,pmid,ti,ab,year,punchline_text,population,interventions,outcomes,population_mesh,interventions_mesh,outcomes_mesh,num_randomized,prob_low_rob,punchline_text,authors,journal,dois
0,32342497,Long-term outcomes of patients treated with rituximab as second-line treatment for adult immune thrombocytopenia - Follow-up of the RITP study.,"RITP was a double-blind randomized, 78-week follow-up trial in which 109 adults with immune thrombocytopenias (ITP) who failed to achieve adequate response to steroids, were randomized to receive rituximab or placebo. Here, we provide the duration of response, splenectomy and mortality rates based on extended follow-up after completion of the RITP study. Extended follow-up data were retrospectively collected for 72 (83%) patients out of the 84 patients who were not splenectomized during the initial RITP study. For the present analysis, median [interquartile range] duration of follow-up after randomization was 72 [62-82] months. Median duration of response among patients who achieved an initial response was significantly longer in patients who received rituximab (8·2 [5·5-16·7] months) as compared to placebo (1·8 [1·3-3·6] months), P = 0·036. Overall, 35 patients underwent splenectomy (13 in the rituximab, and 22 in the placebo arm, P = 0·12). Eleven patients (10%) died during the study: five in the rituximab and six in the placebo arms, including four deaths from severe bleeding. Although most rituximab-treated patients eventually relapsed, a longer duration of response and a trend towards lower splenectomy rate were observed in rituximab-treated patients.",2020,"Overall, 35 patients underwent splenectomy (13 in the rituximab, and 22 in the placebo arm, P = 0·12).","['8·2', '109 adults with immune thrombocytopenias (ITP) who failed to achieve adequate response to steroids', 'Extended follow-up data were retrospectively collected for 72 (83%) patients out of the 84 patients who were not splenectomized during the initial RITP study', '35 patients underwent splenectomy (13 in the rituximab, and 22 in the', 'patients treated with rituximab as second-line treatment for adult immune thrombocytopenia - Follow-up of the RITP study']","['rituximab or placebo', 'rituximab', 'RITP', 'placebo']","['Median duration of response', 'splenectomy rate', 'severe bleeding', 'duration of response, splenectomy and mortality rates']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0242584', 'cui_str': 'Autoimmune thrombocytopenia'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0037995', 'cui_str': 'Splenectomy'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1710038', 'cui_str': 'Second line treatment'}]","[{'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0037995', 'cui_str': 'Splenectomy'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",109.0,0.276183,"Overall, 35 patients underwent splenectomy (13 in the rituximab, and 22 in the placebo arm, P = 0·12).","[{'ForeName': 'Eirik', 'Initials': 'E', 'LastName': 'Tjønnfjord', 'Affiliation': 'Division of internal medicine, Østfold hospital, Sarpsborg, Norway.'}, {'ForeName': 'Pål André', 'Initials': 'PA', 'LastName': 'Holme', 'Affiliation': 'Department of Hematology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Bernadette', 'Initials': 'B', 'LastName': 'Darne', 'Affiliation': 'Monitoring Force, Maisons Laffitte, France.'}, {'ForeName': 'Abderrahim', 'Initials': 'A', 'LastName': 'Khelif', 'Affiliation': 'Department of Hematology, CHU Farhat Hached, Université de Sousse, Tunisia.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Waage', 'Affiliation': 'Department of Hematology, St. Olavs Hospital/NTNU, Trondheim, Norway.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Michel', 'Affiliation': 'Department of Internal Medicine, Henri Mondor University Hospital, Université Paris-Est Créteil, Assistance Publique Hôpitaux de Paris, Creteil, France.'}, {'ForeName': 'Neila', 'Initials': 'N', 'LastName': 'Ben Romdhan', 'Affiliation': 'Department of Medicine, La Rabta Hospital, Tunis, Tunisia.'}, {'ForeName': 'Waleed', 'Initials': 'W', 'LastName': 'Ghanima', 'Affiliation': 'Division of internal medicine, Østfold hospital, Sarpsborg, Norway.'}]",British journal of haematology,['10.1111/bjh.16672']
1,32390164,"Thiamidol containing treatment regimens in facial hyperpigmentation: An international multi-centre approach consisting of a double-blind, controlled, split-face study and of an open-label, real-world study.","OBJECTIVE


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


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


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


Four-times daily Thiamidol improves facial hyperpigmentation significantly more than two-times daily and is well tolerated by the subjects. The real-world study with a typical face care regimen containing Thiamidol shows improvement of facial hyperpigmentation and confirms tolerability. Furthermore, the data provide evidence for the suitability of this three-product Thiamidol regimen for day-to-day life.",2020,"In clinical studies, it was shown to improve facial hyperpigmentation, post-inflammatory hyperpigmentation, and age spots significantly.","['subjects with mild-to-moderate facial hyperpigmentation', 'facial hyperpigmentation']",['Thiamidol'],"['tolerated', 'facial hyperpigmentation', 'facial hyperpigmentation, post-inflammatory hyperpigmentation', 'efficacy and tolerability', 'facial hyperpigmentation and confirms tolerability', 'clinical and subjective grading of hyperpigmentation, skin condition, hemi-/modified MASI, chromameter, and clinical photography', 'hyperpigmentation, skin roughness, and hMASI']","[{'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0162834', 'cui_str': 'Hyperpigmentation'}]",[],"[{'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0162834', 'cui_str': 'Hyperpigmentation'}, {'cui': 'C0333616', 'cui_str': 'Postinflammatory hyperpigmentation'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0037274', 'cui_str': 'Disorder of skin'}, {'cui': 'C1285521', 'cui_str': 'Hemi'}, {'cui': 'C0431056', 'cui_str': 'Photography of patient'}, {'cui': 'C0859038', 'cui_str': 'Skin roughness'}]",50000.0,0.0212795,"In clinical studies, it was shown to improve facial hyperpigmentation, post-inflammatory hyperpigmentation, and age spots significantly.","[{'ForeName': 'W G', 'Initials': 'WG', 'LastName': 'Philipp-Dormston', 'Affiliation': 'Hautzentrum Köln, Schillingsrotter Str. 39-41, Köln, 50996, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Vila Echagüe', 'Affiliation': 'Centro de Referencia en Tratamiento Laser, Av. Del Libertador 662, Piso 17, depto. 42, Buenos Aires, Argentina.'}, {'ForeName': 'S H', 'Initials': 'SH', 'LastName': 'Pérez Damonte', 'Affiliation': 'CLAIM, José Bonifacio 717, Buenos Aires, Argentina.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Riedel', 'Affiliation': 'BDF Argentina, Av Triunvirato 2902, Buenos Aires, C1427 AAP CABA, Argentina.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Filbry', 'Affiliation': 'BDF Argentina, Av Triunvirato 2902, Buenos Aires, C1427 AAP CABA, Argentina.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Warnke', 'Affiliation': 'BDF Argentina, Av Triunvirato 2902, Buenos Aires, C1427 AAP CABA, Argentina.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Lofrano', 'Affiliation': 'Beiersdorf AG, Unnastrasse 48, Hamburg, 20245, Germany.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Roggenkamp', 'Affiliation': 'BDF Argentina, Av Triunvirato 2902, Buenos Aires, C1427 AAP CABA, Argentina.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Nippel', 'Affiliation': 'BDF Argentina, Av Triunvirato 2902, Buenos Aires, C1427 AAP CABA, Argentina.'}]",International journal of cosmetic science,['10.1111/ics.12626']
2,32289380,Clinical outcomes in men of diverse ethnic backgrounds with metastatic castration-resistant prostate cancer.,"BACKGROUND


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


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


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


We observed no differences in clinical outcomes by race and ethnic groups in men with mCRPC enrolled on these phase III clinical trials with DP.",2020,"Median PSA PFS were 9.7 months (95% CI 9.4-10), 8.5 months (95% CI 7.6-10) and 10.0 (95% CI 9.5-11.8) in white, black and Asian men, respectively.
","['white, black and Asian men with mCRPC treated with a DP-based regimen', 'men with mCRPC enrolled on these phase III clinical trials with DP', 'black men had 19% lower risk of death than white men with metastatic castration resistant prostate cancer (mCRPC) treated with a', 'Men of Diverse Ethnic s with Metastatic Castration Resistant Prostate Cancer', 'Of 8,820 patients, 7,528 (85%) were white, 500 (6%) were black, 424 were Asian (5%) and 368 (4%) had race unspecified', 'Individual patient data from 8,820 mCRPC men randomized on nine phase III trials to DP-containing regimen were combined']",['docetaxel (D) and prednisone (P)-based regimen'],"['Median PSA PFS', 'Median PFS', 'progression-free survival (PFS), biochemical PFS, ≥50% decline in PSA from baseline and objective response rate (ORR']","[{'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0178415', 'cui_str': 'Raised prostate specific antigen'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]",8820.0,0.269513,"Median PSA PFS were 9.7 months (95% CI 9.4-10), 8.5 months (95% CI 7.6-10) and 10.0 (95% CI 9.5-11.8) in white, black and Asian men, respectively.
","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Halabi', 'Affiliation': 'Duke University Medical Center and Duke University, Durham, USA. Electronic address: susan.halabi@duke.edu.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Dutta', 'Affiliation': 'Old Dominion University, Norfolk, USA.'}, {'ForeName': 'C M', 'Initials': 'CM', 'LastName': 'Tangen', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rosenthal', 'Affiliation': 'The Royal Melbourne Hospital, Parkville, Australia.'}, {'ForeName': 'D P', 'Initials': 'DP', 'LastName': 'Petrylak', 'Affiliation': 'Yale School of Medicine, New Haven, USA.'}, {'ForeName': 'I M', 'Initials': 'IM', 'LastName': 'Thompson', 'Affiliation': 'Christus San Rosa Hospital Medical Center, San Antonio, USA.'}, {'ForeName': 'K N', 'Initials': 'KN', 'LastName': 'Chi', 'Affiliation': 'British Columbia Cancer Agency - Vancouver Centre, Vancouver, Canada.'}, {'ForeName': 'J S', 'Initials': 'JS', 'LastName': 'De Bono', 'Affiliation': 'The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust, Sutton, UK.'}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Araujo', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Logothetis', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, USA.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Eisenberger', 'Affiliation': 'The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore, USA.'}, {'ForeName': 'D I', 'Initials': 'DI', 'LastName': 'Quinn', 'Affiliation': 'University of Southern California Norris Comprehensive Cancer Center, Los Angeles, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Fizazi', 'Affiliation': 'Gustave Roussy, Villejuif, France.'}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Morris', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, USA.'}, {'ForeName': 'C S', 'Initials': 'CS', 'LastName': 'Higano', 'Affiliation': 'University of Washington and Fred Hutchinson Cancer Research Center, Seattle, USA.'}, {'ForeName': 'I F', 'Initials': 'IF', 'LastName': 'Tannock', 'Affiliation': 'Princess Margaret Cancer Centre, University of Toronto, Toronto, Canada.'}, {'ForeName': 'E J', 'Initials': 'EJ', 'LastName': 'Small', 'Affiliation': 'University of California, San Francisco, San Francisco, USA.'}, {'ForeName': 'W K', 'Initials': 'WK', 'LastName': 'Kelly', 'Affiliation': 'Sidney Kimmel Cancer Center at Thomas Jefferson University, Philadelphia, USA.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2020.03.309']
3,32345787,Treatment for vaginal atrophy using microablative fractional CO2 laser: a randomized double-blinded sham-controlled trial.,"OBJECTIVE


The aim of this study was to evaluate the efficacy of vaginal CO2 laser for the treatment of vaginal atrophy compared to the sham procedure.
METHODS


Between June 2016 and May 2017, postmenopausal women with moderate to severe intensity of any vaginal atrophy symptoms (VAS) were invited to participate in the study. A total of 88 women were randomized to receive treatment with either vaginal CO2 laser or sham procedures every 4 weeks for three sessions. Both the participants and the evaluators were blinded to the treatment. Vaginal Health Index (VHI) score (primary outcome), VAS score, and the item for vaginal dryness from the International Consultation on Incontinence Modular Questionnaire-Vaginal Symptoms questionnaire were compared between the two groups by intention-to-treat analysis at 12 weeks after treatment.
RESULTS


Eighty-eight women were enrolled into the study and nine women were lost to follow-up. After 12 weeks of laser treatment, the VHI, VAS, and International Consultation on Incontinence Modular Questionnaire-Vaginal Symptoms (item for vaginal dryness) scores were significantly improved. For VHI and VAS scores the mean difference between the laser group versus the sham group was 1.37 (95% CI: 0.12-2.63), P < 0.001 and -1.52 (95% CI: -2.21 to -0.82), P = 0.03, respectively.
CONCLUSIONS


This study demonstrated that the application of microablative fractional CO2 laser was effective in treating vaginal atrophy. It could be a promising alternative treatment for postmenopausal women with vaginal atrophy. : Video Summary:http://links.lww.com/MENO/A582.",2020,"After 12 weeks of laser treatment, the VHI, VAS, and International Consultation on Incontinence Modular Questionnaire-Vaginal Symptoms (item for vaginal dryness) scores were significantly improved.","['postmenopausal women with moderate to severe intensity of any vaginal atrophy symptoms (VAS', 'Between June 2016 and May 2017', 'Eighty-eight women were enrolled into the study and nine women', 'postmenopausal women with vaginal atrophy', 'A total of 88 women']","[' Video Summary:http://links.lww.com/MENO/A582', 'microablative fractional CO2 laser', 'vaginal CO2 laser']","['Vaginal Health Index (VHI) score (primary outcome), VAS score, and the item for vaginal dryness from the International Consultation on Incontinence Modular Questionnaire-Vaginal Symptoms questionnaire', 'For VHI and VAS scores', 'VHI, VAS, and International Consultation on Incontinence Modular Questionnaire-Vaginal Symptoms (item for vaginal dryness) scores']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0241616', 'cui_str': 'Atrophy of vagina'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4517898', 'cui_str': '88'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0392251', 'cui_str': 'Carbon dioxide laser device'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}]","[{'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0241616', 'cui_str': 'Atrophy of vagina'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0241633', 'cui_str': 'Vaginal dryness'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",88.0,0.201694,"After 12 weeks of laser treatment, the VHI, VAS, and International Consultation on Incontinence Modular Questionnaire-Vaginal Symptoms (item for vaginal dryness) scores were significantly improved.","[{'ForeName': 'Purim', 'Initials': 'P', 'LastName': 'Ruanphoo', 'Affiliation': 'Division of Female Pelvic Medicine and Reconstructive Surgery, Department of Obstetrics and Gynecology, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Suvit', 'Initials': 'S', 'LastName': 'Bunyavejchevin', 'Affiliation': ''}]","Menopause (New York, N.Y.)",['10.1097/GME.0000000000001542']
4,32345788,The Women's Health Initiative trials of menopausal hormone therapy: lessons learned.,"OBJECTIVE


The Women's Health Initiative (WHI) assessed oral conjugated equine estrogens (CEE) taken with or without medroxyprogesterone acetate (MPA) for prevention of chronic disease in postmenopausal women aged 50-79 years.
METHODS


Women with an intact uterus (n = 16,608) were randomized to CEE+ MPA therapy or placebo for a median of 5.6 years; women with hysterectomy (n = 10,739) were randomized to CEE-alone therapy or placebo for a median of 7.2 years. Both cohorts have been followed for 18 years.
RESULTS


In the overall study population (mean age, 63 y), neither estrogen-progestin therapy (EPT) nor estrogen-only therapy prevented coronary heart disease or led to a favorable balance of chronic-disease benefits and risks. Subgroup analyses, however, suggest that timing of hormone therapy (HT) initiation influences the relation between HT and coronary risk, as well as its overall benefit-risk balance, with more favorable effects in women who are younger (age < 60 year) or recently menopausal (within 10 year) than in women who are older or further past the menopausal transition. In younger women who entered the trial of estrogen-only therapy with oophorectomy, the intervention was associated with a significant 32% reduction in all-cause mortality over long-term follow-up.
CONCLUSIONS


WHI findings indicate important differences in HT-related clinical outcomes by age and time since menopause. Systemic HT has an acceptable safety profile for menopause management when initiated among healthy women who are younger (or recently menopausal) and not at elevated risk for cardiovascular disease or breast cancer. Initiation of treatment in older women who are distant from menopause onset, however, should be avoided. Other HT formulations and routes of delivery warrant further study.(WHI clinicaltrials.gov identifier: NCT00000611).",2020,Systemic HT has an acceptable safety profile for menopause management when initiated among healthy women who are younger (or recently menopausal) and not at elevated risk for cardiovascular disease or breast cancer.,"['older women who are distant from menopause onset', 'Women with an intact uterus (n\u200a=\u200a16,608', 'for a median of 5.6 years; women with hysterectomy (n\u200a=\u200a10,739', 'In the overall study population (mean age, 63 y), neither estrogen-progestin therapy (EPT) nor estrogen-only therapy prevented coronary heart disease or led to a favorable balance of chronic-disease benefits and risks', 'women who are younger (age < 60 year) or recently menopausal (within 10 year) than in women who are older or further past the menopausal transition', 'postmenopausal women aged 50-79 years', 'healthy women who are younger (or recently menopausal) and not at elevated risk for cardiovascular disease or breast cancer']","['Systemic HT', 'CEE-alone therapy or placebo', 'oral conjugated equine estrogens (CEE) taken with or without medroxyprogesterone acetate (MPA', 'CEE+ MPA therapy or placebo', 'menopausal hormone therapy']",['cause mortality'],"[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0443203', 'cui_str': 'Distant'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C4517794', 'cui_str': '5.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0020699', 'cui_str': 'Hysterectomy'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0014939', 'cui_str': 'Estrogens'}, {'cui': 'C0279495', 'cui_str': 'Progestogen hormone therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0687742', 'cui_str': 'Risks and Benefits'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C0301869', 'cui_str': 'Conjugate'}, {'cui': 'C0019944', 'cui_str': 'Equus caballus'}, {'cui': 'C0014939', 'cui_str': 'Estrogens'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0065864', 'cui_str': 'Medroxyprogesterone acetate'}, {'cui': 'C0282402', 'cui_str': 'Hormone replacement therapy'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",16608.0,0.209041,Systemic HT has an acceptable safety profile for menopause management when initiated among healthy women who are younger (or recently menopausal) and not at elevated risk for cardiovascular disease or breast cancer.,"[{'ForeName': 'JoAnn E', 'Initials': 'JE', 'LastName': 'Manson', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School.""}, {'ForeName': 'Shari S', 'Initials': 'SS', 'LastName': 'Bassuk', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School.""}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Kaunitz', 'Affiliation': 'University of Florida College of Medicine Jacksonville, Jacksonville, FL.'}, {'ForeName': 'JoAnn V', 'Initials': 'JV', 'LastName': 'Pinkerton', 'Affiliation': 'Division of Midlife Health, University of Virginia Health System, Charlottesville, VA.'}]","Menopause (New York, N.Y.)",['10.1097/GME.0000000000001553']
5,32354466,The Efficacy of Distraction Cards and Kaleidoscope for Reducing Pain During Phlebotomy: A Randomized Controlled Trial.,"PURPOSE


The purpose of this study was to determine the efficacy of distraction cards and a kaleidoscope in reducing pain during phlebotomy procedures among children aged 6 to 12.
DESIGN


This randomized controlled study involved intervention groups and a control group.
METHODS


Data were obtained by the use of an information form and the visual analog scale. Data were analyzed with descriptive statistics as well as Kruskal-Wallis, Wilcoxon, and post hoc tests.
FINDINGS


During the phlebotomy, children in the control group experienced more pain than children in the distraction cards group and kaleidoscope group (P < .001). There was no significant difference between pain scores of the two intervention groups (P > .05). Both methods were found to be effective in reducing pain.
CONCLUSIONS


It may be helpful to inform children and parents about the process before procedural interventions. Nurses would likely benefit from education on the use of distraction cards and kaleidoscope to be used during procedural interventions.",2020,"During the phlebotomy, children in the control group experienced more pain than children in the distraction cards group and kaleidoscope group (P < .001).",['children aged 6 to 12'],"['distraction cards and a kaleidoscope', 'Distraction Cards and Kaleidoscope']","['pain scores', 'Pain', 'visual analog scale', 'pain']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0150189', 'cui_str': 'Distraction training'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",,0.0656528,"During the phlebotomy, children in the control group experienced more pain than children in the distraction cards group and kaleidoscope group (P < .001).","[{'ForeName': 'Remziye', 'Initials': 'R', 'LastName': 'Semerci', 'Affiliation': 'Department of Child Health and Disease Nursing, Faculty of Health Sciences, Trakya University, Edirne, Turkey. Electronic address: remziyesemerci@gmail.com.'}, {'ForeName': 'Melahat', 'Initials': 'M', 'LastName': 'Akgün Kostak', 'Affiliation': 'Department of Child Health and Disease Nursing, Faculty of Health Sciences, Trakya University, Edirne, Turkey.'}]",Journal of perianesthesia nursing : official journal of the American Society of PeriAnesthesia Nurses,['10.1016/j.jopan.2020.02.003']
6,32357109,Text Message Intervention for Teens with Type 1 Diabetes Preserves HbA1c: Results of a Randomized Controlled Trial.,"Aims : Teens with type 1 diabetes (T1D) often struggle with diabetes self-management, which may lead to suboptimal self-care and worsening hemoglobin A1c (HbA1c). Innovative strategies are needed to improve self-care and protect against glycemic decline, especially during adolescence. We aimed to assess the impact on HbA1c of two interventions, problem-solving and text messaging, in teens with T1D.  Methods : In a two-site randomized controlled trial, teens ( N  = 301) 13-17 years of age with T1D were randomized to one of the four groups using a 2 × 2 factorial design: Teenwork (TW), Text Messaging (Text), TW+Text, or Usual Care. TW intervention included problem-solving aimed at improving T1D self-care for blood glucose (BG) monitoring and insulin bolus dosing. Text intervention involved text reminders to check BG. The primary outcome was change in HbA1c from baseline to 12 months.  Results : At baseline, teens (51% female, 78% white, 59% pump-treated) were (mean ± SD) 15.0 ± 1.3 years, had diabetes duration of 6.5 ± 3.7 years, and HbA1c 8.5% ± 1.1%. There was no significant difference in HbA1c over time by study group. Responsiveness to text reminders by teens in the TEXT and TW+TEXT predicted glycemic benefit; TW did not.  Conclusions : Despite no HbA1c difference by study group, greater response to text message reminders to check BG led to better glycemic control and no deterioration in HbA1c; the problem-solving intervention did not. Given the high penetration of mobile phones and the wide acceptance of text messaging among teens in general, it is encouraging that a text messaging intervention can preserve HbA1c, thus preventing the expected deterioration in glycemic control often seen in teens with T1D.",2020,Responsiveness to text reminders by teens in the TEXT and TW+TEXT,"['Aims : Teens with type 1 diabetes (T1D) often struggle with diabetes self-management, which may lead to suboptimal self-care and worsening hemoglobin A1c (HbA1c', 'teens with T1D.  Methods ', 'Teens with Type 1 Diabetes', '15.0\u2009±\u20091.3 years, had diabetes duration of 6.5\u2009±\u20093.7 years, and HbA1c 8.5%\u2009±\u20091.1', 'teens ( N \u2009=\u2009301) 13-17 years of age with T1D', 'teens with T1D']","['TW intervention included problem-solving aimed at improving T1D self-care for blood glucose (BG) monitoring and insulin bolus dosing', 'Text Message Intervention', 'Teenwork (TW), Text Messaging (Text), TW+Text, or Usual Care', 'TW+TEXT']","['HbA1c', 'change in HbA1c']","[{'cui': 'C2744535', 'cui_str': 'CD69 protein, human'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011854', 'cui_str': 'Type 1 diabetes mellitus'}, {'cui': 'C1319140', 'cui_str': 'Diabetes self-management behavior'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4517499', 'cui_str': '1.3'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C4517696', 'cui_str': '3.7'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C4517491', 'cui_str': '1.1'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0033211', 'cui_str': 'Problem solving'}, {'cui': 'C2744535', 'cui_str': 'CD69 protein, human'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0011854', 'cui_str': 'Type 1 diabetes mellitus'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C3178908', 'cui_str': 'Texting'}]","[{'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",,0.0948385,Responsiveness to text reminders by teens in the TEXT and TW+TEXT,"[{'ForeName': 'Dayna E', 'Initials': 'DE', 'LastName': 'McGill', 'Affiliation': 'Section on Clinical, Behavioral, and Outcomes Research, Pediatric, Adolescent, and Young Adult Section, Joslin Diabetes Center, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Lori M', 'Initials': 'LM', 'LastName': 'Laffel', 'Affiliation': 'Section on Clinical, Behavioral, and Outcomes Research, Pediatric, Adolescent, and Young Adult Section, Joslin Diabetes Center, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Lisa K', 'Initials': 'LK', 'LastName': 'Volkening', 'Affiliation': 'Section on Clinical, Behavioral, and Outcomes Research, Pediatric, Adolescent, and Young Adult Section, Joslin Diabetes Center, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Deborah A', 'Initials': 'DA', 'LastName': 'Butler', 'Affiliation': 'Section on Clinical, Behavioral, and Outcomes Research, Pediatric, Adolescent, and Young Adult Section, Joslin Diabetes Center, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Wendy L', 'Initials': 'WL', 'LastName': 'Levy', 'Affiliation': ""Texas Children's Hospital, Baylor College of Medicine, Houston, Texas.""}, {'ForeName': 'Rachel M', 'Initials': 'RM', 'LastName': 'Wasserman', 'Affiliation': ""Texas Children's Hospital, Baylor College of Medicine, Houston, Texas.""}, {'ForeName': 'Barbara J', 'Initials': 'BJ', 'LastName': 'Anderson', 'Affiliation': ""Texas Children's Hospital, Baylor College of Medicine, Houston, Texas.""}]",Diabetes technology & therapeutics,['10.1089/dia.2019.0350']
7,32357362,Randomised controlled trial: Can topical timolol maleate prevent complications for small superficial infantile haemangiomata in high-risk areas?,"BACKGROUND


To define the role of topical timolol maleate (TTM) in the treatment of infantile haemangiomata (IH).
METHODS


In this single-centre randomised controlled trial, we included all <1-year-old infants within a 13-month period presenting with small (<2 cm) superficial IH located at high-risk areas (i.e. tip of ears, tip of nose, eyelids, acral areas, facial areas, scalp, neck, buttocks, perineum and axilla). Patients either received 12 months of 0.5% TTM solution (study group) or watchful waiting (control group). The primary outcome was IH with development of complications that required additional interventions. The secondary outcomes included side effects of TTM and change in IH size.
RESULTS


Forty-two children were eligible to the study. Patients who received TTM were noted to have significantly fewer complications than the control group (4.2% versus 29%, odds ratio 9.58 [95% confidence interval: 1.01-91.62], p = 0.04). Mean IH volume percentage reduction was significantly more for the TTM group and no-TTM group at 3, 6 and 12 months.
CONCLUSIONS


TTM is an effective and safe treatment option to reduce complications, IH volume and the need for further intervention for infants with small superficial IH located at high-risk areas.
IMPACT


There is a lack of reliable signs to predict ulceration, disfigurement and other complications for high-risk IH. Treatment options range from watchful waiting to early systemic treatment, with TTM a novel and promising treatment. The exact role of TTM remains unanswered due to a lack of evidence-based research. TTM is effective and safe for infants with superficial IH of <2 cm in high-risk areas. Early TTM use on IH can reduce complications, IH volume and the need for further treatment.",2020,"Mean IH volume percentage reduction was significantly more for the TTM group and no-TTM group at 3, 6 and 12 months.
","['all <1-year-old infants within a 13-month period presenting with small (<2\u2009cm) superficial IH located at high-risk areas (i.e. tip of ears, tip of nose, eyelids, acral areas, facial areas, scalp, neck, buttocks, perineum and axilla', 'infantile haemangiomata (IH', 'Forty-two children were eligible to the study', 'infants with small superficial IH located at high-risk areas']","['TTM solution (study group) or watchful waiting (control group', 'TTM', 'timolol maleate', 'topical timolol maleate (TTM']","['Mean IH volume percentage reduction', 'side effects of TTM and change in IH size', 'complications', 'IH with development of complications that required additional interventions']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C0231330', 'cui_str': 'Infancy'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0339897', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}, {'cui': 'C0013443', 'cui_str': 'Ear structure'}, {'cui': 'C0225409', 'cui_str': 'Structure of apex of nose'}, {'cui': 'C0015426', 'cui_str': 'Eyelid structure'}, {'cui': 'C0439746', 'cui_str': 'Acral'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0036270', 'cui_str': 'Scalp structure'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0006497', 'cui_str': 'Buttock structure'}, {'cui': 'C0031066', 'cui_str': 'Perineal'}, {'cui': 'C0004454', 'cui_str': 'Axillary'}, {'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0087093', 'cui_str': 'Timolol maleate'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0700325', 'cui_str': 'Patient status observation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0231330', 'cui_str': 'Infancy'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0087093', 'cui_str': 'Timolol maleate'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C1331475', 'cui_str': 'Has development'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",42.0,0.200241,"Mean IH volume percentage reduction was significantly more for the TTM group and no-TTM group at 3, 6 and 12 months.
","[{'ForeName': 'James W C H', 'Initials': 'JWCH', 'LastName': 'Cheng', 'Affiliation': 'Department of Paediatrics and Adolescent Medicine, United Christian Hospital, Hong Kong SAR, China. cch278@ha.org.hk.'}, {'ForeName': 'Ying-Yin', 'Initials': 'YY', 'LastName': 'Lam', 'Affiliation': 'Department of Paediatrics and Adolescent Medicine, United Christian Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Genevieve P G', 'Initials': 'GPG', 'LastName': 'Fung', 'Affiliation': 'Department of Paediatrics and Adolescent Medicine, United Christian Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Conor', 'Initials': 'C', 'LastName': 'Sin', 'Affiliation': 'Department of Paediatrics and Adolescent Medicine, United Christian Hospital, Hong Kong SAR, China.'}, {'ForeName': 'David C K', 'Initials': 'DCK', 'LastName': 'Luk', 'Affiliation': 'Department of Paediatrics and Adolescent Medicine, United Christian Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Bill H B', 'Initials': 'BHB', 'LastName': 'Chan', 'Affiliation': ""Hong Kong Children's Hospital, Hong Kong SAR, China.""}, {'ForeName': 'Wa-Keung', 'Initials': 'WK', 'LastName': 'Chiu', 'Affiliation': 'Department of Paediatrics and Adolescent Medicine, United Christian Hospital, Hong Kong SAR, China.'}]",Pediatric research,['10.1038/s41390-020-0917-3']
8,32363771,Population pharmacokinetics of adalimumab biosimilar adalimumab-adbm and reference product in healthy subjects and patients with rheumatoid arthritis to assess pharmacokinetic similarity.,"AIMS


Adalimumab-adbm is a monoclonal antibody developed as a biosimilar to adalimumab (Humira, AbbVie Inc.). The key objectives of this study were using a population pharmacokinetic (PPK) approach to assess pharmacokinetic (PK) similarity between adalimumab-adbm and Humira in patients with active rheumatoid arthritis (RA), to quantify the effects of potential covariates on adalimumab PK and to assess the impact of switching treatment from Humira to adalimumab-adbm on PK.
METHODS


A PPK model was firstly developed using intensive PK data from the phase-1 study in healthy subjects (NCT02045979). PPK models were developed separately for phase-3 base study (NCT02137226) and its extension study (NCT02640612) in patients with active RA.
RESULTS


PPK models were developed for adalimumab from adalimumab-adbm and Humira treatment in healthy subjects and RA patients. Weight and anti-drug antibodies were found to be important predictors of adalimumab clearance. Adalimumab PK was similar between adalimumab-adbm and Humira. The estimated effect of Humira on clearance, relative to the adalimumab-adbm, was 1.02 (i.e., Humira has 0.02 greater clearance). Similarly, the effect of treatment arms (switching) on clearance was estimated to be 1.00 and 0.997 for Humira:Humira:BI and Humira:BI:BI arms, respectively, relative to the BI:BI:BI arm (BI refers to adalimumab-adbm) in the phase-3 extension study.
CONCLUSION


PK similarity between adalimumab-adbm and Humira in patients with active RA was demonstrated using PPK approach. Adalimumab PK was also similar when switching treatment from Humira to adalimumab-adbm at either week 24 or 48.",2020,Adalimumab PK was also similar when switching treatment from Humira to adalimumab-adbm at either week 24 or 48.,"['healthy subjects and patients with rheumatoid arthritis', 'patients with active rheumatoid arthritis (RA', 'patients with active RA', 'healthy subjects and RA patients', 'healthy subjects (NCT02045979']","['Adalimumab PK', 'adalimumab biosimilar adalimumab-adbm', 'adalimumab-adbm and Humira']","['pharmacokinetic (PK) similarity', 'Weight and anti-drug antibodies (ADA', 'clearance']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C4045974', 'cui_str': 'Biosimilars'}, {'cui': 'C4530556', 'cui_str': 'Adalimumab-adbm'}, {'cui': 'C1171255', 'cui_str': 'Humira'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}]",,0.0232379,Adalimumab PK was also similar when switching treatment from Humira to adalimumab-adbm at either week 24 or 48.,"[{'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Kang', 'Affiliation': 'Metrum Research Group, Tariffville, Connecticut, USA.'}, {'ForeName': 'Rena J', 'Initials': 'RJ', 'LastName': 'Eudy-Byrne', 'Affiliation': 'Metrum Research Group, Tariffville, Connecticut, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Mondick', 'Affiliation': 'Metrum Research Group, Tariffville, Connecticut, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Knebel', 'Affiliation': 'Metrum Research Group, Tariffville, Connecticut, USA.'}, {'ForeName': 'Girish', 'Initials': 'G', 'LastName': 'Jayadeva', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Karl-Heinz', 'Initials': 'KH', 'LastName': 'Liesenfeld', 'Affiliation': 'Boehringer Ingelheim International GmbH, Biberach, an der Riss, Germany.'}]",British journal of clinical pharmacology,['10.1111/bcp.14330']
9,32358836,Cost-effectiveness evaluation of the PROPPR trial transfusion protocols.,"BACKGROUND


There have been no prior investigations of the cost effectiveness of transfusion strategies for trauma resuscitation. The Pragmatic, Randomized, Optimal Platelet and Plasma Ratios (PROPPR) study was a Phase III multisite, randomized trial in 680 subjects comparing the efficacy of 1:1:1 transfusion ratios of plasma and platelets to red blood cells with the 1:1:2 ratio. We hypothesized that 1:1:1 transfusion results in an acceptable incremental cost-effectiveness ratio, when estimated using patients' age-specific life expectancy and cost of care during the 30-day PROPPR trial period.
STUDY DESIGN AND METHODS


International Classification of Diseases, Ninth Revision codes were prospectively collected, and subjects were matched 1:2 to subjects in the Healthcare Utilization Program State Inpatient Data to estimate cost weights. We used a decision tree analysis, combined with standard costs and estimated years of expected survival to determine the cost effectiveness of the two treatments.
RESULTS


The 1:1:1 group had higher overall costs for the blood products but were more likely to achieve hemostasis and decreased hemorrhagic death by 24 hours (p = 0.006). For every 100 patients treated in the 1:1:1 group, eight more achieved hemostasis than in the 1:1:2 group. At 30 days, the total hospital cost per 100 patients was $5.6 million in the 1:1:1 group compared with $5.0 million in the 1:1:2 group. For each 100 patients, the 1:1:1 group had 218.5 more years of life expectancy. This was at a cost of $2994 per year gained.
CONCLUSION


The 1:1:1 transfusion ratio in severely injured hemorrhaging trauma patients is a very cost-effective strategy for increasing hemostasis and decreasing trauma deaths.",2020,The 1:1:1 group had higher overall costs for the blood products but were more likely to achieve hemostasis and decreased hemorrhagic death by 24 hours (p = 0.006).,"['severely injured hemorrhaging trauma patients', '680 subjects', 'International Classification of Diseases, Ninth Revision codes were prospectively collected, and subjects were matched 1:2 to subjects in the Healthcare Utilization Program State Inpatient Data to estimate cost weights']",[],"['hemostasis', 'overall costs', 'hemorrhagic death', 'total hospital cost', 'life expectancy']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0870733', 'cui_str': 'International Statistical Classification of Diseases and Related Health Problems'}, {'cui': 'C0205443', 'cui_str': 'Ninth'}, {'cui': 'C0439616', 'cui_str': 'Revisions'}, {'cui': 'C0009219', 'cui_str': 'Coding'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]",[],"[{'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0206174', 'cui_str': 'Cost, Hospital'}, {'cui': 'C0023671', 'cui_str': 'Life Expectancy'}]",680.0,0.0809202,The 1:1:1 group had higher overall costs for the blood products but were more likely to achieve hemostasis and decreased hemorrhagic death by 24 hours (p = 0.006).,"[{'ForeName': 'Rachael A', 'Initials': 'RA', 'LastName': 'Callcut', 'Affiliation': 'Division of General Surgery, Department of Surgery, School of Medicine, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Kit N', 'Initials': 'KN', 'LastName': 'Simpson', 'Affiliation': 'Department of Healthcare Leadership & Management, Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Baraniuk', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Texas Health Science Center at Houston, Houston, Texas, USA.'}, {'ForeName': 'Erin E', 'Initials': 'EE', 'LastName': 'Fox', 'Affiliation': 'Center for Translational Injury Research and Department of Surgery, University of Texas Health Science Center at Houston, Houston, Texas, USA.'}, {'ForeName': 'Barbara C', 'Initials': 'BC', 'LastName': 'Tilley', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Texas Health Science Center at Houston, Houston, Texas, USA.'}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Holcomb', 'Affiliation': 'Division of Acute Care Surgery, Department of Surgery, Center for Injury Science, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Transfusion,['10.1111/trf.15784']
10,32352320,IMbrave 050: a Phase III trial of atezolizumab plus bevacizumab in high-risk hepatocellular carcinoma after curative resection or ablation.,"Hepatocellular carcinoma recurs in 70-80% of cases following potentially curative resection or ablation and the immune component of the liver microenvironment plays a key role in recurrence. Many immunosuppressive mechanisms implicated in HCC recurrence are modulated by VEGF and/or immune checkpoints such as PD-L1. Atezolizumab (PD-L1 inhibitor) plus bevacizumab (VEGF inhibitor) has been shown to significantly improve overall survival, progression-free survival and overall response rate in unresectable HCC. Dual PD-L1/VEGF blockade may be effective in reducing HCC recurrence by creating a more immune-favorable microenvironment. We describe the rationale and design of IMbrave 050 (NCT04102098), a randomized, open-label, Phase III study comparing atezolizumab plus bevacizumab versus active surveillance in HCC patients at high-risk of recurrence following curative resection or ablation. The primary end point is recurrence-free survival.  Clinical Trial Registration:  NCT04102098.",2020,Many immunosuppressive mechanisms implicated in HCC recurrence are modulated by VEGF and/or immune checkpoints such as PD-L1.,"['HCC patients at high-risk of recurrence following curative resection or ablation', 'high-risk hepatocellular carcinoma after curative resection or ablation']","['Dual PD-L1/VEGF blockade', 'Atezolizumab (PD-L1 inhibitor) plus bevacizumab (VEGF inhibitor', 'atezolizumab plus bevacizumab']","['overall survival, progression-free survival and overall response rate', 'HCC recurrence', 'recurrence-free survival']","[{'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}]",,0.0781475,Many immunosuppressive mechanisms implicated in HCC recurrence are modulated by VEGF and/or immune checkpoints such as PD-L1.,"[{'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Hack', 'Affiliation': 'Genentech, Inc, 1 DNA Way, South San Francisco, CA 94080, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Spahn', 'Affiliation': 'Genentech, Inc, 1 DNA Way, South San Francisco, CA 94080, USA.'}, {'ForeName': 'Minshan', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'Department of Hepatobiliary Surgery, Cancer Centre of Sun Yat-sen University, Guangzhou, PR China.'}, {'ForeName': 'Ann-Lii', 'Initials': 'AL', 'LastName': 'Cheng', 'Affiliation': 'National Taiwan University Cancer Center & National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Kaseb', 'Affiliation': 'Department of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA.'}, {'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Kudo', 'Affiliation': 'Department of Gastroenterology & Hepatology, Kindai University School of Medicine, Osaka, Japan.'}, {'ForeName': 'Han Chu', 'Initials': 'HC', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Yopp', 'Affiliation': 'Department of Surgery, Division of Surgical Oncology, University of Texas Southwestern Medical Center, Dallas, TX 75390, USA.'}, {'ForeName': 'Pierce', 'Initials': 'P', 'LastName': 'Chow', 'Affiliation': 'Division of Surgical Oncology, National Cancer Centre, Singapore.'}, {'ForeName': 'Shukui', 'Initials': 'S', 'LastName': 'Qin', 'Affiliation': ""PLA Cancer Center, People's Liberation Army (PLA) 81 Hospital, Nanjing 210016, PR China.""}]","Future oncology (London, England)",['10.2217/fon-2020-0162']
11,32349692,Online cognitive behavioral therapy enhanced for binge eating disorder: study protocol for a randomized controlled trial.,"BACKGROUND


Binge eating disorder is characterized by recurrent episodes of binge eating accompanied by a sense of lack of control. Of the different treatments available, Cognitive Behavioral Therapy-Enhanced and guided self-help treatment are recommended. As online treatment offers several additional advantages, we have developed a CBT-Enhanced online guided self-help intervention. The aim of this study is to determine whether this intervention reduces eating disorder pathology and increases the amount of binge free days in adults classified with binge eating disorder or other specified feeding or eating disorder- binge eating disorder, compared to an untreated waiting list condition. The experimental condition is hypothesized to be superior to the waiting list condition.
METHODS


The efficacy of an online guided self-help intervention for binge eating disorder will be assessed by conducting a randomized controlled trial. The trial will target adult individuals classified with binge eating disorder or other specified feeding or eating disorder- binge eating disorder with a body mass index between 19.5 and 40, referred to an eating disorder treatment center. Dual arm allotment will be performed in a 1:1 ratio stratified for BMI above or below 30. Randomization will be blinded to the online intervention (n = 90), or to the control waiting list condition (n = 90). Assessors will be blinded and assessments will be administered at baseline, week 5, at end-of-treatment, and at 12 and 24 weeks follow-up. Primary outcome will be eating disorder pathology, operationalized as number of days on which binge eating occurred between the two conditions during the period of the intervention. Secondary outcome measures will be differences in other eating disorder pathology, clinical impairment and in quality of life, while therapeutic alliance, demographic characteristics and followed treatment module will serve as effect moderators. Several types of costs will be assessed.
DISCUSSION


This paper presents an online guided self-help Cognitive Behavioral Therapy- Enhanced study protocol for individuals classified with binge eating disorder or other specified feeding or eating disorder. Efficacy will be examined through a Randomized Controlled Trial.
TRIAL REGISTRATION


The study protocol is registered with the Netherlands Trial Registry NTR (NTR 7994) since 6 September 2019.",2020,"The aim of this study is to determine whether this intervention reduces eating disorder pathology and increases the amount of binge free days in adults classified with binge eating disorder or other specified feeding or eating disorder- binge eating disorder, compared to an untreated waiting list condition.","['binge eating disorder', 'individuals classified with binge eating disorder or other specified feeding or eating disorder', 'adult individuals classified with binge eating disorder or other specified feeding or eating disorder- binge eating disorder with a body mass index between 19.5 and 40, referred to an eating disorder treatment center', 'adults classified with binge eating disorder or other specified feeding or eating disorder- binge eating disorder']","['Online cognitive behavioral therapy', 'online guided self-help intervention', 'online guided self-help Cognitive Behavioral Therapy- Enhanced study protocol', 'Cognitive Behavioral Therapy-Enhanced and guided self-help treatment']","['eating disorder pathology, clinical impairment and in quality of life, while therapeutic alliance, demographic characteristics and followed treatment module will serve as effect moderators', 'eating disorder pathology, operationalized as number of days on which binge eating', 'eating disorder pathology']","[{'cui': 'C0596170', 'cui_str': 'Binge eating disorder'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0013473', 'cui_str': 'Eating disorder'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2733435', 'cui_str': 'Guided self-help cognitive behavioral therapy'}, {'cui': 'C2599718', 'cui_str': 'Clinical Trial Protocols'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0013473', 'cui_str': 'Eating disorder'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0814487', 'cui_str': 'Therapeutic Alliance'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0006370', 'cui_str': 'Binge Eating'}]",,0.157499,"The aim of this study is to determine whether this intervention reduces eating disorder pathology and increases the amount of binge free days in adults classified with binge eating disorder or other specified feeding or eating disorder- binge eating disorder, compared to an untreated waiting list condition.","[{'ForeName': 'Elske', 'Initials': 'E', 'LastName': 'van den Berg', 'Affiliation': 'Novarum Center for Eating Disorders & Obesity, Jacob Obrechtstraat 92, 1071, KR, Amsterdam, the Netherlands.'}, {'ForeName': 'Bernou', 'Initials': 'B', 'LastName': 'Melisse', 'Affiliation': 'Novarum Center for Eating Disorders & Obesity, Jacob Obrechtstraat 92, 1071, KR, Amsterdam, the Netherlands. bernou.melisse@novarum.nl.'}, {'ForeName': 'Jitske', 'Initials': 'J', 'LastName': 'Koenders', 'Affiliation': 'Novarum Center for Eating Disorders & Obesity, Jacob Obrechtstraat 92, 1071, KR, Amsterdam, the Netherlands.'}, {'ForeName': 'Margo', 'Initials': 'M', 'LastName': 'de Jonge', 'Affiliation': 'Novarum Center for Eating Disorders & Obesity, Jacob Obrechtstraat 92, 1071, KR, Amsterdam, the Netherlands.'}, {'ForeName': 'Matthijs', 'Initials': 'M', 'LastName': 'Blankers', 'Affiliation': 'Research Department, Arkin Mental Health Institute, Klaprozenweg 111, 1033, NN, Amsterdam, the Netherlands.'}, {'ForeName': 'Edwin', 'Initials': 'E', 'LastName': 'de Beurs', 'Affiliation': 'Research Department, Arkin Mental Health Institute, Klaprozenweg 111, 1033, NN, Amsterdam, the Netherlands.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Dekker', 'Affiliation': 'Research Department, Arkin Mental Health Institute, Klaprozenweg 111, 1033, NN, Amsterdam, the Netherlands.'}]",BMC psychiatry,['10.1186/s12888-020-02604-1']
12,32349698,Mindfulness-based crisis interventions (MBCI) for psychosis within acute inpatient psychiatric settings; a feasibility randomised controlled trial.,"BACKGROUND


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


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


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


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


ISRCTN37625384.",2020,"Delivering a brief mindfulness-based inpatient intervention for psychosis is feasible and acceptable, and may reduce risk of short-term readmission.","['psychosis within acute inpatient psychiatric settings', 'inpatients with psychosis', 'Fifty participants were recruited (26 MBCI; 24 SAT', 'eligible inpatients with psychotic symptoms']","['control intervention (Social Activity Therapy; SAT', 'Mindfulness-Based Crisis Intervention; MBCI', 'Mindfulness-based crisis interventions (MBCI', 'mindfulness-based intervention']","['feasibility and acceptability', 're-admission rates', 'adverse events', 'readmission rate, at 6 and 12\u2009months (m) post discharge, and self-report symptom measures']","[{'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0748064', 'cui_str': 'Psychiatric in-patient'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0871189', 'cui_str': 'Psychotic symptom'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0150123', 'cui_str': 'Activity care'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0010332', 'cui_str': 'Crisis intervention'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",50.0,0.156213,"Delivering a brief mindfulness-based inpatient intervention for psychosis is feasible and acceptable, and may reduce risk of short-term readmission.","[{'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Jacobsen', 'Affiliation': ""Department of Psychology, King's College London, Institute of Psychiatry, Psychology and Neuroscience (IoPPN), De Crespigny Park, London, SE5 8AF, UK. pcj25@bath.ac.uk.""}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Peters', 'Affiliation': ""Department of Psychology, King's College London, Institute of Psychiatry, Psychology and Neuroscience (IoPPN), De Crespigny Park, London, SE5 8AF, UK.""}, {'ForeName': 'Emily J', 'Initials': 'EJ', 'LastName': 'Robinson', 'Affiliation': ""Department of Biostatistics & Health Informatics, King's College London, Institute of Psychiatry, Psychology and Neuroscience (IoPPN), De Crespigny Park, London, SE5 8AF, UK.""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Chadwick', 'Affiliation': ""Department of Psychology, King's College London, Institute of Psychiatry, Psychology and Neuroscience (IoPPN), De Crespigny Park, London, SE5 8AF, UK.""}]",BMC psychiatry,['10.1186/s12888-020-02608-x']
13,32353162,"Safety and pharmacokinetic profiles of MGS0274 besylate (TS-134), a novel metabotropic glutamate 2/3 receptor agonist prodrug, in healthy subjects.","AIMS


The safety and pharmacokinetics of single and multiple doses of a novel mGlu 2/3  receptor agonist prodrug, MGS0274 besylate (TS-134), were investigated in healthy subjects.
METHODS


Phase 1 single-ascending dose (5-20 mg) and multiple-ascending dose titration (5-80 mg) studies were conducted in healthy male and female subjects. Both studies were randomized, double-blinded and placebo-controlled. In one cohort of single-ascending dose study (10 mg), concentrations of MGS0008, the active compound, in the cerebrospinal fluid (CSF) were measured for up to 24 hours postdose.
RESULTS


Following single and multiple oral administrations, MGS0274 was rapidly absorbed and extensively converted into MGS0008, which reached a maximum concentration (C max  ) in plasma within 4 hours postdose and declined with a terminal half-life (t 1/2  ) of around 10 hours. Plasma exposure to MGS0274 was minimal, accounting for approximately 3% of the area under the concentration-time curve (AUC) of MGS0008. Plasma C max  and AUC of MGS0008 at steady state increased dose proportionally (5-80 mg). MGS0008 penetrated into CSF, with a CSF-to-plasma C max  ratio of 3.66%, and was eliminated with a t 1/2  of approximately 16 hours. The most frequent treatment-emergent adverse events observed following single and multiple oral administration included headache, nausea, somnolence, dizziness and vomiting.
CONCLUSION


TS-134 is orally bioavailable in humans and converts rapidly and extensively to MGS0008, which exhibits good CSF penetration. Orally administered TS-134 was safe and generally well-tolerated; hence, TS-134 is a promising candidate for further clinical development for the treatment of disorders in which glutamatergic abnormalities are involved, such as schizophrenia.",2020,Plasma C max  and AUC of MGS0008 at steady state increased dose proportionally (5-80 mg).,"['healthy male and female subjects', 'healthy subjects', 'Healthy Subjects']","['TS-134', 'novel mGlu 2/3  receptor agonist prodrug, MGS0274 besylate (TS-134', 'MGS0274 Besylate (TS-134', 'single-ascending dose (SAD; 5-20 mg) and multiple-ascending dose titration (MAD', 'placebo']","['Plasma C max  and AUC of MGS0008', 'maximum concentration (C max  ) in plasma', 'headache, nausea, somnolence, dizziness and vomiting']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C2987634', 'cui_str': 'Receptor agonist'}, {'cui': 'C0033262', 'cui_str': 'Drug Precursors'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205385', 'cui_str': 'Ascending'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0963196', 'cui_str': 'MGS 0008'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}]",,0.0852044,Plasma C max  and AUC of MGS0008 at steady state increased dose proportionally (5-80 mg).,"[{'ForeName': 'Mai', 'Initials': 'M', 'LastName': 'Watanabe', 'Affiliation': 'Taisho Pharmaceutical R&D Inc., NJ, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Marcy', 'Affiliation': 'Taisho Pharmaceutical R&D Inc., NJ, USA.'}, {'ForeName': 'Kohnosuke', 'Initials': 'K', 'LastName': 'Kinoshita', 'Affiliation': 'Taisho Pharmaceutical Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Misako', 'Initials': 'M', 'LastName': 'Fukasawa', 'Affiliation': 'Taisho Pharmaceutical Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Hirohiko', 'Initials': 'H', 'LastName': 'Hikichi', 'Affiliation': 'Taisho Pharmaceutical Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Shigeyuki', 'Initials': 'S', 'LastName': 'Chaki', 'Affiliation': 'Taisho Pharmaceutical Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Shigeru', 'Initials': 'S', 'LastName': 'Okuyama', 'Affiliation': 'Taisho Pharmaceutical Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Hakop', 'Initials': 'H', 'LastName': 'Gevorkyan', 'Affiliation': 'California Clinical Trials Medical Group, CA, USA.'}, {'ForeName': 'Shigeru', 'Initials': 'S', 'LastName': 'Yoshida', 'Affiliation': 'Taisho Pharmaceutical Co., Ltd., Tokyo, Japan.'}]",British journal of clinical pharmacology,['10.1111/bcp.14331']
14,32359042,"Efficacy of the eCHECKUP TO GO for High School Seniors: Sex Differences in Risk Factors, Protective Behavioral Strategies, and Alcohol Use.","OBJECTIVE


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


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


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


Results of this study extend the literature by demonstrating the efficacy of the eCHECKUP TO GO for both males and females on reducing cognitive risk factors and alcohol use, although results were significant for a broader range of variables for females. Results also indicate that program content regarding normative feedback and protective behavioral strategies may need modification to be more effective for this age group.",2020,"In contrast, we did not find evidence for sex as a moderator of intervention effects for normative perceptions of peer drinking frequency, sex-specific perceptions of peer heavy episodic drinking, positive alcohol expectancies, or peak drinking quantity.","['High School Seniors', 'Participants (n = 311) were high school seniors randomized by class period to the', 'high school seniors']","['eCHECKUP TO GO intervention or assessment-only control group', 'web-based personalized feedback intervention (eCHECKUP TO GO', 'eCHECKUP TO GO']","['normative perceptions of peer drinking, positive alcohol expectancies, and alcohol use relative']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0456387', 'cui_str': 'Class'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0080103', 'cui_str': 'Relative'}]",311.0,0.0172365,"In contrast, we did not find evidence for sex as a moderator of intervention effects for normative perceptions of peer drinking frequency, sex-specific perceptions of peer heavy episodic drinking, positive alcohol expectancies, or peak drinking quantity.","[{'ForeName': 'Diana M', 'Initials': 'DM', 'LastName': 'Doumas', 'Affiliation': 'Institute for the Study of Behavioral Health and Addiction, Boise State University, Boise, Idaho.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Esp', 'Affiliation': 'Institute for the Study of Behavioral Health and Addiction, Boise State University, Boise, Idaho.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Turrisi', 'Affiliation': 'Biobehavioral Health and Prevention Research Center, The Pennsylvania State University, University Park, Pennsylvania.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Bond', 'Affiliation': 'Biomolecular Research Center, Boise State University, Boise, Idaho.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Flay', 'Affiliation': 'Initiative for Healthy Schools, Boise State University, Boise, Idaho.'}]",Journal of studies on alcohol and drugs,[]
15,32366996,One week of levofloxacin plus dexamethasone eye drops for cataract surgery: an innovative and rational therapeutic strategy.,"BACKGROUND


Cataract surgery is the most common operation performed worldwide. A fixed topical corticosteroid-antibiotic combination is usually prescribed in clinical practice for 2 or more weeks to treat post surgical inflammation and prevent infection. However, this protracted schedule may increase the incidence of corticosteroid-related adverse events and notably promote antibiotic resistance.
METHODS


This International, multicentre, randomized, blinded-assessor, parallel-group clinical study evaluated the non-inferiority of 1-week levofloxacin/dexamethasone eye drops, followed by 1-week dexamethasone alone, vs. 2-week gold-standard tobramycin/dexamethasone (one drop QID for all schedules) to prevent and treat ocular inflammation and prevent infection after uncomplicated cataract surgery. Non-inferiority was defined as the lower limit of the 95% confidence interval (CI) around a treatment difference >-10%. The study randomized 808 patients enrolled in 53 centres (Italy, Germany, Spain and Russia). The primary endpoint was the proportion of patients without anterior chamber inflammation on day 15 defined as the end of treatment. Endophthalmitis was the key secondary endpoint. This study is registered with EudraCT code: 2018-000286-36.
RESULTS


After the end of treatment, 95.2% of the patients in the test arm vs. 94.9% of the control arm had no signs of inflammation in the anterior chamber (difference between proportions of patients = 0.028; 95% CI: -0.0275/0.0331). No case of endophthalmitis was reported. No statistically significant difference was evident in any of the other secondary endpoints. Both treatments were well tolerated.
CONCLUSIONS


Non-inferiority of the new short pharmacological strategy was proven. One week of levofloxacin/dexamethasone prevents infection, ensures complete control of inflammation in almost all patients and may contain antibiotic resistance.",2020,No statistically significant difference was evident in any of the other secondary endpoints.,"['uncomplicated cataract surgery', 'cataract surgery', '808 patients enrolled in 53 centres (Italy, Germany, Spain and Russia']","['levofloxacin/dexamethasone', 'dexamethasone alone, vs. 2-week gold-standard tobramycin/dexamethasone', 'levofloxacin plus dexamethasone']","['signs of inflammation in the anterior chamber', 'proportion of patients without anterior chamber inflammation', 'tolerated', 'Endophthalmitis', 'complete control of inflammation']","[{'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0035970', 'cui_str': 'Russian federation - Europe'}]","[{'cui': 'C0282386', 'cui_str': 'Levofloxacin'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0040341', 'cui_str': 'Tobramycin'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0003151', 'cui_str': 'Anterior chamber of eye structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1096278', 'cui_str': 'Anterior chamber inflammation'}, {'cui': 'C0014236', 'cui_str': 'Endophthalmitis'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",808.0,0.284431,No statistically significant difference was evident in any of the other secondary endpoints.,"[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Bandello', 'Affiliation': 'University Vita-Salute, Milan, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Coassin', 'Affiliation': 'University Campus Bio-Medico, Rome, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Di Zazzo', 'Affiliation': 'University Campus Bio-Medico, Rome, Italy.'}, {'ForeName': 'Stanislao', 'Initials': 'S', 'LastName': 'Rizzo', 'Affiliation': 'A.O.U. Careggi, Florence, Italy.'}, {'ForeName': 'Ilaria', 'Initials': 'I', 'LastName': 'Biagini', 'Affiliation': 'A.O.U. Careggi, Florence, Italy.'}, {'ForeName': 'Nadezhda', 'Initials': 'N', 'LastName': 'Pozdeyeva', 'Affiliation': 'Eye Microsurgery Federal State Institution, Cheboksary, Russian Federation.'}, {'ForeName': 'Maksim', 'Initials': 'M', 'LastName': 'Sinitsyn', 'Affiliation': 'Eye Microsurgery Federal State Institution, Cheboksary, Russian Federation.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Verzin', 'Affiliation': 'Eye Microsurgery Federal State Institution, Cheboksary, Russian Federation.'}, {'ForeName': 'Pasquale', 'Initials': 'P', 'LastName': 'De Rosa', 'Affiliation': 'A.O.R.N.A. Cardarelli, Naples, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Calabrò', 'Affiliation': 'A.O.R.N.A. Cardarelli, Naples, Italy.'}, {'ForeName': 'Teresio', 'Initials': 'T', 'LastName': 'Avitabile', 'Affiliation': 'University of Catania, Catania, Italy.'}, {'ForeName': 'Vincenza', 'Initials': 'V', 'LastName': 'Bonfiglio', 'Affiliation': 'University of Catania, Catania, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Fasce', 'Affiliation': 'University Vita-Salute, Milan, Italy.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Barraquer', 'Affiliation': 'Universitat Autònoma de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Josè Lamarca', 'Initials': 'JL', 'LastName': 'Mateu', 'Affiliation': 'Universitat Autònoma de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kohnen', 'Affiliation': 'Goethe-University, Frankfurt, Germany.'}, {'ForeName': 'Marino', 'Initials': 'M', 'LastName': 'Carnovali', 'Affiliation': 'ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy. marino.carnovali@gmail.com.'}, {'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Malyugin', 'Affiliation': 'Eye Microsurgery Federal State Institution, Moscow, Russian Federation.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Eye (London, England)",['10.1038/s41433-020-0869-1']
16,32345410,Response letter to the article by Killackey et al (2019) 'Individual placement and support for vocational recovery in first-episode psychosis: randomised controlled trial'.,,2020,,[],['Individual placement and support'],[],[],"[{'cui': 'C4750554', 'cui_str': 'Individual Placement and Support'}]",[],,0.0642022,,"[{'ForeName': 'B M', 'Initials': 'BM', 'LastName': 'Janaway', 'Affiliation': 'Core Psychiatric Trainee, National Hospital of Neurology and Neurosurgery, UCLH, UK Email: benjamin.janaway@nhs.net.'}, {'ForeName': 'Mukesh', 'Initials': 'M', 'LastName': 'Kripalani', 'Affiliation': 'Consultant Psychiatrist, ADHD centre and PPCS, UK.'}]",The British journal of psychiatry : the journal of mental science,['10.1192/bjp.2020.31']
17,31819201,Hypoxia and exercise interactions on skeletal muscle insulin sensitivity in obese subjects with metabolic syndrome: results of a randomized controlled trial.,"BACKGROUND


Physical activity improves insulin sensitivity in obesity. Hypoxia training is claimed to augment this effect. We tested the hypothesis that normobaric hypoxia training would improve insulin sensitivity in obese patients with metabolic syndrome.
METHODS


In a randomized controlled trial, 23 obese men with metabolic syndrome who were not informed of the FiO 2  conditions underwent a 6-week physical exercise intervention under ambient (n = 11; FiO 2  21%) conditions or hypoxia (n = 12; FiO 2  15%) using a normobaric hypoxic chamber. Three 60-min sessions of interval training were performed each week at 60% of individual V̇O 2max . Assessment of myocellular insulin sensitivity by euglycemic hyperinsulinemic clamp was performed in 21 of these subjects before and after 6 weeks of training. Comprehensive phenotyping also included biopsies of subcutaneous adipose tissues.
RESULTS


The intermittent moderate physical exercise protocol did not substantially change the myocellular insulin sensitivity within 6 weeks under normoxic conditions (ISI Clamp : 0.035 (IQR 0.016-0.075) vs. 0.037 (IQR 0.026-0.056) mg* kg -1  *min -1 /(mU* l -1 ); p = 0.767). In contrast, ISI Clamp  improved during hypoxia training (0.028 (IQR 0.018-0.035) vs. 0.038 (IQR 0.024-0.060) mg * kg -1  *min -1 /(mU *l -1 ); p < 0.05). Between group comparison of ISI Clamp  change revealed a small difference between groups (Cohen's d = 0.26). Within the hypoxic group, improvement of ISI Clamp  during training was associated with individual increase of circulating vascular endothelial growth factor (VEGF) levels (r = 0.678, p = 0.015), even if mean VEGF levels were not modified by any training condition. Atrial natriuretic peptide (ANP) system components were not associated with increased ISI Clamp  during hypoxic training.
CONCLUSIONS


Physical training under hypoxic conditions could partially augment the favorable effects of exercise alone on myocellular insulin sensitivity in obese men with metabolic syndrome. Concomitant changes in VEGF might represent an underlying pathophysiological mechanism.",2020,Between group comparison of ISI Clamp  change revealed a small difference between groups (Cohen's d = 0.26).,"['obese subjects with metabolic syndrome', 'obese men with metabolic syndrome', 'obese patients with metabolic syndrome', '23 obese men with metabolic syndrome who were not informed of the FiO 2  conditions underwent a']","['exercise alone', 'ISI Clamp', 'euglycemic hyperinsulinemic clamp', 'Hypoxia and exercise interactions', 'Hypoxia training', '6-week physical exercise intervention under ambient (n\u2009=\u200911; FiO 2  21%) conditions or hypoxia (n\u2009=\u200912; FiO 2  15%) using a normobaric hypoxic chamber', 'normobaric hypoxia training']","['ISI Clamp', 'circulating vascular endothelial growth factor (VEGF) levels', 'skeletal muscle insulin sensitivity', 'myocellular insulin sensitivity', 'insulin sensitivity', 'mean VEGF levels', 'ISI Clamp  improved during hypoxia training']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0700287', 'cui_str': 'Informing'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0175721', 'cui_str': 'Clamp'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0175721', 'cui_str': 'Clamp'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]",23.0,0.0577071,Between group comparison of ISI Clamp  change revealed a small difference between groups (Cohen's d = 0.26).,"[{'ForeName': 'Knut', 'Initials': 'K', 'LastName': 'Mai', 'Affiliation': 'Experimental and Clinical Research Center (ECRC), a joint collaboration between the Max-Delbrück Center for Molecular Medicine and the Charité Universitätsmedizin, Berlin, Germany, and Helios Clinics Berlin, Berlin, Germany. knut.mai@charite.de.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Klug', 'Affiliation': 'Experimental and Clinical Research Center (ECRC), a joint collaboration between the Max-Delbrück Center for Molecular Medicine and the Charité Universitätsmedizin, Berlin, Germany, and Helios Clinics Berlin, Berlin, Germany.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Rakova', 'Affiliation': 'Experimental and Clinical Research Center (ECRC), a joint collaboration between the Max-Delbrück Center for Molecular Medicine and the Charité Universitätsmedizin, Berlin, Germany, and Helios Clinics Berlin, Berlin, Germany.'}, {'ForeName': 'Sophie K', 'Initials': 'SK', 'LastName': 'Piper', 'Affiliation': 'Berlin Institute of Health (BIH), Anna-Louisa-Karsch Str. 2, 10178, Berlin, Germany.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Mähler', 'Affiliation': 'Experimental and Clinical Research Center (ECRC), a joint collaboration between the Max-Delbrück Center for Molecular Medicine and the Charité Universitätsmedizin, Berlin, Germany, and Helios Clinics Berlin, Berlin, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bobbert', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Medical Clinic of Endocrinology, Diabetes & Nutrition, Berlin, Germany.'}, {'ForeName': 'Jeanette', 'Initials': 'J', 'LastName': 'Schulz-Menger', 'Affiliation': 'Experimental and Clinical Research Center (ECRC), a joint collaboration between the Max-Delbrück Center for Molecular Medicine and the Charité Universitätsmedizin, Berlin, Germany, and Helios Clinics Berlin, Berlin, Germany.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Spranger', 'Affiliation': 'Experimental and Clinical Research Center (ECRC), a joint collaboration between the Max-Delbrück Center for Molecular Medicine and the Charité Universitätsmedizin, Berlin, Germany, and Helios Clinics Berlin, Berlin, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Boschmann', 'Affiliation': 'Experimental and Clinical Research Center (ECRC), a joint collaboration between the Max-Delbrück Center for Molecular Medicine and the Charité Universitätsmedizin, Berlin, Germany, and Helios Clinics Berlin, Berlin, Germany.'}, {'ForeName': 'Friedrich C', 'Initials': 'FC', 'LastName': 'Luft', 'Affiliation': 'Experimental and Clinical Research Center (ECRC), a joint collaboration between the Max-Delbrück Center for Molecular Medicine and the Charité Universitätsmedizin, Berlin, Germany, and Helios Clinics Berlin, Berlin, Germany.'}]",International journal of obesity (2005),['10.1038/s41366-019-0504-z']
18,32346274,HIV Prevention Programming for Older African American Women: The Impact of a Faith-Based and Behavioral Science Partnership on Depressive Symptoms.,"Objective


The current study sought to test the effect of an HIV prevention intervention on depressive symptoms in a sample of older African American women.
Design Setting and Participants


A pretest-posttest randomized control group design was conducted in a mega-church in Los Angeles with a sample of 62 older African American women, aged ≥50 years, 29 of whom were randomly assigned to the experimental condition and 33 to the comparison/control condition.
Measures


A measure of psychological wellbeing (CES-D) was utilized to test the effect of the four-session group intervention vs the one-session informational group intervention on change in depressive symptoms from pretest to posttest. Demographic characteristics included: measures of age in years; relationship and employment statuses (coded 1 for yes, 0 for no); and educational attainment.
Results


Participation in the study was associated with a significant improvement in the women's psychological wellbeing from baseline to time 2; ie, decreased depressive symptoms. This change was greater for women in the four-session experimental group than for those in the one-session comparison group, due in part to a marginally significant interaction between time and experimental conditions.
Conclusions


This study demonstrates the utility of faith-based/behavioral-scientist partnerships in HIV programming. Findings contribute to the evidence on interventions that might reduce depressive symptoms and HIV risk among older African American women.",2020,"This change was greater for women in the four-session experimental group than for those in the one-session comparison group, due in part to a marginally significant interaction between time and experimental conditions.
","['older African American women', '62 older African American women, aged ≥50 years, 29 of whom', 'Older African American Women']","['HIV prevention intervention', 'HIV Prevention Programming', 'faith-based/behavioral-scientist partnerships', 'Faith-Based and Behavioral Science Partnership']","['Depressive Symptoms', ""women's psychological wellbeing"", 'psychological wellbeing (CES-D', 'depressive symptoms and HIV risk', 'depressive symptoms']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0402112', 'cui_str': 'Scientist'}, {'cui': 'C0004940', 'cui_str': 'Behavioral Sciences'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",62.0,0.0279592,"This change was greater for women in the four-session experimental group than for those in the one-session comparison group, due in part to a marginally significant interaction between time and experimental conditions.
","[{'ForeName': 'Megan T', 'Initials': 'MT', 'LastName': 'Ebor', 'Affiliation': 'Center for Culture, Trauma, and Mental Health Disparities, UCLA Semel Institute for Neuroscience and Human Behavior, Los Angeles, CA.'}, {'ForeName': 'Aurora P', 'Initials': 'AP', 'LastName': 'Jackson', 'Affiliation': 'Department of Social Welfare, UCLA Luskin School of Public Affairs, Los Angeles, CA.'}]",Ethnicity & disease,['10.18865/ed.30.2.287']
19,32354298,Effects of Peak Inspiratory Pressure-Guided Setting of Intracuff Pressure for Laryngeal Mask Airway Supreme™ Use during Laparoscopic Cholecystectomy: A Randomized Controlled Trial.,"Purpose:  To determine the effects of peak inspiratory pressure (PIP)-guided intracuff pressure (ICP) modulation of laryngeal mask airway (LMA) Supreme™ during laparoscopic cholecystectomy. Methods:  Totally 120 patients were randomly divided using computer-generated numbers into a control group (n = 60; ICP, 60 cmH 2 O) and a PIP group (n = 60), in which ICP was increased with 5 cmH 2 O each time from PIP level until no air leaks from the oropharynx. PIP, ICP, cuff volume (CV), oropharyngeal leak pressure (OLP) and leak fraction (LF) were recorded before and after pneumoperitoneum establishment. Postoperative pharyngolaryngeal complications (sore throat, dysphagia, pharyngeal hematoma, and dysphonia) were also recorded. Results:  Demographic data were similar in the two groups. The CV and ICP before and after pneumoperitoneum were significantly lower in the PIP group (CV: 15.6 ± 2.3 mL and 21.0 ± 2.6 mL; ICP: 14.3 ± 2.9 cmH 2 O and 20.5 ± 3.4 cmH 2 O) than in the control group (CV: 33.0 ± 2.8 mL and 32.8 ± 1.9 mL; ICP: 60.0 ± 0.1 cmH 2 O and 60.0 ± 0.1 cmH 2 O) ( P  < 0.05). Although OLP was lower in the PIP group ( P  < 0.05), the LF was similar in the two groups ( P  > 0.05). There were fewer postoperative pharyngolaryngeal complications in the PIP group ( P  < 0.05). Conclusions:  Compared with a fixed ICP of 60 cmH 2 O, PIP-guided ICP modulation during LMA Supreme™ use provided effective airway sealing at a lower CV and ICP, and produced fewer postoperative pharyngolaryngeal complications in patients undergoing laparoscopic cholecystectomy.",2020,There were fewer postoperative pharyngolaryngeal complications in the PIP group ( P  < 0.05).,"['Laparoscopic Cholecystectomy', 'Totally 120 patients', 'patients undergoing laparoscopic cholecystectomy']","['laparoscopic cholecystectomy', 'peak inspiratory pressure (PIP)-guided intracuff pressure (ICP) modulation of laryngeal mask airway (LMA', 'Peak Inspiratory Pressure-Guided Setting of Intracuff Pressure for Laryngeal Mask Airway Supreme']","['postoperative pharyngolaryngeal complications', 'CV and ICP', 'OLP', 'Postoperative pharyngolaryngeal complications (sore throat, dysphagia, pharyngeal hematoma, and dysphonia', 'LF', 'PIP, ICP, cuff volume (CV), oropharyngeal leak pressure (OLP) and leak fraction (LF']","[{'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0232021', 'cui_str': 'Peak inspiratory pressure'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0162645', 'cui_str': 'Laryngeal mask'}, {'cui': 'C3282376', 'cui_str': 'Supreme'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0031350', 'cui_str': 'Pharyngitis'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C2242660', 'cui_str': 'Pharyngeal haematoma'}, {'cui': 'C0019825', 'cui_str': 'Hoarse'}, {'cui': 'C0441107', 'cui_str': 'Device cuff'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C0332234', 'cui_str': 'Leaking'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}]",120.0,0.046459,There were fewer postoperative pharyngolaryngeal complications in the PIP group ( P  < 0.05).,"[{'ForeName': 'Mao-Hua', 'Initials': 'MH', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, The Affiliated Hospital of Yangzhou University, Yangzhou University, Yangzhou, China.'}, {'ForeName': 'Dong-Sheng', 'Initials': 'DS', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, The Affiliated Hospital of Yangzhou University, Yangzhou University, Yangzhou, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhou', 'Affiliation': 'Department of Anesthesiology, The Affiliated Hospital of Yangzhou University, Yangzhou University, Yangzhou, China.'}, {'ForeName': 'Shun-Ping', 'Initials': 'SP', 'LastName': 'Tian', 'Affiliation': 'School of Medicine, Yangzhou University, Yangzhou, China.'}, {'ForeName': 'Tian-Qi', 'Initials': 'TQ', 'LastName': 'Zhou', 'Affiliation': 'Preventive Health Care Office, The Affiliated Hospital of Yangzhou University, Yangzhou University, Yangzhou, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Sui', 'Affiliation': 'Department of Anesthesiology, The Affiliated Hospital of Yangzhou University, Yangzhou University, Yangzhou, China.'}, {'ForeName': 'Zhuan', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, The Affiliated Hospital of Yangzhou University, Yangzhou University, Yangzhou, China.'}]",Journal of investigative surgery : the official journal of the Academy of Surgical Research,['10.1080/08941939.2020.1761487']
20,32356631,[Effectiveness of various methods of cryotherapy in patients with osteoarthritis].,"Aim of this study - the comparative effectiveness of cryotherapy (CT) with ice 0 °C, CT with ice 0 °C + SMC (cryo-SMC), air cryotherapy (ACT) -30 °C, hyperbaric gas cryotherapy (HC) CO2 -78 °C.
MATERIAL AND METHODS


We examined 150 patients with II - IV stage osteoarthritis of the knee and hip joints, movement pain of more than 40 mm on a VAS and Leken index more than 9. 120 of these patients received a course of CT of various temperatures and cryo-SMC for 2 weeks: 1st group ( n =30) - CT of ice 0 °C; 2nd group ( n =30) - cryo-SMC; 3rd group ( n =30) - ACT; 4th group ( n =30) - HC. The 5th group (control) included patients ( n =30) who received only non-steroidal anti-inflammatory drugs (NSAIDs). We assessed dynamics of rest and movement pain according to VAS, the WOMAC index, the effectiveness according to the OMERACT-OARSI criterion and the need for NSAIDs. Effectiveness of treatment was evaluated by the patient and the doctor.
RESULTS


OMERACT-OARSI analysis demonstrated a high percentage of CT response. A statistically significant decrease in rest and movement pain intensity was registered in all patients of the groups: ice 0 °C, cryo-SMC, ACT, HC and control groups. The pain decreased by 82-83% in the groups 1-4, and by 70% in the control group. There were no differences in the effectiveness of treatment between groups 1, 3, and 4 and the cryo-SMC group; effectiveness of treatment was statistically significant ( p <0.01) between groups 1-4 and the control group. A statistically significant decrease in the total WOMAC index, as well as in «pain» and «stiffness» VAS subscales ( p <0.01) in the absence of intergroup differences in the 1st, 3rd, 4th groups and the cryo-SMC ( p >0.05) group and a statistically significant difference between the 1st-4th groups and the control group ( p <0.01). According to the «function» subscale of the WOMAC index, a statistically significant difference between all groups was not found ( p >0.05).
CONCLUSION


Results of this study according to the OMERACT-OARSI effectiveness evaluation criteria indicate the comparability of CT as a treatment method with NSAID therapy in terms of the effect on improving the patient's functional capabilities and greater CT efficiency in relieving pain and stiffness in the joints.",2020,"According to the «function» subscale of the WOMAC index, a statistically significant difference between all groups was not found ( p >0.05).
","['The 5th group (control) included patients ( n =30) who received only non-steroidal anti-inflammatory drugs (NSAIDs', 'patients with osteoarthritis', '150 patients with II - IV stage osteoarthritis of the knee and hip joints, movement pain of more than 40 mm on a VAS and Leken index more than 9']","['cryotherapy (CT) with ice 0', '°C + SMC (cryo-SMC), air cryotherapy (ACT', 'cryotherapy', 'HC) CO2', 'CT of ice 0', 'hyperbaric gas cryotherapy', 'CT of various temperatures and cryo-SMC']","['total WOMAC index', 'CT response', 'rest and movement pain intensity', 'pain', '«pain» and «stiffness» VAS subscales']","[{'cui': 'C0205439', 'cui_str': 'Fifth'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0019558', 'cui_str': 'Hip joint structure'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0450402', 'cui_str': '40mm'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]","[{'cui': 'C4551716', 'cui_str': 'Cryotherapy'}, {'cui': 'C0020746', 'cui_str': 'Ice'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",150.0,0.0223419,"According to the «function» subscale of the WOMAC index, a statistically significant difference between all groups was not found ( p >0.05).
","[{'ForeName': 'T A', 'Initials': 'TA', 'LastName': 'Dashina', 'Affiliation': 'Central Production and Commercial Department for the Service of the Diplomatic Corps under the Ministry of Foreign Affairs of the Russian Federation (Medical Center), Moscow, Russia.'}, {'ForeName': 'L G', 'Initials': 'LG', 'LastName': 'Agasarov', 'Affiliation': 'I.M. Sechenov First Moscow State Medical University of the Ministry of Health of Russia (Sechenov University), Moscow, Russia.'}]","Voprosy kurortologii, fizioterapii, i lechebnoi fizicheskoi kultury",['10.17116/kurort20209702120']
21,32359046,Does Unit-Dose Packaging Influence Understanding of Serving Size Information for Cannabis Edibles?,"OBJECTIVE


Edible cannabis products have increased in popularity, particularly in jurisdictions that have legalized nonmedical cannabis. Rates of adverse events from cannabis edibles have also increased, in part because of difficulties identifying and titrating tetrahydrocannabinol (THC) levels. The current study tested whether packaging cannabis in separate units enhances consumer understanding of serving sizes.
METHOD


An experimental task was conducted as part of the 2018 International Cannabis Policy Study online survey. Participants were recruited from the Nielsen Global Insights Consumer Panel. A total of 26,894 participants (61.5% female) ages 16-65 years from Canada and the United States were randomly assigned to view a cannabis brownie packaged according to one of three conditions: (a) multiserving edible (""control condition""), (b) single-serving edible, and (c) single-serving edible packaged separately (""unit-dose packaging""). Participants were asked to identify a standard serving based on information on the product label. Logistic regression was used to test the influence of packaging condition on the likelihood of a correct response, adjusting for key covariates.
RESULTS


Compared with the multiserving edible control (50.6%), participants were significantly more likely to correctly identify the serving size in the single-serving edible condition (55.3%; adjusted odds ratio = 1.22, CI [1.15, 1.29], p < .001) and the unit-dose packaging condition (54.3%; adjusted odds ratio = 1.17, CI [1.10, 1.24], p < .001).
CONCLUSIONS


Packaging in which each product unit contained one dose of THC enhanced consumers' ability to identify how much of a product constitutes a standard serving or dose. Packaging products as individual doses eliminates the need for mental math and could reduce the risk of accidental overconsumption of cannabis.",2020,"Compared with the multiserving edible control (50.6%), participants were significantly more likely to correctly identify the serving size in the single-serving edible condition (55.3%; adjusted odds ratio = 1.22, CI [1.15, 1.29], p < .001) and the unit-dose packaging condition (54.3%; adjusted odds ratio = 1.17, CI [1.10, 1.24], p < .001).
","['26,894 participants (61.5% female) ages 16-65 years from Canada and the United States', 'An experimental task was conducted as part of the 2018 International Cannabis Policy Study online survey', 'Participants were recruited from the Nielsen Global Insights Consumer Panel']","['cannabis brownie packaged according to one of three conditions: (a) multiserving edible (""control condition""), (b) single-serving edible, and (c) single-serving edible packaged separately (""unit-dose packaging']",[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0242456', 'cui_str': 'Policy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0233820', 'cui_str': 'Insight'}, {'cui': 'C0441833', 'cui_str': 'Groups'}]","[{'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]",[],26894.0,0.0568791,"Compared with the multiserving edible control (50.6%), participants were significantly more likely to correctly identify the serving size in the single-serving edible condition (55.3%; adjusted odds ratio = 1.22, CI [1.15, 1.29], p < .001) and the unit-dose packaging condition (54.3%; adjusted odds ratio = 1.17, CI [1.10, 1.24], p < .001).
","[{'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Goodman', 'Affiliation': 'School of Public Health & Health Systems, University of Waterloo, Waterloo, Ontario, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hammond', 'Affiliation': 'School of Public Health & Health Systems, University of Waterloo, Waterloo, Ontario, Canada.'}]",Journal of studies on alcohol and drugs,[]
22,32357445,Dietary Intervention through Flipped Learning as a Techno Pedagogy for the Promotion of Healthy Eating in Secondary Education.,"Technological progress in the educational field has led to the application of active and innovative teaching methods, such as flipped learning, including in the field of dietary education. This is considered a mixed formative approach that combines face-to-face and outside the classroom education. The objective of this research was to analyze the effectiveness of flipped learning methodology on a traditional training practice in dietary training, both in the sixth grade of primary education and in the fourth level of secondary education. A quasi-experimental design was adopted with two experimental groups, two control groups and only posttest. The final sample was composed of 115 students divided into four groups, two of each educational stage mentioned. A didactic unit consisting of six sessions in all groups was applied. Two different training methodologies were followed according to the nature of the group (control-traditional; experimental-flipped learning). The results reveal that flipped learning is effective both in primary education and in secondary education, being more influential in student development in this last stage. It is concluded that the flipped learning approach has meant an improvement of the academic indicators evaluated after a diet education program.",2020,It is concluded that the flipped learning approach has meant an improvement of the academic indicators evaluated after a diet education program.,"['115 students divided into four groups, two of each educational stage mentioned', 'Healthy Eating in Secondary Education']",['Dietary Intervention through Flipped Learning'],[],"[{'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0540654', 'cui_str': 'Casper Protein'}, {'cui': 'C0013621', 'cui_str': 'Education'}]",[],115.0,0.0136494,It is concluded that the flipped learning approach has meant an improvement of the academic indicators evaluated after a diet education program.,"[{'ForeName': 'Juan Antonio', 'Initials': 'JA', 'LastName': 'López Núñez', 'Affiliation': 'Department of Didactics and School Organization, University of Granada, 18071 Granada, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'López-Belmonte', 'Affiliation': 'Department of Didactics and School Organization, University of Granada, 18071 Granada, Spain.'}, {'ForeName': 'Antonio-José', 'Initials': 'AJ', 'LastName': 'Moreno-Guerrero', 'Affiliation': 'Department of Didactics and School Organization, University of Granada, 18071 Granada, Spain.'}, {'ForeName': 'José Antonio', 'Initials': 'JA', 'LastName': 'Marín-Marín', 'Affiliation': 'Department of Didactics and School Organization, University of Granada, 18071 Granada, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17093007']
23,32359153,Substituting Lean Beef for Carbohydrate in a Healthy Dietary Pattern Does Not Adversely Affect the Cardiometabolic Risk Factor Profile in Men and Women at Risk for Type 2 Diabetes.,"BACKGROUND


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


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


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


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


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


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


USDA-LB and USDA-CON did not differ significantly in effects on whole-body insulin sensitivity and other indicators of carbohydrate metabolism, lipoprotein lipids, apoA-I and apoB, hs-CRP, and blood pressures.","[{'ForeName': 'Kevin C', 'Initials': 'KC', 'LastName': 'Maki', 'Affiliation': 'Midwest Biomedical Research Center for Metabolic and Cardiovascular Health, Addison, IL, USA.'}, {'ForeName': 'Meredith L', 'Initials': 'ML', 'LastName': 'Wilcox', 'Affiliation': 'Midwest Biomedical Research Center for Metabolic and Cardiovascular Health, Addison, IL, USA.'}, {'ForeName': 'Mary R', 'Initials': 'MR', 'LastName': 'Dicklin', 'Affiliation': 'Midwest Biomedical Research Center for Metabolic and Cardiovascular Health, Addison, IL, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Buggia', 'Affiliation': 'Midwest Biomedical Research Center for Metabolic and Cardiovascular Health, Addison, IL, USA.'}, {'ForeName': 'Orsolya M', 'Initials': 'OM', 'LastName': 'Palacios', 'Affiliation': 'Midwest Biomedical Research Center for Metabolic and Cardiovascular Health, Addison, IL, USA.'}, {'ForeName': 'Cathleen E', 'Initials': 'CE', 'LastName': 'Maki', 'Affiliation': 'Midwest Biomedical Research Center for Metabolic and Cardiovascular Health, Addison, IL, USA.'}, {'ForeName': 'Melvyn', 'Initials': 'M', 'LastName': 'Kramer', 'Affiliation': 'Midwest Biomedical Research Center for Metabolic and Cardiovascular Health, Addison, IL, USA.'}]",The Journal of nutrition,['10.1093/jn/nxaa116']
24,32359506,"Autologous haematopoietic stem-cell transplantation versus bortezomib-melphalan-prednisone, with or without bortezomib-lenalidomide-dexamethasone consolidation therapy, and lenalidomide maintenance for newly diagnosed multiple myeloma (EMN02/HO95): a multicentre, randomised, open-label, phase 3 study.","BACKGROUND


The emergence of highly active novel agents has led some to question the role of autologous haematopoietic stem-cell transplantation (HSCT) and subsequent consolidation therapy in newly diagnosed multiple myeloma. We therefore compared autologous HSCT with bortezomib-melphalan-prednisone (VMP) as intensification therapy, and bortezomib-lenalidomide-dexamethasone (VRD) consolidation therapy with no consolidation.
METHODS


In this randomised, open-label, phase 3 study we recruited previously untreated patients with multiple myeloma at 172 academic and community practice centres of the European Myeloma Network. Eligible patients were aged 18-65 years, had symptomatic multiple myeloma stage 1-3 according to the International Staging System (ISS), measurable disease (serum M protein >10 g/L or urine M protein >200 mg in 24 h or abnormal free light chain [FLC] ratio with involved FLC >100 mg/L, or proven plasmacytoma by biopsy), and WHO performance status grade 0-2 (grade 3 was allowed if secondary to myeloma). Patients were first randomly assigned (1:1) to receive either four 42-day cycles of bortezomib (1·3 mg/m 2  administered intravenously or subcutaneously on days 1, 4, 8, 11, 22, 25, 29, and 32) combined with melphalan (9 mg/m 2  administered orally on days 1-4) and prednisone (60 mg/m 2  administered orally on days 1-4) or autologous HSCT after high-dose melphalan (200 mg/m 2 ), stratified by site and ISS disease stage. In centres with a double HSCT policy, the first randomisation (1:1:1) was to VMP or single or double HSCT. Afterwards, a second randomisation assigned patients to receive two 28-day cycles of consolidation therapy with bortezomib (1·3 mg/m 2  either intravenously or subcutaneously on days 1, 4, 8, and 11), lenalidomide (25 mg orally on days 1-21), and dexamethasone (20 mg orally on days 1, 2, 4, 5, 8, 9, 11, and 12) or no consolidation; both groups received lenalidomide maintenance therapy (10 mg orally on days 1-21 of a 28-day cycle). The primary outcomes were progression-free survival from the first and second randomisations, analysed in the intention-to-treat population, which included all patients who underwent each randomisation. All patients who received at least one dose of study drugs were included in the safety analyses. This study is registered with the EU Clinical Trials Register (EudraCT 2009-017903-28) and ClinicalTrials.gov (NCT01208766), and has completed recruitment.
FINDINGS


Between Feb 25, 2011, and April 3, 2014, 1503 patients were enrolled. 1197 patients were eligible for the first randomisation, of whom 702 were assigned to autologous HSCT and 495 to VMP; 877 patients who were eligible for the first randomisation underwent the second randomisation to VRD consolidation (n=449) or no consolidation (n=428). The data cutoff date for the current analysis was Nov 26, 2018. At a median follow-up of 60·3 months (IQR 52·2-67·6), median progression-free survival was significantly improved with autologous HSCT compared with VMP (56·7 months [95% CI 49·3-64·5] vs 41·9 months [37·5-46·9]; hazard ratio [HR] 0·73, 0·62-0·85; p=0·0001). For the second randomisation, the number of events of progression or death at data cutoff was lower than that preplanned for the final analysis; therefore, the results from the second protocol-specified interim analysis, when 66% of events were reached, are reported (data cutoff Jan 18, 2018). At a median follow-up of 42·1 months (IQR 32·3-49·2), consolidation therapy with VRD significantly improved median progression-free survival compared with no consolidation (58·9 months [54·0-not estimable] vs 45·5 months [39·5-58·4]; HR 0·77, 0·63-0·95; p=0·014). The most common grade ≥3 adverse events in the autologous HSCT group compared to the VMP group included neutropenia (513 [79%] of 652 patients vs 137 [29%] of 472 patients), thrombocytopenia (541 [83%] vs 74 [16%]), gastrointestinal disorders (80 [12%] vs 25 [5%]), and infections (192 [30%] vs 18 [4%]). 239 (34%) of 702 patients in the autologous HSCT group and 135 (27%) of 495 in the VMP group had at least one serious adverse event. Infection was the most common serious adverse event in each of the treatment groups (206 [56%] of 368 and 70 [37%] of 189). 38 (12%) of 311 deaths from first randomisation were likely to be treatment related: 26 (68%) in the autologous HSCT group and 12 (32%) in the VMP group, most frequently due to infections (eight [21%]), cardiac events (six [16%]), and second primary malignancies (20 [53%]).
INTERPRETATION


This study supports the use of autologous HSCT as intensification therapy and the use of consolidation therapy in patients with newly diagnosed multiple myeloma, even in the era of novel agents. The role of high-dose chemotherapy needs to be reassessed in future studies, in particular in patients with undetectable minimal residual disease after four-drug induction regimens including a monoclonal antiboby combined with an immunomodulatory agent and a proteasome inhibitor plus dexamethasone.
FUNDING


Janssen and Celgene.",2020,Infection was the most common serious adverse event in each of the treatment groups (206 [56%] of 368 and 70 [37%] of 189).,"['untreated patients with multiple myeloma at 172 academic and community practice centres of the European Myeloma Network', 'Eligible patients were aged 18-65 years, had symptomatic multiple myeloma stage 1-3 according to the International Staging System (ISS), measurable disease (serum M protein', 'patients with newly diagnosed multiple myeloma', '1197 patients were eligible for the first randomisation, of whom 702 were assigned to autologous HSCT and 495 to VMP; 877 patients who were eligible for the first randomisation underwent the second randomisation to VRD consolidation (n=449) or no consolidation (n=428', '1503 patients were enrolled', 'patients with undetectable minimal residual disease after four-drug induction regimens including a monoclonal antiboby combined with an immunomodulatory agent and a proteasome inhibitor plus', 'All patients who received at least one dose of study drugs were included in the safety analyses', 'Between Feb 25, 2011, and April 3, 2014', 'newly diagnosed multiple myeloma (EMN02/HO95']","['VMP or single or double HSCT', 'prednisone', 'autologous HSCT after high-dose melphalan', 'lenalidomide', 'dexamethasone', 'bortezomib-lenalidomide-dexamethasone (VRD) consolidation therapy', 'melphalan', 'consolidation therapy with bortezomib', 'lenalidomide maintenance therapy', 'autologous HSCT', 'VMP', 'bortezomib', 'L or urine M protein', 'Autologous haematopoietic stem-cell transplantation versus bortezomib-melphalan-prednisone, with or without bortezomib-lenalidomide-dexamethasone consolidation therapy', 'autologous haematopoietic stem-cell transplantation (HSCT', 'autologous HSCT with bortezomib-melphalan-prednisone (VMP']","['median progression-free survival', 'neutropenia', 'progression-free survival', 'number of events of progression or death at data cutoff', 'gastrointestinal disorders', 'cardiac events', 'serious adverse event', 'thrombocytopenia']","[{'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C4517601', 'cui_str': '172'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0449394', 'cui_str': 'Staging system'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0065450', 'cui_str': 'M-proteins (Myeloma)'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0018956', 'cui_str': 'Hematopoietic stem cell'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0521530', 'cui_str': 'Lung consolidation'}, {'cui': 'C0242596', 'cui_str': 'Minimal residual disease'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C1443643', 'cui_str': 'Proteasome inhibitor'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0018956', 'cui_str': 'Hematopoietic stem cell'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0025241', 'cui_str': 'Melphalan'}, {'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C1176309', 'cui_str': 'bortezomib'}, {'cui': 'C0521530', 'cui_str': 'Lung consolidation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0065450', 'cui_str': 'M-proteins (Myeloma)'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0017178', 'cui_str': 'Disorder of gastrointestinal tract'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}]",1503.0,0.203417,Infection was the most common serious adverse event in each of the treatment groups (206 [56%] of 368 and 70 [37%] of 189).,"[{'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Cavo', 'Affiliation': 'Seràgnoli Institute of Hematology, Department of Experimental, Diagnostic and Specialty Medicine, Bologna University School of Medicine, S Orsola Malpighi Hospital, Bologna, Italy. Electronic address: michele.cavo@unibo.it.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Gay', 'Affiliation': 'Myeloma Unit, Division of Hematology, University of Torino, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Turin, Italy.'}, {'ForeName': 'Meral', 'Initials': 'M', 'LastName': 'Beksac', 'Affiliation': 'Department of Hematology, Ankara University School of Medicine, Ankara, Turkey.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Pantani', 'Affiliation': 'Seràgnoli Institute of Hematology, Department of Experimental, Diagnostic and Specialty Medicine, Bologna University School of Medicine, S Orsola Malpighi Hospital, Bologna, Italy.'}, {'ForeName': 'Maria Teresa', 'Initials': 'MT', 'LastName': 'Petrucci', 'Affiliation': 'Hematology, Department of Translational and Precision Medicine, Azienda Ospedaliera Policlinico Umberto I, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Meletios A', 'Initials': 'MA', 'LastName': 'Dimopoulos', 'Affiliation': 'Department of Clinical Therapeutics, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Dozza', 'Affiliation': 'Seràgnoli Institute of Hematology, Department of Experimental, Diagnostic and Specialty Medicine, Bologna University School of Medicine, S Orsola Malpighi Hospital, Bologna, Italy.'}, {'ForeName': 'Bronno', 'Initials': 'B', 'LastName': 'van der Holt', 'Affiliation': 'Department of Trials and Statistics-HOVON Data Centre, Erasmus MC Cancer Institute, Rotterdam, Netherlands.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Zweegman', 'Affiliation': 'Department of Hematology, VU University Medical Center, Cancer Center Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Oliva', 'Affiliation': 'Myeloma Unit, Division of Hematology, University of Torino, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Turin, Italy.'}, {'ForeName': 'Vincent H J', 'Initials': 'VHJ', 'LastName': 'van der Velden', 'Affiliation': 'Department of Immunology, Erasmus MC, Rotterdam, Netherlands.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Zamagni', 'Affiliation': 'Seràgnoli Institute of Hematology, Department of Experimental, Diagnostic and Specialty Medicine, Bologna University School of Medicine, S Orsola Malpighi Hospital, Bologna, Italy.'}, {'ForeName': 'Giuseppe A', 'Initials': 'GA', 'LastName': 'Palumbo', 'Affiliation': 'Dipartimento di Science Mediche Chirurgiche e Tecnologie Avanzate ""GF Ingrassia"", Università degli Studi di Catania, Catania, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Patriarca', 'Affiliation': 'Clinical Hematology and Bone Marrow Transplant Centre, S Maria della Misericordia University Hospital, DAME, University of Udine, Udine, Italy.'}, {'ForeName': 'Vittorio', 'Initials': 'V', 'LastName': 'Montefusco', 'Affiliation': 'Hematology Department, Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Galli', 'Affiliation': 'Hematology and Bone Marrow Transplant Unit, ASST-Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Maisnar', 'Affiliation': '4th Department of Internal Medicine-Hematology, Charles University Hospital and Faculty of Medicine, Hradec Kralove, Czech Republic.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Gamberi', 'Affiliation': 'Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Hansson', 'Affiliation': 'Skane University Hospital, Lund, Sweden.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Belotti', 'Affiliation': 'SC Ematologia e Dipartimento di Oncologia Clinica, AO Spedali Civili, Brescia, Italy.'}, {'ForeName': 'Ludek', 'Initials': 'L', 'LastName': 'Pour', 'Affiliation': 'University Hospital Brno, Brno, Czech Republic.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Ypma', 'Affiliation': 'Department of Hematology, Haga Hospital, The Hague, Netherlands.'}, {'ForeName': 'Mariella', 'Initials': 'M', 'LastName': 'Grasso', 'Affiliation': 'SC Ematologia, Azienda Ospedaliera S Croce-Carle, Cuneo, Italy.'}, {'ForeName': 'Alexsandra', 'Initials': 'A', 'LastName': 'Croockewit', 'Affiliation': 'Department of Hematology, Radboud University Medical Centre, Nijmegen, Netherlands.'}, {'ForeName': 'Stelvio', 'Initials': 'S', 'LastName': 'Ballanti', 'Affiliation': 'Reparto di Ematologia con TMO, Ospedale Santa Maria della Misericordia, Perugia, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Offidani', 'Affiliation': 'Clinica di Ematologia, AOU Ospedali Riuniti di Ancona, Ancona, Italy.'}, {'ForeName': 'Iolanda D', 'Initials': 'ID', 'LastName': 'Vincelli', 'Affiliation': 'Division of Haematology, Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli, Reggio Calabria, Italy.'}, {'ForeName': 'Renato', 'Initials': 'R', 'LastName': 'Zambello', 'Affiliation': 'Hematology, Azienda Ospedaliera di Padova, Padua, Italy.'}, {'ForeName': 'Anna Marina', 'Initials': 'AM', 'LastName': 'Liberati', 'Affiliation': 'Faculty of Medicine, Università degli Studi di Perugia, Perugia, Italy.'}, {'ForeName': 'Niels Frost', 'Initials': 'NF', 'LastName': 'Andersen', 'Affiliation': 'Department of Haematology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Annemiek', 'Initials': 'A', 'LastName': 'Broijl', 'Affiliation': 'Department of Hematology, Erasmus MC Cancer Institute, Rotterdam, Netherlands.'}, {'ForeName': 'Rossella', 'Initials': 'R', 'LastName': 'Troia', 'Affiliation': 'Myeloma Unit, Division of Hematology, University of Torino, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Turin, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Pascarella', 'Affiliation': ""Hematology Unit, Ospedale dell'Angelo, Mestre, Venice, Italy.""}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Benevolo', 'Affiliation': 'Myeloma Unit, Division of Hematology, University of Torino, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Turin, Italy.'}, {'ForeName': 'Mark-David', 'Initials': 'MD', 'LastName': 'Levin', 'Affiliation': 'Department of Internal Medicine, Albert Schweitzer Hospital, Dordrecht, Netherlands.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Bos', 'Affiliation': 'Department of Haematology, Maastricht University Medical Center, Maastricht, Netherlands.'}, {'ForeName': 'Heinz', 'Initials': 'H', 'LastName': 'Ludwig', 'Affiliation': 'Wilhelminen Cancer Research Institute, Wilhelminenspital, Vienna, Austria.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Aquino', 'Affiliation': 'Ematologia e Centro Trapianti, IRCCS Ospedale Policlinico San Martino, Genoa, Italy.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Morelli', 'Affiliation': 'Clinical Hematology, Department of Hematology, Transfusion Medicine and Biotechnology, ""Spirito Santo"" Civic Hospital, Pescara, Italy.'}, {'ForeName': 'Ka Lung', 'Initials': 'KL', 'LastName': 'Wu', 'Affiliation': 'Department of Hematology, ZNA Stuivenberg, Antwerp, Belgium.'}, {'ForeName': 'Rinske', 'Initials': 'R', 'LastName': 'Boersma', 'Affiliation': 'Department of Internal Medicine, Amphia Hospital Breda, Breda, Netherlands.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Hajek', 'Affiliation': 'Department of Hematooncology, University Hospital Ostrava and University of Ostrava, Ostrava, Czech Republic.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Durian', 'Affiliation': 'University Hospital and Faculty of Medicine, Hradec Kralove, Czech Republic.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'von dem Borne', 'Affiliation': 'Department of Hematology, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Tommaso', 'Initials': 'T', 'LastName': 'Caravita di Toritto', 'Affiliation': 'UOSD Ematologia ASL Roma 1, Rome, Italy.'}, {'ForeName': 'Thilo', 'Initials': 'T', 'LastName': 'Zander', 'Affiliation': 'Department Oncology/Hematology, Kantonsspital, Lucerne, Switzerland.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Driessen', 'Affiliation': 'Department Oncology/Hematology, Kantonsspital, St Gallen, Switzerland.'}, {'ForeName': 'Giorgina', 'Initials': 'G', 'LastName': 'Specchia', 'Affiliation': 'Hematology, University Aldo Moro, Bari, Italy.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Waage', 'Affiliation': 'Department of Hematology, St Olavs Hospital and Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Gimsing', 'Affiliation': 'Department of Haematology, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Ulf-Henrik', 'Initials': 'UH', 'LastName': 'Mellqvist', 'Affiliation': 'Department of Medicine, Section of Hematology and Coagulation, South Elvsborg Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Marinus', 'Initials': 'M', 'LastName': 'van Marwijk Kooy', 'Affiliation': 'Isala Kliniek, Zwolle, Netherlands.'}, {'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'Minnema', 'Affiliation': 'Department of Hematology, UMC Utrecht, University Utrecht, Utrecht, Netherlands.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Mandigers', 'Affiliation': 'Department of Hematology, Canisius-Wilhelmina Hospital, Nijmegen, Netherlands.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Cafro', 'Affiliation': 'Department of Hematology, ASST Grande Ospedale Metropolitano, Niguarda, Milan, Italy.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Palmas', 'Affiliation': 'Haematology, Ospedale San Francesco, Nuoro, Italy.'}, {'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Carvalho', 'Affiliation': 'Instituto Português de Oncologia de Lisboa Francisco Gentil, IPOLFG, Lisbon, Portugal.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Spencer', 'Affiliation': 'Department of Haematology, Alfred Hospital-Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Boccadoro', 'Affiliation': 'Myeloma Unit, Division of Hematology, University of Torino, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Turin, Italy.'}, {'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'Sonneveld', 'Affiliation': 'Department of Hematology, Erasmus MC Cancer Institute, Rotterdam, Netherlands.'}]",The Lancet. Haematology,['10.1016/S2352-3026(20)30099-5']
25,32360596,What factors modify the effect of monthly bolus dose vitamin D supplementation on 25-hydroxyvitamin D concentrations?,"The increasing use of vitamin D supplements has stimulated interest in identifying factors that may modify the effect of supplementation on circulating 25-hydroxyvitamin D (25(OH)D) concentrations. Such information is of potential interest to researchers, clinicians and patients when deciding on bolus dose of vitamin D supplementation. We carried out a large randomized controlled trial of 5110 adults aged 50-84 years, of European/Other (84%), Polynesian (11%) and Asian (5%) ethnicity, to whom we gave a standard dose of vitamin D 3  supplements (200,000 IU initially, then 100,000 IU monthly) which was taken with high adherence. All participants provided a baseline blood sample, and follow-up blood samples were collected at 6 months and annually for 3 years in a random sample of 441 participants, and also at 2 years in 413 participants enrolled in a bone density sub-study. Serum 25(OH)D was measured by LC/MSMS. Mixed model analyses were carried out on all 854 participants providing follow-up blood samples in multivariable models that included age, sex, ethnicity, body mass index (kg/m 2 ), tobacco smoking, alcohol intake, physical activity, sun exposure, season, medical prescription of high-dose vitamin D 3  (Cal.D.Forte tablets), asthma/COPD and the study treatment (vitamin D or placebo). The adjusted mean difference in 25(OH)D in the follow-up points between vitamin D supplementation and placebo groups was inversely related (all p for interaction <0.05) to baseline 25(OH)D, BMI, and hours of sun exposure, and higher in females, elders, and those with high frequency of alcohol, medical prescription of vitamin D, and asthma/COPD. The mean difference was not significantly related to ethnicity (p = 0.12), tobacco (p = 0.34), and vigorous activity (p = 0.33). In summary, these data show that vitamin D status, BMI, sun exposure hours, sex and asthma/COPD modify the 25(OH)D response to vitamin D supplementation. By contrast, ethnicity, tobacco smoking, and vigorous activity do not.",2020,"The mean difference was not significantly related to ethnicity (p = 0.12), tobacco (p = 0.34), and vigorous activity (p = 0.33).","['5,110 adults aged 50-84 years, of European/Other (84%), Polynesian (11%) and Asian (5%) ethnicity', 'All participants provided a baseline blood sample, and follow-up blood samples were collected at 6 months and annually for 3 years in a random sample of 441 participants, and also at 2 years in 413 participants enrolled in a bone density sub-study', '854 participants providing follow-up blood samples in multivariable models that included age, sex, ethnicity, body mass index (kg/m 2 ), tobacco smoking, alcohol intake, physical activity, sun exposure, season, medical prescription of high-dose vitamin D 3  (Cal']","['vitamin D supplements', 'vitamin D 3  supplements', 'vitamin D or placebo', 'vitamin D supplementation', 'placebo']","['vigorous activity', 'circulating 25-hydroxyvitamin D (25(OH)D) concentrations', 'baseline 25(OH)D, BMI, and hours of sun exposure', 'Serum 25(OH)D', '25-hydroxyvitamin D concentrations', 'vitamin D status, BMI, sun exposure hours, sex and asthma/COPD']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0240790', 'cui_str': 'Polynesians'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0453996', 'cui_str': 'Tobacco smoking behavior - finding'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0038817', 'cui_str': 'Sunlight'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0439259', 'cui_str': 'kcal'}]","[{'cui': 'C0420176', 'cui_str': 'Vitamin D supplement therapy'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0038817', 'cui_str': 'Sunlight'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}]",5110.0,0.281124,"The mean difference was not significantly related to ethnicity (p = 0.12), tobacco (p = 0.34), and vigorous activity (p = 0.33).","[{'ForeName': 'Zhenqiang', 'Initials': 'Z', 'LastName': 'Wu', 'Affiliation': 'School of Population Health, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Camargo', 'Affiliation': 'Department of Emergency Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Ian R', 'Initials': 'IR', 'LastName': 'Reid', 'Affiliation': 'Department of Medicine, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Beros', 'Affiliation': 'School of Population Health, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Sluyter', 'Affiliation': 'School of Population Health, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Waayer', 'Affiliation': 'School of Population Health, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Carlene M M', 'Initials': 'CMM', 'LastName': 'Lawes', 'Affiliation': 'School of Population Health, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Les', 'Initials': 'L', 'LastName': 'Toop', 'Affiliation': 'Department of Public Health & General Practice, The University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'Kay-Tee', 'Initials': 'KT', 'LastName': 'Khaw', 'Affiliation': 'Department of Public Health, University of Cambridge, Cambridge, England, United Kingdom.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Scragg', 'Affiliation': 'School of Population Health, The University of Auckland, Auckland, New Zealand. Electronic address: r.scragg@auckland.ac.nz.'}]",The Journal of steroid biochemistry and molecular biology,['10.1016/j.jsbmb.2020.105687']
26,32375741,Integrating pediatric TB services into child healthcare services in Africa: study protocol for the INPUT cluster-randomized stepped wedge trial.,"BACKGROUND


Tuberculosis is among the top-10 causes of mortality in children with more than 1 million children suffering from TB disease annually worldwide. The main challenge in young children is the difficulty in establishing an accurate diagnosis of active TB. The INPUT study is a stepped-wedge cluster-randomized intervention study aiming to assess the effectiveness of integrating TB services into child healthcare services on TB diagnosis capacities in children under 5 years of age.
METHODS


Two strategies will be compared: i) The standard of care, offering pediatric TB services based on national standard of care; ii) The intervention, with pediatric TB services integrated into child healthcare services: it consists of a package of training, supportive supervision, job aids, and logistical support to the integration of TB screening and diagnosis activities into pediatric services. The design is a cluster-randomized stepped-wedge of 12 study clusters in Cameroon and Kenya. The sites start enrolling participants under standard-of-care and will transition to the intervention at randomly assigned time points. We enroll children aged less than 5 years with a presumptive diagnosis of TB after obtaining caregiver written informed consent. The participants are followed through TB diagnosis and treatment, with clinical information prospectively abstracted from their medical records. The primary outcome is the proportion of TB cases diagnosed among children < 5 years old attending the child healthcare services. Secondary outcomes include: number of children screened for presumptive active TB; diagnosed; initiated on TB treatment; and completing treatment. We will also assess the cost-effectiveness of the intervention, its acceptability among health care providers and users, and fidelity of implementation.
DISCUSSION


Study enrolments started in May 2019, enrolments will be completed in October 2020 and follow up will be completed by June 2021. The study findings will be disseminated to national, regional and international audiences and will inform innovative approaches to integration of TB screening, diagnosis, and treatment initiation into child health care services.
TRIAL RESISTRATION


NCT03862261, initial release 12 February 2019.",2020,"The study findings will be disseminated to national, regional and international audiences and will inform innovative approaches to integration of TB screening, diagnosis, and treatment initiation into child health care services.
","['young children', 'children under 5\u2009years of age', 'children with more than 1 million children suffering from TB disease annually worldwide', 'enroll children aged less than 5 years with a presumptive diagnosis of TB after obtaining caregiver written informed consent', '12 study clusters in Cameroon and Kenya']",[],"['cost-effectiveness', 'proportion of TB cases diagnosed among children <\u20095\u2009years old attending the child healthcare services', ' number of children screened for presumptive active TB; diagnosed; initiated on TB treatment; and completing treatment', 'TB diagnosis capacities']","[{'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C1881839', 'cui_str': '1000000'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0006802', 'cui_str': 'Cameroon'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}]",[],"[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0557829', 'cui_str': 'Healthcare services'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]",,0.169015,"The study findings will be disseminated to national, regional and international audiences and will inform innovative approaches to integration of TB screening, diagnosis, and treatment initiation into child health care services.
","[{'ForeName': 'Lise', 'Initials': 'L', 'LastName': 'Denoeud-Ndam', 'Affiliation': 'EGPAF, Geneva, Switzerland. ldenoeud@pedaids.org.'}, {'ForeName': 'Rose', 'Initials': 'R', 'LastName': 'Otieno-Masaba', 'Affiliation': 'EGPAF, Nairobi, Kenya.'}, {'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Tchounga', 'Affiliation': 'EGPAF, Yaounde, Cameroon.'}, {'ForeName': 'Rhoderick', 'Initials': 'R', 'LastName': 'Machekano', 'Affiliation': 'EGPAF, Washington DC, USA.'}, {'ForeName': 'Leonie', 'Initials': 'L', 'LastName': 'Simo', 'Affiliation': 'EGPAF, Yaounde, Cameroon.'}, {'ForeName': 'Joseph Phelix', 'Initials': 'JP', 'LastName': 'Mboya', 'Affiliation': 'EGPAF, Nairobi, Kenya.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Kose', 'Affiliation': 'EGPAF, Nairobi, Kenya.'}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Tchendjou', 'Affiliation': 'EGPAF, Yaounde, Cameroon.'}, {'ForeName': 'Anne-Cécile Zoung-Kanyi', 'Initials': 'AZ', 'LastName': 'Bissek', 'Affiliation': 'Ministry of Public Health, Yaounde, Cameroon.'}, {'ForeName': 'Gordon Odhiambo', 'Initials': 'GO', 'LastName': 'Okomo', 'Affiliation': 'Ministry of Health, Homa Bay, Kenya.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Casenghi', 'Affiliation': 'EGPAF, Geneva, Switzerland.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Cohn', 'Affiliation': 'EGPAF, Geneva, Switzerland.'}, {'ForeName': 'Appolinaire', 'Initials': 'A', 'LastName': 'Tiam', 'Affiliation': 'EGPAF, Washington DC, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMC public health,['10.1186/s12889-020-08741-2']
27,32375754,Evaluation of an internet-based intervention for service members of the German armed forces with deployment-related posttraumatic stress symptoms.,"BACKGROUND


The present study was designed to evaluate the efficacy of a therapist-guided internet-based cognitive-behavioral therapy (iCBT) intervention for service members of the German Armed Forces with posttraumatic stress disorder (PTSD). The iCBT was adapted from Interapy, a trauma-focused evidence-based treatment based on prolonged exposure and cognitive restructuring. It lasted for 5 weeks and included 10 writing assignments (twice a week). The program included a reminder function if assignments were overdue, but no multimedia elements. Therapeutic written feedback was provided asynchronously within one working day.
METHODS


Male active and former military service members were recruited from the German Armed Forces. Diagnoses were assessed with the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) and the Mini-International Neuropsychiatric Interview. Psychopathology was assessed at pre-treatment, post-treatment, and 3-month follow-up. Severity of PTSD was the primary outcome and anxiety was the secondary outcome. Participants were randomly allocated to a treatment group that received iCBT immediately or to a waitlist group that received iCBT after 6 weeks. Due to the overall small sample size (n = 37), the two groups were collapsed for the statistical analyses. Change during the intervention period was investigated using latent-change score models.
RESULTS


Improvements in the CAPS-5 were small and not statistically significant. For anxiety, small significant improvements were observed from pre- to follow-up assessment. The dropout rate was 32.3%.
CONCLUSIONS


The low treatment utilization and the high dropout rate are in line with previous findings on treatment of service members. The interpretation of the current null results for the efficacy of iCBT is limited due to the small sample size, however for military samples effect estimates were also smaller in other recent studies. Our results demonstrate the need to identify factors influencing treatment engagement and efficacy in veterans.
TRIAL REGISTRATION


Australian Clinical Trials Registry ACTRN12616000956404.",2020,Participants were randomly allocated to a treatment group that received iCBT immediately or to a waitlist group that received iCBT after 6 weeks.,"['Male active and former military service members were recruited from the German Armed Forces', 'service members of the German Armed Forces with posttraumatic stress disorder (PTSD', 'service members of the German armed forces with deployment-related posttraumatic stress symptoms']","['iCBT immediately or to a waitlist group that received iCBT', 'iCBT', 'internet-based intervention', 'therapist-guided internet-based cognitive-behavioral therapy (iCBT) intervention']","['Clinician-Administered PTSD Scale for DSM-5 (CAPS-5', 'Psychopathology', 'dropout rate']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0336524', 'cui_str': 'Military services member'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0521991', 'cui_str': 'Symptoms of stress'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3898714', 'cui_str': 'Internet Intervention'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}]",,0.0412261,Participants were randomly allocated to a treatment group that received iCBT immediately or to a waitlist group that received iCBT after 6 weeks.,"[{'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Niemeyer', 'Affiliation': 'Division of Clinical Psychological Intervention, Department of Education and Psychology, Freie Universität Berlin, Freie Universität Berlin, Schwendenerstr. 27, 14195, Berlin, Germany. hniemeyer@zedat.fu-berlin.de.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Knaevelsrud', 'Affiliation': 'Division of Clinical Psychological Intervention, Department of Education and Psychology, Freie Universität Berlin, Freie Universität Berlin, Schwendenerstr. 27, 14195, Berlin, Germany.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Schumacher', 'Affiliation': 'Division of Clinical Psychological Intervention, Department of Education and Psychology, Freie Universität Berlin, Freie Universität Berlin, Schwendenerstr. 27, 14195, Berlin, Germany.'}, {'ForeName': 'Sinha', 'Initials': 'S', 'LastName': 'Engel', 'Affiliation': 'Division of Clinical Psychological Intervention, Department of Education and Psychology, Freie Universität Berlin, Freie Universität Berlin, Schwendenerstr. 27, 14195, Berlin, Germany.'}, {'ForeName': 'Annika', 'Initials': 'A', 'LastName': 'Kuester', 'Affiliation': 'Division of Clinical Psychological Intervention, Department of Education and Psychology, Freie Universität Berlin, Freie Universität Berlin, Schwendenerstr. 27, 14195, Berlin, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Burchert', 'Affiliation': 'Division of Clinical Psychological Intervention, Department of Education and Psychology, Freie Universität Berlin, Freie Universität Berlin, Schwendenerstr. 27, 14195, Berlin, Germany.'}, {'ForeName': 'Beate', 'Initials': 'B', 'LastName': 'Muschalla', 'Affiliation': 'Department of Clinical Psychology, Psychotherapy and Diagnostics, Institute of Psychology, Technische Universität Braunschweig, Braunschweig, Germany.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Weiss', 'Affiliation': 'Division of Clinical Psychological Intervention, Department of Education and Psychology, Freie Universität Berlin, Freie Universität Berlin, Schwendenerstr. 27, 14195, Berlin, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Spies', 'Affiliation': 'Division of Clinical Psychological Intervention, Department of Education and Psychology, Freie Universität Berlin, Freie Universität Berlin, Schwendenerstr. 27, 14195, Berlin, Germany.'}, {'ForeName': 'Heinrich', 'Initials': 'H', 'LastName': 'Rau', 'Affiliation': 'German Armed Forces, Military Hospital Berlin, Department for Military Mental Health, Berlin, Germany.'}, {'ForeName': 'Gerd-Dieter', 'Initials': 'GD', 'LastName': 'Willmund', 'Affiliation': 'German Armed Forces, Military Hospital Berlin, Department for Military Mental Health, Berlin, Germany.'}]",BMC psychiatry,['10.1186/s12888-020-02595-z']
28,32377773,Discoloration of surface sealants by plaque disclosing solution.,"PURPOSE


Surface sealants are widely used as a prevention strategy and are indicated for young patients with insufficient oral hygiene who also need plaque removal by professional tooth cleaning. The aim of this study was to evaluate discoloration of surface sealants by plaque disclosing solutions and to test to what extent this discoloration can be reduced again by professional tooth cleaning.
METHODS


In all, 96 extracted lesion-free human teeth were randomly assigned to treatment with either Pro Seal® (PS; Opal Orthodontics, South Jordan, UT, USA) or Opal®Seal™ (OS; Reliance Orthodontic Products, Itasca, IL, USA). Color evaluations after application of the plaque disclosing solution Mira-2-Ton® (Hager & Werken, Duisburg, Germany) were performed using a clinical spectrophotometer. Staining and polishing were repeated once. Color differences (∆E) above 3.77 were regarded as clinically relevant.
RESULTS


All sealants showed high, clinically relevant ∆E values after the first staining. Polishing led to significantly decreased ∆E values on PS-treated teeth; however, the median ∆E value remained above the clinically relevant threshold. Polishing on OS-treated teeth only slightly reduced ∆E values. After professional tooth cleaning both PS and OS showed clinically relevant ∆E values.
CONCLUSION


Surface sealants show clinically relevant discoloration after exposure to plaque disclosing solution under in vitro conditions. Such discolorations could not be removed by professional tooth cleaning. Thus, in clinical practice, plaque disclosing solutions might cause esthetic deficits in surface sealant-treated teeth. The impact of plaque disclosing solutions under clinical conditions (e.g., in the presence of saliva and by various aspects of a person's nutrition) should be investigated in clinical studies.",2020,"Polishing led to significantly decreased ∆E values on PS-treated teeth; however, the median ∆E value remained above the clinically relevant threshold.","['young patients with insufficient oral hygiene who also need plaque removal by professional tooth cleaning', '96 extracted lesion-free human teeth']","['Pro Seal® (PS; Opal Orthodontics, South Jordan, UT, USA) or Opal®Seal']",['∆E values'],"[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0029164', 'cui_str': 'Dental Hygiene'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0542277', 'cui_str': 'Cleans drug injection equipment'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C1570472', 'cui_str': 'Pro Seal'}, {'cui': 'C0084990', 'cui_str': 'VPDA protocol'}, {'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C0022418', 'cui_str': 'Jordan'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0036492', 'cui_str': 'Seal'}]","[{'cui': 'C1273875', 'cui_str': 'Values (community)'}]",96.0,0.0759057,"Polishing led to significantly decreased ∆E values on PS-treated teeth; however, the median ∆E value remained above the clinically relevant threshold.","[{'ForeName': 'Sinan', 'Initials': 'S', 'LastName': 'Şen', 'Affiliation': 'Department of Orthodontics and Dentofacial Orthopaedics, Dental School, University of Heidelberg, Im Neuenheimer Feld\xa0400, 69120, Heidelberg, Germany. sinan.sen@med.uni-heidelberg.de.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Erber', 'Affiliation': 'Department of Orthodontics and Dentofacial Orthopaedics, Dental School, University of Heidelberg, Im Neuenheimer Feld\xa0400, 69120, Heidelberg, Germany.'}, {'ForeName': 'Gözde', 'Initials': 'G', 'LastName': 'Şen', 'Affiliation': 'MVZ Dentale Praxisklinik, Dr. Dilling & Kollegen GmbH, Fleiner Straße\xa03, 74072, Heilbronn, Germany.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Deurer', 'Affiliation': 'Department of Orthodontics and Dentofacial Orthopaedics, Dental School, University of Heidelberg, Im Neuenheimer Feld\xa0400, 69120, Heidelberg, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Zingler', 'Affiliation': 'Department of Orthodontics and Dentofacial Orthopaedics, Dental School, University of Heidelberg, Im Neuenheimer Feld\xa0400, 69120, Heidelberg, Germany.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Lux', 'Affiliation': 'Department of Orthodontics and Dentofacial Orthopaedics, Dental School, University of Heidelberg, Im Neuenheimer Feld\xa0400, 69120, Heidelberg, Germany.'}]",Journal of orofacial orthopedics = Fortschritte der Kieferorthopadie : Organ/official journal Deutsche Gesellschaft fur Kieferorthopadie,['10.1007/s00056-020-00227-5']
29,32383013,Preoperative antibiotic prophylaxis regimen in brain tumour surgery in Sweden: a quasi-experimental study.,"BACKGROUND


There has been varied clinical practice concerning antibiotic prophylaxis in patients undergoing craniotomy. In Sweden, both Cloxacillin and Cefuroxime have frequently been used. We aimed to study the clinical effectiveness of these two regimens.
METHODS


A quasi-experimental design was used. The sample consisted of 580 adult (> 18 years) patients operated 2012-2015, of which 375 received Cloxacillin (pre-intervention group) and 205 received Cefuroxime (intervention group). Primary endpoint was the incidence of surgical site infection (SSI) 12 months after surgery, while secondary endpoints were the need for reoperation due to SSI, the amount antibiotics used and the number of visits in the outpatient clinic related to SSI. A control group from another institution was reviewed to rule out clinical trial effects.
RESULTS


When analysed by intention to treat, the pre-intervention group had a significant higher incidence of SSI, 13.3% (50/375) vs 5.4% (11/205) in the intervention group (p < 0.01). A treatment per protocol analysis confirmed the result. The number of reoperations due to SSI were significantly reduced in the intervention group, 3.4% (7/205) vs 8.3% (31/375) (p = 0.02), as was the total antibiotic use (p = 0.03) and the number of visits in the outpatient clinic (p < 0.01). In the control group, the reoperation rate as result of SSI was lower (p = 0.02) prior to the opposite change from Cefuroxime to Cloxacillin, 1.8% (27/1529) vs 3.1% (43/1378).
CONCLUSION


In Sweden, Cefuroxime as prophylaxis in brain tumour surgery by craniotomy seems to be superior to Cloxacillin.",2020,"In the control group, the reoperation rate as result of SSI was lower (p = 0.02) prior to the opposite change from Cefuroxime to Cloxacillin, 1.8% (27/1529) vs 3.1% (43/1378).
","['patients undergoing craniotomy', '580 adult (>\u200918\xa0years) patients operated 2012-2015, of which 375 received', 'brain tumour surgery in Sweden']","['Cefuroxime', 'Preoperative antibiotic prophylaxis regimen', 'Cloxacillin', 'Cloxacillin (pre-intervention group) and 205 received Cefuroxime', 'Cloxacillin and Cefuroxime']","['number of reoperations due to SSI', 'incidence of SSI', 'total antibiotic use', 'incidence of surgical site infection (SSI', 'reoperation rate as result of SSI', 'number of visits in the outpatient clinic', 'need for reoperation due to SSI, the amount antibiotics used and the number of visits in the outpatient clinic related to SSI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010280', 'cui_str': 'Craniotomy'}, {'cui': 'C4517818', 'cui_str': '580'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517745', 'cui_str': '375'}, {'cui': 'C0006118', 'cui_str': 'Neoplasm of brain'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}]","[{'cui': 'C0007562', 'cui_str': 'Cefuroxime'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0282638', 'cui_str': 'Antibiotic prophylaxis'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0009077', 'cui_str': 'Cloxacillin'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}]",580.0,0.0480861,"In the control group, the reoperation rate as result of SSI was lower (p = 0.02) prior to the opposite change from Cefuroxime to Cloxacillin, 1.8% (27/1529) vs 3.1% (43/1378).
","[{'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Skyrman', 'Affiliation': 'Department of Neurosurgery, Karolinska University Hospital, 171 76, Stockholm, Sweden. simon.skyrman@sll.se.'}, {'ForeName': 'Jiri', 'Initials': 'J', 'LastName': 'Bartek', 'Affiliation': 'Department of Neurosurgery, Karolinska University Hospital, 171 76, Stockholm, Sweden.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Haghighi', 'Affiliation': 'Department of Neurosurgery, Karolinska University Hospital, 171 76, Stockholm, Sweden.'}, {'ForeName': 'Ida', 'Initials': 'I', 'LastName': 'Fornebo', 'Affiliation': 'Department of Neurosurgery, Karolinska University Hospital, 171 76, Stockholm, Sweden.'}, {'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Skoglund', 'Affiliation': 'Department of Neurosurgery, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Asgeir Store', 'Initials': 'AS', 'LastName': 'Jakola', 'Affiliation': 'Department of Neurosurgery, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Ann-Christin', 'Initials': 'AC', 'LastName': 'von Vogelsang', 'Affiliation': 'Department of Neurosurgery, Karolinska University Hospital, 171 76, Stockholm, Sweden.'}, {'ForeName': 'Petter', 'Initials': 'P', 'LastName': 'Förander', 'Affiliation': 'Department of Neurosurgery, Karolinska University Hospital, 171 76, Stockholm, Sweden.'}]",Acta neurochirurgica,['10.1007/s00701-020-04309-6']
30,32380239,Effects of Partial Sleep Deprivation on Braking Response of Drivers in Hazard Scenarios.,"This study aimed at modeling the Response Time (RT) and Total Braking Time (TBT) of drivers under Partial Sleep Deprivation (PSD). Fifty male participants drove the driving simulator in three experimental conditions: two test sessions and a baseline. The two test sessions were conducted after one and two nights of PSD (sleep = 4.25 ± 0.5 h), respectively. Sleep reduction was recorded using a wrist-worn Actiwatch. The baseline session was conducted after full rest (7-8 h sleep/day for a week). The order of test sessions and baseline was randomized. Each test included two hazard events: 1) pedestrians crossing a road and 2) parked vehicles merging into a roadway. Karolinska Sleepiness Scale (KSS) and Sleepiness Symptoms Questionnaire (SSQ) ratings were also recorded during each drive. Four separate models using parametric accelerated failure time (AFT) with Weibull distribution were developed for RT and TBT in the two events. The models were chosen with clustered heterogeneity to account for intra-group heterogeneity due to repeated measures across tests. In the case of pedestrians crossing event, RT increased by 10% in the first test session and no significant effect observed on RT in the second test session. The overall TBT reduced by 25% and 28% during the first and second PSD sessions, respectively. In the case of vehicle merging event, both response time and total braking time delayed by 44% and 17% respectively after PSD. Other factors such as age, experience, work-rest hours, KSS and SSQ rating, often exercising, approaching speed and braking force were also found significant in the analysis. The parametric AFT approach adopted in this study showed the change in 'response time' and 'total braking time' concerning the type of hazard scenario and partial sleep-deprivation.",2020,Four separate models using parametric accelerated failure time (AFT) with Weibull distribution were developed for RT and TBT in the two events.,"['Fifty male participants', 'Drivers in Hazard Scenarios']",['Partial Sleep Deprivation'],"['Sleep reduction', 'response time and total braking time delayed', 'pedestrians crossing a road and 2) parked vehicles merging into a roadway', 'Karolinska Sleepiness Scale (KSS) and Sleepiness Symptoms Questionnaire (SSQ) ratings', 'overall TBT', 'Response Time (RT) and Total Braking Time (TBT) of drivers under Partial Sleep Deprivation (PSD']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0684312', 'cui_str': 'Vehicle driver'}]","[{'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0037316', 'cui_str': 'Sleep deprivation'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0337108', 'cui_str': 'Brake'}, {'cui': 'C0522486', 'cui_str': 'Delay time'}, {'cui': 'C0450063', 'cui_str': 'Pedestrian'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0442650', 'cui_str': 'Road'}, {'cui': 'C0237771', 'cui_str': 'Parks, Recreational'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0684312', 'cui_str': 'Vehicle driver'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0037316', 'cui_str': 'Sleep deprivation'}]",50.0,0.023591,Four separate models using parametric accelerated failure time (AFT) with Weibull distribution were developed for RT and TBT in the two events.,"[{'ForeName': 'Kirti', 'Initials': 'K', 'LastName': 'Mahajan', 'Affiliation': 'Transportation Systems Engineering, Department of Civil Engineering, Indian Institute of Technology (IIT) Bombay, Powai, Mumbai 400 076, India.'}, {'ForeName': 'Nagendra R', 'Initials': 'NR', 'LastName': 'Velaga', 'Affiliation': 'Transportation Systems Engineering, Department of Civil Engineering, Indian Institute of Technology (IIT) Bombay, Powai, Mumbai 400 076, India. Electronic address: n.r.velaga@iitb.ac.in.'}]",Accident; analysis and prevention,['10.1016/j.aap.2020.105545']
31,32384147,Impact of arginine therapy on mitochondrial function in children with sickle cell disease during vaso-occlusive pain.,"Altered mitochondrial function occurs in sickle cell disease (SCD), due in part to low nitric oxide (NO) bioavailability. Arginine, the substrate for NO production, becomes acutely deficient in SCD patients with vaso-occlusive pain episodes (VOE). To determine if arginine improves mitochondrial function, 12 children with SCD-VOE (13.6 ± 3 years; 67% male; 75% hemoglobin-SS) were randomized to 1 of 3 arginine doses: (1) 100 mg/kg IV 3 times/day (TID); (2) loading dose (200 mg/kg) then 100 mg/kg TID; or (3) loading dose (200 mg/kg) followed by continuous infusion (300 mg/kg per day) until discharge. Platelet-rich plasma mitochondrial activity, protein expression, and protein-carbonyls were measured from emergency department (ED) presentation vs discharge. All VOE subjects at ED presentation had significantly decreased complex-V activity compared to a steady-state cohort. Notably, complex-V activity was increased at discharge in subjects from all 3 arginine-dosing schemes; greatest increase occurred with a loading dose (P < .001). Although complex-IV and citrate synthase activities were similar in VOE platelets vs steady state, enzyme activities were significantly increased in VOE subjects after arginine-loading dose treatment. Arginine also decreased protein-carbonyl levels across all treatment doses (P < .01), suggesting a decrease in oxidative stress. Arginine therapy increases mitochondrial activity and reduces oxidative stress in children with SCD/VOE. This trial was registered at www.clinicaltrials.gov as #NCT02536170.",2020,"Arginine therapy also decreased protein-carbonyl levels across all treatment doses (p<0.01), suggesting a decrease in oxidative stress.","['Children with Sickle Cell Disease during Vaso-occlusive Pain', 'sickle cell disease (SCD', 'children with SCD/VOE', 'SCD patients with vaso-occlusive-painful-events (VOE', '12 children with SCD hospitalized for VOE (age 13.6±3 years, 67% male, 75% HbSS']","['arginine therapy', 'Arginine therapy', 'arginine', 'Arginine Therapy']","['mitochondrial activity', 'oxidative stress', 'complex-V activity', 'protein-carbonyl levels', 'Platelet-rich-plasma mitochondrial activity, protein expression, and protein-carbonyls', 'Mitochondrial Function', 'VOE platelets vs. steady state, enzyme activities']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0002895', 'cui_str': 'Sickling disorder due to hemoglobin S'}, {'cui': 'C1947917', 'cui_str': 'Occluded'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0026237', 'cui_str': 'Mitochondrion'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0069436', 'cui_str': 'oligomycin sensitivity-conferring protein'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0243102', 'cui_str': 'enzyme activity'}]",12.0,0.0192241,"Arginine therapy also decreased protein-carbonyl levels across all treatment doses (p<0.01), suggesting a decrease in oxidative stress.","[{'ForeName': 'Claudia R', 'Initials': 'CR', 'LastName': 'Morris', 'Affiliation': 'Department of Pediatrics, Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Lou Ann S', 'Initials': 'LAS', 'LastName': 'Brown', 'Affiliation': 'Department of Pediatrics, Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Reynolds', 'Affiliation': 'Department of Pharmacology & Chemical Biology, Vascular Medicine Institute, Center for Metabolism & Mitochondrial Medicine (C3M), University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Carlton D', 'Initials': 'CD', 'LastName': 'Dampier', 'Affiliation': 'Department of Pediatrics, Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Lane', 'Affiliation': 'Department of Pediatrics, Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Watt', 'Affiliation': ""Children's Healthcare of Atlanta, Atlanta, GA; and.""}, {'ForeName': 'Polly', 'Initials': 'P', 'LastName': 'Kumari', 'Affiliation': 'Department of Pediatrics, Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Harris', 'Affiliation': 'Department of Pediatrics, Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Shaminy', 'Initials': 'S', 'LastName': 'Manoranjithan', 'Affiliation': ""Children's Healthcare of Atlanta, Atlanta, GA; and.""}, {'ForeName': 'Reshika D', 'Initials': 'RD', 'LastName': 'Mendis', 'Affiliation': ""Children's Healthcare of Atlanta, Atlanta, GA; and.""}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Figueroa', 'Affiliation': 'Department of Pediatrics, Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Sruti', 'Initials': 'S', 'LastName': 'Shiva', 'Affiliation': 'Department of Pharmacology & Chemical Biology, Vascular Medicine Institute, Center for Metabolism & Mitochondrial Medicine (C3M), University of Pittsburgh, Pittsburgh, PA.'}]",Blood,['10.1182/blood.2019003672']
32,32388647,"Suprascapular nerve block in hemiplegic shoulder pain: comparison of the effectiveness of placebo, local anesthetic, and corticosteroid injections-a randomized controlled study.","BACKGROUND


Shoulder pain is a common complication of hemiplegic patients that can interrupt their rehabilitation program and is associated with poorer outcomes. The usefulness of the suprascapular nerve block. (SSNB) in the stroke population has been suggested, but some concerns still remain.
OBJECTIVES


To investigate the effect of SSNB on pain intensity and passive range ofmotion (PROM) in patients with hemiplegic shoulder pain (HSP).
STUDY DESIGN


A prospective, double blind, randomized controlled trial was conductedin 34 stroke patients with HSP. They were randomly divided into three groups: Localanesthetic (LA) injection into the trapezius muscle (placebo group), LA injection into thesuprascapular notch, and LA and corticosteroid (CS) injections into the suprascapularnotch.The main outcome was visual analog scale (VAS) scores evaluated before andafter administration of the injection at 1 hour, 1 week, and 1 month.
RESULTS


There were significant decreases in the VAS scores with all three injections at all follow-up time points (p: 0.001 for the placebo group, p <0.001 for the LA group, and p <0.001 for the LA+CS group). When changes in VAS scores were compared between the groups, the LA+CS group demonstrated a higher decrease in VAS than the placebo group. Improvement in the PROM was seen only in the LA and LA+CS groups.
CONCLUSIONS


The findings of this study support the use of an SSNB with or without CS, to increase the range of motion in the affected shoulder, especially during the rehabilitation period.",2020,"There were significant decreases in the VAS scores with all three injections at all follow-up time points (p: 0.001 for the placebo group, p <0.001 for the LA group, and p <0.001 for the LA+CS group).","['patients with hemiplegic shoulder pain (HSP', 'hemiplegic patients', 'hemiplegic shoulder pain', '34 stroke patients with HSP']","['Suprascapular nerve block', 'SSNB', 'LA+CS', 'Localanesthetic (LA) injection into the trapezius muscle (placebo group), LA injection into thesuprascapular notch, and LA and corticosteroid (CS) injections into the suprascapularnotch', 'placebo, local anesthetic, and corticosteroid injections', 'placebo']","['visual analog scale (VAS) scores', 'PROM', 'pain intensity and passive range ofmotion (PROM', 'VAS', 'VAS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C0394703', 'cui_str': 'Injection of anesthetic agent into suprascapular nerve'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0224361', 'cui_str': 'Structure of trapezius muscle'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205316', 'cui_str': 'Notched'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",,0.235594,"There were significant decreases in the VAS scores with all three injections at all follow-up time points (p: 0.001 for the placebo group, p <0.001 for the LA group, and p <0.001 for the LA+CS group).","[{'ForeName': 'Rana', 'Initials': 'R', 'LastName': 'Terlemez', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Saglik Bilimleri University, Sisli Hamidiye Etfal Education and Research Hospital, Istanbul, Turkey. ranakaynar@hotmail.com.'}, {'ForeName': 'Selda', 'Initials': 'S', 'LastName': 'Çiftçi', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Saglik Bilimleri University, Sisli Hamidiye Etfal Education and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Mahir', 'Initials': 'M', 'LastName': 'Topaloglu', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Mahir Topaloglu; MD. Koc University Hospital, Istanbul, Turkey.'}, {'ForeName': 'Beril', 'Initials': 'B', 'LastName': 'Dogu', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Saglik Bilimleri University, Sisli Hamidiye Etfal Education and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Figen', 'Initials': 'F', 'LastName': 'Yilmaz', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Saglik Bilimleri University, Sisli Hamidiye Etfal Education and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Banu', 'Initials': 'B', 'LastName': 'Kuran', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Saglik Bilimleri University, Sisli Hamidiye Etfal Education and Research Hospital, Istanbul, Turkey.'}]",Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology,['10.1007/s10072-020-04362-0']
33,32393158,Blending Traditional Vocational Services and Individualized Placement and Support for Formerly Incarcerated Veterans.,"OBJECTIVE


This study compared two vocational programs: the About Face Vocational Program (AFVP), a traditional group-based vocational program created for formerly incarcerated veterans, and a hybrid program combining the AFVP with principles of individual placement and support-supported employment.
METHODS


The study evaluated 111 veterans with at least one felony conviction who had a mental illness, substance use disorder, or both. Veterans were randomly assigned to either vocational condition.
RESULTS


Veterans in the hybrid condition, compared with the AFVP alone, were more likely to find employment, had higher rates of full-time employment, and earned significantly more money over the course of the study. A comparison of only participants who found employment showed higher rates of full-time employment for veterans in the hybrid condition but similarities between the two groups in other measures of employment success.
CONCLUSIONS


Blended models of vocational services for veterans with mental illness, substance use disorders, or both are effective at returning formerly incarcerated veterans to competitive employment.",2020,"RESULTS


Veterans in the hybrid condition, compared with the AFVP alone, were more likely to find employment, had higher rates of full-time employment, and earned significantly more money over the course of the study.","['Formerly Incarcerated Veterans', 'Veterans in the hybrid condition', '111 veterans with at least one felony conviction who had a mental illness, substance use disorder, or both', 'veterans with mental illness']","['Face Vocational Program (AFVP), a traditional group-based vocational program created for formerly incarcerated veterans, and a hybrid program combining the AFVP with principles of individual placement and support-supported employment', 'vocational condition', 'AFVP']",['rates of full-time employment'],"[{'cui': 'C0392751', 'cui_str': 'In prison'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}]","[{'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0392751', 'cui_str': 'In prison'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C4750554', 'cui_str': 'Individual Placement and Support'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0682295', 'cui_str': 'Full-time employment'}]",111.0,0.0219773,"RESULTS


Veterans in the hybrid condition, compared with the AFVP alone, were more likely to find employment, had higher rates of full-time employment, and earned significantly more money over the course of the study.","[{'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'LePage', 'Affiliation': 'U.S. Department of Veterans Affairs (VA) North Texas Health Care System, Dallas (LePage, Rock); Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas (LePage); Dallas VA Research Corporation, Dallas (Crawford, Parish Johnson, Washington); College of Nursing and Health Innovation, University of Texas at Arlington, Arlington (Cipher); Department of Psychology, Colorado State University, Fort Collins (Anderson); James A. Haley Veterans Hospital, and Department of Rehabilitation and Mental Health Counseling, University of South Florida, Tampa (Ottomanelli).'}, {'ForeName': 'April M', 'Initials': 'AM', 'LastName': 'Crawford', 'Affiliation': 'U.S. Department of Veterans Affairs (VA) North Texas Health Care System, Dallas (LePage, Rock); Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas (LePage); Dallas VA Research Corporation, Dallas (Crawford, Parish Johnson, Washington); College of Nursing and Health Innovation, University of Texas at Arlington, Arlington (Cipher); Department of Psychology, Colorado State University, Fort Collins (Anderson); James A. Haley Veterans Hospital, and Department of Rehabilitation and Mental Health Counseling, University of South Florida, Tampa (Ottomanelli).'}, {'ForeName': 'Daisha J', 'Initials': 'DJ', 'LastName': 'Cipher', 'Affiliation': 'U.S. Department of Veterans Affairs (VA) North Texas Health Care System, Dallas (LePage, Rock); Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas (LePage); Dallas VA Research Corporation, Dallas (Crawford, Parish Johnson, Washington); College of Nursing and Health Innovation, University of Texas at Arlington, Arlington (Cipher); Department of Psychology, Colorado State University, Fort Collins (Anderson); James A. Haley Veterans Hospital, and Department of Rehabilitation and Mental Health Counseling, University of South Florida, Tampa (Ottomanelli).'}, {'ForeName': 'Kemol', 'Initials': 'K', 'LastName': 'Anderson', 'Affiliation': 'U.S. Department of Veterans Affairs (VA) North Texas Health Care System, Dallas (LePage, Rock); Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas (LePage); Dallas VA Research Corporation, Dallas (Crawford, Parish Johnson, Washington); College of Nursing and Health Innovation, University of Texas at Arlington, Arlington (Cipher); Department of Psychology, Colorado State University, Fort Collins (Anderson); James A. Haley Veterans Hospital, and Department of Rehabilitation and Mental Health Counseling, University of South Florida, Tampa (Ottomanelli).'}, {'ForeName': 'Avery', 'Initials': 'A', 'LastName': 'Rock', 'Affiliation': 'U.S. Department of Veterans Affairs (VA) North Texas Health Care System, Dallas (LePage, Rock); Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas (LePage); Dallas VA Research Corporation, Dallas (Crawford, Parish Johnson, Washington); College of Nursing and Health Innovation, University of Texas at Arlington, Arlington (Cipher); Department of Psychology, Colorado State University, Fort Collins (Anderson); James A. Haley Veterans Hospital, and Department of Rehabilitation and Mental Health Counseling, University of South Florida, Tampa (Ottomanelli).'}, {'ForeName': 'Julie A Parish', 'Initials': 'JAP', 'LastName': 'Johnson', 'Affiliation': 'U.S. Department of Veterans Affairs (VA) North Texas Health Care System, Dallas (LePage, Rock); Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas (LePage); Dallas VA Research Corporation, Dallas (Crawford, Parish Johnson, Washington); College of Nursing and Health Innovation, University of Texas at Arlington, Arlington (Cipher); Department of Psychology, Colorado State University, Fort Collins (Anderson); James A. Haley Veterans Hospital, and Department of Rehabilitation and Mental Health Counseling, University of South Florida, Tampa (Ottomanelli).'}, {'ForeName': 'Edward L', 'Initials': 'EL', 'LastName': 'Washington', 'Affiliation': 'U.S. Department of Veterans Affairs (VA) North Texas Health Care System, Dallas (LePage, Rock); Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas (LePage); Dallas VA Research Corporation, Dallas (Crawford, Parish Johnson, Washington); College of Nursing and Health Innovation, University of Texas at Arlington, Arlington (Cipher); Department of Psychology, Colorado State University, Fort Collins (Anderson); James A. Haley Veterans Hospital, and Department of Rehabilitation and Mental Health Counseling, University of South Florida, Tampa (Ottomanelli).'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Ottomanelli', 'Affiliation': 'U.S. Department of Veterans Affairs (VA) North Texas Health Care System, Dallas (LePage, Rock); Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas (LePage); Dallas VA Research Corporation, Dallas (Crawford, Parish Johnson, Washington); College of Nursing and Health Innovation, University of Texas at Arlington, Arlington (Cipher); Department of Psychology, Colorado State University, Fort Collins (Anderson); James A. Haley Veterans Hospital, and Department of Rehabilitation and Mental Health Counseling, University of South Florida, Tampa (Ottomanelli).'}]","Psychiatric services (Washington, D.C.)",['10.1176/appi.ps.201900421']
34,32393991,"Letter to the editor regarding ""Intramedullary fixation versus anatomically contoured plating of unstable fractures: a randomized control trial"" by Badenhorst et al.",,2020,,[],"['Letter to the editor regarding ""Intramedullary fixation versus anatomically contoured plating of unstable fractures']",[],[],"[{'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C1512957', 'cui_str': 'Intramedullary route'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0407295', 'cui_str': 'Fixation of fracture using plate'}, {'cui': 'C0559876', 'cui_str': 'Unstable fracture'}]",[],,0.0157977,,"[{'ForeName': 'Aditya', 'Initials': 'A', 'LastName': 'Aggarwal', 'Affiliation': 'Department of Orthopaedics, PGIMER, Sector 12, Chandigarh, India. dr.aditya.agg@gmail.com.'}, {'ForeName': 'Rajesh Kumar', 'Initials': 'RK', 'LastName': 'Rajnish', 'Affiliation': 'Department of Orthopaedics, PGIMER, Sector 12, Chandigarh, India.'}, {'ForeName': 'Vikas', 'Initials': 'V', 'LastName': 'Bachhal', 'Affiliation': 'Department of Orthopaedics, PGIMER, Sector 12, Chandigarh, India.'}]",International orthopaedics,['10.1007/s00264-020-04602-0']
35,32342662,A Combined Health Action Process Approach and mHealth Intervention to Increase Non-Sedentary Behaviours in Office-Working Adults-A Randomised Controlled Trial.,"BACKGROUND


Office-working adults represent an at-risk population for high levels of sedentary behaviour (SB), which has been associated with an increased risk for numerous chronic diseases. This study examined the effectiveness of a Health Action Process Approach (HAPA) based planning intervention augmented with tailored text messages to reduce workplace sitting time (primary outcome) and increase specific non-SBs (i.e. standing time, walking time, stretching time, break frequency, break duration). A secondary purpose was to examine relationships among HAPA volitional constructs and sedentary and non-SBs.
METHODS


Full-time office workers (M age   = 45.18 ± 11.33 years) from Canada were randomised into either a HAPA intervention (n = 29) or control (n = 31) condition. Workplace sitting time, time spent in specific non-SBs, and HAPA volitional constructs were assessed at baseline, weeks 2, 4, 6 (post-intervention), and 8 (follow-up).
RESULTS


Significant group by time interaction effects, that favoured the intervention group, were found for sitting time (p = .003, ɳ p   2   = .07), standing time (p = .019, ɳ p   2   = .05), and stretching time (p = .001, ɳ p   2   = .08) as well as for action planning (p < .001, ɳ p   2   = .20), coping planning (p < .001, ɳ p   2   = .18), and action control (p < .001, ɳ p   2   = .15). Significant correlations (p < .05) were also found between the HAPA constructs and time spent sitting, standing, walking, as well as break frequency.
CONCLUSIONS


Augmenting a HAPA-based planning intervention with text messages can reduce workplace sitting time in office workers.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT03461926.",2020,"Significant correlations (p < .05) were also found between the HAPA constructs and time spent sitting, standing, walking, as well as break frequency.
","['Office-working adults represent an at-risk population for high levels of sedentary behaviour (SB', '45.18\xa0±\xa011.33\xa0years) from Canada', 'Full-time office workers (M age  \xa0']","['HAPA intervention', 'Health Action Process Approach (HAPA) based planning intervention', 'Combined Health Action Process Approach and mHealth Intervention', 'HAPA-based planning intervention with text messages']","['specific non-SBs (i.e. standing time, walking time, stretching time, break frequency, break duration', 'standing time', 'action control', 'sitting time', 'HAPA constructs and time spent sitting, standing, walking, as well as break frequency', 'workplace sitting time', 'Workplace sitting time, time spent in specific non-SBs, and HAPA volitional constructs', 'coping planning', 'time interaction effects', 'stretching time']","[{'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0242444', 'cui_str': 'Populations at Risk'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0682295', 'cui_str': 'Full-time employment'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0003380', 'cui_str': 'Antimony'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0012931', 'cui_str': 'Recombinant DNA'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",,0.062468,"Significant correlations (p < .05) were also found between the HAPA constructs and time spent sitting, standing, walking, as well as break frequency.
","[{'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Rollo', 'Affiliation': 'The University of Western Ontario, London, Ontario, Canada.'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Prapavessis', 'Affiliation': 'The University of Western Ontario, London, Ontario, Canada.'}]",Applied psychology. Health and well-being,['10.1111/aphw.12201']
36,32347764,Air Pollutant Exposure and Stove Use Assessment Methods for the Household Air Pollution Intervention Network (HAPIN) Trial.,"BACKGROUND


High quality personal exposure data is fundamental to understanding the health implications of household energy interventions, interpreting analyses across assigned study arms, and characterizing exposure-response relationships for household air pollution. This paper describes the exposure data collection for the Household Air Pollution Intervention Network (HAPIN), a multicountry randomized controlled trial of liquefied petroleum gas stoves and fuel among 3,200 households in India, Rwanda, Guatemala, and Peru.
OBJECTIVES


The primary objectives of the exposure assessment are to estimate the exposure contrast achieved following a clean fuel intervention and to provide data for analyses of exposure-response relationships across a range of personal exposures.
METHODS


Exposure measurements are being conducted over the 3-y time frame of the field study. We are measuring fine particulate matter [PM  <   2.5 μ m  in aerodynamic diameter ( PM 2.5 )] with the Enhanced Children's MicroPEM™ (RTI International), carbon monoxide (CO) with the USB-EL-CO (Lascar Electronics), and black carbon with the OT21 transmissometer (Magee Scientific) in pregnant women, adult women, and children  < 1   year  of age, primarily via multiple 24-h personal assessments (three, six, and three measurements, respectively) over the course of the 18-month follow-up period using lightweight monitors. For children we are using an indirect measurement approach, combining data from area monitors and locator devices worn by the child. For a subsample (up to 10%) of the study population, we are doubling the frequency of measurements in order to estimate the accuracy of subject-specific typical exposure estimates. In addition, we are conducting ambient air monitoring to help characterize potential contributions of  PM 2.5  exposure from background concentration. Stove use monitors (Geocene) are being used to assess compliance with the intervention, given that stove stacking (use of traditional stoves in addition to the intervention gas stove) may occur.
CONCLUSIONS


The tools and approaches being used for HAPIN to estimate personal exposures build on previous efforts and take advantage of new technologies. In addition to providing key personal exposure data for this study, we hope the application and learnings from our exposure assessment will help inform future efforts to characterize exposure to household air pollution and for other contexts. https://doi.org/10.1289/EHP6422.",2020,"[PM  <   2.5 μ m  in aerodynamic diameter ( PM 2.5 )] with the Enhanced Children's MicroPEM™ (RTI International), carbon monoxide (CO) with the USB-EL-CO (Lascar Electronics), and black carbon with the OT21 transmissometer (Magee Scientific) in pregnant women, adult women, and children  ","['3,200 households in India, Rwanda, Guatemala, and Peru', 'pregnant women, adult women, and children']",['liquefied petroleum gas stoves'],[],"[{'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0035978', 'cui_str': 'Rwanda'}, {'cui': 'C0018367', 'cui_str': 'Guatemala'}, {'cui': 'C0031238', 'cui_str': 'Peru'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0303763', 'cui_str': 'Liquefied petroleum gas'}, {'cui': 'C0336754', 'cui_str': 'Stove'}]",[],3200.0,0.0431358,"[PM  <   2.5 μ m  in aerodynamic diameter ( PM 2.5 )] with the Enhanced Children's MicroPEM™ (RTI International), carbon monoxide (CO) with the USB-EL-CO (Lascar Electronics), and black carbon with the OT21 transmissometer (Magee Scientific) in pregnant women, adult women, and children  ","[{'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Johnson', 'Affiliation': 'Berkeley Air Monitoring Group, Berkeley, California, USA.'}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Steenland', 'Affiliation': 'Gangarosa Department of Environmental Health, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Piedrahita', 'Affiliation': 'Berkeley Air Monitoring Group, Berkeley, California, USA.'}, {'ForeName': 'Maggie L', 'Initials': 'ML', 'LastName': 'Clark', 'Affiliation': 'Department of Environmental and Radiological Health Sciences, Colorado State University, Fort Collins, Colorado, USA.'}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Pillarisetti', 'Affiliation': 'Gangarosa Department of Environmental Health, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'Kalpana', 'Initials': 'K', 'LastName': 'Balakrishnan', 'Affiliation': 'Department of Environmental Health Engineering, ICMR Center for Advanced Research on Air Quality, Climate and Health, Sri Ramachandra Institute for Higher Education and Research (Deemed University), Chennai, India.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Peel', 'Affiliation': 'Department of Environmental and Radiological Health Sciences, Colorado State University, Fort Collins, Colorado, USA.'}, {'ForeName': 'Luke P', 'Initials': 'LP', 'LastName': 'Naeher', 'Affiliation': 'Department of Environmental Health Science, College of Public Health, University of Georgia, Athens, Georgia, USA.'}, {'ForeName': 'Jiawen', 'Initials': 'J', 'LastName': 'Liao', 'Affiliation': 'Gangarosa Department of Environmental Health, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Wilson', 'Affiliation': 'Geocene, Vallejo, California, USA.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Sarnat', 'Affiliation': 'Gangarosa Department of Environmental Health, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'Lindsay J', 'Initials': 'LJ', 'LastName': 'Underhill', 'Affiliation': 'Division of Pulmonary and Critical Care, School of Medicine, Johns Hopkins University, Baltimore, Maryland, USA.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Burrowes', 'Affiliation': 'Division of Pulmonary and Critical Care, School of Medicine, Johns Hopkins University, Baltimore, Maryland, USA.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'McCracken', 'Affiliation': 'Center for Health Studies, Universidad del Valle de Guatemala, Guatemala City, Guatemala.'}, {'ForeName': 'Ghislaine', 'Initials': 'G', 'LastName': 'Rosa', 'Affiliation': 'Department of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Rosenthal', 'Affiliation': 'Division of Epidemiology and Population Studies, Fogarty International Center, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Sankar', 'Initials': 'S', 'LastName': 'Sambandam', 'Affiliation': 'Department of Environmental Health Engineering, ICMR Center for Advanced Research on Air Quality, Climate and Health, Sri Ramachandra Institute for Higher Education and Research (Deemed University), Chennai, India.'}, {'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'de Leon', 'Affiliation': 'Division of Pulmonary and Critical Care, School of Medicine, Johns Hopkins University, Baltimore, Maryland, USA.'}, {'ForeName': 'Miles A', 'Initials': 'MA', 'LastName': 'Kirby', 'Affiliation': 'Gangarosa Department of Environmental Health, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Kearns', 'Affiliation': 'Department of Environmental Health Engineering, ICMR Center for Advanced Research on Air Quality, Climate and Health, Sri Ramachandra Institute for Higher Education and Research (Deemed University), Chennai, India.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Checkley', 'Affiliation': 'Division of Pulmonary and Critical Care, School of Medicine, Johns Hopkins University, Baltimore, Maryland, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Clasen', 'Affiliation': 'Gangarosa Department of Environmental Health, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Environmental health perspectives,['10.1289/EHP6422']
37,32347765,Design and Rationale of the Biomarker Center of the Household Air Pollution Intervention Network (HAPIN) Trial.,"BACKGROUND


Biomarkers of exposure, susceptibility, and effect are fundamental for understanding environmental exposures, mechanistic pathways of effect, and monitoring early adverse outcomes. To date, no study has comprehensively evaluated a large suite and variety of biomarkers in household air pollution (HAP) studies in concert with exposure and outcome data. The Household Air Pollution Intervention Network (HAPIN) trial is a liquified petroleum gas (LPG) fuel/stove randomized intervention trial enrolling 800 pregnant women in each of four countries (i.e., Peru, Guatemala, Rwanda, and India). Their offspring will be followed from birth through 12 months of age to evaluate the role of pre- and postnatal exposure to HAP from biomass burning cookstoves in the control arm and LPG stoves in the intervention arm on growth and respiratory outcomes. In addition, up to 200 older adult women per site are being recruited in the same households to evaluate indicators of cardiopulmonary, metabolic, and cancer outcomes.
OBJECTIVES


Here we describe the rationale and ultimate design of a comprehensive biomarker plan to enable us to explore more fully how exposure is related to disease outcome.
METHODS


HAPIN enrollment and data collection began in May 2018 and will continue through August 2021. As a part of data collection, dried blood spot (DBS) and urine samples are being collected three times during pregnancy in pregnant women and older adult women. DBS are collected at birth for the child. DBS and urine samples are being collected from the older adult women and children three times throughout the child's first year of life. Exposure biomarkers that will be longitudinally measured in all participants include urinary hydroxy-polycyclic aromatic hydrocarbons, volatile organic chemical metabolites, metals/metalloids, levoglucosan, and cotinine. Biomarkers of effect, including inflammation, endothelial and oxidative stress biomarkers, lung cancer markers, and other clinically relevant measures will be analyzed in urine, DBS, or blood products from the older adult women. Similarly, genomic/epigenetic markers, microbiome, and metabolomics will be measured in older adult women samples.
DISCUSSION


Our study design will yield a wealth of biomarker data to evaluate, in great detail, the link between exposures and health outcomes. In addition, our design is comprehensive and innovative by including cutting-edge measures such as metabolomics and epigenetics. https://doi.org/10.1289/EHP5751.",2020,"The Household Air Pollution Intervention Network (HAPIN) trial is a liquified petroleum gas (LPG) fuel/stove randomized intervention trial enrolling 800 pregnant women in each of four countries (i.e., Peru, Guatemala, Rwanda, and India).","['older adult women', 'HAPIN enrollment and data collection began in May 2018 and will continue through August 2021', 'pregnant women and older adult women', '800 pregnant women in each of four countries (i.e., Peru, Guatemala, Rwanda, and India', '200 older adult women per site are being recruited in the same households to evaluate indicators of cardiopulmonary, metabolic, and cancer outcomes', 'older adult women samples']",['https://doi.org/10.1289/EHP5751'],"['DBS and urine samples', 'inflammation, endothelial and oxidative stress biomarkers, lung cancer markers']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0001873', 'cui_str': 'Air pollution'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0031238', 'cui_str': 'Peru'}, {'cui': 'C0018367', 'cui_str': 'Guatemala'}, {'cui': 'C0035978', 'cui_str': 'Rwanda'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]",[],"[{'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C1610733', 'cui_str': 'Urine specimen'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}]",800.0,0.124554,"The Household Air Pollution Intervention Network (HAPIN) trial is a liquified petroleum gas (LPG) fuel/stove randomized intervention trial enrolling 800 pregnant women in each of four countries (i.e., Peru, Guatemala, Rwanda, and India).","[{'ForeName': 'Dana Boyd', 'Initials': 'DB', 'LastName': 'Barr', 'Affiliation': 'Gangarosa Department of Environmental Health, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'Naveen', 'Initials': 'N', 'LastName': 'Puttaswamy', 'Affiliation': 'Department of Environmental Health Engineering, ICMR Center for Advanced Research on Air Quality, Climate and Health, Sri Ramachandra Institute for Higher Education and Research (Deemed University), Chennai, India.'}, {'ForeName': 'Lindsay M', 'Initials': 'LM', 'LastName': 'Jaacks', 'Affiliation': 'Department of Global Health and Population, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Steenland', 'Affiliation': 'Gangarosa Department of Environmental Health, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Rajkumar', 'Affiliation': 'Department of Environmental Health Engineering, ICMR Center for Advanced Research on Air Quality, Climate and Health, Sri Ramachandra Institute for Higher Education and Research (Deemed University), Chennai, India.'}, {'ForeName': 'Savannah', 'Initials': 'S', 'LastName': 'Gupton', 'Affiliation': 'Gangarosa Department of Environmental Health, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'P Barry', 'Initials': 'PB', 'LastName': 'Ryan', 'Affiliation': 'Gangarosa Department of Environmental Health, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'Kalpana', 'Initials': 'K', 'LastName': 'Balakrishnan', 'Affiliation': 'Department of Environmental Health Engineering, ICMR Center for Advanced Research on Air Quality, Climate and Health, Sri Ramachandra Institute for Higher Education and Research (Deemed University), Chennai, India.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Peel', 'Affiliation': 'Department of Environmental and Radiological Health Sciences, Colorado State University, Fort Collins, Colorado, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Checkley', 'Affiliation': 'Division of Pulmonary and Critical Care, School of Medicine, Johns Hopkins University, Baltimore, Maryland, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Clasen', 'Affiliation': 'Gangarosa Department of Environmental Health, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'Maggie L', 'Initials': 'ML', 'LastName': 'Clark', 'Affiliation': 'Department of Environmental and Radiological Health Sciences, Colorado State University, Fort Collins, Colorado, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Environmental health perspectives,['10.1289/EHP5751']
38,32347766,Design and Rationale of the HAPIN Study: A Multicountry Randomized Controlled Trial to Assess the Effect of Liquefied Petroleum Gas Stove and Continuous Fuel Distribution.,"BACKGROUND


Globally, nearly 3 billion people rely on solid fuels for cooking and heating, the vast majority residing in low- and middle-income countries (LMICs). The resulting household air pollution (HAP) is a leading environmental risk factor, accounting for an estimated 1.6 million premature deaths annually. Previous interventions of cleaner stoves have often failed to reduce exposure to levels that produce meaningful health improvements. There have been no multicountry field trials with liquefied petroleum gas (LPG) stoves, likely the cleanest scalable intervention.
OBJECTIVE


This paper describes the design and methods of an ongoing randomized controlled trial (RCT) of LPG stove and fuel distribution in 3,200 households in 4 LMICs (India, Guatemala, Peru, and Rwanda).
METHODS


We are enrolling 800 pregnant women at each of the 4 international research centers from households using biomass fuels. We are randomly assigning households to receive LPG stoves, an 18-month supply of free LPG, and behavioral reinforcements to the control arm. The mother is being followed along with her child until the child is 1 year old. Older adult women (40 to  < 80   years  of age) living in the same households are also enrolled and followed during the same period. Primary health outcomes are low birth weight, severe pneumonia incidence, stunting in the child, and high blood pressure (BP) in the older adult woman. Secondary health outcomes are also being assessed. We are assessing stove and fuel use, conducting repeated personal and kitchen exposure assessments of fine particulate matter with aerodynamic diameter  ≤ 2.5 μ m  ( PM 2.5 ), carbon monoxide (CO), and black carbon (BC), and collecting dried blood spots (DBS) and urinary samples for biomarker analysis. Enrollment and data collection began in May 2018 and will continue through August 2021. The trial is registered with ClinicalTrials.gov (NCT02944682).
CONCLUSIONS


This study will provide evidence to inform national and global policies on scaling up LPG stove use among vulnerable populations. https://doi.org/10.1289/EHP6407.",2020,"Primary health outcomes are low birth weight, severe pneumonia incidence, stunting in the child, and high blood pressure (BP) in the older adult woman.","['800 pregnant women at each of the 4 international research centers from households using biomass fuels', '3,200 households in 4 LMICs (India, Guatemala, Peru, and Rwanda', 'Older adult women (40 to  < 80 \u2009 years  of age) living in the same households are also enrolled and followed during the same period']","['Liquefied Petroleum Gas Stove and Continuous Fuel Distribution', 'LPG stoves', 'LPG stove and fuel distribution']","['low birth weight, severe pneumonia incidence, stunting in the child, and high blood pressure (BP', 'household air pollution (HAP', 'carbon monoxide (CO), and black carbon (BC), and collecting dried blood spots (DBS) and urinary samples for biomarker analysis']","[{'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0005535', 'cui_str': 'Biomass'}, {'cui': 'C0556991', 'cui_str': 'Fuel'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0018367', 'cui_str': 'Guatemala'}, {'cui': 'C0031238', 'cui_str': 'Peru'}, {'cui': 'C0035978', 'cui_str': 'Rwanda'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0303763', 'cui_str': 'Liquefied petroleum gas'}, {'cui': 'C0336754', 'cui_str': 'Stove'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0556991', 'cui_str': 'Fuel'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}]","[{'cui': 'C0024032', 'cui_str': 'Low Birth Weights'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0018273', 'cui_str': 'Growth disorder'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0001873', 'cui_str': 'Air pollution'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0007010', 'cui_str': 'Carbon Black'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]",800.0,0.14481,"Primary health outcomes are low birth weight, severe pneumonia incidence, stunting in the child, and high blood pressure (BP) in the older adult woman.","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Clasen', 'Affiliation': 'Department of Environmental Health, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Checkley', 'Affiliation': 'Division of Pulmonary and Critical Care, School of Medicine, Johns Hopkins University, Baltimore, Maryland, USA.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Peel', 'Affiliation': 'Department of Environmental and Radiological Health Sciences, Colorado State University, Fort Collins, Colorado, USA.'}, {'ForeName': 'Kalpana', 'Initials': 'K', 'LastName': 'Balakrishnan', 'Affiliation': 'Department of Environmental Health Engineering, ICMR Center for Advanced Research on Air Quality, Climate and Health, Sri Ramachandra Institute for Higher Education and Research (Deemed University), Chennai, Tamil Nadu, India.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'McCracken', 'Affiliation': 'Center for Health Studies, Universidad del Valle de Guatemala, Guatemala City, Guatemala.'}, {'ForeName': 'Ghislaine', 'Initials': 'G', 'LastName': 'Rosa', 'Affiliation': 'Department of Disease Control, Faculty of Infections and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Thompson', 'Affiliation': 'Nell Hodgson Woodruff School of Nursing, Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'Dana Boyd', 'Initials': 'DB', 'LastName': 'Barr', 'Affiliation': 'Department of Environmental Health, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'Maggie L', 'Initials': 'ML', 'LastName': 'Clark', 'Affiliation': 'Department of Environmental and Radiological Health Sciences, Colorado State University, Fort Collins, Colorado, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Johnson', 'Affiliation': 'Berkeley Air Monitoring Group, Berkeley, California, USA.'}, {'ForeName': 'Lance A', 'Initials': 'LA', 'LastName': 'Waller', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'Lindsay M', 'Initials': 'LM', 'LastName': 'Jaacks', 'Affiliation': 'Department of Global Health and Population, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Steenland', 'Affiliation': 'Department of Environmental Health, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'J Jaime', 'Initials': 'JJ', 'LastName': 'Miranda', 'Affiliation': 'CRONICAS Center of Excellence in Chronic Diseases, Universidad Peruana Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Howard H', 'Initials': 'HH', 'LastName': 'Chang', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'Dong-Yun', 'Initials': 'DY', 'LastName': 'Kim', 'Affiliation': 'Office of Biostatistics Research, National Heart Lung and Blood Institute, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'McCollum', 'Affiliation': 'Eudowood Division of Respiratory Sciences, Department of Pediatrics, School of Medicine, Johns Hopkins University, Baltimore, Maryland, USA.'}, {'ForeName': 'Victor G', 'Initials': 'VG', 'LastName': 'Davila-Roman', 'Affiliation': 'Cardiovascular Imaging and Clinical Research Core Laboratory, Cardiovascular Division, Washington University School of Medicine, St. Louis, Missouri, USA.'}, {'ForeName': 'Aris', 'Initials': 'A', 'LastName': 'Papageorghiou', 'Affiliation': ""Nuffield Department of Women's and Reproductive Health, University of Oxford, Oxford, UK.""}, {'ForeName': 'Joshua P', 'Initials': 'JP', 'LastName': 'Rosenthal', 'Affiliation': 'Division of Epidemiology and Population Studies, Fogarty International Center, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Environmental health perspectives,['10.1289/EHP6407']
39,32362155,Blended psychosocial support for partners of patients with ALS and PMA: results of a randomized controlled trial.,"Objective:  To evaluate whether a blended (face-to-face and online) psychosocial support program for caregivers of patients with Amyotrophic Lateral Sclerosis (ALS) and Progressive Muscular Atrophy (PMA), aimed at enhancing feeling of control over caregiving, reduces psychological distress.  Methods:  A randomized controlled trial using a wait-list control design was conducted. Caregiver-patient dyads were randomly assigned to either the support program ( n  = 74) or to a wait-list control group ( n  = 74). The support program, based on Acceptance and Commitment Therapy, consists of 1 face-to-face contact, 6 online guided modules and 1 telephone contact. Participants filled in questionnaires at baseline, 3 and 6 months. Caregivers' feeling of control over caregiving was assessed using two self-efficacy measures. Primary outcome was caregivers' psychological distress. Secondary outcomes included caregiver burden, caregiver quality of life and patients' quality of life and psychological distress. Intention-to-treat and per-protocol analyses were performed using linear mixed models.  Results:  The support program had no effect on the primary or secondary outcomes, despite a significant positive effect on the intervening variable self-efficacy with regard to control over thoughts. Almost half of the caregivers did not complete the intervention with the most frequently reported reason being lack of time. Caregivers who completed the intervention evaluated the support program positively.  Conclusions:  The support program did not reduce distress of partners of patients with ALS/PMA but may be beneficial by increasing feeling of control over the caregiving situation. The high level of intervention drop outs may have limited the ability to detect an intervention effect. Trial registration:  Netherlands Trial Registry NTR5734, registered 28 March 2016.",2020,The support program did not reduce distress of partners of patients with ALS/PMA but may be beneficial by increasing feeling of control over the caregiving situation.,"['Caregiver-patient dyads', 'caregivers of patients with Amyotrophic Lateral Sclerosis (ALS) and Progressive Muscular Atrophy (PMA', 'partners of patients with ALS and PMA']","['support program ( n \u2009=\u200974) or to a wait-list control group', 'blended (face-to-face and online) psychosocial support program', 'Blended psychosocial support']","[""caregiver burden, caregiver quality of life and patients' quality of life and psychological distress"", ""caregivers' psychological distress""]","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002736', 'cui_str': 'Amyotrophic lateral sclerosis'}, {'cui': 'C0917981', 'cui_str': 'Progressive muscular atrophy'}, {'cui': 'C0039654', 'cui_str': '12-O-Tetradecanoyl Phorbol 13-Acetate'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}]","[{'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C2958078', 'cui_str': 'Psychosocial care'}]","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}]",,0.0965384,The support program did not reduce distress of partners of patients with ALS/PMA but may be beneficial by increasing feeling of control over the caregiving situation.,"[{'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'De Wit', 'Affiliation': 'Center of Excellence for Rehabilitation Medicine, UMC Utrecht Brain Center, University Medical Center Utrecht, and De Hoogstraat Rehabilitation, Utrecht, the Netherlands.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Beelen', 'Affiliation': 'Center of Excellence for Rehabilitation Medicine, UMC Utrecht Brain Center, University Medical Center Utrecht, and De Hoogstraat Rehabilitation, Utrecht, the Netherlands.'}, {'ForeName': 'Constance H C', 'Initials': 'CHC', 'LastName': 'Drossaert', 'Affiliation': 'Department of Psychology, Health and Technology, University of Twente, Enschede, the Netherlands.'}, {'ForeName': 'Ruud', 'Initials': 'R', 'LastName': 'Kolijn', 'Affiliation': 'Patient Association ALS Patients Connected, Rotterdam the Netherlands.'}, {'ForeName': 'Leonard H', 'Initials': 'LH', 'LastName': 'Van Den Berg', 'Affiliation': 'UMC Utrecht Brain Center, Department of Neurology, University Medical Center Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Carin D', 'Initials': 'CD', 'LastName': 'SchrÖder', 'Affiliation': 'Center of Excellence for Rehabilitation Medicine, UMC Utrecht Brain Center, University Medical Center Utrecht, and De Hoogstraat Rehabilitation, Utrecht, the Netherlands.'}, {'ForeName': 'Johanna M A', 'Initials': 'JMA', 'LastName': 'Visser-Meily', 'Affiliation': 'Center of Excellence for Rehabilitation Medicine, UMC Utrecht Brain Center, University Medical Center Utrecht, and De Hoogstraat Rehabilitation, Utrecht, the Netherlands.'}]",Amyotrophic lateral sclerosis & frontotemporal degeneration,['10.1080/21678421.2020.1757114']
40,32303763,Acute Cognitive Effects of the Hypocretin Receptor Antagonist Almorexant Relative to Zolpidem and Placebo: A Randomized Clinical Trial.,"STUDY OBJECTIVES


Hypnotic medications can adversely affect behavior during unanticipated awakenings during the night. Animals treated with the hypocretin receptor antagonist almorexant (ALM) have less acute cognitive impairment compared to the GABAA receptor modulator zolpidem (ZOL). This study aimed to determine whether ALM produces less acute cognitive impairment than ZOL in human subjects.
METHODS


Healthy, young adult, unmedicated male and female subjects participated in a controlled trial of a single dose of ALM 100mg (N = 48), ALM 200mg (N = 53), ZOL 10mg (N = 49), and placebo (PBO, N = 52).
RESULTS


ZOL and both doses of ALM produced similar levels of subjective sleepiness and impaired the ability of subjects to remain awake in a dark, low stimulus setting relative to PBO. For most cognitive measures, performance under ZOL was significantly worse than ALM or PBO. For tasks involving verbal memory or visual-motor coordination, ZOL impaired performance, whereas the 2 doses of ALM were no different than PBO. For tasks involving higher order executive function, ZOL produced impairment in processing speed and inhibitory control, whereas the 2 doses of ALM were no different than PBO. Performance decrements for ALM were less than ZOL but greater than PBO for some reaction time measures.
CONCLUSION


The data provide support for the hypothesis that hypocretin receptor (Hcrt) antagonists produce less functional impairment than a benzodiazepine receptor agonist (BzRA). These observations are particularly relevant to patients treated with sedative-hypnotics who are at elevated risk for falls and other untoward events during the intended hours for sleep.",2020,"For tasks involving higher order executive function, ZOL produced impairment in processing speed and inhibitory control, whereas the 2 doses of ALM were no different than PBO.","['human subjects', 'Healthy, young adult, unmedicated male and female subjects']","['ALM', 'placebo', 'hypocretin receptor antagonist almorexant (ALM', 'Zolpidem and Placebo', 'ZOL']","['Performance decrements for ALM', 'subjective sleepiness', 'acute cognitive impairment']","[{'cui': 'C0080105', 'cui_str': 'Human Subjects'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C1871407', 'cui_str': 'almorexant'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1113688', 'cui_str': 'Orexin'}, {'cui': 'C4543207', 'cui_str': 'Receptor antagonist'}, {'cui': 'C0078839', 'cui_str': 'zolpidem'}]","[{'cui': 'C1871407', 'cui_str': 'almorexant'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}]",,0.0357918,"For tasks involving higher order executive function, ZOL produced impairment in processing speed and inhibitory control, whereas the 2 doses of ALM were no different than PBO.","[{'ForeName': 'Thomas C', 'Initials': 'TC', 'LastName': 'Neylan', 'Affiliation': 'Department of Psychiatry, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Richards', 'Affiliation': 'Department of Psychiatry, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Metzler', 'Affiliation': 'Department of Psychiatry, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Leslie M', 'Initials': 'LM', 'LastName': 'Ruoff', 'Affiliation': 'Department of Psychiatry, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Varbel', 'Affiliation': 'Department of Psychiatry, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Aoife', 'Initials': 'A', 'LastName': ""O'Donovan"", 'Affiliation': 'Department of Psychiatry, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Melinda', 'Initials': 'M', 'LastName': 'Sivasubramanian', 'Affiliation': 'Department of Psychiatry, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Terri', 'Initials': 'T', 'LastName': 'Motraghi', 'Affiliation': 'Department of Psychiatry, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Hlavin', 'Affiliation': 'Department of Psychiatry, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Steven L', 'Initials': 'SL', 'LastName': 'Batki', 'Affiliation': 'Department of Psychiatry, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Sabra S', 'Initials': 'SS', 'LastName': 'Inslicht', 'Affiliation': 'Department of Psychiatry, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Samuelson', 'Affiliation': 'Department of Psychiatry, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Morairty', 'Affiliation': 'Center for Neuroscience, Biosciences Division, SRI International, Menlo Park, CA, USA.'}, {'ForeName': 'Thomas S', 'Initials': 'TS', 'LastName': 'Kilduff', 'Affiliation': 'Center for Neuroscience, Biosciences Division, SRI International, Menlo Park, CA, USA.'}]",Sleep,['10.1093/sleep/zsaa080']
41,32372078,Follicular-phase endometrial scratching: a truncated randomized controlled trial.,"STUDY QUESTION


Does intentional endometrial injury (scratching) during the follicular phase of ovarian stimulation (OS) increase the clinical pregnancy rate (CPR) in ART?
SUMMARY ANSWER


CPR did not vary between the endometrial injury and the control group, but the trial was underpowered due to early termination because of a higher clinical miscarriage rate observed in the endometrial injury arm after a prespecified interim analysis.
WHAT IS KNOWN ALREADY


Intentional endometrial injury has been put forward as an inexpensive clinical tool capable of enhancing endometrial receptivity. However, despite its widespread use, the benefit of endometrial scratching remains controversial, with several recent randomized controlled trials (RCTs) being unable to confirm its added value. So far, most research has focused on endometrial scratching during the luteal phase of the cycle preceding the one with embryo transfer (ET), while only a few studies investigated in-cycle injury during the follicular phase of OS. Also, the persistence of a scratch effect in subsequent treatment cycles remains unclear and possible harms have been insufficiently studied.
STUDY DESIGN, SIZE, DURATION


This RCT was performed in a tertiary hospital setting between 3 April 2014 and 8 October 2017. A total of 200 women (100 per study arm) undergoing IVF/ICSI in a GnRH antagonist suppressed cycle followed by fresh ET were included.
PARTICIPANTS/MATERIALS, SETTING, METHODS


Participants were randomized with a 1:1 allocation ratio to either undergo a pipelle endometrial biopsy between Days 6 and 8 of OS or to be in the control group.The primary outcome was CPR. Secondary outcomes included biochemical pregnancy rate, live birth rate (LBR), early pregnancy loss (biochemical pregnancy losses and clinical miscarriages), excessive procedure pain/bleeding and cumulative reproductive outcomes within 6 months of the study cycle.
MAIN RESULTS AND THE ROLE OF CHANCE


The RCT was stopped prematurely by the trial team after the second prespecified interim analysis raised safety concerns, namely a higher clinical miscarriage rate in the intervention group. The intention-to-treat CPR was similar between the biopsy and the control arm (respectively, 44 versus 40%, P = 0.61, risk difference = 3.6 with 95% confidence interval = -10.1;17.3), as was the LBR (respectively, 32 versus 36%, P = 0.52). The incidence of a biochemical pregnancy loss was comparable between both groups (10% in the intervention group versus 15% in the control, P = 0.49), but clinical miscarriages occurred significantly more frequent in the biopsy group (25% versus 8%, P = 0.032). In the intervention group, 3% of the patients experienced excessive procedure pain and 5% bleeding. The cumulative LBR taking into account all conceptions (spontaneous or following ART) within 6 months of randomization was not significantly different between the biopsy and the control group (54% versus 60%, respectively, P = 0.43).
LIMITATIONS, REASONS FOR CAUTION


The trial was stopped prematurely due to safety concerns after the inclusion of 200 of the required 360 patients. Not reaching the predefined sample size implies that definite conclusions on the outcome parameters cannot be drawn. Furthermore, the pragmatic design of the study may have limited the detection of specific subgroups of women who may benefit from endometrial scratching.
WIDER IMPLICATIONS OF THE FINDINGS


Intentional endometrial injury during the follicular phase of OS warrants further attention in future research, as it may be harmful. These findings should be taken in consideration together with the growing evidence from other RCTs that scratching may not be beneficial.
STUDY FUNDING/COMPETING INTEREST(S)


This study was supported by 'Fonds Wetenschappelijk Onderzoek' (FWO, Flanders, Belgium, 11M9415N, 1524417N). None of the authors have a conflict of interest to declare with regard to this study.",2020,"Does intentional endometrial injury (scratching) during the follicular phase of ovarian stimulation (OS) increase the clinical pregnancy rate (CPR) in ART?
","['Intentional endometrial injury during the follicular phase of OS warrants', 'tertiary hospital setting between 3 April 2014 and 8 October 2017', '200 women (100 per study arm) undergoing IVF/ICSI in a GnRH antagonist suppressed cycle followed by fresh ET were included', 'Participants were randomized with a 1:1 allocation ratio to either undergo a pipelle endometrial biopsy between Days 6 and 8 of OS or to be in the control group', 'Follicular-phase endometrial scratching']",[],"['biochemical pregnancy rate, live birth rate (LBR), early pregnancy loss (biochemical pregnancy losses and clinical miscarriages), excessive procedure pain/bleeding and cumulative reproductive outcomes', 'clinical miscarriage rate', 'clinical pregnancy rate (CPR', 'LBR', 'cumulative LBR taking into account all conceptions (spontaneous or following ART', 'CPR', 'intention-to-treat CPR', 'incidence of a biochemical pregnancy loss', 'clinical miscarriages', 'excessive procedure pain and 5% bleeding']","[{'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0016434', 'cui_str': 'Menstrual Cycle, Proliferative Phase'}, {'cui': 'C0949385', 'cui_str': 'Ovarian Stimulation'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0455164', 'cui_str': 'IVF - In vitro fertilization with intracytoplasmic sperm injection (ICSI)'}, {'cui': 'C1268855', 'cui_str': 'Gonadotropin releasing hormone receptor antagonist-containing product'}, {'cui': 'C1260953', 'cui_str': 'Suppressed'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0440732', 'cui_str': 'Fresh embryo'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0441192', 'cui_str': 'Pipelle'}, {'cui': 'C0404066', 'cui_str': 'Endometrial scraping'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4049214', 'cui_str': 'Endometrial scratching'}]",[],"[{'cui': 'C0404845', 'cui_str': 'Biochemical pregnancy'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C3830362', 'cui_str': 'Early Pregnancy Loss'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C0442802', 'cui_str': 'Excessive'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0009637', 'cui_str': 'Conception'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",200.0,0.266451,"Does intentional endometrial injury (scratching) during the follicular phase of ovarian stimulation (OS) increase the clinical pregnancy rate (CPR) in ART?
","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Mackens', 'Affiliation': 'Centre for Reproductive Medicine, Universitair Ziekenhuis Brussel (UZ Brussel), Brussels, Belgium.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Racca', 'Affiliation': 'Centre for Reproductive Medicine, Universitair Ziekenhuis Brussel (UZ Brussel), Brussels, Belgium.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Van de Velde', 'Affiliation': 'Centre for Reproductive Medicine, Universitair Ziekenhuis Brussel (UZ Brussel), Brussels, Belgium.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Drakopoulos', 'Affiliation': 'Centre for Reproductive Medicine, Universitair Ziekenhuis Brussel (UZ Brussel), Brussels, Belgium.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Tournaye', 'Affiliation': 'Centre for Reproductive Medicine, Universitair Ziekenhuis Brussel (UZ Brussel), Brussels, Belgium.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Stoop', 'Affiliation': 'Centre for Reproductive Medicine, Universitair Ziekenhuis Brussel (UZ Brussel), Brussels, Belgium.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Blockeel', 'Affiliation': 'Centre for Reproductive Medicine, Universitair Ziekenhuis Brussel (UZ Brussel), Brussels, Belgium.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Santos-Ribeiro', 'Affiliation': 'Reproductive Medicine, IVI-RMA Lisboa, Avenida Infante Dom Henrique 333 H 1-9, 1800-282 Lisbon, Portugal.'}]","Human reproduction (Oxford, England)",['10.1093/humrep/deaa018']
42,32375722,Is body image a predictor of women's depression and anxiety in postmenopausal women?,"BACKGROUND


Women in perimenopausal and postmenopausal period are at increased risk of depression and anxiety. Physiologic changes in menopause can change body's appearance and function that may disturb body and then lead to anxiety and depression. This study aims to assess the relationship between body image with anxiety and depression among postmenopausal women.
METHODS


This descriptive study was performed on 307 women attending to the health centers in Tehran- Iran. Sampling was performed by a multi-staged randomized method. Data were collected by using Beck Depression questionnaire, Spielberger Anxiety Questionnaire, Fisher Body Image Questionnaire and Socio-demographic questionnaires. Data were analyzed by SPSS 21 and using t-test, Pearson and Spearman correlation tests and multiple linear regression methods.
RESULTS


The average age of the participants was 55.19 ± 4.034 years. Mean scores for body image, anxiety and depression were 163.26 ± 20.38, 12.00 ± 7.71 and 42.70 ± 8.40 respectively. Fifty five percent of women had mild to severe depression and 83.7% of them had mild to severe anxiety. Total score and all domains of body image had a negative correlation with depression and anxiety scores (P < 0.001). Multiple linear correlation showed that body image is a predictor for depression and anxiety (P < 0.001).
CONCLUSIONS


Body image of women can be effective on occurrence of depression and anxiety in menopause. Therefore, women's health policies should consider body image to control cognitive problems including depression and anxiety in menopause.",2020,Total score and all domains of body image had a negative correlation with depression and anxiety scores (P < 0.001).,"['postmenopausal women', ""women's depression and anxiety in postmenopausal women"", '307 women attending to the health centers in Tehran- Iran']",[],"['Total score', 'severe depression', 'severe anxiety', 'Mean scores for body image, anxiety and depression', 'depression and anxiety scores', 'Beck Depression questionnaire, Spielberger Anxiety Questionnaire, Fisher Body Image Questionnaire and Socio-demographic questionnaires', 'depression and anxiety']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]",[],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0588008', 'cui_str': 'Severe depression'}, {'cui': 'C0231403', 'cui_str': 'Severe anxiety (panic)'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005891', 'cui_str': 'Body image'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0325045', 'cui_str': 'Martes pennanti'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}]",307.0,0.0537412,Total score and all domains of body image had a negative correlation with depression and anxiety scores (P < 0.001).,"[{'ForeName': 'Masoumeh', 'Initials': 'M', 'LastName': 'Simbar', 'Affiliation': 'Midwifery and Reproductive Health Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Soheila', 'Initials': 'S', 'LastName': 'Nazarpour', 'Affiliation': 'Department of Midwifery, Chalous Branch, Islamic Azad University, Chalous, Iran. sn_9547@yahoo.com.'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Alavi Majd', 'Affiliation': 'Department of Biostatistics, School of Paramedicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Khadijeh', 'Initials': 'K', 'LastName': 'Dodel Andarvar', 'Affiliation': 'Department of Midwifery and Reproductive Health, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Jafari Torkamani', 'Affiliation': 'Department of Midwifery and Reproductive Health, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Alsadat Rahnemaei', 'Affiliation': 'Department of Midwifery and Reproductive Health, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",BMC psychiatry,['10.1186/s12888-020-02617-w']
43,32382082,High-risk additional chromosomal abnormalities at low blast counts herald death by CML.,"Blast crisis is one of the remaining challenges in chronic myeloid leukemia (CML). Whether additional chromosomal abnormalities (ACAs) enable an earlier recognition of imminent blastic proliferation and a timelier change of treatment is unknown. One thousand five hundred and ten imatinib-treated patients with Philadelphia-chromosome-positive (Ph+) CML randomized in CML-study IV were analyzed for ACA/Ph+ and blast increase. By impact on survival, ACAs were grouped into high risk (+8, +Ph, i(17q), +17, +19, +21, 3q26.2, 11q23, -7/7q abnormalities; complex) and low risk (all other). The presence of high- and low-risk ACAs was linked to six cohorts with different blast levels (1%, 5%, 10%, 15%, 20%, and 30%) in a Cox model. One hundred and twenty-three patients displayed ACA/Ph+ (8.1%), 91 were high risk. At low blast levels (1-15%), high-risk ACA showed an increased hazard to die compared to no ACA (ratios: 3.65 in blood; 6.12 in marrow) in contrast to low-risk ACA. No effect was observed at blast levels of 20-30%. Sixty-three patients with high-risk ACA (69%) died (n = 37) or were alive after progression or progression-related transplantation (n = 26). High-risk ACA at low blast counts identify end-phase CML earlier than current diagnostic systems. Mortality was lower with earlier treatment. Cytogenetic monitoring is indicated when signs of progression surface or response to therapy is unsatisfactory.",2020,"At low blast levels (1-15%), high-risk ACA showed an increased hazard to die compared to no ACA (ratios: 3.65 in blood; 6.12 in marrow) in contrast to low-risk ACA.","['chronic myeloid leukemia (CML', 'Sixty-three patients with high-risk ACA (69%) died (n\u2009=\u200937) or were alive after progression or progression-related transplantation (n\u2009=\u200926', 'One thousand five hundred and ten imatinib-treated patients with Philadelphia-chromosome-positive (Ph+) CML randomized in CML-study IV']",[],"['Mortality', 'survival, ACAs']","[{'cui': 'C0023473', 'cui_str': 'Chronic myeloid leukemia'}, {'cui': 'C4319614', 'cui_str': '63'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0149561', 'cui_str': 'Structure of anterior cerebral artery'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0935989', 'cui_str': 'imatinib'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0856536', 'cui_str': 'Philadelphia chromosome positive'}, {'cui': 'C0450407', 'cui_str': 'ph+'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0008625', 'cui_str': 'Abnormalities, Chromosome'}]",63.0,0.0438058,"At low blast levels (1-15%), high-risk ACA showed an increased hazard to die compared to no ACA (ratios: 3.65 in blood; 6.12 in marrow) in contrast to low-risk ACA.","[{'ForeName': 'Rüdiger', 'Initials': 'R', 'LastName': 'Hehlmann', 'Affiliation': 'ELN Foundation, Weinheim, Germany. hehlmann.eln@gmail.com.'}, {'ForeName': 'Astghik', 'Initials': 'A', 'LastName': 'Voskanyan', 'Affiliation': 'III. Medizinische Klinik, Medizinische Fakultät Mannheim, Universität Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Lauseker', 'Affiliation': 'IBE Universität München, München, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Pfirrmann', 'Affiliation': 'IBE Universität München, München, Germany.'}, {'ForeName': 'Lida', 'Initials': 'L', 'LastName': 'Kalmanti', 'Affiliation': 'III. Medizinische Klinik, Medizinische Fakultät Mannheim, Universität Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Sebastien', 'Initials': 'S', 'LastName': 'Rinaldetti', 'Affiliation': 'III. Medizinische Klinik, Medizinische Fakultät Mannheim, Universität Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Kohlbrenner', 'Affiliation': 'III. Medizinische Klinik, Medizinische Fakultät Mannheim, Universität Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Haferlach', 'Affiliation': 'MLL, München, Germany.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Schlegelberger', 'Affiliation': 'Institut für Humangenetik, MHH, Hannover, Germany.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Fabarius', 'Affiliation': 'III. Medizinische Klinik, Medizinische Fakultät Mannheim, Universität Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Seifarth', 'Affiliation': 'III. Medizinische Klinik, Medizinische Fakultät Mannheim, Universität Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Spieß', 'Affiliation': 'III. Medizinische Klinik, Medizinische Fakultät Mannheim, Universität Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Wuchter', 'Affiliation': 'Institut für Transfusionsmedizin und Immunologie, Medizinische Fakultät Mannheim, Universität Heidelberg und DRK-Blutspendedienst, Mannheim, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Krause', 'Affiliation': 'Medizinische Klinik 5, Universitätsklinikum, Erlangen, Germany.'}, {'ForeName': 'Hans-Jochem', 'Initials': 'HJ', 'LastName': 'Kolb', 'Affiliation': 'Medizinische Klinik III, Universitätsklinikum Großhadern, München, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Neubauer', 'Affiliation': 'Klinik für Innere Medizin, Universitätsklinikum, Marburg, Germany.'}, {'ForeName': 'Dieter K', 'Initials': 'DK', 'LastName': 'Hossfeld', 'Affiliation': '2. Medizinische Klinik, Universitätsklinikum Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Nerl', 'Affiliation': 'Klinikum Schwabing, München, Germany.'}, {'ForeName': 'Alois', 'Initials': 'A', 'LastName': 'Gratwohl', 'Affiliation': 'Universitätsspital, Basel, Switzerland.'}, {'ForeName': 'Gabriela M', 'Initials': 'GM', 'LastName': 'Baerlocher', 'Affiliation': 'Inselspital, Bern, Switzerland.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Burchert', 'Affiliation': 'Klinik für Innere Medizin, Universitätsklinikum, Marburg, Germany.'}, {'ForeName': 'Tim H', 'Initials': 'TH', 'LastName': 'Brümmendorf', 'Affiliation': 'Uniklinik RWTH, Aachen, Germany.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Hasford', 'Affiliation': 'IBE Universität München, München, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Hochhaus', 'Affiliation': 'Klinik für Innere Medizin II, Universitätsklinikum, Jena, Germany.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Saußele', 'Affiliation': 'III. Medizinische Klinik, Medizinische Fakultät Mannheim, Universität Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Baccarani', 'Affiliation': 'Department of Hematology-Oncology, Policlinico S.Orsola-Malpighi, University of Bologna, Bologna, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Leukemia,['10.1038/s41375-020-0826-9']
44,32380893,Optimal individualized decision rules from a multi-arm trial: A comparison of methods and an application to tailoring inter-donation intervals among blood donors in the UK.,"There is a growing interest in precision medicine where individual heterogeneity is incorporated into decision-making and treatments are tailored to individuals to provide better healthcare. One important aspect of precision medicine is the estimation of the optimal individualized treatment rule (ITR) that optimizes the expected outcome. Most methods developed for this purpose are restricted to the setting with two treatments, while clinical studies with more than two treatments are common in practice. In this work, we summarize methods to estimate the optimal ITR in the multi-arm setting and compare their performance in large-scale clinical trials via simulation studies. We then illustrate their utilities with a case study using the data from the INTERVAL trial, which randomly assigned over 20,000 male blood donors from England to one of the three inter-donation intervals (12-week, 10-week, and eight-week) over two years. We estimate the optimal individualized donation strategies under three different objectives. Our findings are fairly consistent across five different approaches that are applied: when we target the maximization of the total units of blood collected, almost all donors are assigned to the eight-week inter-donation interval, whereas if we aim at minimizing the low hemoglobin deferral rates, almost all donors are assigned to donate every 12 weeks. However, when the goal is to maximize the utility score that ""discounts"" the total units of blood collected by the incidences of low hemoglobin deferrals, we observe some heterogeneity in the optimal inter-donation interval across donors and the optimal donor assignment strategy is highly dependent on the trade-off parameter in the utility function.",2020,There is a growing interest in precision medicine where individual heterogeneity is incorporated into decision-making and treatments are tailored to individuals to provide better healthcare.,"['blood donors in the UK', '20,000 male blood donors from England to one of the three inter-donation intervals (12-week, 10-week, and eight-week) over two\u2009years']",[],[],"[{'cui': 'C0005795', 'cui_str': 'Blood donor'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C4049936', 'cui_str': 'Patient status determination, deceased and body donated'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],[],20000.0,0.0385396,There is a growing interest in precision medicine where individual heterogeneity is incorporated into decision-making and treatments are tailored to individuals to provide better healthcare.,"[{'ForeName': 'Yuejia', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'MRC Biostatistics Unit, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Angela M', 'Initials': 'AM', 'LastName': 'Wood', 'Affiliation': 'Cardiovascular Epidemiology Unit, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Sweeting', 'Affiliation': 'Cardiovascular Epidemiology Unit, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Roberts', 'Affiliation': 'BRC Haematology Theme and Radcliffe Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Brian Dm', 'Initials': 'BD', 'LastName': 'Tom', 'Affiliation': 'MRC Biostatistics Unit, University of Cambridge, Cambridge, UK.'}]",Statistical methods in medical research,['10.1177/0962280220920669']
45,32381181,Transcatheter Aortic Valve Replacement in Low-Risk Patients With Symptomatic Severe Bicuspid Aortic Valve Stenosis.,"OBJECTIVES


The aim of this study was to evaluate clinical outcomes and transcatheter heart valve hemodynamic parameters after transcatheter aortic valve replacement (TAVR) in low-risk patients with bicuspid aortic stenosis (AS).
BACKGROUND


TAVR is approved for low-risk patients in the United States. However, patients with bicuspid AS were excluded from the randomized cohorts of the pivotal low-risk trials.
METHODS


The LRT (Low Risk TAVR) trial was an investigator-initiated, prospective, multicenter study and was the first and only U.S. Food and Drug Administration-approved investigational device exemption trial to evaluate the feasibility of TAVR with either balloon-expandable or self-expanding valves in low-risk patients with bicuspid AS. The primary endpoint was all-cause mortality at 30 days. Baseline and follow-up echocardiography and computed tomography to detect leaflet thickening were analyzed in an independent core laboratory.
RESULTS


Sixty-one low-risk patients with symptomatic, severe AS and bicuspid aortic valves (78.3% Sievers type 1 morphology) underwent TAVR at 6 centers from 2016 to 2019. The mean age was 68.6 years, and 42.6% were men. At 30 days, there was zero mortality and no disabling strokes. The rate of new permanent pacemaker implantation was 13.1%; just 1 patient had a moderate paravalvular leak at 30 days. Hypoattenuated leaflet thickening was observed in 10% of patients at 30 days.
CONCLUSIONS


TAVR appears to be safe in patients with bicuspid AS, with short length of hospital stay, zero mortality, and no disabling strokes at 30 days. Subclinical leaflet thrombosis was observed in a minority of patients at 30 days but did not appear to be associated with clinical events.",2020,Subclinical leaflet thrombosis was observed in a minority of patients at 30 days but did not appear to be associated with clinical events.,"['low-risk patients in the United States', 'The mean age was 68.6 years, and 42.6% were men', 'Low-Risk Patients With Symptomatic Severe Bicuspid Aortic Valve Stenosis', 'patients with bicuspid AS', 'low-risk patients with bicuspid AS', 'low-risk patients with bicuspid aortic stenosis (AS']","['transcatheter aortic valve replacement (TAVR', 'Transcatheter Aortic Valve Replacement', 'TAVR', 'TAVR with either balloon-expandable or self-expanding valves']","['moderate paravalvular leak', 'Subclinical leaflet thrombosis', 'zero mortality and no disabling strokes', 'bicuspid aortic valves', 'cause mortality', 'rate of new permanent pacemaker implantation', 'Hypoattenuated leaflet thickening']","[{'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517855', 'cui_str': '68.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0149630', 'cui_str': 'Bicuspid aortic valve'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}, {'cui': 'C0005373', 'cui_str': 'Bicuspid'}, {'cui': 'C0003507', 'cui_str': 'Aortic valve stenosis'}]","[{'cui': 'C2711836', 'cui_str': 'Percutaneous replacement of aortic valve using fluoroscopic guidance'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205229', 'cui_str': 'Expanding'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C1709508', 'cui_str': 'Paravalvular leak'}, {'cui': 'C4552573', 'cui_str': 'Subclinical leaflet thrombosis'}, {'cui': 'C0919414', 'cui_str': '0'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0149630', 'cui_str': 'Bicuspid aortic valve'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0030163', 'cui_str': 'Cardiac pacemaker'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0205400', 'cui_str': 'Thickened'}]",,0.0590134,Subclinical leaflet thrombosis was observed in a minority of patients at 30 days but did not appear to be associated with clinical events.,"[{'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Waksman', 'Affiliation': 'Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, District of Columbia. Electronic address: ron.waksman@medstar.net.'}, {'ForeName': 'Paige E', 'Initials': 'PE', 'LastName': 'Craig', 'Affiliation': 'Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, District of Columbia.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Torguson', 'Affiliation': 'Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, District of Columbia.'}, {'ForeName': 'Federico M', 'Initials': 'FM', 'LastName': 'Asch', 'Affiliation': 'MedStar Health Research Institute, MedStar Washington Hospital Center, Washington, District of Columbia.'}, {'ForeName': 'Gaby', 'Initials': 'G', 'LastName': 'Weissman', 'Affiliation': 'Department of Cardiology, MedStar Washington Hospital Center, Washington, District of Columbia.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Ruiz', 'Affiliation': 'Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, District of Columbia.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Gordon', 'Affiliation': 'Division of Cardiology, The Miriam Hospital, Providence, Rhode Island.'}, {'ForeName': 'Afshin', 'Initials': 'A', 'LastName': 'Ehsan', 'Affiliation': 'Division of Cardiothoracic Surgery, Lifespan Cardiovascular Institute, Providence, Rhode Island.'}, {'ForeName': 'Puja', 'Initials': 'P', 'LastName': 'Parikh', 'Affiliation': 'Department of Medicine, Stony Brook Hospital, Stony Brook, New York.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bilfinger', 'Affiliation': 'Department of Surgery, Stony Brook Hospital, Stony Brook, New York.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Levitt', 'Affiliation': ""Department of Cardiology, Henrico Doctors' Hospital, Richmond, Virginia.""}, {'ForeName': 'Chiwon', 'Initials': 'C', 'LastName': 'Hahn', 'Affiliation': ""Department of Cardiothoracic Surgery, Henrico Doctors' Hospital, Richmond, Virginia.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Roberts', 'Affiliation': 'Sutter Medical Center, Sacramento, Sutter Heart and Vascular Institute, Research, Sacramento, California.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Ingram', 'Affiliation': 'Sutter Medical Center, Sacramento, Sutter Heart and Vascular Institute, Research, Sacramento, California.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Hanna', 'Affiliation': 'St. John Heart Institute Cardiovascular Consultants, St. John Health System, Tulsa, Oklahoma.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Comas', 'Affiliation': 'St. John Clinic Cardiovascular Surgery, St. John Heart Institute Cardiovascular Consultants, St. John Health System, Tulsa, Oklahoma.'}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, District of Columbia.'}, {'ForeName': 'Itsik', 'Initials': 'I', 'LastName': 'Ben-Dor', 'Affiliation': 'Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, District of Columbia.'}, {'ForeName': 'Lowell F', 'Initials': 'LF', 'LastName': 'Satler', 'Affiliation': 'Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, District of Columbia.'}, {'ForeName': 'Hector M', 'Initials': 'HM', 'LastName': 'Garcia-Garcia', 'Affiliation': 'Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, District of Columbia.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Shults', 'Affiliation': 'Department of Cardiac Surgery, MedStar Washington Hospital Center, Washington, District of Columbia.'}, {'ForeName': 'Toby', 'Initials': 'T', 'LastName': 'Rogers', 'Affiliation': 'Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, District of Columbia; Cardiovascular Branch, Division of Intramural Research, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland.'}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2020.02.008']
46,32381182,Surgery Versus TAVR for Bicuspid Aortic Valve Disease: The Time Has Come for a Randomized Study.,,2020,,['Bicuspid Aortic Valve Disease'],['Surgery Versus TAVR'],[],"[{'cui': 'C0149630', 'cui_str': 'Bicuspid aortic valve'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}]",[],,0.0169266,,"[{'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Colombo', 'Affiliation': 'GVM Care and Research, Maria Cecilia Hospital, Cotignola, Ravenna, Italy. Electronic address: ac84344@gmail.com.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Mangieri', 'Affiliation': 'GVM Care and Research, Maria Cecilia Hospital, Cotignola, Ravenna, Italy.'}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2020.02.018']
47,32381186,Thin Composite-Wire-Strut Zotarolimus-Eluting Stents Versus Ultrathin-Strut Sirolimus-Eluting Stents in BIONYX at 2 Years.,"OBJECTIVES


The aim of this study was to assess 2-year safety and efficacy of the current-generation thin composite-wire-strut durable-polymer Resolute Onyx zotarolimus-eluting stent (ZES), compared with the ultrathin-strut biodegradable-polymer Orsiro sirolimus-eluting stent (SES) in all-comers and a pre-specified small-vessel subgroup analysis.
BACKGROUND


The Resolute Onyx ZES is widely used in clinical practice, but no follow-up data beyond 1 year have been published. The randomized BIONYX (Bioresorbable Polymer-Coated Orsiro Versus Durable Polymer-Coated Resolute Onyx Stents) trial (NCT02508714) established the noninferiority of ZES versus SES regarding target vessel failure (TVF) rates.
METHODS


A total of 2,488 all-comer patients were treated at 7 coronary intervention centers in Belgium, Israel, and the Netherlands. The main endpoint, TVF, was a composite of safety (cardiac death or target vessel-related myocardial infarction) and efficacy (clinically indicated target vessel revascularization). Two-year follow-up data were analyzed using Kaplan-Meier methods.
RESULTS


Two-year follow-up data were available for 2,460 of 2,488 patients (98.9%). TVF occurred in 93 of 1,243 patients (7.6%) assigned to ZES versus 87 of 1,245 patients (7.1%) assigned to SES (log-rank p = 0.66). There was no significant between-stent difference in individual components of this endpoint. The incidence of definite-or-probable stent thrombosis was low for both treatment arms (0.4% vs. 1.1%; log-rank p = 0.057). In patients stented in small vessels, there was no between-stent difference (TVF 8.2% vs. 8.7% [log-rank p = 0.75], target lesion revascularization 4.0% vs. 4.4% [log-rank p = 0.77]).
CONCLUSIONS


At 2-year follow-up, the novel thin composite-wire-strut durable-polymer Resolute Onyx ZES showed in all-comers similar safety and efficacy compared with the ultrathin cobalt-chromium-strut biodegradable-polymer Orsiro SES. The analysis of patients who were treated in small vessels also suggested no advantage for either stent.",2020,"The main endpoint, TVF, was a composite of safety (cardiac death or target vessel-related myocardial infarction) and efficacy (clinically indicated target vessel revascularization).","['A total of 2,488 all-comer patients were treated at 7 coronary intervention centers in Belgium, Israel, and the Netherlands']","['ZES', 'Thin Composite-Wire-Strut Zotarolimus-Eluting Stents Versus Ultrathin-Strut Sirolimus-Eluting Stents', 'ultrathin-strut biodegradable-polymer Orsiro sirolimus-eluting stent (SES', 'SES', 'current-generation thin composite-wire-strut durable-polymer Resolute Onyx zotarolimus-eluting stent (ZES']","['composite of safety (cardiac death or target vessel-related myocardial infarction) and efficacy (clinically indicated target vessel revascularization', 'safety and efficacy', '2-year safety and efficacy', 'TVF', 'incidence of definite-or-probable stent thrombosis']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}, {'cui': 'C0022271', 'cui_str': 'Israel'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}]","[{'cui': 'C1700035', 'cui_str': 'Zotarolimus'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0205168', 'cui_str': 'Thin'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0005978', 'cui_str': 'Bone wire'}, {'cui': 'C0441295', 'cui_str': 'Strut'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0032521', 'cui_str': 'Polymer'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0079411', 'cui_str': 'Generations'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0449618', 'cui_str': 'Target vessel'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439544', 'cui_str': 'Definite'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}]",2488.0,0.0801469,"The main endpoint, TVF, was a composite of safety (cardiac death or target vessel-related myocardial infarction) and efficacy (clinically indicated target vessel revascularization).","[{'ForeName': 'Rosaly A', 'Initials': 'RA', 'LastName': 'Buiten', 'Affiliation': 'Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands; Department of Health Technology and Services Research, Faculty of Behavioural, Management and Social Sciences, Technical Medical Centre, University of Twente, Enschede, the Netherlands.'}, {'ForeName': 'Eline H', 'Initials': 'EH', 'LastName': 'Ploumen', 'Affiliation': 'Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands; Department of Health Technology and Services Research, Faculty of Behavioural, Management and Social Sciences, Technical Medical Centre, University of Twente, Enschede, the Netherlands.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Zocca', 'Affiliation': 'Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands.'}, {'ForeName': 'Carine J M', 'Initials': 'CJM', 'LastName': 'Doggen', 'Affiliation': 'Department of Health Technology and Services Research, Faculty of Behavioural, Management and Social Sciences, Technical Medical Centre, University of Twente, Enschede, the Netherlands.'}, {'ForeName': 'Gillian A J', 'Initials': 'GAJ', 'LastName': 'Jessurun', 'Affiliation': 'Department of Cardiology, Treant Zorggroep, Scheper Hospital, Emmen, the Netherlands.'}, {'ForeName': 'Carl E', 'Initials': 'CE', 'LastName': 'Schotborgh', 'Affiliation': 'Department of Cardiology, Haga Hospital, the Hague, the Netherlands.'}, {'ForeName': 'Ariel', 'Initials': 'A', 'LastName': 'Roguin', 'Affiliation': 'Department of Cardiology, Rambam Medical Center, Haifa, Israel.'}, {'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'Danse', 'Affiliation': 'Department of Cardiology, Rijnstate Hospital, Arnhem, the Netherlands.'}, {'ForeName': 'Edouard', 'Initials': 'E', 'LastName': 'Benit', 'Affiliation': 'Department of Cardiology, Jessa Hospital, Hasselt, Belgium.'}, {'ForeName': 'Adel', 'Initials': 'A', 'LastName': 'Aminian', 'Affiliation': 'Department of Cardiology, Centre Hospitalier Universitaire de Charleroi, Charleroi, Belgium.'}, {'ForeName': 'K Gert', 'Initials': 'KG', 'LastName': 'van Houwelingen', 'Affiliation': 'Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands.'}, {'ForeName': 'Alexander R', 'Initials': 'AR', 'LastName': 'Schramm', 'Affiliation': 'Department of Cardiology, Treant Zorggroep, Scheper Hospital, Emmen, the Netherlands.'}, {'ForeName': 'Martin G', 'Initials': 'MG', 'LastName': 'Stoel', 'Affiliation': 'Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands.'}, {'ForeName': 'Samer', 'Initials': 'S', 'LastName': 'Somi', 'Affiliation': 'Department of Cardiology, Haga Hospital, the Hague, the Netherlands.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Hartmann', 'Affiliation': 'Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands.'}, {'ForeName': 'Gerard C M', 'Initials': 'GCM', 'LastName': 'Linssen', 'Affiliation': 'Department of Cardiology, Hospital Group Twente, Almelo and Hengelo, the Netherlands.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'von Birgelen', 'Affiliation': 'Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands; Department of Health Technology and Services Research, Faculty of Behavioural, Management and Social Sciences, Technical Medical Centre, University of Twente, Enschede, the Netherlands. Electronic address: c.vonbirgelen@mst.nl.'}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2020.01.230']
48,32361414,Neural correlates of NOS1 ex1f-VNTR allelic variation in panic disorder and agoraphobia during fear conditioning and extinction in fMRI.,"Neuronal nitric oxide synthase (NOS-I) impacts on fear/anxiety-like behavior in animals. In humans, the short (S) allele of a functional promotor polymorphism of NOS1 (NOS1 ex1f-VNTR) has been shown to be associated with higher anxiety and altered fear conditioning in healthy subjects in the amygdala and hippocampus (AMY/HIPP). Here, we explore the role of NOS1 ex1f-VNTR as a pathophysiological correlate of panic disorder and agoraphobia (PD/AG). In a sub-sample of a multicenter cognitive behavioral therapy (CBT) randomized controlled trial in patients with PD/AG (n = 48: S/S-genotype n=15, S/L-genotype n=21, L/L-genotype n=12) and healthy control subjects, HS (n = 34: S/S-genotype n=7, S/L-genotype n=17, L/L-genotype=10), a differential fear conditioning and extinction fMRI-paradigm was used to investigate how NOS1 ex1f-VNTR genotypes are associated with differential neural activation in AMY/HIPP. Prior to CBT, L/L-allele carriers showed higher activation than S/S-allele carriers in AMY/HIPP. A genotype × diagnosis interaction revealed that the S-allele in HS was associated with a pronounced deactivation in AMY/HIPP, while patients showed contrary effects. The interaction of genotype × stimulus type (CS+, conditioned stimulus associated with an aversive stimulus vs. CS-, unassociated) showed effects on differential learning in AMY/HIPP. All effects were predominately found during extinction. Genotype associated effects in patients were not altered after CBT. Low statistical power due to small sample size in each subgroup is a major limitation. However, our findings provide first preliminary evidence for dysfunctional neural fear conditioning/extinction associated with NOS1 ex1f-VNTR genotype in the context of PD/AG, shedding new light on the complex interaction between genetic risk, current psychopathology and treatment-related effects.",2020,Genotype associated effects in patients were not altered after CBT.,"['n\xa0=\xa048', 'healthy subjects', 'animals', 'patients with PD/AG', 'panic disorder and agoraphobia during fear conditioning and extinction in fMRI']",['cognitive behavioral therapy (CBT'],['Neuronal nitric oxide synthase (NOS-I) impacts on fear/anxiety-like behavior'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0003062', 'cui_str': 'Kingdom Animalia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030319', 'cui_str': 'Panic disorder'}, {'cui': 'C0001818', 'cui_str': 'Agoraphobia'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0015347', 'cui_str': 'Psychological Extinction'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0669368', 'cui_str': 'Nitric Oxide Synthase, Type I'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",,0.0249077,Genotype associated effects in patients were not altered after CBT.,"[{'ForeName': 'Isabelle C', 'Initials': 'IC', 'LastName': 'Ridderbusch', 'Affiliation': 'Department of Psychiatry and Psychotherapy & Center for Mind, Brain and Behavior - CMBB, Philipps-Universität Marburg, Marburg, Germany. Electronic address: isabelle.ridderbusch@med.uni-marburg.de.'}, {'ForeName': 'Yunbo', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Psychiatry and Psychotherapy & Center for Mind, Brain and Behavior - CMBB, Philipps-Universität Marburg, Marburg, Germany.'}, {'ForeName': 'Heike', 'Initials': 'H', 'LastName': 'Weber', 'Affiliation': 'Department of Psychiatry, Psychosomatics, and Psychotherapy, University Hospital of Würzburg, Würzburg, Germany; Department of Psychiatry, Psychosomatic Medicine and Psychotherapy, University Hospital Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Reif', 'Affiliation': 'Department of Psychiatry, Psychosomatic Medicine and Psychotherapy, University Hospital Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Herterich', 'Affiliation': 'Clinical Chemistry and Laboratory Medicine, University Hospital Würzburg, Würzburg, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Ströhle', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Campus Charité Mitte, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Pfleiderer', 'Affiliation': 'Medical Faculty, University of Münster and Department Clinical Radiology, University Hospital Münster, Münster, Germany.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Arolt', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital Münster, Münster, Germany.'}, {'ForeName': 'Hans-Ulrich', 'Initials': 'HU', 'LastName': 'Wittchen', 'Affiliation': 'Institute of Clinical Psychology and Psychotherapy, Technische Universität Dresden, Dresden, Germany; Department of Psychiatry and Psychotherapy, Ludwig-Maximilians-Universität (LMU), München, Germany.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Lueken', 'Affiliation': 'Department of Psychology, Humboldt-Universität zu Berlin, Berlin, Germany.'}, {'ForeName': 'Tilo', 'Initials': 'T', 'LastName': 'Kircher', 'Affiliation': 'Department of Psychiatry and Psychotherapy & Center for Mind, Brain and Behavior - CMBB, Philipps-Universität Marburg, Marburg, Germany.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Straube', 'Affiliation': 'Department of Psychiatry and Psychotherapy & Center for Mind, Brain and Behavior - CMBB, Philipps-Universität Marburg, Marburg, Germany.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2020.102268']
49,32363918,A nurse-led intervention to promote physical activity in sedentary older adults with cardiovascular risk factors: a randomized clinical trial (STEP-IT-UP study).,"BACKGROUND


Regular physical activity should constitute the essence of treatment in patients with cardiovascular risk factors. We sought to determine the benefits of nurse-led intervention to promote physical activity in sedentary older adults in a primary care setting.
METHODS


A group of 199 sedentary older adults (mean age 62.7±6.9, 34.2% male) with at least one more cardiovascular risk factor were randomized 1:1 to receive a nurse-led tutorial on lifestyle modification, including pedometer hand-out - with a daily goal of at least 7000 steps - and supporting phone calls (study group), or without a goal or calls (control group). Body weight (BW), resting heart rate, systolic and diastolic blood pressure (SBP/DBP), total cholesterol (TC) and glucose were assessed at baseline and after 3 months.
RESULTS


Subjects in the study group ( n  = 86) achieved higher daily step count in comparison to the control group ( n  = 78), 10,648±3098 vs. 3589±2000,  p  < 0.0001. The study group presented an improvement in all analysed parameters but glucose, including BW (-2.5±1.9 kg), SBP and DBP (-7.9±7.6 mmHg and -6.2±6.5 mmHg) and TC (-14.7±30.4 mg%), all  p  < 0.0001. In the control group, all parameters increased or remained unchanged. An inverse correlation between the daily step count and delta of the analysed parameters ( r  = -0.26 to -0.72,  p  < 0.001) was found.
CONCLUSION


Nurse-led intervention with pedometer, goal setting and supporting phone calls is an effective way to promote physical activity in sedentary older adults and leads to improvement of cardiovascular risk factors within 3 months.",2020,"The study group presented an improvement in all analysed parameters but glucose, including BW (-2.5±1.9 kg), SBP and DBP (-7.9±7.6 mmHg and -6.2±6.5 mmHg) and TC (-14.7±30.4 mg%), all  p  < 0.0001.","['sedentary older adults with cardiovascular risk factors', 'sedentary older adults', 'patients with cardiovascular risk factors', 'A group of 199 sedentary older adults (mean age 62.7±6.9, 34.2% male) with at least one more cardiovascular risk factor', 'sedentary older adults in a primary care setting']","['nurse-led tutorial on lifestyle modification, including pedometer hand-out - with a daily goal of at least 7000 steps - and supporting phone calls (study group), or without a goal or calls (control group', 'nurse-led intervention']","['Body weight (BW), resting heart rate, systolic and diastolic blood pressure (SBP/DBP), total cholesterol (TC) and glucose', 'SBP and DBP', 'higher daily step count']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C5191359', 'cui_str': '34.2'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C4708914', 'cui_str': '7000'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1821417', 'cui_str': 'Resting heart rate'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439157', 'cui_str': 'counts'}]",199.0,0.023217,"The study group presented an improvement in all analysed parameters but glucose, including BW (-2.5±1.9 kg), SBP and DBP (-7.9±7.6 mmHg and -6.2±6.5 mmHg) and TC (-14.7±30.4 mg%), all  p  < 0.0001.","[{'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Chudowolska-Kiełkowska', 'Affiliation': 'Department of Nursing, University of Physical Education in Warsaw, Poland.'}, {'ForeName': 'Łukasz A', 'Initials': 'ŁA', 'LastName': 'Małek', 'Affiliation': 'Department of Epidemiology, Cardiovascular Disease Prevention and Health Promotion, National Institute of Cardiology in Warsaw, Poland.'}]",European journal of cardiovascular nursing : journal of the Working Group on Cardiovascular Nursing of the European Society of Cardiology,['10.1177/1474515120920450']
50,32363926,Using Low-Calorie Orange Juice as a Dietary Alternative to Alkali Therapy.,"Purpose:  The pursuit of a dietary source to increase urine pH and citrate in stone formers has been ongoing for >30 years. Early evidence showed that orange juice (OJ) contains alkali and citrate, but high sugar and ascorbic acid content limited the use of OJ as a viable daily source of alkali. Recently, novel low-calorie OJs have emerged and could potentially be a better option.  Methods:  Beverages with high concentrations of alkali citrate and malate were identified using ion chromatography. Two low-calorie OJ beverages, in addition to crystal light lemonade beverage (CLLB), were chosen. Healthy volunteers (5 men, 5 women) drank 1 L of OJ or CLLB with 1 L water daily for 7 days, and then completed a 24-hour urinalysis. A washout week was instituted between trial weeks. The study design is a prospective randomized crossover control trial. A paired analysis using comparison of means was used to evaluate low-calorie OJ and CLLB. Volunteers had no prior history of kidney stones and maintained a journal with beverage compliance, side effect (SE), and dietary consumption data.  Results:  Tropicana 50 (TRP50), Kroger low-calorie OJ (KLCO), and CLLB were found to have a total alkali content of 56.60, 47.9, and 17.3 mEq/L, respectively, based on ion chromatography. Consumption of all three beverages raised urinary citrate (116.6 [-118 to 373, 177.9 [-3 to 359], 155.6 [-4 to 237] ▵mg/day 95% confidence interval) and urinary pH (0.25 [0.08-0.53], 0.74 [0.41-1.07  p  < 0.05], 0.25 [0.25-0.64]), respectively, compared with water phase. Based on journal entries by volunteers, TRP50 had the most SEs (90% participants) felt to be a result of the artificial sweetener (Stevia ® ).  Conclusion:  Low-calorie OJs, and to a lesser extent CLLB, have alkali and citrate based on ion chromatography. Daily consumption by healthy volunteers of KLCO can raise urinary pH.",2020,"Based on volunteer journal entries , TRP50 had the most side effects (90% participants) felt to be a result of the artificial sweetener (Stevia ®).
","['Tropicana 50 (TRP50', 'Volunteers had no prior history of kidney stones and maintained a journal with beverage compliance, side effect, and dietary consumption data', 'Healthy volunteers (5 men, 5 women) drank 1L of OJ or CLLB with 1L water daily for 7 days and then completed a 24-hour urinalysis', 'healthy volunteers of', 'Beverages with high concentrations of alkali citrate and malate were identified using ion chromatography']","['orange juice (OJ', 'Low-calorie Orange Juice', 'KLCO']","['urinary pH', 'Kroger low calorie OJ (KLCO) and CLLB']","[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C1998388', 'cui_str': 'History of calculus of kidney'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0162443', 'cui_str': 'Journals as Topic'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0452458', 'cui_str': 'Orange juice'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0042014', 'cui_str': 'Urinalysis'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0008857', 'cui_str': 'Citrates'}, {'cui': 'C0024546', 'cui_str': 'Malates'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0022023', 'cui_str': 'Ions'}, {'cui': 'C0008550', 'cui_str': 'Chromatography'}]","[{'cui': 'C0452458', 'cui_str': 'Orange juice'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439259', 'cui_str': 'kcal'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0452458', 'cui_str': 'Orange juice'}]",2.0,0.028547,"Based on volunteer journal entries , TRP50 had the most side effects (90% participants) felt to be a result of the artificial sweetener (Stevia ®).
","[{'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Large', 'Affiliation': 'From Indiana University Department of Urology and Litholink Corporation, Laboratory Corporation of America Holdings, Indianapolis, Indiana, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Williams', 'Affiliation': 'From Indiana University Department of Urology and Litholink Corporation, Laboratory Corporation of America Holdings, Indianapolis, Indiana, USA.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Asplin', 'Affiliation': 'From Indiana University Department of Urology and Litholink Corporation, Laboratory Corporation of America Holdings, Indianapolis, Indiana, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Krambeck', 'Affiliation': 'From Indiana University Department of Urology and Litholink Corporation, Laboratory Corporation of America Holdings, Indianapolis, Indiana, USA.'}]",Journal of endourology,['10.1089/end.2020.0031']
51,32370778,"Switching to Lurasidone following 12 months of treatment with Risperidone: results of a 6-month, open-label study.","BACKGROUND


Patients with a diagnosis of schizophrenia are at an increased risk for developing metabolic syndrome, which is associated with greater cardiovascular morbidity and mortality. Treatment with some commonly used antipsychotic medications may increase the risk of developing metabolic syndrome. The aim of the study was to evaluate the safety of lurasidone in patients who continued lurasidone or switched from risperidone to lurasidone. A secondary aim was assessment of the effect of long-term lurasidone on the Positive and Negative Syndrome Scale (PANSS).
METHODS


The treatment sample in the current study consisted of clinically stable patients with schizophrenia (N = 223) who had completed a 12-month, double-blind study of lurasidone vs. risperidone. In the current extension study, all patients received 6 months of open-label treatment with lurasidone, either continuing lurasidone assigned during the preceding double-blind trial, or switching from double-blind risperidone to lurasidone. Safety and tolerability parameters included body weight, prolactin, and metabolic laboratory tests.
RESULTS


Six months of OL treatment with lurasidone was generally well-tolerated, with a low incidence of parkinsonism (4.5%) and akathisia (3.1%). Overall, few adverse events were rated as severe (4.9%), and discontinuation due to an adverse event was low in the lurasidone continuation vs. risperidone switch groups (3.7% vs. 6.9%). In the lurasidone continuation versus risperidone switch groups, change from OL baseline to 6-month endpoint (observed case) was observed in mean body weight (- 0.6 vs. -2.6 kg), median total cholesterol (- 4.0 vs. + 4.5 mg/dL), triglycerides (- 4.5 vs. -5.5 mg/dL), glucose (0.0 vs. -3.0 mg/dL) and prolactin (males, + 0.15 vs. -11.2 ng/mL; females, + 1.3 vs. -30.8 ng/mL). Improvement in PANSS total score was maintained, from OL baseline to endpoint in the continuation vs. switch groups (+ 1.0 vs. -1.0; OC).
CONCLUSIONS


In this 6-month extension study, lurasidone treatment was generally well-tolerated and associated with minimal effects on weight, metabolic parameters, and prolactin levels. Patients who switched from risperidone to lurasidone experienced reductions in weight, metabolic parameters and prolactin levels commensurate with increases in these safety parameters experienced during the previous 12 months of treatment with risperidone.
TRIAL REGISTRATION


ClinicalTrials.gov NCT00641745 (Date of Registration: March 24, 2008).",2020,"Patients who switched from risperidone to lurasidone experienced reductions in weight, metabolic parameters and prolactin levels commensurate with increases in these safety parameters experienced during the previous 12 months of treatment with risperidone.
","['patients who continued lurasidone or switched from risperidone to lurasidone', 'clinically stable patients with schizophrenia (N\u2009=\u2009223) who had completed a 12-month, double-blind study of', 'Patients with a diagnosis of schizophrenia']","['antipsychotic medications', 'risperidone to lurasidone', 'lurasidone', 'long-term lurasidone', 'lurasidone vs. risperidone', 'risperidone', 'Risperidone', 'open-label treatment with lurasidone, either continuing lurasidone']","['triglycerides', 'weight, metabolic parameters, and prolactin levels', 'Safety and tolerability parameters included body weight, prolactin, and metabolic laboratory tests', 'mean body weight', 'weight, metabolic parameters and prolactin levels', 'PANSS total score', 'Positive and Negative Syndrome Scale (PANSS', 'akathisia', 'risk of developing metabolic syndrome', 'median total cholesterol']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C2003424', 'cui_str': 'lurasidone'}, {'cui': 'C0073393', 'cui_str': 'Risperidone'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0073393', 'cui_str': 'Risperidone'}, {'cui': 'C2003424', 'cui_str': 'lurasidone'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}]","[{'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0033371', 'cui_str': 'Prolactin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392156', 'cui_str': 'Akathisia'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}]",,0.0642573,"Patients who switched from risperidone to lurasidone experienced reductions in weight, metabolic parameters and prolactin levels commensurate with increases in these safety parameters experienced during the previous 12 months of treatment with risperidone.
","[{'ForeName': 'Greg W', 'Initials': 'GW', 'LastName': 'Mattingly', 'Affiliation': 'Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Haddad', 'Affiliation': 'Hamad Medical Corporation, Doha, Qatar.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Tocco', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Fort Lee, NJ, 84 Waterford Dr, Marlborough, MA, 01752, USA. paladinmed@gmail.com.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Fort Lee, NJ, 84 Waterford Dr, Marlborough, MA, 01752, USA.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Phillips', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Fort Lee, NJ, 84 Waterford Dr, Marlborough, MA, 01752, USA.'}, {'ForeName': 'Andrei', 'Initials': 'A', 'LastName': 'Pikalov', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Fort Lee, NJ, 84 Waterford Dr, Marlborough, MA, 01752, USA.'}, {'ForeName': 'Antony', 'Initials': 'A', 'LastName': 'Loebel', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Fort Lee, NJ, 84 Waterford Dr, Marlborough, MA, 01752, USA.'}]",BMC psychiatry,['10.1186/s12888-020-02523-1']
52,32375840,Promoting parent-child relationships and preventing violence via home-visiting: a pre-post cluster randomised trial among Rwandan families linked to social protection programmes.,"BACKGROUND


Sugira Muryango is a father-engaged early child development and violence-prevention home-visiting programme delivered by trained lay workers. This cluster-randomised trial evaluates whether families living in extreme poverty (Ubudehe 1, the poorest category in the Government of Rwanda's wealth ranking) who receive Sugira Muryango in combination with a government-provided social protection programme demonstrate greater responsive, positive caregiving, nutrition, care seeking, hygiene, and father involvement compared with control families receiving usual care (UC).
METHODS


Using detailed maps, we grouped closely spaced villages into 284 geographic clusters stratified by the type of social protection programmes operating in the village clusters; 198 clusters met all enrolment criteria. Sugira Muryango was delivered to n = 541 families in 100 treatment clusters with children aged 6-36 months living in extreme poverty. We assessed changes in outcomes in intervention and n = 508 UC control families using structured surveys and observation. Analyses were intent to treat using mixed models to accommodate clustering.
RESULTS


Families receiving Sugira Muryango improved on core outcomes of parent-child relationships assessed using the Home Observation for Measurement of the Environment (Cohen's d = 0.87, 95% CI: 0.74, 0.99) and the Observation of Mother-Child Interaction (Cohen's d = 0.29, 95% CI: 0.17, 0.41). We also saw reductions in harsh discipline on items from the UNICEF MICS (OR = 0.30: 95% CI: 0.19, 0.47) and in violent victimisation of female caregivers by their partners (OR = 0.49, 95% CI: 0.24, 1.00) compared with UC. Moreover, children in families receiving SM had a 0.45 higher increase in food groups consumed in the past 24 h (Cohen's d = 0.35, 95% CI: 0.22, 0.47), increased care seeking for diarrhoea (OR = 4.43, 95% CI: 1.95, 10.10) and fever (OR = 3.28, 95% CI: 1.82, 5.89), and improved hygiene behaviours such as proper treatment of water (OR = 3.39, 95% CI: 2.16, 5.30) compared with UC. Finally, Sugira Muryango was associated with decreased caregiver depression and anxiety (OR = 0.58, 95% CI: 0.38, 0.88).
CONCLUSIONS


Sugira Muryango led to improvements in caregiver behaviours linked to child development and health as well as reductions in violence.
TRIAL REGISTRATION


ClinicalTrials.gov number NCT02510313.",2020,"RESULTS


Families receiving Sugira Muryango improved on core outcomes of parent-child relationships assessed using the Home Observation for Measurement of the Environment (Cohen's d = 0.87, 95% CI: 0.74, 0.99) and the Observation of Mother-Child Interaction (Cohen's d = 0.29, 95% CI: 0.17, 0.41).","['284 geographic clusters stratified by the type of social protection programmes operating in the village clusters; 198 clusters met all enrolment criteria', ""families living in extreme poverty (Ubudehe 1, the poorest category in the Government of Rwanda's wealth ranking) who receive"", 'Rwandan families linked to social protection programmes']","['control families receiving usual care (UC', 'Sugira Muryango in combination with a government-provided social protection programme']","['caregiver behaviours', 'hygiene behaviours', 'caregiver depression and anxiety', 'care seeking for diarrhoea', 'Observation of Mother-Child Interaction', 'fever']","[{'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0242457', 'cui_str': 'Social Protection'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0557130', 'cui_str': 'Lives with family'}, {'cui': 'C0476610', 'cui_str': 'Extreme poverty'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0018104', 'cui_str': 'Government'}, {'cui': 'C0035978', 'cui_str': 'Rwanda'}, {'cui': 'C0667477', 'cui_str': 'TNFRSF11A protein, human'}, {'cui': 'C0015576', 'cui_str': 'Family'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0018104', 'cui_str': 'Government'}, {'cui': 'C0242457', 'cui_str': 'Social Protection'}]","[{'cui': 'C1321223', 'cui_str': 'Caregiver behavior'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0026590', 'cui_str': 'Mother-Child Relationship'}, {'cui': 'C0015967', 'cui_str': 'Fever'}]",541.0,0.175466,"RESULTS


Families receiving Sugira Muryango improved on core outcomes of parent-child relationships assessed using the Home Observation for Measurement of the Environment (Cohen's d = 0.87, 95% CI: 0.74, 0.99) and the Observation of Mother-Child Interaction (Cohen's d = 0.29, 95% CI: 0.17, 0.41).","[{'ForeName': 'Theresa S', 'Initials': 'TS', 'LastName': 'Betancourt', 'Affiliation': 'Boston College School of Social Work, McGuinn Hall 106M, 140 Commonwealth Avenue, Chestnut Hill, MA, 02467, USA. theresa.betancourt@bc.edu.'}, {'ForeName': 'Sarah K G', 'Initials': 'SKG', 'LastName': 'Jensen', 'Affiliation': 'Boston College School of Social Work, McGuinn Hall 106M, 140 Commonwealth Avenue, Chestnut Hill, MA, 02467, USA.'}, {'ForeName': 'Dale A', 'Initials': 'DA', 'LastName': 'Barnhart', 'Affiliation': 'Department of Epidemiology, Harvard School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Robert T', 'Initials': 'RT', 'LastName': 'Brennan', 'Affiliation': 'Boston College School of Social Work, McGuinn Hall 106M, 140 Commonwealth Avenue, Chestnut Hill, MA, 02467, USA.'}, {'ForeName': 'Shauna M', 'Initials': 'SM', 'LastName': 'Murray', 'Affiliation': 'Boston College School of Social Work, McGuinn Hall 106M, 140 Commonwealth Avenue, Chestnut Hill, MA, 02467, USA.'}, {'ForeName': 'Aisha K', 'Initials': 'AK', 'LastName': 'Yousafzai', 'Affiliation': 'Department of Global Health and Population, Harvard School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Farrar', 'Affiliation': 'Boston College School of Social Work, McGuinn Hall 106M, 140 Commonwealth Avenue, Chestnut Hill, MA, 02467, USA.'}, {'ForeName': 'Kalisa', 'Initials': 'K', 'LastName': 'Godfroid', 'Affiliation': 'FXB Rwanda, Kigali, Rwanda.'}, {'ForeName': 'Stephanie M', 'Initials': 'SM', 'LastName': 'Bazubagira', 'Affiliation': 'FXB Rwanda, Kigali, Rwanda.'}, {'ForeName': 'Laura B', 'Initials': 'LB', 'LastName': 'Rawlings', 'Affiliation': 'The World Bank, Washington, DC, USA.'}, {'ForeName': 'Briana', 'Initials': 'B', 'LastName': 'Wilson', 'Affiliation': 'The World Bank, Washington, DC, USA.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Sezibera', 'Affiliation': 'College of Medicine and Health Sciences, University of Rwanda, Kigali, Rwanda.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Kamurase', 'Affiliation': 'The World Bank, Washington, DC, USA.'}]",BMC public health,['10.1186/s12889-020-08693-7']
53,32381030,Graphing and reporting heterogeneous treatment effects through reference classes.,"BACKGROUND


Exploration and modelling of heterogeneous treatment effects as a function of baseline covariates is an important aspect of precision medicine in randomised controlled trials (RCTs). Randomisation generally guarantees the internal validity of an RCT, but heterogeneity in treatment effect can reduce external validity. Estimation of heterogeneous treatment effects is usually done via a predictive model for individual outcomes, where one searches for interactions between treatment allocation and important patient baseline covariates. However, such models are prone to overfitting and multiple testing and typically demand a transformation of the outcome measurement, for example, from the absolute risk in the original RCT to log-odds of risk in the predictive model.
METHODS


We show how reference classes derived from baseline covariates can be used to explore heterogeneous treatment effects via a two-stage approach. We first estimate a risk score which captures on a single dimension some of the heterogeneity in outcomes of the trial population. Heterogeneity in the treatment effect can then be explored via reweighting schemes along this axis of variation. This two-stage approach bypasses the search for interactions with multiple covariates, thus protecting against multiple testing. It also allows for exploration of heterogeneous treatment effects on the original outcome scale of the RCT. This approach would typically be applied to multivariable models of baseline risk to assess the stability of average treatment effects with respect to the distribution of risk in the population studied.
CASE STUDY


We illustrate this approach using the single largest randomised treatment trial in severe falciparum malaria and demonstrate how the estimated treatment effect in terms of absolute mortality risk reduction increases considerably in higher risk strata.
CONCLUSIONS


'Local' and 'tilting' reweighting schemes based on ranking patients by baseline risk can be used as a general approach for exploring, graphing and reporting heterogeneity of treatment effect in RCTs.
TRIAL REGISTRATION


ISRCTN clinical trials registry: ISRCTN50258054. Prospectively registered on 22 July 2005.",2020,"Estimation of heterogeneous treatment effects is usually done via a predictive model for individual outcomes, where one searches for interactions between treatment allocation and important patient baseline covariates.",['Prospectively registered on 22 July 2005'],[],['external validity'],"[{'cui': 'C0600375', 'cui_str': 'Registers'}]",[],"[{'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0042283', 'cui_str': 'Validity (Epidemiology)'}]",,0.0905911,"Estimation of heterogeneous treatment effects is usually done via a predictive model for individual outcomes, where one searches for interactions between treatment allocation and important patient baseline covariates.","[{'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Watson', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, 10400, Thailand. jwatowatson@gmail.com.'}, {'ForeName': 'Chris C', 'Initials': 'CC', 'LastName': 'Holmes', 'Affiliation': 'Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, UK. cholmes@stats.ox.ac.uk.'}]",Trials,['10.1186/s13063-020-04306-1']
54,32381052,Translation of two healthy eating and active living support programs for parents of 2-6 year old children: a parallel partially randomised preference trial protocol (the 'time for healthy habits' trial).,"BACKGROUND


Parents are key decision makers and role models in establishing and maintaining healthy behaviours in their children. Interventions involving parents have been shown to be more effective than those that do not, but there are barriers to participation. Efficacy trials have previously been conducted on two such parent-focussed healthy eating and active living interventions with the potential to overcome these barriers - Healthy Habits (telephone-based) and Time2bHealthy (online) with promising results. Further research is now required to determine the effectiveness of these interventions in a real-world context. The Time for Healthy Habits study is a 3-arm partially randomised preference trial which aims to evaluate the effectiveness and cost-effectiveness of two theory-based programs to promote healthy eating and appropriate levels of movement behaviours (physical activity, sedentary behaviour and sleep) for parents of 2- to 6-year-old children (Healthy Habits Plus telephone-based program and Time2bHealthy online program), when compared to a comparison group receiving written materials.
METHODS


Participants will be recruited across five Local Health Districts in New South Wales, Australia. The partially randomised preference design initially allows for participants to decide if they wish to be randomised or opt to select their preferred intervention and has been recommended for use to test effectiveness in a real-world setting. Both interventions incorporate multiple behaviour change techniques and support parents to improve their children's healthy eating, and movement behaviours (physical activity, sedentary behaviour and sleep) and run for 12 weeks, followed by a 3-month and 9-month post-baseline follow-up. Participants will also be asked to complete a process evaluation questionnaire at the completion of the intervention (3-months post-baseline). Outcomes include fruit and vegetable intake (primary outcome), non-core food intake, weight status, physical activity, sedentary behaviour, and sleep habits.
DISCUSSION


To our knowledge, this is the first translational research trial evaluating the effectiveness and cost-effectiveness of a healthy eating and active living intervention in the 2- to 6-years age group. The results will build the evidence base in regard to translation of effective childhood obesity prevention interventions and inform the implementation and delivery of community based childhood obesity prevention programs.
TRIAL REGISTRATION


UTN: U1111-1228-9748, ACTRN: 12619000396123p.",2020,"Both interventions incorporate multiple behaviour change techniques and support parents to improve their children's healthy eating, and movement behaviours (physical activity, sedentary behaviour and sleep) and run for 12 weeks, followed by a 3-month and 9-month post-baseline follow-up.","['parents of 2- to 6-year-old children (Healthy Habits Plus', 'two healthy eating and active living support programs for parents of 2-6\u2009year old children', 'Participants will be recruited across five Local Health Districts in New South Wales, Australia']","['comparison group receiving written materials', 'healthy eating and active living intervention', 'telephone-based program and Time2bHealthy online program']","['healthy eating and appropriate levels of movement behaviours (physical activity, sedentary behaviour and sleep', 'effectiveness and cost-effectiveness', 'fruit and vegetable intake (primary outcome), non-core food intake, weight status, physical activity, sedentary behaviour, and sleep habits', ""children's healthy eating, and movement behaviours (physical activity, sedentary behaviour and sleep""]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0043015', 'cui_str': 'Wales'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C1271941', 'cui_str': 'Fruit and vegetable intake'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C2133558', 'cui_str': 'Sleep Habits'}, {'cui': 'C0686744', 'cui_str': 'Well child'}]",,0.0710845,"Both interventions incorporate multiple behaviour change techniques and support parents to improve their children's healthy eating, and movement behaviours (physical activity, sedentary behaviour and sleep) and run for 12 weeks, followed by a 3-month and 9-month post-baseline follow-up.","[{'ForeName': 'Megan L', 'Initials': 'ML', 'LastName': 'Hammersley', 'Affiliation': 'Early Start, Faculty of Social Sciences, University of Wollongong, Northfields Ave, Wollongong, NSW, 2522, Australia. mhammers@uow.edu.au.'}, {'ForeName': 'Rebecca J', 'Initials': 'RJ', 'LastName': 'Wyse', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, University Drive, Callaghan, NSW, 2308, Australia.'}, {'ForeName': 'Rachel A', 'Initials': 'RA', 'LastName': 'Jones', 'Affiliation': 'Early Start, Faculty of Social Sciences, University of Wollongong, Northfields Ave, Wollongong, NSW, 2522, Australia.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Wolfenden', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, University Drive, Callaghan, NSW, 2308, Australia.'}, {'ForeName': 'Serene', 'Initials': 'S', 'LastName': 'Yoong', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, University Drive, Callaghan, NSW, 2308, Australia.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Stacey', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, University Drive, Callaghan, NSW, 2308, Australia.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Eckermann', 'Affiliation': 'Australian Health Services Research Institute, University of Wollongong, Northfields Ave, Wollongong, NSW, 2522, Australia.'}, {'ForeName': 'Anthony D', 'Initials': 'AD', 'LastName': 'Okely', 'Affiliation': 'Early Start, Faculty of Social Sciences, University of Wollongong, Northfields Ave, Wollongong, NSW, 2522, Australia.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Innes-Hughes', 'Affiliation': 'NSW Office of Preventive Health, Liverpool Hospital, Locked Bag 7103, Liverpool BC, Sydney, NSW, Australia.'}, {'ForeName': 'Vincy', 'Initials': 'V', 'LastName': 'Li', 'Affiliation': 'NSW Office of Preventive Health, Liverpool Hospital, Locked Bag 7103, Liverpool BC, Sydney, NSW, Australia.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Green', 'Affiliation': 'NSW Office of Preventive Health, Liverpool Hospital, Locked Bag 7103, Liverpool BC, Sydney, NSW, Australia.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'May', 'Affiliation': 'Formerly Murrumbidgee Local Health District, Cootamundra Health Service, McKay St, Cootamundra, NSW, Australia.'}, {'ForeName': 'Joe', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'NSW Office of Preventive Health, Liverpool Hospital, Locked Bag 7103, Liverpool BC, Sydney, NSW, Australia.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Rissel', 'Affiliation': 'NSW Office of Preventive Health, Liverpool Hospital, Locked Bag 7103, Liverpool BC, Sydney, NSW, Australia.'}]",BMC public health,['10.1186/s12889-020-08526-7']
55,32390503,Handling missing data in modelling quality of clinician-prescribed routine care: Sensitivity analysis of departure from missing at random assumption.,"Missing information is a major drawback in analyzing data collected in many routine health care settings. Multiple imputation assuming a missing at random mechanism is a popular method to handle missing data. The missing at random assumption cannot be confirmed from the observed data alone, hence the need for sensitivity analysis to assess robustness of inference. However, sensitivity analysis is rarely conducted and reported in practice. We analyzed routine paediatric data collected during a cluster randomized trial conducted in Kenyan hospitals. We imputed missing patient and clinician-level variables assuming the missing at random mechanism. We also imputed missing clinician-level variables assuming a missing not at random mechanism. We incorporated opinions from 15 clinical experts in the form of prior distributions and shift parameters in the delta adjustment method. An interaction between trial intervention arm and follow-up time, hospital, clinician and patient-level factors were included in a proportional odds random-effects analysis model. We performed these analyses using R functions derived from the  jomo  package. Parameter estimates from multiple imputation under the missing at random mechanism were similar to multiple imputation estimates assuming the missing not at random mechanism. Our inferences were insensitive to departures from the missing at random assumption using either the prior distributions or shift parameters sensitivity analysis approach.",2020,Our inferences were insensitive to departures from the missing at random assumption using either the prior distributions or shift parameters sensitivity analysis approach.,['Kenyan hospitals'],[],[],"[{'cui': 'C0337839', 'cui_str': 'Kenyans'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]",[],[],,0.0221474,Our inferences were insensitive to departures from the missing at random assumption using either the prior distributions or shift parameters sensitivity analysis approach.,"[{'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Gachau', 'Affiliation': 'Health Services Unit, Kenya Medical Research Institute-Wellcome Trust Research Programme, Nairobi, Kenya.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Quartagno', 'Affiliation': 'Institute of Clinical Trials and Methodology, University College London, London, UK.'}, {'ForeName': 'Edmund Njeru', 'Initials': 'EN', 'LastName': 'Njagi', 'Affiliation': 'Department of Non-Communicable Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Nelson', 'Initials': 'N', 'LastName': 'Owuor', 'Affiliation': 'School of Mathematics, University of Nairobi, Nairobi, Kenya.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'English', 'Affiliation': 'Health Services Unit, Kenya Medical Research Institute-Wellcome Trust Research Programme, Nairobi, Kenya.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Ayieko', 'Affiliation': 'Department of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, UK.'}]",Statistical methods in medical research,['10.1177/0962280220918279']
56,32390092,"A randomized, controlled, two-month pilot trial of stannous fluoride dentifrice versus sodium fluoride dentifrice after oxalate treatment for dentinal hypersensitivity.","OBJECTIVES


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


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


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


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


Either stannous fluoride or sodium fluoride dentifrices can be recommended to dentinal hypersensitivity patients who undergo professional oxalate treatment.",2020,There were no significant differences between the groups at day 60.,"['dentinal hypersensitivity patients who undergo professional oxalate treatment', 'dentinal hypersensitivity', '30 subjects were professionally treated at baseline with a 3']","['stannous fluoride dentifrice', 'stannous fluoride or sodium fluoride dentifrices', 'stannous fluoride dentifrice versus sodium fluoride dentifrice', '0.454% stannous fluoride or 0.243% sodium fluoride overlabeled dentifrice', 'sodium fluoride dentifrice', 'stannous fluoride and sodium fluoride dentifrices', 'oxalate/potassium salt solution']","['Dentinal sensitivity (cold air blast challenge', 'tolerated', 'overall mean Schiff and VAS score', 'Visual Analog Scale (VAS']","[{'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0029988', 'cui_str': 'Oxalate'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]","[{'cui': 'C0038143', 'cui_str': 'Stannous Fluoride'}, {'cui': 'C0011427', 'cui_str': 'Dentifrice'}, {'cui': 'C0037508', 'cui_str': 'Sodium Fluoride'}, {'cui': 'C0029988', 'cui_str': 'Oxalate'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C3653289', 'cui_str': 'Salt solutions'}]","[{'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0450029', 'cui_str': 'Cold air'}, {'cui': 'C0337026', 'cui_str': 'Blast'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2949227', 'cui_str': 'Schiff'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",30.0,0.0592205,There were no significant differences between the groups at day 60.,"[{'ForeName': 'Chad J', 'Initials': 'CJ', 'LastName': 'Anderson', 'Affiliation': 'Department of Prosthodontics and Dental Materials, School of Dental Medicine, University of Siena, Siena, Italy. chadjanderson@sbcglobal.net.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Kugel', 'Affiliation': 'Department of Comprehensive Care, School of Dental Medicine, Tufts University, Boston, MA, USA.'}, {'ForeName': 'Yuanshu', 'Initials': 'Y', 'LastName': 'Zou', 'Affiliation': 'The Procter & Gamble Company, Mason, OH, USA.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Ferrari', 'Affiliation': 'Department of Prosthodontics and Dental Materials, School of Dental Medicine, University of Siena, Siena, Italy.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Gerlach', 'Affiliation': 'The Procter & Gamble Company, Mason, OH, USA.'}]",Clinical oral investigations,['10.1007/s00784-020-03275-8']
57,32372451,Results of feasibility and safety of randomised controlled trial of a musculoskeletal exercise intervention versus usual care for children with haemophilia.,,2020,,['children with haemophilia'],['musculoskeletal exercise intervention'],[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0019069', 'cui_str': 'Hereditary factor VIII deficiency disease'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0706649,,"[{'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Bladen', 'Affiliation': 'Great Ormond Street Hospital for Children, Heamophilia Centre, London, UK.'}, {'ForeName': 'Liz', 'Initials': 'L', 'LastName': 'Carroll', 'Affiliation': 'The Haemophilia Society, London, UK.'}, {'ForeName': 'Charlene', 'Initials': 'C', 'LastName': 'Dodd', 'Affiliation': 'Kent Thrombosis and Haemophilia Centre, Kent and Canterbury Hospital, Canterbury, UK.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Drechsler', 'Affiliation': 'Faculty of Life Sciences & Medicine, King College London, London, UK.'}, {'ForeName': 'Ferhana', 'Initials': 'F', 'LastName': 'Hashem', 'Affiliation': 'Centre for Health Service Studies, University of Kent, Canterbury, UK.'}, {'ForeName': 'Vishal', 'Initials': 'V', 'LastName': 'Patel', 'Affiliation': 'Barts Health NHS Trust, Haemophilia Centre, London, UK.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Pellatt-Higgins', 'Affiliation': 'Centre for Health Service Studies, University of Kent, Canterbury, UK.'}, {'ForeName': 'Eirini', 'Initials': 'E', 'LastName': 'Saloniki', 'Affiliation': 'Centre for Health Service Studies, University of Kent, Canterbury, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Stephensen', 'Affiliation': 'Barts Health NHS Trust, Haemophilia Centre, London, UK.'}]",Haemophilia : the official journal of the World Federation of Hemophilia,['10.1111/hae.14026']
58,32371401,Limit of detection of troponin discharge strategy versus usual care: randomised controlled trial.,"INTRODUCTION


The clinical effectiveness of a 'rule-out' acute coronary syndrome (ACS) strategy for emergency department patients with chest pain, incorporating a single undetectable high-sensitivity cardiac troponin (hs-cTn) taken at presentation, together with a non-ischaemic ECG, remains unknown.
METHODS


A randomised controlled trial, across eight hospitals in the UK, aimed to establish the clinical effectiveness of an undetectable hs-cTn and ECG (limit of detection and ECG discharge (LoDED)) discharge strategy. Eligible adult patients presented with chest pain; the treating clinician intended to perform investigations to rule out an ACS; the initial ECG was non-ischaemic; and peak symptoms occurred <6 hours previously. Participants were randomised 1:1 to either the LoDED strategy or the usual rule-out strategy. The primary outcome was discharge from the hospital within 4 hours of arrival, without a major adverse cardiac event (MACE) within 30 days.
RESULTS


Between June 2018 and March 2019, 632 patients were randomised; 3 were later withdrawn. Of 629 patients (age 53.8 (SD 16.1) years, 41% women), 7% had a MACE within 30 days. For the LoDED strategy, 141 of 309 (46%) patients were discharged within 4 hours, without MACE within 30 days, and for usual care, 114 of 311 (37%); pooled adjusted OR 1.58 (95% CI 0.84 to 2.98). No patient with an initial undetectable hs-cTn had a MACE within 30 days.
CONCLUSION


The LoDED strategy facilitates safe early discharge in >40% of patients with chest pain. Clinical effectiveness is variable when compared with existing rule-out strategies and influenced by wider system factors.
TRIAL REGISTRATION NUMBER


ISRCTN86184521.",2020,"For the LoDED strategy, 141 of 309 (46%) patients were discharged within 4 hours, without MACE within 30 days, and for usual care, 114 of 311 (37%); pooled adjusted OR 1.58 (95% CI 0.84 to 2.98).","['patients with chest pain', 'Between June 2018 and March 2019', 'Eligible adult patients presented with chest pain', 'emergency department patients with chest pain, incorporating a single undetectable high-sensitivity cardiac troponin (hs-cTn) taken at presentation, together with a non-ischaemic ECG, remains unknown', '629 patients (age 53.8 (SD 16.1) years, 41% women), 7% had a MACE within 30 days', '632 patients were randomised; 3 were later withdrawn']","['MACE', 'LoDED strategy or the usual rule-out strategy', 'troponin discharge strategy']","['clinical effectiveness of an undetectable hs-cTn and ECG (limit of detection and ECG discharge (LoDED)) discharge strategy', 'discharge from the hospital within 4\u2009hours of arrival, without a major adverse cardiac event (MACE']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008031', 'cui_str': 'Chest pain'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C1096316', 'cui_str': 'Cardiac troponin'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4319689', 'cui_str': '16.1'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C2718050', 'cui_str': 'Limits of Detection'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0041199', 'cui_str': 'Troponin'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}]","[{'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C1096316', 'cui_str': 'Cardiac troponin'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C2718050', 'cui_str': 'Limits of Detection'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1292426', 'cui_str': '4 hours'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",632.0,0.276477,"For the LoDED strategy, 141 of 309 (46%) patients were discharged within 4 hours, without MACE within 30 days, and for usual care, 114 of 311 (37%); pooled adjusted OR 1.58 (95% CI 0.84 to 2.98).","[{'ForeName': 'Edward Watts', 'Initials': 'EW', 'LastName': 'Carlton', 'Affiliation': 'Emergency Department, North Bristol NHS Trust, Bristol, UK eddcarlton@gmail.com.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Ingram', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Hazel', 'Initials': 'H', 'LastName': 'Taylor', 'Affiliation': 'Research Design Service South West, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Glynn', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Kandiyali', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Campbell', 'Affiliation': 'Peninsula Clinical Trials Unit, University of Plymouth, Plymouth, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Beasant', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Shahid', 'Initials': 'S', 'LastName': 'Aziz', 'Affiliation': 'Cardiology, North Bristol NHS Trust, Westbury on Trym, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Beresford', 'Affiliation': 'Biochemistry, North Bristol NHS Trust, Westbury on Trym, UK.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Kendall', 'Affiliation': 'Emergency Department, North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Reuben', 'Affiliation': 'Emergency Department, Royal Devon and Exeter NHS Foundation Trust, Exeter, UK.'}, {'ForeName': 'Jason E', 'Initials': 'JE', 'LastName': 'Smith', 'Affiliation': 'Emergency Department, Derriford Hospital, Plymouth, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Chapman', 'Affiliation': 'Peninsula Clinical Trials Unit, University of Plymouth, Plymouth, UK.'}, {'ForeName': 'Siobhan', 'Initials': 'S', 'LastName': 'Creanor', 'Affiliation': 'Centre for Medical Statistics, Plymouth University, Plymouth, UK.'}, {'ForeName': 'Jonathan Richard', 'Initials': 'JR', 'LastName': 'Benger', 'Affiliation': 'Academic Department of Emergency care, The University Hospitals NHS Foundation trust, Bristol, UK.'}]",Heart (British Cardiac Society),['10.1136/heartjnl-2020-316692']
59,32379216,"The effects of a new, improved Chinese medicine, Gengnianchun formula granules, on hot flushes, depression, anxiety, and sleep in Chinese peri- and postmenopausal women: a randomized placebo-controlled trial.","OBJECTIVE


The aim of the study was to investigate the effectiveness and safety of a new, improved herbal formula of a traditional Chinese medicine, improved Gengnianchun (I-GNC), on hot flushes, depression, anxiety, and sleep in peri- and postmenopausal women in China.
METHODS


A randomized, single-blind, placebo-controlled trial of peri- and postmenopausal women with Kupperman Index (KMI) scores of 15 or higher was conducted for 12 weeks. Hot flush frequencies, KMI scores, Hamilton depression scale scores, Hamilton anxiety scale scores, and Pittsburgh Sleep Quality Index scores were evaluated. Each outcome was evaluated every 4 weeks.
RESULTS


Ninety-eight participants completed the study. The I-GNC formula significantly reduced the mean (SD) frequency of hot flushes from 7 (4.554) to 1.2 (1.675) in the I-GNC group and from 6.74 (3.43) to 3.66 (2.635) in the placebo group (P < 0.01). The KMI (P < 0.01), Hamilton depression scale (P < 0.01), and Hamilton anxiety scale (P < 0.01) scores decreased in both groups after treatment, and significant differences were observed between the two groups (P < 0.01); however, no significant difference in the Pittsburgh Sleep Quality Index score was observed. I-GNC had no effect on serum follicle-stimulating hormone or E2 levels. There were no obvious adverse effects.
CONCLUSIONS


The traditional Chinese medicine herbal formula I-GNC can alleviate the symptoms of menopausal syndrome and improve quality of life among peri- and postmenopausal women. I-GNC is safe and has no notable adverse effects.",2020,"Hot flush frequencies, KMI scores, Hamilton depression scale scores, Hamilton anxiety scale scores, and Pittsburgh Sleep Quality Index scores were evaluated.","['peri- and postmenopausal women with Kupperman Index (KMI) scores of 15 or higher was conducted for 12 weeks', 'Chinese peri- and postmenopausal women', 'peri- and postmenopausal women in China', 'Ninety-eight participants completed the study', 'peri- and postmenopausal women']","['traditional Chinese medicine, improved Gengnianchun (I-GNC', 'placebo']","['quality of life', 'Hamilton anxiety scale', 'hot flushes, depression, anxiety, and sleep', 'Pittsburgh Sleep Quality Index score', 'Hamilton depression scale', 'Hot flush frequencies, KMI scores, Hamilton depression scale scores, Hamilton anxiety scale scores, and Pittsburgh Sleep Quality Index scores', 'serum follicle-stimulating hormone or E2 levels', 'mean (SD) frequency of hot flushes']","[{'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C4319627', 'cui_str': '98'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0600142', 'cui_str': 'Menopausal flushing'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C4545801', 'cui_str': 'Pittsburgh Sleep Quality Index score'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0857927', 'cui_str': 'Serum follicle stimulating hormone'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]",98.0,0.180851,"Hot flush frequencies, KMI scores, Hamilton depression scale scores, Hamilton anxiety scale scores, and Pittsburgh Sleep Quality Index scores were evaluated.","[{'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Obstetrics and Gynecology Hospital, Fudan University, Shanghai, People's Republic of China.""}, {'ForeName': 'Yuankui', 'Initials': 'Y', 'LastName': 'Cao', 'Affiliation': ''}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': ''}]","Menopause (New York, N.Y.)",['10.1097/GME.0000000000001558']
60,32375595,How mindfulness shapes the situational use of emotion regulation strategies in daily life.,"Mindfulness is associated with a wide range of beneficial outcomes such as well-being. However, less is known about the mechanisms underlying these benefits. Some researchers suggest that the benefits could be driven by emotion regulation, either by improving the effectiveness of emotion regulation or by lessening the need for effortful emotion regulation. By using two longitudinal Ambulatory Assessment data sets ( N Study1   = 125,  N Study2   = 175), based on a six-week randomised controlled trial and a one-week study, we tested these competing notions in daily life and found support for the latter: Mindfulness, and especially its non-judgmental acceptance facet, was significantly associated with less use of emotion regulation strategies. However, mindfulness was not significantly associated with more effective emotion regulation strategy implementation. Moreover, the mindfulness training focusing on present-moment attention and awareness did not significantly influence emotion regulation. These findings demonstrate the importance of the non-judgmental acceptance component for emotion regulation and affective well-being.",2020,"Mindfulness, and especially its non-judgmental acceptance facet, was significantly associated with less use of emotion regulation strategies.",[],[],['emotion regulation'],[],[],"[{'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}]",,0.0184931,"Mindfulness, and especially its non-judgmental acceptance facet, was significantly associated with less use of emotion regulation strategies.","[{'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Wenzel', 'Affiliation': 'Institute of Psychology, Johannes Gutenberg University Mainz, Mainz, Germany.'}, {'ForeName': 'Zarah', 'Initials': 'Z', 'LastName': 'Rowland', 'Affiliation': 'Institute of Psychology, Johannes Gutenberg University Mainz, Mainz, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kubiak', 'Affiliation': 'Institute of Psychology, Johannes Gutenberg University Mainz, Mainz, Germany.'}]",Cognition & emotion,['10.1080/02699931.2020.1758632']
61,32377672,Pharmacists in general practice: a qualitative process evaluation of the General Practice Pharmacist (GPP) study.,"BACKGROUND


There is some evidence to suggest that pharmacists integrated into primary care improves patient outcomes and prescribing quality. Despite this growing evidence, there is a lack of detail about the context of the role.
OBJECTIVE


To explore the implementation of The General Practice Pharmacist (GPP) intervention (pharmacists integrating into general practice within a non-randomized pilot study in Ireland), the experiences of study participants and lessons for future implementation.
DESIGN AND SETTING


Process evaluation with a descriptive qualitative approach conducted in four purposively selected GP practices.
METHODS


A process evaluation with a descriptive qualitative approach was conducted in four purposively selected GP practices. Semi-structured interviews were conducted, transcribed verbatim and analysed using a thematic analysis.
RESULTS


Twenty-three participants (three pharmacists, four GPs, four patients, four practice nurses, four practice managers and four practice administrators) were interviewed. Themes reported include day-to-day practicalities (incorporating location and space, systems and procedures and pharmacists' tasks), relationships and communication (incorporating GP/pharmacist mode of communication, mutual trust and respect, relationship with other practice staff and with patients) and role perception (incorporating shared goals, professional rewards, scope of practice and logistics).
CONCLUSIONS


Pharmacists working within the general practice team have potential to improve prescribing quality. This process evaluation found that a pharmacist joining the general practice team was well accepted by the GP and practice staff and effective interprofessional relationships were described. Patients were less clear of the overall benefits. Important barriers (such as funding, infrastructure and workload) and facilitators (such as teamwork and integration) to the intervention were identified which will be incorporated into a pilot cluster randomized controlled trial.",2020,Patients were less clear of the overall benefits.,"['Twenty-three participants (three pharmacists, four GPs, four patients, four practice nurses, four practice managers and four practice administrators) were interviewed', 'Process evaluation with a descriptive qualitative approach conducted in four purposively selected GP practices', 'Pharmacists in general practice']",['General Practice Pharmacist (GPP) intervention'],['patient outcomes and prescribing quality'],"[{'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0272302', 'cui_str': 'Gray platelet syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0401999', 'cui_str': 'Practice nurse'}, {'cui': 'C0402422', 'cui_str': 'Practice manager'}, {'cui': 'C0085751', 'cui_str': 'Administrators'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0205556', 'cui_str': 'Qualitative'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}]","[{'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0332306', 'cui_str': 'Quality'}]",23.0,0.0503933,Patients were less clear of the overall benefits.,"[{'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'James', 'Affiliation': 'HRB Centre for Primary Care Research, Department of General Practice, Royal College of Surgeons in Ireland (RCSI), 123 St. Stephens Green, Dublin 2, Republic of Ireland.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Cardwell', 'Affiliation': 'HRB Centre for Primary Care Research, Department of General Practice, Royal College of Surgeons in Ireland (RCSI), 123 St. Stephens Green, Dublin 2, Republic of Ireland.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Moriarty', 'Affiliation': 'HRB Centre for Primary Care Research, Department of General Practice, Royal College of Surgeons in Ireland (RCSI), 123 St. Stephens Green, Dublin 2, Republic of Ireland.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Smith', 'Affiliation': 'HRB Centre for Primary Care Research, Department of General Practice, Royal College of Surgeons in Ireland (RCSI), 123 St. Stephens Green, Dublin 2, Republic of Ireland.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Clyne', 'Affiliation': 'HRB Centre for Primary Care Research, Department of General Practice, Royal College of Surgeons in Ireland (RCSI), 123 St. Stephens Green, Dublin 2, Republic of Ireland.'}]",Family practice,['10.1093/fampra/cmaa044']
62,32380679,"Effect of Dynamic Balance Exercises Based on Visual Feedback on Physical Function, Balance Ability, and Depression in Women after Bilateral Total Knee Arthroplasty: A Randomized Controlled Trial.","The aim of this study was to compare the effects of dynamic balance exercises with and without visual feedback on recovery from total knee arthroplasty. The participants were 30 women who underwent total knee arthroplasty more than one week before the study, and were randomly allocated into two groups. The average ages of the experimental and control groups were 70.13 and 69.00 years, respectively. The dynamic balance exercise with visual feedback (VF) group practiced dynamic balance exercises using a laser pointer for five 30-min sessions over a 4-week period. The dynamic balance exercise without visual feedback (control) group practiced dynamic balance exercises for five 30 min sessions over a 4 week period. The following clinical measures were used for assessing physical function, balance ability, and depression. Compared with the control group, the VF group showed significant improvements in the physical performance test, Western Ontario and McMaster Universities Arthritis Index (WOMAC), confidence ellipse area (CEA), path length (PL), average velocity (AV), and Timed Up and Go test (TUG test) ( p  < 0.05). Furthermore, the VF group showed significant improvements in all post-surgery outcome measures compared with the pre-surgery values ( p  < 0.05). The above results indicated that the dynamic balance exercises based on visual feedback improved physical function and balance ability in patients following total knee arthroplasty, suggesting the need for effective rehabilitation programs for patients with total knee arthroplasty.",2020,"Compared with the control group, the VF group showed significant improvements in the physical performance test, Western Ontario and McMaster Universities Arthritis Index (WOMAC), confidence ellipse area (CEA), path length (PL), average velocity (AV), and Timed Up and Go test (TUG test) ( p  < 0.05).","['Women after Bilateral Total Knee Arthroplasty', 'total knee arthroplasty', 'participants were 30 women who underwent total knee arthroplasty more than one week before the study', 'patients with total knee arthroplasty']","['Dynamic Balance Exercises', 'dynamic balance exercise without visual feedback (control) group practiced dynamic balance exercises', 'dynamic balance exercises with and without visual feedback', 'dynamic balance exercises', 'dynamic balance exercise with visual feedback (VF) group practiced dynamic balance exercises']","['visual feedback improved physical function and balance ability', 'Physical Function, Balance Ability, and Depression', 'physical function, balance ability, and depression', 'physical performance test, Western Ontario and McMaster Universities Arthritis Index (WOMAC), confidence ellipse area (CEA), path length (PL), average velocity (AV), and Timed Up and Go test (TUG test']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0150219', 'cui_str': 'Balance exercises'}, {'cui': 'C2936181', 'cui_str': 'Visual Feedback'}, {'cui': 'C0018262', 'cui_str': 'Group Practice'}]","[{'cui': 'C2936181', 'cui_str': 'Visual Feedback'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0560184', 'cui_str': 'Ability to balance'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0003864', 'cui_str': 'Arthritis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}]",30.0,0.0218742,"Compared with the control group, the VF group showed significant improvements in the physical performance test, Western Ontario and McMaster Universities Arthritis Index (WOMAC), confidence ellipse area (CEA), path length (PL), average velocity (AV), and Timed Up and Go test (TUG test) ( p  < 0.05).","[{'ForeName': 'Ju-Yeon', 'Initials': 'JY', 'LastName': 'Lee', 'Affiliation': 'Graduate School of Physical Therapy, Sahmyook University, Seoul 01795, Korea.'}, {'ForeName': 'Jung-Hee', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Department of Physical Therapy, Andong Science College, Andong 36616, Korea.'}, {'ForeName': 'Byoung-Hee', 'Initials': 'BH', 'LastName': 'Lee', 'Affiliation': 'Department of Physical Therapy, Sahmyook University, Seoul 01795, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17093203']
63,32384056,Young People's Experience of a Long-Term Social Media-Based Intervention for First-Episode Psychosis: Qualitative Analysis.,"BACKGROUND


Digital mental health interventions present a unique opportunity to address the lack of social connection and loneliness experienced by young people with first-episode psychosis (FEP). The first generation of digital interventions, however, is associated with high attrition rates. Social media presents an opportunity to target this issue. A new generation of digital intervention has harnessed the popularity of social media to both promote engagement and foster social connectedness in youth mental health interventions. Despite their potential, little is known about how young people engage with, and experience, social media-based interventions as well as the optimal design, implementation, and management needed to ensure young people with psychosis receive benefit.
OBJECTIVE


This study aimed to explore how young people engage with, and experience, a long-term social media-based mental health intervention designed to address social functioning in individuals with FEP.
METHODS


This qualitative study was based on 12 interviews with young people who used Horyzons, a long-term social media-based mental health intervention, as part of a previous randomized controlled trial. A semistructured phenomenological interview guide with open-ended questions was used to explore young people's subjective experience of the intervention. All interviews were recorded and transcribed verbatim. Data were analyzed using interpretative phenomenological analysis.
RESULTS


A total of 4 superordinate themes emerged during the analysis including (1) shared experience as the catalyst for a cocreated social space, (2) the power of peer support, (3) an upbeat environment, and (4) experiences that interrupt being in Horyzons.
CONCLUSIONS


We found that Horyzon's therapeutic social network fostered a connection and an understanding among young people. It also aided in the creation of an embodied experience that afforded young people with FEP a sense of self-recognition and belonging over the long term. However, although we found that most young people had strong positive experiences of a social connection on Horyzons, we also found that they experienced significant barriers that could substantively interrupt their ability to use the platform. We found that social anxiety, paranoia, internalized stigma, lack of autonomy, and social protocol confusion interfered with young people's usage of the platform. From a design perspective, digital interventions are flexible and thus equipped to begin addressing these implications by providing customizable and personalized treatment options that account for varying levels of social connection and psychological need that could otherwise interrupt young people's usage of social media-based interventions.",2020,It also aided in the creation of an embodied experience that afforded young people with FEP a sense of self-recognition and belonging over the long term.,"['young people', 'young people engage with, and experience, a long-term social media-based mental health intervention designed to address social functioning in individuals with', 'young people with first-episode psychosis (FEP', '12 interviews with young people who used Horyzons, a long-term social media-based mental health intervention, as part of a previous randomized controlled trial']",['digital intervention'],"['social anxiety, paranoia, internalized stigma, lack of autonomy, and social protocol confusion']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0376649', 'cui_str': 'Addresses'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0439615', 'cui_str': 'First episode'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C1456784', 'cui_str': 'Paranoid disorder'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0332268', 'cui_str': 'Lacking'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0009676', 'cui_str': 'Confusional state'}]",12.0,0.0185373,It also aided in the creation of an embodied experience that afforded young people with FEP a sense of self-recognition and belonging over the long term.,"[{'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Valentine', 'Affiliation': 'Orygen, Parkville, Australia.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'McEnery', 'Affiliation': 'Orygen, Parkville, Australia.'}, {'ForeName': 'Shaunagh', 'Initials': 'S', 'LastName': ""O'Sullivan"", 'Affiliation': 'Orygen, Parkville, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Gleeson', 'Affiliation': 'School of Behavioural and Health Sciences, Australian Catholic University, Melbourne, Australia.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Bendall', 'Affiliation': 'Orygen, Parkville, Australia.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Alvarez-Jimenez', 'Affiliation': 'Orygen, Parkville, Australia.'}]",Journal of medical Internet research,['10.2196/17570']
64,32384905,Foot exercise plus education versus wait and see for the treatment of plantar heel pain (FEET trial): a protocol for a feasibility study.,"BACKGROUND


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


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


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


The trial protocol was prospectively registered with the Australia and New Zealand Clinical Trial Registry (ACTRN12619000987167) on 11th July 2019.",2020,"Primary outcomes will be the feasibility of conducting a full-scale randomised clinical trial (RCT), and the credibility and acceptability of the foot exercise plus education intervention.","['individuals with PHP', 'Twenty participants with PHP']","['foot exercise plus education', 'Foot exercise plus education versus wait and see', 'IFM training', 'physiotherapist and receive detailed education on self-management strategies as well as a progressive exercise program for the IFMs', 'foot exercise plus education, or (ii) brief advice']","['treatment effects, which will consist of pain, physical function, physical activity level, pain self-efficacy, perceived treatment effect, magnetic resonance and ultrasound image measurement of IFM morphology, ultrasound imaging measurement of plantar fascia thickness, IFM motor performance, foot posture, foot mobility, ankle dorsiflexion range of motion, toe flexor and plantar flexor strength/endurance', 'feasibility of conducting a full-scale randomised clinical trial (RCT), and the credibility and acceptability of the foot exercise plus education intervention']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0231786', 'cui_str': 'Plantar heel pain'}]","[{'cui': 'C0454370', 'cui_str': 'Foot exercises'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0581753', 'cui_str': 'Muscle structure of foot'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0581753', 'cui_str': 'Muscle structure of foot'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}, {'cui': 'C0549109', 'cui_str': 'Plantar fascia structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C1286219', 'cui_str': 'Mobility of foot'}, {'cui': 'C0231770', 'cui_str': 'Dorsiflexion of foot'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0040357', 'cui_str': 'Toe structure'}, {'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0454370', 'cui_str': 'Foot exercises'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",20.0,0.0820667,"Primary outcomes will be the feasibility of conducting a full-scale randomised clinical trial (RCT), and the credibility and acceptability of the foot exercise plus education intervention.","[{'ForeName': 'Melinda M', 'Initials': 'MM', 'LastName': 'Franettovich Smith', 'Affiliation': 'School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, Queensland, 4072, Australia. melinda.smith@uq.edu.au.'}, {'ForeName': 'Natalie J', 'Initials': 'NJ', 'LastName': 'Collins', 'Affiliation': 'School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, Queensland, 4072, Australia.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Mellor', 'Affiliation': 'School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, Queensland, 4072, Australia.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Grimaldi', 'Affiliation': 'School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, Queensland, 4072, Australia.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Elliott', 'Affiliation': 'Faculty of Medicine and Health and The Kolling Research Institute, The University of Sydney, Sydney, New South Wales, 2006, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Hoggarth', 'Affiliation': 'Department of Physical Therapy and Human Movement Sciences, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Kenneth A', 'Initials': 'KA', 'LastName': 'Weber Ii', 'Affiliation': 'Systems Neuroscience and Pain Lab, Division of Pain Medicine, Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Palo Alto, California, USA.'}, {'ForeName': 'Bill', 'Initials': 'B', 'LastName': 'Vicenzino', 'Affiliation': 'School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, Queensland, 4072, Australia.'}]",Journal of foot and ankle research,['10.1186/s13047-020-00384-1']
65,32335270,"The effect of acute intragastric vs. intravenous alcohol administration on inflammation markers, blood lipids and gallbladder motility in healthy men.","Ethanol intake increases plasma concentrations of triglycerides and chronic ethanol use impairs lipid metabolism and causes chronic inflammation. The gut plays an important role in metabolic handling of nutrients, including lipids, and a leaky gut associated with alcohol intake, allowing inflammatory signals to the portal vein, has been proposed to constitute a mechanism by which ethanol induces hepatic inflammation. We compared the effects of enteral and parenteral administration of ethanol on a range of circulating inflammation markers (including soluble CD163, a marker of liver macrophage activation), lipids, cholecystokinin (CCK) and fibroblast growth factor 19 (FGF19) as well as gallbladder volume. On two separate and randomized study days, we subjected healthy men (n = 12) to double-blinded intragastric ethanol infusion (IGEI) and isoethanolemic intravenous ethanol infusion (IVEI). Blood was sampled and ultrasonographic evaluation of gallbladder volume was performed at frequent intervals for 4 h after initiation of ethanol administration on both days. Little or no effects were observed on plasma levels of inflammation markers during IGEI and IVEI, respectively. Circulating levels of total, low-density lipoprotein and high-density lipoprotein cholesterol decreased after ethanol administration independently of the administration form. Triglyceride and very low-density lipoprotein (VLDL) cholesterol concentrations increased more after IGEI compared to IVEI. IVEI had no effect on plasma CCK and caused an increased gallbladder volume whereas IGEI elicited a CCK response (P < 0.0001) without affecting gallbladder volume. Circulating FGF19 concentrations decreased equally in response to both ethanol administration forms. In conclusion, by evaluating a range of circulating inflammation markers during IGEI and IVEI we were not able to detect signs of systemic low-grade inflammation originating from the presence of ethanol in the gut. IVEI increased gallbladder volume whereas IGEI increased plasma CCK (with neutral effect on gallbladder volume), increased plasma VLDL cholesterol and triglyceride concentrations; indicating that the enteral route of administration may influence ethanol's effects on lipid metabolism.",2020,"Circulating levels of total, low-density lipoprotein and high-density lipoprotein cholesterol decreased after ethanol administration independently of the administration form.","['healthy men', 'subjected healthy men (n=12) to']","['double-blinded intragastric ethanol infusion (IGEI) and isoethanolemic intravenous ethanol infusion (IVEI', 'Ethanol intake', 'acute intragastric vs. intravenous alcohol', 'ethanol']","['Triglyceride and very low-density lipoprotein (VLDL) cholesterol concentrations', 'plasma VLDL cholesterol and triglyceride concentrations', 'inflammation markers, blood lipids and gallbladder motility', 'Circulating levels of total, low-density lipoprotein and high-density lipoprotein cholesterol', 'lipid metabolism', 'plasma levels of inflammation markers', 'IVEI increased gallbladder volume whereas IGEI increased plasma CCK', 'gallbladder volume', 'Circulating FGF19 concentrations', 'plasma CCK', 'circulating inflammation markers (including soluble CD163, a marker of liver macrophage activation), lipids, cholecystokinin (CCK) and fibroblast growth factor 19 (FGF19']","[{'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0442113', 'cui_str': 'Intragastric'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]","[{'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023825', 'cui_str': 'Very low density lipoprotein'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0023826', 'cui_str': 'VLDL cholesterol'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0016976', 'cui_str': 'Gallbladder structure'}, {'cui': 'C0007608', 'cui_str': 'Motility, Cell'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0442113', 'cui_str': 'Intragastric'}, {'cui': 'C0008328', 'cui_str': 'Cholecystokinin'}, {'cui': 'C1431711', 'cui_str': 'FGF19 protein, human'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0251113', 'cui_str': 'CD163 antigen'}, {'cui': 'C0022801', 'cui_str': 'Kupffer cell'}]",,0.130521,"Circulating levels of total, low-density lipoprotein and high-density lipoprotein cholesterol decreased after ethanol administration independently of the administration form.","[{'ForeName': 'Amalie R', 'Initials': 'AR', 'LastName': 'Lanng', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark; Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Lærke S', 'Initials': 'LS', 'LastName': 'Gasbjerg', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark; Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Natasha C', 'Initials': 'NC', 'LastName': 'Bergmann', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Gillum', 'Affiliation': 'Novo Nordisk Foundation Center for Basic Metabolic Research, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jens F', 'Initials': 'JF', 'LastName': 'Rehfeld', 'Affiliation': 'Department of Clinical Biochemistry, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Mads M', 'Initials': 'MM', 'LastName': 'Helsted', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Holger J', 'Initials': 'HJ', 'LastName': 'Møller', 'Affiliation': 'Department of Clinical Biochemistry, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Grønbæk', 'Affiliation': 'Department of Hepatology and Gastroenterology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Vilsbøll', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark; Steno Diabetes Center Copenhagen, Gentofte, Copenhagen, Denmark.'}, {'ForeName': 'Filip K', 'Initials': 'FK', 'LastName': 'Knop', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark; Novo Nordisk Foundation Center for Basic Metabolic Research, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark; Steno Diabetes Center Copenhagen, Gentofte, Copenhagen, Denmark. Electronic address: filipknop@dadlnet.dk.'}]","Alcohol (Fayetteville, N.Y.)",['10.1016/j.alcohol.2020.04.006']
66,32304981,Opioid overdose reversals using naloxone in New York City by people who use opioids: Implications for public health and overdose harm reduction approaches from a qualitative study.,"BACKGROUND


Adverse reactions to naloxone, such as withdrawal symptoms and aggression, are widely recognised in the literature by pharmaceutical manufacturers and clinical practitioners as standard reactions of individuals who are physically dependent upon opioid drugs following the reversal of potentially fatal opioid overdose. This paper seeks to provide a differentiated view on reactions to naloxone that may have important implications for public health and harm reduction approaches.
METHODS


Analyses from a qualitative investigation embedded within a 5-year Randomised Controlled Trial (RCT) examined the risks and benefits of Overdose Education and Naloxone Distribution (OEND) training models (brief or extended training) in various populations of people who use opioids in New York City. The qualitative experiences (obtained through semi-structured interviews) of 46 people who use opioids and who were each involved in the delivery of naloxone, during 56 separate overdose events that occurred throughout 2016-2018, were studied. Situational analysis and inductive content analysis of interview data focused upon overdose reversals in an attempt to provide understandings of the various adverse effects associated with naloxone from their perspective. These analyses were supplemented by data sessions within the research team during which the findings obtained from situational analysis and inductive content analysis were reviewed and complemented by deductive (clinical) appraisals of the various physical and psychological effects associated with the overdose reversals.
RESULTS


People who use opioids recognise three distinct and interconnected outcomes that may follow a successful opioid overdose reversal after intramuscular or intranasal administration of naloxone. These outcomes are here termed, (i) 'rage' (describing a wide range of angry, hostile and/or aggressive outbursts), (ii) 'withdrawal symptoms,' and (iii) 'not rage, not withdrawal' (i.e., a wide range of short-lived, 'harmless' conditions (such as temporary amnesia, mild emotional outbursts, or physical discomfort) that do not include rage or withdrawal symptoms).
CONCLUSION


Physical and psychological reactions to naloxone should not be understood exclusively as a consequence of acute, opioid-related, withdrawal symptoms. The three distinct and interconnected reversal outcomes identified in this study are considered from a harm reduction policy perspective and are further framed by concepts associated with 'mediated toxicity' (i.e., harm triggered by medicine). The overall conclusion is that harm reduction training programmes that are aligned to the policy and practice of take home naloxone may be strengthened by including awareness and training in how to best respond to 'rage' associated with overdose reversal following naloxone administration by people who use opioids and other laypersons.",2020,"RESULTS


People who use opioids recognise three distinct and interconnected outcomes that may follow a successful opioid overdose reversal after intramuscular or intranasal administration of naloxone.","['46 people who use opioids and who were each involved in the delivery of naloxone, during 56 separate overdose events that occurred throughout 2016-2018, were studied', 'individuals who are physically dependent upon opioid drugs following the reversal of potentially fatal opioid overdose', 'various populations of people who use opioids in New York City']","['Overdose Education and Naloxone Distribution (OEND) training models (brief or extended training', 'naloxone']",['successful opioid overdose reversal'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0027358', 'cui_str': 'Naloxone'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0029944', 'cui_str': 'Drug overdose'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0027977', 'cui_str': 'New York City'}]","[{'cui': 'C0029944', 'cui_str': 'Drug overdose'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0027358', 'cui_str': 'Naloxone'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0231448', 'cui_str': 'Extension'}]","[{'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0029944', 'cui_str': 'Drug overdose'}]",,0.0390371,"RESULTS


People who use opioids recognise three distinct and interconnected outcomes that may follow a successful opioid overdose reversal after intramuscular or intranasal administration of naloxone.","[{'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Parkin', 'Affiliation': ""National Addiction Centre, King's College London, 4 Windsor Walk, Denmark Hill SE5 8BB, United Kingdom. Electronic address: stephen.parkin@kcl.ac.uk.""}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Neale', 'Affiliation': ""National Addiction Centre, King's College London, 4 Windsor Walk, Denmark Hill SE5 8BB, United Kingdom; Centre for Social Research in Health, University of New South Wales, Sydney, NSW 2052, Australia.""}, {'ForeName': 'Caral', 'Initials': 'C', 'LastName': 'Brown', 'Affiliation': ""National Addiction Centre, King's College London, 4 Windsor Walk, Denmark Hill SE5 8BB, United Kingdom.""}, {'ForeName': 'Aimee N C', 'Initials': 'ANC', 'LastName': 'Campbell', 'Affiliation': 'Division on Substance Use Disorders, Columbia University Medical Center and New York State Psychiatric Institute, 1051 Riverside Drive, Unit 20, New York, NY 10032, United States.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Castillo', 'Affiliation': 'Division on Substance Use Disorders, Columbia University Medical Center and New York State Psychiatric Institute, 1051 Riverside Drive, Unit 20, New York, NY 10032, United States.'}, {'ForeName': 'Jermaine D', 'Initials': 'JD', 'LastName': 'Jones', 'Affiliation': 'Division on Substance Use Disorders, Columbia University Medical Center and New York State Psychiatric Institute, 1051 Riverside Drive, Unit 20, New York, NY 10032, United States.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Strang', 'Affiliation': ""National Addiction Centre, King's College London, 4 Windsor Walk, Denmark Hill SE5 8BB, United Kingdom; South London and Maudsley NHS Foundation Trust, Maudsley Hospital, London SE5 8AZ, United Kingdom.""}, {'ForeName': 'Sandra D', 'Initials': 'SD', 'LastName': 'Comer', 'Affiliation': 'Division on Substance Use Disorders, Columbia University Medical Center and New York State Psychiatric Institute, 1051 Riverside Drive, Unit 20, New York, NY 10032, United States.'}]",The International journal on drug policy,['10.1016/j.drugpo.2020.102751']
67,31809392,Child-Adult Relationship Enhancement in Primary Care: A Randomized Trial of a Skill-Based Parent Training with Parent Mentor Adaptation.,"INTRODUCTION


Child-Adult Relationship Enhancement in Primary Care (PriCARE) is a 6-session group training designed to teach positive parenting skills. Parent engagement in such programs is a common implementation barrier. Our objectives were to (1) examine the impact of a peer mentor on attendance and stigma and (2) replicate a previous study by measuring PriCARE's impact on child behavior and parenting practices.
METHOD


Parents of 2- to -6-year-old children without specific behavior problems were randomized to mentored PriCARE (n = 50), PriCARE (n = 50), or control (n = 50). Stigma was measured at 10 weeks. Child behavior and parenting practices were measured at baseline and 10 weeks using the Eyberg Child Behavior Inventory (ECBI) and Parenting Scale (PS). Analysis of variance models were used to examine differences across groups.
RESULTS


There was no significant difference in attendance between mentored PriCARE and PriCARE arms (mean 3.80 vs 3.36 sessions, p = 0.35). Parents randomized to the mentor reported lower stigma (3.75 vs 5.04, p = 0.02). Decreases in the mean ECBI scores between 0 and 10 weeks were greater in the PriCARE arms (n = 100) compared with the control arm (n = 50), reflecting larger improvements in behavior [intensity: -7 (-2 to -13) vs 4 (-3 to 12) to p = 0.014; problem: -3 (-1 to -4) vs 1 (-1 to 3) to p = 0.007]. Scores on all PS subscales reflected greater improvements in parenting behaviors in PriCARE arms compared with control (all p < 0.04).
CONCLUSION


Adapting PriCARE with a peer mentor may decrease stigma but does not improve program attendance. PriCARE shows promise in improving behavior in preschool-aged children and increasing positive parenting practices.",2020,"Scores on all PS subscales reflected greater improvements in parenting behaviors in PriCARE arms compared with control (all p < 0.04).
","['preschool-aged children', 'Parents of 2- to -6-year-old children without specific behavior problems', 'Child-Adult Relationship Enhancement in Primary Care']","['mentored PriCARE', 'Child-Adult Relationship Enhancement in Primary Care (PriCARE', 'Skill-Based Parent Training with Parent Mentor Adaptation', 'PriCARE']","['Stigma', 'behavior [intensity', 'mean ECBI scores', 'parenting behaviors', 'Child behavior and parenting practices', 'Eyberg Child Behavior Inventory (ECBI) and Parenting Scale (PS', 'attendance']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}, {'cui': 'C0683572', 'cui_str': 'Children, Adult'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0025369', 'cui_str': 'Mentors'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0683572', 'cui_str': 'Children, Adult'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}]","[{'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008065', 'cui_str': 'Behavior, Child'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}]",,0.137357,"Scores on all PS subscales reflected greater improvements in parenting behaviors in PriCARE arms compared with control (all p < 0.04).
","[{'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Schilling', 'Affiliation': 'Departments of Pediatrics, and.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Ritter', 'Affiliation': 'Biostatistics, University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'Joanne N', 'Initials': 'JN', 'LastName': 'Wood', 'Affiliation': ""Department of Pediatrics, Children's Hospital of Philadelphia, PA.""}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Fine', 'Affiliation': 'Biostatistics, University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'Adam J', 'Initials': 'AJ', 'LastName': 'Zolotor', 'Affiliation': 'Departments of Pediatrics, and.'}]",Journal of developmental and behavioral pediatrics : JDBP,['10.1097/DBP.0000000000000759']
68,32360128,Efficacy of Cartoon Viewing Devices During Phlebotomy in Children: A Randomized Controlled Trial.,"PURPOSE


The purpose of this study was to examine the efficacy of different cartoon viewing devices during phlebotomy in children.
DESIGN


This study was a prospective, randomized controlled trial.
METHODS


The study included inpatients from the Biochemical Laboratory of a private university hospital in Turkey and was conducted between September 2017 and April 2018. A computer-based random number generator was used to randomly assign the patients into three groups (virtual reality [VR], tablet, and control) with 40 children each. Data were collected using the Wong-Baker FACES Pain Rating Scale and the Children's Fear Scale. Pain and anxiety scores were reported by children, parents, and observers in tablet and control groups. In the VR group, pain and anxiety were determined only by children's reports.
FINDINGS


According to the children reports, the VR group reported significantly less pain and anxiety than those in the tablet and control groups (P < .05).
CONCLUSIONS


The cartoon distraction performed using a VR device reduced the perception of pain and anxiety during phlebotomy in school-age children.",2020,"According to the children reports, the VR group reported significantly less pain and anxiety than those in the tablet and control groups (P ","['inpatients from the Biochemical Laboratory of a private university hospital in Turkey and was conducted between September 2017 and April 2018', 'Children', 'school-age children', 'children']","['cartoon distraction performed using a VR device', 'Cartoon Viewing Devices', 'cartoon viewing devices']","['perception of pain and anxiety', 'Pain and anxiety scores', 'pain and anxiety', ""Baker FACES Pain Rating Scale and the Children's Fear Scale""]","[{'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0033175', 'cui_str': 'Private Room'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0041400', 'cui_str': 'Turkey - country'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0007306', 'cui_str': 'Cartoons'}, {'cui': 'C0150189', 'cui_str': 'Distraction training'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0238749', 'cui_str': 'Baker, general'}, {'cui': 'C0015468', 'cui_str': 'Pain in face'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0015726', 'cui_str': 'Fear'}]",,0.0298337,"According to the children reports, the VR group reported significantly less pain and anxiety than those in the tablet and control groups (P ","[{'ForeName': 'Demet', 'Initials': 'D', 'LastName': 'İnangil', 'Affiliation': 'Fundamentals of Nursing Department, University of Health Sciences, Hamidiye Faculty of Nursing, Istanbul, Turkey. Electronic address: demet.inangil@sbu.edu.tr.'}, {'ForeName': 'Merdiye', 'Initials': 'M', 'LastName': 'Şendir', 'Affiliation': 'Fundamentals of Nursing Department, University of Health Sciences, Hamidiye Faculty of Nursing, Istanbul, Turkey.'}, {'ForeName': 'Funda', 'Initials': 'F', 'LastName': 'Büyükyılmaz', 'Affiliation': 'Fundamentals of Nursing Department, Istanbul University-Cerrahpasa Florence Nightingale Faculty of Nursing, Istanbul, Turkey.'}]",Journal of perianesthesia nursing : official journal of the American Society of PeriAnesthesia Nurses,['10.1016/j.jopan.2020.01.008']
69,32360129,The Effect of Active Warming on Postoperative Hypothermia on Body Temperature and Thermal Comfort: A Randomized Controlled Trial.,"PURPOSE


The purpose of this study was to determine the effect of active warming method in temperature control and thermal comfort in hypothermia after surgery.
DESIGN


A randomized controlled trial.
METHODS


The study sample consisted of 64 male and female postanesthesia care unit and intensive care unit neurosurgery postoperative inpatients. The experimental group was warmed using the active warming method, and the control group's routine care was continued via a cotton blanket. Patients were warmed until their tympanic body temperature reached 37°C.
FINDINGS


The time needed to adequately warm patients was approximately twice as short in those who received active warming as compared with the control group. The perception of thermal comfort was significantly higher in the first hour in patients who received the active warming method (P < .05).
CONCLUSIONS


The active warming method resulted in a shorter time to warming in hypothermia after surgery and an increase in the perception of thermal comfort and body temperature.",2020,The active warming method resulted in a shorter time to warming in hypothermia after surgery and an increase in the perception of thermal comfort and body temperature.,"['hypothermia after surgery', '64 male and female postanesthesia care unit and intensive care unit neurosurgery postoperative inpatients']",[],"['perception of thermal comfort and body temperature', 'perception of thermal comfort', 'Body Temperature and Thermal Comfort']","[{'cui': 'C0020672', 'cui_str': 'Hypothermia'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0262723', 'cui_str': 'Postanesthesia care'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0027926', 'cui_str': 'Neurosurgery'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}]",[],"[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}]",64.0,0.0882747,The active warming method resulted in a shorter time to warming in hypothermia after surgery and an increase in the perception of thermal comfort and body temperature.,"[{'ForeName': 'Aysel', 'Initials': 'A', 'LastName': 'Özsaban', 'Affiliation': 'Department of Nursing, Faculty of Health Sciences, Karadeniz Technical University, Trabzon, Turkey. Electronic address: ayselates87@gmail.com.'}, {'ForeName': 'Rengin', 'Initials': 'R', 'LastName': 'Acaroğlu', 'Affiliation': 'Department of Fundamentals of Nursing, Florence Nightingale Faculty of Nursing, İstanbul University-Cerrahpaşa, Istanbul, Turkey.'}]",Journal of perianesthesia nursing : official journal of the American Society of PeriAnesthesia Nurses,['10.1016/j.jopan.2019.12.006']
70,30862961,Differences in patient characteristics and care practices between two trials of therapeutic hypothermia.,"BACKGROUND


The Induced Hypothermia (IH) and Optimizing Cooling (OC) trials for hypoxic-ischemic encephalopathy (HIE) had similar inclusion criteria. The rate of death/moderate-severe disability differed for the subgroups treated with therapeutic hypothermia (TH) at 33.5 °C for 72 h (44% vs. 29%, unadjusted p = 0.03). We aimed to evaluate differences in patient characteristics and care practices between the trials.
METHODS


We compared pre/post-randomization characteristics and care practices between IH and OC.
RESULTS


There were 208 patients in the IH trial, 102 cooled, and 364 in the OC trial, 95 cooled to 33.5 °C for 72 h. In OC, neonates were less ill, fewer had severe HIE, and the majority were cooled prior to randomization. Differences between IH and OC were observed in the adjusted difference in the lowest PCO 2  (+3.08 mmHg, p = 0.005) and highest PO 2  (-82.7 mmHg, p < 0.001). In OC, compared to IH, the adjusted relative risk (RR) of exposure to anticonvulsant prior to randomization was decreased (RR 0.58, (0.40-0.85), p = 0.005) and there was increased risk of exposure during cooling to sedatives/analgesia (RR 1.86 (1.21-2.86), p = 0.005).
CONCLUSION


Despite similar inclusion criteria, there were differences in patient characteristics and care practices between trials. Change in care practices over time should be considered when planning future neuroprotective trials.",2019,"The rate of death/moderate-severe disability differed for the subgroups treated with therapeutic hypothermia (TH) at 33.5 °C for 72 h (44% vs. 29%, unadjusted p = 0.03).","['208 patients in the IH trial, 102 cooled, and 364 in the OC trial, 95 cooled to 33.5\u2009°C for 72\u2009h']",['Induced Hypothermia (IH) and Optimizing Cooling (OC'],"['IH and OC', 'adjusted relative risk (RR) of exposure to anticonvulsant prior to randomization', 'risk of exposure during cooling to sedatives/analgesia', 'rate of death/moderate-severe disability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020674', 'cui_str': 'Induction of hypothermia'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0020672', 'cui_str': 'Hypothermia'}]","[{'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0020672', 'cui_str': 'Hypothermia'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0003286', 'cui_str': 'Anticonvulsant'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0020592', 'cui_str': 'HYPNOTICS AND SEDATIVES'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0231170', 'cui_str': 'Disability'}]",,0.205879,"The rate of death/moderate-severe disability differed for the subgroups treated with therapeutic hypothermia (TH) at 33.5 °C for 72 h (44% vs. 29%, unadjusted p = 0.03).","[{'ForeName': 'Sonia L', 'Initials': 'SL', 'LastName': 'Bonifacio', 'Affiliation': 'Division of Neonatal and Developmental Medicine, Stanford University School of Medicine, Palo Alto, CA, USA. soniab1@stanford.edu.'}, {'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'McDonald', 'Affiliation': 'National Institute of Child Health and Human Development, Bethesda, MD, USA.'}, {'ForeName': 'Valerie Y', 'Initials': 'VY', 'LastName': 'Chock', 'Affiliation': 'Division of Neonatal and Developmental Medicine, Stanford University School of Medicine, Palo Alto, CA, USA.'}, {'ForeName': 'Courtney J', 'Initials': 'CJ', 'LastName': 'Wusthoff', 'Affiliation': 'Division of Neonatal and Developmental Medicine, Stanford University School of Medicine, Palo Alto, CA, USA.'}, {'ForeName': 'Susan R', 'Initials': 'SR', 'LastName': 'Hintz', 'Affiliation': 'Division of Neonatal and Developmental Medicine, Stanford University School of Medicine, Palo Alto, CA, USA.'}, {'ForeName': 'Abbot R', 'Initials': 'AR', 'LastName': 'Laptook', 'Affiliation': 'Department of Pediatrics, Division of Neonatology, Brown University, Providence, RI, USA.'}, {'ForeName': 'Seetha', 'Initials': 'S', 'LastName': 'Shankara', 'Affiliation': 'Wayne State University, Detroit, Michigan, USA.'}, {'ForeName': 'Krisa P', 'Initials': 'KP', 'LastName': 'Van Meurs', 'Affiliation': 'Division of Neonatal and Developmental Medicine, Stanford University School of Medicine, Palo Alto, CA, USA.'}]",Pediatric research,['10.1038/s41390-019-0371-2']
71,32395750,To trigger or not to trigger ovulation in a natural cycle for frozen embryo transfer: a randomized controlled trial.,"STUDY QUESTION


Is the clinical pregnancy rate (CPR) following a frozen embryo transfer (FET) in a natural cycle (NC) higher after spontaneous ovulation than after triggered ovulation [natural cycle frozen embryo transfer (NC-FET) versus modified NC-FET]?
SUMMARY ANSWER


The CPR did not vary significantly between the two FET preparation protocols.
WHAT IS KNOWN ALREADY


Although the use of FET is continuously increasing, the most optimal endometrial preparation protocol is still under debate. For transfer in the NC specifically, conflicting results have been reported in terms of the outcome following spontaneous or triggered ovulation.
STUDY DESIGN, SIZE, DURATION


In a tertiary hospital setting, subjects were randomized with a 1:1 allocation into two groups between January 2014 and January 2019. Patients in group A underwent an NC-FET, while in group B, a modified NC-FET was performed with a subcutaneous hCG injection to trigger ovulation. In neither group was additional luteal phase support administered. All embryos were vitrified-warmed on Day 3 and transferred on Day 4 of embryonic development. The primary outcome was CPR at 7 weeks. All patients were followed further until 10 weeks of gestation when the ongoing pregnancy rate (OPR) was defined by the observation of foetal cardiac activity on ultrasound scan. Other secondary outcomes included biochemical pregnancy rate, early pregnancy loss and the number of visits, blood samples and ultrasonographic examinations prior to FET.
PARTICIPANTS/MATERIALS, SETTING, METHODS


A total of 260 patients (130 per study arm) were randomized, of whom 12 withdrew consent after study arm allocation. A total of 3 women conceived spontaneously before initiating the study cycle and 16 did not start for personal or medical reasons. Of the 229 actually commencing monitoring for the study FET cycle, 7 patients needed to be switched to a hormonal replacement treatment protocol due to the absence of follicular development, 12 had no embryo available for transfer after warming and 37 had a spontaneous LH surge before the ovulation trigger could be administered, although they were allocated to group B. Given the above, an intention-to-treat (ITT) analysis was performed taking into account 248 patients (125 in group A and 123 in group B), as well as a per protocol (PP) analysis on a subset of 173 patients (110 in group A and 63 in group B).
MAIN RESULTS AND THE ROLE OF CHANCE


Demographic features were evenly distributed between the study groups, as were the relevant fresh and frozen ET cycle characteristics. According to the ITT analysis, the CPR and OPR in group A (33.6% and 27.2%, respectively) and group B (29.3% and 24.4%, respectively) did not vary significantly [relative risk (RR) 0.87, 95% CI (0.60;1.26), P = 0.46 and RR 0.90, 95% CI (0.59;1.37), P = 0.61, respectively]. Biochemical pregnancy rate and early pregnancy loss were also found to be not statistically significantly different between the groups. In contrast, more clinic visits and blood samplings for cycle monitoring were required in the NC-FET group (4.05 ± 1.39) compared with the modified NC-FET group (3.03 ± 1.16, P = <0.001), while the number of ultrasound scans performed were comparable (1.70 ± 0.88 in group A versus 1.62 ± 1.04 in group B). The additional PP analysis was in line with the ITT results: CPR in group A was 36.4% versus 38.1% in group B [RR 1.05, 95% CI (0.70;1.56), P = 0.82].
LIMITATIONS, REASONS FOR CAUTION


The results are limited by the high drop-out rate for the PP analysis in the modified NC-FET group as more than one-third of the subjects allocated to this group ovulated spontaneously before ovulation triggering. Nonetheless, this issue is inherent to routine clinical practice and is an important observation of an event that can only be avoided by performing a very extensive monitoring that limits the practical advantages associated with modified NC-FET. Furthermore, although this is the largest randomized controlled trial (RCT) investigating this specific research question so far, a higher sample size would allow smaller differences in clinical outcome to be detected, since currently they may be left undetected.
WIDER IMPLICATIONS OF THE FINDINGS


This RCT adds new high-quality evidence to the existing controversial literature concerning the performance of NC-FET versus modified NC-FET. Based on our results showing no statistically significant differences in clinical outcomes between the protocols, the treatment choice may be made according to the patient's and treating physician's preferences. However, the modified NC-FET strategy reduces the need for hormonal monitoring and may therefore be considered a more patient-friendly and potentially cost-effective approach.
STUDY FUNDING/COMPETING INTEREST(S)


No specific funding was available for this study. None of the authors have a conflict of interest to declare with regard to this study.
TRIAL REGISTRATION NUMBER


NCT02145819.
TRIAL REGISTRATION DATE


8 January 2014.
DATE OF FIRST PATIENT’S ENROLMENT


21 January 2014.",2020,Biochemical pregnancy rate and early pregnancy loss were also found to be not statistically significantly different between the groups.,"['’S ENROLMENT\n\n\n21 January 2014', '3 women conceived spontaneously before initiating the study cycle and 16 did not start for personal or medical reasons', '7 patients needed to be switched to a hormonal replacement treatment protocol due to the absence of follicular development, 12 had no embryo available for transfer after warming and 37 had a', '260 patients (130 per study arm']","['FET', 'triggered ovulation [natural cycle frozen embryo transfer (NC-FET) versus modified NC-FET', 'NC-FET', 'frozen embryo transfer (FET']","['clinical pregnancy rate (CPR', 'biochemical pregnancy rate, early pregnancy loss and the number of visits, blood samples and ultrasonographic examinations prior to FET', 'CPR', 'pregnancy rate (OPR', 'spontaneous LH surge', 'Biochemical pregnancy rate and early pregnancy loss', 'clinic visits and blood samplings for cycle monitoring', 'number of ultrasound scans']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0439682', 'cui_str': 'Follicular'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0013935', 'cui_str': 'Embryos'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C4517669', 'cui_str': '260'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0404110', 'cui_str': 'Frozen embryo transfer'}, {'cui': 'C0032930', 'cui_str': 'Precipitating Factors'}, {'cui': 'C0029965', 'cui_str': 'Ovulation'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0404845', 'cui_str': 'Biochemical pregnancy'}, {'cui': 'C3830362', 'cui_str': 'Early Pregnancy Loss'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0404110', 'cui_str': 'Frozen embryo transfer'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}, {'cui': 'C0005834', 'cui_str': 'Collection of blood specimen for laboratory'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}]",3.0,0.159805,Biochemical pregnancy rate and early pregnancy loss were also found to be not statistically significantly different between the groups.,"[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Mackens', 'Affiliation': 'Centre for Reproductive Medicine, Universitair Ziekenhuis Brussel (UZ Brussel), Laarbeeklaan 101, 1090 Brussels, Belgium.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Stubbe', 'Affiliation': 'Centre for Reproductive Medicine, Universitair Ziekenhuis Brussel (UZ Brussel), Laarbeeklaan 101, 1090 Brussels, Belgium.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Santos-Ribeiro', 'Affiliation': 'Valencian Institute of Infertility Reproductive Medicine Associates (IVI-RMA) Lisboa, Avenida Infante Dom Henrique 333 H 1-9, 1800-282 Lisbon, Portugal.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Van Landuyt', 'Affiliation': 'Centre for Reproductive Medicine, Universitair Ziekenhuis Brussel (UZ Brussel), Laarbeeklaan 101, 1090 Brussels, Belgium.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Racca', 'Affiliation': 'Centre for Reproductive Medicine, Universitair Ziekenhuis Brussel (UZ Brussel), Laarbeeklaan 101, 1090 Brussels, Belgium.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Roelens', 'Affiliation': 'Centre for Reproductive Medicine, Universitair Ziekenhuis Brussel (UZ Brussel), Laarbeeklaan 101, 1090 Brussels, Belgium.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Camus', 'Affiliation': 'Centre for Reproductive Medicine, Universitair Ziekenhuis Brussel (UZ Brussel), Laarbeeklaan 101, 1090 Brussels, Belgium.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'De Vos', 'Affiliation': 'Centre for Reproductive Medicine, Universitair Ziekenhuis Brussel (UZ Brussel), Laarbeeklaan 101, 1090 Brussels, Belgium.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'van de Vijver', 'Affiliation': 'Fertiliteit, AZ Sint-Jan, Ruddershove 10, 8000 Brugge, Belgium.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Tournaye', 'Affiliation': 'Centre for Reproductive Medicine, Universitair Ziekenhuis Brussel (UZ Brussel), Laarbeeklaan 101, 1090 Brussels, Belgium.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Blockeel', 'Affiliation': 'Centre for Reproductive Medicine, Universitair Ziekenhuis Brussel (UZ Brussel), Laarbeeklaan 101, 1090 Brussels, Belgium.'}]","Human reproduction (Oxford, England)",['10.1093/humrep/deaa026']
72,32329887,Aromatherapy as an adjunctive therapy for neonatal abstinence syndrome: A pilot study.,"OBJECTIVE


To determine if aromatherapy added to the current standard of care for opioid withdrawal syndrome decreases hospitali-zation and need for opioid replacement in neonates.
DESIGN


Nonblinded, randomized control trial.
SETTING


Level 4 neonatal intensive care unit (NICU).
PATIENTS AND PARTICIPANTS


Thirty eight patients met inclusion criteria of greater than or equal to 36 weeks of gestation, history of in-trauterine opioid exposure, primary diagnosis of neonatal abstinence syndrome (NAS), and parental permission to participate.
INTERVENTIONS


Infants were randomized to either a standard therapy group or a standard therapy plus aromatherapy.
MAIN OUTCOME MEASURE(S)


Duration of therapy and length of stay.
RESULTS


Our pilot study showed that the use of aromatherapy in conjunction with standard therapy reduced the duration of medica-tion treatment by 41 percent and hospital length of stay in the NICU by 36 percent.
CONCLUSIONS


The use of aromatherapy appears to help mitigate symptoms of NAS and offers to be a viable treatment modality when used with conventional therapy.",2020,The use of aromatherapy appears to help mitigate symptoms of NAS and offers to be a viable treatment modality when used with conventional therapy.,"['Thirty eight patients met inclusion criteria of greater than or equal to 36 weeks of gestation, history of in-trauterine opioid exposure, primary diagnosis of neonatal abstinence syndrome (NAS), and parental permission to participate', 'neonatal abstinence syndrome', 'Level 4 neonatal intensive care unit (NICU', 'neonates']","['standard therapy group or a standard therapy plus aromatherapy', 'Aromatherapy', 'aromatherapy']","['Duration of therapy and length of stay', 'duration of medica-tion treatment']","[{'cui': 'C0450361', 'cui_str': '38'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0439091', 'cui_str': '>='}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0332137', 'cui_str': 'Principal diagnosis'}, {'cui': 'C0027609', 'cui_str': 'Neonatal Abstinence Syndrome'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0521104', 'cui_str': 'With permission of'}, {'cui': 'C0456950', 'cui_str': 'Level 4'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}]","[{'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0376547', 'cui_str': 'Aromatherapy'}]","[{'cui': 'C0444921', 'cui_str': 'Duration of treatment'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",,0.0521965,The use of aromatherapy appears to help mitigate symptoms of NAS and offers to be a viable treatment modality when used with conventional therapy.,"[{'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Daniel', 'Affiliation': ""Clinical Assistant Professor of Pediatrics, Children's Mercy Hospitals and Clinics, Kansas City, Missouri; University of Missouri-Kansas City, School of Medicine, Kansas City, Missouri.""}, {'ForeName': 'Lesley N', 'Initials': 'LN', 'LastName': 'Davidson', 'Affiliation': 'Neonatologist, Pediatrix Medical Group of Kentucky, PSC, Lexington, Kentucky.'}, {'ForeName': 'Jennifer R', 'Initials': 'JR', 'LastName': 'Havens', 'Affiliation': 'Associate Professor of Behavioral Science, Department of Behavioral Science, College of Medicine, University of Kentucky, Lexington, Kentucky; Center on Drug and Alcohol Research, College of Medicine, University of Kentucky, Lexington, Kentucky.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Bauer', 'Affiliation': ""Professor of Pediatrics, Division of Neonatology, College of Medicine, Kentucky Children's Hospital, University of Kentucky, Lexington, Kentucky.""}, {'ForeName': 'Lori A', 'Initials': 'LA', 'LastName': 'Shook', 'Affiliation': ""Professor of Pediatrics, Division of Neonatology, College of Medicine, Kentucky Children's Hospital, University of Kentucky, Lexington, Kentucky.""}]",Journal of opioid management,['10.5055/jom.2020.0558']
73,32363592,"Effects of Alcohol Cue Reactivity on Subsequent Treatment Outcomes Among Treatment-Seeking Individuals with Alcohol Use Disorder: A Multisite Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Varenicline.","BACKGROUND


The alcohol cue reactivity paradigm is increasingly used to screen medications for the treatment of alcohol use disorder (AUD) and other substance use disorders. Yet, its prospective association with craving and naturalistic drinking outcomes in clinical trials remains unknown. This study embedded repeated human laboratory assessments of alcohol cue reactivity within the context of a randomized controlled trial to examine the effects of varenicline tartrate (Chantix ®  ), a partial agonist of α4β2 nicotinic acetylcholine receptors, on alcohol craving among treatment-seeking heavy drinkers with AUD. Our main objectives were to test whether varenicline, as compared to placebo, blunts alcohol cue-elicited craving and test whether alcohol cue reactivity observed in the human laboratory predicts subsequent alcohol craving and use during the remainder of the trial.
DESIGN AND METHODS


This double-blind, randomized, 2-site study compared the effects of varenicline (up to 2 mg/d) and placebo on responses to in vivo alcohol cue and affective picture cue exposure in the human laboratory. Forty-seven volunteers (18 females, 29 males), ages 23 to 67 years (M = 43.7, SD = 11.5), were recruited from the community via advertisements to participate in a clinical trial designed to study the effects of varenicline on alcohol use. Participants were randomized to either varenicline or placebo for 6 weeks.
RESULTS


Varenicline did not attenuate cue-induced alcohol craving relative to placebo, but craving captured during the cue reactivity paradigm significantly predicted subsequent alcohol use in real-world settings during the clinical trial. Higher craving predicted heavier alcohol use.
CONCLUSIONS


Our results are among the first to show alcohol cue-induced craving captured during a human laboratory paradigm predicts drinking outcomes in the context of a clinical trial.",2020,"RESULTS


Varenicline did not attenuate cue-induced alcohol craving relative to placebo, but craving captured during the cue reactivity paradigm significantly predicted subsequent alcohol use in real-world settings during the clinical trial.","['Forty-seven volunteers (18 females, 29 males), ages 23 to 67 years (M = 43.7, SD = 11.5', 'Treatment-Seeking Individuals with Alcohol Use Disorder', 'treatment-seeking heavy drinkers with AUD']","['Placebo', 'Alcohol Cue Reactivity', 'varenicline or placebo', 'Varenicline', 'varenicline', 'varenicline tartrate (Chantix ®  ', 'placebo']","['alcohol craving', 'cue-induced alcohol craving']","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517534', 'cui_str': '11.5'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0001969', 'cui_str': 'Alcohol intoxication'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C1711887', 'cui_str': 'Varenicline tartrate'}, {'cui': 'C1712042', 'cui_str': 'Chantix'}]","[{'cui': 'C0556385', 'cui_str': 'Craving for alcohol'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]",47.0,0.0949334,"RESULTS


Varenicline did not attenuate cue-induced alcohol craving relative to placebo, but craving captured during the cue reactivity paradigm significantly predicted subsequent alcohol use in real-world settings during the clinical trial.","[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Miranda', 'Affiliation': 'From the, Department of Psychiatry and Human Behavior, (RMJ, SSO, HTP, RW, DEF, MLR, JBF, THC, SBM, RZL), Brown University, Providence, Rhode Island, USA.'}, {'ForeName': 'Stephanie S', 'Initials': 'SS', 'LastName': ""O'Malley"", 'Affiliation': 'From the, Department of Psychiatry and Human Behavior, (RMJ, SSO, HTP, RW, DEF, MLR, JBF, THC, SBM, RZL), Brown University, Providence, Rhode Island, USA.'}, {'ForeName': 'Hayley', 'Initials': 'H', 'LastName': 'Treloar Padovano', 'Affiliation': 'From the, Department of Psychiatry and Human Behavior, (RMJ, SSO, HTP, RW, DEF, MLR, JBF, THC, SBM, RZL), Brown University, Providence, Rhode Island, USA.'}, {'ForeName': 'Ran', 'Initials': 'R', 'LastName': 'Wu', 'Affiliation': 'From the, Department of Psychiatry and Human Behavior, (RMJ, SSO, HTP, RW, DEF, MLR, JBF, THC, SBM, RZL), Brown University, Providence, Rhode Island, USA.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Falk', 'Affiliation': 'From the, Department of Psychiatry and Human Behavior, (RMJ, SSO, HTP, RW, DEF, MLR, JBF, THC, SBM, RZL), Brown University, Providence, Rhode Island, USA.'}, {'ForeName': 'Megan L', 'Initials': 'ML', 'LastName': 'Ryan', 'Affiliation': 'From the, Department of Psychiatry and Human Behavior, (RMJ, SSO, HTP, RW, DEF, MLR, JBF, THC, SBM, RZL), Brown University, Providence, Rhode Island, USA.'}, {'ForeName': 'Joanne B', 'Initials': 'JB', 'LastName': 'Fertig', 'Affiliation': 'From the, Department of Psychiatry and Human Behavior, (RMJ, SSO, HTP, RW, DEF, MLR, JBF, THC, SBM, RZL), Brown University, Providence, Rhode Island, USA.'}, {'ForeName': 'Thomas H', 'Initials': 'TH', 'LastName': 'Chun', 'Affiliation': 'From the, Department of Psychiatry and Human Behavior, (RMJ, SSO, HTP, RW, DEF, MLR, JBF, THC, SBM, RZL), Brown University, Providence, Rhode Island, USA.'}, {'ForeName': 'Srinivas B', 'Initials': 'SB', 'LastName': 'Muvvala', 'Affiliation': 'From the, Department of Psychiatry and Human Behavior, (RMJ, SSO, HTP, RW, DEF, MLR, JBF, THC, SBM, RZL), Brown University, Providence, Rhode Island, USA.'}, {'ForeName': 'Raye Z', 'Initials': 'RZ', 'LastName': 'Litten', 'Affiliation': 'From the, Department of Psychiatry and Human Behavior, (RMJ, SSO, HTP, RW, DEF, MLR, JBF, THC, SBM, RZL), Brown University, Providence, Rhode Island, USA.'}]","Alcoholism, clinical and experimental research",['10.1111/acer.14352']
74,32372277,Preventive effect of low-dose landiolol on postoperative atrial fibrillation study (PELTA study).,"OBJECTIVE


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


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


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


These findings indicate that prophylactic administration of low-dose landiolol may not be effective for preventing the occurrence of POAF in overall patients after cardiovascular surgery, but the administration could be beneficial to female patients, patients not using ARBs preoperatively, and those after valvular surgery.",2020,"Subgroup analysis showed a significant dose-dependent reduction in POAF among categories of female sex, non-use of angiotensin II receptor blockers (ARBs) before surgery, and valve surgery (each trend-p = 0.02, 0.03, and 0.004).
","['patients after cardiovascular surgery', 'Consecutive', '150 patients over 70\xa0years of age who underwent cardiovascular surgery for valvular, ischemic heart, and aortic diseases were enrolled in this single-center prospective randomized control study from 2010 to 2014']","['Electrocardiography', '1γ group (landiolol at 1\xa0μg/kg/min), 2γ group (landiolol at 2\xa0μg/kg/min), or control group (no landiolol', 'landiolol hydrochloride', 'low-dose landiolol']","['postoperative atrial fibrillation (POAF', 'POAF']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038897', 'cui_str': 'Cardiovascular surgical procedure'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0003493', 'cui_str': 'Disorder of aorta'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0905464', 'cui_str': 'landiolol'}, {'cui': 'C1532757', 'cui_str': 'kg/min'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}]",,0.097828,"Subgroup analysis showed a significant dose-dependent reduction in POAF among categories of female sex, non-use of angiotensin II receptor blockers (ARBs) before surgery, and valve surgery (each trend-p = 0.02, 0.03, and 0.004).
","[{'ForeName': 'Konosuke', 'Initials': 'K', 'LastName': 'Sasaki', 'Affiliation': 'Division of Cardiovascular Surgery, Tohoku University Graduate School of Medicine, 1-1 Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan.'}, {'ForeName': 'Kiichiro', 'Initials': 'K', 'LastName': 'Kumagai', 'Affiliation': 'Research Division of Sciences for Aortic Disease, Tohoku University Graduate School of Medicine, Sendai, Japan.'}, {'ForeName': 'Kay', 'Initials': 'K', 'LastName': 'Maeda', 'Affiliation': 'Division of Cardiovascular Surgery, Tohoku University Graduate School of Medicine, 1-1 Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan.'}, {'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Akiyama', 'Affiliation': 'Division of Cardiovascular Surgery, Tohoku University Graduate School of Medicine, 1-1 Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan.'}, {'ForeName': 'Koki', 'Initials': 'K', 'LastName': 'Ito', 'Affiliation': 'Division of Cardiovascular Surgery, Tohoku University Graduate School of Medicine, 1-1 Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Matsuo', 'Affiliation': 'Division of Cardiovascular Surgery, Tohoku University Graduate School of Medicine, 1-1 Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan.'}, {'ForeName': 'Shintaro', 'Initials': 'S', 'LastName': 'Katahira', 'Affiliation': 'Division of Cardiovascular Surgery, Tohoku University Graduate School of Medicine, 1-1 Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan.'}, {'ForeName': 'Tomoyuki', 'Initials': 'T', 'LastName': 'Suzuki', 'Affiliation': 'Division of Cardiovascular Surgery, Tohoku University Graduate School of Medicine, 1-1 Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Suzuki', 'Affiliation': 'Division of Cardiovascular Surgery, Tohoku University Graduate School of Medicine, 1-1 Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Kaiho', 'Affiliation': 'Division of Epidemiology, Department of Health Informatics and Public Health, Tohoku University School of Public Health, Graduate School of Medicine, Sendai, Japan.'}, {'ForeName': 'Yumi', 'Initials': 'Y', 'LastName': 'Sugawara', 'Affiliation': 'Division of Epidemiology, Department of Health Informatics and Public Health, Tohoku University School of Public Health, Graduate School of Medicine, Sendai, Japan.'}, {'ForeName': 'Ichiro', 'Initials': 'I', 'LastName': 'Tsuji', 'Affiliation': 'Division of Epidemiology, Department of Health Informatics and Public Health, Tohoku University School of Public Health, Graduate School of Medicine, Sendai, Japan.'}, {'ForeName': 'Yoshikatsu', 'Initials': 'Y', 'LastName': 'Saiki', 'Affiliation': 'Division of Cardiovascular Surgery, Tohoku University Graduate School of Medicine, 1-1 Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan. yoshisaiki@med.tohoku.ac.jp.'}]",General thoracic and cardiovascular surgery,['10.1007/s11748-020-01364-9']
75,32379217,"A multicenter, randomized study to select the minimum effective dose of estetrol (E4) in postmenopausal women (E4Relief): part 1. Vasomotor symptoms and overall safety.","OBJECTIVE


The aim of this study was to select the minimum effective dose of estetrol (E4) for the treatment of vasomotor symptoms in postmenopausal women.
METHODS


This was a multicenter, randomized, double-blind, placebo-controlled study. Postmenopausal women (n = 257, of whom 32 were hysterectomized) aged 40 to 65 years, with ≥7 moderate to severe hot flushes (HFs) per day, or 50 or more moderate to severe HFs weekly, received 2.5, 5, 10, or 15 mg E4, or placebo once-daily for a period of 12 weeks. Efficacy was assessed by recording the frequency and severity of HFs. Overall safety was assessed by recording adverse events, measuring endometrial thickness, and monitoring bleeding patterns. Treatment groups were compared using analysis of covariance.
RESULTS


The frequency of moderate to severe HFs decreased with all E4 doses. The difference in the percentage change of weekly HF frequency was significant for 15 mg E4 versus placebo at both W4 (-66% vs -49%, P = 0.032) and W12 (-82% vs -65%, P = 0.022). The decrease in severity of HFs was significantly more pronounced for 15 mg E4 than for placebo at both W4 (-0.59 vs -0.33, P = 0.049) and W12 (-1.04 vs -0.66, P = 0.049); the other doses failed to achieve statistical significance. In nonhysterectomized women, endometrial thickness increased during treatment and normalized following progestin treatment at study completion. No endometrial hyperplasia was observed.
CONCLUSIONS


Estetrol 15 mg is considered to be the minimum effective daily oral dose for treatment of vasomotor symptoms. Its current seemingly favorable safety profile is further to be confirmed in phase 3 clinical development. : Video Summary:http://links.lww.com/MENO/A591.",2020,The decrease in severity of HFs was significantly more pronounced for 15 mg E4 than for placebo at both W4 (-0.59 vs -0.33,"['postmenopausal women', 'Postmenopausal women (n\u200a=\u200a257, of whom 32 were hysterectomized) aged 40 to 65 years, with ≥7 moderate to severe hot flushes (HFs) per day, or 50 or more moderate to severe HFs weekly, received 2.5, 5, 10, or 15\u200amg E4, or', 'postmenopausal women (E4Relief']","['placebo', ' Video Summary:http://links.lww.com/MENO/A591', 'estetrol (E4']","['severity of HFs', 'Vasomotor symptoms and overall safety', 'frequency and severity of HFs', 'adverse events, measuring endometrial thickness, and monitoring bleeding patterns', 'endometrial thickness', 'endometrial hyperplasia', 'percentage change of weekly HF frequency', 'Overall safety', 'Efficacy', 'frequency of moderate to severe HFs']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0600142', 'cui_str': 'Menopausal flushing'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C3844011', 'cui_str': '2.5'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0014899', 'cui_str': '15 alpha-Hydroxyestriol'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600142', 'cui_str': 'Menopausal flushing'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0014173', 'cui_str': 'Endometrial hyperplasia'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]",,0.222659,The decrease in severity of HFs was significantly more pronounced for 15 mg E4 than for placebo at both W4 (-0.59 vs -0.33,"[{'ForeName': 'Ulysse', 'Initials': 'U', 'LastName': 'Gaspard', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Liège, Liège, Belgium.'}, {'ForeName': 'Mélanie', 'Initials': 'M', 'LastName': 'Taziaux', 'Affiliation': 'Mithra Pharmaceuticals, Liège, Belgium.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Mawet', 'Affiliation': 'Mithra Pharmaceuticals, Liège, Belgium.'}, {'ForeName': 'Maud', 'Initials': 'M', 'LastName': 'Jost', 'Affiliation': 'Mithra Pharmaceuticals, Liège, Belgium.'}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Gordenne', 'Affiliation': 'Mithra Pharmaceuticals, Liège, Belgium.'}, {'ForeName': 'Herjan J T', 'Initials': 'HJT', 'LastName': 'Coelingh Bennink', 'Affiliation': 'Pantarhei Bioscience, Zeist, The Netherlands.'}, {'ForeName': 'Rogerio A', 'Initials': 'RA', 'LastName': 'Lobo', 'Affiliation': 'Columbia University Medical Center, New York, NY.'}, {'ForeName': 'Wulf H', 'Initials': 'WH', 'LastName': 'Utian', 'Affiliation': 'Case Western Reserve University School of Medicine, Cleveland, OH.'}, {'ForeName': 'Jean-Michel', 'Initials': 'JM', 'LastName': 'Foidart', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Liège, Liège, Belgium.'}]","Menopause (New York, N.Y.)",['10.1097/GME.0000000000001561']
76,31834064,An International Exploration of the Effect of Media Portrayals of Postconcussion Management on Concussion Identification in the General Public.,"BACKGROUND


Concussion portrayal in media broadcasts of sporting events may contribute to lack of public understanding regarding concussion.
METHODS


In total, 828 participants from Australia, New Zealand, and the United Kingdom completed a questionnaire assessing concussion knowledge. Participants were randomly assigned to either receive sports return-to-play (RTP) guideline information (RTP group) or not (no-RTP group). Participants viewed 12 short clips from televised rugby games and indicated whether they believed the player in each clip had sustained a concussion. Participants were then informed whether the player was removed, returned, or stayed in the game and again asked whether they thought a concussion had occurred.
RESULTS


Probability of reporting a likely concussion over all videos was 65.6%. When told a player's possible concussion was managed by removal from the game, participants were more likely to change their response from ""no"" (no concussion) to ""yes"" (concussion) than from ""yes"" to ""no."" When told the player stayed or returned to the game, participants were more likely to change their response from ""yes"" (concussion) to ""no"" (no concussion) than from ""no"" to ""yes."" There was no significant main effect for RTP guideline manipulation or interaction effect with RTP information.
CONCLUSION


Additional player's injury management information influenced participants' judgments of concussion occurrence. Results show that information provided via sports media broadcasts influenced viewers' perceptions of concussion and appropriate concussion management.",2020,Results show that information provided via sports media broadcasts influenced viewers' perceptions of concussion and appropriate concussion management.,"['828 participants from Australia, New Zealand, and the United Kingdom completed a questionnaire assessing concussion knowledge']","['Media Portrayals of Postconcussion Management', 'sports return-to-play (RTP) guideline information (RTP group) or not (no-RTP group']",[],"[{'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0006107', 'cui_str': 'Concussion injury of brain'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]","[{'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C4042817', 'cui_str': 'Return to Play'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]",[],828.0,0.0514657,Results show that information provided via sports media broadcasts influenced viewers' perceptions of concussion and appropriate concussion management.,"[{'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Ku', 'Affiliation': ""University of Canterbury, Christchurch, New Zealand (Ms Ku and Drs McKinlay, Grace, and McLellan); Melbourne School of Psychological Sciences, The University of Melbourne, Parkville, Victoria, Australia (Dr McKinlay); and School of Nursing and Midwifery, Queen's University, Belfast, Northern Ireland (Drs McKinlay and Linden).""}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'McKinlay', 'Affiliation': ''}, {'ForeName': 'Randolph C', 'Initials': 'RC', 'LastName': 'Grace', 'Affiliation': ''}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Linden', 'Affiliation': ''}, {'ForeName': 'Tracey', 'Initials': 'T', 'LastName': 'McLellan', 'Affiliation': ''}]",The Journal of head trauma rehabilitation,['10.1097/HTR.0000000000000547']
77,32380972,"SAFE: an eHealth intervention for women experiencing intimate partner violence - study protocol for a randomized controlled trial, process evaluation and open feasibility study.","BACKGROUND


Intimate partner violence (IPV) affects almost one in three women worldwide. However, disclosing violence or seeking help is difficult for affected women. eHealth may represent an effective alternative to the standard support offers, which often require face-to-face interaction, because of easy accessibility and possibility of anonymous usage. In the Netherlands we are developing SAFE, an eHealth intervention for female victims of IPV, which will be evaluated in a randomized controlled trial and a process evaluation, followed by an open feasibility study to assess real-world user data.
METHODS/DESIGN


The randomized controlled trial is a two-arm parallel design comparing an intervention arm and a control group. The groups both have access to eHealth but differ in the offer of interactive features compared to static information. Both groups complete questionnaires at three or four time points (baseline, three months, six months, 12 months) with self-efficacy at 6 months as the primary outcome, measured with the General Self-Efficacy (GSE) scale. The process evaluation consists of quantitative data (from the website and from web evaluation questionnaires) and qualitative data (from interviews) on how the website was used and the users' experiences.
DISCUSSION


eHealth has the potential to reach a large number of women who experience IPV. The internet-based design can lower access barriers and encourage help-seeking behavior ultimately reducing the lag time between subjective awareness and protective action.
TRIAL REGISTRATION


Trial registered on 15 August 2017 at the Netherlands Trial Register NL7108 (NTR7313).",2020,"The internet-based design can lower access barriers and encourage help-seeking behavior ultimately reducing the lag time between subjective awareness and protective action.
","['women experiencing intimate partner violence', 'Trial registered on 15 August 2017 at the Netherlands Trial Register NL7108 (NTR7313']","['eHealth intervention', 'SAFE']",['General Self-Efficacy (GSE) scale'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}]","[{'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.109392,"The internet-based design can lower access barriers and encourage help-seeking behavior ultimately reducing the lag time between subjective awareness and protective action.
","[{'ForeName': 'N E', 'Initials': 'NE', 'LastName': 'van Gelder', 'Affiliation': 'Department of Gender in Primary and Transmural Care, Radboud University Medical Center, Postbus 9101, 6500 HB Nijmegen; Geert Grooteplein 21 - route 117, 6525 EZ, Nijmegen, the Netherlands. nicole.vangelder@radboudumc.nl.'}, {'ForeName': 'K A W L', 'Initials': 'KAWL', 'LastName': 'van Rosmalen-Nooijens', 'Affiliation': 'Department of Gender in Primary and Transmural Care, Radboud University Medical Center, Postbus 9101, 6500 HB Nijmegen; Geert Grooteplein 21 - route 117, 6525 EZ, Nijmegen, the Netherlands.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'A Ligthart', 'Affiliation': 'Department of Gender in Primary and Transmural Care, Radboud University Medical Center, Postbus 9101, 6500 HB Nijmegen; Geert Grooteplein 21 - route 117, 6525 EZ, Nijmegen, the Netherlands.'}, {'ForeName': 'J B', 'Initials': 'JB', 'LastName': 'Prins', 'Affiliation': 'Department of Gender in Primary and Transmural Care, Radboud University Medical Center, Postbus 9101, 6500 HB Nijmegen; Geert Grooteplein 21 - route 117, 6525 EZ, Nijmegen, the Netherlands.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Oertelt-Prigione', 'Affiliation': 'Department of Gender in Primary and Transmural Care, Radboud University Medical Center, Postbus 9101, 6500 HB Nijmegen; Geert Grooteplein 21 - route 117, 6525 EZ, Nijmegen, the Netherlands.'}, {'ForeName': 'A L M', 'Initials': 'ALM', 'LastName': 'Lagro-Janssen', 'Affiliation': 'Department of Gender in Primary and Transmural Care, Radboud University Medical Center, Postbus 9101, 6500 HB Nijmegen; Geert Grooteplein 21 - route 117, 6525 EZ, Nijmegen, the Netherlands.'}]",BMC public health,['10.1186/s12889-020-08743-0']
78,32381188,Active SB-P Versus Conventional Approach to the Protection of High-Risk Side Branches: The CIT-RESOLVE Trial.,"OBJECTIVES


The aim of this study was to determine whether an active side branch protection (SB-P) strategy is superior to the conventional strategy in reducing side branch (SB) occlusion in high-risk bifurcation treatment.
BACKGROUND


Accurate prediction of SB occlusion after main vessel stenting followed by the use of specific strategies to prevent occlusion would be beneficial during bifurcation intervention.
METHODS


Eligible patients who had a bifurcation lesions with high risk for occlusion as determined using the validated V-RESOLVE (Visual Estimation for Risk Prediction of Side Branch Occlusion in Coronary Bifurcation Intervention) score were randomized to an active SB-P strategy group (elective 2-stent strategy for large SBs and jailed balloon technique for small SBs) or a conventional strategy group (provisional stenting for large SBs and jailed wire technique for small SBs) in a 1:1 ratio stratified by SB vessel size. The primary endpoint of SB occlusion was defined as an angiography core laboratory-assessed decrease in TIMI (Thrombolysis In Myocardial Infarction) flow grade or absence of flow in the SB immediately after full apposition of the main vessel stent to the vessel wall.
RESULTS


A total of 335 subjects at 16 sites were randomized to the SB-P group (n = 168) and conventional group (n = 167). Patients in the SB-P versus conventional strategy group had a significantly lower rate of SB occlusion (7.7% [13 of 168] vs. 18.0% [30 of 167]; risk difference: -9.1%; 95% confidence interval: -13.1% to -1.8%; p = 0.006), driven mainly by the difference in the small SB subgroup (jailed balloon technique vs. jailed wire technique: 8.1% vs. 18.5%; p = 0.01).
CONCLUSIONS


An active SB-P strategy is superior to a conventional strategy in reducing SB occlusion when treating high-risk bifurcation lesions. (Conventional Versus Intentional Strategy in Patients With High Risk Prediction of Side Branch Occlusion in Coronary Bifurcation Intervention [CIT-RESOLVE]; NCT02644434).",2020,An active SB-P strategy is superior to a conventional strategy in reducing SB occlusion when treating high-risk bifurcation lesions.,"['High-Risk\xa0Side Branches', 'A total of 335 subjects at 16 sites', 'Eligible patients who had a bifurcation lesions with high risk for occlusion as determined using the validated V-RESOLVE (Visual Estimation for Risk Prediction of Side Branch Occlusion in Coronary Bifurcation Intervention) score']","['active SB-P strategy group (elective 2-stent strategy for large SBs and jailed balloon technique for small SBs) or a conventional strategy group (provisional stenting for large SBs and jailed wire technique for small SBs', 'Active SB-P Versus Conventional Approach', 'active side branch protection (SB-P) strategy', 'Coronary Bifurcation Intervention', 'Side']","['SB occlusion', 'side branch (SB) occlusion', 'angiography core laboratory-assessed decrease in TIMI (Thrombolysis In Myocardial Infarction) flow grade or absence of flow', 'rate of SB occlusion']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0205384', 'cui_str': 'Branching'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4709307', 'cui_str': '335'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184906', 'cui_str': 'Bifurcation'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C3714811', 'cui_str': 'Resolved'}, {'cui': 'C0444684', 'cui_str': 'Visual estimation'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205384', 'cui_str': 'Branching'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0003380', 'cui_str': 'Antimony'}, {'cui': 'C0033168', 'cui_str': 'Prisons'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0005978', 'cui_str': 'Bone wire'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0184906', 'cui_str': 'Bifurcation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205384', 'cui_str': 'Branching'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0332197', 'cui_str': 'Absent'}]",335.0,0.181165,An active SB-P strategy is superior to a conventional strategy in reducing SB occlusion when treating high-risk bifurcation lesions.,"[{'ForeName': 'Kefei', 'Initials': 'K', 'LastName': 'Dou', 'Affiliation': 'State Key Laboratory of Cardiovascular Disease, Beijing, China; Department of Cardiology, Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China; National Clinical Research Center for Cardiovascular Diseases, Beijing, China. Electronic address: drdoukefei@126.com.'}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'State Key Laboratory of Cardiovascular Disease, Beijing, China; Department of Cardiology, Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China; National Clinical Research Center for Cardiovascular Diseases, Beijing, China.'}, {'ForeName': 'Hongwei', 'Initials': 'H', 'LastName': 'Pan', 'Affiliation': ""Department of Cardiology, Hunan Provincial People's Hospital, the First Affiliated Hospital of Hunan Normal University, Changsha, China.""}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Guo', 'Affiliation': ""Department of Cardiology, the First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Lang', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, the First Affiliated Hospital of Guangxi Medical University, Nanning, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, the First Affiliated Hospital of Harbin Medical University, Harbin, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology, Shanghai East Hospital, Tongji University, Shanghai, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': 'Department of Cardiology, the Second Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Zhujun', 'Initials': 'Z', 'LastName': 'Shen', 'Affiliation': 'Department of Cardiology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology, Guangdong General Hospital, Guangzhou, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ""Departments of Cardiology, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Han', 'Affiliation': ""Department of Cardiology, the Third Medical Center of the Chinese People's Liberation Army General Hospital, Beijing, China.""}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Medical Research and Biometrics Center, National Center for Cardiovascular Diseases, Beijing, China.'}, {'ForeName': 'Yanyan', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Medical Research and Biometrics Center, National Center for Cardiovascular Diseases, Beijing, China.'}, {'ForeName': 'Yuejin', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'State Key Laboratory of Cardiovascular Disease, Beijing, China; Department of Cardiology, Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China; National Clinical Research Center for Cardiovascular Diseases, Beijing, China.'}, {'ForeName': 'Shaoliang', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Lihua', 'Initials': 'L', 'LastName': 'Xie', 'Affiliation': 'Catheterization Laboratories, Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Changdong', 'Initials': 'C', 'LastName': 'Guan', 'Affiliation': 'Catheterization Laboratories, Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Ajay J', 'Initials': 'AJ', 'LastName': 'Kirtane', 'Affiliation': 'Center for Interventional Vascular Therapy, Columbia University Medical Center/NewYork-Presbyterian Hospital, and the Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': 'National Clinical Research Center for Cardiovascular Diseases, Beijing, China; Catheterization Laboratories, Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. Electronic address: bxu@citmd.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2020.01.233']
79,32386939,Effect of Protective Cover on the Quality of Life of Patients With Tracheostomy-A Quasi-Experimental Study.,"PURPOSE


Patients with tracheostomy experience problems such as the inability to speak, swallowing disorders, and impairment of body image. These problems adversely affect patients' quality of life (QoL). This study aimed to investigate the effect of discharge training and the use of a protective cover on the QoL of patients with tracheostomy and the problems experienced after discharge.
DESIGN


A quasi-experimental study.
METHODS


All patients (n = 24) were followed for 3 months after the preoperative period. Patients in the control group (CG) received routine care after surgery, whereas patients in the intervention group (IG) received routine care, discharge training, and a protective stoma cover.
FINDINGS


The 90th postdischarge day QoL scores between the CG and IG were statistically significant. Respiratory problems were the most common postdischarge problems in both groups. Patients in the CG significantly experienced more problems than those in the IG during the postdischarge period.
CONCLUSIONS


This study provides that patients can benefit from discharge training and protective cover and that health care professionals become aware of the cover for future use.",2020,"Patients in the CG significantly experienced more problems than those in the IG during the postdischarge period.
","['patients with tracheostomy and the problems experienced after discharge', 'Patients With Tracheostomy-A Quasi-Experimental Study', 'Patients with tracheostomy experience problems']","['discharge training', 'routine care, discharge training, and a protective stoma cover', 'Protective Cover']","['90th postdischarge day QoL scores', ""patients' quality of life (QoL"", 'Quality of Life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040590', 'cui_str': 'Tracheostomy'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C2985410', 'cui_str': 'Controlled Clinical Trials, Non-Randomized'}]","[{'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C1955856', 'cui_str': 'Stoma site'}, {'cui': 'C0439844', 'cui_str': 'Covered'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",24.0,0.0315949,"Patients in the CG significantly experienced more problems than those in the IG during the postdischarge period.
","[{'ForeName': 'Çiğdem Canbolat', 'Initials': 'ÇC', 'LastName': 'Seyman', 'Affiliation': 'Faculty of Nursing, Department of Surgical Nursing, Hacettepe University, Ankara, Turkey. Electronic address: cigdem_canbolat@hotmail.com.'}, {'ForeName': 'Sevilay Şenol', 'Initials': 'SŞ', 'LastName': 'Çelik', 'Affiliation': 'Faculty of Nursing, Koç University, İstanbul, Turkey.'}]",Journal of perianesthesia nursing : official journal of the American Society of PeriAnesthesia Nurses,['10.1016/j.jopan.2020.01.013']
80,32386940,Effects of Relaxation Techniques on Acute Postlaminectomy Pain: A Three-Arm Randomized Controlled Clinical Trial.,"PURPOSE


This study compared the effects of Benson relaxation with progressive muscle relaxation on pain severity after laminectomy.
DESIGN


Three-arm randomized, nonblinded, and parallel group trial.
METHODS


The study was conducted with 93 patients who underwent lumbar laminectomy. Patients were randomly assigned to three groups of Benson relaxation + routine care (n = 31), progressive muscle relaxation + routine care (n = 31), and routine care (n = 31). The two relaxation methods were performed at 2 (time 1), 12 (time 2), and 24 (time 3) hours after patients' regaining full consciousness in postoperative wards. Pain severity was assessed using the visual analog scale once before laminectomy, before and also 20 minutes after each relaxation session. In the control group, pain severity was measured at the same times as in the two relaxation groups.
FINDINGS


Both Benson relaxation and progressive muscle relaxation resulted in a significant reduction in pain severity in comparison with the control group at all three measurement times (except at time 1 in the progressive muscle relaxation group). However, no significant differences were found between Benson relaxation and progressive muscle relaxation in any of the three times.
CONCLUSIONS


The results suggest that both Benson and progressive muscle relaxation techniques can decrease acute postlaminectomy pain in the immediate postoperative period in adult patients.",2020,"FINDINGS


Both Benson relaxation and progressive muscle relaxation resulted in a significant reduction in pain severity in comparison with the control group at all three measurement times (except at time 1 in the progressive muscle relaxation group).","['adult patients', '93 patients who underwent lumbar laminectomy', 'Acute Postlaminectomy Pain']","['Relaxation Techniques', 'Benson relaxation with progressive muscle relaxation', 'Benson relaxation\xa0+\xa0routine care (n\xa0= 31), progressive muscle relaxation\xa0+\xa0routine care (n\xa0= 31), and routine care']","['acute postlaminectomy pain', 'Benson relaxation and progressive muscle relaxation', 'Pain severity', 'pain severity']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1112614', 'cui_str': 'Lumbar laminectomy'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0035029', 'cui_str': 'Relaxation technique'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0454043', 'cui_str': 'Jacobson technique'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0454043', 'cui_str': 'Jacobson technique'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",93.0,0.0186028,"FINDINGS


Both Benson relaxation and progressive muscle relaxation resulted in a significant reduction in pain severity in comparison with the control group at all three measurement times (except at time 1 in the progressive muscle relaxation group).","[{'ForeName': 'Seyed Amir Hosein', 'Initials': 'SAH', 'LastName': 'Pishgooie', 'Affiliation': 'Department of Critical Care Nursing, School of Nursing, AJA University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Fakhridokht', 'Initials': 'F', 'LastName': 'Akbari', 'Affiliation': 'Department of Nursing, Behbahan Faculty of Medical Sciences, Behbahan, Iran.'}, {'ForeName': 'Sahar', 'Initials': 'S', 'LastName': 'Keyvanloo Shahrestanaki', 'Affiliation': 'Student Research Committee, Iran University of Medical Sciences, Tehran, Iran; Nursing Care Research Center (NCRC), School of Nursing and Midwifery, Iran University of Medical Science, Tehran, Iran.'}, {'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Rezaei', 'Affiliation': 'Student Research Committee, Iran University of Medical Sciences, Tehran, Iran; Nursing Care Research Center (NCRC), School of Nursing and Midwifery, Iran University of Medical Science, Tehran, Iran.'}, {'ForeName': 'Morteza', 'Initials': 'M', 'LastName': 'Nasiri', 'Affiliation': 'Student Research Committee, Shiraz University of Medical Sciences, Shiraz, Iran; Department of Operating Room Nursing, School of Nursing and Midwifery, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Momen', 'Affiliation': 'Department of Critical Care Nursing, School of Nursing, AJA University of Medical Sciences, Tehran, Iran. Electronic address: Rezamomen88@yahoo.com.'}]",Journal of perianesthesia nursing : official journal of the American Society of PeriAnesthesia Nurses,['10.1016/j.jopan.2020.02.004']
81,32388622,"The effect of oxytocin, gender, and ovarian hormones on stress reactivity in individuals with cocaine use disorder.","RATIONALE


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


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


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


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


Oxytocin may have differential effects in men and women with CUD. Women may be at greater risk for relapse in response to social stressors, but ovarian hormones may attenuate this effect.",2020,There was a main effect of gender on subjective stress response; women reported greater stress following the stressor compared to men (p = 0.016).,"['individuals with cocaine use disorder', 'Men and women with CUD differ in reactivity to social stressors', 'One hundred twelve adults with CUD', 'individuals with CUD', 'men and women with CUD', 'gender (female (F) vs. male (M']","['oxytocin', 'oxytocin (oxytocin (OXY) vs. placebo (PBO', 'Oxytocin', '40 IU intranasal oxytocin (n\u2009=\u200956) or matching placebo']","['subjective stress response', 'blunted cortisol response', 'craving or stress', 'neuroendocrine response', 'craving response', 'neuroendocrine (cortisol) and subjective (craving, stress) response']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0031962', 'cui_str': 'Piperonyl Butoxide'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C1997138', 'cui_str': 'Blunted'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0027912', 'cui_str': 'Neuroendocrine System'}]",112.0,0.0816261,There was a main effect of gender on subjective stress response; women reported greater stress following the stressor compared to men (p = 0.016).,"[{'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Sherman', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, 125 Doughty Street, Suite 190, Charleston, SC, 29425, USA. shermanb@musc.edu.'}, {'ForeName': 'Nathaniel L', 'Initials': 'NL', 'LastName': 'Baker', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Kathleen T', 'Initials': 'KT', 'LastName': 'Brady', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, 125 Doughty Street, Suite 190, Charleston, SC, 29425, USA.'}, {'ForeName': 'Jane E', 'Initials': 'JE', 'LastName': 'Joseph', 'Affiliation': 'Department of Neuroscience, Medical University of South Carolina, Charleston, USA.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Nunn', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, 125 Doughty Street, Suite 190, Charleston, SC, 29425, USA.'}, {'ForeName': 'Aimee', 'Initials': 'A', 'LastName': 'McRae-Clark', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, 125 Doughty Street, Suite 190, Charleston, SC, 29425, USA.'}]",Psychopharmacology,['10.1007/s00213-020-05516-w']
82,32327729,Deepening responses associated with improved progression-free survival with ixazomib versus placebo as posttransplant maintenance in multiple myeloma.,"In the TOURMALINE-MM3 study, post-autologous stem cell transplantation maintenance therapy with the oral proteasome inhibitor ixazomib versus placebo significantly improved progression-free survival (PFS), with a favorable safety profile. With ixazomib versus placebo maintenance, deepening responses occurred in 139/302 (46%) versus 60/187 (32%) patients with very good partial response or partial response (VGPR/PR) at study entry (relative risk 1.41, P = 0.004), and median time to best confirmed deepened response was 19.9 versus 30.8 months (24-month rate: 54.2 versus 41.4%; hazard ratio (HR): 1.384; P = 0.0342). Median PFS in patients with VGPR/PR at study entry was 26.2 versus 18.5 months (HR: 0.636, P < 0.001) with ixazomib versus placebo; in a pooled analysis across arms, in patients with versus without deepening responses, the median PFS was not reached versus 15.9 months (HR: 0.245, P < 0.001). In patients with deepening responses, 24-month PFS rate was 77.4 versus 68.3% with ixazomib versus placebo (HR: 0.831; P = 0.466); in patients without deepening responses, median PFS was 17.9 versus 14.1 months (HR: 0.741; P = 0.028). These analyses demonstrate the significantly higher rate of deepening responses with ixazomib versus placebo maintenance and the association between deepening response and prolonged PFS.",2020,"In patients with deepening responses, 24-month PFS rate was 77.4 versus 68.3% with ixazomib versus placebo (HR: 0.831; P = 0.466); in patients without deepening responses, median PFS was 17.9 versus 14.1 months (HR: 0.741; P = 0.028).",[],"['placebo', 'ixazomib versus placebo', 'ixazomib']","['partial response or partial response (VGPR/PR', 'progression-free survival (PFS', '24-month PFS rate', 'median PFS', 'Median PFS', 'progression-free survival']",[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3273711', 'cui_str': 'ixazomib'}]","[{'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C3641222', 'cui_str': 'Very good'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",,0.0931225,"In patients with deepening responses, 24-month PFS rate was 77.4 versus 68.3% with ixazomib versus placebo (HR: 0.831; P = 0.466); in patients without deepening responses, median PFS was 17.9 versus 14.1 months (HR: 0.741; P = 0.028).","[{'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Goldschmidt', 'Affiliation': 'Internal Medicine V and National Center for Tumor Diseases (NCT), University Clinic Heidelberg, Heidelberg, Germany. Hartmut.Goldschmidt@med.uni-heidelberg.de.'}, {'ForeName': 'Meletios A', 'Initials': 'MA', 'LastName': 'Dimopoulos', 'Affiliation': 'Hematology & Medical Oncology, Department of Clinical Therapeutics, National and Kapodistrian University of Athens, School of Medicine, Athens, Greece.'}, {'ForeName': 'S Vincent', 'Initials': 'SV', 'LastName': 'Rajkumar', 'Affiliation': 'Division of Hematology, Department of Internal Medicine, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Katja C', 'Initials': 'KC', 'LastName': 'Weisel', 'Affiliation': 'Department of Oncology, Hematology and Bone Marrow Transplantation with Section of Pneumology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Moreau', 'Affiliation': 'Department of Hematology, University Hospital Hôtel Dieu, University of Nantes, Nantes, France.'}, {'ForeName': 'Wee-Joo', 'Initials': 'WJ', 'LastName': 'Chng', 'Affiliation': 'Department of Haematology-Oncology, National University Cancer Institute, National University Health System, Singapore, Singapore.'}, {'ForeName': 'Gábor', 'Initials': 'G', 'LastName': 'Mikala', 'Affiliation': 'South Pest Central Hospital, National Institute for Hematology and Infectious Diseases, Budapest, Hungary.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Cavo', 'Affiliation': 'Seràgnoli Institute of Hematology, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Karthik', 'Initials': 'K', 'LastName': 'Ramasamy', 'Affiliation': 'Oxford University Hospitals, NHS Foundation Trust, Oxford Myeloma Centre for Translational Research, Oxford, UK.'}, {'ForeName': 'Kaveri', 'Initials': 'K', 'LastName': 'Suryanarayan', 'Affiliation': 'Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA.'}, {'ForeName': 'Zhaoyang', 'Initials': 'Z', 'LastName': 'Teng', 'Affiliation': 'Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Labotka', 'Affiliation': 'Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA.'}, {'ForeName': 'Maria Victoria', 'Initials': 'MV', 'LastName': 'Mateos', 'Affiliation': 'Hematology, Hospital Universitario de Salamanca, University Hospital of Salamanca, IBSAL, CIC, IBMCC (USAL-CSIC), Salamanca, Spain.'}]",Leukemia,['10.1038/s41375-020-0819-8']
83,32394228,"The GLP-1 receptor agonist lixisenatide reduces postprandial glucose in patients with diabetes secondary to total pancreatectomy: a randomised, placebo-controlled, double-blinded crossover trial.","AIMS/HYPOTHESIS


Treatment of diabetes secondary to total pancreatectomy remains a challenge and insulin constitutes the only glucose-lowering treatment for these patients. We hypothesised that the glucagon-like peptide 1 (GLP-1) receptor agonist lixisenatide would improve postprandial glucose tolerance in totally pancreatectomised patients.
METHODS


In a double-blinded, randomised, crossover study, 12 totally pancreatectomised individuals (age: 65.0 ± 9.5 mean±SD years; BMI: 22.9 ± 3.9 kg/m 2 ) and 12 healthy control individuals (age 66.1 ± 7.6 years; BMI: 24.0 ± 2.9 kg/m 2 ) underwent two 3 h liquid mixed-meal tests (with paracetamol for assessment of gastric emptying) after single-dose injection of 20 μg of lixisenatide or placebo. Basal insulin was given the night before each experimental day; no insulin was given during study days.
RESULTS


Compared with placebo, lixisenatide reduced postprandial plasma glucose excursions in the pancreatectomy group (baseline-subtracted AUC [bsAUC] [mean±SEM]: 548 ± 125 vs 1447 ± 95 mmol/l × min, p < 0.001) and in the control group (-126 ± 12 vs 222 ± 51 mmol/l × min, p < 0.001). In the pancreatectomy group a mean peak glucose concentration of 23.3 ± 1.0 mmol/l was reached at time point 134 ± 11 min with placebo, compared with a mean peak glucose concentration of 18 ± 1.4 mmol/l (p = 0.008) at time point 148 ± 13 min (p = 0.375) with lixisenatide. In the control group a mean peak concentration of 8.2 ± 0.4 mmol/l was reached at time point 70 ± 13 min with placebo, compared with a mean peak concentration of 5.5 ± 0.1 mmol/l (p < 0.001) at time point 8 ± 25 min (p = 0.054) with lixisenatide. Lixisenatide also reduced gastric emptying and postprandial glucagon responses in the pancreatectomy group (66 ± 84 vs 1190 ± 311 pmol/l × min, p = 0.008) and in the control group (141 ± 100 vs 190 ± 100 pmol/l × min, p = 0.034). In the pancreatectomy group, C-peptide was undetectable in plasma. In the control group, postprandial plasma C-peptide responses were reduced with lixisenatide (18 ± 17 vs 189 ± 31 nmol/l × min, p < 0.001).
CONCLUSIONS/INTERPRETATION


The GLP-1 receptor agonist lixisenatide reduces postprandial plasma glucose excursions in totally pancreatectomised patients. The mode of action seems to involve deceleration of gastric emptying and reduced postprandial responses of gut-derived glucagon.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02640118.
FUNDING


This study was funded by an unrestricted investigator-initiated study grant from Sanofi. Support was also received from from the Novo Nordisk Foundation Center for Basic Metabolic Research, the A.P. Møller Foundation for the Advancement of Medical Science and the Faculty of Health and Medical Sciences, University of Copenhagen.",2020,"Compared with placebo, lixisenatide reduced postprandial plasma glucose excursions in the pancreatectomy group (baseline-subtracted AUC [bsAUC] [mean±SEM]: 548 ± 125 vs 1447 ± 95 mmol/l × min, p < 0.001) and in the control group (-126 ± 12 vs 222 ± 51 mmol/l × min, p < 0.001).","['patients with diabetes secondary to total pancreatectomy', 'totally pancreatectomised patients', '12 totally pancreatectomised individuals (age: 65.0\u2009±\u20099.5 mean±SD years; BMI: 22.9\u2009±\u20093.9\xa0kg/m 2 ) and 12 healthy control individuals (age 66.1\u2009±\u20097.6\xa0years; BMI: 24.0\u2009±\u20092.9\xa0kg/m 2 ) underwent']","['placebo, lixisenatide', 'glucagon-like peptide 1 (GLP-1) receptor agonist lixisenatide', 'lixisenatide or placebo', 'GLP-1 receptor agonist lixisenatide', 'two 3\xa0h liquid mixed-meal tests (with paracetamol', 'placebo']","['mean peak glucose concentration', 'postprandial plasma C-peptide responses', 'postprandial glucose tolerance', 'mean peak concentration', 'gastric emptying and postprandial glucagon responses', 'postprandial plasma glucose excursions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}, {'cui': 'C0040511', 'cui_str': 'Total pancreatectomy'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517899', 'cui_str': '9.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517698', 'cui_str': '3.9'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517641', 'cui_str': '2.9'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2973895', 'cui_str': 'Lixisenatide'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C2987634', 'cui_str': 'Receptor agonist'}, {'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}, {'cui': 'C0041119', 'cui_str': 'Tritium'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0427743', 'cui_str': 'Glucose concentration, test strip measurement'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0006558', 'cui_str': 'C-peptide'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0017127', 'cui_str': 'Gastric emptying'}, {'cui': 'C0017687', 'cui_str': 'Glucagon'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}]",12.0,0.174112,"Compared with placebo, lixisenatide reduced postprandial plasma glucose excursions in the pancreatectomy group (baseline-subtracted AUC [bsAUC] [mean±SEM]: 548 ± 125 vs 1447 ± 95 mmol/l × min, p < 0.001) and in the control group (-126 ± 12 vs 222 ± 51 mmol/l × min, p < 0.001).","[{'ForeName': 'Caroline T B', 'Initials': 'CTB', 'LastName': 'Juel', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Gentofte Hospitalsvej 7, 3rd floor, DK-2900, Hellerup, Denmark.'}, {'ForeName': 'Asger', 'Initials': 'A', 'LastName': 'Lund', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Gentofte Hospitalsvej 7, 3rd floor, DK-2900, Hellerup, Denmark.'}, {'ForeName': 'Maria M', 'Initials': 'MM', 'LastName': 'Andersen', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Gentofte Hospitalsvej 7, 3rd floor, DK-2900, Hellerup, Denmark.'}, {'ForeName': 'Carsten P', 'Initials': 'CP', 'LastName': 'Hansen', 'Affiliation': 'Department of Surgery and Transplantation, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jan H', 'Initials': 'JH', 'LastName': 'Storkholm', 'Affiliation': 'Department of Surgery and Transplantation, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jens F', 'Initials': 'JF', 'LastName': 'Rehfeld', 'Affiliation': 'Department of Clinical Biochemistry, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Gerrit', 'Initials': 'G', 'LastName': 'van Hall', 'Affiliation': 'Department of Clinical Biochemistry, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Bolette', 'Initials': 'B', 'LastName': 'Hartmann', 'Affiliation': 'Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Nicolai J', 'Initials': 'NJ', 'LastName': 'Wewer Albrechtsen', 'Affiliation': 'Department of Clinical Biochemistry, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jens J', 'Initials': 'JJ', 'LastName': 'Holst', 'Affiliation': 'Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Vilsbøll', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Gentofte Hospitalsvej 7, 3rd floor, DK-2900, Hellerup, Denmark.'}, {'ForeName': 'Filip K', 'Initials': 'FK', 'LastName': 'Knop', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Gentofte Hospitalsvej 7, 3rd floor, DK-2900, Hellerup, Denmark. filip.krag.knop.01@regionh.dk.'}]",Diabetologia,['10.1007/s00125-020-05158-9']
84,32334460,Comparison of the Outcome of Low Dose and High-Dose Corticosteroid in the Treatment of Idiopathic Granulomatous Mastitis.,"BACKGROUND


Idiopathic granulomatous mastitis (IGM) is a rare chronic inflammatory breast condition with unknown etiology. Different treatments including corticosteroids have been recommended with no universal consensus. In this study we evaluated the efficacy of low dose vs. high dose prednisolone in treatment of IGM.
METHODS


In this randomized clinical trial, 30 female patients with IGM were randomly allocated to receive low dose or high dose prednisolone. First group received 5 mg daily prednisolone, while the second group received 50 mg for three days, 25 mg for the next three days and then 12.5 mg for further three days and 5 mg daily afterwards, both for two months. Patients were evaluated 2, 3, 6 and 12 months after treatment. The success and recurrence rate was compared between groups.
RESULTS


High dose group had significantly higher rate of remission compared to low dose group (93.3% vs. 53.3%, p=0.03). One patient in high dose group and 5 patients in low dose group underwent lumpectomy due to persistent symptoms. Two other patients in low dose group received high dose treatment after three months due to no change in symptoms. Among patients with remission, recurrence was also significantly lower in high dose compared to low dose prednisolone (0% vs. 37.5%, p=0.04).
CONCLUSION


High dose prednisolone has high success rate with lower recurrence in the treatment of IGM and could reduce the need for surgery. However, further studies are necessary to confirm these findings.",2020,"RESULTS


High dose group had significantly higher rate of remission compared to low dose group (93.3% vs. 53.3%, p=0.03).","['Idiopathic Granulomatous Mastitis', '30 female patients with IGM']","['Low Dose and High-Dose Corticosteroid', 'prednisolone', 'corticosteroids']","['rate of remission', 'success and recurrence rate']","[{'cui': 'C4552494', 'cui_str': 'Idiopathic granulomatous mastitis'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]",30.0,0.0888614,"RESULTS


High dose group had significantly higher rate of remission compared to low dose group (93.3% vs. 53.3%, p=0.03).","[{'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Montazer', 'Affiliation': 'Department of General Surgery, Imam Reza Hospital, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Dadashzadeh', 'Affiliation': 'Department of General Surgery, Imam Reza Hospital, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Seyed Ehsan', 'Initials': 'SE', 'LastName': 'Moosavi Toomatari', 'Affiliation': 'Department of General Surgery, Imam Reza Hospital, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran.'}]",Asian Pacific journal of cancer prevention : APJCP,['10.31557/APJCP.2020.21.4.993']
85,30368651,"A Qualitative Exploration of Women's Experiences with a Community Health Volunteer-Led Cervical Cancer Educational Module in Migori County, Kenya.","Detection and treatment of human papillomavirus (HPV) and cervical precancer through screening programs is an effective way to reduce cervical cancer deaths. However, high cervical cancer mortality persists in low- and middle-income countries. As screening programs become more widely available, it is essential to understand how knowledge about cervical cancer and perceived disease risk impacts screening uptake and acceptability. We evaluated women's experiences with a cervical cancer education strategy led by community health volunteers (CHVs) in Migori County, Kenya, as part of a cluster randomized controlled trial of cervical cancer screening implementation strategies. The educational modules employed simple language and images and sought to increase understanding of the relationship between HPV and cervical cancer, the mechanisms of self-collected HPV testing, and the importance of cervical cancer screening. Modules took place in three different contexts throughout the study: (1) during community mobilization; (2) prior to screening in either community health campaigns or health facilities; and (3) prior to treatment. Between January and September 2016, we conducted in-depth interviews with 525 participants to assess their experience with various aspects of the screening program. After the context-specific educational modules, women reported increased awareness of cervical cancer screening and willingness to screen, described HPV- and cervical cancer-related stigma and emphasized the use of educational modules to reduce stigma. Some misconceptions about cervical cancer were evident. With effective and context-specific training, lay health workers, such as CHVs, can help bridge the gap between cervical cancer screening uptake and acceptability.",2020,"After the context-specific educational modules, women reported increased awareness of cervical cancer screening and willingness to screen, described HPV- and cervical cancer-related stigma and emphasized the use of educational modules to reduce stigma.","[""women's experiences with a cervical cancer education strategy led by community health volunteers (CHVs) in Migori County, Kenya"", ""Women's Experiences with a Community Health Volunteer-Led Cervical Cancer Educational Module in Migori County, Kenya"", '525 participants to assess their experience with various aspects of the screening program']",[],"['awareness of cervical cancer screening and willingness to screen, described HPV- and cervical cancer-related stigma', 'cervical cancer mortality']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix (disorder)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0022558', 'cui_str': 'Republic of Kenya'}, {'cui': 'C3542953', 'cui_str': 'Module (core metadata concept)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]",[],"[{'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix (disorder)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0277787', 'cui_str': 'Stigma (finding)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",,0.0196419,"After the context-specific educational modules, women reported increased awareness of cervical cancer screening and willingness to screen, described HPV- and cervical cancer-related stigma and emphasized the use of educational modules to reduce stigma.","[{'ForeName': 'Yujung', 'Initials': 'Y', 'LastName': 'Choi', 'Affiliation': 'Duke Global Health Institute, Box 90519, 310 Trent Drive, Durham, NC, 27708, USA. yujung.choi@duke.edu.'}, {'ForeName': 'Sandra Y', 'Initials': 'SY', 'LastName': 'Oketch', 'Affiliation': 'Center for Microbiology Research, Kenya Medical Research Institute, P.O. Box 54840 00200, Mbagathi Road, Nairobi, Kenya.'}, {'ForeName': 'Konyin', 'Initials': 'K', 'LastName': 'Adewumi', 'Affiliation': 'Duke Global Health Institute, Box 90519, 310 Trent Drive, Durham, NC, 27708, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Bukusi', 'Affiliation': 'Center for Microbiology Research, Kenya Medical Research Institute, P.O. Box 54840 00200, Mbagathi Road, Nairobi, Kenya.'}, {'ForeName': 'Megan J', 'Initials': 'MJ', 'LastName': 'Huchko', 'Affiliation': 'Duke Global Health Institute, Box 90519, 310 Trent Drive, Durham, NC, 27708, USA.'}]",Journal of cancer education : the official journal of the American Association for Cancer Education,['10.1007/s13187-018-1437-2']
86,31326523,"MIND food and speed of processing training in older adults with low education, the MINDSpeed Alzheimer's disease prevention pilot trial.","BACKGROUND


Multiple national organizations and leaders have called for increased attention to dementia prevention in those most vulnerable, for example persons with limited formal education. Prevention recommendations have included calls for multicomponent interventions that have the potential to improve both underlying neurobiological health and the ability to function despite neurobiological pathology, or what has been termed cognitive reserve.
OBJECTIVES


Test feasibility, treatment modifier, mechanism, and cognitive function effects of a multicomponent intervention consisting of foods high in polyphenols (i.e., MIND foods) to target neurobiological health, and speed of processing training to enhance cognitive reserve. We refer to this multicomponent intervention as MINDSpeed.
DESIGN


MINDSpeed is being evaluated in a 2 × 2 randomized factorial design with 180 participants residing independently in a large Midwestern city. Qualifying participants are 60 years of age or older with no evidence of dementia, and who have completed 12 years or less of education. All participants receive a study-issued iPad to access the custom study application that enables participants, depending on randomization, to select either control or MIND food, and to play online cognitive games, either speed of processing or control games.
METHODS


All participants complete informed consent and baseline assessment, including urine and blood samples. Additionally, up to 90 participants will complete neuroimaging. Assessments are repeated immediately following 12 weeks of active intervention, and at 24 weeks post-randomization. The primary outcome is an executive cognitive composite score. Secondary outcomes include oxidative stress, pro-inflammatory cytokines, and neuroimaging-captured structural and functional metrics of the hippocampus and cortical brain regions.
SUMMARY


MINDSpeed is the first study to evaluate the multicomponent intervention of high polyphenol intake and speed of processing training. It is also one of the first dementia prevention trials to target older adults with low education. The results of the study will guide future dementia prevention efforts and trials in high risk populations.",2019,"Prevention recommendations have included calls for multicomponent interventions that have the potential to improve both underlying neurobiological health and the ability to function despite neurobiological pathology, or what has been termed cognitive reserve.
","['older adults with low education', '180 participants residing independently in a large Midwestern city', 'Qualifying participants are 60\u202fyears of age or older with no evidence of dementia, and who have completed 12\u202fyears or less of education']","['multicomponent intervention consisting of foods high in polyphenols (i.e., MIND foods', 'MIND food and speed of processing training', 'control or MIND food, and to play online cognitive games, either speed of processing or control games']","['oxidative stress, pro-inflammatory cytokines, and neuroimaging-captured structural and functional metrics of the hippocampus and cortical brain regions', 'executive cognitive composite score']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332125', 'cui_str': 'No evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol (substance)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0032214', 'cui_str': 'Play'}]","[{'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0679575', 'cui_str': 'Neuroimaging'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0949582', 'cui_str': 'Seahorses'}, {'cui': 'C1273723', 'cui_str': 'Brain region'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",180.0,0.0716363,"Prevention recommendations have included calls for multicomponent interventions that have the potential to improve both underlying neurobiological health and the ability to function despite neurobiological pathology, or what has been termed cognitive reserve.
","[{'ForeName': 'Daniel O', 'Initials': 'DO', 'LastName': 'Clark', 'Affiliation': 'Indiana University Center for Aging Research, Indianapolis, IN, United States of America; Regenstrief Institute, Inc., Indianapolis, IN, United States of America; Department of Medicine, Division of General Internal Medicine and Geriatrics, Indiana University School of Medicine, Indianapolis, IN, United States of America. Electronic address: daniclar@iu.edu.'}, {'ForeName': 'Huiping', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Indiana University Center for Aging Research, Indianapolis, IN, United States of America; Regenstrief Institute, Inc., Indianapolis, IN, United States of America; Indiana University Richard M. Fairbanks School of Public Health, Indianapolis, IN, United States of America.'}, {'ForeName': 'Lyndsi', 'Initials': 'L', 'LastName': 'Moser', 'Affiliation': 'Department of Psychiatry, Indiana University School of Medicine, Indianapolis, IN, United States of America.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Adeoye', 'Affiliation': 'Indiana University Center for Aging Research, Indianapolis, IN, United States of America; Regenstrief Institute, Inc., Indianapolis, IN, United States of America.'}, {'ForeName': 'Annie W', 'Initials': 'AW', 'LastName': 'Lin', 'Affiliation': 'Department of Preventive Medicine, Northwestern University, Chicago, IL, United States of America.'}, {'ForeName': 'Christy C', 'Initials': 'CC', 'LastName': 'Tangney', 'Affiliation': 'Department of Clinical Nutrition, Rush University Medical Center, Chicago, IL, United States of America.'}, {'ForeName': 'Shannon L', 'Initials': 'SL', 'LastName': 'Risacher', 'Affiliation': 'Center for Neuroimaging, Department of Radiology and Imaging Sciences, Indiana University School of Medicine, Indianapolis, IN, United States of America.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Saykin', 'Affiliation': 'Center for Neuroimaging, Department of Radiology and Imaging Sciences, Indiana University School of Medicine, Indianapolis, IN, United States of America.'}, {'ForeName': 'Robert V', 'Initials': 'RV', 'LastName': 'Considine', 'Affiliation': 'Department of Medicine, Division of Endocrinology, Indiana University School of Medicine, Indianapolis, IN, United States of America.'}, {'ForeName': 'Frederick W', 'Initials': 'FW', 'LastName': 'Unverzagt', 'Affiliation': 'Indiana University Center for Aging Research, Indianapolis, IN, United States of America; Regenstrief Institute, Inc., Indianapolis, IN, United States of America; Department of Psychiatry, Indiana University School of Medicine, Indianapolis, IN, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105814']
87,31343761,Prevention of Suicidal Behavior with Telemedicine in Patients with a Recent Suicide Attempt: Is a 6-month Intervention Long Enough?,"OBJECTIVE


To analyze the results of a 6-month telephone follow-up program for the prevention of suicidality in adult patients discharged from three general hospitals after a suicide attempt. Results are compared with traditional programs lasting 12 months or more.
METHODS


This is a prospective, multicenter, study with the control group. Patients in the intervention group received five protocolized telephone calls which were added to their usual treatment. Those in the control group only received usual treatment. Each patient was followed up for 12 months.
RESULTS


A total of 123 patients were included in the intervention group and 463 in the control group. 57.7% received at least three calls. Patients in the intervention group took longer to perform a reattempt (p = .05). The percentage of those who did a reattempt (p = .67) and the number of reattempts per patient (p = .66) did not differ between groups. Those in the intervention group showed higher percentages of adherence to the outpatient follow-up (p < .001).
CONCLUSION


The intervention was well accepted and showed improved percentages of adherence to outpatient follow-up; however, the results in the prevention of suicidality were worse than those obtained by programs lasting 12 months or more. It is advisable to maintain the telephone follow-up for a minimum of 12 months.",2020,"Those in the intervention group showed higher percentages of adherence to the outpatient follow-up (p < .001).
","['Patients with a Recent Suicide Attempt', 'adult patients discharged from three general hospitals after a suicide attempt', '123 patients were included in the intervention group and 463 in the control group']","['Telemedicine', 'protocolized telephone calls', 'telephone follow-up program']",['adherence'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0038663', 'cui_str': 'Suicide attempt (event)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030685', 'cui_str': 'Patient Discharge'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0178941', 'cui_str': 'Telephone follow-up'}, {'cui': 'C2728259', 'cui_str': 'Program'}]",[],123.0,0.028,"Those in the intervention group showed higher percentages of adherence to the outpatient follow-up (p < .001).
","[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Gabilondo', 'Affiliation': 'Outpatient Public Psychiatric Network of Gipuzkoa, Osakidetza, Basque Country, Spain.'}, {'ForeName': 'Edurne', 'Initials': 'E', 'LastName': 'Aristegi', 'Affiliation': 'Hospital Universitario de Araba, Osakidetza, Basque Country, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Gonzalez-Pinto', 'Affiliation': 'Hospital de Galdakao, Osakidetza, Basque Country, Spain.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Martin Zurimendi', 'Affiliation': 'Hospital Universitario de Araba, Osakidetza, Basque Country, Spain.'}, {'ForeName': 'Maider', 'Initials': 'M', 'LastName': 'Mateos Del Pino', 'Affiliation': 'Hospital de Galdakao, Osakidetza, Basque Country, Spain.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Roca', 'Affiliation': 'Consejo Sanitario, Osakidetza, Basque Country, Spain.'}, {'ForeName': 'Iñaki', 'Initials': 'I', 'LastName': 'Zorrilla', 'Affiliation': 'Hospital de Galdakao, Osakidetza, Basque Country, Spain.'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Iruin', 'Affiliation': 'Outpatient Public Psychiatric Network of Gipuzkoa, Osakidetza, Basque Country, Spain.'}]",Suicide & life-threatening behavior,['10.1111/sltb.12576']
88,31344520,A virtual learning collaborative to implement health promotion in routine mental health settings: Protocol for a cluster randomized trial.,"BACKGROUND


Despite widespread use of learning collaboratives in health care, few randomized trials have evaluated their effectiveness. The primary aim of this cluster randomized implementation trial is to evaluate the effectiveness of a virtual learning collaborative (VLC) in the implementation of a lifestyle intervention for persons with serious mental illness (SMI) in routine mental health settings, compared to standard individual technical assistance.
METHODS


Forty-eight mental health provider organizations from across the United States will be recruited to participate in the trial. The evidence-based practice to be implemented is the InSHAPE health promotion intervention for persons with SMI. Sites will be stratified by size and randomized to receive an 18-month intensive group-based VLC with monthly learning sessions or individual technical assistance with four scheduled conference calls over 18 months. Sites will be enrolled in three blocks of 16 sites each. The primary outcomes are InSHAPE program participation and fidelity, and participant weight loss; secondary outcomes are program operation, program uptake, participant health behaviors of physical activity and nutrition, organizational change, and program sustainment. Implementation outcomes are measured at 3, 6, 12, 18, and 24 months after the program start-up. Participant-level outcomes are measured at fixed intervals every 3 months after each participant enrolls in the study.
DISCUSSION


This study will determine whether VLCs are an effective implementation strategy among resource-limited providers when the new practice necessitates a shift in mission, scope of practice, type of services delivered, and new financing.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT03891368 Registered 25 March 2019, retrospectively registered. https://clinicaltrials.gov/ct2/show/NCT03891368?term=NCT03891368&rank=1.",2019,"The primary aim of this cluster randomized implementation trial is to evaluate the effectiveness of a virtual learning collaborative (VLC) in the implementation of a lifestyle intervention for persons with serious mental illness (SMI) in routine mental health settings, compared to standard individual technical assistance.
","['Forty-eight mental health provider organizations from across the United States will be recruited to participate in the trial', 'routine mental health settings', 'persons with serious mental illness (SMI) in routine mental health settings', 'persons with SMI']","['intensive group-based VLC with monthly learning sessions or individual technical assistance', 'VLCs', 'virtual learning collaborative (VLC']","['InSHAPE program participation and fidelity, and participant weight loss; secondary outcomes are program operation, program uptake, participant health behaviors of physical activity and nutrition, organizational change, and program sustainment']","[{'cui': 'C4319608', 'cui_str': 'Forty-eight'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0220885', 'cui_str': 'organization'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C0915075', 'cui_str': 'samarium diiodide'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0018687'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0086739', 'cui_str': 'Change, Organizational'}]",48.0,0.174307,"The primary aim of this cluster randomized implementation trial is to evaluate the effectiveness of a virtual learning collaborative (VLC) in the implementation of a lifestyle intervention for persons with serious mental illness (SMI) in routine mental health settings, compared to standard individual technical assistance.
","[{'ForeName': 'Kelly A', 'Initials': 'KA', 'LastName': 'Aschbrenner', 'Affiliation': 'Department of Psychiatry, Geisel School of Medicine at Dartmouth, Lebanon, NH, United States of America; The Dartmouth Institute for Health Policy and Clinical Practice, Lebanon, NH, United States of America. Electronic address: Kelly.Aschbrenner@dartmouth.edu.'}, {'ForeName': 'Sarah I', 'Initials': 'SI', 'LastName': 'Pratt', 'Affiliation': 'Department of Psychiatry, Geisel School of Medicine at Dartmouth, Lebanon, NH, United States of America; The Dartmouth Institute for Health Policy and Clinical Practice, Lebanon, NH, United States of America. Electronic address: Sarah.Pratt@dartmouth.edu.'}, {'ForeName': 'Gary R', 'Initials': 'GR', 'LastName': 'Bond', 'Affiliation': 'Westat, Lebanon, NH, United States of America. Electronic address: GaryBond@westat.com.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Zubkoff', 'Affiliation': 'Department of Psychiatry, Geisel School of Medicine at Dartmouth, Lebanon, NH, United States of America; The Dartmouth Institute for Health Policy and Clinical Practice, Lebanon, NH, United States of America; White River Junction VAMC, White River Junction, VT, United States of America. Electronic address: Lisa.Zubkoff@dartmouth.edu.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Naslund', 'Affiliation': 'Department of Global Health & Social Medicine, Harvard Medical School, Boston, MA, United States of America. Electronic address: John_Naslund@hms.harvard.edu.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Jue', 'Affiliation': 'Ken Jue Consulting, Keene, NH, United States of America. Electronic address: ken@kenjue.com.'}, {'ForeName': 'Gail', 'Initials': 'G', 'LastName': 'Williams', 'Affiliation': 'Department of Psychiatry, Geisel School of Medicine at Dartmouth, Lebanon, NH, United States of America. Electronic address: Gail.E.Williams@dartmouth.edu.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Kinney', 'Affiliation': 'Department of Psychiatry, Geisel School of Medicine at Dartmouth, Lebanon, NH, United States of America. Electronic address: Allison.R.Kinney@dartmouth.edu.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Cohen', 'Affiliation': 'MJC Health Solutions, Amherst, NH, United States of America. Electronic address: michael@mjchealthsolutions.com.'}, {'ForeName': 'Marjorie M', 'Initials': 'MM', 'LastName': 'Godfrey', 'Affiliation': 'The Dartmouth Institute for Health Policy and Clinical Practice, Lebanon, NH, United States of America. Electronic address: Marjorie.M.Godfrey@dartmouth.edu.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Bartels', 'Affiliation': 'Department of Psychiatry, Geisel School of Medicine at Dartmouth, Lebanon, NH, United States of America; The Mongan Institute, Massachusetts General Hospital, Boston, MA, United States of America. Electronic address: SJBARTELS@mgh.harvard.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105816']
89,31344519,Individual and family-based approaches to increase physical activity in adolescents with intellectual and developmental disabilities: Rationale and design for an 18 month randomized trial.,"Adolescents with intellectual and developmental disabilities (IDD) are less physically active and have lower cardiovascular fitness compared with their typically developing peers. This population faces additional barriers to participation in moderate-to-vigorous physical activity (MVPA) such as reliance on parents, lack of peer-support, and lack of inclusive physical activity opportunities. Previous interventions to increase MVPA in adolescents with IDD have met with limited success, at least in part due to requiring parents to transport their adolescent to an exercise facility. We recently developed a remote system to deliver MVPA to groups of adolescents with IDD in their homes via video conferencing on a tablet computer. This approach eliminates the need for transportation and provides social interaction and support from both a health coach and other participants. We will conduct a 18-mo. trial (6 mos. active, 6 mos. maintenance, 6 mos. no-contact follow-up) to compare changes in objectively assessed MVPA in 114 adolescents with IDD randomized to a single level intervention delivered only to the adolescent (AO) or a multi-level intervention delivered to both the adolescent and a parent (A + P). Our primary aim is to compare increases in MVPA (min/d) between the AO and A + P groups from 0 to 6 mos. Secondarily we will compare changes in MVPA, sedentary time, cardiovascular fitness, muscular strength, motor ability, quality of life, and the percentage of adolescents achieving the US recommendation of 60 min. MVPA/d across 18 mos. We will also explore the influence of process variables/participant characteristics on changes in MVPA across 18 mos. NCT registration: NCT03684512.",2019,We recently developed a remote system to deliver MVPA to groups of adolescents with IDD in their homes via video conferencing on a tablet computer.,"['adolescents with IDD', '114 adolescents with IDD randomized to a', 'Adolescents with intellectual and developmental disabilities (IDD', 'adolescents with intellectual and developmental disabilities']","['MVPA', 'NCT registration', 'single level intervention delivered only to the adolescent (AO) or a multi-level intervention delivered to both the adolescent and a parent (A\u202f+\u202fP']","['MVPA, sedentary time, cardiovascular fitness, muscular strength, motor ability, quality of life, and the percentage of adolescents achieving the US recommendation of 60\u202fmin', 'MVPA', 'physical activity']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C4708785', 'cui_str': 'One hundred and fourteen'}, {'cui': 'C0008073', 'cui_str': 'Child Development Disorders'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}]","[{'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0442025', 'cui_str': 'Muscular (qualifier value)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0034380'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",114.0,0.0419222,We recently developed a remote system to deliver MVPA to groups of adolescents with IDD in their homes via video conferencing on a tablet computer.,"[{'ForeName': 'L T', 'Initials': 'LT', 'LastName': 'Ptomey', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Boulevard, Kansas City, KS 66160, USA. Electronic address: lptomey@ku.edu.'}, {'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Washburn', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Boulevard, Kansas City, KS 66160, USA. Electronic address: rwashburn@ku.edu.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Educational Psychology and Leadership, Texas Tech University, 2500 Broadway, Lubbock, TX 79409, USA. Electronic address: jaehoon.lee@ttu.edu.'}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Greene', 'Affiliation': 'Department of Health, Sport, and Exercise Sciences, University of Kansas, Lawrence, KS 66045, USA. Electronic address: jlg@ku.edu.'}, {'ForeName': 'A N', 'Initials': 'AN', 'LastName': 'Szabo-Reed', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Boulevard, Kansas City, KS 66160, USA. Electronic address: aszabo@kumc.edu.'}, {'ForeName': 'J R', 'Initials': 'JR', 'LastName': 'Sherman', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Boulevard, Kansas City, KS 66160, USA. Electronic address: joesherman@ku.edu.'}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Danon', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Boulevard, Kansas City, KS 66160, USA. Electronic address: jdanon@ku.edu.'}, {'ForeName': 'L N', 'Initials': 'LN', 'LastName': 'Osborne', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Boulevard, Kansas City, KS 66160, USA. Electronic address: lnosborne@ku.edu.'}, {'ForeName': 'T D', 'Initials': 'TD', 'LastName': 'Little', 'Affiliation': 'Department of Educational Psychology and Leadership, Texas Tech University, 2500 Broadway, Lubbock, TX 79409, USA. Electronic address: todd.d.little@ttu.edu.'}, {'ForeName': 'J E', 'Initials': 'JE', 'LastName': 'Donnelly', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Boulevard, Kansas City, KS 66160, USA. Electronic address: jdonnelly@ku.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105817']
90,31870749,"Intravenous Administration of Tranexamic Acid Significantly Improved Clarity of the Visual Field in Arthroscopic Shoulder Surgery. A Prospective, Double-Blind, and Randomized Controlled Trial.","PURPOSE


To determine whether intravenous administration of tranexamic acid (TXA) before shoulder arthroscopic rotator cuff repair surgery can improve arthroscopy visual clarity.
METHODS


This was a prospective, double-blind, randomized, and placebo-controlled study. From May 2016 to April 2018, patients requiring arthroscopic rotator cuff repair were enrolled and randomly assigned to either the TXA group. receiving 1000 mg of TXA intravenously 10 minutes before surgery. or the placebo group. receiving the same volume of plain saline. Patients with pre-existing liver/renal disease, coagulopathy, or concurrent use of anticoagulation medications were excluded. Visual clarity was rated using a Numeric Rating Scale from grade 1 (poor) to grade 3 (clear) every 15 minutes throughout the surgery. Secondary outcomes included estimated perioperative blood loss, operative time, degree of shoulder swelling, postoperative subjective pain score, inpatient duration, and associated comorbidities were recorded. Both parametric and nonparametric methods were used for the statistical analysis.
RESULTS


In total, 72 patients were enrolled, 37 in the TXA group and 35 in the placebo group. The demographic data were similar between the 2 groups. Visual clarity was found to be significantly better in the TXA group, with a greater percentage of grade 3 vision clarity (53.7 ± 18.9 % vs 40.5 ± 22.1%, P = .036). The average visual score in the TXA group (2.5 ± 0.2) also was better than that of the control group (2.3 ± 0.3) (P = .048). The postoperative subjective pain score was significantly lower in the TXA group (3.0 ± 1.5) than in the control group (4.3 ± 2.0) (P = .009). In addition, postoperative analgesic usage was significant lower in the TXA groups (9.6 ± 9.7 morphine milligram equivalent) than in the control group (14.7 ± 13.4 morphine milligram equivalent) (P = .037). Other parameters, such as operative time, estimated perioperative blood loss, degree of shoulder swelling, and duration of inpatient stay were similar between the 2 groups. None of the patients developed complications after surgery.
CONCLUSIONS


Intravenous administration of TXA is an alternative way to improve visual clarity in arthroscopic shoulder surgery. It also reduces subjective pain and analgesic consumption in the early postoperative period without significant side effects.
LEVEL OF EVIDENCE


Therapeutic studies level II.",2020,"Visual clarity was found to be significantly better in the TXA group, with a greater percentage of grade 3 vision clarity (53.7 ± 18.9 % vs 40.5 ± 22.1%, P = .036).","['arthroscopic shoulder surgery', 'Patients with pre-existing liver/renal disease, coagulopathy, or concurrent use of anticoagulation medications were excluded', 'From May 2016 to April 2018, patients requiring arthroscopic rotator cuff repair', '72 patients were enrolled, 37 in the TXA group and 35 in the placebo group']","['tranexamic acid (TXA', 'Tranexamic Acid', 'placebo', 'TXA', 'plain saline']","['Visual clarity', 'operative time, estimated perioperative blood loss, degree of shoulder swelling, and duration of inpatient stay', 'average visual score', 'postoperative subjective pain score', 'visual clarity', 'postoperative analgesic usage', 'estimated perioperative blood loss, operative time, degree of shoulder swelling, postoperative subjective pain score, inpatient duration, and associated comorbidities', 'grade 3 vision clarity', 'subjective pain and analgesic consumption']","[{'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0022658', 'cui_str': 'Kidney Diseases'}, {'cui': 'C0005779', 'cui_str': 'Blood Coagulation Disorders'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0449867', 'cui_str': 'Use of anticoagulation (attribute)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0186666', 'cui_str': 'Repair of musculotendinous cuff of shoulder (procedure)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0486588', 'cui_str': 'Clarity (property) (qualifier value)'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0420496', 'cui_str': 'Duration of inpatient stay (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0457083', 'cui_str': 'Usage (attribute)'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",72.0,0.228036,"Visual clarity was found to be significantly better in the TXA group, with a greater percentage of grade 3 vision clarity (53.7 ± 18.9 % vs 40.5 ± 22.1%, P = .036).","[{'ForeName': 'Yuan-Fu', 'Initials': 'YF', 'LastName': 'Liu', 'Affiliation': 'Department of Orthopaedic Surgery, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Chih-Kai', 'Initials': 'CK', 'LastName': 'Hong', 'Affiliation': 'Department of Orthopaedic Surgery, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Kai-Lan', 'Initials': 'KL', 'LastName': 'Hsu', 'Affiliation': 'Department of Orthopaedic Surgery, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan; Department of Biomedical Engineering, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Fa-Chuan', 'Initials': 'FC', 'LastName': 'Kuan', 'Affiliation': 'Department of Orthopaedic Surgery, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan; Department of Biomedical Engineering, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Yueh', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Orthopaedic Surgery, Sin Lau Christian Hospital, Tainan, Taiwan.'}, {'ForeName': 'Ming-Long', 'Initials': 'ML', 'LastName': 'Yeh', 'Affiliation': 'Department of Biomedical Engineering, National Cheng Kung University, Tainan, Taiwan; Medical Device Innovation Center, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Wei-Ren', 'Initials': 'WR', 'LastName': 'Su', 'Affiliation': 'Department of Orthopaedic Surgery, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan; Skeleton Materials and Bio-compatibility Core Lab, Research Center of Clinical Medicine, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan. Electronic address: suwr@ms28.hinet.net.'}]",Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association,['10.1016/j.arthro.2019.10.020']
91,31874733,Exercise-based injury prevention for community-level adolescent cricket pace bowlers: A cluster-randomised controlled trial.,"OBJECTIVES


To investigate if an exercise-based injury prevention program (IPP) can modify risk factors for injury in community-level adolescent cricket pace bowlers.
DESIGN


Cluster-randomised controlled trial.
METHODS


Eight cricket organisations (training two times per week and no previous involvement in a structured IPP) participated in this cluster-randomised trial. Participants were aged 14-17 years, injury free, and not currently performing a rehabilitation/exercise program. Cricket organisations (clusters) were block-randomised by computerised number generation into an intervention group (performed an eight-week IPP at training) or control group (continued their usual cricket activity). Participants were not blinded to group allocation. Strength, endurance, and neuromuscular control were assessed at baseline and follow-up. Treatment effects were estimated using linear mixed models.
RESULTS


Sixty-five male adolescent pace bowlers (intervention n=32 and control n=33) were randomised. There were significant treatment effects favouring the intervention group for shoulder strength (90°/s) 0.05 (95% CI 0.02-0.09) Nm/kg, hamstring strength (60°/s) 0.32 (95% CI 0.13-0.50) Nm/kg, hip adductor strength dominant 0.40 (95% CI 0.26-0.55) Nm/kg and non-dominant 0.33 (95% CI 0.20-0.47) Nm/kg, SEBT reach distance dominant 3.80 (95% CI 1.63-6.04) percent of leg length (%LL) and non-dominant 3.60 (95% CI 1.43-5.78) %LL, and back endurance 20.4 (95% CI 4.80-36.0) seconds. No differences were observed for shoulder strength (180°/s) (p=0.09), hamstring strength (180°/s) (p=0.07), lumbopelvic stability (p=0.90), and single leg squat knee valgus angle (dominant p=0.06, non-dominant p=0.15).
CONCLUSIONS


Exercise-based IPPs can modify risk factors for injury in community-level adolescent pace bowlers. Future research is needed to confirm if IPPs can also reduce injury risk in this population.",2020,There were significant treatment effects favouring the intervention group for shoulder strength (90°/s) 0.05,"['community-level adolescent cricket pace bowlers', 'Participants were aged 14-17 years, injury free, and not currently performing a rehabilitation/exercise program', 'Sixty-five male adolescent pace bowlers (intervention n=32 and control n=33']","['Exercise-based injury prevention', 'cricket organisations (training two times per week and no previous involvement in a structured IPP', 'exercise-based injury prevention program (IPP', 'Exercise-based IPPs']","['lumbopelvic stability', 'Nm/kg, hamstring strength', 'Strength, endurance, and neuromuscular control', 'shoulder strength', 'single leg squat knee valgus angle', 'leg length', 'Nm/kg, hip adductor strength', 'hamstring strength']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0018288', 'cui_str': 'Crickets'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0450385', 'cui_str': '65 (qualifier value)'}, {'cui': 'C0001589', 'cui_str': 'Adolescents, Male'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0150638', 'cui_str': 'Preventing injury (procedure)'}, {'cui': 'C0018288', 'cui_str': 'Crickets'}, {'cui': 'C0029237', 'cui_str': 'Organization (morphologic abnormality)'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0205428', 'cui_str': 'Involvements (qualifier value)'}, {'cui': 'C0063506', 'cui_str': 'IPP'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0241236', 'cui_str': 'Does squat (finding)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0443344', 'cui_str': 'Valgus (qualifier value)'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0426952', 'cui_str': 'Leg length (observable entity)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}]",65.0,0.17759,There were significant treatment effects favouring the intervention group for shoulder strength (90°/s) 0.05,"[{'ForeName': 'Mitchell R L', 'Initials': 'MRL', 'LastName': 'Forrest', 'Affiliation': 'College of Science, Health, Engineering and Education, Murdoch University, Australia; Murdoch Applied Sports Science Laboratory, Murdoch University, Australia. Electronic address: Mitch.Forrest@murdoch.edu.au.'}, {'ForeName': 'Jeffrey J', 'Initials': 'JJ', 'LastName': 'Hebert', 'Affiliation': 'College of Science, Health, Engineering and Education, Murdoch University, Australia; Faculty of Kinesiology, University of New Brunswick, Canada.'}, {'ForeName': 'Brendan R', 'Initials': 'BR', 'LastName': 'Scott', 'Affiliation': 'College of Science, Health, Engineering and Education, Murdoch University, Australia; Murdoch Applied Sports Science Laboratory, Murdoch University, Australia.'}, {'ForeName': 'Alasdair R', 'Initials': 'AR', 'LastName': 'Dempsey', 'Affiliation': 'College of Science, Health, Engineering and Education, Murdoch University, Australia; Murdoch Applied Sports Science Laboratory, Murdoch University, Australia.'}]",Journal of science and medicine in sport,['10.1016/j.jsams.2019.12.009']
92,32333407,Exploration of suitable pharmacodynamic parameters for acarbose bioequivalence evaluation: A series of clinical trials with branded acarbose.,"AIMS


To determine deficiencies in the Food and Drug Administration (FDA)'s guidance for assessing acarbose bioequivalence (BE) and to explore optimal pharmacodynamic (PD) metrics for better evaluation of acarbose BE.
METHODS


Three clinical trials with branded acarbose were conducted in healthy subjects, including a pilot study (Study I, n = 11, 50 and 100 mg), a 2×2 crossover BE study (Study II, n = 36, 100 mg) and a 4×4 Williams study (Study III, n = 16, 50/100/150 mg). Serum glucose concentrations were measured by the glucose oxidase method.
RESULTS


In Study I, compared with 50 mg acarbose, only 100 mg acarbose had a significantly lower C max0-4h  than that of sucrose administration alone (7.96 ± 0.83 mmol/L vs 6.78 ± 1.02 mmol/L, P < .05). In Study II, the geometric mean ratios of the test formulation to the reference formulation (both formulations were the branded drug) for FDA PD metrics, ΔC max0-4h  and ΔAUC 0-4h  , were 0.903 and 0.776, respectively, and the 90% confidence intervals were 67.44-120.90 and 53.65-112.13, respectively. The geometric mean ratios (confidence interval) for possible optimal evaluation PD metrics (C max0-2h  and AUC 0-2h  ) were 1.035 (94.23-112.68) and 0.982 (89.28-107.17), respectively. Further, C max0-2h  and AUC 0-2h  also met the sensitivity requirements for BE evaluation in Study III.
CONCLUSION


Considering the mechanisms of action of acarbose, the PD effect was shown to be dose independent during the 2-4 hours postadministration of acarbose. Hence PD metrics based on the serum glucose concentration from 0 to 2 hours (C max0-2h  and AUC 0-2h  ) are more sensitive than the FDA-recommended PD metrics for acarbose BE evaluation from 0-4 hours (ΔC max0-4h  and ΔAUC 0-4h  ). The trial has been registered at the Chinese Clinical Trial Registry (http://www.chictr.org.cn, ChiCTR1800015795, ChiCTR-IIR-17013918, ChiCTR-IIR-17011903). All subjects provided written informed consent before screening.",2020,"In Study I, compared with 50 mg acarbose, only 100 mg acarbose had a significantly lower C max0-4h  than that of sucrose administration alone (7.96±0.83 mmol/",['healthy subjects'],"['branded acarbose', 'acarbose']","['serum glucose concentration', 'geometric mean ratios (GMRs', 'Serum glucose concentrations']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0050393', 'cui_str': 'Acarbose'}]","[{'cui': 'C0202041', 'cui_str': 'Glucose measurement, serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",,0.0338336,"In Study I, compared with 50 mg acarbose, only 100 mg acarbose had a significantly lower C max0-4h  than that of sucrose administration alone (7.96±0.83 mmol/","[{'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Wen-Yu', 'Initials': 'WY', 'LastName': 'Liu', 'Affiliation': 'Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Jing-Jing', 'Initials': 'JJ', 'LastName': 'Yu', 'Affiliation': 'Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Jin-Bo', 'Initials': 'JB', 'LastName': 'Yang', 'Affiliation': 'Centre for Drug Evaluation, National Medical Products Administration, Beijing, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Centre for Drug Evaluation, National Medical Products Administration, Beijing, China.'}, {'ForeName': 'Chan', 'Initials': 'C', 'LastName': 'Zou', 'Affiliation': 'Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Cheng-Xian', 'Initials': 'CX', 'LastName': 'Guo', 'Affiliation': 'Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Xiao-Yan', 'Initials': 'XY', 'LastName': 'Yang', 'Affiliation': 'Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': 'Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Jin-Lian', 'Initials': 'JL', 'LastName': 'Xie', 'Affiliation': 'Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Zhi-Jun', 'Initials': 'ZJ', 'LastName': 'Huang', 'Affiliation': 'Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Clinc Lab Center, The Third Xiangya Hospital of Central South University, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Pei', 'Affiliation': 'Department of Pharmacy, the Third Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Guo-Ping', 'Initials': 'GP', 'LastName': 'Yang', 'Affiliation': 'Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University, Changsha, Hunan, China.'}]",British journal of clinical pharmacology,['10.1111/bcp.14324']
93,32392169,A randomised comparison of monoplane versus biplane fluoroscopy in patients undergoing percutaneous coronary intervention: the RAMBO trial.,"AIMS


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


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


Biplane imaging for coronary angiography and PCI is related to an increased radiation exposure for the interventional cardiologist as compared with monoplane imaging. Monoplane imaging should be considered for advanced radioprotection in cardiac catheterisation, with biplane imaging used for selected cases only. Visual summary. RAdiation exposure in Monoplane versus Biplane percutaneous cOronary angiography and interventions: the RAMBO trial.",2020,"While fluoroscopy time did not differ among groups (p=0.89), the amount of contrast medium was lower with biplane as compared with monoplane imaging (p&lt;0.001).
",['430 patients undergoing coronary angiography'],"['biplane or monoplane imaging', 'RAMBO (RAdiation exposure in Monoplane versus Biplane cOronary angiography and interventions', 'biplane versus monoplane coronary angiography and percutaneous coronary interventions (PCI', 'RAdiation exposure in Monoplane versus Biplane percutaneous cOronary angiography and interventions']","['amount of contrast medium', 'fluoroscopy time', 'operator radiation dose at the level of the left arm as measured by a wearable electronic dosimeter']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}]","[{'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0015333', 'cui_str': 'Exposure to radiation'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}]","[{'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0230347', 'cui_str': 'Left upper arm structure'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0180488', 'cui_str': 'Dosimeter'}]",430.0,0.0355147,"While fluoroscopy time did not differ among groups (p=0.89), the amount of contrast medium was lower with biplane as compared with monoplane imaging (p&lt;0.001).
","[{'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Leistner', 'Affiliation': 'Department of Cardiology, Charité Berlin - University Medicine, Campus Benjamin Franklin, Berlin, and DZHK (German Centre for Cardiovascular Research), partner site Berlin, Berlin, Germany.'}, {'ForeName': 'Lara S', 'Initials': 'LS', 'LastName': 'Schlender', 'Affiliation': ''}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Steiner', 'Affiliation': ''}, {'ForeName': 'Aslihan', 'Initials': 'A', 'LastName': 'Erbay', 'Affiliation': ''}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Klotsche', 'Affiliation': ''}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Schauerte', 'Affiliation': ''}, {'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Haghikia', 'Affiliation': ''}, {'ForeName': 'Ursula', 'Initials': 'U', 'LastName': 'Rauch-Kröhnert', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Sinning', 'Affiliation': ''}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Lauten', 'Affiliation': ''}, {'ForeName': 'Hans-Christian', 'Initials': 'HC', 'LastName': 'Mochmann', 'Affiliation': ''}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Skurk', 'Affiliation': ''}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Landmesser', 'Affiliation': ''}, {'ForeName': 'Barbara E', 'Initials': 'BE', 'LastName': 'Stähli', 'Affiliation': ''}]",EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology,['10.4244/EIJ-D-20-00217']
94,32334541,Life review therapy for holocaust survivors (LRT-HS): study protocol for a randomised controlled trial.,"BACKGROUND


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


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


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


ISRCTN, ISRCTN12823306. Registered 31 March 2018 - Retrospectively registered (first participant 22 December 2017).",2020,A narrative approach including life-review and narrative exposure seems to meet very well the natural need of older people to review their lives and is highly effective.,"['young and middle-aged adults', 'holocaust survivors (LRT-HS', 'Holocaust survivors with one or more trauma-related disorders', 'older individuals']","['LRT', 'life review therapy (LRT']","['symptoms of PTSD and related mental health problems (depression, anxiety, prolonged grief']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0206236', 'cui_str': 'Holocaust'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C1446377', 'cui_str': 'Mental health problem'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0018235', 'cui_str': 'Normal grief reaction'}]",,0.101681,A narrative approach including life-review and narrative exposure seems to meet very well the natural need of older people to review their lives and is highly effective.,"[{'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Forstmeier', 'Affiliation': 'Developmental Psychology and Clinical Psychology over the Lifespan, Institute of Psychology, University of Siegen, Adolf-Reichwein-Str. 2a, 57068, Siegen, Germany. simon.forstmeier@uni-siegen.de.'}, {'ForeName': 'Elisheva', 'Initials': 'E', 'LastName': 'van der Hal', 'Affiliation': 'Amcha, The National Israeli Center for Psychosocial Support of Survivors of the Holocaust and the Second Generation, 23 Hillel Str., P.O. Box 2930, 91029, Jerusalem, Israel.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Auerbach', 'Affiliation': 'Amcha, The National Israeli Center for Psychosocial Support of Survivors of the Holocaust and the Second Generation, 23 Hillel Str., P.O. Box 2930, 91029, Jerusalem, Israel.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Maercker', 'Affiliation': 'Psychopathology and Clinical Interventions, Department of Psychology, University of Zurich, Binzmuehlestr. 14/17, 8050, Zurich, Switzerland.'}, {'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'Brom', 'Affiliation': 'Herzog Hospital, Givat Shaul St, 91035, Jerusalem, Israel.'}]",BMC psychiatry,['10.1186/s12888-020-02600-5']
95,32337679,"Sensory and motor responses after photobiomodulation associated with physiotherapy in patients with incomplete spinal cord injury: clinical, randomized trial.","Complete or incomplete spinal cord injury (SCI) results in permanent neurological deficits due to the interruption of nerve impulses, causing the loss of motor and sensory function, which leads to a reduction in quality of life. The focus of rehabilitation for such individuals is to improve quality of life and promote functional recovery. Photobiomodulation (PBM) has proved to be promising complementary treatment in cases of SCI. The aim of the present study was to investigate the effects of PBM combined with physiotherapy on sensory-motor responses below the level of the injury and quality of life in individuals with SCI. Thirty participants were randomized for allocation to the PBM group (active PBM + physiotherapy) or sham group (sham PBM + physiotherapy). Physiotherapy was administered three times a week. Sensitivity and motor skills were evaluated using the ASIA impairment scale. Quality of life was assessed using the WHOQOL-BREF questionnaire. The data were analyzed with the level of significance set to 5%. Improvements in sensitivity and an increase in the perception of muscle contraction were found in the active PBM group 30 days after treatment compared with the sham group. The results of the WHOQOL-BREF questionnaire revealed a significant difference in general quality of life favoring the active PBM group over the sham group after treatment. Physiotherapy combined with PBM leads to better sensory-motor recovery in patients with SCI as well as a better perception of health and quality of life. Trial registration identifier: NCT03031223.",2020,Improvements in sensitivity and an increase in the perception of muscle contraction were found in the active PBM group 30 days after treatment compared with the sham group.,"['patients with SCI', 'Thirty participants', 'individuals with SCI', 'patients with incomplete spinal cord injury']","['PBM combined with physiotherapy', 'PBM group (active PBM + physiotherapy) or sham group (sham PBM + physiotherapy', 'Photobiomodulation (PBM', 'Physiotherapy combined with PBM', 'physiotherapy']","['Sensory and motor responses', 'Quality of life', 'WHOQOL-BREF questionnaire', 'perception of health and quality of life', 'quality of life and promote functional recovery', 'sensory-motor responses', 'ASIA impairment scale', 'perception of muscle contraction', 'general quality of life', 'Sensitivity and motor skills']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4545488', 'cui_str': 'Incomplete spinal cord injury'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C1285623', 'cui_str': 'Motor response'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0599766', 'cui_str': 'Recovery of Function'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0026820', 'cui_str': 'Muscle contraction'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0026612', 'cui_str': 'Motor Skills'}]",30.0,0.0764164,Improvements in sensitivity and an increase in the perception of muscle contraction were found in the active PBM group 30 days after treatment compared with the sham group.,"[{'ForeName': 'Fernanda Cordeiro', 'Initials': 'FC', 'LastName': 'da Silva', 'Affiliation': 'Universidade Nove de Julho, Rua Vergueiro, 235/249 - Liberdade, São Paulo, SP, Brazil.'}, {'ForeName': 'Tamiris', 'Initials': 'T', 'LastName': 'Silva', 'Affiliation': 'Universidade Nove de Julho, Rua Vergueiro, 235/249 - Liberdade, São Paulo, SP, Brazil.'}, {'ForeName': 'Andréa Oliver', 'Initials': 'AO', 'LastName': 'Gomes', 'Affiliation': 'Universidade Nove de Julho, Rua Vergueiro, 235/249 - Liberdade, São Paulo, SP, Brazil.'}, {'ForeName': 'Paulo Roberto', 'Initials': 'PR', 'LastName': 'da Costa Palácio', 'Affiliation': 'Universidade Nove de Julho, Rua Vergueiro, 235/249 - Liberdade, São Paulo, SP, Brazil.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Andreo', 'Affiliation': 'Universidade Nove de Julho, Rua Vergueiro, 235/249 - Liberdade, São Paulo, SP, Brazil.'}, {'ForeName': 'Marcela Leticia Leal', 'Initials': 'MLL', 'LastName': 'Gonçalves', 'Affiliation': 'Universidade Nove de Julho, Rua Vergueiro, 235/249 - Liberdade, São Paulo, SP, Brazil.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Fátima Teixeira Silva', 'Affiliation': 'Universidade Nove de Julho, Rua Vergueiro, 235/249 - Liberdade, São Paulo, SP, Brazil.'}, {'ForeName': 'Anna Carolina Ratto Tempestini', 'Initials': 'ACRT', 'LastName': 'Horliana', 'Affiliation': 'Universidade Nove de Julho, Rua Vergueiro, 235/249 - Liberdade, São Paulo, SP, Brazil.'}, {'ForeName': 'Lara Jansiski', 'Initials': 'LJ', 'LastName': 'Motta', 'Affiliation': 'Universidade Nove de Julho, Rua Vergueiro, 235/249 - Liberdade, São Paulo, SP, Brazil.'}, {'ForeName': 'Raquel Agnelli', 'Initials': 'RA', 'LastName': 'Mesquita-Ferrari', 'Affiliation': 'Universidade Nove de Julho, Rua Vergueiro, 235/249 - Liberdade, São Paulo, SP, Brazil.'}, {'ForeName': 'Kristianne Porta Santos', 'Initials': 'KPS', 'LastName': 'Fernandes', 'Affiliation': 'Universidade Nove de Julho, Rua Vergueiro, 235/249 - Liberdade, São Paulo, SP, Brazil.'}, {'ForeName': 'Sandra Kalil', 'Initials': 'SK', 'LastName': 'Bussadori', 'Affiliation': 'Universidade Nove de Julho, Rua Vergueiro, 235/249 - Liberdade, São Paulo, SP, Brazil. sandra_skb@gmail.com.'}]",Lasers in medical science,['10.1007/s10103-020-02968-6']
96,32305457,"Translating research into practice: Protocol for a community-engaged, stepped wedge randomized trial to reduce disparities in breast cancer treatment through a regional patient navigation collaborative.","BACKGROUND


Racial and socioeconomic disparities in breast cancer mortality persist. In Boston, MA, Black, Non-Hispanic women and Medicaid-insured individuals are 2-3 times more likely to have delays in treatment compared to White or privately insured women. While evidence-based care coordination strategies for reducing delays exist, they are not systematically implemented across healthcare settings.
METHODS


Translating Research Into Practice (TRIP) utilizes community engaged research methods to address breast cancer care delivery disparities. Four Massachusetts Clinical and Translational Science Institute (CTSI) hubs collaborated with the Boston Breast Cancer Equity Coalition (The Coalition) to implement an evidence-based care coordination intervention for Boston residents at risk for delays in breast cancer care. The Coalition used a community-driven process to define the problem of care delivery disparities, identify the target population, and develop a rigorous pragmatic approach. We chose a cluster-randomized, stepped-wedge hybrid type I effectiveness-implementation study design. The intervention implements three evidence-based strategies: patient navigation services, a shared patient registry for use across academic medical centers, and a web-based social determinants of health platform to identify and address barriers to care. Primary clinical outcomes include time to first treatment and receipt of guideline-concordant treatment, which are captured through electronic health records abstraction. We will use mixed methods to collect the secondary implementation outcomes of acceptability, adoption/penetration, fidelity, sustainability and cost.
CONCLUSION


TRIP utilizes an innovative community-driven research strategy, focused on interdisciplinary collaborations, to design and implement a translational science study that aims to more efficiently integrate proven health services interventions into clinical practice.",2020,"The intervention implements three evidence-based strategies: patient navigation services, a shared patient registry for use across academic medical centers, and a web-based social determinants of health platform to identify and address barriers to care.",[],['stepped-wedge hybrid type'],"['time to first treatment and receipt of guideline-concordant treatment, which are captured through electronic health records abstraction', 'acceptability, adoption/penetration, fidelity, sustainability and cost']",[],"[{'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439639', 'cui_str': 'Wedge'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0001593', 'cui_str': 'Adoption'}, {'cui': 'C0205321', 'cui_str': 'Penetrating'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",,0.050151,"The intervention implements three evidence-based strategies: patient navigation services, a shared patient registry for use across academic medical centers, and a web-based social determinants of health platform to identify and address barriers to care.","[{'ForeName': 'Tracy A', 'Initials': 'TA', 'LastName': 'Battaglia', 'Affiliation': ""Women's Health Unit, Section of General Internal Medicine, Boston University School of Medicine, Boston, MA, United States of America. Electronic address: Tracy.Battaglia@bmc.org.""}, {'ForeName': 'Karen M', 'Initials': 'KM', 'LastName': 'Freund', 'Affiliation': 'Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, MA, United States of America; Division of Internal Medicine and Primary Care, Department of Medicine, Tufts Medical Center, Boston, MA, United States of America; Tufts University School of Medicine, Boston, MA, United States of America.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Haas', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States of America.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Casanova', 'Affiliation': ""Women's Health Unit, Section of General Internal Medicine, Boston University School of Medicine, Boston, MA, United States of America.""}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Bak', 'Affiliation': ""Women's Health Unit, Section of General Internal Medicine, Boston University School of Medicine, Boston, MA, United States of America; Boston University School of Medicine, Boston, MA, United States of America.""}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Cabral', 'Affiliation': 'Department of Biostatistics, Boston University School of Public Health, Boston, MA, United States of America.'}, {'ForeName': 'Rachel A', 'Initials': 'RA', 'LastName': 'Freedman', 'Affiliation': 'Department of Medical Oncology, Dana Farber Cancer Institute, Boston, MA, United States of America.'}, {'ForeName': 'Karen Burns', 'Initials': 'KB', 'LastName': 'White', 'Affiliation': 'Initiative to Eliminate Cancer Disparities, Dana Farber/Harvard Cancer Center, Boston, MA, United States of America.'}, {'ForeName': 'Stephenie C', 'Initials': 'SC', 'LastName': 'Lemon', 'Affiliation': 'Division of Preventive and Behavioral Medicine, University of Massachusetts Medical School, Worcester, MA, United States of America.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Contemporary clinical trials,['10.1016/j.cct.2020.106007']
97,32229324,Neurocognitive processes in d-cycloserine augmented single-session exposure therapy for anxiety: A randomized placebo-controlled trial.,"Drugs targeting N-methyl-d-aspartate (NMDA) receptors and the ability to learn new associations have been proposed as adjunct treatments to boost the success of exposure therapy for anxiety disorders. However, the effects of the NMDA partial agonist d-cycloserine on psychological treatment have been mixed. We investigated potential neurocognitive mechanisms underlying the clinical effects of d-cycloserine-augmented exposure, to inform the optimal combination of this and similar agents with psychological treatment. Panic disorder patients were randomised to single-dose d-cycloserine (250 mg; N = 17) or matching placebo (N = 16) 2hrs before one session of exposure therapy. Neurocognitive markers were assessed one day after treatment, including reaction-time based threat bias for fearful faces (primary outcome) and amygdala response to threat (secondary outcome). Clinical symptom severity was measured the day before and after treatment, and at 1- and 6-months follow-up (secondary outcome). d-cycloserine was associated with greater clinical recovery at 1-month follow-up than placebo (d-cyloserine 71% vs placebo 25%), with the placebo group matching the clinical gains of the d-cycloserine group during 6-months follow-up (d-cycloserine 71% vs placebo 44%). One day after treatment, threat bias for fearful faces and amygdala threat response was lower in the drug compared to placebo group. Lower amygdala magnitude predicted greater clinical improvement during follow-up across groups. While this experimental study is of a preliminary nature due to the limited sample size, these findings highlight a neurocognitive potential mechanism by which d-cycloserine may exert its augmentative effects on psychological treatment and bring forward a marker that may help understand and facilitate development of combination treatments for anxiety. (d-cycloserine Augmented CBT for Panic Disorder; clinicaltrials.gov; NCT01680107).",2020,"One day after treatment, threat bias for fearful faces and amygdala threat response was lower in the drug compared to placebo group.","['Panic disorder patients', 'anxiety']","['placebo', 'matching placebo', 'cycloserine augmented single-session exposure therapy', 'NMDA partial agonist d-cycloserine', 'single-dose d-cycloserine']","['threat bias for fearful faces and amygdala threat response', 'Clinical symptom severity', 'clinical recovery', 'reaction-time based threat bias for fearful faces (primary outcome) and amygdala response to threat (secondary outcome', 'Neurocognitive markers', 'Neurocognitive processes']","[{'cui': 'C0030319', 'cui_str': 'Panic Disorder'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0010590', 'cui_str': 'Cycloserine'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}, {'cui': 'C0079883', 'cui_str': 'N-Methyl-D-aspartate'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C0005346', 'cui_str': 'Bias'}, {'cui': 'C0458278', 'cui_str': 'Fearful (qualifier value)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid Body'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}]",,0.358042,"One day after treatment, threat bias for fearful faces and amygdala threat response was lower in the drug compared to placebo group.","[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Reinecke', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK. Electronic address: andrea.reinecke@psych.ox.ac.uk.'}, {'ForeName': 'Alecia', 'Initials': 'A', 'LastName': 'Nickless', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK; School of Chemistry, University of Bristol, Bristol, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Browning', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK; Oxford Health NHS Foundation Trust, Warneford Hospital, Oxford, UK.'}, {'ForeName': 'Catherine J', 'Initials': 'CJ', 'LastName': 'Harmer', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK; Oxford Health NHS Foundation Trust, Warneford Hospital, Oxford, UK.'}]",Behaviour research and therapy,['10.1016/j.brat.2020.103607']
98,32232363,Acute Effects of Glucagon on Reproductive Hormone Secretion in Healthy Men.,"CONTEXT


Glucagon increases energy expenditure; consequently, glucagon receptor agonists are in development for the treatment of obesity. Obesity negatively affects the reproductive axis, and hypogonadism itself can exacerbate weight gain. Therefore, knowledge of the effects of glucagon receptor agonism on reproductive hormones is important for developing therapeutics for obesity; but reports in the literature about the effects of glucagon receptor agonism on the reproductive axis are conflicting.
OBJECTIVE


The objective of this work is to investigate the effect of glucagon administration on reproductive hormone secretion in healthy young men.
DESIGN


A single-blinded, randomized, placebo-controlled crossover study was conducted.
SETTING


The setting of this study was the Clinical Research Facility, Imperial College Healthcare NHS Trust.
PARTICIPANTS


Eighteen healthy eugonadal men (mean ± SEM: age 25.1 ± 1.0 years; body mass index 22.5 ± 0.4 kg/m2; testosterone 21.2 ± 1.2 nmol/L) participated in this study.
INTERVENTION


An 8-hour intravenous infusion of 2 pmol/kg/min glucagon or rate-matched vehicle infusion was administered.
MAIN OUTCOME MEASURES


Luteinizing hormone (LH) pulsatility; LH, follicle-stimulating hormone (FSH), and testosterone levels were measured.
RESULTS


Although glucagon administration induced metabolic effects (insulin area under the curve: vehicle 1065 ± 292 min.µU/mL vs glucagon 2098 ± 358 min.µU/mL, P < .001), it did not affect LH pulsatility (number of LH pulses/500 min: vehicle 4.7 ± 0.4, glucagon 4.2 ± 0.4, P = .22). Additionally, there were no significant differences in circulating LH, FSH, or testosterone levels during glucagon administration compared with vehicle administration.
CONCLUSIONS


Acute administration of a metabolically active dose of glucagon does not alter reproductive hormone secretion in healthy men. These data are important for the continued development of glucagon-based treatments for obesity.",2020,"Although glucagon administration induced metabolic effects (insulin AUC: vehicle 1065±292min.µU/mL vs glucagon 2098±358min.µU/mL, p<0.0001), it did not affect LH pulsatility (number of LH pulses/500min: vehicle 4.7±0.4, glucagon 4.2±0.4, p=0.22).","['Healthy Men', 'Eighteen healthy eugonadal men (mean±SEM', 'healthy men', 'healthy young men']","['placebo', 'glucagon receptor agonism', 'glucagon administration', '2pmol/kg/min glucagon or rate-matched vehicle infusion', 'Glucagon', 'glucagon']","['circulating LH, FSH or testosterone levels', 'LH pulsatility', 'Reproductive Hormone Secretion', 'metabolic effects', 'reproductive hormone secretion', 'Luteinizing hormone (LH) pulsatility; LH, follicle stimulating hormone (FSH) and testosterone levels']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0061352', 'cui_str': 'Glucagon Receptor'}, {'cui': 'C0876232', 'cui_str': 'glucagon recombinant'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C1532757', 'cui_str': 'kg/min'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle (substance)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0733758', 'cui_str': 'Follicle Stimulating Hormone'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C0577317', 'cui_str': 'Pulsatility (attribute)'}, {'cui': 'C1167871', 'cui_str': 'Reproductive hormone'}, {'cui': 'C0036537', 'cui_str': 'Secretions'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0023607', 'cui_str': 'Luteinizing Hormone'}]",18.0,0.287042,"Although glucagon administration induced metabolic effects (insulin AUC: vehicle 1065±292min.µU/mL vs glucagon 2098±358min.µU/mL, p<0.0001), it did not affect LH pulsatility (number of LH pulses/500min: vehicle 4.7±0.4, glucagon 4.2±0.4, p=0.22).","[{'ForeName': 'Chioma', 'Initials': 'C', 'LastName': 'Izzi-Engbeaya', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Jones', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Yoshibye', 'Initials': 'Y', 'LastName': 'Crustna', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Pratibha C', 'Initials': 'PC', 'LastName': 'Machenahalli', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Papadopoulou', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Manish', 'Initials': 'M', 'LastName': 'Modi', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Starikova', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Chan', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Pei Chia', 'Initials': 'PC', 'LastName': 'Eng', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Phylactou', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Risheka', 'Initials': 'R', 'LastName': 'Ratnasabapathy', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Edouard', 'Initials': 'E', 'LastName': 'Mills', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Pacuszka', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Bech', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, London, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Minnion', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, London, UK.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Tharakan', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Tricia', 'Initials': 'T', 'LastName': 'Tan', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Veldhuis', 'Affiliation': 'Department of Internal Medicine, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Abbara', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Alexander N', 'Initials': 'AN', 'LastName': 'Comninos', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Waljit S', 'Initials': 'WS', 'LastName': 'Dhillo', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, London, UK.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa164']
99,31152463,Adolescents' Engagement with Crisis Hotline Risk-management Services: A Report from the Emergency Department Screen for Teen Suicide Risk (ED-STARS) Study.,"OBJECTIVE


This study examines the feasibility of a risk-management protocol for adolescent research participants at risk for suicide that relies on engagement with telephone crisis counselors. The study also examines whether engagement is moderated by adolescent demographics and clinical characteristics.
METHOD


Participants were 234 adolescents (83% female; 63% White) ages 12-18 (M = 15.3 years) drawn from the national study, Emergency Department Screen for Teens at Risk for Suicide (ED-STARS) Study One sample of adolescents randomized for 3-month telephone follow-up (n = 2,850). This study's sample was comprised of adolescents who completed the follow-up (69% retention), met study risk criteria, and were transferred to a crisis hotline for risk management. Engagement with a counselor was assessed by successful call connection, call duration, and information sharing.
RESULTS


Ninety-four percent of calls resulted in a successful call transfer, and the majority of youth (84%) shared information with counselor about one or more coping strategies. Average call length was 12.6 min (SD = 9.9). Engagement did not vary by gender, race, age, ethnicity, or clinical characteristics.
CONCLUSIONS


Adolescents' engagement with telephone risk-management services was strong, suggesting that this strategy can address safety. Further, findings suggest telephone risk-management services effectively engage youth across demographic and clinical subgroups.",2020,This study examines the feasibility of a risk-management protocol for adolescent research participants at risk for suicide that relies on engagement with telephone crisis counselors.,"['adolescent research participants at risk for suicide that relies on engagement with telephone crisis counselors', ""Adolescents' Engagement with Crisis Hotline Risk-management Services"", 's sample was comprised of adolescents who completed the follow-up (69% retention), met study risk criteria, and were transferred to a crisis hotline for risk management', 'Participants were 234 adolescents (83% female; 63% White) ages 12-18 (M\xa0=\xa015.3\xa0years) drawn from the national study, Emergency Department Screen for Teens at Risk for Suicide (ED-STARS', 'Study One sample of adolescents randomized for 3-month telephone follow-up (n\xa0=\xa02,850']",['risk-management protocol'],"['successful call transfer', 'successful call connection, call duration, and information sharing', 'Average call length']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0035168'}, {'cui': 'C0563664', 'cui_str': 'Suicide risk'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C4708572', 'cui_str': 'Crisis counselor'}, {'cui': 'C0231224', 'cui_str': 'Crisis (finding)'}, {'cui': 'C0020042', 'cui_str': 'Telephone Hotlines'}, {'cui': 'C0035649', 'cui_str': 'Risk Management'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517578', 'cui_str': '15.3'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0013113', 'cui_str': 'Drawing'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1521910', 'cui_str': 'Teens'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0178941', 'cui_str': 'Telephone follow-up'}]","[{'cui': 'C0035649', 'cui_str': 'Risk Management'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0449379', 'cui_str': 'Connection (attribute)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C2713449', 'cui_str': 'Information Sharing'}, {'cui': 'C1444754', 'cui_str': 'Length property'}]",,0.0536388,This study examines the feasibility of a risk-management protocol for adolescent research participants at risk for suicide that relies on engagement with telephone crisis counselors.,"[{'ForeName': 'Danielle R', 'Initials': 'DR', 'LastName': 'Busby', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Cheryl A', 'Initials': 'CA', 'LastName': 'King', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Brent', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, PA.'}, {'ForeName': 'Jaqueline', 'Initials': 'J', 'LastName': 'Grupp-Phelan', 'Affiliation': 'Department of Emergency Medicine, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Madelyn', 'Initials': 'M', 'LastName': 'Gould', 'Affiliation': 'Department of Psychiatry, Columbia University, New York, NY, USA.'}, {'ForeName': 'Kent', 'Initials': 'K', 'LastName': 'Page', 'Affiliation': 'School of Medicine, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Theron Charles', 'Initials': 'TC', 'LastName': 'Casper', 'Affiliation': 'School of Medicine, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Suicide & life-threatening behavior,['10.1111/sltb.12558']
100,32338756,Dietary Intake and Biomarkers of Folate and Cobalamin Status in Norwegian Preschool Children: The FINS-KIDS Study.,"BACKGROUND


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


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


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


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


The Norwegian preschool children from this cohort had adequate vitamin B-12 status. Poor folate status was common and associated with elevated tHcy. The implications of poor folate status during childhood should be a prioritized research question. This trial was registered at ClinicalTrials.gov as NCT02331667.",2020,Children who consumed vitamin supplements had 51% higher plasma folate concentrations (P < 0.0001) than those who did not.,"['Norwegian preschool children', 'healthy Norwegian children', 'Norwegian Preschool Children', 'children aged 4-6 y']","['vitamin supplements', 'Folate and cobalamin (vitamin B-12']","['Plasma folate concentrations', 'Consumption of red meat', 'plasma folate concentrations', 'Plasma folate concentration', 'Poor folate status', 'Food-frequency questionnaires (FFQs', 'median (IQR) of plasma folate', 'plasma folate', 'Dietary Intake and Biomarkers of Folate and Cobalamin Status', 'cobalamin concentration', 'elevated tHcy concentrations', 'elevated plasma MMA concentrations', 'plasma concentrations of folate, cobalamin, total plasma homocysteine (tHcy), and methylmalonic acid (MMA']","[{'cui': 'C0028424', 'cui_str': 'Norwegian language'}, {'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0301532', 'cui_str': 'Multivitamin preparation'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C0042845', 'cui_str': 'Vitamin B 12'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0452848', 'cui_str': 'Red meat'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0042845', 'cui_str': 'Vitamin B 12'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0019878', 'cui_str': 'Homocysteine'}, {'cui': 'C0025787', 'cui_str': 'Methyl malonic acid'}]",2.0,0.0824589,Children who consumed vitamin supplements had 51% higher plasma folate concentrations (P < 0.0001) than those who did not.,"[{'ForeName': 'Beate S', 'Initials': 'BS', 'LastName': 'Solvik', 'Affiliation': 'Innlandet Hospital Trust, Lillehammer, Norway.'}, {'ForeName': 'Tor A', 'Initials': 'TA', 'LastName': 'Strand', 'Affiliation': 'Innlandet Hospital Trust, Lillehammer, Norway.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Kvestad', 'Affiliation': 'Regional Center for Child and Youth Mental Health and Child Welfare, NORCE Norwegian Research Center, Bergen, Norway.'}, {'ForeName': 'Maria W', 'Initials': 'MW', 'LastName': 'Markhus', 'Affiliation': 'Institute of Marine Research, Bergen, Norway.'}, {'ForeName': 'Per M', 'Initials': 'PM', 'LastName': 'Ueland', 'Affiliation': 'Bevital AS, Bergen, Norway.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'McCann', 'Affiliation': 'Bevital AS, Bergen, Norway.'}, {'ForeName': 'Jannike', 'Initials': 'J', 'LastName': 'Øyen', 'Affiliation': 'Institute of Marine Research, Bergen, Norway.'}]",The Journal of nutrition,['10.1093/jn/nxaa111']
101,31400517,Clinical exome sequencing vs. usual care for hereditary colorectal cancer diagnosis: A pilot comparative effectiveness study.,"BACKGROUND


Clinical exome sequencing (CES) provides the advantage of assessing genetic variation across the human exome compared to a traditional stepwise diagnostic approach or multi-gene panels. Comparative effectiveness research methods offer an approach to better understand the patient-centered and economic outcomes of CES.
PURPOSE


To evaluate CES compared to usual care (UC) in the diagnostic work-up of inherited colorectal cancer/polyposis (CRCP) in a randomized controlled trial (RCT).
METHODS


The primary outcome was clinical sensitivity for the diagnosis of inherited CRCP; secondary outcomes included psychosocial outcomes, family communication, and healthcare resource utilization. Participants were surveyed 2 and 4 weeks after results return and at 3-month intervals up to 1 year.
RESULTS


Evolving outcome measures and standard of care presented critical challenges. The majority of participants in the UC arm received multi-gene panels [94.73%]. Rates of genetic findings supporting the diagnosis of hereditary CRCP were 7.5% [7/93] vs. 5.4% [5/93] in the CES and UC arms, respectively (P = 0.28). Differences in privacy concerns after receiving CRCP results were identified (0.88 in UC vs 0.38 in CES, P = 0.05); however, healthcare resource utilization, family communication and psychosocial outcomes were similar between the two arms. More participants with positive results (17.7%) intended to change their life insurance 1  month after the first return visit compared to participants returned a variant of uncertain significance (9.1%) or negative result (4.8%) (P = 0.09).
CONCLUSION


Our results suggest that CES provides similar clinical benefits to multi-gene panels in the diagnosis of hereditary CRCP.",2019,"Differences in privacy concerns after receiving CRCP results were identified (0.88 in UC vs 0.38 in CES, P = 0.05); however, healthcare resource utilization, family communication and psychosocial outcomes were similar between the two arms.",['hereditary colorectal cancer diagnosis'],"['CES', 'usual care (UC']","['healthcare resource utilization, family communication and psychosocial outcomes', 'privacy concerns', 'clinical sensitivity for the diagnosis of inherited CRCP; secondary outcomes included psychosocial outcomes, family communication, and healthcare resource utilization']","[{'cui': 'C0439660', 'cui_str': 'Hereditary (qualifier value)'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}]",[],"[{'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0080048', 'cui_str': 'Privacy'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]",,0.0971893,"Differences in privacy concerns after receiving CRCP results were identified (0.88 in UC vs 0.38 in CES, P = 0.05); however, healthcare resource utilization, family communication and psychosocial outcomes were similar between the two arms.","[{'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Niu', 'Affiliation': 'Department of Epidemiology, University of Washington, Seattle, WA 98195, USA.'}, {'ForeName': 'Laura M', 'Initials': 'LM', 'LastName': 'Amendola', 'Affiliation': 'Department of Medicine, Division of Medical Genetics, University of Washington, Seattle, WA 98195, USA.'}, {'ForeName': 'Ragan', 'Initials': 'R', 'LastName': 'Hart', 'Affiliation': 'Department of Medicine, Division of Medical Genetics, University of Washington, Seattle, WA 98195, USA.'}, {'ForeName': 'Caroline S', 'Initials': 'CS', 'LastName': 'Bennette', 'Affiliation': 'Flatiron Health, New York, NY 10010, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Heagerty', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle, WA 98195, USA.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Horike-Pyne', 'Affiliation': 'Department of Medicine, Division of Medical Genetics, University of Washington, Seattle, WA 98195, USA.'}, {'ForeName': 'Susan B', 'Initials': 'SB', 'LastName': 'Trinidad', 'Affiliation': 'Department of Bioethics and Humanities, University of Washington, Seattle, WA 98195, USA.'}, {'ForeName': 'Elisabeth A', 'Initials': 'EA', 'LastName': 'Rosenthal', 'Affiliation': 'Department of Medicine, Division of Medical Genetics, University of Washington, Seattle, WA 98195, USA.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Comstock', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle, WA 98195, USA.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Nefcy', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle, WA 98195, USA.'}, {'ForeName': 'Fuki M', 'Initials': 'FM', 'LastName': 'Hisama', 'Affiliation': 'Department of Medicine, Division of Medical Genetics, University of Washington, Seattle, WA 98195, USA.'}, {'ForeName': 'Robin L', 'Initials': 'RL', 'LastName': 'Bennett', 'Affiliation': 'Department of Medicine, Division of Medical Genetics, University of Washington, Seattle, WA 98195, USA.'}, {'ForeName': 'William M', 'Initials': 'WM', 'LastName': 'Grady', 'Affiliation': 'Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA 98101, USA.'}, {'ForeName': 'Carlos J', 'Initials': 'CJ', 'LastName': 'Gallego', 'Affiliation': 'Department of Medicine, Division of Medical Genetics, University of Washington, Seattle, WA 98195, USA; Department of Genetics and Genome Sciences, Case Western Reserve University, Cleveland, OH 44106, USA; Comparative Health Outcomes, Economics and Policy Institute (CHOICE), University of Washington, Seattle, WA 98195, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Tarczy-Hornoch', 'Affiliation': 'Department of Biomedical Informatics and Medical Education, University of Washington, Seattle, WA 98195, USA.'}, {'ForeName': 'Stephanie M', 'Initials': 'SM', 'LastName': 'Fullerton', 'Affiliation': 'Department of Bioethics and Humanities, University of Washington, Seattle, WA 98195, USA.'}, {'ForeName': 'Wylie', 'Initials': 'W', 'LastName': 'Burke', 'Affiliation': 'Department of Bioethics and Humanities, University of Washington, Seattle, WA 98195, USA.'}, {'ForeName': 'Dean A', 'Initials': 'DA', 'LastName': 'Regier', 'Affiliation': 'Canadian Centre for Applied Research in Cancer Control, BC Cancer Agency, Vancouver, BC V5Z 1L3, Canada.'}, {'ForeName': 'Michael O', 'Initials': 'MO', 'LastName': 'Dorschner', 'Affiliation': 'Department of Pathology, University of Washington, Seattle, WA 98195, USA; Department of Genome Sciences, University of Washington, Seattle, WA 98195, USA.'}, {'ForeName': 'Brian H', 'Initials': 'BH', 'LastName': 'Shirts', 'Affiliation': 'Department of Laboratory Medicine, University of Washington, Seattle, WA 98195, USA.'}, {'ForeName': 'Peggy D', 'Initials': 'PD', 'LastName': 'Robertson', 'Affiliation': 'Department of Genome Sciences, University of Washington, Seattle, WA 98195, USA.'}, {'ForeName': 'Deborah A', 'Initials': 'DA', 'LastName': 'Nickerson', 'Affiliation': 'Department of Genome Sciences, University of Washington, Seattle, WA 98195, USA.'}, {'ForeName': 'Donald L', 'Initials': 'DL', 'LastName': 'Patrick', 'Affiliation': 'Department of Health Services, University of Washington, Seattle, WA 98195, USA.'}, {'ForeName': 'Gail P', 'Initials': 'GP', 'LastName': 'Jarvik', 'Affiliation': 'Department of Medicine, Division of Medical Genetics, University of Washington, Seattle, WA 98195, USA; Department of Genome Sciences, University of Washington, Seattle, WA 98195, USA.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Veenstra', 'Affiliation': 'Comparative Health Outcomes, Economics and Policy Institute (CHOICE), University of Washington, Seattle, WA 98195, USA. Electronic address: veenstra@uw.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105820']
102,31403536,Comparison of 2-Octylcyanoacrylate Versus 5-0 Fast-Absorbing Gut During Linear Wound Closures and the Effect on Wound Cosmesis.,"BACKGROUND


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


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


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


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


With the exception of inferior scar pigmentation with OCA, there was no statistically significant difference in wound cosmesis after linear wound closure with OCA versus FG.",2020,There was no significant difference in the total patient POSAS scores between closure with OCA (14.9 [8.67]) and FG (14.6 [8.90]),['44 patients with postoperative defects of at least 3 cm were included'],"['OCA versus FG', '2-octylcyanoacrylate (OCA', 'OCA', 'Comparisonof 2-Octylcyanoacrylate Versus 5-0 Fast-Absorbing Gut', 'OCA or FG']","['total patient POSAS scores', 'Observer Scar Assessment Scale (POSAS', 'observer POSAS scores, scar pigmentation', 'scar cosmesis', 'total observer POSAS score', 'wound cosmesis', 'Wound Cosmesis']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0391770', 'cui_str': '2-propenoic acid, 2-cyano-, octyl ester'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0008767', 'cui_str': 'Cicatrization'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales (assessment scale)'}, {'cui': 'C0031911', 'cui_str': 'Pigmentation'}, {'cui': 'C0021501', 'cui_str': 'wounds'}]",44.0,0.0371168,There was no significant difference in the total patient POSAS scores between closure with OCA (14.9 [8.67]) and FG (14.6 [8.90]),"[{'ForeName': 'Anne R', 'Initials': 'AR', 'LastName': 'Zhuang', 'Affiliation': 'Department of Dermatology, University of California, Davis, School of Medicine, Sacramento, California.'}, {'ForeName': 'Kourosh', 'Initials': 'K', 'LastName': 'Beroukhim', 'Affiliation': 'Department of Dermatology, University of California, Davis, School of Medicine, Sacramento, California.'}, {'ForeName': 'April W', 'Initials': 'AW', 'LastName': 'Armstrong', 'Affiliation': 'Department of Dermatology, Keck School of Medicine at University of Southern California, Los Angeles, California.'}, {'ForeName': 'Raja K', 'Initials': 'RK', 'LastName': 'Sivamani', 'Affiliation': 'Department of Dermatology, University of California, Davis, School of Medicine, Sacramento, California.'}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Eisen', 'Affiliation': 'Department of Dermatology, University of California, Davis, School of Medicine, Sacramento, California.'}]",Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.],['10.1097/DSS.0000000000002076']
103,31625954,"Efficacy, Patient-Reported Outcomes, and Safety for Millennial Subjects Treated With OnabotulinumtoxinA for Moderate to Severe Horizontal Forehead Lines.","BACKGROUND


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


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


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


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


OnabotulinumtoxinA treatment was well tolerated, and both age groups experienced significant improvements in FHL severity, high satisfaction, and improved psychological impacts after treatment. Millennials reported numerically greater improvements.",2020,Responder rates were significantly greater with onabotulinumtoxinA than placebo (p ≤ .015) for both groups through Day 180.,"['Millennials (aged 18-34 years) represent a growing segment of the facial aesthetic market', 'subjects aged at least 35 years after onabotulinumtoxinA treatment of forehead lines (FHL) across 2 phase 3 studies', ""Eligible subjects with moderate to severe FHL received onabotulinumtoxinA (FHL: 20 U; glabellar lines: 20 U, with/without 24 U in crow's feet line regions) or""]","['placebo', 'onabotulinumtoxinA', 'OnabotulinumtoxinA']","['Responder rates', 'FHL severity', 'FHL severity, high satisfaction, and improved psychological impacts']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0441635', 'cui_str': 'Segment (qualifier value)'}, {'cui': 'C0014901', 'cui_str': 'Esthetics'}, {'cui': 'C1318228', 'cui_str': 'Market (environment)'}, {'cui': 'C2719767', 'cui_str': 'onabotulinumtoxinA'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0016540', 'cui_str': 'Forehead'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0439561', 'cui_str': 'Phase 3 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0442019', 'cui_str': 'Glabellar (qualifier value)'}, {'cui': 'C0277939', 'cui_str': ""Crow's feet (finding)""}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2719767', 'cui_str': 'onabotulinumtoxinA'}]","[{'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}]",,0.0307912,Responder rates were significantly greater with onabotulinumtoxinA than placebo (p ≤ .015) for both groups through Day 180.,"[{'ForeName': 'Melanie D', 'Initials': 'MD', 'LastName': 'Palm', 'Affiliation': 'Art of Skin MD, Solana Beach, California.'}, {'ForeName': 'Julius', 'Initials': 'J', 'LastName': 'Few', 'Affiliation': 'The Few Institute for Aesthetic Plastic Surgery, Chicago, Illinois.'}, {'ForeName': 'Tapan', 'Initials': 'T', 'LastName': 'Patel', 'Affiliation': 'PHI Clinic, London, United Kingdom.'}, {'ForeName': 'Marva', 'Initials': 'M', 'LastName': 'Safa', 'Affiliation': 'La Jouvence, Neuchâtel, Switzerland.'}, {'ForeName': 'Adrienne', 'Initials': 'A', 'LastName': 'Drinkwater', 'Affiliation': 'Peloton Advantage, Parsippany, New Jersey.'}, {'ForeName': 'Cheri', 'Initials': 'C', 'LastName': 'Mao', 'Affiliation': 'Allergan plc, Irvine, California.'}, {'ForeName': 'Julie K', 'Initials': 'JK', 'LastName': 'Garcia', 'Affiliation': 'Allergan plc, Irvine, California.'}]",Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.],['10.1097/DSS.0000000000002216']
104,31634258,"Using a Multimedia Tool for Informed Consent in Mohs Surgery: A Randomized Trial Measuring Effects on Patient Anxiety, Knowledge, and Satisfaction.","BACKGROUND


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


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


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


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


A preoperative MMS educational video increased recognition of procedural risks, but did not improve patient anxiety or satisfaction.",2020,"From 231 consecutively enrolled subjects, there were no significant differences in anxiety (p = .626) or satisfaction (p = .065) between groups.","['Mohs Surgery', 'patients undergoing same-day office consultation and MMS', 'patients above the age of 18 years undergoing MMS for skin cancer between October 2015 and December 2015']","['short preoperative video on MMS in addition to traditional informed consent versus informed consent without video viewing', 'preoperative educational video']","['recognize risks of MMS', 'Patient Anxiety, Knowledge, and Satisfaction', 'Composite comprehension scores', 'patient anxiety or satisfaction', 'anxiety', 'preoperative anxiety, knowledge, and satisfaction', 'overall satisfaction']","[{'cui': 'C0079850', 'cui_str': 'Micrographic Surgery, Mohs'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0442603', 'cui_str': 'Office (environment)'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0007114', 'cui_str': 'Cancer of Skin'}]","[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0700287', 'cui_str': 'Informing (procedure)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.0549411,"From 231 consecutively enrolled subjects, there were no significant differences in anxiety (p = .626) or satisfaction (p = .065) between groups.","[{'ForeName': 'Macey', 'Initials': 'M', 'LastName': 'Delcambre', 'Affiliation': 'Department of Dermatology, Oregon Health and Science University, Portland, Oregon.'}, {'ForeName': 'Dylan', 'Initials': 'D', 'LastName': 'Haynes', 'Affiliation': 'Department of Dermatology, Oregon Health and Science University, Portland, Oregon.'}, {'ForeName': 'Tamar', 'Initials': 'T', 'LastName': 'Hajar', 'Affiliation': 'Department of Dermatology, Oregon Health and Science University, Portland, Oregon.'}, {'ForeName': 'Spring', 'Initials': 'S', 'LastName': 'Golden', 'Affiliation': 'Department of Dermatology, Oregon Health and Science University, Portland, Oregon.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Bar', 'Affiliation': 'Department of Dermatology, Oregon Health and Science University, Portland, Oregon.'}, {'ForeName': 'Emile', 'Initials': 'E', 'LastName': 'Latour', 'Affiliation': 'Knight Cancer Institute Biostatistics Shared Resource, Oregon Health and Science University, Portland, Oregon.'}, {'ForeName': 'Justin J', 'Initials': 'JJ', 'LastName': 'Leitenberger', 'Affiliation': 'Department of Dermatology, Oregon Health and Science University, Portland, Oregon.'}]",Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.],['10.1097/DSS.0000000000002213']
105,31652220,"Blinded, Randomized, Controlled Trial Evaluating the Effects of Light-Emitting Diode Photomodulation on Lower Extremity Wounds Left to Heal by Secondary Intention.","BACKGROUND


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


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


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


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


This study revealed that red LED photomodulation at a wavelength of 633 nm did not result in clinical improvement in wound healing of surgical defects on the lower extremities.",2020,The percentage of the original wound remaining was not statistically different between treatment and control groups between Weeks 1 and 2 (p = .71) and Weeks 3 and 4 (p = .56).,"['Fourteen subjects with surgical defects of the lower leg were irradiated with a 633 ±', 'Lower Extremity Wounds Left to Heal by Secondary Intention']","['red LED (wavelength 633 nm) photomodulation', '3-nm light source', 'Light-Emitting Diode Photomodulation', 'Light-emitting diode (LED']","['number of days required for wounds to heal', 'percentage of the original wound remaining']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C1140621', 'cui_str': 'Leg'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0205249', 'cui_str': 'Healed (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0162425', 'cui_str': 'Intention'}]","[{'cui': 'C0332575', 'cui_str': 'Red color (finding)'}, {'cui': 'C0449819', 'cui_str': 'Wavelength (qualifier value)'}, {'cui': 'C0181633', 'cui_str': 'Light source'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0023175', 'cui_str': 'Lead'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0205249', 'cui_str': 'Healed (qualifier value)'}, {'cui': 'C0205313', 'cui_str': 'Original (qualifier value)'}]",14.0,0.125328,The percentage of the original wound remaining was not statistically different between treatment and control groups between Weeks 1 and 2 (p = .71) and Weeks 3 and 4 (p = .56).,"[{'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Perper', 'Affiliation': '*All authors are affiliated with the Department of Dermatology and Cutaneous Surgery, University of Miami Hospital, Miami, Florida.'}, {'ForeName': 'Ariel', 'Initials': 'A', 'LastName': 'Eber', 'Affiliation': ''}, {'ForeName': 'Scott F', 'Initials': 'SF', 'LastName': 'Lindsey', 'Affiliation': ''}, {'ForeName': 'Keyvan', 'Initials': 'K', 'LastName': 'Nouri', 'Affiliation': 'All authors are affiliated with the Department of Dermatology and Cutaneous Surgery, University of Miami Hospital, Miami, Florida.'}]",Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.],['10.1097/DSS.0000000000002195']
106,31490311,Effect of Topical Garlic on Wound Healing and Scarring: A Clinical Trial.,"BACKGROUND


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


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


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


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


Surgical wounds treated with 30% garlic ointment healed with more cosmetically appealing scars than the Vaseline-treated sites.",2020,"Digital photograph analysis revealed less erythema at the garlic sites (p-value = .02).
",['Seventeen patients with 2 skin excisions applied a 30% garlic ointment to one surgical wound and Vaseline to the other surgical wound twice daily'],"['Topical Garlic', 'topical garlic']","['Wound Healing and Scarring', 'garlic site healed better', 'wound visual analog scales', 'cosmetically appealing scars']","[{'cui': 'C0450331', 'cui_str': '17 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0885057', 'cui_str': 'Garlic preparation'}, {'cui': 'C0028912', 'cui_str': 'Salves'}, {'cui': 'C0332803', 'cui_str': 'Surgical Incision'}, {'cui': 'C0728774', 'cui_str': 'Vaseline'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}]","[{'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0885057', 'cui_str': 'Garlic preparation'}]","[{'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0008767', 'cui_str': 'Cicatrization'}, {'cui': 'C0885057', 'cui_str': 'Garlic preparation'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0205249', 'cui_str': 'Healed (qualifier value)'}, {'cui': 'C0332272', 'cui_str': 'Better (qualifier value)'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",,0.0370612,"Digital photograph analysis revealed less erythema at the garlic sites (p-value = .02).
","[{'ForeName': 'Minhal', 'Initials': 'M', 'LastName': 'Alhashim', 'Affiliation': 'Department of Dermatology, Alhabib Medical Group, Khobar, Saudi Arabia.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Lombardo', 'Affiliation': 'University of North Dakota, School of Medicine and Health Sciences, Grand Forks, North Dakota.'}]",Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.],['10.1097/DSS.0000000000002123']
107,32321477,Collaborative Assessment and Management of Suicidality (CAMS) compared to enhanced treatment as usual (E-TAU) for suicidal patients in an inpatient setting: study protocol for a randomized controlled trial.,"BACKGROUND


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


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


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


This clinical trial has been retrospectively registered with the German Clinical Trials Register; registration code/ DRKS-ID: DRKS00013727 (on January 12, 2018). In addition, the study was also registered with the International Clinical Trials Registry Platform of the World Health Organization (identical registration code). Registry Name: ""Evaluation von CAMS versus TAU bei suizidalen Patienten - Ein stationärer RCT"".",2020,In this randomized controlled trial (RCT) we are investigating whether CAMS is more effective than Enhanced-Treatment as Usual (E-TAU) in reducing suicidal thoughts as primary outcome variable.,"['suicidal patients', '60 participants with different diagnoses, who are admitted as inpatients because of acute suicidal thoughts or behaviors into the Clinic for Psychiatry and Psychotherapy, Ev']","['CAMS', 'Collaborative Assessment and Management of Suicidality (CAMS']","['suicidal ideation and overall symptom distress', 'severity of psychiatric symptoms, depression, reasons for living, and therapeutic relationship', 'Beck Scale for Suicide Ideation']","[{'cui': 'C0438696', 'cui_str': 'Suicidal'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0233401', 'cui_str': 'Psychiatric symptom'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0582614', 'cui_str': 'Beck scale for suicide ideation'}]",60.0,0.28712,In this randomized controlled trial (RCT) we are investigating whether CAMS is more effective than Enhanced-Treatment as Usual (E-TAU) in reducing suicidal thoughts as primary outcome variable.,"[{'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Santel', 'Affiliation': 'Clinic of Psychiatry and Psychotherapy, Ev. Hospital Bethel, Bielefeld, Germany. Miriam.Santel@uni-bielefeld.de.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Beblo', 'Affiliation': 'Clinic of Psychiatry and Psychotherapy, Ev. Hospital Bethel, Bielefeld, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Neuner', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Bielefeld University, Bielefeld, Germany.'}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Berg', 'Affiliation': 'Clinic of Psychiatry and Psychotherapy, Ev. Hospital Bethel, Bielefeld, Germany.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Hennig-Fast', 'Affiliation': 'Clinic of Psychiatry and Psychotherapy, Ev. Hospital Bethel, Bielefeld, Germany.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Jobes', 'Affiliation': 'Department of Psychology, The Catholic University of America, Washington, DC, USA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Driessen', 'Affiliation': 'Clinic of Psychiatry and Psychotherapy, Ev. Hospital Bethel, Bielefeld, Germany.'}]",BMC psychiatry,['10.1186/s12888-020-02589-x']
108,32338611,Effectiveness of additional X-ray protection devices in reducing scattered radiation in radial intervention: the ESPRESSO randomised trial.,"AIMS


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


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


The use of an additional drape reduced the radiation exposure of both the first operator and the second operator during routine radial procedures; a shield-attached curtain alone was only partially effective. ClinicalTrials.gov identifier: NCT03634657 Visual summary. X-ray protection devices and their effects on radiation exposure.",2020,The use of an additional drape reduced radiation exposure of both the first and second operator during routine radial procedures; a shield-attached curtain alone was only partially effective.,"['radial interventiOn', 'A total of 614 radial procedures were randomized (n=193 shield, n=220 shield+curtain, n=201 shield+curtain+drape']","['radiation protection devices', 'additional x-ray PRotection dEviceS', 'shield+curtain+drape', 'shield-only protection (shield group), shield and overlapping 0.5mm Pb panel curtain (shield+curtain group) or shield, curtain and additional 75x40cm, 0.5mm Pb drape placed across the waist of the patient (shield+curtain+drape group']","[""primary endpoint (relative exposure ratio between operator's exposure in μSv and patient exposure, dose area product in cGy·cm2""]","[{'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0183251', 'cui_str': 'Shield'}]","[{'cui': 'C0034533', 'cui_str': 'Protection, Radiation'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0183251', 'cui_str': 'Shield'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0185027', 'cui_str': 'Imbrication'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0556652', 'cui_str': 'mm Pb'}, {'cui': 'C0441833', 'cui_str': 'Groups'}, {'cui': 'C0180239', 'cui_str': 'Curtain'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0230097', 'cui_str': 'Structure of waist (surface region)'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]",614.0,0.112666,The use of an additional drape reduced radiation exposure of both the first and second operator during routine radial procedures; a shield-attached curtain alone was only partially effective.,"[{'ForeName': 'Remzi', 'Initials': 'R', 'LastName': 'Anadol', 'Affiliation': 'Zentrum für Kardiologie, Kardiologie I, Universitätsmedizin Mainz and DZHK Standort Rhein-Main, Mainz, Germany.'}, {'ForeName': 'Moritz', 'Initials': 'M', 'LastName': 'Brandt', 'Affiliation': ''}, {'ForeName': 'Nico', 'Initials': 'N', 'LastName': 'Merz', 'Affiliation': ''}, {'ForeName': 'Maike', 'Initials': 'M', 'LastName': 'Knorr', 'Affiliation': ''}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Ahoopai', 'Affiliation': ''}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Geyer', 'Affiliation': ''}, {'ForeName': 'Damian', 'Initials': 'D', 'LastName': 'Krompiec', 'Affiliation': ''}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Wenzel', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Münzel', 'Affiliation': ''}, {'ForeName': 'Tommaso', 'Initials': 'T', 'LastName': 'Gori', 'Affiliation': ''}]",EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology,['10.4244/EIJ-D-19-00945']
109,31419605,"Rationale, design, and baseline data for a multicenter randomized clinical trial comparing depression screening strategies after acute coronary syndrome: The comparison of depression identification after acute Coronary Syndromes-Quality of Life and Cost Outcomes (CODIACS-QOL) trial.","BACKGROUND


Elevated depressive symptoms among survivors of acute coronary syndromes (ACS) confer recurrent cardiovascular events and mortality, worse quality of life, and higher healthcare costs. While multiple scientific groups advise routine depression screening for ACS survivors, no randomized trials exist to inform this screening recommendation. We aimed to assess the effect of screening for depression on change in quality of life over 18 months among ACS patients.
METHODS


The Comparison of Depression Identification after Acute Coronary Syndrome on Quality of Life and Cost Outcomes (CODIACS-QoL) trial is a pragmatic, 3-arm trial that randomized ACS patients to 1) systematic depression screening using the 8-item Patient Health Questionnaire (PHQ-8) and if positive screen (PHQ-8 ≥ 10), notification of primary care providers (PCPs) and invitation to participate in centralized, patient-preference, stepped depression care (Screen, Notify, and Treat, N = 499); 2) systematic depression screening and PCP notification only (Screen and Notify, N = 501); and 3) usual care (No Screen, N = 500). Adults hospitalized for ACS in the previous 2-12 months without prior history of depression were eligible for participation. Key outcomes will be quality-adjusted life years (primary), cost of health care utilization, and depression-free days across 18 months.
RESULTS


A total of 1500 patients were randomized in the CODIACS-QOL trial (28.3% women; 16.3% Hispanic; mean age 65.9 (11.5) years). Only 7% of ACS survivors had elevated depressive symptoms.
CONCLUSIONS


Using a novel randomization schema and pragmatic design principles, the CODIACS-QoL trial achieved its enrollment target. Eventual results of this trial will inform future depression screening recommendations in cardiac patients.
TRIAL REGISTRATION


ClinicalTrials.gov (NCT01993017).",2019,"Only 7% of ACS survivors had elevated depressive symptoms.
","['ACS patients', 'Adults hospitalized for ACS in the previous 2-12\u202fmonths without prior history of depression were eligible for participation', 'cardiac patients', 'after acute coronary syndrome', 'A total of 1500 patients were randomized in the CODIACS-QOL trial (28.3% women; 16.3% Hispanic; mean age 65.9 (11.5) years', 'survivors of acute coronary syndromes (ACS']","['depression screening strategies', 'positive screen (PHQ-8\u202f≥\u202f10), notification of primary care providers (PCPs) and invitation to participate in centralized, patient-preference, stepped depression care (Screen, Notify, and Treat, N\u202f=\u202f499); 2) systematic depression screening and PCP notification only (Screen and Notify, N\u202f=\u202f501); and 3) usual care (No Screen, N\u202f=\u202f500']","['quality-adjusted life years (primary), cost of health care utilization, and depression-free days across 18\u202fmonths', 'quality of life', 'elevated depressive symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0455503', 'cui_str': 'H/O: depression'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517534', 'cui_str': '11.5 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0740218', 'cui_str': 'Depression screening (procedure)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0422202', 'cui_str': 'Notifications (procedure)'}, {'cui': 'C2735026', 'cui_str': 'Primary care provider (occupation)'}, {'cui': 'C0376409', 'cui_str': 'Patient Preference'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0220922', 'cui_str': 'systematics'}, {'cui': 'C0031381', 'cui_str': '1-(1-Phenylcyclohexyl)piperidine'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}]","[{'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0030672', 'cui_str': 'Patient Acceptance of Healthcare'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}]",1500.0,0.252491,"Only 7% of ACS survivors had elevated depressive symptoms.
","[{'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Moise', 'Affiliation': 'Columbia University Medical Center, New York, NY, United States of America. Electronic address: nm2562@cumc.columbia.edu.'}, {'ForeName': 'Karina W', 'Initials': 'KW', 'LastName': 'Davidson', 'Affiliation': 'Northwell Health, New York, NY, United States of America.'}, {'ForeName': 'Ying Kuen K', 'Initials': 'YKK', 'LastName': 'Cheung', 'Affiliation': 'Columbia University Medical Center, New York, NY, United States of America.'}, {'ForeName': 'Gregory N', 'Initials': 'GN', 'LastName': 'Clarke', 'Affiliation': 'Kaiser Permanente Northwest, Portland, OR, United States of America.'}, {'ForeName': 'Rowena J', 'Initials': 'RJ', 'LastName': 'Dolor', 'Affiliation': 'Duke Primary Care Research Consortium, Durham, NC, United States of America.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Duer-Hefele', 'Affiliation': 'Northwell Health, New York, NY, United States of America.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Ladapo', 'Affiliation': 'University of California Los Angeles, Los Angeles, CA, United States of America.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Margolis', 'Affiliation': 'HealthPartners, Minneapolis, MN, United States of America.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'St Onge', 'Affiliation': 'Columbia University Medical Center, New York, NY, United States of America.'}, {'ForeName': 'Faith', 'Initials': 'F', 'LastName': 'Parsons', 'Affiliation': 'Columbia University Medical Center, New York, NY, United States of America.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Retuerto', 'Affiliation': 'Columbia University Medical Center, New York, NY, United States of America.'}, {'ForeName': 'Kristine M', 'Initials': 'KM', 'LastName': 'Schmit', 'Affiliation': 'Duke Primary Care Research Consortium, Durham, NC, United States of America.'}, {'ForeName': 'Anusorn', 'Initials': 'A', 'LastName': 'Thanataveerat', 'Affiliation': 'Columbia University Medical Center, New York, NY, United States of America.'}, {'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Kronish', 'Affiliation': 'Columbia University Medical Center, New York, NY, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105826']
110,31419607,Reducing sexual health risks and substance use in the prenatal setting: A study protocol for a randomized controlled trial.,"Sexually transmitted infections (STIs) are at a record high in the United States, and STI risk is a critical and costly public health concern for childbearing women. STIs can lead to a number of serious health risks including premature birth, low birth weight, ectopic pregnancy, and fetal death. Similarly, there has been a dramatic increase in substance use during pregnancy, leading to complications during pregnancy and poorer birth outcomes. Women who misuse substances are disproportionately more likely to engage in risky sexual behaviors that can result in STIs. The proposed study will test whether the Health Check-Up for Expectant Moms (HCEM), a computer-delivered brief intervention that simultaneously targets STI risk and alcohol/illicit drug use during pregnancy, reduces antenatal and postpartum risk more than an attention, time, and information matched control condition among pregnant women seeking prenatal care. The study is a two-group, randomized controlled trial in which a diverse sample of 250 pregnant women will be recruited from prenatal care clinics and assigned to either (a) a computer-delivered, single-session brief intervention plus two booster sessions); or (b) a computer-delivered control condition. Follow-up assessments will occur at 2 and 6 months from baseline, and at 6 weeks postpartum. Our objective measures include STI incidence and birth outcomes. The results of this trial will fill a critical gap and provide much-needed data on the efficacy, costs, and resource utilization of a practical computer-delivered, brief motivational intervention tailored to reach high-risk women during pregnancy and extending impact to postpartum.",2019,"The proposed study will test whether the Health Check-Up for Expectant Moms (HCEM), a computer-delivered brief intervention that simultaneously targets STI risk and alcohol/illicit drug use during pregnancy, reduces antenatal and postpartum risk more than an attention, time, and information matched control condition among pregnant women seeking prenatal care.","['childbearing women', 'pregnant women seeking prenatal care', '250 pregnant women will be recruited from prenatal care clinics and assigned to either (a) a']","['computer-delivered, single-session brief intervention plus two booster sessions); or (b) a computer-delivered control condition', 'Health Check-Up for Expectant Moms (HCEM']","['risky sexual behaviors', 'STI incidence and birth outcomes', 'sexual health risks']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0033052', 'cui_str': 'Antenatal Care'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1697762', 'cui_str': 'Booster'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1442163', 'cui_str': 'Multiple of the median'}]","[{'cui': 'C0036864', 'cui_str': 'Sexual Behavior'}, {'cui': 'C0036916', 'cui_str': 'STDs'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1286282', 'cui_str': 'Birth outcome'}, {'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",250.0,0.0740378,"The proposed study will test whether the Health Check-Up for Expectant Moms (HCEM), a computer-delivered brief intervention that simultaneously targets STI risk and alcohol/illicit drug use during pregnancy, reduces antenatal and postpartum risk more than an attention, time, and information matched control condition among pregnant women seeking prenatal care.","[{'ForeName': 'Golfo', 'Initials': 'G', 'LastName': 'Tzilos Wernette', 'Affiliation': 'Department of Family Medicine, University of Michigan, Ann Arbor, MI 48104, United States of America. Electronic address: gtzilos@med.umich.edu.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Plegue', 'Affiliation': 'Department of Family Medicine, University of Michigan, Ann Arbor, MI 48104, United States of America.'}, {'ForeName': 'Okeoma', 'Initials': 'O', 'LastName': 'Mmeje', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Michigan, Ann Arbor, MI 48104, United States of America.'}, {'ForeName': 'Ananda', 'Initials': 'A', 'LastName': 'Sen', 'Affiliation': 'Department of Family Medicine, University of Michigan, Ann Arbor, MI 48104, United States of America.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Countryman', 'Affiliation': 'Department of Family Medicine, University of Michigan, Ann Arbor, MI 48104, United States of America.'}, {'ForeName': 'Quyen', 'Initials': 'Q', 'LastName': 'Ngo', 'Affiliation': 'Department of Emergency Medicine, University of Michigan, Ann Arbor, MI 48109, United States of America.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Prosser', 'Affiliation': 'Department of Pediatrics and Communicable Diseases, University of Michigan, Ann Arbor, MI 48104, United States of America.'}, {'ForeName': 'Caron', 'Initials': 'C', 'LastName': 'Zlotnick', 'Affiliation': 'Department of Psychiatry and Human Behavior, Brown University, Providence, RI 02906, United States of America; Women and Infants Hospital, Providence, RI 02906, United States of America; Department of Psychiatry and Mental Health, University of Cape Town, South Africa.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105827']
111,31784365,The Effect of Delayed Injection of Leukocyte-Rich Platelet-Rich Plasma Following Rotator Cuff Repair on Patient Function: A Randomized Double-Blind Controlled Trial.,"PURPOSE


To investigate the effect of delayed application of leukocyte-rich platelet-rich plasma (PRP) on rotator cuff repair results as assessed by outcome scores and imaging at one year.
METHODS


Patients with a symptomatic rotator cuff tear awaiting arthroscopic repair were approached to take part in the study. Final eligibility for the study was confirmed at the time of surgery. A total of 97 patients were randomized to an ultrasound guided injection of leukocyte-rich PRP or normal saline between 10 and 14 days postsurgery. A total of 87 patients completed clinical evaluation and underwent magnetic resonance imaging imaging at 1 year. Outcome scores included the American Shoulder and Elbow Score, Constant score, Western Ontario Rotator Cuff Index, and the Disabilities of the Arm, Shoulder and Hand Score. Structural integrity of the repair was assessed according to the Sugaya grading. Muscle fatty infiltration was assessed on magnetic resonance imaging using the Goutallier classification.
RESULTS


At 1 year postsurgery, there was no significant difference between the treatment groups on any of the patient-reported outcome measures or Constant score. On postoperative imaging analysis, there was no difference in the retear rates (Sugaya 4 and 5) between the groups (21% in control group vs 15.3% in PRP group). Fatty infiltration on postoperative imaging was found to be significantly higher in the normal saline group compared with the PRP group (Kendall's tau-b P = .032).
CONCLUSIONS


The delayed application of PRP postrotator cuff repair did not improve function as measured by patient-reported outcome measures and Constant score at 1 year postoperatively.
LEVEL OF EVIDENCE


Level II, prospective randomized therapeutic trial.",2020,"At 1 year postsurgery, there was no significant difference between the treatment groups on any of the patient-reported outcome measures or Constant score.","['97 patients', '87 patients completed clinical evaluation and underwent', 'Rotator Cuff Repair on Patient Function', 'Patients with a symptomatic rotator cuff tear awaiting arthroscopic repair were approached to take part in the study']","['ultrasound guided injection of leukocyte-rich PRP or normal saline', 'leukocyte-rich platelet-rich plasma (PRP', 'magnetic resonance imaging imaging', 'Delayed Injection of Leukocyte-Rich Platelet-Rich Plasma (LR-PRP', 'PRP']","['Muscle fatty infiltration', 'retear rates', 'American Shoulder and Elbow Score, Constant score, Western Ontario Rotator Cuff Index, and the Disabilities of the Arm, Shoulder and Hand Score', 'Fatty infiltration on postoperative imaging']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0186666', 'cui_str': 'Repair of musculotendinous cuff of shoulder (procedure)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0263912', 'cui_str': 'Rotator Cuff Tears'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0023516', 'cui_str': 'Blood Corpuscles, White'}, {'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}, {'cui': 'C0242848', 'cui_str': 'PrP (GSS)'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma (substance)'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0333575', 'cui_str': 'Fatty infiltration (morphologic abnormality)'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0013769', 'cui_str': 'Elbow'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0085515', 'cui_str': 'Rotator Cuff'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]",97.0,0.320379,"At 1 year postsurgery, there was no significant difference between the treatment groups on any of the patient-reported outcome measures or Constant score.","[{'ForeName': 'Martyn', 'Initials': 'M', 'LastName': 'Snow', 'Affiliation': 'Royal Orthopaedic Hospital NHS Foundation Trust, Northfield, United Kingdom; Department of Chemical Engineering, University of Birmingham, Edgbaston, Birmingham, United Kingdom. Electronic address: martyn.snow@nhs.net.'}, {'ForeName': 'Faisal', 'Initials': 'F', 'LastName': 'Hussain', 'Affiliation': 'Royal Orthopaedic Hospital NHS Foundation Trust, Northfield, United Kingdom.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Pagkalos', 'Affiliation': 'Royal Orthopaedic Hospital NHS Foundation Trust, Northfield, United Kingdom.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Kowalski', 'Affiliation': 'Royal Orthopaedic Hospital NHS Foundation Trust, Northfield, United Kingdom.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Green', 'Affiliation': 'Royal Orthopaedic Hospital NHS Foundation Trust, Northfield, United Kingdom.'}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Massoud', 'Affiliation': 'Royal Orthopaedic Hospital NHS Foundation Trust, Northfield, United Kingdom.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'James', 'Affiliation': 'Royal Orthopaedic Hospital NHS Foundation Trust, Northfield, United Kingdom.'}]",Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association,['10.1016/j.arthro.2019.09.026']
112,31477748,Effects of Preservative-free 3% Diquafosol in Patients with Pre-existing Dry Eye Disease after Cataract Surgery: A Randomized Clinical Trial.,"Dry eye disease (DED) after cataract surgery has become a critical concern, and various therapeutic options have been developed. Recently, preservative-free diquafosol ophthalmic solution has been introduced; however, its therapeutic effect on DED after cataract surgery has not been reported. We investigated the efficacy of preservative-free diquafosol in patients with pre-existing DED after cataract surgery. We divided subjects who were diagnosed with DED and scheduled to undergo cataract surgery, into 3 groups (preservative-free diquafosol, group 1; preservative-containing diquafosol, group 2; preservative-free hyaluronate, group 3), and each eye drops was administered 6 times daily after surgery. Tear break up time (TBUT), Ocular Surface Disease Index (OSDI), corneal staining score, lid margin abnormality, and meibum quality improved over time in group 1. Groups 1 and 2 had significantly superior TBUT, meibomian gland dysfunction grade, and meibomian gland expressibility throughout the study period than group 3. Meibum quality of group 1 was significantly better than group 2 at 1 and 3 months after surgery. Preservative-free diquafosol showed better efficacy in treating DED after cataract surgery than preservative-containing diquafosol or preservative-free hyaluronate. Preservative-free diquafosol may serve as a reliable option for the management of patients with pre-existing DED after phacoemulsification.",2019,Preservative-free diquafosol showed better efficacy in treating DED after cataract surgery than preservative-containing diquafosol or preservative-free hyaluronate.,"['patients with pre-existing DED after phacoemulsification', 'divided subjects who were diagnosed with DED and scheduled to undergo', 'Dry eye disease (DED) after cataract surgery', 'Patients with Pre-existing Dry Eye Disease after Cataract Surgery', 'patients with pre-existing DED after cataract surgery']","['Preservative-free diquafosol', 'preservative-free diquafosol', 'cataract surgery, into 3 groups (preservative-free diquafosol, group 1; preservative-containing diquafosol, group 2; preservative-free hyaluronate', 'Preservative-free 3% Diquafosol']","['Tear break up time (TBUT), Ocular Surface Disease Index (OSDI), corneal staining score, lid margin abnormality, and meibum quality', 'superior TBUT, meibomian gland dysfunction grade, and meibomian gland expressibility', 'Meibum quality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C2193446', 'cui_str': 'Phacoemulsification'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0314719', 'cui_str': 'Dry eyes (finding)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1306068', 'cui_str': 'Secondary Cataract'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C1955479', 'cui_str': ""diuridine 5'-(pentahydrogen tetraphosphate) tetrasodium salt""}, {'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0178695', 'cui_str': 'hyaluronate'}]","[{'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1557335', 'cui_str': 'Ocular surface disease'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0423232', 'cui_str': 'Corneal epithelial staining pattern (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444582', 'cui_str': 'Structure of free margin of eyelid'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C1275684', 'cui_str': 'MGD-Meibomian gland dysfunction'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0025181', 'cui_str': 'Tarsal Glands'}]",,0.024437,Preservative-free diquafosol showed better efficacy in treating DED after cataract surgery than preservative-containing diquafosol or preservative-free hyaluronate.,"[{'ForeName': 'Ikhyun', 'Initials': 'I', 'LastName': 'Jun', 'Affiliation': 'The Institute of Vision Research, Department of Ophthalmology, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemungu, Seoul, 03722, Korea.'}, {'ForeName': 'Seonghee', 'Initials': 'S', 'LastName': 'Choi', 'Affiliation': 'The Institute of Vision Research, Department of Ophthalmology, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemungu, Seoul, 03722, Korea.'}, {'ForeName': 'Geun Young', 'Initials': 'GY', 'LastName': 'Lee', 'Affiliation': 'The Institute of Vision Research, Department of Ophthalmology, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemungu, Seoul, 03722, Korea.'}, {'ForeName': 'Young Joon', 'Initials': 'YJ', 'LastName': 'Choi', 'Affiliation': 'The Institute of Vision Research, Department of Ophthalmology, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemungu, Seoul, 03722, Korea.'}, {'ForeName': 'Hyung Keun', 'Initials': 'HK', 'LastName': 'Lee', 'Affiliation': 'The Institute of Vision Research, Department of Ophthalmology, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemungu, Seoul, 03722, Korea.'}, {'ForeName': 'Eung Kweon', 'Initials': 'EK', 'LastName': 'Kim', 'Affiliation': 'The Institute of Vision Research, Department of Ophthalmology, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemungu, Seoul, 03722, Korea.'}, {'ForeName': 'Kyoung Yul', 'Initials': 'KY', 'LastName': 'Seo', 'Affiliation': 'The Institute of Vision Research, Department of Ophthalmology, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemungu, Seoul, 03722, Korea.'}, {'ForeName': 'Tae-Im', 'Initials': 'TI', 'LastName': 'Kim', 'Affiliation': 'The Institute of Vision Research, Department of Ophthalmology, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemungu, Seoul, 03722, Korea. tikim@yuhs.ac.'}]",Scientific reports,['10.1038/s41598-019-49159-0']
113,32331460,"The Effects of Biofeedback Training and Smartphone-Delivered Biofeedback Training on Resilience, Occupational Stress, and Depressive Symptoms among Abused Psychiatric Nurses.","Psychiatric ward (PW) nurses are at a higher risk to encounter workplace violence than are other healthcare providers, and many interventions have been developed to improve their mental health. We compared the effectiveness of biofeedback training (BT) and smartphone-delivered BT (SDBT) interventions on occupational stress, depressive symptoms, resilience, heart rate variability, and respiration rate in a sample of abused PW nurses. This was a quasi-experimental study. Structured questionnaires were administered before and six weeks after the intervention. Data were collected from April 2017 to October 2017. A total of 159 abused PW nurses were randomly assigned to BT, SDBT, and control groups, and 135 of them completed all processes of our protocol, with the study consisting of 119 females (88.1%) and 16 males (11.9%) and their age range being from 22 to 59 with the mean age of 35.61 and a standard deviation of 8.16. Compared to the controls, both the BT and the SDBT intervention groups experienced significant improvements in depressive symptoms, resilience, and respiration rate; and the SDBT group experienced significant reductions in occupational stress. Considering the cost, accessibility, restrictions time and space, SDBT be used as an effective intervention in people with resilience or occupational stress.",2020,"Compared to the controls, both the BT and the SDBT intervention groups experienced significant improvements in depressive symptoms, resilience, and respiration rate; and the SDBT group experienced significant reductions in occupational stress.","['people with resilience or occupational stress', 'Abused Psychiatric Nurses', ' and control groups, and 135 of them completed all processes of our protocol, with the study consisting of 119 females (88.1%) and 16 males (11.9%) and their age range being from 22 to 59 with the mean age of 35.61 and a standard deviation of 8.16', '159 abused PW nurses']","['biofeedback training (BT) and smartphone-delivered BT (SDBT) interventions', 'SDBT intervention', 'Biofeedback Training and Smartphone-Delivered Biofeedback Training', 'BT, SDBT']","['occupational stress, depressive symptoms, resilience, heart rate variability, and respiration rate', 'Resilience, Occupational Stress, and Depressive Symptoms', 'depressive symptoms, resilience, and respiration rate', 'occupational stress']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0814090', 'cui_str': 'Job-related Stress'}, {'cui': 'C0562381', 'cui_str': 'Victim of abuse'}, {'cui': 'C0033870', 'cui_str': 'Nursing, Psychiatric'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0023449', 'cui_str': 'Acute lymphoid leukemia'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}]","[{'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0814090', 'cui_str': 'Job-related Stress'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}]",,0.0281066,"Compared to the controls, both the BT and the SDBT intervention groups experienced significant improvements in depressive symptoms, resilience, and respiration rate; and the SDBT group experienced significant reductions in occupational stress.","[{'ForeName': 'Hsiu-Fen', 'Initials': 'HF', 'LastName': 'Hsieh', 'Affiliation': 'School of Nursing, College of Nursing, Kaohsiung Medical University, No. 100, Shih-Chuan 1st Road, Kaohsiung 807, Taiwan.'}, {'ForeName': 'I-Chin', 'Initials': 'IC', 'LastName': 'Huang', 'Affiliation': 'School of Nursing, College of Nursing, Kaohsiung Medical University, No. 100, Shih-Chuan 1st Road, Kaohsiung 807, Taiwan.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'School of Nursing, College of Nursing, Kaohsiung Medical University, No. 100, Shih-Chuan 1st Road, Kaohsiung 807, Taiwan.'}, {'ForeName': 'Wen-Ling', 'Initials': 'WL', 'LastName': 'Chen', 'Affiliation': 'Department of Nursing, Tsyr-Huey Mental Hospital, Kaohsiung 831, Taiwan.'}, {'ForeName': 'Yi-Wen', 'Initials': 'YW', 'LastName': 'Lee', 'Affiliation': 'Nursing Department, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung 833, Taiwan.'}, {'ForeName': 'Hsin-Tien', 'Initials': 'HT', 'LastName': 'Hsu', 'Affiliation': 'School of Nursing, College of Nursing, Kaohsiung Medical University, No. 100, Shih-Chuan 1st Road, Kaohsiung 807, Taiwan.'}]",International journal of environmental research and public health,['10.3390/ijerph17082905']
114,32165605,Influence of energy drinks on acute hemodynamic parameters in young healthy adults: a randomized double-blind placebo-controlled crossover pilot study.,,2020,,['young healthy adults'],"['placebo', 'energy drinks']",['acute hemodynamic parameters'],"[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3179078', 'cui_str': 'Energy Drinks'}]","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.397032,,"[{'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Stopa', 'Affiliation': '1st Department of Cardiology, Interventional Electrocardiology, and Hypertension, Institute of Cardiology, Jagiellonian University Medical College, Kraków, Poland'}, {'ForeName': 'Mateusz', 'Initials': 'M', 'LastName': 'Łobacz', 'Affiliation': 'Department of Oncology, University Hospital, Kraków, Poland'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Niemczyk', 'Affiliation': 'Department of Cardiology, Rydygier Hospital, Kraków, Poland'}, {'ForeName': 'Karolina', 'Initials': 'K', 'LastName': 'Rudowska', 'Affiliation': '5th Military Hospital with Polyclinic, Kraków, Poland'}, {'ForeName': 'Agata', 'Initials': 'A', 'LastName': 'Radko', 'Affiliation': 'Department of Pulmonology, 5th Military Hospital with Polyclinic in Kraków, Poland'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Mikunda', 'Affiliation': 'St. John Grande Hospital, Kraków, Poland'}, {'ForeName': 'Danuta', 'Initials': 'D', 'LastName': 'Czarnecka', 'Affiliation': '1st Department of Cardiology, Interventional Electrocardiology, and Hypertension, Institute of Cardiology, Jagiellonian University Medical College, Kraków, Poland'}, {'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Olszanecka', 'Affiliation': '1st Department of Cardiology, Interventional Electrocardiology, and Hypertension, Institute of Cardiology, Jagiellonian University Medical College, Kraków, Poland. agnieszka.olszanecka@uj.edu.pl'}]",Kardiologia polska,['10.33963/KP.15231']
115,32166681,"Application of Low Tube Voltage, Low-concentration Contrast Agent Using a 320-row CT in Coronary CT Angiography: Evaluation of Image Quality, Radiation Dose and Iodine Intake.","The effect of low voltage and low concentration contrast agent on image quality of coronary CT angiography, radiation dose and iodine intake was evaluated. A total of 121 patients with body mass index (BMI) <26 kg/m 2  and heart rate (HR) <70 beats/min were randomly divided into four groups: group A (n=31, 80 kVp, 270 mgI/mL); group B (n=33, 100 kVp, 270 mgI/mL); group C (n=30, 100 kVp, 320 mgI/mL); group D (n=27, 100 kVp, 400 mgI/mL). The automatic current modulation system and the iterative algorithm for reconstruction were adopted in each group. The CT values and SD values of the aortic root (AR), subcutaneous fat, left coronary artery opening (LCA), and right coronary artery opening (RCA) were measured in all groups, the signal-to-noise ratio (SNR) and contrast noise ratio (CNR) were calculated, and effective radiation dose and iodine intake were recorded. The subjective assessment for image quality was performed by two physicians using a 4-point scale. The results were compared using the one-way ANOVA and rank sum tests. The image quality of the four groups met the clinical diagnostic requirements. The CT values of AR in groups A, B, C, and D were 537.6±71.4, 447.2±81.9, 445.2±64.9 and 518.5±94.9 Hu, respectively, with no significant difference between group A and group D, or between group B and group C, while CT values in groups B and C were significantly lower than those in groups A and D (P<0.05). In groups A, B, C, and D, the LCA SNR values were 22.7±9.1, 23.3±9.1, 23.3±7.7 and 26.6±8.9, and the RCA CNR values were 26.9±9.8, 28.5±11.4, 27.7±8.8 and 32.1±10.6, respectively. The AR visual scores in groups A, B, C and D were 3.8±0.2, 3.9±0.3, 3.9±0.3 and 4.0±0.3, respectively. There were no significant differences in SNR, CNR and visual score among the four groups (P>0.05). The radiation doses in groups A, B, C and D were 2.6±1.4, 3.6±1.8, 4.9±3.5 and 4.9±2.8 mSv, respectively. The radiation dose in group A was significantly less than that in the rest three groups (P<0.05). The iodine intakes in groups A, B, C and D were 14.9±1.5, 15.0±1.5, 17.7±2.0 and 18.1±2.5 g, respectively. There was no significant difference in the intake of iodine between groups C and D, or between groups A and B, while iodine intake in groups A and B were significantly reduced as compared with that in groups C and D (P<0.05). It was concluded that for patients with low BMI and controlled HR, compared to 100 kVp tube voltage combined with multiple concentration contrast agents, 80 kVp combined with 270 mgI/mL contrast agent is enough to ensure the quality of the images, and can reduce the radiation dose significantly, while reducing the amount of iodine intake notably, thus reducing the incidence of adverse reaction.",2020,The radiation dose in group A was significantly less than that in the rest three groups (P<0.05).,['121 patients with body mass index (BMI) <26 kg/m 2  and heart rate (HR) <70 beats/min'],['low voltage and low concentration contrast agent'],"['signal-to-noise ratio (SNR) and contrast noise ratio (CNR', 'CT values', 'LCA SNR values', 'CT values and SD values of the aortic root (AR), subcutaneous fat, left coronary artery opening (LCA), and right coronary artery opening (RCA', 'CT values of AR', 'RCA CNR values', 'SNR, CNR and visual score', 'effective radiation dose and iodine intake', 'intake of iodine', 'image quality of coronary CT angiography, radiation dose and iodine intake', 'AR visual scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0439385', 'cui_str': 'beats per minute'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0009924', 'cui_str': 'Contrast Agents'}]","[{'cui': 'C2986823', 'cui_str': 'Signal-To-Noise Ratio'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0549113', 'cui_str': 'Supraaortic valve area structure'}, {'cui': 'C0222331', 'cui_str': 'Subcutaneous Fat'}, {'cui': 'C1261082', 'cui_str': 'Left coronary artery structure'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C1261316', 'cui_str': 'Right coronary artery structure'}, {'cui': 'C0610301', 'cui_str': 'RCA II'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0021968', 'cui_str': 'molecular iodine'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C1536105', 'cui_str': 'Angiography, CT'}]",121.0,0.0131779,The radiation dose in group A was significantly less than that in the rest three groups (P<0.05).,"[{'ForeName': 'Yue-Ying', 'Initials': 'YY', 'LastName': 'Pan', 'Affiliation': 'Department of Radiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China. xpyy02@sina.com.'}, {'ForeName': 'Shu-Chang', 'Initials': 'SC', 'LastName': 'Zhou', 'Affiliation': 'Department of Radiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China.'}, {'ForeName': 'Yu-Jin', 'Initials': 'YJ', 'LastName': 'Wang', 'Affiliation': 'Department of Radiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Radiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China.'}, {'ForeName': 'Ting-Ting', 'Initials': 'TT', 'LastName': 'Zhu', 'Affiliation': 'Department of Radiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China.'}, {'ForeName': 'Chun-Xia', 'Initials': 'CX', 'LastName': 'Liu', 'Affiliation': 'Department of Health Records, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China.'}, {'ForeName': 'Han-Xiong', 'Initials': 'HX', 'LastName': 'Guan', 'Affiliation': 'Department of Radiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China.'}]",Current medical science,['10.1007/s11596-020-2162-8']
116,31485039,Posterior capsule opacification and Nd:YAG laser rates with two hydrophobic acrylic single-piece IOLs.,"OBJECTIVES


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


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


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


Study findings suggest that PCO and Nd:YAG capsulotomy rates are significantly lower in eyes implanted with the EyeCee One IOL compared to the iMics1 IOL. Optic sharpness and lens material seem to be the decisive factors, while the stepped edge beneath the haptic junction appeared to be ineffective.",2020,A distinct gap between the anterior capsule and the IOL optic was present in 89% of eyes implanted with EyeCee One and 13% of iMics1 eyes.,"['80 patients with bilateral senile cataract', '39 patients (78 eyes) were evaluated after 3 years']","['hydrophobic acrylic single-piece intraocular Lenses (IOLs', 'hydrophobic acrylic single-piece IOLs', 'posterior capsule opacification (PCO) and Nd']","['PCO and Nd:YAG capsulotomy rates', 'Respective mean PCO scores', 'visual acuity, anterior fibrosis, capsule-optic edge interaction and distance between anterior and posterior capsule IOL surface', 'IOL optic', 'YAG capsulotomy rates', 'YAG capsulotomy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2025430', 'cui_str': 'Senile cataract of both eyes'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0440181', 'cui_str': 'Acrylic dental material (substance)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0023319', 'cui_str': 'Lenses, Intraocular'}, {'cui': 'C1444680', 'cui_str': 'Posterior capsule opacification'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0205154', 'cui_str': 'Along edge (qualifier value)'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}]",80.0,0.0689483,A distinct gap between the anterior capsule and the IOL optic was present in 89% of eyes implanted with EyeCee One and 13% of iMics1 eyes.,"[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Schartmüller', 'Affiliation': 'Department of Ophthalmology and Optometry of the Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Schriefl', 'Affiliation': 'Department of Ophthalmology and Optometry of the Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Schwarzenbacher', 'Affiliation': 'Department of Ophthalmology and Optometry of the Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Leydolt', 'Affiliation': 'Department of Ophthalmology and Optometry of the Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kundi', 'Affiliation': 'Center for Public Health, Medical University of Vienna, Kinderspitalgasse 15, 1090, Vienna, Austria.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Pieh', 'Affiliation': 'Department of Ophthalmology and Optometry of the Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria.'}, {'ForeName': 'Rupert', 'Initials': 'R', 'LastName': 'Menapace', 'Affiliation': 'Department of Ophthalmology and Optometry of the Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria. rupert.menapace@meduniwien.ac.at.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Kriechbaum', 'Affiliation': 'Department of Ophthalmology and Optometry of the Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria.'}]","Eye (London, England)",['10.1038/s41433-019-0569-x']
117,31490300,"Intralesional Triamcinolone May Not Be Beneficial for Treating Acute Hidradenitis Suppurativa Lesions: A Double-Blind, Randomized, Placebo-Controlled Trial.","BACKGROUND


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


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


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


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


No statistically significant difference was found between varying concentrations of triamcinolone and NS for the treatment of HS lesions. Steroid injections may be less effective for the management of acute HS than typically presumed.",2020,No statistically significant difference was found between varying concentrations of triamcinolone and NS for the treatment of HS lesions.,"['Acute Hidradenitis Suppurativa Lesions', 'Thirty-two subjects at University of North Carolina Dermatology and Skin Cancer Centers were enrolled for a total of 67 lesions']","['Placebo', 'Steroid injections', 'intralesional triamcinolone', 'placebo', 'Intralesional Triamcinolone', 'triamcinolone', 'intralesional triamcinolone 10 mg/mL, triamcinolone 40 mg/mL, and normal saline (NS']","['days to HS inflammatory lesion clearance, pain reduction', 'pain scores, days to resolution, and satisfaction', 'quality of life']","[{'cui': 'C0162836', 'cui_str': 'Acne Inversa'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0450357', 'cui_str': '32 (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0028407', 'cui_str': 'North Carolina'}, {'cui': 'C0011627', 'cui_str': 'Dermatology'}, {'cui': 'C0007114', 'cui_str': 'Cancer of Skin'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0040864', 'cui_str': 'Triamcinolone'}, {'cui': 'C0439294', 'cui_str': 'mcg/mcL'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C3872830', 'cui_str': 'Inflammatory lesion'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0034380'}]",32.0,0.695428,No statistically significant difference was found between varying concentrations of triamcinolone and NS for the treatment of HS lesions.,"[{'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Fajgenbaum', 'Affiliation': 'University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, NC.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Crouse', 'Affiliation': 'Department of Internal Medicine, Carolinas Medical Center, Chapel Hill, NC.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Dong', 'Affiliation': 'Department of Biostatistics, UNC Gillings School of Global Public Health, Chapel Hill, NC.'}, {'ForeName': 'Donglin', 'Initials': 'D', 'LastName': 'Zeng', 'Affiliation': 'Department of Biostatistics, UNC Gillings School of Global Public Health, Chapel Hill, NC.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Sayed', 'Affiliation': 'Department of Dermatology, University of North Carolina School of Medicine, Chapel Hill, NC.'}]",Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.],['10.1097/DSS.0000000000002112']
118,30609164,MRI analysis of fecal volume and dryness: Validation study using an experimental oxycodone-induced constipation model.,"BACKGROUND


Opioids are known to affect gastrointestinal motility, but their effect on fluid absorption and secretion is poorly understood in humans.
PURPOSE


To investigate the effect of oxycodone on colonic fecal volume and stool dryness by using a novel MRI-based technique.
STUDY TYPE


Prospective, randomized, double-blinded, crossover study.
SUBJECTS


Twenty-five healthy male volunteers (median age: 24 years [range: 21-56]; mean body mass index [BMI]: 23.9 kg/m 2  [range: 22.9-25.0]) without known gastrointestinal disease.
FIELD STRENGTH/SEQUENCE


T 2  -weighted and two-point Dixon MRI scans of the abdomen at 1.5 T.
ASSESSMENT


Subjects were treated for 5 days with prolonged-release oxycodone or a placebo. Imaging was performed on the first and last study day in each period. Images of the colon were analyzed with semiautomatic k-means-based segmentation software. Regional colonic fecal volumes were quantified excluding gas volume and colon wall. Two-point Dixon and T 2  -weighted MRI signal intensity were assessed as a proxy of colonic stool dryness. Data were obtained in a previously reported study.
STATISTICAL TESTS


Intraclass correlation coefficients were used to test the reliability of measurements between days, while repeated measures mixed models were applied to test treatment effects.
RESULTS


After oxycodone treatment, total colonic fecal volume was significantly increased compared with placebo (mean change 100 mL vs. -13 mL; P = 0.001), with the largest increase (24%) observed in the ascending colon/cecum (P = 0.001). Dixon signal increased (less water in colon content) after oxycodone treatment compared with placebo (mean 0.09 vs. -0.02; P < 0.001). T 2  -weighted signal decreased (less water in colon content) after oxycodone treatment compared with placebo (mean -0.03 vs. 0.03; P = 0.002).
DATA CONCLUSION


The 5-day oxycodone treatment increased colonic fecal volume and increased stool dryness compared with placebo. This imaging-based method for noninvasive analysis of colon content has the potential to characterize gastrointestinal symptoms in general, such as in constipation.
LEVEL OF EVIDENCE


2 Technical Efficacy Stage: 1 J. Magn. Reson. Imaging 2019;50:733-745.",2019,"T 2  -weighted signal decreased (less water in colon content) after oxycodone treatment compared with placebo (mean -0.03 vs. 0.03; P = 0.002).
","['experimental oxycodone-induced constipation model', 'Twenty-five healthy male volunteers (median age: 24 years [range: 21-56]; mean body mass index [BMI]: 23.9 kg/m 2  [range: 22.9-25.0]) without known gastrointestinal disease']","['oxycodone', 'mL', 'placebo', 'oxycodone or a placebo']","['MRI analysis of fecal volume and dryness', 'colonic stool dryness', 'colonic fecal volume and stool dryness', 'colonic fecal volume and increased stool dryness', 'T 2  -weighted signal', 'total colonic fecal volume', 'Regional colonic fecal volumes', 'Dixon signal']","[{'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C0017178', 'cui_str': 'Gastrointestinal Diseases'}]","[{'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C4552197', 'cui_str': 'Faecal volume'}, {'cui': 'C0009368', 'cui_str': 'Colon'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}]",25.0,0.10105,"T 2  -weighted signal decreased (less water in colon content) after oxycodone treatment compared with placebo (mean -0.03 vs. 0.03; P = 0.002).
","[{'ForeName': 'Esben B', 'Initials': 'EB', 'LastName': 'Mark', 'Affiliation': 'Mech-Sense, Department of Gastroenterology and Hepatology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Mark B', 'Initials': 'MB', 'LastName': 'Bødker', 'Affiliation': 'Mech-Sense, Department of Gastroenterology and Hepatology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Grønlund', 'Affiliation': 'Mech-Sense, Department of Gastroenterology and Hepatology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Lasse R', 'Initials': 'LR', 'LastName': 'Østergaard', 'Affiliation': 'Department of Health Science and Technology, Aalborg University, Aalborg Øst, Denmark.'}, {'ForeName': 'Jens B', 'Initials': 'JB', 'LastName': 'Frøkjaer', 'Affiliation': 'Mech-Sense, Department of Radiology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Asbjørn M', 'Initials': 'AM', 'LastName': 'Drewes', 'Affiliation': 'Mech-Sense, Department of Gastroenterology and Hepatology, Aalborg University Hospital, Aalborg, Denmark.'}]",Journal of magnetic resonance imaging : JMRI,['10.1002/jmri.26628']
119,30967640,Effect of early enteral nutrition on laparoscopic common bile duct exploration with enhanced recovery after surgery protocols.,"BACKGROUND/OBJECTIVES


Protocols for enhanced recovery after surgery (ERAS) provide comprehensive and evidence-based guidelines to improve perioperative care. It remains elusive whether early enteral nutrition (EEN) will play an active role in the ERAS protocols. Laparoscopic common bile duct exploration (LCBDE) is a safe and efficient method to treat patients with bile duct stones. This study aims to assess the safety, tolerability, and outcomes of EEN after LCBDE.
SUBJECTS /METHODS


From January 2014 to April 2017, a total of 100 patients with postoperative LCBDE were chosen and randomly divided into control group and EEN group. Patients in the control group were treated with traditional management with regular diet when tolerated, while patients in the EEN group were fed with EEN 3 h after LCBDE. The patients' characteristics, time to first flatus, complications, hospitalization stay, and hospitalization expenses were assessed and compared between patients in these two groups.
RESULTS


EEN accelerated the recovery of gastrointestinal function, being indicated by reduced time to first flatus when compared with control group (P = 0.00). In accordance, the quick recovery of gastrointestinal function resulted in shorter hospitalization stay for the EEN group (P = 0.00); however, no significant difference was shown when comparing the hospitalization expenses. On another hand, early oral feeding increased the occurrence of abdominal distension and diarrhea complications (P = 0.00 and P = 0.03).
CONCLUSIONS


EEN effectively improves gastrointestinal function, but raises complications such as abdominal distension and diarrhea after LCBDE. It is recommended to implement the EEN as early as possible if the patients are reasonably expected to have high compliance.",2019,"On another hand, early oral feeding increased the occurrence of abdominal distension and diarrhea complications (P = 0.00 and P = 0.03).
","['From January 2014 to April 2017, a total of 100 patients with postoperative LCBDE', 'patients with bile duct stones']","['traditional management with regular diet', 'early enteral nutrition', 'Laparoscopic common bile duct exploration (LCBDE', 'EEN 3\u2009h after LCBDE']","['hospitalization stay', 'time to first flatus, complications, hospitalization stay, and hospitalization expenses', 'reduced time to first flatus', 'recovery of gastrointestinal function', 'safety, tolerability', 'hospitalization expenses', 'occurrence of abdominal distension and diarrhea complications', 'gastrointestinal function']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0267869', 'cui_str': 'Calculus of bile duct (disorder)'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0184625', 'cui_str': 'Regular diet'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0086225', 'cui_str': 'Enteral Feeding'}, {'cui': 'C0009437', 'cui_str': 'Choledochus'}, {'cui': 'C1280903', 'cui_str': 'Exploration procedure'}, {'cui': 'C0041119', 'cui_str': 'Hydrogen-3'}]","[{'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0000731', 'cui_str': 'Swollen abdomen (finding)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",100.0,0.024763,"On another hand, early oral feeding increased the occurrence of abdominal distension and diarrhea complications (P = 0.00 and P = 0.03).
","[{'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Xiang', 'Affiliation': 'Department of Nutrition, Tianjin Nankai Hospital, Tianjin, China. xiangqixiangqi@163.com.'}, {'ForeName': 'Haicheng', 'Initials': 'H', 'LastName': 'Yuan', 'Affiliation': 'Department of Minimally Invasive Surgery, Tianjin Nankai Hospital, Tianjin, China.'}, {'ForeName': 'Wang', 'Initials': 'W', 'LastName': 'Cai', 'Affiliation': 'Department of Minimally Invasive Surgery, Tianjin Nankai Hospital, Tianjin, China.'}, {'ForeName': 'Shuo', 'Initials': 'S', 'LastName': 'Qie', 'Affiliation': 'Department of Biochemistry and Molecular Biology, Medical University of South Carolina, Charleston, USA.'}]",European journal of clinical nutrition,['10.1038/s41430-019-0425-x']
120,31260792,"A comparative effectiveness trial of two family-based childhood obesity treatment programs in a medically underserved region: Rationale, design & methods.","While there is a large body of literature documenting the efficacy of family-based childhood obesity (FBCO) treatment interventions, there is little evidence that these interventions have been systematically translated into regular practice - particularly in health disparate regions. To address this research-practice gap, this project was guided by a community advisory board (CAB) and the RE-AIM planning and evaluation framework within a systems-based and community-based participatory research approach. Families with overweight or obese children between 5 and 12 years old, in the medically-underserved Dan River Region, were randomly assigned to one of two FBCO treatment programs (iChoose vs. Family Connections) delivered by local Parks & Recreation staff. Both programs have previously demonstrated clinically meaningful child BMI z-score reductions, but vary in intensity, structure, and implementation demands. Two clinical CAB partners embedded recruitment methods into their regional healthcare organization, using procedures representative to what could be used if either program was taken to scale. The primary effectiveness outcome is child BMI z-scores at 6-months, with additional assessments at 3-months and at 12-months. Secondary goals are to determine: (1) reach into the intended audience; (2) effectiveness on secondary child and parent outcomes; (3) intervention adoption by organizations and staff; (4) fidelity, cost, and capacity for intervention implementation; and (5) maintenance of individual-level changes and organizational-level sustainability. This research addresses literature gaps related to the features within clinical and community settings that could improve both child weight status and the translation of FBCO interventions into typical practice in medically-underserved communities. IDENTIFIERS: Clincialtrials.gov: NCT03245775.",2019,"Both programs have previously demonstrated clinically meaningful child BMI z-score reductions, but vary in intensity, structure, and implementation demands.","['Families with overweight or obese children between 5 and 12\u202fyears old, in the medically-underserved Dan River Region', 'two family-based childhood obesity treatment programs in a medically underserved region']",['FBCO treatment programs (iChoose vs. Family Connections) delivered by local Parks & Recreation staff'],"['child BMI z-scores', 'meaningful child BMI z-score reductions', 'determine: (1) reach into the intended audience; (2) effectiveness on secondary child and parent outcomes; (3) intervention adoption by organizations and staff; (4) fidelity, cost, and capacity for intervention implementation; and (5) maintenance of individual-level changes and organizational-level sustainability']","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0337050', 'cui_str': 'Rivers'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2362324', 'cui_str': 'Childhood Onset Obesity'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0449379', 'cui_str': 'Connection (attribute)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0562547', 'cui_str': 'Park (environment)'}, {'cui': 'C0034872', 'cui_str': 'Recreation'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0001593', 'cui_str': 'Adoption'}, {'cui': 'C0220885', 'cui_str': 'organization'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",,0.0234096,"Both programs have previously demonstrated clinically meaningful child BMI z-score reductions, but vary in intensity, structure, and implementation demands.","[{'ForeName': 'Jamie M', 'Initials': 'JM', 'LastName': 'Zoellner', 'Affiliation': 'University of Virginia (UVA), Department of Public Health Sciences, UVA Cancer Center Research and Outreach Office, 16 East Main Street, Christiansburg, VA 24073, USA. Electronic address: Jz9q@virginia.edu.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'You', 'Affiliation': 'Virginia Tech, Department of Agricultural and Applied Economics, 304 Hutcheson Hall, 24060, USA.'}, {'ForeName': 'Jennie L', 'Initials': 'JL', 'LastName': 'Hill', 'Affiliation': 'Department of Epidemiology, University of Nebraska Medical Center, 986075 Nebraska Medical Center, Omaha, NE 68198-6075, USA.'}, {'ForeName': 'Donna-Jean P', 'Initials': 'DP', 'LastName': 'Brock', 'Affiliation': 'University of Virginia (UVA), Department of Public Health Sciences, UVA Cancer Center Research and Outreach Office, 16 East Main Street, Christiansburg, VA 24073, USA.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Yuhas', 'Affiliation': 'University of Virginia (UVA), Department of Public Health Sciences, UVA Cancer Center Research and Outreach Office, 16 East Main Street, Christiansburg, VA 24073, USA.'}, {'ForeName': 'Ramine C', 'Initials': 'RC', 'LastName': 'Alexander', 'Affiliation': 'Department of Family and Consumer Sciences, North Carolina A&T State University, Benbow 202-A, Greensboro, NC 27411, USA.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Price', 'Affiliation': 'UVA Cancer Center, Community Outreach and Education, Main Street, Unit 102, Danville, VA 24541, USA.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Estabrooks', 'Affiliation': 'Department of Health Promotion, University of Nebraska Medical Center, 986075 Nebraska Medical Center, Omaha, NE 68198-6075, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.06.015']
121,31260793,"REGENERATE: Design of a pivotal, randomised, phase 3 study evaluating the safety and efficacy of obeticholic acid in patients with fibrosis due to nonalcoholic steatohepatitis.","BACKGROUND


Nonalcoholic steatohepatitis (NASH) is a chronic, progressive, and severe form of nonalcoholic fatty liver disease. In FLINT, obeticholic acid (OCA) treatment improved multiple histological NASH features. The design and endpoints of REGENERATE, an ongoing phase 3 study, further evaluate OCA treatment in patients with fibrosis due to NASH.
AIMS


The Month 18 interim analysis assesses the effect of OCA on liver histology, defined as improvement of fibrosis by ≥1 stage with no worsening of NASH or resolution of NASH with no worsening of fibrosis. The end-of-study analyses evaluate the effect of OCA on mortality, liver-related clinical outcomes, and long-term safety.
METHODS


REGENERATE is a pivotal, long-term study of ~2400 patients with NASH, including ~2100 patients with stage 2 or 3 liver fibrosis. Additionally, ~300 patients with stage 1 fibrosis and ≥1 accompanying comorbidity are included to gather information on the safety of OCA and liver disease progression. Patients are randomised 1:1:1 to receive placebo or OCA (10 or 25 mg). A liver biopsy evaluation occurs at screening, Months 18 and 48, and end of study. The duration of the study is dependent upon accrual of a predetermined number of clinical outcome events.
CONCLUSIONS


REGENERATE is designed in conjunction with regulatory authorities to support regulatory approvals in NASH. This robust phase 3 study assesses the effect of OCA on liver histology as a surrogate for transplant-free survival and liver-related outcomes, including progression to cirrhosis and mortality, and will ultimately assess clinical benefit through specific evaluation of these outcomes.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov with the identifier NCT02548351.",2019,"The Month 18 interim analysis assesses the effect of OCA on liver histology, defined as improvement of fibrosis by ≥1 stage with no worsening of NASH or resolution of NASH with no worsening of fibrosis.","['patients with fibrosis due to nonalcoholic steatohepatitis', '2400 patients with NASH, including ~2100 patients with stage 2 or 3 liver fibrosis', '300 patients with stage 1 fibrosis and\u202f≥\u202f1 accompanying comorbidity', 'patients with fibrosis due to NASH']","['Nonalcoholic steatohepatitis (NASH', 'obeticholic acid', 'FLINT, obeticholic acid (OCA', 'OCA', 'placebo or OCA']","['safety of OCA and liver disease progression', 'mortality, liver-related clinical outcomes, and long-term safety', 'multiple histological NASH features']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C3241937', 'cui_str': 'Nonalcoholic Steatohepatitis'}, {'cui': 'C4517656', 'cui_str': 'Two thousand four hundred'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0239946', 'cui_str': 'Fibrosis, Liver'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}]","[{'cui': 'C3241937', 'cui_str': 'Nonalcoholic Steatohepatitis'}, {'cui': 'C1143018', 'cui_str': 'obeticholic acid'}, {'cui': 'C0303753', 'cui_str': 'Flintstone'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0023895', 'cui_str': 'Disorder of liver (disorder)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0205462', 'cui_str': 'Histologic (qualifier value)'}]",,0.138157,"The Month 18 interim analysis assesses the effect of OCA on liver histology, defined as improvement of fibrosis by ≥1 stage with no worsening of NASH or resolution of NASH with no worsening of fibrosis.","[{'ForeName': 'Vlad', 'Initials': 'V', 'LastName': 'Ratziu', 'Affiliation': ""Sorbonne Université, Hôpital Pitié - Salpêtrière, 91-105 Boulevard de l'Hôpital, 75013 Paris, France. Electronic address: vlad.ratziu@inserm.fr.""}, {'ForeName': 'Arun J', 'Initials': 'AJ', 'LastName': 'Sanyal', 'Affiliation': 'Department of Internal Medicine, Virginia Commonwealth University, 1101 E Marshall St, Richmond, VA, USA.'}, {'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Loomba', 'Affiliation': 'University of California, San Diego, 9500 Gilman Dr, La Jolla, CA, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Rinella', 'Affiliation': 'Division of Gastroenterology and Hepatology, Feinberg School of Medicine, Northwestern University, 676 N Saint Clair St, Chicago, IL, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Harrison', 'Affiliation': 'Pinnacle Clinical Research Center, 5109 Medical Dr. Ste 200, San Antonio, TX 78229, United States.'}, {'ForeName': 'Quentin M', 'Initials': 'QM', 'LastName': 'Anstee', 'Affiliation': 'Liver Research Group, Institute of Cellular Medicine, The Medical School, Newcastle University, Framlington Place, Newcastle-upon-Tyne, NE2 4HH, UK.'}, {'ForeName': 'Zachary', 'Initials': 'Z', 'LastName': 'Goodman', 'Affiliation': 'Betty and Guy Beatty Center for Integrated Research, Inova Health System, Claude Moore Health Education and Research Building, 3300 Gallows Rd, Falls Church, VA, USA.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Bedossa', 'Affiliation': ""Service d'Anatomie Pathologique, Hôpital Beaujon, Assistance Publique-Hôpitaux de Paris, INSERM UMR 1149-CRI, Université Denis Diderot Paris-7, 46 rue Henri Huchard, 75018 Clichy, France.""}, {'ForeName': 'Leigh', 'Initials': 'L', 'LastName': 'MacConell', 'Affiliation': 'Intercept Pharmaceuticals, 4760 Eastgate Mall, San Diego, CA, USA.'}, {'ForeName': 'Reshma', 'Initials': 'R', 'LastName': 'Shringarpure', 'Affiliation': 'Intercept Pharmaceuticals, 4760 Eastgate Mall, San Diego, CA, USA.'}, {'ForeName': 'Amrik', 'Initials': 'A', 'LastName': 'Shah', 'Affiliation': 'Intercept Pharmaceuticals, 4760 Eastgate Mall, San Diego, CA, USA.'}, {'ForeName': 'Zobair', 'Initials': 'Z', 'LastName': 'Younossi', 'Affiliation': 'Betty and Guy Beatty Center for Integrated Research, Inova Health System, Claude Moore Health Education and Research Building, 3300 Gallows Rd, Falls Church, VA, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.06.017']
122,31279778,"BEST: Bypass equipoise sleeve trial; rationale and design of a randomized, registry-based, multicenter trial comparing Roux-en-Y gastric bypass with sleeve gastrectomy.","BACKGROUND


Laparoscopic gastric bypass (LGBP) is a well-documented surgical intervention for severe obesity. Recently, laparoscopic sleeve gastrectomy (LSG) has gained increased popularity. Short-term follow-up in limited-sized randomized trials comparing LGBP and LSG show no major differences in weight-loss, adverse events, or effect on comorbidities; however, there is a lack of sufficiently powered, pragmatic, randomized controlled trials comparing the mid- and long-term results of the two methods.
METHOD


BEST is a randomized, registry-based, multicenter trial comparing LGBP and LSG. The trial has two primary outcomes; rates of substantial complications (SC) and total body weight loss. We hypothesize that patients treated with LSG will experience 35% fewer substantial complications during the 5-year follow-up compared to patients treated with LGBP, and that the efficacy of LSG will remain within a non-inferiority margin of 5% in terms of weight loss. Our sample size calculation, using data from the Scandinavian Obesity Surgery Registry (SOReg), shows a power of 80% for SC and > 95% for weight loss at p < .025 with a total of 2100 included patients. The design of the trial will also enable comparisons within several relevant patient subgroups.
CONCLUSIONS


As a large-sized, pragmatic, randomized trial, BEST will provide robust data comparing LGBP with LSG by generating long-term results on weight loss and SC's, as well as secondary outcomes and comparisons within patient subgroups. The use of a well-established registry for registration of all data facilitates a large multicenter trial, and combines the strengths of registry studies with those of a randomized trial. Clinical Trials registry: NCT02767505.",2019,"Short-term follow-up in limited-sized randomized trials comparing LGBP and LSG show no major differences in weight-loss, adverse events, or effect on comorbidities; however, there is a lack of sufficiently powered, pragmatic, randomized controlled trials comparing the mid- and long-term results of the two methods.
",[],"['LSG', 'laparoscopic sleeve gastrectomy (LSG', 'Laparoscopic gastric bypass (LGBP', 'LGBP and LSG', 'LGBP', 'Roux-en-Y gastric bypass with sleeve gastrectomy']","['weight loss', 'rates of substantial complications (SC) and total body weight loss', 'weight-loss, adverse events', ""weight loss and SC's"", 'substantial complications']",[],"[{'cui': 'C1960816', 'cui_str': 'Laparoscopic sleeve gastrectomy'}, {'cui': 'C4039248', 'cui_str': 'Laparoscopic bypass of stomach'}, {'cui': 'C0585179', 'cui_str': 'Roux-en-Y Gastric Bypass'}, {'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",2100.0,0.193481,"Short-term follow-up in limited-sized randomized trials comparing LGBP and LSG show no major differences in weight-loss, adverse events, or effect on comorbidities; however, there is a lack of sufficiently powered, pragmatic, randomized controlled trials comparing the mid- and long-term results of the two methods.
","[{'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Hedberg', 'Affiliation': 'Department of Gastrosurgical Research and Education, Institute of Clinical Sciences, The Sahlgrenska Academy, University of Gothenburg, Sweden; Department of Surgery at Östra Sjukhuset, Sahlgrenska University Hospital, Gothenburg, Sweden. Electronic address: suzanne.hedberg@vgregion.se.'}, {'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Olbers', 'Affiliation': 'Department of Surgery and Department of Clinical and Experimental Medicine, Linköping University, Norrköping, Sweden.'}, {'ForeName': 'Markku', 'Initials': 'M', 'LastName': 'Peltonen', 'Affiliation': 'National Institute of Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Österberg', 'Affiliation': 'Department of Surgery, Mora Hospital, Mora, Sweden; Department of Clinical Sciences, Intervention and Technology (CLINTEC), Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Wirén', 'Affiliation': 'Department of Surgery and Department of Clinical and Experimental Medicine, Linköping University, Norrköping, Sweden.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Ottosson', 'Affiliation': 'Department of Surgery, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Thorell', 'Affiliation': 'Karolinska Institutet, Department of Clinical Sciences, Danderyds Hospital and Department of Surgery, Ersta Hospital, Stockholm, Sweden.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Contemporary clinical trials,['10.1016/j.cct.2019.07.001']
123,31859034,The 11+ Kids warm-up programme to prevent injuries in young Iranian male high-level football (soccer) players: A cluster-randomised controlled trial.,"OBJECTIVE


To assess the effectiveness of the 11+ Kids warm-up programme regarding injury reduction in male high-level children's football players.
DESIGN


Cluster-randomised controlled trial.
METHOD


Male youth football teams of Iran's high-level football schools were invited to participate. Inclusion criteria were: teams are competing in the highest league of their province; players are between 7 and 14 years old; regular training takes place at least twice per week. Teams were excluded if they used an injury prevention measure. Participating clubs were randomised to an intervention (INT, N = 20 teams) and a control group (CON, N = 22 teams), stratified by the number of teams and the age group. The groups were blinded against each other. The follow-up period was one season (9 months). INT replaced their warm-up by 11+ Kids. CON performed a standard warm-up programme. The primary outcome was the injury incidence density (injuries per 1000 h of football exposure), compared between groups by incidence rate ratios (RR).
RESULTS


In total, 64,047 h of football exposure of 962 players (INT = 443 players, 31,934 h of football, CON = 519 players, 32,113 h of football) were recorded. During the study, 90 (INT = 30; CON = 60) injuries occurred. The overall injury incidence density in INT was reduced by 50% compared to CON (RR 0.50; 95%-CI 0.32, 0.78). No injuries occurred during the execution of the intervention exercises.
CONCLUSIONS


The 11+ Kids reduces injuries in high-level children's football players, thus supporting player health and potentially performance and player development.",2020,"The overall injury incidence density in INT was reduced by 50% compared to CON (RR 0.50; 95%-CI 0.32, 0.78).","['young Iranian male high-level football (soccer) players', 'Inclusion criteria were: teams are competing in the highest league of their province; players are between 7 and 14 years old; regular training takes place at least twice per week', ""Male youth football teams of Iran's high-level football schools were invited to participate"", ""male high-level children's football players"", 'In total, 64,047\u202fh of football exposure of 962 players (INT\u202f=\u202f443 players, 31,934\u202fh of football, CON\u202f=\u202f519 players, 32,113\u202fh of football) were recorded']","['CON', '11+ Kids warm-up programme']","['incidence rate ratios (RR', 'injury incidence density (injuries per 1000\u202fh of football exposure', 'overall injury incidence density in INT']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0554962', 'cui_str': 'Iranian (NMO) (ethnic group)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0336986', 'cui_str': 'Football'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}]","[{'cui': 'C0184348', 'cui_str': 'Warmer'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C0336986', 'cui_str': 'Football'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.0619136,"The overall injury incidence density in INT was reduced by 50% compared to CON (RR 0.50; 95%-CI 0.32, 0.78).","[{'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Zarei', 'Affiliation': 'Department of Sport Rehabilitation and Health, Faculty of Sport Science, Shahid Beheshti University, Tehran, Iran.'}, {'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Abbasi', 'Affiliation': 'Department of Sport Injuries and Corrective Exercises, Sport Sciences Research Institute, Tehran, Iran.'}, {'ForeName': 'Parisa', 'Initials': 'P', 'LastName': 'Namazi', 'Affiliation': 'Department of Sport Rehabilitation and Health, Faculty of Sport Science, Shahid Beheshti University, Tehran, Iran.'}, {'ForeName': 'Mojtaba', 'Initials': 'M', 'LastName': 'Asgari', 'Affiliation': 'Institute of Sport and Sports Science, TU Dortmund University, Germany.'}, {'ForeName': 'Nikki', 'Initials': 'N', 'LastName': 'Rommers', 'Affiliation': 'Department of Movement and Sports Sciences, Vrije Universiteit Brussel, Belgium; Department of Movement and Sports Sciences, Ghent University, Belgium; Research Foundation Flanders (FWO), Belgium; Amsterdam Collaboration on Health & Safety in Sports & Department of Public and Occupational Health, Amsterdam Movement Sciences, VU University Medical Center, Netherlands.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Rössler', 'Affiliation': 'Amsterdam Collaboration on Health & Safety in Sports & Department of Public and Occupational Health, Amsterdam Movement Sciences, VU University Medical Center, Netherlands; Department of Sport, Exercise, and Health, University of Basel, Switzerland. Electronic address: roland.roessler@unibas.ch.'}]",Journal of science and medicine in sport,['10.1016/j.jsams.2019.12.001']
124,31524303,Acute Shame Predicts Urges for Suicide but not for Substance Use in a Veteran Population.,"OBJECTIVE


There is an urgent need to identify ways to reduce rates of suicide among Veterans with a substance use disorder. Since co-occurring disorders can make diagnosis and treatment complex, it is useful for the mental health field to examine common factors that may underlie both problems. One common factor that underlies both substance use and suicidal behavior is shame. This brief report presents data collected in an experimental study examining shame as an acute risk factor for suicide and substance use in Veterans.
METHOD


Thirty-eight Veterans admitted to an inpatient Veterans Affairs Medical Center unit with suicidal ideation completed measures on depression, hopelessness, addiction, and suicidality. Participants were randomized to either a shame mood induction group or a control group, and completed pre- and postexperiment measures on urges for suicide, urges for substance use, and level of shame.
RESULTS


Results indicate that an acute increase in shame resulted in an increase in an urge for suicide, but was not associated with changes in urges for substance use.
CONCLUSIONS


Acute feelings of shame may be a risk factor for increases in suicidal ideation. Limitations and suggestions for future directions are discussed.",2020,"RESULTS


Results indicate that an acute increase in shame resulted in an increase in an urge for suicide, but was not associated with changes in urges for substance use.
","['Veterans with a substance use disorder', 'Thirty-eight Veterans admitted to an inpatient Veterans Affairs Medical Center unit with suicidal ideation completed measures on depression, hopelessness, addiction, and suicidality']","['shame mood induction group or a control group, and completed pre- and postexperiment measures']",['urge for suicide'],"[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0038586', 'cui_str': 'Substance Use Disorders'}, {'cui': 'C0450361', 'cui_str': '38 (qualifier value)'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0424000', 'cui_str': 'Suicidal Ideation'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0150041', 'cui_str': 'Feeling of hopelessness'}, {'cui': 'C0085281', 'cui_str': 'Addictive Behavior'}]","[{'cui': 'C0036938', 'cui_str': 'Shame'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]","[{'cui': 'C0852733', 'cui_str': 'Suicide (accomplished)'}]",38.0,0.0204817,"RESULTS


Results indicate that an acute increase in shame resulted in an increase in an urge for suicide, but was not associated with changes in urges for substance use.
","[{'ForeName': 'Amy Y', 'Initials': 'AY', 'LastName': 'Cameron', 'Affiliation': 'Department of Veterans Affairs, VA Medical Center, Providence, RI, USA.'}, {'ForeName': 'M Tracie', 'Initials': 'MT', 'LastName': 'Shea', 'Affiliation': 'Department of Veterans Affairs, VA Medical Center, Providence, RI, USA.'}, {'ForeName': 'Alyson B', 'Initials': 'AB', 'LastName': 'Randall', 'Affiliation': 'Butler Hospital, Providence, RI, USA.'}]",Suicide & life-threatening behavior,['10.1111/sltb.12588']
125,31537504,Prospective Comparison of 70-kVp Single-Energy CT versus Dual-Energy CT: Which is More Suitable for CT Angiography with Low Contrast Media Dosage?,"RATIONALE AND OBJECTIVES


To compare the objective and subjective image qualities between single-energy computed tomography (CT) at 70 kVp and virtual monoenergetic imaging (VMI) of dual-source dual-energy CT for CT angiography with 180 mgI/kg.
MATERIALS AND METHODS


Total 63 patients scanned with 180 mgI/kg were randomly divided into two groups: Group A (32 patients) underwent CT angiography at 70-kVp, and Group B (31 patients) underwent dual-energy CT. VMI sets were generated at 10-keV increments between 40 and 100 keV. We calculated aortic attenuation, contrast-to-noise-ratio (CNR), signal-to-noise-ratio, figure of merit of CNR, and effective dose for each protocol. Three radiologists scored overall image quality and various arteries' visibility using a four-point scale. Quantitative and qualitative comparisons between 70 kVp and VMI with the highest CNR were performed with the two-tailed t test or Kruskal-Wallis test.
RESULTS


The 40-keV images offered the highest CNR among VMIs. Aortic attenuation at 70 kVp was significantly lower than that at 40 keV (p < 0.001). However, the signal-to-noise-ratio, CNR, and figure of merit of CNR were significantly higher at 70 kVp than those at 40-keV (p < 0.001, p < 0.05, and p < 0.05, respectively). The effective dose of each group was almost equal. The qualitative visibility scores for various arteries, except the ascending and upper-abdominal aorta, were also better at 70 kVp than those at 40 keV.
CONCLUSION


Aortic attenuation at 70 kVp with 180 mg I/kg was lower than that of VMI at 40 keV, and the objective and subjective image qualities were higher at 70 kVp than those at 40 keV.",2020,"The qualitative visibility scores for various arteries, except the ascending and upper-abdominal aorta, were also better at 70 kVp than those at 40 keV.
CONCLUSION


",['Total 63 patients scanned with 180 mgI/kg'],"['70-kVp Single-Energy CT versus Dual-Energy CT', 'single-energy computed tomography (CT) at 70 kVp and virtual monoenergetic imaging (VMI) of dual-source dual-energy CT for CT angiography with 180 mgI/kg', 'CT angiography at 70-kVp, and Group B (31 patients) underwent dual-energy CT']","['signal-to-noise-ratio, CNR, and figure of merit of CNR', 'Aortic attenuation', 'calculated aortic attenuation, contrast-to-noise-ratio (CNR), signal-to-noise-ratio, figure of merit of CNR, and effective dose', 'qualitative visibility scores', 'objective and subjective image qualities']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441633'}, {'cui': 'C4319557', 'cui_str': '180'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C4521696', 'cui_str': 'Source (property)'}, {'cui': 'C1536105', 'cui_str': 'Angiography, CT'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C2986823', 'cui_str': 'Signal-To-Noise Ratio'}, {'cui': 'C0003483', 'cui_str': 'Aorta'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0205556', 'cui_str': 'Qualitative (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]",63.0,0.0199655,"The qualitative visibility scores for various arteries, except the ascending and upper-abdominal aorta, were also better at 70 kVp than those at 40 keV.
CONCLUSION


","[{'ForeName': 'Morikatsu', 'Initials': 'M', 'LastName': 'Yoshida', 'Affiliation': 'Department of Radiology, Amakusa Medical Center, 854-1 Jikiba, Kameba, Amakusa, Kumamoto 863-0046, Japan. Electronic address: y_morikatsu@hotmail.com.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Nakaura', 'Affiliation': 'Department of Diagnostic Radiology, Faculty of Life Sciences, Kumamoto University, Kumamoto, Kumamoto, Japan.'}, {'ForeName': 'Takada', 'Initials': 'T', 'LastName': 'Sentaro', 'Affiliation': 'Department of Radiology, Amakusa Medical Center, 854-1 Jikiba, Kameba, Amakusa, Kumamoto 863-0046, Japan.'}, {'ForeName': 'Shota', 'Initials': 'S', 'LastName': 'Tanoue', 'Affiliation': 'Department of Diagnostic Radiology, Faculty of Life Sciences, Kumamoto University, Kumamoto, Kumamoto, Japan.'}, {'ForeName': 'Hatsuki', 'Initials': 'H', 'LastName': 'Inada', 'Affiliation': 'Department of Radiology, Amakusa Medical Center, 854-1 Jikiba, Kameba, Amakusa, Kumamoto 863-0046, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Utsunomiya', 'Affiliation': 'Department of Radiology, Yokohama City University School of Medicine, Yokohama, Kanagawa, Japan.'}, {'ForeName': 'Naritsugu', 'Initials': 'N', 'LastName': 'Sakaino', 'Affiliation': 'Department of Cardiovascular Internal Medicine, Amakusa Medical Center, Amakusa, Kumamoto, Japan.'}, {'ForeName': 'Kazunori', 'Initials': 'K', 'LastName': 'Harada', 'Affiliation': 'Department of Surgery, Amakusa Medical Center, Amakusa, Kumamoto, Japan.'}, {'ForeName': 'Yasuyuki', 'Initials': 'Y', 'LastName': 'Yamashita', 'Affiliation': 'Department of Diagnostic Radiology, Faculty of Life Sciences, Kumamoto University, Kumamoto, Kumamoto, Japan.'}]",Academic radiology,['10.1016/j.acra.2019.07.016']
126,30365024,Measurement of Electronic Cigarette Frequency of Use Among Smokers Participating in a Randomized Controlled Trial.,"BACKGROUND


The United States Food and Drug Administration has prioritized understanding the dependence potential of electronic cigarettes (e-cigs). Dependence is often estimated in part by examining frequency of use; however measures of e-cig use are not well developed because of varying product types. This study used an e-cig automatic puff counter to evaluate the value of self-reported e-cig use measures in predicting actual use (puffs).
METHODS


Data were collected from a two-site randomized placebo-controlled trial evaluating the effects of e-cigs on toxicant exposure in smokers attempting to reduce their cigarette consumption. Participants randomized to an e-cig condition self-reported their e-cig frequency of use (times per day-one ""time"" consists of around 15 puffs or lasts around 10 minutes) on the Penn State Electronic Cigarette Dependence Index (PSECDI) and kept daily diary records of the number of puffs per day from the e-cig automatic puff counter. A linear mixed-effects model was used to determine the predictive value of the times per day measure. Correlations were used to further investigate the relationship.
RESULTS


A total of 259 participants with 1165 observations of e-cig use were analyzed. Self-reported e-cig use in times per day was a significant predictor of e-cig puffs per day (p < .01). The Spearman correlation between measures was r equal to .58. Examination of individual participant responses revealed some potential difficulties reporting and interpreting times per day because of the difference in use patterns between cigarettes and e-cigs.
CONCLUSION


This study provides evidence that the self-reported PSECDI measure of times per day is a significant predictor of actual frequency of e-cig puffs taken.
IMPLICATIONS


Self-reported measures of e-cig frequency of use are predictive of actual use, but quantifying e-cig use in patterns similar to cigarettes is problematic.",2020,Self-reported e-cig use in times per day was a significant predictor of e-cig puffs per day (p<.01).,"['smokers attempting to reduce their cigarette consumption', '259 participants with 1165 observations of e-cig use were analyzed', 'smokers participating']","['e-cig condition self-reported their e-cig frequency of use (times per day - one ""time"" consists of around 15 puffs or lasts around 10 minutes) on the Penn State Electronic Cigarette Dependence Index (PSECDI', 'placebo']",[],"[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0459840', 'cui_str': 'Cigarette consumption (observable entity)'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C4280017', 'cui_str': 'E-Cig Use'}]","[{'cui': 'C3849993', 'cui_str': 'Electronic Cigarettes'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0205447', 'cui_str': '1'}, {'cui': 'C1533107', 'cui_str': 'Puffs'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0439857', 'cui_str': 'Patient dependence on (contextual qualifier) (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]",[],259.0,0.038409,Self-reported e-cig use in times per day was a significant predictor of e-cig puffs per day (p<.01).,"[{'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Yingst', 'Affiliation': 'Penn State Tobacco Center of Regulatory Science, Pennsylvania State University, Hershey, PA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Foulds', 'Affiliation': 'Penn State Tobacco Center of Regulatory Science, Pennsylvania State University, Hershey, PA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Veldheer', 'Affiliation': 'Penn State Tobacco Center of Regulatory Science, Pennsylvania State University, Hershey, PA.'}, {'ForeName': 'Caroline O', 'Initials': 'CO', 'LastName': 'Cobb', 'Affiliation': 'Department of Psychology, Virginia Commonwealth University, Richmond, VA.'}, {'ForeName': 'Miao-Shan', 'Initials': 'MS', 'LastName': 'Yen', 'Affiliation': 'Center for the Study of Tobacco Products, Virginia Commonwealth University, Richmond, VA.'}, {'ForeName': 'Shari', 'Initials': 'S', 'LastName': 'Hrabovsky', 'Affiliation': 'Penn State Tobacco Center of Regulatory Science, Pennsylvania State University, Hershey, PA.'}, {'ForeName': 'Sophia I', 'Initials': 'SI', 'LastName': 'Allen', 'Affiliation': 'Penn State Tobacco Center of Regulatory Science, Pennsylvania State University, Hershey, PA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Bullen', 'Affiliation': 'University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Eissenberg', 'Affiliation': 'Department of Psychology, Virginia Commonwealth University, Richmond, VA.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/nty233']
127,31226405,Keys to staying sharp: A randomized clinical trial of piano training among older adults with and without mild cognitive impairment.,"BACKGROUND


The prevalence of dementia, the most expensive medical condition (Kirschstein, 2000 and Hurd et al., 2013 [1,2]), and its precursor, mild cognitive impairment (MCI) are increasing [3]. Finding effective intervention strategies to prevent or delay dementia is imperative to public health. Prior research provides compelling evidence that central auditory processing (CAP) deficits are a risk factor for dementia [4-6]. Grounded in the information degradation theory [7, 8], we hypothesize that improving brain function at early perceptual levels (i.e., CAP) may be optimal to attenuate cognitive and functional decline and potentially curb dementia prevalence. Piano training is one avenue to enhance cognition [9-13] by facilitating CAP at initial perceptual stages [14-18].
OBJECTIVES


The Keys To Staying Sharp study is a two arm, randomized clinical trial examining the efficacy of piano training relative to music listening instruction to improve CAP, cognition, and everyday function among older adults. In addition, the moderating effects of MCI status on piano training efficacy will be examined and potential mediators of intervention effects will be explored.
HYPOTHESES


We hypothesize that piano training will improve CAP and cognitive performance, leading to functional improvements. We expect that enhanced CAP will mediate cognitive gains. We further hypothesize that cognitive gains will mediate functional improvements.
METHOD


We plan to enroll 360 adults aged 60 years and older who will be randomized to piano training or an active control condition of music listening instruction and complete pre- and immediate post- assessments of CAP, cognition, and everyday function.",2019,Prior research provides compelling evidence that central auditory processing (CAP) deficits are a risk factor for dementia [4-6].,"['360 adults aged 60\u202fyears and older who will be randomized to', 'older adults with and without mild cognitive impairment', 'older adults']","['piano training or an active control condition of music listening instruction and complete pre- and immediate post- assessments of CAP, cognition, and everyday function', 'piano training relative to music listening instruction', 'Piano training', 'piano training']","['CAP, cognition, and everyday function', 'CAP and cognitive performance']","[{'cui': 'C4319607', 'cui_str': '360 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0179586', 'cui_str': 'Cap (physical object)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}]","[{'cui': 'C0179586', 'cui_str': 'Cap (physical object)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0031843', 'cui_str': 'function'}]",360.0,0.0510187,Prior research provides compelling evidence that central auditory processing (CAP) deficits are a risk factor for dementia [4-6].,"[{'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Hudak', 'Affiliation': 'Department of Psychiatry and Behavioral Neurosciences, University of South Florida. Electronic address: ehudak@health.usf.edu.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Bugos', 'Affiliation': 'School of Music, University of South Florida.'}, {'ForeName': 'Ross', 'Initials': 'R', 'LastName': 'Andel', 'Affiliation': 'School of Aging Studies, University of South Florida; Department of Neurology, Charles University and Motol University Hospital, Prague, Czech Republic.'}, {'ForeName': 'Jennifer J', 'Initials': 'JJ', 'LastName': 'Lister', 'Affiliation': 'Department of Communication Sciences and Disorders, University of South Florida.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Ji', 'Affiliation': 'College of Nursing, University of South Florida.'}, {'ForeName': 'Jerri D', 'Initials': 'JD', 'LastName': 'Edwards', 'Affiliation': 'Department of Psychiatry and Behavioral Neurosciences, University of South Florida; Department of Communication Sciences and Disorders, University of South Florida.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.06.003']
128,31437539,Defining Optimal Care for Functional Gut Disorders - Multi-Disciplinary Versus Standard Care: A Randomized Controlled Trial Protocol.,"BACKGROUND


Functional gastrointestinal disorders (FGIDs) are the commonest reason for gastroenterological consultation, with patients usually seen by a specialist working in isolation. There is a wealth of evidence testifying to the benefit provided by dieticians, behavioral therapists, hypnotherapists and psychotherapists in treating these conditions, yet they rarely form a part of the therapeutic team, and these treatment modalities are rarely offered as part of the therapeutic management. There has been little examination of different models of care for FGIDs. We hypothesize that multi-disciplinary integrated care is superior to standard specialist-based care in the treatment of functional gut disorders.
METHODS


The ""MANTRA"" (Multidisciplinary Treatment for Functional Gut Disorders) study compares comprehensive multi-disciplinary outpatient care with standard hospital outpatient care. Consecutive new referrals to the gastroenterology and colorectal outpatient clinics of a single secondary and tertiary care hospital of patients with an FGID, defined by the Rome IV criteria, will be included. Patients will be prospectively randomized 2:1 to multi-disciplinary (gastroenterologist, gut-hypnotherapist, psychiatrist, behavioral therapist ('biofeedback') and dietician) or standard care (gastroenterologist or colorectal surgeon). Patients are assessed up to 12 months after completing treatment. The primary outcome is an improvement on a global assessment scale at the end of treatment. Symptoms, quality of life, psychological well-being, and healthcare costs are secondary outcome measures.
DISCUSSION


There have been few studies examining how best to deliver care for functional gut disorders. The MANTRA study will define the clinical and cost benefits of two different models of care for these highly prevalent disorders.
TRIAL REGISTRATION NUMBER


Clinicaltrials.govNCT03078634 Registered on Clinicaltrials.gov, completed recruitment, registered on March 13th 2017. Ethics and Dissemination: Ethical approval has been received by the St Vincent's Hospital Melbourne human research ethics committee (HREC-A 138/16). The results will be disseminated in peer-reviewed journals and presented at international conferences. Protocol version 1.2.",2019,"We hypothesize that multi-disciplinary integrated care is superior to standard specialist-based care in the treatment of functional gut disorders.
","['Consecutive new referrals to the gastroenterology and colorectal outpatient clinics of a single secondary and tertiary care hospital of patients with an FGID, defined by the Rome IV criteria, will be included']","['comprehensive multi-disciplinary outpatient care with standard hospital outpatient care', ""multi-disciplinary (gastroenterologist, gut-hypnotherapist, psychiatrist, behavioral therapist ('biofeedback') and dietician) or standard care (gastroenterologist or colorectal surgeon""]","['global assessment scale', 'Symptoms, quality of life, psychological well-being, and healthcare costs']","[{'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0017163', 'cui_str': 'Gastroenterology'}, {'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0002423', 'cui_str': 'Outpatient Care'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0259901', 'cui_str': 'Gastroenterologist'}, {'cui': 'C0871774', 'cui_str': 'Hypnotherapist'}, {'cui': 'C0033872', 'cui_str': 'Psychiatrist'}, {'cui': 'C0678663', 'cui_str': 'Biofeedback, function (observable entity)'}, {'cui': 'C3536818', 'cui_str': 'Dietitian'}, {'cui': 'C0586901', 'cui_str': 'Colorectal surgeon (occupation)'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales (assessment scale)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034380'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}]",,0.0842227,"We hypothesize that multi-disciplinary integrated care is superior to standard specialist-based care in the treatment of functional gut disorders.
","[{'ForeName': 'Chamara', 'Initials': 'C', 'LastName': 'Basnayake', 'Affiliation': ""Department of Gastroenterology, St Vincent's Hospital, Melbourne, Australia; University of Melbourne, Melbourne, Australia. Electronic address: Chamara.basnayake@svha.org.au.""}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Kamm', 'Affiliation': ""Department of Gastroenterology, St Vincent's Hospital, Melbourne, Australia; University of Melbourne, Melbourne, Australia. Electronic address: mkamm@unimelb.edu.au.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Salzberg', 'Affiliation': 'University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Khera', 'Affiliation': ""Department of Gastroenterology, St Vincent's Hospital, Melbourne, Australia; University of Melbourne, Melbourne, Australia. Electronic address: Anglea.khera@svha.org.au.""}, {'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'Liew', 'Affiliation': 'Monash University, Melbourne, Australia. Electronic address: Danny.liew@monash.edu.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Burrell', 'Affiliation': ""Department of Gastroenterology, St Vincent's Hospital, Melbourne, Australia. Electronic address: Kathryn.burrell@svha.org.au.""}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': ""Wilson-O'Brien"", 'Affiliation': ""Department of Gastroenterology, St Vincent's Hospital, Melbourne, Australia; University of Melbourne, Melbourne, Australia. Electronic address: amy.wilson-obrien@svha.org.au.""}, {'ForeName': 'Annalise', 'Initials': 'A', 'LastName': 'Stanley', 'Affiliation': ""Department of Gastroenterology, St Vincent's Hospital, Melbourne, Australia. Electronic address: Annalise.stanley@svha.org.au.""}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Talley', 'Affiliation': 'University of Newcastle, Newcastle, Australia. Electronic address: nicholas.talley@newcastle.edu.au.'}, {'ForeName': 'Alexander J', 'Initials': 'AJ', 'LastName': 'Thompson', 'Affiliation': ""Department of Gastroenterology, St Vincent's Hospital, Melbourne, Australia; University of Melbourne, Melbourne, Australia. Electronic address: Alexander.thompson@svha.org.au.""}]",Contemporary clinical trials,['10.1016/j.cct.2019.105828']
129,31843441,"We have the injury prevention exercise programme, but how well do youth follow it?","OBJECTIVES


Describe the exercise fidelity and utilisation fidelity of the Knee Control injury prevention exercise programme (IPEP) in youth floorball alongside an intervention RCT.
DESIGN


Observation study METHODS: 20 floorball team training groups (12 male, 8 female, age 12-17 years) from the intervention arm of an RCT were included. The Knee Control IPEP was implemented at the beginning of the season. A research team member attended a team training session twice in the season (first and second half of 26 week season) with a total 31 training sessions observed. An IPEP specific exercise fidelity checklist was used to assess how the programme was used.
RESULTS


Of 535 individual Knee Control exercises observed (76% of observations in males), 58% were performed correctly. Exercise fidelity was higher in females than in males (71% vs 54%, proportion difference 16%, 95% CI 7-25%, P=0.001). The full Knee Control IPEP (7 exercises x 3 sets) was completed only during 4 of 31 (13%) training sessions observed. The utilisation fidelity did not differ between sexes, and the mean number of completed exercises performed during the observations was 11 (SD 5).
CONCLUSIONS


The exercise fidelity to an IPEP in youth floorball players was low, with only three out of five exercises performed according to instructions. Furthermore, only half of the IPEP exercises were executed on average. To make IPEPs effective in youth floorball and other similar team-ball sports, more work is needed to understand the reasons for low exercise and utilisation fidelity.",2020,"Exercise fidelity was higher in females than in males (71% vs 54%, proportion difference 16%, 95% CI 7-25%, P=0.001).","['20 floorball team training groups (12 male, 8 female, age 12-17 years) from the intervention arm of an RCT were included', 'youth floorball players']",['Knee Control injury prevention exercise programme (IPEP'],"['utilisation fidelity', 'exercise fidelity and utilisation fidelity', 'Exercise fidelity', 'full Knee Control IPEP']","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0087178', 'cui_str': 'Youth'}]","[{'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0150638', 'cui_str': 'Preventing injury (procedure)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",,0.0305363,"Exercise fidelity was higher in females than in males (71% vs 54%, proportion difference 16%, 95% CI 7-25%, P=0.001).","[{'ForeName': 'Nirmala K P', 'Initials': 'NKP', 'LastName': 'Perera', 'Affiliation': 'Division of Physiotherapy, Department of Medical and Health Sciences, Linköping University, Sweden; Sport Without Injury ProgrammE (SWIPE), Linköping University, Sweden; Centre for Sport, Exercise and Osteoarthritis Research Versus Arthritis, Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom; School of Allied Health, Human Services and Sport, Latrobe University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Hägglund', 'Affiliation': 'Division of Physiotherapy, Department of Medical and Health Sciences, Linköping University, Sweden; Sport Without Injury ProgrammE (SWIPE), Linköping University, Sweden. Electronic address: martin.hagglund@liu.se.'}]",Journal of science and medicine in sport,['10.1016/j.jsams.2019.11.008']
130,32331356,Connectivity of Real-Time Video Counselling Versus Telephone Counselling for Smoking Cessation in Rural and Remote Areas: An Exploratory Study.,"This study compared the connectivity of video sessions to telephone sessions delivered to smokers in rural areas and whether remoteness and video app (video only) were associated with the connectivity of video or telephone sessions. Participants were recruited into a randomised trial where two arms offered smoking cessation counselling via: (a) real-time video communication software (201 participants) or (b) telephone (229 participants). Participants were offered up to six video or telephone sessions and the connectivity of each session was recorded. A total of 456 video sessions and 606 telephone sessions were completed. There was adequate connectivity of the video intervention in terms of no echoing noise (97.8%), no loss of internet connection during the session (88.6%), no difficulty hearing the participant (88.4%) and no difficulty seeing the participant (87.5%). In more than 94% of telephone sessions, there was no echoing noise, no difficulty hearing the participant and no loss of telephone line connection. Video sessions had significantly greater odds of experiencing connectivity difficulties than telephone sessions in relation to connecting to the participant at the start (odds ratio, OR = 5.13, 95% confidence interval, CI 1.88-14.00), loss of connection during the session (OR = 11.84, 95% CI 4.80-29.22) and hearing the participant (OR = 2.53, 95% CI 1.41-4.55). There were no significant associations between remoteness and video app and connectivity difficulties in the video or telephone sessions. Real-time video sessions are a feasible option for smoking cessation providers to provide support in rural areas.",2020,"Video sessions had significantly greater odds of experiencing connectivity difficulties than telephone sessions in relation to connecting to the participant at the start (odds ratio, OR = 5.13, 95% confidence interval, CI 1.88-14.00), loss of connection during the session (OR = 11.84, 95% CI 4.80-29.22) and hearing the participant (OR = 2.53, 95% CI 1.41-4.55).","['229 participants', 'Smoking Cessation in Rural and Remote Areas']","['Real-Time Video Counselling Versus Telephone Counselling', 'smoking cessation counselling via: (a) real-time video communication software (201 participants) or (b) telephone']","['loss of connection', 'no loss of internet connection', 'remoteness and video app and connectivity difficulties', 'experiencing connectivity difficulties']","[{'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0037585', 'cui_str': 'Software'}]","[{'cui': 'C0449379', 'cui_str': 'Connection'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]",,0.0278314,"Video sessions had significantly greater odds of experiencing connectivity difficulties than telephone sessions in relation to connecting to the participant at the start (odds ratio, OR = 5.13, 95% confidence interval, CI 1.88-14.00), loss of connection during the session (OR = 11.84, 95% CI 4.80-29.22) and hearing the participant (OR = 2.53, 95% CI 1.41-4.55).","[{'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Byaruhanga', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, University Drive, Callaghan, New South Wales 2308, Australia.'}, {'ForeName': 'Christine L', 'Initials': 'CL', 'LastName': 'Paul', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, University Drive, Callaghan, New South Wales 2308, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Wiggers', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, University Drive, Callaghan, New South Wales 2308, Australia.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Byrnes', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, University Drive, Callaghan, New South Wales 2308, Australia.'}, {'ForeName': 'Aimee', 'Initials': 'A', 'LastName': 'Mitchell', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, University Drive, Callaghan, New South Wales 2308, Australia.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Lecathelinais', 'Affiliation': 'Hunter New England Population Health, Hunter New England Local Health District, Locked Mail Bag 10, Wallsend, New South Wales 2287, Australia.'}, {'ForeName': 'Flora', 'Initials': 'F', 'LastName': 'Tzelepis', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, University Drive, Callaghan, New South Wales 2308, Australia.'}]",International journal of environmental research and public health,['10.3390/ijerph17082891']
131,32331366,"Effects of the Healthy Children, Healthy Families, Healthy Communities Program for Obesity Prevention among Vulnerable Children: A Cluster-Randomized Controlled Trial.","Background : We aimed to examine whether the Healthy Children, Healthy Families, and Healthy Communities Program, consisting of multi-level strategies for obesity prevention tailoring the context of socioeconomically vulnerable children based on an ecological perspective, would be effective on improving their healthy lifestyle behaviors and obesity status.  Methods : Participants were 104 children (and 59 parents) enrolled in public welfare systems in Seoul, South Korea. Based on a cluster-randomized controlled trial (no. ISRCTN11347525), eight centers were randomly assigned to intervention (four centers, 49 children, 27 parents) versus control groups (four centers, 55 children, 32 parents). Multi-level interventions of child-, parent-, and center-level strategies were conducted for 12 weeks. Children's healthy lifestyle behaviors and obesity status were assessed as daily recommended levels and body mass index ≥85th percentile, respectively. Parents' parenting behaviors were measured by the Family Nutrition and Physical Activity scale.  Results : Compared to the control group, the intervention group showed significant improvements in total composite scores of healthy-lifestyle behaviors-including 60-min of moderate physical activity-but not in obesity status among children. Moreover, the intervention group showed significant improvements in parenting behaviors among parents.  Conclusion : The multi-level strategies for obesity prevention based on an ecological perspective may be effective for promoting healthy lifestyles among socioeconomically vulnerable children.",2020,"Compared to the control group, the intervention group showed significant improvements in total composite scores of healthy-lifestyle behaviors-including 60-min of moderate physical activity-but not in obesity status among children.","['Participants were 104 children (and 59 parents) enrolled in public welfare systems in Seoul, South Korea', 'socioeconomically vulnerable children', 'Healthy Children, Healthy Families, and Healthy Communities Program', 'Healthy Children, Healthy Families, Healthy Communities Program for Obesity Prevention among Vulnerable Children']",[],"['total composite scores of healthy-lifestyle behaviors-including 60-min of moderate physical activity', 'Family Nutrition and Physical Activity scale', 'parenting behaviors', ""Children's healthy lifestyle behaviors and obesity status"", ""Parents' parenting behaviors""]","[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0037440', 'cui_str': 'Social services'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C3850150', 'cui_str': 'Seoul'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C0425119', 'cui_str': 'Child at risk'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}]",[],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}]",104.0,0.03545,"Compared to the control group, the intervention group showed significant improvements in total composite scores of healthy-lifestyle behaviors-including 60-min of moderate physical activity-but not in obesity status among children.","[{'ForeName': 'Jina', 'Initials': 'J', 'LastName': 'Choo', 'Affiliation': 'Department of Community Health Nursing, College of Nursing, Korea University, Seoul 02841, Korea.'}, {'ForeName': 'Hwa-Mi', 'Initials': 'HM', 'LastName': 'Yang', 'Affiliation': 'Department of Community Health Nursing, College of Nursing, Korea University, Seoul 02841, Korea.'}, {'ForeName': 'Sae-Young', 'Initials': 'SY', 'LastName': 'Jae', 'Affiliation': 'Department of Sport Science, University of Seoul, Seoul 02504, Korea.'}, {'ForeName': 'Hye-Jin', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Department of Community Health Nursing, College of Nursing, Korea University, Seoul 02841, Korea.'}, {'ForeName': 'Jihyun', 'Initials': 'J', 'LastName': 'You', 'Affiliation': 'Department of Community Health Nursing, College of Nursing, Korea University, Seoul 02841, Korea.'}, {'ForeName': 'Juneyoung', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Biostatistics, College of Medicine, Korea University, Seoul 02841, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17082895']
132,32061833,Associations of Caregiver-Oncologist Discordance in Prognostic Understanding With Caregiver-Reported Therapeutic Alliance and Anxiety.,"CONTEXT


Discordance in prognostic understanding between caregivers of adults with advanced cancer and the oncologist may shape caregivers' views of the oncologist and bereavement outcomes.
OBJECTIVES


We examined prospective associations of caregiver-oncologist discordance with caregiver-oncologist therapeutic alliance and caregiver anxiety after patient death.
METHODS


We conducted a secondary analysis of data collected in a cluster randomized controlled trial from August 2012 to June 2014 in Western New York and California. At enrollment, caregivers and oncologists used a seven-point scale to rate their beliefs about the patient's curability and living two years or more: 100%, about 90%, about 75%, about 50 of 50, about 25%, about 10%, and 0%. Discordance was defined as a difference of two points or more. Outcomes at seven months after patient death included caregiver-oncologist therapeutic alliance (The Human Connection scale, modified into five items) and caregiver anxiety (Generalized Anxiety Disorder-7). We conducted multivariable linear regression models to assess the independent associations of discordance with alliance and anxiety.
RESULTS


We included 97 caregivers (mean age 63) and 38 oncologists; 41% of caregiver-oncologist dyads had discordant beliefs about the patient's curability, and 63% of caregiver-oncologist dyads had discordant beliefs about living two years or more. On multivariate analysis, discordance in beliefs about curability was associated with lower anxiety (β = -2.20; SE 0.77; P = 0.005). Discordance in beliefs about length of life was associated with a weaker alliance (β = -5.87; SE = 2.56; P = 0.02).
CONCLUSION


A better understanding of how caregivers understand and come to terms with poor prognoses will guide interventions to improve cancer care delivery and outcomes of cancer treatment.",2020,"On multivariate analysis, discordance in beliefs about curability was associated with lower anxiety (β=-2.20, SE=0.77, p=0.005).","['caregivers of adults with advanced cancer', 'caregiver-oncologist discordance with caregiver-oncologist therapeutic alliance and caregiver anxiety following patient death', 'August 2012 to June 2014 in Western New York and California', ""97 caregivers (mean age=63) and 38 oncologists; 41% of caregiver-oncologist dyads had discordant beliefs about the patient's curability and 63% of caregiver-oncologist dyads had discordant beliefs about living ≥2 years""]",[],"['Discordance in beliefs about length of life', 'caregiver-oncologist therapeutic alliance [modified 5-item Human Connection (THC) scale] and caregiver anxiety (Generalized Anxiety Disorder-7']","[{'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0259990', 'cui_str': 'Oncologists'}, {'cui': 'C0814487', 'cui_str': 'Therapeutic Alliance'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",[],"[{'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0023980', 'cui_str': 'Length of Life'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0259990', 'cui_str': 'Oncologists'}, {'cui': 'C0814487', 'cui_str': 'Therapeutic Alliance'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0449379', 'cui_str': 'Connection (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}]",97.0,0.0754677,"On multivariate analysis, discordance in beliefs about curability was associated with lower anxiety (β=-2.20, SE=0.77, p=0.005).","[{'ForeName': 'Kah Poh', 'Initials': 'KP', 'LastName': 'Loh', 'Affiliation': 'James P Wilmot Cancer Institute, University of Rochester School of Medicine and Dentistry, Rochester, New York, USA. Electronic address: kahpoh_loh@urmc.rochester.edu.'}, {'ForeName': 'Huiwen', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'James P Wilmot Cancer Institute, University of Rochester School of Medicine and Dentistry, Rochester, New York, USA.'}, {'ForeName': 'Ronald M', 'Initials': 'RM', 'LastName': 'Epstein', 'Affiliation': 'James P Wilmot Cancer Institute, University of Rochester School of Medicine and Dentistry, Rochester, New York, USA; Department of Family Medicine, University of Rochester School of Medicine and Dentistry, Rochester, New York, USA; Department of Psychiatry, University of Rochester School of Medicine and Dentistry, Rochester, New York, USA; Department of Medicine, Palliative Care, University of Rochester School of Medicine and Dentistry, Rochester, New York, USA.'}, {'ForeName': 'Supriya G', 'Initials': 'SG', 'LastName': 'Mohile', 'Affiliation': 'James P Wilmot Cancer Institute, University of Rochester School of Medicine and Dentistry, Rochester, New York, USA.'}, {'ForeName': 'Holly G', 'Initials': 'HG', 'LastName': 'Prigerson', 'Affiliation': 'Division of Geriatrics and Palliative Medicine, Department of Medicine, Weill Cornell Medicine, New York, New York, USA; Cornell Center for Research on End-of-Life Care, New York, New York, USA.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Plumb', 'Affiliation': 'James P Wilmot Cancer Institute, University of Rochester School of Medicine and Dentistry, Rochester, New York, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Ladwig', 'Affiliation': 'Department of Medicine, Palliative Care, University of Rochester School of Medicine and Dentistry, Rochester, New York, USA.'}, {'ForeName': 'Sindhuja', 'Initials': 'S', 'LastName': 'Kadambi', 'Affiliation': 'James P Wilmot Cancer Institute, University of Rochester School of Medicine and Dentistry, Rochester, New York, USA.'}, {'ForeName': 'Melisa L', 'Initials': 'ML', 'LastName': 'Wong', 'Affiliation': 'Division of Hematology/Oncology, Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'McHugh', 'Affiliation': 'James P Wilmot Cancer Institute, University of Rochester School of Medicine and Dentistry, Rochester, New York, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'An', 'Affiliation': 'Department of Medicine, Palliative Care, University of Rochester School of Medicine and Dentistry, Rochester, New York, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Trevino', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Memorial Sloan Kettering Cancer Center, New York, New York, USA.'}, {'ForeName': 'Fahad', 'Initials': 'F', 'LastName': 'Saeed', 'Affiliation': 'Department of Medicine, Palliative Care, University of Rochester School of Medicine and Dentistry, Rochester, New York, USA; Division of Nephrology, Department of Medicine, University of Rochester School of Medicine and Dentistry, Rochester, New York, USA.'}, {'ForeName': 'Paul R', 'Initials': 'PR', 'LastName': 'Duberstein', 'Affiliation': 'Department of Health Behavior, Society, and Policy, Rutgers School of Public Health, Piscataway, New Jersey, USA.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2020.02.005']
133,31562660,Caring E-mails for Military and Veteran Suicide Prevention: A Randomized Controlled Trial.,"OBJECTIVE


The purpose of this multisite study was to conduct a randomized controlled trial of an e-mail version of the caring letters (CL) suicide prevention intervention to determine whether the intervention is efficacious in preventing suicide behaviors among U.S. service members and veterans.
METHOD


Psychiatric inpatients (N = 1,318) were recruited from four military medical centers and two VA hospitals and randomized to receive either 13 caring e-mails over two years or usual care.
RESULTS


There were 10 deaths from any cause in the CL group (three suicides) and 14 in the usual care group (seven suicides) during the individual two-year follow-up intervals. There was no statistically significant difference in the rate of all-cause hospital readmission between the study groups (RR = 1.13; 95% CI = 0.94, 1.36). There were no differences observed between groups on self-reported psychiatric hospital readmissions, self-reported suicide attempts, or other measures associated with risk for suicide.
CONCLUSIONS


No firm conclusions about the efficacy of the intervention can be made because the study was inadequately powered. There were no adverse events associated with the intervention, and implementation of the procedures was feasible in the military and veteran hospital settings. These results provide important methodological considerations for caring contact trials in military populations.",2020,"There were no adverse events associated with the intervention, and implementation of the procedures was feasible in the military and veteran hospital settings.","['U.S. service members and veterans', 'Psychiatric inpatients (N\xa0=\xa01,318) were recruited from four military medical centers and two VA hospitals']","['13 caring e-mails over two years or usual care', 'e-mail version of the caring letters (CL) suicide prevention intervention']","['self-reported psychiatric hospital readmissions, self-reported suicide attempts, or other measures associated with risk for suicide', 'suicide behaviors', 'rate of all-cause hospital readmission']","[{'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0026126', 'cui_str': 'Armed Forces Personnel'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C0204732', 'cui_str': 'Suicide prevention (procedure)'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0020021', 'cui_str': 'Mental Hospitals'}, {'cui': 'C0038663', 'cui_str': 'Suicide attempt (event)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0852733', 'cui_str': 'Suicide (accomplished)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0600290', 'cui_str': 'Hospital Readmissions'}]",13.0,0.0809188,"There were no adverse events associated with the intervention, and implementation of the procedures was feasible in the military and veteran hospital settings.","[{'ForeName': 'David D', 'Initials': 'DD', 'LastName': 'Luxton', 'Affiliation': 'National Center for Telehealth & Technology, Joint Base Lewis-McChord, Tacoma, WA, USA.'}, {'ForeName': 'Derek J', 'Initials': 'DJ', 'LastName': 'Smolenski', 'Affiliation': 'Defense Health Agency, Psychological Health Center of Excellence, Tacoma, WA, USA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Reger', 'Affiliation': 'National Center for Telehealth & Technology, Joint Base Lewis-McChord, Tacoma, WA, USA.'}, {'ForeName': 'Rona Margaret V', 'Initials': 'RMV', 'LastName': 'Relova', 'Affiliation': 'VA Palo Alto Health Care System, Palo Alto, CA, USA.'}, {'ForeName': 'Nancy A', 'Initials': 'NA', 'LastName': 'Skopp', 'Affiliation': 'Defense Health Agency, Psychological Health Center of Excellence, Tacoma, WA, USA.'}]",Suicide & life-threatening behavior,['10.1111/sltb.12589']
134,31217579,Management of primary pterygium with intra-lesional injection of 5 flurouracil and bevacizumab (Avastin).,"BACKGROUND


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


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


The injection of 5 fluorouracil and Avastin act synergistically to arrest progression and induce atrophy in primary pterygium. This is related to the effect of agents on fibroblasts, collagen, and vascular tissues. Such medical intervention is a safe and viable option in the management of primary pterygium though excision of residual tissue is still required in some cases. Longer follow up is needed to ascertain whether this will reduce the recurrence rate following excision.",2019,"VEGF, bFGF, EGF, vWF, LYVE-1 and collagen-I were all reduced in the injected samples.
","['primary pterygium', 'Fourteen eyes of 14 patients', 'primary pterygium with intra-lesional injection of 5', 'Sixteen eyes with primary pterygium']","['combined 5FU and Avastin injections', 'intralesional 5 fluorouracil and Avastin', 'primary pterygium who did not receive injections (control) and subjected to immunohistological examination for beta fibroblast growth factor (bFGF', 'fluorouracil and Avastin', 'flurouracil and bevacizumab (Avastin']","['Pterygium progression', 'vascular endothelial growth factor (VEGF), epidermal growth factor (EGF), von-Willebrand factor (vWF), lymphatic vessel endothelial hyaluronan receptor (LYVE-1) and collagen-I', 'redness', 'VEGF, bFGF, EGF, vWF, LYVE-1 and collagen-I', 'recurrence rate']","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0033999', 'cui_str': 'Pterygium'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C3715157', 'cui_str': '16'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C1135130', 'cui_str': 'Avastin'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0033999', 'cui_str': 'Pterygium'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C0016026', 'cui_str': 'DNA Synthesis Factor'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]","[{'cui': 'C0033999', 'cui_str': 'Pterygium'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C0242275', 'cui_str': 'Epidermal Growth Factor'}, {'cui': 'C0042971', 'cui_str': 'von Willebrand factor'}, {'cui': 'C0229889', 'cui_str': 'Structure of lymphatic vessel'}, {'cui': 'C0243982', 'cui_str': 'Hyaluronan Receptors'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0332575', 'cui_str': 'Red color (finding)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}]",,0.0193891,"VEGF, bFGF, EGF, vWF, LYVE-1 and collagen-I were all reduced in the injected samples.
","[{'ForeName': 'Noha', 'Initials': 'N', 'LastName': 'Ghoz', 'Affiliation': 'Academic section of ophthalmology, Division of Clinical Neuroscience, University of Nottingham and Department of Ophthalmology, Nottingham University Hospitals, NHS Trust, Nottingham, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Britton', 'Affiliation': 'Academic section of ophthalmology, Division of Clinical Neuroscience, University of Nottingham and Department of Ophthalmology, Nottingham University Hospitals, NHS Trust, Nottingham, UK.'}, {'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Ross', 'Affiliation': 'Academic section of ophthalmology, Division of Clinical Neuroscience, University of Nottingham and Department of Ophthalmology, Nottingham University Hospitals, NHS Trust, Nottingham, UK.'}, {'ForeName': 'Imran', 'Initials': 'I', 'LastName': 'Mohammed', 'Affiliation': 'Academic section of ophthalmology, Division of Clinical Neuroscience, University of Nottingham and Department of Ophthalmology, Nottingham University Hospitals, NHS Trust, Nottingham, UK.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Hogan', 'Affiliation': 'Academic section of ophthalmology, Division of Clinical Neuroscience, University of Nottingham and Department of Ophthalmology, Nottingham University Hospitals, NHS Trust, Nottingham, UK.'}, {'ForeName': 'Dalia G', 'Initials': 'DG', 'LastName': 'Said', 'Affiliation': 'Academic section of ophthalmology, Division of Clinical Neuroscience, University of Nottingham and Department of Ophthalmology, Nottingham University Hospitals, NHS Trust, Nottingham, UK.'}, {'ForeName': 'Harminder S', 'Initials': 'HS', 'LastName': 'Dua', 'Affiliation': 'Academic section of ophthalmology, Division of Clinical Neuroscience, University of Nottingham and Department of Ophthalmology, Nottingham University Hospitals, NHS Trust, Nottingham, UK. harminder.dua@nottingham.ac.uk.'}]","Eye (London, England)",['10.1038/s41433-019-0493-0']
135,31439877,Feasibility of conducting an active exercise prehabilitation program in patients awaiting spinal stenosis surgery: a randomized pilot study.,"Prehabilitation is defined as the process of augmenting functional capacity before surgery in preparation for the postoperative phase. This study intends to assess the feasibility of conducting a preoperative intervention program in patients with lumbar spinal stenosis and to report on the piloting of the proposed intervention. Patients were allocated to a 6-week supervised preoperative rehabilitation program or a control group. The intervention included supervised exercise sessions aimed to improve strength, muscular endurance, and spinal stabilization. Outcomes were measured at baseline, 6 weeks later and again 6 weeks, 3 months and 6 months after surgery. Sixty-five percent of admissible participants agreed to take part in the study, of which 5% dropped out before the end of the intervention period. Eighty-eight percent of potential training sessions were delivered without adverse event. Improvements were seen in favour of the experimental group at the preoperative assessment for active ranges of motion, leg pain intensity, lumbar extensor muscle endurance and walking capacities. Results show that slight modifications to the choice of outcome measures would increase feasibility of the main study. The absence of adverse events coupled with positive changes seen in dependant outcome measures warrant the conduct of a full-scale trial assessing the effectiveness of the intervention.",2019,"Improvements were seen in favour of the experimental group at the preoperative assessment for active ranges of motion, leg pain intensity, lumbar extensor muscle endurance and walking capacities.","['patients awaiting spinal stenosis surgery', 'patients with lumbar spinal stenosis']","['active exercise prehabilitation program', 'supervised preoperative rehabilitation program or a control group', 'supervised exercise sessions aimed to improve strength, muscular endurance, and spinal stabilization', 'preoperative intervention program']","['active ranges of motion, leg pain intensity, lumbar extensor muscle endurance and walking capacities']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0037944', 'cui_str': 'Spinal Stenosis'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0158288', 'cui_str': 'Spinal stenosis of lumbar region (disorder)'}]","[{'cui': 'C0419117', 'cui_str': 'Active exercise (regime/therapy)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0442025', 'cui_str': 'Muscular (qualifier value)'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}]","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0023222', 'cui_str': 'Pain in lower limb (finding)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0024090', 'cui_str': 'Lumbar Region'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}]",,0.0270679,"Improvements were seen in favour of the experimental group at the preoperative assessment for active ranges of motion, leg pain intensity, lumbar extensor muscle endurance and walking capacities.","[{'ForeName': 'Andrée-Anne', 'Initials': 'AA', 'LastName': 'Marchand', 'Affiliation': 'Department of Anatomy, Université du Québec à Trois-Rivières, Trois-Rivières, Canada. andree-anne.marchand@uqtr.ca.'}, {'ForeName': 'Margaux', 'Initials': 'M', 'LastName': 'Suitner', 'Affiliation': 'Department of Human Kinetics, Université du Québec à Trois-Rivières, Trois-Rivières, Canada.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': ""O'Shaughnessy"", 'Affiliation': 'Department of Chiropractic, Université du Québec à Trois-Rivières, Trois-Rivières, Canada.'}, {'ForeName': 'Claude-Édouard', 'Initials': 'CÉ', 'LastName': 'Châtillon', 'Affiliation': 'Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec, Trois-Rivières, Canada.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Cantin', 'Affiliation': 'Department of Human Kinetics, Université du Québec à Trois-Rivières, Trois-Rivières, Canada.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Descarreaux', 'Affiliation': 'Department of Human Kinetics, Université du Québec à Trois-Rivières, Trois-Rivières, Canada.'}]",Scientific reports,['10.1038/s41598-019-48736-7']
136,31444404,Low-molecular-weight-heparin increases Th1- and Th17-associated chemokine levels during pregnancy in women with unexplained recurrent pregnancy loss: a randomised controlled trial.,"Low-molecular-weight heparin (LMWH) is widely used to treat recurrent pregnancy loss (RPL) because of its anti-coagulant effects. Although in vitro studies have suggested additional immunological effects, these are debated. We therefore investigated whether LMWH could modulate immune responses in vivo during pregnancy of women with unexplained RPL. A Swedish open multi-centre randomised controlled trial included 45 women treated with tinzaparin and 42 untreated women. Longitudinally collected plasma samples were obtained at gestational weeks (gw) 6, 18, 28 and 34 and analysed by multiplex bead technology for levels of 11 cytokines and chemokines, chosen to represent inflammation and T-helper subset-associated immunity. Mixed linear models test on LMWH-treated and untreated women showed differences during pregnancy of the Th1-associated chemokines CXCL10 (p = 0.01), CXCL11 (p < 0.001) and the Th17-associated chemokine CCL20 (p = 0.04), while CCL2, CCL17, CCL22, CXCL1, CXCL8, CXCL12, CXCL13 and IL-6 did not differ. Subsequent Student's t-test showed significantly higher plasma levels of CXCL10 and CXCL11 in treated than untreated women at gw 28 and 34. The consistent increase in the two Th1-associated chemokines suggests a potential proinflammatory and unfavourable effect of LMWH treatment during later stages of pregnancy, when Th1 immunity is known to disrupt immunological tolerance.",2019,Subsequent Student's t-test showed significantly higher plasma levels of CXCL10 and CXCL11 in treated than untreated women at gw 28 and 34.,"['women with unexplained RPL', '45 women treated with', 'women with unexplained recurrent pregnancy loss', 'and 42 untreated women']","['LMWH', 'tinzaparin', 'Low-molecular-weight heparin (LMWH']","['Th17-associated chemokine CCL20', 'CCL2, CCL17, CCL22, CXCL1, CXCL8, CXCL12, CXCL13', 'CXCL11', 'plasma levels of CXCL10 and CXCL11']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C2921106', 'cui_str': 'Recurrent pregnancy loss'}]","[{'cui': 'C0019139', 'cui_str': 'LMWH'}, {'cui': 'C0216278', 'cui_str': 'tinzaparin'}]","[{'cui': 'C1961104', 'cui_str': 'Small Inducible Cytokine A20'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",45.0,0.211614,Subsequent Student's t-test showed significantly higher plasma levels of CXCL10 and CXCL11 in treated than untreated women at gw 28 and 34.,"[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Rasmark Roepke', 'Affiliation': 'Department of Obstetrics and Gynecology, Skåne University Hospital, Malmö and Lund University, Lund, Sweden. emma_36@hotmail.com.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Bruno', 'Affiliation': 'Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Nedstrand', 'Affiliation': 'Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Boij', 'Affiliation': 'Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.'}, {'ForeName': 'C Petersson', 'Initials': 'CP', 'LastName': 'Strid', 'Affiliation': 'Departmen of Obstetrics and Gynecology, Kalmar Hospital, Kalmar, Sweden.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Piccione', 'Affiliation': 'Section of Gynecology and Obstetrics, Academic Department of Biomedicine and Prevention, and Clinical Department of Surgery, Tor Vergata University Hospital, Rome, Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Berg', 'Affiliation': 'Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Svensson-Arvelund', 'Affiliation': 'Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.'}, {'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'Jenmalm', 'Affiliation': 'Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rubér', 'Affiliation': 'Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Ernerudh', 'Affiliation': 'Department of Clinical Immunology and Transfusion Medicine, and Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.'}]",Scientific reports,['10.1038/s41598-019-48799-6']
137,31451704,"Rice bran extract supplement improves sleep efficiency and sleep onset in adults with sleep disturbance: A randomized, double-blind, placebo-controlled, polysomnographic study.","We previously reported that rice bran extract supplement (RBS) administration to mice decreased sleep latency and induced non-rapid eye movement (NREM) sleep via inhibition of the histamine H 1  receptor. Based on this, we performed the first clinical trial to investigate whether RBS would be beneficial to subjects with disturbed sleep. We performed a randomized, double-blinded, placebo-controlled, 2-week study. Fifty subjects with sleep disturbance were enrolled and received either RBS (1,000 mg/day) or placebo. Polysomnography was performed, and Pittsburgh Sleep Quality Index, Epworth Sleepiness Scale (ESS), and Fatigue Severity Scale were administered at the initiation and termination of the study. Compared with the placebo, RBS led to significant polysomnographic changes, including decreased sleep latency (adjusted, P = 0.047), increased total sleep time (P = 0.019), and improved sleep efficiency (P = 0.010). Additionally, the amount of stage 2 sleep significantly increased in the RBS group. When adjusted for caffeine intake, wakefulness after sleep onset, total wake time, and delta activity tended to decrease in the RBS group. RBS administration decreased ESS scores. There were no reported serious adverse events in both groups. RBS improved sleep in adults with sleep disturbance. Trial registration: WHO ICTRP, KCT0001893.",2019,There were no reported serious adverse events in both groups.,"['subjects with disturbed sleep', 'adults with sleep disturbance', 'Fifty subjects with sleep disturbance']","['placebo', 'RBS', 'Rice bran extract supplement', 'placebo, RBS', 'rice bran extract supplement (RBS']","['serious adverse events', 'RBS improved sleep', 'sleep efficiency and sleep onset', 'sleep latency and induced non-rapid eye movement (NREM) sleep via inhibition', 'Pittsburgh Sleep Quality Index, Epworth Sleepiness Scale (ESS), and Fatigue Severity Scale', 'ESS scores', 'total sleep time', 'sleep efficiency', 'sleep latency', 'amount of stage 2 sleep', 'caffeine intake, wakefulness after sleep onset, total wake time, and delta activity']","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnias'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3810876', 'cui_str': 'Rice bran'}, {'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C4505222', 'cui_str': 'REM Sleep Latency'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0234451', 'cui_str': 'Sleep, Slow-Wave'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C3697468', 'cui_str': 'PSQI - Pittsburgh sleep quality index'}, {'cui': 'C3541276', 'cui_str': 'ESS - Epworth Sleepiness Scale'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0043012', 'cui_str': 'Wakefulnesses'}, {'cui': 'C0442696', 'cui_str': 'Waking (observable entity)'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",50.0,0.3013,There were no reported serious adverse events in both groups.,"[{'ForeName': 'Min Young', 'Initials': 'MY', 'LastName': 'Um', 'Affiliation': 'Research division of functional food functionality, Korea Food Research Institute, Wanju, 55365, Republic of Korea.'}, {'ForeName': 'Hyejin', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'Research division of functional food functionality, Korea Food Research Institute, Wanju, 55365, Republic of Korea.'}, {'ForeName': 'Jin Kyu', 'Initials': 'JK', 'LastName': 'Han', 'Affiliation': 'Seoul Sleep Center, Seoul, 06041, Republic of Korea.'}, {'ForeName': 'Jin Young', 'Initials': 'JY', 'LastName': 'Kim', 'Affiliation': 'Department of Nursing, Seoul National University, Seoul, 03080, Republic of Korea.'}, {'ForeName': 'Seung Wan', 'Initials': 'SW', 'LastName': 'Kang', 'Affiliation': 'Department of Nursing, Seoul National University, Seoul, 03080, Republic of Korea.'}, {'ForeName': 'Minseok', 'Initials': 'M', 'LastName': 'Yoon', 'Affiliation': 'Research division of functional food functionality, Korea Food Research Institute, Wanju, 55365, Republic of Korea.'}, {'ForeName': 'Sangoh', 'Initials': 'S', 'LastName': 'Kwon', 'Affiliation': 'S&D Research and Development Institute, Cheongju, 28156, Republic of Korea.'}, {'ForeName': 'Suengmok', 'Initials': 'S', 'LastName': 'Cho', 'Affiliation': 'Department of Food Science and Technology, Pukyong National University, Busan, 48513, Republic of Korea. scho@pknu.ac.kr.'}]",Scientific reports,['10.1038/s41598-019-48743-8']
138,32329033,A Multilevel Diabetes and CVD Risk Reduction Intervention in African American Churches: Project Faith Influencing Transformation (FIT) Feasibility and Outcomes.,"Wide-reaching health promotion interventions are needed in influential, accessible community settings to address African American (AA) diabetes and CVD disparities. Most AAs are overweight/obese, which is a primary clinical risk factor for diabetes/CVD. Using a faith-community-engaged approach, this study examined feasibility and outcomes of Project Faith Influencing Transformation (FIT), a diabetes/CVD screening, prevention, and linkage to care pilot intervention to increase weight loss in AA church-populations at 8 months. Six churches were matched and randomized to multilevel FIT intervention or standard education control arms. Key multilevel religiously tailored FIT intervention components included: (a) individual self-help materials (e.g., risk checklists, pledge cards); (b) YMCA-facilitated weekly group Diabetes Prevention Program (DPP) weight loss classes; (c) church service activities (e.g., sermons, responsive readings); and (d) church-community text/voice messages to promote healthy eating and physical activity. Health screenings (e.g., weight, blood pressure, blood glucose) were held during church services to identify participants with diabetes/CVD risks and refer them to their church's DPP class and linkage to care services. Participants (N = 352 church members and community members using churches' outreach ministries) were primarily female (67%) and overweight/obese (87%). Overall, FIT intervention participants were significantly more likely to achieve a > 5 lb weight loss (OR = 1.6; CI = 1.24, 2.01) than controls. Odds of intervention FIT-DPP participants achieving a > 5 lb weight loss were 3.6 times more than controls (p < .07). Exposure to sermons, text/email messages, brochures, commitment cards, and posters was significantly related to > 5 lb. weight loss. AA churches can feasibly assist in increasing reach and impact of diabetes/CVD risk reduction interventions with intensive weight loss components among at risk AA church-populations.",2020,lb weight loss were 3.6 times more than controls (p < .07).,"['African American Churches', ""Participants (N\xa0=\u2009352 church members and community members using churches' outreach ministries) were primarily female (67%) and overweight/obese (87"", 'AA church-populations at 8\xa0months', ""participants with diabetes/CVD risks and refer them to their church's DPP class and linkage to care services"", 'Six churches']","['YMCA-facilitated weekly group Diabetes Prevention Program (DPP) weight loss classes', 'multilevel FIT intervention or standard education control arms', 'CVD Risk Reduction Intervention', 'Key multilevel religiously tailored FIT intervention components included: (a) individual self-help materials (e.g., risk checklists, pledge cards']","['Health screenings (e.g., weight, blood pressure, blood glucose', 'weight loss', 'likely to achieve a\xa0', 'lb weight loss']","[{'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0562324', 'cui_str': 'Church'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C3714584', 'cui_str': 'Transformation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}]","[{'cui': 'C0220908', 'cui_str': 'Screening procedure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis'}]",6.0,0.0117529,lb weight loss were 3.6 times more than controls (p < .07).,"[{'ForeName': 'Jannette', 'Initials': 'J', 'LastName': 'Berkley-Patton', 'Affiliation': 'Department of Biomedical and Health Informatics, School of Medicine, and Psychology Department, University of Missouri-Kansas City, 2411 Holmes Street, Kansas City, MO, 64108, USA. berkleypattonj@umkc.edu.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Bowe Thompson', 'Affiliation': 'Department of Biomedical and Health Informatics, School of Medicine, University of Missouri-Kansas City, Kansas City, MO, USA.'}, {'ForeName': 'Alexandria G', 'Initials': 'AG', 'LastName': 'Bauer', 'Affiliation': 'Department of Biomedical and Health Informatics, School of Medicine, and Psychology Department, University of Missouri-Kansas City, 2411 Holmes Street, Kansas City, MO, 64108, USA.'}, {'ForeName': 'Marcie', 'Initials': 'M', 'LastName': 'Berman', 'Affiliation': 'The Institute for Community Research, Hartford, CT, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Bradley-Ewing', 'Affiliation': ""Health Services and Outcomes Research, Children's Mercy Kansas City, Kansas City, MO, USA.""}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Goggin', 'Affiliation': ""Health Services and Outcomes Research, Children's Mercy Kansas City; Schools of Medicine and Pharmacy, University of Missouri-Kansas City, Kansas City, MO, USA.""}, {'ForeName': 'Delwyn', 'Initials': 'D', 'LastName': 'Catley', 'Affiliation': ""Center for Children's Healthy Lifestyles & Nutrition, Children's Mercy Kansas City; Pediatrics, School of Medicine, University of Missouri-Kansas City, Kansas City, MO, USA.""}, {'ForeName': 'Jenifer E', 'Initials': 'JE', 'LastName': 'Allsworth', 'Affiliation': 'Department of Biomedical and Health Informatics, School of Medicine, University of Missouri-Kansas City, Kansas City, MO, USA.'}]",Journal of racial and ethnic health disparities,['10.1007/s40615-020-00740-8']
139,32324238,Azithromycin Treatment vs Placebo in Children With Respiratory Syncytial Virus-Induced Respiratory Failure: A Phase 2 Randomized Clinical Trial.,"Importance


Despite a high disease burden, there is no effective treatment for respiratory syncytial virus (RSV) infection.
Objectives


To determine whether administration of azithromycin (AZM) to children with RSV-induced respiratory failure is safe and to define the effect of AZM therapy on nasal matrix metalloproteinase 9 (MMP-9) levels.
Design, Setting, and Participants


This randomized, double-blind, placebo-controlled phase 2 trial was conducted at a single tertiary pediatric intensive care unit from February 2016 to February 2019. The study included children with RSV infection who were admitted to the pediatric intensive care unit and required respiratory support via positive pressure ventilation (invasive and noninvasive). A total of 147 children were screened; 90 were excluded for not meeting inclusion criteria, having an absent legal guardian, lacking pharmacy support, or having a language barrier and 9 declined participation, resulting in 48 patients enrolled in the study.
Intervention


Receipt of standard dose AZM (10 mg/kg/d), high-dose AZM (20 mg/kg/d), or a matching placebo of normal saline intravenously for 3 days.
Main Outcomes and Measures


Nasal and endotracheal samples were collected at baseline as well as at 24 hours and 48 hours after start of treatment. The secondary outcome was to determine treatment effect on clinical outcome measures, including days of positive pressure ventilation and length of hospital stay.
Results


A total of 48 patients were enrolled in the trial, with a median (range) age at randomization of 12 (1 to 125) months; 36 participants (75.0%) were younger than 2 years. Overall, 26 participants (54.2%) were boys, and 29 (60.4%) had a comorbidity. A total of 16 patients were randomized into each trial group (ie, placebo, standard-dose AZM, and high-dose AZM). Baseline demographic characteristics were comparable among the 3 groups. Both doses of AZM were safe, with no adverse events observed. No difference in nasal MMP-9 levels were observed between treatment groups. Among those who required mechanical ventilation and received high-dose AZM, endotracheal active and total MMP-9 levels were lower on day 3. Compared with baseline, active and total MMP-9 levels in endotracheal aspirates were 1.0 log lower in the high-dose AZM group (active MMP-9: 99.8% CI, -1.28 to -0.64; P < .001; total MMP-9: 99.8% CI, -1.37 to -0.57; P < .001). Patients who received high-dose AZM had fewer median (interquartile range) hospital days compared with those receiving the placebo (8 [6-14] days vs 11 [8-20] days; mean ratio estimate, 0.57; 95% CI, 0.38-0.87; P = .01).
Conclusions and Relevance


In this phase 2 randomized clinical trial, both doses of AZM were safe. While nasal MMP-9 levels were unchanged among treatment groups, endotracheal MMP-9 levels were lower among those who received high-dose AZM. The positive secondary clinical outcome, while exploratory, provides insight for end points in a multicenter randomized trial.
Trial Registration


ClinicalTrials.gov Identifier: NCT02707523.",2020,"While nasal MMP-9 levels were unchanged among treatment groups, endotracheal MMP-9 levels were lower among those who received high-dose AZM.","['single tertiary pediatric intensive care unit from February 2016 to February 2019', 'children with RSV-induced respiratory failure', 'children with RSV infection who were admitted to the pediatric intensive care unit and required respiratory support via positive pressure ventilation (invasive and noninvasive', '16 patients', 'A total of 147 children were screened; 90 were excluded for not meeting inclusion criteria, having an absent legal guardian, lacking pharmacy support, or having a language barrier and 9 declined participation, resulting in 48 patients enrolled in the study', 'Children With Respiratory Syncytial Virus-Induced Respiratory Failure', '48 patients were enrolled in the trial, with a median (range) age at randomization of 12 (1 to 125) months; 36 participants (75.0%) were younger than 2 years', '26 participants (54.2%) were boys, and 29 (60.4%) had a comorbidity']","['placebo of normal saline intravenously for 3 days', 'AZM therapy', 'azithromycin (AZM', 'standard dose AZM', 'placebo, standard-dose AZM, and high-dose AZM', 'high-dose AZM', 'placebo', 'Azithromycin Treatment vs Placebo', 'AZM']","['endotracheal MMP-9 levels', 'active and total MMP-9 levels', 'days of positive pressure ventilation and length of hospital stay', 'Measures\n\n\nNasal and endotracheal samples', 'endotracheal active and total MMP-9 levels', 'Baseline demographic characteristics', 'nasal MMP-9 levels']","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0021710', 'cui_str': 'Pediatric intensive care unit'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0035236', 'cui_str': 'Syncytial Virus, Respiratory'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C0035235', 'cui_str': 'Respiratory syncytial virus infection'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0021778', 'cui_str': 'Intermittent positive pressure ventilation'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0023226', 'cui_str': 'Legal guardian'}, {'cui': 'C0332268', 'cui_str': 'Lacking'}, {'cui': 'C0031321', 'cui_str': 'Pharmacy service'}, {'cui': 'C0237167', 'cui_str': 'Language barrier'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517808', 'cui_str': '54.2'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C1522653', 'cui_str': 'Intratracheal route'}, {'cui': 'C0165519', 'cui_str': 'Gelatinase B'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021778', 'cui_str': 'Intermittent positive pressure ventilation'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}]",147.0,0.764452,"While nasal MMP-9 levels were unchanged among treatment groups, endotracheal MMP-9 levels were lower among those who received high-dose AZM.","[{'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Kong', 'Affiliation': 'Department of Pediatrics, University of Alabama at Birmingham.'}, {'ForeName': 'Wei Wei', 'Initials': 'WW', 'LastName': 'Zhang', 'Affiliation': 'Department of Pediatrics, University of Alabama at Birmingham.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Sewell', 'Affiliation': 'Department of Pediatrics, University of Alabama at Birmingham.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Gorman', 'Affiliation': 'McWhorter School of Pharmacy, Samford University, Birmingham, Alabama.'}, {'ForeName': 'Hui-Chien', 'Initials': 'HC', 'LastName': 'Kuo', 'Affiliation': 'Department of Pediatrics, University of Alabama at Birmingham.'}, {'ForeName': 'Inmaculada', 'Initials': 'I', 'LastName': 'Aban', 'Affiliation': 'Department of Pediatrics, University of Alabama at Birmingham.'}, {'ForeName': 'Namasivayam', 'Initials': 'N', 'LastName': 'Ambalavanan', 'Affiliation': 'Department of Pediatrics, University of Alabama at Birmingham.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Whitley', 'Affiliation': 'Department of Pediatrics, University of Alabama at Birmingham.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.3482']
140,31393029,Motivational Interviewing to Address Suicidal Ideation: A Randomized Controlled Trial in Veterans.,"OBJECTIVE


Although the months following discharge from psychiatric hospitalization are a period of acute risk for veterans, there is a dearth of empirically supported treatments tailored to veterans in acute psychiatric hospitalization.
METHOD


We conducted a randomized controlled trial to test the efficacy of Motivational Interviewing to Address Suicidal Ideation (MI-SI) that explored and resolved ambivalence, and a revised MI-SI (MI-SI-R) that resolved ambivalence, on suicidal ideation (SI) in hospitalized veterans who scored > 2 on the Scale for Suicidal Ideation. Participants were randomized to receive MI-SI plus treatment as usual (TAU), MI-SI-R+TAU, or TAU alone. MI-SI+TAU and MI-SI-R+TAU included two in-hospital therapy sessions and one telephone booster session. Participants completed follow-up assessments over 6 months.
RESULTS


Participants in all groups experienced reductions in the presence and severity of SI, but there were no significant differences among the groups. For the presence of SI, results were in the hypothesized direction for both MI-SI+TAU conditions.
CONCLUSIONS


Results are nondefinitive, but the effect size of both versions of MI-SI+TAU on the presence of SI was consistent with prior MI findings. Exploratory analyses suggest MI-SI-R may be preferable to MI-SI. More intensive MI-SI-R with a greater number of follow-ups may increase its effectiveness.",2020,"We conducted a randomized controlled trial to test the efficacy of Motivational Interviewing to Address Suicidal Ideation (MI-SI) that explored and resolved ambivalence, and a revised MI-SI (MI-SI-R) that resolved ambivalence, on suicidal ideation (SI) in hospitalized veterans who scored > 2 on the Scale for Suicidal Ideation.","['hospitalized veterans who scored\xa0>\xa02 on the Scale for Suicidal Ideation', 'Veterans']","['Motivational Interviewing to Address', 'Motivational Interviewing', 'MI-SI plus treatment as usual (TAU), MI-SI-R+TAU, or TAU alone']","['Suicidal Ideation (MI-SI', 'suicidal ideation (SI', 'presence and severity of SI', 'Suicidal Ideation']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0424000', 'cui_str': 'Suicidal Ideation'}]","[{'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0376649', 'cui_str': 'Address'}, {'cui': 'C0683474', 'cui_str': 'Motivational Interviewing'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1720655', 'cui_str': 'Tau'}]","[{'cui': 'C0424000', 'cui_str': 'Suicidal Ideation'}, {'cui': 'C3854307', 'cui_str': 'Presence'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",,0.0407306,"We conducted a randomized controlled trial to test the efficacy of Motivational Interviewing to Address Suicidal Ideation (MI-SI) that explored and resolved ambivalence, and a revised MI-SI (MI-SI-R) that resolved ambivalence, on suicidal ideation (SI) in hospitalized veterans who scored > 2 on the Scale for Suicidal Ideation.","[{'ForeName': 'Peter C', 'Initials': 'PC', 'LastName': 'Britton', 'Affiliation': 'VISN 2 Center of Excellence for Suicide Prevention, Department of Veterans Affairs, Canandaigua Medical Center, Canandaigua, NY, USA.'}, {'ForeName': 'Kenneth R', 'Initials': 'KR', 'LastName': 'Conner', 'Affiliation': 'VISN 2 Center of Excellence for Suicide Prevention, Department of Veterans Affairs, Canandaigua Medical Center, Canandaigua, NY, USA.'}, {'ForeName': 'Benjamin P', 'Initials': 'BP', 'LastName': 'Chapman', 'Affiliation': 'Department of Psychiatry, University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Maisto', 'Affiliation': 'Center for Integrated Healthcare, Department of Veterans Affairs, Syracuse Medical Center, Syracuse, NY, USA.'}]",Suicide & life-threatening behavior,['10.1111/sltb.12581']
141,31400515,"A randomized pragmatic trial of telephone-delivered cognitive behavioral-therapy, modafinil, and combination therapy of both for fatigue in multiple sclerosis: The design of the ""COMBO-MS"" trial.","BACKGROUND


Fatigue is one of the most common and disabling chronic symptoms in multiple sclerosis (MS). Optimization of available treatments for MS-related fatigue has been stymied by lack of comparative effectiveness research that focuses on real-world treatment delivery methods and potential modification of treatment effect by other chronic MS symptoms or disability level. This report describes the design of a patient centered, comparative effectiveness trial of cognitive behavioral-therapy (CBT), modafinil, and combination therapy of both for fatigue in MS (""COMBO-MS"").
METHODS


We describe the methods of this pragmatic comparative effectiveness trial that is guided by a team of patient, family, provider, community, and payer stakeholders. Eligible participants with MS and significant fatigue severity are randomly assigned (1:1:1) to received either CBT, modafinil, or a combination of CBT and modafinil for 12 weeks. The primary outcome is change in fatigue impact as measured by the Modified Fatigue Impact Scale (MFIS) at 12 weeks. Secondary outcome measures include ecological momentary assessment (EMA) measures of fatigue intensity, fatigue interference, and fatigability (measured over 7 days' time at baseline and at 12 weeks), and change in MFIS score at 24 weeks.
PROJECTED OUTCOMES


We hypothesize that combination therapy will more effectively ameliorate fatigue severity than either monotherapy, and that heterogeneity of treatment effects will be found based on depression status, presence of known or suspected sleep disorder, and disease severity. Study findings will assist patients, providers, payers, and policy makers to provide more effective care for managing fatigue in MS.",2019,The primary outcome is change in fatigue impact as measured by the Modified Fatigue Impact Scale (MFIS) at 12 weeks.,"['multiple sclerosis', 'Eligible participants with MS and significant fatigue severity']","['CBT, modafinil, or a combination of CBT and modafinil', 'telephone-delivered cognitive behavioral-therapy, modafinil, and combination therapy', 'cognitive behavioral-therapy (CBT), modafinil, and combination therapy']","['change in fatigue impact as measured by the Modified Fatigue Impact Scale (MFIS', ""ecological momentary assessment (EMA) measures of fatigue intensity, fatigue interference, and fatigability (measured over 7\u202fdays' time at baseline and at 12\u202fweeks), and change in MFIS score""]","[{'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]","[{'cui': 'C0066677', 'cui_str': 'modafinil'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C2733557', 'cui_str': 'Fatigue impact scale (assessment scale)'}, {'cui': 'C4277684', 'cui_str': 'Ecological Momentary Assessment'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0231230', 'cui_str': 'Fatigability (finding)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.101421,The primary outcome is change in fatigue impact as measured by the Modified Fatigue Impact Scale (MFIS) at 12 weeks.,"[{'ForeName': 'Anna L', 'Initials': 'AL', 'LastName': 'Kratz', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Michigan Medicine, University of Michigan, Ann Arbor, MI, USA. Electronic address: alkratz@med.umich.edu.'}, {'ForeName': 'Kevin N', 'Initials': 'KN', 'LastName': 'Alschuler', 'Affiliation': 'Department of Rehabilitation Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Dawn M', 'Initials': 'DM', 'LastName': 'Ehde', 'Affiliation': 'Department of Rehabilitation Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Gloria', 'Initials': 'G', 'LastName': 'von Geldern', 'Affiliation': 'Department of Rehabilitation Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Roderick', 'Initials': 'R', 'LastName': 'Little', 'Affiliation': 'Department of Biostatistics, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Shubhangi', 'Initials': 'S', 'LastName': 'Kulkarni', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Michigan Medicine, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Pickup', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Michigan Medicine, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Tiffany J', 'Initials': 'TJ', 'LastName': 'Braley', 'Affiliation': 'Department of Neurology, Michigan Medicine, University of Michigan, Ann Arbor, MI, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105821']
142,31400516,Design of the PACIFIC study: A randomized controlled trial evaluating a novel treatment for adults with overweight and obesity.,"The majority of adults in the United States have overweight or obesity which is associated with significant health and psychological consequences. Behavioral Weight Loss (BWL) is the current gold-standard weight-loss program for adults but recidivism rates continue to be disturbingly high. Given the health consequences of excess weight and the lack of long-term effectiveness of BWL, it is important to identify novel weight-loss programs. We developed the ROC (Regulation of Cues) program to reduce overeating through improvement in sensitivity to appetitive cues and decreased responsivity to external food cues. This study is a 4-arm randomized control trial designed to evaluate the efficacy of ROC, ROC combined with BWL, BWL alone and an active comparator over 24 months. Study recruitment completed in November 2017. Two hundred and seventy-one participants were randomized (mean age = 46.97 years; 82% female, mean BMI = 34.59; 20% Hispanic) and assessments were conducted at baseline, mid-treatment (6 months) and post-treatment (12 months). At this time, participants are completing 6- (18 months) and 12-month (24 months) follow-ups. Targeting novel mechanisms is critically important to improve weight-loss programs. Through this trial, we hope to identify treatments for adults with overweight and obesity to facilitate long-term weight loss and improved health.",2019,We developed the ROC (Regulation of Cues) program to reduce overeating through improvement in sensitivity to appetitive cues and decreased responsivity to external food cues.,"['adults with overweight and obesity', 'Two hundred and seventy-one participants were randomized (mean age\u202f=\u202f46.97\u202fyears; 82% female, mean BMI\u202f=\u202f34.59; 20% Hispanic', 'adults with overweight and obesity to facilitate long-term weight loss and improved health']","['ROC, ROC combined with BWL, BWL alone']",['Behavioral Weight Loss (BWL'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C4319603', 'cui_str': '270 (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]",271.0,0.0641581,We developed the ROC (Regulation of Cues) program to reduce overeating through improvement in sensitivity to appetitive cues and decreased responsivity to external food cues.,"[{'ForeName': 'Kerri N', 'Initials': 'KN', 'LastName': 'Boutelle', 'Affiliation': 'Department of Pediatrics, University of California San Diego, 9500 Gilman Drive, La Jolla, CA 92037, USA; Department of Family Medicine and Public Health, University of California San Diego, 9500 Gilman Drive, La Jolla, CA 92037, USA; Department of Psychiatry, University of California San Diego, 9500 Gilman Drive, La Jolla, CA 92037, USA. Electronic address: kboutelle@ucsd.edu.'}, {'ForeName': 'Dawn M', 'Initials': 'DM', 'LastName': 'Eichen', 'Affiliation': 'Department of Pediatrics, University of California San Diego, 9500 Gilman Drive, La Jolla, CA 92037, USA.'}, {'ForeName': 'Carol B', 'Initials': 'CB', 'LastName': 'Peterson', 'Affiliation': 'Department of Psychiatry, University of Minnesota, F282/2A West 2450, Riverside Ave, Minneapolis, MN 55454, USA.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Strong', 'Affiliation': 'Department of Family Medicine and Public Health, University of California San Diego, 9500 Gilman Drive, La Jolla, CA 92037, USA.'}, {'ForeName': 'Cheryl L', 'Initials': 'CL', 'LastName': 'Rock', 'Affiliation': 'Department of Psychiatry, University of California San Diego, 9500 Gilman Drive, La Jolla, CA 92037, USA.'}, {'ForeName': 'Bess H', 'Initials': 'BH', 'LastName': 'Marcus', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University, School of Public Health, 121 South Main Street, Box G-S121-3, Providence, RI 02912-G, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105824']
143,31982416,Computer-assisted motivational interviewing for contraceptive use in women leaving prison: A randomized controlled trial.,"OBJECTIVES


Rates of unintended pregnancies in women with a history of incarceration are high and access to contraception before and after arrest can be limited. Individualized counseling can better prepare women for healthy pregnancy or provide an opportunity for contraceptive education and access within correctional facilities. In this study, we assessed the efficacy of motivational interviewing as an individualized intervention to increase the initiation of contraceptive methods while incarcerated and continuation after release in female inmates who wanted to avoid pregnancy for at least one year after release.
STUDY DESIGN


We performed an RCT in a population of incarcerated women who wanted to avoid pregnancy. Women were randomized to either a computer-assisted motivational interviewing intervention group (n = 119) or an educational video with counseling control group. (n = 113). The primary outcome was initiation of a method of birth control prior to release from the correctional facility.
RESULTS


Initiation of contraception was higher in the intervention group (56% vs. 42%, p = 0.03), but this difference was not significant after controlling for number of male partners within the year prior to incarceration. There was no difference between the groups in the rates of pregnancies or STIs or continuation of contraception after release, which was generally low (21%).
CONCLUSION


Computer-assisted motivational interviewing did not improve uptake or continuation of contraception in this study.
IMPLICATIONS


Periods of incarceration provide an opportunity to offer contraceptive services to women who want to avoid a pregnancy. Motivational interviewing may not be an effective method to affect contraceptive behaviors in this population. Future research should explore the family planning values and preferences of women who become involved with the correctional system.",2020,"RESULTS


Initiation of contraception was higher in the intervention group (56% vs. 42%, p=0.03), but this difference was not significant after controlling for number of male partners within the year prior to incarceration.","['women with a history of incarceration', 'Women', 'Leaving Prison', 'female inmates who wanted to avoid pregnancy for at least one year after release', 'population of incarcerated women who wanted to avoid pregnancy']","['Computer-assisted motivational interviewing', 'computer-assisted motivational interviewing intervention group (n=119) or an educational video with counseling control group', 'motivational interviewing', 'Individualized counseling', 'Computer-Assisted Motivational Interviewing']","['uptake or continuation of contraception', 'rates of pregnancies or STIs or continuation of contraception', 'Initiation of contraception', 'initiation of a method of birth control prior to release from the correctional facility']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205255', 'cui_str': 'Imprisonment (finding)'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0033168', 'cui_str': 'Prisons'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C1444647', 'cui_str': 'Wanted'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0392751', 'cui_str': 'Incarcerated (qualifier value)'}]","[{'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0683474', 'cui_str': 'Motivational Interviewing'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0341618', 'cui_str': 'Counsel (occupation)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0700589', 'cui_str': 'Fertility Control'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0036916', 'cui_str': 'STDs'}, {'cui': 'C3838863', 'cui_str': 'Initiation of contraception (regime/therapy)'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0442681', 'cui_str': 'Penal institution (environment)'}]",,0.137903,"RESULTS


Initiation of contraception was higher in the intervention group (56% vs. 42%, p=0.03), but this difference was not significant after controlling for number of male partners within the year prior to incarceration.","[{'ForeName': 'E C', 'Initials': 'EC', 'LastName': 'Brousseau', 'Affiliation': 'Warren Alpert Medical School of Brown University, Women & Infants Hospital, 101 Dudley Street, Providence, RI 02905, USA. Electronic address: ebrousseau@wihri.org.'}, {'ForeName': 'J G', 'Initials': 'JG', 'LastName': 'Clarke', 'Affiliation': 'Warren Alpert Medical School of Brown University, Women & Infants Hospital, 101 Dudley Street, Providence, RI 02905, USA; Rhode Island Department of Corrections, Medical Program Director, 39 Howard Avenue, Cranston, RI 02920, USA. Electronic address: Jennifer_clarke@doc.ri.gov.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Dumont', 'Affiliation': 'Rhode Island Department of Health, Division of Community Health & Equity, 3 Capitol Hill, Providence, RI, 02908, USA. Electronic address: dora.dumont@health.ri.gov.'}, {'ForeName': 'L A R', 'Initials': 'LAR', 'LastName': 'Stein', 'Affiliation': 'University of Rhode Island, Department of Psychology, 306 Chafee Hall, 142 Flagg Road, Kingston, RI 02881, USA. Electronic address: LARStein@uri.edu.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Roberts', 'Affiliation': 'Brown University Center for Primary Care & Prevention, Memorial Hospital of Rhode Island, USA. Electronic address: MRoberts@carene.org.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'van den Berg', 'Affiliation': 'School of Public Health, Brown University, Center for Alcohol & Addiction Studies, Department of Behavioral & Social Sciences, 121 South Main Street, Providence, RI 02912, USA. Electronic address: Jacob_vandenberg@brown.edu.'}]",Contraception,['10.1016/j.contraception.2020.01.004']
144,32322692,Postal recruitment for genetic studies of preterm birth: A feasibility study.,"Background:  Preterm birth (PTB) represents the leading cause of neonatal death. Large-scale genetic studies are necessary to determine genetic influences on PTB risk, but prospective cohort studies are expensive and time-consuming. We investigated the feasibility of retrospective recruitment of post-partum women for efficient collection of genetic samples, with self-collected saliva for DNA extraction from themselves and their babies, alongside self-recollection of pregnancy and birth details to phenotype PTB.  Methods:  708 women who had participated in the OPPTIMUM trial (a randomised trial of progesterone pessaries to prevent PTB [ISRCTN14568373]) and consented to further contact were invited to provide self-collected saliva from themselves and their babies. DNA was extracted from Oragene OG-500 (adults) and OG-575 (babies) saliva kits and the yield measured by Qubit. Samples were analysed using a panel of Taqman single nucleotide polymorphism (SNP) assays. A questionnaire designed to meet the minimum data set required for phenotyping PTB was included. Questionnaire responses were transcribed and analysed for concordance with prospective trial data using Cohen's kappa (  k ).  Results:  Recruitment rate was 162/708 (23%) for self-collected saliva samples and 157/708 (22%) for questionnaire responses. 161 samples from the mother provided DNA with median yield 59.0µg (0.4-148.9µg). 156 samples were successfully genotyped (96.9%). 136 baby samples had a median yield 11.5µg (0.1-102.7µg); two samples failed DNA extraction. 131 baby samples (96.3%) were successfully genotyped. Concordance between self-recalled birth details and prospective birth details was excellent (  k >0.75) in 4 out of 10 key fields for phenotyping PTB (mode of delivery, labour onset, ethnicity and maternal age at birth).  Conclusion:  This feasibility study demonstrates that self-collected DNA samples from mothers and babies were sufficient for genetic analysis but yields were variable. Self-recollection of pregnancy and birth details was inadequate for accurately phenotyping PTB, highlighting the need for alternative strategies for investigating genetic links with PTB.",2020,"The highest rates of concordance were found for mode of birth (154/156 [99%]), smoking status (151/157 [96%]) and ethnicity (149/156 [96%]).  ","['708 women who had participated in the OPPTIMUM trial', '136 baby samples had a median yield 11.5µg (0.1-102.7µg); two samples failed DNA extraction', 'preterm birth', '131 baby samples (96.3%) were successfully genotyped']",['progesterone pessaries'],"['Questionnaire responses', 'smoking status', 'Recruitment rate']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C4517534', 'cui_str': '11.5'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C3839098', 'cui_str': 'Deoxyribonucleic acid extraction technique'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}]","[{'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0031246', 'cui_str': 'Pessary'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}]",708.0,0.0435535,"The highest rates of concordance were found for mode of birth (154/156 [99%]), smoking status (151/157 [96%]) and ethnicity (149/156 [96%]).  ","[{'ForeName': 'Oonagh E', 'Initials': 'OE', 'LastName': 'Keag', 'Affiliation': 'Simpson Centre for Reproductive Health, Royal Infirmary of Edinburgh, Edinburgh, EH16 4SA, UK.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Murphy', 'Affiliation': 'Edinburgh Clinical Research Facility, Western General Hospital, Edinburgh, EH4 2XU, UK.'}, {'ForeName': 'Aoibheann', 'Initials': 'A', 'LastName': 'Bradley', 'Affiliation': 'Queen Margaret Hospital, Dunfermline, KY12 0SU, UK.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Deakin', 'Affiliation': 'Department of Clinical Neurosciences, University of Cambridge, Cambridge, CB2 0QQ, UK.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Whyte', 'Affiliation': 'MRC Centre for Reproductive Health, University of Edinburgh, Edinburgh, EH16 4TJ, UK.'}, {'ForeName': 'Jane E', 'Initials': 'JE', 'LastName': 'Norman', 'Affiliation': 'Faculty of Health Sciences, University of Bristol, Bristol, BS8 1UD, UK.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Stock', 'Affiliation': 'Simpson Centre for Reproductive Health, Royal Infirmary of Edinburgh, Edinburgh, EH16 4SA, UK.'}]",Wellcome open research,['10.12688/wellcomeopenres.15207.2']
145,31586170,Comment on: A trial of a mechanical device for the treatment of blepharospasm.,,2020,,[],['mechanical device'],[],[],"[{'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0220819', 'cui_str': 'devices'}]",[],,0.0269564,,"[{'ForeName': 'Jonathan A', 'Initials': 'JA', 'LastName': 'Go', 'Affiliation': 'Baylor College of Medicine, 1 Baylor Plaza, Houston, TX, 77030, USA.'}, {'ForeName': 'Ashley N', 'Initials': 'AN', 'LastName': 'Anderson', 'Affiliation': 'Baylor College of Medicine, 1 Baylor Plaza, Houston, TX, 77030, USA.'}, {'ForeName': 'Ashwini', 'Initials': 'A', 'LastName': 'Kini', 'Affiliation': 'Department of Ophthalmology, Blanton Eye Institute, Houston Methodist Hospital, 6550 Fannin St, Houston, TX, 77030, USA.'}, {'ForeName': 'Bayan', 'Initials': 'B', 'LastName': 'Al Othman', 'Affiliation': 'Department of Ophthalmology, Blanton Eye Institute, Houston Methodist Hospital, 6550 Fannin St, Houston, TX, 77030, USA.'}, {'ForeName': 'Andrew G', 'Initials': 'AG', 'LastName': 'Lee', 'Affiliation': 'Baylor College of Medicine, 1 Baylor Plaza, Houston, TX, 77030, USA. aglee@houstonmethodist.org.'}]","Eye (London, England)",['10.1038/s41433-019-0621-x']
146,31434935,Randomized clinical trial: the effect of probiotic Bacillus coagulans Unique IS2 vs. placebo on the symptoms management of irritable bowel syndrome in adults.,"The therapeutic effects of B. coagulans Unique IS2 have been well established in children with irritable bowel syndrome (IBS), but its efficacy in adults remain under reported. Thus, in this study the efficacy of B. coagulans Unique IS2 in the management of IBS symptoms in adults was investigated. Patients (n = 153) fulfilling Rome III criteria were provided placebo capsules for a 2 weeks run-in period. Only patients satisfying compliance criteria (n = 136) were randomized (double blind) to receive either B. coagulans Unique IS2 (2 billion CFU) or placebo capsules daily for 8 weeks. Reduction of abdominal discomfort/pain intensity and increase in complete spontaneous bowel movements were analyzed as primary end points. Other clinical symptoms of IBS and serum cytokines were also evaluated. B. coagulans Unique IS2 showed significant improvement in primary and secondary endpoints, as compared to placebo. Haematology of both the arms remained normal. No significant changes in pro- (IL-6, IL-12, TNF-α, INF- γ) and anti-inflammatory cytokine (IL-10) levels were detected at the end of B. coagulans treatment (8 weeks) as compared to placebo. B. coagulans was well tolerated with no severe adverse events to report. Overall, the results demonstrate that B. coagulans Unique IS2 is efficacious in the management of IBS symptoms in adults (18-60 years).",2019,"No significant changes in pro- (IL-6, IL-12, TNF-α, INF- γ) and anti-inflammatory cytokine (IL-10) levels were detected at the end of B. coagulans treatment (8 weeks) as compared to placebo.","['irritable bowel syndrome in adults', 'children with irritable bowel syndrome (IBS', 'Only patients satisfying compliance criteria (n\u2009=\u2009136', 'Patients (n\u2009', '153) fulfilling Rome III criteria were provided']","['B. coagulans Unique IS2 (2 billion CFU) or placebo', 'placebo', 'probiotic Bacillus coagulans Unique IS2 vs. placebo']","['complete spontaneous bowel movements', 'Reduction of abdominal discomfort/pain intensity', 'IBS and serum cytokines', 'pro- (IL-6, IL-12, TNF-α, INF- γ) and anti-inflammatory cytokine (IL-10) levels']","[{'cui': 'C0022104', 'cui_str': 'Irritable Bowel Syndrome'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C4517568', 'cui_str': 'One hundred and thirty-six'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0004587', 'cui_str': 'Bacillus'}]","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0232487', 'cui_str': 'Abdominal discomfort (finding)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0123759', 'cui_str': 'Interleukin-12'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.29664,"No significant changes in pro- (IL-6, IL-12, TNF-α, INF- γ) and anti-inflammatory cytokine (IL-10) levels were detected at the end of B. coagulans treatment (8 weeks) as compared to placebo.","[{'ForeName': 'Ratna Sudha', 'Initials': 'RS', 'LastName': 'Madempudi', 'Affiliation': 'Centre for Research & Development, Unique Biotech Ltd., Plot No. 2, Phase-II, Alexandria Knowledge Park, Hyderabad, Telangana, 500078, India. sudha@uniquebiotech.com.'}, {'ForeName': 'Jayesh J', 'Initials': 'JJ', 'LastName': 'Ahire', 'Affiliation': 'Centre for Research & Development, Unique Biotech Ltd., Plot No. 2, Phase-II, Alexandria Knowledge Park, Hyderabad, Telangana, 500078, India.'}, {'ForeName': 'Jayanthi', 'Initials': 'J', 'LastName': 'Neelamraju', 'Affiliation': 'Centre for Research & Development, Unique Biotech Ltd., Plot No. 2, Phase-II, Alexandria Knowledge Park, Hyderabad, Telangana, 500078, India.'}, {'ForeName': 'Anirudh', 'Initials': 'A', 'LastName': 'Tripathi', 'Affiliation': 'Life Veda Treatment and Research Centre, Worli, Mumbai, 400030, India.'}, {'ForeName': 'Satyavrat', 'Initials': 'S', 'LastName': 'Nanal', 'Affiliation': 'Nanal Clinic, Anand Bhuvan, Gore wadi, Mahim (W), Mumbai, 400016, India.'}]",Scientific reports,['10.1038/s41598-019-48554-x']
147,31592825,"Repeated Full-Face Aesthetic Combination Treatment With AbobotulinumtoxinA, Hyaluronic Acid Filler, and Skin-Boosting Hyaluronic Acid After Monotherapy With AbobotulinumtoxinA or Hyaluronic Acid Filler.","BACKGROUND


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


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


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


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


Repeated combination treatment achieved greater change in global facial aesthetic appearance than monotherapy. Aesthetic improvement and subject satisfaction was high and increased with each treatment. All treatments were well tolerated.",2020,Aesthetic improvement and subject satisfaction was high and increased with each treatment.,['Subjects aged 35 to 50 years'],"['monotherapy with either abobotulinumtoxinA (ABO) or hyaluronic acid (HA) filler', 'AbobotulinumtoxinA, Hyaluronic Acid Filler, and Skin-Boosting Hyaluronic Acid', 'monotherapy', 'AbobotulinumtoxinA or Hyaluronic Acid Filler']","['tolerated', 'facial aesthetic outcome', 'global facial aesthetic appearance', 'ABO, HA filler, and skin-boosting HA (RSB', 'Improvement rate of glabellar lines', 'Aesthetic improvement and subject satisfaction', 'global facial aesthetic appearance and improvement, first impression, perceived age, wrinkle severity, satisfaction questionnaires, and adverse events', 'aesthetic improvement and subject satisfaction']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C2719424', 'cui_str': 'abobotulinumtoxinA'}, {'cui': 'C1141990', 'cui_str': 'Hyaluronic acid'}, {'cui': 'C0729441', 'cui_str': 'Filler (substance)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}]","[{'cui': 'C0014901', 'cui_str': 'Esthetics'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0700364', 'cui_str': 'Appearances (qualifier value)'}, {'cui': 'C0729441', 'cui_str': 'Filler (substance)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0442019', 'cui_str': 'Glabellar (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0037301', 'cui_str': 'Skin Wrinkling'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0458485,Aesthetic improvement and subject satisfaction was high and increased with each treatment.,"[{'ForeName': 'Hugues', 'Initials': 'H', 'LastName': 'Cartier', 'Affiliation': 'Centre Medical Saint-Jean, Arras, France.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Hedén', 'Affiliation': 'Akademikliniken, Stockholm, Sweden.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Delmar', 'Affiliation': 'Mediti-Clinique Science et Beauté, Juan-les-Pins, France.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Bergentz', 'Affiliation': 'Akademikliniken, Stockholm, Sweden.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Skoglund', 'Affiliation': 'Galderma Aesthetics, Medical Affairs, Uppsala, Sweden.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Edwartz', 'Affiliation': 'Galderma Aesthetics, Medical Affairs, Uppsala, Sweden.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Norberg', 'Affiliation': 'Galderma Aesthetics, Medical Affairs, Uppsala, Sweden.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Kestemont', 'Affiliation': 'Mediti-Clinique Science et Beauté, Juan-les-Pins, France.'}]",Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.],['10.1097/DSS.0000000000002165']
148,32327087,Optimal Timing of Intervention in NSTE-ACS Without Pre-Treatment: The EARLY Randomized Trial.,"OBJECTIVES


The aim of this study was to compare a delayed and a very early invasive strategy in patients with non-ST-segment elevation acute coronary syndromes (NSTE-ACS) without pre-treatment.
BACKGROUND


The optimal delay of the invasive strategy in patients with NSTE-ACS remains debated and has never been investigated in patients not pre-treated with P2Y 12 -adenosine diphosphate receptor antagonists.
METHODS


A prospective, open-label, randomized controlled trial was conducted. Altogether, 741 patients presenting with intermediate- or high-risk NSTE-ACS intended for an invasive strategy were included. The modified intention-to-treat analysis was composed of 709 patients after 32 withdrew consent. Patients were randomized 1:1 to the delayed invasive group (DG) (n = 363) with coronary angiography (CA) performed 12 to 72 h after randomization or the very early invasive group (EG) (n = 346) with CA within 2 h. No pre-treatment with a loading dose of a P2Y 12 -adenosine diphosphate receptor antagonist was allowed before CA. The primary endpoint was the composite of cardiovascular death and recurrent ischemic events at 1 month, as determined by a blinded adjudication committee.
RESULTS


Most patients had high-risk NSTE-ACS in both groups (93% in the EG vs. 92.5% in the DG). The median time between randomization and CA was 0 h (interquartile range [IQR]: 0 to 1 h) in the EG group and 18 h (IQR: 11 to 23 h) in the DG. The primary endpoint rate was significantly lower in the EG (4.4% vs. 21.3% in the DG; hazard ratio: 0.20; 95% confidence interval: 0.11 to 0.34; p < 0.001), driven by a reduction in recurrent ischemic events (19.8% vs. 2.9%; p < 0.001). No difference was observed for cardiovascular death.
CONCLUSIONS


Without pre-treatment, a very early invasive strategy was associated with a significant reduction in ischemic events at the time of percutaneous coronary intervention in patients with intermediate- and high-risk NSTE-ACS. (Early or Delayed Revascularization for Intermediate and High-Risk Non ST-Elevation Acute Coronary Syndromes; NCT02750579).",2020,"The primary endpoint rate was significantly lower in the EG (4.4% vs. 21.3% in the DG; hazard ratio: 0.20; 95% confidence interval: 0.11 to 0.34; p < 0.001), driven by a reduction in recurrent ischemic events (19.8% vs. 2.9%; p < 0.001).","['709 patients after 32 withdrew consent', '741 patients presenting with intermediate- or high-risk NSTE-ACS intended for an invasive strategy were included', 'patients with non-ST-segment elevation acute coronary syndromes (NSTE-ACS']",['delayed invasive group (DG) (n\xa0=\xa0363) with coronary angiography (CA) performed 12 to 72\xa0h after randomization or the very early invasive group (EG'],"['ischemic events', 'recurrent ischemic events', 'composite of cardiovascular death and recurrent ischemic events', 'median time', 'cardiovascular death', 'high-risk NSTE-ACS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C3160886', 'cui_str': 'Non ST segment elevation acute coronary syndrome'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1279919', 'cui_str': 'Early'}]","[{'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C3160886', 'cui_str': 'Non ST segment elevation acute coronary syndrome'}]",741.0,0.0563662,"The primary endpoint rate was significantly lower in the EG (4.4% vs. 21.3% in the DG; hazard ratio: 0.20; 95% confidence interval: 0.11 to 0.34; p < 0.001), driven by a reduction in recurrent ischemic events (19.8% vs. 2.9%; p < 0.001).","[{'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Lemesle', 'Affiliation': ""USIC et Centre Hémodynamique, Institut Cœur Poumon, Centre Hospitalier Universitaire de Lille, Lille, France; Faculté de Médecine de l'Université de Lille, Lille, France; INSERM UMR 1011, Institut Pasteur de Lille, Lille, France; French Alliance for Cardiovascular Trials, Paris, France.""}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Laine', 'Affiliation': 'Aix-Marseille Université, Intensive Care Unit, Department of Cardiology, Assistance Publique-Hôpitaux de Marseille, Hôpital Nord, Marseille, France; Mediterranean Association for Research and Studies in Cardiology, Marseille, France; Centre for CardioVascular and Nutrition Research, INSERM 1263, INRA 1260, Marseille, France.'}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Pankert', 'Affiliation': 'Service de Cardiologie, Centre Hospitalier Henri Duffaut, Avignon, France.'}, {'ForeName': 'Ziad', 'Initials': 'Z', 'LastName': 'Boueri', 'Affiliation': 'Service de Cardiologie, Centre Hospitalier de Bastia, Bastia, France.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Motreff', 'Affiliation': 'Département de Cardiologie, Centre Hospitalier Universitaire Gabriel Montpied, Clermont-Ferrand, France.'}, {'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Paganelli', 'Affiliation': 'Aix-Marseille Université, Intensive Care Unit, Department of Cardiology, Assistance Publique-Hôpitaux de Marseille, Hôpital Nord, Marseille, France; Mediterranean Association for Research and Studies in Cardiology, Marseille, France; Centre for CardioVascular and Nutrition Research, INSERM 1263, INRA 1260, Marseille, France.'}, {'ForeName': 'Karine', 'Initials': 'K', 'LastName': 'Baumstarck', 'Affiliation': ""Unité d'Aide Méthodologique à la Recherche Clinique, EA 3279, Laboratoire de Santé Publique, Aix-Marseille Université, Marseille, France.""}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Roch', 'Affiliation': ""Hôpital Nord, Marseille, France; Service d'Accueil des Urgences, Hôpital Nord, Marseille, France.""}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Kerbaul', 'Affiliation': 'Pole RUSH, Assistance-Publique Hôpitaux de Marseille, UMR MD2 - Aix-Marseille Université, Marseille, France.'}, {'ForeName': 'Etienne', 'Initials': 'E', 'LastName': 'Puymirat', 'Affiliation': 'Département de Cardiologie, Hôpital Européen Georges Pompidou, Assistance Publique des Hôpitaux de Paris, Paris, France; Université Paris Descartes, INSERM U-970, Paris, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Bonello', 'Affiliation': 'Aix-Marseille Université, Intensive Care Unit, Department of Cardiology, Assistance Publique-Hôpitaux de Marseille, Hôpital Nord, Marseille, France; Mediterranean Association for Research and Studies in Cardiology, Marseille, France; Centre for CardioVascular and Nutrition Research, INSERM 1263, INRA 1260, Marseille, France. Electronic address: laurent.bonello@ap-hm.fr.'}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2020.01.231']
149,32327093,"BMI, Infarct Size, and Clinical Outcomes Following Primary PCI: Patient-Level Analysis From 6 Randomized Trials.","OBJECTIVES


The aim of this study was to examine the association between body mass index (BMI), infarct size (IS) and clinical outcomes.
BACKGROUND


The association between obesity, IS, and prognosis in patients undergoing primary percutaneous coronary intervention (pPCI) for ST-segment elevation myocardial infarction is incompletely understood.
METHODS


An individual patient-data pooled analysis was performed from 6 randomized trials of patients undergoing pPCI for ST-segment elevation myocardial infarction in which IS (percentage left ventricular mass) was assessed within 1 month (median 4 days) after randomization using either cardiac magnetic resonance (5 studies) or  99m Tc sestamibi single-photon emission computed tomography (1 study). Patients were classified as normal weight (BMI <25 kg/m 2 ), overweight (25 kg/m 2  ≤BMI <30 kg/m 2 ), or obese (BMI ≥30 kg/m 2 ). The multivariable models were adjusted for age, sex, hypertension, hyperlipidemia, current smoking, left main or left anterior descending coronary artery infarct, baseline TIMI (Thrombolysis In Myocardial Infarction) flow grade 0 or 1, prior myocardial infarction, symptom-to-first device time, and study.
RESULTS


Among 2,238 patients undergoing pPCI, 644 (29%) were normal weight, 1,008 (45%) were overweight, and 586 (26%) were obese. BMI was not significantly associated with IS, microvascular obstruction, or left ventricular ejection fraction in adjusted or unadjusted analysis. BMI was also not associated with the 1-year composite risk for death or heart failure hospitalization (adjusted hazard ratio: 1.21 [95% confidence interval: 0.74 to 1.71] for overweight vs. normal [p = 0.59]; adjusted hazard ratio: 1.21 [95% confidence interval 0.74 to 1.97] for obese vs. normal [p = 0.45]) or for death or heart failure hospitalization separately. Results were consistent when BMI was modeled as a continuous variable.
CONCLUSIONS


In this individual patient-data pooled analysis of 2,238 patients undergoing pPCI for ST-segment elevation myocardial infarction, BMI was not associated with IS, microvascular obstruction, left ventricular ejection fraction, or 1-year rates of death or heart failure hospitalization.",2020,"BMI was not significantly associated with IS, microvascular obstruction, or left ventricular ejection fraction in adjusted or unadjusted analysis.","['patients undergoing primary percutaneous\xa0coronary intervention (pPCI) for ST-segment elevation myocardial infarction', '2,238 patients undergoing pPCI, 644 (29%) were normal weight, 1,008 (45%) were overweight, and 586 (26%) were obese', 'patients undergoing pPCI for ST-segment elevation myocardial infarction in which IS (percentage left ventricular mass', 'left anterior descending coronary artery infarct, baseline TIMI (Thrombolysis In Myocardial Infarction) flow grade 0 or 1, prior myocardial infarction, symptom-to-first device time, and study', 'Patients were classified as normal weight (BMI\xa0<25\xa0kg/m 2 ), overweight (25\xa0kg/m 2 \xa0≤BMI\xa0<30\xa0kg/m 2 ), or obese (BMI\xa0≥30\xa0kg/m 2 ', '2,238 patients undergoing']","['pPCI', 'Primary PCI', 'cardiac magnetic resonance (5 studies) or  99m Tc sestamibi single-photon emission computed tomography']","['1-year composite risk for death or heart failure hospitalization', 'death or heart failure hospitalization separately', 'body mass index (BMI), infarct size (IS) and clinical outcomes', 'IS, microvascular obstruction, or left ventricular ejection fraction', 'BMI', 'BMI, Infarct Size, and Clinical Outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}, {'cui': 'C2712185', 'cui_str': 'Normal weight'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0455825', 'cui_str': 'Left ventricular mass'}, {'cui': 'C0226032', 'cui_str': 'Structure of anterior descending branch of left coronary artery'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0155668', 'cui_str': 'Old myocardial infarction'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0162680', 'cui_str': 'Technetium Tc 99m Sestamibi'}, {'cui': 'C0040399', 'cui_str': 'Single photon emission computerized tomography'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}]",2238.0,0.173923,"BMI was not significantly associated with IS, microvascular obstruction, or left ventricular ejection fraction in adjusted or unadjusted analysis.","[{'ForeName': 'Bahira', 'Initials': 'B', 'LastName': 'Shahim', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Redfors', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York; Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Shmuel', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Thiele', 'Affiliation': 'Heart Center Leipzig at University of Leipzig and Leipzig Heart Institute, Leipzig, Germany.'}, {'ForeName': 'Ingo', 'Initials': 'I', 'LastName': 'Eitel', 'Affiliation': 'University Heart Center Lübeck and the German Center for Cardiovascular Research, Lübeck, Germany.'}, {'ForeName': 'Fotis', 'Initials': 'F', 'LastName': 'Gkargkoulas', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Crowley', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': 'Ori', 'Initials': 'O', 'LastName': 'Ben-Yehuda', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Maehara', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York. Electronic address: gstone@crf.org.'}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2020.02.004']
150,32327095,"Intravascular Ultrasound Pulmonary Artery Denervation to Treat Pulmonary Arterial Hypertension (TROPHY1): Multicenter, Early Feasibility Study.","OBJECTIVES


The aim of this study was to investigate whether therapeutic intravascular ultrasound pulmonary artery denervation (PDN) is safe and reduces pulmonary vascular resistance (PVR) in patients with pulmonary arterial hypertension (PAH) on a minimum of dual oral therapy.
BACKGROUND


Early studies have suggested that PDN can reduce PVR in patients with PAH.
METHODS


TROPHY1 (Treatment of Pulmonary Hypertension 1) was a multicenter, international, open-label trial undertaken at 8 specialist centers. Patients 18 to 75 years of age with PAH were eligible if taking dual oral or triple nonparenteral therapy and not responsive to acute vasodilator testing. Eligible patients underwent PDN (TIVUS System). The primary safety endpoint was procedure-related adverse events at 30 days. Secondary endpoints included procedure-related adverse events, disease worsening and death to 12 months, and efficacy endpoints that included change in pulmonary hemodynamic status, 6-min walk distance, and quality of life from baseline to 4 or 6 months. Patients were to remain on disease-specific medication for the duration of the study.
RESULTS


Twenty-three patients underwent PDN, with no procedure-related serious adverse events reported. The reduction in PVR at 4- or 6-month follow-up was 94 ± 151 dyn·s·cm -5  (p = 0.001) or 17.8%, which was associated with a 42 ± 63 m (p = 0.02) increase in 6-min walk distance and a 671 ± 1,555 step (p = 0.04) increase in daily activity.
CONCLUSIONS


In this multicenter early feasibility study, PDN with an intravascular ultrasound catheter was performed without procedure-related adverse events and was associated with a reduction in PVR and increases in 6-min walk distance and daily activity in patients with PAH on background dual or triple therapy.",2020,"The reduction in PVR at 4- or 6-month follow-up was 94 ± 151 dyn·s·cm -5  (p = 0.001) or 17.8%, which was associated with a 42 ± 63 m (p = 0.02) increase in 6-min walk distance and a 671 ± 1,555 step (p = 0.04) increase in daily activity.
","['Patients 18 to 75 years of age with PAH were eligible if taking dual oral or triple nonparenteral therapy and not responsive to acute vasodilator testing', 'patients with PAH on background dual or triple therapy', 'Eligible patients underwent PDN (TIVUS System', 'Pulmonary Arterial Hypertension (TROPHY1', 'patients with pulmonary arterial hypertension (PAH', 'patients with PAH']","['TROPHY1 ', 'Intravascular Ultrasound Pulmonary Artery Denervation', 'therapeutic intravascular ultrasound pulmonary artery denervation (PDN', 'intravascular ultrasound catheter', 'PDN']","['reduction in PVR', 'procedure-related adverse events, disease worsening and death to 12\xa0months, and efficacy endpoints that included change in pulmonary hemodynamic status, 6-min walk distance, and quality of life', '6-min walk distance and daily activity', '6-min walk distance', 'pulmonary vascular resistance (PVR', 'procedure-related adverse events', 'daily activity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C2973725', 'cui_str': 'Pulmonary arterial hypertension'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0237284', 'cui_str': 'Unresponsive'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0042402', 'cui_str': 'Vasodilator agent'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0034052', 'cui_str': 'Pulmonary artery structure'}, {'cui': 'C0011307', 'cui_str': 'Denervation - action'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0442123', 'cui_str': 'Intravascular'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0034052', 'cui_str': 'Pulmonary artery structure'}, {'cui': 'C0011307', 'cui_str': 'Denervation - action'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0456261', 'cui_str': 'Pulmonary vascular resistance'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}]",23.0,0.0675557,"The reduction in PVR at 4- or 6-month follow-up was 94 ± 151 dyn·s·cm -5  (p = 0.001) or 17.8%, which was associated with a 42 ± 63 m (p = 0.02) increase in 6-min walk distance and a 671 ± 1,555 step (p = 0.04) increase in daily activity.
","[{'ForeName': 'Alexander M K', 'Initials': 'AMK', 'LastName': 'Rothman', 'Affiliation': 'University of Sheffield and Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, United Kingdom. Electronic address: a.rothman@sheffield.ac.uk.'}, {'ForeName': 'Jean-Luc', 'Initials': 'JL', 'LastName': 'Vachiery', 'Affiliation': 'Cliniques Universitaires de Bruxelles, Erasme Hospital, Brussels, Belgium.'}, {'ForeName': 'Luke S', 'Initials': 'LS', 'LastName': 'Howard', 'Affiliation': 'Hammersmith Hospital, Imperial College Healthcare NHS Trust, London, United Kingdom.'}, {'ForeName': 'Ghada W', 'Initials': 'GW', 'LastName': 'Mikhail', 'Affiliation': 'Hammersmith Hospital, Imperial College Healthcare NHS Trust, London, United Kingdom.'}, {'ForeName': 'Irene M', 'Initials': 'IM', 'LastName': 'Lang', 'Affiliation': 'Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Jonas', 'Affiliation': 'Kaplan Medical Center, Rehovot, Israel.'}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Kiely', 'Affiliation': 'University of Sheffield and Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, United Kingdom.'}, {'ForeName': 'Dalit', 'Initials': 'D', 'LastName': 'Shav', 'Affiliation': 'SoniVie, Rosh Haayin, Israel.'}, {'ForeName': 'Or', 'Initials': 'O', 'LastName': 'Shabtay', 'Affiliation': 'SoniVie, Rosh Haayin, Israel.'}, {'ForeName': 'Avital', 'Initials': 'A', 'LastName': 'Avriel', 'Affiliation': 'Barzilai Medical Center, Ashkelon, Israel.'}, {'ForeName': 'Gregory D', 'Initials': 'GD', 'LastName': 'Lewis', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Erika B', 'Initials': 'EB', 'LastName': 'Rosenzweig', 'Affiliation': 'University of Columbia Medical Center, NewYork-Presbyterian Hospital, New York, New York.'}, {'ForeName': 'Ajay J', 'Initials': 'AJ', 'LastName': 'Kirtane', 'Affiliation': 'University of Columbia Medical Center, NewYork-Presbyterian Hospital, New York, New York; Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': 'Nick H', 'Initials': 'NH', 'LastName': 'Kim', 'Affiliation': 'University of California, San Diego, San Diego, California.'}, {'ForeName': 'Ehtisham', 'Initials': 'E', 'LastName': 'Mahmud', 'Affiliation': 'University of California, San Diego, San Diego, California.'}, {'ForeName': 'Vallerie V', 'Initials': 'VV', 'LastName': 'McLaughlain', 'Affiliation': 'University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Chetcuti', 'Affiliation': 'University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Martin B', 'Initials': 'MB', 'LastName': 'Leon', 'Affiliation': 'University of Columbia Medical Center, NewYork-Presbyterian Hospital, New York, New York; Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': 'Ori', 'Initials': 'O', 'LastName': 'Ben-Yehuda', 'Affiliation': 'Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': 'Lewis J', 'Initials': 'LJ', 'LastName': 'Rubin', 'Affiliation': 'University of California, San Diego, San Diego, California.'}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2019.12.027']
151,30734388,Highly-accelerated volumetric brain examination using optimized wave-CAIPI encoding.,"BACKGROUND


Rapid volumetric imaging protocols could better utilize limited scanner resources.
PURPOSE


To develop and validate an optimized 6-minute high-resolution volumetric brain MRI examination using Wave-CAIPI encoding.
STUDY TYPE


Prospective.
POPULATION/SUBJECTS


Ten healthy subjects and 20 patients with a variety of intracranial pathologies.
FIELD STRENGTH/SEQUENCE


At 3 T, MPRAGE, T 2  -weighted SPACE, SPACE FLAIR, and SWI were acquired at 9-fold acceleration using Wave-CAIPI and for comparison at 2-4-fold acceleration using conventional GRAPPA.
ASSESSMENT


Extensive simulations were performed to optimize the Wave-CAIPI protocol and minimize both g-factor noise amplification and potential T 1  /T 2  blurring artifacts. Moreover, refinements in the autocalibrated reconstruction of Wave-CAIPI were developed to ensure high-quality reconstructions in the presence of gradient imperfections. In a randomized and blinded fashion, three neuroradiologists assessed the diagnostic quality of the optimized 6-minute Wave-CAIPI exam and compared it to the roughly 3× slower GRAPPA accelerated protocol using both an individual and head-to-head analysis.
STATISTICAL TEST


A noninferiority test was used to test whether the diagnostic quality of Wave-CAIPI was noninferior to the GRAPPA acquisition, with a 15% noninferiority margin.
RESULTS


Among all sequences, Wave-CAIPI achieved negligible g-factor noise amplification (g avg   ≤ 1.04) and burring artifacts from T 1  /T 2  relaxation. Improvements of our autocalibration approach for gradient imperfections enabled increased robustness to gradient mixing imperfections in tilted-field of view (FOV) prescriptions as well as variations in gradient and analog-to-digital converter (ADC) sampling rates. In the clinical evaluation, Wave-CAIPI achieved similar mean scores when compared with GRAPPA (MPRAGE: Ø W   = 4.03, Ø G   = 3.97; T 2  w SPACE: Ø W   = 4.00, Ø G   = 4.00; SPACE FLAIR: Ø W   = 3.97, Ø G   = 3.97; SWI: Ø W   = 3.93, Ø G   = 3.83) and was statistically noninferior (N = 30, P < 0.05 for all sequences).
DATA CONCLUSION


The proposed volumetric brain exam retained comparable image quality when compared with the much longer conventional protocol.
LEVEL OF EVIDENCE


2 Technical Efficacy: Stage 1 J. Magn. Reson. Imaging 2019;50:961-974.",2019,"Among all sequences, Wave-CAIPI achieved negligible g-factor noise amplification (g avg   ≤ 1.04) and burring artifacts from T 1  /T",['Ten healthy subjects and 20 patients with a variety of intracranial pathologies'],[],"['diagnostic quality', 'diagnostic quality of Wave-CAIPI']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0524466', 'cui_str': 'Intracranial (qualifier value)'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}]",[],"[{'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]",10.0,0.0371668,"Among all sequences, Wave-CAIPI achieved negligible g-factor noise amplification (g avg   ≤ 1.04) and burring artifacts from T 1  /T","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Polak', 'Affiliation': 'Department of Physics and Astronomy, Heidelberg University, Heidelberg, Germany.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Cauley', 'Affiliation': 'Department of Radiology, A. A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Charlestown, Massachusetts, USA.'}, {'ForeName': 'Susie Y', 'Initials': 'SY', 'LastName': 'Huang', 'Affiliation': 'Department of Radiology, A. A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Charlestown, Massachusetts, USA.'}, {'ForeName': 'Maria Gabriela', 'Initials': 'MG', 'LastName': 'Longo', 'Affiliation': 'Division of Neuroradiology, Department of Radiology, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Conklin', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Berkin', 'Initials': 'B', 'LastName': 'Bilgic', 'Affiliation': 'Department of Radiology, A. A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Charlestown, Massachusetts, USA.'}, {'ForeName': 'Ned', 'Initials': 'N', 'LastName': 'Ohringer', 'Affiliation': 'Department of Radiology, A. A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Charlestown, Massachusetts, USA.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Raithel', 'Affiliation': 'Siemens Healthcare, Erlangen, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bachert', 'Affiliation': 'Department of Physics and Astronomy, Heidelberg University, Heidelberg, Germany.'}, {'ForeName': 'Lawrence L', 'Initials': 'LL', 'LastName': 'Wald', 'Affiliation': 'Department of Radiology, A. A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Charlestown, Massachusetts, USA.'}, {'ForeName': 'Kawin', 'Initials': 'K', 'LastName': 'Setsompop', 'Affiliation': 'Department of Radiology, A. A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Charlestown, Massachusetts, USA.'}]",Journal of magnetic resonance imaging : JMRI,['10.1002/jmri.26678']
152,31559532,Clinical and MRI efficacy of sc IFN β-1a tiw in patients with relapsing MS appearing to transition to secondary progressive MS: post hoc analyses of PRISMS and SPECTRIMS.,"This study evaluated efficacy of subcutaneous (sc) interferon beta-1a (IFN β-1a) 44 µg 3 × weekly (tiw) in patients appearing to transition from relapsing-remitting multiple sclerosis (RRMS) to secondary progressive MS (SPMS). The PRISMS study included 560 patients with RRMS (EDSS 0-5.0; ≥ 2 relapses in previous 2 years), and the SPECTRIMS study included 618 patients with SPMS (EDSS 3.0-6.5 and ≥ 1-point increase in previous 2 years [≥ 0.5 point if 6.0-6.5]) randomly assigned to sc IFN β-1a 44 or 22 µg or placebo for 2-3 years, respectively. These post hoc analyses examined five subgroups of MS patients with EDSS 4.0-6.0: PRISMS (n = 59), PRISMS/SPECTRIMS (n = 335), PRISMS/SPECTRIMS with baseline disease activity (n = 195; patients with either ≥ 1 relapse within 2 years before baseline or ≥ 1 gadolinium-enhancing lesion at baseline), PRISMS/SPECTRIMS without baseline disease activity (n = 140), and PRISMS/SPECTRIMS with disease activity during the study (n = 202). In the PRISMS and PRISMS/SPECTRIMS subgroups, sc IFN β-1a delayed disability progression, although no significant effect was observed in PRISMS/SPECTRIMS subgroups with activity at baseline or activity during the study (regardless of baseline activity). In the PRISMS/SPECTRIMS subgroup, over year 1 (0-1) and 2 (0-2), sc IFN β-1a 44 µg tiw significantly reduced annualized relapse rate (p ≤ 0.001), and relapse risk (p < 0.05) versus placebo. Similar results were seen for the PRISMS/SPECTRIMS with baseline disease activity subgroup. Subcutaneous IFN β-1a reduced T2 burden of disease and active T2 lesions in the PRISMS/SPECTRIMS subgroups overall, with and without baseline activity. In conclusion, these post hoc analyses indicate that effects of sc IFN β-1a 44 µg tiw on clinical/MRI endpoints are preserved in a patient subgroup appearing to transition between RRMS and SPMS.",2020,"Subcutaneous IFN β-1a reduced T2 burden of disease and active T2 lesions in the PRISMS/SPECTRIMS subgroups overall, with and without baseline activity.","['560 patients with RRMS (EDSS 0-5.0;\u2009≥\u20092 relapses in previous 2\xa0years), and the SPECTRIMS study included 618 patients with SPMS (EDSS 3.0-6.5 and\u2009≥\u20091-point increase in previous 2\xa0years [≥\u20090.5 point if 6.0-6.5]) randomly assigned to']","['placebo', 'subcutaneous (sc) interferon beta-1a (IFN β-1a', 'sc IFN β-1a 44 or 22\xa0µg or placebo']","['disability progression', 'annualized relapse rate', 'T2 burden of disease and active T2 lesions', 'relapse risk']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0254119', 'cui_str': 'Interferon beta-1a'}]","[{'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",618.0,0.040239,"Subcutaneous IFN β-1a reduced T2 burden of disease and active T2 lesions in the PRISMS/SPECTRIMS subgroups overall, with and without baseline activity.","[{'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Freedman', 'Affiliation': 'University of Ottawa and the Ottawa Hospital Research Institute, 501 Smyth Road, Ottawa, ON, K1H 8L6, Canada. mfreedman@toh.ca.'}, {'ForeName': 'Staley', 'Initials': 'S', 'LastName': 'Brod', 'Affiliation': 'Medical College of Wisconsin, Milwaukee, WI, USA.'}, {'ForeName': 'Barry A', 'Initials': 'BA', 'LastName': 'Singer', 'Affiliation': 'Missouri Baptist Medical Center, St. Louis, MO, USA.'}, {'ForeName': 'Bruce A', 'Initials': 'BA', 'LastName': 'Cohen', 'Affiliation': 'Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Brooke', 'Initials': 'B', 'LastName': 'Hayward', 'Affiliation': 'EMD Serono, Inc., Rockland, MA, USA.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Dangond', 'Affiliation': 'EMD Serono, Inc., Billerica, MA, USA.'}, {'ForeName': 'Patricia K', 'Initials': 'PK', 'LastName': 'Coyle', 'Affiliation': 'Stony Brook University Medical Center, Stony Brook, NY, USA.'}]",Journal of neurology,['10.1007/s00415-019-09532-5']
153,32324615,Concentric and Eccentric Resistance Training Comparison on Physical Function and Functional Pain Outcomes in Knee Osteoarthritis: A Randomized Controlled Trial.,"OBJECTIVE


The aim of the study was to compare the effectiveness of concentrically focused resistance training to eccentrically focused resistance training on physical function and functional pain in knee osteoarthritis.
DESIGN


This is a randomized, single-blinded controlled 4-mo trial. Older adults with knee osteoarthritis (N = 88; 68.3 ± 6.4 yrs, 30.4 ± 6.9 kg/m, and 67.4% women) were randomized to eccentrically focused resistance training, concentrically focused resistance training, or no-exercise control. Main outcomes included chair rise time, stair climb time, 6-min walk test distance, temporal-spatial parameters of gait, community ambulation, and functional pain.
RESULTS


Leg muscle strength improved in both training groups compared with no-exercise control. There were no significant group × time interactions for any functional performance score (chair rise time, stair climb time, 6-min walk test distance, gait parameters, community ambulation). Compared with no-exercise control, functional pain scores were reduced for chair rise (-38.6% concentrically focused resistance training, -50.3% eccentrically focused resistance training vs. +10.0%) and stair climb (-51.6% concentrically focused resistance training, -41.3% eccentrically focused resistance training vs. +80.7%; all P < 0.05). Pain scores were reduced during the 6-min walk and in early recovery with concentrically focused resistance training compared with the remaining two groups (P < 0.05).
CONCLUSIONS


Either resistance exercise type improves activity-related knee osteoarthritis pain, but concentrically focused resistance training more effectively reduced severity of ambulatory pain and pain upon walking cessation.",2020,"Pain scores were reduced during the six-minute walk and in early recovery with CNCRT compared to the remaining two groups (p<0.05).
","['knee osteoarthritis (OA', 'Knee Osteoarthritis', 'Older adults with knee OA (N=88; 68.3±6.4 yr, 30.4±6.9 kg/m and 67.4% women']","['resistance exercise type', 'concentrically-focused resistance training (CNCRT) to eccentrically-focused resistance training (ECCRT', 'ECCRT, CNCRT or no-exercise control (CON', 'Concentric and Eccentric Resistance Training Comparison']","['physical function and functional pain', 'ambulatory pain and pain upon walking cessation', 'CON, functional pain scores', 'Pain scores', 'functional performance score (chair rise time, stair climb time, six-minute walk test distance, gait parameters, community ambulation', 'Leg muscle strength', 'Physical Function and Functional Pain Outcomes', 'chair rise time, stair climb time, six-minute walk test distance, temporalspatial parameters of gait, community ambulation and functional pain', 'chair rise', 'stair climb', 'activity-related knee OA pain']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439744', 'cui_str': 'Concentric'}, {'cui': 'C0439740', 'cui_str': 'Eccentric'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0432601', 'cui_str': 'Stairs climbed'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0224456', 'cui_str': 'Skeletal muscle structure of lower leg'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}]",,0.0567988,"Pain scores were reduced during the six-minute walk and in early recovery with CNCRT compared to the remaining two groups (p<0.05).
","[{'ForeName': 'Kevin R', 'Initials': 'KR', 'LastName': 'Vincent', 'Affiliation': 'From the Divisions of Physical Medicine and Rehabilitation, Sports Medicine and Research, Department of Orthopaedics and Rehabilitation, University of Florida, Gainesville, Florida.'}, {'ForeName': 'Heather K', 'Initials': 'HK', 'LastName': 'Vincent', 'Affiliation': ''}]",American journal of physical medicine & rehabilitation,['10.1097/PHM.0000000000001450']
154,32324651,The Effect of Adalimumab Treatment on Linear Growth in Children With Crohn Disease: A Post-hoc Analysis of the PAILOT Randomized Control Trial.,"OBJECTIVES


Growth impairment is common in children with Crohn disease (CD). We aimed to assess the effect of adalimumab (ADL) treatment on linear growth in children with CD in a post-hoc analysis of the Pediatric Crohn's Disease AdalImumab Level-based Optimization Treatment randomized controlled trial.
METHODS


Children 6 to 17 years who responded to ADL induction were assessed consecutively for anthropometric parameters. Associations of these parameters with disease characteristics and disease activity were analyzed.
RESULTS


Overall, 66 patients completed 72 weeks of follow-up (25% girls, mean age of 15.6 ± 2.5 years). Median (interquartile range [IQR]) height z score improved from -0.6 (-1.6-0.15) at baseline to -0.33 (-1.3-0.5) at week 72 (P = 0.005) with lesser improvement in patients with perianal disease. Similar effect was noted in children with growth potential (boys younger than 16 years, girls younger than 14 years). Median (IQR) height velocity standard deviation was -0.32 (-1.5-0.8) at week 26, and +0.11 (-1.1-1.3) at week 72. Median weight z score increased from -0.54 (-1.2-0.15) to -0.1 (-0.9-0.6), P < 0.001 and body mass index from -0.4 (-1.0-0.5) to 0.0 (-0.8-0.9), P = 0.005. Pediatric CD activity index and erythrocyte sedimentation rate at week 4 correlated negatively with height z score changes (P = 0.043 and P = 0.048, respectively), whereas sustained clinical and biologic remission (week 4-72) were positively associated with changes in height z scores. Significant improvement in linear growth was predicted by lower pediatric CD activity index and erythrocyte sedimentation rate at the end of induction and sustained clinical remission (P = 0.05) and sustained normal C-reactive protein (P = 0.001) at all visits.
CONCLUSION


In children with moderate-to-severe CD, ADL treatment had a significant effect on linear growth, with normalization of weight and body mass index (clinicaltrials.gov no: NCT02256462).",2020,Pediatric CD activity index (PCDAI) and erythrocyte sedimentation rate (ESR) at week 4 correlated negatively with height z-score changes (p = ,"[""children with Crohn's disease (CD"", '66 patients completed 72 weeks of follow-up [25% females, mean age of 15.6\u200a±\u200a2.5 years', 'children with CD', 'children with growth potential (boys\u200a<\u200a16 years, girls<14 years', 'patients with perianal disease', ""Children with Crohn's Disease"", 'Children 6-17 years who responded to ADL induction were assessed consecutively for anthropometric parameters']","['adalimumab (ADL', 'Adalimumab']","['Pediatric CD activity index (PCDAI) and erythrocyte sedimentation rate (ESR', 'Median weight z-score', 'Median (IQR) height velocity standard deviation', 'linear growth, with normalization of weight and BMI', 'Linear Growth', 'Median (IQR) height z-score', 'sustained clinical and biologic remission', 'height z-scores', 'lower PCDAI and ESR at the end of induction and sustained clinical remission', 'linear growth', 'sustained normal C-reactive protein']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0442158', 'cui_str': 'Perianal'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]","[{'cui': 'C1122087', 'cui_str': 'adalimumab'}]","[{'cui': 'C2931133', 'cui_str': ""Pediatric Crohn's disease""}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}, {'cui': 'C0013845', 'cui_str': 'Electron spin resonance measurement'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}]",72.0,0.113056,Pediatric CD activity index (PCDAI) and erythrocyte sedimentation rate (ESR) at week 4 correlated negatively with height z-score changes (p = ,"[{'ForeName': 'Manar', 'Initials': 'M', 'LastName': 'Matar', 'Affiliation': ""The Institute of Gastroenterology, Nutrition and Liver Diseases, Schneider Children's Hospital, Petach-Tikva.""}, {'ForeName': 'Raanan', 'Initials': 'R', 'LastName': 'Shamir', 'Affiliation': ""The Institute of Gastroenterology, Nutrition and Liver Diseases, Schneider Children's Hospital, Petach-Tikva.""}, {'ForeName': 'Raffi', 'Initials': 'R', 'LastName': 'Lev-Zion', 'Affiliation': 'The Juliet Keidan institute of Pediatric Gastroenterology, Nutrition, Shaare Zedek Medical Center, The Hebrew University, Jerusalem.'}, {'ForeName': 'Efrat', 'Initials': 'E', 'LastName': 'Broide', 'Affiliation': 'The Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv.'}, {'ForeName': 'Batia', 'Initials': 'B', 'LastName': 'Weiss', 'Affiliation': 'The Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv.'}, {'ForeName': 'Oren', 'Initials': 'O', 'LastName': 'Ledder', 'Affiliation': 'The Juliet Keidan institute of Pediatric Gastroenterology, Nutrition, Shaare Zedek Medical Center, The Hebrew University, Jerusalem.'}, {'ForeName': 'Anat', 'Initials': 'A', 'LastName': 'Guz-Mark', 'Affiliation': ""The Institute of Gastroenterology, Nutrition and Liver Diseases, Schneider Children's Hospital, Petach-Tikva.""}, {'ForeName': 'Firas', 'Initials': 'F', 'LastName': 'Rinawi', 'Affiliation': ""The Institute of Gastroenterology, Nutrition and Liver Diseases, Schneider Children's Hospital, Petach-Tikva.""}, {'ForeName': 'Shlomi', 'Initials': 'S', 'LastName': 'Cohen', 'Affiliation': 'The Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv.'}, {'ForeName': 'Chani', 'Initials': 'C', 'LastName': 'Topf-Olivestone', 'Affiliation': 'Pediatric Gastroenterology Unit, Kaplan Medical Center, Rehovot.'}, {'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Shaoul', 'Affiliation': 'Pediatric Gastroenterology Unit, Rambam Medical Center, Haifa.'}, {'ForeName': 'Baruch', 'Initials': 'B', 'LastName': 'Yerushalmi', 'Affiliation': 'Pediatric Gastroenterology Unit, Soroka University Medical Center and Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Assa', 'Affiliation': ""The Institute of Gastroenterology, Nutrition and Liver Diseases, Schneider Children's Hospital, Petach-Tikva.""}]",Journal of pediatric gastroenterology and nutrition,['10.1097/MPG.0000000000002728']
155,32227754,Health Status after Invasive or Conservative Care in Coronary and Advanced Kidney Disease.,"BACKGROUND


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


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


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


Participants with stable ischemic heart disease, moderate or severe ischemia, and advanced chronic kidney disease did not have substantial or sustained benefits with regard to angina-related health status with an initially invasive strategy as compared with a conservative strategy. (Funded by the National Heart, Lung, and Blood Institute; ISCHEMIA-CKD ClinicalTrials.gov number, NCT01985360.).",2020,"The mean difference in score at 3 months was largest among participants with daily or weekly angina at baseline (10.1 points; 95% credible interval, 0.0 to 19.9), smaller among those with monthly angina at baseline (2.2 points; 95% credible interval, -2.0 to 6.2), and nearly absent among those without angina at baseline (0.6 points; 95% credible interval, -1.9 to 3.3).","['Health Status after Invasive or Conservative Care in Coronary and Advanced Kidney Disease', 'Participants with stable ischemic heart disease, moderate or severe ischemia, and advanced chronic kidney disease', 'participants with stable ischemic heart disease, moderate or severe ischemia, and advanced chronic kidney disease (an estimated glomerular filtration rate of <30 ml per minute per 1.73 m 2  or receipt of dialysis', 'Health status was assessed in 705 of 777 participants']",['guideline-based medical therapy alone (conservative strategy'],"['health status with the Seattle Angina Questionnaire (SAQ', 'frequent angina and better function and quality of life', 'overall trial population', 'SAQ Summary score', 'risk of death or myocardial infarction']","[{'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0022658', 'cui_str': 'Kidney Diseases'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0151744', 'cui_str': 'Ischemic Heart Disease'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C3811844'}, {'cui': 'C0702093', 'cui_str': '/min'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}]","[{'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}]","[{'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C0002962', 'cui_str': 'Stenocardia'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0034380'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}]",777.0,0.272639,"The mean difference in score at 3 months was largest among participants with daily or weekly angina at baseline (10.1 points; 95% credible interval, 0.0 to 19.9), smaller among those with monthly angina at baseline (2.2 points; 95% credible interval, -2.0 to 6.2), and nearly absent among those without angina at baseline (0.6 points; 95% credible interval, -1.9 to 3.3).","[{'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Spertus', 'Affiliation': ""From Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City, Kansas City (J.A.S., P.G.J.), and the Center for Comprehensive Cardiovascular Care, St. Louis University School of Medicine, St. Louis (B.R.C.) - all in Missouri; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (D.B.M., S.M.O.); the National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (J.L.F.); and New York University Grossman School of Medicine (H.R.R., J.S.H., S.B.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York, and Albany Medical College and Albany Medical Center, Albany (M.S.S.) - all in New York.""}, {'ForeName': 'Philip G', 'Initials': 'PG', 'LastName': 'Jones', 'Affiliation': ""From Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City, Kansas City (J.A.S., P.G.J.), and the Center for Comprehensive Cardiovascular Care, St. Louis University School of Medicine, St. Louis (B.R.C.) - all in Missouri; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (D.B.M., S.M.O.); the National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (J.L.F.); and New York University Grossman School of Medicine (H.R.R., J.S.H., S.B.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York, and Albany Medical College and Albany Medical Center, Albany (M.S.S.) - all in New York.""}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Maron', 'Affiliation': ""From Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City, Kansas City (J.A.S., P.G.J.), and the Center for Comprehensive Cardiovascular Care, St. Louis University School of Medicine, St. Louis (B.R.C.) - all in Missouri; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (D.B.M., S.M.O.); the National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (J.L.F.); and New York University Grossman School of Medicine (H.R.R., J.S.H., S.B.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York, and Albany Medical College and Albany Medical Center, Albany (M.S.S.) - all in New York.""}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Mark', 'Affiliation': ""From Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City, Kansas City (J.A.S., P.G.J.), and the Center for Comprehensive Cardiovascular Care, St. Louis University School of Medicine, St. Louis (B.R.C.) - all in Missouri; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (D.B.M., S.M.O.); the National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (J.L.F.); and New York University Grossman School of Medicine (H.R.R., J.S.H., S.B.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York, and Albany Medical College and Albany Medical Center, Albany (M.S.S.) - all in New York.""}, {'ForeName': 'Sean M', 'Initials': 'SM', 'LastName': ""O'Brien"", 'Affiliation': ""From Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City, Kansas City (J.A.S., P.G.J.), and the Center for Comprehensive Cardiovascular Care, St. Louis University School of Medicine, St. Louis (B.R.C.) - all in Missouri; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (D.B.M., S.M.O.); the National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (J.L.F.); and New York University Grossman School of Medicine (H.R.R., J.S.H., S.B.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York, and Albany Medical College and Albany Medical Center, Albany (M.S.S.) - all in New York.""}, {'ForeName': 'Jerome L', 'Initials': 'JL', 'LastName': 'Fleg', 'Affiliation': ""From Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City, Kansas City (J.A.S., P.G.J.), and the Center for Comprehensive Cardiovascular Care, St. Louis University School of Medicine, St. Louis (B.R.C.) - all in Missouri; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (D.B.M., S.M.O.); the National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (J.L.F.); and New York University Grossman School of Medicine (H.R.R., J.S.H., S.B.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York, and Albany Medical College and Albany Medical Center, Albany (M.S.S.) - all in New York.""}, {'ForeName': 'Harmony R', 'Initials': 'HR', 'LastName': 'Reynolds', 'Affiliation': ""From Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City, Kansas City (J.A.S., P.G.J.), and the Center for Comprehensive Cardiovascular Care, St. Louis University School of Medicine, St. Louis (B.R.C.) - all in Missouri; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (D.B.M., S.M.O.); the National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (J.L.F.); and New York University Grossman School of Medicine (H.R.R., J.S.H., S.B.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York, and Albany Medical College and Albany Medical Center, Albany (M.S.S.) - all in New York.""}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': ""From Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City, Kansas City (J.A.S., P.G.J.), and the Center for Comprehensive Cardiovascular Care, St. Louis University School of Medicine, St. Louis (B.R.C.) - all in Missouri; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (D.B.M., S.M.O.); the National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (J.L.F.); and New York University Grossman School of Medicine (H.R.R., J.S.H., S.B.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York, and Albany Medical College and Albany Medical Center, Albany (M.S.S.) - all in New York.""}, {'ForeName': 'Mandeep S', 'Initials': 'MS', 'LastName': 'Sidhu', 'Affiliation': ""From Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City, Kansas City (J.A.S., P.G.J.), and the Center for Comprehensive Cardiovascular Care, St. Louis University School of Medicine, St. Louis (B.R.C.) - all in Missouri; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (D.B.M., S.M.O.); the National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (J.L.F.); and New York University Grossman School of Medicine (H.R.R., J.S.H., S.B.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York, and Albany Medical College and Albany Medical Center, Albany (M.S.S.) - all in New York.""}, {'ForeName': 'Bernard R', 'Initials': 'BR', 'LastName': 'Chaitman', 'Affiliation': ""From Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City, Kansas City (J.A.S., P.G.J.), and the Center for Comprehensive Cardiovascular Care, St. Louis University School of Medicine, St. Louis (B.R.C.) - all in Missouri; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (D.B.M., S.M.O.); the National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (J.L.F.); and New York University Grossman School of Medicine (H.R.R., J.S.H., S.B.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York, and Albany Medical College and Albany Medical Center, Albany (M.S.S.) - all in New York.""}, {'ForeName': 'Glenn M', 'Initials': 'GM', 'LastName': 'Chertow', 'Affiliation': ""From Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City, Kansas City (J.A.S., P.G.J.), and the Center for Comprehensive Cardiovascular Care, St. Louis University School of Medicine, St. Louis (B.R.C.) - all in Missouri; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (D.B.M., S.M.O.); the National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (J.L.F.); and New York University Grossman School of Medicine (H.R.R., J.S.H., S.B.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York, and Albany Medical College and Albany Medical Center, Albany (M.S.S.) - all in New York.""}, {'ForeName': 'Judith S', 'Initials': 'JS', 'LastName': 'Hochman', 'Affiliation': ""From Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City, Kansas City (J.A.S., P.G.J.), and the Center for Comprehensive Cardiovascular Care, St. Louis University School of Medicine, St. Louis (B.R.C.) - all in Missouri; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (D.B.M., S.M.O.); the National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (J.L.F.); and New York University Grossman School of Medicine (H.R.R., J.S.H., S.B.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York, and Albany Medical College and Albany Medical Center, Albany (M.S.S.) - all in New York.""}, {'ForeName': 'Sripal', 'Initials': 'S', 'LastName': 'Bangalore', 'Affiliation': ""From Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City, Kansas City (J.A.S., P.G.J.), and the Center for Comprehensive Cardiovascular Care, St. Louis University School of Medicine, St. Louis (B.R.C.) - all in Missouri; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (D.B.M., S.M.O.); the National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (J.L.F.); and New York University Grossman School of Medicine (H.R.R., J.S.H., S.B.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York, and Albany Medical College and Albany Medical Center, Albany (M.S.S.) - all in New York.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1916374']
156,32227756,Management of Coronary Disease in Patients with Advanced Kidney Disease.,"BACKGROUND


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


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


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


Among patients with stable coronary disease, advanced chronic kidney disease, and moderate or severe ischemia, we did not find evidence that an initial invasive strategy, as compared with an initial conservative strategy, reduced the risk of death or nonfatal myocardial infarction. (Funded by the National Heart, Lung, and Blood Institute and others; ISCHEMIA-CKD ClinicalTrials.gov number, NCT01985360.).",2020,"The invasive strategy was associated with a higher incidence of stroke than the conservative strategy (hazard ratio, 3.76; 95% CI, 1.52 to 9.32; P = 0.004) and with a higher incidence of death or initiation of dialysis (hazard ratio, 1.48; 95% CI, 1.04 to 2.11; P = 0.03).
","['777 patients with advanced kidney disease and moderate or severe ischemia on stress testing to be treated with an', 'patients with stable coronary disease have routinely excluded those with advanced chronic kidney disease', 'patients with stable coronary disease, advanced chronic kidney disease, and moderate or severe ischemia', 'Patients with Advanced Kidney Disease']",['initial invasive strategy consisting of coronary angiography and revascularization (if appropriate) added to medical therapy or an initial conservative strategy consisting of medical therapy alone and angiography reserved for those in whom medical therapy'],"['risk of death or nonfatal myocardial infarction', '3-year event rate', 'composite of death, nonfatal myocardial infarction, or hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest', 'composite of death or nonfatal myocardial infarction', 'death or initiation of dialysis']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0022658', 'cui_str': 'Kidney Diseases'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}]","[{'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0085532', 'cui_str': 'Angiography of coronary arteries'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0002965', 'cui_str': 'Angina at Rest'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C2587207', 'cui_str': 'Resuscitate'}, {'cui': 'C0018790', 'cui_str': 'Cardiac Arrest'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}]",777.0,0.32092,"The invasive strategy was associated with a higher incidence of stroke than the conservative strategy (hazard ratio, 3.76; 95% CI, 1.52 to 9.32; P = 0.004) and with a higher incidence of death or initiation of dialysis (hazard ratio, 1.48; 95% CI, 1.04 to 2.11; P = 0.03).
","[{'ForeName': 'Sripal', 'Initials': 'S', 'LastName': 'Bangalore', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Maron', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Sean M', 'Initials': 'SM', 'LastName': ""O'Brien"", 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Jerome L', 'Initials': 'JL', 'LastName': 'Fleg', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Evgeny I', 'Initials': 'EI', 'LastName': 'Kretov', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Briguori', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Upendra', 'Initials': 'U', 'LastName': 'Kaul', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Harmony R', 'Initials': 'HR', 'LastName': 'Reynolds', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Mazurek', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Mandeep S', 'Initials': 'MS', 'LastName': 'Sidhu', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Berger', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Roy O', 'Initials': 'RO', 'LastName': 'Mathew', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Bockeria', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Broderick', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Radoslaw', 'Initials': 'R', 'LastName': 'Pracon', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Charles A', 'Initials': 'CA', 'LastName': 'Herzog', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Huang', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Boden', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Newman', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Ziad A', 'Initials': 'ZA', 'LastName': 'Ali', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Mark', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Spertus', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Karen P', 'Initials': 'KP', 'LastName': 'Alexander', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Bernard R', 'Initials': 'BR', 'LastName': 'Chaitman', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Glenn M', 'Initials': 'GM', 'LastName': 'Chertow', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Judith S', 'Initials': 'JS', 'LastName': 'Hochman', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1915925']
157,32320490,Effects of single green tea ingestion on pharmacokinetics of nadolol in healthy volunteers.,"AIMS


The aim of this study was to investigate the effects of a single green tea (GT), administered concomitantly or 1 hour before nadolol intake on nadolol pharmacokinetics.
METHODS


In a randomized 3-phase crossover study, 11 healthy volunteers received an oral administration of nadolol with, or 1 hour after preingestion of brewed GT, or with water in a volume of 150 mL.
RESULTS


Geometric mean ratio with 90% confidence interval for nadolol AUC 0-48  was 0.371 (0.303-0.439) with concomitant GT. In addition, ingestion of GT 1 hour before nadolol administration resulted in a significant reduction of nadolol AUC 0-48  with geometric mean ratio of 0.536 (0.406-0.665). There were no differences in time to maximal plasma concentration and renal clearance of nadolol among groups.
CONCLUSION


These results suggest that single concomitant ingestion of GT substantially decreases plasma concentrations of nadolol. Moreover, the reduction in nadolol bioavailability could persist for at least 1 hour after drinking a cup of GT.",2020,"There were no differences in t max  and renal clearance of nadolol among groups.
","['healthy volunteers', '11 healthy volunteers']","['single green tea (GT', 'single green tea ingestion', 'nadolol', 'oral administration of nadolol with, or 1 hour after pre-ingestion of brewed GT, or with water in a volume of 150 ml']","['plasma concentrations of nadolol', 'nadolol AUC', 'nadolol bioavailability', 'Geometric mean ratio (GMR', 't max  and renal clearance']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C1384640', 'cui_str': 'Green tea'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0027302', 'cui_str': 'Nadolol'}, {'cui': 'C0001563', 'cui_str': 'Medication administration: oral'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C4321486', 'cui_str': '150'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0027302', 'cui_str': 'Nadolol'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0232813', 'cui_str': 'Renal clearance'}]",11.0,0.0518496,"There were no differences in t max  and renal clearance of nadolol among groups.
","[{'ForeName': 'Shingen', 'Initials': 'S', 'LastName': 'Misaka', 'Affiliation': 'Department of Bioregulation and Pharmacological Medicine, School of Medicine, Fukushima Medical University School of Medicine, Fukushima, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Abe', 'Affiliation': 'Department of Bioregulation and Pharmacological Medicine, School of Medicine, Fukushima Medical University School of Medicine, Fukushima, Japan.'}, {'ForeName': 'Tomoyuki', 'Initials': 'T', 'LastName': 'Ono', 'Affiliation': 'Department of Bioregulation and Pharmacological Medicine, School of Medicine, Fukushima Medical University School of Medicine, Fukushima, Japan.'}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Ono', 'Affiliation': 'Department of Bioregulation and Pharmacological Medicine, School of Medicine, Fukushima Medical University School of Medicine, Fukushima, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Ogata', 'Affiliation': 'Department of Bioregulation and Pharmacological Medicine, School of Medicine, Fukushima Medical University School of Medicine, Fukushima, Japan.'}, {'ForeName': 'Itaru', 'Initials': 'I', 'LastName': 'Miura', 'Affiliation': 'Department of Neuropsychiatry, School of Medicine, Fukushima Medical University School of Medicine, Fukushima, Japan.'}, {'ForeName': 'Yayoi', 'Initials': 'Y', 'LastName': 'Shikama', 'Affiliation': 'Centre for Medical Education and Career Development, School of Medicine, Fukushima Medical University School of Medicine, Fukushima, Japan.'}, {'ForeName': 'Martin F', 'Initials': 'MF', 'LastName': 'Fromm', 'Affiliation': 'Institute of Experimental and Clinical Pharmacology and Toxicology, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Hirooki', 'Initials': 'H', 'LastName': 'Yabe', 'Affiliation': 'Department of Neuropsychiatry, School of Medicine, Fukushima Medical University School of Medicine, Fukushima, Japan.'}, {'ForeName': 'Kenju', 'Initials': 'K', 'LastName': 'Shimomura', 'Affiliation': 'Department of Bioregulation and Pharmacological Medicine, School of Medicine, Fukushima Medical University School of Medicine, Fukushima, Japan.'}]",British journal of clinical pharmacology,['10.1111/bcp.14315']
158,32114617,Effect of Delirium on Physical Function in Noncardiac Thoracic Surgery Patients.,"BACKGROUND


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


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


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


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


Postoperative delirium was not associated with change in muscle strength. Follow-up studies using other muscle measures may be needed.",2020,"More patients in the delirium group had a change in Katz score (13% vs 0%, P = .04).
","['Exclusion criteria were history of schizophrenia, Parkinson disease, dementia, alcohol abuse, or neuroleptic malignant syndrome', 'patients undergoing noncardiac thoracic surgery', 'Seventy-three patients were included in the analysis', 'English-speaking adults aged 18 years or older who were undergoing major noncardiac thoracic surgery', 'Noncardiac Thoracic Surgery Patients']","['Delirium', 'delirium', 'levodopa or cholinesterase inhibitors', 'haloperidol']","['MRC-SS and Katz score by delirium status', 'MRC-SS', 'modified MRC-SS and functional independence', 'muscle strength', 'Katz scale of activities of daily living', 'Katz score', 'Delirium', 'Median (interquartile range) MRC-SS and Katz score', 'change in Medical Research Council sum score (MRC-SS) by delirium status', 'muscle strength and functional independence']","[{'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0455502', 'cui_str': 'H/O: schizophrenia'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0085762', 'cui_str': 'Alcohol abuse (disorder)'}, {'cui': 'C1869046', 'cui_str': 'Neuroleptic malignant syndrome (SMQ)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0039986', 'cui_str': 'Thoracic Surgery'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]","[{'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C4521309', 'cui_str': 'Cholinesterase inhibitor (disposition)'}, {'cui': 'C0018546', 'cui_str': 'Haloperidol'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0222045'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0079816', 'cui_str': 'Medical Research'}]",73.0,0.148846,"More patients in the delirium group had a change in Katz score (13% vs 0%, P = .04).
","[{'ForeName': 'Sikandar H', 'Initials': 'SH', 'LastName': 'Khan', 'Affiliation': 'Sikandar H. Khan is an assistant research professor.'}, {'ForeName': 'Chenjia', 'Initials': 'C', 'LastName': 'Xu', 'Affiliation': 'Chenjia Xu is a doctoral student.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Sophia Wang is an assistant clinical professor, Department of Psychiatry, Indiana University School of Medicine.'}, {'ForeName': 'Sujuan', 'Initials': 'S', 'LastName': 'Gao', 'Affiliation': 'Sujuan Gao is a professor, Department of Biostatistics, Indiana University School of Medicine.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Lasiter', 'Affiliation': 'Sue Lasiter is an associate professor, University of Missouri-Kansas City School of Nursing and Health Studies, Kansas City, Missouri.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Kesler', 'Affiliation': 'Kenneth Kesler is a professor, Department of Cardiothoracic Surgery, Indiana University School of Medicine.'}, {'ForeName': 'Babar A', 'Initials': 'BA', 'LastName': 'Khan', 'Affiliation': 'Babar A. Khan is an associate professor, Division of Pulmonary, Critical Care, Sleep and Occupational Medicine, Department of Medicine, Indiana University School of Medicine, and IU Center for Aging Research, Regenstrief Institute, Indianapolis, Indiana.'}]","American journal of critical care : an official publication, American Association of Critical-Care Nurses",['10.4037/ajcc2020579']
159,31042696,Effects of MDMA on attention to positive social cues and pleasantness of affective touch.,"The psychostimulant drug ±3,4-methylenedioxymethamphetamine (MDMA) reportedly produces distinctive feelings of empathy and closeness with others. MDMA increases social behavior in animal models and has shown promise in psychiatric disorders, such as autism spectrum disorder (ASD) and post-traumatic stress disorder (PTSD). How it produces these prosocial effects is not known. This behavioral and psychophysiological study examined the effects of MDMA, compared with the prototypical stimulant methamphetamine (MA), on two measures of social behavior in healthy young adults: (i) responses to socially relevant, ""affective"" touch, and (ii) visual attention to emotional faces. Men and women (N = 36) attended four sessions in which they received MDMA (0.75 or 1.5 mg/kg), MA (20 mg), or a placebo in randomized order under double-blind conditions. Responses to experienced and observed affective touch (i.e., being touched or watching others being touched) were assessed using facial electromyography (EMG), a proxy of affective state. Responses to emotional faces were assessed using electrooculography (EOG) in a measure of attentional bias. Subjective ratings were also included. We hypothesized that MDMA, but not MA, would enhance the ratings of pleasantness and psychophysiological responses to affective touch and increase attentional bias toward positive facial expressions. Consistent with this, we found that MDMA, but not MA, selectively enhanced ratings of pleasantness of experienced affective touch. Neither drug altered the ratings of pleasantness of observed touch. On the EOG measure of attentional bias, MDMA, but not MA, increased attention toward happy faces. These results provide new evidence that MDMA can enhance the experience of positive social interactions; in this case, pleasantness of physical touch and attentional bias toward positive facial expressions. The findings are consistent with evidence that the prosocial effects are unique to MDMA relative to another stimulant. Understanding the behavioral and neurobiological processes underlying the distinctive social effects of MDMA is a key step to developing the drug for psychiatric disorders.",2019,"On the EOG measure of attentional bias, MDMA, but not MA, increased attention toward happy faces.","['Men and women (N\u2009=\u200936) attended four sessions in which they received', 'healthy young adults']","['placebo', 'psychostimulant drug ±3,4-methylenedioxymethamphetamine (MDMA', 'MDMA', 'electrooculography (EOG', 'MA', 'prototypical stimulant methamphetamine (MA']","['ratings of pleasantness and psychophysiological responses to affective touch and increase attentional bias toward positive facial expressions', 'positive social cues and pleasantness of affective touch', 'Subjective ratings', 'ratings of pleasantness of observed touch', 'attention toward happy faces']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0304403', 'cui_str': 'Psychostimulant'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0115471', 'cui_str': 'MDMA'}, {'cui': 'C0013854', 'cui_str': 'EOG'}, {'cui': 'C0242977', 'cui_str': 'Stimulants, Historical'}, {'cui': 'C0025611', 'cui_str': 'metamfetamine'}]","[{'cui': 'C0152054', 'cui_str': 'Therapeutic Touch'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C4277667', 'cui_str': 'Attentional Bias'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0015457', 'cui_str': 'Facial Expression'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0018592', 'cui_str': 'Happinesses'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}]",,0.0389876,"On the EOG measure of attentional bias, MDMA, but not MA, increased attention toward happy faces.","[{'ForeName': 'Anya K', 'Initials': 'AK', 'LastName': 'Bershad', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Leah M', 'Initials': 'LM', 'LastName': 'Mayo', 'Affiliation': 'Center for Social and Affective Neuroscience, Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Kathryne', 'Initials': 'K', 'LastName': 'Van Hedger', 'Affiliation': 'Department of Clinical Neurological Sciences, University of Western Ontario, London, ON, UK.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'McGlone', 'Affiliation': 'School of Natural Sciences and Psychology, Liverpool John Moores University, Liverpool, UK.'}, {'ForeName': 'Susannah C', 'Initials': 'SC', 'LastName': 'Walker', 'Affiliation': 'School of Natural Sciences and Psychology, Liverpool John Moores University, Liverpool, UK.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'de Wit', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, Chicago, IL, USA. hdew@uchicago.edu.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0402-z']
160,31455832,Effects of deep neuromuscular blockade on the stress response during laparoscopic gastrectomy Randomized controlled trials.,"Maintaining deep neuromuscular block during surgery improves surgical space conditions. However, its effects on patient outcomes have not been well documented. We examined whether maintaining deep neuromuscular blockade during surgery could decrease the stress response compared to moderate neuromuscular blockade. Patients undergoing laparoscopic gastrectomy were randomly allocated to either the moderate (train-of-four counts of 1-2) or deep (post-tetanic counts of 1-2) neuromuscular blockade group. The primary outcome variable was the postoperative blood level of interleukin-6, and the secondary outcome variables were intraoperative or postoperative blood levels of tumor necrosis factor-α, interleukin-1β, interleukin-8, and C-reactive protein. A total of 96 patients were recruited and 88 (44 in each group) were included in the analyses. The levels of tumor necrosis factor-α and interleukin-1β measured at the end of surgery, interleukin-6 and interleukin-8 measured at 2 h postoperatively, and C-reactive protein measured at 48 h postoperatively were all significantly increased compared to the preoperative values, but there were no differences between the moderate and deep neuromuscular block groups. We found no differences in surgical stress response measured using determining levels of interleukin-6 and other mediators released between the moderate and deep neuromuscular blockade groups in patients undergoing laparoscopic gastrectomy.",2019,We found no differences in surgical stress response measured using determining levels of interleukin-6 and other mediators released between the moderate and deep neuromuscular blockade groups in patients undergoing laparoscopic gastrectomy.,"['Patients undergoing laparoscopic gastrectomy', 'A total of 96 patients were recruited and 88 (44 in each group) were included in the analyses', 'patients undergoing laparoscopic gastrectomy']","['deep neuromuscular blockade', 'neuromuscular blockade group']","['surgical stress response', 'postoperative blood level of interleukin-6', 'levels of tumor necrosis factor-α and interleukin-1β measured at the end of surgery, interleukin-6 and interleukin-8 measured at 2\u2009h postoperatively, and C-reactive protein', 'stress response', 'intraoperative or postoperative blood levels of tumor necrosis factor-α, interleukin-1β, interleukin-8, and C-reactive protein']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0017118', 'cui_str': 'Gastrectomy'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0235062', 'cui_str': 'Neuromuscular Block'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0005768'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'Tumor Necrosis Factors'}, {'cui': 'C0021764', 'cui_str': 'Interleukins'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}]",96.0,0.306369,We found no differences in surgical stress response measured using determining levels of interleukin-6 and other mediators released between the moderate and deep neuromuscular blockade groups in patients undergoing laparoscopic gastrectomy.,"[{'ForeName': 'Bon-Wook', 'Initials': 'BW', 'LastName': 'Koo', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.'}, {'ForeName': 'Ah-Young', 'Initials': 'AY', 'LastName': 'Oh', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Bundang Hospital, Seongnam, Korea. ohahyoung@hanmail.net.'}, {'ForeName': 'Jung-Hee', 'Initials': 'JH', 'LastName': 'Ryu', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.'}, {'ForeName': 'Yea-Ji', 'Initials': 'YJ', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.'}, {'ForeName': 'Ji-Won', 'Initials': 'JW', 'LastName': 'Han', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.'}, {'ForeName': 'Sun-Woo', 'Initials': 'SW', 'LastName': 'Nam', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.'}, {'ForeName': 'Do-Jung', 'Initials': 'DJ', 'LastName': 'Park', 'Affiliation': 'Department of Surgery, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Kwang-Suk', 'Initials': 'KS', 'LastName': 'Seo', 'Affiliation': 'Department of Dental Anesthesiology, Seoul National University Dental Hospital, Seoul, Korea.'}]",Scientific reports,['10.1038/s41598-019-48919-2']
161,32318647,Neurokinin 3 Receptor Antagonists Do Not Increase FSH or Estradiol Secretion in Menopausal Women.,"Background


Neurokinin 3 receptor (NK3R) antagonism is a promising novel treatment for menopausal flashes. However, to avoid adverse hormonal effects it is clinically important to first confirm whether gonadotropin and estradiol concentrations change as a result of their administration.
Methods


Single-center, randomized, double-blind, placebo-controlled, crossover trial of an oral NK3R antagonist (MLE4901) in 28 women aged 40 to 62 years, experiencing >7 hot flashes/24 h; some bothersome or severe (Clinicaltrials.gov, NCT02668185). Weekly serum gonadotropins and estradiol levels were measured using commercially available automated immunoassays a priori. Serum estradiol was also measured post hoc using a highly sensitive direct assay by liquid chromatography tandem mass spectrometry. Hormone levels were compared by the paired sample  t  tests or by the Wilcoxon matched-pairs signed rank test, as appropriate for the distribution of the data.
Results


Mean (standard deviation) serum follicle-stimulating hormone (FSH) concentration was not significantly increased when taking MLE4901 (72.07 ± 19.81 IU/L) compared to placebo (70.03 ± 19.56 IU/L),  P  = .26. Serum estradiol was also not significantly altered, irrespective of which assay method was used (median interquartile range of serum estradiol by immunoassay: placebo 36 ± 3 pmol/L, MLE4901 36 ± 1 pmol/L,  P  = .21; median serum highly sensitive estradiol: placebo 12 ± 16 pmol/L, MLE4901 13 ± 15 pmol/L,  P  = .70). However, mean (standard deviation) serum luteinizing hormone concentration significantly decreased with MLE4901 (27.63 ± 9.76 IU/L) compared to placebo (30.26 ± 9.75 IU/L),  P  = .0024.
Implication


NK3R antagonists do not increase serum estradiol or FSH despite their reduction in hot flashes. This is clinically significant and highly reassuring for women who have a contraindication to conventional hormone therapy such as prior/existing breast cancer and/or thromboembolism.",2020,"Mean (standard deviation) serum follicle-stimulating hormone (FSH) concentration was not significantly increased when taking MLE4901 (72.07 ± 19.81 IU/L) compared to placebo (70.03 ± 19.56 IU/L),  P  = .26.","['women who have a contraindication to conventional hormone therapy such as prior/existing breast cancer and/or thromboembolism', '28 women aged 40 to 62 years, experiencing >7 hot flashes/24 h; some bothersome or severe (Clinicaltrials.gov, NCT02668185', 'Menopausal Women']","['oral NK3R antagonist (MLE4901', '\n\n\nNeurokinin 3 receptor (NK3R) antagonism', 'placebo']","['Serum estradiol', 'Weekly serum gonadotropins and estradiol levels', 'Mean (standard deviation) serum follicle-stimulating hormone (FSH) concentration', 'mean (standard deviation) serum luteinizing hormone concentration', 'serum estradiol or FSH', 'FSH or Estradiol Secretion', 'Hormone levels']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0444519', 'cui_str': 'Hot'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0068603', 'cui_str': 'Neuromedin K Receptor'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0474672', 'cui_str': 'Serum estradiol measurement'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0018061', 'cui_str': 'Gonadotropin'}, {'cui': 'C0337434', 'cui_str': 'Estradiol measurement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0857927', 'cui_str': 'Serum follicle stimulating hormone'}, {'cui': 'C0202022', 'cui_str': 'Follicle stimulating hormone measurement'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0018120', 'cui_str': 'Ovarian follicle structure'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C1287355', 'cui_str': 'Hormone level - finding'}]",28.0,0.318722,"Mean (standard deviation) serum follicle-stimulating hormone (FSH) concentration was not significantly increased when taking MLE4901 (72.07 ± 19.81 IU/L) compared to placebo (70.03 ± 19.56 IU/L),  P  = .26.","[{'ForeName': 'Julia K', 'Initials': 'JK', 'LastName': 'Prague', 'Affiliation': 'Section of Endocrinology & Investigative Medicine, Imperial College, London, UK.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Abbara', 'Affiliation': 'Section of Endocrinology & Investigative Medicine, Imperial College, London, UK.'}, {'ForeName': 'Alexander N', 'Initials': 'AN', 'LastName': 'Comninos', 'Affiliation': 'Section of Endocrinology & Investigative Medicine, Imperial College, London, UK.'}, {'ForeName': 'Channa N', 'Initials': 'CN', 'LastName': 'Jayasena', 'Affiliation': 'Section of Endocrinology & Investigative Medicine, Imperial College, London, UK.'}, {'ForeName': 'Claire E', 'Initials': 'CE', 'LastName': 'Higham', 'Affiliation': 'Department of Endocrinology, The Christie NHS Foundation Trust, University of Manchester, Manchester Academic Health Science Centre, Manchester, UK.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Adaway', 'Affiliation': 'Biochemistry Department, Wythenshawe Hospital, Wythenshawe, UK.'}, {'ForeName': 'Brian G', 'Initials': 'BG', 'LastName': 'Keevil', 'Affiliation': 'Biochemistry Department, Wythenshawe Hospital, Wythenshawe, UK.'}, {'ForeName': 'Johannes D', 'Initials': 'JD', 'LastName': 'Veldhuis', 'Affiliation': 'Mayo Clinic, Rochester, MN, UK.'}, {'ForeName': 'Waljit S', 'Initials': 'WS', 'LastName': 'Dhillo', 'Affiliation': 'Section of Endocrinology & Investigative Medicine, Imperial College, London, UK.'}]",Journal of the Endocrine Society,['10.1210/jendso/bvz009']
162,32323119,Testing the cross-stressor hypothesis under real-world conditions: exercise as a moderator of the association between momentary anxiety and cardiovascular responses.,"The cross-stressor adaptation hypothesis of exercise training has not been investigated under real-life conditions. Using ecological momentary assessment, we tested whether usual exercise level moderates the relationship of self-reported anxiety to concurrent ambulatory heart rate (HR) and systolic/diastolic blood pressure (SBP/DBP). Participants (N = 832) completed 24-h ambulatory monitoring of HR/BP, using a brachial BP cuff that took readings at 28-min intervals. Anxiety levels were concurrently reported on a visual analog scale (VAS) using a Palm Pilot. Usual exercise behavior was assessed by a self-report questionnaire. Random coefficients linear regression models predicting momentary HR/BP readings from time-matched anxiety scores were estimated, yielding the average within-person effect (slope) of anxiety. The interaction of exercise level (i.e., no weekly exercise, 1-149, and ≥ 150 min/week; a between-person factor) with anxiety was added to the model in order to estimate the average anxiety slope for participants in each exercise category. The relationship of HR/BP to anxiety did not differ significantly among exercise categories, hence not providing evidence for the cross-stressor hypothesis. In an exploratory analysis of the difference in HR/BP between occasions when anxiety was in the top versus bottom person-specific quintiles of responses, the difference in HR (but not SBP or DBP) varied significantly by exercise level (F(2,625) = 4.92, p = 0.008). Though our pre-specified analysis did not support the hypothesis, we provide some post hoc evidence supporting the cross-stressor hypothesis of exercise training for the HR response to anxiety.",2020,"The relationship of HR/BP to anxiety did not differ significantly among exercise categories, hence not providing evidence for the cross-stressor hypothesis.",[],['exercise training'],"['visual analog scale (VAS', 'HR/BP to anxiety', 'Usual exercise behavior', '24-h ambulatory monitoring of HR/BP, using a brachial BP cuff that took readings', 'HR/BP', 'Anxiety levels', 'usual exercise level moderates the relationship of self-reported anxiety to concurrent ambulatory heart rate (HR) and systolic/diastolic blood pressure (SBP/DBP']",[],"[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0242882', 'cui_str': 'Ambulatory Monitoring'}, {'cui': 'C0445456', 'cui_str': 'Brachial'}, {'cui': 'C0441107', 'cui_str': 'Device cuff'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}]",,0.0208932,"The relationship of HR/BP to anxiety did not differ significantly among exercise categories, hence not providing evidence for the cross-stressor hypothesis.","[{'ForeName': 'Ipek', 'Initials': 'I', 'LastName': 'Ensari', 'Affiliation': 'Data Science Institute, Columbia University, 475 Riverside Dr, Room 320, New York, NY, 10115, USA. ie2145@columbia.edu.'}, {'ForeName': 'Joseph E', 'Initials': 'JE', 'LastName': 'Schwartz', 'Affiliation': 'Center for Behavioral Cardiovascular Health, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Edmondson', 'Affiliation': 'Center for Behavioral Cardiovascular Health, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Andrea T', 'Initials': 'AT', 'LastName': 'Duran', 'Affiliation': 'Center for Behavioral Cardiovascular Health, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Daichi', 'Initials': 'D', 'LastName': 'Shimbo', 'Affiliation': 'Center for Behavioral Cardiovascular Health, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Keith M', 'Initials': 'KM', 'LastName': 'Diaz', 'Affiliation': 'Center for Behavioral Cardiovascular Health, Columbia University Irving Medical Center, New York, NY, USA.'}]",Journal of behavioral medicine,['10.1007/s10865-020-00155-0']
163,32309882,"The effect of repetitive transcranial magnetic stimulation on food choice-related self-control in patients with severe, enduring anorexia nervosa.","OBJECTIVE


Individuals with anorexia nervosa (AN) pursue low-fat, low-calorie diets even when in a state of emaciation. These maladaptive food choices may involve fronto-limbic circuitry associated with cognitive control, habit, and reward. We assessed whether high-frequency repetitive transcranial magnetic stimulation (rTMS) to the left dorsolateral prefrontal cortex (DLPFC) influenced food-related choice behavior in patients with severe, enduring (SE)-AN.
METHOD


Thirty-four females with SE-AN completed a Food Choice Task before and after 20 sessions of real or sham rTMS treatment and at a 4-month follow-up. During the task, participants rated high- and low-fat food items for healthiness and tastiness and then made a series of choices between a neutral-rated food and high- and low-fat foods. Outcomes included the proportion of high-fat and self-controlled choices made. A comparison group of 30 healthy women completed the task at baseline only.
RESULTS


Baseline data were consistent with previous findings: relative to healthy controls, SE-AN participants showed a preference for low-fat foods and exercised self-control on a greater proportion of trials. There was no significant effect of rTMS treatment nor time on food choices related to fat content. However, among SE-AN participants who received real rTMS, there was a decrease in self-controlled food choices at post-treatment, relative to baseline. Specifically, there was an increase in the selection of tasty-unhealthy foods.
DISCUSSION


In SE-AN, rTMS may promote more flexibility in relation to food choice. This may result from neuroplastic changes in the DLPFC and/or in associated brain areas.",2020,"However, among SE-AN participants who received real rTMS, there was a decrease in self-controlled food choices at post-treatment, relative to baseline.","['30 healthy women completed the task at baseline only', 'patients with severe, enduring (SE)-AN.\nMETHOD\n\n\nThirty-four females with SE-AN completed a', 'patients with severe, enduring anorexia nervosa', 'Individuals with anorexia nervosa (AN']","['repetitive transcranial magnetic stimulation', 'high-frequency repetitive transcranial magnetic stimulation (rTMS', 'real rTMS', 'Food Choice Task before and after 20 sessions of real or sham rTMS', 'rTMS']","['self-controlled food choices', 'proportion of high-fat and self-controlled choices made']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0003125', 'cui_str': 'Anorexia nervosa'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0684274', 'cui_str': 'Self-control'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015677', 'cui_str': 'Fat'}]",34.0,0.0323544,"However, among SE-AN participants who received real rTMS, there was a decrease in self-controlled food choices at post-treatment, relative to baseline.","[{'ForeName': 'Bethan', 'Initials': 'B', 'LastName': 'Dalton', 'Affiliation': ""Section of Eating Disorders, Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Foerde', 'Affiliation': 'Department of Psychiatry, Columbia University Irving Medical Center and New York State Psychiatric Institute, New York City, New York, USA.'}, {'ForeName': 'Savani', 'Initials': 'S', 'LastName': 'Bartholdy', 'Affiliation': ""Section of Eating Disorders, Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'McClelland', 'Affiliation': ""Section of Eating Disorders, Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Kekic', 'Affiliation': ""Section of Eating Disorders, Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Luiza', 'Initials': 'L', 'LastName': 'Grycuk', 'Affiliation': ""Section of Eating Disorders, Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Iain C', 'Initials': 'IC', 'LastName': 'Campbell', 'Affiliation': ""Section of Eating Disorders, Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Schmidt', 'Affiliation': ""Section of Eating Disorders, Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Joanna E', 'Initials': 'JE', 'LastName': 'Steinglass', 'Affiliation': 'Department of Psychiatry, Columbia University Irving Medical Center and New York State Psychiatric Institute, New York City, New York, USA.'}]",The International journal of eating disorders,['10.1002/eat.23267']
164,31357206,Pharmacological mechanisms of interhemispheric signal propagation: a TMS-EEG study.,"Interhemispheric connections across the corpus callosum have a predominantly inhibitory effect. Previous electrophysiology studies imply that local inhibitory circuits are responsible for inducing transcallosal inhibition, likely through inhibitory GABA B -mediated neurotransmission. We investigated the neurochemical mechanisms involved in interhemispheric connectivity by measuring transcranial magnetic stimulation (TMS)-induced interhemispheric signal propagation (ISP) in the motor cortex and dorsolateral prefrontal cortex (DLPFC) with electroencephalography (EEG) recordings under the pharmacological effects of baclofen, L-DOPA, dextromethorphan, and rivastigmine. We hypothesized that for both stimulated regions, GABA B  receptor agonist baclofen would decrease ISP when compared against baseline while drugs that target other neurotransmitter systems (dopaminergic, acetylcholinergic, and glutamatergic systems) would have no effect on ISP. Twelve right-handed healthy volunteers completed this study and underwent TMS across five sessions in a randomized order. In the motor cortex, participants showed a significant decrease in ISP under baclofen, but not in the other drug conditions. There were no drug-induced changes in ISP in the DLPFC and baseline ISP did not differ across experimental sessions for both brain regions. Together, our results suggest that the inhibitory effects observed with interhemispheric signal transmission are mediated by a population of interneurons involving GABA B  receptor neurotransmission. Inhibitory mechanisms of ISP may be more salient for motor-related functions in the motor cortex than for cognitive control in the DLPFC. These findings are a fundamental step in advancing our understanding of interhemispheric connectivity and may be used to identify treatments for disorders in which transcallosal transmission is dysfunctional.",2020,"In the motor cortex, participants showed a significant decrease in ISP under baclofen, but not in the other drug conditions.",['Twelve right-handed healthy volunteers'],"['baclofen, L-DOPA, dextromethorphan, and rivastigmine', 'TMS', 'transcranial magnetic stimulation (TMS)-induced interhemispheric signal propagation (ISP']","['ISP under baclofen', 'ISP']","[{'cui': 'C0344333', 'cui_str': 'Right handed (finding)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0004609', 'cui_str': 'Baclofen'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0011816', 'cui_str': 'Dextromethorphan'}, {'cui': 'C0649350', 'cui_str': 'rivastigmine'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation (procedure)'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}]","[{'cui': 'C0004609', 'cui_str': 'Baclofen'}]",12.0,0.0545946,"In the motor cortex, participants showed a significant decrease in ISP under baclofen, but not in the other drug conditions.","[{'ForeName': 'Jeanette', 'Initials': 'J', 'LastName': 'Hui', 'Affiliation': 'Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Zomorrodi', 'Affiliation': 'Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Pantelis', 'Initials': 'P', 'LastName': 'Lioumis', 'Affiliation': 'Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Bahar', 'Initials': 'B', 'LastName': 'Salavati', 'Affiliation': 'Institute of Medical Science, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Tarek K', 'Initials': 'TK', 'LastName': 'Rajji', 'Affiliation': 'Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Chen', 'Affiliation': 'Institute of Medical Science, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Blumberger', 'Affiliation': 'Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Zafiris J', 'Initials': 'ZJ', 'LastName': 'Daskalakis', 'Affiliation': 'Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health, Toronto, ON, Canada. Jeff.Daskalakis@camh.ca.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0468-7']
165,30926955,"Effects of liraglutide on appetite, food preoccupation, and food liking: results of a randomized controlled trial.","BACKGROUND


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


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


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


Consistent with short-term studies, IBT-liraglutide participants reported greater improvements in hunger, fullness, and food preoccupation than those assigned to IBT-alone. Differences in appetite persisted for 24 weeks but were not maintained at week 52, despite the relatively greater weight losses in the liraglutide-treated participants at the trial's end.",2020,"Multi-component participants reported reduced liking of meals relative to the IBT-alone and IBT-liraglutide groups through weeks 40 and 52, respectively.","['113 adults with obesity (76.1% female, 55.8% white, BMI\u2009=\u200938.8\u2009±\u20094.8\u2009kg/m 2 ) who participated in a 52-week trial']","['intensive behavioral therapy alone (IBT-alone), IBT with liraglutide 3.0\u2009mg/day (IBT-liraglutide), or IBT-liraglutide combined with a 12-week meal replacement diet (Multi-component', 'IBT-alone, IBT-liraglutide', 'IBT-alone and Multi-component', 'IBT-liraglutide', 'liraglutide']","['hunger, fullness, and food preoccupation', 'liking of meals relative', 'hunger, fullness after meals, liking of meals, and food preoccupation', 'fullness', 'weight losses', 'food preoccupation', 'appetite', 'visual analogue scales', 'appetite, food preoccupation, and food liking']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C4517765', 'cui_str': '4.8 (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0004933', 'cui_str': 'Behavior Modification'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}]","[{'cui': 'C0020175', 'cui_str': 'Hunger'}, {'cui': 'C0439650', 'cui_str': 'Fullness (qualifier value)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0549165', 'cui_str': 'Preoccupation with ideas'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",113.0,0.0597185,"Multi-component participants reported reduced liking of meals relative to the IBT-alone and IBT-liraglutide groups through weeks 40 and 52, respectively.","[{'ForeName': 'Jena Shaw', 'Initials': 'JS', 'LastName': 'Tronieri', 'Affiliation': 'Department of Psychiatry, Center for Weight and Eating Disorders, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA. jena.tronieri@pennmedicine.upenn.edu.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Wadden', 'Affiliation': 'Department of Psychiatry, Center for Weight and Eating Disorders, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Walsh', 'Affiliation': 'Department of Psychiatry, Center for Weight and Eating Disorders, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Robert I', 'Initials': 'RI', 'LastName': 'Berkowitz', 'Affiliation': 'Department of Psychiatry, Center for Weight and Eating Disorders, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Naji', 'Initials': 'N', 'LastName': 'Alamuddin', 'Affiliation': 'Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Gruber', 'Affiliation': 'Department of Psychiatry, Center for Weight and Eating Disorders, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Leonard', 'Affiliation': 'Department of Psychiatry, Center for Weight and Eating Disorders, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Zayna M', 'Initials': 'ZM', 'LastName': 'Bakizada', 'Affiliation': 'Department of Psychiatry, Center for Weight and Eating Disorders, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Ariana M', 'Initials': 'AM', 'LastName': 'Chao', 'Affiliation': 'Department of Psychiatry, Center for Weight and Eating Disorders, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}]",International journal of obesity (2005),['10.1038/s41366-019-0348-6']
166,32282044,Effects of a Telehealth Early Palliative Care Intervention for Family Caregivers of Persons With Advanced Heart Failure: The ENABLE CHF-PC Randomized Clinical Trial.,"Importance


Family caregivers of persons with advanced heart failure perform numerous daily tasks to assist their relatives and are at high risk for distress and poor quality of life.
Objective


To determine the effect of a nurse-led palliative care telehealth intervention (Educate, Nurture, Advise, Before Life Ends Comprehensive Heart Failure for Patients and Caregivers [ENABLE CHF-PC]) on quality of life and mood of family caregivers of persons with New York Heart Association Class III/IV heart failure over 16 weeks.
Design, Setting, and Participants


This single-blind randomized clinical trial enrolled caregivers aged 18 years and older who self-identified as an unpaid close friend or family member who knew the patient well and who was involved with their day-to-day medical care. Participants were recruited from outpatient heart failure clinics at a large academic tertiary care medical center and a Veterans Affairs medical center from August 2016 to October 2018.
Intervention


Four weekly psychosocial and problem-solving support telephonic sessions lasting between 20 and 60 minutes facilitated by a trained nurse coach plus monthly follow-up for 48 weeks. The usual care group received no additional intervention.
Main Outcomes and Measures


The primary outcomes were quality of life (measured using the Bakas Caregiver Outcomes Scale), mood (anxiety and/or depressive symptoms measured using the Hospital Anxiety and Depression Scale), and burden (measured using the Montgomery-Borgatta Caregiver Burden scales) over 16 weeks. Secondary outcomes were global health (measured using the PROMIS Global Health instrument) and positive aspects of caregiving.
Results


A total of 158 family caregivers were randomized, 82 to the intervention and 76 to usual care. The mean (SD) age was 57.9 (11.6) years, 135 (85.4%) were female, 82 (51.9%) were African American, and 103 (65.2%) were the patient's spouse or partner. At week 16, the mean (SE) Bakas Caregiver Outcomes Scale score was 66.9 (2.1) in the intervention group and 63.9 (1.7) in the usual care group; over 16 weeks, the mean (SE) Bakas Caregiver Outcomes Scale score improved 0.7 (1.7) points in the intervention group and 1.1 (1.6) points in the usual care group (difference, -0.4; 95% CI, -5.1 to 4.3; Cohen d = -0.03). At week 16, no relevant between-group differences were observed between the intervention and usual care groups for the Hospital Anxiety and Depression Scale anxiety measure (mean [SE] improvement from baseline, 0.3 [0.3] vs 0.4 [0.3]; difference, -0.1 [0.5]; d = -0.02) or depression measure (mean [SE] improvement from baseline, -0.2 [0.4] vs -0.3 [0.3]; difference, 0.1 [0.5]; d = 0.03). No between-group differences were observed in the Montgomery-Borgatta Caregiver Burden scales (d range, -0.18 to 0.0). Differences in secondary outcomes were also not significant (d range, -0.22 to 0.0).
Conclusions and Relevance


This 2-site randomized clinical trial of a telehealth intervention for family caregivers of patients with advanced heart failure, more than half of whom were African American and most of whom were not distressed at baseline, did not demonstrate clinically better quality of life, mood, or burden compared with usual care over 16 weeks. Future interventions should target distressed caregivers and assess caregiver effects on patient outcomes.
Trial Registration


ClinicalTrials.gov Identifier: NCT02505425.",2020,"At week 16, no relevant between-group differences were observed between the intervention and usual care groups for the Hospital Anxiety and Depression Scale anxiety measure (mean [SE] improvement from baseline, 0.3 [0.3] vs 0.4 [0.3]; difference, -0.1 [0.5]; d = -0.02) or depression measure (mean [SE] improvement from baseline, -0.2","['Importance\n\n\nFamily caregivers of persons with advanced heart failure', ""The mean (SD) age was 57.9 (11.6) years, 135 (85.4%) were female, 82 (51.9%) were African American, and 103 (65.2%) were the patient's spouse or partner"", 'family caregivers of patients with advanced heart failure, more than half of whom were African American and most of whom were not distressed at baseline, did not demonstrate clinically better quality of life, mood, or burden compared with usual care over 16 weeks', 'caregivers aged 18 years and older who self-identified as an unpaid close friend or family member who knew the patient well and who was involved with their day-to-day medical care', 'Family Caregivers of Persons With Advanced Heart Failure', '158 family caregivers', 'Participants were recruited from outpatient heart failure clinics at a large academic tertiary care medical center and a Veterans Affairs medical center from August 2016 to October 2018', 'family caregivers of persons with New York Heart Association Class III/IV heart failure over 16 weeks']","['Telehealth Early Palliative Care Intervention', 'Intervention\n\n\nFour weekly psychosocial and problem-solving support telephonic sessions lasting between 20 and 60 minutes facilitated by a trained nurse coach plus monthly follow-up for 48 weeks', 'usual care group received no additional intervention', 'telehealth intervention', 'nurse-led palliative care telehealth intervention']","['global health (measured using the PROMIS Global Health instrument) and positive aspects of caregiving', 'Montgomery-Borgatta Caregiver Burden scales', 'mean (SE) Bakas Caregiver Outcomes Scale score', 'Hospital Anxiety and Depression Scale anxiety measure', 'quality of life (measured using the Bakas Caregiver Outcomes Scale), mood (anxiety and/or depressive symptoms measured using the Hospital Anxiety and Depression Scale), and burden (measured using the Montgomery-Borgatta Caregiver Burden scales']","[{'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4708782', 'cui_str': '11.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0162409', 'cui_str': 'Spouse'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C3887804', 'cui_str': 'Feeling upset'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0079382', 'cui_str': 'Friend'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0496675', 'cui_str': 'Medical care'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0441887', 'cui_str': 'Class 3'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0033211', 'cui_str': 'Problem solving'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C3853333', 'cui_str': 'Sixty minutes'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0023175', 'cui_str': 'Lead'}]","[{'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",158.0,0.108224,"At week 16, no relevant between-group differences were observed between the intervention and usual care groups for the Hospital Anxiety and Depression Scale anxiety measure (mean [SE] improvement from baseline, 0.3 [0.3] vs 0.4 [0.3]; difference, -0.1 [0.5]; d = -0.02) or depression measure (mean [SE] improvement from baseline, -0.2","[{'ForeName': 'J Nicholas', 'Initials': 'JN', 'LastName': 'Dionne-Odom', 'Affiliation': 'University of Alabama at Birmingham School of Nursing.'}, {'ForeName': 'Deborah B', 'Initials': 'DB', 'LastName': 'Ejem', 'Affiliation': 'University of Alabama at Birmingham School of Nursing.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Wells', 'Affiliation': 'University of Alabama at Birmingham School of Nursing.'}, {'ForeName': 'Andres', 'Initials': 'A', 'LastName': 'Azuero', 'Affiliation': 'University of Alabama at Birmingham School of Nursing.'}, {'ForeName': 'Macy L', 'Initials': 'ML', 'LastName': 'Stockdill', 'Affiliation': 'University of Alabama at Birmingham School of Nursing.'}, {'ForeName': 'Konda', 'Initials': 'K', 'LastName': 'Keebler', 'Affiliation': 'University of Alabama at Birmingham School of Nursing.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Sockwell', 'Affiliation': 'University of Alabama at Birmingham School of Nursing.'}, {'ForeName': 'Sheri', 'Initials': 'S', 'LastName': 'Tims', 'Affiliation': 'University of Alabama at Birmingham School of Nursing.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Engler', 'Affiliation': 'University of Alabama at Birmingham School of Nursing.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Kvale', 'Affiliation': 'Department of Medicine, Dell Medical School, The University of Texas at Austin.'}, {'ForeName': 'Raegan W', 'Initials': 'RW', 'LastName': 'Durant', 'Affiliation': 'Division of Preventive Medicine, Department of Medicine, University of Alabama at Birmingham.'}, {'ForeName': 'Rodney O', 'Initials': 'RO', 'LastName': 'Tucker', 'Affiliation': 'Center for Palliative and Supportive Care, Division of Gerontology, Geriatrics, and Palliative Care, Department of Medicine, University of Alabama at Birmingham.'}, {'ForeName': 'Kathryn L', 'Initials': 'KL', 'LastName': 'Burgio', 'Affiliation': 'Birmingham Veterans Affairs Medical Center, Birmingham, Alabama.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Tallaj', 'Affiliation': 'Division of Cardiovascular Diseases, Department of Medicine, University of Alabama at Birmingham.'}, {'ForeName': 'Salpy V', 'Initials': 'SV', 'LastName': 'Pamboukian', 'Affiliation': 'Division of Cardiovascular Diseases, Department of Medicine, University of Alabama at Birmingham.'}, {'ForeName': 'Keith M', 'Initials': 'KM', 'LastName': 'Swetz', 'Affiliation': 'Center for Palliative and Supportive Care, Division of Gerontology, Geriatrics, and Palliative Care, Department of Medicine, University of Alabama at Birmingham.'}, {'ForeName': 'Marie A', 'Initials': 'MA', 'LastName': 'Bakitas', 'Affiliation': 'University of Alabama at Birmingham School of Nursing.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.2583']
167,32286659,Effects of a Tailored Brief Behavioral Therapy Application on Insomnia Severity and Social Disabilities Among Workers With Insomnia in Japan: A Randomized Clinical Trial.,"Importance


According to the stepped-care model, there is a medium to large effect size for using cognitive behavioral therapy for insomnia that is delivered digitally, such as a smartphone application. However, it has been reported that studies using fully automated cognitive behavioral therapy for insomnia applications without expert support have high dropout rates.
Objective


To examine the effects of using a fully automated and individually tailored brief behavior therapy for insomnia (BBTI) applications for 2 weeks on insomnia-related symptoms, social disabilities, and work productivity among workers with insomnia in Japan.
Design, Setting, and Participants


This intent-to-treat prospective parallel-group randomized clinical trial included participants 20 years or older with Insomnia Severity Index (ISI) scores of 8 or higher. Participants were recruited via internet advertisements and workplace flyers and randomized to tailored BBTI, standard BBTI, self-monitoring with sleep diaries, or a waiting list control group. The study was conducted from September 21, 2017, to February 23, 2018. Data were analyzed from February 24, 2018, to February 22, 2019.
Interventions


A personalized BBTI and standard BBTI intervention, both of which included sleep scheduling, relaxation, sleep hygiene, and sleep diaries, administered via smartphone application.
Main Outcomes and Measures


Primary outcomes were insomnia severity, measured using the Japanese version of the Insomnia Severity Index, and social disabilities, measured using the Japanese version of the Sheehan Disability Scale. Secondary outcomes were dysfunctional beliefs, sleep reactivity, and work productivity. All measures were taken before and after the intervention and at 1-month and 3-month follow-ups.
Results


A total of 92 participants (mean [SD] age, 42.7 [11.5] years; 60 [65%] men) were randomized and included in analysis, with 24 participants assigned to tailored BBTI, 23 participants assigned to standard BBTI, 23 participants assigned to self-monitoring, and 22 participants assigned to the waiting list control group. At baseline, there were no significant differences among groups on any demographic characteristics or outcome measures. The results of the intent-to-treat analysis showed an interaction effect for all outcome measures. Compared with the waiting list control group, the BBTI interventions were more effective for reduction of insomnia severity (tailored BBTI: Hedges g = -1.64 [95% CI, -2.32 to -0.96]; P < .001; standard BBTI: g = -1.28 [95% CI, -1.93 to -0.63]; P < .001), social disabilities relating to social life (tailored BBTI: g = -1.33 [95% CI, -1.97 to -0.68]; P < .001; standard BBTI: g = -0.84 [95% CI, -1.46 to -0.22]; P = .009), and dysfunctional beliefs (tailored BBTI: g = -1.17 [95% CI, -1.80 to -0.54]; P < .001; standard BBTI: g = -0.84 [95% CI, -1.46 to -0.23]; P = .02) at the 3-month follow-up. Tailored BBTI quickly reduced insomnia severity (1-month follow-up: g = -0.85 [95% CI, -1.46 to -0.24]). Tailored BBTI was only more effective for improvement of work performance (g = -1.09 [95% CI, -1.71 to -0.46]; P = .005), social disabilities related to family life (g = -0.89 [95% CI, -1.51 to -0.28]; P = .005), and sleep reactivity (g = -1.09 [95% CI, -1.72 to -0.46]; P = .007) compared with the waiting list control group at the 3-month follow-up. The tailored BBTI led to improved worker productivity compared with standard BBTI (g = 0.94 [95% CI, 0.33 to 1.55]; P = .01) at the 3-month follow-up.
Conclusions and Relevance


These findings suggest that an application for individually tailored BBTI is an inexpensive and effective treatment for insomnia. In future research, it would be informative to investigate the reasons for dropout during the follow-up period.
Trial Registration


umin.ac.jp/ctr Identifier: UMIN000036572.",2020,"Tailored BBTI was only more effective for improvement of work performance (g = -1.09 [95% CI, -1.71 to -0.46]; P = .005), social disabilities related to family life (g = -0.89","['workers with insomnia in Japan', 'September 21, 2017, to February 23, 2018', 'Data were analyzed from February 24, 2018, to February 22, 2019', 'participants 20 years or older with Insomnia Severity Index (ISI) scores of 8 or higher', 'Participants were recruited via internet advertisements and workplace flyers and randomized to', 'Workers With Insomnia in Japan', '92 participants (mean [SD] age, 42.7 [11.5] years; 60 [65%] men']","['fully automated and individually tailored brief behavior therapy', 'waiting list control group', 'Tailored Brief Behavioral Therapy Application', 'tailored BBTI, standard BBTI, self-monitoring with sleep diaries, or a waiting list control group']","['Insomnia Severity and Social Disabilities', 'dysfunctional beliefs, sleep reactivity, and work productivity', 'insomnia severity (tailored BBTI', 'worker productivity', 'insomnia severity, measured using the Japanese version of the Insomnia Severity Index, and social disabilities, measured using the Japanese version of the Sheehan Disability Scale', 'social disabilities relating to social life (tailored BBTI', 'insomnia severity', 'work performance', 'social disabilities related to family life', 'sleep reactivity', 'dysfunctional beliefs (tailored BBTI']","[{'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517534', 'cui_str': '11.5'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}]","[{'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C4720840', 'cui_str': 'Sheehan disability scale'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C1286385', 'cui_str': 'Performance at work'}, {'cui': 'C0015608', 'cui_str': 'Family Relationship'}]",92.0,0.0727328,"Tailored BBTI was only more effective for improvement of work performance (g = -1.09 [95% CI, -1.71 to -0.46]; P = .005), social disabilities related to family life (g = -0.89","[{'ForeName': 'Isa', 'Initials': 'I', 'LastName': 'Okajima', 'Affiliation': 'Department of Psychological Counseling, Faculty of Humanities, Tokyo Kasei University, Tokyo, Japan.'}, {'ForeName': 'Jou', 'Initials': 'J', 'LastName': 'Akitomi', 'Affiliation': 'NEC Solution Innovators Ltd, Tokyo, Japan.'}, {'ForeName': 'Ikuo', 'Initials': 'I', 'LastName': 'Kajiyama', 'Affiliation': 'NEC Solution Innovators Ltd, Tokyo, Japan.'}, {'ForeName': 'Miho', 'Initials': 'M', 'LastName': 'Ishii', 'Affiliation': 'Senzoku Stress Coping Support Office, Tokyo, Japan.'}, {'ForeName': 'Hiroto', 'Initials': 'H', 'LastName': 'Murakami', 'Affiliation': 'NEC VALWAY Ltd, Tokyo, Japan.'}, {'ForeName': 'Mineko', 'Initials': 'M', 'LastName': 'Yamaguchi', 'Affiliation': 'NEC Solution Innovators Ltd, Tokyo, Japan.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.2775']
168,31723064,"Phase 2a randomized, placebo-controlled study of anti-IL-33 in peanut allergy.","BACKGROUNDIL-33, found in high levels in participants with allergic disorders, is thought to mediate allergic reactions. Etokimab, an anti-IL-33 biologic, has previously demonstrated a good safety profile and favorable pharmacodynamic properties in many clinical studies.METHODSIn this 6-week placebo-controlled phase 2a study, we evaluated the safety and the ability of a single dose of etokimab to desensitize peanut-allergic adults. Participants received either etokimab (n = 15) or blinded placebo (n = 5). Clinical tests included oral food challenges and skin prick tests at days 15 and 45. Blood samples were collected for IgE levels and measurement of ex vivo peanut-stimulated T cell cytokine production.RESULTSEfficacy measurements for active vs. placebo participants at the day 15 and 45 food challenge (tolerating a cumulative 275 mg of peanut protein, which was the food challenge outcome defined in this paper) demonstrated, respectively, 73% vs. 0% (P = 0.008) to 57% vs. 0% (ns). The etokimab group had fewer adverse events compared with placebo. IL-4, IL-5, IL-9, IL-13, and ST2 levels in CD4+ T cells were reduced in the active vs. placebo arm upon peanut-induced T cell activation (P = 0.036 for IL-13 and IL-9 at day 15), and peanut-specific IgE was reduced in active vs. placebo (P = 0.014 at day 15).CONCLUSIONThe phase 2a results suggest etokimab is safe and well tolerated and that a single dose of etokimab could have the potential to desensitize peanut-allergic participants and possibly reduce atopy-related adverse events.TRIAL REGISTRATIONClinicalTrials.gov NCT02920021.FUNDINGThis work was supported by NIH grant R01AI140134, AnaptysBio, the Hartman Vaccine Fund, and the Sean N. Parker Center for Allergy and Asthma Research at Stanford University.",2019,"The etokimab group had fewer adverse events compared with placebo. IL-4, IL-5, IL-9, IL-13, and ST2 levels in CD4+ T cells were reduced in the active vs. placebo arm upon peanut-induced T cell activation (P = 0.036 for IL-13 and IL-9 at day 15), and peanut-specific IgE was reduced in active vs. placebo (P = 0.014 at day 15).CONCLUSIONThe phase 2a results suggest etokimab is safe and well tolerated and that a single dose of etokimab could have the potential to desensitize peanut-allergic participants and possibly reduce atopy-related adverse events.","['participants with allergic disorders', 'peanut allergy', 'allergic adults']","['etokimab to desensitize peanut', 'etokimab', 'anti-IL-33', 'placebo', 'blinded placebo']","['adverse events', 'IL-4, IL-5, IL-9, IL-13, and ST2 levels in CD4+ T cells', 'oral food challenges and skin prick tests', 'T cell activation', 'safe and well tolerated']","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0559470', 'cui_str': 'Groundnut Hypersensitivity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0030736', 'cui_str': 'Peanuts'}, {'cui': 'C3540587', 'cui_str': 'IL33'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021758', 'cui_str': 'Interleukin-4'}, {'cui': 'C0021759', 'cui_str': 'Interleukin-5'}, {'cui': 'C0085424', 'cui_str': 'Interleukin-9'}, {'cui': 'C0214743', 'cui_str': 'IL13'}, {'cui': 'C0450499', 'cui_str': 'ST2 (body structure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0430561', 'cui_str': 'Prick test (procedure)'}]",,0.429833,"The etokimab group had fewer adverse events compared with placebo. IL-4, IL-5, IL-9, IL-13, and ST2 levels in CD4+ T cells were reduced in the active vs. placebo arm upon peanut-induced T cell activation (P = 0.036 for IL-13 and IL-9 at day 15), and peanut-specific IgE was reduced in active vs. placebo (P = 0.014 at day 15).CONCLUSIONThe phase 2a results suggest etokimab is safe and well tolerated and that a single dose of etokimab could have the potential to desensitize peanut-allergic participants and possibly reduce atopy-related adverse events.","[{'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Chinthrajah', 'Affiliation': 'Sean N. Parker Center for Allergy and Asthma Research at Stanford University.'}, {'ForeName': 'Shu', 'Initials': 'S', 'LastName': 'Cao', 'Affiliation': 'Sean N. Parker Center for Allergy and Asthma Research at Stanford University.'}, {'ForeName': 'Cherie', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Sean N. Parker Center for Allergy and Asthma Research at Stanford University.'}, {'ForeName': 'Shu-Chen', 'Initials': 'SC', 'LastName': 'Lyu', 'Affiliation': 'Sean N. Parker Center for Allergy and Asthma Research at Stanford University.'}, {'ForeName': 'Sayantani B', 'Initials': 'SB', 'LastName': 'Sindher', 'Affiliation': 'Sean N. Parker Center for Allergy and Asthma Research at Stanford University.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Long', 'Affiliation': 'Sean N. Parker Center for Allergy and Asthma Research at Stanford University.'}, {'ForeName': 'Vanitha', 'Initials': 'V', 'LastName': 'Sampath', 'Affiliation': 'Sean N. Parker Center for Allergy and Asthma Research at Stanford University.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Petroni', 'Affiliation': 'ASTHMA Inc., Clinical Research Center, Northwest Asthma and Allergy Center, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Londei', 'Affiliation': 'AnaptysBio Inc., San Diego, California, USA.'}, {'ForeName': 'Kari C', 'Initials': 'KC', 'LastName': 'Nadeau', 'Affiliation': 'Sean N. Parker Center for Allergy and Asthma Research at Stanford University.'}]",JCI insight,['10.1172/jci.insight.131347']
169,31728664,"A multicenter, double-blind, randomized trial on the bleeding profile of a drospirenone-only pill 4 mg over nine cycles in comparison with desogestrel 0.075 mg.","PURPOSE


A typical compliance problem in the use of traditional progestin-only pills is the irregular bleeding pattern and the strict daily intake. Desogestrel 75 mg has a 12-h missed-pill window; however, its poor cycle control limits a more common use.
METHODS


A drospirenone (DRSP)-only pill was developed to improve the bleeding profile.
SETTING


A phase III study in healthy women aged 18-45 years was performed to compare the bleeding profile and safety of a DRSP-only pill in a regime of 24 days of 4 mg of DRSP tablets followed by 4 days of placebo versus desogestrel 0.075 mg per day continuously over nine cycles.
POPULATION


A total of 858 women with 6691 drospirenone and 332 women with 2487 desogestrel treatment cycles were analyzed.
MAIN OUTCOME MEASURES


The primary end point was the proportion of women with unscheduled bleeding/spotting in each cycle from cycles 2 to 9 and cumulative in cycles 2-4 and cycles 7-9.
RESULTS


In each cycle, up to cycle 7, the proportion of women with unscheduled bleeding was statistically significantly lower in the DRSP group than in the DSG group (p = 0.0001, Chi-square test).
CONCLUSIONS


This report describes the improvement in bleeding profile of women using the new DRSP-only oral contraceptive in comparison to DSG, providing a better quality of live and adherence to the contraceptive method. EudraCT Registration Number: 2011-002396-42.",2019,"In each cycle, up to cycle 7, the proportion of women with unscheduled bleeding was statistically significantly lower in the DRSP group than in the DSG group (p = 0.0001, Chi-square test).
","['healthy women aged 18-45\xa0years', '858 women with 6691 drospirenone and 332 women with 2487 desogestrel treatment cycles were analyzed']","['DRSP-only pill', 'DRSP', 'desogestrel 0.075\xa0mg', 'DRSP tablets', 'traditional progestin-only pills', 'Desogestrel', 'placebo versus desogestrel', 'drospirenone']","['bleeding profile and safety', 'bleeding profile', 'proportion of women with unscheduled bleeding/spotting', 'proportion of women with unscheduled bleeding']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043822', 'cui_str': 'drospirenone'}, {'cui': 'C0057558', 'cui_str': 'Desogestrel'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0994475', 'cui_str': 'Pill (basic dose form)'}, {'cui': 'C1306692', 'cui_str': 'Desogestrel 0.075 MG'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0033306', 'cui_str': 'Progestins'}, {'cui': 'C0057558', 'cui_str': 'Desogestrel'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0043822', 'cui_str': 'drospirenone'}]","[{'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]",858.0,0.145873,"In each cycle, up to cycle 7, the proportion of women with unscheduled bleeding was statistically significantly lower in the DRSP group than in the DSG group (p = 0.0001, Chi-square test).
","[{'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Palacios', 'Affiliation': 'Instituto Palacios, Salud y Medicina de la Mujer, C/ Antonio Acuña, 9, 28009, Madrid, Spain.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Colli', 'Affiliation': 'Exeltis HealthCare Madrid, C/ Manuel Pombo Angulo 28, 4th Floor, 28050, Madrid, Spain.'}, {'ForeName': 'Pedro-Antonio', 'Initials': 'PA', 'LastName': 'Regidor', 'Affiliation': 'Exeltis Europe, Adalperostr. 84, 85737, Ismaning, Germany. pedro-antonio.regidor@exeltis.com.'}]",Archives of gynecology and obstetrics,['10.1007/s00404-019-05340-4']
170,31628475,Smoking Topography Characteristics During a 6-Week Trial of Very Low Nicotine Content Cigarettes in Smokers With Serious Mental Illness.,"INTRODUCTION


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


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


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


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


Given the high smoking rates among people with SMI, understanding how a nicotine-reduction policy may affect this population is critically important. When considering the smoking topography results as a whole, smokers with SMI did not engage in compensatory smoking behavior when using VLNC cigarettes during a 6-week trial. Study findings suggest that compensatory smoking is not likely to occur among smokers with SMI if nicotine content is lowered to minimally addictive levels.",2020,"There were no differences between research cigarette conditions at Week 6 for cigarette volume, puff volume, puff duration, peak flow rate, or carbon monoxide boost.
","['smokers with SMI (N=58', 'smokers with serious mental illness (SMI', 'smokers with serious mental illness', 'smokers with SMI']","['smoking very low nicotine content (VLNC) cigarettes', 'VLNC (0.4 mg nicotine/g tobacco) or normal nicotine content (NNC; 15.8 mg/g) research cigarettes for six weeks', 'nicotine content cigarettes', 'handheld smoking topography device']","['cigarette volume, puff volume, puff duration, peak flow rate, or carbon monoxide boost', 'VLNC condition smoked fewer puffs per cigarette and had shorter inter-puff intervals']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0915075', 'cui_str': 'samarium diiodide'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}]","[{'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0442811', 'cui_str': 'Very low (qualifier value)'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C4517457', 'cui_str': 'Zero point four'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C1300563', 'cui_str': 'ug/mg'}, {'cui': 'C0035168'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0220819', 'cui_str': 'devices'}]","[{'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C1533107', 'cui_str': 'Puffs'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0729283', 'cui_str': 'Peak flow rate (respiratory)'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0205388', 'cui_str': 'Few (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}]",,0.0201706,"There were no differences between research cigarette conditions at Week 6 for cigarette volume, puff volume, puff duration, peak flow rate, or carbon monoxide boost.
","[{'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'Denlinger-Apte', 'Affiliation': 'Department of Social Sciences and Health Policy, Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Eric C', 'Initials': 'EC', 'LastName': 'Donny', 'Affiliation': 'Baptist Comprehensive Cancer Center and Department of Physiology and Pharmacology, Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Bruce R', 'Initials': 'BR', 'LastName': 'Lindgren', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Rubin', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Goodwin', 'Affiliation': 'Center for Alcohol and Addiction Studies, School of Public Health, Brown University, Providence, RI.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'DeAtley', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, RI.'}, {'ForeName': 'Suzanne M', 'Initials': 'SM', 'LastName': 'Colby', 'Affiliation': 'Center for Alcohol and Addiction Studies, School of Public Health, Brown University, Providence, RI.'}, {'ForeName': 'Patricia A', 'Initials': 'PA', 'LastName': 'Cioe', 'Affiliation': 'Center for Alcohol and Addiction Studies, School of Public Health, Brown University, Providence, RI.'}, {'ForeName': 'Dorothy K', 'Initials': 'DK', 'LastName': 'Hatsukami', 'Affiliation': 'Masonic Cancer Center and Department of Psychiatry, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Jennifer W', 'Initials': 'JW', 'LastName': 'Tidey', 'Affiliation': 'Center for Alcohol and Addiction Studies, School of Public Health, Brown University, Providence, RI.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz198']
171,32229466,The Effect of Narrative on Physical Activity via Immersion During Active Video Game Play in Children: Mediation Analysis.,"BACKGROUND


Active video games (AVGs) can increase physical activity (PA) and help produce higher physiological expenditure. Animated narrative videos (NVs) possess unique immersive and motivational properties. When added to AVGs, they have been found to increase moderate-to-vigorous physical activity (MVPA) as opposed to the original no video condition. However, there is no evidence of whether that was due to the NV or the addition of an animated video to an AVG.
OBJECTIVE


This study aimed to investigate the differential effect of adding an NV versus a nonnarrative video (NNV) to an AVG on PA parameters and physiological responses and to explore the mediating role of immersion.
METHODS


A total of 22 children aged 8 to 12 years were randomly assigned to the NV or NNV condition. They were instructed to play an AVG (on Xbox Kinect) for as long as they wanted. We used accelerometers to estimate the time spent (in minutes) in MVPA. Heart rate (HR) and rate of perceived exertion (RPE) were measured before, during, and after the AVG play session. The participants then reported their experience of narrative immersion via a questionnaire.
RESULTS


The NV group had significantly higher narrative immersion (mean 3.50, SD 0.55 vs mean 2.91, SD 0.59; P=.03) and MVPA than the NNV group (mean 19.46, SD 13.31 vs mean 7.85, SD 5.83; P=.02). Narrative immersion was positively correlated with MVPA (r=0.52; P=.01) and average HR during AVG (r=0.43; P=.05). Mediation analysis indicated that narrative immersion mediated the effect of NV (NV vs NNV) on MVPA (direct effect: beta=7.51; P=.01). The indirect effect was that NV was positively correlated with the mediator variable narrative immersion (beta=.59; P=.03), which was itself marginally associated with MVPA (beta=6.95; P=.09); when narrative immersion was included in the model, the regression coefficient was attenuated.
CONCLUSIONS


AVG with added narratives elicits more narrative immersion, resulting in more minutes in MVPA. Narrative immersion served as a mediator between NV and MVPA via its elicitation of an elevated HR without increasing RPE. The inclusion of immersive narratives in AVG could be helpful for inducing MVPA, to enhance AVG engagement without additional exertion.",2020,"The NV group had significantly higher narrative immersion (mean 3.50, SD 0.55 vs mean 2.91, SD 0.59; P=.03) and MVPA than the NNV group (mean 20.11, SD 13.75 vs mean 7.85, SD 5.83; P=.02).","['22 children aged 8 to 12 years', 'Children']","['Narrative on Physical Activity via Immersion', 'Active video games (AVGs', 'NV versus a nonnarrative video (NNV', 'Animated narrative videos (NVs) possess unique immersive and motivational properties']","['MVPA', 'Narrative immersion', 'narrative immersion', 'Heart rate (HR) and rate of perceived exertion (RPE', 'physical activity (PA']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0020940', 'cui_str': 'Immersion'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0042649', 'cui_str': 'Video Games'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0871161', 'cui_str': 'Property (attribute)'}]","[{'cui': 'C0020940', 'cui_str': 'Immersion'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}, {'cui': 'C0445208', 'cui_str': 'RPE'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",22.0,0.0859879,"The NV group had significantly higher narrative immersion (mean 3.50, SD 0.55 vs mean 2.91, SD 0.59; P=.03) and MVPA than the NNV group (mean 20.11, SD 13.75 vs mean 7.85, SD 5.83; P=.02).","[{'ForeName': 'Caio Victor', 'Initials': 'CV', 'LastName': 'Sousa', 'Affiliation': 'College of Arts, Media, and Design, Bouvé College of Health Sciences, Health Technology Lab, Northeastern University, Boston, MA, United States.'}, {'ForeName': 'Austin', 'Initials': 'A', 'LastName': 'Fernandez', 'Affiliation': 'College of Arts, Media, and Design, Bouvé College of Health Sciences, Health Technology Lab, Northeastern University, Boston, MA, United States.'}, {'ForeName': 'Jungyun', 'Initials': 'J', 'LastName': 'Hwang', 'Affiliation': 'Stanford University Medical Center, Department of Medicine, Palo Alto, CA, United States.'}, {'ForeName': 'Amy Shirong', 'Initials': 'AS', 'LastName': 'Lu', 'Affiliation': 'College of Arts, Media, and Design, Bouvé College of Health Sciences, Health Technology Lab, Northeastern University, Boston, MA, United States.'}]",Journal of medical Internet research,['10.2196/17994']
172,31641058,Communicating risk differences between electronic and combusted cigarettes: the role of the FDA-mandated addiction warning and a nicotine fact sheet.,"INTRODUCTION


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


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


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


Including an addiction warning on CR messages did not reduce intentions to switch to e-cigarettes. Communicating accurate risk of nicotine together with CR messages and addiction warning increased smokers' self-efficacy beliefs about switching completely to e-cigarettes, making it a potentially promising antitobacco communication strategy.",2020,The NFS condition produced higher odds of correctly understanding the risk of nicotine and stronger beliefs that switching to e-cigarettes could reduce health risks (response efficacy) than other treatments.,['1528 US adult smokers'],"['CR messages, (2) three CR messages in condition one with an addiction warning, (3) an NFS followed by the three messages in condition 2 and (4) control messages', 'electronic and combusted cigarettes', 'electronic and combusted cigarettes (CR messages', 'nicotine fact sheet (NFS']","['message reactions and perceived effectiveness, e-cigarette-related and cigarette-related beliefs and behavioural intentions and nicotine-related beliefs', ""smokers' self-efficacy beliefs"", 'health risks (response efficacy', 'correct beliefs']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0085281', 'cui_str': 'Addictive Behavior'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0439643', 'cui_str': 'Sheets (qualifier value)'}]","[{'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C3849993', 'cui_str': 'Electronic Cigarettes'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}]",,0.0238373,The NFS condition produced higher odds of correctly understanding the risk of nicotine and stronger beliefs that switching to e-cigarettes could reduce health risks (response efficacy) than other treatments.,"[{'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Yang', 'Affiliation': 'Department of Communication, University of Arizona, Tucson, Arizona, USA.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Popova', 'Affiliation': 'School of Public Health, Georgia State University, Atlanta, Georgia, USA lpopova1@gsu.edu.'}]",Tobacco control,['10.1136/tobaccocontrol-2019-055204']
173,31427628,Regular exercise improves asthma control in adults: A randomized controlled trial.,"We conducted a randomized controlled trial to test the hypothesis that a 24-week exercise intervention improves asthma control in adults. Adults with mild or moderate asthma were randomly assigned to either the exercise intervention group (IG) or the reference group (RG). Participants in IG received an individualized exercising program, including aerobic exercise at least three times a week for ≥30 minutes, muscle training, and stretching. The primary outcome was asthma control, measured by Asthma Control Test (ACT), asthma-related symptoms, and peak expiratory flow (PEF) variability. We estimated the risk (i.e. probability) of improvement in asthma control and the risk difference (RD) between IG and RG. Of 131 subjects (67 IG/64 RG) entered, 105 subjects (51/54) completed the trial (80%), and 89 (44/45) were analysed (68%). The ACT became better among 26 (62%) participants in IG and among 17 (39%) participants in RG. The effect of intervention on improving asthma control was 23% (RD = 0.23, 95% CI 0.027-0.438; P = 0.0320). The intervention also reduced shortness of breath by 30.1% (RD = 0.301, 95% CI 0.109-0.492; P = 0.003). The change in PEF variability was similar in both groups. Regular exercise improves asthma control measured by the ACT, while has little effect on PEF variability.",2019,"The intervention also reduced shortness of breath by 30.1% (RD = 0.301, 95% CI 0.109-0.492; P = 0.003).","['131 subjects (67 IG/64 RG) entered, 105 subjects (51/54) completed the trial (80%), and 89 (44/45) were analysed (68', 'adults', 'Adults with mild or moderate asthma', 'asthma control in adults']","['exercise intervention group (IG) or the reference group (RG', 'exercise intervention', 'Regular exercise', 'individualized exercising program, including aerobic exercise at least three times a week for ≥30\u2009minutes, muscle training, and stretching']","['PEF variability', 'asthma control', 'shortness of breath', 'asthma control, measured by Asthma Control Test (ACT), asthma-related symptoms, and peak expiratory flow (PEF) variability']","[{'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0581125', 'cui_str': 'Moderate asthma'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0582191', 'cui_str': 'Regular exercise (observable entity)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0600080', 'cui_str': 'Stretching procedure (procedure)'}]","[{'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C4048375', 'cui_str': 'Asthma control test (assessment scale)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0231800', 'cui_str': 'Exhalation'}]",131.0,0.115275,"The intervention also reduced shortness of breath by 30.1% (RD = 0.301, 95% CI 0.109-0.492; P = 0.003).","[{'ForeName': 'Jouni J K', 'Initials': 'JJK', 'LastName': 'Jaakkola', 'Affiliation': 'Center for Environmental and Respiratory Health Research (CERH), University of Oulu, Oulu, Finland. jouni.jaakkola@oulu.fi.'}, {'ForeName': 'Sirpa A M', 'Initials': 'SAM', 'LastName': 'Aalto', 'Affiliation': 'Center for Environmental and Respiratory Health Research (CERH), University of Oulu, Oulu, Finland.'}, {'ForeName': 'Samu', 'Initials': 'S', 'LastName': 'Hernberg', 'Affiliation': 'Center for Environmental and Respiratory Health Research (CERH), University of Oulu, Oulu, Finland.'}, {'ForeName': 'Simo-Pekka', 'Initials': 'SP', 'LastName': 'Kiihamäki', 'Affiliation': 'Center for Environmental and Respiratory Health Research (CERH), University of Oulu, Oulu, Finland.'}, {'ForeName': 'Maritta S', 'Initials': 'MS', 'LastName': 'Jaakkola', 'Affiliation': 'Center for Environmental and Respiratory Health Research (CERH), University of Oulu, Oulu, Finland.'}]",Scientific reports,['10.1038/s41598-019-48484-8']
174,31427637,Statin treatment after acute coronary syndrome: Adherence and reasons for non-adherence in a randomized controlled intervention trial.,"Studies of secondary prevention for cardiovascular disease show low fulfilment of guideline-recommended targets. This study explored whether nurse-led follow-up could increase adherence to statins over time and reasons for discontinuation. All patients admitted for acute coronary syndrome at Östersund hospital between 2010-2014 were screened for the randomized controlled NAILED-ACS trial. The trial comprises two groups, one with nurse-led annual follow-up and medical titration by telephone to reach set intervention targets and one with usual care. All discontinuations of statins were recorded prospectively for at least 36 months and categorized as avoidable or unavoidable. Kaplan-Meier estimates were conducted for first and permanent discontinuations. Predictors for discontinuation were analysed using multivariate Cox regression, statin type and mean LDL-C at end of follow-up. Female gender was a predictor for discontinuation. Allocation in the intervention group predicted increased risk for a first but decreased risk for permanent discontinuation. A nurse-led telemedical secondary prevention programme in a relatively unselected ACS cohort leads to increased adherence to statins over time, greater percentage on potent treatment and lower LDL-C compared to usual care. An initially increased tendency toward early discontinuation in the intervention group stresses the importance of a longer duration of structured follow-up.",2019,"A nurse-led telemedical secondary prevention programme in a relatively unselected ACS cohort leads to increased adherence to statins over time, greater percentage on potent treatment and lower LDL-C compared to usual care.","['after acute coronary syndrome', 'All patients admitted for acute coronary syndrome at Östersund hospital between 2010-2014 were screened for the randomized controlled NAILED-ACS trial']","['Statin treatment', 'nurse-led annual follow-up and medical titration by telephone to reach set intervention targets and one with usual care']",[],"[{'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0027342', 'cui_str': 'Nails'}]","[{'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0036849', 'cui_str': 'Set'}]",[],2014.0,0.0324895,"A nurse-led telemedical secondary prevention programme in a relatively unselected ACS cohort leads to increased adherence to statins over time, greater percentage on potent treatment and lower LDL-C compared to usual care.","[{'ForeName': 'Huber', 'Initials': 'H', 'LastName': 'Daniel', 'Affiliation': 'Department of Public Health and Clinical Medicine, Unit of Research, Education and Development - Östersund, Umeå University, Östersund, Sweden. daniel.huber@regionjh.se.'}, {'ForeName': 'Wikén', 'Initials': 'W', 'LastName': 'Christian', 'Affiliation': 'Department of Public Health and Clinical Medicine, Unit of Research, Education and Development - Östersund, Umeå University, Östersund, Sweden.'}, {'ForeName': 'Henriksson', 'Initials': 'H', 'LastName': 'Robin', 'Affiliation': 'Department of Public Health and Clinical Medicine, Unit of Research, Education and Development - Östersund, Umeå University, Östersund, Sweden.'}, {'ForeName': 'Söderström', 'Initials': 'S', 'LastName': 'Lars', 'Affiliation': 'Unit of Research, Development and Education, Region Jämtland Härjedalen, Östersund Hospital, Östersund, Sweden.'}, {'ForeName': 'Mooe', 'Initials': 'M', 'LastName': 'Thomas', 'Affiliation': 'Department of Public Health and Clinical Medicine, Unit of Research, Education and Development - Östersund, Umeå University, Östersund, Sweden.'}]",Scientific reports,['10.1038/s41598-019-48540-3']
175,32323868,Changes in problematic activities of daily living in persons with COPD during 1 year of usual care.,"INTRODUCTION


Persons with chronic obstructive pulmonary disease (COPD) are often limited in performing their activities of daily living (ADLs). However, it remains unknown whether and to what extent problematic ADLs change over time and whether exacerbation-related hospitalisations affect problematic ADLs. Therefore, we investigated self-reported problematic ADLs of persons with COPD during 1 year of usual care (i.e. without a specific experimental intervention).
METHODS


Stable persons with moderate to very severe COPD (n = 137) were included in this longitudinal study (registered in the Dutch Trial Register [NTR 3941]). Participants were visited at home at baseline and after 1 year. Participants with an exacerbation-related hospitalisation during follow-up were visited additionally within 2 weeks after hospital discharge. During all visits, participants' personalised problematic ADLs were assessed using the Canadian Occupational Performance Measure (COPM), and perceived performance and satisfaction of important problematic ADLs were rated on a 10-point scale.
RESULTS


In total, 90% of the participants reported at least one new important problematic ADL after 1 year. In the subgroup of participants with an exacerbation-related hospitalisation (n = 31), 92% of the participants reported new problematic ADLs 2 weeks after discharge and 90% reported new problematic ADLs again after 1 year. Only the satisfaction score of problematic ADLs as mentioned during baseline improved after 1-year follow-up in all participants (p = .002) and in participants without an exacerbation-related hospitalisation (n = 106; p = .014).
CONCLUSION


Problematic ADLs changed during 1 year of usual care, which underlines the need for regular assessment of problematic ADLs and referral to treatment options like monodisciplinary occupational therapy and/or a comprehensive pulmonary rehabilitation programme.",2020,"Only the satisfaction score of problematic ADLs as mentioned during baseline improved after 1-year follow-up in all participants (p = .002) and in participants without an exacerbation-related hospitalisation (n = 106; p = .014).
","['persons with COPD during 1\xa0year of usual care (i.e. without a specific experimental intervention', 'Persons with chronic obstructive pulmonary disease (COPD', 'Stable persons with moderate to very severe COPD', 'n\xa0=\xa0137) were included in this longitudinal study (registered in the Dutch Trial Register [NTR 3941', 'Participants with an exacerbation-related hospitalisation during follow-up were visited additionally within 2\xa0weeks after hospital discharge', 'persons with COPD during 1 year of usual care']",[],"['Canadian Occupational Performance Measure (COPM), and perceived performance and satisfaction of important problematic ADLs', 'satisfaction score of problematic ADLs']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C3641272', 'cui_str': 'Very severe'}, {'cui': 'C4517569', 'cui_str': '137'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}]",[],"[{'cui': 'C2585956', 'cui_str': 'Canadian occupational performance measure'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",137.0,0.160733,"Only the satisfaction score of problematic ADLs as mentioned during baseline improved after 1-year follow-up in all participants (p = .002) and in participants without an exacerbation-related hospitalisation (n = 106; p = .014).
","[{'ForeName': 'Nienke', 'Initials': 'N', 'LastName': 'Nakken', 'Affiliation': 'Department of Research and Development, CIRO, Horn, the Netherlands.'}, {'ForeName': 'Daisy J A', 'Initials': 'DJA', 'LastName': 'Janssen', 'Affiliation': 'Department of Research and Development, CIRO, Horn, the Netherlands.'}, {'ForeName': 'Emiel F M', 'Initials': 'EFM', 'LastName': 'Wouters', 'Affiliation': 'Department of Research and Development, CIRO, Horn, the Netherlands.'}, {'ForeName': 'Esther H A', 'Initials': 'EHA', 'LastName': 'van den Bogaart', 'Affiliation': 'Department of Research and Development, CIRO, Horn, the Netherlands.'}, {'ForeName': 'Jean W M', 'Initials': 'JWM', 'LastName': 'Muris', 'Affiliation': 'Department of Family Medicine, CAPHRI Care and Public Health Research Institute, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Geeuwke J', 'Initials': 'GJ', 'LastName': 'de Vries', 'Affiliation': 'Department of Respiratory Medicine, Zuyderland, Sittard-Geleen, the Netherlands.'}, {'ForeName': 'Gerben P', 'Initials': 'GP', 'LastName': 'Bootsma', 'Affiliation': 'Department of Respiratory Medicine, Zuyderland, Heerlen, the Netherlands.'}, {'ForeName': 'Michiel H M', 'Initials': 'MHM', 'LastName': 'Gronenschild', 'Affiliation': 'Department of Respiratory Medicine, Zuyderland, Heerlen, the Netherlands.'}, {'ForeName': 'Jeannet M L', 'Initials': 'JML', 'LastName': 'Delbressine', 'Affiliation': 'Department of Research and Development, CIRO, Horn, the Netherlands.'}, {'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'van Vliet', 'Affiliation': 'Department of Respiratory Medicine, Zuyderland, Heerlen, the Netherlands.'}, {'ForeName': 'Martijn A', 'Initials': 'MA', 'LastName': 'Spruit', 'Affiliation': 'Department of Research and Development, CIRO, Horn, the Netherlands.'}]",Australian occupational therapy journal,['10.1111/1440-1630.12664']
176,31641214,Preoperative liking and wanting for sweet beverages as predictors of body weight loss after Roux-en-Y gastric bypass and sleeve gastrectomy.,"BACKGROUND/OBJECTIVES


Patients who receive Roux-en-Y gastric bypass (RYGB) lose more weight than those who receive vertical sleeve gastrectomy (VSG). RYGB and VSG alter hedonic responses to sweet flavor, but whether baseline differences in hedonic responses modulate weight loss after RYGB or VSG remains untested.
PARTICIPANTS/METHODS


Male and female candidates (n = 66) for RYGB or VSG were recruited and tested for their subjective liking and wanting ratings of sucrose solutions and flavored beverages sweetened with aspartame. Participants were classified by unsupervised hierarchical clustering for their liking and wanting ratings of sucrose and aspartame. Participant liking ratings were also used in a supervised classification using pre-established categories of liking ratings (liker, disliker, and inverted u-shape). Effects of categories obtained from unsupervised or supervised classification on body weight loss and their interaction with surgery type were analyzed separately at 3 and 12 months after surgery using linear models corrected for sex and age.
RESULTS


RYGB participants lost more body weight compared with VSG participants at 3 and 12 months after surgery (P < 0.001 for both time points). Unsupervised clustering analysis identified clusters corresponding to high and low wanting or liking ratings for sucrose or aspartame. RYGB participants in high-wanting clusters based on sucrose, but not aspartame, lost more weight than VSG at both 3 (P = 0.01) and 12 months (P = 0.03), yielding a significant cluster by surgery interaction. Categories based on supervised classification using liking ratings for sucrose or aspartame showed no significant effects on body weight loss between RYGB and VSG participants.
CONCLUSIONS


Classification of patients into high/low-wanting ratings for sucrose before surgery can predict differential body weight loss after RYGB or VSG in adults and could be used to advise on surgery type.",2020,"Categories based on supervised classification using liking ratings for sucrose or aspartame showed no significant effects on body weight loss between RYGB and VSG participants.
","['Patients who receive', 'Male and female candidates (n\u2009=\u200966) for RYGB or VSG']","['Roux-en-Y gastric bypass and sleeve gastrectomy', 'Preoperative liking and wanting for sweet beverages', 'RYGB and VSG', 'Roux-en-Y gastric bypass (RYGB', 'vertical sleeve gastrectomy (VSG', 'sucrose solutions and flavored beverages sweetened with aspartame', 'Unsupervised clustering analysis identified clusters corresponding to high and low wanting or liking ratings for sucrose or aspartame']","['Participant liking ratings', 'body weight', 'body weight loss']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0585179', 'cui_str': 'Roux-en-Y Gastric Bypass'}, {'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C1444647', 'cui_str': 'Wanted'}, {'cui': 'C0453447', 'cui_str': 'Sugar candy'}, {'cui': 'C0005329', 'cui_str': 'Beverages'}, {'cui': 'C0205128', 'cui_str': 'Vertical (qualifier value)'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0003999', 'cui_str': 'Aspartame'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]","[{'cui': 'C0005910', 'cui_str': 'Body Weight'}]",,0.0158572,"Categories based on supervised classification using liking ratings for sucrose or aspartame showed no significant effects on body weight loss between RYGB and VSG participants.
","[{'ForeName': 'Claudio E', 'Initials': 'CE', 'LastName': 'Perez-Leighton', 'Affiliation': 'Department of Physiology, School of Biological Sciences, Pontificia Universidad Católica, Santiago, Chile.'}, {'ForeName': 'Jeon D', 'Initials': 'JD', 'LastName': 'Hamm', 'Affiliation': 'Department of Medicine, New York Nutrition Obesity Research Center and Division of Endocrinology, Vagelos College of Physicians and Surgeons, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Ari', 'Initials': 'A', 'LastName': 'Shechter', 'Affiliation': 'Department of Medicine, New York Nutrition Obesity Research Center and Division of Endocrinology, Vagelos College of Physicians and Surgeons, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Shoran', 'Initials': 'S', 'LastName': 'Tamura', 'Affiliation': 'Department of Medicine, New York Nutrition Obesity Research Center and Division of Endocrinology, Vagelos College of Physicians and Surgeons, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Blandine', 'Initials': 'B', 'LastName': 'Laferrère', 'Affiliation': 'Department of Medicine, New York Nutrition Obesity Research Center and Division of Endocrinology, Vagelos College of Physicians and Surgeons, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Xavier Pi-Sunyer', 'Affiliation': 'Department of Medicine, New York Nutrition Obesity Research Center and Division of Endocrinology, Vagelos College of Physicians and Surgeons, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Jeanine', 'Initials': 'J', 'LastName': 'Albu', 'Affiliation': ""Mt. Sinai St. Luke's Hospital, New York, NY, USA.""}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Greenberg', 'Affiliation': 'NutriSci Incorporated, Mt. Kisco, NY, USA.'}, {'ForeName': 'Harry R', 'Initials': 'HR', 'LastName': 'Kissileff', 'Affiliation': 'Department of Medicine, New York Nutrition Obesity Research Center and Division of Endocrinology, Vagelos College of Physicians and Surgeons, Columbia University Irving Medical Center, New York, NY, USA. Harry.Kissileff2@mountsinai.org.'}]",International journal of obesity (2005),['10.1038/s41366-019-0474-1']
177,31794974,One-year clinical outcomes following theta burst stimulation for post-traumatic stress disorder.,"Theta burst transcranial magnetic stimulation (TBS) is a potential new treatment for post-traumatic stress disorder (PTSD). We previously reported active intermittent TBS (iTBS) was associated with superior clinical outcomes for up to 1-month, in a sample of fifty veterans with PTSD, using a crossover design. In that study, participants randomized to the active group received a total of 4-weeks of active iTBS, or 2-weeks if randomized to sham. Results were superior with greater exposure to active iTBS, which raised the question of whether observed effects persisted over the longer-term. This study reviewed naturalistic outcomes up to 1-year from study endpoint, to test the hypothesis that greater exposure to active iTBS would be associated with superior outcomes. The primary outcome measure was clinical relapse, defined as any serious adverse event (e.g., suicide, psychiatric hospitalization, etc.,) or need for retreatment with repetitive transcranial magnetic stimulation (rTMS). Forty-six (92%) of the initial study's intent-to-treat participants were included. Mean age was 51.0 ± 12.3 years and seven (15.2%) were female. The group originally randomized to active iTBS (4-weeks active iTBS) demonstrated superior outcomes at one year compared to those originally randomized to sham (2-weeks active iTBS); log-rank ChiSq = 5.871, df = 1, p = 0.015; OR = 3.50, 95% CI = 1.04-11.79. Mean days to relapse were 296.0 ± 22.1 in the 4-week group, and 182.0 ± 31.9 in the 2-week group. When used, rTMS retreatment was generally effective. Exploratory neuroimaging revealed default mode network connectivity was predictive of 1-year outcomes (corrected p < 0.05). In summary, greater accumulated exposure to active iTBS demonstrated clinically meaningful improvements in the year following stimulation, and default mode connectivity could be used to predict longer-term outcomes.",2020,"The group originally randomized to active iTBS (4-weeks active iTBS) demonstrated superior outcomes at one year compared to those originally randomized to sham (2-weeks active iTBS); log-rank ChiSq = 5.871, df = 1, p = 0.015; OR = 3.50, 95% CI = 1.04-11.79.","['post-traumatic stress disorder (PTSD', 'Mean age was 51.0\u2009±\u200912.3 years and seven (15.2%) were female', 'fifty veterans with PTSD', ""Forty-six (92%) of the initial study's intent-to-treat participants were included""]","['total of 4-weeks of active iTBS', 'active iTBS (4-weeks active iTBS', 'theta burst stimulation', 'active intermittent TBS (iTBS', 'Theta burst transcranial magnetic stimulation (TBS', 'TMS']","['clinical relapse, defined as any serious adverse event (e.g., suicide, psychiatric hospitalization, etc.,) or need for retreatment with repetitive transcranial magnetic stimulation (rTMS', 'Mean days to relapse']","[{'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation (procedure)'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0852733', 'cui_str': 'Suicide (accomplished)'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0376495', 'cui_str': 'Retreatments'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",50.0,0.149203,"The group originally randomized to active iTBS (4-weeks active iTBS) demonstrated superior outcomes at one year compared to those originally randomized to sham (2-weeks active iTBS); log-rank ChiSq = 5.871, df = 1, p = 0.015; OR = 3.50, 95% CI = 1.04-11.79.","[{'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Petrosino', 'Affiliation': 'From the VA RR&D Center for Neurorestoration and Neurotechnology, Providence VA Medical Center, and The Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI, 02903, USA.'}, {'ForeName': ""Mascha van 't"", 'Initials': ""MV'"", 'LastName': 'Wout-Frank', 'Affiliation': 'From the VA RR&D Center for Neurorestoration and Neurotechnology, Providence VA Medical Center, and The Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI, 02903, USA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Aiken', 'Affiliation': 'From the VA RR&D Center for Neurorestoration and Neurotechnology, Providence VA Medical Center, and The Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI, 02903, USA.'}, {'ForeName': 'Hannah R', 'Initials': 'HR', 'LastName': 'Swearingen', 'Affiliation': 'From the VA RR&D Center for Neurorestoration and Neurotechnology, Providence VA Medical Center, and The Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI, 02903, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Barredo', 'Affiliation': 'From the VA RR&D Center for Neurorestoration and Neurotechnology, Providence VA Medical Center, and The Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI, 02903, USA.'}, {'ForeName': 'Amin', 'Initials': 'A', 'LastName': 'Zandvakili', 'Affiliation': 'From the VA RR&D Center for Neurorestoration and Neurotechnology, Providence VA Medical Center, and The Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI, 02903, USA.'}, {'ForeName': 'Noah S', 'Initials': 'NS', 'LastName': 'Philip', 'Affiliation': 'From the VA RR&D Center for Neurorestoration and Neurotechnology, Providence VA Medical Center, and The Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI, 02903, USA. noah_philip@brown.edu.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0584-4']
178,31802716,A Randomized Trial of Intravenous Thyroxine for Brain-Dead Organ Donors With Impaired Cardiac Function.,"RATIONALE


Brain death (BD) precipitates cardiac dysfunction impairing the ability to transplant hearts from eligible organ donors. Retrospective studies have suggested that thyroid hormone may enhance myocardial recovery and increase hearts transplanted. We performed a randomized trial evaluating whether intravenous thyroxine (T4) improves cardiac function in BD donors with impaired ejection fraction (EF).
METHODS


All heart-eligible donors managed at a single-organ procurement organization (OPO) underwent protocolized fluid resuscitation. Those weaned off vasopressors underwent transthoracic echocardiography (TTE) within 12 hours of BD and, if EF was below 60%, were randomized to T4 infusion or no T4 for 8 hours, after which TTE was repeated.
RESULTS


Of 77 heart-eligible donors, 36 were weaned off vasopressors. Ejection fraction was depressed in 30, of whom 28 were randomized to T4 (n = 17) vs control (n = 11). Baseline EF was comparable (45%, interquartile range [IQR] 42.5-47.5 vs 40%, 40-50,  P  = .32). Ejection fraction did not improve more with T4 (10%, IQR 5-15 vs 5%, 0-12.5,  P  = .24), although there was a trend to more hearts transplanted (59% vs 27%,  P  = .14). This difference appeared to be accounted for by more donors with a history of drug use in the T4 group, who exhibited greater improvements in EF (15% vs 0% without drug use,  P  = .01) and more often had hearts transplanted (12 of 19 vs 1 of 9,  P  = .01).
CONCLUSIONS


In this small randomized study of BD donors with impaired cardiac function, T4 infusion did not result in greater cardiac recovery. A larger randomized trial comparing T4 to placebo appears warranted but would require collaboration across multiple OPOs.",2020,"Ejection fraction did not improve more with T4 (10%, IQR 5-15 vs 5%, 0-12.5,  P  = .24), although there was a trend to more hearts transplanted (59% vs 27%,  P  = .14).","['All heart-eligible donors managed at a single-organ procurement organization (OPO) underwent protocolized fluid resuscitation', 'BD donors with impaired ejection fraction (EF', 'Brain-Dead Organ Donors With Impaired Cardiac Function', '77 heart-eligible donors', 'transplant hearts from eligible organ donors']","['Intravenous Thyroxine', 'transthoracic echocardiography (TTE', 'placebo', 'intravenous thyroxine (T4']","['cardiac recovery', 'Ejection fraction', 'cardiac function', 'Baseline EF', 'EF']","[{'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0029210', 'cui_str': 'Organ Procurement'}, {'cui': 'C0220885', 'cui_str': 'organization'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0006110', 'cui_str': 'Brain Dead'}, {'cui': 'C0029206', 'cui_str': 'Organ donor (person)'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function (observable entity)'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0202231', 'cui_str': 'Thyroxine measurement (procedure)'}, {'cui': 'C0430462', 'cui_str': 'Transthoracic echocardiography (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function (observable entity)'}]",77.0,0.124132,"Ejection fraction did not improve more with T4 (10%, IQR 5-15 vs 5%, 0-12.5,  P  = .24), although there was a trend to more hearts transplanted (59% vs 27%,  P  = .14).","[{'ForeName': 'Rajat', 'Initials': 'R', 'LastName': 'Dhar', 'Affiliation': 'Division of Neurocritical Care, Department of Neurology, Washington University School of Medicine in St Louis, MO, USA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Stahlschmidt', 'Affiliation': 'Mid-America Transplant, St Louis, MO, USA.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Marklin', 'Affiliation': 'Mid-America Transplant, St Louis, MO, USA.'}]","Progress in transplantation (Aliso Viejo, Calif.)",['10.1177/1526924819893295']
179,32321161,Evenly Distributed Protein Intake over 3 Meals Augments Resistance Exercise-Induced Muscle Hypertrophy in Healthy Young Men.,"BACKGROUND


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


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


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


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


For RT-induced muscle hypertrophy in healthy young men, consuming a protein-enriched meal at breakfast and less protein at dinner while achieving an adequate overall PI is more effective than consuming more protein at dinner.This study was registered at University hospital Medical Information Network (UMIN) Clinical Trials Registry as UMIN000037583 (https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042763).",2020,The total LTM at baseline did not differ between the HBR (52.4 ± 1.3 kg) and LBR (53.4 ± 1.2 kg) groups.,"['Healthy Young Men', '26 men (means\xa0±\xa0SEs; age: 20.8\xa0±\xa00.4 y; BMI: 21.8\xa0±\xa00.4\xa0kg/m2', 'healthy young men', 'registered at University hospital Medical Information Network (UMIN']","['protein-enriched meal at breakfast', 'DXA', 'low breakfast"" (LBR', 'Evenly Distributed Protein Intake over 3 Meals Augments Resistance Exercise-Induced Muscle Hypertrophy', 'supervised resistance training (RT', 'high breakfast"" (HBR']","['total LTM', 'total lean soft tissue mass (LTM']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517457', 'cui_str': '0.4'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0021419', 'cui_str': 'Information Networks'}]","[{'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0236033', 'cui_str': 'Muscle hypertrophy'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0457193', 'cui_str': 'Soft tissue mass'}]",26.0,0.0519553,The total LTM at baseline did not differ between the HBR (52.4 ± 1.3 kg) and LBR (53.4 ± 1.2 kg) groups.,"[{'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Yasuda', 'Affiliation': 'Faculty of Sport and Health Science, Ritsumeikan University, Nojihigashi, Kusatsu, Shiga, Japan.'}, {'ForeName': 'Toshiki', 'Initials': 'T', 'LastName': 'Tomita', 'Affiliation': 'Faculty of Sport and Health Science, Ritsumeikan University, Nojihigashi, Kusatsu, Shiga, Japan.'}, {'ForeName': 'Takuma', 'Initials': 'T', 'LastName': 'Arimitsu', 'Affiliation': 'Faculty of Sport and Health Science, Ritsumeikan University, Nojihigashi, Kusatsu, Shiga, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Fujita', 'Affiliation': 'Faculty of Sport and Health Science, Ritsumeikan University, Nojihigashi, Kusatsu, Shiga, Japan.'}]",The Journal of nutrition,['10.1093/jn/nxaa101']
180,32101272,"Pancreaticojejunostomy With Externalized Stent vs Pancreaticogastrostomy With Externalized Stent for Patients With High-Risk Pancreatic Anastomosis: A Single-Center, Phase 3, Randomized Clinical Trial.","Importance


The operative scenarios with the highest postoperative pancreatic fistula (POPF) risk represent situations in which fistula prevention and mitigation strategies have the strongest potential to affect surgical outcomes after pancreaticoduodenectomy. Evidence from studies providing risk stratification is lacking.
Objective


To investigate whether pancreaticojejunostomy (PJ) or pancreaticogastrostomy (PG), both with externalized transanastomotic stent, is the best reconstruction method for patients at high risk of POPF after pancreaticoduodenectomy.
Design, Setting, and Participants


A single-center, phase 3, randomized clinical trial was conducted at the Department of General and Pancreatic Surgery, The Pancreas Institute, University of Verona Hospital Trust, Verona, Italy, from July 12, 2017, through March 15, 2019, among adults undergoing elective pancreaticoduodenectomy and considered at high risk for pancreatic fistula after intraoperative assessment of the fistula risk score, some of whom were randomized to undergo PG or PJ. All analyses were performed on an intention-to-treat basis.
Interventions


Intervention consisted of PJ or PG, both with externalized transanastomotic stent and octreotide omission.
Main Outcomes and Measures


The primary end point was POPF. The secondary end points were Clavien-Dindo grade 3 or higher morbidity, postpancreatectomy hemorrhage, delayed gastric emptying, and average complication burden.
Results


A total of 604 patients were screened for eligibility; 82 were at high risk for POPF (fistula risk score, 7-10), and 72 were randomized undergo PG (n = 36; 20 men and 16 women; median age, 65 years [interquartile range, 23-82]) or PJ (n = 36; 26 men and 10 women; median age, 63 years [interquartile range, 35-79]). There was no significant difference in the incidence of POPF between patients who underwent PG and patients who underwent PJ (18 [50.0%] vs 14 [38.9%]; P = .48), but for patients who developed a POPF, the mean (SD) average complication burden was lower for those who underwent PJ than for those who underwent PG (0.25 [0.13] vs 0.39 [0.17]; P = .04). The rates of postpancreatectomy hemorrhage (14 [38.9%] in the PG group vs 9 [25.0%] in the PJ group; P = .31) and delayed gastric emptying (16 [44.4%] in the PG group vs 18 [50.0%] in the PJ group; P = .81) were similar, but patients who underwent PG presented with a significantly higher incidence of Clavien-Dindo grade 3 or higher morbidity than those who underwent PJ (17 [47.2%] vs 8 [22.2%]; P = .047).
Conclusions and Relevance


Among patients at the highest risk for POPF, those who underwent PG or PJ experienced similar rates of POPF. However, PG was associated with an increased incidence of Clavien-Dindo grade 3 or higher morbidity and with an increased average complication burden for the patients who developed a POPF. For patients at high risk for pancreatic fistula, PJ with the use of externalized stent and octreotide omission should be considered the most appropriate technical strategy.
Trial Registration


ClinicalTrials.gov Identifier: NCT03212196.",2020,"The rates of postpancreatectomy hemorrhage (14 [38.9%] in the PG group vs 9 [25.0%] in the PJ group; P = .31) and delayed gastric emptying (16 [44.4%] in the PG group vs 18 [50.0%] in the PJ group; P = .81) were similar, but patients who underwent PG presented with a significantly higher incidence of Clavien-Dindo grade 3 or higher morbidity than those who underwent PJ (17 [47.2%] vs 8 [22.2%]; P = .047).
","['Patients', 'With High-Risk Pancreatic Anastomosis', 'Participants\n\n\nA single-center, phase 3, randomized clinical trial was conducted at the Department of General and Pancreatic Surgery, The Pancreas Institute, University of Verona Hospital Trust, Verona, Italy, from July 12, 2017, through March 15, 2019, among adults undergoing elective pancreaticoduodenectomy and considered at high risk for pancreatic fistula after intraoperative assessment of the fistula risk score', '604 patients were screened for eligibility; 82 were at high risk for POPF (fistula risk score, 7-10), and 72 were randomized undergo PG (n\u2009=\u200936; 20 men and 16 women; median age, 65 years [interquartile range, 23-82]) or PJ (n\u2009=\u200936; 26 men and 10 women; median age, 63 years [interquartile range, 35-79', 'patients at high risk of POPF after pancreaticoduodenectomy']","['Externalized Stent vs Pancreaticogastrostomy With Externalized Stent', 'PJ or PG, both with externalized transanastomotic stent and octreotide omission', 'PG or PJ', 'pancreaticojejunostomy (PJ) or pancreaticogastrostomy (PG), both with externalized transanastomotic stent', 'externalized stent and octreotide omission']","['delayed gastric emptying', 'Clavien-Dindo grade 3 or higher morbidity, postpancreatectomy hemorrhage, delayed gastric emptying, and average complication burden', 'incidence of Clavien-Dindo grade 3 or higher morbidity', 'mean (SD) average complication burden', 'rates of postpancreatectomy hemorrhage', 'rates of POPF', 'POPF', 'incidence of POPF']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis (morphologic abnormality)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0439561', 'cui_str': 'Phase 3 (qualifier value)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0085162', 'cui_str': 'Pancreatoduodenectomy'}, {'cui': 'C0030290', 'cui_str': 'Pancreatic Fistula'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C1533621', 'cui_str': 'Pancreas to stomach anastomosis (procedure)'}, {'cui': 'C0028833', 'cui_str': 'Octreotide'}, {'cui': 'C0030303', 'cui_str': 'Pancreatojejunostomy'}]","[{'cui': 'C0740411', 'cui_str': 'Delayed gastric emptying (disorder)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C1869041', 'cui_str': 'Haemorrhages (SMQ)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",604.0,0.257267,"The rates of postpancreatectomy hemorrhage (14 [38.9%] in the PG group vs 9 [25.0%] in the PJ group; P = .31) and delayed gastric emptying (16 [44.4%] in the PG group vs 18 [50.0%] in the PJ group; P = .81) were similar, but patients who underwent PG presented with a significantly higher incidence of Clavien-Dindo grade 3 or higher morbidity than those who underwent PJ (17 [47.2%] vs 8 [22.2%]; P = .047).
","[{'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Andrianello', 'Affiliation': 'The Pancreas Institute, Department of General and Pancreatic Surgery, University of Verona Hospital Trust, Verona, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Marchegiani', 'Affiliation': 'The Pancreas Institute, Department of General and Pancreatic Surgery, University of Verona Hospital Trust, Verona, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Malleo', 'Affiliation': 'The Pancreas Institute, Department of General and Pancreatic Surgery, University of Verona Hospital Trust, Verona, Italy.'}, {'ForeName': 'Gaia', 'Initials': 'G', 'LastName': 'Masini', 'Affiliation': 'The Pancreas Institute, Department of General and Pancreatic Surgery, University of Verona Hospital Trust, Verona, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Balduzzi', 'Affiliation': 'The Pancreas Institute, Department of General and Pancreatic Surgery, University of Verona Hospital Trust, Verona, Italy.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Paiella', 'Affiliation': 'The Pancreas Institute, Department of General and Pancreatic Surgery, University of Verona Hospital Trust, Verona, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Esposito', 'Affiliation': 'The Pancreas Institute, Department of General and Pancreatic Surgery, University of Verona Hospital Trust, Verona, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Landoni', 'Affiliation': 'The Pancreas Institute, Department of General and Pancreatic Surgery, University of Verona Hospital Trust, Verona, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Casetti', 'Affiliation': 'The Pancreas Institute, Department of General and Pancreatic Surgery, University of Verona Hospital Trust, Verona, Italy.'}, {'ForeName': 'Massimiliano', 'Initials': 'M', 'LastName': 'Tuveri', 'Affiliation': 'The Pancreas Institute, Department of General and Pancreatic Surgery, University of Verona Hospital Trust, Verona, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Salvia', 'Affiliation': 'The Pancreas Institute, Department of General and Pancreatic Surgery, University of Verona Hospital Trust, Verona, Italy.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Bassi', 'Affiliation': 'The Pancreas Institute, Department of General and Pancreatic Surgery, University of Verona Hospital Trust, Verona, Italy.'}]",JAMA surgery,['10.1001/jamasurg.2019.6035']
181,32224483,Experiences of Internet-Based Stepped Care in Individuals With Cancer and Concurrent Symptoms of Anxiety and Depression: Qualitative Exploration Conducted Alongside the U-CARE AdultCan Randomized Controlled Trial.,"BACKGROUND


Individuals with newly diagnosed cancer may experience impaired health in several aspects and often have a large need for information and support. About 30% will experience symptoms of anxiety and depression, with varying needs of knowledge and support. Despite this, many of these patients lack appropriate support. Internet-based support programs may offer a supplement to standard care services, but must be carefully explored from a user perspective.
OBJECTIVE


The purpose of this study was to explore the participants' perceptions of the relevance and benefits of an internet-based stepped care program (iCAN-DO) targeting individuals with cancer and concurrent symptoms of anxiety and depression.
METHODS


We performed a qualitative study with an inductive approach, in which we used semistructured questions to interview 15 individuals using iCAN-DO. We analyzed the interviews using content analysis.
RESULTS


The analysis found 17 subcategories regarding the stepped care intervention, resulting in 4 categories. Participants described the need for information as large and looked upon finding information almost as a survival strategy when receiving the cancer diagnosis. iCAN-DO was seen as a useful, reliable source of information and support. It was used as a complement to standard care and as a means to inform next of kin. Increased knowledge was a foundation for continued processing of participants' own feelings. The optimal time to gain access to iCAN-DO would have been when being informed of the diagnosis. The most common denominator was feeling acknowledged and supported, but with a desire for further adaptation of the system to each individual's own situation and needs.
CONCLUSIONS


Users saw the internet-based stepped care program as safe and reliable and used it as a complement to standard care. Similar interventions may gain from more personalized contents, being integrated into standard care, or using symptom tracking to adjust the contents. Offering this type of program close to diagnosis may provide benefits to users.
TRIAL REGISTRATION


ClincalTrials.gov NCT-01630681; https://clinicaltrials.gov/ct2/show/NCT01630681.",2020,"CONCLUSIONS


Users saw the internet-based stepped care program as safe and reliable and used it as a complement to standard care.","['Individuals With Cancer and Concurrent Symptoms of Anxiety and Depression', 'Individuals with newly diagnosed cancer', 'individuals with cancer and concurrent symptoms of anxiety and depression']","['U-CARE', 'internet-based stepped care program (iCAN-DO', 'Internet-Based Stepped Care']",[],"[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C2728259', 'cui_str': 'Program'}]",[],,0.105588,"CONCLUSIONS


Users saw the internet-based stepped care program as safe and reliable and used it as a complement to standard care.","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Hauffman', 'Affiliation': 'Department of Immunology, Genetics and Pathology, Section of Experimental and Clinical Oncology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Alfonsson', 'Affiliation': ""Department of Women's and Children's Health, Section of Clinical Psychology in Healthcare, Uppsala University, Uppsala, Sweden.""}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Igelström', 'Affiliation': 'Department of Immunology, Genetics and Pathology, Section of Experimental and Clinical Oncology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Birgitta', 'Initials': 'B', 'LastName': 'Johansson', 'Affiliation': 'Department of Immunology, Genetics and Pathology, Section of Experimental and Clinical Oncology, Uppsala University, Uppsala, Sweden.'}]",Journal of medical Internet research,['10.2196/16547']
182,32224489,Affect-Focused Psychodynamic Internet-Based Therapy for Adolescent Depression: Randomized Controlled Trial.,"BACKGROUND


Adolescent depression is one of the largest health issues in the world and there is a pressing need for effective and accessible treatments.
OBJECTIVE


This trial examines whether affect-focused internet-based psychodynamic therapy (IPDT) with therapist support is more effective than an internet-based supportive control condition on reducing depression in adolescents.
METHODS


The trial included 76 adolescents (61/76, 80% female; mean age 16.6 years), self-referred via an open access website and fulfilling criteria for major depressive disorder. Adolescents were randomized to 8 weeks of IPDT (38/76, 50%) or supportive control (38/76, 50%). The primary outcome was self-reported depressive symptoms, measured with the Quick Inventory of Depressive Symptomatology for Adolescents (QIDS-A17-SR). Secondary outcomes were anxiety severity, emotion regulation, self-compassion, and an additional depression measure. Assessments were made at baseline, postassessment, and at 6 months follow-up, in addition to weekly assessments of the primary outcome measure as well as emotion regulation during treatment.
RESULTS


IPDT was significantly more effective than the control condition in reducing depression (d=0.82, P=.01), the result of which was corroborated by the second depression measure (d=0.80, P<.001). IPDT was also significantly more effective in reducing anxiety (d=0.78, P<.001) and increasing emotion regulation (d=0.97, P<.001) and self-compassion (d=0.65, P=.003). Significantly more patients in the IPDT group compared to the control group met criteria for response (56% vs 21%, respectively) and remission (35% vs 8%, respectively). Results on depression and anxiety symptoms were stable at 6 months follow-up. On average, participants completed 5.8 (SD 2.4) of the 8 modules.
CONCLUSIONS


IPDT may be an effective intervention to reduce adolescent depression. Further research is needed, including comparisons with other treatments.
TRIAL REGISTRATION


International Standard Randomised Controlled Trial Number (ISRCTN) 16206254; http://www.isrctn.com/ISRCTN16206254.",2020,"IPDT was also significantly more effective in reducing anxiety (d=0.78, P<.001) and increasing emotion regulation (d=0.97, P<.001) and self-compassion (d=0.65, P=.003).","['Adolescent Depression', 'Adolescents', '76 adolescents (61/76, 80% female; mean age 16.6 years), self-referred via an open access website and fulfilling criteria for major depressive disorder', 'adolescents']","['internet-based psychodynamic therapy (IPDT', 'Psychodynamic Internet-Based Therapy', 'supportive control', 'IPDT']","['self-compassion', 'depression', 'depression and anxiety symptoms', 'remission', 'anxiety', 'anxiety severity, emotion regulation, self-compassion, and an additional depression measure', 'self-reported depressive symptoms, measured with the Quick Inventory of Depressive Symptomatology for Adolescents (QIDS-A17-SR', 'emotion regulation during treatment', 'emotion regulation']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3266254', 'cui_str': 'Referred by self (finding)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C4720917', 'cui_str': 'Quick inventory of depressive symptomatology (assessment scale)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",76.0,0.208104,"IPDT was also significantly more effective in reducing anxiety (d=0.78, P<.001) and increasing emotion regulation (d=0.97, P<.001) and self-compassion (d=0.65, P=.003).","[{'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Lindqvist', 'Affiliation': 'Department of Psychology, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Mechler', 'Affiliation': 'Department of Psychology, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Carlbring', 'Affiliation': 'Department of Psychology, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lilliengren', 'Affiliation': 'Ersta Sköndal Bräcke University College, Stockholm, Sweden.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Falkenström', 'Affiliation': 'Department of Behavioural Sciences and Learning, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Andersson', 'Affiliation': 'Department of Behavioural Sciences and Learning, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Johansson', 'Affiliation': 'Department of Psychology, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Edbrooke-Childs', 'Affiliation': 'Evidence Based Practice Unit, Anna Freud National Centre for Children and Families, London, United Kingdom.'}, {'ForeName': 'Hanne-Sofie J', 'Initials': 'HJ', 'LastName': 'Dahl', 'Affiliation': 'Vestfold Hospital Trust, Oslo, Norway.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Lindert Bergsten', 'Affiliation': 'Department of Psychology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Midgley', 'Affiliation': 'Department of Clinical, Educational and Health Psychology, University College London, London, United Kingdom.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Sandell', 'Affiliation': 'Department of Psychology, Lund University, Lund, Sweden.'}, {'ForeName': 'Agneta', 'Initials': 'A', 'LastName': 'Thorén', 'Affiliation': 'The Erica Foundation, Stockholm, Sweden.'}, {'ForeName': 'Naira', 'Initials': 'N', 'LastName': 'Topooco', 'Affiliation': 'Department of Behavioural Sciences and Learning, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Randi', 'Initials': 'R', 'LastName': 'Ulberg', 'Affiliation': 'Division of Mental Health and Addiction, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Philips', 'Affiliation': 'Department of Psychology, Stockholm University, Stockholm, Sweden.'}]",Journal of medical Internet research,['10.2196/18047']
183,32071051,"In Vitro  Activity of Ceftazidime-Avibactam against Isolates from Respiratory and Blood Specimens from Patients with Nosocomial Pneumonia, Including Ventilator-Associated Pneumonia, in a Phase 3 Clinical Trial.","Nosocomial pneumonia (NP), including ventilator-associated pneumonia (VAP), is increasingly associated with multidrug-resistant Gram-negative pathogens. This study describes the  in vitro  activity of ceftazidime-avibactam, ceftazidime, and relevant comparator agents against bacterial pathogens isolated from patients with NP, including VAP, enrolled in a ceftazidime-avibactam phase 3 trial. Gram-positive pathogens were included if coisolated with a Gram-negative pathogen.  In vitro  susceptibility was determined at a central laboratory using Clinical and Laboratory Standards Institute broth microdilution methods. Of 817 randomized patients, 457 (55.9%) had ≥1 Gram-negative bacterial pathogen(s) isolated at baseline, and 149 (18.2%) had ≥1 Gram-positive pathogen(s) coisolated. The most common isolated pathogens were  Klebsiella pneumoniae  (18.8%),  Pseudomonas aeruginosa  (15.8%), and  Staphylococcus aureus  (11.5%). Ceftazidime-avibactam was highly active  in vitro  against 370 isolates of  Enterobacteriaceae , with 98.6% susceptible (MIC 90 , 0.5 μg/ml) compared with 73.2% susceptible for ceftazidime (MIC 90 , >64 μg/ml). The percent susceptibility values for ceftazidime-avibactam and ceftazidime against 129  P. aeruginosa  isolates were 88.4% and 72.9% (MIC 90  values of 16 μg/ml and 64 μg/ml), respectively. Among ceftazidime-nonsusceptible Gram-negative isolates, ceftazidime-avibactam percent susceptibility values were 94.9% for 99  Enterobacteriaceae  and 60.0% for 35  P. aeruginosa  MIC 90  values for linezolid and vancomycin (permitted per protocol for Gram-positive coverage) were within their respective MIC susceptibility breakpoints against the Gram-positive pathogens isolated. This analysis demonstrates that ceftazidime-avibactam was active  in vitro  against the majority of  Enterobacteriaceae  and  P. aeruginosa  isolates from patients with NP, including VAP, in a phase 3 trial. (This study has been registered at ClinicalTrials.gov under identifier NCT01808092.).",2020,"Ceftazidime-avibactam was highly active  in vitro  against 370 isolates of  Enterobacteriaceae , with 98.6% susceptible (","['patients with NP, including VAP, enrolled in a', 'Of 817 randomized patients, 457 (55.9%) had ≥1 Gram-negative bacterial pathogen isolated at baseline, and 149 (18.2%) had ≥1 Gram-positive pathogen co-isolated', 'Patients with Nosocomial Pneumonia, including Ventilator-Associated Pneumonia']","['ceftazidime', 'ceftazidime (MIC 90  ', 'ceftazidime-avibactam, ceftazidime', 'linezolid and vancomycin', 'Ceftazidime-avibactam', 'Ceftazidime-Avibactam', 'ceftazidime-avibactam and ceftazidime', 'ceftazidime-avibactam']","['Nosocomial pneumonia (NP), including ventilator-associated pneumonia (VAP']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439208', 'cui_str': 'gram (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0450254', 'cui_str': 'Pathogen'}, {'cui': 'C0205409', 'cui_str': 'Isolated (qualifier value)'}, {'cui': 'C4517610', 'cui_str': '18.2'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1443237', 'cui_str': 'Nosocomial Pneumonia'}, {'cui': 'C0087153', 'cui_str': 'Ventilators'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}]","[{'cui': 'C0007559', 'cui_str': 'Ceftazidime'}, {'cui': 'C0427978', 'cui_str': 'Minimum Inhibitory Concentration'}, {'cui': 'C3656596', 'cui_str': 'avibactam / Ceftazidime'}, {'cui': 'C0663241', 'cui_str': 'linezolid'}, {'cui': 'C0042313', 'cui_str': 'Vancomycin'}]","[{'cui': 'C1443237', 'cui_str': 'Nosocomial Pneumonia'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0087153', 'cui_str': 'Ventilators'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}]",817.0,0.30059,"Ceftazidime-avibactam was highly active  in vitro  against 370 isolates of  Enterobacteriaceae , with 98.6% susceptible (","[{'ForeName': 'Gregory G', 'Initials': 'GG', 'LastName': 'Stone', 'Affiliation': 'Pfizer, Groton, Connecticut, USA GregoryG.Stone@pfizer.com.'}, {'ForeName': 'Patricia A', 'Initials': 'PA', 'LastName': 'Bradford', 'Affiliation': 'AstraZeneca Pharmaceuticals, Waltham, Massachusetts, USA.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Tawadrous', 'Affiliation': 'Pfizer, Groton, Connecticut, USA.'}, {'ForeName': 'Dianna', 'Initials': 'D', 'LastName': 'Taylor', 'Affiliation': 'TaylorMade Health, Ltd, Warrington, United Kingdom.'}, {'ForeName': 'Mary Jane', 'Initials': 'MJ', 'LastName': 'Cadatal', 'Affiliation': 'Pfizer, Manila, Philippines.'}, {'ForeName': 'Zhangjing', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'AstraZeneca, Shanghai, China.'}, {'ForeName': 'Joseph W', 'Initials': 'JW', 'LastName': 'Chow', 'Affiliation': 'Pfizer, Collegeville, Pennsylvania, USA.'}]",Antimicrobial agents and chemotherapy,['10.1128/AAC.02356-19']
184,32187767,"""Take an HIV Test Kit Home"": A Pilot Randomized Controlled Trial Among HIV High-risk Urban ED Patients.",,2020,2-4  Developing methods to increase engagement for routine testing for them remains a top priority in the national HIV preventive strategy.,"['people who inject drugs, men who have sex with men (MSM), and heterosexuals at increased risk, should be screened for HIV at least once annually and sexually active MSM from testing every 3-6 months', 'HIV High-Risk Urban ED Patients']",[],[],"[{'cui': 'C4521936', 'cui_str': 'Inject (administration method)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C1527360', 'cui_str': 'Heterosexuals'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0241028', 'cui_str': 'Sexually active (finding)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",[],[],,0.214878,2-4  Developing methods to increase engagement for routine testing for them remains a top priority in the national HIV preventive strategy.,"[{'ForeName': 'Angie S', 'Initials': 'AS', 'LastName': 'Kim', 'Affiliation': 'From the, Department of Emergency Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Anuj V', 'Initials': 'AV', 'LastName': 'Patel', 'Affiliation': 'From the, Department of Emergency Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Charlotte A', 'Initials': 'CA', 'LastName': 'Gaydos', 'Affiliation': 'the, Department of Medicine, Division of Infectious Diseases, School of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Jett-Goheen', 'Affiliation': 'the, Department of Medicine, Division of Infectious Diseases, School of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Samuel M', 'Initials': 'SM', 'LastName': 'Abrams', 'Affiliation': 'From the, Department of Emergency Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Carl A', 'Initials': 'CA', 'LastName': 'Latkin', 'Affiliation': 'and the, Department of Health, Behavior and Society, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Rothman', 'Affiliation': 'From the, Department of Emergency Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Yu-Hsiang', 'Initials': 'YH', 'LastName': 'Hsieh', 'Affiliation': 'From the, Department of Emergency Medicine, Johns Hopkins University, Baltimore, MD, USA.'}]",Academic emergency medicine : official journal of the Society for Academic Emergency Medicine,['10.1111/acem.13968']
185,32092760,Modulation of the antidepressant effects of ketamine by the mTORC1 inhibitor rapamycin.,"Twenty-four hours after administration, ketamine exerts rapid and robust antidepressant effects that are thought to be mediated by activation of the mechanistic target of rapamycin complex 1 (mTORC1). To test this hypothesis, depressed patients were pretreated with rapamycin, an mTORC1 inhibitor, prior to receiving ketamine. Twenty patients suffering a major depressive episode were randomized to pretreatment with oral rapamycin (6 mg) or placebo 2 h prior to the intravenous administration of ketamine 0.5 mg/kg in a double-blind cross-over design with treatment days separated by at least 2 weeks. Depression severity was assessed using Montgomery-Åsberg Depression Rating Scale (MADRS). Rapamycin pretreatment did not alter the antidepressant effects of ketamine at the 24-h timepoint. Over the subsequent 2-weeks, we found a significant treatment by time interaction (F (8,245)  = 2.02, p = 0.04), suggesting a prolongation of the antidepressant effects of ketamine by rapamycin. Two weeks following ketamine administration, we found higher response (41%) and remission rates (29%) following rapamycin + ketamine compared to placebo + ketamine (13%, p = 0.04, and 7%, p = 0.003, respectively). In summary, single dose rapamycin pretreatment failed to block the antidepressant effects of ketamine, but it prolonged ketamine's antidepressant effects. This observation raises questions about the role of systemic vs. local blockade of mTORC1 in the antidepressant effects of ketamine, provides preliminary evidence that rapamycin may extend the benefits of ketamine, and thereby potentially sheds light on mechanisms that contribute to depression relapse after ketamine administration.",2020,"Two weeks following ketamine administration, we found higher response (41%) and remission rates (29%) following rapamycin + ketamine compared to placebo + ketamine (13%, p = 0.04, and 7%, p = 0.003, respectively).",['Twenty patients suffering a major depressive episode'],"['rapamycin\u2009+\u2009ketamine', 'placebo', 'ketamine', 'Rapamycin', 'rapamycin', 'placebo\u2009+\u2009ketamine', 'rapamycin, an mTORC1 inhibitor, prior to receiving ketamine', 'oral rapamycin']","['remission rates', 'Montgomery-Åsberg Depression Rating Scale (MADRS', 'Depression severity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0349217', 'cui_str': 'Depressive episode'}]","[{'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3888046', 'cui_str': 'mTORC1 Complex'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",,0.0810233,"Two weeks following ketamine administration, we found higher response (41%) and remission rates (29%) following rapamycin + ketamine compared to placebo + ketamine (13%, p = 0.04, and 7%, p = 0.003, respectively).","[{'ForeName': 'Chadi G', 'Initials': 'CG', 'LastName': 'Abdallah', 'Affiliation': 'National Center for PTSD - Clinical Neurosciences Division, US Department of Veterans Affairs, West Haven, CT, USA. chadi.abdallah@yale.edu.'}, {'ForeName': 'Lynnette A', 'Initials': 'LA', 'LastName': 'Averill', 'Affiliation': 'National Center for PTSD - Clinical Neurosciences Division, US Department of Veterans Affairs, West Haven, CT, USA.'}, {'ForeName': 'Ralitza', 'Initials': 'R', 'LastName': 'Gueorguieva', 'Affiliation': 'Department of Biostatistics, Yale University School of Public Health, New Haven, CT, USA.'}, {'ForeName': 'Selin', 'Initials': 'S', 'LastName': 'Goktas', 'Affiliation': 'National Center for PTSD - Clinical Neurosciences Division, US Department of Veterans Affairs, West Haven, CT, USA.'}, {'ForeName': 'Prerana', 'Initials': 'P', 'LastName': 'Purohit', 'Affiliation': 'National Center for PTSD - Clinical Neurosciences Division, US Department of Veterans Affairs, West Haven, CT, USA.'}, {'ForeName': 'Mohini', 'Initials': 'M', 'LastName': 'Ranganathan', 'Affiliation': 'Departments of Psychiatry, Neuroscience, and Psychology Yale University, New Haven, CT, USA.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Sherif', 'Affiliation': 'Departments of Psychiatry, Neuroscience, and Psychology Yale University, New Haven, CT, USA.'}, {'ForeName': 'Kyung-Heup', 'Initials': 'KH', 'LastName': 'Ahn', 'Affiliation': 'Departments of Psychiatry, Neuroscience, and Psychology Yale University, New Haven, CT, USA.'}, {'ForeName': 'Deepak Cyril', 'Initials': 'DC', 'LastName': ""D'Souza"", 'Affiliation': 'Departments of Psychiatry, Neuroscience, and Psychology Yale University, New Haven, CT, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Formica', 'Affiliation': 'Department of Internal Medicine, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Southwick', 'Affiliation': 'National Center for PTSD - Clinical Neurosciences Division, US Department of Veterans Affairs, West Haven, CT, USA.'}, {'ForeName': 'Ronald S', 'Initials': 'RS', 'LastName': 'Duman', 'Affiliation': 'National Center for PTSD - Clinical Neurosciences Division, US Department of Veterans Affairs, West Haven, CT, USA.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Sanacora', 'Affiliation': 'National Center for PTSD - Clinical Neurosciences Division, US Department of Veterans Affairs, West Haven, CT, USA.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Krystal', 'Affiliation': 'National Center for PTSD - Clinical Neurosciences Division, US Department of Veterans Affairs, West Haven, CT, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0644-9']
186,32094127,Comparison of Treatment Outcomes between Analysis Populations in the RESTORE-IMI 1 Phase 3 Trial of Imipenem-Cilastatin-Relebactam versus Colistin plus Imipenem-Cilastatin in Patients with Imipenem-Nonsusceptible Bacterial Infections.,"The RESTORE-IMI 1 phase 3 trial demonstrated the efficacy and safety of imipenem-cilastatin (IMI) combined with relebactam (REL) for treating imipenem-nonsusceptible infections. The objective of this analysis was to compare the outcomes among patients meeting eligibility requirements based on central laboratory susceptibility versus local laboratory susceptibility. Patients with serious infections caused by imipenem-nonsusceptible, colistin-susceptible, and imipenem-REL-susceptible pathogens were randomized 2:1 to IMI-REL plus placebo or colistin plus IMI for 5 to 21 days. The primary endpoint was a favorable overall response. Key endpoints included the clinical response and all-cause mortality. We compared outcomes between the primary microbiological modified intent-to-treat (mMITT) population, where eligibility was based on central laboratory susceptibility testing, and the supplemental mMITT (SmMITT) population, where eligibility was based on local, site-level testing. The SmMITT ( n  = 41) and MITT ( n  = 31) populations had similar baseline characteristics, including sex, age, illness severity, and renal function. In both analysis populations, favorable overall response rates in the IMI-REL treatment group were >70%. Favorable clinical response rates at day 28 were 71.4% for IMI-REL and 40.0% for colistin plus IMI in the mMITT population, whereas they were 75.0% for IMI-REL and 53.8% for colistin plus IMI in the SmMITT population. Day 28 all-cause mortality rates were 9.5% for IMI-REL and 30.0% for colistin plus IMI in the mMITT population, whereas they were 10.7% for IMI-REL and 23.1% for colistin plus IMI in the SmMITT population. The outcomes in the SmMITT population were generally consistent with those in the mMITT population, suggesting that outcomes may be applicable to the real-world use of IMI-REL for treating infections caused by imipenem-nonsusceptible Gram-negative pathogens. (This study has been registered at ClinicalTrials.gov under identifier NCT02452047.).",2020,Day 28 all-cause mortality rates were 9.5% for IMI/REL and 30.0% for colistin plus IMI in mMITT compared with 10.7% for IMI/REL and 23.1% for colistin plus IMI in SmMITT.,"['patients meeting eligibility requirements based on central laboratory susceptibility versus local laboratory susceptibility', 'Patients With Imipenem-Nonsusceptible Bacterial Infections', 'Patients with serious infections caused by imipenem-nonsusceptible, colistin-susceptible, and imipenem/REL-susceptible pathogens']","['IMI/REL plus placebo or colistin plus IMI', 'Imipenem/Cilastatin/Relebactam Versus Colistin Plus Imipenem/Cilastatin', 'primary microbiological modified intent-to-treat population (mMITT', 'imipenem/cilastatin (IMI) combined with relebactam (REL']","['efficacy and safety', 'clinical response and all-cause mortality', 'Favorable clinical response rates', 'favorable overall response', 'mortality rates', 'overall response rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1264642', 'cui_str': 'Susceptibility (property) (qualifier value)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0020933', 'cui_str': 'Imipenem'}, {'cui': 'C0004623', 'cui_str': 'Bacterial Infections'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0009316', 'cui_str': 'Colistin'}, {'cui': 'C0231204', 'cui_str': 'Susceptible (qualifier value)'}, {'cui': 'C0450254', 'cui_str': 'Pathogen'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0009316', 'cui_str': 'Colistin'}, {'cui': 'C0020933', 'cui_str': 'Imipenem'}, {'cui': 'C0008777', 'cui_str': 'Cilastatin'}, {'cui': 'C4317244'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}]",,0.0957439,Day 28 all-cause mortality rates were 9.5% for IMI/REL and 30.0% for colistin plus IMI in mMITT compared with 10.7% for IMI/REL and 23.1% for colistin plus IMI in SmMITT.,"[{'ForeName': 'Keith S', 'Initials': 'KS', 'LastName': 'Kaye', 'Affiliation': 'University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Helen W', 'Initials': 'HW', 'LastName': 'Boucher', 'Affiliation': 'Tufts Medical Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Brown', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Aggrey', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Ireen', 'Initials': 'I', 'LastName': 'Khan', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Hee-Koung', 'Initials': 'HK', 'LastName': 'Joeng', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Tipping', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Jiejun', 'Initials': 'J', 'LastName': 'Du', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Young', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Joan R', 'Initials': 'JR', 'LastName': 'Butterton', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Paschke', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA amanda.paschke@merck.com.'}]",Antimicrobial agents and chemotherapy,['10.1128/AAC.02203-19']
187,31395900,Sex-Related Differences in Impact on Safety of Pharmacogenetic Profile for Colon Cancer Patients Treated with FOLFOX-4 or XELOX Adjuvant Chemotherapy.,"Polymorphisms contribute to inter-individual differences and show a promising predictive role for chemotherapy-related toxicity in colon cancer (CC). TOSCA is a multicentre, randomized, non-inferiority, phase III study conducted in high-risk stage II/stage III CC patients treated with 6 vs 3 months of FOLFOX-4 or XELOX adjuvant chemotherapy. During this post-hoc analysis, 218 women and 294 men were genotyped for 17 polymorphisms: TYMS (rs34743033, rs2853542, rs11280056), MTHFR (rs1801133, rs1801131), ERCC1 (rs11615), XRCC1 (rs25487), XRCC3 (rs861539), XPD (rs1799793, rs13181), GSTP1 (rs1695), GSTT1/GSTM1 (deletion +/-), ABCC1 (rs2074087), and ABCC2 (rs3740066, rs1885301, rs4148386). The aim was to assess the interaction between these polymorphisms and sex, on safety in terms of time to grade ≥3 haematological (TTH), grade ≥3 gastrointestinal (TTG) and grade ≥2 neurological (TTN) toxicity. Interactions were detected on TTH for rs1801133 and rs1799793, on TTG for rs13181 and on TTN for rs11615. Rs1799793 GA genotype (p = 0.006) and A allele (p = 0.009) shortened TTH in men. In women, the rs11615 CC genotype worsened TTN (co-dominant model p = 0.008, recessive model p = 0.003) and rs13181 G allele improved the TTG (p = 0.039). Differences between the two sexes in genotype distribution of rs1885301 (p = 0.020) and rs4148386 (p = 0.005) were found. We highlight that polymorphisms could be sex-specific biomarkers. These results, however, need to be confirmed in additional series.",2019,"In women, the rs11615 CC genotype worsened TTN (co-dominant model p = 0.008, recessive model p = 0.003) and rs13181 G allele improved the TTG (p = 0.039).","['218 women and 294 men', 'Colon Cancer Patients Treated with FOLFOX-4 or XELOX Adjuvant Chemotherapy']","['FOLFOX-4 or XELOX adjuvant chemotherapy', 'TOSCA']","['XRCC1 (rs25487), XRCC3 (rs861539), XPD (rs1799793, rs13181), GSTP1 (rs1695), GSTT1/GSTM1 (deletion\u2009', 'time to grade ≥3 haematological (TTH), grade ≥3 gastrointestinal (TTG) and grade ≥2 neurological (TTN) toxicity', ' ABCC1 (rs2074087), and ABCC2 (rs3740066, rs1885301, rs4148386']","[{'cui': 'C4517647', 'cui_str': 'Two hundred and eighteen'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0007102', 'cui_str': 'Cancer of Colon'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C1956962', 'cui_str': 'XELOX'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}]","[{'cui': 'C1956962', 'cui_str': 'XELOX'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}]","[{'cui': 'C1442161', 'cui_str': 'Deletion (morphologic abnormality)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",218.0,0.0590836,"In women, the rs11615 CC genotype worsened TTN (co-dominant model p = 0.008, recessive model p = 0.003) and rs13181 G allele improved the TTG (p = 0.039).","[{'ForeName': 'Annamaria', 'Initials': 'A', 'LastName': 'Ruzzo', 'Affiliation': 'Department of Biomolecular Sciences, Università degli Studi di Urbino ""Carlo Bo"", Urbino, Italy. annamaria.ruzzo@uniurb.it.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Graziano', 'Affiliation': 'Azienda Ospedaliera ""Ospedali Riuniti Marche Nord"", Pesaro, Italy. graziano.fda@yahoo.com.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Galli', 'Affiliation': 'Laboratory of Methodology for Clinical research, Department of Oncology, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Galli', 'Affiliation': 'Laboratory of Methodology for Clinical research, Department of Oncology, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy.'}, {'ForeName': 'Eliana', 'Initials': 'E', 'LastName': 'Rulli', 'Affiliation': 'Laboratory of Methodology for Clinical research, Department of Oncology, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Lonardi', 'Affiliation': 'Istituto Oncologico Veneto IOV - IRCCS, Padova, Italy.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Ronzoni', 'Affiliation': 'Ospedale San Raffaele, Milano, Italy.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Massidda', 'Affiliation': 'Azienda Ospedaliera Universitaria di Cagliari, P.O. Monserrato, Monserrato, Italy.'}, {'ForeName': 'Vittorina', 'Initials': 'V', 'LastName': 'Zagonel', 'Affiliation': 'Istituto Oncologico Veneto IOV - IRCCS, Padova, Italy.'}, {'ForeName': 'Nicoletta', 'Initials': 'N', 'LastName': 'Pella', 'Affiliation': 'Azienda Ospedaliera S. Maria della Misericordia, Udine, Italy.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Mucciarini', 'Affiliation': 'Ospedale ""B. Ramazzini"", Carpi, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Labianca', 'Affiliation': 'Ospedale Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Maria Teresa', 'Initials': 'MT', 'LastName': 'Ionta', 'Affiliation': 'Azienda Ospedaliera Universitaria di Cagliari, P.O. Monserrato, Monserrato, Italy.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Bagaloni', 'Affiliation': 'Department of Biomolecular Sciences, Università degli Studi di Urbino ""Carlo Bo"", Urbino, Italy.'}, {'ForeName': 'Enzo', 'Initials': 'E', 'LastName': 'Veltri', 'Affiliation': 'Ospedale di Gaeta ASL Latina, Gaeta, Italy.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Sozzi', 'Affiliation': 'Ospedale degli Infermi di Biella, Biella, Italy.'}, {'ForeName': 'Sandro', 'Initials': 'S', 'LastName': 'Barni', 'Affiliation': 'Ospedale ""Treviglio-Caravaggio"", Treviglio, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Ricci', 'Affiliation': 'Ospedale San Raffaele, Milano, Italy.'}, {'ForeName': 'Luisa', 'Initials': 'L', 'LastName': 'Foltran', 'Affiliation': 'Azienda Ospedaliera Santa Maria degli Angeli, Pordenone, Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Nicolini', 'Affiliation': 'Azienda Ospedaliera Ospedale ""Cervesi"", Cattolica, Italy.'}, {'ForeName': 'Edoardo', 'Initials': 'E', 'LastName': 'Biondi', 'Affiliation': 'Ospedale ""F. Renzetti"", Lanciano, Italy.'}, {'ForeName': 'Annalisa', 'Initials': 'A', 'LastName': 'Bramati', 'Affiliation': 'Azienda Ospedaliera Fatebenefratelli, Milano, Italy.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Turci', 'Affiliation': 'AUSL Ospedale di Ravenna, Ravenna, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Lazzarelli', 'Affiliation': 'Azienda Ospedaliera di Cremona, Cremona, Italy.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Verusio', 'Affiliation': 'Ospedale di Saronno, Saronno, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Bergamo', 'Affiliation': 'Istituto Oncologico Veneto IOV - IRCCS, Padova, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Sobrero', 'Affiliation': 'Azienda Ospedaliera ""Ospedale San Martino"", Genova, Italy.'}, {'ForeName': 'Luciano', 'Initials': 'L', 'LastName': 'Frontini', 'Affiliation': 'Fondazione GISCAD, Vanzago, Italy.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Magnani', 'Affiliation': 'Department of Biomolecular Sciences, Università degli Studi di Urbino ""Carlo Bo"", Urbino, Italy.'}]",Scientific reports,['10.1038/s41598-019-47627-1']
188,31245006,Effect of dose of behavioral weight loss treatment on glycemic control in adults with prediabetes.,"Objective


This study examined the effects of three doses of behavioral weight loss treatment, compared with a nutrition education control group, on changes in glycemic control in individuals with obesity and prediabetes.
Research design and methods


The study included 287 adults (77% female, 81% White; mean (SD) age=54.1 (10.5) years, body mass index=36.3 (3.9) kg/m 2 , and hemoglobin A1c (HbA1c)=5.9 (0.2%)). Participants were randomized to one of three behavioral treatment doses (high=24 sessions, moderate=16 sessions, or low=8 sessions) or to an education group (control=8 sessions). Changes in HbA1c, fasting glucose, and body weight were assessed from baseline to 6 months.
Results


Mean (99.2% credible interval (CI)) reductions in HbA1c were 0.11% (0.07% to 0.16%), 0.08% (0.03% to 0.13%), 0.03% (-0.01% to 0.07%), and 0.02% (-0.02% to 0.07%), for the high, moderate, low, and control conditions, respectively. Mean (CI) reductions in fasting blood glucose were 0.26 mmol/L (0.14 to 0.39), 0.09 mmol/L (0 to 0.19), 0.01 mmol/L (-0.07 to 0.09), and 0.04 mmol/L (-0.03 to 0.12) for the high, moderate, low, and control conditions, respectively. The high-dose treatment produced significantly greater reductions in HbA1c and fasting blood glucose than the low-dose and control conditions (posterior probabilities (pp)<0.001); no other significant between-group differences were observed. Mean (CI) reductions in body weight were 10.91 kg (9.30 to 12.64), 10.08 kg (8.38 to 11.72), 6.35 kg (5.19 to 7.69), and 3.82 kg (3.04 to 4.54) for the high, moderate, low, and control conditions, respectively. All between-group differences in 6-month weight change were significant (pps<0.001) except for the high-dose versus moderate-dose comparison.
Conclusion


For adults with obesity and prediabetes a high dose of behavioral treatment involving 24 sessions over 6 months may be needed to optimize improvements in glycemic control.
Trial registration number


NCT00912652.",2019,The high-dose treatment produced significantly greater reductions in HbA1c and fasting blood glucose than the low-dose and control conditions (posterior probabilities (pp)<0.001); no other significant between-group differences were observed.,"['287 adults (77% female, 81% White; mean (SD) age=54.1 (10.5) years, body mass index=36.3 (3.9) kg/m 2 , and hemoglobin A1c', 'adults with prediabetes', 'adults with obesity', 'individuals with obesity and prediabetes']",['behavioral weight loss treatment'],"['6-month weight change', 'HbA1c and fasting blood glucose', 'Mean (CI) reductions in body weight', 'Mean (CI) reductions in fasting blood glucose', 'glycemic control', 'Changes in HbA1c, fasting glucose, and body weight']","[{'cui': 'C4517682', 'cui_str': '287 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517521', 'cui_str': '10.5'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C4517698', 'cui_str': '3.9 (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0362046', 'cui_str': 'Prediabetes'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}]",287.0,0.0248729,The high-dose treatment produced significantly greater reductions in HbA1c and fasting blood glucose than the low-dose and control conditions (posterior probabilities (pp)<0.001); no other significant between-group differences were observed.,"[{'ForeName': 'Viviana', 'Initials': 'V', 'LastName': 'Bauman', 'Affiliation': 'Department of Clinical and Health Psychology, University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'Aviva H', 'Initials': 'AH', 'LastName': 'Ariel-Donges', 'Affiliation': 'Department of Clinical and Health Psychology, University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'Eliza L', 'Initials': 'EL', 'LastName': 'Gordon', 'Affiliation': 'Department of Clinical and Health Psychology, University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Daniels', 'Affiliation': 'Department of Statistics, University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'Dandan', 'Initials': 'D', 'LastName': 'Xu', 'Affiliation': 'Department of Statistics and Data Sciences, University of Texas at Austin, Austin, Texas, USA.'}, {'ForeName': 'Kathryn M', 'Initials': 'KM', 'LastName': 'Ross', 'Affiliation': 'Department of Clinical and Health Psychology, University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'Marian C', 'Initials': 'MC', 'LastName': 'Limacher', 'Affiliation': 'Department of Medicine, University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Perri', 'Affiliation': 'Department of Clinical and Health Psychology, University of Florida, Gainesville, Florida, USA.'}]",BMJ open diabetes research & care,['10.1136/bmjdrc-2019-000653']
189,32316074,The effect of an intervention program on the knowledge and attitudes among medical staff regarding adverse drug reaction reporting.,"PURPOSE


Adverse drug reactions (ADRs) are a growing important public health problem; however, underreporting of ADRs is very common. The aim of the current study was to explore the effect of an intervention program on the knowledge and attitudes among physicians and nurses regarding ADRs reporting.
METHODS


A multicentre study consisted of three phases: filling out a questionnaire; an intervention program; filling out the same questionnaire again. The intervention program consisted of posters, lectures, and distant electronic learning. The questionnaire contained questions about personal/professional demographic variables, and statements regarding knowledge and attitudes regarding ADR reporting.
RESULTS


The data revealed that the intervention program significantly elevated the ""Objective knowledge"" (P < 0.01) and ""Practical knowledge"" (P < 0.02) score as compared to the control group, while no significant differences were found regarding ""Acquired knowledge"" (P = 0.14). Seniority (P = 0.01) and experience in internal medicine (P = 0.05) were demonstrated as significant factors determining the knowledge of the staff. Obligation was the main motive for reporting in 80% of participants. After the intervention, no differences were found in the ""Attitude related to the motive for reporting"" or ""Attitude related to the commitment to report"", between the two groups. However, ""Attitude related to the need to report"" score significantly improved after the intervention (P = 0.04).
CONCLUSIONS


The intervention program increased knowledge and attitudes regarding ADRs reports. Seniority had the most effect on the influence of the intervention program. The data from this study encourages the necessity to hold ongoing intervention programs in order to improve ADRs reporting rate.",2020,"However, ""Attitude related to the need to report"" score significantly improved after the intervention (P = 0.04).
",['physicians and nurses regarding ADRs reporting'],"['intervention program', 'posters, lectures, and distant electronic learning']","['Acquired knowledge', ' score', 'Objective knowledge', 'Attitude related to the motive for reporting"" or ""Attitude', 'knowledge and attitudes regarding ADRs reports', 'Practical knowledge']","[{'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0684224', 'cui_str': 'Report'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0376675', 'cui_str': 'Posters'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0443203', 'cui_str': 'Distant'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0439661', 'cui_str': 'Acquired'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0684224', 'cui_str': 'Report'}]",,0.0155771,"However, ""Attitude related to the need to report"" score significantly improved after the intervention (P = 0.04).
","[{'ForeName': 'Miri Potlog', 'Initials': 'MP', 'LastName': 'Shchory', 'Affiliation': 'Department of Public Health, Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer Sheva, Israel.'}, {'ForeName': 'Lee Hilery', 'Initials': 'LH', 'LastName': 'Goldstein', 'Affiliation': 'Clinical Pharmacology Unit, Haemek Medical Center, Afula, Affiliated to The Bruce Rapapport School of Medicine, Technion, Haifa, Israel.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Arcavi', 'Affiliation': 'Clinical Pharmacology Unit, Kaplan Medical Center, Hebrew University and Hadassah Medical School, Jerusalem, Israel.'}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Shihmanter', 'Affiliation': 'Clinical Pharmacology Unit, Kaplan Medical Center, Hebrew University and Hadassah Medical School, Jerusalem, Israel.'}, {'ForeName': 'Matitiahu', 'Initials': 'M', 'LastName': 'Berkovitch', 'Affiliation': 'Clinical Pharmacology Unit, Shamir Medical Center (Assaf Harofeh), Zerifin, Affiliated to Sackler School of Medicine, Tel-Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Amalia', 'Initials': 'A', 'LastName': 'Levy', 'Affiliation': 'Department of Public Health, Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer Sheva, Israel.'}]",Pharmacoepidemiology and drug safety,['10.1002/pds.5013']
190,30621517,The effects of a multispecies probiotic supplement on inflammatory markers and episodic and chronic migraine characteristics: A randomized double-blind controlled trial.,"BACKGROUND


The current study was designed to assess the effect of supplementation with a 14-strain probiotic mixture on episodic and chronic migraine characteristics.
METHODS


Forty episodic and 39 chronic migraine patients who completed this randomized double-blind controlled trial received two capsules of multispecies probiotic or placebo. The migraine severity was assessed by visual analog scale (VAS). The number of abortive drugs consumed, migraine days, frequency and duration of attacks were recorded on paper-based headache diaries. Serum tumor necrosis factor alpha (TNF-α) and C- reactive protein (CRP) levels were measured at baseline and the end of the intervention.
RESULTS


After a 10-week intervention, among episodic migraineurs the mean frequency of migraine attacks significantly reduced in the probiotic group compare to the placebo group (mean change: -2.64 vs. 0.06; respectively, p < 0.001). A significant reduction was also evident in the migraine severity (mean decrease: -2.14 in the probiotic group and 0.11 in the placebo group; p < 0.001). Episodic migraineurs who received the probiotic also showed significant reduction in abortive drug usage per week (mean change: -0.72; p < 0.001) compare to baseline, while there was no significant changes within the placebo group. In chronic migraine patients, after an 8-week intervention, the mean frequency of migraine attacks significantly reduced in the probiotic compared to the placebo group (mean change: -9.67 vs. -0.22; p ≤ 0.001). In contrast to the placebo, probiotic supplementation significantly decreased the severity (mean changes: -2.69; p ≤ 0.001), duration (mean changes: -0.59; p ≤ 0.034) of attacks and the number of abortive drugs taken per day (mean changes: -1.02; p < 0.001), in chronic migraine patients. We failed to detect any significant differences in the serum levels of inflammatory markers at the end of the study either in chronic or in episodic migraineurs.
DISCUSSION


The results of this study showed that the 14-strain probiotic mixture could be an effective and beneficial supplement to improve migraine headache in both chronic and episodic migraineurs. Further research is required to confirm our observations.",2019,"After a 10-week intervention, among episodic migraineurs the mean frequency of migraine attacks significantly reduced in the probiotic group compare to the placebo group (mean change:","['Episodic migraineurs', 'Forty episodic and 39 chronic migraine patients']","['14-strain probiotic mixture', 'placebo', 'multispecies probiotic or placebo', 'multispecies probiotic supplement', 'placebo, probiotic supplementation']","['abortive drug usage', 'serum levels of inflammatory markers', 'migraine severity', 'migraine headache', 'Serum tumor necrosis factor alpha (TNF-α) and C- reactive protein (CRP) levels', 'mean frequency of migraine attacks', 'visual analog scale (VAS', 'severity (mean changes', 'number of abortive drugs consumed, migraine days, frequency and duration of attacks', 'inflammatory markers and episodic and chronic migraine characteristics']","[{'cui': 'C1455761', 'cui_str': 'Episodic (qualifier value)'}, {'cui': 'C1960870', 'cui_str': 'Chronic migraine'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0439962', 'cui_str': 'Mixture (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0457083', 'cui_str': 'Usage (attribute)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C1304680', 'cui_str': 'Attack (finding)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1455761', 'cui_str': 'Episodic (qualifier value)'}, {'cui': 'C1960870', 'cui_str': 'Chronic migraine'}]",40.0,0.255318,"After a 10-week intervention, among episodic migraineurs the mean frequency of migraine attacks significantly reduced in the probiotic group compare to the placebo group (mean change:","[{'ForeName': 'Fahimeh', 'Initials': 'F', 'LastName': 'Martami', 'Affiliation': '1 Department of Clinical Nutrition and Dietetics, Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mansoureh', 'Initials': 'M', 'LastName': 'Togha', 'Affiliation': '2 Headache Department, Iranian Center of Neurological Research, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Seifishahpar', 'Affiliation': '1 Department of Clinical Nutrition and Dietetics, Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Zeinab', 'Initials': 'Z', 'LastName': 'Ghorbani', 'Affiliation': '2 Headache Department, Iranian Center of Neurological Research, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Ansari', 'Affiliation': '4 The University of California, San Diego, CA, USA.'}, {'ForeName': 'Tahereh', 'Initials': 'T', 'LastName': 'Karimi', 'Affiliation': '1 Department of Clinical Nutrition and Dietetics, Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Soodeh Razeghi', 'Initials': 'SR', 'LastName': 'Jahromi', 'Affiliation': '1 Department of Clinical Nutrition and Dietetics, Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Cephalalgia : an international journal of headache,['10.1177/0333102418820102']
191,32321387,Improved Glycemic Control in Adults With Serious Mental Illness and Diabetes With a Behavioral and Educational Intervention.,"OBJECTIVE


The purpose of this study was to evaluate a 16-week, reverse-integrated care (bringing primary care interventions/services into the psychiatric setting) behavioral and educational group intervention for individuals with serious mental illness and diabetes.
METHODS


The primary outcome was change in glycated hemoglobin (HbA1c). Secondary outcomes included body mass index (BMI), blood pressure, lipid levels, physical activity, diabetes knowledge, and self-care.
RESULTS


Thirty-five participants attended at least one group and were included in a modified intent-to-treat analysis. From baseline to week 16, HbA1c improved, from 7.5±1.6 to 7.1±1.4, p=0.01, and BMI improved, from 33.3±3.8 to 32.9±4.1, p<0.001, as did measures of diabetes knowledge and self-care. One-year follow-up in a subset of participants showed no evidence of rebound in HbA1c.
CONCLUSIONS


This 16-week behavioral and educational group intervention resulted in improvements in glycemic control, BMI, diabetes knowledge, and self-care. The results warrant larger-scale, controlled trial testing of this intervention to improve diabetes-related health outcomes in those with serious mental illness.",2020,"From baseline to week 16, HbA1c improved, from 7.5±1.6 to 7.1±1.4, p=0.01, and BMI improved, from 33.3±3.8 to 32.9±4.1, p<0.001, as did measures of diabetes knowledge and self-care.","['Adults With Serious Mental Illness and Diabetes With a Behavioral and Educational Intervention', 'individuals with serious mental illness and diabetes']","['behavioral and educational group intervention', 'reverse-integrated care (bringing primary care interventions/services into the psychiatric setting) behavioral and educational group intervention']","['diabetes knowledge and self-care', 'glycated hemoglobin (HbA1c', 'BMI', 'body mass index (BMI), blood pressure, lipid levels, physical activity, diabetes knowledge, and self-care', 'glycemic control, BMI, diabetes knowledge, and self-care']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332302', 'cui_str': 'Brought on by'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}]","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0428460', 'cui_str': 'Lipid level - finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",35.0,0.0533,"From baseline to week 16, HbA1c improved, from 7.5±1.6 to 7.1±1.4, p=0.01, and BMI improved, from 33.3±3.8 to 32.9±4.1, p<0.001, as did measures of diabetes knowledge and self-care.","[{'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Schnitzer', 'Affiliation': 'Center for Addiction Medicine, Department of Psychiatry (Schnitzer, Cather, Vilme, Dechert, Evins), Schizophrenia Research Program (Schnitzer, Cather, Freudenreich, MacLaurin, Vilme, Dechert, Evins), Diabetes Center, Department of Medicine (Wexler) and General Medicine Division, Department of Medicine (Thorndike), Department of Biostatistics (Potter), all at Massachusetts General Hospital (MGH), Boston; Erich Lindemann Mental Health Center, Freedom Trail Clinic, Boston (Freudenreich, MacLaurin).'}, {'ForeName': 'Corrine', 'Initials': 'C', 'LastName': 'Cather', 'Affiliation': 'Center for Addiction Medicine, Department of Psychiatry (Schnitzer, Cather, Vilme, Dechert, Evins), Schizophrenia Research Program (Schnitzer, Cather, Freudenreich, MacLaurin, Vilme, Dechert, Evins), Diabetes Center, Department of Medicine (Wexler) and General Medicine Division, Department of Medicine (Thorndike), Department of Biostatistics (Potter), all at Massachusetts General Hospital (MGH), Boston; Erich Lindemann Mental Health Center, Freedom Trail Clinic, Boston (Freudenreich, MacLaurin).'}, {'ForeName': 'Anne N', 'Initials': 'AN', 'LastName': 'Thorndike', 'Affiliation': 'Center for Addiction Medicine, Department of Psychiatry (Schnitzer, Cather, Vilme, Dechert, Evins), Schizophrenia Research Program (Schnitzer, Cather, Freudenreich, MacLaurin, Vilme, Dechert, Evins), Diabetes Center, Department of Medicine (Wexler) and General Medicine Division, Department of Medicine (Thorndike), Department of Biostatistics (Potter), all at Massachusetts General Hospital (MGH), Boston; Erich Lindemann Mental Health Center, Freedom Trail Clinic, Boston (Freudenreich, MacLaurin).'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Potter', 'Affiliation': 'Center for Addiction Medicine, Department of Psychiatry (Schnitzer, Cather, Vilme, Dechert, Evins), Schizophrenia Research Program (Schnitzer, Cather, Freudenreich, MacLaurin, Vilme, Dechert, Evins), Diabetes Center, Department of Medicine (Wexler) and General Medicine Division, Department of Medicine (Thorndike), Department of Biostatistics (Potter), all at Massachusetts General Hospital (MGH), Boston; Erich Lindemann Mental Health Center, Freedom Trail Clinic, Boston (Freudenreich, MacLaurin).'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Freudenreich', 'Affiliation': 'Center for Addiction Medicine, Department of Psychiatry (Schnitzer, Cather, Vilme, Dechert, Evins), Schizophrenia Research Program (Schnitzer, Cather, Freudenreich, MacLaurin, Vilme, Dechert, Evins), Diabetes Center, Department of Medicine (Wexler) and General Medicine Division, Department of Medicine (Thorndike), Department of Biostatistics (Potter), all at Massachusetts General Hospital (MGH), Boston; Erich Lindemann Mental Health Center, Freedom Trail Clinic, Boston (Freudenreich, MacLaurin).'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'MacLaurin', 'Affiliation': 'Center for Addiction Medicine, Department of Psychiatry (Schnitzer, Cather, Vilme, Dechert, Evins), Schizophrenia Research Program (Schnitzer, Cather, Freudenreich, MacLaurin, Vilme, Dechert, Evins), Diabetes Center, Department of Medicine (Wexler) and General Medicine Division, Department of Medicine (Thorndike), Department of Biostatistics (Potter), all at Massachusetts General Hospital (MGH), Boston; Erich Lindemann Mental Health Center, Freedom Trail Clinic, Boston (Freudenreich, MacLaurin).'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Vilme', 'Affiliation': 'Center for Addiction Medicine, Department of Psychiatry (Schnitzer, Cather, Vilme, Dechert, Evins), Schizophrenia Research Program (Schnitzer, Cather, Freudenreich, MacLaurin, Vilme, Dechert, Evins), Diabetes Center, Department of Medicine (Wexler) and General Medicine Division, Department of Medicine (Thorndike), Department of Biostatistics (Potter), all at Massachusetts General Hospital (MGH), Boston; Erich Lindemann Mental Health Center, Freedom Trail Clinic, Boston (Freudenreich, MacLaurin).'}, {'ForeName': 'Alyson', 'Initials': 'A', 'LastName': 'Dechert', 'Affiliation': 'Center for Addiction Medicine, Department of Psychiatry (Schnitzer, Cather, Vilme, Dechert, Evins), Schizophrenia Research Program (Schnitzer, Cather, Freudenreich, MacLaurin, Vilme, Dechert, Evins), Diabetes Center, Department of Medicine (Wexler) and General Medicine Division, Department of Medicine (Thorndike), Department of Biostatistics (Potter), all at Massachusetts General Hospital (MGH), Boston; Erich Lindemann Mental Health Center, Freedom Trail Clinic, Boston (Freudenreich, MacLaurin).'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Wexler', 'Affiliation': 'Center for Addiction Medicine, Department of Psychiatry (Schnitzer, Cather, Vilme, Dechert, Evins), Schizophrenia Research Program (Schnitzer, Cather, Freudenreich, MacLaurin, Vilme, Dechert, Evins), Diabetes Center, Department of Medicine (Wexler) and General Medicine Division, Department of Medicine (Thorndike), Department of Biostatistics (Potter), all at Massachusetts General Hospital (MGH), Boston; Erich Lindemann Mental Health Center, Freedom Trail Clinic, Boston (Freudenreich, MacLaurin).'}, {'ForeName': 'Anne Eden', 'Initials': 'AE', 'LastName': 'Evins', 'Affiliation': 'Center for Addiction Medicine, Department of Psychiatry (Schnitzer, Cather, Vilme, Dechert, Evins), Schizophrenia Research Program (Schnitzer, Cather, Freudenreich, MacLaurin, Vilme, Dechert, Evins), Diabetes Center, Department of Medicine (Wexler) and General Medicine Division, Department of Medicine (Thorndike), Department of Biostatistics (Potter), all at Massachusetts General Hospital (MGH), Boston; Erich Lindemann Mental Health Center, Freedom Trail Clinic, Boston (Freudenreich, MacLaurin).'}]","Psychiatric services (Washington, D.C.)",['10.1176/appi.ps.201900336']
192,30982348,"Efficacy and safety of erenumab (AMG334) in episodic migraine patients with prior preventive treatment failure: A subgroup analysis of a randomized, double-blind, placebo-controlled study.","BACKGROUND


Erenumab was effective and well tolerated in a pivotal clinical trial of episodic migraine that included subjects both naïve to, and those who had failed, previous preventives. Here we evaluated the efficacy and safety of erenumab (70 mg or 140 mg) versus placebo in the subgroup of patients who had previously failed preventive treatment(s): ≥1 or ≥2 prior failed migraine preventive categories, and in patients who had never failed.
METHODS


Prespecified subgroup analyses evaluated change from baseline to months 4-6 (the primary endpoint of the blinded study phase) in monthly migraine days, achievement of ≥50% and ≥75% reduction in monthly migraine days, and change from baseline in acute migraine-specific medication days. Adverse events were also evaluated.
RESULTS


Treatment with both doses of erenumab resulted in greater reductions in monthly migraine days at months 4-6 (treatment difference versus placebo [95% CI], never failed subgroup: -0.9 [-1.5, -0.3] for 70 mg and -1.3 [-1.9, -0.7] for 140 mg; ≥1 prior failed medication categories subgroup: -2.0 [-2.8, -1.2] for 70 mg and -2.5 [-3.4, -1.7] for 140 mg; ≥2 prior failed medication categories subgroup: -1.3 [-2.6, 0.0] for 70 mg and -2.7 [-4.0, -1.4] for 140 mg). Similar results were observed in the monthly acute migraine-specific medication days endpoint, and in the achievement of ≥50% and ≥75% reduction in monthly migraine days. For the ≥50% reduction in monthly migraine day endpoint, placebo response in the no prior treatment failed group was 32.6%, in the ≥1 failed treatment 17.5%, and in the ≥2 failed treatments 11.1%.
CONCLUSION


Erenumab showed consistent efficacy in episodic migraine patients who had failed prior preventive treatments and was well tolerated across subgroups. The data suggest prior patients with prior treatment failures have lower placebo response rates.",2019,"RESULTS


Treatment with both doses of erenumab resulted in greater reductions in monthly migraine days at months 4-6 (treatment difference versus placebo [95% CI], never failed subgroup: -0.9 [-1.5, -0.3] for 70 mg and -1.3 [-1.9, -0.7] for 140 mg; ≥1 prior failed medication categories subgroup: -2.0 [-2.8, -1.2] for 70 mg and -2.5 [-3.4, -1.7] for 140 mg; ≥2 prior failed medication categories subgroup: -1.3 [-2.6, 0.0] for 70 mg and -2.7 [-4.0, -1.4] for 140 mg).","['episodic migraine patients', 'subgroup of patients who had previously failed preventive treatment(s): ≥1 or ≥2 prior failed migraine preventive categories, and in patients who had never failed', 'episodic migraine patients with prior preventive treatment failure']","['erenumab', 'erenumab (AMG334', 'placebo']","['Adverse events', 'monthly migraine days', 'Efficacy and safety', 'efficacy and safety', 'placebo response']","[{'cui': 'C1455761', 'cui_str': 'Episodic (qualifier value)'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C1456501', 'cui_str': 'Preventive'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}]","[{'cui': 'C4542165', 'cui_str': 'erenumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]",,0.06126,"RESULTS


Treatment with both doses of erenumab resulted in greater reductions in monthly migraine days at months 4-6 (treatment difference versus placebo [95% CI], never failed subgroup: -0.9 [-1.5, -0.3] for 70 mg and -1.3 [-1.9, -0.7] for 140 mg; ≥1 prior failed medication categories subgroup: -2.0 [-2.8, -1.2] for 70 mg and -2.5 [-3.4, -1.7] for 140 mg; ≥2 prior failed medication categories subgroup: -1.3 [-2.6, 0.0] for 70 mg and -2.7 [-4.0, -1.4] for 140 mg).","[{'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Goadsby', 'Affiliation': ""1 NIHR-Wellcome Trust King's Clinical Research Facility, King's College London, UK.""}, {'ForeName': 'Koen', 'Initials': 'K', 'LastName': 'Paemeleire', 'Affiliation': '3 Department of Neurology, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Gregor', 'Initials': 'G', 'LastName': 'Broessner', 'Affiliation': '4 Department of Neurology, Headache Outpatient Clinic, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Brandes', 'Affiliation': '5 Nashville Neuroscience Group and Vanderbilt University School of Neurology, Nashville, TN, USA.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Klatt', 'Affiliation': '6 Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': '7 Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Hernan', 'Initials': 'H', 'LastName': 'Picard', 'Affiliation': '7 Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Lenz', 'Affiliation': '7 Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Daniel D', 'Initials': 'DD', 'LastName': 'Mikol', 'Affiliation': '7 Amgen Inc., Thousand Oaks, CA, USA.'}]",Cephalalgia : an international journal of headache,['10.1177/0333102419835459']
193,32297945,Effect of Treatment Expectation on Placebo Response and Analgesic Efficacy: A Secondary Aim in a Randomized Clinical Trial.,,2020,,[],[],['Placebo Response and Analgesic Efficacy'],[],[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.420829,,"[{'ForeName': 'Anne E', 'Initials': 'AE', 'LastName': 'Sanders', 'Affiliation': 'Division of Pediatric and Public Health, Adams School of Dentistry, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Gary D', 'Initials': 'GD', 'LastName': 'Slade', 'Affiliation': 'Division of Pediatric and Public Health, Adams School of Dentistry, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Roger B', 'Initials': 'RB', 'LastName': 'Fillingim', 'Affiliation': 'Department of Community Dentistry and Behavioral Science, University of Florida, Gainesville.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Ohrbach', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, University at Buffalo, State University of New York, Buffalo.'}, {'ForeName': 'Samuel J', 'Initials': 'SJ', 'LastName': 'Arbes', 'Affiliation': 'Rho Inc, Durham, North Carolina.'}, {'ForeName': 'Inna E', 'Initials': 'IE', 'LastName': 'Tchivileva', 'Affiliation': 'Division of Oral and Craniofacial Health Sciences, Adams School of Dentistry, University of North Carolina at Chapel Hill.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.2907']
194,32297946,Effect of Smartphone-Enabled Health Monitoring Devices vs Regular Follow-up on Blood Pressure Control Among Patients After Myocardial Infarction: A Randomized Clinical Trial.,"Importance


Smart technology via smartphone-compatible devices might improve blood pressure (BP) regulation in patients after myocardial infarction.
Objectives


To investigate whether smart technology in clinical practice can improve BP regulation and to evaluate the feasibility of such an intervention.
Design, Setting, and Participants


This study was an investigator-initiated, single-center, nonblinded, feasibility, randomized clinical trial conducted at the Department of Cardiology of the Leiden University Medical Center between May 2016 and December 2018. Two hundred patients, who were admitted with either ST-segment elevation myocardial infarction or non-ST-segment acute coronary syndrome, were randomized in a 1:1 fashion between follow-up groups using smart technology and regular care. Statistical analysis was performed from January 2019 to March 2019.
Interventions


For patients randomized to regular care, 4 physical outpatient clinic visits were scheduled in the year following the initial event. In the intervention group, patients were given 4 smartphone-compatible devices (weight scale, BP monitor, rhythm monitor, and step counter). In addition, 2 in-person outpatient clinic visits were replaced by electronic visits.
Main Outcomes and Measures


The primary outcome was BP control. Secondary outcomes, as a parameter of feasibility, included patient satisfaction (general questionnaire and smart technology-specific questionnaire), measurement adherence, all-cause mortality, and hospitalizations for nonfatal adverse cardiac events.
Results


In total, 200 patients (median age, 59.7 years [interquartile range, 52.9-65.6 years]; 156 men [78%]) were included, of whom 100 were randomized to the intervention group and 100 to the control group. After 1 year, 79% of patients in the intervention group had controlled BP vs 76% of patients in the control group (P = .64). General satisfaction with care was the same between groups (mean [SD] scores, 82.6 [14.1] vs 82.0 [15.1]; P = .88). The all-cause mortality rate was 2% in both groups (P > .99). A total of 20 hospitalizations for nonfatal adverse cardiac events occurred (8 in the intervention group and 12 in the control group). Of all patients, 32% sent in measurements each week, with 63% sending data for more than 80% of the weeks they participated in the trial. In the intervention group only, 90.3% of patients were satisfied with the smart technology intervention.
Conclusions and Relevance


These findings suggest that smart technology yields similar percentages of patients with regulated BP compared with the standard of care. Such an intervention is feasible in clinical practice and is accepted by patients. More research is mandatory to improve patient selection of such an intervention.
Trial Registration


ClinicalTrials.gov Identifier: NCT02976376.",2020,"After 1 year, 79% of patients in the intervention group had controlled BP vs 76% of patients in the control group (P = .64).","['Patients', '200 patients (median age, 59.7 years [interquartile range, 52.9-65.6 years]; 156 men [78', 'patients after myocardial infarction', 'Two hundred patients, who were admitted with either ST-segment elevation myocardial infarction or non-ST-segment acute coronary syndrome', 'After Myocardial Infarction', 'Department of Cardiology of the Leiden University Medical Center between May 2016 and December 2018']","['Smartphone-Enabled Health Monitoring Devices vs Regular Follow-up', 'smart technology and regular care']","['BP regulation', 'blood pressure (BP) regulation', 'controlled BP', 'BP control', 'mortality rate', 'nonfatal adverse cardiac events', 'General satisfaction with care', 'parameter of feasibility, included patient satisfaction (general questionnaire and smart technology-specific questionnaire), measurement adherence, all-cause mortality, and hospitalizations for nonfatal adverse cardiac events', 'Blood Pressure Control']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}, {'cui': 'C0429029', 'cui_str': 'ST segment'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0562342', 'cui_str': 'Empowered'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0235048', 'cui_str': 'Smarting pain'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0235048', 'cui_str': 'Smarting pain'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",200.0,0.0937239,"After 1 year, 79% of patients in the intervention group had controlled BP vs 76% of patients in the control group (P = .64).","[{'ForeName': 'Roderick W', 'Initials': 'RW', 'LastName': 'Treskes', 'Affiliation': 'Department of Cardiology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Loes A M', 'Initials': 'LAM', 'LastName': 'van Winden', 'Affiliation': 'Department of Cardiology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'van Keulen', 'Affiliation': 'Department of Cardiology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Enno T', 'Initials': 'ET', 'LastName': 'van der Velde', 'Affiliation': 'Department of Cardiology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Saskia L M A', 'Initials': 'SLMA', 'LastName': 'Beeres', 'Affiliation': 'Department of Cardiology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Douwe E', 'Initials': 'DE', 'LastName': 'Atsma', 'Affiliation': 'Department of Cardiology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Martin Jan', 'Initials': 'MJ', 'LastName': 'Schalij', 'Affiliation': 'Department of Cardiology, Leiden University Medical Center, Leiden, the Netherlands.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.2165']
195,32122898,Intravenous and Intraperitoneal Pharmacokinetics of Dalbavancin in Peritoneal Dialysis Patients.,"Dalbavancin offers a possible treatment option for infectious peritonitis associated with peritoneal dialysis (PD) due to its coverage of Gram-positive bacteria and pharmacokinetic properties. We aimed to evaluate the clinical pharmacokinetics (PK) and pharmacodynamics of dalbavancin in a prospective, randomized, open-label, crossover PK study of adult patients with end-stage renal disease ESRD who were receiving PD. Sampling occurred prior to a single 30-min infusion of dalbavancin at 1,500 mg and at 1, 2, 3, 4, and 6 h and 7 and 14 days postadministration. Concentration-time data were analyzed via noncompartmental analysis. Pharmacodynamic parameters against common infectious peritonitis-causing pathogens were evaluated. Ten patients were enrolled. Patients were a median of 55 years old and had a median weight of 78.2 kg, 50% were female, and 70% were Caucasian. The terminal plasma half-life of dalbavancin was 181.4 ± 35.5 h. The day 0 to day 14 dalbavancin mean area under the curve (AUC) was 40,573.2 ± 9,800.3 mg·h/liter. The terminal-phase half-life of dalbavancin within the peritoneal fluid was 4.309 × 10 8  ± 1.140 × 10 9  h. The day 0 to day 14 dalbavancin mean peritoneal fluid AUC was 2,125.0 ± 1,794.3 mg·h/liter. The target plasma AUC/MIC was attained with the intravenous dose in all 10 patients for all  Staphylococcus  and  Streptococcus  species at the recommended MIC breakpoints. The intraperitoneal arm of the study was stopped early, because the first 3 patients experienced moderate to severe pain and bloating within 1 h following the administration of dalbavancin. Dalbavancin at 1,500 mg administered intravenously can be utilized without dose adjustment in peritoneal dialysis patients and will likely achieve the necessary peritoneal fluid concentrations to treat peritonitis caused by typical Gram-positive pathogens.",2020,AUC/MIC was attained with the intravenous dose in all 10 patients for all Staphylococcus and Streptococcus species at recommended MIC breakpoints.,"['Ten patients were enrolled', 'Patients were a median of 55 years old, 78.2 kg, 50% female, and 70% Caucasian', 'patients receiving PD', 'adult patients with ESRD who were receiving PD', 'peritoneal dialysis patients']","['dalbavancin', 'Dalbavancin']","['L. Target plasma', 'clinical pharmacokinetics (PK) and pharmacodynamics', 'Concentration-time data', 'AUC/MIC', 'severe pain and bloating']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1292718', 'cui_str': 'Is a'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0022661', 'cui_str': 'End-Stage Kidney Disease'}, {'cui': 'C0031139', 'cui_str': 'Peritoneal Dialysis'}]","[{'cui': 'C1172636', 'cui_str': 'dalbavancin'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0427978', 'cui_str': 'Minimum Inhibitory Concentration'}, {'cui': 'C0278140', 'cui_str': 'Severe pain (finding)'}]",10.0,0.0301617,AUC/MIC was attained with the intravenous dose in all 10 patients for all Staphylococcus and Streptococcus species at recommended MIC breakpoints.,"[{'ForeName': 'E T', 'Initials': 'ET', 'LastName': 'Van Matre', 'Affiliation': 'Department of Clinical Pharmacy and Translational Science, University of Tennessee Health Science Center College of Pharmacy, Memphis, Tennessee, USA.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Teitelbaum', 'Affiliation': 'Department of Medicine, University of Colorado School of Medicine, Aurora, Colorado, USA.'}, {'ForeName': 'T H', 'Initials': 'TH', 'LastName': 'Kiser', 'Affiliation': 'Department of Clinical Pharmacy, University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences, Aurora, Colorado, USA Ty.Kiser@ucdenver.edu.'}]",Antimicrobial agents and chemotherapy,['10.1128/AAC.02089-19']
196,32315057,Effect of Intravenous Zoledronic Acid on Tibiofemoral Cartilage Volume Among Patients With Knee Osteoarthritis With Bone Marrow Lesions: A Randomized Clinical Trial.,"Importance


A proof-of-principle study suggested that intravenous zoledronic acid may reduce knee pain and the size of bone marrow lesions in people with knee osteoarthritis, but data from large trials are lacking.
Objective


To determine the effects of intravenous zoledronic acid on knee cartilage volume loss in patients with symptomatic knee osteoarthritis and bone marrow lesions.
Design, Setting, and Participants


A 24-month multicenter, double-blind placebo-controlled randomized clinical trial conducted at 4 sites in Australia (1 research center and 3 hospitals). Adults aged 50 years or older with symptomatic knee osteoarthritis and subchondral bone marrow lesions detected by magnetic resonance imaging (MRI) were enrolled from November 2013 through September 2015. The final date of follow-up was October 9, 2017.
Interventions


Intravenous infusion with either 5 mg of zoledronic acid in a 100-mL saline solution (n = 113) or a placebo saline solution (n = 110) at baseline and 12 months.
Main Outcomes and Measures


The primary outcome was absolute change in tibiofemoral cartilage volume assessed using MRI over 24 months (the minimum clinically important difference [MCID] has not been established). Three prespecified secondary outcomes were change in knee pain assessed by a visual analog scale (0 [no pain] to 100 [unbearable pain]; MCID, 15) and the Western Ontario and McMaster Universities Osteoarthritis Index (0 [no pain] to 500 [unbearable pain]; MCID, 75) over 3, 6, 12, 18, and 24 months and change in bone marrow lesion size over 6 and 24 months (the MCID has not been established).
Results


Of 223 participants enrolled (mean age, 62.0 years [SD, 8.0 years]; 52% were female), 190 (85%) completed the trial. Change in tibiofemoral cartilage volume was not significantly different between the zoledronic acid group and the placebo group over 24 months (-878 mm3 vs -919 mm3; between-group difference, 41 mm3 [95% CI, -79 to 161 mm3]; P = .50). No significant between-group differences were found for any of the prespecified secondary outcomes, including changes in knee pain assessed by a visual analog scale (-11.5 in the zoledronic acid group vs -16.8 in the placebo group; between-group difference, 5.2 [95% CI, -2.3 to 12.8]; P = .17), changes in knee pain assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (-37.5 vs -58.0, respectively; between-group difference, 20.5 [95% CI, -11.2 to 52.2]; P = .21), and changes in bone marrow lesion size (-33 mm2 vs -6 mm2; between-group difference, -27 mm2 [95% CI, -127 to 73 mm2]; P = .60) over 24 months. Adverse events were more common with zoledronic acid than with placebo (96% vs 83%, respectively) and consisted mainly of acute reactions (defined as symptoms within 3 days of administration of infusion; 87% vs 56%).
Conclusions and Relevance


Among patients with symptomatic knee osteoarthritis and bone marrow lesions, yearly zoledronic acid infusions, compared with placebo, did not significantly reduce cartilage volume loss over 24 months. These findings do not support the use of zoledronic acid in the treatment of knee osteoarthritis.
Trial Registration


anzctr.org.au Identifier: ACTRN12613000039785.",2020,"Change in tibiofemoral cartilage volume was not significantly different between the zoledronic acid group and the placebo group over 24 months (-878 mm3 vs -919 mm3; between-group difference, 41 mm3 [95% CI, -79 to 161 mm3]; P = .50).","['4 sites in Australia (1 research center and 3 hospitals', 'people with knee osteoarthritis', 'Adults aged 50 years or older with symptomatic knee osteoarthritis and subchondral bone marrow lesions detected by magnetic resonance imaging (MRI) were enrolled from November 2013 through September 2015', ' 52% were female), 190 (85%) completed the trial', 'Patients With Knee Osteoarthritis With Bone Marrow Lesions', '223 participants enrolled (mean age, 62.0 years [SD, 8.0 years', 'patients with symptomatic knee osteoarthritis and bone marrow lesions']","['Intravenous Zoledronic Acid', 'placebo', 'zoledronic acid infusions', 'zoledronic acid', 'placebo saline solution']","['Adverse events', 'absolute change in tibiofemoral cartilage volume', 'Change in tibiofemoral cartilage volume', 'changes in knee pain assessed by a visual analog scale', 'change in knee pain assessed by a visual analog scale (0 [no pain] to 100 [unbearable pain]; MCID, 15) and the Western Ontario and McMaster Universities Osteoarthritis Index (0', 'knee cartilage volume loss', 'no pain', 'bone marrow lesion size', 'cartilage volume loss', 'Tibiofemoral Cartilage Volume', 'acute reactions', 'knee pain assessed by the Western Ontario and McMaster Universities Osteoarthritis Index']","[{'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517622', 'cui_str': '190'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0257685', 'cui_str': 'zoledronic acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0007301', 'cui_str': 'Cartilage tissue'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0234225', 'cui_str': 'No pain'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C0449453', 'cui_str': 'Lesion size'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}]",223.0,0.637902,"Change in tibiofemoral cartilage volume was not significantly different between the zoledronic acid group and the placebo group over 24 months (-878 mm3 vs -919 mm3; between-group difference, 41 mm3 [95% CI, -79 to 161 mm3]; P = .50).","[{'ForeName': 'Guoqi', 'Initials': 'G', 'LastName': 'Cai', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Hobart, Australia.'}, {'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Aitken', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Hobart, Australia.'}, {'ForeName': 'Laura L', 'Initials': 'LL', 'LastName': 'Laslett', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Hobart, Australia.'}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Pelletier', 'Affiliation': 'Osteoarthritis Research Unit, University of Montreal Hospital Research Centre, Notre-Dame Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Johanne', 'Initials': 'J', 'LastName': 'Martel-Pelletier', 'Affiliation': 'Osteoarthritis Research Unit, University of Montreal Hospital Research Centre, Notre-Dame Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Hill', 'Affiliation': 'Queen Elizabeth Hospital, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Lyn', 'Initials': 'L', 'LastName': 'March', 'Affiliation': 'University of Sydney, Royal North Shore Hospital, Sydney, Australia.'}, {'ForeName': 'Anita E', 'Initials': 'AE', 'LastName': 'Wluka', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, Alfred Hospital, Melbourne, Australia.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, Alfred Hospital, Melbourne, Australia.'}, {'ForeName': 'Benny', 'Initials': 'B', 'LastName': 'Antony', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Hobart, Australia.'}, {'ForeName': 'Leigh', 'Initials': 'L', 'LastName': 'Blizzard', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Hobart, Australia.'}, {'ForeName': 'Tania', 'Initials': 'T', 'LastName': 'Winzenberg', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Hobart, Australia.'}, {'ForeName': 'Flavia', 'Initials': 'F', 'LastName': 'Cicuttini', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, Alfred Hospital, Melbourne, Australia.'}, {'ForeName': 'Graeme', 'Initials': 'G', 'LastName': 'Jones', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Hobart, Australia.'}]",JAMA,['10.1001/jama.2020.2938']
197,32316824,Sexual Activity and Substance Use Among Adolescents and Young Adults Receiving Cancer Treatment: A Report from the PRISM Randomized Controlled Trial.,"Purpose:  Despite health implications, sexual activity and substance use among adolescents and young adults (AYAs) receiving cancer treatment are understudied.  Methods:  AYAs 12-25 years of age participated in a randomized controlled trial testing the efficacy of a resilience intervention. They were fluent in English and either diagnosed with new cancer (NC) or advanced cancer (AC). At baseline and 6 months, participants self-reported sexual activity and substance use. We describe the percentage of AYAs who endorsed each behavior and a count of total behaviors endorsed by each respondent. We describe frequencies by sex/gender (male/female), age (<18/≥18), and disease status (AC/NC).  Results:  Participants ( N  = 92) were majority white/Caucasian (57%), 12-17 years old (73%), and diagnosed with leukemia/lymphoma (62%); 32% had AC. Responses were not associated with the intervention; hence, we summarized data from the whole cohort. At both time points, median behavior endorsed was 2. At baseline and follow-up, 87% and 81% endorsed at least 1 behavior: 13% and 15% were sexually active, 75% and 73% of whom used birth control inconsistently; and 22% and 22% reported drinking alcohol, 31% and 27% using prescription opioids/sedatives, 19% and 22% using other drugs, and 9% and 7% using tobacco. Young adults engaged in most behaviors more frequently than adolescents (e.g., 48% vs. 12% alcohol at baseline); males engaged in sexual activity more frequently than females (e.g., 20% vs. 5% sexually active at baseline); and AYAs with NC engaged in most behaviors more frequently than those with AC (18% vs. 0% sexually active at baseline).  Conclusion:  AYAs engage in sexual activity and substance use during cancer treatment.",2020,"Young adults engaged in most behaviors more frequently than adolescents (e.g., 48% vs. 12% alcohol at baseline); males engaged in sexual activity more frequently than females (e.g., 20% vs. 5% sexually active at baseline); and AYAs with NC engaged in most behaviors more frequently than those with AC (18% vs. 0% sexually active at baseline).  ","['Receiving Cancer Treatment', 'adolescents and young adults (AYAs) receiving cancer treatment are understudied', 'Adolescents and Young Adults', 'They were fluent in English and either diagnosed with new cancer (NC) or advanced cancer (AC', '12-25 years of age participated', 'Results:  Participants ( N \u2009=\u200992) were majority white/Caucasian (57%), 12-17 years old (73%), and diagnosed with leukemia/lymphoma (62%); 32% had AC', 'sex/gender (male/female), age (<18/≥18), and disease status (AC/NC']",['resilience intervention'],"['Sexual Activity and Substance Use', 'drinking alcohol', 'sexual activity', 'sexual activity and substance use']","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0043157', 'cui_str': 'Caucasian'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0023418', 'cui_str': 'Leukemia'}, {'cui': 'C0024299', 'cui_str': 'Malignant lymphoma'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449438', 'cui_str': 'Status'}]","[{'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}]",92.0,0.0804546,"Young adults engaged in most behaviors more frequently than adolescents (e.g., 48% vs. 12% alcohol at baseline); males engaged in sexual activity more frequently than females (e.g., 20% vs. 5% sexually active at baseline); and AYAs with NC engaged in most behaviors more frequently than those with AC (18% vs. 0% sexually active at baseline).  ","[{'ForeName': 'Kaitlyn M', 'Initials': 'KM', 'LastName': 'Fladeboe', 'Affiliation': ""Center for Clinical and Translational Research, Seattle Children's Research Institute, Seattle, Washington, USA.""}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Scott', 'Affiliation': ""Center for Clinical and Translational Research, Seattle Children's Research Institute, Seattle, Washington, USA.""}, {'ForeName': 'Miranda C', 'Initials': 'MC', 'LastName': 'Bradford', 'Affiliation': ""Center for Clinical and Translational Research, Seattle Children's Research Institute, Seattle, Washington, USA.""}, {'ForeName': 'Tyler G', 'Initials': 'TG', 'LastName': 'Ketterl', 'Affiliation': 'Department of Pediatrics, University of Washington School of Medicine, Seattle, Washington, USA.'}, {'ForeName': 'Joyce P', 'Initials': 'JP', 'LastName': 'Yi-Frazier', 'Affiliation': ""Center for Clinical and Translational Research, Seattle Children's Research Institute, Seattle, Washington, USA.""}, {'ForeName': 'Abby R', 'Initials': 'AR', 'LastName': 'Rosenberg', 'Affiliation': ""Center for Clinical and Translational Research, Seattle Children's Research Institute, Seattle, Washington, USA.""}]",Journal of adolescent and young adult oncology,['10.1089/jayao.2020.0001']
198,31978225,High total metabolic tumor volume at baseline predicts survival independent of response to therapy.,"Early identification of ultra-risk diffuse large B-cell lymphoma (DLBCL) patients is needed to aid stratification to innovative treatment. Previous studies suggested high baseline total metabolic tumor volume (TMTV) negatively impacts survival of DLBCL patients. We analyzed the prognostic impact of TMTV and prognostic indices in DLBCL patients, aged 60 to 80 years, from the phase 3 REMARC study that randomized responding patients to R-CHOP (rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone) into maintenance lenalidomide or placebo. TMTV was computed on baseline positron emission tomography/computed tomography using the 41% maximum standardized uptake value method; the optimal TMTV cutoff for progression-free (PFS) and overall survival (OS) was determined and confirmed by a training validation method. There were 301 out of 650 evaluable patients, including 192 patients classified as germinal center B-cell-like (GCB)/non-GCB and MYC/BCL2 expressor. Median baseline TMTV was 238 cm3; optimal TMTV cutoff was 220 cm3. Patients with high vs low TMTV showed worse/higher Eastern Cooperative Oncology Group performance status (ECOG PS) ≥2, stage III or IV disease, >1 extranodal site, elevated lactate dehydrogenase, International Prognostic Index (IPI) 3-5, and age-adjusted IPI 2-3. High vs low TMTV significantly impacted PFS and OS, independent of maintenance treatment. Although the GCB/non-GCB profile and MYC expression did not correlate with TMTV/survival, BCL2 >70% impacted PFS and could be stratified by TMTV. Multivariate analysis identified baseline TMTV and ECOG PS as independently associated with PFS and OS. Even in responding patients, after R-CHOP, high baseline TMTV was a strong prognosticator of inferior PFS and OS. Moreover, TMTV combined with ECOG PS may identify an ultra-risk DLBCL population. This trial was registered at www.clinicaltrials.gov as #NCT01122472.",2020,"High vs low TMTV significantly impacted PFS (HR=2.3; P = .0002) and OS (HR=3.3; P = .0001), independent of maintenance treatment.","['301/650 evaluable patients (n=155 lenalidomide; n=146 placebo), including 192 patients classified as GCB/non-GCB and MYC/BCL2 expressor', 'DLBCL patients, aged 60 to 80 years, from the phase III REMARC study that randomized responding patients to RCHOP into maintenance lenalidomide or', 'patients aged 60 to 80 years responding to R-CHOP', 'ultra-risk diffuse large B-cell lymphoma (DLBCL) patients']","['TMTV', 'placebo', 'TMTV combined with ECOG PS']","['PFS', 'High total metabolic tumor volume', 'GCB/non-GCB profile and MYC expression', 'TMTV cut-off for progression-free (PFS) and overall survival (OS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0079744', 'cui_str': 'Diffuse Large-Cell Lymphoma'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0430797', 'cui_str': 'Intracranial EEG'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0475276', 'cui_str': 'Tumor Volume'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0000925', 'cui_str': 'Incised wound - morphology (morphologic abnormality)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.130353,"High vs low TMTV significantly impacted PFS (HR=2.3; P = .0002) and OS (HR=3.3; P = .0001), independent of maintenance treatment.","[{'ForeName': 'Laetitia', 'Initials': 'L', 'LastName': 'Vercellino', 'Affiliation': 'Assistance Publique-Hôpitaux de Paris, Hôpital Saint-Louis, Nuclear Medecine, Paris, France.'}, {'ForeName': 'Anne-Segolene', 'Initials': 'AS', 'LastName': 'Cottereau', 'Affiliation': 'Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Nuclear Medecine, René Descartes University, Paris, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Casasnovas', 'Affiliation': ""Service d'Hématologie Clinique, Centre Hospitalier Universitaire Dijon, INSERM UMR1231, Dijon, France.""}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Tilly', 'Affiliation': 'Department of Hematology, Centre Henri Becquerel, University Rouen, INSERM U1245, Rouen, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Feugier', 'Affiliation': 'Department of Hematology, Centre Hospitalier Universitaire Nancy, INSERM 1256, Nancy, France.'}, {'ForeName': 'Loic', 'Initials': 'L', 'LastName': 'Chartier', 'Affiliation': 'The Lymphoma Academic Research Organisation, Statistic, Centre Hospitalier Lyon Sud, Pierre-Benite, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Fruchart', 'Affiliation': ""Hématologie, Institut d'Hématologie de Basse Normandie, Centre Hospitalier Universitaire, Caen, France.""}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Roulin', 'Affiliation': 'University Hospital Henri-Mondor Assistance Publique-Hôpitaux de Paris, Creteil, France.'}, {'ForeName': 'Lucie', 'Initials': 'L', 'LastName': 'Oberic', 'Affiliation': 'Hôpital de Purpan, Centre Hospitalier Universitaire Toulouse, Toulouse, France.'}, {'ForeName': 'Gian Matteo', 'Initials': 'GM', 'LastName': 'Pica', 'Affiliation': 'Department of Hematology, Centre Hospitalier Métropole Savoie Chambéry, Chambéry, France.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Ribrag', 'Affiliation': 'Hematology, Institut Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Abraham', 'Affiliation': 'Centre Hospitalier Universitaire Dupuytren, Limoges, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Simon', 'Affiliation': 'Institut Jules Bordet, Brussels, Belgium.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Gonzalez', 'Affiliation': 'Centre Hospitalier René Dubos, Pontoise, France.'}, {'ForeName': 'Reda', 'Initials': 'R', 'LastName': 'Bouabdallah', 'Affiliation': 'Department of Hematology, Institut Paoli Calmettes, Marseille, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Fitoussi', 'Affiliation': 'Hematology/Oncology, Polyclinique Bordeaux Nord Aquitaine, Bordeaux, France.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Sebban', 'Affiliation': 'Hematologie, Centre Leon Berard, Lyon, France.'}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'López-Guillermo', 'Affiliation': 'Hematology, Hospital Clinic Barcelona, Barcelona, Spain.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Sanhes', 'Affiliation': 'Hematology, Centre Hospitalier Marechal Joffre-Hôpital Saint-Jean, Perpignan, France.'}, {'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Morschhauser', 'Affiliation': 'Hematology, Université Lille, Centre Hospitalier Universitaire Lille, EA 7365 Groupe de Recherche sur les formes Injectables et les Technologies Associées, Lille, France.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Trotman', 'Affiliation': 'Concord Repatriation General Hospital, University of Sydney, Concord NSW, Australia.'}, {'ForeName': 'Bernadette', 'Initials': 'B', 'LastName': 'Corront', 'Affiliation': ""Service d'Hématologie Clinique, Centre Hospitalier Regional Annecy, Annecy, France.""}, {'ForeName': 'Bachra', 'Initials': 'B', 'LastName': 'Choufi', 'Affiliation': 'Hematology, Centre Hospitalier Dr Duchenne, Boulogne-Sur-Mer, France.'}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Snauwaert', 'Affiliation': 'Hematology, Algemeen Ziekenhuis Sint-Jan, Brugge, Belgium.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Godmer', 'Affiliation': 'Hematology, Centre Hospitalier Bretagne Atlantique, Vannes, France.'}, {'ForeName': 'Josette', 'Initials': 'J', 'LastName': 'Briere', 'Affiliation': 'Pathology, INSERM U955, University Hospital Henri-Mondor, Assistance Publique-Hôpitaux de Paris, Créteil, France.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Salles', 'Affiliation': 'Department of Hematology, INSERM U1052 Hospices Civils de Lyon, University of Lyon, Pierre-Bénite, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Gaulard', 'Affiliation': 'Pathology, INSERM U955, University Hospital Henri-Mondor Assistance Publique-Hôpitaux de Paris, Créteil, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Meignan', 'Affiliation': 'Lymphoma Study Association-Imaging, Hospital Henri-Mondor, Assistance Publique-Hôpitaux de Paris, University Paris-Est Créteil, Créteil, France.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Thieblemont', 'Affiliation': 'Assistance Publique-Hôpitaux de Paris, Hôpital Saint-Louis, Hemato-Oncology, Paris, France; and.'}]",Blood,['10.1182/blood.2019003526']
199,32053828,Global connectivity and local excitability changes underlie antidepressant effects of repetitive transcranial magnetic stimulation.,"Repetitive transcranial magnetic stimulation (rTMS) is a commonly- used treatment for major depressive disorder (MDD). However, our understanding of the mechanism by which TMS exerts its antidepressant effect is minimal. Furthermore, we lack brain signals that can be used to predict and track clinical outcome. Such signals would allow for treatment stratification and optimization. Here, we performed a randomized, sham-controlled clinical trial and measured electrophysiological, neuroimaging, and clinical changes before and after rTMS. Patients (N = 36) were randomized to receive either active or sham rTMS to the left dorsolateral prefrontal cortex (dlPFC) for 20 consecutive weekdays. To capture the rTMS-driven changes in connectivity and causal excitability, resting fMRI and TMS/EEG were performed before and after the treatment. Baseline causal connectivity differences between depressed patients and healthy controls were also evaluated with concurrent TMS/fMRI. We found that active, but not sham rTMS elicited (1) an increase in dlPFC global connectivity, (2) induction of negative dlPFC-amygdala connectivity, and (3) local and distributed changes in TMS/EEG potentials. Global connectivity changes predicted clinical outcome, while both global connectivity and TMS/EEG changes tracked clinical outcome. In patients but not healthy participants, we observed a perturbed inhibitory effect of the dlPFC on the amygdala. Taken together, rTMS induced lasting connectivity and excitability changes from the site of stimulation, such that after active treatment, the dlPFC appeared better able to engage in top-down control of the amygdala. These measures of network functioning both predicted and tracked clinical outcome, potentially opening the door to treatment optimization.",2020,Patients (N = 36) were randomized to receive either active or sham rTMS to the left dorsolateral prefrontal cortex (dlPFC) for 20 consecutive weekdays.,"['Patients (N\u2009=\u200936', 'depressed patients and healthy controls', 'major depressive disorder (MDD']","['Repetitive transcranial magnetic stimulation (rTMS', 'active or sham rTMS to the left dorsolateral prefrontal cortex (dlPFC', 'TMS', 'repetitive transcranial magnetic stimulation', 'rTMS']","['connectivity and causal excitability, resting fMRI and TMS/EEG', 'global connectivity and TMS/EEG changes tracked clinical outcome', 'dlPFC global connectivity, (2) induction of negative dlPFC-amygdala connectivity, and (3) local and distributed changes in TMS/EEG potentials']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0450424', 'cui_str': 'To the left (qualifier value)'}, {'cui': 'C4019080', 'cui_str': 'Dorsolateral Prefrontal Cortex'}]","[{'cui': 'C0235169', 'cui_str': 'Excitability (finding)'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0013819', 'cui_str': 'EEG'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid Body'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",36.0,0.0327488,Patients (N = 36) were randomized to receive either active or sham rTMS to the left dorsolateral prefrontal cortex (dlPFC) for 20 consecutive weekdays.,"[{'ForeName': 'Neir', 'Initials': 'N', 'LastName': 'Eshel', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Corey J', 'Initials': 'CJ', 'LastName': 'Keller', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wu', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Jiang', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Mills-Finnerty', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Huemer', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Wright', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Fonzo', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Naho', 'Initials': 'N', 'LastName': 'Ichikawa', 'Affiliation': 'Department of Psychiatry and Neurosciences, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Carreon', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Melinda', 'Initials': 'M', 'LastName': 'Wong', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Yee', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Shpigel', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': ""Department of Neurology, Shenzhen People's Hospital, Shenzhen, China.""}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'McTeague', 'Affiliation': 'Department of Psychiatry, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Adi', 'Initials': 'A', 'LastName': 'Maron-Katz', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Etkin', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA. amitetkin@stanford.edu.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0633-z']
200,32213473,"Text Messaging as a Screening Tool for Depression and Related Conditions in Underserved, Predominantly Minority Safety Net Primary Care Patients: Validity Study.","BACKGROUND


SMS text messaging is an inexpensive, private, and scalable technology-mediated assessment mode that can alleviate many barriers faced by the safety net population to receive depression screening. Some existing studies suggest that technology-mediated assessment encourages self-disclosure of sensitive health information such as depressive symptoms while other studies show the opposite effect.
OBJECTIVE


This study aimed to evaluate the validity of using SMS text messaging to screen depression and related conditions, including anxiety and functional disability, in a low-income, culturally diverse safety net primary care population.
METHODS


This study used a randomized design with 4 study groups that permuted the order of SMS text messaging and the gold standard interview (INTW) assessment. The participants for this study were recruited from the participants of the prior Diabetes-Depression Care-management Adoption Trial (DCAT). Depression was screened by using the 2-item and 8-item Patient Health Questionnaire (PHQ-2 and PHQ-8, respectively). Anxiety was screened by using the 2-item Generalized Anxiety Disorder scale (GAD-2), and functional disability was assessed by using the Sheehan Disability Scale (SDS). Participants chose to take up the assessment in English or Spanish. Internal consistency and test-retest reliability were evaluated by using Cronbach alpha and intraclass correlation coefficient (ICC), respectively. Concordance was evaluated by using an ICC, a kappa statistic, an area under the receiver operating characteristic curve (AUROC), sensitivity, and specificity. A regression analysis was conducted to examine the association between the participant characteristics and the differences in the scores between the SMS text messaging and INTW assessment modes.
RESULTS


Overall, 206 participants (average age 57.1 [SD 9.18] years; females: 119/206, 57.8%) were enrolled. All measurements except the SMS text messaging-assessed PHQ-2 showed Cronbach alpha values ≥.70, indicating acceptable to good internal consistency. All measurements except the INTW-assessed SDS had ICC values ≥0.75, indicating good to excellent test-retest reliability. For concordance, the PHQ-8 had an ICC of 0.73 and AUROC of 0.93, indicating good concordance. The kappa statistic, sensitivity, and specificity for major depression (PHQ-8 ≥8) were 0.43, 0.60, and 0.86, respectively. The concordance of the shorter PHQ-2, GAD-2, and SDS scales was poor to fair. The regression analysis revealed that a higher level of personal depression stigma was associated with reporting higher SMS text messaging-assessed PHQ-8 and GAD-2 scores than the INTW-assessed scores. The analysis also determined that the differences in the scores were associated with marital status and personality traits.
CONCLUSIONS


Depression screening conducted using the longer PHQ-8 scale via SMS text messaging demonstrated good internal consistency, test-retest reliability, and concordance with the gold standard INTW assessment mode. However, care must be taken when deploying shorter scales via SMS text messaging. Further regression analysis supported that a technology-mediated assessment, such as SMS text messaging, may create a private space with less pressure from the personal depression stigma and therefore encourage self-disclosure of depressive symptoms.
TRIAL REGISTRATION


ClinicalTrials.gov NCT01781013; https://clinicaltrials.gov/ct2/show/NCT01781013.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


RR2-10.2196/12392.",2020,"The kappa statistic, sensitivity, and specificity for major depression (PHQ-8 ≥8) were 0.43, 0.60, and 0.86, respectively.","['participants for this study were recruited from the participants of the prior Diabetes-Depression Care-management Adoption Trial (DCAT', '206 participants (average age 57.1 [SD 9.18] years; females: 119/206, 57.8%) were enrolled']","['SMS text messaging and the gold standard interview (INTW) assessment', 'SMS text messaging']","['personal depression stigma', 'Sheehan Disability Scale (SDS', 'Anxiety', 'Depression', '2-item Generalized Anxiety Disorder scale (GAD-2), and functional disability', 'kappa statistic, sensitivity, and specificity for major depression (PHQ-8 ≥8', 'PHQ-8 and GAD-2 scores', 'Internal consistency and test-retest reliability', 'shorter PHQ-2, GAD-2, and SDS scales']","[{'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4708576', 'cui_str': 'Depression care management'}, {'cui': 'C0001593', 'cui_str': 'Adoption'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0277787', 'cui_str': 'Stigma (finding)'}, {'cui': 'C4720840', 'cui_str': 'Sheehan disability scale'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}, {'cui': 'C0222045'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0439099', 'cui_str': 'Kappa'}, {'cui': 'C0600673', 'cui_str': 'Statistics'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C0332529', 'cui_str': 'Consistency finding'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0543431', 'cui_str': 'ret (qualifier value)'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}]",206.0,0.0829912,"The kappa statistic, sensitivity, and specificity for major depression (PHQ-8 ≥8) were 0.43, 0.60, and 0.86, respectively.","[{'ForeName': 'Haomiao', 'Initials': 'H', 'LastName': 'Jin', 'Affiliation': 'Suzanne Dworak-Peck School of Social Work, University of Southern California, Los Angeles, CA, United States.'}, {'ForeName': 'Shinyi', 'Initials': 'S', 'LastName': 'Wu', 'Affiliation': 'Suzanne Dworak-Peck School of Social Work, University of Southern California, Los Angeles, CA, United States.'}]",Journal of medical Internet research,['10.2196/17282']
201,32040038,Bundling Rapid Human Immunodeficiency Virus and Hepatitis C Virus Testing to Increase Receipt of Test Results: A Randomized Trial.,"BACKGROUND


The overlapping human immunodeficiency virus (HIV) and hepatitis C virus (HCV) epidemics disproportionately affect people with substance use disorders. However, many people who use substances remain unaware of their infection(s).
OBJECTIVE


The objective of this study was to examine the efficacy of an on-site bundled rapid HIV and HCV testing strategy in increasing receipt of both HIV and HCV test results.
RESEARCH DESIGN


Two-armed randomized controlled trial in substance use disorder treatment programs (SUDTP) in New York City. Participants in the treatment arm were offered bundled rapid HIV and HCV tests with immediate results on-site. Participants in the control arm were offered the standard of care, that is, referrals to on-site or off-site laboratory-based HIV and HCV testing with delayed results.
PARTICIPANTS


A total of 162 clients with unknown or negative HIV and HCV status.
MEASURES


The primary outcome was the percentage of participants with self-reported receipt of HIV and HCV test results at 1-month postrandomization.
RESULTS


Over half of participants were Hispanic (51.2%), with 25.3% being non-Hispanic black and 17.9% non-Hispanic white. Two thirds were male, and 54.9% reported injection as method of drug use. One hundred thirty-four participants (82.7%) completed the 1-month assessment. Participants in the treatment arm were more likely to report having received both test results than those in the control arm (69% vs. 19%, P<0.001). Seven participants in the treatment arm received a preliminary new HCV diagnosis, versus 1 in the control arm (P=0.029).
CONCLUSION


Offering bundled rapid HIV and HCV testing with immediate results on-site in SUDTPs may increase awareness of HIV and HCV infection among people with substance use disorders.",2020,"Seven participants in the treatment arm received a preliminary new HCV diagnosis, versus 1 in the control arm (P=0.029).
","['people with substance use disorders', 'A total of 162 clients with unknown or negative HIV and HCV status', 'One hundred thirty-four participants (82.7%) completed the 1-month assessment']",[],"['HIV and HCV infection', 'percentage of participants with self-reported receipt of HIV and HCV test results']","[{'cui': 'C0038586', 'cui_str': 'Substance Use Disorders'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0439673', 'cui_str': 'Unknown (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",[],"[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",162.0,0.0980228,"Seven participants in the treatment arm received a preliminary new HCV diagnosis, versus 1 in the control arm (P=0.029).
","[{'ForeName': 'Jemima A', 'Initials': 'JA', 'LastName': 'Frimpong', 'Affiliation': 'The Johns Hopkins Carey Business School, Baltimore, MD.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Shiu-Yee', 'Affiliation': 'Columbia University Mailman School of Public Health.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Tross', 'Affiliation': 'HIV Center for Clinical and Behavioral Studies Division of Gender, Sexuality, and Health New York State Psychiatric Institute and Columbia University.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': ""D'Aunno"", 'Affiliation': 'NYU Wagner Graduate School of Public Service.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Perlman', 'Affiliation': 'Icahn School of Medicine at Mount Sinai.'}, {'ForeName': 'Shiela M', 'Initials': 'SM', 'LastName': 'Strauss', 'Affiliation': 'NYU Rory Meyers College of Nursing.'}, {'ForeName': 'Bruce R', 'Initials': 'BR', 'LastName': 'Schackman', 'Affiliation': 'Weill Cornell Medical College, New York, NY.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Feaster', 'Affiliation': 'University of Miami Miller School of Medicine, Miami, FL.'}, {'ForeName': 'Lisa R', 'Initials': 'LR', 'LastName': 'Metsch', 'Affiliation': 'Columbia University Mailman School of Public Health.'}]",Medical care,['10.1097/MLR.0000000000001311']
202,32311073,A Caretaker Acute Stress Paradigm: Effects on behavior and physiology of caretaker and infant.,"While experimental stress paradigms of infants (arm restraint; the Still-Face) are powerful tools for infant research, no study has experimentally stressed mothers to observe its independent effects on infant stress regulation. Extant caretaker/maternal stress studies essentially are correlational and confounded by other conditions (e.g., depression). Here, we present a standard procedure, the Caregiver Acute Stress Paradigm (CASP), for stressing mothers during en face interactions with their infants. We hypothesized that infants of the stressed mothers would be more distressed than infants of non-stressed mothers. A total of 106 four-month-old infants and their mothers were randomly assigned to the experimental stress or non-stress manipulation. Confirming our hypothesis, infants of the stressed mothers were significantly more likely to become distressed and require terminating the procedure. While objective ratings of maternal behavior showed no difference between groups, mother in the stress condition self-rated the episode following the caretaker stress significantly lower than mothers in the non-stress group. The self-ratings in the maternal stress-group were reflected in infant cortisol. The findings indicate that CASP is an effective experimental paradigm for exploring the independent effects of an acute stress on caretakers, including effects of conditions, such as poverty or mental illness.",2020,"Confirming our hypothesis, infants of the stressed mothers were significantly more likely to become distressed and require terminating the procedure.","['A Caretaker Acute Stress Paradigm', 'stressing mothers during en face interactions with their infants', 'A total of 106 four-month-old infants and their mothers']","['Caregiver Acute Stress Paradigm (CASP', 'experimental stress or non-stress manipulation', 'CASP']",['behavior and physiology of caretaker and infant'],"[{'cui': 'C0335350', 'cui_str': 'Building caretaker'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0031842', 'cui_str': 'Physiology'}, {'cui': 'C0335350', 'cui_str': 'Building caretaker'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]",,0.0200918,"Confirming our hypothesis, infants of the stressed mothers were significantly more likely to become distressed and require terminating the procedure.","[{'ForeName': 'Ed', 'Initials': 'E', 'LastName': 'Tronick', 'Affiliation': 'Department of Psychology, University of Massachusetts Boston, Boston, MA, USA.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Mueller', 'Affiliation': 'Department of Psychology, University of Massachusetts Boston, Boston, MA, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'DiCorcia', 'Affiliation': 'Department of Psychology, University of Massachusetts Boston, Boston, MA, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Hunter', 'Affiliation': 'Department of Psychology, University of Massachusetts Boston, Boston, MA, USA.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Snidman', 'Affiliation': 'Department of Psychology, University of Massachusetts Boston, Boston, MA, USA.'}]",Developmental psychobiology,['10.1002/dev.21974']
203,32311110,Exposure-response relationships of dapagliflozin on cardiorenal risk markers and adverse events: A pooled analysis of 13 phase II/III trials.,"AIMS


Dapagliflozin is a sodium-glucose co-transporter 2 inhibitor that has been developed as oral glucose lowering drug. The original dosefinding studies focused on optimal glycaemic effects. However, dapagliflozin also affects various cardiorenal risk markers and provides cardiorenal protection. To evaluate whether the currently registered doses of 5 and 10 mg are optimal for cardiorenal efficacy and safety, we characterized the relationship between dapagliflozin exposure and nonglycaemic cardiorenal risk markers as well as adverse events.
METHODS


Data were obtained from a pooled database of 13 24-week randomized controlled clinical trials of the clinical development programme of dapagliflozin. The exposure-response relationship was quantified using population pharmacodynamic and repeated time-to-event models.
RESULTS


A dose of 10 mg dapagliflozin resulted in an average individual exposure of 638 ng h/mL (95% prediction interval [PI]: 354-1061 ng h/mL), which translated to 71.2% (95% PI: 57.9-80.5%), 61.1% (95% PI: 58.0-64.8%), 91.3% (95% PI: 85.4-94.6%) and 25.7% (95% PI: 23.5-28.3%) of its estimated maximum effect for fasting plasma glucose, haematocrit, serum creatinine and urinary albumin-creatinine ratio, respectively.
CONCLUSION


We demonstrate that doses higher than 10 mg could provide additional beneficial effects in haematocrit, systolic blood pressure, urinary albumin-creatinine ratio and uric acid, without obvious increases in the rate of adverse events. These results raise the question whether future outcome studies assessing the benefits of higher than currently registered dapagliflozin doses are merited.",2020,"We demonstrate that doses higher than 10 mg could provide additional beneficial effects in hematocrit, systolic blood pressure, urinary albumin creatinine ratio and uric acid, without obvious increases in the rate of adverse events.",[],"['dapagliflozin', 'Dapagliflozin']","['hematocrit, systolic blood pressure, urinary albumin creatinine ratio and uric acid', 'fasting plasma glucose, haematocrit, serum creatinine and urinary albumin-creatinine ratio', 'cardio-renal risk markers and adverse events', 'rate of adverse events']",[],"[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}]","[{'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0486293', 'cui_str': 'Albumin/creatinine ratio measurement'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0796205,"We demonstrate that doses higher than 10 mg could provide additional beneficial effects in hematocrit, systolic blood pressure, urinary albumin creatinine ratio and uric acid, without obvious increases in the rate of adverse events.","[{'ForeName': 'Jeroen V', 'Initials': 'JV', 'LastName': 'Koomen', 'Affiliation': 'Department Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Jasper', 'Initials': 'J', 'LastName': 'Stevens', 'Affiliation': 'Department Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Hiddo J L', 'Initials': 'HJL', 'LastName': 'Heerspink', 'Affiliation': 'Department Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.'}]",British journal of clinical pharmacology,['10.1111/bcp.14318']
204,31995812,Evaluating global brain connectivity as an imaging marker for depression: influence of preprocessing strategies and placebo-controlled ketamine treatment.,"Major depressive disorder (MDD) is associated with altered global brain connectivity (GBC), as assessed via resting-state functional magnetic resonance imaging (rsfMRI). Previous studies found that antidepressant treatment with ketamine normalized aberrant GBC changes in the prefrontal and cingulate cortices, warranting further investigations of GBC as a putative imaging marker. These results were obtained via global signal regression (GSR). This study is an independent replication of that analysis using a separate dataset. GBC was analyzed in 28 individuals with MDD and 22 healthy controls (HCs) at baseline, post-placebo, and post-ketamine. To investigate the effects of preprocessing, three distinct pipelines were used: (1) regression of white matter (WM)/cerebrospinal fluid (CSF) signals only (BASE); (2) WM/CSF + GSR (GSR); and (3) WM/CSF + physiological parameter regression (PHYSIO). Reduced GBC was observed in individuals with MDD only at baseline in the anterior and medial cingulate cortices, as well as in the prefrontal cortex only after regressing the global signal. Ketamine had no effect compared to baseline or placebo in either group in any pipeline. PHYSIO did not resemble GBC preprocessed with GSR. These results concur with several studies that used GSR to study GBC. Further investigations are warranted into disease-specific components of global fMRI signals that may drive these results and of GBCr as a potential imaging marker in MDD.",2020,"Reduced GBC was observed in individuals with MDD only at baseline in the anterior and medial cingulate cortices, as well as in the prefrontal cortex only after regressing the global signal.","['Major depressive disorder (MDD', '28 individuals with MDD and 22 healthy controls (HCs) at baseline, post']","['placebo', 'Ketamine', 'placebo-controlled ketamine', 'ketamine', 'white matter (WM)/cerebrospinal fluid (CSF) signals only (BASE); (2) WM/CSF\u2009+\u2009GSR (GSR); and (3) WM/CSF\u2009+\u2009physiological parameter regression (PHYSIO']","['GBC', 'Reduced GBC']","[{'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0682708'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0684321', 'cui_str': 'Regression'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}]",28.0,0.0521611,"Reduced GBC was observed in individuals with MDD only at baseline in the anterior and medial cingulate cortices, as well as in the prefrontal cortex only after regressing the global signal.","[{'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Kraus', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA. christoph.kraus@nih.gov.'}, {'ForeName': 'Anahit', 'Initials': 'A', 'LastName': 'Mkrtchian', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Bashkim', 'Initials': 'B', 'LastName': 'Kadriu', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Allison C', 'Initials': 'AC', 'LastName': 'Nugent', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Zarate', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Jennifer W', 'Initials': 'JW', 'LastName': 'Evans', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0624-0']
205,31995813,"Modafinil enhances cognitive, but not emotional conflict processing via enhanced inferior frontal gyrus activation and its communication with the dorsomedial prefrontal cortex.","Cognitive control regulates cognitive and emotional systems to facilitate goal-directed behavior in the context of task-irrelevant distractors. Cognitive control deficits contribute to residual functional impairments across psychiatric disorders and represent a promising novel treatment target. Translational evidence suggests that modafinil may enhance performance in executive functions; however, differential effects on regulatory control in cognitive and emotional domains have not been examined. The present pre-registered randomized-controlled pharmacological fMRI trial examined differential effects of modafinil (single-dose, 200 mg) on cognitive and emotional conflict processing. To further separate objective cognitive enhancing effects from subjective performance perception, a metacognitive paradigm was employed. Results indicated that modafinil specifically enhanced cognitive conflict performance and concomitantly increased activation in the inferior frontal gyrus and its functional communication with the dorsomedial prefrontal cortex. Exploratory analysis further revealed modafinil-enhanced basolateral amygdala reactivity to cognitive conflict, with stronger reactivity being associated with higher cognitive conflict performance. Whereas modafinil enhanced cognitive performance in the metacognitive paradigm, confidence indices remained unaffected. Overall, the present results suggest that modafinil has the potential to enhance cognitive conflict processing while leaving emotional conflict processing unaffected. On the neural level modafinil enhanced the recruitment of a network engaged in general conflict and regulatory control processes, whereas effects on the amygdala may reflect improved arousal-mediated attention processes for conflicting information. The pattern of cognitive enhancing effects in the absence of effects on affective processing suggests a promising potential to enhance cognitive control in clinical populations.",2020,"On the neural level modafinil enhanced the recruitment of a network engaged in general conflict and regulatory control processes, whereas effects on the amygdala may reflect improved arousal-mediated attention processes for conflicting information.",[],"['Modafinil', 'modafinil']","['cognitive performance', 'cognitive and emotional conflict processing', 'cognitive conflict performance']",[],"[{'cui': 'C0066677', 'cui_str': 'modafinil'}]","[{'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0009671', 'cui_str': 'Conflict'}]",,0.0288783,"On the neural level modafinil enhanced the recruitment of a network engaged in general conflict and regulatory control processes, whereas effects on the amygdala may reflect improved arousal-mediated attention processes for conflicting information.","[{'ForeName': 'Jialin', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'The Clinical Hospital of the Chengdu Brain Science Institute, MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'The Clinical Hospital of the Chengdu Brain Science Institute, MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Zhou', 'Affiliation': 'The Clinical Hospital of the Chengdu Brain Science Institute, MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Congcong', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'The Clinical Hospital of the Chengdu Brain Science Institute, MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Zhenyu', 'Initials': 'Z', 'LastName': 'Wei', 'Affiliation': 'The Clinical Hospital of the Chengdu Brain Science Institute, MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Xin', 'Affiliation': 'The Clinical Hospital of the Chengdu Brain Science Institute, MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'Daumann', 'Affiliation': 'LVR Clinics of Cologne, Cologne, Germany.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Daumann', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Keith M', 'Initials': 'KM', 'LastName': 'Kendrick', 'Affiliation': 'The Clinical Hospital of the Chengdu Brain Science Institute, MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Becker', 'Affiliation': 'The Clinical Hospital of the Chengdu Brain Science Institute, MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China. ben_becker@gmx.de.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0625-z']
206,30732459,Complete withdrawal is the most effective approach to reduce disability in patients with medication-overuse headache: A randomized controlled open-label trial.,"BACKGROUND


Medication-overuse headache leads to high disability and decreased quality of life, and the best approach for withdrawal has been debated.
AIM


To compare change in disability and quality of life between two withdrawal programs.
METHODS


We randomized medication-overuse headache patients to program A (two months without acute analgesics or migraine medications) or program B (two months with acute medications restricted to two days/week) in a prospective, outpatient study. At 6 and 12 months, we measured disability and headache burden by the Headache Under-Response to Treatment index (HURT). We estimated quality of life by EUROHIS-QOL 8-item at 2-, 6-, and 12-month follow-up. Primary endpoint was disability change at 12 months.
RESULTS


We included 72 medication-overuse headache patients with primary migraine and/or tension-type headache. Fifty nine completed withdrawal and 54 completed 12-month follow-up. At 12-month follow-up, 41 patients completed HURT and 38 completed EUROHIS-QOL 8-item. Disability reduction was 25% in program-A and 7% in program-B ( p = 0.027). Headache-burden reduction was 33% in program-A and 3% in program-B ( p = 0.005). Quality of life was increased by 8% in both programs without significant difference between the programs ( p = 0.30). At 2-month follow-up, quality of life increased significantly more in program-A than program-B ( p = 0.006).
CONCLUSION


Both withdrawal programs reduced disability and increased quality of life. Withdrawal without acute medication was the most effective in reducing disability in medication-overuse headache patients.
TRIAL REGISTRATION


Clinicaltrials.gov (NCT02903329).",2019,Quality of life was increased by 8% in both programs without significant difference between the programs ( p = 0.30).,"['patients with medication-overuse headache', 'Fifty nine completed withdrawal and 54 completed 12-month follow-up', '72 medication-overuse headache patients with primary migraine and/or tension-type headache']",['program A (two months without acute analgesics or migraine medications'],"['disability and quality of life', 'Quality of life', 'quality of life by EUROHIS-QOL 8-item', 'Disability reduction', 'quality of life', 'disability change', 'Headache-burden reduction', 'disability and headache burden by the Headache Under-Response to Treatment index (HURT', 'disability and increased quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0522254', 'cui_str': 'Analgesic Overuse Headache'}, {'cui': 'C3830128', 'cui_str': '59 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0033893', 'cui_str': 'Tension-Type Headache'}]","[{'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}]","[{'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0034380'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0521982', 'cui_str': 'Therapeutic response, function (observable entity)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",72.0,0.0472911,Quality of life was increased by 8% in both programs without significant difference between the programs ( p = 0.30).,"[{'ForeName': 'Mia', 'Initials': 'M', 'LastName': 'Nielsen', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet-Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Glostrup, Denmark.'}, {'ForeName': 'Louise Ninett', 'Initials': 'LN', 'LastName': 'Carlsen', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet-Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Glostrup, Denmark.'}, {'ForeName': 'Signe Bruun', 'Initials': 'SB', 'LastName': 'Munksgaard', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet-Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Glostrup, Denmark.'}, {'ForeName': 'Ida Maria Storm', 'Initials': 'IMS', 'LastName': 'Engelstoft', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet-Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Glostrup, Denmark.'}, {'ForeName': 'Rigmor Højland', 'Initials': 'RH', 'LastName': 'Jensen', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet-Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Glostrup, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Bendtsen', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet-Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Glostrup, Denmark.'}]",Cephalalgia : an international journal of headache,['10.1177/0333102419828994']
207,32318695,Effect of allopurinol on phosphocreatine recovery and muscle function in older people with impaired physical function: a randomised controlled trial.,"BACKGROUND


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


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


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


Allopurinol improved 6-min walk distance but not PCr recovery rate in older people with impaired physical function. Antioxidant strategies to improve muscle function for older people may need to be targeted at subgroups with high baseline oxidative stress.",2020,"Allopurinol improved 6-min walk distance (treatment effect 25 m [95% 4-46, P = 0.02]).","['older people with impaired physical performance', 'older people', 'recruited community-dwelling participants aged 65 and over with baseline 6-min walk distance of <400\xa0m and no contraindications to magnetic resonance imaging scanning', '124 participants were randomised, mean age 80 (SD 6) years', 'older people with impaired physical function']","['Allopurinol', 'allopurinol', 'placebo']","['post-exercise phosphocreatine (PCr) recovery rate', 'PCr recovery rate', '6-min walk distance, short physical performance battery (SPPB), lean body mass measured by bioimpedance, endothelial function and quality of life', 'endothelial function, quality of life, lean body mass or SPPB', 'skeletal muscle energetics and physical function', 'phosphocreatine recovery and muscle function', '6-min walk distance']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0031843', 'cui_str': 'PH'}]","[{'cui': 'C0002144', 'cui_str': 'Allopurinol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0031634', 'cui_str': 'fosfocreatine'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0231484', 'cui_str': 'Muscle function'}]",124.0,0.800177,"Allopurinol improved 6-min walk distance (treatment effect 25 m [95% 4-46, P = 0.02]).","[{'ForeName': 'Miles D', 'Initials': 'MD', 'LastName': 'Witham', 'Affiliation': 'Division of Molecular and Clinical Medicine, University of Dundee, Ninewells Hospital and Medical School, Dundee, UK.'}, {'ForeName': 'Clare L', 'Initials': 'CL', 'LastName': 'Clarke', 'Affiliation': 'Division of Molecular and Clinical Medicine, University of Dundee, Ninewells Hospital and Medical School, Dundee, UK.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Hutcheon', 'Affiliation': 'Division of Molecular and Clinical Medicine, University of Dundee, Ninewells Hospital and Medical School, Dundee, UK.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Gingles', 'Affiliation': 'Division of Molecular and Clinical Medicine, University of Dundee, Ninewells Hospital and Medical School, Dundee, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Gandy', 'Affiliation': 'Department of Medical Physics, Ninewells Hospital, NHS Tayside, Dundee, UK.'}, {'ForeName': 'Lukasz', 'Initials': 'L', 'LastName': 'Priba', 'Affiliation': 'Department of Medical Physics, Ninewells Hospital, NHS Tayside, Dundee, UK.'}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Nicholas', 'Affiliation': 'Department of Medical Physics, Ninewells Hospital, NHS Tayside, Dundee, UK.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Cavin', 'Affiliation': 'Department of Medical Physics, Ninewells Hospital, NHS Tayside, Dundee, UK.'}, {'ForeName': 'Deepa', 'Initials': 'D', 'LastName': 'Sumukadas', 'Affiliation': 'Department of Medicine for the Elderly, Ninewells Hospital, NHS Tayside, Dundee, UK.'}, {'ForeName': 'Allan D', 'Initials': 'AD', 'LastName': 'Struthers', 'Affiliation': 'Division of Molecular and Clinical Medicine, University of Dundee, Ninewells Hospital and Medical School, Dundee, UK.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'George', 'Affiliation': 'Division of Molecular and Clinical Medicine, University of Dundee, Ninewells Hospital and Medical School, Dundee, UK.'}]",Age and ageing,['10.1093/ageing/afaa061']
208,32318722,Home- or hospital-based monitoring to time frozen embryo transfer in the natural cycle? Patient-reported outcomes and experiences from the Antarctica-2 randomised controlled trial.,"STUDY QUESTION


What are the patient-reported outcomes (PROs) and patient-reported experiences (PREs) in home-based monitoring compared to those in hospital-based monitoring of ovulation for scheduling frozen-thawed embryo transfer (FET)?
SUMMARY ANSWER


Women undergoing either home-based or hospital-based monitoring experience an increase in anxiety/sadness symptoms over time, but women undergoing home-based monitoring felt more empowered during the treatment and classified the monitoring as more discreet compared to hospital-based monitoring.
WHAT IS KNOWN ALREADY


FET is at the heart of modern IVF. The two types of FET cycles that are mainly are used are artificial cycle FET, using artificial preparation of the endometrium with exogenous progesterone and oestrogen, and natural cycle FET (NC-FET). During a natural cycle FET, women visit the hospital repeatedly and receive an ovulation trigger to time FET (i.e. modified NC-FET or hospital-based monitoring). The previously published Antarctica randomised controlled trial (NTR 1586) showed that modified NC-FET is more cost-effective compared to artificial cycle FET. From the women's point of view a more natural approach using home-based monitoring of ovulation with LH urine tests to time FET may be desired (true NC-FET or home-based monitoring). Currently, the multicentre Antarctica-2 randomised controlled trial (RCT) is comparing the cost-effectiveness of home-based monitoring of ovulation with that of hospital-based monitoring of ovulation. The Antarctica-2 RCT enables us to study PROs, defined as the view of participating women of their healthcare status, and PREs, defined as the perception of the received care of participating women, in both FET strategies.
STUDY DESIGN, SIZE, DURATION


PROs and PREs were assessed alongside the Antarctica-2 RCT. PROs were assessed using the validated EuroQol-5D-5L questionnaire. Currently, there are no guidelines for assessing PREs in this population. Therefore, members of the Dutch Patient Organisation for Couples with Fertility Problems (FREYA) filled out an online survey and selected the following PREs to assess (i) anxiety about missing ovulation, (ii) perceived level of partner participation, (iii) level of discretion, (iv) feeling of empowerment and (v) satisfaction with treatment.
PARTICIPANTS/MATERIALS, SETTING, METHODS


Women participating in the RCT also participated in PRO and PRE assessment. We assessed PROs and PREs at three time points: (i) before randomisation, (ii) at the time of the FET and (iii) at the time of the pregnancy test. A sample size of 200 participants was needed to find a difference of 0.3 with a standard deviation in both groups of 0.7, an alpha of 5%, power of 80% and a drop-out rate of 10%. We performed mixed model analysis for between-group comparison of treatment and time effects.
MAIN RESULTS AND ROLE OF CHANCE


A total of 260 women were randomised. Of these, 132 women were treated with home-based monitoring and 128 women were treated with hospital-based monitoring. Data before randomisation were available for 232 women (home-based monitoring n = 116, hospital-based monitoring n = 116). For the PROs, we found a significant increase in anxiety/sadness symptoms over time (P < 0.001) in both groups. We found no treatment effect of home-based versus hospital-based monitoring for the PROs (P = 0.8). Concerning the PRES, we found that women felt more empowered during home-based monitoring (P = 0.001) and classified the home-based monitoring as more discreet (P = 0.000) compared to the hospital-based monitoring.
LIMITATIONS, REASONS FOR CAUTION


The results are applicable only to women undergoing NC-FET and not to women undergoing artificial cycle FET.
WIDER IMPLICATIONS OF THE FINDINGS


Apart from clinical outcomes, PROs and PREs are also of importance in clinical decision-making and to support tailoring treatment even more specifically to the wishes of patients. Measurement of PROs and PREs should therefore be incorporated in future clinical research.
STUDY FUNDING/COMPETING INTEREST(S)


The Antarctica-2 RCT is supported by a grant of the Netherlands Organisation for Health Research and Development (ZonMw 843002807). J.B. receives unconditional educational grants from Merck Serono and Ferring and is a member of the medical advisory board of Ferring. C.L. reports that his department receives unrestricted research grants from Ferring, Merck and Guerbet. E.G. receives personal fees from Titus Health Care outside submitted work. The remaining authors have no conflicts of interest.
TRIAL REGISTRATION NUMBER


Trial NL6414 (NTR6590).
TRIAL REGISTER DATE


23 July 2017.
DATE OF FIRST PATIENT’S ENROLMENT


10 April 2018.",2020,We found no treatment effect of home-based versus hospital-based monitoring for the PROs (P = 0.8).,"['200 participants', '132 women were treated with home-based monitoring and 128 women were treated with hospital-based monitoring', 'Women participating in the RCT also participated in PRO and PRE assessment', 'A total of 260 women were randomised', 'Women undergoing either', '23 July 2017', '232 women (home-based monitoring n\xa0=\u2009116, hospital-based monitoring n\xa0=\u2009116']","['Home- or hospital-based monitoring to time frozen embryo transfer', 'modified NC-FET', 'home-based or hospital-based monitoring experience']","['anxiety/sadness symptoms', 'PROs and PREs', 'level of partner participation, (iii) level of discretion, (iv) feeling of empowerment and (v) satisfaction']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517669', 'cui_str': '260'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0404110', 'cui_str': 'Frozen embryo transfer'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0016701', 'cui_str': 'Freezing'}, {'cui': 'C0013938', 'cui_str': 'Embryo transfer'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C3536794', 'cui_str': 'Unhappiness'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",260.0,0.0619653,We found no treatment effect of home-based versus hospital-based monitoring for the PROs (P = 0.8).,"[{'ForeName': 'T R', 'Initials': 'TR', 'LastName': 'Zaat', 'Affiliation': 'Amsterdam Reproduction and Development Research Institute, Center for Reproductive Medicine, Department of Obstetrics and Gynaecology, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, Netherlands.'}, {'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'de Bruin', 'Affiliation': ""Department of Obstetrics and Gynaecology, Jeroen Bosch Ziekenhuis, Henri Dunantstraat 1, 's-Hertogenbosch, Netherlands.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Goddijn', 'Affiliation': 'Amsterdam Reproduction and Development Research Institute, Center for Reproductive Medicine, Department of Obstetrics and Gynaecology, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Visser', 'Affiliation': 'Department of Obstetrics and Gynaecology, Amphia Ziekenhuis, Langendijk 75, Breda, Netherlands.'}, {'ForeName': 'E M', 'Initials': 'EM', 'LastName': 'Kaaijk', 'Affiliation': 'Department of Obstetrics and Gynaecology, OLVG Oost, Oosterpark 9, Amsterdam, Netherlands.'}, {'ForeName': 'C B', 'Initials': 'CB', 'LastName': 'Lambalk', 'Affiliation': 'Centre for Reproductive Medicine, Department of Obstetrics and Gynaecology, Amsterdam UMC, Vrije Universiteit Amsterdam, De Boelelaan 1117, Amsterdam, Netherlands.'}, {'ForeName': 'E R', 'Initials': 'ER', 'LastName': 'Groenewoud', 'Affiliation': 'Department of Obstetrics and Gynaecology, Noordwest Ziekenhuisgroep, Huisduinerweg 3, Den Helder, Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'van Wely', 'Affiliation': 'Amsterdam Reproduction and Development Research Institute, Center for Reproductive Medicine, Department of Obstetrics and Gynaecology, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, Netherlands.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Mol', 'Affiliation': 'Amsterdam Reproduction and Development Research Institute, Center for Reproductive Medicine, Department of Obstetrics and Gynaecology, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, Netherlands.'}]","Human reproduction (Oxford, England)",['10.1093/humrep/deaa040']
209,32071052,Early Bactericidal Activity Trial of Nitazoxanide for Pulmonary Tuberculosis.,"This study was conducted in treatment-naive adults with drug-susceptible pulmonary tuberculosis in Port-au-Prince, Haiti, to assess the safety, bactericidal activity, and pharmacokinetics of nitazoxanide (NTZ). This was a prospective phase II clinical trial in 30 adults with pulmonary tuberculosis. Twenty participants received 1 g of NTZ orally twice daily for 14 days. A control group of 10 participants received standard therapy over 14 days. The primary outcome was the change in time to culture positivity (TTP) in an automated liquid culture system. The most common adverse events seen in the NTZ group were gastrointestinal complaints and headache. The mean change in TTP in sputum over 14 days in the NTZ group was 3.2 h ± 22.6 h and was not statistically significant ( P  = 0.56). The mean change in TTP in the standard therapy group was significantly increased, at 134 h ± 45.2 h ( P  < 0.0001). The mean NTZ MIC for  Mycobacterium tuberculosis  isolates was 12.3 μg/ml; the mean NTZ maximum concentration ( C   max ) in plasma was 10.2 μg/ml. Negligible NTZ levels were measured in sputum. At the doses used, NTZ did not show bactericidal activity against  M. tuberculosis  Plasma concentrations of NTZ were below the MIC, and its negligible accumulation in pulmonary sites may explain the lack of bactericidal activity. (This study has been registered at ClinicalTrials.gov under identifier NCT02684240.).",2020,"The mean change in TTP in the standard therapy group was significantly increased, at 134 hours ± 45.2 (p<0.0001).","['30 adults with pulmonary tuberculosis', 'pulmonary tuberculosis', 'naïve adults with drug-susceptible pulmonary tuberculosis in Port-au-Prince, Haiti']","['nitazoxanide', 'nitazoxanide (NTZ).DesignThis', 'standard therapy', 'NTZ']","['safety, bactericidal activity and pharmacokinetics', 'mean change in TTP', 'mean NTZ plasma C max', 'mean change in TTP in sputum', 'change in time to culture positivity in an automated liquid culture system', 'gastrointestinal complaints and headache', 'mean NTZ minimum inhibitory concentration']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0041327', 'cui_str': 'Pulmonary Phthisis'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0231204', 'cui_str': 'Susceptible (qualifier value)'}, {'cui': 'C0452253', 'cui_str': 'Port (substance)'}, {'cui': 'C0018510', 'cui_str': 'Haiti'}]","[{'cui': 'C0068788', 'cui_str': 'nitazoxanide'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1436435', 'cui_str': 'NTZ'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0544570', 'cui_str': 'Bactericidal activity (observable entity)'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0034155', 'cui_str': 'Moschkowitz Disease'}, {'cui': 'C1436435', 'cui_str': 'NTZ'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0220814', 'cui_str': 'culture'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C1304698', 'cui_str': 'Liquid - descriptor'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0277786', 'cui_str': 'Presenting complaint'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0427978', 'cui_str': 'Minimum Inhibitory Concentration'}]",30.0,0.0719608,"The mean change in TTP in the standard therapy group was significantly increased, at 134 hours ± 45.2 (p<0.0001).","[{'ForeName': 'K F', 'Initials': 'KF', 'LastName': 'Walsh', 'Affiliation': 'Center for Global Health, Weill Cornell Medicine, New York, New York, USA kfw2001@med.cornell.edu.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'McAulay', 'Affiliation': 'Center for Global Health, Weill Cornell Medicine, New York, New York, USA.'}, {'ForeName': 'M H', 'Initials': 'MH', 'LastName': 'Lee', 'Affiliation': 'Center for Global Health, Weill Cornell Medicine, New York, New York, USA.'}, {'ForeName': 'S C', 'Initials': 'SC', 'LastName': 'Vilbrun', 'Affiliation': ""Groupe Haïtien d'Étude du Sarcome de Kaposi et des Infectieuses Opportunistes, Port-au-Prince, Haiti.""}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Mathurin', 'Affiliation': ""Groupe Haïtien d'Étude du Sarcome de Kaposi et des Infectieuses Opportunistes, Port-au-Prince, Haiti.""}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Jean Francois', 'Affiliation': 'Department of Laboratory Medicine and Pathology, Mayo Clinic, Phoenix, Arizona, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Zimmerman', 'Affiliation': 'Center for Discovery and Innovation, Hackensack Meridian Health, Nutley, New Jersey, USA.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Kaya', 'Affiliation': 'The Public Health Research Institute at the International Center for Public Health, New Jersey Medical School-Rutgers, The State University of New Jersey, Newark, New Jersey, USA.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Zhang', 'Affiliation': 'Department of Bioengineering and Therapeutic Sciences, University of California, San Francisco, California, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Saito', 'Affiliation': 'Department of Microbiology and Immunology, Weill Cornell Medicine, New York, New York, USA.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Ocheretina', 'Affiliation': 'Center for Global Health, Weill Cornell Medicine, New York, New York, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Savic', 'Affiliation': 'Center for Discovery and Innovation, Hackensack Meridian Health, Nutley, New Jersey, USA.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Dartois', 'Affiliation': 'The Public Health Research Institute at the International Center for Public Health, New Jersey Medical School-Rutgers, The State University of New Jersey, Newark, New Jersey, USA.'}, {'ForeName': 'W D', 'Initials': 'WD', 'LastName': 'Johnson', 'Affiliation': 'Center for Global Health, Weill Cornell Medicine, New York, New York, USA.'}, {'ForeName': 'J W', 'Initials': 'JW', 'LastName': 'Pape', 'Affiliation': ""Groupe Haïtien d'Étude du Sarcome de Kaposi et des Infectieuses Opportunistes, Port-au-Prince, Haiti.""}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Nathan', 'Affiliation': 'Department of Microbiology and Immunology, Weill Cornell Medicine, New York, New York, USA.'}, {'ForeName': 'D W', 'Initials': 'DW', 'LastName': 'Fitzgerald', 'Affiliation': 'Center for Global Health, Weill Cornell Medicine, New York, New York, USA.'}]",Antimicrobial agents and chemotherapy,['10.1128/AAC.01956-19']
210,30950565,"First-in-Human Pharmacokinetics and Safety Study of GSK3008356, a Selective DGAT1 Inhibitor, in Healthy Volunteers.","Diacylglycerol acyltransferase (DGAT) enzymes are involved in triglyceride (TG) biosynthesis. GSK3008356 is a potent and selective DGAT1 inhibitor that was administered orally in a 2-part study as double-blind, randomized, placebo-controlled single doses (SDs) and repeat doses (RDs) in healthy subjects to investigate its pharmacokinetics, pharmacodynamics, and safety/tolerability. Gastrointestinal adverse events were considered drug related and increased with dose and when given as multiple doses. In the SD part (n = 80), GSK3008356 was dosed from 5 to 200 mg as single or multiple doses per day. In the RD part (n = 24), GSK3008356 was dosed twice daily at 1, 3, and 10 mg for 14 days. GSK3008356 was generally well tolerated in the SD and RD parts. With single doses, absorption was rapid (median t max  , 0.5-1.5 hours), whereas single-day divided dosing resulted in higher t max  . Following 14-day RD oral administration, GSK3008356 was also rapidly absorbed, with median t max  ranging from 0.5 to 0.75 hours on days 1 and 14. Estimated mean half-life ranged from 1.5 to 4.6 hours with SDs and 1.3 to 2.1 hours with RDs. Exposure of GSK3008356 was largely dose proportional after RDs. At higher doses, there was a trend toward lower absolute postprandial TG level in some subjects.",2019,"With single doses, absorption was rapid (median t max  , 0.5-1.5 hours), whereas single-day divided dosing resulted in higher t max  .","['Healthy Volunteers', 'healthy subjects']",['placebo'],"['pharmacokinetics, pharmacodynamics, and safety/tolerability', 'Gastrointestinal adverse events', 'absolute postprandial TG level', 'tolerated']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.0342514,"With single doses, absorption was rapid (median t max  , 0.5-1.5 hours), whereas single-day divided dosing resulted in higher t max  .","[{'ForeName': 'Malek', 'Initials': 'M', 'LastName': 'Okour', 'Affiliation': 'GlaxoSmithKline, Collegeville, PA, USA.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Gress', 'Affiliation': 'GlaxoSmithKline, Collegeville, PA, USA.'}, {'ForeName': 'Xinyi', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'GlaxoSmithKline, Stevenage, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Rieman', 'Affiliation': 'GlaxoSmithKline, Collegeville, PA, USA.'}, {'ForeName': 'Jason D', 'Initials': 'JD', 'LastName': 'Lickliter', 'Affiliation': 'Nucleus Network, Melbourne, Victoria, Australia.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Brigandi', 'Affiliation': 'GlaxoSmithKline, Collegeville, PA, USA.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.691']
211,31183985,"Effect of Food on the Pharmacokinetics of 2 Formulations of DRL-17822, a Novel Selective Cholesteryl Ester Transfer Protein (CETP) Inhibitor, in Healthy Males.","DRL-17822 is a novel selective cholesteryl ester transfer protein inhibitor that showed an increased exposure, including an increase of >20-fold of maximum concentration and area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration, following a high-fat breakfast using a nanocrystal formulation. To reduce this effect of food, we generated an amorphous solid dispersion formulation. In this study, we compared the food effect of both formulations of DRL-17822 in a 2-part randomized, open-label, 4-way crossover study involving healthy adult males 18-45 years of age. In both parts of the study, 12 subjects received both formulations of DRL-17822 in both the fasted and fed states; a low-fat breakfast was provided in the first part and a high-fat breakfast in the second part. Compared to the nanocrystal formulation, the amorphous solid dispersion formulation substantially increased DRL-17822 exposure in the fasted state, including increased maximum concentration, area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration, and area under plasma concentration-time curve from time zero to infinity. Following a high-fat breakfast, DRL-17822 exposure was increased to a lesser extent in the amorphous solid dispersion formulation compared to the nanocrystal formulation (P < .001). Moreover, compared to the nanocrystal formulation the amorphous solid dispersion formulation caused a more pronounced increase in high-density lipoprotein in the fasted state. Consuming breakfast increased the effect of DRL-17822 on high-density lipoprotein. Taken together, our results indicate that by improving its formulation, DRL-17822 has a favorable exposure profile and therefore a more predictable food effect profile.",2019,"Following a high-fat breakfast, DRL-17822 exposure was increased to a lesser extent in the amorphous solid dispersion formulation compared to the nanocrystal formulation (P < .001).","['Healthy Males', 'healthy adult males 18-45 years of age']","['DRL-17822, a Novel Selective Cholesteryl Ester Transfer', 'Protein (CETP) Inhibitor', 'DRL-17822']","['high-density lipoprotein', 'maximum concentration, area under the plasma concentration-time curve']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0008387', 'cui_str': 'Cholesteryl Esters'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}]",,0.0166251,"Following a high-fat breakfast, DRL-17822 exposure was increased to a lesser extent in the amorphous solid dispersion formulation compared to the nanocrystal formulation (P < .001).","[{'ForeName': 'Annelieke C', 'Initials': 'AC', 'LastName': 'Kruithof', 'Affiliation': 'Centre for Human Drug Research, Leiden, The Netherlands.'}, {'ForeName': 'Rajinder', 'Initials': 'R', 'LastName': 'Kumar', 'Affiliation': ""Dr. Reddy's Laboratories Ltd, Hyderabad, India.""}, {'ForeName': 'Jasper', 'Initials': 'J', 'LastName': 'Stevens', 'Affiliation': 'Centre for Human Drug Research, Leiden, The Netherlands.'}, {'ForeName': 'Marieke L', 'Initials': 'ML', 'LastName': 'de Kam', 'Affiliation': 'Centre for Human Drug Research, Leiden, The Netherlands.'}, {'ForeName': 'Anirudh', 'Initials': 'A', 'LastName': 'Gautam', 'Affiliation': ""Dr. Reddy's Laboratories SA, Basel, Switzerland.""}, {'ForeName': 'Shanavas', 'Initials': 'S', 'LastName': 'Alikunju', 'Affiliation': ""Dr. Reddy's Laboratories Ltd, Hyderabad, India.""}, {'ForeName': 'Bijay K', 'Initials': 'BK', 'LastName': 'Padhi', 'Affiliation': ""Dr. Reddy's Laboratories Ltd, Hyderabad, India.""}, {'ForeName': 'Swati', 'Initials': 'S', 'LastName': 'Kulkarni', 'Affiliation': ""Dr. Reddy's Laboratories Ltd, Hyderabad, India.""}, {'ForeName': 'Rajeev S', 'Initials': 'RS', 'LastName': 'Raghuvanshi', 'Affiliation': ""Dr. Reddy's Laboratories Ltd, Hyderabad, India.""}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Gandhi', 'Affiliation': ""Dr. Reddy's Laboratories Ltd, Hyderabad, India.""}, {'ForeName': 'Jacobus', 'Initials': 'J', 'LastName': 'Burggraaf', 'Affiliation': 'Centre for Human Drug Research, Leiden, The Netherlands.'}, {'ForeName': 'Ingrid M C', 'Initials': 'IMC', 'LastName': 'Kamerling', 'Affiliation': 'Centre for Human Drug Research, Leiden, The Netherlands.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.707']
212,32317591,Potential for Lung Recruitment and Ventilation-Perfusion Mismatch in Patients With the Acute Respiratory Distress Syndrome From Coronavirus Disease 2019.,"OBJECTIVES


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


Prospective crossover physiologic study.
SETTING


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


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


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


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


In patients with acute respiratory distress syndrome from coronavirus disease 2019, potential for lung recruitment presents large variability, while elevated dead space fraction may be a specific pathophysiological trait. These findings may guide selection of personalized mechanical ventilation settings.",2020,"At higher positive end-expiratory pressure, respiratory mechanics did not change significantly: compliance remained relatively high with low driving pressure.","['Patients With the Acute Respiratory Distress Syndrome From Coronavirus Disease 2019', 'patients with acute respiratory distress syndrome', 'acute respiratory distress syndrome from coronavirus disease 2019', 'ICU of a university-affiliated hospital from northern Italy dedicated to care of patients with confirmed diagnosis of coronavirus disease 2019', 'Ten intubated patients with acute respiratory distress syndrome and confirmed diagnosis of coronavirus disease 2019', 'Severe cases of coronavirus disease 2019 develop the acute respiratory distress syndrome, requiring admission to the ICU']",['Lung Recruitment and Ventilation-Perfusion Mismatch'],"['arterial blood gases, respiratory mechanics, ventilation inhomogeneity, and potential for lung recruitment by electrical impedance tomography', 'respiratory rate and tidal volume', 'ventilation-perfusion mismatch']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]","[{'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C2721740', 'cui_str': 'Ventilation perfusion mismatch'}]","[{'cui': 'C0150411', 'cui_str': 'Analysis of arterial blood gases and pH'}, {'cui': 'C0035230', 'cui_str': 'Breathing Mechanics'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0162537', 'cui_str': 'Impedance'}, {'cui': 'C0040395', 'cui_str': 'Diagnostic tomography'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C2721740', 'cui_str': 'Ventilation perfusion mismatch'}]",10.0,0.127794,"At higher positive end-expiratory pressure, respiratory mechanics did not change significantly: compliance remained relatively high with low driving pressure.","[{'ForeName': 'Tommaso', 'Initials': 'T', 'LastName': 'Mauri', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Spinelli', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Eleonora', 'Initials': 'E', 'LastName': 'Scotti', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Colussi', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Maria Cristina', 'Initials': 'MC', 'LastName': 'Basile', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Crotti', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Tubiolo', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Tagliabue', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Zanella', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Grasselli', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Pesenti', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}]",Critical care medicine,['10.1097/CCM.0000000000004386']
213,30650260,"Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of ELX-02, a Potential Treatment for Genetic Disorders Caused by Nonsense Mutations, in Healthy Volunteers.","ELX-02 is an investigational synthetic eukaryotic ribosome-selective glycoside optimized as a translational read-through molecule that induces read through of nonsense mutations, resulting in normally localized full-length functional proteins. ELX-02 is being developed as a therapy for genetic diseases caused by nonsense mutations. Two phase 1a, randomized, double-blind placebo-controlled, single-ascending-dose studies were conducted in healthy human subjects to evaluate the safety and pharmacokinetics of ELX-02. Single subcutaneously injected doses of ELX-02 between 0.3 mg/kg and 7.5 mg/kg showed an acceptable safety profile without severe or serious drug-related adverse events, including a lack of renal and ototoxicity events. Injection of ELX-02 resulted in a rapid time to peak concentration and elimination phase, with complete elimination from the vascular compartment within 10 hours. ELX-02 area under the concentration-time curve to infinity showed dose-exposure linearity (24-fold increase for a 25-fold dose increase), and the maximum concentration showed dose proportionality (17-fold increase for a 25-fold increase). The mean apparent volume of distribution was dose dependent, suggesting an increased distribution and tissue uptake of ELX-02 at higher doses. The primary route of excretion was in the urine, with the majority of the compound excreted unchanged. These results support the evaluation of the safety, pharmacokinetics, and efficacy of repeat dosing in future studies.",2019,"The mean apparent volume of distribution was dose dependent, suggesting an increased distribution and tissue uptake of ELX-02 at higher doses.","['Healthy Volunteers', 'healthy human subjects']","['ELX-02', 'placebo']","['renal and ototoxicity events', 'acceptable safety profile without severe or serious drug-related adverse events', 'Safety, Tolerability, and Pharmacokinetics', 'ELX-02 area under the concentration-time curve', 'safety and pharmacokinetics of ELX-02', 'distribution and tissue uptake of ELX-02']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0080105', 'cui_str': 'Human Subjects'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0235280', 'cui_str': 'Ototoxicity (disorder)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}]",,0.172092,"The mean apparent volume of distribution was dose dependent, suggesting an increased distribution and tissue uptake of ELX-02 at higher doses.","[{'ForeName': 'Andi', 'Initials': 'A', 'LastName': 'Leubitz', 'Affiliation': 'Eloxx Pharmaceuticals, Rehovot, Israel.'}, {'ForeName': 'Anat', 'Initials': 'A', 'LastName': 'Frydman-Marom', 'Affiliation': 'Eloxx Pharmaceuticals, Rehovot, Israel.'}, {'ForeName': 'Neal', 'Initials': 'N', 'LastName': 'Sharpe', 'Affiliation': 'Eloxx Pharmaceuticals, Waltham, MA, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'van Duzer', 'Affiliation': 'Eloxx Pharmaceuticals, Waltham, MA, USA.'}, {'ForeName': 'Kathleen C M', 'Initials': 'KCM', 'LastName': 'Campbell', 'Affiliation': 'Audiology consultant to Eloxx Pharmaceuticals, Waltham, MA, USA.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Vanhoutte', 'Affiliation': 'SGS Life Sciences, Clinical Pharmacology Unit, Antwerp, Belgium.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.647']
214,32312713,Randomized Phase IIB Trial of the Lignan Secoisolariciresinol Diglucoside in Premenopausal Women at Increased Risk for Development of Breast Cancer.,"We conducted a multiinstitutional, placebo-controlled phase IIB trial of the lignan secoisolariciresinol diglucoside (SDG) found in flaxseed. Benign breast tissue was acquired by random periareolar fine needle aspiration (RPFNA) from premenopausal women at increased risk for breast cancer. Those with hyperplasia and ≥2% Ki-67 positive cells were eligible for randomization 2:1 to 50 mg SDG/day (Brevail) versus placebo for 12 months with repeat bio-specimen acquisition. The primary endpoint was difference in change in Ki-67 between randomization groups. A total of 180 women were randomized, with 152 ultimately evaluable for the primary endpoint. Median baseline Ki-67 was 4.1% with no difference between arms. Median Ki-67 change was -1.8% in the SDG arm ( P  = 0.001) and -1.2% for placebo ( P  = 0.034); with no significant difference between arms. As menstrual cycle phase affects proliferation, secondary analysis was performed for 117 women who by progesterone levels were in the same phase of the menstrual cycle at baseline and off-study tissue sampling. The significant Ki-67 decrease persisted for SDG (median = -2.2%;  P  = 0.002) but not placebo (median = -1.0%). qRT-PCR was performed on 77 pairs of tissue specimens. Twenty-two had significant ERα gene expression changes (<0.5 or >2.0) with 7 of 10 increases in placebo and 10 of 12 decreases for SDG ( P  = 0.028), and a difference between arms ( P  = 0.017). Adverse event incidence was similar in both groups, with no evidence that 50 mg/day SDG is harmful. Although the proliferation biomarker analysis showed no difference between the treatment group and the placebo, the trial demonstrated use of SDG is tolerable and safe.",2020,Median Ki-67 change was -1.8% in the SDG arm (P=0.001) and -1.2% for placebo (P=0.034); with no significant difference between arms.,"['Pre-menopausal Women at Increased Risk for Development of Breast Cancer', '117 women who by progesterone levels', '180 women were randomized, with 152 ultimately evaluable for the primary endpoint', 'Those with hyperplasia and ≥2% Ki-67 positive cells']","['SDG', 'RT-qPCR', 'Lignan Secoisolariciresinol Diglucoside', 'random periareolar fine needle aspiration (RPFNA', 'lignan secoisolariciresinol diglucoside (SDG', 'placebo']","['SDG', 'change in Ki-67', 'Adverse event incidence', 'ERα gene expression changes', 'Median Ki-67 change', 'Median baseline Ki-67']","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0428409', 'cui_str': 'Progesterone level'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0020507', 'cui_str': 'Hyperplasia'}, {'cui': 'C0439178', 'cui_str': '% positive cells'}]","[{'cui': 'C0290196', 'cui_str': 'secoisolariciresinol diglucoside'}, {'cui': 'C1709846', 'cui_str': 'Real-Time PCR'}, {'cui': 'C0064971', 'cui_str': 'Lignans'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1510483', 'cui_str': 'Fine needle aspiration biopsy - action'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0290196', 'cui_str': 'secoisolariciresinol diglucoside'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",180.0,0.408017,Median Ki-67 change was -1.8% in the SDG arm (P=0.001) and -1.2% for placebo (P=0.034); with no significant difference between arms.,"[{'ForeName': 'Carol J', 'Initials': 'CJ', 'LastName': 'Fabian', 'Affiliation': 'Department of Internal Medicine, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Seema A', 'Initials': 'SA', 'LastName': 'Khan', 'Affiliation': 'Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Judy E', 'Initials': 'JE', 'LastName': 'Garber', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Dooley', 'Affiliation': 'University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma.'}, {'ForeName': 'Lisa D', 'Initials': 'LD', 'LastName': 'Yee', 'Affiliation': 'Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Jennifer R', 'Initials': 'JR', 'LastName': 'Klemp', 'Affiliation': 'Department of Internal Medicine, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Nydegger', 'Affiliation': 'Department of Internal Medicine, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Kandy R', 'Initials': 'KR', 'LastName': 'Powers', 'Affiliation': 'Department of Internal Medicine, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Amy L', 'Initials': 'AL', 'LastName': 'Kreutzjans', 'Affiliation': 'Department of Internal Medicine, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Carola M', 'Initials': 'CM', 'LastName': 'Zalles', 'Affiliation': 'Department of Pathology, Boca Raton Hospital, Boca Raton, Florida.'}, {'ForeName': 'Trina', 'Initials': 'T', 'LastName': 'Metheny', 'Affiliation': 'Department of Internal Medicine, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Teresa A', 'Initials': 'TA', 'LastName': 'Phillips', 'Affiliation': 'Department of Internal Medicine, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Jinxiang', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': 'Department of Biostatistics & Data Science, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Devin C', 'Initials': 'DC', 'LastName': 'Koestler', 'Affiliation': 'Department of Biostatistics & Data Science, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Prabhakar', 'Initials': 'P', 'LastName': 'Chalise', 'Affiliation': 'Department of Biostatistics & Data Science, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Nanda Kumar', 'Initials': 'NK', 'LastName': 'Yellapu', 'Affiliation': 'Department of Biostatistics & Data Science, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Jernigan', 'Affiliation': 'University of Kansas Cancer Center, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Brian K', 'Initials': 'BK', 'LastName': 'Petroff', 'Affiliation': 'Veterinary Diagnostic Laboratory, Michigan State University, Lansing, Michigan.'}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Hursting', 'Affiliation': 'Department of Nutrition, University of North Carolina, Chapel Hill, North Carolina.'}, {'ForeName': 'Bruce F', 'Initials': 'BF', 'LastName': 'Kimler', 'Affiliation': 'Department of Radiation Oncology, University of Kansas Medical Center, Kansas City, Kansas. bkimler@kumc.edu.'}]","Cancer prevention research (Philadelphia, Pa.)",['10.1158/1940-6207.CAPR-20-0050']
215,31811662,Hypoglycaemia is reduced with use of inhaled Technosphere ®  Insulin relative to insulin aspart in type 1 diabetes mellitus.,"AIM


To evaluate the effect of final HbA 1c  levels on the incidences of hypoglycaemia in participants with type 1 diabetes treated with inhaled Technosphere ®  Insulin or subcutaneous insulin aspart, reported in alignment with the International Hypoglycaemia Study Group recommendations.
METHODS


In the randomized, phase 3, multicentre AFFINITY-1 study, adults (N = 375) who had type 1 diabetes for ≥ 12 months and an HbA 1c  level of 58-86 mmol/mol (7.5-10.0%) were randomized to receive basal insulin plus either inhaled Technosphere Insulin or subcutaneous insulin aspart. This was a post-hoc regression analysis on a subset (N = 279) of the randomized AFFINITY-1 cohort for whom baseline and end-of-treatment HbA 1c  values were reported. Primary outcome measures were incidence and event rates for levels 1, 2 and 3 hypoglycaemia, respectively defined as blood glucose levels of ≤ 3.9 mmol/l, < 3.0 mmol/l or requiring external assistance for recovery.
RESULTS


Participants treated with Technosphere Insulin experienced statistically significantly fewer level 1 and 2 hypoglycaemic events and a lower incidence of level 3 hypoglycaemia than participants treated with insulin aspart. The lower rate of hypoglycaemia with Technosphere Insulin was observed across the range of end-of-treatment HbA 1c  levels. Technosphere Insulin was associated with higher rates of hypoglycaemia 30-60 min after meals, but significantly lower rates 2-6 h after meals.
CONCLUSIONS


Participants using Technosphere Insulin experienced clinically non-inferior glycaemic control and lower hypoglycaemia rates across a range of HbA 1c  levels compared with participants receiving insulin aspart. ClinicalTrials.gov: NCT01445951.",2020,"Technosphere Insulin was associated with higher rates of hypoglycaemia 30-60 min after meals, but significantly lower rates 2-6 h after meals.
","['participants with type 1 diabetes treated with inhaled Technosphere ®  Insulin or subcutaneous insulin aspart, reported in alignment with the International Hypoglycaemia Study Group recommendations', 'adults (N\xa0=\xa0375) who had type 1 diabetes for ≥\xa012\xa0months and an HbA 1c  level of 58-86\xa0mmol/mol (7.5-10.0']","['final HbA 1c  levels', 'insulin aspart', 'basal insulin plus either inhaled Technosphere Insulin or subcutaneous insulin aspart']","['hypoglycaemia rates', 'level 1 and 2 hypoglycaemic events', 'level 3 hypoglycaemia', 'incidence and event rates for levels 1, 2 and 3 hypoglycaemia, respectively defined as blood glucose levels of ≤\xa03.9 mmol/l, <\xa03.0 mmol/l or requiring external assistance for recovery', 'Hypoglycaemia', 'rate of hypoglycaemia with Technosphere Insulin', 'hypoglycaemia']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0123677', 'cui_str': 'Insulin, Aspart, Human'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517745', 'cui_str': '375 (qualifier value)'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}, {'cui': 'C4517859', 'cui_str': 'Seven point five'}]","[{'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0123677', 'cui_str': 'Insulin, Aspart, Human'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C1522438', 'cui_str': 'SC use'}]","[{'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0456947', 'cui_str': 'Level 1 (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0456949', 'cui_str': 'Level 3 (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0428554', 'cui_str': 'Blood glucose result - finding'}, {'cui': 'C4517698', 'cui_str': '3.9 (qualifier value)'}, {'cui': 'C1532563', 'cui_str': 'umol/mL'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}]",,0.118406,"Technosphere Insulin was associated with higher rates of hypoglycaemia 30-60 min after meals, but significantly lower rates 2-6 h after meals.
","[{'ForeName': 'E R', 'Initials': 'ER', 'LastName': 'Seaquist', 'Affiliation': 'University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Blonde', 'Affiliation': 'Ochsner Medical Center, New Orleans, LA, USA.'}, {'ForeName': 'J B', 'Initials': 'JB', 'LastName': 'McGill', 'Affiliation': 'Washington University School of Medicine, St Louis, MO, USA.'}, {'ForeName': 'S R', 'Initials': 'SR', 'LastName': 'Heller', 'Affiliation': 'University of Sheffield, Sheffield, UK.'}, {'ForeName': 'D M', 'Initials': 'DM', 'LastName': 'Kendall', 'Affiliation': 'MannKind Corporation, Westlake Village, CA, USA.'}, {'ForeName': 'J B', 'Initials': 'JB', 'LastName': 'Bumpass', 'Affiliation': 'MannKind Corporation, Westlake Village, CA, USA.'}, {'ForeName': 'F M', 'Initials': 'FM', 'LastName': 'Pompilio', 'Affiliation': 'MannKind Corporation, Westlake Village, CA, USA.'}, {'ForeName': 'M L', 'Initials': 'ML', 'LastName': 'Grant', 'Affiliation': 'MannKind Corporation, Westlake Village, CA, USA.'}]",Diabetic medicine : a journal of the British Diabetic Association,['10.1111/dme.14202']
216,32316758,"Early rehabilitation in cardiology - heart failure: The ERIC-HF protocol, a novel intervention to decompensated heart failure patients rehabilitation.","BACKGROUND


Decompensated heart failure patients are characterised by functional dependence and low exercise tolerance. Aerobic exercise can improve symptoms, functional capacity and an increase in exercise tolerance. However, the benefits of early rehabilitation have not yet been validated.
OBJECTIVE


To evaluate the safety and feasibility of an aerobic exercise training programme in functional capacity of decompensated heart failure patients.
METHODOLOGY


A single centre, parallel, randomised controlled, open label trial, with 100 patients. The training group (TG,  n =50) performed the training protocol and the control group (CG,  n =50) performed the usual rehabilitation procedures. The London chest activity of daily living (LCADL) scale, the Barthel index (BI) and the 6 minute walking test (6MWT) at discharge were used to evaluate the efficacy of the protocol. Safety was measured by the existence of adverse events.
RESULTS


The mean age of the patients was 70 years, 20% were New York Heart Association (NYHA) class IV and 80% NYHA class III at admission. The major heart failure aetiology was ischaemic (35 patients) and valvular disease (25 patients). There were no significant differences between groups at baseline in terms of sociodemographic or pathophysiological characteristics. There was a statistically significant difference of 54.2 meters for the training group ( P =0.026) in the 6MWT and at LCADL 12 versus 16 ( P =0.003), but the BI did not: 96 versus 92 ( P =0.072). No major adverse events occurred.
CONCLUSIONS


The training protocol demonstrated safety and efficacy, promoting functional capacity. This study elucidated about the benefits of a systematised implementation of physical exercise during the patient's clinical stabilisation phase, which had not yet been demonstrated.Trial registration: Clinicaltrials.gov NCT03838003, URL: https://clinicaltrials.gov/ct2/show/NCT03838003.",2020,"There was a statistically significant difference of 54.2 meters for the training group ( P =0.026) in the 6MWT and at LCADL 12 versus 16 ( P =0.003), but the BI did not: 96 versus 92 ( P =0.072).","['100 patients', 'The mean age of the patients was 70 years, 20% were New York Heart Association (NYHA) class IV and 80% NYHA class III at admission', 'cardiology - heart failure', 'decompensated heart failure patients rehabilitation', 'major heart failure aetiology was ischaemic (35 patients) and valvular disease (25 patients', 'Decompensated heart failure patients', 'decompensated heart failure patients']","['physical exercise', 'aerobic exercise training programme', 'Aerobic exercise', 'training protocol and the control group (CG,  n =50) performed the usual rehabilitation procedures']","['Safety', 'sociodemographic or pathophysiological characteristics', 'exercise tolerance', 'London chest activity of daily living (LCADL) scale, the Barthel index (BI) and the 6 minute walking test (6MWT', 'safety and efficacy, promoting functional capacity']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0441888', 'cui_str': 'Class 4'}, {'cui': 'C0441887', 'cui_str': 'Class 3'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0026265', 'cui_str': 'Mitral valve disorder'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0162521', 'cui_str': 'Exercise tolerance'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}]",,0.0509502,"There was a statistically significant difference of 54.2 meters for the training group ( P =0.026) in the 6MWT and at LCADL 12 versus 16 ( P =0.003), but the BI did not: 96 versus 92 ( P =0.072).","[{'ForeName': 'Bruno Miguel', 'Initials': 'BM', 'LastName': 'Delgado', 'Affiliation': 'Porto University, Instituto de Ciencias Biomedicas Abel Salazar, Portugal.'}, {'ForeName': 'Ivo', 'Initials': 'I', 'LastName': 'Lopes', 'Affiliation': 'Cardiology Department of Centro Hospitalar do Porto, Hospital de St António Largo, Prof Abel Salazar, Portugal.'}, {'ForeName': 'Bárbara', 'Initials': 'B', 'LastName': 'Gomes', 'Affiliation': 'Rehabilitation Department, Escola Superior de Enfermagem do Porto, Portugal.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Novo', 'Affiliation': 'NursID, Cintesis, Portugal.'}]",European journal of cardiovascular nursing : journal of the Working Group on Cardiovascular Nursing of the European Society of Cardiology,['10.1177/1474515120913806']
217,31641203,A secondary analysis of testosterone and electrically evoked resistance training versus testosterone only (TEREX-SCI) on untrained muscles after spinal cord injury: a pilot randomized clinical trial.,"STUDY DESIGN


Secondary analysis of a clinical trial.
OBJECTIVES


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


Medical research center.
METHODS


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


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


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


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


Total and absolute gluteus maximus m. (14%, P = ","[{'ForeName': 'Ashraf S', 'Initials': 'AS', 'LastName': 'Gorgey', 'Affiliation': 'Spinal Cord Injury and Disorders, Hunter Holmes McGuire VA Medical Center, Richmond, VA, USA. ashraf.gorgey@va.gov.'}, {'ForeName': 'Sally M', 'Initials': 'SM', 'LastName': 'Abilmona', 'Affiliation': 'Spinal Cord Injury and Disorders, Hunter Holmes McGuire VA Medical Center, Richmond, VA, USA.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Sima', 'Affiliation': 'Department of Biostatistics, School of Medicine Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Refka E', 'Initials': 'RE', 'LastName': 'Khalil', 'Affiliation': 'Spinal Cord Injury and Disorders, Hunter Holmes McGuire VA Medical Center, Richmond, VA, USA.'}, {'ForeName': 'Rehan', 'Initials': 'R', 'LastName': 'Khan', 'Affiliation': 'Radiology Service, Hunter Holmes McGuire VA Medical Center, Richmond, VA, USA.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Adler', 'Affiliation': 'Endocrinology Section Hunter Holmes McGuire VA Medical Center, Richmond, VA, USA.'}]",Spinal cord,['10.1038/s41393-019-0364-3']
218,32312333,"Effect of garlic powder supplementation on hepatic steatosis, liver enzymes and lipid profile in patients with non-alcoholic fatty liver disease: a double-blind randomised controlled clinical trial.","Non-alcoholic fatty liver disease (NAFLD) includes a range of disorders from simple steatosis to non-alcoholic steatohepatitis. There is no proven drug treatment for NAFLD, and diet modification is considered part of the main line of treatment for this disease. The aim of this study was to investigate the efficacy of garlic supplementation in NAFLD patients. The effect of garlic powder supplementation on hepatic steatosis, liver enzymes and lipid profile was investigated in NAFLD patients. Ninety NAFLD patients were randomly assigned to take either a garlic powder supplement or a placebo for 12 weeks. The treatment group received four tablets of garlic daily (each tablet contained 400 mg garlic powder). The control group received four tablets of placebo (each placebo contained 400 mg starch). At the end of the study, hepatic steatosis was significantly reduced in the treatment group compared with the control group (P = 0·001). In addition, a significant decrease was seen in the serum concentration of alanine transaminase (P < 0·001), aspartate transaminase (P = 0·002), γ-glutamyltransferase (P = 0·003) as well as total cholesterol (P = 0·009), TAG (P < 0·001), HDL-cholesterol (P < 0·001) and LDL-cholesterol (P = 0·01) in the treatment group compared with the control group. No significant difference was seen between the two groups in serum concentration of alkaline phosphatase. Overall, garlic powder supplementation improved hepatic features and lipid profile among NAFLD patients.",2020,No significant difference was seen between the two groups in serum concentration of alkaline phosphatase.,"['NAFLD patients', 'Ninety NAFLD patients', 'patients with non-alcoholic fatty liver disease']","['garlic powder supplement or a placebo', 'garlic daily (each tablet contained 400 mg garlic powder', 'placebo (each placebo contained 400 mg starch', 'garlic powder supplementation', 'garlic supplementation']","['gamma-glutamyltransferase', 'total cholesterol', 'serum concentration of alkaline phosphatase', 'hepatic steatosis', 'high-density lipoprotein-cholesterol', 'hepatic features and lipid profile', 'serum concentration of alanine transaminase', 'triglyceride', 'low-density lipoprotein-cholesterol', 'aspartate transaminase', 'hepatic steatosis, liver enzymes, and lipid profile']","[{'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816959', 'cui_str': '90'}]","[{'cui': 'C1119842', 'cui_str': 'GARLIC POWDER'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0331590', 'cui_str': 'Allium ameloprasum'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0038179', 'cui_str': 'Starch'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0017040', 'cui_str': 'Gamma-glutamyltransferase'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0002059', 'cui_str': 'Alkaline phosphatase'}, {'cui': 'C0015695', 'cui_str': 'Fatty Liver'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme'}]",,0.54422,No significant difference was seen between the two groups in serum concentration of alkaline phosphatase.,"[{'ForeName': 'Abbas Ali', 'Initials': 'AA', 'LastName': 'Sangouni', 'Affiliation': 'Student Research Committee, Department of Nutrition, Urmia University of Medical Sciences, PO Box 5756115111, West Azarbaijan Province, Urmia, Iran.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Mohammad Hosseini Azar', 'Affiliation': 'Gastroenterology and Hepatology Subdivision of Internal Medicine Department, Imam Khomeini Hospital, School of Medicine, Urmia University of Medical Sciences, PO Box 5756115111, West Azarbaijan Province, Urmia, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Alizadeh', 'Affiliation': 'Food and Beverages Safety Research Center, Department of Nutrition, School of Medicine, Urmia University of Medical Sciences, PO Box 5756115111, West Azarbaijan Province, Urmia, Iran.'}]",The British journal of nutrition,['10.1017/S0007114520001403']
219,32114933,Self-directed usage of an in-home exergame after a supervised telerehabilitation training program for older adults with lower-limb amputation.,"BACKGROUND


While home-based exergames help overcome accessibility barriers to rehabilitation, it is unclear what constitutes effective intervention design in using exergames to support self-efficacy and engagement.
OBJECTIVE


Examine usage of an in-home exergame, compared to control, unsupervised after supervised training by older persons with lower-limb amputation.
STUDY DESIGN


Secondary analysis of a multi-site parallel evaluator-masked randomized control trial.
METHODS


WiiNWalk uses the WiiFit and teleconferencing for in-home group-based exergame therapy with clinical supervision. Participants engaged in a 4-week supervised training phase followed by a 4-week unsupervised phase in experimental (WiiNWalk) and attention control groups. Usage between phases and between groups was compared using unsupervised/supervised ratio of session count (over 4 weeks) and session time (mean min/session over 4 weeks) for each phase.
RESULTS


Participants: n=36 experimental, n=28 control, unilateral lower-limb amputation, age > 50 years, prosthesis usage ≥ 2 hours/day. Session count ratio unsupervised/supervised, median and interquartile range (IQR), was less than parity ( p <0.01) for experimental (0.25, IQR 0.00 -0.68) and control (0.18, IQR 0.00 -0.67) groups, with no different between groups ( p =0.92). Experimental session time unsupervised/supervised showed consistency (1.12, IQR 0.80 -1.41) between phases ( p =0.24); control showed lower (0.76, IQR 0.57 -1.08) ratios compared to experimental ( p =0.027).
CONCLUSIONS


Unsupervised exercise duration remained consistent with supervised, but frequency was reduced. Social and clinical guidance features may remain necessary for sustained lower-limb amputation exergame engagement at home.
CLINICAL RELEVANCE


This study provides context regarding when prosthesis users are more likely to use exergames such as Wii Fit for exercise therapy. Clinicians may consider our results when applying exergames in their practice or when developing new exergame intervention strategies.",2020,"Experimental session time unsupervised/supervised showed consistency (1.12, IQR 0.80 -1.41) between phases ( p =0.24); control showed lower (0.76, IQR 0.57 -1.08) ratios compared to experimental ( p =0.027).
","['older persons with lower-limb amputation', 'Participants', 'older adults with lower-limb amputation', 'n=36 experimental, n=28 control, unilateral lower-limb amputation, age']",['4-week supervised training phase followed by a 4-week unsupervised phase in experimental (WiiNWalk) and attention control groups'],"['Session count ratio unsupervised/supervised, median and interquartile range (IQR']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0337308', 'cui_str': 'Amputation of lower limb (procedure)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}]",,0.0279555,"Experimental session time unsupervised/supervised showed consistency (1.12, IQR 0.80 -1.41) between phases ( p =0.24); control showed lower (0.76, IQR 0.57 -1.08) ratios compared to experimental ( p =0.027).
","[{'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Tao', 'Affiliation': 'The University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Miller', 'Affiliation': 'The University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Janice J', 'Initials': 'JJ', 'LastName': 'Eng', 'Affiliation': 'The University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Lindstrom', 'Affiliation': 'University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Bita', 'Initials': 'B', 'LastName': 'Imam', 'Affiliation': 'The University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Payne', 'Affiliation': 'Western University, London, ON, Canada.'}]",Prosthetics and orthotics international,['10.1177/0309364620906272']
220,32317213,Delirium in intensive care: A stepped-wedge cluster randomised controlled trial for a nurse-led intervention to reduce the incidence and duration of delirium among adults admitted to the intensive care unit (protocol).,"BACKGROUND


Delirium is an acute disorder of attention and cognition with the highest rates among adults receiving intensive care. An acute episode of delirium is associated with morbidity and mortality, as well as a significant psychological sequela. Importantly, an increasing body of evidence supports the benefit of nonpharmacological, nurse-led interventions to reduce the incidence and duration of delirium among adults cared for in the intensive care unit (ICU).
OBJECTIVES


This study will evaluate the impact of a nursing-led delirium prevention protocol that is aimed at reducing the incidence and duration of delirium among adults admitted to the ICU. The delirium prevention nursing protocol specifically targets risk factors for delirium.
STUDY PLAN


A stepped-wedge cluster randomised controlled trial approach will be used to assess the effectiveness of the nurse-led intervention, in four adult ICUs across the South Western Sydney Local Health District (SWS-LHD), over a 12-month period. The primary outcomes of interest are (i) the incidence of delirium before and after the implementation of the nurse-led intervention and (ii) the number of delirium-free days during an ICU stay, before and after the implementation of the nurse-led intervention.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry (ANZCTR): (ACTRN12618000411246p).",2020,"A stepped-wedge cluster randomised controlled trial approach will be used to assess the effectiveness of the nurse-led intervention, in four adult ICUs across the South Western Sydney Local Health District (SWS-LHD), over a 12-month period.","['four adult ICUs across the South Western Sydney Local Health District (SWS-LHD), over a 12-month period', 'adults admitted to the intensive care unit (protocol', 'adults admitted to the ICU', 'adults receiving intensive care', 'Delirium in intensive care', 'adults cared for in the intensive care unit (ICU']",['nurse-led intervention'],"['incidence and duration of delirium', 'interest are (i) the incidence of delirium before and after the implementation of the nurse-led intervention\xa0and\xa0(ii) the number of delirium-free days during an ICU stay']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C1171177', 'cui_str': 'Adult care'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}]",4.0,0.220326,"A stepped-wedge cluster randomised controlled trial approach will be used to assess the effectiveness of the nurse-led intervention, in four adult ICUs across the South Western Sydney Local Health District (SWS-LHD), over a 12-month period.","[{'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Lynch', 'Affiliation': 'Critical Care Research in Collaboration and Evidence Translation (CCRICET), Australia; School of Nursing and Midwifery, Western Sydney University, Australia; Intensive Care Unit Liverpool Hospital, Australia.'}, {'ForeName': 'Kaye', 'Initials': 'K', 'LastName': 'Rolls', 'Affiliation': 'Critical Care Research in Collaboration and Evidence Translation (CCRICET), Australia; School of Nursing and Midwifery, Western Sydney University, Australia; Intensive Care Fairfield Hospital, Australia; School of Nursing, University of Wollongong, Australia. Electronic address: Kaye.rolls@westernsydney.edu.au.'}, {'ForeName': 'Yu Chin', 'Initials': 'YC', 'LastName': 'Hou', 'Affiliation': 'Critical Care Research in Collaboration and Evidence Translation (CCRICET), Australia; Intensive Care Unit Liverpool Hospital, Australia; Centre for Applied Nursing Research, SWSLHD, Australia.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Hedges', 'Affiliation': 'Critical Care Research in Collaboration and Evidence Translation (CCRICET), Australia; Intensive Care Bankstown Hospital, Australia; Centre for Applied Nursing Research, SWSLHD, Australia.'}, {'ForeName': 'Masar', 'Initials': 'M', 'LastName': 'Al Sayfe', 'Affiliation': 'Intensive Care Fairfield Hospital, Australia.'}, {'ForeName': 'Sharon-Ann', 'Initials': 'SA', 'LastName': 'Shunker', 'Affiliation': 'Intensive Care Unit Liverpool Hospital, Australia.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Brennan', 'Affiliation': 'Critical Care Research in Collaboration and Evidence Translation (CCRICET), Australia; Intensive Care Bankstown Hospital, Australia; Centre for Applied Nursing Research, SWSLHD, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Sanchez', 'Affiliation': 'Critical Care Research in Collaboration and Evidence Translation (CCRICET), Australia; Intensive Care Unit Campbelltown Hospital, South Western Sydney Local Health District, Australia.'}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Bogdanovski', 'Affiliation': 'Intensive Care Unit Liverpool Hospital, Australia.'}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Hunt', 'Affiliation': 'Critical Care Research in Collaboration and Evidence Translation (CCRICET), Australia; School of Nursing and Midwifery, Western Sydney University, Australia; Intensive Care Unit Liverpool Hospital, Australia.'}, {'ForeName': 'Evan', 'Initials': 'E', 'LastName': 'Alexandrou', 'Affiliation': 'Critical Care Research in Collaboration and Evidence Translation (CCRICET), Australia; School of Nursing and Midwifery, Western Sydney University, Australia; Intensive Care Unit Liverpool Hospital, Australia.'}, {'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Frost', 'Affiliation': 'Critical Care Research in Collaboration and Evidence Translation (CCRICET), Australia; School of Nursing and Midwifery, Western Sydney University, Australia; Intensive Care Unit Liverpool Hospital, Australia; Centre for Applied Nursing Research, SWSLHD, Australia.'}]",Australian critical care : official journal of the Confederation of Australian Critical Care Nurses,['10.1016/j.aucc.2019.12.003']
221,32201309,Scaling Implementation of the Serious Illness Care Program Through Coaching.,"BACKGROUND


We designed group coaching calls to reinforce communication skill acquisition and Serious Illness Care Program uptake in adult primary care.
MEASURES


Percentage of primary care physicians (PCPs) who have documented a serious illness conversation in the electronic health record (EHR) approximately three and six months after the coaching intervention. Participant feedback surveys to better understand provider attitudes toward the coaching intervention.
INTERVENTION


We offered 60-minute group coaching calls to internal medicine PCPs, previously trained in serious illness conversation skills, as part of an institutional quality incentive program. The calls addressed communication challenges common to serious illness care and instructed participants about how to document and bill for conversations.
OUTCOMES


We completed 31 coaching calls during three months, in which 170 of 228 PCPs attended in groups of two to nine participants per call (74.6% penetration rate). The percentage of PCPs who documented at least one serious illness conversation in the EHR increased from 18.4% to 41.2% six months after the intervention. Primary care internal medicine physicians found the one-hour coaching calls to be highly valuable, with 86.9% of respondents attesting they would recommend the calls to their colleagues. Content analysis of participant feedback identified the most useful coaching content elements to be self-reflection around the impact of prior conversation skills training, instruction around using the EHR to find and document advance care planning discussions, the opportunity to share individual challenges and successes with peers, and feedback/advice from communication experts in palliative care.
CONCLUSIONS/LESSONS LEARNED


Group coaching of PCPs resulted in more than a twofold increase in documented serious illness conversations.",2020,"Primary care internal medicine physicians found the one-hour coaching calls to be highly valuable, with 86.9% of respondents attesting they would recommend the calls to their colleagues.",[],[],"['percentage of PCPs', 'serious illness conversations', 'serious illness conversation in the electronic health record (EHR', 'EHR']",[],[],"[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0033131', 'cui_str': 'Primary care physician'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}]",,0.0201856,"Primary care internal medicine physicians found the one-hour coaching calls to be highly valuable, with 86.9% of respondents attesting they would recommend the calls to their colleagues.","[{'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Alexander Cole', 'Affiliation': 'Division of Palliative Care and Geriatrics, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA. Electronic address: calexandercole@mgh.harvard.edu.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Wilson', 'Affiliation': 'Division of Palliative Care and Geriatrics, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Phuong L', 'Initials': 'PL', 'LastName': 'Nguyen', 'Affiliation': 'Division of Palliative Care and Geriatrics, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Amanda M', 'Initials': 'AM', 'LastName': 'Hazeltine', 'Affiliation': 'Division of Palliative Care and Geriatrics, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Greer', 'Affiliation': 'Center for Psychiatric Oncology and Behavioral Sciences, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Juliet', 'Initials': 'J', 'LastName': 'Jacobsen', 'Affiliation': 'Division of Palliative Care and Geriatrics, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2020.03.008']
222,30724009,When basal insulin is not enough: A dose-response relationship between insulin glargine 100 units/mL and glycaemic control.,"AIMS


A post-hoc analysis to assess the impact in people with type 2 diabetes, of increasing doses of basal insulin on glycaemic measures, body weight and hypoglycaemia.
RESEARCH DESIGN AND METHODS


We included data from prospective, randomized controlled treat-to-target trials of ≥24 weeks' duration in people with type 2 diabetes, uncontrolled on metformin and sulphonylureas, and treated with insulin glargine 100 units/mL (U100), who had at least six fasting plasma glucose (FPG) measurements. The impact of insulin dose on glycated haemoglobin (HbA1c) values, FPG, hypoglycaemia incidence (<3.9 mmol/L [70 mg/dL]), and body weight was analysed. A total of 458 participants from three eligible trials were included.
RESULTS


The observed relationship between higher basal insulin doses and glycaemic control was non-linear, with increasing insulin dose leading to smaller reductions in FPG and HbA1c for doses >0.3 IU/kg/d, with a plateauing effect at 0.5 IU/kg/d. Total daily dose of insulin >0.5 IU/kg/d resulted in greater weight gain, but without higher rates of hypoglycaemia, compared with insulin doses ≤0.5 IU/kg/d.
CONCLUSIONS


This analysis indicates that basal insulin doses >0.5 IU/kg/d have diminishing additional impact on improving glycaemic measures, with the disadvantage of additional weight gain. Clinicians should consider anti-hyperglycaemic treatment intensification at doses approaching 0.5 IU/kg/d.",2019,"0.5 IU/kg/d resulted in greater weight gain, but without higher rates of hypoglycaemia, compared with insulin doses ≤0.5 IU/kg/d.
","[""≥24 weeks' duration in people with type 2 diabetes, uncontrolled on metformin and sulphonylureas, and treated with"", '458 participants from three eligible trials were included', 'people with type 2 diabetes', '100 units/mL (U100), who had at least six fasting plasma glucose (FPG) measurements']","['insulin glargine', 'insulin ']","['greater weight gain', 'rates of hypoglycaemia', 'glycaemic measures', 'glycated haemoglobin (HbA1c) values, FPG, hypoglycaemia incidence ', 'body weight']","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled (qualifier value)'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C2945590', 'cui_str': 'unit/mL'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}]","[{'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}]","[{'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}]",458.0,0.457284,"0.5 IU/kg/d resulted in greater weight gain, but without higher rates of hypoglycaemia, compared with insulin doses ≤0.5 IU/kg/d.
","[{'ForeName': 'Guillermo E', 'Initials': 'GE', 'LastName': 'Umpierrez', 'Affiliation': 'Division of Endocrinology, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Skolnik', 'Affiliation': 'Abington Family Medicine, Jefferson Health, Jenkintown, Pennsylvania.'}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Dex', 'Affiliation': 'Sanofi US, Inc., Bridgewater, New Jersey.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Traylor', 'Affiliation': 'Sanofi US, Inc., Bridgewater, New Jersey.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Chao', 'Affiliation': 'Xinyi, Inc., Bridgewater, New Jersey.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Shaefer', 'Affiliation': 'University Medical Group, Augusta, Georgia.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13653']
223,31687178,Cerebral palsy and bruxism: Effects of botulinum toxin injections-A randomized controlled trial.,"Objective


Cerebral palsy (CP) includes disturbances in muscular control caused by perinatal brain injury. Masticatory muscle involvement hampers functions such as chewing and talking. Bruxism and temporomandibular disorders are overrepresented. Neuromuscular blocks with botulinum toxin type A (BTX-A) may alleviate problems due to muscular hyperactivity. The aim was to evaluate masticatory muscle BTX-A injections in subjects with CP and bruxism.
Methods


A prospective, parallel, randomized, placebo-controlled, and double-blind trial in 12 patients with CP was performed. End points were alterations in objective and subjective oral capacities after two BTX-A or corresponding placebo injections. Matched, healthy references were also evaluated.
Results


The reference group demonstrated stronger and more efficient oral functions compared with the CP group. Subjective and objective oral capacities appeared to vary considerably between CP patients and also over time in this patient group and were poorly correlated. No significant effect of BTX-A compared with placebo on outcome variables was observed at group level, but continued treatment with BTX-A was requested by the majority of the patients.
Conclusion


The evidence is unable to support the use of BTX-A for the treatment of affected masticatory muscles in CP, but the findings are inconclusive in certain respects. Larger, more homogeneous groups of CP patients need to be evaluated in future trials.",2019,"No significant effect of BTX-A compared with placebo on outcome variables was observed at group level, but continued treatment with BTX-A was requested by the majority of the patients.
","['subjects with CP and bruxism', '12 patients with CP was performed']","['botulinum toxin injections', 'placebo', 'botulinum toxin type A (BTX-A', 'BTX-A injections']","['masticatory muscle', 'Subjective and objective oral capacities', 'objective and subjective oral capacities', 'efficient oral functions']","[{'cui': 'C0006325', 'cui_str': 'Teeth Grinding Disorder'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C1321035', 'cui_str': 'Injection of botulinum toxin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0006050', 'cui_str': 'Botulinum Toxin Type A'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C0024890', 'cui_str': 'Masticatory muscles'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0442799', 'cui_str': 'Efficient (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}]",,0.123262,"No significant effect of BTX-A compared with placebo on outcome variables was observed at group level, but continued treatment with BTX-A was requested by the majority of the patients.
","[{'ForeName': 'Birgitta Johansson', 'Initials': 'BJ', 'LastName': 'Cahlin', 'Affiliation': 'Department of Orofacial Pain and Jaw Function and Mun-H-Center, National Orofacial Resource Center for Rare Diseases, Public Dental Service Region Västra Götaland, Institute of Odontology, The Sahlgrenska Academy University of Gothenburg Gothenburg Sweden.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Lindberg', 'Affiliation': 'Department of Neuroscience and Rehabilitation, Institute of Neuroscience and Physiology, The Sahlgrenska Academy University of Gothenburg Gothenburg Sweden.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Dahlström', 'Affiliation': 'Department of Behavioral and Community Dentistry, Institute of Odontology, The Sahlgrenska Academy University of Gothenburg Gothenburg Sweden.'}]",Clinical and experimental dental research,['10.1002/cre2.207']
224,31608552,"Impact of baseline characteristics and beta-cell function on the efficacy and safety of subcutaneous once-weekly semaglutide: A patient-level, pooled analysis of the SUSTAIN 1-5 trials.","AIM


To evaluate the impact of relevant patient-level characteristics on the efficacy and safety of subcutaneous, once-weekly semaglutide in subjects with type 2 diabetes.
MATERIALS AND METHODS


Exploratory post hoc analyses of pooled SUSTAIN 1-5 (phase 3a) randomized, controlled trials examined the change from baseline in HbA1c and body weight (BW), and the proportions of subjects achieving the composite endpoint (HbA1c < 7.0% [53 mmol/mol]), without weight gain or severe/blood glucose-confirmed symptomatic hypoglycaemia at week 30 with semaglutide (0.5/1.0 mg) across clinically relevant patient subgroups: baseline HbA1c (≤7.5%, >7.5%-8.0%, >8.0%-8.5%, >8.5%-9.0% and > 9.0%), background medications, diabetes duration and pancreatic beta-cell function.
RESULTS


Mean HbA1c (% point) reductions increased from lowest to highest HbA1c subgroups (-0.9%, -1.2%,-1.5%, -1.7% and -2.3% [effect of subgroup within treatment: P = 0.247] for semaglutide 0.5 mg, and -1.1%, -1.4%, -1.9%, -2.1% and -2.7% [P = 0.045] for semaglutide 1.0 mg), with mean HbA1c ranges at week 30 of 6.3%-7.3% and 6.1%-6.9%, respectively. The corresponding BW reductions generally decreased with increasing baseline HbA1c (-4.4, -3.9, -3.9, -3.3 and -2.9 kg [P = 0.004], and -6.4, -5.9, -5.2, -4.5 and -4.8 kg [P < 0.001], respectively). HbA1c and BW reductions were consistently greater for semaglutide 1.0 mg versus 0.5 mg across background medication, diabetes duration and pancreatic beta-cell function subgroups. Adverse events with semaglutide were consistent with the glucagon-like peptide-1 receptor agonist class, with gastrointestinal events the most common.
CONCLUSIONS


Semaglutide was consistently efficacious across the continuum of diabetes care in a broad spectrum of patient subgroups with a range of clinical characteristics.",2020,"HbA 1c  and BW reductions were consistently greater for semaglutide 1.0 mg versus 0.5 mg across background medication, diabetes duration and pancreatic beta-cell function subgroups.","['subjects with T2D', '1-5 (phase 3a) randomized, controlled trials examined the change from baseline in HbA 1c  and body weight (BW), and the proportions of subjects achieving the composite endpoint (HbA 1c  <7.0% [53\u2009mmol/mol], without weight gain or severe/blood glucose-confirmed symptomatic hypoglycaemia) at week 30 with semaglutide (0.5/1.0 mg) across clinically relevant patient subgroups: baseline HbA 1c  (≤7.5, >7.5-8.0, >8.0-8.5, >8.5-9.0 and >9.0%), background medications, diabetes duration and pancreatic beta-cell function']",['subcutaneous once-weekly semaglutide'],"['corresponding BW reductions', 'Mean HbA 1c  (%-point) reductions', 'efficacy and safety', 'HbA 1c  and BW reductions']","[{'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517859', 'cui_str': 'Seven point five'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0030281', 'cui_str': 'Insulin-Secreting Cells'}, {'cui': 'C0031843', 'cui_str': 'function'}]","[{'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0558293', 'cui_str': 'Once a week (qualifier value)'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}]","[{'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.124288,"HbA 1c  and BW reductions were consistently greater for semaglutide 1.0 mg versus 0.5 mg across background medication, diabetes duration and pancreatic beta-cell function subgroups.","[{'ForeName': 'Vanita R', 'Initials': 'VR', 'LastName': 'Aroda', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Matthew S', 'Initials': 'MS', 'LastName': 'Capehorn', 'Affiliation': 'Rotherham Institute for Obesity, Clifton Medical Centre, Rotherham, UK.'}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Chaykin', 'Affiliation': 'Meridien Research, Bradenton, Florida.'}, {'ForeName': 'Juan P', 'Initials': 'JP', 'LastName': 'Frias', 'Affiliation': 'National Research Institute, Los Angeles, California.'}, {'ForeName': 'Nanna L', 'Initials': 'NL', 'LastName': 'Lausvig', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Stanislava', 'Initials': 'S', 'LastName': 'Macura', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Lüdemann', 'Affiliation': 'Diabetes-Falkensee, Diabetes-Centre and Centre for Clinical Studies, Falkensee, Germany.'}, {'ForeName': 'Sten', 'Initials': 'S', 'LastName': 'Madsbad', 'Affiliation': 'Hvidovre Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Rosenstock', 'Affiliation': 'Dallas Diabetes Research Center at Medical City, Dallas, Texas.'}, {'ForeName': 'Omur', 'Initials': 'O', 'LastName': 'Tabak', 'Affiliation': 'Istanbul Kanuni Sultan Suleyman Education and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Sayeh', 'Initials': 'S', 'LastName': 'Tadayon', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Stephen C', 'Initials': 'SC', 'LastName': 'Bain', 'Affiliation': 'Diabetes Research Unit Cymru, Swansea University Medical School, Swansea, UK.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13896']
225,31691472,Efficacy and safety of MYL-1501D versus insulin glargine in people with type 1 diabetes mellitus: Results of the INSTRIDE 3 phase 3 switch study.,"AIMS


To assess the efficacy, insulin dose, safety and immunogenicity when people with type 1 diabetes mellitus switched between MYL-1501D and reference insulin glargine (Lantus®; Sanofi-Aventis US LLC, Bridgewater, New Jersey).
MATERIALS AND METHODS


Eligible participants from INSTRIDE 1 who completed 52 weeks of reference insulin glargine treatment were randomized 1:1 to the reference sequence (n = 63; reference insulin glargine for 36 weeks) or to the treatment-switching sequence (n = 64; MYL-1501D [weeks 0-12], reference insulin glargine [weeks 12-24] and MYL-1501D [weeks 24-36]). Change in glycated haemoglobin (HbA1c) from baseline to week 36 was the primary efficacy endpoint used to demonstrate equivalence between the two treatment sequences. Secondary endpoints included: change in fasting plasma glucose (FPG), self-monitored blood glucose (SMBG) and insulin dose; immunogenicity; and adverse events, including hypoglycaemia.
RESULTS


Mean changes in HbA1c (least squares [LS] mean [SE]) from baseline to week 36 were -0.05 (0.032) and -0.06 (0.034) for the treatment-switching and reference sequences, respectively (LS mean difference 0.01 [95% CI -0.085 to 0.101]). Treatment sequences were comparable in terms of secondary endpoints, including FPG, SMBG and insulin dose, and the safety and immunogenicity profiles of the two sequences were similar.
CONCLUSIONS


Switching participants between MYL-1501D and reference insulin glargine demonstrated equivalent efficacy and similar safety and immunogenicity, showing that people taking reference insulin glargine can safely switch to MYL-1501D.",2020,"Treatment sequences were comparable in terms of secondary endpoints, including FPG, SMBG, and insulin dose, and the safety and immunogenicity profiles of the 2 sequences were similar.
","['Patients', 'Eligible patients from INSTRIDE 1 who completed 52\u2009weeks of reference', 'patients with type 1 diabetes mellitus switched between MYL-1501D and reference insulin glargine (Lantus®; Sanofi-Aventis US LLC, Bridgewater, NJ', 'With Type 1 Diabetes Mellitus']","['MYL-1501D Versus Insulin Glargine', 'insulin glargine', 'insulin glargine for 36\u2009weeks) or to the treatment-switching sequence (n\xa0=\xa064; MYL-1501D [weeks 0-12], reference insulin glargine']","['FPG, SMBG, and insulin dose, and the safety and immunogenicity profiles', 'Mean changes in HbA 1c  (least squares [LS', 'change in fasting plasma glucose (FPG), self-monitored blood glucose (SMBG), and insulin dose; immunogenicity; and adverse events, including hypoglycemia', 'glycated hemoglobin (HbA 1c  ', 'Efficacy and Safety', 'efficacy, insulin dose, safety, and immunogenicity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C0876064', 'cui_str': 'Lantus'}]","[{'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0023189', 'cui_str': 'Least Squares'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}]",,0.0907584,"Treatment sequences were comparable in terms of secondary endpoints, including FPG, SMBG, and insulin dose, and the safety and immunogenicity profiles of the 2 sequences were similar.
","[{'ForeName': 'Thomas C', 'Initials': 'TC', 'LastName': 'Blevins', 'Affiliation': 'Texas Diabetes and Endocrinology, Austin, Texas, United States.'}, {'ForeName': 'Abhijit', 'Initials': 'A', 'LastName': 'Barve', 'Affiliation': 'Mylan Inc, Canonsburg, Pennsylvania, United States.'}, {'ForeName': 'Yaron', 'Initials': 'Y', 'LastName': 'Raiter', 'Affiliation': 'Mylan EPD, Amstelveen, The Netherlands.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Aubonnet', 'Affiliation': 'Mylan EPD, Steinhausen, Switzerland.'}, {'ForeName': 'Sandeep', 'Initials': 'S', 'LastName': 'Athalye', 'Affiliation': 'Biocon Research Limited, Bangalore, India.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Sun', 'Affiliation': 'Mylan Inc, Canonsburg, Pennsylvania, United States.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Muniz', 'Affiliation': 'Mylan Inc, Canonsburg, Pennsylvania, United States.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13904']
226,31724253,Pharmacokinetic and pharmacodynamic bioequivalence of proposed biosimilar MYL-1501D with US and European insulin glargine formulations in patients with type 1 diabetes mellitus.,"AIMS


To report phase 1 bioequivalence results comparing MYL-1501D, US reference insulin glargine (US IG), and European reference insulin glargine (EU IG).
MATERIALS AND METHODS


The double-blind, randomized, three-way crossover study compared the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of MYL-1501D, US IG and EU IG. In total, 114 patients with type 1 diabetes (T1DM) received 0.4 U/kg of each study treatment under automated euglycaemic clamp conditions. Insulin metabolite M1 concentrations, insulin glargine (IG) and glucose infusion rates (GIRs) were assessed over 30 hours. Primary PK endpoints were area under the serum IG concentration-time curve from 0 to 30 hours (AUC ins.0-30h  ) and maximum serum IG concentration (C ins.max  ). Primary PD endpoints were area under the GIR-time curve from 0 to 30 hours (AUC GIR0-30h  ) and maximum GIR (GIR max  ).
RESULTS


Bioequivalence among MYL-1501D, US IG and EU IG was demonstrated for the primary PK and PD endpoints. Least squares mean ratios were close to 1, and 90% confidence intervals were within 0.80 to 1.25. The PD GIR-time profiles were nearly superimposable. There were no noticeable differences in the safety profiles of the three treatments, and no serious adverse events were reported.
CONCLUSIONS


Equivalence with regard to PK and PD characteristics was shown among MYL-1501D, US IG and EU IG in patients with T1DM, and each treatment was well tolerated and safe.",2020,"There were no noticeable differences in the safety profiles of the 3 treatments, and no serious adverse events were reported.
","['Patients With Type 1 Diabetes Mellitus', 'patients with type 1 and type 2 diabetes mellitus (T1DM and T2DM', '114 patients with T1DM received 0.4 U/kg of each study treatment under automated euglycemic clamp conditions']","['MYL-1501D, US reference IG (US IG), and European reference IG (EU IG', 'pharmacokinetics (PK) and pharmacodynamics (PD) of MYL-1501D, US IG, and EU IG', 'MYL-1501D', 'Insulin glargine (IG', 'Biosimilar MYL-1501D With US and EU Insulin Glargine Formulations']","['area under the GIR time curve from 0 to 30 hours (AUC GIR0-30h  ) and maximum GIR (GIR max  ', 'serious adverse events', 'Insulin metabolite M1 concentrations, IG, and glucose infusion rates (GIRs', 'maximum serum IG concentration (C ins.max  ', 'tolerated and safe', 'area under the serum IG concentration-time curve', 'PD GIR time profiles', 'safety profiles']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C4708785', 'cui_str': 'One hundred and fourteen'}, {'cui': 'C4517457', 'cui_str': 'Zero point four'}, {'cui': 'C1300561', 'cui_str': 'unit/kg'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C0079318', 'cui_str': 'Glucose Clamp'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C4045974', 'cui_str': 'Biosimilars'}]","[{'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",114.0,0.094151,"There were no noticeable differences in the safety profiles of the 3 treatments, and no serious adverse events were reported.
","[{'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Heise', 'Affiliation': 'Profil, Neuss, Germany.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Donnelly', 'Affiliation': 'Mylan Inc., Morgantown, West Virginia, United States.'}, {'ForeName': 'Abhijit', 'Initials': 'A', 'LastName': 'Barve', 'Affiliation': 'Mylan Inc., Canonsburg, Pennsylvania, United States.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Aubonnet', 'Affiliation': 'Mylan EPD, Steinhausen, Switzerland.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13919']
227,32305398,5-Year Outcomes After TAVR With Balloon-Expandable Versus Self-Expanding Valves: Results From the CHOICE Randomized Clinical Trial.,"OBJECTIVES


The purpose of this study was to evaluate clinical and echocardiographic outcome data of the CHOICE (Randomized Comparison of Transcatheter Heart Valves in High Risk Patients with Severe Aortic Stenosis: Medtronic CoreValve Versus Edwards SAPIEN XT) trial at 5 years.
BACKGROUND


The CHOICE trial was designed to compare device performance of a balloon-expandable (BE) transcatheter heart valve (THV) versus a self-expanding (SE) THV.
METHODS


The CHOICE trial is an investigator-initiated trial that randomized 241 high-risk patients with severe symptomatic aortic stenosis and an anatomy suitable for treatment with both BE and SE THVs to transfemoral transcatheter aortic valve replacement with either device. The primary endpoint was device success. Patients were followed up to 5 years, with assessment of clinical outcomes, and echocardiographic evaluation of valve function and THV durability.
RESULTS


After 5 years, there were no statistically significant differences between BE and SE valves in the cumulative incidence of death from any cause (53.4% vs. 47.6%; p = 0.38), death from cardiovascular causes (31.6% vs. 21.5%; p = 0.12), all strokes (17.5% vs. 16.5%; p = 0.73), and repeat hospitalization for heart failure (28.9% vs. 22.5%; p = 0.75). SE patients had larger prosthetic valve area (1.6 ± 0.5 cm 2  vs. 1.9 ± 0.5 cm 2 ; p = 0.02) with a lower mean transprosthetic gradient (12.2 ± 8.7 mm Hg vs. 6.9 ± 2.7 mm Hg; p = 0.001) at 5 years. No differences were observed in the rates of paravalvular regurgitation. Clinical valve thrombosis occurred in 7 BE patients (7.3%) and 1 SE patient (0.8%; p = 0.06), and moderate or severe structural valve deterioration in 6 BE patients (6.6%) and no SE patient (0%; p = 0.018). The rate of bioprosthetic valve failure was low and not significantly different between both groups (4.1% vs. 3.4%; p = 0.63).
CONCLUSIONS


Five-year follow-up of patients in the CHOICE trial revealed clinical outcomes after transfemoral transcatheter aortic valve replacement with early-generation BE and SE valves that were not statistically significantly different, with limited statistical power. Forward flow hemodynamics were significantly better with the SE valve. Moderate or severe structural valve deterioration was uncommon but occurred more frequently with the BE valve. (A Comparison of Transcatheter Heart Valves in High Risk Patients With Severe Aortic Stenosis: The CHOICE Trial [CHOICE]; NCT01645202).",2020,"death from cardiovascular causes (31.6% vs. 21.5%; p = 0.12), all strokes (17.5% vs. 16.5%; p = 0.73), and repeat hospitalization for heart failure (28.9% vs. 22.5%; p = 0.75).","['High Risk Patients', 'With Severe Aortic Stenosis', 'High Risk Patients with Severe Aortic Stenosis', '241 high-risk patients with severe symptomatic aortic stenosis and an anatomy suitable for treatment with both BE and SE THVs to transfemoral transcatheter aortic valve replacement with either device']","['balloon-expandable (BE) transcatheter heart valve (THV', 'Balloon-Expandable Versus Self-Expanding Valves', 'Transcatheter Heart Valves', 'TAVR']","['5-Year Outcomes', 'device success', 'moderate or severe structural valve deterioration', 'rates of paravalvular regurgitation', 'death from cardiovascular causes', 'rate of bioprosthetic valve failure', 'larger prosthetic valve area', 'echocardiographic evaluation of valve function and THV durability', 'Clinical valve thrombosis', 'Moderate or severe structural valve deterioration', 'repeat hospitalization for heart failure', 'cumulative incidence of death']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0003507', 'cui_str': 'Aortic valve stenosis'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0002808', 'cui_str': 'Anatomy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205229', 'cui_str': 'Expanding'}, {'cui': 'C2711836', 'cui_str': 'Percutaneous replacement of aortic valve using fluoroscopic guidance'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0442343', 'cui_str': 'Transcatheter approach'}, {'cui': 'C0018825', 'cui_str': 'Cardiac valve prosthesis'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205229', 'cui_str': 'Expanding'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C4285833', 'cui_str': 'Structural valve deterioration'}, {'cui': 'C0232605', 'cui_str': 'Regurgitates after swallowing'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0336548', 'cui_str': 'Prosthetic valve'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0442343', 'cui_str': 'Transcatheter approach'}, {'cui': 'C0018825', 'cui_str': 'Cardiac valve prosthesis'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",241.0,0.192749,"death from cardiovascular causes (31.6% vs. 21.5%; p = 0.12), all strokes (17.5% vs. 16.5%; p = 0.73), and repeat hospitalization for heart failure (28.9% vs. 22.5%; p = 0.75).","[{'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Abdel-Wahab', 'Affiliation': 'Heart Center Leipzig at the University of Leipzig, Leipzig, Germany. Electronic address: mohamed.abdel-wahab@medizin.uni-leipzig.de.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Landt', 'Affiliation': 'Heart Center, Segeberger Kliniken, Bad Segeberg, Germany.'}, {'ForeName': 'Franz-Josef', 'Initials': 'FJ', 'LastName': 'Neumann', 'Affiliation': 'University Heart Center Freiburg-Bad Krozingen, Bad Krozingen, Germany.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Massberg', 'Affiliation': 'Munich University Clinic, Munich, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Frerker', 'Affiliation': 'Cardiology Department, Asklepios Clinic St. Georg, Hamburg, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kurz', 'Affiliation': 'Cardiology Department, Lübeck University Hospital, Lübeck, Germany.'}, {'ForeName': 'Jatinderjit', 'Initials': 'J', 'LastName': 'Kaur', 'Affiliation': 'Heart Center, Segeberger Kliniken, Bad Segeberg, Germany.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Toelg', 'Affiliation': 'Heart Center, Segeberger Kliniken, Bad Segeberg, Germany.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Sachse', 'Affiliation': 'Heart Center, Segeberger Kliniken, Bad Segeberg, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Jochheim', 'Affiliation': 'Munich University Clinic, Munich, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Schäfer', 'Affiliation': 'Cardiology Department, Asklepios Clinic St. Georg, Hamburg, Germany.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'El-Mawardy', 'Affiliation': 'Cardiology Department, Vivantes Wenckebach Hospital, Berlin, Germany.'}, {'ForeName': 'Derek R', 'Initials': 'DR', 'LastName': 'Robinson', 'Affiliation': 'Mathematics Department, University of Sussex, Brighton, England.'}, {'ForeName': 'Gert', 'Initials': 'G', 'LastName': 'Richardt', 'Affiliation': 'Heart Center, Segeberger Kliniken, Bad Segeberg, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2019.12.026']
228,31782534,Acute caffeine intake increases muscle oxygen saturation during a maximal incremental exercise test.,"AIMS


The main mechanism behind caffeine's ergogenicity lies in its tendency to bind to adenosine receptors, although other mechanisms might be involved. The aim of this investigation was to analyse the effects of caffeine on muscle oxygen saturation during exercise of increasing intensity.
METHODS


Thirteen healthy and active individuals volunteered to participate in a randomized, double blind, placebo-controlled crossover trial. During 2 different trials, participants either ingested a placebo (cellulose) or 3 mg/kg of caffeine. After waiting for 60 min to absorb the substances, participants underwent a maximal ramp cycle ergometer test (25 W/min). Near infrared spectrometers were positioned on each leg's vastus lateralis to monitor tissue O 2  saturation. Blood lactate concentration was measured 1 min after the end of the exercise test.
RESULTS


In comparison to the placebo, the ingestion of caffeine improved the maximal wattage (258 ± 50 vs 271 ± 54 W, respectively, P < .001, effect size [ES] = 0.27; 95% confidence interval [CI] 0.14-0.35) and blood lactate concentration (11.9 ± 3.8 vs 13.7 ± 3.5 mmol/L, P = .029, ES = 0.38; 95% CI 0.14-0.75) at the end of the test. Caffeine increased muscle oxygen saturation at several exercise workloads with a main effect found in respect to the placebo (F = 6.28, P = .029; ES = 0.30 to 0.54; 95% CI 0.01-0.78). Peak pulmonary ventilation (124 ± 29 vs 129 ± 23 L/min, P = 0.035, ES = 0.25; 95% CI 0.07-0.40) and peak oxygen uptake (3.18 ± 0.70 vs 3.33 ± 0.88 L/min, P = 0.032, ES = 0.26; 95% CI 0.08-0.51) were also increased with caffeine.
CONCLUSION


Acute ingestion of 3 mg/kg of caffeine improved peak aerobic performance and increased peak pulmonary ventilation. In addition, caffeine induced changes in muscle oxygen saturation during submaximal workloads, suggesting that this mechanism might also contribute to caffeine's ergogenic effect.",2020,"Caffeine increased muscle oxygen saturation at several exercise workloads with a main effect found in respect to the placebo (F=6.28, P=0.029; effect sizes=from 0.30-to-0.54;0.01-0.78).",['Thirteen healthy and active individuals volunteered to participate'],"['maximal ramp cycle ergometer test', 'Caffeine', 'caffeine', 'placebo', 'placebo (cellulose) or 3 mg/kg of caffeine', 'Acute caffeine intake']","['blood lactate concentration', 'peak aerobic performance', 'Peak pulmonary ventilation', 'muscle oxygen saturation', 'peak pulmonary ventilation', 'maximal wattage', 'Blood lactate concentration']","[{'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0034646', 'cui_str': 'Ramp'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}]","[{'cui': 'C0005768'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0035213', 'cui_str': 'Respiratory Airflow'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}]",13.0,0.412251,"Caffeine increased muscle oxygen saturation at several exercise workloads with a main effect found in respect to the placebo (F=6.28, P=0.029; effect sizes=from 0.30-to-0.54;0.01-0.78).","[{'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Ruíz-Moreno', 'Affiliation': 'Exercise Physiology Laboratory, Camilo José Cela University, Madrid, Spain.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Lara', 'Affiliation': 'Exercise Physiology Laboratory, Camilo José Cela University, Madrid, Spain.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Brito de Souza', 'Affiliation': 'Exercise Physiology Laboratory, Camilo José Cela University, Madrid, Spain.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Gutiérrez-Hellín', 'Affiliation': 'Exercise Physiology Laboratory, Camilo José Cela University, Madrid, Spain.'}, {'ForeName': 'Blanca', 'Initials': 'B', 'LastName': 'Romero-Moraleda', 'Affiliation': 'Exercise Physiology Laboratory, Camilo José Cela University, Madrid, Spain.'}, {'ForeName': 'Ángel', 'Initials': 'Á', 'LastName': 'Cuéllar-Rayo', 'Affiliation': 'Exercise Physiology Laboratory, Camilo José Cela University, Madrid, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Del Coso', 'Affiliation': 'Centre for Sport Studies, Rey Juan Carlos University, Fuenlabrada, Spain.'}]",British journal of clinical pharmacology,['10.1111/bcp.14189']
229,31833569,"A randomised, factorial trial to reduce arterial stiffness independently of blood pressure: Proof of concept? The VaSera trial testing dietary nitrate and spironolactone.","AIMS


To test if spironolactone or dietary nitrate from beetroot juice could reduce arterial stiffness as aortic pulse wave velocity (PWVart), a potential treatment target, independently of blood pressure.
METHODS


Daily spironolactone (≤50 mg) vs doxazosin (control ≤16 mg) and 70 mL beetroot juice (Beet-It ≤11 mmol nitrate) vs nitrate-depleted juice (placebo; 0 mmol nitrate) were tested in people at risk or with type-2 diabetes using a double-blind, 6-month factorial trial. Vascular indices (baseline, 12, 24 weeks) were cardiac-ankle vascular index (CAVI), a nominally pressure-independent stiffness measure (primary outcome), PWVart secondary, central systolic pressure and augmentation. Analysis was intention-to-treat, adjusted for systolic pressure differences between trial arms.
RESULTS


Spironolactone did not reduce stiffness, with evidence for reduced CAVI on doxazosin rather than spironolactone (mean difference [95% confidence interval]; 0.25 [-0.3, 0.5] units, P = .080), firmer for PWVart (0.37 [0.01, 0.7] m/s, P = .045). There was no difference in systolic pressure reduction between spironolactone and doxazosin (0.7 [-4.8, 3.3] mmHg, P = .7). Circulating nitrate and nitrite increased on active vs placebo juice, with central systolic pressure lowered -2.6 [-4.5, - 0.8] mmHg, P = .007 more on the active juice, but did not reduce CAVI, PWVart or peripheral pressure. Change in nitrate and nitrite concentrations were 1.5-fold [1.1-2.2] and 2.2-fold [1.3, 3.6] higher on spironolactone than on doxazosin respectively; both P < .05.
CONCLUSION


Contrary to our hypothesis, in at-risk/type 2 diabetes patients, spironolactone did not reduce arterial stiffness, rather PWVart was lower on doxazosin. Dietary nitrate elevated plasma nitrite, selectively lowering central systolic pressure, observed previously for nitrite.",2020,"= .007 more on the active juice, but did not reduce CAVI, PWVart or peripheral pressure.","['people at risk or with type-2 diabetes using a double-blind, 6-month factorial trial']","['Spironolactone', 'doxazosin', 'doxazosin (control ≤16 mg) and 70 mL beetroot juice (Beet-It ≤11 mmol nitrate) vs nitrate-depleted juice (placebo', 'spironolactone']","['systolic pressure reduction', 'CAVI, PWVart or peripheral pressure', 'Vascular indices', 'Circulating nitrate and nitrite', 'Change in nitrate and nitrite concentrations', 'cardiac-ankle vascular index (CAVI), a nominally pressure-independent stiffness measure (primary outcome), PWVart secondary, central systolic pressure and augmentation', 'arterial stiffness as aortic pulse wave velocity (PWVart', 'arterial stiffness, rather PWVart', 'central systolic pressure', 'reduced CAVI']","[{'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0037982', 'cui_str': 'Spironolactone'}, {'cui': 'C0114873', 'cui_str': 'Doxazosin'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0453112', 'cui_str': 'Beetroot (substance)'}, {'cui': 'C1268568', 'cui_str': 'Juice'}, {'cui': 'C0600054', 'cui_str': 'Beets'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0028125', 'cui_str': 'Nitrates'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C4034558', 'cui_str': 'Cardio-ankle vascular index'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0028125', 'cui_str': 'Nitrates'}, {'cui': 'C0028137', 'cui_str': 'Nitrites'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0427757', 'cui_str': 'Dipstick test of nitrite concentration'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0427008', 'cui_str': 'Stiffness (finding)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1293122', 'cui_str': 'Augmentation procedure'}, {'cui': 'C0599949', 'cui_str': 'Arterial Stiffness'}, {'cui': 'C0003483', 'cui_str': 'Aorta'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}]",,0.361521,"= .007 more on the active juice, but did not reduce CAVI, PWVart or peripheral pressure.","[{'ForeName': 'Charlotte E', 'Initials': 'CE', 'LastName': 'Mills', 'Affiliation': ""Cardiovascular Medicine Group, Department of Nutritional Sciences, School of Life Course Sciences, King's College London, UK.""}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Govoni', 'Affiliation': ""Cardiovascular Medicine Group, Department of Nutritional Sciences, School of Life Course Sciences, King's College London, UK.""}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Faconti', 'Affiliation': ""Biomedical Research Centre, Clinical Research Facility, 4th Floor, North Wing, St Thomas' Hospital, Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Maria-Linda', 'Initials': 'ML', 'LastName': 'Casagrande', 'Affiliation': ""Cardiovascular Medicine Group, Department of Nutritional Sciences, School of Life Course Sciences, King's College London, UK.""}, {'ForeName': 'Steven V', 'Initials': 'SV', 'LastName': 'Morant', 'Affiliation': 'Medicines Monitoring Unit (MEMO), University of Dundee, UK.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Crickmore', 'Affiliation': ""Cardiovascular Medicine Group, Department of Nutritional Sciences, School of Life Course Sciences, King's College London, UK.""}, {'ForeName': 'Fahad', 'Initials': 'F', 'LastName': 'Iqbal', 'Affiliation': ""Cardiovascular Medicine Group, Department of Nutritional Sciences, School of Life Course Sciences, King's College London, UK.""}, {'ForeName': 'Perry', 'Initials': 'P', 'LastName': 'Maskell', 'Affiliation': 'Medicines Monitoring Unit (MEMO), University of Dundee, UK.'}, {'ForeName': 'Alisha', 'Initials': 'A', 'LastName': 'Masani', 'Affiliation': 'Medicines Monitoring Unit (MEMO), University of Dundee, UK.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Nanino', 'Affiliation': ""Cardiovascular Medicine Group, Department of Nutritional Sciences, School of Life Course Sciences, King's College London, UK.""}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Webb', 'Affiliation': ""Biomedical Research Centre, Clinical Research Facility, 4th Floor, North Wing, St Thomas' Hospital, Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'J Kennedy', 'Initials': 'JK', 'LastName': 'Cruickshank', 'Affiliation': ""Cardiovascular Medicine Group, Department of Nutritional Sciences, School of Life Course Sciences, King's College London, UK.""}]",British journal of clinical pharmacology,['10.1111/bcp.14194']
230,31628854,Single Therapeutic and Supratherapeutic Doses of Ubrogepant Do Not Affect Cardiac Repolarization in Healthy Adults: Results From a Randomized Trial.,"Ubrogepant is a novel, oral calcitonin gene-related peptide receptor antagonist currently under US Food and Drug Administration (FDA) review for the acute treatment of migraine attacks. This double-blind, four-period crossover study compared the cardiac repolarization effect of therapeutic (100 mg) and supratherapeutic (400 mg) ubrogepant doses vs. placebo in healthy adults. Moxifloxacin 400 mg was used as an open-label active control, and the primary end point was change from baseline in Fridericia-corrected QT intervals (ΔQTcF). Assay sensitivity was demonstrated via statistically significant QTcF prolongation with moxifloxacin vs. placebo. After single oral doses of ubrogepant, the least squares mean placebo-corrected ΔQTcF (ΔΔQTcF) and 90% confidence intervals (CIs) did not exceed the 10-millisecond regulatory threshold at any timepoint. The 90% CI upper bounds were 2.46 milliseconds and 2.69 milliseconds for ubrogepant 100 and 400 mg, respectively. Categorical and concentration-based analyses were consistent with the primary result, showing no significant impact of ubrogepant on cardiac repolarization.",2020,"The 90% CI upper bounds were 2.46 msec and 2.69 msec for ubrogepant 100 mg and 400 mg, respectively.","['Healthy Adults', 'healthy adults']","['therapeutic (100 mg) and supra-therapeutic (400 mg) ubrogepant doses versus placebo', 'Moxifloxacin', 'moxifloxacin', 'placebo', 'placebo-corrected ΔQTcF (ΔΔQTcF']","['Assay sensitivity', 'Fridericia-corrected QT intervals (ΔQTcF', 'cardiac repolarization', 'QTcF prolongation']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C4505936', 'cui_str': 'ubrogepant'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0536495', 'cui_str': 'moxifloxacin'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}]","[{'cui': 'C1510438', 'cui_str': 'Assay technique (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0429028', 'cui_str': 'QT interval feature'}]",,0.279038,"The 90% CI upper bounds were 2.46 msec and 2.69 msec for ubrogepant 100 mg and 400 mg, respectively.","[{'ForeName': 'Abhijeet', 'Initials': 'A', 'LastName': 'Jakate', 'Affiliation': 'Allergan plc, Madison, New Jersey, USA.'}, {'ForeName': 'Ramesh', 'Initials': 'R', 'LastName': 'Boinpally', 'Affiliation': 'Allergan plc, Madison, New Jersey, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Butler', 'Affiliation': 'Allergan plc, Madison, New Jersey, USA.'}, {'ForeName': 'Kaifeng', 'Initials': 'K', 'LastName': 'Lu', 'Affiliation': 'Allergan plc, Madison, New Jersey, USA.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'McGeeney', 'Affiliation': 'Allergan plc, Madison, New Jersey, USA.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Periclou', 'Affiliation': 'Allergan plc, Madison, New Jersey, USA.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.1696']
231,31692226,Exenatide and dapagliflozin combination improves markers of liver steatosis and fibrosis in patients with type 2 diabetes.,"AIM


To assess the efficacy of exenatide (EXE) once weekly + dapagliflozin once daily (DAPA) versus each drug alone in reducing biomarkers of fatty liver/steatosis and fibrosis in a post hoc analysis of DURATION-8, a 104-week study in 695 patients with type 2 diabetes uncontrolled by metformin monotherapy.
MATERIALS AND METHODS


We evaluated the impact of the study treatments on non-invasive markers of hepatic steatosis (fatty liver index [FLI] and non-alcoholic fatty liver disease [NAFLD] liver fat score), fibrosis (fibrosis-4 index [FIB-4]) and severe fibrosis (NAFLD fibrosis score), along with liver enzymes and insulin resistance, at weeks 28 and 52. All outcomes in this analysis were exploratory, with nominal P values reported.
RESULTS


At week 28, biomarkers of fatty liver/steatosis and fibrosis were reduced from baseline in all treatment groups. At week 28, EXE once weekly + DAPA effects for decrease in FLI were stronger than those of EXE once weekly + placebo (PLB; -2.92, 95% confidence interval [CI] -5.11, -0.73; P = 0.0092) or DAPA+PLB (-2.77 [95% CI -4.93, -0.62]; P = 0.0119), and stronger than those of EXE once weekly + PLB at week 52 (-3.23 [95% CI -5.79, -0.68]; P = 0.0134). FIB-4 showed reduction versus baseline only in the EXE once weekly + DAPA group at both week 28 (-0.06 [95% CI -0.11, -0.01]; P = 0.0135) and week 52 (-0.05 [95% CI -0.09, -0.004]; P = 0.0308).
CONCLUSIONS


The EXE once weekly + DAPA combination showed stronger effects than EXE once weekly + PLB or DAPA + PLB in ameliorating markers of hepatic steatosis and fibrosis in patients with type 2 diabetes. Prospective trials are needed to validate these findings.",2020,FIB-4 showed reduction vs. baseline in the EQW+Dapa group only at both week 28 (-0.06,"['patients with type 2 diabetes', '695 patients with type 2 diabetes uncontrolled by metformin monotherapy']","['exenatide once weekly (EQW) plus dapagliflozin (Dapa) once daily vs. EQW+placebo (Plb) and Dapa+Plb', 'EQW+Plb or Dapa+Plb', 'Exenatide and dapagliflozin combination', 'EQW+Dapa']","['liver steatosis and fibrosis', 'hepatic steatosis (fatty liver index [FLI] and non-alcoholic fatty liver disease [NAFLD] liver fat score [NLFS]), fibrosis (fibrosis-4 index [FIB-4]) and severe fibrosis (NAFLD fibrosis score [NFS', 'hepatic steatosis and fibrosis', 'biomarkers of fatty liver/steatosis and fibrosis', 'FLI']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled (qualifier value)'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0167117', 'cui_str': 'exenatide'}, {'cui': 'C0558293', 'cui_str': 'Once a week (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}]","[{'cui': 'C2711227', 'cui_str': 'Liver Steatosis'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0015695', 'cui_str': 'Fatty Liver'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0400966', 'cui_str': 'NAFLD'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4304377', 'cui_str': 'Fibrosis-4 index'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0152254', 'cui_str': 'Fatty degeneration (morphologic abnormality)'}]",695.0,0.171162,FIB-4 showed reduction vs. baseline in the EQW+Dapa group only at both week 28 (-0.06,"[{'ForeName': 'Amalia', 'Initials': 'A', 'LastName': 'Gastaldelli', 'Affiliation': 'CNR Institute of Clinical Physiology, Pisa, Italy.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Repetto', 'Affiliation': 'Global Medical CVRM, BioPharmaceuticals Medical, AstraZeneca, Gaithersburg, Maryland, United States.'}, {'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'Guja', 'Affiliation': 'Department of Diabetes, Nutrition and Metabolic Diseases, Carol Davila University of Medicine and Pharmacy, Bucharest, Romania.'}, {'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Hardy', 'Affiliation': 'Late CVRM, BioPharmaceuticals R&D, Gaithersburg, Maryland, United States.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Han', 'Affiliation': 'Pharmapace Inc., San Diego, California, United States.'}, {'ForeName': 'Serge A', 'Initials': 'SA', 'LastName': 'Jabbour', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolic Diseases, Sidney Kimmel Medical College of Thomas Jefferson University, Philadelphia, Pennsylvania, United States.'}, {'ForeName': 'Ele', 'Initials': 'E', 'LastName': 'Ferrannini', 'Affiliation': 'CNR Institute of Clinical Physiology, Pisa, Italy.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13907']
232,31692244,"Efficacy and safety of empagliflozin as add-on to insulin in Japanese patients with type 2 diabetes: A randomized, double-blind, placebo-controlled trial.","AIM


To assess the efficacy and safety of empagliflozin as add-on to insulin in Japanese patients with type 2 diabetes (T2D).
MATERIALS AND METHODS


This multicentre, double-blind, parallel-group study randomized Japanese patients with T2D insufficiently controlled with insulin (1:1:1) to empagliflozin 10 mg (n=89), empagliflozin 25 mg (n=90) or placebo (n=90) for 52 weeks. The primary endpoint was change from baseline in glycated haemoglobin (HbA1c) at 16 weeks.
RESULTS


At 16 weeks, empagliflozin 10 mg and 25 mg significantly decreased HbA1c: adjusted mean difference -0.92% (95% confidence interval [CI] -1.11, -0.73) and -1.00% (95% CI -1.18, -0.82; both P<0.0001) compared with placebo. This difference was maintained up to 52 weeks: adjusted mean difference at 52 weeks -0.90% (95% CI -1.09, -0.70) and -0.96% (95% CI -1.15, -0.77; both P<0.0001). At 52 weeks, significant improvements in fasting plasma glucose (adjusted mean difference -27.62 mg/dL [95% CI -36.15, -19.08] and -31.99 mg/dL [95% CI -40.35, -23.62]) and in body weight (-1.78 kg [95% CI -2.46, -1.10] and -1.92 kg [95% CI -2.58, -1.25]) were also seen with empagliflozin 10 mg and 25 mg compared with placebo (all P<0.0001). At 52 weeks, the frequency of adverse events (AEs) and serious AEs was similar in the three treatment groups; confirmed hypoglycaemia was reported slightly more in participants in the empagliflozin 10 mg and 25 mg groups (23.3% and 22.2% vs 14.4%). All hypoglycaemic events were mild in severity; no episodes required assistance.
CONCLUSIONS


In Japanese patients with insufficiently controlled T2D, adding empagliflozin 10 mg or 25 mg to insulin treatment was associated with clinically meaningful reductions in HbA1c at 16 weeks and was generally well tolerated.",2020,"At 52 weeks, significant improvements in fasting plasma glucose (adjusted mean difference, -27.62","['Japanese patients', 'Japanese patients with type 2 diabetes', 'Japanese patients with type 2 diabetes (T2D', 'Japanese patients with T2D insufficiently controlled with insulin (1:1:1) to']","['placebo', 'empagliflozin 25 mg (n=90) or placebo', 'empagliflozin', 'dL']","['HbA1c', 'fasting plasma glucose', 'tolerated', 'frequency of adverse events (AEs) and serious AEs', 'change in haemoglobin A1c (HbA1c', 'efficacy and safety', 'body weight', 'Efficacy and safety', 'hypoglycaemia']","[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3848929', 'cui_str': 'empagliflozin 25 MG'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}]","[{'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}]",,0.695824,"At 52 weeks, significant improvements in fasting plasma glucose (adjusted mean difference, -27.62","[{'ForeName': 'Hirohito', 'Initials': 'H', 'LastName': 'Sone', 'Affiliation': 'Department of Hematology, Endocrinology and Metabolism, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan.'}, {'ForeName': 'Tatsuroh', 'Initials': 'T', 'LastName': 'Kaneko', 'Affiliation': 'Nippon Boehringer Ingelheim Co. Ltd., Tokyo, Japan.'}, {'ForeName': 'Kosuke', 'Initials': 'K', 'LastName': 'Shiki', 'Affiliation': 'Nippon Boehringer Ingelheim Co. Ltd., Tokyo, Japan.'}, {'ForeName': 'Yoshifumi', 'Initials': 'Y', 'LastName': 'Tachibana', 'Affiliation': 'Nippon Boehringer Ingelheim Co. Ltd., Tokyo, Japan.'}, {'ForeName': 'Egon', 'Initials': 'E', 'LastName': 'Pfarr', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.'}, {'ForeName': 'Jisoo', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.'}, {'ForeName': 'Naoko', 'Initials': 'N', 'LastName': 'Tajima', 'Affiliation': 'Jikei University School of Medicine, Tokyo, Japan.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13909']
233,31696544,"A phase 1/1b study of PUR1900, an inhaled formulation of itraconazole, in healthy volunteers and asthmatics to study safety, tolerability and pharmacokinetics.","AIMS


Oral itraconazole has variable pharmacokinetics and risks of adverse events associated with high plasma exposure. An inhalation formulation of itraconazole (PUR1900) is being developed to treat allergic bronchopulmonary aspergillosis, an allergic inflammatory disease occurring in asthmatics and patients with cystic fibrosis.
METHODS


A 3-part, open-label Phase 1 study was conducted to evaluate safety, tolerability and pharmacokinetics of PUR1900. Healthy volunteers (n = 5-6/cohort) received either single (Part 1) or multiple (Part 2) ascending doses of PUR1900 for up to 14 days. In Part 3 stable, adult asthmatics received a single dose of 20 mg PUR1900 or 200 mg of oral Sporanox (itraconazole oral solution) in a 2-period randomized cross-over design. Itraconazole plasma and sputum concentrations were evaluated.
RESULTS


None of the adverse events considered as at least possibly related to study treatment were moderate or severe, and none were classed as serious. The most common was the infrequent occurrence of mild cough. Itraconazole plasma exposure increased with increasing doses of PUR1900. After 14 days, PUR1900 resulted in plasma exposure (area under the concentration-time curve up to 24 h) 106- to 400-fold lower across doses tested (10-35 mg) than steady-state exposure reported for oral Sporanox 200 mg. In asthmatics, PUR1900 geometric mean maximum sputum concentrations were 70-fold higher and geometric mean plasma concentrations were 66-fold lower than with oral Sporanox.
CONCLUSION


PUR1900 was safe and well-tolerated under the study conditions. Compared to oral dosing, PUR1900 achieved higher lung and lower plasma exposure. The pharmacokinetic profile of PUR1900 suggests the potential to improve upon the efficacy and safety profile observed with oral itraconazole.",2020,"An inhalation formulation of itraconazole (PUR1900) is being developed to treat Allergic Bronchopulmonary Aspergillosis (ABPA), an allergic inflammatory disease occurring in asthmatics and patients with cystic fibrosis.
","['asthmatics and patients with cystic fibrosis', 'Healthy volunteers (n=5-6/cohort) received either', 'healthy volunteers and asthmatics to study']","['PUR1900 or 200mg of oral Sporanox (itraconazole oral solution', 'single (Part 1) or multiple (Part 2) ascending doses of PUR1900', 'itraconazole', 'itraconazole (PUR1900', 'Itraconazole', 'PUR1900']","['safe and well-tolerated', 'Itraconazole plasma and sputum concentrations', 'efficacy and safety profile', 'PUR1900 geometric mean C max  sputum concentrations', 'mild cough', 'geometric mean plasma AUC 0-t  concentrations', 'safety, tolerability and pharmacokinetics', 'higher lung and lower plasma exposure']","[{'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0010674', 'cui_str': 'Mucoviscidosis'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0699614', 'cui_str': 'Sporanox'}, {'cui': 'C1263371', 'cui_str': 'Itraconazole Oral Solution [Sporanox]'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0205385', 'cui_str': 'Ascending (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0064113', 'cui_str': 'Itraconazole'}]","[{'cui': 'C0064113', 'cui_str': 'Itraconazole'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}]",,0.0270841,"An inhalation formulation of itraconazole (PUR1900) is being developed to treat Allergic Bronchopulmonary Aspergillosis (ABPA), an allergic inflammatory disease occurring in asthmatics and patients with cystic fibrosis.
","[{'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Hava', 'Affiliation': 'Pulmatrix Inc, Lexington, MA, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Tan', 'Affiliation': 'Lisa Tan Pharma Consulting, Kingston, Cambridge, UK.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Johnson', 'Affiliation': 'JPharma Solutions, Bulach, Switzerland.'}, {'ForeName': 'Aidan K', 'Initials': 'AK', 'LastName': 'Curran', 'Affiliation': 'Pulmatrix Inc, Lexington, MA, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Perry', 'Affiliation': 'Pulmatrix Inc, Lexington, MA, USA.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Kramer', 'Affiliation': 'Pulmatrix Inc, Lexington, MA, USA.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Kane', 'Affiliation': 'Pulmatrix Inc, Lexington, MA, USA.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Bedwell', 'Affiliation': 'Way Hill, Minister, Kent, UK.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Layton', 'Affiliation': 'ParamStat Limited, Canterbury, Kent, UK.'}, {'ForeName': 'Clarie', 'Initials': 'C', 'LastName': 'Swann', 'Affiliation': 'Quotient Clinical, Nottingham, UK.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Henderson', 'Affiliation': 'Quotient Clinical, Nottingham, UK.'}, {'ForeName': 'Naimat', 'Initials': 'N', 'LastName': 'Khan', 'Affiliation': 'Medicines Evaluation Unit, The Langley Building, Wythenshawe Hospital, Wythenshawe, UK, England.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Connor', 'Affiliation': 'Medicines Evaluation Unit, The Langley Building, Wythenshawe Hospital, Wythenshawe, UK, England.'}, {'ForeName': 'Litza', 'Initials': 'L', 'LastName': 'McKenzie', 'Affiliation': 'Quotient Clinical, Nottingham, UK.'}, {'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Singh', 'Affiliation': 'Medicines Evaluation Unit, The Langley Building, Wythenshawe Hospital, Wythenshawe, UK, England.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Roach', 'Affiliation': 'Pulmatrix Inc, Lexington, MA, USA.'}]",British journal of clinical pharmacology,['10.1111/bcp.14166']
234,32305477,"Lower Ischemic Heart Disease Diagnostic Costs With Treadmill Stress CMR Versus SPECT: A Multicenter, Randomized Trial.",,2020,,[],['Treadmill Stress CMR vs. SPECT'],[],[],"[{'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0006802', 'cui_str': 'Cameroon'}, {'cui': 'C0040399', 'cui_str': 'Single photon emission computerized tomography'}]",[],,0.0703892,,"[{'ForeName': 'Subha V', 'Initials': 'SV', 'LastName': 'Raman', 'Affiliation': ''}, {'ForeName': 'Rory', 'Initials': 'R', 'LastName': 'Hachamovitch', 'Affiliation': ''}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Scandling', 'Affiliation': ''}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Mazur', 'Affiliation': ''}, {'ForeName': 'Raymond Y', 'Initials': 'RY', 'LastName': 'Kwong', 'Affiliation': ''}, {'ForeName': 'Timothy C', 'Initials': 'TC', 'LastName': 'Wong', 'Affiliation': ''}, {'ForeName': 'Erik B', 'Initials': 'EB', 'LastName': 'Schelbert', 'Affiliation': ''}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Moore', 'Affiliation': ''}, {'ForeName': 'Vien', 'Initials': 'V', 'LastName': 'Truong', 'Affiliation': ''}, {'ForeName': 'Orlando P', 'Initials': 'OP', 'LastName': 'Simonetti', 'Affiliation': ''}]",JACC. Cardiovascular imaging,['10.1016/j.jcmg.2020.02.020']
235,31747468,Does green tea extract enhance the anti-inflammatory effects of exercise on fat loss?,"AIMS


Green tea extract (GTE) can exert antiobesity and anti-inflammatory effects. Our study determined whether the benefits of GTE are summative with exercise-induced changes in anthropometric indices, and the levels of inflammatory cytokines, adiponectin and irisin in inactive overweight women.
METHODS


Thirty overweight female participants were randomized to 3 groups: endurance training + placebo (ET + P); endurance training + GTE (ET + GTE); and Control (no exercise) + placebo (Control, n = 10). The exercise intervention consisted of an 8-week endurance-training programme of 3 sessions per week (aerobics, aerobic circuit training, and fast walking or jogging at a moderate intensity of 40-59% of the heart rate reserve). The dose of GTE used was 500 mg/day in the form of a green tea capsule.
RESULTS


Body weight, body mass index, waist to hip ratio and body fat percentage were decreased in both ET + P and ET + GTE interventions (P < .001 for both interventions). The reduction of anthropometric values in the ET + GTE group was significantly higher than ET + P interventions (P < .001). Both exercise interventions also significantly (P < .001) increased adiponectin (ET + GTE = 5.28 mg/mL [95% confidence interval {CI}, 4.48 to 6.08] and ET + P = 3.34 mg/mL [95% CI, 2.76 to 3.92]) and decreased high-sensitivity C-reactive protein (hs-CRP; ET + GTE = -0.95 mg/L [95% CI, -1.15 to -0.75] and ET + P = -0.35 mg/L [95% CI, -0.46 to -0.24]). Changes in adiponectin and hs-CRP were greater (P < .05) in ET + GTE compared to ET + P. There were no significant differences in irisin, interleukin-6 or tumour necrosis factor-α between the 3 groups (P > .05).
CONCLUSIONS


GTE improves exercise-induced body composition by further decreasing exercise-induced changes in weight, body mass index, waist to hip ratio and body fat percentage. The combination of GTE and exercise also produced greater changes in anti-inflammatory (increases in adiponectin) and metabolic (decreases in hs-CRP) markers than exercise alone.",2020,"Changes in adiponectin and hs-CRP were greater (P< 0.05) in ET+GTE compared to ET+P. There were no significant differences in irisin, IL-6, and TNF-α between the three groups (P>0.05).
","['inactive overweight women', 'Thirty overweight female participants']","['GTE', 'Green tea extract (GTE', 'exercise intervention consisted of an eight-week endurance-training program of three sessions per week [aerobics, aerobic circuit training, and fast walking or jogging', 'endurance training + placebo (ET+P); endurance training + GTE (ET +GTE); and Control (no exercise) + placebo']","['irisin, IL-6, and TNF-α', 'Fat Loss', 'weight, BMI, WHR, and BFP', 'Body weight, body mass index (BMI), waist to hip ratio (WHR), and body fat percentage (BFP', 'adiponectin) and metabolic', 'reduction of anthropometric values', 'adiponectin', 'Changes in adiponectin and hs-CRP']","[{'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C1704263', 'cui_str': 'Green Tea Extract'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C2712423', 'cui_str': 'Circuit Training'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0022400', 'cui_str': 'Jogging'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0045933', 'cui_str': 'BFP'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205682', 'cui_str': 'Waist-Hip Ratio'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",30.0,0.043408,"Changes in adiponectin and hs-CRP were greater (P< 0.05) in ET+GTE compared to ET+P. There were no significant differences in irisin, IL-6, and TNF-α between the three groups (P>0.05).
","[{'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Bagheri', 'Affiliation': 'Department of Exercise Physiology, University of Isfahan, Isfahan, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Rashidlamir', 'Affiliation': 'Department of Exercise Physiology, Ferdowsi University of Mashhad, Mashhad, Iran.'}, {'ForeName': 'Damoon', 'Initials': 'D', 'LastName': 'Ashtary-Larky', 'Affiliation': 'Nutrition and Metabolic Diseases Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Alexei', 'Initials': 'A', 'LastName': 'Wong', 'Affiliation': 'Department of Health and Human Performance, Marymount University, Arlington, VA, USA.'}, {'ForeName': 'Meysam', 'Initials': 'M', 'LastName': 'Alipour', 'Affiliation': 'Alimentary Tract Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Mohamad S', 'Initials': 'MS', 'LastName': 'Motevalli', 'Affiliation': 'Department of Exercise Physiology, Ferdowsi University of Mashhad, Mashhad, Iran.'}, {'ForeName': 'Amel', 'Initials': 'A', 'LastName': 'Chebbi', 'Affiliation': 'Faculty of Medicine of Tunis, University of Tunis, Tunis, Tunisia.'}, {'ForeName': 'Ismail', 'Initials': 'I', 'LastName': 'Laher', 'Affiliation': 'Department of Pharmacology and Therapeutics, Faculty of Medicine, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Hassane', 'Initials': 'H', 'LastName': 'Zouhal', 'Affiliation': 'Univ Rennes, M2S (Laboratoire Mouvement, Sport, Santé), Rennes, France.'}]",British journal of clinical pharmacology,['10.1111/bcp.14176']
236,31749275,Liraglutide for perioperative management of hyperglycaemia in cardiac surgery patients: a multicentre randomized superiority trial.,"AIMS


Most cardiac surgery patients, with or without diabetes, develop perioperative hyperglycaemia, for which intravenous insulin is the only therapeutic option. This is labour-intensive and carries a risk of hypoglycaemia. We hypothesized that preoperative administration of the glucagon-like peptide-1 receptor agonist liraglutide reduces the number of patients requiring insulin for glycaemic control during cardiac surgery.
MATERIALS AND METHODS


In this randomized, blinded, placebo-controlled, parallel-group, balanced (1:1), multicentre randomized, superiority trial, adult patients undergoing cardiac surgery in four Dutch tertiary hospitals were randomized to receive 0.6 mg subcutaneous liraglutide on the evening before surgery and 1.2 mg after induction of anaesthesia or matching placebo. Blood glucose was measured hourly and controlled using an insulin-bolus algorithm. The primary outcome was insulin administration for blood glucose >8.0 mmol/L in the operating theatre. Research pharmacists used centralized, stratified, variable-block, randomization software. Patients, care providers and study personnel were blinded to treatment allocation.
RESULTS


Between June 2017 and August 2018, 278 patients were randomized to liraglutide (139) or placebo (139). All patients receiving at least one study drug injection were included in the intention-to-treat analyses (129 in the liraglutide group, 132 in the placebo group). In the liraglutide group, 55 (43%) patients required additional insulin compared with 80 (61%) in the placebo group and absolute difference 18% (95% confidence interval 5.9-30.0, P = 0.003). Dose and number of insulin injections and mean blood glucose were all significantly lower in the liraglutide group. We observed no difference in the incidence of hypoglycaemia, nausea and vomiting, mortality or postoperative complications.
CONCLUSIONS


Preoperative liraglutide, compared with placebo, reduces insulin requirements while improving perioperative glycaemic control during cardiac surgery.",2020,"We observed no difference in the incidence of hypoglycaemia, nausea and vomiting, mortality, or postoperative complications.
","['cardiac surgery patients', 'All patients receiving at least one study drug injection were included in the intention-to-treat analyses (129 in the liraglutide group, 132 in the placebo group', 'cardiac surgery patients, with or without diabetes', 'Between June 2017 and August 2018, 278 patients', 'adult patients undergoing cardiac surgery in four Dutch tertiary hospitals']","['glucagon-like peptide-1 receptor agonist liraglutide', 'Liraglutide', 'placebo', 'anaesthesia or matching placebo', 'liraglutide', '0·6 mg subcutaneous liraglutide']","['insulin requirements', 'Blood glucose', 'additional insulin', 'incidence of hypoglycaemia, nausea and vomiting, mortality, or postoperative complications', 'Dose and number of insulin injections and mean blood glucose', 'insulin administration for blood glucose above 8·0\u2009mmol/L in the operating theatre']","[{'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0013331', 'cui_str': 'Dutch (ethnic group)'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}]","[{'cui': 'C0378073', 'cui_str': 'GLP-1 Receptor'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1522438', 'cui_str': 'SC use'}]","[{'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0586328', 'cui_str': 'Insulin injection'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C1532563', 'cui_str': 'umol/mL'}, {'cui': 'C0029064', 'cui_str': 'Operating Room'}]",278.0,0.746046,"We observed no difference in the incidence of hypoglycaemia, nausea and vomiting, mortality, or postoperative complications.
","[{'ForeName': 'Abraham H', 'Initials': 'AH', 'LastName': 'Hulst', 'Affiliation': 'Department of Anesthesiology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Maarten J', 'Initials': 'MJ', 'LastName': 'Visscher', 'Affiliation': 'Department of Anesthesiology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Marc B', 'Initials': 'MB', 'LastName': 'Godfried', 'Affiliation': 'Department of Anesthesiology, OLVG, Amsterdam, The Netherlands.'}, {'ForeName': 'Bram', 'Initials': 'B', 'LastName': 'Thiel', 'Affiliation': 'Department of Anesthesiology, OLVG, Amsterdam, The Netherlands.'}, {'ForeName': 'Bastiaan M', 'Initials': 'BM', 'LastName': 'Gerritse', 'Affiliation': 'Department of Anesthesiology, Amphia Hospital, Breda, The Netherlands.'}, {'ForeName': 'Thierry V', 'Initials': 'TV', 'LastName': 'Scohy', 'Affiliation': 'Department of Anesthesiology, Amphia Hospital, Breda, The Netherlands.'}, {'ForeName': 'R Arthur', 'Initials': 'RA', 'LastName': 'Bouwman', 'Affiliation': 'Department of Anesthesiology, Catharina Hospitals, Eindhoven, The Netherlands.'}, {'ForeName': 'Mark G A', 'Initials': 'MGA', 'LastName': 'Willemsen', 'Affiliation': 'Department of Anesthesiology, Catharina Hospitals, Eindhoven, The Netherlands.'}, {'ForeName': 'Markus W', 'Initials': 'MW', 'LastName': 'Hollmann', 'Affiliation': 'Department of Anesthesiology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Benedikt', 'Initials': 'B', 'LastName': 'Preckel', 'Affiliation': 'Department of Anesthesiology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'J Hans', 'Initials': 'JH', 'LastName': 'DeVries', 'Affiliation': 'Department of Endocrinology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Hermanides', 'Affiliation': 'Department of Anesthesiology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Diabetes, obesity & metabolism",['10.1111/dom.13927']
237,31912513,"Safety, tolerability, pharmacokinetics and pharmacodynamics of parenterally administered dutogliptin: A prospective dose-escalating trial.","AIMS


Animal studies suggest that inhibition of dipeptidyl peptidase 4 (DPP-IV) may improve heart function and survival after myocardial infarction by increasing cardiac myocytes' regenerative capacity. Parenterally administered dutogliptin may provide continuous strong DPP-IV inhibition to translate these results into humans. This trial investigated the safety and tolerability, as well as pharmacokinetics and pharmacodynamics, of parenterally administered dutogliptin after single and repeated doses.
METHODS


In an open-label trial, volunteers received dutogliptin at increasing doses of 30-120 mg subcutaneously or 30 mg intravenously in the single-dose cohorts. Subjects in the multiple-dose cohort received 60, 90 or 120 mg dutogliptin subcutaneously once daily on 7 consecutive days.
RESULTS


Forty healthy males were included in the trial. No related serious adverse events occurred. Mild local injection site reactions with no requirement for intervention comprised 147 of 153 (96%) related adverse events. Subcutaneous bioavailability was approximately 100%. Multiple injections at daily intervals did not lead to the accumulation of the study drug. The accumulation ratios based on AUC 0-24h  range from 0.90 to 1.03, supporting this argument. All subjects receiving ≥60 mg dutogliptin yielded a maximum DPP-IV inhibition >90%. The duration of DPP-IV inhibition over time increased in a dose-dependent manner and was highest in the 120-mg multiple-dosing cohort with a maximum AUEC 0-24h  of 342 h % (standard deviation: 73), translating into 86% DPP-IV inhibition 24 hours after dosing.
CONCLUSION


Parenteral injection of dutogliptin was safe and subcutaneous bioavailability is excellent. DPP-IV inhibition increased dose dependently to >86% over 24 hours after multiple doses of 120 mg dutogliptin.",2020,DPP-IV inhibition increased dose dependently to >86% over 24 hours after multiple doses of 120mg dutogliptin.,['Forty healthy males'],"['dutogliptin', 'dipeptidyl peptidase IV (DPP-IV', 'parenterally administered dutogliptin']","['heart function and survival', 'Subcutaneous bioavailability', 'accumulation ratios', 'Mild local injection site reactions', 'serious adverse events', 'DPP-IV inhibition', 'duration of DPP-IV inhibition over time', 'safety and tolerability', 'adverse events', 'Safety, tolerability, pharmacokinetics and pharmacodynamics']","[{'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C2828326', 'cui_str': 'dutogliptin'}, {'cui': 'C0081937', 'cui_str': 'Dipeptidyl-Peptidase IV'}, {'cui': 'C0058353', 'cui_str': 'DPPS'}, {'cui': 'C1621583', 'cui_str': 'Administer'}]","[{'cui': 'C4521692', 'cui_str': 'Cardiac physiological function (observable entity)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0005508', 'cui_str': 'Bioavailability'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0151735', 'cui_str': 'Injection Site Adverse Event'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0058353', 'cui_str': 'DPPS'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}]",40.0,0.0498745,DPP-IV inhibition increased dose dependently to >86% over 24 hours after multiple doses of 120mg dutogliptin.,"[{'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Buchtele', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Austria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schwameis', 'Affiliation': 'Department of Emergency Medicine, Medical University of Vienna, Austria.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Schoergenhofer', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Austria.'}, {'ForeName': 'Ulla', 'Initials': 'U', 'LastName': 'Derhaschnig', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Austria.'}, {'ForeName': 'Christa', 'Initials': 'C', 'LastName': 'Firbas', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Austria.'}, {'ForeName': 'Rudolf', 'Initials': 'R', 'LastName': 'Karch', 'Affiliation': 'Section of Biosimulation and Bioinformatics, Center for Medical Statistics, Informatics and Intelligent Systems (CeMSIIS), Medical University of Vienna, Austria.'}, {'ForeName': 'Darrell', 'Initials': 'D', 'LastName': 'Nix', 'Affiliation': 'RECARDIO Inc., San Francisco, CA, USA.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Schenk', 'Affiliation': 'RECARDIO Inc., San Francisco, CA, USA.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Jilma', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Austria.'}]",British journal of clinical pharmacology,['10.1111/bcp.14208']
238,31646727,Assessing patient PREFERence between the dulaglutide pen and the semaglutide pen: A crossover study (PREFER).,"AIM


When selecting treatments for type 2 diabetes (T2D), it is important to consider not only efficacy and safety, but also other treatment attributes that have an impact on patient preference. The objective of this study was to examine preference between injection devices used for two weekly GLP-1 receptor agonists.
MATERIALS AND METHODS


The PREFER study was an open-label, multicentre, randomized, crossover study assessing patient preference for dulaglutide and semaglutide injection devices among injection-naïve patients receiving oral medication for type 2 diabetes. After being trained to use each device, participants performed all steps of injection preparation and administered mock injections into an injection pad. Time-to-train (TTT) for each device was assessed in a subset.
RESULTS


There were 310 evaluable participants (48.4% female; mean age, 60.0 years; 78 participants in the TTT subgroup). More participants preferred the dulaglutide device than the semaglutide device (84.2% vs. 12.3%; P < 0.0001). More participants perceived the dulaglutide device to have greater ease of use (86.8% vs. 6.8%; P < 0.0001). After preparing and using the devices, more participants were willing to use the dulaglutide device (93.5%) than the semaglutide device (45.8%). Training participants to use the dulaglutide device required less time than the semaglutide device (3.38 vs. 8.14 minutes; P < 0.0001).
CONCLUSIONS


Participants with type 2 diabetes preferred the dulaglutide injection device to the semaglutide injection device. If patients prefer a device, they may be more willing to use the medication, which could result in better health outcomes. Furthermore, a shorter training time for injection devices may be helpful in busy clinical practice settings.",2020,More participants also perceived the dulaglutide device to have greater ease-of-use (86.8% vs. 6.8%; p<0.0001).,['310 evaluable participants (48.4% female; mean age\xa0=\xa060.0; 78 participants in the TTT subgroup'],['dulaglutide and semaglutide injection devices among injection-naïve patients receiving oral medication for T2D'],['Time-to-train (TTT'],"[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C3179549', 'cui_str': 'dulaglutide'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C0794888', 'cui_str': 'Injection device (physical object)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}]",78.0,0.0635793,More participants also perceived the dulaglutide device to have greater ease-of-use (86.8% vs. 6.8%; p<0.0001).,"[{'ForeName': 'Louis S', 'Initials': 'LS', 'LastName': 'Matza', 'Affiliation': 'Evidera, Bethesda, Maryland, United States.'}, {'ForeName': 'Kristina S', 'Initials': 'KS', 'LastName': 'Boye', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, United States.'}, {'ForeName': 'Katie D', 'Initials': 'KD', 'LastName': 'Stewart', 'Affiliation': 'Evidera, Bethesda, Maryland, United States.'}, {'ForeName': 'Karin S', 'Initials': 'KS', 'LastName': 'Coyne', 'Affiliation': 'Evidera, Bethesda, Maryland, United States.'}, {'ForeName': 'Paula K', 'Initials': 'PK', 'LastName': 'Wullenweber', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, United States.'}, {'ForeName': 'Katelyn N', 'Initials': 'KN', 'LastName': 'Cutts', 'Affiliation': 'Evidera, Bethesda, Maryland, United States.'}, {'ForeName': 'Jessica B', 'Initials': 'JB', 'LastName': 'Jordan', 'Affiliation': 'Evidera, Bethesda, Maryland, United States.'}, {'ForeName': 'Qianqian', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, United States.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Yu', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, United States.'}, {'ForeName': 'Brooke M', 'Initials': 'BM', 'LastName': 'Currie', 'Affiliation': 'Evidera, Bethesda, Maryland, United States.'}, {'ForeName': 'Karen G', 'Initials': 'KG', 'LastName': 'Malley', 'Affiliation': 'Evidera, Bethesda, Maryland, United States.'}, {'ForeName': 'K Jack', 'Initials': 'KJ', 'LastName': 'Ishak', 'Affiliation': 'Evidera, Bethesda, Maryland, United States.'}, {'ForeName': 'Ryan T', 'Initials': 'RT', 'LastName': 'Hietpas', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, United States.'}, {'ForeName': 'Luis-Emilio', 'Initials': 'LE', 'LastName': 'García-Pérez', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, United States.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13902']
239,31742881,The effects of dapagliflozin on cardio-renal risk factors in patients with type 2 diabetes with or without renin-angiotensin system inhibitor treatment: a post hoc analysis.,"AIMS


Renin-angiotensin system inhibitors (RASi) are the most effective treatments for diabetic kidney disease but significant residual renal risk remains, possibly because of other mechanisms of kidney disease progression unrelated to RAS that may be present. Sodium-glucose co-transporter-2 inhibitors reduce albuminuria and may complement RASi by offering additional renal protection. This post hoc analysis investigated the effects of dapagliflozin on cardio-renal risk factors in patients with type 2 diabetes (T2D) with increased albuminuria treated with or without RASi at baseline.
MATERIALS AND METHODS


We evaluated the effects of dapagliflozin 10 mg/day over 12-24 weeks across 13 placebo-controlled studies in patients with T2D with a urinary albumin-to-creatinine ratio (UACR) ≥30 mg/g at baseline. Patients were divided into two subgroups based on treatment with or without RASi at baseline.
RESULTS


Compared with patients with RASi at baseline (n = 957), patients without RASi (n = 302) were younger, had a shorter duration of diabetes (7 vs. 12 years), higher estimated glomerular filtration rate (eGFR) and lower UACR, serum uric acid (sUA), body weight and systolic blood pressure. Placebo-adjusted treatment effects of dapagliflozin on UACR, eGFR, glycated haemoglobin and haematocrit over 24 weeks were similar across groups. Mean reductions in body weight and sUA were more distinct in patients without RASi treatment at baseline.
CONCLUSIONS


Treatment with dapagliflozin over 24 weeks provides similar clinically relevant improvements in metabolic and haemodynamic parameters, and similar reductions in UACR, in patients with T2D with elevated albuminuria treated with or without RASi at baseline.",2020,"CONCLUSIONS


Treatment with dapagliflozin over 24 weeks provides similar clinically relevant improvements in metabolic and haemodynamic parameters, and similar reductions in UACR, in patients with T2D with elevated albuminuria treated with or without RASi at baseline.","['patients with T2D with elevated albuminuria treated with or without RASi at baseline', 'patients with type 2 diabetes with or without renin-angiotensin inhibitor treatment', 'patients with T2D with urinary albumin-to-creatinine ratio (UACR) ≥30 mg/g at baseline', 'patients with type 2 diabetes (T2D) with increased albuminuria treated with or without RASi at baseline']","['dapagliflozin', 'Placebo', 'Renin-angiotensin system inhibitors (RASi', 'Sodium-glucose co-transporter-2 inhibitors']","['UACR, eGFR, HbA 1c  , and haematocrit', 'cardio-renal risk factors', 'body weight and sUA', 'shorter duration of diabetes', 'metabolic and haemodynamic parameters', 'cardiac/renal risk factors', 'higher eGFR, and lower UACR, serum uric acid (sUA), body weight, and systolic blood pressure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0035094', 'cui_str': 'Angiotensinogenase'}, {'cui': 'C0003018', 'cui_str': 'Angiotensins'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1300563', 'cui_str': 'ug/mg'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0035096'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C4301634', 'cui_str': 'Sodium-glucose co-transporter 2 (SGLT2) inhibitors'}]","[{'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0518014', 'cui_str': 'Hematocrit - finding'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0439593', 'cui_str': 'Short duration (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0455272', 'cui_str': 'Serum uric acid measurement'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}]",957.0,0.0525541,"CONCLUSIONS


Treatment with dapagliflozin over 24 weeks provides similar clinically relevant improvements in metabolic and haemodynamic parameters, and similar reductions in UACR, in patients with T2D with elevated albuminuria treated with or without RASi at baseline.","[{'ForeName': 'Rosalie A', 'Initials': 'RA', 'LastName': 'Scholtes', 'Affiliation': 'Diabetes Centre, Department of Internal Medicine, Amsterdam University Medical Centres, location VUmc, Amsterdam, The Netherlands.'}, {'ForeName': 'Daniël H', 'Initials': 'DH', 'LastName': 'van Raalte', 'Affiliation': 'Diabetes Centre, Department of Internal Medicine, Amsterdam University Medical Centres, location VUmc, Amsterdam, The Netherlands.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Correa-Rotter', 'Affiliation': 'Nephrology and Mineral Metabolism, National Medical Science and Nutrition Institute Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'Toto', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas, Texas, United States.'}, {'ForeName': 'Hiddo J L', 'Initials': 'HJL', 'LastName': 'Heerspink', 'Affiliation': 'Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Cain', 'Affiliation': 'Bogier Clinical and IT Solutions Inc., Raleigh, North Carolina, United States.'}, {'ForeName': 'C David', 'Initials': 'CD', 'LastName': 'Sjöström', 'Affiliation': 'AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Sartipy', 'Affiliation': 'AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Bergur V', 'Initials': 'BV', 'LastName': 'Stefánsson', 'Affiliation': 'AstraZeneca, Gothenburg, Sweden.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13923']
240,31742898,"Efficacy and safety of dapagliflozin in Japanese patients with inadequately controlled type 1 diabetes (DEPICT-5): 52-week results from a randomized, open-label, phase III clinical trial.","AIMS


To investigate the safety and tolerability of 5 and 10 mg dapagliflozin added to insulin therapy over 52 weeks in Japanese patients with inadequately controlled type 1 diabetes mellitus (T1DM).
MATERIALS AND METHODS


This randomized, open-label, parallel-group, multicentre phase III clinical trial was conducted from October 26, 2015 to June 15, 2017. The primary endpoint was the occurrence of adverse events such as hypoglycaemia and diabetic ketoacidosis. Secondary endpoints included changes in glycaemic parameters, total daily insulin dosage and body weight over time. The efficacy of dapagliflozin in patients stratified by body mass index (BMI) <25.0 and ≥25.0 kg/m 2  was evaluated in a subgroup analysis.
RESULTS


In total, 151 patients received 5 mg (n = 76) or 10 mg (n = 75) dapagliflozin once daily for 52 weeks. Adverse events were observed in 88.2% and 73.3% of patients in the 5 and 10 mg dapagliflozin groups, respectively. Severe hypoglycaemia was reported in 2.6% (n = 2) and 6.7% (n = 5) of patients, and diabetic ketoacidosis in 2.6% (n = 2) and 1.3% (n = 1) of patients in the 5 and 10 mg dapagliflozin groups, respectively. The adjusted mean (95% confidence interval) changes in glycated haemoglobin at week 52 were -0.33% (-0.50, -0.15) and -0.36% (-0.53, -0.18) in the 5 and 10 mg dapagliflozin groups, respectively. There were no differences in efficacy parameters when stratified by BMI.
CONCLUSIONS


This study demonstrated the long-term safety and tolerability of dapagliflozin added to insulin therapy in Japanese patients with inadequately controlled T1DM.",2020,"The adjusted mean (95% confidence interval) changes in HbA1c at Week 52 were -0.33% (-0.50, -0.15) and -0.36% (-0.53, -0.18) in the 5 and 10 mg dapagliflozin groups, respectively.","['Japanese patients with inadequately controlled type 1 diabetes mellitus (T1DM', 'Japanese patients with inadequately controlled T1DM', 'Japanese patients with inadequately controlled type 1 diabetes (DEPICT-5', 'patients stratified by body mass index (BMI) <25.0 and ≥25.0 kg/m 2  was evaluated in a subgroup analysis', '26 October 2015 to 15 June 2017']","['dapagliflozin', 'dapagliflozin added to insulin therapy', 'insulin therapy']","['changes in glycemic parameters, total daily insulin dosage, and body weight over time', 'occurrence of adverse events such as hypoglycemia and diabetic ketoacidosis', 'efficacy parameters', 'Adverse events', 'Severe hypoglycemia', 'Efficacy and safety', 'diabetic ketoacidosis', 'safety and tolerability']","[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0011854', 'cui_str': 'Diabetes Mellitus, Type 1'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0178602', 'cui_str': 'Dosages (qualifier value)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0011880', 'cui_str': 'Ketosis, Diabetic'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",151.0,0.0690176,"The adjusted mean (95% confidence interval) changes in HbA1c at Week 52 were -0.33% (-0.50, -0.15) and -0.36% (-0.53, -0.18) in the 5 and 10 mg dapagliflozin groups, respectively.","[{'ForeName': 'Eiichi', 'Initials': 'E', 'LastName': 'Araki', 'Affiliation': 'Department of Metabolic Medicine, Faculty of Life Sciences, Kumamoto University, Kumamoto, Japan.'}, {'ForeName': 'Hirotaka', 'Initials': 'H', 'LastName': 'Watada', 'Affiliation': 'Department of Metabolism and Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Yasuko', 'Initials': 'Y', 'LastName': 'Uchigata', 'Affiliation': ""Diabetes Center, Tokyo Women's Medical University School of Medicine, Tokyo, Japan.""}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Tomonaga', 'Affiliation': 'Diabetes and Lifestyle Center, Tomonaga Clinic, Tokyo, Japan.'}, {'ForeName': 'Hitomi', 'Initials': 'H', 'LastName': 'Fujii', 'Affiliation': 'Internal Medicine, Tama-center Mirai Clinic, Tokyo, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Ohashi', 'Affiliation': 'Internal Medicine, Oyama East Clinic, Tochigi, Japan.'}, {'ForeName': 'Tadashi', 'Initials': 'T', 'LastName': 'Okabe', 'Affiliation': 'Okabe Clinic, Tokyo, Japan.'}, {'ForeName': 'Michiko', 'Initials': 'M', 'LastName': 'Asano', 'Affiliation': 'Research & Development, AstraZeneca K.K., Osaka, Japan.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Thoren', 'Affiliation': 'Global Medicine Development, AstraZeneca Gothenburg, Mölndal, Sweden.'}, {'ForeName': 'Hyosung', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Research & Development, AstraZeneca K.K., Osaka, Japan.'}, {'ForeName': 'Toshitaka', 'Initials': 'T', 'LastName': 'Yajima', 'Affiliation': 'Research & Development, AstraZeneca K.K., Osaka, Japan.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Langkilde', 'Affiliation': 'Global Medicine Development, AstraZeneca Gothenburg, Mölndal, Sweden.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13922']
241,31747464,Population pharmacokinetic modeling of plasma Δ9-tetrahydrocannabinol and an active and inactive metabolite following controlled smoked cannabis administration.,"AIMS


Population pharmacokinetic models of Δ9-tetrahydrocannabinol (THC) have been developed for THC plasma and blood concentration data. Often, only the metabolites of THC are measurable when blood samples are obtained. Therefore, we performed a population pharmacokinetic analysis of THC, 11-OH-THC and THCCOOH plasma concentration data from a Phase I clinical trial of THC smoking.
METHODS


Frequently obtained plasma THC, 11-OH-THC and THCCOOH concentration data were obtained over 168 h from 6 subjects who smoked low (15.8 mg) and high dose (33.8 mg) THC cigarettes on 2 occasions. Bayesian estimates of the THC pharmacokinetic model from each individual for each dose were fixed prior to the sequential pharmacokinetic analysis of the metabolites.
RESULTS


A 3-compartment model of THC was developed that has a steady-state volume of distribution (Vd SS  ) of 3401 ± 788 L and a clearance of 0.72 ± 0.10 L/min. 11-OH-THC was characterized by 50 ± 6% of the THC being directly cleared to a 3-compartment model with a Vd SS  of 415.2 ± 4.3 L and clearance of 0.78 ± 0.05 L/min. The THCCOOH model shared the central compartment of the 11-OH-THC model with a Vd SS  of 29.1 ± 0.05 L and a clearance of 0.12 ± 0.02 L/min. First order kinetics were observed for THC and THCCOOH between the low and high doses, but a nonlinear pattern was observed for 11-OH-THC.
CONCLUSION


We describe the pharmacokinetics of THC, 11-OH-THC and THCCOOH including inter- and intraindividual variability of the parameter estimates of the model.",2020,"First order kinetics were observed for THC and THCCOOH between the low and high doses, but a nonlinear pattern was observed for 11-OH-THC.
","['Frequently obtained plasma THC, 11-OH-THC, and THCCOOH concentration data were obtained over 168 hours from 6 subjects who smoked low (15.8 mg) and high dose (33.8 mg']",['tetrahydrocannabinol'],"['THC plasma and blood concentration data', '11-OH-THC']","[{'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C4319556', 'cui_str': 'One hundred and sixty-eight'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}]","[{'cui': 'C0039663', 'cui_str': 'dronabinol'}]","[{'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C1313904', 'cui_str': 'Blood concentration, test strip measurement'}]",,0.0372779,"First order kinetics were observed for THC and THCCOOH between the low and high doses, but a nonlinear pattern was observed for 11-OH-THC.
","[{'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Sempio', 'Affiliation': 'Department of Anesthesiology, University of Colorado School of Medicine, Aurora, Colorado, USA.'}, {'ForeName': 'Marilyn A', 'Initials': 'MA', 'LastName': 'Huestis', 'Affiliation': 'The Lambert Center for the Study of Medicinal Cannabis and Hemp, The Institute for Emerging Health Professions, Thomas Jefferson University, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Susan K', 'Initials': 'SK', 'LastName': 'Mikulich-Gilbertson', 'Affiliation': 'Department of Psychiatry, Division of Substance Dependence, University of Colorado School of Medicine, Aurora, Colorado, USA.'}, {'ForeName': 'Jost', 'Initials': 'J', 'LastName': 'Klawitter', 'Affiliation': 'Department of Anesthesiology, University of Colorado School of Medicine, Aurora, Colorado, USA.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Christians', 'Affiliation': 'Department of Anesthesiology, University of Colorado School of Medicine, Aurora, Colorado, USA.'}, {'ForeName': 'Thomas K', 'Initials': 'TK', 'LastName': 'Henthorn', 'Affiliation': 'Department of Anesthesiology, University of Colorado School of Medicine, Aurora, Colorado, USA.'}]",British journal of clinical pharmacology,['10.1111/bcp.14170']
242,31747465,Acute caffeine intake increases performance in the 15-s Wingate test during the menstrual cycle.,"AIMS


In male athletes, caffeine is considered an ergogenic aid to increase anaerobic performance during the Wingate anaerobic test (WANT). However, information about the effect of caffeine on WANT performance in female athletes is contradictory. Furthermore, it is unknown whether the ergogenicity of caffeine is present during all the phases of the menstrual cycle. The aim of this study was to investigate the effects of caffeine intake on WANT performance during 3 phases of the menstrual cycle.
METHODS


Thirteen well-trained eumenorrhoeic triathletes participated in a double-blind, placebo-controlled, cross-over experimental trial. On 2 different days in each phase, and in randomized order, participants ingested caffeine (3 mg kg -1  ) or a placebo (cellulose). The menstrual cycle phases were individually characterized as follows: (i) early follicular; (ii) preovulatory; and (iii) midluteal. In each trial, participants performed a 15-s adapted version of the WANT.
RESULTS


In comparison to the placebo, caffeine increased peak power during the WANT in the early follicular (8.6 ± 0.8 vs 8.9 ± 0.9 W/kg, P = .04; effect size [d] = 0.45), preovulatory (8.6 ± 0.9 vs 8.9 ± 0.9 W/kg, P = .04; d = 0.23) and mid-luteal phases (8.6 ± 0.8 vs 8.9 ± 0.9 W/kg, P < .01; d = 0.52).
CONCLUSION


The ergogenic effect of caffeine on WANT peak cycling power was of a similar magnitude in the follicular, preovulatory, and mid-luteal phases. These results suggest that caffeine increases performance in the 15-s Wingate test in women athletes and it might be considered an ergogenic aid to increase anaerobic performance in eumenorrhoeic women during their menstrual cycle.",2020,"In comparison to the placebo, caffeine increased peak power during the WANT in the early follicular (8.6 ± 0.8 vs 8.9 ± 0.9 W/kg, P=0.04; effect size (d)= 0.45), preovulatory (8.6 ± 0.9 vs 8.9 ± 0.9 W/kg, P=0.04; d= 0.23) and mid-luteal phases (8.6 ± 0.8 vs 8.9 ± 0.9 W/kg, P<0.01; d= 0.52).
","['Thirteen well-trained eumenorrheic triathletes', 'women athletes']","['placebo (cellulose', 'caffeine', 'placebo', 'caffeine intake', 'placebo, caffeine', 'Acute caffeine']","['anaerobic performance', 'peak power']","[{'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0007648', 'cui_str': 'Cellulose'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}]","[{'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}]",13.0,0.146453,"In comparison to the placebo, caffeine increased peak power during the WANT in the early follicular (8.6 ± 0.8 vs 8.9 ± 0.9 W/kg, P=0.04; effect size (d)= 0.45), preovulatory (8.6 ± 0.9 vs 8.9 ± 0.9 W/kg, P=0.04; d= 0.23) and mid-luteal phases (8.6 ± 0.8 vs 8.9 ± 0.9 W/kg, P<0.01; d= 0.52).
","[{'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Lara', 'Affiliation': 'Exercise Physiology Laboratory, Camilo José Cela University, Madrid, Spain.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Gutiérrez Hellín', 'Affiliation': 'Exercise Physiology Laboratory, Camilo José Cela University, Madrid, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Ruíz-Moreno', 'Affiliation': 'Exercise Physiology Laboratory, Camilo José Cela University, Madrid, Spain.'}, {'ForeName': 'Blanca', 'Initials': 'B', 'LastName': 'Romero-Moraleda', 'Affiliation': 'Exercise Physiology Laboratory, Camilo José Cela University, Madrid, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Del Coso', 'Affiliation': 'Centre for Sport Studies, Rey Juan Carlos University, Fuenlabrada, Spain.'}]",British journal of clinical pharmacology,['10.1111/bcp.14175']
243,31628477,Lipid Metabolism Links Nutrient-Exercise Timing to Insulin Sensitivity in Men Classified as Overweight or Obese.,"CONTEXT


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


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


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


General community.
PARTICIPANTS


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


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


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


Experiments investigating exercise training and metabolic health should consider nutrient-exercise timing, and exercise performed before versus after nutrient intake (ie, in the fasted state) may exert beneficial effects on lipid utilization and reduce postprandial insulinemia.",2020,Training Study - postprandial glycemia was not differentially affected by 6-weeks of exercise training performed before versus after carbohydrate intake (p>0.05).,"['men classified as overweight or obese', 'Men with overweight/obesity (mean±SD, BMI', 'General community']","['Moderate-intensity cycling performed before versus after mixed-macronutrient breakfast (Acute Study) or carbohydrate (Training Study) ingestion', 'Lipid metabolism links nutrient-exercise']","['oral glucose insulin sensitivity', 'lipid utilization', 'net intramuscular lipid utilization', 'postprandial insulinemia']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C1720722', 'cui_str': 'Mix'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C4553621', 'cui_str': 'With breakfast'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular (qualifier value)'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}]",,0.0399732,Training Study - postprandial glycemia was not differentially affected by 6-weeks of exercise training performed before versus after carbohydrate intake (p>0.05).,"[{'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Edinburgh', 'Affiliation': 'Department for Health, University of Bath, Bath, United Kingdom.'}, {'ForeName': 'Helen E', 'Initials': 'HE', 'LastName': 'Bradley', 'Affiliation': 'School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Nurul-Fadhilah', 'Initials': 'NF', 'LastName': 'Abdullah', 'Affiliation': 'School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Scott L', 'Initials': 'SL', 'LastName': 'Robinson', 'Affiliation': 'School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Oliver J', 'Initials': 'OJ', 'LastName': 'Chrzanowski-Smith', 'Affiliation': 'Department for Health, University of Bath, Bath, United Kingdom.'}, {'ForeName': 'Jean-Philippe', 'Initials': 'JP', 'LastName': 'Walhin', 'Affiliation': 'Department for Health, University of Bath, Bath, United Kingdom.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Joanisse', 'Affiliation': 'School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Konstantinos N', 'Initials': 'KN', 'LastName': 'Manolopoulos', 'Affiliation': 'Institute of Metabolism and Systems Research, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Philp', 'Affiliation': 'Diabetes & Metabolism Division, Garvan Institute of Medical Research, Sydney, New South Wales, Australia.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Hengist', 'Affiliation': 'Department for Health, University of Bath, Bath, United Kingdom.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Chabowski', 'Affiliation': 'Department of Physiology, Medical University of Bialystok, Bialystok, Poland.'}, {'ForeName': 'Frances M', 'Initials': 'FM', 'LastName': 'Brodsky', 'Affiliation': 'Division of Biosciences, University College London, London, United Kingdom.'}, {'ForeName': 'Francoise', 'Initials': 'F', 'LastName': 'Koumanov', 'Affiliation': 'Department for Health, University of Bath, Bath, United Kingdom.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Betts', 'Affiliation': 'Department for Health, University of Bath, Bath, United Kingdom.'}, {'ForeName': 'Dylan', 'Initials': 'D', 'LastName': 'Thompson', 'Affiliation': 'Department for Health, University of Bath, Bath, United Kingdom.'}, {'ForeName': 'Gareth A', 'Initials': 'GA', 'LastName': 'Wallis', 'Affiliation': 'School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Javier T', 'Initials': 'JT', 'LastName': 'Gonzalez', 'Affiliation': 'Department for Health, University of Bath, Bath, United Kingdom.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgz104']
244,31709697,"A food-based, low-energy, low-carbohydrate diet for people with type 2 diabetes in primary care: A randomized controlled feasibility trial.","AIM


To examine the feasibility of a food-based, low-energy, low-carbohydrate diet with behavioural support delivered by practice nurses for patients with type 2 diabetes.
MATERIALS AND METHODS


People with type 2 diabetes and a body mass index (BMI) of ≥30 kg/m 2  were randomized 2:1 to intervention or control (usual care) and assessed at 12 weeks. The intervention comprised an 800-1000 kcal/day, food-based, low-carbohydrate (<26% energy) diet for 8 weeks, followed by a 4-week weight maintenance period and four 15-20-minute appointments with a nurse. Primary outcomes were feasibility of recruitment, fidelity of intervention delivery and retention of participants at 12 weeks. Secondary outcomes included change in weight and HbA1c. Focus groups explored the intervention experience.
RESULTS


Forty-eight people were screened, 33 enrolled and 32 followed-up. Mean (±SD) weight loss in the intervention group was 9.5 kg (± 5.4 kg) compared with 2 kg (± 2.5 kg) in the control group (adjusted difference - 7.5 kg [-11.0 to -4.0, P < 0.001]). Mean reduction in HbA1c in the intervention group was 16.3 mmol/mol (± 13.3 mmol/mol) compared with 0.7 mmol/mol (±4.5 mmol/mol) in the control group (difference - 15.7 mmol/mol [-24.1 to -7.3, P < 0.001]).
CONCLUSIONS


It is feasible to recruit participants to a food-based, low-energy, low-carbohydrate intervention, for practice nurses to deliver the programme in primary care, and to retain participants in both groups. There is evidence of clinically significant short-term improvements in weight and glycaemic control.",2020,"weight loss in the intervention group was 9.5kg(±5.4kg), compared with 2kg(±2.5kg) in the control group (difference -7.5kg (-11.0 to -4.0, p<0.001)).","['People with type 2 diabetes and BMI≥30kg/m 2', 'people with diabetes', '48 people were screened, 33 enrolled, and 32 followed up', 'people with type 2 diabetes in primary care', 'patients with type 2 diabetes']","['Low-energy and low-carbohydrate diets', '800-1000kcal/d, food-based low-carbohydrate', 'intervention or control (usual care', 'A food-based low-energy, low-carbohydrate diet', 'Mean(±SD']","['feasibility of recruitment, fidelity of intervention delivery, and retention of participants at 12\u2009weeks', 'change in weight and HbA1c', 'weight loss', 'weight and glycaemic control', 'Mean reduction in HbA1c', 'glycaemic control']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0259836', 'cui_str': 'Diet, Carbohydrate-Restricted'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",33.0,0.0988013,"weight loss in the intervention group was 9.5kg(±5.4kg), compared with 2kg(±2.5kg) in the control group (difference -7.5kg (-11.0 to -4.0, p<0.001)).","[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Morris', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Aveyard', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Dyson', 'Affiliation': 'NIHR Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Noreik', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Bailey', 'Affiliation': 'Burnham Health Centre, Slough, UK.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Fox', 'Affiliation': 'Bicester Health Centre, Bicester, UK.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Jerome', 'Affiliation': 'PPI representative, the DIAMOND study, University of Oxford, Oxford, UK.'}, {'ForeName': 'Garry D', 'Initials': 'GD', 'LastName': 'Tan', 'Affiliation': 'NIHR Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Susan A', 'Initials': 'SA', 'LastName': 'Jebb', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13915']
245,31797522,Efficacy and safety of ertugliflozin in East/Southeast Asian patients with type 2 diabetes mellitus.,"AIM


Post-hoc analysis of the efficacy and safety of ertugliflozin in East/Southeast (E/SE) Asian patients with type 2 diabetes mellitus (T2DM).
MATERIALS AND METHODS


Efficacy evaluations used data from randomized, double-blind, phase 3 studies: a pool of two 26-week placebo-controlled studies and one 52-week active-comparator (glimepiride) study. Least squares mean change from baseline was calculated for HbA1c, fasting plasma glucose (FPG), body weight (BW) and systolic blood pressure (SBP). Safety evaluation included overall and prespecified adverse events based on pooled data (broad pool) from seven phase 3 studies (including studies in the efficacy analysis).
RESULTS


Among 161 E/SE Asian patients in the placebo pool (ertugliflozin, n = 106), ertugliflozin reduced HbA1c, FPG, BW and SBP from baseline at week 26. The placebo-adjusted changes from baseline for ertugliflozin 5 and 15 mg were: HbA1c, -0.9% and -1.0%; BW, -2.1 and -1.9 kg; and SBP, -3.3 and -3.5 mmHg, respectively. Among 174 E/SE Asian patients in the active-comparator study (ertugliflozin, n = 118), HbA1c changes from baseline at week 52 were -0.6%, -0.6% and -0.7% for ertugliflozin 5 mg, 15 mg and glimepiride, respectively. Ertugliflozin 5 and 15 mg reduced BW from baseline by -4.3 and -4.1 kg, respectively, and SBP by -7.4 and -9.3 mmHg, respectively, compared with glimepiride. Safety findings were generally consistent with overall ertugliflozin safety data published to date.
CONCLUSIONS


Treatment with ertugliflozin was associated with reductions in HbA1c, FPG, BW and SBP, and was generally well tolerated in E/SE Asian patients with T2DM. ClinicalTrials.gov identifier: NCT01986855, NCT01999218, NCT01958671, NCT02099110, NCT02036515, NCT02033889, NCT02226003.",2020,"CONCLUSIONS


Treatment with ertugliflozin was associated with reductions in HbA1c, FPG, BW and SBP and was generally well tolerated in E/SE Asian patients with T2DM.","['East/Southeast Asian patients with type 2 diabetes mellitus', '161 E/SE Asian patients in the', 'Asian patients with type 2 diabetes mellitus (T2DM', 'East/Southeast (E/SE']","['Ertugliflozin', 'placebo', 'glimepiride', 'active comparator (glimepiride', 'placebo pool (ertugliflozin n=106), ertugliflozin', 'ertugliflozin']","['HbA1c, FPG, BW and SBP', 'Efficacy and safety', 'glycated haemoglobin (HbA1c), fasting plasma glucose (FPG), body weight (BW) and systolic blood pressure (SBP']","[{'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C4079805', 'cui_str': 'ertugliflozin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0061323', 'cui_str': 'glimepiride'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0337051', 'cui_str': 'Pool (environment)'}]","[{'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}]",,0.173274,"CONCLUSIONS


Treatment with ertugliflozin was associated with reductions in HbA1c, FPG, BW and SBP and was generally well tolerated in E/SE Asian patients with T2DM.","[{'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, United States.'}, {'ForeName': 'Shrita', 'Initials': 'S', 'LastName': 'Patel', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, United States.'}, {'ForeName': 'Nilo B', 'Initials': 'NB', 'LastName': 'Cater', 'Affiliation': 'Pfizer Inc., New York, New York, United States.'}, {'ForeName': 'Larry', 'Initials': 'L', 'LastName': 'Wu', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, United States.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Huyck', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, United States.'}, {'ForeName': 'Steven G', 'Initials': 'SG', 'LastName': 'Terra', 'Affiliation': 'Pfizer Inc., Andover, Massachusetts, United States.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Hickman', 'Affiliation': 'Pfizer Inc., Groton, Connecticut, United States.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Darekar', 'Affiliation': 'Pfizer R&D UK Ltd, Tadworth, UK.'}, {'ForeName': 'Annpey', 'Initials': 'A', 'LastName': 'Pong', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, United States.'}, {'ForeName': 'Ira', 'Initials': 'I', 'LastName': 'Gantz', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, United States.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13931']
246,32276003,The beneficial role of FeNO in association with GINA guidelines for titration of inhaled corticosteroids in adult asthma: A randomized study.,"PURPOSE


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


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


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


The use of FeNO in association with GINA guidelines has a beneficial role for accurate daily dose of ICS in adult patients with asthma.",2020,"After 3, 6 and 9 months of treatment, the percentage of mild, moderate and severe asthma showed no significant difference between the two groups.","['symptomatic asthmatic patients', 'adult asthma', 'adult patients with asthma']","['GINA group (followed GINA guidelines; N\xa0=\xa086) or GINA\xa0+\xa0FeNO group (followed GINA guidelines\xa0+\xa0FeNO for titration of inhaled corticosteroids - ICS; N\xa0=\xa090', 'exhaled nitric oxide (FeNO', 'GINA']","['percentage of mild, moderate and severe asthma', 'level of FeNO reduction', 'improvement of asthma control test (ACT) score']","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0424093', 'cui_str': 'Initiative'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0581126', 'cui_str': 'Severe asthma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C2733224', 'cui_str': 'Asthma control test score'}]",,0.0308658,"After 3, 6 and 9 months of treatment, the percentage of mild, moderate and severe asthma showed no significant difference between the two groups.","[{'ForeName': 'Tung', 'Initials': 'T', 'LastName': 'Truong-Thanh', 'Affiliation': 'Department of Internal Medicine, Thanh Hoa General Hospital, Thanh Hoa City, Vietnam.'}, {'ForeName': 'Anh', 'Initials': 'A', 'LastName': 'Vo-Thi-Kim', 'Affiliation': 'Department of Public Health, Thang Long University, Hanoi City, Vietnam.'}, {'ForeName': 'Thuc', 'Initials': 'T', 'LastName': 'Vu-Minh', 'Affiliation': 'Department of Airway Diseases, ENT Institute, Hanoi City, Vietnam.'}, {'ForeName': 'Dung', 'Initials': 'D', 'LastName': 'Truong-Viet', 'Affiliation': 'Department of Public Health, Thang Long University, Hanoi City, Vietnam.'}, {'ForeName': 'Huong', 'Initials': 'H', 'LastName': 'Tran-Van', 'Affiliation': 'Department of Public Health, Thang Long University, Hanoi City, Vietnam.'}, {'ForeName': 'Sy', 'Initials': 'S', 'LastName': 'Duong-Quy', 'Affiliation': 'Department of Respiratory Diseases, Lam Dong Medical College, Dalat City, Vietnam; Department of Immuno-Allergology, Penn State Medical College, Hershey, USA. Electronic address: sduongquy.jfvp@gmail.com.'}]",Advances in medical sciences,['10.1016/j.advms.2020.03.001']
247,31486230,"Favourable effect of the sodium-glucose co-transporter-2 inhibitor canagliflozin plus the dipeptidyl peptidase-4 inhibitor teneligliptin in combination on glycaemic fluctuation: An open-label, prospective, randomized, parallel-group comparison trial (the CALMER study).","This multicentre, prospective, randomized, open-label, blinded-endpoint, parallel-group, short-term (4-5 weeks) controlled trial was conducted to investigate the superiority of the effect of reducing mean amplitude of glycaemic excursions (MAGE) during meal tolerance tests (MTTs) for the combination of dipeptidyl peptidase-4 (DPP-4) inhibitor and sodium-glucose co-transporter-2 (SGLT2) inhibitor compared with SGLT2 inhibitor monotherapy. Ninety-nine patients with type 2 diabetes who were taking teneligliptin (20 mg/d) were randomized to one of the following two groups: those who switched to 100 mg/d of canagliflozin (SWITCH group) or those who added 100 mg/d of canagliflozin (COMB group). MAGE in the COMB group was significantly decreased compared with that in the SWITCH group (COMB 117.5 ± 39.8 to 92.2 ± 28.0 mg/dL vs SWITCH 110.7 ± 29.8 to 104.2 ± 27.6 mg/dL; P<0.01). Mean blood glucose decreased significantly during MTTs in both groups, although the extent of the reduction was significantly greater in the COMB group (COMB 142.3 ± 28.7 to 119.5 ± 25.1 mg/dL vs SWITCH 146.4 ± 25.5 to 135.5 ± 22.4 mg/dL; P < 0.01). SGLT2 inhibitor combined with DPP-4 inhibitor therapy strongly reduced glycaemic fluctuation compared with SGLT2 inhibitor monotherapy.",2020,"Mean blood glucose decreased significantly during MTT in both groups, although the extent of the reduction was significantly greater in the COMB group (COMB, 142.3 ± ",['Ninety-nine patients with type 2 diabetes who were taking teneligliptin (20 mg/day'],"['SGLT2i combined with DPP-4i', 'SGLT2 inhibitor canagliflozin', 'SGLT2i monotherapy', 'canagliflozin (SWITCH group) or add 100 mg/day of canagliflozin', 'DPP-4 inhibitor (DPP-4i) and SGLT2 inhibitor (SGLT2i']","['glycemic fluctuation', 'Mean blood glucose', 'mean amplitude of glycemic excursions (MAGE']","[{'cui': 'C3828813', 'cui_str': 'Ninety-nine'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C2981308'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0058353', 'cui_str': 'DPPS'}, {'cui': 'C3273807', 'cui_str': 'Gliflozins'}, {'cui': 'C2974540', 'cui_str': 'canagliflozin'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0231239', 'cui_str': 'Fluctuation'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}]",99.0,0.0275527,"Mean blood glucose decreased significantly during MTT in both groups, although the extent of the reduction was significantly greater in the COMB group (COMB, 142.3 ± ","[{'ForeName': 'Kyu Yong', 'Initials': 'KY', 'LastName': 'Cho', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Nomoto', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Akinobu', 'Initials': 'A', 'LastName': 'Nakamura', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Shinichiro', 'Initials': 'S', 'LastName': 'Kawata', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Hajime', 'Initials': 'H', 'LastName': 'Sugawara', 'Affiliation': 'Third Department of Internal Medicine, Hokkaido P.W.F.A.C Obihiro-Kosei General Hospital, Obihiro, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Takeuchi', 'Affiliation': 'Sapporo Diabetes and Thyroid Clinic, Sapporo, Japan.'}, {'ForeName': 'So', 'Initials': 'S', 'LastName': 'Nagai', 'Affiliation': 'Division of Diabetes and Endocrinology, Department of Medicine, Sapporo Medical Centre, NTT East Corporation, Sapporo, Japan.'}, {'ForeName': 'Kazuhisa', 'Initials': 'K', 'LastName': 'Tsuchida', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Kazuno', 'Initials': 'K', 'LastName': 'Omori', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Yokoyama', 'Affiliation': 'Department of Internal Medicine, Jiyugaoka Medical Clinic, Obihiro, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Manda', 'Affiliation': 'Department of Diabetes Centre, Manda Memorial Hospital, Sapporo, Japan.'}, {'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Kurihara', 'Affiliation': 'Kurihara Clinic, Sapporo, Japan.'}, {'ForeName': 'Shin', 'Initials': 'S', 'LastName': 'Aoki', 'Affiliation': 'Aoki Clinic, Sapporo, Japan.'}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Atsumi', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Miyoshi', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13879']
248,31658381,"AJM300, a novel oral antagonist of α4-integrin, sustains an increase in circulating lymphocytes: A randomised controlled trial in healthy male subjects.","AIMS


AJM300 is an oral antagonist of α4-integrin that reduces inflammation by blocking leucocyte trafficking. This study aimed to investigate safety, tolerability, pharmacokinetics and pharmacodynamics of AJM300 in healthy male subjects.
METHODS


A total of 23 subjects were randomised to receive 240 mg (n = 6), 480 mg (n = 5), 960 mg (n = 6) of AJM300 or the corresponding placebo (n = 2 per group). The study drugs were taken orally 3 times daily after each meal on the first day followed by a 4-day washout period. Thereafter, multiple-dose administration was conducted for 6 consecutive days. The pharmacokinetic parameters of AJM300 and its active metabolite (HCA2969) were assessed, and total white blood cells and the differential cell count were used to determine the pharmacodynamic effects. Adverse events (AEs) were also monitored.
RESULTS


The plasma AJM300 and HCA2969 concentration-time curves displayed a triphasic pattern on Day 1 (single-day administration) and Day 10 (last day of multiple dosing), whereas the concentration of HCA2969 was much higher than that of AJM300. A significant but transient increase in lymphocyte count was observed after AJM300 dosing at all dosages tested compared with the placebo. The increase was sustained over a 24-h period only at the 960-mg dosage. In particular, a significant increase in the lymphocyte count compared to placebo (mean, 50.58%; 95% confidence intervals, 20.40-80.76) was observed at the first 960-mg dose on Day 10. Six (26.1%) subjects reported ≥1 AEs, all of which were mild and resolved spontaneously.
CONCLUSION


The maximal and 24-h sustained pharmacodynamic effects were demonstrated at the 960-mg dosage after oral administration of AJM300 3 times daily for 6 days, which was also found to be safe and well tolerated.",2020,A significant but transient increase in lymphocyte count was observed after AJM300 dosing at all dosages tested compared with the placebo.,"['23 subjects', 'healthy male subjects']","['placebo', 'AJM300 or the corresponding placebo', 'AJM300']","['maximal and 24-hour sustained pharmacodynamic effects', 'Adverse events (AEs', 'concentration of HCA2969', 'lymphocyte count', 'safety, tolerability, pharmacokinetics and pharmacodynamics', 'safe and well tolerated', 'circulating lymphocytes', 'pharmacokinetic parameters of AJM300 and its active metabolite (HCA2969', 'plasma AJM300 and HCA2969 concentration-time curves']","[{'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3852241', 'cui_str': 'AJM300'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0443318', 'cui_str': 'Sustained (qualifier value)'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0200635', 'cui_str': 'Lymphocyte Number'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C4018897', 'cui_str': 'Lymphocyte component of blood'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C3852241', 'cui_str': 'AJM300'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}]",23.0,0.0438678,A significant but transient increase in lymphocyte count was observed after AJM300 dosing at all dosages tested compared with the placebo.,"[{'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Fukase', 'Affiliation': 'CPC Clinic, Medipolis Medical Research Institute, Kagoshima, Japan.'}, {'ForeName': 'Toshifumi', 'Initials': 'T', 'LastName': 'Kajioka', 'Affiliation': 'Clinical Development Department, EA Pharma Co., Ltd, Tokyo, Japan.'}, {'ForeName': 'Ichiro', 'Initials': 'I', 'LastName': 'Oikawa', 'Affiliation': 'Clinical Development Department, EA Pharma Co., Ltd, Tokyo, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Ikeda', 'Affiliation': 'Clinical Development Department, EA Pharma Co., Ltd, Tokyo, Japan.'}, {'ForeName': 'Hidetoshi', 'Initials': 'H', 'LastName': 'Furuie', 'Affiliation': 'OPHAC Hospital, Osaka, Japan.'}]",British journal of clinical pharmacology,['10.1111/bcp.14151']
249,31770456,Evaluation of the effect of P-glycoprotein inhibition and induction on talazoparib disposition in patients with advanced solid tumours.,"AIMS


In vitro data show that talazoparib is a substrate for P-glycoprotein (P-gp) and breast cancer resistance protein transporters. This open-label, 2-arm, drug-drug interaction Phase 1 study in patients with advanced solid tumours assessed the effect of a P-gp inhibitor (itraconazole) and a P-gp inducer (rifampicin) on the pharmacokinetics of a single dose of talazoparib. The safety and tolerability of a single dose of talazoparib with and without itraconazole or rifampicin were also assessed.
METHODS


Thirty-six patients were enrolled (Arm A [itraconazole], n = 19; Arm B [rifampicin], n = 17). Patients in both arms received 2 single oral doses of talazoparib (0.5 mg, Arm A; 1 mg, Arm B) alone and with multiple daily oral doses of itraconazole (Arm A) or rifampicin (Arm B).
RESULTS


Coadministration of itraconazole and talazoparib increased talazoparib area under the plasma concentration-time profile from time 0 extrapolated to infinity by ~56% and maximum observed plasma concentration by ~40% relative to talazoparib alone. Coadministration of rifampicin and talazoparib increased talazoparib maximum observed plasma concentration by approximately 37% (geometric mean ratio 136.6% [90% confidence interval 103.2-180.9]); area under the curve was not affected relative to talazoparib alone (geometric mean ratio 102.0% [90% confidence interval 94.0-110.7]). Talazoparib had an overall safety profile consistent with that observed in prior studies in which talazoparib was administered as a single dose.
CONCLUSION


Coadministration of itraconazole increased talazoparib plasma exposure compared to talazoparib alone. A reduced talazoparib dose is recommended if coadministration of potent P-gp inhibitors cannot be avoided. Similar exposure was observed when talazoparib was administered alone and with rifampicin suggesting that the effect of rifampicin on talazoparib exposure is limited.",2020,"RESULTS


Coadministration of itraconazole and talazoparib increased talazoparib AUC inf  by ~56% and C max  by ~40% relative to talazoparib alone.","['Thirty-six patients were enrolled (Arm A ', 'patients with advanced solid tumors']","['P-gp inhibitor (itraconazole) and a P-gp inducer (rifampin', 'itraconazole', 'talazoparib with and without itraconazole or rifampin', 'P-glycoprotein inhibition and induction', 'rifampin', 'itraconazole (Arm A) or rifampin (Arm B', 'rifampin and talazoparib', 'talazoparib', 'Talazoparib', 'itraconazole and talazoparib']","['overall safety profile', 'talazoparib plasma exposure', 'talazoparib C max', 'talazoparib AUC inf', 'safety and tolerability']","[{'cui': 'C4319606', 'cui_str': 'Thirty-six'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}]","[{'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0035608', 'cui_str': 'rifampicin'}, {'cui': 'C0064113', 'cui_str': 'Itraconazole'}, {'cui': 'C4042960', 'cui_str': '3H-Pyrido(4,3,2-de)phthalazin-3-one, 5-fluoro-8-(4-fluorophenyl)-2,7,8,9-tetrahydro-9-(1-methyl-1H-1,2,4-triazol-5-yl)-, (8S,9R)-'}, {'cui': 'C0242643', 'cui_str': 'ATP Binding Cassette Transporter, Sub-Family B, Member 1'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4042960', 'cui_str': '3H-Pyrido(4,3,2-de)phthalazin-3-one, 5-fluoro-8-(4-fluorophenyl)-2,7,8,9-tetrahydro-9-(1-methyl-1H-1,2,4-triazol-5-yl)-, (8S,9R)-'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0376690', 'cui_str': 'AUC'}]",36.0,0.0852537,"RESULTS


Coadministration of itraconazole and talazoparib increased talazoparib AUC inf  by ~56% and C max  by ~40% relative to talazoparib alone.","[{'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Elmeliegy', 'Affiliation': 'Pfizer Inc., La Jolla, CA, USA.'}, {'ForeName': 'István', 'Initials': 'I', 'LastName': 'Láng', 'Affiliation': 'National Institute of Oncology, Budapest, Hungary.'}, {'ForeName': 'Elena A', 'Initials': 'EA', 'LastName': 'Smolyarchuk', 'Affiliation': 'Sechenov First Moscow State Medical University, Moscow, Russia.'}, {'ForeName': 'Chin-Hee', 'Initials': 'CH', 'LastName': 'Chung', 'Affiliation': 'Pfizer Oncology, New York, NY, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Plotka', 'Affiliation': 'Pfizer Inc., Collegeville, PA, USA.'}, {'ForeName': 'Haihong', 'Initials': 'H', 'LastName': 'Shi', 'Affiliation': 'Pfizer Inc., Groton, CT, USA.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Pfizer Inc., La Jolla, CA, USA.'}]",British journal of clinical pharmacology,['10.1111/bcp.14178']
250,31823222,Clinically Meaningful Responses to Dupilumab in Adolescents with Uncontrolled Moderate-to-Severe Atopic Dermatitis: Post-hoc Analyses from a Randomized Clinical Trial.,"BACKGROUND


Atopic dermatitis is a chronic inflammatory condition with substantial burden and limited treatment options for adolescents with moderate-to-severe disease. Significantly more patients treated with dupilumab vs. placebo achieved Investigator's Global Assessment 0/1 at week 16.
OBJECTIVE


The objective of this study was to assess the impact of dupilumab treatment vs. placebo on the achievement of clinically meaningful improvements in atopic dermatitis signs, symptoms and quality of life.
METHODS


R668-AD-1526 LIBERTY AD ADOL was a randomized, double-blinded, parallel-group, phase III clinical trial. Two hundred and fifty-one adolescents with moderate-to-severe atopic dermatitis received dupilumab 300 mg every 4 weeks (q4w; n = 84), dupilumab 200 or 300 mg every 2 weeks (q2w; n = 82), or placebo (n = 85). A post-hoc subgroup analysis was performed on 214 patients with Investigator's Global Assessment > 1 at week 16. Measures of atopic dermatitis signs, symptoms, and quality of life were assessed. Clinically meaningful improvement in one or more of three domains of signs, symptoms, and quality of life was defined as an improvement of ≥ 50% in Eczema Area and Severity Index, ≥ 3 points in Peak Pruritus Numerical Rating Scale, or ≥ 6 points in the Children's Dermatology Life Quality Index from baseline.
RESULTS


Of patients receiving dupilumab q2w, 80.5% [66/82] experienced clinically meaningful improvements in atopic dermatitis signs, symptoms, or quality of life at week 16 (vs. placebo, 20/85 [23.5%], difference 57.0% [95% confidence interval 44.5-69.4]; q4w vs. placebo, 53/84 [63.1%], difference 39.6% [95% confidence interval 25.9-53.3]; both p < 0.0001). Results were similar in adolescents with Investigator's Global Assessment > 1 at week 16 (q2w, 46/62 [74.2%] vs. placebo, 18/83 [21.7%], difference 52.5% [95% confidence interval 38.5-66.6]; q4w, 38/69 [55.1%] vs. placebo, difference 33.4% [95% confidence interval 18.7-48.1]; both p < 0.0001).
CONCLUSIONS


Dupilumab provided clinically meaningful improvements in signs, symptoms, and quality of life in adolescents with moderate-to-severe atopic dermatitis among patients with Investigator's Global Assessment > 1 at week 16. Treatment responses should be interpreted in the context of such clinically relevant patient-reported outcome measures.
TRIAL REGISTRATION


ClinicalTrials.gov; NCT03054428. Adolescents with atopic dermatitis: does dupilumab improve their signs, symptoms, and quality of life? (MP4  212916 kb).",2020,"Significantly more patients treated with dupilumab vs. placebo achieved Investigator's Global Assessment 0/1 at week 16.
","['Two hundred and fifty-one adolescents with moderate-to-severe atopic dermatitis', 'Adolescents with atopic dermatitis', ""adolescents with moderate-to-severe atopic dermatitis among patients with Investigator's Global Assessment >\u20091 at week 16"", ""214 patients with Investigator's Global Assessment >\u20091 at week 16"", 'Adolescents with Uncontrolled Moderate-to-Severe Atopic Dermatitis', 'adolescents with moderate-to-severe disease']","['dupilumab treatment vs. placebo', 'placebo', 'dupilumab vs. placebo', 'dupilumab 300\xa0mg every 4\xa0weeks (q4w; n\u2009=\u200984), dupilumab 200 or 300 mg every 2\xa0weeks (q2w; n\u2009=\u200982), or placebo']","['atopic dermatitis signs, symptoms, or quality of life', 'atopic dermatitis signs, symptoms, and quality of life', 'signs, symptoms, and quality of life', 'atopic dermatitis signs, symptoms and quality of life']","[{'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0011615', 'cui_str': 'Neurodermatitis, Disseminated'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C4280965', 'cui_str': '>1'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C3660996', 'cui_str': 'dupilumab'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C1275555', 'cui_str': 'q4wk'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0011615', 'cui_str': 'Neurodermatitis, Disseminated'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034380'}]",251.0,0.713213,"Significantly more patients treated with dupilumab vs. placebo achieved Investigator's Global Assessment 0/1 at week 16.
","[{'ForeName': 'Amy S', 'Initials': 'AS', 'LastName': 'Paller', 'Affiliation': 'Department of Dermatology, Northwestern University Feinberg School of Medicine, 676\xa0N. St. Clair, Suite 1600, Chicago, IL, 60611, USA. apaller@northwestern.edu.'}, {'ForeName': 'Ashish', 'Initials': 'A', 'LastName': 'Bansal', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.'}, {'ForeName': 'Eric L', 'Initials': 'EL', 'LastName': 'Simpson', 'Affiliation': 'Department of Dermatology, Oregon Health and Science University, Portland, OR, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Boguniewicz', 'Affiliation': 'Department of Pediatrics, National Jewish Health and University of Colorado School of Medicine, Denver, CO, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Blauvelt', 'Affiliation': 'Oregon Medical Research Center, Portland, OR, USA.'}, {'ForeName': 'Elaine C', 'Initials': 'EC', 'LastName': 'Siegfried', 'Affiliation': ""Department of Pediatrics, Saint Louis University and Cardinal Glennon Children's Hospital, St. Louis, MO, USA.""}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Guttman-Yassky', 'Affiliation': 'Department of Dermatology and the Laboratory for Inflammatory Skin Diseases, Icahn School of Medicine at Mount Sinai and Laboratory for Investigative Dermatology, Rockefeller University, New York, NY, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hultsch', 'Affiliation': 'Sanofi Genzyme, Cambridge, MA, USA.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Mina-Osorio', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.'}, {'ForeName': 'Yufang', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.'}, {'ForeName': 'Ana B', 'Initials': 'AB', 'LastName': 'Rossi', 'Affiliation': 'Sanofi Genzyme, Cambridge, MA, USA.'}, {'ForeName': 'Xinyi', 'Initials': 'X', 'LastName': 'He', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Kamal', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.'}, {'ForeName': 'Neil M H', 'Initials': 'NMH', 'LastName': 'Graham', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Pirozzi', 'Affiliation': 'Sanofi, Bridgewater, NJ, USA.'}, {'ForeName': 'Marcella', 'Initials': 'M', 'LastName': 'Ruddy', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Eckert', 'Affiliation': 'Sanofi, Chilly-Mazarin, France.'}, {'ForeName': 'Abhijit', 'Initials': 'A', 'LastName': 'Gadkari', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.'}]",American journal of clinical dermatology,['10.1007/s40257-019-00478-y']
251,31910916,"Depression, cognitive, and functional outcomes of Problem Adaptation Therapy (PATH) in older adults with major depression and mild cognitive deficits.","OBJECTIVES


Antidepressants have limited efficacy in older adults with depression and cognitive impairment, and psychosocial interventions for this population have been inadequately investigated. Problem Adaptation Therapy (PATH) is a psychosocial intervention for older adults with major depression, cognitive impairment, and disability.
DESIGN


This study tests the efficacy of PATH versus Supportive Therapy for Cognitively Impaired Older Adults (ST-CI) in reducing depression (Montgamery Asberg Depression Rating Scale [MADRS]) and disability (World Health Organization Disability Assessments Schedule-II [WHODAS-II]) and improving cognitive outcomes (Mini Mental State Examination [MMSE]) over 24 weeks (12 weeks of treatment and 12-week post-treatment follow-up).
SETTING


Participants were recruited through collaborating community agencies of Weill Cornell Institute of Geriatric Psychiatry. Both interventions and all research assessments were conducted at home.
PARTICIPANTS


Thirty-five older adults (age ≥ 65 years) with major depression and cognitive impairment no dementia (CIND).
INTERVENTIONS


PATH aims to increase emotion regulation by incorporating a problem-solving approach, teaching compensatory strategies, and inviting caregiver participation. Supportive Therapy aims to facilitate the expression of affect, as well as promote empathy.
MEASUREMENTS


Depression was measured using the MADRS, disability using the WHODAS-II, and cognition using the MMSE.
RESULTS


PATH participants showed significantly greater reduction in MADRS total score (7.04 points at 24 weeks, treatment group by time interaction: F[1,24.4] = 7.61, p = 0.0108), greater improvement in MMSE total score (2.30 points at 24 weeks, treatment group by time interaction: F[1,39.8] = 13.31, p = 0.0008), and greater improvement in WHODAS-II total score (2.95 points at 24 weeks, treatment group by time interaction: F[1,89] = 4.93, p = 0.0290) than ST-CI participants over the 24-week period.
CONCLUSIONS


PATH participants had better depression, cognitive, and disability outcomes than ST-CI participants over 6 months. PATH may provide relief to depressed older adults with CIND who currently have limited treatment options.",2020,"RESULTS


PATH participants showed significantly greater reduction in MADRS total score (7.04 points at 24 weeks, treatment group by time interaction: F[1,24.4] = 7.61, p = 0.0108), greater improvement in MMSE total score (2.30 points at 24 weeks, treatment group by time interaction: F[1,39.8] = 13.31, p = 0.0008), and greater improvement in WHODAS-II total score (2.95 points at 24 weeks, treatment group by time interaction: F[1,89] = 4.93, p = 0.0290) than ST-CI participants over the 24-week period.
","['older adults with depression and cognitive impairment', 'Participants were recruited through collaborating community agencies of Weill Cornell Institute of Geriatric Psychiatry', 'depressed older adults with CIND', 'Cognitively Impaired Older Adults (ST-CI', 'older adults with major depression, cognitive impairment, and disability', 'older adults with major depression and mild cognitive deficits', 'Thirty-five older adults (age ≥ 65 years) with major depression and cognitive impairment no dementia (CIND']","['Problem Adaptation Therapy (PATH', 'PATH versus Supportive Therapy']","['MADRS total score', 'WHODAS-II total score', 'MMSE total score', 'Depression', 'depression, cognitive, and disability outcomes', 'MADRS, disability using the WHODAS-II, and cognition using the MMSE', 'Depression, cognitive, and functional outcomes', 'depression (Montgamery Asberg Depression Rating Scale [MADRS]) and disability (World Health Organization Disability Assessments Schedule-II [WHODAS-II]) and improving cognitive outcomes (Mini Mental State Examination [MMSE']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0017467', 'cui_str': 'Psychogeriatrics'}, {'cui': 'C0221099', 'cui_str': 'Impaired (qualifier value)'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C4319605', 'cui_str': 'Thirty-five'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}]","[{'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0392673', 'cui_str': 'Adaptation, function (observable entity)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0451306', 'cui_str': 'Folstein Mini-Mental State Examination'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0451124', 'cui_str': 'Disability assessment schedule (assessment scale)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}]",35.0,0.0346848,"RESULTS


PATH participants showed significantly greater reduction in MADRS total score (7.04 points at 24 weeks, treatment group by time interaction: F[1,24.4] = 7.61, p = 0.0108), greater improvement in MMSE total score (2.30 points at 24 weeks, treatment group by time interaction: F[1,39.8] = 13.31, p = 0.0008), and greater improvement in WHODAS-II total score (2.95 points at 24 weeks, treatment group by time interaction: F[1,89] = 4.93, p = 0.0290) than ST-CI participants over the 24-week period.
","[{'ForeName': 'Dora', 'Initials': 'D', 'LastName': 'Kanellopoulos', 'Affiliation': 'Weill Cornell Institute of Geriatric Psychiatry, Weill Cornell Medicine, New York, NY, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Rosenberg', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Lisa D', 'Initials': 'LD', 'LastName': 'Ravdin', 'Affiliation': 'Department of Neurology & Neuroscience, Weill Cornell Medicine, New York, NY, USA.'}, {'ForeName': 'Dalynah', 'Initials': 'D', 'LastName': 'Maldonado', 'Affiliation': 'Department of Medicine/Rheumatology, Albert Einstein College of Medicine, Bronx, NY, USA.'}, {'ForeName': 'Nimra', 'Initials': 'N', 'LastName': 'Jamil', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Crystal', 'Initials': 'C', 'LastName': 'Quinn', 'Affiliation': 'The Graduate Center, City University of New York, New York, NY, USA.'}, {'ForeName': 'Dimitris N', 'Initials': 'DN', 'LastName': 'Kiosses', 'Affiliation': 'Weill Cornell Institute of Geriatric Psychiatry, Weill Cornell Medicine, New York, NY, USA.'}]",International psychogeriatrics,['10.1017/S1041610219001716']
252,31956998,Pharmacokinetics and Pharmacodynamics of Intensive Antituberculosis Treatment of Tuberculous Meningitis.,"The most effective antituberculosis drug treatment regimen for tuberculous meningitis is uncertain. We conducted a randomized controlled trial comparing standard treatment with a regimen intensified by rifampin 15 mg/kg and levofloxacin for the first 60 days. The intensified regimen did not improve survival or any other outcome. We therefore conducted a nested pharmacokinetic/pharmacodynamic study in 237 trial participants to define exposure-response relationships that might explain the trial results and improve future therapy. Rifampin 15 mg/kg increased plasma and cerebrospinal fluid (CSF) exposures compared with 10 mg/kg: day 14 exposure increased from 48.2 hour·mg/L (range 18.2-93.8) to 82.5 hour·mg/L (range 8.7-161.0) in plasma and from 3.5 hour·mg/L (range 1.2-9.6) to 6.0 hour·mg/L (range 0.7-15.1) in CSF. However, there was no relationship between rifampin exposure and survival. In contrast, we found that isoniazid exposure was associated with survival, with low exposure predictive of death, and was linked to a fast metabolizer phenotype. Higher doses of isoniazid should be investigated, especially in fast metabolizers.",2020,Rifampin 15mg/kg increased plasma and CSF exposures compared to 10mg/kg: day 14 plasma AUC 0-24  increased from 48.2h∙mg/L (range 18.2-93.8) to 82.5h∙mg/L (range 8.7-161.0) and CSF AUC 0-24  from 3.5h∙mg/L (range 1.2-9.6) to 6.0h∙mg/L (range 0.7-15.1).,"['tuberculous meningitis', '237 trial participants']","['rifampin 15mg/kg and levofloxacin', 'isoniazid', 'intensive anti-tuberculosis treatment']","['survival', 'plasma and CSF exposures', 'rifampin exposure and survival']","[{'cui': 'C0041318', 'cui_str': 'Tubercular Meningitis'}]","[{'cui': 'C0035608', 'cui_str': 'rifampicin'}, {'cui': 'C0282386', 'cui_str': 'Levofloxacin'}, {'cui': 'C0022209', 'cui_str': 'isoniazid'}, {'cui': 'C0041296', 'cui_str': 'Mycobacterium tuberculosis Infection'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0035608', 'cui_str': 'rifampicin'}]",,0.121718,Rifampin 15mg/kg increased plasma and CSF exposures compared to 10mg/kg: day 14 plasma AUC 0-24  increased from 48.2h∙mg/L (range 18.2-93.8) to 82.5h∙mg/L (range 8.7-161.0) and CSF AUC 0-24  from 3.5h∙mg/L (range 1.2-9.6) to 6.0h∙mg/L (range 0.7-15.1).,"[{'ForeName': 'Junjie', 'Initials': 'J', 'LastName': 'Ding', 'Affiliation': 'Nuffield Department of Clinical Medicine, Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Nguyen', 'Initials': 'N', 'LastName': 'Thuy Thuong Thuong', 'Affiliation': 'Oxford University Clinical Research Unit, Centre for Tropical Medicine, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Toi Van', 'Initials': 'TV', 'LastName': 'Pham', 'Affiliation': 'Oxford University Clinical Research Unit, Centre for Tropical Medicine, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Dorothee', 'Initials': 'D', 'LastName': 'Heemskerk', 'Affiliation': 'Oxford University Clinical Research Unit, Centre for Tropical Medicine, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Pouplin', 'Affiliation': 'Nuffield Department of Clinical Medicine, Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Chau Thi Hong', 'Initials': 'CTH', 'LastName': 'Tran', 'Affiliation': 'Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Mai Thi Hoang', 'Initials': 'MTH', 'LastName': 'Nguyen', 'Affiliation': 'Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Phu Hoan', 'Initials': 'PH', 'LastName': 'Nguyen', 'Affiliation': 'Oxford University Clinical Research Unit, Centre for Tropical Medicine, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Loc Phu', 'Initials': 'LP', 'LastName': 'Phan', 'Affiliation': 'Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Chau Van Vinh', 'Initials': 'CVV', 'LastName': 'Nguyen', 'Affiliation': 'Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Thwaites', 'Affiliation': 'Nuffield Department of Clinical Medicine, Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Tarning', 'Affiliation': 'Nuffield Department of Clinical Medicine, Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, UK.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.1783']
253,31886629,Autologous adipose-derived stem cells for the treatment of complex cryptoglandular perianal fistula: A randomized clinical trial with long-term follow-up.,"The aim of this clinical trial (ID Number NCT01803347) was to determine the safety and efficacy of autologous adipose-derived stem cells (ASCs) for treatment of cryptoglandular fistula. This research was conducted following an analysis of the mistakes of a same previous phase III clinical trial. We designed a multicenter, randomized, single-blind clinical trial, recruiting 57 patients. Forty-four patients were categorized as belonging to the intent-to-treat group. Of these, 23 patients received 100 million ASCs plus intralesional fibrin glue (group A) and 21 received intralesional fibrin glue (group B), both after a deeper curettage of tracks and closure of internal openings. Fistula healing was defined as complete re-epithelialization of external openings. Those patients in whom the fistula had not healed after 16 weeks were eligible for retreatment. Patients were evaluated at 1, 4, 16, 36, and 52 weeks and 2 years after treatment. Results were assessed by an evaluator blinded to the type of treatment. After 16 weeks, the healing rate was 30.4% in group A and 42.8% in group B, rising to 55.0% and 63.1%, respectively, at 52 weeks. At the end of the study (2 years after treatment), the healing rate remained at 50.0% in group A and had reduced to 26.3% in group B. The safety of the cellular treatment was confirmed and no impact on fecal continence was detected. The main conclusion was that autologous ASCs for the treatment of cryptoglandular perianal fistula is safe and can favor long-term and sustained fistula healing.",2020,"After 16 weeks, the healing rate was 30.4% in group A and 42.8% in group B, rising to 55.0% and 63.1%, respectively, at 52 weeks.","['complex cryptoglandular perianal fistula', 'Those patients in whom the fistula had not healed after 16\u2009weeks were eligible for retreatment', '23 patients received 100 million', '57 patients']","['ASCs plus intralesional fibrin glue', 'autologous adipose-derived stem cells (ASCs', 'Autologous adipose-derived stem cells', 'intralesional fibrin glue']","['healing rate', 'safety and efficacy', 'fecal continence', 'Fistula healing']","[{'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0267561', 'cui_str': 'Fistula of perianal skin'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0205249', 'cui_str': 'Healed (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0376495', 'cui_str': 'Retreatments'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0016004', 'cui_str': 'Fibrin Glue'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0038250', 'cui_str': 'Mother Cells'}]","[{'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0429956', 'cui_str': 'Bowels: fully continent (finding)'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}]",57.0,0.108501,"After 16 weeks, the healing rate was 30.4% in group A and 42.8% in group B, rising to 55.0% and 63.1%, respectively, at 52 weeks.","[{'ForeName': 'Mariano', 'Initials': 'M', 'LastName': 'Garcia-Arranz', 'Affiliation': 'Department of Surgery and New Therapy Laboratory, Health Research Institute Fundación Jiménez Díaz (FIIS-FJD), Universidad Autónoma de Madrid (UAM), Madrid, Spain.'}, {'ForeName': 'Damián', 'Initials': 'D', 'LastName': 'Garcia-Olmo', 'Affiliation': 'Department of Surgery and New Therapy Laboratory, Health Research Institute Fundación Jiménez Díaz (FIIS-FJD), Universidad Autónoma de Madrid (UAM), Madrid, Spain.'}, {'ForeName': 'María Dolores', 'Initials': 'MD', 'LastName': 'Herreros', 'Affiliation': 'Department of Surgery and New Therapy Laboratory, Health Research Institute Fundación Jiménez Díaz (FIIS-FJD), Universidad Autónoma de Madrid (UAM), Madrid, Spain.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Gracia-Solana', 'Affiliation': 'Department of Colorectal Surgery, ""Lozano Blesa"" University Hospital, Aragon Health Sciences Institute, Zaragoza, Spain.'}, {'ForeName': 'Héctor', 'Initials': 'H', 'LastName': 'Guadalajara', 'Affiliation': 'Department of Surgery and New Therapy Laboratory, Health Research Institute Fundación Jiménez Díaz (FIIS-FJD), Universidad Autónoma de Madrid (UAM), Madrid, Spain.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'de la Portilla', 'Affiliation': 'Coloproctology Unit, Gastrointestinal Surgery Department, Virgen del Rocio University Hospital, Sevilla, Spain.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Baixauli', 'Affiliation': 'Coloproctology Unit, Department of General and Digestive Surgery, University Hospital of Salamanca, Salamanca, Spain.'}, {'ForeName': 'Jacinto', 'Initials': 'J', 'LastName': 'Garcia-Garcia', 'Affiliation': 'Colorectal Surgery Unit, Department of General Surgery, Clínica Universitaria de Navarra, University of Navarra, Pamplona, Spain.'}, {'ForeName': 'José Manuel', 'Initials': 'JM', 'LastName': 'Ramirez', 'Affiliation': 'Department of Colorectal Surgery, ""Lozano Blesa"" University Hospital, Aragon Health Sciences Institute, Zaragoza, Spain.'}, {'ForeName': 'Fermín', 'Initials': 'F', 'LastName': 'Sanchez-Guijo', 'Affiliation': 'Cell Therapy Area, IBSAL-University Hospital, University of Salamanca, Salamanca, Spain.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Prosper', 'Affiliation': 'GMP Laboratory Cellular Therapy, Clínica Universitaria de Navarra, University of Navarra, Pamplona, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Stem cells translational medicine,['10.1002/sctm.19-0271']
254,32032916,The effects of ondansetron versus dexamethasone on electrocardiographic markers of ventricular repolarization in children undergoing cochlear implant.,"INTRODUCTION


Congenital hearing loss is associated with cardiac rhythm disturbances namely long Q-T syndrome. This study was designed to investigate the effect of anti-emetic doses of ondansetron and dexamethasone on ECG recordings in children undergoing cochlear implant surgery.
METHODS


Sixty-three pediatric patients scheduled for elective cochlear implantation were enrolled in the study. Two patients were excluded as their baseline ECG showed long QT syndrome. Anesthesia was induced with fentanyl, propofol and atracurium and maintained with propofol. Dexamethasone 0.1 mg.kg -1 or ondansetron 0.2 mg.kg -1 was randomly administered for the participants approximately 30 min before the end of surgery. ECG recording was performed 15 min after induction of anesthesia and 15 min after dexamethasone/ondansetron administration. RR interval, QRS duration, QT interval, and Tp-e interval were measured by a blinded cardiologist.
RESULTS


Ondansetron resulted in no significant changes in RR, JTc and QTc intervals; while prolongedTp-e interval. Multivariable logistic regression analysis showed that use of ondansetron was an independent predictor of QTc prolongation after adjustment for age, gender and baseline QTc (OR = 17.94, CI 95% 1.97-168.70, p = 0.011). The incidence of postoperative retching/vomiting in ondansetron group was significantly lower than dexamethasone group. (3.2% vs. 26.7%, p = 0.011).
CONCLUSION


The risk of arrhythmias with the use of ondansetron in otherwise healthy candidates of cochlear implant is very low. However, the drug may induce significant changes in ECG parameters. The clinical significance of these changes in patients with cardiac conduction abnormalities should be investigated in further studies.",2020,"RESULTS


Ondansetron resulted in no significant changes in RR, JTc and QTc intervals; while prolongedTp-e interval.","['children undergoing cochlear implant surgery', 'children undergoing cochlear implant', 'Sixty-three pediatric patients scheduled for elective cochlear implantation were enrolled in the study', 'patients with cardiac conduction abnormalities']","['dexamethasone', 'dexamethasone/ondansetron', 'Ondansetron', 'ondansetron', 'ondansetron and dexamethasone', 'ondansetron 0.2', 'Dexamethasone 0.1', 'fentanyl, propofol and atracurium and maintained with propofol']","['RR, JTc and QTc intervals', 'ECG parameters', 'electrocardiographic markers of ventricular repolarization', 'postoperative retching/vomiting', 'RR interval, QRS duration, QT interval, and Tp-e interval', 'QTc prolongation']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0009199', 'cui_str': 'Auditory Prosthesis'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C4319614', 'cui_str': '63 (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0302559', 'cui_str': 'Cochlear Prosthesis Implantation'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0232217', 'cui_str': 'Cardiac conduction (observable entity)'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0061851', 'cui_str': 'Ondansetron'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0004234', 'cui_str': 'Atracurium'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}]","[{'cui': 'C0860814', 'cui_str': 'QTc'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C1623258', 'cui_str': 'ECG'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0429028', 'cui_str': 'QT interval feature'}]",2.0,0.14821,"RESULTS


Ondansetron resulted in no significant changes in RR, JTc and QTc intervals; while prolongedTp-e interval.","[{'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Safaeian', 'Affiliation': 'Department of Anesthesiology, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Valiollah', 'Initials': 'V', 'LastName': 'Hassani', 'Affiliation': 'Department of Anesthesiology, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Alimohamad', 'Initials': 'A', 'LastName': 'Asghari', 'Affiliation': 'Skull Base Research Center, The Five Senses Health Research Institute, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Masood', 'Initials': 'M', 'LastName': 'Mohseni', 'Affiliation': 'Department of Anesthesiology, Iran University of Medical Sciences, Tehran, Iran. Electronic address: Masood.mohseni@gmail.com.'}, {'ForeName': 'Haleh', 'Initials': 'H', 'LastName': 'Ashraf', 'Affiliation': 'Cardiac Primary Prevention Research Center (CPPRC), Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Zahra Sadat', 'Initials': 'ZS', 'LastName': 'Koleini', 'Affiliation': 'Department of Anesthesiology, Iran University of Medical Sciences, Tehran, Iran.'}]",International journal of pediatric otorhinolaryngology,['10.1016/j.ijporl.2020.109896']
255,31675420,"Impact of Hormonal Contraceptives on Cervical T-helper 17 Phenotype and Function in Adolescents: Results from a Randomized, Crossover Study Comparing Long-acting Injectable Norethisterone Oenanthate (NET-EN), Combined Oral Contraceptive Pills, and Combined Contraceptive Vaginal Rings.","BACKGROUND


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


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


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


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


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


CCVR use for the first 16-weeks was associated with reduced Th17 frequencies and lower FHS and LH concentrations compared to NET-EN/COCPs, with FHS concentrations and Th17 frequencies correlating significantly.","[{'ForeName': 'Iyaloo N', 'Initials': 'IN', 'LastName': 'Konstantinus', 'Affiliation': 'Institute of Infectious Diseases and Molecular Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Balle', 'Affiliation': 'Institute of Infectious Diseases and Molecular Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Shameem Z', 'Initials': 'SZ', 'LastName': 'Jaumdally', 'Affiliation': 'Institute of Infectious Diseases and Molecular Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Hoyam', 'Initials': 'H', 'LastName': 'Galmieldien', 'Affiliation': 'Institute of Infectious Diseases and Molecular Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Pidwell', 'Affiliation': 'Desmond Tutu Human Immunodeficiency Virus Centre, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Lindi', 'Initials': 'L', 'LastName': 'Masson', 'Affiliation': 'Institute of Infectious Diseases and Molecular Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Ramla F', 'Initials': 'RF', 'LastName': 'Tanko', 'Affiliation': 'Institute of Infectious Diseases and Molecular Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Anna-Ursula', 'Initials': 'AU', 'LastName': 'Happel', 'Affiliation': 'Institute of Infectious Diseases and Molecular Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Musalula', 'Initials': 'M', 'LastName': 'Sinkala', 'Affiliation': 'Institute of Infectious Diseases and Molecular Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Landon', 'Initials': 'L', 'LastName': 'Myer', 'Affiliation': 'Division of Epidemiology and Biostatistics, School of Public Health and Family Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Bosinger', 'Affiliation': 'Department of Pathology & Laboratory Medicine, Emory University School of Medicine, Atlanta, USA.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Gill', 'Affiliation': 'Desmond Tutu Human Immunodeficiency Virus Centre, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Linda-Gail', 'Initials': 'LG', 'LastName': 'Bekker', 'Affiliation': 'Institute of Infectious Diseases and Molecular Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Heather B', 'Initials': 'HB', 'LastName': 'Jaspan', 'Affiliation': 'Institute of Infectious Diseases and Molecular Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Jo-Ann S', 'Initials': 'JS', 'LastName': 'Passmore', 'Affiliation': 'Institute of Infectious Diseases and Molecular Medicine, University of Cape Town, Cape Town, South Africa.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz1063']
256,31514201,The effect of methylphenidate on social cognition and oxytocin in children with attention deficit hyperactivity disorder.,"The current study aimed to explore the possible effect of stimulants on oxytocin (OT), a neuropeptide which regulates social behavior, as a mediator of the pro-social effect of methylphenidate (MPH) in children with attention deficit hyperactivity disorder (ADHD) compared to healthy controls (HCs). Utilizing a double-blind placebo-controlled design, we compared the performance of 50 children with ADHD and 40 HCs in ""theory of mind"" (ToM) tasks and examined the effect of a single dose of MPH/placebo on ToM and salivary OT levels in children with ADHD at baseline and following an interpersonal interaction. Children with ADHD displayed significantly poorer ToM performance; however, following MPH administration, their performance normalized and differences between children with ADHD and HC were no longer found. Salivary OT levels at baseline did not differ between children with ADHD and HCs. However, after a parent-child interaction, OT levels were significantly higher in the HC group compared to children with ADHD. Administration of MPH attenuated this difference such that after parent-child interaction differences in OT levels between children with ADHD and HC were no longer found. In the ADHD group, OT levels decreased from administration of placebo to the parent-child interaction. However, the administration of MPH to children with ADHD was associated with an increase in OT levels after the parent-child interaction. We conclude that OT might play a role as a mediator of social deficits in children with ADHD and that the reactivity of the OT system to social interaction in children with ADHD might be impaired. Stimulants may improve ToM and social functions in children with ADHD via its impact on the OT system. PRS: OT and Social Cognition in Children with ADHD: Impact of MPH.",2020,"However, after a parent-child interaction, OT levels were significantly higher in the HC group compared to children with ADHD.","['Children with ADHD', 'children with attention deficit hyperactivity disorder (ADHD', '50 children with ADHD and 40 HCs in ""theory of mind"" (ToM) tasks', 'children with ADHD at baseline and following an interpersonal interaction', 'children with attention deficit hyperactivity disorder', 'children with ADHD']","['methylphenidate', 'HC', 'MPH', 'MPH/placebo', 'oxytocin (OT', 'placebo', 'methylphenidate (MPH']","['ToM and social functions', 'poorer ToM performance', 'Salivary OT levels', 'social cognition and oxytocin', 'ToM and salivary OT levels', 'OT levels']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0935573', 'cui_str': 'Mentalizing'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}]","[{'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0048853', 'cui_str': 'MPH'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}]",50.0,0.04804,"However, after a parent-child interaction, OT levels were significantly higher in the HC group compared to children with ADHD.","[{'ForeName': 'Orit', 'Initials': 'O', 'LastName': 'Levi-Shachar', 'Affiliation': 'Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Hila Z', 'Initials': 'HZ', 'LastName': 'Gvirts', 'Affiliation': 'Department of Behavioral Sciences and Psychology, Ariel University, Ariel, Israel.'}, {'ForeName': 'Yiftach', 'Initials': 'Y', 'LastName': 'Goldwin', 'Affiliation': 'Shalvata Mental Health Center, Hod-Hasharon, Israel.'}, {'ForeName': 'Yuval', 'Initials': 'Y', 'LastName': 'Bloch', 'Affiliation': 'Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Shamay-Tsoory', 'Affiliation': 'Department of Psychology, Haifa University, Haifa, Israel.'}, {'ForeName': 'Orna', 'Initials': 'O', 'LastName': 'Zagoory-Sharon', 'Affiliation': 'Baruch Ivcher School of Psychology, Interdisciplinary Center, Herzlia, Israel.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Feldman', 'Affiliation': 'Baruch Ivcher School of Psychology, Interdisciplinary Center, Herzlia, Israel.'}, {'ForeName': 'Hagai', 'Initials': 'H', 'LastName': 'Maoz', 'Affiliation': 'Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel. hagaima@gmail.com.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0522-5']
257,32108274,Is the whole larger than the sum of its parts? Impact of missing data imputation in economic evaluation conducted alongside randomized controlled trials.,"Outcomes in economic evaluations, such as health utilities and costs, are products of multiple variables, often requiring complete item responses to questionnaires. Therefore, missing data are very common in cost-effectiveness analyses. Multiple imputations (MI) are predominately recommended and could be made either for individual items or at the aggregate level. We, therefore, aimed to assess the precision of both MI approaches (the item imputation vs. aggregate imputation) on the cost-effectiveness results. The original data set came from a cluster-randomized, controlled trial and was used to describe the missing data pattern and compare the differences in the cost-effectiveness results between the two imputation approaches. A simulation study with different missing data scenarios generated based on a complete data set was used to assess the precision of both imputation approaches. For health utility and cost, patients more often had a partial (9% vs. 23%, respectively) rather than complete missing (4% vs. 0%). The imputation approaches differed in the cost-effectiveness results (the item imputation: - 61,079€/QALY vs. the aggregate imputation: 15,399€/QALY). Within the simulation study mean relative bias (< 5% vs. < 10%) and range of bias (< 38% vs. < 83%) to the true incremental cost and incremental QALYs were lower for the item imputation compared to the aggregate imputation. Even when 40% of data were missing, relative bias to true cost-effectiveness curves was less than 16% using the item imputation, but up to 39% for the aggregate imputation. Thus, the imputation strategies could have a significant impact on the cost-effectiveness conclusions when more than 20% of data are missing. The item imputation approach has better precision than the imputation at the aggregate level.",2020,"For health utility and cost, patients more often had a partial (9% vs. 23%, respectively) rather than complete missing (4% vs. 0%).",[],[],"['true incremental cost and incremental QALYs', 'health utilities and costs, are products of multiple variables, often requiring complete item responses to questionnaires', 'cost-effectiveness conclusions']",[],[],"[{'cui': 'C0205238', 'cui_str': 'True (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.0336039,"For health utility and cost, patients more often had a partial (9% vs. 23%, respectively) rather than complete missing (4% vs. 0%).","[{'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Michalowsky', 'Affiliation': 'German Center for Neurodegenerative Diseases (DZNE), Site Rostock/Greifswald, Ellernholzstrasse 1-2, 17487, Greifswald, Germany. bernhard.michalowsky@dzne.de.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Hoffmann', 'Affiliation': 'German Center for Neurodegenerative Diseases (DZNE), Site Rostock/Greifswald, Ellernholzstrasse 1-2, 17487, Greifswald, Germany.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Kennedy', 'Affiliation': 'Department of Health Research Methods, Evidence and Impact (Formerly Clinical Epidemiology and Biostatistics), McMaster University, 1280 Main Street West, Hamilton, Canada.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Xie', 'Affiliation': 'Department of Health Research Methods, Evidence and Impact (Formerly Clinical Epidemiology and Biostatistics), McMaster University, 1280 Main Street West, Hamilton, Canada.'}]",The European journal of health economics : HEPAC : health economics in prevention and care,['10.1007/s10198-020-01166-z']
258,31646724,Similar glycaemic control and less hypoglycaemia during active titration after insulin initiation with glargine 300 units/mL and degludec 100 units/mL: A subanalysis of the BRIGHT study.,"AIM


To further investigate glycaemic control and hypoglycaemia in BRIGHT, focusing on the titration period.
MATERIALS AND METHODS


BRIGHT was a multicentre, open-label, randomized, active-controlled, two-arm, parallel-group, 24-week study in insulin-naïve patients with uncontrolled type 2 diabetes initiated on glargine 300 U/mL (Gla-300) (N = 466) or degludec (IDeg-100) (N = 463). Predefined efficacy and safety outcomes were investigated during the initial 12-week titration period. In addition, patients' characteristics and clinical outcomes were assessed descriptively, stratified by confirmed (≤3.9 mmol/L) hypoglycaemia incidence during the initial titration period.
RESULTS


At week 12, HbA1c was comparable between Gla-300 (7.32%) and IDeg-100 (7.23%), with similar least squares (LS) mean reductions from baseline (-1.37% and - 1.39%, respectively; LS mean difference of 0.02; 95% confidence interval: -0.08 to 0.12). Patients who experienced hypoglycaemia during the initial titration period had numerically greater HbA1c reductions by week 12 than patients who did not (-1.46% vs. -1.28%), and higher incidence of anytime (24 hours; 73.3% vs. 35.7%) and nocturnal (00:00-06:00 hours; 30.0% vs. 11.9%) hypoglycaemia between weeks 13-24.
CONCLUSIONS


The use of Gla-300 resulted in similar glycaemic control as IDeg-100 during the initial 12-week titration period of the BRIGHT study, when less anytime (24 hours) hypoglycaemia with Gla-300 versus IDeg-100 has been reported. Experiencing hypoglycaemia shortly after initiating Gla-300 or IDeg-100 may be associated with hypoglycaemia incidence in the longer term, potentially impacting glycaemic management.",2020,"At week 12, HbA 1c  was comparable between Gla-300 (7.32 %) and IDeg-100 (7.23 %), with similar least squares (LS) mean reductions from baseline (-1.37 % and -1.39 %, respectively; LS mean difference of 0.02; 95% confidence interval: -0.08 to 0.12).",['naïve patients with uncontrolled type 2 diabetes initiated on Gla-300 (N=466) or IDeg-100 (N=463'],"['Gla-300 vs IDeg-100', 'insulin', 'insulin glargine']","['nocturnal', 'hypoglycaemia incidence', 'hypoglycaemia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}]","[{'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",,0.0841949,"At week 12, HbA 1c  was comparable between Gla-300 (7.32 %) and IDeg-100 (7.23 %), with similar least squares (LS) mean reductions from baseline (-1.37 % and -1.39 %, respectively; LS mean difference of 0.02; 95% confidence interval: -0.08 to 0.12).","[{'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Cheng', 'Affiliation': 'Department of Medicine, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Stewart', 'Initials': 'S', 'LastName': 'Harris', 'Affiliation': 'Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Giorgino', 'Affiliation': 'Department of Emergency and Organ Transplantation, Section of Internal Medicine, Endocrinology, Andrology and Metabolic Diseases, University of Bari Aldo Moro, Bari, Italy.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Seufert', 'Affiliation': 'Division of Endocrinology and Diabetology, Department of Medicine II, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Ritzel', 'Affiliation': 'Division of Endocrinology, Diabetes and Angiology, Klinikum Schwabing and Klinikum Bogenhausen, Munich, Germany.'}, {'ForeName': 'Kamlesh', 'Initials': 'K', 'LastName': 'Khunti', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester, UK.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Lauand', 'Affiliation': 'Sanofi, Paris, France.'}, {'ForeName': 'Lydie', 'Initials': 'L', 'LastName': 'Melas-Melt', 'Affiliation': 'IVIDATA, Levallois-Perret, France.'}, {'ForeName': 'Jukka', 'Initials': 'J', 'LastName': 'Westerbacka', 'Affiliation': 'Sanofi, Paris, France.'}, {'ForeName': 'Zsolt', 'Initials': 'Z', 'LastName': 'Bosnyak', 'Affiliation': 'Sanofi, Paris, France.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Rosenstock', 'Affiliation': 'Dallas Diabetes Research Center at Medical City, Dallas, Texas, United States.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13901']
259,31758576,"First-in-human, randomized dose-escalation study of the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of PF-06480605 in healthy subjects.","AIMS


Human genetic, tissue expression, proteomics, transcriptomics and nonclinical studies implicate tumour necrosis factor α-like ligand 1A (TL1A) as a novel target in inflammatory bowel disease (IBD). PF-06480605, a fully human immunoglobulin G1 monoclonal antibody, targets TL1A. This first-in-human, Phase 1, dose-escalation study assessed safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of intravenous (IV) and subcutaneous (SC) PF-06480605 in healthy subjects (NCT01989143).
METHODS


Ninety-two subjects were randomized to single ascending doses (SAD), PF-06480605 1 mg, 3 mg, 10 mg, 30 mg, 100 mg, 300 mg, 600 mg or 800 mg IV, or multiple ascending doses (MAD), PF-06480605 3 × 500 mg IV, or 3 × 30 mg, 3 × 100 mg, or 3 × 300 mg SC every 2 weeks for three doses, or placebo. Safety, tolerability, pharmacokinetics, immunogenicity profiles and total TL1A, anti-drug antibody (ADA) and neutralizing antibody (NAb) levels were assessed at pre-determined times.
RESULTS


PF-06480605 SAD up to 800 mg IV and MAD up to 300 mg ×3 SC and 500 mg ×3 IV were well tolerated. Overall, there were 45 and 44 treatment-emergent adverse events in SAD and MAD cohorts, respectively, and no deaths or serious adverse events. PF-06480605 exposure generally increased dose-dependently. ADA and NAb levels did not impact safety, pharmacokinetics, or pharmacodynamics at higher doses. Target engagement was demonstrated through dose-dependent differences in serum total soluble TL1A concentrations for PF-06480605 vs placebo cohorts.
CONCLUSIONS


PF-06480605 was generally well tolerated, and binding of soluble TL1A was maintained throughout the dose interval, supporting further study of PF-06480605 in patients with IBD and other inflammatory conditions.",2020,"Target engagement was demonstrated through dose-dependent differences in serum total soluble TL1A concentrations for PF-06480605 vs placebo cohorts.
","['Ninety-two subjects', 'patients with IBD and other inflammatory conditions', 'healthy subjects', 'healthy subjects (NCT01989143']","['single ascending doses (SAD): PF-06480605', 'placebo', 'PF-06480605 SAD', 'MAD']","['tolerated', 'deaths or serious adverse events', 'safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity', 'safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of intravenous (IV) and subcutaneous (SC) PF-06480605', 'ADA and NAb levels', 'Safety, tolerability, pharmacokinetics, immunogenicity profiles, and total TL1A, anti-drug antibody (ADA), and neutralizing antibody (NAb) levels', 'serum total soluble TL1A concentrations', 'tolerated, and binding of soluble TL1A']","[{'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory Bowel Diseases'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0671759', 'cui_str': 'MAD'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C1142254', 'cui_str': 'Neutralising antibodies'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",92.0,0.0433972,"Target engagement was demonstrated through dose-dependent differences in serum total soluble TL1A concentrations for PF-06480605 vs placebo cohorts.
","[{'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Banfield', 'Affiliation': 'Pfizer Inc, Cambridge, Massachusetts.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Rudin', 'Affiliation': 'Pfizer Inc, New Haven, Connecticut.'}, {'ForeName': 'Indranil', 'Initials': 'I', 'LastName': 'Bhattacharya', 'Affiliation': 'Pfizer Inc, Cambridge, Massachusetts.'}, {'ForeName': 'Kosalaram', 'Initials': 'K', 'LastName': 'Goteti', 'Affiliation': 'Pfizer Inc, Cambridge, Massachusetts.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': 'Pfizer Inc, Collegeville, Pennsylvania.'}, {'ForeName': 'Mina', 'Initials': 'M', 'LastName': 'Hassan-Zahraee', 'Affiliation': 'Pfizer Inc, Cambridge, Massachusetts.'}, {'ForeName': 'Lisa S', 'Initials': 'LS', 'LastName': 'Brown', 'Affiliation': 'Pfizer Inc, Collegeville, Pennsylvania.'}, {'ForeName': 'Kenneth E', 'Initials': 'KE', 'LastName': 'Hung', 'Affiliation': 'Pfizer Inc, Cambridge, Massachusetts.'}, {'ForeName': 'Sylvester', 'Initials': 'S', 'LastName': 'Pawlak', 'Affiliation': 'Pfizer Inc, New Haven, Connecticut.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Lepsy', 'Affiliation': 'Pfizer Inc, Andover, Massachusetts.'}]",British journal of clinical pharmacology,['10.1111/bcp.14187']
260,31858673,Benefits of insulin degludec/liraglutide are maintained even in patients discontinuing sulphonylureas or dipeptidyl peptidase-4 inhibitors upon initiation of degludec/liraglutide therapy: A post hoc analysis of the DUAL II and DUAL IX trials.,"AIM


To investigate the efficacy and safety of initiating insulin degludec/liraglutide (IDegLira) in patients with type 2 diabetes (T2D) who had discontinued pretrial sulphonylureas (SUs) or dipeptidyl peptidase-4 inhibitors (DPP4is) versus patients not previously treated with these regimens.
MATERIALS AND METHODS


In DUAL II, patients with T2D uncontrolled on basal insulin and metformin ± SU/glinides were randomized to insulin degludec or IDegLira (both capped at 50 U). In DUAL IX, patients were randomized to insulin glargine U100 (no maximum dose) or IDegLira, as add-on to sodium-glucose co-transporter-2 inhibitors ± oral antidiabetic drugs. In this post hoc analysis, patients were grouped according to pretrial use of SU (DUAL II) or DPP4i (DUAL IX).
RESULTS


Regardless of pretrial SU/DPP4i use, IDegLira was favourable versus insulin comparators with respect to change in HbA1c and body weight. Lower hypoglycaemia rates and comparable end-of-trial daily insulin dose were achieved with IDegLira, regardless of pretrial regimen. There was no clinically relevant increase in mean self-measured blood glucose in the early weeks after IDegLira initiation. There was no statistically significant interaction between the randomized treatments and previous SU/DPP4i use.
CONCLUSIONS


IDegLira was more favourable compared with degludec or glargine U100 in terms of change in HbA1c and body weight, regardless of antecedent treatment. Clinicians should be aware of a potential transient rise in self-measured blood glucose when transitioning therapy in patients. This shows that SUs/DPP4is can be safely discontinued, without deterioration in glycaemic control when initiating IDegLira, allowing a simplified treatment regimen.",2020,"Lower hypoglycaemia rates and comparable end-of-trial daily insulin dose were achieved with IDegLira, regardless of pre-trial regimen.","['patients currently using SUs or DPP4is', 'patients with type 2 diabetes (T2D) that had discontinued pre-trial sulphonylurea (SU) or dipeptidyl peptidase-4 inhibitors (DPP4is) vs patients not previously treated with these regimens', 'patients discontinuing sulphonylurea or dipeptidyl peptidase-4 inhibitor upon initiation of IDegLira therapy', 'patients with T2D uncontrolled on basal insulin and metformin ± SU/glinides']","['insulin glargine U100 (no maximum dose) or IDegLira, as add-on to sodium-glucose co-transporter-2 inhibitors ± oral antidiabetic drugs', 'DUAL II and DUAL', 'SU (DUAL II) or DPP4i (DUAL IX', 'glargine', 'insulin degludec/liraglutide (IDegLira']","['Lower hypoglycaemia rates', 'mean self-measured blood glucose']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1706472', 'cui_str': 'Discontinue - dosing instruction imperative'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C1827106', 'cui_str': 'Dipeptidyl-Peptidase 4 Inhibitors'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C4308663', 'cui_str': 'IDegLira'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled (qualifier value)'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4308663', 'cui_str': 'IDegLira'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C4301634', 'cui_str': 'Sodium-glucose co-transporter 2 (SGLT2) inhibitors'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0935929', 'cui_str': 'Antidiabetics'}, {'cui': 'C4059165', 'cui_str': 'insulin degludec / liraglutide'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}]",,0.0406693,"Lower hypoglycaemia rates and comparable end-of-trial daily insulin dose were achieved with IDegLira, regardless of pre-trial regimen.","[{'ForeName': 'Andrej', 'Initials': 'A', 'LastName': 'Janez', 'Affiliation': 'University Medical Centre Ljubljana, Ljubljana, Slovenia.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Őrsy', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Karolina', 'Initials': 'K', 'LastName': 'Stachlewska', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Salvesen-Sykes', 'Affiliation': 'Novo Nordisk Inc., Plainsboro, New, Jersey.'}, {'ForeName': 'Liana K', 'Initials': 'LK', 'LastName': 'Billings', 'Affiliation': 'NorthShore University Health System/University of Chicago Pritzker School of Medicine, Skokie, Illinois.'}, {'ForeName': 'Athena', 'Initials': 'A', 'LastName': 'Philis-Tsimikas', 'Affiliation': 'Scripps Whittier Diabetes Institute, San Diego, California.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13944']
261,31858718,Low-dose empagliflozin as adjunct-to-insulin therapy in type 1 diabetes: A valid modelling and simulation analysis to confirm efficacy.,"AIM


To confirm the observed reduction in HbA1c for the 2.5 mg dose in EASE-3 by modelling and simulation analyses.
MATERIALS AND METHODS


Independent of data from EASE-3 that tested 2.5 mg, we simulated the effect of a 2.5 mg dose through patient-level, exposure-response modelling in the EASE-2 clinical study. A primary semi-mechanistic model evaluated efficacy considering clinical insulin dose adjustments made after treatment initiation that potentially limited HbA1c reductions. The model was informed by pharmacokinetic, insulin dose, mean daily glucose and HbA1c data, and was verified by comparing the simulations with the observed HbA1c change in EASE-3. One of two empagliflozin phase 3 trials in type 1 diabetes (EASE-3 but not EASE-2) included a lower 2.5 mg dose. A placebo-corrected HbA1c reduction of 0.28% was demonstrated without the increased risk of diabetic ketoacidosis observed at higher doses (10 mg and 25 mg). Since only one trial included the lower dose, we aimed to confirm the observed reduction in HbA1c for the 2.5 mg dose by modelling and simulation analyses.
RESULTS


The simulated 26-week mean HbA1c change was -0.41% without insulin dose adjustment and -0.29% at 26 weeks with insulin dose adjustment. A simplified (descriptive) model excluding insulin dose and mean daily glucose confirmed the -0.29% HbA1c change that would have been observed had the EASE-2 population received a 2.5 mg dose for 26/52 weeks.
CONCLUSIONS


The HbA1c benefit of low-dose empagliflozin directly observed in the EASE-3 trial was confirmed by two modelling and simulation approaches.",2020,A placebo-corrected HbA1c reduction 0.28% was demonstrated without the increased risk of diabetic ketoacidosis observed at higher doses (10 mg and 25 mg).,['Type 1 Diabetes'],"['placebo', 'Low-Dose Empagliflozin', 'empagliflozin']",['risk of diabetic ketoacidosis'],"[{'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0011880', 'cui_str': 'Ketosis, Diabetic'}]",,0.0720085,A placebo-corrected HbA1c reduction 0.28% was demonstrated without the increased risk of diabetic ketoacidosis observed at higher doses (10 mg and 25 mg).,"[{'ForeName': 'Bruce A', 'Initials': 'BA', 'LastName': 'Perkins', 'Affiliation': 'Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'Nima', 'Initials': 'N', 'LastName': 'Soleymanlou', 'Affiliation': 'Boehringer Ingelheim Canada Ltd, Burlington, Ontario, Canada.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Rosenstock', 'Affiliation': 'Dallas Diabetes Research Center at Medical City, Dallas, Texas, United States.'}, {'ForeName': 'Jay S', 'Initials': 'JS', 'LastName': 'Skyler', 'Affiliation': 'Diabetes Research Institute, University of Miami Miller School of Medicine, Miami, Florida, United States.'}, {'ForeName': 'Lori M', 'Initials': 'LM', 'LastName': 'Laffel', 'Affiliation': 'Joslin Diabetes Center, Harvard Medical School, Boston, Massachusetts, United States.'}, {'ForeName': 'Karl-Heinz', 'Initials': 'KH', 'LastName': 'Liesenfeld', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co KG, Biberach, Germany.'}, {'ForeName': 'Dietmar', 'Initials': 'D', 'LastName': 'Neubacher', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co KG, Biberach, Germany.'}, {'ForeName': 'Matthew M', 'Initials': 'MM', 'LastName': 'Riggs', 'Affiliation': 'Metrum Research Group, Tariffville, Connecticut, United States.'}, {'ForeName': 'Curtis K', 'Initials': 'CK', 'LastName': 'Johnston', 'Affiliation': 'Metrum Research Group, Tariffville, Connecticut, United States.'}, {'ForeName': 'Rena J', 'Initials': 'RJ', 'LastName': 'Eudy-Byrne', 'Affiliation': 'Metrum Research Group, Tariffville, Connecticut, United States.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Elmokadem', 'Affiliation': 'Metrum Research Group, Tariffville, Connecticut, United States.'}, {'ForeName': 'Jyothis T', 'Initials': 'JT', 'LastName': 'George', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Marquard', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Nock', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co KG, Biberach, Germany.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13945']
262,31865633,Human regular U-500 insulin via continuous subcutaneous insulin infusion versus multiple daily injections in adults with type 2 diabetes: The VIVID study.,"AIM


To compare the safety and efficacy of U500-R delivered by a novel, specifically designed U500-R insulin pump with U-500R delivered by multiple daily injections (MDI).
METHODS


The phase 3 VIVID study randomized people with type 2 diabetes to U-500R by continuous subcutaneous insulin infusion (CSII) or MDI. Participants (aged 18-85 years) had HbA1c ≥7.5% and ≤12.0% and a total daily dose of insulin >200 and ≤600 U/day. After a 2-week transition to three times daily injections of U-500R, participants were treated for 24 weeks with U-500R by CSII or MDI. Treatment arms were compared using mixed model repeated measures analysis.
RESULTS


The study randomized 420 participants (CSII: 209, MDI: 211) with 365 completers. Mean changes from baseline were: HbA1c, -1.27% (-13.9 mmol/mol) with CSII and -0.85% (-9.3 mmol/mol) with MDI (difference - 0.42% [-4.6 mmol/mol], P <0.001); fasting plasma glucose, -33.9 mg/dL (-1.9 mmol/L) with CSII and 1.7 mg/dL (0.09 mmol/L) with MDI (difference - 35.6 mg/dL [-2.0 mmol/L], P <0.001); total daily dose, 2.8 U with CSII and 51.3 U with MDI (P < 0.001). Weight changes and rates of documented symptomatic and severe hypoglycaemia were similar between groups; the CSII group had a higher rate of nocturnal hypoglycaemia.
CONCLUSIONS


In type 2 diabetes requiring high doses of insulin, both methods of U-500R delivery lowered HbA1c. However, the CSII group attained greater HbA1c reduction with significantly less insulin. Individualized dose titration will be important to balance glycaemic control with hypoglycaemia risk.",2020,"Weight changes and rates of documented symptomatic and severe hypoglycemia were similar between groups; the CSII group had a higher rate of nocturnal hypoglycemia.
","['The Phase 3 VIVID study randomized people with type 2 diabetes to U-500R by CSII or MDI', 'Adults with Type 2 Diabetes', '420 participants (CSII: 209, MDI: 211) with 365 completers', 'people with diabetes requiring high dose insulin', 'Participants (aged 18-85\u2009years) had A1C ≥7.5% and ≤12.0% and total daily dose (TDD) of insulin']","['CSII', 'Human Regular U-500 Insulin via Continuous Subcutaneous Insulin Infusion vs. Multiple Daily Injections']","['fasting plasma glucose', 'A1C reduction', 'nocturnal hypoglycemia', 'safety and efficacy', 'Weight changes and rates of documented symptomatic and severe hypoglycemia']","[{'cui': 'C0439561', 'cui_str': 'Phase 3 (qualifier value)'}, {'cui': 'C1268943', 'cui_str': 'Vivid'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0993596', 'cui_str': 'Metered Dose Inhaler'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517774', 'cui_str': 'Four hundred and twenty'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0342315', 'cui_str': 'Nocturnal hypoglycemia (disorder)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}]",420.0,0.0568893,"Weight changes and rates of documented symptomatic and severe hypoglycemia were similar between groups; the CSII group had a higher rate of nocturnal hypoglycemia.
","[{'ForeName': 'George', 'Initials': 'G', 'LastName': 'Grunberger', 'Affiliation': 'Grunberger Diabetes Institute, Bloomfield Hills, Michigan, United States.'}, {'ForeName': 'Anuj', 'Initials': 'A', 'LastName': 'Bhargava', 'Affiliation': 'Iowa Diabetes and Endocrinology Research Center, West Des Moines, Iowa, United States.'}, {'ForeName': 'Trang', 'Initials': 'T', 'LastName': 'Ly', 'Affiliation': 'Insulet Corporation, 100 Nagog Park, Acton, Massachusetts, United States.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Zisser', 'Affiliation': 'Verily Life Sciences, San Francisco, California, United States.'}, {'ForeName': 'Liza L', 'Initials': 'LL', 'LastName': 'Ilag', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, United States.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Malone', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, United States.'}, {'ForeName': 'Ludi', 'Initials': 'L', 'LastName': 'Fan', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, United States.'}, {'ForeName': 'Shuyu', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, United States.'}, {'ForeName': 'Jennal', 'Initials': 'J', 'LastName': 'Johnson', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, United States.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13947']
263,31903692,Semaglutide (SUSTAIN and PIONEER) reduces cardiovascular events in type 2 diabetes across varying cardiovascular risk.,"AIM


To investigate the effects of semaglutide versus comparators on major adverse cardiovascular events (MACE: cardiovascular [CV] death, nonfatal myocardial infarction [MI] and nonfatal stroke) and hospitalization for heart failure (HF) in the SUSTAIN (subcutaneous semaglutide) and PIONEER (oral semaglutide) trials across subgroups of varying CV risk.
METHODS


Post hoc analyses of individual patient-level data combined from SUSTAIN 6 and PIONEER 6 were performed to assess MACE and HF. MACE were analysed in subjects with and without: established CV disease and/or chronic kidney disease; prior MI or stroke; and prior HF. MACE in the SUSTAIN and PIONEER glycaemic efficacy trials were also assessed.
RESULTS


In SUSTAIN 6 and PIONEER 6 combined, the hazard ratio (HR) for effect of semaglutide versus placebo on overall MACE was 0.76 (95% CI 0.62, 0.92), which was mainly driven by the effect on nonfatal stroke (HR 0.65 [95% CI 0.43, 0.97]). The HR for hospitalization for HF was 1.03 (95% CI 0.75, 1.40). The HRs for MACE were <1.0 in all subgroups, except for those with prior HF (HR 1.06 [95% CI 0.72, 1.57]); P-values for interaction of subgroup on treatment effect were >0.05, except for HF (0.046). In the combined glycaemic efficacy trials, the HR for effect of semaglutide versus comparators on MACE was 0.85 (95% CI 0.55, 1.33).
CONCLUSIONS


In SUSTAIN and PIONEER combined, glucagon-like peptide-1 analogue semaglutide showed consistent effects on MACE versus comparators across varying CV risk. No effect of semaglutide on MACE was observed in subjects with prior HF.",2020,"The HRs for MACE were <1.0 in all subgroups, except for those with prior HF (HR 1.06 [95% CI 0.72, 1.57]); P-values for interaction of subgroup on treatment effect were >0.05, except for HF (0.046).","['subgroups of varying CV risk', 'subjects with prior HF', 'subjects with and without: established CV disease and/or chronic kidney disease; prior MI or stroke; and prior HF']","['MACE and HF', 'placebo', 'MACE']","['hazard ratio (HR', 'nonfatal stroke', 'cardiovascular events', 'major adverse cardiovascular events (MACE: cardiovascular [CV] death, nonfatal myocardial infarction [MI] and nonfatal stroke) and hospitalization for heart failure (HF', 'HR for hospitalization for HF', 'overall MACE']","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}]","[{'cui': 'C0349381', 'cui_str': 'Mace (substance)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0349381', 'cui_str': 'Mace (substance)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.148452,"The HRs for MACE were <1.0 in all subgroups, except for those with prior HF (HR 1.06 [95% CI 0.72, 1.57]); P-values for interaction of subgroup on treatment effect were >0.05, except for HF (0.046).","[{'ForeName': 'Mansoor', 'Initials': 'M', 'LastName': 'Husain', 'Affiliation': 'Ted Rogers Centre for Heart Research, Toronto General Hospital Research Institute, Toronto, Canada.'}, {'ForeName': 'Stephen C', 'Initials': 'SC', 'LastName': 'Bain', 'Affiliation': 'Swansea University Medical School, Diabetes Research Unit Cymru, Swansea, UK.'}, {'ForeName': 'Ole K', 'Initials': 'OK', 'LastName': 'Jeppesen', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Ildiko', 'Initials': 'I', 'LastName': 'Lingvay', 'Affiliation': 'UT Southwestern Medical Center, Internal Medicine and Population and Data Sciences, Dallas, Texas.'}, {'ForeName': 'Rasmus', 'Initials': 'R', 'LastName': 'Sørrig', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Marianne B', 'Initials': 'MB', 'LastName': 'Treppendahl', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Vilsbøll', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13955']
264,32208178,Utilizing Community Engagement Studios to inform patient experience in a multicenter randomized control trial.,"OBJECTIVE


To determine whether a community engagement approach can provide feedback for implementation of valuable measures to improve the outcome of a clinical trial.
METHODS


Review of the results from a Community Engagement Studio (CE Studio) for the ValEAR trial: an NIH-funded, multi-institutional study designed to research the efficacy of valganciclovir in the treatment of congenital cytomegalovirus (cCMV)-induced hearing loss. Participants were given information about the trial then asked a series of questions to assess their input on the merits or weaknesses affecting their participation in the trial.
RESULTS


Thirteen parents whose children have congenital CMV infection were recruited for the CE Studio. The overall theme from the responses was a desire to advance the field but a need to clearly understand the risks and benefits of participation. Many requested more educational resources, more printed materials, or greater access to researchers if questions arose. Many welcomed having patient stories and information displayed in a dedicated website or through social media.
CONCLUSION


This community engagement approach provided useful feedback from families similar to those expected to be potential enrollees in the CMV ValEAR trial. In response to parental comments, two educational videos were created: one on the general topic of cCMV and the other specific to the CMV ValEAR trial. Researchers who wish to optimize their clinical trial's success should consider incorporating a CE Studio into their study design.",2020,This community engagement approach provided useful feedback from families similar to those expected to be potential enrollees in the CMV ValEAR trial.,"['congenital cytomegalovirus (cCMV)-induced hearing loss', 'Thirteen parents whose children have congenital CMV infection were recruited for the CE Studio']","['Community Engagement Studio (CE Studio', 'valganciclovir']",[],"[{'cui': 'C1744681', 'cui_str': 'Congenital (qualifier value)'}, {'cui': 'C0010825', 'cui_str': 'Salivary Gland Viruses'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0158945', 'cui_str': 'Congenital cytomegalovirus infection (disorder)'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0909381', 'cui_str': 'valganciclovir'}]",[],13.0,0.130066,This community engagement approach provided useful feedback from families similar to those expected to be potential enrollees in the CMV ValEAR trial.,"[{'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Nielson', 'Affiliation': 'Division of Otolaryngology - Head and Neck Surgery, University of Utah School of Medicine, Salt Lake City, UT, USA.'}, {'ForeName': 'Yiqing', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Division of Otolaryngology - Head and Neck Surgery, University of Utah School of Medicine, Salt Lake City, UT, USA.'}, {'ForeName': 'C Amanda', 'Initials': 'CA', 'LastName': 'Kull', 'Affiliation': 'Division of Otolaryngology - Head and Neck Surgery, University of Utah School of Medicine, Salt Lake City, UT, USA.'}, {'ForeName': 'Albert H', 'Initials': 'AH', 'LastName': 'Park', 'Affiliation': 'Division of Otolaryngology - Head and Neck Surgery, University of Utah School of Medicine, Salt Lake City, UT, USA. Electronic address: Albert.Park@hsc.utah.edu.'}]",International journal of pediatric otorhinolaryngology,['10.1016/j.ijporl.2020.110007']
265,32020400,"Microwave ablation plus chemotherapy versus chemotherapy in advanced non-small cell lung cancer: a multicenter, randomized, controlled, phase III clinical trial.","OBJECTIVES


This prospective trial was performed to verify whether microwave ablation (MWA) in combination with chemotherapy could provide superior survival benefit compared with chemotherapy alone.
MATERIALS AND METHODS


From March 1, 2015, to June 20, 2017, treatment-naïve patients with pathologically verified advanced or recurrent non-small cell lung cancer (NSCLC) were randomly assigned to MWA plus chemotherapy group or chemotherapy group. The primary endpoint was progression-free survival (PFS), while the secondary endpoints included overall survival (OS), time to local progression (TTLP), and objective response rate (ORR). The complications and adverse events were also reported.
RESULTS


A total of 293 patients were randomly assigned into the two groups. One hundred forty-eight patients with 117 stage IV tumors were included in the MWA plus chemotherapy group. One hundred forty-five patients with 113 stage IV tumors were included in the chemotherapy group. The median follow-up period was 13.1 months and 12.4 months, respectively. Median PFS was 10.3 months (95% CI 8.0-13.0) in the MWA plus chemotherapy group and 4.9 months (95% CI 4.2-5.7) in the chemotherapy group (HR = 0.44, 95% CI 0.28-0.53; p < 0.0001). Median OS was not reached in the MWA plus chemotherapy group and 12.6 months (95% CI 10.6-14.6) in the chemotherapy group (HR = 0.38, 95% CI 0.27-0.53; p < 0.0001) using Kaplan-Meier analyses with log-rank test. The median TTLP was 24.5 months, and the ORR was 32% in both groups. The adverse event rate was not significantly different in the two groups.
CONCLUSIONS


In patients with advanced NSCLC, longer PFS and OS can be achieved with the treatment of combined MWA and chemotherapy than chemotherapy alone.
KEY POINTS


• Patients treated with MWA plus chemotherapy had superior PFS and OS over those treated with chemotherapy alone. • The ORR of patients treated with MWA plus chemotherapy was similar to that of those treated with chemotherapy alone. • Complications associated with MWA were common but tolerable and manageable.",2020,"Median PFS was 10.3 months (95% CI 8.0-13.0) in the MWA plus chemotherapy group and 4.9 months (95% CI 4.2-5.7) in the chemotherapy group (HR = 0.44, 95% CI 0.28-0.53; p < 0.0001).","['From March 1, 2015, to June 20, 2017, treatment-naïve patients with pathologically verified advanced or recurrent non-small cell lung cancer (NSCLC', 'One hundred forty-eight patients with 117 stage IV tumors were included in the MWA plus chemotherapy group', 'advanced non-small cell lung cancer', 'A total of 293 patients', 'One hundred forty-five patients with 113 stage IV tumors were included in the chemotherapy group']","['chemotherapy', 'MWA plus chemotherapy group or chemotherapy', 'microwave ablation (MWA', 'Microwave ablation plus chemotherapy versus chemotherapy', 'MWA plus chemotherapy']","['overall survival (OS), time to local progression (TTLP), and objective response rate (ORR', 'progression-free survival (PFS', 'median TTLP', 'Median PFS', 'complications and adverse events', 'superior PFS and OS', 'Median OS', 'adverse event rate', 'ORR']","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4319608', 'cui_str': 'Forty-eight'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4 (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4319567', 'cui_str': '45'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C3854551', 'cui_str': 'Microwave ablation'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}]",293.0,0.295302,"Median PFS was 10.3 months (95% CI 8.0-13.0) in the MWA plus chemotherapy group and 4.9 months (95% CI 4.2-5.7) in the chemotherapy group (HR = 0.44, 95% CI 0.28-0.53; p < 0.0001).","[{'ForeName': 'Zhigang', 'Initials': 'Z', 'LastName': 'Wei', 'Affiliation': 'Department of Oncology, Shandong Provincial Hospital Affiliated to Shandong University, 324 Jingwuweiqi Road, Jinan, Shandong Province, China.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Department of Oncology, Shandong Provincial Hospital Affiliated to Shandong University, 324 Jingwuweiqi Road, Jinan, Shandong Province, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Ye', 'Affiliation': 'Department of Oncology, Shandong Provincial Hospital Affiliated to Shandong University, 324 Jingwuweiqi Road, Jinan, Shandong Province, China. yexintaian2014@163.com.'}, {'ForeName': 'Qingliang', 'Initials': 'Q', 'LastName': 'Feng', 'Affiliation': 'Department of Oncology, Liaocheng Cancer Hospital, Liaocheng, Shandong, China.'}, {'ForeName': 'Yanjun', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Department of Oncology, Liaocheng Cancer Hospital, Liaocheng, Shandong, China.'}, {'ForeName': 'Licheng', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': ""Department of Oncology, The People's Liberation Army 88 Hospital, Tai'an, Shandong, China.""}, {'ForeName': 'Wenqiao', 'Initials': 'W', 'LastName': 'Sun', 'Affiliation': ""Department of Oncology, The People's Liberation Army 88 Hospital, Tai'an, Shandong, China.""}, {'ForeName': 'Yuting', 'Initials': 'Y', 'LastName': 'Dong', 'Affiliation': ""Department of Oncology, Dezhou People's Hospital, Dezhou, Shandong, China.""}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Meng', 'Affiliation': ""Department of Oncology, Dezhou People's Hospital, Dezhou, Shandong, China.""}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': ""Department of Oncology, Dezhou People's Hospital, Dezhou, Shandong, China.""}, {'ForeName': 'Chuntang', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': ""Department of Thoracic Surgery, The Second People's Hospital of Dezhou, Dezhou, Shandong, China.""}, {'ForeName': 'Guangxu', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': ""Department of Thoracic Surgery, The Second People's Hospital of Dezhou, Dezhou, Shandong, China.""}, {'ForeName': 'Kaixian', 'Initials': 'K', 'LastName': 'Zhang', 'Affiliation': ""Department of Oncology, Tengzhou Central People's Hospital, Zaozhuang, Shandong, China.""}, {'ForeName': 'Peishun', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': ""Department of Oncology, Tengzhou Central People's Hospital, Zaozhuang, Shandong, China.""}, {'ForeName': 'Jingwang', 'Initials': 'J', 'LastName': 'Bi', 'Affiliation': 'Department of Oncology, Jinan Military General Hospital, Jinan, Shandong, China.'}, {'ForeName': 'Guoliang', 'Initials': 'G', 'LastName': 'Xue', 'Affiliation': 'Department of Oncology, Jinan Military General Hospital, Jinan, Shandong, China.'}, {'ForeName': 'Yahong', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Department of Oncology, Affiliated Hospital of Shandong Academy of Medical Sciences, Jinan, Shandong, China.'}, {'ForeName': 'Lijun', 'Initials': 'L', 'LastName': 'Sheng', 'Affiliation': 'Department of Oncology, Liaocheng Cancer Hospital, Liaocheng, Shandong, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': 'Department of Oncology, Affiliated Hospital of Shandong Academy of Medical Sciences, Jinan, Shandong, China.'}, {'ForeName': 'Guohua', 'Initials': 'G', 'LastName': 'Yu', 'Affiliation': ""Department of Oncology, Weifang People's Hospital, Weifang, Shandong, China.""}, {'ForeName': 'Haipeng', 'Initials': 'H', 'LastName': 'Ren', 'Affiliation': ""Department of Oncology, Weifang People's Hospital, Weifang, Shandong, China.""}, {'ForeName': 'Junye', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Oncology, Affiliated Hospital of Jining Medical University, Jining, Shandong, China.'}, {'ForeName': 'Lijun', 'Initials': 'L', 'LastName': 'Sun', 'Affiliation': 'Department of Oncology, Affiliated Hospital of Jining Medical University, Jining, Shandong, China.'}, {'ForeName': 'Shaoshui', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Department of Oncology, Binzhou Medical University Hospital, Binzhou, Shandong, China.'}, {'ForeName': 'Dianzhong', 'Initials': 'D', 'LastName': 'Geng', 'Affiliation': 'Department of Oncology, Binzhou Medical University Hospital, Binzhou, Shandong, China.'}, {'ForeName': 'Benhua', 'Initials': 'B', 'LastName': 'Zhang', 'Affiliation': ""Department of Oncology, Affiliated Hospital of Taishan Medical University, Tai'an, Shandong, China.""}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': ""Department of Oncology, Affiliated Hospital of Taishan Medical University, Tai'an, Shandong, China.""}, {'ForeName': 'Liangming', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Oncology, Yantai Yuhuangding Hospital, Yantai, Shandong, China.'}, {'ForeName': 'Dengjun', 'Initials': 'D', 'LastName': 'Sun', 'Affiliation': 'Department of Oncology, Yantai Yuhuangding Hospital, Yantai, Shandong, China.'}, {'ForeName': 'Xinglu', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': ""Department of Oncology, The People's Hospital of Pingyi Country, Linyi, Shandong, China.""}, {'ForeName': 'Cunqi', 'Initials': 'C', 'LastName': 'Diao', 'Affiliation': ""Department of Oncology, The People's Hospital of Pingyi Country, Linyi, Shandong, China.""}, {'ForeName': 'Guanghui', 'Initials': 'G', 'LastName': 'Huang', 'Affiliation': 'Department of Oncology, Shandong Provincial Hospital Affiliated to Shandong University, 324 Jingwuweiqi Road, Jinan, Shandong Province, China.'}, {'ForeName': 'Wenhong', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Oncology, Shandong Provincial Hospital Affiliated to Shandong University, 324 Jingwuweiqi Road, Jinan, Shandong Province, China.'}, {'ForeName': 'Xiaoying', 'Initials': 'X', 'LastName': 'Han', 'Affiliation': 'Department of Oncology, Shandong Provincial Hospital Affiliated to Shandong University, 324 Jingwuweiqi Road, Jinan, Shandong Province, China.'}, {'ForeName': 'Jiao', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Oncology, Shandong Provincial Hospital Affiliated to Shandong University, 324 Jingwuweiqi Road, Jinan, Shandong Province, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Meng', 'Affiliation': 'Department of Oncology, Shandong Provincial Hospital Affiliated to Shandong University, 324 Jingwuweiqi Road, Jinan, Shandong Province, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Ni', 'Affiliation': 'Department of Oncology, Shandong Provincial Hospital Affiliated to Shandong University, 324 Jingwuweiqi Road, Jinan, Shandong Province, China.'}, {'ForeName': 'Aimin', 'Initials': 'A', 'LastName': 'Zheng', 'Affiliation': 'Department of Oncology, Shandong Provincial Hospital Affiliated to Shandong University, 324 Jingwuweiqi Road, Jinan, Shandong Province, China.'}, {'ForeName': 'Weijun', 'Initials': 'W', 'LastName': 'Fan', 'Affiliation': 'Department of Imaging and Interventional Radiology, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China.'}, {'ForeName': 'Yuliang', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Interventional Medicine, The Second Hospital of Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': ""Department of Health Statistics, School of Preventive Medicine, Fourth Military Medical University, Xi'an, Shanxi, China.""}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Fan', 'Affiliation': ""Public Health School, Taishan Medical University, Tai'an, Shandong, China.""}, {'ForeName': 'Zhigeng', 'Initials': 'Z', 'LastName': 'Zou', 'Affiliation': 'Department of Oncology, Shandong Provincial Hospital Affiliated to Shandong University, 324 Jingwuweiqi Road, Jinan, Shandong Province, China.'}, {'ForeName': 'Qingyu', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Oncology, Shandong Provincial Hospital Affiliated to Shandong University, 324 Jingwuweiqi Road, Jinan, Shandong Province, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Tian', 'Affiliation': 'Department of Oncology, Shandong Provincial Hospital Affiliated to Shandong University, 324 Jingwuweiqi Road, Jinan, Shandong Province, China.'}]",European radiology,['10.1007/s00330-019-06613-x']
266,31486777,Magnetic seizure therapy (MST) for major depressive disorder.,"Electroconvulsive therapy (ECT) is effective for major depressive disorder (MDD) but its effects on memory limit its widespread use. Magnetic seizure therapy (MST) is a potential alternative to ECT that may not adversely affect memory. In the current trial, consecutive patients with MDD consented to receive MST applied over the prefrontal cortex according to an open-label protocol. Depressive symptoms and cognition were assessed prior to, during and at the end of treatment. Patients were treated two to three times per week with high-frequency MST (i.e., 100 Hz) (N = 24), medium frequency MST (i.e., 60 or 50 Hz) (N = 26), or low-frequency MST (i.e., 25 Hz MST) (N = 36) using 100% stimulator output. One hundred and forty patients were screened; 86 patients with MDD received a minimum of eight treatments and were deemed to have an adequate course of MST; and 47 completed the trial per protocol, either achieving remission (i.e., 24-item Hamilton Rating Scale for Depression score <10 and a relative reduction of >60% at two consecutive assessments; n = 17) or received a maximum of 24 sessions (n = 30). High-frequency (100 Hz) MST produced the highest remission rate (33.3%). Performance on most cognitive measures remained stable, with the exception of significantly worsened recall consistency of autobiographical information and significantly improved brief visuospatial memory task performance. Under open conditions, MST led to clinically meaningful reduction in depressive symptoms in patients with MDD and produced minimal cognitive impairment. Future studies should compare MST and ECT under double-blind randomized condition.",2020,"Performance on most cognitive measures remained stable, with the exception of significantly worsened recall consistency of autobiographical information and significantly improved brief visuospatial memory task performance.","['consecutive patients with MDD consented to receive', 'major depressive disorder', 'One hundred and forty patients were screened; 86 patients with MDD received a minimum of eight treatments and were deemed to have an adequate course of MST; and 47 completed the trial per protocol, either achieving remission (i.e., 24-item Hamilton Rating Scale for Depression score <10 and a relative reduction of >60% at two consecutive assessments; n\u2009=\u200917) or received a maximum of 24 sessions (n\u2009=\u200930']","['Magnetic seizure therapy (MST', 'Electroconvulsive therapy (ECT', 'MST']","['depressive symptoms', 'High-frequency', 'Depressive symptoms and cognition', 'minimal cognitive impairment', 'highest remission rate', 'brief visuospatial memory task performance']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C4545802', 'cui_str': 'HAM-D (Hamilton Rating Scale for Depression) score'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C0024488', 'cui_str': 'Magnetics'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0013806', 'cui_str': 'Electroshock Therapy'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0205212', 'cui_str': 'High frequency (qualifier value)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C1291708', 'cui_str': 'Minimal cognitive impairment'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}]",140.0,0.0334955,"Performance on most cognitive measures remained stable, with the exception of significantly worsened recall consistency of autobiographical information and significantly improved brief visuospatial memory task performance.","[{'ForeName': 'Zafiris J', 'Initials': 'ZJ', 'LastName': 'Daskalakis', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada. Jeff.Daskalakis@camh.ca.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Dimitrova', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Shawn M', 'Initials': 'SM', 'LastName': 'McClintock', 'Affiliation': 'Neurocognitive Research Laboratory, Department of Psychiatry, University of Texas Southwestern Medical Center, and Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Yinming', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Daphne', 'Initials': 'D', 'LastName': 'Voineskos', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Tarek K', 'Initials': 'TK', 'LastName': 'Rajji', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Goldbloom', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Albert H C', 'Initials': 'AHC', 'LastName': 'Wong', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Yuliya', 'Initials': 'Y', 'LastName': 'Knyahnytska', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Benoit H', 'Initials': 'BH', 'LastName': 'Mulsant', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Downar', 'Affiliation': 'Toronto General Hospital, University Health Network, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Paul B', 'Initials': 'PB', 'LastName': 'Fitzgerald', 'Affiliation': 'Epworth Centre for Innovation in Mental Health, Epworth Healthcare and Monash Alfred Psychiatry Research Centre, The Alfred and Monash University Central Clinical School, Commercial Rd Melbourne, VIC, Australia.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Blumberger', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0515-4']
267,31729107,Clinical outcomes with canagliflozin according to baseline body mass index: results from post hoc analyses of the CANVAS Program.,"AIMS


Sodium glucose co-transporter 2 (SGLT2) inhibitors reduce several cardiovascular risk factors, including plasma glucose, blood pressure, albuminuria and body weight. Long-term treatment lowers risks of cardiovascular and renal events. The objective of this post hoc analysis was to determine the effects of canagliflozin treatment versus placebo on clinical outcomes in relation to body mass index (BMI).
MATERIALS AND METHODS


The CANVAS Program randomized 10 142 participants with type 2 diabetes to canagliflozin or placebo. These analyses tested the consistency of canagliflozin treatment effects across BMI levels for cardiovascular, renal, safety and body weight outcomes in three groups defined by baseline BMI: <25, 25-<30 and ≥30 kg/m 2  .
RESULTS


In total, 10 128 participants with baseline BMI measurements were included. There were 966 participants with BMI <25 kg/m 2  , 3153 with BMI 25-<30 kg/m 2  and 6009 with BMI ≥30 kg/m 2  . Mean percent body weight reduction with canagliflozin compared with placebo was greater at 12 months [-2.77%  (95% confidence interval (CI): -2.95, -2.59)] than at 3 months [-1.72%  (95% CI: -1.83, -1.62)]. The hazard ratios (HRs) for canagliflozin compared with placebo control for the composite outcome of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke were 1.03 (95% CI: 0.66, 1.59) in participants with BMI <25 kg/m 2  , 0.97 (0.76, 1.23) with BMI 25-<30 kg/m 2  and 0.79 (0.67, 0.93) with BMI ≥30 kg/m 2  (P for heterogeneity = 0.55). The effects of canagliflozin on each component of the composite were also similar across BMI subgroups, as were effects on heart failure and renal outcomes (P for heterogeneity ≥0.19). The effects on safety outcomes were also broadly similar.
CONCLUSIONS


Canagliflozin improved cardiovascular and renal outcomes consistently across patients with a broad range of BMI levels.",2020,"Mean body weight reduction with canagliflozin compared to placebo was greater at 12 months (-2.47 kg [95% CI: -2.64, -2.30]) than at 3 months (-1.53 kg [95% CI: -1.63, -1.44]).","['10,128 participants with baseline BMI measurements were included', '10,142 participants with type 2 diabetes to', '966 participants with BMI <25 kg/m 2  , 3153 with BMI 25-<30 kg/m 2  , and 6009 with BMI ≥30 kg/m 2  ']","['canagliflozin', 'canagliflozin or placebo', 'Sodium glucose co-transporter 2 (SGLT2) inhibitors', 'placebo', 'Canagliflozin']","['Mean body weight reduction', 'BMI levels for cardiovascular, renal, safety, and body weight outcomes', 'cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke', 'heart failure, renal, and safety outcomes', 'risks of cardiovascular and renal events', 'plasma glucose, blood pressure, albuminuria and body weight', 'cardiovascular and renal outcomes']","[{'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C2974540', 'cui_str': 'canagliflozin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4301634', 'cui_str': 'Sodium-glucose co-transporter 2 (SGLT2) inhibitors'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}]",966.0,0.478259,"Mean body weight reduction with canagliflozin compared to placebo was greater at 12 months (-2.47 kg [95% CI: -2.64, -2.30]) than at 3 months (-1.53 kg [95% CI: -1.63, -1.44]).","[{'ForeName': 'Toshiaki', 'Initials': 'T', 'LastName': 'Ohkuma', 'Affiliation': 'The George Institute for Global Health, UNSW Sydney, Sydney, Australia.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Van Gaal', 'Affiliation': 'Antwerp University Hospital, Antwerp, Belgium.'}, {'ForeName': 'Wayne', 'Initials': 'W', 'LastName': 'Shaw', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, New Jersey.'}, {'ForeName': 'Kenneth W', 'Initials': 'KW', 'LastName': 'Mahaffey', 'Affiliation': 'Stanford Center for Clinical Research, Department of Medicine, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Dick', 'Initials': 'D', 'LastName': 'de Zeeuw', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Matthews', 'Affiliation': 'Oxford Centre for Diabetes, Endocrinology and Metabolism and Harris Manchester College, University of Oxford, Oxford, UK.'}, {'ForeName': 'Vlado', 'Initials': 'V', 'LastName': 'Perkovic', 'Affiliation': 'The George Institute for Global Health, UNSW Sydney, Sydney, Australia.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Neal', 'Affiliation': 'The George Institute for Global Health, UNSW Sydney, Sydney, Australia.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13920']
268,31366980,A randomized feasibility study of the effect of ascorbic acid on post-angioplasty restenosis of hemodialysis vascular access (NCT03524846).,"Restenosis remains a significant problem after angioplasty of hemodialysis vascular access. Both experimental and clinical studies have shown a protective effect of antioxidants against post-angioplasty restenosis. A prospective, randomized, feasibility study was conducted to investigate the effect of ascorbic acid to prevent restenosis. Ninety-three hemodialysis patients were randomized into three groups after angioplasty: placebo (n = 31), 300 mg ascorbic acid (n = 31), and 600 mg ascorbic acid (n = 31), treated intravenously 3 times per week for 3 months. Eighty-nine completed the clinical follow-up, and 81 had angiographic follow-up. In the angiographic follow-up, the mean (stand deviation) late loss of luminal diameter for the placebo, 300 mg, and 600 mg groups were 3.15 (1.68) mm, 2.52 (1.70) mm (P = 0.39 vs. placebo group), and 1.59 (1.67) mm (P = 0.006, vs. placebo group), with corresponding angiographic binary restenosis of 79%, 67% (P = 0.38 vs. placebo group), and 54% (P = 0.08 vs. placebo group). The post-interventional primary patency rates at 3 months were 47%, 55% (P = 0.59 vs. placebo group), and 70% (P = 0.18 vs. placebo group) for placebo, 300 mg, and 600 mg groups. Our results demonstrated that intravenous 600 mg ascorbic acid was a feasible therapy and might attenuate restenosis after angioplasty; however, its effect on post-interventional primary patency was modest.",2019,"The post-interventional primary patency rates at 3 months were 47%, 55% (P = 0.59 vs. placebo group), and 70% (P = 0.18 vs. placebo group) for placebo, 300 mg, and 600 mg groups.","['Ninety-three hemodialysis patients', 'Eighty-nine completed the clinical follow-up, and 81 had angiographic follow-up']","['angioplasty: placebo', 'placebo', 'ascorbic acid']","['angiographic binary restenosis', 'mean (stand deviation) late loss of luminal diameter', 'patency rates']","[{'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0162577', 'cui_str': 'Angioplasty'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}]","[{'cui': 'C0333186', 'cui_str': 'Restenosis'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C0012727', 'cui_str': 'Displacement (morphologic abnormality)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0699493', 'cui_str': 'Luminal'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}]",89.0,0.228914,"The post-interventional primary patency rates at 3 months were 47%, 55% (P = 0.59 vs. placebo group), and 70% (P = 0.18 vs. placebo group) for placebo, 300 mg, and 600 mg groups.","[{'ForeName': 'Chung-Wei', 'Initials': 'CW', 'LastName': 'Yang', 'Affiliation': 'Division of Nephrology, Department of Medicine, National Taiwan University Hospital, Hsinchu Branch, Hsinchu, Taiwan.'}, {'ForeName': 'Chih-Cheng', 'Initials': 'CC', 'LastName': 'Wu', 'Affiliation': 'Cardiovascular Center, National Taiwan University Hospital, Hsinchu Branch, Hsinchu, Taiwan. chihchengwumd@gmail.com.'}, {'ForeName': 'Chien-Ming', 'Initials': 'CM', 'LastName': 'Luo', 'Affiliation': 'Division of Cardiovascular Surgery, Department of Surgery, National Taiwan University Hospital, Hsinchu Branch, Hsinchu, Taiwan.'}, {'ForeName': 'Shao-Yuan', 'Initials': 'SY', 'LastName': 'Chuang', 'Affiliation': 'Division of Preventive Medicine and Health Services Research, Institute of Population Health Sciences, National Health Research Institutes, Miaoli, Taiwan.'}, {'ForeName': 'Chiu-Hui', 'Initials': 'CH', 'LastName': 'Chen', 'Affiliation': 'Department of Nursing, National Taiwan University Hospital, Hsinchu Branch, Hsinchu, Taiwan.'}, {'ForeName': 'Yung-Fang', 'Initials': 'YF', 'LastName': 'Shen', 'Affiliation': 'Department of Nursing, National Taiwan University Hospital, Hsinchu Branch, Hsinchu, Taiwan.'}, {'ForeName': 'Der-Cheng', 'Initials': 'DC', 'LastName': 'Tarng', 'Affiliation': 'Department and Institute of Physiology, National Yang-Ming University, Taipei, Taiwan. dctarng@gmail.com.'}]",Scientific reports,['10.1038/s41598-019-47583-w']
269,31634898,A multipredictor model to predict the conversion of mild cognitive impairment to Alzheimer's disease by using a predictive nomogram.,"Predicting the probability of converting from mild cognitive impairment (MCI) to Alzheimer's disease (AD) is still a challenging task. This study aims at providing a personalized MCI-to-AD conversion estimation by using a multipredictor nomogram that integrates neuroimaging features, cerebrospinal fluid (CSF) biomarker, and clinical assessments. To do so, 290 MCI patients were collected from the Alzheimer's Disease Neuroimaging Initiative (ADNI), of whom 76 has converted to AD and 214 remained with MCI. All subjects were randomly divided into a primary and validation cohort. Radiomics signature (Rad-sig) was obtained based on 17 cerebral cortex features selected by using Least Absolute Shrinkage and Selection Operator (LASSO) algorithm. Clinical factors and amyloid-beta peptide (Aβ) concentration were selected by using Spearman correlation between the converted and not-converted patients. Then, a nomogram that combines image features, clinical factor, and Aβ concentration was constructed and validated. Furthermore, we explored the associations between various predictors from the macro- to the microperspective by assessing gene expression patterns. Our results showed that the multipredictor nomogram (C-index 0.978 and 0.956 in both cohorts, respectively) outperformed the nomogram using either Rad-sig or Aβ concentration as individual predictors. Significant associations were found between neuropsychological scores, cerebral cortex features, Aβ levels, and underlying gene pathways. Our study may have a clinical impact as a powerful predictive tool for predicting the conversion probability of MCI and providing associations between cognitive impairment, structural changes, Aβ levels, and underlying biological patterns from the macro- to the microperspective.",2020,"Significant associations were found between neuropsychological scores, cerebral cortex features, Aβ levels, and underlying gene pathways.","[""290 MCI patients were collected from the Alzheimer's Disease Neuroimaging Initiative (ADNI), of whom 76 has converted to AD and 214 remained with MCI""]",[],"['neuropsychological scores, cerebral cortex features, Aβ levels, and underlying gene pathways', 'Clinical factors and amyloid-beta peptide (Aβ) concentration']","[{'cui': 'C0560005', 'cui_str': 'millicurie'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0424093', 'cui_str': 'Initiative (observable entity)'}]",[],"[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0007776', 'cui_str': 'Cortical Plate'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0078939', 'cui_str': ""Alzheimer's ABP""}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",,0.0173736,"Significant associations were found between neuropsychological scores, cerebral cortex features, Aβ levels, and underlying gene pathways.","[{'ForeName': 'Kexin', 'Initials': 'K', 'LastName': 'Huang', 'Affiliation': ""School of Life Science and Technology, Xidian University, Xi'an, Shaanxi, 710071, P. R. China.""}, {'ForeName': 'Yanyan', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': ""School of Life Science and Technology, Xidian University, Xi'an, Shaanxi, 710071, P. R. China.""}, {'ForeName': 'Lifeng', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': ""School of Life Science and Technology, Xidian University, Xi'an, Shaanxi, 710071, P. R. China.""}, {'ForeName': 'Yubo', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""School of Life Science and Technology, Xidian University, Xi'an, Shaanxi, 710071, P. R. China.""}, {'ForeName': 'Suping', 'Initials': 'S', 'LastName': 'Cai', 'Affiliation': ""School of Life Science and Technology, Xidian University, Xi'an, Shaanxi, 710071, P. R. China.""}, {'ForeName': 'Liaojun', 'Initials': 'L', 'LastName': 'Pang', 'Affiliation': ""School of Life Science and Technology, Xidian University, Xi'an, Shaanxi, 710071, P. R. China.""}, {'ForeName': 'Xiaoming', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': ""The Key Laboratory of Biomedical Information Engineering of Ministry of Education, School of Life Sciences and Technology, Xi'an Jiaotong University, Xi'an, 710049, P. R. China.""}, {'ForeName': 'Liyu', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': ""School of Life Science and Technology, Xidian University, Xi'an, Shaanxi, 710071, P. R. China. huangly@mail.xidian.edu.cn.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0551-0']
270,30033775,Development of a Workplace Intervention for Child Care Staff: Caring and Reaching for Health's (CARE) Healthy Lifestyles Intervention.,"Child care staff are among the lowest wage workers, a group at increased risk for a wide array of chronic diseases. To date, the health of child care staff has been largely ignored, and there have been very few interventions designed for child care staff. This article describes the development of the Caring and Reaching for Health (CARE) Healthy Lifestyles intervention, a workplace intervention aimed at improving physical activity and health behaviors among child care staff. Theory and evidence-based behavior change techniques informed the development of intervention components with targets at multiple social ecological levels. Final intervention components included an educational workshop held at a kick-off event, followed by three 8-week campaigns. Intervention components within each campaign included (1) an informational magazine, (2) goal setting and weekly behavior self-monitoring, (3) weekly tailored feedback, (4) e-mail/text prompts, (5) center-level displays that encouraged team-based goals and activities, and (6) coaching for center directors. This multilevel, theory-driven intervention is currently being evaluated as part of a larger randomized controlled trial. Process evaluation efforts will assess the extent to which child care staff participated in, engaged with, and were satisfied with the intervention. Lessons learned will guide future intervention research engaging child care workers.",2020,"Process evaluation efforts will assess the extent to which child care staff participated in, engaged with, and were satisfied with the intervention.","['child care staff', ""Caring and Reaching for Health's (CARE"", 'Healthy Lifestyles Intervention', 'Child Care Staff']","['informational magazine, (2) goal setting and weekly behavior self-monitoring, (3) weekly tailored feedback, (4) e-mail/text prompts, (5) center-level displays that encouraged team-based goals and activities, and (6) coaching for center directors', 'Workplace Intervention']",['Caring and Reaching for Health (CARE'],"[{'cui': 'C0008078', 'cui_str': 'Childrens Health'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C4277664', 'cui_str': 'Healthy Life Styles'}]","[{'cui': 'C0162443', 'cui_str': 'Magazines'}, {'cui': 'C0150598', 'cui_str': 'Goal setting (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0588436', 'cui_str': 'Self-monitoring (regime/therapy)'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C3541382', 'cui_str': 'Text'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0557773', 'cui_str': 'Coach (physical object)'}, {'cui': 'C0162579', 'cui_str': 'Job Site'}]","[{'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",,0.0190863,"Process evaluation efforts will assess the extent to which child care staff participated in, engaged with, and were satisfied with the intervention.","[{'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Arandia', 'Affiliation': 'University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Amber E', 'Initials': 'AE', 'LastName': 'Vaughn', 'Affiliation': 'University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Lori A', 'Initials': 'LA', 'LastName': 'Bateman', 'Affiliation': 'University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Dianne S', 'Initials': 'DS', 'LastName': 'Ward', 'Affiliation': 'University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Linnan', 'Affiliation': 'University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}]",Health promotion practice,['10.1177/1524839918786214']
271,32307658,A randomized phase II trial evaluating two non-pharmacologic interventions in cancer survivors for the treatment of sleep-wake disturbances: NCCTG N07C4 (Alliance).,"PURPOSE


Sleep disturbance is a prevalent problem for cancer survivors and effective behavioral treatments are not widely used for this population. This study evaluated home-based sleep interventions based on cognitive behavioral therapy for insomnia (CBT-I).
METHODS


This phase II randomized controlled trial evaluated two manualized interventions over 7 weeks. The intervention group received sleep hygiene information, stimulus control, sleep restriction, and a bedtime imagery audio recording. The control group was similar, but without sleep restriction and used audio recordings of bedtime short stories instead of imagery. Eligibility included adult cancer survivors who had trouble falling asleep or falling back to sleep on 3 of 7 days. Patients with diagnoses of sleep or mental health disorders were excluded. The primary endpoint was change in time to fall asleep or falling back to sleep after awakening, from baseline to week 7. Two-sample T tests evaluated differences between arms for this endpoint.
RESULTS


Ninety-three of 168 planned participants were enrolled from 20 institutions. The study closed early for poor accrual. Baseline time to sleep was 45 min and 52 min for the intervention and control group, respectively. At 7 weeks, both groups improved, the intervention group to 26 min and control group to 30 min, a non-significant difference between groups (p = 0.85). Secondary outcomes improved in both groups with no significant differences between arms.
CONCLUSIONS


Improvement in sleep outcomes in both arms was consistent with other CBT-I interventions delivered through alternative approaches to provider-delivered therapy. More research on optimal scalable delivery of CBT-I is needed.
CLINICAL RELEVANCE


This study supports the effectiveness of CBT-I based behavioral interventions for sleep but also the need for better delivery methods to improve uptake and effect size.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT00993928.",2020,"At 7 weeks, both groups improved, the intervention group to 26 min and control group to 30 min, a non-significant difference between groups (p = 0.85).","['Patients with diagnoses of sleep or mental health disorders', 'Ninety-three of 168 planned participants were enrolled from 20 institutions', 'cancer survivors for the treatment of sleep-wake disturbances: NCCTG N07C4 (Alliance', 'Eligibility included adult cancer survivors who had trouble falling asleep or falling back to sleep on 3 of 7\xa0days']","['home-based sleep interventions based on cognitive behavioral therapy', 'sleep hygiene information, stimulus control, sleep restriction, and a bedtime imagery audio recording', 'CBT-I based behavioral interventions']","['change in time to fall asleep or falling back to sleep', 'sleep outcomes', 'Baseline time to sleep']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0393760', 'cui_str': 'Initial insomnia'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C4277672', 'cui_str': 'Good Sleep Habits'}, {'cui': 'C0871436', 'cui_str': 'Stimulus control'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0521112', 'cui_str': 'Bedtime'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0424522', 'cui_str': 'Asleep'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",,0.0861286,"At 7 weeks, both groups improved, the intervention group to 26 min and control group to 30 min, a non-significant difference between groups (p = 0.85).","[{'ForeName': 'Debra L', 'Initials': 'DL', 'LastName': 'Barton', 'Affiliation': 'University of Michigan School of Nursing, 400 N. Ingalls, Room 4320, Ann Arbor, MI, 48109-5482, USA. debbartn@med.umich.edu.'}, {'ForeName': 'Pamela J', 'Initials': 'PJ', 'LastName': 'Atherton', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Daniel V', 'Initials': 'DV', 'LastName': 'Satele', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Qin', 'Affiliation': 'Janssen Pharmaceuticals, Raritan, NJ, Belgium.'}, {'ForeName': 'Shaker', 'Initials': 'S', 'LastName': 'Dakhil', 'Affiliation': 'Wichita NCORP, Wichita, KS, USA.'}, {'ForeName': 'Teri', 'Initials': 'T', 'LastName': 'Pipe', 'Affiliation': 'Arizona State University, Tempe, AZ, USA.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Hobday', 'Affiliation': 'Mayo Clinic Cancer Center, Rochester, MN, USA.'}, {'ForeName': 'Kelli', 'Initials': 'K', 'LastName': 'Fee-Schroeder', 'Affiliation': 'Mayo Clinic Cancer Center, Rochester, MN, USA.'}, {'ForeName': 'Charles L', 'Initials': 'CL', 'LastName': 'Loprinzi', 'Affiliation': 'Mayo Clinic Cancer Center, Rochester, MN, USA.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-020-05461-6']
272,30355445,Changes in global and thalamic brain connectivity in LSD-induced altered states of consciousness are attributable to the 5-HT2A receptor.,"Background


Lysergic acid diethylamide (LSD) has agonist activity at various serotonin (5-HT) and dopamine receptors. Despite the therapeutic and scientific interest in LSD, specific receptor contributions to its neurobiological effects remain unknown.
Methods


We therefore conducted a double-blind, randomized, counterbalanced, cross-over studyduring which 24 healthy human participants received either (i) placebo+placebo, (ii) placebo+LSD (100 µg po), or (iii) Ketanserin, a selective 5-HT2A receptor antagonist,+LSD. We quantified resting-state functional connectivity via a data-driven global brain connectivity method and compared it to cortical gene expression maps.
Results


LSD reduced associative, but concurrently increased sensory-somatomotor brain-wide and thalamic connectivity. Ketanserin fully blocked the subjective and neural LSD effects. Whole-brain spatial patterns of LSD effects matched 5-HT2A receptor cortical gene expression in humans.
Conclusions


Together, these results strongly implicate the 5-HT2A receptor in LSD’s neuropharmacology. This study therefore pinpoints the critical role of 5-HT2A in LSD’s mechanism, which informs its neurobiology and guides rational development of psychedelic-based therapeutics.
Funding


Funded by the Swiss National Science Foundation, the Swiss Neuromatrix Foundation, the Usona Institute, the NIH, the NIAA, the NARSAD Independent Investigator Grant, the Yale CTSA grant, and the Slovenian Research Agency.
Clinical trial number


NCT02451072",2018,"Ketanserin, a selective 5-HT 2A  receptor","['24 healthy human participants received either', 'humans']","['Lysergic acid diethylamide (LSD', 'Ketanserin', 'i) placebo+placebo, (ii) placebo+LSD']","['sensory-somatomotor brain-wide and thalamic connectivity', 'subjective and neural LSD effects']","[{'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0024334', 'cui_str': 'LSD'}, {'cui': 'C0022616', 'cui_str': 'Ketanserin'}]","[{'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0024334', 'cui_str': 'LSD'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",,0.204347,"Ketanserin, a selective 5-HT 2A  receptor","[{'ForeName': 'Katrin H', 'Initials': 'KH', 'LastName': 'Preller', 'Affiliation': 'Neuropsychopharmacology and Brain Imaging, Department of Psychiatry, Psychotherapy and Psychosomatics, University Hospital for Psychiatry Zurich, Zurich, Switzerland.'}, {'ForeName': 'Joshua B', 'Initials': 'JB', 'LastName': 'Burt', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, United States.'}, {'ForeName': 'Jie Lisa', 'Initials': 'JL', 'LastName': 'Ji', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, United States.'}, {'ForeName': 'Charles H', 'Initials': 'CH', 'LastName': 'Schleifer', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, United States.'}, {'ForeName': 'Brendan D', 'Initials': 'BD', 'LastName': 'Adkinson', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, United States.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Stämpfli', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, University Hospital for Psychiatry Zurich, Zurich, Switzerland.'}, {'ForeName': 'Erich', 'Initials': 'E', 'LastName': 'Seifritz', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, University Hospital for Psychiatry Zurich, Zurich, Switzerland.'}, {'ForeName': 'Grega', 'Initials': 'G', 'LastName': 'Repovs', 'Affiliation': 'Mind and Brain Lab, Department of Psychology, University of Ljubljana, Ljubljana, Slovenia.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Krystal', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, United States.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Murray', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, United States.'}, {'ForeName': 'Franz X', 'Initials': 'FX', 'LastName': 'Vollenweider', 'Affiliation': 'Neuropsychopharmacology and Brain Imaging, Department of Psychiatry, Psychotherapy and Psychosomatics, University Hospital for Psychiatry Zurich, Zurich, Switzerland.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Anticevic', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, United States.'}]",eLife,['10.7554/eLife.35082']
273,32191657,A preliminary report on the use of Midodrine in treating refractory gastroesophageal disease: Randomized Double-Blind Controlled Trial.,"BACKGROUND


Gastroesophageal reflux disease (GERD) is a common disease with various clinical presentations. Acid suppression with proton pump inhibitors and lifestyle modification may not lead to satisfactory response in a substantial portion of patients. We investigated the possible effect of midodrine in patients with refractory GERD.
METHODS


Patients suffering from GERD and were refractory to one-month course of pantoprazole 40mg twice daily entered the study. This was a pilot, randomized, double-blind, and placebo-controlled study. After randomization, one group received Midodrine 5mg before meals for one month, and the other group received placebo for the same period. Meanwhile, pantoprazole was continued 40mg twice daily in both arms. The severity of symptoms was evaluated by the visual scoring system. Quality of life (QoL) in both groups was measured using a standardized version of Quality of Life in Reflux and Dyspepsia questionnaire (QOLRAD).
RESULTS


A total of twenty patients were enrolled in this study. There was a significant interaction between the groups and time on all measured scores based on QOLRAD questionnaire. All the markers in the Midodrine group had significant improvement over time, but the placebo group did not show any significant improvement. Both visual severity score and total QoL score in Midodrine arm showed a U shape change during  6 weeks.
CONCLUSIONS


Midodrine before a meal could be useful in alleviating symptoms and improving QoL in the patients with refractory gastroesophageal disease.",2020,"All the markers in the Midodrine group had significant improvement over time, but the placebo group did not show any significant improvement.","['Patients suffering from GERD and were refractory to one-month course of', 'refractory gastroesophageal disease', 'A total of twenty patients were enrolled in this study', 'patients with refractory gastroesophageal disease', 'patients with refractory GERD']","['pantoprazole', 'placebo', 'Meanwhile, pantoprazole', 'Midodrine', 'midodrine']","['severity of symptoms', 'standardized version of Quality of Life in Reflux and Dyspepsia questionnaire (QOLRAD', 'Quality of life (QoL', 'visual severity score and total QoL score', 'alleviating symptoms and improving QoL', 'QOLRAD questionnaire']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0017168', 'cui_str': 'Gastric Acid Reflux Disease'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C4082115', 'cui_str': 'One month (qualifier value)'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0081876', 'cui_str': 'pantoprazole'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0026078', 'cui_str': 'Midodrine'}]","[{'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0034380'}, {'cui': 'C0013395', 'cui_str': 'Indigestion'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0457451', 'cui_str': 'Severity score (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1274136', 'cui_str': 'Symptom control'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}]",20.0,0.426009,"All the markers in the Midodrine group had significant improvement over time, but the placebo group did not show any significant improvement.","[{'ForeName': 'Kamran', 'Initials': 'K', 'LastName': 'Bagheri Lankarani', 'Affiliation': '. lankaran@sums.ac.ir.'}, {'ForeName': 'Gholam Reza', 'Initials': 'GR', 'LastName': 'Sivandzadeh', 'Affiliation': '. ghsivand@sums.ac.ir.'}, {'ForeName': 'Marziyeh', 'Initials': 'M', 'LastName': 'Zare', 'Affiliation': 'Health Policy Research Center, Institute of Health, Shiraz University of Medical Sciences. marziyeh.zare70@gmail.com.'}, {'ForeName': 'Mohammadali', 'Initials': 'M', 'LastName': 'Nejati', 'Affiliation': '. nejati@sums.ac.ir.'}, {'ForeName': 'Ramin', 'Initials': 'R', 'LastName': 'Niknam', 'Affiliation': '. peymanip@sums.ac.ir.'}, {'ForeName': 'Ali Reza', 'Initials': 'AR', 'LastName': 'Taghavi', 'Affiliation': '. ataghavi@sums.ac.ir.'}, {'ForeName': 'Fardad', 'Initials': 'F', 'LastName': 'Ejtehadi', 'Affiliation': '. edjtehadif@sums.ac.ir.'}, {'ForeName': 'Mahvash Alizade', 'Initials': 'MA', 'LastName': 'Naini', 'Affiliation': '. Alizadem@sums.ac.ir.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Moini', 'Affiliation': '. Dornam@hotmail.com.'}, {'ForeName': 'Mohammad Hossein', 'Initials': 'MH', 'LastName': 'Anbardar', 'Affiliation': '. anbardarm@sums.ac.ir.'}, {'ForeName': 'Payam', 'Initials': 'P', 'LastName': 'Peymani', 'Affiliation': 'Health Policy Research Center, Institute of Health, Shiraz University of Medical Sciences, Shiraz, Fars, Iran.. peymanip@sums.ac.ir.'}]",Acta bio-medica : Atenei Parmensis,['10.23750/abm.v91i1.8486']
274,31400518,Scalability of cancer SurvivorLink™: A cluster randomized trial among pediatric cancer clinics.,"BACKGROUND


Children diagnosed with cancer are living longer and the survivor population is growing. However, most survivors develop late effects of radiation and chemotherapy shortly to years after completion of therapy, and the receipt of follow-up visits that are recommended by the Children's Oncology Group (COG) is suboptimal nationally.
AIMS


The aims of this study are to: 1) evaluate the impact of a patient-controlled electronic personal health record (ePHR) and system (SurvivorLink) on care visit attendance, risk-based surveillance, and other secondary outcomes (i.e., patient activation, quality of life (QOL)); 2) measure the use, acceptability, and perceived usefulness of, and satisfaction with SurvivorLink; and 3) assess facilitators and barriers to implementation.
METHODS


This hybrid effectiveness-implementation, clustered randomized control trial (RCT) evaluates the effect of SurvivorLink among pediatric cancer survivors and their parents on receipt of follow-up cancer care. We will recruit 20 pediatric survivor clinics with half receiving the intervention and half acting as a waitlist control. Parents of survivors and survivors will complete baseline, 3 and 12 month surveys that assess SurvivorLink use, patient self-efficacy, and intentions to return for follow-up. We will use mixed methods and multi-informant assessment to assess implementation outcomes (i.e., acceptability, feasibility, appropriateness).
DISCUSSION


New approaches are needed to facilitate the receipt of long-term follow-up care among pediatric cancer survivors. This study will assess whether SurvivorLink is effective in increasing receipt of follow-up cancer care. Moreover, it will explore the influences of context and other moderators of clinical practice change in pediatric cancer survivorship.",2019,"This hybrid effectiveness-implementation, clustered randomized control trial (RCT) evaluates the effect of SurvivorLink among pediatric cancer survivors and their parents on receipt of follow-up cancer care.","['pediatric cancer clinics', 'pediatric cancer survivors and their parents on receipt of follow-up cancer care', 'Scalability of cancer SurvivorLink™', '20 pediatric survivor clinics with half receiving the intervention and half acting as a waitlist control', 'pediatric cancer survivors']","['patient-controlled electronic personal health record (ePHR) and system (SurvivorLink', 'SurvivorLink']","['care visit attendance, risk-based surveillance, and other secondary outcomes (i.e., patient activation, quality of life (QOL)); 2) measure the use, acceptability, and perceived usefulness of, and satisfaction with SurvivorLink; and 3) assess facilitators and barriers to implementation']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0018739', 'cui_str': 'Personal Health Records'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0733511', 'cui_str': 'Surveillance (regime/therapy)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C3853034', 'cui_str': 'Patient Activation'}, {'cui': 'C0034380'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}]",,0.0903792,"This hybrid effectiveness-implementation, clustered randomized control trial (RCT) evaluates the effect of SurvivorLink among pediatric cancer survivors and their parents on receipt of follow-up cancer care.","[{'ForeName': 'Cam', 'Initials': 'C', 'LastName': 'Escoffery', 'Affiliation': 'Rollins School of Public Health, Emory, 1518 Clifton Road, Atlanta, GA 30322, USA. Electronic address: cescoff@emory.edu.'}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Gilleland Marchak', 'Affiliation': ""Department of Pediatrics, Emory University; Aflac Cancer and Blood Disorder Center, Children's Healthcare of Atlanta, 1405 Clifton Rd, Atlanta, GA 30322, USA. Electronic address: jgillel@emory.edu.""}, {'ForeName': 'Regine', 'Initials': 'R', 'LastName': 'Haardörfer', 'Affiliation': 'Rollins School of Public Health, Emory, 1518 Clifton Road, Atlanta, GA 30322, USA. Electronic address: regine.haardoerfer@emory.edu.'}, {'ForeName': 'Lillian', 'Initials': 'L', 'LastName': 'Meacham', 'Affiliation': ""Department of Pediatrics, Emory University; Aflac Cancer and Blood Disorder Center, Children's Healthcare of Atlanta, 1405 Clifton Rd, Atlanta, GA 30322, USA. Electronic address: lillian.meacham@emory.edu.""}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Williamson Lewis', 'Affiliation': ""Aflac Cancer and Blood Disorder Center, Children's Healthcare of Atlanta, 1405 Clifton Rd, Atlanta, GA 30322, USA. Electronic address: rebecca.lewis@choa.org.""}, {'ForeName': 'Hallie', 'Initials': 'H', 'LastName': 'Udelson', 'Affiliation': 'Rollins School of Public Health, Emory, 1518 Clifton Road, Atlanta, GA 30322, USA. Electronic address: hallie.udelson@emory.edu.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Edwards', 'Affiliation': 'Himformatics, 1579 Monroe Drive NE, Suite 410, Atlanta, GA 30324, USA. Electronic address: pedwards@himformatics.com.'}, {'ForeName': 'Ann C', 'Initials': 'AC', 'LastName': 'Mertens', 'Affiliation': ""Department of Pediatrics, Emory University; Aflac Cancer and Blood Disorder Center, Children's Healthcare of Atlanta, 1405 Clifton Rd, Atlanta, GA 30322, USA. Electronic address: amerten@emory.edu.""}]",Contemporary clinical trials,['10.1016/j.cct.2019.105819']
275,31590179,Influence of combined treatment with naltrexone and memantine on alcohol drinking behaviors: a phase II randomized crossover trial.,"Glutamate and opioid systems play important roles in alcohol drinking behaviors. We examined if combined treatment with the NMDA antagonist memantine and the opioid antagonist naltrexone, when compared with naltrexone alone, would have a greater influence on alcohol drinking behaviors. Fifty-six, non-treatment-seeking heavy drinkers, with alcohol dependence and a positive family history (FHP) of alcoholism, participated in a randomized, double-blind, crossover trial, including two 6-8 days treatment periods, separated by a 6-day washout, and 3 alcohol drinking paradigm (ADP) sessions. After the first baseline (BAS) ADP1 session, participants were randomized to receive either naltrexone (NTX; 50 mg/day) + placebo memantine, or NTX (50 mg/day) + memantine (MEM; 20 mg/day), during the first treatment period, following which they completed ADP2. After a 6-day washout, participants were crossed over to the treatment they did not receive during the first treatment period, following which they completed ADP3. During each ADP, participants received a priming drink of alcohol followed by 3 1-hour, self-administration periods during which they had ad-lib access to 12 drinks. Individually, both NTX and NTX + MEM, when compared to BAS ADP1, significantly reduced the number of drinks consumed (p's < 0.001) and craving (p's < 0.001). When comparing NTX + MEM vs. NTX on number of drinks consumed, there was a significant treatment* sequence interaction (p = 0.004). Specifically, when NTX + MEM followed NTX alone, NTX + MEM resulted in a further reduction in drinking (mean: -1.94; 95% CI: -2.6, -0.8, p = 0.0005). However, when NTX alone followed NTX + MEM, NTX alone did not lead to further reduction in drinking (mean: 0.59; 95% CI: -0.67, 1.43, p = 0.47). Similar patterns were observed for alcohol craving; specifically, a significant reduction in craving was observed when NTX + MEM followed NTX alone (p = 0.009), but craving reduction was maintained when NTX + MEM was followed by NTX alone. Neither treatment condition significantly influenced alcohol-induced stimulation or sedation. Memantine (at a dose of 20 mg/day) enhances the efficacy of naltrexone (50 mg/day) in reducing alcohol drinking and craving among FHP drinkers with beneficial effects that appear to carryover after discontinuation of memantine treatment.",2020,"When comparing NTX + MEM vs. NTX on number of drinks consumed, there was a significant treatment* sequence interaction (p = 0.004).","['Fifty-six, non-treatment-seeking heavy drinkers, with alcohol dependence and a positive family history (FHP) of alcoholism']","['Memantine', 'naltrexone', 'NTX\u2009+\u2009MEM vs. NTX', 'NMDA antagonist memantine', 'NTX', 'alcohol drinking paradigm (ADP) sessions', 'naltrexone (NTX; 50\u2009mg/day)\u2009+\u2009placebo memantine, or NTX (50\u2009mg/day)\u2009+\u2009memantine (MEM', 'opioid antagonist naltrexone', 'naltrexone and memantine', 'priming drink of alcohol']","['craving', 'alcohol craving', 'alcohol drinking behaviors', 'craving reduction', 'number of drinks consumed', 'alcohol drinking and craving', 'alcohol-induced stimulation or sedation']","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0337678', 'cui_str': 'Heavy drinker (finding)'}, {'cui': 'C0001973', 'cui_str': 'Alcohol Dependence'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0559555', 'cui_str': 'FH - Alcoholism'}]","[{'cui': 'C0025242', 'cui_str': 'Memantine'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C1979923', 'cui_str': 'Micro-Electro-Mechanical Systems'}, {'cui': 'C0079883', 'cui_str': 'N-Methyl-D-aspartate'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0027410', 'cui_str': 'Opioid Receptor Antagonists'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}]","[{'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0556385', 'cui_str': 'Craving for alcohol (finding)'}, {'cui': 'C0565662', 'cui_str': 'Finding relating to alcohol drinking behavior'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}]",12.0,0.0285429,"When comparing NTX + MEM vs. NTX on number of drinks consumed, there was a significant treatment* sequence interaction (p = 0.004).","[{'ForeName': 'Suchitra', 'Initials': 'S', 'LastName': 'Krishnan-Sarin', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA. suchitra.krishnan-sarin@yale.edu.'}, {'ForeName': 'Stephanie S', 'Initials': 'SS', 'LastName': ""O'Malley"", 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Franco', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA.'}, {'ForeName': 'Dana A', 'Initials': 'DA', 'LastName': 'Cavallo', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA.'}, {'ForeName': 'Jeanette M', 'Initials': 'JM', 'LastName': 'Tetrault', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Shi', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA.'}, {'ForeName': 'Ralitza', 'Initials': 'R', 'LastName': 'Gueorguieva', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Pittman', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Krystal', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0536-z']
276,32209984,"Surface-Specific Caries Preventive Effect of an Intervention Comprising Fissure Sealant, Povidone-Iodine and Fluoride Varnish in a Remote Indigenous Community in Australia.","This study evaluates the effect of a topical intervention comprising of fissure sealant, povidone-iodine, and fluoride varnish in preventing caries on occlusal, approximal, and smooth surfaces. This three-year clinical trial was conducted in a remote Indigenous community of Australia. All schoolchildren (age range: 4-17) were invited to participate; those with parental consents to receive three-annual epidemiological examinations and interventions constituted the experimental group, while those with consents for only the epidemiological examination formed a comparison group. The intervention group received an annual application of fissure sealant, povidone-iodine and fluoride varnish for two consecutive years along with the restoration of any cavitated lesions, while the comparison group did not receive any intervention except for the usual care that included emergency treatment and restorations. Incipient and advanced caries were recorded in the permanent dentition while data on confounding variables were collected through questionnaires. Caries increment and progression were the outcome variables. A total of 408 children participated in the baseline examination, 208 finished the study. After adjusting for confounders, the prevented fraction (PF) on occlusal surfaces for advanced caries in the experimental group was 76.1% (mean difference- -0.35, 95% CI: -0.67-0.04), while the PF for progression from incipient to advanced caries was 100%(mean difference- -0.30, 95% CI: -0.52-0.09). The mean number of smooth surfaces that progressed from incipient to advanced caries in the comparison group was more than twice that of the experimental group, the mean difference was -0.25 (95% CI: -0.46--0.03) with a PF of 61%. The intervention was only effective in preventing advanced caries on occlusal surfaces and in halting the progression of caries on occlusal and smooth surfaces but not on approximal caries.",2020,The intervention was only effective in preventing advanced caries on occlusal surfaces and in halting the progression of caries on occlusal and smooth surfaces but not on approximal caries.,"['All schoolchildren (age range: 4-17) were invited to participate; those with', 'remote Indigenous community of Australia', 'Remote Indigenous Community in Australia', '408 children participated in the baseline examination, 208 finished the study']","['comparison group did not receive any intervention except for the usual care that included emergency treatment and restorations', 'annual application of fissure sealant, povidone-iodine and fluoride varnish', 'parental consents to receive three-annual epidemiological examinations and interventions constituted the experimental group, while those with consents for only the epidemiological examination formed a comparison group', 'fissure sealant, povidone-iodine, and fluoride varnish', 'Fissure Sealant, Povidone-Iodine and Fluoride Varnish']","['prevented fraction (PF) on occlusal surfaces for advanced caries', 'mean number of smooth surfaces', 'caries on occlusal, approximal, and smooth surfaces', 'Incipient and advanced caries']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0205157', 'cui_str': 'Remote (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C4517769', 'cui_str': 'Four hundred and eight'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C1706059', 'cui_str': 'Finish - dosing instruction imperative'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0332300', 'cui_str': 'Except for (attribute)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0013969', 'cui_str': 'Therapy, Emergency'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration (attribute)'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0016168', 'cui_str': 'Fissure Sealants'}, {'cui': 'C0032857', 'cui_str': 'Povidone-Iodine'}, {'cui': 'C0016326', 'cui_str': 'Fluoride Varnishes'}, {'cui': 'C0600634', 'cui_str': 'Parental Consent'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}]","[{'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C0447303', 'cui_str': 'Structure of occlusal surface of tooth'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0333519', 'cui_str': 'Caries (morphologic abnormality)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205357', 'cui_str': 'Smooth (qualifier value)'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C1947917', 'cui_str': 'Occluded (qualifier value)'}, {'cui': 'C0205256', 'cui_str': 'Incipient (qualifier value)'}]",408.0,0.0432207,The intervention was only effective in preventing advanced caries on occlusal surfaces and in halting the progression of caries on occlusal and smooth surfaces but not on approximal caries.,"[{'ForeName': 'Santosh K', 'Initials': 'SK', 'LastName': 'Tadakamadla', 'Affiliation': 'School of Dentistry and Oral Health, Griffith University, Gold Coast, Queensland, QLD 4215, Australia.'}, {'ForeName': 'Ratilal', 'Initials': 'R', 'LastName': 'Lalloo', 'Affiliation': 'School of Dentistry, The University of Queensland, Herston, Queensland, QLD 4072, Australia.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Kroon', 'Affiliation': 'School of Dentistry and Oral Health, Griffith University, Gold Coast, Queensland, QLD 4215, Australia.'}, {'ForeName': 'Newell W', 'Initials': 'NW', 'LastName': 'Johnson', 'Affiliation': 'School of Dentistry and Oral Health, Griffith University, Gold Coast, Queensland, QLD 4215, Australia.'}]",International journal of environmental research and public health,['10.3390/ijerph17062114']
277,32299792,Teaching the National Institutes of Health Stroke Scale to Paramedics (E-Learning vs Video): Randomized Controlled Trial.,"BACKGROUND


Prompt and accurate identification of stroke victims is essential to reduce time from symptom onset to adequate treatment and to improve neurological outcomes. Most neurologists evaluate the extent of neurological deficit according to the National Institutes of Health Stroke Scale (NIHSS), but the use of this scale by paramedics, the first healthcare providers to usually take care of stroke victims, has proven unreliable. This might be, at least in part, due to the teaching method. The video used to teach NIHSS lacks interactivity, while more engaging electronic learning (e-learning) methods might improve knowledge acquisition.
OBJECTIVE


This study was designed to evaluate whether a highly interactive e-learning module could enhance NIHSS knowledge acquisition in paramedics.
METHODS


A randomized controlled trial comparing a specially designed e-learning module with the original NIHSS video was performed with paramedics working in Geneva, Switzerland. A registration number was not required as our study does not come into the scope of the Swiss federal law on human research. The protocol was nevertheless submitted to the local ethics committee (Project ID 2017-00847), which issued a ""Declaration of no objection."" Paramedics were excluded if they had prior knowledge of or previous training in the NIHSS, or if they had worked in a neurology or neurosurgery ward. The primary outcome was overall performance in the study quiz, which contained 50 questions. Secondary outcomes were performance by NIHSS item, time to course and quiz completion, user satisfaction regarding the learning method, user perception of the course duration, and probability the user would recommend the course to a colleague.
RESULTS


The study was completed by 39 paramedics. There was a better overall median score (36/50 vs 33/50, P=.04) and a higher degree of satisfaction regarding the learning method in the e-learning group (90% vs 37%, P=.002). Users who had followed the e-learning module were more likely to recommend the course to a colleague (95% vs 63%, P=.02). Paramedics in the e-learning group took more time to complete the course (93 vs 59 minutes, P<.001), but considered the duration to be more adequate (75% vs 32%, P=.01). Time to quiz completion was similar between groups (25 vs 38 minutes, P=.12).
CONCLUSIONS


Use of an e-learning module shows promising results in teaching the NIHSS to paramedics.",2020,"Paramedics in the e-learning group took more time to complete the course (93 vs 59 minutes, P<.001), but considered the duration to be more adequate (75% vs 32%, P=.01).","['paramedics', 'Paramedics were excluded if they had prior knowledge of or previous training in the NIHSS, or if they had worked in a neurology or neurosurgery ward', 'paramedics working in Geneva, Switzerland']",['highly interactive e-learning module'],"['overall median score', 'overall performance', 'Time to quiz completion', ""performance by NIHSS item, time to course and to quiz completion, user satisfaction regarding the learning method, user's perception of the course duration, and probability the user would recommend the course to a colleague""]","[{'cui': 'C0013963', 'cui_str': 'Paramedic'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C3472496', 'cui_str': 'National Institutes of Health stroke scale'}, {'cui': 'C0557351', 'cui_str': 'Employed'}, {'cui': 'C0027926', 'cui_str': 'Neurosurgery'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C3542953', 'cui_str': 'Module'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0033204', 'cui_str': 'Probability'}]",,0.0832196,"Paramedics in the e-learning group took more time to complete the course (93 vs 59 minutes, P<.001), but considered the duration to be more adequate (75% vs 32%, P=.01).","[{'ForeName': 'Avinash', 'Initials': 'A', 'LastName': 'Koka', 'Affiliation': 'Division of Emergency Medicine, Department of Anaesthesiology, Clinical Pharmacology, Intensive Care and Emergency Medicine, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Suppan', 'Affiliation': 'Division of Emergency Medicine, Department of Anaesthesiology, Clinical Pharmacology, Intensive Care and Emergency Medicine, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Cottet', 'Affiliation': 'Division of Emergency Medicine, Department of Anaesthesiology, Clinical Pharmacology, Intensive Care and Emergency Medicine, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Carrera', 'Affiliation': 'Stroke Center, Department of Neurology, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Loric', 'Initials': 'L', 'LastName': 'Stuby', 'Affiliation': 'Genève TEAM Ambulances, Geneva, Switzerland.'}, {'ForeName': 'Mélanie', 'Initials': 'M', 'LastName': 'Suppan', 'Affiliation': 'Division of Anesthesiology, Department of Anaesthesiology, Clinical Pharmacology, Intensive Care and Emergency Medicine, Geneva University Hospitals, Geneva, Switzerland.'}]",Journal of medical Internet research,['10.2196/18358']
278,32301592,The safety and efficacy of zero-fluoroscopy ablation versus conventional ablation in patients with supraventricular tachycardia.,"BACKGROUND


A zero fluoroscopy approach guided by a 3‑dimensional navigation system is an alternative to the traditional conventional fluoroscopy‑navigation approach for ablation of tachycardia.
AIMS


To compare the safety and efficacy of zero fluoroscopy ablation of supraventricular tachycardia (SVT) guided by the CARTO mapping system (CZF) alone, the EnSite zero fluoroscopy mapping system (EZF) alone, or the conventional fluoroscopy (CF) ablation method.
METHODS


From July 2015 to March 2017, patients admitted for SVT ablation were prospectively and consecutively enrolled in the CF, EZF, and CZF groups in a 1:1:1 ratio. The procedures for the CF group were performed using the traditional fluoroscopy method or the 3‑dimensional mapping method. All data were prospectively recorded by independent researchers. Procedure and fluoroscopic time as well as rate of success, recurrence, and complications in the 3 groups were analyzed.
RESULTS


One patient from the CZF group was moved to the CF group due to a severe venous malformation during catheter insertion. A total of 100 patients (100%) in the CF group, 100 patients (100%) in the EZF group (100%), and 99 patients (99%) in the CZF group successfully completed the electrophysiology study. There were no severe complications in any of the groups. The mean (SD) procedure time was 61.8 (36.2), 66.5 (24.2), and 65.4 (27.5) minutes in the CF, EZF, and CZF group, respectively. The median (interquartile range) fluoroscopy time of the CF group was 3.6 (2.1-8.8) minutes.
CONCLUSIONS


The zero fluoroscopy approach guided by the CARTO system is not inferior to the zero fluoroscopy approach guided by the EnSite system or a conventional fluoroscopic approach in terms of the efficiency and safety for ablation of SVT.",2020,A zero--fluoroscopic approach guided by the CARTOTM system is not inferior to a zero--fluoroscopic approach guided by the EnSiteTM system or a conventional fluoroscopic approach in terms of efficiency and safety for SVT ablation.,"['patients with supraventricular tachycardia', 'From July 2015 to March 2017, patients admitted for SVT ablation were consecutively enrolled in the CF, EZF, and CZF groups in a 1:1:1 ratio']","['zero fluoroscopic ablation of supraventricular tachycardia (SVT) guided by the CARTOTM mapping system (CZF) alone, the EnSiteTM zero fluoroscopic mapping system (EZF) alone, or the conventional fluoroscopy (CF) ablation method', 'CZF', 'CF', 'zero-fluoroscopy ablation versus conventional ablation', 'fluoroscopy radiofrequency catheter ablation']","['median/quartile fluoroscopy time', 'severe complications', 'safety and efficacy', 'severe venous malformation', 'mean (SD) procedure time', 'Procedure and fluoroscopic time, and rate of success, recurrence, and complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039240', 'cui_str': 'Supraventricular tachycardia'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0919414', 'cui_str': '0'}, {'cui': 'C1283195', 'cui_str': 'Mapping - action'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]","[{'cui': 'C0919414', 'cui_str': '0'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0039240', 'cui_str': 'Supraventricular tachycardia'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C1283195', 'cui_str': 'Mapping - action'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0162561', 'cui_str': 'Radiofrequency Catheter Ablation'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0265950', 'cui_str': 'Venous malformation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]",,0.0263017,A zero--fluoroscopic approach guided by the CARTOTM system is not inferior to a zero--fluoroscopic approach guided by the EnSiteTM system or a conventional fluoroscopic approach in terms of efficiency and safety for SVT ablation.,"[{'ForeName': 'Alselmi', 'Initials': 'A', 'LastName': 'Fadhle', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology, Wuhan, China'}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Hu', 'Affiliation': 'Health Management Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology, Wuhan, China'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology, Wuhan, China. newswangyan@tjh.tjmu.edu.cn'}]",Kardiologia polska,['10.33963/KP.15293']
279,32298143,Randomized Controlled Trial of a Novel Peer Concussion-Education Program for Collegiate Athletes.,"CONTEXT


The National Collegiate Athletic Association and US Department of Defense have called for educational programs to change the culture of concussion reporting, increase reporting behavior, and enhance the safety of players and service members.
OBJECTIVE


To evaluate the effects of a novel peer concussion-education program (PCEP) in changing knowledge, attitudes, and norms about concussion reporting among collegiate student-athletes and assess program implementation.
DESIGN


Randomized controlled trial and qualitative analysis of interviews.
SETTING


National Collegiate Athletic Association athletic teams from randomly selected colleges or universities.
PATIENTS OR OTHER PARTICIPANTS


A total of 1614 male and female student-athletes from 60 teams at 10 colleges and universities and 8 athletic trainers.
INTERVENTION(S)


The PCEP intervention trains 2 peer concussion educators to provide 2 education modules to their teammates. Knowledge, attitudes (oneself and teammates), and concussion occurrence or reporting were assessed at baseline, postintervention, and 1 month later. Eight athletic trainers were interviewed about program implementation.
RESULTS


Compared with the control group, the intervention group showed greater increases occurred postintervention and at 1 month in concussion knowledge ( F 1,2648  = 51.3,  P  < .0001), intention to report (oneself,  F 2,2633  = 82.3,  P  < .0001; teammates,  F 2,2624  = 53.9,  P  < .0001), return-to-play protocol knowledge, ( F 2,2632  = 28.4,  P  < .0001), direct subjective norms (oneself,  F 2,2625  = 51.7,  P  < .0001; teammates,  F 2,2644  = 40.6,  P  < .0001), direct perceived behavioral control (oneself,  F 2,2628  = 53.7,  P  < .0001; teammates,  F 2,2615  = 68.2,  P  < .0001), and indirect attitudes (oneself,  F 2,2626  = 47.1,  P  < .001; teammates,  F 2,2623  = 40.9,  P  < .0001). Peer concussion-education program participants discussed concussion more often with a teammate ( F 1,1396  = 13.96,  P  < .0001) or athletic staff ( F 1,1396  = 6.62,  P  < .001). Qualitative program analysis revealed both positive aspects of the PCEP and areas for improvement.
CONCLUSIONS


The PCEP showed promise in increasing concussion knowledge, intention to report concussion, reporting a teammate's concussion, and facilitating attitudinal changes that support reporting among student-athletes.",2020,"Compared with the control group, the intervention group showed greater increases occurred postintervention and at 1 month in concussion knowledge ( F 1,2648  = 51.3,  P  < .0001), intention to report (oneself,  F 2,2633  = 82.3,  P  < .0001; teammates,  F 2,2624  = 53.9,  P  < .0001), return-to-play protocol knowledge, ( F 2,2632  = 28.4,  P  < .0001), direct subjective norms (oneself,  F 2,2625  = 51.7,  P  < .0001; teammates,  F 2,2644  = 40.6,  P  < .0001), direct perceived behavioral control (oneself,  F 2,2628  = 53.7,  P  < .0001; teammates,  F 2,2615  = 68.2,  P  < .0001) and indirect attitudes (oneself,  F 2,2626  ","['1614 male and female student-athletes from 60 teams at 10 colleges and universities and 8 athletic trainers', 'Eight athletic trainers', 'National Collegiate Athletic Association athletic teams from randomly selected colleges or universities', 'Collegiate Athletes']","['novel peer concussion-education program (PCEP', 'Novel Peer Concussion-Education Program', 'PCEP']","['indirect attitudes (oneself,  F 2,2626', 'return-to-play protocol knowledge', 'concussion knowledge', 'Knowledge, attitudes (oneself and teammates), and concussion occurrence or reporting', 'athletic staff', 'direct subjective norms']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0591126', 'cui_str': 'AT-10'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C1510656', 'cui_str': 'Athletics'}, {'cui': 'C0453962', 'cui_str': 'Trainers'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0004083', 'cui_str': 'Association'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0006107', 'cui_str': 'Concussion injury of brain'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}]","[{'cui': 'C0439852', 'cui_str': 'Indirect'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C4042817', 'cui_str': 'Return to Play'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0006107', 'cui_str': 'Concussion injury of brain'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C1510656', 'cui_str': 'Athletics'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0237750', 'cui_str': 'Societal Norms'}]",1614.0,0.0448974,"Compared with the control group, the intervention group showed greater increases occurred postintervention and at 1 month in concussion knowledge ( F 1,2648  = 51.3,  P  < .0001), intention to report (oneself,  F 2,2633  = 82.3,  P  < .0001; teammates,  F 2,2624  = 53.9,  P  < .0001), return-to-play protocol knowledge, ( F 2,2632  = 28.4,  P  < .0001), direct subjective norms (oneself,  F 2,2625  = 51.7,  P  < .0001; teammates,  F 2,2644  = 40.6,  P  < .0001), direct perceived behavioral control (oneself,  F 2,2628  = 53.7,  P  < .0001; teammates,  F 2,2615  = 68.2,  P  < .0001) and indirect attitudes (oneself,  F 2,2626  ","[{'ForeName': 'Meredith E', 'Initials': 'ME', 'LastName': 'Kneavel', 'Affiliation': 'School of Nursing and Health Sciences, La Salle University, Philadelphia, PA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Ernst', 'Affiliation': 'Center for Concussion Education and Research, Chestnut Hill College, Philadelphia, PA.'}, {'ForeName': 'Kevin S', 'Initials': 'KS', 'LastName': 'McCarthy', 'Affiliation': 'Center for Concussion Education and Research, Chestnut Hill College, Philadelphia, PA.'}]",Journal of athletic training,['10.4085/1062-6050-0182.19']
280,32302659,Dextran- Versus Crystalloid-Based Prime in Cardiac Surgery: A Prospective Randomized Pilot Study.,"BACKGROUND


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


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


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


Our results suggest that a hyperoncotic dextran-based priming solution preserves intraoperative colloid oncotic pressure compared with crystalloid prime. Larger studies with clinically valid end points are necessary to evaluate hyperoncotic prime solutions further.",2020,"There were no significant differences in bleeding, transfusion requirements, organ function, systemic inflammation, or brain and myocardial injury markers between the groups at any time point.
","['cardiac surgery', 'Eighty cardiac surgery patients']","['Dextran- versus crystalloid-based prime', 'dextran', 'hyperoncotic dextran-based priming solution', 'dextran-based prime or a crystalloid prime containing Ringer acetate and mannitol']","['fluid balance, bleeding and transfusion requirements, pulmonary function, hemolysis, systemic inflammation, and markers of renal, hepatic, myocardial, and brain injury', 'net fluid balance', 'colloid oncotic pressure (COP) in serum during CPB', 'COP', 'CPB', 'intravenous fluid during CPB', 'Plasma free hemoglobin', 'intraoperative COP', 'bleeding, transfusion requirements, organ function, systemic inflammation, or brain and myocardial injury markers']","[{'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0086140', 'cui_str': 'Dextran'}, {'cui': 'C0056562', 'cui_str': 'Crystalloid'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0071973', 'cui_str': 'PRIME protocol'}, {'cui': 'C0331021', 'cui_str': 'Ligustrum vulgare'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0073384', 'cui_str': ""Ringer's acetate""}, {'cui': 'C0024730', 'cui_str': 'Mannitol'}]","[{'cui': 'C0016284', 'cui_str': 'Fluid balance'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0019054', 'cui_str': 'Haemolysis'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0270611', 'cui_str': 'Brain injury'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0009361', 'cui_str': 'Colloids'}, {'cui': 'C0311418', 'cui_str': 'Oncotic pressure'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C1289919', 'cui_str': 'Intravenous fluid'}, {'cui': 'C0948712', 'cui_str': 'Free plasma haemoglobin'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}]",80.0,0.332131,"There were no significant differences in bleeding, transfusion requirements, organ function, systemic inflammation, or brain and myocardial injury markers between the groups at any time point.
","[{'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Barbu', 'Affiliation': 'Department of Cardiology, Blekinge Hospital, Karlskrona, Sweden; Department of Molecular and Clinical Medicine, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Kolsrud', 'Affiliation': 'Department of Cardiothoracic Surgery, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Sven-Erik', 'Initials': 'SE', 'LastName': 'Ricksten', 'Affiliation': 'Department of Cardiothoracic Anaesthesia and Intensive Care, Sahlgrenska University Hospital, Gothenburg, Sweden; Department of Anesthesiology and Intensive Care, Institute of Clinical Sciences, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Göran', 'Initials': 'G', 'LastName': 'Dellgren', 'Affiliation': 'Department of Molecular and Clinical Medicine, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Department of Cardiothoracic Surgery, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Zetterberg', 'Affiliation': 'Clinical Neurochemistry Laboratory, Sahlgrenska University Hospital, Mölndal, Sweden; Department of Psychiatry and Neurochemistry, Institute of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, Mölndal, Sweden.'}, {'ForeName': 'Kaj', 'Initials': 'K', 'LastName': 'Blennow', 'Affiliation': 'Clinical Neurochemistry Laboratory, Sahlgrenska University Hospital, Mölndal, Sweden; Department of Psychiatry and Neurochemistry, Institute of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, Mölndal, Sweden.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Björk', 'Affiliation': 'Department of Cardiothoracic Surgery, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Thorén', 'Affiliation': 'Department of Cardiothoracic Anaesthesia and Intensive Care, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Christoffer', 'Initials': 'C', 'LastName': 'Hansson', 'Affiliation': 'Department of Cardiothoracic Surgery, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Jeppsson', 'Affiliation': 'Department of Molecular and Clinical Medicine, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Department of Cardiothoracic Surgery, Sahlgrenska University Hospital, Gothenburg, Sweden. Electronic address: anders.jeppsson@vgregion.se.'}]",The Annals of thoracic surgery,['10.1016/j.athoracsur.2020.03.031']
281,32301407,"Effect of daily consumption of cranberry beverage on insulin sensitivity and modification of cardiovascular risk factors in adults with obesity: a pilot, randomised, placebo-controlled study.","Cranberries are high in polyphenols, and epidemiological studies have shown that a high-polyphenol diet may reduce risk factors for diabetes and CVD. The present study aimed to determine if short-term cranberry beverage consumption would improve insulin sensitivity and other cardiovascular risk factors. Thirty-five individuals with obesity and with elevated fasting glucose or impaired glucose tolerance participated in a randomised, double-blind, placebo-controlled, parallel-designed pilot trial. Participants consumed 450 ml of low-energy cranberry beverage or placebo daily for 8 weeks. Changes in insulin sensitivity and cardiovascular risk factors including vascular reactivity, blood pressure, RMR, glucose tolerance, lipid profiles and oxidative stress biomarkers were evaluated. Change in insulin sensitivity via hyperinsulinaemic-euglycaemic clamp was not different between the two groups. Levels of 8-isoprostane (biomarker of lipid peroxidation) decreased in the cranberry group but increased in the placebo group (-2·18 v. +20·81 pg/ml; P = 0·02). When stratified by baseline C-reactive protein (CRP) levels, participants with high CRP levels (>4 mg/l) benefited more from cranberry consumption. In this group, significant differences in the mean change from baseline between the cranberry (n 10) and the placebo groups (n 7) in levels of TAG (-13·75 v. +10·32 %; P = 0·04), nitrate (+3·26 v. -6·28 µmol/l; P = 0·02) and 8-isoprostane (+0·32 v. +30·8 pg/ml; P = 0·05) were observed. These findings indicate that 8 weeks of daily cranberry beverage consumption may not impact insulin sensitivity but may be helpful in lowering TAG and changing certain oxidative stress biomarkers in individuals with obesity and a proinflammatory state.",2020,"Levels of 8-isoprostane (biomarker of lipid peroxidation) decreased in the cranberry group but increased in the placebo group (-2.18 pg/mL vs +20.81 pg/mL, p=0.02).","['Thirty-five obese individuals with elevated fasting glucose or impaired glucose tolerance participated', 'Obese Adults', 'obese individuals with a proinflammatory state']","['low-calorie cranberry beverage or placebo', 'polyphenol diet', 'placebo', 'Daily Consumption of Cranberry Beverage', 'Placebo']","['Insulin Sensitivity and Modification of Cardiovascular Risk Factors', 'Levels of 8-isoprostane (biomarker of lipid peroxidation', 'insulin sensitivity via hyperinsulinemic euglycemic clamp', 'insulin sensitivity and cardiovascular risk factors including vascular reactivity, blood pressure, resting metabolic rate, glucose tolerance, lipid profiles, and oxidative stress biomarkers', 'insulin sensitivity and other cardiovascular risk factors', 'levels of triglyceride']","[{'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0151671', 'cui_str': 'Glucose tolerance decreased'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0453273', 'cui_str': 'Cranberry preparation'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0295541', 'cui_str': '8-isoprostaglandin F2alpha'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0023775', 'cui_str': 'Lipid peroxidation'}, {'cui': 'C0079318', 'cui_str': 'Euglycaemic Clamp'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C4082350', 'cui_str': 'Resting Metabolic Rate'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}]",,0.644559,"Levels of 8-isoprostane (biomarker of lipid peroxidation) decreased in the cranberry group but increased in the placebo group (-2.18 pg/mL vs +20.81 pg/mL, p=0.02).","[{'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Hsia', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA70808, USA.'}, {'ForeName': 'Derek J', 'Initials': 'DJ', 'LastName': 'Zhang', 'Affiliation': 'Ocean Spray Cranberries, Inc., Lakeville-Middleboro, MA02349, USA.'}, {'ForeName': 'Robbie S', 'Initials': 'RS', 'LastName': 'Beyl', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA70808, USA.'}, {'ForeName': 'Frank L', 'Initials': 'FL', 'LastName': 'Greenway', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA70808, USA.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Khoo', 'Affiliation': 'Ocean Spray Cranberries, Inc., Lakeville-Middleboro, MA02349, USA.'}]",The British journal of nutrition,['10.1017/S0007114520001336']
282,32304555,Is Carbon Dioxide Insufflation During Endoscopy in Children as Safe and as Effective as We Think?,"OBJECTIVES


Distension of the gastrointestinal lumen is crucial for visualization and advancement during endoscopic procedures. An increasing number of pediatric centers now use carbon dioxide (CO2) preferentially over air as many adult studies and a few pediatric studies have concluded that CO2 is better tolerated than air, especially for colonoscopy.
AIMS


The aim of the study was to determine if CO2 is as safe and as effective as air and if it reduces abdominal discomfort and distension in children undergoing upper endoscopy and colonoscopy.
METHODS


Double blinded, prospective, randomized clinical study. Patient- and nursing-reported outcomes of pain and distension were recorded. End tidal CO2 (EtCO2) was monitored continuously with a CO2-sampling nasal cannula for patients undergoing procedural sedation and via the endotracheal tube for those who were intubated.
RESULTS


One hundred seventy-eight patients with 180 procedures were enrolled, 91 procedures were randomized to receive CO2, and 89 to air. Groups did not differ significantly with respect to nursing-assessed abdominal discomfort, change in girth from baseline, or endoscopist-perceived ease of inflation. Use of CO2 was associated with transient spikes in the EtCO2 (≥60 mmHg) in a significant number of patients during sedated upper endoscopy without endotracheal intubation. There was a reduction of bloating and flatulence for all procedures in the CO2 group.
CONCLUSIONS


The benefits of using CO2 for insufflation were minimal in our patients. The observed transient elevations of EtCO2 during sedated upper endoscopy raise concerns of possible systemic hypercarbia. The wisdom of its routine use for all pediatric endoscopic procedures is questioned.",2020,"Groups did not differ significantly with respect to nursing-assessed abdominal discomfort, change in girth from baseline, or endoscopist-perceived ease of inflation.","['178 patients with 180 procedures were enrolled, 91 procedures', 'children undergoing upper endoscopy and colonoscopy']","['carbon dioxide (CO2', 'CO2-sampling nasal cannula', 'Carbon Dioxide Insufflation', 'CO2']","['pain and distension', 'End tidal CO2 (EtCO2', 'bloating and flatulence', 'nursing-assessed abdominal discomfort, change in girth from baseline, or endoscopist-perceived ease of inflation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0017195', 'cui_str': 'Endoscopy of stomach'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}]","[{'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannulae'}, {'cui': 'C0021634', 'cui_str': 'Insufflation'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C3267130', 'cui_str': 'End-tidal CO2'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0232487', 'cui_str': 'Abdominal discomfort'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0021398', 'cui_str': 'Economic Inflation'}]",178.0,0.0923888,"Groups did not differ significantly with respect to nursing-assessed abdominal discomfort, change in girth from baseline, or endoscopist-perceived ease of inflation.","[{'ForeName': 'Chinenye R', 'Initials': 'CR', 'LastName': 'Dike', 'Affiliation': 'Division of Pediatric Gastroenterology, Hepatology, Pancreatology and Nutrition, Stead Family Department of Pediatrics, University of Iowa, Iowa City, IA.'}, {'ForeName': 'Riad', 'Initials': 'R', 'LastName': 'Rahhal', 'Affiliation': 'Division of Pediatric Gastroenterology, Hepatology, Pancreatology and Nutrition, Stead Family Department of Pediatrics, University of Iowa, Iowa City, IA.'}, {'ForeName': 'Warren P', 'Initials': 'WP', 'LastName': 'Bishop', 'Affiliation': 'Division of Pediatric Gastroenterology, Hepatology, Pancreatology and Nutrition, Stead Family Department of Pediatrics, University of Iowa, Iowa City, IA.'}]",Journal of pediatric gastroenterology and nutrition,['10.1097/MPG.0000000000002724']
283,32303373,Effectiveness of a hand hygiene program to reduce acute gastroenteritis at child care centers: A cluster randomized trial.,"We aimed to assess the effectiveness of an educational and hand hygiene program in daycare centers (DCCs) and homes on acute gastroenteritis (AGE) incidence in children attending DCCs.
METHODS


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


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


This study demonstrated that hand hygiene programs that included hand sanitizer were most effective in the winter months. Further, the largest reduction of AGE episodes occurred in the children that followed hand hygiene programs including hand sanitizer and educational measures for DCC staff, parents, and children, and were vaccinated for rotavirus.",2020,"A multivariate model was applied and the adjusted incidence rate ratios by rotavirus vaccination found significant differences when children were previously vaccinated, the children in the soap and water group had a higher risk of AGE episodes (incidence rate ratio: 1.28, 95% confidence interval:1.0-1.64), compared with those in the HSG.
","['acute gastroenteritis at child care centers', '911 children aged 0-3 years attending 24 DCCs in Almería (Spain) with an 8-month follow-up was employed', 'daycare centers (DCCs) and homes on acute gastroenteritis (AGE) incidence in children attending DCCs']","['DCCs families performed educational and hand hygiene measures, 1 with soap and water (soap and water group; n\u202f=\u202f274), another with hand sanitizer (hand sanitizer group [HSG]; n\u202f=\u202f339), and the control group (CG; n\u202f=\u202f298) followed usual handwashing procedures', 'hand hygiene program', 'educational and hand hygiene program']","['risk of AGE episodes', 'AGE episodes']","[{'cui': 'C0267446', 'cui_str': 'Acute gastroenteritis'}, {'cui': 'C0008070', 'cui_str': 'Child day care center'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]","[{'cui': 'C0008070', 'cui_str': 'Child day care center'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C3494474', 'cui_str': 'Hand Hygiene'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0037392', 'cui_str': 'Soap'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1330330', 'cui_str': 'Hand Antiseptics'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0267446', 'cui_str': 'Acute gastroenteritis'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}]",911.0,0.0530918,"A multivariate model was applied and the adjusted incidence rate ratios by rotavirus vaccination found significant differences when children were previously vaccinated, the children in the soap and water group had a higher risk of AGE episodes (incidence rate ratio: 1.28, 95% confidence interval:1.0-1.64), compared with those in the HSG.
","[{'ForeName': 'Ernestina', 'Initials': 'E', 'LastName': 'Azor-Martinez', 'Affiliation': 'Andalusian Deparment of Health, Distrito Sanitario de Atención Primaria, Almería, Spain. Electronic address: eazorm@yahoo.es.'}, {'ForeName': 'Llenalia', 'Initials': 'L', 'LastName': 'Garcia-Fernandez', 'Affiliation': 'Deparment of Bioestadistica, SEPLIN, Soluciones Estadísticas, Granada, Spain.'}, {'ForeName': 'Jenna Marie', 'Initials': 'JM', 'LastName': 'Strizzi', 'Affiliation': 'Department of Public Health, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Maria Dolores', 'Initials': 'MD', 'LastName': 'Cantarero-Vallejo', 'Affiliation': 'Castilla-La Mancha Deparment of Health, Centro de salud de Illescas, Toledo, Spain.'}, {'ForeName': 'Carmen Pilar', 'Initials': 'CP', 'LastName': 'Jimenez-Lorente', 'Affiliation': 'Andalusian Deparment of Health, Distrito Sanitario de Atención Primaria, Almería, Spain.'}, {'ForeName': 'Josep Vicent', 'Initials': 'JV', 'LastName': 'Balaguer-Martinez', 'Affiliation': 'Cantalan Deparment of Health, CAP St Ildefons, Cornellà de Llobregat, Barcelona, Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Torres-Alegre', 'Affiliation': 'Andalusian Deparment of Health, Distrito Sanitario de Atención Primaria, Almería, Spain.'}, {'ForeName': 'Romy', 'Initials': 'R', 'LastName': 'Yui-Hifume', 'Affiliation': 'Andalusian Deparment of Pediatrics, Servicio de Pediatría, Hospital Torrecárdenas, Almería, Spain.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Sanchez-Forte', 'Affiliation': 'Andalusian Deparment of Pediatrics, Servicio de Pediatría, Hospital Torrecárdenas, Almería, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Gimenez-Sanchez', 'Affiliation': 'Andalusian Deparment of Pediatrics, Instituto Hispalense de Pediatría, Instituto Balmis de Vacunas, Almeria, Spain.'}]",American journal of infection control,['10.1016/j.ajic.2020.03.011']
284,32300910,A Randomized Controlled Trial of Functional Communication Training via Telehealth for Young Children with Autism Spectrum Disorder.,"Many children with autism spectrum disorder (ASD) have problem behaviors that interfere with learning and social interaction. This randomized controlled trial compared treatment with functional communication training (FCT) to ""treatment as usual"" for young children with ASD (n = 38, ages 21-84 months). FCT was conducted by parents with training and real-time coaching provided by behavioral consultants using telehealth. FCT treatment via telehealth achieved a mean reduction in problem behavior of 98% compared to limited behavioral improvement in children receiving ""treatment as usual"" during a 12-week period. Social communication and task completion also improved. For children with ASD and moderate to severe behavior problems, parent-implemented FCT using telehealth significantly reduced problem behavior while ongoing interventions typically did not.",2020,"FCT treatment via telehealth achieved a mean reduction in problem behavior of 98% compared to limited behavioral improvement in children receiving ""treatment as usual"" during a 12-week period.","['young children with ASD (n\u2009=\u200938, ages 21-84\xa0months', 'Young Children with Autism Spectrum Disorder', 'children with autism spectrum disorder (ASD']","['Functional Communication Training via Telehealth', 'FCT', 'functional communication training (FCT']",['Social communication and task completion'],"[{'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C4708134', 'cui_str': 'Functional communication training'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}]","[{'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]",,0.0709193,"FCT treatment via telehealth achieved a mean reduction in problem behavior of 98% compared to limited behavioral improvement in children receiving ""treatment as usual"" during a 12-week period.","[{'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Lindgren', 'Affiliation': 'Stead Family Department of Pediatrics, University of Iowa College of Medicine, 100 Hawkins Drive, Iowa City, IA, 52242, USA. scott-lindgren@uiowa.edu.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Wacker', 'Affiliation': 'Stead Family Department of Pediatrics, University of Iowa College of Medicine, 100 Hawkins Drive, Iowa City, IA, 52242, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Schieltz', 'Affiliation': 'Stead Family Department of Pediatrics, University of Iowa College of Medicine, 100 Hawkins Drive, Iowa City, IA, 52242, USA.'}, {'ForeName': 'Alyssa', 'Initials': 'A', 'LastName': 'Suess', 'Affiliation': 'Chatter Pediatric Therapy, Williston, ND, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Pelzel', 'Affiliation': 'Department of Psychiatry, University of Iowa College of Medicine, Iowa City, IA, USA.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Kopelman', 'Affiliation': 'Department of Psychiatry, University of Iowa College of Medicine, Iowa City, IA, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Telehealth Behavioral Consultation Services, Sahuarita, AZ, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Romani', 'Affiliation': ""Children's Hospital Colorado, University of Colorado School of Medicine, Aurora, CO, USA.""}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': ""O'Brien"", 'Affiliation': 'Stead Family Department of Pediatrics, University of Iowa College of Medicine, 100 Hawkins Drive, Iowa City, IA, 52242, USA.'}]",Journal of autism and developmental disorders,['10.1007/s10803-020-04451-1']
285,32299106,Maternal and Neonatal Outcomes Associated with Amniotomy among Nulliparous Women Undergoing Labor Induction at Term.,"OBJECTIVE


The aim of the study is to evaluate the association between amniotomy at various time points during labor induction and maternal and neonatal outcomes among term, nulliparous women.
STUDY DESIGN


Secondary analysis of a randomized trial of term labor induction versus expectant management in low-risk, nulliparous women (2014-2017) was conducted. Women met inclusion criteria if they underwent induction ≥38 weeks' gestation using oxytocin with documented time and type of membrane rupture. Women with antepartum stillbirth or fetal anomaly were excluded. The primary outcome was cesarean delivery. Secondary outcomes included maternal and neonatal complications. Maternal and neonatal outcomes were compared among women with amniotomy versus women with intact membranes and no amniotomy at six 2-hour time intervals: before oxytocin initiation, 0 to <2 hours after oxytocin, 2 to <4 hours after, 4 to <6 hours after, 6 to <8 hours after, and 8 to <10 hours after. Multivariable logistic regression adjusted for maternal age, body mass index, race/ethnicity, modified Bishop score on admission, treatment group, and hospital (as a random effect).
RESULTS


Of 6,106 women in the parent trial, 2,854 (46.7%) women met inclusion criteria. Of these 2,340 (82.0%) underwent amniotomy, and majority of the women had amniotomy performed between 2 and <6 hours after oxytocin. Cesarean delivery was less frequent among women with amniotomy 6 to <8 hours after oxytocin compared with women without amniotomy (21.9 vs. 29.7%; adjusted odds ratio 0.61, 95% confidence interval 0.42-0.89). Amniotomy at time intervals ≥4 hours after oxytocin was associated with lower odds of labor duration >24 hours. Amniotomy at time intervals ≥2 hours and <8 hours after oxytocin was associated with lower odds of maternal hospitalization >3 days. Amniotomy was not associated with postpartum or neonatal complications.
CONCLUSION


Among a contemporary cohort of nulliparous women undergoing term labor induction, amniotomy was associated with either lower or similar odds of cesarean delivery and other adverse outcomes, compared with no amniotomy.",2020,Amniotomy at time intervals ≥4 hours after oxytocin was associated with lower odds of labor duration >24 hours.,"['nulliparous women undergoing term labor induction', 'nulliparous women', 'Women with antepartum stillbirth or fetal anomaly were excluded', '6,106 women in the parent trial, 2,854 (46.7%) women met inclusion criteria', 'Nulliparous Women Undergoing Labor Induction at Term', 'low-risk, nulliparous women (2014-2017']","['oxytocin', 'labor induction versus expectant management']","['Cesarean delivery', 'maternal and neonatal complications', 'cesarean delivery', 'Maternal and neonatal outcomes']","[{'cui': 'C0425979', 'cui_str': 'Nulliparous'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0259787', 'cui_str': 'Induction of labor'}, {'cui': 'C3831525', 'cui_str': 'Antepartum stillbirth'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0259787', 'cui_str': 'Induction of labor'}, {'cui': 'C0700325', 'cui_str': 'Patient status observation'}]","[{'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",6106.0,0.17579,Amniotomy at time intervals ≥4 hours after oxytocin was associated with lower odds of labor duration >24 hours.,"[{'ForeName': 'Ashley N', 'Initials': 'AN', 'LastName': 'Battarbee', 'Affiliation': 'Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Grecio', 'Initials': 'G', 'LastName': 'Sandoval', 'Affiliation': 'Department of Obstetrics and Gynecology, The George Washington University Biostatistics Center, Washington, District of Columbia.'}, {'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Grobman', 'Affiliation': 'Department of Obstetrics and Gynecology, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Uma M', 'Initials': 'UM', 'LastName': 'Reddy', 'Affiliation': 'The Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.'}, {'ForeName': 'Alan T N', 'Initials': 'ATN', 'LastName': 'Tita', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Silver', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Utah Health Sciences Center, Salt Lake City, Utah.'}, {'ForeName': 'Yasser Y', 'Initials': 'YY', 'LastName': 'El-Sayed', 'Affiliation': 'Department of Obstetrics and Gynecology, Stanford University, Stanford, California.'}, {'ForeName': 'Ronald J', 'Initials': 'RJ', 'LastName': 'Wapner', 'Affiliation': 'Department of Obstetrics and Gynecology, Columbia University, New York, New York.'}, {'ForeName': 'Dwight J', 'Initials': 'DJ', 'LastName': 'Rouse', 'Affiliation': 'Department of Obstetrics and Gynecology, Brown University, Providence, Rhode Island.'}, {'ForeName': 'George R', 'Initials': 'GR', 'LastName': 'Saade', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Texas Medical Branch, Galveston, Texas.'}, {'ForeName': 'Suneet P', 'Initials': 'SP', 'LastName': 'Chauhan', 'Affiliation': ""Department of Obstetrics and Gynecology, University of Texas Health Science Center at Houston-Children's Memorial Hermann Hospital, Houston, Texas.""}, {'ForeName': 'Jay D', 'Initials': 'JD', 'LastName': 'Iams', 'Affiliation': 'Department of Obstetrics and Gynecology, The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Edward K', 'Initials': 'EK', 'LastName': 'Chien', 'Affiliation': 'Department of Obstetrics and Gynecology, MetroHealth Medical Center-Case Western Reserve University, Cleveland, Ohio.'}, {'ForeName': 'Brian M', 'Initials': 'BM', 'LastName': 'Casey', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Ronald S', 'Initials': 'RS', 'LastName': 'Gibbs', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Colorado School of Medicine, Anschutz Medical Campus, Aurora, Colorado.'}, {'ForeName': 'Sindhu K', 'Initials': 'SK', 'LastName': 'Srinivas', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Geeta K', 'Initials': 'GK', 'LastName': 'Swamy', 'Affiliation': 'Department of Obstetrics and Gynecology, Duke University, Durham, North Carolina.'}, {'ForeName': 'Hyagriv N', 'Initials': 'HN', 'LastName': 'Simhan', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of perinatology,['10.1055/s-0040-1709464']
286,32302693,"Evaluation of febuxostat initiation during an acute gout attack: A prospective, randomized clinical trial.","OBJECTIVE


Urate-lowering treatment (ULT) is recommended in gout management. However, initiation of ULT during an acute gout flare is still inconclusive. This study aimed to evaluate the efficacy and safety of the ULT febuxostat administered at initiation of an acute gout attack.
METHODS


A prospective randomized controlled clinical trial was conducted for 12 weeks in primary gout patients who were admitted with acute gout attacks. Subjects were randomly assigned to the febuxostat group in which febuxostat, 40mg daily, was administered in the primary care setting for attacks, or to the control group in which febuxostat, 40mg daily, was administered after the attacks. All patients received adequate anti-inflammatory and analgesic therapies. Serum urate (SU) levels were monitored throughout the study. Pain, measured using a visual analogue scale (VAS), and gout recurrence rate were used as primary outcomes. Flare-related inflammation biomarkers were selected as secondary outcomes.
RESULTS


Fifty-two patients completed the study (febuxostat group: n=28; control group: n=24). No significant differences were detected in VAS scores between the two groups over the first 14-day observation period (P>0.05). Administration of febuxostat decreased SU levels significantly during the first 2-week period. However, the gout recurrent rate or gout flare-related inflammation indicators did not change in the febuxostat or control groups. Treatment-related adverse events were mild and similar between groups.
CONCLUSION


Initiation of the urate-lowering drug febuxostat during an acute gout attack caused no significant difference in daily pain, recurrent flares, or adverse effects. The treatment significantly decreased SU levels in the early stage and might have potential long-term benefits in these patients.",2020,No significant differences were detected in VAS scores between the two groups over the first 14-day observation period (P > 0.05).,"['Fifty-two patients completed the study (febuxostat group: n = 28; control group: n = 24', 'Acute Gout Attack', '12 weeks in primary gout patients who were admitted with acute gout attacks']","['control group in which febuxostat', 'adequate anti-inflammatory and analgesic therapies', 'Febuxostat Initiation', 'ULT', 'febuxostat', 'febuxostat group in which febuxostat', 'Urate-lowering treatment (ULT', 'ULT febuxostat']","['adverse events', 'SU levels', 'gout recurrent rate or gout flare-related inflammation indicators', 'daily pain, recurrent flares, or adverse effects', 'Flare-related inflammation biomarkers', 'efficacy and safety', 'Serum urate (SU) levels', 'Pain, measured using a visual analogue scale (VAS), and gout recurrence rate', 'VAS scores']","[{'cui': 'C4319570', 'cui_str': '52'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0249529', 'cui_str': 'febuxostat'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0149896', 'cui_str': 'Primary gout'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0249529', 'cui_str': 'febuxostat'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C0412784', 'cui_str': 'Analgesic technique'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0202239', 'cui_str': 'Uric acid measurement'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0455272', 'cui_str': 'Serum urate measurement'}, {'cui': 'C0018099', 'cui_str': 'Gout'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0149896', 'cui_str': 'Primary gout'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0202239', 'cui_str': 'Uric acid measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",52.0,0.111008,No significant differences were detected in VAS scores between the two groups over the first 14-day observation period (P > 0.05).,"[{'ForeName': 'Ruixia', 'Initials': 'R', 'LastName': 'Sun', 'Affiliation': 'Shandong Provincial Key Laboratory of Metabolic Diseases and Qingdao Key Laboratory of Gout, Department of Endocrinology and Metabolism, the Affiliated Hospital of Qingdao University, 266003 Qingdao, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': 'Shandong Provincial Key Laboratory of Metabolic Diseases and Qingdao Key Laboratory of Gout, Department of Endocrinology and Metabolism, the Affiliated Hospital of Qingdao University, 266003 Qingdao, China; Institute of Metabolic Diseases, Qingdao University, 266003 Qingdao, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Shandong Provincial Key Laboratory of Metabolic Diseases and Qingdao Key Laboratory of Gout, Department of Endocrinology and Metabolism, the Affiliated Hospital of Qingdao University, 266003 Qingdao, China.'}, {'ForeName': 'Xiaoyu', 'Initials': 'X', 'LastName': 'Cheng', 'Affiliation': 'Shandong Provincial Key Laboratory of Metabolic Diseases and Qingdao Key Laboratory of Gout, Department of Endocrinology and Metabolism, the Affiliated Hospital of Qingdao University, 266003 Qingdao, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Xin', 'Affiliation': 'Shandong Provincial Key Laboratory of Metabolic Diseases and Qingdao Key Laboratory of Gout, Department of Endocrinology and Metabolism, the Affiliated Hospital of Qingdao University, 266003 Qingdao, China.'}, {'ForeName': 'Changgui', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Shandong Provincial Key Laboratory of Metabolic Diseases and Qingdao Key Laboratory of Gout, Department of Endocrinology and Metabolism, the Affiliated Hospital of Qingdao University, 266003 Qingdao, China; Institute of Metabolic Diseases, Qingdao University, 266003 Qingdao, China. Electronic address: lichanggui@medmail.com.cn.'}]",Joint bone spine,['10.1016/j.jbspin.2020.03.017']
287,32302009,"Randomized study of the effect of gadopiclenol, a new gadolinium-based contrast agent, on the QTc interval in healthy subjects.","AIMS


We investigated the effect of gadopiclenol, a new gadolinium-based contrast agent, on the QTc interval at clinical and supraclinical dose, considering the relative hyperosmolarity of this product.
METHODS


This was a single centre, randomized, double-blind, placebo- and positive-controlled, 4-way crossover study. Forty-eight healthy male and female subjects were included to receive single intravenous (i.v.) administrations of gadopiclenol at the clinical dose of 0.1 mmol kg -1  , standard for current gadolinium-based contrast agents, the supraclinical dose of 0.3 mmol kg -1  , placebo and a single oral dose of 400 mg moxifloxacin.
RESULTS


The largest time-matched placebo-corrected, mean change from-baseline in QTcF (ΔΔQTcF) was observed 3 hours after administration of 0.1 mmol kg -1  gadopiclenol (2.39 ms, 90% confidence interval [CI]: 0.35, 4.43 ms) and 5 minutes after administration of 0.3 mmol kg -1  (4.81 ms, 90%CI: 2.84, 6.78 ms). The upper limit of the 90% CI was under the threshold of 10 ms, demonstrating no significant effect of gadopiclenol on QTc interval. From 1.5 to 4 hours postdose moxifloxacin, the lower limit of the 90% CI of ΔΔQTcF exceeded 5 ms demonstrating assay sensitivity. Although there was a positive slope, the concentration-response analysis estimated that the values of ΔΔQTcF at the maximal concentration of gadopiclenol at 0.1 and 0.3 mmol kg -1  were 0.41 and 2.23 ms, respectively, with the upper limit of the 90% CI not exceeding 10 ms. No serious or severe adverse events or treatment discontinuations due to adverse events were reported.
CONCLUSION


This thorough QT/QTc study demonstrated that gadopiclenol did not prolong the QT interval at clinical and supraclinical doses and was well tolerated in healthy volunteers. The positive slope of the QTc prolongation vs concentration relationship suggests that hyperosmolarity could be associated with QTc prolongation. However, the amplitude of this effects is unlikely to be associated with proarrhythmia.",2020,"No serious or severe adverse events or treatment discontinuations due to adverse events were reported.
","['healthy volunteers', 'healthy subjects', 'Forty-eight healthy male and female subjects']","['gadopiclenol', 'gadopiclenol, a new gadolinium-based contrast agent', 'moxifloxacin', 'placebo', 'QTcF']","['QT interval', 'No serious or severe adverse events', 'QTc interval']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0016911', 'cui_str': 'Gadolinium'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0536495', 'cui_str': 'moxifloxacin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0429028', 'cui_str': 'QT interval feature'}, {'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}, {'cui': 'C0860814', 'cui_str': 'QTc'}]",48.0,0.124577,"No serious or severe adverse events or treatment discontinuations due to adverse events were reported.
","[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Funck-Brentano', 'Affiliation': 'INSERM, CIC-1901 and UMRS 1166, Paris, France; AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology and CIC-1901, Paris, France; Sorbonne Université Médecine, Paris, France; Institute of Cardiometabolism and Nutrition (ICAN), Paris, France.'}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Felices', 'Affiliation': 'Phinc, Massy, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Le Fur', 'Affiliation': 'Guerbet, Roissy CDG Cedex, France.'}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Dubourdieu', 'Affiliation': 'Guerbet, Roissy CDG Cedex, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Desché', 'Affiliation': 'Guerbet, Roissy CDG Cedex, France.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Vanhoutte', 'Affiliation': 'SGS Clinical Pharmacology Unit, ZNA Stuivenberg, Antwerp, Belgium.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Voiriot', 'Affiliation': 'Cardiabase, Nancy, France.'}]",British journal of clinical pharmacology,['10.1111/bcp.14309']
288,32298501,High-protein meals require 30% additional insulin to prevent delayed postprandial hyperglycaemia.,"AIM


To determine the amount of additional insulin required for a high-protein meal to prevent postprandial hyperglycaemia in individuals with type 1 diabetes using insulin pump therapy.
METHODS


In this randomized cross-over study, 26 participants aged 8-40 years, HbA 1c  < 65 mmol/mol (8.1%), received a 50 g protein, 30 g carbohydrate, low-fat (< 1 g) breakfast drink over five consecutive days at home. A standard insulin dose (100%) was compared with additional doses of 115, 130, 145 and 160% for the protein, in randomized order. Doses were commenced 15-min pre-drink and delivered over 3 h using a combination bolus with 65% of the standard dose given up front. Postprandial glycaemia was assessed by 4 h of continuous glucose monitoring.
RESULTS


The 100% dosing resulted in postprandial hyperglycaemia. From 120 min, ≥ 130% doses resulted in significantly lower postprandial glycaemic excursions compared with 100% (P < 0.05). A 130% dose produced a mean (sd) glycaemic excursion that was 4.69 (2.42) mmol/l lower than control, returning to baseline by 4 h (P < 0.001). From 120 min, there was a significant increase in the risk of hypoglycaemia compared with control for 145% [odds ratio (OR) 25.4, 95% confidence interval (CI) 5.5-206; P < 0.001) and 160% (OR 103, 95% CI 19.2-993; P < 0.001). Some 81% (n = 21) of participants experienced hypoglycaemia following a 160% dose, whereas 58% (n = 15) experienced hypoglycaemia following a 145% dose. There were no hypoglycaemic events reported with 130%.
CONCLUSIONS


The addition of 30% more insulin to a standard dose for a high-protein meal, delivered using a combination bolus, improves postprandial glycaemia without increasing the risk of hypoglycaemia.",2020,"From 120 min, ≥ 130% doses resulted in significantly lower postprandial glycaemic excursions compared with 100% (P < 0.05).","['26 participants aged 8-40\xa0years, HbA 1c  <\xa065\xa0mmol/mol (8.1%), received a 50\xa0g protein', 'individuals with type 1 diabetes']","['30\xa0g carbohydrate, low-fat (<\xa01\xa0g) breakfast drink']","['risk of hypoglycaemia', 'postprandial hyperglycaemia', 'mean (sd) glycaemic excursion', 'Postprandial glycaemia', 'hypoglycaemia', 'delayed postprandial hyperglycaemia', 'postprandial glycaemic excursions', 'postprandial glycaemia', 'hypoglycaemic events']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}, {'cui': 'C4517875', 'cui_str': '8.1'}, {'cui': 'C0086376', 'cui_str': 'G protein'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0242970', 'cui_str': 'Low fat diet'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C0452428', 'cui_str': 'Drink'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C1855520', 'cui_str': 'Postprandial Hyperglycemia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",26.0,0.433075,"From 120 min, ≥ 130% doses resulted in significantly lower postprandial glycaemic excursions compared with 100% (P < 0.05).","[{'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Paterson', 'Affiliation': ""Department of Paediatric Endocrinology and Diabetes, John Hunter Children's Hospital, Newcastle, Australia.""}, {'ForeName': 'C E M', 'Initials': 'CEM', 'LastName': 'Smart', 'Affiliation': ""Department of Paediatric Endocrinology and Diabetes, John Hunter Children's Hospital, Newcastle, Australia.""}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Howley', 'Affiliation': 'School of Mathematical and Physical Sciences/Statistics, The University of Newcastle, Rankin Park, New South Wales, Australia.'}, {'ForeName': 'D A', 'Initials': 'DA', 'LastName': 'Price', 'Affiliation': 'Pacific Private Clinic, Gold Coast, Australia.'}, {'ForeName': 'D C', 'Initials': 'DC', 'LastName': 'Foskett', 'Affiliation': 'Insulin Pump Angels, Gold Coast, Australia.'}, {'ForeName': 'B R', 'Initials': 'BR', 'LastName': 'King', 'Affiliation': ""Department of Paediatric Endocrinology and Diabetes, John Hunter Children's Hospital, Newcastle, Australia.""}]",Diabetic medicine : a journal of the British Diabetic Association,['10.1111/dme.14308']
289,32296727,Does Intensive Treatment Select for Praziquantel Resistance in High-Transmission Settings? Parasitological Trends and Treatment Efficacy Within a Cluster-Randomized Trial.,"Background


Praziquantel mass drug administration (MDA) is recommended in schistosomiasis-endemic areas. Animal models demonstrate  Schistosoma  parasite resistance to praziquantel after repeated exposure.
Methods


We conducted a parasitological survey in 26 fishing communities in Uganda after 4 years of quarterly (13 communities) or annual (13 communities) praziquantel MDA, with  Schistosoma  infection detected by single-stool-sample Kato-Katz. A test of cure was done in participants who were positive on both urine circulating cathodic antigen test and 3-sample Kato-Katz. We calculated cure rates (CRs) and egg reduction rates (ERRs) based on 3-sample Kato-Katz and infection intensity using worm-specific circulating anodic antigen (CAA) in blood, comparing these between quarterly and annually treated participants.
Results


Single-sample Kato-Katz  Schistosoma mansoni  prevalence was 22% in 1,056 quarterly treated participants and 34% in 1,030 annually treated participants (risk ratio, 0.62; 95% confidence interval [CI], 0.40 to 0.94). Among 110 test-of-cure participants, CRs were 65% and 51% in annually and quarterly treated villages, respectively (odds ratio, 0.65; 95% CI, 0.27 to 1.58); ERRs were 94% and 81% (difference, -13%; 95% CI, -48% to 2%). There was no impact of quarterly vs annual praziquantel on  S. mansoni  by CAA.
Conclusions


In this schistosomiasis hot spot, there was little evidence of decreased praziquantel efficacy. However, in the absence of alternative therapies, there remains a need for continued vigilance of praziquantel efficacy in the MDA era.",2020,"Schistosoma mansoni  prevalence was 22% in 1,056 quarterly treated participants and 34% in 1,030 annually treated participants (risk ratio, 0.62; 95% confidence interval [CI], 0.40 to 0.94).","['schistosomiasis-endemic areas', '26 fishing communities in Uganda after 4 years of quarterly (13 communities) or annual (13 communities) praziquantel MDA, with  Schistosoma  infection detected by single-stool-sample Kato-Katz', 'participants who were positive on both urine circulating cathodic antigen test and 3-sample Kato-Katz']",['\n\n\nPraziquantel mass drug administration (MDA'],"['Parasitological Trends and Treatment Efficacy', 'Schistosoma mansoni  prevalence', 'cure rates (CRs) and egg reduction rates (ERRs) based on 3-sample Kato-Katz and infection intensity using worm-specific circulating anodic antigen (CAA', 'CRs', 'praziquantel efficacy']","[{'cui': 'C0036323', 'cui_str': 'Disease due to Schistosomatidae'}, {'cui': 'C0243130', 'cui_str': 'endemics'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332179', 'cui_str': 'Trimonthly'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0032911', 'cui_str': 'Praziquantel'}, {'cui': 'C4505223', 'cui_str': 'Mass Administration'}, {'cui': 'C0036315', 'cui_str': 'Schistosoma'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C1550661', 'cui_str': 'Stool specimen'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0729856', 'cui_str': 'Antigen test'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0032911', 'cui_str': 'Praziquantel'}, {'cui': 'C4505223', 'cui_str': 'Mass Administration'}]","[{'cui': 'C0205468', 'cui_str': 'Parasitologic'}, {'cui': 'C0040833', 'cui_str': 'trends'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0036319', 'cui_str': 'Schistosoma mansoni'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0013710', 'cui_str': 'Eggs (edible)'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0018889', 'cui_str': 'Helminth infection'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0003320', 'cui_str': 'Antigen'}, {'cui': 'C1842937', 'cui_str': 'Aural Atresia, Congenital'}, {'cui': 'C0010278', 'cui_str': 'Craniosynostosis syndrome'}, {'cui': 'C0032911', 'cui_str': 'Praziquantel'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",1056.0,0.341196,"Schistosoma mansoni  prevalence was 22% in 1,056 quarterly treated participants and 34% in 1,030 annually treated participants (risk ratio, 0.62; 95% confidence interval [CI], 0.40 to 0.94).","[{'ForeName': 'John Vianney', 'Initials': 'JV', 'LastName': 'Tushabe', 'Affiliation': 'Immunomodulation and Vaccines Research Programme, Medical Research Council/Uganda Virus Research Institute and London School of Hygiene and Tropical Medicine Uganda Research Unit, Entebbe, Uganda.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Lubyayi', 'Affiliation': 'Immunomodulation and Vaccines Research Programme, Medical Research Council/Uganda Virus Research Institute and London School of Hygiene and Tropical Medicine Uganda Research Unit, Entebbe, Uganda.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Sserubanja', 'Affiliation': 'Immunomodulation and Vaccines Research Programme, Medical Research Council/Uganda Virus Research Institute and London School of Hygiene and Tropical Medicine Uganda Research Unit, Entebbe, Uganda.'}, {'ForeName': 'Prossy', 'Initials': 'P', 'LastName': 'Kabuubi', 'Affiliation': 'Immunomodulation and Vaccines Research Programme, Medical Research Council/Uganda Virus Research Institute and London School of Hygiene and Tropical Medicine Uganda Research Unit, Entebbe, Uganda.'}, {'ForeName': 'Elson', 'Initials': 'E', 'LastName': 'Abayo', 'Affiliation': 'Immunomodulation and Vaccines Research Programme, Medical Research Council/Uganda Virus Research Institute and London School of Hygiene and Tropical Medicine Uganda Research Unit, Entebbe, Uganda.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Kiwanuka', 'Affiliation': 'Immunomodulation and Vaccines Research Programme, Medical Research Council/Uganda Virus Research Institute and London School of Hygiene and Tropical Medicine Uganda Research Unit, Entebbe, Uganda.'}, {'ForeName': 'Jacent', 'Initials': 'J', 'LastName': 'Nassuuna', 'Affiliation': 'Immunomodulation and Vaccines Research Programme, Medical Research Council/Uganda Virus Research Institute and London School of Hygiene and Tropical Medicine Uganda Research Unit, Entebbe, Uganda.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Kaweesa', 'Affiliation': 'Vector Control Division, Ministry of Health, Kampala, Uganda.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Corstjens', 'Affiliation': 'Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Govert', 'Initials': 'G', 'LastName': 'van Dam', 'Affiliation': 'Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Sanya', 'Affiliation': 'Immunomodulation and Vaccines Research Programme, Medical Research Council/Uganda Virus Research Institute and London School of Hygiene and Tropical Medicine Uganda Research Unit, Entebbe, Uganda.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Ssenyonga', 'Affiliation': 'Immunomodulation and Vaccines Research Programme, Medical Research Council/Uganda Virus Research Institute and London School of Hygiene and Tropical Medicine Uganda Research Unit, Entebbe, Uganda.'}, {'ForeName': 'Edridah Muheki', 'Initials': 'EM', 'LastName': 'Tukahebwa', 'Affiliation': 'Vector Control Division, Ministry of Health, Kampala, Uganda.'}, {'ForeName': 'Narcis B', 'Initials': 'NB', 'LastName': 'Kabatereine', 'Affiliation': 'Vector Control Division, Ministry of Health, Kampala, Uganda.'}, {'ForeName': 'Alison M', 'Initials': 'AM', 'LastName': 'Elliott', 'Affiliation': 'Immunomodulation and Vaccines Research Programme, Medical Research Council/Uganda Virus Research Institute and London School of Hygiene and Tropical Medicine Uganda Research Unit, Entebbe, Uganda.'}, {'ForeName': 'Emily L', 'Initials': 'EL', 'LastName': 'Webb', 'Affiliation': 'MRC Tropical Epidemiology Group, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Open forum infectious diseases,['10.1093/ofid/ofaa091']
290,31600414,Internet-delivered mindfulness-based cognitive therapy for anxiety and depression in cancer survivors: A randomized controlled trial.,"OBJECTIVE


Internet-delivered interventions may alleviate distress in cancer survivors with limited access to psychological face-to-face treatment. In collaboration with a group of cancer survivors, we developed and tested the efficacy of a therapist-assisted internet-delivered mindfulness-based cognitive therapy (iMBCT) program for anxiety and depression in cancer survivors.
METHODS


A total of 1282 cancer survivors were screened for anxiety and depression during their routine oncology follow-up; eligible breast (n = 137) and prostate cancer (n = 13) survivors were randomized to iMBCT or care-as-usual (CAU) wait-list. Primary outcomes of anxiety and depression were assessed at baseline, 5 weeks, 10 weeks (post intervention), and 6 months.
RESULTS


Significant effects were found for both anxiety (Cohen's d = 0.45; P = .017) and depressive symptoms (d = 0.42; P = .024) post intervention. The effects were maintained at follow-up for anxiety (d = 0.40; P = .029), but not for depressive symptoms (d = 0.28; P = .131).
CONCLUSIONS


Our preliminary findings suggest iMBCT to be a helpful intervention for cancer survivors suffering from symptoms of anxiety. Further studies on the efficacy for symptoms of depression are needed.",2020,"RESULTS


Significant effects were found for both anxiety (Cohen's d=0.45; p=0.017) and depressive symptoms (d=0.42; p=0.024) post-intervention.","['1282 cancer survivors were screened for anxiety and depression during their routine oncology follow-up; eligible breast (n=137) and prostate cancer (n=13) survivors', 'cancer survivors suffering from symptoms of anxiety', 'cancer survivors']","['therapist-assisted internet-delivered mindfulness-based cognitive therapy (iMBCT) program', 'iMBCT or CAU-waitlist', 'Internet-delivered Mindfulness-Based Cognitive Therapy', 'iMBCT']","['anxiety and depression', 'depressive symptoms']","[{'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0444892', 'cui_str': 'CAU'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}]",,0.110396,"RESULTS


Significant effects were found for both anxiety (Cohen's d=0.45; p=0.017) and depressive symptoms (d=0.42; p=0.024) post-intervention.","[{'ForeName': 'Eva Rames', 'Initials': 'ER', 'LastName': 'Nissen', 'Affiliation': 'Department of Psychology and Behavioural Sciences, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Maja', 'Initials': 'M', 'LastName': ""O'Connor"", 'Affiliation': 'Department of Psychology and Behavioural Sciences, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Viktor', 'Initials': 'V', 'LastName': 'Kaldo', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, and Stockholm Health Care Services, Stockholm, Sweden.'}, {'ForeName': 'Inger', 'Initials': 'I', 'LastName': 'Højris', 'Affiliation': 'Department of Oncology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Borre', 'Affiliation': 'Department of Urology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Zachariae', 'Affiliation': 'Department of Psychology and Behavioural Sciences, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Mimi', 'Initials': 'M', 'LastName': 'Mehlsen', 'Affiliation': 'Department of Psychology and Behavioural Sciences, Aarhus University, Aarhus, Denmark.'}]",Psycho-oncology,['10.1002/pon.5237']
291,31106486,Saliva cotinine concentrations in pregnant women who smoke and use nicotine patches.,"BACKGROUND AND AIMS


Due to concerns about increased exposure to nicotine, pregnant women using nicotine replacement therapy (NRT) to stop smoking are usually advised to stop using NRT if they relapse to smoking. This study investigated whether this is justified. We compared changes in saliva cotinine from baseline to 2 weeks post-target quit date pregnant smokers who relapsed to smoking and continued to use their patches having been assigned to use nicotine patches or placebo.
DESIGN AND SETTING


Controlled pre-post design stratified by intervention condition from the 'Study of Nicotine Patch in Pregnancy', a randomized, placebo-controlled trial.
PARTICIPANTS


A sample of 268 pregnant women, assigned placebo (n = 122) or nicotine (n = 146) patches, who returned for further supplies of patches and who reported any smoking in the week prior to a visit at 2 weeks after their target quit date.
MEASUREMENTS


Saliva cotinine concentrations were measured at baseline and 2 weeks after participants' target quit dates. Any smoking in the previous week was assessed by self-report, validated by expired air carbon monoxide (CO).
FINDINGS


There was no change in saliva cotinine concentrations between baseline and 2 weeks post-target quit date in saliva cotinine concentration in the nicotine patch group [ratio of geometric means = 0.94, 95% confidence interval (CI) = 0.83 to 1.07; P = 0.37, Bayes factor = 0.15]. However, there was a reduction in reported number of cigarettes smoked/day (mean difference -6, 95% CIs -7 to -5, P < 0.001) and in CO concentrations (mean difference -3.0 parts per million, 95% CIs -4.2 to -1.9, P < 0.001). These changes were not significantly different from changes in the placebo group except for cigarette consumption, which reduced more in the nicotine group (P = 0.046).
CONCLUSIONS


In women trying to stop smoking with the aid of a nicotine patch but having smoked at 2 weeks post-target quit, their nicotine concentration did not change from baseline, but they reported smoking fewer cigarettes and had lower carbon monoxide concentrations.",2019,"There was no change in saliva cotinine concentrations between baseline and 2 weeks post-target quit date in saliva cotinine concentration in the nicotine patch group [ratio of geometric means = 0.94, 95% confidence interval (CI) = 0.83 to 1.07; P = 0.37, Bayes factor = 0.15].","['n\xa0=\xa0122) or', 'A sample of 268 pregnant women, assigned', 'pregnant women using', 'pregnant women who smoke and use nicotine patches']","['nicotine', 'placebo', 'nicotine replacement therapy (NRT', 'Nicotine Patch', 'nicotine patches or placebo']","['saliva cotinine', 'saliva cotinine concentrations', 'cigarette consumption', 'Saliva cotinine concentrations', 'carbon monoxide concentrations', 'saliva cotinine concentration', 'CO concentrations', 'expired air carbon monoxide (CO']","[{'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C4517673', 'cui_str': '268'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0358855', 'cui_str': 'Nicotine Transdermal Patch'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0358855', 'cui_str': 'Nicotine Transdermal Patch'}]","[{'cui': 'C0036087', 'cui_str': 'Saliva (substance)'}, {'cui': 'C0010194', 'cui_str': 'Scotine'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0459840', 'cui_str': 'Cigarette consumption (observable entity)'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0001861', 'cui_str': 'Air'}]",268.0,0.428942,"There was no change in saliva cotinine concentrations between baseline and 2 weeks post-target quit date in saliva cotinine concentration in the nicotine patch group [ratio of geometric means = 0.94, 95% confidence interval (CI) = 0.83 to 1.07; P = 0.37, Bayes factor = 0.15].","[{'ForeName': 'Ravinder', 'Initials': 'R', 'LastName': 'Claire', 'Affiliation': 'Division of Primary Care, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Coleman', 'Affiliation': 'Division of Primary Care, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Leonardi-Bee', 'Affiliation': 'Division of Epidemiology and Public Health, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Berlin', 'Affiliation': 'Département de pharmacologie, Hôpital Pitié-Salpêtrière, Paris, France.'}]","Addiction (Abingdon, England)",['10.1111/add.14662']
292,31701593,"Activated clotting time on the day of atrial fibrillation ablation for minimally interrupted and uninterrupted direct oral anticoagulation therapy: Sequential changes, differences among direct oral anticoagulants, and ablation safety outcomes.","BACKGROUND


Activated clotting time (ACT)-guided heparinization is used during atrial fibrillation (AF) ablation. Differences in sensitivity to ACT assays have been identified among different direct oral anticoagulants (DOACs).
OBJECTIVE


We aimed to examine ACT just before ablation (pre-ACT) for different ablation start times (9:00, 11:00, 13:00, or 15:00) and ablation safety outcomes in minimally interrupted (min-Int) and uninterrupted (Unint) DOAC regimens and examine differences in pre-ACT values among four DOACs.
METHODS


Consecutive patients were randomized into the min-Int (n = 307) or Unint (n = 277) groups. DOACs examined were apixaban, dabigatran, edoxaban, and rivaroxaban.
RESULTS


No sequential changes in pre-ACT values were observed for each DOAC used and for all four DOACs combined in the min-Int and Unint groups. There was no meaningful difference in pre-ACT at each ablation start time between the groups. Clinically significant differences in overall pre-ACT were not obtained between the groups (138 ± 24 vs 142 ± 23 seconds). The pre-ACT (baseline) value for dabigatran was on average 29 seconds higher than that for the other three DOACs. The min-Int and Unint groups showed similar thromboembolic (0% vs 0%) and bleeding event rates (major, 1% vs 0%; all, 3.5% vs 2.5%).
CONCLUSION


The pre-ACT did not show a sequential change in the min-Int and Unint groups. No notable differences in the time-dependent change in pre-ACT between the groups were observed. Variations in baseline ACT suggest the need for moderate adjustment of ACT for adequate modification of heparin dose for the other three DOACs. Both regimens provided similar acceptable AF ablation safety outcomes.",2019,Clinically significant differences in overall pre-ACT were not obtained between the groups (138±24 vs 142±23 s).,['Consecutive patients were randomized into the min-Int (n=307) or Unint (n=277) groups'],"['apixaban, dabigatran, edoxaban']","['bleeding event rates', 'similar thromboembolic', 'ablation safety outcomes', 'pre-ACT values', 'overall pre-ACT', 'time-dependent change in pre-ACT']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C1831808', 'cui_str': 'apixaban'}, {'cui': 'C2348066', 'cui_str': 'dabigatran'}, {'cui': 'C2975435', 'cui_str': 'edoxaban'}]","[{'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",,0.0288874,Clinically significant differences in overall pre-ACT were not obtained between the groups (138±24 vs 142±23 s).,"[{'ForeName': 'Hirosuke', 'Initials': 'H', 'LastName': 'Yamaji', 'Affiliation': 'Heart Rhythm Center, Okayama Heart Clinic, Okayama, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Murakami', 'Affiliation': 'Heart Rhythm Center, Okayama Heart Clinic, Okayama, Japan.'}, {'ForeName': 'Kazuyoshi', 'Initials': 'K', 'LastName': 'Hina', 'Affiliation': 'Heart Rhythm Center, Okayama Heart Clinic, Okayama, Japan.'}, {'ForeName': 'Shunich', 'Initials': 'S', 'LastName': 'Higashiya', 'Affiliation': 'Heart Rhythm Center, Okayama Heart Clinic, Okayama, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Kawamura', 'Affiliation': 'Heart Rhythm Center, Okayama Heart Clinic, Okayama, Japan.'}, {'ForeName': 'Masaaki', 'Initials': 'M', 'LastName': 'Murakami', 'Affiliation': 'Heart Rhythm Center, Okayama Heart Clinic, Okayama, Japan.'}, {'ForeName': 'Shigeshi', 'Initials': 'S', 'LastName': 'Kamikawa', 'Affiliation': 'Heart Rhythm Center, Okayama Heart Clinic, Okayama, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Hirohata', 'Affiliation': 'Department of Medical Technology, Graduate School of Health Sciences, Okayama University, Okayama, Japan.'}, {'ForeName': 'Shozo', 'Initials': 'S', 'LastName': 'Kusachi', 'Affiliation': 'Department of Medical Technology, Graduate School of Health Sciences, Okayama University, Okayama, Japan.'}]",Journal of cardiovascular electrophysiology,['10.1111/jce.14260']
293,31640990,Using telemedicine to support care for people with type 2 diabetes mellitus: a qualitative analysis of patients' perspectives.,"OBJECTIVE


Telemedicine has been promoted as an economical and effective way to enhance patient care, but its acceptance among patients in low-income and middle-income countries is poorly understood. This study is aimed to explore the experiences and perspectives of people with type 2 diabetes mellitus that used telemedicine to manage their condition.
DESIGN


In-depth and focus group interviews were conducted with participants who have engaged in telemedicine. Questions included were participants' perception on the programme being used, satisfaction as well as engagement with the telemedicine programme. All interviews and focus groups were audio-recorded and transcribed verbatim. Data were analysed using a thematic approach.
PARTICIPANTS AND SETTING


People with type 2 diabetes (n=48) who participated in a randomised controlled study which examined the use of telemedicine for diabetes management were recruited from 11 primary care clinics located within the Klang Valley.
RESULTS


Twelve focus groups and two in-depth interviews were conducted. Four themes emerged from the analysis: (1) generational difference; (2) independence and convenience, (3) sharing of health data and privacy and (4) concerns and challenges. The main obstacles found in patients using the telemedicine systems were related to internet connectivity and difficulties experienced with system interface. Cost was also another significant concern raised by participants. Participants in this study were primarily positive about the benefits of telemedicine, including its ability to provide real-time data and disease monitoring and the reduction in clinic visits.
CONCLUSION


Despite the potential benefits of telemedicine in the long-term care of diabetes, there are several perceived barriers that may limit the effectiveness of this technology. As such, collaboration between educators, healthcare providers, telecommunication service providers and patients are required to stimulate the adoption and the use of telemedicine.NCT0246680.",2019,"Participants in this study were primarily positive about the benefits of telemedicine, including its ability to provide real-time data and disease monitoring and the reduction in clinic visits.
","['for diabetes management were recruited from 11 primary care clinics located within the Klang Valley', 'participants who have engaged in telemedicine', 'people with type 2 diabetes mellitus', 'People with type 2 diabetes (n=48) who participated']",['telemedicine'],"['generational difference; (2) independence and convenience, (3) sharing of health data and privacy and (4) concerns and challenges']","[{'cui': 'C1552443', 'cui_str': 'Primary care clinic (environment)'}, {'cui': 'C0563004', 'cui_str': 'Valley (environment)'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0080048', 'cui_str': 'Privacy'}]",,0.0655066,"Participants in this study were primarily positive about the benefits of telemedicine, including its ability to provide real-time data and disease monitoring and the reduction in clinic visits.
","[{'ForeName': 'Jun Yang', 'Initials': 'JY', 'LastName': 'Lee', 'Affiliation': 'School of Pharmacy, Monash University - Malaysia Campus, Bandar Sunway, Malaysia.'}, {'ForeName': 'Carina Ka Yee', 'Initials': 'CKY', 'LastName': 'Chan', 'Affiliation': 'La Trobe University College of Science Health and Engineering, Bundoora, Victoria, Australia.'}, {'ForeName': 'Siew Siang', 'Initials': 'SS', 'LastName': 'Chua', 'Affiliation': ""School of Pharmacy, Taylor's University - Lakeside Campus, Subang Jaya, Malaysia.""}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Paraidathathu', 'Affiliation': ""School of Pharmacy, Taylor's University - Lakeside Campus, Subang Jaya, Malaysia.""}, {'ForeName': 'Kenneth Kwing-Chin', 'Initials': 'KK', 'LastName': 'Lee', 'Affiliation': 'School of Pharmacy, Monash University - Malaysia Campus, Bandar Sunway, Malaysia.'}, {'ForeName': 'Christina San San', 'Initials': 'CSS', 'LastName': 'Tan', 'Affiliation': 'HELP International Corporation Bhd, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Nazrila', 'Initials': 'N', 'LastName': 'Nasir', 'Affiliation': 'Kementerian Kesihatan Malaysia, Putrajaya, Malaysia.'}, {'ForeName': 'Shaun Wen Huey', 'Initials': 'SWH', 'LastName': 'Lee', 'Affiliation': 'School of Pharmacy, Monash University - Malaysia Campus, Bandar Sunway, Malaysia shaun.lee@monash.edu.'}]",BMJ open,['10.1136/bmjopen-2018-026575']
294,27481188,A nonrandomized cohort and a randomized study of local control of large hepatocarcinoma by targeting intratumoral lactic acidosis.,"Background


Previous works suggested that neutralizing intratumoral lactic acidosis combined with glucose deprivation may deliver an effective approach to control tumor. We did a pilot clinical investigation, including a nonrandomized (57 patients with large HCC) and a randomized controlled (20 patients with large HCC) study.
Methods


The patients were treated with transarterial chemoembolization (TACE) with or without bicarbonate local infusion into tumor.
Results


In the nonrandomized controlled study, geometric mean of viable tumor residues (VTR) in TACE with bicarbonate was 6.4-fold lower than that in TACE without bicarbonate (7.1% [95% CI: 4.6%–10.9%] vs 45.6% [28.9%–72.0%]; p<0.0001). This difference was recapitulated by a subsequent randomized controlled study. TACE combined with bicarbonate yielded a 100% objective response rate (ORR), whereas the ORR treated with TACE alone was 44.4% (nonrandomized) and 63.6% (randomized). The survival data suggested that bicarbonate may bring survival benefit.
Conclusions


Bicarbonate markedly enhances the anticancer activity of TACE.
Funding


Funded by National Natural Science Foundation of China.
Clinical trial number


ChiCTR-IOR-14005319.",2016,"TACE combined with bicarbonate yielded a 100% objective response rate (ORR), whereas the ORR treated with TACE alone was 44.4% (nonrandomized) and 63.6% (randomized).",['57 patients with large HCC) and a randomized controlled (20 patients with large HCC) studies'],"['TACE', 'TACE combined with bicarbonate', 'transarterial chemoembolization (TACE) with or without bicarbonate local infusion into tumor', 'bicarbonate', 'Bicarbonate']","['objective response rate (ORR', 'geometric mean of viable tumor residues (VTR']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0529196', 'cui_str': 'ADAM-17 Protein'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0005367', 'cui_str': 'Hydrogen Carbonates'}, {'cui': 'C0522522', 'cui_str': 'Transarterial approach (qualifier value)'}, {'cui': 'C0796679', 'cui_str': 'Chemoembolization'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}]","[{'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443348', 'cui_str': 'Viable (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}]",57.0,0.122403,"TACE combined with bicarbonate yielded a 100% objective response rate (ORR), whereas the ORR treated with TACE alone was 44.4% (nonrandomized) and 63.6% (randomized).","[{'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Chao', 'Affiliation': 'Department of Radiology, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'Cancer Institute, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Jin', 'Affiliation': 'Department of Radiology, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': 'Department of Radiology, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Jianjun', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Radiology, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Guangqiang', 'Initials': 'G', 'LastName': 'Zhang', 'Affiliation': 'Department of Radiology, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Gong', 'Initials': 'G', 'LastName': 'Yang', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, United States.'}, {'ForeName': 'Xun', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'Cancer Institute, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China.'}]",eLife,['10.7554/eLife.15691']
295,31961963,A randomized controlled study of the efficacy of tadalafil monotherapy versus combination of tadalafil and mirabegron for the treatment of persistent overactive bladder symptoms in men presenting with lower urinary tract symptoms (CONTACT Study).,"AIM


To evaluate efficacy and safety of combination of tadalafil + mirabegron for overactive bladder/benign prostatic hyperplasia (OAB/BPH).
METHODS


Male patients with lower urinary tract symptoms (50 to 89 years), with remaining OAB symptoms even after administering tadalafil for more than 8 weeks were randomly assigned to either tadalafil monotherapy group (5 mg/day) or tadalafil/mirabegron combination therapy group (5 mg/50 mg/day). The primary endpoint was change from baseline in total OAB symptom score (OABSS) at week 12. The secondary endpoints were changes in International Prostate Symptom Score (IPSS), NIH-chronic prostatitis symptom index (NIH-CPSI), and micturition chart parameters at weeks 4 and 12.
RESULTS


A total of 176 patients were randomized to either monotherapy (87 patients) or combination therapy (89 patients). The baseline characteristics of patients in the two groups were similar. The total OABSS (95% confidence interval) of combination therapy was significantly decreased by 1.78 (1.05-2.50) points compared with that of monotherapy (P < .001). Changes from baseline in OABSS nighttime voiding score, urgency score, urgency incontinence score, IPSS storage subscores, NIH-CPSI total score, and numbers of voids, nighttime-voids, and urgency episodes/day in micturition chart were significantly reduced in combination therapy (all P < .001). Patient-reported outcome was significantly more satisfactory in combination therapy than in monotherapy (P < .001). One moderate adverse event (pain in hip joint) with hardly presumed causal relationship with therapy and seven mild adverse events were noted in monotherapy and combination therapy group, respectively.
CONCLUSIONS


The effect of tadalafil/mirabegron combination therapy on relieving OAB symptoms appeared to be greater than that of tadalafil monotherapy and can be safely used.",2020,Patient-reported outcome was significantly more satisfactory in combination therapy than in monotherapy (P < .001).,"['176 patients', 'overactive bladder/benign prostatic hyperplasia (OAB/BPH', 'men presenting with lower urinary tract symptoms (CONTACT Study', 'Male patients with lower urinary tract symptoms (50 to 89 years), with remaining OAB symptoms even after administering tadalafil for more than 8 weeks']","['tadalafil\u2009+\u2009mirabegron', 'monotherapy', 'tadalafil monotherapy', 'tadalafil/mirabegron combination therapy', 'combination therapy', 'tadalafil and mirabegron']","['total OAB symptom score (OABSS', 'total OABSS', 'OABSS nighttime voiding score, urgency score, urgency incontinence score, IPSS storage subscores, NIH-CPSI total score, and numbers of voids, nighttime-voids, and urgency episodes/day in micturition chart', 'mild adverse events', 'International Prostate Symptom Score (IPSS), NIH-chronic prostatitis symptom index (NIH-CPSI), and micturition chart parameters', 'relieving OAB symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0878773', 'cui_str': 'Overactive Bladder'}, {'cui': 'C1704272', 'cui_str': 'Benign Prostatic Hyperplasia'}, {'cui': 'C0005001', 'cui_str': 'Benign enlargement of prostate'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0574785', 'cui_str': 'Lower Urinary Tract Symptoms'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C1176316', 'cui_str': 'tadalafil'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C1176316', 'cui_str': 'tadalafil'}, {'cui': 'C2983812', 'cui_str': 'mirabegron'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0021167', 'cui_str': 'Incontinence (finding)'}, {'cui': 'C1698986', 'cui_str': 'Storage (procedure)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0430970', 'cui_str': 'Urinary frequency volume chart (procedure)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1998280', 'cui_str': 'International prostate symptom score (assessment scale)'}, {'cui': 'C0085696', 'cui_str': 'Chronic prostatitis (disorder)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1301771', 'cui_str': 'Relieved'}]",176.0,0.199862,Patient-reported outcome was significantly more satisfactory in combination therapy than in monotherapy (P < .001).,"[{'ForeName': 'Tomonori', 'Initials': 'T', 'LastName': 'Yamanishi', 'Affiliation': 'Department of Urology, Continence Center, Dokkyo Medical University, Tochigi, Japan.'}, {'ForeName': 'Kanya', 'Initials': 'K', 'LastName': 'Kaga', 'Affiliation': 'Department of Urology, Continence Center, Dokkyo Medical University, Tochigi, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Sakata', 'Affiliation': 'Department of Urology, Imaichi Hospital, Tochigi, Japan.'}, {'ForeName': 'Teruhiko', 'Initials': 'T', 'LastName': 'Yokoyama', 'Affiliation': 'Yokoyama Urological Clinic, Okayama, Japan.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Kageyama', 'Affiliation': 'Kageyama Urology Clinic, Shizuoka, Japan.'}, {'ForeName': 'Miki', 'Initials': 'M', 'LastName': 'Fuse', 'Affiliation': 'Department of Urology, Continence Center, Dokkyo Medical University, Tochigi, Japan.'}, {'ForeName': 'Shoji', 'Initials': 'S', 'LastName': 'Tokunaga', 'Affiliation': 'Medical Information Center, Kyushu University Hospital, Fukuoka, Japan.'}]",Neurourology and urodynamics,['10.1002/nau.24285']
296,31702120,Autologous cord blood cell infusion in preterm neonates safely reduces respiratory support duration and potentially preterm complications.,"Preterm birth and its complications are the leading cause of neonatal death. The main underlying pathological mechanisms for preterm complications are disruption of the normal maturation processes within the target tissues, interrupted by premature birth. Cord blood, as a new and convenient source of stem cells, may provide new, promising options for preventing preterm complications. This prospective, nonrandomized placebo controlled study aimed at investigating the effect of autologous cord blood mononuclear cells (ACBMNC) for preventing preterm associated complications. Preterm infants less than 35 weeks gestational age were assigned to receive ACBMNC (5 × 10 7  cells/kg) intravenous or normal saline within 8 hours after birth. Preterm complication rates were compared between two groups to demonstrate the effect of ACBMNC infusion in reducing preterm complications. Fifteen preterm infants received ACBMNC infusion, and 16 infants were assigned to the control group. There were no significant differences when comparing mortality and preterm complication rates before discharge. However, ACBMNC infusion demonstrated significant decreases in duration of mechanical ventilation (3.2 days vs 6.41 days, P = .028) and oxygen therapy (5.33 days vs 11.31 days, P = .047). ACBMNC infusion was effective in reducing respiratory support duration in very preterm infants. Due to the limited number of patients enrolled, powered randomized controlled trials are needed to better define its efficacy.",2020,"However, ACBMNC infusion demonstrated significant decreases in duration of mechanical ventilation (3.2 days vs 6.41 days, P = .028) and oxygen therapy (5.33 days vs 11.31 days, P = .047).","['Preterm infants less than 35\u2009weeks gestational age', 'very preterm infants', 'Fifteen preterm infants received']","['ACBMNC (5\u2009×\u200910 7  cells/kg) intravenous or normal saline', 'Autologous cord blood cells infusion', 'autologous cord blood mononuclear cells (ACBMNC', 'placebo', 'ACBMNC', 'ACBMNC infusion']","['respiratory support duration', 'mortality and preterm complications rate', 'preterm complications', 'Preterm complications rate', 'duration of mechanical ventilation']","[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C3897192', 'cui_str': 'Very preterm infant'}]","[{'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0162371', 'cui_str': 'Cord Blood'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}]",,0.435342,"However, ACBMNC infusion demonstrated significant decreases in duration of mechanical ventilation (3.2 days vs 6.41 days, P = .028) and oxygen therapy (5.33 days vs 11.31 days, P = .047).","[{'ForeName': 'Zhuxiao', 'Initials': 'Z', 'LastName': 'Ren', 'Affiliation': ""Department of Neonatology, Guangdong Women and Children Hospital, Guangzhou Medical University, Guangzhou, People's Republic of China.""}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Xu', 'Affiliation': ""Department of Neonatology, Guangdong Women and Children Hospital, Guangzhou Medical University, Guangzhou, People's Republic of China.""}, {'ForeName': 'Xiaoling', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ""Department of Neonatology, Guangdong Women and Children Hospital, Guangzhou Medical University, Guangzhou, People's Republic of China.""}, {'ForeName': 'Chunyi', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': ""Department of Neonatology, Guangdong Women and Children Hospital, Guangzhou Medical University, Guangzhou, People's Republic of China.""}, {'ForeName': 'Jiayu', 'Initials': 'J', 'LastName': 'Miao', 'Affiliation': ""Department of Neonatology, Guangdong Women and Children Hospital, Guangzhou Medical University, Guangzhou, People's Republic of China.""}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Xia', 'Affiliation': ""Department of Neonatology, Guangdong Women and Children Hospital, Guangzhou Medical University, Guangzhou, People's Republic of China.""}, {'ForeName': 'Mengmeng', 'Initials': 'M', 'LastName': 'Kang', 'Affiliation': ""Department of Neonatology, Guangdong Women and Children Hospital, Guangzhou Medical University, Guangzhou, People's Republic of China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wei', 'Affiliation': ""Guangdong Cord Blood and Stem Cell Bank, Guangzhou, People's Republic of China.""}, {'ForeName': 'Tianbao', 'Initials': 'T', 'LastName': 'Ma', 'Affiliation': ""Guangdong Cord Blood and Stem Cell Bank, Guangzhou, People's Republic of China.""}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': ""Department of Clinical Genetic Center, Guangdong Women and Children Hospital, Guangzhou Medical University, Guangzhou, People's Republic of China.""}, {'ForeName': 'Lijuan', 'Initials': 'L', 'LastName': 'Lu', 'Affiliation': ""Department of Obstetrics, Guangdong Women and Children Hospital, Guangzhou Medical University, Guangzhou, People's Republic of China.""}, {'ForeName': 'Jiying', 'Initials': 'J', 'LastName': 'Wen', 'Affiliation': ""Department of Obstetrics, Guangdong Women and Children Hospital, Guangzhou Medical University, Guangzhou, People's Republic of China.""}, {'ForeName': 'Guocheng', 'Initials': 'G', 'LastName': 'Liu', 'Affiliation': ""Department of Obstetrics, Guangdong Women and Children Hospital, Guangzhou Medical University, Guangzhou, People's Republic of China.""}, {'ForeName': 'Kaiyan', 'Initials': 'K', 'LastName': 'Liu', 'Affiliation': ""Institute of Hematology, People's Hospital, Peking University, Beijing, People's Republic of China.""}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': ""Department of Neonatology, Guangdong Women and Children Hospital, Guangzhou Medical University, Guangzhou, People's Republic of China.""}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': ""Department of Neonatology, Guangdong Women and Children Hospital, Guangzhou Medical University, Guangzhou, People's Republic of China.""}]",Stem cells translational medicine,['10.1002/sctm.19-0106']
297,31358922,Progression and new onset of macular retinoschisis in myopic choroidal neovascularization eyes after Conbercept therapy: a post-hoc analysis.,"OBJECTIVES


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


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


At baseline, 28 of 122 eyes in study group and 10 of 38 eyes in control group had MRS. At month 3, two patients showed MRS progression and one patient had new onset MRS in study group. No MRS progression nor new onset MRS was found in the control group. At final visit, the cumulative incidence of MRS was 1.3% (2/160). Both Spearman's correlation and multiple logistic regression demonstrated no association between the progression and new onset of MRS and intravitreal injection frequency (correlation coefficient = 0.017, P = 0.851 and odds ratio = 0.996, P = 0.982). In addition, baseline vitreoretinal adhesion was the most likely potential risk factor resulting in MRS progression (odds ratio = 4.566, P = 0.027). Furthermore, MRS progression was more likely to take place in outer retinal layers.
CONCLUSIONS


The progression and new onset of MRS was not associated with the frequency of intravitreal Conbercept injections.",2020,No MRS progression nor new onset MRS was found in the control group.,"['myopic choroidal neovascularization eyes after Conbercept therapy', '160 mCNV patients included in SHINY study', 'for myopic choroidal neovascularization (mCNV', 'patients with mCNV undergoing intravitreal Conbercept injections']","['Conbercept injection on MRS', 'intravitreal Conbercept injections']","['MRS', 'cumulative incidence of MRS', 'progression and new onset of MRS and intravitreal injection frequency', 'MRS progression nor new\xa0onset MRS', 'MRS progression', 'new onset MRS']","[{'cui': 'C3665926', 'cui_str': 'Myopic choroidal neovascularization'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C2352201', 'cui_str': 'KH902 fusion protein'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C2352201', 'cui_str': 'KH902 fusion protein'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}, {'cui': 'C1554888', 'cui_str': 'Intravitreal Injections'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}]",,0.0474506,No MRS progression nor new onset MRS was found in the control group.,"[{'ForeName': 'Yanping', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': ""Department of Ophthalmology, Shanghai General Hospital (Shanghai First People's Hospital), Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Shiqi', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': ""Department of Ophthalmology, Shanghai General Hospital (Shanghai First People's Hospital), Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Yuanzhi', 'Initials': 'Y', 'LastName': 'Yuan', 'Affiliation': 'Department of Ophthalmology, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Minlu', 'Initials': 'M', 'LastName': 'Song', 'Affiliation': ""Department of Ophthalmology, Shanghai General Hospital (Shanghai First People's Hospital), Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Fenglei', 'Initials': 'F', 'LastName': 'Kuang', 'Affiliation': 'R&D Center, Chengdu Kanghong Biotech Ltd., Sichuan, China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Liu', 'Affiliation': ""Department of Ophthalmology, Shanghai General Hospital (Shanghai First People's Hospital), Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': 'Department of Ophthalmology, Beijing Tongren Hospital, Capital Medical University, Peking, China.'}, {'ForeName': 'Fenghua', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': ""Department of Ophthalmology, Shanghai General Hospital (Shanghai First People's Hospital), Shanghai Jiao Tong University School of Medicine, Shanghai, China. shretina@sjtu.edu.cn.""}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': ""Department of Ophthalmology, Shanghai General Hospital (Shanghai First People's Hospital), Shanghai Jiao Tong University School of Medicine, Shanghai, China. xdsun@sjtu.edu.cn.""}]","Eye (London, England)",['10.1038/s41433-019-0516-x']
298,31324862,Effects of neuromuscular blockade reversal on bispectral index and frontal electromyogram during steady-state desflurane anesthesia: a randomized trial.,"The degree of neuromuscular blockade reversal may affect bispectral index (BIS) value. One possible reason is that the reverse of neuromuscular blockade affects electromyographic (EMG) signals of fascial muscle. Another reason is, the afferentation theory, the reverse of neuromuscular blockade relieves block signals generated in muscle stretch receptors from accessing the brain through afferent nerve pathways and induces arousal. Inaccurate BIS value may lead to overdose of drugs or the risk of intraoperative awareness. We compared changes in BIS and EMG values according to neuromuscular blockade reversal agents under steady-state desflurane anesthesia. A total of 65 patients were randomly allocated to receive either neostigmine 0.05 mg/kg, sugammadex 4 mg/kg, or pyridostigmine 0.25 mg/kg for neuromuscular blockade reversal under stable desflurane anesthesia, and 57 patients completed the study. The primary outcome was change in BIS and EMG values before and after administration of neuromuscular blockade reversal agents (between train-of-four [TOF] count 1-2 and TOF ratio 0.9). The change in BIS and EMG values before and after administration of neuromuscular blockade reversal agents were statistically different in each group (BIS: Neostigmine group, P < 0.001; Sugammadex group, P < 0.001; Pyridostigmine group, P = 0.001; EMG: Neostigmine group, P = 0.001; Sugammadex group, P < 0.001; Pyridostigmine group, P = 0.001; respectively). The BIS and EMG values had a positive correlation (P < 0.001). Our results demonstrate that the EMG and BIS values have increased after neuromuscular blockade reversal under desflurane anesthesia regardless of the type of neuromuscular blockade reversal agent. BIS should be applied carefully to measure of depth of anesthesia after neuromuscular blockade reversal.",2019,"The change in BIS and EMG values before and after administration of neuromuscular blockade reversal agents were statistically different in each group (BIS: Neostigmine group, P < 0.001; Sugammadex group, P < 0.001; Pyridostigmine group, P = 0.001; EMG: Neostigmine group, P = 0.001; Sugammadex group, P < 0.001; Pyridostigmine group, P = 0.001; respectively).","['A total of 65 patients', 'steady-state desflurane anesthesia']","['Neostigmine', 'neostigmine 0.05\u2009mg/kg, sugammadex 4\u2009mg/kg, or pyridostigmine 0.25\u2009mg/kg for neuromuscular blockade reversal under stable desflurane anesthesia', 'neuromuscular blockade reversal', 'Pyridostigmine']","['BIS and EMG values', 'bispectral index and frontal electromyogram', 'change in BIS and EMG values', 'bispectral index (BIS) value']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205361', 'cui_str': 'Steady (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0063252', 'cui_str': 'desflurane'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}]","[{'cui': 'C0027679', 'cui_str': 'Neostigmine'}, {'cui': 'C4517411', 'cui_str': '0.05'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C1700695', 'cui_str': 'Sugammadex'}, {'cui': 'C0034261', 'cui_str': 'Pyridostigmine'}, {'cui': 'C4517443', 'cui_str': '0.25 (qualifier value)'}, {'cui': 'C0412773', 'cui_str': 'Reversal of neuromuscular blockade (procedure)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0063252', 'cui_str': 'desflurane'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}]","[{'cui': 'C1872096', 'cui_str': 'bis(phenylacetylarginine)'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1301882', 'cui_str': 'Bispectral index'}, {'cui': 'C0205123', 'cui_str': 'Coronal (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",65.0,0.164583,"The change in BIS and EMG values before and after administration of neuromuscular blockade reversal agents were statistically different in each group (BIS: Neostigmine group, P < 0.001; Sugammadex group, P < 0.001; Pyridostigmine group, P = 0.001; EMG: Neostigmine group, P = 0.001; Sugammadex group, P < 0.001; Pyridostigmine group, P = 0.001; respectively).","[{'ForeName': 'Doyeon', 'Initials': 'D', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Jin Hee', 'Initials': 'JH', 'LastName': 'Ahn', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Hyunjoo', 'Initials': 'H', 'LastName': 'Jung', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Ka Young', 'Initials': 'KY', 'LastName': 'Choi', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Ji Seon', 'Initials': 'JS', 'LastName': 'Jeong', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea. jiseon78.jeong@samsung.com.'}]",Scientific reports,['10.1038/s41598-019-47047-1']
299,32297352,Palliative care for rare advanced lung diseases in underserved Appalachia: Study protocol for a randomized controlled trial.,"AIM


To pilot test a home end-of-life and palliative care intervention for family caregivers and patients with rare advanced lung diseases and to estimate effect-size for the power analysis in a future clinical trial.
DESIGN


This study uses a parallel randomized control trial. Families are randomly assigned to the intervention group or the control group in a 1:1 fashion.
METHODS


The study population includes patients with rare advanced lung diseases and their family caregivers who are involved in patients' home care. The control group receives standard care through their hospital or outpatient clinics. The intervention group receives standard care plus 2-weekly home end-of-life and palliative care coaching by experienced community nurses. Primary outcome is breathlessness measured by shortness of breath scale. Secondary outcomes are: (a) caregivers' anxiety and depression measures; (b) the presence of patient's signed advance directives in the medical record or not; and (c) Helpfulness of intervention measured by self-report Helpfulness scale. The study was funded in October 2018 and received ethical Institutional Review Board approval in February 2019.
DISCUSSION


West Virginia has one of the highest incidence rates of lung disease deaths in the nation. However, there is inadequate home end-of-life and palliative care for this underserved population. This is an initial interventional study of nurse-led coaching home-based palliative care for rare advanced lung diseases in rural Appalachia. Developing research collaboration with clinicians is essential for enrolment. Enrolment was successful due to regular meetings with pulmonologists who screened patients per the study inclusion criteria in their specialty clinic and made direct referrals to the research assistants. Results of this study will be used in the future trial.
IMPACT


The findings will contribute to the evidence-based home nursing care, planning for family/patient preferences and supportive end-of-life palliative care for managing advanced lung diseases at home.
TRIAL REGISTRATION


ClinicalTrials.gov identifier NCT03813667; registered January 23, 2019. https://clinicaltrials.gov/ct2/show/NCT03813667.",2020,"AIM


To pilot test a home end-of-life and palliative care intervention for family caregivers and patients with rare advanced lung diseases and estimate effect-size for the power analysis in a future clinical trial.
","['rare advanced lung diseases in underserved Appalachia', 'rare advanced lung diseases in rural Appalachia', 'family caregivers and patients with rare advanced lung diseases', 'Enrollment was successful due to regular meetings with pulmonologists who screened patients per the study inclusion criteria in their specialty clinic and made direct referrals to the research assistants', ""patients with rare advanced lung diseases and their family caregivers who are involved in patients' home care""]","['standard care through their hospital or outpatient clinics', 'Palliative care', 'home end-of-life and palliative care intervention', 'nurse-led coaching home-based palliative care', 'standard care plus 2-weekly home end-of-life and palliative care coaching by experienced community nurses']","["" (1) caregivers' anxiety and depression measures; (2) the presence of patient's signed advance directives in the medical record or not; and (3) Helpfulness of intervention measured by self-report Helpfulness scale"", 'breathlessness measured by shortness of breath scale']","[{'cui': 'C0521114', 'cui_str': 'Infrequent'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0024115', 'cui_str': 'Disorder of lung'}, {'cui': 'C0003609', 'cui_str': 'Appalachia'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0556656', 'cui_str': 'Meetings'}, {'cui': 'C0586859', 'cui_str': 'Pulmonologist'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0011327', 'cui_str': 'Dental assistant'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0204977', 'cui_str': 'Home care of patient'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0557521', 'cui_str': 'Community nurse'}]","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0001683', 'cui_str': 'Advance Directives'}, {'cui': 'C0025102', 'cui_str': 'Medical record'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}]",,0.0685488,"AIM


To pilot test a home end-of-life and palliative care intervention for family caregivers and patients with rare advanced lung diseases and estimate effect-size for the power analysis in a future clinical trial.
","[{'ForeName': 'Ubolrat', 'Initials': 'U', 'LastName': 'Piamjariyakul', 'Affiliation': 'School of Nursing, West Virginia University, Morgantown, WV, USA.'}, {'ForeName': 'Angel', 'Initials': 'A', 'LastName': 'Smothers', 'Affiliation': 'School of Nursing, West Virginia University, Morgantown, WV, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Young', 'Affiliation': 'School of Nursing, West Virginia University, Morgantown, WV, USA.'}, {'ForeName': 'Trisha', 'Initials': 'T', 'LastName': 'Petitte', 'Affiliation': 'School of Nursing, West Virginia University, Morgantown, WV, USA.'}, {'ForeName': 'Sijin', 'Initials': 'S', 'LastName': 'Wen', 'Affiliation': 'Department of Biostatistics School of Public Health, West Virginia University, Morgantown, WV, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Morrissey', 'Affiliation': 'School of Nursing, West Virginia University, Morgantown, WV, USA.'}, {'ForeName': 'Saima', 'Initials': 'S', 'LastName': 'Shafique', 'Affiliation': 'Department of Epidemiology School of Public Health, West Virginia University, Morgantown, WV, USA.'}, {'ForeName': 'Rafia', 'Initials': 'R', 'LastName': 'Zulfikar', 'Affiliation': 'Section of Pulmonary, Critical Care, and Sleep Medicine, School of Medicine, West Virginia University, Morgantown, WV, USA.'}, {'ForeName': 'Rahul', 'Initials': 'R', 'LastName': 'Sangani', 'Affiliation': 'Section of Pulmonary, Critical Care, and Sleep Medicine, School of Medicine, West Virginia University, Morgantown, WV, USA.'}, {'ForeName': 'Carol E', 'Initials': 'CE', 'LastName': 'Smith', 'Affiliation': 'School of Nursing and School of Preventive Medicine, University of Kansas Medical Center, Kansas City, KS, USA.'}]",Journal of advanced nursing,['10.1111/jan.14395']
300,31320735,Intravitreal dexamethasone implant as an alternative to systemic steroids as prophylaxis for uveitic cataract surgery: a randomized trial.,"PURPOSE


To determine the utility of the dexamethasone implant (IVD) as an alternative to systemic steroids as prophylaxis against cystoid macular edema (CMO) in patients with chronic, recurrent CMO associated intermediate or posterior uveitis (IU/PU), and cataract undergoing cataract surgery.
METHODS


This was a randomized, parallel design, and clinical trial. Patients with IU/PU and cataract scheduled for cataract surgery were randomly assigned to receive the IVD concurrently with cataract surgery (Group 1: 20 patients) or systemic steroids (Group 2: 23 patients) tapered over 4-6 weeks along with uneventful cataract surgery and routine postoperative care. Patients with glaucoma/contraindications to steroids were excluded. All patients were followed up for 6 months.
OUTCOME MEASURE


Primary-incidence of postoperative CMO. Secondary-the change in BCVA (corrected distance visual acuity) and Central Subfield thickness (CST) and complications. Appropriate statistical analysis was done.
RESULTS


The median age was 47.3 ± 4.23 years (group 1) and 49.12 ± 5.32 years (Group 2). One patient (Group 1) and two (Group 2) developed CMO. The BCVA improved significantly in both groups (p = 0.013). The CST change was insignificant. Four patients (Group 1) required intraocular pressure (IOP) lowering medications. Three patients (Group 2) required early steroid taper.
CONCLUSIONS


IVD is a good alternative as prophylaxis in IU/PU and cataract in preventing postoperative CMO.",2020,The BCVA improved significantly in both groups (p = 0.013).,"['uveitic cataract surgery', 'Patients with IU/PU and cataract scheduled for cataract surgery', 'The median age was 47.3\u2009±\u20094.23 years (group 1) and 49.12\u2009±\u20095.32 years (Group 2', 'Patients with glaucoma/contraindications to steroids were excluded', 'patients with chronic, recurrent CMO associated intermediate or posterior uveitis (IU/PU), and cataract undergoing cataract surgery']","['dexamethasone implant (IVD', 'IVD concurrently with cataract surgery', 'systemic steroids (Group 2: 23 patients) tapered over 4-6 weeks along with uneventful cataract surgery and routine postoperative care', 'Intravitreal dexamethasone implant']","['CMO', 'BCVA', 'postoperative CMO', 'BCVA (corrected distance visual acuity) and Central Subfield thickness (CST) and complications', 'intraocular pressure (IOP) lowering medications']","[{'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0856347', 'cui_str': 'Right cataract'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C2242746', 'cui_str': 'Glaucoma (SMQ)'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to (contextual qualifier) (qualifier value)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0042167', 'cui_str': 'Uveitis, Posterior'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0032786', 'cui_str': 'Postoperative Care'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity (observable entity)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}]",,0.0567074,The BCVA improved significantly in both groups (p = 0.013).,"[{'ForeName': 'Aditya', 'Initials': 'A', 'LastName': 'Sudhalkar', 'Affiliation': 'Raghudeep Eye Hospital and Ila Devi Cataract and IOL Research Centre, Ahmedabad, India. adityasudhalkar@yahoo.com.'}, {'ForeName': 'Abhay', 'Initials': 'A', 'LastName': 'Vasavada', 'Affiliation': 'Raghudeep Eye Hospital and Ila Devi Cataract and IOL Research Centre, Ahmedabad, India.'}, {'ForeName': 'Deepak', 'Initials': 'D', 'LastName': 'Bhojwani', 'Affiliation': 'Raghudeep Eye Hospital and Ila Devi Cataract and IOL Research Centre, Ahmedabad, India.'}, {'ForeName': 'Viraj', 'Initials': 'V', 'LastName': 'Vasavada', 'Affiliation': 'Raghudeep Eye Hospital and Ila Devi Cataract and IOL Research Centre, Ahmedabad, India.'}, {'ForeName': 'Shail', 'Initials': 'S', 'LastName': 'Vasavada', 'Affiliation': 'Raghudeep Eye Hospital and Ila Devi Cataract and IOL Research Centre, Ahmedabad, India.'}, {'ForeName': 'Vaishali', 'Initials': 'V', 'LastName': 'Vasavada', 'Affiliation': 'Raghudeep Eye Hospital and Ila Devi Cataract and IOL Research Centre, Ahmedabad, India.'}, {'ForeName': 'Samaresh', 'Initials': 'S', 'LastName': 'Srivastava', 'Affiliation': 'Raghudeep Eye Hospital and Ila Devi Cataract and IOL Research Centre, Ahmedabad, India.'}]","Eye (London, England)",['10.1038/s41433-019-0534-8']
301,31320738,Relationship between duration and extent of oedema and visual acuity outcome with ranibizumab in diabetic macular oedema: A post hoc analysis of Protocol I data.,"BACKGROUND/OBJECTIVES


This post hoc analysis explores the relationship between residual oedema exposure after ranibizumab treatment initiation and long-term visual acuity outcome in eyes with centre-involved diabetic macular oedema (DMO).
SUBJECTS/METHODS


Eyes randomised to the ranibizumab + prompt or deferred laser treatment arms in the Protocol I trial and with observed central retinal thickness (CRT) readings at baseline and ≥1 follow-up visits (n = 367) were stratified by 1) oedema duration (number of study visits with CRT ≥ 250 µm during the first 52 weeks of ranibizumab treatment); and 2) oedema extent (amount of excess CRT [≥ 250 µm] at each study visit, averaged over the first 52 weeks). Associations between measures of residual oedema and best-corrected visual acuity (BCVA) were assessed in multiple regression analyses.
RESULTS


Oedema duration and oedema extent during the first 52 weeks of ranibizumab treatment showed significant negative associations with BCVA improvement at weeks 52, 104 and 156. Eyes with the most persistent oedema gained (mean) 4.4 (95% CI 0.1─8.7) fewer Early Treatment Diabetic Retinopathy Study (ETDRS) letters at week 156 than eyes with the least persistent oedema (P = 0.044). Eyes with the greatest amount of oedema gained (mean) 9.3 (95% CI 4.0─14.5) fewer ETDRS letters at week 156 than eyes with the least amount of oedema (P < 0.001).
CONCLUSIONS


Macular oedema exposure over the first 52 weeks of ranibizumab treatment is a negative prognostic factor for long-term visual acuity improvement in centre-involved DMO.",2020,"Oedema duration and oedema extent during the first 52 weeks of ranibizumab treatment showed significant negative associations with BCVA improvement at weeks 52, 104 and 156.","['diabetic macular oedema', 'eyes with centre-involved diabetic macular oedema (DMO']","['ranibizumab + prompt or deferred laser treatment', 'ranibizumab']","['oedema and visual acuity outcome', 'residual oedema and best-corrected visual acuity (BCVA', 'Oedema duration and oedema extent', 'ETDRS letters']","[{'cui': 'C0730285', 'cui_str': 'Diabetic macular edema'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}]","[{'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0013604', 'cui_str': 'Hydrops'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439792', 'cui_str': 'Extents (qualifier value)'}, {'cui': 'C1096774', 'cui_str': 'Letter'}]",367.0,0.11728,"Oedema duration and oedema extent during the first 52 weeks of ranibizumab treatment showed significant negative associations with BCVA improvement at weeks 52, 104 and 156.","[{'ForeName': 'Srinivas R', 'Initials': 'SR', 'LastName': 'Sadda', 'Affiliation': 'Doheny Eye Institute, Los Angeles, CA, USA. SSadda@doheny.org.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Campbell', 'Affiliation': 'Allergan plc, Irvine, CA, USA.'}, {'ForeName': 'Pravin U', 'Initials': 'PU', 'LastName': 'Dugel', 'Affiliation': 'Retinal Consultants of Arizona, Phoenix, AZ, USA.'}, {'ForeName': 'Nancy M', 'Initials': 'NM', 'LastName': 'Holekamp', 'Affiliation': 'Pepose Vision Institute and Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Szilárd', 'Initials': 'S', 'LastName': 'Kiss', 'Affiliation': 'Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Anat', 'Initials': 'A', 'LastName': 'Loewenstein', 'Affiliation': 'Department of Ophthalmology, Tel Aviv Medical Center and Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Albert J', 'Initials': 'AJ', 'LastName': 'Augustin', 'Affiliation': 'Department of Ophthalmology, Staedtisches Klinikum Karlsruhe, Karlsruhe, Germany.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Shih', 'Affiliation': 'Allergan plc, Irvine, CA, USA.'}, {'ForeName': 'Xiaoshu', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Allergan plc, Irvine, CA, USA.'}, {'ForeName': 'Charles C', 'Initials': 'CC', 'LastName': 'Wykoff', 'Affiliation': 'Retina Consultants of Houston, Blanton Eye Institute, Houston Methodist Hospital, Houston, TX, USA.'}, {'ForeName': 'Scott M', 'Initials': 'SM', 'LastName': 'Whitcup', 'Affiliation': 'Jules Stein Eye Institute, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA.'}]","Eye (London, England)",['10.1038/s41433-019-0522-z']
302,31324831,Accurate Detection of Dobutamine-induced Haemodynamic Changes by Kino-Cardiography: A Randomised Double-Blind Placebo-Controlled Validation Study.,"Non-invasive remote detection of cardiac and blood displacements is an important topic in cardiac telemedicine. Here we propose kino-cardiography (KCG), a non-invasive technique based on measurement of body vibrations produced by myocardial contraction and blood flow through the cardiac chambers and major vessels. KCG is based on ballistocardiography and measures 12 degrees-of-freedom (DOF) of body motion. We tested the hypothesis that KCG reliably assesses dobutamine-induced haemodynamic changes in healthy subjects. Using a randomized double-blinded placebo-controlled crossover study design, dobutamine and placebo were infused to 34 volunteers (25 ± 2 years, BMI 22 ± 2 kg/m², 18 females). Baseline recordings were followed by 3 sessions of increasing doses of dobutamine (5, 10, 20 μg/kg.min) or saline solution. During each session, stroke volume (SV) and cardiac output (CO) were determined by echocardiography and followed by a 90 s KCG recording. Measured linear accelerations and angular velocities were used to compute total Kinetic energy (iK) and power (Pmax). KCG sorted dobutamine infusion vs. placebo with 96.9% accuracy. Increases in SV and CO were correlated to iK (r = +0.71 and r = +0.8, respectively, p < 0.0001). Kino-cardiography, with 12-DOF, allows detecting dobutamine-induced haemodynamic changes with a high accuracy and present a major improvement over single axis ballistocardiography or seismocardiography.",2019,KCG sorted dobutamine infusion vs. placebo with 96.9% accuracy.,"['healthy subjects', '34 volunteers (25\u2009±\u20092 years, BMI 22\u2009±\u20092\u2009kg/m², 18 females']","['Kino-Cardiography', 'KCG', 'saline solution', 'placebo', 'dobutamine and placebo', 'kino-cardiography (KCG', 'KCG sorted dobutamine infusion vs. placebo', 'Placebo', 'dobutamine']","['SV and CO', 'stroke volume (SV) and cardiac output (CO', 'total Kinetic energy (iK) and power (Pmax']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0012963', 'cui_str': 'Dobutamine'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}]","[{'cui': 'C0038455', 'cui_str': 'Stroke Volume'}, {'cui': 'C0007165', 'cui_str': 'Cardiac Output'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}]",34.0,0.325333,KCG sorted dobutamine infusion vs. placebo with 96.9% accuracy.,"[{'ForeName': 'Amin', 'Initials': 'A', 'LastName': 'Hossein', 'Affiliation': 'LPHYS, Université Libre de Bruxelles, Bruxelles, Belgium. amin.hossein@ulb.ac.be.'}, {'ForeName': 'Daniela Corina', 'Initials': 'DC', 'LastName': 'Mirica', 'Affiliation': 'Department of Cardiology, Erasme Hospital, Université Libre de Bruxelles, Bruxelles, Belgium.'}, {'ForeName': 'Jérémy', 'Initials': 'J', 'LastName': 'Rabineau', 'Affiliation': 'LPHYS, Université Libre de Bruxelles, Bruxelles, Belgium.'}, {'ForeName': 'José Ignacio Del', 'Initials': 'JID', 'LastName': 'Rio', 'Affiliation': 'Department of Cardiology, Erasme Hospital, Université Libre de Bruxelles, Bruxelles, Belgium.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Morra', 'Affiliation': 'Department of Cardiology, Erasme Hospital, Université Libre de Bruxelles, Bruxelles, Belgium.'}, {'ForeName': 'Damien', 'Initials': 'D', 'LastName': 'Gorlier', 'Affiliation': 'LPHYS, Université Libre de Bruxelles, Bruxelles, Belgium.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Nonclercq', 'Affiliation': 'BEAMS, Université Libre de Bruxelles, Bruxelles, Belgium.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'van de Borne', 'Affiliation': 'Department of Cardiology, Erasme Hospital, Université Libre de Bruxelles, Bruxelles, Belgium.'}, {'ForeName': 'Pierre-François', 'Initials': 'PF', 'LastName': 'Migeotte', 'Affiliation': 'LPHYS, Université Libre de Bruxelles, Bruxelles, Belgium.'}]",Scientific reports,['10.1038/s41598-019-46823-3']
303,32297937,Galactose Ingested with a High-Fat Beverage Increases Postprandial Lipemia Compared with Glucose but Not Fructose Ingestion in Healthy Men.,"BACKGROUND


Fructose ingestion with a high-fat beverage increases postprandial lipemia when compared with glucose. It is unknown whether other sugars, such as galactose, also increase postprandial lipemia.
OBJECTIVES


The objective was to assess whether galactose ingestion within a high-fat beverage increases postprandial lipemia relative to glucose or fructose.
METHODS


Two experiments were conducted, which contrasted different test drinks under otherwise standardized conditions. In Experiment 1, 10 nonobese men (age: 22 ± 1 y; BMI, 23.5 ± 2.2 kg/2) ingested either galactose or glucose (0.75 g supplemented carbohydrate per⋅kilogram body mass) within a high-fat test drink (0.94 g fat per kilogram body mass). In Experiment 2, a separate group of 9 nonobese men (age: 26 ± 6 y; BMI: 23.5 ± 2.6 kg/m2) ingested either galactose or fructose (identical doses as those in Experiment 1) within the same high-fat test drink. Capillary blood was sampled before and at frequent intervals after ingestion of the test drinks for a 300-min period to determine plasma triacylglycerol, glucose, lactate, nonesterified fatty acid, and insulin concentrations. Paired t tests and 2-way, repeated-measures ANOVA were used to compare conditions within each experiment.
RESULTS


The incremental AUC for triacylglycerol was greater following galactose ingestion compared with glucose (127 ± 59 compared with 80 ± 48 mmol⋅L-1 × 300 min, respectively; P = 0.04) but not compared with fructose (136 ± 74 compared with 133 ± 63 mmol⋅L-1 ×300 min, respectively; P = 0.91). Plasma lactate concentrations also increased to a greater extent with galactose compared with glucose ingestion (time-condition interaction: P < 0.001) but not fructose ingestion (time-condition interaction: P = 0.17).
CONCLUSIONS


Galactose ingestion within a high-fat beverage exacerbates postprandial lipemia and plasma lactate concentrations compared with glucose but not fructose in nonobese men. These data suggest that galactose metabolism may be more similar to fructose than to glucose, providing a rationale to reassess the metabolic fate of galactose ingestion in humans. This trial was registered at clinicaltrials.gov as NCT03439878.",2020,"Plasma lactate concentrations also increased to a greater extent with galactose compared with glucose ingestion (time-condition interaction: P < 0.001) but not fructose ingestion (time-condition interaction: P = 0.17).
","['10 nonobese men (age: 22\xa0±\xa01 y; BMI, 23.5\xa0±\xa02.2 kg/2) ingested either', 'nonobese men', '9 nonobese men (age: 26\xa0±\xa06 y; BMI: 23.5\xa0±\xa02.6 kg/m2) ingested either', 'Healthy Men']","['galactose or glucose (0.75 g supplemented carbohydrate per⋅kilogram body mass) within a high-fat test drink', 'galactose or fructose (identical doses as those in Experiment 1) within the same high-fat test drink']","['postprandial lipemia relative to glucose or fructose', 'Capillary blood', 'Plasma lactate concentrations', 'incremental AUC for triacylglycerol', 'postprandial lipemia', 'Postprandial Lipemia', 'plasma triacylglycerol, glucose, lactate, nonesterified fatty acid, and insulin concentrations']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C4517633', 'cui_str': '2.6'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}]","[{'cui': 'C0016945', 'cui_str': 'Galactose'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C4068882', 'cui_str': '0.75'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0016745', 'cui_str': 'Fructose'}, {'cui': 'C0205280', 'cui_str': 'Identical'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0020473', 'cui_str': 'Hyperlipidemia'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0016745', 'cui_str': 'Fructose'}, {'cui': 'C0229666', 'cui_str': 'Capillary blood'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}]",2.0,0.0461634,"Plasma lactate concentrations also increased to a greater extent with galactose compared with glucose ingestion (time-condition interaction: P < 0.001) but not fructose ingestion (time-condition interaction: P = 0.17).
","[{'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Watkins', 'Affiliation': 'Department for Health, University of Bath, Bath, United Kingdom.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Simpson', 'Affiliation': 'Institute for Sport, Physical Activity & Leisure, Leeds Beckett University, Leeds, United Kingdom.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Betts', 'Affiliation': 'Department for Health, University of Bath, Bath, United Kingdom.'}, {'ForeName': 'Dylan', 'Initials': 'D', 'LastName': 'Thompson', 'Affiliation': 'Department for Health, University of Bath, Bath, United Kingdom.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Holliday', 'Affiliation': 'Institute for Sport, Physical Activity & Leisure, Leeds Beckett University, Leeds, United Kingdom.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Deighton', 'Affiliation': 'Institute for Sport, Physical Activity & Leisure, Leeds Beckett University, Leeds, United Kingdom.'}, {'ForeName': 'Javier T', 'Initials': 'JT', 'LastName': 'Gonzalez', 'Affiliation': 'Department for Health, University of Bath, Bath, United Kingdom.'}]",The Journal of nutrition,['10.1093/jn/nxaa105']
304,32297992,Severity of Topiramate-Related Working Memory Impairment Is Modulated by Plasma Concentration and Working Memory Capacity.,"Drug side effects that impair cognition can lead to diminished quality of life and discontinuation of therapy. Topiramate is an antiepileptic drug that elicits cognitive deficits more frequently than other antiepileptic drugs, impairing multiple cognitive domains including language, attention, and memory. Although up to 40% of individuals taking topiramate may experience cognitive deficits, we are currently unable to predict which individuals will be most severely affected before administration. The objective of this study was to show the contributions of plasma concentration and working memory capacity in determining the severity of an individual's topiramate-related cognitive impairment. Subjects were enrolled in a double-blind, placebo-controlled crossover study during which they received a single dose of either 100, 150, or 200 mg topiramate. Working memory function was assessed using a modified Sternberg working memory task with 3 memory loads administered 4 hours after dosing. After adjustment for differences in working memory capacity, each 1 μg/mL of topiramate plasma concentration was associated with a 3.6% decrease in accuracy for all memory loads. Placebo effects occurred as a function of working memory capacity, with individuals with high working memory capacity experiencing less severe placebo-related impairment compared with those with low working memory capacity. Our results demonstrate that severity of topiramate-related cognitive deficits occurs as a function of both drug exposure and baseline cognitive function. By identifying patient- and exposure-related characteristics that modulate the severity of cognitive side effects, topiramate dosing strategies may be individually tailored in the future to prevent unwanted cognitive impairment.",2020,"Placebo effects occurred as a function of working memory capacity, with individuals with high working memory capacity experiencing less severe placebo-related impairment compared with those with low working memory capacity.",[],"['Topiramate', 'topiramate', 'Placebo', 'placebo']","['quality of life and discontinuation of therapy', 'function of working memory capacity', 'topiramate plasma concentration']",[],"[{'cui': 'C0076829', 'cui_str': 'topiramate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0076829', 'cui_str': 'topiramate'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.203346,"Placebo effects occurred as a function of working memory capacity, with individuals with high working memory capacity experiencing less severe placebo-related impairment compared with those with low working memory capacity.","[{'ForeName': 'Samuel P', 'Initials': 'SP', 'LastName': 'Callisto', 'Affiliation': 'Experimental and Clinical Pharmacology Department, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Sílvia M', 'Initials': 'SM', 'LastName': 'Illamola', 'Affiliation': 'Experimental and Clinical Pharmacology Department, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Angela K', 'Initials': 'AK', 'LastName': 'Birnbaum', 'Affiliation': 'Experimental and Clinical Pharmacology Department, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Barkley', 'Affiliation': 'Experimental and Clinical Pharmacology Department, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Sai Praneeth R', 'Initials': 'SPR', 'LastName': 'Bathena', 'Affiliation': 'Experimental and Clinical Pharmacology Department, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Ilo E', 'Initials': 'IE', 'LastName': 'Leppik', 'Affiliation': 'Experimental and Clinical Pharmacology Department, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Marino', 'Affiliation': 'Experimental and Clinical Pharmacology Department, University of Minnesota, Minneapolis, Minnesota, USA.'}]",Journal of clinical pharmacology,['10.1002/jcph.1611']
305,32297703,"Safety and efficacy of intrarenal arterial autologous CD34+ cell transfusion in patients with chronic kidney disease: A randomized, open-label, controlled phase II clinical trial.","BACKGROUND


This was a randomized, open-label, controlled phase II clinical trial to investigate the safety, efficacy, and outcomes of intrarenal artery infusion of autologous peripheral-blood-derived CD34+ cells for patients with chronic kidney disease (CKD; ie, stage III or IV).
MATERIALS AND METHODS


Between October 2016 and July 2018, 52 consecutive patients with CKD at stage III or IV were randomly allocated into a treatment group (TG; 2.5 × 10 7  cells for each intrarenal artery; n = 26) and a control group (CG; standardized pharmacotherapy only; n = 26). The primary endpoints included safety and change of creatinine level/creatinine clearance. The secondary endpoints were 12-month combined unfavorable clinical outcomes (defined as dialysis or death), improvement in proteinuria, and CD34+ cell-related adverse events.
RESULTS


All patients were uneventfully discharged after CD34+ cell therapy. The baseline endothelial progenitor cell (EPC) populations did not differ between TG and CG (P > .5). Flow cytometric analysis showed increases in circulating EPC (ie, CD34+KDR+CD45 dim  / CD34+CD133+CD45 dim  /CD31+CD133+CD45 dim  /CD34+CD133+KDR+/CD133+) and hematopoietic stem cell (CD34+) populations after granulocyte-colony stimulating factor treatment (all P < .001). Besides, Matrigel assay of angiogenesis was also significantly enhanced (all P < .001). Renal-venous blood samplings (ie, at 0, 5, 10, and 30 minutes after CD34+ cell infusion) demonstrated significant progressive increases in EPC level (P for trend <.001) among the TG patients. One-year combined unfavorable clinical outcomes were significantly lower in TG than those in CG (0% [0] vs 13.3% [4], P = .038). By 12 months after CD34+ cell therapy, circulating creatinine level, ratio of urine protein to urine creatinine, and creatinine clearance showed no difference between TG and CG (all P > .1).
CONCLUSION


CD34+ cell therapy was safe and improved 1-year outcome.",2020,The baseline endothelial progenitor cell (EPC) populations did not differ between TG and CG (P > .5).,"['Between October 2016 and July 2018, 52 consecutive patients with CKD at stage III or IV', 'patients with chronic kidney disease (CKD; ie, stage III or IV', 'patients with chronic kidney disease']","['CD31+CD133+CD45', 'control group (CG; standardized pharmacotherapy', 'intrarenal arterial autologous CD34+ cell transfusion', 'CD34+CD133+KDR+/CD133', 'CD34+ cell therapy', 'intrarenal artery infusion of autologous peripheral-blood-derived CD34+ cells']","['Safety and efficacy', 'safety and change of creatinine level/creatinine clearance', 'circulating EPC', 'Renal-venous blood samplings', '12-month combined unfavorable clinical outcomes (defined as dialysis or death), improvement in proteinuria, and CD34+ cell-related adverse events', 'EPC level', 'baseline endothelial progenitor cell (EPC) populations', 'Matrigel assay of angiogenesis', 'circulating creatinine level, ratio of urine protein to urine creatinine, and creatinine clearance']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0882849', 'cui_str': 'Cell positive for CD34 antigen'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0201975', 'cui_str': 'Creatinine measurement'}, {'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine'}, {'cui': 'C3850017', 'cui_str': 'Circulating Endothelial Progenitor Cells'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0190979', 'cui_str': 'Phlebotomy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0882849', 'cui_str': 'Cell positive for CD34 antigen'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0065749', 'cui_str': 'matrigel'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0262923', 'cui_str': 'Urine protein test'}, {'cui': 'C1318439', 'cui_str': 'Creatinine measurement, urine'}]",52.0,0.0442942,The baseline endothelial progenitor cell (EPC) populations did not differ between TG and CG (P > .5).,"[{'ForeName': 'Chih-Chao', 'Initials': 'CC', 'LastName': 'Yang', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, Taiwan, Republic of China.'}, {'ForeName': 'Pei-Hsun', 'Initials': 'PH', 'LastName': 'Sung', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, Taiwan, Republic of China.'}, {'ForeName': 'Ben-Chung', 'Initials': 'BC', 'LastName': 'Cheng', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, Taiwan, Republic of China.'}, {'ForeName': 'Yi-Chen', 'Initials': 'YC', 'LastName': 'Li', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, Taiwan, Republic of China.'}, {'ForeName': 'Yi-Ling', 'Initials': 'YL', 'LastName': 'Chen', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, Taiwan, Republic of China.'}, {'ForeName': 'Mel S', 'Initials': 'MS', 'LastName': 'Lee', 'Affiliation': 'Department of Orthopedics, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, Taiwan, Republic of China.'}, {'ForeName': 'Hon-Kan', 'Initials': 'HK', 'LastName': 'Yip', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, Taiwan, Republic of China.'}]",Stem cells translational medicine,['10.1002/sctm.19-0409']
306,32297782,Influence of menthol and green apple e-liquids containing different nicotine concentrations among youth e-cigarette users.,"E-cigarettes are popular among adolescents. Given that flavors enhance e-cigarette appeal, this study examined the influence of flavors on nicotine in e-cigarettes. Youth e-cigarette users (average 26.2 days [SD = 3.6] in past 28 days) were randomized to use e-cigarettes containing 6 or 12 mg/mL of freebase nicotine and completed 4 test sessions. During the first 3 test sessions, participants completed 3 fixed puffing bouts (1 puffing bout = 10 puffs, 3 s each, 30-s interval), using menthol, green-apple, and unflavored e-liquids (50 propylene glycol [PG]/50 vegetable glycerin [VG]) with their assigned nicotine concentration in a random order using a ∼5.5-W V2 e-cigarette device. After each puffing bout, participants assessed subjective effects of nicotine and flavor. In the 4th test session, participants used any of the e-liquids they had tried in the earlier sessions, ad libitum for 60 min and the amount of e-liquid used for each flavor and the number of puffs was assessed. Participants (n = 49; 6 mg/mL [n = 24]; 12 mg/mL [n = 25]) were 63.3% male, 65.3% non-Hispanic White with an average age of 18.7 (SD = 0.9). Mixed models analysis revealed that green apple and 6 mg/mL of nicotine independently increased liking of e-cigarette taste. In addition, green apple produced higher ratings of fruitiness, sourness, sweetness, and menthol produced higher ratings of coolness. We did not observe any interactions between nicotine and flavor. Youth liked the taste of e-liquids containing green-apple flavor or low nicotine concentration which highlights the appeal of fruit flavors in e-cigarettes to adolescents. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,Mixed models analysis revealed that green apple and 6 mg/mL of nicotine independently increased liking of e-cigarette taste.,"['Youth e-cigarette users (average 26.2 days [SD = 3.6] in past 28 days', 'n = 25]) were 63.3% male, 65.3% non-Hispanic White with an average age of 18.7 (SD = 0.9', 'youth e-cigarette users']","['e-cigarettes containing 6 or 12 mg/mL of freebase nicotine', 'nicotine', 'menthol, green-apple, and unflavored e-liquids (50 propylene glycol [PG]/50 vegetable glycerin [VG]) with their assigned nicotine concentration', 'menthol and green apple e-liquids']",['liking of e-cigarette taste'],"[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C4505216', 'cui_str': 'Electronic cigarette user'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4517694', 'cui_str': '3.6'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4068881', 'cui_str': '0.9'}]","[{'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0439294', 'cui_str': 'g/L'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0025368', 'cui_str': 'Menthol'}, {'cui': 'C0332583', 'cui_str': 'Green color'}, {'cui': 'C0003625', 'cui_str': 'Malus'}, {'cui': 'C4543628', 'cui_str': 'Electronic cigarette liquid'}, {'cui': 'C0033437', 'cui_str': 'Propanediols'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0017861', 'cui_str': 'Glycerin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]","[{'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}, {'cui': 'C0039336', 'cui_str': 'Finding of sense of taste'}]",,0.0546791,Mixed models analysis revealed that green apple and 6 mg/mL of nicotine independently increased liking of e-cigarette taste.,"[{'ForeName': 'Asti', 'Initials': 'A', 'LastName': 'Jackson', 'Affiliation': 'Department of Psychiatry.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Green', 'Affiliation': 'Department of Surgery.'}, {'ForeName': 'Hanno C', 'Initials': 'HC', 'LastName': 'Erythropel', 'Affiliation': 'Department of Chemical and Environmental Engineering.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Kong', 'Affiliation': 'Department of Psychiatry.'}, {'ForeName': 'Dana A', 'Initials': 'DA', 'LastName': 'Cavallo', 'Affiliation': 'Department of Psychiatry.'}, {'ForeName': 'Tore', 'Initials': 'T', 'LastName': 'Eid', 'Affiliation': 'Department of Laboratory Medicine.'}, {'ForeName': 'Ralitza', 'Initials': 'R', 'LastName': 'Gueorguieva', 'Affiliation': 'Department of Biostatistics.'}, {'ForeName': 'Eugenia', 'Initials': 'E', 'LastName': 'Buta', 'Affiliation': 'Department of Biostatistics.'}, {'ForeName': 'Stephanie S', 'Initials': 'SS', 'LastName': ""O'Malley"", 'Affiliation': 'Department of Psychiatry.'}, {'ForeName': 'Suchitra', 'Initials': 'S', 'LastName': 'Krishnan-Sarin', 'Affiliation': 'Department of Psychiatry.'}]",Experimental and clinical psychopharmacology,['10.1037/pha0000368']
307,32011701,Health literacy promotion among young adults: a web-based intervention in German vocational schools.,"Against the background of an ageing population, the target group of young adults holds strong societal relevance as the future workforce. At the same time, young adults find themselves in a critical phase of life regarding the manifestation of a healthy lifestyle. In this context, young adults' health literacy gains importance. Web-based interventions implemented in educational settings offer the potential for promoting health literacy, although longitudinal studies remain scarce. Within a pre-post cluster randomized controlled trial with 6-month follow-up, this study investigated whether an 8-week web-based intervention in vocational schools (with or without an additional initial face-to-face measure) improves individual competencies within a structural model of health literacy ('self-perception', 'proactive approach to health', 'dealing with health information', 'self-control', 'self-regulation' and 'communication and cooperation'). The control condition was regular school lessons following the curriculum only. A multi-level regression analysis was performed using the control group as reference. None of the interventions showed a significant improvement in any of the dimensions. Significant differences between the intervention and control were obtained for some dimensions, albeit showing reductions. Future research must examine how to build impactful health literacy promotion in educational settings. Investigations into linking digital and face-to-face measures should continue.",2020,None of the interventions showed a significant improvement in any of the dimensions.,"['young adults', 'German vocational schools']","[""8-week web-based intervention in vocational schools (with or without an additional initial face-to-face measure) improves individual competencies within a structural model of health literacy ('self-perception', 'proactive approach to health', 'dealing with health information', 'self-control', 'self-regulation' and 'communication and cooperation""]",[],"[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C1556085', 'cui_str': 'Germans (ethnic group)'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0026349', 'cui_str': 'Models, Structural'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0242498', 'cui_str': 'Self-Perception'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0684274', 'cui_str': 'Self Regulation'}, {'cui': 'C0009452', 'cui_str': 'Communication'}]",[],,0.0183436,None of the interventions showed a significant improvement in any of the dimensions.,"[{'ForeName': 'Gerrit', 'Initials': 'G', 'LastName': 'Stassen', 'Affiliation': 'Working Group Physical Activity-Related Prevention Research, Institute of Movement Therapy and Movement-Oriented Prevention and Rehabilitation, German Sport University Cologne, Am Sportpark Müngersdorf 6, Cologne 50933, Germany.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Grieben', 'Affiliation': 'Department 1: Movement-Oriented Prevention and Rehabilitation Sciences, Institute of Movement Therapy and Movement-Oriented Prevention and Rehabilitation, German Sport University Cologne, Am Sportpark Müngersdorf 6, Cologne 50933, Germany.'}, {'ForeName': 'Odile', 'Initials': 'O', 'LastName': 'Sauzet', 'Affiliation': 'Department of Epidemiology and International Public Health, Bielefeld School of Public Health, Bielefeld University, Universitätsstraße 25, Bielefeld 33501, Germany.'}, {'ForeName': 'Ingo', 'Initials': 'I', 'LastName': 'Froböse', 'Affiliation': 'Department 1: Movement-Oriented Prevention and Rehabilitation Sciences, Institute of Movement Therapy and Movement-Oriented Prevention and Rehabilitation, German Sport University Cologne, Am Sportpark Müngersdorf 6, Cologne 50933, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Schaller', 'Affiliation': 'Working Group Physical Activity-Related Prevention Research, Institute of Movement Therapy and Movement-Oriented Prevention and Rehabilitation, German Sport University Cologne, Am Sportpark Müngersdorf 6, Cologne 50933, Germany.'}]",Health education research,['10.1093/her/cyaa001']
308,31692188,Efficacy of galcanezumab in patients with episodic migraine and a history of preventive treatment failure: results from two global randomized clinical trials.,"BACKGROUND AND PURPOSE


The efficacy of galcanezumab, a monoclonal antibody for migraine prevention, has been demonstrated in two pivotal trials in patients with episodic migraine.
METHODS


EVOLVE-1 and EVOLVE-2 were identical phase 3, randomized, double-blind, placebo-controlled studies in patients with episodic migraine. Mean migraine headache days per month at baseline was 9. Patients were randomized 2:1:1 to monthly injections of placebo, galcanezumab 120 mg/240 mg during the 6-month double-blind treatment period. Key efficacy outcomes were assessed in subgroups amongst patients for whom, previously, for efficacy and/or safety/tolerability reasons (i) one or more (≥1) preventives failed, (ii) two or more (≥2) preventives failed and (iii) preventives were never used, or used but not failed (no prior failure).
RESULTS


In an integrated analysis of EVOLVE studies, galcanezumab 120 mg/240 mg versus placebo led to larger overall mean (SE) reductions in monthly migraine headache days across 6 months in patients with prior preventive failures (P < 0.001): ≥1 failure: 120 mg: -4.0 (0.4); 240 mg: -4.2 (0.5); placebo: -1.3 (0.4); ≥2 failures: 120 mg: -3.1 (0.7); 240 mg: -3.8 (0.8); placebo: -0.5 (0.6). Similar results were observed amongst patients with no prior failure, but the placebo response was larger: 120 mg: -4.7 (0.2); 240 mg: -4.5 (0.2); placebo: -3.0 (0.2) (P < 0.001 versus placebo). Significant improvements were observed with galcanezumab versus placebo for ≥50% and ≥75% reduction in monthly migraine headache days.
CONCLUSION


In patients with episodic migraine treated with galcanezumab, those with ≥1 or ≥2 prior preventive failures had significantly larger improvements, versus placebo, in efficacy outcomes. Similar results were observed in patients with no prior failure, with a larger placebo response.",2020,"Significant improvements were observed with galcanezumab versus placebo for ≥50% and ≥75% reduction in monthly migraine headache days.
","['patients with prior preventive failures (p<0.001): ≥1 failure: 120mg', 'patients with episodic migraine', 'reasons: i) one or more (≥1) preventives failed, ii) two or more (≥2) preventives failed, and iii) preventives were never used, or used but not failed (no prior failure', 'Patients with Episodic Migraine and a History of Preventive Treatment Failure']","['placebo', 'placebo, galcanezumab', 'galcanezumab versus placebo', 'galcanezumab', 'Galcanezumab']","['monthly migraine headache days', 'efficacy and/or safety/tolerability', 'Mean migraine headache']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1456501', 'cui_str': 'Preventive'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C1455761', 'cui_str': 'Episodic (qualifier value)'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0684328', 'cui_str': 'Reasoning'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",,0.261793,"Significant improvements were observed with galcanezumab versus placebo for ≥50% and ≥75% reduction in monthly migraine headache days.
","[{'ForeName': 'D D', 'Initials': 'DD', 'LastName': 'Ruff', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'J H', 'Initials': 'JH', 'LastName': 'Ford', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Tockhorn-Heidenreich', 'Affiliation': 'Eli Lilly and Company, Erl Wood Manor, Windlesham, UK.'}, {'ForeName': 'V L', 'Initials': 'VL', 'LastName': 'Stauffer', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Govindan', 'Affiliation': 'Eli Lilly Services India Private Limited, Bengaluru, India.'}, {'ForeName': 'S K', 'Initials': 'SK', 'LastName': 'Aurora', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'G M', 'Initials': 'GM', 'LastName': 'Terwindt', 'Affiliation': 'Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'P J', 'Initials': 'PJ', 'LastName': 'Goadsby', 'Affiliation': ""NIHR-Wellcome Trust King's Clinical Research Facility, SLaM Biomedical Research Centre, King's College London, London, UK.""}]",European journal of neurology,['10.1111/ene.14114']
309,32290490,Health-Related Physical Fitness Benefits in Sedentary Women Employees after an Exercise Intervention with Zumba Fitness ® .,"Background : The protective properties of high physical fitness levels on health are manifest independently of age, sex, fatness, smoking, alcohol consumption, and other clinical factors. However, women are less active than men, which contributes to low physical fitness and a high risk of CVD. Thus, the objective of this study is to analyze the effect of two exercise interventions on health-related physical fitness in sedentary employed females.  Methods : A total of 98 physically inactive adult women were randomly assigned to 3 study groups: the control group (CG) = 31, the endurance training group based on Zumba Fitness ®  classes (ET;  n  = 39), and the concurrent training group that had an extra muscle-strengthening workout after the Zumba Fitness ®  class (CnT;  n  = 28). Body composition (BMI, waist circumference), motor fitness (one-leg stand test), musculoskeletal fitness (shoulder-neck mobility, handgrip strength test, jump and reach test, and dynamic sit-up test), and cardiorespiratory fitness (2-km test and estimated VO 2  max) were assessed with the ALPHA-Fit test battery for adults.  Results : Both interventions showed a significant improvement in the majority of health-related fitness and body composition variables/test (waist circumference: ET = -2.275 ± 0.95,  p  = 0.02, CnT = -2.550 ± 1.13,  p =  0.03; one-stand leg test: ET = 13.532 ± 2.65,  p  < 0.001; CnT = 11.656 ± 2.88,  p  < 0.001; shoulder-neck mobility: ET = 1.757 ± 0.44,  p  < 0.001, CnT = 2.123 ± 0.47,  p  < 0.001; handgrip test: 0.274 ± 0.08,  p  < 0.001, CnT = 0.352 ± 0.08,  p  < 0.001; dynamic sit-up: ET = 1.769 ± 0.45,  p  < 0.001, CnT = -1.836 ± 0.49,  p  < 0.001; 2-km test time: -1.280 ± 0.25,  p  < 0.001, CnT = -1.808 ± 0.28,  p  < 0.001; estimated VO 2  max: ET = 1.306 ± 0.13,  p  < 0.001, CnT = 1.191 ± 0.15,  p  < 0.001). There were no significant differences after the intervention between the two exercise intervention groups.  Conclusions : Exercise interventions based on Zumba fitness ®  or Zumba fitness ®  combined with an extra muscle-strengthening workout based on bodyweight training exercises are effective strategies to improve the health-related physical fitness in sedentary women employees.",2020,"Both interventions showed a significant improvement in the majority of health-related fitness and body composition variables/test (waist circumference: ET = -2.275 ± 0.95,  ","['sedentary employed females', '98 physically inactive adult women', 'sedentary women employees', 'Sedentary Women Employees']","['exercise interventions', 'extra muscle-strengthening workout based on bodyweight training exercises', 'control group (CG) = 31, the endurance training group based on Zumba Fitness ®  classes (ET;  n  = 39), and the concurrent training group that had an extra muscle-strengthening workout after the Zumba Fitness ®  class (CnT']","['majority of health-related fitness and body composition variables', 'health-related physical fitness', 'ALPHA-Fit test battery for adults', 'Body composition (BMI, waist circumference), motor fitness (one-leg stand test), musculoskeletal fitness (shoulder-neck mobility, handgrip strength test, jump and reach test, and dynamic sit-up test), and cardiorespiratory fitness (2-km test and estimated VO 2  max']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0599987', 'cui_str': 'Employee'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0560837', 'cui_str': 'Does sit up'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}]",98.0,0.0334706,"Both interventions showed a significant improvement in the majority of health-related fitness and body composition variables/test (waist circumference: ET = -2.275 ± 0.95,  ","[{'ForeName': 'Yaira', 'Initials': 'Y', 'LastName': 'Barranco-Ruiz', 'Affiliation': 'Department of Physical and Sports Education, PROFITH ""PROmoting FITness and Health through Physical Activity"" Research Group, Sport and Health University Research Institute (iMUDS), Faculty of Education and Sport Sciences, University of Granada, Melilla 52071, Spain.'}, {'ForeName': 'Emilio', 'Initials': 'E', 'LastName': 'Villa-González', 'Affiliation': 'Department of Physical and Sports Education, PROFITH ""PROmoting FITness and Health through Physical Activity"" Research Group, Sport and Health University Research Institute (iMUDS), Faculty of Education and Sport Sciences, University of Granada, Melilla 52071, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17082632']
310,31772079,Efficacy of sofosbuvir as treatment for yellow fever: protocol for a randomised controlled trial in Brazil (SOFFA study).,"INTRODUCTION


An ongoing outbreak of yellow fever (YF) has been reported in Brazil with 1261 confirmed cases and 409 deaths since July 2017. To date, there is no specific treatment available for YF. Recently published papers describing in vitro and animal models suggest a potential effect of antiviral drugs (approved for the treatment of hepatitis virus) against flaviviruses, including YF. The primary aim of this study is to analyse the effect of sofosbuvir on viral kinetics and clinical outcomes among patients presenting with YF. This is a multicentre open-label randomised controlled trial with 1:1 individual allocation, stratified by severity and by recruiting centre.
METHODS AND ANALYSIS


Adults with suspected or confirmed YF infection and symptoms lasting up to 15 days are screened. Eligible and consenting patients are randomised to receive oral sofosbuvir 400 mg daily for 10 days or to receive standard clinical care. Viral kinetics are measured daily and the reduction in YF plasma viral load from the sample at inclusion to 72 hours after randomisation will be compared between active and control groups. Clinical outcomes include severity meeting criteria for intensive care support, liver transplantation, in-hospital mortality and mortality within 60 days.
ETHICS AND DISSEMINATION


Ethics approval was obtained at the participating sites and at the national research ethics committee (CAAE 82673018.6.1001.0068). The trial has been submitted for ethical approval at additional potential recruiting centres. Results of the study will be published in journals and presented at scientific meetings.
TRIAL REGISTRATION


Brazilian Clinical Trials Registry (RBR-93dp9n).",2019,An ongoing outbreak of yellow fever (YF) has been reported in Brazil with 1261 confirmed cases and 409 deaths since July 2017.,"['patients presenting with YF', 'Brazil with 1261 confirmed cases and 409 deaths since July 2017', 'Adults with suspected or confirmed YF infection and symptoms lasting up to 15 days are screened', 'Eligible and consenting patients']","['sofosbuvir', 'oral sofosbuvir 400\u2009mg daily for 10 days or to receive standard clinical care']","['severity meeting criteria for intensive care support, liver transplantation, in-hospital mortality and mortality within 60 days', 'YF plasma viral load', 'viral kinetics and clinical outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}]","[{'cui': 'C2976303', 'cui_str': 'sofosbuvir'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C3696663', 'cui_str': 'sofosbuvir 400 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]","[{'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0556656', 'cui_str': 'Meetings (procedure)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0085559'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0023911', 'cui_str': 'Transplantation, Hepatic'}, {'cui': 'C0085556', 'cui_str': 'Mortalities, In-house'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]",,0.304283,An ongoing outbreak of yellow fever (YF) has been reported in Brazil with 1261 confirmed cases and 409 deaths since July 2017.,"[{'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Figueiredo-Mello', 'Affiliation': 'Department of Education and Research, Instituto de Infectologia Emilio Ribas, Sao Paulo, SP, Brazil claudiamello@ymail.com.'}, {'ForeName': 'Luciana Vilas Boas', 'Initials': 'LVB', 'LastName': 'Casadio', 'Affiliation': 'Department of Infectious and Parasitic Diseases, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil.'}, {'ForeName': 'Vivian Iida', 'Initials': 'VI', 'LastName': 'Avelino-Silva', 'Affiliation': 'Department of Infectious and Parasitic Diseases, Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, SP, Brazil.'}, {'ForeName': 'Ho', 'Initials': 'H', 'LastName': 'Yeh-Li', 'Affiliation': 'Department of Infectious and Parasitic Diseases, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil.'}, {'ForeName': 'Jaques', 'Initials': 'J', 'LastName': 'Sztajnbok', 'Affiliation': 'Medical Division-Intensive Care Unit, Instituto de Infectologia Emilio Ribas, Sao Paulo, SP, Brazil.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Joelsons', 'Affiliation': 'Department of Infectious and Parasitic Diseases, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil.'}, {'ForeName': 'Marilia Bordignon', 'Initials': 'MB', 'LastName': 'Antonio', 'Affiliation': 'Department of Infectious and Parasitic Diseases, Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, SP, Brazil.'}, {'ForeName': 'João Renato Rebello', 'Initials': 'JRR', 'LastName': 'Pinho', 'Affiliation': 'Department of Gastroenterology (LIM07), Faculdade de Medicina FMUSP, Universidade de São Paulo, Sao Paulo, SP, Brazil.'}, {'ForeName': 'Fernanda de Mello', 'Initials': 'FM', 'LastName': 'Malta', 'Affiliation': 'Department of Gastroenterology (LIM07), Faculdade de Medicina FMUSP, Universidade de São Paulo, Sao Paulo, SP, Brazil.'}, {'ForeName': 'Michele Soares', 'Initials': 'MS', 'LastName': 'Gomes-Gouvêa', 'Affiliation': 'Department of Gastroenterology (LIM07), Faculdade de Medicina FMUSP, Universidade de São Paulo, Sao Paulo, SP, Brazil.'}, {'ForeName': 'Ana Paula Moreira', 'Initials': 'APM', 'LastName': 'Salles', 'Affiliation': 'Department of Gastroenterology (LIM07), Faculdade de Medicina FMUSP, Universidade de São Paulo, Sao Paulo, SP, Brazil.'}, {'ForeName': 'Aline Pivetta', 'Initials': 'AP', 'LastName': 'Corá', 'Affiliation': 'Clinical Lab, Instituto de Infectologia Emilio Ribas, Sao Paulo, SP, Brazil.'}, {'ForeName': 'Carlos Henrique Valente', 'Initials': 'CHV', 'LastName': 'Moreira', 'Affiliation': 'Inpatient Unit, Instituto de Infectologia Emilio Ribas, Sao Paulo, SP, Brazil.'}, {'ForeName': 'Ana Freitas', 'Initials': 'AF', 'LastName': 'Ribeiro', 'Affiliation': 'Epidemiology Service, Instituto de Infectologia Emilio Ribas, Sao Paulo, SP, Brazil.'}, {'ForeName': 'Ana Catharina de Seixas Santos', 'Initials': 'ACSS', 'LastName': 'Nastri', 'Affiliation': 'Department of Infectious and Parasitic Diseases, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil.'}, {'ForeName': ""Ceila Maria Sant'Ana"", 'Initials': 'CMS', 'LastName': 'Malaque', 'Affiliation': 'Medical Division-Intensive Care Unit, Instituto de Infectologia Emilio Ribas, Sao Paulo, SP, Brazil.'}, {'ForeName': 'Ralcyon Francis Azevedo', 'Initials': 'RFA', 'LastName': 'Teixeira', 'Affiliation': 'Medical Division, Instituto de Infectologia Emilio Ribas, Sao Paulo, SP, Brazil.'}, {'ForeName': 'Luciana Marques Sansão', 'Initials': 'LMS', 'LastName': 'Borges', 'Affiliation': 'Medical Emergency Department, Instituto de Infectologia Emilio Ribas, Sao Paulo, SP, Brazil.'}, {'ForeName': 'Mario Peribañez', 'Initials': 'MP', 'LastName': 'Gonzalez', 'Affiliation': 'Outpatients Clinic, Instituto de Infectologia Emilio Ribas, Sao Paulo, SP, Brazil.'}, {'ForeName': 'Luiz Carlos Pereira', 'Initials': 'LCP', 'LastName': 'Junior', 'Affiliation': 'Technical Department, Instituto de Infectologia Emilio Ribas, Sao Paulo, SP, Brazil.'}, {'ForeName': 'Tâmara Newman Lobato', 'Initials': 'TNL', 'LastName': 'Souza', 'Affiliation': 'ER and Outpatient Service, Instituto de Infectologia Emilio Ribas, Sao Paulo, SP, Brazil.'}, {'ForeName': 'Alice Tung Wan', 'Initials': 'ATW', 'LastName': 'Song', 'Affiliation': 'Department of Gastroenterology, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil.'}, {'ForeName': 'Luiz Augusto Carneiro', 'Initials': 'LAC', 'LastName': ""D'Albuquerque"", 'Affiliation': 'Department of Gastroenterology, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil.'}, {'ForeName': 'Edson', 'Initials': 'E', 'LastName': 'Abdala', 'Affiliation': 'Department of Infectious and Parasitic Diseases, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil.'}, {'ForeName': 'Wellington', 'Initials': 'W', 'LastName': 'Andraus', 'Affiliation': 'Department of Gastroenterology, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil.'}, {'ForeName': 'Rodrigo Bronze de', 'Initials': 'RB', 'LastName': 'Martino', 'Affiliation': 'Department of Gastroenterology, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil.'}, {'ForeName': 'Liliana', 'Initials': 'L', 'LastName': 'Ducatti', 'Affiliation': 'Department of Gastroenterology, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil.'}, {'ForeName': 'Guilherme Marques', 'Initials': 'GM', 'LastName': 'Andrade', 'Affiliation': 'Department of Gastroenterology, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil.'}, {'ForeName': 'Luiz Marcelo Sá', 'Initials': 'LMS', 'LastName': 'Malbouisson', 'Affiliation': 'Department of Gastroenterology, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil.'}, {'ForeName': 'Izabel Marcilio de', 'Initials': 'IM', 'LastName': 'Souza', 'Affiliation': 'Epidemiologic Surveillance Department, Universidade de São Paulo Hospital das Clínicas, Sao Paulo, SP, Brazil.'}, {'ForeName': 'Flair José', 'Initials': 'FJ', 'LastName': 'Carrilho', 'Affiliation': 'Department of Gastroenterology, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil.'}, {'ForeName': 'Ester Cerdeira', 'Initials': 'EC', 'LastName': 'Sabino', 'Affiliation': 'Department of Infectious and Parasitic Diseases, Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, SP, Brazil.'}, {'ForeName': 'Anna S', 'Initials': 'AS', 'LastName': 'Levin', 'Affiliation': 'Department of Infectious and Parasitic Diseases, Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, SP, Brazil.'}]",BMJ open,['10.1136/bmjopen-2018-027207']
311,31791962,Paramedic attitudes and experiences of enrolling patients into the PARAMEDIC-2 adrenaline trial: a qualitative survey within the London Ambulance Service.,"OBJECTIVES


The aim of this study was to gather the views and experiences of paramedics who participated in a large-scale randomised controlled drug trial and to identify barriers to recruitment.
DESIGN


We surveyed paramedics using a questionnaire consisting of a mix of closed and open ended questions.
SETTING


The study was conducted within the London Ambulance Service, London, UK.
PARTICIPANTS


150 paramedics who were trained to enrol patients into the PARAMEDIC-2 randomised controlled trial of adrenaline versus placebo in out-of-hospital cardiac arrest and who returned the questionnaire.
RESULTS


98% of study participants felt prehospital research was very important, and 97.3% reported an overall positive experience of being involved in a drug trial. Only 5.3% felt uncomfortable enrolling patients into the trial without prior consent from the patient or a relative. Over one- third (39.3%) identified one or more barriers to patient recruitment, the most common being the attitudes of other staff.
CONCLUSION


We found a strong appetite for involvement in prehospital research among paramedics and an understanding of the importance of research that prevailed over the complexities of the trial. This is an important finding demonstrating that potentially ethically controversial research can be undertaken successfully by paramedics in the prehospital environment.",2019,This is an important finding demonstrating that potentially ethically controversial research can be undertaken successfully by paramedics in the prehospital environment.,"['The study was conducted within the London Ambulance Service, London, UK', 'in out-of-hospital cardiac arrest and who returned the questionnaire', '150 paramedics who were trained to enrol patients']",['adrenaline versus placebo'],[],"[{'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C0002422', 'cui_str': 'Ambulances'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C2936490', 'cui_str': 'Out-of-Hospital Heart Arrest'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0030450', 'cui_str': 'Paramedics'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.0754389,This is an important finding demonstrating that potentially ethically controversial research can be undertaken successfully by paramedics in the prehospital environment.,"[{'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Lazarus', 'Affiliation': 'London Ambulance Service NHS Trust, London, UK.'}, {'ForeName': 'Rajeshwari', 'Initials': 'R', 'LastName': 'Iyer', 'Affiliation': 'London Ambulance Service NHS Trust, London, UK.'}, {'ForeName': 'Rachael T', 'Initials': 'RT', 'LastName': 'Fothergill', 'Affiliation': 'London Ambulance Service NHS Trust, London, UK rachael.fothergill@lond-amb.nhs.uk.'}]",BMJ open,['10.1136/bmjopen-2018-025588']
312,31282129,Renal insufficiency following contrast media administration trial III: Urine flow rate-guided versus left-ventricular end-diastolic pressure-guided hydration in high-risk patients for contrast-induced acute kidney injury. Rationale and design.,"BACKGROUND


Urine flow rate (UFR)-guided and left-ventricular end-diastolic pressure (LVEDP)-guided hydration regimens have been proposed to prevent contrast-induced acute kidney injury (CIAKI). The REnal Insufficiency Following Contrast MEDIA Administration triaL III (REMEDIAL III) is a randomized, multicenter, investigator-sponsored trial aiming to compare these two hydration strategies.
METHODS


Patients at high risk for CIAKI (that is, those with estimated glomerular filtration rate ≤ 45 mL/min/1.73 m 2  and/or with Mehran's score ≥11 and/or Gurm's score >7) will be enrolled. Patients will be randomly assigned to (a) LVEDP-guided hydration with normal saline (LVEDP-guided group) and (b) UFR-guided hydration carried out by the RenalGuard system (RenalGuard group). Seven-hundred patients (350 in each arm) will be enrolled. In the LVEDP-guided group the fluid infusion rate will be adjusted according to the LVEDP as follows: 5 mL kg -1  hr -1  for LVEDP ≤12 mmHg, 3 mL kg -1  hr -1  for LVEDP 13-18 mmHg, and 1.5 mL kg -1  hr -1  for LVEDP >18 mmHg. In the RenalGuard group hydration with normal saline plus low-dose of furosemide is controlled by the RenalGuard system, in order to reach and maintain a high (>300 mL/hr) UFR. In all cases, iobitridol (a low-osmolar, nonionic contrast agent) will be administered.
RESULTS


The primary endpoint is the composite of CIAKI (i.e., serum creatinine increase ≥25% and/or ≥0.5 mg/dL from the baseline to 48 hr after contrast media exposure) and/or acute pulmonary edema.
CONCLUSION


The REMEDIAL III will test the hypothesis that the UFR-guided hydration is superior to the LVEDP-guided hydration to prevent the composite of CIAKI and/or acute pulmonary edema.",2020,-1  hr -1  for LVEDP,"['Seven-hundred patients (350 in each arm) will be enrolled', 'high-risk patients for contrast-induced acute kidney injury', ""Patients at high risk for CIAKI (that is, those with estimated glomerular filtration rate\u2009≤\u200945\u2009mL/min/1.73\u2009m 2  and/or with Mehran's score""]","['Urine flow rate-guided versus left-ventricular end-diastolic pressure-guided hydration', 'normal saline plus low-dose of furosemide', 'LVEDP-guided hydration with normal saline (LVEDP-guided group) and (b) UFR-guided hydration carried out by the RenalGuard system (RenalGuard group', 'iobitridol', 'LVEDP']","['composite of CIAKI (i.e., serum creatinine increase ≥25', 'fluid infusion rate']","[{'cui': 'C4517862', 'cui_str': '700 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C2609414', 'cui_str': 'Acute Renal Injury'}, {'cui': 'C3811844'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]","[{'cui': 'C0042037'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C1171395', 'cui_str': 'Left ventricular end-diastolic pressure'}, {'cui': 'C1321013', 'cui_str': 'Hydration'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0016860', 'cui_str': 'Furosemide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0296806', 'cui_str': 'iobitridol'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0700225', 'cui_str': 'Serum creatinine raised (finding)'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}]",700.0,0.0915012,-1  hr -1  for LVEDP,"[{'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Briguori', 'Affiliation': 'Interventional Cardiology Unit, Mediterranea Cardiocentro, Naples, Italy.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': ""D'Amore"", 'Affiliation': 'Interventional Cardiology Unit, Mediterranea Cardiocentro, Naples, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'De Micco', 'Affiliation': 'Interventional Cardiology Unit, Mediterranea Cardiocentro, Naples, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Signore', 'Affiliation': 'Interventional Cardiology Unit, Policlinico di Bari, Bari, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Esposito', 'Affiliation': 'Department of Advanced Biomedical Science, Division of Cardiology, ""Federico II"" University of Naples, Naples, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Napolitano', 'Affiliation': 'Department of Cardiology, Ospedale San Giuliano, Giuliano, Italy.'}, {'ForeName': 'Amelia', 'Initials': 'A', 'LastName': 'Focaccio', 'Affiliation': 'Interventional Cardiology Unit, Mediterranea Cardiocentro, Naples, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.28386']
313,32178430,"Agility Training to Integratively Promote Neuromuscular, Cognitive, Cardiovascular and Psychosocial Function in Healthy Older Adults: A Study Protocol of a One-Year Randomized-Controlled Trial.","Exercise training effectively mitigates aging-induced health and fitness impairments. Traditional training recommendations for the elderly focus separately on relevant physiological fitness domains, such as balance, flexibility, strength and endurance. Thus, a more holistic and functional training framework is needed. The proposed agility training concept integratively tackles spatial orientation, stop and go, balance and strength. The presented protocol aims at introducing a two-armed, one-year randomized controlled trial, evaluating the effects of this concept on neuromuscular, cardiovascular, cognitive and psychosocial health outcomes in healthy older adults. Eighty-five participants were enrolled in this ongoing trial. Seventy-nine participants completed baseline testing and were block-randomized to the agility training group or the inactive control group. All participants undergo pre- and post-testing with interim assessment after six months. The intervention group currently receives supervised, group-based agility training twice a week over one year, with progressively demanding perceptual, cognitive and physical exercises. Knee extension strength, reactive balance, dual task gait speed and the Agility Challenge for the Elderly (ACE) serve as primary endpoints and neuromuscular, cognitive, cardiovascular, and psychosocial meassures serve as surrogate secondary outcomes. Our protocol promotes a comprehensive exercise training concept for older adults, that might facilitate stakeholders in health and exercise to stimulate relevant health outcomes without relying on excessively time-consuming physical activity recommendations.",2020,Seventy-nine participants completed baseline testing and were block-randomized to the agility training group or the inactive control group.,"['Eighty-five participants were enrolled in this ongoing trial', 'older adults', 'Healthy Older Adults', 'Seventy-nine participants completed baseline testing and were block-randomized to the', 'healthy older adults']","['intervention group currently receives supervised, group-based agility training twice a week over one year, with progressively demanding perceptual, cognitive and physical exercises', 'comprehensive exercise training concept', 'Exercise training', 'agility training group or the inactive control group', 'Agility Training to Integratively']","['Promote Neuromuscular, Cognitive, Cardiovascular and Psychosocial Function', 'Knee extension strength, reactive balance, dual task gait speed and the Agility Challenge', 'health and fitness impairments', 'neuromuscular, cardiovascular, cognitive and psychosocial health outcomes']","[{'cui': 'C4517892', 'cui_str': '85'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0556985', 'cui_str': 'Two times a week'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0205332', 'cui_str': 'Reactive (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}]",85.0,0.0275368,Seventy-nine participants completed baseline testing and were block-randomized to the agility training group or the inactive control group.,"[{'ForeName': 'Mareike', 'Initials': 'M', 'LastName': 'Morat', 'Affiliation': 'Department of Intervention Research in Exercise Training, Institute of Exercise Training and Sport Informatics, German Sport University Cologne, Am Sportpark Muengersdorf 6, 50933 Cologne, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Faude', 'Affiliation': 'Department of Sport, Exercise and Health, University of Basel, Birsstrasse 320 B, 4052 Basel, Switzerland.'}, {'ForeName': 'Henner', 'Initials': 'H', 'LastName': 'Hanssen', 'Affiliation': 'Department of Sport, Exercise and Health, University of Basel, Birsstrasse 320 B, 4052 Basel, Switzerland.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Ludyga', 'Affiliation': 'Department of Sport, Exercise and Health, University of Basel, Birsstrasse 320 B, 4052 Basel, Switzerland.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Zacher', 'Affiliation': 'Institute of Cardiology and Sports Medicine, German Sport University Cologne, Am Sportpark Muengersdorf 6, 50933 Cologne, Germany.'}, {'ForeName': 'Angi', 'Initials': 'A', 'LastName': 'Eibl', 'Affiliation': 'Institute of Cardiology and Sports Medicine, German Sport University Cologne, Am Sportpark Muengersdorf 6, 50933 Cologne, Germany.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Albracht', 'Affiliation': 'Institute of Biomechanics and Orthopaedics, German Sport University Cologne, Am Sportpark Muengersdorf 6, 50933 Cologne, Germany.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Donath', 'Affiliation': 'Department of Intervention Research in Exercise Training, Institute of Exercise Training and Sport Informatics, German Sport University Cologne, Am Sportpark Muengersdorf 6, 50933 Cologne, Germany.'}]",International journal of environmental research and public health,['10.3390/ijerph17061853']
314,31772078,Rationale and design of the theRapeutic effects of peroneal nerve functionAl electrical stimuLation for Lower extremitY in patients with convalescent poststroke hemiplegia (RALLY) study: study protocol for a randomised controlled study.,"INTRODUCTION


Increasing evidence supports the utilisation of functional electrical stimulation (FES) to improve gait following stroke; however, few studies have focused exclusively on its use in the convalescent phase. In addition, its efficacy in patients with a non-Western life style has not been evaluated.
METHODS AND ANALYSIS


This is a randomised, controlled, open-label multicentre study, comparing rehabilitation with and without FES. The purpose of our study is to test the hypothesis that the FES system improves walking ability in Japanese patients with hemiplegia during the convalescent phase. Two hundred patients aged 20-85 years who had an initial stroke ≤6 months prior to the enrolment, are in a convalescent phase (after the end of acute phase treatment, within 6 months after the onset of stroke) with functional ambulation classification 3 or 4 and have a hemiplegic gait disorder (drop foot) due to stroke have been recruited from 21 institutions in Japan. The patients are randomised in 1:1 fashion to usual gait rehabilitation or rehabilitation using FES (Walkaide). The trial duration is 8 weeks, and the primary outcome measured will be the change in maximum distance from baseline to the end of the trial, as measured with the 6 min walk test (6-MWT). The 6-MWT is performed barefoot, and the two treatment groups are compared using the analysis of covariance.
ETHICS AND DISSEMINATION


This study is conducted in accordance with the principles of the Declaration of Helsinki and the Ethical Guidelines for Medical and Health Research Involving Human Subjects and is approved by the ethics committee of all participating institutions. The published results will be disseminated to all the participants by the study physicians.
TRIAL REGISTRATION NUMBER


The University Hospital Medical Information Network-Clinical Studies Registry (UMIN000020604).",2019,"Two hundred patients aged 20-85 years who had an initial stroke ≤6 months prior to the enrolment, are in a convalescent phase (after the end of acute phase treatment, within 6 months after the onset of stroke) with functional ambulation classification 3 or 4 and have a hemiplegic gait disorder (drop foot) due to stroke have been recruited from 21 institutions in Japan.","['patients with convalescent poststroke hemiplegia (RALLY) study', 'patients with a non-Western life style', 'Two hundred patients aged 20-85 years who had an initial stroke ≤6 months prior to the enrolment, are in a convalescent phase (after the end of acute phase treatment, within 6 months after the onset of stroke) with functional ambulation classification 3 or 4 and have a hemiplegic gait disorder (drop foot) due to stroke have been recruited from 21 institutions in Japan', 'Japanese patients with hemiplegia during the convalescent phase']","['usual gait rehabilitation or rehabilitation using FES (Walkaide', 'functional electrical stimulation (FES', 'peroneal nerve functionAl electrical stimuLation', 'FES system', '6-MWT']","['6\u2009min walk test (6-MWT', 'walking ability']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0740326', 'cui_str': 'Convalescent'}, {'cui': 'C0018991', 'cui_str': 'Hemiplegia'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0439558', 'cui_str': 'Convalescent phase (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0439557', 'cui_str': 'Acute phase (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0945826', 'cui_str': 'Ambulation'}, {'cui': 'C0008903', 'cui_str': 'taxonomy'}, {'cui': 'C0231696', 'cui_str': 'Gait, Hemiplegic'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C1272753', 'cui_str': 'Institution'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}]","[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0674267', 'cui_str': 'greigite'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0013786', 'cui_str': 'Electrical Stimulation'}, {'cui': 'C4316912', 'cui_str': 'Fibular Nerve'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0559964', 'cui_str': 'Ambulation ability'}]",200.0,0.108934,"Two hundred patients aged 20-85 years who had an initial stroke ≤6 months prior to the enrolment, are in a convalescent phase (after the end of acute phase treatment, within 6 months after the onset of stroke) with functional ambulation classification 3 or 4 and have a hemiplegic gait disorder (drop foot) due to stroke have been recruited from 21 institutions in Japan.","[{'ForeName': 'Shuji', 'Initials': 'S', 'LastName': 'Matsumoto', 'Affiliation': 'Department of Rehabilitation and Physical Medicine, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan shujimatsumotorehab@gmail.com.'}, {'ForeName': 'Megumi', 'Initials': 'M', 'LastName': 'Shimodozono', 'Affiliation': 'Department of Rehabilitation and Physical Medicine, Graduate School of Medical and Dental Sciences, Kagoshima University, Kagoshima, Japan.'}, {'ForeName': 'Tomokazu', 'Initials': 'T', 'LastName': 'Noma', 'Affiliation': 'Department of Rehabilitation, Kirishima Rehabilitation Center of Kagoshima University Hospital, Kagoshima, Japan.'}]",BMJ open,['10.1136/bmjopen-2018-026214']
315,31168928,Measurement Equivalence of E-Scale and In-Person Clinic Weights.,"OBJECTIVE


The current study aimed to determine whether electronic scale (e-scale) weight measurements are concordant with in-person clinic weights.
METHODS


E-scale and in-person clinic weight measurements from 248 active duty military personnel enrolled in a weight-loss intervention study were used. E-scale and clinic measurements were matched and tested to determine whether measurements were significantly different from each other. Equivalence between the two measurements was tested among the cohort and when stratifying by gender, BMI, race, and age. The study also examined whether matching the times of clinic and e-scale measurements or averaging multiple measurements was optimal, and whether using e-scale and clinic measurements from the same day or across a specified amount of time was acceptable.
RESULTS


Overall, e-scale and clinic measurements were significantly different from each other but did not differ from equality. Additionally, using e-scale and clinic weight measurements that were taken on the same day may be a preferable method compared with using measurements within a week of each other, which leads to weight underprediction among e-scale measurements.
CONCLUSIONS


E-scales display good measurement concordance. E-scales may be helpful when studying highly mobile populations, such as military personnel, and could potentially eliminate the need for in-person visits.",2019,"Overall, e-scale and clinic measurements were significantly different from each other but did not differ from equality.",['E-scale and in-person clinic weight measurements from 248 active duty military personnel enrolled in a weight-loss intervention study were used'],[],"['electronic scale (e-scale) weight measurements', 'Overall, e-scale and clinic measurements', 'E-scale and clinic measurements']","[{'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0043101', 'cui_str': 'Weights and Measures'}, {'cui': 'C3831794', 'cui_str': 'Active duty military'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C1096775', 'cui_str': 'Intervention Study'}]",[],"[{'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0043101', 'cui_str': 'Weights and Measures'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",248.0,0.0338878,"Overall, e-scale and clinic measurements were significantly different from each other but did not differ from equality.","[{'ForeName': 'Kinsey', 'Initials': 'K', 'LastName': 'Pebley', 'Affiliation': 'Department of Psychology, University of Memphis, Memphis, Tennessee, USA.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Klesges', 'Affiliation': 'Department of Public Health Sciences, University of Virginia School of Medicine, Charlottesville, Virginia, USA.'}, {'ForeName': 'G Wayne', 'Initials': 'GW', 'LastName': 'Talcott', 'Affiliation': 'Department of Public Health Sciences, University of Virginia School of Medicine, Charlottesville, Virginia, USA.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Kocak', 'Affiliation': 'Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, Tennessee, USA.'}, {'ForeName': 'Rebecca A', 'Initials': 'RA', 'LastName': 'Krukowski', 'Affiliation': 'Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, Tennessee, USA.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22512']
316,32191600,Countering disuse atrophy in older adults with low-volume leucine supplementation.,"Older adults are at increased risk of being bedridden and experiencing negative health outcomes including the loss of muscle tissue and functional capacity. We hypothesized that supplementing daily meals with a small quantity (3-4 g/meal) of leucine would partially preserve lean leg mass and function of older adults during bed rest. During a 7-day bed rest protocol, followed by 5 days of inpatient rehabilitation, healthy older men and women (67.8 ± 1.1 yr, 14 men; 6 women) were randomized to receive isoenergetic meals supplemented with leucine (LEU, 0.06 g/kg/meal;  n  = 10) or an alanine control (CON, 0.06 g/kg/meal;  n  = 10). Outcomes were assessed at baseline, following bed rest, and after rehabilitation. Body composition was measured by dual-energy X-ray absorptiometry. Functional capacity was assessed by knee extensor isokinetic and isometric dynamometry, peak aerobic capacity, and the short physical performance battery. Muscle fiber type, cross-sectional area, signaling protein expression levels, and single fiber characteristics were determined from biopsies of the vastus lateralis. Leucine supplementation reduced the loss of leg lean mass during bed rest (LEU vs. CON: -423 vs. -1035 ± 143 g;  P  = 0.008) but had limited impact on strength or endurance-based functional outcomes. Similarly, leucine had no effect on markers of anabolic signaling and protein degradation during bed rest or rehabilitation. In conclusion, providing older adults with supplemental leucine has minimal impact on total energy or protein consumption and has the potential to partially counter some, but not all, of the negative effects of inactivity on muscle health. NEW & NOTEWORTHY  Skeletal muscle morphology and function in older adults was significantly compromised by 7 days of disuse. Leucine supplementation partially countered the loss of lean leg mass but did not preserve muscle function or positively impact changes at the muscle fiber level associated with bed rest or rehabilitation. Of note, our data support a relationship between myonuclear content and adaptations to muscle atrophy at the whole limb and single fiber level.",2020,Leucine supplementation reduced the loss of leg lean mass during bed rest (LEU vs. CON: -423 vs. -1035 ± 143 g; p=0.008) but had limited impact on strength or endurance based functional outcomes.,"['older adults with', 'Older adults', 'older adults during bed rest', 'healthy older men and women (67.8 ± 1.1 y, 14 men; 6 women', 'older adults with low volume leucine supplementation']","['isoenergentic meals supplemented with leucine (LEU, 0.06 g/kg/meal; n=10) or an alanine control', 'supplemental leucine', 'Leucine supplementation', 'leucine']","['knee extensor isokinetic and isometric dynamometry, peak aerobic capacity and the short physical performance battery', 'Body composition', 'Muscle fiber type, cross-sectional area, signaling protein expression levels and single fiber characteristics', 'loss of leg lean mass', 'strength or endurance based functional outcomes', 'Functional capacity', 'markers of anabolic signaling and protein degradation']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004910', 'cui_str': 'Bedrest'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4517491', 'cui_str': 'One point one'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0023401', 'cui_str': 'L-leucine'}]","[{'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0023401', 'cui_str': 'L-leucine'}, {'cui': 'C4517412', 'cui_str': 'Zero point zero six'}, {'cui': 'C1300563', 'cui_str': 'ug/mg'}, {'cui': 'C0001898', 'cui_str': 'L-alanine'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0205155', 'cui_str': 'Sectional (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0597304', 'cui_str': 'Protein Degradation'}]",,0.049476,Leucine supplementation reduced the loss of leg lean mass during bed rest (LEU vs. CON: -423 vs. -1035 ± 143 g; p=0.008) but had limited impact on strength or endurance based functional outcomes.,"[{'ForeName': 'Emily J', 'Initials': 'EJ', 'LastName': 'Arentson-Lantz', 'Affiliation': 'Department of Nutrition and Metabolism, University of Texas Medical Branch, Galveston, Texas.'}, {'ForeName': 'Kinga N', 'Initials': 'KN', 'LastName': 'Fiebig', 'Affiliation': 'Institute for Physical Activity and Nutrition (IPAN), Faculty of Health, Deakin University, Melbourne, Australia.'}, {'ForeName': 'Kim J', 'Initials': 'KJ', 'LastName': 'Anderson-Catania', 'Affiliation': 'Institute for Physical Activity and Nutrition (IPAN), Faculty of Health, Deakin University, Melbourne, Australia.'}, {'ForeName': 'Rachel R', 'Initials': 'RR', 'LastName': 'Deer', 'Affiliation': 'Center for Recovery, Physical Activity and Nutrition, University of Texas Medical Branch, Galveston, Texas.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Wacher', 'Affiliation': 'Department of Anesthesiology, University of Texas Medical Branch, Galveston, Texas.'}, {'ForeName': 'Christopher S', 'Initials': 'CS', 'LastName': 'Fry', 'Affiliation': 'Department of Nutrition and Metabolism, University of Texas Medical Branch, Galveston, Texas.'}, {'ForeName': 'Séverine', 'Initials': 'S', 'LastName': 'Lamon', 'Affiliation': 'Institute for Physical Activity and Nutrition (IPAN), Faculty of Health, Deakin University, Melbourne, Australia.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Paddon-Jones', 'Affiliation': 'Department of Nutrition and Metabolism, University of Texas Medical Branch, Galveston, Texas.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00847.2019']
317,32065672,Bioavailability and safety of diazepam intranasal solution compared to oral and rectal diazepam in healthy volunteers.,"OBJECTIVE


The study assesses the bioavailability of diazepam after intranasal administration (diazepam nasal spray) in healthy volunteers. Comparative agents were diazepam rectal gel, which served as the regulatory reference product; and oral diazepam, a product with decades of clinical use. Tolerability of diazepam nasal spray was also assessed.
METHODS


This was a phase 1, open-label, randomized, single-dose, three-treatment, three-period, six-sequence crossover study in 48 healthy adult subjects that consisted of a screening period, a baseline period, and an open-label treatment period. Interperiod intervals were at least 28 days.
RESULTS


Forty-eight healthy volunteer subjects were enrolled, two of whom discontinued before receiving study medication. For all routes of administration, the onset of diazepam absorption was rapid, with measurable concentrations of drug present by the first sample time point. The t max  (time to reach maximum plasma concentration) was similar for diazepam nasal spray and diazepam rectal gel, both of which were slower than oral diazepam in fasted individuals. Variability (as defined by % coefficient of variation of geometric mean) in peak plasma concentration and area under the curve 0-∞  was lowest with oral diazepam, followed by diazepam nasal spray, with diazepam rectal gel showing the greatest variability. Overall, 131 treatment-emergent adverse events (TEAEs) were considered mild (42 subjects, 91.3%), four TEAEs were considered moderate (four subjects, 8.3%), and no TEAEs were considered severe. The most commonly reported TEAE was somnolence at 56.5% (26/46) during diazepam nasal spray treatment, 89.1% (41/46) with the rectal diazepam gel treatment, and 82.6% (38/46) with oral diazepam treatment. No nasal irritation was observed for the majority of the subjects at any time point after administration, with no score higher than 2 (""minor bleeding that stops within 1 minute"").
SIGNIFICANCE


Diazepam nasal spray shows predicable pharmacokinetics and represents a potential novel therapeutic approach to control bouts of increased seizure activity (cluster seizures, acute repetitive seizures).",2020,"The t max  (time to reach maximum plasma concentration) was similar for diazepam nasal spray and diazepam rectal gel, both of which were slower than oral diazepam in fasted individuals.","['healthy volunteers', '48 healthy adult subjects', 'Forty-eight healthy volunteer subjects']","['intranasal administration (diazepam nasal spray', 'diazepam rectal gel', 'oral and rectal diazepam', 'diazepam nasal spray, with diazepam rectal gel', 'diazepam nasal spray', 'diazepam intranasal solution', 'diazepam']","['somnolence', 'Bioavailability and safety', 'Tolerability', 'bioavailability', 'peak plasma concentration and area under the curve', 't max  (time to reach maximum plasma concentration', 'nasal irritation', 'Variability']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C4319608', 'cui_str': 'Forty-eight'}]","[{'cui': 'C0001560', 'cui_str': 'Drug Administration, Intranasal'}, {'cui': 'C0012010', 'cui_str': 'Diazepam'}, {'cui': 'C0461725', 'cui_str': 'Nasal Spray'}, {'cui': 'C2340854', 'cui_str': 'Diazepam Rectal Gel [Diastat]'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0205052', 'cui_str': 'Rectal (qualifier value)'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}]","[{'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0005508', 'cui_str': 'Bioavailability'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0240557', 'cui_str': 'Irritation of nose'}]",48.0,0.0266964,"The t max  (time to reach maximum plasma concentration) was similar for diazepam nasal spray and diazepam rectal gel, both of which were slower than oral diazepam in fasted individuals.","[{'ForeName': 'R Edward', 'Initials': 'RE', 'LastName': 'Hogan', 'Affiliation': 'Department of Neurology, Washington University in St Louis School of Medicine, St Louis, Missouri.'}, {'ForeName': 'Barry E', 'Initials': 'BE', 'LastName': 'Gidal', 'Affiliation': 'School of Pharmacy, University of Wisconsin, Madison, Wisconsin.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Koplowitz', 'Affiliation': 'DUCK FLATS Pharma, Elbridge, New York.'}, {'ForeName': 'Luana P', 'Initials': 'LP', 'LastName': 'Koplowitz', 'Affiliation': 'DUCK FLATS Pharma, Elbridge, New York.'}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Lowenthal', 'Affiliation': 'Pacific Link Consulting, San Diego, California.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Carrazana', 'Affiliation': 'Consultant for Neurelis, Miami, Florida.'}]",Epilepsia,['10.1111/epi.16449']
318,32078469,Effect of acetazolamide on susceptibility to central sleep apnea in chronic spinal cord injury.,"Spinal cord injury (SCI) is an established risk factor for central sleep apnea. Acetazolamide (ACZ), a carbonic anhydrase inhibitor, has been shown to decrease the frequency of central apnea by inducing mild metabolic acidosis. We hypothesized that ACZ would decrease the propensity to develop hypocapnic central apnea and decrease the apneic threshold. We randomized 16 participants with sleep-disordered breathing (8 SCI and 8 able-bodied controls) to receive ACZ (500 mg twice a day for 3 days) or placebo with a 1-wk washout before crossing over to the other drug arm. Study nights included polysomnography and determination of the hypocapnic apneic threshold and CO 2  reserve using noninvasive ventilation. For participants with spontaneous central apnea, CO 2  was administered until central apnea was abolished, and CO 2  reserve was measured as the difference in end-tidal Pco 2  ( P E T C O 2 ) before and after. Steady-state plant gain, the response of end-tidal Pco 2  to changes in ventilation, was calculated from  P E T C O 2  and V̇e ratio during stable sleep. Controller gain, the response of ventilatory drive to changes in end-tidal Pco 2 , was defined as the ratio of change in V̇e between control and hypopnea to the ΔCO 2  during stable non-rapid eye movement sleep. Treatment with ACZ for three days resulted in widening of the CO 2  reserve (-4.0 ± 1.2 vs. -3.0 ± 0.7 mmHg for able-bodied, -3.4 ± 1.9 vs. -2.2 ± 2.2 mmHg for SCI,  P  < 0.0001), and a corresponding decrease in the hypocapnic apnea threshold (28.3 ± 5.2 vs. 37.1 ± 5.6 mmHg for able-bodied, 29.9 ± 5.4 vs. 34.8 ± 6.9 mmHg for SCI,  P  < 0.0001), respectively. ACZ significantly reduced plant gain when compared with placebo (4.1 ± 1.7 vs. 5.4 ± 1.8 mmHg/L min for able-bodied, 4.1 ± 2.0 vs. 5.1 ± 1.7 mmHg·L -1 ·min for SCI,  P  < 0.01). Acetazolamide decreased apnea-hypopnea index (28.8 ± 22.9 vs. 39.3 ± 24.1 events/h;  P  = 0.05), central apnea index (0.6 ± 1.5 vs. 6.3 ± 13.1 events/h;  P  = 0.05), and oxyhemoglobin desaturation index (7.5 ± 8.3 vs. 19.2 ± 15.2 events/h;  P  = 0.01) compared with placebo. Our results suggest that treatment with ACZ decreases susceptibility to hypocapnic central apnea due to decreased plant gain. Acetazolamide may attenuate central sleep apnea and improve nocturnal oxygen saturation, but its clinical utility requires further investigation in a larger sample of patients. NEW & NOTEWORTHY  Tetraplegia is a risk factor for central sleep-disordered breathing (SDB) and is associated with narrow CO 2  reserve (a marker of susceptibility to central apnea). Treatment with high-dose acetazolamide for 3 days decreased susceptibility to hypocapnic central apnea and reduced the frequency of central respiratory events during sleep. Acetazolamide may play a therapeutic role in alleviating central SDB in patients with cervical spinal cord injury, but larger clinical trials are needed.",2020,"ACZ significantly reduced PG when compared to placebo (4.1±1.7 vs 5.4±1.8 mmHg L -1  min for able-bodied, 4.1±2.0 vs 5.1±1.7 mmHg L -1  min for SCI, p<0.01).","['chronic spinal cord injury', '16 participants with sleep-disordered breathing (8 SCI, 8 able-bodied controls) to receive']","['placebo', 'acetazolamide', 'Acetazolamide', 'ACZ', 'Acetazolamide (ACZ']","['central sleep apnea', 'CO 2  reserve', 'oxyhemoglobin desaturation index', 'Steady-state plant gain (PG', 'apnea-hypopnea index', 'PG', 'central apnea index']","[{'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C0851578', 'cui_str': 'Sleep Disorders'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C1299581', 'cui_str': 'Able'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0000981', 'cui_str': 'Acetazolamide'}]","[{'cui': 'C3887547', 'cui_str': 'Central sleep apnea syndrome (disorder)'}, {'cui': 'C1168591', 'cui_str': 'Oxyhaemoglobin'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205361', 'cui_str': 'Steady (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0032098', 'cui_str': 'Plants'}, {'cui': 'C2111846', 'cui_str': 'Apnea-hypopnea index'}, {'cui': 'C0520680', 'cui_str': 'Ondine Syndrome'}]",16.0,0.0364772,"ACZ significantly reduced PG when compared to placebo (4.1±1.7 vs 5.4±1.8 mmHg L -1  min for able-bodied, 4.1±2.0 vs 5.1±1.7 mmHg L -1  min for SCI, p<0.01).","[{'ForeName': 'Geoffrey', 'Initials': 'G', 'LastName': 'Ginter', 'Affiliation': 'John D. Dingell Veterans Affairs Medical Center, Detroit, Michigan.'}, {'ForeName': 'Abdulghani', 'Initials': 'A', 'LastName': 'Sankari', 'Affiliation': 'John D. Dingell Veterans Affairs Medical Center, Detroit, Michigan.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Eshraghi', 'Affiliation': 'John D. Dingell Veterans Affairs Medical Center, Detroit, Michigan.'}, {'ForeName': 'Harold', 'Initials': 'H', 'LastName': 'Obiakor', 'Affiliation': 'John D. Dingell Veterans Affairs Medical Center, Detroit, Michigan.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Yarandi', 'Affiliation': 'Wayne State University, Detroit, Michigan.'}, {'ForeName': 'Susmita', 'Initials': 'S', 'LastName': 'Chowdhuri', 'Affiliation': 'John D. Dingell Veterans Affairs Medical Center, Detroit, Michigan.'}, {'ForeName': 'Anan', 'Initials': 'A', 'LastName': 'Salloum', 'Affiliation': 'John D. Dingell Veterans Affairs Medical Center, Detroit, Michigan.'}, {'ForeName': 'M Safwan', 'Initials': 'MS', 'LastName': 'Badr', 'Affiliation': 'John D. Dingell Veterans Affairs Medical Center, Detroit, Michigan.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00532.2019']
319,32078471,Can whole body vibration exercises promote improvement on quality of life and on chronic pain level of metabolic syndrome patients? A pseudorandomized crossover study.,"Quality of life (QoL) is one of the most important health outcome concepts expressed subjectively. Chronic pain (CP) is an unpleasant sensory and emotional experience associated with actual or potential tissue damage. Taking into account the poor QoL and the CP already described in metabolic syndrome (MSy) individuals, this study aimed to evaluate the effects of whole body vibration exercises (WBVE) on these parameters in this population. Thirty-three MSy patients were divided in  subgroups A  [whole body vibration exercise group (WBVeG),  n  = 17, 15 females/2 males, 61.1 ± 8.4 yr] and  B  (control group,  n  = 16, 14 females/2 males, 58.2 ± 9.1 yr).  Subgroup A  performed 10 sessions (2 times/wk) of WBVE (18 min/session, with a frequency from 5 up to 14 Hz and a peak-to-peak displacement of 2.5, 5.0, and 7.5 mm) on a side-alternating vibrating platform (VP).  Subgroup B  did the same protocol, but the VP was turned off. The individuals answered the World Health Organization Quality of Life bref (WHOQoL-bref) questionnaire before the first and after the 10th session. The chronic pain level (CPL) was measured by a numeric rating scale (0-10) before and at the end of each session. Significant improvements were found in physical health ( P  = 0.05) and psychological health ( P  = 0.04) domains of WHOQoL-bref in WBVeG. A significant acute reduction of the CPL was found in the WBVeG after the protocol, considering the first session and at the last session. WBVE marginally improved physical health and psychological health and decrease the CPL in acute interventions. NEW & NOTEWORTHY  Metabolic syndrome patients experience poor quality of life, frequently associated with lack of exercise and bad dietary habits. Additionally, factors such as obesity, neuromusculoskeletal impairment, and peripheral endothelial dysfunction result in a chronic pain level. Whole body vibration exercise might represent a suitable physical therapy, since it is easy to perform, low cost, safe, and capable of promoting an improvement of quality of life and reducing chronic pain level during acute interventions in metabolic syndrome individuals.",2020,"Significant improvements were found in physical health ( p =0.05) and psychological health ( p =0.04) domains of WHOQoL-bref in WBVeG. A significant acute reduction of the CPL was found in the WBVeG after the protocol, considering the first session (FS) and at the last session (LS).","['Thirty-three MSy patients were divided in subgroup A (WBVeG, n=17, 15 females/02 males, 61.1±8.4 yrs) and B (control group, CG, n=16, 14 females/02 males, 58.2±9.1 yrs']","['WBVE', 'side alternating vibrating platform (VP) (Novaplate, Fitness Evolution ®, São Paulo, Brazil']","['physical health', 'Quality of life (QoL', 'psychological health', 'Chronic pain (CP', 'quality of life', 'physical health and psychological health', 'numeric rating scale (NRS', 'World Health Organization Quality of Life bref (WHOQoL-bref) questionnaire']","[{'cui': 'C0450358', 'cui_str': '33 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0332270', 'cui_str': 'Alternating (qualifier value)'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0034380'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0222045'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",33.0,0.0120132,"Significant improvements were found in physical health ( p =0.05) and psychological health ( p =0.04) domains of WHOQoL-bref in WBVeG. A significant acute reduction of the CPL was found in the WBVeG after the protocol, considering the first session (FS) and at the last session (LS).","[{'ForeName': 'Laisa Liane', 'Initials': 'LL', 'LastName': 'Paineiras-Domingos', 'Affiliation': 'Programa de Pós-Graduação em Ciências Médicas, Universidade do Estado do Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Danúbia da Cunha', 'Initials': 'DDC', 'LastName': 'Sá-Caputo', 'Affiliation': 'Programa de Pós-Graduação em Ciências Médicas, Universidade do Estado do Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Arlete', 'Initials': 'A', 'LastName': 'Francisca-Santos', 'Affiliation': 'Laboratório de Vibrações Mecânicas e Práticas Integrativas, Departamento de Biofísica e Biometria, Instituto de Biologia Roberto Alcântara Gomes e Policlínica Piquet Carneiro, Universidade do Estado do Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Aline', 'Initials': 'A', 'LastName': 'Reis-Silva', 'Affiliation': 'Laboratório de Vibrações Mecânicas e Práticas Integrativas, Departamento de Biofísica e Biometria, Instituto de Biologia Roberto Alcântara Gomes e Policlínica Piquet Carneiro, Universidade do Estado do Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Rafaelle Pacheco', 'Initials': 'RP', 'LastName': 'Carvalho-Lima', 'Affiliation': 'Laboratório de Vibrações Mecânicas e Práticas Integrativas, Departamento de Biofísica e Biometria, Instituto de Biologia Roberto Alcântara Gomes e Policlínica Piquet Carneiro, Universidade do Estado do Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Mario Fritsch T', 'Initials': 'MFT', 'LastName': 'Neves', 'Affiliation': 'Departamento de Clínica Médica do HUPE, Universidade do Estado do Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Vinicius Layter', 'Initials': 'VL', 'LastName': 'Xavier', 'Affiliation': 'Departamento de Estatística, Instituto de Matemática e Estatística, Universidade do Estado do Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Quinart', 'Affiliation': 'Institut de Formation en Masso-kinésithérapie, Reims, France.'}, {'ForeName': 'François Constant', 'Initials': 'FC', 'LastName': 'Boyer', 'Affiliation': 'Physical and Rehabilitation Medicine Department, Sebastopol Hospital, University of Reims Champagne-Ardenne, France.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Sartorio', 'Affiliation': 'Istituto Auxologico Italiano, IRCCS, Experimental Laboratory for Auxo-endocrinological Research, Milan and Verbania, Italy.'}, {'ForeName': 'Redha', 'Initials': 'R', 'LastName': 'Taiar', 'Affiliation': 'University of Reims Champagne-Ardenne, France.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Bernardo-Filho', 'Affiliation': 'Laboratório de Vibrações Mecânicas e Práticas Integrativas, Departamento de Biofísica e Biometria, Instituto de Biologia Roberto Alcântara Gomes e Policlínica Piquet Carneiro, Universidade do Estado do Rio de Janeiro, Rio de Janeiro, Brazil.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00068.2019']
320,32151697,Timing of electronic reminders did not improve trial participant questionnaire response: a randomized trial and meta-analyses.,"OBJECTIVES


The objective of this study was to assess whether timing of short messaging service (SMS) reminders improved postal questionnaire return rates from participants in a randomized controlled trial (RCT).
STUDY DESIGN AND SETTING


A Study Within A Trial (SWAT) embedded in a multicenter RCT evaluating three treatments for the frozen shoulder. Participants who provided a mobile telephone number were randomized to either prenotification SMS on the day of the questionnaire mail-out or postnotification SMS 4 days after questionnaire mail-out for the 3-month follow-up. The primary outcome was the proportion of participants who returned a valid questionnaire. A systematic review was undertaken to identify other embedded trials to perform a meta-analysis.
RESULTS


Of the 269 participants, 122/135 (90.4%) returned a valid questionnaire in the prenotification arm and 119/134 (88.8%) in the postnotification arm (difference of -1.6%; 95% CI of difference: -8.9%, 5.7%). There was no difference in time to response (HR = 1.04; 95% CI: 0.80 to 1.34) or need for additional reminders (OR = 0.71; 95% CI: 0.43 to 1.17). Meta-analysis of two RCTs showed no difference in response rates between prenotification and postnotification reminders (OR = 0.78 95% CI: 0.42 to 1.45).
CONCLUSION


Timing of SMS reminders did not improve response rates and time to response or affect the need for additional reminders.",2020,"Timing of SMS reminders did not improve response rates, time to response or affect the need for additional reminders.",['Participants who provided a mobile telephone number'],"['pre-notification SMS on the day of the questionnaire mail-out or post-notification SMS', 'SMS reminders']","['trial participant questionnaire response', 'valid questionnaire', 'postal questionnaire return rates', 'response rates', 'response rates, time to response or affect the need for additional reminders', 'time to response', 'proportion of participants who returned a valid questionnaire']","[{'cui': 'C1136360', 'cui_str': 'Mobile Phone'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]","[{'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0422202', 'cui_str': 'Notifications (procedure)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}]",269.0,0.247365,"Timing of SMS reminders did not improve response rates, time to response or affect the need for additional reminders.","[{'ForeName': 'Prasanna', 'Initials': 'P', 'LastName': 'Partha Sarathy', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, Heslington, York YO10 5DD, UK.'}, {'ForeName': 'Lucksy', 'Initials': 'L', 'LastName': 'Kottam', 'Affiliation': 'STRIVE, The James Cook University Hospital, South Tees Hospitals NHS Foundation Trust, Marton Road, Middlesbrough, TS4 3BW, UK.'}, {'ForeName': 'Adwoa', 'Initials': 'A', 'LastName': 'Parker', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, Heslington, York YO10 5DD, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Brealey', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, Heslington, York YO10 5DD, UK. Electronic address: stephen.brealey@york.ac.uk.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Coleman', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, Heslington, York YO10 5DD, UK.'}, {'ForeName': 'Ada', 'Initials': 'A', 'LastName': 'Keding', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, Heslington, York YO10 5DD, UK.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Mitchell', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, Heslington, York YO10 5DD, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Northgraves', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, Heslington, York YO10 5DD, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Torgerson', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, Heslington, York YO10 5DD, UK.'}, {'ForeName': 'Amar', 'Initials': 'A', 'LastName': 'Rangan', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, Heslington, York YO10 5DD, UK; STRIVE, The James Cook University Hospital, South Tees Hospitals NHS Foundation Trust, Marton Road, Middlesbrough, TS4 3BW, UK.'}]",Journal of clinical epidemiology,['10.1016/j.jclinepi.2020.03.001']
321,32229173,Perioperative non-invasive haemodynamic optimisation using photoplethysmography: A randomised controlled trial and meta-analysis.,"BACKGROUND


The present study aimed at evaluating the effect of a haemodynamic algorithm using SV maximisation by non-invasive photoplethysmography (interventional group) on the incidence of postoperative complications compared with a control group using intermittent mean arterial pressure.
METHODS


The non-blinded parallel-group trial randomised low-risk patients undergoing colorectal surgery into either interventional group or control group. The primary outcome was the incidence of patients with at least one complication during the 30 days following surgery. The secondary outcomes were the total number of complications, the length of hospital stay and postoperative mortality. A meta-analysis of randomised trials comparing perioperative haemodynamic optimisation (interventional group) using photoplethysmography with control group was performed to assess the external validity.
RESULTS


Among 160 randomised patients, 159 were analysed (80 and 79 in interventional and control groups, respectively). Demographic characteristics were similar in both groups. Postoperative complications occurred in 40 (50%) and 34 (43%) patients in the interventional and control groups, respectively (P=0.471). There were no significant differences between the two groups regarding the total number of complications (P=0.078), the hospital length of stay (P=0.960), or postoperative mortality (P=1.000). In the meta-analysis including 1089 patients in 7 randomised controlled studies, 203 (38%) and 221 (40%) patients suffered from at least one complication following surgery [risk ratio 0.89 (95% CI 0.68-1.17), P=0.407] in interventional and control groups, respectively.
CONCLUSIONS


Based on the findings of the present study and meta-analysis, a haemodynamic perioperative algorithm using SV maximisation by non-invasive photoplethysmography cannot reduce postoperative morbidity.",2020,"There were no significant differences between the two groups regarding the total number of complications (P = 0.078), the hospital length of stay (P = 0.960), or postoperative mortality (P = 1,000).","['160 patients randomised, 159 were analysed (80 and 79 in interventional and control groups, respectively', 'risk patients undergoing colorectal surgery into either interventional group or control group']","['Perioperative non-invasive haemodynamic optimisation using photoplethysmography', 'haemodynamic algorithm using SV maximisation by non-invasive photoplethysmography (interventional group']","['Postoperative complications', 'incidence of patients with at least one complication', 'Demographic characteristics', 'postoperative morbidity', 'postoperative complications', 'total number of complications', 'total number of complications, the length of hospital stay and postoperative mortality', 'hospital length of stay', 'postoperative mortality']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0009369', 'cui_str': 'Colon and Rectal Surgery Specialty'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0205303', 'cui_str': 'Non-invasive (qualifier value)'}, {'cui': 'C0162599', 'cui_str': 'Light Reflection Rheography'}, {'cui': 'C0002045'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",,0.201676,"There were no significant differences between the two groups regarding the total number of complications (P = 0.078), the hospital length of stay (P = 0.960), or postoperative mortality (P = 1,000).","[{'ForeName': 'Marc-Olivier', 'Initials': 'MO', 'LastName': 'Fischer', 'Affiliation': ""UNICAEN, service d'anesthésie réanimation, Normandie université, CHU de Caen Normandie, 14000 Caen, France. Electronic address: marcolivierfischer@yahoo.fr.""}, {'ForeName': 'Anne-Lise', 'Initials': 'AL', 'LastName': 'Fiant', 'Affiliation': ""UNICAEN, service d'anesthésie réanimation, Normandie université, CHU de Caen Normandie, 14000 Caen, France.""}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Debroczi', 'Affiliation': ""UNICAEN, service d'anesthésie réanimation, Normandie université, CHU de Caen Normandie, 14000 Caen, France.""}, {'ForeName': 'Mariam', 'Initials': 'M', 'LastName': 'Boutros', 'Affiliation': ""UNICAEN, service d'anesthésie réanimation, Normandie université, CHU de Caen Normandie, 14000 Caen, France.""}, {'ForeName': 'Léa', 'Initials': 'L', 'LastName': 'Pasqualini', 'Affiliation': ""UNICAEN, service d'anesthésie réanimation, Normandie université, CHU de Caen Normandie, 14000 Caen, France.""}, {'ForeName': 'Marguerite', 'Initials': 'M', 'LastName': 'Demonchy', 'Affiliation': ""UNICAEN, service d'anesthésie réanimation, Normandie université, CHU de Caen Normandie, 14000 Caen, France.""}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Flais', 'Affiliation': ""UNICAEN, service d'anesthésie réanimation, Normandie université, CHU de Caen Normandie, 14000 Caen, France.""}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Alves', 'Affiliation': 'UNICAEN, service de chirurgie digestive, Normandie université, CHU de Caen Normandie, 14000 Caen, France.'}, {'ForeName': 'Jean-Louis', 'Initials': 'JL', 'LastName': 'Gérard', 'Affiliation': ""UNICAEN, service d'anesthésie réanimation, Normandie université, CHU de Caen Normandie, 14000 Caen, France.""}, {'ForeName': 'Clément', 'Initials': 'C', 'LastName': 'Buléon', 'Affiliation': ""UNICAEN, service d'anesthésie réanimation, Normandie université, CHU de Caen Normandie, 14000 Caen, France.""}, {'ForeName': 'Jean-Luc', 'Initials': 'JL', 'LastName': 'Hanouz', 'Affiliation': ""UNICAEN, service d'anesthésie réanimation, Normandie université, CHU de Caen Normandie, 14000 Caen, France.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Anaesthesia, critical care & pain medicine",['10.1016/j.accpm.2020.03.016']
322,31690602,Study to Weigh the Effect of Exercise Training on BONE quality and strength (SWEET BONE) in type 2 diabetes: study protocol for a randomised clinical trial.,"INTRODUCTION


Type 2 diabetes (T2D) is associated with an increased fracture risk despite normal-to-increased bone mineral density, suggesting reduced bone quality. Exercise may be effective in reducing fracture risk by ameliorating muscle dysfunction and reducing risk of fall, though it is unclear whether it can improve bone quality.
METHODS AND ANALYSIS


The 'Study to Weigh the Effect of Exercise Training on BONE quality and strength (SWEET BONE) in T2D' is an open-label, assessor-blinded, randomised clinical trial comparing an exercise training programme of 2-year duration, specifically designed for improving bone quality and strength, with standard care in T2D individuals. Two hundred T2D patients aged 65-75 years will be randomised 1:1 to supervised exercise training or standard care, stratified by gender, age ≤ or >70 years and non-insulin or insulin treatment. The intervention consists of two weekly supervised sessions, each starting with 5 min of warm-up, followed by 20 min of aerobic training, 30 min of resistance training and 20 min of core stability, balance and flexibility training. Participants will wear weighted vests during aerobic and resistance training. The primary endpoint is baseline to end-of-study change in trabecular bone score, a parameter of bone quality consistently shown to be reduced in T2D. Secondary endpoints include changes in other potential measures of bone quality, as assessed by quantitative ultrasound and peripheral quantitative CT; bone mass; markers of bone turnover; muscle strength, mass and power; balance and gait. Falls and asymptomatic and symptomatic fractures will be evaluated over 7 years, including a 5-year post-trial follow-up. The superiority of the intervention will be assessed by comparing between-groups baseline to end-of-study changes.
ETHICS AND DISSEMINATION


This study was approved by the institutional ethics committee. Written informed consent will be obtained from all participants. The study results will be submitted for peer-reviewed publication.
TRIAL REGISTRATION NUMBER


NCT02421393; Pre-results.",2019,"Exercise may be effective in reducing fracture risk by ameliorating muscle dysfunction and reducing risk of fall, though it is unclear whether it can improve bone quality.
","['type 2 diabetes', 'Two hundred', 'patients aged 65-75 years', 'T2D individuals']","['exercise training programme', 'T2D', 'aerobic training, 30\u2009min of resistance training and 20\u2009min of core stability, balance and flexibility training', 'supervised exercise training or standard care, stratified by gender, age ≤ or >70 years and non-insulin or insulin treatment', 'Exercise Training']","['Falls and asymptomatic and symptomatic fractures', 'bone quality, as assessed by quantitative ultrasound and peripheral quantitative CT; bone mass; markers of bone turnover; muscle strength, mass and power; balance and gait', 'BONE quality and strength (SWEET BONE', 'baseline to end-of-study change in trabecular bone score, a parameter of bone quality', 'bone quality and strength']","[{'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0085268', 'cui_str': 'Bone Turnover'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0453447', 'cui_str': 'Sugar candy'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0222660', 'cui_str': 'Spongy Bone'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",200.0,0.120821,"Exercise may be effective in reducing fracture risk by ameliorating muscle dysfunction and reducing risk of fall, though it is unclear whether it can improve bone quality.
","[{'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Balducci', 'Affiliation': 'Department of Clinical and Molecular Medicine, La Sapienza University, Rome, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Conti', 'Affiliation': 'Department of Clinical and Molecular Medicine, La Sapienza University, Rome, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Sacchetti', 'Affiliation': 'Department of Human Movement and Sport Sciences, Foro Italico University, Rome, Italy.'}, {'ForeName': 'Cosimo R', 'Initials': 'CR', 'LastName': 'Russo', 'Affiliation': 'Metagym Fitness Centre, Florence, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Argento', 'Affiliation': ""Radiology Unit, Sant'Andrea University Hospital, Rome, Italy.""}, {'ForeName': 'Jonida', 'Initials': 'J', 'LastName': 'Haxhi', 'Affiliation': ""Diabetes Unit, Sant'Andrea University Hospital, Rome, Italy.""}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Orlando', 'Affiliation': 'Department of Human Movement and Sport Sciences, Foro Italico University, Rome, Italy.'}, {'ForeName': 'Gianvito', 'Initials': 'G', 'LastName': 'Rapisarda', 'Affiliation': ""Diabetes Unit, Sant'Andrea University Hospital, Rome, Italy.""}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': ""D'Errico"", 'Affiliation': ""Diabetes Unit, Sant'Andrea University Hospital, Rome, Italy.""}, {'ForeName': 'Patrizia', 'Initials': 'P', 'LastName': 'Cardelli', 'Affiliation': 'Department of Clinical and Molecular Medicine, La Sapienza University, Rome, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Pugliese', 'Affiliation': ""Radiology Unit, Sant'Andrea University Hospital, Rome, Italy.""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Laghi', 'Affiliation': ""Radiology Unit, Sant'Andrea University Hospital, Rome, Italy.""}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Vitale', 'Affiliation': 'Department of Clinical and Molecular Medicine, La Sapienza University, Rome, Italy.'}, {'ForeName': 'Lucilla', 'Initials': 'L', 'LastName': 'Bollanti', 'Affiliation': 'Department of Clinical and Molecular Medicine, La Sapienza University, Rome, Italy.'}, {'ForeName': 'Silvano', 'Initials': 'S', 'LastName': 'Zanuso', 'Affiliation': 'Centre for Applied Biological & Exercise Sciences, Faculty of Health & Life Sciences, Coventry University, Coventry, UK.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Nicolucci', 'Affiliation': 'Centre for Outcomes Research and Clinical Epidemiology (CORESEARCH), Pescara, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Pugliese', 'Affiliation': 'Department of Clinical and Molecular Medicine, La Sapienza University, Rome, Italy giuseppe.pugliese@uniroma1.it.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2018-027429']
323,31289334,The effects of exercise session timing on weight loss and components of energy balance: midwest exercise trial 2.,"BACKGROUND/OBJECTIVES


Circadian physiology has been linked to body weight regulation and obesity. To date, few studies have assessed the association between exercise timing and weight related outcomes. The aim of this secondary analysis was to explore the impact of exercise timing (i.e., 24 h clock time of exercise session) on weight loss and components of energy balance.
SUBJECTS/METHODS


Overweight/obese (BMI 25.0-39.9 kg/m 2 ), physically inactive, young adults (~51% female) completed a 10-month supervised exercise program (400 or 600 kcal/session for 5 days/week) or served as non-exercise controls (CON). Participants were categorized based on the time of day in which they completed exercise sessions (Early-Ex: >50% of sessions completed between 7:00 and 11:59 am; (n = 21), Late-Ex: >50% of sessions completed between 3:00 and 7:00 pm; (n = 25), Sporadic-Ex: <50% of sessions completed in any time category; (n = 24), and CON; (n = 18)). Body weight, energy intake (EI; digital photography), and non-exercise physical activity (NEPA; accelerometer) were assessed at baseline, 3.5, 7, and 10 months. Total daily energy expenditure (TDEE; doubly labeled water), was assessed at baseline and 10 months.
RESULTS


At month 10, weight loss was significantly greater in both Early-EX (-7.2 ± 1.2%; p < 0.001) and Sporadic-EX (- 5.5 ± 1.2%; p = 0.01) vs CON (+0.5 ± 1.0%), and Early-EX vs Late-EX (-2.1 ± 1.0%; p < 0.001). There were no between group differences for change in TDEE, EI, and non-exercise energy expenditure (P > 0.05). A significant group × time interaction (p = 0.02) was observed for NEPA (counts/min), however, after adjusting for multiple comparisons, group effects were no longer significant.
CONCLUSIONS


Despite minimal differences in components of energy balance, Early-EX lost significantly more weight compared with Late-Ex. Although the mechanisms are unclear, the timing of exercise may be important for body weight regulation.",2020,"A significant group × time interaction (p = 0.02) was observed for NEPA (counts/min), however, after adjusting for multiple comparisons, group effects were no longer significant.
","['Overweight/obese (BMI 25.0-39.9\u2009kg/m 2 ), physically inactive, young adults (~51% female']","['exercise session', 'supervised exercise program (400 or 600\u2009kcal/session for 5 days/week) or served as non-exercise controls (CON', 'CON']","['Total daily energy expenditure (TDEE; doubly labeled water', 'time interaction', 'weight loss', 'Body weight, energy intake (EI; digital photography), and non-exercise physical activity (NEPA; accelerometer', 'change in TDEE, EI, and non-exercise energy expenditure', 'weight loss and components of energy balance']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0439259', 'cui_str': 'kilocalorie'}, {'cui': 'C0677547', 'cui_str': 'days/week (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0014272', 'cui_str': 'Energy Expenditure'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0031749', 'cui_str': 'Photography'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}]",,0.0725595,"A significant group × time interaction (p = 0.02) was observed for NEPA (counts/min), however, after adjusting for multiple comparisons, group effects were no longer significant.
","[{'ForeName': 'Erik A', 'Initials': 'EA', 'LastName': 'Willis', 'Affiliation': 'Center for Health Promotion and Disease Prevention, University of North Carolina-Chapel Hill, Chapel Hill, NC, USA. erik.willis@unc.edu.'}, {'ForeName': 'Seth A', 'Initials': 'SA', 'LastName': 'Creasy', 'Affiliation': 'Division of Endocrinology, Metabolism, and Diabetes, Anschutz Medical Campus, University of Colorado Aurora, Aurora, CO, USA.'}, {'ForeName': 'Jeffery J', 'Initials': 'JJ', 'LastName': 'Honas', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Edward L', 'Initials': 'EL', 'LastName': 'Melanson', 'Affiliation': 'Division of Endocrinology, Metabolism, and Diabetes, Anschutz Medical Campus, University of Colorado Aurora, Aurora, CO, USA.'}, {'ForeName': 'Joseph E', 'Initials': 'JE', 'LastName': 'Donnelly', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, Kansas City, KS, USA.'}]",International journal of obesity (2005),['10.1038/s41366-019-0409-x']
324,31292457,Hepatic triglyceride content does not affect circulating CETP: lessons from a liraglutide intervention trial and a population-based cohort.,"Cholesteryl ester transfer protein (CETP) is mainly expressed by Kupffer cells in the liver. A reduction of hepatic triglyceride content (HTGC) by pioglitazone or caloric restriction is accompanied by a decrease in circulating CETP. Since GLP-1 analogues also reduce HTGC, we assessed whether liraglutide decreases CETP. Furthermore, we investigated the association between HTGC and CETP in a population-based cohort. In a placebo-controlled trial, 50 patients with type 2 diabetes were randomly assigned to treatment with liraglutide or placebo added to standard care. In this trial and in 1,611 participants of the Netherlands Epidemiology of Obesity (NEO) study, we measured HTGC and circulating CETP by proton magnetic resonance spectroscopy and ELISA, respectively. The HTGC was decreased in the liraglutide group (-6.3%; 95%CI of difference [-9.5, -3.0]) but also in the placebo group (-4.0%; 95%CI[-6.0, -2.0]), without between-group differences. CETP was not decreased by liraglutide (-0.05 µg/mL; 95%CI[-0.13, 0.04]) or placebo (-0.04 µg/mL; 95%CI[-0.12, 0.04]). No association was present between HTGC and CETP at baseline (β: 0.002 µg/mL per %TG, 95%CI[-0.005, 0.009]) and between the changes after treatment with liraglutide (β: 0.003 µg/mL per %TG, 95%CI[-0.010, 0.017]) or placebo (β: 0.006 µg/mL per %TG, 95%CI[-0.012,0.024]). Also, in the cohort n o association between HTGC and CETP was present (β: -0.001 µg/mL per SD TG, 95%CI[-0.005, 0.003]). A reduction of HTGC after treatment with liraglutide or placebo does not decrease circulating CETP. Also, no association between HTGC and CETP was present in a large cohort. These findings indicate that circulating CETP is not determined by HTGC.Clinical Trial Registration: Clinicaltrials.gov (NCT01761318).",2019,A reduction of hepatic triglyceride content (HTGC) by pioglitazone or caloric restriction is accompanied by a decrease in circulating CETP.,"['1,611 participants of the Netherlands Epidemiology of Obesity (NEO', '50 patients with type 2 diabetes']","['Cholesteryl ester transfer protein (CETP', 'liraglutide or placebo', 'HTGC and CETP', 'liraglutide', 'placebo', 'pioglitazone', 'HTGC', 'liraglutide or placebo added to standard care']","['hepatic triglyceride content (HTGC', 'circulating CETP', 'HTGC', 'Hepatic triglyceride content', 'CETP']","[{'cui': 'C0014507', 'cui_str': 'Epidemiology'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0055538', 'cui_str': 'Cholesterol Ester Transport Protein, CETP'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0071097', 'cui_str': 'pioglitazone'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}]",1611.0,0.455577,A reduction of hepatic triglyceride content (HTGC) by pioglitazone or caloric restriction is accompanied by a decrease in circulating CETP.,"[{'ForeName': 'Huub J', 'Initials': 'HJ', 'LastName': 'van Eyk', 'Affiliation': 'Department Medicine, Div. Endocrinology, Leiden University Medical Center (LUMC), Leiden, The Netherlands. H.J.van_Eyk@lumc.nl.'}, {'ForeName': 'Lisanne L', 'Initials': 'LL', 'LastName': 'Blauw', 'Affiliation': 'Department Medicine, Div. Endocrinology, Leiden University Medical Center (LUMC), Leiden, The Netherlands.'}, {'ForeName': 'Maurice B', 'Initials': 'MB', 'LastName': 'Bizino', 'Affiliation': 'Department Medicine, Div. Endocrinology, Leiden University Medical Center (LUMC), Leiden, The Netherlands.'}, {'ForeName': 'Yanan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department Medicine, Div. Endocrinology, Leiden University Medical Center (LUMC), Leiden, The Netherlands.'}, {'ForeName': 'Ko Willems', 'Initials': 'KW', 'LastName': 'van Dijk', 'Affiliation': 'Department Medicine, Div. Endocrinology, Leiden University Medical Center (LUMC), Leiden, The Netherlands.'}, {'ForeName': 'Renée', 'Initials': 'R', 'LastName': 'de Mutsert', 'Affiliation': 'Department Epidemiology, LUMC, Leiden, The Netherlands.'}, {'ForeName': 'Johannes W A', 'Initials': 'JWA', 'LastName': 'Smit', 'Affiliation': 'Department Medicine, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Hildo J', 'Initials': 'HJ', 'LastName': 'Lamb', 'Affiliation': 'Department Radiology, LUMC, Leiden, The Netherlands.'}, {'ForeName': 'Ingrid M', 'Initials': 'IM', 'LastName': 'Jazet', 'Affiliation': 'Department Medicine, Div. Endocrinology, Leiden University Medical Center (LUMC), Leiden, The Netherlands.'}, {'ForeName': 'Patrick C N', 'Initials': 'PCN', 'LastName': 'Rensen', 'Affiliation': 'Department Medicine, Div. Endocrinology, Leiden University Medical Center (LUMC), Leiden, The Netherlands.'}]",Scientific reports,['10.1038/s41598-019-45593-2']
325,31292531,One-year postpartum anthropometric outcomes in mothers and children in the LIFE-Moms lifestyle intervention clinical trials.,"BACKGROUND/OBJECTIVES


Excess gestational weight gain (GWG) is a risk factor for maternal postpartum weight retention and excessive neonatal adiposity, especially in women with overweight or obesity. Whether lifestyle interventions to reduce excess GWG also reduce 12-month maternal postpartum weight retention and infant weight-for-length z score is unknown. Randomized controlled trials from the LIFE-Moms consortium investigated lifestyle interventions that began in pregnancy and tested whether there was benefit through 12 months on maternal postpartum weight retention (i.e., the difference in weight from early pregnancy to 12 months) and infant-weight-for-length z scores.
SUBJECTS/METHODS


In LIFE-Moms, women (N = 1150; 14.1 weeks gestation at enrollment) with overweight or obesity were randomized within each of seven trials to lifestyle intervention or standard care. Individual participant data were combined and analyzed using generalized linear mixed models with trial entered as a random effect. The 12-month assessment was completed by 83% (959/1150) of women and 84% (961/1150) of infants.
RESULTS


Compared with standard care, lifestyle intervention reduced postpartum weight retention (2.2 ± 7.0 vs. 0.7 ± 6.2 kg, respectively; difference of -1.6 kg (95% CI -2.5, -0.7; p = 0.0003); the intervention effect was mediated by reduction in excess GWG, which explained 22% of the effect on postpartum weight retention. Lifestyle intervention also significantly increased the odds (OR = 1.68 (95% CI, 1.26, 2.24)) and percentage of mothers (48.2% vs. 36.2%) at or below baseline weight at 12 months postpartum (yes/no) compared with standard care. There was no statistically significant treatment group effect on infant anthropometric outcomes at 12 months.
CONCLUSIONS


Compared with standard care, lifestyle interventions initiated in pregnancy and focused on healthy eating, increased physical activity, and other behavioral strategies resulted in significantly less weight retention but similar infant anthropometric outcomes at 12 months postpartum in a large, diverse US population of women with overweight and obesity.",2020,"Lifestyle intervention also significantly increased the odds (OR = 1.68 (95% CI, 1.26, 2.24)) and percentage of mothers (48.2% vs. 36.2%) at or below baseline weight at 12 months postpartum (yes/no) compared with standard care.","['women (N\u2009=\u20091150; 14.1 weeks gestation at enrollment) with overweight or obesity', 'mothers and children in the LIFE-Moms lifestyle intervention clinical trials', 'women with overweight or obesity']","['lifestyle intervention or standard care', 'LIFE-Moms consortium investigated lifestyle interventions']","['maternal postpartum weight retention and infant weight-for-length z score', 'infant anthropometric outcomes', 'weight retention', 'infant-weight-for-length z scores', 'postpartum weight retention', 'maternal postpartum weight retention']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C1442163', 'cui_str': 'Multiple of the median'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}]","[{'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C1442163', 'cui_str': 'Multiple of the median'}, {'cui': 'C1292732', 'cui_str': 'Investigates'}]","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C4704811', 'cui_str': 'Postpartum Weight Retention'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0035280', 'cui_str': 'Retention'}]",1150.0,0.182381,"Lifestyle intervention also significantly increased the odds (OR = 1.68 (95% CI, 1.26, 2.24)) and percentage of mothers (48.2% vs. 36.2%) at or below baseline weight at 12 months postpartum (yes/no) compared with standard care.","[{'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Phelan', 'Affiliation': 'Department of Kinesiology & Public Health, California Polytechnic State University, San Luis Obispo, CA, USA. sphelan@calpoly.edu.'}, {'ForeName': 'Rebecca G', 'Initials': 'RG', 'LastName': 'Clifton', 'Affiliation': 'The Biostatistics Center, George Washington University, Washington, DC, USA.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Haire-Joshu', 'Affiliation': 'Center for Diabetes Translation Research, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Leanne M', 'Initials': 'LM', 'LastName': 'Redman', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Van Horn', 'Affiliation': 'Department of Preventive Medicine, Northwestern University, Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Evans', 'Affiliation': 'The National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, USA.'}, {'ForeName': 'Kaumudi', 'Initials': 'K', 'LastName': 'Joshipura', 'Affiliation': 'Center for Clinical Research and Health Promotion, School of Dental Medicine, Medical Sciences Campus, University of Puerto Rico, San Juan, Puerto Rico.'}, {'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Couch', 'Affiliation': 'Phoenix Indian Medical Center, Indian Health Service, Phoenix, AZ, USA.'}, {'ForeName': 'S Sonia', 'Initials': 'SS', 'LastName': 'Arteaga', 'Affiliation': 'The National Heart, Lung, and Blood Institute, Bethesda, MD, USA.'}, {'ForeName': 'Alison G', 'Initials': 'AG', 'LastName': 'Cahill', 'Affiliation': 'Department of Obstetrics and Gynecology, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Kimberly L', 'Initials': 'KL', 'LastName': 'Drews', 'Affiliation': 'The Biostatistics Center, George Washington University, Washington, DC, USA.'}, {'ForeName': 'Paul W', 'Initials': 'PW', 'LastName': 'Franks', 'Affiliation': 'Department of Nutrition, Harvard T.H. Chan Public Health School, Harvard University, Boston, MA, USA.'}, {'ForeName': 'Dympna', 'Initials': 'D', 'LastName': 'Gallagher', 'Affiliation': 'New York Obesity Research Center, Dept. of Medicine, College of Physicians and Surgeons, Columbia University, New York, NY, USA.'}, {'ForeName': 'Jami L', 'Initials': 'JL', 'LastName': 'Josefson', 'Affiliation': 'Department of Pediatrics, Northwestern University, Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Klein', 'Affiliation': 'Center for Human Nutrition, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Knowler', 'Affiliation': 'Diabetes Epidemiology and Clinical Research Section, National Institute of Diabetes and Digestive and Kidney Diseases, Phoenix, AZ, USA.'}, {'ForeName': 'Corby K', 'Initials': 'CK', 'LastName': 'Martin', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, USA.'}, {'ForeName': 'Alan M', 'Initials': 'AM', 'LastName': 'Peaceman', 'Affiliation': 'Department of Obstetrics and Gynecology, Northwestern University, Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Thom', 'Affiliation': 'The Biostatistics Center, George Washington University, Washington, DC, USA.'}, {'ForeName': 'Rena R', 'Initials': 'RR', 'LastName': 'Wing', 'Affiliation': 'The Miriam Hospital and the Department of Psychiatry and Human Behavior, Warren Alpert Medical School at Brown University, Providence, RI, USA.'}, {'ForeName': 'Susan Z', 'Initials': 'SZ', 'LastName': 'Yanovski', 'Affiliation': 'The National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, USA.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Pi-Sunyer', 'Affiliation': 'New York Obesity Research Center, Dept. of Medicine, College of Physicians and Surgeons, Columbia University, New York, NY, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",International journal of obesity (2005),['10.1038/s41366-019-0410-4']
326,31296884,Quantification of the flux of tyrosine pathway metabolites during nitisinone treatment of Alkaptonuria.,"Nitisinone decreases homogentisic acid (HGA) in Alkaptonuria (AKU) by inhibiting the tyrosine metabolic pathway in humans. The effect of different daily doses of nitisinone on circulating and 24 h urinary excretion of phenylalanine (PA), tyrosine (TYR), hydroxyphenylpyruvate (HPPA), hydroxyphenyllactate (HPLA) and HGA in patients with AKU was studied over a four week period. Forty AKU patients, randomised into five groups of eight patients, received doses of 1, 2, 4 or 8 mg of nitisinone daily, or no drug (control). Metabolites were analysed by tandem mass spectrometry in 24 h urine and serum samples collected before and after nitisinone. Serum metabolites were corrected for total body water and the sum of 24 hr urine plus total body water metabolites of PA, TYR, HPPA, HPLA and HGA were determined. Body weight and urine urea were used to check on stability of diet and metabolism over the 4 weeks of study. The sum of quantities of urine metabolites (PA, TYR, HPPA, HPLA and HGA) were similar pre- and post-nitisinone. The sum of total body water metabolites were significantly higher post-nitisinone (p < 0.0001) at all doses. Similarly, combined 24 hr urine:total body water ratios for all analytes were significantly higher post-nitisinone, compared with pre-nitisinone baseline for all doses (p = 0.0002 - p < 0.0001). Significantly higher concentrations of metabolites from the tyrosine metabolic pathway were observed in a dose dependant manner following treatment with nitisinone and we speculate that, for the first time, experimental evidence of the metabolite pool that would otherwise be directed towards pigment formation, has been unmasked.",2019,The sum of total body water metabolites were significantly higher post-nitisinone (p < 0.0001) at all doses.,"['patients with AKU', 'Forty AKU patients']","['nitisinone daily, or no drug (control', 'nitisinone']","['total body water metabolites', 'urine:total body water ratios', 'quantities of urine metabolites (PA, TYR, HPPA, HPLA and HGA', 'Serum metabolites', 'Body weight and urine urea', 'circulating and 24\u2009h urinary excretion of phenylalanine (PA), tyrosine (TYR), hydroxyphenylpyruvate (HPPA), hydroxyphenyllactate (HPLA) and HGA']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0173083', 'cui_str': 'nitisinone'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0429632', 'cui_str': 'Total body water (observable entity)'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0042037'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1265611', 'cui_str': 'Quantity finding'}, {'cui': 'C0147288', 'cui_str': 'Tyr(TMA)'}, {'cui': 'C0048391', 'cui_str': 'para-hydroxyphenyllactic acid'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0070525', 'cui_str': 'phenacemide'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0031453', 'cui_str': 'L-phenylalanine'}, {'cui': 'C0041485', 'cui_str': 'L-tyrosine'}]",,0.0305042,The sum of total body water metabolites were significantly higher post-nitisinone (p < 0.0001) at all doses.,"[{'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Milan', 'Affiliation': 'Department of Clinical Biochemistry and Metabolic Medicine, Liverpool Clinical Laboratories, Royal Liverpool University Hospital, Prescot Street, Liverpool, L7 8XP, UK. anna.milan@rlbuht.nhs.uk.'}, {'ForeName': 'A T', 'Initials': 'AT', 'LastName': 'Hughes', 'Affiliation': 'Department of Clinical Biochemistry and Metabolic Medicine, Liverpool Clinical Laboratories, Royal Liverpool University Hospital, Prescot Street, Liverpool, L7 8XP, UK.'}, {'ForeName': 'A S', 'Initials': 'AS', 'LastName': 'Davison', 'Affiliation': 'Department of Clinical Biochemistry and Metabolic Medicine, Liverpool Clinical Laboratories, Royal Liverpool University Hospital, Prescot Street, Liverpool, L7 8XP, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Khedr', 'Affiliation': 'Department of Clinical Biochemistry and Metabolic Medicine, Liverpool Clinical Laboratories, Royal Liverpool University Hospital, Prescot Street, Liverpool, L7 8XP, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Rovensky', 'Affiliation': 'National Institute of Rheumatic Diseases, Piestany, Slovakia.'}, {'ForeName': 'E E', 'Initials': 'EE', 'LastName': 'Psarelli', 'Affiliation': 'Liverpool Cancer Trials Unit, University of Liverpool, Block C, Waterhouse Building, Liverpool, L69 3GL, UK.'}, {'ForeName': 'T F', 'Initials': 'TF', 'LastName': 'Cox', 'Affiliation': 'Liverpool Cancer Trials Unit, University of Liverpool, Block C, Waterhouse Building, Liverpool, L69 3GL, UK.'}, {'ForeName': 'N P', 'Initials': 'NP', 'LastName': 'Rhodes', 'Affiliation': 'Department of Musculoskeletal Biology, University of Liverpool, L7 8TX, Liverpool, UK.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Gallagher', 'Affiliation': 'Department of Musculoskeletal Biology, University of Liverpool, L7 8TX, Liverpool, UK.'}, {'ForeName': 'L R', 'Initials': 'LR', 'LastName': 'Ranganath', 'Affiliation': 'Department of Clinical Biochemistry and Metabolic Medicine, Liverpool Clinical Laboratories, Royal Liverpool University Hospital, Prescot Street, Liverpool, L7 8XP, UK.'}]",Scientific reports,['10.1038/s41598-019-46033-x']
327,32200009,"A randomized clinical trial investigating three vital tooth bleaching protocols and associated efficacy, effectiveness and participants' satisfaction.","OBJECTIVES


To compare tooth colour change and participant's satisfaction following: home (HB), in-office (IOB) and combined (CB) bleaching treatments.
METHODS


A group of 105 participants received HB, IOB and CB treatments. HB was performed using custom-made trays and 10 % carbamide peroxide for 14 days. IOB was performed using 37.5 % hydrogen peroxide applied in 3 cycles. CB bleaching treatment involved IOB followed by HB. Tooth colour change was assessed visually (VC-ΔVC) and using a digital spectrophotometry device (ES-ΔeVS). Participant's perception of oral health, smile and straightness and whiteness of teeth were evaluated using self-reported questionnaire. Parameters/responses were evaluated/collected prior bleaching and at recalls. Linear mixed models were used to estimate between- and within-group differences.
RESULTS


CB resulted in significantly higher shade difference at 15 days recall (ΔVC and ΔeVS, all p ≤ 0.046). At 6 months recall, CB group demonstrated higher ΔeVS compared to IOB (p = 0.018) but the difference was not significant between the same groups when using VC (p = 0.051). Significant colour improvement was observed among all groups at 6 months recall (all within-group p < 0.001) except older participants (≥40 years) who received HB (ΔeVS: within-group p = 0.060). Overall, self-perception of oral health and satisfaction with smile and whiteness of teeth were significantly improved in all groups (all within-group p ≤ 0.001). Satisfaction levels with straightness of teeth were significantly improved for CB and IOB overall and in younger (<40 years) participants (all within-group p ≤ 0.013).
CONCLUSION


CB treatment resulted in a pronounced colour improvement when compared to both techniques used individually. All bleaching protocols resulted in significant improvement of participants' perceived oral health and satisfaction with smile and whiteness of teeth.
CLINICAL SIGNIFICANCE


Accelerated whitening can be achieved using a combination of in-office and home bleaching. Patients who may accept gradual whitening of teeth can be treated effectively using a cost-effective protocol and less concentrated bleaching agents.",2020,"All bleaching protocols resulted in significant improvement of participants' perceived oral health and satisfaction with smile and whiteness of teeth.
",[],"['HB, IOB and CB treatments', 'CB bleaching', ' home (HB), in-office (IOB) and combined (CB) bleaching treatments', 'hydrogen peroxide']","['Satisfaction levels', 'IOB', ""Patient's perception of oral health, smile and straightness and whiteness of teeth"", 'Significant colour improvement', 'oral health and satisfaction with smile and whiteness of teeth', 'Overall, self-perception of oral health and satisfaction with smile and whiteness of teeth']",[],"[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0442603', 'cui_str': 'Office (environment)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0020281', 'cui_str': 'Hydrogen Peroxide'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0029162'}, {'cui': 'C0037363', 'cui_str': 'Smilings'}, {'cui': 'C0040426', 'cui_str': 'Tooth'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242498', 'cui_str': 'Self-Perception'}]",105.0,0.0374345,"All bleaching protocols resulted in significant improvement of participants' perceived oral health and satisfaction with smile and whiteness of teeth.
","[{'ForeName': 'Siddharth', 'Initials': 'S', 'LastName': 'Kothari', 'Affiliation': 'University of Otago, Faculty of Dentistry, 310 Great King Street, Dunedin 9016, New Zealand.'}, {'ForeName': 'Ahmad A', 'Initials': 'AA', 'LastName': ""Jum'ah"", 'Affiliation': 'Jordan University of Science and Technology, Faculty of Dentistry, Department of Conservative Dentistry, Irbid 22110, Jordan. Electronic address: aajuma@just.edu.jo.'}, {'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Gray', 'Affiliation': 'University of Otago, Centre for Biostatistics, Division of Health Sciences, 310 Great King Street, Dunedin 9016, New Zealand.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'M Lyons', 'Affiliation': 'University of Otago, Faculty of Dentistry, 310 Great King Street, Dunedin 9016, New Zealand.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Yap', 'Affiliation': 'University of Otago, Faculty of Dentistry, 310 Great King Street, Dunedin 9016, New Zealand.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Brunton', 'Affiliation': 'University of Otago, Faculty of Dentistry, 310 Great King Street, Dunedin 9016, New Zealand.'}]",Journal of dentistry,['10.1016/j.jdent.2020.103322']
328,32169479,Short-term effects of stain-causing beverages on tooth bleaching: A randomized controlled clinical trial.,"OBJECTIVES


To evaluate the short-term effects of stain-causing beverages on the effectiveness of in-office tooth bleaching.
METHODS


Participants were recruited and randomly divided into 3 groups based on beverages used for rinsing during and after the bleaching procedure: group N (tap water, control group), group C (coffee), and group T (tea). Participants were instructed to rinse with the respective solutions for 30 s, 4 times daily for 4 weeks. All participants received two in-office bleaching treatment sessions with 40 % hydrogen peroxide (Opalescence BOOST PF 40 %, Ultradent); the sessions were separated by a 1-week interval. Tooth colour was assessed using a spectrophotometer (Easyshade, Vita ZahnFabrik) before the bleaching procedure (T0), immediately after the first session of bleaching (T1), immediately after the second session of bleaching (T2), as well as one week (T3) and three weeks after (T4) the end of bleaching. Tooth sensitivity (TS) was ranked using a numerical rating scale (NRS) and a visual analogue scale (VAS) at different time points.
RESULTS


No significant difference in the whiteness index (W), △E, △a* and △b* values among the 3 groups was observed at any time interval (P for all > 0.05). At T4, the △L* value in group C was significantly lower than that in groups T and N (P = 0.022 and P = 0.001, respectively), though no significant difference in △L* values was observed among the 3 groups at T1 (P = 0.402), T2 (P = 0.643) and T3 (P = 0.177). Additionally, no significant difference was found in the TS values among the 3 groups at any of the evaluation time points (P for all > 0.05).
CONCLUSIONS


Exposure to coffee or tea during the bleaching treatment period did not affect the effectiveness of the treatment. However, exposure to coffee after the bleaching treatment did affect the effectiveness of the treatment. Exposure to stain-causing beverages did not affect the bleaching-induced TS (ClinicalTrials.gov Identifier: NCT03933527).
CLINICAL SIGNIFICANCE


The consumption of coffee or tea during tooth bleaching may not interfere with the colour change produced by the treatment. However, clinicians should advise their patients to refrain from, at least to some extent, consuming coffee after the bleaching procedure to maintain the effectiveness of the treatment.",2020,"No significant difference in the whiteness index (W), △E,","['tooth bleaching', 'Participants']","['Opalescence BOOST', 'stain-causing beverages', 'hydrogen peroxide']","['numerical rating scale (NRS) and a visual analogue scale (VAS', 'TS values', 'Tooth sensitivity (TS', 'whiteness index (W), △E', '△L* values']","[{'cui': 'C0040431', 'cui_str': 'Tooth Whitening'}]","[{'cui': 'C0296695', 'cui_str': 'tooth-bleaching agent, Opalescence'}, {'cui': 'C0487602', 'cui_str': 'Staining'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0005329', 'cui_str': 'Beverages'}, {'cui': 'C0020281', 'cui_str': 'Hydrogen Peroxide'}]","[{'cui': 'C0222045'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0011432', 'cui_str': 'Tooth Sensitivity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0249774,"No significant difference in the whiteness index (W), △E,","[{'ForeName': 'Ying-Hui', 'Initials': 'YH', 'LastName': 'Chen', 'Affiliation': 'Fujian Key Laboratory of Oral Diseases & Fujian Provincial Engineering Research Center of Oral Biomaterial & Stomatological Key Laboratory of Fujian College and University, School and Hospital of Stomatology, Fujian Medical University, China.'}, {'ForeName': 'Song', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': 'Fujian Key Laboratory of Oral Diseases & Fujian Provincial Engineering Research Center of Oral Biomaterial & Stomatological Key Laboratory of Fujian College and University, School and Hospital of Stomatology, Fujian Medical University, China.'}, {'ForeName': 'Deng-Wei', 'Initials': 'DW', 'LastName': 'Hong', 'Affiliation': 'Fujian Key Laboratory of Oral Diseases & Fujian Provincial Engineering Research Center of Oral Biomaterial & Stomatological Key Laboratory of Fujian College and University, School and Hospital of Stomatology, Fujian Medical University, China.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Attin', 'Affiliation': 'Clinic of Conservative and Preventive Dentistry, Center of Dental Medicine, University Zurich, Zurich, Switzerland.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Yu', 'Affiliation': 'Fujian Key Laboratory of Oral Diseases & Fujian Provincial Engineering Research Center of Oral Biomaterial & Stomatological Key Laboratory of Fujian College and University, School and Hospital of Stomatology, Fujian Medical University, China; Department of Applied Prosthodontics, Graduate School of Biomedical Sciences, Nagasaki University, Japan. Electronic address: haoyu-cn@hotmail.com.'}]",Journal of dentistry,['10.1016/j.jdent.2020.103318']
329,32279690,Resistant starch supplementation increases crypt cell proliferative state in the rectal mucosa of older healthy participants.,"There is strong evidence that foods containing dietary fibre protect against colorectal cancer, resulting at least in part from its anti-proliferative properties. This study aimed to investigate the effects of supplementation with two non-digestible carbohydrates, resistant starch (RS) and polydextrose (PD), on crypt cell proliferative state (CCPS) in the macroscopically normal rectal mucosa of healthy individuals. We also investigated relationships between expression of regulators of apoptosis and of the cell cycle on markers of CCPS. Seventy-five healthy participants were supplemented with RS and/or PD or placebo for 50 d in a 2 × 2 factorial design in a randomised, double-blind, placebo-controlled trial (the Dietary Intervention, Stem cells and Colorectal Cancer (DISC) Study). CCPS was assessed, and the expression of regulators of the cell cycle and of apoptosis was measured by quantitative PCR in rectal mucosal biopsies. SCFA concentrations were quantified in faecal samples collected pre- and post-intervention. Supplementation with RS increased the total number of mitotic cells within the crypt by 60 % (P = 0·001) compared with placebo. This effect was limited to older participants (aged ≥50 years). No other differences were observed for the treatments with PD or RS as compared with their respective controls. PD did not influence any of the measured variables. RS, however, increased cell proliferation in the crypts of the macroscopically-normal rectum of older adults. Our findings suggest that the effects of RS on CCPS are not only dose, type of RS and health status-specific but are also influenced by age.",2020,Supplementation with RS increased the total number of mitotic cells within the crypt by 60% (p=0.001) compared with placebo.,"['75 healthy participants', 'older participants (aged ≥50', 'older healthy participants', 'macroscopically-normal rectal mucosa of healthy individuals']","['RS and/or PD or placebo', 'supplementation with two non-digestible carbohydrates, resistant starch (RS) and polydextrose (PD', 'Resistant starch supplementation', 'placebo']","['expression of regulators of the cell cycle and of apoptosis', 'SCFA concentrations', 'total number of mitotic cells', 'crypt cell proliferative state (CCPS', 'cell proliferation', 'crypt cell proliferative state']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0227395', 'cui_str': 'Rectal mucous membrane structure'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0038179', 'cui_str': 'Starch'}, {'cui': 'C0071545', 'cui_str': 'polydextrose'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}]","[{'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0007634', 'cui_str': 'Cell structure'}, {'cui': 'C0162638', 'cui_str': 'Apoptosis'}, {'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0230518', 'cui_str': 'Mitotic cell'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0334094', 'cui_str': 'Proliferation'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0596290', 'cui_str': 'Cellular Proliferation'}]",75.0,0.290488,Supplementation with RS increased the total number of mitotic cells within the crypt by 60% (p=0.001) compared with placebo.,"[{'ForeName': 'Fiona C', 'Initials': 'FC', 'LastName': 'Malcomson', 'Affiliation': 'Human Nutrition Research Centre, Population Health Sciences Institute, Newcastle University, Newcastle upon TyneNE2 4HH, UK.'}, {'ForeName': 'Naomi D', 'Initials': 'ND', 'LastName': 'Willis', 'Affiliation': 'Human Nutrition Research Centre, Population Health Sciences Institute, Newcastle University, Newcastle upon TyneNE2 4HH, UK.'}, {'ForeName': 'Iain', 'Initials': 'I', 'LastName': 'McCallum', 'Affiliation': 'Northumbria Healthcare NHS Foundation Trust, North ShieldsNE29 8NH, UK.'}, {'ForeName': 'Long', 'Initials': 'L', 'LastName': 'Xie', 'Affiliation': 'Human Nutrition Research Centre, Population Health Sciences Institute, Newcastle University, Newcastle upon TyneNE2 4HH, UK.'}, {'ForeName': 'Arthur C', 'Initials': 'AC', 'LastName': 'Ouwehand', 'Affiliation': 'DuPont Nutrition & Biosciences, 02460Kantvik, Finland.'}, {'ForeName': 'Julian D', 'Initials': 'JD', 'LastName': 'Stowell', 'Affiliation': 'DuPont Nutrition & Biosciences, ReigateRH2 9PQ, UK.'}, {'ForeName': 'Seamus', 'Initials': 'S', 'LastName': 'Kelly', 'Affiliation': 'Northumbria Healthcare NHS Foundation Trust, North ShieldsNE29 8NH, UK.'}, {'ForeName': 'D Michael', 'Initials': 'DM', 'LastName': 'Bradburn', 'Affiliation': 'Northumbria Healthcare NHS Foundation Trust, AshingtonNE63 9JJ, UK.'}, {'ForeName': 'Nigel J', 'Initials': 'NJ', 'LastName': 'Belshaw', 'Affiliation': 'University of East Anglia, Norwich Research Park, NorwichNR4 7TJ, UK.'}, {'ForeName': 'Ian T', 'Initials': 'IT', 'LastName': 'Johnson', 'Affiliation': 'Quadram Institute, Norwich Research Park, NorwichNR4 7UQ, UK.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Mathers', 'Affiliation': 'Human Nutrition Research Centre, Population Health Sciences Institute, Newcastle University, Newcastle upon TyneNE2 4HH, UK.'}]",The British journal of nutrition,['10.1017/S0007114520001312']
330,32105522,The effect of blood flow restriction exercise on exercise-induced hypoalgesia and endogenous opioid and endocannabinoid mechanisms of pain modulation.,"This study aimed to investigate and compare the magnitude of exercise-induced hypoalgesia (EIH) with low-intensity blood flow restriction (BFR) resistance exercise (RE) at varying pressures to other intensities of resistance exercise and examine endogenous mechanisms of pain reduction. Twelve individuals performed four experimental trials involving unilateral leg press exercise in a randomized crossover design: low-load RE at 30% of one repetition maximum (1RM), high-load RE (70% 1RM), and BFR-RE (30% 1RM) at a low and high pressure. BFR pressure was prescribed relative to limb occlusion pressure at 40% and 80% for the low- and high-pressure trials. Pressure pain thresholds (PPT) were assessed before and 5 min and 24 h following exercise in exercising and nonexercising muscles. Venous blood samples were collected at the same timepoints to determine plasma concentrations of beta-endorphin and 2-arachidonoylglycerol. High-pressure BFR-RE increased PPTs in the exercising limb to a greater extent than all other trials. Comparable systemic EIH effects were observed with HLRE and both BFR-RE trials. PPTs in the exercising limb remained elevated above baseline at 24 h postexercise following both BFR-RE trials. Postexercise plasma beta-endorphin concentration was elevated during the BFR-RE trials. No changes to 2-arachidonoylglycerol concentration were observed. High pressure BFR-RE causes a greater EIH response in the exercising limb that persists for up to 24 h following exercise. The reduction in pain sensitivity with BFR-RE is partly driven by endogenous opioid production of beta-endorphin. BFR-RE should be investigated as a possible pain-modulation tool in individuals with acute and chronic pain. NEW & NOTEWORTHY  High-pressure blood flow restriction (BFR) causes a greater hypoalgesia response in the exercising limb (48%) compared with light and heavy load resistance exercise (10-34%). Performing light load resistance exercise with BFR causes systemic hypoalgesia comparable with heavy load resistance exercise (10-18%). BFR resistance exercise prolonged the exercise-induced hypoalgesia response for 24 h in the exercising limb (15% and 24%, respectively). Activation of endogenous opioid production and a conditioned pain modulation effect partly mediate the relationship between exercise and hypoalgesia.",2020,The reduction in pain sensitivity with BFR-RE is partly driven by endogenous opioid production of beta-endorphin.,"['individuals with acute and chronic pain', 'pain modulation']","['blood flow restriction exercise', 'exercise-induced hypoalgesia (EIH) with low intensity blood flow restriction (BFR) resistance exercise (RE', 'unilateral leg press exercise']","['Post-exercise plasma beta-endorphin concentration', 'Pressure pain thresholds (PPT', 'limb occlusion pressure', 'High pressure BFR-RE increased PPTs', 'pain sensitivity', 'systemic EIH effects', '2-arachidonoylglycerol concentration', 'EIH response', 'BFR pressure', 'Venous blood samples']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0085625', 'cui_str': 'Hypoalgesia (finding)'}, {'cui': 'C0596836', 'cui_str': 'Low intensity'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}]","[{'cui': 'C1979962', 'cui_str': 'After exercise (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0005210', 'cui_str': 'beta-Endorphin (1-31)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0162703', 'cui_str': 'Pain Threshold'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0299477', 'cui_str': '5,8,11,14-Eicosatetraenoic acid, 2-hydroxy-1-(hydroxymethyl)ethyl ester, (5Z,8Z,11Z,14Z)-'}, {'cui': 'C0444255', 'cui_str': 'Venous blood specimen'}]",,0.187457,The reduction in pain sensitivity with BFR-RE is partly driven by endogenous opioid production of beta-endorphin.,"[{'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Hughes', 'Affiliation': ""Faculty of Sport, Health and Applied Science, St Mary's University, London, United Kingdom.""}, {'ForeName': 'Stephen David', 'Initials': 'SD', 'LastName': 'Patterson', 'Affiliation': ""Faculty of Sport, Health and Applied Science, St Mary's University, London, United Kingdom.""}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00768.2019']
331,32282520,A Randomized Controlled Trial Comparing Flat Times Versus Standard Care in Pediatric Patients Post Cardiac Catheterization.,"BACKGROUND


Pediatric patients undergoing cardiac catheterization procedures are required to lie flat for 4 hours for femoral venous access and 6 hours for femoral arterial access. Authors of research in adults suggest the flat time for the same access can be safely reduced to 1.5 to 2 hours post procedure. No literature was found that flat times could be safely reduced for pediatric patients.
OBJECTIVE


The purpose of this study was to determine whether decreased flat time for the post-cardiac catheterization pediatric patient would impact the incidence of site bleeding, additional sedation, and the need for a critical care admission.
METHODS


A randomized controlled trial was designed and participants were randomly assigned to experimental or control group. The experimental group reduced flat times to 2 hours for venous and 4 hours for arterial. The control group was standard care of 4 hours for venous and 6 hours for arterial.
RESULTS


A total of 119 participants were enrolled, 60 in the experimental group and 59 in the control group. Results suggest no difference in the incidence of site bleeding (P = .999), additional sedation (P = .653), or need for a critical care admission.
CONCLUSIONS


For pediatric patients undergoing arterial or venous cardiac catheterizations, flat times can safely be reduced without increasing site bleeding, additional sedation, or critical care admissions.",2020,"Results suggest no difference in the incidence of site bleeding (P = .999), additional sedation (P = .653), or need for a critical care admission.
","['A total of 119 participants were enrolled, 60 in the experimental group and 59 in the control group', 'pediatric patients undergoing arterial or venous cardiac catheterizations', 'Pediatric patients undergoing cardiac catheterization procedures', 'Pediatric Patients Post Cardiac Catheterization']",['Flat Times Versus Standard Care'],"['additional sedation', 'incidence of site bleeding']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0018795', 'cui_str': 'Cardiac catheterization'}, {'cui': 'C0687676', 'cui_str': 'After values'}]","[{'cui': 'C0205324', 'cui_str': 'Flat'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C2945843', 'cui_str': 'Site of'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",119.0,0.113565,"Results suggest no difference in the incidence of site bleeding (P = .999), additional sedation (P = .653), or need for a critical care admission.
","[{'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Raic', 'Affiliation': ""Rebecca Raic, MSN, RN, CPNP-PCI Nurse Practitioner, Cardiac Catheterization Laboratory, St. Louis Children's Hospital, Missouri. Lisa M. Steurer, PhD, RN, CPNP-PC Manager, Research & Outcomes, St. Louis Children's Hospital, Missouri. Karen Balakas, PhD, RN Manager, Research & Outcomes (retired), St. Louis Children's Hospital, Missouri. Patrick M. Ercole, PhD, MPH Senior Statistician, Sansom Consulting, San Antonio, Texas.""}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Steurer', 'Affiliation': ''}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Balakas', 'Affiliation': ''}, {'ForeName': 'Patrick M', 'Initials': 'PM', 'LastName': 'Ercole', 'Affiliation': ''}]",The Journal of cardiovascular nursing,['10.1097/JCN.0000000000000677']
332,32286620,Early Child Development Outcomes of a Randomized Trial Providing 1 Egg Per Day to Children Age 6 to 15 Months in Malawi.,"BACKGROUND


Eggs are a rich source of nutrients important for brain development, including choline, riboflavin, vitamins B-6 and B-12, folate, zinc, protein, and DHA.
OBJECTIVE


Our objective was to evaluate the effect of the consumption of 1 egg per day over a 6-mo period on child development.
METHODS


In the Mazira Project randomized controlled trial, 660 children aged 6-9 mo were randomly allocated into an intervention or control group. Eggs were provided to intervention households during twice-weekly home visits for 6 mo. Control households were visited at the same frequency. At enrollment, blinded assessors administered the Malawi Developmental Assessment Tool (MDAT), and 2 eye-tracking tasks using a Tobii-Pro X2-60 eye tracker: a visual paired comparison memory task and an Infant Orienting with Attention task. At endline, 6-mo later, blinded assessors administered the MDAT and eye-tracking tasks plus an additional elicited imitation memory task.
RESULTS


At endline, intervention and control groups did not significantly differ in any developmental score, with the exception that a smaller percentage of children were delayed in fine motor development in the intervention group (10.6%) compared with the control group (16.5%; prevalence ratio: 0.59, 95% CI: 0.38-0.91). Among 10 prespecified effect modifiers for the 8 primary developmental outcomes, we found 7 significant interactions demonstrating a consistent pattern that children who were less vulnerable, for example, those with higher household wealth and maternal education, showed positive effects of the intervention. Given multiple hypothesis testing, some findings may have been due to chance.
CONCLUSION


The provision of 1 egg per day had no overall effect on child development in this population of children, however, some benefits may be seen among children in less vulnerable circumstances. This trial was registered at clinicaltrials.gov as NCT03385252.",2020,"At endline, intervention and control groups did not significantly differ in any developmental score, with the exception that a smaller percentage of children were delayed in fine motor development in the intervention group (10.6%) compared with the control group (16.5%; prevalence ratio: 0.59, 95% CI: 0.38-0.91).",['660 children aged 6-9 mo'],"['Malawi Developmental Assessment Tool (MDAT), and 2 eye-tracking tasks using a Tobii-Pro X2-60 eye tracker: a visual paired comparison memory task and an Infant Orienting with Attention task']","['developmental score', 'fine motor development']","[{'cui': 'C4517845', 'cui_str': '660'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0442751', 'cui_str': 'Distance vision 6/9'}]","[{'cui': 'C0024548', 'cui_str': 'Malawi'}, {'cui': 'C0458003', 'cui_str': 'Developmental'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0086766', 'cui_str': 'Paired Comparisons'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]","[{'cui': 'C0458003', 'cui_str': 'Developmental'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205232', 'cui_str': 'Fine'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}]",660.0,0.253052,"At endline, intervention and control groups did not significantly differ in any developmental score, with the exception that a smaller percentage of children were delayed in fine motor development in the intervention group (10.6%) compared with the control group (16.5%; prevalence ratio: 0.59, 95% CI: 0.38-0.91).","[{'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Prado', 'Affiliation': 'Department of Nutrition and Institute for Global Nutrition, University of California Davis, Davis, CA, USA.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Maleta', 'Affiliation': 'School of Public Health and Family Medicine, University of Malawi College of Medicine, Blantyre, Malawi.'}, {'ForeName': 'Bess L', 'Initials': 'BL', 'LastName': 'Caswell', 'Affiliation': 'Department of Nutrition and Institute for Global Nutrition, University of California Davis, Davis, CA, USA.'}, {'ForeName': 'Matthews', 'Initials': 'M', 'LastName': 'George', 'Affiliation': 'School of Public Health and Family Medicine, University of Malawi College of Medicine, Blantyre, Malawi.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Oakes', 'Affiliation': 'Department of Psychology and Center for Mind and Brain, University of California Davis, Davis, CA, USA.'}, {'ForeName': 'Michaela C', 'Initials': 'MC', 'LastName': 'DeBolt', 'Affiliation': 'Department of Psychology and Center for Mind and Brain, University of California Davis, Davis, CA, USA.'}, {'ForeName': 'Megan G', 'Initials': 'MG', 'LastName': 'Bragg', 'Affiliation': 'Department of Nutrition and Institute for Global Nutrition, University of California Davis, Davis, CA, USA.'}, {'ForeName': 'Charles D', 'Initials': 'CD', 'LastName': 'Arnold', 'Affiliation': 'Department of Nutrition and Institute for Global Nutrition, University of California Davis, Davis, CA, USA.'}, {'ForeName': 'Lora L', 'Initials': 'LL', 'LastName': 'Iannotti', 'Affiliation': 'Brown School, Institute for Public Health, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Chessa K', 'Initials': 'CK', 'LastName': 'Lutter', 'Affiliation': 'RTI International, Washington DC, School of Public Health, University of Maryland, College Park, MD, USA.'}, {'ForeName': 'Christine P', 'Initials': 'CP', 'LastName': 'Stewart', 'Affiliation': 'Department of Nutrition and Institute for Global Nutrition, University of California Davis, Davis, CA, USA.'}]",The Journal of nutrition,['10.1093/jn/nxaa088']
333,31365441,Factors Influencing Cardiovascular Risk Factors and Health Perception Among Kentuckians Living in Appalachia.,"BACKGROUND


Cardiovascular disease (CVD) and risk factors for CVD are prevalent among Appalachians from Kentucky. Appalachian men and women have high rates of engagement in unhealthy behaviors and poor physical health measures that increase their risk for CVD.
OBJECTIVE


In this study, the relationship among gender, CVD risk factors, and health perception in Appalachians from Kentucky was explored.
METHODS


This cross-sectional secondary analysis is from a randomized controlled trial on CVD health in rural Kentucky. To assess gender differences in smoking history, χ was used. Independent t tests compared the mean between participants 50 years or younger and those older than 50 years with differences in body mass index (BMI), waist circumference, systolic and diastolic blood pressure, hemoglobin A1C, total cholesterol, and physical activity. A multivariate linear regression analysis assessed variables predicting the outcome of health perception.
RESULTS


Most participants had a mean BMI of 33 kg/m and 94.3% of men used smokeless tobacco compared to 5.7% of the women. Differences existed between gender and current, ever, or never smoked (P < .001). Women had higher total cholesterol levels but men had higher waist circumference. Participants older than 50 years had higher engagement in physical activity than did those 50 years or younger. Higher BMI and hemoglobin A1C level were significant predictors of worse health perception (P ≤ .05). For every unit increase in the physical activity scale, there was a 0.2-unit improvement in health perception (P ≤ .001).
CONCLUSION


Appalachians from Kentucky have many CVD risk factors. Minimal engagement in preventative measures against CVD can worsen patient outcomes.",2020,"For every unit increase in the physical activity scale, there was a 0.2-unit improvement in health perception (P ≤ .001).
","['CVD health in rural Kentucky', 'Participants older than 50 years had higher engagement in physical activity than did those 50 years or younger', 'Kentuckians Living in Appalachia', 'Appalachian men and women']",[],"['total cholesterol levels', 'health perception', 'Higher BMI and hemoglobin A1C level', 'mean BMI', 'smokeless tobacco', 'physical activity scale', 'body mass index (BMI), waist circumference, systolic and diastolic blood pressure, hemoglobin A1C, total cholesterol, and physical activity', 'Cardiovascular Risk Factors and Health Perception']","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0022557', 'cui_str': 'Kentucky'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0003609', 'cui_str': 'Appalachia'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]",[],"[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0428466', 'cui_str': 'Finding of cholesterol level (finding)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0040338', 'cui_str': 'Smokeless Tobacco'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0222045'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]",,0.0624386,"For every unit increase in the physical activity scale, there was a 0.2-unit improvement in health perception (P ≤ .001).
","[{'ForeName': 'Cilgy M', 'Initials': 'CM', 'LastName': 'Abraham', 'Affiliation': 'Cilgy M. Abraham, BS, RN PhD Candidate, School of Nursing, Columbia University, New York, New York. Sarah Kelly, PhD, RN Associate Professor, School of Nursing, Montclair State University, New Jersey. Dean Wantland, PhD, RN Adjunct Professor, School of Nursing, Montclair State University, New Jersey. Misook L. Chung, PhD, RN, FAAN, FAHA Professor, College of Nursing, University of Kentucky, Lexington. Gia Mudd-Martin, PhD, MPH, RN, FAHA Associate Professor, College of Nursing, University of Kentucky, Lexington. Martha J. Biddle, PhD, RN, APRN, CCNS, FAHA Associate Professor, College of Nursing, University of Kentucky, Lexington. Debra K. Moser, PhD, RN, FAAN, FAHA Professor and Linda C. Gill Endowed Chair of Nursing, College of Nursing, University of Kentucky, Lexington.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Kelly', 'Affiliation': ''}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Wantland', 'Affiliation': ''}, {'ForeName': 'Misook L', 'Initials': 'ML', 'LastName': 'Chung', 'Affiliation': ''}, {'ForeName': 'Gia', 'Initials': 'G', 'LastName': 'Mudd-Martin', 'Affiliation': ''}, {'ForeName': 'Martha J', 'Initials': 'MJ', 'LastName': 'Biddle', 'Affiliation': ''}, {'ForeName': 'Debra K', 'Initials': 'DK', 'LastName': 'Moser', 'Affiliation': ''}]",The Journal of cardiovascular nursing,['10.1097/JCN.0000000000000594']
334,32199790,Pregnancy intentions and contraceptive uptake after miscarriage.,"OBJECTIVE


To identify factors associated with contraceptive uptake among participants in a miscarriage management clinical trial.
STUDY DESIGN


We performed a secondary analysis of a multi-center, randomized controlled trial of medical management regimens for miscarriage between 5 and 12 completed weeks. Pregnancy intention was measured by patient report after miscarriage diagnosis. Participants were offered contraception in accordance with standard clinical care once their miscarriage was completed. We analyzed participants as a cohort and fit a multivariable model to describe demographic characteristics and pregnancy intentions independently associated with contraceptive uptake.
RESULTS


Of 244 participants with available contraceptive outcomes, 121 (50%) stated that this pregnancy was planned, and 218 (90%) stated that they had planned to continue the pregnancy to term. Ninety-seven participants (40%) initiated contraception: 33 (14%) selected a long-acting reversible method, 44 (18%) a short-acting reversible method, and 20 (8%) condoms or emergency contraception, while 147 (60%) declined contraception after miscarriage completion. In the multivariable model, unplanned pregnancy (aRR 2.13, 95% CI: 1.45-3.13) and lack of intention to continue the pregnancy (aRR 1.61, 95% CI: 1.18-2.20) were independently associated with contraceptive uptake. Of participants who declined contraception, 85 (57%) did so in order to conceive again. Nearly one-quarter of participants who declined contraception described the index pregnancy as unplanned, but after miscarriage planned to conceive a new pregnancy.
CONCLUSION


Patients with unplanned pregnancy who miscarried were twice as likely to initiate contraception as those with planned pregnancy, however pregnancy intentions sometimes changed after miscarriage.
IMPLICATIONS


Miscarriage management represents an important opportunity to clarify pregnancy goals and provide contraceptive counseling. Although unplanned pregnancy correlates with contraceptive uptake, we do not recommend using this clinically to predict contraceptive need. Future research should examine how best to measure pregnancy intention and its relationship to the experience of miscarriage.",2020,"In the multivariable model, unplanned pregnancy (aRR 2.13, 95% CI: 1.45-3.13) and lack of intention to continue the pregnancy (aRR 1.61, 95% CI: 1.18-2.20) were independently associated with contraceptive uptake.","['244 participants with available contraceptive outcomes, 121 (50', 'Ninety-seven participants (40%) initiated contraception: 33 (14%) selected a long-acting reversible method, 44 (18%) a short-acting reversible method, and 20 (8%) condoms or emergency contraception, while 147 (60%) declined contraception after miscarriage completion', 'participants in a miscarriage management clinical trial', 'Of participants who declined contraception, 85 (57%) did so in order to conceive again', 'miscarriage between 5 and 12 completed weeks']",[],"['Pregnancy intention', 'unplanned pregnancy', 'Pregnancy intentions and contraceptive uptake']","[{'cui': 'C4517660', 'cui_str': 'Two hundred and forty-four'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0009871', 'cui_str': 'Contraceptives'}, {'cui': 'C0439073', 'cui_str': '97 (qualifier value)'}, {'cui': 'C0700589', 'cui_str': 'Fertility Control'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0205343', 'cui_str': 'Reversible (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0009653', 'cui_str': 'Condoms'}, {'cui': 'C0558252', 'cui_str': 'Emergency Contraception'}, {'cui': 'C0000786', 'cui_str': 'Vaginal expulsion of product of conception'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]",[],"[{'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0041747', 'cui_str': 'Unintended Pregnancy'}, {'cui': 'C0009871', 'cui_str': 'Contraceptives'}]",244.0,0.114047,"In the multivariable model, unplanned pregnancy (aRR 2.13, 95% CI: 1.45-3.13) and lack of intention to continue the pregnancy (aRR 1.61, 95% CI: 1.18-2.20) were independently associated with contraceptive uptake.","[{'ForeName': 'Andrea H', 'Initials': 'AH', 'LastName': 'Roe', 'Affiliation': 'Department of Obstetrics and Gynecology, Perelman School of Medicine, University of Pennsylvania, 3400 Spruce St., Philadelphia, PA 19104, United States. Electronic address: andrea.roe@uphs.upenn.edu.'}, {'ForeName': 'Arden', 'Initials': 'A', 'LastName': 'McAllister', 'Affiliation': 'Department of Obstetrics and Gynecology, Perelman School of Medicine, University of Pennsylvania, 3400 Spruce St., Philadelphia, PA 19104, United States.'}, {'ForeName': 'Mary D', 'Initials': 'MD', 'LastName': 'Sammel', 'Affiliation': 'Department of Biostatistics and Informatics, Colorado School of Public Health, University of Colorado, 13001 E. 17th Place, B119, Bldg 500, 3rd Floor West Wing, Aurora, CO 80045, United States.'}, {'ForeName': 'Courtney A', 'Initials': 'CA', 'LastName': 'Schreiber', 'Affiliation': 'Department of Obstetrics and Gynecology, Perelman School of Medicine, University of Pennsylvania, 3400 Spruce St., Philadelphia, PA 19104, United States.'}]",Contraception,['10.1016/j.contraception.2020.03.002']
335,31005547,Thermoregulatory and perceptual responses of lean and obese fit and unfit girls exercising in the heat.,"OBJECTIVE


To verify the thermoregulatory and perceptual responses of obese and lean girls, either fit or unfit, exercising in the heat at a similar rate of metabolic heat production per unit body mass.
METHODS


A total of 34 pubescent girls were allocated in four groups: 12 obese fit, 9 obese unfit, 5 lean fit, and 8 lean unfit. The obese groups (13.2±1.4 years, 40.5%±5.8% fat by DXA) differed in their aerobic fitness (V˙O 2peak  76.0±8.1 vs. 56.6±5.8mL.kgmusclemass -1 .min -1 ), as well as the lean groups (13.1±1.6 years, 24.0%±4.8% fat) (V˙O 2peak  74.5±2.9 vs. 56.2±5.0mL.kgmuscle mass -1 min -1 ). Girls cycled two bouts of 25min with a 10min rest in between, at ∼5.4W.kg -1  in the heat (36°C and 40% relative humidity) and they were kept euhydrated. Rectal and skin temperatures and heart rate were measured every 5min. Perceptual responses were evaluated throughout the exercise.
RESULTS


Initial rectal temperature was higher in the obese subjects compared to the lean subjects (37.5±0.3 and 37.2±0.3°C). No difference was observed among the girls whom were obese (eight fit or unfit) and lean (also fit or unfit) throughout the exercise in rectal temperature (37.6±0.2, 37.5±0.3, 37.5±0.3, 37.4±0.3°C, respectively), skin temperature (34.8±0.8, 35.1±1.0, 34.4±0.9, 35.2±0.9°C), and heart rate (128±18; 118±12, 130±16, 119±16beatsmin -1 ). No differences were observed in perceptual responses among groups.
CONCLUSION


Regardless of the adiposity or aerobic fitness, pubescent girls had similar thermoregulatory and perceptual responses while cycling in the heat at similar metabolic heat production.",2020,"RESULTS


Initial rectal temperature was higher in the obese subjects compared to the lean subjects (37.5±0.3 and 37.2±0.3°C).","['obese and lean girls', 'lean and obese fit and unfit girls exercising in the heat', '34 pubescent girls were allocated in four groups: 12 obese fit, 9 obese unfit, 5 lean fit, and 8 lean unfit']",[],"['perceptual responses', 'Initial rectal temperature', 'Rectal and skin temperatures and heart rate', 'skin temperature', 'aerobic fitness', 'Perceptual responses']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]",[],"[{'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0489749', 'cui_str': 'Rectal temperature'}, {'cui': 'C0205052', 'cui_str': 'Rectal (qualifier value)'}, {'cui': 'C0037294', 'cui_str': 'Skin Temperature'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}]",34.0,0.0301948,"RESULTS


Initial rectal temperature was higher in the obese subjects compared to the lean subjects (37.5±0.3 and 37.2±0.3°C).","[{'ForeName': 'Carolina de Ávila', 'Initials': 'CÁ', 'LastName': 'Rodrigues', 'Affiliation': 'Universidade Federal do Rio Grande do Sul (UFRGS), Escola de Educação Física, Fisioterapia e Dança, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Gabriela Tomedi', 'Initials': 'GT', 'LastName': 'Leites', 'Affiliation': 'Universidade Federal do Rio Grande do Sul (UFRGS), Escola de Educação Física, Fisioterapia e Dança, Porto Alegre, RS, Brazil. Electronic address: gabitomedi@yahoo.com.br.'}, {'ForeName': 'Flavia', 'Initials': 'F', 'LastName': 'Meyer', 'Affiliation': 'Universidade Federal do Rio Grande do Sul (UFRGS), Escola de Educação Física, Fisioterapia e Dança, Porto Alegre, RS, Brazil.'}]",Jornal de pediatria,['10.1016/j.jped.2018.12.011']
336,32151708,Changes in serum estrogenic activity during neoadjuvant therapy with letrozole and exemestane.,"The aromatase inhibitors (AIs), letrozole (Femar®/Femara®) and exemestane (Aromasin®), are widely used to treat estrogen receptor (ER) positive breast cancer in postmenopausal patients. In the setting of metastatic breast cancer, these drugs may be used after another causing new responses in selected patients after progressing on the first choice. The precise explanation for this ""lack of cross resistance"" is still missing. NEOLETEXE is a neoadjuvant, randomized, open-label, cross-over trial. Postmenopausal patients with ER-positive, HER-2 negative, locally advanced breast cancer were enrolled. All patients were randomized to treatment starting with either letrozole or exemestane for at least 2 months followed by another 2 months on the alternative AI. The total estrogenic activities in blood samples were determined using the AroER tri-screen assay developed in the Chen laboratory. Using this highly sensitive assay, estrogenic activity was detected at three time points for all patients. Importantly, a significantly higher total estrogenic activity was found during therapy with exemestane compared to letrozole in 21 out of 26 patients. When letrozole was included in the AroER tri-screen assay, the estrogenic activities in most samples collected during exemestane treatment were further reduced, suggesting that low levels of androgens remained in specimens obtained after exemestane treatment. Our results suggest the AroER tri-screen to be a very sensitive method to estimate the overall estrogen-mediated activity in human samples even during therapy with highly potent aromatase inhibitors. In the present study, serum estrogen activity was significantly higher during exemestane therapy when compared to letrozole therapy.",2020,"In the present study, serum estrogen activity was significantly higher during exemestane therapy when compared to letrozole therapy.","['postmenopausal patients', 'Postmenopausal patients with ER-positive, HER-2 negative, locally advanced breast cancer were enrolled']","['letrozole', 'letrozole and exemestane', 'aromatase inhibitors (AIs), letrozole (Femar®/Femara®) and exemestane (Aromasin®', 'letrozole or exemestane', 'exemestane']","['total estrogenic activities in blood samples', 'serum estrogenic activity', 'estrogenic activity', 'serum estrogen activity', 'total estrogenic activity', 'estrogenic activities']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C3495949', 'cui_str': 'Locally advanced breast cancer'}]","[{'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C0851344', 'cui_str': 'exemestane'}, {'cui': 'C0593802', 'cui_str': 'Aromatase Inhibitors'}, {'cui': 'C0876723', 'cui_str': 'Aromasin'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0857965', 'cui_str': 'Serum oestrogen'}]",26.0,0.0127101,"In the present study, serum estrogen activity was significantly higher during exemestane therapy when compared to letrozole therapy.","[{'ForeName': 'Nazli', 'Initials': 'N', 'LastName': 'Bahrami', 'Affiliation': 'Department of Oncology, Akershus University Hospital (AHUS), Lørenskog, Norway; Department of Breast and Endocrine Surgery, Akershus University Hospital, Lørenskog, Norway.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Chang', 'Affiliation': 'Department of Cancer Biology, Beckman Research Institute of the City of Hope, Duarte, CA, USA.'}, {'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Kanaya', 'Affiliation': 'Department of Cancer Biology, Beckman Research Institute of the City of Hope, Duarte, CA, USA.'}, {'ForeName': 'Torill', 'Initials': 'T', 'LastName': 'Sauer', 'Affiliation': 'Department of Pathology, Akershus University Hospital, Lørenskog, Norway; Institute of Clinical Medicine, University of Oslo, Campus AHUS, Norway.'}, {'ForeName': 'Daehoon', 'Initials': 'D', 'LastName': 'Park', 'Affiliation': 'Department of Pathology, Akershus University Hospital, Lørenskog, Norway.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Loeng', 'Affiliation': 'Department of Oncology, Akershus University Hospital (AHUS), Lørenskog, Norway.'}, {'ForeName': 'Berit', 'Initials': 'B', 'LastName': 'Gravdehaug', 'Affiliation': 'Department of Breast and Endocrine Surgery, Akershus University Hospital, Lørenskog, Norway.'}, {'ForeName': 'Shiuan', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Department of Cancer Biology, Beckman Research Institute of the City of Hope, Duarte, CA, USA.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Geisler', 'Affiliation': 'Department of Oncology, Akershus University Hospital (AHUS), Lørenskog, Norway; Institute of Clinical Medicine, University of Oslo, Campus AHUS, Norway. Electronic address: juergen.geisler@medisin.uio.no.'}]",The Journal of steroid biochemistry and molecular biology,['10.1016/j.jsbmb.2020.105641']
337,31937915,High-intensity interval training for reducing blood pressure: a randomized trial vs. moderate-intensity continuous training in males with overweight or obesity.,"The optimal exercise-training characteristics for reducing blood pressure (BP) are unclear. We investigated the effects of 6-weeks of high-intensity interval training (HIIT) or moderate-intensity continuous training (MICT) on BP and aortic stiffness in males with overweight or obesity. Twenty-eight participants (18-45 years; BMI: 25-35 kg/m 2 ) performed stationary cycling three times per week for 6 weeks. Participants were randomly allocated (unblinded) to work-matched HIIT (N = 16; 10 × 1-min intervals at 90-100% peak workload) or MICT (N = 12; 30 min at 65-75% peak heart rate). Central (aortic) and peripheral (brachial) BP and aortic stiffness was assessed before and after training. There were no significant group × time interactions for any BP measure (all p > 0.21). HIIT induced moderate reductions in central (systolic/diastolic ∆: -4.6/-3.5 mmHg, effect size d = -0.51/-0.40) and peripheral BP (-5.2/-4 mmHg, d = -0.45/-0.47). MICT induced moderate reductions in diastolic BP only (peripheral: -3.4 mmHg, d = -0.57; central: -3 mmHg, d = -0.50). The magnitude of improvement in BP was strongly negatively correlated with baseline BP (r = -0.66 to -0.78), with stronger correlations observed for HIIT (r = -0.73 to -0.88) compared with MICT (r = -0.43 to -0.61). HIIT was effective for reducing BP (~3-5 mmHg) in the overweight to obese cohort. Exercise training induced positive changes in central (aortic) BP. The BP-lowering effects of exercise training are more prominent in those with higher baseline BP, with stronger correlation in HIIT than MICT.",2020,HIIT induced moderate reductions in central (systolic/diastolic ∆: -4.6/-3.5 ,['males with overweight or obesity'],"['High-intensity interval training', 'MICT', 'moderate-intensity continuous training', 'exercise training', 'Exercise training', 'high-intensity interval training (HIIT) or moderate-intensity continuous training (MICT']","['BP measure', 'Central (aortic) and peripheral (brachial) BP and aortic stiffness', 'BP', 'positive changes in central (aortic) BP', 'diastolic BP', 'blood pressure (BP', 'baseline BP', 'BP and aortic stiffness', 'blood pressure', 'peripheral BP']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C4277545', 'cui_str': 'High-Intensity Intermittent Exercise'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C3178782', 'cui_str': 'Aortic Stiffness'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}]",28.0,0.0346192,HIIT induced moderate reductions in central (systolic/diastolic ∆: -4.6/-3.5 ,"[{'ForeName': 'Tomasin', 'Initials': 'T', 'LastName': 'Clark', 'Affiliation': 'School of Medical Sciences, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Morey', 'Affiliation': 'School of Medical Sciences, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Jones', 'Affiliation': 'School of Medical Sciences, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Marcos', 'Affiliation': 'School of Medical Sciences, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Ristov', 'Affiliation': 'School of Medical Sciences, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Ram', 'Affiliation': 'School of Medical Sciences, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Hakansson', 'Affiliation': 'School of Medical Sciences, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Aysha', 'Initials': 'A', 'LastName': 'Franklin', 'Affiliation': 'School of Medical Sciences, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'McCarthy', 'Affiliation': 'School of Medical Sciences, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Leal', 'Initials': 'L', 'LastName': 'De Carli', 'Affiliation': 'School of Medical Sciences, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Ward', 'Affiliation': 'School of Medical Sciences, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Keech', 'Affiliation': 'School of Medical Sciences, University of New South Wales, Sydney, NSW, Australia. andrew.keech@unsw.edu.au.'}]",Hypertension research : official journal of the Japanese Society of Hypertension,['10.1038/s41440-019-0392-6']
338,31285490,Association between Copy Number Variation and Response to Social Skills Training in Autism Spectrum Disorder.,"Challenges in social communication and interaction are core features of autism spectrum disorder (ASD) for which social skills group training (SSGT) is a commonly used intervention. SSGT has shown modest and heterogeneous effects. One of the major genetic risk factors in ASD is rare copy number variation (CNV). However, limited information exists whether CNV profiles could be used to aid intervention decisions. Here, we analyzed the rare genic CNV carrier status for 207 children, of which 105 received SSGT and 102 standard care as part of a randomized clinical trial for SSGT. We found that being a carrier of rare genic CNV did not have an impact on the SSGT outcome measured by the parent-report Social Responsiveness Scale (SRS). However, when stratifying by pathogenicity and size of the CNVs, we identified that carriers of clinically significant and large genic CNVs (>500 kb) showed inferior SRS outcomes at post-intervention (P = 0.047 and P = 0.036, respectively) and follow-up (P = 0.008 and P = 0.072, respectively) when adjusting for standard care effects. Our study provides preliminary evidence that carriers of clinically significant and large genic CNVs might not benefit as much from SSGT as non-carriers. Our results indicate that genetic information might help guide the modifications of interventions in ASD.",2019,We found that being a carrier of rare genic CNV did not have an impact on the SSGT outcome measured by the parent-report Social Responsiveness Scale (SRS).,"['207 children, of which 105 received SSGT and 102 standard care as part of a randomized clinical trial for SSGT', 'Autism Spectrum Disorder']","['SSGT', 'Social Skills Training']","['Social Responsiveness Scale (SRS', 'inferior SRS outcomes', 'large genic CNVs']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C4521834', 'cui_str': 'United States Military enlisted E6'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}]","[{'cui': 'C4521834', 'cui_str': 'United States Military enlisted E6'}, {'cui': 'C0150777', 'cui_str': 'Social skills training (procedure)'}]","[{'cui': 'C0222045'}, {'cui': 'C0542339', 'cui_str': 'Below (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}]",207.0,0.041929,We found that being a carrier of rare genic CNV did not have an impact on the SSGT outcome measured by the parent-report Social Responsiveness Scale (SRS).,"[{'ForeName': 'Kristiina', 'Initials': 'K', 'LastName': 'Tammimies', 'Affiliation': ""Center of Neurodevelopmental Disorders (KIND), Division of Neuropsychiatry, Centre for Psychiatry Research, Department of Women's and Children's Health, Karolinska Institutet, Solna, Sweden. kristiina.tammimies@ki.se.""}, {'ForeName': 'Danyang', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': ""Center of Neurodevelopmental Disorders (KIND), Division of Neuropsychiatry, Centre for Psychiatry Research, Department of Women's and Children's Health, Karolinska Institutet, Solna, Sweden.""}, {'ForeName': 'Ielyzaveta', 'Initials': 'I', 'LastName': 'Rabkina', 'Affiliation': ""Center of Neurodevelopmental Disorders (KIND), Division of Neuropsychiatry, Centre for Psychiatry Research, Department of Women's and Children's Health, Karolinska Institutet, Solna, Sweden.""}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Stamouli', 'Affiliation': ""Center of Neurodevelopmental Disorders (KIND), Division of Neuropsychiatry, Centre for Psychiatry Research, Department of Women's and Children's Health, Karolinska Institutet, Solna, Sweden.""}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Becker', 'Affiliation': ""Center of Neurodevelopmental Disorders (KIND), Division of Neuropsychiatry, Centre for Psychiatry Research, Department of Women's and Children's Health, Karolinska Institutet, Solna, Sweden.""}, {'ForeName': 'Veronika', 'Initials': 'V', 'LastName': 'Nicolaou', 'Affiliation': ""Center of Neurodevelopmental Disorders (KIND), Division of Neuropsychiatry, Centre for Psychiatry Research, Department of Women's and Children's Health, Karolinska Institutet, Solna, Sweden.""}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Berggren', 'Affiliation': ""Center of Neurodevelopmental Disorders (KIND), Division of Neuropsychiatry, Centre for Psychiatry Research, Department of Women's and Children's Health, Karolinska Institutet, Solna, Sweden.""}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Coco', 'Affiliation': ""Center of Neurodevelopmental Disorders (KIND), Division of Neuropsychiatry, Centre for Psychiatry Research, Department of Women's and Children's Health, Karolinska Institutet, Solna, Sweden.""}, {'ForeName': 'Torbjörn', 'Initials': 'T', 'LastName': 'Falkmer', 'Affiliation': 'Curtin Autism Research Group, School of Occupational Therapy, Social Work and Speech Pathology, Curtin University, Bentley, Australia.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Jonsson', 'Affiliation': ""Center of Neurodevelopmental Disorders (KIND), Division of Neuropsychiatry, Centre for Psychiatry Research, Department of Women's and Children's Health, Karolinska Institutet, Solna, Sweden.""}, {'ForeName': 'Nora', 'Initials': 'N', 'LastName': 'Choque-Olsson', 'Affiliation': ""Center of Neurodevelopmental Disorders (KIND), Division of Neuropsychiatry, Centre for Psychiatry Research, Department of Women's and Children's Health, Karolinska Institutet, Solna, Sweden.""}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Bölte', 'Affiliation': ""Center of Neurodevelopmental Disorders (KIND), Division of Neuropsychiatry, Centre for Psychiatry Research, Department of Women's and Children's Health, Karolinska Institutet, Solna, Sweden. sven.bolte@ki.se.""}]",Scientific reports,['10.1038/s41598-019-46396-1']
339,32086525,Use of an iPhone Application to Increase Adherence in Patients With Ulcerative Colitis in Remission: A Randomized Controlled Trial.,,2020,,['Patients With Ulcerative Colitis in Remission'],['iPhone Application'],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3697010', 'cui_str': 'Ulcerative colitis in remission (disorder)'}]","[{'cui': 'C0185125', 'cui_str': 'Application (attribute)'}]",[],,0.0852561,,"[{'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Ley', 'Affiliation': 'University of Wisconsin Department of Medicine, Madison, Wisconsin, USA.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Martin', 'Affiliation': 'University of Wisconsin-Madison School of Pharmacy, Madison, Wisconsin, USA.'}, {'ForeName': 'Freddy', 'Initials': 'F', 'LastName': 'Caldera', 'Affiliation': 'University of Wisconsin Division of Gastroenterology and Hepatology, Madison, Wisconsin, USA.'}]",Inflammatory bowel diseases,['10.1093/ibd/izaa024']
340,31182263,Optimal duration of dual antiplatelet therapy post percutaneous coronary intervention in acute coronary syndrome.,"Dual antiplatelet therapy (DAPT), with aspirin plus a P2Y12 inhibitor agent, is the cornerstone treatment after percutaneous coronary intervention for acute coronary syndrome. Based on randomized clinical trial using aspirin and clopidogrel, a DAPT duration of 12 months has been recommended after an acute coronary syndrome. Despite the development of more potent antiplatelet agents (i.e. prasugrel and ticagrelor) and the reduction in ischemic recurrences after acute coronary syndrome, 12 months DAPT currently remains the gold standard. However, a significant proportion of patients experience recurrent ischemic events beyond the first 12 months after an acute coronary syndrome. Meanwhile, with more effective antiplatelet agent, bleeding has become a major safety concern on DAPT. Therefore, the ischemic and bleeding risk balance is central considering the duration of DAPT after an acute coronary syndrome. This review aims to report the evidence for an optimization and individualization of DAPT duration after an acute coronary syndrome.",2020,"Despite the development of more potent antiplatelet agents (i.e. prasugrel and ticagrelor) and the reduction in ischemic recurrences after acute coronary syndrome, 12 months DAPT currently remains the gold standard.",['acute coronary syndrome'],"['aspirin plus a P2Y12 inhibitor agent', 'Dual antiplatelet therapy (DAPT', 'dual antiplatelet therapy post percutaneous coronary intervention', 'aspirin and clopidogrel']",['ischemic recurrences'],"[{'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}]","[{'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}]","[{'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}]",,0.0180581,"Despite the development of more potent antiplatelet agents (i.e. prasugrel and ticagrelor) and the reduction in ischemic recurrences after acute coronary syndrome, 12 months DAPT currently remains the gold standard.","[{'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Deharo', 'Affiliation': 'Département de Cardiologie, CHU Timone, Marseille, F-13385 France; C2VN, INSERM, INRA, AMU, France; Aix-Marseille Université, Faculté de Médecine, F-13385, Marseille, France. Electronic address: deharopierre@gmail.com.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Cuisset', 'Affiliation': 'Département de Cardiologie, CHU Timone, Marseille, F-13385 France; Aix-Marseille Université, Faculté de Médecine, F-13385, Marseille, France; Aix Marseille Univ, Inserm, Inra, C2VN, Marseille, France.'}]",Trends in cardiovascular medicine,['10.1016/j.tcm.2019.05.008']
341,31201005,Evolving trends in mechanical circulatory support: Clinical development of a fully magnetically levitated durable ventricular assist device.,"Early generation left ventricular assist devices (LVAD) for treatment of refractory heart failure attempted to mimic the pulsatility of a native heart and were bulky and less durable due to valves within the inflow and outflow pathways. The next disruption came with the introduction of continuous flow pumps characterized by a low-pulse pressure circulation. Since the mechanism of action did not involve displacement of blood, these pumps were much smaller and less noisy in part due to fewer moving parts. Such devices include the HeartMate II axial-flow pathway pump which is implanted thoraco-abdominally and the HVAD, a centrifugal-flow pathway pump which is smaller and is implanted entirely within the thoracic cavity and uses a combination of hydrodynamic and magnetic levitation of the internal rotor. These pumps improved survival compared with the early generation LVADs and in a trial, the HVAD demonstrated non-inferiority compared with the HeartMate II but with an increase in ischemic and hemorrhagic strokes. The HeartMate 3 LVAD is an intrapericardial centrifugal-flow pathway pump with a full magnetically levitated, frictionless rotor with a fixed intrinsic pulse. In a randomized trial, the HeartMate 3 ""hybrid"" pump was associated with near-elimination of pump thrombosis, a reduction in strokes of any type or severity and lower mucosal bleeding rates. Despite improvements in hemocompatibility, right heart failure and infections contribute to significant morbidity, and devices designed to be internally contained with a wireless power source and physiological flow characteristics are still required despite great strides in the field.",2020,"In a randomized trial, the HeartMate 3 ""hybrid"" pump was associated with near-elimination of pump thrombosis, a reduction in strokes of any type or severity and lower mucosal bleeding rates.",[],['Early generation left ventricular assist devices (LVAD'],"['strokes of any type or severity and lower mucosal bleeding rates', 'survival', 'ischemic and hemorrhagic strokes']",[],"[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}]","[{'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C2748540', 'cui_str': 'Mucosal bleeding'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0553692', 'cui_str': 'Haematencephalon'}]",,0.0324341,"In a randomized trial, the HeartMate 3 ""hybrid"" pump was associated with near-elimination of pump thrombosis, a reduction in strokes of any type or severity and lower mucosal bleeding rates.","[{'ForeName': 'Kiran', 'Initials': 'K', 'LastName': 'Sidhu', 'Affiliation': ""Brigham and Women's Hospital and Harvard Medical School, Boston, MA, United States.""}, {'ForeName': 'Phillip H', 'Initials': 'PH', 'LastName': 'Lam', 'Affiliation': ""Brigham and Women's Hospital and Harvard Medical School, Boston, MA, United States.""}, {'ForeName': 'Mandeep R', 'Initials': 'MR', 'LastName': 'Mehra', 'Affiliation': ""Brigham and Women's Hospital and Harvard Medical School, Boston, MA, United States. Electronic address: mmehra@bwh.harvard.edu.""}]",Trends in cardiovascular medicine,['10.1016/j.tcm.2019.05.013']
342,31107983,Maternal glycaemic control and risk of neonatal hypoglycaemia in Type 1 diabetes pregnancy: a secondary analysis of the CONCEPTT trial.,"AIMS


To examine the relationship between maternal glycaemic control and risk of neonatal hypoglycaemia using conventional and continuous glucose monitoring metrics in the Continuous Glucose Monitoring in Type 1 Diabetes Pregnancy Trial (CONCEPTT) participants.
METHODS


A secondary analysis of CONCEPTT involving 225 pregnant women and their liveborn infants. Antenatal glycaemia was assessed at 12, 24 and 34 weeks gestation. Intrapartum glycaemia was assessed by continuous glucose monitoring measures 24 hours prior to delivery. The primary outcome was neonatal hypoglycaemia defined as glucose concentration < 2.6 mmol/l and requiring intravenous dextrose.
RESULTS


Neonatal hypoglycaemia occurred in 57/225 (25.3%) infants, 21 (15%) term and 36 (40%) preterm neonates. During the second and third trimesters, mothers of infants with neonatal hypoglycaemia had higher HbA 1c  [48 ± 7 (6.6 ± 0.6) vs. 45 ± 7 (6.2 ± 0.6); P = 0.0009 and 50 ± 7 (6.7 ± 0.6) vs. 46 ± 7 (6.3 ± 0.6); P = 0.0001] and lower continuous glucose monitoring time-in-range (46% vs. 53%; P = 0.004 and 60% vs. 66%; P = 0.03). Neonates with hypoglycaemia had higher cord blood C-peptide concentrations [1416 (834, 2757) vs. 662 (417, 1086) pmol/l; P < 0.00001], birthweight > 97.7th centile (63% vs. 34%; P < 0.0001) and skinfold thickness (P ≤ 0.02). Intrapartum continuous glucose monitoring was available for 33 participants, with no differences between mothers of neonates with and without hypoglycaemia.
CONCLUSIONS


Modest increments in continuous glucose monitoring time-in-target (5-7% increase) during the second and third trimesters are associated with reduced risk for neonatal hypoglycaemia. While more intrapartum continuous glucose monitoring data are needed, the higher birthweight and skinfold measures associated with neonatal hypoglycaemia suggest that risk is related to fetal hyperinsulinemia preceding the immediate intrapartum period.",2019,"RESULTS


Neonatal hypoglycaemia occurred in 57/225 (25.3%) infants, 21 (15%) term and 36 (40%) preterm neonates.","['225 pregnant women and their liveborn infants', 'Type 1 Diabetes Pregnancy Trial (CONCEPTT) participants', 'Type 1 diabetes pregnancy', '33 participants, with no differences between mothers of neonates with and without hypoglycaemia']",['conventional and continuous glucose monitoring metrics'],"['Antenatal glycaemia', 'cord blood C-peptide concentrations', 'continuous glucose monitoring time', 'Maternal glycaemic control and risk of neonatal hypoglycaemia', 'Neonatal hypoglycaemia', 'skinfold thickness', 'Intrapartum glycaemia', 'continuous glucose monitoring time-in-range', 'neonatal hypoglycaemia defined as glucose concentration < 2.6 mmol/l and requiring intravenous dextrose']","[{'cui': 'C4517652', 'cui_str': '225 (qualifier value)'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0699680', 'cui_str': 'Metric'}]","[{'cui': 'C2828394', 'cui_str': 'Antenatal (qualifier value)'}, {'cui': 'C0162371', 'cui_str': 'Cord Blood'}, {'cui': 'C0006558', 'cui_str': 'Proinsulin C-Peptide'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C4523945', 'cui_str': 'Continuous glucose monitoring'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0158986', 'cui_str': 'Neonatal hypoglycemia (disorder)'}, {'cui': 'C0037302', 'cui_str': 'Skinfold Thickness'}, {'cui': 'C0456337', 'cui_str': 'Intrapartum (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C1287281', 'cui_str': 'Finding of glucose concentration, dipstick (finding)'}, {'cui': 'C4517633', 'cui_str': 'Two point six'}, {'cui': 'C1532563', 'cui_str': 'umol/mL'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0017725', 'cui_str': 'dextrose'}]",225.0,0.0937579,"RESULTS


Neonatal hypoglycaemia occurred in 57/225 (25.3%) infants, 21 (15%) term and 36 (40%) preterm neonates.","[{'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Yamamoto', 'Affiliation': 'Departments of Medicine and Obstetrics and Gynaecology, University of Calgary, Calgary, Canada.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Corcoy', 'Affiliation': ""Servei d'Endocrinologia i Nutrició, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.""}, {'ForeName': 'L E', 'Initials': 'LE', 'LastName': 'Donovan', 'Affiliation': 'Departments of Medicine and Obstetrics and Gynaecology, University of Calgary, Calgary, Canada.'}, {'ForeName': 'Z A', 'Initials': 'ZA', 'LastName': 'Stewart', 'Affiliation': 'Wellcome Trust-Medical Research Council Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Tomlinson', 'Affiliation': 'Department of Medicine, University Health Network, Toronto, Canada.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Beardsall', 'Affiliation': 'Department of Paediatrics, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'D S', 'Initials': 'DS', 'LastName': 'Feig', 'Affiliation': 'Department of Medicine, University of Toronto, Toronto, Canada.'}, {'ForeName': 'H R', 'Initials': 'HR', 'LastName': 'Murphy', 'Affiliation': 'Wellcome Trust-Medical Research Council Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetic medicine : a journal of the British Diabetic Association,['10.1111/dme.13988']
343,31278329,Synergistic mechanisms of Sanghuang-Danshen phytochemicals on postprandial vascular dysfunction in healthy subjects: A network biology approach based on a clinical trial.,"With the increased risk of cardiovascular disease, the use of botanicals for vascular endothelial dysfunction has intensified. Here, we explored the synergistic mechanisms of Sanghuang-Danshen (SD) phytochemicals on the homeostatic protection against high-fat-induced vascular dysfunction in healthy subjects, using a network biology approach, based on a randomised crossover clinical trial. Seventeen differential markers identified in blood samples taken at 0, 3 and 6 h post-treatment, together with 12SD phytochemicals, were mapped onto the network platform, termed the context-oriented directed associations. The resulting vascular sub-networks illustrated associations between 10 phytochemicals with 32 targets implicated in 143 metabolic/signalling pathways. The three key events included adhesion molecule production (ellagic acid, fumaric acid and cryptotanshinone; VCAM-1, ICAM-1 and PLA2G2A; fatty acid metabolism), platelet activation (ellagic acid, protocatechuic acid and tanshinone IIA; VEGFA, APAF1 and ATF3; mTOR, p53, Rap1 and VEGF signalling pathways) and endothelial inflammation (all phytochemicals, except cryptotanshinone; 29 targets, including TP53 and CASP3; MAPK and PI3K-Akt signalling pathways, among others). Our collective findings demonstrate a potential of SD to protect unintended risks of vascular dysfunction in healthy subjects, providing a deeper understanding of the complicated synergistic mechanisms of signature phytochemicals in SD.",2019,The resulting vascular sub-networks illustrated associations between 10 phytochemicals with 32 targets implicated in 143 metabolic/signalling pathways.,['healthy subjects'],"['Sanghuang-Danshen phytochemicals', 'Sanghuang-Danshen (SD) phytochemicals']","['adhesion molecule production (ellagic acid, fumaric acid and cryptotanshinone; VCAM-1, ICAM-1 and PLA2G2A; fatty acid metabolism), platelet activation (ellagic acid, protocatechuic acid and tanshinone IIA; VEGFA, APAF1 and ATF3; mTOR, p53, Rap1 and VEGF signalling pathways) and endothelial inflammation (all phytochemicals, except cryptotanshinone; 29 targets, including TP53 and CASP3; MAPK and PI3K-Akt signalling pathways, among others', 'postprandial vascular dysfunction']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0696940', 'cui_str': 'Dan-Shen'}, {'cui': 'C0577749', 'cui_str': 'Plant Bioactive Compounds'}]","[{'cui': 'C0001511', 'cui_str': 'Tissue Adhesions'}, {'cui': 'C0567416', 'cui_str': 'Molecule (substance)'}, {'cui': 'C0033268'}, {'cui': 'C0013900', 'cui_str': 'Ellagic Acid'}, {'cui': 'C0060825', 'cui_str': 'Fumaric acid'}, {'cui': 'C0056557', 'cui_str': 'cryptotanshinone'}, {'cui': 'C0078056', 'cui_str': 'CD106 Antigens'}, {'cui': 'C0063695', 'cui_str': 'CD54 Antigens'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0032173', 'cui_str': 'Platelet Activation'}, {'cui': 'C0072489', 'cui_str': 'protocatechuic acid'}, {'cui': 'C0897640', 'cui_str': 'tanshinone II A'}, {'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0577749', 'cui_str': 'Plant Bioactive Compounds'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0291573', 'cui_str': 'CASP3'}, {'cui': 'C0037080', 'cui_str': 'Signal Pathways'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}]",17.0,0.0284745,The resulting vascular sub-networks illustrated associations between 10 phytochemicals with 32 targets implicated in 143 metabolic/signalling pathways.,"[{'ForeName': 'Yeni', 'Initials': 'Y', 'LastName': 'Lim', 'Affiliation': 'Department of Nutritional Science and Food Management, Ewha Womans University, Seoul, 03760, Republic of Korea.'}, {'ForeName': 'Woochang', 'Initials': 'W', 'LastName': 'Hwang', 'Affiliation': 'Department of Bio and Brain Engineering, KAIST, Daejeon, 34141, Republic of Korea.'}, {'ForeName': 'Ji Yeon', 'Initials': 'JY', 'LastName': 'Kim', 'Affiliation': 'Department of Food Science and Technology, Seoul National University of Science and Technology, Seoul, 01811, Republic of Korea.'}, {'ForeName': 'Choong Hwan', 'Initials': 'CH', 'LastName': 'Lee', 'Affiliation': 'Department of Bioscience and Biotechnology, Konkuk University, Seoul, 05029, Republic of Korea.'}, {'ForeName': 'Yong-Jae', 'Initials': 'YJ', 'LastName': 'Kim', 'Affiliation': 'Department of Neurology, Ewha Womans University School of Medicine, Seoul, 07985, Republic of Korea.'}, {'ForeName': 'Doheon', 'Initials': 'D', 'LastName': 'Lee', 'Affiliation': 'Department of Bio and Brain Engineering, KAIST, Daejeon, 34141, Republic of Korea. dhlee@kaist.ac.kr.'}, {'ForeName': 'Oran', 'Initials': 'O', 'LastName': 'Kwon', 'Affiliation': 'Department of Nutritional Science and Food Management, Ewha Womans University, Seoul, 03760, Republic of Korea. orank@ewha.ac.kr.'}]",Scientific reports,['10.1038/s41598-019-46289-3']
344,30316810,Binge drinking and frequent or heavy drinking among adolescents: prevalence and associated factors.,"OBJECTIVE


To analyze the sociodemographic, school, and family factors associated with the patterns of binge drinking and frequent or heavy drinking among adolescents.
METHODS


This was a cross-sectional study, nested in a randomized controlled trial, of 6285 seventh and eighth grade adolescent students from Brazilian public schools. The associations between binge drinking (consumption of five or more doses of alcohol on a single occasion) in the last 12 months and frequent or heavy drinking (alcohol consumption on six or more days) in the last month and the several factors were analyzed through weighted logistic regression.
RESULTS


16.5% of the students reported binge drinking in the year before the interview and 2.2% reported frequent/heavy drinking in the previous month. The factors associated with binge drinking were cigarette smoking (OR=6.7, 95% CI=3.96; 11.23), use of marijuana (OR=2.2, 95% CI=1.17; 4.31), use of inhalant drugs (OR=3.0, 95% CI=1.98; 4.43), exposure to a drunk relative (OR=2.1, 95% C=1.67; 2.53), practice of bullying (OR=1.8, 95% CI=1.47; 2.17), verbal aggression (OR=1.7, 95%CI=1.40; 2.14), and intermediate/low school grades (OR=1.7, 95% CI=1.35; 2.20). The factors associated with frequent/heavy drinking were cigarette smoking (OR=2.5, 95% CI=1.16; 5.22), use of marijuana (OR=3.2, 95% CI=1.32; 7.72), and physical aggression (OR=2.2, 95% CI=1.36; 3.50).
CONCLUSIONS


The analyzed outcomes showed an association between the risk consumption of alcohol in early adolescence and low academic performance, involvement with other drugs, aggressiveness, and witnessing episodes of a family member's drunkenness. Considering the impact on public health of the damages caused by alcohol consumption during adolescence, these factors that showed such association should be considered in the development of preventive interventions.",2020,"The factors associated with frequent/heavy drinking were cigarette smoking (OR=2.5, 95% CI=1.16; 5.22), use of marijuana (OR=3.2, 95% CI=1.32; 7.72), and physical aggression (OR=2.2, 95% CI=1.36; 3.50).
","['6285 seventh and eighth grade adolescent students from Brazilian public schools', 'adolescents']",[],"['physical aggression', 'verbal aggression', ""risk consumption of alcohol in early adolescence and low academic performance, involvement with other drugs, aggressiveness, and witnessing episodes of a family member's drunkenness"", 'Binge drinking and frequent or heavy drinking', 'practice of bullying', 'frequent/heavy drinking', 'binge drinking', 'frequent or heavy drinking (alcohol consumption']","[{'cui': 'C0205441', 'cui_str': 'Seventh (qualifier value)'}, {'cui': 'C0205442', 'cui_str': 'Eighth (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0557800', 'cui_str': 'Public school (environment)'}]",[],"[{'cui': 'C0424323', 'cui_str': 'Physical aggression (finding)'}, {'cui': 'C0424322', 'cui_str': 'Verbal aggression (finding)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0036373', 'cui_str': 'Academic Performance'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0001807', 'cui_str': 'Aggression'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0001969', 'cui_str': 'Drunkenness'}, {'cui': 'C0596170', 'cui_str': 'Binge overeating'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0424318', 'cui_str': 'Bullying'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}]",6285.0,0.0304906,"The factors associated with frequent/heavy drinking were cigarette smoking (OR=2.5, 95% CI=1.16; 5.22), use of marijuana (OR=3.2, 95% CI=1.32; 7.72), and physical aggression (OR=2.2, 95% CI=1.36; 3.50).
","[{'ForeName': 'Lara Silvia Oliveira', 'Initials': 'LSO', 'LastName': 'Conegundes', 'Affiliation': 'Universidade Federal de São Paulo (Unifesp), Seção de Epidemiologia, Departamento de Medicina Preventiva, São Paulo, SP, Brazil.'}, {'ForeName': 'Juliana Y', 'Initials': 'JY', 'LastName': 'Valente', 'Affiliation': 'Universidade Federal de São Paulo (Unifesp), Seção de Epidemiologia, Departamento de Medicina Preventiva, São Paulo, SP, Brazil.'}, {'ForeName': 'Camila Bertini', 'Initials': 'CB', 'LastName': 'Martins', 'Affiliation': 'Universidade Federal de São Paulo (Unifesp), Seção de Bioestatística, Departamento de Medicina Preventiva, São Paulo, SP, Brazil.'}, {'ForeName': 'Solange', 'Initials': 'S', 'LastName': 'Andreoni', 'Affiliation': 'Universidade Federal de São Paulo (Unifesp), Seção de Bioestatística, Departamento de Medicina Preventiva, São Paulo, SP, Brazil.'}, {'ForeName': 'Zila M', 'Initials': 'ZM', 'LastName': 'Sanchez', 'Affiliation': 'Universidade Federal de São Paulo (Unifesp), Seção de Epidemiologia, Departamento de Medicina Preventiva, São Paulo, SP, Brazil. Electronic address: zila.sanchez@unifesp.br.'}]",Jornal de pediatria,['10.1016/j.jped.2018.08.005']
345,31604814,Closed-Loop Acoustic Stimulation Enhances Sleep Oscillations But Not Memory Performance.,"Slow oscillations and spindle activity during non-rapid eye movement sleep have been implicated in memory consolidation. Closed-loop acoustic stimulation has previously been shown to enhance slow oscillations and spindle activity during sleep and improve verbal associative memory. We assessed the effect of closed-loop acoustic stimulation during a daytime nap on a virtual reality spatial navigation task in 12 healthy human subjects in a randomized within-subject crossover design. We show robust enhancement of slow oscillation and spindle activity during sleep. However, no effects on behavioral performance were observed when comparing real versus sham stimulation. To explore whether memory enhancement effects were task specific and dependent on nocturnal sleep, in a second experiment with 19 healthy subjects, we aimed to replicate a previous study that used closed-loop acoustic stimulation to enhance memory for word pairs. The methods used were as close as possible to those used in the original study, except that we used a double-blind protocol, in which both subject and experimenter were unaware of the test condition. Again, we successfully enhanced slow oscillation and spindle power, but again did not strengthen associative memory performance with stimulation. We conclude that enhancement of sleep oscillations may be insufficient to enhance memory performance in spatial navigation or verbal association tasks, and provide possible explanations for lack of behavioral replication.",2019,Closed-loop acoustic stimulation has previously been shown to enhance slow oscillations and spindle activity during sleep and improve verbal associative memory.,"['19 healthy subjects', '12 healthy human subjects']","['Closed-loop acoustic stimulation', 'closed-loop acoustic stimulation']","['verbal associative memory', 'verbal memory performance', 'behavioral performance', 'memory performance']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0080105', 'cui_str': 'Human Subjects'}]","[{'cui': 'C0443183', 'cui_str': 'Closed loop (qualifier value)'}, {'cui': 'C0001164', 'cui_str': 'Stimulation, Auditory'}]","[{'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C1285654', 'cui_str': 'Ability to remember'}]",12.0,0.199326,Closed-loop acoustic stimulation has previously been shown to enhance slow oscillations and spindle activity during sleep and improve verbal associative memory.,"[{'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Henin', 'Affiliation': 'NYU Comprehensive Epilepsy Center, New York, New York 10016 Anli.liu@nyulangone.org simon.henin@nyulangone.org.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Borges', 'Affiliation': 'NYU Comprehensive Epilepsy Center, New York, New York 10016.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Shankar', 'Affiliation': 'NYU Comprehensive Epilepsy Center, New York, New York 10016.'}, {'ForeName': 'Cansu', 'Initials': 'C', 'LastName': 'Sarac', 'Affiliation': 'NYU Comprehensive Epilepsy Center, New York, New York 10016.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Melloni', 'Affiliation': 'NYU Comprehensive Epilepsy Center, New York, New York 10016.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Friedman', 'Affiliation': 'NYU Comprehensive Epilepsy Center, New York, New York 10016.'}, {'ForeName': 'Adeen', 'Initials': 'A', 'LastName': 'Flinker', 'Affiliation': 'NYU Comprehensive Epilepsy Center, New York, New York 10016.'}, {'ForeName': 'Lucas C', 'Initials': 'LC', 'LastName': 'Parra', 'Affiliation': 'Department of Biomedical Engineering, City College of New York, New York, New York 10031.'}, {'ForeName': 'Gyorgy', 'Initials': 'G', 'LastName': 'Buzsaki', 'Affiliation': 'New York University Langone Health, New York, NY 10016.'}, {'ForeName': 'Orrin', 'Initials': 'O', 'LastName': 'Devinsky', 'Affiliation': 'NYU Comprehensive Epilepsy Center, New York, New York 10016.'}, {'ForeName': 'Anli', 'Initials': 'A', 'LastName': 'Liu', 'Affiliation': 'NYU Comprehensive Epilepsy Center, New York, New York 10016 Anli.liu@nyulangone.org simon.henin@nyulangone.org.'}]",eNeuro,['10.1523/ENEURO.0306-19.2019']
346,32182353,Which Components of a Smartphone Walking App Help Users to Reach Personalized Step Goals? Results From an Optimization Trial.,"BACKGROUND


The Assistant to Lift your Level of activitY (Ally) app is a smartphone application that combines financial incentives with chatbot-guided interventions to encourage users to reach personalized daily step goals.
PURPOSE


To evaluate the effects of incentives, weekly planning, and daily self-monitoring prompts that were used as intervention components as part of the Ally app.
METHODS


We conducted an 8 week optimization trial with n = 274 insurees of a health insurance company in Switzerland. At baseline, participants were randomized to different incentive conditions (cash incentives vs. charity incentives vs. no incentives). Over the course of the study, participants were randomized weekly to different planning conditions (action planning vs. coping planning vs. no planning) and daily to receiving or not receiving a self-monitoring prompt. Primary outcome was the achievement of personalized daily step goals.
RESULTS


Study participants were more active and healthier than the general Swiss population. Daily cash incentives increased step-goal achievement by 8.1%, 95% confidence interval (CI): [2.1, 14.1] and, only in the no-incentive control group, action planning increased step-goal achievement by 5.8%, 95% CI: [1.2, 10.4]. Charity incentives, self-monitoring prompts, and coping planning did not affect physical activity. Engagement with planning interventions and self-monitoring prompts was low and 30% of participants stopped using the app over the course of the study.
CONCLUSIONS


Daily cash incentives increased physical activity in the short term. Planning interventions and self-monitoring prompts require revision before they can be included in future versions of the app. Selection effects and engagement can be important challenges for physical-activity apps.
CLINICAL TRIAL INFORMATION


This study was registered on ClinicalTrials.gov, NCT03384550.",2020,"Daily cash incentives increased step-goal achievement by 8.1%, 95% confidence interval (CI): [2.1, 14.1] and, only in the no-incentive control group, action planning increased step-goal achievement by 5.8%, 95% CI: [1.2, 10.4].",['n = 274 insurees of a health insurance company in Switzerland'],"['planning conditions (action planning vs. coping planning vs. no planning) and daily to receiving or not receiving a self-monitoring prompt', 'incentive conditions (cash incentives vs. charity incentives vs. no incentives']","['physical activity', 'step-goal achievement', 'achievement of personalized daily step goals']","[{'cui': 'C0021682', 'cui_str': 'Health Insurance'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}]","[{'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0588436', 'cui_str': 'Self-monitoring (regime/therapy)'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0007962', 'cui_str': 'Charities'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]",,0.0829464,"Daily cash incentives increased step-goal achievement by 8.1%, 95% confidence interval (CI): [2.1, 14.1] and, only in the no-incentive control group, action planning increased step-goal achievement by 5.8%, 95% CI: [1.2, 10.4].","[{'ForeName': 'Jan-Niklas', 'Initials': 'JN', 'LastName': 'Kramer', 'Affiliation': 'Institute of Technology Management (ITEM), University of St. Gallen, St. Gallen, Switzerland.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Künzler', 'Affiliation': 'Department of Management, Technology and Economics, ETH Zurich, Zurich, Switzerland.'}, {'ForeName': 'Varun', 'Initials': 'V', 'LastName': 'Mishra', 'Affiliation': 'Department of Computer Science, Dartmouth College, Hanover, NH, USA.'}, {'ForeName': 'Shawna N', 'Initials': 'SN', 'LastName': 'Smith', 'Affiliation': 'Institute for Social Research, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kotz', 'Affiliation': 'Department of Computer Science, Dartmouth College, Hanover, NH, USA.'}, {'ForeName': 'Urte', 'Initials': 'U', 'LastName': 'Scholz', 'Affiliation': 'Department of Psychology, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Elgar', 'Initials': 'E', 'LastName': 'Fleisch', 'Affiliation': 'Institute of Technology Management (ITEM), University of St. Gallen, St. Gallen, Switzerland.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Kowatsch', 'Affiliation': 'Institute of Technology Management (ITEM), University of St. Gallen, St. Gallen, Switzerland.'}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1093/abm/kaaa002']
347,31642726,A Randomized Study of a Strength Training Program to Prevent Injuries in Runners of the New York City Marathon.,"BACKGROUND


Lower extremity overuse injuries are common among runners, especially first-time marathoners. Hip abductor and quadriceps strengthening is often recommended to reduce running-related injuries.
HYPOTHESIS


A 12-week strength training program would decrease the rate of overuse injuries resulting in marathon noncompletion and improve race finishing time.
STUDY DESIGN


Randomized trial.
LEVEL OF EVIDENCE


Level 2.
METHODS


Twelve weeks before the New York City Marathon, first-time marathon runners age 18 years and older were randomized into a strength training group or an observation group. The strength training group was instructed to perform a 10-minute program 3 times weekly using written and video instruction. This program targeted the quadriceps, hip abductor, and core muscle groups. Injuries were self-reported through biweekly surveys, with major injuries being those that resulted in marathon noncompletion and minor injuries being those that impaired training or race performance.
RESULTS


A total of 720 runners were enrolled (mean age, 35.9 ± 9.4 years; 69.4% female), of whom 583 runners started the marathon and 579 completed it. The incidence of major injury was 8.9% and minor injury was 48.5%. Fifty two of 64 major injuries were overuse, of which 20 were bone stress injuries. The incidence of overuse injury resulting in marathon noncompletion was 7.1% in the strength training group and 7.3% in the observation group (risk ratio, 0.97; 95% CI, 0.57-1.63;  P  = 0.90). The mean finishing time was 5 hours 1 ± 60 minutes in the strength training group and 4 hours 58 ± 55 minutes in the observation group ( P  = 0.35).
CONCLUSION


There is a high prevalence of injury among first-time marathon runners, but this self-directed strength training program did not decrease overuse injury incidence resulting in marathon noncompletion.
CLINICAL RELEVANCE


Prevention strategies such as strength training need to be developed and evaluated through clinical trials to reduce the high prevalence of overuse injuries in runners, especially for high-risk populations such as first-time marathon runners.",2020,"The incidence of overuse injury resulting in marathon noncompletion was 7.1% in the strength training group and 7.3% in the observation group (risk ratio, 0.97; 95% CI, 0.57-1.63;  P  = 0.90).","['Injuries in Runners of the New York City Marathon', '720 runners were enrolled (mean age, 35.9 ± 9.4 years; 69.4% female), of whom 583 runners started the marathon and 579 completed it', 'Twelve weeks before the New York City Marathon, first-time marathon runners age 18 years and older', 'Fifty two of 64 major injuries were overuse, of which 20 were bone stress injuries']","['Strength Training Program', 'strength training', 'Hip abductor and quadriceps strengthening', 'strength training program', 'strength training group or an observation group']","['rate of overuse injuries', 'incidence of major injury', 'mean finishing time', 'incidence of overuse injury resulting in marathon noncompletion']","[{'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0027977', 'cui_str': 'New York City'}, {'cui': 'C4517865', 'cui_str': 'Seven hundred and twenty'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C4319570', 'cui_str': 'Fifty-two'}, {'cui': 'C0332677', 'cui_str': 'Major injury (morphologic abnormality)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0302523', 'cui_str': 'Observation'}]","[{'cui': 'C0035127', 'cui_str': 'Repetitive Stress Injury'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0332677', 'cui_str': 'Major injury (morphologic abnormality)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1706059', 'cui_str': 'Finish - dosing instruction imperative'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0332294', 'cui_str': 'Resulting in (attribute)'}]",20.0,0.0172539,"The incidence of overuse injury resulting in marathon noncompletion was 7.1% in the strength training group and 7.3% in the observation group (risk ratio, 0.97; 95% CI, 0.57-1.63;  P  = 0.90).","[{'ForeName': 'Brett G', 'Initials': 'BG', 'LastName': 'Toresdahl', 'Affiliation': 'Primary Care Sports Medicine Service, Hospital for Special Surgery, New York, New York.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'McElheny', 'Affiliation': 'Primary Care Sports Medicine Service, Hospital for Special Surgery, New York, New York.'}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Metzl', 'Affiliation': 'Primary Care Sports Medicine Service, Hospital for Special Surgery, New York, New York.'}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'Ammerman', 'Affiliation': 'Penn State College of Medicine, Hershey, Pennsylvania.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Chang', 'Affiliation': 'Atrium Health, New York, New York.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Kinderknecht', 'Affiliation': 'Primary Care Sports Medicine Service, Hospital for Special Surgery, New York, New York.'}]",Sports health,['10.1177/1941738119877180']
348,31590108,Randomized controlled trial of cryotherapy to prevent paclitaxel-induced peripheral neuropathy (RU221511I); an ACCRU trial.,"PURPOSE


This pilot trial aimed to assess if cooling hands and feet with crushed ice during receipt of paclitaxel helps prevent peripheral neuropathy.
METHODS


This prospective, randomized trial compared cryotherapy to standard care in patients initiating paclitaxel weekly x 12. For those on cryotherapy, hands and feet were cooled starting 15 min prior to and ending 15 min after each paclitaxel dose. EORTC QLQ-CIPN20 was completed at baseline, weekly x12, then monthly x6. Area under the curve (AUC) was calculated for subscale scores, adjusting for baseline, and compared between arms (Wilcoxon rank-sum test). Cross-study comparisons used data from 2 prior similarly-conducted neuropathy trials.
RESULTS


Forty-six patients were accrued. Three withdrew and one was ineligible. Of the remaining 42 (21 cryotherapy, 21 control), 39 (19 cryotherapy, 20 control) were analyzable for AUC. Cryotherapy was well tolerated, but the AUC of the CIPN20 sensory scores over 12 weeks of paclitaxel was not found to differ between the study arms (mean difference 3.45, 95% CI -3.13 to 10.02, p = 0.26). However, the control arm of the current trial experienced less neuropathy than did the placebo arms of two previous similar trials. When our cryotherapy arm was compared to the combined control arms from all three trials, the cryotherapy arm had less neuropathy (Wilcoxon Rank-Sum p = 0.01).
CONCLUSION


While there was no difference in CIPN20 scores identified between the 2 study arms in the current phase II trial, further investigation is needed given that the control arm experienced less neuropathy than was expected.",2019,"Cryotherapy was well tolerated, but the AUC of the CIPN20 sensory scores over 12 weeks of paclitaxel was not found to differ between the study arms (mean difference 3.45, 95% CI -3.13 to 10.02, p = 0.26).","['patients initiating paclitaxel weekly x 12', 'Forty-six patients were accrued']","['Cryotherapy', 'placebo', 'cryotherapy', 'paclitaxel']","['CIPN20 scores', 'Area under the curve (AUC', 'CIPN20 sensory scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}]","[{'cui': 'C4551716', 'cui_str': 'Cryotherapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}]",46.0,0.0622765,"Cryotherapy was well tolerated, but the AUC of the CIPN20 sensory scores over 12 weeks of paclitaxel was not found to differ between the study arms (mean difference 3.45, 95% CI -3.13 to 10.02, p = 0.26).","[{'ForeName': 'Kathryn J', 'Initials': 'KJ', 'LastName': 'Ruddy', 'Affiliation': 'Department of Oncology, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA. Electronic address: Ruddy.kathryn@mayo.edu.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Le-Rademacher', 'Affiliation': 'Department of Biostatistics, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA.'}, {'ForeName': 'Mario E', 'Initials': 'ME', 'LastName': 'Lacouture', 'Affiliation': 'Department of Dermatology, Memorial Sloan Kettering Cancer Center, 1275 York Ave., New York, NY, 10065, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Wilkinson', 'Affiliation': 'Inova Hematology Oncology, 8501 Arlington Blvd., Suite 340, Fairfax, VA, 22031, USA.'}, {'ForeName': 'Adedayo A', 'Initials': 'AA', 'LastName': 'Onitilo', 'Affiliation': 'Marshfield Clinic - Weston Center, 3501 Cranberry Blvd., Weston, WI, 54476, USA.'}, {'ForeName': 'Amy C', 'Initials': 'AC', 'LastName': 'Vander Woude', 'Affiliation': 'Cancer and Hematology Centers of Western Michigan, 145 Michigan St. NE, #3100, Grand Rapids, MI, 49503, USA.'}, {'ForeName': 'Maria T', 'Initials': 'MT', 'LastName': 'Grosse-Perdekamp', 'Affiliation': 'Carle Cancer Center, 509 W. University Ave., Urbana, IL, 61801, USA.'}, {'ForeName': 'Travis', 'Initials': 'T', 'LastName': 'Dockter', 'Affiliation': 'Department of Biostatistics, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA.'}, {'ForeName': 'Angelina D', 'Initials': 'AD', 'LastName': 'Tan', 'Affiliation': 'Department of Biostatistics, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Beutler', 'Affiliation': 'Department of Oncology, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA.'}, {'ForeName': 'Charles L', 'Initials': 'CL', 'LastName': 'Loprinzi', 'Affiliation': 'Department of Oncology, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA.'}]","Breast (Edinburgh, Scotland)",['10.1016/j.breast.2019.09.011']
349,32078436,Cocoa to Improve Walking Performance in Older People With Peripheral Artery Disease: The COCOA-PAD Pilot Randomized Clinical Trial.,"RATIONALE


Cocoa and its major flavanol component, epicatechin, have therapeutic properties that may improve limb perfusion and increase calf muscle mitochondrial activity in people with lower extremity peripheral artery disease (PAD).
OBJECTIVE


In a phase II randomized clinical trial, to assess whether 6 months of cocoa improved walking performance in people with PAD, compared with placebo.
METHODS AND RESULTS


Six-month double-blind, randomized clinical trial in which participants with PAD were randomized to either cocoa beverage versus placebo beverage. The cocoa beverage contained 15 g of cocoa and 75 mg of epicatechin daily. The identical appearing placebo contained neither cocoa nor epicatechin. The 2 primary outcomes were 6-month change in 6-minute walk distance measured 2.5 hours after a study beverage at 6-month follow-up and 24 hours after a study beverage at 6-month follow-up, respectively. A 1-sided  P <0.10 was considered statistically significant. Of 44 PAD participants randomized (mean age, 72.3 years [±7.1]; mean ankle brachial index, 0.66 [±0.15]), 40 (91%) completed follow-up. Adjusting for smoking, race, and body mass index, cocoa improved 6-minute walk distance at 6-month follow-up by 42.6 m ([90% CI, +22.2 to +∞]  P =0.005) at 2.5 hours after a final study beverage and by 18.0 m ([90% CI, -1.7 to +∞]  P =0.12) at 24 hours after a study beverage, compared with placebo. In calf muscle biopsies, cocoa improved mitochondrial COX (cytochrome c oxidase) activity ( P =0.013), increased capillary density ( P =0.014), improved calf muscle perfusion ( P =0.098), and reduced central nuclei ( P =0.033), compared with placebo.
CONCLUSIONS


These preliminary results suggest a therapeutic effect of cocoa on walking performance in people with PAD. Further study is needed to definitively determine whether cocoa significantly improves walking performance in people with PAD.
CLINICAL TRIAL REGISTRATION


URL: http://www.clinicaltrials.gov. Unique identifier: NCT02876887. Visual Overview: An online visual overview is available for this article.",2020,"In calf muscle biopsies, cocoa improved mitochondrial cytochrome c oxidase activity (P=0.013), increased capillary density (P=0.014), improved calf muscle perfusion (P=0.098), and reduced central nuclei (P=0.024), compared to placebo.  ","['people with lower extremity peripheral artery disease (PAD', 'Older People With Peripheral Artery Disease', '44 PAD participants randomized (mean age: 72.3 years (+7.1), mean ankle brachial index 0.66 (+0.15)), 40 (91%) completed follow-up', 'participants with PAD', 'people with PAD']","['placebo', 'cocoa beverage vs. placebo beverage', 'cocoa nor epicatechin', 'cocoa', 'Cocoa']","['mitochondrial cytochrome c oxidase activity', 'Walking Performance', 'calf muscle perfusion', 'six-month change in six-minute walk distance', 'walking performance', 'capillary density', 'reduced central nuclei']","[{'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Artery Disease'}, {'cui': 'C0441601', 'cui_str': 'Padding (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1328319', 'cui_str': 'Ankle Brachial Index'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521844', 'cui_str': 'Cocoa'}, {'cui': 'C0005329', 'cui_str': 'Beverages'}, {'cui': 'C0014485', 'cui_str': '(2R,3R)-2-(3,4-Dihydroxyphenyl)-3,5,7-chromanetriol'}]","[{'cui': 'C0010760', 'cui_str': 'Electron Transport Complex IV'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0448482', 'cui_str': 'Posterior crural muscle structure'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}, {'cui': 'C0006901', 'cui_str': 'Capillaries'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0007763', 'cui_str': 'Central Nuclei'}]",,0.668891,"In calf muscle biopsies, cocoa improved mitochondrial cytochrome c oxidase activity (P=0.013), increased capillary density (P=0.014), improved calf muscle perfusion (P=0.098), and reduced central nuclei (P=0.024), compared to placebo.  ","[{'ForeName': 'Mary M', 'Initials': 'MM', 'LastName': 'McDermott', 'Affiliation': 'From the Departments of Medicine (M.M.M., K.D., L.L., D.L.-J., D.Z.), Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Criqui', 'Affiliation': 'Department of Family Medicine, University of California at San Diego (M.H.C.).'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Domanchuk', 'Affiliation': 'From the Departments of Medicine (M.M.M., K.D., L.L., D.L.-J., D.Z.), Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Ferrucci', 'Affiliation': 'Division of Intramural Research, National Institute on Aging, Baltimore, MD (L.F.).'}, {'ForeName': 'Jack M', 'Initials': 'JM', 'LastName': 'Guralnik', 'Affiliation': 'Department of Epidemiology, University of Maryland, Baltimore (J.M.G.).'}, {'ForeName': 'Melina R', 'Initials': 'MR', 'LastName': 'Kibbe', 'Affiliation': 'Department of Surgery, University of North Carolina School of Medicine, Chapel Hill (M.R.K.).'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Kosmac', 'Affiliation': 'Department of Rehabilitation Sciences, University of Kentucky College of Health Sciences, Lexington (K.K., C.A.P.).'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Kramer', 'Affiliation': 'Department of Radiology and Medical Imaging, University of Virginia Health System, Charlottesville (C.M.K.).'}, {'ForeName': 'Christiaan', 'Initials': 'C', 'LastName': 'Leeuwenburgh', 'Affiliation': 'Department of Aging and Geriatric Research, University of Florida, Gainesville (C.L.).'}, {'ForeName': 'Lingyu', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'From the Departments of Medicine (M.M.M., K.D., L.L., D.L.-J., D.Z.), Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Lloyd-Jones', 'Affiliation': 'From the Departments of Medicine (M.M.M., K.D., L.L., D.L.-J., D.Z.), Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Charlotte A', 'Initials': 'CA', 'LastName': 'Peterson', 'Affiliation': 'Department of Rehabilitation Sciences, University of Kentucky College of Health Sciences, Lexington (K.K., C.A.P.).'}, {'ForeName': 'Tamar S', 'Initials': 'TS', 'LastName': 'Polonsky', 'Affiliation': 'Department of Medicine, University of Chicago, IL (T.S.P.).'}, {'ForeName': 'James H', 'Initials': 'JH', 'LastName': 'Stein', 'Affiliation': 'Department of Medicine, University of Wisconsin, Madison (J.H.S.).'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Sufit', 'Affiliation': 'Neurology (R.S.), Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Van Horn', 'Affiliation': 'Preventive Medicine (M.M.M., D.L.-J., L.V.H., L.Z.), Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Villarreal', 'Affiliation': 'Divisions of Cardiology (F.V.), University of San Diego, CA.'}, {'ForeName': 'Dongxue', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'From the Departments of Medicine (M.M.M., K.D., L.L., D.L.-J., D.Z.), Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Lihui', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': 'Preventive Medicine (M.M.M., D.L.-J., L.V.H., L.Z.), Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Tian', 'Affiliation': 'Department of Health Research and Policy, Stanford University, CA (L.T.).'}]",Circulation research,['10.1161/CIRCRESAHA.119.315600']
350,32246743,Rivaroxaban for treatment of pediatric venous thromboembolism. An Einstein-Jr phase 3 dose-exposure-response evaluation.,"BACKGROUND


Recently, the randomized EINSTEIN-Jr study showed similar efficacy and safety for rivaroxaban and standard anticoagulation for treatment of pediatric venous thromboembolism (VTE). The rivaroxaban dosing strategy was established based on phase 1 and 2 data in children and through pharmacokinetic (PK) modeling.
METHODS


Rivaroxaban treatment with tablets or the newly developed granules-for-oral suspension formulation was bodyweight-adjusted and administered once-daily, twice-daily, or thrice-daily for children with bodyweights of ≥30, ≥12 to <30, and <12 kg, respectively. Previously, these regimens were confirmed for children weighing ≥20 kg but only predicted in those <20 kg. Based on sparse blood sampling, the daily area under the plasma concentration-time curve [AUC (0-24)ss  ] and trough [C trough,ss  ] and maximum [C max,ss  ] steady-state plasma concentrations were derived using population PK modeling. Exposure-response graphs were generated to evaluate the potential relationship of individual PK parameters with recurrent VTE, repeat imaging outcomes, and bleeding or adverse events. A taste-and-texture questionnaire was collected for suspension-recipients.
RESULTS


Of the 335 children (aged 0-17 years) allocated to rivaroxaban, 316 (94.3%) were evaluable for PK analyses. Rivaroxaban exposures were within the adult exposure range. No clustering was observed for any of the PK parameters with efficacy, bleeding, or adverse event outcomes. Results were similar for the tablet and suspension formulation. Acceptability and palatability of the suspension were favorable.
DISCUSSION


Based on this analysis and the recently documented similar efficacy and safety of rivaroxaban compared with standard anticoagulation, we conclude that bodyweight-adjusted pediatric rivaroxaban regimens with either tablets or suspension are validated and provide for appropriate treatment of children with VTE.",2020,"No clustering was observed for any of the PK parameters with efficacy, bleeding, or adverse event outcomes.","['pediatric venous thromboembolism', 'children with VTE', 'pediatric venous thromboembolism (VTE', '335 children (aged 0-17 years) allocated to']","['Rivaroxaban', 'rivaroxaban']","['Acceptability and palatability', 'individual PK parameters with recurrent VTE, repeat imaging outcomes, and bleeding or adverse events', 'plasma concentration-time curve [AUC (0-24)ss  ] and trough [C trough,ss  ] and maximum [C max,ss  ] steady-state plasma concentrations', 'PK parameters with efficacy, bleeding, or adverse event outcomes']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0630906', 'cui_str': 'vinyltriethoxysilane'}, {'cui': 'C4709307', 'cui_str': '335'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0630906', 'cui_str': 'vinyltriethoxysilane'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",335.0,0.0324861,"No clustering was observed for any of the PK parameters with efficacy, bleeding, or adverse event outcomes.","[{'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Young', 'Affiliation': ""Children's Hospital Los Angeles, University of Southern California Keck School of Medicine, Los Angeles, CA, USA.""}, {'ForeName': 'Anthonie W A', 'Initials': 'AWA', 'LastName': 'Lensing', 'Affiliation': 'Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Monagle', 'Affiliation': ""Department of Clinical Haematology, Royal Children's Hospital, Haematology Research Murdoch Children's Research Institute, Parkville, Vic., Australia.""}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Male', 'Affiliation': 'Department of Paediatrics, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Kirstin', 'Initials': 'K', 'LastName': 'Thelen', 'Affiliation': 'Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Willmann', 'Affiliation': 'Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Joseph S', 'Initials': 'JS', 'LastName': 'Palumbo', 'Affiliation': ""Cancer and Blood Diseases Institute, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Riten', 'Initials': 'R', 'LastName': 'Kumar', 'Affiliation': ""Nationwide Children's Hospital, The Ohio State University, Columbus, OH, USA.""}, {'ForeName': 'Ildar', 'Initials': 'I', 'LastName': 'Nurmeev', 'Affiliation': 'Kazan State Medical University, Kazan, Russia.'}, {'ForeName': 'Kerry', 'Initials': 'K', 'LastName': 'Hege', 'Affiliation': 'Riley Hospital For Children at IU Health, Indianapolis, IN, USA.'}, {'ForeName': 'Fanny', 'Initials': 'F', 'LastName': 'Bajolle', 'Affiliation': 'M3C-Necker Enfants malades, Université Paris Descartes, Sorbonne Paris Cité, Paris, France.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Connor', 'Affiliation': ""The Noah's Ark Children's Hospital for Wales, Cardiff, UK.""}, {'ForeName': 'Hélène L', 'Initials': 'HL', 'LastName': 'Hooimeijer', 'Affiliation': ""Department of Hematology and Oncology, Beatrix Children's Hospital, University Medical Center Groningen, Groningen, The Netherlands.""}, {'ForeName': 'Marcela', 'Initials': 'M', 'LastName': 'Torres', 'Affiliation': ""Department of Hematology and Oncology, Cook Children's Medical Center, Fort Worth, TX, USA.""}, {'ForeName': 'Anthony K C', 'Initials': 'AKC', 'LastName': 'Chan', 'Affiliation': ""McMaster Children's Hospital, Hamilton, ON, Canada.""}, {'ForeName': 'Gili', 'Initials': 'G', 'LastName': 'Kenet', 'Affiliation': 'Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Holzhauer', 'Affiliation': 'Department of Pediatric Hematology and Oncology, Charité University Medicine, Berlin, Germany.'}, {'ForeName': 'Amparo', 'Initials': 'A', 'LastName': 'Santamaría', 'Affiliation': ""Hemostasis and Thrombosis Unit, Department of Hematology, University Hospital Vall d'Hebron, Barcelona, Spain.""}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Amedro', 'Affiliation': 'Paediatric and Congenital Cardiology Department, M3C Regional Reference Centre, Montpellier University Hospital, PhyMedExp, INSERM, CNRS, Montpellier, France.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Beyer-Westendorf', 'Affiliation': 'Division of Haematology and Haemostaseology, Department of Medicine I, Department of Haematology, University Hospital ""Carl Gustav Carus"" Dresden, King\'s Thrombosis Service, King\'s College London, London, UK.'}, {'ForeName': 'Ida', 'Initials': 'I', 'LastName': 'Martinelli', 'Affiliation': ""A. Bianchi Bonomi Hemophilia and Thrombosis Center, Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico, Milano, Italy.""}, {'ForeName': 'M Patricia', 'Initials': 'MP', 'LastName': 'Massicotte', 'Affiliation': 'Department of Paediatrics, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'William T', 'Initials': 'WT', 'LastName': 'Smith', 'Affiliation': 'Bayer U.S., LLC, Whippany, NJ, USA.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Berkowitz', 'Affiliation': 'Bayer U.S., LLC, Whippany, NJ, USA.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Schmidt', 'Affiliation': 'Department of Pharmaceutics, Center for Pharmacometrics and Systems Pharmacology, University of Florida, OR, USA.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Price', 'Affiliation': 'Division of Pediatric Hematology/Oncology, Department of Pediatrics, Dalhousie University, IWK Health Centre, Halifax, NS, Canada.'}, {'ForeName': 'Martin H', 'Initials': 'MH', 'LastName': 'Prins', 'Affiliation': 'Department of Clinical Epidemiology and Medical Technology Assessment, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Dagmar', 'Initials': 'D', 'LastName': 'Kubitza', 'Affiliation': 'Bayer AG, Wuppertal, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of thrombosis and haemostasis : JTH,['10.1111/jth.14813']
351,32119803,"Biochemical, Anthropometric, and Physiological Responses to Carbohydrate-Restricted Diets Versus a Low-Fat Diet in Obese Adults: A Randomized Crossover Trial.","Some research supports high-fat carbohydrate (CHO)-restricted diets for weight and fat loss and improvement of cardiovascular disease risk factors. To test this, a randomized crossover study was designed. Subjects (17 obese men and women [BMI: 30-38 kg/m 2 ]) were fed three diets (supplying 1600 and 2200 kilocalories (kcal)/day for women and men, respectively) for 4 weeks, with each trial separated by 4-week washout periods. One CHO-restricted diet (10% CHO, 50% fat, and 40% protein content) was rich in plant foods and mushrooms, while the other CHO-restricted diet included more animal foods (10% CHO, 60% fat, and 30% protein content). The third diet was lower in fat and protein content (LF) and higher in CHOs (61% CHO, 21% fat, and 18% protein content). Body composition was assessed through hydrostatic weighing before and after each diet trial. Fasting blood samples were collected weekly for analysis of hormones and lipids. Data were analyzed through repeated measures analysis of variance with  post hoc  paired comparison  t -tests. Weight and fat loss were similar ( P  > .05) among trials. Subjects lost lean mass ( P  < .05) during CHO-restricted trials, but not in the LF trial. Insulin concentrations decreased ( P  < .05) during the CHO-restricted trial and tended ( P  = .05) to decrease during the LF trial. Total cholesterol decreased ( P  < .05) for all trials; however, high-density lipoprotein cholesterol decreased ( P  < .05) and triacylglycerols were higher ( P  < .05) following the LF trial. Taken together, energy restriction regardless of diet composition promoted similar weight loss; however, CHO-restricted diets based on either plants/mushrooms or animal foods elicited a more beneficial lipid-altering effect in comparison with the LF diet.",2020,"Total cholesterol decreased ( P  < .05) for all trials; however, high-density lipoprotein cholesterol decreased ( P  < .05) and triacylglycerols were higher ( P  < .05) following the LF trial.","['Obese Adults', 'Subjects (17 obese men and women [BMI: 30-38\u2009kg/m 2 ']","['fed three diets (supplying 1600 and 2200 kilocalories (kcal)/day', 'Carbohydrate-Restricted Diets Versus a Low-Fat Diet']","['high-density lipoprotein cholesterol', 'fat and protein content (LF) and higher in CHOs', 'triacylglycerols', 'Total cholesterol', 'Fasting blood samples', 'Body composition', 'Weight and fat loss', 'Insulin concentrations']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C1875802', 'cui_str': 'Healthcare supplies'}, {'cui': 'C4517592', 'cui_str': '1600'}, {'cui': 'C4517651', 'cui_str': 'Two thousand two hundred'}, {'cui': 'C0439259', 'cui_str': 'kilocalorie'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0242970', 'cui_str': 'Fat-Restricted Diet'}]","[{'cui': 'C0023822', 'cui_str': 'High Density Lipoprotein Cholesterol'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",17.0,0.043574,"Total cholesterol decreased ( P  < .05) for all trials; however, high-density lipoprotein cholesterol decreased ( P  < .05) and triacylglycerols were higher ( P  < .05) following the LF trial.","[{'ForeName': 'Mayumi', 'Initials': 'M', 'LastName': 'Petrisko', 'Affiliation': 'School of Exercise and Nutritional Sciences, San Diego State University, San Diego, California, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Kloss', 'Affiliation': 'School of Exercise and Nutritional Sciences, San Diego State University, San Diego, California, USA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Bradley', 'Affiliation': 'School of Exercise and Nutritional Sciences, San Diego State University, San Diego, California, USA.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Birrenkott', 'Affiliation': 'School of Exercise and Nutritional Sciences, San Diego State University, San Diego, California, USA.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Spindler', 'Affiliation': 'School of Exercise and Nutritional Sciences, San Diego State University, San Diego, California, USA.'}, {'ForeName': 'Zachary S', 'Initials': 'ZS', 'LastName': 'Clayton', 'Affiliation': 'School of Exercise and Nutritional Sciences, San Diego State University, San Diego, California, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Kern', 'Affiliation': 'School of Exercise and Nutritional Sciences, San Diego State University, San Diego, California, USA.'}]",Journal of medicinal food,['10.1089/jmf.2019.0266']
352,32202507,Development and Assessment of a Gastroscopy Electronic Learning System for Primary Learners: Randomized Controlled Trial.,"BACKGROUND


Endoscopic examination is a popular and routine procedure for the diagnosis and treatment of gastrointestinal (GI) diseases. Skilled endoscopists are in great demand in clinical practice, but the training process for beginners to become endoscopy specialists is fairly long. Convenience and a self-paced, learner-centered approach make electronic learning (e-learning) an excellent instructional prospect.
OBJECTIVE


This study aimed to develop and apply an e-learning system in gastroscopy teaching and learning and to evaluate its effectiveness and user satisfaction.
METHODS


The e-learning software Gastroscope Roaming System was developed for primary learners. The system simulates the real structure of the upper gastrointestinal (UGI) tract to teach the main characteristics of gastroscopy under both normal conditions and conditions of common UGI tract diseases. A randomized controlled trial was conducted. Participants were randomly allocated to an e-learning group (EG)or a non-e-learning control group after a pretest. On completing the training, participants undertook a posttest and gastroscopy examination. In addition, the EG completed a satisfaction questionnaire.
RESULTS


Of the 44 volunteers, 41 (93%) completed the gastroscopy learning and testing components. No significant pretest differences were found between the intervention and control groups (mean 50.86, SD 6.12 vs mean 50.76, SD 6.88; P=.96). After 1 month of learning, the EG's posttest scores were higher (mean 83.70, SD 5.99 vs mean 78.76, SD 7.58; P=.03) and improved more (P=.01) than those of the control group, with better performance in the gastroscopy examination (mean 91.05, SD 4.58 vs mean 84.38, SD 5.19; P<.001). Overall, 85% (17/20) of the participants were satisfied with the e-learning system, and 95% (19/20) of the participants considered it successful.
CONCLUSIONS


E-learning is an effective educational strategy for primary learners to acquire skills in gastroscopy examination and endoscopic imaging of the GI tract.
TRIAL REGISTRATION


Chinese Clinical Trial Registry ChiCTR-IOR-17013091; http://www.chictr.org.cn/showproj.aspx?proj=22142.",2020,"CONCLUSIONS


E-learning is an effective educational strategy for primary learners to acquire skills in gastroscopy examination and endoscopic imaging of the GI tract.
","['44 volunteers, 41 (93%) completed the gastroscopy learning and testing components', 'Primary Learners']","['Gastroscopy Electronic Learning System', 'Convenience and a self-paced, learner-centered approach make electronic learning (e-learning', 'e-learning group (EG)or a non-e-learning control']",[],"[{'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0017195', 'cui_str': 'Gastroscopy'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}]","[{'cui': 'C0017195', 'cui_str': 'Gastroscopy'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",[],44.0,0.153367,"CONCLUSIONS


E-learning is an effective educational strategy for primary learners to acquire skills in gastroscopy examination and endoscopic imaging of the GI tract.
","[{'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Department of Gastroenterology and Hepatology, The Second Affiliated Hospital of Harbin Medical University, Harbin, China.'}, {'ForeName': 'Guoqing', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': 'Department of Gastroenterology and Hepatology, The Second Affiliated Hospital of Harbin Medical University, Harbin, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Gastroenterology and Hepatology, The Second Affiliated Hospital of Harbin Medical University, Harbin, China.'}, {'ForeName': 'Wanying', 'Initials': 'W', 'LastName': 'Xu', 'Affiliation': 'Department of Gastroenterology and Hepatology, The Second Affiliated Hospital of Harbin Medical University, Harbin, China.'}, {'ForeName': 'Ningning', 'Initials': 'N', 'LastName': 'Yang', 'Affiliation': 'Department of Gastroenterology and Hepatology, The Second Affiliated Hospital of Harbin Medical University, Harbin, China.'}, {'ForeName': 'Haoyuan', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Gastroenterology and Hepatology, The Second Affiliated Hospital of Harbin Medical University, Harbin, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'Department of Gastroenterology and Hepatology, The Second Affiliated Hospital of Harbin Medical University, Harbin, China.'}, {'ForeName': 'Kunpeng', 'Initials': 'K', 'LastName': 'Luo', 'Affiliation': 'Department of Gastroenterology and Hepatology, The Second Affiliated Hospital of Harbin Medical University, Harbin, China.'}, {'ForeName': 'Shizhu', 'Initials': 'S', 'LastName': 'Jin', 'Affiliation': 'Department of Gastroenterology and Hepatology, The Second Affiliated Hospital of Harbin Medical University, Harbin, China.'}]",Journal of medical Internet research,['10.2196/16233']
353,32171721,A Randomized Trial of Recombinant Human C1-Esterase-Inhibitor in the Prevention of Contrast-Induced Kidney Injury.,"OBJECTIVES


This study sought to determine the efficacy profile and safety of recombinant human C1 esterase inhibitor (rhC1INH) in the prevention of contrast-associated acute kidney injury after elective coronary angiography.
BACKGROUND


Contrast-associated acute kidney injury is caused by tubular cytotoxicity and ischemia/reperfusion injury. rhC1INH is effective in reducing renal ischemia/reperfusion injury in experimental models.
METHODS


In this placebo-controlled, double-blind, single-center trial 77 patients with chronic kidney disease were randomized to receive 50 IU/kg rhC1INH before and 4 h after elective coronary angiography or placebo. The primary outcome was the peak change of urinary neutrophil gelatinase-associated lipocalin within 48 h, a surrogate marker of kidney injury.
RESULTS


Median peak change of urinary neutrophil gelatinase-associated lipocalin was lower in the rhC1INH group (4.7 ng/ml vs. 22.5 ng/ml; p = 0.038) in the per-protocol population but not in the modified intention-to-treat analysis, and in patients with percutaneous coronary interventions (median, 1.8 ng/ml vs. 26.2 ng/ml; p = 0.039 corresponding to a median proportion peak change of 11% vs. 205%; p = 0.002). The incidence of a cystatin C increase ≥10% within 24 h was lower in the rhC1INH group (16% vs. 33%; p = 0.045), whereas the frequency of contrast-associated acute kidney injury was comparable. Adverse events during a 3-month follow-up were similarly distributed.
CONCLUSIONS


Administration of rhC1INH before coronary angiography may attenuate renal injury as reflected by urinary neutrophil gelatinase-associated lipocalin and cystatin C. The safety profile of rhC1INH was favorable in a patient population with multiple comorbidities. (Recombinant Human C1 Esterase Inhibitor in the Prevention of Contrast-induced Nephropathy in High-risk Subjects [PROTECT]; NCT02869347).",2020,"RESULTS


Median peak change of urinary neutrophil gelatinase-associated lipocalin was lower in the rhC1INH group (4.7 ng/ml vs. 22.5 ng/ml; p = 0.038) in the per-protocol population but not in the modified intention-to-treat analysis, and in patients with percutaneous coronary interventions (median, 1.8 ng/ml vs. 26.2 ng/ml; p = ","['77 patients with chronic kidney disease', 'patient\xa0population with multiple comorbidities', 'contrast-associated acute kidney injury after elective coronary angiography']","['rhC1INH', 'Recombinant Human C1 Esterase Inhibitor', 'placebo', 'RhC1INH', '50 IU/kg rhC1INH before and 4\xa0h after elective coronary angiography or placebo', 'recombinant human C1 esterase inhibitor (rhC1INH', 'Recombinant Human C1-Esterase-Inhibitor']","['Median peak change of urinary neutrophil gelatinase-associated lipocalin', 'peak change of urinary neutrophil gelatinase-associated lipocalin within 48 h, a surrogate marker of kidney injury', 'Adverse events', 'frequency of contrast-associated acute kidney injury', 'incidence of a cystatin C']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C2609414', 'cui_str': 'Acute Renal Injury'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0085532', 'cui_str': 'Angiography of coronary arteries'}]","[{'cui': 'C2366367', 'cui_str': 'C1 esterase inhibitor (human)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439463', 'cui_str': 'international unit/kilogram'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0085532', 'cui_str': 'Angiography of coronary arteries'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C0206528', 'cui_str': 'Gelatinases'}, {'cui': 'C1956074', 'cui_str': 'Lipocalins'}, {'cui': 'C0086589', 'cui_str': 'Surrogate Markers'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C2609414', 'cui_str': 'Acute Renal Injury'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0071744', 'cui_str': 'Cystatin 3'}]",,0.278511,"RESULTS


Median peak change of urinary neutrophil gelatinase-associated lipocalin was lower in the rhC1INH group (4.7 ng/ml vs. 22.5 ng/ml; p = 0.038) in the per-protocol population but not in the modified intention-to-treat analysis, and in patients with percutaneous coronary interventions (median, 1.8 ng/ml vs. 26.2 ng/ml; p = ","[{'ForeName': 'Anneza', 'Initials': 'A', 'LastName': 'Panagiotou', 'Affiliation': 'Division of Internal Medicine, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Marten', 'Initials': 'M', 'LastName': 'Trendelenburg', 'Affiliation': 'Division of Internal Medicine, University Hospital Basel, Basel, Switzerland; Department of Clinical Research and Department of Biomedicine, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Ingmar A F M', 'Initials': 'IAFM', 'LastName': 'Heijnen', 'Affiliation': 'Division of Medical Immunology, Laboratory Medicine, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Moser', 'Affiliation': 'Division of Internal Medicine, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Leo H', 'Initials': 'LH', 'LastName': 'Bonati', 'Affiliation': 'Division of Neurology and Stroke Center, Department of Clinical Research, University Hospital Basel and University of Basel, Basel Switzerland.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Breidthardt', 'Affiliation': 'Division of Internal Medicine, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Gregor', 'Initials': 'G', 'LastName': 'Fahrni', 'Affiliation': 'Department of Cardiology, University Hospital Basel and University of Basel, Basel, Switzerland.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Kaiser', 'Affiliation': 'Department of Cardiology, University Hospital Basel and University of Basel, Basel, Switzerland.'}, {'ForeName': 'Raban', 'Initials': 'R', 'LastName': 'Jeger', 'Affiliation': 'Department of Cardiology, University Hospital Basel and University of Basel, Basel, Switzerland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Osthoff', 'Affiliation': 'Division of Internal Medicine, University Hospital Basel, Basel, Switzerland; Department of Clinical Research and Department of Biomedicine, University of Basel, Basel, Switzerland. Electronic address: michael.osthoff@usb.ch.'}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2019.11.021']
354,30613000,Factors Associated With Efficacy of Cognitive Behavior Therapy vs Education for Patients With Irritable Bowel Syndrome.,"BACKGROUND & AIMS


Among patients with irritable bowel syndrome (IBS), it would be helpful to identify those most likely to respond to specific treatments, yet few factors have been identified that reliably predict positive outcome. We sought to identify pretreatment baseline characteristics that associate with gastrointestinal symptom improvement in patients who received empirically validated regimens of cognitive behavior therapy (CBT) or IBS education.
METHODS


We analyzed data from the IBS Outcome Study, in which 436 patients with IBS (average age, 41 years; 80%, female) were randomly assigned to groups that received 4 or 10 sessions of cognitive behavior therapy or education over 10 weeks. Baseline data were collected from all participants on sociodemographic and clinical features and comorbidities. Interaction analyses used a modified linear probability model with Huber-White robust estimators to identify baseline factors that moderated as a function of treatment condition GI symptom improvement based on the IBS-version of the Clinical Global Impressions-Improvement Scale.
RESULTS


Whether the primary outcome of IBS symptom improvement was rated by patients or physician assessors blind to treatment 2 weeks after it ended, higher percentages of patients had symptom improvement after CBT compared with EDU among those with low levels of trait anxiety (71.3% vs 34.9%; P < .05) or anxiety sensitivity (71.7% vs 38.6%; P < .05) and for those with baseline typical levels of trait anxiety (66.0% vs 47.1%; P < .05) or anxiety sensitivity (66.3% vs 47.1%; P < .05). For patients with high trait anxiety or anxiety sensitivity, the difference in percentage of responders to CBT vs EDU was non-significant for trait anxiety (60.6% vs 59.2%) and anxiety sensitivity (60.9% vs 55.9%). If patients scored at or below 22 on the Trait Anxiety Inventory, CBT had a statistically significant advantage over EDU. If patients scored at or below 29 on the Anxiety Sensitivity Inventory, there was a statistically significant advantage for CBT vs EDU.
CONCLUSIONS


In analyses of outcomes of patients with treatment-refractory IBS, baseline levels of trait anxiety and anxiety sensitivity (fear of arousal symptoms) were associated with improved gastrointestinal symptoms following CBT compared to IBS education. These findings and approaches might be used to optimize selection of treatment for patients with IBS.",2019,"If patients scored at or below 22 on the Trait Anxiety Inventory, CBT had a statistically significant advantage over EDU.","['patients who received empirically validated regimens of cognitive behavior therapy (CBT) or IBS education', 'patients with IBS', '436 patients with IBS (average age, 41\xa0years; 80%, female', 'patients with irritable bowel syndrome (IBS', 'Patients With Irritable Bowel\xa0Syndrome']","['cognitive behavior therapy or education over 10 weeks', 'Cognitive Behavior Therapy vs Education']","['trait anxiety', 'gastrointestinal symptoms', 'anxiety sensitivity', 'trait anxiety and anxiety sensitivity (fear of arousal symptoms', 'trait anxiety or anxiety sensitivity', 'IBS symptom improvement']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0022104', 'cui_str': 'Irritable Bowel Syndrome'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",436.0,0.0709497,"If patients scored at or below 22 on the Trait Anxiety Inventory, CBT had a statistically significant advantage over EDU.","[{'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Lackner', 'Affiliation': 'Divisions of Behavioral Medicine and Gastroenterology, Department of Medicine, Jacobs School of Medicine, University at Buffalo, Buffalo, New York. Electronic address: lackner@buffalo.edu.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Jaccard', 'Affiliation': 'School of Social Work, New York University, New York, New York.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2018.10.033']
355,31133672,Intermittent screening and treatment with dihydroartemisinin-piperaquine and intermittent preventive therapy with sulfadoxine-pyrimethamine have similar effects on malaria antibody in pregnant Malawian women.,"In a randomised trial comparing intermittent screening and treatment (IST) with dihydroartemisinin-piperaquine (DP) and intermittent preventive therapy against malaria in pregnancy (IPT) with sulfadoxine-pyrimethamine (SP) in Malawi, the impacts of IST-DP and IPT-SP on the development and maintenance of malaria antibody immunity were compared. Pregnant Malawian women were randomised to receive IST-DP or IPT-SP. In a nested study, paired enrolment and delivery plasma samples from 681 women were assayed for antibodies against recombinant antigens and for IgG and opsonising antibodies to antigens found on infected erythrocytes (IEs). At delivery, antibody responses did not differ between study arms. Between enrolment and delivery, antibodies to recombinant antigens decreased, whereas antibodies to IEs including opsonising antibodies remained stable. Overall, changes in antibody responses over pregnancy did not differ by treatment arm. Stratifying by gravidity, antibody to schizont extract decreased more in multigravidae receiving IST-DP than IPT-SP. There was minimal impact of treatment arm on the development and maintenance of malaria immunity. While antibodies to recombinant antigens declined between enrolment and delivery, antibodies directed against IEs tended to be more stable, suggesting longer-lasting protection.Clinical trial registration: Pa n African Clinical Trials Registry (PACTR201103000280319) 14/03/2011. URL: http://www.isrctn.com/ISRCTN69800930 .",2019,"Between enrolment and delivery, antibodies to recombinant antigens decreased, whereas antibodies to IEs including opsonising antibodies remained stable.","['Pregnant Malawian women', 'pregnant Malawian women', '681 women were assayed for antibodies against recombinant antigens and for IgG and opsonising antibodies to antigens found on infected erythrocytes (IEs']","['sulfadoxine-pyrimethamine', 'intermittent screening and treatment (IST) with dihydroartemisinin-piperaquine (DP', 'IST-DP or IPT-SP', 'dihydroartemisinin-piperaquine', 'sulfadoxine-pyrimethamine (SP']","['malaria antibody', 'antibody responses', 'antibody responses over pregnancy', 'development and maintenance of malaria immunity']","[{'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1510438', 'cui_str': 'Assay technique (qualifier value)'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0003320', 'cui_str': 'Antigens'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0014792', 'cui_str': 'Blood Corpuscles, Red'}]","[{'cui': 'C0700599', 'cui_str': 'Pyrimethamine / Sulfadoxine'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0058108', 'cui_str': 'quinghaosu, dihydro-'}, {'cui': 'C0071105', 'cui_str': ""Quinoline, 4,4'-(1,3-propanediyldi-4,1-piperazinediyl)bis(7-chloro-)""}, {'cui': 'C0380193', 'cui_str': 'iodine-123-IPT'}]","[{'cui': 'C0443723', 'cui_str': 'Malaria antibody (substance)'}, {'cui': 'C0003261', 'cui_str': 'Antibody Response'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0024530', 'cui_str': 'Plasmodium Infections'}, {'cui': 'C0020964', 'cui_str': 'Immunity'}]",681.0,0.0416564,"Between enrolment and delivery, antibodies to recombinant antigens decreased, whereas antibodies to IEs including opsonising antibodies remained stable.","[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Teo', 'Affiliation': 'Department of Medicine and Radiology and Doherty Institute, University of Melbourne, Melbourne, Victoria, Australia. andrew.teo@uqconnect.edu.au.'}, {'ForeName': 'Louise M', 'Initials': 'LM', 'LastName': 'Randall', 'Affiliation': 'Department of Medicine and Radiology and Doherty Institute, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Mwayiwawo', 'Initials': 'M', 'LastName': 'Madanitsa', 'Affiliation': 'College of Medicine, University of Malawi, Blantyre, Malawi.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Mwapasa', 'Affiliation': 'College of Medicine, University of Malawi, Blantyre, Malawi.'}, {'ForeName': 'Linda Kalilani', 'Initials': 'LK', 'LastName': 'Phiri', 'Affiliation': 'College of Medicine, University of Malawi, Blantyre, Malawi.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Khairallah', 'Affiliation': 'Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, United Kingdom.'}, {'ForeName': 'Christelle', 'Initials': 'C', 'LastName': 'Buffet', 'Affiliation': 'Department of Medicine and Radiology and Doherty Institute, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Amalia', 'Initials': 'A', 'LastName': 'Karahalios', 'Affiliation': 'Centre of Epidemiology and Biostatistics, Melbourne School of Population and Global Health, The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Narum', 'Affiliation': 'Laboratory of Malaria Immunology and Vaccinology, National Institute of Allergy and Infectious Diseases, National Institute of Health, Rockville, Maryland, USA.'}, {'ForeName': 'Feiko O Ter', 'Initials': 'FOT', 'LastName': 'Kuile', 'Affiliation': 'Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Rogerson', 'Affiliation': 'Department of Medicine and Radiology and Doherty Institute, University of Melbourne, Melbourne, Victoria, Australia. sroger@unimelb.edu.au.'}]",Scientific reports,['10.1038/s41598-019-44340-x']
356,31138860,Short-term changes in frequencies of circulating leukocytes associated with narrowband UVB phototherapy in people with clinically isolated syndrome.,"Clinically isolated syndrome (CIS) is the earliest clinical episode in multiple sclerosis (MS). Low environmental exposure to UV radiation is implicated in risk of developing MS, and therefore, narrowband UVB phototherapy might delay progression to MS in people with CIS. Twenty individuals with CIS were recruited, and half were randomised to receive 24 sessions of narrowband UVB phototherapy over a period of 8 weeks. Here, the effects of narrowband UVB phototherapy on the frequencies of circulating immune cells and immunoglobulin levels after phototherapy are reported. Peripheral blood samples for all participants were collected at baseline, and 1, 2, 3, 6 and 12 months after enrolment. An extensive panel of leukocyte populations, including subsets of T cells, B cells, monocytes, dendritic cells, and natural killer cells were examined in phototherapy-treated and control participants, and immunoglobulin levels measured in serum. There were significant short-term increases in the frequency of naïve B cells, intermediate monocytes, and fraction III FoxP3+ T regulatory cells, and decreases in switched memory B cells and classical monocytes in phototherapy-treated individuals. Since B cells are increasingly targeted by MS therapies, the effects of narrowband UVB phototherapy in people with MS should be investigated further.",2019,"There were significant short-term increases in the frequency of naïve B cells, intermediate monocytes, and fraction III FoxP3+ T regulatory cells, and decreases in switched memory B cells and classical monocytes in phototherapy-treated individuals.","['Twenty individuals with CIS', 'people with CIS', 'people with clinically isolated syndrome']",['narrowband UVB phototherapy'],"['frequencies of circulating immune cells and immunoglobulin levels', 'Peripheral blood samples', 'frequency of naïve B cells, intermediate monocytes, and fraction III FoxP3+ T regulatory cells, and decreases in switched memory B cells and classical monocytes', 'subsets of T cells, B cells, monocytes, dendritic cells, and natural killer cells']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C2921627', 'cui_str': 'Clinically isolated syndrome'}]","[{'cui': 'C3472306', 'cui_str': 'Narrowband ultraviolet B phototherapy (procedure)'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0428536', 'cui_str': 'Immunoglobulin level - finding'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood (substance)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0004561', 'cui_str': 'B-Cells'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0026473', 'cui_str': 'Monocytes'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C1267822', 'cui_str': 'T lymphocyte positive for both CD4 antigen and CD25 antigen'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0443177', 'cui_str': 'Classical (qualifier value)'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0011306', 'cui_str': 'Dendritic Cells'}, {'cui': 'C0022688', 'cui_str': 'NK Cells'}]",20.0,0.0579403,"There were significant short-term increases in the frequency of naïve B cells, intermediate monocytes, and fraction III FoxP3+ T regulatory cells, and decreases in switched memory B cells and classical monocytes in phototherapy-treated individuals.","[{'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Trend', 'Affiliation': 'Telethon Kids Institute, University of Western Australia, Perth, WA, Australia.'}, {'ForeName': 'Anderson P', 'Initials': 'AP', 'LastName': 'Jones', 'Affiliation': 'Telethon Kids Institute, University of Western Australia, Perth, WA, Australia.'}, {'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Cha', 'Affiliation': 'Telethon Kids Institute, University of Western Australia, Perth, WA, Australia.'}, {'ForeName': 'Matthew N', 'Initials': 'MN', 'LastName': 'Cooper', 'Affiliation': 'Telethon Kids Institute, University of Western Australia, Perth, WA, Australia.'}, {'ForeName': 'Sian', 'Initials': 'S', 'LastName': 'Geldenhuys', 'Affiliation': 'Telethon Kids Institute, University of Western Australia, Perth, WA, Australia.'}, {'ForeName': 'Marzena J', 'Initials': 'MJ', 'LastName': 'Fabis-Pedrini', 'Affiliation': 'Centre for Neuromuscular and Neurological Disorders, Perron Institute for Neurological and Translational Science, University of Western Australia, Sir Charles Gairdner Hospital, Perth, WA, Australia.'}, {'ForeName': 'William M', 'Initials': 'WM', 'LastName': 'Carroll', 'Affiliation': 'Centre for Neuromuscular and Neurological Disorders, Perron Institute for Neurological and Translational Science, University of Western Australia, Sir Charles Gairdner Hospital, Perth, WA, Australia.'}, {'ForeName': 'Judith M', 'Initials': 'JM', 'LastName': 'Cole', 'Affiliation': 'St John of God Dermatology Clinic, St John of God Hospital, Perth, WA, Australia.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Booth', 'Affiliation': 'University of Sydney, Faculty of Medicine and Health, Westmead Institute for Medical Research, Westmead, Australia.'}, {'ForeName': 'Robyn M', 'Initials': 'RM', 'LastName': 'Lucas', 'Affiliation': 'National Centre for Epidemiology & Population Health, Research School of Population Health, Australian National University, Canberra, ACT, Australia.'}, {'ForeName': 'Martyn A', 'Initials': 'MA', 'LastName': 'French', 'Affiliation': 'UWA Medical School and School of Biomedical Sciences, University of Western Australia, Perth, WA, Australia.'}, {'ForeName': 'Scott N', 'Initials': 'SN', 'LastName': 'Byrne', 'Affiliation': 'University of Sydney, Faculty of Medicine and Health, Westmead Institute for Medical Research, Westmead, Australia.'}, {'ForeName': 'Allan G', 'Initials': 'AG', 'LastName': 'Kermode', 'Affiliation': 'Centre for Neuromuscular and Neurological Disorders, Perron Institute for Neurological and Translational Science, University of Western Australia, Sir Charles Gairdner Hospital, Perth, WA, Australia.'}, {'ForeName': 'Prue H', 'Initials': 'PH', 'LastName': 'Hart', 'Affiliation': 'Telethon Kids Institute, University of Western Australia, Perth, WA, Australia. prue.hart@telethonkids.org.au.'}]",Scientific reports,['10.1038/s41598-019-44488-6']
357,31277077,Cardiorespiratory behavior of preterm infants receiving continuous positive airway pressure and high flow nasal cannula post extubation: randomized crossover study.,"BACKGROUND


Nasal continuous positive airway pressure (NCPAP) and high flow nasal cannula (HFNC) are modes of non-invasive respiratory support commonly used after extubation in extremely preterm infants. However, the cardiorespiratory physiology of these infants on each mode is unknown.
METHODS


Prospective, randomized crossover study in infants with birth weight ≤1250 g undergoing their first extubation attempt. NCPAP and HFNC were applied randomly for 45 min each, while ribcage and abdominal movements, electrocardiogram, oxygen saturation, and fraction of inspired oxygen (FiO 2 ) were recorded. Respiratory signals were analyzed using an automated method, and differences between NCPAP and HFNC features and changes in FiO 2  were analyzed.
RESULTS


A total of 30 infants with median [interquartile range] gestational age of 27 weeks [25.7, 27.9] and birth weight of 930 g [780, 1090] were studied. Infants were extubated at 5 days [2, 13] of life with 973 g [880, 1170] and three failed (10%). No differences in cardiorespiratory behavior were noted, except for longer respiratory pauses (9.2 s [5.0, 11.5] vs. 7.3 s [4.6, 9.3]; p = 0.04) and higher FiO 2  levels (p = 0.02) during HFNC compared to NCPAP.
CONCLUSIONS


In extremely preterm infants studied shortly after extubation, the use of HFNC was associated with longer respiratory pauses and higher FiO 2  requirements.",2020,"No differences in cardiorespiratory behavior were noted, except for longer respiratory pauses (9.2 s [5.0, 11.5] vs. 7.3 s [4.6, 9.3]; p = 0.04) and higher FiO 2  levels (p = 0.02) during HFNC compared to NCPAP.
","['extremely preterm infants', 'infants with birth weight ≤1250', 'preterm infants receiving continuous positive airway pressure and high flow nasal cannula post extubation', '30 infants with median [interquartile range] gestational age of 27 weeks [25.7, 27.9] and birth weight of 930\u2009g [780, 1090']","['HFNC', 'NCPAP and HFNC', 'Nasal continuous positive airway pressure (NCPAP) and high flow nasal cannula (HFNC']","['longer respiratory pauses', 'ribcage and abdominal movements, electrocardiogram, oxygen saturation, and fraction of inspired oxygen (FiO 2 ', 'cardiorespiratory behavior']","[{'cui': 'C3494262', 'cui_str': 'Extremely Preterm Infants'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannula'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0553891', 'cui_str': 'Tracheal Extubation'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C1258045', 'cui_str': 'Nasal Continuous Positive Airway Pressure'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannula'}]","[{'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0222762', 'cui_str': 'Thoracic Cage'}, {'cui': 'C1286159', 'cui_str': 'Movement of abdomen'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0428167', 'cui_str': 'FIO2'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",30.0,0.118465,"No differences in cardiorespiratory behavior were noted, except for longer respiratory pauses (9.2 s [5.0, 11.5] vs. 7.3 s [4.6, 9.3]; p = 0.04) and higher FiO 2  levels (p = 0.02) during HFNC compared to NCPAP.
","[{'ForeName': 'Lara J', 'Initials': 'LJ', 'LastName': 'Kanbar', 'Affiliation': 'Department of Biomedical Engineering, Montreal, QC, Canada.'}, {'ForeName': 'Wissam', 'Initials': 'W', 'LastName': 'Shalish', 'Affiliation': 'Department of Pediatrics, Neonatal Division, Montreal, QC, Canada.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Latremouille', 'Affiliation': 'Department of Pediatrics, Neonatal Division, Montreal, QC, Canada.'}, {'ForeName': 'Smita', 'Initials': 'S', 'LastName': 'Rao', 'Affiliation': 'Department of Pediatrics, Neonatal Division, Montreal, QC, Canada.'}, {'ForeName': 'Karen A', 'Initials': 'KA', 'LastName': 'Brown', 'Affiliation': 'Department of Anesthesia, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Kearney', 'Affiliation': 'Department of Biomedical Engineering, Montreal, QC, Canada.'}, {'ForeName': 'Guilherme M', 'Initials': 'GM', 'LastName': ""Sant'Anna"", 'Affiliation': 'Department of Pediatrics, Neonatal Division, Montreal, QC, Canada. guilherme.santanna@mcgill.ca.'}]",Pediatric research,['10.1038/s41390-019-0494-5']
358,32242905,Cost-effectiveness Analysis of the Elder-Friendly Approaches to the Surgical Environment (EASE) Intervention for Emergency Abdominal Surgical Care of Adults Aged 65 Years and Older.,"Importance


The Elder-Friendly Approaches to the Surgical Environment (EASE) initiative is a novel approach to acute surgical care for elderly patients.
Objective


To determine the cost-effectiveness of EASE.
Design, Setting, and Participants


An economic evaluation from the perspective of the health care system was conducted as part of the controlled before-and-after EASE study at 2 tertiary care centers, the University of Alberta Hospital and Foothills Medical Centre. Participants included elderly adults (aged ≥65 years) admitted for emergency abdominal surgery between 2014 and 2017. Data were analyzed from April 2018 to February 2019.
Main Outcomes and Measures


Data were captured at both control and intervention sites before and after implementation of the EASE intervention. Resource use was captured over 6 months of follow-up and was converted to costs. Utility was measured with the EuroQol Five-Dimensions Three-Levels instrument at 6 weeks and 6 months of follow-up. The differences-in-differences method was used to estimate the association of the intervention with cost and quality-adjusted life-years. For a subset of participants, self-reported out-of-pocket health care costs were collected using the Resource Use Inventory at 6 months.
Results


A total of 675 participants were included (mean [SD] age, 75.3 [7.9] years; 333 women [49.3%]), 289 in the intervention group and 386 in the control group. The mean (SD) cost per control participant was $36 995 ($44 169) before EASE and $35 032 ($43 611) after EASE (all costs are shown in 2018 Canadian dollars). The mean (SD) cost per intervention participant was $56 143 ($74 039) before EASE and $39 001 ($59 854) after EASE. Controlling for age, sex, and Clinical Frailty Score, the EASE intervention was associated with a mean (SE) cost reduction of 23.5% (12.5%) (P = .02). The change in quality-adjusted life-years observed associated with the intervention was not statistically significant (mean [SE], 0.00001 [0.0001] quality-adjusted life-year; P = .72). The Resource Use Inventory was collected for 331 participants. The mean (SE) odds ratio for having 0 out-of-pocket expenses because of the intervention, compared with having expenses greater than 0, was 15.77 (3.37) (P = .02). Among participants with Resource Use Inventory costs greater than 0, EASE was not associated with a change in spending (mean [SE] reduction associated with EASE, 19.1% [45.2%]; P = .57).
Conclusions and Relevance


This study suggests that the EASE intervention was associated with a reduction in costs and no change in quality-adjusted life-years. In locations that lack capacity to implement this intervention, costs to increase capacity should be weighed against the estimated costs avoided.",2020,"The change in quality-adjusted life-years observed associated with the intervention was not statistically significant (mean [SE], 0.00001","['elderly patients', '2 tertiary care centers, the University of Alberta Hospital and Foothills Medical Centre', 'Participants included elderly adults (aged ≥65 years) admitted for emergency abdominal surgery between 2014 and 2017', 'Adults', 'A total of 675 participants were included (mean [SD] age, 75.3 [7.9] years; 333 women [49.3%]), 289 in the intervention group and 386 in the control group', '331 participants', 'Aged 65 Years and Older']",[],"['mean (SD) cost per intervention participant', 'quality-adjusted life-years', 'mean (SE) odds ratio', 'mean (SD) cost per control participant']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0001914', 'cui_str': 'Alberta'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517854', 'cui_str': '675'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517724', 'cui_str': '333'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0580836', 'cui_str': 'Old'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",675.0,0.0279529,"The change in quality-adjusted life-years observed associated with the intervention was not statistically significant (mean [SE], 0.00001","[{'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Hofmeister', 'Affiliation': 'Department of Community Health Sciences, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Rachel G', 'Initials': 'RG', 'LastName': 'Khadaroo', 'Affiliation': 'Department of Surgery, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Jayna', 'Initials': 'J', 'LastName': 'Holroyd-Leduc', 'Affiliation': 'Department of Community Health Sciences, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Raj', 'Initials': 'R', 'LastName': 'Padwal', 'Affiliation': 'Department of Medicine, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Wagg', 'Affiliation': 'Department of Medicine, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Lindsey', 'Initials': 'L', 'LastName': 'Warkentin', 'Affiliation': 'Department of Surgery, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Clement', 'Affiliation': 'Department of Community Health Sciences, University of Calgary, Calgary, Alberta, Canada.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.2034']
359,32053417,Cardiorespiratory and metabolic responses to exercise testing during lower-body positive pressure running.,"Exercise reduces the future cardiometabolic disease risk. However, not everyone can participate in routine physical activity because of obesity or orthopedic impairments. Body weight-supported (BWS) exercise may be an option for these individuals. Unfortunately, very little data are available with regard to BWS running in untrained healthy individuals. Yet, this information is important to assess the potential use of lower-body positive pressure (LBPP) treadmill running for the prevention of cardiometabolic disease. Twenty healthy but untrained participants (10 females, mean age 31.5 yr) were included in this study. Participants completed two exercise tests (one with 100% and one with 60% body wt) in randomized order on a LBPP treadmill. Expired gas data and heart rate (HR) were collected continuously. Blood lactate, blood pressure (BP), pulse wave velocity (PWV), and rating of perceived exertion (RPE) were measured during a 2-min break after each stage. Oxygen uptake increased significantly independent of BWS but was lower with BWS. Furthermore, we identified a significant correlation between HR and RPE independent of BWS. BP and PWV showed a large heterogeneity in response to BWS. The lower O 2  requirement when running with BWS may help untrained individuals to adapt to an exercise regimen. Future research needs to explore the heterogenetic response of blood pressure and pulse wave velocity to LBPP BWS between individuals. NEW & NOTEWORTHY  Lower-body positive pressure body weight-supported exercise has a lower metabolic and cardiovascular demand. Furthermore, heart rate and rating of perceived exertion are highly correlated independent of body weight support. Our data support the further examination of lower-body positive pressure exercise training for cardiovascular disease risk groups.",2020,"RESULTS


Oxygen consumption (VO 2 ) increased significantly independent of BWS, but was lower with BWS.","['untrained healthy individuals', 'Twenty healthy but untrained subjects (ten females, mean age 31.5 years']","['LBPP treadmill', 'Body weight supported (BWS) exercise']","['BP and PWV', 'Expired gas data and heart rate (HR', 'Blood lactate (La), blood pressure (BP), pulse wave velocity (PWV) and rating of perceived exertion (RPE', 'Oxygen consumption', 'HR and RPE independent of BWS']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0596601', 'cui_str': 'Gas'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0005768'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}, {'cui': 'C0445208', 'cui_str': 'RPE'}, {'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}, {'cui': 'C0332291', 'cui_str': 'Independent of (attribute)'}]",,0.0507102,"RESULTS


Oxygen consumption (VO 2 ) increased significantly independent of BWS, but was lower with BWS.","[{'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Brüssau', 'Affiliation': 'Department of Internal Medicine B, University Medicine Greifswald, Greifswald, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Oehring', 'Affiliation': 'Department of Internal Medicine B, University Medicine Greifswald, Greifswald, Germany.'}, {'ForeName': 'Stephan B', 'Initials': 'SB', 'LastName': 'Felix', 'Affiliation': 'Department of Internal Medicine B, University Medicine Greifswald, Greifswald, Germany.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Dörr', 'Affiliation': 'Department of Internal Medicine B, University Medicine Greifswald, Greifswald, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Bahls', 'Affiliation': 'Department of Internal Medicine B, University Medicine Greifswald, Greifswald, Germany.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00328.2019']
360,32273094,1-Year Clinical Outcomes of All Comers Treated With 2 Bioresorbable Polymer-Coated Sirolimus-Eluting Stents: Propensity Score-Matched Comparison of the COMBO and Ultrathin-Strut Orsiro Stents.,"OBJECTIVES


The aim of this study was to determine 1-year safety and efficacy after treatment with the COMBO and Orsiro stents.
BACKGROUND


The COMBO stainless-steel stent has an anti-CD34 +  antibody coating to capture endothelial progenitor cells, thereby promoting faster endothelialization. The Orsiro is an ultrathin-strut cobalt-chromium stent, covered by an extremely thin layer of amorphous silicon carbide to minimize ion leakage. Both devices elute sirolimus from biodegradable polymers.
METHODS


For this analysis we included European patients from the COMBO collaboration, a patient-level pooling of 2 prospective all-comers registries of COMBO stent implantation (n = 2,775), and all patients randomized to the Orsiro stent (n = 1,169) from the Dutch BIO-RESORT (Comparison of Biodegradable Polymer and Durable Polymer Drug-Eluting Stents in an All Comers Population) randomized trial. The main outcome of interest was 1-year target lesion failure, a composite of cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization evaluated using propensity score-matched analysis.
RESULTS


At baseline, COMBO patients were older and had more insulin-treated diabetes, renal insufficiency, and other comorbidities. However, Orsiro patients included more current smokers and more acute coronary syndrome presentations. Orsiro patients also received longer stents and had more complex target lesions. After propensity score-matched analysis (n = 862/arm), 1-year target lesion failure occurred in 4.1% of COMBO-treated and 2.7% of Orsiro-treated patients (hazard ratio: 1.55; 95% confidence interval: 0.92 to 2.62; p = 0.10). Definite stent thrombosis occurred in 0.5% of COMBO-treated and 0.5% of Orsiro-treated patients (p = 0.99).
CONCLUSIONS


A propensity score-matched comparison of all comers treated with the COMBO or Orsiro stent showed no statistically significant differences. Stent thrombosis risk was low and similar between the stents. (Comparison of Biodegradable Polymer and Durable Polymer Drug-Eluting Stents in an All Comers Population [BIO-RESORT], NCT01674803; MASCOT-Post Marketing Registry [MASCOT], NCT02183454; Prospective Registry to Assess the Long-term Safety and Performance of the Combo Stent [REMEDEE Reg], NCT01874002).",2020,A propensity score-matched comparison of all comers treated with the COMBO or Orsiro stent showed no statistically significant differences.,"['European patients from the COMBO collaboration, a patient-level pooling of 2\xa0prospective all-comers registries of']","['2 Bioresorbable Polymer-Coated Sirolimus-Eluting Stents', 'COMBO and Orsiro stents', 'COMBO or Orsiro stent', 'COMBO stent implantation', 'Orsiro stent (n\xa0=\xa01,169) from the Dutch BIO-RESORT (Comparison of Biodegradable Polymer and Durable Polymer Drug-Eluting Stents', 'Biodegradable Polymer and Durable Polymer Drug-Eluting Stents']","['Stent thrombosis risk', '1-year target lesion failure, a composite of cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization evaluated using propensity score-matched analysis', '1-year target lesion failure', 'complex target lesions', 'Definite stent thrombosis', '1-year safety and efficacy', 'acute coronary syndrome presentations']","[{'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0034975', 'cui_str': 'Registries'}]","[{'cui': 'C0032521', 'cui_str': 'Polymer'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}]","[{'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0449618', 'cui_str': 'Target vessel'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C2718044', 'cui_str': 'Propensity Score'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0439544', 'cui_str': 'Definite'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}]",,0.121937,A propensity score-matched comparison of all comers treated with the COMBO or Orsiro stent showed no statistically significant differences.,"[{'ForeName': 'Jaya', 'Initials': 'J', 'LastName': 'Chandrasekhar', 'Affiliation': 'Icahn School of Medicine at Mount Sinai Hospital, New York, New York; Amsterdam UMC, Heart Center, and Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands.'}, {'ForeName': 'Marlies M', 'Initials': 'MM', 'LastName': 'Kok', 'Affiliation': 'Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands.'}, {'ForeName': 'Deborah N', 'Initials': 'DN', 'LastName': 'Kalkman', 'Affiliation': 'Icahn School of Medicine at Mount Sinai Hospital, New York, New York; Amsterdam UMC, Heart Center, and Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands.'}, {'ForeName': 'Melissa B', 'Initials': 'MB', 'LastName': 'Aquino', 'Affiliation': 'Icahn School of Medicine at Mount Sinai Hospital, New York, New York.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Zocca', 'Affiliation': 'Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands.'}, {'ForeName': 'Pier', 'Initials': 'P', 'LastName': 'Woudstra', 'Affiliation': 'Amsterdam UMC, Heart Center, and Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands.'}, {'ForeName': 'Marcel A', 'Initials': 'MA', 'LastName': 'Beijk', 'Affiliation': 'Amsterdam UMC, Heart Center, and Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands.'}, {'ForeName': 'Laura S', 'Initials': 'LS', 'LastName': 'Kerkmeijer', 'Affiliation': 'Amsterdam UMC, Heart Center, and Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Sartori', 'Affiliation': 'Icahn School of Medicine at Mount Sinai Hospital, New York, New York.'}, {'ForeName': 'Usman', 'Initials': 'U', 'LastName': 'Baber', 'Affiliation': 'Icahn School of Medicine at Mount Sinai Hospital, New York, New York.'}, {'ForeName': 'Jan G', 'Initials': 'JG', 'LastName': 'Tijssen', 'Affiliation': 'Amsterdam UMC, Heart Center, and Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands.'}, {'ForeName': 'Karel T', 'Initials': 'KT', 'LastName': 'Koch', 'Affiliation': 'Amsterdam UMC, Heart Center, and Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands.'}, {'ForeName': 'George D', 'Initials': 'GD', 'LastName': 'Dangas', 'Affiliation': 'Icahn School of Medicine at Mount Sinai Hospital, New York, New York.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Colombo', 'Affiliation': 'San Raffaele Hospital, Milan, Italy.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Pocock', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'von Birgelen', 'Affiliation': 'Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands.'}, {'ForeName': 'Roxana', 'Initials': 'R', 'LastName': 'Mehran', 'Affiliation': 'Icahn School of Medicine at Mount Sinai Hospital, New York, New York. Electronic address: roxana.mehran@mountsinai.org.'}, {'ForeName': 'Robbert J', 'Initials': 'RJ', 'LastName': 'de Winter', 'Affiliation': 'Amsterdam UMC, Heart Center, and Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2019.11.023']
361,32032196,"Prospective, Randomized Study on the Use of Prosthetic Mesh to Prevent a Parastomal Hernia in a Permanent Colostomy: Results of a Long-term Follow-up.","BACKGROUND


Parastomal hernias are common with permanent colostomies and prone to complications. The short-term results of trials of parastomal hernia prevention are widely published, but long-term results are scarce.
OBJECTIVE


The aim of the study is to detect the long-term effects and safety of preventive intra-abdominal parastomal mesh.
DESIGN


This is a long-term follow-up of a previous prospective randomized, controlled multicenter trial.
SETTINGS


This study was conducted at 2 university hospitals and 3 central hospitals in Finland.
PATIENTS


Patients who had a laparoscopic abdominoperineal resection for rectal cancer between 2010 and 2013 were included in the study and invited for a follow-up visit.
MAIN OUTCOME MEASURES


The primary outcomes measured were clinical and radiological parastomal hernias.
RESULTS


Twenty subjects in the mesh group and 15 in the control group attended the follow-up visit with a median follow-up period of 65 (25th-75th percentiles, 49-91) months. A clinically detectable parastomal hernia was present in 4 of 20 (20.0%) and 5 of 15 (33.3%) subjects in the mesh and control groups (p = 0.45). A radiological parastomal hernia was present in 9 of 19 (45.0%) subjects in the mesh group and 7 of 12 (58.3%) subjects in the control group (p = 0.72). However, when all subjects (n = 70, 1:1) who attended the 12-month follow-up were screened for long-term results according to register data, 9 of 35 (25.9%) subjects in the mesh group and 16 of 35 (45.6%) subjects in control group were diagnosed with a parastomal hernia during the follow-up period (p = 0.10). In addition, only 1 of 35 (2.7%) subjects in the mesh group but 6 of 35 (17.1%) subjects in the control group underwent a parastomal hernia operation during the long-term follow-up (p = 0.030).
LIMITATIONS


The study is limited by the small number of patients.
CONCLUSION


Prophylactic intra-abdominal keyhole mesh did not decrease the rate of clinically detectable hernias but reduced the need for the surgical repair of parastomal hernias. Further trials are needed to identify a more efficient method to prevent parastomal hernias. See Video Abstract at http://links.lww.com/DCR/B171.
CLINICAL TRIAL REGISTRATION


https://clinicaltrials.gov. Identifier: NCT02368873. ESTUDIO PROSPECTIVO ALEATORIZADO SOBRE EL USO DE MALLA PROTÉSICA PARA PREVENIR UNA HERNIA PARAESTOMAL EN UNA COLOSTOMÍA PERMANENTE: RESULTADOS DE UN SEGUIMIENTO A LARGO PLAZO: PREVENCIÓN DE HERNIA PARAESTOMAL, NEOPLASIA COLORRECTAL/ANAL: Las hernias paraestomales son comunes con colostomías permanentes y son propensas a complicaciones. Los resultados a corto plazo de los ensayos sobre la prevención de la hernia parastomal se publican ampliamente, pero los resultados a largo plazo son escasos.El objetivo del estudio es detectar los efectos a largo plazo y la seguridad de la malla parastomal intraabdominal preventiva.Este es un seguimiento a largo plazo de un estudio aleatorizado prospectivo, controlado y multicentrico previo.Este estudio se realizó en dos hospitales universitarios y tres hospitales centrales en Finlandia.Los pacientes que se sometieron a una resección abdominoperineal laparoscópica por cáncer de recto 2010-2013 fueron incluidos en el estudio e invitados a una visita de seguimiento.Hernias parastomales clínicas y radiológicas.Veinte sujetos en el grupo de malla y 15 en el grupo control asistieron a la visita de seguimiento con una mediana de seguimiento de 65 meses (25-75 ° percentil 49-91). Una hernia paraestomal clínicamente detectable estuvo presente en 4/20 (20.0%) y 5/15 (33.3%) en los grupos de malla y control, respectivamente (p = 0.45). Una hernia parastomal radiológica estuvo presente en 9/19 (45.0%) en el grupo de malla y 7/12 (58.3%) en el grupo de control (p = 0.72). Sin embargo, cuando todos los sujetos (n = 70, 1: 1) que asistieron a los 12 meses de seguimiento fueron evaluados para obtener resultados a largo plazo de acuerdo con los datos del registro, 9/35 (25.9%) sujetos en el grupo de malla y 16/35 (45,6%) sujetos en el grupo control fueron diagnosticados con una hernia paraestomal durante el período de seguimiento (p = 0,10). Además, solo 1/35 (2.7%) en el grupo de malla pero 6/35 (17.1%) en el grupo control se sometieron a una operación de hernia paraestomal durante el seguimiento a largo plazo (p = 0.030).El estudio está limitado por un pequeño número de pacientes.La malla intra-abdominal profiláctica en ojo de cerradura no disminuyó la tasa de hernias clínicamente detectables, pero redujo la necesidad de la reparación quirúrgica de las hernias paraestomales. Se necesitan ensayos adicionales para identificar un método más eficiente para prevenir las hernias parastomales. Vea el resumen del video en http://links.lww.com/DCR/B171. (Traducción-Dr. Gonzalo Hagerman).NCT02368873.",2020,A radiological parastomal hernia was present in 9/19 (45.0%) in the mesh group and 7/12 (58.3%) in the control group (p=0.72).,"['Patients who had a', 'two university hospitals and three central hospitals in Finland', 'for rectal cancer 2010-2013 were included in the study and invited for a follow-up visit']","['Prosthetic Mesh', 'laparoscopic abdominoperineal resection', 'preventive intra-abdominal parastomal mesh']","['parastomal hernia operation', 'Clinical and radiological parastomal hernias', 'radiological parastomal hernia', 'parastomal hernia', 'rate of clinically detectable hernias']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0016132', 'cui_str': 'Finland'}, {'cui': 'C0007113', 'cui_str': 'Cancer of Rectum'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0589121', 'cui_str': 'Follow-up visit (procedure)'}]","[{'cui': 'C0181805', 'cui_str': 'Mesh (physical object)'}, {'cui': 'C2004459', 'cui_str': 'Abdominoperineal Excision'}, {'cui': 'C1456501', 'cui_str': 'Preventive'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}]","[{'cui': 'C0341539', 'cui_str': 'Parastomal hernia (disorder)'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}]",,0.0316164,A radiological parastomal hernia was present in 9/19 (45.0%) in the mesh group and 7/12 (58.3%) in the control group (p=0.72).,"[{'ForeName': 'Elisa J', 'Initials': 'EJ', 'LastName': 'Mäkäräinen-Uhlbäck', 'Affiliation': 'Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Kai H B', 'Initials': 'KHB', 'LastName': 'Klintrup', 'Affiliation': 'Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Mika T', 'Initials': 'MT', 'LastName': 'Vierimaa', 'Affiliation': 'Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Monika A', 'Initials': 'MA', 'LastName': 'Carpelan-Holmström', 'Affiliation': 'Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Jyrki A O', 'Initials': 'JAO', 'LastName': 'Kössi', 'Affiliation': 'Päijät-Häme Central Hospital, Lahti, Finland.'}, {'ForeName': 'Matti V', 'Initials': 'MV', 'LastName': 'Kairaluoma', 'Affiliation': 'Jyväskylä Central Hospital, Jyväskylä, Finland.'}, {'ForeName': 'Pasi P', 'Initials': 'PP', 'LastName': 'Ohtonen', 'Affiliation': ''}, {'ForeName': 'Pirita R', 'Initials': 'PR', 'LastName': 'Tahvonen', 'Affiliation': 'Central Hospital of Lapland, Rovaniemi, Finland.'}, {'ForeName': 'Tero T', 'Initials': 'TT', 'LastName': 'Rautio', 'Affiliation': 'Oulu University Hospital, Oulu, Finland.'}]",Diseases of the colon and rectum,['10.1097/DCR.0000000000001599']
362,32259266,Effectiveness of Iodophor vs Chlorhexidine Solutions for Surgical Site Infections and Unplanned Reoperations for Patients Who Underwent Fracture Repair: The PREP-IT Master Protocol.,"Importance


The risk of developing a surgical site infection after extremity fracture repair is nearly 5 times greater than in most elective orthopedic surgical procedures. For all surgical procedures, it is standard practice to prepare the operative site with an antiseptic solution; however, there is limited evidence to guide the choice of solution used for orthopedic fracture repair.
Objective


To compare the effectiveness of iodophor vs chlorhexidine solutions to reduce surgical site infections and unplanned fracture-related reoperations for patients who underwent fracture repair.
Design, Setting, and Participants


The PREP-IT (Program of Randomized Trials to Evaluate Pre-operative Antiseptic Skin Solutions in Orthopaedic Trauma) master protocol will be followed to conduct 2 multicenter pragmatic cluster randomized crossover trials, Aqueous-PREP (Pragmatic Randomized Trial Evaluating Pre-Operative Aqueous Antiseptic Skin Solution in Open Fractures) and PREPARE (Pragmatic Randomized Trial Evaluating Pre-Operative Alcohol Skin Solutions in Fractured Extremities). The Aqueous-PREP trial will compare 4% aqueous chlorhexidine vs 10% povidone-iodine for patients with open extremity fractures. The PREPARE trial will compare 2% chlorhexidine in 70% isopropyl alcohol vs 0.7% iodine povacrylex in 74% isopropyl alcohol for patients with open extremity fractures and patients with closed lower extremity or pelvic fractures. Both trials will share key aspects of study design and trial infrastructure. The studies will follow a pragmatic cluster randomized crossover design with alternating treatment periods of approximately 2 months. The primary outcome will be surgical site infection and the secondary outcome will be unplanned fracture-related reoperations within 12 months. The Aqueous-PREP trial will enroll a minimum of 1540 patients with open extremity fractures from at least 12 hospitals; PREPARE will enroll a minimum of 1540 patients with open extremity fractures and 6280 patients with closed lower extremity and pelvic fractures from at least 18 hospitals. The primary analyses will adhere to the intention-to-treat principle and account for potential between-cluster and between-period variability. The patient-centered design, implementation, and dissemination of results are guided by a multidisciplinary team that includes 3 patients and other relevant stakeholders.
Discussion


The PREP-IT master protocol increases efficiency through shared trial infrastructure and study design components. Because prophylactic skin antisepsis is used prior to all surgical procedures and the application, cost, and availability of all study solutions are similar, the results of the PREP-IT trials are poised to inform clinical guidelines and bring about an immediate change in clinical practice.
Trial Registration


ClinicalTrials.gov Identifiers: NCT03385304 and NCT03523962.",2020,"To compare the effectiveness of iodophor vs chlorhexidine solutions to reduce surgical site infections and unplanned fracture-related reoperations for patients who underwent fracture repair.
","['patients who underwent fracture repair', '1540 patients with open extremity fractures from at least 12 hospitals', 'patients with open extremity fractures and patients with closed lower extremity or pelvic fractures', 'patients with open extremity fractures', '1540 patients with open extremity fractures and 6280 patients with closed lower extremity and pelvic fractures from at least 18 hospitals', 'Patients', 'Open Fractures', 'Fractured Extremities']","['Pre-Operative Aqueous Antiseptic Skin Solution', 'isopropyl alcohol', 'chlorhexidine', 'Fracture Repair', 'Iodophor vs Chlorhexidine Solutions', 'iodophor vs chlorhexidine solutions', 'isopropyl alcohol vs 0.7% iodine povacrylex', 'povidone-iodine']","['surgical site infection', 'unplanned fracture-related reoperations', 'surgical site infections and unplanned fracture-related reoperations', 'Surgical Site Infections and Unplanned Reoperations']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3805218', 'cui_str': 'Fracture repair'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0149531', 'cui_str': 'Fracture of pelvis'}, {'cui': 'C0016662', 'cui_str': 'Fracture, open'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0003205', 'cui_str': 'Antiseptic agent'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0022237', 'cui_str': 'Isopropyl Alcohol'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C3805218', 'cui_str': 'Fracture repair'}, {'cui': 'C0021988', 'cui_str': 'Iodophors'}, {'cui': 'C4517474', 'cui_str': '0.7'}, {'cui': 'C1876049', 'cui_str': 'iodine povacrylex'}, {'cui': 'C0032857', 'cui_str': 'Povidone-Iodine'}]","[{'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}]",6280.0,0.141164,"To compare the effectiveness of iodophor vs chlorhexidine solutions to reduce surgical site infections and unplanned fracture-related reoperations for patients who underwent fracture repair.
","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Gerard P', 'Initials': 'GP', 'LastName': 'Slobogean', 'Affiliation': 'Department of Orthopaedics, University of Maryland School of Medicine, Baltimore.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Sprague', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Wells', 'Affiliation': 'Trauma Survivors Network, Falls Church, Virginia.'}, {'ForeName': 'Mohit', 'Initials': 'M', 'LastName': 'Bhandari', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Alejandra', 'Initials': 'A', 'LastName': 'Rojas', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Alisha', 'Initials': 'A', 'LastName': 'Garibaldi', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Amber', 'Initials': 'A', 'LastName': 'Wood', 'Affiliation': 'Association of periOperative Registered Nurses, Denver, Colorado.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Howe', 'Affiliation': 'Department of Orthopaedics, University of Maryland School of Medicine, Baltimore.'}, {'ForeName': 'Anthony D', 'Initials': 'AD', 'LastName': 'Harris', 'Affiliation': 'Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore.'}, {'ForeName': 'Bradley A', 'Initials': 'BA', 'LastName': 'Petrisor', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Daniel C', 'Initials': 'DC', 'LastName': 'Mullins', 'Affiliation': 'Department of Pharmaceutical Health Services Research, University of Maryland School of Pharmacy, Baltimore.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Pogorzelski', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Marvel', 'Affiliation': 'Patient Advisor, Baltimore, Maryland.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Heels-Ansdell', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Franca', 'Initials': 'F', 'LastName': 'Mossuto', 'Affiliation': 'Hamilton Health Science, Hamilton, Ontario, Canada.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Grissom', 'Affiliation': 'Trauma Survivor Network, Baltimore, Maryland.'}, {'ForeName': 'Gina', 'Initials': 'G', 'LastName': 'Del Fabbro', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Gordon H', 'Initials': 'GH', 'LastName': 'Guyatt', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Gregory J', 'Initials': 'GJ', 'LastName': 'Della Rocca', 'Affiliation': 'Department of Orthopaedic Surgery, University of Missouri, Columbia.'}, {'ForeName': 'Haley K', 'Initials': 'HK', 'LastName': 'Demyanovich', 'Affiliation': 'Department of Orthopaedics, University of Maryland School of Medicine, Baltimore.'}, {'ForeName': 'I Leah', 'Initials': 'IL', 'LastName': 'Gitajn', 'Affiliation': 'Department of Orthopaedics, Dartmouth University, Hanover, New Hampshire.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Palmer', 'Affiliation': 'Patient Advisor, Baltimore, Maryland.'}, {'ForeName': 'Jean-Claude', 'Initials': 'JC', 'LastName': ""D'Alleyrand"", 'Affiliation': 'Department of Orthopaedic Surgery, Walter Reed National Military Medical Center, Bethesda, Maryland.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Friedrich', 'Affiliation': 'Washington, DC.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Rivera', 'Affiliation': 'Department of Orthopaedic Surgery, San Antonio Military Medical Center, San Antonio, Texas.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Hebden', 'Affiliation': 'Department of Pharmaceutical Health Services Research, University of Maryland School of Pharmacy, Baltimore.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Rudnicki', 'Affiliation': 'Department of Orthopaedics, University of Maryland School of Medicine, Baltimore.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Fowler', 'Affiliation': 'Department of Orthopaedic Surgery, San Antonio Military Medical Center, San Antonio, Texas.'}, {'ForeName': 'Kyle J', 'Initials': 'KJ', 'LastName': 'Jeray', 'Affiliation': 'Department of Orthopaedic Surgery, Greenville Health System, Greenville, South Carolina.'}, {'ForeName': 'Lehana', 'Initials': 'L', 'LastName': 'Thabane', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Marchand', 'Affiliation': 'Department of Orthopaedic Surgery, University of Utah, Salt Lake City.'}, {'ForeName': 'Lyndsay M', 'Initials': 'LM', 'LastName': ""O'Hara"", 'Affiliation': 'Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore.'}, {'ForeName': 'Manjari G', 'Initials': 'MG', 'LastName': 'Joshi', 'Affiliation': 'Department of Medicine, University of Maryland School of Medicine, Baltimore.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Talbot', 'Affiliation': 'Canadian Armed Forces, Montreal, Qubec, Canada.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Camara', 'Affiliation': 'Department of Orthopaedics, University of Maryland School of Medicine, Baltimore.'}, {'ForeName': 'Olivia Paige', 'Initials': 'OP', 'LastName': 'Szasz', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Nathan N', 'Initials': 'NN', 'LastName': ""O'Hara"", 'Affiliation': 'Department of Orthopaedics, University of Maryland School of Medicine, Baltimore.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'McKay', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'P J', 'Initials': 'PJ', 'LastName': 'Devereaux', 'Affiliation': 'Department of Medicine, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Robert V', 'Initials': 'RV', 'LastName': ""O'Toole"", 'Affiliation': 'Department of Orthopaedics, University of Maryland School of Medicine, Baltimore.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Zura', 'Affiliation': 'Department of Orthopaedics, Louisiana State University Health, New Orleans.'}, {'ForeName': 'Saam', 'Initials': 'S', 'LastName': 'Morshed', 'Affiliation': 'Department of Orthopaedic Surgery, University of California, San Francisco.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Dodds', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Stephanie L', 'Initials': 'SL', 'LastName': 'Tanner', 'Affiliation': 'Department of Orthopaedic Surgery, Greenville Health System, Greenville, South Carolina.'}, {'ForeName': 'Taryn', 'Initials': 'T', 'LastName': 'Scott', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Uyen', 'Initials': 'U', 'LastName': 'Nguyen', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.2215']
363,30927124,Randomized controlled trial of hemostatic powder versus endoscopic clipping for non-variceal upper gastrointestinal bleeding.,"BACKGROUND AND AIMS


Despite advances in pharmacological and endoscopic management of non-variceal upper gastrointestinal bleeding (NVUGIB), mortality is still relevant. TC-325 (Hemospray-Cook Medical) is a mineral powder with adsorptive properties, designed for endoscopic hemostasis. There are still no comparative trials studying this new hemostatic modality. The objective of this research was to compare the use of TC-325 (associated with epinephrine injection) with the combined technique of endoscopic clipping and epinephrine injection for the treatment of patients with NVUGIB.
METHODS


We conducted a pilot randomized controlled trial with patients that presented NVUGIB with an actively bleeding lesion at the endoscopic evaluation. Patients were randomized either to the Hemospray or Hemoclip group. The randomization list was generated by a computer program and remained unknown throughout the entire trial. All patients underwent second-look endoscopy.
RESULTS


Thirty-nine patients were enrolled. Peptic ulcer was the most frequent etiology. Primary hemostasis was achieved in all Hemospray cases and in 90% of Hemoclip group (p = 0.487). Five patients in Hemospray group underwent an additional hemostatic procedure during second-look endoscopy, while no patient in the Hemoclip group needed it (p = 0.04). Rebleeding, emergency surgery and mortality rates were similar in both groups. No toxicity, allergy events, or gastrointestinal obstruction signs were observed in Hemospray group.
CONCLUSIONS


TC-325 presents similar hemostatic results when compared with conventional dual therapy for patients with NVUGIB. Hemospray's excellent primary hemostasis rate certifies it as a valuable tool in arduous situations of severe bleeding or difficult location site.",2020,Primary hemostasis was achieved in all Hemospray cases and in 90% of Hemoclip group (p = 0.487).,"['patients that presented NVUGIB with an actively bleeding lesion at the endoscopic evaluation', 'non-variceal upper gastrointestinal bleeding', 'patients with NVUGIB', 'Thirty-nine patients were enrolled']","['hemostatic powder versus endoscopic clipping', 'epinephrine injection', 'endoscopic clipping and epinephrine injection', 'TC-325', 'Hemospray or Hemoclip', 'additional hemostatic procedure']","['Peptic ulcer', 'Rebleeding, emergency surgery and mortality rates', 'Primary hemostasis', 'No toxicity, allergy events, or gastrointestinal obstruction signs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0041909', 'cui_str': 'Upper gastrointestinal hemorrhage (disorder)'}, {'cui': 'C3816447', 'cui_str': '39 (qualifier value)'}]","[{'cui': 'C0019120', 'cui_str': 'Hemostatics'}, {'cui': 'C0032861', 'cui_str': 'Powdered drug preparation'}, {'cui': 'C0175722', 'cui_str': 'Clip'}, {'cui': 'C4018859', 'cui_str': 'Epinephrine Injection'}, {'cui': 'C0185010', 'cui_str': 'Clipping'}, {'cui': 'C3661030', 'cui_str': 'TC-325'}, {'cui': 'C3659062', 'cui_str': 'hemospray'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}]","[{'cui': 'C0030920', 'cui_str': 'Gastroduodenal Ulcer'}, {'cui': 'C0175673', 'cui_str': 'Emergency (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0740166', 'cui_str': 'Haemostasis'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0002111', 'cui_str': 'Allergy Specialty'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C1963974', 'cui_str': 'Gastrointestinal obstruction (SMQ)'}, {'cui': 'C0311392', 'cui_str': 'Sign'}]",39.0,0.0860415,Primary hemostasis was achieved in all Hemospray cases and in 90% of Hemoclip group (p = 0.487).,"[{'ForeName': 'Felipe Iankelevich', 'Initials': 'FI', 'LastName': 'Baracat', 'Affiliation': 'Gastrointestinal Endoscopy Unit, Gastroenterology Department, University of Sao Paulo Medical School, Av. Dr. Enéas de Carvalho Aguiar, 255. Cerqueira César, São Paulo, 05403-000, Brazil. fibaracat@hotmail.com.'}, {'ForeName': 'Diogo Turiani Hourneaux', 'Initials': 'DTH', 'LastName': 'de Moura', 'Affiliation': 'Gastrointestinal Endoscopy Unit, Gastroenterology Department, University of Sao Paulo Medical School, Av. Dr. Enéas de Carvalho Aguiar, 255. Cerqueira César, São Paulo, 05403-000, Brazil.'}, {'ForeName': 'Vítor Ottoboni', 'Initials': 'VO', 'LastName': 'Brunaldi', 'Affiliation': 'Gastrointestinal Endoscopy Unit, Gastroenterology Department, University of Sao Paulo Medical School, Av. Dr. Enéas de Carvalho Aguiar, 255. Cerqueira César, São Paulo, 05403-000, Brazil.'}, {'ForeName': 'Caio Vinicius', 'Initials': 'CV', 'LastName': 'Tranquillini', 'Affiliation': 'Gastrointestinal Endoscopy Unit, Gastroenterology Department, University of Sao Paulo Medical School, Av. Dr. Enéas de Carvalho Aguiar, 255. Cerqueira César, São Paulo, 05403-000, Brazil.'}, {'ForeName': 'Renato', 'Initials': 'R', 'LastName': 'Baracat', 'Affiliation': 'Gastrointestinal Endoscopy Unit, Gastroenterology Department, University of Sao Paulo Medical School, Av. Dr. Enéas de Carvalho Aguiar, 255. Cerqueira César, São Paulo, 05403-000, Brazil.'}, {'ForeName': 'Paulo', 'Initials': 'P', 'LastName': 'Sakai', 'Affiliation': 'Gastrointestinal Endoscopy Unit, Gastroenterology Department, University of Sao Paulo Medical School, Av. Dr. Enéas de Carvalho Aguiar, 255. Cerqueira César, São Paulo, 05403-000, Brazil.'}, {'ForeName': 'Eduardo Guimarães Hourneaux', 'Initials': 'EGH', 'LastName': 'de Moura', 'Affiliation': 'Gastrointestinal Endoscopy Unit, Gastroenterology Department, University of Sao Paulo Medical School, Av. Dr. Enéas de Carvalho Aguiar, 255. Cerqueira César, São Paulo, 05403-000, Brazil.'}]",Surgical endoscopy,['10.1007/s00464-019-06769-z']
364,31222044,Randomised clinical trial of ferric citrate hydrate on anaemia management in haemodialysis patients with hyperphosphataemia: ASTRIO study.,"Ferric citrate hydrate (FC) is an iron-based phosphate binder approved for hyperphosphataemia in patients with chronic kidney disease. We conducted a randomised controlled trial to evaluate the effects of FC on anaemia management in haemodialysis patients with hyperphosphataemia. We 1:1 randomised 93 patients who were undergoing haemodialysis and being treated with non-iron-based phosphate binders and erythropoiesis-stimulating agents (ESA) to receive 24 weeks of FC or to continue their non-iron-based phosphate binders (control) in a multicentre, open-label, parallel-design. Phosphate level was controlled within target range (3.5-6.0 mg/dL). The primary endpoint was change in ESA dose from baseline to end of treatment. Secondary endpoints were changes in red blood cell, iron and mineral, and bone-related parameters. Compared with control, FC reduced ESA dose [mean change (SD), -1211.8 (3609.5) versus +1195 (6662.8) IU/week; P = 0.03] without significant differences in haemoglobin. FC decreased red blood cell distribution width (RDW) compared with control. While there were no changes in serum phosphate, FC reduced C-terminal fibroblast growth factor (FGF) 23 compared with control. The incidence of adverse events did not differ significantly between groups. Despite unchanged phosphate and haemoglobin levels, FC reduced ESA dose, RDW, and C-terminal FGF23 compared with control.",2019,"Despite unchanged phosphate and haemoglobin levels, FC reduced ESA dose, RDW, and C-terminal FGF23 compared with control.","['93 patients who were undergoing haemodialysis and being treated with non-iron-based phosphate binders and erythropoiesis-stimulating agents (ESA) to receive 24 weeks of', 'haemodialysis patients with hyperphosphataemia', 'patients with chronic kidney disease']","['FC or to continue their non-iron-based phosphate binders (control', 'ferric citrate hydrate', 'FC', 'Ferric citrate hydrate (FC']","['anaemia management', 'Phosphate level', 'phosphate and haemoglobin levels, FC reduced ESA dose, RDW, and C-terminal FGF23', 'changes in red blood cell, iron and mineral, and bone-related parameters', 'change in ESA dose', 'FC decreased red blood cell distribution width (RDW', 'serum phosphate, FC reduced C-terminal fibroblast growth factor (FGF', 'incidence of adverse events', 'haemoglobin']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1601799', 'cui_str': 'phosphate ion'}, {'cui': 'C0179302', 'cui_str': 'Binder'}, {'cui': 'C1959590', 'cui_str': 'Erythropoiesis Stimulating Agents'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0085681', 'cui_str': 'Hyperphosphatemias'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}]","[{'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1601799', 'cui_str': 'phosphate ion'}, {'cui': 'C0179302', 'cui_str': 'Binder'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4041572'}]","[{'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0523826', 'cui_str': 'Phosphate measurement (procedure)'}, {'cui': 'C1601799', 'cui_str': 'phosphate ion'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C3472649', 'cui_str': 'ESAS'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1277078', 'cui_str': 'Red blood cells, blood product'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0026162', 'cui_str': 'Minerals'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0487742', 'cui_str': 'Width (qualifier value)'}, {'cui': 'C0036820', 'cui_str': 'Serum phosphate'}, {'cui': 'C1829744', 'cui_str': 'Fibroblast growth factor, C-terminal'}, {'cui': 'C0016026', 'cui_str': 'DNA Synthesis Factor'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0512347,"Despite unchanged phosphate and haemoglobin levels, FC reduced ESA dose, RDW, and C-terminal FGF23 compared with control.","[{'ForeName': 'Keitaro', 'Initials': 'K', 'LastName': 'Yokoyama', 'Affiliation': 'Division of Nephrology and Hypertension, Department of Internal Medicine, Jikei University School of Medicine, Tokyo, Japan. keitaro@jikei.ac.jp.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Fukagawa', 'Affiliation': 'Division of Nephrology, Endocrinology and Metabolism, Tokai University School of Medicine, Kanagawa, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Akiba', 'Affiliation': 'Tokyo Next Medical & Hemodialysis Clinic, Tokyo, Japan.'}, {'ForeName': 'Masaaki', 'Initials': 'M', 'LastName': 'Nakayama', 'Affiliation': 'Tohoku University Hospital, Miyagi, Japan.'}, {'ForeName': 'Kyoko', 'Initials': 'K', 'LastName': 'Ito', 'Affiliation': 'Medical Affairs Department, Torii Pharmaceutical Co. Ltd., Tokyo, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Hanaki', 'Affiliation': 'Pharmaceutical Division, Japan Tobacco Inc., Tokyo, Japan.'}, {'ForeName': 'Myles', 'Initials': 'M', 'LastName': 'Wolf', 'Affiliation': 'Division of Nephrology, Department of Medicine, and Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Hirakata', 'Affiliation': 'Fukuoka Renal Clinic, Fukuoka, Japan.'}]",Scientific reports,['10.1038/s41598-019-45335-4']
365,31248950,"Efficacy and Safety of Esaxerenone (CS-3150) for the Treatment of Type 2 Diabetes with Microalbuminuria: A Randomized, Double-Blind, Placebo-Controlled, Phase II Trial.","BACKGROUND AND OBJECTIVES


The progression of kidney disease in some patients with type 2 diabetes mellitus may not be adequately suppressed by renin-angiotensin system inhibitors. Esaxerenone (CS-3150) is a nonsteroidal mineralocorticoid receptor blocker that has shown kidney protective effects in preclinical studies, and it is a potential add-on therapy to treat diabetic kidney disease. This phase 2 study evaluated the efficacy and safety of esaxerenone in Japanese patients with type 2 diabetes mellitus and microalbuminuria.
DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS


This multicenter, randomized, double-blind, placebo-controlled trial enrolled 365 hypertensive or normotensive patients with type 2 diabetes mellitus and microalbuminuria (urinary albumin-to-creatinine ratio ≥45 to <300 mg/g creatinine) treated with renin-angiotensin system inhibitor who had eGFR≥30 ml/min per 1.73 m 2 . Participants were randomized to receive 0.625, 1.25, 2.5, or 5 mg/d esaxerenone or placebo for 12 weeks. The primary end point was the change in urinary albumin-to-creatinine ratio from baseline to week 12 (with last observation carried forward).
RESULTS


Esaxerenone treatment at 1.25, 2.5, and 5 mg/d significantly reduced urinary albumin-to-creatinine ratio by the end of treatment (38%, 50%, and 56%, respectively) compared with placebo (7%; all  P <0.001). The urinary albumin-to-creatinine ratio remission rate (defined as urinary albumin-to-creatinine ratio <30 mg/g creatinine at the end of treatment and ≥30% decrease from baseline) was 21% in the 2.5- and 5-mg/d groups versus 3% for placebo (both  P <0.05). Adverse events occurred slightly more frequently with esaxerenone versus placebo, but the frequencies of drug-related adverse events and discontinuation rates were similar in the placebo and the 0.625-, 1.25-, and 2.5-mg/d groups. Drug-related adverse events and treatment discontinuations were marginally higher in the 5-mg/d group. The most common drug-related adverse event was hyperkalemia, which was dose proportional.
CONCLUSIONS


Adding esaxerenone at 1.25, 2.5, and 5 mg/d for 12 weeks to an ongoing renin-angiotensin system inhibitor significantly reduces urinary albumin-to-creatinine ratio in patients with type 2 diabetes mellitus and microalbuminuria.",2019,"Adverse events occurred slightly more frequently with esaxerenone versus placebo, but the frequencies of drug-related adverse events and discontinuation rates were similar in the placebo and the 0.625-, 1.25-, and 2.5-mg/d groups.","['patients with type 2 diabetes mellitus and microalbuminuria', 'patients with type 2 diabetes mellitus', 'Type 2 Diabetes with Microalbuminuria', '365 hypertensive or normotensive patients with type 2 diabetes mellitus and microalbuminuria (urinary albumin-to-creatinine ratio ≥45 to <300 mg/g creatinine) treated with renin-angiotensin system inhibitor who had eGFR≥30 ml/min per 1.73 m 2 ', 'Japanese patients with type 2 diabetes mellitus and microalbuminuria']","['placebo', 'esaxerenone', 'Placebo', 'esaxerenone or placebo', 'Esaxerenone (CS-3150']","['Adverse events', 'change in urinary albumin-to-creatinine ratio', 'progression of kidney disease', 'urinary albumin-to-creatinine ratio', 'efficacy and safety', 'urinary albumin-to-creatinine ratio remission rate (defined as urinary albumin-to-creatinine ratio', 'frequencies of drug-related adverse events and discontinuation rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0730345', 'cui_str': 'Microalbuminuria (finding)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C2712122', 'cui_str': 'Normal blood pressure (finding)'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C1300563', 'cui_str': 'ug/mg'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0035096'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4278755', 'cui_str': 'CS-3150'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0022658', 'cui_str': 'Kidney Diseases'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}]",365.0,0.455259,"Adverse events occurred slightly more frequently with esaxerenone versus placebo, but the frequencies of drug-related adverse events and discontinuation rates were similar in the placebo and the 0.625-, 1.25-, and 2.5-mg/d groups.","[{'ForeName': 'Sadayoshi', 'Initials': 'S', 'LastName': 'Ito', 'Affiliation': 'Division of Nephrology, Endocrinology and Vascular Medicine, Department of Medicine, Tohoku University School of Medicine, Sendai, Japan; db554@med.tohoku.ac.jp.'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Shikata', 'Affiliation': 'Center for Innovative Clinical Medicine, Okayama University Hospital, Okayama, Japan.'}, {'ForeName': 'Masaomi', 'Initials': 'M', 'LastName': 'Nangaku', 'Affiliation': 'Division of Nephrology and Endocrinology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan; and.'}, {'ForeName': 'Yasuyuki', 'Initials': 'Y', 'LastName': 'Okuda', 'Affiliation': 'Biostatistics and Data Management Department, and.'}, {'ForeName': 'Tomoko', 'Initials': 'T', 'LastName': 'Sawanobori', 'Affiliation': 'Clinical Development Department Daiichi-Sankyo Co., Ltd., Tokyo, Japan.'}]",Clinical journal of the American Society of Nephrology : CJASN,['10.2215/CJN.14751218']
366,32265500,Dasatinib vs. imatinib in patients with chronic myeloid leukemia in chronic phase (CML-CP) who have not achieved an optimal response to 3 months of imatinib therapy: the DASCERN randomized study.,"Early molecular response is associated with improved probability of deep molecular response and superior survival in patients with CML-CP. However, ~1 in 3 patients on first-line imatinib do not achieve this threshold. The phase 2b DASCERN trial (NCT01593254) assessed the outcome of early switch to dasatinib in patients with suboptimal response to first-line imatinib. Adult patients with CML-CP were randomized (2:1) to receive 100 mg dasatinib (n = 174) or continue imatinib at ≥400 mg (n = 86). The primary endpoint was the rate of major molecular response (MMR) at 12 months, which was 29% (dasatinib) and 13% (imatinib; P = 0.005). After ≥2 years of follow-up, 45 patients (52%) randomized to continue imatinib had crossed over to dasatinib. Considering treatment crossover, the 2-year cumulative MMR rate was 64% with dasatinib and 41% with imatinib (66% and 67%, respectively by intent-to-treat). Adverse events were consistent with the established safety profiles of both drugs. The results of this first prospective study support early monitoring of patients treated with first-line imatinib, and suggest that switching to dasatinib in cases of suboptimal response may offer clinical benefit. Further follow-up is needed to assess the long-term clinical benefit of early switching.",2020,"Considering treatment crossover, the 2-year cumulative MMR rate was 64% with dasatinib and 41% with imatinib (66% and 67%, respectively by intent-to-treat).","['patients with chronic myeloid leukemia in chronic phase (CML-CP) who have not achieved an optimal response to 3 months of imatinib therapy', 'patients with CML-CP', 'Adult patients with CML-CP', 'patients with suboptimal response to first-line imatinib']","['Dasatinib vs. imatinib', '100\u2009mg dasatinib (n\u2009=\u2009174) or continue imatinib']","['probability of deep molecular response and superior survival', '2-year cumulative MMR rate', 'Adverse events', 'rate of major molecular response (MMR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023473', 'cui_str': 'Chronic myeloid leukemia'}, {'cui': 'C0457343', 'cui_str': 'Chronic phase'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0935989', 'cui_str': 'imatinib'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205132', 'cui_str': 'Linear'}]","[{'cui': 'C1455147', 'cui_str': 'dasatinib'}, {'cui': 'C0935989', 'cui_str': 'imatinib'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4517604', 'cui_str': '174'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0006416', 'cui_str': 'Burma'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",,0.0336482,"Considering treatment crossover, the 2-year cumulative MMR rate was 64% with dasatinib and 41% with imatinib (66% and 67%, respectively by intent-to-treat).","[{'ForeName': 'Jorge E', 'Initials': 'JE', 'LastName': 'Cortes', 'Affiliation': 'Georgia Cancer Center, Augusta University, Augusta, GA, USA. jorge.cortes@augusta.edu.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Jiang', 'Affiliation': ""Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Jianxiang', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences, Tianjin, China.'}, {'ForeName': 'Jianyu', 'Initials': 'J', 'LastName': 'Weng', 'Affiliation': ""Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, Guangdong, China.""}, {'ForeName': 'Huanling', 'Initials': 'H', 'LastName': 'Zhu', 'Affiliation': 'West China Hospital of Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'Xiaoli', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Hochhaus', 'Affiliation': 'Universitätsklinikum Jena, Jena, Germany.'}, {'ForeName': 'Dong-Wook', 'Initials': 'DW', 'LastName': 'Kim', 'Affiliation': 'The Catholic University of Korea, Seoul, Republic of Korea.'}, {'ForeName': 'Jerald', 'Initials': 'J', 'LastName': 'Radich', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Savona', 'Affiliation': 'Vanderbilt-Ingram Cancer Center, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Martin-Regueira', 'Affiliation': 'Bristol Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Oumar', 'Initials': 'O', 'LastName': 'Sy', 'Affiliation': 'Bristol Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Renuka', 'Initials': 'R', 'LastName': 'Gurnani', 'Affiliation': 'Bristol Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Saglio', 'Affiliation': 'University of Turin, Turin, Italy.'}]",Leukemia,['10.1038/s41375-020-0805-1']
367,32035412,Physical Activity Intervention Effects on Sedentary Time in Spanish-Speaking Latinas.,"BACKGROUND


Latinas have high rates of sedentary behavior and related health disparities, but it is unknown if interventions to increase physical activity will also reduce sedentary time. The current study examined changes in objectively measured sedentary time among Latinas in a randomized controlled trial of a physical activity intervention.
METHODS


Spanish-speaking Latinas (N = 202) were randomized to an exercise or wellness group and wore an accelerometer at baseline, 6 months, and 12 months.
RESULTS


Participants were sedentary on an average of 8.86 hours per day (SD = 2.60) at baseline. The intervention group had significantly greater increases in sedentary time compared with the control group, with the intervention group engaging in 146 more minutes per week of sedentary time at 6 months and 254 minutes per week of sedentary time at 12 months than the control group (P = .02). The intervention effect on sedentary behavior remained after controlling for moderate to vigorous physical activity. Additionally, time spent in moderate to vigorous physical activity was positively associated with more sedentary time (P = .04).
CONCLUSION


An intervention to increase moderate to vigorous physical activity resulted in greater sedentary time, raising concerns regarding compensation and highlighting the need for interventions to address both physical activity and sedentary behavior to improve public health.",2020,"The intervention group had significantly greater increases in sedentary time compared with the control group, with the intervention group engaging in 146 more minutes per week of sedentary time at 6 months and 254 minutes per week of sedentary time at 12 months than the control group (P = .02).","['Sedentary Time in Spanish-Speaking Latinas', 'Spanish-speaking Latinas (N = 202']","['Physical Activity Intervention', 'physical activity intervention', 'exercise or wellness group and wore an accelerometer at baseline, 6 months, and 12 months']","['sedentary time', 'sedentary behavior', 'time spent in moderate to vigorous physical activity']","[{'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C3161473', 'cui_str': 'Spaniards (ethnic group)'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1532253', 'cui_str': 'Sedentary Behavior'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",202.0,0.0457501,"The intervention group had significantly greater increases in sedentary time compared with the control group, with the intervention group engaging in 146 more minutes per week of sedentary time at 6 months and 254 minutes per week of sedentary time at 12 months than the control group (P = .02).","[{'ForeName': 'Sheri J', 'Initials': 'SJ', 'LastName': 'Hartman', 'Affiliation': ''}, {'ForeName': 'Dori', 'Initials': 'D', 'LastName': 'Pekmezi', 'Affiliation': ''}, {'ForeName': 'Shira I', 'Initials': 'SI', 'LastName': 'Dunsiger', 'Affiliation': ''}, {'ForeName': 'Bess H', 'Initials': 'BH', 'LastName': 'Marcus', 'Affiliation': ''}]",Journal of physical activity & health,['10.1123/jpah.2019-0112']
368,31494028,A Pilot Randomized Controlled Trial of Outcomes Associated with Parent-Nurse Controlled Analgesia vs. Continuous Opioid Infusion in the Neonatal Intensive Care Unit.,"PURPOSE


Prospectively compare parent/nurse controlled analgesia (PNCA) to continuous opioid infusion (COI) in the post-operative neonatal intensive care unit (NICU) population.
DESIGN/METHODS


A randomized controlled trial compared neonates treated with morphine PNCA to those treated with morphine COI. The primary outcome was average opioid consumption up to 3 post-operative days. Secondary outcomes included 1) pain intensity, 2) adverse events that may be directly related to opioid consumption, and 3) parent and nurse satisfaction.
RESULTS


The sample consisted of 25 post-operative neonates and young infants randomized to either morphine PNCA (n = 16) or COI (n = 9). Groups differed significantly on daily opioid consumption, with the PNCA group receiving significantly less opioid (P = .02). Groups did not differ on average pain score or frequency of adverse events (P values > .05). Parents in both groups were satisfied with their infant's pain management and parents in the PNCA group were slightly more satisfied with their level of involvement (P = .03). Groups did not differ in nursing satisfaction.
CONCLUSIONS


PNCA may be an effective alternative to COI for pain management in the NICU population. This method may also substantially reduce opioid consumption, provide more individualized care, and improve parent satisfaction with their level of participation.
CLINICAL IMPLICATIONS


Patients in the NICU represent one of our most vulnerable patient populations. As nurses strive to provide safe and effective pain management, results of this study suggest PNCA may allow nurses to maintain their patients' comfort while providing less opioid and potentially improving parental perception of involvement.
STUDY TYPE


Treatment study.
LEVEL OF EVIDENCE


I.",2020,"Groups differed significantly on daily opioid consumption, with the PNCA group receiving significantly less opioid (P = .02).",['Neonatal Intensive Care Unit'],"['nurse controlled analgesia (PNCA', 'PNCA', 'morphine COI', 'Parent-Nurse Controlled Analgesia vs. Continuous Opioid Infusion', 'morphine PNCA', 'COI', 'continuous opioid infusion (COI']","['1) pain intensity, 2) adverse events that may be directly related to opioid consumption, and 3) parent and nurse satisfaction', 'average opioid consumption', 'daily opioid consumption', 'average pain score or frequency of adverse events']","[{'cui': 'C0021709', 'cui_str': 'Newborn ICU'}]","[{'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}]",25.0,0.132448,"Groups differed significantly on daily opioid consumption, with the PNCA group receiving significantly less opioid (P = .02).","[{'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Czarnecki', 'Affiliation': ""Jane B. Pettit Pain and Headache Center, Children's Hospital of Wisconsin, Milwaukee, Wisconsin. Electronic address: mczarnecki@chw.org.""}, {'ForeName': 'Keri', 'Initials': 'K', 'LastName': 'Hainsworth', 'Affiliation': ""Jane B. Pettit Pain and Headache Center, Children's Hospital of Wisconsin, Milwaukee, Wisconsin; Department of Anesthesiology, Medical College of Wisconsin, Milwaukee, Wisconsin.""}, {'ForeName': 'Pippa M', 'Initials': 'PM', 'LastName': 'Simpson', 'Affiliation': 'Division of Quantitative Health Sciences, Medical College of Wisconsin, Milwaukee, Wisconsin; Department of Pediatrics, Medical College of Wisconsin, Milwaukee, Wisconsin; Department of Surgery, Section of Pediatric Surgery, Medical College of Wisconsin, Milwaukee, Wisconsin.'}, {'ForeName': 'Marjorie J', 'Initials': 'MJ', 'LastName': 'Arca', 'Affiliation': 'Department of Pediatrics, Medical College of Wisconsin, Milwaukee, Wisconsin; Department of Surgery, Section of Pediatric Surgery, Medical College of Wisconsin, Milwaukee, Wisconsin.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Uhing', 'Affiliation': 'Department of Surgery, Section of Pediatric Surgery, Medical College of Wisconsin, Milwaukee, Wisconsin; Department of Pediatrics, Section of Neonatology, Medical College of Wisconsin, Milwaukee, Wisconsin.'}, {'ForeName': 'Liyun', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Division of Quantitative Health Sciences, Medical College of Wisconsin, Milwaukee, Wisconsin.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Grippe', 'Affiliation': ""Neonatal Intensive Care Unit, Children's Hospital of Wisconsin, Milwaukee, Wisconsin.""}, {'ForeName': 'Jaya', 'Initials': 'J', 'LastName': 'Varadarajan', 'Affiliation': 'Department of Anesthesiology, Medical College of Wisconsin, Milwaukee, Wisconsin.'}, {'ForeName': 'Lynn M', 'Initials': 'LM', 'LastName': 'Rusy', 'Affiliation': ""Jane B. Pettit Pain and Headache Center, Children's Hospital of Wisconsin, Milwaukee, Wisconsin; Department of Anesthesiology, Medical College of Wisconsin, Milwaukee, Wisconsin.""}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Firary', 'Affiliation': ""Department of Pharmacy, Children's Hospital of Wisconsin, Milwaukee, Wisconsin.""}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Weisman', 'Affiliation': ""Jane B. Pettit Pain and Headache Center, Children's Hospital of Wisconsin, Milwaukee, Wisconsin; Department of Anesthesiology, Medical College of Wisconsin, Milwaukee, Wisconsin; Department of Pediatrics, Medical College of Wisconsin, Milwaukee, Wisconsin.""}]",Pain management nursing : official journal of the American Society of Pain Management Nurses,['10.1016/j.pmn.2019.08.002']
369,31917874,Neonatal pain response to automatic lancet versus needle heel-prick blood sampling: A prospective randomized controlled clinical trial.,"BACKGROUND


Automatic lancets have been reported to be superior to manual lancets in terms of pain and treatment time. However, no studies have yet been published comparing automatic lancet and needle puncture heel-prick blood sampling. The objective of this study was to compare the pain response and efficiency between the automatic lancet and needle at the time of heel blood sampling. The design was a randomized controlled trial. The inclusion criteria for the participants were a birthweight of ≧1,500 g and a gestational age of ≧30 weeks.
METHODS


The study examined a total of 105 neonates who were randomized into an automatic lancet group (n = 53) and a needle group (n = 52). The parameters measured included blood collection time, number of calf squeezes, duration of audible crying, and the Neonatal Infant Pain Scale (NIPS) score. The main outcome measure was audible crying duration.
RESULTS


The duration of audible crying was significantly shorter in the automatic lancet group when compared to the needle group (median 3 s, interquartile range (IQR) 0-33 s vs median 39 s, IQR 5-91.5 s, P = 0.0023). The NIPS score at the time of puncture was significantly lower in the automatic lancet group than in the needle group (median 1, IQR 0-5 vs median 5, IQR 3-6, P = 0.0060). There was no significant difference in the blood collection time and the number of calf squeezes between the two groups. The automatic lancet was found to be less painful than the needle puncture in neonatal heel-prick blood sampling with no significant difference in blood sampling time.
CONCLUSION


The automatic lancet was found to be less painful than the needle puncture in neonatal heel-prick blood sampling with no significant difference in blood sampling time.",2020,"The NIPS score at the time of puncture was significantly lower in the automatic lancet group than in the needle group (median 1, [IQR 0-5] vs. median 5, [IQR 3-6, p=0.0060].","['≧1500 g and a gestational age of ≧30 weeks', 'Inclusion criteria were a birth weight', '105 neonates and randomized into the automatic lancet group (n=53) and the needle group (n=52']","['Needle Heel Prick Blood Sampling', 'Automatic Lancet vs']","['pain response and efficiency', 'audible crying duration', 'Neonatal Pain Response', 'duration of audible crying', 'NIPS score at the time of puncture', 'blood collection time and the number of calf squeezes', 'blood sampling time', 'blood collection time, number of calf squeezes, duration of audible crying and the Neonatal Infant Pain Scale (NIPS) score']","[{'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1292718', 'cui_str': 'Is a'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C0777169', 'cui_str': 'Lancet (physical object)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0398296', 'cui_str': 'Cannulation of vascular fistula, graft or prosthetic device (procedure)'}]","[{'cui': 'C0398296', 'cui_str': 'Cannulation of vascular fistula, graft or prosthetic device (procedure)'}, {'cui': 'C0018870', 'cui_str': 'Heel'}, {'cui': 'C0033119', 'cui_str': 'Puncture wound - injury (disorder)'}, {'cui': 'C0005834', 'cui_str': 'Blood Specimen Collection'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C0777169', 'cui_str': 'Lancet (physical object)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0010399', 'cui_str': 'Cryings'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0033119', 'cui_str': 'Puncture wound - injury (disorder)'}, {'cui': 'C0005768'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0413258', 'cui_str': 'Barotrauma of descent (disorder)'}, {'cui': 'C0005834', 'cui_str': 'Blood Specimen Collection'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}]",105.0,0.0422071,"The NIPS score at the time of puncture was significantly lower in the automatic lancet group than in the needle group (median 1, [IQR 0-5] vs. median 5, [IQR 3-6, p=0.0060].","[{'ForeName': 'Tatenobu', 'Initials': 'T', 'LastName': 'Goto', 'Affiliation': 'Division of Pediatrics, Yokkaichi Municipal Hospital, Yokkaichi, Mie, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Inoue', 'Affiliation': 'Division of Pediatrics, Yokkaichi Municipal Hospital, Yokkaichi, Mie, Japan.'}, {'ForeName': 'Chinami', 'Initials': 'C', 'LastName': 'Kamiya', 'Affiliation': 'Division of Pediatrics, Yokkaichi Municipal Hospital, Yokkaichi, Mie, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Kawabe', 'Affiliation': 'Division of Pediatrics, Yokkaichi Municipal Hospital, Yokkaichi, Mie, Japan.'}, {'ForeName': 'Machiko', 'Initials': 'M', 'LastName': 'Higuchi', 'Affiliation': 'Division of Pediatrics, Yokkaichi Municipal Hospital, Yokkaichi, Mie, Japan.'}, {'ForeName': 'Megumi', 'Initials': 'M', 'LastName': 'Suyama', 'Affiliation': 'Division of Pediatrics, Yokkaichi Municipal Hospital, Yokkaichi, Mie, Japan.'}, {'ForeName': 'Tomoki', 'Initials': 'T', 'LastName': 'Goto', 'Affiliation': 'Division of Pediatrics, Yokkaichi Municipal Hospital, Yokkaichi, Mie, Japan.'}, {'ForeName': 'Wakato', 'Initials': 'W', 'LastName': 'Koide', 'Affiliation': 'Division of Pediatrics, Yokkaichi Municipal Hospital, Yokkaichi, Mie, Japan.'}, {'ForeName': 'Kanemasa', 'Initials': 'K', 'LastName': 'Maki', 'Affiliation': 'Division of Pediatrics, Yokkaichi Municipal Hospital, Yokkaichi, Mie, Japan.'}, {'ForeName': 'Katsumi', 'Initials': 'K', 'LastName': 'Ushijima', 'Affiliation': 'Division of Pediatrics, Yokkaichi Municipal Hospital, Yokkaichi, Mie, Japan.'}, {'ForeName': 'Kyoko', 'Initials': 'K', 'LastName': 'Ban', 'Affiliation': 'Division of Pediatrics, Yokkaichi Municipal Hospital, Yokkaichi, Mie, Japan.'}, {'ForeName': 'Yasumasa', 'Initials': 'Y', 'LastName': 'Yamada', 'Affiliation': 'Department of Perinatal and Neonatal Medicine, Aichi Medical University Sciences, Nagakute, Aichi, Japan.'}]",Pediatrics international : official journal of the Japan Pediatric Society,['10.1111/ped.14142']
370,32124514,CALIBER: a phase II randomized feasibility trial of chemoablation with mitomycin-C vs surgical management in low-risk non-muscle-invasive bladder cancer.,"OBJECTIVES


To evaluate the activity of intravesical mitomycin-C (MMC) to ablate recurrent low-risk non-muscle-invasive bladder cancer (NMIBC) and assess whether it may enable patients to avoid surgical intervention for treatment of recurrence.
PATIENTS AND METHODS


CALIBER is a phase II feasibility study. Participants were randomized (2:1) to treatment with four once-weekly MMC 40-mg intravesical instillations (chemoablation arm) or to surgical management. The surgical group was included to assess the feasibility of randomization. The primary endpoint was complete response to intravesical MMC in the chemoablation arm at 3 months, reported with exact 95% confidence intervals (CIs). Secondary endpoints included time to subsequent recurrence, summarized by Kaplan-Meier methods.
RESULTS


Between February 2015 and August 2017, 82 patients with visual diagnosis of recurrent low-risk NMIBC were enrolled from 24 UK hospitals (chemoablation, n = 54; surgical management, n =28). The median follow-up was 24 months. Complete response at 3 months was 37.0% (20/54; 95% CI 24.3-51.3) with chemoablation and 80.8% (21/26; 95% CI 60.6-93.4) with surgical management. Amongst patients with complete response at 3 months, a similar proportion was recurrence-free by 12 months in both groups (84%). Amongst those with residual disease at 3 months, the 12-month recurrence-free proportion was lower in the surgical management group (40.0%) than in the chemoablation group (84%). Recruitment stopped early as chemoablation did not meet the prespecified threshold of 45% complete responses at 3 months.
CONCLUSION


Intravesical chemoablation in low-risk NMIBC is feasible and safe, but did not demonstrate sufficient response in the present trial. After chemoablation there may be a reduction in recurrence rate, even in non-responders, that is greater than with surgery alone. Further research is required to investigate the role and optimal schedule of neoadjuvant intravesical chemotherapy prior to surgery for NMIBC.",2020,"Intravesical chemoablation in low risk NMIBC is feasible and safe, but did not demonstrate sufficient response in this trial.","['Between February 2015 and August 2017', 'low risk non-muscle invasive bladder cancer', '82 patients with visual diagnosis of recurrent low risk NMIBC were enrolled from 24 UK hospitals (54 chemoablation, 28 surgical management']","['intravesical mitomycin C (MMC', 'mitomycin', 'MMC 40mg intravesical instillations (chemoablation arm) or surgical management']","['recurrence rate', 'Complete response', 'time to subsequent recurrence, summarised by Kaplan-Meier methods', '12-month recurrence-free proportion', 'complete response to intravesical MMC', 'recurrence-free']","[{'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C1827293', 'cui_str': 'Invasive bladder cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}]","[{'cui': 'C0442124', 'cui_str': 'Intravesical approach (qualifier value)'}, {'cui': 'C0002475', 'cui_str': 'Mitomycin'}, {'cui': 'C0021917', 'cui_str': 'Instillation, Bladder'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}]","[{'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0442124', 'cui_str': 'Intravesical approach (qualifier value)'}]",82.0,0.125464,"Intravesical chemoablation in low risk NMIBC is feasible and safe, but did not demonstrate sufficient response in this trial.","[{'ForeName': 'A Hugh', 'Initials': 'AH', 'LastName': 'Mostafid', 'Affiliation': 'Royal Surrey County Hospital NHS Foundation Trust, Guildford, UK.'}, {'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Porta', 'Affiliation': 'Institute of Cancer Research, London, UK.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Cresswell', 'Affiliation': 'South Tees Hospitals NHS Foundation Trust, Middlesbrough, UK.'}, {'ForeName': 'Thomas R L', 'Initials': 'TRL', 'LastName': 'Griffiths', 'Affiliation': 'University Hospitals of Leicester NHS Trust, Leicester, UK.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Kelly', 'Affiliation': 'University College London, London, UK.'}, {'ForeName': 'Steven R', 'Initials': 'SR', 'LastName': 'Penegar', 'Affiliation': 'Institute of Cancer Research, London, UK.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Davenport', 'Affiliation': 'Gloucestershire Hospitals NHS Foundation Trust, Cheltenham, UK.'}, {'ForeName': 'John S', 'Initials': 'JS', 'LastName': 'McGrath', 'Affiliation': 'Royal Devon and Exeter NHS Foundation Trust, Exeter, UK.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Campain', 'Affiliation': 'Royal Devon and Exeter NHS Foundation Trust, Exeter, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Cooke', 'Affiliation': 'Royal Wolverhampton Hospitals NHS Trust, Wolverhampton, UK.'}, {'ForeName': 'Shikohe', 'Initials': 'S', 'LastName': 'Masood', 'Affiliation': 'Medway NHS Foundation Trust, Gillingham, UK.'}, {'ForeName': 'Margaret A', 'Initials': 'MA', 'LastName': 'Knowles', 'Affiliation': 'University of Leeds, Leeds, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Feber', 'Affiliation': 'University College London, London, UK.'}, {'ForeName': 'Allen', 'Initials': 'A', 'LastName': 'Knight', 'Affiliation': 'Action Bladder Cancer UK, Gloucestershire, UK.'}, {'ForeName': 'James W F', 'Initials': 'JWF', 'LastName': 'Catto', 'Affiliation': 'University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Lewis', 'Affiliation': 'Institute of Cancer Research, London, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Hall', 'Affiliation': 'Institute of Cancer Research, London, UK.'}]",BJU international,['10.1111/bju.15038']
371,31118449,Effects of different ablation strategies on long-term left atrial function in patients with paroxysmal atrial fibrillation: a single-blind randomized controlled trial.,"Restoration of sinus rhythm in atrial fibrillation (AF) by radiofrequency catheter ablation (RFCA) is associated with a transient stunning of left atrial (LA) function. However, the long-term effects of different ablation strategies on LA function remain undetermined. We performed randomized controlled trial to evaluate the effects of RFCA, cryoablation, and 3D mapping-guided cryoablation on LA function of proximal AF patients within 1 year. The 3D mapping-guided cryoablation was defined as a maximum of two cryoablation procedures for each pulmonary vein accompanied by RFCA for additional points until complete pulmonary vein isolation was achieved. Conventional and speckle tracking echocardiographic analyses were performed to evaluate LA function. Among the 210 patients (70 in each group) included, a trend of decreasing LA systolic and diastolic function was observed in all groups, as evidenced by decreases in peak A-wave velocity, the global LA peak systolic strain, the peak strain rate, the peak early diastolic strain rate, and the peak late diastolic strain rate within 7 days to 3 months after ablation followed by gradual recovery thereafter. However, the temporal changes in the above four strain parameters among the three groups did not differ significantly within 1 year after ablation (all p > 0.05). Parameters of the LA emptying fraction and LA dimensions were not significantly affected. These results suggested that stunning of LA function occurred within 7 days to 3 months after ablation, and different strategies of AF ablation did not differentially affect the temporal changes in LA function up to 1 year after ablation.",2019,"However, the temporal changes in the above four strain parameters among the three groups did not differ significantly within 1 year after ablation (all p > 0.05).","['patients with paroxysmal atrial fibrillation', '210 patients (70 in each group', 'proximal AF patients within 1 year']","['radiofrequency catheter ablation (RFCA', 'RFCA, cryoablation, and 3D mapping-guided cryoablation']","['stunning of LA function', 'LA emptying fraction and LA dimensions', 'peak A-wave velocity, the global LA peak systolic strain, the peak strain rate, the peak early diastolic strain rate, and the peak late diastolic strain rate', 'LA function', 'LA systolic and diastolic function']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0235480', 'cui_str': 'Paroxysmal atrial fibrillation (disorder)'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0162561', 'cui_str': 'Catheter Ablation, Radiofrequency'}, {'cui': 'C0010408', 'cui_str': 'Cryoablation'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C2599617', 'cui_str': 'a wave (qualifier value)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0442710', 'cui_str': 'Peak systolic, function (observable entity)'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}]",210.0,0.0326991,"However, the temporal changes in the above four strain parameters among the three groups did not differ significantly within 1 year after ablation (all p > 0.05).","[{'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'You', 'Affiliation': ""Division of Cardiology, The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, People's Republic of China.""}, {'ForeName': 'Lixia', 'Initials': 'L', 'LastName': 'Yao', 'Affiliation': ""Division of Cardiology, The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, People's Republic of China.""}, {'ForeName': 'Bolun', 'Initials': 'B', 'LastName': 'Zhou', 'Affiliation': ""Xiangya School of Medicine, Central South University, Changsha, People's Republic of China.""}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Jin', 'Affiliation': ""Division of Cardiology, The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, People's Republic of China.""}, {'ForeName': 'Honglin', 'Initials': 'H', 'LastName': 'Yin', 'Affiliation': ""Division of Cardiology, The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, People's Republic of China.""}, {'ForeName': 'Jinglan', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': ""Division of Cardiology, The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, People's Republic of China.""}, {'ForeName': 'Guangli', 'Initials': 'G', 'LastName': 'Yin', 'Affiliation': ""Division of Cardiology, The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, People's Republic of China.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': ""Division of Cardiology, The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, People's Republic of China.""}, {'ForeName': 'Chenfeng', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': ""Division of Cardiology, The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, People's Republic of China.""}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Division of Cardiology, The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, People's Republic of China.""}, {'ForeName': 'Ruiqin', 'Initials': 'R', 'LastName': 'Xie', 'Affiliation': ""Division of Cardiology, The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, People's Republic of China. xieruiqin88@163.com.""}]",Scientific reports,['10.1038/s41598-019-44168-5']
372,31118458,Clinical effect of stannous fluoride and amine fluoride containing oral hygiene products: A 4-year randomized controlled pilot study.,"This 4-year randomized controlled trial (RCT) aimed at investigating whether routine home use of both a SnCl 2 /AmF/NaF-containing mouth rinse and toothpaste has a preventive effect on oral health. Fifty-four test subjects were examined in biannual intervals. The primary endpoint ""dental erosion"" was determined by the Basic Erosive Wear Examination (BEWE). The secondary endpoints were ""saliva pH"", ""dentin hypersensitivity"" generated by Visual Analogue Scale (VAS), and ""discoloration"" measured by the Lobene Stain Index (LSI). A mixed model for repeated measures (MMRM) was used to analyze the primary endpoint ""dental erosion"". Primary analysis showed a significant intervention effect of the SnCl 2 /AmF/NaF-containing test product (p 1  = 0.0242). This result was confirmed by two additional MMRM-based sensitivity analyses. Comparison of all models showed ""dental erosion"" values of the intervention group  below values of the control group. Discoloration of the teeth was significantly higher in the intervention than in the control group at all time points. Saliva pH and dentin hypersensitivity were not significantly different between groups over four years. In summary, this RCT is the first to indicate a possible preventive effect of SnCl 2 /AmF/NaF-containing oral hygiene products on dental erosion over a follow-up period of four years.",2019,Discoloration of the teeth was significantly higher in the intervention than in the control group at all time points.,[],"['SnCl 2 /AmF/NaF-containing mouth rinse and toothpaste', 'stannous fluoride and amine fluoride containing oral hygiene products']","['dental erosion', 'Discoloration of the teeth', 'Saliva pH and dentin hypersensitivity', 'saliva pH"", ""dentin hypersensitivity"" generated by Visual Analogue Scale (VAS), and ""discoloration"" measured by the Lobene Stain Index (LSI', 'Basic Erosive Wear Examination (BEWE', 'SnCl 2 /AmF/NaF-containing test product']",[],"[{'cui': 'C0075160', 'cui_str': 'stannous chloride'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0026647', 'cui_str': 'Oral Rinse'}, {'cui': 'C0040462', 'cui_str': 'Toothpaste'}, {'cui': 'C0038143', 'cui_str': 'Stannous Fluoride'}, {'cui': 'C0002508', 'cui_str': 'Amines'}, {'cui': 'C0016327', 'cui_str': 'Fluorides'}, {'cui': 'C1272386', 'cui_str': 'Mouth care management'}]","[{'cui': 'C4522313', 'cui_str': 'Dental (intended site)'}, {'cui': 'C0333307', 'cui_str': 'Superficial ulcer (morphologic abnormality)'}, {'cui': 'C0332572', 'cui_str': 'Abnormal color'}, {'cui': 'C0040426', 'cui_str': 'Tooth'}, {'cui': 'C0036087', 'cui_str': 'Saliva (substance)'}, {'cui': 'C0011432', 'cui_str': 'Tooth Sensitivity'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0487602', 'cui_str': 'Staining'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439679', 'cui_str': 'Erosive (qualifier value)'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C0075160', 'cui_str': 'stannous chloride'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",,0.0516369,Discoloration of the teeth was significantly higher in the intervention than in the control group at all time points.,"[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Frese', 'Affiliation': 'Department of Conservative Dentistry, Clinic for Oral, Dental and Maxillofacial Diseases, Dental School, University Hospital Heidelberg, Heidelberg, Germany. cornelia.frese@med.uni-heidelberg.de.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Wohlrab', 'Affiliation': 'Department of Conservative Dentistry, Clinic for Oral, Dental and Maxillofacial Diseases, Dental School, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Sheng', 'Affiliation': 'Institute of Medical Biometry and Informatics, Ruprecht Karls University, Heidelberg, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kieser', 'Affiliation': 'Institute of Medical Biometry and Informatics, Ruprecht Karls University, Heidelberg, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Krisam', 'Affiliation': 'Institute of Medical Biometry and Informatics, Ruprecht Karls University, Heidelberg, Germany.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Wolff', 'Affiliation': 'Department of Conservative Dentistry, Clinic for Oral, Dental and Maxillofacial Diseases, Dental School, University Hospital Tübingen, Tübingen, Germany.'}]",Scientific reports,['10.1038/s41598-019-44164-9']
373,31235709,"A comparison of a novel endoscopic ""Su-Wang technique"" with the open ""Jaboulay's procedure"" for the surgical treatment of adult primary vaginal hydrocele.","This paper was aimed to introduce and compare outcomes of a novel ""Su-Wang (S-W) technique"" for endoscopic treatment of adult hydrocele with conventional open hydrocelectomy with ""Jaboulay's (JA) procedure"" regarding adverse events (AEs) and patient satisfaction. In the randomized controlled trial, adult males with primary hydroceles were prospectively assigned into S-W or JA group. We recorded perioperative data and postoperative AEs (incision length, recurrence, hematoma, wound infection and edema vanished time). Finally, a total of 42 adult patients underwent the S-W (n = 22) or JA (n = 20) procedure. Procedures were successfully completed for all 42 patients. No significant differences were found between the two groups regarding age, symptom duration, body mass index, and size of the hydrocele. The incision length was significantly shorter in the S-W group (1.00 ± 0.24 cm) than in the JA group (6.10 ± 1.46 cm). After 6 months' follow-up, complete data of 90.5% (38/42) were obtained. Severe AEs did not occur in any patient. Recurrence, hematoma, wound infection, edema vanished time values, and satisfaction in the S-W group were superior to those in the JA group. All patients in the S-W group were satisfied with this novel procedure, particularly due to the minimally invasive incision. In conclusion, the novel ""S-W technique"" for hydrocelectomy provided satisfactory cosmetic results with a 1-cm scrotal incision only. With the near-complete excision of the parietal TV, it resulted in no recurrence, fewer AEs, and rapid postoperative rehabilitation in comparison to the traditional ""JA procedure."" The endoscopic ""S-W technique"" may be a viable alternative for the surgical treatment of adult primary vaginal hydrocele.",2019,"Recurrence, hematoma, wound infection, edema vanished time values, and satisfaction in the S-W group were superior to those in the JA group.","['adult hydrocele with conventional open hydrocelectomy with ""Jaboulay\'s (JA', '42 adult patients underwent the S-W (n\u2009=\u200922) or', 'adult males with primary hydroceles', 'adult primary vaginal hydrocele']","['JA', 'novel endoscopic ""Su-Wang technique"" with the open ""Jaboulay\'s procedure', 'novel ""Su-Wang (S-W) technique']","['Recurrence, hematoma, wound infection, edema vanished time values, and satisfaction', 'age, symptom duration, body mass index, and size of the hydrocele', 'perioperative data and postoperative AEs (incision length, recurrence, hematoma, wound infection and edema vanished time', 'incision length']","[{'cui': 'C3875182', 'cui_str': 'Adult hydrocele (disorder)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0194977', 'cui_str': 'Hydrocelectomy (procedure)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1720771', 'cui_str': 'Scrotal Hydrocele'}]","[{'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}]","[{'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0043241', 'cui_str': 'Wound Infection'}, {'cui': 'C0013604', 'cui_str': 'Hydrops'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C1720771', 'cui_str': 'Scrotal Hydrocele'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0184898', 'cui_str': 'Incision - attribute'}, {'cui': 'C1444754', 'cui_str': 'Length property'}]",42.0,0.0412537,"Recurrence, hematoma, wound infection, edema vanished time values, and satisfaction in the S-W group were superior to those in the JA group.","[{'ForeName': 'Junhao', 'Initials': 'J', 'LastName': 'Lei', 'Affiliation': 'Department of Urology, Zhongnan Hospital of Wuhan University, Wuhan University, Wuhan, 430071, China.'}, {'ForeName': 'Chunhua', 'Initials': 'C', 'LastName': 'Luo', 'Affiliation': 'Department of Urology, Zhongnan Hospital of Wuhan University, Wuhan University, Wuhan, 430071, China.'}, {'ForeName': 'Yangyang', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Urology, Zhongnan Hospital of Wuhan University, Wuhan University, Wuhan, 430071, China.'}, {'ForeName': 'Yuming', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Department of Urology, Zhongnan Hospital of Wuhan University, Wuhan University, Wuhan, 430071, China.'}, {'ForeName': 'Xinjun', 'Initials': 'X', 'LastName': 'Su', 'Affiliation': 'Department of Urology, Zhongnan Hospital of Wuhan University, Wuhan University, Wuhan, 430071, China. 13697326659@139.com.'}, {'ForeName': 'Xinghuan', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Urology, Zhongnan Hospital of Wuhan University, Wuhan University, Wuhan, 430071, China. wangxinghuan@whu.edu.cn.'}]",Scientific reports,['10.1038/s41598-019-45229-5']
374,31249332,Effects of Kinect-based exergaming on frailty status and physical performance in prefrail and frail elderly: A randomized controlled trial.,"Frailty status can be improved by intervention. Both exergaming and combined exercise have been proposed for improving physical performance in community-dwelling elderly. However, whether frailty status can be improved by exergaming is unclear. Moreover, whether Kinect-based exergaming training can exert a stronger effect on improving frailty status than combined exercise needs to be established. The aim of this study was to investigate the effects of Kinect-based exergaming on improving frailty status and physical performance in the prefrail and frail elderly by comparing its effects with those of combined exercise. Fifty-two prefrail and frail elderly were recruited and randomized to the Kinect-based exergaming group (EXER group) or combined exercise group (CE group), emphasizing resistance, aerobic, and balance training for 36 sessions over 12 weeks. Our results showed that both groups improved the frailty status (EXER group: p = 0.016, effect size = 2.29; and CE group: p = 0.031, effect size = 2.67). Three out of 5 physical characteristics of the frailty phenotype, namely, weakness, slow walking speed, and low activity level, were significantly reversed by both exergaming and combined exercise. However, the exergaming training also significantly reversed exhaustion. Furthermore, compared with the CE group, the EXER group showed greater improvement in dynamic balance control, as indicated by the forward reaching test (p = 0.0013, effect size = 0.40) and single leg stance test (p = 0.049, effect size = 0.42). Thus, Kinect-based exergaming exerted effects that were at least as beneficial as those of combined exercise in improving frailty status and the frailty phenotype. We recommend the use of exergaming aided by Kinect in the prefrail and frail elderly.",2019,"Our results showed that both groups improved the frailty status (EXER group: p = 0.016, effect size = 2.29; and CE group: p = 0.031, effect size = 2.67).","['community-dwelling elderly', 'Fifty-two prefrail and frail elderly', 'prefrail and frail elderly']","['Kinect-based exergaming training', 'combined exercise', 'Kinect-based exergaming group (EXER group) or combined exercise group (CE group), emphasizing resistance, aerobic, and balance training', 'CE', 'Kinect-based exergaming', 'exergaming and combined exercise', 'EXER']","['frailty status and physical performance', 'frailty phenotype, namely, weakness, slow walking speed, and low activity level', 'frailty status', 'single leg stance test', 'dynamic balance control', 'physical performance']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4319570', 'cui_str': 'Fifty-two'}, {'cui': 'C0079377', 'cui_str': 'Frail Elders'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}]","[{'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C2607857'}, {'cui': 'C1314763', 'cui_str': 'Phenotyping (qualifier value)'}, {'cui': 'C3714552', 'cui_str': 'Weakness - general'}, {'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",5.0,0.0353323,"Our results showed that both groups improved the frailty status (EXER group: p = 0.016, effect size = 2.29; and CE group: p = 0.031, effect size = 2.67).","[{'ForeName': 'Ying-Yi', 'Initials': 'YY', 'LastName': 'Liao', 'Affiliation': 'Department of Gerontological Health Care, National Taipei University of Nursing and Health Sciences, Taipei, Taiwan.'}, {'ForeName': 'I-Hsuan', 'Initials': 'IH', 'LastName': 'Chen', 'Affiliation': 'Department of Physical Therapy, Fooyin University, Kaohsiung, Taiwan.'}, {'ForeName': 'Ray-Yau', 'Initials': 'RY', 'LastName': 'Wang', 'Affiliation': 'Department of Physical Therapy and Assistive Technology, National Yang-Ming University, Taipei, Taiwan. rywang@ym.edu.tw.'}]",Scientific reports,['10.1038/s41598-019-45767-y']
375,32237004,What have we learnt about asthma control from trials of budesonide/formoterol as maintenance and reliever?,"Despite improvements in medications, devices and understanding of the disease, about half of all asthma patients worldwide remain inadequately controlled, suggesting the need for a new approach to asthma management. Poor adherence to prescribed maintenance therapy and over-reliance on SABA reliever medication is a common cause of inadequate control. This article reviews published data from 6- to 12-month, double-blind, RCT and open-label real-world studies involving budesonide/formoterol maintenance and reliever therapy (MART) and relevant comparator approaches to asthma management, and considers how these compare in achieving the treatment goals described in guidelines. The data confirm that patients with asthma treated with budesonide/formoterol MART achieved the same or better asthma symptom control compared with ICS/LABA plus SABA regimens at similar or higher ICS doses, with consistently lower rates of exacerbations and considerably lower annual requirement for oral corticosteroids. These findings have been confirmed across a range of severities of persistent asthma. With the MART approach, maintenance dosing ensures coverage for day-to-day control, and the use of a reliever with anti-inflammatory properties (budesonide/formoterol) provides extra doses of ICS as soon as symptoms prompt the use of reliever, resulting in a 40-50% reduction of exacerbations compared with an ICS-based treatment approach plus as-needed SABA as reliever. As-needed, budesonide/formoterol has also recently been shown to be more effective as a reliever in mild asthma than SABA alone, reducing exacerbations by up to 64% in the SYGMA studies.",2020,"The data confirm that patients with asthma treated with budesonide/formoterol MART achieved the same or better asthma symptom control compared with ICS/LABA plus SABA regimens at similar or higher ICS doses, with consistently lower rates of exacerbations and considerably lower annual requirement for oral corticosteroids.",['patients with asthma treated with'],"['budesonide/formoterol maintenance and reliever therapy (MART', 'budesonide/formoterol MART', 'budesonide/formoterol']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C1276807', 'cui_str': 'formoterol and budesonide'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]",[],,0.156575,"The data confirm that patients with asthma treated with budesonide/formoterol MART achieved the same or better asthma symptom control compared with ICS/LABA plus SABA regimens at similar or higher ICS doses, with consistently lower rates of exacerbations and considerably lower annual requirement for oral corticosteroids.","[{'ForeName': 'Christine R', 'Initials': 'CR', 'LastName': 'Jenkins', 'Affiliation': 'The George Institute for Global Health, Sydney, NSW, Australia.'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Bateman', 'Affiliation': 'Division of Pulmonology, Department of Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Malcolm R', 'Initials': 'MR', 'LastName': 'Sears', 'Affiliation': 'Michael G DeGroote School of Medicine, Faculty of Health Sciences, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': ""O'Byrne"", 'Affiliation': 'Michael G DeGroote School of Medicine, Faculty of Health Sciences, McMaster University, Hamilton, ON, Canada.'}]","Respirology (Carlton, Vic.)",['10.1111/resp.13804']
376,32271690,Health Related Quality of Life of Patients with Bladder Cancer in the RAZOR Trial: A Multi-Institutional Randomized Trial Comparing Robot versus Open Radical Cystectomy.,"PURPOSE


We evaluated health related quality of life following robotic and open radical cystectomy as a treatment for bladder cancer.
MATERIALS AND METHODS


Using the Randomized Open versus Robotic Cystectomy (RAZOR) trial population we assessed health related quality of life by using the Functional Assessment of Cancer Therapy (FACT)-Vanderbilt Cystectomy Index and the Short Form 8 Health Survey (SF-8) at baseline, 3 and 6 months postoperatively. The primary objective was to assess the impact of surgical approach on health related quality of life. As an exploratory analysis we assessed the impact of urinary diversion type on health related quality of life.
RESULTS


Analyses were performed in subsets of the per-protocol population of 302 patients. There was no statistically significant difference between the mean scores by surgical approach at any time point for any FACT-Vanderbilt Cystectomy Index subscale or composite score (p >0.05). The emotional well-being score increased over time in both surgical arms. Patients in the open arm showed significantly better SF-8 sores in the physical and mental summary scores at 6 months compared to baseline (p <0.05). Continent diversion (versus noncontinent) was associated with worse FACT-bladder-cystectomy score at 3 (p <0.01) but not at 6 months, and the SF-8 physical component was better in continent-diversion patients at 6 months (p=0.019).
CONCLUSIONS


Our data suggests lack of significant differences in the health related quality of life in robotic and open cystectomies. As robotic procedures become more widespread it is important to discuss this finding during counseling.",2020,There was no statistically significant difference between the mean scores by surgical approach at any time point for any FACT-VCI subscale or composite score (p>0.05).,['Patients with Bladder Cancer'],"['Robot versus Open Radical Cystectomy', 'Robotic Cystectomy (RAZOR', 'robotic and open radical cystectomy']","['worse FACT-BL-cys score', 'SF-8 physical component', 'Continent diversion', 'SF-8 sores', 'FACT-VCI subscale or composite score', 'Health-Related Quality of Life', 'health-related quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005684', 'cui_str': 'Malignant tumor of urinary bladder'}]","[{'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0194401', 'cui_str': 'Complete cystectomy'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0010651', 'cui_str': 'Bladder excision'}]","[{'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0010654', 'cui_str': 'Cysteine'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0429956', 'cui_str': 'Bowels: fully continent'}, {'cui': 'C0185033', 'cui_str': 'Diversion procedure'}, {'cui': 'C0234233', 'cui_str': 'Soreness'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",302.0,0.140481,There was no statistically significant difference between the mean scores by surgical approach at any time point for any FACT-VCI subscale or composite score (p>0.05).,"[{'ForeName': 'Maria F', 'Initials': 'MF', 'LastName': 'Becerra', 'Affiliation': 'Department of Urology, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Venkatramani', 'Affiliation': 'Department of Urology, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Isildinha M', 'Initials': 'IM', 'LastName': 'Reis', 'Affiliation': 'Division of Biostatistics, Department of Public Health Sciences, Miller School of Medicine, University of Miami, Miami, Florida.'}, {'ForeName': 'Nachiketh', 'Initials': 'N', 'LastName': 'Soodana-Prakash', 'Affiliation': 'Department of Urology, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Sanoj', 'Initials': 'S', 'LastName': 'Punnen', 'Affiliation': 'Department of Urology, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Mark L', 'Initials': 'ML', 'LastName': 'Gonzalgo', 'Affiliation': 'Department of Urology, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Shyamal', 'Initials': 'S', 'LastName': 'Raolji', 'Affiliation': 'Department of Urology, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Erik P', 'Initials': 'EP', 'LastName': 'Castle', 'Affiliation': 'Department of Urology, Mayo Clinic, Phoenix, Arizona.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Woods', 'Affiliation': 'Department of Urology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Svatek', 'Affiliation': 'Department of Urology, Division of Urologic Oncology, University of Texas Health Science Center at San Antonio, San Antonio, Texas.'}, {'ForeName': 'Alon Z', 'Initials': 'AZ', 'LastName': 'Weizer', 'Affiliation': 'Department of Urology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Badrinath R', 'Initials': 'BR', 'LastName': 'Konety', 'Affiliation': 'Department of Urology, University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Mathew', 'Initials': 'M', 'LastName': 'Tollefson', 'Affiliation': 'Department of Urology, Mayo Clinic, Phoenix, Arizona.'}, {'ForeName': 'Tracey L', 'Initials': 'TL', 'LastName': 'Krupski', 'Affiliation': 'Department of Urology, University of Virginia Health Science Center, Charlottesville, Virginia.'}, {'ForeName': 'Norm D', 'Initials': 'ND', 'LastName': 'Smith', 'Affiliation': 'Department of Urology, University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Shabsigh', 'Affiliation': 'Department of Urology, Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Barocas', 'Affiliation': 'Department of Urology, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Marcus L', 'Initials': 'ML', 'LastName': 'Quek', 'Affiliation': 'Department of Urology, Loyola University Medical Center, Maywood, Illinois.'}, {'ForeName': 'Atreya', 'Initials': 'A', 'LastName': 'Dash', 'Affiliation': 'Department of Urology, University of Washington, Seattle, Washington.'}, {'ForeName': 'Dipen J', 'Initials': 'DJ', 'LastName': 'Parekh', 'Affiliation': 'Department of Urology, University of Miami Miller School of Medicine, Miami, Florida.'}]",The Journal of urology,['10.1097/JU.0000000000001029']
377,32271919,Bioavailable Methionine Assessed Using the Indicator Amino Acid Oxidation Method Is Greater When Cooked Chickpeas and Steamed Rice Are Combined in Healthy Young Men.,"BACKGROUND


In general, pulse protein is limiting in the indispensable amino acid methionine, and antinutritional factors in pulses can affect methionine bioavailability. Complementation with grains such as rice can improve pulse protein quality, but knowledge of methionine bioavailability in pulses and grains is necessary to correct for available methionine when planning and assessing dietary protein intake.
OBJECTIVES


The study objectives were to determine the bioavailability of methionine in rice and chickpeas separately and to assess the effect of complementation of chickpeas and rice.
METHODS


Eleven healthy young men (<30 y, BMI <25 kg/m2) were studied in a repeated-measures design using the indicator amino acid oxidation (IAAO) method, with l-[1-13C]phenylalanine as the indicator. Each received 7 or 10 methionine intakes in random order: 4 intakes of l-methionine-0.5, 1, 2, and 3 mg⋅kg-1⋅d-1 (reference diet); 3 intakes of methionine from rice and from chickpeas; and 3 intakes from the mixed meal of chickpeas plus rice (test diets). The bioavailability of methionine and the effect of complementation were assessed by comparing the IAAO response to varying intakes of methionine in rice, in cooked Canadian chickpeas, and in rice plus chickpeas combined compared with the IAAO response to l-methionine intakes in the reference protein (crystalline amino acid mixture patterned after egg protein) using the slope ratio method.
RESULTS


The bioavailability of methionine from rice and from chickpeas was 100% and 63%, respectively. Complementation of cooked chickpeas with rice decreased the oxidation of l-[1-13C]phenylalanine by up to 14% (P < 0.05), suggesting an improved protein quality of the combined chickpeas plus rice protein.
CONCLUSIONS


When chickpeas are the main protein source in the diet of young adult men, the combination of rice and chickpeas in a 3:1 ratio is recommended to improve dietary protein quality. This trial was registered at clinicaltrials.gov as NCT03339154 and NCT03674736.",2020,"Complementation of cooked chickpeas with rice decreased the oxidation of l-[1-13C]phenylalanine by up to 14% (P < 0.05), suggesting an improved protein quality of the combined chickpeas plus rice protein.
","['young adult men', 'Eleven healthy young men (<30 y, BMI <25 kg/m2', 'Healthy Young Men']","['Cooked Chickpeas and Steamed Rice', '10 methionine intakes in random order: 4 intakes of l-methionine-0.5, 1, 2, and 3 mg⋅kg-1⋅d-1 (reference diet); 3 intakes of methionine from rice and from chickpeas; and 3 intakes from the mixed meal of chickpeas plus rice (test diets', 'indicator amino acid oxidation (IAAO) method, with l-[1-13C]phenylalanine', 'Bioavailable Methionine']","['oxidation of l-[1-13C]phenylalanine', 'bioavailability of methionine', 'protein quality', 'pulse protein quality']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}]","[{'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C0950052', 'cui_str': 'Chick peas'}, {'cui': 'C0038225', 'cui_str': 'Steam'}, {'cui': 'C0035567', 'cui_str': 'Rice'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0452401', 'cui_str': 'Test diet'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0002520', 'cui_str': 'amino acids'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0935763', 'cui_str': 'Bioavailable'}]","[{'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}]",11.0,0.0349997,"Complementation of cooked chickpeas with rice decreased the oxidation of l-[1-13C]phenylalanine by up to 14% (P < 0.05), suggesting an improved protein quality of the combined chickpeas plus rice protein.
","[{'ForeName': 'Mahroukh', 'Initials': 'M', 'LastName': 'Rafii', 'Affiliation': 'Research Institute, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Paul B', 'Initials': 'PB', 'LastName': 'Pencharz', 'Affiliation': 'Research Institute, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Ronald O', 'Initials': 'RO', 'LastName': 'Ball', 'Affiliation': 'Department of Nutritional Sciences, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Tomlinson', 'Affiliation': 'Research Institute, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Rajavel', 'Initials': 'R', 'LastName': 'Elango', 'Affiliation': 'Department of Pediatrics, School of Population and Public Health, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Glenda', 'Initials': 'G', 'LastName': 'Courtney-Martin', 'Affiliation': 'Research Institute, Hospital for Sick Children, Toronto, Ontario, Canada.'}]",The Journal of nutrition,['10.1093/jn/nxaa086']
378,32096852,Comparison of Abbreviated Breast MRI vs Digital Breast Tomosynthesis for Breast Cancer Detection Among Women With Dense Breasts Undergoing Screening.,"Importance


Improved screening methods for women with dense breasts are needed because of their increased risk of breast cancer and of failed early diagnosis by screening mammography.
Objective


To compare the screening performance of abbreviated breast magnetic resonance imaging (MRI) and digital breast tomosynthesis (DBT) in women with dense breasts.
Design, Setting, and Participants


Cross-sectional study with longitudinal follow-up at 48 academic, community hospital, and private practice sites in the United States and Germany, conducted between December 2016 and November 2017 among average-risk women aged 40 to 75 years with heterogeneously dense or extremely dense breasts undergoing routine screening. Follow-up ascertainment of cancer diagnoses was complete through September 12, 2019.
Exposures


All women underwent screening by both DBT and abbreviated breast MRI, performed in randomized order and read independently to avoid interpretation bias.
Main Outcomes and Measures


The primary end point was the invasive cancer detection rate. Secondary outcomes included sensitivity, specificity, additional imaging recommendation rate, and positive predictive value (PPV) of biopsy, using invasive cancer and ductal carcinoma in situ (DCIS) to define a positive reference standard. All outcomes are reported at the participant level. Pathology of core or surgical biopsy was the reference standard for cancer detection rate and PPV; interval cancers reported until the next annual screen were included in the reference standard for sensitivity and specificity.
Results


Among 1516 enrolled women, 1444 (median age, 54 [range, 40-75] years) completed both examinations and were included in the analysis. The reference standard was positive for invasive cancer with or without DCIS in 17 women and for DCIS alone in another 6. No interval cancers were observed during follow-up. Abbreviated breast MRI detected all 17 women with invasive cancer and 5 of 6 women with DCIS. Digital breast tomosynthesis detected 7 of 17 women with invasive cancer and 2 of 6 women with DCIS. The invasive cancer detection rate was 11.8 (95% CI, 7.4-18.8) per 1000 women for abbreviated breast MRI vs 4.8 (95% CI, 2.4-10.0) per 1000 women for DBT, a difference of 7 (95% CI, 2.2-11.6) per 1000 women (exact McNemar P = .002). For detection of invasive cancer and DCIS, sensitivity was 95.7% (95% CI, 79.0%-99.2%) with abbreviated breast MRI vs 39.1% (95% CI, 22.2%-59.2%) with DBT (P = .001) and specificity was 86.7% (95% CI, 84.8%-88.4%) vs 97.4% (95% CI, 96.5%-98.1%), respectively (P < .001). The additional imaging recommendation rate was 7.5% (95% CI, 6.2%-9.0%) with abbreviated breast MRI vs 10.1% (95% CI, 8.7%-11.8%) with DBT (P = .02) and the PPV was 19.6% (95% CI, 13.2%-28.2%) vs 31.0% (95% CI, 17.0%-49.7%), respectively (P = .15).
Conclusions and Relevance


Among women with dense breasts undergoing screening, abbreviated breast MRI, compared with DBT, was associated with a significantly higher rate of invasive breast cancer detection. Further research is needed to better understand the relationship between screening methods and clinical outcome.
Trial Registration


ClinicalTrials.gov Identifier: NCT02933489.",2020,"For detection of invasive cancer and DCIS, sensitivity was 95.7% (95% CI, 79.0%-99.2%) with abbreviated breast MRI vs 39.1% (95% CI, 22.2%-59.2%) with DBT (P = .001) and specificity was 86.7% (95% CI, 84.8%-88.4%) vs 97.4% (95% CI, 96.5%-98.1%), respectively (P < .001).","['Women With Dense Breasts Undergoing Screening', 'women with dense breasts', '17 women with invasive cancer and 2 of 6 women with DCIS', '1516 enrolled women, 1444 (median age, 54 [range, 40-75] years) completed both examinations and were included in the analysis', 'Breast Cancer Detection', 'Participants\n\n\nCross-sectional study with longitudinal follow-up at 48 academic, community hospital, and private practice sites in the United States and Germany, conducted between December 2016 and November 2017 among average-risk women aged 40 to 75 years with heterogeneously dense or extremely dense breasts undergoing routine screening', '17 women with invasive cancer and 5 of 6 women with DCIS']","['abbreviated breast magnetic resonance imaging (MRI) and digital breast tomosynthesis (DBT', 'Abbreviated Breast MRI vs Digital Breast Tomosynthesis']","['additional imaging recommendation rate', 'PPV', 'No interval cancers', 'sensitivity, specificity, additional imaging recommendation rate, and positive predictive value (PPV) of biopsy, using invasive cancer and ductal carcinoma in situ (DCIS', 'invasive cancer detection rate', 'rate of invasive breast cancer detection', 'specificity']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439794', 'cui_str': 'Dense (qualifier value)'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0010362', 'cui_str': 'Disease Frequency Surveys'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0020003', 'cui_str': 'Hospitals, Community'}, {'cui': 'C0033174', 'cui_str': 'Private Practice'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205403', 'cui_str': 'Extreme (qualifier value)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}]","[{'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C3472347', 'cui_str': 'Breast Tomosyntheses, X-ray'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}]","[{'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C2919572', 'cui_str': 'Malignant neoplasm detection during interval between recommended screening examinations (finding)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0007124', 'cui_str': 'Ductal Carcinoma In Situ'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}]",1516.0,0.363375,"For detection of invasive cancer and DCIS, sensitivity was 95.7% (95% CI, 79.0%-99.2%) with abbreviated breast MRI vs 39.1% (95% CI, 22.2%-59.2%) with DBT (P = .001) and specificity was 86.7% (95% CI, 84.8%-88.4%) vs 97.4% (95% CI, 96.5%-98.1%), respectively (P < .001).","[{'ForeName': 'Christopher E', 'Initials': 'CE', 'LastName': 'Comstock', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Constantine', 'Initials': 'C', 'LastName': 'Gatsonis', 'Affiliation': 'Department of Biostatistics and Center for Statistical Sciences, Brown University School of Public Health, Providence, Rhode Island.'}, {'ForeName': 'Gillian M', 'Initials': 'GM', 'LastName': 'Newstead', 'Affiliation': 'University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Bradley S', 'Initials': 'BS', 'LastName': 'Snyder', 'Affiliation': 'Center for Statistical Sciences, Brown University School of Public Health, Providence, Rhode Island.'}, {'ForeName': 'Ilana F', 'Initials': 'IF', 'LastName': 'Gareen', 'Affiliation': 'Center for Statistical Sciences, Department of Epidemiology, Brown University School of Public Health, Providence, Rhode Island.'}, {'ForeName': 'Jennifer T', 'Initials': 'JT', 'LastName': 'Bergin', 'Affiliation': 'UW Cancer Center at ProHealth Care, Waukesha, Wisconsin.'}, {'ForeName': 'Habib', 'Initials': 'H', 'LastName': 'Rahbar', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Janice S', 'Initials': 'JS', 'LastName': 'Sung', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Jacobs', 'Affiliation': 'West Michigan Cancer Center, Kalamazoo.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Harvey', 'Affiliation': 'University of Virginia Cancer Center, Charlottesville.'}, {'ForeName': 'Mary H', 'Initials': 'MH', 'LastName': 'Nicholson', 'Affiliation': 'Community Hospital, Munster, Indiana.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Ward', 'Affiliation': 'Rhode Island Hospital, Providence.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Holt', 'Affiliation': 'Delaware/Christiana Care NCORP, Newark.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Prather', 'Affiliation': 'Gundersen Health System, La Crosse, Wisconsin.'}, {'ForeName': 'Kathy D', 'Initials': 'KD', 'LastName': 'Miller', 'Affiliation': 'Indiana University, Indianapolis.'}, {'ForeName': 'Mitchell D', 'Initials': 'MD', 'LastName': 'Schnall', 'Affiliation': 'University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Christiane K', 'Initials': 'CK', 'LastName': 'Kuhl', 'Affiliation': 'University Hospital of RWTH Aachen, Aachen, Germany.'}]",JAMA,['10.1001/jama.2020.0572']
379,31594878,Reducing unnecessary vitamin testing in general practice: barriers and facilitators according to general practitioners and patients.,"OBJECTIVE


There has been an increase in testing of vitamins in patients in general practice, often based on irrational indications or for non-specific symptoms, causing increasing healthcare expenditures and medicalisation of patients. So far, there is little evidence of effective strategies to reduce this overtesting in general practice. Therefore, the aim of this qualitative study was to explore the barriers and facilitators for reducing the number of (unnecessary) vitamin D and B 12  laboratory tests ordered.
DESIGN AND SETTING


This qualitative study, based on a grounded theory design, used semistructured interviews among general practitioners (GPs) and patients from two primary care networks (147 GPs, 195 000 patients). These networks participated in the Reducing Vitamin Testing in Primary Care Practice (REVERT) study, a clustered randomized trial comparing two de-implementation strategies to reduce test ordering in primary care in the Netherlands.
PARTICIPANTS


Twenty-one GPs, with a maximum of 1 GP per practice who took part in the REVERT study, and 22 patients (who were invited by their GP during vitamin-related consultations) were recruited, from which 20 GPs and 19 patients agreed to participate in this study.
RESULTS


The most important factor hampering vitamin-test reduction programmes is the mismatch between patients and medical professionals regarding the presumed appropriate indications for testing for vitamin D and B 12 . In contrast, the most important facilitator for vitamin-test reduction may be updating GPs' knowledge about test indications and their awareness of their own testing behaviour.
CONCLUSION


To achieve a sustainable reduction in vitamin testing, guidelines with clear and uniform recommendations on evidence-based indications for vitamin testing, combined with regular (individual) feedback on test-ordering behaviour, are needed. Moreover, the general public needs access to clear and reliable information on vitamin testing. Further research is required to measure the effect of these strategies on the number of vitamin test requests.
TRIAL REGISTRATION NUMBER


WAG/mb/16/039555.",2019,"PARTICIPANTS


Twenty-one GPs, with a maximum of 1 GP per practice who took part in the REVERT study, and 22 patients (who were invited by their GP during vitamin-related consultations) were recruited, from which 20 GPs and 19 patients agreed to participate in this study.
","['general practitioners (GPs) and patients from two primary care networks (147 GPs, 195\u2009000 patients', 'Twenty-one GPs, with a maximum of 1 GP per practice who took part in the REVERT study, and 22 patients (who were invited by their GP during vitamin-related consultations) were recruited, from which 20 GPs and 19 patients agreed to participate in this study', 'general practitioners and patients']",[],['number of (unnecessary) vitamin D'],"[{'cui': 'C0017319', 'cui_str': 'Physicians, General Practice'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C3715213', 'cui_str': '21 (qualifier value)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0347984', 'cui_str': 'During (attribute)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}]",[],"[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}]",,0.0971063,"PARTICIPANTS


Twenty-one GPs, with a maximum of 1 GP per practice who took part in the REVERT study, and 22 patients (who were invited by their GP during vitamin-related consultations) were recruited, from which 20 GPs and 19 patients agreed to participate in this study.
","[{'ForeName': 'H', 'Initials': 'H', 'LastName': 'Hofstede', 'Affiliation': 'Department of General Practice, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'H A M', 'Initials': 'HAM', 'LastName': 'van der Burg', 'Affiliation': 'Department of General Practice, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'B C', 'Initials': 'BC', 'LastName': 'Mulder', 'Affiliation': 'Strategic Communication Group, Wageningen University, Wageningen, The Netherlands.'}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Bohnen', 'Affiliation': 'Department of General Practice, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'P J E', 'Initials': 'PJE', 'LastName': 'Bindels', 'Affiliation': 'Department of General Practice, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'N J', 'Initials': 'NJ', 'LastName': 'de Wit', 'Affiliation': 'Department of General Practice, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'E I T', 'Initials': 'EIT', 'LastName': 'de Schepper', 'Affiliation': 'Department of General Practice, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'S F', 'Initials': 'SF', 'LastName': 'van Vugt', 'Affiliation': 'Department of General Practice, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands s.f.vanvugt@umcutrecht.nl.'}]",BMJ open,['10.1136/bmjopen-2019-029760']
380,31594889,"Web-based support for self-management strategies versus usual care for people with COPD in primary healthcare: a protocol for a randomised, 12-month, parallel-group pragmatic trial.","INTRODUCTION


The use of adequate self-management strategies for people with chronic obstructive pulmonary disease (COPD) may increase the level of physical activity (PA), improve health-related quality of life (HRQoL) and reduce healthcare use. Whether web-based support in addition to prompts (email and SMS) could be used to promote self-management strategies to facilitate behaviour change in people with COPD is not clear. This clinical trial aims to generate evidence on the effect of a web-based solution, the COPD Web, in a cohort of people with COPD in a primary healthcare context.
METHODS AND ANALYSIS


The overall design is a pragmatic randomised controlled trial with preassessments and postassessments (3 and 12 months) and an implementation and user experience evaluation. People with a diagnosis of COPD, treated in primary healthcare will be eligible for the study. A total of 144 participants will be enrolled by healthcare professionals at included primary healthcare units and, after fulfilled baseline assessments, randomised to either control or intervention group. All participants will receive usual care, a pedometer and a leaflet about the importance of PA. Participants in the intervention will, in addition, get access to the COPD Web, an interactive self-managed website that aims to support people with COPD in self-management strategies. They will also continuously get support from prompts with a focus on behaviour change.The effect on participants' PA, dyspnoea, COPD-related symptoms, HRQoL and health economics will be assessed using accelerometer and questionnaires. To identify enablers and barriers for the use of web-based support to change behaviour, semistructured interviews will be conducted in a subgroup of participants at the 3 months follow-up.
ETHICS AND DISSEMINATION


Ethical approval has been received from the Regional Ethical Review Board in Umeå, Sweden. Dnr 2018-274-31. Findings will be presented at conferences, submitted for publication in peer-reviewed journals and presented to the involved healthcare professionals, participants and patient organisations.
TRIAL REGISTRATION NUMBER


NCT03746873.",2019,Whether web-based support in addition to prompts (email and SMS) could be used to promote self-management strategies to facilitate behaviour change in people with COPD is not clear.,"['people with chronic obstructive pulmonary disease (COPD', 'People with a diagnosis of COPD, treated in primary healthcare', 'people with COPD in primary healthcare', '144 participants will be enrolled by healthcare professionals at included primary healthcare units and, after fulfilled baseline assessments, randomised to either control or intervention group', 'people with COPD in a primary healthcare context']",[],"[""participants' PA, dyspnoea, COPD-related symptoms, HRQoL and health economics"", 'level of physical activity (PA), improve health-related quality of life (HRQoL']","[{'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C1704312', 'cui_str': 'Healthcare professional (occupation)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0449255', 'cui_str': 'Context (attribute)'}]",[],"[{'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013557', 'cui_str': 'economics'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0034380'}]",144.0,0.227724,Whether web-based support in addition to prompts (email and SMS) could be used to promote self-management strategies to facilitate behaviour change in people with COPD is not clear.,"[{'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Stenlund', 'Affiliation': 'Department of Community Medicine and Rehabilitation, Physiotherapy, Umeå University, Umeå, Sweden tobias.stenlund@umu.se.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Nyberg', 'Affiliation': 'Department of Community Medicine and Rehabilitation, Physiotherapy, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Lundell', 'Affiliation': 'Department of Community Medicine and Rehabilitation, Physiotherapy, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Wadell', 'Affiliation': 'Department of Community Medicine and Rehabilitation, Physiotherapy, Umeå University, Umeå, Sweden.'}]",BMJ open,['10.1136/bmjopen-2019-030788']
381,31594891,"Platelet-Rich plasma Injection Management for Ankle osteoarthritis study (PRIMA): protocol of a Dutch multicentre, stratified, block-randomised, double-blind, placebo-controlled trial.","INTRODUCTION


Platelet-rich plasma (PRP) is a potentially efficacious treatment for ankle osteoarthritis (OA), but its use has not been examined in high-quality studies. Systematic reviews show that PRP injections significantly decrease pain and improve function in patients with knee OA. Ankle OA is more common than hip or knee OA in the young active population; with a prevalence of 3.4%.PRP injections in ankle OA are shown to be safe and improve quality of life over time, but no randomised controlled trial has been conducted. Our randomised controlled trial will evaluate the efficacy of PRP injections for symptom reduction and functional improvement, compared with placebo, in the treatment of ankle (talocrural) OA.
METHODS AND ANALYSIS


We will conduct the Platelet-Rich plasma Injection Management for Ankle OA study: a multicentre, randomised, placebo-controlled trial. One hundred patients suffering from ankle OA will be randomised into two treatment groups: PRP injection or placebo (saline) injection. Both groups will receive two injections of PRP or placebo at an interval of 6 weeks. Primary outcome is the American Orthopaedic Foot and Ankle Society score at 26 weeks. Secondary outcomes determined at several follow-up moments up to 5 years, include Ankle Osteoarthritis Score, Foot and Ankle Outcome Score, pain subscale of (0-40), Visual Analogue Scale score (0-100), Ankle Activity Score (0-10), subjective patient satisfaction Short Form Health Survey-36, Global Attainment Scaling and the EuroQol-5 dimensions-3 levels utility score. A cost-effectiveness analysis will be performed at 1 year.
ETHICS AND DISSEMINATION


The study is approved by the Medical Ethics Review Committee Amsterdam Medical Center, the Netherlands (ABR 2018-042, approved 23 July 2018) and registered in the Netherlands trial register (NTR7261). Results and new knowledge will be disseminated through the Dutch Arthritis Association (ReumaNederland), Dutch patient federation, conferences and published in a scientific peer-reviewed journal.
TRIAL REGISTRATION NUMBER


NTR7261.",2019,One hundred patients suffering from ankle OA will be randomised into two treatment groups: PRP injection or placebo (saline) injection.,"['patients with knee OA', 'One hundred patients suffering from ankle OA']","['Platelet-Rich plasma Injection Management', 'placebo', 'PRP injections', 'Platelet-rich plasma (PRP', 'PRP or placebo', 'PRP injection or placebo (saline) injection']","['several follow-up moments up to 5 years, include Ankle Osteoarthritis Score, Foot and Ankle Outcome Score, pain subscale of (0-40), Visual Analogue Scale score (0-100), Ankle Activity Score (0-10), subjective patient satisfaction Short Form Health Survey-36, Global Attainment Scaling and the EuroQol-5 dimensions-3 levels utility score', 'pain and improve function', 'American Orthopaedic Foot and Ankle Society score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}]","[{'cui': 'C0370220', 'cui_str': 'Platelet rich plasma (substance)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0242848', 'cui_str': 'PrP (GSS)'}]","[{'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0409931', 'cui_str': 'Osteoarthritis of ankle (disorder)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0037455', 'cui_str': 'Societies'}]",100.0,0.561917,One hundred patients suffering from ankle OA will be randomised into two treatment groups: PRP injection or placebo (saline) injection.,"[{'ForeName': 'Lda', 'Initials': 'L', 'LastName': 'Paget', 'Affiliation': 'Orthopaedic Surgery, Amsterdam UMC-Location AMC, Amsterdam, The Netherlands l.d.paget@amsterdamumc.nl.'}, {'ForeName': 'Sma', 'Initials': 'S', 'LastName': 'Bierma-Zeinstra', 'Affiliation': 'Department of General Practice, Erasmus University Medical Centre, Rotterdam, The Netherlands.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Goedegebuure', 'Affiliation': 'Sports Medicine, OLVG, The Sport Physician Group, Amsterdam, The Netherlands.'}, {'ForeName': 'Gmmj', 'Initials': 'G', 'LastName': 'Kerkhoffs', 'Affiliation': 'Orthopaedic Surgery, Amsterdam UMC-Location AMC, Amsterdam, The Netherlands.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Krips', 'Affiliation': 'Orthopaedic Surgery, Flevoziekenhuis, Almere, The Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Maas', 'Affiliation': 'Academic Center for Evidence-based Sports medicine (ACES), Amsterdam UMC, Amsterdam, The Netherlands.'}, {'ForeName': 'M H', 'Initials': 'MH', 'LastName': 'Moen', 'Affiliation': 'Sports Medicine, Bergman Clinics, Naarden, The Netherlands.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Reurink', 'Affiliation': 'Sports Medicine, OLVG, The Sport Physician Group, Amsterdam, The Netherlands.'}, {'ForeName': 'Sas', 'Initials': 'S', 'LastName': 'Stufkens', 'Affiliation': 'Orthopaedic Surgery, Amsterdam UMC-Location AMC, Amsterdam, The Netherlands.'}, {'ForeName': 'R J', 'Initials': 'RJ', 'LastName': 'de Vos', 'Affiliation': 'Orthopaedics and Sports Medicine, Erasmus University Medical Centre, Rotterdam, The Netherlands.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Weir', 'Affiliation': 'Orthopaedics and Sports Medicine, Erasmus University Medical Centre, Rotterdam, The Netherlands.'}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Tol', 'Affiliation': 'Academic Center for Evidence-based Sports medicine (ACES), Amsterdam UMC, Amsterdam, The Netherlands.'}]",BMJ open,['10.1136/bmjopen-2019-030961']
382,31594892,"Health outcomes, utility and costs of returning incidental results from genomic sequencing in a Canadian cancer population: protocol for a mixed-methods randomised controlled trial.","INTRODUCTION


Genomic sequencing has rapidly transitioned into clinical practice, improving diagnosis and treatment options for patients with hereditary disorders. However, large-scale implementation of genomic sequencing faces challenges, especially with regard to the return of incidental results, which refer to genetic variants uncovered during testing that are unrelated to the primary disease under investigation, but of potential clinical significance. High-quality evidence evaluating health outcomes and costs of receiving incidental results is critical for the adoption of genomic sequencing into clinical care and to understand the unintended consequences of adoption of genomic sequencing. We aim to evaluate the health outcomes and costs of receiving incidental results for patients undergoing genomic sequencing.
METHODS AND ANALYSIS


We will compare health outcomes and costs of receiving, versus not receiving, incidental results for adult patients with cancer undergoing genomic sequencing in a mixed-methods randomised controlled trial. Two hundred and sixty patients who have previously undergone first or second-tier genetic testing for cancer and received uninformative results will be recruited from familial cancer clinics in Toronto, Ontario. Participants in both arms will receive cancer-related results. Participants in the intervention arm have the option to receive incidental results. Our primary outcome is psychological distress at 2 weeks following return of results. Secondary outcomes include behavioural consequences, clinical and personal utility assessed over the 12 months after results are returned and health service use and costs at 12 months and 5 years. A subset of participants and providers will complete qualitative interviews about utility of incidental results.
ETHICS AND DISSEMINATION


This study has been approved by Clinical Trials Ontario Streamlined Research Ethics Review System that provides ethical review and oversight for multiple sites participating in the same clinical trial in Ontario.Results from the trial will be shared through stakeholder workshops, national and international conferences, and peer-reviewed journals.
TRIAL REGISTRATION NUMBER


NCT03597165.",2019,"Secondary outcomes include behavioural consequences, clinical and personal utility assessed over the 12 months after results are returned and health service use and costs at 12 months and 5 years.","['patients with hereditary disorders', 'multiple sites participating in the same clinical trial in Ontario', 'Two hundred and sixty patients who have previously undergone first or second-tier genetic testing for cancer and received uninformative results will be recruited from familial cancer clinics in Toronto, Ontario', 'patients undergoing genomic sequencing', 'adult patients with cancer undergoing genomic sequencing in a mixed-methods randomised controlled trial']",[],"['behavioural consequences, clinical and personal utility assessed over the 12 months after results are returned and health service use and costs', 'psychological distress', 'Health outcomes, utility and costs of returning incidental results']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019247', 'cui_str': 'Hereditary Diseases'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C4517669', 'cui_str': 'Two hundred and sixty'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0679560', 'cui_str': 'Genetic Testing'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1611743', 'cui_str': 'Familial (FPAH)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0887950', 'cui_str': 'Genomics'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",[],"[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0018747', 'cui_str': 'Health Services'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0444507', 'cui_str': 'Incidental (qualifier value)'}]",260.0,0.234148,"Secondary outcomes include behavioural consequences, clinical and personal utility assessed over the 12 months after results are returned and health service use and costs at 12 months and 5 years.","[{'ForeName': 'Salma', 'Initials': 'S', 'LastName': 'Shickh', 'Affiliation': 'Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Clausen', 'Affiliation': ""Genomics Health Services Research Program, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Chloe', 'Initials': 'C', 'LastName': 'Mighton', 'Affiliation': 'Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Gutierrez Salazar', 'Affiliation': ""Genomics Health Services Research Program, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Kathleen-Rose', 'Initials': 'KR', 'LastName': 'Zakoor', 'Affiliation': 'Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, Sinai Health System, Toronto, Ontario, Canada.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Kodida', 'Affiliation': ""Genomics Health Services Research Program, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Reble', 'Affiliation': ""Genomics Health Services Research Program, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Elser', 'Affiliation': 'Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Eisen', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Seema', 'Initials': 'S', 'LastName': 'Panchal', 'Affiliation': 'Marvelle Koffler Breast Centre, Mount Sinai Hospital, Sinai Health System, Toronto, Ontario, Canada.'}, {'ForeName': 'Melyssa', 'Initials': 'M', 'LastName': 'Aronson', 'Affiliation': 'Zane Cohen Centre for Digestive Diseases, Mount Sinai Hospital, Sinai Health System, Toronto, Ontario, Canada.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Graham', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Susan Randall', 'Initials': 'SR', 'LastName': 'Armel', 'Affiliation': 'Familial Breast Ovarian Cancer Clinic, Princess Margaret Cancer Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Chantal F', 'Initials': 'CF', 'LastName': 'Morel', 'Affiliation': 'Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Ramzi', 'Initials': 'R', 'LastName': 'Fattouh', 'Affiliation': ""Department of Laboratory Medicine, St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Glogowski', 'Affiliation': 'GeneDx, Elmwood Park, New Jersey, USA.'}, {'ForeName': 'Kasmintan A', 'Initials': 'KA', 'LastName': 'Schrader', 'Affiliation': 'Department of Molecular Oncology and Hereditary Cancer Program, BC Cancer Agency, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Jada G', 'Initials': 'JG', 'LastName': 'Hamilton', 'Affiliation': 'Clinical Genetics Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York City, New York, USA.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Offit', 'Affiliation': 'Clinical Genetics Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York City, New York, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Robson', 'Affiliation': 'Clinical Genetics Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York City, New York, USA.'}, {'ForeName': 'June C', 'Initials': 'JC', 'LastName': 'Carroll', 'Affiliation': 'Ray D Wolfe Department of Family Medicine, Mount Sinai Hospital, Sinai Health System, Toronto, Ontario, Canada.'}, {'ForeName': 'Wanrudee', 'Initials': 'W', 'LastName': 'Isaranuwatchai', 'Affiliation': 'Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Raymond H', 'Initials': 'RH', 'LastName': 'Kim', 'Affiliation': 'Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Lerner-Ellis', 'Affiliation': 'Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, Sinai Health System, Toronto, Ontario, Canada.'}, {'ForeName': 'Kevin E', 'Initials': 'KE', 'LastName': 'Thorpe', 'Affiliation': ""Applied Health Research Centre, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Laupacis', 'Affiliation': 'Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Bombard', 'Affiliation': 'Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada yvonne.bombard@utoronto.ca.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-031092']
383,30927126,Laparoscopic Simulation in Reverse and Side Alignment Impact on Forward Alignment Performance: A Randomized Controlled Trial.,"BACKGROUND


The influence of visual-spatial discordance during training on laparoscopic skills is poorly understood. It has been proposed that training in visual-spatial discordant situations can improve performance in the forward alignment, which was the basis of our hypothesis. Our study's aim was to conduct a randomized control trial to explore the impact of simulated training in visual-spatial discordant situations on forward alignment performance.
METHODS


The participants were 80 medical students who were randomized into four groups. Group A served as the control and performed all peg transfers in the forward alignment. Groups B, C, and D experienced varied rounds of either increasing or decreasing sensorimotor discordance. The students were trained and tested using the peg transfer task used in the Fundamentals of Laparoscopic Surgery curriculum. Based on the group, each student performed 10 peg transfer practice rounds in their assigned alignment. After each practice session, each student was tested and scored in forward alignment performance. A baseline test, followed by three practice sessions, and three tests were done.
RESULTS


Group A (control) demonstrated a statistically significant overall increase in scoring of 37.1% from baseline when compared to the final test. Groups B, C, and D showed improvements of 3.7%, 27.1%, and 19.3%, respectively, between baseline and the final test, yet none demonstrated consistent linear improvements. On multi-variate analysis, students who practiced in the side or reverse alignment positions scored 25 and 37 points lower, respectively, than students who practiced in the forward alignment.
CONCLUSION


Our study suggests that training in visual-spatial discordant conditions does not lead to the development of forward alignment laparoscopic skills. This could have important implications when developing future laparoscopic skills training curriculums. To our knowledge, this is the largest study to date assessing the impacts of training in visual-spatial discordance situations on performance in the forward alignment.",2020,Our study suggests that training in visual-spatial discordant conditions does not lead to the development of forward alignment laparoscopic skills.,"['Forward Alignment Performance', 'students who practiced in the side or reverse alignment positions scored 25 and 37 points lower, respectively, than students who practiced in the forward alignment', 'participants were 80 medical students']","['peg transfer task used in the Fundamentals of Laparoscopic Surgery curriculum', 'simulated training']",['sensorimotor discordance'],"[{'cui': 'C0439780', 'cui_str': 'Forward (qualifier value)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C1561964', 'cui_str': 'Patient Positioning'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0051533', 'cui_str': 'Am 80'}, {'cui': 'C0038495', 'cui_str': 'Students, Medical'}]","[{'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0751429', 'cui_str': 'Surgical Procedures, Laparoscopic'}, {'cui': 'C0220815', 'cui_str': 'curriculum'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]",[],80.0,0.0865324,Our study suggests that training in visual-spatial discordant conditions does not lead to the development of forward alignment laparoscopic skills.,"[{'ForeName': 'Nashwa', 'Initials': 'N', 'LastName': 'Khogali-Jakary', 'Affiliation': ', Troy, USA.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Kanitra', 'Affiliation': 'Department of Surgery, Ascension St. John Hospital and Medical Center, Detroit, MI, 48236, USA.'}, {'ForeName': 'Pamela S', 'Initials': 'PS', 'LastName': 'Haan', 'Affiliation': 'Department of Surgery, Michigan State University College of Human Medicine, 1200 E. Michigan Ave, Suite 655, Lansing, MI, 48912, USA.'}, {'ForeName': 'Cheryl I', 'Initials': 'CI', 'LastName': 'Anderson', 'Affiliation': 'Department of Surgery, Michigan State University College of Human Medicine, 1200 E. Michigan Ave, Suite 655, Lansing, MI, 48912, USA.'}, {'ForeName': 'Alan T', 'Initials': 'AT', 'LastName': 'Davis', 'Affiliation': 'Department of Surgery, Michigan State University College of Human Medicine, 1200 E. Michigan Ave, Suite 655, Lansing, MI, 48912, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Henry', 'Affiliation': ', Kailua, USA.'}, {'ForeName': 'Rama', 'Initials': 'R', 'LastName': 'Gupta', 'Affiliation': 'Department of Surgery, Michigan State University College of Human Medicine, 1200 E. Michigan Ave, Suite 655, Lansing, MI, 48912, USA.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Moon', 'Affiliation': 'Department of Surgery, Michigan State University College of Human Medicine, 1200 E. Michigan Ave, Suite 655, Lansing, MI, 48912, USA.'}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'McLeod', 'Affiliation': 'Department of Surgery, Michigan State University College of Human Medicine, 1200 E. Michigan Ave, Suite 655, Lansing, MI, 48912, USA.'}, {'ForeName': 'Elahé T', 'Initials': 'ET', 'LastName': 'Crockett', 'Affiliation': 'Department of Medicine, Michigan State University College of Human Medicine, East Lansing, MI, 48824, USA.'}, {'ForeName': 'Srinivas', 'Initials': 'S', 'LastName': 'Kavuturu', 'Affiliation': 'Department of Surgery, Michigan State University College of Human Medicine, 1200 E. Michigan Ave, Suite 655, Lansing, MI, 48912, USA. Srinivas.Kavuturu@hc.msu.edu.'}]",Surgical endoscopy,['10.1007/s00464-019-06766-2']
384,30391434,Rectal Indomethacin and Spraying of Duodenal Papilla With Epinephrine Increases Risk of Pancreatitis Following Endoscopic Retrograde Cholangiopancreatography.,"BACKGROUND & AIMS


Rectal indomethacin and spraying of the duodenal papilla with epinephrine might reduce the incidence of pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP). We performed a randomized trial to compare the effects of the combination of indomethacin and epinephrine (IE) vs indomethacin plus saline (IS) in prophylaxis of post-ERCP pancreatitis (PEP).
METHODS


We performed a double-blind trial at 10 centers in China, from February 2017 to October 2017, of 1158 patients with native papilla undergoing ERCP. The patients were assigned randomly to groups given IE (n = 576) or IS (n = 582). All patients received a single dose of rectal indomethacin within 30 minutes before ERCP; 20 mL of dilute epinephrine (IE group) or saline (IS group) then was sprayed on the duodenal papilla at the end of ERCP. The primary outcome was the incidence of overall PEP. Data were analyzed on an intention-to-treat principle.
RESULTS


The study was terminated at the interim analysis for safety concerns and futility. The groups had similar baseline characteristics. PEP developed in 49 patients in the IE group (8.5%) and in 31 patients in the IS group (5.3%) (relative risk, 1.60, 95% CI, 1.03-2.47; P = .033). There were no significant differences between groups in proportions of patients with postsphincterotomy bleeding (2.1% in the IE group and 1.5% in the IS group) and biliary infection (1.2% in the IE group and 2.2% in the IS group).
CONCLUSIONS


In a randomized trial, we found the combination of rectal indomethacin with papillary epinephrine spraying increased the risk of PEP compared with indomethacin alone. Spray epinephrine should not be used with rectal indomethacin for prevention of post-ERCP pancreatitis. ClincialTrials.gov no: NCT03057769.",2019,"PEP developed in 49 patients in the IE group (8.5%) and in 31 patients in the IS group (5.3%) (relative risk, 1.60, 95% CI, 1.03-2.47; P = .033).","['Pancreatitis Following Endoscopic Retrograde Cholangiopancreatography', '10 centers in China, from February 2017 to October 2017, of 1158 patients with native papilla undergoing ERCP', 'pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP']","['Spray epinephrine', 'epinephrine', 'dilute epinephrine (IE group) or saline', 'Epinephrine', 'Rectal Indomethacin', 'indomethacin', 'rectal indomethacin', 'indomethacin and epinephrine (IE) vs indomethacin plus saline (IS']","['postsphincterotomy bleeding', 'incidence of overall PEP', 'risk of PEP', 'biliary infection', 'PEP']","[{'cui': 'C0030305', 'cui_str': 'Pancreatitis'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0008310', 'cui_str': 'ERCP'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0302891', 'cui_str': 'Native (qualifier value)'}]","[{'cui': 'C4521772', 'cui_str': 'Spray'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C1720119', 'cui_str': 'Dilute'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0205052', 'cui_str': 'Rectal (qualifier value)'}, {'cui': 'C0021246', 'cui_str': 'Indomethacin'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0359587', 'cui_str': 'Peptamen'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C3714514', 'cui_str': 'Infection'}]",1158.0,0.2964,"PEP developed in 49 patients in the IE group (8.5%) and in 31 patients in the IS group (5.3%) (relative risk, 1.60, 95% CI, 1.03-2.47; P = .033).","[{'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Luo', 'Affiliation': ""State Key Laboratory of Cancer Biology, National Clinical Research Center for Digestive Diseases, Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Xiangping', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""State Key Laboratory of Cancer Biology, National Clinical Research Center for Digestive Diseases, Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Rongchun', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': ""State Key Laboratory of Cancer Biology, National Clinical Research Center for Digestive Diseases, Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Shuhui', 'Initials': 'S', 'LastName': 'Liang', 'Affiliation': ""State Key Laboratory of Cancer Biology, National Clinical Research Center for Digestive Diseases, Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Xiaoyu', 'Initials': 'X', 'LastName': 'Kang', 'Affiliation': ""State Key Laboratory of Cancer Biology, National Clinical Research Center for Digestive Diseases, Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Xiaofeng', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ""Department of Gastroenterology, Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine, Hangzhou, China.""}, {'ForeName': 'Qifeng', 'Initials': 'Q', 'LastName': 'Lou', 'Affiliation': ""Department of Gastroenterology, Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine, Hangzhou, China.""}, {'ForeName': 'Kangwei', 'Initials': 'K', 'LastName': 'Xiong', 'Affiliation': ""Department of Gastroenterology, Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine, Hangzhou, China.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': ""Department of Gastroenterology, Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine, Hangzhou, China.""}, {'ForeName': 'Lijuan', 'Initials': 'L', 'LastName': 'Si', 'Affiliation': 'Department of Gastroenterology, Zhongshan Hospital of Xiamen University, Xiamen, China.'}, {'ForeName': 'Wenming', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'Department of Gastroenterology, Zhongshan Hospital of Xiamen University, Xiamen, China.'}, {'ForeName': 'Yunpeng', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Gastroenterology, Zhongshan Hospital of Xiamen University, Xiamen, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': ""Department of Gastroenterology, No 451 Military Hospital, Xi'an, China.""}, {'ForeName': 'Suli', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': ""Department of Gastroenterology, No 451 Military Hospital, Xi'an, China.""}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Yang', 'Affiliation': ""Department of Gastroenterology, No 451 Military Hospital, Xi'an, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'Department of Gastroenterology, The First Affiliated Hospital of the Medical College, Shihezi University, Shihezi, China.'}, {'ForeName': 'Yanzhi', 'Initials': 'Y', 'LastName': 'Han', 'Affiliation': 'Department of Gastroenterology, The First Affiliated Hospital of the Medical College, Shihezi University, Shihezi, China.'}, {'ForeName': 'Guochen', 'Initials': 'G', 'LastName': 'Shang', 'Affiliation': 'Department of Gastroenterology, The First Affiliated Hospital of the Medical College, Shihezi University, Shihezi, China.'}, {'ForeName': 'Xiaocui', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Endoscopy Center, Ankang Central Hospital, Ankang, China.'}, {'ForeName': 'Yongfeng', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': 'Endoscopy Center, Ankang Central Hospital, Ankang, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Zou', 'Affiliation': 'Endoscopy Center, Ankang Central Hospital, Ankang, China.'}, {'ForeName': 'Wenwei', 'Initials': 'W', 'LastName': 'Guo', 'Affiliation': 'Endoscopy Center, Ankang Central Hospital, Ankang, China.'}, {'ForeName': 'Yichen', 'Initials': 'Y', 'LastName': 'Dai', 'Affiliation': 'Department of Gastroenterology, Chenggong Hospital of Xiamen University, Xiamen, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zeng', 'Affiliation': 'Department of Gastroenterology, Chenggong Hospital of Xiamen University, Xiamen, China.'}, {'ForeName': 'Xiaosan', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Department of Gastroenterology, Chenggong Hospital of Xiamen University, Xiamen, China.'}, {'ForeName': 'Rongqing', 'Initials': 'R', 'LastName': 'Gong', 'Affiliation': 'Department of Gastroenterology, Chenggong Hospital of Xiamen University, Xiamen, China.'}, {'ForeName': 'Xun', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'The Second Department of General Surgery, The First Hospital of Lanzhou University, Lanzhou, China.'}, {'ForeName': 'Zhanguo', 'Initials': 'Z', 'LastName': 'Nie', 'Affiliation': 'Department of Gastroenterology, Urumqi General Hospital of Lanzhou Military Region, Urumqi, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Department of Hepatobiliary Surgery, General Hospital of Ningxia Medical University, Yinchuan, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': ""Department of Health Statistics, Fourth Military Medical University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Yanglin', 'Initials': 'Y', 'LastName': 'Pan', 'Affiliation': ""State Key Laboratory of Cancer Biology, National Clinical Research Center for Digestive Diseases, Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, Shaanxi, China. Electronic address: yanglinpan@hotmail.com.""}, {'ForeName': 'Xuegang', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': ""State Key Laboratory of Cancer Biology, National Clinical Research Center for Digestive Diseases, Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, Shaanxi, China. Electronic address: xuegangguo@gmail.com.""}, {'ForeName': 'Daiming', 'Initials': 'D', 'LastName': 'Fan', 'Affiliation': ""State Key Laboratory of Cancer Biology, National Clinical Research Center for Digestive Diseases, Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, Shaanxi, China.""}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2018.10.043']
385,30476584,"Safety of Tofacitinib for Treatment of Ulcerative Colitis, Based on 4.4 Years of Data From Global Clinical Trials.","BACKGROUND & AIMS


Tofacitinib is an oral, small-molecule inhibitor of JAK approved in several countries for the treatment of ulcerative colitis (UC). We report integrated safety analyses of tofacitinib-treated patients with moderate to severe UC.
METHODS


Patients receiving placebo or tofacitinib (5 or 10 mg) twice daily were analyzed as 3 cohorts: induction (phase 2 and 3 induction studies, n = 1220), maintenance (phase 3 maintenance study, n = 592), and overall (patients receiving tofacitinib 5 or 10 mg twice daily in phase 2, phase 3, or open-label, long-term extension studies, n = 1157; 1613 patient-years' exposure). Incidence rates (IRs; patients with events per 100 patient-years of exposure) were evaluated for select adverse events.
RESULTS


In the maintenance cohort, IRs for select adverse events were similar among treatment groups, except for a numerically higher IR of herpes zoster infection among patients who received tofacitinib 5 mg twice daily (2.1; 95% CI, 0.4-6.0) and statistically higher IR among patients who received tofacitinib 10 mg twice daily (IR, 6.6; 95% CI, 3.2-12.2) vs placebo (IR, 1.0, 95% CI, 0.0-5.4). For the overall cohort (84% received average dose of tofacitinib 10 mg twice daily), IRs were: death, 0.2 (95% CI, 0.1-0.6); serious infections, 2.0 (95% CI, 1.4-2.8); opportunistic infections, 1.3 (95% CI, 0.8-2.0); herpes zoster infection, 4.1 (95% CI, 3.1-5.2); malignancy (excluding non-melanoma skin cancer), 0.7 (95% CI, 0.3-1.2); non-melanoma skin cancer, 0.7 (95% CI, 0.3-1.2); major adverse cardiovascular events, 0.2 (95% CI, 0.1-0.6); and gastrointestinal perforations, 0.2 (95% CI, 0.0-0.5).
CONCLUSIONS


In safety analyses of patients with moderate to severe UC treated with tofacitinib, we observed a dose relationship with herpes zoster infection. Although follow-up time was relatively short, the safety profile of tofacitinib for patients with UC appeared similar to that reported for patients with rheumatoid arthritis and for patients with UC treated with biologic agents, except for the higher IR of herpes zoster infection. ClinicalTrials.gov, no: NCT00787202, NCT01465763, NCT01458951, NCT01458574, and NCT01470612.",2019,"In the maintenance cohort, IRs for select adverse events were similar among treatment groups, except for a numerically higher IR of herpes zoster infection among patients who received tofacitinib 5 mg twice daily (2.1; 95% CI, 0.4-6.0) and statistically higher IR among patients who received tofacitinib 10 mg twice daily (IR, 6.6; 95% CI, 3.2-12.2) vs placebo (IR, 1.0, 95% CI, 0.0-5.4).","['patients with moderate to severe UC treated with', '5 or 10 mg) twice daily were analyzed as 3 cohorts: induction (phase 2 and 3 induction studies, n\xa0= 1220), maintenance (phase 3 maintenance study, n\xa0= 592), and overall (patients receiving', 'treated patients with moderate to severe UC', 'Patients receiving']","['tofacitinib 5 or 10 mg twice daily in phase 2, phase 3, or open-label, long-term extension studies', 'tofacitinib', 'placebo', 'placebo or tofacitinib', 'Tofacitinib']","['serious infections', 'Incidence rates', 'herpes zoster infection', 'gastrointestinal perforations', 'adverse cardiovascular events', 'opportunistic infections']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0297096', 'cui_str': 'arsenotriglutathione'}, {'cui': 'C0439560', 'cui_str': 'Phase 2 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0439561', 'cui_str': 'Phase 3 (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C2930696', 'cui_str': 'tofacitinib'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0439560', 'cui_str': 'Phase 2 (qualifier value)'}, {'cui': 'C0439561', 'cui_str': 'Phase 3 (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0019360', 'cui_str': 'Shingles'}, {'cui': 'C1963976', 'cui_str': 'Gastrointestinal perforation (SMQ)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0029118', 'cui_str': 'Opportunistic Infections'}]",,0.374068,"In the maintenance cohort, IRs for select adverse events were similar among treatment groups, except for a numerically higher IR of herpes zoster infection among patients who received tofacitinib 5 mg twice daily (2.1; 95% CI, 0.4-6.0) and statistically higher IR among patients who received tofacitinib 10 mg twice daily (IR, 6.6; 95% CI, 3.2-12.2) vs placebo (IR, 1.0, 95% CI, 0.0-5.4).","[{'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Sandborn', 'Affiliation': 'Division of Gastroenterology, University of California, San Diego, La Jolla, California. Electronic address: wsandborn@ucsd.edu.'}, {'ForeName': 'Julián', 'Initials': 'J', 'LastName': 'Panés', 'Affiliation': 'Inflammatory Bowel Diseases Unit, Hospital Clínic de Barcelona, IDIBAPS, CIBERehd, Barcelona, Spain.'}, {'ForeName': 'Geert R', 'Initials': 'GR', 'LastName': ""D'Haens"", 'Affiliation': 'Department of Gastroenterology, Academic Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Bruce E', 'Initials': 'BE', 'LastName': 'Sands', 'Affiliation': 'Dr Henry D Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Chinyu', 'Initials': 'C', 'LastName': 'Su', 'Affiliation': 'Pfizer Inc, Collegeville, Pennsylvania.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Moscariello', 'Affiliation': 'Pfizer Inc, Collegeville, Pennsylvania.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Jones', 'Affiliation': 'Pfizer Inc, Collegeville, Pennsylvania.'}, {'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Pedersen', 'Affiliation': 'Pfizer Inc, Collegeville, Pennsylvania.'}, {'ForeName': 'Gary S', 'Initials': 'GS', 'LastName': 'Friedman', 'Affiliation': 'Pfizer Inc, Collegeville, Pennsylvania.'}, {'ForeName': 'Nervin', 'Initials': 'N', 'LastName': 'Lawendy', 'Affiliation': 'Pfizer Inc, Collegeville, Pennsylvania.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Chan', 'Affiliation': 'Pfizer Inc, Collegeville, Pennsylvania.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2018.11.035']
386,31633789,Opioid Exposure Negatively Affects Antidepressant Response to Venlafaxine in Older Adults with Chronic Low Back Pain and Depression.,"OBJECTIVE


Serotonin norepinephrine reuptake inhibitors (SNRIs) are commonly co-prescribed with opioids for chronic pain. The purpose of this study was to describe pain and mood response to venlafaxine among older adults with chronic low back pain (CLBP) and depression relative to opioid exposure.
DESIGN


Secondary analyses were collected from a randomized clinical trial testing a stepped-care approach to comorbid pain and depression in older patients: the Addressing Depression and Pain Together study (ADAPT: 2010-2016).
SETTING


University-based late-life mental health research clinic.
SUBJECTS


Two hundred twenty-seven adults aged 65+ years with CLBP and depression.
METHODS


Participants received six weeks of lower-dose venlafaxine (≤150 mg/d). Pain and depression were measured each week. Response for both pain and depression at the end of six weeks was defined by a ≥30% improvement on a 0-20 numeric rating scale for low back pain and a Patient Health Questionnaire-9 score ≤5. Opioid exposure was analyzed as prescribed (yes or no) and by morphine equivalent dosing (MED).
RESULTS


Patients co-prescribed an opioid were less likely to report a pain response to venlafaxine. MED was negatively correlated with pain response. Depression response was not impacted.
CONCLUSIONS


Opioids are negatively associated with older adults' early analgesic response to lower-dose venlafaxine. These findings suggest that clinicians may wish to consider either nonopioid or alternative antidepressant approaches to pain management in these complex patients. It is reassuring that opioids do not prevent depression response. Future research should examine both longer duration of treatment and a wider range of doses.",2020,"Depression response was not impacted.
","['Two hundred twenty-seven adults aged 65+ years with CLBP and depression', 'Older Adults with Chronic Low Back Pain and Depression', 'older adults with chronic low back pain (CLBP) and depression relative to opioid exposure', 'University-based late-life mental health research clinic', 'older patients']","['Serotonin norepinephrine reuptake inhibitors (SNRIs', 'venlafaxine', 'nonopioid', 'morphine equivalent dosing (MED', 'stepped-care approach', 'Venlafaxine']","['pain and mood response', 'analgesic response', 'pain response', 'Pain and depression', 'Depression response']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain (finding)'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0035168'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C4521489', 'cui_str': 'Norepinephrine reuptake inhibitor (disposition)'}, {'cui': 'C0078569', 'cui_str': 'venlafaxine'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]",227.0,0.102578,"Depression response was not impacted.
","[{'ForeName': 'Sarah T', 'Initials': 'ST', 'LastName': 'Stahl', 'Affiliation': 'Departments of Psychiatry.'}, {'ForeName': 'Changgi', 'Initials': 'C', 'LastName': 'Jung', 'Affiliation': 'Departments of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Debra K', 'Initials': 'DK', 'LastName': 'Weiner', 'Affiliation': 'Departments of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Peciña', 'Affiliation': 'Departments of Psychiatry.'}, {'ForeName': 'Jordan F', 'Initials': 'JF', 'LastName': 'Karp', 'Affiliation': 'Departments of Psychiatry.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnz279']
387,31585966,Preventing depression in the community by voluntary sector providers (PERSUADE): intervention development and protocol for a parallel randomised controlled feasibility trial.,"INTRODUCTION


Depression is now the most common illness worldwide affecting more than 300 million people. Studies modelling the impact of depression interventions have shown that the burden of depression cannot be minimised by more than 35% with existing treatments. There is a need to develop better preventative interventions. The overall aim of this programme of work is to develop interventions to reduce depression symptom scores and prevent development of depression in people with subthreshold depression. The objectives are to adapt a low intensity community-based depression prevention intervention, establish the acceptability and uptake of this model and conduct a parallel randomised controlled feasibility trial to inform a full-scale trial.
METHODS AND ANALYSIS


Focus groups will be run with members of the public, voluntary sector providers and researchers to inform the adaptation of an existing depression prevention course. Sixty-four people with subthreshold depression, as represented by a score of between 5 and 9 on the Patient Health Questionnaire-9 depression measure, will be recruited to take part in the feasibility trial. Participants will be randomised equally to the intervention or usual care control groups. Participants in the intervention group will receive the new revised manual and attend a 1-day workshop delivered by voluntary sector service providers. Outcome measures will be completed 3 months after baseline. Quantitative data on recruitment, randomisation, attendance, retention, questionnaire completion rates will be collected. Primary analyses will be descriptive and a process evaluation will be conducted to assess the processes involved in implementing the intervention. Interviews will be conducted to explore acceptability and framework analysis will be used to analyse the data.
ETHICS AND DISSEMINATION


The study has been reviewed and approved by NHS Research and Ethics Committee: NW-Greater Manchester East. The results will be actively disseminated through peer-reviewed journals, conference presentations, social media, the internet and community engagement activities.
TRIAL REGISTRATION NUMBER


ISRCTN23278208;Pre-results.",2019,Studies modelling the impact of depression interventions have shown that the burden of depression cannot be minimised by more than 35% with existing treatments.,"['Focus groups will be run with members of the public, voluntary sector providers and researchers to inform the adaptation of an existing depression prevention course', 'Sixty-four people with subthreshold depression, as represented by a score of between 5 and 9 on the Patient Health Questionnaire-9 depression measure, will be recruited to take part in the feasibility trial', 'people with subthreshold depression']",['new revised manual and attend a 1-day workshop delivered by voluntary sector service providers'],"['depression symptom scores', 'Quantitative data on recruitment, randomisation, attendance, retention, questionnaire completion rates']","[{'cui': 'C0016400', 'cui_str': 'Focus Groups'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C0680022', 'cui_str': 'Member of (attribute)'}, {'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0700287', 'cui_str': 'Informing (procedure)'}, {'cui': 'C0392673', 'cui_str': 'Adaptation, function (observable entity)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]","[{'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",64.0,0.176076,Studies modelling the impact of depression interventions have shown that the burden of depression cannot be minimised by more than 35% with existing treatments.,"[{'ForeName': 'Cassandra', 'Initials': 'C', 'LastName': 'Kenning', 'Affiliation': 'Division of Population Health, Health Services Research and Primary Care, University of Manchester, Manchester, Greater Manchester, UK.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Blakemore', 'Affiliation': 'Division of Nursing, Midwifery and Social Work, University of Manchester, Manchester, Manchester, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bower', 'Affiliation': 'Division of Population Health, Health Services Research and Primary Care, University of Manchester, Manchester, Greater Manchester, UK.'}, {'ForeName': 'Melina', 'Initials': 'M', 'LastName': 'Safari', 'Affiliation': 'Division of Population Health, Health Services Research and Primary Care, University of Manchester, Manchester, Greater Manchester, UK.'}, {'ForeName': 'Pim', 'Initials': 'P', 'LastName': 'Cuijpers', 'Affiliation': 'Faculty of Behaviour and Movement Sciences, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'June Sl', 'Initials': 'JS', 'LastName': 'Brown', 'Affiliation': 'Department of Psychology, Kings College London, London, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Hann', 'Affiliation': 'Centre for Biostatistics and Manchester Academic Health Science Centre, University of Manchester, Manchester, UK.'}, {'ForeName': 'Nicky', 'Initials': 'N', 'LastName': 'Lidbetter', 'Affiliation': 'Self Help Services, Manchester, UK.'}, {'ForeName': 'Ricardo F', 'Initials': 'RF', 'LastName': 'Muñoz', 'Affiliation': 'Institute for International Internet Interventions for Health, Palo Alto University, Palo Alto, California, USA.'}, {'ForeName': 'Waquas', 'Initials': 'W', 'LastName': 'Waheed', 'Affiliation': 'Division of Population Health, Health Services Research and Primary Care, University of Manchester, Manchester, Greater Manchester, UK.'}]",BMJ open,['10.1136/bmjopen-2018-023791']
388,31585976,Questionnaire survey on women's views after a first caesarean delivery in two tertiary centres in Ireland and their preference for involvement in a future randomised trial on mode of birth.,"OBJECTIVE


To assess the views of women after a first caesarean section (CS) on their birth experience, preference for future mode of birth and willingness to participate in a randomised controlled trial on mode of birth in a future pregnancy.
DESIGN


Questionnaire survey.
SETTING


Two tertiary maternity centres Ireland, Galway University Hospital, Galwayand the National Maternity Hospital, Dublin.
PARTICIPANTS


Women with one previous CS.
METHODS


Eligible women consented to participate, and postal surveys were forwarded. Results were collected and analysed. Results were compared between women who had elective operations and women who had emergency operations.
PRIMARY OUTCOME MEASURES


The satisfaction levels of women after a first caesarean, their preference for mode of birth in a future pregnancy and their willingness to participate in a randomised trial on mode of birth.
RESULTS


There were 347 completed surveys of 633 women who consented to participate (54.8%), of whom 285 and 62 had emergency and elective caesarean deliveries, respectively. In general, satisfaction ratings with the delivery were greater than 90%, with similar levels of satisfaction with the care received from doctors and midwives. Women who an emergency procedure expressed lower satisfaction levels with the information about the caesarean and the debriefing received afterwards than women who had a planned operation (p<0.05). For future mode of birth, 39.5% expressed a preference for vaginal birth after caesarean (VBAC) in a subsequent pregnancy, and 80% said they would consider involvement in a randomised trial in a future pregnancy.
CONCLUSION


Debriefing and counselling women after a CS is an important part of pregnancy care and can significantly impact on a woman's overall birth experience. A significant proportion of this cohort considered VBAC as a future birth option. These data indicate that a randomised trial on mode of birth after caesarean would be viewed positively by women in our population.",2019,Women who an emergency procedure expressed lower satisfaction levels with the information about the caesarean and the debriefing received afterwards than women who had a planned operation (p<0.05).,"['Two tertiary maternity centres', '347 completed surveys of 633 women who consented to participate (54.8%), of whom 285 and 62 had emergency and elective caesarean deliveries, respectively', 'Women with one previous CS', 'women who had elective operations and women who had emergency operations', 'Eligible women consented to participate, and postal surveys were forwarded']",['caesarean section (CS'],['satisfaction levels'],"[{'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0175673', 'cui_str': 'Emergency (qualifier value)'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0184893', 'cui_str': 'Emergency operation'}, {'cui': 'C0439780', 'cui_str': 'Forward (qualifier value)'}]","[{'cui': 'C0007876', 'cui_str': 'C-Section (OB)'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",633.0,0.0694985,Women who an emergency procedure expressed lower satisfaction levels with the information about the caesarean and the debriefing received afterwards than women who had a planned operation (p<0.05).,"[{'ForeName': 'Gillian', 'Initials': 'G', 'LastName': 'Ryan', 'Affiliation': 'Department of Obstetrics and Gynaecology, National University of Ireland, Galway, Ireland gillian.ryan@nuigalway.ie.'}, {'ForeName': 'Kate C', 'Initials': 'KC', 'LastName': 'O Doherty', 'Affiliation': 'Obstetrics and Gynaecology, National Maternity Hospital, Dublin, Ireland.'}, {'ForeName': 'Declan', 'Initials': 'D', 'LastName': 'Devane', 'Affiliation': 'School of Nursing and Midwifery, National University Of Ireland, Galway, Ireland.'}, {'ForeName': 'Fionnuala', 'Initials': 'F', 'LastName': 'McAuliffe', 'Affiliation': 'Obstetrics and Gynaecology, National Maternity Hospital, Dublin, Ireland.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Morrison', 'Affiliation': 'Department of Obstetrics and Gynaecology, National University of Ireland, Galway, Ireland.'}]",BMJ open,['10.1136/bmjopen-2019-031766']
389,31585978,Feasibility of a 6-month pilot randomised controlled trial of resistance training on cognition and brain health in Canadian older adults at-risk for diabetes: study protocol.,"INTRODUCTION


Type 2 diabetes (T2D) is associated with cognitive deficits and increased risk of dementia, and thus individuals at high risk for T2D (ie, those who are overweight or prediabetic) are also at greater risk for cognitive decline. Aerobic exercise is known to preserve and improve cognitive function, but the effects of resistance training (RT) are much less known in older adults. Moreover, research on the effects of RT on cognition and brain health (structure and function) in older adults at-risk for diabetes is limited. To address this question, a 6-month RT intervention is needed. Importantly, before conducting a full-scale randomised controlled trial (RCT), we are conducting a feasibility pilot study to assess potential recruitment rates, adherence and retention in this specific population.
METHODS AND ANALYSIS


We are conducting a 6-month, thrice-weekly RT RCT. Participants (aged 60-80; sedentary; fasting plasma glucose of 6.1-7.0 mmol/L or body mass index ≥25) are randomised into one of two groups: (1) RT or (2) balance and tone (control). Based on other exercise trials using a similar population, we will consider our trial feasible if we have adherence and retention at 70%. Recruitment rate will be measured as time it takes to enrol 20 participants. To assess behavioural and MRI data, we will report descriptive statistics and estimation using a 95% CI.
ETHICS AND DISSEMINATION


Our study has received ethics approval from the Health Sciences Research Ethics Board at Western University. As this is a small pilot study, data will only be made available to other researchers on request. Results from this study will be disseminated via academic publication.
TRIAL REGISTRATION NUMBER


NCT03254381.",2019,Participants (aged 60-80; sedentary; fasting plasma glucose of 6.1-7.0 mmol/L or body mass index ≥25) are randomised into one of two groups: (1) RT or (2) balance and tone (control).,"['Participants (aged 60-80; sedentary; fasting plasma glucose of 6.1-7.0\u2009mmol/L or body mass index ≥25', 'older adults at-risk for diabetes', 'Canadian older adults at-risk for diabetes', 'older adults']","['Aerobic exercise', 'resistance training (RT', 'resistance training', 'RT']","['cognitive function', 'cognition and brain health', 'cognition and brain health (structure and function']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C1532563', 'cui_str': 'umol/mL'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}]","[{'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0031843', 'cui_str': 'function'}]",20.0,0.157442,Participants (aged 60-80; sedentary; fasting plasma glucose of 6.1-7.0 mmol/L or body mass index ≥25) are randomised into one of two groups: (1) RT or (2) balance and tone (control).,"[{'ForeName': 'Joyla A', 'Initials': 'JA', 'LastName': 'Furlano', 'Affiliation': 'Neuroscience, Western University, London, Ontario, Canada.'}, {'ForeName': 'Lindsay S', 'Initials': 'LS', 'LastName': 'Nagamatsu', 'Affiliation': 'Kinesiology, Western University, London, Ontario, Canada lindsay.nagamatsu@uwo.ca.'}]",BMJ open,['10.1136/bmjopen-2019-032047']
390,31340979,High-Dose Rituximab and Early Remission in PLA2R1-Related Membranous Nephropathy.,"BACKGROUND AND OBJECTIVES


Different rituximab protocols are used to treat membranous nephropathy. We compared two rituximab protocols in patients with membranous nephropathy.
DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS


Twenty-eight participants from the NICE cohort received two infusions of 1-g rituximab at 2-week intervals, whereas 27 participants from the Prospective Randomized Multicentric Open Label Study to Evaluate Rituximab Treatment for Membranous Nephropathy (GEMRITUX) cohort received two infusions of 375 mg/m 2  at 1-week interval. We measured serum rituximab levels and compared remission at month 6 and before any treatment modification and analyzed factors associated with remission and relapses.
RESULTS


Remissions occurred in 18 (64%) versus eight (30%) from the NICE and GEMRITUX cohort ( P =0.02) at month 6, respectively, and in 24 (86%) versus 18 (67%) participants ( P =0.12) before treatment modification, respectively. Median time to remission was 3 [interquartile range (IQR), 3-9] and 9 [IQR, 6-12] months for NICE and GEMRITUX cohorts respectively ( P =0.01). Participants from the NICE cohort had higher circulating level of rituximab and lower CD19 counts (3.3 µg/L [IQR, 0.0-10.8] versus 0.0 [IQR, 0.0-0.0]  P <0.001 and 0.0 [IQR, 0.0-2.0] versus 16.5 [IQR, 2.5-31.0]  P <0.001) at month 3, lower level of anti-PLA2R1 antibodies at month 6 (0.0 [IQR, 0.0-8.0] versus 8.3 [IQR, 0.0-73.5]  P =0.03). In the combined study population, lower epitope spreading at diagnosis and higher rituximab levels at month 3 were associated with remissions at month 6 (13/26 (50%) versus 22/29 (76%)  P =0.05 and 2.2 µg/ml [IQR, 0.0-10.9] versus 0.0 µg/ml [IQR, 0.0-0.0]  P <0.001 respectively). All non-spreaders entered into remission whatever the protocol. Eight of the 41 participants who reached remission had relapses. Epitope spreading at diagnosis (8/8 (100%) versus 16/33 (48%)  P =0.01) and incomplete depletion of anti-PLA2R1 antibodies at month 6 (4/8 (50%) versus 5/33 (9%)  P =0.05) were associated with relapses.
CONCLUSIONS


Our work suggests that higher dose rituximab protocol is more effective on depletion of B-cells and lack of epitope spreading is associated with remission of membranous nephropathy.",2019,"Epitope spreading at diagnosis (8/8 (100%) versus 16/33 (48%)  P =0.01) and incomplete depletion of anti-PLA2R1 antibodies at month 6 (4/8 (50%) versus 5/33 (9%)  P =0.05) were associated with relapses.
","['PLA2R1-Related Membranous Nephropathy', 'patients with membranous nephropathy', 'Twenty-eight participants from the NICE cohort received two infusions of 1-g']","['High-Dose Rituximab', 'Rituximab', 'rituximab']","['Median time to remission', 'level of anti-PLA2R1 antibodies', 'lower epitope spreading at diagnosis and higher rituximab levels', 'circulating level of rituximab and lower CD19 counts', 'incomplete depletion of anti-PLA2R1 antibodies', 'Remissions', 'serum rituximab levels']","[{'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0017665', 'cui_str': 'Membranous Glomerulonephropathy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0721912', 'cui_str': ""N'ICE""}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}]","[{'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0003316', 'cui_str': 'Antigenic Determinants'}, {'cui': 'C0332261', 'cui_str': 'Spread (attribute)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0205257', 'cui_str': 'Incomplete (qualifier value)'}, {'cui': 'C0333668', 'cui_str': 'Depletion (morphologic abnormality)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]",28.0,0.046324,"Epitope spreading at diagnosis (8/8 (100%) versus 16/33 (48%)  P =0.01) and incomplete depletion of anti-PLA2R1 antibodies at month 6 (4/8 (50%) versus 5/33 (9%)  P =0.05) were associated with relapses.
","[{'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Seitz-Polski', 'Affiliation': ""Department of Immunology, Hôpital l'Archet, Centre Hospitalier Universitaire de Nice, Université Côte d'Azur, Nice, France; seitz-polski.b@chu-nice.fr.""}, {'ForeName': 'Karine', 'Initials': 'K', 'LastName': 'Dahan', 'Affiliation': 'Department of Nephrology and Dialysis, Hôpital Tenon, Assistance Publique des Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Debiec', 'Affiliation': 'Unité Mixte de Recherche_S 1155, Institut National de la Santé et de la Recherche Médicale, Paris, France.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Rousseau', 'Affiliation': 'Department of Clinical Pharmacology and Clinical Research, Hôpital Saint Antoine, AP-HP, Paris, France.'}, {'ForeName': 'Marine', 'Initials': 'M', 'LastName': 'Andreani', 'Affiliation': ""Department of Nephrology-Dialysis-Transplantation, Hôpital Pasteur, CHU de Nice, Université Côte d'Azur, Nice, France.""}, {'ForeName': 'Christelle', 'Initials': 'C', 'LastName': 'Zaghrini', 'Affiliation': ""Institut de Pharmacologie Moléculaire et Cellulaire, Centre National de la Recherche Scientifique, Université Côte d'Azur, Nice, France.""}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Ticchioni', 'Affiliation': ""Department of Immunology, Hôpital l'Archet, Centre Hospitalier Universitaire de Nice, Université Côte d'Azur, Nice, France.""}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Rosenthal', 'Affiliation': ""Department of Immunology, Hôpital l'Archet, Centre Hospitalier Universitaire de Nice, Université Côte d'Azur, Nice, France.""}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Benzaken', 'Affiliation': ""Department of Immunology, Hôpital l'Archet, Centre Hospitalier Universitaire de Nice, Université Côte d'Azur, Nice, France.""}, {'ForeName': 'Ghislaine', 'Initials': 'G', 'LastName': 'Bernard', 'Affiliation': ""Department of Immunology, Hôpital l'Archet, Centre Hospitalier Universitaire de Nice, Université Côte d'Azur, Nice, France.""}, {'ForeName': 'Gérard', 'Initials': 'G', 'LastName': 'Lambeau', 'Affiliation': ""Institut de Pharmacologie Moléculaire et Cellulaire, Centre National de la Recherche Scientifique, Université Côte d'Azur, Nice, France.""}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Ronco', 'Affiliation': 'Department of Nephrology and Dialysis, Hôpital Tenon, Assistance Publique des Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Vincent L M', 'Initials': 'VLM', 'LastName': 'Esnault', 'Affiliation': ""Department of Nephrology-Dialysis-Transplantation, Hôpital Pasteur, CHU de Nice, Université Côte d'Azur, Nice, France.""}]",Clinical journal of the American Society of Nephrology : CJASN,['10.2215/CJN.11791018']
391,32266392,Early provision of intrauterine contraception as part of abortion care-5-year results of a randomised controlled trial.,"STUDY QUESTION


Can the incidence of subsequent termination of pregnancy (TOP) be reduced by providing intrauterine contraception as part of the abortion service?
SUMMARY ANSWER


Provision of an intrauterine device (IUD) as part of TOP services reduced the need for subsequent TOP but the effect was limited to the first 3 years of the 5-year follow-up.
WHAT IS KNOWN ALREADY


An IUD is highly effective in preventing subsequent TOP. Prompt initiation of IUD use leads to a higher usage rate during follow-up, as compliance with post-TOP IUD insertion visits is low.
STUDY DESIGN, SIZE, DURATION


The objective of this randomised controlled trial was to assess the effect of early comprehensive provision of intrauterine contraception after TOP, with primary outcome being the incidence of subsequent TOP during the 5 years of follow-up after the index abortion. This study was conducted at a tertiary care centre between 18 October 2010 and 21 January 2013. Altogether, 748 women undergoing a first trimester TOP were recruited and randomised into two groups. The intervention group (n = 375) was provided with an IUD during surgical TOP or 1-4 weeks following medical TOP at the hospital providing the abortion care. Women in the control group (n = 373) were advised to contact primary health care for follow-up and IUD insertion. Subsequent TOPs during the 5-year follow-up were identified from the Finnish Register on induced abortions.
PARTICIPANTS/MATERIALS, SETTING, METHODS


The inclusion criteria were age ≥18 years, duration of gestation ≤12 weeks, residence in Helsinki and accepting intrauterine contraception. Women with contraindications to IUD were excluded.
MAIN RESULTS AND THE ROLE OF CHANCE


The overall numbers of subsequent TOPs were 50 in the intervention and 72 in the control group (26.7 versus 38.6/1000 years of follow-up, P = 0.027), and those of requested TOPs, including TOPs and early pregnancy failures, were 58 and 76, respectively (30.9 versus 40.8/1000, P = 0.080). Altogether 40 (10.7%) women in the intervention and 63 (16.9%) in the control group underwent one or several subsequent TOPs (hazard ratio 1.67 [95% CI 1.13 to 2.49], P = 0.011). The number of TOPs was reduced by the intervention during years 0-3 (22.2 versus 46.5/1000, P = 0.035), but not during years 4-5 (33.3 versus 26.8/1000, P = 0.631).
LIMITATIONS, REASONS FOR CAUTION


Both medical and surgical TOP were used. This may be seen as a limitation, but it also reflects the contemporary practice of abortion care. The immediate post-TOP care was provided by two different organizations, allowing us to compare two different ways of contraceptive service provision following TOP.
WIDER IMPLICATIONS OF THE FINDINGS


Providing TOP and IUD insertion comprehensively in the same heath care unit leads to significantly higher rates of attendance, IUD use and a significantly lower risk of subsequent TOP.
STUDY FUNDING/COMPETING INTEREST(S)


This study was supported by Helsinki University Central Hospital Research funds and by research grants provided by the Jenny and Antti Wihuri Foundation, the Yrjö Jahnsson Foundation and Finska Läkaresällskapet. E.P. has received a personal research grant from the Finnish Medical Society. The City of Helsinki supported the study by providing the IUDs. The funding organisations had no role in planning or execution of the study, or in analysing the study results.
TRIAL REGISTRATION NUMBER


The trial was registered at clinicaltrials.gov (NCT01223521).
TRIAL REGISTRATION DATE


18 October 2010.
DATE OF FIRST PATIENT’S ENROLMENT


18 October 2010.",2020,"The number of TOPs was reduced by the intervention during years 0-3 (22.2 versus 46.5/1000, P = 0.035), but not during years 4-5 (33.3 versus 26.8/1000, P = 0.631).
","['Women in the control group (n\xa0', 'The inclusion criteria were age ≥18\xa0years, duration of gestation ≤12\xa0weeks, residence in Helsinki and accepting intrauterine contraception', '18 October 2010', '748 women undergoing a first trimester TOP', '’S ENROLMENT\n\n\n18 October 2010', 'Women with contraindications to IUD were excluded', 'tertiary care centre between 18 October 2010 and 21 January 2013']",['intrauterine contraception'],"['overall numbers of subsequent TOPs', 'number of TOPs', 'requested TOPs, including TOPs and early pregnancy failures']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0460089', 'cui_str': 'Finding of length of gestation'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1272684', 'cui_str': 'Accepted'}, {'cui': 'C0589595', 'cui_str': 'Intrauterine contraception'}, {'cui': 'C0032979', 'cui_str': 'First trimester pregnancy'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to'}, {'cui': 'C0015927', 'cui_str': 'Fetal death'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}]","[{'cui': 'C0589595', 'cui_str': 'Intrauterine contraception'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0243463', 'cui_str': '2,2,6,6-tetramethyl-1-oxylpiperidinyl succinic acid'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0231174', 'cui_str': 'Failure'}]",748.0,0.237196,"The number of TOPs was reduced by the intervention during years 0-3 (22.2 versus 46.5/1000, P = 0.035), but not during years 4-5 (33.3 versus 26.8/1000, P = 0.631).
","[{'ForeName': 'Elina', 'Initials': 'E', 'LastName': 'Pohjoranta', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Satu', 'Initials': 'S', 'LastName': 'Suhonen', 'Affiliation': 'Centralized Family Planning, Department of Social Services and Health Care, City of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Gissler', 'Affiliation': 'Department of Neurobiology, Care Sciences and Society, Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Pirjo', 'Initials': 'P', 'LastName': 'Ikonen', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Maarit', 'Initials': 'M', 'LastName': 'Mentula', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Oskari', 'Initials': 'O', 'LastName': 'Heikinheimo', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}]","Human reproduction (Oxford, England)",['10.1093/humrep/deaa031']
392,32001813,"The influence of polymorphisms of fat mass and obesity (FTO, rs9939609) and vitamin D receptor (VDR, BsmI, TaqI, ApaI, FokI) genes on weight loss by diet and exercise interventions in non-diabetic overweight/obese Asian Indians in North India.","OBJECTIVE


The aim of the present study was to evaluate polymorphisms of fat mass and obesity (FTO; rs9939609) and vitamin D receptor (VDR, FokI (rs2228570), BsmI (rs1544410), ApaI (rs7975232), and TaqI (rs731236)] genes on weight loss after lifestyle interventions in Asian Indians.
METHODS


In this 6-month pre-post intervention trial, 110 overweight/obese men and women underwent diet and exercise interventions for 180 days resulting in reduction in body weight, (5.1 kg, p < 0.001), waist circumference, and skinfolds.
RESULTS


Association of the following genotypes was seen in those with ≥5% weight loss: TT of FTO polymorphism; 35 (81.4%) [OR (95% CI) AT, 2.5 (0.6, 10.9); TT, 6.9 (1.6, 28.2); with reference to AA], tt of VDR TaqI polymorphism, 12 (92.3%) [OR (95% CI); tt, 32.2 (2.4, 436.4); TT, 0.5 (0.08, 3.1); all with reference to Tt], bb of VDR BsmI polymorphism; 27 (65.8%) [OR (95% CI) Bb, 0.2 (0.04, 0.9); bb, 10.6 (0.9, 120.3); all with reference to BB] after adjusting for other genotypes. Further, analysis of combined influence of genotypes conferring maximum weight loss showed that the following had high odds of ≥5% weight loss: (1) TT of FTO gene in combination with BB/Bb of VDR BsmI and TT/Tt of VDR TaqI [OR (95% CI) 5.1 (1.5, 17.4)], (2) bb of BsmI and AA/AT of FTO and tt of TaqI [OR (95% CI) 3.2 (0.3, 31.7)], and (3) bb of BsmI plus TT of FTO and tt of TaqI.
CONCLUSIONS


The above observations suggest a significant and independent role of the genotypes of FTO and VDR in influencing weight loss after lifestyle intervention in Asian Indians.",2020,"RESULTS


Association of the following genotypes was seen in those with ≥5% weight loss: TT of FTO polymorphism; 35 (81.4%)","['non-diabetic overweight/obese Asian Indians in North India', 'Asian Indians', '110 overweight/obese men and women underwent']",['diet and exercise interventions'],"['weight loss', 'fat mass and obesity (FTO; rs9939609) and vitamin D receptor (VDR, FokI (rs2228570), BsmI (rs1544410), ApaI (rs7975232), and TaqI (rs731236)] genes on weight loss', 'fat mass and obesity (FTO, rs9939609) and vitamin D receptor (VDR, BsmI, TaqI, ApaI, FokI) genes on weight loss', 'maximum weight loss']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0108082', 'cui_str': 'Cholecalciferol Receptors'}, {'cui': 'C0066198', 'cui_str': 'methyl p-azidophenyl acetimidate'}, {'cui': 'C0017337', 'cui_str': 'Genes'}]",110.0,0.11137,"RESULTS


Association of the following genotypes was seen in those with ≥5% weight loss: TT of FTO polymorphism; 35 (81.4%)","[{'ForeName': 'Seema', 'Initials': 'S', 'LastName': 'Gulati', 'Affiliation': 'Diabetes Foundation, New Delhi, India.'}, {'ForeName': 'Anoop', 'Initials': 'A', 'LastName': 'Misra', 'Affiliation': 'Diabetes Foundation, New Delhi, India. anoopmisra@gmail.com.'}, {'ForeName': 'Rajneesh', 'Initials': 'R', 'LastName': 'Tiwari', 'Affiliation': 'National Diabetes, Obesity and Cholesterol Foundation (N-DOC), New Delhi, India.'}, {'ForeName': 'Meenu', 'Initials': 'M', 'LastName': 'Sharma', 'Affiliation': 'National Diabetes, Obesity and Cholesterol Foundation (N-DOC), New Delhi, India.'}, {'ForeName': 'Ravindra M', 'Initials': 'RM', 'LastName': 'Pandey', 'Affiliation': 'All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Ashish Datt', 'Initials': 'AD', 'LastName': 'Upadhyay', 'Affiliation': 'All India Institute of Medical Sciences, New Delhi, India.'}]",European journal of clinical nutrition,['10.1038/s41430-020-0560-4']
393,32020057,"The role of appetite-related hormones, adaptive thermogenesis, perceived hunger and stress in long-term weight-loss maintenance: a mixed-methods study.","BACKGROUND/OBJECTIVES


Weight-loss maintenance is challenging, and few succeed in the long term. This study aimed to explain how appetite-related hormones, adaptive thermogenesis, perceived hunger and stress influence weight-loss maintenance.
SUBJECTS/METHODS


Fifteen adult women (age, 46.3 ± 9.5 years; BMI, 39.4 ± 4.3 kg/m 2 ) participated in a 24-month intervention, which included 3-5 months total diet replacement (825-853 kcal/d). Body weight and composition (Magnetic Resonance Imaging), resting metabolic rate (indirect calorimetry), and fasting plasma concentration of leptin, ghrelin, glucagon-like peptide-1 (GLP-1), peptide YY (PYY), and growth differentiation factor 15 (GDF-15) were measured at baseline and after weight loss, around 6 months. Perceptions relating to weight-loss maintenance were explored using qualitative interviews.
RESULTS


Mean (SD) changes in body weight (-13.8 ± 6.3 kg) and total adipose tissue (-11.5 ± 4.9 kg) were significant (P < 0.001). Weight loss was associated with a significant reduction in resting metabolic rate (-291 ± 226 kcal/day, P < 0.001) and adaptive thermogenesis (-150 ± 162 kcal/day, P = 0.003), reduction in leptin (P < 0.001) and GLP-1 (P = 0.015), an increase in ghrelin (P < 0.001), and no changes in PYY and GDF-15. Weight regain between 6 and 24 months (6.1 ± 6.3 kg, P < 0.05) was correlated positively with change in GLP-1 (r = 0.5, P = 0.037) and negatively with GLP-1 at baseline (r = -0.7, P = 0.003) and after weight loss (r = -0.7, P = 0.005). Participants did not report increased hunger after weight loss, and stress-related/emotional eating was perceived as the main reason for regain.
CONCLUSIONS


Weight regain is more likely with lower fasting GLP-1 and greater reduction in GLP-1 after weight loss, but psychological aspects of eating behaviour appear as important in attenuating weight-loss maintenance.",2020,"Weight regain between 6 and 24 months (6.1 ± 6.3 kg, P < 0.05) was correlated positively with change in GLP-1 (","['Fifteen adult women (age, 46.3\u2009±\u20099.5 years']",[],"['Weight regain', 'resting metabolic rate', 'GLP-1', 'hunger after weight loss, and stress-related/emotional eating', 'Weight loss', 'adaptive thermogenesis', 'Body weight and composition (Magnetic Resonance Imaging), resting metabolic rate (indirect calorimetry), and fasting plasma concentration of leptin, ghrelin, glucagon-like peptide-1', 'Mean (SD) changes in body weight', 'reduction in leptin', 'weight loss', 'change in GLP-1 ', 'total adipose tissue', 'GLP-1), peptide YY (PYY), and growth differentiation factor 15 (GDF-15']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517899', 'cui_str': 'Nine point five'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",[],"[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C4082350', 'cui_str': 'Resting Metabolic Rate'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C0020175', 'cui_str': 'Hunger'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C4235304', 'cui_str': 'Adaptive Thermogenesis'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0006781', 'cui_str': 'Calorimetry, Respiration'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin (substance)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0001527', 'cui_str': 'Fatty Tissue'}, {'cui': 'C0070358', 'cui_str': 'PYY Peptide'}, {'cui': 'C0668195', 'cui_str': 'Prostate Differentiation Factor'}]",15.0,0.0274015,"Weight regain between 6 and 24 months (6.1 ± 6.3 kg, P < 0.05) was correlated positively with change in GLP-1 (","[{'ForeName': 'George', 'Initials': 'G', 'LastName': 'Thom', 'Affiliation': 'Human Nutrition, School of Medicine, Dentistry and Nursing, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow Royal Infirmary, Glasgow, UK.'}, {'ForeName': 'Stephan U', 'Initials': 'SU', 'LastName': 'Dombrowski', 'Affiliation': 'Faculty of Kinesiology, University of New Brunswick, Fredericton, NB, Canada.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Brosnahan', 'Affiliation': 'Human Nutrition, School of Medicine, Dentistry and Nursing, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow Royal Infirmary, Glasgow, UK.'}, {'ForeName': 'Yasmin Y', 'Initials': 'YY', 'LastName': 'Algindan', 'Affiliation': 'Department of Clinical Nutrition, College of Applied Medical Sciences, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rosario Lopez-Gonzalez', 'Affiliation': 'Department of Radiology, Glasgow Royal Infirmary, Glasgow, UK.'}, {'ForeName': 'Giles', 'Initials': 'G', 'LastName': 'Roditi', 'Affiliation': 'Department of Radiology, Glasgow Royal Infirmary, Glasgow, UK.'}, {'ForeName': 'Michael E J', 'Initials': 'MEJ', 'LastName': 'Lean', 'Affiliation': 'Human Nutrition, School of Medicine, Dentistry and Nursing, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow Royal Infirmary, Glasgow, UK.'}, {'ForeName': 'Dalia', 'Initials': 'D', 'LastName': 'Malkova', 'Affiliation': 'Human Nutrition, School of Medicine, Dentistry and Nursing, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow Royal Infirmary, Glasgow, UK. dalia.malkova@glasgow.ac.uk.'}]",European journal of clinical nutrition,['10.1038/s41430-020-0568-9']
394,30664539,Pilot Trial of a Combined Cognitive Processing Therapy and Smoking Cessation Treatment.,"OBJECTIVE/BACKGROUND


Posttraumatic stress disorder (PTSD) and smoking are often comorbid. Combining PTSD and smoking cessation treatments could increase access to each treatment and could provide improved rates of smoking cessation through reductions in PTSD and depressive symptoms.
PARTICIPANTS


Participants were veterans with current PTSD who smoked cigarettes and were willing to initiate treatment for both problems.
METHOD


We conducted a randomized pilot trial (n = 40) to explore feasibility and estimate effect sizes of a treatment combining trauma-focused Cognitive Processing Therapy (CPT) with smoking cessation counseling and pharmacotherapy, relative to the same smoking cessation treatment without CPT.
RESULTS


Rates of bioverified 7-day point prevalence smoking abstinence at the end of treatment or at 6-month follow-up were similar across treatments. Relative to the comparison, the combined CPT and smoking cessation treatment were associated with moderate-to-large effect sizes at end of treatment for reductions in PTSD symptoms, Cohen's d = 0.718, 95% confidence interval (CI) = 0.078-1.358, that decreased by the 6-month follow-up, Cohen's d = 0.306, 95% CI = -0.334 to 0.946; and large reductions in depressive symptoms that were maintained to the 6-month follow-up, Cohen's d = 1.007, 95% CI = 0.367-1.647.
CONCLUSIONS


This pilot trial did not detect a difference in smoking cessation when combining CPT to smoking cessation treatment, relative to smoking cessation treatment without CPT. However, results suggest that combining CPT and smoking cessation treatment was associated with both reductions of psychiatric symptoms along with smoking abstinence rates similar to previous smoking cessation trials in veterans with PTSD.",2019,"This pilot trial did not detect a difference in smoking cessation when combining CPT to smoking cessation treatment, relative to smoking cessation treatment without CPT.","['veterans with PTSD', 'Participants were veterans with current PTSD who smoked cigarettes and were willing to initiate treatment for both problems']","['treatment combining trauma-focused Cognitive Processing Therapy (CPT) with smoking cessation counseling and pharmacotherapy, relative to the same smoking cessation treatment without CPT', 'Combined Cognitive Processing Therapy and Smoking Cessation Treatment']","['smoking cessation', 'depressive symptoms', 'psychiatric symptoms', 'Rates of bioverified 7-day point prevalence smoking abstinence']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0600109', 'cui_str': 'Willing (finding)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}, {'cui': 'C4521399', 'cui_str': 'LT'}]","[{'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0233401', 'cui_str': 'Psychiatric symptom (finding)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}]",,0.0238977,"This pilot trial did not detect a difference in smoking cessation when combining CPT to smoking cessation treatment, relative to smoking cessation treatment without CPT.","[{'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Dedert', 'Affiliation': 'Durham Veterans Affairs Medical Center, Durham, NC (EAD, PAD, SMW, SDM, JCB); Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC (EAD, PAR, SMW, SDM, JCP); Veterans Affairs Mid-Atlantic Region Mental Illness Research, Education, and Clinical Center, Durham, NC (EAD, PAD, SDM, JCB); Veterans Affairs Center of Innovation to Accelerate Discovery and Practice Transformation, Durham, NC (SMW).'}, {'ForeName': 'Patricia A', 'Initials': 'PA', 'LastName': 'Resick', 'Affiliation': ''}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Dennis', 'Affiliation': ''}, {'ForeName': 'Sarah M', 'Initials': 'SM', 'LastName': 'Wilson', 'Affiliation': ''}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Moore', 'Affiliation': ''}, {'ForeName': 'Jean C', 'Initials': 'JC', 'LastName': 'Beckham', 'Affiliation': ''}]",Journal of addiction medicine,['10.1097/ADM.0000000000000502']
395,31352467,Neural responses during extinction learning predict exposure therapy outcome in phobia: results from a randomized-controlled trial.,"Extinction learning is assumed to represent a core mechanism underlying exposure therapy. Empirical evaluations of this assumption, however, are largely lacking. The current study investigated whether neural activations and self-report outcomes during extinction learning and extinction recall could specifically predict exposure therapy response in specific phobia. In this double-blind randomized controlled trial, individuals with spider phobia (N = 45; female/male = 41/4) were on group basis randomly allocated to exposure therapy (n = 25; female/male = 24/1) or progressive muscle relaxation (PMR; n = 20; female/male = 17/3). Intervention effects were measured with the Fears of Spiders questionnaire. Participants also underwent a three-day fear conditioning, extinction learning, and extinction recall paradigm during functional magnetic resonance imaging at baseline. Extinction outcomes were self-reported fear and threat expectancy, and neural responses during conditioned stimulus processing and during extinction-related prediction errors (US omissions) in regions of interest (ventromedial prefrontal cortex (vmPFC) and nucleus accumbens). Results showed that exposure therapy resulted in stronger symptom reductions than PMR (Cohen's d = 0.90). Exposure therapy response was specifically predicted by prediction-error related vmPFC activation during early extinction. There were also indications vmPFC activations during conditioned safety stimulus processing at early extinction predicted therapy outcome. Neural activations during extinction recall and self-report data did however not predict therapy outcome. These findings indicate that exposure therapy may rely on neural extinction learning processes. Prediction errors are thought to drive the extinction learning process, and prediction error-related vmPFC activation specifically predicted therapy outcome. The extent to which vmPFC processes safety signals may additionally be predictive of exposure therapy response, but the specificity is less clear.",2020,Results showed that exposure therapy resulted in stronger symptom reductions than PMR (Cohen's d = 0.90).,"['specific phobia', 'n\u2009=\u200920; female/male\u2009=\u200917/3', 'individuals with spider phobia (N\u2009=\u200945; female/male\u2009=\u200941/4', 'phobia']","['exposure therapy (n\u2009=\u200925; female/male\u2009=\u200924/1) or progressive muscle relaxation (PMR', 'extinction learning and extinction recall', 'extinction learning']","['stronger symptom reductions', 'Fears of Spiders questionnaire', 'self-reported fear and threat expectancy, and neural responses during conditioned stimulus processing and during extinction-related prediction errors (US omissions) in regions of interest', 'Neural responses']","[{'cui': 'C0236801', 'cui_str': 'Phobia, Specific'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0037913', 'cui_str': 'Spiders'}, {'cui': 'C0349231', 'cui_str': 'Phobias'}]","[{'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0004361', 'cui_str': 'Progressive Relaxation'}, {'cui': 'C0015347', 'cui_str': 'Extinction (Psychology)'}]","[{'cui': 'C0442821', 'cui_str': 'Strong (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0392331', 'cui_str': 'Arachnophobia (finding)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0234404', 'cui_str': 'Conditioned stimulus, function (observable entity)'}, {'cui': 'C0015347', 'cui_str': 'Extinction (Psychology)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}]",,0.103046,Results showed that exposure therapy resulted in stronger symptom reductions than PMR (Cohen's d = 0.90).,"[{'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Lange', 'Affiliation': 'Department of Psychiatry and Psychology, School for Mental Health and Neuroscience, EURON, Maastricht University Medical Centre, Maastricht, the Netherlands. i.lange@maastrichtuniversity.nl.'}, {'ForeName': 'Liesbet', 'Initials': 'L', 'LastName': 'Goossens', 'Affiliation': 'Department of Psychiatry and Psychology, School for Mental Health and Neuroscience, EURON, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Stijn', 'Initials': 'S', 'LastName': 'Michielse', 'Affiliation': 'Department of Psychiatry and Psychology, School for Mental Health and Neuroscience, EURON, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Jindra', 'Initials': 'J', 'LastName': 'Bakker', 'Affiliation': 'Department of Psychiatry and Psychology, School for Mental Health and Neuroscience, EURON, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Bram', 'Initials': 'B', 'LastName': 'Vervliet', 'Affiliation': 'Faculty of Psychology and Educational Sciences, Laboratory of Biological Psychology, University of Leuven, Leuven, Belgium.'}, {'ForeName': 'Machteld', 'Initials': 'M', 'LastName': 'Marcelis', 'Affiliation': 'Department of Psychiatry and Psychology, School for Mental Health and Neuroscience, EURON, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Marieke', 'Initials': 'M', 'LastName': 'Wichers', 'Affiliation': 'Department of Psychiatry, Interdisciplinary Center Psychopathology and Emotion Regulation (ICPE), University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'van Os', 'Affiliation': 'Department of Psychiatry and Psychology, School for Mental Health and Neuroscience, EURON, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Therese', 'Initials': 'T', 'LastName': 'van Amelsvoort', 'Affiliation': 'Department of Psychiatry and Psychology, School for Mental Health and Neuroscience, EURON, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Koen', 'Initials': 'K', 'LastName': 'Schruers', 'Affiliation': 'Department of Psychiatry and Psychology, School for Mental Health and Neuroscience, EURON, Maastricht University Medical Centre, Maastricht, the Netherlands.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0467-8']
396,31633778,Primary Prevention of Cow's Milk Sensitization and Food Allergy by Avoiding Supplementation With Cow's Milk Formula at Birth: A Randomized Clinical Trial.,"Importance


Cow's milk formula (CMF) is used to supplement breastfeeding (BF) at birth without clear clinical evidence to support the practice.
Objective


To determine whether avoiding supplementation with CMF at birth can decrease risks of sensitization to cow's milk protein and/or clinical food allergy, including cow's milk allergy (CMA), overall and in subgroups stratified by 25-hydroxyvitamin D (25[OH]D) levels.
Design, Setting, and Participants


The Atopy Induced by Breastfeeding or Cow's Milk Formula (ABC) trial, a randomized, nonblinded clinical trial, began enrollment October 1, 2013, and completed follow-up May 31, 2018, at a single university hospital in Japan. Participants included 330 newborns at risk for atopy; of these, 312 were included in the analysis. Data were analyzed from September 1 through October 31, 2018.
Interventions


Immediately after birth, newborns were randomized (1:1 ratio) to BF with or without amino acid-based elemental formula (EF) for at least the first 3 days of life (BF/EF group) or BF supplemented with CMF (≥5 mL/d) from the first day of life to 5 months of age (BF plus CMF group).
Main Outcomes and Measures


The primary outcome was sensitization to cow's milk (IgE level, ≥0.35 allergen units [UA]/mL) at the infant's second birthday. Secondary outcomes were immediate and anaphylactic types of food allergy, including CMA, diagnosed by oral food challenge test or triggered by food ingestion, with food-specific IgE levels of at least 0.35 UA/mL. Subgroup analysis was prespecified by tertiles of serum 25(OH)D levels at 5 months of age.
Results


Of the 312 infants included in the analysis (160 female [51.3%] and 152 male [48.7%]), 151 of 156 (96.8%) in the BF/EF and BF plus CMF groups were followed up until their second birthday. The primary outcome occurred in 24 infants (16.8%) in the BF/EF group, which was significantly fewer than the 46 infants (32.2%) in the BF plus CMF group (relative risk [RR], 0.52; 95% CI, 0.34-0.81). The middle tertile of the 25(OH)D subgroup, but not the low and high tertiles, had a significant interaction with the intervention (RR, 0.19; 95% CI, 0.07-0.50; P = .02). The prevalence of food allergy at the second birthday was significantly lower in the BF/EF than in the BF plus CMF groups for immediate (4 [2.6%] vs 20 [13.2%]; RR, 0.20; 95% CI, 0.07-0.57) and anaphylactic (1 [0.7%] vs 13 [8.6%]; RR, 0.08; 95% CI, 0.01-0.58) types.
Conclusions and Relevance


The evidence suggests that sensitization to cow's milk and food allergy, including CMA and anaphylaxis, are primarily preventable by avoiding CMF supplementation for at least the first 3 days of life.
Trial Registration


http://umin.ac.jp Identifier: UMIN000011577.",2019,"The prevalence of food allergy at the second birthday was significantly lower in the BF/EF than in the BF plus CMF groups for immediate (4 [2.6%] vs 20 [13.2%]; RR, 0.20; 95% CI, 0.07-0.57) and anaphylactic (1 [0.7%] vs 13 [8.6%]; RR, 0.08; 95% CI, 0.01-0.58) types.
Conclusions and Relevance


","[""Cow's Milk Sensitization and Food Allergy by Avoiding Supplementation With Cow's Milk Formula at Birth"", ""Participants\n\n\nThe Atopy Induced by Breastfeeding or Cow's Milk Formula (ABC) trial, a randomized, nonblinded clinical trial, began enrollment October 1, 2013, and completed follow-up May 31, 2018, at a single university hospital in Japan"", '312 infants included in the analysis (160 female [51.3%] and 152 male [48.7', 'Participants included 330 newborns at risk for atopy; of these, 312 were included in the analysis']","[""Importance\n\n\nCow's milk formula (CMF"", 'BF supplemented with CMF', 'BF with or without amino acid-based elemental formula (EF']","['prevalence of food allergy', 'immediate and anaphylactic types of food allergy, including CMA, diagnosed by oral food challenge test or triggered by food ingestion, with food-specific IgE levels', ""sensitization to cow's milk (IgE level, ≥0.35 allergen units [UA]/mL) at the infant's second birthday"", 'anaphylactic', '25-hydroxyvitamin D (25[OH]D) levels', 'serum 25(OH)D levels']","[{'cui': 'C0349374', 'cui_str': ""Cow's milk (substance)""}, {'cui': 'C1325847', 'cui_str': 'Sensitization'}, {'cui': 'C0016470', 'cui_str': 'Food Allergy'}, {'cui': 'C1744681', 'cui_str': 'Congenital (qualifier value)'}, {'cui': 'C0392707', 'cui_str': 'Atopy (disorder)'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C4517706', 'cui_str': '312 (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C4517719', 'cui_str': '330 (qualifier value)'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C1444641', 'cui_str': 'At risk'}]","[{'cui': 'C0349374', 'cui_str': ""Cow's milk (substance)""}, {'cui': 'C0768190', 'cui_str': 'CMF (protein)'}, {'cui': 'C3539946', 'cui_str': 'Amino acids'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3853260', 'cui_str': 'Elemental formula'}]","[{'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0016470', 'cui_str': 'Food Allergy'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0449492', 'cui_str': 'Type of food (attribute)'}, {'cui': 'C0002111', 'cui_str': 'Allergy Specialty'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C1270908', 'cui_str': 'Food specific immunoglobulin E'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1325847', 'cui_str': 'Sensitization'}, {'cui': 'C0349374', 'cui_str': ""Cow's milk (substance)""}, {'cui': 'C0202086', 'cui_str': 'Immunoglobulin E measurement (procedure)'}, {'cui': 'C0002092', 'cui_str': 'Allergens'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0439526', 'cui_str': 'per milliliter'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]",330.0,0.195053,"The prevalence of food allergy at the second birthday was significantly lower in the BF/EF than in the BF plus CMF groups for immediate (4 [2.6%] vs 20 [13.2%]; RR, 0.20; 95% CI, 0.07-0.57) and anaphylactic (1 [0.7%] vs 13 [8.6%]; RR, 0.08; 95% CI, 0.01-0.58) types.
Conclusions and Relevance


","[{'ForeName': 'Mitsuyoshi', 'Initials': 'M', 'LastName': 'Urashima', 'Affiliation': 'Division of Molecular Epidemiology, Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hidetoshi', 'Initials': 'H', 'LastName': 'Mezawa', 'Affiliation': 'Division of Molecular Epidemiology, Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Mai', 'Initials': 'M', 'LastName': 'Okuyama', 'Affiliation': 'Division of Molecular Epidemiology, Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Urashima', 'Affiliation': 'Department of Pediatrics, Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Daishi', 'Initials': 'D', 'LastName': 'Hirano', 'Affiliation': 'Department of Pediatrics, Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Gocho', 'Affiliation': 'Department of Pediatrics, Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Tachimoto', 'Affiliation': 'Department of Pediatrics, Jikei University School of Medicine, Tokyo, Japan.'}]",JAMA pediatrics,['10.1001/jamapediatrics.2019.3544']
397,31634897,"Augmenting extinction learning with D-cycloserine reduces return of fear: a randomized, placebo-controlled fMRI study.","D-cycloserine (DCS), a partial NMDA-receptor agonist, seems to be a promising enhancer for exposure therapy in anxiety disorders. It has been tested successfully in animal models of fear extinction, where DCS enhanced extinction learning. Applied in clinical studies, results of DCS-augmented exposure therapy remain ambiguous, calling for a deeper understanding of the underlying mechanisms of DCS and its exact effect on extinction learning and return of fear (ROF) in humans. In the present study, we investigated the effect of DCS-augmented extinction learning on behavioral, psychophysiological, and neural indices of ROF during a 24-h delayed recall test. Thirty-seven participants entered a randomized, placebo-controlled, double-blind, 3-day fear conditioning and delayed extinction fMRI design. One hour before extinction training, participants received an oral dose of 50 mg of DCS or a placebo. Behavioral arousal ratings revealed a generalized ROF during extinction recall in the placebo but not DCS group. Furthermore, participants receiving DCS compared to placebo showed attenuated differential BOLD responses in left posterior hippocampus and amygdala from extinction learning to extinction recall, due to increased hippocampal recruitment in placebo and trendwise decreased amygdala responding in DCS subjects. Our finding that DCS reduces ROF in arousal ratings and neural structures subserving defensive reactions support a role for NMDA receptors in extinction memory consolidation and encourage further translational research.",2020,"Furthermore, participants receiving DCS compared to placebo showed attenuated differential BOLD responses in left posterior hippocampus and amygdala from extinction learning to extinction recall, due to increased hippocampal recruitment in placebo and trendwise decreased amygdala responding in DCS subjects.",['Thirty-seven participants'],"['placebo-controlled, double-blind, 3-day fear conditioning and delayed extinction fMRI design', 'DCS-augmented extinction learning', 'DCS', 'placebo', 'D-cycloserine (DCS']","['hippocampal recruitment', 'return of fear', 'behavioral, psychophysiological, and neural indices of ROF', 'extinction learning and return of fear (ROF', 'Behavioral arousal ratings', 'differential BOLD responses']","[{'cui': 'C4319569', 'cui_str': '37 (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0015347', 'cui_str': 'Extinction (Psychology)'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0010590', 'cui_str': 'Cycloserine'}]","[{'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0015347', 'cui_str': 'Extinction (Psychology)'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0443199', 'cui_str': 'Differential (qualifier value)'}]",37.0,0.340641,"Furthermore, participants receiving DCS compared to placebo showed attenuated differential BOLD responses in left posterior hippocampus and amygdala from extinction learning to extinction recall, due to increased hippocampal recruitment in placebo and trendwise decreased amygdala responding in DCS subjects.","[{'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Ebrahimi', 'Affiliation': 'Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Charitéplatz 1, 10117, Berlin, Germany. claudia.ebrahimi@charite.de.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Gechter', 'Affiliation': 'Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Charitéplatz 1, 10117, Berlin, Germany.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Lueken', 'Affiliation': 'Department of Psychology, Humboldt-Universität zu Berlin, Berlin, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Schlagenhauf', 'Affiliation': 'Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Charitéplatz 1, 10117, Berlin, Germany.'}, {'ForeName': 'Hans-Ulrich', 'Initials': 'HU', 'LastName': 'Wittchen', 'Affiliation': 'Institute of Clinical Psychology and Psychotherapy, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Alfons O', 'Initials': 'AO', 'LastName': 'Hamm', 'Affiliation': 'Department of Biological and Clinical Psychology/Psychotherapy, University of Greifswald, Greifswald, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Ströhle', 'Affiliation': 'Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Charitéplatz 1, 10117, Berlin, Germany.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0552-z']
398,31655485,Angiotensin involvement in trauma processing-exploring candidate neurocognitive mechanisms of preventing post-traumatic stress symptoms.,"The angiotensin-II antagonist losartan is a promising candidate that has enhanced extinction in a post-traumatic stress disorder (PTSD) animal model and was related to reducing PTSD symptom development in humans. Here, we investigate the neurocognitive mechanisms underlying these results, testing the effect of losartan on data-driven and contextual processing of traumatic material, mechanisms proposed to be relevant for PTSD development. In a double-blind between-subject design, 40 healthy participants were randomised to a single oral dose of losartan (50 mg) or placebo, 1 h before being exposed to distressing films as a trauma analogue while heart rate (HR) was measured. Peritraumatic processing was investigated using blurry picture stimuli from the films, which transformed into clear images. Data-driven processing was measured by the level of blurriness at which contents were recognised. Contextual processing was measured as the amount of context information retrieved when describing the pictures' contents. Negative-matched control images were used to test perceptual processing of peripheral trauma-cues. Post-traumatic stress symptoms were assessed via self-report questionnaires after analogue trauma and an intrusion diary completed over 4 days following the experiment. Compared to placebo, losartan facilitated contextual processing and enhanced detail perception in the negative-match pictures. During the films, the losartan group recorded lower HR and higher HR variability, reflecting lower autonomic stress responses. We discuss potential mechanisms of losartan in preventing PTSD symptomatology, including the role of reduced arousal and increased contextual processing during trauma exposure, as well as increased threat-safety differentiation when encountering peripheral trauma-cues in the aftermaths of traumatic events.",2020,"Compared to placebo, losartan facilitated contextual processing and enhanced detail perception in the negative-match pictures.",['40 healthy participants'],"['placebo', 'losartan', 'placebo, losartan', 'angiotensin-II antagonist losartan']","['contextual processing and enhanced detail perception', 'Contextual processing', 'lower HR and higher HR variability, reflecting lower autonomic stress responses']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0126174', 'cui_str': 'Losartan'}, {'cui': 'C0373546', 'cui_str': 'Angiotensin II measurement (procedure)'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0558058', 'cui_str': 'Reflecting (finding)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}]",40.0,0.0689031,"Compared to placebo, losartan facilitated contextual processing and enhanced detail perception in the negative-match pictures.","[{'ForeName': 'Lorika', 'Initials': 'L', 'LastName': 'Shkreli', 'Affiliation': 'Department of Psychiatry, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Marcella Lydia', 'Initials': 'ML', 'LastName': 'Woud', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Ruhr-Universität Bochum, Bochum, Germany.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Ramsbottom', 'Affiliation': 'Faculty of Health and Life Sciences, Oxford Brookes University, Oxford, UK.'}, {'ForeName': 'Aleksandra Ewa', 'Initials': 'AE', 'LastName': 'Rupietta', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Ruhr-Universität Bochum, Bochum, Germany.'}, {'ForeName': 'Gerd Thomas', 'Initials': 'GT', 'LastName': 'Waldhauser', 'Affiliation': 'Department of Neuropsychology, Ruhr-Universität Bochum, Bochum, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Kumsta', 'Affiliation': 'Genetic Psychology, Ruhr-Universität Bochum, Bochum, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Reinecke', 'Affiliation': 'Department of Psychiatry, Warneford Hospital, University of Oxford, Oxford, OX37JX, UK. andrea.reinecke@psych.ox.ac.uk.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0553-y']
399,32248846,Physiological responses to maximal eating in men.,"This study investigated metabolic, endocrine, appetite and mood responses to a maximal eating occasion in fourteen men (mean: age 28 (sd 5) years, body mass 77·2 (sd 6·6) kg and BMI 24·2 (sd 2·2) kg/m2) who completed two trials in a randomised crossover design. On each occasion, participants ate a homogenous mixed-macronutrient meal (pizza). On one occasion, they ate until 'comfortably full' (ad libitum) and on the other, until they 'could not eat another bite' (maximal). Mean energy intake was double in the maximal (13 024 (95 % CI 10 964, 15 084) kJ; 3113 (95 % CI 2620, 3605) kcal) compared with the ad libitum trial (6627 (95 % CI 5708, 7547) kJ; 1584 (95 % CI 1364, 1804) kcal). Serum insulin incremental AUC (iAUC) increased approximately 1·5-fold in the maximal compared with ad libitum trial (mean: ad libitum 43·8 (95 % CI 28·3, 59·3) nmol/l × 240 min and maximal 67·7 (95 % CI 47·0, 88·5) nmol/l × 240 min, P < 0·01), but glucose iAUC did not differ between trials (ad libitum 94·3 (95 % CI 30·3, 158·2) mmol/l × 240 min and maximal 126·5 (95 % CI 76·9, 176·0) mmol/l × 240 min, P = 0·19). TAG iAUC was approximately 1·5-fold greater in the maximal v. ad libitum trial (ad libitum 98·6 (95 % CI 69·9, 127·2) mmol/l × 240 min and maximal 146·4 (95 % CI 88·6, 204·1) mmol/l × 240 min, P < 0·01). Total glucagon-like peptide-1, glucose-dependent insulinotropic peptide and peptide tyrosine-tyrosine iAUC were greater in the maximal compared with ad libitum trial (P < 0·05). Total ghrelin concentrations decreased to a similar extent, but AUC was slightly lower in the maximal v. ad libitum trial (P = 0·02). There were marked differences on appetite and mood between trials, most notably maximal eating caused a prolonged increase in lethargy. Healthy men have the capacity to eat twice the energy content required to achieve comfortable fullness at a single meal. Postprandial glycaemia is well regulated following initial overeating, with elevated postprandial insulinaemia probably contributing.",2020,"Total GLP-1, GIP, and PYY iAUC were greater in the maximal compared with ad libitum trial (p < 0.05).","['Healthy men', 'fourteen men (mean ±SD: age 28 ±5 y, body mass 77.2 ±6.6 kg, body mass index 24.2 ±2.2 kg·m-2', 'men']",['homogenous mixed-macronutrient meal (pizza'],"['Postprandial glycaemia', 'comfortable fullness', 'lethargy', 'glucose', 'iAUC', 'Total GLP-1, GIP, and PYY iAUC', 'appetite and mood', 'TAG iAUC', 'Serum insulin iAUC', 'Total ghrelin concentrations']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0453577', 'cui_str': 'Pizza'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0439650', 'cui_str': 'Fullness'}, {'cui': 'C0023380', 'cui_str': 'Lethargy'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0017132', 'cui_str': 'Gastric inhibitory polypeptide'}, {'cui': 'C0070358', 'cui_str': 'Peptide YY'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0037293', 'cui_str': 'Skin tag'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.0966749,"Total GLP-1, GIP, and PYY iAUC were greater in the maximal compared with ad libitum trial (p < 0.05).","[{'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Hengist', 'Affiliation': 'Department for Health, University of Bath, BathBA2 7AY, UK.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Edinburgh', 'Affiliation': 'Department for Health, University of Bath, BathBA2 7AY, UK.'}, {'ForeName': 'Russell G', 'Initials': 'RG', 'LastName': 'Davies', 'Affiliation': 'Department for Health, University of Bath, BathBA2 7AY, UK.'}, {'ForeName': 'Jean-Philippe', 'Initials': 'JP', 'LastName': 'Walhin', 'Affiliation': 'Department for Health, University of Bath, BathBA2 7AY, UK.'}, {'ForeName': 'Jariya', 'Initials': 'J', 'LastName': 'Buniam', 'Affiliation': 'Department for Health, University of Bath, BathBA2 7AY, UK.'}, {'ForeName': 'Lewis J', 'Initials': 'LJ', 'LastName': 'James', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, LoughboroughLE11 3TU, UK.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Rogers', 'Affiliation': 'School of Psychological Science, University of Bristol, BristolBS8 1TU, UK.'}, {'ForeName': 'Javier T', 'Initials': 'JT', 'LastName': 'Gonzalez', 'Affiliation': 'Department for Health, University of Bath, BathBA2 7AY, UK.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Betts', 'Affiliation': 'Department for Health, University of Bath, BathBA2 7AY, UK.'}]",The British journal of nutrition,['10.1017/S0007114520001270']
400,31941707,Feasibility and Acceptability of a Web-Based Dietary Intervention with Text Messages for Colorectal Cancer: A Randomized Pilot Trial.,"BACKGROUND


Diet is associated with colorectal cancer survival. Yet, adherence to nutrition guidelines is low among colorectal cancer survivors.
METHODS


We conducted a pilot trial among colorectal cancer survivors to evaluate a 12-week remote dietary intervention. Participants received print materials and were randomized (1:1) to intervention (website, text messages) or wait-list control. Primary outcomes included feasibility and acceptability. We also explored change in diet from 0 to 12 and 24 weeks and change from 0 to 12 weeks in anthropometry and circulating biomarkers (Trial Registration: NCT02965521).
RESULTS


We randomized 50 colorectal cancer survivors (25 intervention, 25 control). Retention was 90% at 12 weeks and 84% at 24 weeks. Participants had a median age of 55 years and were 66% female, 70% non-Hispanic white, and 96% had a college degree. The intervention arm responded to a median 15 (71%) of 21 text messages that asked for a reply [interquartile range (IQR) = 8, 19] and visited the website a median of 13 (15%) days (IQR = 1, 33) of the 84 study days.
CONCLUSIONS


We developed a Web-based dietary intervention for colorectal cancer survivors. Our pilot results suggest that colorectal cancer survivors may engage more with text messages than a study website. Research to improve tailoring of text messages, while maintaining scalability, is needed.
IMPACT


Remote dietary interventions using text messages may be feasible for colorectal cancer survivors. See all articles in this  CEBP Focus  section, ""Modernizing Population Science.""",2020,Retention was 90% at 12 weeks and 84% at 24 weeks.,"['Participants had a median age of 55 years and were 66% female, 70% non-Hispanic white, and 96% had a college degree', 'colorectal cancer']","['intervention (website, text messages) or wait-list control', 'web-based dietary intervention with text messages']","['Retention', 'Feasibility and acceptability', 'feasibility and acceptability', 'colorectal cancer (CRC) survival']","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}]","[{'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",50.0,0.168248,Retention was 90% at 12 weeks and 84% at 24 weeks.,"[{'ForeName': 'Erin L', 'Initials': 'EL', 'LastName': 'Van Blarigan', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, California. erin.vanblarigan@ucsf.edu.'}, {'ForeName': 'Stacey A', 'Initials': 'SA', 'LastName': 'Kenfield', 'Affiliation': 'Department of Urology, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'June M', 'Initials': 'JM', 'LastName': 'Chan', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Van Loon', 'Affiliation': 'UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Paciorek', 'Affiliation': 'UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Hilary', 'Initials': 'H', 'LastName': 'Chan', 'Affiliation': 'School of Medicine, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Marissa B', 'Initials': 'MB', 'LastName': 'Savoie', 'Affiliation': 'School of Medicine, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Andrea Grace', 'Initials': 'AG', 'LastName': 'Bocobo', 'Affiliation': 'UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California.'}, {'ForeName': 'Vivian N', 'Initials': 'VN', 'LastName': 'Liu', 'Affiliation': 'University of California, Berkeley, Berkeley, California.'}, {'ForeName': 'Louis X', 'Initials': 'LX', 'LastName': 'Wong', 'Affiliation': 'UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Laffan', 'Affiliation': 'UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California.'}, {'ForeName': 'Chloe E', 'Initials': 'CE', 'LastName': 'Atreya', 'Affiliation': 'UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Miaskowski', 'Affiliation': 'Department of Physiologic Nursing, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Yoshimi', 'Initials': 'Y', 'LastName': 'Fukuoka', 'Affiliation': 'Department of Physiologic Nursing, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Meyerhardt', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Alan P', 'Initials': 'AP', 'LastName': 'Venook', 'Affiliation': 'UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California.'}]","Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology",['10.1158/1055-9965.EPI-19-0840']
401,32242215,Effects of Psychosocial Interventions and Caregiving Stress on Cardiovascular Biomarkers in Family Dementia Caregivers: The UCSD Pleasant Events Program (PEP) Randomized Controlled Trial.,"BACKGROUND


This study examined whether biological mechanisms linking dementia caregiving with an increased risk of coronary heart disease can be modified by psychosocial interventions and which caregivers might benefit the most from an intervention.
METHODS


Spousal dementia caregivers were randomized to 12-week treatment with either a behavioral activation intervention (ie, Pleasant Events Program [PEP]; n = 60), or an active control Information and Support (IS; n = 63) condition. Indicators of caregiving stress were assessed pretreatment and circulating cardiovascular biomarkers were measured pre- and posttreatment.
RESULTS


There were no significant changes in biomarker levels from pre- to posttreatment both by treatment condition and across all caregivers. Regardless of the treatment condition, exploratory regression analysis revealed that caregivers were more likely to show significant decreases in C-reactive protein (CRP) and D-dimer when their spouse had severe functional impairment; in interleukin (IL)-6 and CRP when they had greater distress due to care recipient's problem behaviors; in tumor necrosis factor (TNF)-α when they had higher levels of negative affect; and in IL-6, CRP, TNF-α, and D-dimer when they had higher personal mastery. Within the PEP group, caregivers with higher negative affect and those with higher positive affect were more likely to show a reduction in von Willebrand factor and D-dimer, respectively. Within the IS group, caregivers whose spouse had severe functional impairment were more likely to show a decrease in IL-6.
CONCLUSIONS


Unlike the average caregiver, caregivers high in burden/distress and resources might benefit from psychosocial interventions to improve cardiovascular risk, although these observations need confirmation.",2020,There were no significant changes in biomarker levels from pre- to post-treatment both by treatment condition and across all caregivers.,"['Spousal dementia caregivers', 'family dementia caregivers']","['behavioral activation intervention (i.e., Pleasant Events Program PEP; n=60), or an active control Information and Support (IS; n=63) condition', 'psychosocial interventions and caregiving stress']","['biomarker levels', 'cardiovascular biomarkers', 'severe functional impairment', 'C-reactive protein (CRP) and D-dimer', 'IL-6, CRP, TNF-α and D-dimer', 'circulating cardiovascular biomarkers']","[{'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0015576', 'cui_str': 'Family'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0031642', 'cui_str': 'Phosphoenolpyruvate'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0060323', 'cui_str': 'D-dimer'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}]",,0.0579614,There were no significant changes in biomarker levels from pre- to post-treatment both by treatment condition and across all caregivers.,"[{'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'von Känel', 'Affiliation': 'Department of Consultation-Liaison Psychiatry and Psychosomatic Medicine, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Mills', 'Affiliation': 'Department of Psychiatry, University of California San Diego, La Jolla.'}, {'ForeName': 'Joel E', 'Initials': 'JE', 'LastName': 'Dimsdale', 'Affiliation': 'Department of Psychiatry, University of California San Diego, La Jolla.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Ziegler', 'Affiliation': 'Department of Medicine, University of California San Diego, La Jolla.'}, {'ForeName': 'Matthew A', 'Initials': 'MA', 'LastName': 'Allison', 'Affiliation': 'Department of Family Medicine and Public Health, University of California San Diego, La Jolla.'}, {'ForeName': 'Thomas L', 'Initials': 'TL', 'LastName': 'Patterson', 'Affiliation': 'Department of Psychiatry, University of California San Diego, La Jolla.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Ancoli-Israel', 'Affiliation': 'Department of Psychiatry, University of California San Diego, La Jolla.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Pruitt', 'Affiliation': 'Department of Family Medicine and Public Health, University of California San Diego, La Jolla.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Grant', 'Affiliation': 'Department of Psychiatry, University of California San Diego, La Jolla.'}, {'ForeName': 'Brent T', 'Initials': 'BT', 'LastName': 'Mausbach', 'Affiliation': 'Department of Psychiatry, University of California San Diego, La Jolla.'}]","The journals of gerontology. Series A, Biological sciences and medical sciences",['10.1093/gerona/glaa079']
402,31383995,"Sertraline treatment decreased the serum levels of interleukin-6 and high-sensitivity C-reactive protein in hematopoietic stem cell transplantation patients with depression; a randomized double-blind, placebo-controlled clinical trial.",,2020,,['hematopoietic stem cell transplantation patients with depression'],"['placebo', 'Sertraline']",['serum levels of interleukin-6 and high-sensitivity C-reactive protein'],"[{'cui': 'C0472699', 'cui_str': 'Hematopoietic Stem Cell Transplantation'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}]",,0.506102,,"[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Tavakoli Ardakani', 'Affiliation': 'Department of Clinical Pharmacy, Shahid Beheshti University of Medical Sciences, School of Pharmacy, Tehran, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Mehrpooya', 'Affiliation': 'Department of Clinical Pharmacy, Hamadan University of Medical Sciences, School of Pharmacy, Hamadan, Iran.'}, {'ForeName': 'Mahshid', 'Initials': 'M', 'LastName': 'Mehdizadeh', 'Affiliation': 'Taleghani Bone Marrow Transplantation Center, Taleghani Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran. mahshid_mehdizadeh@yahoo.com.'}, {'ForeName': 'Narges', 'Initials': 'N', 'LastName': 'Beiraghi', 'Affiliation': 'Department of Psychiatry, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Hajifathali', 'Affiliation': 'Taleghani Bone Marrow Transplantation Center, Taleghani Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad Hossein', 'Initials': 'MH', 'LastName': 'Kazemi', 'Affiliation': 'Hematopoietic Stem Cell Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Bone marrow transplantation,['10.1038/s41409-019-0623-0']
403,30476587,Variation in Endoscopic Activity Assessment and Endoscopy Score Validation in Adults With Eosinophilic Esophagitis.,"BACKGROUND & AIMS


Eosinophilic esophagitis (EoE) is assessed endoscopically (endoscopic activity), based on grades of edema, rings, exudates, furrows, and strictures (EREFS). We examined variations in endoscopic assessments of severity, developed and validated 3 EREFS-based scoring systems, and assessed responsiveness of these systems using data from a randomized placebo-controlled trial of patients with EoE.
METHODS


For the development set, 5 gastroenterologists reviewed EREFS findings from 266 adults with EoE and provided endoscopist global assessment scores (EndoGA, scale of 0 to 10); variation (ΔEndoGA) was assessed using linear regression. We evaluated simple scores (features given arbitrary values from 0 to 3) and developed 2 scoring systems (adjusted score range, 0-100). We then fitted our linear regression model with mean EndoGA to data from 146 adults recruited in centers in Switzerland and the United States between April 2011 and December 2012. For the validation set, we collected data from 120 separate adults (recruited in centers in Switzerland and the United States between May 2013 and July 2014), assessing regression coefficient-based scores using Bland-Altman method. We assessed the responsiveness of our scoring systems using data from a randomized trial of patients with EoE given fluticasone (n=16) or placebo (n=8).
RESULTS


The distribution of EndoGA values differed among endoscopists (mean ΔEndoGA, 2.6±1.8; range 0-6.6). We developed 2 regression-based scoring systems to assess overall and proximal and distal esophageal findings; variation in endoscopic features accounted for more than 90% of the mean EndoGA variation. In the validation group, differences between mean EndoGA and regression-based scores were small (ranging from -4.70 to 2.03), indicating good agreement. In analyses of data from the randomized trial, the baseline to end of study change in patients given fluticasone was a reduction of 24.3 in simple score (reduction of 4.6 in patients given placebo, P=.052); a reduction of 23.5 in regression-based overall score (reduction of 6.56 in patients given placebo, P=.12), and a reduction of 23.8 (reduction of 8.44 in patients given placebo, P=.11).
CONCLUSION


Assessments of endoscopic activity in patients with EoE vary among endoscopists. In an analysis of data from a randomized controlled trial, we found that newly developed scoring systems are no better than simple scoring system in detecting changes in endoscopic activity. These results support the use of a simple scoring system in evaluation of endoscopic activity in patients with EoE. clinicaltrials.gov no: NCT00939263 and NCT01386112.",2019,"The distribution of EndoGA values differed among endoscopists (mean ΔEndoGA, 2.6±1.8; range 0-6.6).","['Adults With Eosinophilic Esophagitis', 'patients with EoE.\nMETHODS\n\n\nFor the development set, 5 gastroenterologists reviewed EREFS findings from 266 adults with EoE and provided', '146 adults recruited in centers in Switzerland and the United States between April 2011 and December 2012', 'n=16) or', 'patients with EoE given', 'n=8', 'patients with EoE vary among endoscopists', '120 separate adults (recruited in centers in Switzerland and the United States between May 2013 and July 2014']","['fluticasone', 'placebo']","['endoscopist global assessment scores (EndoGA, scale of 0 to 10); variation (ΔEndoGA', 'distribution of EndoGA values', 'Endoscopic Activity Assessment and Endoscopy Score Validation', 'mean EndoGA and regression-based scores']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0341106', 'cui_str': 'Chronic Esophagitis, Eosinophilic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0259901', 'cui_str': 'Gastroenterologist'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C2607943', 'cui_str': 'findings'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}]","[{'cui': 'C0082607', 'cui_str': 'fluticasone'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0684321', 'cui_str': 'Regression'}, {'cui': 'C0178499', 'cui_str': 'Base'}]",146.0,0.172121,"The distribution of EndoGA values differed among endoscopists (mean ΔEndoGA, 2.6±1.8; range 0-6.6).","[{'ForeName': 'Alain M', 'Initials': 'AM', 'LastName': 'Schoepfer', 'Affiliation': 'Division of Gastroenterology and Hepatology, Centre Hospitalier Universitaire Vaudois/CHUV, Lausanne, Switzerland. Electronic address: alain.schoepfer@chuv.ch.'}, {'ForeName': 'Ikuo', 'Initials': 'I', 'LastName': 'Hirano', 'Affiliation': 'Division of Gastroenterology, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Coslovsky', 'Affiliation': 'Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Marie C', 'Initials': 'MC', 'LastName': 'Roumet', 'Affiliation': 'Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Zwahlen', 'Affiliation': 'Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Claudia E', 'Initials': 'CE', 'LastName': 'Kuehni', 'Affiliation': 'Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hafner', 'Affiliation': 'Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Alexander', 'Affiliation': 'Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Evan S', 'Initials': 'ES', 'LastName': 'Dellon', 'Affiliation': 'Center for Esophageal Diseases and Swallowing, Division of Gastroenterology and Hepatology, University of North Carolina School of Medicine, Chapel Hill, North Carolina.'}, {'ForeName': 'Nirmala', 'Initials': 'N', 'LastName': 'Gonsalves', 'Affiliation': 'Division of Gastroenterology, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Leung', 'Affiliation': 'Center for Food Related Diseases, Division of Pediatric Allergy and Immunology, Division of Gastroenterology, Tufts Medical Center and Floating Hospital for Children, Boston, Massachusetts.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Bussmann', 'Affiliation': 'Viollier AG, Institute for Pathology, Basel, Switzerland.'}, {'ForeName': 'Margaret H', 'Initials': 'MH', 'LastName': 'Collins', 'Affiliation': ""Division of Pathology and Laboratory Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'Robert O', 'Initials': 'RO', 'LastName': 'Newbury', 'Affiliation': ""Department of Pathology, Rady Children's Hospital, University of California, San Diego, San Diego, California.""}, {'ForeName': 'Thomas C', 'Initials': 'TC', 'LastName': 'Smyrk', 'Affiliation': 'Department of Laboratory Medicine and Pathology, Mayo Clinic College of Medicine, Rochester, Minnesota.'}, {'ForeName': 'John T', 'Initials': 'JT', 'LastName': 'Woosley', 'Affiliation': 'Department of Pathology and Laboratory Medicine, University of North Carolina School of Medicine, Chapel Hill, North Carolina.'}, {'ForeName': 'Guang-Yu', 'Initials': 'GY', 'LastName': 'Yang', 'Affiliation': 'Department of Pathology, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Romero', 'Affiliation': 'Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota; Department of Otolaryngology, Mayo Clinic, Rochester, Minnesota; GI Outcomes Unit, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Katzka', 'Affiliation': 'Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Glenn T', 'Initials': 'GT', 'LastName': 'Furuta', 'Affiliation': ""Gastrointestinal Eosinophilic Diseases Program, Department of Pediatrics, University of Colorado School of Medicine; Digestive Health Institute, Children's Hospital Colorado, Aurora, Colorado.""}, {'ForeName': 'Sandeep K', 'Initials': 'SK', 'LastName': 'Gupta', 'Affiliation': 'Division of Pediatric Gastroenterology, Hepatology, and Nutrition, Riley Hospital for Children, Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Seema S', 'Initials': 'SS', 'LastName': 'Aceves', 'Affiliation': ""Division of Allergy and Immunology, Rady Children's Hospital, University of California, San Diego, San Diego, California.""}, {'ForeName': 'Mirna', 'Initials': 'M', 'LastName': 'Chehade', 'Affiliation': 'Departments of Pediatrics and Medicine, Mount Sinai Center for Eosinophilic Disorders, Jaffe Food Allergy Institute, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Spergel', 'Affiliation': ""Divisions of Allergy and Immunology, Department of Pediatrics, The Children's Hospital of Philadelphia, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.""}, {'ForeName': 'Gary W', 'Initials': 'GW', 'LastName': 'Falk', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Brian A', 'Initials': 'BA', 'LastName': 'Meltzer', 'Affiliation': 'Adare Pharmaceuticals, Inc, Lawrenceville, New Jersey.'}, {'ForeName': 'Gail M', 'Initials': 'GM', 'LastName': 'Comer', 'Affiliation': 'Kimberton Drug Development Consulting, LLC, Phoenixville, Pennsylvania.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Straumann', 'Affiliation': 'Swiss EoE Clinic, Division of Gastroenterology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Ekaterina', 'Initials': 'E', 'LastName': 'Safroneeva', 'Affiliation': 'Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2018.11.032']
404,31248973,First-line therapy with either bortezomib-melphalan-prednisone or lenalidomide-dexamethasone followed by lenalidomide for transplant-ineligible multiple myeloma patients: a pooled analysis of two randomized trials.,"Bortezomib-melphalan-prednisone (VMP) and continuous lenalidomide-dexamethasone (Rd) represent the standard treatment of transplant-ineligible patients with newly diagnosed multiple myeloma (MM). To date, no randomized trial has compared VMP to Rd, and there is no evidence of the optimal treatment for newly diagnosed MM, particularly in patients with high-risk cytogenetics [del(17p), t(4;14) or t(14;16)]. We pooled together data from patients with newly diagnosed MM treated with VMP or Rd induction followed by lenalidomide maintenance 10 mg (Rd-R) enrolled in the GIMEMA-MM-03-05 and EMN01 trials, to evaluate the efficacy of these treatments in different subgroups of patients, focusing on those with standard- and high-risk cytogenetics. Overall, 474 patients were analyzed (VMP: 257 patients; Rd-R: 217 patients). No differences in progression-free survival (hazard ratio=0.96) and overall survival (hazard ratio=1.08) were observed between standard-risk patients treated with VMP or Rd-R, whereas among the high-risk patients, the probabilities of progression (hazard ratio=0.54) and death (hazard ratio=0.73) were lower in the patients treated with VMP than in those treated with Rd-R. In particular, standard-risk patients >75 years benefited less from VMP than from Rd-R (hazard ratio for progression-free survival=0.96; hazard ratio for overall survival=1.81). In this non-randomized analysis, VMP and Rd-R were equally effective in younger (≤75 years), standard-risk patients, while older ones (>75 years) benefited more from Rd-R. In high-risk patients, VMP improved progression-free survival and overall survival irrespective of age. The source trials are registered at ClinicalTrials.gov (NCT01063179 and NCT01093196).",2020,"No difference in progression-free survival (Hazard Ratio: 0.96) and overall survival (Hazard Ratio: 1.08) was observed between bortezomib-melphalan-prednisone and lenalidomide-dexamethasone followed by lenalidomide in standard-risk, while a reduction in the risk of progression (Hazard Ratio: 0.54) and death (Hazard Ratio: 0.73) was seen in high-risk patients treated with bortezomib-melphalan-prednisone vs. lenalidomide-dexamethasone followed by lenalidomide.","['257 patients', 'transplant-ineligible, newly diagnosed, multiple myeloma patients', 'transplant-ineligible multiple myeloma patients', 'younger (≤75years), standard-risk patients, while older ones (>75years) benefited more from', '474 patients were', 'newly diagnosed myeloma patients treated with']","['lenalidomide-dexamethasone', 'bortezomib-melphalan-prednisone to lenalidomide-dexamethasone', 'bortezomib-melphalan-prednisone and lenalidomide-dexamethasone', 'Bortezomib-melphalan-prednisone and continuous lenalidomide-dexamethasone', 'bortezomib-melphalan-prednisone vs. lenalidomide-dexamethasone', 'bortezomib-melphalan-prednisone', 'bortezomib-melphalan-prednisone or lenalidomide-dexamethasone induction followed by lenalidomide maintenance', 'bortezomib-melphalan-prednisone or lenalidomide-dexamethasone', 'analyzed (bortezomib-melphalan-prednisone']","['death', 'overall survival', 'progression-free survival', 'progression-free survival and overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C0026764', 'cui_str': 'Myelomatosis'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205447', 'cui_str': '1'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C1176309', 'cui_str': 'bortezomib'}, {'cui': 'C0025241', 'cui_str': 'Melphalan'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",474.0,0.107143,"No difference in progression-free survival (Hazard Ratio: 0.96) and overall survival (Hazard Ratio: 1.08) was observed between bortezomib-melphalan-prednisone and lenalidomide-dexamethasone followed by lenalidomide in standard-risk, while a reduction in the risk of progression (Hazard Ratio: 0.54) and death (Hazard Ratio: 0.73) was seen in high-risk patients treated with bortezomib-melphalan-prednisone vs. lenalidomide-dexamethasone followed by lenalidomide.","[{'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Larocca', 'Affiliation': 'Myeloma Unit, Division of Hematology, University of Torino, Azienda-Ospedaliero Universitaria (AOU) Città della Salute e della Scienza di Torino, Torino, Italy alelarocca@hotmail.com.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Mina', 'Affiliation': 'Myeloma Unit, Division of Hematology, University of Torino, Azienda-Ospedaliero Universitaria (AOU) Città della Salute e della Scienza di Torino, Torino, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Offidani', 'Affiliation': 'Clinica di Ematologia, AOU Ospedali Riuniti di Ancona, Ancona, Italy.'}, {'ForeName': 'Anna Marina', 'Initials': 'AM', 'LastName': 'Liberati', 'Affiliation': 'Università degli Studi di Perugia, Azienda Ospedaliera (AO) Santa Maria, Terni, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Ledda', 'Affiliation': 'Ematologia/CTMO Ospedale ""A. Businco"", Cagliari, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Patriarca', 'Affiliation': 'Udine University Hospital, DAME, University of Udine, Udine, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Evangelista', 'Affiliation': 'Unit of Clinical Epidemiology, AOU Città della Salute e della Scienza di Torino e CPO, Piemonte, Torino, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Spada', 'Affiliation': 'Myeloma Unit, Division of Hematology, University of Torino, Azienda-Ospedaliero Universitaria (AOU) Città della Salute e della Scienza di Torino, Torino, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Benevolo', 'Affiliation': 'Hematology, Città della Salute e della Scienza, Torino, Italy.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Oddolo', 'Affiliation': 'Myeloma Unit, Division of Hematology, University of Torino, Azienda-Ospedaliero Universitaria (AOU) Città della Salute e della Scienza di Torino, Torino, Italy.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Innao', 'Affiliation': 'U.O.C. Ematologia AOU G. Martino, Messina, Italy.'}, {'ForeName': 'Clotilde', 'Initials': 'C', 'LastName': 'Cangiolosi', 'Affiliation': 'AO Villa Sofia-Cervello, Divisione Ematologia I UTMO, Palermo, Italy.'}, {'ForeName': 'Annalisa', 'Initials': 'A', 'LastName': 'Bernardini', 'Affiliation': 'Myeloma Unit, Division of Hematology, University of Torino, Azienda-Ospedaliero Universitaria (AOU) Città della Salute e della Scienza di Torino, Torino, Italy.'}, {'ForeName': 'Pellegrino', 'Initials': 'P', 'LastName': 'Musto', 'Affiliation': 'Unit of Haematology and Stem Cell Transplantation, IRCCS-CROB, Referral Cancer Center of Basilicata, Rionero in Vulture, Italy.'}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Amico', 'Affiliation': 'DH-Ematologico AO ""S.Pio"", Benevento, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Fraticelli', 'Affiliation': 'Fondazione ""Giovanni Paolo II"", Unità Operativa Complessa di Oncoematologia, Campobasso, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Paris', 'Affiliation': 'Hematology and Bone Marrow Transplant Unit, Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Giuliani', 'Affiliation': 'Department of Medicine and Surgery, University of Parma, Parma, Italy.'}, {'ForeName': 'Antonietta Pia', 'Initials': 'AP', 'LastName': 'Falcone', 'Affiliation': 'Ematologia, IRCCS ""Casa Sollievo della Sofferenza"" Hospita, San Giovanni Rotondo, Italy.'}, {'ForeName': 'Renato', 'Initials': 'R', 'LastName': 'Zambello', 'Affiliation': 'Padova University School of Medicine, Hematology and Clinical Immunology, Padova, Italy.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'De Paoli', 'Affiliation': 'Università del Piemonte Orientale A. Avogadro, Novara, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Romano', 'Affiliation': 'Division of Hematology, AOU Policlinico, Department of Surgery and Medical Specialties, University of Catania, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Palumbo', 'Affiliation': 'Myeloma Unit, Division of Hematology, University of Torino, Azienda-Ospedaliero Universitaria (AOU) Città della Salute e della Scienza di Torino, Torino, Italy.'}, {'ForeName': 'Vittorio', 'Initials': 'V', 'LastName': 'Montefusco', 'Affiliation': 'Hematology, Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Hájek', 'Affiliation': 'Department of Hematooncology University Hospital Ostrava, Ostrava, Czech Republic.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Boccadoro', 'Affiliation': 'Myeloma Unit, Division of Hematology, University of Torino, Azienda-Ospedaliero Universitaria (AOU) Città della Salute e della Scienza di Torino, Torino, Italy.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Bringhen', 'Affiliation': 'Myeloma Unit, Division of Hematology, University of Torino, Azienda-Ospedaliero Universitaria (AOU) Città della Salute e della Scienza di Torino, Torino, Italy.'}]",Haematologica,['10.3324/haematol.2019.220657']
405,31454829,Acute kidney injury risk-based screening in pediatric inpatients: a pragmatic randomized trial.,"BACKGROUND


Pediatric acute kidney injury (AKI) is common and associated with increased morbidity, mortality, and length of stay. We performed a pragmatic randomized trial testing the hypothesis that AKI risk alerts increase AKI screening.
METHODS


All intensive care and ward admissions of children aged 28 days through 21 years without chronic kidney disease from 12/6/2016 to 11/1/2017 were included. The intervention alert displayed if calculated AKI risk was > 50% and no serum creatinine (SCr) was ordered within 24 h. The primary outcome was SCr testing within 48 h of AKI risk > 50%.
RESULTS


Among intensive care admissions, 973/1909 (51%) were randomized to the intervention. Among those at risk, more SCr tests were ordered for the intervention group than for controls (418/606, 69% vs. 361/597, 60%, p = 0.002). AKI incidence and severity were the same in intervention and control groups. Among ward admissions, 5492/10997 (50%) were randomized to the intervention, and there were no differences between groups in SCr testing, AKI incidence, or severity of AKI.
CONCLUSIONS


Alerts based on real-time prediction of AKI risk increased screening rates in intensive care but not pediatric ward settings. Pragmatic clinical trials provide the opportunity to assess clinical decision support and potentially eliminate ineffective alerts.",2020,AKI incidence and severity were the same in intervention and control groups.,"['pediatric inpatients', 'All intensive care and ward admissions of children aged 28 days through 21 years without chronic kidney disease from 12/6/2016 to 11/1/2017 were included']",[],"['serum creatinine (SCr', 'SCr tests', 'AKI incidence and severity', 'morbidity, mortality, and length of stay', 'SCr testing within 48\u2009h of AKI risk', 'SCr testing, AKI incidence, or severity of AKI', 'calculated AKI risk']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0085559'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]",[],"[{'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",,0.192399,AKI incidence and severity were the same in intervention and control groups.,"[{'ForeName': 'Sara L', 'Initials': 'SL', 'LastName': 'Van Driest', 'Affiliation': 'Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, TN, USA. sara.van.driest@vumc.org.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Biostatistics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Michael F', 'Initials': 'MF', 'LastName': 'McLemore', 'Affiliation': 'Health Information Technology, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Brian C', 'Initials': 'BC', 'LastName': 'Bridges', 'Affiliation': 'Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Geoffrey M', 'Initials': 'GM', 'LastName': 'Fleming', 'Affiliation': 'Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Tracy L', 'Initials': 'TL', 'LastName': 'McGregor', 'Affiliation': 'Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Deborah P', 'Initials': 'DP', 'LastName': 'Jones', 'Affiliation': 'Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Shirey-Rice', 'Affiliation': 'Institute for Clinical and Translational Research, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Cheryl L', 'Initials': 'CL', 'LastName': 'Gatto', 'Affiliation': 'Institute for Clinical and Translational Research, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'Gay', 'Affiliation': 'Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Daniel W', 'Initials': 'DW', 'LastName': 'Byrne', 'Affiliation': 'Department of Biostatistics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Asli', 'Initials': 'A', 'LastName': 'Weitkamp', 'Affiliation': 'Department of Biomedical Informatics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Dan M', 'Initials': 'DM', 'LastName': 'Roden', 'Affiliation': 'Department of Medicine, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Bernard', 'Affiliation': 'Department of Medicine, Vanderbilt University School of Medicine, Nashville, TN, USA.'}]",Pediatric research,['10.1038/s41390-019-0550-1']
406,32248243,GAD-alum immunotherapy in type 1 diabetes expands bifunctional Th1/Th2 autoreactive CD4 T cells.,"AIMS/HYPOTHESIS


Antigen-specific therapy aims to modify inflammatory T cell responses in type 1 diabetes and restore immune tolerance. One strategy employs GAD65 conjugated to aluminium hydroxide (GAD-alum) to take advantage of the T helper (Th)2-biasing adjuvant properties of alum and thereby regulate pathological Th1 autoimmunity. We explored the cellular and molecular mechanism of GAD-alum action in the setting of a previously reported randomised placebo-controlled clinical trial conducted by Type 1 Diabetes TrialNet.
METHODS


In the clinical trial conducted by Type 1 Diabetes TrialNet, participants were immunised with 20 μg GAD-alum (twice or three times) or alum alone and peripheral blood mononuclear cell samples were banked at baseline and post treatment. In the present study, GAD-specific T cell responses were measured in these samples and GAD-specific T cell lines and clones were generated, which were then further characterised.
RESULTS


At day 91 post immunisation, we detected GAD-specific IL-13 +  CD4 T cell responses significantly more frequently in participants immunised with GAD-alum (71% and 94% treated twice or three times, respectively) compared with those immunised with alum alone (38%; p = 0.003 and p = 0.0002, respectively) accompanied by high secreted levels of IL-13, IL-4 and IL-5, confirming a GAD-specific, GAD-alum-induced Th2 response. Of note, GAD-specific, IL-13 +  CD4 T cells observed after immunisation co-secreted IFN-γ, displaying a bifunctional Th1/Th2 phenotype. Single-cell transcriptome analysis identified IL13 and IFNG expression in concert with the canonical Th2 and Th1 transcription factor genes GATA3 and TBX21, respectively. T cell receptor β-chain (TCRB) CDR3 regions of GAD-specific bifunctional T cells were identified in circulating naive and central memory CD4 T cell pools of non-immunised participants with new-onset type 1 diabetes and healthy individuals, suggesting the potential for bifunctional responses to be generated de novo by GAD-alum immunisation or via expansion from an existing public repertoire.
CONCLUSIONS/INTERPRETATION


GAD-alum immunisation activates and propagates GAD-specific CD4 T cells with a distinctive bifunctional phenotype, the functional analysis of which might be important in understanding therapeutic responses.",2020,"At day 91 post immunisation, we detected GAD-specific IL-13 +  CD4 T cell responses significantly more frequently in participants immunised with GAD-alum (71% and 94% treated twice or three times, respectively) compared with those immunised with alum alone (38%; p = 0.003 and p = 0.0002, respectively) accompanied by high secreted levels of IL-13, IL-4 and IL-5, confirming a GAD-specific, GAD-alum-induced Th2 response.",[],"['aluminium hydroxide (GAD-alum', 'placebo', 'GAD-alum immunotherapy']","['GAD-specific IL-13 +  CD4 T cell responses', 'IL-13, IL-4 and IL-5, confirming a GAD-specific, GAD-alum-induced Th2 response', 'GAD-specific, IL-13 +  CD4 T cells', 'GAD-specific T cell responses', 'IL13 and IFNG expression', 'T cell receptor β-chain (TCRB']",[],"[{'cui': 'C0002371', 'cui_str': 'Aluminum Hydroxide'}, {'cui': 'C0270549', 'cui_str': 'Generalized anxiety disorder'}, {'cui': 'C0051522', 'cui_str': 'aluminum sulfate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}]","[{'cui': 'C0270549', 'cui_str': 'Generalized anxiety disorder'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0214743', 'cui_str': 'Interleukin 13'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0021758', 'cui_str': 'Interleukin-4'}, {'cui': 'C0021759', 'cui_str': 'Interleukin-5'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0051522', 'cui_str': 'aluminum sulfate'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0021745', 'cui_str': 'Interferon Type II'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0034790', 'cui_str': 'T-cell antigen receptor'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0087049', 'cui_str': 'T-Cell Receptors beta-Chain'}]",,0.0923879,"At day 91 post immunisation, we detected GAD-specific IL-13 +  CD4 T cell responses significantly more frequently in participants immunised with GAD-alum (71% and 94% treated twice or three times, respectively) compared with those immunised with alum alone (38%; p = 0.003 and p = 0.0002, respectively) accompanied by high secreted levels of IL-13, IL-4 and IL-5, confirming a GAD-specific, GAD-alum-induced Th2 response.","[{'ForeName': 'Sefina', 'Initials': 'S', 'LastName': 'Arif', 'Affiliation': ""Peter Gorer Department of Immunobiology, King's College London Faculty of Life Sciences and Medicine, 2nd Floor, Borough Wing, Guy's Hospital, London, SE1 9RT, UK.""}, {'ForeName': 'Iria', 'Initials': 'I', 'LastName': 'Gomez-Tourino', 'Affiliation': ""Peter Gorer Department of Immunobiology, King's College London Faculty of Life Sciences and Medicine, 2nd Floor, Borough Wing, Guy's Hospital, London, SE1 9RT, UK.""}, {'ForeName': 'Yogesh', 'Initials': 'Y', 'LastName': 'Kamra', 'Affiliation': ""Peter Gorer Department of Immunobiology, King's College London Faculty of Life Sciences and Medicine, 2nd Floor, Borough Wing, Guy's Hospital, London, SE1 9RT, UK.""}, {'ForeName': 'Irma', 'Initials': 'I', 'LastName': 'Pujol-Autonell', 'Affiliation': ""Peter Gorer Department of Immunobiology, King's College London Faculty of Life Sciences and Medicine, 2nd Floor, Borough Wing, Guy's Hospital, London, SE1 9RT, UK.""}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Hanton', 'Affiliation': ""Peter Gorer Department of Immunobiology, King's College London Faculty of Life Sciences and Medicine, 2nd Floor, Borough Wing, Guy's Hospital, London, SE1 9RT, UK.""}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Tree', 'Affiliation': ""Peter Gorer Department of Immunobiology, King's College London Faculty of Life Sciences and Medicine, 2nd Floor, Borough Wing, Guy's Hospital, London, SE1 9RT, UK.""}, {'ForeName': 'Daisy', 'Initials': 'D', 'LastName': 'Melandri', 'Affiliation': ""Peter Gorer Department of Immunobiology, King's College London Faculty of Life Sciences and Medicine, 2nd Floor, Borough Wing, Guy's Hospital, London, SE1 9RT, UK.""}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Hull', 'Affiliation': ""Peter Gorer Department of Immunobiology, King's College London Faculty of Life Sciences and Medicine, 2nd Floor, Borough Wing, Guy's Hospital, London, SE1 9RT, UK.""}, {'ForeName': 'Diane K', 'Initials': 'DK', 'LastName': 'Wherrett', 'Affiliation': 'Division of Endocrinology, Department of Pediatrics, The Hospital for Sick Children, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Beam', 'Affiliation': 'Homer Stryker MD School of Medicine, Western Michigan University, Kalamazoo, MI, USA.'}, {'ForeName': 'Bart O', 'Initials': 'BO', 'LastName': 'Roep', 'Affiliation': 'Diabetes and Metabolism Research Institute, City of Hope, Duarte, CA, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Lorenc', 'Affiliation': ""Peter Gorer Department of Immunobiology, King's College London Faculty of Life Sciences and Medicine, 2nd Floor, Borough Wing, Guy's Hospital, London, SE1 9RT, UK.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Peakman', 'Affiliation': ""Peter Gorer Department of Immunobiology, King's College London Faculty of Life Sciences and Medicine, 2nd Floor, Borough Wing, Guy's Hospital, London, SE1 9RT, UK. mark.peakman@kcl.ac.uk.""}]",Diabetologia,['10.1007/s00125-020-05130-7']
407,31977595,Brief Report: Virologic Response by Baseline Viral Load With Dolutegravir Plus Lamivudine vs Dolutegravir Plus Tenofovir Disoproxil Fumarate/Emtricitabine: Pooled Analysis.,"BACKGROUND


To investigate antiviral potency of the 2-drug regimen (2DR) dolutegravir plus lamivudine vs the 3-drug regimen (3DR) dolutegravir plus tenofovir disoproxil fumarate/emtricitabine, we performed a post-hoc analysis assessing antiviral response rates in the phase III GEMINI-1 and GEMINI-2 studies by baseline viral load (VL).
SETTING


One hundred ninety-two centers in 21 countries.
METHODS


Treatment-naive HIV-1-infected participants with screening VL ≤500,000 copies/mL were randomized 1:1 to once-daily dolutegravir plus lamivudine or dolutegravir plus tenofovir disoproxil fumarate/emtricitabine. Median change from baseline was determined for log10-transformed VL in the overall study population and the subpopulation with baseline VL >100,000 copies/mL. Proportion of participants achieving plasma VL <50 copies/mL (Snapshot algorithm) or <40 copies/mL (Abbott RealTime HIV-1 assay) and target not detected was assessed through week 48 by baseline VL. Time to viral suppression was determined (nonparametric Kaplan-Meier method).
RESULTS


For 293 participants with baseline VL >100,000 copies/mL, median change from baseline at week 4 was -3.38 and -3.40 log10 copies/mL in the 2DR and 3DR groups, respectively; reduction was sustained throughout 48 weeks. Time to VL <50 copies/mL was longer in participants with baseline VL >100,000 copies/mL than the overall study population (57 [week 8] vs 29 days [week 4]) and similar between the 2DR and 3DR groups. Proportion of participants with VL <50 or <40 copies/mL and target not detected was similar between groups, irrespective of baseline VL, at all tested visits throughout 48 weeks.
CONCLUSION


Dolutegravir plus lamivudine demonstrates high antiviral potency in treatment-naive HIV-1-infected individuals across baseline VL strata.",2020,"Time to VL <50 copies/mL was longer in participants with baseline VL >100,000 copies/mL than the overall study population (57 [Week 8] vs 29 days [Week 4]) and similar between the 2DR and 3DR groups.","['Treatment-naive HIV-1-infected participants with screening VL <500,000 copies/mL', '192 centers in 21 countries']","['Dolutegravir plus lamivudine', 'daily dolutegravir plus lamivudine or dolutegravir plus tenofovir disoproxil fumarate/emtricitabine', 'lamivudine', 'Dolutegravir Plus Lamivudine vs Dolutegravir Plus Tenofovir Disoproxil Fumarate/Emtricitabine', 'tenofovir disoproxil fumarate/emtricitabine']","['antiviral potency', 'Time to viral suppression', 'antiviral response rates', 'Virologic Response']","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}]","[{'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0209738', 'cui_str': 'Lamivudine'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}]","[{'cui': 'C1874329', 'cui_str': 'Antivirals, topical'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0205466', 'cui_str': 'virology'}]",293.0,0.414981,"Time to VL <50 copies/mL was longer in participants with baseline VL >100,000 copies/mL than the overall study population (57 [Week 8] vs 29 days [Week 4]) and similar between the 2DR and 3DR groups.","[{'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Eron', 'Affiliation': 'University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, NC.'}, {'ForeName': 'Chien-Ching', 'Initials': 'CC', 'LastName': 'Hung', 'Affiliation': 'National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan.'}, {'ForeName': 'Jean-Guy', 'Initials': 'JG', 'LastName': 'Baril', 'Affiliation': 'Clinique Médicale du Quartier Latin, Montréal, Québec, Canada.'}, {'ForeName': 'Jihad', 'Initials': 'J', 'LastName': 'Slim', 'Affiliation': ""Saint Michael's Medical Center, Newark, NJ.""}, {'ForeName': 'Vicenç', 'Initials': 'V', 'LastName': 'Falcó', 'Affiliation': ""Hospital Vall d'Hebron, Barcelona, Spain.""}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Bogner', 'Affiliation': 'Internal Medicine IV, University Hospital Munich, Munich, Germany.'}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Maggiolo', 'Affiliation': 'ASST Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Mills', 'Affiliation': ""Men's Health Foundation, Los Angeles CA.""}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Sievers', 'Affiliation': 'ViiV Healthcare, Brentford, United Kingdom.'}, {'ForeName': 'Choy Y', 'Initials': 'CY', 'LastName': 'Man', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC.'}, {'ForeName': 'Rimgaile', 'Initials': 'R', 'LastName': 'Urbaityte', 'Affiliation': 'GlaxoSmithKline, London, United Kingdom.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Underwood', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC.'}, {'ForeName': 'Allan R', 'Initials': 'AR', 'LastName': 'Tenorio', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC.'}, {'ForeName': 'Keith A', 'Initials': 'KA', 'LastName': 'Pappa', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Wynne', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Koteff', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Gartland', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC.'}, {'ForeName': 'Kimberly Y', 'Initials': 'KY', 'LastName': 'Smith', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Aboud', 'Affiliation': 'ViiV Healthcare, Brentford, United Kingdom.'}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002302']
408,32214373,Precision nicotine metabolism-informed care for smoking cessation in Crohn's disease: A pilot study.,"INTRODUCTION


Smoking is a strong risk factor for disease severity in Crohn's disease (CD) and cessation improves outcomes. The nicotine metabolite ratio (NMR) predicts cessation success with pharmacotherapy: varenicline doubles cessation over nicotine replacement therapy (NRT) for ""normal"", but not ""slow"" metabolizers. Varenicline side effects are heightened in slow metabolizers. Methods using NMR to optimize cessation pharmacotherapy have not been evaluated in CD.
AIMS


We aim to determine the prevalence of smoking in a CD population and then assess these smokers' attitudes toward a personalized metabolism-informed care (MIC) approach to cessation.
METHODS


In this observational study, we surveyed 1098 patients visiting an inflammatory bowel disease center about their smoking history. We then evaluated a subgroup of individuals with CD (n = 32) who participated in a randomized controlled trial of smoking cessation using MIC versus usual care. For MIC, medication selection was informed by the NMR (normal ≥0.31 vs. slow <0.31). The primary outcomes were intervention satisfaction and match rates between NMR and medication choice.
RESULTS


The baseline prevalence of smoking in our CD population was 13%. Intervention participants reported high rates of satisfaction (85%) and chose a medication that matched their NMR result more often in the MIC group (100% vs. 64%, p = 0.01). Six of 16 (37.5%) patients prescribed varenicline discontinued due to side effects.
CONCLUSION


MIC produced high rates of satisfaction and matching between NMR and medication in CD patients, supporting patient acceptance and feasibility of precision smoking cessation in this population. To reduce smoking in CD, therapies such as MIC are needed to maximize efficacy and minimize side effects.",2020,"The nicotine metabolite ratio (NMR) predicts cessation success with pharmacotherapy: varenicline doubles cessation over nicotine replacement therapy (NRT) for ""normal"", but not ""slow"" metabolizers.","[""Crohn's disease"", '1098 patients visiting an inflammatory bowel disease center about their smoking history', 'subgroup of individuals with CD (n = 32) who participated in a randomized controlled trial of smoking cessation using MIC versus usual care']","['Varenicline', 'nicotine metabolite ratio (NMR', 'nicotine replacement therapy (NRT', 'varenicline', 'Precision nicotine metabolism-informed care']","['intervention satisfaction and match rates between NMR and medication choice', 'high rates of satisfaction']","[{'cui': 'C0156147', 'cui_str': 'Colitis, Granulomatous'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory Bowel Diseases'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0427978', 'cui_str': 'Minimum Inhibitory Concentration'}]","[{'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0700287', 'cui_str': 'Informing (procedure)'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",1098.0,0.030592,"The nicotine metabolite ratio (NMR) predicts cessation success with pharmacotherapy: varenicline doubles cessation over nicotine replacement therapy (NRT) for ""normal"", but not ""slow"" metabolizers.","[{'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Scoville', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, United States of America.'}, {'ForeName': 'Hilary A', 'Initials': 'HA', 'LastName': 'Tindle', 'Affiliation': 'Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, United States of America.'}, {'ForeName': 'Quinn S', 'Initials': 'QS', 'LastName': 'Wells', 'Affiliation': 'Division of Cardiology, Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, United States of America.'}, {'ForeName': 'Shannon C', 'Initials': 'SC', 'LastName': 'Peyton', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, United States of America.'}, {'ForeName': 'Shelly', 'Initials': 'S', 'LastName': 'Gurwara', 'Affiliation': 'Division of Gastroenterology, Wake Forest School of Medicine, Winston-Salem, North Carolina, United States of America.'}, {'ForeName': 'Stephanie O', 'Initials': 'SO', 'LastName': 'Pointer', 'Affiliation': 'Division of Gastroenterology, The Ohio State University Wexner Medical Center, Columbus, Ohio, United States of America.'}, {'ForeName': 'Sara N', 'Initials': 'SN', 'LastName': 'Horst', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, United States of America.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Schwartz', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, United States of America.'}, {'ForeName': 'Dawn W', 'Initials': 'DW', 'LastName': 'Adams', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, United States of America.'}, {'ForeName': 'Matthew S', 'Initials': 'MS', 'LastName': 'Freiberg', 'Affiliation': 'Geriatric Research Education and Clinical Centers (GRECC), Veterans Affairs Tennessee Valley Healthcare System, Nashville, Tennessee, United States of America.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Gatskie', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center, Nashville, Tennessee, United States of America.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'King', 'Affiliation': 'Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, United States of America.'}, {'ForeName': 'Lesa R', 'Initials': 'LR', 'LastName': 'Abney', 'Affiliation': 'Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, United States of America.'}, {'ForeName': 'Dawn B', 'Initials': 'DB', 'LastName': 'Beaulieu', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, United States of America.'}]",PloS one,['10.1371/journal.pone.0230656']
409,32238335,Effectiveness of One-Way Text Messaging on Attendance to Follow-Up Cervical Cancer Screening Among Human Papillomavirus-Positive Tanzanian Women (Connected2Care): Parallel-Group Randomized Controlled Trial.,"BACKGROUND


Rapid human papillomavirus (HPV) DNA testing is an emerging cervical cancer screening strategy in resource-limited countries, yet it requires follow-up of women who test HPV positive.
OBJECTIVE


This study aimed to determine if one-way text messages improved attendance to a 14-month follow-up cervical cancer screening among HPV-positive women.
METHODS


This multicenter, parallel-group randomized controlled trial was conducted at 3 hospitals in Tanzania. Eligible participants were aged between 25 and 60 years, had tested positive to a rapid HPV test during a patient-initiated screening, had been informed of their HPV result, and had a private mobile phone with a valid number. Participants were randomly assigned in a 1:1 ratio to the intervention or control group through an incorporated algorithm in the text message system. The intervention group received one-way text messages, and the control group received no text messages. The primary outcome was attendance at a 14-month health provider-initiated follow-up screening. Participants were not blinded, but outcome assessors were. The analysis was based on intention to treat.
RESULTS


Between August 2015 and July 2017, 4080 women were screened for cervical cancer, of which 705 were included in this trial-358 women were allocated to the intervention group, and 347 women were allocated to the control group. Moreover, 16 women were excluded before the analysis because they developed cervical cancer or died (8 from each group). In the intervention group, 24.0% (84/350) women attended their follow-up screening, and in the control group, 23.8% (80/335) women attended their follow-up screening (risk ratio 1.02, 95% CI 0.79-1.33).
CONCLUSIONS


Attendance to a health provider-initiated follow-up cervical cancer screening among HPV-positive women was strikingly low, and one-way text messages did not improve the attendance rate. Implementation of rapid HPV testing as a primary screening method at the clinic level entails the challenge of ensuring a proper follow-up of women.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02509702; https://clinicaltrials.gov/ct2/show/NCT02509702.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


RR2-10.2196/10.2196/15863.",2020,"This study aimed to determine if one-way text messages improved attendance to a 14-month follow-up cervical cancer screening among HPV-positive women.
","['16 women were excluded before the analysis because they developed cervical cancer or died (8 from each group', 'Human Papillomavirus-Positive Tanzanian Women', 'Between August 2015 and July 2017', 'Eligible participants were aged between 25 and 60 years, had tested positive to a rapid HPV test during a patient-initiated screening, had been informed of their HPV result, and had a private mobile phone with a valid number', 'Connected2Care', '3 hospitals in Tanzania', '4080 women were screened for cervical cancer, of which 705 were included in this trial-358 women were allocated to the intervention group, and 347 women', 'HPV-positive women']","['control group received no text messages', 'One-Way Text Messaging', 'intervention or control group through an incorporated algorithm in the text message system']","['attendance at a 14-month health provider-initiated follow-up screening', 'attendance rate']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1998726', 'cui_str': 'Is informed'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]",4080.0,0.355157,"This study aimed to determine if one-way text messages improved attendance to a 14-month follow-up cervical cancer screening among HPV-positive women.
","[{'ForeName': 'Ditte S', 'Initials': 'DS', 'LastName': 'Linde', 'Affiliation': 'Department of Clinical Research, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Marianne S', 'Initials': 'MS', 'LastName': 'Andersen', 'Affiliation': 'Department of Medical Endocrinology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Julius', 'Initials': 'J', 'LastName': 'Mwaiselage', 'Affiliation': 'Department for Cancer Prevention Services, Ocean Road Cancer Institute, Dar es Salaam, United Republic of Tanzania.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Manongi', 'Affiliation': 'Department of Public Health, Kilimanjaro Christian Medical University College, Moshi, United Republic of Tanzania.'}, {'ForeName': 'Susanne K', 'Initials': 'SK', 'LastName': 'Kjaer', 'Affiliation': 'Department of Gynaecology, Rigshospitalet University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Vibeke', 'Initials': 'V', 'LastName': 'Rasch', 'Affiliation': 'Department of Clinical Research, University of Southern Denmark, Odense, Denmark.'}]",Journal of medical Internet research,['10.2196/15863']
410,30907180,The role of body image changes in neurorehabilitation outcomes: a preliminary study.,"Body representation includes body schema (a plastic and dynamic representation of the body's spatial and biomechanical properties) and body image (a conscious representation of the body, including the functions and relationships of the body parts). The aim of our study is to understand the change of body representation in patients affected by Acquired Brain Injury (ABI),  undergoing  a program that integrates psychological and nutritional support. Forty patients with ABI diagnosis were enrolled in this study and randomized into either the control (CG:n = 20) or the experimental (EG:n = 20) group. The EG underwent psychological counselling (PC) focused on the perception of body schema and on the reduction of depressive symptoms as well as a Nutritional Counselling (NC) in which all patients had a personalized nutritional plan, based on their needs once a week for 6 months. In contrast, the CG received only a nutritional treatment. Results show that the combined PC-NC approach encouraged change in body representation, the reconstruction of body image and improved mood. In conclusion, our data demonstrates that patients with ABI undergoing the combined approach can improve the perception of their body schema, mood and therapeutic compliance.",2020,"Results show that the combined PC-NC approach encouraged change in body representation, the reconstruction of body image and improved mood.","['patients with ABI', 'Forty patients with ABI diagnosis', 'patients affected by Acquired Brain Injury (ABI), undergoing a program that integrates psychological and nutritional support']","['control (CG:n\xa0=\xa020) or the experimental (EG:n\xa0=\xa020) group', 'psychological counselling (PC']","['body representation, the reconstruction of body image and improved mood', 'perception of their body schema, mood and therapeutic compliance']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0522476', 'cui_str': 'Patient affected (contextual qualifier) (qualifier value)'}, {'cui': 'C0270611', 'cui_str': 'Brain Injuries'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0242739', 'cui_str': 'Nutritional Support'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0474178', 'cui_str': 'Psychological counseling'}]","[{'cui': 'C3489573', 'cui_str': 'Body Representation'}, {'cui': 'C0524865', 'cui_str': 'Reconstructive Surgery'}, {'cui': 'C0005891', 'cui_str': 'Body Image'}, {'cui': 'C4508986', 'cui_str': 'Improved mood'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C3489574', 'cui_str': 'Body Schema'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C4319828', 'cui_str': 'Therapeutic Compliance'}]",40.0,0.0160246,"Results show that the combined PC-NC approach encouraged change in body representation, the reconstruction of body image and improved mood.","[{'ForeName': 'Giuseppa', 'Initials': 'G', 'LastName': 'Maresca', 'Affiliation': ""Behavioral and Robotic Neurorehabilitation Unit, IRCCS Centro Neurolesi 'Bonino Pulejo', Messina, Italy.""}, {'ForeName': 'Maria Grazia', 'Initials': 'MG', 'LastName': 'Maggio', 'Affiliation': ""Behavioral and Robotic Neurorehabilitation Unit, IRCCS Centro Neurolesi 'Bonino Pulejo', Messina, Italy.""}, {'ForeName': 'Santina', 'Initials': 'S', 'LastName': 'Caliri', 'Affiliation': ""Behavioral and Robotic Neurorehabilitation Unit, IRCCS Centro Neurolesi 'Bonino Pulejo', Messina, Italy.""}, {'ForeName': 'Maria Cristina', 'Initials': 'MC', 'LastName': 'De Cola', 'Affiliation': ""Behavioral and Robotic Neurorehabilitation Unit, IRCCS Centro Neurolesi 'Bonino Pulejo', Messina, Italy.""}, {'ForeName': 'Ileana', 'Initials': 'I', 'LastName': 'Scarcella', 'Affiliation': ""Behavioral and Robotic Neurorehabilitation Unit, IRCCS Centro Neurolesi 'Bonino Pulejo', Messina, Italy.""}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Andaloro', 'Affiliation': ""Behavioral and Robotic Neurorehabilitation Unit, IRCCS Centro Neurolesi 'Bonino Pulejo', Messina, Italy.""}, {'ForeName': 'Desirè', 'Initials': 'D', 'LastName': 'Latella', 'Affiliation': ""Behavioral and Robotic Neurorehabilitation Unit, IRCCS Centro Neurolesi 'Bonino Pulejo', Messina, Italy.""}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Accorinti', 'Affiliation': ""Behavioral and Robotic Neurorehabilitation Unit, IRCCS Centro Neurolesi 'Bonino Pulejo', Messina, Italy.""}, {'ForeName': 'Rosaria', 'Initials': 'R', 'LastName': 'De Luca', 'Affiliation': ""Behavioral and Robotic Neurorehabilitation Unit, IRCCS Centro Neurolesi 'Bonino Pulejo', Messina, Italy.""}, {'ForeName': 'Rocco Salvatore', 'Initials': 'RS', 'LastName': 'Calabrò', 'Affiliation': ""Behavioral and Robotic Neurorehabilitation Unit, IRCCS Centro Neurolesi 'Bonino Pulejo', Messina, Italy.""}]","Psychology, health & medicine",['10.1080/13548506.2019.1597977']
411,32241810,Economic evaluation alongside the Speed of Increasing milk Feeds Trial (SIFT).,"OBJECTIVE


To evaluate the cost-effectiveness of two rates of enteral feed advancement (18 vs 30 mL/kg/day) in very preterm and very low birth weight infants.
DESIGN


Within-trial economic evaluation alongside a multicentre, two-arm parallel group, randomised controlled trial (Speed of Increasing milk Feeds Trial).
SETTING


55 UK neonatal units from May 2013 to June 2015.
PATIENTS


Infants born <32 weeks' gestation or <1500 g, receiving less than 30 mL/kg/day of milk at trial enrolment. Infants with a known severe congenital anomaly, no realistic chance of survival, or unlikely to be traceable for follow-up, were ineligible.
INTERVENTIONS


When clinicians were ready to start advancing feed volumes, infants were randomised to receive daily increments in feed volume of 30 mL/kg (intervention) or 18 mL/kg (control).
MAIN OUTCOME MEASURE


Cost per additional survivor without moderate to severe neurodevelopmental disability at 24 months of age corrected for prematurity.
RESULTS


Average costs per infant were slightly higher for faster feeds compared with slower feeds (mean difference £267, 95% CI -6928 to 8117). Fewer infants achieved the principal outcome of survival without moderate to severe neurodevelopmental disability at 24 months in the faster feeds arm (802/1224 vs 848/1246). The stochastic cost-effectiveness analysis showed a likelihood of worse outcomes for faster feeds compared with slower feeds.
CONCLUSIONS


The stochastic cost-effectiveness analysis shows faster feeds are broadly equivalent on cost grounds. However, in terms of outcomes at 24 months age (corrected for prematurity), faster feeds are harmful. Faster feeds should not be recommended on either cost or effectiveness grounds to achieve the primary outcome.",2020,Fewer infants achieved the principal outcome of survival without moderate to severe neurodevelopmental disability at 24 months in the faster feeds arm (802/1224 vs 848/1246).,"[""Infants born <32 weeks' gestation or <1500 g, receiving less than 30 mL/kg/day of milk at trial enrolment"", 'Infants with a known severe congenital anomaly, no realistic chance of survival, or unlikely to be traceable for follow-up, were ineligible', 'very preterm and very low birth weight infants', '55 UK neonatal units from May 2013 to June 2015']",['enteral feed advancement'],"['cost-effectiveness', 'survival without moderate to severe neurodevelopmental disability', 'Cost per additional survivor without moderate to severe neurodevelopmental disability']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C1532579', 'cui_str': 'mL/kg/day'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0282667', 'cui_str': 'Very low birth weight infant'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0439148', 'cui_str': 'Unit'}]","[{'cui': 'C0086225', 'cui_str': 'Enteral feeding'}, {'cui': 'C0441478', 'cui_str': 'Surgical advancement - action'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]",,0.240684,Fewer infants achieved the principal outcome of survival without moderate to severe neurodevelopmental disability at 24 months in the faster feeds arm (802/1224 vs 848/1246).,"[{'ForeName': 'Warda', 'Initials': 'W', 'LastName': 'Tahir', 'Affiliation': 'University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Monahan', 'Affiliation': 'University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Dorling', 'Affiliation': 'Division of Neonatal-Perinatal Medicine, Dalhousie University-Faculty of Medicine, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Hewer', 'Affiliation': 'National Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford, Oxfordshire, UK.'}, {'ForeName': 'Ursula', 'Initials': 'U', 'LastName': 'Bowler', 'Affiliation': 'National Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford, Oxfordshire, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Linsell', 'Affiliation': 'National Perinatal epidemiology Unit, University of Oxford, Oxford, UK.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Partlett', 'Affiliation': 'Faculty of Medicine & Health Sciences, University of Nottingham, Nottingham, Nottinghamshire, UK.'}, {'ForeName': 'Janet Elizabeth', 'Initials': 'JE', 'LastName': 'Berrington', 'Affiliation': 'Neonatology, Royal Victoria Infirmary, Newcastle upon Tyne, UK.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Boyle', 'Affiliation': 'Department of Health Sciences, University of Leicester, Leicester, UK.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Embleton', 'Affiliation': 'Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Johnson', 'Affiliation': 'University of Leicester, Leicester, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Leaf', 'Affiliation': 'Neonatal Medicine, Southmead Hospital, Bristol, UK.'}, {'ForeName': 'Kenny', 'Initials': 'K', 'LastName': 'McCormick', 'Affiliation': 'John Radcliffe Hospital, Oxford, Oxfordshire, UK.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'McGuire', 'Affiliation': 'Centre for Reviews and Dissemination, University of York, York, North Yorkshire, UK.'}, {'ForeName': 'Ben J', 'Initials': 'BJ', 'LastName': 'Stenson', 'Affiliation': 'Neonatology, Neonatal Unit, Simpson Centre for Reproductive Health, Royal Infirmary of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Ed', 'Initials': 'E', 'LastName': 'Juszczak', 'Affiliation': 'Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Tracy E', 'Initials': 'TE', 'LastName': 'Roberts', 'Affiliation': 'Health Economics Unit, Institute of Applied Health Research, University of Birmingham, Birmingham, UK t.e.roberts@bham.ac.uk.'}]",Archives of disease in childhood. Fetal and neonatal edition,['10.1136/archdischild-2019-318346']
412,31307836,"Comparison of hemoglobin and hematocrit levels at 1, 4 and 24 h after red blood cell transfusion.","Previous studies have shown that equilibration following a red cell transfusion had occurred by 24 h. A shorter time to follow the hemoglobin (Hb) and hematocrit (Hct) after transfusion may help physicians to provide earlier and more pertinent treatment. This was a prospective study conducted from December 2014 to August 2015. This research aimed to determine the equilibration time point of the level of Hb and Hct after one unit red blood cell (RBC) transfusion. Patients were randomized into three groups and Hb level and Hct were assessed at one, four or 24 h after transfusion. The mean differences in Hb level and Hct before and after transfusion were compared between each group. Sixty patients were eligible for enrollment onto this study; 20 patients were therefore allocated to each group. The median age was 51 years old, male predominating (83.33%). The most common indication for transfusion was post-operative anemia (88.33%). There were no significant differences between the baseline characteristics baseline Hb, Hct and volume of RBC transfusion in each group. The mean differences in Hb (g/dl)/Hct (%) level at the different time points of one, four and 24 h were 1.21/3.62, 1.19/3.63, and 0.95/3.09 respectively (P = 0.109 and P = 0.398, respectively). The equilibration of Hb and Hct did not differ between one, four and 24 h after a RBC transfusion. The target Hb and Hct can be determined at one hour after transfusion.",2020,"There were no significant differences between the baseline characteristics baseline Hb, Hct and volume of RBC transfusion in each group.","['Sixty patients were eligible for enrollment onto this study; 20 patients', 'from December 2014 to August 2015', 'The median age was 51 years old, male predominating (83.33']",[],"['hemoglobin (Hb) and hematocrit (Hct', 'hemoglobin and hematocrit levels', 'baseline characteristics baseline Hb, Hct and volume of RBC transfusion', 'equilibration of Hb and Hct']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0332251', 'cui_str': 'Predominate (qualifier value)'}]",[],"[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0518014', 'cui_str': 'Hematocrit - finding'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0014792', 'cui_str': 'Blood Corpuscles, Red'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}]",60.0,0.0275947,"There were no significant differences between the baseline characteristics baseline Hb, Hct and volume of RBC transfusion in each group.","[{'ForeName': 'Krittadhee', 'Initials': 'K', 'LastName': 'Karndumri', 'Affiliation': 'Department of Internal Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Adisak', 'Initials': 'A', 'LastName': 'Tantiworawit', 'Affiliation': 'Division of Hematology, Department of Internal Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand. Electronic address: adisak.tan@cmu.ac.th.'}, {'ForeName': 'Sasinee', 'Initials': 'S', 'LastName': 'Hantrakool', 'Affiliation': 'Division of Hematology, Department of Internal Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Kanda', 'Initials': 'K', 'LastName': 'Fanhchaksai', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Ekarat', 'Initials': 'E', 'LastName': 'Rattarittamrong', 'Affiliation': 'Division of Hematology, Department of Internal Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Atikun', 'Initials': 'A', 'LastName': 'Limsukon', 'Affiliation': 'Division of Pulmonology, Department of Internal Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Dumnoensun', 'Initials': 'D', 'LastName': 'Pruksakorn', 'Affiliation': 'Department of Orthopedics, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Sompit', 'Initials': 'S', 'LastName': 'Karndumri', 'Affiliation': 'Nursing Services Division, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Thanawat', 'Initials': 'T', 'LastName': 'Rattanathammethee', 'Affiliation': 'Division of Hematology, Department of Internal Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Chatree', 'Initials': 'C', 'LastName': 'Chai-Adisaksopha', 'Affiliation': 'Division of Hematology, Department of Internal Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Lalita', 'Initials': 'L', 'LastName': 'Norasetthada', 'Affiliation': 'Division of Hematology, Department of Internal Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}]",Transfusion and apheresis science : official journal of the World Apheresis Association : official journal of the European Society for Haemapheresis,['10.1016/j.transci.2019.06.021']
413,32273250,3D Printing Technology Improves Medical Interns' Understanding of Anatomy of Gastrocolic Trunk.,"OBJECTIVE


Complex vascular anatomy has always been a difficult point for medical students. Gastrocolic trunk (Henle trunk) has many branches and variations, involving the venous reflux of the stomach, right colon, and pancreas. This study investigated the effects of 3 dimensional (3D) printing technology on medical interns' understanding of Henle trunk's variation, by comparing 2 dimensional (2D) images.
SETTING


Henle trunk modes were manufactured using 3D-CT angiography and 3D-printing technology.
PARTICIPANTS


Forty-seven interns from 2 medical schools (Nanjing Medical University and Medical College of Nantong University) participated in the study.
DESIGN


The interns were divided randomly allocated into 2 groups, where group 1 was the control group with a 2D image of Henle trunk plus surgical video (named 2D image group), and group 2 was the study group with a 3D printed model of Henle trunk plus surgical video (named 3D-printing group). Knowledge of interns on the Henle trunk was compared between 2 groups using a question test before and after the teaching intervention.
RESULTS


All interns had an improved overall assessment score as a result of attending the seminar, whether in the 2D image group or the 3D-printing group. The score of the 2D image group increased 32.57 ± 13.86, and the 3D-printing group increased 47.04 ± 12.99, showing significant difference (p = 0.001). There was no significant difference observed between postseminar scores between 2 medical schools (p = 0.975). There was a significant improvement in satisfaction among the 3D-printing group for education depth, novel and inspiring of teaching method, except for the interaction between teacher and interns (p = 0.215). Interns hope to have more teaching time for 3D printing, and not satisfied with the time of 3D printing teaching compared with those in the 2D image group (p = 0.021).
CONCLUSIONS


The 3-D printed Henle trunk model is a very effective teaching tool, which can help interns understand the anatomy of Henle trunk. The application of 3D printing technology in the teaching of interns of complex vascular anatomy is worth popularizing in teaching hospitals.",2020,"There was a significant improvement in satisfaction among the 3D-printing group for education depth, novel and inspiring of teaching method, except for the interaction between teacher and interns (p = 0.215).",['Forty-seven interns from 2 medical schools (Nanjing Medical University and Medical College of Nantong University) participated in the study'],"['Gastrocolic trunk (Henle trunk', '3 dimensional (3D) printing technology', '3D-CT angiography and 3D-printing technology', 'control group with a 2D image of Henle trunk plus surgical video (named 2D image group), and group 2 was the study group with a 3D printed model of Henle trunk plus surgical video (named 3D-printing group', '3D Printing Technology']","['postseminar scores', 'satisfaction', 'overall assessment score']","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0036378', 'cui_str': 'Medical School'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0033161', 'cui_str': 'Printing'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C1536105', 'cui_str': 'CT angiography'}, {'cui': 'C3849992', 'cui_str': 'Three-Dimensional Printing'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0027365', 'cui_str': 'Name'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}]",47.0,0.0189232,"There was a significant improvement in satisfaction among the 3D-printing group for education depth, novel and inspiring of teaching method, except for the interaction between teacher and interns (p = 0.215).","[{'ForeName': 'Yigang', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': ""Department of General Surgery, The Affiliated Wuxi No. 2 People's Hospital of Nanjing Medical University, Jiangsu, PR China.""}, {'ForeName': 'Chunxiang', 'Initials': 'C', 'LastName': 'Qian', 'Affiliation': ""Department of Education and Researching, The Affiliated Wuxi No. 2 People's Hospital of Nanjing Medical University, Jiangsu, PR China.""}, {'ForeName': 'Ruizhi', 'Initials': 'R', 'LastName': 'Shen', 'Affiliation': ""Department of Oncology, The Affiliated Wuxi No. 2 People's Hospital of Nanjing Medical University, Jiangsu, PR China.""}, {'ForeName': 'Danping', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': ""Department of Radiology, The Affiliated Wuxi No. 2 People's Hospital of Nanjing Medical University, Jiangsu, PR China.""}, {'ForeName': 'Linjie', 'Initials': 'L', 'LastName': 'Bian', 'Affiliation': ""Department of Radiology, The Affiliated Wuxi No. 2 People's Hospital of Nanjing Medical University, Jiangsu, PR China.""}, {'ForeName': 'Huiheng', 'Initials': 'H', 'LastName': 'Qu', 'Affiliation': ""Department of General Surgery, The Affiliated Wuxi No. 2 People's Hospital of Nanjing Medical University, Jiangsu, PR China.""}, {'ForeName': 'Xinqi', 'Initials': 'X', 'LastName': 'Fan', 'Affiliation': ""Department of General Surgery, The Affiliated Wuxi No. 2 People's Hospital of Nanjing Medical University, Jiangsu, PR China.""}, {'ForeName': 'Zhequn', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Harbin JunYang Technology Co., Ltd., Harbin, PR China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""Department of Education and Researching, The Affiliated Wuxi No. 2 People's Hospital of Nanjing Medical University, Jiangsu, PR China. Electronic address: 19952266966@189.cn.""}, {'ForeName': 'Jiazeng', 'Initials': 'J', 'LastName': 'Xia', 'Affiliation': ""Department of General Surgery, The Affiliated Wuxi No. 2 People's Hospital of Nanjing Medical University, Jiangsu, PR China. Electronic address: xjz_wuxi@alumni.sjtu.edu.cn.""}]",Journal of surgical education,['10.1016/j.jsurg.2020.02.031']
414,31594870,"Multicentre, randomised controlled trial of adjuvant chemotherapy in cervical cancer with residual human papilloma virus DNA following primary radiotherapy or chemoradiotherapy: a study protocol.","INTRODUCTION


The role of adjuvant chemotherapy after radical radiotherapy (RT) or chemoradiotherapy (CRT) in cervical cancer awaits further confirmation. Evidences have shown that persistent human papilloma virus (HPV) DNA in exfoliated cell post-RT is a potential biomarker of subclinical residual disease and thus increases the risk of recurrence. In this prospective, multicentre, randomised controlled trial, we will use HPV DNA in exfoliated cell to identify patients with cervical cancer who received definitive RT or CRT with higher risk of relapse for adjuvant chemotherapy.
METHODS AND ANALYSIS


Eligible patients with histologically confirmed cervical cancer stage IIA2 to IVA of the International Federation of Gynaecology and Obstetrics, adequate organ function and no locoregional disease or distant metastasis after completion of primary treatment will be screened for HPV DNA in exfoliated cell at 1 month post-RT. Patients with undetectable HPV DNA will undergo standard surveillance. Patients with detectable HPV DNA will be randomly assigned to either adjuvant chemotherapy with docetaxel and nedaplatin for four cycles (arm 1) or observation (arm 2). Patients will be stratified for primary treatment (RT vs CRT). The primary endpoint is relapse-free survival.
ETHICS AND DISSEMINATION


This protocol received a favourable ethical opinion from the Ethics Committee of the Second Affiliated Hospital of Fujian Medical University on 6 February, 2018, (No. 28). The trial results will be published in peer-reviewed journals and presented in conferences. A summary of the findings will be made available to participants.
TRIAL REGISTRATION NUMBER


ChiCTR-IIR-17012655; Pre-results.",2019,The role of adjuvant chemotherapy after radical radiotherapy (RT) or chemoradiotherapy (CRT) in cervical cancer awaits further confirmation.,"['Eligible patients with histologically confirmed cervical cancer stage IIA2 to IVA of the International Federation of Gynaecology and Obstetrics, adequate organ function and no locoregional disease or distant metastasis after completion of primary treatment will be screened for HPV DNA in exfoliated cell at 1\u2009month post-RT', 'cervical cancer with residual human papilloma virus DNA following primary', 'Patients with detectable HPV DNA', 'patients with cervical cancer who received definitive RT or CRT with higher risk of relapse for adjuvant chemotherapy']","['adjuvant chemotherapy', 'HPV DNA', 'adjuvant chemotherapy with docetaxel and nedaplatin', 'adjuvant chemotherapy after radical radiotherapy (RT) or chemoradiotherapy (CRT', 'radiotherapy or chemoradiotherapy']",['relapse-free survival'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix (disorder)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1269798', 'cui_str': 'pM category'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}, {'cui': 'C0237849', 'cui_str': 'Scaling of skin'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0443196', 'cui_str': 'Definitive (qualifier value)'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}]","[{'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0093999', 'cui_str': 'nedaplatin'}, {'cui': 'C0439807', 'cui_str': 'Radical - extent'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.241898,The role of adjuvant chemotherapy after radical radiotherapy (RT) or chemoradiotherapy (CRT) in cervical cancer awaits further confirmation.,"[{'ForeName': 'Yanhong', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Radiotherapy Department, The Second Affiliated Hospital of Fujian Medical University, Quanzhou, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Ouyang', 'Affiliation': 'Radiotherapy Department, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Jingjing', 'Initials': 'J', 'LastName': 'Su', 'Affiliation': 'Radiotherapy Department, The Second Affiliated Hospital of Fujian Medical University, Quanzhou, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Gynecology Department, Fujian Provincial Tumor Hospital, Fuzhou, China.'}, {'ForeName': 'Qunrong', 'Initials': 'Q', 'LastName': 'Cai', 'Affiliation': 'Radiotherapy Department, The Second Affiliated Hospital of Fujian Medical University, Quanzhou, China.'}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Xu', 'Affiliation': 'Gynecology Department, Fujian Provincial Tumor Hospital, Fuzhou, China.'}, {'ForeName': 'Zhigang', 'Initials': 'Z', 'LastName': 'Bai', 'Affiliation': 'Radiotherapy Department, The Second Affiliated Hospital of Fujian Medical University, Quanzhou, China.'}, {'ForeName': 'Xinping', 'Initials': 'X', 'LastName': 'Cao', 'Affiliation': 'Radiotherapy Department, Sun Yat-sen University Cancer Center, Guangzhou, China caoxp@sysucc.org.cn.'}]",BMJ open,['10.1136/bmjopen-2018-028171']
415,31594876,"Simvastatin as a neuroprotective treatment for Parkinson's disease (PD STAT): protocol for a double-blind, randomised, placebo-controlled futility study.","INTRODUCTION


Parkinson's disease (PD) is a progressive neurodegenerative condition affecting approximately 185,000 people in the UK. No drug has been proven to slow disease progression. Epidemiological and pre-clinical data support simvastatin, a widely used cholesterol-lowering drug with a well-established safety profile, having neuroprotective properties. The aim of this study (Simvastatin as a neuroprotective treatment for PD (PD STAT)) is to determine whether simvastatin has the potential to slow PD progression. The study is part of the International Linked Clinical Trials initiative coordinated by The Cure Parkinson's Trust. This paper describes the protocol for the PD STAT study.
METHODS AND ANALYSIS


PD STAT is a double-blind, randomised, placebo-controlled, multi-centre, parallel group, futility trial in patients with PD of mild-moderate severity. 235 participants have been recruited and randomly allocated in a 1:1 ratio to receive either oral simvastatin or matched placebo. Treatment involves a 1-month low-dose phase (40 mg daily), followed by a 23-month high-dose phase (80 mg daily) and ends with a 2-month washout period. Participants are reviewed at clinic visits at 1 month, 6, 12, 18, 24 and 26 months post-baseline, with interim telephone follow-up to monitor for adverse events.The primary outcome is the change in the Movement Disorder Society Unified Parkinson's Disease Rating Scale part III motor subscale score in the practically defined OFF medication state (OFF state) between baseline and 24 months. Primary analysis will be on a modified intention to treat basis and will include only those participants who progress to the high-dose phase of the study.
ETHICS AND DISSEMINATION


The protocol has been approved by the North East-Newcastle and North Tyneside 2 Research Ethics Committee. The results will be disseminated via research articles in peer-reviewed journals and presentations at local, national and international scientific meetings, as well as disseminated via patient groups, websites and networks. A summary of the study findings will be posted to participants at the end of the study.
TRIAL REGISTRATION


ISRCTN16108482 (prospectively registered); EudraCT 2015-000148-40; ClinicalTrials.gov NCT02787590; Pre-results.",2019,Disease Rating Scale part III motor subscale score in the practically defined OFF medication state (OFF state) between baseline and 24 months.,"['patients with PD of mild-moderate severity', ""Parkinson's disease (PD STAT"", 'Participants are reviewed at clinic visits at 1 month, 6, 12, 18, 24 and 26 months post-baseline, with interim telephone follow-up to monitor for adverse events', 'PD (PD STAT', '235 participants']","['placebo', 'simvastatin', 'Simvastatin', 'oral simvastatin or matched placebo']","['Disease Rating Scale part III motor subscale score', ""change in the Movement Disorder Society Unified Parkinson's""]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0205548', 'cui_str': 'Stat (qualifier value)'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0178941', 'cui_str': 'Telephone follow-up'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0074554', 'cui_str': 'Simvastatin'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0222045'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0459443', 'cui_str': 'Subscale score (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0026650', 'cui_str': 'Movement Disorder Syndromes'}, {'cui': 'C0037455', 'cui_str': 'Societies'}]",235.0,0.33511,Disease Rating Scale part III motor subscale score in the practically defined OFF medication state (OFF state) between baseline and 24 months.,"[{'ForeName': 'Camille B', 'Initials': 'CB', 'LastName': 'Carroll', 'Affiliation': 'Faculty of Medicine and Dentistry, University of Plymouth, Plymouth, UK camille.carroll@plymouth.ac.uk.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Webb', 'Affiliation': 'Peninsula Clinical Trials Unit, University of Plymouth, Plymouth, UK.'}, {'ForeName': 'Kara Nicola', 'Initials': 'KN', 'LastName': 'Stevens', 'Affiliation': 'Medical Statistics Group, University of Plymouth, Plymouth, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Vickery', 'Affiliation': 'Peninsula Clinical Trials Unit, University of Plymouth, Plymouth, UK.'}, {'ForeName': 'Vicky', 'Initials': 'V', 'LastName': 'Eyre', 'Affiliation': 'Peninsula Clinical Trials Unit, University of Plymouth, Plymouth, UK.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Ball', 'Affiliation': 'NIHR CLAHRC South West Peninsula (PenCLAHRC), University of Exeter Medical School, Exeter, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Wyse', 'Affiliation': ""The Cure Parkinson's Trust, London, UK.""}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Webber', 'Affiliation': 'PPI Representative, University of Plymouth, Plymouth, UK.'}, {'ForeName': 'Andy', 'Initials': 'A', 'LastName': 'Foggo', 'Affiliation': 'PPI Representative, University of Plymouth, Plymouth, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Zajicek', 'Affiliation': 'School of Medicine, University of St Andrews, St Andrews, UK.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Whone', 'Affiliation': 'School of Translational Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Siobhan', 'Initials': 'S', 'LastName': 'Creanor', 'Affiliation': 'Medical Statistics Group, University of Plymouth, Plymouth, UK.'}]",BMJ open,['10.1136/bmjopen-2019-029740']
416,31991135,Aortic Insufficiency After Left Ventricular Assist Device Implantation: Predictors and Outcomes.,"BACKGROUND


The aim of this study was to evaluate the incidence, risk factors, and clinical impact of progression of aortic insufficiency (AI) after left ventricular assist device (LVAD) implantation.
METHODS


Patients undergoing primary durable LVAD implantation between 2004 and 2018 were included. Significant AI was defined as more than mild AI. Clinical and echocardiographic data were collected. Patients were stratified by degree of pre-LVAD AI into 3 groups: no AI, group I; trace AI, group II; and mild AI, group III.
RESULTS


Three hundred sixteen eligible patients underwent LVAD implant, 229 patients (72.5%) in group I, 54 (17.1%) in group II, and 33 (10.4%) in group III. Median follow-up was 469 days. Forty-two patients (13.3%) progressed to significant AI during follow-up. Group III patients had the highest rate of developing significant AI (I, 10.0%; II, 13.0%; III, 36.4%; P = .002). Freedom from significant AI at 1 year after LVAD implant was 94.5% in group I, 86.1% in group II, and 62.4% in group III (P < .001). Predictors of developing significant AI included mild preoperative AI, ischemic cardiomyopathy, and shorter duration of LVAD support. Patients with significant AI after LVAD implantation had higher mortality compared with those without (59.5% vs 37.2%; P = .006).
CONCLUSIONS


Although some patients supported with an LVAD develop significant AI, this risk is increased in those with mild AI preoperatively. This finding, in conjunction with the increased mortality risk once significant AI develops, suggests that closer follow-up and management of LVAD patients with mild preoperative AI may be prudent.",2020,"Patients with significant AI after LVAD had higher mortality compared to those without (59.5% vs 37.2%; p=0.006).
","['Patients undergoing primary durable LVAD implantation between 2004-2018 were included', '316 eligible patients underwent LVAD implant, including 229 (72.5%) patients in group']","['left ventricular assist device (LVAD) implantation', 'Left Ventricular Assist Device Implantation']","['higher mortality', 'Aortic Insufficiency', 'highest rate of developing significant AI', 'mild preoperative AI, ischemic cardiomyopathy, and shorter duration of LVAD support']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0450356', 'cui_str': '316'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0003504', 'cui_str': 'Aortic Incompetence'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0349782', 'cui_str': 'Generalized ischemic myocardial dysfunction (disorder)'}, {'cui': 'C0439593', 'cui_str': 'Short duration (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]",316.0,0.0272134,"Patients with significant AI after LVAD had higher mortality compared to those without (59.5% vs 37.2%; p=0.006).
","[{'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Kagawa', 'Affiliation': 'Division of Cardiac Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania; Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Edgar', 'Initials': 'E', 'LastName': 'Aranda-Michel', 'Affiliation': 'Division of Cardiac Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania; Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Kormos', 'Affiliation': 'Division of Cardiac Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania; Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Keebler', 'Affiliation': 'Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania; Division of Cardiology, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Hickey', 'Affiliation': 'Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania; Division of Cardiology, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Yisi', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Mathier', 'Affiliation': 'Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania; Division of Cardiology, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Arman', 'Initials': 'A', 'LastName': 'Kilic', 'Affiliation': 'Division of Cardiac Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania; Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania. Electronic address: kilica2@upmc.edu.'}]",The Annals of thoracic surgery,['10.1016/j.athoracsur.2019.12.030']
417,31996581,Minimal Open Hemorrhoidectomy Versus Transanal Hemorrhoidal Dearterialization: The Effect on Symptoms: An Open-Label Randomized Controlled Trial.,"BACKGROUND


There is limited evidence on the long-term efficacy of transanal hemorrhoidal dearterialization compared with hemorrhoidectomy. Most studies investigated short-term effects with postoperative pain as the primary outcome. Being a benign disease, the long-term goal of treatment for hemorrhoids is the resolution of symptoms and improvement of quality of life.
OBJECTIVE


The purpose of this study was to compare the effect of minimal open hemorrhoidectomy versus transanal hemorrhoidal dearterialization on patient-reported symptoms.
DESIGN


This was an open-label randomized controlled trial.
SETTINGS


This was a single-center study.
PATIENTS


Patients with symptomatic hemorrhoids grade II to IV (Goligher's classification) were included.
INTERVENTIONS


Patients were randomly allocated to minimal open hemorrhoidectomy or transanal hemorrhoidal dearterialization.
MAIN OUTCOME MEASURES


The primary outcome was symptoms assessed by the Hemorrhoidal Disease Symptom Score 1 year postoperatively. Secondary outcomes included health-related quality of life, patient satisfaction, postoperative pain and recovery, adverse events, recurrence, and hospital costs.
RESULTS


Forty-eight patients received minimal open hemorrhoidectomy, and 50 patients received transanal hemorrhoidal dearterialization. No difference in symptom score at 1-year follow-up was found. Median (range) symptom score was 3 (0-17) after minimal open hemorrhoidectomy and 5 (0-17) after transanal hemorrhoidal dearterialization (median difference = -1.0 (95% CI, -3.0 to 0.0); p = 0.15). Residual hemorrhoidal prolapse was reported more frequently (p = 0.008), and more patients had treatment for recurrence after transanal hemorrhoidal dearterialization (7 vs 0 patients; p = 0.013). Patient satisfaction was higher after minimal open hemorrhoidectomy (p = 0.049). No differences were found in the impact on health-related quality of life, average and peak postoperative pain, recovery, or adverse events (p > 0.05). Transanal hemorrhoidal dearterialization was more expensive (median difference = &OV0556;555 (95% CI, &OV0556;472-&OV0556;693); p < 0.001).
LIMITATIONS


No blinding was included in this study.
CONCLUSION


No difference was found in symptom score 1 year postoperatively. Minimal open hemorrhoidectomy had a better effect on the hemorrhoidal prolapse and higher patient satisfaction. More patients needed treatment for recurrence after transanal hemorrhoidal dearterialization. Minimal open hemorrhoidectomy has an immediate postoperative course similar to transanal hemorrhoidal dearterialization. See Video Abstract at http://links.lww.com/DCR/B152.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT02061176. HEMORROIDECTOMíA MíNIMA ABIERTA VERSUS DESARTERIALIZACIóN HEMORROIDAL TRANSANAL: EL EFECTO SOBRE LOS SíNTOMAS: UN ESTUDIO ABIERTO CONTROLADO Y ALEATORIZADO: Hay evidencia limitada sobre la eficacia a largo plazo de la desarterialización hemorroidal transanal en comparación con la hemorroidectomía. La mayoría de los estudios han investigado los efectos a corto plazo con el dolor postoperatorio como el resultado primario. Al ser una enfermedad benigna, el objetivo a largo plazo del tratamiento de la enfermedad hemorroidal es la resolución de los síntomas y la mejora en la calidad de vida.Comparar el efecto de la hemorroidectomía abierta mínima versus la desarterialización hemorroidal transanal en los síntomas reportados por el paciente.Ensayo controlado aleatorizado abierto.Estudio en sede única.Pacientes con enfermedad hemorroidal sintomática de grado II-IV (clasificación de Goligher).Los pacientes fueron asignados aleatoriamente a hemorroidectomía mínima abierta o desarterialización hemorroidal transanal.El resultado primario fueron los síntomas evaluados por el Score de Síntomas de Enfermedad Hemorroidal un año después de la operación. Los resultados secundarios incluyeron calidad de vida relacionada con la salud, satisfacción del paciente, dolor y recuperación postoperatorios, eventos adversos, recurrencia y costos hospitalarios.Cuarenta y ocho pacientes recibieron hemorroidectomía abierta mínima y cincuenta pacientes recibieron desarterialización hemorroidal transanal. No se encontraron diferencias en la puntuación de los síntomas al año de seguimiento. La puntuación mediana (rango) de síntomas fue 3 (0-17) después de una hemorroidectomía mínima abierta y 5 (0-17) después de la desarterialización hemorroidal transanal (diferencia mediana [IC95%]: -1.0 [-3.0-0.0], p = 0.15). El prolapso hemorroidal residual se informó con mayor frecuencia (p = 0.008) y más pacientes recibieron tratamiento por recurrencia después de la desarterialización hemorroidal transanal (7 frente a 0 pacientes, p = 0.013). La satisfacción del paciente fue mayor después de una hemorroidectomía abierta mínima (p = 0.049). No se encontraron diferencias en el impacto sobre la calidad de vida relacionada con la salud, el dolor postoperatorio promedio y máximo, la recuperación o los eventos adversos (p> 0.05). La desarterialización hemorroidal transanal fue más costosa (diferencia mediana [IC95%]: &OV0556; 555 [472-693], p <0.001).Estudio sin cegamiento.No se encontraron diferencias en la puntuación de los síntomas a un año después de la operación. La hemorroidectomía mínima abierta tuvo un mejor efecto sobre el prolapso hemorroidal y una mayor satisfacción del paciente. Más pacientes necesitaron tratamiento para la recurrencia después de la desarterialización hemorroidal transanal. La hemorroidectomía abierta mínima tiene un curso postoperatorio inmediato similar a la desarterialización hemorroidal transanal. Consulte Video Resumen en http://links.lww.com/DCR/B152. (Traducción-Dr. Jorge Silva Velazco).ClinicalTrials.gov Identifier: NCT02061176.",2020,"No differences were found in the impact on health-related quality of life, average and peak postoperative pain, recovery, or adverse events (p>0.05).","[""Patients with symptomatic hemorrhoids grade II-IV (Goligher's classification"", 'Single-center study']","['minimal open hemorrhoidectomy', 'hemorrhoidectomy', 'Transanal Hemorrhoidal Dearterialization', 'Transanal hemorrhoidal dearterialization', 'transanal hemorrhoidal dearterialization', 'minimal open hemorrhoidectomy versus transanal hemorrhoidal dearterialization', 'Minimal Open Hemorrhoidectomy', 'minimal open hemorrhoidectomy or transanal hemorrhoidal dearterialization']","['health-related quality of life, average and peak postoperative pain, recovery, or adverse events', 'symptom score', 'Hemorrhoidal Disease Symptom Score one year postoperatively', 'Residual hemorrhoidal prolapse', 'Patient satisfaction', 'Median (range) symptom score', 'hemorrhoidal prolapse and higher patient satisfaction', 'health-related quality of life, patient satisfaction, postoperative pain and recovery, adverse events, recurrence and hospital costs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0019112', 'cui_str': 'Hemorrhoids'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0008903', 'cui_str': 'taxonomy'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C0473074', 'cui_str': 'Open hemorrhoidectomy (procedure)'}, {'cui': 'C0019108', 'cui_str': 'Hemorrhoidectomy'}, {'cui': 'C0589371', 'cui_str': 'Transanal approach (qualifier value)'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0206174', 'cui_str': 'Hospital Costs'}]",,0.0743887,"No differences were found in the impact on health-related quality of life, average and peak postoperative pain, recovery, or adverse events (p>0.05).","[{'ForeName': 'Håvard D', 'Initials': 'HD', 'LastName': 'Rørvik', 'Affiliation': ''}, {'ForeName': 'André H', 'Initials': 'AH', 'LastName': 'Campos', 'Affiliation': 'Department of Surgery, Holbaek Hospital, Holbaek, Denmark.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Styr', 'Affiliation': 'Department of Surgery, Holbaek Hospital, Holbaek, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Ilum', 'Affiliation': 'Department of Surgery, Holbaek Hospital, Holbaek, Denmark.'}, {'ForeName': 'Grant K', 'Initials': 'GK', 'LastName': 'McKinstry', 'Affiliation': 'Department of Surgery, Holbaek Hospital, Holbaek, Denmark.'}, {'ForeName': 'Birgitte', 'Initials': 'B', 'LastName': 'Brandstrup', 'Affiliation': 'Department of Surgery, Holbaek Hospital, Holbaek, Denmark.'}, {'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Olaison', 'Affiliation': 'Department of Surgery, Holbaek Hospital, Holbaek, Denmark.'}]",Diseases of the colon and rectum,['10.1097/DCR.0000000000001588']
418,32269148,Continuous neurally adjusted ventilation: a feasibility study in preterm infants.,"OBJECTIVES


To assess the feasibility and tolerance of NeuroPAP, a new non-invasive ventilation mode which continuously adjusts (during both inspiration and expiration) the pressure support proportionally to the diaphragm electrical activity (Edi), in preterm infants and to evaluate the impact on ventilation pressure and Edi.
DESIGN


Prospective cross-over single-centre feasibility study.
SETTING


One level 3 neonatal intensive care unit in Canada.
PATIENTS


Stable preterm infants ventilated with non-invasive positive pressure ventilation (NIPPV).
INTERVENTIONS


Subjects were successively ventilated in NIPPV with prestudy settings (30 min), in NeuroPAP with minimal pressure similar to NIPPV PEEP (positive end-expiratory pressure) (60 min), in NeuroPAP with minimal pressure reduced by 2 cmH 2 0 (60 min), in continuous positive airway pressure (15 min) and again in NIPPV (30 min). Main outcome measures included tolerance, ventilation pressure, Edi and patient-ventilator synchrony.
RESULTS


Twenty infants born at 28.0±1.0 weeks were included. NeuroPAP was well tolerated and could be delivered during 100% of planned period. During NeuroPAP, the PEEP was continuously adjusted proportionally to tonic diaphragm Edi, although the average PEEP value was similar to the set minimal pressure. During NeuroPAP, 83 (78-86)% breaths were well synchronised vs 9 (6-12)% breaths during NIPPV (p<0.001).
CONCLUSIONS


NeuroPAP is feasible and well tolerated in stable preterm infants, and it allows transient adaptation in PEEP in response to tonic diaphragm electrical activity changes. Further studies are warranted to determine the impact of these findings on clinical outcomes.
TRIAL REGISTRATION NUMBER


NCT02480205.",2020,"During NeuroPAP, 83 (78-86)% breaths were well synchronised vs 9 (6-12)% breaths during NIPPV (p<0.001).
","['stable preterm infants', 'Stable preterm infants ventilated with non-invasive positive pressure ventilation (NIPPV', 'preterm infants', 'One level 3 neonatal intensive care unit in Canada', 'Twenty infants born at 28.0±1.0 weeks were included']","['Subjects were successively ventilated in NIPPV with prestudy settings (30 min), in NeuroPAP with minimal pressure similar to NIPPV PEEP (positive end-expiratory pressure) (60 min), in NeuroPAP with minimal pressure reduced by 2 cmH 2 0 (60 min), in continuous positive airway pressure (15 min) and again in NIPPV', 'Continuous neurally adjusted ventilation', 'NeuroPAP']","['average PEEP value', 'tonic diaphragm', 'tolerance, ventilation pressure, Edi and patient-ventilator synchrony', 'ventilation pressure and Edi']","[{'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C0021778', 'cui_str': 'Intermittent positive pressure ventilation'}, {'cui': 'C0456949', 'cui_str': 'Level 3'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0949658', 'cui_str': 'Primary familial hypertrophic cardiomyopathy'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}]","[{'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C3543842', 'cui_str': 'TONICS'}, {'cui': 'C0011980', 'cui_str': 'Diaphragm structure'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}]",,0.0625725,"During NeuroPAP, 83 (78-86)% breaths were well synchronised vs 9 (6-12)% breaths during NIPPV (p<0.001).
","[{'ForeName': 'Marie-Eve', 'Initials': 'ME', 'LastName': 'Rochon', 'Affiliation': 'Department of Pediatrics, CHU Sainte-Justine, Montreal, Quebec, Canada.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Lodygensky', 'Affiliation': 'Department of Pediatrics, CHU Sainte-Justine, Montreal, Quebec, Canada.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Tabone', 'Affiliation': 'Department of Pediatrics, CHU Sainte-Justine, Montreal, Quebec, Canada.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Essouri', 'Affiliation': 'Department of Pediatrics, CHU Sainte-Justine, Montreal, Quebec, Canada.'}, {'ForeName': 'Sylvain', 'Initials': 'S', 'LastName': 'Morneau', 'Affiliation': 'Department of Pediatrics, CHU Sainte-Justine, Montreal, Quebec, Canada.'}, {'ForeName': 'Christer', 'Initials': 'C', 'LastName': 'Sinderby', 'Affiliation': ""Critical illness and injury research center, Keenan Research Center for Biomedical Science of St-Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Beck', 'Affiliation': ""Keenan Research Centre, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Emeriaud', 'Affiliation': 'Department of Pediatrics, CHU Sainte-Justine, Montreal, Quebec, Canada guillaume.emeriaud@umontreal.ca.'}]",Archives of disease in childhood. Fetal and neonatal edition,['10.1136/archdischild-2019-318660']
419,32172039,Manipulating sleep duration perception changes cognitive performance - An exploratory analysis.,"OBJECTIVES


To test the effect of perceived sleep duration on cognitive performance.
METHODS


Sixteen healthy individuals [8F; mean age (± SD): 24.2 ± 3.0 years)] received an 8-h sleep opportunity followed by a 5-h opportunity on two consecutive nights. Upon waking, they were randomized to being informed that they received either an 8-h or 5-h sleep opportunity, via a clock that ran either fast, slow or normally. Cognitive performance was assessed using 10-min auditory psychomotor vigilance tests and subjective sleepiness ratings. Homeostatic and circadian sleep drive was assessed using waking electroencephalography (EEG).
RESULTS


Reaction time was significantly quicker when individuals thought that they had slept for 8 h but given a 5-h sleep opportunity. Conversely, reaction times were significantly slower when individuals thought they had 5 h of sleep but given an 8-h sleep opportunity. EEG delta power (1.0-4.5 Hz) during wake increased significantly when sleep was restricted to 5 h, and individuals thought they slept for 5 h, but this increase was attenuated with a perceived sleep duration of 8 h following a 5-h opportunity. EEG delta power did not increase, however, with perceived sleep restriction. EEG high-alpha activity (10.5-11.5 Hz) was consistently higher when participants thought that they had an 8-h sleep opportunity, regardless of the actual duration.
CONCLUSIONS


These results suggest that perceived sleep duration may modulate psychosomatic responses. Additional studies with predefined outcomes and analyses are necessary to confirm these findings, which may have important implications for understanding how sleep affects cognition and psychosomatic responses.",2020,"EEG delta power (1.0-4.5 Hz) during wake increased significantly when sleep was restricted to 5 h, and individuals thought they slept for 5 h, but this increase was attenuated with a perceived sleep duration of 8 h following a 5-h opportunity.",['Sixteen healthy individuals [8F; mean age (± SD): 24.2\xa0±\xa03.0\xa0years'],[],"['Homeostatic and circadian sleep drive', 'EEG high-alpha activity', 'reaction times', 'Cognitive performance', '10-min auditory psychomotor vigilance tests and subjective sleepiness ratings', 'EEG delta power', 'Reaction time']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",[],"[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0013819', 'cui_str': 'EEG'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}]",16.0,0.0585712,"EEG delta power (1.0-4.5 Hz) during wake increased significantly when sleep was restricted to 5 h, and individuals thought they slept for 5 h, but this increase was attenuated with a perceived sleep duration of 8 h following a 5-h opportunity.","[{'ForeName': 'Shadab A', 'Initials': 'SA', 'LastName': 'Rahman', 'Affiliation': ""Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital, Boston, MA 02115, United States of America; Division of Sleep Medicine, Harvard Medical School, Boston, MA 02115, United States of America. Electronic address: sarahman@rics.bwh.harvard.edu.""}, {'ForeName': 'Dharmishta', 'Initials': 'D', 'LastName': 'Rood', 'Affiliation': 'Department of Psychology, Harvard University, Cambridge, MA 02139, United States of America.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Trent', 'Affiliation': 'Department of Psychology, Harvard University, Cambridge, MA 02139, United States of America.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Solet', 'Affiliation': 'Division of Sleep Medicine, Harvard Medical School, Boston, MA 02115, United States of America; Department of Medicine, Cambridge Health Alliance, Cambridge, MA 02139, United States of America.'}, {'ForeName': 'Ellen J', 'Initials': 'EJ', 'LastName': 'Langer', 'Affiliation': 'Department of Psychology, Harvard University, Cambridge, MA 02139, United States of America.'}, {'ForeName': 'Steven W', 'Initials': 'SW', 'LastName': 'Lockley', 'Affiliation': ""Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital, Boston, MA 02115, United States of America; Division of Sleep Medicine, Harvard Medical School, Boston, MA 02115, United States of America.""}]",Journal of psychosomatic research,['10.1016/j.jpsychores.2020.109992']
420,32222762,Comparison of DNA methylation patterns of parentally imprinted genes in placenta derived from IVF conceptions in two different culture media.,"STUDY QUESTION


Is there a difference in DNA methylation status of imprinted genes in placentas derived from IVF conceptions where embryo culture was performed in human tubal fluid (HTF) versus G5 culture medium?
SUMMARY ANSWER


We found no statistically significant differences in the mean DNA methylation status of differentially methylated regions (DMRs) associated with parentally imprinted genes in placentas derived from IVF conceptions cultured in HTF versus G5 culture medium.
WHAT IS KNOWN ALREADY


Animal studies indicate that the embryo culture environment affects the DNA methylation status of the embryo. In humans, birthweight is known to be affected by the type of embryo culture medium used. The effect of embryo culture media on pregnancy, birth and child development may thus be mediated by differential methylation of parentally imprinted genes in the placenta.
STUDY DESIGN, SIZE, DURATION


To identify differential DNA methylation of imprinted genes in human placenta derived from IVF conceptions exposed to HTF or G5 embryo culture medium, placenta samples (n = 43 for HTF, n = 54 for G5) were collected between 2010 and 2012 s as part of a multi-center randomized controlled trial in the Netherlands comparing these embryo culture media. Placenta samples from 69 naturally conceived (NC) live births were collected during 2008-2013 in the Netherlands as reference material.
PARTICIPANTS/MATERIALS, SETTING, METHODS


To identify differential DNA methylation of imprinted genes, we opted for an amplicon-based sequencing strategy on an Illumina MiSeq sequencing platform. DNA was isolated and 34 DMRs associated with well-defined parentally imprinted genes were amplified in a two-step PCR before sequencing using MiSeq technology. Sequencing data were analyzed in a multivariate fashion to eliminate possible confounding effects.
MAIN RESULTS AND THE ROLE OF CHANCE


We found no statistically significant differences in the mean DNA methylation status of any of the imprinted DMRs in placentas derived from IVF conceptions cultured in HTF or G5 culture medium. We also did not observe any differences in the mean methylation status per amplicon nor in the variance in methylation per amplicon between the two culture medium.
groups. A separate surrogate variable analysis also demonstrated that the IVF culture medium was not associated with the DNA methylation status of these DMRs. The mean methylation level and variance per CpG was equal between HTF and G5 placenta. Additional comparison of DNA methylation status of NC placenta samples revealed no statistically significant differences in mean amplicon and CpG methylation between G5, HTF and NC placenta; however, the number of placenta samples exhibiting outlier methylation levels was higher in IVF placenta compared to NC (P < 0.00001). Also, we were able to identify 37 CpG sites that uniquely displayed outlier methylation in G5 placentas and 32 CpG sites that uniquely displayed outlier methylation in HTF. In 8/37 (G5) and 4/32 (HTF) unique outliers CpGs, a medium-specific unique outlier could be directly correlated to outlier methylation of the entire amplicon.
LIMITATIONS, REASONS FOR CAUTION


Due to practical reasons, not all placentas were collected during the trial, and we collected the placentas from natural conceptions from a different cohort, potentially creating bias. We limited ourselves to the DNA methylation status of 34 imprinted DMRs, and we studied only the placenta and no other embryo-derived tissues.
WIDER IMPLICATIONS OF THE FINDINGS


It has often been postulated, but has yet to be rigorously tested, that imprinting mediates the effects of embryo culture conditions on pregnancy, birth and child development in humans. Since we did not detect any statistically significant effects of embryo culture conditions on methylation status of imprinted genes in the placenta, this suggests that other unexplored mechanisms may underlie these effects. The biological and clinical relevance of detected outliers with respect to methylation levels of CpGs and DMR require additional analysis in a larger sample size as well. Given the importance and the growing number of children born through IVF, research into these molecular mechanisms is urgently needed.
STUDY FUNDING/COMPETING INTEREST(S)


This study was funded by the March of Dimes grant number #6-FY13-153. The authors have no conflicts of interest.
TRIAL REGISTRATION NUMBER


Placental biopsies were obtained under Netherlands Trial Registry number 1979 and 1298.",2020,We found no statistically significant differences in the mean DNA methylation status of any of the imprinted DMRs in placentas derived from IVF conceptions cultured in HTF or G5 culture medium.,"['To identify differential DNA methylation of imprinted genes', 'imprinted genes in human placenta derived from IVF conceptions exposed to HTF or G5 embryo culture medium, placenta samples (n\xa0=\u200943 for HTF, n\xa0', '54 for G5) were collected between 2010 and 2012', 'Placenta samples from 69 naturally conceived (NC) live births were collected during 2008-2013 in the Netherlands as reference material']",['embryo culture media'],"['mean methylation level and variance per CpG', 'number of placenta samples exhibiting outlier methylation levels', 'mean amplicon and CpG methylation', 'mean DNA methylation status', 'mean DNA methylation status of differentially methylated regions (DMRs']","[{'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0443199', 'cui_str': 'Differential (qualifier value)'}, {'cui': 'C0376452', 'cui_str': 'DNA Methylation'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0032043', 'cui_str': 'Placentome'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C0009637', 'cui_str': 'Conception'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0013935', 'cui_str': 'Embryo'}, {'cui': 'C0010454', 'cui_str': 'Culture Media'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0481667', 'cui_str': 'Live Birth'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}]","[{'cui': 'C0013935', 'cui_str': 'Embryo'}, {'cui': 'C0010454', 'cui_str': 'Culture Media'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0025723', 'cui_str': 'Methylation'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0032043', 'cui_str': 'Placentome'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0015272', 'cui_str': 'Exhibits'}, {'cui': 'C0376452', 'cui_str': 'DNA Methylation'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}]",,0.164727,We found no statistically significant differences in the mean DNA methylation status of any of the imprinted DMRs in placentas derived from IVF conceptions cultured in HTF or G5 culture medium.,"[{'ForeName': 'Callista L', 'Initials': 'CL', 'LastName': 'Mulder', 'Affiliation': 'Center for Reproductive Medicine, Amsterdam Reproduction & Development Research Institute, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, 1105 AZ Amsterdam, the Netherlands.'}, {'ForeName': 'Tess M', 'Initials': 'TM', 'LastName': 'Wattimury', 'Affiliation': 'Center for Reproductive Medicine, Amsterdam Reproduction & Development Research Institute, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, 1105 AZ Amsterdam, the Netherlands.'}, {'ForeName': 'Aldo', 'Initials': 'A', 'LastName': 'Jongejan', 'Affiliation': 'Bioinformatics Laboratory, Clinical Epidemiology, Biostatistics and Bioinformatics, Amsterdam Public Health Research Institute, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, 1105 AZ Amsterdam, the Netherlands.'}, {'ForeName': 'Cindy M', 'Initials': 'CM', 'LastName': 'de Winter-Korver', 'Affiliation': 'Center for Reproductive Medicine, Amsterdam Reproduction & Development Research Institute, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, 1105 AZ Amsterdam, the Netherlands.'}, {'ForeName': 'Saskia K M', 'Initials': 'SKM', 'LastName': 'van Daalen', 'Affiliation': 'Center for Reproductive Medicine, Amsterdam Reproduction & Development Research Institute, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, 1105 AZ Amsterdam, the Netherlands.'}, {'ForeName': 'Robert B', 'Initials': 'RB', 'LastName': 'Struijk', 'Affiliation': 'Center for Reproductive Medicine, Amsterdam Reproduction & Development Research Institute, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, 1105 AZ Amsterdam, the Netherlands.'}, {'ForeName': 'Susanne C M', 'Initials': 'SCM', 'LastName': 'Borgman', 'Affiliation': 'Center for Reproductive Medicine, Amsterdam Reproduction & Development Research Institute, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, 1105 AZ Amsterdam, the Netherlands.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Wurth', 'Affiliation': 'Center for Reproductive Medicine, St. Elisabeth-TweeSteden Hospital, Hilvarenbeekseweg 60, 5022 GC, Tilburg, the Netherlands.'}, {'ForeName': 'Dimitri', 'Initials': 'D', 'LastName': 'Consten', 'Affiliation': 'Center for Reproductive Medicine, St. Elisabeth-TweeSteden Hospital, Hilvarenbeekseweg 60, 5022 GC, Tilburg, the Netherlands.'}, {'ForeName': 'Jannie', 'Initials': 'J', 'LastName': 'van Echten-Arends', 'Affiliation': 'Section of Reproductive Medicine, Department of Obstetrics and Gynecology, University Medical Center Groningen, University of Groningen, Hanzeplein 1, 9713 GZ, Groningen, the Netherlands.'}, {'ForeName': 'Sebastiaan', 'Initials': 'S', 'LastName': 'Mastenbroek', 'Affiliation': 'Center for Reproductive Medicine, Amsterdam Reproduction & Development Research Institute, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, 1105 AZ Amsterdam, the Netherlands.'}, {'ForeName': 'John C M', 'Initials': 'JCM', 'LastName': 'Dumoulin', 'Affiliation': 'Department of Obstetrics & Gynaecology, GROW School for Oncology and Developmental Biology, Maastricht University Medical Center, P Debyelaan 25, 6229 GX, Maastricht, the Netherlands.'}, {'ForeName': 'Sjoerd', 'Initials': 'S', 'LastName': 'Repping', 'Affiliation': 'Center for Reproductive Medicine, Amsterdam Reproduction & Development Research Institute, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, 1105 AZ Amsterdam, the Netherlands.'}, {'ForeName': 'Ans M M', 'Initials': 'AMM', 'LastName': 'van Pelt', 'Affiliation': 'Center for Reproductive Medicine, Amsterdam Reproduction & Development Research Institute, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, 1105 AZ Amsterdam, the Netherlands.'}, {'ForeName': 'Aafke P A', 'Initials': 'APA', 'LastName': 'van Montfoort', 'Affiliation': 'Department of Obstetrics & Gynaecology, GROW School for Oncology and Developmental Biology, Maastricht University Medical Center, P Debyelaan 25, 6229 GX, Maastricht, the Netherlands.'}]","Human reproduction (Oxford, England)",['10.1093/humrep/deaa004']
421,32049772,Clinic-Based Pediatric Disclosure Intervention Trial Improves Pediatric HIV Status Disclosure in Ghana.,"BACKGROUND


Disclosing HIV status to HIV-positive children is a major challenge facing families and health care providers. Despite recommendations for disclosure, rates remain low. We tested whether a pediatric HIV disclosure intervention delivered as an integral component of routine HIV health care in Ghana would improve disclosure to children.
METHODS


Dyads of HIV-infected children aged 7-18 years and their caregivers were enrolled from 2 HIV clinics in Accra and Kumasi, Ghana. The sites were randomly assigned to one of the 2 intervention arms to avoid treatment contamination between intervention and control participants. Trained interventionist used theory-guided therapeutic communication and personalized interaction to promote disclosure. Disclosure outcomes were measured at 12-week intervals. All analyses were completed using a modified intention-to-treat approach.
RESULTS


We enrolled 446 child-caregiver dyads (N = 240 intervention group; N = 206 control group); 52% of the children were boys, mean age 9.78 (±2.27) years. For disclosure at 1 year, a better overall treatment effect was observed (P < 0.001). Children in the treatment group had greater disclosure at each time point (P < 0.001) and a higher proportion of them had been disclosed to by 1 year (51.4% vs. 16.2%; P < 0.001; un-adjusted hazard ratio = 3.98: 95% confidence interval: 2.63 to 6.03) and 3 years (71.3% vs. 34.0%; unadjusted hazard ratio = 4.21: 95% confidence interval: 3.09 to 5.72). In the multivariate Cox model, factors associated with disclosure were treatment group (P < 0.001), children <11 years of age (P < 0.001), HIV-infected caregivers (P = 0.015), and caregiver's with greater education (P = 0.022).
CONCLUSIONS


This practical clinic-based disclosure intervention shows excellent promise as a means of improving HIV pediatric disclosure outcomes.",2020,"Children in the treatment group had greater disclosure at each time point (p<0.001) and a higher proportion of them had been disclosed to by 1 year (51.4% vs 16.2%; p<0.001; un-adjusted HR=3.98: 95% CI, 2.63, 6.03) and 3 years (71.3% vs 34.0%; unadjusted HR=4.21: 95% CI, 3.09, 5.72).","['Dyads of HIV-infected children aged 7 to 18 years and their caregivers were enrolled from two HIV clinics in Accra and Kumasi, Ghana', 'We enrolled 446 child-caregiver dyads (N=240 intervention group; N=206 control group); 52% of the children were male, mean age 9.78 (±2.27) years', 'Pediatric HIV Status Disclosure in Ghana']",['pediatric HIV disclosure intervention'],"['greater disclosure', 'Disclosure outcomes']","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0017516', 'cui_str': 'Republic of Ghana'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0458074', 'cui_str': 'HIV status'}, {'cui': 'C0012625', 'cui_str': 'Information Disclosure'}]","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0012625', 'cui_str': 'Information Disclosure'}]","[{'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0012625', 'cui_str': 'Information Disclosure'}]",446.0,0.205796,"Children in the treatment group had greater disclosure at each time point (p<0.001) and a higher proportion of them had been disclosed to by 1 year (51.4% vs 16.2%; p<0.001; un-adjusted HR=3.98: 95% CI, 2.63, 6.03) and 3 years (71.3% vs 34.0%; unadjusted HR=4.21: 95% CI, 3.09, 5.72).","[{'ForeName': 'Elijah', 'Initials': 'E', 'LastName': 'Paintsil', 'Affiliation': 'Department of Pediatrics, Yale School of Medicine, New Haven, CT.'}, {'ForeName': 'Tassos C', 'Initials': 'TC', 'LastName': 'Kyriakides', 'Affiliation': 'Yale Center for Analytical Sciences, Yale School of Public Health, New Haven, CT.'}, {'ForeName': 'Sampson', 'Initials': 'S', 'LastName': 'Antwi', 'Affiliation': 'Department of Child Health, School of Medical Sciences, Kwame Nkrumah University of Science and Technology and Komfo Anokye Teaching Hospital, Kumasi, Ghana.'}, {'ForeName': 'Lorna', 'Initials': 'L', 'LastName': 'Renner', 'Affiliation': 'Department of Child Health, University of Ghana School of Medicine and Dentistry and Korle-Bu Teaching Hospital, Accra, Ghana.'}, {'ForeName': 'Justin S', 'Initials': 'JS', 'LastName': 'Nichols', 'Affiliation': 'Department of Pediatrics, Yale School of Medicine, New Haven, CT.'}, {'ForeName': 'Kofi', 'Initials': 'K', 'LastName': 'Amissah', 'Affiliation': 'Department of Child Health, School of Medical Sciences, Kwame Nkrumah University of Science and Technology and Komfo Anokye Teaching Hospital, Kumasi, Ghana.'}, {'ForeName': 'Jonas T', 'Initials': 'JT', 'LastName': 'Kusah', 'Affiliation': 'Department of Child Health, University of Ghana School of Medicine and Dentistry and Korle-Bu Teaching Hospital, Accra, Ghana.'}, {'ForeName': 'Amina', 'Initials': 'A', 'LastName': 'Alhassan', 'Affiliation': 'Department of Child Health, School of Medical Sciences, Kwame Nkrumah University of Science and Technology and Komfo Anokye Teaching Hospital, Kumasi, Ghana.'}, {'ForeName': 'Irene P', 'Initials': 'IP', 'LastName': 'Ofori', 'Affiliation': 'Department of Child Health, School of Medical Sciences, Kwame Nkrumah University of Science and Technology and Komfo Anokye Teaching Hospital, Kumasi, Ghana.'}, {'ForeName': 'Ann C', 'Initials': 'AC', 'LastName': 'Catlin', 'Affiliation': 'Department of Research Computing, Rosen Center for Advanced Computing, Purdue University, West Lafayette, IN.'}, {'ForeName': 'Geliang', 'Initials': 'G', 'LastName': 'Gan', 'Affiliation': 'Yale Center for Analytical Sciences, Yale School of Public Health, New Haven, CT.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Lartey', 'Affiliation': 'Department of Medicine, University of Ghana School of Medicine and Dentistry and Korle-Bu Teaching Hospital, Accra, Ghana.'}, {'ForeName': 'Nancy R', 'Initials': 'NR', 'LastName': 'Reynolds', 'Affiliation': 'Johns Hopkins School of Nursing, Baltimore, MD.'}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002316']
422,31483448,Patterns of Recurrence After Resection of Pancreatic Ductal Adenocarcinoma: A Secondary Analysis of the ESPAC-4 Randomized Adjuvant Chemotherapy Trial.,"Importance


The patterns of disease recurrence after resection of pancreatic ductal adenocarcinoma with adjuvant chemotherapy remain unclear.
Objective


To define patterns of recurrence after adjuvant chemotherapy and the association with survival.
Design, Setting, and Participants


Prospectively collected data from the phase 3 European Study Group for Pancreatic Cancer 4 adjuvant clinical trial, an international multicenter study. The study included 730 patients who had resection and adjuvant chemotherapy for pancreatic cancer. Data were analyzed between July 2017 and May 2019.
Interventions


Randomization to adjuvant gemcitabine or gemcitabine plus capecitabine.
Main Outcomes and Measures


Overall survival, recurrence, and sites of recurrence.
Results


Of the 730 patients, median age was 65 years (range 37-81 years), 414 were men (57%), and 316 were women (43%). The median follow-up time from randomization was 43.2 months (95% CI, 39.7-45.5 months), with overall survival from time of surgery of 27.9 months (95% CI, 24.8-29.9 months) with gemcitabine and 30.2 months (95% CI, 25.8-33.5 months) with the combination (HR, 0.81; 95% CI, 0.68-0.98; P = .03). The 5-year survival estimates were 17.1% (95% CI, 11.6%-23.5%) and 28.0% (22.0%-34.3%), respectively. Recurrence occurred in 479 patients (65.6%); another 78 patients (10.7%) died without recurrence. Local recurrence occurred at a median of 11.63 months (95% CI, 10.05-12.19 months), significantly different from those with distant recurrence with a median of 9.49 months (95% CI, 8.44-10.71 months) (HR, 1.21; 95% CI, 1.01-1.45; P = .04). Following recurrence, the median survival was 9.36 months (95% CI, 8.08-10.48 months) for local recurrence and 8.94 months (95% CI, 7.82-11.17 months) with distant recurrence (HR, 0.89; 95% CI, 0.73-1.09; P = .27). The median overall survival of patients with distant-only recurrence (23.03 months; 95% CI, 19.55-25.85 months) or local with distant recurrence (23.82 months; 95% CI, 17.48-28.32 months) was not significantly different from those with only local recurrence (24.83 months; 95% CI, 22.96-27.63 months) (P = .85 and P = .35, respectively). Gemcitabine plus capecitabine had a 21% reduction of death following recurrence compared with monotherapy (HR, 0.79; 95% CI, 0.64-0.98; P = .03).
Conclusions and Relevance


There were no significant differences between the time to recurrence and subsequent and overall survival between local and distant recurrence. Pancreatic cancer behaves as a systemic disease requiring effective systemic therapy after resection.
Trial Registration


ClinicalTrials.gov identifier: NCT00058201, EudraCT 2007-004299-38, and ISRCTN 96397434.",2019,"Conclusions and Relevance


There were no significant differences between the time to recurrence and subsequent and overall survival between local and distant recurrence.","[' median age was 65 years (range 37-81 years), 414 were men (57%), and 316 were women (43', '730 patients who had resection and adjuvant chemotherapy for pancreatic cancer', 'Pancreatic Ductal Adenocarcinoma', '730 patients']","['Gemcitabine plus capecitabine', 'gemcitabine', 'gemcitabine or gemcitabine plus capecitabine']","['local recurrence', 'median overall survival', 'Measures\n\n\nOverall survival, recurrence, and sites of recurrence', 'overall survival', 'median survival', 'death following recurrence', 'local with distant recurrence', 'time to recurrence and subsequent and overall survival', 'Recurrence', 'distant recurrence', 'median follow-up time', 'Local recurrence', '5-year survival estimates']","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C4517771', 'cui_str': 'Four hundred and fourteen'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0450356', 'cui_str': '316'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0346647', 'cui_str': 'Cancer of Pancreas'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}]","[{'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}]","[{'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C2945843', 'cui_str': 'Site of (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0443203', 'cui_str': 'Distant (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}]",730.0,0.440122,"Conclusions and Relevance


There were no significant differences between the time to recurrence and subsequent and overall survival between local and distant recurrence.","[{'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Jones', 'Affiliation': 'The Royal Liverpool University Hospital, Liverpool, England.'}, {'ForeName': 'Eftychia-Eirini', 'Initials': 'EE', 'LastName': 'Psarelli', 'Affiliation': 'University of Liverpool, Liverpool, England.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Jackson', 'Affiliation': 'University of Liverpool, Liverpool, England.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Ghaneh', 'Affiliation': 'The Royal Liverpool University Hospital, Liverpool, England.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Halloran', 'Affiliation': 'The Royal Liverpool University Hospital, Liverpool, England.'}, {'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'Palmer', 'Affiliation': 'University of Liverpool, Liverpool, England.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Campbell', 'Affiliation': 'The Royal Liverpool University Hospital, Liverpool, England.'}, {'ForeName': 'Juan W', 'Initials': 'JW', 'LastName': 'Valle', 'Affiliation': 'University of Manchester/The Christie, Manchester, England.'}, {'ForeName': 'Olusola', 'Initials': 'O', 'LastName': 'Faluyi', 'Affiliation': 'The Clatterbridge Cancer Centre, Wirral, England.'}, {'ForeName': 'Derek A', 'Initials': 'DA', 'LastName': ""O'Reilly"", 'Affiliation': 'Manchester University Foundation Trust, Manchester, England.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cunningham', 'Affiliation': 'Royal Marsden Hospital, London, England.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Wadsley', 'Affiliation': 'Weston Park Hospital, Sheffield, England.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Darby', 'Affiliation': 'Weston Park Hospital, Sheffield, England.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Meyer', 'Affiliation': 'Royal Free Hospital, London, England.'}, {'ForeName': 'Roopinder', 'Initials': 'R', 'LastName': 'Gillmore', 'Affiliation': 'Royal Free Hospital, London, England.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Anthoney', 'Affiliation': ""St. James's University Hospital, Leeds, England.""}, {'ForeName': 'Pehr', 'Initials': 'P', 'LastName': 'Lind', 'Affiliation': 'Clinical Research Sörmland, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Bengt', 'Initials': 'B', 'LastName': 'Glimelius', 'Affiliation': 'Clinical Research Sörmland, University of Uppsala, Uppsala, Sweden.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Falk', 'Affiliation': 'Bristol Haematology and Oncology Centre, Bristol, England.'}, {'ForeName': 'Jakob R', 'Initials': 'JR', 'LastName': 'Izbicki', 'Affiliation': 'University of Hamburg Medical Institutions UKE, Hamburg, Germany.'}, {'ForeName': 'Gary William', 'Initials': 'GW', 'LastName': 'Middleton', 'Affiliation': 'Royal Surrey County Hospital, Guildford, England.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Cummins', 'Affiliation': 'Royal Surrey County Hospital, Guildford, England.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Ross', 'Affiliation': ""Guy's Hospital, London, England.""}, {'ForeName': 'Harpreet', 'Initials': 'H', 'LastName': 'Wasan', 'Affiliation': 'Hammersmith Hospital, London, England.'}, {'ForeName': 'Alec', 'Initials': 'A', 'LastName': 'McDonald', 'Affiliation': 'The Beatson West of Scotland Cancer Centre, Glasgow, Scotland.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Crosby', 'Affiliation': 'Velindre Hospital, Cardiff, Wales.'}, {'ForeName': 'Yuk', 'Initials': 'Y', 'LastName': 'Ting', 'Affiliation': 'Queen Elizabeth Hospital, Birmingham, England.'}, {'ForeName': 'Kinnari', 'Initials': 'K', 'LastName': 'Patel', 'Affiliation': 'Churchill Hospital, Oxford, England.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Sherriff', 'Affiliation': 'Derriford Hospital, Plymouth, England.'}, {'ForeName': 'Rubin', 'Initials': 'R', 'LastName': 'Soomal', 'Affiliation': 'Jersey General Hospital, Jersey, England.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Borg', 'Affiliation': 'Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'Sharmila', 'Initials': 'S', 'LastName': 'Sothi', 'Affiliation': 'University Hospital Coventry, Coventry, England.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Hammel', 'Affiliation': 'Hôpital Beaujon, Clichy, France.'}, {'ForeName': 'Markus M', 'Initials': 'MM', 'LastName': 'Lerch', 'Affiliation': 'Greifswald University, Medicine, Greifswald, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Mayerle', 'Affiliation': 'Greifswald University, Medicine, Greifswald, Germany.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Tjaden', 'Affiliation': 'University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Strobel', 'Affiliation': 'University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Thilo', 'Initials': 'T', 'LastName': 'Hackert', 'Affiliation': 'University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Markus W', 'Initials': 'MW', 'LastName': 'Büchler', 'Affiliation': 'University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Neoptolemos', 'Affiliation': 'University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA surgery,['10.1001/jamasurg.2019.3337']
423,31263013,Effectiveness of Nursing Interventions to Prevent Dry Eye in Critically Ill Patients.,"BACKGROUND


Critically ill patients are susceptible to the development of dry eye. Few studies have been conducted on how to best prevent and treat this condition.
OBJECTIVE


To compare the effectiveness of 2 nursing interventions in preventing dry eye in adult intensive care unit patients: liquid artificial tears (Lacribell; Latinofarma) and artificial tears gel (Vidisic Gel; Bausch and Lomb).
METHODS


In this randomized controlled trial, 140 participants were randomly assigned to 1 of 2 treatment groups: a liquid artificial tears group (n = 70) and an artificial tears gel group (n = 70). The study inclusion criteria were as follows: admission to the intensive care unit, age of 18 years or older, no diagnosis of dry eye at admission, receipt of mechanical ventilation, blink rate of less than 5 times per minute, and a score of 7 or less on the Glasgow Coma Scale. On 5 consecutive days, a single researcher who was unaware of the treatment assignment assessed the participants' eyes using the fluorescein eye stain test and the Schirmer test for dry eye.
RESULTS


Dry eye developed in 21% of participants who received liquid artificial tears versus 9% of participants who received artificial tears gel ( P  = .04).
CONCLUSIONS


In this study, artificial tears gel was superior to liquid artificial tears in preventing the development of dry eye. These results may help nurses deliver evidence-based eye care aimed at reducing the risk of dry eye in critically ill patients.",2019,"RESULTS


Dry eye developed in 21% of participants who received liquid artificial tears versus 9% of participants who received artificial tears gel ( P  = .04).
","['140 participants', 'The study inclusion criteria were as follows: admission to the intensive care unit, age of 18 years or older, no diagnosis of dry eye at admission, receipt of mechanical ventilation, blink rate of less than 5 times per minute, and a score of 7 or less on the Glasgow Coma Scale', 'critically ill patients', 'adult intensive care unit patients', 'Critically Ill Patients']","['liquid artificial tears (Lacribell; Latinofarma) and artificial tears gel (Vidisic Gel; Bausch and Lomb', '2 nursing interventions', 'Nursing Interventions', 'fluorescein eye stain test and the Schirmer test for dry eye', 'liquid artificial tears group (n = 70) and an artificial tears gel group']",[],"[{'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0686906', 'cui_str': 'No diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0314719', 'cui_str': 'Dry eyes (finding)'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C0005757', 'cui_str': 'Blinking'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0702093', 'cui_str': '/min'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0017594', 'cui_str': 'Glasgow coma scale (assessment scale)'}, {'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0587445', 'cui_str': 'Adult intensive care unit (environment)'}]","[{'cui': 'C1304698', 'cui_str': 'Liquid - descriptor'}, {'cui': 'C2608262', 'cui_str': 'Lubricating Eye Drops'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C0078237', 'cui_str': 'vidisic'}, {'cui': 'C0028678', 'cui_str': 'nursing care'}, {'cui': 'C0060520', 'cui_str': 'Fluorescein'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0487602', 'cui_str': 'Staining'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0200152', 'cui_str': ""Schirmer's test (procedure)""}, {'cui': 'C0314719', 'cui_str': 'Dry eyes (finding)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]",[],140.0,0.154851,"RESULTS


Dry eye developed in 21% of participants who received liquid artificial tears versus 9% of participants who received artificial tears gel ( P  = .04).
","[{'ForeName': 'Diego Dias', 'Initials': 'DD', 'LastName': 'de Araujo', 'Affiliation': 'Diego Dias de Araujo is assistant professor and Daniel Vinicius Alves Silva, Carolina Amaral Oliveira Rodrigues, and Patricia Oliveira Silva are undergraduate students, Department of Nursing, Universidade Estadual de Montes Claros, Montes Claros, Brazil. Tamara Goncalves Rezende Macieira is a PhD candidate, College of Nursing, University of Florida, Gainesville, Florida. Tania Couto Machado Chianca is professor, School of Nursing, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil. diego.dias1508@gmail.com.'}, {'ForeName': 'Daniel Vinicius Alves', 'Initials': 'DVA', 'LastName': 'Silva', 'Affiliation': 'Diego Dias de Araujo is assistant professor and Daniel Vinicius Alves Silva, Carolina Amaral Oliveira Rodrigues, and Patricia Oliveira Silva are undergraduate students, Department of Nursing, Universidade Estadual de Montes Claros, Montes Claros, Brazil. Tamara Goncalves Rezende Macieira is a PhD candidate, College of Nursing, University of Florida, Gainesville, Florida. Tania Couto Machado Chianca is professor, School of Nursing, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil.'}, {'ForeName': 'Carolina Amaral Oliveira', 'Initials': 'CAO', 'LastName': 'Rodrigues', 'Affiliation': 'Diego Dias de Araujo is assistant professor and Daniel Vinicius Alves Silva, Carolina Amaral Oliveira Rodrigues, and Patricia Oliveira Silva are undergraduate students, Department of Nursing, Universidade Estadual de Montes Claros, Montes Claros, Brazil. Tamara Goncalves Rezende Macieira is a PhD candidate, College of Nursing, University of Florida, Gainesville, Florida. Tania Couto Machado Chianca is professor, School of Nursing, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil.'}, {'ForeName': 'Patricia Oliveira', 'Initials': 'PO', 'LastName': 'Silva', 'Affiliation': 'Diego Dias de Araujo is assistant professor and Daniel Vinicius Alves Silva, Carolina Amaral Oliveira Rodrigues, and Patricia Oliveira Silva are undergraduate students, Department of Nursing, Universidade Estadual de Montes Claros, Montes Claros, Brazil. Tamara Goncalves Rezende Macieira is a PhD candidate, College of Nursing, University of Florida, Gainesville, Florida. Tania Couto Machado Chianca is professor, School of Nursing, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil.'}, {'ForeName': 'Tamara Goncalves Rezende', 'Initials': 'TGR', 'LastName': 'Macieira', 'Affiliation': 'Diego Dias de Araujo is assistant professor and Daniel Vinicius Alves Silva, Carolina Amaral Oliveira Rodrigues, and Patricia Oliveira Silva are undergraduate students, Department of Nursing, Universidade Estadual de Montes Claros, Montes Claros, Brazil. Tamara Goncalves Rezende Macieira is a PhD candidate, College of Nursing, University of Florida, Gainesville, Florida. Tania Couto Machado Chianca is professor, School of Nursing, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil.'}, {'ForeName': 'Tania Couto Machado', 'Initials': 'TCM', 'LastName': 'Chianca', 'Affiliation': 'Diego Dias de Araujo is assistant professor and Daniel Vinicius Alves Silva, Carolina Amaral Oliveira Rodrigues, and Patricia Oliveira Silva are undergraduate students, Department of Nursing, Universidade Estadual de Montes Claros, Montes Claros, Brazil. Tamara Goncalves Rezende Macieira is a PhD candidate, College of Nursing, University of Florida, Gainesville, Florida. Tania Couto Machado Chianca is professor, School of Nursing, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil.'}]","American journal of critical care : an official publication, American Association of Critical-Care Nurses",['10.4037/ajcc2019360']
424,31733631,"Distinct acute effects of LSD, MDMA, and D-amphetamine in healthy subjects.","Lysergic acid diethylamide (LSD) is a classic psychedelic, 3,4-methylenedioxymethamphetamine (MDMA) is an empathogen, and D-amphetamine is a classic stimulant. All three substances are used recreationally. LSD and MDMA are being investigated as medications to assist psychotherapy, and D-amphetamine is used for the treatment of attention-deficit/hyperactivity disorder. All three substances induce distinct acute subjective effects. However, differences in acute responses to these prototypical psychoactive substances have not been characterized in a controlled study. We investigated the acute autonomic, subjective, and endocrine effects of single doses of LSD (0.1 mg), MDMA (125 mg), D-amphetamine (40 mg), and placebo in a randomized, double-blind, cross-over study in 28 healthy subjects. All of the substances produced comparable increases in hemodynamic effects, body temperature, and pupil size, indicating equivalent autonomic responses at the doses used. LSD and MDMA increased heart rate more than D-amphetamine, and D-amphetamine increased blood pressure more than LSD and MDMA. LSD induced significantly higher ratings on the 5 Dimensions of Altered States of Consciousness scale and Mystical Experience Questionnaire than MDMA and D-amphetamine. LSD also produced greater subjective drug effects, ego dissolution, introversion, emotional excitation, anxiety, and inactivity than MDMA and D-amphetamine. LSD also induced greater impairments in subjective ratings of concentration, sense of time, and speed of thinking compared with MDMA and D-amphetamine. MDMA produced greater ratings of good drug effects, liking, high, and ego dissolution compared with D-amphetamine. D-Amphetamine increased ratings of activity and concentration compared with LSD. MDMA but not LSD or D-amphetamine increased plasma concentrations of oxytocin. None of the substances altered plasma concentrations of brain-derived neurotrophic factor. These results indicate clearly distinct acute effects of LSD, MDMA, and D-amphetamine and may assist the dose-finding in substance-assisted psychotherapy research.",2020,LSD induced significantly higher ratings on the 5 Dimensions of Altered States of Consciousness scale and Mystical Experience Questionnaire than MDMA and D-amphetamine.,"['healthy subjects', '28 healthy subjects']","['3,4-methylenedioxymethamphetamine', 'LSD, MDMA, and D-amphetamine', 'LSD', 'MDMA', 'placebo', 'Lysergic acid diethylamide (LSD', 'D-amphetamine, and D-amphetamine', 'D-amphetamine']","['hemodynamic effects, body temperature, and pupil size, indicating equivalent autonomic responses', 'blood pressure', 'subjective ratings of concentration, sense of time, and speed of thinking', 'ratings of activity and concentration', 'plasma concentrations of oxytocin', 'subjective drug effects, ego dissolution, introversion, emotional excitation, anxiety, and inactivity than MDMA and D-amphetamine', 'LSD and MDMA increased heart rate', 'Consciousness scale and Mystical Experience Questionnaire', 'ratings of good drug effects, liking, high, and ego dissolution']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0115471', 'cui_str': 'MDMA'}, {'cui': 'C0024334', 'cui_str': 'LSD'}, {'cui': 'C0011812', 'cui_str': 'dexamfetamine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0886414', 'cui_str': 'Body temperature'}, {'cui': 'C0034121', 'cui_str': 'Pupil'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0728867', 'cui_str': 'Drug action (finding)'}, {'cui': 'C0013712', 'cui_str': 'Ego'}, {'cui': 'C0021924', 'cui_str': 'Introversion'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0115471', 'cui_str': 'MDMA'}, {'cui': 'C0011812', 'cui_str': 'dexamfetamine'}, {'cui': 'C0024334', 'cui_str': 'LSD'}, {'cui': 'C0039231', 'cui_str': 'Tachycardia'}, {'cui': 'C0234421', 'cui_str': 'Consciousness'}, {'cui': 'C0222045'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",28.0,0.0410698,LSD induced significantly higher ratings on the 5 Dimensions of Altered States of Consciousness scale and Mystical Experience Questionnaire than MDMA and D-amphetamine.,"[{'ForeName': 'Friederike', 'Initials': 'F', 'LastName': 'Holze', 'Affiliation': 'Department of Biomedicine and Department of Clinical Research, Division of Clinical Pharmacology and Toxicology, University Hospital Basel, University of Basel, Basel, 4056, Switzerland.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Vizeli', 'Affiliation': 'Department of Biomedicine and Department of Clinical Research, Division of Clinical Pharmacology and Toxicology, University Hospital Basel, University of Basel, Basel, 4056, Switzerland.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Müller', 'Affiliation': 'Psychiatric University Hospital (UPK), University of Basel, Basel, 4012, Switzerland.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Ley', 'Affiliation': 'Department of Biomedicine and Department of Clinical Research, Division of Clinical Pharmacology and Toxicology, University Hospital Basel, University of Basel, Basel, 4056, Switzerland.'}, {'ForeName': 'Raoul', 'Initials': 'R', 'LastName': 'Duerig', 'Affiliation': 'Department of Biomedicine and Department of Clinical Research, Division of Clinical Pharmacology and Toxicology, University Hospital Basel, University of Basel, Basel, 4056, Switzerland.'}, {'ForeName': 'Nimmy', 'Initials': 'N', 'LastName': 'Varghese', 'Affiliation': 'Psychiatric University Hospital (UPK), University of Basel, Basel, 4012, Switzerland.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Eckert', 'Affiliation': 'Psychiatric University Hospital (UPK), University of Basel, Basel, 4012, Switzerland.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Borgwardt', 'Affiliation': 'Psychiatric University Hospital (UPK), University of Basel, Basel, 4012, Switzerland.'}, {'ForeName': 'Matthias E', 'Initials': 'ME', 'LastName': 'Liechti', 'Affiliation': 'Department of Biomedicine and Department of Clinical Research, Division of Clinical Pharmacology and Toxicology, University Hospital Basel, University of Basel, Basel, 4056, Switzerland. matthias.liechti@usb.ch.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0569-3']
425,32233268,Quality of care in an inflammatory bowel disease clinical trial center : a prospective study evaluating patients' satisfaction.,"Background and study aims


Quality of care is a very timely topic in medicine. We designed a questionnaire to measure perceived quality of care and to explore areas of improvement.
Patients and methods


In this prospective study a questionnaire was developed and administered to all patients with inflammatory bowel disease participating in a randomized clinical trial. The questionnaire was based on validated surveys and supplemented with novel, relevant questions. Factors associated with (poor) quality of care were identified.
Results


Between October 2016 and January 2017, all 107 patients participating in a randomized controlled trial completed the questionnaire (63% male, 76% ulcerative colitis, median age of 47 years). The median satisfaction score was 9 out of 10. Areas of improvement were that too little attention was paid to the disease impact on family and work, dietary and exercise pattern, daily activities and quality of life. Multivariate analysis showed that clinical remission [5.77 (2.03-16.39), p=0.001] was a predictor of good quality of care.
Conclusions


In this large IBD trial bureau, inflammatory bowel disease patients were very satisfied with the quality of care. Domains for quality improvement, such as attention to the impact of IBD on family and work, were identified.",2020,"Multivariate analysis showed that clinical remission [5.77 (2.03-16.39), p=0.001] was a predictor of good quality of care.
","['all 107 patients participating in a randomized controlled trial completed the questionnaire (63% male, 76% ulcerative colitis, median age of 47 years', ""patients' satisfaction"", 'patients with inflammatory bowel disease participating in a randomized clinical trial']",[],"['median satisfaction score', 'clinical remission', 'good quality of care', 'Quality of care', 'family and work, dietary and exercise pattern, daily activities and quality of life']","[{'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0009324', 'cui_str': 'Inflammatory Bowel Disease, Ulcerative Colitis Type'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory Bowel Diseases'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}]",[],"[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0034379', 'cui_str': 'Quality of Care'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0034380'}]",107.0,0.0496975,"Multivariate analysis showed that clinical remission [5.77 (2.03-16.39), p=0.001] was a predictor of good quality of care.
","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Coenen', 'Affiliation': 'Department of Gastroenterology and Hepatology, University Hospitals Leuven, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Haeck', 'Affiliation': 'Department of Gastroenterology and Hepatology, University Hospitals Leuven, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ferrante', 'Affiliation': 'Department of Gastroenterology and Hepatology, University Hospitals Leuven, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Noman', 'Affiliation': 'Department of Gastroenterology and Hepatology, University Hospitals Leuven, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Van Assche', 'Affiliation': 'Department of Gastroenterology and Hepatology, University Hospitals Leuven, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Vermeire', 'Affiliation': 'Department of Gastroenterology and Hepatology, University Hospitals Leuven, KU Leuven, Leuven, Belgium.'}]",Acta gastro-enterologica Belgica,[]
426,31118485,Improving medication adherence in adult kidney transplantation (IMAKT): A pilot randomised controlled trial.,"Resources to support long-term medication adherence in kidney transplantation are limited. This study aimed to determine the efficacy of an intervention designed for kidney transplant recipients to enhance medication adherence. A single-blind, multi-site, 12-month pilot randomised controlled trial was conducted at all five public hospitals providing adult kidney transplantation in Victoria, Australia. Participants were recruited at 4 to 6 weeks post-transplantation. Thirty-five participants were randomly assigned to a 3-month intervention, involving a face-to-face meeting (a medication review and a consumer-centred video) and health coaching every two weeks. Thirty-six were randomised to receive usual care. All participants were followed for nine months post-intervention. There were no differences in adherence between groups measured by Medication Event Monitoring System (MEMS), however, it was underutilised by 42% of participants. Based on the self-reported Basel Assessment of Adherence to Immunosuppressive Medications Scale (BAASIS©) score, the percentage of adherent participants decreased significantly between baseline and 3 to 12 months in the control group (p-values < 0.001) whilst the percentage of adherent participants in the intervention group remained constant over time. No group differences were detected in other outcomes. Due to the complex medication regimen, developing and testing a medication adherence intervention is difficult in kidney transplantation.",2019,"There were no differences in adherence between groups measured by Medication Event Monitoring System (MEMS), however, it was underutilised by 42% of participants.","['five public hospitals providing adult kidney transplantation in Victoria, Australia', 'Thirty-six', 'adult kidney transplantation (IMAKT', 'Thirty-five participants', 'kidney transplant recipients']",[],"['adherence', 'Basel Assessment of Adherence to Immunosuppressive Medications Scale (BAASIS©) score']","[{'cui': 'C0020022', 'cui_str': 'Hospitals, Public'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}, {'cui': 'C0042645', 'cui_str': 'Victoria'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C4319606', 'cui_str': 'Thirty-six'}, {'cui': 'C4319605', 'cui_str': 'Thirty-five'}]",[],"[{'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",35.0,0.0694951,"There were no differences in adherence between groups measured by Medication Event Monitoring System (MEMS), however, it was underutilised by 42% of participants.","[{'ForeName': 'Jac Kee', 'Initials': 'JK', 'LastName': 'Low', 'Affiliation': 'Monash Nursing & Midwifery, Monash University, Clayton, Victoria, Australia. jackee.low@gmail.com.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Manias', 'Affiliation': 'School of Nursing and Midwifery, Centre for Quality and Patient Safety Research, Deakin University, Burwood, Victoria, Australia.'}, {'ForeName': 'Kimberley', 'Initials': 'K', 'LastName': 'Crawford', 'Affiliation': 'Monash Nursing & Midwifery, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Rowan', 'Initials': 'R', 'LastName': 'Walker', 'Affiliation': 'Department of Renal Medicine, Alfred Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Mulley', 'Affiliation': 'Department of Nephrology, Monash Medical Centre, Clayton, Victoria, Australia.'}, {'ForeName': 'Nigel D', 'Initials': 'ND', 'LastName': 'Toussaint', 'Affiliation': 'Department of Nephrology, The Royal Melbourne Hospital, Parkville, Victoria, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Dooley', 'Affiliation': 'Alfred Health, Prahran, Victoria, Australia.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Kennedy', 'Affiliation': 'Department of Nephrology, Monash Medical Centre, Clayton, Victoria, Australia.'}, {'ForeName': 'Catherine L', 'Initials': 'CL', 'LastName': 'Smith', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Nalder', 'Affiliation': 'Pharmacy Department, The Royal Melbourne Hospital, Parkville, Victoria, Australia.'}, {'ForeName': 'Doris', 'Initials': 'D', 'LastName': 'Yip', 'Affiliation': 'Department of Nephrology, The Royal Melbourne Hospital, Parkville, Victoria, Australia.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Williams', 'Affiliation': 'Monash Nursing & Midwifery, Monash University, Clayton, Victoria, Australia.'}]",Scientific reports,['10.1038/s41598-019-44002-y']
427,31127163,"Effects of a moderate-to-high intensity resistance circuit training on fat mass, functional capacity, muscular strength, and quality of life in elderly: A randomized controlled trial.","Physical exercise is considered an important intervention for promoting well-being and healthy aging. The objective was to determine the effects of moderate-to-high intensity resistance circuit training on different parameters of body composition, functional autonomy, muscular strength and quality of life in elderly. A randomized controlled trial was conducted. A total of 45 subjects (27 females, 18 males) aged between 65-75 years old from Murcia (Spain) were divided by sex, and randomly to experimental group (n = 33, mean age 69 ± 3.2 years old) receiving 12 weeks of moderate-to-high intensity resistance circuit training and control group (n = 33, mean age 70 ± 4.1 years old) receiving no exercise intervention. Intra-group comparison, the experimental group showed a significant increment of lean body mass in women and men, which also presented a decrease of fat mass. Both sex presented a significant improve in functional autonomy, and significately higher values of muscular strength. But no changes were observed regarding quality of life in these groups. The control group did not show any differences pre and post-intervention in women, but in men presented an increment of body mass index and total weight post-intervention. No changes were showed in the other variables. Similar results were founded at inter-group comparison. The moderate-to-high intensity resistance circuit training showed increase in total lean body mass, improvements in functional capacity and significantly increase in upper and lower muscular strength in women and men. Progressive resistance circuit training should be promoted for the elderly as it has the potential to improve physical performance, thereby prolonging healthy independent aging.",2019,"The moderate-to-high intensity resistance circuit training showed increase in total lean body mass, improvements in functional capacity and significantly increase in upper and lower muscular strength in women and men.","['elderly', '45 subjects (27 females, 18 males) aged between 65-75 years old from Murcia (Spain) were divided by sex, and randomly to experimental group (n\u2009=\u200933, mean age 69\u2009±\u20093.2 years old) receiving 12 weeks of']","['moderate-to-high intensity resistance circuit training', 'Progressive resistance circuit training', 'moderate-to-high intensity resistance circuit training and control group (n\u2009=\u200933, mean age 70\u2009±\u20094.1 years old) receiving no exercise intervention', 'Physical exercise']","['functional autonomy', 'body composition, functional autonomy, muscular strength and quality of life', 'muscular strength', 'body mass index and total weight post-intervention', 'fat mass', 'fat mass, functional capacity, muscular strength, and quality of life', 'quality of life', 'total lean body mass, improvements in functional capacity', 'lean body mass']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517687', 'cui_str': '3.2'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C2712423', 'cui_str': 'Circuit Training'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517756', 'cui_str': '4.1'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0442025', 'cui_str': 'Muscular (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass (observable entity)'}]",45.0,0.0181237,"The moderate-to-high intensity resistance circuit training showed increase in total lean body mass, improvements in functional capacity and significantly increase in upper and lower muscular strength in women and men.","[{'ForeName': 'Pablo Jorge', 'Initials': 'PJ', 'LastName': 'Marcos-Pardo', 'Affiliation': 'Grupo de Investigación en Salud, Actividad Física, Fitness y Comportamiento Motor (GISAFFCOM), Faculty of Sport, Catholic University San Antonio of Murcia (UCAM), Murcia, Spain. pmarcos@ucam.edu.'}, {'ForeName': 'Francisco Javier', 'Initials': 'FJ', 'LastName': 'Orquin-Castrillón', 'Affiliation': 'Grupo de Investigación en Salud, Actividad Física, Fitness y Comportamiento Motor (GISAFFCOM), Faculty of Sport, Catholic University San Antonio of Murcia (UCAM), Murcia, Spain.'}, {'ForeName': 'Gemma María', 'Initials': 'GM', 'LastName': 'Gea-García', 'Affiliation': 'Grupo de Investigación en Salud, Actividad Física, Fitness y Comportamiento Motor (GISAFFCOM), Faculty of Sport, Catholic University San Antonio of Murcia (UCAM), Murcia, Spain.'}, {'ForeName': 'Ruperto', 'Initials': 'R', 'LastName': 'Menayo-Antúnez', 'Affiliation': 'Grupo de Investigación en Salud, Actividad Física, Fitness y Comportamiento Motor (GISAFFCOM), Faculty of Sport, Catholic University San Antonio of Murcia (UCAM), Murcia, Spain.'}, {'ForeName': 'Noelia', 'Initials': 'N', 'LastName': 'González-Gálvez', 'Affiliation': 'Grupo de Investigación en Salud, Actividad Física, Fitness y Comportamiento Motor (GISAFFCOM), Faculty of Sport, Catholic University San Antonio of Murcia (UCAM), Murcia, Spain.'}, {'ForeName': 'Rodrigo Gomes de Souza', 'Initials': 'RGS', 'LastName': 'Vale', 'Affiliation': 'Grupo de Investigación en Salud, Actividad Física, Fitness y Comportamiento Motor (GISAFFCOM), Faculty of Sport, Catholic University San Antonio of Murcia (UCAM), Murcia, Spain.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Martínez-Rodríguez', 'Affiliation': 'Grupo de Investigación en Salud, Actividad Física, Fitness y Comportamiento Motor (GISAFFCOM), Faculty of Sport, Catholic University San Antonio of Murcia (UCAM), Murcia, Spain.'}]",Scientific reports,['10.1038/s41598-019-44329-6']
428,32240304,Supplementation with Fortified Lipid-Based and Blended Complementary Foods has Variable Impact on Body Composition Among Rural Bangladeshi Children: A Cluster-Randomized Controlled Trial.,"BACKGROUND


Complementary food supplementation enhances linear growth and may affect body composition in children.
OBJECTIVE


We aimed to determine the effect of complementary food supplements provided from the age of 6 to 18 mo on fat-free mass (FFM) and fat mass (FM) gain among children in rural Bangladesh.
METHODS


In an unblinded, cluster-randomized, controlled trial we tested the effects of 4 complementary food supplements for 1 y [chickpea, rice lentil, Plumpy'doz, and wheat-soy-blend++ (WSB++)] compared with no supplements on linear growth. Body composition was estimated using weight-length-based, age- and sex-specific equations at 6, 9, 12, 15, and 18 mo and postintervention aged 24 mo. Generalized estimating equations (GEEs) were applied to estimate the effect of each complementary food on mean FFM and FM from 9 to 18 and 24 mo compared with the control, adjusting for baseline measures. Sex interactions were also explored.
RESULTS


In total, 3592 (65.9% of enrolled) children completed all anthropometric assessments. Estimated FFM and FM (mean ± SD) were 5.3 ± 0.6 kg and 1.4 ± 0.4 kg, respectively, at the age of 6 mo. Mean ± SE FFM and FM from 9 to 18 mo were 75.4 ± 14.0 g and 32.9 ± 7.1 g, and 61.0 ± 16.6 g and 30.0 ± 8.4 g, higher with Plumpy'doz and chickpea foods, respectively, than the control (P < 0.001). Estimated FFM was 41.5 ± 16.6 g higher in rice-lentil-fed versus control (P < 0.05) children. WSB++ had no impact on FFM or FM. A group-sex interaction (P < 0.1) was apparent with Plumpy'doz and rice-lentil foods, with girls involved in the intervention having higher estimated FFM and FM than control girls compared with no significant effect in boys. At 24 mo, FFM and FM remained higher only in girls eating Plumpy'doz compared with the controls (P < 0.01).
CONCLUSIONS


In this randomized trial, supplementation effected small shifts in apparent body composition in rural Bangladeshi children. Where seen, FFM increments were twice that of FM, in proportion to these compartments, and more pronounced in girls. FFM increased in line with reported improvements in length. This trial was registered at clinicaltrials.gov as NCT01562379.",2020,"At 24 mo, FFM and FM remained higher only in girls eating Plumpy'doz compared with the controls (P < 0.01).
","['Rural Bangladeshi Children', 'children', 'rural Bangladeshi children']","['Fortified Lipid-Based and Blended Complementary Foods', ""4 complementary food supplements for 1 y [chickpea, rice lentil, Plumpy'doz, and wheat-soy-blend++ (WSB"", 'WSB']","['FFM or FM', 'Body composition', 'Estimated FFM and FM (mean\xa0±\xa0SD', 'fat-free mass (FFM) and fat mass (FM) gain', 'Mean\xa0±', 'Body Composition', 'length', 'FFM', 'FFM and FM']","[{'cui': 'C0422784', 'cui_str': 'Bangladeshi'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0950052', 'cui_str': 'Chick peas'}, {'cui': 'C0035567', 'cui_str': 'Rice'}, {'cui': 'C0023323', 'cui_str': 'Lentils'}, {'cui': 'C0043137', 'cui_str': 'Wheat'}, {'cui': 'C0037733', 'cui_str': 'Soya bean'}]","[{'cui': 'C0271093', 'cui_str': ""Stargardt's disease""}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C1444754', 'cui_str': 'Length'}]",3592.0,0.190282,"At 24 mo, FFM and FM remained higher only in girls eating Plumpy'doz compared with the controls (P < 0.01).
","[{'ForeName': 'Saijuddin', 'Initials': 'S', 'LastName': 'Shaikh', 'Affiliation': 'The JiVitA Project of Johns Hopkins University, Bangladesh, Gaibandha, Bangladesh.'}, {'ForeName': 'Rebecca K', 'Initials': 'RK', 'LastName': 'Campbell', 'Affiliation': 'Center for Human Nutrition, Department of International Health, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Sucheta', 'Initials': 'S', 'LastName': 'Mehra', 'Affiliation': 'Center for Human Nutrition, Department of International Health, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Alamgir', 'Initials': 'A', 'LastName': 'Kabir', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh, Mohakhali, Dhaka, Bangladesh.'}, {'ForeName': 'Kerry J', 'Initials': 'KJ', 'LastName': 'Schulze', 'Affiliation': 'Center for Human Nutrition, Department of International Health, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Wu', 'Affiliation': 'Center for Human Nutrition, Department of International Health, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Hasmot', 'Initials': 'H', 'LastName': 'Ali', 'Affiliation': 'The JiVitA Project of Johns Hopkins University, Bangladesh, Gaibandha, Bangladesh.'}, {'ForeName': 'Abu Ahmed', 'Initials': 'AA', 'LastName': 'Shamim', 'Affiliation': 'James P Grant School of Public Health, Bangladesh Rural Advancement Committee (BRAC), University, Dhaka, Bangladesh.'}, {'ForeName': 'Keith P', 'Initials': 'KP', 'LastName': 'West', 'Affiliation': 'Center for Human Nutrition, Department of International Health, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Parul', 'Initials': 'P', 'LastName': 'Christian', 'Affiliation': 'Center for Human Nutrition, Department of International Health, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, USA.'}]",The Journal of nutrition,['10.1093/jn/nxaa061']
429,32032641,Birth Control Connect: A randomized trial of an online group to disseminate contraceptive information.,"OBJECTIVE


We sought to test whether participation in an online group including IUD users influenced IUD-related knowledge, attitudes, and behavior among IUD non-users, as a proof-of-concept evaluation of information dissemination for less commonly used or novel contraceptives.
STUDY DESIGN


We conducted a blinded, randomized controlled trial on the effect of online communication with IUD users within an online program called Birth Control Connect. Participants were women age 18-45 living in the United States who had never used an IUD. We invited participants randomized to the intervention to join two-week, nine-member discussion groups including four satisfied IUD users and five IUD non-users; we invited control participants to groups including nine IUD non-users. We performed chi-squared tests on IUD knowledge, information-seeking, informational support and use in immediate post-surveys, and t-tests comparing change in IUD attitudes and frequency of logins to discussion groups.
RESULTS


We invited 488 IUD non-users and enrolled them into 70 groups between October 2015 and April 2016. We found increased positive attitudes towards the IUD in the intervention arm (0.65-point increase between pre- and post-surveys, versus 0.05 mean change for control arm, p = 0.03 for hormonal IUD, with a trend in the same direction for the non-hormonal IUD). Informational support also increased, with 70.3% of intervention arm participants self-reporting that they gained a better idea of what the IUD would be like, compared to 51.3% in control arm (p < 0.01). Of intervention participants, 63.3% versus 51.3% of control participants reported gaining new information from their group (p = 0.03). There were no differences in correct responses to knowledge items or information-seeking between groups.
CONCLUSIONS


Online exposure to IUD users increased positive attitudes toward the IUD and informational support for decision-making about the IUD among non-users.
IMPLICATIONS STATEMENT


Online spaces provide a promising environment for the exchange of accurate, useful contraceptive information based on real user experiences. Interventions aiming to harness social communication through structured online conversations (e.g., on existing social media platforms) about user experiences with lesser-known contraceptive methods such as the IUD may be worthwhile.",2020,"Of intervention participants, 63.3% versus 51.3% of control participants reported gaining new information from their group (p=0.03).","['Participants were women age 18-45 living in the United States who had never used an IUD', '488 IUD non-users and enrolled them into 70 groups between October 2015 and April 2016']",['nine-member discussion groups including four satisfied IUD users and five IUD non-users; we invited control participants to groups including nine IUD non-users'],"['gaining new information', 'correct responses to knowledge items or information-seeking', 'positive attitudes']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}]","[{'cui': 'C0557061', 'cui_str': 'Discussion (procedure)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205455', 'cui_str': '9'}]","[{'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0237428', 'cui_str': 'Optimism'}]",488.0,0.257525,"Of intervention participants, 63.3% versus 51.3% of control participants reported gaining new information from their group (p=0.03).","[{'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Dehlendorf', 'Affiliation': 'University of California, San Francisco, Department of Family & Community Medicine, Person-Centered Reproductive Health Program, 1001 Potrero Ave., San Francisco, CA 94110, USA; University of California, San Francisco, Department of Obstetrics, Gynecology, & Reproductive Sciences, 1001 Potrero Ave., San Francisco, CA 94110, USA; University of California, San Francisco, Department of Epidemiology and Biostatistics, 1001 Potrero Ave., San Francisco, CA 94110, USA. Electronic address: christine.dehlendorf@ucsf.edu.'}, {'ForeName': 'Edith', 'Initials': 'E', 'LastName': 'Fox', 'Affiliation': 'University of California, San Francisco, Department of Family & Community Medicine, Person-Centered Reproductive Health Program, 1001 Potrero Ave., San Francisco, CA 94110, USA. Electronic address: edith.fox@ucsf.edu.'}, {'ForeName': 'Anjana E', 'Initials': 'AE', 'LastName': 'Sharma', 'Affiliation': 'University of California, San Francisco, Department of Family & Community Medicine, Person-Centered Reproductive Health Program, 1001 Potrero Ave., San Francisco, CA 94110, USA. Electronic address: anjana.sharma@ucsf.edu.'}, {'ForeName': 'Jingwen', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'University of Pennsylvania, Annenberg School for Communication, Network Dynamics Group, 3620 Walnut Street, Philadelphia, PA 19104, USA; University of California, Davis, Department of Communication, One Shields Avenue, Davis, CA 95616, USA. Electronic address: jwzzhang@ucdavis.edu.'}, {'ForeName': 'Sijia', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': 'University of Pennsylvania, Annenberg School for Communication, Network Dynamics Group, 3620 Walnut Street, Philadelphia, PA 19104, USA. Electronic address: sijia.yang@asc.penn.edu.'}, {'ForeName': 'Damon', 'Initials': 'D', 'LastName': 'Centola', 'Affiliation': 'University of Pennsylvania, Annenberg School for Communication, Network Dynamics Group, 3620 Walnut Street, Philadelphia, PA 19104, USA. Electronic address: dcentola@asc.penn.edu.'}]",Contraception,['10.1016/j.contraception.2020.01.014']
430,32150651,Pre- and postnatal Lactobacillus reuteri treatment alters DNA methylation of infant T helper cells.,"BACKGROUND


Perinatal childhood exposures, including probiotic supplementation, may affect epigenetic modifications and impact on immune maturation and allergy development. The aim of this study was to assess the effects of pre- and postnatal Lactobacillus reuteri supplementation on DNA methylation in relation to immune maturation and allergy development.
METHODS


DNA methylation patterns were investigated for allergy-related T helper subsets using a locus-specific method and at a genome-wide scale using the Illumina 450K array. From a randomised, double-blind, placebo-controlled allergy prevention trial with pre- and postnatal probiotic supplementation, CD4+ T helper cells were obtained at birth (from cord blood), and 12 and 24 months of age (total (placebo/probiotics); locus-specific method: CB = 32 (17/15), 12 months = 24 (9/15), 24 months = 35 (15/20); Illumina: CB = 19 (10/9), 12 months = 10 (6/4), 24 months = 19(11/8)).
RESULTS


Comparing probiotics to placebo, the greatest genome-wide differential DNA methylation was observed at birth, where the majority of sites were hypomethylated, indicating transcriptional accessibility in the probiotic group. Bioinformatic analyses, including network analyses, revealed a module containing 91 genes, enriched for immune-related pathways such as chemotaxis, PI3K-Akt, MAPK and TGF-β signalling. A majority of the module genes were associated with atopic manifestations (OR = 1.43, P = 2.4 × 10 -6  ), and a classifier built on this model could predict allergy development (AUC = 0.78, P = 3.0 × 10 e-3  ). Pathways such as IFN-γ signalling and T-cell activation were more hypermethylated at birth compared with later in life in both intervention groups over time, in line with DNA methylation patterns in the IFNG locus obtained by the locus-specific methodology.
CONCLUSION


Maternal L. reuteri supplementation during pregnancy alters DNA methylation patterns in CD4+ T cells towards enhanced immune activation at birth, which may affect immune maturation and allergy development.",2020,"Pathways such as IFN-γ signalling and T-cell activation were more hypermethylated at birth compared to later in life in both intervention groups over time, in line with DNA methylation patterns in the IFNG locus obtained by the locus-specific methodology.
",['DNA methylation patterns were investigated for allergy-related T helper subsets using a locus-specific method and at a genome-wide scale using the Illumina 450K array'],"['Maternal L. reuteri supplementation', 'placebo', 'Pre- and postnatal Lactobacillus reuteri treatment', 'pre-and postnatal Lactobacillus reuteri supplementation', 'pre- and postnatal probiotic supplementation, CD4+ T helper cells']","['greatest genome-wide differential DNA methylation', 'DNA methylation of infant T helper cells', 'atopic manifestations']","[{'cui': 'C0376452', 'cui_str': 'DNA Methylation'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C1292732', 'cui_str': 'Investigates'}, {'cui': 'C0002111', 'cui_str': 'Allergy Specialty'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0017428', 'cui_str': 'Genome'}, {'cui': 'C0222045'}]","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0443281', 'cui_str': 'Postnatal (qualifier value)'}, {'cui': 'C0317625', 'cui_str': 'Lactobacillus reuteri'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0018894', 'cui_str': 'T-Lymphocytes, Helper'}]","[{'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0017428', 'cui_str': 'Genome'}, {'cui': 'C0443199', 'cui_str': 'Differential (qualifier value)'}, {'cui': 'C0376452', 'cui_str': 'DNA Methylation'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0018894', 'cui_str': 'T-Lymphocytes, Helper'}, {'cui': 'C0392707', 'cui_str': 'Atopy (disorder)'}]",450.0,0.152078,"Pathways such as IFN-γ signalling and T-cell activation were more hypermethylated at birth compared to later in life in both intervention groups over time, in line with DNA methylation patterns in the IFNG locus obtained by the locus-specific methodology.
","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Forsberg', 'Affiliation': 'Division of Inflammation and Infection, Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Huoman', 'Affiliation': 'Division of Inflammation and Infection, Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Söderholm', 'Affiliation': 'Division of Molecular Medicine and Virology, Department of Biomedical and Clinical Sciences, Wallenberg Centre for Molecular Medicine, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Ratnesh', 'Initials': 'R', 'LastName': 'Bhai Mehta', 'Affiliation': 'Division of Inflammation and Infection, Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Lennart', 'Initials': 'L', 'LastName': 'Nilsson', 'Affiliation': 'Allergy Center, Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Abrahamsson', 'Affiliation': ""Crown Princess Victoria's Child and Youth Hospital, Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden.""}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Ernerudh', 'Affiliation': 'Department of Clinical Immunology and Transfusion Medicine, Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Gustafsson', 'Affiliation': 'Department of Physics, Chemistry and Biology, Bioinformatics, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Maria C', 'Initials': 'MC', 'LastName': 'Jenmalm', 'Affiliation': 'Division of Inflammation and Infection, Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden.'}]",Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology,['10.1111/pai.13240']
431,32236530,Effect of an Intervention in General Practice to Increase the Participation of Immigrants in Cervical Cancer Screening: A Cluster Randomized Clinical Trial.,"Importance


Immigrant women have lower participation in cervical cancer screening (CCS) programs. At the same time, some groups of immigrants have higher prevalence of cervical cancer. Targeted interventions are therefore necessary.
Objective


To determine whether an intervention among general practitioners (GPs) could influence immigrant women's participation in the Norwegian CCS program.
Design, Setting, and Participants


Cluster-randomized clinical trial using the 20 subdistricts of the Bergen, Norway, municipality as clusters. The clusters were matched in 10 pairs according to the number of immigrant women living in them and randomized thereafter. The intervention was implemented between January and June 2017 among urban, primary care, general practices in Bergen. Follow-up ended in January 2018. General practices belonging to the control areas continued treatment as usual. A total of 10 360 women who attended 73 general practices in the 20 subdistricts were included as participants.
Intervention


The intervention consisted of 3 elements: an educational session for GPs at lunch describing the importance of CCS among immigrants and giving advice about how to invite them to participate, a mouse pad as a reminder, and a poster placed in waiting rooms. In the educational session, we elaborated the need for GPs to ask every immigrant woman about CCS, regardless of their reason for contacting their GP.
Main Outcomes and Measures


The main outcome, screening status of immigrant women by January 1, 2018, was obtained from the Norwegian Cancer Registry. The effect of the intervention was measured as odds ratio (OR) for CCS status as of January 1, 2018, for the intervention group vs the control group, with 3 levels of adjustments: baseline CCS status at January 1, 2017 (model 1), additional adjustment for women's age, marital status, income level, and region of origin (model 2), and further adjustment for the GP's sex, age, and region of origin (model 3). Two subgroup analyses, screening status at baseline and women's country of origin, were conducted to assess whether these factors had any influence on the effect of the intervention. Data were analyzed as intention to treat.
Results


A total of 10 360 immigrant women, 5227 (50.4%; mean [SD] age, 44.0 [12.0] years) in the intervention group and 5133 (49.6%; mean [SD] age, 44.5 [11.6] years) in the control group, belonging to 39 general practices in the intervention area and 34 in the control area, were included in the study. The proportion of immigrant women screened increased by 2.6% in the intervention group and 0.6% in the control group. After adjustment for screening status at baseline, women in the intervention group were more likely to have participated in CCS (OR, 1.24 [95% CI, 1.11-1.38]). This statistically significant effect remained unchanged after adjustment for women's characteristics (OR, 1.24 [95% CI, 1.11-1.38]) and was reduced, but still significant, after further adjustment for GP characteristics (OR, 1.19 [95% CI, 1.06-1.34]). In subgroup analyses, the intervention particularly increased participation among women who were not previously screened at baseline (OR, 1.35 [95% CI, 1.16-1.56]), and those from Poland, Pakistan, and Somalia (OR, 1.74 [95% CI, 1.17-2.61]) when adjusting for baseline screening status.
Conclusions and Relevance


Our intervention targeting general practices significantly increased CCS participation among immigrants, although the absolute effect size of 2% in the fully adjusted model was small. Engaging other primary health professionals such as midwives to perform CCS could further contribute to increasing participation.
Trial Registration


ClinicalTrials.gov Identifier: NCT03155581.",2020,The proportion of immigrant women screened increased by 2.6% in the intervention group and 0.6% in the control group.,"['Immigrants in Cervical Cancer Screening', ""women's age, marital status, income level, and region of origin (model 2), and further adjustment for the GP's sex, age, and region of origin (model 3"", ""general practitioners (GPs) could influence immigrant women's participation in the Norwegian CCS program"", 'A total of 10\u202f360 immigrant women, 5227 (50.4%; mean [SD] age, 44.0 [12.0] years) in the intervention group and 5133 (49.6%; mean [SD] age, 44.5 [11.6] years) in the control group, belonging to 39 general practices in the intervention area and 34 in the control area, were included in the study', 'A total of 10\u202f360 women who attended 73 general practices in the 20 subdistricts were included as participants']","['educational session for GPs at lunch describing the importance of CCS among immigrants and giving advice about how to invite them to participate, a mouse pad as a reminder, and a poster placed in waiting rooms']","['odds ratio (OR) for CCS status', 'CCS participation']","[{'cui': 'C0282163', 'cui_str': 'Immigrant'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0024819', 'cui_str': 'Marital status'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0028424', 'cui_str': 'Norwegian language'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4708782', 'cui_str': '11.6'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1456498', 'cui_str': 'Attended'}]","[{'cui': 'C0272302', 'cui_str': 'Gray platelet syndrome'}, {'cui': 'C2697949', 'cui_str': 'Lunch'}, {'cui': 'C0282163', 'cui_str': 'Immigrant'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0332568', 'cui_str': 'Pad'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0442504', 'cui_str': 'Place'}]","[{'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",10360.0,0.132129,The proportion of immigrant women screened increased by 2.6% in the intervention group and 0.6% in the control group.,"[{'ForeName': 'Kathy Ainul', 'Initials': 'KA', 'LastName': 'Møen', 'Affiliation': 'Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Bernadette', 'Initials': 'B', 'LastName': 'Kumar', 'Affiliation': 'Unit for Migration and Health, Norwegian Institute of Public Health (FHI), Oslo, Norway.'}, {'ForeName': 'Jannicke', 'Initials': 'J', 'LastName': 'Igland', 'Affiliation': 'Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Esperanza', 'Initials': 'E', 'LastName': 'Diaz', 'Affiliation': 'Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.1903']
432,32236533,Effect of Intensivist Communication in a Simulated Setting on Interpretation of Prognosis Among Family Members of Patients at High Risk of Intensive Care Unit Admission: A Randomized Trial.,"Importance


Discordance about prognosis between a patient's health care decision-making surrogate and the treating intensivist is common in the intensive care unit (ICU). Empowering families, friends, and caregivers of patients who are critically ill to make informed decisions about care is important, but it is unclear how best to communicate prognostic information to surrogates when a patient is expected to die.
Objective


To determine whether family members, who are often health care decision-making surrogates, interpret intensivists as being more optimistic when questions about prognosis in the ICU are answered indirectly.
Design, Setting, and Participants


This web-based randomized trial was conducted between September 27, 2019, and October 17, 2019, among a national sample of adult children, spouses, partners, or siblings of people with chronic obstructive pulmonary disease who were receiving long-term oxygen therapy. Participants were shown video vignettes depicting an intensivist answering a standardized question about the prognosis of a patient at high risk of death on day 3 of ICU admission. Participants were excluded if they had worked as a physician, nurse, or advanced health care practitioner. Data were analyzed from October 18, 2019, to November 12, 2019.
Interventions


Participants were randomized to view 1 of 4 intensivist communication styles in response to the question ""What do you think is most likely to happen?"": (1) a direct response (control), (2) an indirect response comparing the patient's condition with that of other patients, (3) an indirect response describing the patient's deteriorating physiological condition, or (4) redirection to a discussion of the patient's values and goals.
Main Outcomes and Measures


Participant responses to 2 questions: (1) ""If you had to guess, what do you think the doctor thinks is the chance that your loved one will survive this hospitalization?"" and (2) ""What do you think are the chances that your loved one will survive this hospitalization?"" answered using a 0% to 100% probability scale.
Results


Among 302 participants (median [interquartile range] age, 49 [38-59] years; 204 [68%] women) included in the trial, 165 (55%) were adult children of the individual with chronic obstructive pulmonary disease; 77 participants were randomized to view a direct response, 77 participants were randomized to view an indirect response referencing other patients, 68 participants were randomized to view an indirect response referencing physiological condition, and 80 participants were randomized to view a redirection response. Compared with participants who viewed a direct response, participants who viewed an indirect response referencing other patients (β = 10 [95% CI, 1-19]; P = .03), physiological condition (β = 10 [95% CI, 0-19]; P = .04), or redirection to a discussion of the patient's values and goals (β = 19 [95% CI, 10-28]; P < .001) perceived the intensivist to have a significantly more optimistic prognostic estimate.
Conclusions and Relevance


These findings suggest that family members interpret indirect or redirection responses to questions about prognosis in the ICU setting as more optimistic than direct responses.
Trial Registration


ClinicalTrials.gov Identifier: NCT04239209.",2020,"Compared with participants who viewed a direct response, participants who viewed an indirect response referencing other patients (β = 10 [95% CI, 1-19]; P = .03), physiological condition (β = 10 [95% CI, 0-19]; P = .04), or redirection to a discussion of the patient's values and goals (β = 19 [95% CI, 10-28]; P < .001) perceived the intensivist to have a significantly more optimistic prognostic estimate.
","['Participants were excluded if they had worked as a physician, nurse, or advanced health care practitioner', 'Participants\n\n\nThis web-based randomized trial was conducted between September 27, 2019, and October 17, 2019, among a national sample of adult children, spouses, partners, or siblings of people with chronic obstructive pulmonary disease who were receiving long-term oxygen therapy', 'Family Members of Patients at High Risk of Intensive Care Unit Admission', '302 participants (median [interquartile range] age, 49 [38-59] years; 204 [68%] women) included in the trial, 165 (55%) were adult children of the individual with chronic obstructive pulmonary disease; 77 participants were randomized to view a direct response, 77 participants were randomized to view an indirect response referencing other patients, 68 participants were randomized to view an indirect response referencing physiological condition, and 80 participants']","['Intensivist Communication', ""indirect response describing the patient's deteriorating physiological condition, or (4) redirection to a discussion of the patient's values and goals""]","['optimistic prognostic estimate', 'Main Outcomes and Measures\n\n\nParticipant responses to 2 questions: (1) ']","[{'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0683572', 'cui_str': 'Children, Adult'}, {'cui': 'C0162409', 'cui_str': 'Spouse'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0037047', 'cui_str': 'Sibling'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0418996', 'cui_str': 'Long-term oxygen therapy'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4319555', 'cui_str': '165'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0439852', 'cui_str': 'Indirect'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0439852', 'cui_str': 'Indirect'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]","[{'cui': 'C0564470', 'cui_str': 'Optimistic'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",165.0,0.20929,"Compared with participants who viewed a direct response, participants who viewed an indirect response referencing other patients (β = 10 [95% CI, 1-19]; P = .03), physiological condition (β = 10 [95% CI, 0-19]; P = .04), or redirection to a discussion of the patient's values and goals (β = 19 [95% CI, 10-28]; P < .001) perceived the intensivist to have a significantly more optimistic prognostic estimate.
","[{'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Oppenheim', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Emma M', 'Initials': 'EM', 'LastName': 'Lee', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Scott T', 'Initials': 'ST', 'LastName': 'Vasher', 'Affiliation': 'Department of Internal Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Sandra E', 'Initials': 'SE', 'LastName': 'Zaeh', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Joanna L', 'Initials': 'JL', 'LastName': 'Hart', 'Affiliation': 'Division of Pulmonary, Allergy, and Critical Care Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Alison E', 'Initials': 'AE', 'LastName': 'Turnbull', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.1945']
433,32134713,Effects of resveratrol or estradiol on postexercise endothelial function in estrogen-deficient postmenopausal women.,"Regular exercise enhances endothelial function in older men, but not consistently in estrogen-deficient postmenopausal women. Estradiol treatment improves basal endothelial function and restores improvements in endothelial function (flow-mediated dilation, FMD) to aerobic exercise training in postmenopausal women; however, estradiol treatment is controversial. Resveratrol, an estrogen receptor ligand, enhances exercise training effects on cardiovascular function and nitric oxide (NO) release in animal models, but impairs exercise training effects in men. We conducted a randomized cross-over, double-blinded, placebo-controlled pilot study to determine whether acute (single dose) resveratrol (250-mg tablet) or estradiol (0.05 mg/day transdermal patch) treatment enhances FMD at rest and after a single bout of moderate-intensity aerobic exercise in healthy estrogen-deficient postmenopausal women ( n  = 15, 58.1 ± 3.2 yr). FMD was measured before and after (30, 60, and 120 min) a 40-min bout of moderate-intensity treadmill exercise (60-75% peak heart rate) under the respective conditions (separated by 1-2 wk). FMD was higher ( P  < 0.05) before exercise and at all post-exercise time points in the resveratrol and estradiol conditions compared to placebo. FMD was increased from baseline by 120 min postexercise in the estradiol condition ( P  < 0.001), but not resveratrol or PL conditions. Consistent with our previous findings, estradiol also enhances endothelial function in response to acute endurance exercise. Although resveratrol improved basal FMD, there was no apparent enhancement of FMD to acute exercise and, therefore, may not act as an estradiol mimetic. NEW & NOTEWORTHY  The benefits of endurance exercise training on endothelial function are diminished in estrogen-deficient postmenopausal women, but estradiol treatment appears to restore improvements in endothelial function in this group. We show that basal endothelial function is enhanced with both acute estradiol and resveratrol treatments in estrogen-deficient postmenopausal women, but endothelial function is only enhanced following acute endurance exercise with estradiol treatment.",2020,"FMD was increased from baseline by 120 min post-exercise in the estradiol condition (P<0.001), but not resveratrol or PL conditions.","['postmenopausal women', 'estrogen-deficient postmenopausal women', 'older men', 'men', 'healthy estrogen-deficient postmenopausal women (n=15, 58.1 ± 3.2 yr']","['moderate intensity aerobic exercise', 'aerobic exercise training', 'estradiol', 'placebo', 'Regular exercise', 'resveratrol or estradiol', '40-min bout of moderate-intensity treadmill exercise', 'Estradiol']","['FMD', 'cardiovascular function and nitric oxide (NO) release', 'endothelial function (flow-mediated dilation, FMD', 'basal FMD', 'basal endothelial function', 'endothelial function']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C3537250', 'cui_str': 'ESTROGENS'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4517687', 'cui_str': '3.2'}]","[{'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1700235', 'cui_str': '(11BAPOP2) estradiol'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0582191', 'cui_str': 'Regular exercise (observable entity)'}, {'cui': 'C2930481', 'cui_str': 'cis-Resveratrol'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0007227', 'cui_str': 'Cardiovascular Physiology'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}]",,0.159345,"FMD was increased from baseline by 120 min post-exercise in the estradiol condition (P<0.001), but not resveratrol or PL conditions.","[{'ForeName': 'Cemal', 'Initials': 'C', 'LastName': 'Ozemek', 'Affiliation': 'Department of Medicine, Division of Geriatric Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado.'}, {'ForeName': 'Kerry L', 'Initials': 'KL', 'LastName': 'Hildreth', 'Affiliation': 'Department of Medicine, Division of Geriatric Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Blatchford', 'Affiliation': 'Veterans Affairs Eastern Colorado Geriatric Research, Education and Clinical Center, Denver, Colorado.'}, {'ForeName': 'K Joseph', 'Initials': 'KJ', 'LastName': 'Hurt', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Colorado Anschutz Medical Campus, Aurora, Colorado.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Bok', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Colorado Anschutz Medical Campus, Aurora, Colorado.'}, {'ForeName': 'Douglas R', 'Initials': 'DR', 'LastName': 'Seals', 'Affiliation': 'Department of Integrative Physiology, University of Colorado Boulder, Boulder, Colorado.'}, {'ForeName': 'Wendy M', 'Initials': 'WM', 'LastName': 'Kohrt', 'Affiliation': 'Department of Medicine, Division of Geriatric Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado.'}, {'ForeName': 'Kerrie L', 'Initials': 'KL', 'LastName': 'Moreau', 'Affiliation': 'Department of Medicine, Division of Geriatric Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00488.2019']
434,31574025,Electrosclerotherapy as a Novel Treatment Option for Hypertrophic Capillary Malformations: A Randomized Controlled Pilot Trial.,"BACKGROUND


Bleomycin sclerotherapy is ineffective for treating capillary malformations (CMs) because bleomycin cannot adequately be injected into the small-diameter capillary lumina. Electrosclerotherapy (EST) might be a new treatment modality for CMs, as it combines bleomycin sclerotherapy and ""electroporation""-an electric field applied to the tissue. Electroporation disrupts the transmembrane potential, facilitating bleomycin transportation across the vessel wall, hypothetically leading to targeted drug delivery and increased effectiveness of bleomycin in CMs.
OBJECTIVE


To explore the efficacy, safety, and feasibility of EST for CMs in a randomized within-patient controlled pilot study.
MATERIALS AND METHODS


Fifteen regions of interest (ROI) within the hypertrophic CMs of 5 patients were randomly allocated to EST, bleomycin injection, or no treatment. Outcome was assessed after 7 weeks by the patient and a blinded outcome assessor using the patient-observer scar assessment score (POSAS), global assessment of change (GAC), colorimetry, and laser speckle contrast imaging.
RESULTS


Color and hypertrophy of all ROIs treated with EST significantly improved, based on the POSAS (medians patient -11; observer -13), GAC, and colorimetry (ΔE 3.4-16.5) scores.
CONCLUSION


This pilot study demonstrates the first proof of concept for electrosclerotherapy as a new treatment modality for CMs. Further research is warranted.",2020,"Electroporation disrupts the transmembrane potential, facilitating bleomycin transportation across the vessel wall, hypothetically leading to targeted drug delivery and increased effectiveness of bleomycin in CMs.
","['Fifteen regions of interest (ROI) within the hypertrophic CMs of 5 patients', 'Hypertrophic Capillary Malformations']","['Electrosclerotherapy', 'EST', 'electrosclerotherapy', 'EST, bleomycin injection, or no treatment', 'Electrosclerotherapy (EST', 'Bleomycin sclerotherapy', 'bleomycin', 'bleomycin sclerotherapy']","['efficacy, safety, and feasibility', 'patient-observer scar assessment score (POSAS), global assessment of change (GAC), colorimetry, and laser speckle contrast imaging']","[{'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0020564', 'cui_str': 'Hypertrophy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0340803', 'cui_str': 'Capillary Malformations, Congenital, 1'}]","[{'cui': 'C0600510', 'cui_str': 'ESTs'}, {'cui': 'C4060395', 'cui_str': 'Bleomycin Injection'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0005740', 'cui_str': 'Bleomycin'}, {'cui': 'C0036435', 'cui_str': 'Sclerotherapy'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0008767', 'cui_str': 'Cicatrization'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0009407', 'cui_str': 'Colorimetry'}, {'cui': 'C3854375', 'cui_str': 'Laser speckle contrast imaging'}]",15.0,0.0631886,"Electroporation disrupts the transmembrane potential, facilitating bleomycin transportation across the vessel wall, hypothetically leading to targeted drug delivery and increased effectiveness of bleomycin in CMs.
","[{'ForeName': 'Sophie E R', 'Initials': 'SER', 'LastName': 'Horbach', 'Affiliation': 'Departments of Plastic, Reconstructive and Hand Surgery.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Wolkerstorfer', 'Affiliation': 'Dermatology, and.'}, {'ForeName': 'Folkert', 'Initials': 'F', 'LastName': 'Jolink', 'Affiliation': 'Departments of Plastic, Reconstructive and Hand Surgery.'}, {'ForeName': 'Paul R', 'Initials': 'PR', 'LastName': 'Bloemen', 'Affiliation': 'Biomedical Engineering and Physics, Academic Medical Center (AMC), Amsterdam University Medical Center, University of Amsterdam, the Netherlands.'}, {'ForeName': 'Chantal M A M', 'Initials': 'CMAM', 'LastName': 'van der Horst', 'Affiliation': 'Departments of Plastic, Reconstructive and Hand Surgery.'}]",Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.],['10.1097/DSS.0000000000002191']
435,31597652,Milk and resistance exercise intervention to improve muscle function in community-dwelling older adults at risk of sarcopenia (MIlkMAN): protocol for a pilot study.,"INTRODUCTION


Sarcopenia is a progressive muscle disorder characterised by decline in skeletal muscle mass, strength and function leading to adverse health outcomes, including falls, frailty, poor quality of life and death. It occurs more commonly in older people and can be accelerated by poor diet and low physical activity. Intervention studies incorporating higher dietary protein intakes or protein supplementation combined with resistance exercise (RE) have been shown to limit muscle function decline. However, less is known about the role of whole foods in reducing the risk of sarcopenia. Milk is a source of high-quality nutrients, which may be beneficial for skeletal muscle. This pilot study examines the feasibility and acceptability of milk consumption with RE to improve muscle function in community-dwelling older adults at risk of sarcopenia.
METHODS AND ANALYSIS


30 older adults aged ≥65 years will be randomly allocated to three groups: 'whole milk+RE', 'skimmed milk+RE' or 'control drink+RE'. Assessments will take place in participants' homes, including screening (milk allergies, grip strength, walking speed), baseline and postintervention health and function. All participants will undertake a structured RE intervention twice a week for 6 weeks at a local gym, followed by the consumption of 500 mL of whole or skimmed milk (each ~20 g of protein) or an isocaloric control drink and another 500 mL at home. Participants' views about the study will be assessed using standardised open-ended questions. The primary outcomes include feasibility and acceptability of the intervention with recruitment, retention and intervention response rates. Analyses will include descriptive statistics, exploration of qualitative themes and intervention fidelity.
ETHICS AND DISSEMINATION


Outputs include pilot data to support funding applications; public involvement events; presentation at conferences and peer-reviewed publication.
TRIAL REGISTRATION NUMBER


ISRCTN13398279; Pre-results.",2019,Intervention studies incorporating higher dietary protein intakes or protein supplementation combined with resistance exercise (RE) have been shown to limit muscle function decline.,"['community-dwelling older adults at risk of sarcopenia (MIlkMAN', 'aged ≥65 years', '30 older adults', 'community-dwelling older adults at risk of sarcopenia']","['milk consumption with RE', ""whole milk+RE', 'skimmed milk+RE' or 'control drink+RE"", 'consumption of 500 mL of whole or skimmed milk (each ~20 g of protein) or an isocaloric control drink and another 500 mL at home', 'Milk and resistance exercise intervention', 'protein supplementation combined with resistance exercise (RE']","['screening (milk allergies, grip strength, walking speed), baseline and postintervention health and function', 'feasibility and acceptability of the intervention with recruitment, retention and intervention response rates', 'muscle function']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0872084', 'cui_str': 'Sarcopenias'}, {'cui': 'C0402554', 'cui_str': 'Milkman (occupation)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0349375', 'cui_str': 'Skim milk'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0770246', 'cui_str': 'Protein supplement'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0079840', 'cui_str': 'Milk Allergy'}, {'cui': 'C0429271', 'cui_str': 'Grip strength (observable entity)'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0231484', 'cui_str': 'Muscular activity'}]",500.0,0.0440603,Intervention studies incorporating higher dietary protein intakes or protein supplementation combined with resistance exercise (RE) have been shown to limit muscle function decline.,"[{'ForeName': 'Antoneta', 'Initials': 'A', 'LastName': 'Granic', 'Affiliation': 'AGE Research Group, Institute of Neuroscience, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Hurst', 'Affiliation': 'AGE Research Group, Institute of Neuroscience, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Lorelle', 'Initials': 'L', 'LastName': 'Dismore', 'Affiliation': 'AGE Research Group, Institute of Neuroscience, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Davies', 'Affiliation': 'AGE Research Group, Institute of Neuroscience, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Stevenson', 'Affiliation': 'Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Avan A', 'Initials': 'AA', 'LastName': 'Sayer', 'Affiliation': 'AGE Research Group, Institute of Neuroscience, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Aspray', 'Affiliation': 'NIHR Biomedical Research Centre, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK terry.aspray@newcastle.ac.uk.'}]",BMJ open,['10.1136/bmjopen-2019-031048']
436,31167551,"How does a single session group intervention improve sexual function in ovarian cancer survivors? A secondary analysis of effects of self-efficacy, knowledge and emotional distress.","Although sexual dysfunction after ovarian cancer (OC) treatment is a common side effect, intervention for this issue remains largely unaddressed in the literature. To address this gap, we recently developed and tested a theory-driven psychosexual intervention that successfully improved sexual function in OC survivors. This study is a secondary analysis to determine whether the intervention effects were consistent with our theoretical model. We expected that improved self-efficacy, sexual knowledge and emotional distress would relate to improved sexual function, and that effects of sexual knowledge and self-efficacy on sexual function would be mediated by emotional distress. 46 OC survivors completed study measures prior to and two-months following the intervention. Results indicated that self-efficacy, sexual knowledge, and emotional distress improved significantly post-intervention. While self-efficacy and emotional distress were both directly associated with sexual function; contrary to expectation, change in knowledge was not. Results also demonstrated that the relationship between self-efficacy and sexual function was not mediated by emotional distress. Clinical implications underscore the importance of promoting self-efficacy and decreasing emotional distress in the context of sexual rehabilitation treatment for OC survivors. Next steps include refining the intervention based on these findings and testing in a larger, randomized trial of gynecological cancer survivors.",2020,"Results indicated that self-efficacy, sexual knowledge, and emotional distress improved significantly post-intervention.","['OC survivors', 'ovarian cancer survivors', '46 OC survivors', 'gynecological cancer survivors']",[],"['self-efficacy and sexual function', 'self-efficacy and emotional distress', 'self-efficacy, knowledge and emotional distress', 'self-efficacy, sexual knowledge and emotional distress', 'emotional distress', 'sexual function', 'self-efficacy, sexual knowledge, and emotional distress']","[{'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}]",[],"[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0278092', 'cui_str': 'Sexual function (observable entity)'}, {'cui': 'C0700361', 'cui_str': 'Emotional distress'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",46.0,0.0338941,"Results indicated that self-efficacy, sexual knowledge, and emotional distress improved significantly post-intervention.","[{'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Hungr', 'Affiliation': 'Department of Psychosocial Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Recklitis', 'Affiliation': 'Department of Psychosocial Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Alexi A', 'Initials': 'AA', 'LastName': 'Wright', 'Affiliation': 'Department of Psychosocial Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Sharon L', 'Initials': 'SL', 'LastName': 'Bober', 'Affiliation': 'Department of Psychosocial Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.'}]","Psychology, health & medicine",['10.1080/13548506.2019.1626452']
437,32241670,A Randomized Cross-Over Trial Focused on Clinical Breast Exam Skill Acquisition Using High Fidelity versus Low Fidelity Simulation Models in Rwanda.,"OBJECTIVE


Breast cancer incidence is rising for women in low and middle income country (LMIC)s. Growing the health care workforce trained in clinical breast exam (CBE) is critical to mitigating breast cancer globally. We developed a CBE simulation training course and determined whether training on a low-fidelity (LF) simulation model results in similar skill acquisition as training on high-fidelity (HF) models in Rwanda.
DESIGN


A single-center randomized educational crossover trial was implemented. A preintervention baseline exam (exam 1), followed by a lecture series (exam 2), and training sessions with assigned simulation models was implemented (exam 3)-participants then crossed over to their unassigned model (exam 4). The primary outcome of this study determined mean difference in CBE exam scores between HF and LF groups. Secondary outcomes identified any provider level traits and changes in overall scores.
SETTING


The study was implemented at the University Teaching Hospital, Kigali (CHUK) in Rwanda, Africa from July 2014 to March 2015 PARTICIPANTS: Medical students, residents in surgery, obstetrics and gynecology, and internal medicine residents participated in a 1-day CBE simulation training course.
RESULTS


A total of 107 individuals were analyzed in each arm of the study. Mean difference in exam scores between HF and LF models in exam 1 to 4 was not significantly different (exam 1 0.08 standard error (SE) = 0.47, p = 0.42; exam 2 0.86, SE = 0.69, p = 0.16; exam 3 0.03, SE = 0.38, p = 0.66; exam 4 0.10 SE = 0.37, p = 0.29). Overall exam scores improved from pre- to post-intervention.
CONCLUSIONS


Mean difference in exams scores were not significantly different between participants trained with HF versus LF models. LF models can be utilized as cost effective teaching tools for CBE skill acquisition, in resource poor areas.",2020,"Mean difference in exam scores between HF and LF models in exam 1 to 4 was not significantly different (exam 1 0.08 standard error (SE) = 0.47, p = 0.42; exam 2 0.86, SE = 0.69, p = 0.16; exam 3 0.03, SE = 0.38, p = 0.66;","[' Medical students, residents in surgery, obstetrics and gynecology, and internal medicine residents participated in a', 'Rwanda', 'A total of 107 individuals were analyzed in each arm of the study', 'women in low and middle income country (LMIC)s', 'The study was implemented at the University Teaching Hospital, Kigali (CHUK) in Rwanda, Africa from July 2014 to March 2015 PARTICIPANTS']",['1-day CBE simulation training course'],"['provider level traits and changes in overall scores', 'CBE exam scores', 'Overall exam scores']","[{'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1274104', 'cui_str': 'Obstetrics and gynecology'}, {'cui': 'C0021782', 'cui_str': 'Internal medicine'}, {'cui': 'C0035978', 'cui_str': 'Rwanda'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0001737', 'cui_str': 'Africa'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4042947', 'cui_str': 'Simulation Training'}, {'cui': 'C0750729', 'cui_str': 'Courses'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0582103', 'cui_str': 'Medical assessment'}]",107.0,0.0315952,"Mean difference in exam scores between HF and LF models in exam 1 to 4 was not significantly different (exam 1 0.08 standard error (SE) = 0.47, p = 0.42; exam 2 0.86, SE = 0.69, p = 0.16; exam 3 0.03, SE = 0.38, p = 0.66;","[{'ForeName': 'Shilpa Shree', 'Initials': 'SS', 'LastName': 'Murthy', 'Affiliation': ""Center for Surgery and Public Health, Brigham and Women's Hospital, Boston, Massachusetts; Indiana University, Bloomington, Indiana. Electronic address: shilpamurthy83@gmail.com.""}, {'ForeName': 'Georges', 'Initials': 'G', 'LastName': 'Ntakiyiruta', 'Affiliation': 'University of Rwanda, Department of Surgery, Rwanda.'}, {'ForeName': 'Faustin', 'Initials': 'F', 'LastName': 'Ntirenganya', 'Affiliation': 'University of Rwanda, Department of Surgery, Rwanda.'}, {'ForeName': 'Allen', 'Initials': 'A', 'LastName': 'Ingabire', 'Affiliation': 'University of Rwanda, Department of Surgery, Rwanda.'}, {'ForeName': 'Sara Kikut', 'Initials': 'SK', 'LastName': 'Defregger', 'Affiliation': ""Center for Surgery and Public Health, Brigham and Women's Hospital, Boston, Massachusetts; Indiana University, Bloomington, Indiana; University of Rwanda, Department of Surgery, Rwanda; Massachusetts General Hospital, Boston, Massachusetts; Brigham and Women's Hospital, Dana Farber Cancer Institute, Boston, Massachusetts.""}, {'ForeName': 'Gally', 'Initials': 'G', 'LastName': 'Reznor', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Stu', 'Initials': 'S', 'LastName': 'Lipitz', 'Affiliation': ""Center for Surgery and Public Health, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Susan Lynn', 'Initials': 'SL', 'LastName': 'Troyan', 'Affiliation': ""Brigham and Women's Hospital, Dana Farber Cancer Institute, Boston, Massachusetts.""}, {'ForeName': 'Sughra', 'Initials': 'S', 'LastName': 'Raza', 'Affiliation': ""Brigham and Women's Hospital, Dana Farber Cancer Institute, Boston, Massachusetts.""}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Dunnington', 'Affiliation': 'Indiana University, Bloomington, Indiana.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Riviello', 'Affiliation': ""Center for Surgery and Public Health, Brigham and Women's Hospital, Boston, Massachusetts; University of Rwanda, Department of Surgery, Rwanda.""}]",Journal of surgical education,['10.1016/j.jsurg.2020.02.030']
438,32236732,Effects of ertugliflozin on renal function over 104 weeks of treatment: a post hoc analysis of two randomised controlled trials.,"AIMS/HYPOTHESIS


This study aimed to evaluate the effect of ertugliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, on eGFR and albuminuria (urine albumin/creatinine ratio [UACR]) vs glimepiride or placebo/glimepiride (non-ertugliflozin) over 104 weeks of treatment in participants with type 2 diabetes mellitus, using pooled data from two randomised controlled, active comparator studies from the eValuation of ERTugliflozin effIcacy and Safety (VERTIS) programme (Clinicaltrials.gov NCT01999218 [VERTIS SU] and NCT02033889 [VERTIS MET]). In the VERTIS SU study, ertugliflozin was evaluated vs glimepiride over 104 weeks. In the VERTIS MET study, ertugliflozin was evaluated vs placebo over 26 weeks; eligible participants were switched from placebo to blinded glimepiride from week 26 to week 104. The glycaemic efficacy of ertugliflozin vs non-ertugliflozin was also assessed in the pooled population.
METHODS


Post hoc, exploratory analysis was used to investigate mean changes from baseline in eGFR and UACR over 104 weeks.
RESULTS


Overall, mean (SD) baseline eGFR was 88.2 (18.8) ml min -1  (1.73 m) -2  and geometric mean (95% CI) of baseline UACR was 1.31 mg/mmol (1.23, 1.38). At week 6, the changes in eGFR from baseline were -2.3, -2.7 and -0.7 ml min -1  (1.73 m) -2  for the ertugliflozin 5 mg, ertugliflozin 15 mg and non-ertugliflozin groups, respectively. Mean eGFR in the ertugliflozin groups increased over time thereafter, while it decreased in the non-ertugliflozin group. Week 104 changes in eGFR from baseline were -0.2, 0.1 and -2.0 ml min -1  (1.73 m) -2  for the ertugliflozin 5 mg, ertugliflozin 15 mg and non-ertugliflozin groups, respectively. Among 415 patients (21.4% of the cohort) with albuminuria at baseline, the ertugliflozin groups had greater reductions in UACR at all measured time points up to week 104. At week 104, the non-ertugliflozin-corrected difference in UACR (95% CI) was -29.5% (-44.8, -9.8; p < 0.01) for ertugliflozin 5 mg and -37.6% (-51.8, -19.2; p < 0.001) for ertugliflozin 15 mg. Least squares mean changes from baseline in HbA 1c  (mmol/mol [95% CI]) at week 104 were similar between treatment groups: -6.84 (-7.64, -6.03), -7.74 (-8.54, -6.94) and -6.84 (-7.65, -6.03) in the ertugliflozin 5 mg, ertugliflozin 15 mg and non-ertugliflozin groups, respectively. Least squares mean changes from baseline in HbA1 c  (% [95% CI]) at week 104 were: -0.63 (-0.70, -0.55), -0.71 (-0.78, -0.64) and -0.63 (-0.70, -0.55) in the ertugliflozin 5 mg, ertugliflozin 15 mg and non-ertugliflozin groups, respectively.
CONCLUSIONS/INTERPRETATION


Ertugliflozin reduced eGFR at week 6, consistent with the known pharmacodynamic effects of SGLT2 inhibitors on renal function. Over 104 weeks, eGFR values returned to baseline and were higher with ertugliflozin compared with non-ertugliflozin treatment, even though changes in HbA 1c  did not differ between the groups. Ertugliflozin reduced UACR in patients with baseline albuminuria.
TRIAL REGISTRATION


clinicaltrials.gov NCT01999218 and NCT02033889.",2020,"At week 6, the changes in eGFR from baseline were -2.3, -2.7 and -0.7 ","['participants with type 2 diabetes mellitus', 'patients with baseline albuminuria']","['glimepiride', 'placebo', 'ertugliflozin 15\xa0mg and non-ertugliflozin', 'ertugliflozin vs non-ertugliflozin', 'Ertugliflozin', 'glimepiride or placebo/glimepiride (non-ertugliflozin', 'placebo to blinded glimepiride', 'ertugliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor', 'ertugliflozin']","['UACR', 'glycaemic efficacy', 'ERTugliflozin effIcacy and Safety (VERTIS) programme', 'eGFR and albuminuria (urine albumin/creatinine ratio [UACR', 'Overall, mean (SD) baseline eGFR', 'Mean eGFR', 'eGFR values', 'renal function']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}]","[{'cui': 'C0061323', 'cui_str': 'glimepiride'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4535690', 'cui_str': 'ertugliflozin 15 MG'}, {'cui': 'C4079805', 'cui_str': 'ertugliflozin'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C4079805', 'cui_str': 'ertugliflozin'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0455271', 'cui_str': 'Urine albumin/creatinine ratio measurement'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}]",415.0,0.194555,"At week 6, the changes in eGFR from baseline were -2.3, -2.7 and -0.7 ","[{'ForeName': 'David Z I', 'Initials': 'DZI', 'LastName': 'Cherney', 'Affiliation': 'Division of Nephrology, University of Toronto, Toronto General Hospital, 585 University Ave, 8N-845, Toronto, ON, M5G 2N2, Canada. david.cherney@uhn.ca.'}, {'ForeName': 'Hiddo J L', 'Initials': 'HJL', 'LastName': 'Heerspink', 'Affiliation': 'The George Institute for Global Health, Sydney, NSW, Australia.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Frederich', 'Affiliation': 'Pfizer Inc., Collegeville, PA, USA.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Maldonado', 'Affiliation': 'Merck Sharp & Dohme Limited, London, UK.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Annpey', 'Initials': 'A', 'LastName': 'Pong', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Zhi J', 'Initials': 'ZJ', 'LastName': 'Xu', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Shrita', 'Initials': 'S', 'LastName': 'Patel', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Hickman', 'Affiliation': 'Pfizer Inc., Groton, CT, USA.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Mancuso', 'Affiliation': 'Pfizer Inc., Groton, CT, USA.'}, {'ForeName': 'Ira', 'Initials': 'I', 'LastName': 'Gantz', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Steven G', 'Initials': 'SG', 'LastName': 'Terra', 'Affiliation': 'Pfizer Inc., Andover, MA, USA.'}]",Diabetologia,['10.1007/s00125-020-05133-4']
439,32239460,"The effect of individualized, theory-based counselling intervention on active aging and quality of life among older people (the AGNES intervention study).","BACKGROUND


We define active aging as a striving for activities as per one's goals, capacities and opportunities.
AIM


To test the 1-year counselling intervention effects on active aging.
METHODS


In this two-arm single-blinded randomized controlled trial, the intervention group received individually tailored counselling supporting autonomous motivation for active life (one face-to-face session, four phone calls and supportive written material, n = 101) and the control group written health information (n = 103). Participants were community-dwelling men and women aged 75 or 80 years with intermediate mobility function and without cognitive impairment. The primary outcome was active aging total score measured with the University of Jyväskylä Active Aging Scale (UJACAS, range 0-272, higher values indicate more activity) and secondary outcomes were its subscores for goals, ability, opportunity and activity (range 0-68) and a quality of life (QoL) score. Measures took place at pre-trial, mid-trial (6 months) and post-trial (12 months), except for QoL only pre and post-trial. Data were analyzed with intention-to-treat principles using GEE-models.
RESULTS


The UJACAS total score increased in the intervention group slightly more than in the control group (group by time p-value = 0.050, effect size 0.011, net benefit 2%), but the group effect was not statistically significant. A small effect was observed for the activity subscore (p = 0.007).
DISCUSSION


The individualized counselling supporting autonomous motivation for active life increased the UJACAS score slightly.
CONCLUSIONS


It may be possible to promote active aging with individualized counselling, but the effect is small and it is unclear whether the change is meaningful.",2020,"The UJACAS total score increased in the intervention group slightly more than in the control group (group by time p-value = 0.050, effect size 0.011, net benefit 2%), but the group effect was not statistically significant.","['Participants were community-dwelling men and women aged 75 or 80\xa0years with intermediate mobility function and without cognitive impairment', 'older people (the AGNES intervention study']","['individualized, theory-based counselling intervention', 'individually tailored counselling supporting autonomous motivation for active life (one face-to-face session, four phone calls and supportive written material, n\u2009=\u2009101) and the control group written health information']","['active aging and quality of life', 'active aging total score measured with the University of Jyväskylä Active Aging Scale (UJACAS, range 0-272, higher values indicate more activity) and secondary outcomes were its subscores for goals, ability, opportunity and activity (range 0-68) and a quality of life (QoL) score', 'activity subscore', 'UJACAS total score']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1096775', 'cui_str': 'Intervention Study'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]",,0.166963,"The UJACAS total score increased in the intervention group slightly more than in the control group (group by time p-value = 0.050, effect size 0.011, net benefit 2%), but the group effect was not statistically significant.","[{'ForeName': 'Taina', 'Initials': 'T', 'LastName': 'Rantanen', 'Affiliation': 'Faculty of Sport and Health Sciences, Gerontology Research Center, University of Jyväskylä, Jyväskylä, Finland. taina.rantanen@jyu.fi.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Hassandra', 'Affiliation': 'Faculty of Sport and Health Sciences, Gerontology Research Center, University of Jyväskylä, Jyväskylä, Finland.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Pynnönen', 'Affiliation': 'Faculty of Sport and Health Sciences, Gerontology Research Center, University of Jyväskylä, Jyväskylä, Finland.'}, {'ForeName': 'Sini', 'Initials': 'S', 'LastName': 'Siltanen', 'Affiliation': 'Faculty of Sport and Health Sciences, Gerontology Research Center, University of Jyväskylä, Jyväskylä, Finland.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Kokko', 'Affiliation': 'Faculty of Sport and Health Sciences, Gerontology Research Center, University of Jyväskylä, Jyväskylä, Finland.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Karavirta', 'Affiliation': 'Faculty of Sport and Health Sciences, Gerontology Research Center, University of Jyväskylä, Jyväskylä, Finland.'}, {'ForeName': 'Markku', 'Initials': 'M', 'LastName': 'Kauppinen', 'Affiliation': 'Faculty of Sport and Health Sciences, Gerontology Research Center, University of Jyväskylä, Jyväskylä, Finland.'}, {'ForeName': 'Sarianna', 'Initials': 'S', 'LastName': 'Sipilä', 'Affiliation': 'Faculty of Sport and Health Sciences, Gerontology Research Center, University of Jyväskylä, Jyväskylä, Finland.'}, {'ForeName': 'Milla', 'Initials': 'M', 'LastName': 'Saajanaho', 'Affiliation': 'Faculty of Sport and Health Sciences, Gerontology Research Center, University of Jyväskylä, Jyväskylä, Finland.'}, {'ForeName': 'Erja', 'Initials': 'E', 'LastName': 'Portegijs', 'Affiliation': 'Faculty of Sport and Health Sciences, Gerontology Research Center, University of Jyväskylä, Jyväskylä, Finland.'}]",Aging clinical and experimental research,['10.1007/s40520-020-01535-x']
440,31615919,Effect of Secukinumab on the Different GRAPPA-OMERACT Core Domains in Psoriatic Arthritis: A Pooled Analysis of 2049 Patients.,"OBJECTIVE


To compare the efficacy of secukinumab with that of placebo across the updated Group for Research and Assessment of Psoriasis and Psoriatic Arthritis and Outcome Measures in Rheumatology (GRAPPA-OMERACT) individual psoriatic arthritis (PsA) core domains using pooled data from 4 phase III PsA studies and 1 phase III ankylosing spondylitis (AS) study.
METHODS


Data were pooled from 2049 patients with PsA participating in 4 on-label phase III PsA studies (FUTURE 2-5), and the efficacy of each GRAPPA-OMERACT PsA core domain (musculoskeletal disease activity, skin disease activity, pain, patient's global assessment, physical function, health-related quality of life, fatigue, and systemic inflammation) was assessed using multiple measures and definitions specific to each domain. The MEASURE 2 study, a phase III clinical trial in patients with AS, was used to assess improvement in spine symptoms at Week 16.
RESULTS


Treatment with secukinumab demonstrated robust and consistent efficacy across all GRAPPA-OMERACT PsA core domains, with secukinumab 300 mg showing the greatest response rates across most PsA core domains compared with placebo at Week 16. Notably, among patients treated with secukinumab 300 mg, 34.3% and 19.5% achieved complete resolution of swollen and tender joint counts, respectively; 53.2% and 61.5% achieved complete resolution of enthesitis and dactylitis, respectively; and 33.2% achieved 100% improvement in Psoriasis Area and Severity Index (all p < 0.05 vs placebo); similar improvements were shown for all other core domains.
CONCLUSION


This analysis suggests that secukinumab can benefit people with PsA across the clinical phenotypic spectrum commonly encountered in this disease.",2020,"RESULTS


Treatment with secukinumab demonstrated robust and consistent efficacy across all GRAPPA-OMERACT PsA core domains, with secukinumab 300 mg showing the greatest response rates across most PsA core domains compared with placebo at Week 16.","['Psoriatic Arthritis', '2049 patients with PsA participating in 4 on-label phase 3 PsA studies (FUTURE 2-5', '2049 Patients', '4 phase 3 psoriatic arthritis (PsA) studies and 1 phase 3 ankylosing spondylitis (AS) study']","['placebo', 'Secukinumab', 'secukinumab']","['spine symptoms', 'complete resolution of enthesitis and dactylitis', 'efficacy of each GRAPPA-OMERACT PsA core domain (musculoskeletal disease activity, skin disease activity, pain, patient global assessment, physical function, health-related quality of life, fatigue, and systemic inflammation', 'Psoriasis Area and Severity Index', 'complete resolution of swollen and tender joint counts']","[{'cui': 'C0003872', 'cui_str': 'Psoriatic Arthropathy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0439561', 'cui_str': 'Phase 3 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0038013', 'cui_str': 'Spondylarthritis Ankylopoietica'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3179547', 'cui_str': 'secukinumab'}]","[{'cui': 'C0037949', 'cui_str': 'Spinal Column'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1282952', 'cui_str': 'Enthesitis (disorder)'}, {'cui': 'C0239161', 'cui_str': 'Dactylitis (disorder)'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0026857', 'cui_str': 'Orthopedic Disorders'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0037274', 'cui_str': 'Dermatoses'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0451530', 'cui_str': 'Tender joint count (assessment scale)'}]",2049.0,0.257259,"RESULTS


Treatment with secukinumab demonstrated robust and consistent efficacy across all GRAPPA-OMERACT PsA core domains, with secukinumab 300 mg showing the greatest response rates across most PsA core domains compared with placebo at Week 16.","[{'ForeName': 'Ana-Maria', 'Initials': 'AM', 'LastName': 'Orbai', 'Affiliation': ""From the Johns Hopkins University School of Medicine, Baltimore, Maryland, USA; University of Glasgow, Glasgow; University of Oxford, Oxford, UK; Cleveland Clinic, Cleveland, Ohio, USA; Toronto Western Research Institute and University of Toronto, Toronto, Ontario, Canada; Sorbonne Université, Institut Pierre Louis d'Epidémiologie et de Santé Publique; Pitié Salpêtrière Hospital, AP-HP, Paris, France; Novartis Pharmaceuticals Corporation, East Hanover, New Jersey; Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, Washington, USA. aorbai1@jhmi.edu.""}, {'ForeName': 'Iain B', 'Initials': 'IB', 'LastName': 'McInnes', 'Affiliation': ""From the Johns Hopkins University School of Medicine, Baltimore, Maryland, USA; University of Glasgow, Glasgow; University of Oxford, Oxford, UK; Cleveland Clinic, Cleveland, Ohio, USA; Toronto Western Research Institute and University of Toronto, Toronto, Ontario, Canada; Sorbonne Université, Institut Pierre Louis d'Epidémiologie et de Santé Publique; Pitié Salpêtrière Hospital, AP-HP, Paris, France; Novartis Pharmaceuticals Corporation, East Hanover, New Jersey; Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, Washington, USA.""}, {'ForeName': 'Laura C', 'Initials': 'LC', 'LastName': 'Coates', 'Affiliation': ""From the Johns Hopkins University School of Medicine, Baltimore, Maryland, USA; University of Glasgow, Glasgow; University of Oxford, Oxford, UK; Cleveland Clinic, Cleveland, Ohio, USA; Toronto Western Research Institute and University of Toronto, Toronto, Ontario, Canada; Sorbonne Université, Institut Pierre Louis d'Epidémiologie et de Santé Publique; Pitié Salpêtrière Hospital, AP-HP, Paris, France; Novartis Pharmaceuticals Corporation, East Hanover, New Jersey; Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, Washington, USA.""}, {'ForeName': 'M Elaine', 'Initials': 'ME', 'LastName': 'Husni', 'Affiliation': ""From the Johns Hopkins University School of Medicine, Baltimore, Maryland, USA; University of Glasgow, Glasgow; University of Oxford, Oxford, UK; Cleveland Clinic, Cleveland, Ohio, USA; Toronto Western Research Institute and University of Toronto, Toronto, Ontario, Canada; Sorbonne Université, Institut Pierre Louis d'Epidémiologie et de Santé Publique; Pitié Salpêtrière Hospital, AP-HP, Paris, France; Novartis Pharmaceuticals Corporation, East Hanover, New Jersey; Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, Washington, USA.""}, {'ForeName': 'Dafna D', 'Initials': 'DD', 'LastName': 'Gladman', 'Affiliation': ""From the Johns Hopkins University School of Medicine, Baltimore, Maryland, USA; University of Glasgow, Glasgow; University of Oxford, Oxford, UK; Cleveland Clinic, Cleveland, Ohio, USA; Toronto Western Research Institute and University of Toronto, Toronto, Ontario, Canada; Sorbonne Université, Institut Pierre Louis d'Epidémiologie et de Santé Publique; Pitié Salpêtrière Hospital, AP-HP, Paris, France; Novartis Pharmaceuticals Corporation, East Hanover, New Jersey; Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, Washington, USA.""}, {'ForeName': 'Laure', 'Initials': 'L', 'LastName': 'Gossec', 'Affiliation': ""From the Johns Hopkins University School of Medicine, Baltimore, Maryland, USA; University of Glasgow, Glasgow; University of Oxford, Oxford, UK; Cleveland Clinic, Cleveland, Ohio, USA; Toronto Western Research Institute and University of Toronto, Toronto, Ontario, Canada; Sorbonne Université, Institut Pierre Louis d'Epidémiologie et de Santé Publique; Pitié Salpêtrière Hospital, AP-HP, Paris, France; Novartis Pharmaceuticals Corporation, East Hanover, New Jersey; Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, Washington, USA.""}, {'ForeName': 'Luminita', 'Initials': 'L', 'LastName': 'Pricop', 'Affiliation': ""From the Johns Hopkins University School of Medicine, Baltimore, Maryland, USA; University of Glasgow, Glasgow; University of Oxford, Oxford, UK; Cleveland Clinic, Cleveland, Ohio, USA; Toronto Western Research Institute and University of Toronto, Toronto, Ontario, Canada; Sorbonne Université, Institut Pierre Louis d'Epidémiologie et de Santé Publique; Pitié Salpêtrière Hospital, AP-HP, Paris, France; Novartis Pharmaceuticals Corporation, East Hanover, New Jersey; Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, Washington, USA.""}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Chambenoit', 'Affiliation': ""From the Johns Hopkins University School of Medicine, Baltimore, Maryland, USA; University of Glasgow, Glasgow; University of Oxford, Oxford, UK; Cleveland Clinic, Cleveland, Ohio, USA; Toronto Western Research Institute and University of Toronto, Toronto, Ontario, Canada; Sorbonne Université, Institut Pierre Louis d'Epidémiologie et de Santé Publique; Pitié Salpêtrière Hospital, AP-HP, Paris, France; Novartis Pharmaceuticals Corporation, East Hanover, New Jersey; Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, Washington, USA.""}, {'ForeName': 'Xiangyi', 'Initials': 'X', 'LastName': 'Meng', 'Affiliation': ""From the Johns Hopkins University School of Medicine, Baltimore, Maryland, USA; University of Glasgow, Glasgow; University of Oxford, Oxford, UK; Cleveland Clinic, Cleveland, Ohio, USA; Toronto Western Research Institute and University of Toronto, Toronto, Ontario, Canada; Sorbonne Université, Institut Pierre Louis d'Epidémiologie et de Santé Publique; Pitié Salpêtrière Hospital, AP-HP, Paris, France; Novartis Pharmaceuticals Corporation, East Hanover, New Jersey; Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, Washington, USA.""}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Mease', 'Affiliation': ""From the Johns Hopkins University School of Medicine, Baltimore, Maryland, USA; University of Glasgow, Glasgow; University of Oxford, Oxford, UK; Cleveland Clinic, Cleveland, Ohio, USA; Toronto Western Research Institute and University of Toronto, Toronto, Ontario, Canada; Sorbonne Université, Institut Pierre Louis d'Epidémiologie et de Santé Publique; Pitié Salpêtrière Hospital, AP-HP, Paris, France; Novartis Pharmaceuticals Corporation, East Hanover, New Jersey; Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, Washington, USA.""}]",The Journal of rheumatology,['10.3899/jrheum.190507']
441,32229801,Efficacy and Safety of Etomidate in Comparison with Propofol or Midazolam as Sedative for Upper Gastrointestinal Endoscopy.,"BACKGROUND/AIMS


In this study, we compared the efficacy and safety of etomidate with those of propofol or midazolam for the maintenance of sedation during endoscopy.
METHODS


The study enrolled patients who underwent sedative endoscopy in our hospital and divided them into three groups. Patients in each group were administered midazolam as induction therapy and were subsequently administered either midazolam (M + M group), propofol (M + P group), or etomidate (M + E group) as maintenance medication. The primary outcome was overall cardiovascular and respiratory adverse events.
RESULTS


In total, 105 patients who underwent sedative endoscopic examination were enrolled. The outcomes related to the procedure and sedation were not significantly different among the groups. Overall cardiovascular and respiratory adverse events were observed in 9 patients (25.7%) in the M + M group, 8 patients (23.5%) in the M + P group, and 10 patients (27.8%) in the M + E group. The logistic regression analysis revealed that etomidate use was not an independent risk factor for overall cardiovascular and respiratory adverse events.
CONCLUSION


The outcomes following the use of etomidate for maintenance after induction with midazolam for sedation in upper gastrointestinal endoscopy were not inferior to those following midazolam or propofol use from the perspectives of safety and efficacy.",2020,"The logistic regression analysis revealed that etomidate use was not an independent risk factor for overall cardiovascular and respiratory adverse events.
","['105 patients who underwent sedative endoscopic examination were enrolled', 'Upper Gastrointestinal Endoscopy']","['midazolam or propofol', 'Propofol or Midazolam', 'Etomidate', 'midazolam', 'midazolam (M + M group), propofol (M + P group), or etomidate (M + E group) as maintenance medication', 'etomidate', 'sedative endoscopy', 'propofol or midazolam']","['Efficacy and Safety', 'procedure and sedation', 'efficacy and safety', 'overall cardiovascular and respiratory adverse events', 'safety and efficacy', 'Overall cardiovascular and respiratory adverse events']","[{'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036557', 'cui_str': 'Sedatives'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C0079304', 'cui_str': 'Esophagogastroduodenoscopy'}]","[{'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0015131', 'cui_str': 'Etomidate'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0036557', 'cui_str': 'Sedatives'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",105.0,0.0384774,"The logistic regression analysis revealed that etomidate use was not an independent risk factor for overall cardiovascular and respiratory adverse events.
","[{'ForeName': 'Jae Hyun', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Kosin University College of Medicine, Busan, Korea.'}, {'ForeName': 'Sanghwan', 'Initials': 'S', 'LastName': 'Byun', 'Affiliation': 'Department of Internal Medicine, Kosin University College of Medicine, Busan, Korea.'}, {'ForeName': 'Youn Jung', 'Initials': 'YJ', 'LastName': 'Choi', 'Affiliation': 'Department of Internal Medicine, Kosin University College of Medicine, Busan, Korea.'}, {'ForeName': 'Hye Jung', 'Initials': 'HJ', 'LastName': 'Kwon', 'Affiliation': 'Department of Internal Medicine, Kosin University College of Medicine, Busan, Korea.'}, {'ForeName': 'Kyoungwon', 'Initials': 'K', 'LastName': 'Jung', 'Affiliation': 'Department of Internal Medicine, Kosin University College of Medicine, Busan, Korea.'}, {'ForeName': 'Sung Eun', 'Initials': 'SE', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Kosin University College of Medicine, Busan, Korea.'}, {'ForeName': 'Moo In', 'Initials': 'MI', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Kosin University College of Medicine, Busan, Korea.'}, {'ForeName': 'Won', 'Initials': 'W', 'LastName': 'Moon', 'Affiliation': 'Department of Internal Medicine, Kosin University College of Medicine, Busan, Korea.'}, {'ForeName': 'Seun Ja', 'Initials': 'SJ', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Kosin University College of Medicine, Busan, Korea.'}]",Clinical endoscopy,['10.5946/ce.2019.210']
442,31228534,Toward Understanding the Relationship Between Prioritized Values and Preferences for Cardiopulmonary Resuscitation Among Seriously Ill Adults.,"CONTEXT


Prioritizing among potentially conflicting end-of-life values may help patients discriminate among treatments and allow clinicians to align treatments with values.
OBJECTIVES


To investigate end-of-life values that patients prioritize when facing explicit trade-offs and identify predictors of patients whose values and treatment preferences seem inconsistent.
METHODS


Analysis of surveys from a multi-center cluster-randomized trial of patients with serious illness. Respondents prioritized end-of-life values and identified cardiopulmonary resuscitation (CPR) preferences in two health states.
RESULTS


Of 535 patients, 60% prioritized relief of discomfort over extending life, 17% prioritized extending life over relief of discomfort, and 23% were unsure. Patients prioritizing extending life were most likely to prefer CPR, with 93% preferring CPR in current health and 67% preferring CPR if dependent on others, compared with 69% and 21%, respectively, for patients prioritizing relief of discomfort, and 78% and 33%, respectively, for patients unsure of their prioritized value (P < 0.001 for all comparisons). Among patients prioritizing relief of discomfort, preference for CPR in current health was less likely among older patients (odds ratio 0.958 per year; 95% CI 0.935, 0.981) and more likely with better self-perceived health (odds ratio 1.402 per level of health; 95% CI 1.090, 1.804).
CONCLUSION


Clinicians face challenges as they clarify patient values and align treatments with values. Patients' values predicted CPR preferences, but a substantial proportion of patients expressed CPR preferences that appeared potentially inconsistent with their primary value. Clinicians should question assumptions about relationships between values and CPR preferences. Further research is needed to identify ways to use values to guide treatment decisions.",2019,"Patients prioritizing extending life were most likely to prefer CPR, with 93% preferring CPR in current health and 67% preferring CPR if dependent on others, compared to 69% and 21% respectively for patients prioritizing relief of discomfort, and 78% and 33% respectively for patients unsure of their prioritized value (p<0.001 for all comparisons).","['Analysis of surveys from a multi-center cluster-randomized trial of patients with serious illness', 'Seriously Ill Adults']",['Cardiopulmonary Resuscitation'],"['prioritizing relief of discomfort', 'prioritized relief of discomfort over extending life']","[{'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0007203', 'cui_str': 'Cardio-Pulmonary Resuscitation'}]","[{'cui': 'C1301676', 'cui_str': 'Relieves (qualifier value)'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C0231449', 'cui_str': 'Extended (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}]",535.0,0.0483671,"Patients prioritizing extending life were most likely to prefer CPR, with 93% preferring CPR in current health and 67% preferring CPR if dependent on others, compared to 69% and 21% respectively for patients prioritizing relief of discomfort, and 78% and 33% respectively for patients unsure of their prioritized value (p<0.001 for all comparisons).","[{'ForeName': 'Matthew E', 'Initials': 'ME', 'LastName': 'Modes', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, University of Washington, Seattle, Washington, USA; Cambia Palliative Care Center of Excellence, University of Washington, Seattle, Washington, USA. Electronic address: modes@uw.edu.'}, {'ForeName': 'Ruth A', 'Initials': 'RA', 'LastName': 'Engelberg', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, University of Washington, Seattle, Washington, USA; Cambia Palliative Care Center of Excellence, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Lois', 'Initials': 'L', 'LastName': 'Downey', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, University of Washington, Seattle, Washington, USA; Cambia Palliative Care Center of Excellence, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Nielsen', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, University of Washington, Seattle, Washington, USA; Cambia Palliative Care Center of Excellence, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Robert Y', 'Initials': 'RY', 'LastName': 'Lee', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, University of Washington, Seattle, Washington, USA; Cambia Palliative Care Center of Excellence, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'J Randall', 'Initials': 'JR', 'LastName': 'Curtis', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, University of Washington, Seattle, Washington, USA; Cambia Palliative Care Center of Excellence, University of Washington, Seattle, Washington, USA; Department of Bioethics and Humanities, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Erin K', 'Initials': 'EK', 'LastName': 'Kross', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, University of Washington, Seattle, Washington, USA; Cambia Palliative Care Center of Excellence, University of Washington, Seattle, Washington, USA.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2019.06.011']
443,31493956,Oxytocin-Augmented and Non-Sedating High-Intensity-Focused Ultrasound (HIFU) for Uterine Fibroids Showed Promising Outcome As Compared To HIFU Alone or Uterine Artery Embolization.,"The use of a modified energy transmission protocol and oxytocin augmentation is being proposed as a high-intensity-focused ultrasound (HIFU) treatment for uterine fibroids, to aim for an effective and well-tolerable treatment to be given as an out-patient procedure without anesthesia or sedation. The objective of this study was to evaluate the safety and treatment effectiveness of this new protocol. The treatment outcomes of 9 consecutive patients (study group) were compared with those of 51 patients (control group) who had been randomized (1:1) to receive HIFU (n = 24) or uterine artery embolization ([UAE] n = 27). There was no major adverse event. At 3 mo, the median proportion of fibroid volume compared with the baseline was 51.1% in the study group, significantly smaller than that in the control groups (HIFU 76.6%, UAE 66.2%). At 6 mo, all patients in the study group became symptom free (9/9, 100%), a result significantly better than that of both control groups. The proportion of patients with good quality of life was significantly higher in the study group (5/7, 71.4%) compared with the control groups (HIFU 3/24, 12.5%; UAE 7/27, 25.9%). Within 24 mo, none of the patients in the study HIFU group required re-intervention, a result significantly better than that in the control HIFU group (15/24, 62.5%). The treatment could result in a very promising long-term imaging and clinical outcome that may be better than those of UAE; however, a randomized control trial of larger scale is required for further evaluation of this treatment.",2019,"The proportion of patients with good quality of life was significantly higher in the study group (5/7, 71.4%) compared with the control groups (HIFU 3/24, 12.5%; UAE 7/27, 25.9%).","['Uterine Fibroids', '9 consecutive patients (study group) were compared with those of 51 patients (control group) who had been randomized (1:1) to receive']","['HIFU', 'uterine artery embolization ([UAE', 'oxytocin augmentation', 'Oxytocin-Augmented and Non-Sedating High-Intensity-Focused Ultrasound ']","['median proportion of fibroid volume', 'proportion of patients with good quality of life', 'symptom free']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0729536', 'cui_str': 'Uterine Artery Embolization'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C1293122', 'cui_str': 'Augmentation procedure'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0441583', 'cui_str': 'High intensity focused ultrasound (qualifier value)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0042133', 'cui_str': 'Fibroid Uterus'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0353338,"The proportion of patients with good quality of life was significantly higher in the study group (5/7, 71.4%) compared with the control groups (HIFU 3/24, 12.5%; UAE 7/27, 25.9%).","[{'ForeName': 'Simon Chun-Ho', 'Initials': 'SC', 'LastName': 'Yu', 'Affiliation': 'Department of Imaging and Interventional Radiology, The Chinese University of Hong Kong, Hong Kong SAR; Vascular and Interventional Radiology Clinical Science Center, The Chinese University of Hong Kong, Hong Kong SAR. Electronic address: simonyu@cuhk.edu.hk.'}, {'ForeName': 'Eva Chun-Wai', 'Initials': 'EC', 'LastName': 'Cheung', 'Affiliation': 'Department of Obstetrics and Gynecology, The Chinese University of Hong Kong, Hong Kong SAR.'}, {'ForeName': 'Vivian Yee-Fong', 'Initials': 'VY', 'LastName': 'Leung', 'Affiliation': 'Department of Imaging and Interventional Radiology, The Chinese University of Hong Kong, Hong Kong SAR.'}, {'ForeName': 'Linda Wen-Ying', 'Initials': 'LW', 'LastName': 'Fung', 'Affiliation': 'Department of Obstetrics and Gynecology, The Chinese University of Hong Kong, Hong Kong SAR.'}]",Ultrasound in medicine & biology,['10.1016/j.ultrasmedbio.2019.07.410']
444,31615795,"Study protocol for VIdeo assisted thoracoscopic lobectomy versus conventional Open LobEcTomy for lung cancer, a UK multicentre randomised controlled trial with an internal pilot (the VIOLET study).","INTRODUCTION


Lung cancer is a leading cause of cancer deaths worldwide and surgery remains the main treatment for early stage disease. Prior to the introduction of video-assisted thoracoscopic surgery (VATS), lung resection for cancer was undertaken through an open thoracotomy. To date, the evidence base supporting the different surgical approaches is based on non-randomised studies, small randomised trials and is focused mainly on short-term in-hospital outcomes.
METHODS AND ANALYSIS


The VIdeo assisted thoracoscopic lobectomy versus conventional Open LobEcTomy for lung cancer study is a UK multicentre parallel group randomised controlled trial (RCT) with blinding of outcome assessors and participants (to hospital discharge) comparing the effectiveness, cost-effectiveness and acceptability of VATS lobectomy versus open lobectomy for treatment of lung cancer. We will test the hypothesis that VATS lobectomy is superior to open lobectomy with respect to self-reported physical function 5 weeks after randomisation (approximately 1 month after surgery). Secondary outcomes include assessment of efficacy (hospital stay, pain, proportion and time to uptake of chemotherapy), measures of safety (adverse health events), oncological outcomes (proportion of patients upstaged to pathologic N2 (pN2) disease and disease-free survival), overall survival and health related quality of life to 1 year. The QuinteT Recruitment Intervention is integrated into the trial to optimise recruitment.
ETHICS AND DISSEMINATION


This trial has been approved by the UK (Dulwich) National Research Ethics Service Committee London. Findings will be written-up as methodology papers for conference presentation, and publication in peer-reviewed journals. Many aspects of the feasibility work will inform surgical RCTs in general and these will be reported at methodology meetings. We will also link with lung cancer clinical studies groups. The patient and public involvement group that works with the Respiratory Biomedical Research Unit at the Brompton Hospital will help identify how we can best publicise the findings.
TRIAL REGISTRATION NUMBER


ISRCTN13472721.",2019,"METHODS AND ANALYSIS


The VIdeo assisted thoracoscopic lobectomy versus conventional Open LobEcTomy for lung cancer study is a UK multicentre parallel group randomised controlled trial (RCT) with blinding of outcome assessors and participants (to hospital discharge) comparing the effectiveness, cost-effectiveness and acceptability of VATS lobectomy versus open lobectomy for treatment of lung cancer.","['lung cancer', 'UK (Dulwich']","['VATS lobectomy versus open lobectomy', 'VATS lobectomy', 'VIdeo assisted thoracoscopic lobectomy versus conventional Open LobEcTomy', 'video-assisted thoracoscopic surgery (VATS), lung resection']","['assessment of efficacy (hospital stay, pain, proportion and time to uptake of chemotherapy), measures of safety (adverse health events), oncological outcomes (proportion of patients upstaged to pathologic N2 (pN2) disease and disease-free survival), overall survival and health related quality of life to 1\u2009year', 'effectiveness, cost-effectiveness and acceptability']","[{'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}]","[{'cui': 'C0405532', 'cui_str': 'Lobectomy of thyroid gland (procedure)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0752151', 'cui_str': 'VATS'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}]","[{'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",,0.169653,"METHODS AND ANALYSIS


The VIdeo assisted thoracoscopic lobectomy versus conventional Open LobEcTomy for lung cancer study is a UK multicentre parallel group randomised controlled trial (RCT) with blinding of outcome assessors and participants (to hospital discharge) comparing the effectiveness, cost-effectiveness and acceptability of VATS lobectomy versus open lobectomy for treatment of lung cancer.","[{'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Lim', 'Affiliation': 'Academic Division of Thoracic Surgery, The Royal Brompton and Harefield NHS foundation Trust, London, UK e.lim@rbht.nhs.uk.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Batchelor', 'Affiliation': 'Thoracic Surgery, Bristol Royal Infirmary, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Shackcloth', 'Affiliation': 'Department of Thoracic Surgery, Liverpool Heart and Chest Hospital, Liverpool, UK.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Dunning', 'Affiliation': 'Department of Thoracic Surgery, The James Cook University Hospital, Middlesbrough, UK.'}, {'ForeName': 'Niall', 'Initials': 'N', 'LastName': 'McGonigle', 'Affiliation': 'Department of Thoracic Surgery, Royal Brompton and Harefield, Harefield Hospital, London, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Brush', 'Affiliation': 'Clinical Trials and Evaluation Unit, Bristol Trials Centre, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Dabner', 'Affiliation': 'Clinical Trials and Evaluation Unit, Bristol Trials Centre, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Rosie', 'Initials': 'R', 'LastName': 'Harris', 'Affiliation': 'Clinical Trials and Evaluation Unit, Bristol Trials Centre, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Holly E', 'Initials': 'HE', 'LastName': 'Mckeon', 'Affiliation': 'Clinical Trials and Evaluation Unit, Bristol Trials Centre, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Sangeetha', 'Initials': 'S', 'LastName': 'Paramasivan', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Daisy', 'Initials': 'D', 'LastName': 'Elliott', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Stokes', 'Affiliation': 'Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Wordsworth', 'Affiliation': 'Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Blazeby', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Chris A', 'Initials': 'CA', 'LastName': 'Rogers', 'Affiliation': 'Clinical Trials and Evaluation Unit, Bristol Trials Centre, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-029507']
445,31615800,Protocol for a multicentre randomised controlled trial evaluating the effects of moderate hypothermia versus normothermia on mortality in patients with refractory cardiogenic shock rescued by venoarterial extracorporeal membrane oxygenation (VA-ECMO) (HYPO-ECMO study).,"INTRODUCTION


Venoarterial extracorporeal membrane oxygenation (VA-ECMO) is widely used to support the most severe forms of cardiogenic shock (CS). Nevertheless, despite extracorporeal membrane oxygenation (ECMO) use, mortality still remains high (50%). Moderate hypothermia (MH) (33°C-34°C) may improve cardiac performance and decrease ischaemia-reperfusion injuries. The use of MH during VA-ECMO is strongly supported by experimental and preliminary clinical data.
METHODS AND ANALYSIS


The Hypothermia-Extracorporeal Membrane Oxygenation (HYPO-ECMO) study is a multicentre, prospective, controlled randomised trial between an MH group (33°C≤T°C≤34°C) and normothermia group (36°C≤T°C≤37°C). The primary endpoint is all-cause mortality at day 30 following randomisation. The study will also assess as secondary endpoints the effects of targeted temperature management strategies on (1) mortality rate at different time points, (2) organ failure and supportive treatment use and (3) safety. All intubated adults with refractory CS supported with VA-ECMO will be screened. Exclusion criteria are patients having undergone cardiac surgery for heart transplantation or left or biventricular assist device implantation, acute poisoning with cardiotoxic drugs, pregnancy, uncontrolled bleeding and refractory cardiac arrest.Three-hundred and thirty-four patients will be randomised and followed up to 6 months to detect a 15% difference in mortality. Data analysis will be intention to treat. The differences between the two study groups in the risk of all-cause mortality at day 30 following randomisation will be studied using logistic regression analysis adjusted for postcardiotomy setting, prior cardiac arrest, prior myocardial infarction, age, vasopressor dose, Sepsis-related Organ Failure Assessment (SOFA) score and lactate at randomisation.
ETHICS AND DISSEMINATION


Ethics approval has been granted by the Comité de Protection des Personnes Est III Ethics Committee. The trial has been approved by the French Health Authorities (Agence Nationale de la Sécurité du Médicament et des Produits de Santé). Dissemination of results will be performed via journal articles and presentations at national and international conferences. Since this study is also the first step in the constitution of an 'ECMO Trials Group', its results will also be disseminated by the aforementioned group.
TRIAL REGISTRATION NUMBER


NCT02754193.",2019,"The differences between the two study groups in the risk of all-cause mortality at day 30 following randomisation will be studied using logistic regression analysis adjusted for postcardiotomy setting, prior cardiac arrest, prior myocardial infarction, age, vasopressor dose, Sepsis-related Organ Failure Assessment (SOFA) score and lactate at randomisation.
","['patients with refractory cardiogenic shock rescued by venoarterial extracorporeal membrane oxygenation (VA-ECMO) (HYPO-ECMO study', 'MH group (33°C≤T°C≤34°C) and normothermia group (36°C≤T°C≤37°C', 'All intubated adults with refractory CS', 'patients having undergone cardiac surgery for heart transplantation or left or biventricular assist device implantation, acute poisoning with cardiotoxic drugs, pregnancy, uncontrolled bleeding and refractory cardiac arrest']","['moderate hypothermia versus normothermia', 'Hypothermia-Extracorporeal Membrane Oxygenation (HYPO-ECMO', 'Venoarterial extracorporeal membrane oxygenation (VA-ECMO']","['mortality', 'Moderate hypothermia (MH', 'cardiac performance', 'postcardiotomy setting, prior cardiac arrest, prior myocardial infarction, age, vasopressor dose, Sepsis-related Organ Failure Assessment (SOFA) score and lactate at randomisation', 'cause mortality', 'risk of all-cause mortality', 'mortality rate at different time points, (2) organ failure and supportive treatment use and (3) safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0036980', 'cui_str': 'Shock, Cardiogenic'}, {'cui': 'C0450124', 'cui_str': 'Venoarterial (qualifier value)'}, {'cui': 'C0015357', 'cui_str': 'ECLS Treatment'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0445103', 'cui_str': 'Normothermia (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0018823', 'cui_str': 'Transplantation, Cardiac'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0179322', 'cui_str': 'Biventricular assist device'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0032343', 'cui_str': 'Poisoning'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0018790', 'cui_str': 'Cardiac Arrest'}]","[{'cui': 'C0445045', 'cui_str': 'Moderate hypothermia (qualifier value)'}, {'cui': 'C0445103', 'cui_str': 'Normothermia (qualifier value)'}, {'cui': 'C0413252', 'cui_str': 'Hypothermia due to exposure'}, {'cui': 'C0015357', 'cui_str': 'ECLS Treatment'}, {'cui': 'C0450124', 'cui_str': 'Venoarterial (qualifier value)'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0445045', 'cui_str': 'Moderate hypothermia (qualifier value)'}, {'cui': 'C0018790', 'cui_str': 'Cardiac Arrest'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0349410', 'cui_str': 'Single organ dysfunction (disorder)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",30.0,0.268528,"The differences between the two study groups in the risk of all-cause mortality at day 30 following randomisation will be studied using logistic regression analysis adjusted for postcardiotomy setting, prior cardiac arrest, prior myocardial infarction, age, vasopressor dose, Sepsis-related Organ Failure Assessment (SOFA) score and lactate at randomisation.
","[{'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Jacquot', 'Affiliation': 'Medical Intensive Care Unit, Institut Lorrain du Coeur et des Vaisseaux, CHRU Nancy-Hôpitaux de Brabois, Vandoeuvre-lès-Nancy, Nancy, France.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Lepage', 'Affiliation': ""Centre d'Investigation Clinique 1433, module Plurithématique, Institut Lorrain du Coeur et des Vaisseaux Louis Mathieu, CHRU Nancy - Hopitaux de Brabois, Vandoeuvre-lès-Nancy, France.""}, {'ForeName': 'Ludovic', 'Initials': 'L', 'LastName': 'Merckle', 'Affiliation': ""Centre d'Investigation Clinique 1433, module Plurithématique, Institut Lorrain du Coeur et des Vaisseaux Louis Mathieu, CHRU Nancy - Hopitaux de Brabois, Vandoeuvre-lès-Nancy, France.""}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Girerd', 'Affiliation': ""INSERM, Centre d'Investigation Clinique 1433, Université de Lorraine, CHRU de Nancy, Institut Lorrain du Coeur et des Vaisseaux, Hôpitaux de Brabois, Vandoeuvre-lès-Nancy, France, Inserm 1116 and INI-CRCT (Cardiovascular and Renal Clinical Trialists) F-CRIN Network, Vandoeuvre les Nancy, France.""}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Levy', 'Affiliation': 'Groupe Choc, équipe 2, Inserm U1116, Vandoeuvre les Nancy, France b.levy@chru-nancy.fr.'}]",BMJ open,['10.1136/bmjopen-2019-031697']
446,31615803,Process-evaluation and outcome-evaluation of a training programme for healthcare professionals in oncology to enhance their competencies in caring for patients with minor children: a study protocol for a randomised controlled pilot study.,"INTRODUCTION


Patients with cancer having minor children experience particular burden and strains. Being patient and parent at the same time is associated with specific needs of support. Therefore, the communication of child-related and family-related issues plays an important role in patient care. This study aims at testing the feasibility of a training to improve the situation of patients with cancer having minor children and their families by enhancing the competencies of healthcare professionals (HCPs, eg, physicians, nurses, psychologists) in caring for patients with cancer having minor children. Moreover, the study aims at testing the study design and outcomes of the evaluation concept and preliminary effects of the training.
METHODS AND ANALYSIS


We will conduct a randomised controlled pilot trial with three arms (face-to-face training versus web-based training versus waitlist control group) to investigate the study aims. Primary outcome will be the competency to approach child-related and family-related topics in patients with cancer measured using comprehensive case vignettes. Secondary outcomes will be communication and attitudes regarding child-related and family-related topics and self-efficacy in clinical communication skills. Outcomes will be assessed prior to the training and after the training as well as 3 months after the training. Data will be analysed using descriptive analyses, group comparisons and linear mixed models.
ETHICS AND DISSEMINATION


The study was approved by the Local Psychological Ethics Committee of the Center for Psychosocial Medicine of the University Medical Center Hamburg-Eppendorf (LPEK-001). At the end of the study, a web-based training and a face-to-face training intervention to enhance the competencies of HCPs in caring for patients with cancer having minor children will have been systematically developed and the study design and evaluation concept will have been evaluated. The results of the study will be disseminated through peer-reviewed journals and conference presentations.
TRIAL REGISTRATION NUMBER


DRKS00015794.",2019,Secondary outcomes will be communication and attitudes regarding child-related and family-related topics and self-efficacy in clinical communication skills.,"['patients with cancer having minor children', 'patients with cancer having minor children and their families by enhancing the competencies of healthcare professionals (HCPs, eg, physicians, nurses, psychologists) in caring for patients with cancer having minor children', 'patients with minor children', 'Patients with cancer having minor children experience particular burden and strains']","['training programme', 'face training versus web-based training versus waitlist control group']","['communication and attitudes regarding child-related and family-related topics and self-efficacy in clinical communication skills', 'competency to approach child-related and family-related topics in patients with cancer measured using comprehensive case vignettes']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1704312', 'cui_str': 'Healthcare professional (occupation)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0033908', 'cui_str': 'Psychologist'}, {'cui': 'C0580931', 'cui_str': 'In care (finding)'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0080194', 'cui_str': 'Strains'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0870313', 'cui_str': 'Communication skills'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}]",,0.0566564,Secondary outcomes will be communication and attitudes regarding child-related and family-related topics and self-efficacy in clinical communication skills.,"[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Inhestern', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany l.inhestern@uke.de.'}, {'ForeName': 'Wiebke', 'Initials': 'W', 'LastName': 'Frerichs', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Lene Marie', 'Initials': 'LM', 'LastName': 'Johannsen', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Corinna', 'Initials': 'C', 'LastName': 'Bergelt', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}]",BMJ open,['10.1136/bmjopen-2019-032778']
447,31571526,Sample size considerations for comparing dynamic treatment regimens in a sequential multiple-assignment randomized trial with a continuous longitudinal outcome.,"Clinicians and researchers alike are increasingly interested in how best to personalize interventions. A dynamic treatment regimen is a sequence of prespecified decision rules which can be used to guide the delivery of a sequence of treatments or interventions that is tailored to the changing needs of the individual. The sequential multiple-assignment randomized trial is a research tool which allows for the construction of effective dynamic treatment regimens. We derive easy-to-use formulae for computing the total sample size for three common two-stage sequential multiple-assignment randomized trial designs in which the primary aim is to compare mean end-of-study outcomes for two embedded dynamic treatment regimens which recommend different first-stage treatments. The formulae are derived in the context of a regression model which leverages information from a longitudinal outcome collected over the entire study. We show that the sample size formula for a sequential multiple-assignment randomized trial can be written as the product of the sample size formula for a standard two-arm randomized trial, a deflation factor that accounts for the increased statistical efficiency resulting from a longitudinal analysis, and an inflation factor that accounts for the design of a sequential multiple-assignment randomized trial. The sequential multiple-assignment randomized trial design inflation factor is typically a function of the anticipated probability of response to first-stage treatment. We review modeling and estimation for dynamic treatment regimen effect analyses using a longitudinal outcome from a sequential multiple-assignment randomized trial, as well as the estimation of standard errors. We also present estimators for the covariance matrix for a variety of common working correlation structures. Methods are motivated using the ENGAGE study, a sequential multiple-assignment randomized trial aimed at developing a dynamic treatment regimen for increasing motivation to attend treatments among alcohol- and cocaine-dependent patients.",2020,We derive easy-to-use formulae for computing the total sample size for three common two-stage sequential multiple-assignment randomized trial designs in which the primary aim is to compare mean end-of-study outcomes for two embedded dynamic treatment regimens which recommend different first-stage treatments.,['alcohol- and cocaine-dependent patients'],[],[],"[{'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0581116', 'cui_str': 'Dependent patient (finding)'}]",[],[],,0.0518145,We derive easy-to-use formulae for computing the total sample size for three common two-stage sequential multiple-assignment randomized trial designs in which the primary aim is to compare mean end-of-study outcomes for two embedded dynamic treatment regimens which recommend different first-stage treatments.,"[{'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Seewald', 'Affiliation': 'Department of Statistics, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Kelley M', 'Initials': 'KM', 'LastName': 'Kidwell', 'Affiliation': 'Department of Biostatistics, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Inbal', 'Initials': 'I', 'LastName': 'Nahum-Shani', 'Affiliation': 'Institute for Social Research, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Tianshuang', 'Initials': 'T', 'LastName': 'Wu', 'Affiliation': 'AbbVie, North Chicago, IL, USA.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'McKay', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Almirall', 'Affiliation': 'Department of Statistics, University of Michigan, Ann Arbor, MI, USA.'}]",Statistical methods in medical research,['10.1177/0962280219877520']
448,31659822,Randomised controlled trial of internet-delivered cognitive behaviour therapy for clinical depression and/or anxiety in cancer survivors (iCanADAPT Early).,"PURPOSE


To evaluate internet-delivered cognitive behavioural therapy (iCBT) on clinical depression and/or anxiety, distress, fear of cancer recurrence, and quality of life in cancer survivors.
METHODS


Random assignation of 114 participants to iCBT or treatment-as-usual (TAU). The clinician-supervised iCBT program (iCanADAPT Early) consisted of eight lessons over 16 weeks. Self-report questionnaires occurred at baseline, midpoint, and posttreatment for both groups with 3-month follow-up for iCBT participants. A mixed modelling approach to compare groups occurred.
RESULTS


iCBT was superior to TAU on all outcome measures at posttreatment. Compared with TAU, the iCBT group showed a significant decrease over time in anxiety and depression symptoms (primary outcome, Hospital Anxiety and Depression Scale, Hedges g = 1.51). Additionally the iCBT group had significantly lower general distress (Kessler-10, g = 1.56), fear of cancer recurrence (Fear of Cancer Recurrence Inventory, g = 0.39), and significantly higher quality of life (Functional Assessment of Cancer Therapy-General, g = 0.74) at posttreatment compared with the TAU group. High adherence and satisfaction were found for iCBT with low clinician time.
CONCLUSION


Clinician-supervised iCBT has significant benefits for cancer survivors with clinical depression and anxiety disorders.",2020,"Additionally the iCBT group had significantly lower general distress (Kessler-10, g=1.56), fear of cancer recurrence (Fear of Cancer Recurrence Inventory, g=0.39) and significantly higher quality of life (Functional Assessment of Cancer Therapy-General, g=0.74) at post-treatment compared to the TAU group.","['cancer survivors with clinical depression and anxiety disorders', 'clinical depression and/or anxiety in cancer survivors (iCanADAPT Early', 'Random assignation of 114 participants to iCBT or Treatment-as-usual (TAU']","['internet-delivered cognitive behavioural therapy (iCBT', 'TAU', 'Clinician-supervised iCBT', 'iCBT', 'internet-delivered cognitive behaviour therapy']","['general distress (Kessler-10, g=1.56), fear of cancer recurrence (Fear of Cancer Recurrence Inventory', 'quality of life (Functional Assessment of Cancer Therapy-General', 'High adherence and satisfaction', 'time in anxiety and depression symptoms (primary outcome, Hospital Anxiety and Depression Scale, Hedges g=1.51', 'Self-report questionnaires', 'clinical depression and/or anxiety, distress, fear of cancer recurrence and quality of life']","[{'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C4708785', 'cui_str': 'One hundred and fourteen'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1720655', 'cui_str': 'Tau'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C1720655', 'cui_str': 'Tau'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0233705', 'cui_str': 'Fear of getting cancer (finding)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0034380'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]",114.0,0.0937829,"Additionally the iCBT group had significantly lower general distress (Kessler-10, g=1.56), fear of cancer recurrence (Fear of Cancer Recurrence Inventory, g=0.39) and significantly higher quality of life (Functional Assessment of Cancer Therapy-General, g=0.74) at post-treatment compared to the TAU group.","[{'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Murphy', 'Affiliation': 'Clinical Research Unit for Anxiety and Depression, UNSW, NSW, Australia.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Newby', 'Affiliation': 'Clinical Research Unit for Anxiety and Depression, UNSW, NSW, Australia.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Butow', 'Affiliation': 'Psycho-oncology Co-operative Research Group, University of Sydney, NSW, Australia.'}, {'ForeName': 'S A', 'Initials': 'SA', 'LastName': 'Loughnan', 'Affiliation': 'Clinical Research Unit for Anxiety and Depression, UNSW, NSW, Australia.'}, {'ForeName': 'A E', 'Initials': 'AE', 'LastName': 'Joubert', 'Affiliation': 'Clinical Research Unit for Anxiety and Depression, UNSW, NSW, Australia.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Kirsten', 'Affiliation': 'Psycho-oncology Co-operative Research Group, University of Sydney, NSW, Australia.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Allison', 'Affiliation': 'Psycho-oncology Co-operative Research Group, University of Sydney, NSW, Australia.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Shaw', 'Affiliation': 'Psycho-oncology Co-operative Research Group, University of Sydney, NSW, Australia.'}, {'ForeName': 'H L', 'Initials': 'HL', 'LastName': 'Shepherd', 'Affiliation': 'Psycho-oncology Co-operative Research Group, University of Sydney, NSW, Australia.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Smith', 'Affiliation': 'Clinical Research Unit for Anxiety and Depression, UNSW, NSW, Australia.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Andrews', 'Affiliation': 'Clinical Research Unit for Anxiety and Depression, UNSW, NSW, Australia.'}]",Psycho-oncology,['10.1002/pon.5267']
449,31043657,Effects of Burdock tea on recurrence of colonic diverticulitis and diverticular bleeding: An open-labelled randomized clinical trial.,"Colonic diverticular bleeding (CDB) and acute colonic diverticulitis (ACD) show high recurrence rates. The establishment of optimal strategies that prevent the recurrence of CDB and ACD is a major concern among gastroenterologists. This study aimed to assess the efficacy of burdock tea for preventing CDB and ACD recurrences. Newly diagnosed patients with CDB (n = 91) or ACD (n = 70) were randomly assigned into two groups. The experimental group received 1.5 g of burdock tea three times a day, whereas the control group did not receive any treatment. The median (interquartile range) of observation for recurrence of CDB or ACD was 22.0 (14.1) months and 30.3 (18.6), respectively. The burdock tea treatment showed significant preventive effects on recurrence of ACD. A lower ACD recurrence rate (5/47 [10.6%] vs. 14/44 [31.8%]) and longer recurrence-free duration was observed in the burdock tea group (59.3 months [95% CI: 54.0-64.7] vs. 45.1 months [95% CI: 37.1-53.0] by the Kaplan-Meier analysis; p = 0.012 by log rank test) than in the control group, although there was no significant preventive effects on the CDB recurrence. This randomized clinical trial demonstrated that daily intake of burdock tea could be an effective strategy for prevention of ACD recurrence, but not for CDB recurrence.",2019,Colonic diverticular bleeding (CDB) and acute colonic diverticulitis (ACD) show high recurrence rates.,['Newly diagnosed patients with CDB (n\u2009=\u200991) or ACD (n\u2009=\u200970'],"['Burdock tea', 'burdock tea']","['CDB recurrence', 'recurrence of ACD', 'ACD recurrence rate', 'longer recurrence-free duration', 'recurrence of CDB or ACD', 'recurrence of colonic diverticulitis and diverticular bleeding', 'Colonic diverticular bleeding (CDB) and acute colonic diverticulitis (ACD', 'CDB and ACD recurrences']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1096751', 'cui_str': 'Burdock Plant'}, {'cui': 'C0039400', 'cui_str': 'Tea'}]","[{'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0012814', 'cui_str': 'Colonic Diverticulitis'}, {'cui': 'C4505353', 'cui_str': 'Diverticular Bleeding'}, {'cui': 'C0009368', 'cui_str': 'Colon'}]",,0.149898,Colonic diverticular bleeding (CDB) and acute colonic diverticulitis (ACD) show high recurrence rates.,"[{'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Mizuki', 'Affiliation': 'Department of Internal Medicine, Keiyu Hospital, Yokohama, Japan. amizuki2@yahoo.co.jp.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Tatemichi', 'Affiliation': 'Department of Preventive Medicine, Tokai University School of Medicine, Isehara, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Nakazawa', 'Affiliation': 'Department of Internal Medicine, Saiseikai Central Hospital, Tokyo, Japan.'}, {'ForeName': 'Nobuhiro', 'Initials': 'N', 'LastName': 'Tsukada', 'Affiliation': 'Department of Internal Medicine, Saiseikai Central Hospital, Tokyo, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Nagata', 'Affiliation': 'Department of Internal Medicine, Keiyu Hospital, Yokohama, Japan.'}, {'ForeName': 'Yoshikazu', 'Initials': 'Y', 'LastName': 'Kinoshita', 'Affiliation': 'Department of Gastroenterology and Hepatology, Shimane University School of Medicine, Izumo, Japan.'}]",Scientific reports,['10.1038/s41598-019-43236-0']
450,31043662,Improvement of cognitive control and stabilization of affect by prefrontal transcranial direct current stimulation (tDCS).,"Cognitive control of information processing is an essential prerequisite of human behavior. Particularly, focusing attention in the face of failure poses a common challenge. Previous work has demonstrated that transcranial direct current stimulation (tDCS) of the dorsolateral prefrontal cortex (dlPFC) can improve cognitive control in a challenging and repeatedly frustrating task. In a randomized, sham-controlled, crossover design 22 healthy, male participants performed an adaptive 2-back version of the Paced Auditory Serial Addition Task (PASAT), parallel to anodal or sham tDCS over the left dlPFC and the return electrode on the right upper arm. Before and after the 2-back PASAT, the affective state was assessed by means of the Positive and Negative Affective Schedule (PANAS). We observed an interaction between stimulation condition and task performance driven by an increase in performance with anodal tDCS and no improvement with sham stimulation. In addition, after the 2-back PASAT we found a higher positive and a trend towards lower negative affect with anodal as compared to sham tDCS. Our data support and extend previous results showing improved processing speed under anodal stimulation associated with a reduced task-induced negative affect indicating an improvement of cognitive control. Further studies will investigate long-term effects and clinical applicability.",2019,We observed an interaction between stimulation condition and task performance driven by an increase in performance with anodal tDCS and no improvement with sham stimulation.,"['22 healthy, male participants performed an']","['transcranial direct current stimulation (tDCS', 'adaptive 2-back version of the Paced Auditory Serial Addition Task (PASAT), parallel to anodal or sham tDCS', 'prefrontal transcranial direct current stimulation (tDCS']",['cognitive control'],"[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",22.0,0.0339742,We observed an interaction between stimulation condition and task performance driven by an increase in performance with anodal tDCS and no improvement with sham stimulation.,"[{'ForeName': 'Ariane', 'Initials': 'A', 'LastName': 'Wiegand', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Tübingen, Calwerstrasse 14, 72076, Tübingen, Germany.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Sommer', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Tübingen, Calwerstrasse 14, 72076, Tübingen, Germany.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Nieratschker', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Tübingen, Calwerstrasse 14, 72076, Tübingen, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Plewnia', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Tübingen, Calwerstrasse 14, 72076, Tübingen, Germany. christian.plewnia@uni-tuebingen.de.'}]",Scientific reports,['10.1038/s41598-019-43234-2']
451,31276809,Prophylactic Fentanyl Sublingual Spray for Episodic Exertional Dyspnea in Cancer Patients: A Pilot Double-Blind Randomized Controlled Trial.,"CONTEXT


The optimal dose of fentanyl sublingual spray (FSS) for exertional dyspnea has not been determined.
OBJECTIVES


We examined the effect of two doses of prophylactic FSS on exertional dyspnea.
METHODS


In this parallel, dose-finding, double-blind randomized clinical trial, opioid-tolerant cancer patients completed a shuttle walk test at baseline. Patients completed a second shuttle walk test 10 minutes after a single dose of FSS equivalent to either 35%-45% (high dose) or 15%-25% (low dose) of the total daily opioid dose. The primary outcome was change in modified dyspnea Borg scale (0-10) between the first and second shuttle walk tests. Secondary outcomes included adverse events as well as changes in walk distance, vital signs, and neurocognitive function.
RESULTS


Thirty of the 50 enrolled patients completed the study. High-dose FSS (n = 13) resulted in significantly lower dyspnea (mean change -1.42; 95% CI -2.37, -0.48; P = 0.007) and greater walk distance (mean change 44 m; P = 0.001) compared to baseline. Low-dose FSS (n = 17) resulted in a nonsignificant reduction in dyspnea (mean change -0.47; 95% CI -1.26, 0.32; P = 0.24) and significant increase in walk distance (mean change 24 m; P = 0.01) compared to baseline. Global evaluation showed high-dose group was more likely to report at least somewhat better improvement (64% vs. 24%; P = 0.06). No significant adverse events or detriment to vital signs or neurocognitive function was detected.
CONCLUSION


Prophylactic FSS was well tolerated and demonstrated a dose-response relationship in improving both dyspnea and walk distance. High-dose FSS should be tested in confirmatory trials.",2019,P=0.24) and significant increase in walk distance (mean change 24 m; P=0.01) compared to baseline.,"['Cancer Patients', 'cancer patients', 'Thirty of the 50 enrolled patients completed the study']","['Prophylactic Fentanyl Sublingual Spray', 'opioid-tolerant', 'fentanyl sublingual spray (FSS', 'prophylactic FSS']","['dyspnea', 'vital signs or neurocognitive function', 'exertional dyspnea', 'Episodic Exertional Dyspnea', 'walk distance', 'adverse events as well as changes in walk distance, vital signs, and neurocognitive function', 'modified dyspnea Borg scale']","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C1273658', 'cui_str': 'Sublingual spray'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}]","[{'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0518766'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0231807', 'cui_str': 'Dyspnea on exertion (finding)'}, {'cui': 'C1455761', 'cui_str': 'Episodic (qualifier value)'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0449399', 'cui_str': 'Borg scale (assessment scale)'}]",50.0,0.647755,P=0.24) and significant increase in walk distance (mean change 24 m; P=0.01) compared to baseline.,"[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hui', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, MD Anderson Cancer Center, Houston, Texas, USA. Electronic address: dhui@mdanderson.org.'}, {'ForeName': 'Farley', 'Initials': 'F', 'LastName': 'Hernandez', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Liliana', 'Initials': 'L', 'LastName': 'Larsson', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Liu', 'Affiliation': 'Department of Biostatistics, MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Kilgore', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Naberhuis', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Avery', 'Initials': 'A', 'LastName': 'Virgilio', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Suresh', 'Initials': 'S', 'LastName': 'Reddy', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Akhila', 'Initials': 'A', 'LastName': 'Reddy', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Shalini', 'Initials': 'S', 'LastName': 'Dalal', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Haider', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Larry', 'Initials': 'L', 'LastName': 'Driver', 'Affiliation': 'Department of Pain Medicine, MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Ahsan', 'Initials': 'A', 'LastName': 'Azhar', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Rony', 'Initials': 'R', 'LastName': 'Dev', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Bruera', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, MD Anderson Cancer Center, Houston, Texas, USA.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2019.06.024']
452,31276810,COMPASS: A Pilot Trial of an Early Palliative Care Intervention for Patients With End-Stage Liver Disease.,"CONTEXT


Palliative care interventions have shown promise in improving quality of life and reducing health-care utilization among patients with chronic organ failure.
OBJECTIVES


To evaluate the effect of a palliative care intervention for adults with end-stage liver disease.
METHODS


A randomized controlled trial of patients with end-stage liver disease admitted to the hepatology service at a tertiary referral center whose attending hepatologist indicated they would not be surprised if the patient died in the following year on a standardized questionnaire was performed. Control group patients received usual care. Intervention group patients received inpatient specialist palliative care consultations and outpatient phone follow-up by a palliative care nurse. The primary outcome was time until first readmission. Secondary outcomes included days alive outside the hospital, referral to hospice care, death, readmissions, patient quality of life, depression, anxiety, and quality of end-of-life care over 6 months.
RESULTS


The trial stopped early because of difficulties in accruing patients. Of 293 eligible patients, only 63 patients were enrolled, 31 in the intervention group and 32 in the control group. This pace of enrollment was only 25% of what the study had planned, and so it was deemed infeasible to complete. Despite stopping early, intervention group patients had a lower hazard of readmission (hazard ratio: 0.36, 95% confidence interval: 0.16-0.83, P = 0.017) and greater odds of having more days alive outside the hospital than control group patients (odds ratio: 3.97, 95% confidence interval: 1.14-13.84, P = 0.030). No other statistically significant differences were observed.
CONCLUSION


Logistical obstacles hindered completion of the trial as originally designed. Nevertheless, a preemptive palliative care intervention resulted in increased time to first readmission and more days alive outside the hospital in the first six months after study entry.",2019,"Despite stopping early, intervention group patients had a lower hazard of readmission (HR 0.36, 95% CI 0.16-0.83, p=0.017) and greater odds of having more days alive outside of the hospital than control group patients (OR 3.97, 95% CI: 1.14-13.84, p=0.030).","['adults with end stage liver disease (ESLD', 'Patients with End Stage Liver Disease', 'ESLD patients admitted to the hepatology service at a tertiary referral center whose attending hepatologist indicated they would not be surprised if the patient died in the following year on a standardized questionnaire', 'patients with chronic organ failure', '293 eligible patients, only 63 patients enrolled, 31 in the intervention group and 32 in the control group']","['palliative care intervention', 'COMPASS', 'usual care', 'inpatient specialist palliative care consultations and outpatient phone follow-up by a palliative care nurse', 'Early Palliative Care Intervention']","['time until first readmission', 'hazard of readmission', 'time to first readmission and more days alive outside of the hospital', 'quality of life', 'days alive outside the hospital, referral to hospice care, death, readmissions, patient quality of life, depression, anxiety, and quality of end of life care over 6 months']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0745744', 'cui_str': 'End Stage Liver Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086403', 'cui_str': 'Hepatology'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C4280018', 'cui_str': 'Hepatologists'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C1306577', 'cui_str': 'On examination - dead (finding)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0349410', 'cui_str': 'Single organ dysfunction (disorder)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0700049', 'cui_str': 'Palliative care'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C1273400', 'cui_str': 'Specialist palliative care'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C3714595', 'cui_str': 'Palliative care nurse (occupation)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0034380'}, {'cui': 'C0584064', 'cui_str': 'Referral to hospice (procedure)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0039548', 'cui_str': 'End of Life Care'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]",293.0,0.176169,"Despite stopping early, intervention group patients had a lower hazard of readmission (HR 0.36, 95% CI 0.16-0.83, p=0.017) and greater odds of having more days alive outside of the hospital than control group patients (OR 3.97, 95% CI: 1.14-13.84, p=0.030).","[{'ForeName': 'Myrick C', 'Initials': 'MC', 'LastName': 'Shinall', 'Affiliation': 'Section of Palliative Care, Division of General Internal Medicine and Public Health, Vanderbilt University Medical Center, Nashville, Tennessee, USA; Critical Illness, Brain Dysfunction, and Survivorship Center, Nashville, Tennessee, USA; Department of Surgery, Vanderbilt University Medical Center, Nashville, Tennessee, USA. Electronic address: ricky.shinall@vanderbilt.edu.'}, {'ForeName': 'Mohana', 'Initials': 'M', 'LastName': 'Karlekar', 'Affiliation': 'Section of Palliative Care, Division of General Internal Medicine and Public Health, Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Martin', 'Affiliation': 'Section of Palliative Care, Division of General Internal Medicine and Public Health, Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Cheryl L', 'Initials': 'CL', 'LastName': 'Gatto', 'Affiliation': 'Vanderbilt Institute for Clinical and Translational Research, Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Sumi', 'Initials': 'S', 'LastName': 'Misra', 'Affiliation': 'Section of Palliative Care, Division of General Internal Medicine and Public Health, Vanderbilt University Medical Center, Nashville, Tennessee, USA; Tennessee Valley Geriatrics Research Education and Clinical Center, Veterans Affairs Tennessee Valley Healthcare System, Nashville, Tennessee, USA.'}, {'ForeName': 'Chan Y', 'Initials': 'CY', 'LastName': 'Chung', 'Affiliation': 'Vanderbilt Hepatology and Liver Transplant Center, Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Porayko', 'Affiliation': 'Vanderbilt Hepatology and Liver Transplant Center, Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Andrew E', 'Initials': 'AE', 'LastName': 'Scanga', 'Affiliation': 'Vanderbilt Hepatology and Liver Transplant Center, Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Natasha J', 'Initials': 'NJ', 'LastName': 'Schneider', 'Affiliation': 'Vanderbilt Hepatology and Liver Transplant Center, Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': 'E Wesley', 'Initials': 'EW', 'LastName': 'Ely', 'Affiliation': 'Critical Illness, Brain Dysfunction, and Survivorship Center, Nashville, Tennessee, USA; Tennessee Valley Geriatrics Research Education and Clinical Center, Veterans Affairs Tennessee Valley Healthcare System, Nashville, Tennessee, USA; Division of Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Jill M', 'Initials': 'JM', 'LastName': 'Pulley', 'Affiliation': 'Vanderbilt Institute for Clinical and Translational Research, Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Rebecca N', 'Initials': 'RN', 'LastName': 'Jerome', 'Affiliation': 'Vanderbilt Institute for Clinical and Translational Research, Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Mary Lynn', 'Initials': 'ML', 'LastName': 'Dear', 'Affiliation': 'Vanderbilt Institute for Clinical and Translational Research, Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Conway', 'Affiliation': 'Vanderbilt Institute for Clinical and Translational Research, Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Reagan', 'Initials': 'R', 'LastName': 'Buie', 'Affiliation': 'Vanderbilt Institute for Clinical and Translational Research, Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Dandan', 'Initials': 'D', 'LastName': 'Liu', 'Affiliation': 'Department of Biostatistics, Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Lindsell', 'Affiliation': 'Department of Biostatistics, Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Gordon R', 'Initials': 'GR', 'LastName': 'Bernard', 'Affiliation': 'Vanderbilt Institute for Clinical and Translational Research, Vanderbilt University Medical Center, Nashville, Tennessee, USA; Division of Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2019.06.023']
453,31705529,"Effectiveness of fluoride varnish on caries in the first molars of primary schoolchildren: a 3-year longitudinal study in Guangxi Province, China.","AIMS


To evaluate the effectiveness of 5% sodium fluoride varnish on caries in first permanent molars and to assess the suitability of using this method to control caries among children in rural areas of Guangxi province, China.
METHODS


A total of nine schools with 32 classes were selected by simple random sampling. There were 999 students in the experimental group and 1,004 in the control group. The experimental group received oral health education and topical application of 5% sodium fluoride varnish, while the control group received oral health education only. Dental examinations were performed in November 2014 and November 2017, and the modified International Caries Detection and Assessment System (ICDAS-II) was used to record the caries status of the first permanent molars. The data were entered into SPSS 22 for statistical analysis.
RESULTS


A total of 1,748 students (853 in the experimental group and 895 in the control group) completed the study. After 3 years of intervention, the experimental group had a lower prevalence of caries, a lower caries increment, a lower decayed, missing and filled teeth (DMFT) index and a lower decayed, missing and filled surfaces (DMFS) index compared with the control group (respectively: 58.9% vs 65.5%, 34.8% vs 42.1%, 1.38 vs 1.59 and 2.06 vs 2.38). All the differences were statistically significant (P < 0.05).
CONCLUSION


In this study population, twice-yearly application of 5% sodium fluoride varnish and oral health education were more effective for preventing caries in first permanent molars than oral health education alone. The implementation of fluoride varnish application as a public health measure in schools in rural areas is recommended.",2020,"After 3 years of intervention, the experimental group had a lower prevalence of caries, a lower caries increment, a lower decayed, missing and filled teeth (DMFT) index and a lower decayed, missing and filled surfaces (DMFS) index compared with the control group (respectively: 58.9% vs 65.5%, 34.8% vs 42.1%, 1.38 vs 1.59 and 2.06 vs 2.38).","['Guangxi Province, China', 'A total of nine schools with 32 classes were selected by simple random sampling', 'children in rural areas of Guangxi province, China', '1,748 students (853 in the experimental group and 895 in the control group) completed the study', '999 students in the experimental group and 1,004 in the control group', 'caries in the first molars of primary schoolchildren']","['fluoride varnish', 'sodium fluoride varnish and oral health education', 'fluoride varnish application', 'oral health education and topical application of 5% sodium fluoride varnish, while the control group received oral health education only', 'sodium fluoride varnish']","['prevalence of caries, a lower caries increment, a lower decayed, missing and filled teeth (DMFT) index and a lower decayed, missing and filled surfaces (DMFS) index']","[{'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0333519', 'cui_str': 'Caries (morphologic abnormality)'}, {'cui': 'C0026367', 'cui_str': 'Molar'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}]","[{'cui': 'C0016326', 'cui_str': 'Fluoride Varnishes'}, {'cui': 'C3652487', 'cui_str': 'sodium fluoride (18F)'}, {'cui': 'C0042359', 'cui_str': 'Varnish'}, {'cui': 'C0018703', 'cui_str': 'Health Education, Dental'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0333519', 'cui_str': 'Caries (morphologic abnormality)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0399066', 'cui_str': 'Pack filling'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}]",,0.0190048,"After 3 years of intervention, the experimental group had a lower prevalence of caries, a lower caries increment, a lower decayed, missing and filled teeth (DMFT) index and a lower decayed, missing and filled surfaces (DMFS) index compared with the control group (respectively: 58.9% vs 65.5%, 34.8% vs 42.1%, 1.38 vs 1.59 and 2.06 vs 2.38).","[{'ForeName': 'Shanshan', 'Initials': 'S', 'LastName': 'Wu', 'Affiliation': 'Department of Dental Public Health, College of Stomatology, Guangxi Medical University, Nanning, China.'}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': 'Department of Dental Public Health, College of Stomatology, Guangxi Medical University, Nanning, China.'}, {'ForeName': 'Qiulin', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Department of Dental Public Health, College of Stomatology, Guangxi Medical University, Nanning, China.'}, {'ForeName': 'Xueting', 'Initials': 'X', 'LastName': 'Yu', 'Affiliation': 'Department of Dental Public Health, College of Stomatology, Guangxi Medical University, Nanning, China.'}, {'ForeName': 'Xiaojuan', 'Initials': 'X', 'LastName': 'Zeng', 'Affiliation': 'Department of Dental Public Health, College of Stomatology, Guangxi Medical University, Nanning, China.'}]",International dental journal,['10.1111/idj.12528']
454,32227161,Merely Possessing a Placebo Analgesic Improves Analgesia Similar to Using the Placebo Analgesic.,"BACKGROUND


Placebo analgesia studies generally reported that the actual use of a placebo analgesic reduces pain. Yeung, Geers, and Kam found that the mere possession (without use) of a placebo analgesic also reduces pain.
PURPOSE


We investigated the relative effectiveness of using versus possessing a placebo analgesic on pain outcomes.
METHODS


In Study 1a, 120 healthy adults were randomized to either the experimental (EXP) conditions (EXP1: used a placebo analgesic cream, EXP2: possessed a placebo analgesic cream) or control (CO) conditions (CO1: possessed a sham cream, CO2: no cream). All participants underwent a cold pressor test (CPT). Study 1b further delineated the effect of possession from the effect of use. Sixty healthy adults were randomized to either the placebo-possession condition (merely possessed a placebo analgesic cream) or the placebo-possession-use condition (possessed and used a placebo analgesic cream). All participants did a CPT.
RESULTS


In Study 1a, as expected, a placebo effect was found-participants who used a placebo analgesic cream showed better pain outcomes than the two CO groups. Surprisingly, participants who merely possessed a placebo analgesic cream performed equally well as those who actually used it. In Study 1b, participants in the two conditions did not differ in most pain outcomes. Participants who possessed and used a placebo analgesic cream only showed slightly more reduction in pain intensity compared to participants who merely possessed the placebo analgesic cream.
CONCLUSIONS


Our results suggest that merely possessing a placebo analgesic could enhance pain outcomes similar to that of applying the placebo analgesic.",2020,"Participants who possessed and used a placebo analgesic cream only showed slightly more reduction in pain intensity compared to participants who merely possessed the placebo analgesic cream.
","['120 healthy adults', 'Sixty healthy adults']","['cold pressor test (CPT', 'experimental (EXP) conditions (EXP1: used a placebo analgesic cream, EXP2', 'placebo analgesic cream', 'placebo-possession condition (merely possessed a placebo analgesic cream', 'Placebo Analgesic', 'placebo analgesic cream) or control (CO) conditions (CO1: possessed a sham cream, CO2: no cream', 'placebo analgesic', 'placebo-possession-use condition (possessed and used a placebo analgesic cream']","['pain intensity', 'pain', 'pain outcomes']","[{'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C0444689', 'cui_str': 'Cold pressor test (procedure)'}, {'cui': 'C4521399', 'cui_str': 'LT'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C1378128', 'cui_str': 'Cream'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C1143776', 'cui_str': 'cobalt(II) bis(2,2,6,6-tetramethylheptane-3,5-dionate)'}, {'cui': 'C1947944', 'cui_str': 'Use'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",60.0,0.513031,"Participants who possessed and used a placebo analgesic cream only showed slightly more reduction in pain intensity compared to participants who merely possessed the placebo analgesic cream.
","[{'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Wai-Lan Yeung', 'Affiliation': 'Department of Applied Psychology, Lingnan University, Tuen Mun, Hong Kong.'}, {'ForeName': 'Andrew L', 'Initials': 'AL', 'LastName': 'Geers', 'Affiliation': 'Department of Psychology, University of Toledo, Toledo, OH, USA.'}, {'ForeName': 'Luana', 'Initials': 'L', 'LastName': 'Colloca', 'Affiliation': 'Department of Pain Translational Symptom Science, School of Nursing, University of Maryland, Baltimore, MD, USA.'}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1093/abm/kaaa007']
455,31595627,No effect of CBT-based online self-help training to reduce fear of cancer recurrence: First results of the CAREST multicenter randomized controlled trial.,"OBJECTIVE


Fear of cancer recurrence (FCR) is a common consequence of surviving cancer; therefore, easily accessible self-help training could help many cancer survivors deal with FCR at low costs. The CAncer REcurrence Self-help Training (CAREST) trial evaluates the effectiveness of an online-tailored self-help training on the basis of evidence-based cognitive behavioral therapy principles in breast cancer survivors. Also, possible predictors for benefitting from the online self-help training were examined.
METHODS


This multicenter randomized controlled trial included 262 female breast cancer survivors, randomly assigned to either online self-help training (n = 130) or care as usual (CAU; n = 132). Participants completed questionnaires at baseline (T0), 3 months (T1; after intervention), and 9 months (T2). The primary outcome was FCR (Fear of Cancer Recurrence Inventory Severity subscale). Both effectiveness and predictors were analyzed with latent growth curve modeling (LGCM) according to the intention-to-treat principle.
RESULTS


LGCM showed no differences between the average latent slope in both groups (χ 2   1   = .23, P = .63), suggesting that the treatments did not differ in their change in FCR over time. Moreover, no differences were found in the effects of the predictors on the latent slope in both groups (χ 2   1   = .12, P = .73), suggesting that no significant predictors were found for the effect of the intervention on FCR.
CONCLUSION


There was no effect of the CBT-based online self-help training ""Less fear after cancer"" in the current study. Therefore, we recommend adding professional support to online interventions for FCR.",2020,"There was no effect of the CBT-based online self-help training ""Less fear after cancer"" in the current study.","['n = 130) or care as usual (CAU; n = 132', 'breast cancer survivors', '262 female breast cancer survivors']","['Latent Growth Curve Modeling (LGCM', 'online tailored self-help training, based on evidence-based cognitive behavioral therapy principles', 'online self-help training', 'CBT-based online self-help training']","['fear of cancer recurrence', 'latent slope', 'CAncer REcurrence Self-help Training [CAREST', 'average latent slope', 'FCR', 'FCR (Fear of Cancer Recurrence Inventory Severity subscale']","[{'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0444892', 'cui_str': 'CAU'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0235653', 'cui_str': 'Malignant neoplasm of female breast (disorder)'}]","[{'cui': 'C0205275', 'cui_str': 'Latent (qualifier value)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0233705', 'cui_str': 'Fear of getting cancer (finding)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0205275', 'cui_str': 'Latent (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",262.0,0.0961325,"There was no effect of the CBT-based online self-help training ""Less fear after cancer"" in the current study.","[{'ForeName': 'Sanne Jasperine', 'Initials': 'SJ', 'LastName': 'van Helmondt', 'Affiliation': 'Scientific Research Department, Helen Dowling Institute, Bilthoven, The Netherlands.'}, {'ForeName': 'Marije Liesbeth', 'Initials': 'ML', 'LastName': 'van der Lee', 'Affiliation': 'Scientific Research Department, Helen Dowling Institute, Bilthoven, The Netherlands.'}, {'ForeName': 'Rosalie Antonia Maria', 'Initials': 'RAM', 'LastName': 'van Woezik', 'Affiliation': 'Scientific Research Department, Helen Dowling Institute, Bilthoven, The Netherlands.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Lodder', 'Affiliation': 'Department of Methodology and Statistics, Tilburg University, Tilburg, The Netherlands.'}, {'ForeName': 'Jolanda', 'Initials': 'J', 'LastName': 'de Vries', 'Affiliation': 'Department of Medical and Clinical Psychology, Tilburg University, Tilburg, The Netherlands.'}]",Psycho-oncology,['10.1002/pon.5233']
456,31061515,Short-term mindfulness practice attenuates reward prediction errors signals in the brain.,"Activity changes in dopaminergic neurons encode the ongoing discrepancy between expected and actual value of a stimulus, providing a teaching signal for a reward prediction process. Previous work comparing a cohort of long-term Zen meditators to controls demonstrated an attenuation of reward prediction signals to appetitive reward in the striatum. Using a cross-commodity design encompassing primary- and secondary-reward conditioning experiments, the present study asks the question of whether reward prediction signals are causally altered by mindfulness training in naïve subjects. Volunteers were randomly assigned to 8 weeks of mindfulness training (MT), active control training (CT), or a one-time mindfulness induction group (MI). We observed a decreased response to positive prediction errors in the putamen in the MT group compared to CT using both a primary and a secondary-reward experiment. Furthermore, the posterior insula showed greater activation to primary rewards, independently of their predictability, in the MT group, relative to CT and MI group. These results support the notion that increased attention to the present moment and its interoceptive features - a core component of mindfulness practice - may reduce predictability effects in reward processing, without dampening (in fact, enhancing) the response to the actual delivery of the stimulus.",2019,"Furthermore, the posterior insula showed greater activation to primary rewards, independently of their predictability, in the MT group, relative to CT and MI group.",['naïve subjects'],"['mindfulness training (MT), active control training (CT), or a one-time mindfulness induction group (MI']",[],[],"[{'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]",[],,0.0148045,"Furthermore, the posterior insula showed greater activation to primary rewards, independently of their predictability, in the MT group, relative to CT and MI group.","[{'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Kirk', 'Affiliation': 'Department of Psychology, University of Southern Denmark, Odense, Denmark. ukirk@health.sdu.dk.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Pagnoni', 'Affiliation': 'Department of Biomedical, Metabolic and Neural Sciences, University of Modena and Reggio Emilia, Modena, Italy.'}, {'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Hétu', 'Affiliation': 'Department of Psychology, Université de Montréal, Montréal, Canada.'}, {'ForeName': 'Read', 'Initials': 'R', 'LastName': 'Montague', 'Affiliation': 'Human Neuroimaging Laboratory, Fralin Biomedical Research Institute at VTC, Roanoke, United States.'}]",Scientific reports,['10.1038/s41598-019-43474-2']
457,31233843,"Effect of Opioid Exposure on Efficacy and Tolerability of Sublingual Fentanyl and Subcutaneous Morphine for Severe Cancer Pain Episodes. Secondary Analysis From a Double-Blind Double-Dummy, Randomized Trial.","CONTEXT


Few studies have addressed the impact of previous opioid exposure on the effect of opioids for the treatment of severe cancer pain episodes.
OBJECTIVES


We aimed to test whether previous exposure to higher opioid doses was associated with a reduced analgesic effect of fentanyl sublingual tablets (FST) and subcutaneous morphine (SCM) and whether it had an influence on their relative effect.
METHODS


This is a secondary analysis of a placebo-controlled randomized trial comparing 100 μg FST with 5 mg SCM for the acute treatment of severe cancer pain episodes. The effect of previous opioid exposure (oral morphine equivalent daily dose from 20 to 120 mg) on pain intensity difference (PID) and side effects at 30 and 60 minutes after administration (PID 0-30 minutes, PID 0-60 minutes, and adverse events 30-60 minutes) and on re-medication for inefficacy, was studied by multivariable linear and logistic regression models and statistical tests for interaction.
RESULTS


A total of 114 patients were enrolled. Results indicate modest and nonstatistically significant effect of previous opioid exposure on all the outcomes examined (P = 0.11, P = 0.35, P = 0.07, and P = 0.52, respectively, for PID 0-30 minutes, re-medication, PID 0-60 minutes, and adverse events 30-60 minutes). Nonstatistically significant tests for interaction for all models indicated a lack of impact of previous opioid exposure on the difference in the analgesic effect between treatments.
CONCLUSION


In this study, we could not demonstrate an effect of previous opioid exposure, from 20 to 120 mg oral morphine equivalent daily dose, on the absolute and relative efficacy and tolerability of 100 μg FST and 5 mg SCM for severe cancer pain episodes.",2019,"Results indicate modest and non-statistically significant effect of previous opioid exposure on all the outcomes examined (p=0.11, p=0.35, p=0.07, p=0.52, respectively for PID_0-30, re-medication, PID_0-60, and AEs_30-60). Non-statistically significant tests for interaction for all models, indicated a lack of impact of previous opioid exposure on the difference in the analgesic effect between treatments.
","['114 patients were enrolled', 'severe cancer pain episodes']","['sublingual fentanyl and subcutaneous morphine', 'placebo', 'SCM', 'FST and 5 mg SCM', 'previous opioid exposure (oral morphine', 'fentanyl sublingual tablets (FST) and subcutaneous morphine (SCM', 'opioid exposure']","['analgesic effect', 'pain intensity difference and side effects', 'efficacy and tolerability']","[{'cui': 'C4708785', 'cui_str': 'One hundred and fourteen'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0596240', 'cui_str': 'Tumor-Related Pain'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}]","[{'cui': 'C4521982', 'cui_str': 'Sublingual'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C2961833', 'cui_str': 'Fentanyl Sublingual Tablet'}]","[{'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",114.0,0.0791879,"Results indicate modest and non-statistically significant effect of previous opioid exposure on all the outcomes examined (p=0.11, p=0.35, p=0.07, p=0.52, respectively for PID_0-30, re-medication, PID_0-60, and AEs_30-60). Non-statistically significant tests for interaction for all models, indicated a lack of impact of previous opioid exposure on the difference in the analgesic effect between treatments.
","[{'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Ricchini', 'Affiliation': 'Palliative Care, Pain Therapy and Rehabilitation Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy.'}, {'ForeName': 'Augusto', 'Initials': 'A', 'LastName': 'Caraceni', 'Affiliation': 'Palliative Care, Pain Therapy and Rehabilitation Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy.'}, {'ForeName': 'Ernesto', 'Initials': 'E', 'LastName': 'Zecca', 'Affiliation': 'Palliative Care, Pain Therapy and Rehabilitation Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy. Electronic address: ernesto.zecca@istitutotumori.mi.it.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Pigni', 'Affiliation': 'Palliative Care, Pain Therapy and Rehabilitation Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Centurioni', 'Affiliation': 'Palliative Care, Pain Therapy and Rehabilitation Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Manzoni', 'Affiliation': 'Palliative Care, Pain Therapy and Rehabilitation Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy.'}, {'ForeName': 'Stein', 'Initials': 'S', 'LastName': 'Kaasa', 'Affiliation': 'Department of Cancer Research and Molecular Medicine, European Palliative Care Research Centre, Faculty of Medicine, Norwegian University of Science and Technology, Trondheim, Norway; Department of Oncology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Cinzia', 'Initials': 'C', 'LastName': 'Brunelli', 'Affiliation': 'Palliative Care, Pain Therapy and Rehabilitation Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy; Department of Cancer Research and Molecular Medicine, European Palliative Care Research Centre, Faculty of Medicine, Norwegian University of Science and Technology, Trondheim, Norway.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2019.06.016']
458,31601583,Efficacy and neural mechanism of acupuncture treatment in older adults with subjective cognitive decline: study protocol for a randomised controlled clinical trial.,"INTRODUCTION


Subjective cognitive decline (SCD) refers to individuals' perceived decline in memory and/or other cognitive abilities relative to their previous level of performance, while objective neuropsychological deficits are not observed. SCD may represent a preclinical phase of Alzheimer's disease. At this very early stage of decline, intervention could slow the rate of incipient decline to prolong and preserve cognitive and functional abilities. However, there is no effective treatment recommended for individuals with SCD. Acupuncture, as a non-pharmacological intervention, has been widely employed for patients with cognitive disorders.
METHODS AND ANALYSIS


The proposed study is a randomised, assessor-blinded and placebo-controlled study that investigates the efficacy and mechanism of acupuncture in SCD. Sixty patients with SCD will be randomly allocated either into an acupuncture group or a sham acupuncture group. They will receive 24 sessions of real acupuncture treatment or identical treatment sessions using a placebo needle. Global cognitive changes based on a multidomain neuropsychological test battery will be evaluated to detect the clinical efficacy of acupuncture treatment at baseline and end of treatment. MRI scans will be used to explore acupuncture-related neuroplasticity changes. Correlation analyses will be performed to investigate the relationships between the changes in brain function and symptom improvement.
ETHICS AND DISSEMINATION


The trial was approved by the research ethics committee. The results of the study will be published in a peer-reviewed academic journal and will also be disseminated electronically through conference presentations.
TRIAL REGISTRATION NUMBER


NCT03444896.",2019,Global cognitive changes based on a multidomain neuropsychological test battery will be evaluated to detect the clinical efficacy of acupuncture treatment at baseline and end of treatment.,"['older adults with subjective cognitive decline', 'patients with cognitive disorders', 'individuals with SCD', 'Sixty patients with SCD']","['acupuncture treatment', 'acupuncture', 'acupuncture group or a sham acupuncture', 'placebo', 'placebo needle', 'Acupuncture', 'SCD']","['brain function and symptom improvement', 'Efficacy and neural mechanism']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0234985', 'cui_str': 'Cognitive Decline'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009241', 'cui_str': 'Cognition Disorders'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0964695', 'cui_str': 's(7)(beta)CD'}]","[{'cui': 'C0394664', 'cui_str': 'Acupuncture Treatment'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0398296', 'cui_str': 'Cannulation of vascular fistula, graft or prosthetic device (procedure)'}, {'cui': 'C0964695', 'cui_str': 's(7)(beta)CD'}]","[{'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0441712', 'cui_str': 'Mechanisms (qualifier value)'}]",60.0,0.309853,Global cognitive changes based on a multidomain neuropsychological test battery will be evaluated to detect the clinical efficacy of acupuncture treatment at baseline and end of treatment.,"[{'ForeName': 'Chao-Qun', 'Initials': 'CQ', 'LastName': 'Yan', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Zhou', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'School of Life Sciences, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Jian Feng', 'Initials': 'JF', 'LastName': 'Tu', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Shang-Qing', 'Initials': 'SQ', 'LastName': 'Hu', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Jian-Wei', 'Initials': 'JW', 'LastName': 'Huo', 'Affiliation': 'Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing, China.'}, {'ForeName': 'Zhong-Yan', 'Initials': 'ZY', 'LastName': 'Wang', 'Affiliation': 'Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing, China.'}, {'ForeName': 'Guang-Xia', 'Initials': 'GX', 'LastName': 'Shi', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Ya-Nan', 'Initials': 'YN', 'LastName': 'Zhang', 'Affiliation': 'Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing, China.'}, {'ForeName': 'Jun-Qiu', 'Initials': 'JQ', 'LastName': 'Li', 'Affiliation': 'Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Acupuncture and moxibustion, Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Cun-Zhi', 'Initials': 'CZ', 'LastName': 'Liu', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China lcz_tg@126.com.'}]",BMJ open,['10.1136/bmjopen-2018-028317']
459,31601585,Ward-based Goal-Directed Fluid Therapy (GDFT) in Acute Pancreatitis (GAP) trial: study protocol for a feasibility randomised controlled trial.,"INTRODUCTION


Acute pancreatitis is an inflammatory disease of the pancreas with high risk of developing multiorgan failure and death. There are no effective pharmacological interventions used in current clinical practice. Maintaining fluid and electrolyte balance is the mainstay of supportive management. Goal-directed fluid therapy (GDFT) has been shown to decrease morbidity and mortality in surgical conditions with systemic inflammatory response. There is currently no randomised controlled trial (RCT) investigating the role of GDFT based on cardiac output parameters in patients with acute pancreatitis in the ward setting. A feasibility trial was designed to determine patient and clinician support for recruitment into an RCT of ward-based GDFT in acute pancreatitis, adherence to a GDFT protocol, safety, participant withdrawal, and to determine appropriate endpoints for a subsequent larger trial to evaluate efficacy.
METHODS AND ANALYSIS


The GDFT in Acute Pancreatitis trial is a prospective two-centre feasibility RCT. Eligible adults admitted with new onset of acute pancreatitis will be enrolled and randomised into ward-based GDFT (n=25) or standard fluid therapy (n=25) within 6 hours from the diagnosis and continuing for the following 48 hours. Cardiac output parameters will be monitored with a non-invasive device (Cheetah NICOM; Cheetah Medical). The intervention group will consist of a protocolised GDFT approach consisting of stroke volume optimisation with crystalloid fluid boluses, while the control group will receive standard care fluid therapy as advised by the clinical team. The primary endpoint is feasibility. Secondary endpoints will include safety of the intervention, complications, mortality, admission to intensive care unit, cost and quality of life.
ETHICS AND DISSEMINATION


Ethics approval was granted by the London Central Research Ethics Committee (17/LO/1235, project ID: 221872). The results of this trial will be presented to international conference with interest in general surgery and acute care and published in a peer-reviewed journal.
TRIAL REGISTRATION NUMBER


ISRCTN36077283.",2019,Goal-directed fluid therapy (GDFT) has been shown to decrease morbidity and mortality in surgical conditions with systemic inflammatory response.,"['patients with acute pancreatitis in the ward setting', 'Acute Pancreatitis (GAP) trial', 'Eligible adults admitted with new onset of acute pancreatitis']","['protocolised GDFT approach consisting of stroke volume optimisation with crystalloid fluid boluses, while the control group will receive standard care fluid therapy', 'Ward-based Goal-Directed Fluid Therapy (GDFT', 'standard fluid therapy', 'Goal-directed fluid therapy (GDFT', 'GDFT']","['morbidity and mortality', 'safety of the intervention, complications, mortality, admission to intensive care unit, cost and quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001339', 'cui_str': 'Acute pancreatitis (disorder)'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}]","[{'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0038455', 'cui_str': 'Stroke Volume'}, {'cui': 'C0056562', 'cui_str': 'Crystalloid'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0016286', 'cui_str': 'Fluid Therapy'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}]","[{'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0583239', 'cui_str': 'Admission to intensive care unit (procedure)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0034380'}]",,0.292556,Goal-directed fluid therapy (GDFT) has been shown to decrease morbidity and mortality in surgical conditions with systemic inflammatory response.,"[{'ForeName': 'Farid', 'Initials': 'F', 'LastName': 'Froghi', 'Affiliation': 'Division of Surgery and Interventional Science, University College London, London, UK farid.froghi@nhs.net.'}, {'ForeName': 'Fiammetta', 'Initials': 'F', 'LastName': 'Soggiu', 'Affiliation': 'HPB and Liver Transplantation Surgery, Royal Free Hospital, London, UK.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Ricciardi', 'Affiliation': 'Statistical Sciences, University College London, London, UK.'}, {'ForeName': 'Kurinchi', 'Initials': 'K', 'LastName': 'Gurusamy', 'Affiliation': 'Division of Surgery and Interventional Science, University College London, London, UK.'}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Martin', 'Affiliation': 'Division of Surgery and Interventional Science, University College London, London, UK.'}, {'ForeName': 'Jeshika', 'Initials': 'J', 'LastName': 'Singh', 'Affiliation': 'Health Economics, PHMR, London, UK.'}, {'ForeName': 'Sulman', 'Initials': 'S', 'LastName': 'Siddique', 'Affiliation': 'Division of Surgery and Interventional Science, University College London, London, UK.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Eastgate', 'Affiliation': 'Critical Care Unit, Royal Free Hospital, London, UK.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Ciaponi', 'Affiliation': 'Critical Care Unit, Royal Free Hospital, London, UK.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'McNeil', 'Affiliation': 'Critical Care Unit, Royal Free Hospital, London, UK.'}, {'ForeName': 'Helder', 'Initials': 'H', 'LastName': 'Filipe', 'Affiliation': 'Critical Care Unit, Royal Free Hospital, London, UK.'}, {'ForeName': 'Otto', 'Initials': 'O', 'LastName': 'Schwalowsky-Monks', 'Affiliation': 'Critical Care Unit, Royal Free Hospital, London, UK.'}, {'ForeName': 'Gretchelle', 'Initials': 'G', 'LastName': 'Asis', 'Affiliation': 'Critical Care Unit, Royal Free Hospital, London, UK.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Varcada', 'Affiliation': 'General and Emergency Surgery, Royal Free Hospital, London, UK.'}, {'ForeName': 'Brian R', 'Initials': 'BR', 'LastName': 'Davidson', 'Affiliation': 'HPB and Liver Transplantation Surgery, Royal Free Hospital, London, UK.'}]",BMJ open,['10.1136/bmjopen-2018-028783']
460,31601587,Process evaluation protocol for the I-WOTCH study: an opioid tapering support programme for people with chronic non-malignant pain.,"INTRODUCTION


The Improving the Wellbeing of people with Opioid Treated CHronic Pain (I-WOTCH) randomised controlled trial uses a multicomponent self-management intervention to help people taper their opioid use. This approach is not widely used and its efficacy is unknown. A process evaluation alongside the trial will help to assess how the intervention was delivered, looking at the dose of intervention received and the fidelity of the delivery. We will explore how the intervention may have brought about change through the experiences of the participants receiving and the staff delivering the intervention and whether there were contextual factors involved.
METHODS AND ANALYSIS


A mixed methods process evaluation will assess how the processes of the I-WOTCH intervention fared and whether these affected the outcomes. We will collect quantitative data, for example, group attendance analysed with statistical methods. Qualitative data, for example, from interviews and feedback forms will be analysed using framework analysis. We will use a 'following a thread' and a mixed methods matrix for the final integrated analysis.
ETHICS AND DISSEMINATION


The I-WOTCH trial and process evaluation were granted full ethics approval by Yorkshire and The Humber-South Yorkshire Research Ethics Committee on 13 September 2016 (16/YH/0325). All data were collected in accordance with data protection guidelines. Participants provided written informed consent for the main trial, and all interviewees provided additional written informed consent. The results of the process evaluation will be published and presented at conferences.
TRIAL REGISTRATION NUMBER


ISRCTN49470934; Pre-results.",2019,The Improving the Wellbeing of people with Opioid Treated CHronic Pain (I-WOTCH) randomised controlled trial uses a multicomponent self-management intervention to help people taper their opioid use.,"['people with Opioid Treated CHronic Pain (I-WOTCH', 'people with chronic non-malignant pain']","['multicomponent self-management intervention', 'opioid tapering support programme']",[],"[{'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0205282', 'cui_str': 'Malignant (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]",[],,0.160763,The Improving the Wellbeing of people with Opioid Treated CHronic Pain (I-WOTCH) randomised controlled trial uses a multicomponent self-management intervention to help people taper their opioid use.,"[{'ForeName': 'Vivien P', 'Initials': 'VP', 'LastName': 'Nichols', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK v.p.nichols@warwick.ac.uk.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Abraham', 'Affiliation': 'Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, UK.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Eldabe', 'Affiliation': 'Department of Pain Medicine, The James Cook University Hospital, Middlesbrough, UK.'}, {'ForeName': 'Harbinder K', 'Initials': 'HK', 'LastName': 'Sandhu', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Underwood', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Seers', 'Affiliation': 'Warwick Research in Nursing, Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-028998']
461,32239161,Role of Persistent and Worsening Sleep Disturbance in Depression Remission and Suicidal Ideation Among Older Primary Care Patients: The PROSPECT Study.,"STUDY OBJECTIVES


We analyzed data from a practice-based randomized controlled trial within 20 primary care practices located in greater New York City, Philadelphia, and Pittsburgh to determine whether persistent or worsening sleep disturbance plays a role in the outcomes of depression and suicidal ideation at 1 year in older adults with depression.
METHODS


The study sample consisted of 599 adults aged 60 years and older meeting criteria for major depression or clinically significant minor depression. Longitudinal analysis via growth curve mixture modeling was carried out to classify patients as having worsening, persistent, or improving sleep over 1 year.
RESULTS


At 1-year follow-up, compared with patients with improving sleep, those with worsening sleep were more likely to have a diagnosis of major depression (adjusted odds ratio (aOR) = 28.60, 95% confidence interval (CI) 12.15 to 67.34), a diagnosis of clinically significant minor depression (aOR = 11.88, 95% CI 5.67 to 24.89), and suicidal ideation (aOR = 1.10, 1.005 to 1.199), and were half as likely to achieve remission (aOR = 0.52, 95% CI 0.46 to 0.57). Patients with persistent sleep disturbance showed similar but attenuated results.
CONCLUSIONS


Older primary care patients with depression who exhibit worsening or persistent sleep disturbance were at increased risk for persistent depression and suicidal ideation 1 year later. The pattern of sleep disturbance over time may be an important signal for exploration by primary care physicians of depression and suicidal ideation among older adults with depression.",2020,"Patients with persistent sleep disturbance showed similar but attenuated results.
","['older adults with depression', '599 adults aged 60 years and older meeting criteria for major depression or clinically significant minor depression', 'Older Primary Care Patients', '20 primary care practices located in greater New York City, Philadelphia, and Pittsburgh to determine whether persistent or worsening sleep disturbance', 'Older primary care patients with depression who exhibit worsening or persistent sleep disturbance']",[],"['diagnosis of major depression', 'suicidal ideation']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0556656', 'cui_str': 'Meetings'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0027977', 'cui_str': 'New York City'}, {'cui': 'C0031525', 'cui_str': 'Philadelphia'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0015272', 'cui_str': 'Exhibits as Topic'}]",[],"[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}]",599.0,0.0662918,"Patients with persistent sleep disturbance showed similar but attenuated results.
","[{'ForeName': 'Joseph J', 'Initials': 'JJ', 'LastName': 'Gallo', 'Affiliation': 'Department of Mental Health, Johns Hopkins University Bloomberg School of Public Health.'}, {'ForeName': 'Seungyoung', 'Initials': 'S', 'LastName': 'Hwang', 'Affiliation': 'Department of Health Policy and Management Johns Hopkins University Bloomberg School of Public Health.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Truong', 'Affiliation': 'Department of Mental Health, Johns Hopkins University Bloomberg School of Public Health.'}, {'ForeName': 'Charles F', 'Initials': 'CF', 'LastName': 'Reynolds', 'Affiliation': 'Department of Psychiatry University of Pittsburgh School of Medicine Pittsburgh, Pennsylvania.'}, {'ForeName': 'Adam P', 'Initials': 'AP', 'LastName': 'Spira', 'Affiliation': 'Department of Mental Health, Johns Hopkins University Bloomberg School of Public Health.'}]",Sleep,['10.1093/sleep/zsaa063']
462,32234700,Efficacy of a Theory-Based Cognitive Behavioral Technique App-Based Intervention for Patients With Insomnia: Randomized Controlled Trial.,"BACKGROUND


Sleep hygiene is important for maintaining good sleep and reducing insomnia.
OBJECTIVE


This study examined the long-term efficacy of a theory-based app (including cognitive behavioral therapy [CBT], theory of planned behavior [TPB], health action process approach [HAPA], and control theory [CT]) on sleep hygiene among insomnia patients.
METHODS


The study was a 2-arm single-blind parallel-group randomized controlled trial (RCT). Insomnia patients were randomly assigned to a treatment group that used an app for 6 weeks (ie, CBT for insomnia [CBT-I], n=156) or a control group that received only patient education (PE, n=156) through the app. Outcomes were assessed at baseline and 1 month, 3 months, and 6 months postintervention. Primary outcomes were sleep hygiene, insomnia, and sleep quality. Secondary outcomes included attitudes toward sleep hygiene behavior, perceived behavioral control, behavioral intention, action and coping planning, self-monitoring, behavioral automaticity, and anxiety and depression. Linear mixed models were used to evaluate the magnitude of changes in outcomes between the two groups and across time.
RESULTS


Sleep hygiene was improved in the CBT-I group compared with the PE group (P=.02 at 1 month, P=.04 at 3 months, and P=.02 at 6 months) as were sleep quality and severity of insomnia. Mediation analyses suggested that perceived behavioral control on sleep hygiene as specified by TPB along with self-regulatory processes from HAPA and CT mediated the effect of the intervention on outcomes.
CONCLUSIONS


Health care providers might consider using a CBT-I app to improve sleep among insomnia patients.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03605732; https://clinicaltrials.gov/ct2/show/NCT03605732.",2020,"RESULTS


Sleep hygiene was improved in the CBT-I group compared with the PE group (P=.02 at 1 month, P=.04 at 3 months, and P=.02 at 6 months) as were sleep quality and severity of insomnia.","['insomnia patients', 'Insomnia patients', 'Patients With Insomnia']","['theory-based app (including cognitive behavioral therapy [CBT', 'Theory-Based Cognitive Behavioral Technique App-Based Intervention', 'control theory [CT', 'control group that received only patient education (PE, n=156) through the app']","['sleep quality and severity of insomnia', 'sleep hygiene', 'attitudes toward sleep hygiene behavior, perceived behavioral control, behavioral intention, action and coping planning, self-monitoring, behavioral automaticity, and anxiety and depression', 'Sleep hygiene', 'sleep hygiene, insomnia, and sleep quality']","[{'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030688', 'cui_str': 'Patient education'}]","[{'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C4277672', 'cui_str': 'Good Sleep Habits'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",156.0,0.0873581,"RESULTS


Sleep hygiene was improved in the CBT-I group compared with the PE group (P=.02 at 1 month, P=.04 at 3 months, and P=.02 at 6 months) as were sleep quality and severity of insomnia.","[{'ForeName': 'Nilofar', 'Initials': 'N', 'LastName': 'Rajabi Majd', 'Affiliation': 'Social Determinants of Health Research Center, Research Institute for Prevention of Non-Communicable Diseases, Qazvin University of Medical Sciences, Qazvin, Iran.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Broström', 'Affiliation': 'Department of Nursing, School of Health and Welfare, Jönköping University, Jönköping, Sweden.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Ulander', 'Affiliation': 'Department of Clinical Neurophysiology, Linköping University Hospital, Linköping, Sweden.'}, {'ForeName': 'Chung-Ying', 'Initials': 'CY', 'LastName': 'Lin', 'Affiliation': 'Department of Rehabilitation Sciences, Hong Kong Polytechnic University, Hung Hom, China (Hong Kong).'}, {'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'Griffiths', 'Affiliation': 'International Gaming Research Unit, Psychology Department, Nottingham Trent University, Nottingham, United Kingdom.'}, {'ForeName': 'Vida', 'Initials': 'V', 'LastName': 'Imani', 'Affiliation': 'Pediatric Health Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Daniel Kwasi', 'Initials': 'DK', 'LastName': 'Ahorsu', 'Affiliation': 'Department of Rehabilitation Sciences, Hong Kong Polytechnic University, Hung Hom, China (Hong Kong).'}, {'ForeName': 'Maurice M', 'Initials': 'MM', 'LastName': 'Ohayon', 'Affiliation': 'Division of Public Mental Health and Population Sciences, Stanford Sleep Epidemiology Research Center, Stanford University, Palo Alto, CA, United States.'}, {'ForeName': 'Amir H', 'Initials': 'AH', 'LastName': 'Pakpour', 'Affiliation': 'Social Determinants of Health Research Center, Research Institute for Prevention of Non-Communicable Diseases, Qazvin University of Medical Sciences, Qazvin, Iran.'}]",Journal of medical Internet research,['10.2196/15841']
463,31985462,Machine Learning Predictive Models Can Improve Efficacy of Clinical Trials for Alzheimer's Disease.,"BACKGROUND


The ideal participants for Alzheimer's disease (AD) clinical trials would show cognitive decline in the absence of treatment (i.e., placebo arm) and also would be responsive to the therapeutic intervention being studied (i.e., drug arm). One strategy to boost the power of trials is to enroll individuals who are more likely to progress targeted using data-driven predictive models.
OBJECTIVE


To investigate if machine learning (ML) models can effectively predict clinical disease progression (cognitive decline) in mild-to-moderate AD patients during the timeframe of a phase III clinical trial.
METHODS


Data from 202 participants with a diagnosis of AD at baseline from the Alzheimer's Disease Neuroimaging Initiative (ADNI) was used to train ML classifiers that can differentiate between individuals who had declining cognitive function (DC) and individuals with stable cognitive function (SC). DC was defined as any downward change in the Alzheimer's Disease Assessment Scale cognitive subscale (ADAS-cog) score over 12 months of follow-up. SC was defined by the absence of decline in ADAS-cog. Trained models were applied to data from 77 participants from the placebo arm of the phase III trial of Semagacestat (LFAN study) to identify subgroups of SC versus DC.
RESULTS


Only 74.8% of ADNI participants and 63.6% of LFAN participants had cognitive decline after one year of follow up. K-nearest neighbors (kNN) classifier had an accuracy of 68.3%, sensitivity of 80.1%, and specificity of 33.3% for identifying decliners in ADNI (training sample). In LFAN (validation sample), the model showed an overall accuracy of 61.3%, sensitivity of 65.5%, and specificity of 47.0% in identifying decliners at the 12 months of follow-up. The model had a positive predictive value of 80.8%, which was 17.2% more than the base prevalence of decliners.
CONCLUSIONS


Machine learning predictive models can be effectively used to boost the power of clinical trials by reducing the sample size.",2020,"In LFAN (validation sample), the model showed an overall accuracy of 61.3%, sensitivity of 65.5%, and specificity of 47.0% in identifying decliners at the 12 months of follow-up.","['77 participants from the', ""202 participants with a diagnosis of AD at baseline from the Alzheimer's Disease Neuroimaging Initiative (ADNI) was used to train ML classifiers that can differentiate between individuals who had declining cognitive function (DC) and individuals with stable cognitive function (SC"", 'mild-to-moderate AD patients during the timeframe of a phase III clinical trial']","['LFAN', 'placebo', 'machine learning (ML) models']","['cognitive decline', ""Alzheimer's Disease Assessment Scale cognitive subscale (ADAS-cog) score""]","[{'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0424093', 'cui_str': 'Initiative (observable entity)'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0205615', 'cui_str': 'Well differentiated (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1096780', 'cui_str': 'Clinical Trial, Phase 3'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0376284', 'cui_str': 'Machine Learning'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}]","[{'cui': 'C0234985', 'cui_str': 'Cognitive Decline'}, {'cui': 'C0450989', 'cui_str': ""Alzheimer's disease assessment scale (assessment scale)""}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",202.0,0.226127,"In LFAN (validation sample), the model showed an overall accuracy of 61.3%, sensitivity of 65.5%, and specificity of 47.0% in identifying decliners at the 12 months of follow-up.","[{'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Ezzati', 'Affiliation': 'Department of Neurology, Albert Einstein College of Medicine and Montefiore Medical Center, Bronx, NY, USA.'}, {'ForeName': 'Richard B', 'Initials': 'RB', 'LastName': 'Lipton', 'Affiliation': 'Department of Neurology, Albert Einstein College of Medicine and Montefiore Medical Center, Bronx, NY, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-190822']
464,32068436,"Safety, Immunogenicity, and Glycemic Control of Insulin Aspart Biosimilar SAR341402 Versus Originator Insulin Aspart in People with Diabetes Also Using Insulin Glargine: 12-Month Results from the GEMELLI 1 Trial.","Background:  SAR341402 (SAR-Asp) is a biosimilar/follow-on of the originator insulin aspart-NovoLog ® /NovoRapid ®  (NN-Asp). This study investigated whether the efficacy, safety, and immunogenicity findings for SAR-Asp versus NN-Asp, observed over 6 months in people with type 1 ( n  = 497) or type 2 diabetes ( n  = 100) treated with multiple daily injections in combination with insulin glargine (Lantus ® ), are maintained after 12 months.  Materials and Methods:  GEMELLI 1 was a multicenter, randomized, open-label, phase 3 study. Participants completing the initial 6-month treatment period continued on SAR-Asp or NN-Asp, as randomized, for a 6-month safety extension.  Results:  Of the 597 participants randomized, 264 out of 301 (87.7%) and 263 out of 296 (88.9%) assigned to SAR-Asp and NN-Asp, respectively, completed 12 months of treatment. Improved glycemic control was sustained at 12 months in both treatment groups, with similar least-squares mean reductions in glycated hemoglobin (HbA1c) from baseline (SAR-Asp: -0.25%; NN-Asp: -0.26%). Fasting plasma glucose and seven-point self-monitored plasma glucose profile changes, including postprandial glucose excursions, and changes in mealtime and basal insulin dosages were similar between groups. Safety and tolerability, including anti-insulin aspart antibodies (AIAs; incidence, prevalence, titers, cross-reactivity to human insulin), neutralizing antibodies (incidence, prevalence), hypoglycemia, and treatment-emergent adverse events (including hypersensitivity events and injection site reactions), were similar between groups. No relationship was observed between maximum individual AIA titers and change in HbA1c or insulin dose, hypoglycemia, or hypersensitivity reactions or between efficacy/safety measures and subgroups by presence or absence of treatment-emergent AIA.  Conclusions:  SAR-Asp and NN-Asp demonstrated similar efficacy and safety (including immunogenicity) in people with diabetes over 12 months of treatment.",2020,SAR-Asp and NN-Asp demonstrated similar efficacy and safety (including immunogenicity) in people with diabetes over 12 months treatment.,"['people with type 1 (T1D, n=497) or type 2 diabetes (T2D, n=100) treated with', 'people with diabetes over 12 months treatment', 'People with Diabetes also Using Insulin Glargine']","['Insulin Aspart Biosimilar SAR341402 Versus Originator Insulin Aspart', 'multiple daily injections in combination with insulin glargine (Lantus®']","['maximum individual AIA titers and change in HbA1c or insulin dose, hypoglycemia, or hypersensitivity reactions', 'glycemic control', 'Safety and tolerability, including anti-insulin aspart antibodies (AIA; incidence, prevalence, titers, cross-reactivity to human insulin), neutralizing antibodies (incidence, prevalence), hypoglycemia, treatment-emergent adverse events (including hypersensitivity events and injection site reactions', 'efficacy and safety (including immunogenicity', 'Fasting plasma glucose and seven-point self-monitored plasma glucose profile changes, including postprandial glucose excursions, and changes in mealtime and basal insulin dosages']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}]","[{'cui': 'C0123677', 'cui_str': 'Insulin, Aspart, Human'}, {'cui': 'C4045974', 'cui_str': 'Biosimilars'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C0876064', 'cui_str': 'Lantus'}]","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0020517', 'cui_str': 'Allergy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0123677', 'cui_str': 'Insulin, Aspart, Human'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0795635', 'cui_str': 'insulin (human)'}, {'cui': 'C1142254', 'cui_str': 'Neutralising antibodies'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3544362', 'cui_str': 'Hypersensitivity (SMQ)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0151735', 'cui_str': 'Injection Site Adverse Event'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0587119', 'cui_str': 'Meal Times'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0178602', 'cui_str': 'Dosages (qualifier value)'}]",597.0,0.0510182,SAR-Asp and NN-Asp demonstrated similar efficacy and safety (including immunogenicity) in people with diabetes over 12 months treatment.,"[{'ForeName': 'Satish K', 'Initials': 'SK', 'LastName': 'Garg', 'Affiliation': 'Barbara Davis Center for Diabetes, University of Colorado Anschutz Medical Campus, Aurora, Colorado.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Wernicke-Panten', 'Affiliation': 'Sanofi-Aventis Deutschland GmbH, Frankfurt, Germany.'}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Wardecki', 'Affiliation': 'Sanofi, Warszawa, Poland.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Kramer', 'Affiliation': 'Sanofi-Aventis Deutschland GmbH, Frankfurt, Germany.'}, {'ForeName': 'Francois', 'Initials': 'F', 'LastName': 'Delalande', 'Affiliation': 'Ividata, Paris, France.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Franek', 'Affiliation': 'Mossakowski Clinical Research Centre, Polish Academy of Sciences, Warszawa, Poland.'}, {'ForeName': 'Karita', 'Initials': 'K', 'LastName': 'Sadeharju', 'Affiliation': 'Terveystalo Seinäjoki, Seinäjoki, Finland.'}, {'ForeName': 'Travis', 'Initials': 'T', 'LastName': 'Monchamp', 'Affiliation': 'Endocrinology Services Northwest, Bend, Oregon.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Miossec', 'Affiliation': 'Sanofi, Paris, France.'}, {'ForeName': 'Bhaswati', 'Initials': 'B', 'LastName': 'Mukherjee', 'Affiliation': 'Sanofi, Paris, France.'}, {'ForeName': 'Viral N', 'Initials': 'VN', 'LastName': 'Shah', 'Affiliation': 'Barbara Davis Center for Diabetes, University of Colorado Anschutz Medical Campus, Aurora, Colorado.'}]",Diabetes technology & therapeutics,['10.1089/dia.2020.0008']
465,31325546,A Comparison of Rural and Urban Hospice Family Caregivers' Cancer Pain Knowledge and Experience.,"CONTEXT


Family caregivers play a vital role in managing the pain of hospice patients with cancer; however, caregivers' knowledge of pain management principles and experiences as pain managers vary widely. Differences in cultural values and access to resources suggest that rural and urban hospice family caregivers may differ with regard to their pain knowledge and experience, but this has not been empirically investigated.
OBJECTIVES


We sought to determine if rural and urban hospice family caregivers differed in terms of their knowledge of cancer pain management principles and their experiences managing cancer pain.
METHODS


Our study consisted of a secondary analysis of baseline, cross-sectional data from hospice family caregivers (N = 196) participating in an ongoing cluster randomized crossover pragmatic trial. We performed multivariable regression to model associations between caregivers' demographic characteristics and their scores on the Family Pain Questionnaire (FPQ), which included subscales measuring pain knowledge and experience.
RESULTS


When controlling for other demographic variables, rural caregivers' scores on the FPQ knowledge subscale were worse (P = 0.01) than their urban counterparts. FPQ experience subscale scores and FPQ total scores were not statistically significantly different between the two groups.
CONCLUSION


Rural hospice family caregivers report greater pain knowledge deficits than urban hospice family caregivers, although the two groups report comparable pain management experiences. Additional research is needed to better explain observed differences.",2019,"Rural hospice family caregivers report greater pain knowledge deficits than urban hospice family caregivers, although the two groups report comparable pain management experiences.","['urban hospice family caregivers', 'hospice family caregivers (N\xa0=\xa0196) participating', 'hospice patients with cancer', ""Rural and Urban Hospice Family Caregivers' Cancer Pain Knowledge and Experience"", 'rural and urban hospice family caregivers']",[],"['Family Pain Questionnaire (FPQ', 'FPQ knowledge subscale', 'FPQ experience subscale scores and FPQ total scores', 'pain knowledge deficits']","[{'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0019947', 'cui_str': 'Hospices'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0596240', 'cui_str': 'Tumor-Related Pain'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",[],"[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0459443', 'cui_str': 'Subscale score (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1998986', 'cui_str': 'Deficient knowledge'}]",,0.0276867,"Rural hospice family caregivers report greater pain knowledge deficits than urban hospice family caregivers, although the two groups report comparable pain management experiences.","[{'ForeName': 'Karla T', 'Initials': 'KT', 'LastName': 'Washington', 'Affiliation': 'Department of Family and Community Medicine, University of Missouri, Columbia, Missouri, USA. Electronic address: washingtonkar@health.missouri.edu.'}, {'ForeName': 'Debra Parker', 'Initials': 'DP', 'LastName': 'Oliver', 'Affiliation': 'Department of Family and Community Medicine, University of Missouri, Columbia, Missouri, USA.'}, {'ForeName': 'Jamie B', 'Initials': 'JB', 'LastName': 'Smith', 'Affiliation': 'Department of Family and Community Medicine, University of Missouri, Columbia, Missouri, USA.'}, {'ForeName': 'Robin L', 'Initials': 'RL', 'LastName': 'Kruse', 'Affiliation': 'Department of Family and Community Medicine, University of Missouri, Columbia, Missouri, USA.'}, {'ForeName': 'Salimah H', 'Initials': 'SH', 'LastName': 'Meghani', 'Affiliation': 'School of Nursing, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Demiris', 'Affiliation': 'Schools of Nursing and Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2019.07.010']
466,31517663,"Safety, Efficacy, and Patient Satisfaction With OnabotulinumtoxinA for the Treatment of Upper Facial Lines in Japanese Subjects.","BACKGROUND


OnabotulinumtoxinA treatment for glabellar lines (GL) or crow's-feet lines (CFL) was previously studied in Japanese subjects.
OBJECTIVE


To assess safety and efficacy of repeated onabotulinumtoxinA for moderate to severe GL and CFL in Japanese subjects.
METHODS


This 13-month, double-blind, Phase 3 study randomized subjects to onabotulinumtoxinA 44 U (n = 48) or 32 U (n = 53) for CFL and GL for up to 5 treatments (CFL: 24 U or 12 U; GL: 20 U). Outcomes included proportion of subjects achieving none/mild severity at maximum smile (CFL) and maximum frown (GL), using the Facial Wrinkle Scale with Asian Photonumeric Guide (FWS-A); proportion of ≥1-grade improvement responders at maximum smile and at rest (CFL), at maximum frown and at rest (GL); subject-reported outcomes; and safety.
RESULTS


Most subjects were responders (none/mild on FWS-A; CFL: 89.6% [44 U], 84.9% [32 U]; GL: 93.8% [44 U], 98.1% [32 U]) on Day 30. Across treatment groups, responder rates were consistent over time and treatments. Most subjects were satisfied with improved CFL appearance and with treatment. Incidence of treatment-emergent adverse events (TEAEs) and treatment-related TEAEs across groups was similar. All TEAEs but one (peritonitis) were mild or moderate.
CONCLUSION


Repeated onabotulinumtoxinA was effective and well tolerated.",2020,Incidence of treatment-emergent adverse events (TEAEs) and treatment-related TEAEs across groups was similar.,"['Japanese subjects', ""glabellar lines (GL) or crow's-feet lines (CFL) was previously studied in Japanese subjects"", 'Japanese Subjects', '44 U (n = 48) or 32 U (n = 53) for']","['onabotulinumtoxinA', 'CFL and GL', 'OnabotulinumtoxinA', 'CFL']","['responder rates', 'proportion of subjects achieving none/mild severity at maximum smile (CFL) and maximum frown (GL), using the Facial Wrinkle Scale with Asian Photonumeric Guide (FWS-A); proportion of ≥1-grade improvement responders at maximum smile and at rest (CFL), at maximum frown and at rest (GL); subject-reported outcomes; and safety', 'effective and well tolerated', 'Safety, Efficacy, and Patient Satisfaction', 'CFL appearance', 'safety and efficacy']","[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0442019', 'cui_str': 'Glabellar (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0277939', 'cui_str': ""Crow's feet (finding)""}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C2719767', 'cui_str': 'onabotulinumtoxinA'}]","[{'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0037363', 'cui_str': 'Smilings'}, {'cui': 'C0262478', 'cui_str': 'Wrinkled face (finding)'}, {'cui': 'C0222045'}, {'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0443144', 'cui_str': 'At rest (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0700364', 'cui_str': 'Appearances (qualifier value)'}]",,0.0343399,Incidence of treatment-emergent adverse events (TEAEs) and treatment-related TEAEs across groups was similar.,"[{'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Kawashima', 'Affiliation': ""Department of Dermatology, Tokyo Women's Medical University School of Medicine, Tokyo, Japan.""}, {'ForeName': 'Kiyonori', 'Initials': 'K', 'LastName': 'Harii', 'Affiliation': 'Department of Plastic Surgery, Kyorin University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Horiuchi', 'Affiliation': 'Akihabara Skin Clinic, Tokyo, Japan.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Seidman', 'Affiliation': 'Peloton Advantage, LLC, Parsippany, New Jersey.'}, {'ForeName': 'Xiaofang', 'Initials': 'X', 'LastName': 'Lei', 'Affiliation': 'Allergan plc, Irvine, California.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Hopfinger', 'Affiliation': 'Allergan plc, Irvine, California.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Lee', 'Affiliation': 'Allergan plc, Irvine, California.'}]",Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.],['10.1097/DSS.0000000000002143']
467,31619413,Pragmatic randomised clinical trial of proton versus photon therapy for patients with non-metastatic breast cancer: the Radiotherapy Comparative Effectiveness (RadComp) Consortium trial protocol.,"INTRODUCTION


A broad range of stakeholders have called for randomised evidence on the potential clinical benefits and harms of proton therapy, a type of radiation therapy, for patients with breast cancer. Radiation therapy is an important component of curative treatment, reducing cancer recurrence and extending survival. Compared with photon therapy, the international treatment standard, proton therapy reduces incidental radiation to the heart. Our overall objective is to evaluate whether the differences between proton and photon therapy cardiac radiation dose distributions lead to meaningful reductions in cardiac morbidity and mortality after treatment for breast cancer.
METHODS


We are conducting a large scale, multicentre pragmatic randomised clinical trial for patients with breast cancer who will be followed longitudinally for cardiovascular morbidity and mortality, health-related quality of life and cancer control outcomes. A total of 1278 patients with non-metastatic breast cancer will be randomly allocated to receive either photon or proton therapy. The primary outcomes are major cardiovascular events, defined as myocardial infarction, coronary revascularisation, cardiovascular death or hospitalisation for unstable angina, heart failure, valvular disease, arrhythmia or pericardial disease. Secondary endpoints are urgent or unanticipated outpatient or emergency room visits for heart failure, arrhythmia, valvular disease or pericardial disease. The Radiotherapy Comparative Effectiveness (RadComp) Clinical Events Centre will conduct centralised, blinded adjudication of primary outcome events.
ETHICS AND DISSEMINATION


The RadComp trial has been approved by the institutional review boards of all participating sites. Recruitment began in February 2016. Current version of the protocol is A3, dated 08 November 2018. Dissemination plans include presentations at scientific conferences, scientific publications, stakeholder engagement efforts and presentation to the public via lay media outlets.
TRIAL REGISTRATION NUMBER


NCT02603341.",2019,"The primary outcomes are major cardiovascular events, defined as myocardial infarction, coronary revascularisation, cardiovascular death or hospitalisation for unstable angina, heart failure, valvular disease, arrhythmia or pericardial disease.","['patients with breast cancer who will be followed longitudinally for cardiovascular morbidity and mortality, health-related quality of life and cancer control outcomes', 'patients with non-metastatic breast cancer', '1278 patients with non-metastatic breast cancer', 'patients with breast cancer']","['proton versus photon therapy', 'proton therapy', 'photon or proton therapy', 'Radiotherapy Comparative Effectiveness (RadComp', 'Radiation therapy']","['major cardiovascular events, defined as myocardial infarction, coronary revascularisation, cardiovascular death or hospitalisation for unstable angina, heart failure, valvular disease, arrhythmia or pericardial disease', 'cardiac morbidity and mortality', 'cancer recurrence and extending survival', 'urgent or unanticipated outpatient or emergency room visits for heart failure, arrhythmia, valvular disease or pericardial disease']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1301700', 'cui_str': 'Cardiovascular morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer metastatic'}]","[{'cui': 'C0033727', 'cui_str': 'Hydrogen Ions'}, {'cui': 'C0086805', 'cui_str': 'Photons'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0436226', 'cui_str': 'Proton Beam Radiation Therapy'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0034619', 'cui_str': 'radiation therapy'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0002965', 'cui_str': 'Angina at Rest'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0003811', 'cui_str': 'Arrhythmia'}, {'cui': 'C0265122', 'cui_str': 'Disorder of pericardium (disorder)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0231449', 'cui_str': 'Extended (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C1704447', 'cui_str': 'Patient visit for (contextual qualifier) (qualifier value)'}]",1278.0,0.145815,"The primary outcomes are major cardiovascular events, defined as myocardial infarction, coronary revascularisation, cardiovascular death or hospitalisation for unstable angina, heart failure, valvular disease, arrhythmia or pericardial disease.","[{'ForeName': 'Justin E', 'Initials': 'JE', 'LastName': 'Bekelman', 'Affiliation': 'Department of Radiation Oncology, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA bekelman@upenn.edu.'}, {'ForeName': 'Hien', 'Initials': 'H', 'LastName': 'Lu', 'Affiliation': 'Department of Radiation Oncology, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Pugh', 'Affiliation': 'American College of Radiology, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Kaysee', 'Initials': 'K', 'LastName': 'Baker', 'Affiliation': 'Department of Radiation Oncology, University of Maryland School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Christine D', 'Initials': 'CD', 'LastName': 'Berg', 'Affiliation': 'Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Amy Berrington', 'Initials': 'AB', 'LastName': 'de Gonzalez', 'Affiliation': 'Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Lior Z', 'Initials': 'LZ', 'LastName': 'Braunstein', 'Affiliation': 'Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York city, New York, USA.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Bosch', 'Affiliation': 'Department of Radiation Oncology, Washington University in St. Louis, St. Louis, Missouri, USA.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Chauhan', 'Affiliation': 'Mayo Clinic Minnesota, Rochester, Minnesota, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Ellenberg', 'Affiliation': 'Department of Biostatistics, Epidemiology and Informatics, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'L Christine', 'Initials': 'LC', 'LastName': 'Fang', 'Affiliation': 'Department of Radiation Oncology, University of Washington School of Medicine, Seattle, Washington, USA.'}, {'ForeName': 'Gary M', 'Initials': 'GM', 'LastName': 'Freedman', 'Affiliation': 'Department of Radiation Oncology, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Hahn', 'Affiliation': 'Department of Medical Social Sciences, Northwestern University, Evanston, Illinois, USA.'}, {'ForeName': 'B G', 'Initials': 'BG', 'LastName': 'Haffty', 'Affiliation': 'Department of Radiation Oncology, Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, USA.'}, {'ForeName': 'Atif J', 'Initials': 'AJ', 'LastName': 'Khan', 'Affiliation': 'Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York city, New York, USA.'}, {'ForeName': 'Rachel B', 'Initials': 'RB', 'LastName': 'Jimenez', 'Affiliation': 'Department of Radiation Oncology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Christy', 'Initials': 'C', 'LastName': 'Kesslering', 'Affiliation': 'Northwestern Medicine Chicago Proton Center, Warrenville, Illinois, USA.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Ky', 'Affiliation': 'Cardio-Oncology Program, Division of Cardiovascular Medicine, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Choonsik', 'Initials': 'C', 'LastName': 'Lee', 'Affiliation': 'Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Hsiao-Ming', 'Initials': 'HM', 'LastName': 'Lu', 'Affiliation': 'Department of Radiation Oncology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Mark V', 'Initials': 'MV', 'LastName': 'Mishra', 'Affiliation': 'Department of Radiation Oncology, University of Maryland School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'C Daniel', 'Initials': 'CD', 'LastName': 'Mullins', 'Affiliation': 'PHSR, University of Maryland School of Pharmacy, Baltimore, Maryland, USA.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Mutter', 'Affiliation': 'Department of Radiation Oncology, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Suneel', 'Initials': 'S', 'LastName': 'Nagda', 'Affiliation': 'Department of Radiation Oncology, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Pankuch', 'Affiliation': 'Northwestern Medicine Chicago Proton Center, Warrenville, Illinois, USA.'}, {'ForeName': 'Simon N', 'Initials': 'SN', 'LastName': 'Powell', 'Affiliation': 'Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York city, New York, USA.'}, {'ForeName': 'Fred W', 'Initials': 'FW', 'LastName': 'Prior', 'Affiliation': 'Department of Biomedical Informatics, University of Arkansas for Medical Sciences, Little Rock, Arkansas, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Schupak', 'Affiliation': 'Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York city, New York, USA.'}, {'ForeName': 'Alphonse G', 'Initials': 'AG', 'LastName': 'Taghian', 'Affiliation': 'Department of Radiation Oncology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'J Ben', 'Initials': 'JB', 'LastName': 'Wilkinson', 'Affiliation': 'Provision Proton Therapy Center, Knoxville, Tennessee, USA.'}, {'ForeName': 'Shannon M', 'Initials': 'SM', 'LastName': 'MacDonald', 'Affiliation': 'Department of Radiation Oncology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Oren', 'Initials': 'O', 'LastName': 'Cahlon', 'Affiliation': 'Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York city, New York, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2018-025556']
468,31825248,Single-Dose Euglycemic Clamp Study Demonstrating Pharmacokinetic and Pharmacodynamic Similarity Between SAR341402 Insulin Aspart and US- and EU-Approved Versions of Insulin Aspart in Subjects with Type 1 Diabetes.,"Background:  The objective of this study was to demonstrate the pharmacokinetic and pharmacodynamic similarity among SAR341402 insulin aspart biosimilar/follow-on product, United States-sourced insulin aspart (NovoLog ® ), and European Union-sourced insulin aspart (NovoRapid ® ).  Materials and Methods:  This was a single-center, randomized, double-blind, 3-treatment, 3-period, single-dose, crossover euglycemic study (NCT03202875) in 30 adult male subjects with type 1 diabetes (T1D). Subjects received 0.3 U/kg of each treatment under fasted conditions and underwent a 12-h euglycemic clamp technique to assess pharmacokinetic and pharmacodynamic activity for up to 12 h. Primary endpoints were area under the plasma insulin concentration-time curve from time zero to the last quantifiable concentration (INS-AUC last ), and extrapolated to infinity (INS-AUC inf ), maximum plasma insulin concentration (INS-C max ), and the area under the body weight-standardized glucose infusion rate (GIR)-time curve from 0 to 12 hours (GIR-AUC 0-12h ) among the three treatments. GIR max  was the main secondary endpoint.  Results:  Of the 30 subjects randomized, 29 completed all 3 treatment periods. Pharmacokinetic and pharmacodynamic profiles were similar in all groups. The extent of exposure (INS-C max , INS-AUC last , and INS-AUC inf ) and glucodynamic activity (GIR-AUC 0-12h , GIR max ) was similar among the three treatments. The corresponding 90% confidence intervals for pairwise treatment ratios were completely contained within the limits of 80%-125%. SAR341402 was well tolerated.  Conclusions:  The present study demonstrated similar pharmacokinetic exposure profiles and glucodynamic potency among SAR341402, NovoLog, and NovoRapid in subjects with T1D, supporting further clinical evaluation of SAR341402 as a biosimilar/follow-on product.",2020,Pharmacokinetic and pharmacodynamic profiles were similar in all groups.,"['30 adult male subjects with type 1 diabetes (T1D', '30 subjects randomized, 29 completed all 3 treatment periods', 'subjects with T1D', 'Subjects with Type 1 Diabetes']","['euglycemic clamp technique', 'SAR341402 Insulin Aspart and US- and EU-Approved Versions of Insulin Aspart', 'SAR341402 insulin aspart biosimilar/follow-on product, United States-sourced insulin aspart (NovoLog ® ), and European Union-sourced insulin aspart (NovoRapid ® ']","['plasma insulin concentration-time curve from time zero to the last quantifiable concentration (INS-AUC last ), and extrapolated to infinity (INS-AUC inf ), maximum plasma insulin concentration (INS-C max ), and the area under the body weight-standardized glucose infusion rate (GIR)-time curve', 'Pharmacokinetic and pharmacodynamic profiles', 'extent of exposure (INS-C max , INS-AUC last , and INS-AUC inf ) and glucodynamic activity (GIR-AUC 0-12h , GIR max ', 'pharmacokinetic and pharmacodynamic activity', 'tolerated']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0079318', 'cui_str': 'Glucose Clamp'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0123677', 'cui_str': 'Insulin, Aspart, Human'}, {'cui': 'C0205540', 'cui_str': 'Approved (qualifier value)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C4045974', 'cui_str': 'Biosimilars'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C4521696', 'cui_str': 'Source (property)'}, {'cui': 'C0939412', 'cui_str': 'NovoLog'}, {'cui': 'C0015179', 'cui_str': 'European Community'}]","[{'cui': 'C0857690', 'cui_str': 'Plasma insulin'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0919414', 'cui_str': '0 (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0439792', 'cui_str': 'Extents (qualifier value)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",29.0,0.0795618,Pharmacokinetic and pharmacodynamic profiles were similar in all groups.,"[{'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Kapitza', 'Affiliation': 'Profil Institut für Stoffwechselforschung GmbH, Neuss, Germany.'}, {'ForeName': 'Leszek', 'Initials': 'L', 'LastName': 'Nosek', 'Affiliation': 'Profil Institut für Stoffwechselforschung GmbH, Neuss, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Schmider', 'Affiliation': 'Sanofi-Aventis Deutschland GmbH, Frankfurt, Germany.'}, {'ForeName': 'Lenore', 'Initials': 'L', 'LastName': 'Teichert', 'Affiliation': 'Sanofi-Aventis Deutschland GmbH, Frankfurt, Germany.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Nowotny', 'Affiliation': 'Sanofi-Aventis Deutschland GmbH, Frankfurt, Germany.'}]",Diabetes technology & therapeutics,['10.1089/dia.2019.0351']
469,31254639,Minocycline for Symptom Reduction During Oxaliplatin-Based Chemotherapy for Colorectal Cancer: A Phase II Randomized Clinical Trial.,"CONTEXT


The most debilitating symptoms during oxaliplatin-based chemotherapy in patients with colorectal cancer (CRC) are neuropathy and fatigue. Inflammation has been suggested to contribute to these symptoms, and the anti-inflammatory agent minocycline is safe and readily available.
OBJECTIVES


This proof-of-concept study investigated minocycline's capacity to reduce treatment-related neuropathy and fatigue and its impact on inflammatory markers during chemotherapy in a Phase II randomized, double-blind, placebo-controlled clinical trial.
METHODS


Patients with locally advanced or metastatic CRC who were scheduled for oxaliplatin-based chemotherapy were randomly assigned to receive either minocycline (100 mg twice daily) or placebo over four months from started chemotherapy. Toxicity assessments and blood samples were prospectively collected monthly. The severity of fatigue and numbness/tingling was assessed weekly using the MD Anderson Symptom Inventory. The primary endpoint, area under the curve for numbness/tingling and fatigue over approximately four months, was compared between the two arms.
RESULTS


Of 66 evaluable participants, 32 received minocycline and 34 placebo. There was no observed significant symptom reduction on both fatigue and numbness/tingling in either arm, nor was there a difference in levels of serum proinflammatory and anti-inflammatory markers between arms. No Grade 3 adverse events nor disparity mediating effects on intervention were observed.
CONCLUSION


Minocycline treatment is feasible and has a low-toxicity profile. However, with 200 mg/day, it did not reduce numbness/tingling or fatigue nor moderate inflammatory biomarkers from this Phase II randomized study. Our results do not support further exploration of minocycline for fatigue or neuropathy symptom intervention in patients treated for CRC.",2019,"However, with 200mg/day, it did not reduce numbness/tingling or fatigue nor moderate inflammatory biomarkers from this phase II randomized study.","['patients with colorectal cancer (CRC', '66 evaluable participants', 'patients been treated with CRC', 'Patients with locally advanced or metastatic CRC who were scheduled for', 'Colorectal Cancer']","['Minocycline', 'placebo', 'Oxaliplatin-Based Chemotherapy', 'oxaliplatin-based chemotherapy', 'minocycline and 34 placebo', 'minocycline']","['levels of serum pro-inflammatory and anti-inflammatory markers', 'fatigue and numbness/tingling', 'area under the curve for numbness/tingling and fatigue', 'numbness/tingling or fatigue nor moderate inflammatory biomarkers', 'severity of fatigue and numbness/tingling', 'Toxicity assessments and blood samples']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0170127', 'cui_str': 'Calcibiotic Root Canal Sealer'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}]","[{'cui': 'C0026187', 'cui_str': 'Minocycline'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0020580', 'cui_str': 'Reduced Sensation'}, {'cui': 'C2242996', 'cui_str': 'Tingling'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}]",,0.145897,"However, with 200mg/day, it did not reduce numbness/tingling or fatigue nor moderate inflammatory biomarkers from this phase II randomized study.","[{'ForeName': 'Xin Shelley', 'Initials': 'XS', 'LastName': 'Wang', 'Affiliation': 'Department of Symptom Research, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA. Electronic address: xswang@mdanderson.org.'}, {'ForeName': 'Qiuling', 'Initials': 'Q', 'LastName': 'Shi', 'Affiliation': 'Department of Symptom Research, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Nishin A', 'Initials': 'NA', 'LastName': 'Bhadkamkar', 'Affiliation': 'Department of General Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Charles S', 'Initials': 'CS', 'LastName': 'Cleeland', 'Affiliation': 'Department of Symptom Research, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Araceli', 'Initials': 'A', 'LastName': 'Garcia-Gonzalez', 'Affiliation': 'Department of Symptom Research, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Jonathan R', 'Initials': 'JR', 'LastName': 'Aguilar', 'Affiliation': 'Office of Protocol Support and Management, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Cobi', 'Initials': 'C', 'LastName': 'Heijnen', 'Affiliation': 'Department of Symptom Research, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Eng', 'Affiliation': 'Department of GI Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2019.06.018']
470,31254640,Additive Duloxetine for Cancer-Related Neuropathic Pain Nonresponsive or Intolerant to Opioid-Pregabalin Therapy: A Randomized Controlled Trial (JORTC-PAL08).,"CONTEXT


Although opioids and pregabalin are widely used for cancer-related neuropathic pain (CNP), no clinical trials exist to determine which medications are effective when an opioid-pregabalin combination therapy fails.
OBJECTIVES


We investigated the efficacy of duloxetine for CNP nonresponsive or intolerant to opioid-pregabalin combination therapy.
METHODS


A multicenter, randomized, double-blind, placebo-controlled trial was performed at 12 specialized palliative care services in Japan. Patients with CNP average pain scores (Brief Pain Inventory [BPI]-Item 5) ≥ 4 in the previous 24 hours and nonresponsive or intolerant to opioid-pregabalin combination therapy were eligible. Patients with chemotherapy-induced peripheral neuropathies were excluded. Patients were administered duloxetine 20 mg/day titrated to 40 mg/day or placebo for 10 days. The primary endpoint was BPI-Item 5 on Day 10. Responder analysis measured proportions of patients with 30% and 50% pain decreases.
RESULTS


Seventy patients were enrolled. Complete case analysis revealed mean BPI-Item 5 on Day 10 of 4.03 for Group D vs. 4.88 for Group P (P = 0.053). Baseline observation carried forward analysis revealed mean BPI-Item 5 on Day 10 of 4.06 and 4.91 for Groups D and P, respectively (P = 0.048). Clinically meaningful pain improvement (≥30%) was reported by 44.1% (n = 15) of patients in Group D vs. 18.2% (n = 6) in Group P (P = 0.02); 32.4% (n = 11) vs. 3.0% (n = 1) of patients in Groups D and P, respectively, reported pain reduction ≥ 50% (P = 0.002).
CONCLUSION


Adding duloxetine to opioid-pregabalin therapy might have clinical benefit in alleviating refractory CNP. Further studies are needed to conclude the efficacy of adding duloxetine.",2019,"Clinically meaningful pain improvement (≥ 30%) was reported by 44.1% (n = 15) of patients in group D vs. 18.2% (n = 6) in group P (p＝.02); 32.4% (n = 11) vs. 3.0% (n = 1) of patients in groups D and P, respectively, reported pain reduction ≥ 50% (p＝.002).
","['Cancer-related Neuropathic Pain Nonresponsive or Intolerant to Opioid-Pregabalin Therapy', 'Seventy patients were enrolled', 'Patients with CNP average pain scores (BPI-item 5) ≥ 4 in the previous 24 h, and nonresponsive or intolerant to opioid- pregabalin combination therapy were eligible', 'Patients with chemotherapy-induced peripheral neuropathies', '12 specialized palliative care services in Japan']","['opioids and pregabalin', 'placebo', 'Additive Duloxetine', 'duloxetine 20 mg/d titrated to 40 mg/d or placebo', 'duloxetine']","['Clinically meaningful pain improvement', 'BPI-Item', 'mean BPI-Item']","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0027796', 'cui_str': 'Neurodynia'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0657912', 'cui_str': 'pregabalin'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}, {'cui': 'C3873567', 'cui_str': 'Peripheral neuropathy due to and following chemotherapy'}, {'cui': 'C1704211', 'cui_str': 'Specialized'}, {'cui': 'C0587605', 'cui_str': 'Palliative care service (qualifier value)'}, {'cui': 'C0022341', 'cui_str': 'Japan'}]","[{'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0657912', 'cui_str': 'pregabalin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0442796', 'cui_str': 'Additive (qualifier value)'}, {'cui': 'C0245561', 'cui_str': 'duloxetine'}, {'cui': 'C1617011', 'cui_str': 'duloxetine 20 MG [Cymbalta]'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",70.0,0.379863,"Clinically meaningful pain improvement (≥ 30%) was reported by 44.1% (n = 15) of patients in group D vs. 18.2% (n = 6) in group P (p＝.02); 32.4% (n = 11) vs. 3.0% (n = 1) of patients in groups D and P, respectively, reported pain reduction ≥ 50% (p＝.002).
","[{'ForeName': 'Hiromichi', 'Initials': 'H', 'LastName': 'Matsuoka', 'Affiliation': 'Improving Palliative, Aged and Chronic Care through Clinical Research and Translation (IMPACCT) and Palliative Care Clinical Studies Collaborative (PaCCSC), University of Technology Sydney, Sydney, Australia; Department of Psychosomatic Medicine, Kindai University Faculty of Medicine, Osaka, Japan. Electronic address: matsuoka_h@med.kindai.ac.jp.'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Iwase', 'Affiliation': 'Department of Palliative Medicine, University of Saitama Medical University, Saitama, Japan.'}, {'ForeName': 'Tempei', 'Initials': 'T', 'LastName': 'Miyaji', 'Affiliation': 'Department of Clinical Trial Data Management, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Kawaguchi', 'Affiliation': 'Department of Practical Pharmacy, Tokyo University of Pharmacy and Life Sciences, Tokyo, Japan.'}, {'ForeName': 'Keisuke', 'Initials': 'K', 'LastName': 'Ariyoshi', 'Affiliation': 'Japanese Organization for Research and Treatment of Cancer (JORTC), JORTC Data Center, Tokyo, Japan.'}, {'ForeName': 'Shunsuke', 'Initials': 'S', 'LastName': 'Oyamada', 'Affiliation': 'Japanese Organization for Research and Treatment of Cancer (JORTC), JORTC Data Center, Tokyo, Japan.'}, {'ForeName': 'Eriko', 'Initials': 'E', 'LastName': 'Satomi', 'Affiliation': 'Department of Palliative Medicine, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Hiroto', 'Initials': 'H', 'LastName': 'Ishiki', 'Affiliation': 'Department of Palliative Medicine, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Hasuo', 'Affiliation': 'Department of Psychosomatic Internal Medicine, Kansai Medical University, Osaka, Japan.'}, {'ForeName': 'Hiroko', 'Initials': 'H', 'LastName': 'Sakuma', 'Affiliation': 'Department of Psychosomatic Internal Medicine, Kansai Medical University, Osaka, Japan.'}, {'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Tokoro', 'Affiliation': 'Department of Psychosomatic Internal Medicine, National Hospital Organization Kinki-Chuo Chest Medical Center, Sakai, Japan.'}, {'ForeName': 'Toshiaki', 'Initials': 'T', 'LastName': 'Shinomiya', 'Affiliation': 'Department of Palliative Medicine, Nara Medical University, Kashihara, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Otani', 'Affiliation': 'Department of Palliative Medicine, National Kyushu Cancer Center, Fukuoka, Japan.'}, {'ForeName': 'Yoichi', 'Initials': 'Y', 'LastName': 'Ohtake', 'Affiliation': 'Department of Psychosomatic Internal Medicine and Palliative Care, Sakai City Medical Center, Sakai, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Tsukuura', 'Affiliation': 'Department of Medical Oncology, Nagoya University Hospital, Aichi, Japan.'}, {'ForeName': 'Yoshihisa', 'Initials': 'Y', 'LastName': 'Matsumoto', 'Affiliation': 'Department of Palliative Medicine, National Cancer Center East, Kashiwa, Japan.'}, {'ForeName': 'Yoshikazu', 'Initials': 'Y', 'LastName': 'Hasegawa', 'Affiliation': 'Department of Medical Oncology, Izumi City General Hospital, Izumi, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Kataoka', 'Affiliation': 'Department of Respiratory Medicine, Hyogo Prefectural Amagasaki General Medical Center, Hyogo, Japan.'}, {'ForeName': 'Masatomo', 'Initials': 'M', 'LastName': 'Otsuka', 'Affiliation': 'Department of Palliative Medicine, Kindai University Nara Hospital, Nara, Japan.'}, {'ForeName': 'Kiyohiro', 'Initials': 'K', 'LastName': 'Sakai', 'Affiliation': 'Department of Psychosomatic Medicine, Kindai University Faculty of Medicine, Osaka, Japan.'}, {'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Matsuda', 'Affiliation': 'Department of Psychosomatic Internal Medicine, National Hospital Organization Kinki-Chuo Chest Medical Center, Sakai, Japan.'}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Morita', 'Affiliation': 'Palliative and Supportive Care Division, Seirei Mikatahara General Hospital, Hamamatsu, Japan.'}, {'ForeName': 'Atsuko', 'Initials': 'A', 'LastName': 'Koyama', 'Affiliation': 'Department of Psychosomatic Medicine, Kindai University Faculty of Medicine, Osaka, Japan.'}, {'ForeName': 'Takuhiro', 'Initials': 'T', 'LastName': 'Yamaguchi', 'Affiliation': 'Division of Biostatistics, Tohoku University Graduate School of Medicine, Sendai, Japan.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2019.06.020']
471,31255586,Acceptance and Commitment Therapy for Symptom Interference in Advanced Lung Cancer and Caregiver Distress: A Pilot Randomized Trial.,"CONTEXT


Advanced lung cancer patients typically have a poor prognosis and many symptoms that interfere with functioning, contributing to high rates of emotional distress in both patients and family caregivers. There remains a need for evidence-based interventions to improve functional outcomes and distress in this population.
OBJECTIVES


This pilot trial examined the feasibility and preliminary efficacy of telephone-based Acceptance and Commitment Therapy (ACT) for symptomatic, advanced lung cancer patients and their distressed family caregivers. Primary outcomes were patient symptom interference with functioning and patient and caregiver distress.
METHODS


Symptomatic, advanced lung cancer patients and distressed caregivers (n = 50 dyads) were randomly assigned to six sessions of ACT or an education/support condition. Patients completed measures of symptom interference and measures assessing the severity of fatigue, pain, sleep disturbance, and breathlessness. Patients and caregivers completed measures of distress and illness acceptance and struggle.
RESULTS


The eligibility screening rate (51%) and retention rate (76% at six weeks postintervention) demonstrated feasibility. No group differences were found with respect to patient and caregiver outcomes. Both groups showed a small, significant decrease in struggle with the illness over the study period, but did not show meaningful change in other outcomes.
CONCLUSION


Findings suggest that telephone-based ACT is feasible for many advanced lung cancer patients and caregivers, but may not substantially reduce symptom interference and distress. Low baseline levels of certain symptoms may have contributed to null findings. Next steps include applying ACT to specific, clinically meaningful symptom interference and varying intervention dose and modality.",2019,The eligibility screening rate (51%) and retention rate (76% at 6 weeks post-intervention) demonstrated feasibility.,"['symptomatic, advanced lung cancer patients and their distressed family caregivers', 'advanced lung cancer patients and caregivers', 'Advanced lung cancer patients', 'Symptomatic, advanced lung cancer patients and distressed caregivers (n=50 dyads', 'Advanced Lung Cancer and Caregiver Distress']","['Acceptance and Commitment Therapy', 'telephone-based ACT', 'ACT or an education/support condition', 'telephone-based Acceptance and Commitment Therapy (ACT']","['symptom interference and measures assessing the severity of fatigue, pain, sleep disturbance, and breathlessness', 'distress and illness acceptance and struggle', 'patient symptom interference with functioning and patient and caregiver distress', 'eligibility screening rate', 'retention rate']","[{'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C4524268', 'cui_str': 'Advanced lung cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}]","[{'cui': 'C3658321', 'cui_str': 'Acceptance and Commitment Therapy'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnias'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0035280', 'cui_str': 'Retention'}]",,0.097103,The eligibility screening rate (51%) and retention rate (76% at 6 weeks post-intervention) demonstrated feasibility.,"[{'ForeName': 'Catherine E', 'Initials': 'CE', 'LastName': 'Mosher', 'Affiliation': 'Department of Psychology, Indiana University-Purdue University Indianapolis, Indianapolis, Indiana, USA. Electronic address: cemosher@iupui.edu.'}, {'ForeName': 'Ekin', 'Initials': 'E', 'LastName': 'Secinti', 'Affiliation': 'Department of Psychology, Indiana University-Purdue University Indianapolis, Indianapolis, Indiana, USA.'}, {'ForeName': 'Adam T', 'Initials': 'AT', 'LastName': 'Hirsh', 'Affiliation': 'Department of Psychology, Indiana University-Purdue University Indianapolis, Indianapolis, Indiana, USA.'}, {'ForeName': 'Nasser', 'Initials': 'N', 'LastName': 'Hanna', 'Affiliation': 'Department of Medicine, Indiana University School of Medicine, Indianapolis, Indiana, USA.'}, {'ForeName': 'Lawrence H', 'Initials': 'LH', 'LastName': 'Einhorn', 'Affiliation': 'Department of Medicine, Indiana University School of Medicine, Indianapolis, Indiana, USA.'}, {'ForeName': 'Shadia I', 'Initials': 'SI', 'LastName': 'Jalal', 'Affiliation': 'Department of Medicine, Indiana University School of Medicine, Indianapolis, Indiana, USA; Richard L. Roudebush VAMC, Indianapolis, Indiana, USA.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Durm', 'Affiliation': 'Department of Medicine, Indiana University School of Medicine, Indianapolis, Indiana, USA.'}, {'ForeName': 'Victoria L', 'Initials': 'VL', 'LastName': 'Champion', 'Affiliation': 'Indiana University School of Nursing, Indianapolis, Indiana, USA.'}, {'ForeName': 'Shelley A', 'Initials': 'SA', 'LastName': 'Johns', 'Affiliation': 'Indiana University School of Medicine, Center for Health Services Research, Regenstrief Institute, Indianapolis, Indiana, USA.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2019.06.021']
472,31601606,Randomised controlled pilot feasibility trial of an early intervention programme for young infants with neurodevelopmental impairment in Uganda: a study protocol.,"INTRODUCTION


Early intervention programmes (EIPs) for infants with neurodevelopmental impairment have been poorly studied especially in low-income settings. We aim to evaluate the feasibility and acceptability of a group participatory EIP, the 'ABAaNA EIP', for young children with neurodevelopmental impairment in Uganda.
METHODS AND ANALYSIS


We will conduct a pilot feasibility, single-blinded, randomised controlled trial comparing the EIP with standard care across two study sites (one urban, one rural) in central Uganda. Eligible infants (n=126, age 6-11 completed months) with neurodevelopmental impairment (defined as a developmental quotient <70 on Griffiths Scales of Mental Development, and, or Hammersmith Infant Neurological Examination score <60) will be recruited and randomised to the intervention or standard care arm. Intervention arm families will receive the 10-modular, peer-facilitated, participatory, community-based programme over 6 months. Recruited families will be followed up at 6 and 12 months after recruitment, and assessors will be blinded to the trial allocation. The primary hypothesis is that the ABAaNA EIP is feasible and acceptable when compared with standard care. Primary outcomes of interest are feasibility (number recruited and randomised at baseline) and acceptability (protocol violation of arm allocation and number of sessions attended) and family and child quality of life. Guided by the study aim, the qualitative data analysis will use a data-led thematic framework approach. The findings will inform scalability and sustainability of the programme.
ETHICS AND DISSEMINATION


The trial protocol has been approved by the relevant Ugandan and UK ethics committees. Recruited families will give written informed consent and we will follow international codes for ethics and good clinical practice. Dissemination will be through peer-reviewed publications, conference presentations and public engagement.
TRIAL REGISTRATION NUMBER


ISRCTN44380971; protocol version 3.0, 19th February 2018.",2019,"We aim to evaluate the feasibility and acceptability of a group participatory EIP, the 'ABAaNA EIP', for young children with neurodevelopmental impairment in Uganda.
","['young children with neurodevelopmental impairment in Uganda', 'young infants with neurodevelopmental impairment in Uganda', 'Eligible infants (n=126, age 6-11 completed months) with neurodevelopmental impairment (defined as a developmental quotient <70 on Griffiths Scales of Mental Development, and, or Hammersmith Infant Neurological Examination score <60', 'infants with neurodevelopmental impairment', 'EIP with standard care across two study sites (one urban, one rural) in central Uganda']","['ABAaNA', 'early intervention programme']","['acceptability (protocol violation of arm allocation and number of sessions attended) and family and child quality of life', 'feasibility and acceptability']","[{'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0458003', 'cui_str': 'Developmental (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0335933', 'cui_str': 'Hammersmith (occupation)'}, {'cui': 'C0027853', 'cui_str': 'Neurological Examination'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0242687', 'cui_str': 'Early Intervention'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0034380'}]",11.0,0.166118,"We aim to evaluate the feasibility and acceptability of a group participatory EIP, the 'ABAaNA EIP', for young children with neurodevelopmental impairment in Uganda.
","[{'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Nampijja', 'Affiliation': 'Social Aspects of Health Programme, MRC/UVRI & LSHTM Uganda Research Unit, Entebbe, Uganda.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Webb', 'Affiliation': 'MRC Tropical Epidemiology Group, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Nanyunja', 'Affiliation': 'Social Aspects of Health Programme, MRC/UVRI & LSHTM Uganda Research Unit, Entebbe, Uganda.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Sadoo', 'Affiliation': 'Department of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Nalugya', 'Affiliation': 'Social Aspects of Health Programme, MRC/UVRI & LSHTM Uganda Research Unit, Entebbe, Uganda.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Nyonyintono', 'Affiliation': 'Adara Development, Washington, United Kingdom.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Muhumuza', 'Affiliation': 'Neonatal Medicine, Mulago National Referral Hospital, Kampala, Uganda.'}, {'ForeName': 'Moses', 'Initials': 'M', 'LastName': 'Ssekidde', 'Affiliation': 'Kiwoko Hospital, Nakaseke, Uganda.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Katumba', 'Affiliation': 'Social Aspects of Health Programme, MRC/UVRI & LSHTM Uganda Research Unit, Entebbe, Uganda.'}, {'ForeName': 'Brooke', 'Initials': 'B', 'LastName': 'Magnusson', 'Affiliation': 'Adara Development, Washington, United Kingdom.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Kabugo', 'Affiliation': 'Adara Development, Washington, United Kingdom.'}, {'ForeName': 'Frances M', 'Initials': 'FM', 'LastName': 'Cowan', 'Affiliation': 'Department of Paediatrics, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Martinez-Biarge', 'Affiliation': 'Department of Paediatrics, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Zuurmond', 'Affiliation': 'Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Morgan', 'Affiliation': 'Cerebral Palsy Alliance Research Institute, Sydney, New South Wales, Australia.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Lester', 'Affiliation': 'Adara Development, Washington, United Kingdom.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Seeley', 'Affiliation': 'Social Aspects of Health Programme, MRC/UVRI & LSHTM Uganda Research Unit, Entebbe, Uganda.'}, {'ForeName': 'Cally J', 'Initials': 'CJ', 'LastName': 'Tann', 'Affiliation': 'Social Aspects of Health Programme, MRC/UVRI & LSHTM Uganda Research Unit, Entebbe, Uganda Cally.Tann@lshtm.ac.uk.'}]",BMJ open,['10.1136/bmjopen-2019-032705']
473,31738372,Minocycline at 2 Different Dosages vs Placebo for Patients With Mild Alzheimer Disease: A Randomized Clinical Trial.,"Importance


There are no disease-modifying treatments for Alzheimer disease (AD), the most common cause of dementia. Minocycline is anti-inflammatory, protects against the toxic effects of β-amyloid in vitro and in animal models of AD, and is a credible repurposed treatment candidate.
Objective


To determine whether 24 months of minocycline treatment can modify cognitive and functional decline in patients with mild AD.
Design, Setting, and Participants


Participants were recruited into a double-blind randomized clinical trial from May 23, 2014, to April 14, 2016, with 24 months of treatment and follow-up. This multicenter study in England and Scotland involved 32 National Health Service memory clinics within secondary specialist services for people with dementia. From 886 screened patients, 554 patients with a diagnosis of mild AD (Standardised Mini-Mental State Examination [sMMSE] score ≥24) were randomized.
Interventions


Participants were randomly allocated 1:1:1 in a semifactorial design to receive minocycline (400 mg/d or 200 mg/d) or placebo for 24 months.
Main Outcomes and Measures


Primary outcome measures were decrease in sMMSE score and Bristol Activities of Daily Living Scale (BADLS), analyzed by intention-to-treat repeated-measures regression.
Results


Of 544 eligible participants (241 women and 303 men), the mean (SD) age was 74.3 (8.2) years, and the mean (SD) sMMSE score was 26.4 (1.9). Fewer participants completed 400-mg minocycline hydrochloride treatment (28.8% [53 of 184]) than 200-mg minocycline treatment (61.9% [112 of 181]) or placebo (63.7% [114 of 179]; P < .001), mainly because of gastrointestinal symptoms (42 in the 400-mg group, 15 in the 200-mg group, and 10 in the placebo group; P < .001), dermatologic adverse effects (10 in the 400-mg group, 5 in the 200-mg group, and 1 in the placebo group; P = .02), and dizziness (14 in the 400-mg group, 3 in the 200-mg group, and 1 in the placebo group; P = .01). Assessment rates were lower in the 400-mg group: 68.4% (119 of 174 expected) for sMMSE at 24 months compared with 81.8% (144 of 176) for the 200-mg group and 83.8% (140 of 167) for the placebo group. Decrease in sMMSE scores over 24 months in the combined minocycline group was similar to that in the placebo group (4.1 vs 4.3 points). The combined minocycline group had mean sMMSE scores 0.1 points higher than the placebo group (95% CI, -1.1 to 1.2; P = .90). The decrease in mean sMMSE scores was less in the 400-mg group than in the 200-mg group (3.3 vs 4.7 points; treatment effect = 1.2; 95% CI, -0.1 to 2.5; P = .08). Worsening of BADLS scores over 24 months was similar in all groups: 5.7 in the 400-mg group, 6.6 in the 200-mg group, and 6.2 in the placebo groups (treatment effect for minocycline vs placebo = -0.53; 95% CI, -2.4 to 1.3; P = .57; treatment effect for 400 mg vs 200 mg of minocycline = -0.31; 95% CI, -0.2 to 1.8; P = .77). Results were similar in different patient subgroups and in sensitivity analyses adjusting for missing data.
Conclusions and Relevance


Minocycline did not delay the progress of cognitive or functional impairment in people with mild AD during a 2-year period. This study also found that 400 mg of minocycline is poorly tolerated in this population.
Trial Registration


isrctn.org Identifier: ISRCTN16105064.",2020,"Minocycline is anti-inflammatory, protects against the toxic effects of β-amyloid in vitro and in animal models of AD, and is a credible repurposed treatment candidate.
","['544 eligible participants (241 women and 303 men', 'patients with mild AD', 'Patients With Mild Alzheimer Disease', '32 National Health Service memory clinics within secondary specialist services for people with dementia', '886 screened patients, 554 patients with a diagnosis of mild AD (Standardised Mini-Mental State Examination [sMMSE] score ≥24) were randomized']","['Placebo', 'minocycline hydrochloride', 'placebo', 'minocycline', 'Minocycline']","['Assessment rates', 'gastrointestinal symptoms', 'sMMSE scores', 'dermatologic adverse effects', 'cognitive and functional decline', 'Worsening of BADLS scores', 'mean sMMSE scores', 'sMMSE score and Bristol Activities of Daily Living Scale (BADLS), analyzed by intention-to-treat repeated-measures regression', 'mean (SD) sMMSE score', 'dizziness']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0027462', 'cui_str': 'Health Services, National'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C2960235', 'cui_str': 'Mini-mental state examination score (observable entity)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0026186', 'cui_str': 'Minocycline Hydrochloride'}, {'cui': 'C0026187', 'cui_str': 'Minocycline'}]","[{'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205489', 'cui_str': 'Dermatologic (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0222045'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0684321', 'cui_str': 'Regression'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}]",554.0,0.722529,"Minocycline is anti-inflammatory, protects against the toxic effects of β-amyloid in vitro and in animal models of AD, and is a credible repurposed treatment candidate.
","[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Howard', 'Affiliation': 'Division of Psychiatry, University College London, London, United Kingdom.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Zubko', 'Affiliation': ""Old Age Psychiatry, King's College London, London, United Kingdom.""}, {'ForeName': 'Rosie', 'Initials': 'R', 'LastName': 'Bradley', 'Affiliation': 'Medical Research Council Population Health Research Unit, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Harper', 'Affiliation': 'Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Pank', 'Affiliation': 'Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': ""O'Brien"", 'Affiliation': 'Department of Psychiatry, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Fox', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, United Kingdom.'}, {'ForeName': 'Naji', 'Initials': 'N', 'LastName': 'Tabet', 'Affiliation': 'Department of Old Age Psychiatry, University of Sussex, Brighton, United Kingdom.'}, {'ForeName': 'Gill', 'Initials': 'G', 'LastName': 'Livingston', 'Affiliation': 'Division of Psychiatry, University College London, London, United Kingdom.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bentham', 'Affiliation': 'Birmingham and Solihull Mental Health National Health Service Foundation Trust, Birmingham, United Kingdom.'}, {'ForeName': 'Rupert', 'Initials': 'R', 'LastName': 'McShane', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Alistair', 'Initials': 'A', 'LastName': 'Burns', 'Affiliation': 'Department of Old Age Psychiatry, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Ritchie', 'Affiliation': 'Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Reeves', 'Affiliation': 'Division of Psychiatry, University College London, London, United Kingdom.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Lovestone', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Clive', 'Initials': 'C', 'LastName': 'Ballard', 'Affiliation': 'Medical School, University of Exeter, Exeter, United Kingdom.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Noble', 'Affiliation': ""Department of Basic and Clinical Neuroscience, King's College London, London, United Kingdom.""}, {'ForeName': 'Ramin', 'Initials': 'R', 'LastName': 'Nilforooshan', 'Affiliation': 'Surrey and Borders Partnership National Health Service Foundation Trust, United Kingdom.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Wilcock', 'Affiliation': 'Department of Clinical Neurosciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Gray', 'Affiliation': 'Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA neurology,['10.1001/jamaneurol.2019.3762']
474,31006399,Point-of-care ultrasound before attempting clean-catch urine collection in infants: a randomized controlled trial.,"OBJECTIVE


A new non-invasive bladder stimulation technique has been described to obtain clean-catch urine specimens in infants. This study aimed to evaluate if point-of-care ultrasound (POCUS) guided feeding protocol to measure bladder volume prior to stimulation techniques improves clean-catch urine collection success.
METHODS


A prospective randomized controlled trial study was conducted in a tertiary care pediatric emergency department. Infants aged less than 6 months needing a urine sample were randomized to either POCUS group or feeding group (standard procedure) before performing a standardized clean-catch urine stimulation technique. In the POCUS group, a feeding period was permitted if the bladder width was less than 2 cm, otherwise the clean-catch urine was performed immediately. The primary outcome was the success of the procedure defined by the collection of at least 2 mL of urine, obtained within 300 seconds of bladder stimulation manoeuvres. It was estimated that the recruitment of 200 children was necessary to yield 80% power to identify an improvement of 20% in the success rate.
RESULTS


A total of 201 infants were included. The procedure was not more successful in the POCUS group (48%) compared to the feeding group (54%) (Difference: 6.5%; 95% CI: -7.3 to 19.8%). The mean time to collect urine samples from randomization to sample collection was not different between the two groups.
CONCLUSIONS


Our study failed to show a benefit of using POCUS to improve the success rate of stimulated clean-catch urine. Moreover, the importance of the feeding period prior to clean-catch urine manoeuvres should be evaluated further.
CLINICAL TRIAL REGISTRATION


NCT02751671.",2019,The procedure was not more successful in the POCUS group (48%) compared to the feeding group (54%),"['infants', '201 infants were included', 'tertiary care pediatric emergency department', '200 children', 'Infants aged less than 6 months needing a urine sample', 'clean-catch urine specimens in infants']","['care ultrasound (POCUS) guided feeding protocol', 'POCUS group or feeding group (standard procedure) before performing a standardized clean-catch urine stimulation technique']","['success of the procedure defined by the collection of at least 2 mL of urine, obtained within 300 seconds of bladder stimulation manoeuvres', 'mean time to collect urine samples']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C1610733', 'cui_str': 'Urine specimen'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0231617', 'cui_str': 'Catch (finding)'}, {'cui': 'C0042037'}]","[{'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0231617', 'cui_str': 'Catch (finding)'}, {'cui': 'C0042037'}, {'cui': 'C0449855', 'cui_str': 'Stimulation technique (qualifier value)'}]","[{'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C0042037'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0005682', 'cui_str': 'Bladder'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1610733', 'cui_str': 'Urine specimen'}]",201.0,0.114939,The procedure was not more successful in the POCUS group (48%) compared to the feeding group (54%),"[{'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Weill', 'Affiliation': 'Department of Pediatrics, Division of Emergency Medicine, CHU Sainte-Justine, Université de Montréal, Montréal, QC.'}, {'ForeName': 'Mélanie', 'Initials': 'M', 'LastName': 'Labrosse', 'Affiliation': 'Department of Pediatrics, Division of Emergency Medicine, CHU Sainte-Justine, Université de Montréal, Montréal, QC.'}, {'ForeName': 'Arielle', 'Initials': 'A', 'LastName': 'Levy', 'Affiliation': 'Department of Pediatrics, Division of Emergency Medicine, CHU Sainte-Justine, Université de Montréal, Montréal, QC.'}, {'ForeName': 'Marie Pier', 'Initials': 'MP', 'LastName': 'Desjardins', 'Affiliation': 'Department of Pediatrics, Division of Emergency Medicine, CHU Sainte-Justine, Université de Montréal, Montréal, QC.'}, {'ForeName': 'Evelyne D', 'Initials': 'ED', 'LastName': 'Trottier', 'Affiliation': 'Department of Pediatrics, Division of Emergency Medicine, CHU Sainte-Justine, Université de Montréal, Montréal, QC.'}, {'ForeName': 'Jocelyn', 'Initials': 'J', 'LastName': 'Gravel', 'Affiliation': 'Department of Pediatrics, Division of Emergency Medicine, CHU Sainte-Justine, Université de Montréal, Montréal, QC.'}]",CJEM,['10.1017/cem.2019.30']
475,31148146,Outpatient vs inpatient total laparoscopic hysterectomy: A randomized controlled trial.,"INTRODUCTION


The objective of the study was to investigate whether outpatient total laparoscopic hysterectomy (TLH) could be performed as a routine without compromising patient satisfaction. The main outcomes were patient satisfaction with length of hospital stay, quality of life, complications and readmissions, and time to return to work.
MATERIAL AND METHODS


A non-blinded prospective randomized controlled trial (Canadian Task Force classification I) performed in a single-center teaching hospital in Denmark. A total of 204 women scheduled for TLH on benign indication were randomized to same-day discharge or overnight stay after TLH. Visual analogue scales (VAS), a validated questionnaire EQ-5D, and a diary were filled in pre- and postoperatively. VAS scores on satisfaction with length of hospital stay and pain were administered taken with the EQ-5D and the diary during a follow up over 4 weeks. Student's t test, Chi-square and non-parametric statistics were used for analysis. The study was registered with ClinicalTrials.gov #NCT02933047.
RESULTS


A total of 204 women gave informed consent and 203 underwent surgery (101 outpatient and 102 inpatient women). Complete data were available for 76 women in the outpatient group and 86 women in the inpatient group. There were no differences in baseline characteristics. No group differences were found in satisfaction with length of hospital stay (P = 0.35). The EQ-5D revealed no difference in patient satisfaction. However, one-third in the outpatient group chose overnight stay without medical indication. The groups were comparable in clinical outcomes. Sick leave was longer in the outpatient group regardless of the actual treatment (P = 0.015).
CONCLUSIONS


Routine outpatient TLH implies that one-third of the patients stay overnight if this option is available without medical indication. Within this context the procedure can be performed with high patient satisfaction, but may lengthen the time to return to work.",2019,No group differences were found in satisfaction with length of hospital stay (P=0.35).,"['76 women in the outpatient group and 86 women in the inpatient group', '204 women scheduled for TLH on benign indication', '204 women gave informed consent and 203 underwent surgery (101 outpatient and 102 inpatient women']","['outpatient total laparoscopic hysterectomy (TLH', 'Outpatient versus inpatient total laparoscopic hysterectomy']","['patient satisfaction with length of hospital stay, quality of life, complications and readmissions, and time to return to work', 'satisfaction with length of hospital stay', 'Sick leave', 'Visual analogue scales (VAS), the validated questionnaire EQ-5D, and a diary', 'patient satisfaction', 'overnight stay without medical indication', 'VAS scores on satisfaction with length of hospital stay and pain']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0205183', 'cui_str': 'Benign (qualifier value)'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0404089', 'cui_str': 'Laparoscopic hysterectomy (procedure)'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}]","[{'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0034380'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0425105', 'cui_str': 'Back to Work'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0242807', 'cui_str': 'Sick Leave'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0439583', 'cui_str': 'Overnight (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",204.0,0.201153,No group differences were found in satisfaction with length of hospital stay (P=0.35).,"[{'ForeName': 'Ulla J', 'Initials': 'UJ', 'LastName': 'Christiansen', 'Affiliation': 'Department of Obstetrics and Gynecology, the Regional Hospital West Jutland, Herning, Denmark.'}, {'ForeName': 'Anne R', 'Initials': 'AR', 'LastName': 'Kruse', 'Affiliation': 'Department of Obstetrics and Gynecology, the Regional Hospital West Jutland, Herning, Denmark.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Olesen', 'Affiliation': 'Department of Obstetrics and Gynecology, the Regional Hospital West Jutland, Herning, Denmark.'}, {'ForeName': 'Finn F', 'Initials': 'FF', 'LastName': 'Lauszus', 'Affiliation': 'Department of Obstetrics and Gynecology, the Regional Hospital West Jutland, Herning, Denmark.'}, {'ForeName': 'Ulrik S', 'Initials': 'US', 'LastName': 'Kesmodel', 'Affiliation': 'Department of Obstetrics and Gynecology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Forman', 'Affiliation': 'Department of Obstetrics and Gynecology, Aarhus University Hospital, Aarhus, Denmark.'}]",Acta obstetricia et gynecologica Scandinavica,['10.1111/aogs.13670']
476,31865790,Blood Pressure Control and the Association With Diabetes Mellitus Incidence: Results From SPRINT Randomized Trial.,"The SPRINT (Systolic Blood Pressure Intervention Trial) demonstrated reduced cardiovascular outcomes. We evaluated diabetes mellitus incidence in this randomized trial that compared intensive blood pressure strategy (systolic blood pressure <120 mm Hg) versus standard strategy (<140 mm Hg). Participants were ≥50 years of age, with systolic 130 to 180 mm Hg and increased cardiovascular risk. Participants were excluded if they had diabetes mellitus, polycystic kidney disease, proteinuria >1 g/d, heart failure, dementia, or stroke. Postrandomization exclusions included participants missing blood glucose or ≥126 mg/dL (6.99 mmol/L) or on hypoglycemics. The outcome was incident diabetes mellitus: fasting blood glucose ≥126 mg/dL (6.99 mmol/L), diabetes mellitus self-report, or new use of hypoglycemics. The secondary outcome was impaired fasting glucose (100-125 mg/dL [5.55-6.94 mmol/L]) among those with normoglycemia (<100 mg/dL [5.55 mmol/L]). There were 9361 participants randomized and 981 excluded, yielding 4187 and 4193 participants assigned to intensive and standard strategies. There were 299 incident diabetes mellitus events (2.3% per year) for intensive and 251 events (1.9% per year) for standard, rates of 22.6 (20.2-25.3) versus 19.0 (16.8-21.5) events per 1000 person-years of treatment, respectively (adjusted hazard ratio, 1.19 [95% CI, 0.95-1.49]). Impaired fasting glucose rates were 26.4 (24.9-28.0) and 22.5 (21.1-24.1) per 100 person-years for intensive and standard strategies (adjusted hazard ratio, 1.17 [1.06-1.30]). Intensive treatment strategy was not associated with increased diabetes mellitus but was associated with more impaired fasting glucose. The risks and benefits of intensive blood pressure targets should be factored into individualized patient treatment goals. Clinical Trial Registration- URL: http://www.clinicaltrials.gov. Unique identifier: NCT01206062.",2020,Intensive treatment strategy was not associated with increased diabetes mellitus but was associated with more impaired fasting glucose.,"['9361 participants randomized and 981 excluded, yielding 4187 and 4193 participants assigned to intensive and standard strategies', 'Participants were excluded if they had diabetes mellitus, polycystic kidney disease, proteinuria >1 g/d, heart failure, dementia, or stroke', 'participants missing blood glucose or ≥126 mg/dL (6.99 mmol/L) or on hypoglycemics', 'Participants were ≥50 years of age, with systolic 130 to 180 mm Hg and increased cardiovascular risk']","['intensive blood pressure strategy (systolic blood pressure <120 mm Hg) versus standard strategy', 'dL']","['impaired fasting glucose', 'diabetes mellitus', 'Impaired fasting glucose rates', 'diabetes mellitus events', 'cardiovascular outcomes', 'Blood Pressure Control and the Association With Diabetes', 'Mellitus Incidence', 'incident diabetes mellitus: fasting blood glucose ≥126 mg/dL (6.99 mmol/L), diabetes mellitus self-report, or new use of hypoglycemics']","[{'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0022680', 'cui_str': 'Polycystic Renal Disease'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C4280965', 'cui_str': '>1'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C1532563', 'cui_str': 'umol/mL'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic Drugs'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C1532563', 'cui_str': 'umol/mL'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic Drugs'}]",299.0,0.215879,Intensive treatment strategy was not associated with increased diabetes mellitus but was associated with more impaired fasting glucose.,"[{'ForeName': 'Christianne L', 'Initials': 'CL', 'LastName': 'Roumie', 'Affiliation': 'From the VA Tennessee Valley Healthcare System Geriatric Research and Education Clinical Center, Nashville, TN (C.L.R., A.M.H.).'}, {'ForeName': 'Adriana M', 'Initials': 'AM', 'LastName': 'Hung', 'Affiliation': 'From the VA Tennessee Valley Healthcare System Geriatric Research and Education Clinical Center, Nashville, TN (C.L.R., A.M.H.).'}, {'ForeName': 'Gregory B', 'Initials': 'GB', 'LastName': 'Russell', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, NC (G.B.R.).'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Basile', 'Affiliation': 'Ralph H Johnson VA Medical Center and Medical University of South Carolina, Charleston (J.B.).'}, {'ForeName': 'Kathryn Evans', 'Initials': 'KE', 'LastName': 'Kreider', 'Affiliation': 'Division of Endocrinology, Metabolism and Nutrition, Department of Medicine, Duke University School of Nursing, Duke University Medical Center, NC (K.E.K.).'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Nord', 'Affiliation': 'Salt Lake City VA Medical Center, Salt Lake City, UT (J.N.).'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Ramsey', 'Affiliation': 'School of Nursing Office of Research and Scholarship, The University of Alabama at Birmingham (T.M.R.).'}, {'ForeName': 'Anjay', 'Initials': 'A', 'LastName': 'Rastogi', 'Affiliation': 'Division of Nephrology, Department of Medicine David Geffen School of Medicine UCLA, Los Angeles, CA (A.R.).'}, {'ForeName': 'Mary Ellen', 'Initials': 'ME', 'LastName': 'Sweeney', 'Affiliation': 'Division of Endocrinology, Diabetes and Lipids, Department of Medicine, Emory University and Atlanta VA Medical Center (M.E.S.).'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Tamariz', 'Affiliation': 'Miami Veterans Healthcare and Division of Population Health and Computational Medicine, University of Miami, FL (L.T.).'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Kostis', 'Affiliation': 'The Cardiovascular Institute at Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ (W.J.K.).'}, {'ForeName': 'Jonathan S', 'Initials': 'JS', 'LastName': 'Williams', 'Affiliation': 'Endocrine Unit, VA Boston Healthcare System, Jamaica Plain, MA (J.S.W.).'}, {'ForeName': 'Athena', 'Initials': 'A', 'LastName': 'Zias', 'Affiliation': 'Northport Veterans Affairs Medical Center, Northport, NY Renaissance School of Medicine at Stony Brook University (A.Z.).'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Cushman', 'Affiliation': 'Memphis Veterans Affairs Medical Center and University of Tennessee Health Science Center, Memphis (W.C.C.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Hypertension (Dallas, Tex. : 1979)",['10.1161/HYPERTENSIONAHA.118.12572']
477,32154784,The Ecofisio Mobile App for Assessment and Diagnosis Using Ultrasound Imaging for Undergraduate Health Science Students: Multicenter Randomized Controlled Trial.,"BACKGROUND


Generation Z is starting to reach college age. They have adopted technology from an early age and have a deep dependence on it; therefore, they have become more drawn to the virtual world. M-learning has experienced huge growth in recent years, both in the medical context and in medical and health sciences education. Ultrasound imaging is an important diagnosis technique in physiotherapy, especially in sports pathology. M-learning systems could be useful tools for improving the comprehension of ultrasound concepts and the acquisition of professional competencies.
OBJECTIVE


The purpose of this study was to evaluate the efficacy and use of an interactive platform accessible through mobile devices-Ecofisio-using ultrasound imaging for the development of professional competencies in the evaluation and diagnosis of sports pathologies.
METHODS


Participants included 110 undergraduate students who were placed into one of two groups of a randomized controlled multicenter study: control group (ie, traditional learning) and experimental group (ie, Ecofisio mobile app). Participants' theoretical knowledge was assessed using a multiple-choice questionnaire (MCQ); students were also assessed by means of the Objective Structured Clinical Examination (OSCE). Moreover, a satisfaction survey was completed by the students.
RESULTS


The statistical analyses revealed that Ecofisio was effective in most of the processes evaluated when compared with the traditional learning method: all OSCE stations, P<.001; MCQ, 43 versus 15 students passed in the Ecofisio and control groups, respectively, P<.001. Moreover, the results revealed that the students found the app to be attractive and useful.
CONCLUSIONS


The Ecofisio mobile app may be an effective way for physiotherapy students to obtain adequate professional competencies regarding evaluation and diagnosis of sports pathologies.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04138511; https://clinicaltrials.gov/ct2/show/NCT04138511.",2020,"The statistical analyses revealed that Ecofisio was effective in most of the processes evaluated when compared with the traditional learning method: all OSCE stations, P<.001; MCQ, 43 versus 15 students passed in the Ecofisio and control groups, respectively, P<.001.","['Participants included 110 undergraduate students who were placed into one of two groups of a randomized controlled multicenter study', 'Undergraduate Health Science Students']","['interactive platform accessible through mobile devices-Ecofisio-using ultrasound imaging', 'control group (ie, traditional learning) and experimental group (ie, Ecofisio mobile app', 'Ultrasound imaging']",['Objective Structured Clinical Examination (OSCE'],"[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0332286', 'cui_str': 'Into (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1096776', 'cui_str': 'Multicenter Study'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0036397', 'cui_str': 'Science'}]","[{'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0041618', 'cui_str': 'Echotomography'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}]","[{'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0031809', 'cui_str': 'Physical Examination'}]",110.0,0.0708381,"The statistical analyses revealed that Ecofisio was effective in most of the processes evaluated when compared with the traditional learning method: all OSCE stations, P<.001; MCQ, 43 versus 15 students passed in the Ecofisio and control groups, respectively, P<.001.","[{'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Lozano-Lozano', 'Affiliation': 'Department of Physical Therapy, University of Granada, Granada, Spain.'}, {'ForeName': 'Noelia', 'Initials': 'N', 'LastName': 'Galiano-Castillo', 'Affiliation': 'Department of Physical Therapy, University of Granada, Granada, Spain.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Fernández-Lao', 'Affiliation': 'Department of Physical Therapy, University of Granada, Granada, Spain.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Postigo-Martin', 'Affiliation': 'Department of Physical Therapy, University of Granada, Granada, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Álvarez-Salvago', 'Affiliation': 'Department of Physical Therapy, University of Granada, Granada, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Arroyo-Morales', 'Affiliation': 'Department of Physical Therapy, University of Granada, Granada, Spain.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Cantarero-Villanueva', 'Affiliation': 'Department of Physical Therapy, University of Granada, Granada, Spain.'}]",Journal of medical Internet research,['10.2196/16258']
478,32159519,Efficacy of a Web App for Cognitive Training (MeMo) Regarding Cognitive and Behavioral Performance in People With Neurocognitive Disorders: Randomized Controlled Trial.,"BACKGROUND


Cognitive and behavioral symptoms are the clinical hallmarks of neurocognitive disorders. Cognitive training may be offered to reduce the risks of cognitive decline and dementia and to reduce behavioral symptoms, such as apathy. Information and communication technology approaches, including serious games, can be useful in improving the playful aspect of computerized cognitive training and providing motivating solutions in elderly patients.
OBJECTIVE


The objective of this study was to assess the effectiveness of employing the MeMo (Memory Motivation) Web app with regard to cognitive and behavioral symptoms in patients with neurocognitive disorders.
METHODS


MeMo is a Web app that can be used on any Web browser (computer or tablet). The training activities proposed in MeMo are divided into the following two parts: memory and mental flexibility/attention. The study included 46 individuals (mean age 79.4 years) with a diagnosis of neurocognitive disorders at the Institut Claude Pompidou Memory Center in Nice. This randomized controlled study compared the evolution of cognition and behavior between patients not using MeMo (control group) and patients using MeMo (MeMo group) for 12 weeks (four sessions per week). Patients underwent memory and attention tests, as well as an apathy assessment at baseline, week 12 (end of the training period), and week 24 (12 weeks after the end of the training sessions). In addition, to assess the impact of high and low game uses, the MeMo group was divided into patients who used MeMo according to the instructions (about once every 2 days; active MeMo group) and those who used it less (nonactive MeMo group).
RESULTS


When comparing cognitive and behavioral scores among baseline, week 12, and week 24, mixed model analysis for each cognitive and behavioral score indicated no significant interaction between testing time and group. On comparing the active MeMo group (n=9) and nonactive MeMo group (n=13), there were significant differences in two attention tests (Trial Making Test A [P=.045] and correct Digit Symbol Substitution Test items [P=.045]) and in the Apathy Inventory (AI) (P=.02). Mixed analysis (time: baseline, week 12, and week 24 × number of active days) indicated only one significant interaction for the AI score (P=.01), with a significant increase in apathy in the nonactive MeMo group.
CONCLUSIONS


This study indicates that the cognitive and behavioral efficacies of MeMo, a Web-based training app, can be observed only with regular use of the app. Improvements were observed in attention and motivation.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04142801; https://clinicaltrials.gov/ct2/show/NCT04142801.",2020,"Information and communication technology approaches, including serious games, can be useful in improving the playful aspect of computerized cognitive training and providing motivating solutions in elderly patients.
","['patients with neurocognitive disorders', 'People With Neurocognitive Disorders', '46 individuals (mean age 79.4 years) with a diagnosis of neurocognitive disorders at the Institut Claude Pompidou Memory Center in Nice', 'patients not using MeMo (control group) and patients using', 'elderly patients']","['Cognitive training', 'MeMo (MeMo group', 'Web App for Cognitive Training (MeMo', 'nonactive MeMo']","['attention and motivation', 'AI score', 'correct Digit Symbol Substitution Test items [P=.045]) and in the Apathy Inventory (AI', 'Cognitive and Behavioral Performance']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4041080', 'cui_str': 'Neurocognitive Disorders'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0721912', 'cui_str': ""N'ICE""}, {'cui': 'C0445107', 'cui_str': 'Not used (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0582802', 'cui_str': 'Digit'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0085632', 'cui_str': 'Apathy'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",46.0,0.0667222,"Information and communication technology approaches, including serious games, can be useful in improving the playful aspect of computerized cognitive training and providing motivating solutions in elderly patients.
","[{'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Robert', 'Affiliation': ""Cognition Behaviour Technology Lab, Université Côte d'Azur, Nice, France.""}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Manera', 'Affiliation': ""Cognition Behaviour Technology Lab, Université Côte d'Azur, Nice, France.""}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Derreumaux', 'Affiliation': 'Association Innovation Alzheimer, Nice, France.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Ferrandez Y Montesino', 'Affiliation': 'Association Innovation Alzheimer, Nice, France.'}, {'ForeName': 'Elsa', 'Initials': 'E', 'LastName': 'Leone', 'Affiliation': 'Centre Memoire, Centre Hospitalier Universitaire de Nice, Nice, France.'}, {'ForeName': 'Roxane', 'Initials': 'R', 'LastName': 'Fabre', 'Affiliation': 'Departement de Santé Publique, Centre Hospitalier Universitaire de Nice, Nice, France.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Bourgeois', 'Affiliation': 'Centre Memoire, Centre Hospitalier Universitaire de Nice, Nice, France.'}]",Journal of medical Internet research,['10.2196/17167']
479,32163038,Utilization of a Voice-Based Virtual Reality Advanced Cardiac Life Support Team Leader Refresher: Prospective Observational Study.,"BACKGROUND


The incidence of cardiac arrests per year in the United States continues to increase, yet in-hospital cardiac arrest survival rates significantly vary between hospitals. Current methods of training are expensive, time consuming, and difficult to scale, which necessitates improvements in advanced cardiac life support (ACLS) training. Virtual reality (VR) has been proposed as an alternative or adjunct to high-fidelity simulation (HFS) in several environments. No evaluations to date have explored the ability of a VR program to examine both technical and behavioral skills and demonstrate a cost comparison.
OBJECTIVE


This study aimed to explore the utility of a voice-based VR ACLS team leader refresher as compared with HFS.
METHODS


This prospective observational study performed at an academic institution consisted of 25 postgraduate year 2 residents. Participants were randomized to HFS or VR training and then crossed groups after a 2-week washout. Participants were graded on technical and nontechnical skills. Participants also completed self-assessments about the modules. Proctors were assessed for fatigue and task saturation, and cost analysis based on local economic data was performed.
RESULTS


A total of 23 of 25 participants were included in the scoring analysis. Fewer participants were familiar with VR compared with HFS (9/25, 36% vs 25/25, 100%; P<.001). Self-reported satisfaction and utilization scores were similar; however, significantly more participants felt HFS provided better feedback: 99 (IQR 89-100) vs 79 (IQR 71-88); P<.001. Technical scores were higher in the HFS group; however, nontechnical scores for decision making and communication were not significantly different between modalities. VR sessions were 21 (IQR 19-24) min shorter than HFS sessions, the National Aeronautics and Space Administration task load index scores for proctors were lower in each category, and VR sessions were estimated to be US $103.68 less expensive in a single-learner, single-session model.
CONCLUSIONS


Utilization of a VR-based team leader refresher for ACLS skills is comparable with HFS in several areas, including learner satisfaction. The VR module was more cost-effective and was easier to proctor; however, HFS was better at delivering feedback to participants. Optimal education strategies likely contain elements of both modalities. Further studies are needed to examine the utility of VR-based environments at scale.",2020,"Technical scores were higher in the HFS group; however, nontechnical scores for decision making and communication were not significantly different between modalities.","['A total of 23 of 25 participants were included in the scoring analysis', 'academic institution consisted of 25 postgraduate year 2 residents']","['Virtual reality (VR', 'HFS', 'HFS or VR training']","['fatigue and task saturation, and cost analysis based on local economic data', 'National Aeronautics and Space Administration task load index scores', 'nontechnical scores for decision making and communication', 'Technical scores', 'Self-reported satisfaction and utilization scores']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C1272753', 'cui_str': 'Institution'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0010171', 'cui_str': 'Cost Analysis'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0013557', 'cui_str': 'economics'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0042153', 'cui_str': 'use'}]",25.0,0.0242053,"Technical scores were higher in the HFS group; however, nontechnical scores for decision making and communication were not significantly different between modalities.","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Katz', 'Affiliation': 'Department of Anesthesiology, Pain, & Perioperative Medicine, Icahn School of Medicine at Mount Sinai, New York, NY, United States.'}, {'ForeName': 'Ronak', 'Initials': 'R', 'LastName': 'Shah', 'Affiliation': 'Department of Anesthesiology, Pain, & Perioperative Medicine, Icahn School of Medicine at Mount Sinai, New York, NY, United States.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Kim', 'Affiliation': 'City University of New York City Medical School, New York, NY, United States.'}, {'ForeName': 'Chang', 'Initials': 'C', 'LastName': 'Park', 'Affiliation': 'Department of Anesthesiology, Pain, & Perioperative Medicine, Icahn School of Medicine at Mount Sinai, New York, NY, United States.'}, {'ForeName': 'Anjan', 'Initials': 'A', 'LastName': 'Shah', 'Affiliation': 'Department of Anesthesiology, Pain, & Perioperative Medicine, Icahn School of Medicine at Mount Sinai, New York, NY, United States.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Levine', 'Affiliation': 'Department of Anesthesiology, Pain, & Perioperative Medicine, Icahn School of Medicine at Mount Sinai, New York, NY, United States.'}, {'ForeName': 'Garrett', 'Initials': 'G', 'LastName': 'Burnett', 'Affiliation': 'Department of Anesthesiology, Pain, & Perioperative Medicine, Icahn School of Medicine at Mount Sinai, New York, NY, United States.'}]",Journal of medical Internet research,['10.2196/17425']
480,32227368,Weight suppression and weight maintenance following treatment of anorexia nervosa.,"OBJECTIVE


The value of weight suppression (WS) in predicting the course of anorexia nervosa (AN) is uncertain. The objective of this study was to determine, using data from a previously published study, whether patients who remain weight suppressed following restoration to a minimally normal weight are at greater risk for relapse.
METHOD


Following weight restoration, 93 women with AN were randomly assigned to receive fluoxetine or placebo along with cognitive behavioral therapy for 1 year. WS (highest adult weight minus current weight), body mass index (BMI), and their interaction were assessed as predictors of change in weight over the first 28 days, of successful weight maintenance at 6 and 12 months, and of time to relapse.
RESULTS


Neither WS nor its interaction with BMI predicted successful weight maintenance at 6 and 12 months, time to relapse, or weight change over the first 28 days following discharge.
DISCUSSION


This study found that WS does not substantially impact the likelihood of successful weight maintenance or time to relapse following restoration to a minimally normal weight in AN.",2020,"Neither WS nor its interaction with BMI predicted successful weight maintenance at 6 and 12 months, time to relapse, or weight change over the first 28 days following discharge.
","['93 women with AN', 'anorexia nervosa', 'patients who remain weight suppressed following restoration to a minimally normal weight are at greater risk for relapse']","['fluoxetine or placebo', 'weight suppression (WS', 'cognitive behavioral therapy']","['Weight suppression and weight maintenance', 'successful weight maintenance', 'time to relapse, or weight change', 'WS (highest adult weight minus current weight), body mass index (BMI), and their interaction']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0003125', 'cui_str': 'Anorexia Nervosas'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1260953', 'cui_str': 'Suppressed (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration (attribute)'}, {'cui': 'C2712185', 'cui_str': 'Normal weight (finding)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}]","[{'cui': 'C0016365', 'cui_str': 'Fluoxetine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332288', 'cui_str': 'Without (attribute)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}]",93.0,0.0544804,"Neither WS nor its interaction with BMI predicted successful weight maintenance at 6 and 12 months, time to relapse, or weight change over the first 28 days following discharge.
","[{'ForeName': 'Blair', 'Initials': 'B', 'LastName': 'Uniacke', 'Affiliation': 'Department of Psychiatry, Columbia University Irving Medical Center, New York, New York, USA.'}, {'ForeName': 'Evelyn', 'Initials': 'E', 'LastName': 'Attia', 'Affiliation': 'Department of Psychiatry, Columbia University Irving Medical Center, New York, New York, USA.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Kaplan', 'Affiliation': 'Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'B Timothy', 'Initials': 'BT', 'LastName': 'Walsh', 'Affiliation': 'Department of Psychiatry, Columbia University Irving Medical Center, New York, New York, USA.'}]",The International journal of eating disorders,['10.1002/eat.23269']
481,32102629,Redefined Measure of Early Neurological Improvement Shows Treatment Benefit of Alteplase Over Placebo.,"Background and Purpose- The first of the 2 NINDS (National Institute of Neurological Disorders and Stroke) Study trials did not show a significant increase in early neurological improvement, defined as National Institutes of Health Stroke Scale (NIHSS) improvement by ≥4, with alteplase treatment. We hypothesized that early neurological improvement defined as a percentage change in NIHSS (percent change NIHSS) at 24 hours is superior to other definitions in predicting 3-month functional outcomes and using this definition there would be treatment benefit of alteplase over placebo at 24 hours. Methods- We analyzed the NINDS rt-PA Stroke Study (Parts 1 and 2) trial data. Percent change NIHSS was defined as ([admission NIHSS score-24-hour NIHSS score]×100/admission NIHSS score] and delta NIHSS as (admission NIHSS score-24-hour NIHSS score). We compared early neurological improvement using these definitions between alteplase versus placebo patients. We also used receiver operating characteristic curve to determine the predictive association of early neurological improvement with excellent 3-month functional outcomes (Barthel Index score of 95-100 and modified Rankin Scale score of 0-1), good 3-month functional outcome (modified Rankin Scale score of 0-2), and 3-month infarct volume. Results- There was a significantly greater improvement in the 24-hour median percent change NIHSS among patients treated with alteplase compared with the placebo group (28% versus 15%;  P =0.045) but not median delta NIHSS (3 versus 2;  P =0.471). Receiver operating characteristic curve comparison showed that percent change NIHSS (ROC percent ) was better than delta NIHSS (ROC delta ) and admission NIHSS (ROC admission ) with regards to excellent 3-month Barthel Index (ROC percent , 0.83; ROC delta , 0.76; ROC admission , 0.75), excellent 3-month modified Rankin Scale (ROC percent , 0.83; ROC delta , 0.74; ROC admission , 0.78), and good 3-month modified Rankin Scale (ROC percent , 0.83; ROC delta , 0.76; ROC admission , 0.78). Conclusions- In the NINDS rt-PA trial, alteplase was associated with a significant percent change improvement in NIHSS at 24 hours. Percent change in NIHSS may be a better surrogate marker of thrombolytic activity and 3-month outcomes.",2020,There was a significantly greater improvement in the 24-hour median percent change NIHSS among patients treated with alteplase compared with the placebo group (28% versus 15%;  P =0.045) but not median delta NIHSS (3 versus 2;  P =0.471).,[],"['placebo', 'Methods', ' and Purpose', 'Placebo', 'Conclusions']","['functional outcomes (Barthel Index score of 95-100 and modified Rankin Scale score of 0-1), good 3-month functional outcome (modified Rankin Scale score of 0-2), and 3-month infarct volume', '24-hour median percent change NIHSS', 'early neurological improvement, defined as National Institutes of Health Stroke Scale (NIHSS) improvement', 'excellent 3-month modified Rankin Scale', 'delta NIHSS (ROC delta ) and admission NIHSS (ROC admission ', 'good 3-month modified Rankin Scale']",[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C1285529', 'cui_str': 'Purpose (attribute)'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0451019', 'cui_str': 'Barthel index (assessment scale)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0021308', 'cui_str': 'Infarction'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0222045'}, {'cui': 'C1961136', 'cui_str': 'Excellent (qualifier value)'}, {'cui': 'C0439097', 'cui_str': 'Delta'}]",,0.0713408,There was a significantly greater improvement in the 24-hour median percent change NIHSS among patients treated with alteplase compared with the placebo group (28% versus 15%;  P =0.045) but not median delta NIHSS (3 versus 2;  P =0.471).,"[{'ForeName': 'Shashank', 'Initials': 'S', 'LastName': 'Agarwal', 'Affiliation': 'From the Department of Neurology, New York Langone Health (S.A., E.S., A.L., J.F., K.I., J.T., S.R., S.Y.).'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Scher', 'Affiliation': 'From the Department of Neurology, New York Langone Health (S.A., E.S., A.L., J.F., K.I., J.T., S.R., S.Y.).'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Lord', 'Affiliation': 'From the Department of Neurology, New York Langone Health (S.A., E.S., A.L., J.F., K.I., J.T., S.R., S.Y.).'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Frontera', 'Affiliation': 'From the Department of Neurology, New York Langone Health (S.A., E.S., A.L., J.F., K.I., J.T., S.R., S.Y.).'}, {'ForeName': 'Koto', 'Initials': 'K', 'LastName': 'Ishida', 'Affiliation': 'From the Department of Neurology, New York Langone Health (S.A., E.S., A.L., J.F., K.I., J.T., S.R., S.Y.).'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Torres', 'Affiliation': 'From the Department of Neurology, New York Langone Health (S.A., E.S., A.L., J.F., K.I., J.T., S.R., S.Y.).'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Rostanski', 'Affiliation': 'From the Department of Neurology, New York Langone Health (S.A., E.S., A.L., J.F., K.I., J.T., S.R., S.Y.).'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Mistry', 'Affiliation': 'Department of Neurology, Vanderbilt University Medical Center, Nashville, TN (E.M.).'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Mac Grory', 'Affiliation': 'Department of Neurology, The Warren Alpert Medical School of Brown University, Providence, RI (B.M.G., S.C., T.B., K.F.).'}, {'ForeName': 'Shawna', 'Initials': 'S', 'LastName': 'Cutting', 'Affiliation': 'Department of Neurology, The Warren Alpert Medical School of Brown University, Providence, RI (B.M.G., S.C., T.B., K.F.).'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Burton', 'Affiliation': 'Department of Neurology, The Warren Alpert Medical School of Brown University, Providence, RI (B.M.G., S.C., T.B., K.F.).'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Silver', 'Affiliation': 'Department of Neurology, University of Massachusetts Medical School, Worcester (B.S.).'}, {'ForeName': 'Ava L', 'Initials': 'AL', 'LastName': 'Liberman', 'Affiliation': 'Department of Neurology, Albert Einstein College of Medicine, NY (A.L.L.).'}, {'ForeName': 'Mackenzie P', 'Initials': 'MP', 'LastName': 'Lerario', 'Affiliation': 'Department of Neurology, Weill Cornell Medical College, NY (M.P.L.).'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Furie', 'Affiliation': 'Department of Neurology, The Warren Alpert Medical School of Brown University, Providence, RI (B.M.G., S.C., T.B., K.F.).'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Grotta', 'Affiliation': 'Department of Neurology, Memorial Hermann Hospital, Texas Medical Center, Houston (J.G.).'}, {'ForeName': 'Pooja', 'Initials': 'P', 'LastName': 'Khatri', 'Affiliation': 'Department of Neurology, University of Cincinnati, OH (P.K.).'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Saver', 'Affiliation': 'Department of Neurology, Ronald Reagan UCLA Medical Center, Santa Monica, CA (J.S.).'}, {'ForeName': 'Shadi', 'Initials': 'S', 'LastName': 'Yaghi', 'Affiliation': 'From the Department of Neurology, New York Langone Health (S.A., E.S., A.L., J.F., K.I., J.T., S.R., S.Y.).'}]",Stroke,['10.1161/STROKEAHA.119.027476']
482,32039852,A Structured Physical Exercise Program Reduces Professional Caregiver's Burden Caused by Neuropsychiatric Symptoms in Acute Dementia Care: Randomized Controlled Trial Results.,"Physical exercise is an effective treatment approach for neuropsychiatric symptoms (NPS), but it is unknown whether the reduction of NPS has an impact on professional caregiver's burden. A randomized controlled trial in acute dementia care with N = 70 patients, n = 35 per group, was conducted. The intervention group (IG) received an exercise program, the control group a social stimulation program. The RM-ANOVA showed a significant group x time interaction with time effects for the IG and decreased caregiver burden due to the exercise program at follow-up. Physical exercise programs may not only be beneficial for the patients but also for their professional caregivers.",2020,The RM-ANOVA showed a significant group x time interaction with time effects for the IG and decreased caregiver burden due to the exercise program at follow-up.,"['Acute Dementia Care', 'acute dementia care with N\u200a=\u200a70 patients, n\u200a=\u200a35 per group, was conducted']","['Physical exercise', 'exercise program, the control group a social stimulation program', 'Physical exercise programs', 'Physical Exercise Program']",[],"[{'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}]",[],70.0,0.0604697,The RM-ANOVA showed a significant group x time interaction with time effects for the IG and decreased caregiver burden due to the exercise program at follow-up.,"[{'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Fleiner', 'Affiliation': 'Department of Geriatric Psychiatry & Psychotherapy, LVR Hospital Cologne, Cologne, Germany.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Dauth', 'Affiliation': 'Department of Geriatric Psychiatry & Psychotherapy, LVR Hospital Cologne, Cologne, Germany.'}, {'ForeName': 'Wiebren', 'Initials': 'W', 'LastName': 'Zijlstra', 'Affiliation': 'Institute of Movement and Sport Gerontology, German Sport University Cologne, Cologne, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Haussermann', 'Affiliation': 'Department of Geriatric Psychiatry & Psychotherapy, LVR Hospital Cologne, Cologne, Germany.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-191102']
483,31988481,Effectiveness and cost-effectiveness of The Daily Mile on childhood weight outcomes and wellbeing: a cluster randomised controlled trial.,"BACKGROUND


The Daily Mile is designed to increase physical activity levels with children running or walking around school grounds for 15-min daily. It has been adopted by schools worldwide and endorsed as a solution to tackle obesity, despite no robust evidence of its benefits. We conducted a cluster randomised controlled trial to determine its clinical and cost-effectiveness.
METHODS


Forty schools were randomly assigned (1:1) to either the Daily Mile intervention or control group in which only the usual school health and wellbeing activities were implemented. The primary outcome was BMI z-score (BMIz) at 12 months follow-up from baseline, with planned subgroup analysis to examine differential effects. Primary economic analysis outcome was incremental cost per Quality-Adjusted-Life-Year (QALY) gained.
RESULTS


Using a constrained randomisation approach, balanced on school size, baseline BMIz and proportion of pupils eligible for free school meals, 20 schools were allocated to intervention (n = 1,153 participants) and 20 to control (n = 1,127); 3 schools withdrew (2 intervention, 1 control). At 12 months, BMIz data were available for 18 intervention schools (n = 850) and 19 control schools (n = 820 participants). Using intention-to-treat analysis the adjusted mean difference (MD) in BMIz (intervention - control) was -0.036 (95% CI: -0.085 to 0.013, p = 0.146). Pre-specified subgroup analysis showed a significant interaction with sex (p = 0.001) suggesting a moderate size benefit of The Daily Mile in girls (MD -0.097, 95% CI -0.156 to -0.037). This was consistent with the exploratory economic results that showed The Daily Mile to be highly cost-effective in girls (£2,492 per QALY), but not in boys, and overall to have a 76% chance of cost-effectiveness for the whole sample, at the commonly applied UK threshold of £20,000 per QALY.
CONCLUSIONS


Overall the Daily Mile had a small but non-significant effect on BMIz, however, it had a greater effect in girls suggesting that it might be considered as a cost-effective component of a system-wide approach to childhood obesity prevention.",2020,"Overall the Daily Mile had a small but non-significant effect on BMIz, however, it had a greater effect in girls suggesting that it might be considered as a cost-effective component of a system-wide approach to childhood obesity prevention.","['pupils eligible for free school meals, 20 schools', 'Forty schools']","['Daily Mile', 'Daily Mile intervention or control group in which only the usual school health and wellbeing activities were implemented']","['Effectiveness and cost-effectiveness', 'physical activity levels', 'childhood weight outcomes and wellbeing', 'BMI z-score (BMIz', 'BMIz', 'incremental cost per Quality-Adjusted-Life-Year (QALY) gained']","[{'cui': 'C0034121', 'cui_str': 'Pupil'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0331865', 'cui_str': 'Mile (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'QALY'}]",40.0,0.246083,"Overall the Daily Mile had a small but non-significant effect on BMIz, however, it had a greater effect in girls suggesting that it might be considered as a cost-effective component of a system-wide approach to childhood obesity prevention.","[{'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Breheny', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, B15 2TT, UK.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Passmore', 'Affiliation': 'Services for Education, Birmingham, B7 4AX, UK.'}, {'ForeName': 'Peymane', 'Initials': 'P', 'LastName': 'Adab', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, B15 2TT, UK. p.adab@bham.ac.uk.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Martin', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, B15 2TT, UK.'}, {'ForeName': 'Karla', 'Initials': 'K', 'LastName': 'Hemming', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, B15 2TT, UK.'}, {'ForeName': 'Emma R', 'Initials': 'ER', 'LastName': 'Lancashire', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, B15 2TT, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Frew', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, B15 2TT, UK. e.frew@bham.ac.uk.'}]",International journal of obesity (2005),['10.1038/s41366-019-0511-0']
484,32157905,Laparoscopic Surgery Versus Open Surgery for Colorectal Cancer: Impacts on Natural Killer Cells.,"Background:  Laparoscopic resection is increasingly used in colorectal cancer (CRC). It has been suggested to carry short-term benefits in safety, recovery, and preservation on immune function for patients with CRC. However, the impact of laparoscopic resection on natural killer (NK) cells is largely unclear.
METHODS


A total of 200 patients with CRC across Dukes A/B/C stages were randomly assigned to laparoscopic or open resection. The blood samples were collected before and after the surgery. The total number of NK cells was quantified by flow cytometer. Lytic units 35 toward K562 was used to quantify NK cells activity. The outcomes between the groups across pathological stages were also analyzed.
RESULTS


The number and activity of NK cells decreased after the surgery in both groups. The laparoscopic group showed a faster recovery rate of NK cells function than the control group as assessed by cell count and lytic activity. Natural killer cells were impaired in a higher degree in patients at Dukes B/C stages. The recovery of NK cells to baseline level at day 7 postsurgery was observed in the laparoscopic group across all 3 stages.
CONCLUSION


Generally, laparoscopically assisted surgery resulted in a better preservation on NK cells function. A better outcome was observed in patients with CRC at Dukes B/C stages.",2020,The laparoscopic group showed a faster recovery rate of NK cells function than the control group as assessed by cell count and lytic activity.,"['Colorectal Cancer', 'colorectal cancer (CRC', 'patients with CRC', '200 patients with CRC across Dukes A/B/C stages']","['laparoscopically assisted surgery', 'Laparoscopic Surgery Versus Open Surgery', 'laparoscopic or open resection', 'laparoscopic resection', 'Laparoscopic resection']","['recovery of NK cells to baseline level', 'natural killer (NK) cells', 'recovery rate of NK cells function', 'Natural killer cells', 'total number of NK cells', 'NK cells function', 'number and activity of NK cells', 'blood samples', 'cell count and lytic activity']","[{'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0170127', 'cui_str': 'Calcibiotic Root Canal Sealer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}]","[{'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0751429', 'cui_str': 'Surgical Procedures, Laparoscopic'}, {'cui': 'C0348025', 'cui_str': 'Open approach - access (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}]","[{'cui': 'C0022688', 'cui_str': 'NK Cells'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0007584', 'cui_str': 'Cell Number'}, {'cui': 'C0439680', 'cui_str': 'Lytic (qualifier value)'}]",200.0,0.0682478,The laparoscopic group showed a faster recovery rate of NK cells function than the control group as assessed by cell count and lytic activity.,"[{'ForeName': 'Liangpan', 'Initials': 'L', 'LastName': 'Shi', 'Affiliation': 'Department of Gastrointestinal Surgery, The First Hospital of Quanzhou Affiliated to Fujian Medical University, Quanzhou, Fujian, China.'}, {'ForeName': 'Hailian', 'Initials': 'H', 'LastName': 'Guo', 'Affiliation': 'Department of Gynaecology and Obstetrics, Jinjiang Hospital, Jinjiang, Fujian, China.'}, {'ForeName': 'Zhihua', 'Initials': 'Z', 'LastName': 'Zheng', 'Affiliation': 'Department of Gastrointestinal Surgery, The First Hospital of Quanzhou Affiliated to Fujian Medical University, Quanzhou, Fujian, China.'}, {'ForeName': 'Jiangrui', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Gastrointestinal Surgery, The First Hospital of Quanzhou Affiliated to Fujian Medical University, Quanzhou, Fujian, China.'}, {'ForeName': 'Yancheng', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Department of Laboratory Medicine, The First Hospital of Quanzhou Affiliated to Fujian Medical University, Quanzhou, Fujian, China.'}, {'ForeName': 'Yibin', 'Initials': 'Y', 'LastName': 'Su', 'Affiliation': 'Department of Gastrointestinal Surgery, The First Hospital of Quanzhou Affiliated to Fujian Medical University, Quanzhou, Fujian, China.'}]",Cancer control : journal of the Moffitt Cancer Center,['10.1177/1073274820906811']
485,31630098,"Perceptions, experiences and barriers to lifestyle modifications in first-generation Middle Eastern immigrants to Sweden: a qualitative study.","OBJECTIVE


The prevalence of type 2 diabetes (T2D) among Iraqi immigrants to Sweden is high and partly related to sedentary physical activity and calorie dense food. The aim of the present study was to explore perceptions, experiences and barriers concerning lifestyle modifications (LSM) in Iraqi immigrants to Sweden at risk for T2D.
DESIGN


A qualitative thematic analysis was conducted on data collected from gender-specific focus group interviews which took place during a culturally adapted randomised controlled intervention study addressing motivation to lifestyle change, self-empowerment, behavioural modifications and sociocultural barriers to LSM. Seven focus groups were held, with an interval of 1-4 weeks between January and May of 2015; each session lasted approximately 1.5 hours.
SETTING


The city of Malmö, Sweden.
PARTICIPANTS


Out of 27 women and 23 men assigned to the intervention group, 19 women and 14 men who attended at least one focus group session were included in the study.
RESULTS


Participants expressed awareness of the content of healthy lifestyle practices. They also expressed numerous social and cultural barriers to LSM connected to irregular meals, overeating, food and drinking preferences and family expectations. Overeating was described as a consequence of social and cultural norms and expectations and of poor mental well-being. Facilitators for reaching successful LSM were connected to family involvement and support.
CONCLUSION


Our study reports that facilitators for LSM are connected to presence of family support. Preventive actions addressing family involvement may benefit Middle Eastern immigrants at high risk for T2D to consider healthier lifestyles practices. Identification of sociocultural barriers and facilitators for LSM are crucial for successful health promotion in minority populations at risk for T2D.
TRIAL REGISTRATION


Trial registration number: NCT01420198 for the MEDIM-study; Pre-results.",2019,Preventive actions addressing family involvement may benefit Middle Eastern immigrants at high risk for T2D to consider healthier lifestyles practices.,"['Iraqi immigrants to Sweden at risk for T2D', 'first-generation Middle Eastern immigrants to Sweden', 'Out of 27 women and 23 men assigned to the intervention group, 19 women and 14 men who attended at least one focus group session were included in the study', 'The city of Malmö, Sweden']",[],[],"[{'cui': 'C1556087', 'cui_str': 'Iraqi (ethnic group)'}, {'cui': 'C0282163', 'cui_str': 'Immigrants'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0016400', 'cui_str': 'Focus Groups'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0008848', 'cui_str': 'Cities'}]",[],[],19.0,0.0345639,Preventive actions addressing family involvement may benefit Middle Eastern immigrants at high risk for T2D to consider healthier lifestyles practices.,"[{'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Olaya-Contreras', 'Affiliation': 'Institute of Health and Care Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenborg, Sweden patricia.olaya-contreras@gu.se.'}, {'ForeName': 'Katarina', 'Initials': 'K', 'LastName': 'Balcker-Lundgren', 'Affiliation': 'Center for Primary Health Care Research, Region Skåne and Lund University, Malmö, Sweden.'}, {'ForeName': 'Faiza', 'Initials': 'F', 'LastName': 'Siddiqui', 'Affiliation': 'Center for Primary Health Care Research, Region Skåne and Lund University, Malmö, Sweden.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Bennet', 'Affiliation': 'Center for Primary Health Care Research, Region Skåne and Lund University, Malmö, Sweden.'}]",BMJ open,['10.1136/bmjopen-2018-028076']
486,32223113,Rivaroxaban or Enoxaparin in Nonmajor Orthopedic Surgery.,"BACKGROUND


Nonmajor orthopedic surgery of the lower limbs that results in transient reduced mobility places patients at risk for venous thromboembolism. Rivaroxaban may be noninferior to enoxaparin with regard to the prevention of major venous thromboembolism in these patients.
METHODS


In this international, parallel-group, randomized, double-blind, noninferiority trial, we randomly assigned adult patients undergoing lower-limb nonmajor orthopedic surgery who were considered to be at risk for venous thromboembolism on the basis of the investigator's judgment to receive either rivaroxaban or enoxaparin. The primary efficacy outcome of major venous thromboembolism was a composite of symptomatic distal or proximal deep-vein thrombosis, pulmonary embolism, or venous thromboembolism-related death during the treatment period or asymptomatic proximal deep-vein thrombosis at the end of treatment. A test for superiority was planned if rivaroxaban proved to be noninferior to enoxaparin. For all outcomes, multiple imputation was used to account for missing data. Prespecified safety outcomes included major bleeding (fatal, critical, or clinically overt bleeding or bleeding at the surgical site leading to intervention) and nonmajor clinically relevant bleeding.
RESULTS


A total of 3604 patients underwent randomization; 1809 patients were assigned to receive rivaroxaban, and 1795 to receive enoxaparin. Major venous thromboembolism occurred in 4 of 1661 patients (0.2%) in the rivaroxaban group and in 18 of 1640 patients (1.1%) in the enoxaparin group (risk ratio with multiple imputation, 0.25; 95% confidence interval, 0.09 to 0.75; P<0.001 for noninferiority; P = 0.01 for superiority). The incidence of bleeding did not differ significantly between the rivaroxaban group and the enoxaparin group (1.1% and 1.0%, respectively, for major bleeding or nonmajor clinically relevant bleeding; 0.6% and 0.7%, respectively, for major bleeding).
CONCLUSIONS


Rivaroxaban was more effective than enoxaparin in the prevention of venous thromboembolic events during a period of immobilization after nonmajor orthopedic surgery of the lower limbs. (Funded by Centre Hospitalier Universitaire de Saint-Etienne and Bayer; PRONOMOS ClinicalTrials.gov number, NCT02401594.).",2020,A test for superiority was planned if rivaroxaban proved to be noninferior to enoxaparin.,"['Nonmajor Orthopedic Surgery', '3604 patients underwent randomization; 1809 patients', ""adult patients undergoing lower-limb nonmajor orthopedic surgery who were considered to be at risk for venous thromboembolism on the basis of the investigator's judgment to receive either""]","['enoxaparin', 'Rivaroxaban', 'Rivaroxaban or Enoxaparin', 'rivaroxaban', 'rivaroxaban or enoxaparin']","['venous thromboembolic events', 'incidence of bleeding', 'major venous thromboembolism was a composite of symptomatic distal or proximal deep-vein thrombosis, pulmonary embolism, or venous thromboembolism-related death during the treatment period or asymptomatic proximal deep-vein thrombosis', 'major bleeding or nonmajor clinically relevant bleeding', 'Major venous thromboembolism', 'major bleeding (fatal, critical, or clinically overt bleeding or bleeding at the surgical site leading to intervention) and nonmajor clinically relevant bleeding']","[{'cui': 'C0162439', 'cui_str': 'Orthopedic Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C1861172', 'cui_str': 'Venous Thromboembolism'}, {'cui': 'C1626935', 'cui_str': 'Base'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0022423', 'cui_str': 'Judgment'}]","[{'cui': 'C0206460', 'cui_str': 'Enoxaparin'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}]","[{'cui': 'C0348013', 'cui_str': 'Venous (qualifier value)'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolism'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1861172', 'cui_str': 'Venous Thromboembolism'}, {'cui': 'C1292718', 'cui_str': 'Is a'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0149871', 'cui_str': 'Deep Vein Thrombosis'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary Embolism'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0023175', 'cui_str': 'Lead'}]",3604.0,0.445584,A test for superiority was planned if rivaroxaban proved to be noninferior to enoxaparin.,"[{'ForeName': 'C Marc', 'Initials': 'CM', 'LastName': 'Samama', 'Affiliation': 'From the Department of Anesthesia and Critical Care, Groupe Hospitalo-Universitaire Assistance Publique-Hôpitaux de Paris Centre-Université de Paris, Hôpital Cochin (C.M.S., N.R.), Unité de Recherche Clinique, Innovation, Pharmacologie, Centre Hospitalier Universitaire de Saint-Etienne, Sainboise INSERM Unité 1059, Université Jean Monnet, and INSERM CIE1408 (S.L., B.D., E.P., P. Mismetti), French Clinical Research Infrastructure Network (F-CRIN), Investigation Network on Venous Thromboembolism (INNOVTE) (S.L., P.G., P. Mismetti), and Institut du Thorax Curie-Montsouris, Institut Mutualiste Montsouris (P.G.), Paris, INSERM Centre National de la Recherche Scientifique 5558, Université Claude Bernard, Université de Lyon, Lyon (M.C.), and the Department of Anesthesia and Critical Care, Polyclinique du Parc, Saint Saulve (D.D.) - all in France; the Department of Anesthesia and Critical Care, University Hospital Doctor Peset, Valencia (J.L.), and the Department of Anesthesia and Critical Care, Hospital Universitario Fundación de Alcorcón, Madrid (J.M.-M.) - both in Spain; Sektionsleiter Endoprothetik, Sana Klinikum Offenbach, Offenbach am Main, Germany (P. Mouret); and McGill University, Montreal (W.F.).'}, {'ForeName': 'Silvy', 'Initials': 'S', 'LastName': 'Laporte', 'Affiliation': 'From the Department of Anesthesia and Critical Care, Groupe Hospitalo-Universitaire Assistance Publique-Hôpitaux de Paris Centre-Université de Paris, Hôpital Cochin (C.M.S., N.R.), Unité de Recherche Clinique, Innovation, Pharmacologie, Centre Hospitalier Universitaire de Saint-Etienne, Sainboise INSERM Unité 1059, Université Jean Monnet, and INSERM CIE1408 (S.L., B.D., E.P., P. Mismetti), French Clinical Research Infrastructure Network (F-CRIN), Investigation Network on Venous Thromboembolism (INNOVTE) (S.L., P.G., P. Mismetti), and Institut du Thorax Curie-Montsouris, Institut Mutualiste Montsouris (P.G.), Paris, INSERM Centre National de la Recherche Scientifique 5558, Université Claude Bernard, Université de Lyon, Lyon (M.C.), and the Department of Anesthesia and Critical Care, Polyclinique du Parc, Saint Saulve (D.D.) - all in France; the Department of Anesthesia and Critical Care, University Hospital Doctor Peset, Valencia (J.L.), and the Department of Anesthesia and Critical Care, Hospital Universitario Fundación de Alcorcón, Madrid (J.M.-M.) - both in Spain; Sektionsleiter Endoprothetik, Sana Klinikum Offenbach, Offenbach am Main, Germany (P. Mouret); and McGill University, Montreal (W.F.).'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Rosencher', 'Affiliation': 'From the Department of Anesthesia and Critical Care, Groupe Hospitalo-Universitaire Assistance Publique-Hôpitaux de Paris Centre-Université de Paris, Hôpital Cochin (C.M.S., N.R.), Unité de Recherche Clinique, Innovation, Pharmacologie, Centre Hospitalier Universitaire de Saint-Etienne, Sainboise INSERM Unité 1059, Université Jean Monnet, and INSERM CIE1408 (S.L., B.D., E.P., P. Mismetti), French Clinical Research Infrastructure Network (F-CRIN), Investigation Network on Venous Thromboembolism (INNOVTE) (S.L., P.G., P. Mismetti), and Institut du Thorax Curie-Montsouris, Institut Mutualiste Montsouris (P.G.), Paris, INSERM Centre National de la Recherche Scientifique 5558, Université Claude Bernard, Université de Lyon, Lyon (M.C.), and the Department of Anesthesia and Critical Care, Polyclinique du Parc, Saint Saulve (D.D.) - all in France; the Department of Anesthesia and Critical Care, University Hospital Doctor Peset, Valencia (J.L.), and the Department of Anesthesia and Critical Care, Hospital Universitario Fundación de Alcorcón, Madrid (J.M.-M.) - both in Spain; Sektionsleiter Endoprothetik, Sana Klinikum Offenbach, Offenbach am Main, Germany (P. Mouret); and McGill University, Montreal (W.F.).'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Girard', 'Affiliation': 'From the Department of Anesthesia and Critical Care, Groupe Hospitalo-Universitaire Assistance Publique-Hôpitaux de Paris Centre-Université de Paris, Hôpital Cochin (C.M.S., N.R.), Unité de Recherche Clinique, Innovation, Pharmacologie, Centre Hospitalier Universitaire de Saint-Etienne, Sainboise INSERM Unité 1059, Université Jean Monnet, and INSERM CIE1408 (S.L., B.D., E.P., P. Mismetti), French Clinical Research Infrastructure Network (F-CRIN), Investigation Network on Venous Thromboembolism (INNOVTE) (S.L., P.G., P. Mismetti), and Institut du Thorax Curie-Montsouris, Institut Mutualiste Montsouris (P.G.), Paris, INSERM Centre National de la Recherche Scientifique 5558, Université Claude Bernard, Université de Lyon, Lyon (M.C.), and the Department of Anesthesia and Critical Care, Polyclinique du Parc, Saint Saulve (D.D.) - all in France; the Department of Anesthesia and Critical Care, University Hospital Doctor Peset, Valencia (J.L.), and the Department of Anesthesia and Critical Care, Hospital Universitario Fundación de Alcorcón, Madrid (J.M.-M.) - both in Spain; Sektionsleiter Endoprothetik, Sana Klinikum Offenbach, Offenbach am Main, Germany (P. Mouret); and McGill University, Montreal (W.F.).'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Llau', 'Affiliation': 'From the Department of Anesthesia and Critical Care, Groupe Hospitalo-Universitaire Assistance Publique-Hôpitaux de Paris Centre-Université de Paris, Hôpital Cochin (C.M.S., N.R.), Unité de Recherche Clinique, Innovation, Pharmacologie, Centre Hospitalier Universitaire de Saint-Etienne, Sainboise INSERM Unité 1059, Université Jean Monnet, and INSERM CIE1408 (S.L., B.D., E.P., P. Mismetti), French Clinical Research Infrastructure Network (F-CRIN), Investigation Network on Venous Thromboembolism (INNOVTE) (S.L., P.G., P. Mismetti), and Institut du Thorax Curie-Montsouris, Institut Mutualiste Montsouris (P.G.), Paris, INSERM Centre National de la Recherche Scientifique 5558, Université Claude Bernard, Université de Lyon, Lyon (M.C.), and the Department of Anesthesia and Critical Care, Polyclinique du Parc, Saint Saulve (D.D.) - all in France; the Department of Anesthesia and Critical Care, University Hospital Doctor Peset, Valencia (J.L.), and the Department of Anesthesia and Critical Care, Hospital Universitario Fundación de Alcorcón, Madrid (J.M.-M.) - both in Spain; Sektionsleiter Endoprothetik, Sana Klinikum Offenbach, Offenbach am Main, Germany (P. Mouret); and McGill University, Montreal (W.F.).'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Mouret', 'Affiliation': 'From the Department of Anesthesia and Critical Care, Groupe Hospitalo-Universitaire Assistance Publique-Hôpitaux de Paris Centre-Université de Paris, Hôpital Cochin (C.M.S., N.R.), Unité de Recherche Clinique, Innovation, Pharmacologie, Centre Hospitalier Universitaire de Saint-Etienne, Sainboise INSERM Unité 1059, Université Jean Monnet, and INSERM CIE1408 (S.L., B.D., E.P., P. Mismetti), French Clinical Research Infrastructure Network (F-CRIN), Investigation Network on Venous Thromboembolism (INNOVTE) (S.L., P.G., P. Mismetti), and Institut du Thorax Curie-Montsouris, Institut Mutualiste Montsouris (P.G.), Paris, INSERM Centre National de la Recherche Scientifique 5558, Université Claude Bernard, Université de Lyon, Lyon (M.C.), and the Department of Anesthesia and Critical Care, Polyclinique du Parc, Saint Saulve (D.D.) - all in France; the Department of Anesthesia and Critical Care, University Hospital Doctor Peset, Valencia (J.L.), and the Department of Anesthesia and Critical Care, Hospital Universitario Fundación de Alcorcón, Madrid (J.M.-M.) - both in Spain; Sektionsleiter Endoprothetik, Sana Klinikum Offenbach, Offenbach am Main, Germany (P. Mouret); and McGill University, Montreal (W.F.).'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Fisher', 'Affiliation': 'From the Department of Anesthesia and Critical Care, Groupe Hospitalo-Universitaire Assistance Publique-Hôpitaux de Paris Centre-Université de Paris, Hôpital Cochin (C.M.S., N.R.), Unité de Recherche Clinique, Innovation, Pharmacologie, Centre Hospitalier Universitaire de Saint-Etienne, Sainboise INSERM Unité 1059, Université Jean Monnet, and INSERM CIE1408 (S.L., B.D., E.P., P. Mismetti), French Clinical Research Infrastructure Network (F-CRIN), Investigation Network on Venous Thromboembolism (INNOVTE) (S.L., P.G., P. Mismetti), and Institut du Thorax Curie-Montsouris, Institut Mutualiste Montsouris (P.G.), Paris, INSERM Centre National de la Recherche Scientifique 5558, Université Claude Bernard, Université de Lyon, Lyon (M.C.), and the Department of Anesthesia and Critical Care, Polyclinique du Parc, Saint Saulve (D.D.) - all in France; the Department of Anesthesia and Critical Care, University Hospital Doctor Peset, Valencia (J.L.), and the Department of Anesthesia and Critical Care, Hospital Universitario Fundación de Alcorcón, Madrid (J.M.-M.) - both in Spain; Sektionsleiter Endoprothetik, Sana Klinikum Offenbach, Offenbach am Main, Germany (P. Mouret); and McGill University, Montreal (W.F.).'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Martínez-Martín', 'Affiliation': 'From the Department of Anesthesia and Critical Care, Groupe Hospitalo-Universitaire Assistance Publique-Hôpitaux de Paris Centre-Université de Paris, Hôpital Cochin (C.M.S., N.R.), Unité de Recherche Clinique, Innovation, Pharmacologie, Centre Hospitalier Universitaire de Saint-Etienne, Sainboise INSERM Unité 1059, Université Jean Monnet, and INSERM CIE1408 (S.L., B.D., E.P., P. Mismetti), French Clinical Research Infrastructure Network (F-CRIN), Investigation Network on Venous Thromboembolism (INNOVTE) (S.L., P.G., P. Mismetti), and Institut du Thorax Curie-Montsouris, Institut Mutualiste Montsouris (P.G.), Paris, INSERM Centre National de la Recherche Scientifique 5558, Université Claude Bernard, Université de Lyon, Lyon (M.C.), and the Department of Anesthesia and Critical Care, Polyclinique du Parc, Saint Saulve (D.D.) - all in France; the Department of Anesthesia and Critical Care, University Hospital Doctor Peset, Valencia (J.L.), and the Department of Anesthesia and Critical Care, Hospital Universitario Fundación de Alcorcón, Madrid (J.M.-M.) - both in Spain; Sektionsleiter Endoprothetik, Sana Klinikum Offenbach, Offenbach am Main, Germany (P. Mouret); and McGill University, Montreal (W.F.).'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Duverger', 'Affiliation': 'From the Department of Anesthesia and Critical Care, Groupe Hospitalo-Universitaire Assistance Publique-Hôpitaux de Paris Centre-Université de Paris, Hôpital Cochin (C.M.S., N.R.), Unité de Recherche Clinique, Innovation, Pharmacologie, Centre Hospitalier Universitaire de Saint-Etienne, Sainboise INSERM Unité 1059, Université Jean Monnet, and INSERM CIE1408 (S.L., B.D., E.P., P. Mismetti), French Clinical Research Infrastructure Network (F-CRIN), Investigation Network on Venous Thromboembolism (INNOVTE) (S.L., P.G., P. Mismetti), and Institut du Thorax Curie-Montsouris, Institut Mutualiste Montsouris (P.G.), Paris, INSERM Centre National de la Recherche Scientifique 5558, Université Claude Bernard, Université de Lyon, Lyon (M.C.), and the Department of Anesthesia and Critical Care, Polyclinique du Parc, Saint Saulve (D.D.) - all in France; the Department of Anesthesia and Critical Care, University Hospital Doctor Peset, Valencia (J.L.), and the Department of Anesthesia and Critical Care, Hospital Universitario Fundación de Alcorcón, Madrid (J.M.-M.) - both in Spain; Sektionsleiter Endoprothetik, Sana Klinikum Offenbach, Offenbach am Main, Germany (P. Mouret); and McGill University, Montreal (W.F.).'}, {'ForeName': 'Béatrice', 'Initials': 'B', 'LastName': 'Deygas', 'Affiliation': 'From the Department of Anesthesia and Critical Care, Groupe Hospitalo-Universitaire Assistance Publique-Hôpitaux de Paris Centre-Université de Paris, Hôpital Cochin (C.M.S., N.R.), Unité de Recherche Clinique, Innovation, Pharmacologie, Centre Hospitalier Universitaire de Saint-Etienne, Sainboise INSERM Unité 1059, Université Jean Monnet, and INSERM CIE1408 (S.L., B.D., E.P., P. Mismetti), French Clinical Research Infrastructure Network (F-CRIN), Investigation Network on Venous Thromboembolism (INNOVTE) (S.L., P.G., P. Mismetti), and Institut du Thorax Curie-Montsouris, Institut Mutualiste Montsouris (P.G.), Paris, INSERM Centre National de la Recherche Scientifique 5558, Université Claude Bernard, Université de Lyon, Lyon (M.C.), and the Department of Anesthesia and Critical Care, Polyclinique du Parc, Saint Saulve (D.D.) - all in France; the Department of Anesthesia and Critical Care, University Hospital Doctor Peset, Valencia (J.L.), and the Department of Anesthesia and Critical Care, Hospital Universitario Fundación de Alcorcón, Madrid (J.M.-M.) - both in Spain; Sektionsleiter Endoprothetik, Sana Klinikum Offenbach, Offenbach am Main, Germany (P. Mouret); and McGill University, Montreal (W.F.).'}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Presles', 'Affiliation': 'From the Department of Anesthesia and Critical Care, Groupe Hospitalo-Universitaire Assistance Publique-Hôpitaux de Paris Centre-Université de Paris, Hôpital Cochin (C.M.S., N.R.), Unité de Recherche Clinique, Innovation, Pharmacologie, Centre Hospitalier Universitaire de Saint-Etienne, Sainboise INSERM Unité 1059, Université Jean Monnet, and INSERM CIE1408 (S.L., B.D., E.P., P. Mismetti), French Clinical Research Infrastructure Network (F-CRIN), Investigation Network on Venous Thromboembolism (INNOVTE) (S.L., P.G., P. Mismetti), and Institut du Thorax Curie-Montsouris, Institut Mutualiste Montsouris (P.G.), Paris, INSERM Centre National de la Recherche Scientifique 5558, Université Claude Bernard, Université de Lyon, Lyon (M.C.), and the Department of Anesthesia and Critical Care, Polyclinique du Parc, Saint Saulve (D.D.) - all in France; the Department of Anesthesia and Critical Care, University Hospital Doctor Peset, Valencia (J.L.), and the Department of Anesthesia and Critical Care, Hospital Universitario Fundación de Alcorcón, Madrid (J.M.-M.) - both in Spain; Sektionsleiter Endoprothetik, Sana Klinikum Offenbach, Offenbach am Main, Germany (P. Mouret); and McGill University, Montreal (W.F.).'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Cucherat', 'Affiliation': 'From the Department of Anesthesia and Critical Care, Groupe Hospitalo-Universitaire Assistance Publique-Hôpitaux de Paris Centre-Université de Paris, Hôpital Cochin (C.M.S., N.R.), Unité de Recherche Clinique, Innovation, Pharmacologie, Centre Hospitalier Universitaire de Saint-Etienne, Sainboise INSERM Unité 1059, Université Jean Monnet, and INSERM CIE1408 (S.L., B.D., E.P., P. Mismetti), French Clinical Research Infrastructure Network (F-CRIN), Investigation Network on Venous Thromboembolism (INNOVTE) (S.L., P.G., P. Mismetti), and Institut du Thorax Curie-Montsouris, Institut Mutualiste Montsouris (P.G.), Paris, INSERM Centre National de la Recherche Scientifique 5558, Université Claude Bernard, Université de Lyon, Lyon (M.C.), and the Department of Anesthesia and Critical Care, Polyclinique du Parc, Saint Saulve (D.D.) - all in France; the Department of Anesthesia and Critical Care, University Hospital Doctor Peset, Valencia (J.L.), and the Department of Anesthesia and Critical Care, Hospital Universitario Fundación de Alcorcón, Madrid (J.M.-M.) - both in Spain; Sektionsleiter Endoprothetik, Sana Klinikum Offenbach, Offenbach am Main, Germany (P. Mouret); and McGill University, Montreal (W.F.).'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Mismetti', 'Affiliation': 'From the Department of Anesthesia and Critical Care, Groupe Hospitalo-Universitaire Assistance Publique-Hôpitaux de Paris Centre-Université de Paris, Hôpital Cochin (C.M.S., N.R.), Unité de Recherche Clinique, Innovation, Pharmacologie, Centre Hospitalier Universitaire de Saint-Etienne, Sainboise INSERM Unité 1059, Université Jean Monnet, and INSERM CIE1408 (S.L., B.D., E.P., P. Mismetti), French Clinical Research Infrastructure Network (F-CRIN), Investigation Network on Venous Thromboembolism (INNOVTE) (S.L., P.G., P. Mismetti), and Institut du Thorax Curie-Montsouris, Institut Mutualiste Montsouris (P.G.), Paris, INSERM Centre National de la Recherche Scientifique 5558, Université Claude Bernard, Université de Lyon, Lyon (M.C.), and the Department of Anesthesia and Critical Care, Polyclinique du Parc, Saint Saulve (D.D.) - all in France; the Department of Anesthesia and Critical Care, University Hospital Doctor Peset, Valencia (J.L.), and the Department of Anesthesia and Critical Care, Hospital Universitario Fundación de Alcorcón, Madrid (J.M.-M.) - both in Spain; Sektionsleiter Endoprothetik, Sana Klinikum Offenbach, Offenbach am Main, Germany (P. Mouret); and McGill University, Montreal (W.F.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1913808']
487,31969652,Effectiveness of a socially adapted intervention in reducing social inequalities in adolescence weight. The PRALIMAP-INÈS school-based mixed trial.,"BACKGROUND


A high prevalence of overweight/obesity among low socioeconomic status adolescents contributes to health inequalities. However, evidence-based interventions for reducing social inequalities in adolescent weight are lacking. We aimed to investigate whether strengthened care management for adolescents with low socioeconomic status has an equivalent effect in reducing overweight as standard care management in adolescents with high status.
METHODS


PRALIMAP-INÈS was a multicentre trial including 35 state-run high and middle schools in the north-eastern France. A population-based sample of 1639 adolescents aged 13-18 years with screened and clinically confirmed overweight/obesity were proposed for inclusion and divided into two groups by the Family Affluence Scale score: advantaged (score > 5), receiving standard care management (A.S) and less-advantaged randomly assigned to two groups (1:2 ratio): standard care management (LA.S) and standard and strengthened care management (LA.S.S). Interventions were based on the proportionate universalism principle: universal standard care for all groups and proportionate care for the LA.S.S group. Main outcome was body mass index z-score (BMIz) assessed before and 1 year after inclusion.
RESULTS


A total of 1419 adolescents were included and 1143 followed up at 1 year: 649 in A.S, 158 in LA.S and 336 in LA.S.S groups. BMIz decreased significantly for boys (-0.11 [95% CI, -0.13 to -0.08]; p < 0.0001) and girls (-0.05 [-0.08 to -0.03]; p < 0.0001). No equivalence between LA.S.S and A.S groups was evidenced. For girls, the trend to superiority for LA.S.S was confirmed by the more favourable change (-0.06 [-0.11 to -0.01]; p = 0.01) observed on superiority analysis, with no differential change for boys (0.02 [-0.03 to 0.08]; p = 0.41).
CONCLUSIONS


A public health school-based intervention using the proportionate universalism principle may be effective in not worsening or even reducing overweight social inequalities in adolescents, especially for girls. Overcoming social barriers may help health professionals dealing with the burden and inequalities of overweight in adolescents.",2020,"BMIz decreased significantly for boys (-0.11 [95% CI, -0.13 to -0.08]; p < 0.0001) and girls (-0.05 [-0.08 to -0.03]; p < 0.0001).","['1639 adolescents aged 13-18 years with screened and clinically confirmed overweight/obesity were proposed for inclusion and divided into two groups by the Family Affluence Scale score: advantaged (score\u2009>\u20095), receiving standard care management (A.S) and less-advantaged randomly assigned to two groups (1:2 ratio', 'overweight in adolescents', '35 state-run high and middle schools in the north-eastern France', '1419 adolescents were included and 1143 followed up at 1 year: 649 in A.S, 158 in LA.S and 336 in LA.S.S groups', 'adolescence weight', 'adolescents with high status', 'adolescents with low socioeconomic status']","['standard care management (LA.S) and standard and strengthened care management (LA.S.S', 'socially adapted intervention', 'strengthened care management']","['BMIz', 'body mass index z-score (BMIz', 'social inequalities']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439084', 'cui_str': '>5 (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0557797', 'cui_str': 'Middle school (environment)'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0086996', 'cui_str': 'Socioeconomic Status'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}]",1639.0,0.048898,"BMIz decreased significantly for boys (-0.11 [95% CI, -0.13 to -0.08]; p < 0.0001) and girls (-0.05 [-0.08 to -0.03]; p < 0.0001).","[{'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Briançon', 'Affiliation': 'University of Lorraine, EA 4360 APEMAC, Nancy Metz, France. serge.briancon@univ-lorraine.fr.'}, {'ForeName': 'Karine', 'Initials': 'K', 'LastName': 'Legrand', 'Affiliation': 'University of Lorraine, EA 4360 APEMAC, Nancy Metz, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Muller', 'Affiliation': 'University of Lorraine, EA 4360 APEMAC, Nancy Metz, France.'}, {'ForeName': 'Johanne', 'Initials': 'J', 'LastName': 'Langlois', 'Affiliation': 'National Conservatory of Arts and Crafts, Nancy, France.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Saez', 'Affiliation': 'University of Lorraine, EA 4360 APEMAC, Nancy Metz, France.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Spitz', 'Affiliation': 'University of Lorraine, EA 4360 APEMAC, Nancy Metz, France.'}, {'ForeName': 'Marie-Hélène', 'Initials': 'MH', 'LastName': 'Quinet', 'Affiliation': 'Local school office of the Nancy-Metz academy, Nancy, France.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Böhme', 'Affiliation': 'Department of endocrinology, diabetology and nutrition, Nancy University Hospital, Nancy, France.'}, {'ForeName': 'Edith', 'Initials': 'E', 'LastName': 'Lecomte', 'Affiliation': 'National Conservatory of Arts and Crafts, Nancy, France.'}, {'ForeName': 'Abdou Y', 'Initials': 'AY', 'LastName': 'Omorou', 'Affiliation': 'University of Lorraine, EA 4360 APEMAC, Nancy Metz, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",International journal of obesity (2005),['10.1038/s41366-020-0520-z']
488,31704437,"Protocol for a systematically-developed, phase I/II, single-blind randomized controlled trial of treadmill walking exercise training effects on cognition and brain function in persons with multiple sclerosis.","Slowed cognitive processing speed (CPS) is a common and debilitating consequence of multiple sclerosis (MS) that is notoriously difficult to treat. As such, we undertook a systematic line of research that indicated that supervised, progressive treadmill walking exercise (TMWX) training might improve CPS and brain functioning among fully-ambulatory persons with MS. The current study will be the first adequately-powered, single-blind randomized controlled trial (RCT) that examines the efficacy of 12-weeks of TMWX training compared with an active control condition on CPS, thalamocortical brain connectivity (based on resting-state fMRI), and exploratory functional outcomes in 88 fully-ambulatory persons with MS who present with slowed CPS. The intervention condition involves supervised, progressive TMWX training 3 times/week over 12-weeks; this initially involves 15-min of light-to-moderate intensity TMWX that progresses up to 40-min of vigorous intensity TMWX. The active control condition involves supervised, minimal intensity, stretching-and-resistance exercise that will be delivered on the same frequency as the intervention condition. The primary study outcomes involve Symbol Digit Modalities Test performance (i.e., CPS) and fMRI-based measures of thalamocortical resting-state functional connectivity. Exploratory study outcomes involve measures of community participation, activities of daily living, quality of life, and functional mobility. All study outcomes will be administered before and after the 12-week study period by treatment-blinded assessors. If successful, the current study will provide the first Class I evidence for the effects of TMWX training as an approach for improving CPS and its neural correlate, and possibly mitigating the impact of slowed CPS on functional outcomes in MS.",2019,"The intervention condition involves supervised, progressive TMWX training 3 times/week over 12-weeks; this initially involves 15-min of light-to-moderate intensity TMWX that progresses up to 40-min of vigorous intensity TMWX.","['persons with multiple sclerosis', '88 fully-ambulatory persons with MS who present with slowed CPS', 'fully-ambulatory persons with MS']","['supervised, progressive treadmill walking exercise (TMWX) training', 'Slowed cognitive processing speed (CPS', 'treadmill walking exercise training', 'TMWX training']","['Symbol Digit Modalities Test performance (i.e., CPS) and fMRI-based measures of thalamocortical resting-state functional connectivity', 'community participation, activities of daily living, quality of life, and functional mobility', 'CPS and brain functioning', 'cognition and brain function']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}]","[{'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C0582591', 'cui_str': 'Processing speed (observable entity)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0451522', 'cui_str': 'Symbol Digit Modalities Test'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0009476', 'cui_str': 'Community Participation'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0034380'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0031843', 'cui_str': 'function'}]",88.0,0.0221623,"The intervention condition involves supervised, progressive TMWX training 3 times/week over 12-weeks; this initially involves 15-min of light-to-moderate intensity TMWX that progresses up to 40-min of vigorous intensity TMWX.","[{'ForeName': 'Brian M', 'Initials': 'BM', 'LastName': 'Sandroff', 'Affiliation': 'Department of Physical Therapy, University of Alabama at Birmingham, Birmingham, AL, USA. Electronic address: sandroff@uab.edu.'}, {'ForeName': 'M David', 'Initials': 'MD', 'LastName': 'Diggs', 'Affiliation': 'Department of Physical Therapy, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Marcas M', 'Initials': 'MM', 'LastName': 'Bamman', 'Affiliation': 'Departments of Cell, Developmental, & Integrative Biology, University of Alabama at Birmingham, Birmingham, AL, USA; Department of Neurology, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Gary R', 'Initials': 'GR', 'LastName': 'Cutter', 'Affiliation': 'Department of Biostatistics, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Jessica F', 'Initials': 'JF', 'LastName': 'Baird', 'Affiliation': 'Department of Physical Therapy, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'C Danielle', 'Initials': 'CD', 'LastName': 'Jones', 'Affiliation': 'Department of Physical Therapy, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Rinker', 'Affiliation': 'Department of Neurology, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Glenn R', 'Initials': 'GR', 'LastName': 'Wylie', 'Affiliation': 'Kessler Foundation, West Orange, NJ, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'DeLuca', 'Affiliation': 'Kessler Foundation, West Orange, NJ, USA.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Motl', 'Affiliation': 'Department of Physical Therapy, University of Alabama at Birmingham, Birmingham, AL, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105878']
489,32212856,Augmenting Computerized Cognitive Training With Vortioxetine for Age-Related Cognitive Decline: A Randomized Controlled Trial.,"OBJECTIVE


Age-related cognitive decline, the deterioration in functions such as memory and executive function, is faced by most older adults and affects function and quality of life. No approved treatments exist for age-related cognitive decline. Computerized cognitive training has been shown to provide consistent albeit modest improvements in cognitive function as measured by neuropsychological testing. Vortioxetine, an antidepressant medication, has putative procognitive and proneuroplastic properties and therefore may be able to augment cognitive training. In this placebo-controlled study, the authors tested the cognitive benefits of vortioxetine added to cognitive training for adults age 65 or older with age-related cognitive decline.
METHODS


After a 2-week lead-in period of cognitive training, 100 participants were randomly assigned to receive either vortioxetine or placebo in addition to cognitive training for 26 weeks. The primary outcome measure was global cognitive performance, assessed by the NIH Toolbox Cognition Battery Fluid Cognition Composite. The secondary outcome measure was functional cognition, assessed by the UCSD Performance-Based Skills Assessment. All participants received motivational messaging and support from study staff to maximize adherence to the training.
RESULTS


Participants who received vortioxetine with cognitive training showed a greater increase in global cognitive performance compared with those who received placebo with cognitive training. This separation was significant at week 12 but not at other assessment time points. Both groups showed improvement in the secondary outcome measure of functional cognition, with no significant difference between groups.
CONCLUSIONS


Vortioxetine may be beneficial for age-related cognitive decline when combined with cognitive training. These findings provide new treatment directions for combating cognitive decline in older adults.",2020,"RESULTS


Participants who received vortioxetine with cognitive training showed a greater increase in global cognitive performance compared with those who received placebo with cognitive training.","['adults age 65 or older with age-related cognitive decline', '100 participants', 'Age-Related Cognitive Decline', 'older adults']","['vortioxetine added to cognitive training', 'Computerized cognitive training', 'Computerized Cognitive Training With Vortioxetine', 'placebo', 'motivational messaging', 'vortioxetine or placebo', 'vortioxetine with cognitive training', 'Vortioxetine']","['cognitive function', 'global cognitive performance, assessed by the NIH Toolbox Cognition Battery Fluid Cognition Composite', 'global cognitive performance', 'functional cognition', 'functional cognition, assessed by the UCSD Performance-Based Skills Assessment']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0236848', 'cui_str': 'Age-related cognitive decline (finding)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C3661282', 'cui_str': 'vortioxetine'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0729447', 'cui_str': 'Battery fluid (substance)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",100.0,0.154771,"RESULTS


Participants who received vortioxetine with cognitive training showed a greater increase in global cognitive performance compared with those who received placebo with cognitive training.","[{'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Lenze', 'Affiliation': ""Healthy Mind Lab, Department of Psychiatry (Lenze, Stevens, Pham, Haddad), Department of Radiology (Shimony), and Division of Biostatistics (Miller), Washington University School of Medicine, St. Louis; Department of Psychology, St. Louis University, St. Louis (Waring); and Department of Psychology, Queen's University, Kingston, Ontario (Bowie).""}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Stevens', 'Affiliation': ""Healthy Mind Lab, Department of Psychiatry (Lenze, Stevens, Pham, Haddad), Department of Radiology (Shimony), and Division of Biostatistics (Miller), Washington University School of Medicine, St. Louis; Department of Psychology, St. Louis University, St. Louis (Waring); and Department of Psychology, Queen's University, Kingston, Ontario (Bowie).""}, {'ForeName': 'Jill D', 'Initials': 'JD', 'LastName': 'Waring', 'Affiliation': ""Healthy Mind Lab, Department of Psychiatry (Lenze, Stevens, Pham, Haddad), Department of Radiology (Shimony), and Division of Biostatistics (Miller), Washington University School of Medicine, St. Louis; Department of Psychology, St. Louis University, St. Louis (Waring); and Department of Psychology, Queen's University, Kingston, Ontario (Bowie).""}, {'ForeName': 'Vy T', 'Initials': 'VT', 'LastName': 'Pham', 'Affiliation': ""Healthy Mind Lab, Department of Psychiatry (Lenze, Stevens, Pham, Haddad), Department of Radiology (Shimony), and Division of Biostatistics (Miller), Washington University School of Medicine, St. Louis; Department of Psychology, St. Louis University, St. Louis (Waring); and Department of Psychology, Queen's University, Kingston, Ontario (Bowie).""}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Haddad', 'Affiliation': ""Healthy Mind Lab, Department of Psychiatry (Lenze, Stevens, Pham, Haddad), Department of Radiology (Shimony), and Division of Biostatistics (Miller), Washington University School of Medicine, St. Louis; Department of Psychology, St. Louis University, St. Louis (Waring); and Department of Psychology, Queen's University, Kingston, Ontario (Bowie).""}, {'ForeName': 'Josh', 'Initials': 'J', 'LastName': 'Shimony', 'Affiliation': ""Healthy Mind Lab, Department of Psychiatry (Lenze, Stevens, Pham, Haddad), Department of Radiology (Shimony), and Division of Biostatistics (Miller), Washington University School of Medicine, St. Louis; Department of Psychology, St. Louis University, St. Louis (Waring); and Department of Psychology, Queen's University, Kingston, Ontario (Bowie).""}, {'ForeName': 'J Philip', 'Initials': 'JP', 'LastName': 'Miller', 'Affiliation': ""Healthy Mind Lab, Department of Psychiatry (Lenze, Stevens, Pham, Haddad), Department of Radiology (Shimony), and Division of Biostatistics (Miller), Washington University School of Medicine, St. Louis; Department of Psychology, St. Louis University, St. Louis (Waring); and Department of Psychology, Queen's University, Kingston, Ontario (Bowie).""}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Bowie', 'Affiliation': ""Healthy Mind Lab, Department of Psychiatry (Lenze, Stevens, Pham, Haddad), Department of Radiology (Shimony), and Division of Biostatistics (Miller), Washington University School of Medicine, St. Louis; Department of Psychology, St. Louis University, St. Louis (Waring); and Department of Psychology, Queen's University, Kingston, Ontario (Bowie).""}]",The American journal of psychiatry,['10.1176/appi.ajp.2019.19050561']
490,32220520,Effect of Progressive Muscle Relaxation Exercise on Postoperative Pain Level in Patients Undergoing Open Renal Surgery: A Nonrandomized Evaluation.,"PURPOSE


To investigate the effect of progressive muscle relaxation (PMR) exercise on pain and vital signs in patients undergoing open renal surgery.
DESIGN


Nonrandomized evaluation with intervention (n = 31) and control (n = 30) groups.
METHODS


In the intervention group, PMR exercise was performed twice daily on postoperative days 0, 1, 2, and 3. Pain severity and vital signs were evaluated 15 minutes after each exercise application.
FINDINGS


The study detected significant differences in the mean visual analog scale pain severity values in the intervention group, who received PMR exercise between 0 and 3 days. The repeated measurements 15 minutes after PMR exercise exhibited a statistically significant (P < .05) decrease in systolic blood pressure values as well as heart and respiratory rates.
CONCLUSIONS


It was determined that PMR decreased the mean postoperative visual analog scale pain scores and vital signs in patients of the intervention group compared with the control group.",2020,It was determined that PMR decreased the mean postoperative visual analog scale pain scores and vital signs in patients of the intervention group compared with the control group.,"['patients undergoing open renal surgery', 'Patients Undergoing Open Renal Surgery']","['progressive muscle relaxation (PMR) exercise', 'Progressive Muscle Relaxation Exercise', 'PMR exercise']","['Pain severity and vital signs', 'mean visual analog scale pain severity values', 'pain and vital signs', 'Postoperative Pain Level', 'systolic blood pressure values', 'heart and respiratory rates', 'mean postoperative visual analog scale pain scores and vital signs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0194053', 'cui_str': 'Kidney operation (procedure)'}]","[{'cui': 'C0004361', 'cui_str': 'Progressive Relaxation'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0518766'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0231832', 'cui_str': 'Respiration Rate'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score (observable entity)'}]",,0.0289078,It was determined that PMR decreased the mean postoperative visual analog scale pain scores and vital signs in patients of the intervention group compared with the control group.,"[{'ForeName': 'Mihriban', 'Initials': 'M', 'LastName': 'Kısaarslan', 'Affiliation': 'Department of Nursing, Akdeniz University Hospital, Antalya, Turkey.'}, {'ForeName': 'Nilgün', 'Initials': 'N', 'LastName': 'Aksoy', 'Affiliation': 'Faculty of Nursing, Akdeniz University, Antalya, Turkey. Electronic address: nilgunmutluaksoy@akdeniz.edu.tr.'}]",Journal of perianesthesia nursing : official journal of the American Society of PeriAnesthesia Nurses,['10.1016/j.jopan.2019.12.003']
491,32170033,Randomised trial of azithromycin to eradicate  Ureaplasma  in preterm infants.,"OBJECTIVE


To test whether azithromycin eradicates  Ureaplasma  from the respiratory tract in preterm infants.
DESIGN


Prospective, phase IIb randomised, double-blind, placebo-controlled trial.
SETTING


Seven level III-IV US, academic, neonatal intensive care units (NICUs).
PATIENTS


Infants 24 0 -28 6  weeks' gestation (stratified 24 0 -26 6 ; 27 0 -28 6  weeks) randomly assigned within 4 days following birth from July 2013 to August 2016.
INTERVENTIONS


Intravenous azithromycin 20 mg/kg or an equal volume of D5W (placebo) every 24 hours for 3 days.
MAIN OUTCOME MEASURES


The primary efficacy outcome was  Ureaplasma -free survival. Secondary outcomes were all-cause mortality,  Ureaplasma  clearance, physiological bronchopulmonary dysplasia (BPD) at 36 weeks' postmenstrual age, comorbidities of prematurity and duration of respiratory support.
RESULTS


One hundred and twenty-one randomised participants (azithromycin: n=60; placebo: n=61) were included in the intent-to-treat analysis (mean gestational age 26.2±1.4 weeks). Forty-four of 121 participants (36%) were  Ureaplasma  positive (azithromycin: n=19; placebo: n=25).  Ureaplasma -free survival was 55/60 (92% (95% CI 82% to 97%)) for azithromycin compared with 37/61 (61% (95% CI 48% to 73%)) for placebo. Mortality was similar comparing the two treatment groups (5/60 (8%) vs 6/61 (10%)). Azithromycin effectively eradicated  Ureaplasma  in all azithromycin-assigned colonised infants, but 21/25 (84%)  Ureaplasma -colonised participants receiving placebo were culture positive at one or more follow-up timepoints. Most of the neonatal mortality and morbidity was concentrated in 21 infants with lower respiratory tract  Ureaplasma  colonisation. In a subgroup analysis, physiological BPD-free survival was 5/10 (50%) (95% CI 19% to 81%) among azithromycin-assigned infants with lower respiratory tract  Ureaplasma  colonisation versus 2/11 (18%) (95% CI 2% to 52%) in placebo-treated infants.
CONCLUSION


A 3-day azithromycin regimen effectively eradicated respiratory tract  Ureaplasma  colonisation in this study.
TRIAL REGISTRATION NUMBER


NCT01778634.",2020,"Azithromycin effectively eradicated  Ureaplasma  in all azithromycin-assigned colonised infants, but 21/25 (84%)  Ureaplasma -colonised participants receiving placebo were culture positive at one or more follow-up timepoints.","['27 0', '21 infants with lower respiratory tract  Ureaplasma  colonisation', 'n=60', 'preterm infants', 'Forty-four of 121 participants (36%) were', 'Seven level III-IV US, academic, neonatal intensive care units (NICUs', 'One hundred and twenty-one randomised participants', 'Infants 24 0']","['azithromycin', 'Azithromycin', 'placebo', 'Intravenous azithromycin 20 mg/kg or an equal volume of D5W (placebo']","['Ureaplasma -free survival', ""cause mortality,  Ureaplasma  clearance, physiological bronchopulmonary dysplasia (BPD) at 36 weeks' postmenstrual age, comorbidities of prematurity and duration of respiratory support"", 'neonatal mortality and morbidity', 'Mortality', 'physiological BPD-free survival']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0282335', 'cui_str': 'Respiratory Tract'}, {'cui': 'C0041944', 'cui_str': 'T-Mycoplasma'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0441927', 'cui_str': 'Level III (tumor staging)'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}]","[{'cui': 'C0041944', 'cui_str': 'T-Mycoplasma'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0006287', 'cui_str': 'Bronchopulmonary Dysplasia'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0728731', 'cui_str': 'Prematurity of fetus (disorder)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0027616', 'cui_str': 'Neonatal Mortality'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",21.0,0.779323,"Azithromycin effectively eradicated  Ureaplasma  in all azithromycin-assigned colonised infants, but 21/25 (84%)  Ureaplasma -colonised participants receiving placebo were culture positive at one or more follow-up timepoints.","[{'ForeName': 'Rose Marie', 'Initials': 'RM', 'LastName': 'Viscardi', 'Affiliation': 'Department of Pediatrics, University of Maryland School of Medicine, Baltimore, Maryland, USA rviscard@som.umaryland.edu.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Terrin', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, University of Maryland School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Laurence S', 'Initials': 'LS', 'LastName': 'Magder', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, University of Maryland School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Natalie L', 'Initials': 'NL', 'LastName': 'Davis', 'Affiliation': 'Department of Pediatrics, University of Maryland Baltimore, Baltimore, Maryland, USA.'}, {'ForeName': 'Susan J', 'Initials': 'SJ', 'LastName': 'Dulkerian', 'Affiliation': 'Department of Pediatrics, University of Maryland School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Ken B', 'Initials': 'KB', 'LastName': 'Waites', 'Affiliation': 'Department of Pathology, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Namasivayam', 'Initials': 'N', 'LastName': 'Ambalavanan', 'Affiliation': 'Department of Pediatrics, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Kaufman', 'Affiliation': 'Department of Pediatrics, University of Virginia School of Medicine, Charlottesville, Virginia, USA.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Donohue', 'Affiliation': 'Department of Pediatrics, Johns Hopkins Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Deborah J', 'Initials': 'DJ', 'LastName': 'Tuttle', 'Affiliation': 'Department of Pediatrics, Christiana Care Health System, Newark, Delaware, USA.'}, {'ForeName': 'Jorn-Hendrik', 'Initials': 'JH', 'LastName': 'Weitkamp', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Hazem E', 'Initials': 'HE', 'LastName': 'Hassan', 'Affiliation': 'University of Maryland School of Pharmacy, Baltimore, Maryland, USA.'}, {'ForeName': 'Natalie D', 'Initials': 'ND', 'LastName': 'Eddington', 'Affiliation': 'University of Maryland School of Pharmacy, Baltimore, Maryland, USA.'}]",Archives of disease in childhood. Fetal and neonatal edition,['10.1136/archdischild-2019-318122']
492,32175647,The effect of colchicine on the echocardiographic constrictive physiology after coronary artery bypass graft surgery.,"BACKGROUND


Constrictive physiology is a transitory condition that could lead to constrictive pericarditis, which is a rare complication after open-heart surgery. Anti-inflammatory drugs like colchicine are recommended for prevention of constrictive pericarditis; however, there is no evidence about the effect of colchicine on constrictive pericarditis. Thus, the aim of this study is to evaluate the preventive effect of colchicine on the incidence of echocardiographic constrictive physiology after open-heart surgery.
METHODS


This was a parallel randomized, double-blind trial. Patients were randomly assigned to receive 1 mg colchicine once-daily from 48 hours before and 0.5 mg twice daily for 5 days after surgery. Primary outcome was the incidence of the constrictive physiology after primary endpoint (1 week after the surgery). The secondary outcome was the primary outcome after secondary endpoint (4 weeks after surgery) plus the new cases of constrictive physiology between the primary and secondary endpoints.
RESULTS


Out of 160 participating patients, the primary outcome occurred in 19 patients (23%) in placebo and 11 (13%) in intervention groups. There was no significant difference between two groups (P = .106). After 4 weeks of follow-up, 19 patients (23%) in placebo and 9 (11%) in intervention groups had constrictive physiology whereas 2 out of 11 patients (18.2%) were recovered. The difference was significant (P = .038). No new case of constrictive physiology occurred between primary and secondary endpoints.
CONCLUSION


Short-term use of colchicine has a preventive effect on reducing constrictive physiology after 1 month of open-heart surgery but not a week after that.",2020,There was no significant difference between two groups (P = .106).,"['after coronary artery bypass graft surgery', '160 participating patients']","['placebo', 'colchicine']","['incidence of the constrictive physiology', 'new cases of constrictive physiology', 'constrictive physiology', 'echocardiographic constrictive physiology']","[{'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0009262', 'cui_str': 'Colchicine'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}]",160.0,0.54559,There was no significant difference between two groups (P = .106).,"[{'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Shojaeifard', 'Affiliation': 'Echocardiography Research Center, Rajaie Cardiovascular Medical and Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Marzieh', 'Initials': 'M', 'LastName': 'Pakbaz', 'Affiliation': 'Department of Cardiovascular Disease, Hazrat-e Rasool General Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Beheshti', 'Affiliation': 'Department of Cardiology, Rajaie Cardiovascular Medical and Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Freidoun', 'Initials': 'F', 'LastName': 'Noohi Bezanjani', 'Affiliation': 'Department of Cardiology, Rajaie Cardiovascular Medical and Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Ahangar', 'Affiliation': 'Department of Cardiology, Mousavi Hospital, School of Medicine, Zanjan University of Medical Sciences, Zanjan, Iran.'}, {'ForeName': 'Sepehr', 'Initials': 'S', 'LastName': 'Gohari', 'Affiliation': 'School of Medicine, Zanjan University of Medical Sciences, Zanjan, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Dehghani Mohammad Abadi', 'Affiliation': 'Shahid Sadoughi Hospital, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Sajad', 'Initials': 'S', 'LastName': 'Erami', 'Affiliation': 'School of Medicine, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}]","Echocardiography (Mount Kisco, N.Y.)",['10.1111/echo.14605']
493,32212765,Children's exposure to spatial language promotes their spatial thinking.,"Does spatial language contribute to the growth of preschool children's spatial skills? Four-year-old children (N = 50) were randomly assigned to a play-only (n = 24) or a spatial-language and play condition (n = 26). Their mental rotation and spatial vocabulary were assessed at baseline and several days after 5 play sessions. Children in the spatial-language condition scored higher at posttest on a mental rotation task than those in the play-only condition. The amount and diversity of experimenter spatial language during the play sessions accounted for a significant amount of the variance on children's posttest mental rotation. Significant gains in mental rotation were replicated in a second study (N = 34) with a broader range of play activities and with children enrolled in Head Start. These results show that the facilitative effects of spatial language on spatial cognition are not restricted to the context in which the spatial language is provided. In particular, 4-year-old children's experience with spatial language during play can transfer to promote their mental rotation. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,Children in the spatial-language condition scored higher at posttest on a mental rotation task than those in the play-only condition.,['Four-year-old children (N = 50'],['spatial-language and play condition'],['mental rotation'],"[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0035868', 'cui_str': 'Rotation'}]",50.0,0.0383604,Children in the spatial-language condition scored higher at posttest on a mental rotation task than those in the play-only condition.,"[{'ForeName': 'Marianella', 'Initials': 'M', 'LastName': 'Casasola', 'Affiliation': 'Department of Human Development.'}, {'ForeName': 'Wendy S', 'Initials': 'WS', 'LastName': 'Wei', 'Affiliation': 'Department of Human Development.'}, {'ForeName': 'Daniel D', 'Initials': 'DD', 'LastName': 'Suh', 'Affiliation': 'Department of Human Development.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Donskoy', 'Affiliation': 'Department of Human Development.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Ransom', 'Affiliation': 'Department of Human Development.'}]",Journal of experimental psychology. General,['10.1037/xge0000699']
494,31640992,The Osteoarthritis Thumb Therapy (OTTER) II Trial: a study protocol for a three-arm multi-centre randomised placebo controlled trial of the clinical effectiveness and efficacy and cost-effectiveness of splints for symptomatic thumb base osteoarthritis.,"INTRODUCTION


The economic cost of osteoarthritis (OA) is high. At least 4.4 million people have hand OA in the UK. Symptomatic thumb base OA affects 20% of people over 55 years, causing more pain, work and functional disability than OA elsewhere in the hand. Most evidence-based guidelines recommend splinting for hand OA. Splints that support or immobilise the thumb base are routinely used despite there being limited evidence on their effectiveness. The potential effects of placebo interventions in OA are acknowledged, but few studies investigate the clinical efficacy of rehabilitation interventions nor the impact of any placebo effects associated with splints.
METHODS AND ANALYSIS


Participants aged 30 years and over with symptomatic thumb base OA will be recruited into the trial from secondary care occupational therapy and physiotherapy centres. Following informed consent, participants will complete a baseline questionnaire and then be randomised into one of three treatment arms: a self-management programme, a self-management programme plus a verum thumb splint or a self-management programme plus a placebo thumb splint. The primary outcome is the Australian Canadian Osteoarthritis Hand Index (AUSCAN) hand pain scale. The study endpoint is 8 weeks after baseline. Baseline assessments will be carried out prior to randomisation and outcomes collected at 4, 8 and 12 weeks. Cost-effectiveness analysis will be conducted and individual qualitative interviews conducted with up to 40 participants after 8 weeks to explore perceptions and outcome expectations of verum and placebo splints and exercise.
ETHICS AND DISSEMINATION


South Central-Oxford C Research Ethics Committee approved this study (16/SC/0188). The findings will be disseminated to health professional conferences, journals and lay publications for patient organisations. The research will contribute to improving the management of thumb base OA and help clinicians and patients make informed decisions about the value of different interventions.
TRIAL REGISTRATION NUMBER


ISRCTN54744256.",2019,"Symptomatic thumb base OA affects 20% of people over 55 years, causing more pain, work and functional disability than OA elsewhere in the hand.",['Participants aged 30 years and over with symptomatic thumb base OA will be recruited into the trial from secondary care occupational therapy and physiotherapy centres'],"['placebo', 'self-management programme, a self-management programme plus a verum thumb splint or a self-management programme plus a placebo thumb splint', 'verum and placebo splints and exercise']","['pain, work and functional disability', 'Australian Canadian Osteoarthritis Hand Index (AUSCAN) hand pain scale']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0040067', 'cui_str': 'Thumb'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3494402', 'cui_str': 'Secondary Care'}, {'cui': 'C1318464', 'cui_str': 'Occupational Therapy'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0040067', 'cui_str': 'Thumb'}, {'cui': 'C0204861', 'cui_str': 'Application of splint (procedure)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0239833', 'cui_str': 'Hand pain (finding)'}, {'cui': 'C0222045'}]",40.0,0.146512,"Symptomatic thumb base OA affects 20% of people over 55 years, causing more pain, work and functional disability than OA elsewhere in the hand.","[{'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Adams', 'Affiliation': 'School of Health Sciences. Faculty of Environment and Life Sciences, University of Southampton, Southampton, UK ja@soton.ac.uk.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Barratt', 'Affiliation': 'School of Health Sciences. Faculty of Environment and Life Sciences, University of Southampton, Southampton, UK.'}, {'ForeName': 'Nigel K', 'Initials': 'NK', 'LastName': 'Arden', 'Affiliation': 'Nuffield Department of Orthopaedics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Barbosa Bouças', 'Affiliation': 'Department of Life Sciences, Brunel University, Uxbridge, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Bradley', 'Affiliation': 'Occupational Therapy Department, Poole Hospital NHS Foundation Trust, Poole, Poole, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Doherty', 'Affiliation': 'Medicine, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Dutton', 'Affiliation': 'CSM, University of Oxford, OXford, UK.'}, {'ForeName': 'Krysia', 'Initials': 'K', 'LastName': 'Dziedzic', 'Affiliation': 'Arthritis Research Campaign National Primary Care Centre, Keele University, Stoke on Trent, Staffordshire, UK.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Gooberman-Hill', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Hislop Lennie', 'Affiliation': 'School of Health Sciences. Faculty of Environment and Life Sciences, University of Southampton, Southampton, UK.'}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Hutt Greenyer', 'Affiliation': 'School of Health Sciences. Faculty of Environment and Life Sciences, University of Southampton, Southampton, UK.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Jansen', 'Affiliation': 'Pulvertaft Hand Centre, Royal Derby Hospital, Derby, UK.'}, {'ForeName': 'Ramon', 'Initials': 'R', 'LastName': 'Luengo-Fernandez', 'Affiliation': 'Health Economics Research Centre, University of Oxford, Oxford, UK.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Meagher', 'Affiliation': 'School of Health Sciences. Faculty of Environment and Life Sciences, University of Southampton, Southampton, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'White', 'Affiliation': 'School of Health Sciences. Faculty of Environment and Life Sciences, University of Southampton, Southampton, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Williams', 'Affiliation': 'Sport, Health Sciences and Social Work Department, Oxford Brookes University, Oxford, UK.'}]",BMJ open,['10.1136/bmjopen-2018-028342']
495,31640993,Using telehealth in motor neuron disease to increase access to specialist multidisciplinary care: a UK-based pilot and feasibility study.,"OBJECTIVES


Care of patients with motor neuron disease (MND) in a specialist, multidisciplinary clinic is associated with improved survival, but access is not universal. We wanted to pilot and establish the feasibility of a definitive trial of a novel telehealth system (Telehealth in Motor neuron disease, TiM) in patients with MND.
DESIGN


An 18-month, single-centre, mixed-methods, randomised, controlled pilot and feasibility study.
INTERVENTION


TiM telehealth plus usual care versus usual care.
SETTING


A specialist MND care centre in the UK.
PARTICIPANTS


Patients with MND and their primary informal carers.
PRIMARY AND SECONDARY OUTCOME MEASURES


Recruitment, retention and data collection rates, clinical outcomes including participant quality of life and anxiety and depression.
RESULTS


Recruitment achieved the target of 40 patients and 37 carers. Participant characteristics reflected those attending the specialist clinic and included those with severe disability and those with limited experience of technology. Retention and data collection was good. Eighty per cent of patients and 82% of carer participants reported outcome measures were completed at 6 months. Using a longitudinal analysis with repeated measures of quality of life (QoL), a sample size of 131 per arm is recommended in a definitive trial. The methods and intervention were acceptable to participants who were highly motivated to participate to research. The low burden of participation and accessibility of the intervention meant barriers to participation were minimal. However, the study highlighted difficulties assessing the associated costs of the intervention, the challenge of recruitment in such a rare disease and the difficulties of producing rigorous evidence of impact in such a complex intervention.
CONCLUSION


A definitive trial of TiM is feasible but challenging. The complexity of the intervention and heterogeneity of the patient population means that a randomised controlled trial may not be the best way to evaluate the further development and implementation of the TiM.
TRIAL REGISTRATION NUMBER


ISRCTN26675465.",2019,"We wanted to pilot and establish the feasibility of a definitive trial of a novel telehealth system (Telehealth in Motor neuron disease, TiM) in patients with MND.
","['patients with motor neuron disease (MND', 'Patients with MND and their primary informal carers', 'patients with MND', '40 patients and 37 carers', 'A specialist MND care centre in the UK']","['TiM telehealth plus usual care versus usual care', 'novel telehealth system (Telehealth', 'TiM']","['Recruitment, retention and data collection rates, clinical outcomes including participant quality of life and anxiety and depression', 'quality of life (QoL']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085084', 'cui_str': 'Motor System Disease'}, {'cui': 'C1319882', 'cui_str': 'Informal carer'}, {'cui': 'C1305660', 'cui_str': 'Carer (occupation)'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]",,0.150901,"We wanted to pilot and establish the feasibility of a definitive trial of a novel telehealth system (Telehealth in Motor neuron disease, TiM) in patients with MND.
","[{'ForeName': 'Esther V', 'Initials': 'EV', 'LastName': 'Hobson', 'Affiliation': 'Sheffield Institute for Translational Neuroscience, University of Sheffield, Sheffield, UK e.hobson@sheffield.ac.uk.'}, {'ForeName': 'Wendy O', 'Initials': 'WO', 'LastName': 'Baird', 'Affiliation': 'School of Health and Related Research, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Bradburn', 'Affiliation': 'Clinical Trials Research Unit, School of Health and Related Research, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Cooper', 'Affiliation': 'Clinical Trials Research Unit, School of Health and Related Research, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Mawson', 'Affiliation': 'School of Health and Related Research, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Quinn', 'Affiliation': 'Sheffield Motor Neurone Disease Association Research Advisory Group, Sheffield, UK.'}, {'ForeName': 'Pamela J', 'Initials': 'PJ', 'LastName': 'Shaw', 'Affiliation': 'Sheffield Institute for Translational Neuroscience, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Walsh', 'Affiliation': 'Sheffield Institute for Translational Neuroscience, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'McDermott', 'Affiliation': 'Sheffield Institute for Translational Neuroscience, University of Sheffield, Sheffield, UK.'}]",BMJ open,['10.1136/bmjopen-2018-028525']
496,31640994,Process evaluation and exploration of telehealth in motor neuron disease in a UK specialist centre.,"OBJECTIVES


To evaluate the processes involved in using a novel digitally enabled healthcare system (telehealth in motor neuron disease (TiM)) in people living with motor neuron disease (MND) and their informal carers. We examined TiM implementation, potential mechanisms of impact and contextual factors that might influence TiM implementation or impact.
DESIGN


An 18-month, single-centre process evaluation within a randomised, pilot and feasibility study.
INTERVENTION


TiM plus usual care versus usual care alone.
SETTING


A specialist UK MND care centre.
PARTICIPANTS


40 patients with MND and 37 primary informal carers.
PRIMARY AND SECONDARY OUTCOME MEASURES


Patient, carer and staff outcomes and experiences using semistructured interviews. Descriptive data on implementation and use of TiM.
RESULTS


The TiM was acceptable and accessible to patients, carers and staff. Intervention uptake and adherence were good: 14 (70%) patients completed a TiM session at least fortnightly. Barriers to TiM use (such as technology experience and disability) were overcome with well-designed technology and face-to-face training. Reported potential benefits of TiM included improved communication and care coordination, reassurance, identification of complications and the potential for TiM to be an alternative or addition to clinic. Benefits depended on patients' current level of needs or disability. The main challenges were the large number of alerts that were generated by TiM, how the clinicians responded to these alerts and the mismatch between patient/carer expectations and nurses actions. This could be improved by better communication systems and adjusting the alerts algorithm.
CONCLUSION


TiM has the potential to facilitate access to specialist care, but further iterative developments to the intervention and process evaluations of the TiM in different services are required.
TRIAL IDENTIFIER NUMBER


ISRCTN26675465.",2019,"Reported potential benefits of TiM included improved communication and care coordination, reassurance, identification of complications and the potential for TiM to be an alternative or addition to clinic.","['40 patients with MND and 37 primary informal carers', 'motor neuron disease in a UK specialist centre', 'A specialist UK MND care centre', 'people living with motor neuron disease (MND) and their informal carers']","['novel digitally enabled healthcare system (telehealth in motor neuron disease (TiM', 'TiM plus usual care versus usual care alone', 'TiM']","[""patients' current level of needs or disability"", 'communication and care coordination, reassurance, identification of complications']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1319882', 'cui_str': 'Informal carer'}, {'cui': 'C0085084', 'cui_str': 'Motor System Disease'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}]","[{'cui': 'C0562342', 'cui_str': 'Empowered (finding)'}, {'cui': 'C0018696', 'cui_str': 'Health Care Systems'}, {'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C0085084', 'cui_str': 'Motor System Disease'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0242414', 'cui_str': 'Coordination (observable entity)'}, {'cui': 'C0020792', 'cui_str': 'Identification'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",40.0,0.0374002,"Reported potential benefits of TiM included improved communication and care coordination, reassurance, identification of complications and the potential for TiM to be an alternative or addition to clinic.","[{'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Hobson', 'Affiliation': 'Sheffield Institute for Translational Neuroscience, University of Sheffield, Sheffield, UK e.hobson@sheffield.ac.uk.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Baird', 'Affiliation': 'School of Health and Related Research, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Bradburn', 'Affiliation': 'Clinical Trials Research Unit, School of Health and Related Research, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Cooper', 'Affiliation': 'Clinical Trials Research Unit, School of Health and Related Research, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Mawson', 'Affiliation': 'School of Health and Related Research, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Quinn', 'Affiliation': 'Sheffield Motor Neurone Disease Association Research Advisory Group, Sheffield, UK.'}, {'ForeName': 'Pamela J', 'Initials': 'PJ', 'LastName': 'Shaw', 'Affiliation': 'Sheffield Institute for Translational Neuroscience, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Walsh', 'Affiliation': 'Sheffield Institute for Translational Neuroscience, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'McDermott', 'Affiliation': 'Sheffield Institute for Translational Neuroscience, University of Sheffield, Sheffield, UK.'}]",BMJ open,['10.1136/bmjopen-2018-028526']
497,32215888,Effect of Intravenous 25OHD Supplementation on Bone Turnover and Inflammation in Prolonged Critically Ill Patients.,"Critically ill patients have low circulating 25-hydroxyvitamin D (25OHD), vitamin D binding protein (DBP), and 1,25-dihydroxyvitamin D [1,25(OH) 2 D]. Low 25OHD is associated with poor outcomes, possibly explained by its effect on bone and immunity. In this prospective, randomized double-blind, placebo-controlled study, we investigated the feasibility of normalizing 25OHD in prolonged (>10 days) critically ill patients and the effects thereof on 1,25(OH) 2 D, bone metabolism, and innate immunity. Twenty-four patients were included and compared with 24 matched healthy subjects. Patients were randomized to either intravenous bolus of 200 μg 25OHD followed by daily infusion of 15 μg 25OHD for 10 days, or to placebo. Parameters of vitamin D, bone and mineral metabolism, and innate immune function were measured. As safety endpoints, ICU length of stay and mortality were registered. Infusion of 25OHD resulted in a sustained increase of serum 25OHD (from median baseline 9.2 -16.1 ng/ml at day 10), which ,  however, remained below normal levels. There was no increase in serum 1,25(OH) 2 D but a slight increase in serum 24,25(OH) 2 D. Mineral homeostasis, innate immunity and clinical safety endpoints were unaffected. Thus, intravenous 25OHD administration during critical illness increased serum 25OHD concentrations, though less than expected from data in healthy subjects, which suggests illness-induced alterations in 25OHD metabolism and/or increased 25OHD distribution volume. The increased serum 25OHD concentrations were not followed by a rise in 1,25(OH) 2 D nor were bone metabolism or innate immunity affected, which suggests that low 25OHD and 1,25OHD levels are part of the adaptive response to critical illness.",2020,"The increased serum 25OHD concentrations were not followed by a rise in 1,25(OH) 2 D nor were bone metabolism or innate immunity affected, which suggests that low 25OHD and 1,25OHD levels are part of the adaptive response to critical illness.","['Twenty-four patients were included and compared with 24 matched healthy subjects', 'healthy subjects', 'Prolonged Critically Ill Patients']","['Intravenous 25OHD Supplementation', 'placebo']","['serum 1,25(OH', 'low circulating 25-hydroxyvitamin D (25OHD), vitamin D binding protein (DBP), and 1,25-dihydroxyvitamin D [1,25(OH) 2 D', 'serum 25OHD concentrations', 'Bone Turnover and Inflammation', 'vitamin D, bone and mineral metabolism, and innate immune function', 'safety endpoints, ICU length of stay and mortality', 'serum 24,25(OH) 2 D. Mineral homeostasis, innate immunity and clinical safety endpoints', 'serum 25OHD']","[{'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0010340', 'cui_str': 'Critically Ill'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0242210', 'cui_str': 'Binding Proteins'}, {'cui': 'C0370232', 'cui_str': '1,25-dihydroxyvitamin D'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0085268', 'cui_str': 'Bone Turnover'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0026162', 'cui_str': 'Minerals'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0019868', 'cui_str': 'Autoregulation'}, {'cui': 'C0020969', 'cui_str': 'Innate Immune Response'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]",24.0,0.33031,"The increased serum 25OHD concentrations were not followed by a rise in 1,25(OH) 2 D nor were bone metabolism or innate immunity affected, which suggests that low 25OHD and 1,25OHD levels are part of the adaptive response to critical illness.","[{'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Ingels', 'Affiliation': 'Clinical Division and Laboratory of Intensive Care Medicine, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Ilse', 'Initials': 'I', 'LastName': 'Vanhorebeek', 'Affiliation': 'Clinical Division and Laboratory of Intensive Care Medicine, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Van Cromphaut', 'Affiliation': 'Clinical Division and Laboratory of Intensive Care Medicine, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Pieter J', 'Initials': 'PJ', 'LastName': 'Wouters', 'Affiliation': 'Clinical Division and Laboratory of Intensive Care Medicine, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Derese', 'Affiliation': 'Clinical Division and Laboratory of Intensive Care Medicine, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Dehouwer', 'Affiliation': 'Clinical Division and Laboratory of Intensive Care Medicine, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Holger Jon', 'Initials': 'HJ', 'LastName': 'Møller', 'Affiliation': 'Department of Clinical Medicine and Clinical Biochemistry, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Troels K', 'Initials': 'TK', 'LastName': 'Hansen', 'Affiliation': 'Department of Clinical Medicine - Steno Diabetes Center Aarhus, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Jaak', 'Initials': 'J', 'LastName': 'Billen', 'Affiliation': 'Laboratory of Clinical and Experimental Endocrinology, Department of Chronic Diseases, KU Leuven, Belgium.'}, {'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'Mathieu', 'Affiliation': 'Laboratory of Clinical and Experimental Endocrinology, Department of Chronic Diseases, KU Leuven, Belgium.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Bouillon', 'Affiliation': 'Laboratory of Clinical and Experimental Endocrinology, Department of Chronic Diseases, KU Leuven, Belgium.'}, {'ForeName': 'Greet', 'Initials': 'G', 'LastName': 'Van den Berghe', 'Affiliation': 'Clinical Division and Laboratory of Intensive Care Medicine, KU Leuven, Leuven, Belgium.'}]",Hormone and metabolic research = Hormon- und Stoffwechselforschung = Hormones et metabolisme,['10.1055/a-1114-6072']
498,32217888,Genetic predictors to acupuncture response for hot flashes: an exploratory study of breast cancer survivors.,"OBJECTIVE


Because hot flashes are a common symptom experienced by women with breast cancer, we sought to explore genetic predictors associated with response to acupuncture for the treatment of hot flashes.
METHODS


Using data from our completed randomized controlled trial (Clinicaltrials.gov identifier: NCT01005108) on hot flashes among breast cancer survivors who provided biomarker collection (N = 108), we extracted and assayed DNA for single nucleotide polymorphisms in genes involved in neurotransmission, thermoregulation, and inflammation (ADORA1, COMT, TCL1A, and TRPV1). For our primary outcome we classified individuals with a 50% or more reduction in their hot flash composite score at the end of treatment as responders. We used Fisher exact test to identify individual and combined single nucleotide polymorphisms associated with treatment response.
RESULTS


Among women (N = 57) who received acupuncture treatment (electro or sham), we found that women who were carriers of at least one of these six genotypes (ADORA1 rs41264025-GA or rs16851029-GG or rs12744240-GT, COMT rs6269-GA, TCL1A rs2369049-GG, and TRPV1 rs8065080-TT) were more likely to respond to acupuncture for hot flashes than noncarriers (70.3% vs 37.5%, P = 0.035). These six genotypes were not associated with response in women (N = 51) who received pharmacological hot flash treatment (gabapentin or placebo pill; 37.5% vs 37.5%, P = 1.0).
CONCLUSIONS


In this exploratory, proof of concept study, we identified six genotypes that may predict response to acupuncture for hot flashes in breast cancer survivors. If confirmed by future studies, these findings may inform the development of personalized acupuncture for managing hot flashes.",2020,"These six genotypes were not associated with response in women (N = 51) who received pharmacological hot flash treatment (gabapentin or placebo pill; 37.5% vs 37.5%, P = 1.0).
","['women', 'breast cancer survivors who provided biomarker collection', 'women with breast cancer', 'breast cancer survivors']","['acupuncture', 'acupuncture treatment (electro or sham', 'pharmacological hot flash treatment (gabapentin or placebo pill', 'six genotypes (ADORA1 rs41264025-GA or rs16851029-GG or rs12744240-GT, COMT rs6269-GA, TCL1A rs2369049-GG, and TRPV1 rs8065080-TT']","['neurotransmission, thermoregulation, and inflammation (ADORA1, COMT, TCL1A, and TRPV1', 'hot flash composite score']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0600644', 'cui_str': 'Collection'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0394664', 'cui_str': 'Acupuncture Treatment'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0205464', 'cui_str': 'Pharmacologic (qualifier value)'}, {'cui': 'C0600142', 'cui_str': 'Hot Flashes'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0060926', 'cui_str': 'gabapentin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0994475', 'cui_str': 'Pill (basic dose form)'}, {'cui': 'C1285573', 'cui_str': 'Genotype determination'}]","[{'cui': 'C0027793', 'cui_str': 'Neural Transmission'}, {'cui': 'C0005905', 'cui_str': 'Thermoregulation'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0600142', 'cui_str': 'Hot Flashes'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.343199,"These six genotypes were not associated with response in women (N = 51) who received pharmacological hot flash treatment (gabapentin or placebo pill; 37.5% vs 37.5%, P = 1.0).
","[{'ForeName': 'Sally A D', 'Initials': 'SAD', 'LastName': 'Romero', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Qing Susan', 'Initials': 'QS', 'LastName': 'Li', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Orlow', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Mithat', 'Initials': 'M', 'LastName': 'Gonen', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Hui-Chun Irene', 'Initials': 'HI', 'LastName': 'Su', 'Affiliation': 'Moores Cancer Center, University of California San Diego, La Jolla, CA.'}, {'ForeName': 'Jun J', 'Initials': 'JJ', 'LastName': 'Mao', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}]","Menopause (New York, N.Y.)",['10.1097/GME.0000000000001545']
499,31908129,Impact of remote monitoring on clinical outcomes for patients with heart failure and atrial fibrillation: results from the REM-HF trial.,"AIMS


Studies of remote monitoring (RM) in heart failure (HF) speculate that patients with atrial fibrillation (AF) derive the greatest benefit. We compared the impact of RM vs. usual care on clinical outcomes for patients with and without AF enrolled in the Remote Management of Heart Failure Using Implanted Electronic Devices (REM-HF) trial.
METHODS AND RESULTS


Rhythm status was available for 1561 patients (94.6%). Three categories were defined based on total AF duration during the first year of follow-up: (i) no AF (n = 1211, 77.6%), (ii) paroxysmal AF (≥6 min to ≤7 days; n = 92, 5.9%), and (iii) persistent/permanent AF (>7 days; n = 258, 16.5%). Clinical activity, mortality, and hospitalisation rates were compared between treatment strategies for each group. RM resulted in a greater volume of clinical activity in patients with any AF, vs. no AF, with the highest per-patient intervention required for patients with persistent/permanent AF. During 2.8 ± 0.8 years of follow-up, RM was not associated with a reduction in all-cause or cardiovascular mortality for patients with AF. However, in patients with persistent/permanent AF, RM conferred an increased risk of recurrent cardiovascular [hazard ratio (HR) 1.40, 95% confidence interval (CI) 1.06-1.85, P = 0.018] and HF-related (HR 2.05, 95% CI 1.14-3.69, P = 0.016) hospitalisations.
CONCLUSION


In patients with HF and a cardiac implanted electronic device, RM generated greater clinical activity for patients with AF, with no associated reduction in mortality, and conversely, greater risk of cardiovascular hospitalisation amongst patients with persistent/permanent AF. RM strategies may vary in their capability to guide HF management; modified approaches may be needed to improve outcomes for HF patients with AF.",2020,"During 2.8 ± 0.8 years of follow-up, RM was not associated with a reduction in all-cause or cardiovascular mortality for patients with AF.","['patients with heart failure and atrial fibrillation', 'HF patients with AF', 'patients with atrial fibrillation (AF', 'patients with and without AF enrolled in the Remote Management of Heart Failure Using Implanted Electronic Devices (REM-HF) trial', 'Rhythm status was available for 1561 patients (94.6']","['remote monitoring (RM', 'RM', 'RM vs. usual care', 'remote monitoring']","['cardiovascular mortality', 'total AF duration', 'clinical activity', 'risk of recurrent cardiovascular [hazard ratio (HR', 'risk of cardiovascular hospitalisation', 'mortality', 'Clinical activity, mortality, and hospitalisation rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0205157', 'cui_str': 'Remote (qualifier value)'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0560134', 'cui_str': 'rem'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0205157', 'cui_str': 'Remote (qualifier value)'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}]",1561.0,0.0651129,"During 2.8 ± 0.8 years of follow-up, RM was not associated with a reduction in all-cause or cardiovascular mortality for patients with AF.","[{'ForeName': 'Rosita', 'Initials': 'R', 'LastName': 'Zakeri', 'Affiliation': 'Imperial College London (Royal Brompton Hospital), London, UK.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Morgan', 'Affiliation': 'Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Phillips', 'Affiliation': 'Wessex Cardiology Centre, University Hospital Southampton, Southampton, UK.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Kitt', 'Affiliation': 'Wessex Cardiology Centre, University Hospital Southampton, Southampton, UK.'}, {'ForeName': 'G Andre', 'Initials': 'GA', 'LastName': 'Ng', 'Affiliation': 'NIHR Leicester Biomedical Research Centre, University of Leicester, Leicester, UK.'}, {'ForeName': 'Janet M', 'Initials': 'JM', 'LastName': 'McComb', 'Affiliation': 'The Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Williams', 'Affiliation': 'Wythenshawe Hospital, Manchester, UK.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Wright', 'Affiliation': 'Liverpool Heart and Chest NHS Foundation Trust, Liverpool, UK.'}, {'ForeName': 'Jaswinder S', 'Initials': 'JS', 'LastName': 'Gill', 'Affiliation': ""Guys and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Seed', 'Affiliation': 'Blackpool Teaching Hospitals NHS Foundation Trust, Lancashire, UK.'}, {'ForeName': 'Klaus K', 'Initials': 'KK', 'LastName': 'Witte', 'Affiliation': 'University of Leeds and Leeds General Infirmary, Leeds, UK.'}, {'ForeName': 'Martin R', 'Initials': 'MR', 'LastName': 'Cowie', 'Affiliation': 'Imperial College London (Royal Brompton Hospital), London, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European journal of heart failure,['10.1002/ejhf.1709']
500,32080847,A brief diversity training: Raising awareness of ingroup privilege to improve attitudes towards disadvantaged outgroups.,"Diversity training is a popular strategy to reduce prejudice within educational settings. However, in practice, diversity training rarely relies on social-psychological theory, and research on its effectiveness in real-world settings is scarce. Previous research regarding diversity training has particularly neglected an important theoretical concept: privilege as the counterpart of discrimination. Therefore, we developed a diversity training aiming to increase awareness of ingroup privilege, using an intersectional approach to teach participants the complex interaction between privilege and oppression. We randomly allocated students of educational science (N = 112) to a repeated-measures (pre-test, post-test, follow-up) control-group design. Compared with the control group, training participants showed a significant increase in awareness of ingroup privilege 1 week after the training, whereas there was no change in awareness of discrimination. Furthermore, increased awareness of ingroup privilege 1 week after the training mediated improved outgroup attitudes (i.e., more positive outgroup feelings towards immigrants and refugees, reduced subtle prejudice towards immigrants and reduced homonegativity) 2 weeks after the training.",2020,"Compared with the control group, training participants showed a significant increase in awareness of ingroup privilege 1 week after the training, whereas there was no change in awareness of discrimination.",[],"['educational science (N\xa0=\u2009112) to a repeated-measures (pre-test, post-test, follow-up) control-group design', 'Diversity training']","['awareness of ingroup privilege', 'outgroup attitudes', 'awareness of discrimination']",[],"[{'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0012632', 'cui_str': 'Discrimination'}]",,0.014682,"Compared with the control group, training participants showed a significant increase in awareness of ingroup privilege 1 week after the training, whereas there was no change in awareness of discrimination.","[{'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Ehrke', 'Affiliation': 'University of Koblenz-Landau, Landau, Germany.'}, {'ForeName': 'Aysan', 'Initials': 'A', 'LastName': 'Ashoee', 'Affiliation': 'University of Koblenz-Landau, Landau, Germany.'}, {'ForeName': 'Melanie C', 'Initials': 'MC', 'LastName': 'Steffens', 'Affiliation': 'University of Koblenz-Landau, Landau, Germany.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Louvet', 'Affiliation': 'University of Strasbourg, Strasbourg, France.'}]",International journal of psychology : Journal international de psychologie,['10.1002/ijop.12665']
501,32107343,Glucocorticoids affect metabolic but not muscle microvascular insulin sensitivity following high versus low salt intake.,"BACKGROUNDSalt-sensitive hypertension is often accompanied by insulin resistance in obese individuals, but the underlying mechanisms are obscure. Microvascular function is known to affect both salt sensitivity of blood pressure and metabolic insulin sensitivity. We hypothesized that excessive salt intake increases blood pressure and decreases insulin-mediated glucose disposal, at least in part by impairing insulin-mediated muscle microvascular recruitment (IMMR).METHODSIn 20 lean and 20 abdominally obese individuals, we assessed mean arterial pressure (MAP; 24-hour ambulatory blood pressure measurements), insulin-mediated whole-body glucose disposal (M/I value; hyperinsulinemic-euglycemic clamp technique), IMMR (contrast-enhanced ultrasound), osmolyte and water balance, and excretion of mineralocorticoids, glucocorticoids, and amino and organic acids after a low- and high-salt diet during 7 days in a randomized, double-blind, crossover design.RESULTSOn a low-, as compared with a high-salt, intake, MAP was lower, M/I value was lower, and IMMR was greater in both lean and abdominally obese individuals. In addition, natural logarithm IMMR was inversely associated with MAP in lean participants on a low-salt diet only. On a high-salt diet, free water clearance decreased, and excretion of glucocorticoids and of amino acids involved in the urea cycle increased.CONCLUSIONOur findings imply that hemodynamic and metabolic changes resulting from alterations in salt intake are not necessarily associated. Moreover, they are consistent with the concept that a high-salt intake increases muscle glucose uptake as a response to high salt-induced, glucocorticoid-driven muscle catabolism to stimulate urea production and thereby renal water conservation.TRIAL REGISTRATIONClinicalTrials.gov, NCT02068781.",2020,"On a low, as compared to a high salt intake, MAP was lower, M/I-value was lower and IMMR was greater in both lean and abdominally obese individuals.","['obese individuals', '20 lean and 20 abdominally obese individuals']","['Glucocorticoids', 'excessive salt intake']","['mean arterial pressure (MAP; 24h ABPM), insulin-mediated whole body glucose disposal (M/I-value; hyperinsulinemic, euglycemic clamp technique), IMMR (contrast enhanced ultrasound), osmolyte and water balance, and excretion of mineralocorticoids, glucocorticoids, and amino and organic acids', 'IMMR', 'excretion of glucocorticoids and of amino acids', 'Ln IMMR', 'blood pressure and decreases insulin-mediated glucose disposal']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C3540778', 'cui_str': 'Glucocorticoids'}, {'cui': 'C0442802', 'cui_str': 'Excessive (qualifier value)'}, {'cui': 'C0036140', 'cui_str': 'Salts'}]","[{'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0024779', 'cui_str': 'Map'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0079318', 'cui_str': 'Glucose Clamp'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C3541395', 'cui_str': 'Mineralocorticoids'}, {'cui': 'C3540778', 'cui_str': 'Glucocorticoids'}, {'cui': 'C3541407', 'cui_str': 'Organic acids'}, {'cui': 'C3539946', 'cui_str': 'Amino acids'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}]",20.0,0.0497281,"On a low, as compared to a high salt intake, MAP was lower, M/I-value was lower and IMMR was greater in both lean and abdominally obese individuals.","[{'ForeName': 'Monica Tj', 'Initials': 'MT', 'LastName': 'Schütten', 'Affiliation': ''}, {'ForeName': 'Yvo Ham', 'Initials': 'YH', 'LastName': 'Kusters', 'Affiliation': ''}, {'ForeName': 'Alfons Jhm', 'Initials': 'AJ', 'LastName': 'Houben', 'Affiliation': ''}, {'ForeName': 'Hanneke E', 'Initials': 'HE', 'LastName': 'Niessen', 'Affiliation': ''}, {'ForeName': 'Jos', 'Initials': 'J', 'LastName': ""Op 't Roodt"", 'Affiliation': ''}, {'ForeName': 'Jean Ljm', 'Initials': 'JL', 'LastName': 'Scheijen', 'Affiliation': ''}, {'ForeName': 'Marjo P', 'Initials': 'MP', 'LastName': 'van de Waardenburg', 'Affiliation': ''}, {'ForeName': 'Casper G', 'Initials': 'CG', 'LastName': 'Schalkwijk', 'Affiliation': ''}, {'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'de Leeuw', 'Affiliation': ''}, {'ForeName': 'Coen DA', 'Initials': 'CD', 'LastName': 'Stehouwer', 'Affiliation': ''}]",JCI insight,['10.1172/jci.insight.127530']
502,32108436,Efficacy and Safety of AbobotulinumtoxinA for the Treatment of Hemiparesis in Adults with Lower Limb Spasticity Previously Treated With Other Botulinum Toxins: A Secondary Analysis of a Randomized Controlled Trial.,"OBJECTIVE


To examine the safety and efficacy of abobotulinumtoxinA in patients previously treated with botulinum toxin type A (BoNT-A) products other than abobotulinumtoxinA.
DESIGN


Secondary analysis from a phase 3, double-blind, single-cycle, randomized, placebo-controlled study.
SETTING


Fifty-two centers (11 countries).
PATIENTS


Adults with spastic hemiparesis were randomized (1:1:1) to receive abobotulinumtoxinA 1000 U, 1500 U, or placebo in their affected lower limb.
MAIN OUTCOME MEASUREMENTS


Muscle tone (6-point Modified Ashworth Scale [MAS], 0-5) for the gastrocnemius-soleus complex (GSC); proportion of MAS responders (≥1-point improvement); angle of catch (X V3  ) and spasticity grade (Y) for the GSC and soleus. Assessments were at weeks 1, 4, and 12 post-injection. Only descriptive statistics are presented.
RESULTS


Of 388 patients, 84 received previous BoNT-A treatment (abobotulinumtoxinA 1000 U: N = 30; abobotulinumtoxinA 1500 U: N = 28; placebo: N = 26). At week 4, mean (SD) changes in MAS score in the GSC were - 0.8 (1.1), -0.9 (1.0), and - 0.4 (0.7) for abobotulinumtoxinA 1000 U, 1500 U, and placebo, respectively. Greater MAS responder rates were observed for abobotulinumtoxinA versus placebo at all time points. Mean (SD) changes (week 4) for abobotulinumtoxinA 1000 U, 1500 U, and placebo for X V3  were: GSC, 8° (21), 6° (10) and 1° (7); soleus, 11° (21), 5° (9) and 0° (8), respectively; for Y: GSC, -0.4 (0.7), -0.6 (0.8) and - 0.0 (0.9); soleus, -0.5 (0.7), -0.5 (0.7) and - 0.1 (0.6), respectively. Safety data and adverse events were consistent with the overall known profile of abobotulinumtoxinA.
CONCLUSIONS


Patients previously treated with other BoNT-As showed improved muscle tone and spasticity at week 4 following abobotulinumtoxinA injection versus placebo. These findings suggest that abobotulinumtoxinA, at the recommended doses, has a good safety and efficacy profile in adults with lower limb spasticity who were previously treated with other BoNT-A products.",2020,Greater MAS responder rates were observed for abobotulinumtoxinA vs placebo at all time points.,"['adults with lower limb spasticity (LLS', '52 centers (11 countries', 'adults with LLS', 'hemiparesis in adults with lower limb spasticity previously treated with', 'patients previously treated with', '388 patients', 'Adults with spastic hemiparesis']","['abobotulinumtoxinA', 'placebo', 'abobotulinumtoxinA injection vs placebo', 'botulinum toxin type A (BoNT-A', 'abobotulinumtoxinA vs placebo', 'abobotulinumtoxinA 1500\u2009U: N\u2009=\u200928; placebo', 'previous BoNT-A treatment (abobotulinumtoxinA 1000\u2009U: N\u2009=\u200930', 'botulinum toxin', 'abobotulinumtoxinA 1000\u2009U, 1500\u2009U or placebo']","['Efficacy and safety', 'Safety data and adverse events', 'Mean (SD) changes', 'Muscle tone (6-point Modified Ashworth Scale [MAS], 0-5) for the gastrocnemius-soleus complex (GSC); proportion of MAS responders (≥1 point improvement); angle of catch (X V3  ) and spasticity grade (Y) for GSC and soleus', 'muscle tone and spasticity', 'Greater MAS responder rates', 'mean (SD) changes in MAS score in GSC']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1271100', 'cui_str': 'Lower limb spasticity'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0457436', 'cui_str': 'Left hemiparesis (disorder)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0154694', 'cui_str': 'Hemiplegia, Spastic'}]","[{'cui': 'C2719424', 'cui_str': 'abobotulinumtoxinA'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0006050', 'cui_str': 'Botulinum Toxin Type A'}, {'cui': 'C2930113', 'cui_str': 'incobotulinumtoxinA'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C0006055', 'cui_str': 'Botulin'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0549465', 'cui_str': 'Muscle tone (observable entity)'}, {'cui': 'C4707572', 'cui_str': 'Modified Ashworth Scale (assessment scale)'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0231617', 'cui_str': 'Catch (finding)'}, {'cui': 'C0026838', 'cui_str': 'Muscle Spasticity'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.582084,Greater MAS responder rates were observed for abobotulinumtoxinA vs placebo at all time points.,"[{'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Esquenazi', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, MossRehab Gait and Motion Analysis Laboratory, Elkins Park, PA, USA.'}, {'ForeName': 'Gaëtan', 'Initials': 'G', 'LastName': 'Stoquart', 'Affiliation': 'Physical and Rehabilitation Medicine Department, Cliniques universitaires Saint-Luc, Catholic University of Louvain, Brussels, Belgium.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hedera', 'Affiliation': 'Department of Neurology, Division of Movement Disorders, Vanderbilt University, Nashville, TN, USA.'}, {'ForeName': 'Luis Jorge', 'Initials': 'LJ', 'LastName': 'Jacinto', 'Affiliation': 'Centro de Medicina de Reabilitação de Alcoitão, Estoril, Estoril, Portugal.'}, {'ForeName': 'Ugo', 'Initials': 'U', 'LastName': 'Dimanico', 'Affiliation': 'Division of Physical Medicine and Rehabilitation, Department of Surgical Sciences, University of Turin, Turin, Italy.'}, {'ForeName': 'Francois', 'Initials': 'F', 'LastName': 'Constant-Boyer', 'Affiliation': 'Unités de Médecine Physique et de Réadaptation, Hôpital Sébastopol, Université de Reims Champagne-Ardenne, Reims, France.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Brashear', 'Affiliation': 'School of Medicine, University of California, Davis, Sacramento, CA.'}, {'ForeName': 'Anne-Sophie', 'Initials': 'AS', 'LastName': 'Grandoulier', 'Affiliation': 'Biostatistics, Ipsen Pharma, Les Ulis, France.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Vilain', 'Affiliation': 'Medical Affairs, Les Ulis, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Picaut', 'Affiliation': 'Medical Affairs, Les Ulis, France.'}, {'ForeName': 'Jean-Michel', 'Initials': 'JM', 'LastName': 'Gracies', 'Affiliation': 'Service de Rééducation Neurolocomotrice, EA 7377 BIOTN, Université Paris-Est, Hospital Albert Chenevier-Henri Mondor, Créteil, France.'}]","PM & R : the journal of injury, function, and rehabilitation",['10.1002/pmrj.12348']
503,31906903,Study protocol for a randomized control trial to investigate the effectiveness of an 8-week mindfulness-integrated cognitive behavior therapy (MiCBT) transdiagnostic group intervention for primary care patients.,"BACKGROUND


Effective transdiagnostic treatments for patients presenting with principal or comorbid symptoms of anxiety and depression enable more efficient provision of mental health care and may be particularly suitable for the varied population seen in primary healthcare settings. Mindfulness-integrated cognitive behavior therapy (MiCBT) is a transdiagnostic intervention that integrates aspects of CBT, including exposure skills targeting avoidance, with training in mindfulness meditation skills adopted from the Vipassana or insight tradition taught by the Burmese teachers U Ba Khin and Goenka. MiCBT is distinguished from both cognitive therapy and mindfulness-based cognitive therapy by the use of a theoretical framework which proposes that the locus of reinforcement of behavior is the interoceptive experience (body sensations) that co-arises with self-referential thinking. Consequently, MiCBT has a strong focus on body scanning to develop interoceptive awareness and equanimity. Designed for clinical purposes, the four-stage systemic approach of MiCBT, comprising intra-personal (Stage 1) exposure (Stage 2), interpersonal (Stage 3), and empathic (Stage 4) skillsets, is a distinguishing feature among other mindfulness-based interventions (MBIs). The aim of this study is to investigate whether and how group MiCBT decreases depression and anxiety symptoms for patients with a range of common mental health conditions.
METHODS


Participants (n = 120) recruited via medical practitioner referral will be randomized to MiCBT or a wait-list control. Inclusion criteria are age 18-75; fluent in English and having a Kessler Psychological Distress Scale (K10) score of 20 or more. The MiCBT treatment group receive an 8-week MiCBT intervention delivered in a private psychology practice. Participants complete a suite of online self-report measures and record the amount of meditation practice undertaken each week. The control group receive usual treatment and complete the measures at the same time points. Primary outcome measures are the Depression Anxiety Stress Scale-21 (DASS-21) and K10. Analysis will use mixed-model repeated measures.
DISCUSSION


The potential ability of MiCBT to provide a comprehensive therapeutic system that is applicable across diagnostic groups would make it an attractive addition to the available MBIs.
TRIAL REGISTRATION


This trial is registered with the Australia and New Zealand Clinical Trials Registry: ACTRN12617000061336; Date of registration: 11th January 2017.",2020,MiCBT is distinguished from both cognitive therapy and mindfulness-based cognitive therapy by the use of a theoretical framework which proposes that the locus of reinforcement of behavior is the interoceptive experience (body sensations) that co-arises with self-referential thinking.,"['primary care patients', 'patients presenting with principal or comorbid symptoms of anxiety and depression', 'patients with a range of common mental health conditions', 'Participants (n\xa0=\u2009120) recruited via medical practitioner referral', 'Inclusion criteria are age 18-75; fluent in English and having a Kessler Psychological Distress Scale (K10) score of 20 or more']","['MiCBT or a wait-list control', 'MiCBT', 'Mindfulness-integrated cognitive behavior therapy (MiCBT', '8-week mindfulness-integrated cognitive behavior therapy (MiCBT) transdiagnostic group intervention', 'MiCBT intervention']","['depression and anxiety symptoms', 'Depression Anxiety Stress Scale-21 (DASS-21) and K10']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0401925', 'cui_str': 'Teaching principal (occupation)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0205214', 'cui_str': 'Common (qualifier value)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C1306754', 'cui_str': 'Medical practitioner (occupation)'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]","[{'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0222045'}]",,0.0452718,MiCBT is distinguished from both cognitive therapy and mindfulness-based cognitive therapy by the use of a theoretical framework which proposes that the locus of reinforcement of behavior is the interoceptive experience (body sensations) that co-arises with self-referential thinking.,"[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Frances', 'Affiliation': 'Southern Synergy, Department of Psychiatry, School of Clinical Sciences at Monash Health, Monash University, Clayton, Victoria, 3800, Australia. sefra3@student.monash.edu.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Shawyer', 'Affiliation': 'Southern Synergy, Department of Psychiatry, School of Clinical Sciences at Monash Health, Monash University, Clayton, Victoria, 3800, Australia.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Cayoun', 'Affiliation': 'Mindfulness-integrated Cognitive Behavior Therapy Institute, Hobart, Tasmania, Australia.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Enticott', 'Affiliation': 'Southern Synergy, Department of Psychiatry, School of Clinical Sciences at Monash Health, Monash University, Clayton, Victoria, 3800, Australia.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Meadows', 'Affiliation': 'Southern Synergy, Department of Psychiatry, School of Clinical Sciences at Monash Health, Monash University, Clayton, Victoria, 3800, Australia.'}]",BMC psychiatry,['10.1186/s12888-019-2411-1']
504,31825895,Conditional disease-free survival in high-risk renal cell carcinoma treated with sunitinib.,"BACKGROUND


Disease-free survival (DFS) did not reflect accurate individual prognosis after initial diagnosis. As conditional DFS (CDFS) could provide dynamic prognostic information, we evaluated CDFS in these patients treated with or without sunitinib.
RESULTS


A total of 1329 patients with median follow-up 6.54 years were enrolled. CDFS improved continuously with disease-free survivorship increasing in both sunitinib and placebo group with minimal difference. In placebo arm, the CDFS of surviving to five year after living 1, 2, 3, and 4 years were 65%, 78%, 87%, and 95% (observed 5-year DFS: 51%). Dynamic changes of HR showed adjuvant sunitinib decrease relapse risks during the first 1.5 years after surgery (P < 0.03).
CONCLUSIONS


Our study provided contemporary data of CDFS and change of relapse HR in high-risk ccRCC patients after adjuvant sunitinib or placebo. The remarkable improvement in CDFS highlighted the importance of disease-free interval as a strong indicator in patient counseling and surveillance planning.
MATERIALS AND METHODS


The primary end point was CDFS and the second end point was smooth hazard ratios (HR) for the prediction of relapses. The differences of conditional survival were compared with the calculation of d value.",2019,"Dynamic changes of HR showed adjuvant sunitinib decrease relapse risks during the first 1.5 years after surgery (P < 0.03).
","['high-risk ccRCC patients after adjuvant sunitinib or', '1329 patients with median follow-up 6.54 years were enrolled']","['placebo', 'sunitinib']","['conditional survival', 'CDFS improved continuously with disease-free survivorship', 'relapse risks', 'CDFS and the second end point was smooth hazard ratios (HR', 'Conditional disease-free survival']","[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0038955'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0205357', 'cui_str': 'Smooth (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}]",1329.0,0.145465,"Dynamic changes of HR showed adjuvant sunitinib decrease relapse risks during the first 1.5 years after surgery (P < 0.03).
","[{'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Shao', 'Affiliation': 'Department of Urology, Fudan University Shanghai Cancer Center, Shanghai 200032, China.'}, {'ForeName': 'Hengchuan', 'Initials': 'H', 'LastName': 'Su', 'Affiliation': 'Department of Urology, Fudan University Shanghai Cancer Center, Shanghai 200032, China.'}, {'ForeName': 'Dingwei', 'Initials': 'D', 'LastName': 'Ye', 'Affiliation': 'Department of Urology, Fudan University Shanghai Cancer Center, Shanghai 200032, China.'}]",Aging,['10.18632/aging.102549']
505,31987796,"Synbiotics Alter Fecal Microbiomes, But Not Liver Fat or Fibrosis, in a Randomized Trial of Patients With Nonalcoholic Fatty Liver Disease.","BACKGROUND & AIMS


Dysbiosis of the intestinal microbiota has been associated with nonalcoholic fatty liver disease (NAFLD). We investigated whether administration of a synbiotic combination of probiotic and prebiotic agents affected liver fat content, biomarkers of liver fibrosis, and the composition of the fecal microbiome in patients with NAFLD.
METHODS


We performed a double-blind phase 2 trial of 104 patients with NAFLD in the United Kingdom. Participants (mean age, 50.8 ± 12.6 years; 65% men; 37% with diabetes) were randomly assigned to groups given the synbiotic agents (fructo-oligosaccharides, 4 g twice per day, plus Bifidobacterium animalis subspecies lactis BB-12; n = 55) or placebo (n = 49) for 10-14 months. Liver fat content was measured at the start and end of the study by magnetic resonance spectroscopy, and liver fibrosis was determined from a validated biomarker scoring system and vibration-controlled transient elastography. Fecal samples were collected at the start and end of the study, the fecal microbiome were analyzed by 16S ribosomal DNA sequencing.
RESULTS


Mean baseline and end-of-study magnetic resonance spectroscopy liver fat percentage values were 32.3% ± 24.8% and 28.5% ± 20.1% in the synbiotic group and 31.3% ± 22% and 25.2% ± 17.2% in the placebo group. In the unadjusted intention-to-treat analysis, we found no significant difference in liver fat reduction between groups (β = 2.8; 95% confidence interval, -2.2 to 7.8; P = .30). In a fully adjusted regression model (adjusted for baseline measurement of the outcome plus age, sex, weight difference, and baseline weight), only weight loss was associated with a significant decrease in liver fat (β = 2; 95% confidence interval, 1.5-2.6; P = .03). Fecal samples from patients who received the synbiotic had higher proportions of Bifidobacterium and Faecalibacterium species, and reductions in Oscillibacter and Alistipes species, compared with baseline; these changes were not observed in the placebo group. Changes in the composition of fecal microbiota were not associated with liver fat or markers of fibrosis.
CONCLUSIONS


In a randomized trial of patients with NAFLD, 1 year of administration of a synbiotic combination (probiotic and prebiotic) altered the fecal microbiome but did not reduce liver fat content or markers of liver fibrosis. (ClinicalTrials.gov, Number: NCT01680640).",2020,"In the unadjusted intention to treat analysis, we found no significant difference in liver fat reduction between groups (β=2.8; 95% CI, -2.2 to 7.8; P=.30).","['Participants (mean age', 'Patients With Non-alcoholic Fatty Liver Disease', '104 patients with NAFLD in the United Kingdom', 'y; 65% men; 37% with diabetes', 'patients with NAFLD, 1 y administration of a', 'patients with NAFLD']","['placebo', 'synbiotic agents (fructo-oligosaccharides, 4 g twice per day, plus Bifidobacterium animalis subsp', 'synbiotic combination of probiotic and prebiotic agents', 'synbiotic combination (probiotic and prebiotic']","['Bifidobacterium and Faecalibacterium, and reductions in Oscillibacter and Alistipes', 'composition of fecal microbiota', 'weight loss', 'liver fat reduction', 'liver fat', 'liver fat or markers of fibrosis', 'liver fat content, biomarkers of liver fibrosis, and the composition of the fecal microbiome', 'Liver fat content', 'Liver Fat or Fibrosis', 'liver fat content or markers of liver fibrosis']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0400966', 'cui_str': 'NAFLD'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2936470', 'cui_str': 'Synbiotics'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C0028959', 'cui_str': 'Oligosaccharides'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C2717875', 'cui_str': 'Prebiotics'}]","[{'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}, {'cui': 'C1229075', 'cui_str': 'Faecalibacterium'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C2288424', 'cui_str': 'Oscillibacter species'}, {'cui': 'C1490417', 'cui_str': 'Alistipes'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0239946', 'cui_str': 'Fibrosis, Liver'}, {'cui': 'C1956108', 'cui_str': 'Microbiome'}]",104.0,0.339403,"In the unadjusted intention to treat analysis, we found no significant difference in liver fat reduction between groups (β=2.8; 95% CI, -2.2 to 7.8; P=.30).","[{'ForeName': 'Eleonora', 'Initials': 'E', 'LastName': 'Scorletti', 'Affiliation': 'Human Development and Health, Faculty of Medicine, University of Southampton, Southampton, United Kingdom; National Institute for Health Research Southampton Biomedical Research Centre, University of Southampton and University Hospital Southampton National Health Service Foundation Trust, Southampton, United Kingdom; Department of Gastroenterology, University of Pennsylvania, Perelman School of Medicine, Philadelphia, Pennsylvania. Electronic address: e.scorletti@soton.ac.uk.'}, {'ForeName': 'Paul R', 'Initials': 'PR', 'LastName': 'Afolabi', 'Affiliation': 'Human Development and Health, Faculty of Medicine, University of Southampton, Southampton, United Kingdom; National Institute for Health Research Southampton Biomedical Research Centre, University of Southampton and University Hospital Southampton National Health Service Foundation Trust, Southampton, United Kingdom.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Miles', 'Affiliation': 'Human Development and Health, Faculty of Medicine, University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'Debbie E', 'Initials': 'DE', 'LastName': 'Smith', 'Affiliation': 'Human Development and Health, Faculty of Medicine, University of Southampton, Southampton, United Kingdom; National Institute for Health Research Southampton Biomedical Research Centre, University of Southampton and University Hospital Southampton National Health Service Foundation Trust, Southampton, United Kingdom.'}, {'ForeName': 'Amal', 'Initials': 'A', 'LastName': 'Almehmadi', 'Affiliation': 'Human Development and Health, Faculty of Medicine, University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'Albandri', 'Initials': 'A', 'LastName': 'Alshathry', 'Affiliation': 'Human Development and Health, Faculty of Medicine, University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'Caroline E', 'Initials': 'CE', 'LastName': 'Childs', 'Affiliation': 'Human Development and Health, Faculty of Medicine, University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Del Fabbro', 'Affiliation': 'Human Development and Health, Faculty of Medicine, University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'Josh', 'Initials': 'J', 'LastName': 'Bilson', 'Affiliation': 'Human Development and Health, Faculty of Medicine, University of Southampton, Southampton, United Kingdom; National Institute for Health Research Southampton Biomedical Research Centre, University of Southampton and University Hospital Southampton National Health Service Foundation Trust, Southampton, United Kingdom.'}, {'ForeName': 'Helen E', 'Initials': 'HE', 'LastName': 'Moyses', 'Affiliation': 'National Institute for Health Research Southampton Biomedical Research Centre, University of Southampton and University Hospital Southampton National Health Service Foundation Trust, Southampton, United Kingdom.'}, {'ForeName': 'Geraldine F', 'Initials': 'GF', 'LastName': 'Clough', 'Affiliation': 'Human Development and Health, Faculty of Medicine, University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'Jaswinder K', 'Initials': 'JK', 'LastName': 'Sethi', 'Affiliation': 'Human Development and Health, Faculty of Medicine, University of Southampton, Southampton, United Kingdom; National Institute for Health Research Southampton Biomedical Research Centre, University of Southampton and University Hospital Southampton National Health Service Foundation Trust, Southampton, United Kingdom; Institute for Life Sciences, University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'Janisha', 'Initials': 'J', 'LastName': 'Patel', 'Affiliation': 'Hepatology, Department of Medicine, University Hospital Southampton National Health Service (NHS) Foundation Trust, Southampton, United Kingdom.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Wright', 'Affiliation': 'Hepatology, Department of Medicine, University Hospital Southampton National Health Service (NHS) Foundation Trust, Southampton, United Kingdom.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Breen', 'Affiliation': 'Department of Radiology, University Hospital Southampton National Health Service (NHS) Foundation Trust, Southampton, United Kingdom.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Peebles', 'Affiliation': 'Department of Radiology, University Hospital Southampton National Health Service (NHS) Foundation Trust, Southampton, United Kingdom.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Darekar', 'Affiliation': 'Department of Medical Physics, University Hospital Southampton National Health Service (NHS) Foundation Trust, Southampton, United Kingdom.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Aspinall', 'Affiliation': 'Department of Hepatology, Portsmouth Hospitals National Health Service (NHS) Trust, Queen Alexandra Hospital, Portsmouth, United Kingdom.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Fowell', 'Affiliation': 'Department of Hepatology, Portsmouth Hospitals National Health Service (NHS) Trust, Queen Alexandra Hospital, Portsmouth, United Kingdom.'}, {'ForeName': 'Joanna K', 'Initials': 'JK', 'LastName': 'Dowman', 'Affiliation': 'Department of Hepatology, Portsmouth Hospitals National Health Service (NHS) Trust, Queen Alexandra Hospital, Portsmouth, United Kingdom.'}, {'ForeName': 'Valerio', 'Initials': 'V', 'LastName': 'Nobili', 'Affiliation': 'Hepatology, Gastroenterology and Nutrition Unit, Istituto di Ricovero e Cura a Carattere Scientifico ""Bambino Gesù"" Children\'s Hospital, Rome, Italy; Department of Pediatric, University ""La Sapienza"", Rome, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Targher', 'Affiliation': 'Section of Endocrinology, Diabetes and Metabolism, Department of Medicine, University and Azienda Ospedaliera Universitaria Integrata of Verona, Verona, Italy.'}, {'ForeName': 'Nathalie M', 'Initials': 'NM', 'LastName': 'Delzenne', 'Affiliation': 'Metabolism and Nutrition Research Group, Louvain Drug Research Institute, Université catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Laure B', 'Initials': 'LB', 'LastName': 'Bindels', 'Affiliation': 'Metabolism and Nutrition Research Group, Louvain Drug Research Institute, Université catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Philip C', 'Initials': 'PC', 'LastName': 'Calder', 'Affiliation': 'Human Development and Health, Faculty of Medicine, University of Southampton, Southampton, United Kingdom; National Institute for Health Research Southampton Biomedical Research Centre, University of Southampton and University Hospital Southampton National Health Service Foundation Trust, Southampton, United Kingdom; Institute for Life Sciences, University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Byrne', 'Affiliation': 'Human Development and Health, Faculty of Medicine, University of Southampton, Southampton, United Kingdom; National Institute for Health Research Southampton Biomedical Research Centre, University of Southampton and University Hospital Southampton National Health Service Foundation Trust, Southampton, United Kingdom.'}]",Gastroenterology,['10.1053/j.gastro.2020.01.031']
506,31111591,"Cost-effectiveness of electronic- and clinician-delivered screening, brief intervention and referral to treatment for women in reproductive health centers.","AIMS


To determine the cost-effectiveness of electronic- and clinician-delivered SBIRT (Screening, Brief Intervention and Referral to Treatment) for reducing primary substance use among women treated in reproductive health centers.
DESIGN


Cost-effectiveness analysis based on a randomized controlled trial.
SETTING


New Haven, CT, USA.
PARTICIPANTS


A convenience sample of 439 women seeking routine care in reproductive health centers who used cigarettes, risky amounts of alcohol, illicit drugs or misused prescription medication.
INTERVENTIONS


Participants were randomized to enhanced usual care (EUC, n = 151), electronic-delivered SBIRT (e-SBIRT, n = 143) or clinician-delivered SBIRT (SBIRT, n = 145).
MEASUREMENTS


The primary outcome was days of primary substance abstinence during the 6-month follow-up period. To account for the possibility that patients might substitute a different drug for their primary substance during the 6-month follow-up period, we also considered the number of days of abstinence from all substances. Incremental cost-effectiveness ratios and cost-effectiveness acceptability curves determined the relative cost-effectiveness of the three conditions from both the clinic and patient perspectives.
FINDINGS


From a health-care provider perspective, e-SBIRT is likely (with probability greater than 0.5) to be cost-effective for any willingness-to-pay value for an additional day of primary-substance abstinence and an additional day of all-substance abstinence. From a patient perspective, EUC is most likely to be the cost-effective intervention when the willingness to pay for an additional day of abstinence (both primary-substance and all-substance) is less than $0.18 and e-SBIRT is most likely to be the cost-effective intervention when the willingness to pay for an additional day of abstinence (both primary-substance and all-substance) is greater than $0.18.
CONCLUSIONS


e-SBIRT could be a cost-effective approach, from both health-care provider and patient perspectives, for use in reproductive health centers to help women reduce substance misuse.",2019,"FINDINGS


From a health-care provider perspective, e-SBIRT is likely (with probability greater than 0.5) to be cost-effective for any willingness-to-pay value for an additional day of primary-substance abstinence and an additional day of all-substance abstinence.","['A convenience sample of 439 women seeking routine care in reproductive health centers who used cigarettes, risky amounts of alcohol, illicit drugs or misused prescription medication', 'women treated in reproductive health centers', 'women in reproductive health centers', 'New Haven, CT, USA']","['electronic- and clinician-delivered SBIRT (Screening, Brief Intervention and Referral to Treatment', 'enhanced usual care (EUC, n\xa0=\xa0151), electronic-delivered SBIRT (e-SBIRT, n\xa0=\xa0143) or clinician-delivered SBIRT (SBIRT, n\xa0=\xa0145', 'electronic- and clinician-delivered screening, brief intervention']","['primary substance abstinence', 'Incremental cost-effectiveness ratios and cost-effectiveness acceptability curves']","[{'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0242667', 'cui_str': 'Reproductive Health'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C1265611', 'cui_str': 'Quantity finding'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0086190', 'cui_str': 'Illicit Drugs'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}]","[{'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4517573', 'cui_str': 'One hundred and forty-three'}, {'cui': 'C4517577', 'cui_str': '145'}]","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0439861', 'cui_str': 'Substance (substance)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}]",439.0,0.110176,"FINDINGS


From a health-care provider perspective, e-SBIRT is likely (with probability greater than 0.5) to be cost-effective for any willingness-to-pay value for an additional day of primary-substance abstinence and an additional day of all-substance abstinence.","[{'ForeName': 'Todd A', 'Initials': 'TA', 'LastName': 'Olmstead', 'Affiliation': 'Lyndon B. Johnson School of Public Affairs, The University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Yonkers', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Ondersma', 'Affiliation': 'Department of Psychiatry and Behavioral Neurosciences and Merrill-Palmer Skillman Institute, Wayne State University, Detroit, MI, USA.'}, {'ForeName': 'Ariadna', 'Initials': 'A', 'LastName': 'Forray', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Gilstad-Hayden', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Martino', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.'}]","Addiction (Abingdon, England)",['10.1111/add.14668']
507,31499228,Communication and coping intervention for mothers of adolescents with type 1 diabetes: Rationale and trial design.,"Mothers of adolescents with type 1 diabetes (T1D) experience high rates of depressive symptoms and diabetes distress, which are established risk factors for deteriorating glycemic control, problems with adherence, increased depressive symptoms, and poor quality of life in adolescents. Given that adolescents are a high-risk population for suboptimal glycemic control, novel interventions to improve outcomes in adolescents with T1D are needed. Building on effective interventions to treat depression in adults, and our own pilot work in this population, we developed a cognitive behavioral intervention, Communication & Coping, to target maternal depressive symptoms and parenting behaviors. The randomized controlled trial compares the telephone and Facebook-delivered Communication & Coping intervention, which promotes the use of adaptive coping strategies and positive parenting practices, to a diabetes education control condition on diabetes outcomes and psychosocial outcomes in adolescents with T1D. This paper describes the study rationale, trial design, and methodology.",2019,"The randomized controlled trial compares the telephone and Facebook-delivered Communication & Coping intervention, which promotes the use of adaptive coping strategies and positive parenting practices, to a diabetes education control condition on diabetes outcomes and psychosocial outcomes in adolescents with T1D.","['adolescents with T1D', 'Mothers of adolescents with type 1 diabetes (T1D) experience high rates of depressive symptoms and diabetes distress', 'adolescents', 'mothers of adolescents with type 1 diabetes']","['telephone and Facebook-delivered Communication & Coping intervention', 'adaptive coping strategies and positive parenting practices, to a diabetes education control condition', 'Communication and coping intervention']",[],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]",[],,0.0392277,"The randomized controlled trial compares the telephone and Facebook-delivered Communication & Coping intervention, which promotes the use of adaptive coping strategies and positive parenting practices, to a diabetes education control condition on diabetes outcomes and psychosocial outcomes in adolescents with T1D.","[{'ForeName': 'Sarah S', 'Initials': 'SS', 'LastName': 'Jaser', 'Affiliation': 'Vanderbilt University Medical Center, USA. Electronic address: sarah.jaser@vumc.org.'}, {'ForeName': 'Emily R', 'Initials': 'ER', 'LastName': 'Hamburger', 'Affiliation': 'Vanderbilt University Medical Center, USA.'}, {'ForeName': 'Sherry', 'Initials': 'S', 'LastName': 'Pagoto', 'Affiliation': 'University of Connecticut, USA.'}, {'ForeName': 'Rodayne', 'Initials': 'R', 'LastName': 'Williams', 'Affiliation': 'Vanderbilt University Medical Center, USA.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Meyn', 'Affiliation': 'Vanderbilt University Medical Center, USA.'}, {'ForeName': 'Abigail C', 'Initials': 'AC', 'LastName': 'Jones', 'Affiliation': 'Vanderbilt University Medical Center, USA.'}, {'ForeName': 'Jill H', 'Initials': 'JH', 'LastName': 'Simmons', 'Affiliation': 'Vanderbilt University Medical Center, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105844']
508,31564451,Home-based records and vaccination appointment stickers as parental reminders to reduce vaccination dropout in Indonesia: A cluster-randomized controlled trial.,"INTRODUCTION


Limited evidence is available about the effectiveness of strategies to remind caregivers when to bring children back for future vaccinations in low- and middle-income country settings. We evaluated the effectiveness of two reminder strategies based on home-based vaccination records (HBR) in Indonesia.
METHODS


In this cluster-randomized controlled trial involving 3616 children <1 year of age, 90 health facilities were randomly assigned to either a control group or one of two intervention groups: (1) HBR-only group, where healthcare workers provided an HBR to any child without an HBR during a vaccination visit and instructed the caregiver to keep it at home between visits, or (2) HBR + sticker group, where, in addition to HBR provision, healthcare workers placed vaccination appointment reminder stickers on the HBR. The primary outcome was receipt of the third dose of diphtheria-tetanus-pertussis-containing vaccine (DTPcv3) within 7 months and the secondary outcome was receipt of a timely DTPcv3 dose.
RESULTS


Control group DTPcv3 coverage was 81%. In intention-to-treat analysis, neither intervention group had significantly different DTPcv3 coverage compared with the control group (RR = 0.94, 95% confidence interval [CI] 0.87; 1.02 for HBR-only group; RR = 0.97, 95% CI 0.90; 1.04 for HBR + sticker group) by study end. However, children in the HBR + sticker group were 50% more likely to have received a DTPcv3 vaccination (RR = 1.46, 95% CI 1.02, 2.09) within 60 days of DTPcv1 vaccination, compared with children in the control group; children in the HBR-only group were not more likely to have done so (RR = 1.05, 95% CI 0.71, 1.55).
DISCUSSION


Reminder stickers had an immediate effect on coverage by improving the proportion of children who received a timely DTPcv3 dose but no effect on the proportion who received DTPcv3 after 7 months. Coupling reminder stickers with strategies to address other reasons why children do not return for vaccination visits should be further explored.",2019,"In intention-to-treat analysis, neither intervention group had significantly different DTPcv3 coverage compared with the control group (RR = 0.94, 95% confidence interval [CI] 0.87; 1.02 for HBR-only group; RR = 0.97, 95% CI 0.90; 1.04 for HBR + sticker group) by study end.","['3616 children <1\u202fyear of age, 90 health facilities']","['HBR-only group, where healthcare workers provided an HBR to any child without an HBR during a vaccination visit and instructed the caregiver to keep it at home between visits, or (2) HBR\u202f+\u202fsticker group']","['DTPcv3 coverage', 'receipt of the third dose of diphtheria-tetanus-pertussis-containing vaccine (DTPcv3', 'DTPcv3 vaccination', 'receipt of a timely DTPcv3 dose']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0018704', 'cui_str': 'Health Facilities'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0018724', 'cui_str': 'Healthcare Workers'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}]","[{'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0012546', 'cui_str': 'Corynebacterium diphtheriae Infection'}, {'cui': 'C0043167', 'cui_str': 'Pertussis'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]",3616.0,0.191243,"In intention-to-treat analysis, neither intervention group had significantly different DTPcv3 coverage compared with the control group (RR = 0.94, 95% confidence interval [CI] 0.87; 1.02 for HBR-only group; RR = 0.97, 95% CI 0.90; 1.04 for HBR + sticker group) by study end.","[{'ForeName': 'Aaron S', 'Initials': 'AS', 'LastName': 'Wallace', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA 30322, United States; Global Immunization Division, United States Centers for Disease Control and Prevention, Atlanta, GA, 30333, United States. Electronic address: awallace@cdc.gov.'}, {'ForeName': 'Kenny', 'Initials': 'K', 'LastName': 'Peetosutan', 'Affiliation': 'Maternal and Child Health Team, UNICEF, Jakarta, Indonesia.'}, {'ForeName': 'Andi', 'Initials': 'A', 'LastName': 'Untung', 'Affiliation': 'Health Communications Team, Ministry of Health, Jakarta, Indonesia.'}, {'ForeName': 'Marisa', 'Initials': 'M', 'LastName': 'Ricardo', 'Affiliation': 'Maternal and Child Health Team, UNICEF, Addis Ababa, Ethiopia.'}, {'ForeName': 'Prima', 'Initials': 'P', 'LastName': 'Yosephine', 'Affiliation': 'National Immunization Program, Ministry of Health, Jakarta, Indonesia.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Wannemuehler', 'Affiliation': 'Global Immunization Division, United States Centers for Disease Control and Prevention, Atlanta, GA, 30333, United States.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Brown', 'Affiliation': 'Brown Consulting Group International LLC, Cornelius, NC, 28031, United States.'}, {'ForeName': 'Deborah A', 'Initials': 'DA', 'LastName': 'McFarland', 'Affiliation': 'Department of Global Health, Rollins School of Public Health, Emory University, Atlanta, GA 30322, United States.'}, {'ForeName': 'Walter A', 'Initials': 'WA', 'LastName': 'Orenstein', 'Affiliation': 'Division of Infectious Diseases, School of Medicine, Emory University, Atlanta, GA 30322, United States.'}, {'ForeName': 'Eli S', 'Initials': 'ES', 'LastName': 'Rosenberg', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, University at Albany, State University of New York, Albany 12222, United States.'}, {'ForeName': 'Saad B', 'Initials': 'SB', 'LastName': 'Omer', 'Affiliation': 'Department of Global Health, Rollins School of Public Health, Emory University, Atlanta, GA 30322, United States.'}, {'ForeName': 'Danni', 'Initials': 'D', 'LastName': 'Daniels', 'Affiliation': 'Global Immunization Division, United States Centers for Disease Control and Prevention, Atlanta, GA, 30333, United States.'}]",Vaccine,['10.1016/j.vaccine.2019.09.040']
509,31100713,"Assessment of an electronic and clinician-delivered brief intervention on cigarette, alcohol and illicit drug use among women in a reproductive healthcare clinic.","BACKGROUND


Women are at highest risk for development of a substance use disorder during their reproductive years. We recently evaluated the efficacy of an electronic screening, brief intervention and referral to treatment (e-SBIRT) and a clinician-delivered SBIRT (SBIRT) compared with enhanced usual care (EUC) for reducing overall substance use among women recruited from reproductive health clinics. The present study assessed the impact of the SBIRT interventions within three primary substance subgroups: cigarettes, illicit drugs, and alcohol.
METHODS


This is a secondary analysis from a 3-group randomized trial comparing e-SBIRT and SBIRT to EUC. For the present study, participants (N = 439) were grouped according to their primary substance: cigarettes, alcohol, or illicit drugs. Differences in days per month of primary substance use over time between treatment groups were examined using generalized estimating equations, modelling linear as well as quadratic effects of time.
RESULTS


Cigarettes were the most frequently reported primary substance (n = 251), followed by illicit drugs (n = 137) and alcohol (n = 51). For primary cigarette use the interaction between the linear effect of time and treatment was significant for SBIRT (β (SE) = -0.067 (0.029), p = .020), but not e-SBIRT, suggesting greater reductions in cigarette use over the first 3 months following treatment with SBIRT compared to EUC. However, the significant interaction of SBIRT with time-squared (β (SE) = 0.009 (0.004), p = .049) showed that reductions in cigarette use attenuated over time, such that after month 3, monthly reductions in cigarette use were similar between groups. Results followed a similar pattern for primary illicit drug use among the e-SBIRT group in which the interaction of e-SBIRT treatment with linear time (β (SE) = -0.181 (0.085), p = .033) and quadratic time (β (SE) = 0.028 (0.012), p = .018) were statistically significant suggesting greater reductions in illicit drug use with e-SBIRT versus EUC, which attenuated with time. Neither SBIRT nor e-SBIRT was associated with a significant reduction in days of alcohol use per month, as compared to EUC.
CONCLUSIONS


Reproductive-age women appear to respond differently to electronic- and clinician-delivered interventions, depending on their primary substance. SBIRT reduced use of cigarettes, and e-SBIRT reduced illicit drug use. Although neither intervention reduced primary alcohol use, the sample size was small (n = 51), suggesting a need for further testing in a larger sample.",2019,"Neither SBIRT nor e-SBIRT was associated with a significant reduction in days of alcohol use per month, as compared to EUC.
","['women recruited from reproductive health clinics', 'Reproductive-age women', 'participants (N\u202f=\u202f439) were grouped according to their primary substance: cigarettes, alcohol, or illicit drugs', 'within three primary substance subgroups: cigarettes, illicit drugs, and alcohol', 'women in a reproductive healthcare clinic']","['SBIRT interventions', 'electronic and clinician-delivered brief intervention', 'electronic screening, brief intervention and referral to treatment (e-SBIRT) and a clinician-delivered SBIRT (SBIRT) compared with enhanced usual care (EUC']",['quadratic time'],"[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0242667', 'cui_str': 'Reproductive Health'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439861', 'cui_str': 'Substance (substance)'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0086190', 'cui_str': 'Illicit Drugs'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}]","[{'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}]",439.0,0.0284338,"Neither SBIRT nor e-SBIRT was associated with a significant reduction in days of alcohol use per month, as compared to EUC.
","[{'ForeName': 'Ariadna', 'Initials': 'A', 'LastName': 'Forray', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, United States of America. Electronic address: ariadna.forray@yale.edu.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Martino', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, United States of America; VA Connecticut Healthcare System, West Haven, CT, United States of America.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Gilstad-Hayden', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, United States of America.'}, {'ForeName': 'Trace', 'Initials': 'T', 'LastName': 'Kershaw', 'Affiliation': 'Division of Chronic Disease, Yale University School of Epidemiology and Public Health, New Haven, CT, United States of America.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Ondersma', 'Affiliation': 'Wayne State University, Department of Psychiatry & Behavioral Neurosciences, & Merrill-Palmer Skillman Institute, Detroit, MI, United States of America.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Olmstead', 'Affiliation': 'Lyndon B Johnson School of Public Affairs, University of Texas - Austin, Austin, TX, United States of America.'}, {'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Yonkers', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, United States of America; Department of Obstetrics, Gynecology, & Reproductive Sciences, Yale University School of Medicine, New Haven, CT, United States of America; Division of Chronic Disease, Yale University School of Epidemiology and Public Health, New Haven, CT, United States of America.'}]",Addictive behaviors,['10.1016/j.addbeh.2019.05.007']
510,32211798,Circulating Insulin-Like Growth Factor-1 Is Positively Associated with Growth and Cognition in 6- to 9-Year-Old Schoolchildren from Ghana.,"BACKGROUND


Milk intake stimulates linear growth and improves cognition in children from low-income countries. These effects may be mediated through insulin-like growth factor-1 (IGF-1).
OBJECTIVE


The objective was to assess the effect of milk supplement on circulating IGF-1 and to assess IGF-1 as a correlate of growth and cognition in children.
METHODS


Secondary data on blood spot IGF-1 from a randomized, double-blind, controlled trial in 6-9-y-old children from rural Ghana were analyzed. Intervention groups received porridge with non-energy-balanced supplements: 8.8 g milk protein/d, 100 kcal/d (Milk8); 4.4 g milk and 4.4 g rice protein/d, 100 kcal/d (Milk/rice); 4.4 g milk protein/d, 48 kcal/d (Milk4); or a control (no protein, 10 kcal/d). IGF-1, length, body composition, and Cambridge Neuropsychological Test Automated Battery (CANTAB) were measured at 3.5 or 8.5 mo. Linear regressions were used to assess the effect of milk interventions on IGF-1 and IGF-1 as a correlate of growth and cognition.
RESULTS


The increase in IGF-1 was 15.3 (95% CI: 3.3, 27.3) ng/mL higher in children receiving Milk8 compared with the control. The IGF-1 increases in the isonitrogenous, isoenergetic Milk/rice or the Milk4 groups were not different from the control (P ≥ 0.49). The increase in IGF-1 was associated with improvements in 4 out of 5 CANTAB domains. The strongest associations included reductions in ""mean correct latency"" from Pattern Recognition Memory and ""pre-extradimensional (pre-ED) shift errors"" from Intra/Extradimensional Set Shift (P ≤ 0.005). In addition, change in IGF-1 was positively associated with changes in height, weight, and fat-free mass (P ≤ 0.001).
CONCLUSIONS


Intake of skimmed milk powder corresponding to one, but not half a glass of milk on school days stimulates IGF-1 in 6-9-y-old Ghanian children. IGF-1 seems to mediate the effect of milk intake on growth and cognition. The association between IGF-1 and cognition in relation to milk intake is novel and opens possibilities for dietary interventions to improve cognition.",2020,"The increase in IGF-1 was 15.3 (95% CI: 3.3, 27.3)","['6-9-y-old children from rural Ghana were analyzed', 'children', 'children from low-income countries']","['porridge with non-energy-balanced supplements: 8.8\xa0g milk protein', 'milk supplement']","['change in IGF-1', 'IGF-1, length, body composition, and Cambridge Neuropsychological Test Automated Battery (CANTAB', 'IGF-1', 'IGF-1 increases', 'Circulating Insulin-Like Growth Factor-1', 'mean correct latency"" from Pattern Recognition Memory and ""pre-extradimensional (pre-ED) shift errors"" from Intra', 'Growth and Cognition', 'blood spot IGF-1', 'height, weight, and fat-free mass']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0017516', 'cui_str': 'Republic of Ghana'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}]","[{'cui': 'C0452575', 'cui_str': 'Porridge (substance)'}, {'cui': 'C4517882', 'cui_str': '8.8 (qualifier value)'}, {'cui': 'C0026138', 'cui_str': 'Milk Proteins'}, {'cui': 'C0026131', 'cui_str': 'Milk'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C4505411', 'cui_str': 'Cambridge Neuropsychological Test Automated Battery'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0524637', 'cui_str': 'Recognition (Psychology)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0333051', 'cui_str': 'Shift (morphologic abnormality)'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0005768'}, {'cui': 'C0848332', 'cui_str': 'Spots on skin (disorder)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass (observable entity)'}]",,0.0402681,"The increase in IGF-1 was 15.3 (95% CI: 3.3, 27.3)","[{'ForeName': 'Benedikte', 'Initials': 'B', 'LastName': 'Grenov', 'Affiliation': 'Department of Nutrition, Exercise, and Sports, University of Copenhagen, Frederiksberg C, Denmark.'}, {'ForeName': 'Anni', 'Initials': 'A', 'LastName': 'Larnkjær', 'Affiliation': 'Department of Nutrition, Exercise, and Sports, University of Copenhagen, Frederiksberg C, Denmark.'}, {'ForeName': 'Reginald', 'Initials': 'R', 'LastName': 'Lee', 'Affiliation': 'Department of Pediatrics, Washington University, St Louis, MO, USA.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Serena', 'Affiliation': 'Global Nutrition, Arla Foods amba, Skejby, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Mølgaard', 'Affiliation': 'Department of Nutrition, Exercise, and Sports, University of Copenhagen, Frederiksberg C, Denmark.'}, {'ForeName': 'Kim F', 'Initials': 'KF', 'LastName': 'Michaelsen', 'Affiliation': 'Department of Nutrition, Exercise, and Sports, University of Copenhagen, Frederiksberg C, Denmark.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Manary', 'Affiliation': 'Department of Pediatrics, Washington University, St Louis, MO, USA.'}]",The Journal of nutrition,['10.1093/jn/nxaa075']
511,31326059,Prevention Program Including Fluoride Varnish and 1450-ppm Fluoride Toothpaste Targeting Young Children in Clinical Setting in UK did not Stop Sental Caries From Developing but Slowed Lesion Progression.,"ARTICLE TITLE AND BIBLIOGRAPHIC INFORMATION


A randomized controlled trial of caries prevention in dental practice. Tickle M, O'Neill C, Donaldson M, Birch S, Noble S, Killough S, Murphy L, Greer M, Brodison J, Verghis R, Worthington HV. J Dent Res 2017; 96:741-46.
SOURCE OF FUNDING


This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme in UK.
TYPE OF STUDY/DESIGN


Randomized clinical trial with a parallel design.",2019,"Tickle M, O'Neill C, Donaldson M, Birch S, Noble S, Killough S, Murphy L, Greer M, Brodison J, Verghis R, Worthington HV.","['caries prevention in dental practice', 'UK']","['Fluoride Varnish and 1450-ppm', 'Fluoride Toothpaste']","[""Tickle M, O'Neill C, Donaldson M, Birch S, Noble S, Killough S, Murphy L, Greer M, Brodison J, Verghis R, Worthington HV""]","[{'cui': 'C0333519', 'cui_str': 'Caries (morphologic abnormality)'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C4522313', 'cui_str': 'Dental (intended site)'}]","[{'cui': 'C0016326', 'cui_str': 'Fluoride Varnishes'}, {'cui': 'C0439187', 'cui_str': 'parts per million'}, {'cui': 'C0016327', 'cui_str': 'Fluorides'}, {'cui': 'C0040462', 'cui_str': 'Toothpaste'}]","[{'cui': 'C0234201', 'cui_str': 'Tickling sensation quality'}, {'cui': 'C0330312', 'cui_str': 'Birch'}]",,0.0712543,"Tickle M, O'Neill C, Donaldson M, Birch S, Noble S, Killough S, Murphy L, Greer M, Brodison J, Verghis R, Worthington HV.","[{'ForeName': 'Laila', 'Initials': 'L', 'LastName': 'Al Dehailan', 'Affiliation': ''}, {'ForeName': 'E Angeles', 'Initials': 'EA', 'LastName': 'Martinez-Mier', 'Affiliation': ''}]",The journal of evidence-based dental practice,['10.1016/j.jebdp.2019.05.013']
512,32210365,Clinical activity of a htert (vx-001) cancer vaccine as post-chemotherapy maintenance immunotherapy in patients with stage IV non-small cell lung cancer: final results of a randomised phase 2 clinical trial.,"BACKGROUND


The cancer vaccine Vx-001, which targets the universal tumour antigen TElomerase Reverse Transcriptase (TERT), can mount specific Vx-001/TERT 572  CD8 + cytotoxic T cells; this immune response is associated with improved overall survival (OS) in patients with advanced/metastatic non-small cell lung cancer (NSCLC).
METHODS


A randomised, double blind, phase 2b trial, in HLA-A*201-positive patients with metastatic, TERT-expressing NSCLC, who did not progress after first-line platinum-based chemotherapy were randomised to receive either Vx-001 or placebo. The primary endpoint of the trial was OS.
RESULTS


Two hundred and twenty-one patients were randomised and 190 (101 and 89 patients in the placebo and the Vx-001 arm, respectively) were analysed for efficacy. There was not treatment-related toxicity >grade 2. The study did not meet its primary endpoint (median OS 11.3 and 14.3 months for the placebo and the Vx-001, respectively; p = 0.86) whereas the median Time to Treatment Failure (TTF) was 3.5 and 3.6 months, respectively. Disease control for >6months was observed in 30 (33.7%) and 26 (25.7%) patients treated with Vx-001 and placebo, respectively. There was no documented objective CR or PR. Long lasting TERT-specific immune response was observed in 29.2% of vaccinated patients who experienced a significantly longer OS compared to non-responders (21.3 and 13.4 months, respectively; p = 0.004).
CONCLUSION


Vx-001 could induce specific CD8 +  immune response but failed to meet its primary endpoint. Subsequent studies have to be focused on the identification and treatment of subgroups of patients able to mount an effective immunological response to Vx-001.
CLINICAL TRIAL REGISTRATION


NCT01935154.",2020,"Long lasting TERT-specific immune response was observed in 29.2% of vaccinated patients who experienced a significantly longer OS compared to non-responders (21.3 and 13.4 months, respectively; p = 0.004).
","['patients with advanced/metastatic non-small cell lung cancer (NSCLC', 'patients with stage IV non-small cell lung cancer', 'Two hundred and twenty-one patients were randomised and 190 (101 and 89 patients in the', 'A*201-positive patients with metastatic, TERT-expressing NSCLC, who did not progress after first-line platinum-based chemotherapy']","['htert (vx-001) cancer vaccine', 'HLA', 'placebo', 'Vx-001 or placebo', 'chemotherapy maintenance immunotherapy']","['objective CR or PR', 'overall survival (OS', 'median Time to Treatment Failure (TTF', 'specific CD8 +  immune response', 'Long lasting TERT-specific immune response']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0278987', 'cui_str': 'Metastatic non-small cell lung cancer (disorder)'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4 (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C4517650', 'cui_str': '220 (qualifier value)'}, {'cui': 'C4517622', 'cui_str': 'One hundred and ninety'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C1958472', 'cui_str': 'Vx001 cpd'}, {'cui': 'C0376659', 'cui_str': 'Vaccines, Tumor'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0021083', 'cui_str': 'Immunotherapy'}]","[{'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3494202', 'cui_str': 'Time-to-Treatment'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0301872', 'cui_str': 'Immune response, function (observable entity)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}]",221.0,0.621622,"Long lasting TERT-specific immune response was observed in 29.2% of vaccinated patients who experienced a significantly longer OS compared to non-responders (21.3 and 13.4 months, respectively; p = 0.004).
","[{'ForeName': 'Cesare', 'Initials': 'C', 'LastName': 'Gridelli', 'Affiliation': 'S.G. Moscati Hospital, Avellino, Italy. cgridelli@libero.it.'}, {'ForeName': 'Tudor', 'Initials': 'T', 'LastName': 'Ciuleanu', 'Affiliation': 'Institutui, Oncologic I. Chircuta, Cluz-Napoca, Romania.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Domine', 'Affiliation': 'Fundacion Jimenez Diaz, Madrid, Spain.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Szczesna', 'Affiliation': 'Mazowieckie Centrum, Otwock, Poland.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Bover', 'Affiliation': 'Son Llatzer Hospital, Palma de Mallorca, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Cobo', 'Affiliation': 'Hospital Regional Universitario Málaga, Instituto de Investigaciones Biomédicas (IBIMA), Málaga, Spain.'}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Kentepozidis', 'Affiliation': '251 General Airforce Hospital, Athens, Greece.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Zarogoulidis', 'Affiliation': 'Papanikolaou General Hospital, Exohi, Greece.'}, {'ForeName': 'Charalabos', 'Initials': 'C', 'LastName': 'Kalofonos', 'Affiliation': 'University Hospital of Patras, Rio, Greece.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Kazarnowisz', 'Affiliation': 'Oddzial Onkologiiz Pododdziatem, Olsztyn, Poland.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Korozan', 'Affiliation': 'Hospicjum Dutkiewicza SAC, Gdansk, Poland.'}, {'ForeName': 'Ramon', 'Initials': 'R', 'LastName': 'de Las Penas', 'Affiliation': 'Hospital Provincial de Castellon, Castellon, Spain.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Majem', 'Affiliation': 'Hospital de la Santa Creui Sant Pau, Barcelona, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Chella', 'Affiliation': 'A.O.U. di Pisa Hospital, Pisa, Italy.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Griesinger', 'Affiliation': 'Pius Hospital, Oldenburg, Germany.'}, {'ForeName': 'Evangelos', 'Initials': 'E', 'LastName': 'Bournakis', 'Affiliation': 'University Hospital ""Aretaieion"", Athens, Greece.'}, {'ForeName': 'Parvis', 'Initials': 'P', 'LastName': 'Sadjadian', 'Affiliation': 'Johannes Wesling Klinikum, Minden, Germany.'}, {'ForeName': 'Athanasios', 'Initials': 'A', 'LastName': 'Kotsakis', 'Affiliation': 'Dpt of Medical Oncology, University General Hospital of Larissa, Larissa, Greece.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Chinet', 'Affiliation': 'Hopital Ambroise Paré, Boulogne-Billancourt, France.'}, {'ForeName': 'Kostantinos N', 'Initials': 'KN', 'LastName': 'Syrigos', 'Affiliation': 'General Hospital of Thoracic Diseases \'\'Sotiria"", Athens, Greece.'}, {'ForeName': 'Pierpaolo', 'Initials': 'P', 'LastName': 'Correale', 'Affiliation': 'University Hospital of Siena, Siena, Italy.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Gallou', 'Affiliation': 'Vaxon-Biotech, Paris, France.'}, {'ForeName': 'Jeanne- Menez', 'Initials': 'JM', 'LastName': 'Jamet', 'Affiliation': 'Vaxon-Biotech, Paris, France.'}, {'ForeName': 'Eleni- Kyriaki', 'Initials': 'EK', 'LastName': 'Vetsika', 'Affiliation': 'University General Hospital of Heraklion, Heraklion, Crete, Greece.'}, {'ForeName': 'Kostas', 'Initials': 'K', 'LastName': 'Kosmatopoulos', 'Affiliation': 'Vaxon-Biotech, Paris, France.'}, {'ForeName': 'Vassilis', 'Initials': 'V', 'LastName': 'Georgoulias', 'Affiliation': 'University General Hospital of Heraklion, Heraklion, Crete, Greece.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",British journal of cancer,['10.1038/s41416-020-0785-y']
513,32211803,"Spices in a High-Saturated-Fat, High-Carbohydrate Meal Reduce Postprandial Proinflammatory Cytokine Secretion in Men with Overweight or Obesity: A 3-Period, Crossover, Randomized Controlled Trial.","BACKGROUND


Postprandial inflammation that occurs concurrently with hyperglycemia and hyperlipidemia after ingestion of a high-saturated-fat, high-carbohydrate meal (HFCM) is a risk factor for cardiovascular disease (CVD). Numerous preclinical and clinical studies demonstrate anti-inflammatory effects of individual spices. However, the effect of consumption of a spice blend on inflammatory mediators has not been examined in a randomized controlled trial.
OBJECTIVES


The objective of this study was to investigate the postprandial effect of a blend of spices in a HFCM on inflammatory cytokine responses.
METHODS


Nonsmoking men (40-65 y old) with overweight/obesity (25 ≤ BMI ≤ 35 kg/m2), elevated waist circumference (≥ 94 cm), and ≥ 1 CVD risk factor were recruited for a 3-period crossover study ( n = 12). In random order, participants consumed the following: a HFCM (∼1000 kcal, 33% kcal from saturated fat and 36% kcal from carbohydrate), a HFCM containing 2 g spice blend, or an HFCM containing 6 g spice blend. The spice blend consisted of basil, bay leaf, black pepper, cinnamon, coriander, cumin, ginger, oregano, parsley, red pepper, rosemary, thyme, and turmeric. Blood was collected before, and hourly for 4 h after the HFCM. Peripheral blood mononuclear cells (PBMCs) were isolated, and the percentage of CD14 +/Human Leukocyte Antigen-DR isotype + (HLA-DR +) monocytes and proinflammatory cytokine concentrations in plasma and LPS-stimulated PBMCs were quantified as secondary outcomes.
RESULTS


There was a significant spice-by-time interaction on IL-1β (P < 0.001), IL-8 (P = 0.020), and TNF-α (P = 0.009) secretion from LPS-stimulated PBMCs. IL-1β secretion from LPS-stimulated PBMCs was significantly reduced (1314%) at 240 min after HFCM consumption containing 6 g, but not 2 g, of spice blend compared with 0 g spice blend.
CONCLUSIONS


A HFCM containing 6 g spice blend attenuated HFCM-induced postprandial IL-1β secretion in men with overweight/obesity.This trial was registered at clinicaltrials.gov as NCT03064958.",2020,There was a significant spice-by-time interaction on IL-1β,"['Men with Overweight or Obesity', 'men with overweight/obesity', 'Nonsmoking men (40-65 y old) with overweight/obesity (25 ≤ BMI ≤ 35\xa0kg/m2), elevated waist circumference (≥ 94\xa0cm), and ≥ 1 CVD risk factor were recruited for a 3-period crossover study ( n\xa0=\xa012']","['HFCM', 'carbohydrate meal (HFCM', 'High-Saturated-Fat, High-Carbohydrate Meal', 'HFCM containing 2\xa0g spice blend, or an HFCM containing 6\xa0g spice blend', 'basil, bay leaf, black pepper, cinnamon, coriander, cumin, ginger, oregano, parsley, red pepper, rosemary, thyme, and turmeric', 'HFCM (∼1000\xa0kcal, 33%\xa0kcal from saturated fat and 36%\xa0kcal from carbohydrate']","['IL-8', 'TNF-α', 'IL-1β secretion from LPS-stimulated PBMCs', 'Postprandial Proinflammatory Cytokine Secretion', 'percentage of CD14 +/Human', 'Peripheral blood mononuclear cells (PBMCs', 'IL-1β', 'postprandial IL-1β secretion', 'Leukocyte Antigen-DR isotype + (HLA-DR +) monocytes and proinflammatory cytokine concentrations']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}]","[{'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0597423', 'cui_str': 'Fatty Acids, Saturated'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0037910', 'cui_str': 'Spices'}, {'cui': 'C1722869', 'cui_str': '(glycyl-prolyl-glycyl-glycyl-alanyl)6-glycine'}, {'cui': 'C0600402', 'cui_str': 'Basil'}, {'cui': 'C0453244', 'cui_str': 'Bay Leaf'}, {'cui': 'C0162750', 'cui_str': 'Black Pepper'}, {'cui': 'C1112857', 'cui_str': 'Cinnamon'}, {'cui': 'C0162747', 'cui_str': 'Coriander'}, {'cui': 'C0524875', 'cui_str': 'Cumin'}, {'cui': 'C1879327', 'cui_str': 'Zingiber officinale'}, {'cui': 'C0453263', 'cui_str': 'Oregano'}, {'cui': 'C0994493', 'cui_str': 'Parsley'}, {'cui': 'C0446306', 'cui_str': 'Bell Pepper'}, {'cui': 'C1262899', 'cui_str': 'Rosemary (substance)'}, {'cui': 'C1305848', 'cui_str': 'Thyme'}, {'cui': 'C0041356', 'cui_str': 'Tumeric'}, {'cui': 'C0439259', 'cui_str': 'kilocalorie'}]","[{'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0036537', 'cui_str': 'Secretions'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C0019721', 'cui_str': 'HL-A Antigens'}, {'cui': 'C0019764', 'cui_str': 'HLA-DR'}, {'cui': 'C0026473', 'cui_str': 'Monocytes'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",,0.0907223,There was a significant spice-by-time interaction on IL-1β,"[{'ForeName': 'Ester S', 'Initials': 'ES', 'LastName': 'Oh', 'Affiliation': 'Department of Nutritional Sciences, The Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Kristina S', 'Initials': 'KS', 'LastName': 'Petersen', 'Affiliation': 'Department of Nutritional Sciences, The Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Penny M', 'Initials': 'PM', 'LastName': 'Kris-Etherton', 'Affiliation': 'Department of Nutritional Sciences, The Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Connie J', 'Initials': 'CJ', 'LastName': 'Rogers', 'Affiliation': 'Department of Nutritional Sciences, The Pennsylvania State University, University Park, PA, USA.'}]",The Journal of nutrition,['10.1093/jn/nxaa063']
514,31657625,Improved Glycemic Control Through the Use of a Telehomecare Program in Patients with Diabetes Treated with Insulin.,"Background:  With the drastic surge in the prevalence of diabetes, the use of medical resources for management of diabetic patients increased markedly. This study aimed to evaluate the impact of telehomecare (THC) use on clinical efficacy, nursing interventions, and medical visits compared with the standard care in insulin-treated diabetic patients.  Materials and Methods:  A prospective noninferiority clinical trial was designed. Participants were assigned to either an intervention group provided with a THC system during 3 months or to a control group. Main outcome was the difference in A1c at 3 months compared with baseline. Secondary outcomes were the difference in A1c at 6 months compared with baseline, the number of medical visits during the 6-month period of the study, and nursing interventions during the 3 months on THC.  Results:  A total of 92 participants completed the study. A significant decrease in A1c levels was observed in the THC group ( n  = 45) compared with the control group ( n  = 47) at 3 months (-0.61% vs. -0.06%, respectively,  P  = 0.048) and at 6 months (-0.37% vs. -0.10%, respectively,  P  = 0.036). The THC group had an average of 0.6 medical visit compared with 1.0 in the control group ( P  < 0.001). An increase in nursing interventions (mainly e-mails) was noted in THC group ( n  = 14.7) compared with control group ( n  = 1.1).  Conclusions:  This THC program demonstrates improvement in glycemic control and a decrease in the number of medical visits. However, it is important to consider an additional burden in nursing interventions when implementing a THC program.",2020,"A significant decrease in A1c levels was observed in the THC group (n=45) compared to the control group (n= 47) at 3 months (-0.61% vs -0.06%, respectively, p = 0.048) and at 6 months (-0.37% vs -0.10%, respectively, p = 0.036).","['Diabetic Patients Treated with Insulin', 'insulin-treated diabetic patients', '92 participants completed the study']","['intervention group provided with a THC system', 'THC', 'telehomecare (THC']","['glycemic control', 'number of medical visits', 'A1c levels', 'nursing interventions']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0028678', 'cui_str': 'nursing care'}]",92.0,0.0573843,"A significant decrease in A1c levels was observed in the THC group (n=45) compared to the control group (n= 47) at 3 months (-0.61% vs -0.06%, respectively, p = 0.048) and at 6 months (-0.37% vs -0.10%, respectively, p = 0.036).","[{'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Lemelin', 'Affiliation': ""Endocrinology Division, Medicine Department, Centre de Recherche du Centre Hospitalier de l'Université de Montréal (CRCHUM), Montreal, Quebec, Canada.""}, {'ForeName': 'Ariane', 'Initials': 'A', 'LastName': 'Godbout', 'Affiliation': ""Endocrinology Division, Medicine Department, Centre de Recherche du Centre Hospitalier de l'Université de Montréal (CRCHUM), Montreal, Quebec, Canada.""}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Paré', 'Affiliation': 'Research Chair in Digital Health, HEC Montreal, Montreal, Canada.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Bernard', 'Affiliation': ""Endocrinology Division, Medicine Department, Centre de Recherche du Centre Hospitalier de l'Université de Montréal (CRCHUM), Montreal, Quebec, Canada.""}]",Diabetes technology & therapeutics,['10.1089/dia.2019.0324']
515,30386978,Communicating Actively Responding Empathically (CARE): Comparison of Communication Training Workshops for Health Professionals Working in Cancer Care.,"Accessing full-day communication skills training can be challenging for health professionals working in cancer care. This study aimed to examine the effectiveness of Communicating Actively, Responding Empathically (CARE Express), a modified 2-h communication skills training course, across measures of health professional confidence, skills and attitudes. Cancer care health professionals (n = 147) were recruited from allied health, nursing and medical disciplines, using a partial randomisation to allocate to three arms: control, two-hour training (CARE Express) and 1-day training (CARE). Perceived confidence and skills were measured by self-report using a purpose-built scale, and written responses to a challenging clinical encounter were obtained at baseline, post-training and three-months post-training. Attitudes toward psychosocial issues were evaluated with the Physician Belief Scale at baseline and 3 months post-training. No changes were observed in the control group (n = 50) from baseline to 3 months follow-up. Participants in the CARE Express (n = 48) and CARE (n = 49) groups had significant improvement in confidence in identifying/responding to emotions between baseline and 3 months post-training (p < 0.001), as well as their attitude toward psychosocial care (p < 0.001). A significant increase in ""acknowledging"" responses from baseline to 3 months was also observed for CARE Express and CARE (p < 0.001), with no difference between groups. CARE Express and CARE resulted in changes in confidence in emotional identification/response, psychosocial focus and communication skills maintained at 3 months post-training. Whilst the 1-day workshop has been regarded as gold standard, this study has revealed positive outcomes with a modified 2-h version, thus offering a potential alternate training model.",2020,"CARE Express and CARE resulted in changes in confidence in emotional identification/response, psychosocial focus and communication skills maintained at 3 months post-training.","['Participants in the CARE Express (n\u2009=\u200948) and CARE (n\u2009', 'Cancer care health professionals (n\u2009=\u2009147) were recruited from allied health, nursing and medical disciplines, using a partial randomisation to allocate to three arms', 'Health Professionals Working in Cancer Care']","['Communication Training Workshops', 'control, two-hour training (CARE Express) and 1-day training (CARE']","['acknowledging"" responses', 'attitude toward psychosocial care', 'Perceived confidence and skills', 'health professional confidence, skills and attitudes', 'Physician Belief Scale', 'confidence in identifying/responding to emotions', 'confidence in emotional identification/response, psychosocial focus and communication skills']","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0028678', 'cui_str': 'nursing care'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0043227', 'cui_str': 'Work'}]","[{'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C2958078', 'cui_str': 'Psychosocial care'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0222045'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0020792', 'cui_str': 'Identification'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0870313', 'cui_str': 'Communication skills'}]",147.0,0.0210218,"CARE Express and CARE resulted in changes in confidence in emotional identification/response, psychosocial focus and communication skills maintained at 3 months post-training.","[{'ForeName': 'Jodie', 'Initials': 'J', 'LastName': 'Nixon', 'Affiliation': 'Occupational Therapy Department, Princess Alexandra Hospital, Ipswich Road, Woolloongabba, Brisbane, 4102, Australia. jodie.nixon@health.qld.gov.au.'}, {'ForeName': 'Lyndal', 'Initials': 'L', 'LastName': 'Gray', 'Affiliation': 'Occupational Therapy Department, Princess Alexandra Hospital, Ipswich Road, Woolloongabba, Brisbane, 4102, Australia.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Turner', 'Affiliation': 'Faculty of Medicine, The University of Queensland, St Lucia, QLD, 4027, Australia.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Bernard', 'Affiliation': 'QFAB Bioinformatics, Institute for Molecular Bioscience, The University of Queensland, St Lucia, QLD, 4027, Australia.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Scaife', 'Affiliation': 'Cancer Services, Princess Alexandra Hospital, Ipswich Road, Woolloongabba, Brisbane, 4102, Australia.'}, {'ForeName': 'Bena', 'Initials': 'B', 'LastName': 'Cartmill', 'Affiliation': 'School of Health and Rehabilitation Sciences, The University of Queensland, St Lucia, Australia.'}]",Journal of cancer education : the official journal of the American Association for Cancer Education,['10.1007/s13187-018-1439-0']
516,31638433,The Effect of Acarbose on Glycemic Variability in Patients with Type 2 Diabetes Mellitus Using Premixed Insulin Compared to Metformin (AIM): An Open-Label Randomized Trial.,"Background:  Acarbose (ACA) can effectively reduce the postprandial blood glucose and has similar antidiabetic effects as metformin (MET). To our knowledge, few studies have compared the effect of ACA or MET on glucose fluctuations. In the present study, we explored the effect of ACA or MET combined with premixed insulin (INS) on glycemic control and glycemic variability (GV).  Methods:  This was an open-label randomized trial that was conducted in type 2 diabetic patients taking premixed insulin. The patients were assigned to 12 weeks of MET ( n  = 62) or ACA ( n  = 62) treatment combined with INS. The main outcomes were changes in GV and glycosylated hemoglobin A1c (HbA1c) compared with baseline.  Results:  Compared with baseline, several GV indices (standard deviation [SD], mean amplitude of glycemic excursions [MAGE]) and blood glucose control indices (mean glucose [MG], time in range [TIR] and HbA1c) were both significantly improved in INS+ACA and INS+MET after 12-week therapy. However, coefficient of variation (CV) was significantly reduced in INS+ACA but not in INS+MET. Moreover, compared with INS+MET, INS+ACA led to a more pronounced percentage change from baseline in CV (26.3% [1.7%-44.6%] vs. 11.9% [-7.0% to 29.9%],  P  = 0.022), MAGE (40.5% [20.1%-60.5%] vs. 25.2% [-2.1% to 43.4%],  P  = 0.007) and SD (38.6% [25.2%-57.9%] vs. 30.1% [10.8%-46.5%],  P  = 0.041).  Conclusion:  Both MET and ACE combined with INS effectively reduced blood glucose. Compared with MET, ACA combined with INS reduced GV.",2020,"However, coefficient of variation (CV) was significantly reduced in INS+ACA but not in INS+MET.","['patients with type 2 diabetes mellitus using', 'type 2 diabetic patients taking']","['INS+ACA', 'INS+MET, INS+ACA', 'Metformin', 'Acarbose', 'premixed Insulin', 'ACA or MET combined with premixed insulin (INS', ' Acarbose (ACA', 'premixed insulin', 'ACA (n=62) treatment combined with INS']","['glycemic variability', 'changes in GV and hemoglobin A1c (HbA1c', 'glycemic control and glycemic variability (GV', 'blood glucose', 'MAGE', 'several GV indices [standard deviation (SD), mean amplitude of glycemic excursions (MAGE)] and blood glucose control indices [mean glucose (MG), time in range (TIR) and HbA1c', 'coefficient of variation (CV', 'postprandial blood glucose']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C1515187', 'cui_str': 'Take'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0050393', 'cui_str': 'Acarbose'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}]",,0.185502,"However, coefficient of variation (CV) was significantly reduced in INS+ACA but not in INS+MET.","[{'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Gao', 'Affiliation': ""Department of Endocrinology and Metabolism, Shanghai Clinical Center for Diabetes, Shanghai Diabetes Institute, Shanghai Key Laboratory of Diabetes Mellitus, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, China.""}, {'ForeName': 'Xiaojing', 'Initials': 'X', 'LastName': 'Ma', 'Affiliation': ""Department of Endocrinology and Metabolism, Shanghai Clinical Center for Diabetes, Shanghai Diabetes Institute, Shanghai Key Laboratory of Diabetes Mellitus, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, China.""}, {'ForeName': 'Jiahui', 'Initials': 'J', 'LastName': 'Peng', 'Affiliation': ""Department of Endocrinology and Metabolism, Shanghai Clinical Center for Diabetes, Shanghai Diabetes Institute, Shanghai Key Laboratory of Diabetes Mellitus, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, China.""}, {'ForeName': 'Jingyi', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': ""Department of Endocrinology and Metabolism, Shanghai Clinical Center for Diabetes, Shanghai Diabetes Institute, Shanghai Key Laboratory of Diabetes Mellitus, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Lu', 'Affiliation': ""Department of Endocrinology and Metabolism, Shanghai Clinical Center for Diabetes, Shanghai Diabetes Institute, Shanghai Key Laboratory of Diabetes Mellitus, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhu', 'Affiliation': ""Department of Endocrinology and Metabolism, Shanghai Clinical Center for Diabetes, Shanghai Diabetes Institute, Shanghai Key Laboratory of Diabetes Mellitus, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, China.""}, {'ForeName': 'Yuqian', 'Initials': 'Y', 'LastName': 'Bao', 'Affiliation': ""Department of Endocrinology and Metabolism, Shanghai Clinical Center for Diabetes, Shanghai Diabetes Institute, Shanghai Key Laboratory of Diabetes Mellitus, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, China.""}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Vigersky', 'Affiliation': 'Diabetes Institute of the Walter Reed National Military Medical Center, Bethesda, Maryland.'}, {'ForeName': 'Weiping', 'Initials': 'W', 'LastName': 'Jia', 'Affiliation': ""Department of Endocrinology and Metabolism, Shanghai Clinical Center for Diabetes, Shanghai Diabetes Institute, Shanghai Key Laboratory of Diabetes Mellitus, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, China.""}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': ""Department of Endocrinology and Metabolism, Shanghai Clinical Center for Diabetes, Shanghai Diabetes Institute, Shanghai Key Laboratory of Diabetes Mellitus, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, China.""}]",Diabetes technology & therapeutics,['10.1089/dia.2019.0290']
517,31759333,Single and repeated ketamine infusions for reduction of suicidal ideation in treatment-resistant depression.,"Repeated administration of subanesthetic intravenous ketamine may prolong the rapid decrease in suicidal ideation (SI) elicited by single infusions. The purpose of this secondary analysis was to evaluate reduction in SI with a single ketamine infusion compared with an active control, and prolonged suppression of SI with repeated and maintenance infusions. Thirty-seven participants with treatment-resistant depression (TRD) and baseline SI first received a single ketamine infusion during a randomized, double-blind crossover with midazolam. Following relapse of depressive symptoms, participants received six open-label ketamine infusions administered thrice-weekly over 2 weeks. Antidepressant responders (≥50% decrease in Montgomery-Åsberg Depression Rating Scale [MADRS] scores) received four further open-label infusions administered once-weekly. Changes in SI were assessed with the suicide items on the MADRS (item 10, MADRS-SI) and the Quick Inventory of Depressive Symptomatology-Self Report (item 12, QIDS-SI). Linear mixed models revealed that compared with midazolam, a single ketamine infusion elicited larger reduction in SI (P = 0.01), with maximal effects measured at 7 days postinfusion (P < 0.001, Cohen's d = 0.83). Participants had cumulative reductions in MADRS-SI scores with repeated infusions (P < 0.001), and no further change with maintenance infusions (P = 0.94). QIDS-SI results were consistent with MADRS-SI. Overall, 69% of participants had a complete alleviation of SI following repeated infusions. In TRD, single and repeated ketamine infusions resulted in decreases in SI which were maintained with once-weekly maintenance infusions. This study adds to the growing body of research suggesting ketamine as a possible novel treatment strategy for SI in mood disorders.",2020,"Participants had cumulative reductions in MADRS-SI scores with repeated infusions (P < 0.001), and no further change with maintenance infusions (P = 0.94).",['Thirty-seven participants with treatment-resistant depression (TRD) and baseline SI first received a single'],"['midazolam', 'six open-label ketamine', 'ketamine', 'subanesthetic intravenous ketamine', 'ketamine infusion', 'ketamine infusions']","['Changes in SI', 'Quick Inventory of Depressive Symptomatology-Self Report', 'cumulative reductions in MADRS-SI scores', 'suicidal ideation (SI', 'SI', 'suicidal ideation', 'Montgomery-Åsberg Depression Rating Scale [MADRS] scores', 'complete alleviation of SI']","[{'cui': 'C4319569', 'cui_str': '37 (qualifier value)'}, {'cui': 'C2063866', 'cui_str': 'Refractory Depression'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}]","[{'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C4720917', 'cui_str': 'Quick inventory of depressive symptomatology (assessment scale)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0424000', 'cui_str': 'Suicidal Ideation'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]",37.0,0.234581,"Participants had cumulative reductions in MADRS-SI scores with repeated infusions (P < 0.001), and no further change with maintenance infusions (P = 0.94).","[{'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Phillips', 'Affiliation': ""Mood Disorders Research Unit, The Royal's Institute of Mental Health Research, Ottawa, ON, Canada. Jennifer.Phillips@theroyal.ca.""}, {'ForeName': 'Sandhaya', 'Initials': 'S', 'LastName': 'Norris', 'Affiliation': ""Mood Disorders Research Unit, The Royal's Institute of Mental Health Research, Ottawa, ON, Canada.""}, {'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'Talbot', 'Affiliation': ""Mood Disorders Research Unit, The Royal's Institute of Mental Health Research, Ottawa, ON, Canada.""}, {'ForeName': 'Taylor', 'Initials': 'T', 'LastName': 'Hatchard', 'Affiliation': ""Mood Disorders Research Unit, The Royal's Institute of Mental Health Research, Ottawa, ON, Canada.""}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Ortiz', 'Affiliation': ""Mood Disorders Research Unit, The Royal's Institute of Mental Health Research, Ottawa, ON, Canada.""}, {'ForeName': 'Meagan', 'Initials': 'M', 'LastName': 'Birmingham', 'Affiliation': ""Mood Disorders Research Unit, The Royal's Institute of Mental Health Research, Ottawa, ON, Canada.""}, {'ForeName': 'Olabisi', 'Initials': 'O', 'LastName': 'Owoeye', 'Affiliation': ""Mood Disorders Research Unit, The Royal's Institute of Mental Health Research, Ottawa, ON, Canada.""}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Batten', 'Affiliation': ""Mood Disorders Research Unit, The Royal's Institute of Mental Health Research, Ottawa, ON, Canada.""}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Blier', 'Affiliation': ""Mood Disorders Research Unit, The Royal's Institute of Mental Health Research, Ottawa, ON, Canada.""}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0570-x']
518,31662373,Evaluating the efficacy of Internet-Based Exercise programme Aimed at Treating knee Osteoarthritis (iBEAT-OA) in the community: a study protocol for a randomised controlled trial.,"INTRODUCTION


Knee osteoarthritis (OA) is the most common joint disease worldwide. As of today, there are no disease-modifying drugs, but there is evidence that muscle strengthening exercises can substantially reduce pain and improve function in this disorder, and one very well tested physiotherapy protocol is the 'Better Management of Patients with Osteoarthritis' developed in Sweden. Given the high prevalence of knee OA, a potentially cost-effective, digitally delivered approach to treat knee OA should be trialled. This study aims to explore the benefits of iBEAT-OA (Internet-Based Exercise programme Aimed at Treating knee Osteoarthritis) in modulating pain, function and other health-related outcomes in individuals with knee OA.
METHODS AND ANALYSIS


A randomised controlled trial was designed to evaluate the efficacy of a web-based exercise programme in a population with knee OA compared with standard community care provided by general practitioners (GPs) in the UK. We anticipate recruiting participants into equal groups. The intervention group (n=67) will exercise for 20-30 min daily for six consecutive weeks, whereas the control group (n=67) will follow GP-recommended routine care. The participants will be assessed using a Numerical Rating Scale, the Western Ontario and McMaster Universities Osteoarthritis Index, the Arthritis Research UK Musculoskeletal Health Questionnaire, the Pittsburgh Sleep Quality Index, 30 s sit to stand test, timed up and go test, quantitative sensory testing, musculoskeletal ultrasound scan, muscle thickness assessment of the vastus lateralis, and quadriceps muscles force generation during an isokinetic maximum voluntary contraction (MVC). Samples of urine, blood, faeces and synovial fluid will be collected to establish biomarkers associated with changes in pain and sleep patterns in individuals affected with knee OA. Standard parametric regression methods will be used for statistical analysis.
ETHICS AND DISSEMINATION


Ethical approval was obtained from the Research Ethics Committee (ref: 18/EM/0154) and the Health Research Authority (protocol no: 18021). The study was registered in June 2018. The results of the trial will be submitted for publication in a peer-reviewed journal.
TRIAL REGISTRATION NUMBER


NCT03545048.",2019,A randomised controlled trial was designed to evaluate the efficacy of a web-based exercise programme in a population with knee OA compared with standard community care provided by general practitioners (GPs) in the UK.,"['population with knee OA compared with standard community care provided by general practitioners (GPs) in the UK', 'individuals with knee OA', ""Patients with Osteoarthritis' developed in Sweden""]","['web-based exercise programme', 'iBEAT-OA (Internet-Based Exercise programme', 'control group (n=67) will follow GP-recommended routine care', 'Internet-Based Exercise programme']","['pain and sleep patterns', 'Numerical Rating Scale, the Western Ontario and McMaster Universities Osteoarthritis Index, the Arthritis Research UK Musculoskeletal Health Questionnaire, the Pittsburgh Sleep Quality Index']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0017319', 'cui_str': 'Physicians, General Practice'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}]","[{'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0474396', 'cui_str': 'Sleep pattern finding'}, {'cui': 'C0222045'}, {'cui': 'C3472647', 'cui_str': 'WOMAC index'}, {'cui': 'C3666006', 'cui_str': 'Arthritis (SMQ)'}, {'cui': 'C0035168'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3697468', 'cui_str': 'PSQI - Pittsburgh sleep quality index'}]",,0.131594,A randomised controlled trial was designed to evaluate the efficacy of a web-based exercise programme in a population with knee OA compared with standard community care provided by general practitioners (GPs) in the UK.,"[{'ForeName': 'Sameer Akram', 'Initials': 'SA', 'LastName': 'Gohir', 'Affiliation': 'NIHR Nottingham Biomedical Research Centre, School of Medicine, University of Nottingham, Nottingham, East Midland, UK sameer.gohir@nottingham.ac.uk.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Greenhaff', 'Affiliation': 'NIHR Nottingham Biomedical Research Centre, School of Medicine, University of Nottingham, Nottingham, East Midland, UK.'}, {'ForeName': 'Abhishek', 'Initials': 'A', 'LastName': 'Abhishek', 'Affiliation': 'NIHR Nottingham Biomedical Research Centre, School of Medicine, University of Nottingham, Nottingham, East Midland, UK.'}, {'ForeName': 'Ana M', 'Initials': 'AM', 'LastName': 'Valdes', 'Affiliation': 'NIHR Nottingham Biomedical Research Centre, School of Medicine, University of Nottingham, Nottingham, East Midland, UK.'}]",BMJ open,['10.1136/bmjopen-2019-030564']
519,31662385,"Hybrid cardiac rehabilitation trial (HYCARET): protocol of a randomised, multicentre, non-inferiority trial in South America.","INTRODUCTION


Cardiac rehabilitation (CR) programmes are well established, and their effectiveness and cost-effectiveness are proven. In spite of this, CR remains underused, especially in lower-resource settings such as Latin America. There is an urgent need to create more accessible CR delivery models to reach all patients in need. This trial aims to evaluate if the prevention of recurrent cardiovascular events is not inferior in a hybrid CR programme compared with a standard programme.
METHOD AND ANALYSIS


A non-inferiority, pragmatic, multicentre, parallel (1:1), prospective, randomised and open with blinded endpoint assessment clinical trial will be conducted. 308 patients with coronary artery disease will be recruited consecutively. Participants will be randomised to hybrid or standard rehabilitation programme. The hybrid CR programme includes 10 supervised exercise sessions and individualised lifestyle counselling by a physiotherapist, with a transition after 4-6 weeks to unsupervised delivery via text messages and phone calls. The standard CR consists of 18-22 supervised exercise sessions, as well as group education sessions about lifestyle. Intervention in both groups is between 8 and 12 weeks. The primary outcome is a composite of cardiovascular mortality and hospitalisations due to cardiovascular causes. Secondary outcomes are health-related quality of life, exercise capacity, muscle strength, heart-healthy behaviour, return-to-work, cardiovascular risk factor, adherence, and exercise-related adverse events. The outcomes will be measured at the end of intervention, at 6 months and at 12 months follow-up from recruitment. The primary outcome will be tracked through the end of the trial. Per-protocol and intention-to-treat analysis will be undertaken.Cox regression model will be used to compare primary outcome among study groups.
ETHICS AND DISSEMINATION


Ethics committees at the sponsor institution and each centre where participants will be recruited approved the study protocol and the Informed Consent. Research findings will be published in peer-reviewed journals; additionally, results will be disseminated among region stakeholders.
TRIAL REGISTRATION NUMBER


NCT03881150; Pre-results.
DATE AND VERSION


01 October 2019.",2019,"This trial aims to evaluate if the prevention of recurrent cardiovascular events is not inferior in a hybrid CR programme compared with a standard programme.
","['South America', '308 patients with coronary artery disease will be recruited consecutively']","['hybrid or standard rehabilitation programme', 'Cardiac rehabilitation (CR) programmes', 'hybrid CR programme']","['composite of cardiovascular mortality and hospitalisations due to cardiovascular causes', 'health-related quality of life, exercise capacity, muscle strength, heart-healthy behaviour, return-to-work, cardiovascular risk factor, adherence, and exercise-related adverse events']","[{'cui': 'C0037713', 'cui_str': 'South America'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}]","[{'cui': 'C0020205', 'cui_str': 'Hybrids'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0700431', 'cui_str': 'Cardiovascular Rehabilitation'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0425105', 'cui_str': 'Back to Work'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",308.0,0.20877,"This trial aims to evaluate if the prevention of recurrent cardiovascular events is not inferior in a hybrid CR programme compared with a standard programme.
","[{'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Serón', 'Affiliation': 'Internal Medicine Department - CIGES, Universidad de La Frontera, Temuco, Chile pamela.seron@ufrontera.cl.'}, {'ForeName': 'Maria J', 'Initials': 'MJ', 'LastName': 'Oliveros', 'Affiliation': 'Internal Medicine Department - CIGES, Universidad de La Frontera, Temuco, Chile.'}, {'ForeName': 'Gabriel N', 'Initials': 'GN', 'LastName': 'Marzuca-Nassr', 'Affiliation': 'Internal Medicine Department, Universidad de La Frontera, Temuco, Chile.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Lanas', 'Affiliation': 'Internal Medicine Department - CIGES, Universidad de La Frontera, Temuco, Chile.'}, {'ForeName': 'Gladys', 'Initials': 'G', 'LastName': 'Morales', 'Affiliation': 'Public Health Department - EPICYN, Universidad de La Frontera, Temuco, Chile.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Román', 'Affiliation': 'Faculty of Medicine, Pontificia Universidad Catolica de Chile, Santiago, Chile.'}, {'ForeName': 'Sergio R', 'Initials': 'SR', 'LastName': 'Muñoz', 'Affiliation': 'Public Heath Department - CIGES, Universidad de La Frontera, Temuco, Chile.'}, {'ForeName': 'Nicolás', 'Initials': 'N', 'LastName': 'Saavedra', 'Affiliation': 'Basic Sciences Department, Universidad de La Frontera, Temuco, Chile.'}, {'ForeName': 'Sherry L', 'Initials': 'SL', 'LastName': 'Grace', 'Affiliation': 'Faculty of Health, York University, Toronto, Ontario, Canada.'}]",BMJ open,['10.1136/bmjopen-2019-031213']
520,31791039,Mechanistic link between right prefrontal cortical activity and anxious arousal revealed using transcranial magnetic stimulation in healthy subjects.,"Much of the mechanistic research on anxiety focuses on subcortical structures such as the amygdala; however, less is known about the distributed cortical circuit that also contributes to anxiety expression. One way to learn about this circuit is to probe candidate regions using transcranial magnetic stimulation (TMS). In this study, we tested the involvement of the dorsolateral prefrontal cortex (dlPFC), in anxiety expression using 10 Hz repetitive TMS (rTMS). In a within-subject, crossover experiment, the study measured anxiety in healthy subjects before and after a session of 10 Hz rTMS to the right dorsolateral prefrontal cortex (dlPFC). It used threat of predictable and unpredictable shock to induce anxiety and anxiety potentiated startle to assess anxiety. Counter to our hypotheses, results showed an increase in anxiety-potentiated startle following active but not sham rTMS. These results suggest a mechanistic link between right dlPFC activity and physiological anxiety expression. This result supports current models of prefrontal asymmetry in affect, and lays the groundwork for further exploration into the cortical mechanisms mediating anxiety, which may lead to novel anxiety treatments.",2020,"Counter to our hypotheses, results showed an increase in anxiety-potentiated startle following active but not sham rTMS.","['healthy subjects before and after a session of 10\u2009Hz rTMS to the right dorsolateral prefrontal cortex (dlPFC', 'healthy subjects']","['10\u2009Hz repetitive TMS (rTMS', 'transcranial magnetic stimulation', 'transcranial magnetic stimulation (TMS']",['anxiety-potentiated startle'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0546911', 'cui_str': 'To the right (qualifier value)'}, {'cui': 'C4019080', 'cui_str': 'Dorsolateral Prefrontal Cortex'}]","[{'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation (procedure)'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.0106782,"Counter to our hypotheses, results showed an increase in anxiety-potentiated startle following active but not sham rTMS.","[{'ForeName': 'Nicholas L', 'Initials': 'NL', 'LastName': 'Balderston', 'Affiliation': 'Section on Neurobiology of Fear and Anxiety, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA. nicholas.balderston@pennmedicine.upenn.edu.'}, {'ForeName': 'Emily M', 'Initials': 'EM', 'LastName': 'Beydler', 'Affiliation': 'Section on Neurobiology of Fear and Anxiety, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Roberts', 'Affiliation': 'Section on Neurobiology of Fear and Anxiety, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Zhi-De', 'Initials': 'ZD', 'LastName': 'Deng', 'Affiliation': 'Noninvasive Neuromodulation Unit, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Radman', 'Affiliation': 'Noninvasive Neuromodulation Unit, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Tiffany', 'Initials': 'T', 'LastName': 'Lago', 'Affiliation': 'Section on Neurobiology of Fear and Anxiety, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Luber', 'Affiliation': 'Noninvasive Neuromodulation Unit, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Sarah H', 'Initials': 'SH', 'LastName': 'Lisanby', 'Affiliation': 'Noninvasive Neuromodulation Unit, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'Ernst', 'Affiliation': 'Section on Neurobiology of Fear and Anxiety, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Grillon', 'Affiliation': 'Section on Neurobiology of Fear and Anxiety, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0583-5']
521,31662352,Referrals for uncomplicated lower back pain: a cluster parallel randomised trial of patient-centred communication to improve the management of acute back pain in primary care. A study protocol.,"INTRODUCTION


Low back pain (LBP) is one of the most frequent encounters in General Practice. Investigation and referral remain common despite the self-limiting character of episodes that are not largely attributable to specific underlying injuries. Identifying patients' ideas, concerns and expectations (ICE) is a well-established element within consultation skills training and has been shown to improve prescribing. It can be a powerful communication tool setting the base for transferring and adjusting adequate clinical information. This study aims to evaluate whether ICE can decrease unnecessary medicine in the management of acute LBP in primary care. METHODS AND ANALYSIS:  Research question : Does ICE training intervention have an effect on doctors' referrals of patients suffering from acute LBP?  Population : Recruitment to this parallel cluster randomised trial will take place among general practitioners belonging to four independent practice networks in Northern Bavaria/Germany.  Intervention : At baseline, 24 out of 48 doctors will be randomly assigned to take part in a 1-day training session covering theoretical background and clinical implementation of patient-centred communication by stimulating ICE. They will also be given access to a web-based supporting tool for reflective practice on their communication skills.  Comparison : GPs in the control group will continue consultations as usual.  Outcome : Outcome measures are referrals to diagnostic imaging, physiotherapy and specialists obtained from routine practice data, compared between intervention and control group.  Time : Referrals of patients consulting their doctors for documented LBP will be monitored up to 3 months after the ICE training intervention.
ETHICS AND DISSEMINATION


Ethical approval for the study was obtained by the Ethics Committee of the University Erlangen-Nuremberg (296_17B). Results will be disseminated by conference presentations and journal publications.
TRIAL REGISTRATION NUMBER


The trial is registered in clinicaltrials.gov (NCT03711071).",2019,Does ICE training intervention have an effect on doctors' referrals of patients suffering from acute LBP?  ,"['general practitioners belonging to four independent practice networks in Northern Bavaria/Germany', 'acute LBP in primary care', 'acute back pain in primary care', 'uncomplicated lower back pain', 'patients suffering from acute LBP', '24 out of 48 doctors']","['Intervention ', 'ICE', 'ICE training intervention']","['Time ', 'referrals to diagnostic imaging, physiotherapy and specialists obtained from routine practice data']","[{'cui': 'C0017319', 'cui_str': 'Physicians, General Practice'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0699896', 'cui_str': 'Acute back pain'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}]","[{'cui': 'C0349714', 'cui_str': 'Icing (substance)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C4255083', 'cui_str': 'diagnostic imaging'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}]",48.0,0.185709,Does ICE training intervention have an effect on doctors' referrals of patients suffering from acute LBP?  ,"[{'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Schedlbauer', 'Affiliation': 'Insitute of General Practice, Friedrich-Alexander-Universität Erlangen Nürnberg (FAU), Universitätsstraße 29, Erlangen, Germany angela.schedlbauer@uk-erlangen.de.'}, {'ForeName': 'Larissa', 'Initials': 'L', 'LastName': 'Burggraf', 'Affiliation': 'Insitute of General Practice, Friedrich-Alexander-Universität Erlangen Nürnberg (FAU), Universitätsstraße 29, Erlangen, Germany.'}, {'ForeName': 'Susann', 'Initials': 'S', 'LastName': 'Hueber', 'Affiliation': 'Insitute of General Practice, Friedrich-Alexander-Universität Erlangen Nürnberg (FAU), Universitätsstraße 29, Erlangen, Germany.'}, {'ForeName': 'Irini-Alexia', 'Initials': 'IA', 'LastName': 'Terzakis-Snyder', 'Affiliation': 'Institute of Clinical Psychology, Friedrich-Alexander-Universität Erlangen Nürnberg (FAU), Nägelsbachstrasse 25a, Erlangen, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kühlein', 'Affiliation': 'Insitute of General Practice, Friedrich-Alexander-Universität Erlangen Nürnberg (FAU), Universitätsstraße 29, Erlangen, Germany.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Roos', 'Affiliation': 'Insitute of General Practice, Friedrich-Alexander-Universität Erlangen Nürnberg (FAU), Universitätsstraße 29, Erlangen, Germany.'}]",BMJ open,['10.1136/bmjopen-2018-027718']
522,31662370,Effects of photobiomodulation therapy combined to static magnetic field in strength training and detraining in humans: protocol for a randomised placebo-controlled trial.,"INTRODUCTION


In recent years, it has been demonstrated that photobiomodulation therapy (PBMT) using low-level laser therapy and/or light-emitting diode therapy combined to static magnetic field (sMF) has ergogenic effects, improving muscular performance and accelerating postexercise recovery. However, many aspects related to these effects and its clinical applicability remain unknown. Therefore, the aim of this project is to evaluate the ergogenic effects of PBMT/sMF in detraining after a strength-training protocol.
METHODS AND ANALYSIS


The study will be a randomised, triple-blind, placebo-controlled clinical trial. Healthy male volunteers will be randomly distributed into four experimental groups: PBMT/sMF before training sessions + PBMT/sMF during detraining, PBMT/sMF before training sessions + placebo during detraining, placebo before training sessions + PBMT/sMF during detraining and placebo before training sessions + placebo during detraining. Strength-training sessions will be carried out over 12 weeks, and the detraining period will occur during the 4 weeks after. The muscular strength and the structural properties of quadriceps will be analysed.
ETHICS AND DISSEMINATION


This study was approved by the Research Ethics Committee of Nove de Julho University. The results from this study will be disseminated through scientific publications in international peer-reviewed journals and presented at national and international scientific meetings.
TRIAL REGISTRATION NUMBER


NCT03858179.",2019,"Healthy male volunteers will be randomly distributed into four experimental groups: PBMT/sMF before training sessions + PBMT/sMF during detraining, PBMT/sMF before training sessions + placebo during detraining, placebo before training sessions + PBMT/sMF during detraining and placebo before training sessions + placebo during detraining.","['Healthy male volunteers', 'humans']","['PBMT/sMF before training sessions + PBMT/sMF during detraining, PBMT/sMF before training sessions + placebo during detraining, placebo before training sessions + PBMT/sMF during detraining and placebo before training sessions + placebo', 'photobiomodulation therapy', 'placebo', 'PBMT/sMF', 'photobiomodulation therapy (PBMT) using low-level laser therapy and/or light-emitting diode therapy combined to static magnetic field (sMF']",['muscular performance and accelerating postexercise recovery'],"[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4019433', 'cui_str': 'LLLT'}, {'cui': 'C0279027', 'cui_str': 'Low-Power Laser Therapy'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C0563533', 'cui_str': 'Magnetic Fields'}]","[{'cui': 'C0442025', 'cui_str': 'Muscular (qualifier value)'}, {'cui': 'C0521110', 'cui_str': 'Accelerated (contextual qualifier) (qualifier value)'}]",,0.210322,"Healthy male volunteers will be randomly distributed into four experimental groups: PBMT/sMF before training sessions + PBMT/sMF during detraining, PBMT/sMF before training sessions + placebo during detraining, placebo before training sessions + PBMT/sMF during detraining and placebo before training sessions + placebo during detraining.","[{'ForeName': 'Paulo Roberto Vicente', 'Initials': 'PRV', 'LastName': 'de Paiva', 'Affiliation': 'Laboratory of Phototherapy and Innovative Technologies in Health (LaPIT), Postgraduate Program in Rehabilitation Sciences, Nove de Julho University, Sao Paulo, Brazil.'}, {'ForeName': 'Heliodora Leão', 'Initials': 'HL', 'LastName': 'Casalechi', 'Affiliation': 'Laboratory of Phototherapy and Innovative Technologies in Health (LaPIT), Postgraduate Program in Rehabilitation Sciences, Nove de Julho University, Sao Paulo, Brazil.'}, {'ForeName': 'Shaiane Silva', 'Initials': 'SS', 'LastName': 'Tomazoni', 'Affiliation': 'Masters and Doctoral Programs in Physical Therapy, Universidade Cidade de Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Caroline Dos Santos Monteiro', 'Initials': 'CDSM', 'LastName': 'Machado', 'Affiliation': 'Laboratory of Phototherapy and Innovative Technologies in Health (LaPIT), Postgraduate Program in Rehabilitation Sciences, Nove de Julho University, Sao Paulo, Brazil.'}, {'ForeName': 'Adriane Aver', 'Initials': 'AA', 'LastName': 'Vanin', 'Affiliation': 'Masters and Doctoral Programs in Physical Therapy, Universidade Cidade de Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Bruno Manfredini', 'Initials': 'BM', 'LastName': 'Baroni', 'Affiliation': 'Postgraduate Program in Rehabilitation Sciences, Universidade Federal de Ciencias da Saude de Porto Alegre, Porto Alegre, Brazil.'}, {'ForeName': 'Paulo de Tarso Camillo', 'Initials': 'PTC', 'LastName': 'de Carvalho', 'Affiliation': 'Laboratory of Phototherapy and Innovative Technologies in Health (LaPIT), Postgraduate Program in Rehabilitation Sciences, Nove de Julho University, Sao Paulo, Brazil.'}, {'ForeName': 'Ernesto Cesar Pinto', 'Initials': 'ECP', 'LastName': 'Leal-Junior', 'Affiliation': 'Laboratory of Phototherapy and Innovative Technologies in Health (LaPIT), Postgraduate Program in Rehabilitation Sciences, Nove de Julho University, Sao Paulo, Brazil ernesto.leal.junior@gmail.com.'}]",BMJ open,['10.1136/bmjopen-2019-030194']
523,32203207,Long-term cardiac outcomes of patients with HER2-positive breast cancer treated in the adjuvant lapatinib and/or trastuzumab Treatment Optimization Trial.,"BACKGROUND


Cardiotoxicity is the most significant adverse event associated with trastuzumab (T), the main component of HER2-positive breast cancer (BC) treatment. Less is known about the cardiotoxicity of dual HER2 blockade with T plus lapatinib (L), although this regimen is used in the metastatic setting.
METHODS


This is a sub-analysis of the ALTTO trial comparing adjuvant treatment options for patients with early HER2-positive BC. Patients randomised to either T or concomitant T + L were eligible. Cardiac events (CEs) rates were compared according to treatment arm.
RESULTS


With 6.9 years of median follow-up (FU) and 4190 patients, CE were observed in 363 (8.6%): 166 (7.9%) of patient in T + L arm vs. 197 (9.3%) in T arm (OR = 0.85 [95% CI, 0.68-1.05]). During anti-HER2 treatment 270 CE (6.4%) occurred while 93 (2.2%) were during FU (median time to onset = 6.6 months [IQR = 3.4-11.7]). While 265 CEs were asymptomatic (73%), 94 were symptomatic (26%) and four were cardiac deaths (1%). Recovery was observed in 301 cases (83.8%). Identified cardiac risk factors were: baseline LVEF < 55% (vs > 64%, OR 3.1 [95% CI 1.54-6.25]), diabetes mellitus (OR 1.85 [95% CI 1.25-2.75]), BMI > 30 kg/m 2  (vs < 25 mg/kg 2 , OR 2.21 [95% CI 1.40-3.49]), cumulative dose of doxorubicin ≥240 mg/m 2  (OR 1.36 [95% CI 1.01-1.82]) and of epirubicin≥ 480 mg/m 2  (OR 2.33 [95% CI 1.55-3.51]).
CONCLUSIONS


Dual HER2 blockade with T + L is a safe regimen from a cardiac perspective, but cardiac-focused history for proper patient selection is crucial.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov Identifier: NCT00490139 (registration date: 22/06/2007); EudraCT Number: 2006-000562-36 (registration date: 04/05/2007); Sponsor Protocol Number: BIG2-06 /EGF106708/N063D.",2020,"Cardiac events (CEs) rates were compared according to treatment arm.
","['patients with early HER2-positive BC', 'patients with HER2-positive breast cancer treated in the']","['trastuzumab (T', 'adjuvant lapatinib', 'T or concomitant T\u2009+\u2009L', 'doxorubicin']","['diabetes mellitus', 'Cardiac events (CEs) rates', 'Recovery', 'cardiac deaths']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C1506770', 'cui_str': 'lapatinib'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}]","[{'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0376297', 'cui_str': 'Cardiac Death'}]",,0.264623,"Cardiac events (CEs) rates were compared according to treatment arm.
","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Eiger', 'Affiliation': ""Institut Jules Bordet Institute and L'Université Libre de Bruxelles (U.L.B.), Brussels, Belgium.""}, {'ForeName': 'Noam F', 'Initials': 'NF', 'LastName': 'Pondé', 'Affiliation': ""Institut Jules Bordet Institute and L'Université Libre de Bruxelles (U.L.B.), Brussels, Belgium.""}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Agbor-Tarh', 'Affiliation': 'Frontier Science, Kingussie, United Kingdom.'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Moreno-Aspitia', 'Affiliation': 'Mayo Clinic, Jacksonville, FL, USA.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Piccart', 'Affiliation': ""Institut Jules Bordet Institute and L'Université Libre de Bruxelles (U.L.B.), Brussels, Belgium.""}, {'ForeName': 'Florentine S', 'Initials': 'FS', 'LastName': 'Hilbers', 'Affiliation': 'Breast International Group (BIG), Brussels, Belgium.'}, {'ForeName': 'Olena', 'Initials': 'O', 'LastName': 'Werner', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Saranya', 'Initials': 'S', 'LastName': 'Chumsri', 'Affiliation': 'Mayo Clinic, Jacksonville, FL, USA.'}, {'ForeName': 'Amylou', 'Initials': 'A', 'LastName': 'Dueck', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Scottsdale, AZ, USA.'}, {'ForeName': 'Judith R', 'Initials': 'JR', 'LastName': 'Kroep', 'Affiliation': 'Department of Medical Oncology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Gomez', 'Affiliation': 'Instituto Nacional de Enfermedades Neoplasicas, Lima, Peru.'}, {'ForeName': 'István', 'Initials': 'I', 'LastName': 'Láng', 'Affiliation': 'Istenhegyi Géndiagnosztika Private Health Center, Oncology Clinic, Budapest, Hungary.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Rodeheffer', 'Affiliation': 'Cardiovascular Department, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Ewer', 'Affiliation': 'MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Suter', 'Affiliation': 'Department of Cardiology, lnselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Evandro', 'Initials': 'E', 'LastName': 'de Azambuja', 'Affiliation': ""Institut Jules Bordet Institute and L'Université Libre de Bruxelles (U.L.B.), Brussels, Belgium. evandro.azambuja@bordet.be.""}]",British journal of cancer,['10.1038/s41416-020-0786-x']
524,31371315,A prospective trial of adjuvant therapy for high-risk uveal melanoma: assessing 5-year survival outcomes.,"BACKGROUND/AIMS


Survival after diagnosis of metastasis from uveal melanoma is poor. Identifying individuals at high risk for metastasis and developing adjuvant therapy to prevent clinically apparent metastasis could improve survival. We conducted an adjuvant trial of sequential, low-dose dacarbazine (DTIC) and interferon-alpha-2b (IFN-α-2b) in patients with cytogenetic high-risk uveal melanoma.
METHODS


Patients diagnosed with iris, ciliary body or choroidal melanoma with high-risk tumour cytogenetics (monosomy 3) were offered adjuvant treatment with low-dose DTIC and IFN-α-2b following primary therapy. Eligible but not enrolled patients were observed for comparison. DTIC was administered at 850 mg/m 2  intravenously on days 1 and 28. IFN-α-2b was administered at 3 million units three times a week subcutaneously for 24 weeks beginning at week 9. Hepatic imaging was performed prior to adjuvant therapy and then at least every 6 months. Survival data were collected for 5 years after enrolment.
RESULTS


33 patients (22%) were enrolled (treatment group), 29 (19%) were eligible but did not enrol (observation group) and 88 (59%) were not eligible. The 5-year metastasis-free survival (MFS) was 64%±9% for treated and 33%±10% for observed patients (p=0.05). The 5-year overall survival (OS) rate was 66%±9% for treated and 37%±10% for observed patients (p=0.02).
CONCLUSIONS


When adjusted for differences in age, tumour size and initial treatment, survival between treated and observed patients was no longer significant (p=0.56 MFS and p=0.92 OS). Differences in baseline tumour characteristics between treated and observed patients can influence interpretation of results.
TRIAL REGISTRATION NUMBER


NCT01100528.",2020,"When adjusted for differences in age, tumour size and initial treatment, survival between treated and observed patients was no longer significant (p=0.56 MFS and p=0.92 OS).","['Patients diagnosed with iris, ciliary body or choroidal melanoma with high-risk tumour cytogenetics (monosomy 3', 'patients with cytogenetic high-risk uveal melanoma', 'high-risk uveal melanoma', '33 patients (22%) were enrolled (treatment group), 29 (19%) were eligible but did not enrol (observation group) and 88 (59%) were not eligible']","['IFN-α-2b', 'adjuvant therapy', 'dacarbazine (DTIC) and interferon-alpha-2b (IFN-α-2b']","['Survival data', '5-year overall survival (OS) rate', '5-year metastasis-free survival (MFS', '5-year survival outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0022077', 'cui_str': 'Iris'}, {'cui': 'C0008779', 'cui_str': 'Corpus Ciliare'}, {'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}, {'cui': 'C0475283', 'cui_str': 'High risk tumor (tumor staging)'}, {'cui': 'C0010802', 'cui_str': 'Cytogenetic'}, {'cui': 'C0026499', 'cui_str': 'Monosomy'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0220633', 'cui_str': 'Uveal melanoma'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0302523', 'cui_str': 'Observation'}]","[{'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}, {'cui': 'C0010927', 'cui_str': 'Dacarbazine'}, {'cui': 'C0002199', 'cui_str': 'Interferon, Lymphoblastoid'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}]",33.0,0.505542,"When adjusted for differences in age, tumour size and initial treatment, survival between treated and observed patients was no longer significant (p=0.56 MFS and p=0.92 OS).","[{'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Binkley', 'Affiliation': 'Department of Ophthalmic Oncology, Cleveland Clinic, Cole Eye Institute, Cleveland, Ohio, USA.'}, {'ForeName': 'Pierre L', 'Initials': 'PL', 'LastName': 'Triozzi', 'Affiliation': 'Department of Ophthalmic Oncology, Cleveland Clinic, Cole Eye Institute, Cleveland, Ohio, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Rybicki', 'Affiliation': 'Department of Ophthalmic Oncology, Taussig Cancer Institute, Cleveland Clinic Foundation, Cleveland, Ohio, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Achberger', 'Affiliation': 'Department of Ophthalmic Oncology, Taussig Cancer Institute, Cleveland Clinic Foundation, Cleveland, Ohio, USA.'}, {'ForeName': 'Wayne', 'Initials': 'W', 'LastName': 'Aldrich', 'Affiliation': 'Department of Ophthalmic Oncology, Taussig Cancer Institute, Cleveland Clinic Foundation, Cleveland, Ohio, USA.'}, {'ForeName': 'Arun', 'Initials': 'A', 'LastName': 'Singh', 'Affiliation': 'Department of Ophthalmic Oncology, Cleveland Clinic, Cole Eye Institute, Cleveland, Ohio, USA singha@ccf.org.'}]",The British journal of ophthalmology,['10.1136/bjophthalmol-2019-314461']
525,31666270,Early PARacetamol (EPAR) trial: a study protocol for a randomised controlled trial of early paracetamol to promote closure of the ductus arteriosus in preterm infants.,"INTRODUCTION


The optimal management of patent ductus arteriosus (PDA) remains contentious. The medications used to treat PDA are often non-steroidal anti-inflammatory drugs, which are associated with a number of unwanted adverse effects. Paracetamol is a medication with an excellent safety profile in infants and has been suggested as a safe alternative medication in situations where other medications have failed or are contraindicated. There are limited data on the use of early, intravenous paracetamol in preterm infants.
METHODS AND ANALYSIS


This trial aims to address whether early treatment with paracetamol will reduce the number of infants requiring intervention for PDA. This is a randomised, double-blind, placebo-controlled trial in preterm infants <29 weeks' gestation. At 6 hours of life, infants with a ductus arteriosus >0.9 mm will be randomised to receive either (1) intravenous paracetamol at a dose of 15 mg/kg initially, followed by every 6 hours at a dose of 7.5 mg/kg for 5 days; or (2) intravenous 5% dextrose every 6 hours for 5 days. The primary outcome is the need for any intervention for management of PDA up to 5 days. Secondary outcomes include closure of the ductus arteriosus at 5 days, size of the ductus arteriosus, ductal reopening, systemic blood flow, mortality and significant morbidities. The target sample size of 100 infants yields >80% power, at the two-sided 5% level significance, to detect a 50% reduction in the need for intervention assuming that approximately 60% of infants in this study would otherwise have required intervention for PDA.
ETHICS AND DISSEMINATION


A report on the results of the planned analyses will be prepared. The results of the primary analysis of all end points will be presented at medical conferences and submitted for publication in peer-reviewed journals. Separate manuscripts pertaining to the second aim of the study may be written, and these will also be submitted for publication in peer-reviewed journals.
TRIAL REGISTRATION NUMBER


ACTRN12616001517460.",2019,"The target sample size of 100 infants yields >80% power, at the two-sided 5% level significance, to detect a 50% reduction in the need for intervention assuming that approximately 60% of infants in this study would otherwise have required intervention for PDA.
ETHICS AND DISSEMINATION


","[""preterm infants <29 weeks' gestation"", 'infants with a ductus arteriosus >0.9\u2009mm', 'infants requiring intervention for PDA', 'preterm infants', 'patent ductus arteriosus (PDA']","['paracetamol', 'Paracetamol', 'placebo']","['closure of the ductus arteriosus at 5\u2009days, size of the ductus arteriosus, ductal reopening, systemic blood flow, mortality and significant morbidities', 'need for any intervention for management of PDA up to 5\u2009days']","[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0013273', 'cui_str': 'Ductus Arteriosus'}, {'cui': 'C4068881', 'cui_str': 'Zero point nine'}, {'cui': 'C3495549', 'cui_str': 'Patent ductus arteriosus'}]","[{'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}, {'cui': 'C0013273', 'cui_str': 'Ductus Arteriosus'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}]",100.0,0.420203,"The target sample size of 100 infants yields >80% power, at the two-sided 5% level significance, to detect a 50% reduction in the need for intervention assuming that approximately 60% of infants in this study would otherwise have required intervention for PDA.
ETHICS AND DISSEMINATION


","[{'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Schindler', 'Affiliation': 'Newborn Care, Royal Hospital for Women, Randwick, New South Wales, Australia tim.schindler@health.nsw.gov.au.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Smyth', 'Affiliation': 'Newborn Care, Royal Hospital for Women, Randwick, New South Wales, Australia.'}, {'ForeName': 'Srinivas', 'Initials': 'S', 'LastName': 'Bolisetty', 'Affiliation': 'Newborn Care, Royal Hospital for Women, Randwick, New South Wales, Australia.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Michalowski', 'Affiliation': 'Newborn Care, Royal Hospital for Women, Randwick, New South Wales, Australia.'}, {'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Lui', 'Affiliation': 'Newborn Care, Royal Hospital for Women, Randwick, New South Wales, Australia.'}]",BMJ open,['10.1136/bmjopen-2019-031428']
526,32402773,The Effect of Cold Vapor and Ice Cube Absorption in the Early Postoperative Period on Sore Throat and Hoarseness Induced by Intubation.,"PURPOSE


This study aimed to determine the effect of cold vapor and ice cube absorption in the early postoperative period on sore throat and hoarseness induced by intubation.
DESIGN


This is a randomized controlled experimental study.
METHODS


Four groups (n = 30) were involved in the study: cold vapor application (group 1), ice cube absorption (group 2), ice cube absorption along with cold vapor application (group 3), and a control group (group 4). The sample consisted of 120 participants. The data were collected using the visual analog scale (VAS) and Stout's hoarseness scale postextubation (zeroth hour) and at the second, sixth, and 24th hours.
FINDINGS


After the interventions, the mean VAS scores for sore throat at the sixth postoperative hour were found to be 1.50 ± 1.71, 1.16 ± 1.08, and 1.30 ± 1.62 in group 1, group 2, and group 3, respectively. The mean VAS score for sore throat of group 4 was found to be 3.70 ± 1.89. The decrease in the VAS score for the sixth postoperative hour was ranked from highest to lowest as follows: ice cube absorption group, ice cube absorption along with cold vapor application group, and cold vapor application group. There was no significant difference between application groups in terms of mean VAS scores; however, it was found that mean VAS scores of all application groups were lower than that of control group, and there was a significant difference between them (P < .05). We found that at the sixth postoperative hour after intervention, 33.3% of group 1, 36.7% of group 2, 30% of group 3, and 46.7% of group 4 had hoarseness. No significant difference was found between groups, in terms of hoarseness scores of patients in the sixth postoperative hour after intervention (P > .05).
CONCLUSIONS


Cold vapor application, ice cube absorption, and ice cube absorption along with cold vapor application were effective in reducing sore throat but were ineffective as treatment for hoarseness.",2020,"No significant difference was found between groups, in terms of hoarseness scores of patients in the sixth postoperative hour after intervention (P > .05).
","['Four groups (n\xa0= 30) were involved in the study', 'Sore Throat and Hoarseness Induced by Intubation', '120 participants', 'sore throat and hoarseness induced by intubation']","['cold vapor and ice cube absorption', 'cold vapor application (group 1), ice cube absorption (group 2), ice cube absorption along with cold vapor application', 'Cold Vapor and Ice Cube Absorption']","['VAS score', 'hoarseness', 'hoarseness scores', 'mean VAS scores', ""visual analog scale (VAS) and Stout's hoarseness scale postextubation (zeroth hour) and at the second, sixth, and 24th hours"", 'mean VAS score']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0031350', 'cui_str': 'Pharyngitis'}, {'cui': 'C0019825', 'cui_str': 'Hoarse'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C4319550', 'cui_str': '120'}]","[{'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0597635', 'cui_str': 'Vapor'}, {'cui': 'C0020746', 'cui_str': 'Ice'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}]","[{'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0019825', 'cui_str': 'Hoarse'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0452470', 'cui_str': 'Stout'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0205440', 'cui_str': 'Sixth'}]",120.0,0.0248688,"No significant difference was found between groups, in terms of hoarseness scores of patients in the sixth postoperative hour after intervention (P > .05).
","[{'ForeName': 'Muazzez', 'Initials': 'M', 'LastName': 'Şahbaz', 'Affiliation': 'Department of Fundamentals of Nursing, Nursing Faculty, Aydın Adnan Menderes University, Aydın, Turkey. Electronic address: muazzez_sahbaz@hotmail.com.'}, {'ForeName': 'Leyla', 'Initials': 'L', 'LastName': 'Khorshid', 'Affiliation': 'Department of Fundamentals of Nursing, Nursing Faculty, Ege University, İzmir, Turkey.'}]",Journal of perianesthesia nursing : official journal of the American Society of PeriAnesthesia Nurses,['10.1016/j.jopan.2019.12.007']
527,32401335,Breast shield design impacts milk removal dynamics during pumping: A randomized controlled non-inferiority trial.,"INTRODUCTION


While many studies have investigated the importance of optimizing pumping patterns for milk removal, the influence of breast shield design on milk removal has not been the focus of extensive investigation. This study aimed to determine the effectiveness of breast shields with either a 105° or a 90° flange opening angle on breast drainage and milk volume expressed during pumping.
MATERIAL AND METHODS


This study was a cross-over, randomized controlled non-inferiority trial (Registration; NCT03091985). Mothers (n = 49) of breastfeeding infants participated in the study over two study sessions. Participants were randomly assigned to pump both breasts simultaneously for 15 minutes with either the 105° or 90° breast shield in the first session, and the other shield in the second session. Effectiveness (breast drainage) and efficiency (volume expressed) of both breast shields were assessed after 15 minutes of pumping. Intention-to-treat and per protocol analyses were performed to determine if the 105° breast shield was non-inferior to the 90° breast shield for breast drainage and volume expressed. Perceived comfort was assessed via questionnaire.
RESULTS


The 105° breast shield was both non-inferior and superior compared to the standard 90° shield for breast drainage (intention-to-treat, 3.87% (0.01-7.72), P = .049) and volume expressed (intention-to-treat, 9.14 mL (1.37-16.91), P=.02). In addition, the 105° shield was rated as feeling more comfortable (P < .001) and as having an improved fit to the breast (P < .001) compared to the 90° shield.
CONCLUSIONS


Expressing with the 105° breast shield was more efficient, effective and comfortable compared to the 90° shield. Breast shield design can significantly impact pumping outcomes, and an opening angle of 105° improves both the dynamics and comfort of milk removal.",2020,"In addition, the 105° shield was rated as feeling more comfortable (p<.001) and as having an improved fit to the breast (p<.001) compared to the 90° shield.
",['Mothers (n=49) of breastfeeding infants participated in the study over two study sessions'],[],"['Effectiveness (breast drainage) and efficiency (volume expressed) of both breast shields', 'feeling more comfortable (p<.001) and as having an improved fit to the breast', 'Perceived comfort']","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0222605', 'cui_str': 'Both breasts'}, {'cui': 'C0183251', 'cui_str': 'Shield'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",,0.0633338,"In addition, the 105° shield was rated as feeling more comfortable (p<.001) and as having an improved fit to the breast (p<.001) compared to the 90° shield.
","[{'ForeName': 'Vanessa S', 'Initials': 'VS', 'LastName': 'Sakalidis', 'Affiliation': 'Medela AG, Baar, Switzerland.'}, {'ForeName': 'Lennart', 'Initials': 'L', 'LastName': 'Ivarsson', 'Affiliation': 'Medela AG, Baar, Switzerland.'}, {'ForeName': 'Alan G', 'Initials': 'AG', 'LastName': 'Haynes', 'Affiliation': 'Clinical Trials Unit (CTU) Bern, Faculty of Medicine, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Jäger', 'Affiliation': 'Medela AG, Baar, Switzerland.'}, {'ForeName': 'Nania G', 'Initials': 'NG', 'LastName': 'Schärer-Hernández', 'Affiliation': 'Medela AG, Baar, Switzerland.'}, {'ForeName': 'Leon R', 'Initials': 'LR', 'LastName': 'Mitoulas', 'Affiliation': 'Medela AG, Baar, Switzerland.'}, {'ForeName': 'Danielle K', 'Initials': 'DK', 'LastName': 'Prime', 'Affiliation': 'Medela AG, Baar, Switzerland.'}]",Acta obstetricia et gynecologica Scandinavica,['10.1111/aogs.13897']
528,32401144,"Rich environments, dull experiences: how environment can exacerbate the effect of constraint on the experience of boredom.","We examined the hypothesis that boredom is likely to occur when opportunity costs are high; that is, when there is a high potential value of engaging in activities other than the researcher-assigned activity. To this end, participants were either placed in a room with many possible affordances (e.g. a laptop, puzzle, etc.;  affordances condition; n = 121 ), or they were ushered into an empty room ( control condition; n = 107 ). In both conditions participants were instructed to entertain themselves with only their thoughts (hence, participants in the affordances condition were to refrain from engaging with the available options). As predicted, participants in the affordances condition reported higher levels of boredom compared with those in the control condition. Results suggest that under some conditions, environments that afford alternative activities may be  more  boring than those that are void of such activities.",2020,"As predicted, participants in the affordances condition reported higher levels of boredom compared with those in the control condition.",[],[],['levels of boredom'],[],[],"[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0006019', 'cui_str': 'Boredom'}]",,0.021607,"As predicted, participants in the affordances condition reported higher levels of boredom compared with those in the control condition.","[{'ForeName': 'Andriy A', 'Initials': 'AA', 'LastName': 'Struk', 'Affiliation': 'Department of Psychology, University of Waterloo, Waterloo, ON, Canada.'}, {'ForeName': 'Abigail A', 'Initials': 'AA', 'LastName': 'Scholer', 'Affiliation': 'Department of Psychology, University of Waterloo, Waterloo, ON, Canada.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Danckert', 'Affiliation': 'Department of Psychology, University of Waterloo, Waterloo, ON, Canada.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Seli', 'Affiliation': 'Department of Psychology and Neuroscience, Duke University, Durham, NC, USA.'}]",Cognition & emotion,['10.1080/02699931.2020.1763919']
529,32206483,Linagliptin and cardiorenal outcomes in Asians with type 2 diabetes mellitus and established cardiovascular and/or kidney disease: subgroup analysis of the randomized CARMELINA ®  trial.,"Objective


Linagliptin, a dipeptidyl peptidase-4 inhibitor, demonstrated cardiovascular and renal safety in type 2 diabetes mellitus (T2DM) patients with established cardiovascular disease (CVD) with albuminuria and/or kidney disease in the multinational CARMELINA ®  trial. We investigated the effects of linagliptin in Asian patients in CARMELINA ® .
Methods


T2DM patients with HbA1c 6.5-10.0% and established CVD with urinary albumin-to-creatinine ratio (UACR) > 30 mg/g, and/or prevalent kidney disease (estimated glomerular filtration rate [eGFR] 15-< 45 ml/min/1.73 m 2  or ≥ 45-75 with UACR > 200 mg/g), were randomized to linagliptin or placebo added to usual care. The primary endpoint was time to first occurrence of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke (3-point MACE).
Results


Of the 6979 patients, 555 (8.0%) were Asians living in Asia. During a median follow-up of 2.2 years, 3-point MACE occurred in 29/272 (10.7%) and 33/283 (11.7%) of linagliptin and placebo patients, respectively (hazard ratio [HR] 0.90; 95% confidence interval [CI] 0.55-1.48), consistent with the overall population (HR 1.02; 95% CI 0.89-1.17;  P  value for treatment-by-region interaction: 0.3349). Similar neutrality in Asian patients was seen for other cardiorenal events including the secondary kidney endpoint of death from renal failure, progression to end-stage kidney disease, or ≥ 40% eGFR decrease (HR 0.96; 95% CI 0.58-1.59). Linagliptin was associated with a nominal decrease in the risk of hospitalization for heart failure (HR 0.47; 95% CI 0.24-0.95). Overall in Asian patients, linagliptin had an adverse event rate similar to placebo, consistent with the overall population.
Conclusions


Linagliptin showed cardiovascular and renal safety in Asian patients with T2DM and established CVD with albuminuria and/or kidney disease.",2020,Linagliptin was associated with a nominal decrease in the risk of hospitalization for heart failure (HR 0.47; 95% CI 0.24-0.95).,"['6979 patients, 555 (8.0%) were Asians living in Asia', 'Asian patients with T2DM and established CVD with albuminuria and/or kidney disease', 'Methods\n\n\nT2DM patients with HbA1c 6.5-10.0% and established CVD with urinary albumin-to-creatinine ratio (UACR)\u2009', 'Asian patients in CARMELINA ® ', 'type 2 diabetes mellitus (T2DM) patients with established cardiovascular disease (CVD) with albuminuria and/or kidney disease', 'Asians with type 2 diabetes mellitus and established cardiovascular and/or kidney disease']","['linagliptin', 'Linagliptin', 'placebo', 'linagliptin or placebo']","['glomerular filtration rate [eGFR', '3-point MACE', 'adverse event rate', 'time to first occurrence of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke (3-point MACE', 'secondary kidney endpoint of death from renal failure, progression to end-stage kidney disease', 'cardiovascular and renal safety', 'risk of hospitalization for heart failure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517810', 'cui_str': 'Five hundred and fifty-five'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0022658', 'cui_str': 'Kidney Diseases'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C2746078', 'cui_str': 'Linagliptin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C0349381', 'cui_str': 'Mace (substance)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0035078', 'cui_str': 'Kidney Failure'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0022661', 'cui_str': 'End-Stage Kidney Disease'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}]",6979.0,0.425414,Linagliptin was associated with a nominal decrease in the risk of hospitalization for heart failure (HR 0.47; 95% CI 0.24-0.95).,"[{'ForeName': 'Nobuya', 'Initials': 'N', 'LastName': 'Inagaki', 'Affiliation': '1Department of Diabetes, Endocrinology and Nutrition, Graduate School of Medicine, Kyoto University, 54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, 606-8507 Japan.'}, {'ForeName': 'Wenying', 'Initials': 'W', 'LastName': 'Yang', 'Affiliation': ""2Department of Endocrinology, China-Japan Friendship Hospital, Beijing, People's Republic of China.""}, {'ForeName': 'Hirotaka', 'Initials': 'H', 'LastName': 'Watada', 'Affiliation': '3Department of Metabolism and Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Linong', 'Initials': 'L', 'LastName': 'Ji', 'Affiliation': ""4Department of Endocrinology and Metabolism, Peking University People's Hospital, Beijing, People's Republic of China.""}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Schnaidt', 'Affiliation': '5Boehringer Ingelheim Pharma GmbH & Co KG, Biberach, Germany.'}, {'ForeName': 'Egon', 'Initials': 'E', 'LastName': 'Pfarr', 'Affiliation': '6Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim, Germany.'}, {'ForeName': 'Tomoo', 'Initials': 'T', 'LastName': 'Okamura', 'Affiliation': '7Nippon Boehringer Ingelheim Co., Ltd, Tokyo, Japan.'}, {'ForeName': 'Odd Erik', 'Initials': 'OE', 'LastName': 'Johansen', 'Affiliation': '8Boehringer Ingelheim Norway KS, Asker, Norway.'}, {'ForeName': 'Jyothis T', 'Initials': 'JT', 'LastName': 'George', 'Affiliation': '9Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Maximilian', 'Initials': 'M', 'LastName': 'von Eynatten', 'Affiliation': '9Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Rosenstock', 'Affiliation': '10Dallas Diabetes Research Center at Medical City, University of Texas Southwestern Medical Center, Dallas, TX USA.'}, {'ForeName': 'Vlado', 'Initials': 'V', 'LastName': 'Perkovic', 'Affiliation': '11George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Wanner', 'Affiliation': '12Division of Nephrology, Department of Medicine, Würzburg University Clinic, Würzburg, Germany.'}, {'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Cooper', 'Affiliation': '13Department of Diabetes, Central Clinical School, Monash University, Melbourne, Australia.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Alexander', 'Affiliation': '14Duke Clinical Research Institute, Duke Health, Durham, NC USA.'}, {'ForeName': 'Issei', 'Initials': 'I', 'LastName': 'Komuro', 'Affiliation': '15Department of Cardiovascular Medicine, University of Tokyo Hospital, Tokyo, Japan.'}, {'ForeName': 'Masaomi', 'Initials': 'M', 'LastName': 'Nangaku', 'Affiliation': '16Division of Nephrology and Endocrinology, The University of Tokyo Graduate School of Medicine, Tokyo, Japan.'}]",Diabetology international,['10.1007/s13340-019-00412-x']
530,31590688,An electronic family health history tool to identify and manage patients at increased risk for colorectal cancer: protocol for a randomized controlled trial.,"BACKGROUND


Colorectal cancer is the fourth most commonly diagnosed cancer in the United States. Approximately 3-10% of the population has an increased risk for colorectal cancer due to family history and warrants more frequent or intensive screening. Yet, < 50% of that high-risk population receives guideline-concordant care. Systematic collection of family health history and decision support may improve guideline-concordant screening for patients at increased risk of colorectal cancer. We seek to test the effectiveness of a web-based, systematic family health history collection tool and decision support platform (MeTree) to improve risk assessment and appropriate management of colorectal cancer risk among patients in the Department of Veterans Affairs primary care practices.
METHODS


In this ongoing randomized controlled trial, primary care providers at the Durham Veterans Affairs Health Care System and the Madison VA Medical Center are randomized to immediate intervention or wait-list control. Veterans are eligible if assigned to enrolled providers, have an upcoming primary care appointment, and have no conditions that would place them at increased risk for colorectal cancer (such as personal history, adenomatous polyps, or inflammatory bowel disease). Those with a recent lower endoscopy (e.g. colonoscopy, sigmoidoscopy) are excluded. Immediate intervention patients put their family health history information into a web-based platform, MeTree, which provides both patient- and provider-facing decision support reports. Wait-list control patients access MeTree 12 months post-consent. The primary outcome is the risk-concordant colorectal cancer screening referral rate obtained via chart review. Secondary outcomes include patient completion of risk management recommendations (e.g. colonoscopy) and referral for genetic consultation. We will also conduct an economic analysis and an assessment of providers' experience with MeTree clinical decision support recommendations to inform future implementation efforts if the intervention is found to be effective.
DISCUSSION


This trial will assess the feasibility and effectiveness of patient-collected family health history linked to decision support to promote risk-appropriate screening in a large healthcare system such as the Department of Veterans Affairs.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT02247336 . Registered on 25 September 2014.",2019,Approximately 3-10% of the population has an increased risk for colorectal cancer due to family history and warrants more frequent or intensive screening.,"['colorectal cancer risk among patients in the Department of Veterans Affairs primary care practices', 'primary care providers at the Durham Veterans Affairs Health Care System and the Madison VA Medical Center', 'patients at increased risk of colorectal cancer', 'Veterans are eligible if assigned to enrolled providers, have an upcoming primary care appointment, and have no conditions that would place them at increased risk for colorectal cancer (such as personal history, adenomatous polyps, or inflammatory bowel disease']","['web-based, systematic family health history collection tool and decision support platform (MeTree', 'immediate intervention or wait-list control']","['patient completion of risk management recommendations (e.g. colonoscopy) and referral for genetic consultation', 'risk-concordant colorectal cancer screening referral rate obtained via chart review']","[{'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C2735026', 'cui_str': 'Primary care provider (occupation)'}, {'cui': 'C0454851', 'cui_str': 'Durham (geographic location)'}, {'cui': 'C0018696', 'cui_str': 'Health Care Systems'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0424945', 'cui_str': 'Social / personal history observable'}, {'cui': 'C0206677', 'cui_str': 'Adenomatous Polyps'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory Bowel Diseases'}]","[{'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0220922', 'cui_str': 'systematics'}, {'cui': 'C0241889', 'cui_str': 'Family Medical History'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035649', 'cui_str': 'Risk Management'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C2585524', 'cui_str': 'Referral for'}, {'cui': 'C0017399', 'cui_str': 'genetics'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0541653', 'cui_str': 'Chart review'}]",,0.144353,Approximately 3-10% of the population has an increased risk for colorectal cancer due to family history and warrants more frequent or intensive screening.,"[{'ForeName': 'Karen M', 'Initials': 'KM', 'LastName': 'Goldstein', 'Affiliation': 'Durham Center of Innovation to Accelerate Discovery and Practice Transformation, Durham Veterans Affairs Health Care System, 508 Fulton Street, Durham, NC, 27705, USA. karen.goldstein@duke.edu.'}, {'ForeName': 'Deborah A', 'Initials': 'DA', 'LastName': 'Fisher', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'R Ryanne', 'Initials': 'RR', 'LastName': 'Wu', 'Affiliation': 'Division of General Internal Medicine, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Lori A', 'Initials': 'LA', 'LastName': 'Orlando', 'Affiliation': 'Division of General Internal Medicine, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Cynthia J', 'Initials': 'CJ', 'LastName': 'Coffman', 'Affiliation': 'Durham Center of Innovation to Accelerate Discovery and Practice Transformation, Durham Veterans Affairs Health Care System, 508 Fulton Street, Durham, NC, 27705, USA.'}, {'ForeName': 'Janet M', 'Initials': 'JM', 'LastName': 'Grubber', 'Affiliation': 'Durham Center of Innovation to Accelerate Discovery and Practice Transformation, Durham Veterans Affairs Health Care System, 508 Fulton Street, Durham, NC, 27705, USA.'}, {'ForeName': 'Tejinder', 'Initials': 'T', 'LastName': 'Rakhra-Burris', 'Affiliation': 'Center for Applied Genomics and Precision Medicine, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Wang', 'Affiliation': 'Durham Center of Innovation to Accelerate Discovery and Practice Transformation, Durham Veterans Affairs Health Care System, 508 Fulton Street, Durham, NC, 27705, USA.'}, {'ForeName': 'Maren T', 'Initials': 'MT', 'LastName': 'Scheuner', 'Affiliation': 'Division of Medical Genetics, University of California at San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Sperber', 'Affiliation': 'Durham Center of Innovation to Accelerate Discovery and Practice Transformation, Durham Veterans Affairs Health Care System, 508 Fulton Street, Durham, NC, 27705, USA.'}, {'ForeName': 'Santanu K', 'Initials': 'SK', 'LastName': 'Datta', 'Affiliation': 'Division of General Internal Medicine, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Nelson', 'Affiliation': 'IDEAS Center, VA Salt Lake City Healthcare System, Salt Lake City, UT, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Strawbridge', 'Affiliation': 'Durham Center of Innovation to Accelerate Discovery and Practice Transformation, Durham Veterans Affairs Health Care System, 508 Fulton Street, Durham, NC, 27705, USA.'}, {'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Provenzale', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Hauser', 'Affiliation': 'Durham Cooperative Studies Program Epidemiology Center, Durham Veterans Affairs Health Care System, Durham, NC, USA.'}, {'ForeName': 'Corrine I', 'Initials': 'CI', 'LastName': 'Voils', 'Affiliation': 'William S Middleton Memorial Veterans Hospital, Madison, WI, USA.'}]",Trials,['10.1186/s13063-019-3659-y']
531,32402604,Group mindfulness-based therapy for persecutory delusions: A pilot randomised controlled trial.,,2020,,['persecutory delusions'],[],[],"[{'cui': 'C0349398', 'cui_str': 'Paranoid delusion'}]",[],[],,0.125109,,"[{'ForeName': 'Lyn', 'Initials': 'L', 'LastName': 'Ellett', 'Affiliation': 'Department of Psychology, Royal Holloway, University of London, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Eryna', 'Initials': 'E', 'LastName': 'Tarant', 'Affiliation': 'Surrey and Borders Partnership NHS Foundation Trust, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Kouimtsidis', 'Affiliation': 'Surrey and Borders Partnership NHS Foundation Trust, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Kingston', 'Affiliation': 'Department of Psychology, Royal Holloway, University of London, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Vivarelli', 'Affiliation': 'Surrey and Borders Partnership NHS Foundation Trust, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Jeewaka', 'Initials': 'J', 'LastName': 'Mendis', 'Affiliation': 'University of Surrey, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Chadwick', 'Affiliation': 'Department of Psychology, University of Bath, United Kingdom of Great Britain and Northern Ireland. Electronic address: pdjc20@bath.ac.uk.'}]",Schizophrenia research,['10.1016/j.schres.2020.04.023']
532,32404539,Counteracting effect of verbal ratings of sleepiness on dual task interference.,"The aim of the present study was to demonstrate the effect of verbal ratings on arousal in the electroencephalogram (EEG) and psychomotor vigilance test (PVT) performance. Thirty participants underwent the PVT for 40 min in three experimental conditions: (1) Rating condition, in which they verbally rated subjective sleepiness with Karolinska sleepiness scale, following pure tone sound played every 20 s during PVT, (2) No-rating condition, in which they underwent PVT with the similar sound as the Rating experiment but without the verbal rating task, and (3) Control condition, in which they underwent PVT with a no-sound stimulus and without the verbal rating task. The results show that during the first half of the task epoch, alpha power density was lower in the Rating than in the No-rating condition, while performance was not different between the conditions. During the second half of the task epoch, performance was better in the Non-rating than in the Rating condition, but no difference in the alpha power density. These results suggest that performance deterioration could be masked by the arousal effect of the dual task itself. It could also explain why the PVT performance and arousal in EEG sometimes dissociate, particularly in dual task situations.",2020,"During the second half of the task epoch, performance was better in the Non-rating than in the Rating condition, but no difference in the alpha power density.",['Thirty participants underwent the'],"['pure tone sound played every 20 s during PVT, (2) No-rating condition, in which they underwent PVT with the similar sound as the Rating experiment but without the verbal rating task, and (3) Control condition, in which they underwent PVT with a no-sound stimulus and without the verbal rating task', 'PVT']","['alpha power density', 'verbal ratings on arousal in the electroencephalogram (EEG) and psychomotor vigilance test (PVT) performance', 'verbal ratings of sleepiness on dual task interference']","[{'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C0037709', 'cui_str': 'Sonic Radiation'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0043012', 'cui_str': 'Wakefulness'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0233535', 'cui_str': 'Butting'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332288', 'cui_str': 'Without'}]","[{'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0043012', 'cui_str': 'Wakefulness'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}]",30.0,0.0278604,"During the second half of the task epoch, performance was better in the Non-rating than in the Rating condition, but no difference in the alpha power density.","[{'ForeName': 'Kosuke', 'Initials': 'K', 'LastName': 'Kaida', 'Affiliation': 'Human Informatics and Interaction Research Institute, National Institute of Advanced Industrial Science and Technology (AIST), Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Abe', 'Affiliation': 'International Institute for Integrative Sleep Medicine (WPI-IIIS), Japan.'}, {'ForeName': 'Sunao', 'Initials': 'S', 'LastName': 'Iwaki', 'Affiliation': 'Human Informatics and Interaction Research Institute, National Institute of Advanced Industrial Science and Technology (AIST), Japan.'}]",Industrial health,['10.2486/indhealth.2020-0005']
533,32404742,Bovine Lactoferrin Supplementation Does Not Disrupt Microbiota Development in Preterm Infants Receiving Probiotics.,"OBJECTIVE


The aim of the study was to assess whether bovine lactoferrin (bLf) supplementation disrupts intestinal microbiota development in preterm infants less than 31 weeks gestational age receiving prophylactic probiotic administration.
METHODS


Subjects were recruited from the LACUNA trial (ISRCTN66482337), designed to assess bLf safety. These subjects were randomized to daily receive either probiotic supplements or probiotics supplemented with 100 mg bLf mixed with their feeds (human milk or formula). Stools were collected weekly from enrolled infants for 1 month and the microbiota characterized using V6-16S rRNA gene amplicon profiling.
RESULTS


Infants' microbiomes did not increase in alpha diversity over time in both feeding interventions. Infants receiving bLf supplementation had overall higher species richness as compared with those not receiving these supplements and lactoferrin supplementation had differing effects on infant microbiota species richness depending on the infant's gestational age. Principal co-ordinate analysis revealed that the infant microbiotas did not separate by intervention group, gestational age bracket at birth or sampling time and the main factor dictating sample clustering was infant identity. There were very few detectable differences in taxa relative abundance or functional gene content between the microbiotas in the 2 study groups.
CONCLUSIONS


Bovine lactoferrin supplementation has minimal impact on microbiota composition/function in preterm infants receiving probiotics, and therefore, is unlikely to disrupt microbiota development.",2020,"There were very few detectable differences in taxa relative abundance or functional gene content between the microbiotas in the two study groups.
","['preterm infants receiving probiotics', 'Preterm Infants Receiving Probiotics', 'preterm infants less than 31 weeks gestational age receiving prophylactic probiotic administration', 'Subjects']","['bovine lactoferrin supplementation', 'Bovine lactoferrin supplementation', 'lactoferrin supplementation', 'Bovine Lactoferrin Supplementation', 'probiotic supplements or probiotics supplemented with 100\u200amg bovine lactoferrin mixed with their feeds (human milk or formula']","['intestinal microbiota development', 'infant microbiota species richness', 'bovine lactoferrin safety', 'alpha diversity']","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C1440867', 'cui_str': 'Bovine lactoferrin'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0022942', 'cui_str': 'Lactoferrin'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0026140', 'cui_str': 'Breast milk'}]","[{'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C1440867', 'cui_str': 'Bovine lactoferrin'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}]",,0.0920702,"There were very few detectable differences in taxa relative abundance or functional gene content between the microbiotas in the two study groups.
","[{'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Grzywacz', 'Affiliation': 'Ottawa Institute of Systems Biology, Department of Biochemistry, Microbiology and Immunology, University of Ottawa, Ottawa, Ontario.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Butcher', 'Affiliation': 'Ottawa Institute of Systems Biology, Department of Biochemistry, Microbiology and Immunology, University of Ottawa, Ottawa, Ontario.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Ottawa Institute of Systems Biology, Department of Biochemistry, Microbiology and Immunology, University of Ottawa, Ottawa, Ontario.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Barrington', 'Affiliation': 'Department of Neonatology, CHU Sainte Justine, Montreal, Quebec, Canada.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Mohamed', 'Affiliation': 'Department of Neonatology, CHU Sainte Justine, Montreal, Quebec, Canada.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Stintzi', 'Affiliation': 'Ottawa Institute of Systems Biology, Department of Biochemistry, Microbiology and Immunology, University of Ottawa, Ottawa, Ontario.'}]",Journal of pediatric gastroenterology and nutrition,['10.1097/MPG.0000000000002734']
534,32183779,HIV-exposed infant follow-up in Mozambique: formative research findings for the design of a cluster randomized controlled trial to improve testing and ART initiation.,"BACKGROUND


Early infant diagnosis (EID) of HIV-exposed and initiation of HIV-positive infants on anti-retroviral therapy (ART) requires a well-coordinated cascade of care. Loss-to-follow-up (LTFU) can occur at multiple steps and effective EID is impeded by human resource constraints, difficulty with patient tracking, and long waiting periods. The objective of this research was to conduct formative research to guide the development of an intervention to improve the pediatric HIV care cascade in central Mozambique. The study was conducted in Manica and Sofala Provinces where the adult HIV burden is higher than the national average. The research focused on 3 large clinics in each province, along the highly populated Beira corridor.
METHODS


The research was conducted in 2014 over 3 months at six facilities and consisted of 1) patient flow mapping and collection of health systems data from postpartum, child-at-risk, and ART service registries, 2) measurement of clinic waiting times, and 3) patient and health worker focus groups.
RESULTS


HIV testing and ART initiation coverage for mothers tends to be high, but EID and pediatric ART initiation are hampered by lack of patient tracking, long waiting times, and inadequate counseling to navigate the care cascade. About 76% of HIV-positive infants were LTFU and did not initiate ART.
CONCLUSIONS


Effective interventions to reduce LTFU in EID and improve pediatric ART initiation should focus on patient tracking, active follow-up of defaulting patients, reduction in EID turn-around times for PCR results, and initiation of ART by nurses in child-at-risk services.
TRIAL REGISTRATION


Retrospectively registered, ISRCTN67747315, July 24, 2019.",2020,"Loss-to-follow-up (LTFU) can occur at multiple steps and effective EID is impeded by human resource constraints, difficulty with patient tracking, and long waiting periods.","['2014 over 3\u2009months at six facilities and consisted of 1) patient flow mapping and collection of health systems data from postpartum, child-at-risk, and ART service registries, 2) measurement of clinic waiting times, and 3) patient and health worker focus groups', 'Manica and Sofala Provinces where the adult HIV burden is higher than the national average']",[],[],"[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0425119', 'cui_str': 'Child at risk (finding)'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0016400', 'cui_str': 'Focus Groups'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",[],[],,0.0885071,"Loss-to-follow-up (LTFU) can occur at multiple steps and effective EID is impeded by human resource constraints, difficulty with patient tracking, and long waiting periods.","[{'ForeName': 'Lúcia', 'Initials': 'L', 'LastName': 'Vieira', 'Affiliation': 'Ministry of Health, Centro de Investigação Operacional da Beira, Institute Nacional de Saúde, 1323 Correia de Brito Street, Ponta-gêa Health Center Building, Beira, Sofala, Mozambique. luciadacostavieira@gmail.com.'}, {'ForeName': 'Arlete Miloque', 'Initials': 'AM', 'LastName': 'Mahumane', 'Affiliation': 'Ministry of Health, Centro de Investigação Operacional da Beira, Institute Nacional de Saúde, 1323 Correia de Brito Street, Ponta-gêa Health Center Building, Beira, Sofala, Mozambique.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Napua', 'Affiliation': 'Ministry of Health, Centro de Investigação Operacional da Beira, Institute Nacional de Saúde, 1323 Correia de Brito Street, Ponta-gêa Health Center Building, Beira, Sofala, Mozambique.'}, {'ForeName': 'Falume', 'Initials': 'F', 'LastName': 'Chale', 'Affiliation': 'Ministry of Health, Centro de Investigação Operacional da Beira, Institute Nacional de Saúde, 1323 Correia de Brito Street, Ponta-gêa Health Center Building, Beira, Sofala, Mozambique.'}, {'ForeName': 'João Luís', 'Initials': 'JL', 'LastName': 'Manuel', 'Affiliation': 'Ministry of Health, Centro de Investigação Operacional da Beira, Institute Nacional de Saúde, 1323 Correia de Brito Street, Ponta-gêa Health Center Building, Beira, Sofala, Mozambique.'}, {'ForeName': 'Jessica Greenberg', 'Initials': 'JG', 'LastName': 'Cowan', 'Affiliation': 'School of Nursing, University of Washington, Seattle, USA.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Sherr', 'Affiliation': 'School of Nursing, University of Washington, Seattle, USA.'}, {'ForeName': 'Rachel R', 'Initials': 'RR', 'LastName': 'Chapman', 'Affiliation': 'Department of Anthropology, University of Washington, Seattle, USA.'}, {'ForeName': 'James T', 'Initials': 'JT', 'LastName': 'Pfeiffer', 'Affiliation': 'School of Nursing, University of Washington, Seattle, USA.'}]",BMC health services research,['10.1186/s12913-020-5051-8']
535,32401873,Skin picking treatment with the Rothbaum cognitive behavioral therapy protocol: a randomized clinical trial.,"INTRODUCTION


Although behavioral therapies can effectively treat skin picking disorder (SPD), there is no standardized treatment for improving SPD and its comorbidities and there is no group intervention option. This trial aimed to adapt the Rothbaum trichotillomania protocol to SPD (Study 1) and test its efficacy for treating SPD and comorbidities in individual and group formats (Study 2).
METHODS


The adapted protocol was applied to 16 SPD patients, who were allocated to group or individual treatment (Study 1). Afterwards, 54 patients were randomly allocated to treatment in an individual (n=27) or group format (n=27) (Study 2). In both studies, assessments of SPD severity, anxiety, depression, clinical status and skin lesion severity were performed at baseline and the endpoint.
RESULTS


The adapted protocol was feasible in both treatment modalities (Study 1) and led to high SPD remission rates (individual 63%; group 52%), with no significant difference between intervention types (p = 0.4) (Study 2). SPD, anxiety, and depression symptoms and objective patient lesion measures improved after treatment. There was large effect size for SPD symptom improvement in both treatment types (Cohen's d: group = 0.88; individual = 1.15) (Study 2).
CONCLUSION


The adapted Rothbaum protocol was effective for SPD remission, comorbidities, and skin lesions, both in individual and group formats.
CLINICAL TRIAL REGISTRATION


NCT03182478.",2020,"The adapted Rothbaum protocol was effective for SPD remission, comorbidities, and skin lesions, both in individual and group formats.
","['16 SPD patients', '54 patients were randomly allocated to treatment in an individual (n=27) or group format (n=27) ']",['Skin picking treatment with the Rothbaum cognitive behavioral therapy protocol'],"['SPD severity, anxiety, depression, clinical status and skin lesion severity', 'SPD symptom improvement', 'SPD, anxiety, and depression symptoms and objective patient lesion measures', 'SPD remission rates', 'SPD remission, comorbidities, and skin lesions']","[{'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1301627', 'cui_str': 'Format'}]","[{'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449440', 'cui_str': 'Clinical status'}, {'cui': 'C0037284', 'cui_str': 'Skin lesion'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1696701', 'cui_str': 'Dermatillomania'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}]",54.0,0.0387389,"The adapted Rothbaum protocol was effective for SPD remission, comorbidities, and skin lesions, both in individual and group formats.
","[{'ForeName': 'Alice C M', 'Initials': 'ACM', 'LastName': 'Xavier', 'Affiliation': 'Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, RS, Brazil.'}, {'ForeName': 'Camila M B', 'Initials': 'CMB', 'LastName': 'de Souza', 'Affiliation': 'Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, RS, Brazil.'}, {'ForeName': 'Luís H F', 'Initials': 'LHF', 'LastName': 'Flores', 'Affiliation': 'Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, RS, Brazil.'}, {'ForeName': 'Mariane B', 'Initials': 'MB', 'LastName': 'Bermudez', 'Affiliation': 'Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, RS, Brazil.'}, {'ForeName': 'Renata M F', 'Initials': 'RMF', 'LastName': 'Silva', 'Affiliation': 'Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, RS, Brazil.'}, {'ForeName': 'Ariadne C', 'Initials': 'AC', 'LastName': 'de Oliveira', 'Affiliation': 'Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, RS, Brazil.'}, {'ForeName': 'Carolina B', 'Initials': 'CB', 'LastName': 'Dreher', 'Affiliation': 'Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, RS, Brazil.'}]","Revista brasileira de psiquiatria (Sao Paulo, Brazil : 1999)",['10.1590/1516-4446-2019-0636']
536,32406009,The effect of TJ-28 (Eppikajutsuto) on the prevention of hand-foot syndrome using Capecitabine for colorectal cancer: The Yokohama Clinical Oncology Group Study (YCOG1102).,"BACKGROUND


Eppikajututo (TJ-28, a Kampo medicine) is effective against rheumatoid arthritis and eczema. We conducted a randomized comparative trial to assess the efficacy of TJ-28 for preventing hand-foot syndrome (HFS) as a complication of adjuvant chemotherapy using capecitabine.
METHODS


The present study was a multi-institutional randomized-controlled trial (UMIN000005899). Colorectal cancer patients scheduled to receive capecitabine chemotherapy as adjuvant therapy were randomly assigned to receive TJ-28 (7500 mg/day) or oral pyridoxine (60 mg/day). Patients were monitored for the development of grade ≥ 2 HFS according to the National Cancer Institute Common Toxicity Criteria until chemotherapy completion.
RESULTS


Twenty-two patients were enrolled in this study. The relative dose intensity of capecitabine was 76.2% in the TJ-28 group and 68.2% in the pyridoxine group. Grade ≥ 2 HFS developed in 6 (50.0%) of 12 TJ-28 patients and in 4 (40.0%) of 10 pyridoxine patients. Chemotherapy treatment failure was observed in seven patients, mainly due to HFS, liver dysfunction, diarrhea, and neutropenia. Chemotherapy treatment failure due to HFS occurred in none of the TJ-28 group and 2 patients (20.0%) in the pyridoxine group (p = 0.114).
CONCLUSION


Capecitabine-associated HFS was not markedly prevented by TJ-28 compared with pyridoxine. However, TJ-28 might support the continuation of chemotherapy with capecitabine. Further studies are warranted to clarify the benefits of TJ-28.",2020,The relative dose intensity of capecitabine was 76.2% in the TJ-28 group and 68.2% in the pyridoxine group.,"['colorectal cancer', 'Colorectal cancer patients scheduled to receive', 'Twenty-two patients were enrolled in this study']","['TJ-28 (Eppikajutsuto', 'Capecitabine', 'oral pyridoxine', 'TJ-28', 'capecitabine chemotherapy', 'capecitabine', 'pyridoxine']","['Chemotherapy treatment failure due to HFS', 'HFS, liver dysfunction, diarrhea, and neutropenia', 'Chemotherapy treatment failure', 'Grade ≥', 'HFS']","[{'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C4549708', 'cui_str': 'eppikajutsuto'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0034272', 'cui_str': 'pyridoxine'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0549410', 'cui_str': 'Palmar-plantar erythrodysaesthesia syndrome'}, {'cui': 'C0086565', 'cui_str': 'Abnormal liver function'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0441800', 'cui_str': 'Grade'}]",22.0,0.103454,The relative dose intensity of capecitabine was 76.2% in the TJ-28 group and 68.2% in the pyridoxine group.,"[{'ForeName': 'Kazuteru', 'Initials': 'K', 'LastName': 'Watanabe', 'Affiliation': 'Department of Gastroenterological Surgery, Yokohama City University, Yokohama, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Ishibe', 'Affiliation': 'Department of Gastroenterological Surgery, Yokohama City University, Yokohama, Japan. a.ishibe1225@gmail.com.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Watanabe', 'Affiliation': 'Department of Gastroenterological Center, Yokohama City University Medical center, Yokohama, Japan.'}, {'ForeName': 'Mitsuyoshi', 'Initials': 'M', 'LastName': 'Ota', 'Affiliation': 'Department of Gastroenterological Surgery, Yokohama City University, Yokohama, Japan.'}, {'ForeName': 'Shoichi', 'Initials': 'S', 'LastName': 'Fujii', 'Affiliation': 'Department of Surgery, Koga Hospital, Shizuoka, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Ichikawa', 'Affiliation': 'Department of Oncology, Yokohama City University , Yokohama, Japan.'}, {'ForeName': 'Mari S', 'Initials': 'MS', 'LastName': 'Oba', 'Affiliation': 'Department of Biostatics, Yokohama City University , Yokohama, Japan.'}, {'ForeName': 'Itaru', 'Initials': 'I', 'LastName': 'Endo', 'Affiliation': 'Department of Gastroenterological Surgery, Yokohama City University, Yokohama, Japan.'}]",Indian journal of gastroenterology : official journal of the Indian Society of Gastroenterology,['10.1007/s12664-020-01039-6']
537,32019154,Food Intervention with Folate Reduces TNF-α and Interleukin Levels in Overweight and Obese Women with the  MTHFR  C677T Polymorphism: A Randomized Trial.,"Methylenetetrahydrofolate reductase ( MTHFR ) C677T polymorphism associated with body fat accumulation could possibly trigger an inflammatory process by elevating homocysteine levels and increasing cytokine production, causing several diseases. This study aimed to evaluate the effects of food intervention, and not folate supplements, on the levels of tumor necrosis factor-α (TNF-α), interleukin-6 (IL-6), and interleukin-1β (IL-1β) in overweight and obese women with the  MTHFR  C677T polymorphism. A randomized, double-blind eight-week clinical trial of 48 overweight and obese women was conducted. Participants were randomly assigned into two groups. They received 300 g of vegetables daily for eight weeks containing different doses of folate: 95 µg/day for Group 1 and 191 µg/day for Group 2.  MTHFR  C677T polymorphism genotyping was assessed by digestion with HinfI enzyme and on 12% polyacrylamide gels. Anthropometric measurements, 24-h dietary recall, and biochemical analysis (blood folic acid, vitamin B12, homocysteine (Hcy), TNF-α, IL-1β, and IL-6) were determined at the beginning and end of the study. Group 2 had a significant increase in folate intake ( p  < 0.001) and plasma folic acid ( p  < 0.05) for individuals with the cytosine-cytosine (CC), cytosine-thymine (CT), and thymine-thymine (TT) genotypes. However, only individuals with the TT genotype presented reduced levels of Hcy, TNF-α, IL-6, and IL-1β ( p  < 0.001). Group 1 showed significant differences in folate consumption ( p  < 0.001) and folic acid levels ( p  < 0.05) for individuals with the CT and TT genotypes. Food intervention with folate from vegetables increased folic acid levels and reduced interleukins, TNF-α, and Hcy levels, mainly for individuals with the TT genotype.",2020,"Food intervention with folate from vegetables increased folic acid levels and reduced interleukins, TNF-α, and Hcy levels, mainly for individuals with the TT genotype.","['48 overweight and obese women', 'Overweight and Obese Women with the  MTHFR  C677T Polymorphism', 'overweight and obese women with the  MTHFR  C677T polymorphism']","['food intervention, and not folate supplements', 'cytosine-cytosine (CC), cytosine-thymine (CT']","['levels of Hcy, TNF-α, IL-6, and IL-1β', 'plasma folic acid', 'folate intake', 'levels of tumor necrosis factor-α (TNF-α), interleukin-6 (IL-6), and interleukin-1β (IL-1β', 'folic acid levels', 'folic acid levels and reduced interleukins, TNF-α, and Hcy levels', 'folate consumption', 'TNF-α and Interleukin Levels', 'Anthropometric measurements, 24-h dietary recall, and biochemical analysis (blood folic acid, vitamin B12, homocysteine (Hcy), TNF-α, IL-1β, and IL-6']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0032529', 'cui_str': 'Polymorphism (Genetics)'}]","[{'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C3661616', 'cui_str': 'Folate supplement'}, {'cui': 'C0010843', 'cui_str': 'Cytosine'}, {'cui': 'C0040087', 'cui_str': 'Thymine'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0564428', 'cui_str': 'Folate intake (observable entity)'}, {'cui': 'C0041368', 'cui_str': 'Tumor Necrosis Factors'}, {'cui': 'C0021764', 'cui_str': 'Interleukins'}, {'cui': 'C0427412', 'cui_str': 'Folic acid level - finding'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1328460', 'cui_str': 'Interleukin level'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0427417', 'cui_str': 'Blood folic acid'}, {'cui': 'C0042845', 'cui_str': 'cyanocobalamin'}, {'cui': 'C0019878', 'cui_str': '2-amino-4-mercaptobutyric acid'}]",48.0,0.163502,"Food intervention with folate from vegetables increased folic acid levels and reduced interleukins, TNF-α, and Hcy levels, mainly for individuals with the TT genotype.","[{'ForeName': 'Jéssica Vanessa de Carvalho', 'Initials': 'JVC', 'LastName': 'Lisboa', 'Affiliation': 'Postgraduate Program in Nutrition Sciences, Health Sciences Center, Federal University of Paraíba, João Pessoa 58059-900, Brazil.'}, {'ForeName': 'Marina Ramalho', 'Initials': 'MR', 'LastName': 'Ribeiro', 'Affiliation': 'Postgraduate Program in Nutrition Sciences, Health Sciences Center, Federal University of Paraíba, João Pessoa 58059-900, Brazil.'}, {'ForeName': 'Rafaella Cristhine Pordeus', 'Initials': 'RCP', 'LastName': 'Luna', 'Affiliation': 'Postgraduate Program in Nutrition Sciences, Health Sciences Center, Federal University of Paraíba, João Pessoa 58059-900, Brazil.'}, {'ForeName': 'Raquel Patrícia Ataíde', 'Initials': 'RPA', 'LastName': 'Lima', 'Affiliation': 'Postgraduate Program in Nutrition Sciences, Health Sciences Center, Federal University of Paraíba, João Pessoa 58059-900, Brazil.'}, {'ForeName': 'Rayner Anderson Ferreira do', 'Initials': 'RAFD', 'LastName': 'Nascimento', 'Affiliation': 'Postgraduate Program in Molecular and Human Biology, Center of Exact and Natural Sciences, Federal University of Paraíba, João Pessoa 58059-900, Brazil.'}, {'ForeName': 'Mussara Gomes Cavalcante Alves', 'Initials': 'MGCA', 'LastName': 'Monteiro', 'Affiliation': 'Postgraduate Program in Nutrition Sciences, Health Sciences Center, Federal University of Paraíba, João Pessoa 58059-900, Brazil.'}, {'ForeName': 'Keylha Querino de Farias', 'Initials': 'KQF', 'LastName': 'Lima', 'Affiliation': 'Postgraduate Program in Nutrition Sciences, Health Sciences Center, Federal University of Paraíba, João Pessoa 58059-900, Brazil.'}, {'ForeName': 'Carla Patrícia Novaes Dos Santos', 'Initials': 'CPNDS', 'LastName': 'Fechine', 'Affiliation': 'Postgraduate Program in Nutrition Sciences, Health Sciences Center, Federal University of Paraíba, João Pessoa 58059-900, Brazil.'}, {'ForeName': 'Naila Francis Paulo de', 'Initials': 'NFP', 'LastName': 'Oliveira', 'Affiliation': 'Departament of Molecular Biology, Federal University of Paraíba, João Pessoa 58059-900, Brazil.'}, {'ForeName': 'Darlene Camati', 'Initials': 'DC', 'LastName': 'Persuhn', 'Affiliation': 'Postgraduate Program in Nutrition Sciences, Health Sciences Center, Federal University of Paraíba, João Pessoa 58059-900, Brazil.'}, {'ForeName': 'Robson Cavalcante', 'Initials': 'RC', 'LastName': 'Veras', 'Affiliation': 'Postgraduate Program in Nutrition Sciences, Health Sciences Center, Federal University of Paraíba, João Pessoa 58059-900, Brazil.'}, {'ForeName': 'Maria da Conceição Rodrigues', 'Initials': 'MDCR', 'LastName': 'Gonçalves', 'Affiliation': 'Postgraduate Program in Nutrition Sciences, Health Sciences Center, Federal University of Paraíba, João Pessoa 58059-900, Brazil.'}, {'ForeName': 'Flávia Emília Leite de Lima', 'Initials': 'FELL', 'LastName': 'Ferreira', 'Affiliation': 'Postgraduate Program in Nutrition Sciences, Health Sciences Center, Federal University of Paraíba, João Pessoa 58059-900, Brazil.'}, {'ForeName': 'Roberto Teixeira', 'Initials': 'RT', 'LastName': 'Lima', 'Affiliation': 'Postgraduate Program in Nutrition Sciences, Health Sciences Center, Federal University of Paraíba, João Pessoa 58059-900, Brazil.'}, {'ForeName': 'Alexandre Sérgio da', 'Initials': 'ASD', 'LastName': 'Silva', 'Affiliation': 'Postgraduate Program in Nutrition Sciences, Health Sciences Center, Federal University of Paraíba, João Pessoa 58059-900, Brazil.'}, {'ForeName': 'Alcides da Silva', 'Initials': 'ADS', 'LastName': 'Diniz', 'Affiliation': 'Postgraduate Program in Nutrition Sciences, Federal University of Pernambuco, Recife 50670901, Brazil.'}, {'ForeName': 'Aléssio Tony Cavalcanti de', 'Initials': 'ATC', 'LastName': 'Almeida', 'Affiliation': 'Department of Economics, Postgraduate Program in App1lied Economics and Economics of the Public Sector, Center for Applied Social Sciences, Federal University of Paraíba, João Pessoa 58059-900, Brazil.'}, {'ForeName': 'Ronei Marcos de', 'Initials': 'RM', 'LastName': 'Moraes', 'Affiliation': 'Postgraduate Program in Health Decision Models, Federal University of Paraíba, João Pessoa 58059-900, Brazil.'}, {'ForeName': 'Eliseu Verly', 'Initials': 'EV', 'LastName': 'Junior', 'Affiliation': 'Department of Epidemiology, Institute of Social Medicine, State University of Rio de Janeiro, Rio de Janeiro 20550-900, Brazil.'}, {'ForeName': 'Maria José de Carvalho', 'Initials': 'MJC', 'LastName': 'Costa', 'Affiliation': 'Postgraduate Program in Nutrition Sciences, Health Sciences Center, Federal University of Paraíba, João Pessoa 58059-900, Brazil.'}]",Nutrients,['10.3390/nu12020361']
538,32057811,Randomized Trial of 2 Endoscopic Radial Artery Harvesting Devices-Immunofluorescence Assessment.,"BACKGROUND


Various devices are available for endoscopic radial artery harvesting during coronary artery bypass grafting. Thermal spread and graft damage, however, are common concerns. The aim of this study was to compare the MiFusion TLS2 system (Endotrust, Nettetal Germany) with direct heat technique and the LigaSure Maryland system (Medtronic, Dublin, Ireland) using advanced bipolar technique in a prospective randomized study.
METHODS


One hundred consecutive patients undergoing coronary artery bypass grafting with endoscopic radial artery harvesting were prospectively included and randomized 1:1. The proximal (brachial) ends of the grafts were analyzed using fluorescence microscopy with focus on graft integrity. In addition, harvesting time, graft sealing, residual bleeding, and incidence of neurological disorders were compared.
RESULTS


Patient age was 67 ± 8 years. Mean harvesting time was 26.5 ± 9 minutes for the TLS2 and 23.2 ± 8 minutes for the LigaSure (P = .049). Overall graft integrity was good in both groups. A significantly better graft integrity was observed in the LigaSure group (scale 0 to 3; 3 = best) with 2.5 ± 0.6 for TLS2 and 2.8 ± 0.4 for LigaSure (P = .031). LigaSure provided significantly better graft sealing (scale 0 to 2; 0 = best) with 0.6 ± 0.7 vs 1.0 ± 0.6 (TLS2) (P = .006) and less residual bleeding (scale 1 to 5; 1 = best) with 1.4 ± 0.6 vs 2.0 ± 0.9 (TLS2) (P < .001). Transient sensibility disorders were less frequently observed with LigaSure (2% vs 16%, P = .015).
CONCLUSIONS


Endoscopic radial artery harvesting can be performed with excellent results and good graft integrity using both devices. Compared with the MiFusion TLS2, the LigaSure device led to faster procedural times and resulted in better graft integrity. Along with providing a better seal, LigaSure was associated with less sensibility disorders.",2020,A significantly better graft integrity was observed in the LigaSure group (scale 0 to 3; 3=best) with 2.5±0.6 for TLS2™ and 2.8±0.4 for LigaSure (p=0.031).,"['Patient age was 67±8 years', '100 consecutive patients undergoing CABG with ERAH']","['MiFusion TLS2', 'MiFusion TLS2™ system (Endotrust, Germany) with direct heat technique and the LigaSure™ Maryland system (Medtronic, USA', 'endoscopic radial artery harvesting (ERAH', 'endoscopic radial artery harvesting devices - immunofluorescence assessment', 'coronary artery bypass grafting (CABG']","['Overall graft integrity', 'graft sealing', 'harvesting time, graft sealing, residual bleeding and incidence of neurological disorders', 'Mean harvesting time', 'Transient sensibility disorders', 'graft integrity', 'residual bleeding', 'sensibility disorders']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}]","[{'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0024858', 'cui_str': 'Maryland'}, {'cui': 'C0162857', 'cui_str': 'Radial Artery'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0079603', 'cui_str': 'Immunofluorescence'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C1947912', 'cui_str': 'Integrity (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0027765', 'cui_str': 'Neurologic Disorders'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C0439823', 'cui_str': 'Sensibilities (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",100.0,0.0361679,A significantly better graft integrity was observed in the LigaSure group (scale 0 to 3; 3=best) with 2.5±0.6 for TLS2™ and 2.8±0.4 for LigaSure (p=0.031).,"[{'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Van Linden', 'Affiliation': 'Department of Cardiothoracic and Vascular Surgery, Goethe University Hospital Frankfurt, Frankfurt. Electronic address: arnaud.vanlinden@kgu.de.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Hecker', 'Affiliation': 'Department of Cardiothoracic and Vascular Surgery, Goethe University Hospital Frankfurt, Frankfurt.'}, {'ForeName': 'Jasper', 'Initials': 'J', 'LastName': 'Lehmann-Grube', 'Affiliation': 'Medical School, Justus Liebig University Giessen, Giessen.'}, {'ForeName': 'Mani', 'Initials': 'M', 'LastName': 'Arsalan', 'Affiliation': 'Department of Cardiothoracic and Vascular Surgery, Goethe University Hospital Frankfurt, Frankfurt.'}, {'ForeName': 'Manfred', 'Initials': 'M', 'LastName': 'Richter', 'Affiliation': 'Department of Cardiac Surgery, Kerckhoff Clinic, Bad Nauheim, Germany.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Matzke', 'Affiliation': 'Max-Planck-Institute for Heart and Lung Research, Bad Nauheim, Germany.'}, {'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Holubec', 'Affiliation': 'Department of Cardiothoracic and Vascular Surgery, Goethe University Hospital Frankfurt, Frankfurt.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Walther', 'Affiliation': 'Department of Cardiothoracic and Vascular Surgery, Goethe University Hospital Frankfurt, Frankfurt.'}]",The Annals of thoracic surgery,['10.1016/j.athoracsur.2019.12.063']
539,32193786,Evaluation of Adenoid Hypertrophy with Ultrasonography.,"OBJECTIVES


To determine the reliability of ultrasound in the diagnosis of adenoid hypertrophy in children.
METHODS


The subjects were divided into three groups: Group A: Pre-experiment group: 30 children who were hospitalized for adenoidal hypertrophy were selected, and preoperative ultrasound was used to measure adenoid thickness. Their re-confirmed Adenoid ultrasound measurement thickness was obtained during surgery under the guidance of metal instruments; Group B: Ultrasound screening group: 1898 children aged 3-12 y were selected, and their adenoids were examined by ultrasonography to observe the size, shape, echo and blood flow of adenoids and the thickness of adenoids; Group C: Surgical resection group: 133 hospitalized patients were selected, and their adenoid ultrasound measurement thickness (AUT), the adenoid-nasopharynx (A/N) ratio was calculated based on nasopharyngeal lateral radiographs and obstruction ratio was obtained in electronic nasopharyngoscopy [extent of adenoid-posterior nostril occlusion (EANC)] were compared.
RESULTS


In Group A, there was no statistical difference in the measurements of the adenoids between the preoperative ultrasound and the ultrasound measurements under the guidance of intraoperative metal instruments (P > 0.05). In Group B, the adenoids of 1898 children aged 3-12 y were measured and were found thickest at 6 y, with an average of 5.035 ± 0.0609 mm. There was no statistical difference in adenoid thickness between boys and girls (P > 0.05). In Group C, there was a linear correlation between AUT and A/N ratio (r = 0.999, P = 0.01) and between AUT and EANC (r = 0.950, P = 0.000).
CONCLUSIONS


In children between 3 and 12 y of age, AUT greater than 6 mm may be considered for surgical resection of adenoid hypertrophy.",2020,"In Group A, there was no statistical difference in the measurements of the adenoids between the preoperative ultrasound and the ultrasound measurements under the guidance of intraoperative metal instruments (P > 0.05).","['1898 children aged 3-12 y', 'group: 30 children who were hospitalized for adenoidal hypertrophy', 'children', 'group: 1898 children aged 3-12 y were selected, and their adenoids were examined by ultrasonography to observe the size, shape, echo and blood flow of adenoids and the thickness of adenoids; Group C: Surgical resection group: 133 hospitalized patients']","['Pre-experiment', 'Ultrasound screening', 'Ultrasonography', 'adenoid ultrasound measurement thickness (AUT), the adenoid-nasopharynx (A/N) ratio was calculated based on nasopharyngeal lateral radiographs and obstruction ratio was obtained in electronic nasopharyngoscopy [extent of adenoid-posterior nostril occlusion (EANC']","['adenoid thickness', 'surgical resection of adenoid hypertrophy']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0149825', 'cui_str': 'Hypertrophy of adenoids (disorder)'}, {'cui': 'C0522512', 'cui_str': 'With shape (attribute)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C0441837', 'cui_str': 'Group C (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0041618', 'cui_str': 'Echotomography'}, {'cui': 'C0001428', 'cui_str': 'Pharyngeal Tonsils'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0027442', 'cui_str': 'Rhinopharynx'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0444686', 'cui_str': 'Calculated (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C1306645', 'cui_str': 'Plain x-ray'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0189025', 'cui_str': 'Nasopharyngoscopy (procedure)'}, {'cui': 'C0439792', 'cui_str': 'Extents (qualifier value)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0595944', 'cui_str': 'Structure of anterior naris'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}]","[{'cui': 'C0001428', 'cui_str': 'Pharyngeal Tonsils'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0020564', 'cui_str': 'Hypertrophy'}]",1898.0,0.0180158,"In Group A, there was no statistical difference in the measurements of the adenoids between the preoperative ultrasound and the ultrasound measurements under the guidance of intraoperative metal instruments (P > 0.05).","[{'ForeName': 'Yanjuan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Ultrasound, The General Hospital of Ningxia Medical University, Yinchuan, 750004, Ningxia, China. yjwang1@yandex.ru.'}, {'ForeName': 'Huajie', 'Initials': 'H', 'LastName': 'Jiao', 'Affiliation': 'Department of Ultrasound, The General Hospital of Ningxia Medical University, Yinchuan, 750004, Ningxia, China.'}, {'ForeName': 'Chengrong', 'Initials': 'C', 'LastName': 'Mi', 'Affiliation': 'Department of Ultrasound, The General Hospital of Ningxia Medical University, Yinchuan, 750004, Ningxia, China.'}, {'ForeName': 'Guangfei', 'Initials': 'G', 'LastName': 'Yang', 'Affiliation': 'Department of Ultrasound, The General Hospital of Ningxia Medical University, Yinchuan, 750004, Ningxia, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Han', 'Affiliation': 'Department of Ultrasound, The General Hospital of Ningxia Medical University, Yinchuan, 750004, Ningxia, China.'}]",Indian journal of pediatrics,['10.1007/s12098-020-03203-4']
540,32130136,Effectiveness and Parental Acceptability of Social Networking Interventions for Promoting Seasonal Influenza Vaccination Among Young Children: Randomized Controlled Trial.,"BACKGROUND


Seasonal influenza vaccination (SIV) coverage among young children remains low worldwide. Mobile social networking apps such as WhatsApp Messenger are promising tools for health interventions.
OBJECTIVE


This was a preliminary study to test the effectiveness and parental acceptability of a social networking intervention that sends weekly vaccination reminders and encourages exchange of SIV-related views and experiences among mothers via WhatsApp discussion groups for promoting childhood SIV. The second objective was to examine the effect of introducing time pressure on mothers' decision making for childhood SIV for vaccination decision making. This was done using countdowns of the recommended vaccination timing.
METHODS


Mothers of child(ren) aged 6 to 72 months were randomly allocated to control or to one of two social networking intervention groups receiving vaccination reminders with (SNI+TP) or without (SNI-TP) a time pressure component via WhatsApp discussion groups at a ratio of 5:2:2. All participants first completed a baseline assessment. Both the SNI-TP and SNI+TP groups subsequently received weekly vaccination reminders from October to December 2017 and participated in WhatsApp discussions about SIV moderated by a health professional. All participants completed a follow-up assessment from April to May 2018.
RESULTS


A total of 84.9% (174/205), 71% (57/80), and 75% (60/80) who were allocated to the control, SNI-TP, and SNI+TP groups, respectively, completed the outcome assessment. The social networking intervention significantly promoted mothers' self-efficacy for taking children for SIV (SNI-TP: odds ratio [OR] 2.69 [1.07-6.79]; SNI+TP: OR 2.50 [1.13-5.55]), but did not result in significantly improved children's SIV uptake. Moreover, after adjusting for mothers' working status, introducing additional time pressure reduced the overall SIV uptake in children of working mothers (OR 0.27 [0.10-0.77]) but significantly increased the SIV uptake among children of mothers without a full-time job (OR 6.53 [1.87-22.82]). Most participants' WhatsApp posts were about sharing experience or views (226/434, 52.1%) of which 44.7% (101/226) were categorized as negative, such as their concerns over vaccine safety, side effects and effectiveness. Although participants shared predominantly negative experience or views about SIV at the beginning of the discussion, the moderator was able to encourage the discussion of more positive experience or views and more knowledge and information. Most intervention group participants indicated willingness to receive the same interventions (110/117, 94.0%) and recommend the interventions to other mothers (102/117, 87.2%) in future.
CONCLUSIONS


Online information support can effectively promote mothers' self-efficacy for taking children for SIV but alone it may not sufficient to address maternal concerns over SIV to achieve a positive vaccination decision. However, the active involvement of health professionals in online discussions can shape positive discussions about vaccination. Time pressure on decision making interacts with maternal work status, facilitating vaccination uptake among mothers who may have more free time, but having the opposite effect among busier working mothers.
TRIAL REGISTRATION


Hong Kong University Clinical Trials Registry HKUCTR-2250; https://tinyurl.com/vejv276.",2020,This was a preliminary study to test the effectiveness and parental acceptability of a social networking intervention that sends weekly vaccination reminders and encourages exchange of SIV-related views and experiences among mothers via WhatsApp discussion groups for promoting childhood SIV.,"['Mothers of child(ren) aged 6 to 72 months', 'young children', 'Young Children', 'mothers via WhatsApp discussion groups for promoting childhood SIV']","['social networking intervention groups receiving vaccination reminders with (SNI+TP) or without (SNI-TP) a time pressure component via WhatsApp discussion', 'social networking intervention', 'Social Networking Interventions', 'HKUCTR-2250']","['SIV uptake', 'effectiveness and parental acceptability', ""mothers' self-efficacy"", ""children's SIV uptake"", 'overall SIV uptake', 'Seasonal Influenza Vaccination']","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0557061', 'cui_str': 'Discussion (procedure)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}]","[{'cui': 'C3179002', 'cui_str': 'Social Networking'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0557061', 'cui_str': 'Discussion (procedure)'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439601', 'cui_str': 'Seasonal course (qualifier value)'}, {'cui': 'C0042200', 'cui_str': 'Influenza vaccination (procedure)'}]",,0.0702659,This was a preliminary study to test the effectiveness and parental acceptability of a social networking intervention that sends weekly vaccination reminders and encourages exchange of SIV-related views and experiences among mothers via WhatsApp discussion groups for promoting childhood SIV.,"[{'ForeName': 'Qiuyan', 'Initials': 'Q', 'LastName': 'Liao', 'Affiliation': 'University of Hong Kong, Hong Kong, China (Hong Kong).'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Fielding', 'Affiliation': 'University of Hong Kong, Hong Kong, China (Hong Kong).'}, {'ForeName': 'Yee Tak Derek', 'Initials': 'YTD', 'LastName': 'Cheung', 'Affiliation': 'University of Hong Kong, Hong Kong, China (Hong Kong).'}, {'ForeName': 'Jinxiao', 'Initials': 'J', 'LastName': 'Lian', 'Affiliation': 'The Hong Kong Polytechnic University, Hong Kong, China (Hong Kong).'}, {'ForeName': 'Jiehu', 'Initials': 'J', 'LastName': 'Yuan', 'Affiliation': 'University of Hong Kong, Hong Kong, China (Hong Kong).'}, {'ForeName': 'Wendy Wing Tak', 'Initials': 'WWT', 'LastName': 'Lam', 'Affiliation': 'University of Hong Kong, Hong Kong, China (Hong Kong).'}]",Journal of medical Internet research,['10.2196/16427']
541,31650217,18 F-FDG PET-MR enterography in predicting histological active disease using the Nancy index in ulcerative colitis: a randomized controlled trial.,"PURPOSE


To evaluate the diagnostic performance of PET-MR enterography in detecting histological active inflammation in patients with ulcerative colitis and the impact of bowel purgation on diagnostic accuracies of PET-MR parameters.
METHODS


Fifty patients were enrolled in this randomized controlled trial (clinicaltrials.gov [NCT03781284]). Forty patients were randomized in two study arms, in which bowel purgation was performed either before or after PET-MR enterography. All patients underwent ileocolonoscopy with mucosal biopsies after PET-MR within 24 h. Diagnostic performance of MR morphological parameters (MRmorph), diffusion-weighted imaging (DWI), and PET in detecting histological inflammation determined by the Nancy index was compared with each other and between study arms. Correlation between PET and histological inflammatory severity was calculated.
RESULTS


In study arm without previous bowel purgation, SUV max  ratio of bowel segment (relative to SUV max  of the liver) facilitated the highest specificity and diagnostic accuracy compared with MRmorph and DWI. Bowel cleansing led to markedly increased metabolic activity of bowel segments, resulting in significantly reduced specificity of PET compared with study arm without purgation (0.808 vs. 0.966, p = 0.007, respectively). Inter-observer concordance for assessing MRmorph was clearly increased after bowel cleansing (Cohen's κ, 0.847 vs. 0.665; p = 0.013, respectively), though diagnostic performance of MRmorph was not significantly improved. Our findings suggested that the change of metabolic status was mainly associated with the grade of neutrophil infiltrate and less dependent on chronic infiltrate.
CONCLUSION


PET-MR enterography was an excellent non-invasive diagnostic method in the assessment of histological active inflammation in ulcerative colitis without the need of previous bowel purgation.
TRIAL REGISTRATION


https://clinicaltrials.gov/ct2/show/NCT03781284.",2020,"PET-MR enterography was an excellent non-invasive diagnostic method in the assessment of histological active inflammation in ulcerative colitis without the need of previous bowel purgation.
","['Forty patients', 'patients with ulcerative colitis', 'ulcerative colitis', 'Fifty patients']","['PET-MR enterography', 'ileocolonoscopy', '18 F-FDG PET-MR enterography']","['specificity of PET', 'diagnostic performance of MRmorph', 'Diagnostic performance of MR morphological parameters (MRmorph), diffusion-weighted imaging (DWI), and PET in detecting histological inflammation', 'metabolic activity of bowel segments']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009324', 'cui_str': 'Inflammatory Bowel Disease, Ulcerative Colitis Type'}]","[{'cui': 'C0031268', 'cui_str': 'Companion Animals'}, {'cui': 'C0302995', 'cui_str': '18F radioisotope'}]","[{'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C0205462', 'cui_str': 'Histologic (qualifier value)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0441635', 'cui_str': 'Segment (qualifier value)'}]",50.0,0.370516,"PET-MR enterography was an excellent non-invasive diagnostic method in the assessment of histological active inflammation in ulcerative colitis without the need of previous bowel purgation.
","[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Diagnostic and Interventional Radiology and Neuroradiology, University Hospital Essen, University of Duisburg-Essen, Hufelandstrasse 55, 45147, Essen, Germany. yan.li@uk-essen.de.'}, {'ForeName': 'Benedikt', 'Initials': 'B', 'LastName': 'Schaarschmidt', 'Affiliation': 'Department of Diagnostic and Interventional Radiology and Neuroradiology, University Hospital Essen, University of Duisburg-Essen, Hufelandstrasse 55, 45147, Essen, Germany.'}, {'ForeName': 'Lale', 'Initials': 'L', 'LastName': 'Umutlu', 'Affiliation': 'Department of Diagnostic and Interventional Radiology and Neuroradiology, University Hospital Essen, University of Duisburg-Essen, Hufelandstrasse 55, 45147, Essen, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Forsting', 'Affiliation': 'Department of Diagnostic and Interventional Radiology and Neuroradiology, University Hospital Essen, University of Duisburg-Essen, Hufelandstrasse 55, 45147, Essen, Germany.'}, {'ForeName': 'Aydin', 'Initials': 'A', 'LastName': 'Demircioglu', 'Affiliation': 'Department of Diagnostic and Interventional Radiology and Neuroradiology, University Hospital Essen, University of Duisburg-Essen, Hufelandstrasse 55, 45147, Essen, Germany.'}, {'ForeName': 'Anna Katharina', 'Initials': 'AK', 'LastName': 'Koch', 'Affiliation': 'Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, University of Duisburg-Essen, Am Deimelsberg 34a, 45276, Essen, Germany.'}, {'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'Martin', 'Affiliation': 'Department of Diagnostic and Interventional Radiology, University Hospital Dusseldorf, Moorenstraße 5, 40225, Düsseldorf, Germany.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Herrmann', 'Affiliation': 'Department of Nuclear Medicine, University Hospital Essen, University of Duisburg-Essen, Hufelandstrasse 55, 45147, Essen, Germany.'}, {'ForeName': 'Hendrik', 'Initials': 'H', 'LastName': 'Juette', 'Affiliation': 'Department of Pathology, Ruhr-Universität Hospital Bochum, Bürkle-de-la-Camp-Platz 1, 44789, Bochum, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Tannapfel', 'Affiliation': 'Department of Pathology, Ruhr-Universität Hospital Bochum, Bürkle-de-la-Camp-Platz 1, 44789, Bochum, Germany.'}, {'ForeName': 'Jost', 'Initials': 'J', 'LastName': 'Langhorst', 'Affiliation': 'Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, University of Duisburg-Essen, Am Deimelsberg 34a, 45276, Essen, Germany.'}]",European journal of nuclear medicine and molecular imaging,['10.1007/s00259-019-04535-w']
542,31385912,Acute Exercise Effects Predict Training Change in Cognition and Connectivity.,"PURPOSE


Previous studies report memory and functional connectivity of memory systems improve acutely after a single aerobic exercise session or with training, suggesting that the acute effects of aerobic exercise may reflect initial changes that adapt over time. In this trial, for the first time, we test the proof-of-concept of whether the acute and training effects of aerobic exercise on working memory and brain network connectivity are related in the same participants.
METHODS


Cognitively normal older participants (N = 34) were enrolled in a randomized clinical trial (NCT02453178). Participants completed fMRI resting state and a face working memory N-back task acutely after light- and moderate-intensity exercises and after a 12-wk aerobic training intervention.
RESULTS


Functional connectivity did not change more after moderate-intensity training compared with light-intensity training. However, both training groups showed similar changes in cardiorespiratory fitness (CRF) (maximal exercise oxygen uptake, V˙O2peak), limiting group-level comparisons. Acute effects of moderate-intensity aerobic exercise on connections primarily in the default network predicted training enhancements in the same connections. Working memory also improved acutely, especially after moderate-intensity, and greater acute improvements predicted greater working memory improvement with training. Exercise effects on functional connectivity of right lateralized frontoparietal connections were related to both acute and training gains in working memory.
CONCLUSIONS


Our data support the concept of acute aerobic exercise effects on functional brain systems and performance as an activity-evoked biomarker for exercise training benefits in the same outcomes. These findings may lead to new insights and methods for improving memory outcomes with aerobic exercise training.",2020,"Exercise effects on functional connectivity of right lateralized fronto-parietal connections were related to both acute and training gains in working memory.
","['Cognitively normal older participants (N=34', 'same participants']","['aerobic exercise', 'fMRI resting state and a face working memory N-back task acutely after light and moderate intensity exercise and after a 12-week aerobic training intervention', 'moderate intensity aerobic exercise', 'aerobic exercise training']","['hippocampal-cortical connections', 'cardiorespiratory fitness (maximal exercise oxygen uptake, VO2peak', 'working memory and brain network connectivity', 'functional connectivity of right lateralized fronto-parietal connections', 'Cognition and Connectivity']","[{'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0449379', 'cui_str': 'Connection (attribute)'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake (observable entity)'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0442030', 'cui_str': 'Parietal (qualifier value)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",,0.0718148,"Exercise effects on functional connectivity of right lateralized fronto-parietal connections were related to both acute and training gains in working memory.
","[{'ForeName': 'Michelle W', 'Initials': 'MW', 'LastName': 'Voss', 'Affiliation': 'Department of Psychological and Brain Sciences, University of Iowa, Iowa City, IA.'}, {'ForeName': 'Timothy B', 'Initials': 'TB', 'LastName': 'Weng', 'Affiliation': 'Department of Psychological and Brain Sciences, University of Iowa, Iowa City, IA.'}, {'ForeName': 'Krithika', 'Initials': 'K', 'LastName': 'Narayana-Kumanan', 'Affiliation': 'Department of Psychiatry, Carver College of Medicine, University of Iowa, Iowa City, IA.'}, {'ForeName': 'Rachel C', 'Initials': 'RC', 'LastName': 'Cole', 'Affiliation': 'Interdisciplinary Graduate Program in Neuroscience, University of Iowa, Iowa City, IA.'}, {'ForeName': 'Conner', 'Initials': 'C', 'LastName': 'Wharff', 'Affiliation': 'Department of Psychological and Brain Sciences, University of Iowa, Iowa City, IA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Reist', 'Affiliation': 'Department of Psychological and Brain Sciences, University of Iowa, Iowa City, IA.'}, {'ForeName': 'Lyndsey', 'Initials': 'L', 'LastName': 'Dubose', 'Affiliation': 'Department of Health and Human Physiology, University of Iowa, Iowa City, IA.'}, {'ForeName': 'Gardar', 'Initials': 'G', 'LastName': 'Sigurdsson', 'Affiliation': 'Department of Internal Medicine, University of Iowa, Iowa City, IA.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Mills', 'Affiliation': 'Department of Psychiatry, Carver College of Medicine, University of Iowa, Iowa City, IA.'}, {'ForeName': 'Jeffrey D', 'Initials': 'JD', 'LastName': 'Long', 'Affiliation': 'Department of Psychiatry, Carver College of Medicine, University of Iowa, Iowa City, IA.'}, {'ForeName': 'Vincent A', 'Initials': 'VA', 'LastName': 'Magnotta', 'Affiliation': 'Department of Radiology, University of Iowa, Iowa City, IA.'}, {'ForeName': 'Gary L', 'Initials': 'GL', 'LastName': 'Pierce', 'Affiliation': 'Department of Health and Human Physiology, University of Iowa, Iowa City, IA.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002115']
543,31647496,Five-Year Cost-effectiveness of Intravitreous Ranibizumab Therapy vs Panretinal Photocoagulation for Treating Proliferative Diabetic Retinopathy: A Secondary Analysis of a Randomized Clinical Trial.,"Importance


The DRCR Retina Network Protocol S randomized clinical trial suggested that the mean visual acuity of eyes with proliferative diabetic retinopathy (PDR) treated with ranibizumab is not worse at 5 years than that of eyes treated with panretinal photocoagulation (PRP). Moreover, the ranibizumab group had fewer new cases of diabetic macular edema (DME) with vision loss or vitrectomy but had 4 times the number of injections and 3 times the number of visits. Although 2-year cost-effectiveness results of Protocol S were previously identified, incorporating 5-year data from Protocol S could alter the longer-term cost-effectiveness of the treatment strategies from the perspective of the health care system.
Objective


To evaluate 5- and 10-year cost-effectiveness of therapy with ranibizumab, 0.5 mg, compared with PRP for treating PDR.
Design, Setting, and Participants


A preplanned secondary analysis of the Protocol S randomized clinical trial using efficacy, safety, and resource utilization data through 5 years of follow-up for 213 adults diagnosed with PDR and simulating results through 10 years.
Interventions


Intravitreous ranibizumab, 0.5 mg, at baseline and as frequently as every 4 weeks based on a structured retreatment protocol vs PRP at baseline for PDR; eyes in both groups could receive ranibizumab for concomitant DME with vision loss.
Main Outcomes and Measures


Incremental cost-effectiveness ratios (ICERs) of ranibizumab therapy compared with PRP were evaluated for those with and without center-involved DME (CI-DME) and vision loss (Snellen equivalent, 20/32 or worse) at baseline.
Results


The study included 213 adults with a mean (SD) age of 53 (12) years, of whom 92 (43%) were women and 155 (73%) were white. The ICER of the ranibizumab group compared with PRP for patients without CI-DME at baseline was $582 268 per quality-adjusted life-year (QALY) at 5 years and $742 202/QALY at 10 years. For patients with baseline CI-DME, ICERs were $65 576/QALY at 5 years and $63 930/QALY at 10 years.
Conclusions and Relevance


This study suggests that during 5 to 10 years of treatment, ranibizumab, 0.5 mg, as given in the studied trial compared with PRP may be within the frequently cited range considered cost-effective in the United States for eyes presenting with PDR and vision-impairing CI-DME, but not for those with PDR but without vision-impairing CI-DME. Substantial reductions in anti-vascular endothelial growth factor cost may make the ranibizumab therapy cost-effective within this range even for patients without baseline CI-DME.
Trial Registration


ClinicalTrials.gov identifier: NCT01489189.",2019,"For patients with baseline CI-DME, ICERs were $65 576/QALY at 5 years and $63 930/QALY at 10 years.
","['eyes with proliferative diabetic retinopathy (PDR', 'Proliferative Diabetic Retinopathy', '213 adults diagnosed with PDR and simulating results through 10 years', '213 adults with a mean (SD) age of 53 (12) years, of whom 92 (43%) were women and 155 (73%) were white']","['ranibizumab', 'Intravitreous Ranibizumab Therapy vs Panretinal Photocoagulation', 'panretinal photocoagulation (PRP', 'Intravitreous ranibizumab', 'PRP']","['diabetic macular edema (DME) with vision loss or vitrectomy', 'DME (CI-DME) and vision loss', 'Measures\n\n\nIncremental cost-effectiveness ratios (ICERs', '5- and 10-year cost-effectiveness']","[{'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0154830', 'cui_str': 'PDR - proliferative diabetic retinopathy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0043157', 'cui_str': 'Whites'}]","[{'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0730064', 'cui_str': 'Scatter retinal laser photocoagulation'}, {'cui': 'C0242848', 'cui_str': 'PrP (GSS)'}]","[{'cui': 'C0730285', 'cui_str': 'Diabetic macular edema'}, {'cui': 'C3665346', 'cui_str': 'Unspecified visual loss'}, {'cui': 'C0042903', 'cui_str': 'Vitrectomy'}, {'cui': 'C0641456', 'cui_str': 'DMES'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",213.0,0.32027,"For patients with baseline CI-DME, ICERs were $65 576/QALY at 5 years and $63 930/QALY at 10 years.
","[{'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Hutton', 'Affiliation': 'Department of Health Management and Policy, University of Michigan School of Public Health, Ann Arbor.'}, {'ForeName': 'Joshua D', 'Initials': 'JD', 'LastName': 'Stein', 'Affiliation': 'Department of Health Management and Policy, University of Michigan School of Public Health, Ann Arbor.'}, {'ForeName': 'Adam R', 'Initials': 'AR', 'LastName': 'Glassman', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'Neil M', 'Initials': 'NM', 'LastName': 'Bressler', 'Affiliation': 'Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Lee M', 'Initials': 'LM', 'LastName': 'Jampol', 'Affiliation': 'Feinberg School of Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Jennifer K', 'Initials': 'JK', 'LastName': 'Sun', 'Affiliation': 'Beetham Eye Institute, Joslin Diabetes Center, Boston, Massachusetts.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA ophthalmology,['10.1001/jamaophthalmol.2019.4284']
544,31884854,"Effects of Interleukin-1β Inhibition on Blood Pressure, Incident Hypertension, and Residual Inflammatory Risk: A Secondary Analysis of CANTOS.","While hypertension and inflammation are physiologically inter-related, the effect of therapies that specifically target inflammation on blood pressure is uncertain. The recent CANTOS (Canakinumab Anti-inflammatory Thrombosis Outcomes Study) afforded the opportunity to test whether IL (interleukin)-1β inhibition would reduce blood pressure, prevent incident hypertension, and modify relationships between hypertension and cardiovascular events. CANTOS randomized 10 061 patients with prior myocardial infarction and hsCRP (high sensitivity C-reactive protein) ≥2 mg/L to canakinumab 50 mg, 150 mg, 300 mg, or placebo. A total of 9549 trial participants had blood pressure recordings during follow-up; of these, 80% had a preexisting diagnosis of hypertension. In patients without baseline hypertension, rates of incident hypertension were 23.4, 26.6, and 28.1 per 100-person years for the lowest to highest baseline tertiles of hsCRP ( P >0.2). In all participants random allocation to canakinumab did not reduce blood pressure ( P >0.2) or incident hypertension during the follow-up period (hazard ratio, 0.96 [0.85-1.08],  P >0.2). IL-1β inhibition with canakinumab reduces major adverse cardiovascular event rates. These analyses suggest that the mechanisms underlying this benefit are not related to changes in blood pressure or incident hypertension. Clinical Trial Registration- URL: https://clinicaltrials.gov. Unique identifier: NCT01327846.",2020,"In all participants random allocation to canakinumab did not reduce blood pressure ( P >0.2) or incident hypertension during the follow-up period (hazard ratio, 0.96 [0.85-1.08],  P >0.2).","['061 patients with prior myocardial infarction and hsCRP (high sensitivity C-reactive protein) ≥2 mg', 'A total of 9549 trial participants had blood pressure recordings during follow-up; of these, 80% had a preexisting diagnosis of hypertension']","['L to canakinumab 50 mg, 150 mg, 300 mg, or placebo', 'Interleukin-1β Inhibition', 'IL (interleukin)-1β inhibition']","['Blood Pressure, Incident Hypertension, and Residual Inflammatory Risk', 'blood pressure or incident hypertension', 'rates of incident hypertension', 'incident hypertension', 'blood pressure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}]","[{'cui': 'C2718773', 'cui_str': 'canakinumab'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0021764', 'cui_str': 'Interleukins'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",,0.224736,"In all participants random allocation to canakinumab did not reduce blood pressure ( P >0.2) or incident hypertension during the follow-up period (hazard ratio, 0.96 [0.85-1.08],  P >0.2).","[{'ForeName': 'Alexander Mk', 'Initials': 'AM', 'LastName': 'Rothman', 'Affiliation': 'From the Department of Cardiology, Chesterman Cardiothoracic Unit, Northern General Hospital, Sheffield, United Kingdom (A.M.K.R.).'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'MacFadyen', 'Affiliation': ""Center for Cardiovascular Disease Prevention (J.M., R.J.G., P.M.R.), Brigham and Women's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Thuren', 'Affiliation': 'Novartis Pharmaceutical Corporation, One Health Plaza, East Hanover, NJ (T.T.).'}, {'ForeName': 'Alastair', 'Initials': 'A', 'LastName': 'Webb', 'Affiliation': 'Centre for Prevention of Stroke and Dementia, Department of Clinical Neurosciences, University of Oxford, United Kingdom (A.W.).'}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Harrison', 'Affiliation': 'Vanderbilt University, Nashville, TN (D.G.H.).'}, {'ForeName': 'Tomasz J', 'Initials': 'TJ', 'LastName': 'Guzik', 'Affiliation': 'Institute of Cardiovascular and Medical Research, Queen Elizabeth University Hospital, University of Glasgow (T.J.G.).'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Libby', 'Affiliation': ""Cardiovascular Division (P.L.), Brigham and Women's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Glynn', 'Affiliation': ""Center for Cardiovascular Disease Prevention (J.M., R.J.G., P.M.R.), Brigham and Women's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Ridker', 'Affiliation': ""Center for Cardiovascular Disease Prevention (J.M., R.J.G., P.M.R.), Brigham and Women's Hospital, Harvard Medical School, Boston, MA.""}]","Hypertension (Dallas, Tex. : 1979)",['10.1161/HYPERTENSIONAHA.119.13642']
545,31578055,Evaluation of the effect of aroma oil as a bath salt on cognitive function.,"BACKGROUND


Aromatherapy is a non-pharmacological therapy for the improvement of dementia symptoms. This study aimed to assess the effects of aroma oil as a bath salt on cognitive function, olfactory function and sleep quality.
METHODS


This was a randomised controlled trial. Overall, 49 patients were able to provide consent, and 35 were finally analysed (Alzheimer's disease: 10, mild cognitive impairment: 25). The patients were randomly assigned to use 0.1%, 0.5% or 1% aroma bath salt. During daily bathing, bath salt was added to the bath water, and the subjects remained in the bathroom for ≥10 min. The intervention period was 24 weeks, and the observation periods were 4 weeks before and after using the aroma bath salt. We performed the Touch Panel-type Dementia Assessment Scale (TDAS), the Odour Stick Identification Test for Japanese (OSIT-J) and the Japanese version of the Pittsburgh Sleep Quality Index (PSQI-J) five times during the before and after observation periods and after the 12-week intervention.
RESULTS


There were no significant changes in the TDAS, OSIT-J and PSQI-J scores before and after the intervention in all groups. Moreover, there were no significant differences in the TDAS, OSIT-J and PSQI-J scores between the groups before and after the intervention. In the correlation analysis of changes in the TDAS and other tests during the intervention period, significant associations between TDAS and sleep latency and sleep disturbances, which are sub-items of PSQI-J, were observed in the use of 0.1% aroma bath salt group.
CONCLUSIONS


The use of aroma bath salt was not associated with improvement in cognitive function, olfactory function or sleep quality. However, sleep-related aspects were associated with changes in cognitive function before and after use of aroma bath salt, which suggested that there is a link between improvements in sleep and that in cognitive function.",2020,"There were no significant changes in the TDAS, OSIT-J and PSQI-J scores before and after the intervention in all groups.","[""49 patients were able to provide consent, and 35 were finally analysed (Alzheimer's disease: 10, mild cognitive impairment: 25""]",['aroma oil'],"['cognitive function, olfactory function or sleep quality', 'cognitive function', 'Touch Panel-type Dementia Assessment Scale (TDAS), the Odour Stick Identification Test for Japanese (OSIT-J) and the Japanese version of the Pittsburgh Sleep Quality Index (PSQI-J', 'cognitive function, olfactory function and sleep quality', 'TDAS and sleep latency and sleep disturbances', 'TDAS, OSIT-J and PSQI-J scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299581', 'cui_str': 'Able'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}]","[{'cui': 'C2987717', 'cui_str': 'Aroma'}, {'cui': 'C0028908', 'cui_str': 'Oils'}]","[{'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0439826', 'cui_str': 'Olfactory (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0152054', 'cui_str': 'Therapeutic Touch'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales (assessment scale)'}, {'cui': 'C4318418', 'cui_str': 'Stick'}, {'cui': 'C0020792', 'cui_str': 'Identification'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C3697468', 'cui_str': 'PSQI - Pittsburgh sleep quality index'}, {'cui': 'C4505222', 'cui_str': 'REM Sleep Latency'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnias'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",49.0,0.0212657,"There were no significant changes in the TDAS, OSIT-J and PSQI-J scores before and after the intervention in all groups.","[{'ForeName': 'Minoru', 'Initials': 'M', 'LastName': 'Kouzuki', 'Affiliation': 'Department of Biological Regulation, School of Health Science, Faculty of Medicine, Tottori University, Yonago, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Kitao', 'Affiliation': 'Fuji Sangyo Co., Ltd., 1301, Tamura-cho, Marugame, Kagawa, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Kaju', 'Affiliation': 'Fuji Sangyo Co., Ltd., 1301, Tamura-cho, Marugame, Kagawa, Japan.'}, {'ForeName': 'Katsuya', 'Initials': 'K', 'LastName': 'Urakami', 'Affiliation': 'Department of Biological Regulation, School of Health Science, Faculty of Medicine, Tottori University, Yonago, Japan.'}]",Psychogeriatrics : the official journal of the Japanese Psychogeriatric Society,['10.1111/psyg.12481']
546,31584311,"Effects of Dried Apple Consumption on Body Composition, Serum Lipid Profile, Glucose Regulation, and Inflammatory Markers in Overweight and Obese Children.","Consumption of fruits reduces the risk of chronic diseases such as cardiovascular disease; however, very few studies have investigated the effect of fruit consumption in overweight and obese children. We examined whether consuming dried apple as a snack is a practical solution for weight loss and improves body composition and metabolic markers. Thirty-eight overweight or obese children aged 10 to 16 years were randomly assigned to one of two groups consuming twice daily 120 kcal serving per day of either dried apple or a control snack (muffin) for 8 weeks. Body weight, height, waist circumference, and body composition were determined during an initial visit and after 8 weeks of intervention. Blood samples were collected to measure serum concentrations of blood lipids, glucose, insulin, proinsulin, total adiponectin, and C-reactive protein, as well as total antioxidant capacity and activity of glutathione peroxidase. Body weight increased in the muffin group ( P  = .01). BodPod and dual-energy X-ray absorptiometry showed that fat-free mass increased ( P  < .05) only in the muffin group. High-density lipoprotein cholesterol concentration increased ( P  = .04) after the 8-week treatment within the apple group. Overall, minor differences were detected in growing children who consumed snacks of either dried apples or muffins with similar macronutrient profiles for 8 weeks. Future research should evaluate the effects of consuming fresh apples that include the peel.",2020,High-density lipoprotein cholesterol concentration increased ( P  = .04) after the 8-week treatment within the apple group.,"['Thirty-eight overweight or obese children aged 10 to 16 years', 'overweight and obese children', 'Overweight and Obese Children']",['Dried Apple Consumption'],"['Body weight, height, waist circumference, and body composition', 'High-density lipoprotein cholesterol concentration', 'serum concentrations of blood lipids, glucose, insulin, proinsulin, total adiponectin, and C-reactive protein, as well as total antioxidant capacity and activity of glutathione peroxidase', 'Body Composition, Serum Lipid Profile, Glucose Regulation, and Inflammatory Markers', 'weight loss and improves body composition and metabolic markers', 'Body weight']","[{'cui': 'C0450361', 'cui_str': '38 (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0453298', 'cui_str': 'Dried apple (substance)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0023822', 'cui_str': 'High Density Lipoprotein Cholesterol'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005768'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0033362', 'cui_str': 'Proinsulin'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0017822', 'cui_str': 'Glutathione:hydrogen-peroxide oxidoreductase'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C1513159', 'cui_str': 'Metabolic marker (substance)'}]",38.0,0.0207983,High-density lipoprotein cholesterol concentration increased ( P  = .04) after the 8-week treatment within the apple group.,"[{'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Eisner', 'Affiliation': 'School of Exercise and Nutritional Sciences, San Diego State University, San Diego, California, USA.'}, {'ForeName': 'Pavithra', 'Initials': 'P', 'LastName': 'Ramachandran', 'Affiliation': 'School of Exercise and Nutritional Sciences, San Diego State University, San Diego, California, USA.'}, {'ForeName': 'Conralyn', 'Initials': 'C', 'LastName': 'Cabalbag', 'Affiliation': 'School of Exercise and Nutritional Sciences, San Diego State University, San Diego, California, USA.'}, {'ForeName': 'Dina', 'Initials': 'D', 'LastName': 'Metti', 'Affiliation': 'School of Exercise and Nutritional Sciences, San Diego State University, San Diego, California, USA.'}, {'ForeName': 'Pouneh', 'Initials': 'P', 'LastName': 'Shamloufard', 'Affiliation': 'School of Exercise and Nutritional Sciences, San Diego State University, San Diego, California, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Kern', 'Affiliation': 'School of Exercise and Nutritional Sciences, San Diego State University, San Diego, California, USA.'}, {'ForeName': 'Mee Young', 'Initials': 'MY', 'LastName': 'Hong', 'Affiliation': 'School of Exercise and Nutritional Sciences, San Diego State University, San Diego, California, USA.'}, {'ForeName': 'Shirin', 'Initials': 'S', 'LastName': 'Hooshmand', 'Affiliation': 'School of Exercise and Nutritional Sciences, San Diego State University, San Diego, California, USA.'}]",Journal of medicinal food,['10.1089/jmf.2019.0044']
547,32112140,Influence of Ranibizumab versus laser photocoagulation on radiation retinopathy (RadiRet) - a prospective randomized controlled trial.,"PURPOSE


To demonstrate superiority of intravitreal ranibizumab 0.5 mg compared to focal and peripheral laser treatment in patients with radiation retinopathy for choroidal melanoma.
METHODS


Inclusion criteria were as follows: patients with radiation retinopathy and visual acuity impairment due to radiation maculopathy accessible for laser therapy, age ≥ 18 years, and BCVA less than 20/32. The main objective was to study the change in best-corrected visual acuity (BCVA) over 6 months from ranibizumab 0.5 mg (experimental) compared to focal laser of the macula and panretinal laser treatment of the ischemic retina (control) in patients with radiation retinopathy in choroidal melanoma. The secondary objectives of the radiation retinopathy study were to compare functional and anatomical results between ranibizumab and laser group over 12 months and to measure the frequency of vitreous hemorrhage and rubeosis iridis.
RESULTS


The intention-to-treat analysis included 31 patients assigned to ranibizumab (n = 15) or laser treatment (n = 16). In terms of BCVA at month 6, ranibizumab was superior to laser treatment, with an advantage of 0.14 logMAR, 95% CI 0.01 to 0.25, p = 0.030. The positive effect of ranibizumab disappeared after treatment was discontinued. Similar results without statistically significant difference were found with respect to macular thickness. In both groups, no change was observed at month 6 in the size of ischemia in the macula or periphery compared to baseline. There was 1 case of vitreous hemorrhage in the laser group and no case of rubeosis iridis over time.
CONCLUSIONS


This study showed a statistically significant improvement in visual acuity and clear superiority of ranibizumab compared to laser treatment up to 26 weeks, but this effect disappeared at week 52 after completion of intravitreal treatment. Ranibizumab and PRP are considered equivalent in terms of the non-appearance of proliferative radiation retinopathy during the study.
TRIAL REGISTRATION


EudraCT Number: 2011-004463-69.",2020,"In both groups, no change was observed at month 6 in the size of ischemia in the macula or periphery compared to baseline.","['patients with radiation retinopathy for choroidal melanoma', 'Inclusion criteria were as follows: patients with radiation retinopathy and visual acuity impairment due to radiation maculopathy accessible for laser therapy, age\u2009≥', 'patients with radiation retinopathy in choroidal melanoma']","['ranibizumab and laser', 'ranibizumab', 'peripheral laser treatment', 'intravitreal ranibizumab', 'laser treatment', 'Ranibizumab and PRP', 'ranibizumab 0.5\xa0mg (experimental) compared to focal laser of the macula and panretinal laser treatment of the ischemic retina (control', 'laser photocoagulation', 'Ranibizumab']","['vitreous hemorrhage', 'frequency of vitreous hemorrhage and rubeosis iridis', 'best-corrected visual acuity (BCVA', 'macular thickness', 'visual acuity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0339483', 'cui_str': 'Radiation retinopathy (disorder)'}, {'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0730362', 'cui_str': 'Maculopathy'}, {'cui': 'C1955835', 'cui_str': 'Laser Therapy'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0242848', 'cui_str': 'PrP (GSS)'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0205234', 'cui_str': 'Focal (qualifier value)'}, {'cui': 'C0332573', 'cui_str': 'Macule (morphologic abnormality)'}, {'cui': 'C0442132', 'cui_str': 'Panretinal (qualifier value)'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0035298', 'cui_str': 'Retina'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0023694', 'cui_str': 'Photocoagulation'}]","[{'cui': 'C0042909', 'cui_str': 'Vitreous Hemorrhage'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0154916', 'cui_str': 'Rubeosis iridis (disorder)'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}]",31.0,0.129802,"In both groups, no change was observed at month 6 in the size of ischemia in the macula or periphery compared to baseline.","[{'ForeName': 'Ira', 'Initials': 'I', 'LastName': 'Seibel', 'Affiliation': 'Department of Ophthalmology, Charité University Medicine Berlin, Hindenburgdamm 30, 12200, Berlin, Germany.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Vollhardt', 'Affiliation': 'Department of Ophthalmology, Charité University Medicine Berlin, Hindenburgdamm 30, 12200, Berlin, Germany.'}, {'ForeName': 'Aline I', 'Initials': 'AI', 'LastName': 'Riechardt', 'Affiliation': 'Department of Ophthalmology, Charité University Medicine Berlin, Hindenburgdamm 30, 12200, Berlin, Germany.'}, {'ForeName': 'Matus', 'Initials': 'M', 'LastName': 'Rehak', 'Affiliation': 'Department of Ophthalmology, Charité University Medicine Berlin, Hindenburgdamm 30, 12200, Berlin, Germany.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Schmied', 'Affiliation': 'Clinical Trial Centre Cologne (CTCC), University of Cologne, Gleueler Str. 269, 50935, Cologne, Germany.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Schiller', 'Affiliation': 'Institute of Medical Statistics and Computational Biology (IMSB), University of Cologne, Bachemer Str. 86, 50931, Cologne, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Zeitz', 'Affiliation': 'Department of Ophthalmology, Charité University Medicine Berlin, Hindenburgdamm 30, 12200, Berlin, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Hellmich', 'Affiliation': 'Institute of Medical Statistics and Computational Biology (IMSB), University of Cologne, Bachemer Str. 86, 50931, Cologne, Germany.'}, {'ForeName': 'Antonia M', 'Initials': 'AM', 'LastName': 'Joussen', 'Affiliation': 'Department of Ophthalmology, Charité University Medicine Berlin, Hindenburgdamm 30, 12200, Berlin, Germany. antonia.joussen@charite.de.'}]",Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie,['10.1007/s00417-020-04618-7']
548,31831574,Reducing weight and increasing physical activity in people at high risk of cardiovascular disease: a randomised controlled trial comparing the effectiveness of enhanced motivational interviewing intervention with usual care.,"OBJECTIVE


The epidemic of obesity is contributing to the increasing prevalence of people at high risk of cardiovascular disease (CVD), negating the medical advances in reducing CVD mortality. We compared the clinical and cost-effectiveness of an intensive lifestyle intervention consisting of enhanced motivational interviewing in reducing weight and increasing physical activity for patients at high risk of CVD.
METHODS


A three-arm, single-blind, parallel-group randomised controlled trial was conducted in consenting primary care centres in south London. We recruited patients aged 40-74 years with a QRisk2 score ≥20.0%, which indicates the probability of having a CVD event in the next 10 years. The intervention was enhanced motivational interviewing which included additional behaviour change techniques and was delivered by health trainers in 10 sessions over 1 year, in either group (n=697) or individual (n=523) format. The third arm received usual care (UC; n=522). The primary outcomes were physical activity (mean steps/day) and weight (kg). Secondary outcomes were changes in low-density lipoprotein cholesterol and CVD risk score. We estimated the relative cost-effectiveness of each intervention.
RESULTS


At 24 months, the group and individual interventions were not more effective than UC in increasing physical activity (mean difference=70.05 steps, 95% CI -288.00 to 147.90 and mean difference=7.24 steps, 95% CI -224.01 to 238.50, respectively), reducing weight (mean difference=-0.03 kg, 95% CI -0.49 to 0.44 and mean difference=-0.42 kg, 95% CI -0.93 to 0.09, respectively) or improving any secondary outcomes. The group and individual interventions were not cost-effective at conventional thresholds.
CONCLUSIONS


Enhancing motivational interviewing with additional behaviour change techniques was not effective in reducing weight or increasing physical activity in those at high CVD risk.",2020,"At 24 months, the group and individual interventions were not more effective than UC in increasing physical activity (mean difference=70.05 steps, 95% CI -288.00 to 147.90 and mean difference=7.24 steps, 95% CI -224.01 to 238.50, respectively), reducing weight (mean difference=-0.03 kg, 95% CI -0.49 to 0.44 and mean difference=-0.42 kg, 95% CI -0.93 to 0.09, respectively) or improving any secondary outcomes.","['patients at high risk of CVD', 'patients aged 40-74 years with a QRisk2 score ≥20.0%, which indicates the probability of having a CVD event in the next 10 years', 'people at high risk of cardiovascular disease', 'consenting primary care centres in south London']","['enhanced motivational interviewing which included additional behaviour change techniques and was delivered by health trainers', 'intensive lifestyle intervention consisting of enhanced motivational interviewing', 'enhanced motivational interviewing intervention with usual care']","['physical activity', 'weight or increasing physical activity', 'low-density lipoprotein cholesterol and CVD risk score', 'weight and increasing physical activity', 'physical activity (mean steps/day) and weight (kg', 'Reducing weight and increasing physical activity', 'reducing weight']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0023973', 'cui_str': 'London'}]","[{'cui': 'C0683474', 'cui_str': 'Motivational Interviewing'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0453962', 'cui_str': 'Trainers (physical object)'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0935630', 'cui_str': 'Interview'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C4039165', 'cui_str': 'Increased physical activity (finding)'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}]",,0.148609,"At 24 months, the group and individual interventions were not more effective than UC in increasing physical activity (mean difference=70.05 steps, 95% CI -288.00 to 147.90 and mean difference=7.24 steps, 95% CI -224.01 to 238.50, respectively), reducing weight (mean difference=-0.03 kg, 95% CI -0.49 to 0.44 and mean difference=-0.42 kg, 95% CI -0.93 to 0.09, respectively) or improving any secondary outcomes.","[{'ForeName': 'Khalida', 'Initials': 'K', 'LastName': 'Ismail', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK khalida.2.ismail@kcl.ac.uk.""}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Bayley', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Twist', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Kurtis', 'Initials': 'K', 'LastName': 'Stewart', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Ridge', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Britneff', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Greenough', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, UK.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Ashworth', 'Affiliation': ""School of Population Health and Environmental Sciences, King's College London, London, London, UK.""}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Rundle', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Derek G', 'Initials': 'DG', 'LastName': 'Cook', 'Affiliation': ""Division of Population Health Sciences and Education, University of London St George's Molecular and Clinical Sciences Research Institute, London, UK.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Whincup', 'Affiliation': ""Division of Population Health Sciences and Education, University of London St George's Molecular and Clinical Sciences Research Institute, London, UK.""}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Treasure', 'Affiliation': ""Department of Health Services and Population Research, Institute of Psychiatry, King's College London, London, UK.""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'McCrone', 'Affiliation': ""Section of Eating Disorders, Institute of Psychiatry, King's College London, London, UK.""}, {'ForeName': 'Kirsty', 'Initials': 'K', 'LastName': 'Winkley', 'Affiliation': ""Florence Nightingale Faculty of Nursing, Midwifery & Palliative Care, King's College London, London, UK.""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Stahl', 'Affiliation': ""Department of Biostatistics and Health Informatics, Institute of Psychiatry, King's College London, London, UK.""}]",Heart (British Cardiac Society),['10.1136/heartjnl-2019-315656']
549,32190990,"Bimonthly, treat-and-extend and as-needed ranibizumab in naïve neovascular age-related macular degeneration patients: 12-month outcomes of a randomized study.","PURPOSE


To assess the noninferiority of the treat-and-extend (T&E) and fixed bimonthly regimens of 0.5 mg intravitreal ranibizumab as compared with the pro re nata (PRN) in naïve patients with neovascular age-related macular degeneration (nAMD).
METHODS


Phase IV, randomized, 12-month, multicentre trial. Patients aged ≥50 years with nAMD and visual impairment [best-corrected visual acuity (BCVA) between 23 and 78 Early Treatment Diabetic Retinopathy Study (ETDRS) letters] were eligible. Patients (one eye per patient) were randomized to bimonthly, n = 103, T&E, n = 99 or PRN, n = 104. Noninferiority was established at five letters ETDRS.
RESULTS


The mean (95% CI) difference in BCVA at 12 months was 7.2 (4.2-10.2), 6.4 (2.9-9.8), and 8.0 (51.1-11.0) in the bimonthly, T&E and PRN, respectively. The bimonthly or T&E regimens were not inferior to the PRN scheme. All regimens were associated with a significant reduction of central subfield thickness and volume. The mean (95% CI) number of injections in the bimonthly regimen (7.6, 7.5-7.7) was similar as compared with the PRN regimen (7.4, 6.7-8.0) (p = 0.159) but lower than in the T&E regimen (9.3, 8.9-9.7) (p < 0.001).
CONCLUSION


At 12 months, bimonthly and T&E ranibizumab were noninferior to PRN in naïve nAMD.",2020,All regimens were associated with a significant reduction of central subfield thickness and volume.,"['Patients aged ≥50\xa0years with nAMD and visual impairment [best-corrected visual acuity (BCVA) between 23 and 78 Early Treatment Diabetic Retinopathy Study (ETDRS) letters', 'naïve neovascular age-related macular degeneration patients', 'naïve patients with neovascular age-related macular degeneration (nAMD', 'Patients (one eye per patient) were randomized to bimonthly, n\xa0']","['intravitreal ranibizumab', 'ranibizumab', 'T&E ranibizumab', 'pro re nata (PRN']","['central subfield thickness and volume', 'BCVA']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3665347', 'cui_str': 'Visual Impairment'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0011884', 'cui_str': 'Diabetic Retinopathy'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C0271084', 'cui_str': 'Neovascular age-related macular degeneration'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0585337', 'cui_str': 'Bimonthly (qualifier value)'}]","[{'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C0067792', 'cui_str': 'NATA'}, {'cui': 'C0558288', 'cui_str': 'prn'}]","[{'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}]",,0.172246,All regimens were associated with a significant reduction of central subfield thickness and volume.,"[{'ForeName': 'María Isabel', 'Initials': 'MI', 'LastName': 'López Gálvez', 'Affiliation': 'Department of Ophthalmology, Hospital Clínico Universitario de Valladolid, Valladolid, Spain.'}, {'ForeName': 'Lluís', 'Initials': 'L', 'LastName': 'Arias Barquet', 'Affiliation': ""Department of Ophthalmology, Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'S Figueroa', 'Affiliation': 'Department of Ophthalmology, Hospital Universitario Ramón y Cajal, Madrid, Spain.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'García-Layana', 'Affiliation': 'Department of Ophthalmology, Clínica Universidad de Navarra, Pamplona, Spain.'}, {'ForeName': 'José M', 'Initials': 'JM', 'LastName': 'Ruiz Moreno', 'Affiliation': 'Department of Ophthalmology, Hospital Universitario Puerta de Hierro-Majadahonda, Madrid, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Acta ophthalmologica,['10.1111/aos.14399']
550,32205111,Ultrasound-Guided Percutaneous Arterial Puncture and Closure Device Training in a Pulsatile Model.,"OBJECTIVE


The current study assesses the feasibility of in vitro practice of percutaneous puncture techniques in a pulsatile flow-model.
DESIGN


Prospective, controlled, randomized study.
SETTING


The percutaneous access to endovascular aortic repair is considered safe, but success rates may be dependent on surgeon experience with the technique.
PARTICIPANTS


Fourteen vascular surgery trainees and consultants were enrolled and randomized to a study or control group with both groups receiving instructions by a tutor on how to perform ultrasound guided percutaneous puncture and closure using a suture-mediated closure device. The study group received additional hands-on training on a pulsatile flowmodel of the groin and the performance of both groups was then graded. Study group participants were timed during and after their training on the model.
RESULTS


The study group achieved higher overall grading than the control group on a 5-point scale with higher scores indicating a better performance (mean overall scores 4.0 ± 0.7 versus 2.8 ± 1.0, respectively; p = 0.03). Experienced participants (more than 20 punctures performed before the study) achieved higher overall scores than trainees (3.8 ± 0.4 versus 2.5 ± 0.8, respectively; p = 0.01). Five participants in the study group could deploy and close the ProGlide closure device correctly without the help of a tutor while being graded (71% in the study versus 0% in the control group; p = 0.02). Study group participants improved their overall score from 3.2 ± 0.9 to 4.0 ± 0.7 during training (p = 0.02). Time needed to complete the puncture and closure reduced from 456 seconds on average before, to 302 seconds after training (p < 0.001).
CONCLUSIONS


Study group participants could improve their overall score while working on the simulator. More experienced participants performed better during the simulation, which may indicate the model to be life-like and a potential skills assessment tool. Simulation training may be a valuable adjunct to traditional forms of training when teaching an endovascular technique but is limited by its reliance on simulators and demo devices.",2020,"Time needed to complete the puncture and closure reduced from 456 seconds on average before, to 302 seconds after training (p < 0.001).
",['Fourteen vascular surgery trainees and consultants'],"['Ultrasound-Guided Percutaneous Arterial Puncture and Closure Device Training', 'endovascular aortic repair', 'control group with both groups receiving instructions by a tutor on how to perform ultrasound guided percutaneous puncture and closure using a suture-mediated closure device', 'percutaneous puncture techniques', 'additional hands-on training', 'Simulation training']",['Time needed to complete the puncture and closure'],"[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C3714645', 'cui_str': 'Vascular surgery'}, {'cui': 'C0009817', 'cui_str': 'Consultant'}]","[{'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach - access (qualifier value)'}, {'cui': 'C0189586', 'cui_str': 'Puncture of artery'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0003483', 'cui_str': 'Aorta'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0033119', 'cui_str': 'Puncture wound - injury (disorder)'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C4042947', 'cui_str': 'Simulation Training'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0033119', 'cui_str': 'Puncture wound - injury (disorder)'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}]",,0.0439961,"Time needed to complete the puncture and closure reduced from 456 seconds on average before, to 302 seconds after training (p < 0.001).
","[{'ForeName': 'Fadi', 'Initials': 'F', 'LastName': 'Taher', 'Affiliation': 'Department of Vascular and Endovascular Surgery, Wilhelminenhospital, Vienna, Austria. Electronic address: fadi.taher@gmail.com.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Plimon', 'Affiliation': 'Department of Vascular and Endovascular Surgery, Wilhelminenhospital, Vienna, Austria.'}, {'ForeName': 'Andrej', 'Initials': 'A', 'LastName': 'Isaak', 'Affiliation': 'Department of Vascular and Endovascular Surgery, University Hospital Basel, Switzerland.'}, {'ForeName': 'Juergen', 'Initials': 'J', 'LastName': 'Falkensammer', 'Affiliation': 'Department of Vascular and Endovascular Surgery, Wilhelminenhospital, Vienna, Austria.'}, {'ForeName': 'Eleonore', 'Initials': 'E', 'LastName': 'Pablik', 'Affiliation': 'Section for Medical Statistics - CeMSIIS, Medical University of Vienna, Austria.'}, {'ForeName': 'Corinna', 'Initials': 'C', 'LastName': 'Walter', 'Affiliation': 'Department of Vascular and Endovascular Surgery, Wilhelminenhospital, Vienna, Austria.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Kliewer', 'Affiliation': 'Department of Vascular and Endovascular Surgery, Wilhelminenhospital, Vienna, Austria.'}, {'ForeName': 'Afshin', 'Initials': 'A', 'LastName': 'Assadian', 'Affiliation': 'Department of Vascular and Endovascular Surgery, Wilhelminenhospital, Vienna, Austria.'}]",Journal of surgical education,['10.1016/j.jsurg.2020.02.032']
551,32205125,Five-year extension study of patients from a randomized clinical trial (VeClose) comparing cyanoacrylate closure versus radiofrequency ablation for the treatment of incompetent great saphenous veins.,"OBJECTIVE


The proprietary cyanoacrylate closure (CAC) system vs radiofrequency ablation (RFA) trial (VenaSeal Sapheon Closure System Pivotal Study [VeClose]) showed that CAC, a nontumescent, nonthermal, nonsclerosant ablation technique, was effective and noninferior to RFA in vein closure with good 36-month outcomes. Conducted under a separate protocol, the aim of this extended follow-up was to assess the long-term safety and effectiveness of CAC and RFA for the treatment of incompetent great saphenous veins (GSV) at 5 years (60 months) of follow-up.
METHODS


This 60-month extension study was conducted for all patients who completed the randomized VeClose study and who were willing to participate. The pivotal VeClose study included patients with symptomatic moderate to severe varicosities (Clinical, Etiology, Anatomy, and Pathophysiology [CEAP] class C2-C4b) and symptomatic GSV incompetence who were randomly assigned (1:1) to either CAC or RFA. The primary outcome measure of this 60-month extension study was complete closure of the target vein, with planned exploratory analysis of noninferiority. Secondary outcomes included CEAP class; completion of the Venous Clinical Severity Score, EuroQol-Five Dimension survey, and Aberdeen Varicose Vein Questionnaire; patient satisfaction with treatment; adverse events (AEs) related to target GSV; and details of adjunctive procedures.
RESULTS


A total of 89 patients completed the 60-month visit, which included 47 from the CAC group, 33 from the RFA group, and 9 CAC roll-in patients. No new recanalization events have been observed in the groups between 36 and 60 months of follow-up. At 60 months, Kaplan-Meier estimates for freedom from recanalization in the randomized CAC and RFA groups were 91.4% and 85.2%, respectively, demonstrating noninferiority of CAC compared with RFA. Both groups demonstrated sustained improvements in EuroQol-Five Dimension and quality of life measures through 60 months. Whereas patients assigned to C0 or C1 clinical class were excluded from the original study, more than half of all returning patients (64% [57/89]) were now assigned to C0 or C1, suggesting an improved clinical class from baseline. Furthermore, 41.1% of returning CAC patients and 39.4% of returning RFA patients are presently at least two CEAP clinical classes lower than at baseline. No long-term device- or procedure-related serious AEs occurred in either group between 36- and 60-month follow-up.
CONCLUSIONS


CAC and RFA were effective in achieving complete target vein closure of the GSV at long-term follow-up, with CAC demonstrating continued noninferiority to RFA. CAC was also associated with sustained improvements in symptoms and quality of life, lower CEAP class, and high level of patient satisfaction without serious AEs between 36 and 60 months.",2020,"No long-term device- or procedure-related serious AEs occurred in either group between 36- and 60-month follow-up.
","['all patients who completed the randomized VeClose study and who were willing to participate', 'patients with symptomatic moderate to severe varicosities (Clinical, Etiology, Anatomy, and Pathophysiology [CEAP] class C2-C4b) and symptomatic GSV incompetence', 'incompetent great saphenous veins', 'incompetent great saphenous veins (GSV) at 5\xa0years (60\xa0months) of follow-up', '89 patients completed the 60-month visit, which included 47 from the CAC group, 33 from the RFA group, and 9 CAC roll-in patients']","['CAC or RFA', 'CAC', 'cyanoacrylate closure versus radiofrequency ablation', 'proprietary cyanoacrylate closure (CAC) system vs radiofrequency ablation (RFA', 'CAC and RFA']","['symptoms and quality of life, lower CEAP class, and high level of patient satisfaction without serious AEs', 'EuroQol-Five Dimension and quality of life measures', 'complete closure of the target vein', 'No long-term device- or procedure-related serious AEs', 'CEAP class; completion of the Venous Clinical Severity Score, EuroQol-Five Dimension survey, and Aberdeen Varicose Vein Questionnaire; patient satisfaction with treatment; adverse events (AEs) related to target GSV; and details of adjunctive procedures']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0600109', 'cui_str': 'Willing (finding)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0042345', 'cui_str': 'Varices'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0015127', 'cui_str': 'causes'}, {'cui': 'C0002808', 'cui_str': 'Anatomy'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0231179', 'cui_str': 'Insufficiency (finding)'}, {'cui': 'C0392907', 'cui_str': 'Great saphenous vein structure'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0010507', 'cui_str': 'Cyanoacrylates'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}, {'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034380'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}, {'cui': 'C0042449', 'cui_str': 'Veins'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0348013', 'cui_str': 'Venous (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0457451', 'cui_str': 'Severity score (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0042345', 'cui_str': 'Varices'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",89.0,0.0829746,"No long-term device- or procedure-related serious AEs occurred in either group between 36- and 60-month follow-up.
","[{'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Morrison', 'Affiliation': 'Center for Vein Restoration, Mesa, Ariz. Electronic address: nickmorrison2002@yahoo.com.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Gibson', 'Affiliation': 'Lake Washington Vascular, Bellevue, Wash.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Vasquez', 'Affiliation': 'Venous Institute of Buffalo, Buffalo, NY.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Weiss', 'Affiliation': 'Maryland Laser Skin & Vein, Hunt Valley, MD.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Jones', 'Affiliation': 'Inovia Vein Specialty Center, Bend, Ore.'}]",Journal of vascular surgery. Venous and lymphatic disorders,['10.1016/j.jvsv.2019.12.080']
552,32088174,"Multicenter, open-label trial to assess the safety and tolerability of drospirenone 4.0 mg over 6 cycles in female adolescents, with a 7-cycle extension phase.","OBJECTIVE


To assess the safety, tolerability and bleeding patterns of drospirenone 4.0 mg.
STUDY DESIGN


A multicenter, open-label, safety trial in sexually-active adolescents aged 12-17 years for six 28-day treatment cycles (Core Phase) and an optional 7-13 cycle extension with administration of drospirenone 4.0 mg in a regimen of 24 active/4 placebo tablets.
RESULTS


We enrolled 111 subjects, and after eight failed Screening and one withdrew consent, 102 remained evaluable; 89 (87.3%) completed the Core Phase. Overall, treatment with drospirenone 4.0 mg was well tolerated. Possibly-related TEAEs were reported for 23 subjects (22.5% of the 102 evaluable); two serious adverse events were reported during the Extension Phase (pharyngitis and joint dislocation), neither related to treatment. The number of subjects reporting dysmenorrhea decreased from 47 prior to Screening, to 14 at the end of Cycle 6, to 8 at the end of Cycle 13. Assessments of vital signs and gynecological and physical examinations were unremarkable. We observed a trend towards less bleeding and/or spotting over the first cycles with the use of drospirenone: the proportion of subjects with both scheduled and unscheduled bleeding and spotting decreased, while the proportion with absence of bleeding or spotting increased. Only five subjects (4.9% of 102 evaluable) prematurely terminated the trial due to irregular bleeding. At the end of 6 months, 85.3% rated the tolerability of drospirenone as ""excellent"" or ""good"".
CONCLUSIONS


The results indicate that 4.0 mg drospirenone over 13 treatment cycles was well tolerated, safe and acceptable for the majority of adolescents.
IMPLICATIONS


Drospirenone 4.0 mg oral pills provide a well-tolerated, safe and acceptable contraceptive choice for adolescents.",2020,"We observed a trend towards less bleeding and/or spotting over the first cycles with the use of drospirenone: the proportion of subjects with both scheduled and unscheduled bleeding and spotting decreased, while the proportion with absence of bleeding or spotting increased.","['We enrolled 111 subjects, and after eight failed Screening and one withdrew consent, 102 remained evaluable; 89 (87.3%) completed the Core Phase', 'Female Adolescents', 'sexually-active adolescents aged 12-17 years for six 28-day treatment cycles (Core Phase) and an optional 7-13 cycle extension with administration of', 'adolescents']","['drospirenone', 'Drospirenone', 'drospirenone 4.0 mg in a regimen of 24 active/4 placebo tablets']","['serious adverse events', 'bleeding and/or spotting', 'unscheduled bleeding and spotting', 'tolerated', 'tolerated, safe and acceptable for the majority of adolescents', 'irregular bleeding', 'tolerated, safe and acceptable contraceptive choice', 'tolerability', 'safety, tolerability and bleeding patterns', 'number of subjects reporting dysmenorrhea', 'Safety and Tolerability']","[{'cui': 'C4517538', 'cui_str': '111 (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C0241028', 'cui_str': 'Sexually active (finding)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C0043822', 'cui_str': 'drospirenone'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0848332', 'cui_str': 'Spots on skin (disorder)'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205271', 'cui_str': 'Irregular (qualifier value)'}, {'cui': 'C0009871', 'cui_str': 'Contraceptives'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0013390', 'cui_str': 'Pain, Menstrual'}]",111.0,0.0285746,"We observed a trend towards less bleeding and/or spotting over the first cycles with the use of drospirenone: the proportion of subjects with both scheduled and unscheduled bleeding and spotting decreased, while the proportion with absence of bleeding or spotting increased.","[{'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Apter', 'Affiliation': 'VL-Medi Clinical Research Center, Töölönkatu 37, 00260 Helsinki, Finland. Electronic address: dan.apter@vlmedi.fi.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Colli', 'Affiliation': 'Exeltis Spain, Madrid, Spain.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Gemzell-Danielsson', 'Affiliation': ""Department of Women's and Children's Health, Karolinska Institutet, and Karolinska University Hospital, 171 77 Stockholm, Sweden.""}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Peters', 'Affiliation': 'Praxis Dr. Peters, Berner Heerweg 157, 22159 Hamburg, Germany.'}]",Contraception,['10.1016/j.contraception.2020.02.004']
553,31548678,Brain regulation of emotional conflict predicts antidepressant treatment response for depression.,"The efficacy of antidepressant treatment for depression is controversial due to the only modest superiority demonstrated over placebo. However, neurobiological heterogeneity within depression may limit overall antidepressant efficacy. We sought to identify a neurobiological phenotype responsive to antidepressant treatment by testing pretreatment brain activation during response to, and regulation of, emotional conflict as a moderator of the clinical benefit of the antidepressant sertraline versus placebo. Using neuroimaging data from a large randomized controlled trial, we found widespread moderation of clinical benefits by brain activity during regulation of emotional conflict, in which greater downregulation of conflict-responsive regions predicted better sertraline outcomes. Treatment-predictive machine learning using brain metrics outperformed a model trained on clinical and demographic variables. Our findings demonstrate that antidepressant response is predicted by brain activity underlying a key self-regulatory emotional capacity. Leveraging brain-based measures in psychiatry will forge a path toward better treatment personalization, refined mechanistic insights and improved outcomes.",2019,"Using neuroimaging data from a large randomized controlled trial, we found widespread moderation of clinical benefits by brain activity during regulation of emotional conflict, in which greater downregulation of conflict-responsive regions predicted better sertraline outcomes.",[],['placebo'],[],[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.0530251,"Using neuroimaging data from a large randomized controlled trial, we found widespread moderation of clinical benefits by brain activity during regulation of emotional conflict, in which greater downregulation of conflict-responsive regions predicted better sertraline outcomes.","[{'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Fonzo', 'Affiliation': 'Department of Psychiatry, Dell Medical School, The University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Etkin', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA. amitetkin@stanford.edu.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wu', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Crystal', 'Initials': 'C', 'LastName': 'Cooper', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Cherise', 'Initials': 'C', 'LastName': 'Chin-Fatt', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Manish K', 'Initials': 'MK', 'LastName': 'Jha', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Trombello', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Thilo', 'Initials': 'T', 'LastName': 'Deckersbach', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Phil', 'Initials': 'P', 'LastName': 'Adams', 'Affiliation': 'New York State Psychiatric Institute and Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York, NY, USA.'}, {'ForeName': 'Melvin', 'Initials': 'M', 'LastName': 'McInnis', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'McGrath', 'Affiliation': 'New York State Psychiatric Institute and Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York, NY, USA.'}, {'ForeName': 'Myrna M', 'Initials': 'MM', 'LastName': 'Weissman', 'Affiliation': 'New York State Psychiatric Institute and Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York, NY, USA.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Fava', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Madhukar H', 'Initials': 'MH', 'LastName': 'Trivedi', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}]",Nature human behaviour,['10.1038/s41562-019-0732-1']
554,32016407,How the presentation of patient information and decision-support advisories influences opioid prescribing behavior: A simulation study.,"OBJECTIVE


The United States faces an opioid crisis. Integrating prescription drug monitoring programs into electronic health records offers promise to improve opioid prescribing practices. This study aimed to evaluate 2 different user interface designs for prescription drug monitoring program and electronic health record integration.
MATERIALS AND METHODS


Twenty-four resident physicians participated in a randomized controlled experiment using 4 simulated patient cases. In the conventional condition, prescription opioid histories were presented in tabular format, and computerized clinical decision support (CDS) was provided via interruptive modal dialogs (ie, pop-ups). The alternative condition featured a graphical opioid history, a cue to visit that history, and noninterruptive CDS. Two attending pain specialists judged prescription appropriateness.
RESULTS


Participants in the alternative condition wrote more appropriate prescriptions. When asked after the experiment, most participants stated that they preferred the alternative design to the conventional design.
CONCLUSIONS


How patient information and CDS are presented appears to have a significant influence on opioid prescribing behavior.",2020,"RESULTS


Participants in the alternative condition wrote more appropriate prescriptions.","['Participants in the alternative condition wrote more appropriate prescriptions', 'Twenty-four resident physicians participated']",[],[],"[{'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C1320928', 'cui_str': 'Resident physician (occupation)'}]",[],[],24.0,0.0260701,"RESULTS


Participants in the alternative condition wrote more appropriate prescriptions.","[{'ForeName': 'Mustafa I', 'Initials': 'MI', 'LastName': 'Hussain', 'Affiliation': 'Department of Informatics, University of California, Irvine, Irvine, California, USA.'}, {'ForeName': 'Ariana M', 'Initials': 'AM', 'LastName': 'Nelson', 'Affiliation': 'Department of Anesthesiology and Perioperative Care, School of Medicine, University of California, Irvine, Irvine, California, USA.'}, {'ForeName': 'Brent G', 'Initials': 'BG', 'LastName': 'Yeung', 'Affiliation': 'Department of Anesthesiology and Perioperative Care, School of Medicine, University of California, Irvine, Irvine, California, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Sukumar', 'Affiliation': 'Departments of Computer Science and Information Systems and Decision Sciences, California State University, Fullerton, Fullerton, California, USA.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Zheng', 'Affiliation': 'Department of Informatics, University of California, Irvine, Irvine, California, USA.'}]",Journal of the American Medical Informatics Association : JAMIA,['10.1093/jamia/ocz213']
555,32130058,"Efficacy and Safety of Sinetrol-XPur on Weight and Body Fat Reduction in Overweight or Obese Adults: A 12-Week, Randomized, Double-Blind, Parallel, Placebo-Controlled Trial.","This study investigated the effect of Sinetrol-XPur on weight and body fat reduction in overweight or obese Korean participants. Among 100 overweight or obese participants enrolled in a 12-week randomized, double-blinded, controlled study, 86 participants completed the trial. Participants took either two Sinetrol-XPur tablets (450 mg per tablet) or two placebo tablets once a day. Bodyweight, body fat percentage, body mass index (BMI), body fat mass, waist circumference, and various safety parameters were measured. After the 12-week intervention, a significant reduction was observed in the body fat mass ( P  = .030) by dual-energy X-ray absorptiometry (DEXA), body weight ( P  = .002), and BMI ( P  = .002) compared to the placebo. Body fat percentage ( P  = .007) by DEXA showed a significant reduction in the Sinetrol-XPur group, but no difference compared to the control group. Abdominal metabolic risks by computed tomography and blood biochemistry analysis were significantly decreased in the Sinetrol-XPur group, but there were no differences between the Sinetrol-XPur and placebo groups. Safety profiles were not different between the two groups. These results suggested that Sinetrol-XPur significantly reduced body weight, body fat mass, and BMI in obese Korean subjects, which confirms the antiobesity effect of Sinetrol-XPur in the Korean population.",2020,"Abdominal metabolic risks by computed tomography and blood biochemistry analysis were significantly decreased in the Sinetrol-XPur group, but there were no differences between the Sinetrol-XPur and placebo groups.","['obese Korean subjects', '86 participants completed the trial', 'overweight or obese Korean participants', 'Overweight or Obese Adults', '100 overweight or obese participants']","['DEXA', 'Sinetrol-XPur', 'Sinetrol-XPur tablets', 'placebo tablets', 'Placebo']","['Abdominal metabolic risks by computed tomography and blood biochemistry analysis', 'Safety profiles', 'Weight and Body Fat Reduction', 'Bodyweight, body fat percentage, body mass index (BMI), body fat mass, waist circumference, and various safety parameters', 'Body fat percentage', 'BMI', 'weight and body fat reduction', 'body fat mass', 'body weight, body fat mass, and BMI', 'dual-energy X-ray absorptiometry (DEXA), body weight']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1556095', 'cui_str': 'Koreans'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0005768'}, {'cui': 'C0005477', 'cui_str': 'Biochemistry'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C1510486', 'cui_str': 'Dual X-Ray Absorptiometry'}]",86.0,0.110182,"Abdominal metabolic risks by computed tomography and blood biochemistry analysis were significantly decreased in the Sinetrol-XPur group, but there were no differences between the Sinetrol-XPur and placebo groups.","[{'ForeName': 'Seon-Joo', 'Initials': 'SJ', 'LastName': 'Park', 'Affiliation': 'Department of Food and Nutrition, College of BioNano Technology, Gachon University, Seongnam, Gyeonggi-do, Korea.'}, {'ForeName': 'Anshul', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'Department of Food and Nutrition, College of BioNano Technology, Gachon University, Seongnam, Gyeonggi-do, Korea.'}, {'ForeName': 'Mun Hyoung', 'Initials': 'MH', 'LastName': 'Bae', 'Affiliation': 'Rpbio Co. Ltd. Korea, Seoul, Korea.'}, {'ForeName': 'Ha Chang', 'Initials': 'HC', 'LastName': 'Sung', 'Affiliation': 'Rpbio Co. Ltd. Korea, Seoul, Korea.'}, {'ForeName': 'Nam Ki', 'Initials': 'NK', 'LastName': 'Kim', 'Affiliation': 'Rpbio Co. Ltd. Korea, Seoul, Korea.'}, {'ForeName': 'Eunju', 'Initials': 'E', 'LastName': 'Sung', 'Affiliation': 'Department of Family Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Hae-Jeung', 'Initials': 'HJ', 'LastName': 'Lee', 'Affiliation': 'Department of Food and Nutrition, College of BioNano Technology, Gachon University, Seongnam, Gyeonggi-do, Korea.'}]",Journal of medicinal food,['10.1089/jmf.2019.4649']
556,31444692,Phase I Safety Trial: Extended Daily Peripheral Sensory Stimulation Using a Wrist-Worn Vibrator in Stroke Survivors.,"Peripheral sensory stimulation augments post-stroke upper extremity rehabilitation outcomes. Most sensory stimulations interfere with natural hand tasks and the stimulation duration is limited. We developed TheraBracelet, low-level random-frequency vibration applied via a wristwatch, to enable stimulation during hand tasks and potentially extend stimulation durations. To determine safety of prolonged exposure to TheraBracelet. Single-site double-blind crossover randomized controlled trial. Chronic stroke survivors were instructed to wear a device on the affected wrist for > 8 h/day everyday for 2 months while coming to the laboratory weekly for evaluations, with a 2-week break between each month. The device applied vibration at 60% and 1% of the sensory threshold for the real and sham month, respectively. The order of the real and sham months was randomized/balanced. Adverse events (AEs) were assessed weekly, including worsening of hand sensation, dexterity, grip strength, pain, or spasticity and occurrence of skin irritation or swelling. Device-related AE rates were compared between the real and sham month. Twenty-five participants completed the study. Six participants (24%) experienced mild AEs involving worsened sensory scores that may be related to the intervention with reasonable possibility. Two experienced them in the real stimulation month only, 3 in the sham month only, and 1 in both months. Therefore, less participants experienced device-related AEs in the real than sham month. Daily stimulation using the device for a month is safe for chronic stroke survivors. Future studies examining the efficacy of pairing TheraBracelet with therapy for increasing neurorehabilitation outcomes are a logical next step. Trial registration: NCT03318341.",2020,"Adverse events (AEs) were assessed weekly, including worsening of hand sensation, dexterity, grip strength, pain, or spasticity and occurrence of skin irritation or swelling.","['Stroke Survivors', 'Chronic stroke survivors', 'Twenty-five participants completed the study', 'chronic stroke survivors']",['Peripheral sensory stimulation'],"['worsened sensory scores', 'Device-related AE rates', 'worsening of hand sensation, dexterity, grip strength, pain, or spasticity and occurrence of skin irritation or swelling']","[{'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C3536593', 'cui_str': 'Chronic stroke'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0150763', 'cui_str': 'Sensory stimulation'}]","[{'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0036658', 'cui_str': 'Sensory Function'}, {'cui': 'C0565699', 'cui_str': 'Ability to perform general manipulative activities (observable entity)'}, {'cui': 'C0429271', 'cui_str': 'Grip strength (observable entity)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0026838', 'cui_str': 'Muscle Spasticity'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0152030', 'cui_str': 'Skin irritation (disorder)'}]",25.0,0.393901,"Adverse events (AEs) were assessed weekly, including worsening of hand sensation, dexterity, grip strength, pain, or spasticity and occurrence of skin irritation or swelling.","[{'ForeName': 'Na Jin', 'Initials': 'NJ', 'LastName': 'Seo', 'Affiliation': 'Division of Occupational Therapy, Department of Health Professions, Department of Health Sciences and Research, Medical University of South Carolina (MUSC), Charleston, SC, USA. seon@musc.edu.'}, {'ForeName': 'Leah R', 'Initials': 'LR', 'LastName': 'Enders', 'Affiliation': 'TheraBracelet Inc., Louisville, KY, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Fortune', 'Affiliation': 'Department of Health Sciences and Research, MUSC, Charleston, SC, USA.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Cain', 'Affiliation': 'Division of Occupational Therapy, Department of Health Professions, MUSC, Charleston, SC, USA.'}, {'ForeName': 'Amanda A', 'Initials': 'AA', 'LastName': 'Vatinno', 'Affiliation': 'Department of Health Sciences and Research, MUSC, Charleston, SC, USA.'}, {'ForeName': 'Eli', 'Initials': 'E', 'LastName': 'Schuster', 'Affiliation': 'Department of Health Professions, MUSC, Charleston, SC, USA.'}, {'ForeName': 'Viswanathan', 'Initials': 'V', 'LastName': 'Ramakrishnan', 'Affiliation': 'Department of Public Health Sciences, MUSC, Charleston, SC, USA.'}, {'ForeName': 'Wuwei', 'Initials': 'W', 'LastName': 'Feng', 'Affiliation': 'Department of Health Sciences and Research, MUSC, Charleston, SC, USA.'}]",Translational stroke research,['10.1007/s12975-019-00724-9']
557,31855498,Dietary Supplement Use During Chemotherapy and Survival Outcomes of Patients With Breast Cancer Enrolled in a Cooperative Group Clinical Trial (SWOG S0221).,"PURPOSE


Despite reported widespread use of dietary supplements during cancer treatment, few empirical data with regard to their safety or efficacy exist. Because of concerns that some supplements, particularly antioxidants, could reduce the cytotoxicity of chemotherapy, we conducted a prospective study ancillary to a therapeutic trial to evaluate associations between supplement use and breast cancer outcomes.
METHODS


Patients with breast cancer randomly assigned to an intergroup metronomic trial of cyclophosphamide, doxorubicin, and paclitaxel were queried on their use of supplements at registration and during treatment (n =1,134). Cox proportional hazards regression adjusting for clinical and lifestyle variables was used. Recurrence and survival were indexed at 6 months after enrollment using a landmark approach.
RESULTS


There were indications that use of any antioxidant supplement (vitamins A, C, and E; carotenoids; coenzyme Q10) both before and during treatment was associated with an increased hazard of recurrence (adjusted hazard ratio [adjHR], 1.41; 95% CI, 0.98 to 2.04;  P  = .06) and, to a lesser extent, death (adjHR, 1.40; 95% CI, 0.90 to 2.18;  P  = .14). Relationships with individual antioxidants were weaker perhaps because of small numbers. For nonantioxidants, vitamin B12 use both before and during chemotherapy was significantly associated with poorer disease-free survival (adjHR, 1.83; 95% CI, 1.15 to 2.92;  P  < .01) and overall survival (adjHR, 2.04; 95% CI, 1.22 to 3.40;  P  < .01). Use of iron during chemotherapy was significantly associated with recurrence (adjHR, 1.79; 95% CI, 1.20 to 2.67;  P  < .01) as was use both before and during treatment (adjHR, 1.91; 95% CI, 0.98 to 3.70;  P  = .06). Results were similar for overall survival. Multivitamin use was not associated with survival outcomes.
CONCLUSION


Associations between survival outcomes and use of antioxidant and other dietary supplements both before and during chemotherapy are consistent with recommendations for caution among patients when considering the use of supplements, other than a multivitamin, during chemotherapy.",2020,"Use of iron during chemotherapy was significantly associated with recurrence (adjHR, 1.79; 95% CI, 1.20 to 2.67;  P  < .01) as was use both before and during treatment (adjHR, 1.91; 95% CI, 0.98 to 3.70;  P  = .06).","['Patients', 'Patients with breast cancer randomly assigned to an intergroup metronomic trial of']","['Multivitamin', 'cyclophosphamide, doxorubicin, and paclitaxel', 'antioxidant and other dietary supplements', 'dietary supplements', 'Dietary Supplement Use']","['hazard of recurrence', 'Recurrence and survival', 'survival outcomes', 'overall survival', 'poorer disease-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0242295', 'cui_str': 'Dietary Supplementations'}, {'cui': 'C1947944', 'cui_str': 'Use'}]","[{'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}]",1134.0,0.190901,"Use of iron during chemotherapy was significantly associated with recurrence (adjHR, 1.79; 95% CI, 1.20 to 2.67;  P  < .01) as was use both before and during treatment (adjHR, 1.91; 95% CI, 0.98 to 3.70;  P  = .06).","[{'ForeName': 'Christine B', 'Initials': 'CB', 'LastName': 'Ambrosone', 'Affiliation': 'Roswell Park Comprehensive Cancer Center, Buffalo, NY.'}, {'ForeName': 'Gary R', 'Initials': 'GR', 'LastName': 'Zirpoli', 'Affiliation': 'Boston University, Boston, MA.'}, {'ForeName': 'Alan D', 'Initials': 'AD', 'LastName': 'Hutson', 'Affiliation': 'Roswell Park Comprehensive Cancer Center, Buffalo, NY.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'McCann', 'Affiliation': 'Roswell Park Comprehensive Cancer Center, Buffalo, NY.'}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'McCann', 'Affiliation': 'Roswell Park Comprehensive Cancer Center, Buffalo, NY.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Barlow', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Kara M', 'Initials': 'KM', 'LastName': 'Kelly', 'Affiliation': 'Roswell Park Comprehensive Cancer Center, Buffalo, NY.'}, {'ForeName': 'Rikki', 'Initials': 'R', 'LastName': 'Cannioto', 'Affiliation': 'Roswell Park Comprehensive Cancer Center, Buffalo, NY.'}, {'ForeName': 'Lara E', 'Initials': 'LE', 'LastName': 'Sucheston-Campbell', 'Affiliation': 'The Ohio State University, Columbus, OH.'}, {'ForeName': 'Dawn L', 'Initials': 'DL', 'LastName': 'Hershman', 'Affiliation': 'Columbia University, New York, NY.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Unger', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Halle C F', 'Initials': 'HCF', 'LastName': 'Moore', 'Affiliation': 'Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Stewart', 'Affiliation': 'Baystate Medical Center, Springfield, MA.'}, {'ForeName': 'Claudine', 'Initials': 'C', 'LastName': 'Isaacs', 'Affiliation': 'Georgetown University, Washington, DC.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Hobday', 'Affiliation': 'Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Salim', 'Affiliation': 'Allan Blair Cancer Centre, Regina, Saskatchewan, Canada.'}, {'ForeName': 'Gabriel N', 'Initials': 'GN', 'LastName': 'Hortobagyi', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Julie R', 'Initials': 'JR', 'LastName': 'Gralow', 'Affiliation': 'Seattle Cancer Care Alliance, Seattle, WA.'}, {'ForeName': 'George T', 'Initials': 'GT', 'LastName': 'Budd', 'Affiliation': 'Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'Kathy S', 'Initials': 'KS', 'LastName': 'Albain', 'Affiliation': 'Loyola University Chicago Stritch School of Medicine, Chicago, IL.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.01203']
558,31465859,Investigating Gains in Neurocognition in an Intervention Trial of Exercise (IGNITE): Protocol.,"Despite the ubiquity of normal age-related cognitive decline there is an absence of effective approaches for improving neurocognitive health. Fortunately, moderate intensity exercise is a promising method for improving brain and cognitive health in late life, but its effectiveness remains a matter of skepticism and debate because of the absence of large, comprehensive, Phase III clinical trials. Here we describe the protocol for such a randomized clinical trial called IGNITE (Investigating Gains in Neurocognition in an Intervention Trial of Exercise), a study capable of more definitively addressing whether exercise influences cognitive and brain health in cognitively normal older adults. We are conducting a 12-month, multi-site, randomized dose-response exercise trial in 639 cognitively normal adults between 65 and 80 years of age. Participants are randomized to (1) a moderate intensity aerobic exercise condition of 150 min/week (N = 213), (2) a moderate intensity aerobic exercise condition at 225 min/week (N = 213), or (3) a light intensity stretching-and-toning control condition for 150 min/week (N = 213). Participants are engaging in 3 days/week of supervised exercise and two more days per week of unsupervised exercise for 12 months. A comprehensive cognitive battery, blood biomarkers and battery of psychosocial questionnaires is assessed at baseline, 6 and 12-months. In addition, brain magnetic resonance imaging, physiological biomarkers, cardiorespiratory fitness, physical function, and positron emission tomography of amyloid deposition are assessed at baseline and at the 12-month follow-up. The results from this trial could transform scientific-based policy and health care recommendations for approaches to improve cognitive function in cognitively normal older adults.",2019,Despite the ubiquity of normal age-related cognitive decline there is an absence of effective approaches for improving neurocognitive health.,"['cognitively normal older adults', '639 cognitively normal adults between 65 and 80\u202fyears of age']","['moderate intensity aerobic exercise condition of 150\u202fmin/week (N\u202f=\u202f213), (2) a moderate intensity aerobic exercise condition', 'light intensity stretching-and-toning control condition']","['brain magnetic resonance imaging, physiological biomarkers, cardiorespiratory fitness, physical function, and positron emission tomography of amyloid deposition', 'cognitive function', 'comprehensive cognitive battery, blood biomarkers and battery of psychosocial questionnaires']","[{'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0556975', 'cui_str': 'mins/week'}, {'cui': 'C0596836', 'cui_str': 'Low intensity'}, {'cui': 'C0600080', 'cui_str': 'Stretching procedure (procedure)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0032743', 'cui_str': 'Positron-Emission Tomography'}, {'cui': 'C0011560', 'cui_str': 'Amyloid deposition (morphologic abnormality)'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0542351', 'cui_str': 'Battery (event)'}, {'cui': 'C0005768'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.099022,Despite the ubiquity of normal age-related cognitive decline there is an absence of effective approaches for improving neurocognitive health.,"[{'ForeName': 'Kirk I', 'Initials': 'KI', 'LastName': 'Erickson', 'Affiliation': 'Department of Psychology, University of Pittsburgh, USA.; Discipline of Exercise Science, College of Science, Health, Engineering and Education, Murdoch University, Australia. Electronic address: kiericks@pitt.edu.'}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Grove', 'Affiliation': 'Department of Psychology, University of Pittsburgh, USA.'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Burns', 'Affiliation': 'Department of Neurology, University of Kansas Medical Center, USA.'}, {'ForeName': 'Charles H', 'Initials': 'CH', 'LastName': 'Hillman', 'Affiliation': 'Department of Psychology, Northeastern University, USA; Department of Physical Therapy, Movement, & Rehabilitation Sciences, Northeastern University, USA.'}, {'ForeName': 'Arthur F', 'Initials': 'AF', 'LastName': 'Kramer', 'Affiliation': 'Department of Psychology, Northeastern University, USA; Beckman Institute for Advanced Science and Technology, University of Illinois at Urbana Champaign, USA.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'McAuley', 'Affiliation': 'Department of Kinesiology and Community Health, University of Illinois at Urbana Champaign, USA.'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Vidoni', 'Affiliation': 'Department of Neurology, University of Kansas Medical Center, USA.'}, {'ForeName': 'James T', 'Initials': 'JT', 'LastName': 'Becker', 'Affiliation': 'Department of Psychology, University of Pittsburgh, USA.; Department of Psychiatry, University of Pittsburgh, USA; Department of Neurology, University of Pittsburgh, USA.'}, {'ForeName': 'Meryl A', 'Initials': 'MA', 'LastName': 'Butters', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, USA.'}, {'ForeName': 'Katerina', 'Initials': 'K', 'LastName': 'Gray', 'Affiliation': 'Department of Psychology, University of Pittsburgh, USA.'}, {'ForeName': 'Haiqing', 'Initials': 'H', 'LastName': 'Huang', 'Affiliation': 'Department of Psychology, University of Pittsburgh, USA.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Jakicic', 'Affiliation': 'Department of Health and Physical Activity, University of Pittsburgh, USA.'}, {'ForeName': 'M Ilyas', 'Initials': 'MI', 'LastName': 'Kamboh', 'Affiliation': 'Department of Human Genetics, University of Pittsburgh, USA.'}, {'ForeName': 'Chaeryon', 'Initials': 'C', 'LastName': 'Kang', 'Affiliation': 'Department of Biostatistics, University of Pittsburgh, USA.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Klunk', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, USA.'}, {'ForeName': 'Phil', 'Initials': 'P', 'LastName': 'Lee', 'Affiliation': 'Department of Radiology, University of Kansas Medical Center, USA.'}, {'ForeName': 'Anna L', 'Initials': 'AL', 'LastName': 'Marsland', 'Affiliation': 'Department of Psychology, University of Pittsburgh, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Mettenburg', 'Affiliation': 'Department of Radiology, University of Pittsburgh, USA.'}, {'ForeName': 'Renee J', 'Initials': 'RJ', 'LastName': 'Rogers', 'Affiliation': 'Department of Health and Physical Activity, University of Pittsburgh, USA.'}, {'ForeName': 'Chelsea M', 'Initials': 'CM', 'LastName': 'Stillman', 'Affiliation': 'Department of Psychology, University of Pittsburgh, USA.'}, {'ForeName': 'Bradley P', 'Initials': 'BP', 'LastName': 'Sutton', 'Affiliation': 'Beckman Institute for Advanced Science and Technology, University of Illinois at Urbana Champaign, USA.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Szabo-Reed', 'Affiliation': 'Department of Internal Medicine, University of Kansas Medical Center, USA.'}, {'ForeName': 'Timothy D', 'Initials': 'TD', 'LastName': 'Verstynen', 'Affiliation': 'Department of Psychology, Carnegie Mellon University, USA.'}, {'ForeName': 'Jennifer C', 'Initials': 'JC', 'LastName': 'Watt', 'Affiliation': 'Department of Psychology, University of Pittsburgh, USA.'}, {'ForeName': 'Andrea M', 'Initials': 'AM', 'LastName': 'Weinstein', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, USA.'}, {'ForeName': 'Mariegold E', 'Initials': 'ME', 'LastName': 'Wollam', 'Affiliation': 'Department of Psychology, University of Pittsburgh, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105832']
559,31928474,Assessing the Metabolic Impact of Ground Chia Seed in Overweight and Obese Prepubescent Children: Results of a Double-Blind Randomized Clinical Trial.,"Childhood obesity is a medical condition of major public health concern. Chia seeds are used to treat certain noncommunicable diseases, and they are rich in omega-3 fatty acids, which contribute to the absorption of vitamins. A randomized double-blind clinical trial of 30 obese children was performed. The sample was composed of prepubertal 5- to 10-year-old children of both sexes with body mass indexes equal to or above the 95th percentile who were recruited through the Pediatric Department of the Faculdade de Medicina do ABC. Blood samples were drawn, the children were weighed and measured, and a 24-h dietary recall was obtained before and after the treatment. Not only were significant differences observed for fibrinogen ( P  = .011) but a correlation between the changes in markers and the presence of fibers was also observed for two inflammatory parameters: tumor necrosis factor- α  ( P  = .027) and nuclear factor- κβ  ( P  = .059). These results indicate that chia seeds may have anti-inflammatory effects related to their fiber content in the context of childhood obesity.",2020,tumor necrosis factor- α  ( P  = .027) and nuclear factor- κβ  ( P  = .059).,"['30 obese children', 'Overweight and Obese Prepubescent Children', 'prepubertal 5- to 10-year-old children of both sexes with body mass indexes equal to or above the 95th percentile who were recruited through the Pediatric Department of the Faculdade de Medicina do ABC']",['Ground Chia Seed'],"['fibrinogen', 'tumor necrosis factor- α']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0680063', 'cui_str': 'Child of (finding)'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0587482', 'cui_str': 'Pediatric department (environment)'}]","[{'cui': 'C0036563', 'cui_str': 'Zygotes, Plant'}]","[{'cui': 'C0982156', 'cui_str': 'fibrinogen (125I)'}, {'cui': 'C0041368', 'cui_str': 'Tumor Necrosis Factors'}]",30.0,0.0696548,tumor necrosis factor- α  ( P  = .027) and nuclear factor- κβ  ( P  = .059).,"[{'ForeName': 'Camila Saran', 'Initials': 'CS', 'LastName': 'da Silva', 'Affiliation': 'ABC Medical University Center (FMABC), Department of Clinical Analyzes, Santo André, SP, Brazil.'}, {'ForeName': 'Camila Ribeiro de Arruda', 'Initials': 'CRA', 'LastName': 'Monteiro', 'Affiliation': 'ABC Medical University Center (FMABC), Department of Clinical Analyzes, Santo André, SP, Brazil.'}, {'ForeName': 'Guilherme Henrique Fagundes', 'Initials': 'GHF', 'LastName': 'da Silva', 'Affiliation': 'ABC Medical University Center (FMABC), Department of Clinical Analyzes, Santo André, SP, Brazil.'}, {'ForeName': 'Roseli Oselka Sacardo', 'Initials': 'ROS', 'LastName': 'Sarni', 'Affiliation': 'ABC Medical University Center (FMABC), Department of Clinical Analyzes, Santo André, SP, Brazil.'}, {'ForeName': 'Fabiola Isabel Suano', 'Initials': 'FIS', 'LastName': 'Souza', 'Affiliation': 'ABC Medical University Center (FMABC), Department of Clinical Analyzes, Santo André, SP, Brazil.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Feder', 'Affiliation': 'ABC Medical University Center (FMABC), Department of Clinical Analyzes, Santo André, SP, Brazil.'}, {'ForeName': 'Márcia Cristina Fernandes', 'Initials': 'MCF', 'LastName': 'Messias', 'Affiliation': 'Laboratory of Multidisciplinary Research, São Francisco University, USF, Bragança Paulista, SP, Brazil.'}, {'ForeName': 'Patrícia de Oliveira', 'Initials': 'PO', 'LastName': 'Carvalho', 'Affiliation': 'Laboratory of Multidisciplinary Research, São Francisco University, USF, Bragança Paulista, SP, Brazil.'}, {'ForeName': 'Rosana M', 'Initials': 'RM', 'LastName': 'Alberici', 'Affiliation': 'ThoMSon Mass Spectrometry Laboratory, Institute of Chemistry, University of Campinas, Campinas, SP, Brazil.'}, {'ForeName': 'Ildenize B S', 'Initials': 'IBS', 'LastName': 'Cunha', 'Affiliation': 'ThoMSon Mass Spectrometry Laboratory, Institute of Chemistry, University of Campinas, Campinas, SP, Brazil.'}, {'ForeName': 'Marcos N', 'Initials': 'MN', 'LastName': 'Eberlin', 'Affiliation': 'ThoMSon Mass Spectrometry Laboratory, Institute of Chemistry, University of Campinas, Campinas, SP, Brazil.'}, {'ForeName': 'Paulo César Pires', 'Initials': 'PCP', 'LastName': 'Rosa', 'Affiliation': 'University of Campinas, Department of Pharmaceutical Sciences, Unicamp, Campinas, SP, Brazil.'}, {'ForeName': 'Fernando Luiz Affonso', 'Initials': 'FLA', 'LastName': 'Fonseca', 'Affiliation': 'ABC Medical University Center (FMABC), Department of Clinical Analyzes, Santo André, SP, Brazil.'}]",Journal of medicinal food,['10.1089/jmf.2019.0055']
560,31928490,N-Oleoyl-Phosphatidyl-Ethanolamine and Epigallo Catechin-3-Gallate Mitigate Oxidative Stress in Overweight and Class I Obese People on a Low-Calorie Diet.,"Oxidative stress and lipid peroxidation are considered key factors linking obesity with its associated complications. Epigallo catechin-3-gallate (EGCG) and oleoylethanolamide, together with its phospholipid precursor  N -oleoyl-phosphatidylethanolamine (NOPE), are nutritional compounds that might improve the oxidative stress status of obese people. Unfortunately, the bioavailability of these compounds is low; however, the coadministration of NOPE with EGCG has been shown to ameliorate both the plasma availability of EGCG and the intestinal levels of NOPE in rats. This double-blind placebo-controlled study investigated the effects of 2 months' supplementation with EGCG complexed with NOPE, combined with moderate energy restriction, on plasma oxidative status of overweight and class I obese subjects. A total of 138 subjects (body mass index: 25-35 kg/m 2 ) were recruited and randomized into two groups: the first ( n  = 67) received caps of placebo and the second ( n  = 71) caps of an oily dispersion of EGCG complexed with NOPE for 2 months. Subjects' supplementation was combined with moderate energy restriction (-800 kcal/day). Plasma oxidative status was determined by measuring the levels of oxidized low-density lipoprotein (Ox-LDL), malondialdehyde and reactive oxygen metabolites, and by calculating the lag time and the slope of Cu-induced lipid peroxidation kinetics. In total 116 subjects (27 M/89 F) completed the supplementation period, 49 in the placebo group and 67 in the treated group. Treatment induced a similar significant weight reduction in the two groups. Moreover, we found the mean changes of Ox-LDL significantly lower and the mean changes of antioxidant capacity (lag time) significantly higher in NOPE-EGCG group than in placebo group (treatment effect mean difference: -3.15 UL,  P  < .044 and +5.37 min,  P  < .0347, respectively). EGCG plasma levels were detectable only after 2 months of NOPE-EGCG diet. The NOPE-EGCG integration to a low-energy diet seems, therefore, useful for ameliorating oxidative stress-related markers, which are concomitant causes of obesity-induced disorders.",2020,"Moreover, we found the mean changes of Ox-LDL significantly lower and the mean changes of antioxidant capacity (lag time) significantly higher in NOPE-EGCG group than in placebo group (treatment effect mean difference:","['138 subjects (body mass index: 25-35\u2009kg/m 2 ', 'Overweight and Class', 'I obese subjects', 'obese people', 'I Obese People on a Low-Calorie Diet', 'In total 116 subjects (27\u2009M/89 F) completed the supplementation period, 49 in the placebo group and 67 in the treated group']","['N-Oleoyl-Phosphatidyl-Ethanolamine and Epigallo Catechin-3-Gallate', 'Epigallo catechin-3-gallate', 'placebo', 'EGCG complexed with NOPE, combined with moderate energy restriction', 'EGCG) and oleoylethanolamide, together with its phospholipid precursor  N -oleoyl-phosphatidylethanolamine (NOPE', 'caps of placebo and the second ( n \u2009=\u200971) caps of an oily dispersion of EGCG complexed with NOPE', 'NOPE-EGCG', 'EGCG']","['plasma oxidative status of overweight and class', 'EGCG plasma levels', 'Plasma oxidative status', 'mean changes of Ox-LDL', 'antioxidant capacity', 'weight reduction', 'levels of oxidized low-density lipoprotein (Ox-LDL), malondialdehyde and reactive oxygen metabolites, and by calculating the lag time and the slope of Cu-induced lipid peroxidation kinetics']","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C2930544', 'cui_str': 'Low-Calorie Diet'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517541', 'cui_str': '116 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C0031618', 'cui_str': 'Phosphatidylethanolamines'}, {'cui': 'C0007404', 'cui_str': 'Catechin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C1454896', 'cui_str': 'oleoylethanolamide'}, {'cui': 'C0179586', 'cui_str': 'Cap (physical object)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0332624', 'cui_str': 'Dispersion'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0348035', 'cui_str': 'oxidized low density lipoprotein'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0205332', 'cui_str': 'Reactive (qualifier value)'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0444686', 'cui_str': 'Calculated (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0023775', 'cui_str': 'Lipid Peroxidation'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}]",116.0,0.0603145,"Moreover, we found the mean changes of Ox-LDL significantly lower and the mean changes of antioxidant capacity (lag time) significantly higher in NOPE-EGCG group than in placebo group (treatment effect mean difference:","[{'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Cazzola', 'Affiliation': 'Department of Clinical and Biomedical Sciences ""L. Sacco,"" University of Milan, Milan, Italy.'}, {'ForeName': 'Mariangela', 'Initials': 'M', 'LastName': 'Rondanelli', 'Affiliation': 'IRCCS Mondino Foundation, Pavia, Italy.'}]",Journal of medicinal food,['10.1089/jmf.2019.0145']
561,32182336,Health Warnings and Beverage Purchase Behavior: Mediators of Impact.,"BACKGROUND


To reduce diet-related chronic disease, policymakers have proposed requiring health warnings on sugar-sweetened beverages (SSBs). Health warnings reduced purchases of these products by 22% in our recent randomized controlled trial, but the mechanisms remain unclear.
PURPOSE


We sought to identify the psychological mechanisms that explain why SSB health warnings affect purchase behavior.
METHODS


In 2018, we recruited 400 adult SSB consumers to complete a shopping task in a naturalistic convenience store laboratory in North Carolina, USA. We randomly assigned participants to either a health warning arm (all SSBs in the store displayed a text health warning) or to a control arm (SSBs displayed a control label). Participants selected items to purchase with cash.
RESULTS


Compared to control labels, health warnings elicited more attention, negative affect, anticipated social interactions, and thinking about harms (range of ds = 0.63-1.34; all p < .001). Health warnings also led to higher injunctive norms about limiting SSB consumption (d = 0.27, p = .008). Except for attention, all of these constructs mediated the effect of health warnings on SSB purchases (all p < .05). In contrast, health warnings did not influence other attitudes or beliefs about SSBs or SSB consumption (e.g., healthfulness, outcome expectations, and response efficacy).
CONCLUSIONS


Health warnings on sugar-sweetened beverages affected purchase behavior by eliciting negative emotions, increasing anticipated social interactions, keeping SSBs' harms at top of mind, and shifting norms about beverage consumption. Results are consistent with recent studies of why tobacco warnings influence quitting behavior, pointing toward a general framework for understanding how health warnings affect behavior.
CLINICAL TRIALS REGISTRATION


NCT #03511937.",2020,"Compared to control labels, health warnings elicited more attention, negative affect, anticipated social interactions, and thinking about harms (range of ds = 0.63-1.34; all p < .001).","['Participants selected items to purchase with cash', '400 adult SSB consumers to complete a shopping task in a naturalistic convenience store laboratory in North Carolina, USA']",['health warning arm (all SSBs in the store displayed a text health warning) or to a control arm (SSBs displayed a control label'],"['attitudes or beliefs about SSBs or SSB consumption (e.g., healthfulness, outcome expectations, and response efficacy']","[{'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0150768', 'cui_str': 'Shopping (observable entity)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0028407', 'cui_str': 'North Carolina'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C3541382', 'cui_str': 'Text'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}]",400.0,0.0604292,"Compared to control labels, health warnings elicited more attention, negative affect, anticipated social interactions, and thinking about harms (range of ds = 0.63-1.34; all p < .001).","[{'ForeName': 'Anna H', 'Initials': 'AH', 'LastName': 'Grummon', 'Affiliation': 'Harvard Center for Population and Development Studies, Harvard T. H. Chan School of Public Health, Cambridge, MA, USA.'}, {'ForeName': 'Noel T', 'Initials': 'NT', 'LastName': 'Brewer', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1093/abm/kaaa011']
562,32178950,A Randomized Prospective Placebo-Controlled Study of the Effects of Lavender Aromatherapy on Preoperative Anxiety in Cataract Surgery Patients.,"PURPOSE


To determine if lavender aromatherapy can reduce preoperative anxiety in cataract surgery patients.
DESIGN


Single-center prospective randomized placebo-controlled trial.
METHODS


Seventy-five patients awaiting cataract surgery were randomized to lavender essential oil or grape seed oil (control) and administered the State-Trait Anxiety Inventory. Vital signs were also recorded.
FINDINGS


Patients in the lavender group showed greater improvements in self-reported anxiety using the State-Trait Anxiety Inventory (P = .023, two-sample t test). Compared with the control group, the effects of lavender on the reduction of anxiety were statistically significant when adjusting for age, gender, and baseline scores (P = .012, analysis of covariance).
CONCLUSIONS


Lavender aromatherapy reduced anxiety in preoperative cataract surgery patients.",2020,"Compared with the control group, the effects of lavender on the reduction of anxiety were statistically significant when adjusting for age, gender, and baseline scores (P = .012, analysis of covariance).
","['preoperative cataract surgery patients', 'cataract surgery patients', 'Seventy-five patients awaiting cataract surgery', 'Cataract Surgery Patients']","['lavender essential oil or grape seed oil (control) and administered the State-Trait Anxiety Inventory', 'Lavender Aromatherapy', 'lavender aromatherapy', 'placebo', 'Lavender aromatherapy', 'Placebo']","['reduction of anxiety', 'anxiety', 'self-reported anxiety using the State-Trait Anxiety Inventory', 'Preoperative Anxiety', 'preoperative anxiety']","[{'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319621', 'cui_str': 'Seventy-five'}]","[{'cui': 'C0028910', 'cui_str': 'Oils, Essential'}, {'cui': 'C0458160', 'cui_str': 'grape seed oil'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0524903', 'cui_str': 'Lavender'}, {'cui': 'C0376547', 'cui_str': 'Therapy, Aroma'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}]",75.0,0.0589282,"Compared with the control group, the effects of lavender on the reduction of anxiety were statistically significant when adjusting for age, gender, and baseline scores (P = .012, analysis of covariance).
","[{'ForeName': 'Philip Francis', 'Initials': 'PF', 'LastName': 'Stanley', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, Khoo Teck Puat Hospital, Singapore. Electronic address: philip.stanley@ktph.com.sg.'}, {'ForeName': 'Lai Foon', 'Initials': 'LF', 'LastName': 'Wan', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, Khoo Teck Puat Hospital, Singapore.'}, {'ForeName': 'Rostihar Abdul', 'Initials': 'RA', 'LastName': 'Karim', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, Khoo Teck Puat Hospital, Singapore.'}]",Journal of perianesthesia nursing : official journal of the American Society of PeriAnesthesia Nurses,['10.1016/j.jopan.2019.12.004']
563,32164612,Experiences and intentions of Ugandan household tuberculosis contacts receiving test results via text message: an exploratory study.,"BACKGROUND


The World Health Organization (WHO) recommends household contact investigation for tuberculosis (TB) in high-burden countries. However, household contacts who complete evaluation for TB during contact investigation may have difficulty accessing their test results. Use of automated short-messaging services (SMS) to deliver test results could improve TB status awareness and linkage to care. We sought to explore how household contacts experience test results delivered via SMS, and how these experiences influence follow-up intentions.
METHODS


We conducted semi-structured interviews with household contacts who participated in a randomized controlled trial evaluating home sputum collection and delivery of TB results via SMS (Pan-African Clinical Trials Registry #201509000877140). We asked about feelings, beliefs, decisions, and behaviors in response to the SMS results. We analyzed the content and emerging themes in relation to the Theory of Planned Behavior.
RESULTS


We interviewed and achieved thematic saturation with ten household contacts. Nine received TB-negative results and one a TB-positive result. Household contacts reported relief upon receiving SMS confirming their TB status, but also said they lacked confidence in the results delivered by SMS. Some worried that negative results were incorrect until they spoke to a lay health worker (LHW). Household contacts said their long-term intentions to request help or seek care were influenced by perceived consequences of not observing the LHW's instructions related to the SMS and follow-up procedures; beliefs about the curability of TB; anticipated support from LHWs; and perceived barriers to responding to an SMS request for further evaluation.
CONCLUSION


Household contacts experienced relief when they received results. However, they were less confident about results delivered via SMS than results delivered by LHWs. Delivery of results by SMS should complement continued interaction with LHWs, not replace them.",2020,Use of automated short-messaging services (SMS) to deliver test results could improve TB status awareness and linkage to care.,[],['automated short-messaging services (SMS'],['TB status awareness and linkage to care'],[],"[{'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}]","[{'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}]",,0.101313,Use of automated short-messaging services (SMS) to deliver test results could improve TB status awareness and linkage to care.,"[{'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Ggita', 'Affiliation': 'Uganda Tuberculosis Implementation Research Consortium, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Katahoire', 'Affiliation': 'Child Health and Development Centre, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Amanda J', 'Initials': 'AJ', 'LastName': 'Meyer', 'Affiliation': 'Uganda Tuberculosis Implementation Research Consortium, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Nansubuga', 'Affiliation': 'Department of Population Studies, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Talemwa', 'Initials': 'T', 'LastName': 'Nalugwa', 'Affiliation': 'Uganda Tuberculosis Implementation Research Consortium, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Turimumahoro', 'Affiliation': 'Uganda Tuberculosis Implementation Research Consortium, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Ochom', 'Affiliation': 'Uganda Tuberculosis Implementation Research Consortium, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Ayakaka', 'Affiliation': 'Uganda Tuberculosis Implementation Research Consortium, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Jessica E', 'Initials': 'JE', 'LastName': 'Haberer', 'Affiliation': 'Department of Medicine, Massachusetts General Hospital Global Health, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Achilles', 'Initials': 'A', 'LastName': 'Katamba', 'Affiliation': 'Uganda Tuberculosis Implementation Research Consortium, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Armstrong-Hough', 'Affiliation': 'Uganda Tuberculosis Implementation Research Consortium, Makerere University, Kampala, Uganda. mah842@nyu.edu.'}, {'ForeName': 'J Lucian', 'Initials': 'JL', 'LastName': 'Davis', 'Affiliation': 'Uganda Tuberculosis Implementation Research Consortium, Makerere University, Kampala, Uganda.'}]",BMC public health,['10.1186/s12889-020-8427-0']
564,31953596,Safety of air tamponade versus corneal hydration for sealing clear corneal incisions in cataract surgery.,"PURPOSE


To compare safety of wound hydration to anterior chamber air tamponade for securing watertight closure of clear corneal incisions, during uneventful cataract surgery.
METHODS


Prospective, comparative case-control series. Patients undergoing phacoemulsification were assigned to receive either anterior chamber air bubble (Group A) or intrastromal wound hydration with balanced salt solution (Group B) at the end of the procedure. Two high-volume surgeons operated equal number of cases in each group employing identical surgical technique, except for corneal side incision management. Patients were assessed pre- and postoperatively at day 1, day 4, day 9, and day 30 after surgery.
RESULTS


One hundred eyes of 100 patients were enrolled, of which 2 were lost to follow-up. The two groups were comparable in terms of preoperative risk factor assessment, baseline central corneal thickness (CCT), preoperative endothelial cell density, as well as cumulative dissipated energy and duration of phacoemulsification (p > 0.05). Mean CCT and best-corrected visual acuity were better in Group B on the first postoperative day, but did not differ between the two groups at all other timepoints. Surgically induced astigmatism was comparable in the two groups (p > 0.05). Endothelial cell density loss at 1 month postoperatively was greater in Group A (34.06%) compared to Group B (16.45%).
CONCLUSIONS


Wound sealing with intrastromal hydration proved to be safer than air tamponade in terms of preserving endothelial cell density and function.",2020,"Endothelial cell density loss at 1 month postoperatively was greater in Group A (34.06%) compared to Group B (16.45%).
","['Patients undergoing phacoemulsification', 'One hundred eyes of 100 patients were enrolled, of which 2 were lost to follow-up', 'cataract surgery']","['air tamponade versus corneal hydration', 'wound hydration to anterior chamber air tamponade', 'anterior chamber air bubble (Group A) or intrastromal wound hydration with balanced salt solution']","['Endothelial cell density loss', 'Surgically induced astigmatism', 'preoperative risk factor assessment, baseline central corneal thickness (CCT), preoperative endothelial cell density, as well as cumulative dissipated energy and duration of phacoemulsification', 'Mean CCT and best-corrected visual acuity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2193446', 'cui_str': 'Phacoemulsification'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C1302313', 'cui_str': 'Lost to Follow-Up'}, {'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}]","[{'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0579016', 'cui_str': 'Tamponade - action (qualifier value)'}, {'cui': 'C1321013', 'cui_str': 'Hydration'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0003151', 'cui_str': 'Anterior Chamber'}, {'cui': 'C0001863', 'cui_str': 'Air bubble (substance)'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C3653289', 'cui_str': 'Salt irrigating solutions'}]","[{'cui': 'C0429518', 'cui_str': 'Endothelial cell count'}, {'cui': 'C1689961', 'cui_str': 'Surgically induced astigmatism'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1720164', 'cui_str': 'Central corneal thickness'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C2193446', 'cui_str': 'Phacoemulsification'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}]",100.0,0.0205119,"Endothelial cell density loss at 1 month postoperatively was greater in Group A (34.06%) compared to Group B (16.45%).
","[{'ForeName': 'Asimina', 'Initials': 'A', 'LastName': 'Mataftsi', 'Affiliation': 'Department of Ophthalmology, Aristotle University of Thessaloniki, 56403, Thessaloniki, Greece. amatafts@auth.gr.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Dermenoudi', 'Affiliation': 'Department of Ophthalmology, Aristotle University of Thessaloniki, 56403, Thessaloniki, Greece.'}, {'ForeName': 'Artemis', 'Initials': 'A', 'LastName': 'Matsou', 'Affiliation': 'Department of Ophthalmology, Aristotle University of Thessaloniki, 56403, Thessaloniki, Greece.'}, {'ForeName': 'Argyrios', 'Initials': 'A', 'LastName': 'Tzamalis', 'Affiliation': 'Department of Ophthalmology, Aristotle University of Thessaloniki, 56403, Thessaloniki, Greece.'}, {'ForeName': 'Periklis', 'Initials': 'P', 'LastName': 'Brazitikos', 'Affiliation': 'Department of Ophthalmology, Aristotle University of Thessaloniki, 56403, Thessaloniki, Greece.'}, {'ForeName': 'Persefoni', 'Initials': 'P', 'LastName': 'Talimtzi', 'Affiliation': 'Department of Hygiene, Social-Preventive Medicine and Medical Statistics, School of Medicine, Faculty of Health Sciences, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Ziakas', 'Affiliation': 'Department of Ophthalmology, Aristotle University of Thessaloniki, 56403, Thessaloniki, Greece.'}, {'ForeName': 'Ioannis T', 'Initials': 'IT', 'LastName': 'Tsinopoulos', 'Affiliation': 'Department of Ophthalmology, Aristotle University of Thessaloniki, 56403, Thessaloniki, Greece.'}]",Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie,['10.1007/s00417-020-04602-1']
565,31722941,"Effect of high-dose vitamin D3 on 28-day mortality in adult critically ill patients with severe vitamin D deficiency: a study protocol of a multicentre, placebo-controlled double-blind phase III RCT (the VITDALIZE study).","INTRODUCTION


Observational studies have demonstrated an association between vitamin D deficiency and increased risk of morbidity and mortality in critically ill patients. Cohort studies and pilot trials have suggested promising beneficial effects of vitamin D replacement in the critical ill, at least in patients with severe vitamin D deficiency. As vitamin D is a simple, low-cost and safe intervention, it has potential to improve survival in critically ill patients.
METHODS AND ANALYSIS


In this randomised, placebo-controlled, double-blind, multicentre, international trial, 2400 adult patients with severe vitamin D deficiency (25-hydroxyvitamin D≤12 ng/mL) will be randomised in a 1:1 ratio by www.randomizer.at to receive a loading dose of 540 000 IU cholecalciferol within 72 hours after intensive care unit (ICU) admission, followed by 4000 IU daily for 90 days or placebo. Hypercalcaemia may occur as a side effect, but is monitored by regular checks of the calcium level. The primary outcome is all-cause mortality at 28 days after randomisation. Secondary outcomes are: ICU, hospital, 90-day and 1-year mortality; hospital and ICU length of stay, change in organ dysfunction on day 5 as measured by Sequential Organ Function Assessment (SOFA) score, number of organ failures; hospital and ICU readmission until day 90; discharge destination, self-reported infections requiring antibiotics until day 90 and health-related quality of life. Recruitment status is ongoing.
ETHICS AND DISSEMINATION


National ethical approval was obtained by the Ethics Committee of the University of Graz for Austria, Erasme University Brussels (Belgium) and University Hospital Frankfurt (Germany), and will further be gained according to individual national processes. On completion, results will be published in a peer-reviewed scientific journal. The study findings will be presented at national and international meetings with abstracts online.
TRIAL REGISTRATION


NCT03188796, EudraCT-No: 2016-002460-13.",2019,"As vitamin D is a simple, low-cost and safe intervention, it has potential to improve survival in critically ill patients.
","['2400 adult patients with severe vitamin D deficiency (25-hydroxyvitamin D≤12\u2009ng/mL', 'critically ill patients', 'patients with severe vitamin D deficiency', 'adult critically ill patients with severe vitamin D deficiency']","['high-dose vitamin D3', 'www.randomizer.at', 'placebo', 'cholecalciferol', 'vitamin D replacement', 'vitamin D']","['ICU, hospital, 90-day and 1-year mortality; hospital and ICU length of stay, change in organ dysfunction on day 5 as measured by Sequential Organ Function Assessment (SOFA', 'score, number of organ failures; hospital and ICU readmission until day 90; discharge destination, self-reported infections requiring antibiotics until day 90 and health-related quality of life', 'cause mortality', '28-day mortality']","[{'cui': 'C4517656', 'cui_str': 'Two thousand four hundred'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D Deficiency'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0010340', 'cui_str': 'Critically Ill'}]","[{'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C3265062', 'cui_str': 'vitamin D3'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0242215', 'cui_str': 'Cholecalciferols'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}]","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0349410', 'cui_str': 'Single organ dysfunction (disorder)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}]",2400.0,0.759845,"As vitamin D is a simple, low-cost and safe intervention, it has potential to improve survival in critically ill patients.
","[{'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Amrein', 'Affiliation': 'Department of Internal Medicine, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Dhruv', 'Initials': 'D', 'LastName': 'Parekh', 'Affiliation': 'Birmingham Acute Care Research Group, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Westphal', 'Affiliation': 'Department of Anesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital Frankfurt, Goethe University, Frankfurt, Germany.'}, {'ForeName': 'Jean-Charles', 'Initials': 'JC', 'LastName': 'Preiser', 'Affiliation': 'Intensive Care Medicine, Erasme University Hospital, Brussels, Belgium.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Berghold', 'Affiliation': 'Institute for Medical Informatics, Statstics, and Documentation, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Regina', 'Initials': 'R', 'LastName': 'Riedl', 'Affiliation': 'Institute for Medical Informatics, Statstics, and Documentation, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Eller', 'Affiliation': 'Intensive Care Unit, Department of Internal Medicine, University Hospital of Graz, Graz, Austria.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Schellongowski', 'Affiliation': 'University Hospital of Internal Medicine I, Medical University Wien, Wien, Austria.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Thickett', 'Affiliation': 'Birmingham Acute Care Research Group, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Meybohm', 'Affiliation': 'Department of Anesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital Frankfurt, Goethe University, Frankfurt, Germany patrick.meybohm@kgu.de.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-031083']
566,31060104,Effects of intranasal administration of violet oil in dry eye disease.,"BACKGROUND


Dry eye disease is a disorder of the tear film. In this study, the effect of Viola odorata L. oily extract was examined for the treatment of patients suffering from dry eye disease.
METHODS


A randomised, double-blind, placebo-controlled study was designed. During the trial, Schirmer's test, tear breakup time, Oxford staining and the Ocular Surface Disease Index were assessed. Overall, 105 patients with dry eye symptoms between the ages of 18 and 60 years were allocated to the violet-almond oil, almond oil and placebo (1% w/v hydroxypropyl methylcellulose solution) groups. The treatment and placebo were administered intranasally, two drops three times a day for one month. The patients were followed up for four weeks. A total of 91 patients (32, 29 and 30 in the violet-almond oil, almond oil and placebo groups, respectively) completed the study.
RESULTS


At baseline, there was no difference between the three groups in terms of demographic data and the measurement parameters. After the intervention, the results revealed that the Schirmer's score without local anaesthesia and the tear breakup time results significantly improved in the violet-almond oil group. One-way ANOVA indicated a significant improvement in the Schirmer's score, tear breakup time and Ocular Surface Disease Index of the treatment group, as compared with the other groups (p < 0.05). However, the obtained results did not present any significant mean difference between and within the groups of the Oxford staining grade (p > 0.05).
CONCLUSIONS


This trial showed that the intranasally administered V. odorata L. oily extract enhances tear production and improves tear film stability.",2019,"One-way ANOVA indicated a significant improvement in the Schirmer's score, tear breakup time and Ocular Surface Disease Index of the treatment group, as compared with the other groups (p < 0.05).","['91 patients (32, 29 and 30 in the', 'dry eye disease', 'patients suffering from dry eye disease', 'groups, respectively) completed the study', '105 patients with dry eye symptoms between the ages of 18 and 60\u2009years']","['placebo', 'violet oil', 'Viola odorata L. oily extract', 'violet-almond oil, almond oil and placebo', 'V. odorata L. oily extract']","['tear breakup time, Oxford staining and the Ocular Surface Disease Index', 'tear breakup time results', ""Schirmer's score, tear breakup time and Ocular Surface Disease Index"", 'tear production and improves tear film stability']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0314719', 'cui_str': 'Dry eyes (finding)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0330463', 'cui_str': 'Violet'}, {'cui': 'C0028908', 'cui_str': 'Oils'}, {'cui': 'C0330464', 'cui_str': 'Viola odorata (organism)'}, {'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}, {'cui': 'C0102271', 'cui_str': 'almond oil'}]","[{'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0487602', 'cui_str': 'Staining'}, {'cui': 'C1557335', 'cui_str': 'Ocular surface disease'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2363241', 'cui_str': 'Tear production, function (observable entity)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C4319646', 'cui_str': 'Film'}]",105.0,0.0654843,"One-way ANOVA indicated a significant improvement in the Schirmer's score, tear breakup time and Ocular Surface Disease Index of the treatment group, as compared with the other groups (p < 0.05).","[{'ForeName': 'Aniseh', 'Initials': 'A', 'LastName': 'Saffar Shahroodi', 'Affiliation': 'Department of Traditional Persian Medicine, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mahmood', 'Initials': 'M', 'LastName': 'Nejabat', 'Affiliation': 'Poostchi Ophthalmology Research Centre, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Nimrouzi', 'Affiliation': 'Department of Traditional Persian Medicine, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Aghaei', 'Affiliation': 'Eye Research Center, Rassoul Akram Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Salehi', 'Affiliation': 'Research Center for Traditional Medicine and History of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Rezaei Mokarram', 'Affiliation': 'Department of Biology, Razi Vaccine and Serum Research Institute, Agricultural Research, Education and Extension Organization (AREEO), Karaj, Iran.'}]",Clinical & experimental optometry,['10.1111/cxo.12910']
567,31567597,Pilot Study of an Integrated Smartphone and Breathalyzer Contingency Management Intervention for Alcohol Use.,"INTRODUCTION


Monitoring devices provide a platform for assessing alcohol use and implementing alcohol interventions. This pilot study focused on assessing the early-stage feasibility and usability of a smartphone-based application and breathalyzer used in a contingency management intervention for alcohol use.
METHODS


Six nontreatment-seeking participants completed a 9-week ABA within-subjects designed intervention targeting alcohol use. Participants submitted 2 to 8 alcohol breathalyzer samples per day and completed self-report drinking measures and usability assessments. During the A phases (weeks 1-3 and 8-9), participants received reinforces for submitting breathalyzer samples, regardless of their results. During the contingency management, B phase (weeks 4-7), and received reinforcers only when negative breathalyzer samples were submitted. Usability assessment of the application was also conducted during weeks 2 and 9.
RESULTS


Participants in the contingent B phase (49%) were more likely to submit alcohol-negative breathalyzer samples compared with the noncontingent A phases (27%; P < 0.001). Usability assessment of the application varied, and participants noted several technical concerns.
CONCLUSION


The use of smartphones and breathalyzers may be a practical solution to extend the reach of contingency management during and after treatment.",2020,"RESULTS


Participants in the contingent B phase (49%) were more likely to submit alcohol-negative breathalyzer samples compared with the noncontingent A phases (27%; P < 0.001).",['Six nontreatment-seeking participants completed a 9-week ABA within-subjects designed intervention targeting alcohol use'],"['smartphone-based application and breathalyzer', 'Integrated Smartphone and Breathalyzer Contingency Management Intervention']",[],"[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}]",[],,0.0178718,"RESULTS


Participants in the contingent B phase (49%) were more likely to submit alcohol-negative breathalyzer samples compared with the noncontingent A phases (27%; P < 0.001).","[{'ForeName': 'Oladunni', 'Initials': 'O', 'LastName': 'Oluwoye', 'Affiliation': 'Initiative for Research and Education to Advance Community Health, Washington State University, Spokane, WA (OO, HR, JH, KCA, MGM); Elson S. Floyd College of Medicine, Washington State University, Spokane, WA (OO, SM, JR, MGM); Program for Excellence in Addiction Research, Washington State University, Spokane, WA (OO, SM, JR, MGM); Providence Medical Research Center, Providence Health Care, Spokane, WA (SM).'}, {'ForeName': 'Hailey', 'Initials': 'H', 'LastName': 'Reneau', 'Affiliation': ''}, {'ForeName': 'Jalene', 'Initials': 'J', 'LastName': 'Herron', 'Affiliation': ''}, {'ForeName': 'Karl C', 'Initials': 'KC', 'LastName': 'Alcover', 'Affiliation': ''}, {'ForeName': 'Sterling', 'Initials': 'S', 'LastName': 'McPherson', 'Affiliation': ''}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Roll', 'Affiliation': ''}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'McDonell', 'Affiliation': ''}]",Journal of addiction medicine,['10.1097/ADM.0000000000000553']
568,32019158,Lactobacillus acidophilus  DDS-1 and  Bifidobacterium lactis  UABla-12 Improve Abdominal Pain Severity and Symptomology in Irritable Bowel Syndrome: Randomized Controlled Trial.,"This randomized, double-blind, placebo-controlled, multi-center study investigated the clinical efficacy of two probiotic strains on abdominal pain severity and symptomology in irritable bowel syndrome (IBS). Three hundred and thirty adults, aged 18 to 70 years, with IBS according to Rome IV criteria were allocated (1:1:1) to receive placebo,  L actobacillus   acidophilus  DDS-1 (1 × 10 10  CFU/day) or  B ifidobacterium   animalis  subsp.  lactis  UABla-12 (1 × 10 10  CFU/day) over six weeks. The primary outcome was the change in Abdominal Pain Severity - Numeric Rating Scale (APS-NRS). Over the intervention period, APS-NRS was significantly improved in both probiotic groups vs. placebo in absolute terms (DDS-1: -2.59 ± 2.07, p = 0.001; UABla-12: -1.56 ± 1.83, p = 0.001) and in percentage of significant responders (DDS-1: 52.3%, p < 0.001); UABla-12 (28.2%, p = 0.031). Significant amelioration vs. placebo was observed in IBS Symptom Severity Scale (IBS-SSS) scores for L. acidophilus DDS-1 (-133.4 ± 95.19, p < 0.001) and B. lactis UABla-12 (-104.5 ± 96.08, p < 0.001) groups, including sub-scores related to abdominal pain, abdominal distension, bowel habits and quality of life. Additionally, a significant normalization was observed in stool consistency in both probiotic groups over time and as compared to placebo. In conclusion, L. acidophilus DDS-1 and B. lactis UABla-12 improved abdominal pain and symptom severity scores with a corresponding normalization of bowel habits in adults with IBS.",2020,"Significant amelioration vs. placebo was observed in IBS Symptom Severity Scale (IBS-SSS) scores for L. acidophilus DDS-1 (-133.4 ± 95.19, p < 0.001) and B. lactis UABla-12 (-104.5 ± 96.08, p < 0.001) groups, including sub-scores related to abdominal pain, abdominal distension, bowel habits and quality of life.","['Three hundred and thirty adults, aged 18 to 70 years, with IBS according to Rome IV criteria', 'irritable bowel syndrome (IBS', 'adults with IBS', 'Irritable Bowel Syndrome']","['probiotic strains', 'UABla-12', 'placebo', 'placebo,  L actobacillus   acidophilus  DDS-1 (1 × 10 10  CFU/day) or  B ifidobacterium   animalis  subsp']","['abdominal pain and symptom severity scores', 'IBS Symptom Severity Scale (IBS-SSS) scores', 'Abdominal Pain Severity and Symptomology', 'abdominal pain severity and symptomology', 'abdominal pain, abdominal distension, bowel habits and quality of life', 'APS-NRS', 'stool consistency', 'change in Abdominal Pain Severity - Numeric Rating Scale (APS-NRS']","[{'cui': 'C4517719', 'cui_str': '330 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0022104', 'cui_str': 'Irritable Bowel Syndrome'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0000737', 'cui_str': 'Abdominal Pain'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0000731', 'cui_str': 'Swollen abdomen (finding)'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0034380'}, {'cui': 'C0085409', 'cui_str': 'Polyendocrinopathies, Autoimmune'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0332529', 'cui_str': 'Consistency finding'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",330.0,0.342517,"Significant amelioration vs. placebo was observed in IBS Symptom Severity Scale (IBS-SSS) scores for L. acidophilus DDS-1 (-133.4 ± 95.19, p < 0.001) and B. lactis UABla-12 (-104.5 ± 96.08, p < 0.001) groups, including sub-scores related to abdominal pain, abdominal distension, bowel habits and quality of life.","[{'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Martoni', 'Affiliation': 'UAS Laboratories LLC, 4375 Duraform Lane, Windsor, WI 53598, USA.'}, {'ForeName': 'Shalini', 'Initials': 'S', 'LastName': 'Srivastava', 'Affiliation': 'Vedic Lifesciences, 203 Morya Landmark1, New Link Road, Andheri W, Mumbai 400053, India.'}, {'ForeName': 'Gregory J', 'Initials': 'GJ', 'LastName': 'Leyer', 'Affiliation': 'UAS Laboratories LLC, 4375 Duraform Lane, Windsor, WI 53598, USA.'}]",Nutrients,['10.3390/nu12020363']
569,32019783,A Randomized Trial of Empagliflozin to Increase Plasma Sodium Levels in Patients with the Syndrome of Inappropriate Antidiuresis.,"BACKGROUND


Treatment options to address the hyponatremia induced by the syndrome of inappropriate antidiuresis (SIAD) are inadequate. The sodium glucose cotransporter 2 (SGLT2) inhibitor empagliflozin promotes osmotic diuresis  via  urinary glucose excretion and therefore, might offer a novel treatment option for SIAD.
METHODS


In this double-blind, randomized trial, we recruited 88 hospitalized patients with SIAD-induced hyponatremia <130 mmol/L at the University Hospital Basel from September 2016 until January 2019 and assigned patients to receive, in addition to standard fluid restriction of <1000 ml/24 h, a once-daily dose of oral empagliflozin or placebo for 4 days. The primary end point was the absolute change in plasma sodium concentration after 4 days of treatment. Secondary end points included predisposing factors for treatment response and safety of the intervention.
RESULTS


Of the 87 patients who completed the trial, 43 (49%) received treatment with empagliflozin, and 44 (51%) received placebo. Baseline plasma sodium concentrations were similar for the two groups (median 125.5 mmol/L for the empaflozin group and median 126 mmol/L for the placebo group). Patients treated with empagliflozin had a significantly higher increase of median plasma sodium concentration compared with those receiving placebo (10 versus 7 mmol/L, respectively;  P =0.04). Profound hyponatremia (<125 mmol/L) and lower baseline osmolality levels increased the likelihood of response to treatment with empagliflozin. Treatment was well tolerated, and no events of hypoglycemia or hypotension occurred among those receiving empagliflozin.
CONCLUSIONS


Among hospitalized patients with SIAD treated with fluid restriction, those who received empagliflozin had a larger increase in plasma sodium levels compared with those who received placebo. This finding indicates that empagliflozin warrants further study as a treatment for the disorder.",2020,"Patients treated with empagliflozin had a significantly higher increase of median plasma sodium concentration compared with those receiving placebo (10 versus 7 mmol/L, respectively;  P =0.04).","['87 patients who completed the trial, 43 (49%) received treatment with', 'Patients with the Syndrome of Inappropriate Antidiuresis', 'hospitalized patients with SIAD treated with fluid restriction', '88 hospitalized patients with SIAD-induced hyponatremia <130 mmol/L at the University Hospital Basel from September 2016 until January 2019 and assigned patients']","['oral empagliflozin or placebo', 'empaflozin', 'empagliflozin', 'Empagliflozin', 'sodium glucose cotransporter 2 (SGLT2) inhibitor empagliflozin', 'placebo']","['Profound hyponatremia', 'Plasma Sodium Levels', 'absolute change in plasma sodium concentration', 'tolerated, and no events of hypoglycemia or hypotension', 'median plasma sodium concentration', 'predisposing factors for treatment response and safety of the intervention', 'Baseline plasma sodium concentrations', 'plasma sodium levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0021141', 'cui_str': 'Syndrome of Inappropriate ADH (SIADH) Secretion'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0204700', 'cui_str': 'Fluid restriction (procedure)'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0020625', 'cui_str': 'Hyponatremia'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C1532563', 'cui_str': 'umol/mL'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0017739', 'cui_str': 'Sodium-Glucose Transport Proteins'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0439808', 'cui_str': 'Profundis'}, {'cui': 'C0020625', 'cui_str': 'Hyponatremia'}, {'cui': 'C1272109', 'cui_str': 'Plasma sodium measurement'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0858175', 'cui_str': 'Plasma sodium'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0032946', 'cui_str': 'Predisposing Factors'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",88.0,0.324692,"Patients treated with empagliflozin had a significantly higher increase of median plasma sodium concentration compared with those receiving placebo (10 versus 7 mmol/L, respectively;  P =0.04).","[{'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Refardt', 'Affiliation': 'Department of Endocrinology, Diabetology and Metabolism, University Hospital Basel, Basel, Switzerland; julie.refardt@usb.ch.'}, {'ForeName': 'Cornelia', 'Initials': 'C', 'LastName': 'Imber', 'Affiliation': 'Department of Endocrinology, Diabetology and Metabolism, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Clara O', 'Initials': 'CO', 'LastName': 'Sailer', 'Affiliation': 'Department of Endocrinology, Diabetology and Metabolism, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Nica', 'Initials': 'N', 'LastName': 'Jeanloz', 'Affiliation': 'Department of Endocrinology, Diabetology and Metabolism, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Potasso', 'Affiliation': 'Department of Endocrinology, Diabetology and Metabolism, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Kutz', 'Affiliation': 'Department of Endocrinology, Diabetology and Metabolism, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Widmer', 'Affiliation': 'Department of Endocrinology, Diabetology and Metabolism, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Sandrine A', 'Initials': 'SA', 'LastName': 'Urwyler', 'Affiliation': 'Department of Endocrinology, Diabetology and Metabolism, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Fahim', 'Initials': 'F', 'LastName': 'Ebrahimi', 'Affiliation': 'Department of Endocrinology, Diabetology and Metabolism, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Deborah R', 'Initials': 'DR', 'LastName': 'Vogt', 'Affiliation': 'Clinical Trial Unit, Department of Clinical Research, University of Basel and University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Winzeler', 'Affiliation': 'Department of Endocrinology, Diabetology and Metabolism, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Mirjam', 'Initials': 'M', 'LastName': 'Christ-Crain', 'Affiliation': 'Department of Endocrinology, Diabetology and Metabolism, University Hospital Basel, Basel, Switzerland.'}]",Journal of the American Society of Nephrology : JASN,['10.1681/ASN.2019090944']
570,31985467,Safety and Efficacy of Donepezil 10 mg/day in Patients with Mild to Moderate Alzheimer's Disease.,"BACKGROUND


Efficacy and dose-effect relationship of donepezil for treating patients with Alzheimer's disease (AD) have been proven. However, few studies focused on the safety of donepezil, particularly in Chinese patients.
OBJECTIVE


To assess the safety of donepezil 10 mg/day in Chinese patients with mild-to-moderate AD.
METHODS


In this single-arm, prospective, multicenter trial, 241 patients with mild to moderate AD who had been treated with donepezil 5 mg/day for at least 4 weeks were enrolled. All patients received donepezil 10 mg/day for 20 weeks. Primary outcome was the incidence of adverse events (AEs). Safety profile was evaluated by physical examinations including vital signs and weight, clinical laboratory tests and electrocardiograms, and also correlation analysis between AEs and APOE genotypes.
RESULTS


241 patients were enrolled. Of which, 38.59% patients experienced at least one AE and 17.43% discontinued due to AEs. Most AEs were mild to moderate, with diarrhea, vomiting, and nausea the most frequently reported. Risk of AEs was significantly increased by concomitant use of drugs for cardiovascular and cerebrovascular diseases. Mean changes in heart rate and corrected QT relative to baseline were -1.08±6.02 beat/min (p = 0.009) and -3.91±18.68 ms (p = 0.0062) at week 4 and -1.48 beat/min±7.18 (p = 0.0028) and -0.66 ms±19.66 (p = 0.6561) at week 20, respectively. There were no significant changes in other vital sign parameters. Patients' MMSE scores improved significantly after treatment (p = 0.0038), especially for non-APOEɛ4 allele carriers and patients ≤75 years.
CONCLUSION


Donepezil 10 mg/day can be tolerated and is effective in Chinese patients with mild-to-moderate AD.",2020,"Patients' MMSE scores improved significantly after treatment (p = 0.0038), especially for non-APOEɛ4 allele carriers and patients ≤75 years.
","['Chinese patients', '241 patients with mild to moderate AD who had been treated with', 'Chinese patients with mild-to-moderate AD', '241 patients were enrolled', ""patients with Alzheimer's disease (AD"", ""Patients with Mild to Moderate Alzheimer's Disease"", '5\u200amg/day for at least 4 weeks were enrolled']","['Donepezil', 'donepezil']","['Safety and Efficacy', 'vital signs and weight, clinical laboratory tests and electrocardiograms', 'diarrhea, vomiting, and nausea', 'MMSE scores', 'heart rate and corrected QT relative', 'Risk of AEs', 'incidence of adverse events (AEs']","[{'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0527316', 'cui_str': 'donepezil'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0518766'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C4505474', 'cui_str': 'Clinical Laboratory Tests'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0451306', 'cui_str': 'Folstein Mini-Mental State Examination'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",241.0,0.139292,"Patients' MMSE scores improved significantly after treatment (p = 0.0038), especially for non-APOEɛ4 allele carriers and patients ≤75 years.
","[{'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Jia', 'Affiliation': 'Department of Neurology, Xuan Wu Hospital of Capital Medical University, Beijing, China.'}, {'ForeName': 'Cuibai', 'Initials': 'C', 'LastName': 'Wei', 'Affiliation': 'Department of Neurology, Xuan Wu Hospital of Capital Medical University, Beijing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'Department of Psychiatry, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang Province, China.'}, {'ForeName': 'Longfei', 'Initials': 'L', 'LastName': 'Jia', 'Affiliation': 'Department of Neurology, Xuan Wu Hospital of Capital Medical University, Beijing, China.'}, {'ForeName': 'Aihong', 'Initials': 'A', 'LastName': 'Zhou', 'Affiliation': 'Department of Neurology, Xuan Wu Hospital of Capital Medical University, Beijing, China.'}, {'ForeName': 'Fen', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Xuan Wu Hospital of Capital Medical University, Beijing, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Tang', 'Affiliation': 'Department of Neurology, Xuan Wu Hospital of Capital Medical University, Beijing, China.'}, {'ForeName': 'Luoyi', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': 'Department of Psychiatry, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang Province, China.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-190940']
571,32026729,The ability of CNS vital signs to detect coached sandbagging performance during concussion baseline testing: a randomized control trial.,"Objective : Despite widespread use of baseline neurocognitive testing in concussion management, suboptimal performance due to sandbagging still readily occurs without detection. The purpose of this study is to determine CNS Vital Signs validity indicator accuracy in detecting coached sandbagging compared to controls. Method : We compared rates of invalidity and domain composite scores for neurocognitive test performance between two groups of twenty-five college-aged students (age = 20.8 ± 1.1 years, range 18-25, 48% female) completing CNS Vital Signs instructed to either 1) give their best effort (control) or, 2) give suboptimal performance (sandbag). The sandbagging group was given standardized instructions on how to sandbag without detection. All participants rated their effort after completing on a Visual Analog Scale (0-100 mm). Results : Built in invalidity indicators successfully identified 68.0% of sandbaggers, while only 12% in the control group presented with invalid scores. Participants in the sandbagging group on average reported significantly lower effort (sandbag: 51.0 ± 21.0, control: 86.0 ± 12.0,  p  < .001) Conclusions : Built-in CNS Vital Signs validity indicators have an overall high accuracy in identifying those attempting to purposefully sandbag and are comparable to other computerized neurocognitive tests. Given that 32% of intentional sandbaggers went undetected, clinicians should consider additional safeguards to detect these individuals at baseline.",2020,Built-in CNS Vital Signs validity indicators have an overall high accuracy in identifying those attempting to purposefully sandbag and are comparable to other computerized neurocognitive tests.,"['two groups of twenty-five college-aged students (age = 20.8 ± 1.1 years, range 18-25, 48% female) completing CNS Vital Signs instructed to either 1) give their best effort (control) or, 2) give suboptimal performance (sandbag']",[],"['Visual Analog Scale', 'CNS Vital Signs validity indicator accuracy']","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517491', 'cui_str': 'One point one'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0518766'}, {'cui': 'C1947971', 'cui_str': 'Give'}]",[],"[{'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0518766'}, {'cui': 'C0042283', 'cui_str': 'Validity (Epidemiology)'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}]",,0.0639801,Built-in CNS Vital Signs validity indicators have an overall high accuracy in identifying those attempting to purposefully sandbag and are comparable to other computerized neurocognitive tests.,"[{'ForeName': 'M N', 'Initials': 'MN', 'LastName': 'Anderson', 'Affiliation': 'UGA Concussion Research Laboratory, Department of Kinesiology, University of Georgia, Athens, GA, USA.'}, {'ForeName': 'L B', 'Initials': 'LB', 'LastName': 'Lempke', 'Affiliation': 'UGA Concussion Research Laboratory, Department of Kinesiology, University of Georgia, Athens, GA, USA.'}, {'ForeName': 'D H', 'Initials': 'DH', 'LastName': 'Bell', 'Affiliation': 'UGA Concussion Research Laboratory, Department of Kinesiology, University of Georgia, Athens, GA, USA.'}, {'ForeName': 'R C', 'Initials': 'RC', 'LastName': 'Lynall', 'Affiliation': 'UGA Concussion Research Laboratory, Department of Kinesiology, University of Georgia, Athens, GA, USA.'}, {'ForeName': 'J D', 'Initials': 'JD', 'LastName': 'Schmidt', 'Affiliation': 'UGA Concussion Research Laboratory, Department of Kinesiology, University of Georgia, Athens, GA, USA.'}]",Brain injury,['10.1080/02699052.2020.1724332']
572,30687908,Efficacy and safety of non-ablative vaginal erbium:YAG laser treatment as a novel surgical treatment for overactive bladder syndrome: comparison with anticholinergics and β3-adrenoceptor agonists.,"PURPOSE


To examine the efficacy and safety of non-ablative vaginal erbium:YAG laser (VEL) for the treatment of overactive bladder syndrome (OAB) compared with those of two other common pharmacotherapies, namely, anticholinergics and β3-adrenoceptor agonists.
METHODS


Female subjects aged 60-69 years who presented with symptoms of OAB from 2015 to 2017 were assigned to three groups (n = 50) receiving treatment with an anticholinergic agent (4 mg fesoterodine), a β3-adrenoceptor agonist (25 mg mirabegron), or VEL (20 min/session of VEL performed thrice). The OAB symptom score (OABSS), Vaginal Health Index Scale (VHIS), and occurrence of adverse effects were examined prior to and at 1 year following treatment initiation.
RESULTS


The three groups showed significant improvement (p < 0.001) for all items of the OABSS questionnaire. Improved VHIS scores were observed only in the VEL group. Furthermore, after VEL treatment, a negative correlation was observed between questions 3 (urinary urgency) and 4 (urgency urinary incontinence) of the OABSS and VHIS. Regarding safety, no adverse events were observed in the VEL group. However, subjects in the other two groups complained of constipation, as indicated by the Constipation Assessment Scale scores, and mouth dryness. The therapeutic effects were inadequate for one and two subjects in the VEL and β3-adrenoceptor agonist groups, respectively.
CONCLUSIONS


VEL safely and effectively improved OABSS through a different mechanism than that involved in pharmacotherapy. We propose the use of VEL as a novel surgical treatment option in the field of urology.",2019,The three groups showed significant improvement (p < 0.001) for all items of the OABSS questionnaire.,"['overactive bladder syndrome (OAB', 'overactive bladder syndrome', 'Female subjects aged 60-69\xa0years who presented with symptoms of OAB from 2015 to 2017 were assigned to three groups (n\u2009=\u200950) receiving treatment with an']","['VEL', 'non-ablative vaginal erbium:YAG laser treatment', 'anticholinergic agent (4\xa0mg fesoterodine', 'non-ablative vaginal erbium:YAG laser (VEL', 'β3-adrenoceptor agonist (25\xa0mg mirabegron), or VEL', 'anticholinergics and β3-adrenoceptor agonists']","['Improved VHIS scores', 'Constipation Assessment Scale scores, and mouth dryness', 'OABSS', 'adverse events', 'questions 3 (urinary urgency) and 4 (urgency urinary incontinence) of the OABSS and VHIS', 'Efficacy and safety', 'complained of constipation', 'OAB symptom score (OABSS), Vaginal Health Index Scale (VHIS), and occurrence of adverse effects', 'efficacy and safety']","[{'cui': 'C0878773', 'cui_str': 'Overactive Bladder'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0014688', 'cui_str': 'Erbium'}, {'cui': 'C0587723', 'cui_str': 'Lasers, Yttrium Aluminum Garnet'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0242896', 'cui_str': 'Anticholinergic Agents'}, {'cui': 'C2343853', 'cui_str': 'fesoterodine'}, {'cui': 'C0034783', 'cui_str': 'Adrenoceptors'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C2983812', 'cui_str': 'mirabegron'}]","[{'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales (assessment scale)'}, {'cui': 'C0043352', 'cui_str': 'Mouth Dryness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0085606', 'cui_str': 'Urgent desire to urinate (finding)'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0042024', 'cui_str': 'Urinary Incontinence'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0222045'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",,0.0172745,The three groups showed significant improvement (p < 0.001) for all items of the OABSS questionnaire.,"[{'ForeName': 'Nobuo', 'Initials': 'N', 'LastName': 'Okui', 'Affiliation': ""Uro-Gyn.Net Health Care Cooperation, Dr. Okuis' Urogynecology and Urology Clinic, Ootaki 2-6, Yokosuka, Kanagawa, 238-0008, Japan. okuinobuo@gmail.com.""}]",World journal of urology,['10.1007/s00345-019-02644-7']
573,32027547,Physiological response to fluid resuscitation with Ringer lactate versus Plasmalyte in critically ill burn patients.,"The metabolic consequences in vivo of various balanced solutions are poorly known in critically ill patients. The main objective of this study was to describe the metabolic consequences of Plasmalyte versus Ringer lactate (RL) in critically ill burn patients, with a special focus on the plasma clearance of buffer anions (i.e., gluconate, acetate, and lactate). We conducted a randomized trial between August 2017 and October 2018 in a tertiary teaching hospital in Paris, France. Patients with burn total body surface area >30% were randomized to receive Plasmalyte or RL. The primary end point was the base excess 24 h after inclusion. The secondary end points were acetate, gluconate, and lactate plasma concentration, the strong ion difference (SID). Twenty-eight patients were randomized. Twenty-four hours after inclusion, plasma BE was not significantly different in the Plasmalyte and RL groups {-0.9 [95% confidence interval (95% CI): -1.8-0.9] vs. -2.1 [95% CI: -4.6-0.6] mmol/L, respectively,  P  = 0.26}. Plasma gluconate concentration was higher in the Plasmalyte group ( P  < 0.001), with a maximum level of 1.86 (95% CI: 0.98-4.0) mmol/L versus 0 (95% CI: 0-0.15) mmol/L. Plasma acetate and lactate were not significantly different. Ionized calcium level was lower in the Plasmalyte group ( P  = 0.002). Hemodynamics did not differ between groups. To conclude, the alkalinizing effect of Plasmalyte was less important than expected with no difference in base excess compared with RL, in part due to gluconate accumulation. Acetate and lactate did not significantly accumulate. Plasmalyte led to significantly lower ionized calcium levels. NEW & NOTEWORTHY  During fluid resuscitation in burns the alkalinizing effect of Plasmalyte was less important than expected, with no difference in base excess compared with Ringer lactate (RL), in part due to gluconate accumulation. Acetate and lactate did not significantly accumulate. Plasmalyte led to significantly lower ionized calcium levels.",2020,Ionized calcium level was lower in the Plasmalyte® group (p=0.002).,"['August 2017 and October 2018 in a tertiary teaching hospital in Paris, France', 'Twenty-eight patients were randomized', 'critically ill burn patients, with a special focus on the plasma clearance of buffer anions (i.e. gluconate, acetate and lactate', 'Patients with burn total body surface area >30', 'critically ill burn patients', 'critically ill patients']","['Ringer Lactate versus Plasmalyte', 'Plasmalyte® or RL', 'Plasmalyte® versus Ringer lactate (RL']","['Hemodynamics', 'L. Plasma acetate and lactate', 'ionized calcium levels', 'acetate, gluconate and lactate plasma concentration, the strong ion difference (SID', 'plasma BE', 'Plasma gluconate concentration', 'Ionized calcium level', 'Acetate and lactate']","[{'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0020027', 'cui_str': 'Teaching Hospitals'}, {'cui': 'C0331677', 'cui_str': 'Paris (organism)'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0006434', 'cui_str': 'Burns'}, {'cui': 'C0205555', 'cui_str': 'Special (qualifier value)'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0006353', 'cui_str': 'Buffers'}, {'cui': 'C0003075', 'cui_str': 'Anions'}, {'cui': 'C0220836', 'cui_str': 'gluconate'}, {'cui': 'C0000975', 'cui_str': 'Acetate'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0229978', 'cui_str': '90 percent of body surface or more (body structure)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}]","[{'cui': 'C0073385', 'cui_str': ""Hartmann's Solution""}]","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0000975', 'cui_str': 'Acetate'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0201925', 'cui_str': 'Calcium measurement (procedure)'}, {'cui': 'C0220836', 'cui_str': 'gluconate'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0442821', 'cui_str': 'Strong (qualifier value)'}, {'cui': 'C0022023', 'cui_str': 'Ions'}, {'cui': 'C0038644', 'cui_str': 'SIDS'}]",28.0,0.158849,Ionized calcium level was lower in the Plasmalyte® group (p=0.002).,"[{'ForeName': 'Maïté', 'Initials': 'M', 'LastName': 'Chaussard', 'Affiliation': 'Assistance Publique-Hôpitaux de Paris (AP-HP), Groupe Hôpital (GH) Saint Louis-Lariboisière, Department of Anesthesiology and Critical Care and Burn Unit, Paris, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Dépret', 'Affiliation': 'Assistance Publique-Hôpitaux de Paris (AP-HP), Groupe Hôpital (GH) Saint Louis-Lariboisière, Department of Anesthesiology and Critical Care and Burn Unit, Paris, France.'}, {'ForeName': 'Oriane', 'Initials': 'O', 'LastName': 'Saint-Aubin', 'Affiliation': 'Assistance Publique-Hôpitaux de Paris (AP-HP), Groupe Hôpital (GH) Saint Louis-Lariboisière, Department of Anesthesiology and Critical Care and Burn Unit, Paris, France.'}, {'ForeName': 'Mourad', 'Initials': 'M', 'LastName': 'Benyamina', 'Affiliation': 'Assistance Publique-Hôpitaux de Paris (AP-HP), Groupe Hôpital (GH) Saint Louis-Lariboisière, Department of Anesthesiology and Critical Care and Burn Unit, Paris, France.'}, {'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Coutrot', 'Affiliation': 'Assistance Publique-Hôpitaux de Paris (AP-HP), Groupe Hôpital (GH) Saint Louis-Lariboisière, Department of Anesthesiology and Critical Care and Burn Unit, Paris, France.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Jully', 'Affiliation': 'Assistance Publique-Hôpitaux de Paris (AP-HP), Groupe Hôpital (GH) Saint Louis-Lariboisière, Department of Anesthesiology and Critical Care and Burn Unit, Paris, France.'}, {'ForeName': 'Haikel', 'Initials': 'H', 'LastName': 'Oueslati', 'Affiliation': 'Assistance Publique-Hôpitaux de Paris (AP-HP), Groupe Hôpital (GH) Saint Louis-Lariboisière, Department of Anesthesiology and Critical Care and Burn Unit, Paris, France.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Fratani', 'Affiliation': 'Assistance Publique-Hôpitaux de Paris (AP-HP), Groupe Hôpital (GH) Saint Louis-Lariboisière, Department of Anesthesiology and Critical Care and Burn Unit, Paris, France.'}, {'ForeName': 'Alexandru', 'Initials': 'A', 'LastName': 'Cupaciu', 'Affiliation': 'Assistance Publique-Hôpitaux de Paris (AP-HP), Groupe Hôpital (GH) Saint Louis-Lariboisière, Department of Anesthesiology and Critical Care and Burn Unit, Paris, France.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Poniard', 'Affiliation': 'Laboratoire de Biochimie, Hôpital Universitaire Necker-Enfants Malades, AP-HP, Paris, France.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Asehnoune', 'Affiliation': ""Service d'Anesthésie-Réanimation, Centre Hospitalier Universitaire de Nantes, Nantes, Pays De La Loire, France.""}, {'ForeName': 'Solohaja-Faniaha', 'Initials': 'SF', 'LastName': 'Dimby', 'Affiliation': 'Unité de Recherche Clinique, AP-HP, Hôpital Fernand Widal, Statistique, Analyse et Modélisation Multidisciplinaire (SAMM) EA 4543, Université Paris 1 Panthéon Sorbonne, Paris, France.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Mebazaa', 'Affiliation': 'Assistance Publique-Hôpitaux de Paris (AP-HP), Groupe Hôpital (GH) Saint Louis-Lariboisière, Department of Anesthesiology and Critical Care and Burn Unit, Paris, France.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Houze', 'Affiliation': 'Laboratoire de Biochimie, Hôpital Universitaire Necker-Enfants Malades, AP-HP, Paris, France.'}, {'ForeName': 'Matthieu', 'Initials': 'M', 'LastName': 'Legrand', 'Affiliation': 'Assistance Publique-Hôpitaux de Paris (AP-HP), Groupe Hôpital (GH) Saint Louis-Lariboisière, Department of Anesthesiology and Critical Care and Burn Unit, Paris, France.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00859.2019']
574,31826936,Sex differences in implantable cardiac defibrillator therapy according to arrhythmia detection times.,"OBJECTIVE


In implantable cardiac defibrillators (ICDs), long-detection times safely reduce unnecessary and inappropriate therapies. We aimed to evaluate ICD treatment of ventricular arrhythmias in women, compared with men, also taking into account ICD detection.
METHODS


The Advance III trial randomised patients implanted with an ICD for primary or secondary prevention in two arms-long and nominal ventricular arrhythmias detection times before therapy delivering (number of intervals needed to detect (NID) 30/40 and 18/24, respectively). The main endpoint of this post hoc analysis was the incidence of ICD therapies evaluated through Kaplan-Meier method and univariate Cox regression models.
RESULTS


Overall, 1902 patients (304 women, 65±11 years) were randomised. Women showed a lower risk of ICD therapy (HR 0.63, 95% CI 0.43 to 0.93, p=0.022); this difference was observed only in the long-detection arm (HR 0.37, p=0.013) and not in the short detection arm (HR 0.82, p=0.414). No significant sex differences were observed concerning inappropriate therapies and mortality rate. Long-detection settings significantly reduced overall ICD therapies and appropriate ICD therapies, both in women (overall HR 0.31, p=0.007; appropriate HR 0.33, p=0.033) and in men (overall HR 0.69, p=0.006; appropriate HR 0.73, p=0.048).
CONCLUSIONS


In patients with ICDs, the strategy of setting a long-detection time to treat ventricular arrhythmias (NID 30/40) reduces overall delivered therapies, both in women and men, when compared with nominal setting (NID 18/24). The reduction was significantly higher in women. Overall, women were less likely to experience ICD therapies than men; this result was only observed in the long-detection arm.
CLINICAL TRIAL REGISTRATION


NCT00617175.",2020,"Long-detection settings significantly reduced overall ICD therapies and appropriate ICD therapies, both in women (overall HR 0.31, p=0.007; appropriate HR 0.33, p=0.033) and in men (overall HR 0.69, p=0.006; appropriate HR 0.73, p=0.048).
","['1902 patients (304 women, 65±11 years']","['implantable cardiac defibrillator therapy', 'implantable cardiac defibrillators (ICDs']","['lower risk of ICD therapy', 'inappropriate therapies and mortality rate', 'overall ICD therapies and appropriate ICD therapies', 'incidence of ICD therapies evaluated through Kaplan-Meier method and univariate Cox regression models']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0180307', 'cui_str': 'Defibrillators'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3542467', 'cui_str': 'Inappropriate component (foundation metadata concept)'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0442996', 'cui_str': 'Cox (qualifier value)'}, {'cui': 'C0684321', 'cui_str': 'Regression'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}]",1902.0,0.219931,"Long-detection settings significantly reduced overall ICD therapies and appropriate ICD therapies, both in women (overall HR 0.31, p=0.007; appropriate HR 0.33, p=0.033) and in men (overall HR 0.69, p=0.006; appropriate HR 0.73, p=0.048).
","[{'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Gasparini', 'Affiliation': 'Electrophysiology and Pacing Unit, Humanitas Clinical and Research Hospital, IRCCS, Rozzano, Italy maurizio.gasparini@humanitas.it.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Kloppe', 'Affiliation': 'Cardiology and Angiology, Bergmannsheil, Ruhr University, Bochum, Germany.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Lunati', 'Affiliation': ""Cardiology Department, Niguarda Ca' Granda Hospital, Milano, Italy.""}, {'ForeName': 'Niraj', 'Initials': 'N', 'LastName': 'Varma', 'Affiliation': 'Cardiology Department, University of Pennsylvania, Cleveland, Ohio, USA.'}, {'ForeName': 'Jose B', 'Initials': 'JB', 'LastName': 'Martinez-Ferrer', 'Affiliation': 'Department of Cardiology, Hospital Universitario de Araba, Vitoria, Alava, Spain.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Hersi', 'Affiliation': 'College of Medicine, King Saud University, Riyadh, Riyadh Province, Saudi Arabia.'}, {'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Gulaj', 'Affiliation': 'Department of Cardiology, MSWiA Hospital, Bialystok, Poland.'}, {'ForeName': 'Maurits C E F', 'Initials': 'MCEF', 'LastName': 'Wijffels', 'Affiliation': 'Cardiology, St Antonius Hospital, Nieuwegein, Netherlands.'}, {'ForeName': 'Angel', 'Initials': 'A', 'LastName': 'Arenal', 'Affiliation': 'Cardiology Department, Hospital General Universitario Gregorio Marañón, Madrid, Spain.'}, {'ForeName': 'Lorenza', 'Initials': 'L', 'LastName': 'Mangoni di Santo Stefano', 'Affiliation': 'Study and Scientific Solutions, Medtronic Core Clinical Solutions, Rome, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Proclemer', 'Affiliation': 'Department of Cardiology, Azienda Ospedaliera Universitaria S Maria della Misericordia, Udine, Friuli-Venezia Giulia, Italy.'}]",Heart (British Cardiac Society),['10.1136/heartjnl-2019-315650']
575,32074268,Quality of Life and Patient Satisfaction at 7-Year Follow-up of Antibiotic Therapy vs Appendectomy for Uncomplicated Acute Appendicitis: A Secondary Analysis of a Randomized Clinical Trial.,"Importance


Long-term results support antibiotics for uncomplicated acute appendicitis as an alternative to appendectomy. To our knowledge, treatment-related long-term patient satisfaction and quality of life (QOL) are not known.
Objective


To determine patient satisfaction and QOL after antibiotic therapy and appendectomy for treating uncomplicated acute appendicitis.
Interventions


Open appendectomy vs antibiotics with intravenous ertapenem, 1 g once daily, for 3 days followed by 7 days of oral levofloxacin, 500 mg once daily, and metronidazole, 500 mg 3 times per day.
Design, Setting, and Participants


This observational follow-up of the Appendicitis Acuta (APPAC) multicenter randomized clinical trial comparing appendectomy with antibiotics included 530 patients age 18 to 60 years with computed tomography-confirmed uncomplicated acute appendicitis who were randomized to undergo appendectomy (273 [52%]) or receive antibiotics (257 [49%]). The trial was conducted from November 2009 to June 2012; the last follow-up was May 9, 2018. The data were analyzed in February 2019.
Main Outcomes and Measures


In this analysis, post hoc secondary end points of postintervention QOL (EQ-5D-5L) and patient satisfaction and treatment preference were evaluated.
Results


Of the 530 patients enrolled in the trial (appendectomy group: 273 [174 men (64%)] with a median age of 35 years; (antibiotic group: 257 [155 men (60%)] with a median age of 33 years), 423 patients (80%) were available for phone interview at a median follow-up of 7 years; 206 patients (80%) took antibiotics and 217 (79%) underwent appendectomy. Of the 206 patients taking antibiotics, 81 (39%) had undergone appendectomy. The QOL between appendectomy and antibiotic group patients was similar (median health index value, 1.0 in both groups; 95% CI, 0.86-1.0; P = .96). Patients who underwent appendectomy were more satisfied in the treatment than patients taking antibiotics (68% very satisfied, 21% satisfied, 6% indifferent, 4% unsatisfied, and 1% very unsatisfied in the appendectomy group and 53% very satisfied, 21% satisfied, 13% indifferent, 7% unsatisfied, and 6% very unsatisfied in the antibiotic group; P < .001) and in a subgroup analysis this difference was based on the antibiotic group patients undergoing appendectomy. There was no difference in patient satisfaction after successful antibiotic treatment compared with appendectomy (cumulative odds ratio [COR], 7.8; 95% CI, 0.5-1.3; P < .36). Patients with appendectomy or with successful antibiotic therapy were more satisfied than antibiotic group patients who later underwent appendectomy (COR, 7.7; 95% CI, 4.6-12.9; P < .001; COR, 9.7; 95% CI, 5.4-15.3; P < .001, respectively). Of the 81 patients taking antibiotics who underwent appendectomy, 27 (33%) would again choose antibiotics as their primary treatment.
Conclusions and Relevance


In this analysis, long-term QOL was similar after appendectomy and antibiotic therapy for the treatment of uncomplicated acute appendicitis. Patients taking antibiotics who later underwent appendectomy were less satisfied than patients with successful antibiotics or appendectomy.
Trial Registration


Clinicaltrials.gov Identifier: NCT01022567.",2020,"The QOL between appendectomy and antibiotic group patients was similar (median health index value, 1.0 in both groups; 95% CI, 0.86-1.0; P = .96).","['530 patients age 18 to 60 years with computed tomography-confirmed uncomplicated acute appendicitis who were randomized to undergo appendectomy (273 [52%]) or', '530 patients enrolled in the trial (appendectomy group: 273 [174 men (64%)] with a median age of 35 years; (antibiotic group: 257 [155 men (60%)] with a median age of 33 years), 423 patients (80%) were available for phone interview at a median follow-up of 7 years; 206 patients (80%) took antibiotics and 217 (79%) underwent', '81 patients taking antibiotics who underwent appendectomy, 27 (33%) would again choose antibiotics as their primary treatment', 'uncomplicated acute appendicitis', 'Patients with appendectomy or with', 'Uncomplicated Acute Appendicitis', '206 patients taking antibiotics, 81 (39%) had undergone appendectomy']","['appendectomy and antibiotic therapy', 'successful antibiotic therapy', 'Interventions\n\n\nOpen appendectomy vs antibiotics with intravenous ertapenem', 'appendectomy with antibiotics', 'receive antibiotics', 'levofloxacin', 'metronidazole', 'appendectomy', 'Antibiotic Therapy vs Appendectomy', 'antibiotic therapy and appendectomy']","['quality of life (QOL', 'patient satisfaction', 'QOL', 'Quality of Life and Patient Satisfaction', 'postintervention QOL (EQ-5D-5L) and patient satisfaction and treatment preference']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0085693', 'cui_str': 'Acute appendicitis'}, {'cui': 'C0003611', 'cui_str': 'Appendectomy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517604', 'cui_str': 'One hundred and seventy-four'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C4517646', 'cui_str': '217'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0003611', 'cui_str': 'Appendectomy'}, {'cui': 'C0338237', 'cui_str': 'Antibiotic therapy (procedure)'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C1120106', 'cui_str': 'ertapenem'}, {'cui': 'C0282386', 'cui_str': 'Levofloxacin'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}]","[{'cui': 'C0034380'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}]",530.0,0.154225,"The QOL between appendectomy and antibiotic group patients was similar (median health index value, 1.0 in both groups; 95% CI, 0.86-1.0; P = .96).","[{'ForeName': 'Suvi', 'Initials': 'S', 'LastName': 'Sippola', 'Affiliation': 'Turku University Hospital, Division of Digestive Surgery and Urology, University of Turku, Turku, Finland.'}, {'ForeName': 'Jussi', 'Initials': 'J', 'LastName': 'Haijanen', 'Affiliation': 'Turku University Hospital, Division of Digestive Surgery and Urology, University of Turku, Turku, Finland.'}, {'ForeName': 'Lauri', 'Initials': 'L', 'LastName': 'Viinikainen', 'Affiliation': 'Department of Surgery, University of Turku, Turku, Finland.'}, {'ForeName': 'Juha', 'Initials': 'J', 'LastName': 'Grönroos', 'Affiliation': 'Turku University Hospital, Division of Digestive Surgery and Urology, University of Turku, Turku, Finland.'}, {'ForeName': 'Hannu', 'Initials': 'H', 'LastName': 'Paajanen', 'Affiliation': 'Department of Surgery, Mikkeli Central Hospital, Mikkeli, Finland.'}, {'ForeName': 'Tero', 'Initials': 'T', 'LastName': 'Rautio', 'Affiliation': 'Department of Surgery, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Pia', 'Initials': 'P', 'LastName': 'Nordström', 'Affiliation': 'Division of Surgery, Gastroenterology and Oncology, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Markku', 'Initials': 'M', 'LastName': 'Aarnio', 'Affiliation': 'Department of Surgery, Jyväskylä Central Hospital, Jyväskylä, Finland.'}, {'ForeName': 'Tuomo', 'Initials': 'T', 'LastName': 'Rantanen', 'Affiliation': 'Department of Surgery, Kuopio University Hospital, Kuopio, Finland.'}, {'ForeName': 'Saija', 'Initials': 'S', 'LastName': 'Hurme', 'Affiliation': 'Department of Biostatistics, University of Turku, Turku, Finland.'}, {'ForeName': 'Jukka-Pekka', 'Initials': 'JP', 'LastName': 'Mecklin', 'Affiliation': 'Department of Surgery, Jyväskylä Central Hospital, Jyväskylä, Finland.'}, {'ForeName': 'Juhani', 'Initials': 'J', 'LastName': 'Sand', 'Affiliation': 'Department of Health and Medical Services, Päijät-Häme Joint Authority for Health and Wellbeing, Lahti, Finland.'}, {'ForeName': 'Airi', 'Initials': 'A', 'LastName': 'Jartti', 'Affiliation': 'Department of Radiology, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Paulina', 'Initials': 'P', 'LastName': 'Salminen', 'Affiliation': 'Turku University Hospital, Division of Digestive Surgery and Urology, University of Turku, Turku, Finland.'}]",JAMA surgery,['10.1001/jamasurg.2019.6028']
576,32057841,"The role of memory ability, depth and mode of recall in the impact of memory on later consumption.","It has been shown that recalling a meal eaten a few hours earlier (vs. the previous day) leads to reduced snacking ('meal-recall' effect). This study attempted to replicate this effect, by assessing participants' (N = 77, mean age = 33.30 [SD = 14.98], mean BMI = 23.77 [SD = 3.72], 74% female) biscuit consumption during a bogus taste test in two separate sessions, before which participants recalled a recent or a distant meal. It was explored whether factors that might affect the quality of a meal-memory, particularly individual differences in memory ability and depth of recall, would influence the meal-recall effect. To this end, only participants with a low or high memory ability were recruited for the study and were allocated to either an unguided-recall or guided-recall condition. In the unguided condition, participants were asked to recall what they ate, and in the guided condition they were prompted for further details regarding their meal. Participants were asked to either recall their meal out loud through an interview with the experimenter or by writing their recollection down on the computer. Contrary to the initial hypotheses, it was found that only the written group demonstrated the meal-recall effect, whereas the verbal group did not. Moreover, this was specific to the written, unguided group, in which participants ate about 9 g fewer biscuits after recalling a recent (vs. a distant) meal, F (1,15) = 6.07, p = .026, η p 2  = 0.288. The written, guided group's snacking seemed to increase by about 8 g after recalling a recent (vs. a distant) meal, F (1,20) = 7.31, p = .014, η p 2  = 0.268. The meal-recall effect was not evident in the verbal group. Memory ability did not influence the magnitude of the meal-recall effect. The results highlight the importance of contextual factors in modulating the meal-recall effect.",2020,Memory ability did not influence the magnitude of the meal-recall effect.,"[""participants' (N\xa0=\xa077, mean age\xa0"", 'participants with a low or high memory ability', '33.30']","['unguided-recall or guided-recall condition', 'recall their meal out loud through an interview with the experimenter or by writing their recollection down on the computer']",['meal-recall effect'],"[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]","[{'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0439787', 'cui_str': 'Out (qualifier value)'}, {'cui': 'C0332273', 'cui_str': 'Through (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0009622', 'cui_str': 'Computers'}]","[{'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",,0.0214141,Memory ability did not influence the magnitude of the meal-recall effect.,"[{'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Szypula', 'Affiliation': 'Department of Psychology, University of Cambridge, UK.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Ahern', 'Affiliation': 'MRC Epidemiology Unit, University of Cambridge, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Cheke', 'Affiliation': 'Department of Psychology, University of Cambridge, UK. Electronic address: lgc23@cam.ac.uk.'}]",Appetite,['10.1016/j.appet.2020.104628']
577,32027542,Effects of heated water-based versus land-based exercise training on vascular function in individuals with peripheral artery disease.,"Peripheral artery disease (PAD) is an atherosclerotic disease that is associated with poor vascular function, walking impairment, and reduced quality of life. Land-based exercise therapy (LBET) is frequently recommended to improve walking and reduce symptoms. Recently, evidence has suggested that heated-water exercise therapy (HWET) is an effective intervention for PAD. However, the efficacy of LBET versus HWET in PAD patients had not been elucidated. Therefore, we sought to compare effects of LBET with HWET on cardiovascular function, exercise tolerance, physical function, and body composition in PAD patients. PAD patients ( n  = 53) were recruited and randomly assigned to a LBET group ( n  = 25) or HWET group ( n  = 28). The LBET group performed treadmill walking, whereas the HWET group performed walking in heated water for 12 wk. Leg (legPWV) and brachial-to-ankle arterial stiffness (baPWV), blood pressure (BP), ankle-brachial index (ABI), 6-min walking distance (6MWD), claudication onset time (COT), physical function, and body composition were assessed before and after 12 wk. There were significant group-by-time interactions ( P  < 0.05) for legPWV, BP, 6MWD, COT, body composition, and resting metabolic rate (RMR). Both groups significantly reduced ( P  < 0.05) legPWV, BP, and body fat percentage, and HWET measures were significantly lower than LBET measures. Both groups significantly increased 6MWD, COT, and RMR, and HWET group measures were significantly greater than LBET measures. A time effect was noted for baPWV reduction in both groups ( P  < 0.05). These results suggest that both LBET and HWET improve cardiovascular function, exercise tolerance, and body composition, and HWET showed considerably greater improvements compared with LBET in patients with PAD. NEW & NOTEWORTHY  The results of this study reveal for the first time that although land-based exercise therapy is effective for reducing arterial stiffness and blood pressure in patients with peripheral artery disease (PAD), heated-water exercise therapy demonstrates greater benefits on vascular function. The greater improvements in muscular strength, time to onset of claudication, and exercise tolerance after heated-water exercise therapy may have clinical implications for improving quality of life in patients with PAD. The heated-water exercise therapy intervention demonstrated relatively higher exercise training adherence (∼88%) compared with the land-based exercise intervention (∼81%).",2020,"Both groups significantly reduced ( p <0.05) legPWV, BP, body fat percentage, and HWET measures were significantly lower than LBET measures.","['patients with PAD', 'PAD patients ( n =53', 'PAD patients', 'individuals with peripheral artery disease']","['heated water-based versus land-based exercise training', 'HWET', 'LBET and HWET', 'LBET to HWET', 'LBET', 'Land-based exercise therapy (LBET', 'treadmill walking while the HWET group performed walking in heated water for 12-weeks', 'heated-water exercise therapy (HWET']","['baPWV reduction', 'cardiovascular function, exercise tolerance, physical function, and body composition', 'Leg and brachial-to-ankle arterial stiffness (legPWV, baPWV), blood pressure (BP), ankle-brachial index (ABI), 6-min walking distance (6MWD), claudication onset time (COT), physical function, and body composition', '6MWD, COT, and RMR', 'vascular function', 'legPWV, BP, 6MWD, COT, body composition, and resting metabolic rate (RMR', 'cardiovascular function, exercise tolerance, and body composition, and HWET', 'legPWV, BP, body fat percentage, and HWET measures', 'time interactions']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441601', 'cui_str': 'Padding (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Artery Disease'}]","[{'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0452240', 'cui_str': 'Rehabilitation Exercise'}, {'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0007227', 'cui_str': 'Cardiovascular Physiology'}, {'cui': 'C0162521', 'cui_str': 'Exercise Tolerance'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0445456', 'cui_str': 'Brachial (qualifier value)'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0599949', 'cui_str': 'Arterial Stiffness'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C1328319', 'cui_str': 'Ankle Brachial Index'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C1456822', 'cui_str': 'Claudication'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C4082350', 'cui_str': 'Resting Metabolic Rate'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}]",53.0,0.0438435,"Both groups significantly reduced ( p <0.05) legPWV, BP, body fat percentage, and HWET measures were significantly lower than LBET measures.","[{'ForeName': 'Song-Young', 'Initials': 'SY', 'LastName': 'Park', 'Affiliation': 'School of Health and Kinesiology, University of Nebraska-Omaha, Omaha, Nebraska.'}, {'ForeName': 'Alexei', 'Initials': 'A', 'LastName': 'Wong', 'Affiliation': 'Department of Health and Human Performance, Marymount University, Arlington, Virginia.'}, {'ForeName': 'Won-Mok', 'Initials': 'WM', 'LastName': 'Son', 'Affiliation': 'School of Health and Kinesiology, University of Nebraska-Omaha, Omaha, Nebraska.'}, {'ForeName': 'Elizabeth J', 'Initials': 'EJ', 'LastName': 'Pekas', 'Affiliation': 'School of Health and Kinesiology, University of Nebraska-Omaha, Omaha, Nebraska.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00744.2019']
578,32163578,Serum bicarbonate and cardiovascular events in hypertensive adults: results from the Systolic Blood Pressure Intervention Trial.,"BACKGROUND


Low serum bicarbonate level is associated with increased mortality, but its role as a predictor of cardiovascular disease (CVD) is unclear. This study evaluates the association between serum bicarbonate concentration and CVD and whether the effect of intensive blood pressure (BP) lowering on CVD outcomes is modified by serum bicarbonate level.
METHODS


The Systolic Blood Pressure Intervention Trial (SPRINT) randomized participants to a systolic BP target <120 mmHg (intensive treatment) or <140 mmHg (standard treatment). The primary CVD outcome was a composite of nonfatal myocardial infarction (MI), acute coronary syndrome not resulting in MI, stroke, acute decompensated heart failure and CVD death. Cox proportional hazards models adjusted for demographic, clinical and laboratory characteristics were used to evaluate the association of interest in 9334 SPRINT participants (ClinicalTrials.gov: NCT01206062).
RESULTS


Over a median follow-up of 3.33 years (interquartile range 2.87-3.87 years), 618 (6.6%) participants experienced a primary CVD outcome. Participants with serum bicarbonate <22 mEq/L had a significantly higher risk of the primary CVD outcome (hazard ratio 1.54; 95% confidence interval 1.11-2.14, P = 0.01), compared with participants with bicarbonate 22-26 mEq/L. The magnitude of the CVD risk reduction with intensive BP lowering was similar across bicarbonate strata (P-value for interaction = 0.97).
CONCLUSIONS


In hypertensive individuals, serum bicarbonate level <22 mEq/L was associated with an increased CVD risk. The effect of intensive BP lowering on CVD outcomes was not modified by the serum bicarbonate level.",2020,"Participants with serum bicarbonate <22 mEq/L had a significantly higher risk of the primary CVD outcome (hazard ratio 1.54; 95% confidence interval 1.11-2.14, P = 0.01), compared with participants with bicarbonate 22-26 mEq/L.","['participants to a systolic BP target <120\u2009mmHg (intensive treatment) or <140\u2009mmHg (standard treatment', 'hypertensive adults']","['intensive blood pressure (BP', 'intensive BP lowering']","['CVD outcomes', 'Serum bicarbonate and cardiovascular events', 'composite of nonfatal myocardial infarction (MI), acute coronary syndrome not resulting in MI, stroke, acute decompensated heart failure and CVD death', 'CVD risk', 'risk of the primary CVD outcome', 'serum bicarbonate level']","[{'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}]","[{'cui': 'C0428301', 'cui_str': 'Serum bicarbonate measurement'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0332294', 'cui_str': 'Resulting in (attribute)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0581377', 'cui_str': 'Decompensated cardiac failure (disorder)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}]",9334.0,0.215464,"Participants with serum bicarbonate <22 mEq/L had a significantly higher risk of the primary CVD outcome (hazard ratio 1.54; 95% confidence interval 1.11-2.14, P = 0.01), compared with participants with bicarbonate 22-26 mEq/L.","[{'ForeName': 'Mirela', 'Initials': 'M', 'LastName': 'Dobre', 'Affiliation': 'Division of Nephrology and Hypertension, University Hospitals Cleveland Medical Center, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Nicholas M', 'Initials': 'NM', 'LastName': 'Pajewski', 'Affiliation': 'Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Srinivasan', 'Initials': 'S', 'LastName': 'Beddhu', 'Affiliation': 'Veterans Affairs Salt Lake City Healthcare System, University of Utah Health, Salt Lake City, UT, USA.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Chonchol', 'Affiliation': 'Renal Diseases and Hypertension, University of Colorado Denver Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Thomas H', 'Initials': 'TH', 'LastName': 'Hostetter', 'Affiliation': 'Division of Nephrology and Hypertension, University Hospitals Cleveland Medical Center, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': 'VA Medical Center, George Washington University, Washington, DC, USA.'}, {'ForeName': 'Mahboob', 'Initials': 'M', 'LastName': 'Rahman', 'Affiliation': 'Division of Nephrology and Hypertension, University Hospitals Cleveland Medical Center, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Servilla', 'Affiliation': 'Nephrology, New Mexico VA Health Care System, Albuquerque, NM, USA.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Weiner', 'Affiliation': 'Medicine, Nephrology, Tufts Medical Center, Boston, MA, USA.'}, {'ForeName': 'Jackson T', 'Initials': 'JT', 'LastName': 'Wright', 'Affiliation': 'Division of Nephrology and Hypertension, University Hospitals Cleveland Medical Center, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Kalani L', 'Initials': 'KL', 'LastName': 'Raphael', 'Affiliation': 'Veterans Affairs Salt Lake City Healthcare System, University of Utah Health, Salt Lake City, UT, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association",['10.1093/ndt/gfz149']
579,31692373,Safety and Effectiveness of an Investigational Insulin Delivery Device Providing Basal/Bolus Therapy with Rapid-Acting or Regular Human Insulin in Adults with Type 2 Diabetes.,"Background:  This study undertook to assess usability, 24-h glycemic profiles, and safety of an investigational basal/bolus insulin delivery device (IDD) providing rapid-acting or regular human insulin (RHI) for people with type 2 diabetes (T2D) transitioning from multiple daily insulin injections (MDIs).  Methods:  This prospective, single-center, open-label two-period study enrolled adults with T2D and glycated hemoglobin (HbA1c) 7%-11% (53-97 mmol/M). Participants continued the usual MDI therapy during a 2- to 3-day in-clinic MDI period and then within 7 days were switched to the IDD, using current insulin dose, for a 6-day in-clinic IDD period, with blinded continuous glucose monitoring throughout the in-clinic periods.  Results:  We enrolled 21 participants (mean ± standard deviation age 57 ± 8 years; HbA1c 8.2% ± 0.9% [66 ± 9.8 mmol/M]) using U-100 insulin lispro ( n  = 11) or who switched to U-100 RHI ( n  = 10). Glycemic measures improved from the MDI to IDD period, including fasting blood glucose (BG), 141.2 ± 38.3 mg/dL (7.8 ± 2.1 mmol/L) versus 121.2 ± 35.0 mg/dL (6.7 ± 1.9 mmol/L;  P  = 0.002), respectively; 24-h mean BG, 137.0 ± 20.5 mg/dL (7.6 ± 1.1 mmol/L) versus 125.0 ± 16.5 mg/dL (6.9 ± 0.9 mmol/L;  P  = 0.004); and time in range (at 70-180 mg/dL; 3.9-10 mmol/L), 81.0% ± 14.4% versus 87.5% ± 10.6% ( P  = 0.008). No significant differences between MDIs and IDD use were recorded for time <70 mg/dL (1.6% ± 2.7% vs. 3.1% ± 2.7%,  P  = 0.08), CV%, or mean of daily differences. Mean amplitude of glycemic excursions was significantly lower with the IDD ( P  = 0.011). There were no significant differences between insulin lispro and RHI for any glycemic measure. No serious adverse events were recorded.  Conclusions:  In the context of this exploratory study, the IDD was safe and effective to administer insulin lispro and RHI for adults with T2D.",2020,Mean amplitude of glycemic excursions (MAGE) was significantly lower with the IDD (P=0.011).,"['enrolled adults with T2D and HbA1c 7-11% (53-97 mmol/mol', 'adults with T2D', '21 participants (mean±SD age 57±8 years; HbA1c 8.2±0.9% [66±9.8 mmol/mol]) using', 'adults with type 2 diabetes', 'people with type 2 diabetes (T2D) transitioning from multiple daily insulin injections (MDI']","['usual MDI therapy', 'U-100 insulin lispro (n=11) or switched to U-100 RHI', 'investigational basal/bolus insulin delivery device (IDD) providing rapid-acting or regular human insulin (RHI', 'investigational insulin delivery device providing basal/bolus therapy with rapid-acting or regular human insulin']","['fasting blood glucose (BG', 'Glycemic measures', 'Mean amplitude of glycemic excursions (MAGE', 'Safety and effectiveness', 'MDI and IDD', 'insulin lispro and RHI for any glycemic measure', 'serious adverse events']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0586328', 'cui_str': 'Insulin injection'}, {'cui': 'C0993596', 'cui_str': 'Metered Dose Inhaler'}]","[{'cui': 'C0993596', 'cui_str': 'Metered Dose Inhaler'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0293359', 'cui_str': 'Insulin Lispro'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0795635', 'cui_str': 'insulin (human)'}]","[{'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0993596', 'cui_str': 'Metered Dose Inhaler'}, {'cui': 'C0293359', 'cui_str': 'Insulin Lispro'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",21.0,0.0351608,Mean amplitude of glycemic excursions (MAGE) was significantly lower with the IDD (P=0.011).,"[{'ForeName': 'Ronnie', 'Initials': 'R', 'LastName': 'Aronson', 'Affiliation': 'LMC Diabetes and Endocrinology, Toronto, Canada.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Mahoney', 'Affiliation': 'Medical Affairs, Becton, Dickinson and Company, Franklin Lakes, New Jersey.'}, {'ForeName': 'Drilon', 'Initials': 'D', 'LastName': 'Saliu', 'Affiliation': 'Medical Affairs, Becton, Dickinson and Company, Franklin Lakes, New Jersey.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Sze', 'Affiliation': 'Medical Affairs, Becton, Dickinson and Company, Franklin Lakes, New Jersey.'}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Morel', 'Affiliation': 'Global Clinical Development, Becton, Dickinson and Company, Le Pont de Claix, France.'}, {'ForeName': 'Leya', 'Initials': 'L', 'LastName': 'Bergquist', 'Affiliation': 'Human Factors Engineering, R&D, Becton, Dickinson and Company, Franklin Lakes, New Jersey.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Hirsch', 'Affiliation': 'Medical Affairs, Becton, Dickinson and Company, Franklin Lakes, New Jersey.'}]",Diabetes technology & therapeutics,['10.1089/dia.2019.0356']
580,31936727,Effect of Ten Weeks of Creatine Monohydrate Plus HMB Supplementation on Athletic Performance Tests in Elite Male Endurance Athletes.,"Creatine monohydrate (CrM) and β-hydroxy β-methylbutyrate (HMB) are common ergogenic aids in the field of sports and are frequently used in an isolated way. However, there are a few studies that have investigated the effect of combining both supplements on different variables related to performance, with controversial results. Therefore, the main purpose of this study was to determine the efficacy and the degree of potentiation of 10 weeks of CrM plus HMB supplementation on sports performance, which was measured by an incremental test to exhaustion in elite male traditional rowers. In this placebo-controlled, double-blind trial, 10-week study, participants ( n  = 28) were randomized to a placebo group (PLG;  n  = 7), CrM group (0.04 g/kg/day of CrM;  n  = 7), HMB group (3 g/day of HMB;  n  = 7) and CrM-HMB group (0.04 g/kg/day of CrM plus 3 g/day of HMB;  n  = 7). Before and after 10 weeks of different treatments, an incremental test was performed on a rowing ergometer to calculate the power that each rower obtained at the anaerobic threshold (WAT), and at 4 mmol (W4) and 8 mmol (W8) of blood lactate concentration. There were no significant differences in WAT and W4 among groups or in body composition. However, it was observed that the aerobic power achieved at W8 was significantly higher in the CrM-HMB group than in the PLG, CrM and HMB groups ( p  < 0.001; η2 p  = 0.766). Likewise, a synergistic effect of combined supplementation was found for the sum of the two supplements separately at WAT (CrM-HMBG = 403.19% vs. CrMG+HMBG = 337.52%), W4 (CrM-HMBG = 2736.17% vs. CrMG+HMBG = 1705.32%) and W8 (CrM-HMBG = 1293.4% vs. CrMG+HMBG = 877.56%). In summary, CrM plus HMB supplementation over 10 weeks showed a synergistic effect on aerobic power (measured as WAT, W4, and W8) during an incremental test but had no influence muscle mass.",2020,There were no significant differences in WAT and W4 among groups or in body composition.,"['elite male traditional rowers', 'participants ( n  = 28', 'Elite Male Endurance Athletes']","['HMB', 'CrM', 'Creatine Monohydrate Plus HMB Supplementation', 'CrM plus HMB supplementation', 'placebo', 'CrM-HMB', 'Creatine monohydrate (CrM) and β-hydroxy β-methylbutyrate (HMB', 'rowing ergometer to calculate the power that each rower obtained at the anaerobic threshold (WAT']","['aerobic power achieved at W8', 'synergistic effect on aerobic power', 'Athletic Performance Tests']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C0873188', 'cui_str': 'Creatine Monohydrate'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4505111', 'cui_str': 'Rowing'}, {'cui': 'C0444686', 'cui_str': 'Calculated (qualifier value)'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0002749', 'cui_str': 'Anaerobic Threshold'}]","[{'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0871966', 'cui_str': 'Sports Performance'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",,0.173447,There were no significant differences in WAT and W4 among groups or in body composition.,"[{'ForeName': 'Julen', 'Initials': 'J', 'LastName': 'Fernández-Landa', 'Affiliation': 'Laboratory of Human Performance, Department of Physical Education and Sport, Faculty of Education, Sport Section, University of the Basque Country, 01007 Vitoria, Spain.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Fernández-Lázaro', 'Affiliation': 'Department of Cellular Biology, Histology and Pharmacology, Faculty of Health Sciences, University of Valladolid, Campus de Soria, 42003 Soria, Spain.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Calleja-González', 'Affiliation': 'Laboratory of Human Performance, Department of Physical Education and Sport, Faculty of Education, Sport Section, University of the Basque Country, 01007 Vitoria, Spain.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Caballero-García', 'Affiliation': 'Department of Anatomy and Radiology, Faculty of Health Sciences, University of Valladolid, Campus de Soria, 42003 Soria, Spain.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Córdova Martínez', 'Affiliation': 'Department of Biochemistry, Molecular Biology and Physiology, Faculty of Health Sciences, University of Valladolid, Campus de Soria, 42003 Soria, Spain.'}, {'ForeName': 'Patxi', 'Initials': 'P', 'LastName': 'León-Guereño', 'Affiliation': 'Faculty of Psychology and Education, University of Deusto, Campus of Donostia-San Sebastián, 20012 San Sebastián, Guipúzcoa, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Mielgo-Ayuso', 'Affiliation': 'Department of Biochemistry, Molecular Biology and Physiology, Faculty of Health Sciences, University of Valladolid, Campus de Soria, 42003 Soria, Spain.'}]",Nutrients,['10.3390/nu12010193']
581,31936767,"Improving the Metabolic and Mental Health of Children with Obesity: A School-Based Nutrition Education and Physical Activity Intervention in Wuhan, China.","This study aimed to evaluate the effectiveness of a school-based nutrition education and physical activity intervention on cardiovascular risk profile and mental health outcomes among Chinese children with obesity. Two primary schools were randomly allocated to the control group (CG) and the intervention group (IG). We selected children with obesity from 1340 students in the third and fourth grades as participants. The IG received 8 months of nutrition education and physical activity intervention, while the CG was waitlisted. A generalized estimating equation model was applied to assess repeated variables over time. A total of 171 children with obesity (99 IG and 72 CG) aged 9.8 ± 0.7 years completed the post-intervention stage. Compared with baseline, significant reductions were observed within the IG for depression and fasting plasma glucose at post-intervention. After adjusting for confounders, group and time interaction effects showed that the IG achieved improvements in the risk of poor well-being ( p  = 0.051) and social anxiety ( p  = 0.029), had decreased diastolic blood pressure ( p  = 0.020) and fasting plasma glucose ( p  < 0.001), and had significantly increased high-density lipoprotein ( p  < 0.001) from baseline to post-intervention relative to the CG. The effects of school-based nutrition education and physical activity intervention on children with obesity are diverse, including not only the improvement of metabolic health but also mental health promotion.",2020,"Compared with baseline, significant reductions were observed within the IG for depression and fasting plasma glucose at post-intervention.","['Children with Obesity', '171 children with obesity (99 IG and 72 CG) aged 9.8 ± 0.7 years completed the post-intervention stage', 'children with obesity', 'Chinese children with obesity', 'Two primary schools', 'children with obesity from 1340 students in the third and fourth grades as participants']","['nutrition education and physical activity intervention', 'school-based nutrition education and physical activity intervention', 'School-Based Nutrition Education and Physical Activity Intervention', 'control group (CG']","['fasting plasma glucose', 'depression and fasting plasma glucose', 'risk of poor well-being', 'cardiovascular risk profile and mental health outcomes', 'diastolic blood pressure', 'high-density lipoprotein', 'social anxiety']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517474', 'cui_str': '0.7 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0033145', 'cui_str': 'Primary Schools'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0205438', 'cui_str': 'Fourth (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}]","[{'cui': 'C0204934', 'cui_str': 'Nutritional education'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0424166', 'cui_str': 'Social Anxiety'}]",171.0,0.0229521,"Compared with baseline, significant reductions were observed within the IG for depression and fasting plasma glucose at post-intervention.","[{'ForeName': 'Hong-Jie', 'Initials': 'HJ', 'LastName': 'Yu', 'Affiliation': 'School of Health Sciences, Wuhan University, Wuhan 430071, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': 'Wuhan Center for Disease Prevention and Control, Wuhan 430022, China.'}, {'ForeName': 'Yong-Feng', 'Initials': 'YF', 'LastName': 'Hu', 'Affiliation': 'Xinzhou Center for Disease Prevention and Control, Wuhan 431400, China.'}, {'ForeName': 'Chang-Feng', 'Initials': 'CF', 'LastName': 'Li', 'Affiliation': 'Wuhan Center for Disease Prevention and Control, Wuhan 430022, China.'}, {'ForeName': 'Shuai', 'Initials': 'S', 'LastName': 'Yuan', 'Affiliation': 'Unit of Cardiovascular and Nutritional Epidemiology, Institute of Environmental Medicine, Karolinska Institutet, Nobelsväg 13, 17177 Stockholm, Sweden.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'School of Health Sciences, Wuhan University, Wuhan 430071, China.'}, {'ForeName': 'Miaobing', 'Initials': 'M', 'LastName': 'Zheng', 'Affiliation': 'Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Sciences, Deakin University, Geelong, VIC 3125, Australia.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Gong', 'Affiliation': 'Wuhan Center for Disease Prevention and Control, Wuhan 430022, China.'}, {'ForeName': 'Qi-Qiang', 'Initials': 'QQ', 'LastName': 'He', 'Affiliation': 'School of Health Sciences, Wuhan University, Wuhan 430071, China.'}]",Nutrients,['10.3390/nu12010194']
582,31936428,The Effect of a Low GI Diet on Truncal Fat Mass and Glycated Hemoglobin in South Indians with Type 2 Diabetes-A Single Centre Randomized Prospective Study.,"BACKGROUND


There has been no previous study that has investigated the effect of a low glycemic index (LGI) diet with local recipes of South Indian cuisine on the body fat composition using dual-energy X-ray absorptiometry (DXA). Truncal obesity has been associated with the risk of metabolic disorders and cardiovascular diseases.
AIM


The aim of this study was to examine the effect of a low GI diet on glycemic control and body composition in people with type 2 diabetes in South India.
METHOD


This was a prospective and randomized controlled study that was conducted over a period of 24 weeks. A total of 40 participants were recruited from the Department of Endocrinology and Diabetes Outpatient in Kerala, South India. All the patients had type 2 diabetes and were randomly assigned and given advice and instructions to follow either a low GI diet plan ( n  = 18) or their usual diet, which served as control ( n  = 18). The advice was reinforced throughout the study period. Dietary compliance was evaluated based on a 24 h dietary recall at weeks 3, 11, 12, 18, 23, and 24. The age of the subjects ranged from 35 to 65 years. Anthropometric, body composition, and cardio-metabolic parameters were measured according to standard procedures. T-tests were conducted to compare differences between intervention and control groups and the Pearson correlation coefficient was used to evaluate associations between the variables.
RESULTS


There were significant reductions ( p  < 0.05) in the low GI diet compared to the control group with respect to weight, body mass index (BMI), and triceps skinfold thickness. Similarly, significant reductions were observed in the low GI diet group with respect to region, total fat, android, and gynoid fat mass and the differences between the groups were significant at  p  < 0.05. There was also a positive correlation between BMI and android fat mass (r = 0.745), total fat mass (r = 0.661), total truncal mass (r = 0.821), and truncal fat (r = 0.707). There was a significant reduction in glycated hemoglobin in the low GI diet group compared to the control group at  p  < 0.05.
CONCLUSION


This study has demonstrated that there was a significant reduction ( p  < 0.05) of truncal obesity and glycated hemoglobin in patients with type 2 diabetes on a local diet of South Indian cuisine with low GI compared with the control.",2020,"There were significant reductions ( p  < 0.05) in the low GI diet compared to the control group with respect to weight, body mass index (BMI), and triceps skinfold thickness.","['patients with type 2 diabetes', 'South Indians with Type 2 Diabetes', 'A total of 40 participants were recruited from the Department of Endocrinology and Diabetes Outpatient in Kerala, South India', 'people with type 2 diabetes in South India', 'patients had type 2 diabetes']","['Low GI Diet', 'low GI diet plan ( n  = 18) or their usual diet', 'low GI diet']","['truncal obesity and glycated hemoglobin', 'glycemic control and body composition', 'Anthropometric, body composition, and cardio-metabolic parameters', 'Dietary compliance', 'total fat, android, and gynoid fat mass', 'glycated hemoglobin', 'total fat mass', 'truncal fat', 'Truncal Fat Mass and Glycated Hemoglobin', 'total truncal mass', 'BMI and android fat mass', 'weight, body mass index (BMI), and triceps skinfold thickness']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0014137', 'cui_str': 'Endocrinology'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0443018', 'cui_str': 'Kerala (qualifier value)'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C1301732', 'cui_str': 'Planned'}]","[{'cui': 'C4551560', 'cui_str': 'Central obesity (disorder)'}, {'cui': 'C0017853', 'cui_str': 'Hemoglobin, Glycosylated'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0718532', 'cui_str': 'Android'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0037302', 'cui_str': 'Skinfold Thickness'}]",40.0,0.0196334,"There were significant reductions ( p  < 0.05) in the low GI diet compared to the control group with respect to weight, body mass index (BMI), and triceps skinfold thickness.","[{'ForeName': 'Nivedita', 'Initials': 'N', 'LastName': 'Pavithran', 'Affiliation': 'Department of Clinical Nutrition, Amrita Institute of Medical Sciences and Research Centre, Amrita VishwaVidyapeetham, Kochi, Kerala 682041, India.'}, {'ForeName': 'Harish', 'Initials': 'H', 'LastName': 'Kumar', 'Affiliation': 'Department of Endocrinology, Amrita Institute of Medical Sciences and Research Centre, Amrita VishwaVidyapeetham, Kochi, Kerala 682041, India.'}, {'ForeName': 'Arun Somasekharan', 'Initials': 'AS', 'LastName': 'Menon', 'Affiliation': 'Department of Endocrinology, Amrita Institute of Medical Sciences and Research Centre, Amrita VishwaVidyapeetham, Kochi, Kerala 682041, India.'}, {'ForeName': 'Gopala Krishna', 'Initials': 'GK', 'LastName': 'Pillai', 'Affiliation': 'Department of General Medicine, Amrita Institute of Medical Sciences and Research Centre, Amrita VishwaVidyapeetham, Kochi, Kerala 682041, India.'}, {'ForeName': 'Karimassery Ramaiyer', 'Initials': 'KR', 'LastName': 'Sundaram', 'Affiliation': 'Department of Biostatistics, Amrita Institute of Medical Sciences and Research Centre, Amrita VishwaVidyapeetham, Kochi, Kerala 682041, India.'}, {'ForeName': 'Omorogieva', 'Initials': 'O', 'LastName': 'Ojo', 'Affiliation': 'School of Health Sciences, University of Greenwich, London SE9 2UG, UK.'}]",Nutrients,['10.3390/nu12010179']
583,31778446,Ocular surface changes in the treatment of rosacea: comparison between low-dose oral isotretinoin and doxycycline.,"PURPOSE


To compare the impact of ocular changes between systemic treatment with doxycycline and low-dose oral isotretinoin in patients with moderate-to-severe papulopustular rosacea.
METHODS


Patients were randomized to receive either isotretinoin 0.3-0.4 mg/kg (group A) or doxycycline 100 mg/day (group B) for 16 weeks. Ocular symptoms were searched and evaluated, including best-corrected visual acuity (BCVA), Schirmer test, breakup time, rose bengal staining score, and meibomian gland dysfunction grading. The patients were retested at the end of treatment.
RESULTS


The present study included 39 patients (30 females and 9 males). Best-corrected visual acuity was > 20/30 in >90% of patients in both groups and did not change after treatment. After treatment, improvement in ocular symptoms and meibomian gland dysfunction was more pronounced in group B (p<0.05); the other parameters did not reach statistical significance.
CONCLUSION


Doxycycline improved meibomian gland dysfunction, ocular symptoms, and ocular surface in patients with rosacea. Even though some patients experienced worsening meibomian gland dysfunction and symptoms, no subject experienced any serious complications after administration of low-dose isotretinoin.",2020,Best-corrected visual acuity was > 20/30 in >90% of patients in both groups and did not change after treatment.,"['Patients', '39 patients (30 females and 9 males', 'patients with moderate-to-severe papulopustular rosacea', 'patients with rosacea', 'rosacea']","['doxycycline', 'doxycycline and low-dose oral isotretinoin', 'isotretinoin 0.3-0.4 mg/kg (group A) or doxycycline', 'Doxycycline']","['ocular symptoms and meibomian gland dysfunction', 'best-corrected visual acuity (BCVA), Schirmer test, breakup time, rose bengal staining score, and meibomian gland dysfunction grading', 'meibomian gland dysfunction, ocular symptoms, and ocular surface', 'Best-corrected visual acuity', 'Ocular symptoms', 'worsening meibomian gland dysfunction and symptoms', 'serious complications']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C1449853', 'cui_str': 'Papulopustular Rosacea'}, {'cui': 'C0035854', 'cui_str': 'Rosacea'}]","[{'cui': 'C0013090', 'cui_str': 'Doxycycline'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0022265', 'cui_str': 'Isotretinoin'}, {'cui': 'C4068885', 'cui_str': 'Zero point three'}, {'cui': 'C4517457', 'cui_str': 'Zero point four'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}]","[{'cui': 'C4521296', 'cui_str': 'Ocular (intended site)'}, {'cui': 'C1275684', 'cui_str': 'MGD-Meibomian gland dysfunction'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C0200152', 'cui_str': ""Schirmer's test (procedure)""}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0035857', 'cui_str': 'Rose Bengal'}, {'cui': 'C0487602', 'cui_str': 'Staining'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",39.0,0.0566852,Best-corrected visual acuity was > 20/30 in >90% of patients in both groups and did not change after treatment.,"[{'ForeName': 'Fabio Mendonça Xavier', 'Initials': 'FMX', 'LastName': 'Andrade', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, Universidade Federal de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Fabiola Rosa', 'Initials': 'FR', 'LastName': 'Picosse', 'Affiliation': 'Department of Dermatology, Universidade Federal de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Laura Pires da', 'Initials': 'LPD', 'LastName': 'Cunha', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, Universidade Federal de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Camila Maia', 'Initials': 'CM', 'LastName': 'Valente', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, Universidade Federal de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Fernanda Machado', 'Initials': 'FM', 'LastName': 'Bezerra', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, Universidade Federal de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Helio', 'Initials': 'H', 'LastName': 'Miot', 'Affiliation': 'Department of Dermatology, Universidade Estadual Paulista ""Julio de Mesquita Filho"", São Paulo, SP, Brazil.'}, {'ForeName': 'Edileia', 'Initials': 'E', 'LastName': 'Bagatin', 'Affiliation': 'Department of Dermatology, Universidade Federal de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Denise de', 'Initials': 'D', 'LastName': 'Freitas', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, Universidade Federal de São Paulo, São Paulo, SP, Brazil.'}]",Arquivos brasileiros de oftalmologia,['10.5935/0004-2749.20200016']
584,31936720,"The Effect of Walnut Consumption on  n -3 Fatty Acid Profile of Healthy People Living in a Non-Mediterranean West Balkan Country, a Small Scale Randomized Study.","People living in non-Mediterranean West Balkan countries have diets with a low  n -3 polyunsaturated fatty acid (PUFA) content. Walnuts, a traditional Serbian food, could be an excellent source of  n -3 PUFA. The first sub-study evaluated the fatty acid and mineral content of Serbian walnuts, demonstrating that walnuts had the high content of linolenic acid (C18:3,  n -3 ALA). The second sub-study assessed the consumption of walnuts ( Juglans regia  L.) and total  n -3-fatty acid intake in apparently healthy Serbian residents, using 24-h dietary recalls ( n  = 352). An inadequate intake of  n -3 fatty acids and a low consumption of walnuts was seen. Additionally, we evaluated the fatty acid profile of healthy Serbian adults ( n  = 110) and finally, via a randomized intervention 4-weeks study, we assessed the effects of walnut consumption on  n -3 fatty acid profile of participants ( n  = 18). The plasma content of  n -3 PUFA was low and the  n -6/ n -3 ratio was high in our study participants. The  n -3 plasma fatty acid profile was improved after 4 weeks of walnut consumption, meaning that ALA, eicosapentaenoic acid, and total  n -3 were significantly increased. The results of our study pointed out the potential health benefits of walnuts consumption on amelioration of the  n -3 fatty acid profile that should be taken into account in preventive management programs. The higher conversion of ALA to EPA (>10%) in examined study participants, suggests the importance of a moderate walnut consumption.",2020,The plasma content of  n -3 PUFA was low and the  n -6/ n -3 ratio was high in our study participants.,"['People living in non-Mediterranean West Balkan countries', 'apparently healthy Serbian residents, using 24-h dietary recalls ( n  = 352', 'healthy Serbian adults ( n  = 110', 'Healthy People Living in a Non-Mediterranean West Balkan Country']","['Walnut Consumption', 'walnuts consumption']","['fatty acid profile', 'consumption of walnuts ( Juglans regia  L.) and total  n -3-fatty acid intake', 'n -3 plasma fatty acid profile', 'plasma content of  n -3 PUFA']","[{'cui': 'C3494471', 'cui_str': 'Balkans'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}]","[{'cui': 'C0993635', 'cui_str': 'English walnut'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0993635', 'cui_str': 'English walnut'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0556124', 'cui_str': 'N-3 fatty acid intake (observable entity)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}]",352.0,0.0387494,The plasma content of  n -3 PUFA was low and the  n -6/ n -3 ratio was high in our study participants.,"[{'ForeName': 'Gordana', 'Initials': 'G', 'LastName': 'Petrović-Oggiano', 'Affiliation': 'Center of Research Excellence in Nutrition and Metabolism, Institute for Medical Research, University of Belgrade, 11000 Belgrade, Serbia.'}, {'ForeName': 'Jasmina', 'Initials': 'J', 'LastName': 'Debeljak-Martačić', 'Affiliation': 'Center of Research Excellence in Nutrition and Metabolism, Institute for Medical Research, University of Belgrade, 11000 Belgrade, Serbia.'}, {'ForeName': 'Slavica', 'Initials': 'S', 'LastName': 'Ranković', 'Affiliation': 'Center of Research Excellence in Nutrition and Metabolism, Institute for Medical Research, University of Belgrade, 11000 Belgrade, Serbia.'}, {'ForeName': 'Biljana', 'Initials': 'B', 'LastName': 'Pokimica', 'Affiliation': 'Center of Research Excellence in Nutrition and Metabolism, Institute for Medical Research, University of Belgrade, 11000 Belgrade, Serbia.'}, {'ForeName': 'Alma', 'Initials': 'A', 'LastName': 'Mirić', 'Affiliation': 'Center of Research Excellence in Nutrition and Metabolism, Institute for Medical Research, University of Belgrade, 11000 Belgrade, Serbia.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Glibetić', 'Affiliation': 'Center of Research Excellence in Nutrition and Metabolism, Institute for Medical Research, University of Belgrade, 11000 Belgrade, Serbia.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Popović', 'Affiliation': 'Center of Research Excellence in Nutrition and Metabolism, Institute for Medical Research, University of Belgrade, 11000 Belgrade, Serbia.'}]",Nutrients,['10.3390/nu12010192']
585,31958491,"Optimal lighting levels for stair safety: Influence of lightbulb type and brightness on confidence, dynamic balance and stepping characteristics.","INTRODUCTION


Poor lighting has been associated with stair falls in young and older adults. However, current guidelines for illuminating stairs seem arbitrary, differ widely between sources, and are often difficult to interpret.
AIMS


Here we examined the influence of real-world bulb illumination properties on stair descent safety in young and older adults, with a view to generating preliminary evidence for appropriate lightbulb use/stair illumination.
METHODS


Stair tread illumination (lx) was measured in a standard UK home (2.23 m ceiling) from a low (50 W; 630 lm) and a high (103 W, 1450 lm) power compact fluorescent lamp (CFL) bulb from the time they were turned on until they reached full brightness. This enabled modelling of their illumination characteristics during warm up. Illumination was also measured from a low (40 W, 470 lm) and a high (100 W, 1521 lm) power LED bulb at first turn-on. Computer-controlled custom lighting then replicated these profiles, in addition to a Bright control (350 lx), on an instrumented staircase descended (3 × trials per light condition) by 12 young (25.3 ± 4.4 years; 5 males), 12 higher ability older (HAOA: 69.6 ± 4.7 years; 5 males) and 13 lower ability older (LAOA: 72.4 ± 4.2; 3 males) healthy adults. Older adults were allocated to ability groups based on physiological and cognitive function. Stair-specific confidence was assessed prior to the first descent in each new lighting condition, and whole-body 3D kinematics (Vicon) quantified margins of stability and foot clearances with respect to the step edges. Mixed ANOVAs examined these measures for within-subject effects of lighting (×5), between-subject effects of age (×3) and interactions between lighting and age.
RESULTS


Use of CFL bulbs led to lower self-reported confidence in older adults (20.37%, p = .01), and increased margins of stability (12.47%, p = .015) and foot clearances with respect to the step edges (10.36%, p = .003). Importantly, using CFL bulbs increased foot clearance variability with respect to the bottom step (32.74%, p = .046), which is where a high proportion of falls occur.
CONCLUSION


Stair-tread illumination from CFL bulbs at first turn on leads to less safe stair negotiation. We suggest high powered LED bulbs may offer a safer alternative.",2020,"RESULTS


Use of CFL bulbs led to lower self-reported confidence in older adults (20.37%, p = .01), and increased margins of stability (12.47%, p = .015) and foot clearances with respect to the step edges (10.36%, p = .003).","['Older adults', 'young and older adults', '12 young (25.3\u202f±\u202f4.4\u202fyears; 5 males), 12 higher ability older (HAOA: 69.6\u202f±\u202f4.7\u202fyears; 5 males) and 13 lower ability older (LAOA: 72.4\u202f±\u202f4.2; 3 males) healthy adults']",['real-world bulb illumination properties'],"['margins of stability', 'confidence, dynamic balance and stepping characteristics', 'stair descent safety', 'foot clearances', 'safe stair negotiation', 'foot clearance variability', 'Stair specific confidence']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C4517761', 'cui_str': '4.4'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C4517758', 'cui_str': 'Four point two'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C1449865', 'cui_str': 'Bulb (substance)'}, {'cui': 'C1964256', 'cui_str': 'Illumination - action'}, {'cui': 'C0871161', 'cui_str': 'Property (attribute)'}]","[{'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0680727', 'cui_str': 'Negotiation'}, {'cui': 'C0205369', 'cui_str': 'Specified'}]",1521.0,0.0151048,"RESULTS


Use of CFL bulbs led to lower self-reported confidence in older adults (20.37%, p = .01), and increased margins of stability (12.47%, p = .015) and foot clearances with respect to the step edges (10.36%, p = .003).","[{'ForeName': 'Neil M', 'Initials': 'NM', 'LastName': 'Thomas', 'Affiliation': 'Research to Improve Stair Climbing Safety (RISCS), Faculty of Science, School of Sport and Exercise Sciences, Liverpool John Moores University, Byrom Street, Liverpool L3 3AF, United Kingdom. Electronic address: N.M.Thomas@ljmu.ac.uk.'}, {'ForeName': 'Timmion', 'Initials': 'T', 'LastName': 'Skervin', 'Affiliation': 'Research to Improve Stair Climbing Safety (RISCS), Faculty of Science, School of Sport and Exercise Sciences, Liverpool John Moores University, Byrom Street, Liverpool L3 3AF, United Kingdom.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Foster', 'Affiliation': 'Research to Improve Stair Climbing Safety (RISCS), Faculty of Science, School of Sport and Exercise Sciences, Liverpool John Moores University, Byrom Street, Liverpool L3 3AF, United Kingdom.'}, {'ForeName': 'Thomas D', 'Initials': 'TD', 'LastName': ""O'Brien"", 'Affiliation': 'Research to Improve Stair Climbing Safety (RISCS), Faculty of Science, School of Sport and Exercise Sciences, Liverpool John Moores University, Byrom Street, Liverpool L3 3AF, United Kingdom.'}, {'ForeName': 'Mark G', 'Initials': 'MG', 'LastName': 'Carpenter', 'Affiliation': 'School of Kinesiology, The University of British Columbia, University Blvd, V6T 1Z3, Canada.'}, {'ForeName': 'Constantinos N', 'Initials': 'CN', 'LastName': 'Maganaris', 'Affiliation': 'Research to Improve Stair Climbing Safety (RISCS), Faculty of Science, School of Sport and Exercise Sciences, Liverpool John Moores University, Byrom Street, Liverpool L3 3AF, United Kingdom.'}, {'ForeName': 'Vasilios', 'Initials': 'V', 'LastName': 'Baltzopoulos', 'Affiliation': 'Research to Improve Stair Climbing Safety (RISCS), Faculty of Science, School of Sport and Exercise Sciences, Liverpool John Moores University, Byrom Street, Liverpool L3 3AF, United Kingdom.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Lees', 'Affiliation': 'Faculty of Education, Health and Community, School of Nursing and Allied Health, Liverpool John Moores University, Byrom Street, Liverpool L3 3AF, United Kingdom.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Hollands', 'Affiliation': 'Research to Improve Stair Climbing Safety (RISCS), Faculty of Science, School of Sport and Exercise Sciences, Liverpool John Moores University, Byrom Street, Liverpool L3 3AF, United Kingdom.'}]",Experimental gerontology,['10.1016/j.exger.2020.110839']
586,32019123,"Influence of GDM Diagnosis and Treatment on Weight Gain, Dietary Intake and Physical Activity in Pregnant Women with Obesity: Secondary Analysis of the UPBEAT Study.","Obesity during pregnancy is associated with the development of gestational diabetes (GDM). This study aimed to assess if the result of an oral glucose tolerance test (OGTT) for GDM influences health (diet and physical activity) behaviours of pregnant women with obesity. In total, 1031 women who participated in the UK Pregnancies Better Eating and Activity Trial (UPBEAT) of a lifestyle intervention from early pregnancy were included. Changes in weight gain, dietary intake and physical activity following an OGTT undertaken between 27 +0  and 28 +6  weeks' and 34 and 36 weeks' gestation were examined using linear regression with appropriate adjustment for confounders. Obese women without GDM (IADPSG criteria) gained 1.9 kg (95% CI -2.2, -1.5,  p  < 0.001) more weight than women with GDM. Women with GDM demonstrated greater reductions in energy (-142kcal, 95%CI -242.2, -41.9,  p  = 0.006), carbohydrate intake (-1.5%E 95%CI -2.8, -0.3,  p  = 0.016) and glycaemic load (-15.2, 95%CI -23.6, -6.7,  p  < 0.001) and a greater increase in protein intake (2%E, 95%CI 1.3, 2.7,  p  < 0.001), compared to women without GDM. Trial intervention allocation did not influence any associations observed. The findings emphasise the need for strategies to optimise the health behaviours of pregnant women with obesity, following a negative OGTT for GDM.",2020,"Women with GDM demonstrated greater reductions in energy (-142kcal, 95%CI -242.2, -41.9,  p  = 0.006), carbohydrate intake (-1.5%E 95%CI -2.8, -0.3,  ","['pregnant women with obesity', 'Pregnant Women with Obesity', '1031 women who participated in the UK Pregnancies Better Eating and Activity Trial (UPBEAT) of a lifestyle intervention from early pregnancy were included']",['oral glucose tolerance test (OGTT'],"['weight gain, dietary intake and physical activity', 'carbohydrate intake', 'protein intake', 'glycaemic load', 'Weight Gain, Dietary Intake and Physical Activity', 'weight']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0332272', 'cui_str': 'Better (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}]","[{'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}]",1031.0,0.144125,"Women with GDM demonstrated greater reductions in energy (-142kcal, 95%CI -242.2, -41.9,  p  = 0.006), carbohydrate intake (-1.5%E 95%CI -2.8, -0.3,  ","[{'ForeName': ""La'Shay"", 'Initials': 'L', 'LastName': 'Atakora', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, WC1E 7HT, UK.'}, {'ForeName': 'Lucilla', 'Initials': 'L', 'LastName': 'Poston', 'Affiliation': ""Department of Women and Children's Health, King's College London, London, SE1 7EH, UK.""}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Hayes', 'Affiliation': 'Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, NE2 4AX, UK.'}, {'ForeName': 'Angela C', 'Initials': 'AC', 'LastName': 'Flynn', 'Affiliation': ""Department of Women and Children's Health, King's College London, London, SE1 7EH, UK.""}, {'ForeName': 'Sara L', 'Initials': 'SL', 'LastName': 'White', 'Affiliation': ""Department of Women and Children's Health, King's College London, London, SE1 7EH, UK.""}]",Nutrients,['10.3390/nu12020359']
587,32022887,Effect of Hydrocortisone vs Pasireotide on Pancreatic Surgery Complications in Patients With High Risk of Pancreatic Fistula: A Randomized Clinical Trial.,"Importance


Both hydrocortisone and pasireotide have been shown in randomized clinical trials to be effective in reducing postoperative complications of pancreatic surgery, but to date no randomized clinical trial has evaluated the effectiveness of pasireotide compared with hydrocortisone.
Objective


To assess the noninferiority of hydrocortisone compared with pasireotide in reducing complications after partial pancreatectomy.
Design, Setting, and Participants


A noninferiority, parallel-group, individually randomized clinical trial was conducted at a single academic center between May 19, 2016, and December 17, 2018. Outcome collectors and analyzers were blinded. A total of 281 patients undergoing partial pancreatectomy were assessed for inclusion. Patients younger than 18 years, those allergic to hydrocortisone or pasireotide, patients undergoing pancreaticoduodenectomy with hard pancreas or dilated pancreatic duct, and patients not eventually undergoing partial pancreatectomy were excluded. Modified intention-to-treat analysis was used in determination of the results.
Interventions


Treatment included pasireotide, 900 μg, subcutaneously twice a day for 7 days or hydrocortisone, 100 mg, intravenously 3 times a day for 3 days.
Main Outcomes and Measures


The primary outcome was the Comprehensive Complication Index (CCI) score within 30 days. The noninferiority limit was set to 9 CCI points.
Results


Of the 281 patients (mean [SD] age, 63.8 years) assessed for eligibility, 168 patients (mean [SD] age, 63.6 years) were randomized and 126 were included in the modified intention-to-treat analyses. Sixty-three patients received pasireotide (35 men [56%]; median [interquartile range] age, 64 [56-70] years) and 63 patients received hydrocortisone (25 men [40%]; median [interquartile range] age, 67 [56-73] years). The mean (SD) CCI score was 23.94 (17.06) in the pasireotide group and 30.11 (20.47) in the hydrocortisone group (mean difference, -6.16; 2-sided 90% CI, -11.73 to -0.60), indicating that hydrocortisone was not noninferior. Postoperative pancreatic fistula was detected in 34 patients (54%) in the pasireotide group and 39 patients (62%) in the hydrocortisone group (odds ratio, 1.39; 95% CI, 0.68-2.82; P = .37). One patient in the pasireotide group and 2 patients in the hydrocortisone group died within 30 days. In subgroup analyses of patients undergoing distal pancreatectomy, the CCI score was a mean of 10.3 points lower (mean [SD], 16.03 [11.94] vs 26.28 [21.76]; 2-sided 95% CI, -19.34 to -2.12; P = .03) and postoperative pancreatic fistula rate was lower (37% vs 67%; P = .02) in the pasireotide group compared with the hydrocortisone group.
Conclusions and Relevance


In this study, hydrocortisone was not noninferior compared with pasireotide in patients undergoing partial pancreatectomy. Pasireotide may be more effective than hydrocortisone in patients undergoing distal pancreatectomy.
Trial Registration


ClinicalTrials.gov identifier: NCT02775227; EudraCT identifier: 2016-000212-16.",2020,"The mean (SD) CCI score was 23.94 (17.06) in the pasireotide group and 30.11 (20.47) in the hydrocortisone group (mean difference, -6.16; 2-sided 90% CI, -11.73 to -0.60), indicating that hydrocortisone was not noninferior.","['281 patients (mean [SD] age, 63.8 years) assessed for eligibility, 168 patients (mean [SD] age, 63.6 years) were randomized and 126 were included in the modified intention-to-treat analyses', '25 men [40%]; median [interquartile range] age, 67 [56-73] years', '281 patients undergoing partial pancreatectomy were assessed for inclusion', 'patients undergoing partial pancreatectomy', 'Sixty-three patients received pasireotide (35 men [56%]; median [interquartile range] age, 64 [56-70] years) and 63 patients received', 'Patients younger than 18 years, those allergic to hydrocortisone or pasireotide, patients undergoing pancreaticoduodenectomy with hard pancreas or dilated pancreatic duct, and patients not eventually undergoing partial pancreatectomy were excluded', 'Patients', 'patients undergoing distal pancreatectomy', 'Pancreatic Fistula']","['hydrocortisone and pasireotide', 'pasireotide', 'Hydrocortisone vs Pasireotide', 'hydrocortisone']","['mean (SD) CCI score', 'postoperative pancreatic fistula rate', 'Postoperative pancreatic fistula', 'Comprehensive Complication Index (CCI) score', 'Pancreatic Surgery Complications', 'CCI score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4319556', 'cui_str': 'One hundred and sixty-eight'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0161912', 'cui_str': 'Partial pancreatectomy (procedure)'}, {'cui': 'C4319614', 'cui_str': '63 (qualifier value)'}, {'cui': 'C1872203', 'cui_str': 'pasireotide'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0085162', 'cui_str': 'Pancreatoduodenectomy'}, {'cui': 'C0018599', 'cui_str': 'Hardness'}, {'cui': 'C0030274', 'cui_str': 'Pancreas'}, {'cui': 'C0030288', 'cui_str': 'Pancreatic duct structure (body structure)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0176940', 'cui_str': 'Distal subtotal pancreatectomy (procedure)'}, {'cui': 'C0030290', 'cui_str': 'Pancreatic Fistula'}]","[{'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C1872203', 'cui_str': 'pasireotide'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0030290', 'cui_str': 'Pancreatic Fistula'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]",281.0,0.604697,"The mean (SD) CCI score was 23.94 (17.06) in the pasireotide group and 30.11 (20.47) in the hydrocortisone group (mean difference, -6.16; 2-sided 90% CI, -11.73 to -0.60), indicating that hydrocortisone was not noninferior.","[{'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Tarvainen', 'Affiliation': 'Department of Gastroenterological Surgery, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Jukka', 'Initials': 'J', 'LastName': 'Sirén', 'Affiliation': 'Department of Gastroenterological Surgery, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Arto', 'Initials': 'A', 'LastName': 'Kokkola', 'Affiliation': 'Department of Gastroenterological Surgery, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Ville', 'Initials': 'V', 'LastName': 'Sallinen', 'Affiliation': 'Department of Gastroenterological Surgery, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}]",JAMA surgery,['10.1001/jamasurg.2019.6019']
588,32157631,Cost-Effectiveness of Subsequent Whole-Brain Radiotherapy or Hippocampal-Avoidant Whole-Brain Radiotherapy Versus Stereotactic Radiosurgery or Surgery Alone for Treatment of Melanoma Brain Metastases.,"BACKGROUND


A randomized phase III trial comparing whole-brain radiotherapy (WBRT) to observation following definitive local treatment of intracranial melanoma metastases with neurosurgery and/or stereotactic surgery (SRS) is underway.
OBJECTIVE


We sought to assess the pre-trial cost-effectiveness of WBRT, hippocampal-avoidant WBRT (HA-WBRT), and observation (SRS or surgery alone) for this population to guide trial data collection efforts and reduce decision uncertainty.  METHODS: A time-dependent Markov model followed patients treated with neurosurgery or SRS who received subsequent WBRT, HA-WBRT or observation over a 5-year time horizon. Model inputs were sourced from published literature and results tested for robustness using probabilistic sensitivity analysis. Value of information (VOI) analysis was undertaken to guide data collection for the randomized trial.
RESULTS


Over 5 years, the WBRT strategy produced 1.74 QALYs (2.38 life-years) at a mean cost of $40,128 (costs in 2017 Australian dollars); HA-WBRT produced 1.88 QALYs (2.38 life-years) and cost $42,977; and SRS/surgery alone produced 1.65 QALYs (2.13 life-years) at a cost of $46,281. Probabilistic sensitivity analysis showed HA-WBRT was the preferred strategy in 77% of simulations. Cost-effectiveness results were most sensitive to utilities of the controlled-disease health state in the WBRT group, and costs of HA-WBRT. The EVPI for a randomized trial was estimated at $6,888 per person.
CONCLUSIONS


HA-WBRT may be cost-effective for the treatment of melanoma brain metastases. The results predicted in our model can be validated with prospective trial data when available.",2020,"Cost-effectiveness results were most sensitive to utilities of the controlled-disease health state in the WBRT group, and costs of HA-WBRT.","['intracranial melanoma metastases with', 'Melanoma Brain Metastases']","['neurosurgery and/or stereotactic surgery (SRS', 'WBRT, hippocampal-avoidant WBRT (HA-WBRT), and observation (SRS or surgery alone', 'Subsequent Whole-Brain Radiotherapy or Hippocampal-Avoidant Whole-Brain Radiotherapy Versus Stereotactic Radiosurgery or Surgery', 'whole-brain radiotherapy (WBRT']","['Cost-Effectiveness', 'costs of HA-WBRT']","[{'cui': 'C0524466', 'cui_str': 'Intracranial (qualifier value)'}, {'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0220650', 'cui_str': 'Secondary malignant neoplasm of brain (disorder)'}]","[{'cui': 'C0027926', 'cui_str': 'Neurosurgery'}, {'cui': 'C1735594', 'cui_str': 'Stereotactic surgery'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1520143', 'cui_str': 'Whole brain radiation therapy (regime/therapy)'}, {'cui': 'C3846112', 'cui_str': 'Radiosurgery, Stereotactic'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",,0.098716,"Cost-effectiveness results were most sensitive to utilities of the controlled-disease health state in the WBRT group, and costs of HA-WBRT.","[{'ForeName': 'Anh Dam', 'Initials': 'AD', 'LastName': 'Tran', 'Affiliation': 'Health Economics, National Drug and Alcohol Research Centre, University of New South Wales, 22-32 King street, Sydney, NSW, 2031, Australia. anh.tran@unsw.edu.au.'}, {'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'Fogarty', 'Affiliation': ""St Vincent's Department of Radiotherapy, St Vincent's Hospital, Darlinghurst, NSW, 2010, Australia.""}, {'ForeName': 'Anna K', 'Initials': 'AK', 'LastName': 'Nowak', 'Affiliation': 'Medical School, University of Western Australia, Crawley, WA, 6009, Australia.'}, {'ForeName': 'Vakaramoko', 'Initials': 'V', 'LastName': 'Diaby', 'Affiliation': 'Health Economics and Outcomes Research, Department of Pharmaceutical Outcomes and Policy (POP), College of Pharmacy, University of Florida, 1225 Center Drive, Gainesville, FL, 32610, USA.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Hong', 'Affiliation': 'Melanoma Institute Australia, University of Sydney, North Sydney, NSW, Australia.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Watts', 'Affiliation': 'Melanoma Institute Australia, University of Sydney, North Sydney, NSW, Australia.'}, {'ForeName': 'Rachael L', 'Initials': 'RL', 'LastName': 'Morton', 'Affiliation': 'Health Economics, National Drug and Alcohol Research Centre, University of New South Wales, 22-32 King street, Sydney, NSW, 2031, Australia.'}]",Applied health economics and health policy,['10.1007/s40258-020-00560-1']
589,31106492,Effectiveness of switching to very low nicotine content cigarettes plus nicotine patch versus reducing daily cigarette consumption plus nicotine patch to decrease dependence: an exploratory randomized trial.,"BACKGROUND AND AIMS


The United States Food and Drug Administration has proposed regulation to require that cigarettes contain very low nicotine content (VLNC). In contrast, reducing the number of cigarettes per day (CPD) is the most common current method to reduce nicotine. This trial aims to explore whether gradually transitioning to VLNC cigarettes plus nicotine patch or reducing CPD plus nicotine patch is more effective at decreasing nicotine dependence.
DESIGN


A two-arm, individually randomized open-label trial.
SETTING


Community setting, Vermont, USA.
PARTICIPANTS


Sixty-eight adult daily smokers (40% female) of ≥ 10 cigarettes/day who were not planning to quit in the next 30 days.
INTERVENTIONS


All participants smoked study cigarettes with a nicotine yield similar to most commercial cigarettes ad libitum for 1 week (baseline). Participants then gradually reduced to 70, 35, 15 and 3% of baseline nicotine over 4 weeks by either (a) transitioning to lower nicotine content cigarettes (n = 36) or (b) reducing the number of full nicotine cigarettes (n = 32). All participants received nicotine patches.
MEASUREMENTS


The primary outcome was change in nicotine dependence assessed at baseline and weekly during the intervention with the Nicotine Dependence Syndrome Scale.
FINDINGS


Dependence declined over time for both VLNC and CPD participants, but declined more for VLNC (mean decrease in Z-score of 1.0) than CPD (mean decrease in Z-score of 0.5) participants over time (interaction P = 0.018).
CONCLUSIONS


Transitioning to very low nicotine content cigarettes reduced nicotine dependence over a 4-week period to a greater extent than reducing cigarettes per day when both conditions were aided by nicotine patch.",2019,"FINDINGS


Dependence declined over time for both VLNC and CPD participants, but declined more for VLNC (mean decrease in Z-score of 1.0) than CPD (mean decrease in Z-score of 0.5) participants over time (interaction P = 0.018).
","['Participants then gradually reduced to 70, 35, 15 and 3% of baseline nicotine over 4\xa0weeks by either (a) transitioning to lower nicotine content cigarettes (n\xa0=\xa036) or (b) reducing the number of full nicotine cigarettes (n\xa0=\xa032', 'All participants smoked study cigarettes with a nicotine yield similar to most commercial cigarettes ad libitum for 1\xa0week (baseline', 'Sixty-eight adult daily smokers (40% female) of ≥\xa010 cigarettes/day who were not planning to quit in the next 30\xa0days']","['nicotine patch', 'switching to very low nicotine content cigarettes plus nicotine patch', 'nicotine patches', 'VLNC cigarettes plus nicotine patch', 'CPD plus nicotine patch']","['VLNC', 'number of cigarettes per day (CPD', 'nicotine dependence', 'Nicotine Dependence Syndrome Scale', 'change in nicotine dependence']","[{'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0450387', 'cui_str': '68 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1301732', 'cui_str': 'Planned'}]","[{'cui': 'C0358855', 'cui_str': 'Nicotine Transdermal Patch'}, {'cui': 'C0442811', 'cui_str': 'Very low (qualifier value)'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C2001794', 'cui_str': '(BMIM)(TFSI) cpd'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C2001794', 'cui_str': '(BMIM)(TFSI) cpd'}, {'cui': 'C0028043', 'cui_str': 'Nicotine Dependence'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0222045'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",68.0,0.0970918,"FINDINGS


Dependence declined over time for both VLNC and CPD participants, but declined more for VLNC (mean decrease in Z-score of 1.0) than CPD (mean decrease in Z-score of 0.5) participants over time (interaction P = 0.018).
","[{'ForeName': 'Elias M', 'Initials': 'EM', 'LastName': 'Klemperer', 'Affiliation': 'Vermont Center on Behavior and Health, Department of Psychiatry, University of Vermont, Burlington, VT, USA.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Hughes', 'Affiliation': 'Vermont Center on Behavior and Health, Department of Psychiatry, University of Vermont, Burlington, VT, USA.'}, {'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'Callas', 'Affiliation': 'Department of Biostatistics, University of Vermont, Burlington, VT, USA.'}, {'ForeName': 'Joy A', 'Initials': 'JA', 'LastName': 'Benner', 'Affiliation': 'Vermont Center on Behavior and Health, Department of Psychiatry, University of Vermont, Burlington, VT, USA.'}, {'ForeName': 'Nicholas E', 'Initials': 'NE', 'LastName': 'Morley', 'Affiliation': 'Vermont Center on Behavior and Health, Department of Psychiatry, University of Vermont, Burlington, VT, USA.'}]","Addiction (Abingdon, England)",['10.1111/add.14666']
590,31286906,A pragmatic randomised trial of two counselling models at the Swedish national alcohol helpline.,"BACKGROUND


Alcohol telephone helplines targeting alcohol consumers in the general population can extend the reach of brief interventions while preserving in-person counselling. So far, studies of client outcomes in the setting of alcohol helplines are scarce. This study aims to compare the 6-months alcohol-related outcomes of two counselling models delivered at the Swedish National Alcohol Helpline.
METHODS


A pragmatic randomised trial was set up at the Swedish National Alcohol Helpline. First-time callers with current hazardous or harmful alcohol use who contacted the helpline, from May 2015 to December 2017, were invited to participate. Clients were allocated with 1:1 ratio to two groups: (1) brief, structured intervention (n = 128), including self-help material and one counsellor-initiated call, and (2) usual care (n = 133), i.e. multiple-session counselling using Motivational Interviewing (MI). The primary outcome was a downward change in AUDIT risk-zone between baseline and 6-months follow-up. The analysis followed an intention-to-treat approach.
RESULTS


Recruitment ended in December 2017. At 6-months follow-up, 70% of the enrolled participants had data on the outcome. In the brief, structured intervention (n = 107) 68% changed to a lower risk-level, compared to 61% in the usual care group (n = 117), yielding a risk ratio (RR) of 1.12 (95% CI 0.93 to 1.37) and risk difference of 0.08 (95% CI -0.05 to 0.20). The total AUDIT score and the scores from the AUDIT consumption questions (AUDIT-C) did not reveal any between-group differences in the mean change at follow-up.
CONCLUSIONS


The counselling at the Swedish National Alcohol Helpline was followed by a significant decrease in alcohol use among clients, without clear superiority for either counselling model.
TRIAL REGISTRATION


This trial was retrospectively registered with ISRCNT.com (ID: ISRCTN13160878 ) 18/01/2016.",2019,"The counselling at the Swedish National Alcohol Helpline was followed by a significant decrease in alcohol use among clients, without clear superiority for either counselling model.
","['two counselling models at the Swedish national alcohol helpline', 'Swedish National Alcohol Helpline', 'First-time callers with current hazardous or harmful alcohol use who contacted the helpline, from May 2015 to December 2017, were invited to participate']","['structured intervention (n\xa0=\u2009128), including self-help material and one counsellor-initiated call, and (2) usual care (n\xa0=\u2009133), i.e. multiple-session counselling using Motivational Interviewing (MI']",['downward change in AUDIT risk-zone'],"[{'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}]","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0683474', 'cui_str': 'Motivational Interviewing'}]","[{'cui': 'C0205104', 'cui_str': 'Down (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",,0.109609,"The counselling at the Swedish National Alcohol Helpline was followed by a significant decrease in alcohol use among clients, without clear superiority for either counselling model.
","[{'ForeName': 'Eleonor', 'Initials': 'E', 'LastName': 'Säfsten', 'Affiliation': 'Department of Public Health Sciences, Karolinska Institutet, 171 77, Stockholm, Sweden. eleonor.safsten@ki.se.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Forsell', 'Affiliation': 'Department of Public Health Sciences, Karolinska Institutet, 171 77, Stockholm, Sweden.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Ramstedt', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, 171 77, Stockholm, Sweden.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Damström Thakker', 'Affiliation': 'Centre for Epidemiology and Community Medicine, Stockholm Health Care District, Stockholm County Council, 104 31, Stockholm, Sweden.'}, {'ForeName': 'Maria Rosaria', 'Initials': 'MR', 'LastName': 'Galanti', 'Affiliation': 'Department of Public Health Sciences, Karolinska Institutet, 171 77, Stockholm, Sweden.'}]",BMC psychiatry,['10.1186/s12888-019-2199-z']
591,32152868,Brief Behavioral Therapy for Insomnia in Patients with Irritable Bowel Syndrome: A Pilot Study.,"BACKGROUND


Up to 60% of patients with irritable bowel syndrome (IBS) report fatigue and 50% meet criteria for clinical insomnia. Recent studies have demonstrated a relationship between poor sleep and next-day IBS symptoms. However, no study to-date has evaluated behavioral therapy to treat poor sleep in IBS.
AIMS


The aim of the current pilot study is to test feasibility of behavioral therapy for insomnia among patients with IBS and poor sleep.
METHODS


This randomized controlled pilot study tested the feasibility of administering brief behavioral therapy for insomnia (BBT-I) to patients with IBS who report poor sleep. Participants were randomized to BBT-I or self-monitoring control. Exploratory analyses evaluated group differences after 4 weeks of treatment.
RESULTS


A total of 25 participants were randomized to the study, 13 to BBT-I and 12 to the control group. Three participants dropped out of the treatment group. Satisfaction with treatment was high. At follow-up, there were significant differences between groups in measures of sleep quality and insomnia severity. There were trends toward significance in IBS severity score, with 40% of the BBT-I sample reporting clinically meaningful drop in symptoms compared to 17% of the control group. Similar trends were observed with belly pain and global improvement scores.
CONCLUSIONS


This pilot study demonstrates feasibility/acceptability of a brief behavioral therapy for patients with IBS and poor sleep. Additionally, this study provides preliminary evidence to suggest that treatment of sleep difficulties in patients with IBS may improve IBS symptom outcomes. Future, larger randomized controlled studies are needed.",2020,"At follow-up, there were significant differences between groups in measures of sleep quality and insomnia severity.","['patients with IBS and poor sleep', 'Patients with Irritable Bowel Syndrome', 'patients with IBS', 'patients with IBS who report poor sleep', 'A total of 25 participants were randomized to the study, 13 to BBT-I and 12 to the control group']","['Brief Behavioral Therapy', 'BBT-I or self-monitoring control', 'behavioral therapy']","['sleep quality and insomnia severity', 'belly pain and global improvement scores', 'IBS symptom outcomes', 'IBS severity score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0235162', 'cui_str': 'Difficulty sleeping (finding)'}, {'cui': 'C0022104', 'cui_str': 'Irritable Bowel Syndrome'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0004933', 'cui_str': 'Behavior Modification'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0457451', 'cui_str': 'Severity score (qualifier value)'}]",25.0,0.0298679,"At follow-up, there were significant differences between groups in measures of sleep quality and insomnia severity.","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Ballou', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston, MA, USA. sballou@bidmc.harvard.edu.'}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Katon', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Vikram', 'Initials': 'V', 'LastName': 'Rangan', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Vivian', 'Initials': 'V', 'LastName': 'Cheng', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Nee', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Iturrino', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Lembo', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}]",Digestive diseases and sciences,['10.1007/s10620-020-06182-w']
592,31462695,Effects of cognitive behavioral therapy on weight maintenance after successful weight loss in women; a randomized clinical trial.,"BACKGROUND/OBJECTIVES


Weight regain after weight loss is a main challenge in obesity management. Cognitive behavioral therapy (CBT) has been introduced as an option for achieving weight loss but not tested for weight maintenance. The aim of this study was to evaluate the effects of CBT on weight maintenance after successful weight loss.
SUBJECTS/METHODS


Female adults [n = 113, BMI = 23-30 kg/m²; age = 18-45 years], who had lost at least 10% of their body weight by using a weight loss program, were randomly allocated to either CBT or control group for a further 24-week weight-maintenance period.
RESULTS


Compared with control group, CBT treatment improved weight loss maintenance (mean difference, -2.2 kg [95% CI, -3.50, -0.94]; P = 0.001), BMI (mean difference, -0.77 kg/m²; [95% CI, -1.25, -0.28]; P = 0.002), and waist circumference (mean difference, -2.08 cm; [95% CI, -3.31, -0.844]; P = 0.001) at the end of the 24-week period intervention. Estimated energy intake showed a significant reduction over time in CBT group, while it increased in control group (P < 0.001). There was also a significant group × time interaction for mean daily steps over the 24-week period with CBT having a higher level (P < 0.001). However, changes in lipid profiles and carbohydrate metabolism were not significantly different between the groups.
CONCLUSION


Cognitive behavioral therapy is an effective tool for weight maintenance over a 24-week period in successful weight losers, with corresponding maintenance of a reduced energy intake and doing more physical activity which may helpful for weight maintenance in the long term.",2020,"Compared with control group, CBT treatment improved weight loss maintenance (mean difference, -2.2 kg [95% CI, -3.50, -0.94]; P = 0.001), BMI (mean difference, -0.77 kg/m²; [95% CI, -1.25, -0.28]; P = 0.002), and waist circumference (mean difference, -2.08 cm; [95% CI, -3.31, -0.844]; P = 0.001) at the end of the 24-week period intervention.","['Female adults [n\u2009', 'women', '113, BMI\u2009=\u200923-30\u2009kg/m²; age\u2009=\u200918-45 years], who had lost at least 10% of their body weight by using a weight loss program']","['CBT', 'cognitive behavioral therapy', 'Cognitive behavioral therapy (CBT', 'Cognitive behavioral therapy']","['weight maintenance', 'weight loss', 'weight loss maintenance', 'BMI', 'lipid profiles and carbohydrate metabolism', 'waist circumference']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C3179079', 'cui_str': 'Weight Loss Programs'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0302820', 'cui_str': 'Carbohydrate Metabolism'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}]",,0.0556818,"Compared with control group, CBT treatment improved weight loss maintenance (mean difference, -2.2 kg [95% CI, -3.50, -0.94]; P = 0.001), BMI (mean difference, -0.77 kg/m²; [95% CI, -1.25, -0.28]; P = 0.002), and waist circumference (mean difference, -2.08 cm; [95% CI, -3.31, -0.844]; P = 0.001) at the end of the 24-week period intervention.","[{'ForeName': 'Ameneh', 'Initials': 'A', 'LastName': 'Madjd', 'Affiliation': 'MRC/ARUK Centre for Musculoskeletal Ageing Research, National Institute for Health Research (NIHR) Nottingham Biomedical Research Centre, School of Life Sciences, University of Nottingham Medical School, Nottingham, NG7 2UH, UK. ameneh.madjd@nottingham.ac.uk.'}, {'ForeName': 'Moira A', 'Initials': 'MA', 'LastName': 'Taylor', 'Affiliation': 'MRC/ARUK Centre for Musculoskeletal Ageing Research, National Institute for Health Research (NIHR) Nottingham Biomedical Research Centre, School of Life Sciences, University of Nottingham Medical School, Nottingham, NG7 2UH, UK.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Delavari', 'Affiliation': 'Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Malekzadeh', 'Affiliation': 'Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ian A', 'Initials': 'IA', 'LastName': 'Macdonald', 'Affiliation': 'MRC/ARUK Centre for Musculoskeletal Ageing Research, National Institute for Health Research (NIHR) Nottingham Biomedical Research Centre, School of Life Sciences, University of Nottingham Medical School, Nottingham, NG7 2UH, UK.'}, {'ForeName': 'Hamid R', 'Initials': 'HR', 'LastName': 'Farshchi', 'Affiliation': 'MRC/ARUK Centre for Musculoskeletal Ageing Research, National Institute for Health Research (NIHR) Nottingham Biomedical Research Centre, School of Life Sciences, University of Nottingham Medical School, Nottingham, NG7 2UH, UK. hamid.farshchi@nottingham.ac.uk.'}]",European journal of clinical nutrition,['10.1038/s41430-019-0495-9']
593,31668861,Positive-pressure needleless connectors did not increase rates of catheter hub colonization respecting the use of neutral-pressure needleless connectors in a prospective randomized trial.,"INTRODUCTION


The aim of this study was to compare the colonization rates of central venous catheter (CVC) and arterial catheter (ArtC) hubs fitted with two types of needleless connectors (NCs).
METHODS


We designed a prospective randomized study to compare rates of catheter hub colonization of CVC and ArtC hubs fitted with two types of needleless connectors: neutral-pressure NCs (NP-NCs) and positive-pressure NCs (PP-NCs) in critically ill patients. All NCs were replaced every 7 days of use.
RESULTS


We obtained 326 cultures from 146 catheters (81 CVC and 65 ArtC) in 70 patients. The total cumulative days of risk were 1250 catheter-days. Global swab cultures were positive in NP-NCs in 29/198 (14.6%) versus 17/128 (13.3%) in PP-NCs during catheter use. We did not observe any cases of CRBSI.
CONCLUSIONS


In our experience, the use of PP-NCs did not result in significantly more frequent hub colonization with respect to NP-NCs.",2020,"In our experience, the use of PP-NCs did not result in significantly more frequent hub colonization with respect to NP-NCs.","['critically ill patients', '326 cultures from 146 catheters (81 CVC and 65 ArtC) in 70 patients']","['CVC and ArtC hubs fitted with two types of needleless connectors: neutral-pressure NCs (NP-NCs) and positive-pressure NCs (PP-NCs', 'central venous catheter (CVC) and arterial catheter (ArtC']",['total cumulative days of risk'],"[{'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0220814', 'cui_str': 'culture'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}]","[{'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1145640', 'cui_str': 'Central Venous Catheters'}, {'cui': 'C0581447', 'cui_str': 'Arterial catheter (physical object)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",1250.0,0.0792505,"In our experience, the use of PP-NCs did not result in significantly more frequent hub colonization with respect to NP-NCs.","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Delgado', 'Affiliation': 'Internal Medicine Service, Hospital de Mataró, Mataró, Barcelona, Spain; Department of Medicine, Universitat Autònoma de Barcelona, Spain. Electronic address: mdelgadoca@csdm.cat.'}, {'ForeName': 'Josep A', 'Initials': 'JA', 'LastName': 'Capdevila', 'Affiliation': 'Internal Medicine Service, Hospital de Mataró, Mataró, Barcelona, Spain; Department of Medicine, Universitat Autònoma de Barcelona, Spain.'}, {'ForeName': 'Goretti', 'Initials': 'G', 'LastName': 'Sauca', 'Affiliation': 'Microbiology Service, Hospital de Mataró, Mataró, Barcelona, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Méndez', 'Affiliation': 'Intensive Care Unit, Hospital de Mataró, Mataró, Barcelona, Spain.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Rodriguez', 'Affiliation': 'Critical Care Department, Hospital Universitari Joan XXIII, Tarragona, Spain.'}, {'ForeName': 'Juan Carlos', 'Initials': 'JC', 'LastName': 'Yébenes', 'Affiliation': 'Intensive Care Unit, Hospital de Mataró, Mataró, Barcelona, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Enfermedades infecciosas y microbiologia clinica,['10.1016/j.eimc.2019.07.012']
594,32152738,Preoperative ankle block for postoperative analgesia in foot surgery.,"BACKGROUND


The use of a tourniquet and patients' preference for general anesthesia (GA) limit performing ankle blocks (AB) as a sole anesthetic technique for orthopedic foot surgery. The aim of this prospective and randomized study was to test the hypothesis that administration of an AB before GA could be effective for postoperative pain relief in patients undergoing outpatient hallux valgus surgery. Primary outcome measure was mean pain score and secondary outcome measures were time to mobilization of patients, time to hospital discharge, and complications.
METHODS


A total of 110 adult patients were randomly assigned into two groups: group GA (n = 55) and group GA + AB (n = 55). Group GA + AB received an AB using 100 mg lidocaine 2% and 75 mg bupivacaine 0.5% before the induction of GA. Pain intensity was evaluated using a visual analogue scale (VAS).
RESULTS


Mean VAS scores were higher and times to first rescue analgesic were shorter in group GA compared to group GA + AB (p = 0.001). More patients required rescue analgesic in group GA and pethidine consumption was higher (p = 0.001). Time to mobilization was shorter in GA + AB group (p = 0.001) but hospital discharge time was similar between groups (p = 0.269). The incidence of nausea and vomiting was higher in group GA (p = 0.002).
CONCLUSION


Ankle block is an effective and simple technique for reducing postoperative pain and opioid consumption. It reduced the time to mobilization without a delay in hospital discharge. It is concluded that the routine administration of AB before GA may be an effective and simple method for pain relief after foot surgery.",2020,"RESULTS


Mean VAS scores were higher and times to first rescue analgesic were shorter in group GA compared to group GA + AB (p = 0.001).","['110 adult patients', 'foot\xa0surgery', 'patients undergoing outpatient hallux valgus surgery']","['general anesthesia (GA) limit performing ankle blocks (AB', 'AB before GA', 'bupivacaine', 'lidocaine']","['postoperative pain relief', 'postoperative pain and opioid consumption', 'Mean VAS scores', 'hospital discharge time', 'pethidine consumption', 'Time to mobilization', 'pain relief', 'Pain intensity', 'nausea and vomiting', 'mean pain score', 'time to mobilization of patients, time to hospital discharge, and complications', 'visual analogue scale (VAS']","[{'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0188413', 'cui_str': 'Operative procedure on foot'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0158458', 'cui_str': 'Acquired hallux valgus (disorder)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0394745', 'cui_str': 'Local anesthetic ankle block (procedure)'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}]","[{'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0025376', 'cui_str': 'pethidine'}, {'cui': 'C0300926', 'cui_str': 'mobilization'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",110.0,0.125225,"RESULTS


Mean VAS scores were higher and times to first rescue analgesic were shorter in group GA compared to group GA + AB (p = 0.001).","[{'ForeName': 'Mehmet Özgür', 'Initials': 'MÖ', 'LastName': 'Özhan', 'Affiliation': 'Department of Anesthesiology and Reanimation, Private Çankaya Hospital, Barbaros Mah. Bülten Sok. No.\xa044, 06500, Çankaya/Ankara, Turkey. metozhan2003@yahoo.com.'}, {'ForeName': 'Altuğ', 'Initials': 'A', 'LastName': 'Tanrıöver', 'Affiliation': 'Department of Orthopedics and Traumatology, Private Çankaya Hospital, Ankara, Turkey.'}, {'ForeName': 'Bülent', 'Initials': 'B', 'LastName': 'Atik', 'Affiliation': 'Department of Anesthesiology and Reanimation, Balıkesir University Medical School, Balıkesir, Turkey.'}, {'ForeName': 'Ceyda', 'Initials': 'C', 'LastName': 'Özhan Çaparlar', 'Affiliation': 'Department of Anesthesiology and Reanimation, University of Medical Sciences, Yıldırım Beyazıt Education and Research Hospital, Ankara, Turkey.'}, {'ForeName': 'Burak Mehmet', 'Initials': 'BM', 'LastName': 'Eşkin', 'Affiliation': 'Department of Anesthesiology and Reanimation, University of Medical Sciences, Gülhane Education and Research Hospital, Ankara, Turkey.'}, {'ForeName': 'Anıl Mehmet', 'Initials': 'AM', 'LastName': 'Süzer', 'Affiliation': 'Department of Anesthesiology and Reanimation, Private Çankaya Hospital, Barbaros Mah. Bülten Sok. No.\xa044, 06500, Çankaya/Ankara, Turkey.'}]",Der Anaesthesist,['10.1007/s00101-020-00754-1']
595,30701596,Understanding adolescent and parent acceptability and feasibility experience in a large Type 1 diabetes mellitus behavioural trial.,"AIMS


Using an 18-month, multisite randomized control trial as an exemplar, the aim of this study was to identify themes related to adolescent and parental feasibility and acceptability for participation in large behavioural trials designed to improve adolescents' Type 1 diabetes self-management.
METHODS


Thematic analysis methodology was used to develop themes describing factors related to acceptability and feasibility.
RESULTS


Based on a sample of interviews (N = 72), factors contributing to intervention acceptability and feasibility were identified. Aspects of acceptability included: a framework for goal-setting, the coach as a non-judgemental listener, perception of an ongoing benefit to participation and the delivery mode. Aspects of feasibility included: participants' altruism to help adolescents with Type 1 diabetes; pre-enrolment preparation for intervention content and duration; and the option of remote intervention delivery via telephone or video, which minimized travel time and costs. In addition, participants described positive outcomes including improvements in behaviour, Type 1 diabetes self-management behaviours and parent-adolescent communication, and emotion-attitude changes. Participants also described potential revisions that may inform future trials.
CONCLUSIONS


Acceptability and feasibility of behavioural interventions with adolescents with chronic illness have multifactorial dimensions. While empowering adolescent self-management, parental support is also an under-appreciated aspect to consider. Potential revisions were identified for subsequent behavioural trials.",2020,"In addition, participants described positive outcomes including improvements in behaviour, Type 1 diabetes self-management behaviours and parent-adolescent communication, and emotion-attitude changes.","[""adolescents' Type 1 diabetes self-management"", "" participants' altruism to help adolescents with Type 1 diabetes"", 'adolescents with chronic illness']",['behavioural interventions'],"['behaviour, Type 1 diabetes self-management behaviours and parent-adolescent communication, and emotion-attitude changes']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0002357', 'cui_str': 'Altruism'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0008679', 'cui_str': 'Chronic Illness'}]",[],"[{'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0235187', 'cui_str': 'Attitude changed'}]",,0.0565679,"In addition, participants described positive outcomes including improvements in behaviour, Type 1 diabetes self-management behaviours and parent-adolescent communication, and emotion-attitude changes.","[{'ForeName': 'D H', 'Initials': 'DH', 'LastName': 'Grossoehme', 'Affiliation': 'Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Smith', 'Affiliation': ""Divisions of Endocrinology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH.""}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Standiford', 'Affiliation': ""Divisions of Endocrinology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH.""}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Morwessel', 'Affiliation': ""Divisions of Endocrinology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Kichler', 'Affiliation': 'Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH.'}, {'ForeName': 'D M', 'Initials': 'DM', 'LastName': 'Maahs', 'Affiliation': 'Division of Pediatric Endocrinology, Stanford University, Stanford, CA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Driscoll', 'Affiliation': ""Department of Pediatrics, Barbara Davis Center for Childhood Diabetes, The Children's Hospital of Colorado, Aurora, CO.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Seid', 'Affiliation': 'Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH.'}]",Diabetic medicine : a journal of the British Diabetic Association,['10.1111/dme.13913']
596,31399446,"Effectiveness and safety of Chinese herbal medicine xuanbi antong granules for the treatment of borderline coronary lesions: study protocol for a randomised, double-blinded, placebo-controlled, multicentre clinical trial.","INTRODUCTION


As the early stage of coronary heart disease (CHD), borderline coronary lesion (BCL) is defined as a 30%-70% diameter stenosis. Previous studies have demonstrated that BCL may progress to acute coronary syndrome easily. However, routine medications available for the treatments of BCL have some limitations. Xuanbi antong granule (XAG) has been used for the treatment of BCL in China for many years. Previous studies have shown that XAG has effectiveness in improving clinical symptoms and quality of life in patients with CHD. This study aims to evaluate the effectiveness and safety of XAG in patients with BCL.
METHODS AND ANALYSIS


This is a multicentre, randomised, double-blinded, placebo-controlled clinical trial. A total of 300 participants will be randomly assigned to the intervention group and the placebo group. Based on routine medications, the intervention group will be treated with XAG and the placebo group will be treated with XAG placebo. All participants will receive a 6-month treatment and then be followed-up for another 6 months. The primary outcomes are the changes of target plaque characteristics (including target plaque volume, degree of stenosis, CT value and calcification score) measured by dual source CT angiography. The secondary outcomes include blood lipid indicators, efficacy of angina symptoms, Seattle Angina Questionnaire, high-sensitivity C-reactive protein and occurrence of major adverse cardiac events. All the data will be recorded in electronic case report forms and analysed by SPSS V.20.0.
ETHICS AND DISSEMINATION


This study has been approved by Research Ethics Committee of Guang'anmen Hospital, China Academy of Chinese Medical Sciences in Beijing, China (No. 2017-083-KY-01). Written informed consent will be obtained from all participants. The results of this study will be disseminated to the public through academic conferences and peer-reviewed journals.
TRIAL REGISTRATION NUMBER


ChiCTR-IOR-17013189; Pre-results.",2019,Xuanbi antong granule (XAG) has been used for the treatment of BCL in China for many years.,"['300 participants', 'patients with BCL', 'patients with CHD', 'borderline coronary lesions']","['XAG', 'placebo', 'XAG placebo', 'Xuanbi antong granule (XAG', 'Chinese herbal medicine xuanbi antong granules', 'BCL']","['blood lipid indicators, efficacy of angina symptoms, Seattle Angina Questionnaire, high-sensitivity C-reactive protein and occurrence of major adverse cardiac events', 'Effectiveness and safety', 'changes of target plaque characteristics (including target plaque volume, degree of stenosis, CT value and calcification score', 'clinical symptoms and quality of life']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3853573', 'cui_str': 'Granules'}, {'cui': 'C1273412', 'cui_str': 'Chinese herbal medicine'}]","[{'cui': 'C0005768'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0002962', 'cui_str': 'Stenocardia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C1261287', 'cui_str': 'Stenosis'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0034380'}]",300.0,0.408143,Xuanbi antong granule (XAG) has been used for the treatment of BCL in China for many years.,"[{'ForeName': 'Mingyan', 'Initials': 'M', 'LastName': 'Huang', 'Affiliation': ""Department of Cardiology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Guang', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': ""Department of Cardiology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Qingya', 'Initials': 'Q', 'LastName': 'Guan', 'Affiliation': 'Graduate School, Hubei University of Chinese Medicine, Wuhan, China.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': ""Department of Cardiology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Zhao', 'Affiliation': ""Department of Radiology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ""Department of Cardiology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Kuiwu', 'Initials': 'K', 'LastName': 'Yao', 'Affiliation': ""Department of Cardiology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Zhenpeng', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': ""Department of Cardiology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Haoqiang', 'Initials': 'H', 'LastName': 'He', 'Affiliation': ""Department of Cardiology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, Yunnan Provincial Hospital of Traditional Chinese Medicine, Kunming, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Lin', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital of Xinxiang Medical University, Xinxiang, China.'}, {'ForeName': 'Xinhui', 'Initials': 'X', 'LastName': 'He', 'Affiliation': 'Department of Cardiology, Yunnan Provincial Hospital of Traditional Chinese Medicine, Kunming, China.'}, {'ForeName': 'Yongmei', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Molecular Biology Laboratory, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Xing-Jiang', 'Initials': 'XJ', 'LastName': 'Xiong', 'Affiliation': ""Department of Cardiology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Yuqing', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Clinicial Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Han', 'Affiliation': 'Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Department of Cardiology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.""}]",BMJ open,['10.1136/bmjopen-2018-024968']
597,31806610,NINJA trial: should the nail plate be replaced or discarded after nail bed repair in children? Protocol for a multicentre randomised control trial.,"INTRODUCTION


Trauma to the nail bed is the most common surgically treated paediatric hand injury. The majority of surgeons replace the nail plate after repairing the nail bed despite a lack of evidence to do so. Replacing the nail plate may be associated with increased postoperative infection. We will investigate the impact of replacing or discarding the nail plate on infection, cosmetic appearance, pain and subsequent healthcare use. The Nail bed INJury Analysis trial (NINJA) aims to answer the question of whether the nail plate should be replaced or discarded after surgical nail bed repair in children.
METHODS AND ANALYSIS


A two-arm parallel group open multicentre randomised control trial of replacing the nail plate or not, as part of a nail bed repair, will be undertaken in children presenting within 48 hours of a nail bed injury requiring surgical repair. The coprimary outcomes are: cosmetic appearance summary score at a minimum of 4 months and surgical site infection at around 7 days following surgery. Secondary outcomes are EuroQol EQ-5D-(Y); the pain intensity experienced at first dressing change; child/parent satisfaction with nail healing and healthcare resource use. We will recruit a minimum of 416 patients (208 in each group) over 3 years. Children and their parents/carers will be reviewed in clinic around 7 days after their operation and will be assessed for surgical site infection or other problems. The children, or depending on age, their parents/carers, will also be asked to complete a questionnaire and send in photos of their fingernail at a minimum of 4 months postsurgery to assess cosmetic appearance.
ETHICS AND DISSEMINATION


The South Central Research Ethics Committee approved this study on 4 June 2019 (18/SC/0024). A manuscript to a peer-reviewed journal will be submitted on completion of the trial as per National Institute for Health Research publication policy. The results of this trial will substantially inform clinical practice and provide evidence on whether the practice of replacing the nail plate should continue at the time of nail bed repair.
TRIAL REGISTRATION NUMBER


ISRCTN44551796.",2019,The coprimary outcomes are: cosmetic appearance summary score at a minimum of 4 months and surgical site infection at around 7 days following surgery.,"['416 patients (208 in each group) over 3 years', '4 June 2019 (18/SC/0024', 'children presenting within 48\u2009hours of a nail bed injury requiring surgical repair']","['nail plate or not, as part of a nail bed repair']","['EuroQol EQ-5D-(Y); the pain intensity experienced at first dressing change; child/parent satisfaction with nail healing and healthcare resource use', 'cosmetic appearance summary score at a minimum of 4 months and surgical site infection', 'postoperative infection']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0439586', 'cui_str': '48 hours (qualifier value)'}, {'cui': 'C1735595', 'cui_str': 'Nail bed injury'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}]","[{'cui': 'C0027342', 'cui_str': 'Nails'}, {'cui': 'C0407295', 'cui_str': 'Fixation of fracture using plate (procedure)'}, {'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C0221997', 'cui_str': 'Nail bed structure'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}]","[{'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0085671', 'cui_str': 'Dressing change'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0027342', 'cui_str': 'Nails'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0442965', 'cui_str': 'Cosmetic procedure (qualifier value)'}, {'cui': 'C0700364', 'cui_str': 'Appearances (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0038941', 'cui_str': 'Postoperative Wound Infection'}, {'cui': 'C0392618', 'cui_str': 'Postoperative infection (disorder)'}]",416.0,0.139695,The coprimary outcomes are: cosmetic appearance summary score at a minimum of 4 months and surgical site infection at around 7 days following surgery.,"[{'ForeName': 'Abhilash', 'Initials': 'A', 'LastName': 'Jain', 'Affiliation': 'Department of Plastic Surgery, Imperial College Healthcare NHS Trust, London, United Kingdom.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Jones', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Gardiner', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom matthew.gardiner@kennedy.ox.ac.uk.'}, {'ForeName': 'Cushla', 'Initials': 'C', 'LastName': 'Cooper', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Sierakowski', 'Affiliation': ""St Andrew's Centre for Plastic Surgery and Burns, Mid Essex Hospital Services NHS Trust, Chelmsford, United Kingdom.""}, {'ForeName': 'Melina', 'Initials': 'M', 'LastName': 'Dritsaki', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'May Ee', 'Initials': 'ME', 'LastName': 'Png', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Jamie R', 'Initials': 'JR', 'LastName': 'Stokes', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Beverly', 'Initials': 'B', 'LastName': 'Shirkey', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Cook', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Beard', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Aina V H', 'Initials': 'AVH', 'LastName': 'Greig', 'Affiliation': ""Department of Plastic and Reconstructive Surgery, Guy's and St Thomas' NHS Foundation Trust, London, United Kingdom.""}]",BMJ open,['10.1136/bmjopen-2019-031552']
598,31720722,Physiotherapy rehabilitation for osteoporotic vertebral fracture-a randomised controlled trial and economic evaluation (PROVE trial).,"The trial compared three physiotherapy approaches: manual or exercise therapy compared with a single session of physiotherapy education (SSPT) for people with osteoporotic vertebral fracture(s). At 1 year, there were no statistically significant differences between the groups meaning there is inadequate evidence to support manual or exercise therapy.
INTRODUCTION


To evaluate the clinical and cost-effectiveness of different physiotherapy approaches for people with osteoporotic vertebral fracture(s) (OVF).
METHODS


>Prospective, multicentre, adaptive, three-arm randomised controlled trial. Six hundred fifteen adults with back pain, osteoporosis, and at least 1 OVF participated.
INTERVENTIONS


7 individual physiotherapy sessions over 12 weeks focused on either manual therapy or home exercise compared with a single session of physiotherapy education (SSPT). The co-primary outcomes were quality of life and back muscle endurance measured by the QUALEFFO-41 and timed loaded standing (TLS) test at 12 months.
RESULTS


At 12 months, there were no statistically significant differences between groups. Mean QUALEFFO-41: - 1.3 (exercise), - 0.15 (manual), and - 1.2 (SSPT), a mean difference of - 0.2 (95% CI, - 3.2 to 1.6) for exercise and 1.3 (95% CI, - 1.8 to 2.9) for manual therapy. Mean TLS: 9.8 s (exercise), 13.6 s (manual), and 4.2 s (SSPT), a mean increase of 5.8 s (95% CI, - 4.8 to 20.5) for exercise and 9.7 s (95% CI, 0.1 to 24.9) for manual therapy. Exercise provided more quality-adjusted life years than SSPT but was more expensive. At 4 months, significant changes above SSPT occurred in endurance and balance in manual therapy, and in endurance for those ≤ 70 years, in balance, mobility, and walking in exercise.
CONCLUSIONS


Adherence was problematic. Benefits at 4 months did not persist and at 12 months, we found no significant differences between treatments. There is inadequate evidence a short physiotherapy intervention of either manual therapy or home exercise provides long-term benefits, but arguably short-term benefits are valuable.
TRIAL REGISTRATION


ISRCTN 49117867.",2020,"At 1 year, there were no statistically significant differences between the groups meaning there is inadequate evidence to support manual or exercise therapy.
","['Six hundred fifteen adults with back pain, osteoporosis, and at least 1 OVF participated', 'people with osteoporotic vertebral fracture(s', 'people with osteoporotic vertebral fracture(s) (OVF']","['physiotherapy approaches: manual or exercise therapy compared with a single session of physiotherapy education (SSPT', 'Physiotherapy rehabilitation', 'manual therapy or home exercise compared with a single session of physiotherapy education (SSPT', 'physiotherapy approaches']","['quality of life and back muscle endurance measured by the QUALEFFO-41 and timed loaded standing (TLS) test', 'balance, mobility, and walking in exercise', 'quality-adjusted life years']","[{'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0080179', 'cui_str': 'Spinal Fractures'}]","[{'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0452240', 'cui_str': 'Rehabilitation Exercise'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0454525', 'cui_str': 'Manual Therapies'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0034380'}, {'cui': 'C0224334', 'cui_str': 'Back Muscles'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0080071', 'cui_str': 'QALY'}]",615.0,0.185415,"At 1 year, there were no statistically significant differences between the groups meaning there is inadequate evidence to support manual or exercise therapy.
","[{'ForeName': 'K L', 'Initials': 'KL', 'LastName': 'Barker', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS), Botnar Research Centre, University of Oxford, Oxford, OX3 7LD, UK. karen.barker@ouh.nhs.uk.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Newman', 'Affiliation': 'Physiotherapy Research Unit, Physiotherapy Department, Nuffield Orthopaedic Centre, Oxford University Hospitals NHS Foundation Trust, Windmill Road, Oxford, OX3 7LD, UK.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Stallard', 'Affiliation': 'Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Leal', 'Affiliation': 'Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'C M', 'Initials': 'CM', 'LastName': 'Lowe', 'Affiliation': 'Physiotherapy Research Unit, Physiotherapy Department, Nuffield Orthopaedic Centre, Oxford University Hospitals NHS Foundation Trust, Windmill Road, Oxford, OX3 7LD, UK.'}, {'ForeName': 'M K', 'Initials': 'MK', 'LastName': 'Javaid', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS), Botnar Research Centre, University of Oxford, Oxford, OX3 7LD, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Noufaily', 'Affiliation': 'Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Hughes', 'Affiliation': 'Physiotherapy Research Unit, Physiotherapy Department, Nuffield Orthopaedic Centre, Oxford University Hospitals NHS Foundation Trust, Windmill Road, Oxford, OX3 7LD, UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Smith', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS), Botnar Research Centre, University of Oxford, Oxford, OX3 7LD, UK.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Gandhi', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS), Botnar Research Centre, University of Oxford, Oxford, OX3 7LD, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Cooper', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS), Botnar Research Centre, University of Oxford, Oxford, OX3 7LD, UK.'}, {'ForeName': 'S E', 'Initials': 'SE', 'LastName': 'Lamb', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS), Botnar Research Centre, University of Oxford, Oxford, OX3 7LD, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA,['10.1007/s00198-019-05133-0']
599,31672711,Pragmatic cluster randomised cohort cross-over trial to determine the effectiveness of bridging from emergency to regular contraception: the Bridge-It study protocol.,"INTRODUCTION


Oral emergency contraception (EC) can prevent unintended pregnancy but it is important to start a regular method of contraception. Women in the UK usually access EC from a pharmacy but then need a subsequent appointment with a general practitioner or a sexual and reproductive health (SRH) service to access regular contraception. Unintended pregnancies can occur during this time.
METHODS AND ANALYSIS


Bridge-It is a pragmatic cluster randomised cohort cross-over trial designed to determine whether pharmacist provision of a bridging supply of a progestogen-only pill (POP) plus rapid access to a local SRH clinic, results in increased uptake of effective contraception and prevents more unintended pregnancies than provision of EC alone. Bridge-It involves 31 pharmacies in three UK regions (London, Lothian and Tayside) aiming to recruit 626-737 women. Pharmacies will give EC (levonorgestrel) according to normal practice and recruit women to both intervention and the control phases of the study. In the intervention phase, pharmacists will provide the POP (desogestrel) and offer rapid access to an SRH clinic. In the control phase, pharmacists will advise women to attend a contraceptive provider for contraception (standard care).Women will be asked 4 months later about contraceptive use. Data linkage to abortion registries will provide abortion rates over 12 months. The sample size is calculated on the primary outcome of effective contraception use at 4 months (yes/no) with 90% power and a 5% level of significance. Abortion rates will be an exploratory secondary analysis. Process evaluation includes interviews with pharmacists, SRH clinicians and women. Cost-effectiveness analysis will use a healthcare system perspective and be expressed as incremental cost-effectiveness ratio.
ETHICS AND DISSEMINATION


Ethical approval was received from South East Scotland REC June 2017. Results will be published in peer-reviewed journals and conference presentations.
TRIAL REGISTRATION NUMBER


ISRCTN70616901.",2019,"It involves 31 pharmacies in three UK regions (London, Lothian and Tayside) aiming to recruit 626-737 women.","['interviews with pharmacists, SRH clinicians and women', '31 pharmacies in three UK regions (London, Lothian and Tayside) aiming to recruit 626-737 women']","['POP (desogestrel', 'bridging from emergency to regular contraception', 'Bridge', 'progestogen-only pill (POP) plus rapid access', 'Oral emergency contraception (EC', 'EC (levonorgestrel']",['Abortion rates'],"[{'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0031322', 'cui_str': 'Pharmacies'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C0454912', 'cui_str': 'Lothian (geographic location)'}, {'cui': 'C0454914', 'cui_str': 'Tayside (geographic location)'}]","[{'cui': 'C0439820', 'cui_str': 'Popping sensation quality'}, {'cui': 'C0057558', 'cui_str': 'Desogestrel'}, {'cui': 'C0456378', 'cui_str': 'Type of bridge (attribute)'}, {'cui': 'C0175673', 'cui_str': 'Emergency (qualifier value)'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0700589', 'cui_str': 'Fertility Control'}, {'cui': 'C0420857', 'cui_str': 'Progestogen only oral contraceptive (finding)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0558252', 'cui_str': 'Emergency Contraception'}, {'cui': 'C0023566', 'cui_str': 'Levonorgestrel'}]","[{'cui': 'C0000794', 'cui_str': 'Abortion Rate'}]",737.0,0.223234,"It involves 31 pharmacies in three UK regions (London, Lothian and Tayside) aiming to recruit 626-737 women.","[{'ForeName': 'Sharon Tracey', 'Initials': 'ST', 'LastName': 'Cameron', 'Affiliation': 'Obstetrics and Gynaecology, University of Edinburgh, Edinburgh, UK sharon.cameron@ed.ac.uk.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Baraitser', 'Affiliation': ""Department of Sexual Health, King's College Hospital NHS Foundation Trust, London, UK.""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Glasier', 'Affiliation': 'Obstetrics and Gynaecology, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'McDaid', 'Affiliation': 'MRC/CSO Social and Public Health Sciences Unit, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Norrie', 'Affiliation': 'Edinburgh Clinical Trials Unit, Usher Institute, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Radley', 'Affiliation': 'Directorate of Public Health, NHS Tayside, Dundee, UK.'}, {'ForeName': 'Judith M', 'Initials': 'JM', 'LastName': 'Stephenson', 'Affiliation': ""UCL Elizabeth Garrett Anderson Institute for Women's Health, University College London, London, UK.""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Trussell', 'Affiliation': 'Office of Population Research, Princeton University, Princeton, New Jersey, USA.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Battison', 'Affiliation': 'Edinburgh Clinical Trials Unit, Usher Institute, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Cameron', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Cowle', 'Affiliation': 'Boots UK Ltd, Edinburgh, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Forrest', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Gilson', 'Affiliation': 'Institute for Global Health, University College London, London, UK.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Goulao', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Johnstone', 'Affiliation': 'Obstetrics and Gynaecology, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'McDonald', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Morelli', 'Affiliation': ""Department of Sexual Health, King's College Hospital NHS Foundation Trust, London, UK.""}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Patterson', 'Affiliation': 'MRC/CSO Social and Public Health Sciences Unit, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Deirdre', 'Initials': 'D', 'LastName': 'Sally', 'Affiliation': 'Institute for Global Health, University College London, London, UK.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Stewart', 'Affiliation': 'Institute for Global Health, University College London, London, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-029978']
600,31005385,"Levetiracetam versus phenytoin for second-line treatment of paediatric convulsive status epilepticus (EcLiPSE): a multicentre, open-label, randomised trial.","BACKGROUND


Phenytoin is the recommended second-line intravenous anticonvulsant for treatment of paediatric convulsive status epilepticus in the UK; however, some evidence suggests that levetiracetam could be an effective and safer alternative. This trial compared the efficacy and safety of phenytoin and levetiracetam for second-line management of paediatric convulsive status epilepticus.
METHODS


This open-label, randomised clinical trial was undertaken at 30 UK emergency departments at secondary and tertiary care centres. Participants aged 6 months to under 18 years, with convulsive status epilepticus requiring second-line treatment, were randomly assigned (1:1) using a computer-generated randomisation schedule to receive levetiracetam (40 mg/kg over 5 min) or phenytoin (20 mg/kg over at least 20 min), stratified by centre. The primary outcome was time from randomisation to cessation of convulsive status epilepticus, analysed in the modified intention-to-treat population (excluding those who did not require second-line treatment after randomisation and those who did not provide consent). This trial is registered with ISRCTN, number ISRCTN22567894.
FINDINGS


Between July 17, 2015, and April 7, 2018, 1432 patients were assessed for eligibility. After exclusion of ineligible patients, 404 patients were randomly assigned. After exclusion of those who did not require second-line treatment and those who did not consent, 286 randomised participants were treated and had available data: 152 allocated to levetiracetam, and 134 to phenytoin. Convulsive status epilepticus was terminated in 106 (70%) children in the levetiracetam group and in 86 (64%) in the phenytoin group. Median time from randomisation to cessation of convulsive status epilepticus was 35 min (IQR 20 to not assessable) in the levetiracetam group and 45 min (24 to not assessable) in the phenytoin group (hazard ratio 1·20, 95% CI 0·91-1·60; p=0·20). One participant who received levetiracetam followed by phenytoin died as a result of catastrophic cerebral oedema unrelated to either treatment. One participant who received phenytoin had serious adverse reactions related to study treatment (hypotension considered to be immediately life-threatening [a serious adverse reaction] and increased focal seizures and decreased consciousness considered to be medically significant [a suspected unexpected serious adverse reaction]).
INTERPRETATION


Although levetiracetam was not significantly superior to phenytoin, the results, together with previously reported safety profiles and comparative ease of administration of levetiracetam, suggest it could be an appropriate alternative to phenytoin as the first-choice, second-line anticonvulsant in the treatment of paediatric convulsive status epilepticus.
FUNDING


National Institute for Health Research Health Technology Assessment programme.",2019,"Median time from randomisation to cessation of convulsive status epilepticus was 35 min (IQR 20 to not assessable) in the levetiracetam group and 45 min (24 to not assessable) in the phenytoin group (hazard ratio 1·20, 95% CI 0·91-1·60; p=0·20).","['404 patients', '30 UK emergency departments at secondary and tertiary care centres', 'Between July 17, 2015, and April 7, 2018, 1432 patients were assessed for eligibility', 'paediatric convulsive status epilepticus (EcLiPSE', 'Participants aged 6 months to under 18 years, with convulsive status epilepticus requiring second-line treatment']","['phenytoin and levetiracetam', 'levetiracetam', 'phenytoin', 'Levetiracetam versus phenytoin']","['catastrophic cerebral oedema', 'Convulsive status epilepticus', 'focal seizures', 'time from randomisation to cessation of convulsive status epilepticus, analysed in the modified intention-to-treat population', 'serious adverse reaction', 'Median time from randomisation to cessation of convulsive status epilepticus', 'serious adverse reactions', 'efficacy and safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C4708917', 'cui_str': 'One thousand four hundred and thirty-two'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0311335', 'cui_str': 'Grand Mal Status Epilepticus'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1710038', 'cui_str': 'Second line treatment'}]","[{'cui': 'C0031507', 'cui_str': 'Phenytoin'}, {'cui': 'C0377265', 'cui_str': 'Levetiracetam'}]","[{'cui': 'C0006114', 'cui_str': 'Cerebral Edema'}, {'cui': 'C0311335', 'cui_str': 'Grand Mal Status Epilepticus'}, {'cui': 'C0751495', 'cui_str': 'Seizures, Focal'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",1432.0,0.226667,"Median time from randomisation to cessation of convulsive status epilepticus was 35 min (IQR 20 to not assessable) in the levetiracetam group and 45 min (24 to not assessable) in the phenytoin group (hazard ratio 1·20, 95% CI 0·91-1·60; p=0·20).","[{'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'Lyttle', 'Affiliation': 'Emergency Department, Bristol Royal Hospital for Children, Bristol, UK; Faculty of Health and Applied Sciences, University of the West of England, Bristol, UK.'}, {'ForeName': 'Naomi E A', 'Initials': 'NEA', 'LastName': 'Rainford', 'Affiliation': ""Clinical Trials Research Centre, University of Liverpool, Liverpool, UK; Institute of Child Health, Alder Hey Children's NHS Foundation Trust, Liverpool, UK.""}, {'ForeName': 'Carrol', 'Initials': 'C', 'LastName': 'Gamble', 'Affiliation': ""Department of Biostatistics, University of Liverpool, Liverpool, UK; Clinical Trials Research Centre, University of Liverpool, Liverpool, UK; Institute of Child Health, Alder Hey Children's NHS Foundation Trust, Liverpool, UK.""}, {'ForeName': 'Shrouk', 'Initials': 'S', 'LastName': 'Messahel', 'Affiliation': ""Emergency Department, Alder Hey Children's NHS Foundation Trust, Liverpool, UK.""}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Humphreys', 'Affiliation': ""Clinical Trials Research Centre, University of Liverpool, Liverpool, UK; Institute of Child Health, Alder Hey Children's NHS Foundation Trust, Liverpool, UK.""}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Hickey', 'Affiliation': ""Clinical Trials Research Centre, University of Liverpool, Liverpool, UK; Institute of Child Health, Alder Hey Children's NHS Foundation Trust, Liverpool, UK.""}, {'ForeName': 'Kerry', 'Initials': 'K', 'LastName': 'Woolfall', 'Affiliation': 'Institute of Population Health Sciences, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Roper', 'Affiliation': 'Institute of Population Health Sciences, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Noblet', 'Affiliation': ""Emergency Department, Alder Hey Children's NHS Foundation Trust, Liverpool, UK.""}, {'ForeName': 'Elizabeth D', 'Initials': 'ED', 'LastName': 'Lee', 'Affiliation': ""Emergency Department, Alder Hey Children's NHS Foundation Trust, Liverpool, UK.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Potter', 'Affiliation': 'Emergency Department, Bristol Royal Hospital for Children, Bristol, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Tate', 'Affiliation': ""Clinical Trials Research Centre, University of Liverpool, Liverpool, UK; Institute of Child Health, Alder Hey Children's NHS Foundation Trust, Liverpool, UK.""}, {'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Iyer', 'Affiliation': ""Department of Neurology, Alder Hey Children's NHS Foundation Trust, Liverpool, UK.""}, {'ForeName': 'Vicki', 'Initials': 'V', 'LastName': 'Evans', 'Affiliation': 'Wrexham, Clwyd, UK.'}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Appleton', 'Affiliation': ""Department of Neurology, Alder Hey Children's NHS Foundation Trust, Liverpool, UK. Electronic address: richardappleton55@hotmail.co.uk.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(19)30724-X']
601,31662381,Whole family-based physical activity promotion intervention: the Families Reporting Every Step to Health pilot randomised controlled trial protocol.,"INTRODUCTION


Family-based physical activity (PA) interventions present a promising avenue to promote children's activity; however, high-quality experimental research is lacking. This paper describes the protocol for the FRESH (Families Reporting Every Step to Health) pilot trial, a child-led family-based PA intervention delivered online.
METHODS AND ANALYSIS


FRESH is a three-armed, parallel-group, randomised controlled pilot trial using a 1:1:1 allocation ratio with follow-up assessments at 8 and 52 weeks postbaseline. Families will be eligible if a minimum of one child in school Years 3-6 (aged 7-11 years) and at least one adult responsible for that child are willing to participate. Family members can take part in the intervention irrespective of their participation in the accompanying evaluation and vice versa.Following baseline assessment, families will be randomly allocated to one of three arms: (1) FRESH; (2) pedometer-only or (3) no-intervention control. All family members in the pedometer-only and FRESH arms receive pedometers and generic PA promotion information. FRESH families additionally receive access to the intervention website; allowing participants to select step challenges to 'travel' to target cities around the world, log steps and track progress as they virtually globetrot. Control families will receive no treatment. All family members will be eligible to participate in the evaluation with two follow-ups (8 and 52 weeks). Physical (eg, fitness and blood pressure), psychosocial (eg, social support) and behavioural (eg, objectively measured family PA) measures will be collected at each time point. At 8-week follow-up, a mixed methods process evaluation will be conducted (questionnaires and family focus groups) assessing acceptability of the intervention and evaluation. FRESH families' website engagement will also be explored.
ETHICS AND DISSEMINATION


This study received ethical approval from the Ethics Committee for the School of the Humanities and Social Sciences at the University of Cambridge. Findings will be disseminated via peer-reviewed publications, conferences and to participating families.
TRIAL REGISTRATION NUMBER


ISRCTN12789422.",2019,"FRESH families additionally receive access to the intervention website; allowing participants to select step challenges to 'travel' to target cities around the world, log steps and track progress as they virtually globetrot.",['Families will be eligible if a minimum of one child in school Years 3-6 (aged 7-11 years) and at least one adult responsible for that child are willing to participate'],"['Whole family-based physical activity promotion intervention', 'Family-based physical activity (PA) interventions', 'child-led family-based PA intervention delivered online', 'FRESH; (2) pedometer-only or (3) no-intervention control']","['Physical (eg, fitness and blood pressure), psychosocial (eg, social support) and behavioural (eg, objectively measured family PA) measures']","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0600109', 'cui_str': 'Willing (finding)'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0443224', 'cui_str': 'Fresh (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0037438'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0015576', 'cui_str': 'Family'}]",,0.0646976,"FRESH families additionally receive access to the intervention website; allowing participants to select step challenges to 'travel' to target cities around the world, log steps and track progress as they virtually globetrot.","[{'ForeName': 'Justin M', 'Initials': 'JM', 'LastName': 'Guagliano', 'Affiliation': 'MRC Epidemiology Unit and UKCRC Centre for Diet and Activity Research, University of Cambridge, Cambridge, UK justin.guagliano@mrc-epid.cam.ac.uk.'}, {'ForeName': 'Helen Elizabeth', 'Initials': 'HE', 'LastName': 'Brown', 'Affiliation': 'MRC Epidemiology Unit and UKCRC Centre for Diet and Activity Research, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Coombes', 'Affiliation': 'Norwich Medical School and UKCRC Centre for Diet and Activity Research, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Elizabeth S', 'Initials': 'ES', 'LastName': 'Haines', 'Affiliation': 'MRC Epidemiology Unit and UKCRC Centre for Diet and Activity Research, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Hughes', 'Affiliation': 'Centre for Family Research, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Andrew P', 'Initials': 'AP', 'LastName': 'Jones', 'Affiliation': 'Norwich Medical School and UKCRC Centre for Diet and Activity Research, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Katie L', 'Initials': 'KL', 'LastName': 'Morton', 'Affiliation': 'MRC Epidemiology Unit and UKCRC Centre for Diet and Activity Research, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'van Sluijs', 'Affiliation': 'MRC Epidemiology Unit and UKCRC Centre for Diet and Activity Research, University of Cambridge, Cambridge, UK.'}]",BMJ open,['10.1136/bmjopen-2019-030902']
602,31678307,A Prospective Randomized Comparative Study of Three Guided Bronchoscopic Approaches for Investigating Pulmonary Nodules: The PRECISION-1 Study.,"BACKGROUND


The capability of bronchoscopy in the diagnosis of peripheral pulmonary nodules (PPNs) remains limited. Despite decades of effort, evidence suggests that the diagnostic accuracy for electromagnetic navigational bronchoscopy (EMN) and radial endobronchial ultrasound (EBUS) approach only 50%. New developments in robotic bronchoscopy (RB) may offer improvements in the assessment of PPNs.
METHODS


A prospective single-blinded randomized controlled comparative study to assess success in localization and puncture of PPNs, using an ultrathin bronchoscope with radial EBUS (UTB-rEBUS) vs EMN vs RB in a human cadaver model of PPNs < 2 cm, was performed. The primary end point was the ability to successfully localize and puncture the target nodule, verified by cone-beam CT comparing RB and EMN. Secondary end points included needle to target position ""miss"" distance, and UTB-rEBUS comparisons.
RESULTS


Sixty procedures were performed to target 20 PPNs over the study period. Implanted PPNs were distributed across all lobes, with 80% located within the lung periphery. The target PPN mean diameter was 16.5 ± 1.5 mm, with 50% noted to have a CT bronchus sign. The rate of successful PPN localization and puncture was superior when using RB, compared with EMN (80% vs 45%; P = .02). Among unsuccessful needle passes, the median needle to target ""miss"" distance was significantly different when comparing UTB-rEBUS, EMN, and RB (P = .0014).
CONCLUSIONS


In a cadaver model, use of RB significantly increased the ability to localize and successfully puncture small PPNs when compared with existing technologies. This study demonstrates the potential of RB to precisely reach, localize, and puncture small nodules in the periphery of the lung.",2020,"In a cadaver model, utilization of RB significantly increased the ability to localize and successfully puncture small PPN when compared with existing technologies.",['and Methods'],"['robotic bronchoscopy (RB', 'Guided Bronchoscopic Approaches', 'PPN utilizing an ultrathin bronchoscope with radial EBUS (UTB-rEBUS) vs EMN vs RB']","['needle to target position, ""miss"" distance and UTB-rEBUS comparisons', 'median needle to target ""miss"" distance', 'rate of successful PPN localization and puncture', 'ability to successfully localize and puncture the target nodule verified using cone-beam CT comparing RB and EMN']","[{'cui': 'C0025663', 'cui_str': 'Methods'}]","[{'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0006290', 'cui_str': 'Bronchoscopy'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0179432', 'cui_str': 'Bronchoscopes'}, {'cui': 'C0442038', 'cui_str': 'Radial (qualifier value)'}]","[{'cui': 'C0398296', 'cui_str': 'Cannulation of vascular fistula, graft or prosthetic device (procedure)'}, {'cui': 'C1561964', 'cui_str': 'Patient Positioning'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0475264', 'cui_str': 'Localization - action (qualifier value)'}, {'cui': 'C0033119', 'cui_str': 'Puncture wound - injury (disorder)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0392752', 'cui_str': 'Localized (qualifier value)'}, {'cui': 'C0028259', 'cui_str': 'Nodule (morphologic abnormality)'}, {'cui': 'C1956110', 'cui_str': 'Cone-Beam Computerized Tomography'}]",,0.0907955,"In a cadaver model, utilization of RB significantly increased the ability to localize and successfully puncture small PPN when compared with existing technologies.","[{'ForeName': 'Lonny', 'Initials': 'L', 'LastName': 'Yarmus', 'Affiliation': 'Division of Pulmonary and Critical Care, Johns Hopkins University School of Medicine, Baltimore, MD. Electronic address: lyarmus@jhmi.edu.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Akulian', 'Affiliation': 'Division of Pulmonary and Critical Care, University of North Carolina School of Medicine, Chapel Hill, NC.'}, {'ForeName': 'Momen', 'Initials': 'M', 'LastName': 'Wahidi', 'Affiliation': 'Division of Pulmonary and Critical Care, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Chen', 'Affiliation': 'Division of Pulmonary and Critical Care, Washington University of St. Louis School of Medicine, St. Louis, MO.'}, {'ForeName': 'Jennifer P', 'Initials': 'JP', 'LastName': 'Steltz', 'Affiliation': 'Division of Pulmonary and Critical Care, University of Pennsylvania School of Medicine, Philadelphia, PA.'}, {'ForeName': 'Sam L', 'Initials': 'SL', 'LastName': 'Solomon', 'Affiliation': 'Division of Pulmonary and Critical Care, University of Pennsylvania School of Medicine, Philadelphia, PA.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Yu', 'Affiliation': 'Division of Pulmonary and Critical Care, Stanford University School of Medicine, Stanford, CA.'}, {'ForeName': 'Fabien', 'Initials': 'F', 'LastName': 'Maldonado', 'Affiliation': 'Division of Pulmonary and Critical Care, Vanderbilt University School of Medicine, Nashville, TN.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Cardenas-Garcia', 'Affiliation': 'Division of Pulmonary and Critical Care, University of Michigan School of Medicine, Ann Arbor, MI.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Molena', 'Affiliation': 'Division of Thoracic Surgery, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Division of Pulmonary and Critical Care, Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Anil', 'Initials': 'A', 'LastName': 'Vachani', 'Affiliation': 'Division of Pulmonary and Critical Care, University of Pennsylvania School of Medicine, Philadelphia, PA; Division of Pulmonary and Critical Care, University of Pennsylvania School of Medicine, and the Corporal Michael J. Crescenz VA Medical Center Philadelphia, PA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Chest,['10.1016/j.chest.2019.10.016']
603,31010449,Does trauma-focused exposure therapy exacerbate symptoms among patients with comorbid PTSD and substance use disorders?,"BACKGROUND


Although exposure-based therapy is a well-established, effective treatment for post-traumatic stress disorder (PTSD), some practitioners report reluctance to implement it due to concerns that it may exacerbate symptoms of PTSD and commonly comorbid disorders, such as substance use disorders (SUD).
AIM


This study compared the exacerbation of psychological symptoms among participants with comorbid PTSD and SUD who received either SUD treatment alone or SUD treatment integrated with exposure therapy for PTSD.
METHOD


Participants (N = 71) were treatment-seeking, military Veterans with comorbid PTSD and SUD who were randomized to 12 individual sessions of either (1) an integrated, exposure-based treatment (Concurrent Treatment of PTSD and Substance Use Disorders using Prolonged Exposure; COPE); or (2) a non-exposure-based, SUD-only treatment (Relapse Prevention; RP). We examined between-group differences in the frequency of statistically reliable exacerbations of PTSD, SUD and depression symptoms experienced during treatment.
RESULTS


At each of the 12 sessions, symptom exacerbation was minimal and generally equally likely in either treatment group. However, an analysis of treatment completers suggests that RP participants experienced slightly more exacerbations of PTSD symptoms during the course of treatment.
CONCLUSIONS


This study is the first to investigate symptom exacerbation throughout trauma-focused exposure therapy for individuals with comorbid PTSD and SUD. Results add to a growing literature which suggests that trauma-focused, exposure-based therapy does not increase the risk of symptom exacerbation relative to non-exposure-based therapy.",2020,"We examined between-group differences in the frequency of statistically reliable exacerbations of PTSD, SUD and depression symptoms experienced during treatment.
","['Participants (N = 71) were treatment-seeking, military Veterans with comorbid PTSD and SUD who were randomized to 12', 'participants with comorbid PTSD and SUD who received either', 'individuals with comorbid PTSD and SUD', 'patients with comorbid PTSD and substance use disorders']","['SUD treatment alone or SUD treatment integrated with exposure therapy for PTSD', 'individual sessions of either (1) an integrated, exposure-based treatment (Concurrent Treatment of PTSD and Substance Use Disorders using Prolonged Exposure; COPE); or (2) a non-exposure-based, SUD-only treatment (Relapse Prevention; RP']","['symptom exacerbation', 'exacerbations of PTSD symptoms', 'frequency of statistically reliable exacerbations of PTSD, SUD and depression symptoms']","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0026126', 'cui_str': 'Armed Forces Personnel'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0038586', 'cui_str': 'Substance Use Disorders'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0038586', 'cui_str': 'Substance Use Disorders'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0679867', 'cui_str': 'Relapse Prevention'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]",71.0,0.0170547,"We examined between-group differences in the frequency of statistically reliable exacerbations of PTSD, SUD and depression symptoms experienced during treatment.
","[{'ForeName': 'Cynthia L', 'Initials': 'CL', 'LastName': 'Lancaster', 'Affiliation': 'Department of Psychology, University of Nevada Reno, Reno, NV, USA.'}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'Gros', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Mullarkey', 'Affiliation': 'Department of Psychology, University of Texas, Austin, TX, USA.'}, {'ForeName': 'Christal L', 'Initials': 'CL', 'LastName': 'Badour', 'Affiliation': 'Department of Psychology, University of Kentucky, Lexington, KY, USA.'}, {'ForeName': 'Therese K', 'Initials': 'TK', 'LastName': 'Killeen', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Kathleen T', 'Initials': 'KT', 'LastName': 'Brady', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Sudie E', 'Initials': 'SE', 'LastName': 'Back', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA.'}]",Behavioural and cognitive psychotherapy,['10.1017/S1352465819000304']
604,31818839,Testing the effectiveness of a weight loss intervention to enhance self-regulation in adults who are obese: protocol for a randomised controlled trial.,"INTRODUCTION


Previous trials finding an effect of self-monitoring on weight loss have considered the effect to be mediated by self-regulatory processes. However, a qualitative think-aloud study asking people to record thoughts and feelings during weighing showed that self-regulation occurs only rarely without further instruction. The aim of this trial is to test a novel intervention guiding people through the self-regulatory processes to see whether it facilitates weight loss.
METHODS AND ANALYSES


A parallel group, randomised controlled trial will be conducted to test the concept that a self-regulation intervention for weight loss increases weight loss compared with daily self-weighing without further support. One hundred participants with a body mass index ≥30 kg/m 2  will be randomised to either the control or intervention group. The control group will be asked to weigh themselves daily for 8 weeks, the intervention group will be encouraged to follow the self-regulation intervention. They will be prompted to weigh daily, track their weight using an app, plan daily actions for weight loss and reflect on their action plans on a weekly basis. This self-regulation cycle will allow them to experiment with different weight loss strategies and identify effective and sustainable actions. Primary and process outcomes will be measured at baseline and 8 weeks' follow-up. Linear regression analysis of the primary outcome, weight change, will assess the early effectiveness of the intervention. The process outcomes liking, perceived effectiveness, as well as usage and barriers with regard to the self-regulation intervention, will be assessed through qualitative analysis of follow-up interviews and quantitative analysis of adherence rates and responses to a final questionnaire.
ETHICS AND DISSEMINATION


This trial was reviewed and approved by the NHS National Research Ethics Committee and the Health Research Authority (reference number: 18/SC/0482). The findings of the trial will be published in peer reviewed journals and presented at conferences.
TRIAL REGISTRATION NUMBER


ISRCTN14148239, prerecruitment.
PROTOCOL VERSION


Version 1.1, 7 December 2018.",2019,One hundred participants with a body mass index ≥30 kg/m 2  will be randomised to either the control or intervention group.,"['One hundred participants with a body mass index ≥30 kg/m 2', 'adults who are obese', 'VERSION\n\n\nVersion 1.1, 7 December 2018']","['self-regulation intervention', 'weight loss intervention']","['weight loss', 'outcomes liking, perceived effectiveness, as well as usage and barriers with regard to the self-regulation intervention', 'qualitative analysis of follow-up interviews and quantitative analysis of adherence rates and responses to a final questionnaire', 'weight change']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C4517491', 'cui_str': 'One point one'}]","[{'cui': 'C0684274', 'cui_str': 'Self Regulation'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0457083', 'cui_str': 'Usage (attribute)'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0684274', 'cui_str': 'Self Regulation'}, {'cui': 'C0205556', 'cui_str': 'Qualitative (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}]",100.0,0.142244,One hundred participants with a body mass index ≥30 kg/m 2  will be randomised to either the control or intervention group.,"[{'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Frie', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, Oxfordshire, UK kerstin.frie@phc.ox.ac.uk.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Hartmann-Boyce', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, Oxfordshire, UK.'}, {'ForeName': 'Susan A', 'Initials': 'SA', 'LastName': 'Jebb', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, Oxfordshire, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Aveyard', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, Oxfordshire, UK.'}]",BMJ open,['10.1136/bmjopen-2019-031572']
605,32146720,Adjunctive effects of laser therapy on somatosensory function and vasomotor regulation of periodontal tissues in patients with periodontitis: A randomized controlled clinical trial.,"BACKGROUND


The purpose of this prospective study was to compare the changes in periodontal somatosensory function and microcirculation in patients with periodontitis following initial treatment with scaling and root planing (SRP) with or without adjuvant laser therapy.
METHODS


Twenty-four patients suffering from periodontitis were recruited and randomly allocated into a split-mouth design to either SRP combined laser therapy side (test side) or SRP only side (control side). All treatments were performed by the same investigator at a single visit. Laser Doppler Flowmetry (LDF) and Quantitative Sensory Testing (QST) were performed at baseline (W0), 1 week (1W), 2 weeks (2W), and 4 weeks (4W) after treatment on both sides of the attached gingiva of the maxillary lateral incisor. Clinical examination including probing depth (PD) and bleeding on probing (BOP) was performed at W0, 2W, and 4W on both sides. Data were analyzed with two-way analysis of variance.
RESULTS


PD and BOP significantly improved after treatment (P <0.001). LDF values were significantly decreased on both sides at all follow-up time points (P <0.001), temperature was increased only on the test side (P = 0.017) whereas there was no significant change on the control side (P = 0.792). Significantly less sensitivity was observed for all QST parameters (P <0.030) except for warmth detection after treatment.
CONCLUSION


Adjunctive use of laser therapy did not provide any significant clinical advantage or additional effects on the recovery of periodontal somatosensory function or gingival microcirculation in the present study.",2020,"The LDF values were significantly decreased on both sides at all follow-up time points (P <0.001), temperature was increased only on the test side (P = 0.017) whereas there was no significant change on the control side (P = 0.792).","['patients with periodontitis', 'patients with periodontitis following initial treatment with scaling and root planing (SRP) with or without adjuvant laser therapy', 'Twenty-four patients suffering from periodontitis']","['laser therapy', 'SRP combined laser therapy side (test side) or SRP only side (control side']","['somatosensory function and vasomotor regulation of periodontal tissues', 'periodontal somatosensory function or gingival microcirculation', 'LDF values', 'Laser Doppler Flowmetry (LDF) and Quantitative Sensory Testing (QST', 'PPD and BOP', 'sensitivity', 'pocket probing depth (PPD) and bleeding on probing (BOP']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0085287', 'cui_str': 'Root Planings'}, {'cui': 'C1955835', 'cui_str': 'Laser Therapy'}, {'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}]","[{'cui': 'C1955835', 'cui_str': 'Laser Therapy'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0031104', 'cui_str': 'Tooth Supporting Structures'}, {'cui': 'C4521854', 'cui_str': 'Gingival (intended site)'}, {'cui': 'C0025962', 'cui_str': 'Microcirculation'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0162520', 'cui_str': 'Laser-Doppler Flowmetry'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0200116', 'cui_str': 'Sensory testing'}, {'cui': 'C0034131', 'cui_str': 'Purified Protein Derivative of Tuberculin'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C3179165', 'cui_str': 'Probe (methazole)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}]",24.0,0.0325481,"The LDF values were significantly decreased on both sides at all follow-up time points (P <0.001), temperature was increased only on the test side (P = 0.017) whereas there was no significant change on the control side (P = 0.792).","[{'ForeName': 'Huiqing', 'Initials': 'H', 'LastName': 'Gou', 'Affiliation': 'Jiangsu Key Laboratory of Oral Disease, Affiliated Hospital of Stomatology, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Ruyi', 'Initials': 'R', 'LastName': 'Fan', 'Affiliation': 'Jiangsu Key Laboratory of Oral Disease, Affiliated Hospital of Stomatology, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Jiangsu Key Laboratory of Oral Disease, Affiliated Hospital of Stomatology, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Jiangsu Key Laboratory of Oral Disease, Affiliated Hospital of Stomatology, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Xiaoqian', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Jiangsu Key Laboratory of Oral Disease, Affiliated Hospital of Stomatology, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Jiangsu Key Laboratory of Oral Disease, Affiliated Hospital of Stomatology, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Svensson', 'Affiliation': 'Section of Orofacial Pain and Jaw Function, Department of Dentistry and Oral Health, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Kelun', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Section of Orofacial Pain and Jaw Function, Department of Dentistry and Oral Health, Aarhus University, Aarhus, Denmark.'}]",Journal of periodontology,['10.1002/JPER.19-0562']
606,31981597,Effect of Aromatherapy Massage on Quality of Sleep in the Palliative Care Ward: A Randomized Controlled Trial.,"CONTEXT


There is little evidence of the effectiveness of aromatherapy massage in palliative care despite its popularity.
OBJECTIVES


This study aimed to investigate the effects of a 30-minute single session of aromatherapy massage at night time on quality of sleep and fatigue in palliative care.
METHODS


A randomized controlled trial from January 2018 to March 2019. After being stratified by sex, participants were randomly assigned to an aromatherapy massage group and a control group. The effects of aromatherapy massage were evaluated on the massage day and the next day using the Richards-Campbell Sleep Questionnaire and the Brief Fatigue Inventory.
RESULTS


Of the 74 participants, data of 27 participants in the treatment group and 30 participants in the control group were analyzed. Analysis of covariance indicated that quality of sleep and fatigue did not improve owing to the aromatherapy massage, although usual fatigue in preceding 24 hours and enjoyment of life subscales of the Brief Fatigue Inventory showed signs of contribution (P = 0.07 and 0.09, respectively). Post hoc analyses indicated that higher age and performance status were factors with moderate correlation with better sleep (P = 0.03; r = 0.45 and P = 0.03; r = 0.40, respectively), and that older patients tended to experience greater improvement in fatigue (P = 0.02; r = -0.47).
CONCLUSION


A single aromatherapy massage session is no more effective than not having a massage in improving sleep quality in palliative care settings. However, older patients and those in poor health conditions may benefit from aromatherapy massage.",2020,A single aromatherapy massage session is no more effective than not having a massage in improving sleep quality in palliative care settings.,"['74 participants, data of 27 participants in the treatment group and 30 in the control group were analyzed', 'January 2018 to March 2019']","['aromatherapy massage session', 'aromatherapy massage']","['quality of sleep', 'Campbell Sleep Questionnaire (RCSQ) and the Brief Fatigue Inventory (BFI', 'sleep quality', 'quality of sleep and fatigue', 'fatigue', 'usual fatigue']","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C2585844', 'cui_str': 'Aromatherapy massage (regime/therapy)'}]","[{'cui': 'C0424563', 'cui_str': 'Quality of sleep (observable entity)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]",,0.0546885,A single aromatherapy massage session is no more effective than not having a massage in improving sleep quality in palliative care settings.,"[{'ForeName': 'Noriyuki', 'Initials': 'N', 'LastName': 'Kawabata', 'Affiliation': 'Department of Palliative Care, Osaka Rosai Hospital, Sakai City, Osaka, Japan. Electronic address: off.kawabata@gmail.com.'}, {'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Hata', 'Affiliation': 'Department of Palliative Care, National Hospital Organization, Kyoto Medical Center, Fukakusa Mukaihata-cho Fushimi-ku, Kyoto City, Kyoto, Japan.'}, {'ForeName': 'Tomokazu', 'Initials': 'T', 'LastName': 'Aoki', 'Affiliation': 'Department of Palliative Care, National Hospital Organization, Kyoto Medical Center, Fukakusa Mukaihata-cho Fushimi-ku, Kyoto City, Kyoto, Japan.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2020.01.003']
607,31852579,3-month versus 6-month adjuvant chemotherapy for patients with high-risk stage II and III colorectal cancer: 3-year follow-up of the SCOT non-inferiority RCT.,"BACKGROUND


Oxaliplatin and fluoropyrimidine chemotherapy administered over 6 months is the standard adjuvant regimen for patients with high-risk stage II or III colorectal cancer. However, the regimen is associated with cumulative toxicity, characterised by chronic and often irreversible neuropathy.
OBJECTIVES


To assess the efficacy of 3-month versus 6-month adjuvant chemotherapy for colorectal cancer and to compare the toxicity, health-related quality of life and cost-effectiveness of the durations.
DESIGN


An international, randomised, open-label, non-inferiority, Phase III, parallel-group trial.
SETTING


A total of 244 oncology clinics from six countries: UK (England, Scotland, Wales and Northern Ireland), Denmark, Spain, Sweden, Australia and New Zealand.
PARTICIPANTS


Adults aged ≥ 18 years who had undergone curative resection for high-risk stage II or III adenocarcinoma of the colon or rectum.
INTERVENTIONS


The adjuvant treatment regimen was either oxaliplatin and 5-fluorouracil or oxaliplatin and capecitabine, randomised to be administered over 3 or 6 months.
MAIN OUTCOME MEASURES


The primary outcome was disease-free survival. Overall survival, adverse events, neuropathy and health-related quality of life were also assessed. The main cost categories were chemotherapy treatment and hospitalisation. Cost-effectiveness was assessed through incremental cost comparisons and quality-adjusted life-year gains between the options and was reported as net monetary benefit using a willingness-to-pay threshold of £30,000 per quality-adjusted life-year per patient.
RESULTS


Recruitment is closed. In total, 6088 patients were randomised (3044 per group) between 27 March 2008 and 29 November 2013, with 6065 included in the intention-to-treat analyses (3-month analysis,  n  = 3035; 6-month analysis,  n  = 3030). Follow-up for the primary analysis is complete. The 3-year disease-free survival rate in the 3-month treatment group was 76.7% (standard error 0.8%) and in the 6-month treatment group was 77.1% (standard error 0.8%), equating to a hazard ratio of 1.006 (95% confidence interval 0.909 to 1.114;  p -value for non-inferiority = 0.012), confirming non-inferiority for 3-month adjuvant chemotherapy. Frequent adverse events (alopecia, anaemia, anorexia, diarrhoea, fatigue, hand-foot syndrome, mucositis, sensory neuropathy, neutropenia, pain, rash, altered taste, thrombocytopenia and watery eye) showed a significant increase in grade with 6-month duration; the greatest difference was for sensory neuropathy (grade ≥ 3 was 4% for 3-month vs.16% for 6-month duration), for which a higher rate of neuropathy was seen for the 6-month treatment group from month 4 to ≥ 5 years ( p  < 0.001). Quality-of-life scores were better in the 3-month treatment group over months 4-6. A cost-effectiveness analysis showed 3-month treatment to cost £4881 less over the 8-year analysis period, with an incremental net monetary benefit of £7246 per patient.
CONCLUSIONS


The study achieved its primary end point, showing that 3-month oxaliplatin-containing adjuvant chemotherapy is non-inferior to 6 months of the same regimen; 3-month treatment showed a better safety profile and cost less. For future work, further follow-up will refine long-term estimates of the duration effect on disease-free survival and overall survival. The health economic analysis will be updated to include long-term extrapolation for subgroups. We expect these analyses to be available in 2019-20. The Short Course Oncology Therapy (SCOT) study translational samples may allow the identification of patients who would benefit from longer treatment based on the molecular characteristics of their disease.
TRIAL REGISTRATION


Current Controlled Trials ISRCTN59757862 and EudraCT 2007-003957-10.
FUNDING


This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in  Health Technology Assessment ; Vol. 23, No. 64. See the NIHR Journals Library website for further project information. This research was supported by the Medical Research Council (transferred to NIHR Evaluation, Trials and Studies Coordinating Centre - Efficacy and Mechanism Evaluation; grant reference G0601705), the Swedish Cancer Society and Cancer Research UK Core Clinical Trials Unit Funding (funding reference C6716/A9894).",2019,"A cost-effectiveness analysis showed 3-month treatment to cost £4881 less over the 8-year analysis period, with an incremental net monetary benefit of £7246 per patient.
","['patients with high-risk stage II and III colorectal cancer', 'Adults aged ≥\u200918 years who had undergone curative resection for high-risk stage II or III adenocarcinoma of the colon or rectum', 'A total of 244 oncology clinics from six countries: UK (England, Scotland, Wales and Northern Ireland), Denmark, Spain, Sweden, Australia and New Zealand', 'patients with high-risk stage II or III colorectal cancer', '6088 patients were randomised (3044 per group) between 27 March 2008 and 29 November 2013, with 6065 included in the intention-to-treat analyses (3-month analysis,  n \u2009=\u20093035; 6-month analysis,  n \u2009=\u20093030']","['oxaliplatin-containing adjuvant chemotherapy', 'Oxaliplatin and fluoropyrimidine chemotherapy', 'oxaliplatin and 5-fluorouracil or oxaliplatin and capecitabine', 'adjuvant chemotherapy']","['3-year disease-free survival rate', 'cumulative toxicity', 'disease-free survival', 'sensory neuropathy', 'Cost-effectiveness', 'toxicity, health-related quality of life and cost-effectiveness', 'Quality-of-life scores', 'disease-free survival and overall survival', 'rate of neuropathy', 'Overall survival, adverse events, neuropathy and health-related quality of life', 'safety profile and cost less', 'incremental cost comparisons and quality-adjusted life-year gains', 'Frequent adverse events (alopecia, anaemia, anorexia, diarrhoea, fatigue, hand-foot syndrome, mucositis, sensory neuropathy, neutropenia, pain, rash, altered taste, thrombocytopenia and watery eye']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1276305', 'cui_str': 'Curative procedure'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}, {'cui': 'C0009368', 'cui_str': 'Colon'}, {'cui': 'C0034896', 'cui_str': 'Rectum'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517660', 'cui_str': 'Two hundred and forty-four'}, {'cui': 'C3839015', 'cui_str': 'Oncology clinic'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0036453', 'cui_str': 'Scotland'}, {'cui': 'C0028415', 'cui_str': 'Northern Ireland'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0151313', 'cui_str': 'Sensory neuropathy (disorder)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy (disorder)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C3853050', 'cui_str': 'Cost Comparison'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C0002170', 'cui_str': 'Hair Loss'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C1971624', 'cui_str': 'Loss of appetite (finding)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0852711', 'cui_str': 'Hand-foot syndrome in sickle cell anemia (disorder)'}, {'cui': 'C0333355', 'cui_str': 'Mucositis'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015230', 'cui_str': 'Skin Rash'}, {'cui': 'C0039336', 'cui_str': 'Gustation'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C3257803', 'cui_str': 'Watery eye (finding)'}]",244.0,0.236886,"A cost-effectiveness analysis showed 3-month treatment to cost £4881 less over the 8-year analysis period, with an incremental net monetary benefit of £7246 per patient.
","[{'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Iveson', 'Affiliation': 'Southampton University Hospital NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Kathleen A', 'Initials': 'KA', 'LastName': 'Boyd', 'Affiliation': 'Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Rachel S', 'Initials': 'RS', 'LastName': 'Kerr', 'Affiliation': 'Department of Oncology, University of Oxford, Oxford, UK.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Robles-Zurita', 'Affiliation': 'Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Mark P', 'Initials': 'MP', 'LastName': 'Saunders', 'Affiliation': 'The Christie Hospital NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Briggs', 'Affiliation': 'Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Cassidy', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Niels Henrik', 'Initials': 'NH', 'LastName': 'Hollander', 'Affiliation': 'Department of Oncology and Palliative Care, Zealand University Hospital, Naestved, Denmark.'}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Tabernero', 'Affiliation': ""Vall d'Hebron University Hospital and Institute of Oncology, Universitat Autònoma de Barcelona, Barcelona, Spain.""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Haydon', 'Affiliation': 'Australasian Gastro-Intestinal Trials Group, Camperdown, NSW, Australia.'}, {'ForeName': 'Bengt', 'Initials': 'B', 'LastName': 'Glimelius', 'Affiliation': 'University of Uppsala, Uppsala, Sweden.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Harkin', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Allan', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'McQueen', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Pearson', 'Affiliation': 'Oncology Clinical Trials Office, Department of Oncology, University of Oxford, Oxford, UK.'}, {'ForeName': 'Ashita', 'Initials': 'A', 'LastName': 'Waterston', 'Affiliation': 'Beatson West of Scotland Cancer Centre, Glasgow, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Medley', 'Affiliation': 'Royal United Hospital, Bath, UK.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Wilson', 'Affiliation': ""Addenbrooke's Hospital, Cambridge, UK.""}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Ellis', 'Affiliation': 'Royal Cornwall Hospitals NHS Trust, Cornwall, UK.'}, {'ForeName': 'Sharadah', 'Initials': 'S', 'LastName': 'Essapen', 'Affiliation': ""St Luke's Cancer Centre, Royal Surrey County Hospital NHS Foundation Trust, Guildford, UK.""}, {'ForeName': 'Amandeep S', 'Initials': 'AS', 'LastName': 'Dhadda', 'Affiliation': 'Castle Hill Hospital, Hull, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Harrison', 'Affiliation': 'Mount Vernon Cancer Centre, Northwood, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Falk', 'Affiliation': 'Bristol Cancer Institute, Bristol, UK.'}, {'ForeName': 'Sherif', 'Initials': 'S', 'LastName': 'Raouf', 'Affiliation': 'Barking Havering and Redbridge University Hospital NHS Trust, Barking, UK.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Rees', 'Affiliation': 'Southampton University Hospital NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Rene K', 'Initials': 'RK', 'LastName': 'Olesen', 'Affiliation': 'Department of Oncology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Propper', 'Affiliation': 'Barts Cancer Institute, Queen Mary University of London, London, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Bridgewater', 'Affiliation': 'Department of Oncology, University College London, London, UK.'}, {'ForeName': 'Ashraf', 'Initials': 'A', 'LastName': 'Azzabi', 'Affiliation': 'Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Farrugia', 'Affiliation': 'Gloucestershire Oncology Centre, Cheltenham General Hospital, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Webb', 'Affiliation': 'Brighton and Sussex University Hospital Trust, Brighton, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cunningham', 'Affiliation': 'Royal Marsden NHS Foundation Trust, London, UK.'}, {'ForeName': 'Tamas', 'Initials': 'T', 'LastName': 'Hickish', 'Affiliation': 'Poole Hospital NHS Foundation Trust, Poole, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Weaver', 'Affiliation': 'Department of Oncology, Oxford University Hospitals Foundation Trust, Oxford, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Gollins', 'Affiliation': 'North Wales Cancer Treatment Centre, Rhyl, UK.'}, {'ForeName': 'Harpreet', 'Initials': 'H', 'LastName': 'Wasan', 'Affiliation': 'Hammersmith Hospital, Imperial College Healthcare NHS Trust, London, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Paul', 'Affiliation': 'The Christie Hospital NHS Foundation Trust, Manchester, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta23640']
608,31852697,Informed Health Choices media intervention for improving people's ability to critically appraise the trustworthiness of claims about treatment effects: a mixed-methods process evaluation of a randomised trial in Uganda.,"We developed the Informed Health Choices podcast to improve people's ability to assess claims about the effects of treatments. We evaluated the effects of the podcast in a randomised trial.
OBJECTIVES


We conducted this process evaluation to assess the fidelity of the intervention, identify factors that affected the implementation and impact of the intervention and could affect scaling up, and identify potential adverse and beneficial effects.
SETTING


The study was conducted in central Uganda in rural, periurban and urban settings.
PARTICIPANTS


We collected data on parents who were in the intervention arm of the Informed Health Choices study that evaluated an intervention to improve parents' ability to assess treatment effects.
PROCEDURES


We conducted 84 semistructured interviews during the intervention, 19 in-depth interviews shortly after, two focus group discussions with parents, one focus group discussion with research assistants and two in-depth interviews with the principal investigators. We used framework analysis to manage qualitative data, assessed the certainty of the findings using the GRADE-CERQual (Grading of Recommendations, Assessment, Development and Evaluations-Confidence in the Evidence from Reviews of Qualitative Research) approach, and organised findings in a logic model.
OUTCOMES


Proportion of participants listening to all episodes; factors influencing the implementation of the podcast; ways to scale up and any adverse and beneficial effects.
RESULTS


All participants who completed the study listened to the podcast as intended, perhaps because of the explanatory design and recruitment of parents with a positive attitude. This was also likely facilitated by the podcast being delivered by research assistants, and providing the participants with MP3 players. The podcast was reportedly clear, understandable, credible and entertaining, which motivated them to listen and eased implementation. No additional adverse effects were reported.
CONCLUSIONS


Participants experienced the podcast positively and were motivated to engage with it. These findings help to explain the short-term effectiveness of the intervention, but not the decrease in effectiveness over the following year.",2019,"No additional adverse effects were reported.
","['The study was conducted in central Uganda in rural, periurban and urban settings', 'participants with MP3 players', 'We collected data on parents who were in the intervention arm of the Informed Health Choices study']",[],"['adverse and beneficial effects', 'adverse effects']","[{'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C2350433', 'cui_str': 'MP3-Player'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",[],"[{'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",84.0,0.0909602,"No additional adverse effects were reported.
","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Semakula', 'Affiliation': 'Makerere University College of Health Sciences, Kampala, Uganda.'}, {'ForeName': 'Allen', 'Initials': 'A', 'LastName': 'Nsangi', 'Affiliation': 'Makerere University College of Health Sciences, Kampala, Uganda.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Oxman', 'Affiliation': 'Norwegian Institute of Public Health, Oslo, Norway oxman@online.no.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Glenton', 'Affiliation': 'Norwegian Institute of Public Health, Oslo, Norway.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Lewin', 'Affiliation': 'Norwegian Institute of Public Health, Oslo, Norway.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Rosenbaum', 'Affiliation': 'Norwegian Institute of Public Health, Oslo, Norway.'}, {'ForeName': 'Matt', 'Initials': 'M', 'LastName': 'Oxman', 'Affiliation': 'Norwegian Institute of Public Health, Oslo, Norway.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Kaseje', 'Affiliation': 'Tropical Institute of Community Health and Development, Kisumu, Kenya.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Austvoll-Dahlgren', 'Affiliation': 'East and South, Regional Centre for Child and Youth Mental Health and Child Welfare, Oslo, Norway.'}, {'ForeName': 'Christopher James', 'Initials': 'CJ', 'LastName': 'Rose', 'Affiliation': 'Norwegian Institute of Public Health, Oslo, Norway.'}, {'ForeName': 'Atle', 'Initials': 'A', 'LastName': 'Fretheim', 'Affiliation': 'Norwegian Institute of Public Health, Oslo, Norway.'}, {'ForeName': 'Nelson', 'Initials': 'N', 'LastName': 'Sewankambo', 'Affiliation': 'Makerere University College of Health Sciences, Kampala, Uganda.'}]",BMJ open,['10.1136/bmjopen-2019-031510']
609,30380991,Comparison of clinical outcomes after ulnar shortening osteotomy for ulnar impaction syndrome with or without arthroscopic debridement.,"Forty-four patients who had been diagnosed with ulnar impaction syndrome and who were scheduled to undergo ulnar shortening osteotomy were randomized into two groups, one treated by ulnar shortening osteotomy alone and the other treated by ulnar shortening osteotomy combined with arthroscopic debridement. The response to treatment, including the pain numeric rating scale in an ulnar provocation test and the Disability of the Arm, Shoulder and Hand score was assessed at 3 and 12 months after surgery. The mean pain and disability scores showed significant clinical improvement at the 12-month follow-up in both groups. The pain scores at 3 months of follow-up were significantly better in the ulnar shortening osteotomy with arthroscopic debridement group. However, no significant differences were observed between the two groups in the disability scores at 3 and 12 months, or in the pain scores at 12-month follow-up. We conclude that similar improvements in symptom severity and hand function occurred in the long term in patients both with and without concomitant arthroscopic debridement. This information regarding concomitant arthroscopy could be used in the informed consent discussion with patients scheduled for ulnar shortening osteotomy.  Level of evidence:  II.",2019,The pain scores at 3 months of follow-up were significantly better in the ulnar shortening osteotomy with arthroscopic debridement group.,"['ulnar impaction syndrome with or without arthroscopic debridement', 'Forty-four patients who had been diagnosed with ulnar impaction syndrome and who were scheduled to undergo ulnar shortening osteotomy']","['ulnar shortening osteotomy', 'ulnar shortening osteotomy alone and the other treated by ulnar shortening osteotomy combined with arthroscopic debridement']","['pain scores', 'symptom severity and hand function', 'mean pain and disability scores', 'pain numeric rating scale in an ulnar provocation test and the Disability of the Arm, Shoulder and Hand score', 'disability scores']","[{'cui': 'C3532252', 'cui_str': 'Ulnar impingement syndrome'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0442044', 'cui_str': 'Ulnar (qualifier value)'}, {'cui': 'C1282927', 'cui_str': 'Shortened (qualifier value)'}, {'cui': 'C0029468', 'cui_str': 'Osteotomy'}]","[{'cui': 'C0442044', 'cui_str': 'Ulnar (qualifier value)'}, {'cui': 'C1282927', 'cui_str': 'Shortened (qualifier value)'}, {'cui': 'C0029468', 'cui_str': 'Osteotomy'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0562230', 'cui_str': 'Hand functions (observable entity)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0442044', 'cui_str': 'Ulnar (qualifier value)'}, {'cui': 'C0449428', 'cui_str': 'Provocation (attribute)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0018563', 'cui_str': 'Hand'}]",,0.0250552,The pain scores at 3 months of follow-up were significantly better in the ulnar shortening osteotomy with arthroscopic debridement group.,"[{'ForeName': 'Young Hak', 'Initials': 'YH', 'LastName': 'Roh', 'Affiliation': '1 Department of Orthopaedic Surgery, Ewha Womans University Medical Center, Ewha Womans University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Jun Hoe', 'Initials': 'JH', 'LastName': 'Song', 'Affiliation': '1 Department of Orthopaedic Surgery, Ewha Womans University Medical Center, Ewha Womans University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Hyun Sik', 'Initials': 'HS', 'LastName': 'Gong', 'Affiliation': '2 Department of Orthopaedic Surgery, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Sungnam, South Korea.'}, {'ForeName': 'Goo Hyun', 'Initials': 'GH', 'LastName': 'Baek', 'Affiliation': '3 Department of Orthopaedic Surgery, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, South Korea.'}]","The Journal of hand surgery, European volume",['10.1177/1753193418808160']
610,31544231,Development of a Disease Progression Model for Leucine-Rich Repeat Kinase 2 in Parkinson's Disease to Inform Clinical Trial Designs.,"A quantitative assessment of Parkinson's disease (PD) progression is critical for optimizing clinical trials design. Disease progression model was developed using pooled data from the Progression Marker Initiative study and the Incidence of Cognitive Impairment in Cohorts with Longitudinal Evaluation in Parkinson's Disease study. Age, gender, concomitant medication, and study arms were predictors of baseline. A mutation in the leucine-rich repeat kinase 2 (LRRK2) encoding gene was associated with the disease progression rate. The progression rate in subjects with PD who carried LRRK2 mutation was slightly slower (~0.170 points/month) than that in PD subjects without the mutation (~0.222 points/month). For a nonenriched placebo-controlled clinical trial, approximately 70 subjects/arm would be required to detect a drug effect of 50% reduction in the progression rate with 80% probability, whereas 85, 93, and 100 subjects/arm would be required for an enriched clinical trial with 30%, 50%, and 70% subjects with LRRK2 mutations, respectively.",2020,A mutation in the leucine-rich repeat kinase 2 (LRRK2) encoding gene was associated with the disease progression rate.,[],['placebo'],['progression rate'],[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}]",100.0,0.0864223,A mutation in the leucine-rich repeat kinase 2 (LRRK2) encoding gene was associated with the disease progression rate.,"[{'ForeName': 'Malidi', 'Initials': 'M', 'LastName': 'Ahamadi', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Daniela J', 'Initials': 'DJ', 'LastName': 'Conrado', 'Affiliation': 'Critical Path Institute, Tucson, Arizona, USA.'}, {'ForeName': 'Sreeraj', 'Initials': 'S', 'LastName': 'Macha', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Vikram', 'Initials': 'V', 'LastName': 'Sinha', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Stone', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Jackson', 'Initials': 'J', 'LastName': 'Burton', 'Affiliation': 'Critical Path Institute, Tucson, Arizona, USA.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Nicholas', 'Affiliation': 'Pfizer, Groton, Connecticut, USA.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Gallagher', 'Affiliation': ""Parkinson's UK, London, UK.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Dexter', 'Affiliation': ""Parkinson's UK, London, UK.""}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Bani', 'Affiliation': 'UCB, Brussels, Belgium.'}, {'ForeName': 'Babak', 'Initials': 'B', 'LastName': 'Boroojerdi', 'Affiliation': 'UCB, Brussels, Belgium.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Smit', 'Affiliation': 'UCB, Brussels, Belgium.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Weidemann', 'Affiliation': 'Lundbeck, Copenhagen, Denmark.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'GSK UK, Uxbridge, UK.'}, {'ForeName': 'Minhua', 'Initials': 'M', 'LastName': 'Yang', 'Affiliation': 'Biogen, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Romeo', 'Initials': 'R', 'LastName': 'Maciuca', 'Affiliation': 'Denali Therapeutics Inc., San Francisco, California, USA.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Lawson', 'Affiliation': ""Incidence of Cognitive Impairment in Cohorts with Longitudinal Evaluation in Parkinson's Disease, Newcastle University, Newcastle upon Tyne, UK.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Burn', 'Affiliation': ""Incidence of Cognitive Impairment in Cohorts with Longitudinal Evaluation in Parkinson's Disease, Newcastle University, Newcastle upon Tyne, UK.""}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Marek', 'Affiliation': 'Institute of Neurodegenerative Diseases, New Haven, Connecticut, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Venuto', 'Affiliation': 'University of Rochester, Rochester, New York, USA.'}, {'ForeName': 'Bob', 'Initials': 'B', 'LastName': 'Stafford', 'Affiliation': 'Critical Path Institute, Tucson, Arizona, USA.'}, {'ForeName': 'Mussie', 'Initials': 'M', 'LastName': 'Akalu', 'Affiliation': 'Critical Path Institute, Tucson, Arizona, USA.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Stephenson', 'Affiliation': 'Critical Path Institute, Tucson, Arizona, USA.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Romero', 'Affiliation': 'Critical Path Institute, Tucson, Arizona, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical pharmacology and therapeutics,['10.1002/cpt.1634']
611,30189281,A Randomized Trial Comparing Bilateral Lateral Rectus Recession versus Unilateral Recess and Resect for Basic-Type Intermittent Exotropia.,"PURPOSE


To compare long-term outcomes after bilateral lateral rectus recession (BLRc) or unilateral lateral rectus recession combined with medial rectus resection in the same eye (R&R) for primary treatment of childhood intermittent exotropia (IXT).
DESIGN


Multicenter, randomized clinical trial.
PARTICIPANTS


One hundred ninety-seven children 3 to younger than 11 years of age with basic-type IXT, a largest deviation by prism and alternate cover test at any distance of 15 to 40 prism diopters (PD), and near stereoacuity of at least 400 seconds of arc.
METHODS


Random assignment to BLRc or R&R and masked examinations conducted every 6 months after surgery for 3 years.
MAIN OUTCOME MEASURES


Proportion of participants meeting suboptimal surgical outcome by 3 years, defined as: (1) exotropia of 10 PD or more at distance or near using simultaneous prism and cover test (SPCT); or (2) constant esotropia of 6 PD or more at distance or near using SPCT; (3) loss of 2 octaves or more of stereoacuity from baseline, at any masked examination; or (4) reoperation without meeting any of these criteria.
RESULTS


Cumulative probability of suboptimal surgical outcome by 3 years was 46% (43/101) in the BLRc group versus 37% (33/96) in the R&R group (treatment group difference of BLRc minus R&R, 9%; 95% confidence interval [CI], -6% to 23%). Reoperation by 3 years occurred in 9 participants (10%) in the BLRc group (8 of 9 met suboptimal surgical outcome criteria) and in 4 participants (5%) in the R&R group (3 of 4 met suboptimal surgical outcome criteria; treatment group difference of BLRc minus R&R, 5%; 95% CI, -2% to 13%). Among participants completing the 3-year visit, 29% (25 of 86) in the BLRc group and 17% (13 of 77) in the R&R group underwent reoperation or met suboptimal surgical outcome criteria at 3 years (treatment group difference of BLRc minus R&R, 12%; 95% CI, -1% to 25%).
CONCLUSIONS


We did not find a statistically significant difference in suboptimal surgical outcome by 3 years between children with IXT treated with BLRc compared with those treated with R&R. Based on these findings, we are unable to recommend one surgical approach over the other for childhood IXT.",2019,"We did not find a statistically significant difference in suboptimal surgical outcome by 3 years between children with IXT treated with BLRc compared with those treated with R&R. Based on these findings, we are unable to recommend one surgical approach over the other for childhood IXT.","['primary treatment of childhood intermittent exotropia (IXT', 'One hundred ninety-seven children 3 to younger than 11 years of age with basic-type IXT, a largest deviation by prism and alternate cover test at any distance of 15 to 40 prism diopters (PD), and near stereoacuity of at least 400 seconds of arc']","['bilateral lateral rectus recession (BLRc) or unilateral lateral rectus recession combined with medial rectus resection', 'Bilateral Lateral Rectus Recession versus Unilateral Recess and Resect for Basic-Type Intermittent Exotropia']","['suboptimal surgical outcome', 'Reoperation', 'Cumulative probability of suboptimal surgical outcome', 'suboptimal surgical outcome by 3 years, defined as: (1) exotropia of 10 PD or more at distance or near using simultaneous prism and cover test (SPCT); or (2) constant esotropia of 6 PD or more at distance or near using SPCT; (3) loss of 2 octaves or more of stereoacuity']","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C0423062', 'cui_str': 'Intermittent exotropia (disorder)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439073', 'cui_str': '97 (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0012727', 'cui_str': 'Displacement (morphologic abnormality)'}, {'cui': 'C1302981', 'cui_str': 'Prism and alternate cover test'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0439487', 'cui_str': 'prism diopters'}, {'cui': 'C0475806', 'cui_str': 'Nr - Near'}, {'cui': 'C1275505', 'cui_str': 'Stereoscopic acuity (observable entity)'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0439491', 'cui_str': 'seconds of arc (qualifier value)'}]","[{'cui': 'C0395290', 'cui_str': 'Bilateral lateral rectus recession (procedure)'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0395310', 'cui_str': 'Lateral rectus recession (procedure)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0395297', 'cui_str': 'Medial rectus resection (procedure)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0423062', 'cui_str': 'Intermittent exotropia (disorder)'}]","[{'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0035110', 'cui_str': 'Revision Surgery'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0015310', 'cui_str': 'Strabismus, Divergent'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0475806', 'cui_str': 'Nr - Near'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C1302981', 'cui_str': 'Prism and alternate cover test'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0014877', 'cui_str': 'Strabismus, Internal'}, {'cui': 'C1275505', 'cui_str': 'Stereoscopic acuity (observable entity)'}]",197.0,0.20163,"We did not find a statistically significant difference in suboptimal surgical outcome by 3 years between children with IXT treated with BLRc compared with those treated with R&R. Based on these findings, we are unable to recommend one surgical approach over the other for childhood IXT.","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Sean P', 'Initials': 'SP', 'LastName': 'Donahue', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, Vanderbilt University Medical Center, Nashville, Tennessee. Electronic address: pedig.@jaeb.org.'}, {'ForeName': 'Danielle L', 'Initials': 'DL', 'LastName': 'Chandler', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Holmes', 'Affiliation': 'Department of Ophthalmology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Brian W', 'Initials': 'BW', 'LastName': 'Arthur', 'Affiliation': ""Department of Ophthalmology, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'Evelyn A', 'Initials': 'EA', 'LastName': 'Paysse', 'Affiliation': ""Section of Ophthalmology, Texas Children's Hospital, Houston, Texas.""}, {'ForeName': 'David K', 'Initials': 'DK', 'LastName': 'Wallace', 'Affiliation': 'Department of Ophthalmology, Indiana University, Indianapolis, Indiana.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Petersen', 'Affiliation': 'Rocky Mountain Eye Care Associates, Salt Lake City, Utah.'}, {'ForeName': 'B Michele', 'Initials': 'BM', 'LastName': 'Melia', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'Raymond T', 'Initials': 'RT', 'LastName': 'Kraker', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'Aaron M', 'Initials': 'AM', 'LastName': 'Miller', 'Affiliation': 'Houston Eye Associates, Houston, Texas.'}]",Ophthalmology,['10.1016/j.ophtha.2018.08.034']
612,31984502,Growing Together-Effects of a school-based intervention promoting positive self-beliefs and social integration in recently immigrated children.,"We present a school-based intervention geared to foster the social integration of recently immigrated (RI) primary school children by creating repeated positive contact situations with classmates brought up in the receiving society. Coaches encouraged groups of tandems, consisting of one RI and one child brought up in Germany each, to engage in cooperative activities designed to strengthen positive self-beliefs and perception of equal status. In a quasi-experimental control-group design (N = 318), we compared the 30 children (12 RI) who participated in our intervention between pre-test and post-test with a reference group. Self-beliefs were measured via self-reports, social integration via sociometric peer-nominations. The reference group (n = 288 children) included all children who did not participate in the intervention between pre-test and post-test: (a) 12 children (7 RI) of a waiting control group and (b) all classmates of both the students of the intervention and the waiting control group. Post-test self-beliefs were more positive in children having participated in the intervention. The intervention did not affect social integration: Neither the number of classmates nominating a student nor the number of peers the respective student nominated increased. Possibly, the intervention initiated self-reinforcing processes which support social integration over longer time periods.",2020,We present a school-based intervention geared to foster the social integration of recently immigrated (RI) primary school children by creating repeated positive contact situations with classmates brought up in the receiving society.,"['30 children (12 RI) who participated in our intervention between pre-test and post-test with a reference group', 'recently immigrated children', 'The reference group (n = 288 children) included all children who did not participate in the intervention between pre-test and post-test: (a) 12 children (7 RI) of a waiting control group and (b) all classmates of both the students of the intervention and the waiting control group']",['school-based intervention'],"['Self-beliefs', 'number of classmates nominating a student nor the number of peers the respective student nominated increased', 'social integration']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",288.0,0.015598,We present a school-based intervention geared to foster the social integration of recently immigrated (RI) primary school children by creating repeated positive contact situations with classmates brought up in the receiving society.,"[{'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Hannover', 'Affiliation': 'Fachbereich Erziehungswissenschaft und Psychologie, Freie Universität Berlin, Berlin, Germany.'}, {'ForeName': 'Madeleine', 'Initials': 'M', 'LastName': 'Kreutzmann', 'Affiliation': 'Fachbereich Erziehungswissenschaft und Psychologie, Freie Universität Berlin, Berlin, Germany.'}, {'ForeName': 'Jannika', 'Initials': 'J', 'LastName': 'Haase', 'Affiliation': 'Fachbereich Erziehungswissenschaft und Psychologie, Freie Universität Berlin, Berlin, Germany.'}, {'ForeName': 'Lysann', 'Initials': 'L', 'LastName': 'Zander', 'Affiliation': 'Institut für Erziehungswissenschaft, Leibniz University Hannover, Hanover, Germany.'}]",International journal of psychology : Journal international de psychologie,['10.1002/ijop.12653']
613,31505228,A Phase 3 Randomized Study of Remestemcel-L versus Placebo Added to Second-Line Therapy in Patients with Steroid-Refractory Acute Graft-versus-Host Disease.,"Uncontrolled studies have suggested that bone marrow-derived mesenchymal stem cells (MSCs) may be effective against acute graft-versus-host disease (aGVHD). We conducted a multicenter, randomized study to assess the efficacy of using ex vivo cultured adult human MSC (remestemcel-L) in addition to second-line therapy to treat steroid-refractory aGVHD (NCT00366145). In total, 260 patients, 6 months to 70 years of age, were enrolled from August 2006 to May 2009 and were randomized 2:1 to receive 8 intravenous infusions of remestemcel-L or placebo, given over 4 weeks, in addition to second-line therapy according to institutional standards. Four additional infusions over 4 weeks were indicated for patients with incomplete response at day 28. Randomization was stratified by aGVHD grade. Efficacy and safety were assessed through 180 days of follow-up, with the primary endpoint being durable complete response (DCR), defined as complete resolution of aGVHD symptoms for any period of at least 28 days after beginning treatment. Remestemcel-L did not meet the primary endpoint of greater DCR in the intent-to-treat population (35% versus 30%; P = 0.42). In post hoc analyses, patients with liver involvement who received at least 1 infusion of remestemcel-L had a higher DCR, and higher overall complete or partial response rate (OR) than those who received placebo (29% versus 5%; P = .047). Among high-risk patients (aGVHD grades C and D), remestemcel-L demonstrated significantly higher OR at day 28 than placebo (58% versus 37%; P = 0.03). Furthermore, pediatric patients had a higher OR with MSCs compared with placebo (64% versus 23%; P = .05). Similar rates of adverse events were observed between treatment groups. Remestemcel-L was safe and well tolerated. Results of this study did not demonstrate superior DCR compared with placebo when added to standard of care. The favorable clinical responses seen in some patient subsets may warrant further investigation.",2020,"Furthermore, pediatric patients had a higher OR with MSCs compared with placebo (64% versus 23%; P = .05).","['260 patients, 6 months to 70 years of age, were enrolled from August 2006 to May 2009', 'Patients with Steroid-Refractory Acute Graft-versus-Host Disease']","['placebo', 'ex vivo cultured adult human MSC (remestemcel-L', 'Remestemcel-L versus Placebo Added to Second-Line Therapy', 'intravenous infusions of remestemcel-L or placebo']","['overall complete or partial response rate (OR', 'adverse events', 'durable complete response (DCR), defined as complete resolution of aGVHD symptoms', 'Efficacy and safety', 'safe and well tolerated']","[{'cui': 'C4517669', 'cui_str': 'Two hundred and sixty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0856825', 'cui_str': 'Acute graft-versus-host disease (disorder)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0220814', 'cui_str': 'culture'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0021440', 'cui_str': 'Infusions, Intravenous'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0856825', 'cui_str': 'Acute graft-versus-host disease (disorder)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",260.0,0.32227,"Furthermore, pediatric patients had a higher OR with MSCs compared with placebo (64% versus 23%; P = .05).","[{'ForeName': 'Partow', 'Initials': 'P', 'LastName': 'Kebriaei', 'Affiliation': 'Department of Stem Cell and Cellular Therapy, University of Texas MD Anderson Cancer Center, Houston, Texas. Electronic address: pkebriae@mdanderson.org.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Hayes', 'Affiliation': 'Mesoblast, New York, New York.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Daly', 'Affiliation': 'Tom Baker Cancer Center, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Uberti', 'Affiliation': 'Barbara Ann Karmanos Cancer Institute, Detroit, Michigan.'}, {'ForeName': 'David I', 'Initials': 'DI', 'LastName': 'Marks', 'Affiliation': 'University Hospitals Bristol NHS Foundation Trust, Bristol, United Kingdom.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Soiffer', 'Affiliation': 'Dana-Farber Cancer Institute, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Edmund K', 'Initials': 'EK', 'LastName': 'Waller', 'Affiliation': 'Emory University Bone Marrow and Stem Cell Transplant Center, Atlanta, Georgia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Burke', 'Affiliation': 'Mesoblast, New York, New York.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Skerrett', 'Affiliation': 'Mesoblast, New York, New York.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Shpall', 'Affiliation': 'Department of Stem Cell and Cellular Therapy, University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Martin', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, Washington.'}]",Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation,['10.1016/j.bbmt.2019.08.029']
614,31811950,Genetic Variant Associated With Survival of Patients With Stage II-III Colon Cancer.,"BACKGROUND & AIMS


Many genetic variants have been associated with colorectal cancer risk, although few have been associated with survival times of patients. Identification of genetic variants associated with survival times might improve our understanding of disease progression and aid in outcome prediction. We performed a genome-wide association study to identify variants associated with colon cancer survival time.
METHODS


We performed a post hoc analysis of data from NCCTG N0147 (Alliance), a randomized phase 3 trial of patients with resected stage III colon cancer, and from NSABP C-08 (NRG), a phase 3 trial that compared therapy regimens for patients with resected stage II or III colon cancer. Genotype analyses were performed on DNA from blood samples from 4974 patients. We used Cox proportional hazards regression to evaluate the association of each single nucleotide polymorphism with times of overall survival and disease-free survival, adjusting for age at diagnosis, sex, treatment group, and principal components of genetic ancestry. We performed the analysis for studies N0147 and C-08 separately, and results were combined in a fixed-effects meta-analysis.
RESULTS


A locus on chromosome 7p15.2 was significantly associated with overall survival time (P ≤ 5x10 -08 ). The most significant variant at this locus, rs76766811 (P = 1.6x10 -08 ), is common among African Americans (minor allele frequency, approximately 18%) but rare in European Americans (minor allele frequency <0.1%). Within strata of self-reported ancestry, this variant was associated with times of overall survival and disease-free survival in only African Americans (hazard ratio for overall survival, 2.82; 95% CI, 1.88-4.23; P = 5.0x10 -07  and hazard ratio for disease-free survival, 2.27; 95% CI, 1.62-3.18; P = 1.8x10 -06 ).
CONCLUSIONS


In an analysis of data from 2 trials of patients with stage II or III colon cancer, we identified rs76766811 as a potential prognostic variant in African American patients. This finding should be confirmed in additional study populations. ClinicalTrials.gov Identifiers: NCT00096278 (NSABP C-08) and NCT00079274 (NCCTG N0147).",2020,A locus on chromosome 7p15.2 was significantly associated with overall survival time (P≤5x10 -08 ).,"['African American patients', '4974 patients', 'patients with resected stage III colon cancer, and from NSABP C-08 (NRG), a phase 3 trial that compared therapy regimens for patients with resected stage II or III colon cancer', 'patients with stage II or III colon cancer', 'Patients with Stage II-III Colon Cancer']",[],"['overall survival time', 'overall survival and disease-free survival', 'colon cancer survival time']","[{'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0007102', 'cui_str': 'Cancer of Colon'}, {'cui': 'C0439561', 'cui_str': 'Phase 3 (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}]",[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0007102', 'cui_str': 'Cancer of Colon'}]",4974.0,0.294248,A locus on chromosome 7p15.2 was significantly associated with overall survival time (P≤5x10 -08 ).,"[{'ForeName': 'Kathryn L', 'Initials': 'KL', 'LastName': 'Penney', 'Affiliation': ""Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts; Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, Massachusetts.""}, {'ForeName': 'Barbara L', 'Initials': 'BL', 'LastName': 'Banbury', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Bien', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Tabitha A', 'Initials': 'TA', 'LastName': 'Harrison', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Xinwei', 'Initials': 'X', 'LastName': 'Hua', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, Washington; University of Washington, Seattle, Washington.'}, {'ForeName': 'Amanda I', 'Initials': 'AI', 'LastName': 'Phipps', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, Washington; University of Washington, Seattle, Washington.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Sun', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Mingyang', 'Initials': 'M', 'LastName': 'Song', 'Affiliation': 'Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, Massachusetts; Clinical and Translational Epidemiology Unit, Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts; Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, Massachusetts; Division of Gastroenterology, Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Amit D', 'Initials': 'AD', 'LastName': 'Joshi', 'Affiliation': 'Clinical and Translational Epidemiology Unit, Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Steven R', 'Initials': 'SR', 'LastName': 'Alberts', 'Affiliation': 'Department of Health Science Research, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Carmen J', 'Initials': 'CJ', 'LastName': 'Allegra', 'Affiliation': 'University of Florida, Gainesville, Florida; NRG Oncology, Pittsburgh, Pennsylvania.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Atkins', 'Affiliation': 'NRG Oncology, Pittsburgh, Pennsylvania; Southeast Clinical Oncology Research (SCOR) Consortium NCORP, Winston-Salem, North Carolina.'}, {'ForeName': 'Linda H', 'Initials': 'LH', 'LastName': 'Colangelo', 'Affiliation': 'NRG Oncology, Pittsburgh, Pennsylvania; University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'George', 'Affiliation': 'University of Florida, Gainesville, Florida; NRG Oncology, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Goldberg', 'Affiliation': 'NRG Oncology, Pittsburgh, Pennsylvania; West Virginia University Cancer Institute, Morgantown, West Virginia.'}, {'ForeName': 'Peter C', 'Initials': 'PC', 'LastName': 'Lucas', 'Affiliation': 'NRG Oncology, Pittsburgh, Pennsylvania; University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Suresh G', 'Initials': 'SG', 'LastName': 'Nair', 'Affiliation': 'Lehigh Valley Hospital-Cedar Crest, Allentown, Pennsylvania.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Shi', 'Affiliation': 'Department of Health Science Research, Mayo Clinic, Rochester, Minnesota; Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Frank A', 'Initials': 'FA', 'LastName': 'Sinicrope', 'Affiliation': 'Department of Health Science Research, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Wolmark', 'Affiliation': 'NRG Oncology, Pittsburgh, Pennsylvania; Allegheny Health Network Cancer Institute, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Yothers', 'Affiliation': 'NRG Oncology, Pittsburgh, Pennsylvania; University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Peters', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, Washington; University of Washington, Seattle, Washington.'}, {'ForeName': 'Polly A', 'Initials': 'PA', 'LastName': 'Newcomb', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, Washington; University of Washington, Seattle, Washington.'}, {'ForeName': 'Andrew T', 'Initials': 'AT', 'LastName': 'Chan', 'Affiliation': ""Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts; Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, Massachusetts; Clinical and Translational Epidemiology Unit, Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts; Division of Gastroenterology, Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts. Electronic address: achan@mgh.harvard.edu.""}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2019.11.046']
615,31898323,Does forgiving in a collectivistic culture affect only decisions to forgive and not emotions? REACH forgiveness collectivistic in Indonesia.,"According to some theorising, in collectivistic societies, forgiveness is mainly enacted to maintain relationships, not engender emotional transformation. This present study was designed to explore whether forgiveness affects decisional and emotional forgiveness in Indonesia, a country categorised as collectivistic. The evidence-based REACH Forgiveness psychoeducational group intervention was adapted to collectivistic culture (REACH forgiveness collectivistic; REACH-FC), and its efficacy was assessed in a randomised controlled trial. Undergraduates in Indonesia (N = 97; 24 male; 73 female; ages 16-21) were randomly assigned within a 2 × 3(S) quasi-experimental repeated-measures design comparing immediate treatment (IT) and waiting list (WL) conditions [Condition (IT, WL) × Time ([S] 3 time points). Harmonious value, a personality variable assessing the strength of participants' desire for group harmony, was the covariate. The condition × time (S) interactions for both decisional and emotional forgiveness were significant, challenging some previous literature. Clearly, not all forms of collectivism have similar effects when individuals and communities deal with transgressions.",2020,"The condition × time (S) interactions for both decisional and emotional forgiveness were significant, challenging some previous literature.",['Undergraduates in Indonesia (N\xa0=\xa097; 24 male; 73 female; ages 16-21'],"['2\u2009×\u20093(S) quasi-experimental repeated-measures design comparing immediate treatment (IT) and waiting list (WL) conditions [Condition (IT, WL)\u2009×\u2009Time']",[],"[{'cui': 'C0021247', 'cui_str': 'East Indies'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",[],73.0,0.0424285,"The condition × time (S) interactions for both decisional and emotional forgiveness were significant, challenging some previous literature.","[{'ForeName': 'Ni Made Taganing', 'Initials': 'NMT', 'LastName': 'Kurniati', 'Affiliation': 'Faculty of Psychology, Universitas Gunadarma, Depok, Indonesia.'}, {'ForeName': 'Everett L', 'Initials': 'EL', 'LastName': 'Worthington', 'Affiliation': 'Department of Psychology, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Nilam', 'Initials': 'N', 'LastName': 'Widyarini', 'Affiliation': 'Faculty of Psychology, Universitas Gunadarma, Depok, Indonesia.'}, {'ForeName': 'Ajeng Furida', 'Initials': 'AF', 'LastName': 'Citra', 'Affiliation': 'Faculty of Psychology, Universitas Gunadarma, Depok, Indonesia.'}, {'ForeName': 'Carissa', 'Initials': 'C', 'LastName': 'Dwiwardani', 'Affiliation': 'Department of Psychology, Azusa Pacific University, Azusa, CA, USA.'}]",International journal of psychology : Journal international de psychologie,['10.1002/ijop.12648']
616,31971616,Closure of the fascial defect during laparoscopic umbilical hernia repair: a randomized clinical trial.,"BACKGROUND


The objective of the study was to analyse patient-reported outcome measures (PROMs), seroma formation, long-term recurrence and chronic pain after closure of the fascial defect in patients undergoing laparoscopic umbilical hernia mesh repair.
METHODS


This was a randomized double-blinded trial in patients undergoing elective laparoscopic umbilical hernia repair comparing sutured closure of the fascial defect before intraperitoneal onlay mesh (IPOM) repair with a no-closure IPOM repair. Postoperative pain, movement limitations, discomfort and fatigue were registered before surgery and on postoperative days 1-3, 7 and 30. Seroma formation, quality of life and cosmesis were assessed at day 30, and at 2 years of follow-up. Recurrence (clinical and reoperation) and chronic pain were assessed after 2 years.
RESULTS


Eighty patients were randomized. Median defect sizes in closure and no-closure groups were 2·5 (range 1·5-4·0) and 2·5 (2·0-5·5) cm respectively (P = 0·895). There were no significant differences in early and late postoperative pain or in any other early or late PROMs, except for early fatigue which was higher in the closure group (P = 0·011). Seroma formation after 30 days was significantly reduced after closure (14 of 40; 35 (95 per cent c.i. 22 to 51) per cent) compared with no closure (22 of 38; 58 (42 to 72) per cent) (P = 0·043). Cumulative recurrence after 2 years was lower in the closure group: 5 of 36 (7 (3 to 17) per cent) versus 12 of 37 (19 (10 to 33) per cent) for no closure (P = 0·047).
CONCLUSION


Closure of the fascial defect in laparoscopic umbilical hernia IPOM repair significantly reduced early seroma formation and long-term recurrence without inducing side-effects such as pain, or other early or late PROMs. Registration number: NCT01962480 ( https://www.clinicaltrials.gov).",2020,Seroma formation after 30 days was significantly reduced after closure (14 of 40; 35 (95 per cent c.i.,"['Eighty patients were randomized', 'patients undergoing', 'patients undergoing laparoscopic umbilical hernia mesh repair']","['laparoscopic umbilical hernia repair', 'elective laparoscopic umbilical hernia repair comparing sutured closure of the fascial defect before intraperitoneal onlay mesh (IPOM) repair with a no-closure IPOM repair']","['early and late postoperative pain', 'Recurrence (clinical and reoperation) and chronic pain', 'early seroma formation and long-term recurrence', 'Postoperative pain, movement limitations, discomfort and fatigue', 'Median defect sizes', 'Cumulative recurrence', 'outcome measures (PROMs), seroma formation, long-term recurrence and chronic pain', 'Seroma formation, quality of life and cosmesis', 'Seroma formation']","[{'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306503', 'cui_str': 'Exomphalos'}, {'cui': 'C0181805', 'cui_str': 'Mesh (physical object)'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}]","[{'cui': 'C0019333', 'cui_str': 'Repair of umbilical hernia (procedure)'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}, {'cui': 'C0015641', 'cui_str': 'Fascia'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0442120', 'cui_str': 'Intraperitoneal (qualifier value)'}, {'cui': 'C0677511', 'cui_str': 'Onlay (qualifier value)'}, {'cui': 'C0181805', 'cui_str': 'Mesh (physical object)'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0035110', 'cui_str': 'Revision Surgery'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0262627', 'cui_str': 'Seroma'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0449295', 'cui_str': 'Limitation (attribute)'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0034380'}]",80.0,0.649892,Seroma formation after 30 days was significantly reduced after closure (14 of 40; 35 (95 per cent c.i.,"[{'ForeName': 'M W', 'Initials': 'MW', 'LastName': 'Christoffersen', 'Affiliation': 'Gastro Unit, Surgical Section, Centre for Surgical Research, Hvidovre Hospital.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Westen', 'Affiliation': 'Gastro Unit, Surgical Section, Centre for Surgical Research, Hvidovre Hospital.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Rosenberg', 'Affiliation': 'Herlev Hospital, University of Copenhagen, Copenhagen.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Helgstrand', 'Affiliation': 'Department of Surgery, Zealand University Hospital, Køge, Denmark.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Bisgaard', 'Affiliation': 'Gastro Unit, Surgical Section, Centre for Surgical Research, Hvidovre Hospital.'}]",The British journal of surgery,['10.1002/bjs.11490']
617,32143877,"A randomized controlled trial on inspiratory muscle training in pulmonary hypertension: Effects on respiratory functions, functional exercise capacity, physical activity, and quality of life.","BACKGROUND


Impaired respiratory muscle function may be one of the causes of increased dyspnea, reduced exercise capacity, and physical activity (PA), and poor quality of life in pulmonary hypertension (PH).
OBJECTIVE


To investigate the effects of threshold inspiratory muscle training (TIMT) on respiratory functions, functional exercise capacity, PA, and QoL in patients with PH.
METHODS


Thirty patients with PH were randomly allocated to a TIMT (n = 15) and sham group (n = 15). Three patients in the sham group could not participate in the program. The TIMT group (n = 15) trained at 30% of the maximal inspiratory pressure (MIP), and the sham group (n = 12) performed at lowest pressure without change in threshold pressure. In both groups, patients performed TIMT at home for 15 min, twice per day, with the MIP load determined by the trainer, and were supervised once weekly at the hospital for eight weeks. The primary outcomes were MIP and maximal expiratory pressure (MEP). The secondary outcome measures included spirometric measurements, six-minute walking distance (6MWD), PA (SenseWear armband and International Physical Activity Questionnaire-Short Form-IPAQ-Short Form), and QoL (Minnesota Living with Heart Failure-MLHF).
RESULTS


After the training, changes in MIP (p = 0.023) were higher in the intervention group compared with the sham group. Differences in MEP, FEV1 (%), FVC (%), FEV1/FVC (%), 6MWD, %6MWD, IPAQ-SF, MLHFQ, and armband parameters were not significantly different between the groups (p > 0.05).
CONCLUSIONS


The results of the study demonstrated that TIMT could increase MIP and did not improve other parameters of respiratory functions, functional exercise capacity, PA, and QoL in patients with PH.",2020,"After the training, changes in MIP (p = 0.023) were higher in the intervention group compared with the sham group.","['pulmonary hypertension', 'patients with PH.\nMETHODS\n\n\nThirty patients with PH', 'patients with PH']","['inspiratory muscle training', 'threshold inspiratory muscle training (TIMT', 'TIMT']","['respiratory functions, functional exercise capacity, physical activity, and quality of life', 'MIP and maximal expiratory pressure (MEP', 'MEP, FEV1 (%), FVC (%), FEV1/FVC (%), 6MWD, %6MWD, IPAQ-SF, MLHFQ, and armband parameters', 'changes in MIP', 'spirometric measurements, six-minute walking distance (6MWD), PA (SenseWear armband and International Physical Activity Questionnaire-Short Form-IPAQ-Short Form), and QoL (Minnesota Living with Heart Failure-MLHF', 'respiratory functions, functional exercise capacity, PA, and QoL']","[{'cui': 'C1963999', 'cui_str': 'Pulmonary hypertension (SMQ)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C0454511', 'cui_str': 'Inspiratory muscle training (regime/therapy)'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}]","[{'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C0454284', 'cui_str': 'Functional exercises (regime/therapy)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0034380'}, {'cui': 'C4082175', 'cui_str': 'Maximal Expiratory Pressure'}, {'cui': 'C1301852', 'cui_str': 'Armband'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0026183', 'cui_str': 'Minnesota'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}]",30.0,0.0970138,"After the training, changes in MIP (p = 0.023) were higher in the intervention group compared with the sham group.","[{'ForeName': 'Goksen Kuran', 'Initials': 'GK', 'LastName': 'Aslan', 'Affiliation': 'Istanbul University-Cerrahpasa, Faculty of Health Sciences, Division of Physiotherapy and Rehabilitation, Bakırköy, Istanbul, Turkey. Electronic address: goksenkuran@yahoo.com.'}, {'ForeName': 'Buket', 'Initials': 'B', 'LastName': 'Akıncı', 'Affiliation': 'Biruni University, Faculty of Health Sciences, Division of Physiotherapy and Rehabilitation, Istanbul, Turkey. Electronic address: barbuket@hotmail.com.'}, {'ForeName': 'Ipek', 'Initials': 'I', 'LastName': 'Yeldan', 'Affiliation': 'Istanbul University-Cerrahpasa, Faculty of Health Sciences, Division of Physiotherapy and Rehabilitation, Bakırköy, Istanbul, Turkey. Electronic address: ipekyeldan@gmail.com.'}, {'ForeName': 'Gulfer', 'Initials': 'G', 'LastName': 'Okumus', 'Affiliation': 'Istanbul University, Istanbul Faculty of Medicine, Department of Chest Disease, Istanbul, Turkey. Electronic address: gulferokumus@yahoo.com.'}]",Heart & lung : the journal of critical care,['10.1016/j.hrtlng.2020.01.014']
618,29529157,Randomized controlled clinical trial of behavioral lifestyle intervention with partial meal replacement to reduce excessive gestational weight gain.,"Background


Behavioral lifestyle interventions during pregnancy can prevent excessive gestational weight gain (GWG) in women with normal weight; however, effective interventions to reduce GWG in ethnically diverse women with obesity are lacking.
Objective


A randomized controlled trial was conducted to test whether a behavioral lifestyle intervention with partial meal replacement reduces GWG rate in Hispanic and non-Hispanic women with overweight or obesity relative to enhanced usual care.
Design


Participants (n = 257) were recruited in San Luis Obispo, California, and Providence, Rhode Island, between November 2012 and May 2016. Participants were pregnant (mean ± SD: 13.6 ± 1.8 wk of gestation) with overweight or obesity and had a mean age of 30.3 y; 41.6% of participants were Hispanic. Women were randomly assigned within site and by ethnicity to enhanced usual care (n = 128) or to a behavioral lifestyle intervention with partial meal replacement (n = 129). The primary outcome was GWG per week of observation. Secondary outcomes were proportions exceeding Institute of Medicine (IOM) guidelines for total GWG, changes in weight-control behaviors and cardiovascular disease risk factors, and incidence of pregnancy complications. Study retention was 99.6% (256 of 257).
Results


The intervention compared with usual care resulted in less mean ± SD weekly GWG (0.33 ± 0.25 compared with 0.39 ± 0.23 kg/wk; P = 0.02) and total GWG (9.4 ± 6.9 compared with 11.2 ± 7.0 kg; P = 0.03) and reduced the proportion of women who exceeded IOM guidelines for total GWG (41.1% compared with 53.9%; P = 0.03). No significant group × time × demographic subgroup (ethnicity, BMI, age, parity, and income) interactions were observed. Among intervention participants, greater meal replacement intake was related to reduced GWG rate (β = -0.07; 95% CI:-0.12, -0.03; P = 0.002). The intervention compared with usual care increased weight-control strategies (P < 0.0001) and cognitive restraint (P < 0.0001) and reduced triglycerides (P = 0.03).
Conclusion


Prenatal behavioral intervention with partial meal replacement significantly reduced GWG in Hispanic and non-Hispanic women with overweight or obesity. This trial was registered at www.clinicaltrials.gov as NCT01545934.",2018,"The intervention compared with usual care increased weight-control strategies (P < 0.0001) and cognitive restraint (P < 0.0001) and reduced triglycerides (P = 0.03).
","['women with normal weight', 'Participants were pregnant (mean ± SD: 13.6 ± 1.8 wk of gestation) with overweight or obesity and had a mean age of 30.3 y; 41.6% of participants were Hispanic', '257) were recruited in San Luis Obispo, California, and Providence, Rhode Island, between November 2012 and May 2016', 'Design\n\n\nParticipants (n\xa0', 'Hispanic and non-Hispanic women with overweight or obesity relative to enhanced usual care', 'Hispanic and non-Hispanic women with overweight or obesity']","['partial meal replacement significantly reduced GWG', '\n\n\nBehavioral lifestyle interventions', 'ethnicity to enhanced usual care (n\xa0=\xa0128) or to a behavioral lifestyle intervention with partial meal replacement', 'behavioral lifestyle intervention with partial meal replacement']","['reduced triglycerides', 'meal replacement intake', 'excessive gestational weight gain (GWG', 'weight-control strategies', 'time × demographic subgroup (ethnicity, BMI, age, parity, and income) interactions', 'excessive gestational weight gain', 'proportions exceeding Institute of Medicine (IOM) guidelines for total GWG, changes in weight-control behaviors and cardiovascular disease risk factors, and incidence of pregnancy complications', 'cognitive restraint', 'total GWG', 'GWG per week of observation', 'reduced GWG rate', 'proportion of women who exceeded IOM guidelines for total GWG', 'GWG rate', 'mean ± SD weekly GWG']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2712185', 'cui_str': 'Normal weight (finding)'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517560', 'cui_str': '13.6'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0445527', 'cui_str': 'Luis (qualifier value)'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0035487', 'cui_str': 'Rhode Island'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}]","[{'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0243103', 'cui_str': 'ethnicity'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0442802', 'cui_str': 'Excessive (qualifier value)'}, {'cui': 'C1398625', 'cui_str': 'Pregnancy Weight Gain'}, {'cui': 'C0920298', 'cui_str': 'Weight maintenance regimen (regime/therapy)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0243103', 'cui_str': 'ethnicity'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030563', 'cui_str': 'Parity'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0021621', 'cui_str': 'National Academies of Science, Engineering, and Medicine (US) Health and Medicine Division'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1321111', 'cui_str': 'Weight control behavior'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0032962', 'cui_str': 'Pregnancy Complications'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",257.0,0.194475,"The intervention compared with usual care increased weight-control strategies (P < 0.0001) and cognitive restraint (P < 0.0001) and reduced triglycerides (P = 0.03).
","[{'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Phelan', 'Affiliation': 'Departments of Kinesiology, Statistics, and Modern Languages, California Polytechnic State University, San Luis Obispo, CA.'}, {'ForeName': 'Rena R', 'Initials': 'RR', 'LastName': 'Wing', 'Affiliation': 'Department of Psychiatry and Human Behavior, Warren Alpert Medical School at Brown University, Providence, RI.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Brannen', 'Affiliation': 'Departments of Kinesiology, Statistics, and Modern Languages, California Polytechnic State University, San Luis Obispo, CA.'}, {'ForeName': 'Angelica', 'Initials': 'A', 'LastName': 'McHugh', 'Affiliation': 'Department of Psychiatry and Human Behavior, Warren Alpert Medical School at Brown University, Providence, RI.'}, {'ForeName': 'Todd A', 'Initials': 'TA', 'LastName': 'Hagobian', 'Affiliation': 'Departments of Kinesiology, Statistics, and Modern Languages, California Polytechnic State University, San Luis Obispo, CA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Schaffner', 'Affiliation': 'Departments of Statistics, and Modern Languages, California Polytechnic State University, San Luis Obispo, CA.'}, {'ForeName': 'Elissa', 'Initials': 'E', 'LastName': 'Jelalian', 'Affiliation': 'Department of Psychiatry and Human Behavior, Warren Alpert Medical School at Brown University, Providence, RI.'}, {'ForeName': 'Chantelle N', 'Initials': 'CN', 'LastName': 'Hart', 'Affiliation': 'Department of Social and Behavioral Sciences, Temple University Center for Obesity Research and Education, Philadelphia, PA.'}, {'ForeName': 'Theresa O', 'Initials': 'TO', 'LastName': 'Scholl', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Medicine and Dentistry of New Jersey (now Rowan), Glassboro, NJ.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Munoz-Christian', 'Affiliation': 'Departments of Modern Languages, California Polytechnic State University, San Luis Obispo, CA.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Yin', 'Affiliation': ""Pacific Central Coast Health Centers, Santa Maria Women's Health, Santa Maria, CA.""}, {'ForeName': 'Maureen G', 'Initials': 'MG', 'LastName': 'Phipps', 'Affiliation': 'Department of Obstetrics and Gynecology, Warren Alpert Medical School of Brown University and Women and Infants Hospital, Providence, RI.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Keadle', 'Affiliation': 'Departments of Kinesiology, Statistics, and Modern Languages, California Polytechnic State University, San Luis Obispo, CA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Abrams', 'Affiliation': 'Division of Epidemiology, University of California at Berkeley School of Public Health, Berkeley, CA.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqx043']
619,31964579,"Effects of an educational intervention on heart failure knowledge, self-care behaviors, and health-related quality of life of patients with heart failure: Exploring the role of depression.","OBJECTIVES


To test effects of an educational intervention on patient-reported outcomes among rural heart failure (HF) patients and to examine whether effects differed between patients with and without depression.
METHODS


Patients (N = 614) were randomized to usual care (UC) or 1 of 2 intervention groups. Both intervention groups received face-to-face education, followed by either 2 phone calls (LITE) or biweekly calls until they demonstrated content competency (PLUS). Follow-up lasted 24 months. Statistical analyses included linear mixed models and subgroup analyses by depression status.
RESULTS


Both intervention groups showed improvement in HF knowledge at 3 months (LITE-UC, p = 0.003; PLUS-UC, p < 0.001). Improvement lasted 24 months only in the PLUS group. Compared to UC, both intervention groups exhibited better self-care at 3 months (LITE-UC, p < 0.001; PLUS-UC, p < 0.001) and 12 months (LITE-UC, p = 0.001; PLUS-UC, p = 0.002). There were no differences in health-related quality of life (HRQOL) among groups. In subgroup analyses, similar effects were found among non-depressed, but not among depressed patients.
CONCLUSION


The educational intervention improved HF knowledge and self-care, but not HRQOL. No intervention effects were observed in patients with depressive symptoms.
PRACTICE IMPLICATIONS


The simple educational intervention is promising to improve HF knowledge and self-care. Additional strategies are needed for depressed patients.",2020,"Both intervention groups showed improvement in HF knowledge at 3 months (LITE-UC, p = 0.003; PLUS-UC, p < 0.001).","['Patients (N\u202f=\u202f614', 'rural heart failure (HF) patients', 'patients with depressive symptoms', 'patients with and without depression', 'patients with heart failure']","['face-to-face education, followed by either 2 phone calls (LITE) or biweekly calls until they demonstrated content competency (PLUS', 'usual care (UC', 'educational intervention']","['HF knowledge', 'HF knowledge and self-care', 'health-related quality of life (HRQOL', 'heart failure knowledge, self-care behaviors, and health-related quality of life', 'self-care']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]","[{'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0585332', 'cui_str': 'Biweekly (qualifier value)'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0036592', 'cui_str': 'Self Care'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0474417', 'cui_str': 'Self-care behavior (finding)'}]",614.0,0.0257365,"Both intervention groups showed improvement in HF knowledge at 3 months (LITE-UC, p = 0.003; PLUS-UC, p < 0.001).","[{'ForeName': 'Boyoung', 'Initials': 'B', 'LastName': 'Hwang', 'Affiliation': 'College of Nursing & Research Institute of Nursing Science, Seoul National University, Seoul, Republic of Korea. Electronic address: bhwang@snu.ac.kr.'}, {'ForeName': 'Michele M', 'Initials': 'MM', 'LastName': 'Pelter', 'Affiliation': 'School of Nursing, University of California, San Francisco, USA.'}, {'ForeName': 'Debra K', 'Initials': 'DK', 'LastName': 'Moser', 'Affiliation': 'College of Nursing, University of Kentucky, Lexington, USA.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Dracup', 'Affiliation': 'School of Nursing, University of California, San Francisco, USA.'}]",Patient education and counseling,['10.1016/j.pec.2020.01.007']
620,32122284,Racial exclusion causes acute cortisol release among emerging-adult African Americans: The role of reduced perceived control.,"Racial discrimination contributes to stress-related health disparities among African Americans, but less is known about the acute effects of racial exclusion on the hypo-pituitary-adrenocortical response and psychological mediators. Participants were 276 Black/African American emerging-adults (54% female;  M   age  = 21.74,  SD  = 2.21) who were randomly assigned to be excluded or included by White peers via the game Cyberball. Racial exclusion (vs. inclusion) predicted: greater negative affect ( F (1, 276) = 104.885,  p  < .0001), lower perceived control ( F (1, 276) = 205.523,  p  < .0001), and greater cortisol release ( F (1, 274) = 4.575,  p  = .033). Racial exclusion's impact on cortisol release was mediated by lower perceived control (95% CI: .027, .112), but not negative affect (-.041, .013). These findings suggest that racial exclusion contributes to acute cortisol release, and that reduced perceived control is a consequence of racial discrimination that has important implications for the health of those who experience discrimination.",2020,"Racial exclusion (vs. inclusion) predicted: greater negative affect ( F (1, 276) = 104.885,  ","['African Americans', 'adult African Americans', 'Participants were 276 Black/African American emerging-adults (54% female;  M age \xa0=\xa021.74,  SD \xa0=\xa02.21) who were randomly assigned to be excluded or included by White peers via the game Cyberball']",[],"['greater cortisol release', 'cortisol release']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517630', 'cui_str': '2.21'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}]",[],"[{'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}]",276.0,0.0475374,"Racial exclusion (vs. inclusion) predicted: greater negative affect ( F (1, 276) = 104.885,  ","[{'ForeName': 'Laurel M', 'Initials': 'LM', 'LastName': 'Peterson', 'Affiliation': 'Department of Psychology, Bryn Mawr College.'}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Stock', 'Affiliation': 'Department of Psychological and Brain Sciences, The George Washington University.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Monroe', 'Affiliation': 'Department of Psychology, Bryn Mawr College.'}, {'ForeName': 'Brianne K', 'Initials': 'BK', 'LastName': 'Molloy-Paolillo', 'Affiliation': 'Department of Psychological and Brain Sciences, The George Washington University.'}, {'ForeName': 'Sharon F', 'Initials': 'SF', 'LastName': 'Lambert', 'Affiliation': 'Department of Psychological and Brain Sciences, The George Washington University.'}]",The Journal of social psychology,['10.1080/00224545.2020.1729685']
621,31975494,Biventricular pacemaker therapy improves exercise capacity in patients with non-obstructive hypertrophic cardiomyopathy via augmented diastolic filling on exercise.,"AIMS


Treatment options for patients with non-obstructive hypertrophic cardiomyopathy (HCM) are limited. We sought to determine whether biventricular (BiV) pacing improves exercise capacity in HCM patients, and whether this is via augmented diastolic filling.
METHODS AND RESULTS


Thirty-one patients with symptomatic non-obstructive HCM were enrolled. Following device implantation, patients underwent detailed assessment of exercise diastolic filling using radionuclide ventriculography in BiV and sham pacing modes. Patients then entered an 8-month crossover study of BiV and sham pacing in random order, to assess the effect on exercise capacity [peak oxygen consumption (VO 2  )]. Patients were grouped on pre-specified analysis according to whether left ventricular end-diastolic volume increased (+LVEDV) or was unchanged/decreased (-LVEDV) with exercise at baseline. Twenty-nine patients (20 male, mean age 55 years) completed the study. There were 14 +LVEDV patients and 15 -LVEDV patients. Baseline peak VO 2  was lower in -LVEDV patients vs. +LVEDV patients (16.2 ± 0.9 vs. 19.9 ± 1.1 mL/kg/min, P = 0.04). BiV pacing significantly increased exercise ΔLVEDV (P = 0.004) and Δstroke volume (P = 0.008) in -LVEDV patients, but not in +LVEDV patients. Left ventricular ejection fraction and end-systolic elastance did not increase with BiV pacing in either group. This translated into significantly greater improvements in exercise capacity (peak VO 2   + 1.4 mL/kg/min, P = 0.03) and quality of life scores (P = 0.02) in -LVEDV patients during the crossover study. There was no effect on left ventricular mechanical dyssynchrony in either group.
CONCLUSION


Symptomatic patients with non-obstructive HCM may benefit from BiV pacing via augmentation of diastolic filling on exercise rather than contractile improvement. This may be due to relief of diastolic ventricular interaction.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov NCT00504647.",2020,"BiV pacing significantly increased exercise ΔLVEDV (P = 0.004) and Δstroke volume (P = 0.008) in -LVEDV patients, but not in +LVEDV patients.","['patients with non-obstructive hypertrophic cardiomyopathy via augmented diastolic filling on exercise', 'patients with non-obstructive hypertrophic cardiomyopathy (HCM', 'Symptomatic patients with non-obstructive HCM', 'HCM patients', 'Thirty-one patients with symptomatic non-obstructive HCM were enrolled', 'Twenty-nine patients (20 male, mean age 55\u2009years) completed the study']","['biventricular (BiV) pacing', 'Biventricular pacemaker therapy', 'exercise diastolic filling using radionuclide ventriculography in BiV and sham pacing modes', 'BiV and sham pacing']","['Left ventricular ejection fraction and end-systolic elastance', 'Baseline peak VO 2', 'exercise capacity [peak oxygen consumption (VO 2  ', 'exercise capacity', 'BiV pacing', 'left ventricular mechanical dyssynchrony', 'Δstroke volume', 'quality of life scores', 'left ventricular end-diastolic volume increased (+LVEDV', 'exercise ΔLVEDV']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205304', 'cui_str': 'Non-obstructive (qualifier value)'}, {'cui': 'C0007194', 'cui_str': 'Hypertrophic Cardiomyopathy'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0450355', 'cui_str': '31 (qualifier value)'}, {'cui': 'C0450351', 'cui_str': '29 (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C2936372', 'cui_str': 'Atrio-Biventricular Pacing'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0034610', 'cui_str': 'Radionuclide Ventriculography'}, {'cui': 'C0079031', 'cui_str': 'BIV'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0562458', 'cui_str': 'Pacing up and down (finding)'}]","[{'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}, {'cui': 'C0079031', 'cui_str': 'BIV'}, {'cui': 'C0562458', 'cui_str': 'Pacing up and down (finding)'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0042509', 'cui_str': 'Ventricular End-Diastolic Volume'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",31.0,0.0860411,"BiV pacing significantly increased exercise ΔLVEDV (P = 0.004) and Δstroke volume (P = 0.008) in -LVEDV patients, but not in +LVEDV patients.","[{'ForeName': 'Ibrar', 'Initials': 'I', 'LastName': 'Ahmed', 'Affiliation': 'Department of Cardiovascular Medicine, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Brodie L', 'Initials': 'BL', 'LastName': 'Loudon', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Khalid', 'Initials': 'K', 'LastName': 'Abozguia', 'Affiliation': 'Department of Cardiovascular Medicine, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Donnie', 'Initials': 'D', 'LastName': 'Cameron', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Ganesh N', 'Initials': 'GN', 'LastName': 'Shivu', 'Affiliation': 'Department of Cardiovascular Medicine, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Thanh T', 'Initials': 'TT', 'LastName': 'Phan', 'Affiliation': 'Department of Cardiovascular Medicine, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Abdul', 'Initials': 'A', 'LastName': 'Maher', 'Affiliation': 'Department of Cardiovascular Medicine, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Berthold', 'Initials': 'B', 'LastName': 'Stegemann', 'Affiliation': 'Bakken Research Centre, Medtronic Inc., Maastricht, The Netherlands.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Chow', 'Affiliation': 'Department of Cardiovascular Medicine, Royal Berkshire NHS Foundation Trust, Reading, UK.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Marshall', 'Affiliation': 'Queen Elizabeth Hospital Birmingham, Welcome Trust Clinical Research Facility, Birmingham, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Nightingale', 'Affiliation': 'Queen Elizabeth Hospital Birmingham, Welcome Trust Clinical Research Facility, Birmingham, UK.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Leyva', 'Affiliation': 'Department of Cardiovascular Medicine, Queen Elizabeth Hospital, Birmingham, UK.'}, {'ForeName': 'Vassilios S', 'Initials': 'VS', 'LastName': 'Vassiliou', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, UK.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'McKenna', 'Affiliation': 'Institute of Cardiovascular Science, University College of London, London, UK.'}, {'ForeName': 'Perry', 'Initials': 'P', 'LastName': 'Elliott', 'Affiliation': 'Institute of Cardiovascular Science, University College of London, London, UK.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Frenneaux', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, UK.'}]",European journal of heart failure,['10.1002/ejhf.1722']
622,31941553,Preliminary evaluation of the VIsion PERformance (VIPER) simulator.,"BACKGROUND


This study evaluated the VIsion PERformance (VIPER) simulator's ability to assess the functional visual performance in warfighters conducting civilian and military tasks.
METHODS


Thirty service members, aged 25-35 years old with a best corrected distance visual acuity (VA) better than or equal to 20/20 or logarithm of the minimum angle of resolution (logMAR) 0.00, were randomized to locate and identify road signs and mock improvised explosive devices (IEDs) under either daytime conditions or with infrared imagery, with (cc) and without (sc) wearing their habitual correction. Participants also underwent binocular uncorrected (UDVA) and corrected (CDVA) visual assessment, refraction, contrast sensitivity testing and wavefront aberrometry.
RESULTS


The mean age was 28.47 years. The manifest spherical equivalent was - 3.16 ± 1.75 diopters (D), the UDVA in both eyes (OU) was logMAR 0.83 ± 0.47, and the CDVA OU was - 0.11 ± 0.06. For VIPER, the mean difference in the detection distance (DD) for road signs ccDD vs. scDD was 76.7 ± 52.8 m (P < 0.001). The average difference in identification distance (ID) ccID vs. scID was 13.9 ± 6.3 m (P < 0.001). The mean accuracies were 83.5 and 27.9% for cc and sc, respectively (P < 0.001). The regression analysis indicated that a 1.6 m change in the distance accounts for a 1% change in the accuracy (P = 0.002). Without correction, a 4.1 m change accounts for a 1% change in the accuracy (P < 0.001). The average IED ccDD was 29.9 ± 8.2 m, and that for scDD was 13.2 ± 13.6 m (P < 0.001). The average IED ccID was 32.2 ± 6.2 m and that for the scID was 7.4 ± 10.3 m (P < 0.001). The mean IED identification accuracy was 46.7 and 11.4% for cc and sc, respectively (P < 0.001).
CONCLUSIONS


The preliminary results reflect VIPER's ability to assess functional visual performance when detecting and identifying signs and IEDs. Furthermore, VIPER is able to detect performance changes with and without correction.",2020,"The mean accuracies were 83.5 and 27.9% for cc and sc, respectively (P < 0.001).","['Thirty service members, aged 25-35\u2009years old with a best corrected distance visual acuity (VA) better than or equal to 20/20 or logarithm of the minimum angle of resolution (logMAR) 0.00']","['mock improvised explosive devices (IEDs) under either daytime conditions or with infrared imagery, with (cc) and without (sc) wearing their habitual correction', 'VIsion PERformance (VIPER) simulator']","['detection distance (DD) for road signs ccDD vs. scDD', 'average IED ccDD', 'identification distance', 'mean accuracies', 'functional visual performance', 'mean IED identification accuracy', 'binocular uncorrected (UDVA) and corrected (CDVA) visual assessment, refraction, contrast sensitivity testing and wavefront aberrometry', 'average IED ccID']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity (observable entity)'}, {'cui': 'C0332272', 'cui_str': 'Better (qualifier value)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}]","[{'cui': 'C0562577', 'cui_str': 'Mocking (finding)'}, {'cui': 'C0015330', 'cui_str': 'Explosive material'}, {'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0150627', 'cui_str': 'Imagery'}, {'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C0183309', 'cui_str': 'Simulator (physical object)'}]","[{'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0442650', 'cui_str': 'Road (environment)'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0020792', 'cui_str': 'Identification'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C2594855', 'cui_str': 'Binoculars'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0430943', 'cui_str': 'Refraction'}, {'cui': 'C0009928', 'cui_str': 'Visual Contrast Sensitivity'}, {'cui': 'C1532953', 'cui_str': 'Wave-front analysis'}]",,0.0702417,"The mean accuracies were 83.5 and 27.9% for cc and sc, respectively (P < 0.001).","[{'ForeName': 'Denise S', 'Initials': 'DS', 'LastName': 'Ryan', 'Affiliation': 'Warfighter Refractive Eye Surgery Program and Research Center, Fort Belvoir Community Hospital, Fort Belvoir, VA, 22060, USA. denise.s.ryan.ctr@mail.mil.'}, {'ForeName': 'Rose K', 'Initials': 'RK', 'LastName': 'Sia', 'Affiliation': 'Warfighter Refractive Eye Surgery Program and Research Center, Fort Belvoir Community Hospital, Fort Belvoir, VA, 22060, USA.'}, {'ForeName': 'Jennifer B', 'Initials': 'JB', 'LastName': 'Eaddy', 'Affiliation': 'Warfighter Refractive Eye Surgery Program and Research Center, Fort Belvoir Community Hospital, Fort Belvoir, VA, 22060, USA.'}, {'ForeName': 'Lorie A', 'Initials': 'LA', 'LastName': 'Logan', 'Affiliation': 'Warfighter Refractive Eye Surgery Program and Research Center, Fort Belvoir Community Hospital, Fort Belvoir, VA, 22060, USA.'}, {'ForeName': 'Jide O', 'Initials': 'JO', 'LastName': 'Familoni', 'Affiliation': 'Night Vision and Electronic Sensors Directorate, Fort Belvoir, VA, 22060, USA.'}, {'ForeName': 'Hind', 'Initials': 'H', 'LastName': 'Beydoun', 'Affiliation': 'Department of Research Programs, Fort Belvoir Community Hospital, Fort Belvoir, VA, 22060, USA.'}, {'ForeName': 'Samantha B', 'Initials': 'SB', 'LastName': 'Rodgers', 'Affiliation': 'Warfighter Refractive Eye Surgery Program and Research Center, Fort Belvoir Community Hospital, Fort Belvoir, VA, 22060, USA.'}, {'ForeName': 'Bruce A', 'Initials': 'BA', 'LastName': 'Rivers', 'Affiliation': 'Warfighter Refractive Eye Surgery Program and Research Center, Fort Belvoir Community Hospital, Fort Belvoir, VA, 22060, USA.'}]",Military Medical Research,['10.1186/s40779-020-0231-8']
623,31980214,Comparison between a nurse-led weaning protocol and a weaning protocol based on physician's clinical judgment in ICU patients.,"PURPOSE


The purpose of this study was to compare a nurse-led weaning protocol with a physician-driven weaning protocol in mechanically ventilated (MV) patients.
METHODS


In this quasi-experimental study with a one-group design, a total of 65 ICU patients, requiring MV for more than 72 h, were selected via convenience sampling. In routine practice, the physician's clinical judgment is needed to determine the patient's readiness for liberation from MV. A physician-driven weaning protocol was compared with a nurse-led protocol, using Burn's Weaning Scale (BWS) in three working phases. Descriptive and inferential statistics were measured for data analysis using SPSS version 16.
RESULTS


Based on BWS, the mean MV duration was 111.75±33.46 h in the nurse-led weaning group and 125.12±43.43 h in the physician-driven weaning group. There was a significant difference in terms of MV duration between the two groups (P = 0.000).
CONCLUSION


The present findings showed that nurses' assessment of patient's readiness for weaning from MV (BWS) is a safe approach during the day, which can reduce MV duration more than other typical methods in ICUs.",2020,h in the nurse-led weaning group and 125.12±43.43 h in the physician-driven weaning group.,"['65 ICU patients, requiring MV for more than 72\xa0h, were selected via convenience sampling', 'ICU patients', 'mechanically ventilated (MV) patients']",['nurse-led weaning protocol with a physician-driven weaning protocol'],"['MV duration', 'mean MV duration']","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0043084', 'cui_str': 'Weaning'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}]","[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",65.0,0.0500678,h in the nurse-led weaning group and 125.12±43.43 h in the physician-driven weaning group.,"[{'ForeName': 'Atefeh', 'Initials': 'A', 'LastName': 'Ghanbari', 'Affiliation': 'Social Determinants of Health Research Center, School of Nursing and Midwifery, Guilan University of Medical Science, Rasht, Iran. Electronic address: at_ghanbari@gums.ac.ir.'}, {'ForeName': 'Aida', 'Initials': 'A', 'LastName': 'Mohammad Ebrahimzadeh', 'Affiliation': 'The Heart Hospital of Doctor Heshmat, Guilan University of Medical Science, Rasht, Iran. Electronic address: Aidame64@gmail.com.'}, {'ForeName': 'Ezzat', 'Initials': 'E', 'LastName': 'Paryad', 'Affiliation': 'Social Determinants of Health Research Center(SDHRC), School of Nursing and Midwifery, Guilan University of Medical Science, Rasht, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Atrkar Roshan', 'Affiliation': 'Bio-Statistics, School of Medicine, Guilan University of Medical Science, Rasht, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Kazem Mohammadi', 'Affiliation': 'Guilan Province the Social Security Organization, Rasoul Akram Hospital, Rasht, Iran.'}, {'ForeName': 'Nasrin', 'Initials': 'N', 'LastName': 'Mokhtari Lakeh', 'Affiliation': 'School of Nursing and Midwifery, Guilan University of Medical Science, Rasht, Iran.'}]",Heart & lung : the journal of critical care,['10.1016/j.hrtlng.2020.01.003']
624,31974770,Psychological intervention in patients with advanced cancer at home through Individual Meaning-Centered Psychotherapy-Palliative Care: a pilot study.,"OBJECTIVE


To compare Individual Meaning-Centered Psychotherapy-Palliative Care (IMCP-PC) to counselling-based psychotherapy in patients receiving home palliative care (PC).
METHODS


Fifty-one patients with advanced-stage cancer receiving home PC were recruited for this. Two-arm (individual meaning-centered psychotherapy-palliative-IMCP-PC-care vs. counselling) randomized feasibility trial. Anxiety, depression, demoralization, and emotional distress were evaluated before and after three psychotherapy sessions. Patient perceptions of the treatment were assessed after completion of therapy.
RESULTS


Thirty-two patients (16 in each group) completed all three sessions as well as the pre- and post-therapy questionnaires and were therefore included in the final analysis. All patients in the IMCP-PC group showed a significant decrease in levels of demoralization (despair), anxiety, depression, and emotional distress. By contrast, the only variable that significantly improved in the counselling group was demoralization. The post-treatment questionnaire revealed no significant between-group differences regarding patient perception of the structure, focus, or length of treatment. However, the IMCP-PC group rated the treatment more highly with regard to its value in helping them to find meaning in life.
CONCLUSIONS


IMCP-PC is a specific psychotherapy tailored to the needs of patients with advanced cancer. The results of the present study indicate that this treatment is suitable for patients at end of life that are not able to attend outpatient sessions. Although more research is needed, the findings of this feasibility trial suggest that the IMCP-PC merits consideration for patients receiving home palliative care (PC).",2020,"All patients in the IMCP-PC group showed a significant decrease in levels of demoralization (despair), anxiety, depression, and emotional distress.","['patients with advanced cancer', 'Fifty-one patients with advanced-stage cancer receiving home PC were recruited for this', 'patients with advanced cancer at home through Individual Meaning-Centered Psychotherapy-Palliative Care', 'patients receiving home palliative care (PC']","['Psychological intervention', 'Individual Meaning-Centered Psychotherapy-Palliative Care (IMCP-PC) to counselling-based psychotherapy', 'IMCP-PC']","['patient perception of the structure, focus, or length of treatment', 'Anxiety, depression, demoralization, and emotional distress', 'levels of demoralization (despair), anxiety, depression, and emotional distress']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1273567', 'cui_str': 'Psychotherapy (specialty)'}, {'cui': 'C0700049', 'cui_str': 'Palliative care'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1273567', 'cui_str': 'Psychotherapy (specialty)'}, {'cui': 'C0700049', 'cui_str': 'Palliative care'}, {'cui': 'C0341618', 'cui_str': 'Counsel (occupation)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0233498', 'cui_str': 'Demoralization (finding)'}, {'cui': 'C0700361', 'cui_str': 'Emotional distress'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",51.0,0.0323008,"All patients in the IMCP-PC group showed a significant decrease in levels of demoralization (despair), anxiety, depression, and emotional distress.","[{'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Fraguell-Hernando', 'Affiliation': 'EAPS Mutuam Barcelona, Barcelona, Spain.'}, {'ForeName': 'Joaquín T', 'Initials': 'JT', 'LastName': 'Limonero', 'Affiliation': 'Stress and Health Research Group, Faculty of Psychology, Universitat Autònoma de Barcelona, 08193, Bellaterra (Cerdanyola del Vallès), Barcelona, Spain. joaquin.limonero@uab.cat.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Gil', 'Affiliation': 'Stress and Health Research Group, Faculty of Psychology, Universitat Autònoma de Barcelona, 08193, Bellaterra (Cerdanyola del Vallès), Barcelona, Spain.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-020-05322-2']
625,31977668,A Biomechanical Study of Tuberosity-Based Locked Plate Fixation Compared with Standard Proximal Humeral Locking Plate Fixation for 3-Part Proximal Humeral Fractures.,"BACKGROUND


One of the main shortcomings of current proximal humeral plate designs is their inability to reliably secure the greater tuberosity (GT) or lesser tuberosity, leading to fixation failure, nonunion, and rotator cuff dysfunction. Traditional proximal humeral locking plates (PHLPs) rely on isolated screw fixation or suture repair to maintain reduction of the greater and/or lesser tuberosities. This study evaluates a tuberosity-based plate (TBP) specifically designed to improve tuberosity fixation, which may decrease tuberosity displacement and related clinical sequelae.
METHODS


Five cadaveric specimens (10 shoulders) were randomized to receive either standard PHLP or TBP fixation. The specimens were skeletonized except for the rotator cuff insertion on the GT. A reproducible 3-part osteotomy was performed for each cadaver, creating head, shaft, and GT segments. Anatomic reduction and plate fixation were performed according to the surgical technique guide for each plate system, with an equal number of screws placed in each plate both proximally and distally. GT fixation was enhanced with standardized suture augmentation through the rotator cuff in every specimen in both groups. In each trial, fracture displacement, load to failure, number of cycles endured, and mechanism of failure were noted.
RESULTS


The mean load to tuberosity fixation failure for the PHLP and TBP groups was 220 and 502 N (P = 0.005), respectively.
CONCLUSIONS


The TBP had a significantly higher load to failure and significantly lower mean fracture displacement compared with the PHLP.",2020,"The mean load to tuberosity fixation failure for the PHLP and TBP groups was 220N and 502N (p=0.005), respectively.
","['Five cadaveric specimens (ten shoulders', 'Three Part Proximal Humeral Fractures']","['standardized suture augmentation', 'standard proximal humeral locking plate (PHLP) or tuberosity-based plate fixation (TBP', 'Traditional proximal humeral locking plates', 'Tuberosity-Based Locked Plate Fixation Compared to Standard Proximal Humeral Locking Plate Fixation']","['fracture displacement, load to failure, number of cycles endured, and mechanism of failure', 'mean fracture displacement', 'mean load to tuberosity fixation failure', 'GT fixation', 'Anatomic reduction and plate fixation']","[{'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0037006', 'cui_str': 'Humeral Fractures, Proximal'}]","[{'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C1293122', 'cui_str': 'Augmentation procedure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0407295', 'cui_str': 'Fixation of fracture using plate (procedure)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0077021', 'cui_str': 'tributyl phosphate'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}]","[{'cui': 'C0585059', 'cui_str': 'Fracture with displacement'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0441712', 'cui_str': 'Mechanisms (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0220784', 'cui_str': 'Anatomic (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0407295', 'cui_str': 'Fixation of fracture using plate (procedure)'}]",,0.0175279,"The mean load to tuberosity fixation failure for the PHLP and TBP groups was 220N and 502N (p=0.005), respectively.
","[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Walker', 'Affiliation': 'Department of Orthopaedic Surgery, University of Arizona College of Medicine-Phoenix, Phoenix, AZ.'}, {'ForeName': 'Paulo', 'Initials': 'P', 'LastName': 'Castaneda', 'Affiliation': 'Department of Orthopaedic Surgery, University of Arizona College of Medicine-Phoenix, Phoenix, AZ.'}, {'ForeName': 'Jill G', 'Initials': 'JG', 'LastName': 'Putnam', 'Affiliation': 'Department of Orthopaedic Surgery, University of Arizona College of Medicine-Phoenix, Phoenix, AZ.'}, {'ForeName': 'Emil H', 'Initials': 'EH', 'LastName': 'Schemitsch', 'Affiliation': 'Department of Surgery, Western University, London, ON, Canada.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'McKee', 'Affiliation': 'Department of Orthopaedic Surgery, University of Arizona College of Medicine-Phoenix, Phoenix, AZ.'}]",Journal of orthopaedic trauma,['10.1097/BOT.0000000000001744']
626,31972236,"Antibiotic Prophylaxis Is Not Required for Endoscopic Ultrasonography-Guided Fine-Needle Aspiration of Pancreatic Cystic Lesions, Based on a Randomized Trial.","BACKGROUND & AIMS


Guidelines recommend routine antibiotic prophylaxis for patients undergoing endoscopic ultrasonography-guided fine needle aspiration (EUS-FNA) of pancreatic cysts, but there is conflicting evidence for its necessity. We investigated whether performing the procedure without antimicrobial prophylaxis increases the incidence of infection.
METHODS


We performed a multicenter, randomized, noninferiority trial to compare prophylaxis with ciprofloxacin vs placebo in patients with a pancreatic cyst requiring EUS-FNA at multiple centers in Spain. From September 2014 to June 2018, patients were randomly assigned to groups that received the prophylaxis with ciprofloxacin (n = 112) or saline solution (n = 114, placebo). We recorded patients' demographic data, lesion characteristics, and procedure data and followed patients for 21 days. A total of 205 patients completed the trial (90.7%), receiving ciprofloxacin or the control, with no statistically significant differences in demographics, baseline data, or procedure characteristics between groups. The primary outcome was FNA-related infection. Secondary outcomes were incidence of fever, procedure complications, and medication-related adverse events.
RESULTS


The only case of FNA-related infection (0.44%) occurred in a patient in the placebo group (0.87%); this patient developed acute pancreatitis and bacteremia after the procedure. Prevention of infection was not inferior in the control group; the difference between proportions was 0.87% (95% confidence interval, -0.84% to 2.59%). There were no differences between groups in fever (2 patients in each group: 1.78% vs 1.76%; P = 1.00) or other adverse events.
CONCLUSIONS


In a randomized trial of patients undergoing EUS-FNA for pancreatic cyst evaluation, we found the risk of infection to be low. The incidence of infections did not differ significantly with vs without ciprofloxacin prophylaxis. (ClinicalTrials.gov, Number: NCT02261896).",2020,"Prevention of infection was not inferior in the control group; the difference between groups was 0.87% (95% CI, -0.84% to 2.59%).","['patients with a pancreatic cyst requiring EUS-FNA at multiple centers in Spain', 'patients undergoing EUS-FNA for pancreatic cyst evaluation', 'From September 2014 to June 2018, patients', 'patients undergoing endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) of pancreatic cysts']","['prophylaxis with ciprofloxacin (n=112) or saline solution (n=114, placebo', 'placebo', 'ciprofloxacin vs placebo', 'ciprofloxacin']","['incidence of infection', 'FNA-related infection', 'incidence of infections', 'fever', 'incidence of fever, procedure complications, and medication-related adverse events', 'acute pancreatitis and bacteremia', 'Prevention of infection']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030283', 'cui_str': 'Pancreatic Cyst'}, {'cui': 'C1880510', 'cui_str': 'EUS-FNA'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C0008809', 'cui_str': 'Ciprofloxacin'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0001339', 'cui_str': 'Acute pancreatitis (disorder)'}, {'cui': 'C0004610', 'cui_str': 'Bacteremia'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}]",,0.578291,"Prevention of infection was not inferior in the control group; the difference between groups was 0.87% (95% CI, -0.84% to 2.59%).","[{'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Colán-Hernández', 'Affiliation': 'Department of Gastroenterology, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Spain.'}, {'ForeName': 'Oriol', 'Initials': 'O', 'LastName': 'Sendino', 'Affiliation': ""Hospital Clínic, Universitat de Barcelona, Spain; Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, CIBERehd Spain; Institut d'Investigació Biomèdica August Pi i Sunyer, Barcelona.""}, {'ForeName': 'Carme', 'Initials': 'C', 'LastName': 'Loras', 'Affiliation': 'Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, CIBERehd Spain; Department of Gastroenterology, Hospital Universitari Mútua Terrassa, Fundació per la Recerca Mútua Terrassa, Terrassa, Spain.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Pardo', 'Affiliation': 'Hospital Joan XXIII de Tarragona, Spain.'}, {'ForeName': 'Joan B', 'Initials': 'JB', 'LastName': 'Gornals', 'Affiliation': ""Hospital de Bellvitge-Institut d'Investigació Biomèdica de Bellvitge, Barcelona, Barcelona, Spain.""}, {'ForeName': 'Mar', 'Initials': 'M', 'LastName': 'Concepción', 'Affiliation': 'Department of Gastroenterology, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Sánchez-Montes', 'Affiliation': 'Hospital Clínic, Universitat de Barcelona, Spain.'}, {'ForeName': 'Marianette', 'Initials': 'M', 'LastName': 'Murzi', 'Affiliation': 'Department of Gastroenterology, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Spain.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Andujar', 'Affiliation': 'Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, CIBERehd Spain; Department of Gastroenterology, Hospital Universitari Mútua Terrassa, Fundació per la Recerca Mútua Terrassa, Terrassa, Spain.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Velasquez-Rodriguez', 'Affiliation': ""Hospital de Bellvitge-Institut d'Investigació Biomèdica de Bellvitge, Barcelona, Barcelona, Spain.""}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Rodriguez de Miguel', 'Affiliation': 'Hospital Clínic, Universitat de Barcelona, Spain.'}, {'ForeName': 'Gloria', 'Initials': 'G', 'LastName': 'Fernández-Esparrach', 'Affiliation': ""Hospital Clínic, Universitat de Barcelona, Spain; Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, CIBERehd Spain; Institut d'Investigació Biomèdica August Pi i Sunyer, Barcelona.""}, {'ForeName': 'Angels', 'Initials': 'A', 'LastName': 'Ginés', 'Affiliation': ""Hospital Clínic, Universitat de Barcelona, Spain; Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, CIBERehd Spain; Institut d'Investigació Biomèdica August Pi i Sunyer, Barcelona.""}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Guarner-Argente', 'Affiliation': 'Department of Gastroenterology, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Spain. Electronic address: cguarnera@santpau.cat.'}]",Gastroenterology,['10.1053/j.gastro.2020.01.025']
627,31578015,Pharmacokinetic Comparison of Subcutaneous and Intravenous Nadroparin Administration for Thromboprophylaxis in Critically Ill Patients on Vasopressors.,"INTRODUCTION


Critically ill patients are exposed to a high risk of developing thromboembolism. Moreover, standard prophylaxis with subcutaneous (SC) heparin is less efficient in patients requiring vasopressors. The aim is a comparison of pharmacokinetics between SC and intravenous (IV) applied nadroparin.
METHODS


Thirty-eight ventilated ICU patients requiring vasopressor support were randomized into a single dose of nadroparin 3,800 IU (0.4 mL) subcutaneously (SC group) or 1,900 IU (0.2 mL) intravenously (IV group). Anti-factor Xa activity (anti-Xa) was observed over 24 h; data are stated as median (IQR).
RESULTS


Peak anti-Xa was significantly higher in the IV group 0.42 (0.39-0.43) IU/mL than in the SC group 0.16 (0.09-0.18) IU/mL (p < 0.001). There was a trend towards higher area under the curve (AUC) of anti-Xa in the SC group 1.41 (0.41-1.80) IU/mL × h than in the IV group 1.04 (0.93-1.13) IU/mL × h (p = 0.08). In the SC group, there was a negative correlation between anti-Xa AUC and both capillary refill time Xa (r = -0.86) and norepinephrine dose (r = -0.68). In the IV group, anti-Xa decrease half-life was 1.6 (1.4-2.0) h.
CONCLUSIONS


IV administration of 1,900 IU of nadroparin led to a predictable effective peak anti-Xa. After SC administration, anti-Xa was heterogeneous and significantly influenced by peripheral perfusion.",2020,anti-Xa was significantly higher in the IV group 0.42 (0.39-0.43) IU/mL than in the SC group 0.16 (0.09-0.18) IU/mL (p < 0.001).,"['patients requiring vasopressors', 'Thirty-eight ventilated ICU patients requiring vasopressor support', 'Critically Ill Patients on Vasopressors']","['subcutaneous (SC) heparin', 'nadroparin', 'mL', 'nadroparin 3,800 IU (0.4 mL) subcutaneously (SC group) or 1,900 IU (0.2 mL', 'Subcutaneous and Intravenous Nadroparin Administration']","['Anti-factor Xa activity (anti-Xa', 'anti-Xa decrease half-life', 'Xa', 'capillary refill time', 'peripheral perfusion', 'higher area under the curve (AUC) of anti-Xa', 'anti-Xa']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0450361', 'cui_str': '38 (qualifier value)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0010340', 'cui_str': 'Critically Ill'}]","[{'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0206232', 'cui_str': 'Nadroparin'}, {'cui': 'C4517457', 'cui_str': 'Zero point four'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C0443793', 'cui_str': 'Anti factor Xa (substance)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0018517', 'cui_str': 'Halflife'}, {'cui': 'C0425716', 'cui_str': 'Capillary refill time'}, {'cui': 'C0425710', 'cui_str': 'Peripheral blood flow (observable entity)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}]",38.0,0.0611677,anti-Xa was significantly higher in the IV group 0.42 (0.39-0.43) IU/mL than in the SC group 0.16 (0.09-0.18) IU/mL (p < 0.001).,"[{'ForeName': 'Radek', 'Initials': 'R', 'LastName': 'Cihlar', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Hospital Ceske Budejovice, Ceske Budejovice, Czechia.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Sramek', 'Affiliation': 'Faculty of Medicine, Masaryk University, Brno, Czechia.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Papiez', 'Affiliation': 'Faculty of Medicine, Masaryk University, Brno, Czechia.'}, {'ForeName': 'Miroslav', 'Initials': 'M', 'LastName': 'Penka', 'Affiliation': 'Faculty of Medicine, Masaryk University, Brno, Czechia.'}, {'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Suk', 'Affiliation': 'Faculty of Medicine, Masaryk University, Brno, Czechia, pavel.suk@fnusa.cz.'}]",Pharmacology,['10.1159/000502847']
628,31982288,Effect of zonisamide on parkinsonism in patients with dementia with Lewy bodies: A phase 3 randomized clinical trial.,"INTRODUCTION


Zonisamide is approved in Japan for treating motor dysfunction in Parkinson's disease, and might also be effective for parkinsonism in patients with dementia with Lewy bodies (DLB). Our study evaluated the safety and efficacy of zonisamide for treating parkinsonism in patients with DLB.
METHODS


This multicenter, randomized, double-blind, phase 3 trial was conducted in Japan between April 2015 and November 2017. Following a 4-week run-in period, outpatients diagnosed with probable DLB who had developed parkinsonism were randomized to receive oral zonisamide (25 or 50 mg/day) or placebo for 12 weeks, followed by a 40-week open-label extension. The primary endpoint was the change in Unified Parkinson's Disease Rating Scale (UPDRS) part III total score at Week 12.
RESULTS


Of 351 patients randomized, 346 (mean age, 77.2 years; 188 males) were included in the modified intention-to-treat population. At Week 12, the group difference (least squares mean ± SEM) for changes from baseline (vs placebo) in UPDRS part III total score was -2.7 ± 0.9 (95% confidence interval [CI]: -4.4, -0.9, P = 0.005) in the zonisamide 25-mg group and -2.6 ± 0.9 (95% CI: -4.4, -0.8, P = 0.005) in the zonisamide 50-mg group. Adverse events were reported in 47.1%, 48.7%, and 54.5% of patients in the placebo and zonisamide 25- and 50-mg groups, and led to treatment discontinuation in 5.0%, 4.3%, and 9.8% of patients, respectively.
CONCLUSION


Daily administration of 25- or 50-mg zonisamide significantly improved motor function compared with placebo; both doses were safe and well tolerated in patients with DLB.",2020,"CONCLUSION


Daily administration of 25- or 50-mg zonisamide significantly improved motor function compared with placebo; both doses were safe and well tolerated in patients with DLB.","['patients with dementia with Lewy bodies (DLB', 'outpatients diagnosed with probable DLB who had developed parkinsonism', '351 patients randomized, 346', 'Japan between April 2015 and November 2017', 'patients with DLB', 'mean age, 77.2 years; 188 males) were included in the modified intention-to-treat population', 'patients with dementia with Lewy bodies']","['zonisamide', 'placebo', 'Zonisamide', 'oral zonisamide']","['safety and efficacy', 'Adverse events', 'motor function', 'safe and well tolerated', 'UPDRS part III total score', ""change in Unified Parkinson's Disease Rating Scale (UPDRS) part III total score""]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0752347', 'cui_str': 'Dementia, Lewy Body'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0242422', 'cui_str': 'Parkinsonism'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0078844', 'cui_str': 'zonisamide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0234130', 'cui_str': 'Motor function (observable entity)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0222045'}]",351.0,0.378219,"CONCLUSION


Daily administration of 25- or 50-mg zonisamide significantly improved motor function compared with placebo; both doses were safe and well tolerated in patients with DLB.","[{'ForeName': 'Miho', 'Initials': 'M', 'LastName': 'Murata', 'Affiliation': 'Neurology, National Center Hospital, National Center of Neurology and Psychiatry, 4-1-1 Ogawa-Higashi, Kodaira, Tokyo, 187-8551, Japan.'}, {'ForeName': 'Toshinari', 'Initials': 'T', 'LastName': 'Odawara', 'Affiliation': 'Health Management Center, Yokohama City University, 22-2 Seto, Kanazawa-ku, Yokohama, Kanagawa, 236-0027, Japan.'}, {'ForeName': 'Kazuko', 'Initials': 'K', 'LastName': 'Hasegawa', 'Affiliation': 'Neurology, Sagamihara National Hospital, 18-1 Sakuradai, Minami-ku, Sagamihara, Kanagawa, 252-0392, Japan.'}, {'ForeName': 'Ritsuko', 'Initials': 'R', 'LastName': 'Kajiwara', 'Affiliation': 'Sumitomo Dainippon Pharma Co., Ltd., 1-13-1 Kyobashi, Chuo-ku, Tokyo, 104-8356, Japan.'}, {'ForeName': 'Hisao', 'Initials': 'H', 'LastName': 'Takeuchi', 'Affiliation': 'Sumitomo Dainippon Pharma Co., Ltd., 1-13-1 Kyobashi, Chuo-ku, Tokyo, 104-8356, Japan.'}, {'ForeName': 'Masaaki', 'Initials': 'M', 'LastName': 'Tagawa', 'Affiliation': 'Sumitomo Dainippon Pharma Co., Ltd., 1-13-1 Kyobashi, Chuo-ku, Tokyo, 104-8356, Japan. Electronic address: masaaki-tagawa@ds-pharma.co.jp.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Kosaka', 'Affiliation': 'Shonan Inaho Clinic, 1-3-57 Shinomiya, Hiratsuka, Kanagawa, 254-0014, Japan.'}]",Parkinsonism & related disorders,['10.1016/j.parkreldis.2019.12.005']
629,31687867,Virtual Reality-Delivered Mirror Visual Feedback and Exposure Therapy for FND: A Midpoint Report of a Randomized Controlled Feasibility Study.,"OBJECTIVE


The aim was to provide preliminary feasibility, safety, and efficacy data for a personalized virtual reality-delivered mirror visual feedback (VR-MVF) and exposure therapy (VR-ET) intervention for functional neurological disorder (FND).
METHODS


Midpoint results of a single-blind, randomized controlled pilot are presented. Fourteen adults were randomly assigned to eight weekly 30-minute VR sessions-seven in the treatment arm and seven in the control arm. The treatment arm consisted of an immersive avatar-embodied VR-MVF treatment, plus optional weekly VR-ET starting at session 4 if participants had identifiable FND triggers. The control arm received equally immersive nonembodied sessions involving exploration of a virtual interactive space. Feasibility was measured by acceptability of randomization, completion rates, side effects, adverse events, and integrity of blinding procedures. Exploratory primary and secondary outcome measures were weekly symptom frequency and the Oxford Handicap Scale, respectively.
RESULTS


Two early dropouts occurred in the treatment arm, resulting in an 86% completion rate (N=12/14). No side effects or adverse events were reported. Blind assessment at study end indicated that two of the seven treatment arm and three of the seven control arm participants incorrectly guessed their assignment. Changes in mean symptom frequency and disability were reported, but data will not be statistically analyzed until study end.
CONCLUSIONS


This study is the first to report on MVF and VR for treatment of FND. Results generated thus far support feasibility and justify continuation of the study and further investigation into the efficacy of VR interventions for FND.",2020,No side effects or adverse events were reported.,"['FND', 'functional neurological disorder (FND', 'Fourteen adults']","['personalized virtual reality-delivered mirror visual feedback (VR-MVF) and exposure therapy (VR-ET) intervention', 'Virtual Reality-Delivered Mirror Visual Feedback and Exposure Therapy', 'equally immersive nonembodied sessions involving exploration of a virtual interactive space', 'immersive avatar-embodied VR-MVF treatment, plus optional weekly VR-ET starting']","['acceptability of randomization, completion rates, side effects, adverse events, and integrity of blinding procedures', 'side effects or adverse events', 'mean symptom frequency and disability', 'weekly symptom frequency and the Oxford Handicap Scale, respectively']","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0027765', 'cui_str': 'Neurologic Disorders'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0181868', 'cui_str': 'Mirror, device (physical object)'}, {'cui': 'C2936181', 'cui_str': 'Visual Feedback'}, {'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C1280903', 'cui_str': 'Exploration procedure'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205266', 'cui_str': 'Intact (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0436350', 'cui_str': 'Symptom frequency (observable entity)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0018576', 'cui_str': 'Handicapped'}, {'cui': 'C0222045'}]",14.0,0.0403796,No side effects or adverse events were reported.,"[{'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Bullock', 'Affiliation': 'The Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, Calif. (Bullock); the Department of Communication, Cornell University, Ithaca, N.Y. (Won); the Department of Communication, Stanford University, Stanford, Calif. (Bailenson); and Palo Alto University, Palo Alto, Calif. (Friedman).'}, {'ForeName': 'Andrea Stevenson', 'Initials': 'AS', 'LastName': 'Won', 'Affiliation': 'The Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, Calif. (Bullock); the Department of Communication, Cornell University, Ithaca, N.Y. (Won); the Department of Communication, Stanford University, Stanford, Calif. (Bailenson); and Palo Alto University, Palo Alto, Calif. (Friedman).'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Bailenson', 'Affiliation': 'The Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, Calif. (Bullock); the Department of Communication, Cornell University, Ithaca, N.Y. (Won); the Department of Communication, Stanford University, Stanford, Calif. (Bailenson); and Palo Alto University, Palo Alto, Calif. (Friedman).'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Friedman', 'Affiliation': 'The Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, Calif. (Bullock); the Department of Communication, Cornell University, Ithaca, N.Y. (Won); the Department of Communication, Stanford University, Stanford, Calif. (Bailenson); and Palo Alto University, Palo Alto, Calif. (Friedman).'}]",The Journal of neuropsychiatry and clinical neurosciences,['10.1176/appi.neuropsych.19030071']
630,31968063,Effect of Multimodal Prehabilitation vs Postoperative Rehabilitation on 30-Day Postoperative Complications for Frail Patients Undergoing Resection of Colorectal Cancer: A Randomized Clinical Trial.,"Importance


Research supports use of prehabilitation to optimize physical status before and after colorectal cancer resection, but its effect on postoperative complications remains unclear. Frail patients are a target for prehabilitation interventions owing to increased risk for poor postoperative outcomes.
Objective


To assess the extent to which a prehabilitation program affects 30-day postoperative complications in frail patients undergoing colorectal cancer resection compared with postoperative rehabilitation.
Design, Setting, and Participants


This single-blind, parallel-arm, superiority randomized clinical trial recruited patients undergoing colorectal cancer resection from September 7, 2015, through June 19, 2019. Patients were followed up for 4 weeks before surgery and 4 weeks after surgery at 2 university-affiliated tertiary hospitals. A total of 418 patients 65 years or older were assessed for eligibility. Of these, 298 patients were excluded (not frail [n = 290], unable to exercise [n = 3], and planned neoadjuvant treatment [n = 5]), and 120 frail patients (Fried Frailty Index,≥2) were randomized. Ten patients were excluded after randomization because they refused surgery (n = 3), died before surgery (n = 3), had no cancer (n = 1), had surgery without bowel resection (n = 1), or were switched to palliative care (n = 2). Hence, 110 patients were included in the intention-to-treat analysis (55 in the prehabilitation [Prehab] and 55 in the rehabilitation [Rehab] groups). Data were analyzed from July 25 through August 21, 2019.
Interventions


Multimodal program involving exercise, nutritional, and psychological interventions initiated before (Prehab group) or after (Rehab group) surgery. All patients were treated within a standardized enhanced recovery pathway.
Main Outcomes and Measures


The primary outcome included the Comprehensive Complications Index measured at 30 days after surgery. Secondary outcomes were 30-day overall and severe complications, primary and total length of hospital stay, 30-day emergency department visits and hospital readmissions, recovery of walking capacity, and patient-reported outcome measures.
Results


Of 110 patients randomized, mean (SD) age was 78 (7) years; 52 (47.3%) were men and 58 (52.7%) were women; 31 (28.2%) had rectal cancer; and 87 (79.1%) underwent minimally invasive surgery. There was no between-group difference in the primary outcome measure, 30-day Comprehensive Complications Index (adjusted mean difference, -3.2; 95% CI, -11.8 to 5.3; P = .45). Secondary outcome measures were also not different between groups.
Conclusions and Relevance


In frail patients undergoing colorectal cancer resection (predominantly minimally invasive) within an enhanced recovery pathway, a multimodal prehabilitation program did not affect postoperative outcomes. Alternative strategies should be considered to optimize treatment of frail patients preoperatively.
Trial Registration


ClinicalTrials.gov identifier: NCT02502760.",2020,"There was no between-group difference in the primary outcome measure, 30-day Comprehensive Complications Index (adjusted mean difference,","['Frail Patients Undergoing Resection of Colorectal Cancer', '298 patients were excluded (not frail [n\u2009=\u2009290], unable to exercise [n\u2009=\u20093], and planned neoadjuvant treatment [n\u2009=\u20095]), and 120 frail patients (Fried Frailty Index,≥2', '110 patients were included in the intention-to-treat analysis (55 in the prehabilitation [Prehab] and 55 in the rehabilitation [Rehab] groups', 'patients undergoing colorectal cancer resection from September 7, 2015, through June 19, 2019', 'frail patients undergoing colorectal cancer resection (predominantly minimally invasive', '418 patients 65 years or older were assessed for eligibility', 'Ten patients were excluded after randomization because they refused surgery (n\u2009=\u20093), died before surgery (n\u2009=\u20093), had no cancer (n\u2009=\u20091), had surgery without bowel resection (n\u2009=\u20091), or were switched to palliative care (n\u2009=\u20092', 'frail patients preoperatively', 'frail patients undergoing colorectal cancer resection compared with postoperative rehabilitation', '110 patients randomized', ' mean (SD) age was 78 (7) years; 52 (47.3%) were men and 58 (52.7%) were women; 31 (28.2%) had rectal cancer; and 87 (79.1%) underwent minimally invasive surgery', 'Frail patients']","['prehabilitation program', 'Multimodal program involving exercise, nutritional, and psychological interventions initiated before (Prehab group) or after (Rehab group) surgery', 'Multimodal Prehabilitation vs Postoperative Rehabilitation']","['30-day Comprehensive Complications Index', '30-day overall and severe complications, primary and total length of hospital stay, 30-day emergency department visits and hospital readmissions, recovery of walking capacity, and patient-reported outcome measures', '30-Day Postoperative Complications', 'Comprehensive Complications Index']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C1299582', 'cui_str': 'Unable'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant Treatment'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1546956', 'cui_str': 'Dead (finding)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0332288', 'cui_str': 'Without (attribute)'}, {'cui': 'C0741614', 'cui_str': 'Bowel resection'}, {'cui': 'C0700049', 'cui_str': 'Palliative care'}, {'cui': 'C0877071', 'cui_str': 'Postoperative rehabilitation'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0007113', 'cui_str': 'Cancer of Rectum'}, {'cui': 'C0282624', 'cui_str': 'Minimal Surgical Procedures'}]","[{'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0877071', 'cui_str': 'Postoperative rehabilitation'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0600290', 'cui_str': 'Hospital Readmissions'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C4277735', 'cui_str': 'Patient Reported Outcome Measures'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}]",110.0,0.282382,"There was no between-group difference in the primary outcome measure, 30-day Comprehensive Complications Index (adjusted mean difference,","[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Carli', 'Affiliation': 'Department of Anesthesia, Montreal General Hospital, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Bousquet-Dion', 'Affiliation': 'Department of Anesthesia, Montreal General Hospital, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Rashami', 'Initials': 'R', 'LastName': 'Awasthi', 'Affiliation': 'Department of Anesthesia, Montreal General Hospital, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Noha', 'Initials': 'N', 'LastName': 'Elsherbini', 'Affiliation': 'Currently a medical student at Montreal General Hospital, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Sender', 'Initials': 'S', 'LastName': 'Liberman', 'Affiliation': 'Department of Surgery, Montreal General Hospital, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Marylise', 'Initials': 'M', 'LastName': 'Boutros', 'Affiliation': 'Department of Surgery, Sir Mortimer B. Davis Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Stein', 'Affiliation': 'Department of Surgery, Montreal General Hospital, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Charlebois', 'Affiliation': 'Department of Surgery, Montreal General Hospital, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Ghitulescu', 'Affiliation': 'Department of Surgery, Sir Mortimer B. Davis Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Morin', 'Affiliation': 'Department of Surgery, Sir Mortimer B. Davis Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Jagoe', 'Affiliation': 'Department of Medicine, Sir Mortimer B. Davis Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Celena', 'Initials': 'C', 'LastName': 'Scheede-Bergdahl', 'Affiliation': 'Department of Anesthesia, McGill Research Centre for Physical Activity and Health, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Enrico Maria', 'Initials': 'EM', 'LastName': 'Minnella', 'Affiliation': 'Department of Anesthesia, Montreal General Hospital, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Julio F', 'Initials': 'JF', 'LastName': 'Fiore', 'Affiliation': 'Department of Surgery, Montreal General Hospital, McGill University Health Centre, Montreal, Quebec, Canada.'}]",JAMA surgery,['10.1001/jamasurg.2019.5474']
631,31437302,"DNL104, a Centrally Penetrant RIPK1 Inhibitor, Inhibits RIP1 Kinase Phosphorylation in a Randomized Phase I Ascending Dose Study in Healthy Volunteers.","Receptor-interacting serine/threonine-protein kinase 1 (RIPK1) regulates inflammation, cytokine release, and necroptotic cell death and is implicated in pathogenic cellular pathways in amyotrophic lateral sclerosis (ALS), Alzheimer's disease (AD), and multiple sclerosis. Inhibition of RIPK1 activity protects against inflammation and cell death in multiple animal models. DNL104 is a selective, brain-penetrant inhibitor of RIPK1 phosphorylation in clinical development for AD and ALS. DNL104 was tested in 68 healthy volunteers to investigate safety and tolerability, pharmacokinetic profile in plasma and cerebrospinal fluid, and pharmacodynamic effects of RIPK1 inhibition in peripheral blood mononuclear cells in a first-in-human, placebo-controlled, double-blind, randomized single-ascending dose (SAD) and multiple-ascending dose (MAD) study. DNL104 was well-tolerated in the SAD group and during the dosing period of the MAD group. However, postdose liver toxicity in 37.5% of subjects was observed in the MAD, and assessed to be drug related. We demonstrate that DNL104 leads to RIP1 kinase inhibition, and this is not associated with central nervous system (CNS) toxicities, supporting future development of CNS penetrant RIPK1 inhibitors.",2020,"However, post-dose liver toxicity in 37.5% of subjects was observed in the MAD, and assessed to be drug related.","['68 healthy volunteers', 'healthy volunteers']",['DNL104'],"['liver toxicity', 'safety and tolerability, pharmacokinetic profile in plasma and CSF, and pharmacodynamic effects of RIPK1 inhibition in PBMCs']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]",[],"[{'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}]",68.0,0.0464466,"However, post-dose liver toxicity in 37.5% of subjects was observed in the MAD, and assessed to be drug related.","[{'ForeName': 'Hendrika W', 'Initials': 'HW', 'LastName': 'Grievink', 'Affiliation': 'Centre for Human Drug Research, Leiden, The Netherlands.'}, {'ForeName': 'Jules A A C', 'Initials': 'JAAC', 'LastName': 'Heuberger', 'Affiliation': 'Centre for Human Drug Research, Leiden, The Netherlands.'}, {'ForeName': 'Fen', 'Initials': 'F', 'LastName': 'Huang', 'Affiliation': 'Denali Therapeutics, South San Francisco, California, USA.'}, {'ForeName': 'Rinkal', 'Initials': 'R', 'LastName': 'Chaudhary', 'Affiliation': 'Denali Therapeutics, South San Francisco, California, USA.'}, {'ForeName': 'Willem A J', 'Initials': 'WAJ', 'LastName': 'Birkhoff', 'Affiliation': 'Centre for Human Drug Research, Leiden, The Netherlands.'}, {'ForeName': 'George R', 'Initials': 'GR', 'LastName': 'Tonn', 'Affiliation': 'Denali Therapeutics, South San Francisco, California, USA.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Mosesova', 'Affiliation': 'Denali Therapeutics, South San Francisco, California, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Erickson', 'Affiliation': 'Denali Therapeutics, South San Francisco, California, USA.'}, {'ForeName': 'Matthijs', 'Initials': 'M', 'LastName': 'Moerland', 'Affiliation': 'Centre for Human Drug Research, Leiden, The Netherlands.'}, {'ForeName': 'Patrick C G', 'Initials': 'PCG', 'LastName': 'Haddick', 'Affiliation': 'Denali Therapeutics, South San Francisco, California, USA.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Scearce-Levie', 'Affiliation': 'Denali Therapeutics, South San Francisco, California, USA.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Ho', 'Affiliation': 'Denali Therapeutics, South San Francisco, California, USA.'}, {'ForeName': 'Geert Jan', 'Initials': 'GJ', 'LastName': 'Groeneveld', 'Affiliation': 'Centre for Human Drug Research, Leiden, The Netherlands.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.1615']
632,31603582,Auricular acupuncture for adult tonsillectomy.,"OBJECTIVES


Adult tonsillectomy causes significant postoperative pain that can last over 14 days, but narcotic regimens only provide a modest reduction in pain. Auricular acupuncture has been demonstrated to improve pain with minimal complications. This study compared acupuncture versus control for pain, opioid consumption, nausea, and return of diet and activity following tonsillectomy.
METHODS


A prospective, single-blinded randomized controlled trial was performed on 134 adults undergoing tonsillectomy at a tertiary care teaching hospital. Each patient was randomized to receive either auricular (Battlefield protocol) acupuncture with auricular bandages or bandages alone while under general anesthesia. Subjects journaled daily postoperative pain, diet, activity, and opioid consumption, then returned to the clinic on postoperative day 14 for a final questionnaire and evaluation.
RESULTS


Ninety-nine patients completed the study with 50 patients in the acupuncture group and 49 patients in the control group. Pain scores for the acupuncture group following tonsillectomy were significantly lower than the control group on the day of surgery (2.9, 4.3; P = .01), but there was no statistically significant difference in pain thereafter. There was an equivalent level of postoperative narcotic usage, nausea, emesis, functional activity and diet between the two groups. The main complication following tonsillectomy was secondary hemorrhage and there was no significant difference between the two groups (20%, 10%; P = .13).
CONCLUSION


Auricular acupuncture provides increased pain relief on the day of surgery, an effect that seems to diminish after 24 hours.
LEVEL OF EVIDENCE


1b Laryngoscope, 130: 1907-1912, 2020.",2020,"Pain scores for the acupuncture group following tonsillectomy were significantly lower than the control group on the day of surgery (2.9, 4.3; P = .01), but there was no statistically significant difference in pain thereafter.","['134 adults undergoing tonsillectomy at a tertiary care teaching hospital', 'Ninety-nine patients completed the study with 50 patients in the acupuncture group and 49 patients in the control group', 'adult tonsillectomy']","['auricular (Battlefield protocol) acupuncture with auricular bandages or bandages alone while under general anesthesia', 'Auricular acupuncture', 'acupuncture']","['Subjects journaled daily postoperative pain, diet, activity, and opioid consumption', 'pain', 'pain with minimal complications', 'pain thereafter', 'postoperative narcotic usage, nausea, emesis, functional activity and diet', 'Pain scores', 'pain relief', 'pain, opioid consumption, nausea, and return of diet and activity']","[{'cui': 'C4517565', 'cui_str': 'One hundred and thirty-four'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0040423', 'cui_str': 'Tonsillectomy'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0020027', 'cui_str': 'Teaching Hospitals'}, {'cui': 'C3828813', 'cui_str': 'Ninety-nine'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0150468', 'cui_str': 'Application of bandage (procedure)'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0752217', 'cui_str': 'Auricular Acupuncture'}]","[{'cui': 'C2316067', 'cui_str': 'Journaling (regime/therapy)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0027415', 'cui_str': 'Narcotics'}, {'cui': 'C0457083', 'cui_str': 'Usage (attribute)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}]",99.0,0.193897,"Pain scores for the acupuncture group following tonsillectomy were significantly lower than the control group on the day of surgery (2.9, 4.3; P = .01), but there was no statistically significant difference in pain thereafter.","[{'ForeName': 'Anil N', 'Initials': 'AN', 'LastName': 'Shah', 'Affiliation': 'Department of Otolaryngology, Naval Hospital Bremerton, Bremerton, Washington, U.S.A.'}, {'ForeName': 'Chad B', 'Initials': 'CB', 'LastName': 'Moore', 'Affiliation': 'Nurse Anesthesia Program, Uniformed Services University of the Health Sciences, Bethesda, Maryland, U.S.A.'}, {'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Brigger', 'Affiliation': 'Department of Otolaryngology, Naval Medical Center San Diego, San Diego, California, U.S.A.'}]",The Laryngoscope,['10.1002/lary.28338']
633,31633746,Effect of Depression Screening After Acute Coronary Syndromes on Quality of Life: The CODIACS-QoL Randomized Clinical Trial.,"Importance


Patients with acute coronary syndrome (ACS) and elevated depressive symptoms are at increased risk for recurrent cardiovascular events and mortality, worse quality of life, and higher health care costs. These observational findings prompted multiple scientific panels to advise universal depression screening in survivors of ACS prior to evidence from randomized screening trials.
Objective


To determine whether systematically screening for depression in survivors of ACS improves quality of life and depression compared with usual care.
Design, Setting, and Participants


A 3-group multisite randomized trial enrolled 1500 patients with ACS from 4 health care systems between November 1, 2013, and March 31, 2017, with follow-up ending July 31, 2018. Patients were eligible if they had been hospitalized for ACS in the previous 2 to 12 months and had no prior history of depression. All analyses were performed on an intention-to-treat basis.
Interventions


Patients with ACS were randomly assigned 1:1:1 to receive (1) systematic depression screening using the 8-item Patient Health Questionnaire, with notification of primary care clinicians and provision of centralized, patient-preference, stepped depression care for those with positive screening results (8-item Patient Health Questionnaire score ≥10; screen, notify, and treat, n = 499); (2) systematic depression screening, with notification of primary care clinicians for those with positive screening results (screen and notify, n = 501); and (3) usual care (no screening, n = 500).
Main Outcomes and Measures


The primary outcome was change in quality-adjusted life-years. The secondary outcome was depression-free days. Adverse effects and mortality were assessed by patient interview and hospital records.
Results


A total of 1500 patients (424 women and 1076 men; mean [SD] age, 65.9 [11.5] years) were randomized in the 18-month trial. Only 71 of 1000 eligible survivors of ACS (7.1%) had elevated 8-item Patient Health Questionnaire scores indicating depressive symptoms at screening. There were no differences in mean (SD) change in quality-adjusted life-years (screen, notify and treat, -0.06 [0.20]; screen and notify, -0.06 [0.20]; no screen, -0.06 [0.18]; P = .98) or cumulative mean (SD) depression-free days (screen, notify and treat, 343.1 [179.0] days; screen and notify, 351.3 [175.0] days; no screen, 339.0 [176.6] days; P = .63). Harms including death, bleeding, or sleep difficulties did not differ among groups.
Conclusions and Relevance


In patients with ACS without a history of depression, systematic depression screening with or without providing depression treatment did not alter quality-adjusted life-years, depression-free days, or harms.
Trial Registration


ClinicalTrials.gov identifier: NCT01993017.",2019,"Harms including death, bleeding, or sleep difficulties did not differ among groups.
","['primary care clinicians for those with positive screening results (screen and notify, n\u2009=\u2009501); and (3) usual care (no screening, n\u2009=\u2009500', 'Interventions\n\n\nPatients with ACS', 'Patients were eligible if they had been hospitalized for ACS in the previous 2 to 12 months and had no prior history of depression', 'Patients with acute coronary syndrome (ACS', '1500 patients (424 women and 1076 men; mean [SD] age, 65.9 [11.5] years', '1500 patients with ACS from 4 health care systems between November 1, 2013, and March 31, 2017, with follow-up ending July 31, 2018', 'patients with ACS without a history of depression, systematic depression screening with or without providing depression treatment']","['systematic depression screening using the 8-item Patient Health Questionnaire, with notification of primary care clinicians and provision of centralized, patient-preference, stepped depression care for those with positive screening results (8-item Patient Health Questionnaire score ≥10; screen, notify, and treat, n\u2009=\u2009499', 'Depression Screening']","['depression-free days', 'death, bleeding, or sleep difficulties', 'Adverse effects and mortality', 'quality-adjusted life-years, depression-free days, or harms', 'Quality of Life', 'change in quality-adjusted life-years', 'mean (SD) change in quality-adjusted life-years (screen, notify and treat', 'quality of life and depression', 'elevated 8-item Patient Health Questionnaire scores indicating depressive symptoms']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0455503', 'cui_str': 'H/O: depression'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517534', 'cui_str': '11.5 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0018696', 'cui_str': 'Health Care Systems'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0220922', 'cui_str': 'systematics'}, {'cui': 'C0740218', 'cui_str': 'Depression screening (procedure)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0220922', 'cui_str': 'systematics'}, {'cui': 'C0740218', 'cui_str': 'Depression screening (procedure)'}, {'cui': 'C1879301', 'cui_str': 'Patient Health Questionnaire'}, {'cui': 'C0422202', 'cui_str': 'Notifications (procedure)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0376409', 'cui_str': 'Patient Preference'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0034380'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C1879301', 'cui_str': 'Patient Health Questionnaire'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}]",1500.0,0.266734,"Harms including death, bleeding, or sleep difficulties did not differ among groups.
","[{'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Kronish', 'Affiliation': 'Center for Behavioral Cardiovascular Health, Department of Medicine, Columbia University Irving Medical Center, New York, New York.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Moise', 'Affiliation': 'Center for Behavioral Cardiovascular Health, Department of Medicine, Columbia University Irving Medical Center, New York, New York.'}, {'ForeName': 'Ying Kuen', 'Initials': 'YK', 'LastName': 'Cheung', 'Affiliation': 'Department of Biostatistics, Mailman School of Public Health, Columbia University Irving Medical Center, New York, New York.'}, {'ForeName': 'Gregory N', 'Initials': 'GN', 'LastName': 'Clarke', 'Affiliation': 'Center for Health Research, Kaiser Permanente, Portland, Oregon.'}, {'ForeName': 'Rowena J', 'Initials': 'RJ', 'LastName': 'Dolor', 'Affiliation': 'Department of Medicine, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Duer-Hefele', 'Affiliation': 'Center for Personalized Medicine, Northwell Health, New York, New York.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Margolis', 'Affiliation': 'HealthPartners Institute, Minneapolis, Minneapolis.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'St Onge', 'Affiliation': 'Center for Behavioral Cardiovascular Health, Department of Medicine, Columbia University Irving Medical Center, New York, New York.'}, {'ForeName': 'Faith', 'Initials': 'F', 'LastName': 'Parsons', 'Affiliation': 'Center for Behavioral Cardiovascular Health, Department of Medicine, Columbia University Irving Medical Center, New York, New York.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Retuerto', 'Affiliation': 'Center for Behavioral Cardiovascular Health, Department of Medicine, Columbia University Irving Medical Center, New York, New York.'}, {'ForeName': 'Anusorn', 'Initials': 'A', 'LastName': 'Thanataveerat', 'Affiliation': 'Center for Behavioral Cardiovascular Health, Department of Medicine, Columbia University Irving Medical Center, New York, New York.'}, {'ForeName': 'Karina W', 'Initials': 'KW', 'LastName': 'Davidson', 'Affiliation': 'Department of Medicine, Northwell Health, New York, New York.'}]",JAMA internal medicine,['10.1001/jamainternmed.2019.4518']
634,27145207,The Effect of Reduced Dietary Fat and Soy Supplementation on Circulating Adipocytokines in Postmenopausal Women: A Randomized Controlled 2-Month Trial.,"The reduced risk of breast cancer observed in Asia has been linked with diets rich in soy foods, and observational studies suggest that regular soy food intake is related to lower circulating levels of some inflammatory markers which have been implicated in breast cancer risk. However, short-term intervention studies with soy-based diets in small numbers of women have shown few significant changes in adipocytokine levels. This 8-wk dietary intervention study in 57 healthy postmenopausal women investigated whether soy food supplementation (50 mg isoflavones or 15 g soy protein in the form of tofu) or a very low-fat diet (11.3% of total energy), similar to the traditional Asian diet, is associated with beneficial effects on serum levels of the following adipocytokines: TNF-α, IL-6, adiponectin, and resistin. We found no statistically significant changes in the levels of these adipocytokines in association with the very low-fat diet or soy supplementation. Only the change in TNF-α levels between the very low-fat and control diet groups had borderline statistical significance. We conclude that ingestion of a very low-fat diet or a soy food supplemented diet for 8 wk does not significantly alter important circulating adipocytokines.",2016,We found no statistically significant changes in the levels of these adipocytokines in association with the very low-fat diet or soy supplementation.,"['57 healthy postmenopausal women', 'Postmenopausal Women']","['Reduced Dietary Fat and Soy Supplementation', 'soy food supplementation (50\xa0mg isoflavones or 15\xa0g soy protein in the form of tofu) or a very low-fat diet']","['important circulating adipocytokines', 'adipocytokine levels', 'TNF-α levels']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0012171', 'cui_str': 'Dietary Fats'}, {'cui': 'C1258091', 'cui_str': 'Soy Foods'}, {'cui': 'C0022179', 'cui_str': 'Isoflavone Derivatives'}, {'cui': 'C0074926', 'cui_str': 'Soy Proteins'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0453233', 'cui_str': 'Tofu'}, {'cui': 'C0452296', 'cui_str': 'Very low fat diet (finding)'}]","[{'cui': 'C1955907', 'cui_str': 'Adipocytokines'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}]",57.0,0.0222613,We found no statistically significant changes in the levels of these adipocytokines in association with the very low-fat diet or soy supplementation.,"[{'ForeName': 'Malini', 'Initials': 'M', 'LastName': 'Nadadur', 'Affiliation': 'a Department of Obstetrics and Gynecology , Keck School of Medicine of USC , Los Angeles , California.'}, {'ForeName': 'Frank Z', 'Initials': 'FZ', 'LastName': 'Stanczyk', 'Affiliation': 'b Departments of Obstetrics and Gynecology and Preventive Medicine , Keck School of Medicine of USC , Los Angeles , California.'}, {'ForeName': 'Chiu-Chen', 'Initials': 'CC', 'LastName': 'Tseng', 'Affiliation': 'c Department of Preventive Medicine , Keck School of Medicine of USC , Los Angeles , California.'}, {'ForeName': 'Lila', 'Initials': 'L', 'LastName': 'Kim', 'Affiliation': 'a Department of Obstetrics and Gynecology , Keck School of Medicine of USC , Los Angeles , California.'}, {'ForeName': 'Anna H', 'Initials': 'AH', 'LastName': 'Wu', 'Affiliation': 'c Department of Preventive Medicine , Keck School of Medicine of USC , Los Angeles , California.'}]",Nutrition and cancer,['10.1080/01635581.2016.1158294']
635,31925317,A randomised phase II trial of hydroxychloroquine and imatinib versus imatinib alone for patients with chronic myeloid leukaemia in major cytogenetic response with residual disease.,"In chronic-phase chronic myeloid leukaemia (CP-CML), residual BCR-ABL1+ leukaemia stem cells are responsible for disease persistence despite TKI. Based on in vitro data, CHOICES (CHlorOquine and Imatinib Combination to Eliminate Stem cells) was an international, randomised phase II trial designed to study the safety and efficacy of imatinib (IM) and hydroxychloroquine (HCQ) compared with IM alone in CP-CML patients in major cytogenetic remission with residual disease detectable by qPCR. Sixty-two patients were randomly assigned to either arm. Treatment 'successes' was the primary end point, defined as ≥0.5 log reduction in 12-month qPCR level from trial entry. Selected secondary study end points were 24-month treatment 'successes', molecular response and progression at 12 and 24 months, comparison of IM levels, and achievement of blood HCQ levels >2000 ng/ml. At 12 months, there was no difference in 'success' rate (p = 0.58); MMR was achieved in 80% (IM) vs 92% (IM/HCQ) (p = 0.21). At 24 months, the 'success' rate was 20.8% higher with IM/HCQ (p = 0.059). No patients progressed. Seventeen serious adverse events, including four serious adverse reactions, were reported; diarrhoea occurred more frequently with combination. IM/HCQ is tolerable in CP-CML, with modest improvement in qPCR levels at 12 and 24 months, suggesting autophagy inhibition maybe of clinical value in CP-CML.",2020,"At 12 months, there was no difference in 'success' rate (p = 0.58); MMR was achieved in 80% (IM) vs 92% (IM/HCQ) (p = 0.21).","['2000', 'CP-CML patients in major cytogenetic remission with residual disease detectable by qPCR', 'patients with chronic myeloid leukaemia in major cytogenetic response with residual disease', 'Sixty-two patients']","['hydroxychloroquine and imatinib versus imatinib alone', 'IM/HCQ', 'imatinib (IM) and hydroxychloroquine (HCQ']","['MMR', 'diarrhoea', ""24-month treatment 'successes', molecular response and progression at 12 and 24 months, comparison of IM levels, and achievement of blood HCQ levels"", 'qPCR levels', ""success' rate""]","[{'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0023473', 'cui_str': 'Leukemia, Granulocytic, Chronic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0010802', 'cui_str': 'Cytogenetic'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C4055168', 'cui_str': 'Cytogenetic response'}, {'cui': 'C4517835', 'cui_str': '62 (qualifier value)'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0935989', 'cui_str': 'imatinib'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}]",62.0,0.0257648,"At 12 months, there was no difference in 'success' rate (p = 0.58); MMR was achieved in 80% (IM) vs 92% (IM/HCQ) (p = 0.21).","[{'ForeName': 'G A', 'Initials': 'GA', 'LastName': 'Horne', 'Affiliation': ""Paul O'Gorman Leukaemia Research Centre, Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Stobo', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Kelly', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Mukhopadhyay', 'Affiliation': ""Paul O'Gorman Leukaemia Research Centre, Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.""}, {'ForeName': 'A L', 'Initials': 'AL', 'LastName': 'Latif', 'Affiliation': ""Paul O'Gorman Leukaemia Research Centre, Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Dixon-Hughes', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'McMahon', 'Affiliation': 'Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Cony-Makhoul', 'Affiliation': 'Haematology department, CH Annecy-Genevois, Pringy, France.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Byrne', 'Affiliation': 'Department of Haematology, Nottingham City Hospital, Nottingham, UK.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Smith', 'Affiliation': ""Department of Haematology, St James's University Hospital, Leeds, UK.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Koschmieder', 'Affiliation': 'Department of Medicine (Hematology Oncology, Hemostaseology, and Stem Cell Transplantation), Faculty of Medicine, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'T H', 'Initials': 'TH', 'LastName': 'BrÜmmendorf', 'Affiliation': 'Department of Medicine (Hematology Oncology, Hemostaseology, and Stem Cell Transplantation), Faculty of Medicine, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Schafhausen', 'Affiliation': 'Department of Internal Medicine, University Medical Center Hamburg, Hamburg, Germany.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Gallipoli', 'Affiliation': 'Centre for Haemato-Oncology, Barts Cancer Institute, Queen Mary University of London, London, UK.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Thomson', 'Affiliation': 'Experimental therapeutics, Wolfson Wohl Cancer Research Centre, Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Cong', 'Affiliation': 'Experimental therapeutics, Wolfson Wohl Cancer Research Centre, Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'R E', 'Initials': 'RE', 'LastName': 'Clark', 'Affiliation': 'Molecular and Clinical Cancer Medicine, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Milojkovic', 'Affiliation': 'Department of Haematology, Hammersmith Hospital, London, UK.'}, {'ForeName': 'G V', 'Initials': 'GV', 'LastName': 'Helgason', 'Affiliation': ""Paul O'Gorman Leukaemia Research Centre, Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.""}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Foroni', 'Affiliation': 'Department of Haematology, Imperial College London, London, UK.'}, {'ForeName': 'F E', 'Initials': 'FE', 'LastName': 'Nicolini', 'Affiliation': 'Hématologie Clinique and INSERM U1052, CRCL, Centre Léon Bérard, Lyon, France.'}, {'ForeName': 'T L', 'Initials': 'TL', 'LastName': 'Holyoake', 'Affiliation': ""Paul O'Gorman Leukaemia Research Centre, Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Copland', 'Affiliation': ""Paul O'Gorman Leukaemia Research Centre, Institute of Cancer Sciences, University of Glasgow, Glasgow, UK. Mhairi.Copland@glasgow.ac.uk.""}]",Leukemia,['10.1038/s41375-019-0700-9']
636,31390660,Acute and Long-term Memantine Add-on Treatment to Risperidone Improves Cognitive Dysfunction in Patients with Acute and Chronic Schizophrenia.,"INTRODUCTION


Patients with schizophrenia are mainly characterized by negative symptoms and cognitive dysfunction. In this proof-of-concept study we tested effects on cognition and negative symptoms of a 6- or 24-week memantine add-on treatment to risperidone in patients with acute or chronic schizophrenia.
MATERIALS AND METHODS


Patients with an acute episode of schizophrenia (n=11) and predominating positive symptoms were randomized to a 6-week add-on treatment with memantine (10 mg twice a day) versus placebo and patients with chronic schizophrenia (n=13) and negative symptoms were randomized to a 24-week add-on treatment with memantine (10 mg twice a day) versus placebo. All patients received antipsychotic medication with risperidone (2-8 mg/day). Psychopathological changes were assessed with the Positive and Negative Syndrome Scale (PANSS) at baseline and after 2, 4, 6, 12, and 24 weeks. Cognitive function was measured at baseline, after 6 weeks, and 24 weeks.
RESULTS


Patients with acute schizophrenia who received add-on treatment with memantine showed a significantly higher performance in attention intensity (p=0.043), problem-solving (p=0.043), verbal learning (p=0.050), and flexibility (p=0.049). Patients with chronic schizophrenia showed a significantly higher immediate memory in the memantine group compared to the placebo group (p=0.033) and a significantly greater reduction of the PANSS sum score if compared to the placebo group.
DISCUSSIONS


Our study gives further evidence that memantine add-on treatment to risperidone may have neuroprotective effects and improve cognitive function in patients with schizophrenia. ClinicalTrials.gov Number: NCT00148590 and NCT00148616.",2020,"Patients with chronic schizophrenia showed a significantly higher immediate memory in the memantine group compared to the placebo group (p=0.033) and a significantly greater reduction of the PANSS sum score if compared to the placebo group.
","['Patients with acute schizophrenia', 'Patients with Acute and Chronic Schizophrenia', 'Patients with chronic schizophrenia', 'patients with acute or chronic schizophrenia', 'Patients with an acute episode of schizophrenia (n=11) and predominating positive symptoms', 'and patients with chronic schizophrenia (n=13) and negative symptoms', 'patients with schizophrenia']","['risperidone', 'memantine', 'placebo', 'antipsychotic medication with risperidone', 'Memantine', 'Risperidone']","['performance in attention intensity', 'verbal learning (p=0.050), and flexibility', 'Psychopathological changes', 'PANSS sum score', 'Positive and Negative Syndrome Scale (PANSS', 'Cognitive Dysfunction', 'immediate memory', 'problem-solving', 'Cognitive function', 'cognitive function']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0857501', 'cui_str': 'Acute schizophrenia'}, {'cui': 'C0221765', 'cui_str': 'Chronic schizophrenia (disorder)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0332251', 'cui_str': 'Predominate (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}]","[{'cui': 'C0073393', 'cui_str': 'Risperidone'}, {'cui': 'C0025242', 'cui_str': 'Memantine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic Drugs'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0042531', 'cui_str': 'Verbal Learning'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale (assessment scale)'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C3669643', 'cui_str': 'Problem solving (qualifier value)'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}]",,0.161044,"Patients with chronic schizophrenia showed a significantly higher immediate memory in the memantine group compared to the placebo group (p=0.033) and a significantly greater reduction of the PANSS sum score if compared to the placebo group.
","[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Schaefer', 'Affiliation': 'Department of Psychiatry, Psychotherapy, Psychosomatics and Addiction Medicine, Kliniken Essen-Mitte, Essen, Germany.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Sarkar', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Charité-Universitätsmedizin Berlin, Campus Charité Mitte, Berlin, Germany.'}, {'ForeName': 'Ines', 'Initials': 'I', 'LastName': 'Theophil', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Charité-Universitätsmedizin Berlin, Campus Charité Mitte, Berlin, Germany.'}, {'ForeName': 'Karolina', 'Initials': 'K', 'LastName': 'Leopold', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Wenckebachklinikum, Berlin, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Heinz', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Charité-Universitätsmedizin Berlin, Campus Charité Mitte, Berlin, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Gallinat', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Charité-Universitätsmedizin Berlin, Campus Charité Mitte, Berlin, Germany.'}]",Pharmacopsychiatry,['10.1055/a-0970-9310']
637,31948337,The short-term impact of dietary fat and sugar intake on breast milk composition: A clinical trial protocol.,"BACKGROUND


Breast milk is uniquely designed for the infant and contains the key nutrients and bioactive factors required to support optimal infant health and development. While previous studies have reported that maternal obesity can influence milk composition, whether this relationship is driven by maternal or dietary factors remains unclear.
AIM


The aim of this study is to assess the impact of test meals varying in fat and sugar content on post-prandial concentrations of macronutrients and metabolic hormones in the breast milk.
METHODS


This open label crossover study will include 25 lactating women. On the three days of the intervention, women will be randomized to receive a breakfast meal with a fat and sugar content consistent with the Australian Guide to Healthy Eating (9 g fat, 25 g of sugar) or a breakfast meal containing higher levels of fat (28 g fat, 18 g of sugar) or sugar (5 g fat, 56 g of sugar). All breakfast meals will be similar in composition (cereal, milk, yogurt, toast and spread) and matched for total energy content. This study will measure breast milk concentrations of metabolic hormones (leptin, insulin, adiponectin, ghrelin and glucagon-like peptide-1) and macronutrients in the following 12 hours.
RESULTS AND CONCLUSION


The results of this study will provide novel direct evidence of the impact of variations in dietary fat and sugar content to alter the macronutrient and/or metabolic hormone concentrations in breast milk. Data on the effect of maternal diet on milk composition is critical given the established importance of nutritional exposures in early infancy for an individual's life-long health outcomes.",2020,"This study will measure breast milk concentrations of metabolic hormones (leptin, insulin, adiponectin, ghrelin and glucagon-like peptide-1) and macronutrients in the following 12 hours.
",['25 lactating women'],"['breakfast meal containing higher levels of fat (28 g fat, 18 g of sugar) or sugar ', 'breakfast meal with a fat and sugar content consistent with the Australian Guide to Healthy Eating', 'dietary fat and sugar intake']","['breast milk composition', 'metabolic hormones (leptin, insulin, adiponectin, ghrelin and glucagon-like peptide-1) and macronutrients']","[{'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C4553621', 'cui_str': 'With breakfast'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C3164740', 'cui_str': '28 gauge (qualifier value)'}, {'cui': 'C0456637', 'cui_str': '18G (qualifier value)'}, {'cui': 'C0242209', 'cui_str': 'Sugars'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0332290', 'cui_str': 'Consistent with (qualifier value)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0452415', 'cui_str': 'Healthy Diet'}, {'cui': 'C0012171', 'cui_str': 'Dietary Fats'}, {'cui': 'C0556234', 'cui_str': 'Sugar intake (observable entity)'}]","[{'cui': 'C0026140', 'cui_str': 'Breast Milk'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin (substance)'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}]",,0.0599851,"This study will measure breast milk concentrations of metabolic hormones (leptin, insulin, adiponectin, ghrelin and glucagon-like peptide-1) and macronutrients in the following 12 hours.
","[{'ForeName': 'Gabriela E', 'Initials': 'GE', 'LastName': 'Leghi', 'Affiliation': 'Department of Food and Wine Sciences, The University of Adelaide, Australia.'}, {'ForeName': 'Merryn', 'Initials': 'M', 'LastName': 'Netting', 'Affiliation': 'Healthy Mothers, Babies and Children Theme, South Australian Health and Medical Research Institute (SAHMRI), Australia.'}, {'ForeName': 'Beverly S', 'Initials': 'BS', 'LastName': 'Muhlhausler', 'Affiliation': 'Department of Food and Wine Sciences, The University of Adelaide, Australia.'}]",Nutrition and health,['10.1177/0260106019895367']
638,31866488,Randomized Controlled Trial of Advance Care Planning Video Decision Aid for the General Population.,"CONTEXT


Advance care planning (ACP) in a healthy general population could improve the quality of care when a health problem arises.
OBJECTIVES


The purpose of this study was to evaluate the efficacy of video decision support aid in increasing the intention to document ACP in the general healthy population.
METHODS


In this randomized controlled trial, we enrolled 250 members of the general population (aged 20 years and older and determined to be healthy), stratified by age and sex. The intervention was a video that provided information about ACP and end-of-life care options such as cardiopulmonary resuscitation (CPR) and palliative care. An attention-control arm was given a booklet about advance directives. Primary outcome was a change in intention to document ACP. Secondary outcomes included the intention to refuse CPR at terminal status, CPR and palliative care knowledge score, and the Hospital Anxiety and Depression Scale.
RESULTS


About 250 participants were randomly assigned, half to the video-assisted intervention group and half to the attention-control group. Within one week postintervention, the intention to document ACP was significantly higher in the video-assisted intervention arm (68.0% vs. 39.2%; P < 0.001), and changes in the intention to document ACP were significantly greater in the video group than in the brochure group (P = 0.008; Δ = 14.4%). Palliative care knowledge score was also significantly increased in the video group (P = 0.036).
CONCLUSION


A well-constructed video decision support intervention can increase the intention to document ACP in the general population that presumably had little opportunity to discuss ACP with physicians.",2020,"Within 1 week post-intervention, the intention to document ACP was significantly higher in the video-assisted intervention arm (68.0% vs 39.2%; p < 0.001) and changes in the intention to document ACP were significantly greater in the video group than in the brochure group (p = 0.008; Δ = 14.4%).","['250 participants', 'enrolled 250 members of the general population (aged ≥20 years and determined to be healthy), stratified by age and sex']","['video-assisted intervention group and half to the attention-control group', 'video decision-support aid']","['change in intention to document ACP', 'intention to refuse CPR at terminal status, CPR and palliative care knowledge score, and the Hospital Anxiety and Depression Scale (HADS', 'Palliative care knowledge score', 'intention to document ACP']","[{'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0680022', 'cui_str': 'Member of (attribute)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}]","[{'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0449435', 'cui_str': 'Aid (attribute)'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C1705116', 'cui_str': 'Refused (qualifier value)'}, {'cui': 'C0007203', 'cui_str': 'Cardio-Pulmonary Resuscitation'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0700049', 'cui_str': 'Palliative care'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C0048008', 'cui_str': 'Benzenamine, 4-((4-aminophenyl)sulfonyl)-N-hydroxy-'}]",250.0,0.115523,"Within 1 week post-intervention, the intention to document ACP was significantly higher in the video-assisted intervention arm (68.0% vs 39.2%; p < 0.001) and changes in the intention to document ACP were significantly greater in the video group than in the brochure group (p = 0.008; Δ = 14.4%).","[{'ForeName': 'EunKyo', 'Initials': 'E', 'LastName': 'Kang', 'Affiliation': 'Department of Family Medicine, Seoul National University Hospital, Jongno gu, Seoul, Korea; Institute for Public Health and Medical Service, Seoul National University Hospital, Jongno-gu, Seoul, Korea.'}, {'ForeName': 'Jihye', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Biomedical Science, Seoul National University College of Medicine, Jongno gu, Seoul, Korea.'}, {'ForeName': 'Jiyeon', 'Initials': 'J', 'LastName': 'Choo', 'Affiliation': 'Department of Biomedical Science, Seoul National University College of Medicine, Jongno gu, Seoul, Korea.'}, {'ForeName': 'JeongHee', 'Initials': 'J', 'LastName': 'Min', 'Affiliation': 'Department of Biomedical Science, Seoul National University College of Medicine, Jongno gu, Seoul, Korea.'}, {'ForeName': 'Young Ho', 'Initials': 'YH', 'LastName': 'Yun', 'Affiliation': 'Department of Family Medicine, Seoul National University Hospital, Jongno gu, Seoul, Korea; Department of Biomedical Science, Seoul National University College of Medicine, Jongno gu, Seoul, Korea. Electronic address: lawyun08@gmail.com.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2019.12.353']
639,31924158,Pomegranate Juice does not Affect the Bioavailability of Cyclosporine in Healthy Thai Volunteers.,"BACKGROUND


It is still controversial whether pomegranate causes drug interactions. Pomegranate juice has been shown to inhibit CYP3A in-vitro and animal studies. The coadministration of pomegranate juice with cyclosporine, a narrow therapeutic drug that is the substrate of CYP3A, might lead to drug toxicity. The objective of this study is to investigate the effect of pomegranate juice on the pharmacokinetics of cyclosporine in healthy Thai volunteers.
METHODS


The study design was an open-label, randomized, single dose, crossover study with a 2- week washout period. Each fasting subject received 2 microemulsion tablets of 100 mg of cyclosporine with 500 ml of pomegranate juice (test) or 500 ml of water (control). Serial blood samples were collected up to 24 h after dosing, and blood samples were analyzed for cyclosporine concentrations by using chemiluminescent microparticle immunoassay. Fourteen healthy volunteers completed the study.
RESULTS


The 90% confidence intervals for the test/control ratio using logarithmically transformed data of area under the concentration-time curve (AUC) from time zero until the last measured concentration (AUC0-t), AUC from time zero to infinity (AUC0-∞), and maximum concentration (Cmax) were 91.6-105.6, 92.0-105.2 and 82.3-102.5, respectively. The results were within the accepted bioequivalence range for narrow therapeutic index drugs (90-111% for AUC and 80-125% for Cmax). There were no differences in adverse event between the groups.
CONCLUSION


Single dose administration of pomegranate juice with cyclosporine did not significantly affect the oral bioavailability of cyclosporine. However, further work is needed to thoroughly evaluate the effect of pomegranate on narrow therapeutic drugs.",2020,"There were no differences in adverse event between groups.
","['Healthy Thai Volunteers', 'healthy Thai volunteers', 'Fourteen healthy volunteers completed the study']","['cyclosporine with 500 ml of pomegranate juice (test) or 500 ml of water (control', 'cyclosporine', 'pomegranate juice']","['Bioavailability of Cyclosporine', 'Serial blood samples', 'adverse event', 'oral bioavailability of cyclosporine', 'concentration-time curve (AUC) from time zero until the last measured concentration (AUC0-t), AUC from time zero to infinity (AUC0-∞), and maximum concentration (Cmax']","[{'cui': 'C0337910', 'cui_str': 'Thai'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0010594', 'cui_str': 'Cyclosporins'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C1327962', 'cui_str': 'POMEGRANATE JUICE'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0005508', 'cui_str': 'Bioavailability'}, {'cui': 'C0010594', 'cui_str': 'Cyclosporins'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0919414', 'cui_str': '0 (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}]",14.0,0.0545448,"There were no differences in adverse event between groups.
","[{'ForeName': 'Wirin', 'Initials': 'W', 'LastName': 'Anlamlert', 'Affiliation': 'Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Naresuan University, Phitsanulok, Thailand.'}, {'ForeName': 'Pakawadee', 'Initials': 'P', 'LastName': 'Sermsappasuk', 'Affiliation': 'Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Naresuan University, Phitsanulok, Thailand.'}]",Current clinical pharmacology,['10.2174/1574884715666200110153125']
640,31912491,"Effect of footplate neuromuscular electrical stimulation on functional and quality-of-life parameters in patients with peripheral artery disease: pilot, and subsequent randomized clinical trial.","BACKGROUND


Supervised exercise programmes for intermittent claudication have poor access and limited compliance. Neuromuscular electrical stimulation (NMES) may be an effective alternative. A proof-of-concept study and RCT were conducted.
METHODS


In study 1, eligible patients underwent baseline assessment; treadmill testing for initial (ICD) and maximum (MCD) claudication distance; EuroQoL Five Dimensions five-level instrument (EQ-5D-5L™) and Intermittent Claudication Questionnaire (ICQ) assessment; and measurement of ultrasound haemodynamics of the superficial femoral artery. After familiarization with the NMES device, participants underwent a 30-min session of stimulation with concomitant recording of haemodynamic measures at 15 min, and after device cessation. Measurements were repeated after 6 weeks of daily use of NMES. In study 2, consecutive patients underwent baseline assessment before online randomization to a supervised exercise programme only, or adjunctive NMES treatment for 6 weeks, followed by repeat measurements.
RESULTS


Study 1 (20 patients) showed a significant improvement in MCD (46 per cent; P < 0·001) and ICD (71 per cent; P < 0·001). The RCT (42 patients) showed a significant adjunctive benefit of NMES in ICD (46 per cent; P = 0·014). Improvements were seen in the ICQ (9 points; P = 0·009) and EQ-5D-5L™ (P = 0·007) in study 1, and there was a significant adjunctive benefit of NMES on the ICQ score in patients who did supervised exercise (11·2 points; P = 0·031). Blood volume flow and time-adjusted mean velocity increased significantly with the device on (P < 0·050). Overall, NMES compliance exceeded 95 per cent.
CONCLUSION


Footplate NMES significantly improved walking distance in patients with intermittent claudication when used independently and also as an adjunct to supervised exercise. Registration number: trial 1, NCT02436200; trial 2, NCT02429310 (http://www.clinicaltrials.gov).",2020,"Improvements were seen in the ICQ (9 points; P = 0·009) and EQ-5D-5L™ (P = 0·007) in study 1, and there was a significant adjunctive benefit of NMES on the ICQ score in patients who did supervised exercise (11·2 points; P = 0·031).","['eligible patients underwent baseline assessment', 'patients with intermittent claudication', 'patients with peripheral artery disease']","['Neuromuscular electrical stimulation (NMES', 'supervised exercise programme only, or adjunctive NMES treatment', 'footplate neuromuscular electrical stimulation', 'NMES', 'Footplate NMES']","['walking distance', 'Blood volume flow and time-adjusted mean velocity', 'treadmill testing for initial (ICD) and maximum (MCD) claudication distance; EuroQoL Five Dimensions five-level instrument (EQ-5D-5L™) and Intermittent Claudication Questionnaire (ICQ) assessment; and measurement of ultrasound haemodynamics of the superficial femoral artery', 'MCD', 'Overall, NMES compliance', 'ICQ score', 'functional and quality-of-life parameters']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0021775', 'cui_str': 'Intermittent Claudication'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Artery Disease'}]","[{'cui': 'C0013786', 'cui_str': 'Electrical Stimulation'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}, {'cui': 'C0005850', 'cui_str': 'Blood Volume'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0087110', 'cui_str': 'Treadmill Test'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0429887', 'cui_str': 'Claudication distance (observable entity)'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C4551823', 'cui_str': 'instruments'}, {'cui': 'C0021775', 'cui_str': 'Intermittent Claudication'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0447106', 'cui_str': 'Superficial femoral artery (body structure)'}, {'cui': 'C1636149', 'cui_str': 'Mcd'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.243268,"Improvements were seen in the ICQ (9 points; P = 0·009) and EQ-5D-5L™ (P = 0·007) in study 1, and there was a significant adjunctive benefit of NMES on the ICQ score in patients who did supervised exercise (11·2 points; P = 0·031).","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Babber', 'Affiliation': 'Section of Vascular Surgery, Department of Surgery and Cancer, Imperial College London, London, UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Ravikumar', 'Affiliation': 'Section of Vascular Surgery, Department of Surgery and Cancer, Imperial College London, London, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Onida', 'Affiliation': 'Section of Vascular Surgery, Department of Surgery and Cancer, Imperial College London, London, UK.'}, {'ForeName': 'T R A', 'Initials': 'TRA', 'LastName': 'Lane', 'Affiliation': 'Section of Vascular Surgery, Department of Surgery and Cancer, Imperial College London, London, UK.'}, {'ForeName': 'A H', 'Initials': 'AH', 'LastName': 'Davies', 'Affiliation': 'Section of Vascular Surgery, Department of Surgery and Cancer, Imperial College London, London, UK.'}]",The British journal of surgery,['10.1002/bjs.11398']
641,31721430,Impact of high on-treatment platelet reactivity on outcomes following PCI in patients on hemodialysis: An ADAPT-DES substudy.,"OBJECTIVES


We sought to compare clinical outcomes after percutaneous coronary intervention (PCI) in patients on versus not on hemodialysis (HD) and examine whether high on-treatment platelet reactivity (HPR) further impacts outcomes among patients on HD.
BACKGROUND


Both chronic kidney disease (CKD) and HPR are predictors of major adverse cardiac events (MACE) after PCI.
METHODS


Two-year outcomes of patients from the prospective, multicenter ADAPT-DES study (N = 8,582) were analyzed according to HD status at enrollment. All patients underwent platelet function testing with the VerifyNow assay; HPR on clopidogrel was defined as P2Y12 reaction units (PRU) >208.
RESULTS


Compared with non-HD patients, patients on HD (n = 85) had significantly higher baseline PRU (median 254 vs. 188, p = .001) and more frequently had HPR (61.7% vs. 42.5%, p < .001). HD was associated with increased 2-year rates of MACE (death, myocardial infarction (MI) or definite stent thrombosis (ST); 23.4% vs. 10.7%, p < .001). HD was also strongly associated with 2-year overall mortality, cardiac death, MI, target vessel revascularization, major bleeding, stroke and ST. Following adjustment for HPR and other covariates, HD was independently associated with overall mortality, MI, ST, and major bleeding at 2 years. The relationship between HD status and 2-year MACE was consistent in patients with and without HPR (P interaction  = .78).
CONCLUSIONS


Nearly two-thirds of patients on HD exhibited HPR on clopidogrel, and both HD and HPR were independently associated with 2-year adverse outcomes after DES implantation. However, the deleterious impact of HD on clinical outcomes was present in both patients with and without HPR.",2020,"HD was associated with increased 2-year rates of MACE (death, myocardial infarction (MI) or definite stent thrombosis (ST); 23.4% vs. 10.7%, p < .001).","['patients on versus not on hemodialysis (HD', 'patients on hemodialysis', 'patients on HD', 'patients with and without HPR']","['PCI', 'percutaneous coronary intervention (PCI']","['baseline PRU', 'HPR', '2-year rates of MACE (death, myocardial infarction (MI) or definite stent thrombosis (ST', 'HD status and 2-year MACE', '2-year overall mortality, cardiac death, MI, target vessel revascularization, major bleeding, stroke and ST', 'overall mortality, MI, ST, and major bleeding', '2-year adverse outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0349381', 'cui_str': 'Mace (substance)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0439544', 'cui_str': 'Definite (qualifier value)'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0376297', 'cui_str': 'Cardiac Death'}, {'cui': 'C0449618', 'cui_str': 'Target vessel (attribute)'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}]",,0.0289423,"HD was associated with increased 2-year rates of MACE (death, myocardial infarction (MI) or definite stent thrombosis (ST); 23.4% vs. 10.7%, p < .001).","[{'ForeName': 'Geoffrey A', 'Initials': 'GA', 'LastName': 'Rubin', 'Affiliation': 'NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Ajay J', 'Initials': 'AJ', 'LastName': 'Kirtane', 'Affiliation': 'NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Shmuel', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Redfors', 'Affiliation': 'NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Giora', 'Initials': 'G', 'LastName': 'Weisz', 'Affiliation': 'Clinical Trails Center, Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': 'Usman', 'Initials': 'U', 'LastName': 'Baber', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Yiran', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Clinical Trails Center, Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': 'Thomas D', 'Initials': 'TD', 'LastName': 'Stuckey', 'Affiliation': 'LeBauer-Brodie Center for Cardiovascular Research and Education/Cone Health, Greensboro, North Carolina.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Witzenbichler', 'Affiliation': 'Helios Amper-Klinikum, Dachau, Germany.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Rinaldi', 'Affiliation': 'Sanger Heart and Vascular Institute/Atrium Health, Charlotte, North Carolina.'}, {'ForeName': 'Franz-Josef', 'Initials': 'FJ', 'LastName': 'Neumann', 'Affiliation': 'Heart Center, University of Freiburg, Bad Krozingen, Germany.'}, {'ForeName': 'D Christopher', 'Initials': 'DC', 'LastName': 'Metzger', 'Affiliation': 'Ballad Health CVA Heart Institute, Kingsport, Tennessee.'}, {'ForeName': 'Timothy D', 'Initials': 'TD', 'LastName': 'Henry', 'Affiliation': 'The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital, Cincinnati, Ohio.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Cox', 'Affiliation': 'CVA Brookwood Baptist Hospital, Birmingham, Alabama.'}, {'ForeName': 'Peter L', 'Initials': 'PL', 'LastName': 'Duffy', 'Affiliation': 'Reid Heart Center, FirstHealth of the Carolinas, Pinehurst, North Carolina.'}, {'ForeName': 'Bruce R', 'Initials': 'BR', 'LastName': 'Brodie', 'Affiliation': 'LeBauer-Brodie Center for Cardiovascular Research and Education/Cone Health, Greensboro, North Carolina.'}, {'ForeName': 'Ernest L', 'Initials': 'EL', 'LastName': 'Mazzaferri', 'Affiliation': 'The Ohio State University Wexner Medical Center, Columbus, Ohio.'}, {'ForeName': 'Roxana', 'Initials': 'R', 'LastName': 'Mehran', 'Affiliation': 'Clinical Trails Center, Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': 'Ziad A', 'Initials': 'ZA', 'LastName': 'Ali', 'Affiliation': 'NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Ori', 'Initials': 'O', 'LastName': 'Ben-Yehuda', 'Affiliation': 'NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': 'Clinical Trails Center, Cardiovascular Research Foundation, New York, New York.'}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.28577']
642,31929374,Intravenous Ibuprofen Reduces Opioid Consumption During the Initial 48 Hours After Injury in Orthopedic Trauma Patients.,"OBJECTIVES


To evaluate the efficacy of intravenous (IV) ibuprofen (Caldolor) administration in the management of acute pain in orthopedic trauma patients and to minimize opioid use.
DESIGN


Randomized controlled trial, double-blind, parallel, placebo-controlled.
SETTING


Level 1 Trauma Center.
PATIENTS


A total of 99 consecutive orthopedic trauma patients with fractures of the ribs, face, extremities, and/or pelvis were randomized to receive either 800 mg IV ibuprofen (53 patients) or placebo (44 patients) administered every 6 hours for a total of 8 doses within 48 hours of admission and the same PRN medications along with 20-mg IV/PO Pepcid twice a day. To establish pain reduction efficacy, the analysis was consequently performed in the modified intent-to-treat group that included 74 randomized subjects with a baseline pain score greater than 2. The primary outcomes were reduction in opioid consumption and decrease in pain intensity (PI).
INTERVENTION


Administration of study medications.
OUTCOME MEASUREMENTS


PI measured by Numerical Rating Scale, opioid consumption adjusted to morphine equivalent dose, and time to first narcotic administration.
RESULTS


The 2 groups had comparable baseline characteristics: age, sex distribution, mechanism of injury, type of injury, injury severity score, and PI. IV ibuprofen statistically significantly reduced opioid consumption compared with placebo during the initial 48-hour period (P = 0.017). PI calculated as PI differences was statistically different only at 8-hour interval after Caldolor administration. Time to first narcotic medication was significantly longer in the Caldolor group (hazard ratio: 1.640; 95% confidence interval, 1.009-2.665; P = 0.046).
CONCLUSIONS


IV ibuprofen provided adequate analgesia, prolonged time to first narcotic administration, and was opioid-sparing for the treatment of pain in orthopedic trauma patients, which makes Caldolor a recommended candidate for managing acute pain in the diverse orthopaedic trauma population.
LEVEL OF EVIDENCE


Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.",2020,"CONCLUSIONS


IV ibuprofen provided adequate analgesia, prolonged time to first narcotic administration and was opioid-sparing for the treatment of pain in orthopedic trauma patients, which makes Caldolor® a recommended candidate for managing acute pain in the diverse orthopaedic trauma population.
","['74 randomized subjects with a baseline pain score greater than 2', 'Orthopedic Trauma Patients', 'orthopedic trauma patients', '99 consecutive orthopedic trauma patients with fractures of the ribs, face, extremities and/or pelvis']","['ibuprofen', 'Intravenous Ibuprofen', 'placebo', 'IV ibuprofen', 'ibuprofen (Caldolor®', '800 mg intravenous (IV) ibuprofen']","['Pain intensity measured by Numerical Rating Scale, opioid consumption adjusted to morphine equivalent dose and time to first narcotic administration', 'Opioid Consumption', 'Pain intensity calculated as pain intensity differences', 'Time to first narcotic medication', 'reduction in opioid consumption and decrease in pain intensity', 'opioid consumption']","[{'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0035561', 'cui_str': 'Ribs'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0030797', 'cui_str': 'Pelvic Region'}]","[{'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2702462', 'cui_str': 'Caldolor'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0027415', 'cui_str': 'Narcotics'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0444686', 'cui_str': 'Calculated (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}]",74.0,0.533767,"CONCLUSIONS


IV ibuprofen provided adequate analgesia, prolonged time to first narcotic administration and was opioid-sparing for the treatment of pain in orthopedic trauma patients, which makes Caldolor® a recommended candidate for managing acute pain in the diverse orthopaedic trauma population.
","[{'ForeName': 'Russell D', 'Initials': 'RD', 'LastName': 'Weisz', 'Affiliation': 'Delray Medical Center, Delray Beach, FL.'}, {'ForeName': 'Alexander A', 'Initials': 'AA', 'LastName': 'Fokin', 'Affiliation': 'Delray Medical Center, Delray Beach, FL.'}, {'ForeName': 'Vivian', 'Initials': 'V', 'LastName': 'Lerner', 'Affiliation': 'Delray Medical Center, Delray Beach, FL.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Flynt', 'Affiliation': 'PharPoint Research, Durham, NC.'}, {'ForeName': 'Ines', 'Initials': 'I', 'LastName': 'Macias-Perez', 'Affiliation': 'Cumberland Pharmaceuticals, Nashville, TN.'}, {'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'Pavliv', 'Affiliation': 'Cumberland Pharmaceuticals, Nashville, TN.'}, {'ForeName': 'Maggie', 'Initials': 'M', 'LastName': 'Crawford', 'Affiliation': 'Delray Medical Center, Delray Beach, FL.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Puente', 'Affiliation': 'Delray Medical Center, Delray Beach, FL.'}]",Journal of orthopaedic trauma,['10.1097/BOT.0000000000001733']
643,31914959,Advancing successful implementation of task-shifted mental health care in low-resource settings (BASIC): protocol for a stepped wedge cluster randomized trial.,"BACKGROUND


The mental health treatment gap-the difference between those with mental health need and those who receive treatment-is high in low- and middle-income countries. Task-shifting has been used to address the shortage of mental health professionals, with a growing body of research demonstrating the effectiveness of mental health interventions delivered through task-shifting. However, very little research has focused on how to embed, support, and sustain task-shifting in government-funded systems with potential for scale up. The goal of the Building and Sustaining Interventions for Children (BASIC) study is to examine implementation policies and practices that predict adoption, fidelity, and sustainment of a mental health intervention in the education sector via teacher delivery and the health sector via community health volunteer delivery.
METHODS


BASIC is a Hybrid Type II Implementation-Effectiveness trial. The study design is a stepped wedge, cluster randomized trial involving 7 sequences of 40 schools and 40 communities surrounding the schools. Enrollment consists of 120 teachers, 120 community health volunteers, up to 80 site leaders, and up to 1280 youth and one of their primary guardians. The evidence-based mental health intervention is a locally adapted version of Trauma-focused Cognitive Behavioral Therapy, called Pamoja Tunaweza. Lay counselors are trained and supervised in Pamoja Tunaweza by local trainers who are experienced in delivering the intervention and who participated in a Train-the-Trainer model of skills transfer. After the first sequence completes implementation, in-depth interviews are conducted with initial implementing sites' counselors and leaders. Findings are used to inform delivery of implementation facilitation for subsequent sequences' sites. We use a mixed methods approach including qualitative comparative analysis to identify necessary and sufficient implementation policies and practices that predict 3 implementation outcomes of interest: adoption, fidelity, and sustainment. We also examine child mental health outcomes and cost of the intervention in both the education and health sectors.
DISCUSSION


The BASIC study will provide knowledge about how implementation of task-shifted mental health care can be supported in government systems that already serve children and adolescents. Knowledge about implementation policies and practices from BASIC can advance the science of implementation in low-resource contexts.
TRIAL REGISTRATION


Trial Registration: ClinicalTrials.gov Identifier: NCT03243396. Registered 9th August 2017, https://clinicaltrials.gov/ct2/show/NCT03243396.",2020,"The evidence-based mental health intervention is a locally adapted version of Trauma-focused Cognitive Behavioral Therapy, called Pamoja Tunaweza.","['7 sequences of 40 schools and 40 communities surrounding the schools', '120 teachers, 120 community health volunteers, up to 80\xa0site leaders, and up to 1280 youth\xa0and one\xa0of their primary guardians', 'Children (BASIC']",[],[],"[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1282914', 'cui_str': 'Surrounding (qualifier value)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C1274041', 'cui_str': 'Guardian'}, {'cui': 'C0008059', 'cui_str': 'Child'}]",[],[],7.0,0.096861,"The evidence-based mental health intervention is a locally adapted version of Trauma-focused Cognitive Behavioral Therapy, called Pamoja Tunaweza.","[{'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Dorsey', 'Affiliation': 'Department of Psychology, University of Washington Guthrie Hall 119A, Box 351525, Seattle, WA, 98195, USA. dorsey2@uw.edu.'}, {'ForeName': 'Christine L', 'Initials': 'CL', 'LastName': 'Gray', 'Affiliation': 'Center for Health Policy and Inequalities Research, Duke Global Health Institute, Duke University, Campus Box 90392, Durham, NC, 27710, USA.'}, {'ForeName': 'Augustine I', 'Initials': 'AI', 'LastName': 'Wasonga', 'Affiliation': 'Research Department, Ace Africa Kenya, P.O. Box 1185, Bungoma, 50200, Kenya.'}, {'ForeName': 'Cyrilla', 'Initials': 'C', 'LastName': 'Amanya', 'Affiliation': 'Research Department, Ace Africa Kenya, P.O. Box 1185, Bungoma, 50200, Kenya.'}, {'ForeName': 'Bryan J', 'Initials': 'BJ', 'LastName': 'Weiner', 'Affiliation': 'Department of Global Health, University of Washington, Harris Hydraulics Laboratory, 1510 San Juan Road, Seattle, WA, 98195, USA.'}, {'ForeName': 'C Micha', 'Initials': 'CM', 'LastName': 'Belden', 'Affiliation': 'Center for Health Policy and Inequalities Research, Duke Global Health Institute, Duke University, Campus Box 90392, Durham, NC, 27710, USA.'}, {'ForeName': 'Prerna', 'Initials': 'P', 'LastName': 'Martin', 'Affiliation': 'Department of Psychology, University of Washington Guthrie Hall 119A, Box 351525, Seattle, WA, 98195, USA.'}, {'ForeName': 'Rosemary D', 'Initials': 'RD', 'LastName': 'Meza', 'Affiliation': 'Department of Psychology, University of Washington Guthrie Hall 119A, Box 351525, Seattle, WA, 98195, USA.'}, {'ForeName': 'Andrew K', 'Initials': 'AK', 'LastName': 'Weinhold', 'Affiliation': 'Center for Health Policy and Inequalities Research, Duke Global Health Institute, Duke University, Campus Box 90392, Durham, NC, 27710, USA.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Soi', 'Affiliation': 'Department of Global Health, University of Washington, Harris Hydraulics Laboratory, 1510 San Juan Road, Seattle, WA, 98195, USA.'}, {'ForeName': 'Laura K', 'Initials': 'LK', 'LastName': 'Murray', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, 624 N. Broadway, 8th floor, Baltimore, MD, 21205, USA.'}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Lucid', 'Affiliation': 'Department of Psychology, University of Washington Guthrie Hall 119A, Box 351525, Seattle, WA, 98195, USA.'}, {'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Turner', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University School of Medicine, Duke University, Durham, NC, 27710, USA.'}, {'ForeName': 'Robyn', 'Initials': 'R', 'LastName': 'Mildon', 'Affiliation': 'Centre for Evidence and Implementation, 33 Lincoln Square South, Carlton, Victoria, 3053, Australia.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Whetten', 'Affiliation': 'Center for Health Policy and Inequalities Research, Duke Global Health Institute, Duke University, Campus Box 90392, Durham, NC, 27710, USA.'}]",BMC psychiatry,['10.1186/s12888-019-2364-4']
644,31942918,Efficacy of an m-Health Physical Activity and Sleep Intervention to Improve Sleep Quality in Middle-Aged Adults: The Refresh Study Randomized Controlled Trial.,"BACKGROUND


Poor sleep health is highly prevalent. Physical activity is known to improve sleep quality but not specifically targeted in sleep interventions.
PURPOSE


To compare the efficacy of a combined physical activity and sleep intervention with a sleep-only intervention and a wait-list control, for improving sleep quality in middle-aged adults without a diagnosed sleep disorder.
METHODS


Three-arm randomized controlled trial (Physical Activity and Sleep Health (PAS), Sleep Health Only (SO), Wait-list Control (CON) groups; 3-month primary time-point, 6-month follow-up) of 275 (PAS = 110, SO = 110, CON = 55) inactive adults (40-65 years) reporting poor sleep quality. The main intervention component was a smartphone/tablet ""app"" to aid goal setting and self-monitoring physical activity and/or sleep hygiene behaviors (including stress management), and a pedometer for PAS group. Primary outcome was Pittsburgh Sleep Quality Index (PSQI) global score. Secondary outcomes included several self-reported physical activity measures and PSQI subcomponents. Group differences were examined stepwise, first between pooled intervention (PI = PAS + SO) and CON groups, then between PAS and SO groups.
RESULTS


Compared with CON, PI groups significantly improved PSQI global and subcomponents scores at 3 and 6 months. There were no differences in sleep quality between PAS and SO groups. The PAS group reported significantly less daily sitting time at 3 months and was significantly more likely to report ≥2 days/week resistance training and meeting physical activity guidelines at 6 months than the SO group.
CONCLUSIONS


PIs had statistically significantly improved sleep quality among middle-aged adults with poor sleep quality without a diagnosed sleep disorder. The adjunctive physical activity intervention did not additionally improve sleep quality.
CLINICAL TRIAL INFORMATION


Australian New Zealand Clinical Trial Registry: ACTRN12617000680369; Universal Trial number: U1111-1194-2680; Human Research Ethics Committee, Blinded by request of journal: H-2016-0267.",2020,"The PAS group reported significantly less daily sitting time at 3 months and was significantly more likely to report ≥2 days/week resistance training and meeting physical activity guidelines at 6 months than the SO group.
","['Australian New Zealand Clinical Trial Registry', 'middle-aged adults with poor sleep quality without a diagnosed sleep disorder', 'middle-aged adults without a diagnosed sleep disorder', 'Middle-Aged Adults']","['combined physical activity and sleep intervention with a sleep-only intervention and a wait-list control', 'm-Health Physical Activity and Sleep Intervention', 'Physical Activity and Sleep Health (PAS), Sleep Health Only (SO', 'adjunctive physical activity intervention', 'Wait-list Control (CON', 'smartphone/tablet ""app"" to aid goal setting and self-monitoring physical activity and/or sleep hygiene behaviors (including stress management), and a pedometer for PAS group', 'CON']","['Pittsburgh Sleep Quality Index (PSQI) global score', 'poor sleep quality', 'Sleep Quality', 'several self-reported physical activity measures and PSQI subcomponents', 'sleep quality', 'PSQI global and subcomponents scores', 'daily sitting time']","[{'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0235162', 'cui_str': 'Difficulty sleeping (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0851578', 'cui_str': 'Sleep Disorders'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0449435', 'cui_str': 'Aid (attribute)'}, {'cui': 'C0150598', 'cui_str': 'Goal setting (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C4277672', 'cui_str': 'Sleep Hygiene'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0150788', 'cui_str': 'Manage stress control'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C3697468', 'cui_str': 'PSQI - Pittsburgh sleep quality index'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0235162', 'cui_str': 'Difficulty sleeping (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",,0.106602,"The PAS group reported significantly less daily sitting time at 3 months and was significantly more likely to report ≥2 days/week resistance training and meeting physical activity guidelines at 6 months than the SO group.
","[{'ForeName': 'Anna T', 'Initials': 'AT', 'LastName': 'Rayward', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, School of Medicine & Public Health, University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'Murawski', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, School of Medicine & Public Health, University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Mitch J', 'Initials': 'MJ', 'LastName': 'Duncan', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, School of Medicine & Public Health, University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Elizabeth G', 'Initials': 'EG', 'LastName': 'Holliday', 'Affiliation': 'School of Medicine & Public Health, University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Corneel', 'Initials': 'C', 'LastName': 'Vandelanotte', 'Affiliation': 'Physical Activity Research Group, School for Health, Medical and Applied Sciences, Central Queensland University, Rockhampton, Queensland, Australia.'}, {'ForeName': 'Wendy J', 'Initials': 'WJ', 'LastName': 'Brown', 'Affiliation': 'School of Human Movement and Nutrition Sciences, The University of Queensland, St Lucia, Queensland, Australia.'}, {'ForeName': 'Ronald C', 'Initials': 'RC', 'LastName': 'Plotnikoff', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, School of Education, University of Newcastle, Callaghan, New South Wales, Australia.'}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1093/abm/kaz064']
645,31577372,Randomized controlled trial of plain English and visual abstracts for disseminating surgical research via social media.,"BACKGROUND


Patients are increasingly taking an active role in the design and delivery of surgical research. Public communication of results should also be encouraged, but this is often limited to non-expert commentary. This study assessed the role of plain English abstracts disseminated via social media in engaging patients and clinicians in the communication of surgical research.
METHODS


A three-arm randomized controlled trial with crossover of two intervention arms was performed. Manuscripts accepted for publication in BJS were allocated to one of three arms and disseminated via Twitter: plain English abstracts, visual abstracts and standard tweets. The primary outcome was online engagement (a composite of tweets, replies and likes) by members of the public within 14 days. The secondary outcome was online engagement by healthcare professionals.
RESULTS


Forty-one manuscripts were randomized to plain English abstracts (14), visual abstracts (14) and standard tweets (13). The number of public engagements was low, with a mean of 1·8 (range 0-8), 2·5 (0-11), and 1·2 (0-4) for plain English abstracts, visual abstracts and standard tweets respectively. The mean number of engagements by healthcare professionals was 29·4 (6-66), 45·3 (6-161) and 28·8 (10-52) respectively. Overall, visual abstracts attracted a significantly greater number of engagements than plain English ones (P < 0·001).
CONCLUSION


Online, public engagement with surgical research was low. Overall engagement (predominantly from healthcare professionals) was enhanced by the use of visual abstracts.",2019,"Overall, visual abstracts attracted a significantly greater number of engagements than plain English ones (P < 0·001).
",['Forty-one manuscripts'],['plain English and visual abstracts'],"['number of public engagements', 'Overall engagement', 'mean number of engagements by healthcare professionals', 'online engagement (a composite of tweets, replies and likes', 'online engagement by healthcare professionals']",[],"[{'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0600678', 'cui_str': 'Abstracts'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1704312', 'cui_str': 'Healthcare professional (occupation)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}]",,0.217618,"Overall, visual abstracts attracted a significantly greater number of engagements than plain English ones (P < 0·001).
","[{'ForeName': 'S J', 'Initials': 'SJ', 'LastName': 'Chapman', 'Affiliation': ""Leeds Institute of Medical Research at St. James's, University of Leeds, Leeds, UK.""}, {'ForeName': 'R C', 'Initials': 'RC', 'LastName': 'Grossman', 'Affiliation': 'Buckinghamshire Healthcare NHS Trust, Amersham, UK.'}, {'ForeName': 'M E B', 'Initials': 'MEB', 'LastName': 'FitzPatrick', 'Affiliation': 'Translational Gastroenterology Unit, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'R R W', 'Initials': 'RRW', 'LastName': 'Brady', 'Affiliation': 'Newcastle Centre for Bowel Disease Research Group, Newcastle Upon Tyne Hospitals NHS Foundation Trust and Newcastle University, Newcastle upon Tyne, UK.'}]",The British journal of surgery,['10.1002/bjs.11307']
646,31917731,RETINAL LEAKAGE INDEX DYNAMICS ON ULTRA-WIDEFIELD FLUORESCEIN ANGIOGRAPHY IN EYES TREATED WITH INTRAVITREAL AFLIBERCEPT FOR PROLIFERATIVE DIABETIC RETINOPATHY IN THE RECOVERY STUDY.,"PURPOSE


Characterization of leakage indices on ultra-widefield fluorescein angiography in proliferative diabetic retinopathy treated with intravitreal aflibercept.
METHODS


Prospective study enrolling subjects for treatment of proliferative diabetic retinopathy randomized 1:1 to receive 2-mg intravitreal aflibercept every 4 weeks (2q4) or every 12 weeks (2q12). Ultra-widefield fluorescein angiography images obtained at baseline, 24, and 48 weeks were analyzed using a semiautomated leakage segmentation platform. Panretinal and zonal leakage indices were calculated.
RESULTS


Forty eyes of 40 subjects were included, and mean age was 48 ± 12.1 years. Mean number of injections was 11 ± 1.7 in the 2q4 arm and 4 ± 0.4 in the 2q12 arm. Median baseline leakage index in the 2q4 and 2q12 groups was 5.1% and 4.3%, respectively (P = 0.28). At 24 and 48 weeks, the 2q4 group significantly improved to 1.1% (-79%, P < 0.0001). At Week 24, the 2q12 group demonstrated nonsignificant improvement (3.4%; -21%, P = 0.47); by Week 48, improvement was significant (1.4%; -68%, P = 0.02). The 2q4 group resulted in lower leakage index compared with the 2q12 group at 24 weeks (1.1% vs. 3.4%, respectively; P = 0.008), but by 48 weeks, leakage index was similar between both groups (1.1% vs. 1.4%, respectively; P = 0.34).
CONCLUSION


Proliferative diabetic retinopathy treated with intravitreal aflibercept demonstrated significant leakage index reductions at 1 year. Monthly dosing provided more rapid reduction in leakage index compared with quarterly dosing.
TRIAL REGISTRATION


RECOVERY study (NCT02863354); https://clinicaltrials.gov/ct2/show/NCT02863354.",2020,"At Week 24, the 2q12 group demonstrated nonsignificant improvement (3.4%; -21%, P = 0.47); by Week 48, improvement was significant (1.4%; -68%, P = 0.02).","['Prospective study enrolling subjects for treatment of proliferative diabetic retinopathy', 'proliferative diabetic retinopathy treated with intravitreal aflibercept', 'Forty eyes of 40 subjects were included, and mean age was 48 ± 12.1 years']","['intravitreal aflibercept', 'ultra-widefield fluorescein angiography', '2-mg intravitreal aflibercept']","['lower leakage index', 'leakage index reductions', 'leakage index', 'Panretinal and zonal leakage indices', 'Median baseline leakage index', 'Mean number of injections']","[{'cui': 'C0033522', 'cui_str': 'Prospective Studies'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0154830', 'cui_str': 'PDR - proliferative diabetic retinopathy'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C0016313', 'cui_str': 'Fluorescein Angiography'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0015376', 'cui_str': 'Extravasation (morphologic abnormality)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0442132', 'cui_str': 'Panretinal (qualifier value)'}, {'cui': 'C1564799', 'cui_str': 'Zonal'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]",40.0,0.0459298,"At Week 24, the 2q12 group demonstrated nonsignificant improvement (3.4%; -21%, P = 0.47); by Week 48, improvement was significant (1.4%; -68%, P = 0.02).","[{'ForeName': 'Amy S', 'Initials': 'AS', 'LastName': 'Babiuch', 'Affiliation': 'Vitreoretinal Service, Cole Eye Institute, Cleveland Clinic Foundation, Cleveland, Ohio.'}, {'ForeName': 'Charles C', 'Initials': 'CC', 'LastName': 'Wykoff', 'Affiliation': 'Retina Consultants of Houston, Houston, Texas.'}, {'ForeName': 'Sunil K', 'Initials': 'SK', 'LastName': 'Srivastava', 'Affiliation': 'Vitreoretinal Service, Cole Eye Institute, Cleveland Clinic Foundation, Cleveland, Ohio.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Talcott', 'Affiliation': 'Vitreoretinal Service, Cole Eye Institute, Cleveland Clinic Foundation, Cleveland, Ohio.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Zhou', 'Affiliation': 'Retina Consultants of Houston, Houston, Texas.'}, {'ForeName': 'Jenna', 'Initials': 'J', 'LastName': 'Hach', 'Affiliation': 'The Tony and Leona Campane Center for Excellence for Image-Guided Surgery and Advanced Imaging Research, Cole Eye Institute, Cleveland Clinic Foundation, Cleveland, Ohio.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Hu', 'Affiliation': 'The Tony and Leona Campane Center for Excellence for Image-Guided Surgery and Advanced Imaging Research, Cole Eye Institute, Cleveland Clinic Foundation, Cleveland, Ohio.'}, {'ForeName': 'Jamie L', 'Initials': 'JL', 'LastName': 'Reese', 'Affiliation': 'Vitreoretinal Service, Cole Eye Institute, Cleveland Clinic Foundation, Cleveland, Ohio.'}, {'ForeName': 'Justis P', 'Initials': 'JP', 'LastName': 'Ehlers', 'Affiliation': 'Vitreoretinal Service, Cole Eye Institute, Cleveland Clinic Foundation, Cleveland, Ohio.'}]","Retina (Philadelphia, Pa.)",['10.1097/IAE.0000000000002727']
647,31675174,MRI-Based Radiomics: Associations With the Recurrence-Free Survival of Patients With Hepatocellular Carcinoma Treated With Conventional Transcatheter Arterial Chemoembolization.,"BACKGROUND


Preoperative estimation of hepatocellular carcinoma (HCC) recurrence after conventional transcatheter arterial chemoembolization (c-TACE) is crucial for subsequent follow-up and therapy decisions.
PURPOSE


To evaluate the associations of radiomics models based on pretreatment contrast-enhanced MRI, a clinical-radiological model and a combined model with the recurrence-free survival (RFS) of patients with HCC after c-TACE, and to develop a radiomics nomogram for individual RFS estimations and risk stratification.
STUDY TYPE


Retrospective.
POPULATION


In all, 184 consecutive HCC patients.
FIELD STRENGTH/SEQUENCE


1.5T or 3.0T, including T 2  WI, T 1  WI, and contrast-enhanced T 1  WI.
ASSESSMENT


All HCC patients were randomly divided into the training (n = 110) and validation datasets (n = 74). Radiomics signatures capturing intratumoral and peritumoral expansion (1, 3, and 5 mm) were constructed, and the radiomics models were set up using least absolute shrinkage and selection operator (LASSO) Cox regression. Clinical-radiological features were identified by univariate and multivariate Cox regression. The clinical-radiological model and the combined model fusing the radiomics signature with the clinical-radiological risk factors were developed by a multivariate Cox proportional hazard model. A radiomics nomogram derived from the combined model was established.
STATISTICAL TESTS


LASSO Cox regression, univariate and multivariate Cox regression, Kaplan-Meier analysis were performed. The discrimination performance of each model was quantified by the C-index.
RESULTS


Among the different peritumoral expansion models, only the 3-mm peritumoral expansion model (C-index, 0.714) showed a comparable performance (P = 0.4087) to that of the portal venous phase intratumoral model (C-index, 0.727). The combined model showed the best performance and the C-index was 0.802. Kaplan-Meier analysis showed that the cutoff values of the combined model relative to a median value (1.7426) perfectly stratified these patients into high-risk and low-risk subgroups.
DATA CONCLUSION


The combined model is more valuable than the clinical-radiological model or radiomics model alone for evaluating the RFS of HCC patients after c-TACE, and the radiomics nomogram can be used to preoperatively and individually estimate RFS.
LEVEL OF EVIDENCE


3 Technical Efficacy Stage: 4 J. Magn. Reson. Imaging 2020;52:461-473.",2020,"The combined model is more valuable than the clinical-radiological model or radiomics model alone for evaluating the RFS of HCC patients after c-TACE, and the radiomics nomogram can be used to preoperatively and individually estimate RFS.
","['184 consecutive HCC patients', 'patients with HCC after c']","['MRI-Based Radiomics', 'conventional transcatheter arterial chemoembolization (c-TACE', 'Conventional Transcatheter Arterial Chemoembolization', 'TACE']",[],"[{'cui': 'C4517616', 'cui_str': 'One hundred and eighty-four'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C2711393', 'cui_str': 'Transarterial chemoembolization of hepatic artery'}, {'cui': 'C0529196', 'cui_str': 'ADAM-17 Protein'}]",[],184.0,0.0126853,"The combined model is more valuable than the clinical-radiological model or radiomics model alone for evaluating the RFS of HCC patients after c-TACE, and the radiomics nomogram can be used to preoperatively and individually estimate RFS.
","[{'ForeName': 'Wenlong', 'Initials': 'W', 'LastName': 'Song', 'Affiliation': 'Department of Radiology, Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Xiangling', 'Initials': 'X', 'LastName': 'Yu', 'Affiliation': 'Department of Radiology, Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Dajing', 'Initials': 'D', 'LastName': 'Guo', 'Affiliation': 'Department of Radiology, Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Huan', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'GE Healthcare, Shanghai, China.'}, {'ForeName': 'Zhuoyue', 'Initials': 'Z', 'LastName': 'Tang', 'Affiliation': 'Department of Radiology, Chongqing General Hospital, Chongqing, China.'}, {'ForeName': 'Xinjie', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Radiology, Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Department of Radiology, Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Haiping', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Radiology, Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Yangyang', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Radiology, Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Radiology, Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}]",Journal of magnetic resonance imaging : JMRI,['10.1002/jmri.26977']
648,31935388,The effect of antenatal counseling and intrauterine device insertion services on postpartum contraceptive use in Nepal: Results from a stepped-wedge randomized controlled trial.,"OBJECTIVE


There is high unmet need for family planning in the postpartum period in Nepal. The current study assessed the effects of a contraceptive counseling and postpartum intrauterine device (PPIUD) insertion intervention on use of contraception in the postpartum period.
STUDY DESIGN


We utilized a cluster, stepped-wedge design to randomly assign two hospital clusters (compromised of six hospitals) to begin the intervention at time one or time two. From 2015 to 2017, women completed surveys after delivery but before discharge (n = 75,893), and then at one year and two years postpartum. We estimated the intent-to-treat effect of the intervention using weighted, linear probability models and the adherence-adjusted effect (antenatal counseling) using an instrumental variable approach. Outcomes included modern contraceptive use and method mix measured at one and two years postpartum in a sample of 19,298 women (year I follow-up sample) and a sample of 19,248 women (year II follow-up sample). We used inverse probability weights to adjust for incomplete follow-up and bootstrap methods to give correct causal inference with the small number of six clusters.
RESULTS


The intervention increased use of modern contraceptives by 3.8 percentage points [95% CI: -0.1, 9.5] at one-year postpartum, but only 0.3 percentage points [95% CI: -3.7, 4.1] at two years. The intervention significantly increased the use of PPIUDs at one year and two years postpartum, but there was less use of sterilization. Only 42% of women were counseled during the intervention period. The adherence-adjusted effects (antenatal counseling) were four times larger than the intent-to-treat effects.
CONCLUSIONS


Providing counseling during the antenatal period and PPIUD services in hospitals increased use of PPIUDs in the one- and two-year postpartum period and shifted the contraceptive method mix.
IMPLICATIONS


In order for antenatal counseling to increase postpartum contraceptive use, counseling may need to be provided in a wider range of prenatal care settings and at multiple time points. Healthcare providers should be trained on contraceptive counseling and PPIUD insertion, with the goal of expanding the available method mix and meeting postpartum women's contraceptive needs.",2020,"The intervention increased use of modern contraceptives by 3.8 percentage points [95% CI: -0.1, 9.5] at one-year postpartum, but only 0.3 percentage points [95% CI: -3.7, 4.1] at two years.","['19298 women (year I follow-up sample) and a sample of 19248 women (year II follow-up sample', 'Postpartum Contraceptive Use in Nepal']","['Antenatal Counseling and Intrauterine Device Insertion Services', 'contraceptive counseling and postpartum intrauterine device (PPIUD) insertion intervention']","['adherence-adjusted effects (antenatal counseling', 'modern contraceptive use and method mix']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0009871', 'cui_str': 'Contraceptives'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0027689', 'cui_str': 'Federal Democratic Republic of Nepal'}]","[{'cui': 'C2828394', 'cui_str': 'Antenatal (qualifier value)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0021900', 'cui_str': 'Contraceptive Devices, Intrauterine'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0009871', 'cui_str': 'Contraceptives'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}]","[{'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C2828394', 'cui_str': 'Antenatal (qualifier value)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0009871', 'cui_str': 'Contraceptives'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C1720722', 'cui_str': 'Mix'}]",,0.0789826,"The intervention increased use of modern contraceptives by 3.8 percentage points [95% CI: -0.1, 9.5] at one-year postpartum, but only 0.3 percentage points [95% CI: -3.7, 4.1] at two years.","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Huber-Krum', 'Affiliation': 'Global Health and Population, Harvard T.H. Chan School of Public Health, Boston, MA, USA. Electronic address: shuber@hsph.harvard.edu.'}, {'ForeName': 'Aayush', 'Initials': 'A', 'LastName': 'Khadka', 'Affiliation': 'Global Health and Population, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Elina', 'Initials': 'E', 'LastName': 'Pradhan', 'Affiliation': 'The World Bank Group, Washington, D.C., USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Rohr', 'Affiliation': 'Global Health and Population, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Mahesh', 'Initials': 'M', 'LastName': 'Puri', 'Affiliation': 'Center for Research on Environment, Health and Population Activities (CREHPA), Kathmandu, Nepal.'}, {'ForeName': 'Dev', 'Initials': 'D', 'LastName': 'Maharjan', 'Affiliation': 'Center for Research on Environment, Health and Population Activities (CREHPA), Kathmandu, Nepal.'}, {'ForeName': 'Saugat', 'Initials': 'S', 'LastName': 'Joshi', 'Affiliation': 'Center for Research on Environment, Health and Population Activities (CREHPA), Kathmandu, Nepal.'}, {'ForeName': 'Iqbal', 'Initials': 'I', 'LastName': 'Shah', 'Affiliation': 'Global Health and Population, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Canning', 'Affiliation': 'Global Health and Population, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}]",Contraception,['10.1016/j.contraception.2019.12.014']
649,31910819,"Study Protocol effectiveness of a nutritional intervention based on encouraging the consumption of unprocessed and minimally processed foods and the practice of physical activities for appropriate weight gain in overweight, adult, pregnant women: a randomized controlled trial.","BACKGROUND


Evidence from observational studies suggests that a greater intake of ultra-processed foods during pregnancy is associated with a higher chance of obesity, increased gestational weight gain, and neonatal adiposity. The aim of the present study is to evaluate the effectiveness of a nutritional intervention based on encouraging the consumption of unprocessed and minimally processed foods and the practice of physical activities for appropriate weight gain in overweight, adult, pregnant women. Additionally, the effect of the intervention on pregnancy outcomes, neonatal adiposity, and the child's weight and height will be investigated.
METHODS


This is a two-armed parallel randomized controlled trial that will be conducted at primary health units in Ribeirão Preto, SP, Brazil. Adult pregnant women who are overweight and receiving prenatal care in the public health system will be included. The women will be randomly allocated into control (standard care) or intervention groups. Those enrolled in the intervention group will participate in three individualized nutritional counselling sessions based on encouraging the consumption of unprocessed and minimally processed foods and the practice of physical activities. The recruitment of the participants will be carried out at seven health facilities over 12 months, with a sample of 300 women expected. Maternal anthropometric, sociodemographic, blood pressure, biochemical, and lifestyle data will be obtained at baseline (up to the 16th week of gestation), and during a second assessment (34th to 36th gestational week). The neonate body composition will be estimated after birth, and data on pregnancy outcomes, weight and height of children at 6, 12 and 24 months of age will be further obtained from medical records.
DISCUSSION


This will be the first randomized controlled trial to test the effectiveness of a nutritional intervention based on encouraging the consumption of unprocessed and minimally processed foods and the practice of physical activities for appropriate weight gain in adult, overweight, pregnant women. Furthermore, the effect of the intervention on pregnancy outcomes, neonatal adiposity and the child's weight and height will be evaluated.
TRIAL REGISTRATION


Registro Brasileiro de Ensaios Clínicos (Rebec) RBR-2w9bhc July 30th 2018 (http://www.ensaiosclinicos.gov.br/rg/?q=RBR-2w9bhc+), and RBR-7yx36h June 4th 2019 (http://www.ensaiosclinicos.gov.br/rg/?q=RBR-7yx36h+0.",2020,"Furthermore, the effect of the intervention on pregnancy outcomes, neonatal adiposity and the child's weight and height will be evaluated.
","['participants will be carried out at seven health facilities over 12 months, with a sample of 300 women expected', 'primary health units in Ribeirão Preto, SP, Brazil', 'Adult pregnant women who are overweight and receiving prenatal care in the public health system will be included', 'overweight, adult, pregnant women', 'adult, overweight, pregnant women']","['individualized nutritional counselling sessions based on encouraging the consumption of unprocessed and minimally processed foods and the practice of physical activities', 'nutritional intervention']","['Maternal anthropometric, sociodemographic, blood pressure, biochemical, and lifestyle data', ""pregnancy outcomes, neonatal adiposity and the child's weight and height"", 'gestational weight gain, and neonatal adiposity', ""pregnancy outcomes, neonatal adiposity, and the child's weight and height""]","[{'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0018704', 'cui_str': 'Health Facilities'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0033052', 'cui_str': 'Antenatal Care'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0344355', 'cui_str': 'Convenience Foods'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C1563743', 'cui_str': 'Adiposis'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1398625', 'cui_str': 'Pregnancy Weight Gain'}]",300.0,0.0694028,"Furthermore, the effect of the intervention on pregnancy outcomes, neonatal adiposity and the child's weight and height will be evaluated.
","[{'ForeName': 'Daniela Saes', 'Initials': 'DS', 'LastName': 'Sartorelli', 'Affiliation': 'Department of Social Medicine, Ribeirão Preto Medical School, University of São Paulo, Brazil, Avenida Bandeirantes, 3900, Ribeirão Preto, SP, 14049-900, Brazil. daniss@fmrp.usp.br.'}, {'ForeName': 'Lívia Castro', 'Initials': 'LC', 'LastName': 'Crivellenti', 'Affiliation': 'Graduate Program of Public Health, Ribeirão Preto Medical School, University of São Paulo, Brazil, Avenida Bandeirantes, 3900, Ribeirão Preto, SP, 14049-900, Brazil.'}, {'ForeName': 'Marina Garcia', 'Initials': 'MG', 'LastName': 'Manochio-Pina', 'Affiliation': 'Program in Health Promotion, University of Franca, Avenida Dr. Armando Salles Oliveira, 201, Franca, SP, 14404-600, Brazil.'}, {'ForeName': 'Naiara Franco', 'Initials': 'NF', 'LastName': 'Baroni', 'Affiliation': 'Graduate Program of Public Health, Ribeirão Preto Medical School, University of São Paulo, Brazil, Avenida Bandeirantes, 3900, Ribeirão Preto, SP, 14049-900, Brazil.'}, {'ForeName': 'Mariana Rinaldi', 'Initials': 'MR', 'LastName': 'Carvalho', 'Affiliation': 'Graduate Program of Public Health, Ribeirão Preto Medical School, University of São Paulo, Brazil, Avenida Bandeirantes, 3900, Ribeirão Preto, SP, 14049-900, Brazil.'}, {'ForeName': 'Rosa Wanda', 'Initials': 'RW', 'LastName': 'Diez-Garcia', 'Affiliation': 'Department of Health Sciences, Ribeirão Preto Medical School, University of São Paulo, Brazil, Avenida Bandeirantes, 3900, Ribeirão Preto, SP, 14049-900, Brazil.'}, {'ForeName': 'Laércio Joel', 'Initials': 'LJ', 'LastName': 'Franco', 'Affiliation': 'Department of Social Medicine, Ribeirão Preto Medical School, University of São Paulo, Brazil, Avenida Bandeirantes, 3900, Ribeirão Preto, SP, 14049-900, Brazil.'}]",BMC pregnancy and childbirth,['10.1186/s12884-019-2672-1']
650,31553517,Stage I hypertension is associated with impaired systolic function by strain imaging compared with prehypertension: A report from the prever study.,"High blood pressure (BP) is associated with higher rates of cardiovascular events, even in stage I hypertension (HTN) and prehypertension (preHTN). Lower left ventricular (LV) systolic function, assessed by global longitudinal strain (GLS), has been demonstrated in individuals with HTN compared to individuals with normal BP, but a comparison of individuals with preHTN and stage I HTN was not described to date. The PREVER study includes two randomized double-blind controlled trials, performed in volunteers with preHTN (PREVER-prevention trial) or stage I HTN (PREVER-treatment trial), aged 30-70 years. A subsample of patients of both trials had GLS measured from 2D echocardiograms performed at baseline and after 18 months of follow-up. We compared baseline data from both studies and, among stage I HTN patients, clinical and echocardiographic correlates of GLS were determined. Participants with preHTN (n = 91;53% female; 55 ± 9 yo) and stage I HTN (n = 105; 44% female; 55 ± 8 yo) had similar clinical parameters beyond the expected differences in BP levels. Participants with stage I HTN had lower GLS (-17.5 ± 2.5% vs -18.2 ± 2.4%, P = .03) compared with those with preHTN. In stage I HTN, lower GLS was associated with lower e' and lower LV ejection fraction. In conclusion, patients in Stage I HTN may already express changes in GLS compared with individuals with preHTN, suggesting that even mildly difference in BP can be impact in subclinical systolic function.",2019,"Participants with stage I HTN had lower GLS (-17.5 ± 2.5% vs -18.2 ± 2.4%, P = .03) compared with those with preHTN.","['patients in Stage', 'aged 30-70\xa0years', 'Participants with preHTN (n\xa0=\xa091;53% female; 55\xa0±\xa09\xa0yo) and stage I HTN (n\xa0=\xa0105; 44% female; 55\xa0±\xa08\xa0yo', 'volunteers with preHTN (PREVER-prevention trial) or stage']",['strain imaging compared with prehypertension'],"['BP levels', 'lower GLS', 'LV ejection fraction', 'Lower left ventricular (LV) systolic function, assessed by global longitudinal strain (GLS', 'High blood pressure (BP']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}]","[{'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C1696708', 'cui_str': 'Pre-Hypertension'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal (qualifier value)'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C0020538', 'cui_str': 'Blood Pressure, High'}]",,0.306836,"Participants with stage I HTN had lower GLS (-17.5 ± 2.5% vs -18.2 ± 2.4%, P = .03) compared with those with preHTN.","[{'ForeName': 'Angela B S', 'Initials': 'ABS', 'LastName': 'Santos', 'Affiliation': 'Division of Cardiology, Hospital de Clinicas de Porto Alegre, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Murilo', 'Initials': 'M', 'LastName': 'Foppa', 'Affiliation': 'Division of Cardiology, Hospital de Clinicas de Porto Alegre, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Bertoluci', 'Affiliation': 'Division of Cardiology, Hospital de Clinicas de Porto Alegre, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Thais V', 'Initials': 'TV', 'LastName': 'Branchi', 'Affiliation': 'Division of Cardiology, Hospital de Clinicas de Porto Alegre, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Sandra C', 'Initials': 'SC', 'LastName': 'Fuchs', 'Affiliation': 'Postgraduate Studies Program in Cardiology, School of Medicine, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Flávio D', 'Initials': 'FD', 'LastName': 'Fuchs', 'Affiliation': 'Division of Cardiology, Hospital de Clinicas de Porto Alegre, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}]","Journal of clinical hypertension (Greenwich, Conn.)",['10.1111/jch.13695']
651,31906840,"Vitamin D and Calcium Supplement Attenuate Bone Loss among HIVInfected Patients Receiving Tenofovir Disoproxil Fumarate/Emtricitabine/ Efavirenz: An Open-Label, Randomized Controlled Trial.","BACKGROUND


Antiretroviral therapy (ART), especially with tenofovir disoproxil fumarate (TDF), has been associated with accelerated bone turnover and leads to significant bone loss.
OBJECTIVE


We aimed to determine the effect of vitamin D2 and calcium on bone mineral density (BMD) in HIV-infected patients receiving TDF/emtricitabine (FTC)/efavirenz (EFV).
METHODS


A prospective, open-label, randomized controlled study was conducted. Eligible patients were ART naïve HIV individuals who initiated TDF/FTC/EFV. The study group received supplementation with vitamin D2 and calcium carbonate, whereas the control group was administered only ART. The primary outcome was the percentage change in total hip BMD at week 24 compared with baseline.
RESULTS


A total of 18 patients were randomized (9 in each group). The mean (standard deviation; SD) total hip BMD significantly decreased from baseline in both groups, from 0.96 (0.14) g/cm2 to 0.93 (0.13) g/cm2 in the study group (p = 0.006) and from 0.87 (0.11) g/cm2 to 0.84 (0.11) g/cm2 in the control group (p = 0.004). The mean (SD) lumbar spine BMD significantly decreased from baseline in both groups, from 1.00 (0.13) g/cm2 to 0.97 (0.13) g/cm2 (p = 0.004) in the study group and from 0.90 (0.09) g/cm3 to 0.86 (0.08) g/cm2 in the control group (p = 0.006). At week 24, the mean (SD) lumbar spine BMD was significantly greater in the study group than in the control group (p = 0.042). However, there were no significant differences in the percentage change of total hip, lumbar spine, and femoral neck BMD between both groups. No adverse events were reported. In conclusion, as early as 24 weeks after TDF initiation, a significant decline in BMD was detected.
CONCLUSION


Vitamin D2 and calcium supplements should be considered for HIV-infected patients receiving TDF/FTC/EFV in a resource-limited setting where there are limited ART options (Clinicaltrials. gov NCT0287643).",2020,"At week 24, the mean (SD) lumbar spine BMD was significantly greater in the study group than in the control group (p = 0.042).","['18 patients', 'HIV-infected patients receiving TDF/emtricitabine (FTC)/efavirenz (EFV', 'Eligible patients were ART naïve HIV individuals who initiated TDF/FTC/EFV', 'HIV-infected Patients Receiving']","['tenofovir disoproxil fumarate (TDF', 'Vitamin D and Calcium Supplement', 'Tenofovir Disoproxil Fumarate/Emtricitabine/Efavirenz', 'supplementation with vitamin D2 and calcium carbonate', 'vitamin D2 and calcium', 'Vitamin D2 and calcium supplements']","['BMD', 'mean (standard deviation; SD) total hip BMD', 'mean (SD) lumbar spine BMD', 'percentage change of total hip, lumbar spine, and femoral neck BMD', 'bone mineral density (BMD', 'percentage change in total hip BMD', 'adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C3540037', 'cui_str': 'Calcium supplement (substance)'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}, {'cui': 'C0674428', 'cui_str': 'efavirenz'}, {'cui': 'C0014695', 'cui_str': 'Ergocalciferol'}, {'cui': 'C0006681', 'cui_str': 'Calcium Carbonate'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C3887615', 'cui_str': 'Lumbar spine structure (body structure)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0015815', 'cui_str': 'Femoral Neck'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0746104,"At week 24, the mean (SD) lumbar spine BMD was significantly greater in the study group than in the control group (p = 0.042).","[{'ForeName': 'Patawee', 'Initials': 'P', 'LastName': 'Boontanondha', 'Affiliation': 'Department of Medicine, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, 10400, Thailand.'}, {'ForeName': 'Hataikarn', 'Initials': 'H', 'LastName': 'Nimitphong', 'Affiliation': 'Department of Medicine, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, 10400, Thailand.'}, {'ForeName': 'Suchawadee', 'Initials': 'S', 'LastName': 'Musikarat', 'Affiliation': 'Department of Diagnostic and Therapeutic Radiology, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, 10400, Thailand.'}, {'ForeName': 'Aschara', 'Initials': 'A', 'LastName': 'Ragkho', 'Affiliation': 'Department of Pathology, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, 10400, Thailand.'}, {'ForeName': 'Sasisopin', 'Initials': 'S', 'LastName': 'Kiertiburanakul', 'Affiliation': 'Department of Medicine, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, 10400, Thailand.'}]",Current HIV research,['10.2174/1570162X18666200106150806']
652,31618495,Safety and efficacy of taurine as an add-on treatment for tics in youngsters.,"BACKGROUND AND PURPOSE


The pathophysiological model of tics generally describes disruption of γ-aminobutyric acid transmission, and taurine is found to be an agonist of γ-aminobutyric acid receptors. The study aimed to evaluate the safety and efficacy of taurine as an add-on treatment for tics.
METHODS


Four hundred and four youngsters with tic disorders were randomly assigned to 12 weeks of either oral taurine or placebo. The Yale Global Tic Severity Scale was used to measure tic severity. The primary outcome measure was global severity scores reduced by more than 60% compared with baseline scores.
RESULTS


Three hundred and eighty-two patients were successfully treated. At week 4, no significant differences were found in the treatment effect and the total occurrence of adverse drug reactions between the taurine and placebo groups. At week 12, the proportion of significant improvement in tics was significantly higher in the taurine group than the placebo group (53.4% with taurine versus 34.5% without taurine; relative risk 1.546; P < 0.001), and no group differences were found in the total occurrence of adverse drug reactions.
CONCLUSIONS


Taurine is safe and effective for tics.",2020,"At week 12, the proportion of significant improvement in tics was significantly higher in the taurine group than the placebo group (53.4% with taurine versus 34.5% without taurine; Relative Risk = 1.546; P<0.001), and no group differences were found in the total occurrence of adverse drug reactions.
","['382 patients were successfully treated', '404 youngsters with tic disorders', 'tics in the youngsters']","['placebo', 'oral taurine or placebo', 'Taurine', 'taurine']","['proportion of significant improvement in tics', 'Safety and efficacy', 'total occurrence of adverse drug reactions', 'treatment effect and total occurrence of adverse drug reactions', 'safe and effective on tics', 'global severity scores', 'Yale Global Tic Severity Scale']","[{'cui': 'C4517750', 'cui_str': 'Three hundred and eighty-two'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0040188', 'cui_str': 'Tic disorder (disorder)'}, {'cui': 'C0278076', 'cui_str': 'Habit Chorea'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0039350', 'cui_str': 'Taurine'}]","[{'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0278076', 'cui_str': 'Habit Chorea'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0041755', 'cui_str': 'Drug Side Effects'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0457451', 'cui_str': 'Severity score (qualifier value)'}, {'cui': 'C4720888', 'cui_str': 'Yale global tic severity scale (assessment scale)'}]",382.0,0.299969,"At week 12, the proportion of significant improvement in tics was significantly higher in the taurine group than the placebo group (53.4% with taurine versus 34.5% without taurine; Relative Risk = 1.546; P<0.001), and no group differences were found in the total occurrence of adverse drug reactions.
","[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Ding', 'Affiliation': 'Department of Epidemiology and Health Statistics, The Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'Department of Child Health Care, The Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Liu', 'Affiliation': 'Department of Epidemiology and Health Statistics, The Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Ran', 'Affiliation': 'Department of Child Health Care, The Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Yi', 'Affiliation': 'Department of Child Health Care, The Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Neurosurgery, The Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Zhao', 'Affiliation': 'Department of Neurology, The Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Tang', 'Affiliation': 'Department of Neurology, The Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Cheng', 'Affiliation': 'Department of Customer Service, The Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Department of Pharmacology, The Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurology, The Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Ji', 'Affiliation': 'Department of Neurology, The Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Department of Prenatal Diagnosis, The Affiliated Hospital of Qingdao University, Qingdao, China.'}]",European journal of neurology,['10.1111/ene.14107']
653,31913413,Breast Conservation After Neoadjuvant Chemotherapy for Triple-Negative Breast Cancer: Surgical Results From the BrighTNess Randomized Clinical Trial.,"Importance


Neoadjuvant systemic therapy (NST) is often administered to enable breast-conserving therapy (BCT) in stages II to III breast cancer.
Objectives


To prospectively evaluate the role of NST in conversion from BCT ineligibility to BCT eligibility and to assess the association of response to NST, germline BRCA (gBRCA) status, and region of treatment with surgical choice in women with triple-negative breast cancer (TNBC).
Design, Setting, and Participants


This prespecified secondary analysis of a multicentered, phase 3, double-blind, randomized clinical trial (BrighTNess) enrolled 634 eligible women across 145 centers in 15 countries in North America, Europe, and Asia. Women with operable, clinical stages II to III TNBC who underwent gBRCA mutation testing before initiating NST were eligible to participate. Data were collected from April 1, 2014, to December 8, 2016. This preplanned analysis was performed from January 5, 2018, to October 28, 2019.
Interventions


Study participants were randomized to receive 12 weeks of weekly paclitaxel alone or with the addition of carboplatin and/or veliparib, followed by 4 cycles of doxorubicin hydrochloride and cyclophosphamide.
Main Outcomes and Measures


Surgeons assessed BCT candidacy by clinical and radiographic criteria before and after NST. Surgical choices and whether BCT eligibility was associated with the likelihood of pathologic complete response were then analyzed.
Results


Among the 634 randomized patients (median age, 51 [range, 22-78] years), pre- and post-NST assessments were available for 604 patients. Of 141 patients deemed BCT ineligible at baseline, 75 (53.2%) converted to BCT eligible. Overall, 342 (68.1%) of 502 patients deemed BCT eligible after NST underwent BCT, including 42 (56.0%) of the 75 who converted to BCT eligible. Patients treated in Europe and Asia were more likely to undergo BCT (odds ratio, 2.66; 95% CI, 1.84-3.84) compared with those treated in North America. Among patients without gBRCA mutation undergoing mastectomy, those treated in North America were more likely to undergo contralateral prophylactic mastectomy (57 of 81 [70.4%] vs 6 of 30 [20.0%]; P < .001). Rates of pathologic complete response were similar between patients deemed BCT eligible at baseline and those who were BCT ineligible but converted to BCT eligibility after NST (55.3 [235 of 425] vs 49.3% [37 of 75]; P = .38).
Conclusions and Relevance


This prospective analysis of NST and BCT eligibility in TNBC demonstrates a conversion from BCT ineligibility to BCT eligibility of 53.2%. Lower BCT rates among eligible patients and higher bilateral mastectomy rates among patients without gBRCA mutation in North America merit investigation.
Trial Registration


ClinicalTrials.gov identifier: NCT02032277.",2020,"Rates of pathologic complete response were similar between patients deemed BCT eligible at baseline and those who were BCT ineligible but converted to BCT eligibility after NST (55.3 [235 of 425] vs 49.3% [37 of 75]; P = .38).
","['634 randomized patients (median age, 51 [range, 22-78] years), pre- and post-NST assessments were available for 604 patients', '141 patients deemed BCT ineligible at baseline, 75 (53.2%) converted to BCT eligible', '634 eligible women across 145 centers in 15 countries in North America, Europe, and Asia', '502 patients deemed BCT eligible after NST underwent BCT, including 42 (56.0%) of the 75 who converted to BCT eligible', 'Triple-Negative Breast Cancer', 'Women with operable, clinical stages II to III TNBC who underwent gBRCA mutation testing before initiating NST were eligible to participate', 'women with triple-negative breast cancer (TNBC']","['Neoadjuvant systemic therapy (NST', 'doxorubicin hydrochloride and cyclophosphamide', 'Neoadjuvant Chemotherapy', 'NST', 'paclitaxel alone or with the addition of carboplatin and/or veliparib']","['Lower BCT rates', 'BCT candidacy by clinical and radiographic criteria', 'bilateral mastectomy rates', 'contralateral prophylactic mastectomy', 'Rates of pathologic complete response']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C4517572', 'cui_str': 'One hundred and forty-one'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C3539878', 'cui_str': 'Triple Negative Breast Cancer'}, {'cui': 'C0205188', 'cui_str': 'Operable (qualifier value)'}, {'cui': 'C0205571', 'cui_str': 'Clinical stage II (finding)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0546861', 'cui_str': 'Doxorubicin Hydrochloride'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C1958300', 'cui_str': 'veliparib'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0191877', 'cui_str': 'Bilateral mastectomy (procedure)'}, {'cui': 'C1705768'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]",634.0,0.17405,"Rates of pathologic complete response were similar between patients deemed BCT eligible at baseline and those who were BCT ineligible but converted to BCT eligibility after NST (55.3 [235 of 425] vs 49.3% [37 of 75]; P = .38).
","[{'ForeName': 'Mehra', 'Initials': 'M', 'LastName': 'Golshan', 'Affiliation': ""Department of Surgery, Dana-Farber Cancer Institute, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Sibylle', 'Initials': 'S', 'LastName': 'Loibl', 'Affiliation': 'Department of Medical Oncology, German Breast Group, Neu-Isenburg, Germany.'}, {'ForeName': 'Stephanie M', 'Initials': 'SM', 'LastName': 'Wong', 'Affiliation': 'Department of Surgery, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Jens Bodo', 'Initials': 'JB', 'LastName': 'Houber', 'Affiliation': 'Department of Medical Oncology, University of Ulm, Ulm, Germany.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': ""O'Shaughnessy"", 'Affiliation': 'Department of Medical Oncology, Texas Oncology-Baylor Sammons Cancer Center, US Oncology, Dallas.'}, {'ForeName': 'Hope S', 'Initials': 'HS', 'LastName': 'Rugo', 'Affiliation': 'Department of Medical Oncology, University of California, San Francisco.'}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Wolmark', 'Affiliation': 'Department of Surgery, Allegheny General Hospital, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'McKee', 'Affiliation': 'AbbVie, Inc, North Chicago, Illinois.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Maag', 'Affiliation': 'AbbVie, Inc, North Chicago, Illinois.'}, {'ForeName': 'Danielle M', 'Initials': 'DM', 'LastName': 'Sullivan', 'Affiliation': 'AbbVie, Inc, North Chicago, Illinois.'}, {'ForeName': 'Otto', 'Initials': 'O', 'LastName': 'Metzger-Filho', 'Affiliation': ""Department of Surgery, Dana-Farber Cancer Institute, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Gunter', 'Initials': 'G', 'LastName': 'Von Minckwitz', 'Affiliation': 'Department of Medical Oncology, University of Ulm, Ulm, Germany.'}, {'ForeName': 'Charles E', 'Initials': 'CE', 'LastName': 'Geyer', 'Affiliation': 'Department of Medical Oncology, Virginia Commonwealth University Massey Cancer Center, Richmond.'}, {'ForeName': 'William M', 'Initials': 'WM', 'LastName': 'Sikov', 'Affiliation': 'Department of Medical Oncology, Women and Infants Hospital of Rhode Island, Providence.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Untch', 'Affiliation': 'Department of Breast Surgery, Helios Klinikum Berlin-Buch, Berlin, Germany.'}]",JAMA surgery,['10.1001/jamasurg.2019.5410']
654,31904685,"Promotion of Regular Oesophageal Motility to Prevent Regurgitation and Enhance Nutrition Intake in Long-Stay ICU Patients. A Multicenter, Phase II, Sham-Controlled, Randomized Trial: The PROPEL Study.","OBJECTIVES


To evaluate the effect of esophageal stimulation on nutritional adequacy in critically ill patients at risk for enteral feeding intolerance.
DESIGN


A multicenter randomized sham-controlled clinical trial.
SETTING


Twelve ICUs in Canada.
PATIENTS


We included mechanically ventilated ICU patients who were given moderate-to-high doses of opioids and expected to remain alive and ventilated for an additional 48 hours and who were receiving enteral nutrition or expected to start imminently.
INTERVENTIONS


Patients were randomly assigned 1:1 to esophageal stimulation via an esophageal stimulating catheter (E-Motion Tube; E-Motion Medical, Tel Aviv, Israel) or sham treatment. All patients were fed via these catheters using a standardized feeding protocol.
MEASUREMENTS AND MAIN RESULTS


The co-primary outcomes were proportion of caloric and protein prescription received enterally over the initial 7 days following randomization. Among 159 patients randomized, the modified intention-to-treat analysis included 155 patients: 73 patients in the active treatment group and 82 in the sham treatment group. Over the 7-day study period, the percent of prescribed caloric intake (± SE) received by the enteral route was 64% ± 2 in the active group and 65% ± 2 in sham patients for calories (difference, -1; 95% CI, -8 to 6; p = 0.74). For protein, it was 57% ± 3 in the active group and 60% ± 3 in the sham group (difference, -3; 95% CI, -10 to 3; p = 0.30). Compared to the sham group, there were more serious adverse events reported in the active treatment group (13 vs 6; p = 0.053). Clinically important arrhythmias were detected by Holter monitoring in 36 out of 70 (51%) in the active group versus 22 out of 76 (29%) in the sham group (p = 0.006).
CONCLUSIONS


Esophageal stimulation via a special feeding catheter did not improve nutritional adequacy and was associated with increase risk of harm in critically ill patients.",2020,"Clinically important arrhythmias were detected by Holter monitoring in 36 out of 70 (51%) in the active group versus 22 out of 76 (29%) in the sham group (p = 0.006).
","['Twelve ICUs in Canada', '159 patients randomized, the modified intention-to-treat analysis included 155 patients: 73 patients in the active treatment group and 82 in the sham treatment group', 'critically ill patients at risk for enteral feeding intolerance', 'We included mechanically ventilated ICU patients who were given moderate-to-high doses of opioids and expected to remain alive and ventilated for an additional 48 hours and who were receiving enteral nutrition or expected to start imminently', 'Long-Stay ICU Patients', 'critically ill patients']","['esophageal stimulation', 'esophageal stimulation via an esophageal stimulating catheter (E-Motion Tube; E-Motion Medical, Tel Aviv, Israel) or sham treatment']","['serious adverse events', 'nutritional adequacy', 'risk of harm', 'proportion of caloric and protein prescription received enterally', 'Clinically important arrhythmias']","[{'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C3665892', 'cui_str': 'Enteral feeding intolerance'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0439586', 'cui_str': '48 hours (qualifier value)'}, {'cui': 'C0086225', 'cui_str': 'Enteral Feeding'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}]","[{'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0687704', 'cui_str': 'Motions (qualifier value)'}, {'cui': 'C4318415', 'cui_str': 'Tube (unit of presentation)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0022271', 'cui_str': 'Israel'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}]",159.0,0.383065,"Clinically important arrhythmias were detected by Holter monitoring in 36 out of 70 (51%) in the active group versus 22 out of 76 (29%) in the sham group (p = 0.006).
","[{'ForeName': 'Daren K', 'Initials': 'DK', 'LastName': 'Heyland', 'Affiliation': ''}, {'ForeName': 'Francois', 'Initials': 'F', 'LastName': 'Marquis', 'Affiliation': ""CIUSSS de-l'Est-de-l'Île-de-Montréal - Hôpital Maisonneuve-Rosemont, Montreal, QC, Canada.""}, {'ForeName': 'Francois', 'Initials': 'F', 'LastName': 'Lamontagne', 'Affiliation': 'Department of Critical Care Medicine, Université de Sherbrooke, Sherbrooke, QC, Canada.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Albert', 'Affiliation': 'Centre de Recherche Hôpital du Sacré-Coeur de Montréal, Université de Montréal, Montréal, QC, Canada.'}, {'ForeName': 'Alexis F', 'Initials': 'AF', 'LastName': 'Turgeon', 'Affiliation': 'CHU de Québec - Université Laval Research Center, Population Health and Optimal Health Practices Research Unit, (Traumatology-Emergency-Critical Care Medicine), Université Laval, Québec City, QC, Canada.'}, {'ForeName': 'Kosar A', 'Initials': 'KA', 'LastName': 'Khwaja', 'Affiliation': 'Departments of Surgery and Critical Care Medicine, McGill University Health Centre, Montreal, QC, Canada.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Garland', 'Affiliation': 'Department of Medicine, University of Manitoba, Winnipeg, MB, Canada.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Hall', 'Affiliation': 'Nova Scotia Health Authority and the Department of Critical Care Medicine Dalhousie University, Halifax, NS, Canada.'}, {'ForeName': 'Martin G', 'Initials': 'MG', 'LastName': 'Chapman', 'Affiliation': 'Department of Critical Care Medicine, Sunnybrook Health Sciences Centre, Toronto, ON, Canada.'}, {'ForeName': 'Demetrios J', 'Initials': 'DJ', 'LastName': 'Kutsiogannis', 'Affiliation': 'Department of Critical Care Medicine, Faculty of Medicine and Dentistry, The University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Martin', 'Affiliation': 'Division of Critical Care Medicine, Department of Medicine, London Health Sciences Centre & Schulich School of Medicine and Dentistry, Western University, London, ON, Canada.'}, {'ForeName': 'Daniel I', 'Initials': 'DI', 'LastName': 'Sessler', 'Affiliation': 'Department of Outcomes Research, Anesthesiology Institute, Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'Andrew G', 'Initials': 'AG', 'LastName': 'Day', 'Affiliation': 'Clinical Evaluation Research Unit, Kingston General Hospital, Kingston, ON, Canada.'}]",Critical care medicine,['10.1097/CCM.0000000000004176']
655,31870634,Bone resorption is unchanged by liraglutide in type 2 diabetes patients: A randomised controlled trial.,"BACKGROUND


Liraglutide, a glucagon-like peptide-1 receptor agonist, has well known beneficial effects on glucose metabolism, and animal studies indicate that liraglutide also affects bone turnover by decreasing bone resorption. The primary objective of the study was to investigate the effect of liraglutide on bone turnover in patients with T2D.
METHODS


The study was a randomized, double-blinded, clinical trial. Sixty participants with T2D were randomized to treatment with liraglutide 1.8 mg daily or placebo for 26 weeks. The primary endpoint was change in p-collagen I cross-linked C-terminal telopeptide (p-CTX).
RESULTS


P-CTX increased in patients treated with liraglutide by 0.07 (0.03; 0.10) μg/L (p < 0.001) and in patients treated with placebo by 0.03 (0.00; 0.06) μg/L (p = 0.04), however, changes were not different between the groups (p = 0.16). Weight decreased in patients treated with liraglutide from baseline to week four (p < 0.001) and remained stable thereafter. P-procollagen type 1 N-terminal propeptide (P1NP) decreased in patients treated with liraglutide from baseline to week four (p < 0.01), increased between weeks 4 and 13 (p = 0.03), and remained elevated thereafter. Weight and p-P1NP did not change in patients treated with placebo. Hip bone mineral density (BMD) decreased in placebo treated patients from baseline to end of study, whereas no changes were seen in patients treated with liraglutide (p = 0.01 difference between groups).
CONCLUSION


Liraglutide treatment for 26 weeks did not affect bone resorption and preserved hip BMD despite weight loss in patients with T2D, suggesting that liraglutide has some antiresorptive effect.",2020,Weight decreased in patients treated with liraglutide from baseline to week four (p < 0.001) and remained stable thereafter.,"['Sixty participants with T2D', 'type 2 diabetes patients', 'patients with T2D.\nMETHODS']","['liraglutide 1.8\u202fmg daily or placebo', 'Liraglutide', 'placebo', 'liraglutide']","['Weight', 'change in p-collagen', 'Weight and p-P1NP', 'bone turnover', 'bone resorption and preserved hip BMD despite weight loss', 'Hip bone mineral density (BMD', 'P-procollagen type 1\u202fN-terminal propeptide (P1NP', 'Bone resorption']","[{'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]","[{'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0085268', 'cui_str': 'Bone Turnover'}, {'cui': 'C0005974', 'cui_str': 'Osteoclastic Bone Loss'}, {'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0030786', 'cui_str': 'Hip Bone'}, {'cui': 'C0026162', 'cui_str': 'Minerals'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0033235', 'cui_str': 'Procollagen'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}]",60.0,0.425029,Weight decreased in patients treated with liraglutide from baseline to week four (p < 0.001) and remained stable thereafter.,"[{'ForeName': 'Katrine', 'Initials': 'K', 'LastName': 'Hygum', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Denmark. Electronic address: katrhygu@rm.dk.'}, {'ForeName': 'Torben', 'Initials': 'T', 'LastName': 'Harsløf', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Denmark.'}, {'ForeName': 'Niklas Rye', 'Initials': 'NR', 'LastName': 'Jørgensen', 'Affiliation': 'Department of Clinical Biochemistry, Rigshospitalet, Denmark; OPEN, Open Patient data Explorative Network, Odense University Hospital/Institute of Clinical Research, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Jørgen', 'Initials': 'J', 'LastName': 'Rungby', 'Affiliation': 'Department of Endocrinology IC/ Copenhagen Center for Translational Research, Bispebjerg University Hospital, Denmark.'}, {'ForeName': 'Steen B', 'Initials': 'SB', 'LastName': 'Pedersen', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Denmark; Steno Diabetes Center Aarhus, Aarhus University Hospital, Denmark.'}, {'ForeName': 'Bente L', 'Initials': 'BL', 'LastName': 'Langdahl', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Denmark.'}]",Bone,['10.1016/j.bone.2019.115197']
656,31828291,"Comparative Immunogenicity of Several Enhanced Influenza Vaccine Options for Older Adults: A Randomized, Controlled Trial.","BACKGROUND


Enhanced influenza vaccines may improve protection for older adults, but comparative immunogenicity data are limited. Our objective was to examine immune responses to enhanced influenza vaccines, compared to standard-dose vaccines, in community-dwelling older adults.
METHODS


Community-dwelling older adults aged 65-82 years in Hong Kong were randomly allocated (October 2017-January 2018) to receive 2017-2018 Northern hemisphere formulations of a standard-dose quadrivalent vaccine, MF59-adjuvanted trivalent vaccine, high-dose trivalent vaccine, or recombinant-hemagglutinin (rHA) quadrivalent vaccine. Sera collected from 200 recipients of each vaccine before and at 30-days postvaccination were assessed for antibodies to egg-propagated vaccine strains by hemagglutination inhibition (HAI) and to cell-propagated A/Hong Kong/4801/2014(H3N2) virus by microneutralization (MN). Influenza-specific CD4+ and CD8+ T cell responses were assessed in 20 participants per group.
RESULTS


Mean fold rises (MFR) in HAI titers to egg-propagated A(H1N1) and A(H3N2) and the MFR in MN to cell-propagated A(H3N2) were statistically significantly higher in the enhanced vaccine groups, compared to the standard-dose vaccine. The MFR in MN to cell-propagated A(H3N2) was highest among rHA recipients (4.7), followed by high-dose (3.4) and MF59-adjuvanted (2.9) recipients, compared to standard-dose recipients (2.3). Similarly, the ratio of postvaccination MN titers among rHA recipients to cell-propagated A(H3N2) recipients was 2.57-fold higher than the standard-dose vaccine, which was statistically higher than the high-dose (1.33-fold) and MF59-adjuvanted (1.43-fold) recipient ratios. Enhanced vaccines also resulted in the boosting of T-cell responses.
CONCLUSIONS


In this head-to-head comparison, older adults receiving enhanced vaccines showed improved humoral and cell-mediated immune responses, compared to standard-dose vaccine recipients.
CLINICAL TRIALS REGISTRATION


NCT03330132.",2020,"In this head-to-head comparison, older adults receiving enhanced vaccines showed improved humoral and cell-mediated immune responses, compared to standard-dose vaccine recipients.
","['older adults', '20 participants per group', 'community-dwelling older adults', 'Community-dwelling older adults aged 65-82 years in Hong Kong were randomly allocated (October 2017-January 2018) to receive 2017-2018 Northern hemisphere formulations of a', 'Older Adults']","['standard-dose quadrivalent vaccine, MF59-adjuvanted trivalent vaccine, high-dose trivalent vaccine, or recombinant-hemagglutinin (rHA) quadrivalent vaccine', 'Several Enhanced Influenza Vaccine Options']","['humoral and cell-mediated immune responses', 'Mean fold rises (MFR) in HAI titers to egg-propagated A(H1N1) and A(H3N2', 'Influenza-specific CD4+ and CD8+ T cell responses', 'ratio of postvaccination MN titers']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0019907', 'cui_str': 'Hongkong'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0289787', 'cui_str': 'MF59'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0018909', 'cui_str': 'Hemagglutinin'}, {'cui': 'C0021403', 'cui_str': 'Influenza Vaccines'}]","[{'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C0301872', 'cui_str': 'Immune response, function (observable entity)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0185026', 'cui_str': 'Plication - action (qualifier value)'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0029974', 'cui_str': 'Egg, Unfertilized'}, {'cui': 'C0021400', 'cui_str': 'Influenza, Human'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",200.0,0.0565966,"In this head-to-head comparison, older adults receiving enhanced vaccines showed improved humoral and cell-mediated immune responses, compared to standard-dose vaccine recipients.
","[{'ForeName': 'Benjamin J', 'Initials': 'BJ', 'LastName': 'Cowling', 'Affiliation': 'World Health Organization Collaborating Centre for Infectious Disease Epidemiology and Control, School of Public Health, The University of Hong Kong, Hong Kong Special Administrative Region, Hong Kong, China.'}, {'ForeName': 'Ranawaka A P M', 'Initials': 'RAPM', 'LastName': 'Perera', 'Affiliation': 'World Health Organization Collaborating Centre for Infectious Disease Epidemiology and Control, School of Public Health, The University of Hong Kong, Hong Kong Special Administrative Region, Hong Kong, China.'}, {'ForeName': 'Sophie A', 'Initials': 'SA', 'LastName': 'Valkenburg', 'Affiliation': 'World Health Organization Collaborating Centre for Infectious Disease Epidemiology and Control, School of Public Health, The University of Hong Kong, Hong Kong Special Administrative Region, Hong Kong, China.'}, {'ForeName': 'Nancy H L', 'Initials': 'NHL', 'LastName': 'Leung', 'Affiliation': 'World Health Organization Collaborating Centre for Infectious Disease Epidemiology and Control, School of Public Health, The University of Hong Kong, Hong Kong Special Administrative Region, Hong Kong, China.'}, {'ForeName': 'A Danielle', 'Initials': 'AD', 'LastName': 'Iuliano', 'Affiliation': 'Influenza Division, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.'}, {'ForeName': 'Yat Hung', 'Initials': 'YH', 'LastName': 'Tam', 'Affiliation': 'World Health Organization Collaborating Centre for Infectious Disease Epidemiology and Control, School of Public Health, The University of Hong Kong, Hong Kong Special Administrative Region, Hong Kong, China.'}, {'ForeName': 'Jennifer H F', 'Initials': 'JHF', 'LastName': 'Wong', 'Affiliation': 'World Health Organization Collaborating Centre for Infectious Disease Epidemiology and Control, School of Public Health, The University of Hong Kong, Hong Kong Special Administrative Region, Hong Kong, China.'}, {'ForeName': 'Vicky J', 'Initials': 'VJ', 'LastName': 'Fang', 'Affiliation': 'World Health Organization Collaborating Centre for Infectious Disease Epidemiology and Control, School of Public Health, The University of Hong Kong, Hong Kong Special Administrative Region, Hong Kong, China.'}, {'ForeName': 'Athena P Y', 'Initials': 'APY', 'LastName': 'Li', 'Affiliation': 'World Health Organization Collaborating Centre for Infectious Disease Epidemiology and Control, School of Public Health, The University of Hong Kong, Hong Kong Special Administrative Region, Hong Kong, China.'}, {'ForeName': 'Hau Chi', 'Initials': 'HC', 'LastName': 'So', 'Affiliation': 'World Health Organization Collaborating Centre for Infectious Disease Epidemiology and Control, School of Public Health, The University of Hong Kong, Hong Kong Special Administrative Region, Hong Kong, China.'}, {'ForeName': 'Dennis K M', 'Initials': 'DKM', 'LastName': 'Ip', 'Affiliation': 'World Health Organization Collaborating Centre for Infectious Disease Epidemiology and Control, School of Public Health, The University of Hong Kong, Hong Kong Special Administrative Region, Hong Kong, China.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Azziz-Baumgartner', 'Affiliation': 'Influenza Division, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.'}, {'ForeName': 'Alicia M', 'Initials': 'AM', 'LastName': 'Fry', 'Affiliation': 'Influenza Division, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.'}, {'ForeName': 'Min Z', 'Initials': 'MZ', 'LastName': 'Levine', 'Affiliation': 'Influenza Division, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.'}, {'ForeName': 'Shivaprakash', 'Initials': 'S', 'LastName': 'Gangappa', 'Affiliation': 'Influenza Division, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.'}, {'ForeName': 'Suryaprakash', 'Initials': 'S', 'LastName': 'Sambhara', 'Affiliation': 'Influenza Division, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.'}, {'ForeName': 'Ian G', 'Initials': 'IG', 'LastName': 'Barr', 'Affiliation': 'World Health Organization Collaborating Centre for Reference and Research, Melbourne, Victoria, Australia.'}, {'ForeName': 'Danuta M', 'Initials': 'DM', 'LastName': 'Skowronski', 'Affiliation': 'British Columbia Centre for Disease Control, Vancouver, Canada.'}, {'ForeName': 'J S Malik', 'Initials': 'JSM', 'LastName': 'Peiris', 'Affiliation': 'World Health Organization Collaborating Centre for Infectious Disease Epidemiology and Control, School of Public Health, The University of Hong Kong, Hong Kong Special Administrative Region, Hong Kong, China.'}, {'ForeName': 'Mark G', 'Initials': 'MG', 'LastName': 'Thompson', 'Affiliation': 'Influenza Division, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz1034']
657,31784435,Factors perceived to facilitate or hinder handwashing among primary students: a qualitative assessment of the Mikono Safi intervention schools in NW Tanzania.,"OBJECTIVE


To qualitatively assess the effects of a multi-modal school-based water, sanitation and hygiene (WASH) intervention on handwashing behaviour among primary students in North Western (NW) Tanzania.
DESIGN


The study was a qualitative assessment of barriers and facilitators to handwashing among students attending primary schools participating in the Mikono Safi Trial (Kiswahili for 'Clean Hands), a cluster-randomised trial assessing the impact of a school-based WASH intervention on selected soil transmitted helminth infections. Data collection methods included in-depth interviews with teachers, focus group discussions and friendship pair interviews with students collected between April and October 2018. The Capability-Opportunity-Motivation and Behaviour model was used to inform data collection and analysis.
SETTING


The study was conducted in four purposively selected intervention schools in three districts of Kagera region, NW Tanzania (Bukoba urban, Bukoba rural and Muleba districts).
PARTICIPANTS


Participants comprised 16 purposively selected teachers aged between 23 and 52 years and 100 students aged 7-15 years RESULTS: The Mikono Safi intervention increased students' reported capability and motivation to wash their hands with soap at key times, particularly after visiting the toilet. Improvements in students' handwashing knowledge and skills were reported by both teachers and students, and motivation for handwashing was enhanced by emotional drivers such as disgust, fear and nurture. Newly established handwashing stations improved the physical opportunity to wash hands, although the availability of water and the provision of soap was not always consistent (eg, due to internal organisational shortcomings or during the dry season). Students and teachers were actively engaged in intervention implementation which created a school community that valued and supported improved hand hygiene.
CONCLUSION


The intervention was successful in improving capability and motivation for handwashing. Handwashing opportunity was also greatly improved, although the supply with water and soap was sometimes interrupted, calling for much stronger multi-sectoral collaboration to improve access to water at schools.
TRIAL REGISTRATION NUMBER


ISRCTN45013173; Pre-results.",2019,"The Mikono Safi intervention increased students' reported capability and motivation to wash their hands with soap at key times, particularly after visiting the toilet.","[""students attending primary schools participating in the Mikono Safi Trial (Kiswahili for 'Clean Hands"", 'primary students in North Western (NW) Tanzania', 'Participants comprised 16 purposively selected teachers aged between 23 and 52 years and 100 students aged 7-15 years RESULTS', 'four purposively selected intervention schools in three districts of Kagera region, NW Tanzania (Bukoba urban, Bukoba rural and Muleba districts']","['school-based WASH intervention', 'Mikono Safi intervention', 'multi-modal school-based water, sanitation and hygiene (WASH) intervention']",['capability and motivation for handwashing'],"[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0557296', 'cui_str': 'Attending primary school (finding)'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0039298', 'cui_str': 'United Republic of Tanzania'}, {'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1547959', 'cui_str': 'Wash - dosing instruction imperative'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0036172', 'cui_str': 'Sanitation'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}]","[{'cui': 'C0026605', 'cui_str': 'Motivation'}]",,0.0274157,"The Mikono Safi intervention increased students' reported capability and motivation to wash their hands with soap at key times, particularly after visiting the toilet.","[{'ForeName': 'Elialilia', 'Initials': 'E', 'LastName': 'Okello', 'Affiliation': 'Mwanza Intervention Trials Unit, Mwanza, Tanzania elialilia.okello@mitu.or.tz.'}, {'ForeName': 'Saidi', 'Initials': 'S', 'LastName': 'Kapiga', 'Affiliation': 'Mwanza Intervention Trials Unit, Mwanza, Tanzania.'}, {'ForeName': 'Heiner', 'Initials': 'H', 'LastName': 'Grosskurth', 'Affiliation': 'Mwanza Intervention Trials Unit, Mwanza, Tanzania.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Makata', 'Affiliation': 'Mwanza Intervention Trials Unit, Mwanza, Tanzania.'}, {'ForeName': 'Onike', 'Initials': 'O', 'LastName': 'Mcharo', 'Affiliation': 'Mwanza Intervention Trials Unit, Mwanza, Tanzania.'}, {'ForeName': 'Safari', 'Initials': 'S', 'LastName': ""Kinungh'i"", 'Affiliation': 'National Institute for Medical Research (NIMR), Mwanza Centre, Mwanza, Tanzania.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Dreibelbis', 'Affiliation': 'Department of Disease Control, London School of Hygiene and Tropical Medicine (LSHTM), London, UK.'}]",BMJ open,['10.1136/bmjopen-2019-030947']
658,31789445,Are the cardiovascular and kidney benefits of empagliflozin influenced by baseline glucose-lowering therapy?,"AIMS


In the EMPA-REG OUTCOME® trial, the sodium-glucose cotransporter 2 inhibitor empagliflozin when given in addition to standard care improved cardiovascular (CV) and renal outcomes, and reduced mortality. Trial participants were on a variety of glucose-lowering therapies at baseline, some of which could potentially affect CV risk. This analysis investigated whether the use of background diabetes therapy affected the risk of CV death, hospitalizations for heart failure, and progression of chronic kidney disease, among patients treated with empagliflozin.
MATERIALS AND METHODS


Patients meeting inclusion and exclusion criteria were randomized to placebo, empagliflozin 10 mg or empagliflozin 25 mg; glucose-lowering therapy was to remain unchanged for 12 weeks and then adjusted to achieve glycaemic control according to local guidelines. Differences in risk of cardio-renal outcomes between empagliflozin and placebo by baseline use of metformin, sulphonylurea (SU) and insulin were assessed using a Cox proportional hazards model.
RESULTS


Of 7020 eligible patients, 74% were receiving metformin, 43% SU and 48% insulin at baseline (each alone or in combination); the most common regimens were metformin plus SU (20%) and metformin plus insulin (20%). Empagliflozin reduced the risk of CV death irrespective of the use of: metformin [with: hazard ratio (HR) 0.71 (95% confidence interval, CI, 0.54-0.94); without: 0.46 (0.32-0.68); P interaction  = 0.07]; SU [with: HR 0.64 (0.44-0.92); without: 0.61 (0.46-0.81); P interaction  = 0.85]; or insulin [with: HR 0.63 (0.46-0.85); without: 0.61 (0.44-0.85); P interaction  = 0.92]. Reductions in three-point major adverse CV events, hospitalizations for heart failure, and all-cause mortality were consistent across subgroups of baseline therapies. Empagliflozin reduced the risks of incident or worsening nephropathy versus placebo irrespective of the use of SU or insulin at baseline (P interaction  > 0.05), but there was a greater reduction in this risk for patients not using metformin [HR 0.47 (95% CI 0.37-0.59)] versus those using metformin [HR 0.68 (95% CI 0.58-0.79)] at baseline (P interaction  = 0.01).
CONCLUSIONS


The addition of empagliflozin to antihyperglycaemic regimens of patients with type 2 diabetes and CV disease consistently reduced their risks of adverse CV outcomes and mortality irrespective of baseline use of metformin, SU or insulin. For chronic kidney disease progression, there may be a larger benefit from empagliflozin in those patients who are not using metformin.",2020,"Empagliflozin reduced the risks of incident or worsening nephropathy versus placebo irrespective of use of SU or insulin at baseline (P interaction  >0.05), but there was a greater reduction in this risk for patients not using (HR 0.47","['patients with type 2 diabetes and CV disease', 'Patients meeting inclusion and exclusion criteria', '7020 eligible patients, 74% were receiving']","['placebo, empagliflozin 10 mg, or empagliflozin 25 mg; glucose-lowering therapy', 'SGLT2 inhibitor empagliflozin', 'metformin, sulfonylurea, or insulin', 'metformin, sulfonylurea, and insulin', 'metformin', 'empagliflozin and placebo', 'metformin plus SU', 'Empagliflozin', 'empagliflozin']","['risk of CV death, heart failure hospitalization, and progression of chronic kidney disease', 'risk of cardio-renal outcomes', 'risks of incident or worsening nephropathy', 'cardiovascular (CV) and renal outcomes, and reduced mortality', '3-point major adverse CV events, heart failure hospitalization, and all-cause mortality', 'risk of CV death']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3848930', 'cui_str': 'empagliflozin 10 MG'}, {'cui': 'C3848929', 'cui_str': 'empagliflozin 25 MG'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3273807', 'cui_str': 'Gliflozins'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0038766', 'cui_str': 'Sulfonylurea Compounds'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0022658', 'cui_str': 'Kidney Diseases'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}]",,0.203494,"Empagliflozin reduced the risks of incident or worsening nephropathy versus placebo irrespective of use of SU or insulin at baseline (P interaction  >0.05), but there was a greater reduction in this risk for patients not using (HR 0.47","[{'ForeName': 'Silvio E', 'Initials': 'SE', 'LastName': 'Inzucchi', 'Affiliation': 'Section of Endocrinology, Yale University School of Medicine, New Haven, Connecticut, United States.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Fitchett', 'Affiliation': ""St. Michael's Hospital, Division of Cardiology, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Dubravka', 'Initials': 'D', 'LastName': 'Jurišić-Eržen', 'Affiliation': 'Department of Endocrinology and Diabetology, University Hospital Centre, Faculty of Medicine, University of Rijeka, Rijeka, Croatia.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Woo', 'Affiliation': 'Section of Endocrinology and Metabolism, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Hantel', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Janista', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Kaspers', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Jyothis T', 'Initials': 'JT', 'LastName': 'George', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Zinman', 'Affiliation': 'Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Diabetes, obesity & metabolism",['10.1111/dom.13938']
659,31841830,"Effects of web-based concept mapping education on students' concept mapping and critical thinking skills: A double blind, randomized, controlled study.","BACKGROUND


Using concept maps in nurse education improves students' critical thinking skills. Offering web-based concept mapping education can increase motivation for learning in students actively using the Internet.
OBJECTIVES


To examine the effects of web-based concept mapping education on nursing students' concept mapping and critical thinking skills.
DESIGN


This is a double-blind, randomized, controlled, experimental study.
SETTINGS


A nursing faculty at a state university in Turkey.
PARTICIPANTS


Second-year nursing students taking the course surgical nursing in the spring term of the academic year of 2018/2019.
METHODS


The experimental group (n = 201) was offered web-based concept mapping education before starting practicums. Data were collected using a students' information form, concept map evaluation keys, and the Critical Thinking Motivational Scale at the end of the practicums. A structured questionnaire was used to reveal opinions of the students about concept mapping.
RESULTS


There was a significant difference in concept mapping scores between the students offered web-based concept mapping education (16.45 ± 10.91) and those not receiving this education (12.70 ± 9.31) (p= .000). Also, there was a significant difference in students' scores for the subscales of Critical Thinking Motivational Scale expectancy, attainment and utility between the groups. The students reported that concept maps facilitated their learning and management of nursing processes but that they occasionally experienced difficulty.
CONCLUSION


It can be concluded that web-based concept mapping education improves concept mapping skills and motivation for critical thinking skills. Web-based education could be utilized as a tool to enhance nursing students' concept mapping and critical thinking skills.",2020,There was a significant difference in concept mapping scores between the students offered web-based concept mapping education (16.45 ± 10.91) and those not receiving this education (12.70 ± 9.31) (p= .000).,"['A nursing faculty at a state university in Turkey', 'Second-year nursing students taking the course surgical nursing in the spring term of the academic year of 2018/2019', ""students' concept mapping and critical thinking skills""]",['web-based concept mapping education'],"['concept mapping scores', 'Critical Thinking Motivational Scale', 'Critical Thinking Motivational Scale expectancy, attainment and utility']","[{'cui': 'C0015538', 'cui_str': 'Faculty, Nursing'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0041400', 'cui_str': 'Turkey'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0038496', 'cui_str': 'Pupil Nurses'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0038931', 'cui_str': 'Surgical Nursing'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C4279941', 'cui_str': 'Critical Thinking'}]","[{'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4319827', 'cui_str': 'Thought'}, {'cui': 'C0222045'}]",,0.0466569,There was a significant difference in concept mapping scores between the students offered web-based concept mapping education (16.45 ± 10.91) and those not receiving this education (12.70 ± 9.31) (p= .000).,"[{'ForeName': 'Özlem', 'Initials': 'Ö', 'LastName': 'Bilik', 'Affiliation': 'Faculty of Nursing, Dokuz Eylul University, Balcova, Izmir, Turkey.'}, {'ForeName': 'Eda Ayten', 'Initials': 'EA', 'LastName': 'Kankaya', 'Affiliation': 'Faculty of Nursing, Dokuz Eylul University, Balcova, Izmir, Turkey.'}, {'ForeName': 'Zeynep', 'Initials': 'Z', 'LastName': 'Deveci', 'Affiliation': 'Instute of Health Science, Dokuz Eylul University, Izmir, Turkey. Electronic address: zdeveci@pau.edu.tr.'}]",Nurse education today,['10.1016/j.nedt.2019.104312']
660,31848757,"A prospective, randomized controlled study of the safety and efficacy of gasless bilateral axillo-breast approach (BABA) robotic thyroidectomy.","BACKGROUND


During bilateral axillo-breast approach (BABA) robotic thyroidectomy (RoT), carbon dioxide (CO 2 ) gas is insufflated into the operative cavity, not only triggering hemodynamic and metabolic changes, but also inducing postoperative pain and gas embolism. Here, we explored whether the new gasless BABA RoT approach was as safe and efficacious as conventional robotic surgery using CO 2  insufflation.
PATIENTS AND METHODS


We performed a prospective, randomized controlled trial comparing conventional BABA RoT to gasless BABA RoT (CO 2  group, n = 14; gasless group, n = 14). All clinicopathological and oncological outcomes were evaluated. The hemodynamic parameters [heart rate (HR), mean arterial pressure (MAP), cardiac output (CO), and cardiac index (CI)] and metabolic parameters [partial pressure of carbon dioxide (PaCO 2 ) and pH] were measured at baseline; 30, 60, 90, and 120 min after CO 2  insufflation; and 30 min after desufflation. Pain parameters [numeric rating scale (NRS) score, number of analgesics (NA), and bottom hit count (BHC)] were measured at 2, 24, 48, and 72 h after surgery.
RESULTS


We found no statistically significant differences between the two groups in terms of any demographic or baseline characteristic. The clinicopathological and oncological outcomes did not differ significantly between the two groups, but the operation time was longer for the gasless group (187.50 ± 42.64 vs. 212.50 ± 35.88 min; P = 0.028). In terms of the hemodynamic, metabolic, and pain parameters, the pH fell significantly less in the gasless group (P = 0.047), but there were no significant between-group differences in the HR, MAP, CO, CI, PaCO 2,  NRS, NA, or BHC. No safety concerns arose.
CONCLUSION


The new, gasless BABA RoT technique employing the da Vinci robotic surgical system is safe. Although metabolic changes during operation are thereby minimized, gasless BABA RoT should be used carefully when engaging in thyroid surgery; more experience is required.",2020,"The clinicopathological and oncological outcomes did not differ significantly between the two groups, but the operation time was longer for the gasless group (187.50 ± 42.64 vs. 212.50 ± 35.88 min; P = 0.028).","['group, n\u2009=\u200914; gasless group, n\u2009=\u200914']","['conventional BABA RoT to gasless BABA RoT (CO 2', 'gasless bilateral axillo-breast approach (BABA) robotic thyroidectomy', 'new gasless BABA RoT approach', 'bilateral axillo-breast approach (BABA) robotic thyroidectomy (RoT), carbon dioxide (CO 2 ) gas']","['HR, MAP, CO, CI, PaCO 2,  NRS, NA, or BHC', 'hemodynamic parameters [heart rate (HR), mean arterial pressure (MAP), cardiac output (CO), and cardiac index (CI)] and metabolic parameters [partial pressure of carbon dioxide (PaCO 2 ) and pH', 'hemodynamic, metabolic, and pain parameters', 'safety and efficacy', 'operation time', 'Pain parameters [numeric rating scale (NRS) score, number of analgesics (NA), and bottom hit count (BHC']","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0040145', 'cui_str': 'Thyroidectomy'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0596601', 'cui_str': 'Gas'}]","[{'cui': 'C0024779', 'cui_str': 'Map'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0007165', 'cui_str': 'Cardiac Output'}, {'cui': 'C0428776', 'cui_str': 'Cardiac index (observable entity)'}, {'cui': 'C0030604', 'cui_str': 'Partial Pressure'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0596020', 'cui_str': 'Does hit (finding)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}]",,0.0692809,"The clinicopathological and oncological outcomes did not differ significantly between the two groups, but the operation time was longer for the gasless group (187.50 ± 42.64 vs. 212.50 ± 35.88 min; P = 0.028).","[{'ForeName': 'Ik Beom', 'Initials': 'IB', 'LastName': 'Shin', 'Affiliation': 'Department of Surgery, Haeundae Paik Hospital, Inje University College of Medicine, 875 Haeundae-ro, Haeundae-gu, Busan, 612-030, South Korea.'}, {'ForeName': 'Do Hoon', 'Initials': 'DH', 'LastName': 'Koo', 'Affiliation': 'Department of Surgery, Haeundae Paik Hospital, Inje University College of Medicine, 875 Haeundae-ro, Haeundae-gu, Busan, 612-030, South Korea.'}, {'ForeName': 'Myoung Jin', 'Initials': 'MJ', 'LastName': 'Ko', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Haeundae Paik Hospital, Inje University College of Medicine, Busan, South Korea.'}, {'ForeName': 'Se Hoon', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Haeundae Paik Hospital, Inje University College of Medicine, Busan, South Korea.'}, {'ForeName': 'Dong Sik', 'Initials': 'DS', 'LastName': 'Bae', 'Affiliation': 'Department of Surgery, Haeundae Paik Hospital, Inje University College of Medicine, 875 Haeundae-ro, Haeundae-gu, Busan, 612-030, South Korea. md.ds.bae@gmail.com.'}]",Surgical endoscopy,['10.1007/s00464-019-07262-3']
661,31892475,Admitting women in active labour: A randomised controlled trial about the effects of protocol use on childbirth method and interventions.,"AIM


To determine the effects of protocol of admitting women in active labour on childbirth method and interventions during labour and childbirth.
METHODS


This single-blind randomised clinical trial was conducted in a public hospital in Mazandaran province (Iran) in 2017. Two hundred nulliparous low-risk women were randomly assigned into intervention and control groups. The participant women were admitted in the intervention group using the admission protocol and to the group control by staff midwives and doctors. The admission criteria of the protocol were: the presence of regular, painful contractions, the cervix at least four cm dilated and at least one of the following cues: cervix effaced, and spontaneous rupture of membranes, or ""show"". The primary outcome measure was childbirth method. Data were analyzed in SPSS-22 using Mann-Whitney and Chi-square tests. The level of statistical significance was set as p<0.05.
FINDING


There were significant differences between the intervention and control groups in the number of caesarian section (CS) (p<0.001). Two groups had a statistically significant difference in amniotomy (p=0.003), augmentation by oxytocin (p<0.001), number of vaginal examinations (p<0.001) and fundal pressure (p<0.001).
CONCLUSIONS


Using a protocol for admission of low risk nulliparous women in active labour contributed to reduction of the primary caesarean section rate and interventions during childbirth. A risk assessment and using evidence informed guidelines in admission can contribute to reduce unsafe and harmful practices and support normalisation of birth. This is essential for demedicalisation and a useful strategy for reducing primary CS.",2020,"Two groups had a statistically significant difference in amniotomy (p=0.003), augmentation by oxytocin (p<0.001), number of vaginal examinations (p<0.001) and fundal pressure (p<0.001).
","['participant women were admitted in the intervention group using the admission protocol and to the group control by staff midwives and doctors', 'Admitting women in active labour', 'public hospital in Mazandaran province (Iran) in 2017', 'Two hundred nulliparous low-risk women', 'low risk nulliparous women in active labour contributed to reduction of the primary caesarean section rate and interventions during childbirth', 'admitting women in active labour on childbirth method and interventions during labour and childbirth']",[],"['childbirth method', 'augmentation by oxytocin (p<0.001), number of vaginal examinations (p<0.001) and fundal pressure (p<0.001', 'number of caesarian section (CS', 'amniotomy']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0332298', 'cui_str': 'Controlled by (attribute)'}, {'cui': 'C0401993', 'cui_str': 'Staff midwife (occupation)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0233081', 'cui_str': 'Normal labor (finding)'}, {'cui': 'C0020022', 'cui_str': 'Hospitals, Public'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0425979', 'cui_str': 'Nulliparous (finding)'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0007876', 'cui_str': 'C-Section (OB)'}, {'cui': 'C1148523', 'cui_str': 'Childbirth'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}]",[],"[{'cui': 'C1148523', 'cui_str': 'Childbirth'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C1293122', 'cui_str': 'Augmentation procedure'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0200048', 'cui_str': 'Vaginal Exam'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C1384591', 'cui_str': 'Amniotomy'}]",200.0,0.166402,"Two groups had a statistically significant difference in amniotomy (p=0.003), augmentation by oxytocin (p<0.001), number of vaginal examinations (p<0.001) and fundal pressure (p<0.001).
","[{'ForeName': 'Freshteh', 'Initials': 'F', 'LastName': 'Abasian Kasegari', 'Affiliation': 'School of Nursing and Midwifery Shahid Beheshti University of Medical Sciences, Tehran, Iran; Department of Biostatistics, Faculty of Paramedical, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Farzaneh', 'Initials': 'F', 'LastName': 'Pazandeh', 'Affiliation': 'Department of Midwifery and Reproductive Health, Midwifery and Reproductive Health Research Centre, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, Iran; Department of Biostatistics, Faculty of Paramedical, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Electronic address: pazandehf@gmail.com.'}, {'ForeName': 'Soodabeh', 'Initials': 'S', 'LastName': 'Darvish', 'Affiliation': 'School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran; Department of Biostatistics, Faculty of Paramedical, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Reinhard', 'Initials': 'R', 'LastName': 'Huss', 'Affiliation': 'Nuffield Centre for International Health and Development, Leeds Institute of Health Sciences, University of Leeds, Leeds, UK; Department of Biostatistics, Faculty of Paramedical, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Malihe', 'Initials': 'M', 'LastName': 'Nasiri', 'Affiliation': 'School of Nursing and Midwifery Shahid Beheshti University of Medical Sciences, Tehran, Iran; Department of Biostatistics, Faculty of Paramedical, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Women and birth : journal of the Australian College of Midwives,['10.1016/j.wombi.2019.12.002']
662,31886953,Effects of serelaxin in patients admitted for acute heart failure: a meta-analysis.,"AIMS


The effectiveness and safety of 48 h intravenous 30 μg/kg/day serelaxin infusion in acute heart failure (AHF) has been studied in six randomized, controlled clinical trials.
METHODS AND RESULTS


We conducted a fixed-effect meta-analysis including all studies of intravenous serelaxin initiated within the first 16 h of admission for AHF. Endpoints considered were the primary and secondary endpoints examined in the serelaxin phase III studies. In six randomized controlled trials, 6105 total patients were randomized to receive intravenous serelaxin 30 μg/kg/day and 5254 patients to control. Worsening heart failure to day 5 occurred in 6.0% and 8.1% of patients randomized to serelaxin and control, respectively (hazard ratio 0.77, 95% confidence interval 0.67-0.89; P = 0.0002). Serelaxin had no statistically significant effect on length of stay, or cardiovascular death, or heart or renal failure rehospitalization. Serelaxin administration resulted in statistically significant improvement in markers of renal function and reductions in both N-terminal pro-B-type natriuretic peptide and troponin. No significant adverse outcomes were noted with serelaxin. Through the last follow-up, which occurred at an average of 4.5 months (1-6 months), serelaxin administration was associated with a reduction in all-cause mortality, with an estimated hazard ratio of 0.87 (95% confidence interval 0.77-0.98; P = 0.0261).
CONCLUSIONS


Administration of intravenous serelaxin to patients admitted for AHF was associated with a highly significant reduction in the risk of 5-day worsening heart failure and in changes in renal function markers, but not length of stay, or cardiovascular death, or heart or renal failure rehospitalization. Serelaxin administration was safe and associated with a significant reduction in all-cause mortality.",2020,Serelaxin administration resulted in statistically significant improvement in markers of renal function and reductions in both N-terminal pro-B-type natriuretic peptide and troponin.,"['acute heart failure (AHF', 'patients admitted for acute heart failure', '6105 total patients']","['48\u2009h intravenous 30\u2009μg/kg/day serelaxin infusion', 'Serelaxin', 'serelaxin', 'intravenous serelaxin']","['markers of renal function and reductions in both N-terminal pro-B-type natriuretic peptide and troponin', 'length of stay, or cardiovascular death, or heart or renal failure rehospitalization', 'Worsening heart failure', 'effectiveness and safety', 'adverse outcomes']","[{'cui': 'C0264714', 'cui_str': 'Acute heart failure (disorder)'}, {'cui': 'C0015506', 'cui_str': 'coagulation factor VIII'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0439418', 'cui_str': 'kg/day'}, {'cui': 'C3700393'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}]","[{'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0754710', 'cui_str': 'Amino-terminal pro-brain natriuretic peptide'}, {'cui': 'C0523952', 'cui_str': 'Troponin measurement'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0035078', 'cui_str': 'Kidney Failure'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.234191,Serelaxin administration resulted in statistically significant improvement in markers of renal function and reductions in both N-terminal pro-B-type natriuretic peptide and troponin.,"[{'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Teerlink', 'Affiliation': 'Section of Cardiology, San Francisco Veterans Affairs Medical Center and School of Medicine, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Beth A', 'Initials': 'BA', 'LastName': 'Davison', 'Affiliation': 'Momentum Research, Inc., Durham, NC, USA.'}, {'ForeName': 'Gad', 'Initials': 'G', 'LastName': 'Cotter', 'Affiliation': 'Momentum Research, Inc., Durham, NC, USA.'}, {'ForeName': 'Aldo P', 'Initials': 'AP', 'LastName': 'Maggioni', 'Affiliation': 'Italian Association of Hospital Cardiologists (ANMCO) Research Center, Florence, Italy.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Sato', 'Affiliation': 'Cardiology and Intensive Care Unit, Nippon Medical School, Musashi-Kosugi Hospital, Kawasaki, Japan.'}, {'ForeName': 'Ovidiu', 'Initials': 'O', 'LastName': 'Chioncel', 'Affiliation': 'University of Medicine Carol Davila, Bucharest, Romania.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Ertl', 'Affiliation': 'Julius-Maximilians-Universität Würzburg, Würzburg, Germany.'}, {'ForeName': 'G Michael', 'Initials': 'GM', 'LastName': 'Felker', 'Affiliation': 'Division of Cardiology, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Gerasimos', 'Initials': 'G', 'LastName': 'Filippatos', 'Affiliation': 'Athens University Hospital Attikon, Athens, Greece.'}, {'ForeName': 'Barry H', 'Initials': 'BH', 'LastName': 'Greenberg', 'Affiliation': 'Division of Cardiology, University of California, San Diego, CA, USA.'}, {'ForeName': 'Peter S', 'Initials': 'PS', 'LastName': 'Pang', 'Affiliation': 'Department of Emergency Medicine, Indiana University School of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Ponikowski', 'Affiliation': 'Department of Heart Diseases, Medical University, Military Hospital, Wroclaw, Poland.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Edwards', 'Affiliation': 'Momentum Research, Inc., Durham, NC, USA.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Senger', 'Affiliation': 'Momentum Research, Inc., Durham, NC, USA.'}, {'ForeName': 'Sam L', 'Initials': 'SL', 'LastName': 'Teichman', 'Affiliation': 'Formerly Corthera, San Carlos, CA, USA.'}, {'ForeName': 'Olav Wendelboe', 'Initials': 'OW', 'LastName': 'Nielsen', 'Affiliation': 'Department of Cardiology, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Adriaan A', 'Initials': 'AA', 'LastName': 'Voors', 'Affiliation': 'University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Metra', 'Affiliation': 'Department of Medical and Surgical Specialties, Radiological Sciences, and Public Health, University of Brescia, Brescia, Italy.'}]",European journal of heart failure,['10.1002/ejhf.1692']
663,31735618,"Effects of Alcohol Administered With Flibanserin in Healthy Premenopausal Women: A Randomized, Double-Blind, Single-Dose Crossover Study.","INTRODUCTION


Flibanserin is approved in the United States and Canada for the treatment of hypoactive sexual desire disorder in premenopausal women.
AIM


The purpose of this trial was to evaluate the safety of concomitant administration of flibanserin with alcohol.
METHODS


In this single-center, randomized, double-blind, single-dose, crossover study, participants were randomly assigned to 1 of 12 sequences to receive each of 7 treatments: flibanserin 100 mg or placebo with ethanol 0.2 g/kg, 0.4 g/kg, or 0.6 g/kg, or flibanserin 100 mg only. Treatments were administered using a worst-case approach that included morning dosing and consumption of alcohol within 10 minutes.
MAIN OUTCOME MEASURE


The primary end point was the proportion of participants who experienced dizziness, syncope, or hypotension. Safety end points included orthostatic vital signs.
RESULTS


The study included 96 premenopausal women (mean age 31 ± 8 years). The incidence of dizziness for ethanol + flibanserin was 39.8% for ethanol 0.6 g/kg, 34.1% for 0.4 g/kg, and 27.4% for 0.2 g/kg compared with 31.1% for flibanserin without ethanol. Based on the available vital signs data, there was no effect of ethanol concentration on orthostatic blood pressure, vertigo, or hypotension; no instances of syncope were observed. The overall incidence of adverse events (AEs) was similar when flibanserin was administered alone (96.7%) or with ethanol (90.5-97.6%).
CLINICAL IMPLICATIONS


Consumption of the tested amounts of alcohol (0.2-0.6 g/kg) does not have an additive effect on the AE profile of flibanserin 100 mg in healthy premenopausal women.
STRENGTHS & LIMITATIONS


Strengths include the study population (premenopausal women, as indicated for flibanserin) and range of ethanol doses. Limitations include the morning dosing of study medication, which is inconsistent with the bedtime dosing recommended for flibanserin, and the method of handling missing vital sign measurements.
CONCLUSION


Co-administration of flibanserin 100 mg with varying doses of ethanol resulted in few AEs of special interest, with no notable alcohol dose response. However, a significantly greater percentage of participants administered flibanserin with 0.6 g/kg and 0.4 g/kg of alcohol were characterized as ""Participants in Whom Standing Blood Pressure Was Not Obtained"" compared with participants administered flibanserin alone. Simon JA, Clayton AH, Parish SJ, et al. Effects of Alcohol Administered With Flibanserin in Healthy Premenopausal Women: A Randomized, Double-Blind, Single-Dose Crossover Study. J Sex Med 2020;17:83-93.",2020,"The incidence of dizziness for ethanol + flibanserin was 39.8% for ethanol 0.6 g/kg, 34.1% for 0.4 g/kg, and 27.4% for 0.2 g/kg compared with 31.1% for flibanserin without ethanol.","['study population (premenopausal women, as indicated for flibanserin) and range of ethanol doses', '96 premenopausal women (mean age 31 ± 8 years', 'Healthy Premenopausal Women', 'hypoactive sexual desire disorder in premenopausal women', 'healthy premenopausal women']","['flibanserin 100 mg only', 'ethanol', 'flibanserin', 'Alcohol Administered With Flibanserin', 'flibanserin with alcohol', 'flibanserin 100 mg or placebo with ethanol', 'Flibanserin']","['orthostatic blood pressure, vertigo, or hypotension; no instances of syncope', 'proportion of participants who experienced dizziness, syncope, or hypotension', 'orthostatic vital signs', 'incidence of dizziness for ethanol\xa0+ flibanserin', 'overall incidence of adverse events (AEs']","[{'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0754280', 'cui_str': 'flibanserin'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0202304', 'cui_str': 'Alcohol measurement (procedure)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0020594', 'cui_str': 'Hypoactive Sexual Desire Disorder'}]","[{'cui': 'C4051422', 'cui_str': 'flibanserin 100 MG [Addyi]'}, {'cui': 'C0202304', 'cui_str': 'Alcohol measurement (procedure)'}, {'cui': 'C0754280', 'cui_str': 'flibanserin'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0042571', 'cui_str': 'Spinning Sensation'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0039070', 'cui_str': 'Fainting'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0518766'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0202304', 'cui_str': 'Alcohol measurement (procedure)'}, {'cui': 'C0754280', 'cui_str': 'flibanserin'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.521132,"The incidence of dizziness for ethanol + flibanserin was 39.8% for ethanol 0.6 g/kg, 34.1% for 0.4 g/kg, and 27.4% for 0.2 g/kg compared with 31.1% for flibanserin without ethanol.","[{'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Simon', 'Affiliation': 'George Washington University, Washington, DC, USA. Electronic address: jsimon@jamesasimonmd.com.'}, {'ForeName': 'Anita H', 'Initials': 'AH', 'LastName': 'Clayton', 'Affiliation': 'University of Virginia School of Medicine, Charlottesville, Virginia, USA.'}, {'ForeName': 'Sharon J', 'Initials': 'SJ', 'LastName': 'Parish', 'Affiliation': 'Weill Cornell Medical College, New York, New York, USA.'}, {'ForeName': 'Stuart C', 'Initials': 'SC', 'LastName': 'Apfel', 'Affiliation': 'Albert Einstein College of Medicine, Yeshiva University, New York, New York, USA.'}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Millheiser', 'Affiliation': 'Stanford University School of Medicine, Stanford, California, USA.'}]",The journal of sexual medicine,['10.1016/j.jsxm.2019.10.004']
664,31833464,Effectiveness of a primary care-based group educational intervention in the management of patients with migraine: a randomized controlled trial.,"AIM


The aim of this study was to assess the effectiveness of a primary care-based group educational intervention about concepts of pain neuroscience for the management of migraine compared to the routine medical care delivered to patients with this condition.
BACKGROUND


The way pain is understood has been radically changed in recent decades, thanks to developments in the field of neuroscience. Thus, migraine may develop as a result of an exaggerated perception of threat that activates the pain neuromatrix, which might be modifiable, from a learning perspective, by adjusting the beliefs and behaviours that favour the onset of an attack.
METHODS


A randomised controlled trial was carried out in five primary care health centres of Vitoria-Gasteiz (Basque Country, Spain). The follow-up period was 12 months. The main outcome measure was the reduction in days lost due to migraine-related disability according to the Migraine Disability Assessment Test (MIDAS) score. Secondary outcome measures included the intensity and frequency of the pain and the number of analgesic drugs taken in the previous three months. A positive response to treatment was considered when the MIDAS score decreased by at least 50% from baseline.
FINDINGS


Days lost due to migraine-related disability decreased by at least 50% in 68.9% (n = 37) of patients in the intervention group and 34.6% of patients in the control group (n = 18) (P < 0.001). The intensity of the headache [odds ratio (OR) 9.116; P = 0.005] and the medication intake (OR 13.267; P < 0.001) were also significantly reduced with the intervention.
CONCLUSIONS


The provision of suitable information through a group educational intervention delivered in primary care appears to be effective in preventing migraine attacks. Moreover, the intervention could offer a new cost-effective management alternative that seems to reduce the need for pharmacological treatment in patients with migraine.",2019,The main outcome measure was the reduction in days lost due to migraine-related disability according to the Migraine Disability Assessment Test (MIDAS) score.,"['patients with this condition', 'patients with migraine', 'five primary care health centres of Vitoria-Gasteiz (Basque Country, Spain']",['primary care-based group educational intervention'],"['migraine-related disability', 'intensity and frequency of the pain and the number of analgesic drugs taken', 'intensity of the headache', 'MIDAS score', 'reduction in days lost due to migraine-related disability according to the Migraine Disability Assessment Test (MIDAS) score', 'medication intake']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0475309', 'cui_str': 'Health center (environment)'}, {'cui': 'C0337796', 'cui_str': 'Basques (ethnic group)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0037747', 'cui_str': 'Spain'}]","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C4720892', 'cui_str': 'Migraine disability assessment test'}]",,0.03418,The main outcome measure was the reduction in days lost due to migraine-related disability according to the Migraine Disability Assessment Test (MIDAS) score.,"[{'ForeName': 'Iñaki', 'Initials': 'I', 'LastName': 'Aguirrezabal', 'Affiliation': 'San Martín Health Centre, Integrated Health Organization Araba (Primary Care), Álava, Spain.'}, {'ForeName': 'Maria Soledad', 'Initials': 'MS', 'LastName': 'Pérez de San Román', 'Affiliation': 'Aranbizkarra II Health Centre, Integrated Health Organization Araba (Primary Care), Álava, Spain.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Cobos-Campos', 'Affiliation': 'Methodology and Statistics Unit, Bioaraba Health Research Institute, Araba University Hospital, Álava, Spain.'}, {'ForeName': 'Estibalitz', 'Initials': 'E', 'LastName': 'Orruño', 'Affiliation': 'Methodology and Statistics Unit, Bioaraba Health Research Institute, Araba University Hospital, Álava, Spain.'}, {'ForeName': 'Arturo', 'Initials': 'A', 'LastName': 'Goicoechea', 'Affiliation': 'Araba University Hospital (Santiago Headquarters), Integrated Health Organization Araba, Álava, Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Martínez de la Eranueva', 'Affiliation': 'Multidisciplinary Teaching Unit of Araba, Integrated Health Organization Araba, Álava, Spain.'}, {'ForeName': 'Mercedes', 'Initials': 'M', 'LastName': 'Arroniz', 'Affiliation': 'San Martín Health Centre, Integrated Health Organization Araba (Primary Care), Álava, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Uzquiza', 'Affiliation': 'Labastida Health Centre, Integrated Health Organization Araba (Primary Care), Álava, Spain.'}]",Primary health care research & development,['10.1017/S1463423619000720']
665,31789451,Persistent whole day meal effects of three dipeptidyl peptidase-4 inhibitors on glycaemia and hormonal responses in metformin-treated type 2 diabetes.,"AIM


Dipeptidyl peptidase-4 (DPP-4) inhibition has effects on both fasting and postprandial glucose. However, the extent of this effect over the whole day and whether different DPP-4 inhibitors have the same effects have not been established. We therefore explored the whole day effects of three different DPP-4 inhibitors versus placebo on glucose, islet and incretin hormones after ingestion of breakfast, lunch and dinner in subjects with metformin-treated and well-controlled type 2 diabetes.
METHODS


The study was single-centre and crossover designed, involving 24 subjects [12 men, 12 women, mean age 63 years, body mass index 31.0 kg/m 2  , glycated haemoglobin 44.7 mmol/mol (6.2%)], who underwent four test days in random order. Each whole day test included ingestion of standardized breakfast (525 kcal), lunch (780 kcal) and dinner (560 kcal) after intake of sitagliptin (100 mg) or vildagliptin (50 mg twice), or saxagliptin (5 mg) or placebo.
RESULTS


Compared with placebo, DPP-4 inhibition reduced glucose levels, increased beta-cell function (insulin secretory rate in relation to glucose), suppressed glucagon, increased intact glucagon-like-peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) but suppressed total GLP-1 and GIP after all three meals. The effects were sustained throughout the daytime period with similar changes after each meal and did not differ between the DPP-4 inhibitors.
CONCLUSIONS


DPP-4 inhibition has persistent daytime effects on glucose, islet and incretin hormones with no difference between three different DPP-4 inhibitors.",2020,"Compared to placebo, DPP-4 inhibition reduced glucose levels, increased beta-cell function (insulin secretory rate in relation to glucose), suppressed glucagon, increased intact GLP-1 and GIP but suppressed total GLP-1 and GIP after all three meals.","['subjects with metformin-treated and well-controlled type 2 diabetes', 'metformin-treated type 2 diabetes', 'twenty-four subjects (twelve males, twelve females, mean age 63 yrs, BMI 31.0 kg/m 2  , HbA1c 44.7\u2009mmol/mol\xa0=\xa06.2%), who underwent four test days in random order']","['saxagliptin', 'sitagliptin (100mg), vildagliptin', 'placebo', 'dipeptidyl peptidase-4 inhibitors', 'DPP-4 inhibitors versus placebo']","['glycemia and hormonal responses', 'beta-cell function (insulin secretory rate in relation to glucose), suppressed glucagon, increased intact GLP-1 and GIP but suppressed total GLP-1 and GIP', 'ingestion of standardized breakfast (525kcal), lunch (780kcal), and dinner (560kcal', 'glucose levels']","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C3853142', 'cui_str': 'Well controlled'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}, {'cui': 'C4517820', 'cui_str': '6.2'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}]","[{'cui': 'C1611934', 'cui_str': 'saxagliptin'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C1570906', 'cui_str': 'vildagliptin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1827106', 'cui_str': 'Dipeptidyl-Peptidase 4 Inhibitors'}, {'cui': 'C0058353', 'cui_str': 'DPPS'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0458083', 'cui_str': 'Hormonal (qualifier value)'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0036542', 'cui_str': 'Secretory Rate'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C1260953', 'cui_str': 'Suppressed (qualifier value)'}, {'cui': 'C0876232', 'cui_str': 'glucagon recombinant'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0205266', 'cui_str': 'Intact (qualifier value)'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C1702020', 'cui_str': '37-epsilon-palmitoyl-Lys-GIP'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C4553621', 'cui_str': 'With breakfast'}, {'cui': 'C4552032', 'cui_str': 'With lunch'}, {'cui': 'C4552592', 'cui_str': 'With dinner'}, {'cui': 'C0428548', 'cui_str': 'Glucose level - finding'}]",24.0,0.0895207,"Compared to placebo, DPP-4 inhibition reduced glucose levels, increased beta-cell function (insulin secretory rate in relation to glucose), suppressed glucagon, increased intact GLP-1 and GIP but suppressed total GLP-1 and GIP after all three meals.","[{'ForeName': 'Wathik', 'Initials': 'W', 'LastName': 'Alsalim', 'Affiliation': 'Department of Clinical Sciences Lund, Lund University, Lund, Sweden.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Göransson', 'Affiliation': 'Department of Experimental Medical Science, Lund University, Lund, Sweden.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Tura', 'Affiliation': 'CNR Institute of Neuroscience, Padova, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Pacini', 'Affiliation': 'CNR Institute of Neuroscience, Padova, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Mari', 'Affiliation': 'CNR Institute of Neuroscience, Padova, Italy.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Ahrén', 'Affiliation': 'Department of Clinical Sciences Lund, Lund University, Lund, Sweden.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13934']
666,31328399,Unconditional and conditional monetary incentives to increase response to mailed questionnaires: A randomized controlled study within a trial (SWAT).,"RATIONALE, AIMS, AND OBJECTIVES


High response rates to research questionnaires can help to ensure results are more representative of the population studied and provide increased statistical power, on which the study may have been predicated. Improving speed and quality of response can reduce costs.
METHOD


We conducted a randomized study within a trial (SWAT) to assess questionnaire response rates, reminders sent, and data completeness with unconditional compared with conditional monetary incentives. Eligible individuals were mailed a series of psychological questionnaires as a follow-up to a baseline host trial questionnaire. Half received a £5 gift voucher with questionnaires (unconditional), and half were promised the voucher after returning questionnaires (conditional).
RESULTS


Of 1079 individuals, response rates to the first follow-up questionnaire were 94.2% and 91.7% in the unconditional and conditional monetary incentive groups, respectively (OR 1.78; 95% CI, 0.85-3.72). There were significantly greater odds of returning repeat questionnaires in the unconditional group at 6 months (OR 2.97; 95% CI, 1.01-8.71; .047) but not at 12 months (OR 1.12; 95% CI, 0.44-2.85). Incentive condition had no impact at any time point on the proportion of sent questionnaires that needed reminders. Odds of incomplete questionnaires were significantly greater at 3 months in the unconditional compared with the conditional incentive group (OR 2.45; 95% CI, 1.32-4.55; .004).
CONCLUSIONS


Unconditional monetary incentives can produce a transitory greater likelihood of mailed questionnaire response in a clinical trial participant group, consistent with the direction of effect in other settings. However, this could have been a chance finding. The use of multiple strategies to promote response may have created a ceiling effect. This strategy has potential to reduce administrative and postage costs, weighed against the cost of incentives used, but could risk compromising the completeness of data.",2020,"Odds of incomplete questionnaires were significantly greater at 3 months in the unconditional compared with the conditional incentive group (OR 2.45; 95% CI, 1.32-4.55; .004).
","['mailed questionnaires', '1079 individuals']",[],"['odds of returning repeat questionnaires', 'Odds of incomplete questionnaires', 'response rates to the first follow-up questionnaire']","[{'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]",[],"[{'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205257', 'cui_str': 'Incomplete (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]",1079.0,0.048489,"Odds of incomplete questionnaires were significantly greater at 3 months in the unconditional compared with the conditional incentive group (OR 2.45; 95% CI, 1.32-4.55; .004).
","[{'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Young', 'Affiliation': 'Division of Primary Care, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Bedford', 'Affiliation': 'Division of Primary Care, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Roshan', 'Initials': 'R', 'LastName': 'das Nair', 'Affiliation': 'Division of Psychiatry and Applied Psychology, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Gallant', 'Affiliation': 'Tayside Clinical Trials Unit, University of Dundee, Dundee, UK.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Littleford', 'Affiliation': 'Tayside Clinical Trials Unit, University of Dundee, Dundee, UK.'}, {'ForeName': 'John F R', 'Initials': 'JFR', 'LastName': 'Robertson', 'Affiliation': 'Division of Medical Sciences and Graduate Entry Medicine, University of Nottingham, Derby, UK.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Schembri', 'Affiliation': 'Respiratory Department, Ninewells Hospital, Dundee, UK.'}, {'ForeName': 'Frank M', 'Initials': 'FM', 'LastName': 'Sullivan', 'Affiliation': 'School of Medicine, University of St Andrews, St Andrews, UK.'}, {'ForeName': 'Kavita', 'Initials': 'K', 'LastName': 'Vedhara', 'Affiliation': 'Division of Primary Care, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Kendrick', 'Affiliation': 'Division of Primary Care, University of Nottingham, Nottingham, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of evaluation in clinical practice,['10.1111/jep.13230']
667,31332902,Cortical thickness increases with levomilnacipran treatment in a pilot randomised double-blind placebo-controlled trial in late-life depression.,"BACKGROUND


Late-life depression (LLD) is associated with significant medical comorbidity, cognitive impairment, and suboptimal treatment response compared to depression experienced earlier in life. Levomilnacipran (LVM) is a novel antidepressant the effects of which on neuroplasticity have not yet been investigated. We investigated the effect of LVM on cortical thickness in a pilot randomised placebo-controlled trial in LLD.
METHODS


Twenty-nine adults (≥ 60 years) with major depression (48.3% female; mean age = 71.5 ± 5.8 years; mean education = 16.0 ± 1.7 years) were randomised to either LVM or placebo for 12 weeks. T1-weighted images were acquired at baseline and 12 weeks. Thirteen subjects (six LVM and seven placebo) completed the study. Group differences in cortical thickness change across the study period were evaluated, with age and total intracranial volume included as covariates.
RESULTS


Dropout rates did not differ significantly between groups. The LVM group had significantly more side effects, but no serious adverse events were reported. Lower LVM dose (≤ 40 mg) was better tolerated than higher doses (80-120 mg). Additionally, the LVM group showed a larger increase in cortical thickness in the right postcentral gyrus (primary somatosensory), supramarginal gyrus (sensory association region), and lateral occipital cortex (visual cortex) compared to the placebo group and greater reductions in the left insula.
CONCLUSIONS


LVM may be less tolerable by older adults with depression and the effects on cortical thickness across sensory and sensory association regions may be related to the experience of side effects. Larger studies are necessary to evaluate treatment efficacy, tolerability, and neural effects of LVM in LLD.",2020,"Additionally, the LVM group showed a larger increase in cortical thickness in the right postcentral gyrus (primary somatosensory), supramarginal gyrus (sensory association region), and lateral occipital cortex (visual cortex) compared to the placebo group and greater reductions in the left insula.
","['Twenty-nine adults (≥ 60 years) with major depression (48.3% female; mean age = 71.5\u2009±\u20095.8\u2009years; mean education = 16.0\u2009±\u20091.7\u2009years', 'Thirteen subjects (six LVM and seven', 'older adults with depression', 'late-life depression']","['LVM', 'placebo', 'LVM or placebo', 'Levomilnacipran (LVM', 'levomilnacipran']","['serious adverse events', 'Cortical thickness', 'right postcentral gyrus (primary somatosensory), supramarginal gyrus (sensory association region), and lateral occipital cortex (visual cortex', 'cortical thickness', 'cortical thickness change', 'side effects']","[{'cui': 'C0450351', 'cui_str': '29 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517796', 'cui_str': '5.8'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C4517512', 'cui_str': '1.7 (qualifier value)'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3541367', 'cui_str': 'levomilnacipran'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0152302', 'cui_str': 'Gyrus Postcentralis'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0228214', 'cui_str': 'Supramarginal Gyrus'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C3811911', 'cui_str': 'Cuneus'}, {'cui': 'C0042817', 'cui_str': 'Visual Cortex'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",29.0,0.45761,"Additionally, the LVM group showed a larger increase in cortical thickness in the right postcentral gyrus (primary somatosensory), supramarginal gyrus (sensory association region), and lateral occipital cortex (visual cortex) compared to the placebo group and greater reductions in the left insula.
","[{'ForeName': 'Beatrix', 'Initials': 'B', 'LastName': 'Krause-Sorio', 'Affiliation': 'Department of Psychiatry, Semel Institute for Neuroscience, University of California Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Kilpatrick', 'Affiliation': 'Department of Psychiatry, Semel Institute for Neuroscience, University of California Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Prabha', 'Initials': 'P', 'LastName': 'Siddarth', 'Affiliation': 'Department of Psychiatry, Semel Institute for Neuroscience, University of California Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Ercoli', 'Affiliation': 'Department of Psychiatry, Semel Institute for Neuroscience, University of California Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Kelsey T', 'Initials': 'KT', 'LastName': 'Laird', 'Affiliation': 'Department of Psychiatry, Semel Institute for Neuroscience, University of California Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Yesenia', 'Initials': 'Y', 'LastName': 'Aguilar-Faustino', 'Affiliation': 'Department of Psychiatry, Semel Institute for Neuroscience, University of California Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Michaela M', 'Initials': 'MM', 'LastName': 'Milillo', 'Affiliation': 'Department of Psychiatry, Semel Institute for Neuroscience, University of California Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Katherine L', 'Initials': 'KL', 'LastName': 'Narr', 'Affiliation': 'Department of Psychiatry, Semel Institute for Neuroscience, University of California Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Lavretsky', 'Affiliation': 'Department of Psychiatry, Semel Institute for Neuroscience, University of California Los Angeles, Los Angeles, California, USA.'}]",Psychogeriatrics : the official journal of the Japanese Psychogeriatric Society,['10.1111/psyg.12475']
668,31338807,Peripheral electrical stimulation reduces postoperative hypoxemia in patients at risk for obstructive sleep apnea: a randomized-controlled trial.,"PURPOSE


Severity of hypoxemic events resulting from obstructive sleep apnea (OSA) is correlated with increased risk of complications and sudden death. We studied the use of a peripheral transcutaneous electrical stimulus (TES) on the magnitude and duration of sleep apnea associated hypoxemia in postoperative patients at high risk for OSA.
METHODS


In this randomized, double-blind, controlled, single-centre trial, 106 adult patients undergoing elective surgery who were at medium to high risk for OSA (sleep apnea clinical scores of 18-35) were randomized to either TES (active stimulus group, n = 53) or control (non-stimulus group, n = 53) during their stay in the postanesthesia care unit. Transcutaneous electrical stimuli were delivered at threshold oxygen saturation measurements (SpO 2 ) ≤ 93%. The primary endpoint was the SpO 2  area under the curve (AUC) < 90%. Secondary endpoints included the percentage of patients with SpO 2  < 90%, duration SpO 2  < 90%, lowest SpO 2  in the first hour, and adverse events associated with TES.
RESULTS


Compared with controls (n = 45), those in the active group (n = 34) showed a decreased SpO 2  AUC < 90% (median 0.0 vs 15.2 % sec, respectively; P = 0.009), a smaller percentage of subjects with SpO 2  < 90% (47% active vs 71% control; P = 0.03), a shorter duration of SpO 2  < 90% (median 0.0 vs 19.1 sec, respectively; P = 0.01), and a higher nadir of SpO 2  recorded during the first hour (median 90.5% vs 87.9%, respectively; P = 0.04). Among patients with at least one SpO 2  < 93%, there were fewer with SpO 2  < 90% in the active group (55% vs 84%, respectively; P = 0.009). No adverse events related to TES were reported.
CONCLUSION


In postoperative surgical patients at risk for OSA, peripheral transcutaneous electrical stimulation applied during apneic episodes decreased the duration and magnitude of hypoxemia.
TRIAL REGISTRATION


www.ClinicalTrials.gov (NCT02554110); registered 18 September, 2015.",2019,"Compared with controls (n = 45), those in the active group (n = 34) showed a decreased SpO 2  AUC < 90% (median 0.0 vs 15.2 % sec, respectively; P = 0.009), a smaller percentage of subjects with SpO 2  < 90% (47% active vs 71% control; P = 0.03), a shorter duration of SpO 2  < 90% (median 0.0 vs 19.1 sec, respectively; P = 0.01), and a higher nadir of SpO 2  recorded during the first hour (median 90.5% vs 87.9%, respectively; P = 0.04).","['patients at risk for obstructive sleep apnea', 'obstructive sleep apnea (OSA', '106 adult patients undergoing elective surgery who were at medium to high risk for OSA (sleep apnea clinical scores of 18-35', 'postoperative patients at high risk for OSA.\nMETHODS']","['TES (active stimulus group, n = 53) or control (non-stimulus group, n = 53) during their stay in the postanesthesia care unit', 'peripheral transcutaneous electrical stimulus (TES', 'Peripheral electrical stimulation']","['SpO 2  area under the curve (AUC', 'postoperative hypoxemia', 'percentage of patients with SpO 2  < 90%, duration SpO']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0206058', 'cui_str': 'Elective Surgical Procedures'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0037315', 'cui_str': 'Sleep Hypopnea'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0234402', 'cui_str': 'Stimulus, function (observable entity)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0262723', 'cui_str': 'Postanesthesia care (regime/therapy)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0442828', 'cui_str': 'Electrical (qualifier value)'}, {'cui': 'C0013786', 'cui_str': 'Electrical Stimulation'}]","[{'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439087', 'cui_str': '<90 (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]",106.0,0.0991238,"Compared with controls (n = 45), those in the active group (n = 34) showed a decreased SpO 2  AUC < 90% (median 0.0 vs 15.2 % sec, respectively; P = 0.009), a smaller percentage of subjects with SpO 2  < 90% (47% active vs 71% control; P = 0.03), a shorter duration of SpO 2  < 90% (median 0.0 vs 19.1 sec, respectively; P = 0.01), and a higher nadir of SpO 2  recorded during the first hour (median 90.5% vs 87.9%, respectively; P = 0.04).","[{'ForeName': 'Hugh M', 'Initials': 'HM', 'LastName': 'Smith', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, 200 First Street, SW, Rochester, MN, 55905, USA. Smith.Hugh2@Mayo.edu.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Kilger', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, 200 First Street, SW, Rochester, MN, 55905, USA.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Burkle', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, 200 First Street, SW, Rochester, MN, 55905, USA.'}, {'ForeName': 'Darrell R', 'Initials': 'DR', 'LastName': 'Schroeder', 'Affiliation': 'Department of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Bhargavi', 'Initials': 'B', 'LastName': 'Gali', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, 200 First Street, SW, Rochester, MN, 55905, USA.'}]",Canadian journal of anaesthesia = Journal canadien d'anesthesie,['10.1007/s12630-019-01451-3']
669,31283053,The influence of oxytocin on risk-taking in the balloon analogue risk task among women with bulimia nervosa and binge eating disorder.,"Previous theoretical models of bulimia nervosa (BN) and binge eating disorder (BED) have implicated cross-domain risk-taking behaviour as a significant maintenance factor in both disorders. The present study aimed to test this hypothesis by administering the Balloon Analogue Risk Task (BART) to 25 women with BN or BED and 27 healthy comparison women without a history of an eating disorder. Furthermore, we tested the effect of a divided dose of 64 IU of oxytocin on risk-taking behaviour in the BART. Contrary to our hypothesis, women with BN or BED did not exhibit baseline differences in performance on the BART in the placebo condition (t = 1.42, df = 50, P = 0.161, d = 0.39). Oxytocin did not have a main effect on performance in the BART (F = 0.01, df = 1, P = .907, η 2   partial   < 0.001); however, there was an interaction, such that participants in the BN/BED participant group, compared to the healthy comparison group, demonstrated safer behaviour on the BART in the oxytocin condition, but not in the placebo condition (F = 4.29, df = 1, P = 0.044, η 2   partial   = 0.082). These findings cast doubt on the common assumption that individuals with BN and BED exhibit greater risk-taking behaviour in all domains and add to the evidence that oxytocin plays a functional role in modulating behaviours that entail trade-offs between reward approach and risk in humans. We recommend that future dose-response studies investigate the effect of oxytocin on reward approach behaviour further in women with recurrent binge eating behaviour, as well as the clinical significance of this effect.",2019,"Oxytocin did not have a main effect on performance in the BART (F = 0.01, df = 1, p = .907, η 2   partial  < .001); however, there was an interaction such that participants in the BN/BED participant group, compared to the healthy comparison group, demonstrated safer behaviour on the BART specifically in the oxytocin condition, but not in the placebo condition (F = 4.29, df = 1, p = .044, η 2   partial  = .082).","['Women with Bulimia Nervosa and Binge Eating Disorder', '25 women with BN or BED and 27 healthy comparison women without history of an eating disorder', 'women with recurrent binge eating behaviour', 'bulimia nervosa (BN) and binge eating disorder (BED']","['64IU oxytocin', 'oxytocin', 'Oxytocin', 'Balloon Analogue Risk Task (BART']","['Risk-Taking in the Balloon Analogue Risk Task', 'risk-taking behaviour', 'safer behaviour']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2267227', 'cui_str': 'Bulimia Nervosa'}, {'cui': 'C0596170', 'cui_str': 'Binge overeating'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0004916', 'cui_str': 'Beds'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0013473', 'cui_str': 'Eating Disorders'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft (physical object)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]","[{'cui': 'C0035651', 'cui_str': 'Risk-Taking'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft (physical object)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",25.0,0.122906,"Oxytocin did not have a main effect on performance in the BART (F = 0.01, df = 1, p = .907, η 2   partial  < .001); however, there was an interaction such that participants in the BN/BED participant group, compared to the healthy comparison group, demonstrated safer behaviour on the BART specifically in the oxytocin condition, but not in the placebo condition (F = 4.29, df = 1, p = .044, η 2   partial  = .082).","[{'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Leslie', 'Affiliation': ""King's College London (KCL), Institute of Psychiatry, Psychology and Neuroscience (IoPPN), London, UK.""}, {'ForeName': 'Jenni', 'Initials': 'J', 'LastName': 'Leppanen', 'Affiliation': ""King's College London (KCL), Institute of Psychiatry, Psychology and Neuroscience (IoPPN), London, UK.""}, {'ForeName': 'Yannis', 'Initials': 'Y', 'LastName': 'Paloyelis', 'Affiliation': ""King's College London (KCL), Institute of Psychiatry, Psychology and Neuroscience (IoPPN), London, UK.""}, {'ForeName': 'Bruno Palazzo', 'Initials': 'BP', 'LastName': 'Nazar', 'Affiliation': ""King's College London (KCL), Institute of Psychiatry, Psychology and Neuroscience (IoPPN), London, UK.""}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Treasure', 'Affiliation': ""King's College London (KCL), Institute of Psychiatry, Psychology and Neuroscience (IoPPN), London, UK.""}]",Journal of neuroendocrinology,['10.1111/jne.12771']
670,32491941,Effect of computer-assisted-learning and simulation clinics on dental students' cognitive and performance skills: panoramic image errors related to patient's head position.,"OBJECTIVES


To assess dental students' ability to recognize head positioning errors in panoramic (PAN) images after individual learning via computer-assisted-learning (CAL) and in a simulation clinic (SIM). Both cognitive skills and performance in patient examination were assessed.
METHODS AND MATERIALS


60 students (mean age 23.25 years) participated in lectures on the relation between PAN-image errors and patient's head position. Immediately after they took a test, based on which they were randomized to three groups: control (CON) group, CAL group, and SIM group (both CAL and training in a simulation clinic with a phantom). 4-5 weeks after intervention/no intervention, all students individually examined a patient with PAN-exposure. A blinded rater, not knowing group allocation, supervised patient exposure and assessed student's performance (correct/incorrect head position in three planes). 1-2 weeks after, the students scored positioning errors in 40 PAN-images. Differences in cognitive test scores between groups were evaluated by ANOVA and in patient examination by χ 2  tests, and within-group differences by sign-tests.
RESULTS


No statistically significant difference in cognitive test scores was seen between the SIM and CAL group, while the CON group scored lower ( p  < 0.003). In all groups, several students positioned the patient incorrectly in the Frankfort horizontal plane. All students performed well in the sagittal plane. Students in SIM group positioned the patient more correctly in the coronal plane.
CONCLUSIONS


Training with CAL increased students' cognitive skills compared with a control group. Simulated patient exposure with a phantom increased to some extent their performance skills in examination of patients.",2020,"No statistically significant difference in cognitive test scores was seen between the SIM and CAL group, while the CON group scored lower ( p  < 0.003).","[""dental students' cognitive and performance skills"", ""Sixty students (mean age 23.25 years) participated in lectures on the relation between PAN-image errors and patient's head position""]","['control (CON)group, CAL group, and SIM group (both CAL and training in a simulation clinic with a phantom', 'individual learning via computer-assisted-learning (CAL', 'computer-assisted-learning and simulation clinics', 'CON', 'Training with computer-assisted-learning']","[""students' cognitive skills"", 'cognitive test scores']","[{'cui': 'C0038493', 'cui_str': 'Dental Student'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0582540', 'cui_str': 'Head position finding'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0282611', 'cui_str': 'Phantom'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}]","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",60.0,0.0253438,"No statistically significant difference in cognitive test scores was seen between the SIM and CAL group, while the CON group scored lower ( p  < 0.003).","[{'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Wenzel', 'Affiliation': 'Section for Oral Radiology, Department of Dentistry and Oral Health, Health Faculty, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Louise Hauge', 'Initials': 'LH', 'LastName': 'Matzen', 'Affiliation': 'Section for Oral Radiology, Department of Dentistry and Oral Health, Health Faculty, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Rubens', 'Initials': 'R', 'LastName': 'Spin-Neto', 'Affiliation': 'Section for Oral Radiology, Department of Dentistry and Oral Health, Health Faculty, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Schropp', 'Affiliation': 'Section for Oral Radiology, Department of Dentistry and Oral Health, Health Faculty, Aarhus University, Aarhus, Denmark.'}]",Dento maxillo facial radiology,['10.1259/dmfr.20200154']
671,31306800,Outcomes of Long-term Treatment of Chronic HBV Infection With Entecavir or Other Agents From a Randomized Trial in 24 Countries.,"BACKGROUND & AIMS


Treatment of chronic hepatitis B virus (HBV) infection with entecavir suppresses virus replication and reduces disease progression, but could require life-long therapy. To investigate clinical outcome events and safety associated with long-term treatment with entecavir, we followed up patients treated with entecavir or another standard-of-care HBV nucleos(t)ide analogue for up to 10 years. We assessed long-term outcomes and relationships with virologic response.
METHODS


Patients with chronic HBV infection at 299 centers in Asia, Europe, and North and South America were assigned randomly to groups that received entecavir (n = 6216) or an investigator-selected nonentecavir HBV nucleos(t)ide analogue (n = 6162). Study participants were followed up for up to 10 years in hospital-based or community clinics. Key end points were time to adjudicated clinical outcome events and serious adverse events. In a substudy, we examined relationships between these events and virologic response.
RESULTS


There were no significant differences between groups in time to event assessments for primary end points including malignant neoplasms, liver-related HBV disease progression, and death. There were no differences between groups in the secondary end points of nonhepatocellular carcinoma malignant neoplasms and hepatocellular carcinoma. In a substudy of 5305 patients in China, virologic response, regardless of treatment group, was associated with a reduced risk of liver-related HBV disease progression (hazard ratio, 0.09; 95% CI, 0.038-0.221) and hepatocellular carcinoma (hazard ratio, 0.03; 95% CI, 0.009-0.113). Twelve patients given entecavir (0.2%) and 50 patients given nonentecavir drugs (0.8%) reported treatment-related serious adverse events.
CONCLUSIONS


In a randomized controlled trial of patients with chronic HBV infection, we associated entecavir therapy with a low rate of adverse events over 10 years of follow-up evaluation. Patients receiving entecavir vs another nucleos(t)ide analogue had comparable rates of liver- and non-liver-related clinical outcome events. Participants in a China cohort who maintained a virologic response, regardless of treatment group, had a reduced risk of HBV-related outcome events including hepatocellular carcinoma. ClinicalTrials.gov identifier no: NCT00388674.",2020,"There were no significant differences between groups in time to event assessments for primary endpoints including malignant neoplasms, liver-related HBV disease progression, and death.","['Participants in a China cohort who maintained a virologic response, regardless of treatment group, had a reduced risk of HBV-related outcome events including hepatocellular carcinoma', '24 Countries', '5305 patients in China', 'Patients with chronic HBV infection at 299 centers in Asia, Europe, and North and South America', 'patients with chronic HBV infection, we associated entecavir therapy with a low rate of adverse events over 10 years of follow up', 'Study participants were followed for up to 10 years in hospital-based or community clinics']","['entecavir', 'entecavir or another standard of care HBV nucleos(t)ide analogue', 'entecavir (n=6216) or an investigator-selected non-entecavir HBV nucleos(t)ide analogue', 'Entecavir']","['secondary endpoints of non-hepatocellular carcinoma, malignant neoplasms, or hepatocellular carcinoma', 'treatment-related serious adverse events', 'malignant neoplasms, liver-related HBV disease progression, and death', 'Chronic HBV Infection', 'hepatocellular carcinoma', 'reduced risk of liver-related HBV disease progression', 'virologic response', 'time to adjudicated clinical outcome events and serious adverse events', 'rates of liver- and non-liver-related clinical outcome events']","[{'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0205466', 'cui_str': 'virology'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2239176', 'cui_str': 'Liver Cell Carcinoma, Adult'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0037713', 'cui_str': 'South America'}, {'cui': 'C0971023', 'cui_str': 'entecavir'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205136', 'cui_str': 'Over (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0587907', 'cui_str': 'Community clinic (environment)'}]","[{'cui': 'C0971023', 'cui_str': 'entecavir'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C1579410', 'cui_str': 'Nucleoside Analogs'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}]","[{'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C2239176', 'cui_str': 'Liver Cell Carcinoma, Adult'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205466', 'cui_str': 'virology'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",5305.0,0.0842406,"There were no significant differences between groups in time to event assessments for primary endpoints including malignant neoplasms, liver-related HBV disease progression, and death.","[{'ForeName': 'Jin-Lin', 'Initials': 'JL', 'LastName': 'Hou', 'Affiliation': 'Department of Infectious Diseases, Institute of Hepatology, Nanfang Hospital, Southern Medical University, Guangzhou, China. Electronic address: jlhousmu@163.com.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhao', 'Affiliation': 'Department of Infectious Diseases, 2nd Hospital Nanjing, Nanjing, China.'}, {'ForeName': 'Changhyeong', 'Initials': 'C', 'LastName': 'Lee', 'Affiliation': 'Daegu Catholic University Hospital, Daegu, Korea.'}, {'ForeName': 'Hie-Won', 'Initials': 'HW', 'LastName': 'Hann', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Medicine, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania.'}, {'ForeName': 'Cheng-Yuan', 'Initials': 'CY', 'LastName': 'Peng', 'Affiliation': 'Division of Hepatogastroenterology, Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan.'}, {'ForeName': 'Tawesak', 'Initials': 'T', 'LastName': 'Tanwandee', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Bangkok, Thailand.'}, {'ForeName': 'Viacheslav', 'Initials': 'V', 'LastName': 'Morozov', 'Affiliation': 'LLC Medical Company ""Hepatolog,"" Samara, Russian Federation.'}, {'ForeName': 'Hartwig', 'Initials': 'H', 'LastName': 'Klinker', 'Affiliation': 'Department of Medicine II, Division of Hepatology, University of Würzburg Medical Center, Würzberg, Germany.'}, {'ForeName': 'Jose D', 'Initials': 'JD', 'LastName': 'Sollano', 'Affiliation': 'Department of Medicine, Cardinal Santos Medical Center, Manila, Philippines.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Streinu-Cercel', 'Affiliation': 'Department of Infectious Diseases I, Carol Davila University of Medicine and Pharmacy, National Institute for Infectious Diseases, ""Prof. Dr. Matei Bals,"" Bucharest, Romania.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Cheinquer', 'Affiliation': 'Gastroenterology and Hepatology Division, Hospital de Clinicas de Porto Alegre, Porto Alegre, Brazil.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Xie', 'Affiliation': 'Department of Infectious Diseases, Shanghai Rui Jin Hospital, Shanghai, China.'}, {'ForeName': 'Yu-Ming', 'Initials': 'YM', 'LastName': 'Wang', 'Affiliation': 'Institute for Infectious Diseases, Southwest Hospital, Chongqing, China.'}, {'ForeName': 'Lai', 'Initials': 'L', 'LastName': 'Wei', 'Affiliation': ""Hepatology Department, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Ji-Dong', 'Initials': 'JD', 'LastName': 'Jia', 'Affiliation': 'National Clinical Research Center for Digestive Disease, Beijing Friendship Hospital, Capitol Medical University, Beijing, China.'}, {'ForeName': 'Guozhong', 'Initials': 'G', 'LastName': 'Gong', 'Affiliation': 'Department of Infectious Disease, The Second Xiangya Hospital of Central South University, Changsha, China.'}, {'ForeName': 'Kwang-Hyub', 'Initials': 'KH', 'LastName': 'Han', 'Affiliation': 'Department of Internal Medicine, Institute of Gastroenterology and Yonsei Liver Center, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Wukui', 'Initials': 'W', 'LastName': 'Cao', 'Affiliation': ""Department of Infectious Diseases, Tianjin Second People's Hospital, Tianjin, China.""}, {'ForeName': 'Mingliang', 'Initials': 'M', 'LastName': 'Cheng', 'Affiliation': 'Department of Infectious Diseases, Affiliated Hospital of Guiyang Medical College, Guiyang, China.'}, {'ForeName': 'Xiaoping', 'Initials': 'X', 'LastName': 'Tang', 'Affiliation': ""Department of Infectious Diseases, Guangzhou No. 8 People's Hospital, Guangzhou, China.""}, {'ForeName': 'Deming', 'Initials': 'D', 'LastName': 'Tan', 'Affiliation': 'Department of Infectious Diseases, Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Ren', 'Affiliation': 'Department of Infectious Diseases, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Zhongping', 'Initials': 'Z', 'LastName': 'Duan', 'Affiliation': 'Beijing Institute of Hepatology, Beijing YouAn Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Tang', 'Affiliation': 'Center of Infectious Diseases, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Zhiliang', 'Initials': 'Z', 'LastName': 'Gao', 'Affiliation': 'Department of Infectious Diseases, The Third Affiliated Hospital, Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Shijun', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Hepatology Department, Jinan Infectious Disease Hospital, Jinan, China.'}, {'ForeName': 'Shumei', 'Initials': 'S', 'LastName': 'Lin', 'Affiliation': ""Department of Infectious Diseases, The First Affiliated Hospital of Xi'An Jiaotong University, Xi'An, China.""}, {'ForeName': 'Jifang', 'Initials': 'J', 'LastName': 'Sheng', 'Affiliation': 'Department of Infectious Diseases, The First Affiliated Hospital, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Chengwei', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': ""Hepatology Department, 85th Hospital of People's Liberation Army, Shanghai, China.""}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Shang', 'Affiliation': ""Department of Infectious Diseases, Henan Provincial People's hospital, Zhengzhou, China.""}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Han', 'Affiliation': 'Department of Hepatology and Gastroenterology, Tianjin Third Central Hospital, Tianjin, China.'}, {'ForeName': 'Yanyan', 'Initials': 'Y', 'LastName': 'Ji', 'Affiliation': ""Hepatology Department, Shanghai Jing'an District Central Hospital, Shanghai, China.""}, {'ForeName': 'Junqi', 'Initials': 'J', 'LastName': 'Niu', 'Affiliation': 'Hepatobiliary Medical Ward, The First Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Department of Infectious Diseases, Institute of Hepatology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Yongpeng', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Infectious Diseases, Institute of Hepatology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Cooney', 'Affiliation': 'Bristol-Myers Squibb, Inc, Wallingford, Connecticut.'}, {'ForeName': 'Seng-Gee', 'Initials': 'SG', 'LastName': 'Lim', 'Affiliation': 'Division of Gastroenterology and Hepatology, National University Health System, National University of Singapore, Singapore.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2019.07.010']
672,31308282,"Effectiveness of Two Desensitizer Materials, Potassium Nitrate and Fluoride Varnish in Relieving Hypersensitivity After Crown Preparation.","AIM


The aim of this clinical investigation was to compare the efficacy of fluoride varnish and potassium nitrate on the reduction of hypersensitivity of prepared teeth both pre and post cementation.
MATERIALS AND METHODS


In this randomized clinical trial, patients who needed at least three single crowns fixed partial prosthesis were included. Two desensitizing agents including fluoride varnish and potassium nitrate were used in this study and compared to the control group (sterile saline). In each patient, each prepared tooth was randomly assigned to one group. The desensitizing agent was applied on prepared teeth immediately after tooth preparation. The sensitivity of the teeth was measured by means of an air sensitivity test based on the visual analog scale at five different time points: baseline (2 hours after preparation), 7 days after preparation, before cementation, after cementation and one-week post cementation. Data were analyzed by Kruskal-Wallis and Friedman tests with a significant level of 0.05.
RESULTS


Overall 300 vital abutment teeth needed full crown coverage in 100 patients were included. Both desensitizers' agents decreased the sensitivity of vital abutment teeth compared to the control group at every time intervals except at baseline ( p  = 0.089). There was no significant difference between fluoride varnish and potassium nitrate in the reduction of pre-cementation sensitivity while one week after cementation, sensitivity was more relieved by potassium nitrate compared to fluoride varnish ( p  = 0.023).
CONCLUSION


The application of both desensitizers is effective in sensitivity reduction of vital abutment teeth. Potassium nitrate, however, is more eligible one week after cementation compared to fluoride varnish.
CLINICAL SIGNIFICANCE


Both potassium nitrate and fluoride varnish are capable of desensitizing prepared tooth for the fixed partial denture.",2019,Both desensitizers' agents decreased the sensitivity of vital abutment teeth compared to the control group at every time intervals except at baseline ( p  = 0.089).,"['patients who needed at least three single crowns fixed partial prosthesis were included', 'Overall 300 vital abutment teeth needed full crown coverage in 100 patients were included']","['fluoride varnish', 'potassium nitrate and fluoride varnish', 'Two Desensitizer Materials, Potassium Nitrate and Fluoride Varnish', 'fluoride varnish and potassium nitrate', 'Potassium nitrate']","['Relieving Hypersensitivity', 'visual analog scale', 'pre-cementation sensitivity', 'sensitivity of the teeth', 'sensitivity of vital abutment teeth']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C3853546', 'cui_str': 'Dental Crowns'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0442732', 'cui_str': 'Vital (qualifier value)'}, {'cui': 'C0040426', 'cui_str': 'Tooth'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C0016326', 'cui_str': 'Fluoride Varnishes'}, {'cui': 'C0071772', 'cui_str': 'potassium nitrate'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}]","[{'cui': 'C1301771', 'cui_str': 'Relieved'}, {'cui': 'C3544362', 'cui_str': 'Hypersensitivity (SMQ)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0007656', 'cui_str': 'Cementation'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0040426', 'cui_str': 'Tooth'}, {'cui': 'C0442732', 'cui_str': 'Vital (qualifier value)'}]",300.0,0.0409664,Both desensitizers' agents decreased the sensitivity of vital abutment teeth compared to the control group at every time intervals except at baseline ( p  = 0.089).,"[{'ForeName': 'Azadeh', 'Initials': 'A', 'LastName': 'Abdollahi', 'Affiliation': 'UT Health Dental School, San Antonio, Texas, USA; Department of Kinesiology and Health, and Nutrition, University of Texas, San Antonio, United States.'}, {'ForeName': 'Ezzatollah', 'Initials': 'E', 'LastName': 'Jalalian', 'Affiliation': 'Department of Prosthetic Dental Science, College of Dentistry, King Saud University, Riyadh, Kingdom of Saudi Arabia, Phone: +989123238296, e-mail: dr_e_jalalian@yahoo.com.'}]",The journal of contemporary dental practice,[]
673,31958177,Worked examples for teaching electrocardiogram interpretation: Salient or discriminatory features?,"CONTEXT


Cognitive load theory states that one way to optimise learning is to decrease extraneous cognitive load, defined as information not relevant to task completion. Worked examples, which show the learner the logic behind the solving of a problem, can decrease extraneous load. However, there is little research to guide the optimal formatting of worked examples.
METHODS


In a crossover design, first-year medical students were randomised to worked examples of bradycardias with salient features first and tachycardias with discriminatory features second (n = 33) or worked examples of bradycardias with discriminatory features first and tachycardias with salient features second (n = 32). After each learning phase, participants completed a testing phase. Diagnostic accuracy and reported cognitive load were compared between the two worked example formats, as well as with data for a group of historical controls, consisting of medical students interpreting electrocardiogram rhythms without worked examples. Each module concluded with a questionnaire in which the learner was asked to rate his or her perceptions of the difficulty of the core content, the clarity with which the information was presented, and perceived learning.
RESULTS


Worked examples highlighting salient and discriminatory features were associated with similar levels of diagnostic accuracy (56% and 60%, respectively; P = .32). Both worked example conditions were associated with higher diagnostic accuracy than was found in historical controls (P < .0001). There was no difference in the extraneous load experienced between worked examples highlighting salient features and those highlighting discriminatory features (12.5 ± 6.1 and 11.9 ± 6.1, respectively; P = .52). Participants reported greater intrinsic load in the worked examples highlighting salient rather than discriminatory features (17.1 ± 4.9 and 15.5 ± 4.6, respectively; P = .01).
CONCLUSIONS


Discriminatory feature-based worked examples were associated with less intrinsic cognitive load, but this did not translate into any meaningful difference in diagnostic performance. Instruction with worked examples improved diagnostic performance regardless of whether salient or discriminatory features were highlighted.",2020,"RESULTS


Worked examples highlighting salient and discriminating features were associated with similar diagnostic accuracy (56 vs 60%, p = 0.32).",[],[],"['intrinsic load', 'diagnostic accuracy']",[],[],"[{'cui': 'C0439674', 'cui_str': 'Intrinsic (qualifier value)'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}]",,0.044689,"RESULTS


Worked examples highlighting salient and discriminating features were associated with similar diagnostic accuracy (56 vs 60%, p = 0.32).","[{'ForeName': 'Terence Huy', 'Initials': 'TH', 'LastName': 'Thach', 'Affiliation': 'Division of Emergency Medicine, Postgraduate medical education, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Blissett', 'Affiliation': 'Division of Cardiology, Department of Medicine, Western University, London, Ontario, Canada.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Sibbald', 'Affiliation': 'Division of Cardiology, Department of Medicine, Hamilton Health Sciences, McMaster University, Hamilton, Ontario, Canada.'}]",Medical education,['10.1111/medu.14066']
674,31841156,Exploring Patients' Experiences of Internet-Based Self-Management Support for Low Back Pain in Primary Care.,"OBJECTIVE


We explored patients' experiences of using Internet-based self-management support for low back pain (LBP) in primary care, with and without physiotherapist telephone guidance.
DESIGN


Exploratory descriptive qualitative study using thematic analysis, nested within a randomized feasibility trial.
METHODS


Patients with LBP who participated in a feasibility trial of the SupportBack Internet intervention (ISRCTN: 31034004) were invited to take part in semistructured telephone interviews after the three-month intervention period (a convenience sample from within the trial population). Fifteen participants took part (age range = 36-87 years, 66.7% female, characteristics representative of the trial population). Data were analyzed thematically.
RESULTS


Analysis resulted in the development of six themes (subthemes in parentheses): Perceptions of SupportBack's design (Clarity and ease of use, Variety and range of information provided, Need for specificity and flexibility), Engaging with the SupportBack intervention, Promoting positive thought processes (Reassurance, Awareness of self-management), Managing behavior with SupportBack (Motivation and goal setting, Using activity as a pain management strategy, Preferences for walking or gentle back exercises), Feeling supported by telephone physiotherapists (Provision of reassurances and clarity, Physiotherapists are motivating), Severity and comorbidity as barriers (Preexisting condition or severity acting as a barrier, Less useful for mild low back pain).
CONCLUSIONS


The Internet intervention SupportBack appeared to feasibly support self-management of LBP. Reassurance and ongoing support to implement behavioral changes were central to reported benefits. The addition of physiotherapist telephone support further enhanced the patient experience and the potential utility of the intervention.",2020,The Internet intervention SupportBack appeared to feasibly support self-management of LBP.,"[""patients' experiences of using Internet-based self-management support for low back pain (LBP) in primary care, with and without physiotherapist telephone guidance"", 'Fifteen participants took part (age range = 36-87 years, 66.7% female, characteristics representative of the trial population', 'Patients with LBP who participated in a feasibility trial of the SupportBack Internet intervention (ISRCTN: 31034004) were invited to take part in semistructured telephone interviews after the three-month intervention period (a convenience sample from within the trial population', 'for Low Back Pain in Primary Care']","['Internet-Based Self-Management Support', 'physiotherapist telephone']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0024031', 'cui_str': 'Low Back Ache'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapists'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517843', 'cui_str': '66.7 (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0021823', 'cui_str': 'Interviews, Telephone'}, {'cui': 'C4082119', 'cui_str': 'Three months (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapists'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}]",[],15.0,0.0816618,The Internet intervention SupportBack appeared to feasibly support self-management of LBP.,"[{'ForeName': 'Adam W A', 'Initials': 'AWA', 'LastName': 'Geraghty', 'Affiliation': 'Primary Care, Population Sciences and Medical Education, University of Southampton, Southampton, UK.'}, {'ForeName': 'Lisa C', 'Initials': 'LC', 'LastName': 'Roberts', 'Affiliation': 'School of Health Sciences, University of Southampton & University Hospital Southampton NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Rosie', 'Initials': 'R', 'LastName': 'Stanford', 'Affiliation': 'Primary Care, Population Sciences and Medical Education, University of Southampton, Southampton, UK.'}, {'ForeName': 'Jonathan C', 'Initials': 'JC', 'LastName': 'Hill', 'Affiliation': 'Arthritis Research UK Primary Care Centre, Institute for Primary Care and Health Sciences, Keele University, Newcastle, UK.'}, {'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Yoganantham', 'Affiliation': 'Primary Care, Population Sciences and Medical Education, University of Southampton, Southampton, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Little', 'Affiliation': 'Primary Care, Population Sciences and Medical Education, University of Southampton, Southampton, UK.'}, {'ForeName': 'Nadine E', 'Initials': 'NE', 'LastName': 'Foster', 'Affiliation': 'Arthritis Research UK Primary Care Centre, Institute for Primary Care and Health Sciences, Keele University, Newcastle, UK.'}, {'ForeName': 'Elaine M', 'Initials': 'EM', 'LastName': 'Hay', 'Affiliation': 'Arthritis Research UK Primary Care Centre, Institute for Primary Care and Health Sciences, Keele University, Newcastle, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Yardley', 'Affiliation': 'School of Psychological Science, University of Bristol, Bristol, UK.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnz312']
675,31800360,Self-Perceived Improvement in Bladder Health After Viewing a Novel Tutorial on Knack Use: A Randomized Controlled Trial Pilot Study.,"Purpose:  To test a novel bladder health tutorial on use of the Knack for overcoming bladder control challenges. The Knack-tutorial is a self-administered vignette-based instructional program on preempting bladder challenges in daily life (urgency, stress-leakage, or urge-leakage) through anticipatory, well-timed pelvic floor muscle contraction at the moment of challenge.  Materials and Methods:  This is a randomized controlled trial pilot test of 108 women with stress or mixed urinary incontinence. The Knack-tutorial group saw a 15-minute slide show with 10 vignettes portraying use of the Knack in daily life. The slide show format used inserted narrated videos, dubbed and animation enhanced pictures and cartoons, and automatic slide advancement. A control group saw a similarly constructed slide show on incorporating good diet/exercise habits. Outcomes were self-perceived improvement (yes/no, and as 0%-100%) 1 month after viewing the tutorial.  Results:  We enrolled 123 women, randomizing 64 to Knack-tutorial group and 59 to diet/exercise tutorial group. Eleven and one participant, respectively, did not return. Three did not fill out the self-perceived improvement report. Significant improvement was reported by 71% in the Knack-tutorial group compared to 25% in the diet/exercise group ( p  < 0.001). Self-perceived improvement was 21%-22% higher (Model I Est: 21.01, SE: 4.25,  p  < 0.001) in the Knack-tutorial group.  Conclusions:  An electronic tutorial viewed independent of a health care provider with vignettes showing Knack application to manage the everyday bladder challenges women face shows benefit of a magnitude that warrants more widespread use and rigorous testing. A professional remake of the intervention is now available (www.myconfidentbladder.com).",2020,Significant improvement was reported by 71% in the Knack-tutorial group compared to 25% in the diet/exercise group ( p  < 0.001).,"['123 women, randomizing 64 to Knack-tutorial group and 59 to diet/exercise tutorial group', '108 women with stress or mixed urinary incontinence']",[],"['Self-Perceived Improvement in Bladder Health', 'Self-perceived improvement']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C1720722', 'cui_str': 'Mix'}, {'cui': 'C0042024', 'cui_str': 'Urinary Incontinence'}]",[],"[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0005682', 'cui_str': 'Bladder'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",123.0,0.0526011,Significant improvement was reported by 71% in the Knack-tutorial group compared to 25% in the diet/exercise group ( p  < 0.001).,"[{'ForeName': 'Janis M', 'Initials': 'JM', 'LastName': 'Miller', 'Affiliation': 'Department of Health Behavior and Biological Sciences, University of Michigan School of Nursing, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Kieran M', 'Initials': 'KM', 'LastName': 'Hawthorne', 'Affiliation': 'Arbor Research Collaborative for Health, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Park', 'Affiliation': 'Department of Health Behavior and Biological Sciences, University of Michigan School of Nursing, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Tolbert', 'Affiliation': 'Department of Health Behavior and Biological Sciences, University of Michigan School of Nursing, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Bies', 'Affiliation': 'Department of Health Behavior and Biological Sciences, University of Michigan School of Nursing, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Garcia', 'Affiliation': 'Department of Health Behavior and Biological Sciences, University of Michigan School of Nursing, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Ruta', 'Initials': 'R', 'LastName': 'Misiunas', 'Affiliation': 'Department of Health Behavior and Biological Sciences, University of Michigan School of Nursing, Ann Arbor, Michigan, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Newhouse', 'Affiliation': 'Center for Health Communications Research, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Abigail R', 'Initials': 'AR', 'LastName': 'Smith', 'Affiliation': 'Arbor Research Collaborative for Health, Ann Arbor, Michigan, USA.'}]",Journal of women's health (2002),['10.1089/jwh.2018.7606']
676,31272939,Temsirolimus versus Pazopanib (TemPa) in Patients with Advanced Clear-cell Renal Cell Carcinoma and Poor-risk Features: A Randomized Phase II Trial.,"BACKGROUND


Temsirolimus has level 1 evidence for initial treatment of poor-risk patients with advanced renal cell carcinoma (mRCC), but its efficacy has not been directly compared with an antiangiogenic tyrosine kinase inhibitor (vascular endothelial growth factor receptor tyrosine kinase inhibitor [VEGFR TKi]) in this setting.
OBJECTIVE


To evaluate temsirolimus versus pazopanib as first-line therapy in patients with mRCC, predominant clear-cell features, and clinical characteristics of a poor prognosis.
DESIGN, SETTING, AND PARTICIPANTS


A randomized (1:1) phase II trial in 69 treatment-naïve mRCC patients and with three or more predictors of short survival for temsirolimus was conducted during 2012-2017 in a single academic cancer center. Crossover to the alternative treatment upon discontinuation of the first-line agent was permitted.
INTERVENTION


Mechanistic target of rapamycin inhibitor temsirolimus and VEGFR TKi pazopanib.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS


The primary endpoint was progression-free survival (PFS), and the secondary endpoints were overall survival (OS), objective response rate (ORR), safety, and patient-reported outcomes (PROs). Radiographic response was assessed by blinded radiologists. Efficacy outcomes were adjusted by prior nephrectomy status, prior interleukin-2 treatment, and the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) score.
RESULTS AND LIMITATIONS


Thirty-five patients received temsirolimus and 34 received pazopanib upfront; 72% overall had poor risk by IMDC. Median PFS in the first line was 2.7mo with temsirolimus and 5.2mo with pazopanib (adjusted hazard ratio [HR] 1.36, 95% confidence interval [CI] 0.84-2.22; p=0.210). Median OS was 7.1mo with temsirolimus and 11.9mo with pazopanib (adjusted HR 1.16, 95% CI 0.70-1.93; p=0.558), and ORRs were 5.9% and 21.2%, respectively (adjusted odds ratio 5.2, 95% CI 0.9-29.3; p=0.062). PRO measures favored pazopanib. Five patients discontinued first-line therapy due to adverse events.
CONCLUSIONS


Temsirolimus and pazopanib had modest activity in patients with poor-risk clear-cell mRCC, and therefore their use should be discouraged in this setting.
PATIENT SUMMARY


We evaluated outcomes of advanced renal cell carcinoma patients presenting with aggressive features when treated with temsirolimus or pazopanib as first-line therapy. Survival was <1yr for most, suggesting that more efficacious alternative treatments should be favored for these patients.",2020,"Median PFS in the first line was 2.7mo with temsirolimus and 5.2mo with pazopanib (adjusted hazard ratio [HR] 1.36, 95% confidence interval [CI] 0.84-2.22; p=0.210).","['patients with mRCC', 'patients with poor-risk clear-cell mRCC', '69 treatment-naïve mRCC patients and with three or more predictors of short survival for temsirolimus was conducted during 2012-2017 in a single academic cancer center', 'Patients with Advanced Clear-cell Renal Cell Carcinoma and Poor-risk Features', 'advanced renal cell carcinoma patients presenting with aggressive features when treated with', 'poor-risk patients with advanced renal cell carcinoma (mRCC']","['Temsirolimus versus Pazopanib (TemPa', 'Temsirolimus and pazopanib', 'temsirolimus or pazopanib', 'rapamycin inhibitor temsirolimus and VEGFR TKi pazopanib', 'pazopanib', 'pazopanib upfront']","['progression-free survival (PFS', 'Survival', 'Radiographic response', 'overall survival (OS), objective response rate (ORR), safety, and patient-reported outcomes (PROs', 'Median OS', 'ORRs', 'International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) score', 'Median PFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0229473', 'cui_str': 'Cell of Claudius (cell)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1707080', 'cui_str': 'temsirolimus'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0279702', 'cui_str': 'Clear Cell Renal Carcinoma'}, {'cui': 'C0007134', 'cui_str': 'Nephroid Carcinoma'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C1707080', 'cui_str': 'temsirolimus'}, {'cui': 'C1831796', 'cui_str': 'pazopanib'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0278678', 'cui_str': 'Metastatic renal cell carcinoma'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",69.0,0.0983514,"Median PFS in the first line was 2.7mo with temsirolimus and 5.2mo with pazopanib (adjusted hazard ratio [HR] 1.36, 95% confidence interval [CI] 0.84-2.22; p=0.210).","[{'ForeName': 'Nizar M', 'Initials': 'NM', 'LastName': 'Tannir', 'Affiliation': 'Department of Genitourinary Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA. Electronic address: ntannir@mdanderson.org.'}, {'ForeName': 'Pavlos', 'Initials': 'P', 'LastName': 'Msaouel', 'Affiliation': 'Department of Genitourinary Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Jeremy A', 'Initials': 'JA', 'LastName': 'Ross', 'Affiliation': 'Department of Genitourinary Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Catherine E', 'Initials': 'CE', 'LastName': 'Devine', 'Affiliation': 'Department of Radiology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Anuradha', 'Initials': 'A', 'LastName': 'Chandramohan', 'Affiliation': 'Department of Radiology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Graciela M Nogueras', 'Initials': 'GMN', 'LastName': 'Gonzalez', 'Affiliation': 'Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Xuemei', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Genitourinary Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Paul G', 'Initials': 'PG', 'LastName': 'Corn', 'Affiliation': 'Department of Genitourinary Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Zita D', 'Initials': 'ZD', 'LastName': 'Lim', 'Affiliation': 'Department of Genitourinary Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Pruitt', 'Affiliation': 'Department of Genitourinary Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Jose A', 'Initials': 'JA', 'LastName': 'Karam', 'Affiliation': 'Department of Urology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Christopher G', 'Initials': 'CG', 'LastName': 'Wood', 'Affiliation': 'Department of Urology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Amado J', 'Initials': 'AJ', 'LastName': 'Zurita', 'Affiliation': 'Department of Genitourinary Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}]",European urology oncology,['10.1016/j.euo.2019.06.004']
677,31804398,Five Year Follow-up of a Randomized Controlled Trial of Laparoscopic Repair of Very Large Hiatus Hernia With Sutures Versus Absorbable Versus Nonabsorbable Mesh.,"OBJECTIVE


To determine whether absorbable or nonabsorbable mesh repair of large hiatus hernias is followed by less recurrences at late follow-up compared to sutured repair.
SUMMARY OF BACKGROUND DATA


Radiological recurrences have been reported in up to 30% of patients after repair of large hiatus hernias, and mesh repair has been proposed as a solution. Earlier trials have revealed mixed outcomes and early outcomes from a trial reported previously revealed no short-term advantages for mesh repair.
METHODS


Multicentre prospective double-blind randomized controlled trial of 3 methods of hiatus hernia repair; sutures versus absorbable mesh versus nonabsorbable mesh. Primary outcome - hernia recurrence assessed by barium meal X-ray and endoscopy at 3-4 years. Secondary outcomes - clinical symptom scores at 2, 3, and 5 years.
RESULTS


126 patients were enrolled - 43 sutures, 41 absorbable mesh, and 42 nonabsorbable mesh. Clinical outcomes were obtained at 5 years in 89.9%, and objective follow-up was obtained in 72.3%. A recurrent hernia (any size) was identified in 39.3% after suture repair, 56.7% - absorbable mesh, and 42.9% - nonabsorbable mesh (P = 0.371). Clinical outcomes were similar at 5 years, except chest pain, diarrhea, and bloat symptoms which were more common after repair with absorbable mesh.
CONCLUSIONS


No advantages were demonstrated for mesh repair at up to 5 years follow-up, and symptom outcomes were worse after repair with absorbable mesh. The longer-term results from this trial do not support mesh repair for large hiatus hernias.",2019,"No advantages were demonstrated for mesh repair at up to 5 years follow-up, and symptom outcomes were worse after repair with absorbable mesh.","['126 patients were enrolled - 43 sutures, 41 absorbable mesh, and 42 nonabsorbable mesh']","['Laparoscopic Repair of Very Large Hiatus Hernia With Sutures Versus Absorbable Versus Nonabsorbable Mesh', 'hiatus hernia repair; sutures versus absorbable mesh versus nonabsorbable mesh', 'absorbable or nonabsorbable mesh repair']","['clinical symptom scores at 2, 3, and 5 years', 'recurrent hernia', 'chest pain, diarrhea, and bloat symptoms', 'hernia recurrence assessed by barium meal X-ray and endoscopy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0181805', 'cui_str': 'Mesh (physical object)'}, {'cui': 'C0450155', 'cui_str': 'Nonabsorbable mesh (physical object)'}]","[{'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0450093', 'cui_str': 'Very large (qualifier value)'}, {'cui': 'C3489393', 'cui_str': 'Hiatal Hernia'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0450155', 'cui_str': 'Nonabsorbable mesh (physical object)'}, {'cui': 'C0014857', 'cui_str': 'Repair of parahiatal diaphragmatic hernia (procedure)'}, {'cui': 'C0181805', 'cui_str': 'Mesh (physical object)'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0008031', 'cui_str': 'Chest Pain'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C1291077', 'cui_str': 'Abdomen feels bloated'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0412103', 'cui_str': 'Barium meal (procedure)'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}]",126.0,0.479725,"No advantages were demonstrated for mesh repair at up to 5 years follow-up, and symptom outcomes were worse after repair with absorbable mesh.","[{'ForeName': 'David I', 'Initials': 'DI', 'LastName': 'Watson', 'Affiliation': 'Flinders University Discipline of Surgery, Flinders Medical Centre, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Sarah K', 'Initials': 'SK', 'LastName': 'Thompson', 'Affiliation': 'Flinders University Discipline of Surgery, Flinders Medical Centre, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Devitt', 'Affiliation': 'Discipline of Surgery, University of Adelaide, Royal Adelaide Hospital, Adelaide, South Australia, Australia.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Aly', 'Affiliation': 'University of Melbourne Department of Surgery, Austin Hospital, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Irvine', 'Affiliation': 'Flinders University Discipline of Surgery, Flinders Medical Centre, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Simon D', 'Initials': 'SD', 'LastName': 'Woods', 'Affiliation': 'Cabrini Hospital, Malvern, Victoria, Australia.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Gan', 'Affiliation': 'Flinders University Discipline of Surgery, Flinders Medical Centre, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Philip A', 'Initials': 'PA', 'LastName': 'Game', 'Affiliation': 'Discipline of Surgery, University of Adelaide, Royal Adelaide Hospital, Adelaide, South Australia, Australia.'}, {'ForeName': 'Glyn G', 'Initials': 'GG', 'LastName': 'Jamieson', 'Affiliation': 'Discipline of Surgery, University of Adelaide, Royal Adelaide Hospital, Adelaide, South Australia, Australia.'}]",Annals of surgery,['10.1097/SLA.0000000000003734']
678,31802217,Intraluminal flexible sheath for the protection of low anastomosis after anterior resection: results from a First-In-Human trial on 15 patients.,"BACKGROUND


Defunctioning ostomy is commonly used to protect patients from anastomotic leakage complications after low anterior resection, but is fraught with its own deleterious effects. This first-in-human study examines the safety and preliminary efficacy of Colovac, an anastomosis protection device. The Colovac consists of a flexible bypass sheath, placed in the lumen of colon and anchored above the anastomosis using a vacuum stent.
METHODS


15 patients underwent anterior resection (AR) with anastomosis protection by Colovac at 3 European centers. After 14 days, the anastomosis integrity was examined by CT scan and endoscopy. The device was then endoscopically removed. Data regarding demographics, surgical details, 30 day post-operative complications, and patient satisfaction were collected prospectively.
RESULTS


15 patients (10 male) underwent laparoscopic AR with Colovac placement. Preoperative neoadjuvant therapy was administered to 54% of patients. Device placement was uneventful in all patients with a median duration of 7 min and placement was judged as easy or very easy in 93% of the cases. Patients did not report major discomfort during the 14 days. Endoscopic removal (10 min) was judged as easy or very easy in 87% of the cases. Absence of feces below the Colovac anchoring site was observed in 100% of the cases. 4 anastomotic leakages were observed (including 3 device migrations). Overall 5 patients (33%) required a planned stoma creation. At 3 months, 1 had already been closed.
CONCLUSION


Colovac provides a minimally invasive protection of the anastomosis during the healing process by avoiding the need for a diverting ostomy for two-thirds of patients who will not experience anastomotic complications and allowing safe conversion to the standard of care for patients requiring extended anastomotic protection. A larger study is ongoing to confirm these results.",2020,Device placement was uneventful in all patients with a median duration of 7 min and placement was judged as easy or very easy in 93% of the cases.,"['15 patients underwent anterior resection (AR) with anastomosis protection by Colovac at 3 European centers', '15 patients (10 male) underwent', '15 patients']","['Preoperative neoadjuvant therapy', 'laparoscopic AR with Colovac placement', 'Intraluminal flexible sheath']","['planned stoma creation', 'Endoscopic removal', 'anastomosis integrity', '4 anastomotic leakages']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis (morphologic abnormality)'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant Treatment'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0442115', 'cui_str': 'Intraluminal (qualifier value)'}, {'cui': 'C0443220', 'cui_str': 'Flexible (qualifier value)'}, {'cui': 'C0009653', 'cui_str': 'Condoms'}]","[{'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C4552218', 'cui_str': 'Stoma creation'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis (morphologic abnormality)'}, {'cui': 'C1947912', 'cui_str': 'Integrity (attribute)'}, {'cui': 'C0919691', 'cui_str': 'Anastomotic Leakage'}]",,0.0262474,Device placement was uneventful in all patients with a median duration of 7 min and placement was judged as easy or very easy in 93% of the cases.,"[{'ForeName': 'Antonio', 'Initials': 'A', 'LastName': ""D'Urso"", 'Affiliation': 'Department of General, Digestive, and Endocrine Surgery, University Hospital of Strasbourg, Strasbourg, France.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Komen', 'Affiliation': 'Department of Abdominal Surgery, University Hospital Antwerp, University of Antwerp, Edegem, Belgium.'}, {'ForeName': 'Jérémie H', 'Initials': 'JH', 'LastName': 'Lefevre', 'Affiliation': 'Department of Digestive Surgery, Sorbonne Université, AP-HP, Hôpital Saint-Antoine, 75012, Paris, France. jeremie.lefevre@aphp.fr.'}]",Surgical endoscopy,['10.1007/s00464-019-07279-8']
679,31259802,Improved Reduction of the Tibio-Fibular Syndesmosis with Tightrope compared to Screw Fixation: Results of a Randomized Controlled Study.,"OBJECTIVE


To compare the rate of malreduction following high fibular fractures associated with syndesmosis injury treated with open reduction and internal fixation, with either two screws or one knotless Tightrope device.
DESIGN


Prospective randomized controlled multicenter trial SETTING:: Eleven academic and community hospitals including level 1 and 2 trauma centers across CanadaPatients/Participants: One hundred three patients with OTA/AO 44-C injuries with demonstrated radiographic syndesmosis diastasis or instability following malleolar bony fixation were followed for 12 months after treatment.
METHODS


Open reduction of the syndesmosis was performed in all cases. Fixation was randomized to either Tightrope (one knotless Tightrope, Group T) or screw fixation (two 3.5 mm cortical positional screws placed across 3 cortices, Group S). Surgical techniques and rehabilitation were standardized. All surgeons were trained or experienced in the use of the Tightrope device. Follow up was performed at 2 and 6 weeks, 3, 6 and 12 months.
MAIN OUTCOME MEASURE


Rate of malreduction based on bilateral ankle CT scan results at 3 months post fixation. Secondary outcome measures included adverse events, reoperation, and validated functional outcomes including the EQ5D, the Olerud-Molander Ankle Score (OM), the Foot and Ankle Disability Index (FADI), and the Work Productivity Activity Impairment Questionnaire (WPAI). The estimated sample size required to detect a difference in reduction rate was 72 patients, but the estimated sample size required to detect a difference in functional outcome scores was 240 patients, suggesting the study was adequately powered for radiographic results only.
RESULTS


Overall, the rate of malreduction using screw fixation was 39 % compared with 15 % using Tightrope fixation (p = 0.028, Chi square). Analysis of CT results was performed using a 2 mm translation or 10 degree rotation threshold for malreduction, and included fibular translation (anterior, posterior); syndesmosis distance (anterior, posterior, mid); medial compression; and rotation (fibular and articular). Patients in Group T had greater anterior translation (5.4 ± 1.8 mm) compared to the contralateral limb (4.3 ± 1.3 mm, p<0.01) or Group S (4.6 ± 1.5 mm, p = 0.05). Group T syndesmoses also had greater diastasis compared to control limb (4.1 ± 1.3 vs 3.3 ± 1.4 mm, p<0.01) and less fibular medialization compared to Group S (1.04 ± 1.8 vs 0.3± 1.8 mm, p = 0.05). Functional outcome measures demonstrated significant improvements over time, but no differences between fixation groups. FADI scores at each time interval were: 44 ± 22 (T) vs 45 ± 24 (S) (6 weeks), 76 ± 14 vs 73 ± 17 (3 months), 89 ± 10 vs 86 ± 13 (6 months), and 93 ± 9 vs 90 ± 14 (12 months) (all p > 0.2). The reoperation rate was higher in the screw group compared to Tightrope (30% vs 4%, p= 0.02) with the difference driven by the rate of implant removal.
CONCLUSION


Based upon our results the Tightrope device appears to compare favorably to two, 3.5 mm, 3- cortex screw fixation for syndesmosis injuries.",2019,"Patients in Group T had greater anterior translation (5.4 ± 1.8 mm) compared to the contralateral limb (4.3 ± 1.3 mm, p<0.01) or Group S (4.6 ± 1.5 mm, p = 0.05).","[' Eleven academic and community hospitals including level 1 and 2 trauma centers across CanadaPatients/Participants: One hundred three patients with OTA/AO 44-C injuries with demonstrated radiographic syndesmosis diastasis or instability following malleolar bony fixation were followed for 12 months after treatment', 'syndesmosis injuries']","['Tightrope (one knotless Tightrope, Group T) or screw fixation', 'syndesmosis injury treated with open reduction and internal fixation, with either two screws or one knotless Tightrope device', 'Screw Fixation', '3- cortex screw fixation']","['rate of malreduction using screw fixation', 'Rate of malreduction based on bilateral ankle CT scan results at 3 months post fixation', 'greater anterior translation', 'fibular translation (anterior, posterior); syndesmosis distance (anterior, posterior, mid); medial compression; and rotation (fibular and articular', 'FADI scores', 'reoperation rate', 'adverse events, reoperation, and validated functional outcomes including the EQ5D, the Olerud-Molander Ankle Score (OM), the Foot and Ankle Disability Index (FADI), and the Work Productivity Activity Impairment Questionnaire (WPAI', 'rate of implant removal', 'fibular medialization']","[{'cui': 'C0020003', 'cui_str': 'Hospitals, Community'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0456947', 'cui_str': 'Level 1 (qualifier value)'}, {'cui': 'C0040786', 'cui_str': 'Trauma Centers'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0224512', 'cui_str': 'Syndesmosis structure'}, {'cui': 'C0036679', 'cui_str': 'Separation (morphologic abnormality)'}, {'cui': 'C1444783', 'cui_str': 'Instability'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0443157', 'cui_str': 'Bony (qualifier value)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0001758', 'cui_str': 'Follow-Up Care'}]","[{'cui': 'C0036669', 'cui_str': 'T-Groups'}, {'cui': 'C0301559', 'cui_str': 'Screw (physical object)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0224512', 'cui_str': 'Syndesmosis structure'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C2370853', 'cui_str': 'Open reduction (procedure)'}, {'cui': 'C0016642', 'cui_str': 'Osteosynthesis, Fracture'}, {'cui': 'C0220819', 'cui_str': 'devices'}]","[{'cui': 'C0301559', 'cui_str': 'Screw (physical object)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0040405', 'cui_str': 'Tomography, Xray Computed'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0040712', 'cui_str': 'Translations'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0224512', 'cui_str': 'Syndesmosis structure'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0035110', 'cui_str': 'Revision Surgery'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0561946', 'cui_str': 'Removal of implant (procedure)'}]",103.0,0.107881,"Patients in Group T had greater anterior translation (5.4 ± 1.8 mm) compared to the contralateral limb (4.3 ± 1.3 mm, p<0.01) or Group S (4.6 ± 1.5 mm, p = 0.05).","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Sanders', 'Affiliation': 'London Health Sciences Centre, Victoria Hospital 800 Commissioners Rd E, E1-324, London, Ontario CANADA N6A 4G5 Tel: 519-685-8086 Fax: 519-685-8019.'}, {'ForeName': 'Prism', 'Initials': 'P', 'LastName': 'Schneider', 'Affiliation': 'Foothills Medical Centre McCaig Tower, 3134 Hospital Drive NW, Calgary, Alberta CANADA T2N 5A1 Tel: (403) 944-4518 Fax: (403) 270-8004.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Taylor', 'Affiliation': 'London Health Sciences Centre, Victoria Hospital 800 Commissioners Rd E, E1-324, London, Ontario CANADA N6A 4G5 Tel: 519-685-8086 Fax: 519-685-8019.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Tieszer', 'Affiliation': 'London Health Sciences Centre, Victoria Hospital 800 Commissioners Rd E, E1-414London, Ontario CANADA N6A 4G5 Tel: 519-685-8500 x 55362 Fax: 519-685-8059.'}, {'ForeName': 'Abdel-Rahman', 'Initials': 'AR', 'LastName': 'Lawendy', 'Affiliation': 'London Health Sciences Centre, Victoria Hospital 800 Commissioners Rd E, E1-325, London, Ontario CANADA N6A 4G5 Tel: 519-685-8218 Fax: 519-685-8059 800 Commissioners Road East, Room E1-326 London, Ontario CANADA N6A 4G5 Tel: (519) 685-8086 Fax: (519) 685-8016 Email: david.sanders@lhsc.on.ca.'}]",Journal of orthopaedic trauma,['10.1097/BOT.0000000000001559']
680,31693275,Role of endogenous glucagon-like peptide-1 enhanced by vildagliptin in the glycaemic and energy expenditure responses to intraduodenal fat infusion in type 2 diabetes.,"AIM


To evaluate the effects of the dipeptidyl peptidase-4 (DPP-4) inhibitor vildagliptin on glycaemic and energy expenditure responses during intraduodenal fat infusion, as well as the contribution of endogenous glucagon-like peptide-1 (GLP-1) signalling, in people with type 2 diabetes (T2DM).
METHODS


A total of 15 people with T2DM managed by diet and/or metformin (glycated haemoglobin 49.3 ± 2.1 mmol/mol) were studied on three occasions (two with vildagliptin and one with placebo) in a double-blind, randomized, crossover fashion. On each day, vildagliptin 50 mg or placebo was given orally, followed by intravenous exendin (9-39) 600 pmol/kg/min, on one of the two vildagliptin treatment days, or 0.9% saline over 180 minutes. At between 0 and 120 minutes, a fat emulsion was infused intraduodenally at 2 kcal/min. Energy expenditure, plasma glucose and glucose-regulatory hormones were evaluated.
RESULTS


Intraduodenal fat increased plasma GLP-1 and glucose-dependent insulinotropic polypeptide (GIP), insulin and glucagon, and energy expenditure, and decreased plasma glucose (all P < 0.05). On the two intravenous saline days, plasma glucose and glucagon were lower, plasma intact GLP-1 was higher (all P < 0.05), and energy expenditure tended to be lower after vildagliptin (P = 0.08) than placebo. On the two vildagliptin days, plasma glucose, glucagon and GLP-1 (both total and intact), and energy expenditure were higher during intravenous exendin (9-39) than saline (all P < 0.05).
CONCLUSIONS


In well-controlled T2DM during intraduodenal fat infusion, vildagliptin lowered plasma glucose and glucagon, and tended to decrease energy expenditure, effects that were mediated by endogenous GLP-1.",2020,"RESULTS


Intraduodenal fat increased plasma GLP-1 and GIP, insulin and glucagon, and energy expenditure, and decreased plasma glucose (all P<0.05).","['type 2 diabetes', '15 T2DM patients, managed by diet and/or metformin (HbA1c 6.7±0.2%), were studied on 3 occasions (two with', 'type 2 diabetes (T2DM']","['vildagliptin and one placebo', 'placebo', 'endogenous glucagon-like peptide-1 enhanced by vildagliptin', 'Dipeptidyl peptidase-4', 'vildagliptin']","['plasma intact GLP-1', 'energy expenditure', 'plasma GLP-1 and GIP, insulin and glucagon, and energy expenditure, and decreased plasma glucose', 'blood glucose and glucagon and increase energy expenditure', 'plasma glucose, glucagon and GLP-1 (both total and intact), and energy expenditure', 'Energy expenditure, plasma glucose and glucose-regulatory hormones', 'plasma glucose and glucagon']","[{'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C1570906', 'cui_str': 'vildagliptin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205227', 'cui_str': 'Endogenous (qualifier value)'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C0081937', 'cui_str': 'Dipeptidyl-Peptidase IV'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0205266', 'cui_str': 'Intact (qualifier value)'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C0014272', 'cui_str': 'Energy Expenditure'}, {'cui': 'C1702020', 'cui_str': '37-epsilon-palmitoyl-Lys-GIP'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0876232', 'cui_str': 'glucagon recombinant'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0455769', 'cui_str': 'Increased energy (finding)'}, {'cui': 'C0015316', 'cui_str': 'Expenditures'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}]",,0.0673724,"RESULTS


Intraduodenal fat increased plasma GLP-1 and GIP, insulin and glucagon, and energy expenditure, and decreased plasma glucose (all P<0.05).","[{'ForeName': 'Cong', 'Initials': 'C', 'LastName': 'Xie', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence in Translating Nutritional Science to Good Health, University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Xuyi', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence in Translating Nutritional Science to Good Health, University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Jones', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence in Translating Nutritional Science to Good Health, University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Horowitz', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence in Translating Nutritional Science to Good Health, University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Zilin', 'Initials': 'Z', 'LastName': 'Sun', 'Affiliation': 'Department of Endocrinology, Zhongda Hospital, Institute of Diabetes, School of Medicine, Southeast University, Nanjing, China.'}, {'ForeName': 'Tanya J', 'Initials': 'TJ', 'LastName': 'Little', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence in Translating Nutritional Science to Good Health, University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Christopher K', 'Initials': 'CK', 'LastName': 'Rayner', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence in Translating Nutritional Science to Good Health, University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Tongzhi', 'Initials': 'T', 'LastName': 'Wu', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence in Translating Nutritional Science to Good Health, University of Adelaide, Adelaide, South Australia, Australia.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13906']
681,31272953,Binocular game versus part-time patching for treatment of anisometropic amblyopia in Chinese children: a randomised clinical trial.,"AIMS


To compare amblyopic-eye visual acuity (VA) and binocularity improvement of a binocular game with part-time patching in the treatment of Chinese children with anisometropic amblyopia.
METHODS


103 Chinese children aged 3-13 years with anisometropic amblyopia were recruited in a randomised clinical trial. Eligible participants were randomly assigned to the binocular, patching and combined groups. Primary outcome was amblyopic-eye VA improvement at 3 months. Secondary outcomes included reduction of suppression and change of stereoacuity.
RESULTS


Of 85 completed participants, 44 (52%) were women and mean (SD) age was 5.99 (2.33) years. At 3 months, mean (95% CI) amblyopic-eye VA improved 0.18 (0.10-0.26), 0.28 (0.19-0.36) and 0.30 (0.21-0.39) logarithm of the minimum angle of resolution in the binocular, patching and combined groups, respectively. After adjusting for baseline VA, the difference was statistically significant (F=6.29, p=0.003), favouring as follows: the combined group, the patching group and the binocular group. After treatment, Titmus (x 2   binocular =9.75, p=0.007; x 2   combined =9.35, p=0.009) and dynamic stereoacuity (x 2   binocular =12.56, p=0.01; x 2   combined =12.66, p=0.01) improved only in the binocular and combined groups. Among groups, only Titmus improvement differed significantly (F=49.55, p<0.001). Changes of other types of stereoacuity and interocular suppression were similar.
CONCLUSIONS


The binocular game used in this study could improve amblyopic-eye VA and binocularity in Chinese children with anisometropic amblyopia, but it was less effective than patching in amblyopic-eye VA improvement and showed no superiority in binocularity over patching. It remains unclear whether the low treatment response of this binocular game was due to limitations of the study or its low treatment effect.",2020,"Among groups, only Titmus improvement differed significantly (F=49.55, p<0.001).","['anisometropic amblyopia in Chinese children', 'Of 85 completed participants, 44 (52%) were women and mean', 'Chinese children with anisometropic amblyopia', '103 Chinese children aged 3-13 years with anisometropic amblyopia', 'Eligible participants']","['Binocular game versus part-time patching', 'binocular game with part-time patching']","['amblyopic-eye VA improvement', 'reduction of suppression and change of stereoacuity', 'dynamic stereoacuity']","[{'cui': 'C0339696', 'cui_str': 'Anisometropic Amblyopia'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517526', 'cui_str': 'One hundred and three'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C2594855', 'cui_str': 'Binoculars'}, {'cui': 'C1632851', 'cui_str': 'Times'}]","[{'cui': 'C0002418', 'cui_str': 'Amblyopia'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1275505', 'cui_str': 'Stereoscopic acuity (observable entity)'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}]",103.0,0.341821,"Among groups, only Titmus improvement differed significantly (F=49.55, p<0.001).","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Yao', 'Affiliation': 'Department of Ophthalmology and Vision Science, Eye & ENT Hospital, Shanghai Medical School, Fudan University, Shanghai, China.'}, {'ForeName': 'Hye-Won', 'Initials': 'HW', 'LastName': 'Moon', 'Affiliation': 'Department of Ophthalmology and Vision Science, Eye & ENT Hospital, Shanghai Medical School, Fudan University, Shanghai, China.'}, {'ForeName': 'Xiaomei', 'Initials': 'X', 'LastName': 'Qu', 'Affiliation': 'Department of Ophthalmology and Vision Science, Eye & ENT Hospital, Shanghai Medical School, Fudan University, Shanghai, China quxiaomei2002@126.com.'}]",The British journal of ophthalmology,['10.1136/bjophthalmol-2018-313815']
682,31779583,Efficacy and tolerability of sofosbuvir and daclatasvir for treatment of hepatitis C genotype 1 & 3 in patients undergoing hemodialysis- a prospective interventional clinical trial.,"BACKGROUND


There is paucity of data using direct anti-viral agents (DAA) in patients on maintenance hemodialysis (MHD) infected with HCV-genotype 1 & 3. Aim of the study was to evaluate DAA therapy in patients infected with HCV-genotype 1 & 3 on MHD.
METHODS


A prospective open label, parallel, non-randomized interventional trial was conducted in patients with Hepatitis-C on maintenance hemodialysis. Total of Sixty two (62) patients with hepatitis-C on maintenance hemodialysis were screened and 36 patients were enrolled and then equally allocated in 1:1 ratio to group 1 who received 400 mg daily sofosbuvir/ 60 mg daily daclatasvir and group 2 who received thrice a week 400 mg Sofosbuvir and daily 60 mg daclatasvir for 12 weeks. Patients with compensated cirrhosis received therapy for 24 weeks. Relevant data was obtained before, during and after therapy. HCV viral load was assessed at week 4, 8, at end of therapy and 12 weeks after treatment.
RESULTS


Eighteen (18) patients were allocated in each group. Three patients in group 1 withdrawn from the study after 2 weeks due to refusal to participate, while one withdrawn in group 2 due to development of adverse effect. Mean age of patients was 47.22 + 14.17 in group 1 and 53.89 + 14.11 in group 2. Genotype 3 was most common in group 1 patients, n = 12 (66.6%), and n = 11 (61.1%) in group 2. All patients in both groups achieved undetectable viral load at 12th week. As per intention to treat analysis overall 29/36 (80.55%) patients achieved SVR (group 1 = 15/18; group 2 = 14/18) and as per-protocol analysis overall 29/32 (90.62%) patients achieved SVR (group 1 = 15/15; group 2 = 14/17).
CONCLUSION


Direct acting antiviral therapy using sofosbuvir and declatsavir is highly effective and tolerable in patients with HCV genotype 1 & 3 undergoing maintenance hemodialysis, especially when given daily.
TRIAL REGISTRATION


This trial is registered in WHO, International Clinical Trial Registry Platform, through Iranian Registry of Clinical Trials (IRCT) having IRCT ID: IRCT20170614034526N3, registered retrospectively on 2019-03-08.",2019,As per intention to treat analysis overall 29/36 (80.55%) patients achieved SVR (group 1 = 15/18; group 2 = 14/18) and as per-protocol analysis overall 29/32 (90.62%),"['patients infected with HCV-genotype 1 & 3 on MHD', 'patients with Hepatitis-C on maintenance hemodialysis', 'patients with HCV genotype 1 & 3 undergoing maintenance hemodialysis', 'Total of Sixty two (62) patients with hepatitis-C on maintenance hemodialysis were screened and 36 patients', 'Eighteen (18) patients were allocated in each group', 'patients undergoing hemodialysis- a prospective interventional clinical trial', 'patients on maintenance hemodialysis\xa0(MHD) infected with HCV-genotype 1 & 3', 'Patients with compensated cirrhosis received therapy for 24\u2009weeks']","['direct anti-viral agents (DAA', 'sofosbuvir and daclatasvir', '400\u2009mg daily sofosbuvir/ 60\u2009mg daily daclatasvir and group 2 who received thrice a week 400\u2009mg Sofosbuvir and daily 60\u2009mg daclatasvir', 'SVR']","['Efficacy and tolerability', 'HCV viral load']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1285573', 'cui_str': 'Genotype determination'}, {'cui': 'C0019196', 'cui_str': 'Parenterally-Transmitted Non-A, Non-B Hepatitis'}, {'cui': 'C4040576', 'cui_str': 'Maintenance hemodialysis'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517835', 'cui_str': '62 (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C1608426', 'cui_str': 'Compensated cirrhosis'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C2976303', 'cui_str': 'sofosbuvir'}, {'cui': 'C3252090', 'cui_str': 'daclatasvir'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C1868902', 'cui_str': 'HCV viral load'}]",,0.0684156,As per intention to treat analysis overall 29/36 (80.55%) patients achieved SVR (group 1 = 15/18; group 2 = 14/18) and as per-protocol analysis overall 29/32 (90.62%),"[{'ForeName': 'Shafiq Ur Rehman', 'Initials': 'SUR', 'LastName': 'Cheema', 'Affiliation': 'Department of Nephrology Jinnah Hospital & Allama Iqbal Medical College, Lahore, Pakistan. shafiqcheema@yahoo.com.'}, {'ForeName': 'Muhammad Salman', 'Initials': 'MS', 'LastName': 'Rehman', 'Affiliation': 'Department of Gastroenterology Jinnah Hospital & Allama Iqbal Medical College, Lahore, Pakistan.'}, {'ForeName': 'Ghulam', 'Initials': 'G', 'LastName': 'Hussain', 'Affiliation': 'Department of Gastroenterology Jinnah Hospital & Allama Iqbal Medical College, Lahore, Pakistan.'}, {'ForeName': 'Sidra Shafiq', 'Initials': 'SS', 'LastName': 'Cheema', 'Affiliation': 'Combined Military Hospital.L.M.C, Lahore, Pakistan.'}, {'ForeName': 'Nooman', 'Initials': 'N', 'LastName': 'Gilani', 'Affiliation': 'Department of Gastroenterology Jinnah Hospital & Allama Iqbal Medical College, Lahore, Pakistan.'}]",BMC nephrology,['10.1186/s12882-019-1631-4']
683,29773490,Addressing Parents' Vaccine Concerns: A Randomized Trial of a Social Media Intervention.,"INTRODUCTION


Successful strategies are needed to address parental vaccine hesitancy, a significant public health issue. The study objective was to assess whether an Internet-based platform with vaccine information and interactive social media components improved parents' vaccine-related attitudes.
STUDY DESIGN


A three-arm RCT.
SETTING/PARTICIPANTS


The study was conducted in a large Colorado integrated healthcare organization. Parents were enrolled during September 2013 through October 2015 and followed through November 2016; data were analyzed in 2017. Parents, recruited during pregnancy, were given a survey about vaccine-related attitudes at enrollment (i.e., baseline) and when their child was aged 3-5 months and 12-15 months (Timepoints 1 and 2, respectively). Parental vaccine hesitancy was assessed at baseline.
INTERVENTION


Study participants were randomized to the following: a study website with vaccine information and social media components (VSM arm); a website with vaccine information only (VI); or usual care.
MAIN OUTCOME MEASURES


Change in parental vaccine attitudes over time by baseline degree of vaccine hesitancy.
RESULTS


Among 1,093 study participants, 945 (86.5%) completed all three surveys. Comparing baseline with Timepoint 1 among vaccine-hesitant parents, the VSM and VI arms were associated with significant improvements in attitudes regarding vaccination benefits compared to usual care (VSM mean change 0.23 on a 5-point scale, 95% CI=0.05, 0.40, VI mean change 0.22, 95% CI=0.04, 0.40). Comparing baseline with Timepoint 2 among hesitant parents, the VSM and VI arms were also associated with significant reductions in parental concerns about vaccination risks compared to usual care (VSM mean change -0.37, 95% CI= -0.60, -0.14, VI mean change -0.31, 95% CI= -0.55, -0.07). Self-efficacy around vaccine decision making also improved among vaccine-hesitant parents. No intervention effect was observed among parents not vaccine-hesitant at baseline.
CONCLUSIONS


Among vaccine-hesitant parents, an Internet-based intervention improved parents' attitudes about vaccines.
TRIAL REGISTRATION


This study was registered at www.clinicaltrials.gov NCT01873040.",2018,"Comparing baseline with Timepoint 2 among hesitant parents, the VSM and VI arms were also associated with significant reductions in parental concerns about vaccination risks compared to usual care (VSM mean change -0.37, 95% CI= -0.60, -0.14,","[""Addressing Parents' Vaccine Concerns"", ""parents' vaccine-related attitudes"", 'Parents were enrolled during September 2013 through October 2015 and followed through November 2016; data were analyzed in 2017', 'vaccine-hesitant parents', '1,093 study participants, 945 (86.5%) completed all three surveys']","['vaccine information and social media components (VSM arm); a website with vaccine information only (VI); or usual care', 'Social Media Intervention', 'Internet-based platform with vaccine information and interactive social media components']","['Parental vaccine hesitancy', 'attitudes regarding vaccination benefits', 'parental vaccine attitudes over time by baseline degree of vaccine hesitancy', 'parental concerns about vaccination risks']","[{'cui': 'C0376649', 'cui_str': 'Address'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]","[{'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C3179065', 'cui_str': 'Social Media'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0152032', 'cui_str': 'Delay when starting to pass urine (finding)'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",1093.0,0.237998,"Comparing baseline with Timepoint 2 among hesitant parents, the VSM and VI arms were also associated with significant reductions in parental concerns about vaccination risks compared to usual care (VSM mean change -0.37, 95% CI= -0.60, -0.14,","[{'ForeName': 'Matthew F', 'Initials': 'MF', 'LastName': 'Daley', 'Affiliation': 'Institute for Health Research, Kaiser Permanente Colorado, Denver, Colorado; Department of Pediatrics, University of Colorado School of Medicine, Aurora, Colorado. Electronic address: matthew.f.daley@kp.org.'}, {'ForeName': 'Komal J', 'Initials': 'KJ', 'LastName': 'Narwaney', 'Affiliation': 'Institute for Health Research, Kaiser Permanente Colorado, Denver, Colorado.'}, {'ForeName': 'Jo Ann', 'Initials': 'JA', 'LastName': 'Shoup', 'Affiliation': 'Institute for Health Research, Kaiser Permanente Colorado, Denver, Colorado.'}, {'ForeName': 'Nicole M', 'Initials': 'NM', 'LastName': 'Wagner', 'Affiliation': 'Institute for Health Research, Kaiser Permanente Colorado, Denver, Colorado.'}, {'ForeName': 'Jason M', 'Initials': 'JM', 'LastName': 'Glanz', 'Affiliation': 'Institute for Health Research, Kaiser Permanente Colorado, Denver, Colorado; Colorado School of Public Health, University of Colorado Denver, Aurora, Colorado.'}]",American journal of preventive medicine,['10.1016/j.amepre.2018.04.010']
684,31782656,The feasibility of low-intensity psychological therapy for depression co-occurring with autism in adults: The Autism Depression Trial (ADEPT) - a pilot randomised controlled trial.,"Low-intensity cognitive behaviour therapy including behavioural activation is an evidence-based treatment for depression, a condition frequently co-occurring with autism. The feasibility of adapting low-intensity cognitive behaviour therapy for depression to meet the needs of autistic adults via a randomised controlled trial was investigated. The adapted intervention (guided self-help) comprised materials for nine individual sessions with a low-intensity psychological therapist. Autistic adults (n = 70) with depression (Patient Health Questionnaire-9 score ⩾10) recruited from National Health Service adult autism services and research cohorts were randomly allocated to guided self-help or treatment as usual. Outcomes at 10-, 16- and 24-weeks post-randomisation were blind to treatment group. Rates of retention in the study differed by treatment group with more participants attending follow-up in the guided self-help group than treatment as usual. The adapted intervention was well-received, 86% (n = 30/35) of participants attended the pre-defined 'dose' of five sessions of treatment and 71% (25/35) attended all treatment sessions. The findings of this pilot randomised controlled trial indicate that low-intensity cognitive behaviour therapy informed by behavioural activation can be successfully adapted to meet the needs of autistic people. Evaluation of the effectiveness of this intervention in a full scale randomised controlled trial is now warranted.",2020,Rates of retention in the study differed by treatment group with more participants attending follow-up in the guided self-help group than treatment as usual.,"['depression co-occurring with autism in adults', 'autistic adults', 'Autistic adults (n\u2009=\u200970) with depression (Patient Health Questionnaire-9 score ⩾10) recruited from National Health Service adult autism services and research cohorts']","['adapting low-intensity cognitive behaviour therapy', 'adapted intervention (guided self-help) comprised materials for nine individual sessions with a low-intensity psychological therapist', 'low-intensity psychological therapy', 'Low-intensity cognitive behaviour therapy', 'guided self-help or treatment as usual', 'low-intensity cognitive behaviour therapy']",['Rates of retention'],"[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0027462', 'cui_str': 'Health Services, National'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0035168'}]","[{'cui': 'C0596836', 'cui_str': 'Low intensity'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0841584', 'cui_str': 'Psychological therapies (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0035280', 'cui_str': 'Retention'}]",,0.170748,Rates of retention in the study differed by treatment group with more participants attending follow-up in the guided self-help group than treatment as usual.,"[{'ForeName': 'Ailsa', 'Initials': 'A', 'LastName': 'Russell', 'Affiliation': 'University of Bath, UK.'}, {'ForeName': 'Daisy M', 'Initials': 'DM', 'LastName': 'Gaunt', 'Affiliation': 'University of Bristol, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Cooper', 'Affiliation': 'University of Bath, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Barton', 'Affiliation': 'Northumberland, Tyne and Wear NHS Foundation Trust, UK.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Horwood', 'Affiliation': 'University of Bristol, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kessler', 'Affiliation': 'University of Bristol, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Metcalfe', 'Affiliation': 'University of Bristol, UK.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Ensum', 'Affiliation': 'Avon and Wiltshire Mental Health Partnership NHS Trust, UK.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Ingham', 'Affiliation': 'Northumberland, Tyne and Wear NHS Foundation Trust, UK.'}, {'ForeName': 'Jeremy R', 'Initials': 'JR', 'LastName': 'Parr', 'Affiliation': 'Northumberland, Tyne and Wear NHS Foundation Trust, UK.'}, {'ForeName': 'Dheeraj', 'Initials': 'D', 'LastName': 'Rai', 'Affiliation': 'University of Bristol, UK.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Wiles', 'Affiliation': 'University of Bristol, UK.'}]",Autism : the international journal of research and practice,['10.1177/1362361319889272']
685,31622158,Effect of β-alanine supplementation during high-intensity interval training on repeated sprint ability performance and neuromuscular fatigue.,"The study investigated the influence of β-alanine supplementation during a high-intensity interval training (HIIT) program on repeated sprint ability (RSA) performance. This study was randomized, double-blinded, and placebo controlled. Eighteen men performed an incremental running test until exhaustion (T INC ) at baseline and followed by 4-wk HIIT (10 × 1-min runs 90% maximal T INC  velocity [1-min recovery]). Then, participants were randomized into two groups and performed a 6-wk HIIT associated with supplementation of 6.4 g/day of β-alanine (Gβ) or dextrose (placebo group; GP). Pre- and post-6-wk HIIT + supplementation, participants performed the following tests:  1 ) T INC ;  2 ) supramaximal running test; and  3 ) 2 × 6 × 35-m sprints (RSA). Before and immediately after RSA, neuromuscular function was assessed by vertical jumps, maximal isometric voluntary contractions of knee extension, and neuromuscular electrical stimulations. Muscle biopsies were performed to determine muscle carnosine content, muscle buffering capacity in vitro (βm in vitro ), and content of phosphofructokinase (PFK), monocarboxylate transporter 4 (MCT4), and hypoxia-inducible factor-1α (HIF-1α). Both groups showed a significant time effect for maximal oxygen uptake (Gβ: 6.2 ± 3.6% and GP: 6.5 ± 4.2%;  P  > 0.01); only Gβ showed a time effect for total (-3.0 ± 2.0%;  P  = 0.001) and best (-3.3 ± 3.0%;  P  = 0.03) RSA times. A group-by-time interaction was shown after HIIT + Supplementation for muscle carnosine (Gβ: 34.4 ± 2.3 mmol·kg -1 ·dm -1  and GP: 20.7 ± 3.0 mmol·kg -1 ·dm -1 ;  P  = 0.003) and neuromuscular voluntary activation after RSA (Gβ: 87.2 ± 3.3% and GP: 78.9 ± 12.4%;  P  = 0.02). No time effect or group-by-time interaction was shown for supramaximal running test performance, βm, and content of PFK, MCT4, and HIF-1α. In summary, β-alanine supplementation during HIIT increased muscle carnosine and attenuated neuromuscular fatigue, which may contribute to an enhancement of RSA performance. NEW & NOTEWORTHY  β-Alanine supplementation during a high-intensity interval training program increased repeated sprint performance. The improvement of muscle carnosine content induced by β-alanine supplementation may have contributed to an attenuation of central fatigue during repeated sprint. Overall, β-alanine supplementation may be a useful dietary intervention to prevent fatigue.",2019,"No time effect or group-by-time interaction were shown for supramaximal running test performance, βm invitro  and content of PFK,",['Eighteen men'],"['β-alanine supplementation', 'β-Alanine supplementation during a high-intensity interval training (HIIT) program', 'MCT4 and HIF-1α', 'HIIT+Supplementation for muscle carnosine (Gβ', 'placebo', '6-week HIIT associated with supplementation of 6.4g·day -1  of β-Alanine (Gβ) or dextrose (Placebo group; GP']","['neuromuscular voluntary activation', 'neuromuscular function', 'neuromuscular fatigue', 'supramaximal running test performance, βm invitro  and content of PFK', 'repeated sprint ability (RSA) performance', 'vertical jumps, maximal isometric voluntary contractions of knee extension and neuromuscular electrical stimulations', 'muscle carnosine content, muscle buffer capacity  in vitro  ( βm invitro ) and content of phosphofructokinase (PFK), monocarboxylate transporter 4 (MCT4) and hypoxia-inducible factor-1α (HIF-1α', 'repeated sprint ability performance and neuromuscular fatigue', 'time-effect for maximal oxygen uptake']","[{'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0001898', 'cui_str': 'L-alanine'}, {'cui': 'C4277545', 'cui_str': 'High-Intensity Intermittent Exercise'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0007267', 'cui_str': 'Carnosine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0017725', 'cui_str': 'dextrose'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0234116', 'cui_str': 'Neuromuscular fatigue, function (observable entity)'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0205128', 'cui_str': 'Vertical (qualifier value)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C1140999', 'cui_str': 'Contraction (finding)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0013786', 'cui_str': 'Electrical Stimulation'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0007267', 'cui_str': 'Carnosine'}, {'cui': 'C0006353', 'cui_str': 'Buffers'}, {'cui': 'C0021135', 'cui_str': 'In Vitro'}, {'cui': 'C0031651', 'cui_str': '6-Phosphofructokinase'}, {'cui': 'C2316841', 'cui_str': 'Monocarboxylate'}, {'cui': 'C3854146', 'cui_str': 'Transporter (physical object)'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake (observable entity)'}]",,0.276849,"No time effect or group-by-time interaction were shown for supramaximal running test performance, βm invitro  and content of PFK,","[{'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Milioni', 'Affiliation': 'Post Graduate Program in Human Movement Sciences, Laboratory of Physiology and Human Performance, São Paulo State University, Bauru, São Paulo, Brazil.'}, {'ForeName': 'Rodrigo Araújo Bonetti', 'Initials': 'RAB', 'LastName': 'de Poli', 'Affiliation': 'Post Graduate Program in Human Movement Sciences, Laboratory of Physiology and Human Performance, São Paulo State University, Bauru, São Paulo, Brazil.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Saunders', 'Affiliation': 'Applied Physiology and Nutrition Research Group, Faculdade de Medicina da Universidade de São Paul, Rheumatology Division, School of Physical Education and Sport, University of São Paulo, São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Gualano', 'Affiliation': 'Applied Physiology and Nutrition Research Group, Faculdade de Medicina da Universidade de São Paul, Rheumatology Division, School of Physical Education and Sport, University of São Paulo, São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Alisson L', 'Initials': 'AL', 'LastName': 'da Rocha', 'Affiliation': 'School of Physical Education and Sports of Ribeirão Preto, University of São Paulo, Ribeirão Preto, São Paulo, Brazil.'}, {'ForeName': 'Adelino', 'Initials': 'A', 'LastName': 'Sanchez Ramos da Silva', 'Affiliation': 'School of Physical Education and Sports of Ribeirão Preto, University of São Paulo, Ribeirão Preto, São Paulo, Brazil.'}, {'ForeName': 'Paulo de Tarso Guerrero', 'Initials': 'PTG', 'LastName': 'Muller', 'Affiliation': 'Laboratory of Respiratory Pathophysiology, Mato Grosso do Sul Federal University, Campo Grande, Mato Grosso do Sul, São Paulo, Brazil.'}, {'ForeName': 'Alessandro Moura', 'Initials': 'AM', 'LastName': 'Zagatto', 'Affiliation': 'Post Graduate Program in Human Movement Sciences, Laboratory of Physiology and Human Performance, São Paulo State University, Bauru, São Paulo, Brazil.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00321.2019']
686,31218531,Effects of computerized cognitive training as add-on treatment to stimulants in ADHD: a pilot fMRI study.,"The neurofunctional effects of Cognitive training (CT) are poorly understood. Our main objective was to assess fMRI brain activation patterns in children with ADHD who received CT as an add-on treatment to stimulant medication. We included twenty children with ADHD from a clinical trial of stimulant medication and CT (10 in medication + CT and 10 in medication + non-active training). Between-group differences were assessed in performance and in brain activation during 3 fMRI paradigms of working memory (N-back: 0-back, 1-back, 2-back, 3-back), sustained attention (Sustained Attention Task - SAT: 2 s, 5 s and 8 s delays) and inhibitory control (Go/No-Go). We found significant group x time x condition interactions in working memory (WM) and sustained attention on brain activation. In N-back, decreases were observed in the BOLD signal change from baseline to endpoint with increasing WM load in the right insula, right putamen, left thalamus and left pallidum in the CT compared to the non-active group; in SAT - increases in the BOLD signal change from baseline to endpoint with increasing delays were observed in bilateral precuneus, right insula, bilateral associative visual cortex and angular gyrus, right middle temporal, precentral, postcentral, superior frontal and middle frontal gyri in the CT compared to the non-active group. CT in ADHD was associated with changes in activation in task-relevant parietal and striato-limbic regions of sustained attention and working memory. Changes in brain activity may precede behavioral performance modifications in working memory and sustained attention, but not in inhibitory control.",2020,CT in ADHD was associated with changes in activation in task-relevant parietal and striato-limbic regions of sustained attention and working memory.,"['children with ADHD who received', 'ADHD', 'twenty children with ADHD from a clinical trial of stimulant medication and CT (10 in medication + CT and 10 in medication + non-active training']","['CT', 'computerized cognitive training', 'Cognitive training (CT', 'inhibitory control (Go']","['working memory (N-back: 0-back, 1-back, 2-back, 3-back), sustained attention (Sustained Attention Task - SAT: 2\xa0s, 5\xa0s and', 'fMRI brain activation patterns', 'working memory (WM) and sustained attention on brain activation', 'performance and in brain activation', 'BOLD signal change', 'bilateral precuneus, right insula, bilateral associative visual cortex and angular gyrus, right middle temporal, precentral, postcentral, superior frontal and middle frontal gyri']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0242977', 'cui_str': 'Stimulants, Historical'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0589099', 'cui_str': 'Sustained attention, function (observable entity)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0021640', 'cui_str': 'Insula of Reil'}, {'cui': 'C0042817', 'cui_str': 'Visual Cortex'}, {'cui': 'C0152305', 'cui_str': 'Prelunate Gyrus'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0442043', 'cui_str': 'Temporal (qualifier value)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0205123', 'cui_str': 'Coronal (qualifier value)'}, {'cui': 'C0152297', 'cui_str': 'Middle frontal gyrus'}]",20.0,0.0320557,CT in ADHD was associated with changes in activation in task-relevant parietal and striato-limbic regions of sustained attention and working memory.,"[{'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'de Oliveira Rosa', 'Affiliation': 'Postgraduate Program in Psychiatry and Behavioral Sciences, Federal University of Rio Grande do Sul (UFRGS), Porto Alegre, Brazil. virginia.orosa@gmail.com.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Rosa Franco', 'Affiliation': 'Center for Biomedical Imaging and Neuromodulation, The Nathan S. Kline Institute for Psychiatric Research, Orangeburg, NY, USA.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Abrahão Salum Júnior', 'Affiliation': 'ADHD Outpatient Program, Hospital de Clinicas de Porto Alegre, Department of Psychiatry, Federal University of Rio Grande do Sul, Serviço de Psiquiatria. Ramiro Barcelos, 2350. Bairro Santa Cecília, Porto Alegre, RS, CEP: 90035-903, Brazil.'}, {'ForeName': 'Carlos Renato', 'Initials': 'CR', 'LastName': 'Moreira-Maia', 'Affiliation': 'ADHD Outpatient Program, Hospital de Clinicas de Porto Alegre, Department of Psychiatry, Federal University of Rio Grande do Sul, Serviço de Psiquiatria. Ramiro Barcelos, 2350. Bairro Santa Cecília, Porto Alegre, RS, CEP: 90035-903, Brazil.'}, {'ForeName': 'Flávia', 'Initials': 'F', 'LastName': 'Wagner', 'Affiliation': 'ADHD Outpatient Program, Hospital de Clinicas de Porto Alegre, Department of Psychiatry, Federal University of Rio Grande do Sul, Serviço de Psiquiatria. Ramiro Barcelos, 2350. Bairro Santa Cecília, Porto Alegre, RS, CEP: 90035-903, Brazil.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Simioni', 'Affiliation': 'Postgraduate Program in Psychiatry and Behavioral Sciences, Federal University of Rio Grande do Sul (UFRGS), Porto Alegre, Brazil.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'de Fraga Bassotto', 'Affiliation': 'ADHD Outpatient Program, Hospital de Clinicas de Porto Alegre, Department of Psychiatry, Federal University of Rio Grande do Sul, Serviço de Psiquiatria. Ramiro Barcelos, 2350. Bairro Santa Cecília, Porto Alegre, RS, CEP: 90035-903, Brazil.'}, {'ForeName': 'Guilherme', 'Initials': 'G', 'LastName': 'R Moritz', 'Affiliation': 'ADHD Outpatient Program, Hospital de Clinicas de Porto Alegre, Department of Psychiatry, Federal University of Rio Grande do Sul, Serviço de Psiquiatria. Ramiro Barcelos, 2350. Bairro Santa Cecília, Porto Alegre, RS, CEP: 90035-903, Brazil.'}, {'ForeName': 'Cristiano', 'Initials': 'C', 'LastName': 'Schaffer Aguzzoli', 'Affiliation': 'Hospital São Lucas, Pontifical Catholic University of Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Augusto', 'Initials': 'A', 'LastName': 'Buchweitz', 'Affiliation': 'BraIns, Brain Institute of Rio Grande do Sul, Pontifical Catholic University of Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Schmitz', 'Affiliation': 'ADHD Outpatient Program, Hospital de Clinicas de Porto Alegre, Department of Psychiatry, Federal University of Rio Grande do Sul, Serviço de Psiquiatria. Ramiro Barcelos, 2350. Bairro Santa Cecília, Porto Alegre, RS, CEP: 90035-903, Brazil.'}, {'ForeName': 'Katya', 'Initials': 'K', 'LastName': 'Rubia', 'Affiliation': ""Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Luis Augusto', 'Initials': 'LA', 'LastName': 'Paim Rohde', 'Affiliation': 'ADHD Outpatient Program, Hospital de Clinicas de Porto Alegre, Department of Psychiatry, Federal University of Rio Grande do Sul, Serviço de Psiquiatria. Ramiro Barcelos, 2350. Bairro Santa Cecília, Porto Alegre, RS, CEP: 90035-903, Brazil.'}]",Brain imaging and behavior,['10.1007/s11682-019-00137-0']
687,31786121,"Atezolizumab plus nab-paclitaxel as first-line treatment for unresectable, locally advanced or metastatic triple-negative breast cancer (IMpassion130): updated efficacy results from a randomised, double-blind, placebo-controlled, phase 3 trial.","BACKGROUND


Immunotherapy in combination with chemotherapy has shown promising efficacy across many different tumour types. We report the prespecified second interim overall survival analysis of the phase 3 IMpassion130 study assessing the efficacy and safety of atezolizumab plus nab-paclitaxel in patients with unresectable, locally advanced or metastatic triple-negative breast cancer.
METHODS


In this randomised, placebo-controlled, double-blind, phase 3 trial, done in 246 academic centres and community oncology practices in 41 countries, patients aged 18 years or older, with previously untreated, histologically documented, locally advanced or metastatic triple-negative breast cancer, and Eastern Cooperative Oncology Group performance status of 0 or 1 were eligible. Patients were randomly assigned (1:1) using a permuted block method (block size of four) and an interactive voice-web response system. Randomisation was stratified by previous taxane use, liver metastases, and PD-L1 expression on tumour-infiltrating immune cells. Patients received atezolizumab 840 mg or matching placebo intravenously on day 1 and day 15 of every 28-day cycle and nab-paclitaxel 100 mg/m 2  of body surface area intravenously on days 1, 8, and 15 until progression or unacceptable toxicity. Investigators, patients, and the funder were masked to treatment assignment. Coprimary endpoints were investigator-assessed progression-free survival per Response Evaluation Criteria in Solid Tumors version 1.1 and overall survival, assessed in the intention-to-treat population and in patients with PD-L1 immune cell-positive tumours (tumours with ≥1% PD-L1 expression). The final progression-free survival results were previously reported at the first interim overall survival analysis. The prespecified statistical testing hierarchy meant that overall survival in the subgroup of PD-L1 immune cell-positive patients could only be formally tested if overall survival was significantly different between the treatment groups in the intention-to-treat population. This study is registered with ClinicalTrials.gov, NCT02425891.
FINDINGS


Between June 23, 2015, and May 24, 2017, 902 patients were enrolled, of whom 451 were randomly assigned to receive atezolizumab plus nab-paclitaxel and 451 were assigned to receive placebo plus nab-paclitaxel (the intention-to-treat population). Six patients from each group did not receive treatment. At the second interim analysis (data cutoff Jan 2, 2019), median follow-up was 18·5 months (IQR 9·6-22·8) in the atezolizumab group and 17·5 months (8·4-22·4) in the placebo group. Median overall survival in the intention-to-treat patients was 21·0 months (95% CI 19·0-22·6) with atezolizumab and 18·7 months (16·9-20·3) with placebo (stratified hazard ratio [HR] 0·86, 95% CI 0·72-1·02, p=0·078). In the exploratory overall survival analysis in patients with PD-L1 immune cell-positive tumours, median overall survival was 25·0 months (95% CI 19·6-30·7) with atezolizumab versus 18·0 months (13·6-20·1) with placebo (stratified HR 0·71, 0·54-0·94]). As of Sept 3, 2018 (the date up to which updated safety data were available), the most common grade 3-4 adverse events were neutropenia (38 [8%] of 453 patients in the atezolizumab group vs 36 [8%] of 437 patients in the placebo group), peripheral neuropathy (25 [6%] vs 12 [3%]), decreased neutrophil count (22 [5%] vs 16 [4%]), and fatigue (17 [4%] vs 15 [3%]). Treatment-related deaths occurred in two (<1%) patients in the atezolizumab group (autoimmune hepatitis related to atezolizumab [n=1] and septic shock related to nab-paclitaxel [n=1]) and one (<1%) patient in the placebo group (hepatic failure). No new treatment-related deaths have been reported since the primary clinical data cutoff date (April 17, 2018).
INTERPRETATION


Consistent with the first interim analysis, this second interim overall survival analysis of IMpassion130 indicates no significant difference in overall survival between the treatment groups in the intention-to-treat population but suggests a clinically meaningful overall survival benefit with atezolizumab plus nab-paclitaxel in patients with PD-L1 immune cell-positive disease. However, this positive result could not be formally tested due to the prespecified statistical testing hierarchy. For patients with PD-L1 immune cell-positive metastatic triple-negative breast cancer, atezolizumab plus nab-paclitaxel is an important therapeutic option in a disease with high unmet need.
FUNDING


F Hoffmann-La Roche and Genentech.",2020,Treatment-related deaths occurred in two (<1%) patients in the atezolizumab group (autoimmune hepatitis related to atezolizumab [n=1] and septic shock related to nab-paclitaxel [n=1]) and one (<1%) patient in the placebo group (hepatic failure).,"['patients with unresectable, locally advanced or metastatic triple-negative breast cancer', 'Between June 23, 2015, and May 24, 2017, 902 patients were enrolled, of whom 451', 'unresectable, locally advanced or metastatic triple-negative breast cancer (IMpassion130', 'patients with PD-L1 immune cell-positive metastatic triple-negative breast cancer', 'patients with PD-L1 immune cell-positive disease', '246 academic centres and community oncology practices in 41 countries, patients aged 18 years or older, with previously untreated, histologically documented, locally advanced or metastatic triple-negative breast cancer, and Eastern Cooperative Oncology Group performance status of 0 or 1 were eligible']","['atezolizumab plus nab-paclitaxel', 'atezolizumab', 'Atezolizumab plus nab-paclitaxel', 'placebo', 'permuted block method (block size of four) and an interactive voice-web response system', 'placebo plus nab-paclitaxel', 'atezolizumab 840 mg or matching placebo']","['peripheral neuropathy', 'investigator-assessed progression-free survival per Response Evaluation Criteria in Solid Tumors version 1.1 and overall survival', 'efficacy and safety', 'septic shock', 'overall survival', 'median overall survival', 'neutropenia', 'Median overall survival', 'neutrophil count', 'deaths', 'fatigue', 'final progression-free survival results']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C3539878', 'cui_str': 'Triple Negative Breast Cancer'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}]","[{'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C4708913', 'cui_str': '840'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0031117', 'cui_str': 'PNS (Peripheral Nervous System) Diseases'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C4517491', 'cui_str': 'One point one'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0036983', 'cui_str': 'Septic Shock'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0200633', 'cui_str': 'Neutrophil count (procedure)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",902.0,0.735947,Treatment-related deaths occurred in two (<1%) patients in the atezolizumab group (autoimmune hepatitis related to atezolizumab [n=1] and septic shock related to nab-paclitaxel [n=1]) and one (<1%) patient in the placebo group (hepatic failure).,"[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Schmid', 'Affiliation': 'Barts Cancer Institute, Queen Mary University of London, London, UK. Electronic address: p.schmid@qmul.ac.uk.'}, {'ForeName': 'Hope S', 'Initials': 'HS', 'LastName': 'Rugo', 'Affiliation': 'University of California San Francisco Comprehensive Cancer Center, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Adams', 'Affiliation': 'Perlmutter Cancer Center, New York University Langone Medical Center, New York, NY, USA.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Schneeweiss', 'Affiliation': 'National Center for Tumor Diseases, Heidelberg University Hospital and German Cancer Research Center, Heidelberg, Germany.'}, {'ForeName': 'Carlos H', 'Initials': 'CH', 'LastName': 'Barrios', 'Affiliation': 'Centro de Pesquisa Clínica, Hospital São Lucas, Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, Brazil; Latin American Cooperative Oncology Group, Porto Alegre, Brazil; Grupo Oncoclínicas, Porto Alegre, Brazil.'}, {'ForeName': 'Hiroji', 'Initials': 'H', 'LastName': 'Iwata', 'Affiliation': 'Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Diéras', 'Affiliation': 'Department of Medical Oncology, Institut Curie, Paris, France; Department of Medical Oncology, Centre Eugène Marquis, Rennes, France.'}, {'ForeName': 'Volkmar', 'Initials': 'V', 'LastName': 'Henschel', 'Affiliation': 'F Hoffmann-La Roche, Basel, Switzerland.'}, {'ForeName': 'Luciana', 'Initials': 'L', 'LastName': 'Molinero', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Stephen Y', 'Initials': 'SY', 'LastName': 'Chui', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Vidya', 'Initials': 'V', 'LastName': 'Maiya', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Amreen', 'Initials': 'A', 'LastName': 'Husain', 'Affiliation': 'F Hoffmann-La Roche, Basel, Switzerland.'}, {'ForeName': 'Eric P', 'Initials': 'EP', 'LastName': 'Winer', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Sherene', 'Initials': 'S', 'LastName': 'Loi', 'Affiliation': 'Peter MacCallum Cancer Centre, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Leisha A', 'Initials': 'LA', 'LastName': 'Emens', 'Affiliation': 'University of Pittsburgh Medical Center Hillman Cancer Center, Pittsburgh, PA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30689-8']
688,31779715,Post-moderate-intensity exercise energy replacement does not reduce subsequent appetite and energy intake in adolescents with obesity.,"Exercise modifies energy intake (EI) in adolescents with obesity, but whether this is mediated by the exercise-induced energy deficit remains unknown. The present study examined the effect of exercise with and without dietary replacement of the exercise energy expenditure on appetite, EI and food reward in adolescents with obesity. Fourteen 12-15-year-old adolescents with obesity (eight girls; Tanner 3-4; BMI 34·8 (sd 5·7) kg/m2; BMI z score 2·3 (sd 0·4)) randomly completed three experimental conditions: (i) rest control (CON); (ii) 30-min cycling (EX) and (iii) 30-min cycling with dietary energy replacement (EX + R). Ad libitum EI was assessed at lunch and dinner, and food reward (Leeds Food Preference Questionnaire) before and after lunch. Appetite was assessed at regular intervals. Lunch, evening and total EI (excluding the post-exercise snack in EX - R) were similar across conditions. Lunch and total EI including the post-exercise snack in EX + R were higher in EX - R than CON and EX; EX and CON were similar. Total relative EI was lower in EX (6284 (sd 2042) kJ) compared with CON (7167 (sd 2218) kJ; P < 0·05) and higher in EX + R (7736 (sd 2033) kJ) compared with CON (P < 0·001). Appetite and satiety quotients did not differ across conditions (P ≥ 0·10). Pre-meal explicit liking for fat was lower in EX compared with CON and EX + R (P = 0·05). There was time by condition interaction between EX and CON for explicit wanting and liking for fat (P = 0·01). Despite similar appetite and EI, adolescents with obesity do not adapt their post-exercise food intake to account for immediate dietary replacement of the exercise-induced energy deficit, favouring a short-term positive energy balance.",2020,meal explicit liking for fat was lower in EX compared to CON and EX+R (p=0.05).,"['Fourteen 12-15 years adolescents with obesity (8girls; Tanner3-4', 'adolescents with obesity']","['Post- moderate intensity exercise energy replacement', 'rest control (CON); ii) 30-min cycling (EX); iii) 30-min cycling with dietary energy replacement (EX+R', 'exercise with and without dietary replacement of the exercise energy expenditure', 'Exercise modifies energy intake']","['Appetite and satiety quotients', 'Appetite', 'subsequent appetite and energy intake', 'meal explicit liking for fat', 'Ad libitum energy intake (EI', 'Lunch, evening and total EI', 'Total relative EI']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0014272', 'cui_str': 'Energy Expenditure'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}]","[{'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C0036239', 'cui_str': 'Satiations'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C4552032', 'cui_str': 'With lunch'}, {'cui': 'C0587117', 'cui_str': 'Evening (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}]",,0.0396199,meal explicit liking for fat was lower in EX compared to CON and EX+R (p=0.05).,"[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Thivel', 'Affiliation': 'Laboratory of the Metabolic Adaptations to Exercise under Physiological and Pathological Conditions (AME2P), Clermont Auvergne University, EA 3533, Clermont-Ferrand, France.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Roche', 'Affiliation': 'Laboratory of the Metabolic Adaptations to Exercise under Physiological and Pathological Conditions (AME2P), Clermont Auvergne University, EA 3533, Clermont-Ferrand, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Miguet', 'Affiliation': 'Laboratory of the Metabolic Adaptations to Exercise under Physiological and Pathological Conditions (AME2P), Clermont Auvergne University, EA 3533, Clermont-Ferrand, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Fillon', 'Affiliation': 'Laboratory of the Metabolic Adaptations to Exercise under Physiological and Pathological Conditions (AME2P), Clermont Auvergne University, EA 3533, Clermont-Ferrand, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Khammassi', 'Affiliation': 'Laboratory of the Metabolic Adaptations to Exercise under Physiological and Pathological Conditions (AME2P), Clermont Auvergne University, EA 3533, Clermont-Ferrand, France.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Beaulieu', 'Affiliation': 'Faculty of Medicine and Health, School of Psychology, University of Leeds, LeedsLS2 9JT, UK.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Finlayson', 'Affiliation': 'Faculty of Medicine and Health, School of Psychology, University of Leeds, LeedsLS2 9JT, UK.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Pereira', 'Affiliation': 'Clermont-Ferrand University Hospital, Biostatistics Unit (DRCI), 63000, Clermont-Ferrand, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Miyashita', 'Affiliation': 'Faculty of Sport Sciences, Waseda University, Saitama169-0051, Japan.'}, {'ForeName': 'A E', 'Initials': 'AE', 'LastName': 'Thackray', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport, Exercise and Health Sciences, Loughborough University, LeicestershireLE11 3TU, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Masurier', 'Affiliation': 'UGECAM Nutrition Obesity Ambulatory Hospital, 63000, Clermont-Ferrand, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Duclos', 'Affiliation': 'Centre de Recherche en Nutrition Humaine (CRNH)-Auvergne, 63000 Clermont-Ferrand, France.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Boirie', 'Affiliation': 'Centre de Recherche en Nutrition Humaine (CRNH)-Auvergne, 63000 Clermont-Ferrand, France.'}]",The British journal of nutrition,['10.1017/S0007114519003106']
689,31699728,Usefulness of applying research reporting guidelines as Writing Aid software: a crossover randomised controlled trial.,"OBJECTIVES


To assess the intention of using a Writing Aid software, which integrates four research reporting guidelines (Consolidated Standards of Reporting Trials, Preferred Reporting Items for Systematic Reviews and Meta-Analyses, Strengthening the Reporting of Observational Studies in Epidemiology and STrengthening the Reporting of Observational Studies in Epidemiology-nutritional epidemiology) and their Elaboration & Explanation (E&E) documents during the write-up of research in Microsoft Word compared with current practices.
DESIGN


Two-arms crossover randomised controlled trial with no blinding and no washout period.
SETTING


Face-to-face or online sessions.
PARTICIPANTS


54 (28 in arm 1 and 26 in arm 2) doctoral and postdoctoral researchers.
INTERVENTIONS


Reporting guidelines and their E&E document were randomly administered as Writing Aid or as Word documents in a single 30 min to 1 hour session, with a short break before crossing over to the other study intervention.
PRIMARY AND SECONDARY OUTCOMES


Using the Technology Acceptance Model, we assessed the primary outcome: the difference in the mean of intention of use; and secondary outcomes: the difference in mean perceived ease of use and perceived usefulness. The three outcomes were measured using questions with a 7-point Likert-scale. Secondary analysis using structural equation modelling (SEM) was applied to explore the relationships between the outcomes.
RESULTS


No significant difference in reported intention of use (mean difference and 95% CI 0.25 (-0.05 to 0.55), p=0.10), and perceived usefulness (mean difference and 95% CI 0.19 (-0.04 to 0.41), p=0.10). The Writing Aid performed significantly better than the word document on researchers' perceived ease of use (mean difference and 95% CI 0.59 (0.29 to 0.89), p<0.001). In the SEM analysis, participants' intention of using the tools was indirectly affected by perceived ease of use (beta 0.53 p = 0.002).
CONCLUSIONS


Despite no significant difference in the intention of use between the tools, administering reporting guidelines as Writing Aid is perceived as easier to use, offering a possibility to further explore its applicability to enhance reporting adherence.",2019,"The Writing Aid performed significantly better than the word document on researchers' perceived ease of use (mean difference and 95% CI 0.59 (0.29 to 0.89), p<0.001).",['54 (28 in arm 1 and 26 in arm 2) doctoral and postdoctoral researchers'],[],['mean of intention of use; and secondary outcomes: the difference in mean perceived ease of use and perceived usefulness'],"[{'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}]",,0.122449,"The Writing Aid performed significantly better than the word document on researchers' perceived ease of use (mean difference and 95% CI 0.59 (0.29 to 0.89), p<0.001).","[{'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Hawwash', 'Affiliation': 'Department of Food Technology, Safety and Health, Ghent University, Gent, Belgium.'}, {'ForeName': 'Melissa K', 'Initials': 'MK', 'LastName': 'Sharp', 'Affiliation': 'Department of Psychology, University of Split, Split, Croatia.'}, {'ForeName': 'Alemayehu', 'Initials': 'A', 'LastName': 'Argaw', 'Affiliation': 'Department of Population and Family Health, Institute of Health, Jimma University, Jimma, Ethiopia.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Kolsteren', 'Affiliation': 'Department of Food Technology, Safety and Health, Ghent University, Gent, Belgium.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Lachat', 'Affiliation': 'Department of Food Technology, Safety and Health, Ghent University, Gent, Belgium carl.lachat@ugent.be.'}]",BMJ open,['10.1136/bmjopen-2019-030943']
690,31729973,Vitamin e-loaded membrane dialyzers reduce hemodialysis inflammaging.,"BACKGROUND


Inflammaging is a persistent, low-grade, sterile, nonresolving inflammatory state, associated with the senescence of the immune system. Such condition downregulates both innate and adaptive immune responses during chronic disorders as type II diabetes, cancer and hemodialysis, accounting for their susceptibility to infections, malignancy and resistance to vaccination. Aim of this study was to investigate hemodialysis inflammaging, by evaluating changes of several hemodialysis treatments on indoleamine 2,3-dioxygenase-1 activity and nitric oxide formation.
METHODS


We conducted a randomized controlled observational crossover trial. Eighteen hemodialysis patients were treated with 3 different hemodialysis procedures respectively: 1) Low-flux bicarbonate hemodialysis, 2) Low-flux bicarbonate hemodialysis with vitamin E - loaded dialyzers, and 3) Hemodialfitration. The control group consisted of 14 hospital staff healthy volunteers. Blood samples were collected from all 18 hemodialysis patients just after the long interdialytic interval, at the end of each hemodialysis treatment period.
RESULTS


Hemodialysis kynurenine and kynurenine/L - tryptophan blood ratio levels were significantly higher, when compared to the control group, indicating an increased indoleamine 2,3-dioxygenase-1 activity in hemodialysis patients. At the end of the low-flux bicarbonate hemodialysis with vitamin E - loaded dialyzers period, L - tryptophan serum levels remained unchanged vs both low-flux bicarbonate hemodialysis and hemodialfitration. Kynurenine levels instead decreased, resulting in a significant reduction of kynurenine/L - tryptophan blood ratio and indoleamine 2,3-dioxygenase-1 activity, when matched to both low-flux bicarbonate hemodialysis and HDF respectively. Serum nitric oxide control group levels, were significantly lower when compared to all hemodialysis patient groups. Interestingly, low-flux bicarbonate hemodialysis with vitamin E - loaded dialyzers nitric oxide serum levels from venous line blood samples taken 60 min after starting the hemodialysis session were significantly lower vs serum taken simultaneously from the arterial blood line.
CONCLUSIONS


The treatment with more biocompatible hemodialysis procedure as low-flux bicarbonate hemodialysis with vitamin E - loaded dialyzers, reduced indoleamine 2,3-dioxygenase-1 activity and nitric oxide formation when compared to both low-flux bicarbonate hemodialysis and hemodialfitration. These data suggest that low-flux bicarbonate hemodialysis with vitamin E - loaded dialyzers lowering hemodialysis inflammaging, could be associated to changes of proinflammatory signalling a regulated molecular level.
TRIAL REGISTRATION


NCT Number: NCT02981992; Other Study ID Numbers: 20100014090. First submitted: November 26, 2016. First posted: December 5, 2016. Last Update Posted: December 5, 2016.",2019,"tryptophan blood ratio levels were significantly higher, when compared to the control group, indicating an increased indoleamine 2,3-dioxygenase-1 activity in hemodialysis patients.","['14 hospital staff healthy volunteers', 'hemodialysis patients', 'Eighteen hemodialysis patients', 'Hemodialysis kynurenine and kynurenine/L\u2009']","['Low-flux bicarbonate hemodialysis, 2) Low-flux bicarbonate hemodialysis with vitamin E\u2009-\u2009loaded dialyzers, and 3) Hemodialfitration', 'Vitamin e-loaded membrane dialyzers']","['indoleamine 2,3-dioxygenase-1 activity', 'kynurenine/L\u2009-\u2009tryptophan blood ratio and indoleamine 2,3-dioxygenase-1 activity', 'indoleamine 2,3-dioxygenase-1 activity and nitric oxide formation', 'Serum nitric oxide control group levels', 'Blood samples', 'Kynurenine levels', 'tryptophan blood ratio levels']","[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0022818', 'cui_str': 'Benzenebutanoic acid, alpha,2-diamino-gamma-oxo-'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0005367', 'cui_str': 'Hydrogen Carbonates'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0025255', 'cui_str': 'Membranes'}]","[{'cui': 'C1564138', 'cui_str': 'Indoleamine-Pyrrole 2,3,-Dioxygenase'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0022818', 'cui_str': 'Benzenebutanoic acid, alpha,2-diamino-gamma-oxo-'}, {'cui': 'C0041249', 'cui_str': 'L-tryptophan'}, {'cui': 'C0005768'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}]",,0.0140031,"tryptophan blood ratio levels were significantly higher, when compared to the control group, indicating an increased indoleamine 2,3-dioxygenase-1 activity in hemodialysis patients.","[{'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Sepe', 'Affiliation': 'Unit of Nephrology and Dialysis, Transplantation; Fondazione IRCCS Policlinico «San Matteo», Viale Camillo Golgi 19, 27100, Pavia, Italy. v.sepe@smatteo.pv.it.'}, {'ForeName': 'Marilena', 'Initials': 'M', 'LastName': 'Gregorini', 'Affiliation': 'Unit of Nephrology and Dialysis, Transplantation; Fondazione IRCCS Policlinico «San Matteo», Viale Camillo Golgi 19, 27100, Pavia, Italy.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Rampino', 'Affiliation': 'Unit of Nephrology and Dialysis, Transplantation; Fondazione IRCCS Policlinico «San Matteo», Viale Camillo Golgi 19, 27100, Pavia, Italy.'}, {'ForeName': 'Pasquale', 'Initials': 'P', 'LastName': 'Esposito', 'Affiliation': 'Unit of Nephrology and Dialysis, Transplantation; Fondazione IRCCS Policlinico «San Matteo», Viale Camillo Golgi 19, 27100, Pavia, Italy.'}, {'ForeName': 'Rosanna', 'Initials': 'R', 'LastName': 'Coppo', 'Affiliation': 'Fondazione Ricerca Molinette, Regina Margherita Hospital 94, Piazza Polonia, 10126, Torino, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Galli', 'Affiliation': 'Università degli Studi di Perugia, Pharmaceutical Sciences, Branch of Via del Giochetto, building B, 2nd floor, 06123, Perugia, Italy.'}, {'ForeName': 'Carmelo', 'Initials': 'C', 'LastName': 'Libetta', 'Affiliation': 'Unit of Nephrology and Dialysis, Transplantation; Fondazione IRCCS Policlinico «San Matteo», Viale Camillo Golgi 19, 27100, Pavia, Italy.'}]",BMC nephrology,['10.1186/s12882-019-1585-6']
691,31104507,Efficacy of galcanezumab in patients with chronic migraine and a history of preventive treatment failure.,"BACKGROUND


Efficacy of galcanezumab in chronic migraine has been demonstrated in a pivotal Phase 3 study. Here, we assess efficacy in patients who have failed ≥2 and ≥1 prior migraine preventives for efficacy and/or safety reasons, and in those who never failed.
STUDY DESIGN/METHODS


REGAIN (NCT02614261) was a Phase 3, randomized, double-blind, placebo-controlled study in patients with chronic migraine. Patients were randomized 2:1:1 to receive placebo, galcanezumab 120 mg/240 mg once monthly during a double-blind treatment period lasting three months. Subgroup analyses were conducted among patients who failed ≥2 and ≥1 prior preventives and who never failed previously. Outcomes assessed were change from baseline in number of monthly migraine headache days, proportion of patients with ≥50% and ≥75% response (reduction in monthly migraine headache days), change in number of monthly migraine headache days with acute medication use and change in patient functioning per Migraine-Specific Quality of Life Questionnaire Role Function Restrictive (MSQ RF-R) domain score.
RESULTS


Treatment with galcanezumab versus placebo resulted in significant improvements ( p  < 0.01) in overall reduction (Months 1-3) from baseline in the number of monthly migraine headache days in patients with prior failures (LS mean change [SE]: ≥2 prior failures: galcanezumab 120 mg: -5.35 (0.71); galcanezumab 240 mg: -2.77 (0.66); placebo: -1.01 (0.54); ≥1 prior failures: galcanezumab 120 mg: -5.53 (0.60), galcanezumab 240 mg: -3.53 (0.59); placebo: -2.02 (0.49). Similarly, significant results were seen with galcanezumab versus placebo for ≥50% and ≥75% response rates, reductions in acute medication use and improvements in MSQ RF-R domain score. In the subgroup with no prior preventive failures, results were statistically significant for the 240 mg galcanezumab group versus placebo on all outcome measures, and for the 120 mg group on the reduction in migraine headache days with acute medication use. There was also a higher placebo response observed in the patients with no prior preventive failures.
CONCLUSION


Galcanezumab is consistently efficacious versus placebo in reducing monthly migraine headache days and several other key outcomes in patients with chronic migraine who have failed ≥2 or ≥1 preventives previously. In the subgroup with no prior failures, greater numerical differences were seen with galcanezumab, but statistical separation from placebo varied by dose and outcome.
CLINICALTRIALS.GOV IDENTIFIER NUMBER


NCT02614261.",2019,"RESULTS


Treatment with galcanezumab versus placebo resulted in significant improvements ( p  < 0.01) in overall reduction (Months 1-3) from baseline in the number of monthly migraine headache days in patients with prior failures (LS mean change [SE]: ≥2 prior failures: galcanezumab 120 mg: -5.35 (0.71); galcanezumab 240 mg: -2.77 (0.66); placebo: -1.01 (0.54); ≥1 prior failures: galcanezumab 120 mg: -5.53 (0.60), galcanezumab 240 mg: -3.53 (0.59); placebo: -2.02 (0.49).","['patients with chronic migraine and a history of preventive treatment failure', 'patients with chronic migraine who have failed ≥2 or ≥1 preventives previously', 'patients who have failed ≥2 and ≥1 prior migraine preventives for efficacy and/or safety reasons, and in those who never failed', 'patients with chronic migraine', 'patients who failed ≥2 and ≥1 prior preventives and who never failed previously']","['Galcanezumab', 'placebo', 'galcanezumab', 'galcanezumab versus placebo', 'placebo, galcanezumab']","['placebo response', 'number of monthly migraine headache days', 'migraine headache days', 'overall reduction', 'number of monthly migraine headache days, proportion of patients with ≥50% and ≥75% response (reduction in monthly migraine headache days), change in number of monthly migraine headache days with acute medication use and change in patient functioning per Migraine-Specific Quality of Life Questionnaire Role Function Restrictive (MSQ RF-R) domain score', 'acute medication use and improvements in MSQ RF-R domain score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1960870', 'cui_str': 'Chronic migraine'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C1456501', 'cui_str': 'Preventive'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0684328', 'cui_str': 'Reasoning'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0034380'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.190411,"RESULTS


Treatment with galcanezumab versus placebo resulted in significant improvements ( p  < 0.01) in overall reduction (Months 1-3) from baseline in the number of monthly migraine headache days in patients with prior failures (LS mean change [SE]: ≥2 prior failures: galcanezumab 120 mg: -5.35 (0.71); galcanezumab 240 mg: -2.77 (0.66); placebo: -1.01 (0.54); ≥1 prior failures: galcanezumab 120 mg: -5.53 (0.60), galcanezumab 240 mg: -3.53 (0.59); placebo: -2.02 (0.49).","[{'ForeName': 'Dustin D', 'Initials': 'DD', 'LastName': 'Ruff', 'Affiliation': '1 Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Janet H', 'Initials': 'JH', 'LastName': 'Ford', 'Affiliation': '1 Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Antje', 'Initials': 'A', 'LastName': 'Tockhorn-Heidenreich', 'Affiliation': '2 Eli Lilly and Company, Erl Wood Manor, Windlesham, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Sexson', 'Affiliation': '1 Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Sriram', 'Initials': 'S', 'LastName': 'Govindan', 'Affiliation': '3 Eli Lilly Services India Private Limited, Bengaluru, Karnataka, India.'}, {'ForeName': 'Eric M', 'Initials': 'EM', 'LastName': 'Pearlman', 'Affiliation': '4 Lilly USA, LLC, Indianapolis, IN, USA.'}, {'ForeName': 'Shuu-Jiun', 'Initials': 'SJ', 'LastName': 'Wang', 'Affiliation': '5 Brain Research Center, National Yang-Ming University, Taipei.'}, {'ForeName': 'Arif', 'Initials': 'A', 'LastName': 'Khan', 'Affiliation': '7 Northwest Clinical Research Center, Bellevue, WA, USA.'}, {'ForeName': 'Sheena K', 'Initials': 'SK', 'LastName': 'Aurora', 'Affiliation': '1 Eli Lilly and Company, Indianapolis, IN, USA.'}]",Cephalalgia : an international journal of headache,['10.1177/0333102419847957']
692,31679946,"Efficacy and safety of the elexacaftor plus tezacaftor plus ivacaftor combination regimen in people with cystic fibrosis homozygous for the F508del mutation: a double-blind, randomised, phase 3 trial.","BACKGROUND


Cystic fibrosis transmembrane conductance regulator (CFTR) modulators correct the basic defect caused by CFTR mutations. Improvements in health outcomes have been achieved with the combination of a CFTR corrector and potentiator in people with cystic fibrosis homozygous for the F508del mutation. The addition of elexacaftor (VX-445), a next-generation CFTR corrector, to tezacaftor plus ivacaftor further improved F508del-CFTR function and clinical outcomes in a phase 2 study in people with cystic fibrosis homozygous for the F508del mutation.
METHODS


This phase 3, multicentre, randomised, double-blind, active-controlled trial of elexacaftor in combination with tezacaftor plus ivacaftor was done at 44 sites in four countries. Eligible participants were those with cystic fibrosis homozygous for the F508del mutation, aged 12 years or older with stable disease, and with a percentage predicted forced expiratory volume in 1 s (ppFEV 1 ) of 40-90%, inclusive. After a 4-week tezacaftor plus ivacaftor run-in period, participants were randomly assigned (1:1) to 4 weeks of elexacaftor 200 mg orally once daily plus tezacaftor 100 mg orally once daily plus ivacaftor 150 mg orally every 12 h versus tezacaftor 100 mg orally once daily plus ivacaftor 150 mg orally every 12 h alone. The primary outcome was the absolute change from baseline (measured at the end of the tezacaftor plus ivacaftor run-in) in ppFEV 1  at week 4. Key secondary outcomes were absolute change in sweat chloride and Cystic Fibrosis Questionnaire-Revised respiratory domain (CFQ-R RD) score. This study is registered with ClinicalTrials.gov, NCT03525548.
FINDINGS


Between Aug 3 and Dec 28, 2018, 113 participants were enrolled. Following the run-in, 107 participants were randomly assigned (55 in the elexacaftor plus tezacaftor plus ivacaftor group and 52 in the tezacaftor plus ivacaftor group) and completed the 4-week treatment period. The elexacaftor plus tezacaftor plus ivacaftor group had improvements in the primary outcome of ppFEV 1  (least squares mean [LSM] treatment difference of 10·0 percentage points [95% CI 7·4 to 12·6], p<0·0001) and the key secondary outcomes of sweat chloride concentration (LSM treatment difference -45·1 mmol/L [95% CI -50·1 to -40·1], p<0·0001), and CFQ-R RD score (LSM treatment difference 17·4 points [95% CI 11·8 to 23·0], p<0·0001) compared with the tezacaftor plus ivacaftor group. The triple combination regimen was well tolerated, with no discontinuations. Most adverse events were mild or moderate; serious adverse events occurred in two (4%) participants receiving elexacaftor plus tezacaftor plus ivacaftor and in one (2%) receiving tezacaftor plus ivacaftor.
INTERPRETATION


Elexacaftor plus tezacaftor plus ivacaftor provided clinically robust benefit compared with tezacaftor plus ivacaftor alone, with a favourable safety profile, and shows the potential to lead to transformative improvements in the lives of people with cystic fibrosis who are homozygous for the F508del mutation.
FUNDING


Vertex Pharmaceuticals.",2019,Improvements in health outcomes have been achieved with the combination of a CFTR corrector and potentiator in people with cystic fibrosis homozygous for the F508del mutation.,"['107 participants were randomly assigned (55 in the', 'Between Aug 3 and Dec 28, 2018, 113 participants were enrolled', 'Eligible participants were those with cystic fibrosis homozygous for the F508del mutation, aged 12 years or older with stable disease, and with a percentage predicted forced expiratory volume in 1 s (ppFEV 1 ) of 40-90%, inclusive', 'people with cystic fibrosis homozygous for the F508del mutation', 'people with cystic fibrosis who are homozygous for the F508del mutation']","['elexacaftor plus tezacaftor plus ivacaftor group and 52 in the tezacaftor plus ivacaftor', 'elexacaftor', 'tezacaftor plus ivacaftor', 'elexacaftor (VX-445', 'elexacaftor 200 mg orally once daily plus tezacaftor 100 mg orally once daily plus ivacaftor 150 mg orally every 12 h versus tezacaftor 100 mg orally once daily plus ivacaftor', 'elexacaftor plus tezacaftor plus ivacaftor combination regimen']","['adverse events', 'ppFEV 1  (least squares mean [LSM] treatment difference of 10·0 percentage points', 'Efficacy and safety', 'sweat chloride concentration (LSM treatment difference -45·1 mmol/L', 'absolute change in sweat chloride and Cystic Fibrosis Questionnaire-Revised respiratory domain (CFQ-R RD) score', 'CFQ-R RD score']","[{'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0010674', 'cui_str': 'Mucoviscidosis'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4519194', 'cui_str': 'tezacaftor'}, {'cui': 'C3264621', 'cui_str': 'ivacaftor'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C4550902', 'cui_str': 'tezacaftor 100 MG'}, {'cui': 'C3264622', 'cui_str': 'ivacaftor 150 MG'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0023189', 'cui_str': 'Least Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0428295', 'cui_str': 'Cystic fibrosis sweat test (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1532563', 'cui_str': 'umol/mL'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0010674', 'cui_str': 'Mucoviscidosis'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",113.0,0.337851,Improvements in health outcomes have been achieved with the combination of a CFTR corrector and potentiator in people with cystic fibrosis homozygous for the F508del mutation.,"[{'ForeName': 'Harry G M', 'Initials': 'HGM', 'LastName': 'Heijerman', 'Affiliation': 'Department of Pulmonology, University Medical Center Utrecht, Utrecht, Netherlands. Electronic address: h.g.m.heijerman@umcutrecht.nl.'}, {'ForeName': 'Edward F', 'Initials': 'EF', 'LastName': 'McKone', 'Affiliation': ""St Vincent's University Hospital and University College Dublin School of Medicine, Dublin, Ireland.""}, {'ForeName': 'Damian G', 'Initials': 'DG', 'LastName': 'Downey', 'Affiliation': ""Centre for Experimental Medicine, Queen's University Belfast, Belfast, UK.""}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Van Braeckel', 'Affiliation': 'Department of Respiratory Medicine, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Rowe', 'Affiliation': 'Division of Pulmonary, Allergy, and Critical Care Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Tullis', 'Affiliation': ""Division of Respirology, St Michael's Hospital, University of Toronto, Toronto, ON, Canada.""}, {'ForeName': 'Marcus A', 'Initials': 'MA', 'LastName': 'Mall', 'Affiliation': 'Department of Pulmonology, Immunology and Intensive Care Medicine, Charité-Universitätsmedizin Berlin, Berlin, Germany; Berlin Institute of Health, Berlin, Germany; German Center for Lung Research, Berlin, Germany.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Welter', 'Affiliation': 'Division of Pediatric Pulmonology, Allergy, Immunology, and Sleep Medicine, New York Medical College, Valhalla, NY, USA.'}, {'ForeName': 'Bonnie W', 'Initials': 'BW', 'LastName': 'Ramsey', 'Affiliation': ""Department of Pediatrics, Seattle Children's Hospital, University of Washington School of Medicine, Seattle, WA, USA.""}, {'ForeName': 'Charlotte M', 'Initials': 'CM', 'LastName': 'McKee', 'Affiliation': 'Vertex Pharmaceuticals, Boston, MA, USA.'}, {'ForeName': 'Gautham', 'Initials': 'G', 'LastName': 'Marigowda', 'Affiliation': 'Vertex Pharmaceuticals, Boston, MA, USA.'}, {'ForeName': 'Samuel M', 'Initials': 'SM', 'LastName': 'Moskowitz', 'Affiliation': 'Vertex Pharmaceuticals, Boston, MA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Waltz', 'Affiliation': 'Vertex Pharmaceuticals, Boston, MA, USA.'}, {'ForeName': 'Patrick R', 'Initials': 'PR', 'LastName': 'Sosnay', 'Affiliation': 'Vertex Pharmaceuticals, Boston, MA, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Simard', 'Affiliation': 'Vertex Pharmaceuticals, Boston, MA, USA.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Ahluwalia', 'Affiliation': 'Vertex Pharmaceuticals, Boston, MA, USA.'}, {'ForeName': 'Fengjuan', 'Initials': 'F', 'LastName': 'Xuan', 'Affiliation': 'Vertex Pharmaceuticals, Boston, MA, USA.'}, {'ForeName': 'Yaohua', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Vertex Pharmaceuticals, Boston, MA, USA.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Taylor-Cousar', 'Affiliation': 'Department of Medicine and Pediatrics, National Jewish Health, Denver, CO, USA.'}, {'ForeName': 'Karen S', 'Initials': 'KS', 'LastName': 'McCoy', 'Affiliation': ""Department of Pediatrics, Nationwide Children's Hospital, Ohio State University, Columbus, OH, USA.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(19)32597-8']
693,31768724,Simulator training and residents' first laparoscopic hysterectomy: a randomized controlled trial.,"BACKGROUND


Hysterectomy rates are decreasing in many countries, and virtual reality simulators bring new opportunities into residents' surgical education. The objective of this study was to evaluate the effect of training in laparoscopic hysterectomy module with virtual reality simulator on surgical outcomes among residents performing their first laparoscopic hysterectomy.
METHODS


This randomized study was carried out at the Department of Obstetrics and Gynecology in Helsinki University Hospital and Hyvinkää Hospital. We recruited twenty residents and randomly signed half of them to train ten times with the laparoscopic hysterectomy module on a virtual reality simulator, while the rest represented the control group. Their first laparoscopic hysterectomy was video recorded and assessed later by using the Objective Structured Assessment of Technical Skills (OSATS) forms and Visual Analog Scale (VAS). The scores and surgical outcomes were compared between the groups.
RESULTS


The mean OSATS score for the Global Rating Scale (GRS) was 17.0 (SD 3.1) in the intervention group and 11.2 (SD 2.4) in the control group (p = 0.002). The mean procedure-specific OSATS score was 20.0 (SD 3.3) and 16.0 (SD 2.8) (p = 0.012), and the mean VAS score was 55.0 (SD 14.8) and 29.9 (SD 14.9) (p = 0.001). Operative time was 144 min in the intervention group and 165 min in the control group, but the difference did not reach statistical significance (p = 0.205). There were no differences between the groups in blood loss or direct complications.
CONCLUSION


Residents training with a virtual reality simulator prior to the first laparoscopic hysterectomy seem to perform better in the actual live operation. Thus, a virtual reality simulator hysterectomy module could be considered as a part of laparoscopic training curriculum.",2020,"Operative time was 144 min in the intervention group and 165 min in the control group, but the difference did not reach statistical significance (p = 0.205).","['Department of Obstetrics and Gynecology in Helsinki University Hospital and Hyvinkää Hospital', 'residents performing their first laparoscopic hysterectomy']","[""Simulator training and residents' first laparoscopic hysterectomy"", 'laparoscopic hysterectomy module on a virtual reality simulator, while the rest represented the control group', 'laparoscopic hysterectomy module with virtual reality simulator']","['mean procedure-specific OSATS score', 'Operative time', 'Objective Structured Assessment of Technical Skills (OSATS) forms and Visual Analog Scale (VAS', 'blood loss or direct complications', 'scores and surgical outcomes', 'surgical outcomes', 'mean VAS score', 'mean OSATS score for the Global Rating Scale (GRS']","[{'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0404089', 'cui_str': 'Laparoscopic hysterectomy (procedure)'}]","[{'cui': 'C0183309', 'cui_str': 'Simulator (physical object)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0404089', 'cui_str': 'Laparoscopic hysterectomy (procedure)'}, {'cui': 'C3542953', 'cui_str': 'Module (core metadata concept)'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0222045'}]",20.0,0.0636844,"Operative time was 144 min in the intervention group and 165 min in the control group, but the difference did not reach statistical significance (p = 0.205).","[{'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Jokinen', 'Affiliation': 'Obstetrics and Gynecology, University of Helsinki and Helsinki University Hospital, Haartmaninkatu 2, P.O. Box 140, 00029 HUS, Helsinki, Finland. ewa.jokinen@hus.fi.'}, {'ForeName': 'Tomi S', 'Initials': 'TS', 'LastName': 'Mikkola', 'Affiliation': 'Obstetrics and Gynecology, University of Helsinki and Helsinki University Hospital, Haartmaninkatu 2, P.O. Box 140, 00029 HUS, Helsinki, Finland.'}, {'ForeName': 'Päivi', 'Initials': 'P', 'LastName': 'Härkki', 'Affiliation': 'Obstetrics and Gynecology, University of Helsinki and Helsinki University Hospital, Haartmaninkatu 2, P.O. Box 140, 00029 HUS, Helsinki, Finland.'}]",Surgical endoscopy,['10.1007/s00464-019-07270-3']
694,31669447,Serum 25-hydroxyvitamin D in the VITamin D and OmegA-3 TriaL (VITAL): Clinical and demographic characteristics associated with baseline and change with randomized vitamin D treatment.,"BACKGROUND


The VITamin D and OmegA-3 TriaL (VITAL) is a completed randomized, placebo-controlled trial of vitamin D 3  (2000 IU/day) and marine omega-3 (1 g/day) supplements in the primary prevention of cancer and cardiovascular disease. Here we examine baseline and change in 25-hydroxyvitamin D (25(OH)D) and related biomarkers with randomized treatment and by clinical factors.
METHODS


Baseline 25(OH)D was measured in 15,804 participants (mean age 68 years.; 50.8% women; 15.7% African Americans) and in 1660 1-year follow-up samples using liquid chromatography-tandem mass spectrometry and chemiluminescence. Calcium and parathyroid hormone (iPTH) were measured by chemiluminescence and spectrophotometry respectively.
RESULTS


Mean baseline total 25(OH)D (ng/mL ± SD) was 30.8 ± 10.0 ng/mL, and correlated inversely with iPTH (r = -0.28), p < .001. After adjusting for clinical factors, 25(OH)D (ng/mL ± SE) was lower in men vs women (29.7 ± 0.30 vs 31.4 ± 0.30, p < .0001) and in African Americans vs whites (27.9 ± 0.29 vs 32.5 ± 0.22, p < .0001). It was also lower with increasing BMI, smoking, and latitude, and varied by season. Mean 1-year 25(OH)D increased by 11.9 ng/mL in the active group and decreased by 0.7 ng/mL in placebo. The largest increases were noted among individuals with low baseline and African Americans. Results were similar for chemiluminescent immunoassay. Mean calcium was unchanged, and iPTH decreased with treatment.
CONCLUSION


In VITAL, baseline 25(OH)D varied by clinical subgroups, was lower in men and African Americans. Concentrations increased with vitamin D supplementation, with the greatest increases in those with lower baseline 25(OH)D. The seasonal trends in 25(OH)D, iPTH, and calcium may be relevant when interpreting 25(OH)D levels for clinical treatment decisions.
CLINICAL TRIAL REGISTRATION


VITAL ClinicalTrials.gov number NCT01169259.",2019,Mean 1-year 25(OH)D increased by 11.9 ng/mL in the active group and decreased by 0.7 ng/mL in placebo.,"['15,804 participants (mean age 68\u202fyears', 'number', 'individuals with low baseline and African Americans']","['vitamin D supplementation', 'placebo', 'marine omega-3', 'VITamin D and OmegA-3 TriaL', 'vitamin D']","['total 25(OH)D (ng/mL\u202f±\u202fSD', 'BMI, smoking, and latitude, and varied by season', 'Mean 1-year 25(OH)D', 'Calcium and parathyroid hormone (iPTH', '25-hydroxyvitamin D (25(OH)D', 'Serum 25-hydroxyvitamin D', 'Mean calcium']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0524645', 'cui_str': 'Marines'}, {'cui': 'C1719844', 'cui_str': 'Greek letter omega'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0030520', 'cui_str': 'Parathyroid Hormone'}, {'cui': 'C0047008', 'cui_str': 'IPTHS'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]",,0.470621,Mean 1-year 25(OH)D increased by 11.9 ng/mL in the active group and decreased by 0.7 ng/mL in placebo.,"[{'ForeName': 'Heike', 'Initials': 'H', 'LastName': 'Luttmann-Gibson', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, 900 Commonwealth Avenue, Boston, MA 02215, USA; Department of Environmental Health, Harvard T.H. Chan School of Public Health, Landmark Center West, 401 Park Drive, Boston, MA 02215, USA.""}, {'ForeName': 'Samia', 'Initials': 'S', 'LastName': 'Mora', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, 900 Commonwealth Avenue, Boston, MA 02215, USA; Division of Cardiovascular Medicine and Center for Lipid Metabolomics, Brigham and Women's Hospital, Harvard Medical School, 900 Commonwealth Avenue, Boston, MA 02215, USA. Electronic address: smora@bwh.harvard.edu.""}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Camargo', 'Affiliation': 'Department of Emergency Medicine, Massachusetts General Hospital, Harvard Medical School, 55 Fruit Street, Boston, MA 02114, USA; Channing Division of Network Medicine, Department of Medicine, Harvard Medical School, 75 Francis Street, Boston, MA 02115, USA; Department of Epidemiology, Harvard T.H. Chan School of Public Health, 677 Huntington Avenue, Boston, MA 02115, USA.'}, {'ForeName': 'Nancy R', 'Initials': 'NR', 'LastName': 'Cook', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, 900 Commonwealth Avenue, Boston, MA 02215, USA; Department of Epidemiology, Harvard T.H. Chan School of Public Health, 677 Huntington Avenue, Boston, MA 02115, USA.""}, {'ForeName': 'Olga V', 'Initials': 'OV', 'LastName': 'Demler', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, 900 Commonwealth Avenue, Boston, MA 02215, USA.""}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Ghoshal', 'Affiliation': 'Quest Diagnostics, 27027 Tourney Road, Valencia, CA 91355, USA.'}, {'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Wohlgemuth', 'Affiliation': 'Quest Diagnostics, 27027 Tourney Road, Valencia, CA 91355, USA.'}, {'ForeName': 'Kris', 'Initials': 'K', 'LastName': 'Kulkarni', 'Affiliation': 'Atherotech Diagnostics, 201 London Pkwy #400, Birmingham, AL 35211, USA; VAP Diagnostics R&D Laboratory, 201 London Pkwy, Birmingham, AL 3521, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Larsen', 'Affiliation': 'Quest Diagnostics, 27027 Tourney Road, Valencia, CA 91355, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Prentice', 'Affiliation': 'Quest Diagnostics, 27027 Tourney Road, Valencia, CA 91355, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Cobble', 'Affiliation': 'Atherotech Diagnostics, 201 London Pkwy #400, Birmingham, AL 35211, USA.'}, {'ForeName': 'Vadim', 'Initials': 'V', 'LastName': 'Bubes', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, 900 Commonwealth Avenue, Boston, MA 02215, USA.""}, {'ForeName': 'Chunying', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, 900 Commonwealth Avenue, Boston, MA 02215, USA.""}, {'ForeName': 'Georgina', 'Initials': 'G', 'LastName': 'Friedenberg', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, 900 Commonwealth Avenue, Boston, MA 02215, USA.""}, {'ForeName': 'I-Min', 'Initials': 'IM', 'LastName': 'Lee', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, 900 Commonwealth Avenue, Boston, MA 02215, USA; Department of Epidemiology, Harvard T.H. Chan School of Public Health, 677 Huntington Avenue, Boston, MA 02115, USA.""}, {'ForeName': 'Julie E', 'Initials': 'JE', 'LastName': 'Buring', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, 900 Commonwealth Avenue, Boston, MA 02215, USA; Department of Epidemiology, Harvard T.H. Chan School of Public Health, 677 Huntington Avenue, Boston, MA 02115, USA.""}, {'ForeName': 'JoAnn E', 'Initials': 'JE', 'LastName': 'Manson', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, 900 Commonwealth Avenue, Boston, MA 02215, USA; Department of Epidemiology, Harvard T.H. Chan School of Public Health, 677 Huntington Avenue, Boston, MA 02115, USA.""}]",Contemporary clinical trials,['10.1016/j.cct.2019.105854']
695,31166697,Safety findings from Phase 3 lasmiditan studies for acute treatment of migraine: Results from SAMURAI and SPARTAN.,"BACKGROUND


We assessed the safety profile of lasmiditan, a selective 5-HT 1F  receptor agonist without vasoconstrictive activity being developed as an acute therapy for migraine.
METHODS


SAMURAI and SPARTAN were Phase 3 double-blind studies of patients with migraine, randomized to oral lasmiditan 50 mg (SPARTAN only), 100 mg, 200 mg, or placebo to be taken within 4 hours of onset of migraine pain. Safety data from the studies were integrated. Treatment-emergent adverse events (occurring within 48 hours of first dose) were considered in the analyses.
RESULTS


The safety population comprised 1262 patients assigned placebo, and 654, 1265, and 1258 assigned lasmiditan 50 mg, 100 mg, and 200 mg, respectively. There were no deaths; serious adverse events were reported for seven patients (placebo, n = 2 [0.2%]; lasmiditan 50 mg, n = 1 [0.2%]; lasmiditan 100 mg, n = 1 [0.2%]; lasmiditan 200 mg, n = 3 [0.2%]). Patients reporting ≥ 1 treatment-emergent adverse events were: Placebo, n = 174 (13.5%); lasmiditan 50 mg, n = 166 (25.4%); lasmiditan 100 mg, n = 458 (36.2%); and lasmiditan 200 mg, n = 510 (40.6%). Treatment-emergent adverse events were generally mild or moderate in severity. The most common treatment-emergent adverse events with lasmiditan were dizziness, paresthesia, somnolence, fatigue, nausea, muscular weakness and hypoesthesia. There were no ischemic events.
CONCLUSIONS


As a centrally-penetrant drug, lasmiditan use was associated with neurologic treatment-emergent adverse events; most were mild or moderate in severity and self-limiting.
TRIAL REGISTRATION AT CLINICALTRIALS.GOV


SAMURAI (NCT02439320) and SPARTAN (NCT02605174).",2019,"There were no deaths; serious adverse events were reported for seven patients (placebo, n = 2 [0.2%]; lasmiditan 50 mg, n = 1 [0.2%]; lasmiditan 100 mg, n = 1 [0.2%]; lasmiditan 200 mg, n = 3 [0.2%]).","['Patients reporting\u2009≥', '1262 patients assigned', 'patients with migraine', 'acute treatment of migraine']","['Placebo', 'placebo', 'oral lasmiditan 50\u2009mg (SPARTAN only), 100\u2009mg, 200\u2009mg, or placebo']","['dizziness, paresthesia, somnolence, fatigue, nausea, muscular weakness and hypoesthesia', 'ischemic events', 'deaths; serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0030554', 'cui_str': 'Paresthesia'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0151786', 'cui_str': 'Muscular Weakness'}, {'cui': 'C0020580', 'cui_str': 'Reduced Sensation'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.317753,"There were no deaths; serious adverse events were reported for seven patients (placebo, n = 2 [0.2%]; lasmiditan 50 mg, n = 1 [0.2%]; lasmiditan 100 mg, n = 1 [0.2%]; lasmiditan 200 mg, n = 3 [0.2%]).","[{'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Krege', 'Affiliation': '1 Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Paul B', 'Initials': 'PB', 'LastName': 'Rizzoli', 'Affiliation': ""2 Brigham and Women's Faulkner Hospital, Boston, MA, USA.""}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Liffick', 'Affiliation': '1 Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Erin G', 'Initials': 'EG', 'LastName': 'Doty', 'Affiliation': '1 Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Sherie A', 'Initials': 'SA', 'LastName': 'Dowsett', 'Affiliation': '1 Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Jianing', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': '1 Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Andrew S', 'Initials': 'AS', 'LastName': 'Buchanan', 'Affiliation': '1 Eli Lilly and Company, Indianapolis, IN, USA.'}]",Cephalalgia : an international journal of headache,['10.1177/0333102419855080']
696,31784436,Moving 2 Mindful  (M2M) study protocol: testing a mindfulness group plus ecological momentary intervention to decrease stress and anxiety in adolescents from high-conflict homes with a mixed-method longitudinal design.,"INTRODUCTION


Interparental conflict exposure places adolescents at risk for problems with stress and anxiety; existing prevention/intervention strategies focus on reducing interparental conflict. Mindfulness-based programmes may be a promising treatment strategy for this population, but studies have not yet tested whether they are effective in this high-conflict context. In addition, evidence suggests that extensions to traditional treatments, such as delivering components in daily life that are tailored to moments of need, can increase treatment efficacy, particularly when combined with in-person treatments and particularly for adolescents. However, there are no such extensions to mindfulness interventions available. The  Moving 2 Mindful  study aims to (1) develop an ecological momentary intervention (EMI) supplement to Learning to BREATHE (L2B), an evidence-based mindfulness intervention for adolescents; (2) refine the EMI programme and determine the best delivery plan; (3) examine the feasibility and acceptability of L2B Plus (L2B plus the developed supplement) and (4) examine the potential for L2B Plus to reduce stress and anxiety for adolescents from high-conflict homes.
METHODS AND ANALYSIS


The  Moving 2 Mindful  study proposes a mixed-methods approach to developing and refining a multimethod adaptive supplement to L2B. Feasibility, acceptability and potential effectiveness will be tested in a sample of 38 families, who will be randomly assigned to receive L2B Plus or an active health and wellness control condition and followed until 3 months postintervention. A range of psychosocial and physiological factors will be assessed at multiple time points. This study is registered with clinicaltrials.gov (ID NCT03869749; pre-results).
ETHICS AND DISSEMINATION


The Institutional Review Board at Colorado State University has approved this study. Findings will be disseminated in scientific journals and conferences, whether they are positive, negative or inconclusive.",2019,"Mindfulness-based programmes may be a promising treatment strategy for this population, but studies have not yet tested whether they are effective in this high-conflict context.","['adolescents from high-conflict homes', 'Interparental conflict exposure places adolescents at risk for problems with stress and anxiety', 'adolescents from high-conflict homes with a mixed-method longitudinal design', 'sample of 38 families']","['L2B', 'mindfulness group plus ecological momentary intervention', 'ecological momentary intervention (EMI) supplement to Learning to BREATHE (L2B), an evidence-based mindfulness intervention', 'Plus (L2B plus the developed supplement) and (4) examine the potential for L2B']","['stress and anxiety', 'interparental conflict', 'feasibility and acceptability of L2B']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0009671', 'cui_str': 'Conflict'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C1955961', 'cui_str': 'Interparental Conflict'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0015576', 'cui_str': 'Family'}]","[{'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1955961', 'cui_str': 'Interparental Conflict'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",38.0,0.121243,"Mindfulness-based programmes may be a promising treatment strategy for this population, but studies have not yet tested whether they are effective in this high-conflict context.","[{'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Lucas-Thompson', 'Affiliation': 'Human Development and Family Studies, Colorado State University College of Health and Human Sciences, Fort Collins, Colorado, USA Lucas-thompson.rachel.graham@colostate.edu.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Seiter', 'Affiliation': 'Human Development and Family Studies, Colorado State University College of Health and Human Sciences, Fort Collins, Colorado, USA.'}, {'ForeName': 'Patricia C', 'Initials': 'PC', 'LastName': 'Broderick', 'Affiliation': 'Biobehavioral Health & Medicine, Pennsylvania State University, University Park, Pennsylvania, USA.'}, {'ForeName': 'James Douglas', 'Initials': 'JD', 'LastName': 'Coatsworth', 'Affiliation': 'Human Development and Family Studies, Colorado State University College of Health and Human Sciences, Fort Collins, Colorado, USA.'}, {'ForeName': 'Kimberly L', 'Initials': 'KL', 'LastName': 'Henry', 'Affiliation': 'Psychology, Colorado State University, Fort Collins, Colorado, USA.'}, {'ForeName': 'Charlotte J', 'Initials': 'CJ', 'LastName': 'McKernan', 'Affiliation': 'Human Development and Family Studies, Colorado State University College of Health and Human Sciences, Fort Collins, Colorado, USA.'}, {'ForeName': 'Joshua M', 'Initials': 'JM', 'LastName': 'Smyth', 'Affiliation': 'Biobehavioral Health & Medicine, Pennsylvania State University, University Park, Pennsylvania, USA.'}]",BMJ open,['10.1136/bmjopen-2019-030948']
697,30693660,"Preventive effects of carbon dioxide laser and casein phosphopeptide amorphous calcium phosphate fluoride varnish on enamel demineralization: A comparative, in vitro study.","AIM


The aim of the present study was to compare the effects of carbon dioxide (CO 2  ) laser and casein phosphopeptide amorphous calcium phosphate (CPP-ACP)fluoride varnish on enamel demineralization.
METHODS


Human teeth were randomly assigned to three groups. The enamel was treated with fluoride varnish, 10.6 μm CO 2  laser, or no treatment (control), followed by 9 days of pH cycling. Baseline and final FluoreCam images were used to quantify the area, intensity, and impact of demineralization; cross-sectional microhardness was used to measure the mechanical properties of the enamel.
RESULTS


There were statistically-significant changes in the area, intensity and impact of demineralization in the control and laser groups (P < 0.05), but not in the fluoride group. The control group showed a significantly greater area and impact of enamel demineralization compared to the fluoride group. The area of demineralization in the laser group was significantly greater than that of the fluoride group. Enamel demineralization of the laser and control groups was comparable. The fluoride group showed statistically-significant harder enamel than the control at 20, 40, and 60 μm depths; the laser group enamel was significantly harder than the control at 20 and 40 μm depths. The fluoride group showed statistically-significant harder enamel than the laser group at 20 μm depth.
CONCLUSIONS


CPP-ACP fluoride varnish is more effective than CO 2  in preventing enamel demineralization.",2019,"There were statistically-significant changes in the area, intensity and impact of demineralization in the control and laser groups (P < 0.05), but not in the fluoride group.",['Human teeth'],"['fluoride varnish, 10.6\xa0μm CO 2  laser, or no treatment (control', 'carbon dioxide laser and casein phosphopeptide amorphous calcium phosphate fluoride varnish', 'CPP-ACP fluoride varnish', 'carbon dioxide (CO 2  ) laser and casein phosphopeptide amorphous calcium phosphate (CPP-ACP)fluoride varnish', 'fluoride']","['statistically-significant harder enamel', 'Enamel demineralization', 'area of demineralization', 'area, intensity and impact of demineralization', 'enamel demineralization', 'area and impact of enamel demineralization']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0040426', 'cui_str': 'Tooth'}]","[{'cui': 'C0016326', 'cui_str': 'Fluoride Varnishes'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0392251', 'cui_str': 'CO2 Lasers'}, {'cui': 'C0007332', 'cui_str': 'Caseins'}, {'cui': 'C0031684', 'cui_str': 'Phosphopeptides'}, {'cui': 'C1956739', 'cui_str': 'Ca9(PO4)6'}, {'cui': 'C1120338', 'cui_str': 'casein phosphopeptide-amorphous calcium phosphate nanocomplex'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0047123', 'cui_str': 'CPP'}, {'cui': 'C0042359', 'cui_str': 'Varnish'}, {'cui': 'C0016327', 'cui_str': 'Fluorides'}]","[{'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0018599', 'cui_str': 'Hardness'}, {'cui': 'C0011350', 'cui_str': 'Enamel'}, {'cui': 'C0700185', 'cui_str': 'Demineralized structure'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}]",,0.0250957,"There were statistically-significant changes in the area, intensity and impact of demineralization in the control and laser groups (P < 0.05), but not in the fluoride group.","[{'ForeName': 'Moufida', 'Initials': 'M', 'LastName': 'Abufarwa', 'Affiliation': 'Department of Biomedical Science, Texas A&M University College of Dentistry, Dallas, Texas.'}, {'ForeName': 'Amal', 'Initials': 'A', 'LastName': 'Noureldin', 'Affiliation': 'Department of Public Health Sciences, Texas A&M University College of Dentistry, Dallas, Texas.'}, {'ForeName': 'Taha', 'Initials': 'T', 'LastName': 'Azimaie', 'Affiliation': 'Rutgers School of Dental Medicine, Newark, New Jersey.'}, {'ForeName': 'Phillip M', 'Initials': 'PM', 'LastName': 'Campbell', 'Affiliation': 'Department of Orthodontics, Texas A&M University College of Dentistry, Dallas, Texas.'}, {'ForeName': 'Peter H', 'Initials': 'PH', 'LastName': 'Buschang', 'Affiliation': 'Department of Orthodontics, Texas A&M University College of Dentistry, Dallas, Texas.'}]",Journal of investigative and clinical dentistry,['10.1111/jicd.12400']
698,31240998,The differential influence of computerized neuropsychological assessment across psychopathology.,"Objective:  Novel technologies have transformed neuropsychological test administration so that research examining the equivalency of computerized versions of traditional tests is needed. This study examined the relationship between psychological symptom severity and performance on the Wisconsin Card Sorting Test (WCST) using the manual versus computerized administration. Method:  Eighty-five participants were randomly assigned to the manual or computerized WCST administration and also completed the Dot Counting Test, Depression Anxiety Stress Scales, and Short UPPS-P Impulsive Behavior Scale. Moderation analyses examined the effects of depressive, anxiety, and impulsivity symptom severity on WCST performance. Results:  For Perseverative Responses (PR), the methods of administration (MOAs) were equivalent regardless of psychological symptom severity. For failures to maintain set (FMS), MOA itself influenced performance, with participants making at least twice as many FMS on the computerized WCST. MOA also significantly moderated the relationship between FMS and impulsivity severity, including Lack of Perseverance, Sensation Seeking, and Positive Urgency. Individuals with greater Positive Urgency made more FMS on the manual WCST, and individuals with greater Lack of Perseverance made more FMS on the computerized WCST. Conclusions:  Findings suggest that equivalence between the manual and computerized versions of the WCST depends on the WCST subscale and the type of psychological symptom. New normative data need to be developed for the computerized WCST, along with a more consistent method of scoring and interpreting WCST subscales.",2020,"Individuals with greater Positive Urgency made more FMS on the manual WCST, and individuals with greater Lack of Perseverance made more FMS on the computerized WCST.  ",['Method:  Eighty-five participants'],"['manual or computerized WCST', 'Wisconsin Card Sorting Test (WCST) using the manual versus computerized administration']","['depressive, anxiety, and impulsivity symptom severity on WCST performance', 'FMS and impulsivity severity, including Lack of Perseverance, Sensation Seeking, and Positive Urgency', 'Results:  For Perseverative Responses (PR), the methods of administration (MOAs', 'Dot Counting Test, Depression Anxiety Stress Scales, and Short UPPS-P Impulsive Behavior Scale', 'WCST subscale and the type of psychological symptom']","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C4517892', 'cui_str': '85'}]","[{'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0043193', 'cui_str': 'Wisconsin'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0021125', 'cui_str': 'Impulsivity'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0332268', 'cui_str': 'Lacking (qualifier value)'}, {'cui': 'C0036658', 'cui_str': 'Sensory Function'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C1720485', 'cui_str': 'Corneal epithelial microcysts'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0222045'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0233397', 'cui_str': 'Psychological symptom'}]",85.0,0.0192767,"Individuals with greater Positive Urgency made more FMS on the manual WCST, and individuals with greater Lack of Perseverance made more FMS on the computerized WCST.  ","[{'ForeName': 'Shifali M', 'Initials': 'SM', 'LastName': 'Singh', 'Affiliation': 'Department of Psychology, Illinois Institute of Technology, Chicago, IL, USA.'}, {'ForeName': 'Jason R', 'Initials': 'JR', 'LastName': 'Soble', 'Affiliation': 'Department of Psychiatry, University of Illinois College of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Young', 'Affiliation': 'Department of Psychology, Illinois Institute of Technology, Chicago, IL, USA.'}]",The Clinical neuropsychologist,['10.1080/13854046.2019.1631888']
699,30207486,The longevity of casein phosphopeptide-amorphous calcium phosphate fluoride varnish's preventative effects: Assessment of white spot lesion formation.,"OBJECTIVES


To test how long casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) fluoride varnish prevents enamel demineralization in vitro.
MATERIALS AND METHODS


Human molars and premolars were sectioned buccolingually and randomly assigned to two groups. Standardized pretreatment images of enamel surfaces were obtained using FluoreCam. The control group received no treatment, and the experimental group received an application of CPP-ACP fluoride varnish. Over simulated periods of 2, 4, 8, and 12 weeks, specimens were placed in a toothbrushing simulator, thermocycled, subjected to 9 days of pH cycling, and imaged with FluoreCam. Samples were sectioned and polished for polarized light microscope (PLM) evaluation.
RESULTS


There were statistically significant time ( P < .001) and varnish ( P < .001) effects on area, intensity, and impact of enamel demineralization. The control group showed significant and progressive demineralization over the 12 weeks ( P < .001). The experimental group revealed no significant demineralization during the first 4 weeks ( P > .05) and significant ( P < .001) increases thereafter. Experimental demineralization after 12 weeks was comparable to 2-week demineralization in the controls, with significant between-group differences ( P < .001) in enamel demineralization at all time points. PLM of the control and experimental groups revealed lesion depths of 90 ± 34 μm and 37 ± 9 μm, respectively.
CONCLUSIONS


Within the limitations of this in vitro study, CPP-ACP fluoride varnish prevents enamel demineralization for at least 4 weeks and limits demineralization up to 12 weeks.",2019,"PLM of the control and experimental groups revealed lesion depths of 90 ± 34 μm and 37 ± 9 μm, respectively.
","['Human molars and premolars', 'white spot lesion formation']","['CPP-ACP fluoride varnish', 'casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) fluoride varnish']","['area, intensity, and impact of enamel demineralization', 'progressive demineralization', 'Experimental demineralization', 'demineralization', 'enamel demineralization']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0026367', 'cui_str': 'Molar'}, {'cui': 'C1704302', 'cui_str': 'Premolar'}, {'cui': 'C0043154', 'cui_str': 'Dental White Spot'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}]","[{'cui': 'C1120338', 'cui_str': 'casein phosphopeptide-amorphous calcium phosphate nanocomplex'}, {'cui': 'C0016326', 'cui_str': 'Fluoride Varnishes'}, {'cui': 'C0007332', 'cui_str': 'Caseins'}, {'cui': 'C0031684', 'cui_str': 'Phosphopeptides'}, {'cui': 'C1956739', 'cui_str': 'Ca9(PO4)6'}]","[{'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0011350', 'cui_str': 'Enamel'}, {'cui': 'C0700185', 'cui_str': 'Demineralized structure'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}]",,0.0496609,"PLM of the control and experimental groups revealed lesion depths of 90 ± 34 μm and 37 ± 9 μm, respectively.
","[{'ForeName': 'Moufida', 'Initials': 'M', 'LastName': 'Abufarwa', 'Affiliation': ''}, {'ForeName': 'Amal', 'Initials': 'A', 'LastName': 'Noureldin', 'Affiliation': ''}, {'ForeName': 'Phillip M', 'Initials': 'PM', 'LastName': 'Campbell', 'Affiliation': ''}, {'ForeName': 'Peter H', 'Initials': 'PH', 'LastName': 'Buschang', 'Affiliation': ''}]",The Angle orthodontist,['10.2319/021718-127.1']
700,31787026,Home-based exercise with telemonitoring guidance in patients with coronary artery disease: Does it improve long-term physical fitness?,"BACKGROUND


Home-based interventions might facilitate the lifelong uptake of a physically active lifestyle following completion of a supervised phase II exercise-based cardiac rehabilitation. Yet, data on the long-term effectiveness of home-based exercise training on physical activity and exercise capacity are scarce.
OBJECTIVE


The purpose of the TeleRehabilitation in Coronary Heart disease (TRiCH) study was to compare the long-term effects of a short home-based phase III exercise programme with telemonitoring guidance to a prolonged centre-based phase III programme in coronary artery disease patients. The primary outcome was exercise capacity. Secondary outcomes included physical activity behaviour, cardiovascular risk profile and health-related quality of life.
METHODS


Ninety coronary artery disease patients (80 men) were randomly assigned to 3 months of home-based (30), centre-based (30) or a control group (30) on a 1:1:1 basis after completion of their phase II ambulatory cardiac rehabilitation programme. Outcome measures were assessed at discharge of the phase II programme and after one year.
RESULTS


Eighty patients (72 (91%) men; mean age 62.6 years) completed the one-year follow-up measurements. Exercise capacity and secondary outcomes were preserved in all three groups ( P time  > 0.05 for all), irrespective of the intervention ( P interaction  > 0.05 for all). Eighty-five per cent of patients met the international guidelines for physical activity ( P time  < 0.05). No interaction effect was found for physical activity.
CONCLUSION


Overall, exercise capacity remained stable during one year following phase II cardiac rehabilitation. Our home-based exercise intervention was as effective as centre-based and did not result in higher levels of exercise capacity and physical activity compared to the other two interventions.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02047942. https://clinicaltrials.gov/ct2/show/NCT02047942.",2020,"Our home-based exercise intervention was as effective as centre-based and did not result in higher levels of exercise capacity and physical activity compared to the other two interventions.
","['Ninety coronary artery disease patients (80 men', 'Eighty patients (72 (91%) men; mean age 62.6 years', 'patients with coronary artery disease', 'coronary artery disease patients']","['home-based exercise training', 'Home-based exercise with telemonitoring guidance', 'short home-based phase III exercise programme with telemonitoring guidance to a prolonged centre-based phase III programme']","['Exercise capacity and secondary outcomes', 'discharge of the phase II programme and after one year', 'physical activity behaviour, cardiovascular risk profile and health-related quality of life', 'physical activity', 'exercise capacity and physical activity', 'Overall, exercise capacity', 'exercise capacity']","[{'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",90.0,0.0568036,"Our home-based exercise intervention was as effective as centre-based and did not result in higher levels of exercise capacity and physical activity compared to the other two interventions.
","[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Avila', 'Affiliation': 'Department of Rehabilitation Science, KU Leuven, Belgium.'}, {'ForeName': 'Jomme', 'Initials': 'J', 'LastName': 'Claes', 'Affiliation': 'Department of Cardiovascular Sciences, KU Leuven, Belgium.'}, {'ForeName': 'Roselien', 'Initials': 'R', 'LastName': 'Buys', 'Affiliation': 'Department of Cardiovascular Sciences, KU Leuven, Belgium.'}, {'ForeName': 'May', 'Initials': 'M', 'LastName': 'Azzawi', 'Affiliation': 'Cardiovascular Research Group, Manchester Metropolitan University, UK.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Vanhees', 'Affiliation': 'Department of Rehabilitation Science, KU Leuven, Belgium.'}, {'ForeName': 'Veronique', 'Initials': 'V', 'LastName': 'Cornelissen', 'Affiliation': 'Department of Rehabilitation Science, KU Leuven, Belgium.'}]",European journal of preventive cardiology,['10.1177/2047487319892201']
701,31731006,A pilot multisite study of patient navigation for pregnant women with opioid use disorder.,"The opioid crisis continues to affect pregnant and postpartum women the United States, with the number of pregnant women diagnosed with opioid use disorder (OUD) quadrupling over the last decade. The associated increase in morbidity and mortality among mother and baby warrants prompt, targeted intervention efforts that improve engagement, linkage of care, and treatment retention. Patient navigation (PN) is a chronic care intervention that can directly address this need by helping women identify medical, behavioral, and psychosocial care goals. Moreover, PN can assist women in preparing for, engaging in, and maintaining patient participation in necessary services. Specifically, PN includes strengths-based case management, 1-1 clinical support, motivational interviewing, and addiction-relapse prevention programming. The objective of this article is to present the study protocol of a pilot multisite randomized clinical trial, entitled: Optimizing Pregnancy and Treatment Interventions for Moms 2.0 (OPTI-Mom 2.0; NCT03833245). In this study, we build upon a proof-of-concept study, employing evidence-informed frameworks for protocol and intervention expansion in order to construct a PN intervention tailored for pregnant women with OUD in central Utah and southwestern Pennsylvania. Our protocol provides an initial framework of a potentially impactful intervention and may guide development of future programs. Importantly, this study further establishes the evidence-base-with potential to ameliorate serious adverse opioid-related outcomes and improve health for women and their children.",2019,"The opioid crisis continues to affect pregnant and postpartum women the United States, with the number of pregnant women diagnosed with opioid use disorder (OUD) quadrupling over the last decade.","['pregnant women with OUD in central Utah and southwestern Pennsylvania', 'pregnant women with opioid use disorder']","['patient navigation', 'Patient navigation (PN']",['morbidity and mortality'],"[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0042124', 'cui_str': 'Utah'}, {'cui': 'C0030853', 'cui_str': 'Pennsylvania'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}]","[{'cui': 'C3494323', 'cui_str': 'Navigations, Patient'}]","[{'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",,0.0451756,"The opioid crisis continues to affect pregnant and postpartum women the United States, with the number of pregnant women diagnosed with opioid use disorder (OUD) quadrupling over the last decade.","[{'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'Cochran', 'Affiliation': 'Program for Addiction Research, Clinical Care, Knowledge and Advocacy (PARCKA), Division of Epidemiology, Department of Internal Medicine, University of Utah School of Medicine, Salt Lake City, UT, United States; Informatics, Decision-Enhancement, and Analytic Sciences Center, VA Salt Lake City Health Care System, Salt Lake City, UT, United States. Electronic address: jerry.cochran@hsc.utah.edu.'}, {'ForeName': 'Marcela C', 'Initials': 'MC', 'LastName': 'Smid', 'Affiliation': 'Department of Maternal Fetal Medicine, University of Utah School of Medicine, 30 N 1900 E, Salt Lake City, UT, United States.'}, {'ForeName': 'Elizabeth E', 'Initials': 'EE', 'LastName': 'Krans', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh School of Medicine, Magee-Womens Research Institute, 300 Halket Street, Pittsburgh, PA, United States.'}, {'ForeName': 'M Aryana', 'Initials': 'MA', 'LastName': 'Bryan', 'Affiliation': 'Program for Addiction Research, Clinical Care, Knowledge and Advocacy (PARCKA), Division of Epidemiology, Department of Internal Medicine, University of Utah School of Medicine, Salt Lake City, UT, United States; University of Utah College of Social Work, 395 S 1500 E #111, Salt Lake City, UT, United States.'}, {'ForeName': 'Adam J', 'Initials': 'AJ', 'LastName': 'Gordon', 'Affiliation': 'Program for Addiction Research, Clinical Care, Knowledge and Advocacy (PARCKA), Division of Epidemiology, Department of Internal Medicine, University of Utah School of Medicine, Salt Lake City, UT, United States; Informatics, Decision-Enhancement, and Analytic Sciences Center, VA Salt Lake City Health Care System, Salt Lake City, UT, United States.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Lundahl', 'Affiliation': 'University of Utah College of Social Work, 395 S 1500 E #111, Salt Lake City, UT, United States.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Silipigni', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh School of Medicine, Magee-Womens Research Institute, 300 Halket Street, Pittsburgh, PA, United States.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Haaland', 'Affiliation': 'Department of Population Health Sciences, University of Utah School of Medicine 30 N 1900 E, Salt Lake City, UT, United States.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Tarter', 'Affiliation': 'University of Pittsburgh School of Pharmacy, 3501 Terrace St, Pittsburgh, PA, United States.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105888']
702,31197364,Fluoride varnish for the prevention of white spot lesions during orthodontic treatment with fixed appliances: a randomized controlled trial.,"BACKGROUND


Self-applied and professional fluorides are key elements to limit caries-related side-effects during orthodontic treatment with fixed appliances.
OBJECTIVE


To evaluate the effectiveness of a new fluoride varnish formula containing 1.5% ammonium fluoride in preventing white spot lesions (WSLs) in adolescents undergoing multi-bracket orthodontic treatment.
SUBJECTS AND METHODS


The study employed a randomized controlled triple-blinded design with two parallel arms. One hundred eighty-two healthy adolescents (12-18 years) referred to three orthodontic specialist clinics were eligible and consecutively enrolled. Informed consent was obtained from 166 patients and they were randomly allocated to a test or a placebo group (with aid of a computer program, generating sequence numbers in blocks of 15). In the test group, fluoride varnish was applied in a thin layer around the bracket base every sixth week during the orthodontic treatment, while patients in the placebo group received a varnish without fluoride. The intervention started at onset of the fixed appliances and continued until debonding. The endpoint was prevalence and severity of WSLs on the labial surfaces of the maxillary incisors, canines, and premolars as scored from high-resolution pre- and post-treatment digital photos with aid of a four-level score.
RESULTS


One hundred forty-eight patients completed the trial, 75 in the test group and 73 in the placebo group (dropout rate 10.8%). The total prevalence of WSL's on subject level after debonding was 41.8% in the test group and 43.8% in the placebo group. The number of patients exhibiting more severe lesions (score 3 + 4) was higher in the placebo group (P < 0.05); the absolute risk reduction was 14% and the number needed to treat was 7.1.
LIMITATIONS


The multicentre design with somewhat diverging routines at the different clinics may have increased risk for performance bias. No health-economic evaluation was carried out.
CONCLUSIONS


Regular applications of an ammonium fluoride varnish reduced the prevalence of advanced WSL during treatment with fixed orthodontic appliances.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov (NCT03725020).
PROTOCOL


The protocol was not published before trial commencement.",2020,"The number of patients exhibiting more severe lesions (score 3 + 4) was higher in the placebo group (P < 0.05); the absolute risk reduction was 14% and the number needed to treat was 7.1.
","['166 patients', 'One hundred eighty-two healthy adolescents (12-18 years) referred to three orthodontic specialist clinics were eligible and consecutively enrolled', 'white spot lesions during orthodontic treatment with fixed appliances', 'adolescents undergoing multi-bracket orthodontic treatment', 'One hundred forty-eight patients completed the trial, 75 in the test group and 73 in the']","['placebo', 'fluoride varnish', 'varnish without fluoride', 'Fluoride varnish', 'new fluoride varnish formula containing 1.5% ammonium fluoride']","[""total prevalence of WSL's on subject level after debonding"", 'severe lesions', 'prevalence of advanced WSL', 'absolute risk reduction', 'prevalence and severity of WSLs on the labial surfaces of the maxillary incisors, canines, and premolars as scored from high-resolution pre- and post-treatment digital photos with aid of a four-level score', 'white spot lesions (WSLs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0686747', 'cui_str': 'Well adolescent (finding)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0029335', 'cui_str': 'Orthodontics'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0043154', 'cui_str': 'Dental White Spot'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0441421', 'cui_str': 'Permanent Retainer'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C4319608', 'cui_str': 'Forty-eight'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0016326', 'cui_str': 'Fluoride Varnishes'}, {'cui': 'C0042359', 'cui_str': 'Varnish'}, {'cui': 'C0016327', 'cui_str': 'Fluorides'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0051717', 'cui_str': 'ammonium fluoride'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C3179139', 'cui_str': 'Absolute Risk Reduction'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0023759', 'cui_str': 'Lip'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0021156', 'cui_str': 'Incisor'}, {'cui': 'C1704302', 'cui_str': 'Premolar'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0449435', 'cui_str': 'Aid (attribute)'}, {'cui': 'C0043154', 'cui_str': 'Dental White Spot'}]",182.0,0.527974,"The number of patients exhibiting more severe lesions (score 3 + 4) was higher in the placebo group (P < 0.05); the absolute risk reduction was 14% and the number needed to treat was 7.1.
","[{'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Sonesson', 'Affiliation': 'Department of Orthodontics, Faculty of Odontology, Malmö University.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Brechter', 'Affiliation': 'Bernhold Ortodonti, Private Practice, Helsingborg, Sweden.'}, {'ForeName': 'Salem', 'Initials': 'S', 'LastName': 'Abdulraheem', 'Affiliation': 'Department of Orthodontics, Faculty of Odontology, Malmö University.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Lindman', 'Affiliation': 'Ortodonti Syd, Private Practice, Hässleholm, Sweden.'}, {'ForeName': 'Svante', 'Initials': 'S', 'LastName': 'Twetman', 'Affiliation': 'Department of Odontology, Section for Cariology & Endodontics and Pediatric Dentistry & Clinical Genetics, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark.'}]",European journal of orthodontics,['10.1093/ejo/cjz045']
703,31105541,Influence of Combined Transcranial Direct Current Stimulation and Motor Training on Corticospinal Excitability in Children With Unilateral Cerebral Palsy.,"Combined non-invasive brain stimulation (NIBS) and rehabilitation interventions have the potential to improve function in children with unilateral cerebral palsy (UCP), however their effects on developing brain function are not well understood. In a proof-of-principle study, we used single-pulse transcranial magnetic stimulation (TMS) to measure changes in corticospinal excitability and relationships to motor performance following a randomized controlled trial consisting of 10 days of combined constraint-induced movement therapy (CIMT) and cathodal transcranial direct current stimulation (tDCS) applied to the contralesional motor cortex. Twenty children and young adults (mean age = 12 years, 9 months, range = 7 years, 7 months, 21 years, 7 months) with UCP participated. TMS testing was performed before, after, and 6 months after the intervention to measure motor evoked potential (MEP) amplitude and cortical silent period (CSP) duration. The association between neurophysiologic and motor outcomes and differences in excitability between hemispheres were examined. Contralesional MEP amplitude decreased as hypothesized in five of five participants receiving active tDCS immediately after and 6 months after the intervention, however no statistically significant differences between intervention groups were noted for MEP amplitude [mean difference = -323.9 μV, 95% CI = (-989, 341),  p  = 0.34] or CSP duration [mean difference = 3.9 ms, 95% CI = (-7.7, 15.5),  p  = 0.51]. Changes in corticospinal excitability were not statistically associated with improvements in hand function after the intervention. Across all participants, MEP amplitudes measured in the more-affected hand from both contralesional (mean difference = -474.5 μV) and ipsilesional hemispheres (-624.5 μV) were smaller compared to the less-affected hand. Assessing neurophysiologic changes after tDCS in children with UCP provides an understanding of long-term effects on brain excitability to help determine its potential as a therapeutic intervention. Additional investigation into the neurophysiologic effects of tDCS in larger samples of children with UCP are needed to confirm these findings.",2019,"Contralesional MEP amplitude decreased as hypothesized in five of five participants receiving active tDCS immediately after and 6 months after the intervention, however no statistically significant differences between intervention groups were noted for MEP amplitude [mean difference = -323.9 μV, 95% CI = (-989, 341),  p  = 0.34] or CSP duration [mean difference = 3.9 ms, 95% CI = (-7.7, 15.5),  p  = 0.51].","['Twenty children and young adults (mean age = 12 years, 9 months, range = 7 years, 7 months, 21 years, 7 months) with UCP participated', 'children with UCP', 'Children With Unilateral Cerebral Palsy', 'children with unilateral cerebral palsy (UCP']","['combined constraint-induced movement therapy (CIMT) and cathodal transcranial direct current stimulation (tDCS', 'Combined non-invasive brain stimulation (NIBS) and rehabilitation interventions', 'Combined Transcranial Direct Current Stimulation and Motor Training', 'pulse transcranial magnetic stimulation (TMS', 'tDCS']","['Contralesional MEP amplitude', 'corticospinal excitability', 'motor evoked potential (MEP) amplitude and cortical silent period (CSP) duration', 'MEP amplitude', 'MEP amplitudes', 'CSP duration', 'Corticospinal Excitability', 'μV) and ipsilesional hemispheres']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0007789', 'cui_str': 'CP (Cerebral Palsy)'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0454279', 'cui_str': 'Movement therapy (regime/therapy)'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive (qualifier value)'}, {'cui': 'C0870227', 'cui_str': 'Brain stimulation'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation (procedure)'}]","[{'cui': 'C0235169', 'cui_str': 'Excitability (finding)'}, {'cui': 'C0282617', 'cui_str': 'Evoked Potentials, Motor'}, {'cui': 'C0443304', 'cui_str': 'Silent (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1145610', 'cui_str': 'Cellulose sodium phosphate'}]",20.0,0.0566264,"Contralesional MEP amplitude decreased as hypothesized in five of five participants receiving active tDCS immediately after and 6 months after the intervention, however no statistically significant differences between intervention groups were noted for MEP amplitude [mean difference = -323.9 μV, 95% CI = (-989, 341),  p  = 0.34] or CSP duration [mean difference = 3.9 ms, 95% CI = (-7.7, 15.5),  p  = 0.51].","[{'ForeName': 'Samuel T', 'Initials': 'ST', 'LastName': 'Nemanich', 'Affiliation': 'Divisions of Physical Therapy and Rehabilitation Science, Department of Rehabilitation Medicine, University of Minnesota, Minneapolis, MN, United States.'}, {'ForeName': 'Tonya L', 'Initials': 'TL', 'LastName': 'Rich', 'Affiliation': 'Divisions of Physical Therapy and Rehabilitation Science, Department of Rehabilitation Medicine, University of Minnesota, Minneapolis, MN, United States.'}, {'ForeName': 'Chao-Ying', 'Initials': 'CY', 'LastName': 'Chen', 'Affiliation': 'Divisions of Physical Therapy and Rehabilitation Science, Department of Rehabilitation Medicine, University of Minnesota, Minneapolis, MN, United States.'}, {'ForeName': 'Jeremiah', 'Initials': 'J', 'LastName': 'Menk', 'Affiliation': 'Clinical and Translational Science Institute, Biostatistics, Design, and Analysis Center, University of Minnesota, Minneapolis, MN, United States.'}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Rudser', 'Affiliation': 'School of Public Health, Division of Biostatistics, University of Minnesota, Minneapolis, MN, United States.'}, {'ForeName': 'Mo', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'Non-invasive Neuromodulation Laboratory, University of Minnesota, Minneapolis, MN, United States.'}, {'ForeName': 'Gregg', 'Initials': 'G', 'LastName': 'Meekins', 'Affiliation': 'Department of Neurology, University of Minnesota, Minneapolis, MN, United States.'}, {'ForeName': 'Bernadette T', 'Initials': 'BT', 'LastName': 'Gillick', 'Affiliation': 'Divisions of Physical Therapy and Rehabilitation Science, Department of Rehabilitation Medicine, University of Minnesota, Minneapolis, MN, United States.'}]",Frontiers in human neuroscience,['10.3389/fnhum.2019.00137']
704,31764564,Comparison of Endoscope-Assisted Coblation Adenoidectomy to Conventional Curettage Adenoidectomy in Terms of Postoperative Eustachian Tube Function.,"INTRODUCTION


Adenoidectomy is one of the most common surgical procedures performed in children in otorhinolaryngology practice. This study aims to compare the conventional curettage adenoidectomy (CCA) and the endoscope-assisted coblation adenoidectomy (EACA) in terms of the postoperative Eustachian tube function and the surgical outcomes.
METHODS


A prospective, randomized, controlled study was carried out at a tertiary referral center and private hospital. Seventy-two adenoid hypertrophy patients without middle ear disease were randomly assigned to 2 groups to be operated via CCA and EACA techniques prior to surgery. Parameters including middle ear pressure values (MEPV), operative time, intraoperative hemorrhage, postoperative residual adenoid tissue, and postoperative pain were compared between groups.
RESULTS


In the CCA group for both ears, there was a statistically significant difference between preoperative mean MEPV and mean MEPV of postoperative day 1, while MEPV returned to normal ranges at the postoperative day 7. No statistically significant differences were observed in mean MEPV on preoperatively and 1st and 7th postoperative days in the EACA group for both right and left ears. Mean operative time was significantly higher in the EACA group compared to the CCA group (P < 0.001). Eight (22.2%) out of 36 patients who underwent CCA had a residual adenoid tissue postoperatively, while there was no residual adenoid tissue in any patients who operated via the EACA technique. Mean pain score on postoperative day 1 and 2 and blood loss were significantly less in the EACA group than the CCA group.
CONCLUSION


Endoscope-assisted coblation adenoidectomy may serve a reasonable alternative to conventional curettage adenoidectomy because it provides Eustachian tube functions preserved, decreased intraoperative hemorrhage, complete resection of the adenoid tissue, and lower pain score.",2020,No statistically significant differences were observed in mean MEPV on preoperatively and 1st and 7th postoperative days in the EACA group for both right and left ears.,"['tertiary referral center and private hospital', 'Seventy-two adenoid hypertrophy patients without middle ear disease']","['EACA', 'endoscope-assisted coblation adenoidectomy (EACA', 'CCA', 'Endoscope-Assisted Coblation Adenoidectomy to Conventional Curettage Adenoidectomy', 'conventional curettage adenoidectomy (CCA', 'Endoscope-assisted coblation adenoidectomy', 'CCA and EACA techniques prior to surgery']","['Mean pain score on postoperative day 1 and 2 and blood loss', 'preoperative mean MEPV and mean MEPV of postoperative day 1, while MEPV', 'Postoperative Eustachian Tube Function', 'Mean operative time', 'middle ear pressure values (MEPV), operative time, intraoperative hemorrhage, postoperative residual adenoid tissue, and postoperative pain', 'mean MEPV']","[{'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C0033173', 'cui_str': 'Hospitals, Private'}, {'cui': 'C4319632', 'cui_str': 'Seventy-two'}, {'cui': 'C0001428', 'cui_str': 'Pharyngeal Tonsils'}, {'cui': 'C0020564', 'cui_str': 'Hypertrophy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0013455', 'cui_str': 'Middle ear structure (body structure)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0014243', 'cui_str': 'Endoscopes'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0001425', 'cui_str': 'Adenoidectomy'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0010468', 'cui_str': 'Curettage'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0457584', 'cui_str': 'Eustachian tube function (observable entity)'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0457587', 'cui_str': 'Middle ear pressure (observable entity)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0079027', 'cui_str': 'Hemorrhage, Surgical'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0001428', 'cui_str': 'Pharyngeal Tonsils'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}]",,0.043658,No statistically significant differences were observed in mean MEPV on preoperatively and 1st and 7th postoperative days in the EACA group for both right and left ears.,"[{'ForeName': 'Secaattin', 'Initials': 'S', 'LastName': 'Gülşen', 'Affiliation': 'Department of Otorhinolaryngology, Dr Ersin Arslan Training And Research Hospital.'}, {'ForeName': 'Sercan', 'Initials': 'S', 'LastName': 'Çikrikçi', 'Affiliation': 'Department of Otorhinolaryngology, Yozgat State Hospital, Yozgat, Turkey.'}]",The Journal of craniofacial surgery,['10.1097/SCS.0000000000006039']
705,31760487,Early mobilization versus plaster immobilization of simple elbow dislocations: a cost analysis of the FuncSiE multicenter randomized clinical trial.,"INTRODUCTION


The primary aim was to assess and compare the total costs (direct health care costs and indirect costs due to loss of production) after early mobilization versus plaster immobilization in patients with a simple elbow dislocation. It was hypothesized that early mobilization would not lead to higher direct and indirect costs.
MATERIALS AND METHODS


This study used data of a multicenter randomized clinical trial (FuncSiE trial). From August 25, 2009 until September 18, 2012, 100 adult patients with a simple elbow dislocation were recruited and randomized to early mobilization (immediate motion exercises; n = 48) or 3 weeks plaster immobilization (n = 52). Patients completed questionnaires on health-related quality of life [EuroQoL-5D (EQ-5D) and Short Form-36 (SF-36 PCS and SF-36 MCS)], health care use, and work absence. Follow-up was 1 year. Primary outcome were the total costs at 1 year. Analysis was by intention to treat.
RESULTS


There were no significant differences in EQ-5D, SF-36 PCS, and SF-36 MCS between the two groups. Mean total costs per patient were €3624 in the early mobilization group versus €7072 in the plaster group (p = 0.094). Shorter work absenteeism in the early mobilization group (10 versus 18 days; p = 0.027) did not lead to significantly lower costs for loss of productivity (€1719 in the early mobilization group versus €4589; p = 0.120).
CONCLUSION


From a clinical and a socio-economic point of view, early mobilization should be the treatment of choice for a simple elbow dislocation. Plaster immobilization has inferior results at almost double the cost.",2020,Mean total costs per patient were €3624 in the early mobilization group versus €7072 in the plaster group (p = 0.094).,"['patients with a simple elbow dislocation', 'From August 25, 2009 until September 18, 2012, 100 adult patients with a simple elbow dislocation']","['early mobilization (immediate motion exercises; n\u2009=\u200948) or 3\xa0weeks plaster immobilization', 'Early mobilization versus plaster immobilization of simple elbow dislocations', 'early mobilization versus plaster immobilization']","['total costs at 1\xa0year', 'health-related quality of life [EuroQoL-5D (EQ-5D) and Short Form-36 (SF-36 PCS and SF-36 MCS)], health care use, and work absence', 'Mean total costs', 'total costs (direct health care costs and indirect costs', 'EQ-5D, SF-36 PCS, and SF-36 MCS', 'loss of productivity', 'Shorter work absenteeism']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C2720437', 'cui_str': 'Dislocation of elbow joint (disorder)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0013459', 'cui_str': 'Early Mobilization'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0687704', 'cui_str': 'Motions (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0460977', 'cui_str': 'Plasters (physical object)'}, {'cui': 'C0020944', 'cui_str': 'Immobilization'}, {'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C2720437', 'cui_str': 'Dislocation of elbow joint (disorder)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C1689985', 'cui_str': 'Absence'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}, {'cui': 'C0439852', 'cui_str': 'Indirect (qualifier value)'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0000849', 'cui_str': 'Absenteeism'}]",100.0,0.199933,Mean total costs per patient were €3624 in the early mobilization group versus €7072 in the plaster group (p = 0.094).,"[{'ForeName': 'Esther M M', 'Initials': 'EMM', 'LastName': 'Van Lieshout', 'Affiliation': 'Trauma Research Unit, Department of Surgery, Erasmus MC, University Medical Center Rotterdam, P.O. Box 2040, 3000 CA, Rotterdam, The Netherlands.'}, {'ForeName': 'Gijs I T', 'Initials': 'GIT', 'LastName': 'Iordens', 'Affiliation': 'Trauma Research Unit, Department of Surgery, Erasmus MC, University Medical Center Rotterdam, P.O. Box 2040, 3000 CA, Rotterdam, The Netherlands.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Polinder', 'Affiliation': 'Department of Public Health, Erasmus MC, University Medical Center Rotterdam, P.O. Box 2040, 3000 CA, Rotterdam, The Netherlands.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Eygendaal', 'Affiliation': 'Upper Limb Unit, Department of Orthopaedic Surgery, Amphia Hospital, P.O. Box 90158, 4800 RK, Breda, The Netherlands.'}, {'ForeName': 'Michael H J', 'Initials': 'MHJ', 'LastName': 'Verhofstad', 'Affiliation': 'Trauma Research Unit, Department of Surgery, Erasmus MC, University Medical Center Rotterdam, P.O. Box 2040, 3000 CA, Rotterdam, The Netherlands.'}, {'ForeName': 'Niels W L', 'Initials': 'NWL', 'LastName': 'Schep', 'Affiliation': 'Trauma Unit, Department of Surgery, Academic Medical Center, P.O. Box 22660, 1100 DD, Amsterdam, The Netherlands.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Den Hartog', 'Affiliation': 'Trauma Research Unit, Department of Surgery, Erasmus MC, University Medical Center Rotterdam, P.O. Box 2040, 3000 CA, Rotterdam, The Netherlands. d.denhartog@erasmusmc.nl.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Archives of orthopaedic and trauma surgery,['10.1007/s00402-019-03309-1']
706,31470260,"A randomized, 6-wk trial of a low FODMAP diet in patients with inflammatory bowel disease.","OBJECTIVE


The aim of this study was to assess the safety and efficacy of a low fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAP) diet (LFD) in patients with inflammatory bowel disease (IBD).
METHODS


An LFD is associated with symptom improvement in patients with functional intestinal disorders, although its safety and efficacy has not been characterized in patients with IBD. Fifty-five patients with IBD in remission or with mild disease activity were randomized to a 6-wk LFD or standard diet (SD). Disease activity (Harvey-Bradshaw index [HBi], partial Mayo score), fecal calprotectin, and disease-specific quality of life (IBD-Q) were assessed at baseline and at the end of dietary intervention.
RESULTS


After the 6-wk dietary intervention, median HBi decreased in the LFD (4; IQR, 3-5 versus 3; IQR, 2-3; P = 0.024) but not in the SD (3; IQR, 3-3 versus 3; IQR, 2-4), whereas Mayo scores were numerically decreased in the LFD group and unmodified in the SD group. Median calprotectin decreased in the LFD (76.6 mg/kg; IQR, 50-286.3 versus 50 mg/kg; IQR, 50.6-81; P = 0.004) but not in the SD group (91 mg/kg; IQR, 50.6-143.6 versus 87 mg/kg; IQR, 50-235.6). Lastly, we observed a barely significant increase in median IBD-Q in the LFD group (166; IQR, 139-182 versus 177; IQR, 155-188; P = 0.05) and no modification in the SD group (181; IQR, 153-197 versus 166; IQR, 153-200).
CONCLUSIONS


A short-term, LFD is safe for patients with IBD, and is associated with an amelioration of fecal inflammatory markers and quality of life even in patients with mainly quiescent disease.",2019,"Median calprotectin decreased in the LFD (76.6 mg/kg; IQR, 50-286.3 versus 50 mg/kg; IQR, 50.6-81; P = 0.004) but not in the SD group (91 mg/kg; IQR, 50.6-143.6 versus 87 mg/kg; IQR, 50-235.6).","['patients with functional intestinal disorders', 'patients with mainly quiescent disease', 'patients with IBD', 'Fifty-five patients with IBD in remission or with mild disease activity', 'patients with inflammatory bowel disease', 'patients with inflammatory bowel disease (IBD']","['LFD', '6-wk LFD or standard diet (SD', 'low FODMAP diet', 'low fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAP) diet (LFD']","['Disease activity (Harvey-Bradshaw index [HBi], partial Mayo score), fecal calprotectin, and disease-specific quality of life (IBD-Q', 'Mayo scores', 'Median calprotectin', 'median HBi', 'median IBD-Q', 'safety and efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory Bowel Diseases'}, {'cui': 'C0450382', 'cui_str': '55 (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C4552346', 'cui_str': 'FODMAP diet'}, {'cui': 'C0028959', 'cui_str': 'Oligosaccharides'}, {'cui': 'C0012611', 'cui_str': 'Disaccharides'}, {'cui': 'C0026492', 'cui_str': 'Simple Sugars'}, {'cui': 'C0071629', 'cui_str': 'polyol'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0454788', 'cui_str': 'Mayo (geographic location)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1964053', 'cui_str': 'Faecal calprotectin'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0034380'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory Bowel Diseases'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0950624', 'cui_str': 'Calgranulin'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",55.0,0.0881385,"Median calprotectin decreased in the LFD (76.6 mg/kg; IQR, 50-286.3 versus 50 mg/kg; IQR, 50.6-81; P = 0.004) but not in the SD group (91 mg/kg; IQR, 50.6-143.6 versus 87 mg/kg; IQR, 50-235.6).","[{'ForeName': 'Giorgia', 'Initials': 'G', 'LastName': 'Bodini', 'Affiliation': ""Gastroenterology Unit, Department of Internal Medicine, University of Genoa, Ospedale Policlinico San Martino-IRCCS per l'Oncologia, Genoa, Italy. Electronic address: giorgia.bodini@unige.it.""}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Zanella', 'Affiliation': ""Gastroenterology Unit, Department of Internal Medicine, University of Genoa, Ospedale Policlinico San Martino-IRCCS per l'Oncologia, Genoa, Italy.""}, {'ForeName': 'Mattia', 'Initials': 'M', 'LastName': 'Crespi', 'Affiliation': ""Gastroenterology Unit, Department of Internal Medicine, University of Genoa, Ospedale Policlinico San Martino-IRCCS per l'Oncologia, Genoa, Italy.""}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Lo Pumo', 'Affiliation': ""Gastroenterology Unit, Department of Internal Medicine, University of Genoa, Ospedale Policlinico San Martino-IRCCS per l'Oncologia, Genoa, Italy.""}, {'ForeName': 'Maria Giulia', 'Initials': 'MG', 'LastName': 'Demarzo', 'Affiliation': ""Gastroenterology Unit, Department of Internal Medicine, University of Genoa, Ospedale Policlinico San Martino-IRCCS per l'Oncologia, Genoa, Italy.""}, {'ForeName': 'Edoardo', 'Initials': 'E', 'LastName': 'Savarino', 'Affiliation': ""Gastroenterology Unit, Department of Internal Medicine, University of Genoa, Ospedale Policlinico San Martino-IRCCS per l'Oncologia, Genoa, Italy.""}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Savarino', 'Affiliation': ""Gastroenterology Unit, Department of Internal Medicine, University of Genoa, Ospedale Policlinico San Martino-IRCCS per l'Oncologia, Genoa, Italy.""}, {'ForeName': 'Edoardo G', 'Initials': 'EG', 'LastName': 'Giannini', 'Affiliation': ""Gastroenterology Unit, Department of Internal Medicine, University of Genoa, Ospedale Policlinico San Martino-IRCCS per l'Oncologia, Genoa, Italy.""}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2019.06.023']
707,31765030,"Effectiveness of nCPAP for moderate preterm infants compared to BiPAP: A Randomized, Controlled Non-Inferiority Trial.","BACKGROUND


Bilevel positive airway pressure (BiPAP) has recently been used in preterm infants with respiratory distress as an alternative to nasal continuous positive airway pressure (nCPAP) because, theoretically, BiPAP is thought to be more effective than nCPAP. However, the results of some studies comparing nCPAP with BiPAP as the initial respiratory support were controversial. The aim of this study is to compare the clinical effectiveness and safety of nCPAP with BiPAP at gestational ages of 30 +0  to 34 +6   weeks.
METHODS


A total of 93 infants with gestational ages of 30 +0  to 34 +6   weeks, who presented with respiratory distress within 24 h after birth, were randomized to the nCPAP group or the BiPAP group. The primary outcome was the incidence of treatment failure with these two non-invasive respiratory support devices. Criteria for treatment failure included any of the following: respiratory acidosis (PaCO 2  >65 mmHg with pH <7.2), hypoxia (FiO2 >0.4), or apnea (>2-3 episodes of apnea/h).
RESULTS


There was no statistically significant difference in treatment failure between the two groups (P = 0.576). The risk difference comparing treatment failure rate between nCPAP and BiPAP groups was -4.7% (95% CI: -21.5-11.9).
CONCLUSIONS


Nasal continuous positive airway pressure is not inferior to BiPAP as an initial management of respiratory distress in these premature infants. We therefore conclude that nCPAP can be used as an initial management for preterm infants at gestational age of between 30 and 35 weeks as a substitute for BiPAP.",2020,There was no statistically significant difference in treatment failure between the two groups (p = 0.576).,"['preterm infants at gestational age of between 30 and 35 weeks as a substitute for BiPAP', 'A total 93 infants with gestational age of 30 +0  to 34 +6  weeks who presented respiratory distress within 24 hours after birth', 'premature infants', 'preterm infants with respiratory distress', 'moderate preterm infants', 'PaCO 2  > 65 mmHg with pH < 7.2), hypoxia (FiO2 > 0.4), or apnea (>2-3 episodes of apnea/hour']","['BiPAP ', 'BiPAP', 'nCPAP', 'Bi-level positive airway pressure (BiPAP', 'nCPAP with BiPAP']","['treatment failure', 'incidence of treatment failure with these two non-invasive respiratory support devices', 'failure rate', 'respiratory acidosis']","[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1611149', 'cui_str': 'Bilevel positive airway pressure'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0476273', 'cui_str': 'Respiratory distress (finding)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C4517857', 'cui_str': '7.2 (qualifier value)'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0428167', 'cui_str': 'FIO2'}, {'cui': 'C4517457', 'cui_str': 'Zero point four'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}]","[{'cui': 'C1611149', 'cui_str': 'Bilevel positive airway pressure'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}]","[{'cui': 'C0162643'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0001127', 'cui_str': 'Acidosis, Respiratory'}]",93.0,0.134021,There was no statistically significant difference in treatment failure between the two groups (p = 0.576).,"[{'ForeName': 'Mi-Ji', 'Initials': 'MJ', 'LastName': 'Lee', 'Affiliation': 'Department of Pediatrics, Korea University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Eui Kyung', 'Initials': 'EK', 'LastName': 'Choi', 'Affiliation': 'Department of Pediatrics, Korea University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Kyu Hee', 'Initials': 'KH', 'LastName': 'Park', 'Affiliation': 'Department of Pediatrics, Korea University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Jeonghee', 'Initials': 'J', 'LastName': 'Shin', 'Affiliation': 'Department of Pediatrics, Korea University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Byung Min', 'Initials': 'BM', 'LastName': 'Choi', 'Affiliation': 'Department of Pediatrics, Korea University College of Medicine, Seoul, Korea.'}]",Pediatrics international : official journal of the Japan Pediatric Society,['10.1111/ped.14061']
708,32410596,Interpretation of within-group change in randomised trials.,"In medicine, it is common to observe improvement after intervention, at least partly because patients present for care in extremis and would have improved without intervention. Controlling for this counterfactual explanation for improvement is the principle reason to conduct a trial in which patients are randomised to treatment or a control group. Accordingly, it is not reasonable to infer that both interventions are effective when the groups show similar improvements in outcome.",2020,"Accordingly, it is not reasonable to infer that both interventions are effective when the groups show similar improvements in outcome.",[],[],[],[],[],[],,0.069099,"Accordingly, it is not reasonable to infer that both interventions are effective when the groups show similar improvements in outcome.","[{'ForeName': 'Kypros', 'Initials': 'K', 'LastName': 'Kypri', 'Affiliation': 'Centre for Clinical Epidemiology and Biostatistics, School of Medicine and Public Health, University of Newcastle, Callaghan, New South Wales, Australia. kypros.kypri@newcastle.edu.au.'}]",BMC psychiatry,['10.1186/s12888-020-02641-w']
709,31563743,Barriers to and facilitators for adherence to nutritional intervention: Consumption of fruits and vegetables.,"OBJECTIVES


The aim of this study was to investigate the barriers and facilitators for the adherence of participants to a nutritional intervention.
METHODS


A randomized controlled trial was carried out with participants from the Health Academy Program in Belo Horizonte, MG, Brazil. The intervention (7 mo) was based on the Transtheoretical Model and on Paulo Freire's pedagogy and offered 12 education activities with the purpose of promoting the consumption of fruits and vegetables. Adherene was determined by calculating the participation percentage (attendance at activities/number of activities).
RESULTS


In all, 1483 individuals participated and the average adherence was 58.3%. Low adherence was demonstrated by 24.3%, medium adherence by 26.5%, and high adherence by 49.2% of the participants. Adherence was associated with aging (odds ratio [OR], 1.97; 95% CI, 1.33-2.94), being unemployed (OR, 0.75; 95% CI, 0.58-0.95), not being under psychiatric treatment (OR, 0.77; 95% CI, 0.63-0.95), participant body satisfaction (OR, 1.27; 95% CI, 1.02-1.58) and participant attendance at the Health Academy Program for >1 y (OR, 2.78; 95% CI, 2.17-3.56). The qualitative analysis revealed the following facilitators for adherence: service structure, intervention methodology, bond-building among users and professionals, family support, and patient-associated aspects. The barriers to adherence included work, self-care, and care for another.
CONCLUSION


Adherence to the intervention was high, and the patient-associated aspects, the logistics of the Health Academy Program, and the methodology appeared to contribute to adherence. However, the timetable was a barrier for those who were working and for those who support their families.",2019,"Adherence was associated with aging (odds ratio [OR], 1.97; 95% CI, 1.33-2.94), being unemployed (OR, 0.75; 95% CI, 0.58-0.95), not being under psychiatric treatment (OR, 0.77; 95% CI, 0.63-0.95), participant body satisfaction (OR, 1.27; 95% CI, 1.02-1.58) and participant attendance at the Health Academy Program for >1 y (OR, 2.78; 95% CI, 2.17-3.56).","['1483 individuals participated and the average adherence was 58.3', 'participants to a nutritional intervention', 'participants from the Health Academy Program in Belo Horizonte, MG, Brazil']",[],"['Low adherence', 'Adherence', 'participant body satisfaction']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0000876', 'cui_str': 'Academies'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}]",[],"[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",1483.0,0.0376567,"Adherence was associated with aging (odds ratio [OR], 1.97; 95% CI, 1.33-2.94), being unemployed (OR, 0.75; 95% CI, 0.58-0.95), not being under psychiatric treatment (OR, 0.77; 95% CI, 0.63-0.95), participant body satisfaction (OR, 1.27; 95% CI, 1.02-1.58) and participant attendance at the Health Academy Program for >1 y (OR, 2.78; 95% CI, 2.17-3.56).","[{'ForeName': 'Raquel de Deus', 'Initials': 'RD', 'LastName': 'Mendonça', 'Affiliation': 'Nutrition Department, Federal University of Minas Gerais, Belo Horizonte, Brazil.'}, {'ForeName': 'Larissa Morelli Ferraz', 'Initials': 'LMF', 'LastName': 'Guimarães', 'Affiliation': 'Nutrition Department, Federal University of Minas Gerais, Belo Horizonte, Brazil.'}, {'ForeName': 'Suely Aparecida', 'Initials': 'SA', 'LastName': 'Mingoti', 'Affiliation': 'Institute of Exact Sciences, Federal University of Minas Gerais, Belo Horizonte, Brazil.'}, {'ForeName': 'Kelly Alves', 'Initials': 'KA', 'LastName': 'Magalhães', 'Affiliation': 'Núcleo de Apoio a Saúde da Família, Secretaria Municipal de Saúde de Belo Horizonte, Research Group on Nutrition Interventions, Belo Horizonte, Brazil.'}, {'ForeName': 'Aline Cristine Souza', 'Initials': 'ACS', 'LastName': 'Lopes', 'Affiliation': 'Nutrition Department, Federal University of Minas Gerais, Belo Horizonte, Brazil. Electronic address: Alinelopesenf@gmail.com.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2019.110568']
710,31165457,Effects of neuromuscular block reversal with sugammadex versus neostigmine on postoperative respiratory outcomes after major abdominal surgery: a randomized-controlled trial.,"PURPOSE


Postoperative pulmonary complications may be better reduced by reversal of neuromuscular block with sugammadex than by reversal with neostigmine because the incidence of residual block after sugammadex application is lower and diaphragm function is less impaired than after neostigmine administration. The aim of the study was to compare the effect of reversal of neuromuscular block with sugammadex or neostigmine on lung function after major abdominal surgery.
METHODS


One hundred and thirty adults scheduled for major abdominal surgery under combined general and epidural anesthesia were randomly allocated to receive 40 µg of neostigmine or 4 mg·kg -1  of sugammadex to reverse neuromuscular block. Two blinded researchers performed spirometry and lung ultrasound before the surgery, as well as 1 hr and 24 hr postoperatively. Differences in mean changes from baseline were analyzed with repeated measures analysis of variance. Forced vital capacity (FVC) loss one hour after surgery was the main outcome. Secondary outcomes were differences in rate and size of atelectasis one hour and 24 hr after surgery.
RESULTS


One hundred twenty-six patients were included in the main analysis. In the neostigmine group (n = 64), mean (95% confidence interval [95% CI]) reduction in FVC after one hour was 0.5 (0.4 to 0.6) L. In the sugammadex group (n = 62), the mean (95% CI) reduction in FVC during the first hour was 0.5 (95% CI, 0.3 to 0.6) L. Thirty-nine percent of patients in the neostigmine group and 29% in the sugammadex group had visible atelectasis. Median [interquartile range (IQR)] atelectasis area was 9.7 [4.7-13.1] cm 2  and 6.8 [3.6-12.5] cm 2 , respectively.
CONCLUSION


We found no differences in pulmonary function in patients reversed with sugammadex or neostigmine in a high-risk population.
TRIAL REGISTRATION


EudraCT 2014-005156-26; registered 27 May, 2015.",2019,"In the sugammadex group (n = 62), the mean (95% CI) reduction in FVC during the first hour was 0.5 (95% CI, 0.3 to 0.6)","['One hundred and thirty adults scheduled for major abdominal surgery under combined general and epidural anesthesia', 'major abdominal surgery', 'One hundred twenty-six patients were included in the main analysis']","['sugammadex versus neostigmine', 'EudraCT', 'sugammadex or neostigmine', 'neostigmine', 'neostigmine or 4 mg·kg -1  of sugammadex to reverse neuromuscular block']","['FVC', 'pulmonary function', 'rate and size of atelectasis one hour and 24 hr after surgery', 'atelectasis area', 'Forced vital capacity (FVC) loss', 'visible atelectasis', 'Median [interquartile range (IQR', 'lung function', 'postoperative respiratory outcomes']","[{'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0002913', 'cui_str': 'Anesthesia, Extradural'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0450349', 'cui_str': '26 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C1700695', 'cui_str': 'Sugammadex'}, {'cui': 'C0027679', 'cui_str': 'Neostigmine'}, {'cui': 'C0235062', 'cui_str': 'Neuromuscular Block'}]","[{'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0004144', 'cui_str': 'Lung Collapse'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C3714541', 'cui_str': 'Forced Vital Capacity'}, {'cui': 'C0205379', 'cui_str': 'Visible (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}]",126.0,0.451806,"In the sugammadex group (n = 62), the mean (95% CI) reduction in FVC during the first hour was 0.5 (95% CI, 0.3 to 0.6)","[{'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Alday', 'Affiliation': 'Hospital Universitario La Princesa, C/Diego de León 62, 28006, Madrid, Spain. kikealday@hotmail.com.'}, {'ForeName': 'Manolo', 'Initials': 'M', 'LastName': 'Muñoz', 'Affiliation': 'Hospital Universitario La Princesa, C/Diego de León 62, 28006, Madrid, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Planas', 'Affiliation': 'Hospital Universitario La Princesa, C/Diego de León 62, 28006, Madrid, Spain.'}, {'ForeName': 'Esperanza', 'Initials': 'E', 'LastName': 'Mata', 'Affiliation': 'Hospital Universitario La Princesa, C/Diego de León 62, 28006, Madrid, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Alvarez', 'Affiliation': 'Hospital Universitario La Princesa, C/Diego de León 62, 28006, Madrid, Spain.'}]",Canadian journal of anaesthesia = Journal canadien d'anesthesie,['10.1007/s12630-019-01419-3']
711,31669450,Rationale and design of a randomized pragmatic trial of patient-centered models of hepatitis C treatment for people who inject drugs: The HERO study.,"BACKGROUND


Although people who inject drugs (PWID) having the highest incidence and prevalence of hepatitis C virus (HCV) in the US, HCV treatment is rarely provided to PWID due to assumptions about poor adherence and reinfection risk. As direct-acting antiviral agents (DAAs) have achieved sustained virologic response (SVR) rates of 95% or more, evidence-based strategies are urgently needed to demonstrate real-world effectiveness in marginalized patient populations such as PWID. The objectives of this study are: 1) to determine whether either of two patient-centered treatment models - patient navigation (PN) or modified directly observed therapy (mDOT) - results in more forward movement along the HCV care cascade including treatment initiation, adherence, and SVR; 2) using quantitative and qualitative methods, to understand factors associated with lack of treatment uptake, poor adherence (<80%), failure to achieve SVR, DAA resistance, and HCV reinfection.
METHODS


The HERO study is a multi-site, pragmatic randomized clinical trial conducted in eight states where 754 HCV-infected PWID were randomly assigned to either PN or mDOT.
CONCLUSIONS


This study addresses an urgent need for timely and accurate information on optimal models of care to promote HCV treatment initiation, adherence, treatment completion and SVR among PWID, as well as rates and factors associated with reinfection and resistance after treatment. This clinical trial has the potential to provide valuable information on how to reduce the burden of the HCV epidemic in PWID.",2019,"Although people who inject drugs (PWID) having the highest incidence and prevalence of hepatitis C virus (HCV) in the US, HCV treatment is rarely provided to PWID due to assumptions about poor adherence and reinfection risk.","['eight states where 754 HCV-infected PWID', 'people who inject drugs']","['direct-acting antiviral agents (DAAs', 'hepatitis C treatment', 'two patient-centered treatment models - patient navigation (PN) or modified directly observed therapy (mDOT) ', 'PN or mDOT']","['failure to achieve SVR, DAA resistance, and HCV reinfection', 'virologic response (SVR) rates']","[{'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C4521936', 'cui_str': 'Inject (administration method)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}]","[{'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0003451', 'cui_str': 'Antiviral Drugs'}, {'cui': 'C0019196', 'cui_str': 'Parenterally-Transmitted Non-A, Non-B Hepatitis'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C3494323', 'cui_str': 'Navigations, Patient'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0872145', 'cui_str': 'Directly Observed Therapy'}]","[{'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0205339', 'cui_str': 'Reinfection (qualifier value)'}, {'cui': 'C0205466', 'cui_str': 'virology'}]",,0.0854155,"Although people who inject drugs (PWID) having the highest incidence and prevalence of hepatitis C virus (HCV) in the US, HCV treatment is rarely provided to PWID due to assumptions about poor adherence and reinfection risk.","[{'ForeName': 'Alain H', 'Initials': 'AH', 'LastName': 'Litwin', 'Affiliation': 'Clemson University School of Health Research, Clemson, SC, USA; Department of Medicine, University of South Carolina School of Medicine, Greenville, SC, USA; Department of Medicine, Prisma Health, Greenville, SC, USA. Electronic address: Alain.Litwin@prismahealth.org.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Jost', 'Affiliation': 'Department of Medicine, Montefiore Medical Center, Bronx, NY, USA.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Wagner', 'Affiliation': 'Department of Internal Medicine, University of New Mexico Health Sciences Center, Albuquerque, NM, USA.'}, {'ForeName': 'Moonseong', 'Initials': 'M', 'LastName': 'Heo', 'Affiliation': 'Department of Public Health Sciences, College of Behavioral, Social, and Health Sciences, Clemson University Clemson, SC, USA.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Karasz', 'Affiliation': 'Einstein College of Medicine, Bronx, NY, USA.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Feinberg', 'Affiliation': 'Department of Behavioral Medicine & Psychiatry and Department of Medicine, West Virginia University, Morgantown, WV, USA.'}, {'ForeName': 'Arthur Y', 'Initials': 'AY', 'LastName': 'Kim', 'Affiliation': 'Department of Infectious Diseases, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Paula J', 'Initials': 'PJ', 'LastName': 'Lum', 'Affiliation': 'Department of Medicine, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Shruti H', 'Initials': 'SH', 'LastName': 'Mehta', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Lynn E', 'Initials': 'LE', 'LastName': 'Taylor', 'Affiliation': 'College of Pharmacy, University of Rhode Island, CODAC Behavioral Health, Providence, RI, USA.'}, {'ForeName': 'Judith I', 'Initials': 'JI', 'LastName': 'Tsui', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Pericot-Valverde', 'Affiliation': 'Clemson University School of Health Research, Clemson, SC, USA; Department of Medicine, Prisma Health, Greenville, SC, USA.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Page', 'Affiliation': 'Department of Internal Medicine, University of New Mexico Health Sciences Center, Albuquerque, NM, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Contemporary clinical trials,['10.1016/j.cct.2019.105859']
712,31154664,Maternal Serum Lipid Trajectories and Association with Pregnancy Loss and Length of Gestation.,"OBJECTIVE


We characterized lipid trajectories and investigated lipids and rate of pregnancy lipid change with the risk of pregnancy loss or preterm delivery <37 weeks.
STUDY DESIGN


In a secondary analysis of 337 women with one to two prior losses assigned to placebo in a randomized controlled trial at four centers (2007-2012), cholesterol, low- and high-density lipoprotein cholesterol (HDL-C), and triglycerides were measured up to 6 months prepregnancy (time 0) and pregnancy up to 7 visits. Trajectories were created using linear mixed models. Multivariable logistic regression with adjustment for maternal characteristics and cholesterol was performed.
RESULTS


Lipids decreased from prepregnancy to 4 to 5 weeks, followed by an increase, and were biphasic or triphasic depending on the lipid component. Between 4 and 8 weeks, for every 1-unit increase in HDL-C, there was a 22% decreased odds of loss <14 weeks (odds ratio: 0.78; 95% confidence interval: 0.60, 0.99) and 24% decreased odds of loss or preterm delivery 14 to <37 weeks (odds ratio: 0.76; 95% confidence interval: 0.60, 0.96).
CONCLUSION


There were no associations with other lipid components or other time points. An impaired rise of HDL-C early in pregnancy may signal maladaptation to pregnancy that is associated with pregnancy loss or preterm delivery.",2020,There were no associations with other lipid components or other time points.,['337 women with one to two prior losses assigned to'],['placebo'],"['HDL-C', 'Maternal Serum Lipid Trajectories and Association with Pregnancy Loss and Length of Gestation', 'cholesterol, low- and high-density lipoprotein cholesterol (HDL-C), and triglycerides']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0687675', 'cui_str': 'Pregnancy loss'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0023822', 'cui_str': 'High Density Lipoprotein Cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}]",337.0,0.217667,There were no associations with other lipid components or other time points.,"[{'ForeName': 'Katherine L', 'Initials': 'KL', 'LastName': 'Grantz', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Elmi', 'Affiliation': 'Biostatistics and Bioinformatics Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Pugh', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Catov', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Science and Department of Epidemiology, Magee-Womens Research Institute, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Lindsey', 'Initials': 'L', 'LastName': 'Sjaarda', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'Albert', 'Affiliation': 'Biostatistics and Bioinformatics Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland.'}]",American journal of perinatology,['10.1055/s-0039-1689000']
713,31754238,Exercise effects on arterial stiffness and heart health in children with excess weight: The SMART RCT.,"INTRODUCTION


Childhood obesity and inactivity are associated with cardiovascular risk. Evidence is limited for exercise effects on arterial health in children.
METHODS


One hundred and seventy-five inactive children with overweight or obesity (8-11 years, ≥85th percentile BMI, 61% female, 87% Black, 73% with obesity) were randomized to an 8-month daily after-school aerobic exercise program (40 min/day, n = 90) or a sedentary control condition (n = 85). Carotid-femoral pulse wave velocity (PWV, primary outcome, arterial stiffness), fitness, adiposity, blood pressure (BP), glucose, insulin resistance, lipids, and C-reactive protein were measured at baseline and posttest (8 months). Adiposity, fitness, and BP were measured again at follow-up, 8-12 months later. Intent-to-treat analyses were conducted using mixed models.
RESULTS


The study had 89% retention, with attendance of 59% in exercise and 64% in the control condition, and vigorous exercise participation (average heart rate 161 ± 7 beats/min). Compared with controls, the exercise group had twice the improvement in fitness (VȮ 2  peak, 2.7 (95% CI 1.8, 3.6) vs. 1.3 (0.4, 2.3) mL/kg/min) and adiposity (-1.8 (-2.4, -1.1) vs. -0.8 (-1.5, -0.1)%), each p = 0.04, and a large improvement in HDL-cholesterol (0.13 (0.075, 0.186) vs. -0.028 (-0.083, 0.023) mmol/L, p < 0.0001). There was no group × time effect on other outcomes at 8 months, or on any outcomes at follow-up. The change in PWV at 8 months correlated with changes in insulin and insulin resistance (both r = 0.32), diastolic BP (r = 0.24), BMI (r = 0.22), and adiposity (r = 0.18).
CONCLUSIONS


Eight months of aerobic exercise training improved fitness, adiposity, and HDL-cholesterol levels, but did not reduce arterial stiffness in children with excess weight. PWV improved as a function of insulin resistance, BP, BMI, and adiposity. Weight loss may be required to improve arterial stiffness. Exercise benefits waned after discontinuing the program.",2020,"Compared with controls, the exercise group had twice the improvement in fitness (VȮ 2  peak, 2.7 (95% CI 1.8, 3.6) vs. 1.3 (0.4, 2.3) mL/kg/min) and adiposity (-1.8 (-2.4, -1.1) vs. -0.8 (-1.5, -0.1)%), each p = 0.04, and a large improvement in HDL-cholesterol (0.13 (0.075, 0.186) vs. -0.028 (-0.083, 0.023) mmol/L, p < 0.0001).","['children', 'children with excess weight', 'The study had 89% retention, with attendance of 59% in exercise and 64% in the control condition, and vigorous exercise participation (average heart rate 161\u2009±\u20097 beats/min', 'One hundred and seventy-five inactive children with overweight or obesity (8-11 years, ≥85th percentile BMI, 61% female, 87% Black, 73% with obesity']","['school aerobic exercise program (40\u2009min/day, n\u2009=\u200990) or a sedentary control condition', 'aerobic exercise training']","['insulin and insulin resistance', 'Adiposity, fitness, and BP', 'arterial stiffness', 'function of insulin resistance, BP, BMI, and adiposity', 'fitness, adiposity, and HDL-cholesterol levels', 'Weight loss', 'HDL-cholesterol', 'adiposity', 'arterial stiffness and heart health', 'diastolic BP', 'BMI', 'Carotid-femoral pulse wave velocity (PWV, primary outcome, arterial stiffness), fitness, adiposity, blood pressure (BP), glucose, insulin resistance, lipids, and C-reactive protein', 'change in PWV']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0439385', 'cui_str': 'beats per minute'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0556973', 'cui_str': 'mins/day'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C1563743', 'cui_str': 'Adiposis'}, {'cui': 'C0599949', 'cui_str': 'Arterial Stiffness'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol, HDL2'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0232148', 'cui_str': 'Femoral pulse, function (observable entity)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",175.0,0.0968893,"Compared with controls, the exercise group had twice the improvement in fitness (VȮ 2  peak, 2.7 (95% CI 1.8, 3.6) vs. 1.3 (0.4, 2.3) mL/kg/min) and adiposity (-1.8 (-2.4, -1.1) vs. -0.8 (-1.5, -0.1)%), each p = 0.04, and a large improvement in HDL-cholesterol (0.13 (0.075, 0.186) vs. -0.028 (-0.083, 0.023) mmol/L, p < 0.0001).","[{'ForeName': 'Catherine L', 'Initials': 'CL', 'LastName': 'Davis', 'Affiliation': 'Georgia Prevention Institute, Medical College of Georgia (MCG), Augusta University, Augusta, GA, USA. katie.davis@augusta.edu.'}, {'ForeName': 'Sheldon E', 'Initials': 'SE', 'LastName': 'Litwin', 'Affiliation': 'Cardiology, Medicine, MCG, Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Norman K', 'Initials': 'NK', 'LastName': 'Pollock', 'Affiliation': 'Georgia Prevention Institute, Medical College of Georgia (MCG), Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Waller', 'Affiliation': 'Population Health Sciences, MCG, Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Haidong', 'Initials': 'H', 'LastName': 'Zhu', 'Affiliation': 'Georgia Prevention Institute, Medical College of Georgia (MCG), Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Yanbin', 'Initials': 'Y', 'LastName': 'Dong', 'Affiliation': 'Georgia Prevention Institute, Medical College of Georgia (MCG), Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Gaston', 'Initials': 'G', 'LastName': 'Kapuku', 'Affiliation': 'Georgia Prevention Institute, Medical College of Georgia (MCG), Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Jigar', 'Initials': 'J', 'LastName': 'Bhagatwala', 'Affiliation': 'Georgia Prevention Institute, Medical College of Georgia (MCG), Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Ryan A', 'Initials': 'RA', 'LastName': 'Harris', 'Affiliation': 'Georgia Prevention Institute, Medical College of Georgia (MCG), Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Looney', 'Affiliation': 'Georgia Prevention Institute, Medical College of Georgia (MCG), Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Celestine F', 'Initials': 'CF', 'LastName': 'Williams', 'Affiliation': 'Georgia Prevention Institute, Medical College of Georgia (MCG), Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Aubrey', 'Initials': 'A', 'LastName': 'Armento', 'Affiliation': 'Georgia Prevention Institute, Medical College of Georgia (MCG), Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Schmidt', 'Affiliation': 'Kinesiology, University of Georgia, Athens, GA, USA.'}, {'ForeName': 'Reda', 'Initials': 'R', 'LastName': 'Bassali', 'Affiliation': 'Pediatrics, MCG, Augusta University, Augusta, GA, USA.'}]",International journal of obesity (2005),['10.1038/s41366-019-0482-1']
714,31754852,Three-dimensional versus two-dimensional high-definition laparoscopy in transabdominal preperitoneal inguinal hernia repair: a prospective randomized controlled study.,"BACKGROUND


Three-dimensional (3D) laparoscopy improves technical efficacy in laboratory environment, but evidence for clinical benefit is lacking. The aim of this study was to determine whether the 3D laparoscopy is beneficial in transabdominal preperitoneal laparoscopic inguinal hernia repair (TAPP).
METHOD


In this prospective, single-blinded, single-center, superior randomized trial, patients scheduled for TAPP were randomly allocated to either 3D or two-dimensional (2D) TAPP laparoscopic approaches. Patients were excluded if secondary operation was planned, the risk of conversion was high, or the surgeon had less than five previous 3D laparoscopic procedures. Patients were operated on by 13 residents and 3 attendings. The primary endpoint was operation time. The study was registered in ClinicalTrials.gov (NCT02367573).
RESULTS


Total 278 patients were randomized between 5th February 2015 and 23rd October 2017. Median operation time was shorter in the 3D group (56.0 min vs. 68.0 min, p < 0.001). 10 (8%) patients in 3D group and 6 (5%) patients in 2D group had clinically significant complications (Clavien-Dindo 2 or higher) (p = 0.440). Rate of hernia recurrence was similar between groups at 1-year follow-up. In the subgroup analyses, operation time was shorter in 3D laparoscopy among attendings, residents, female surgeons, surgeons with perfect stereovision, surgeons with > 50 3D laparoscopic procedures, surgeons with any experience in TAPP, patients with body mass indices < 30, and bilateral inguinal hernia repairs.
CONCLUSION


3D laparoscopy is beneficial and shortens operation time but does not affect safety or long-term outcomes of TAPP.",2020,"In the subgroup analyses, operation time was shorter in 3D laparoscopy among attendings, residents, female surgeons, surgeons with perfect stereovision, surgeons with > 50 3D laparoscopic procedures, surgeons with any experience in TAPP, patients with body mass indices < 30, and bilateral inguinal hernia repairs.
","['Total 278 patients were randomized between 5th February 2015 and 23rd October 2017', 'patients scheduled for TAPP', 'Patients were excluded if secondary operation was planned, the risk of conversion was high, or the surgeon had less than five previous 3D laparoscopic procedures', 'Patients were operated on by 13 residents and 3 attendings']","['3D or two-dimensional (2D) TAPP laparoscopic approaches', 'transabdominal preperitoneal laparoscopic inguinal hernia repair (TAPP', '3D laparoscopy', 'Three-dimensional versus two-dimensional high-definition laparoscopy', 'transabdominal preperitoneal inguinal hernia repair']","['Median operation time', 'Rate of hernia recurrence', 'operation time']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205439', 'cui_str': 'Fifth (qualifier value)'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0163807', 'cui_str': 'tetra-4-amidinophenoxypropane'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0439836', 'cui_str': 'Conversions (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0521291', 'cui_str': 'Laparoscopic-assisted procedure'}]","[{'cui': 'C0163807', 'cui_str': 'tetra-4-amidinophenoxypropane'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0205496', 'cui_str': 'Abdominal approach (qualifier value)'}, {'cui': 'C0442170', 'cui_str': 'Preperitoneal approach (qualifier value)'}, {'cui': 'C0021446', 'cui_str': 'Repair of inguinal hernia (procedure)'}, {'cui': 'C0031150', 'cui_str': 'Celioscopy'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C3539107', 'cui_str': 'Definition (core metadata concept)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}]",278.0,0.257996,"In the subgroup analyses, operation time was shorter in 3D laparoscopy among attendings, residents, female surgeons, surgeons with perfect stereovision, surgeons with > 50 3D laparoscopic procedures, surgeons with any experience in TAPP, patients with body mass indices < 30, and bilateral inguinal hernia repairs.
","[{'ForeName': 'Hanna E', 'Initials': 'HE', 'LastName': 'Koppatz', 'Affiliation': 'Department of Abdominal Surgery, Helsinki University Hospital and University of Helsinki, Haartmaninkatu 4, 00029, Helsinki, Finland.'}, {'ForeName': 'Jukka I', 'Initials': 'JI', 'LastName': 'Harju', 'Affiliation': 'Department of Abdominal Surgery, Helsinki University Hospital and University of Helsinki, Haartmaninkatu 4, 00029, Helsinki, Finland.'}, {'ForeName': 'Jukka E', 'Initials': 'JE', 'LastName': 'Sirén', 'Affiliation': 'Department of Abdominal Surgery, Helsinki University Hospital and University of Helsinki, Haartmaninkatu 4, 00029, Helsinki, Finland.'}, {'ForeName': 'Panu J', 'Initials': 'PJ', 'LastName': 'Mentula', 'Affiliation': 'Department of Abdominal Surgery, Helsinki University Hospital and University of Helsinki, Haartmaninkatu 4, 00029, Helsinki, Finland.'}, {'ForeName': 'Tom M', 'Initials': 'TM', 'LastName': 'Scheinin', 'Affiliation': 'Department of Abdominal Surgery, Helsinki University Hospital and University of Helsinki, Haartmaninkatu 4, 00029, Helsinki, Finland.'}, {'ForeName': 'Ville J', 'Initials': 'VJ', 'LastName': 'Sallinen', 'Affiliation': 'Department of Abdominal Surgery, Helsinki University Hospital and University of Helsinki, Haartmaninkatu 4, 00029, Helsinki, Finland. ville.sallinen@helsinki.fi.'}]",Surgical endoscopy,['10.1007/s00464-019-07266-z']
715,31735996,Effect of eccentric-based rehabilitation on hand tremor intensity in Parkinson disease.,"BACKGROUND AND PURPOSE


Hand tremor is a disturbing yet sometimes resistant symptom in persons with Parkinson disease (PD). Although many exercise regimens for these people have gained attention in recent years, the effect of resistance training and especially eccentric training on parkinsonian tremor is still uncertain. This study was conducted to investigate the precise effect of upper limb eccentric training on hand tremor in PD.
METHODS


In this randomized controlled trial, a consecutive sample of 21 persons with PD recruited from general hospitals went through 6 weeks of upper limb pure eccentric training as the intervention group (n = 11) or no additional exercise during this period as the control group (n = 10). Resting and postural tremor amplitudes were measured with the cellphone-based accelerometer.
RESULTS


Comparing hand tremor amplitudes before and after the trial showed a significant reduction in resting tremor amplitude in the intervention group after exercise sessions (p < 0.05) while detecting no changes in the control group during 6 weeks of study. Meanwhile, postural tremor amplitude remained unchanged in both groups.",2020,"RESULTS


Comparing hand tremor amplitudes before and after the trial showed a significant reduction in resting tremor amplitude in the intervention group after exercise sessions (p < 0.05) while detecting no changes in the control group during 6 weeks of study.","['21 persons with PD recruited from general hospitals went through 6 weeks of', 'persons with Parkinson disease (PD', 'Parkinson disease']","['eccentric-based rehabilitation', 'eccentric training', 'upper limb pure eccentric training as the intervention group (n = 11) or no additional exercise', 'upper limb eccentric training']","['resting tremor amplitude', 'Resting and postural tremor amplitudes', 'Meanwhile, postural tremor amplitude']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}]","[{'cui': 'C0439740', 'cui_str': 'Eccentric (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0234379', 'cui_str': 'Resting Tremor'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0234378', 'cui_str': 'Static Tremor'}]",21.0,0.0179724,"RESULTS


Comparing hand tremor amplitudes before and after the trial showed a significant reduction in resting tremor amplitude in the intervention group after exercise sessions (p < 0.05) while detecting no changes in the control group during 6 weeks of study.","[{'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Kadkhodaie', 'Affiliation': 'Neuromusculoskeletal Research Center, Department of Physical Medicine and Rehabilitation, Iran University of Medical Sciences, Firoozgar Hospital, Behafarin St., Karim Khan St., Tehran, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Sharifnezhad', 'Affiliation': 'Department of Sport Biomechanics and Technology, Sport Sciences Research Institute, No 3, Alley 5, Mir Emad St., Motahari St., Tehran, Iran. a.sharifnezhad@ssrc.ac.ir.'}, {'ForeName': 'Safoora', 'Initials': 'S', 'LastName': 'Ebadi', 'Affiliation': 'Neuromusculoskeletal Research Center, Department of Physical Medicine and Rehabilitation, Iran University of Medical Sciences, Firoozgar Hospital, Behafarin St., Karim Khan St., Tehran, Iran.'}, {'ForeName': 'Sadegh', 'Initials': 'S', 'LastName': 'Marzban', 'Affiliation': 'Department of Biomedical Engineering, Amirkabir University of Technology, Tehran, Iran.'}, {'ForeName': 'Seyed Amirhassan', 'Initials': 'SA', 'LastName': 'Habibi', 'Affiliation': 'Department of Neurology, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Amin', 'Initials': 'A', 'LastName': 'Ghaffari', 'Affiliation': 'School of Rehabilitation Science, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Bijan', 'Initials': 'B', 'LastName': 'Forogh', 'Affiliation': 'Neuromusculoskeletal Research Center, Department of Physical Medicine and Rehabilitation, Iran University of Medical Sciences, Firoozgar Hospital, Behafarin St., Karim Khan St., Tehran, Iran. bijanfr@gmail.com.'}]",Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology,['10.1007/s10072-019-04106-9']
716,31755993,Results of phase 2 trials exploring the safety and efficacy of omiganan in patients with human papillomavirus-induced genital lesions.,"AIMS


To assess safety and tolerability and explore pharmacodynamics and efficacy of omiganan in external anogenital warts (AGW) and vulvar high-grade squamous intraepithelial lesions (HSIL).
METHODS


Two randomized controlled trials in patients with external AGW and vulvar HSIL were conducted. Patients received topical omiganan 2.5% or placebo gel once daily for 12 weeks with a follow-up of 12 weeks. Safety and tolerability were monitored and pharmacodynamics and clinical efficacy of omiganan were assessed by analysing lesion count, size and viral load. Self-reported pain, itch and quality of life were assessed by an electronic diary and questionnaire.
RESULTS


Twenty-four AGW and 12 vulvar HSIL patients were enrolled. All patients had a high treatment adherence (99%). No serious adverse events occurred and all adverse events (n = 27) were mild, transient and self-limiting. The treatment groups were not different in terms of safety and tolerability, lesion count and size, and patient-reported outcomes pain, itch and quality of life. Human papillomavirus load significantly reduced after 12 weeks of treatment with omiganan compared to placebo (-96.6%; 95% confidence interval -99.9 to -7.4%; P = .045) in AGW patients only.
CONCLUSION


Topical omiganan appears to be safe in patients with AGW and vulvar HSIL and reduced human papillomavirus load after 12 weeks of treatment in AGW patients.",2019,"HPV load significantly reduced after 12 weeks of treatment with omiganan compared to placebo (-96.6%; 95% CI -99.9 to - 7.4%; p=0.045) in AGW patients only.
","['external anogenital warts (AGW) and vulvar high-grade squamous intraepithelial lesions (HSIL', 'patients with external anogenital warts and vulvar HSIL were conducted', 'Twenty-four AGW and 12 vulvar HSIL patients were enrolled', 'patients with human papillomavirus-induced genital lesions']","['placebo', 'omiganan', 'topical omiganan 2.5% or placebo gel']","['Self-reported pain, itch and quality of life', 'safety and efficacy of omiganan', 'HPV load', 'Safety and tolerability', 'lesion count, size and viral load', 'safety and tolerability, lesion count and size and patient-reported outcomes pain, itch and quality of life', 'serious adverse events', 'safety and tolerability']","[{'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0009663', 'cui_str': 'Warts, Venereal'}, {'cui': 'C0333875', 'cui_str': 'HSIL, High-Grade Squamous Intraepithelial Lesions'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0744369', 'cui_str': 'Lesion of genitalia'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4550028', 'cui_str': 'Omiganan'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C0034380'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4550028', 'cui_str': 'Omiganan'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.06831,"HPV load significantly reduced after 12 weeks of treatment with omiganan compared to placebo (-96.6%; 95% CI -99.9 to - 7.4%; p=0.045) in AGW patients only.
","[{'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Rijsbergen', 'Affiliation': 'Centre for Human Drug Research, Leiden, the Netherlands.'}, {'ForeName': 'Rianne', 'Initials': 'R', 'LastName': 'Rijneveld', 'Affiliation': 'Centre for Human Drug Research, Leiden, the Netherlands.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Todd', 'Affiliation': 'Centre for Human Drug Research, Leiden, the Netherlands.'}, {'ForeName': 'Gary L', 'Initials': 'GL', 'LastName': 'Feiss', 'Affiliation': 'Cutanea Life Sciences, Wayne, Pennsylvania, USA.'}, {'ForeName': 'Stijn T P', 'Initials': 'STP', 'LastName': 'Kouwenhoven', 'Affiliation': 'Department of Dermatology,, Leiden University Medical Centre, Leiden, the Netherlands.'}, {'ForeName': 'Koen D', 'Initials': 'KD', 'LastName': 'Quint', 'Affiliation': 'Department of Dermatology,, Leiden University Medical Centre, Leiden, the Netherlands.'}, {'ForeName': 'Dirk C J G', 'Initials': 'DCJG', 'LastName': 'van Alewijk', 'Affiliation': 'DDL Diagnostic Laboratory, Rijswijk, the Netherlands.'}, {'ForeName': 'Maurits N C', 'Initials': 'MNC', 'LastName': 'de Koning', 'Affiliation': 'DDL Diagnostic Laboratory, Rijswijk, the Netherlands.'}, {'ForeName': 'Erica S', 'Initials': 'ES', 'LastName': 'Klaassen', 'Affiliation': 'Centre for Human Drug Research, Leiden, the Netherlands.'}, {'ForeName': 'Jacobus', 'Initials': 'J', 'LastName': 'Burggraaf', 'Affiliation': 'Centre for Human Drug Research, Leiden, the Netherlands.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Rissmann', 'Affiliation': 'Centre for Human Drug Research, Leiden, the Netherlands.'}, {'ForeName': 'Mariëtte I E', 'Initials': 'MIE', 'LastName': 'van Poelgeest', 'Affiliation': 'Centre for Human Drug Research, Leiden, the Netherlands.'}]",British journal of clinical pharmacology,['10.1111/bcp.14181']
717,29754649,Telemedicine cardiovascular risk reduction in veterans: The CITIES trial.,"BACKGROUND


Comprehensive programs addressing tailored patient self-management and pharmacotherapy may reduce barriers to cardiovascular disease (CVD) risk reduction.
METHODS


This is a 2-arm (clinical pharmacist specialist-delivered, telehealth intervention and education control) randomized controlled trial including Veterans with poorly controlled hypertension and/or hypercholesterolemia. Primary outcome was Framingham CVD risk score at 6 and 12 months, with systolic blood pressure; diastolic blood pressure; total cholesterol; low-density lipoprotein; high-density lipoprotein; body mass index; and, for those with diabetes, HbA1c as secondary outcomes.
RESULTS


Among 428 Veterans, 50% were African American, 85% were men, and 33% had limited health literacy. Relative to the education control group, the clinical pharmacist specialist-delivered intervention did not show a reduction in CVD risk score at 6 months (-1.8, 95% CI -3.9 to 0.3; P = .10) or 12 months (-0.3, 95% CI -2.4 to 1.7; P = .74). No differences were seen in systolic blood pressure, diastolic blood pressure, or low-density lipoprotein at 6 or 12 months. We did observe a significant decline in total cholesterol at 6 months (-7.0, 95% CI -13.4 to -0.6; P = .03) in the intervention relative to education control group. Among patients in the intervention group, 34% received at least 5 of the 12 planned intervention calls and were considered ""compliers."" A sensitivity analysis of the ""complier average causal effect"" of intervention compared to control showed a mean difference in CVD risk score reduction of 5.7 (95% CI -12.0 to 0.7) at 6 months and -1.7 (95% CI -7.6 to 4.8) at 12 months.
CONCLUSIONS


Despite increased access to pharmacist resources, we did not observe significant improvements in CVD risk for patients randomized to the intervention compared to education control over 12 months. However, the intervention may have positive impact among those who actively participate, particularly in the short term.",2018,"Relative to the education control group, the clinical pharmacist specialist-delivered intervention did not show a reduction in CVD risk score at 6 months (-1.8, 95% CI -3.9 to 0.3; P = .10) or 12 months (-0.3, 95% CI -2.4 to 1.7; P = .74).","['Veterans with poorly controlled hypertension and/or hypercholesterolemia', 'veterans', '428 Veterans, 50% were African American, 85% were men, and 33% had limited health literacy']",[],"['CVD risk score reduction', 'systolic blood pressure, diastolic blood pressure, or low-density lipoprotein', 'Telemedicine cardiovascular risk reduction', 'CVD risk score', 'total cholesterol', 'Framingham CVD risk score at 6 and 12 months, with systolic blood pressure; diastolic blood pressure; total cholesterol; low-density lipoprotein; high-density lipoprotein; body mass index; and, for those with diabetes, HbA1c as secondary outcomes', 'CVD risk']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0020443', 'cui_str': 'High Cholesterol Levels'}, {'cui': 'C4517775', 'cui_str': 'Four hundred and twenty-eight'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}]",[],"[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}]",,0.100744,"Relative to the education control group, the clinical pharmacist specialist-delivered intervention did not show a reduction in CVD risk score at 6 months (-1.8, 95% CI -3.9 to 0.3; P = .10) or 12 months (-0.3, 95% CI -2.4 to 1.7; P = .74).","[{'ForeName': 'Hayden B', 'Initials': 'HB', 'LastName': 'Bosworth', 'Affiliation': 'Health Services Research in Primary Care, Center of Innovation, Durham Veterans Affairs Medical Center, Durham, NC; Center for Population Health Sciences, Duke University, Durham, NC; Division of General Internal Medicine, Duke University, Durham, NC; Departments of Psychiatry and School of Nursing, Duke University, Durham, NC. Electronic address: hayden.bosworth@duke.edu.'}, {'ForeName': 'Maren K', 'Initials': 'MK', 'LastName': 'Olsen', 'Affiliation': 'Health Services Research in Primary Care, Center of Innovation, Durham Veterans Affairs Medical Center, Durham, NC; Department of Biostatistics and Bioinformatics, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Felicia', 'Initials': 'F', 'LastName': 'McCant', 'Affiliation': 'Health Services Research in Primary Care, Center of Innovation, Durham Veterans Affairs Medical Center, Durham, NC.'}, {'ForeName': 'Karen M', 'Initials': 'KM', 'LastName': 'Stechuchak', 'Affiliation': 'Health Services Research in Primary Care, Center of Innovation, Durham Veterans Affairs Medical Center, Durham, NC.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Danus', 'Affiliation': 'Health Services Research in Primary Care, Center of Innovation, Durham Veterans Affairs Medical Center, Durham, NC.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Crowley', 'Affiliation': 'Health Services Research in Primary Care, Center of Innovation, Durham Veterans Affairs Medical Center, Durham, NC.'}, {'ForeName': 'Karen M', 'Initials': 'KM', 'LastName': 'Goldstein', 'Affiliation': 'Health Services Research in Primary Care, Center of Innovation, Durham Veterans Affairs Medical Center, Durham, NC; Ambulatory Care Services, Durham Veterans Affairs Medical Center, Durham, NC.'}, {'ForeName': 'Leah L', 'Initials': 'LL', 'LastName': 'Zullig', 'Affiliation': 'Health Services Research in Primary Care, Center of Innovation, Durham Veterans Affairs Medical Center, Durham, NC; Center for Population Health Sciences, Duke University, Durham, NC.'}, {'ForeName': 'Eugene Z', 'Initials': 'EZ', 'LastName': 'Oddone', 'Affiliation': 'Health Services Research in Primary Care, Center of Innovation, Durham Veterans Affairs Medical Center, Durham, NC; Division of General Internal Medicine, Duke University, Durham, NC.'}]",American heart journal,['10.1016/j.ahj.2018.02.002']
718,31750922,Resources in vulnerable young adults: self-assessments during preventive consultation with their general practitioner in Denmark.,"Inequality in health is increasing. People with many problems often lack energy to improve well-being and reduce their problems. This study analyses how psycho-socially challenged younger (20- to 44-year-old) patients described their own resources to reach lifestyle goals or alter life circumstances. Within the context of a randomized controlled trial, Danish participants had two structured preventive person-centred consultations with their general practitioner. Consultations focused on well-being, salutogenesis, resources, barriers and support of autonomy. Using the qualitative method: Systematic Text Condensation, we made thematic cross-analysis of patients' goal-specific resource statements described at the first consultation. Of the 209 patients, 191 (91%) chose one or two goals for a better life next year; nearly all (179) could recall and describe which resources they would use to reach their goal. We categorized resource statements into (i) personal constitution as 'willpower' and 'tenacity'; (ii) network, e.g. family; (iii) personal experience with identical or similar problems. Some patients needed to free up resources by handling psychological problems before being able to focus on lifestyle goals. The study demonstrates that patients with particular psycho-social problems could describe essential resources in a structured, salutogenic, preventive consultation with their general practitioner. Reflecting intrinsic and extrinsic motivation, these resources reflected dimensions of essential health theories like sense of coherence, self-efficacy and self-determination theory. Increased awareness of these resources seems essential for vulnerable patients by improving psychological well-being and optimism, thereby facilitating health-related changes. This may be an important step to reducing inequality in health.",2020,"Increased awareness of these resources seems essential for vulnerable patients by improving psychological well-being and optimism, thereby facilitating health-related changes.","['patients with particular psycho-social problems', 'psycho-socially challenged younger (20- to 44-year-old) patients', 'Danish participants had two structured preventive person-centred consultations with their general practitioner', 'vulnerable young adults']",[],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0037431', 'cui_str': 'Social Problems'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1456501', 'cui_str': 'Preventive'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0017319', 'cui_str': 'Physicians, General Practice'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]",[],[],209.0,0.0259725,"Increased awareness of these resources seems essential for vulnerable patients by improving psychological well-being and optimism, thereby facilitating health-related changes.","[{'ForeName': 'Kirsten Schierup', 'Initials': 'KS', 'LastName': 'Freund', 'Affiliation': 'Center for General Practice, Aalborg University, Fyrkildevej 7, DK-9200 Aalborg Ø, Denmark.'}, {'ForeName': 'Ann Dorrit', 'Initials': 'AD', 'LastName': 'Guassora', 'Affiliation': 'The Research Unit and Section of General Practice, Department of Public Health, University of Copenhagen, Ø. Farimagsgade 5,opg.Q, DK-1014 Copenhagen, Denmark.'}, {'ForeName': 'Trine', 'Initials': 'T', 'LastName': 'Hegelund', 'Affiliation': 'Hovedgaden 43, DK-2970 Hoersholm, Denmark.'}, {'ForeName': 'Lotte', 'Initials': 'L', 'LastName': 'Hvas', 'Affiliation': 'The Research Unit and Section of General Practice, Department of Public Health, University of Copenhagen, Ø. Farimagsgade 5,opg.Q, DK-1014 Copenhagen, Denmark.'}, {'ForeName': 'Jørgen', 'Initials': 'J', 'LastName': 'Lous', 'Affiliation': 'Research Unit of General Practice, Southern University, J. B. Winsløvs Vej 9A, DK-5000 Odense, Denmark.'}]",Health promotion international,['10.1093/heapro/daz114']
719,31662387,Effects of a probiotic treatment ( Enterococcus faecalis ) and open-label placebo on symptoms of allergic rhinitis: study protocol for a randomised controlled trial.,"INTRODUCTION


Several studies suggest that gut microbiota may play an important role in allergic diseases. The present trial aims to examine effects of the probiotic  Enterococcus faecalis  on symptoms of allergic rhinitis in patients. Effects of this probiotic on the immune system have been reported by several studies, but the majority of the previous trials were animal studies. In addition, it is well known that symptoms in allergic rhinitis are prone to exhibit high placebo responses. Moreover, recent studies report that even placebos without deception (open-label placebos) are highly effective in reducing symptoms of allergic rhinitis. Our study design combines both new approaches to assess effects on allergic symptoms in patients. The objective of this study is to compare the effects of a probiotic treatment ( E. faecalis ) with effects seen by open-label placebo, concealed placebo treatment and no treatment control.
METHODS AND ANALYSIS


A total of 120 patients with allergic rhinitis will be randomly assigned to one of four different groups: a double-blind probiotic/placebo group (groups 1 and 2), an open-label placebo group (group 3) and a no-treatment group (group 4) to control for spontaneous variation of symptoms. The primary outcome is the evaluation of allergic symptoms using the Combined Symptoms Medication Score. Furthermore, health-related quality of life is examined (Rhinitis Quality of Life Questionnaire). Secondary outcomes include a visual analogue scale on allergic burden and a second quality of life questionnaire. This report describes the study design of the randomised controlled trial.
ETHICS AND DISSEMINATION


The study design was approved by the ethical committee of the UKT Department of Psychosomatic Medicine and Psychotherapy, Tübingen, Germany. The trial is registered at the German Clinical Trials Register (www.drks.de, DRKS00015804). The trial results will be published in peer-reviewed journals and at conferences.
TRIAL REGISTRATION NUMBER


German Clinical Trials Register (www.drks.de, DRKS00015804); Pre-results.",2019,"The study design was approved by the ethical committee of the UKT Department of Psychosomatic Medicine and Psychotherapy, Tübingen, Germany.","['patients', '120 patients with allergic rhinitis', 'allergic rhinitis in patients']","['probiotic treatment ( Enterococcus faecalis ) and open-label placebo', 'placebos without deception (open-label placebos', 'open-label placebo', 'probiotic  Enterococcus faecalis', 'probiotic treatment ( E. faecalis ', 'open-label placebo, concealed placebo', 'double-blind probiotic/placebo']","['evaluation of allergic symptoms using the Combined Symptoms Medication Score', 'allergic symptoms', 'visual analogue scale on allergic burden and a second quality of life questionnaire', 'symptoms of allergic rhinitis']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C2607914', 'cui_str': 'Rhinitis, Allergic'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0085494', 'cui_str': 'Enterococcus'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0024195', 'cui_str': 'Deception'}, {'cui': 'C0038404', 'cui_str': 'Enterococcus faecalis'}, {'cui': 'C0443189', 'cui_str': 'Concealed (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}]","[{'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2607914', 'cui_str': 'Rhinitis, Allergic'}]",120.0,0.45951,"The study design was approved by the ethical committee of the UKT Department of Psychosomatic Medicine and Psychotherapy, Tübingen, Germany.","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schaefer', 'Affiliation': 'Department Naturwissenschaften, Medical School Berlin, Berlin, Germany michael.schaefer@medicalschool-berlin.de.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Enck', 'Affiliation': 'Department of Internal Medicine VI: Psychosomatic Medicine and Psychotherapy, University of Tubingen, Tübingen, Germany.'}]",BMJ open,['10.1136/bmjopen-2019-031339']
720,31672709,Effects of intraoperative PEEP on postoperative pulmonary complications in high-risk patients undergoing laparoscopic abdominal surgery: study protocol for a randomised controlled trial.,"INTRODUCTION


Postoperative pulmonary complications (PPCs), strongly associated with higher mortality risk, can develop in up to 58% of patients undergoing abdominal surgery. More and more evidence shows that the use of a lung-protective ventilation strategy has a lung protection effect in patients undergoing abdominal surgery, however, the role of positive end-expiratory pressure (PEEP) during the intraoperative period in preventing PPCs for laparoscopic surgery is not clearly defined.
METHODS AND ANALYSIS


A total of 208 patients with a high risk of PPC, undergoing laparoscopic abdominal surgery, will be enrolled and randomised into a standard PEEP (6-8 cm H 2 O) group and a low PEEP (≤2 cm H 2 O) group. Both groups will receive a fraction of inspired oxygen of 0.50 and a tidal volume of 8 mL/kg ideal body weight (IBW). Standard perioperative fluid management and analgesic treatments are applied in both groups. The primary end point is PPC within 7 days after surgery. Secondary end points are the modified Clinical Pulmonary Infection Score, postoperative extrapulmonary complications, postoperative surgical complications, intensive care unit length of stay, hospital length of stay, 30-day mortality.
ETHICS AND DISSEMINATION


The study was approved by the Ethics Committee of Zhejiang Provincial People's Hospital (People's Hospital of Hangzhou Medicine College) (registration number KY2018026) on 22 October 2018. The first participant was recruited on 15 April 2019 and the estimated completion date of the study is October 2021. The results of this trial will be submitted to a peer-reviewed journal.
TRIAL REGISTRATION NUMBER


http://www.chictr.org.cn, ID: ChiCTR1800019865. Registered on 2 December 2018; preresults.",2019,"Secondary end points are the modified Clinical Pulmonary Infection Score, postoperative extrapulmonary complications, postoperative surgical complications, intensive care unit length of stay, hospital length of stay, 30-day mortality.
","['high-risk patients undergoing laparoscopic abdominal surgery', ""Zhejiang Provincial People's Hospital"", ""People's Hospital of Hangzhou Medicine College) (registration number KY2018026) on 22 October 2018"", '208 patients with a high risk of PPC, undergoing laparoscopic abdominal surgery', 'The first participant was recruited on 15 April 2019 and the estimated completion date of the study is October 2021', 'patients undergoing abdominal surgery']","['standard PEEP', 'low PEEP', 'intraoperative PEEP']","['modified Clinical Pulmonary Infection Score, postoperative extrapulmonary complications, postoperative surgical complications, intensive care unit length of stay, hospital length of stay, 30-day mortality', 'postoperative pulmonary complications']","[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0011008', 'cui_str': 'Dates'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0863179', 'cui_str': 'Peeping'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0876973', 'cui_str': 'Pulmonary infection'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}]",208.0,0.331691,"Secondary end points are the modified Clinical Pulmonary Infection Score, postoperative extrapulmonary complications, postoperative surgical complications, intensive care unit length of stay, hospital length of stay, 30-day mortality.
","[{'ForeName': 'Zhen-Feng', 'Initials': 'ZF', 'LastName': 'Zhou', 'Affiliation': 'Department of Anesthesiology, Zhejiang Provincial People,s Hospital (People,s Hospital of Hangzhou Medicine College), Hangzhou, China.'}, {'ForeName': 'Jun-Biao', 'Initials': 'JB', 'LastName': 'Fang', 'Affiliation': 'Department of Anesthesiology, Zhejiang Provincial People,s Hospital (People,s Hospital of Hangzhou Medicine College), Hangzhou, China.'}, {'ForeName': 'Hong-Fa', 'Initials': 'HF', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Zhejiang Provincial People,s Hospital (People,s Hospital of Hangzhou Medicine College), Hangzhou, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': 'Department of Anesthesiology, Zhejiang Provincial People,s Hospital (People,s Hospital of Hangzhou Medicine College), Hangzhou, China.'}, {'ForeName': 'Yong-Jian', 'Initials': 'YJ', 'LastName': 'Yu', 'Affiliation': 'Department of Anesthesiology, Zhejiang Provincial People,s Hospital (People,s Hospital of Hangzhou Medicine College), Hangzhou, China.'}, {'ForeName': 'Qiong', 'Initials': 'Q', 'LastName': 'Xu', 'Affiliation': 'Department of Anesthesiology, Zhejiang Provincial People,s Hospital (People,s Hospital of Hangzhou Medicine College), Hangzhou, China.'}, {'ForeName': 'Yun-Fen', 'Initials': 'YF', 'LastName': 'Ge', 'Affiliation': 'Department of Anesthesiology, Zhejiang Provincial People,s Hospital (People,s Hospital of Hangzhou Medicine College), Hangzhou, China.'}, {'ForeName': 'Miao-Zun', 'Initials': 'MZ', 'LastName': 'Zhang', 'Affiliation': 'General Surgery, Ningbo Medical center Lihuili Hospital, Ningbo, China.'}, {'ForeName': 'Shuang-Fei', 'Initials': 'SF', 'LastName': 'Hu', 'Affiliation': 'Department of Anesthesiology, Zhejiang Provincial People,s Hospital (People,s Hospital of Hangzhou Medicine College), Hangzhou, China hushuangfei77@sina.com.'}]",BMJ open,['10.1136/bmjopen-2018-028464']
721,31112399,Early onset of effect of onabotulinumtoxinA for chronic migraine treatment: Analysis of PREEMPT data.,"BACKGROUND


The Phase 3 REsearch Evaluating Migraine Prophylaxis Therapy (PREEMPT) trials demonstrated efficacy/tolerability of onabotulinumtoxinA for headache prevention in adults with chronic migraine. This post hoc analysis assessed time of onset of onabotulinumtoxinA after the first treatment in total and responder populations and consistency weekly through five treatment cycles.
METHODS


In the 24-week, double-blind, placebo-controlled phase of PREEMPT, individuals were randomized 1:1 to onabotulinumtoxinA (155-195 U) or placebo every 12 weeks for two cycles. The primary pooled efficacy variable was change in headache days per 28 days at week 24. We assessed change in headache and migraine/probable migraine (hereafter migraine) days/week compared with baseline week 4.
RESULTS


Baseline mean (SD) headache days/week (week 4 of baseline) for onabotulinumtoxinA (n = 688) and placebo (n = 696) were similar (4.8 [1.6] vs. 4.8 [1.6] days/week, respectively), as were migraine days/week (4.6 [1.7] vs. 4.6 [1.7] days/week). The effect of onabotulinumtoxinA on change in headache and migraine days/week was significantly greater than placebo at week 1, persisting from week 3 after the first treatment (-1.6 [2.2] vs. -1.1 [2.2] headache days/week [  p  < 0.001] and -1.6 [2.2] vs. -1.1 [2.2] migraine days/week [  p  < 0.001]). Headache and migraine days decreased in onabotulinumtoxinA responders beginning 1 week after treatment 1.
CONCLUSIONS


Treatment with onabotulinumtoxinA is associated with significant reductions in headache and migraine days/week at week 1, persisting after week 3, compared with placebo. Combined with earlier reports showing onabotulinumtoxinA treatment results in a persistent and progressive reduction in headache days over 56 weeks, it is suggested peak benefit may require multiple treatments.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov: NCT00156910 and NCT00168428.",2019,"The effect of onabotulinumtoxinA on change in headache and migraine days/week was significantly greater than placebo at week 1, persisting from week 3 after the first treatment (-1.6 [2.2] vs. -1.1 [2.2] headache days/week [  p  < 0.001] and -1.6 [2.2] vs. -1.1 [2.2] migraine days/week",['adults with chronic migraine'],"['placebo', 'Migraine Prophylaxis Therapy (PREEMPT', 'onabotulinumtoxinA']","['headache days', 'time of onset of onabotulinumtoxinA', 'headache and migraine/probable migraine', 'Baseline mean (SD) headache', 'headache', 'headache and migraine days/week', 'Headache and migraine days']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1960870', 'cui_str': 'Chronic migraine'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1142085', 'cui_str': 'Migraine prophylaxis (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0676278', 'cui_str': 'preempt'}, {'cui': 'C2719767', 'cui_str': 'onabotulinumtoxinA'}]","[{'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0449244', 'cui_str': 'Time of onset (observable entity)'}, {'cui': 'C2719767', 'cui_str': 'onabotulinumtoxinA'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0677547', 'cui_str': 'days/week (qualifier value)'}]",696.0,0.232294,"The effect of onabotulinumtoxinA on change in headache and migraine days/week was significantly greater than placebo at week 1, persisting from week 3 after the first treatment (-1.6 [2.2] vs. -1.1 [2.2] headache days/week [  p  < 0.001] and -1.6 [2.2] vs. -1.1 [2.2] migraine days/week","[{'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Dodick', 'Affiliation': '1 Deparment of Neurology, Mayo Clinic, Phoenix, AZ, USA.'}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Silberstein', 'Affiliation': '2 Jefferson Headache Center, Philadelphia, PA, USA.'}, {'ForeName': 'Richard B', 'Initials': 'RB', 'LastName': 'Lipton', 'Affiliation': '3 Montefiore Headache Center and Albert Einstein College of Medicine, Bronx, NY, USA.'}, {'ForeName': 'Ronald E', 'Initials': 'RE', 'LastName': 'DeGryse', 'Affiliation': '4 Allergan plc, Irvine, CA, USA.'}, {'ForeName': 'Aubrey Manack', 'Initials': 'AM', 'LastName': 'Adams', 'Affiliation': '4 Allergan plc, Irvine, CA, USA.'}, {'ForeName': 'Hans-Christoph', 'Initials': 'HC', 'LastName': 'Diener', 'Affiliation': '5 University of Duisbury-Essen, Essen, Germany.'}]",Cephalalgia : an international journal of headache,['10.1177/0333102418825382']
722,31096265,The Relationship of Varenicline Agonism of α4β2 Nicotinic Acetylcholine Receptors and Nicotine-Induced Dopamine Release in Nicotine-Dependent Humans.,"INTRODUCTION


Cigarette smoking continues to be one of the most important behavioral causes of morbidity and mortality in the world. Varenicline, an α4β2 nicotinic acetylcholine receptor (nAChR) partial agonist, has been shown to increase smoking quit rates compared with nicotine-based products. This human laboratory, double-blind, placebo-controlled study examined varenicline and placebo effects on α4β2-nAChRs occupancy, nicotine-induced change in [11C]raclopride non-displaceable binding potential (BPND), and behavioral measures of cigarette smoking, nicotine craving, and withdrawal.
METHODS


Current nicotine dependent daily smokers (N = 17) were randomized to varenicline 1 mg twice daily or placebo for 13 days. Using positron emission tomography), we characterized α4β2-nAChRs occupancy using [18F]AZAN and dopamine receptor binding using [11C]raclopride as well as behavioral measures of cigarettes smoked, craving, and nicotine withdrawal.
RESULTS


Varenicline compared with placebo resulted in significant reductions in [18F]AZAN BPND in multiple brain regions including thalamus, midbrain, putamen, and ventral striatum. Following administration of a controlled-dose nicotine cigarette, dopamine release was significantly suppressed in the ventral striatum in the varenicline-treated compared with the placebo group. There was a significant relationship between α4β2-nAChRs BPND measured in thalamus during the [18F]AZAN scan and nicotine-induced change in raclopride BPND in the ventral striatum.
CONCLUSION


This is the first human study to demonstrate a direct relationship between the extent of varenicline occupancy of α4β2-nAChRs and the magnitude of dopamine release following nicotine use.
IMPLICATIONS


It has remained unclear how nicotinic receptor blockade through partial agonist medications such as varenicline promotes smoking cessation. One hypothesized mechanism is downstream dampening of the mesolimbic reward dopamine system. For the first time in human smokers, we observed a direct relationship between the extent of varenicline blockade of α4β2-nACh nicotinic receptors and the magnitude of dopamine release following smoking. This has mechanistic and therapeutic implications for improving smoking cessation interventions.",2020,"RESULTS


Varenicline compared with placebo resulted in significant reductions in [18F]AZAN BPND in multiple brain regions including thalamus, midbrain, putamen and ventral striatum.","['Current nicotine dependent, daily smokers (N=17', 'human smokers']","['Varenicline', 'placebo', 'varenicline 1 mg twice daily or placebo', 'varenicline and placebo', 'positron emission tomography (PET']","['18F]AZAN BPND in multiple brain regions including thalamus, midbrain, putamen and ventral striatum', 'α4β2-nAChRs occupancy, nicotine-induced change in [11C]raclopride binding potential (BPND) and behavioral measures of cigarette smoking, nicotine craving, and withdrawal', 'ventral striatum', 'raclopride BPND', 'smoking quit rates', 'α4β2-nAChRs BPND']","[{'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1712046', 'cui_str': 'varenicline 1 MG [Chantix]'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0032743', 'cui_str': 'Positron-Emission Tomography'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C1273723', 'cui_str': 'Brain region'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0039729', 'cui_str': 'Thalamencephalon'}, {'cui': 'C0025462', 'cui_str': 'Midbrain'}, {'cui': 'C0034169', 'cui_str': 'Nucleus Putamen'}, {'cui': 'C0750950', 'cui_str': 'Ventral Striatum'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0072953', 'cui_str': 'Raclopride'}, {'cui': 'C1145667', 'cui_str': 'Binding - action (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0700219', 'cui_str': 'Cigarette Smoking'}, {'cui': 'C0872355', 'cui_str': 'Nicotine craving'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}]",17.0,0.0570948,"RESULTS


Varenicline compared with placebo resulted in significant reductions in [18F]AZAN BPND in multiple brain regions including thalamus, midbrain, putamen and ventral striatum.","[{'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'McCaul', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Gary S', 'Initials': 'GS', 'LastName': 'Wand', 'Affiliation': 'Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Hiroto', 'Initials': 'H', 'LastName': 'Kuwabara', 'Affiliation': 'Department of Radiology, Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Dannals', 'Affiliation': 'Department of Radiology, Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Wong', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Xiaoqiang', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz080']
723,31140663,Effects of immediate versus gradual nicotine reduction in cigarettes on biomarkers of biological effects.,"AIM


A previous study showed significantly greater reductions in number of cigarettes smoked and biomarkers of toxicant and carcinogen exposure in smokers assigned to immediate reduction of nicotine in cigarettes to very low levels versus gradually over time or continued smoking of normal nicotine content cigarettes. This study examines the effects of these approaches on selected biomarkers associated with harmful biological effects.
DESIGN


Three-arm, randomized controlled trial.
SETTING


Ten United States academic institutional sites.
PARTICIPANTS


Daily smokers uninterested in quitting smoking with a mean age of 45.1 [standard deviation (SD) = 13.4)] years and smoking 17.1 (SD = 8.5) cigarettes/day; 43.9% (549 of 1250) female; 60.6% (758 of 1250) white ethnicity.
INTERVENTIONS


(1) Smoking cigarettes where nicotine content was immediately reduced to very low levels (n = 503); (2) smoking cigarettes where nicotine content was gradually reduced, with dose changes occurring monthly (n = 498); and (3) continued smoking with normal nicotine content cigarettes (n = 249).
MEASUREMENTS


Smokers were assessed at baseline while smoking their usual brand cigarettes, and again at 4, 8, 12, 16 and 20 weeks. Outcomes were areas under the concentration time curve (AUC) for the period of study of biomarkers of inflammation, oxidative stress and hematological parameters.
FINDINGS


No consistent significant differences were observed across groups (Bayes factors showing data to be insensitive), with the only exception being red blood cell size variability, which was observed to be lower in the immediate versus gradual nicotine reduction [mean difference =  -0.11; 95% confidence interval (CI) = -0.18, -0.04, P = 0.004] and normal nicotine control groups (mean difference = - 0.15, 95% CI = -0.23, -0.06, P = 0.001).
CONCLUSION


It remains unclear whether switching to very low nicotine cigarettes leads to a short-term reduction in biomarkers of tobacco-related harm.",2019,"No consistent significant differences were observed across groups (Bayes factors showing data to be insensitive), with the only exception being red blood cell size variability, which was observed to be lower in the immediate versus gradual nicotine reduction [mean difference =  ","['Daily smokers uninterested in quitting smoking with a mean age of 45.1 [standard deviation (SD)\xa0=\xa013.4)] years and smoking 17.1 (SD\xa0=\xa08.5) cigarettes/day; 43.9% (549 of 1250) female; 60.6% (758 of 1250) white ethnicity', 'Ten United States academic institutional sites']","['nicotine', 'normal nicotine content cigarettes', 'immediate versus gradual nicotine']","['concentration time curve (AUC', 'red blood cell size variability', 'inflammation, oxidative stress and hematological parameters']","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C4517558', 'cui_str': 'Thirteen point four'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C4517554', 'cui_str': 'One thousand two hundred and fifty'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0243103', 'cui_str': 'ethnicity'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0439833', 'cui_str': 'Gradual (qualifier value)'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0427488', 'cui_str': 'Red blood cell size - finding'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.0303464,"No consistent significant differences were observed across groups (Bayes factors showing data to be insensitive), with the only exception being red blood cell size variability, which was observed to be lower in the immediate versus gradual nicotine reduction [mean difference =  ","[{'ForeName': 'Dorothy K', 'Initials': 'DK', 'LastName': 'Hatsukami', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Xianghua', 'Initials': 'X', 'LastName': 'Luo', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Alisa K', 'Initials': 'AK', 'LastName': 'Heskin', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Mei Kuen', 'Initials': 'MK', 'LastName': 'Tang', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Steven G', 'Initials': 'SG', 'LastName': 'Carmella', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Joni', 'Initials': 'J', 'LastName': 'Jensen', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Jason D', 'Initials': 'JD', 'LastName': 'Robinson', 'Affiliation': 'Department of Behavioral Science, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Vandrey', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Drobes', 'Affiliation': 'Moffitt Cancer Center, Department of Health Outcomes and Behavior, Tampa, FL, USA.'}, {'ForeName': 'Andrew A', 'Initials': 'AA', 'LastName': 'Strasser', 'Affiliation': 'Department of Psychiatry, Philadelphia, University of Pennsylvania, PA, USA.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': ""al'Absi"", 'Affiliation': 'Behavioral Medicine Laboratories, University of Minnesota Medical School, Duluth, MN, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Leischow', 'Affiliation': 'Mayo Clinic, Health Sciences Research, Scottsdale, AZ, USA.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Cinciripini', 'Affiliation': 'Department of Behavioral Science, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Koopmeiners', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Ikuemonisan', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Neal L', 'Initials': 'NL', 'LastName': 'Benowitz', 'Affiliation': 'Department of Medicine, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Eric C', 'Initials': 'EC', 'LastName': 'Donny', 'Affiliation': 'Department of Physiology and Pharmacology, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Stephen S', 'Initials': 'SS', 'LastName': 'Hecht', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis, MN, USA.'}]","Addiction (Abingdon, England)",['10.1111/add.14695']
724,30519766,Effects of omega-3 fatty acids on metabolic syndrome in patients with schizophrenia: a 12-week randomized placebo-controlled trial.,"RATIONALE


Individuals with schizophrenia are at increased risk of developing metabolic syndrome (MetS) due to their lifestyle and antipsychotic treatment. Our previous study showed that patients with both schizophrenia and MetS present an increased expression and production of tumor necrosis factor-alpha (TNF-alpha). Omega-3 fatty acids have a documented role in suppressing TNF-alpha; therefore, we hypothesized that they may be of value in relieving inflammation and improving metabolic disturbance in patients with both schizophrenia and MetS.
OBJECTIVES


This study employed a randomized placebo-controlled trial to investigate the effects of omega-3 fatty acids on MetS in patients with schizophrenia.
METHODS


We recruited 80 patients with both schizophrenia and MetS who received long-term olanzapine monotherapy. The patients were randomly assigned to the OMG-3 group (n = 40) or the placebo group (n = 40).
RESULTS


Patients with both schizophrenia and MetS had significantly higher levels of TNF-alpha than the control subjects (Z = - 4.37, P < 0.01). There was a significant correlation between omega-3 fatty acid treatment and reduced triglyceride (TG) levels (F group × time  = 13.42; df = 1, 66; P < 0.01) when the patients completed this study. Along with metabolic improvement, omega-3 fatty acids decreased TNF-alpha levels after 12 weeks of treatment (F group × time  = 6.71; df = 1, 66; P = 0.012). We also found that the extent of TNF-alpha decrease was significantly correlated with that of TG decrease (r = 0.38, P = 0.001).
CONCLUSIONS


Our findings provide suggestive evidence that omega-3 fatty acids have beneficial effects on TG metabolism in patients with both schizophrenia and MetS that parallel decreased inflammation levels.",2019,"Along with metabolic improvement, omega-3 fatty acids decreased TNF-alpha levels after 12 weeks of treatment (F group × time  = 6.71; df = 1, 66; P = 0.012).","['patients with both schizophrenia and MetS.\nOBJECTIVES', 'Individuals with schizophrenia', 'patients with schizophrenia', '80 patients with both schizophrenia and MetS who received long-term']","['placebo', 'olanzapine monotherapy', 'Omega-3 fatty acids', 'OMG-3', 'omega-3 fatty acids']","['omega-3 fatty acid treatment and reduced triglyceride (TG) levels', 'metabolic syndrome', 'TG metabolism', 'omega-3 fatty acids decreased TNF-alpha levels', 'expression and production of tumor necrosis factor-alpha (TNF-alpha', 'TNF-alpha decrease', 'levels of TNF-alpha']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}]","[{'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0428475', 'cui_str': 'Triglyceride level - finding'}, {'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0033268'}]",80.0,0.0337417,"Along with metabolic improvement, omega-3 fatty acids decreased TNF-alpha levels after 12 weeks of treatment (F group × time  = 6.71; df = 1, 66; P = 0.012).","[{'ForeName': 'Feikang', 'Initials': 'F', 'LastName': 'Xu', 'Affiliation': 'Schizophrenia Program, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Weixing', 'Initials': 'W', 'LastName': 'Fan', 'Affiliation': 'Department of Psychiatry, Jinhua Second Hospital, Jinhua, Zhejiang, China.'}, {'ForeName': 'Weiping', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Psychiatry, Jinhua Second Hospital, Jinhua, Zhejiang, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Tang', 'Affiliation': 'Department of Psychiatry, Wenzhou Kangning Hospital, Wenzhou Medical University, Wenzhou, Zhejiang, China.'}, {'ForeName': 'Fuyin', 'Initials': 'F', 'LastName': 'Yang', 'Affiliation': 'Department of Psychiatry, Wenzhou Kangning Hospital, Wenzhou Medical University, Wenzhou, Zhejiang, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Schizophrenia Program, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Cai', 'Affiliation': 'Schizophrenia Program, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Lisheng', 'Initials': 'L', 'LastName': 'Song', 'Affiliation': 'Schizophrenia Program, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Schizophrenia Program, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China. zhangchen645@gmail.com.'}]",Psychopharmacology,['10.1007/s00213-018-5136-9']
725,31074333,Design and analysis of stratified clinical trials in the presence of bias.,"BACKGROUND


Among various design aspects, the choice of randomization procedure have to be agreed on, when planning a clinical trial stratified by center. The aim of the paper is to present a methodological approach to evaluate whether a randomization procedure mitigates the impact of bias on the test decision in clinical trial stratified by center.
METHODS


We use the weighted  t  test to analyze the data from a clinical trial stratified by center with a two-arm parallel group design, an intended 1:1 allocation ratio, aiming to prove a superiority hypothesis with a continuous normal endpoint without interim analysis and no adaptation in the randomization process. The derivation is based on the weighted  t  test under misclassification, i.e. ignoring bias. An additive bias model combing selection bias and time-trend bias is linked to different stratified randomization procedures.
RESULTS


Various aspects to formulate stratified versions of randomization procedures are discussed. A formula for sample size calculation of the weighted  t  test is derived and used to specify the tolerated imbalance allowed by some randomization procedures. The distribution of the weighted  t  test under misclassification is deduced, taking the sequence of patient allocation to treatment, i.e. the randomization sequence into account. An additive bias model combining selection bias and time-trend bias at strata level linked to the applied randomization sequence is proposed. With these before mentioned components, the potential impact of bias on the type one error probability depending on the selected randomization sequence and thus the randomization procedure is formally derived and exemplarily calculated within a numerical evaluation study.
CONCLUSION


The proposed biasing policy and test distribution are necessary to conduct an evaluation of the comparative performance of (stratified) randomization procedure in multi-center clinical trials with a two-arm parallel group design. It enables the choice of the best practice procedure. The evaluation stimulates the discussion about the level of evidence resulting in those kind of clinical trials.",2020,The proposed biasing policy and test distribution are necessary to conduct an evaluation of the comparative performance of (stratified) randomization procedure in multi-center clinical trials with a two-arm parallel group design.,[],[],['tolerated imbalance'],[],[],[],,0.0810538,The proposed biasing policy and test distribution are necessary to conduct an evaluation of the comparative performance of (stratified) randomization procedure in multi-center clinical trials with a two-arm parallel group design.,"[{'ForeName': 'Ralf-Dieter', 'Initials': 'RD', 'LastName': 'Hilgers', 'Affiliation': 'Department of Medical Statistics, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Manolov', 'Affiliation': 'Department of Medical Statistics, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Heussen', 'Affiliation': 'Department of Medical Statistics, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'William F', 'Initials': 'WF', 'LastName': 'Rosenberger', 'Affiliation': 'Department of Statistics, George Mason University, Fairfax, VA, USA.'}]",Statistical methods in medical research,['10.1177/0962280219846146']
726,31735613,"A Comparison Between Hyaluronic Acid and Polylactic Acid Filler Injections for Temporary Penile Augmentation in Patients with Small Penis Syndrome: A Multicenter, Patient/Evaluator-Blind, Comparative, Randomized Trial.","INTRODUCTION


There are only a few studies on the clinical utility of filler injections for penile augmentation (PA) in patients with small penis syndrome (SPS), which is a type of anxiety or body dysmorphic disorder, not a true micropenis.
AIM


To compare the clinical outcomes of hyaluronic acid (HA) with polylactic acid (PLA) filler injection for temporary PA in patients with SPS.
METHODS


Our prospective, patient/evaluator-blind, comparative, randomized, non-inferiority trial consisted of a single filler injection and a 24-week post-injection period. Seventy-four men with SPS were included between November 2017 and February 2018. Patients were divided into those injected with HA (n = 39) and those injected with PLA filler (n = 35).
MAIN OUTCOME MEASURE


The psychological effects of PA, based on the Beliefs about Penis Size Scale, penile girth, and satisfaction, were assessed at baseline and at 4, 12, and 24 weeks post-injection.
RESULTS


At 24 weeks, the mean penile girth increases were 2.1 ± 1.0 cm (P < .001) in the HA group and 1.6 ± 0.9 cm (P < .001) in the PLA group, with a mean difference of 0.5 ± 0.2 cm between groups (P = .031). In both groups, satisfaction levels significantly increased at 24 weeks, with 1.8 ± 1.7 and 1.6 ± 1.4 mean increases in the visual analog scale for penile appearance satisfaction in the HA and PLA groups, respectively (each P < .001), and 1.0 ± 1.1 and 0.7 ± 1.2 mean increases in the visual analog scale for sexual life satisfaction in the HA and PLA groups, respectively (each P < .001), with no significant differences between groups (P = .950 and P = .287). The mean Beliefs about Penis Size Scale scores significantly decreased at 24 weeks, with 7.8 ± 8.3 and 5.3 ± 7.2 mean decreases in the HA and PLA groups, respectively (each P < .001), and no significant difference between the groups (P = .920). There were no serious adverse events, but filler injection-related adverse events in the HA and the PLA groups were reported in 2 cases (5.13%) and 5 cases (14.29%), respectively (P = .245).
CLINICAL IMPLICATIONS


Our study provides an overview of clinical course after HA and PLA filler injections for PA and suggests that filler injections can be considered an alternative approach in patients with SPS.
STRENGTHS & LIMITATIONS


Our study is the first to assess the psychological symptoms in patients with SPS who received the filler injection for PA; however, the follow-up duration was insufficient to prove the long-term outcomes of fillers.
CONCLUSION


Without serious adverse events, HA and PLA filler injections for PA significantly resulted in not only an augmentative effect but also improvement of psychological distress, and the clinical utility was comparable between the fillers. Yang DY, Jeong HC, Ahn ST, et al. A Comparison Between Hyaluronic Acid and Polylactic Acid Filler Injections for Temporary Penile Augmentation in Patients with Small Penis Syndrome: A Multicenter, Patient/Evaluator-Blind, Comparative, Randomized Trial. J Sex Med 2020;17:133-141.",2020,"mean decreases in the HA and PLA groups, respectively (each P < .001), and no significant difference between the groups (P = .920).","['patients with small penis syndrome (SPS', 'patients with SPS', 'Patients with Small Penis Syndrome', 'patients with SPS who received the', 'Seventy-four men with SPS were included between November 2017 and February 2018']","['filler injection for PA', 'Hyaluronic Acid and Polylactic Acid Filler Injections', 'PLA filler', 'hyaluronic acid (HA) with polylactic acid (PLA) filler injection']","['mean penile girth increases', 'Beliefs about Penis Size Scale, penile girth, and satisfaction', 'psychological distress', 'psychological symptoms', 'clinical utility', 'satisfaction levels', 'filler injection-related adverse events', 'visual analog scale for penile appearance satisfaction', 'visual analog scale for sexual life satisfaction', 'serious adverse events', 'mean Beliefs about Penis Size Scale scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0240701', 'cui_str': 'Small penis (finding)'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C4255078', 'cui_str': 'SPS'}, {'cui': 'C4517867', 'cui_str': 'Seventy-four'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0729441', 'cui_str': 'Filler (substance)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C1141990', 'cui_str': 'Hyaluronic acid'}, {'cui': 'C0071443', 'cui_str': 'poly(lactic acid)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0426331', 'cui_str': 'Penis size'}, {'cui': 'C0222045'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0233397', 'cui_str': 'Psychological symptom'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0729441', 'cui_str': 'Filler (substance)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0700364', 'cui_str': 'Appearances (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",74.0,0.0414166,"mean decreases in the HA and PLA groups, respectively (each P < .001), and no significant difference between the groups (P = .920).","[{'ForeName': 'Dae Yul', 'Initials': 'DY', 'LastName': 'Yang', 'Affiliation': 'Department of Urology, College of Medicine, Hallym University, Chuncheon, Korea.'}, {'ForeName': 'Hyun Cheol', 'Initials': 'HC', 'LastName': 'Jeong', 'Affiliation': 'Department of Urology, College of Medicine, Hallym University, Chuncheon, Korea.'}, {'ForeName': 'Sun Tae', 'Initials': 'ST', 'LastName': 'Ahn', 'Affiliation': 'Department of Urology, College of Medicine, Korea University, Seoul, Korea.'}, {'ForeName': 'Woong Jin', 'Initials': 'WJ', 'LastName': 'Bae', 'Affiliation': 'Department of Urology, College of Medicine, Catholic University, Seoul, Korea.'}, {'ForeName': 'Du Geon', 'Initials': 'DG', 'LastName': 'Moon', 'Affiliation': 'Department of Urology, College of Medicine, Korea University, Seoul, Korea.'}, {'ForeName': 'Sae Woong', 'Initials': 'SW', 'LastName': 'Kim', 'Affiliation': 'Department of Urology, College of Medicine, Catholic University, Seoul, Korea.'}, {'ForeName': 'Won Ki', 'Initials': 'WK', 'LastName': 'Lee', 'Affiliation': 'Department of Urology, College of Medicine, Hallym University, Chuncheon, Korea. Electronic address: rheewk@hanmail.net.'}]",The journal of sexual medicine,['10.1016/j.jsxm.2019.10.006']
727,31089955,Self-regulation of language areas using real-time functional MRI in stroke patients with expressive aphasia.,"The objectives of this study were to test (i) If stroke patients with expressive Aphasia could learn to up-regulate the Blood Oxygenation Level Dependent (BOLD) signal in language areas of the brain, namely Inferior Frontal Gyrus (Broca's area) and Superior Temporal Gyrus (Wernicke's area), with real-time fMRI based neurofeedback of the BOLD activation and functional connectivity between the language areas; and (ii) acquired up-regulation could lead to an improvement in expression of language. The study was performed on three groups: Group 1 (n = 4) of Test patients and group 2 (n = 4) of healthy volunteers underwent the neurofeedback training, whereas group 3 (n = 4) of Control patients underwent treatment as usual. Language performance and recovery were assessed using western aphasia battery and picture naming tasks, before and after the neurofeedback training. Results show that the Test group had significant increase in activation of the Broca's area and its right homologue, while the Normal group achieved the greatest activation during neurofeedback. For the Test group both perilesional and contralateral activations were observed. The improvement in language ability of the test patients was not significantly greater than that of the control patients. Neurofeedback training in Aphasia patients induced significant activation of the Broca's area, Wernicke's area and their right homologues, although healthy individuals achieved greater activations in these regions than the patient groups. Training also activated perilesional areas of Rolandic operculum, precentral gyrus and postcentral gyrus for the Test patients significantly. However, lack of behavioral and symptom modifications in the Test group calls for improvements in the efficacy of the approach.",2020,"Training also activated perilesional areas of Rolandic operculum, precentral gyrus and postcentral gyrus for the Test patients significantly.",['stroke patients with expressive aphasia'],"['healthy volunteers underwent the neurofeedback training', 'Neurofeedback training']","['Language performance and recovery', ""activation of the Broca's area and its right homologue"", 'language ability']","[{'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0917814', 'cui_str': 'Aphasia, Expressive'}]","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C2713543', 'cui_str': 'Neurofeedback'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0006208', 'cui_str': ""Broca's Region""}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",,0.0196655,"Training also activated perilesional areas of Rolandic operculum, precentral gyrus and postcentral gyrus for the Test patients significantly.","[{'ForeName': 'Sujesh', 'Initials': 'S', 'LastName': 'Sreedharan', 'Affiliation': 'Medical Device Engineering, Biomedical Technology Wing, SCTIMST, Thiruvananthapuram, India.'}, {'ForeName': 'Anuvitha', 'Initials': 'A', 'LastName': 'Chandran', 'Affiliation': 'Department of Neurology, SCTIMST, Thiruvananthapuram, India.'}, {'ForeName': 'Vijay Raj', 'Initials': 'VR', 'LastName': 'Yanamala', 'Affiliation': 'Medical Device Engineering, Biomedical Technology Wing, SCTIMST, Thiruvananthapuram, India.'}, {'ForeName': 'P N', 'Initials': 'PN', 'LastName': 'Sylaja', 'Affiliation': 'Department of Neurology, SCTIMST, Thiruvananthapuram, India.'}, {'ForeName': 'Chandrasekharan', 'Initials': 'C', 'LastName': 'Kesavadas', 'Affiliation': 'Department of Imaging Sciences and Interventional Radiology, SCTIMST, Thiruvananthapuram, India.'}, {'ForeName': 'Ranganatha', 'Initials': 'R', 'LastName': 'Sitaram', 'Affiliation': 'Institute for Biological and Medical Engineering, Pontificia Universidad Católica de Chile, Santiago, Chile. rasitaram@uc.cl.'}]",Brain imaging and behavior,['10.1007/s11682-019-00106-7']
728,31142465,Defocus Incorporated Multiple Segments (DIMS) spectacle lenses slow myopia progression: a 2-year randomised clinical trial.,"AIM


To determine if 'Defocus Incorporated Multiple Segments' (DIMS) spectacle lenses slow childhood myopia progression.
METHODS


A 2-year double-masked randomised controlled trial was carried out in 183 Chinese children aged 8-13 years, with myopia between -1.00 and -5.00 D and astigmatism ≤1.50 D. Children were randomly assigned to wear DIMS (n=93) or single vision (SV) spectacle lenses (n=90). DIMS lens incorporated multiple segments with myopic defocus of +3.50 D. Refractive error (cycloplegic autorefraction) and axial length were measured at 6month intervals.
RESULTS


160 children completed the study, n=79 in the DIMS group and n=81 in the SV group. Average (SE) myopic progressions over 2 years were -0.41±0.06 D in the DIMS group and -0.85±0.08 D in the SV group. Mean (SE) axial elongation was 0.21±0.02 mm and 0.55±0.02 mm in the DIMS and SV groups, respectively. Myopia progressed 52% more slowly for children in the DIMS group compared with those in the SV group (mean difference -0.44±0.09 D, 95% CI -0.73 to -0.37, p<0.0001). Likewise, children in the DIMS group had less axial elongation by 62% than those in the SV group (mean difference 0.34±0.04 mm, 95% CI 0.22 to 0.37, p<0.0001). 21.5% children who wore DIMS lenses had no myopia progression over 2 years, but only 7.4% for those who wore SV lenses.
CONCLUSIONS


Daily wear of the DIMS lens significantly retarded myopia progression and axial elongation in myopic children. Our results demonstrated simultaneous clear vision with constant myopic defocus can slow myopia progression.
TRIAL REGISTRATION NUMBER


NCT02206217.",2020,"Myopia progressed 52% more slowly for children in the DIMS group compared with those in the SV group (mean difference -0.44±0.09 D, 95% CI -0.73 to -0.37, p<0.0001).","['160 children completed the study, n=79 in the DIMS group and n=81 in the SV group', '183 Chinese children aged 8-13 years, with myopia between -1.00 and -5.00 D and astigmatism ≤1.50 D. Children']","['DIMS lens', 'wear DIMS (n=93) or single vision (SV) spectacle lenses']","['retarded myopia progression and axial elongation', 'Myopia', 'Refractive error (cycloplegic autorefraction) and axial length', 'axial elongation', 'myopia progression', 'Mean (SE) axial elongation']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517615', 'cui_str': 'One hundred and eighty-three'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0027092', 'cui_str': 'Nearsightedness'}, {'cui': 'C0004106', 'cui_str': 'Astigmatism'}]","[{'cui': 'C0023317', 'cui_str': 'Lens, Eye'}, {'cui': 'C1275648', 'cui_str': 'Single vision spectacles'}, {'cui': 'C0023318', 'cui_str': 'Lenses'}]","[{'cui': 'C0521111', 'cui_str': 'Retarded (slowed) (contextual qualifier) (qualifier value)'}, {'cui': 'C0027092', 'cui_str': 'Nearsightedness'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0205131', 'cui_str': 'Axial (qualifier value)'}, {'cui': 'C0034951', 'cui_str': 'Refractive Disorders'}, {'cui': 'C0010586', 'cui_str': 'Cycloplegics'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",183.0,0.432733,"Myopia progressed 52% more slowly for children in the DIMS group compared with those in the SV group (mean difference -0.44±0.09 D, 95% CI -0.73 to -0.37, p<0.0001).","[{'ForeName': 'Carly Siu Yin', 'Initials': 'CSY', 'LastName': 'Lam', 'Affiliation': 'Centre for Myopia Research, School of Optometry, The Hong Kong Polytechnic University, Hung Hom, Hong Kong carly.lam@polyu.edu.hk.'}, {'ForeName': 'Wing Chun', 'Initials': 'WC', 'LastName': 'Tang', 'Affiliation': 'Centre for Myopia Research, School of Optometry, The Hong Kong Polytechnic University, Hung Hom, Hong Kong.'}, {'ForeName': 'Dennis Yan-Yin', 'Initials': 'DY', 'LastName': 'Tse', 'Affiliation': 'Centre for Myopia Research, School of Optometry, The Hong Kong Polytechnic University, Hung Hom, Hong Kong.'}, {'ForeName': 'Roger Pak Kin', 'Initials': 'RPK', 'LastName': 'Lee', 'Affiliation': 'Centre for Myopia Research, School of Optometry, The Hong Kong Polytechnic University, Hung Hom, Hong Kong.'}, {'ForeName': 'Rachel Ka Man', 'Initials': 'RKM', 'LastName': 'Chun', 'Affiliation': 'Centre for Myopia Research, School of Optometry, The Hong Kong Polytechnic University, Hung Hom, Hong Kong.'}, {'ForeName': 'Keigo', 'Initials': 'K', 'LastName': 'Hasegawa', 'Affiliation': 'Hoya Corporation, Tokyo, Japan.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Qi', 'Affiliation': 'Hoya Corporation, Tokyo, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Hatanaka', 'Affiliation': 'Hoya Corporation, Tokyo, Japan.'}, {'ForeName': 'Chi Ho', 'Initials': 'CH', 'LastName': 'To', 'Affiliation': 'Centre for Myopia Research, School of Optometry, The Hong Kong Polytechnic University, Hung Hom, Hong Kong.'}]",The British journal of ophthalmology,['10.1136/bjophthalmol-2018-313739']
729,31594037,Exposure-Response Analyses for Upadacitinib Efficacy and Safety in the Crohn's Disease CELEST Study and Bridging to the Extended-Release Formulation.,"Upadacitinib plasma concentrations, efficacy, and safety data from 216 subjects with moderate-to-severe active Crohn's disease (CD) from the 16-week induction period of the CELEST study were analyzed to characterize upadacitinib exposure-response relationships in CD. Subjects in CELEST received either placebo or upadacitinib (3, 6, 12, 24 mg b.i.d. or 24 mg q.d.). Exposure-response models were developed and utilized to simulate efficacy of induction doses of the immediate-release (IR) and extended-release (ER) formulations. Upadacitinib exposures associated with 18-24 mg b.i.d. (IR formulation) or 45-60 mg q.d. (ER formulation) are estimated to have greater efficacy during 12-week induction in patients with CD compared with lower doses. No exposure-response relations were observed with decreases in hemoglobin or lymphocytes at week 16 or with herpes zoster infections, pneumonia, or serious infections during 16 weeks of treatment in this study. These analyses informed the selection of upadacitinib induction dose for phase III studies in CD.",2020,"No exposure-response relations were observed with decreases in hemoglobin or lymphocytes at Week 16 or with herpes zoster infections, pneumonia, or serious infections during 16 weeks of treatment in this study.","[""216 subjects with moderately-to-severely active Crohn's disease (CD""]",['placebo or upadacitinib'],"['Upadacitinib plasma concentrations, efficacy, and safety data', 'hemoglobin or lymphocytes']","[{'cui': 'C4708905', 'cui_str': 'Two hundred and sixteen'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0156147', 'cui_str': 'Colitis, Granulomatous'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4018897', 'cui_str': 'Lymphocyte component of blood'}]",216.0,0.019054,"No exposure-response relations were observed with decreases in hemoglobin or lymphocytes at Week 16 or with herpes zoster infections, pneumonia, or serious infections during 16 weeks of treatment in this study.","[{'ForeName': 'Mohamed-Eslam F', 'Initials': 'MF', 'LastName': 'Mohamed', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics, AbbVie Inc., North Chicago, Illinois, USA.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Klünder', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics, AbbVie Inc., North Chicago, Illinois, USA.'}, {'ForeName': 'Ana P', 'Initials': 'AP', 'LastName': 'Lacerda', 'Affiliation': 'Immunology Development, AbbVie Inc., North Chicago, Illinois, USA.'}, {'ForeName': 'Ahmed A', 'Initials': 'AA', 'LastName': 'Othman', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics, AbbVie Inc., North Chicago, Illinois, USA.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.1668']
730,31102881,Examining the role of a brief online alcohol use risk feedback on accessing information about available treatment resources for alcohol issues.,"Research suggests college-aged young adults are hesitant to seek treatment for alcohol use disorder and highlights barriers contributing to a gap in treatment utilization. One barrier to treatment utilization is the lack of information about available treatment resources. Motivated by the literature on web-based screening and brief interventions (eSBIs), the current study examined whether providing a brief online feedback of one's alcohol use risk severity will make college students more likely to access information about available treatment options for alcohol-related issues. College students (N = 724) who responded to the Alcohol Use Disorder Identification Test (Babor, Higgins-Biddle, Saunders, & Monteiro, 2001) were randomly assigned to receive a brief online feedback on their alcohol use risk or to a no-feedback condition. Overall, only 20% of all participants opted to view available treatment services for alcohol issues. Participants in the feedback group (15%) were significantly less likely to view information for available services compared to the no-feedback group (24%). A significant feedback condition x stigma interaction effect was found, such that those with average and high stigma towards substance use scores were less likely to view treatment information when provided feedback. Without a thorough discussion of individual risks and without the safeguards against psychological reactance present in eSBIs, providing college students with brief online feedback about their alcohol use risk severity made them less likely to access information concerning available on-campus mental health resources for alcohol issues. On the other hand, improving help-seeking attitudes could help increase treatment utilization.",2019,Participants in the feedback group (15%) were significantly less likely to view information for available services compared to the no-feedback group (24%).,"['college-aged young adults', 'College students (N\u202f=\u202f724) who responded to the Alcohol Use Disorder Identification Test (Babor, Higgins-Biddle, Saunders, & Monteiro, 2001', 'college students']",['brief online feedback on their alcohol use risk or to a no-feedback condition'],['feedback condition x stigma interaction effect'],"[{'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test (assessment scale)'}]","[{'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0277787', 'cui_str': 'Stigma (finding)'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",,0.0117714,Participants in the feedback group (15%) were significantly less likely to view information for available services compared to the no-feedback group (24%).,"[{'ForeName': 'Antover P', 'Initials': 'AP', 'LastName': 'Tuliao', 'Affiliation': 'Community, Family, and Addiction Sciences Department, Texas Tech University, United States of America. Electronic address: Antover.tuliao@ttu.edu.'}, {'ForeName': 'Natira D', 'Initials': 'ND', 'LastName': 'Mullet', 'Affiliation': 'Community, Family, and Addiction Sciences Department, Texas Tech University, United States of America.'}, {'ForeName': 'Lindsey G', 'Initials': 'LG', 'LastName': 'Hawkins', 'Affiliation': 'Community, Family, and Addiction Sciences Department, Texas Tech University, United States of America.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Holyoak', 'Affiliation': 'Community, Family, and Addiction Sciences Department, Texas Tech University, United States of America.'}, {'ForeName': 'Marisa', 'Initials': 'M', 'LastName': 'Weerts', 'Affiliation': 'Community, Family, and Addiction Sciences Department, Texas Tech University, United States of America.'}, {'ForeName': 'Travis', 'Initials': 'T', 'LastName': 'Gudenrath', 'Affiliation': 'Community, Family, and Addiction Sciences Department, Texas Tech University, United States of America.'}]",Addictive behaviors,['10.1016/j.addbeh.2019.05.004']
731,31757717,Central venous access device Securement and dressing effectiveness: The CASCADE pilot randomised controlled trial in the adult intensive care.,"INTRODUCTION


Central venous access devices (CVADs) are a vital medical device for intensive care (ICU) patients; however, complications and failure are common, yet potentially prevented through effective dressings and securement.
OBJECTIVES/AIMS


The objective of this study was to test the feasibility of a randomised controlled trial (RCT) comparing standard care with three dressing and securement products to prevent CVAD failure. Secondary aims included comparing dressing and securement products on CVAD failure, microbial colonisation, and intervention costs.
METHODS


A single-centre pilot RCT of ICU adult patients requiring CVADs for >24 h were randomised to four groups: (i) sutures plus chlorhexidine gluconate (CHG) dressing (standard care); (ii) standard care plus tissue adhesive (TA); (iii) two sutureless stabilisation devices (SSD) plus CHG dressing; (iv) sutures, CHG disc plus integrated securement dressing (ISD). Descriptive statistics assessed feasibility. Incidence rates (IRs) of CVAD failure were reported, with group differences compared using the Fisher exact and log-rank tests. Cox regression explored univariable risks for failure. A substudy examined bacterial colonisation of catheter tips, dressings, and skin. Cost estimates of the intervention were compared.
RESULTS


A total of 121 participants were randomised. Study feasibility was established with no withdrawal and moderate staff acceptability; however, recruitment was low at 12%. Overall CVAD failure was seen in 14 of 114 (12%) CVADs (19 per 1000 catheter-days); highest in the SSD group (IR: 27.3 per 1000 catheter-days [95% confidence interval {CI}: 11.4-65.6]), followed by the standard care group (IR: 22.3 per 1000 catheter-days [95% CI: 8.38-59.5]) and TA group (IR: 20.6 per 1000 catheter-days [95% CI: 6.66-64.0]), and lowest in the ISD group (IR: 8.8 per 1000 catheter-days [95% CI: 2.19-35.0]). The majority of complications (11/14, 79%) were suspected central line-associated bloodstream infection (CLABSI), of which only one was laboratory confirmed (standard care group). The cost per patient was lowest in the standard care group by an average difference of AUD $14.
CONCLUSION(S)


A large multisite RCT examining forms of securement and dressing is feasible. ISD is the highest priority to test further as it had the lowest failure rate.
TRIAL REGISTRATION


ACTRN12615000667516 PROTOCOL: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id = 368765.",2020,"Overall CVAD failure was seen in 14 of 114 (12%) CVADs (19 per 1000 catheter-days); highest in the SSD group (IR: 27.3 per 1000 catheter-days [95% confidence interval {CI}: 11.4-65.6]), followed by the standard care group (IR: 22.3 per 1000 catheter-days [95% CI: 8.38-59.5]) and TA group (IR: 20.6 per 1000 catheter-days","['ICU adult patients requiring CVADs for >24\xa0h', 'adult intensive care', 'A total of 121 participants were randomised']","['sutures plus chlorhexidine gluconate (CHG) dressing (standard care); (ii) standard care plus tissue adhesive (TA); (iii) two sutureless stabilisation devices (SSD) plus CHG dressing; (iv) sutures, CHG disc plus integrated securement dressing (ISD', 'Central venous access devices (CVADs']","['Incidence rates (IRs) of CVAD failure', 'Overall CVAD failure', 'dressing effectiveness', 'CVAD failure, microbial colonisation, and intervention costs', 'suspected central line-associated bloodstream infection (CLABSI']","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085559'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0055361', 'cui_str': 'chlorhexidine gluconate'}, {'cui': 'C0013119', 'cui_str': 'Dressings'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0040277', 'cui_str': 'Tissue Adhesives'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C1527601', 'cui_str': '(alphaMe)Chg'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C1705370', 'cui_str': 'Disc - unit of product usage'}, {'cui': 'C0444466', 'cui_str': 'Central venous (qualifier value)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C4321376', 'cui_str': 'Dressing'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C1145640', 'cui_str': 'Central Venous Catheters'}, {'cui': 'C2316160', 'cui_str': 'Infection of bloodstream'}]",121.0,0.160609,"Overall CVAD failure was seen in 14 of 114 (12%) CVADs (19 per 1000 catheter-days); highest in the SSD group (IR: 27.3 per 1000 catheter-days [95% confidence interval {CI}: 11.4-65.6]), followed by the standard care group (IR: 22.3 per 1000 catheter-days [95% CI: 8.38-59.5]) and TA group (IR: 20.6 per 1000 catheter-days","[{'ForeName': 'Marion L', 'Initials': 'ML', 'LastName': 'Mitchell', 'Affiliation': 'Alliance for Vascular Access Teaching and Research Group (AVATAR), Menzies Health Institute Queensland, Griffith University, Australia; School of Nursing and Midwifery, Griffith University, Brisbane, Queensland, Australia; Intensive Care Unit, Princess Alexandra Hospital, Brisbane, Queensland, Australia. Electronic address: marion.mitchell@griffith.edu.au.'}, {'ForeName': 'Amanda J', 'Initials': 'AJ', 'LastName': 'Ullman', 'Affiliation': 'Alliance for Vascular Access Teaching and Research Group (AVATAR), Menzies Health Institute Queensland, Griffith University, Australia; School of Nursing and Midwifery, Griffith University, Brisbane, Queensland, Australia.'}, {'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Takashima', 'Affiliation': 'Alliance for Vascular Access Teaching and Research Group (AVATAR), Menzies Health Institute Queensland, Griffith University, Australia; School of Nursing and Midwifery, Griffith University, Brisbane, Queensland, Australia.'}, {'ForeName': 'Chelsea', 'Initials': 'C', 'LastName': 'Davis', 'Affiliation': 'Intensive Care Unit, Princess Alexandra Hospital, Brisbane, Queensland, Australia.'}, {'ForeName': 'Gabor', 'Initials': 'G', 'LastName': 'Mihala', 'Affiliation': 'Alliance for Vascular Access Teaching and Research Group (AVATAR), Menzies Health Institute Queensland, Griffith University, Australia; Centre for Applied Health Economics, Menzies Health Institute Queensland, Griffith University, Nathan, Queensland, Australia; School of Medicine, Griffith University, Nathan, Queensland, Australia.'}, {'ForeName': 'Madeleine', 'Initials': 'M', 'LastName': 'Powell', 'Affiliation': 'Intensive Care Unit, Princess Alexandra Hospital, Brisbane, Queensland, Australia.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Gibson', 'Affiliation': 'Alliance for Vascular Access Teaching and Research Group (AVATAR), Menzies Health Institute Queensland, Griffith University, Australia.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Alliance for Vascular Access Teaching and Research Group (AVATAR), Menzies Health Institute Queensland, Griffith University, Australia.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Bauer', 'Affiliation': 'University of Queensland Centre for Clinical Research, Herston, Queensland, Australia.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Geoffrey Playford', 'Affiliation': 'Alliance for Vascular Access Teaching and Research Group (AVATAR), Menzies Health Institute Queensland, Griffith University, Australia; Infection Management Services, Princess Alexandra Hospital, Brisbane, Queensland, Australia.'}, {'ForeName': 'Claire M', 'Initials': 'CM', 'LastName': 'Rickard', 'Affiliation': 'Alliance for Vascular Access Teaching and Research Group (AVATAR), Menzies Health Institute Queensland, Griffith University, Australia; School of Nursing and Midwifery, Griffith University, Brisbane, Queensland, Australia; Visiting Scholar, Nursing Professional Development Unit, Princess Alexandra Hospital, Brisbane, Queensland, Australia.'}]",Australian critical care : official journal of the Confederation of Australian Critical Care Nurses,['10.1016/j.aucc.2019.10.002']
732,30527256,Dietary intervention with an Okinawan-based Nordic diet in type 2 diabetes renders decreased interleukin-18 concentrations and increased neurofilament light concentrations in plasma.,"Food may induce inflammation and favor development of metabolic diseases, which have been associated with increased inflammation and potential risk of cognitive impairment. It is customary to know whether food or disease promote inflammation. Our hypothesis was that Okinawan-based Nordic (O-BN) diet leads to decreased circulating concentrations of inflammatory and neural biomarkers. The objectives of this study were to examine the effects of the O-BN diet on inflammatory and neural responses. First, 2 different breakfasts; one standard and another O-BN-based, were given in random order to 19 healthy volunteers. Second, a 12-week O-BN-dietary intervention was performed in type 2 diabetes mellitus (T2DM), where the participants were followed for another 16-weeks, with registration of anthropometry and metabolic parameters. Non-diabetic subjects served as controls at baseline. Plasma was analyzed for cytokines by a 10-plex Luminex assay and neurofilament light (NfL) by an ultrasensitive Single molecule assay. Cytokine levels decreased after a single breakfast intake, independent of diet composition. Cytokine levels were higher in T2DM than in controls. Anthropometric and metabolic parameters were improved by the dietary intervention. In parallel, cytokine levels were lowered, although only significantly for IL-18 (P = .001), with a tendency of significance for IL-12p70 (P = .07). Levels of IL-18 correlated with glucose, HbA1c and lipids, but not with body mass index, insulin or blood pressure. NfL levels increased during the intervention (P = .049). O-BN-based diet does not affect postprandial cytokine levels in health, whereas it renders decreased circulating IL-18 levels along with metabolic biomarkers in T2DM, with no beneficial effect on NfL.",2018,"Levels of IL-18 correlated with glucose, HbA1c and lipids, but not with body mass index, insulin or blood pressure.",['19 healthy volunteers'],"['O-BN diet', 'Dietary intervention with an Okinawan-based Nordic diet']","['NfL levels', 'inflammatory and neural responses', 'Anthropometric and metabolic parameters', 'IL-18', 'Levels of IL-18 correlated with glucose, HbA1c and lipids, but not with body mass index, insulin or blood pressure', 'circulating IL-18 levels', 'cytokine levels', 'circulating concentrations of inflammatory and neural biomarkers', 'Cytokine levels', 'postprandial cytokine levels']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0383327', 'cui_str': 'Interferon-gamma-Inducing Factor'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}]",19.0,0.0256183,"Levels of IL-18 correlated with glucose, HbA1c and lipids, but not with body mass index, insulin or blood pressure.","[{'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Nilholm', 'Affiliation': 'Lund University, Skane University Hospital, Department of Internal Medicine, Malmö, Sweden.'}, {'ForeName': 'Bodil', 'Initials': 'B', 'LastName': 'Roth', 'Affiliation': 'Lund University, Skane University Hospital, Department of Internal Medicine, Malmö, Sweden.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Höglund', 'Affiliation': 'Lund University, Skane University Hospital, Department of Clinical Chemistry & Pharmacology, Lund, Sweden.'}, {'ForeName': 'Kaj', 'Initials': 'K', 'LastName': 'Blennow', 'Affiliation': 'Department of Psychiatry and Neurochemistry, Institute of Neuroscience and Physiology, the Sahlgrenska Academy at the University of Gothenburg, Mölndal, Sweden; Clinical Neurochemistry Laboratory, Sahlgrenska University Hospital, Mölndal, Sweden.'}, {'ForeName': 'Elisabet', 'Initials': 'E', 'LastName': 'Englund', 'Affiliation': 'Lund University, Department of Oncology and Pathology, Lund, Sweden.'}, {'ForeName': 'Oskar', 'Initials': 'O', 'LastName': 'Hansson', 'Affiliation': 'Clinical Memory Research Unit, Department of Clinical Sciences Malmö, Lund University, Sweden; Memory Clinic, Skåne University Hospital, Malmö, Sweden.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Zetterberg', 'Affiliation': 'Department of Psychiatry and Neurochemistry, Institute of Neuroscience and Physiology, the Sahlgrenska Academy at the University of Gothenburg, Mölndal, Sweden; Clinical Neurochemistry Laboratory, Sahlgrenska University Hospital, Mölndal, Sweden; Department of Molecular Neuroscience, UCL Institute of Neurology, Queen Square, London, UK; UK Dementia Research Institute at UCL, London, UK.'}, {'ForeName': 'Bodil', 'Initials': 'B', 'LastName': 'Ohlsson', 'Affiliation': 'Lund University, Skane University Hospital, Department of Internal Medicine, Malmö, Sweden. Electronic address: bodil.ohlsson@med.lu.se.'}]","Nutrition research (New York, N.Y.)",['10.1016/j.nutres.2018.08.002']
733,30254071,Methylation-derived Neutrophil-to-Lymphocyte Ratio and Lung Cancer Risk in Heavy Smokers.,"The neutrophil-to-lymphocyte ratio (NLR) is a biomarker that indicates systemic inflammation and can be estimated using array-based DNA methylation data as methylation-derived NLR (mdNLR). We assessed the relationship between prediagnosis mdNLR and lung cancer risk in a nested case-control study in the β-Carotene and Retinol Efficacy Trial (CARET) of individuals at high risk for lung cancer due to heavy smoking or substantial occupational asbestos exposure. We matched 319 incident lung cancer cases to controls based on age at blood draw, smoking, sex, race, asbestos, enrollment year, and time at risk. We computed mdNLR using the ratio of predicted granulocyte and lymphocyte proportions derived from DNA methylation signatures in whole blood collected prior to diagnosis (median 4.4 years in cases). Mean mdNLR was higher in cases than controls (2.06 vs. 1.86,  P  = 0.03). Conditional logistic regression models adjusted for potential confounders revealed a 21% increased risk of lung cancer per unit increase in mdNLR [OR 1.21; 95% confidence interval (CI) 1.01-1.45]. A 30% increased risk of non-small cell lung cancer (NSCLC) was observed for each unit increase in mdNLR ( n  = 240 pairs; OR 1.30, 95% CI, 1.03-1.63), and there was no statistically significant association between mdNLR and small-cell lung cancer risk. The mdNLR-NSCLC association was most pronounced in those with asbestos exposure ( n  = 42 male pairs; OR 3.39; 95% CI, 1.32-8.67). A better understanding of the role of mdNLR in lung cancer etiology may improve prevention and detection of lung cancer.  Cancer Prev Res; 11(11); 727-34. ©2018 AACR .",2018,"Mean mdNLR was higher in cases than controls (2.06 vs. 1.86,  P  = 0.03).","['Heavy Smokers', 'individuals at high risk for lung cancer due to heavy smoking or substantial occupational asbestos exposure', '319 incident lung cancer cases to controls based on age at blood draw, smoking, sex, race, asbestos, enrollment year, and time at risk']",[],"['risk of non-small cell lung cancer (NSCLC', 'mdNLR and small-cell lung cancer risk', 'neutrophil-to-lymphocyte ratio (NLR', 'Methylation-derived Neutrophil-to-Lymphocyte Ratio and Lung Cancer Risk', 'risk of lung cancer', 'mdNLR-NSCLC association', 'Mean mdNLR']","[{'cui': 'C0857118', 'cui_str': 'Heavy smoker'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0521127', 'cui_str': 'Occupational (qualifier value)'}, {'cui': 'C0003948', 'cui_str': 'Exposure to asbestos (event)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0190979', 'cui_str': 'Venesection'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0003949', 'cui_str': 'Asbestosis'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1444641', 'cui_str': 'At risk'}]",[],"[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0149925', 'cui_str': 'Oat Cell Lung Cancer'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C4018897', 'cui_str': 'Lymphocyte component of blood'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0025723', 'cui_str': 'Methylation'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",42.0,0.0271279,"Mean mdNLR was higher in cases than controls (2.06 vs. 1.86,  P  = 0.03).","[{'ForeName': 'Laurie', 'Initials': 'L', 'LastName': 'Grieshober', 'Affiliation': 'Department of Population Health Sciences, Huntsman Cancer Institute, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Graw', 'Affiliation': 'Department of Biostatistics, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Matt J', 'Initials': 'MJ', 'LastName': 'Barnett', 'Affiliation': 'Program in Epidemiology, Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'Thornquist', 'Affiliation': 'Program in Epidemiology, Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Gary E', 'Initials': 'GE', 'LastName': 'Goodman', 'Affiliation': 'Program in Epidemiology, Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Chu', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Program in Epidemiology, Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Devin C', 'Initials': 'DC', 'LastName': 'Koestler', 'Affiliation': 'Department of Biostatistics, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Carmen J', 'Initials': 'CJ', 'LastName': 'Marsit', 'Affiliation': 'Department of Environmental Health, Rollins School of Public Health, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Doherty', 'Affiliation': 'Department of Population Health Sciences, Huntsman Cancer Institute, University of Utah, Salt Lake City, Utah. jen.doherty@hci.utah.edu.'}]","Cancer prevention research (Philadelphia, Pa.)",['10.1158/1940-6207.CAPR-18-0111']
734,31102326,"Efficacy and safety of dulaglutide monotherapy compared with glimepiride in Chinese patients with type 2 diabetes: Post-hoc analyses of a randomized, double-blind, phase III study.","AIMS/INTRODUCTION


To investigate the efficacy/safety of dulaglutide once-weekly monotherapy versus glimepiride in Chinese patients with type 2 diabetes.
MATERIALS AND METHODS


This was a post-hoc analysis of a Chinese randomized, double-blind, non-inferiority, phase III study. Patients (n = 572) with inadequate glycemic control received dulaglutide 1.5 mg (n = 189) or 0.75 mg (n = 194) once-weekly or glimepiride (1-3 mg/day; n = 189) for 26 weeks. The primary objective of the study was to investigate the non-inferiority of dulaglutide 1.5 mg versus glimepiride by the change from baseline to week 26 in glycated hemoglobin (non-inferiority margin 0.4%).
RESULTS


Dulaglutide 1.5 mg and 0.75 mg were non-inferior (P < 0.001) and superior (P ≤ 0.002) versus glimepiride for the change in glycated hemoglobin from baseline to week 26. The least-squares mean differences (95% confidence interval) versus glimepiride were dulaglutide 1.5 mg, -0.53% (-0.74, -0.32) and dulaglutide 0.75 mg, -0.32% (-0.53, -0.12). Significantly more patients attained glycated hemoglobin <7.0% at week 26 in the dulaglutide 1.5 mg (71.7%) versus the glimepiride (57.5%; P = 0.005) group. The decrease from baseline to week 26 in fasting blood glucose was significantly more pronounced in both the dulaglutide groups versus the glimepiride group (P < 0.01). The overall incidence and rate of hypoglycemia were lower in both of the dulaglutide groups versus the glimepiride group. At week 26, bodyweight had increased from baseline in the glimepiride group and decreased from baseline in both dulaglutide groups. The most frequent gastrointestinal drug-related adverse events with dulaglutide were diarrhea, abdominal distension, nausea and vomiting.
CONCLUSIONS


These findings support once-weekly dulaglutide monotherapy as a treatment for Chinese patients with early stage type 2 diabetes.",2020,The decrease from baseline to week 26 in fasting blood glucose was significantly more pronounced in both the dulaglutide groups versus the glimepiride group (P < 0.01).,"['Chinese patients with early stage type\xa02 diabetes', 'Patients (n\xa0=\xa0572) with inadequate glycemic control received', 'Chinese patients with type\xa02 diabetes']","['dulaglutide monotherapy', 'glimepiride', 'dulaglutide 1.5\xa0mg (n\xa0=\xa0189) or 0.75\xa0mg (n\xa0=\xa0194) once-weekly or glimepiride', 'dulaglutide 1.5\xa0mg versus glimepiride', 'dulaglutide once-weekly monotherapy versus glimepiride']","['diarrhea, abdominal distension, nausea and vomiting', 'glycated hemoglobin', 'fasting blood glucose', 'Efficacy and safety', 'efficacy/safety', 'overall incidence and rate of hypoglycemia']","[{'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0205412', 'cui_str': 'Inadequate (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C3179549', 'cui_str': 'dulaglutide'}, {'cui': 'C0061323', 'cui_str': 'glimepiride'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C4068882', 'cui_str': '0.75'}, {'cui': 'C0558293', 'cui_str': 'Once a week (qualifier value)'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0000731', 'cui_str': 'Swollen abdomen (finding)'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C0017853', 'cui_str': 'Hemoglobin, Glycosylated'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}]",572.0,0.0981956,The decrease from baseline to week 26 in fasting blood glucose was significantly more pronounced in both the dulaglutide groups versus the glimepiride group (P < 0.01).,"[{'ForeName': 'Li Xin', 'Initials': 'LX', 'LastName': 'Shi', 'Affiliation': 'Department of Endocrinology and Metabolism, Affiliated Hospital of Guizhou Medical University, Guiyang, China.'}, {'ForeName': 'Xiao Min', 'Initials': 'XM', 'LastName': 'Liu', 'Affiliation': 'Department of Endocrinology, First Affiliated Hospital of Harbin Medical University, Harbin, China.'}, {'ForeName': 'Yong Quan', 'Initials': 'YQ', 'LastName': 'Shi', 'Affiliation': 'Shanghai Changzheng Hospital, Shanghai, China.'}, {'ForeName': 'Quan Min', 'Initials': 'QM', 'LastName': 'Li', 'Affiliation': 'Beijing 262 Hospital, Beijing, China.'}, {'ForeName': 'Jian Hua', 'Initials': 'JH', 'LastName': 'Ma', 'Affiliation': 'Nanjing First Hospital, Nanjing, China.'}, {'ForeName': 'Yan Bing', 'Initials': 'YB', 'LastName': 'Li', 'Affiliation': 'The First Affiliated Hospital, Sun-Yat Sen University, Guangzhou, China.'}, {'ForeName': 'Li Ying', 'Initials': 'LY', 'LastName': 'Du', 'Affiliation': 'Lilly Suzhou Pharmaceutical Co. Ltd., Shanghai, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': 'Lilly Suzhou Pharmaceutical Co. Ltd., Shanghai, China.'}, {'ForeName': 'Lu Lu', 'Initials': 'LL', 'LastName': 'Chen', 'Affiliation': 'Department of Endocrinology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}]",Journal of diabetes investigation,['10.1111/jdi.13075']
735,31035080,Shifts in momentary motivation to quit smoking based on experimental context and perceptions of motivational instability.,"BACKGROUND


Smoking quit intentions (i.e., plans or commitments to reduce smoking) are distinct from quit motivation (i.e., desire to quit). Motivation to quit is a dynamic avoidance motivational state, likely subject to frequent fluctuations and shifts based on environmental context, similar to craving (an approach motivational state). Moreover, people's perceptions of motivational instability may influence their momentary quit motivation and beliefs surrounding their abilities to manage the quit process successfully.
METHODS


In the current study, smokers were recruited online. Baseline motivation to quit was examined along with perceptions of motivational instability. Participants who reported some interest in eventually quitting (n = 174; M age  = 45.29, SD = 14.81, 74.1% women) were randomly assigned to negative affect, cigarette or neutral cue conditions and then momentary motivation to quit was assessed, followed by a validated index of quit intentions.
RESULTS


Participants in the negative affect and cigarette cue conditions reported greater momentary motivation to quit than participants in the neutral condition (F = 3.73, p = .03), particularly for people who reported upfront that their motivation did not change from day-to-day (F = 3.97, p = .02). In addition, greater momentary quit motivation predicted stronger quit intentions (B = 0.66, p < .001).
CONCLUSION


Findings from this study suggest that motivation to quit is likely dynamic and influenced by context as well as by self-perceptions. Implications suggest that further efforts to separate motivation from intention may be useful in understanding smokers' desires and plans to quit smoking.",2019,"RESULTS


Participants in the negative affect and cigarette cue conditions reported greater momentary motivation to quit than participants in the neutral condition (F = 3.73, p = .03), particularly for people who reported upfront that their motivation did not change from day-to-day (F = 3.97, p = .02).","['Participants who reported some interest in eventually quitting (n\u202f=\u202f174; M age \u202f=\u202f45.29, SD\u202f=\u202f14.81, 74.1% women']",[],"['momentary motivation to quit', 'momentary quit motivation predicted stronger quit intentions']","[{'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C4517604', 'cui_str': 'One hundred and seventy-four'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]",[],"[{'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0442821', 'cui_str': 'Strong (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}]",,0.0703865,"RESULTS


Participants in the negative affect and cigarette cue conditions reported greater momentary motivation to quit than participants in the neutral condition (F = 3.73, p = .03), particularly for people who reported upfront that their motivation did not change from day-to-day (F = 3.97, p = .02).","[{'ForeName': 'Jennifer C', 'Initials': 'JC', 'LastName': 'Veilleux', 'Affiliation': 'Department of Psychological Science, University of Arkansas, 216 Memorial Hall, Fayetteville, AR 72701, United States. Electronic address: jcveille@uark.edu.'}]",Addictive behaviors,['10.1016/j.addbeh.2019.04.012']
736,30880522,The effect of patient-selected or preselected music on anxiety during cesarean delivery: a randomized controlled trial.,"Background:  Women undergoing cesarean delivery may have significant anxiety prior to surgery. Nonpharmacological approaches to anxiety reduction are favored in this patient population. Objective:  The aim of this study was to determine the effects of patient-selected or preselected music on anxiety in parturients undergoing scheduled cesarean delivery. Materials and methods:  This is a prospective, randomized controlled trial (IRB protocol #2015P002043; ClinicalTrials.gov, NCT02732964), of 150 parturients undergoing elective cesarean delivery. Parturients were randomized to patient-selected music (Pandora ® ), preselected music (Mozart), or no music (control). The primary outcome was anxiety after music exposure (versus no music) in the preoperative holding room. Secondary outcomes included postoperative anxiety, postoperative pain, and patient satisfaction. Results:  Baseline anxiety and anxiety following preoperative exposure did not differ in the Pandora versus control group (3.8 ± 2.4 versus 4.6 ± 2.6, mean difference -0.8 [95% CI -1.8 to 0.2],  p  = .12), but was lower in the Mozart group versus control group (3.5 ± 2.5 versus 4.6 ± 2.5, mean difference -1.1 [95% CI -2.2 to -0.1],  p  = .03). Postoperative anxiety did not differ in the Pandora versus control group (1.0 ± 1.4 versus 1.3 ± 2.0, mean difference -0.3 [95% CI -1.0 to 0.4],  p  = .43), or in the Mozart versus control group (0.8 ± 1.3 versus 1.3 ± 2.0, mean difference -0.5 [95% CI -1.2 to 0.2],  p  = .15). Postoperative pain was not different in the Pandora group versus control group (0.8 ± 1.5 versus 1.4 ± 1.9, mean difference -0.6 [95% CI -1.3 to 0.1],  p  = .10), but was lower in the Mozart versus control group (0.6 ± 1.3 versus 1.4 ± 1.9, mean difference -0.8 [95% CI -1.4 to -0.1],  p  = .03). Total patient satisfaction scores were not different among the control, Pandora, and Mozart groups. Conclusion:  While preselected Mozart music results in lower anxiety prior to cesarean delivery, patient-selected Pandora music does not. Further investigation to determine how music affects patients, clinicians, and the operating room environment during cesarean delivery is warranted. Clinical trial registration:  NCT02732964.",2020,"Postoperative pain was not different in the Pandora group versus control group (0.8 ± 1.5 versus 1.4 ± 1.9, mean difference -0.6","['patient-selected or preselected music on anxiety during cesarean delivery', '150 parturients undergoing elective cesarean delivery', 'parturients undergoing scheduled cesarean delivery']","['patient-selected music (Pandora ® ), preselected music (Mozart), or no music (control', 'patient-selected or preselected music']","['Baseline anxiety and anxiety', 'Postoperative pain', 'anxiety after music exposure (versus no music', 'Postoperative anxiety', 'Total patient satisfaction scores', 'postoperative anxiety, postoperative pain, and patient satisfaction']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1384674', 'cui_str': 'Deliveries by cesarean (finding)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0451370', 'cui_str': 'Patient satisfaction score (assessment scale)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}]",150.0,0.271018,"Postoperative pain was not different in the Pandora group versus control group (0.8 ± 1.5 versus 1.4 ± 1.9, mean difference -0.6","[{'ForeName': 'Dan Michael', 'Initials': 'DM', 'LastName': 'Drzymalski', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, Tufts Medical Center, Tufts University School of Medicine, Boston, MA, USA.'}, {'ForeName': 'Mario Isaac', 'Initials': 'MI', 'LastName': 'Lumbreras-Marquez', 'Affiliation': ""Department of Anesthesiology, Perioperative, and Pain Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Lawrence Ching', 'Initials': 'LC', 'LastName': 'Tsen', 'Affiliation': ""Department of Anesthesiology, Perioperative, and Pain Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'William Reid', 'Initials': 'WR', 'LastName': 'Camann', 'Affiliation': ""Department of Anesthesiology, Perioperative, and Pain Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Michaela Kristina', 'Initials': 'MK', 'LastName': 'Farber', 'Affiliation': ""Department of Anesthesiology, Perioperative, and Pain Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}]","The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians",['10.1080/14767058.2019.1594766']
737,31749238,"A 12-week, randomized, double-blind, placebo-controlled, four-arm dose-finding phase 2 study evaluating bexagliflozin as monotherapy for adults with type 2 diabetes.","AIM


To compare the safety and efficacy of bexagliflozin administered as monotherapy at three dosage strengths over a 12-week period to patients with type 2 diabetes who were either naïve to pharmacotherapy or were previously prescribed one oral hypoglycaemic agent and underwent a 6-week period of medication abstinence.
METHODS


Adults with type 2 diabetes (n = 292) having an HbA1c of between 7.0% and 8.5% were randomized to receive one of three dosage strengths of bexagliflozin (5, 10 or 20 mg) or placebo. The primary endpoint was the change from baseline to week 12 in the %HbA1c. Secondary endpoints included the changes from baseline in fasting plasma glucose (FPG), systolic blood pressure and diastolic blood pressure, body mass and fraction of patients achieving an HbA1c of <7%.
RESULTS


The mixed model repeated measure estimates of the placebo-adjusted change in %HbA1c from baseline to week 12 for the 5, 10 and 20 mg groups were -0.55% (95% CI: -0.76%, -0.34%, P < 0.0001), -0.68% (95% CI: -0.89%, -0.47%, P < 0.0001) and -0.80% (95% CI: -1.01%, -0.59%, P < 0.0001), respectively. Significant and dose-dependent placebo-adjusted mean reductions from baseline to week 12 in FPG and body mass were observed. The fraction of subjects achieving an HbA1c of <7% was significantly greater in the 20 mg bexagliflozin group. The incidence of adverse events was similar for participants in all active arms (42.3%) compared with the rate measured in those receiving placebo (40.3%).
CONCLUSIONS


Bexagliflozin confers substantial and dose-dependent benefits on subjects with type 2 diabetes and has an acceptable safety profile. Further evaluation of bexagliflozin for the control of type 2 diabetes in adults is warranted.",2020,Significant and dose-dependent placebo-adjusted mean reductions from baseline to week 12 in FPG and body mass were observed.,"['subjects with type 2 diabetes', 'patients with type 2 diabetes who were either naïve to pharmacotherapy or were previously prescribed one oral hypoglycemic agent and underwent a six-week period of medication abstinence', 'Adults with Type 2 Diabetes', 'Adults with type 2 diabetes (n\xa0=\xa0292) having an HbA 1c  between 7.0% and 8.5']","['placebo', 'Placebo', 'Bexagliflozin', 'bexagliflozin']","['fasting plasma glucose (FPG), systolic and diastolic blood pressure (SBP and DBP), body mass and fraction of patients achieving HbA 1c  <\u20097% ', 'incidence of adverse events', 'safety and efficacy']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic Drugs'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C4517877', 'cui_str': '8.5'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.434165,Significant and dose-dependent placebo-adjusted mean reductions from baseline to week 12 in FPG and body mass were observed.,"[{'ForeName': 'Yuan-Di', 'Initials': 'YD', 'LastName': 'Halvorsen', 'Affiliation': 'Translational Medicine Group, Center for Computational and Integrative Biology, Massachusetts General Hospital, Boston, Massachusetts, United States.'}, {'ForeName': 'Geoffrey', 'Initials': 'G', 'LastName': 'Walford', 'Affiliation': 'Translational Medicine Group, Center for Computational and Integrative Biology, Massachusetts General Hospital, Boston, Massachusetts, United States.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Thurber', 'Affiliation': 'Translational Medicine Group, Center for Computational and Integrative Biology, Massachusetts General Hospital, Boston, Massachusetts, United States.'}, {'ForeName': 'Heidy', 'Initials': 'H', 'LastName': 'Russell', 'Affiliation': 'Prometrika, LLC, Cambridge, Massachusetts.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Massaro', 'Affiliation': 'Prometrika, LLC, Cambridge, Massachusetts.'}, {'ForeName': 'Mason W', 'Initials': 'MW', 'LastName': 'Freeman', 'Affiliation': 'Translational Medicine Group, Center for Computational and Integrative Biology, Massachusetts General Hospital, Boston, Massachusetts, United States.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13928']
738,31672712,"Optimised transcranial direct current stimulation (tDCS) for fibromyalgia-targeting the endogenous pain control system: a randomised, double-blind, factorial clinical trial protocol.","INTRODUCTION


Fibromyalgia (FM) is a common debilitating condition with limited therapeutic options. Medications have low efficacy and are often associated with adverse effects. Given that FM is associated with a defective endogenous pain control system and central sensitisation, combining interventions such as transcranial direct current stimulation (tDCS) and aerobic exercise (AE) to modulate pain-processing circuits may enhance pain control.
METHODS AND ANALYSIS


A prospective, randomised (1:1:1:1), placebo-controlled, double-blind, factorial clinical trial will test the hypothesis that optimised tDCS (16 anodal tDCS sessions combined with AE) can restore of the pain endogenous control system. Participants with FM (n=148) will undergo a conditioning exercise period and be randomly allocated to one of four groups: (1) active tDCS and AE, (2) sham tDCS and AE, (3) active tDCS and non-aerobic exercise (nAE) or (4) sham tDCS and nAE. Pain inhibitory activity will be assessed using conditioned pain modulation (CPM) and temporal slow pain summation (TSPS)-primary outcomes. Secondary outcomes will include the following assessments: Transcranial magnetic stimulation and electroencephalography as cortical markers of pain inhibitory control and thalamocortical circuits; secondary clinical outcomes on pain, FM, quality of life, sleep and depression. Finally, the relationship between the two main mechanistic targets in this study-CPM and TSPS-and changes in secondary clinical outcomes will be tested. The change in the primary efficacy endpoint, CPM and TSPS, from baseline to week 4 of stimulation will be tested with a mixed linear model and adjusted for important demographic variables.
ETHICS AND DISSEMINATION


This study obeys the Declaration of Helsinki and was approved by the Institutional Review Board (IRB) of Partners Healthcare under the protocol number 2017P002524. Informed consent will be obtained from participants. Study findings will be reported in conferences and peer-reviewed journal publications.
TRIAL REGISTRATION NUMBER


NCT03371225.",2019,"The change in the primary efficacy endpoint, CPM and TSPS, from baseline to week 4 of stimulation will be tested with a mixed linear model and adjusted for important demographic variables.
",['Participants with FM (n=148) will undergo a'],"['FM', 'active tDCS and AE, (2) sham tDCS and AE, (3) active tDCS and non-aerobic exercise (nAE) or (4) sham tDCS and nAE', 'placebo', 'conditioning exercise period', 'transcranial direct current stimulation (tDCS) and aerobic exercise (AE', 'transcranial direct current stimulation (tDCS', 'tDCS (16 anodal tDCS sessions combined with AE']","['Pain inhibitory activity', 'Transcranial magnetic stimulation and electroencephalography as cortical markers of pain inhibitory control and thalamocortical circuits; secondary clinical outcomes on pain, FM, quality of life, sleep and depression', 'conditioned pain modulation (CPM) and temporal slow pain summation (TSPS)-primary outcomes']",[],"[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation (procedure)'}, {'cui': 'C0013819', 'cui_str': 'EEG'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0442043', 'cui_str': 'Temporal (qualifier value)'}, {'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C0234108', 'cui_str': 'Summation, function (observable entity)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}]",,0.575632,"The change in the primary efficacy endpoint, CPM and TSPS, from baseline to week 4 of stimulation will be tested with a mixed linear model and adjusted for important demographic variables.
","[{'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Castelo-Branco', 'Affiliation': 'Neuromodulation Center/Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Elif', 'Initials': 'E', 'LastName': 'Uygur Kucukseymen', 'Affiliation': 'Neuromodulation Center/Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Dante', 'Initials': 'D', 'LastName': 'Duarte', 'Affiliation': 'Neuromodulation Center/Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Mirret M', 'Initials': 'MM', 'LastName': 'El-Hagrassy', 'Affiliation': 'Neuromodulation Center/Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Camila', 'Initials': 'C', 'LastName': 'Bonin Pinto', 'Affiliation': 'Neuromodulation Center/Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Muhammed Enes', 'Initials': 'ME', 'LastName': 'Gunduz', 'Affiliation': 'Neuromodulation Center/Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Alejandra', 'Initials': 'A', 'LastName': 'Cardenas-Rojas', 'Affiliation': 'Neuromodulation Center/Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Pacheco-Barrios', 'Affiliation': 'Neuromodulation Center/Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Yiling', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Neuromodulation Center/Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Gonzalez-Mego', 'Affiliation': 'Neuromodulation Center/Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Anayali', 'Initials': 'A', 'LastName': 'Estudillo-Guerra', 'Affiliation': 'Neuromodulation Center/Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Ludmilla', 'Initials': 'L', 'LastName': 'Candido-Santos', 'Affiliation': 'Neuromodulation Center/Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Ines', 'Initials': 'I', 'LastName': 'Mesia-Toledo', 'Affiliation': 'Neuromodulation Center/Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Haley', 'Initials': 'H', 'LastName': 'Rafferty', 'Affiliation': 'Neuromodulation Center/Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Wolnei', 'Initials': 'W', 'LastName': 'Caumo', 'Affiliation': 'Laboratory of Pain & Neuromodulation, Hospital de Clinicas de Porto Alegre da Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Fregni', 'Affiliation': 'Neuromodulation Center/Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, Massachusetts, USA fregni.felipe@mgh.harvard.edu.'}]",BMJ open,['10.1136/bmjopen-2019-032710']
739,30991661,The Effects of Acute and Chronic Aerobic Activity on the Signaling Pathway of the Inflammasome NLRP3 Complex in Young Men.,"Background and Objectives : The results of the studies show that the intensity and volume of aerobic exercise activity produce different responses of the immune system. This study aims to show how the signaling pathway of the inflammatory NLRP3 complex is influenced by the acute and chronic effects of moderate and high-intensity aerobic exercises in young men.  Materials and Methods : Accordingly, 60 healthy (BMI = 23.56 ± 2.67) young (24.4 ± 0.4) students volunteered to participate in the study that was randomly divided into two experimental ( n  = 20) groups and one control ( n  = 20) group. The training protocol started with two intensity levels of 50% for a moderate group and 70% of maximum heart rate for high group for 30 min and then continued until reaching 70% (moderate group) and 90% (high group) of the maximum heart rate, respectively. Using Real Time-PCR method, the expression of NLRP3 gene and ELISA- were measured by IL-1β, IL-18.  Results : The results showed that acute aerobic exercise with moderate intensity had no significant effect on the expression of NLRP3 gene and serum levels of IL-1β and IL-18 cytokines ( p  > 0.05) when acute exercise, with high intensity, begins an initiation of the activity of the inflammatory complex with elevated serum levels of IL-1β, IL-18, and NLRP3 gene expression ( p  < 0.05). In addition, chronic exercise with moderate intensity significantly reduced the expression of NLRP3 gene and serum levels of IL-1β, IL-18 cytokines ( p  < 0.05). In the case of chronic exercise with high intensity, a significant increase in expression of gene, NLRP3 and serum levels of IL-1β, IL-18 cytokines were observed ( p  < 0.05).  Conclusions : Generally, it can be concluded that chronic exercise with moderate intensity is effective in decreasing the expression of the inflammasome and inflammation.",2019,"In the case of chronic exercise with high intensity, a significant increase in expression of gene, NLRP3 and serum levels of IL-1β, IL-18 cytokines were observed ( p  < 0.05).  ","['Young Men', '60 healthy (BMI = 23.56 ± 2.67) young (24.4 ± 0.4) students volunteered to participate in the study that was randomly divided into two experimental ( n  = 20) groups and one control ( n  = 20) group', 'young men']",['Materials and Methods '],"['expression of NLRP3 gene and serum levels of IL-1β, IL-18 cytokines', 'serum levels of IL-1β, IL-18, and NLRP3 gene expression', 'expression of NLRP3 gene and serum levels of IL-1β and IL-18 cytokines', 'expression of gene, NLRP3 and serum levels of IL-1β, IL-18 cytokines', 'expression of NLRP3 gene and ELISA']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4517457', 'cui_str': 'Zero point four'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]","[{'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0383327', 'cui_str': 'Interferon-gamma-Inducing Factor'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0017262', 'cui_str': 'Gene Expression'}, {'cui': 'C0014441', 'cui_str': 'ELISA'}]",,0.0436085,"In the case of chronic exercise with high intensity, a significant increase in expression of gene, NLRP3 and serum levels of IL-1β, IL-18 cytokines were observed ( p  < 0.05).  ","[{'ForeName': 'Iman', 'Initials': 'I', 'LastName': 'Khakroo Abkenar', 'Affiliation': 'Department of Exercise Physiology, Faculty of Sport Sciences, University of Guilan, Rasht 4199613776, Iran. imankhakroo@phd.guilan.ac.ir.'}, {'ForeName': 'Farhad', 'Initials': 'F', 'LastName': 'Rahmani-Nia', 'Affiliation': 'Department of Exercise Physiology, Faculty of Sport Sciences, University of Guilan, Rasht 4199613776, Iran. frahmani2001@yahoo.com.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Lombardi', 'Affiliation': 'IRCCS Istituto Ortopedico Galeazzi, Laboratory of Experimental Biochemistry and Molecular Biology, via Riccardo Galeazzi 4, 20161 Milano, Italia. giovanni.lombardi@grupposandonato.it.'}]","Medicina (Kaunas, Lithuania)",['10.3390/medicina55040105']
740,31005386,"Levetiracetam versus phenytoin for second-line treatment of convulsive status epilepticus in children (ConSEPT): an open-label, multicentre, randomised controlled trial.","BACKGROUND


Phenytoin is the current standard of care for second-line treatment of paediatric convulsive status epilepticus after failure of first-line benzodiazepines, but is only effective in 60% of cases and is associated with considerable adverse effects. A newer anticonvulsant, levetiracetam, can be given more quickly, is potentially more efficacious, and has a more tolerable adverse effect profile. We aimed to determine whether phenytoin or levetiracetam is the superior second-line treatment for paediatric convulsive status epilepticus.
METHODS


ConSEPT was an open-label, multicentre, randomised controlled trial conducted in 13 emergency departments in Australia and New Zealand. Children aged between 3 months and 16 years, with convulsive status epilepticus that failed first-line benzodiazepine treatment, were randomly assigned (1:1) using a computer-generated permuted block (block sizes 2 and 4) randomisation sequence, stratified by site and age (≤5 years, >5 years), to receive 20 mg/kg phenytoin (intravenous or intraosseous infusion over 20 min) or 40 mg/kg levetiracetam (intravenous or intraosseous infusion over 5 min). The primary outcome was clinical cessation of seizure activity 5 min after the completion of infusion of the study drug. Analysis was by intention to treat. This trial is registered with the Australian and New Zealand Clinical Trials Registry, number ACTRN12615000129583.
FINDINGS


Between March 19, 2015, and Nov 29, 2017, 639 children presented to participating emergency departments with convulsive status epilepticus; 127 were missed, and 278 did not meet eligibility criteria. The parents of one child declined to give consent, leaving 233 children (114 assigned to phenytoin and 119 assigned to levetiracetam) in the intention-to-treat population. Clinical cessation of seizure activity 5 min after completion of infusion of study drug occurred in 68 (60%) patients in the phenytoin group and 60 (50%) patients in the levetiracetam group (risk difference -9·2% [95% CI -21·9 to 3·5]; p=0·16). One participant in the phenytoin group died at 27 days because of haemorrhagic encephalitis; this death was not thought to be due to the study drug. There were no other serious adverse events.
INTERPRETATION


Levetiracetam is not superior to phenytoin for second-line management of paediatric convulsive status epilepticus.
FUNDING


Health Research Council of New Zealand, A+ Trust, Emergency Medicine Foundation, Townsville Hospital Private Practice Fund, Eric Ormond Baker Charitable Fund, and Princess Margaret Hospital Foundation.",2019,"INTERPRETATION


Levetiracetam is not superior to phenytoin for second-line management of paediatric convulsive status epilepticus.
","['Children aged between 3 months and 16 years, with convulsive status epilepticus that failed first-line benzodiazepine treatment', 'paediatric convulsive status epilepticus', 'convulsive status epilepticus in children (ConSEPT', '233 children (114 assigned to', '13 emergency departments in Australia and New Zealand', 'Between March 19, 2015, and Nov 29, 2017, 639 children presented to participating emergency departments with convulsive status epilepticus; 127 were missed, and 278 did not meet eligibility criteria']","['Phenytoin', 'phenytoin or levetiracetam', 'Levetiracetam versus phenytoin', 'phenytoin (intravenous or intraosseous infusion over 20 min) or 40 mg/kg levetiracetam (intravenous or intraosseous infusion over 5 min', 'phenytoin', 'levetiracetam']","['serious adverse events', 'clinical cessation of seizure activity']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0311335', 'cui_str': 'Grand Mal Status Epilepticus'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C4708785', 'cui_str': 'One hundred and fourteen'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0031507', 'cui_str': 'Phenytoin'}, {'cui': 'C0377265', 'cui_str': 'Levetiracetam'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0162590', 'cui_str': 'Infusions, Intra-Osseous'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",,0.419303,"INTERPRETATION


Levetiracetam is not superior to phenytoin for second-line management of paediatric convulsive status epilepticus.
","[{'ForeName': 'Stuart R', 'Initials': 'SR', 'LastName': 'Dalziel', 'Affiliation': ""Children's Emergency Department, Starship Children's Hospital, Auckland, New Zealand; Departments of Surgery, University of Auckland, Auckland, New Zealand; Paediatrics: Child and Youth Health, University of Auckland, Auckland, New Zealand. Electronic address: sdalziel@adhb.govt.nz.""}, {'ForeName': 'Meredith L', 'Initials': 'ML', 'LastName': 'Borland', 'Affiliation': ""Perth Children's Hospital, Perth, WA, Australia; Division of Emergency Medicine, School of Medicine, University of Western Australia, Perth, WA, Australia; Division of Paediatrics, School of Medicine, University of Western Australia, Perth, WA, Australia.""}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Furyk', 'Affiliation': 'Emergency Department, The Townsville Hospital, Townsville, QLD, Australia; College of Public Health, Medical and Veterinary Sciences, James Cook University, Townsville, QLD, Australia.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Bonisch', 'Affiliation': ""Children's Emergency Department, Starship Children's Hospital, Auckland, New Zealand.""}, {'ForeName': 'Jocelyn', 'Initials': 'J', 'LastName': 'Neutze', 'Affiliation': 'Kidz First Hospital, Auckland, New Zealand.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Donath', 'Affiliation': ""Murdoch Children's Research Institute, Parkville, VIC, Australia; Department of Paediatrics, University of Melbourne, Melbourne, VIC, Australia.""}, {'ForeName': 'Kate L', 'Initials': 'KL', 'LastName': 'Francis', 'Affiliation': ""Murdoch Children's Research Institute, Parkville, VIC, Australia.""}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Sharpe', 'Affiliation': ""Children's Emergency Department, Starship Children's Hospital, Auckland, New Zealand.""}, {'ForeName': 'A Simon', 'Initials': 'AS', 'LastName': 'Harvey', 'Affiliation': ""Murdoch Children's Research Institute, Parkville, VIC, Australia; Department of Paediatrics, University of Melbourne, Melbourne, VIC, Australia; Royal Children's Hospital, Melbourne, VIC, Australia.""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Davidson', 'Affiliation': ""Murdoch Children's Research Institute, Parkville, VIC, Australia; Royal Children's Hospital, Melbourne, VIC, Australia.""}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Craig', 'Affiliation': 'Monash Medical Centre, Melbourne, VIC, Australia; Department of Medicine, School of Clinical Sciences, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Phillips', 'Affiliation': ""Queensland Children's Hospital, Brisbane, QLD, Australia; Child Health Research Centre, University of Queensland, Brisbane, QLD, Australia.""}, {'ForeName': 'Shane', 'Initials': 'S', 'LastName': 'George', 'Affiliation': 'Child Health Research Centre, University of Queensland, Brisbane, QLD, Australia; Department of Emergency Medicine, Gold Coast University Hospital, Southport, QLD, Australia; School of Medicine, Griffith University, Gold Coast, QLD, Australia.'}, {'ForeName': 'Arjun', 'Initials': 'A', 'LastName': 'Rao', 'Affiliation': ""Sydney Children's Hospital, Randwick, NSW, Australia; School of Women's and Children's Health, University of New South Wales, Sydney, NSW, Australia.""}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Cheng', 'Affiliation': ""Children's Hospital at Westmead, Sydney, NSW, Australia.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Emergency Department, John Hunter Hospital, Newcastle, NSW, Australia.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Kochar', 'Affiliation': ""Emergency Department, Women's and Children's Hospital, Adelaide, SA, Australia.""}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Brabyn', 'Affiliation': 'Emergency Department, Waikato Hospital, Hamilton, New Zealand.'}, {'ForeName': 'Ed', 'Initials': 'E', 'LastName': 'Oakley', 'Affiliation': ""Murdoch Children's Research Institute, Parkville, VIC, Australia; Department of Paediatrics, University of Melbourne, Melbourne, VIC, Australia; Royal Children's Hospital, Melbourne, VIC, Australia.""}, {'ForeName': 'Franz E', 'Initials': 'FE', 'LastName': 'Babl', 'Affiliation': ""Murdoch Children's Research Institute, Parkville, VIC, Australia; Department of Paediatrics, University of Melbourne, Melbourne, VIC, Australia; Royal Children's Hospital, Melbourne, VIC, Australia.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(19)30722-6']
741,31066313,Improving social participation of adolescents with a visual impairment with community-based mentoring: results from a randomized controlled trial.,"Purpose:  The efficacy of a community-based mentoring program for adolescents with a visual impairment vs. care-as-usual was tested on social participation including satisfaction with social support. Materials and methods:  Adolescents (15-22 years; 46% boys) were randomized to an intervention group with mentors with visual impairment ( N  = 25), an intervention group with mentors without visual impairment ( N  = 26), or care-as-usual ( N  = 25). One-on-one mentoring activities regarded school/work, leisure activities, and social relationships. Results and conclusions:  Multilevel growth modelling revealed no effect of mentoring on changes in social participation compared to the care-as-usual group (participation [95% CI -0.30, 0.21,  d  = 0.1]; social participation composite [95% CI -0.24, 0.26,  d  = 0.24]). Mentees matched to mentors with visual impairments increased more on satisfaction with their social support compared to mentees matched to mentors without impairments and the care-as-usual group [95% CI 0.02, 0.49,  d  = 0.38]. Age, characteristics of the impairment, and number of match meetings were not associated with change in social participation during the mentoring program. This evaluation showed no benefit of mentoring for social participation of adolescents with a visual impairment. The value of mentors and mentees sharing the same disability needs further investigation. This trial is registered in the Netherlands Trial Register NTR4768.Implications for rehabilitationA community-based mentoring program resulted in no benefits for adolescents with a visual impairment on their social participation.A community-based mentoring program should not replace care-as-usual provided to young people with a visual impairment in the Netherlands. It could only be thought of as an additional service within rehabilitation.Matching mentees and mentors based on sharing the same disability could strengthen the effect of a community-based mentoring program. However, these benefits are rather small.Providing additional support for the social participation of young people with a visual impairment might be especially helpful for those with a progressive impairment and with comorbid problems.",2020,"Multilevel growth modelling revealed no effect of mentoring on changes in social participation compared to the care-as-usual group (participation [95% CI -0.30, 0.21, d = 0.1]; social participation composite [95% CI -0.24, 0.26, d = 0.24]).","['adolescents with a visual impairment', 'adolescents with a visual impairment with community-based mentoring', 'young people with a visual impairment', 'adolescents with a visual impairment on their social participation', 'Adolescents (15-22\xa0years; 46% boys', 'young people with a visual impairment in the Netherlands', 'adolescents with a visual impairment vs. care-as-usual was tested on social participation including satisfaction with social support']","['intervention group with mentors with visual impairment (N\u2009=\u200925), an intervention group with mentors without visual impairment (N\u2009=\u200926), or care-as-usual', 'community-based mentoring program']","['social participation', 'satisfaction with their social support', 'social participation composite']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C3665347', 'cui_str': 'Visual Impairment'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0025369', 'cui_str': 'Mentors'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0814554', 'cui_str': 'Social Participation'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0037438'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0025369', 'cui_str': 'Mentors'}, {'cui': 'C3665347', 'cui_str': 'Visual Impairment'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C4255266', 'cui_str': 'Mentoring'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0814554', 'cui_str': 'Social Participation'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0037438'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}]",,0.0739421,"Multilevel growth modelling revealed no effect of mentoring on changes in social participation compared to the care-as-usual group (participation [95% CI -0.30, 0.21, d = 0.1]; social participation composite [95% CI -0.24, 0.26, d = 0.24]).","[{'ForeName': 'Eline C M', 'Initials': 'ECM', 'LastName': 'Heppe', 'Affiliation': 'Faculty of Behavioural and Movement Sciences, Section of Clinical Child and Family Studies, Vrije Unviersiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Agnes M', 'Initials': 'AM', 'LastName': 'Willemen', 'Affiliation': 'Faculty of Behavioural and Movement Sciences, Section of Clinical Child and Family Studies, Vrije Unviersiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Sabina', 'Initials': 'S', 'LastName': 'Kef', 'Affiliation': 'Faculty of Behavioural and Movement Sciences, Section of Clinical Child and Family Studies, Vrije Unviersiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Schuengel', 'Affiliation': 'Faculty of Behavioural and Movement Sciences, Section of Clinical Child and Family Studies, Vrije Unviersiteit Amsterdam, Amsterdam, The Netherlands.'}]",Disability and rehabilitation,['10.1080/09638288.2019.1589587']
742,31709423,Predicting Response to the Antidepressant Bupropion using Pretreatment fMRI.,"Major depressive disorder is a primary cause of disability in adults with a lifetime prevalence of 6-21% worldwide. While medical treatment may provide symptomatic relief, response to any given antidepressant is unpredictable and patient-specific. The standard of care requires a patient to sequentially test different antidepressants for 3 months each until an optimal treatment has been identified. For 30-40% of patients, no effective treatment is found after more than one year of this trial-and-error process, during which a patient may suffer loss of employment or marriage, undertreated symptoms, and suicidal ideation. This work develops a predictive model that may be used to expedite the treatment selection process by identifying for individual patients whether the patient will respond favorably to bupropion, a widely prescribed antidepressant, using only pretreatment imaging data. This is the first model to do so for individuals for bupropion. Specifically, a deep learning predictor is trained to estimate the 8-week change in Hamilton Rating Scale for Depression (HAMD) score from pretreatment task-based functional magnetic resonance imaging (fMRI) obtained in a randomized controlled antidepressant trial. An unbiased neural architecture search is conducted over 800 distinct model architecture and brain parcellation combinations, and patterns of model hyperparameters yielding the highest prediction accuracy are revealed. The winning model identifies bupropion-treated subjects who will experience remission with the number of subjects needed-to-treat (NNT) to lower morbidity of only 3.2 subjects. It attains a substantially high neuroimaging study effect size explaining 26% of the variance ( R   2  = 0.26) and the model predicts post-treatment change in the 52-point HAMD score with an RMSE of 4.71. These results support the continued development of fMRI and deep learning-based predictors of response for additional depression treatments.",2019,"For 30-40% of patients, no effective treatment is found after more than one year of this trial-and-error process, during which a patient may suffer loss of employment or marriage, undertreated symptoms, and suicidal ideation.",['adults with a lifetime prevalence of 6-21% worldwide'],['bupropion'],['Hamilton Rating Scale for Depression (HAMD) score'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}]","[{'cui': 'C0085208', 'cui_str': 'Bupropion'}]","[{'cui': 'C4545802', 'cui_str': 'HAM-D (Hamilton Rating Scale for Depression) score'}]",800.0,0.0353977,"For 30-40% of patients, no effective treatment is found after more than one year of this trial-and-error process, during which a patient may suffer loss of employment or marriage, undertreated symptoms, and suicidal ideation.","[{'ForeName': 'Kevin P', 'Initials': 'KP', 'LastName': 'Nguyen', 'Affiliation': 'University of Texas Southwestern Medical Center.'}, {'ForeName': 'Cherise Chin', 'Initials': 'CC', 'LastName': 'Fatt', 'Affiliation': 'University of Texas Southwestern Medical Center.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Treacher', 'Affiliation': 'University of Texas Southwestern Medical Center.'}, {'ForeName': 'Cooper', 'Initials': 'C', 'LastName': 'Mellema', 'Affiliation': 'University of Texas Southwestern Medical Center.'}, {'ForeName': 'Madhukar H', 'Initials': 'MH', 'LastName': 'Trivedi', 'Affiliation': 'University of Texas Southwestern Medical Center.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Montillo', 'Affiliation': 'University of Texas Southwestern Medical Center.'}]",PRedictive Intelligence in MEdicine. PRIME (Workshop),['10.1007/978-3-030-32281-6_6']
743,32410683,Effect of ulinastatin on post-operative blood loss and allogeneic transfusion in patients receiving cardiac surgery with cardiopulmonary bypass: a prospective randomized controlled study with 10-year follow-up.,"BACKGROUND


Major bleeding and allogeneic transfusion leads to negative outcomes in patients receiving cardiac surgery with cardiopulmonary bypass (CPB). Ulinastatin, a urine trypsin inhibitor, relieves systemic inflammation and improves coagulation profiles with however sparse evidence of its effects on blood loss and allogeneic transfusion in this specific population.
METHODS


In this prospective randomized controlled trial, 426 consecutive patients receiving open heart surgery with CPB were randomly assigned into three groups to receive ulinastatin (group U, n = 142), tranexamic acid (group T, n = 143) or normal saline (group C, n = 141). The primary outcome was the total volume of post-operative bleeding and the secondary outcome included the volume and exposure of allogeneic transfusion, the incidence of stroke, post-operative myocardial infarction, renal failure, respiratory failure and all-cause mortality. A ten-year follow-up was carried on to evaluate long-term safety.
RESULTS


Compared with placebo, ulinastatin significantly reduced the volume of post-operative blood loss within 24 h (688.39 ± 393.55 ml vs 854.33 ± 434.03 ml MD - 165.95 ml, 95%CI - 262.88 ml to - 69.01 ml, p < 0.001) and the volume of allogeneic erythrocyte transfusion (2.57 ± 3.15 unit vs 3.73 ± 4.21 unit, MD-1.16 unit, 95%CI - 2.06 units to - 0.26 units, p = 0.002). The bleeding and transfusion outcomes were comparable between the ulinastatin group and the tranexamic acid group. In-hospital outcomes and 10-year follow-up showed no statistical difference in mortality and major morbidity among groups.
CONCLUSIONS


Ulinastatin reduced post-operative blood loss and allogeneic erythrocyte transfusion in heart surgery with CPB. The mortality and major morbidity was comparable among the groups shown by the 10-year follow-up.
TRIAL REGISTRATION


The trial was retrospectively registered on February 2, 2010.
TRIAL REGISTRATION NUMBER


https://www.clinicaltrials.gov Identifier: NCT01060189.",2020,"In-hospital outcomes and 10-year follow-up showed no statistical difference in mortality and major morbidity among groups.
","['patients receiving cardiac surgery with cardiopulmonary bypass (CPB', 'heart surgery with CPB', '426 consecutive patients receiving open heart surgery with CPB', 'patients receiving cardiac surgery with cardiopulmonary bypass']","['Ulinastatin', 'normal saline', 'placebo, ulinastatin', 'tranexamic acid', 'ulinastatin']","['blood loss and allogeneic transfusion', 'volume of post-operative blood loss', 'bleeding and transfusion outcomes', 'mortality and major morbidity', 'total volume of post-operative bleeding and the secondary outcome included the volume and exposure of allogeneic transfusion, the incidence of stroke, post-operative myocardial infarction, renal failure, respiratory failure and all-cause mortality', 'volume of allogeneic erythrocyte transfusion']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0189745', 'cui_str': 'Open heart surgery'}]","[{'cui': 'C0077906', 'cui_str': 'urinastatin'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C0086252', 'cui_str': 'Transfusion of red blood cells'}]",426.0,0.171357,"In-hospital outcomes and 10-year follow-up showed no statistical difference in mortality and major morbidity among groups.
","[{'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Department of Surgery, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, 167 Beilishi Rd., Xicheng District, Beijing, 100037, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Lv', 'Affiliation': 'Department of Anaesthesiology, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, 167 Beilishi Rd., Xicheng District, Beijing, 100037, China.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Qi', 'Affiliation': ""Department of Anaesthesiology, People's Hospital of Ningxia Hui Autonomous Region, 148 Huaiyuanxi Rd. Xixia District, Ningxia Hui Autonomous Region, Yinchuan, 750021, China.""}, {'ForeName': 'Wenjing', 'Initials': 'W', 'LastName': 'Xiao', 'Affiliation': 'Department of Anaesthesiology, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, 167 Beilishi Rd., Xicheng District, Beijing, 100037, China.'}, {'ForeName': 'Qinghua', 'Initials': 'Q', 'LastName': 'Xue', 'Affiliation': 'Department of Anaesthesiology, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, 167 Beilishi Rd., Xicheng District, Beijing, 100037, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Anaesthesiology, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, 167 Beilishi Rd., Xicheng District, Beijing, 100037, China.'}, {'ForeName': 'Lihuan', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Anaesthesiology, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, 167 Beilishi Rd., Xicheng District, Beijing, 100037, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Shi', 'Affiliation': 'Department of Anaesthesiology, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, 167 Beilishi Rd., Xicheng District, Beijing, 100037, China. shijia@fuwai.com.'}]",Journal of cardiothoracic surgery,['10.1186/s13019-020-01144-9']
744,31724878,Efficacy of Intermittently Scanned Continuous Glucose Monitoring in the Prevention of Recurrent Severe Hypoglycemia.,"Background:  People with diabetes experiencing hypoglycemia are at increased risk of recurrence because of attenuated autonomic warning. We assessed the efficacy of intermittently scanned continuous glucose monitoring (isCGM; FreeStyle Libre™, Abbott) compared with usual-care self-monitoring of blood glucose (SMBG) in reducing this risk in type 1 and insulin-treated type 2 diabetes.  Methods:  Insulin-treated adults with diabetes and an episode of clinically significant biochemical hypoglycemia (blood glucose [BG] <3.0 mM) or symptomatic hypoglycemia and BG <4.0 mM were randomized to 6 months of isCGM (intensive group) or SMBG (control group) against a background of usual care. The primary outcome was hypoglycemia requiring second-party assistance for recovery. Prespecified secondary outcomes included other hypoglycemic episodes (self-reported, and BG <3.0, 3.0-3.9, <4.0 mM) and change in HbA 1c  at 24 weeks.  Results:  Of 59 participants (mean age 53.6 years, 44.1% males, median HbA 1c  61.8 mmol/mol or 7.8%), 30 were allocated to isCGM and 29 to SMBG. The incidence of severe hypoglycemia was not significantly different between the two groups (incident rate ratio [95% confidence interval]: 1.49 [0.46-5.56],  P  = 0.47). The incidence of other recorded hypoglycemic episodes in the intervention group was double that in the control group ( P  < 0.001). There was no difference in the change in HbA 1c  between the two groups ( P  = 0.74). There were seven serious adverse events and none was considered related to the intervention.  Conclusions:  Although isCGM is safe, it does not appear to have a role in preventing recurrent severe hypoglycemia in at-risk individuals with diabetes.",2020,The incidence of other recorded hypoglycemic episodes in the intervention group was double that in the control group (P<0.001).,"['People with diabetes experiencing hypoglycemia', 'type 1 and insulin-treated type 2 diabetes', 'mean age 53.6 years, 44.1% males, median HbA1c 61.8 mmol/mol or 7.8%), 30 were allocated to isCGM and 29 to SMBG', 'Insulin-treated adults with diabetes and an episode of clinically significant biochemical hypoglycemia (blood glucose (BG) <3.0 mmol/L) or symptomatic hypoglycaemia and BG <4.0 mmol/L', '59 participants']","['intermittently scanned continuous glucose monitoring (isCGM; FreeStyle LibreTM, Abbott) compared with usual care (self-monitoring of blood glucose; SMBG', 'isCGM', 'intermittently scanned continuous glucose monitoring', 'isCGM (intensive group) or SMBG (control group) against a background of usual care']","['hypoglycemic episodes (self-reported, and BG', 'hypoglycemia requiring second party assistance for recovery', 'incidence of other recorded hypoglycemic episodes', 'incidence of severe hypoglycemia', 'recurrent severe hypoglycemia', 'change in HbA1c']","[{'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C1532563', 'cui_str': 'umol/mL'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}]","[{'cui': 'C0441633'}, {'cui': 'C4523945', 'cui_str': 'Continuous glucose monitoring'}, {'cui': 'C0005803', 'cui_str': 'Monitoring, Home Blood Glucose'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0020616', 'cui_str': 'Hypoglycemic Drugs'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0745153', 'cui_str': 'Hypoglycemic attack'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0342316', 'cui_str': 'Recurrent severe hypoglycemia (disorder)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}]",59.0,0.136749,The incidence of other recorded hypoglycemic episodes in the intervention group was double that in the control group (P<0.001).,"[{'ForeName': 'Timothy M E', 'Initials': 'TME', 'LastName': 'Davis', 'Affiliation': 'Medical School, Fremantle Hospital, University of Western Australia, Fremantle, Australia.'}, {'ForeName': 'Penny', 'Initials': 'P', 'LastName': 'Dwyer', 'Affiliation': 'Medical School, Fremantle Hospital, University of Western Australia, Fremantle, Australia.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'England', 'Affiliation': 'Medical School, Fremantle Hospital, University of Western Australia, Fremantle, Australia.'}, {'ForeName': 'P Gerry', 'Initials': 'PG', 'LastName': 'Fegan', 'Affiliation': 'Department of Endocrinology and Diabetes, Fiona Stanley Hospital, Perth, Australia.'}, {'ForeName': 'Wendy A', 'Initials': 'WA', 'LastName': 'Davis', 'Affiliation': 'Medical School, Fremantle Hospital, University of Western Australia, Fremantle, Australia.'}]",Diabetes technology & therapeutics,['10.1089/dia.2019.0331']
745,31719675,Longitudinal neovascular changes on optical coherence tomography angiography in proliferative diabetic retinopathy treated with panretinal photocoagulation alone versus with intravitreal conbercept plus panretinal photocoagulation: a pilot study.,"PURPOSE


To investigate the longitudinal changes in neovascularization of the retinal elsewhere (NVE) size on optical coherence tomography angiography (OCTA) in proliferative diabetic retinopathy (PDR) treated by panretinal photocoagulation (PRP) alone or by single intravitreal conbercept injection plus PRP.
METHODS


A prospective pilot study. Forty-four PDR eyes with NVE confirmed by fundus fluorescein angiography (FFA) and OCTA were included. They were assigned to receive PRP alone (PRP group) or intravitreal conbercept injection plus PRP (combination group). Ophthalmic examinations, including BCVA and OCTA to measure the NVE size, were performed at baseline before each PRP session, and at 1, 3, and 6 months.
RESULTS


Twenty-nine eyes were included in the PRP group, and 15 eyes were included in the combination group. There was no significant difference between the two groups with respect to age, BCVA, and NVE area at baseline. In both groups, there was a significant (P < 0.05) NVE size reduction during the majority of study visits, with the reduction observed in the combination group significantly larger than that in the PRP group. No significant BCVA changes were observed in either groups, except that in the PRP group, the BCVA at 3 months was significantly improved (P < 0.05). No deaths or unexpected adverse events (AEs) were reported.
CONCLUSIONS


Intravitreal conbercept plus PRP was more effective than PRP monotherapy in NVE regression. Precise quantification of the NVE area by OCTA makes it a useful tool for monitoring the response of retinal neovascular lesions to the therapy.",2020,"There was no significant difference between the two groups with respect to age, BCVA, and NVE area at baseline.","['proliferative diabetic retinopathy treated with', 'Forty-four PDR eyes with NVE confirmed by fundus fluorescein angiography (FFA) and OCTA were included', 'proliferative diabetic retinopathy (PDR', 'Twenty-nine eyes were included in the PRP group, and 15 eyes were included in the combination group']","['optical coherence tomography angiography', 'intravitreal conbercept plus panretinal photocoagulation', 'PRP alone (PRP group) or intravitreal conbercept injection plus PRP', 'panretinal photocoagulation alone', 'panretinal photocoagulation (PRP) alone or by single intravitreal conbercept injection plus PRP', 'optical coherence tomography angiography (OCTA']","['No deaths or unexpected adverse events (AEs', 'NVE size reduction', 'BCVA changes', 'BCVA and OCTA to measure the NVE size', 'BCVA']","[{'cui': 'C0154830', 'cui_str': 'PDR - proliferative diabetic retinopathy'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by (contextual qualifier) (qualifier value)'}, {'cui': 'C0430878', 'cui_str': 'Retinal angiography'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0450351', 'cui_str': '29 (qualifier value)'}, {'cui': 'C0242848', 'cui_str': 'PrP (GSS)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0920367', 'cui_str': 'Tomography, Optical Coherence'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C2352201', 'cui_str': 'KH902 fusion protein'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0730064', 'cui_str': 'Scatter retinal laser photocoagulation'}, {'cui': 'C0242848', 'cui_str': 'PrP (GSS)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",44.0,0.0175467,"There was no significant difference between the two groups with respect to age, BCVA, and NVE area at baseline.","[{'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'He', 'Affiliation': 'Department of Ophthalmology, Peking Union Medical College Hospital, Key Lab of Ocular Fundus Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Weihong', 'Initials': 'W', 'LastName': 'Yu', 'Affiliation': 'Department of Ophthalmology, Peking Union Medical College Hospital, Key Lab of Ocular Fundus Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. yuweihongeye@foxmail.com.'}]","Eye (London, England)",['10.1038/s41433-019-0628-3']
746,32082609,Standard care informed by the result of a placental growth factor blood test versus standard care alone in women with reduced fetal movement at or after 36 +0  weeks' gestation: a pilot randomised controlled trial.,"Background


Biomarkers of placental function can potentially aid the diagnosis and prediction of pregnancy complications. This randomised controlled pilot trial assessed whether for women with reduced fetal movement (RFM), intervention directed by the measurement of a placental biomarker in addition to standard care was feasible and improved pregnancy outcome compared with standard care alone.
Methods


Women aged 16-50 years presenting at eight UK maternity units with RFM between 36 +0  and 41 +0  weeks' gestation with a viable singleton pregnancy and no indication for immediate delivery were eligible. Participants were randomised 1:1 in an unblinded manner to standard care and a biomarker blood test result revealed and acted on (intervention arm) or standard care where the biomarker result was not available (control arm). The objectives were to determine the feasibility of a main trial by recruiting 175-225 participants over 9 months and to provide proof of concept that informing care by measurement of placental biomarkers may improve outcome. Feasibility was assessed via the number of potentially eligible women, number recruited, reasons for non-recruitment and compliance. Proof of concept outcomes included the rates of the induction of labour and caesarean birth, and a composite adverse pregnancy outcome.
Results


Overall, 2917 women presented with RFM ≥ 36 weeks, 352 were approached to participate and 216 (61%) were randomised (intervention  n  = 109, control  n  = 107). The main reason for not approaching women was resource/staff issues ( n  = 1510). Ninety-seven women declined the trial, mainly due to not liking blood tests ( n  = 24) or not wanting to be in a trial ( n  = 21). Compliance with the trial interventions was 100% in both arms. Labour was induced in 97 (45%) participants (intervention  n  = 49, control  n  = 48), while 17 (9%) had planned caesarean sections (intervention  n  = 9, control  n  = 8). Overall, 9 (8%) babies in the intervention arm had the composite adverse pregnancy outcome versus 4 (4%) in the control arm.
Conclusions


A main trial using a placental biomarker in combination with delivery, as indicated by the biomarker, in women with RFM is feasible. The frequency of adverse outcomes in this population is low, hence, a large sample size would be required along with consideration of the most appropriate outcome measures.
Trial registration


ISRCTN, ISRCTN12067514; registered 8 September 2017.",2020,"Labour was induced in 97 (45%) participants (intervention  n  = 49, control  n  = 48), while 17 (9%) had planned caesarean sections (intervention  n  = 9, control  n  = 8).","[""Methods\n\n\nWomen aged 16-50\u2009years presenting at eight UK maternity units with RFM between 36 +0  and 41 +0 \u2009weeks' gestation with a viable singleton pregnancy and no indication for immediate delivery were eligible"", 'women with RFM', '2917 women presented with RFM\u2009≥\u200936\u2009weeks, 352 were approached to participate and 216 (61', 'women with reduced fetal movement (RFM', 'Ninety-seven women declined the trial, mainly due to not liking blood tests ( n  = 24) or not wanting to be in a trial ( n  = 21', ""women with reduced fetal movement at or after 36 +0  weeks' gestation""]","['standard care and a biomarker blood test result revealed and acted on (intervention arm) or standard care where the biomarker result was not available (control arm', 'standard care alone', 'placental growth factor blood test versus standard care alone', 'planned caesarean sections (intervention  n  = 9, control  n  = 8']","['Labour', 'composite adverse pregnancy outcome', 'rates of the induction of labour and caesarean birth, and a composite adverse pregnancy outcome']","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0443348', 'cui_str': 'Viable (qualifier value)'}, {'cui': 'C0521090', 'cui_str': 'No indication of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C4708905', 'cui_str': 'Two hundred and sixteen'}, {'cui': 'C0235659', 'cui_str': 'Reduced fetal movement (finding)'}, {'cui': 'C0439073', 'cui_str': '97 (qualifier value)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0018941', 'cui_str': 'Blood Tests'}, {'cui': 'C1444649', 'cui_str': 'Not wanted'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0018941', 'cui_str': 'Blood Tests'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0443289', 'cui_str': 'Revealed (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0018284', 'cui_str': 'Growth factor (substance)'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0007876', 'cui_str': 'C-Section (OB)'}]","[{'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0032972', 'cui_str': 'Pregnancy Outcome'}, {'cui': 'C0259787', 'cui_str': 'Labor Induction'}, {'cui': 'C0005615', 'cui_str': 'Birth'}]",2917.0,0.178429,"Labour was induced in 97 (45%) participants (intervention  n  = 49, control  n  = 48), while 17 (9%) had planned caesarean sections (intervention  n  = 9, control  n  = 8).","[{'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Armstrong-Buisseret', 'Affiliation': '1Nottingham Clinical Trials Unit (NCTU), Building 42, University of Nottingham, University Park, Nottingham, NG7 2RD UK.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Godolphin', 'Affiliation': '1Nottingham Clinical Trials Unit (NCTU), Building 42, University of Nottingham, University Park, Nottingham, NG7 2RD UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Bradshaw', 'Affiliation': '1Nottingham Clinical Trials Unit (NCTU), Building 42, University of Nottingham, University Park, Nottingham, NG7 2RD UK.'}, {'ForeName': 'Eleanor', 'Initials': 'E', 'LastName': 'Mitchell', 'Affiliation': '1Nottingham Clinical Trials Unit (NCTU), Building 42, University of Nottingham, University Park, Nottingham, NG7 2RD UK.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Ratcliffe', 'Affiliation': ""2Maternal and Fetal Health Research Centre, 5th Floor (Research), St Mary's Hospital, Oxford Road, Manchester, M13 9WL UK.""}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Storey', 'Affiliation': ""3International Stillbirth Alliance, c/o Maternal and Fetal Health Research Centre, 5th Floor (Research,), St Mary's Hospital, Oxford Road, Manchester, M13 9WL UK.""}, {'ForeName': 'Alexander E P', 'Initials': 'AEP', 'LastName': 'Heazell', 'Affiliation': ""2Maternal and Fetal Health Research Centre, 5th Floor (Research), St Mary's Hospital, Oxford Road, Manchester, M13 9WL UK.""}]",Pilot and feasibility studies,['10.1186/s40814-020-0561-z']
747,31711154,Feasibility and acceptability of an intervention for enhancing reintegration in adults with experience of homelessness.,"BACKGROUND


Service centres for homeless adults are potential settings for implementation of reintegration interventions. This study aimed to evaluate (i) the acceptability of a group-based programme among individuals from the broad population of homeless people and (ii) if a future study of its feasibility and acceptability for re-housed homeless people is warranted.
METHODS


Recruiting participants and intervention facilitators from partnering service centres was thought to improve recruitment and retention, cost-effectiveness and social interactions compared to professional-led interventions. Seven adults with experience of homelessness (three females, four males, mean age 39 years, range 18-63) were recruited to participate in the intervention. The research protocol comprised completion pre/post of scales [Recovering Quality of Life questionnaire; Working Alliance Inventory-short form revised (WAI-SR)] and focus groups, and WAI-SR and focus groups after sessions 3 and 6.
RESULTS


The intervention and research protocols were feasible, with all participants engaging in all sessions, completing all scales and attending all focus groups. The quantitative data demonstrated the feasibility of obtaining practically useful measures of relevant outcomes. In the four focus groups, the intervention received very favourable feedback.
CONCLUSIONS


This study demonstrated initial feasibility and acceptability of an intervention that places minimal burden on infrastructure and promotes user autonomy. This is an important advance as there is increasing recognition that the challenge of reintegration is as much a psychological and social problem as a housing problem. If effective, this style of intervention may serve as a template for future interventions with similar populations.",2020,"In the four focus groups, the intervention received very favourable feedback.
","['individuals from the broad population of homeless people and (ii', 'Seven adults with experience of homelessness (three females, four males, mean age 39\u2009years, range 18-63', 'Recruiting participants and intervention facilitators from partnering service centres', 'homeless adults', 'adults with experience of homelessness']",['Alliance Inventory-short form revised (WAI-SR'],"['recruitment and retention, cost-effectiveness and social interactions', 'Feasibility and acceptability']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0237154', 'cui_str': 'Homelessness'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}]","[{'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0037420', 'cui_str': 'Social Interaction'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",7.0,0.0405919,"In the four focus groups, the intervention received very favourable feedback.
","[{'ForeName': 'Eva C', 'Initials': 'EC', 'LastName': 'Sundin', 'Affiliation': 'Department of Psychology, Nottingham Trent University, Nottingham, UK.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Mrowiec', 'Affiliation': 'Department of Psychology, Nottingham Trent University, Nottingham, UK.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Bowpitt', 'Affiliation': 'Department of Psychology, Nottingham Trent University, Nottingham, UK.'}, {'ForeName': 'Charlotte A', 'Initials': 'CA', 'LastName': 'Boatman', 'Affiliation': 'Department of Psychology, Nottingham Trent University, Nottingham, UK.'}, {'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'Williams', 'Affiliation': 'Department of Psychology, Nottingham Trent University, Nottingham, UK.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Sarkar', 'Affiliation': 'Department of Sport and Exercise Psychology, Nottingham Trent University, Nottingham, UK.'}, {'ForeName': 'Thom S', 'Initials': 'TS', 'LastName': 'Baguley', 'Affiliation': 'Department of Psychology, Nottingham Trent University, Nottingham, UK.'}]",European journal of public health,['10.1093/eurpub/ckz202']
748,24375159,Pentoxifylline decreases serum level of adhesion molecules in atherosclerosis patients.,"BACKGROUND


Inflammation is involved in development, progression, and complications of atherosclerotic disease. Clinical studies have indicated that the level of monocyte chemoattractant protein 1 (MCP-1), IL-18, and adhesion molecules correlates with the severity of atherosclerosis and can predict future cardiovascular events. Experimental studies have shown pentoxifylline (PTX) reduces these factors in animal models. The purpose of the present pilot study was to evaluate effect of PTX on a group of inflammatory biomarkers in patients with coronary artery disease (CAD).
METHODS


Forty patients with angiographically documented CAD, who fulfilled inclusion and exclusion criteria, were entered in the double-blind, randomized, pilot clinical study. The patients were randomly given PTX (400 mg three times daily) or placebo (3 tab/day) for 2 months. Serum concentrations of MCP-1, IL-18, intercellular adhesion Molecule 1 (ICAM-1), and vascular cell adhesion molecule 1 (VCAM-1) were measured before and at the end of intervention by enzyme-linked immunosorbant assay.
RESULTS


Our study showed that the serum levels of ICAM-1 and VCAM-1 was decreased in the study population after two-month treatment (P<0.05).
CONCLUSION


Based on the results of our pilot study, administration of PTX in CAD patients significantly decreases adhesion molecules levels.",2014,"Serum concentrations of MCP-1, IL-18, intercellular adhesion Molecule 1 (ICAM-1), and vascular cell adhesion molecule 1 (VCAM-1) were measured before and at the end of intervention by enzyme-linked immunosorbant assay.
","['patients with coronary artery disease (CAD', 'atherosclerosis patients', 'Forty patients with angiographically documented CAD, who fulfilled inclusion and exclusion criteria']","['pentoxifylline (PTX', 'PTX', 'placebo', 'Pentoxifylline']","['serum levels of ICAM-1 and VCAM-1', 'Serum concentrations of MCP-1, IL-18, intercellular adhesion Molecule 1 (ICAM-1), and vascular cell adhesion molecule 1 (VCAM-1', 'serum level of adhesion molecules', 'adhesion molecules levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0030899', 'cui_str': 'Pentoxifylline'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0063695', 'cui_str': 'CD54 Antigens'}, {'cui': 'C0078056', 'cui_str': 'CD106 Antigens'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0383327', 'cui_str': 'Interferon-gamma-Inducing Factor'}, {'cui': 'C0001511', 'cui_str': 'Tissue Adhesions'}, {'cui': 'C0567416', 'cui_str': 'Molecule (substance)'}]",40.0,0.097307,"Serum concentrations of MCP-1, IL-18, intercellular adhesion Molecule 1 (ICAM-1), and vascular cell adhesion molecule 1 (VCAM-1) were measured before and at the end of intervention by enzyme-linked immunosorbant assay.
","[{'ForeName': 'Amir Hooshang', 'Initials': 'AH', 'LastName': 'Mohammadpour', 'Affiliation': 'Dept. of Pharmacodynamy and Toxicology, School of Pharmacy, Mashhad University of Medical Science, Mashhad, Iran.'}, {'ForeName': 'Homa', 'Initials': 'H', 'LastName': 'Falsoleiman', 'Affiliation': 'Cardiovascular Research Center, Ghaem Hospital, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Jamal', 'Initials': 'J', 'LastName': 'Shamsara', 'Affiliation': 'Pharmaceutical Research Center, School of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Ghazaleh', 'Initials': 'G', 'LastName': 'Allah Abadi', 'Affiliation': 'Nanotechnology Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Ramin', 'Initials': 'R', 'LastName': 'Rasooli', 'Affiliation': 'Pharmaceutical Research Center, School of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Ramezani', 'Affiliation': 'Pharmaceutical Research Center, School of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran.'}]",Iranian biomedical journal,[]
749,31808298,Dual glucagon-like peptide-1 receptor/glucagon receptor agonist SAR425899 improves beta-cell function in type 2 diabetes.,"AIM


To evaluate the change in insulin sensitivity, β-cell function and glucose absorption after 28 days of treatment with high and low doses of SAR425899, a novel dual glucagon-like peptide-1 receptor/glucagon receptor agonist, versus placebo.
MATERIALS AND METHODS


Thirty-six overweight to obese subjects with type 2 diabetes were randomized to receive daily subcutaneous administrations of low-dose SAR425899 (0.03, 0.06 and 0.09 mg) and high-dose SAR425899 (0.06, 0.12 and 0.18 mg) or placebo for 28 days; dose escalation occurred after days 7 and 14. Mixed meal tolerance tests were conducted before treatment (day -1) and on days 1 and 28. Oral glucose and C-peptide minimal models were used to quantify metabolic indices of insulin sensitivity, β-cell responsiveness and glucose absorption.
RESULTS


With low-dose SAR425899, high-dose SAR425899 and placebo, β-cell function from day -1 to day 28 increased by 163%, 95% and 23%, respectively. The change in area under the curve for the rate of meal glucose appearance between 0 and 120 minutes was -32%, -20% and 8%, respectively.
CONCLUSIONS


After 28 days of treatment, SAR425899 improved postprandial glucose control by significantly enhancing β-cell function and slowing glucose absorption rate.",2020,"After 28 days of treatment, SAR425899 improved postprandial glucose control by significantly enhancing β-cell function and slowing glucose absorption rate.","['Thirty-six overweight to obese subjects with type 2 diabetes', 'type 2 diabetes']","['placebo', 'Dual glucagon-like peptide-1 receptor/glucagon receptor agonist SAR425899', 'SAR425899', 'daily subcutaneous administrations of low-dose SAR425899']","['rate of meal glucose appearance', 'metabolic indices of insulin sensitivity, β-cell responsiveness and glucose absorption', 'postprandial glucose control', 'insulin sensitivity, β-cell function and glucose absorption', 'beta-cell function', 'β-cell function and slowing glucose absorption rate']","[{'cui': 'C4319606', 'cui_str': 'Thirty-six'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0378073', 'cui_str': 'GLP-1 Receptor'}, {'cui': 'C0061352', 'cui_str': 'Glucagon Receptor'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}]","[{'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0700364', 'cui_str': 'Appearances (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C2347023', 'cui_str': 'Absorption'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C0439834', 'cui_str': 'Slowly'}]",,0.0872167,"After 28 days of treatment, SAR425899 improved postprandial glucose control by significantly enhancing β-cell function and slowing glucose absorption rate.","[{'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Visentin', 'Affiliation': 'Department of Information Engineering, University of Padova, Padova, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Schiavon', 'Affiliation': 'Department of Information Engineering, University of Padova, Padova, Italy.'}, {'ForeName': 'Britta', 'Initials': 'B', 'LastName': 'Göbel', 'Affiliation': 'Sanofi-Aventis Deutschland GmbH, Frankfurt am Main, Germany.'}, {'ForeName': 'Michela', 'Initials': 'M', 'LastName': 'Riz', 'Affiliation': 'Sanofi-Aventis Deutschland GmbH, Frankfurt am Main, Germany.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Cobelli', 'Affiliation': 'Department of Information Engineering, University of Padova, Padova, Italy.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Klabunde', 'Affiliation': 'Sanofi-Aventis Deutschland GmbH, Frankfurt am Main, Germany.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Dalla Man', 'Affiliation': 'Department of Information Engineering, University of Padova, Padova, Italy.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13939']
750,31714396,The Effect and Safety of Aerobic Interval Training According to Exercise Intensity in Acute Coronary Syndrome.,"PURPOSE


To evaluate the effect of increasing the maximal oxygen uptake ((Equation is included in full-text article.)O2max) and the safety of maximal-intensity aerobic interval training (MAIT) compared with high-intensity aerobic interval training (HAIT).
METHODS


Forty-seven patients with first-ever acute coronary syndrome were assigned to MAIT or HAIT. Subjects underwent adaptation period during the first 2 wk of cardiac rehabilitation and then MAIT at 95-100% of the heart rate reserve or HAIT at 85% of the heart rate reserve, 3 d/wk for 4 wk. The primary outcome was (Equation is included in full-text article.)O2max. The secondary outcomes were major cardiovascular complications, hemodynamic responses, myocardial oxygen demand, cardiometabolic health, and echocardiographic findings.
RESULTS


A total of 670.5 hr of MAIT and HAIT were completed. After 6 wk of aerobic interval training, (Equation is included in full-text article.)O2max was significantly increased in both groups. However, the increment of (Equation is included in full-text article.)O2max was significantly greater in the MAIT group than in the HAIT group (P < .05). The percentage increases for MAIT and HAIT were 31% and 17%, respectively. No major cardiovascular or musculoskeletal complications were noted.
CONCLUSIONS


The results of this study indicate that 6 wk of MAIT resulted in statistically significantly better improvement in (Equation is included in full-text article.)O2max than 6 wk of HAIT at a similar total work in patients with acute coronary syndrome. Moreover, both MAIT and HAIT may be safe to use in the cardiac rehabilitation setting.",2020,"No major cardiovascular or musculoskeletal complications were noted.
","['Forty-seven patients with first-ever acute coronary syndrome', 'Acute Coronary Syndrome', 'patients with acute coronary syndrome']","['MAIT and HAIT', 'MAIT', 'high-intensity aerobic interval training (HAIT', 'maximal-intensity aerobic interval training (MAIT', 'MAIT or HAIT', 'HAIT', 'Aerobic Interval Training']","['MAIT and HAIT', 'maximal oxygen uptake (VO2max', 'VO2max', 'major cardiovascular complications, hemodynamic responses, myocardial oxygen demand, cardiometabolic health, and echocardiographic findings', 'major cardiovascular or musculoskeletal complications', 'increment of VO2max']","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake (observable entity)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C2607943', 'cui_str': 'findings'}]",47.0,0.0803051,"No major cardiovascular or musculoskeletal complications were noted.
","[{'ForeName': 'Chul', 'Initials': 'C', 'LastName': 'Kim', 'Affiliation': 'Department of Rehabilitation Medicine, Sanggye Paik Hospital, Inje University College of Medicine, Seoul, Korea (Dr Kim); and Department of Rehabilitation Medicine, Haeundae Paik Hospital, Inje University College of Medicine, Busan, Korea (Dr Choi).'}, {'ForeName': 'Hee Eun', 'Initials': 'HE', 'LastName': 'Choi', 'Affiliation': ''}]",Journal of cardiopulmonary rehabilitation and prevention,['10.1097/HCR.0000000000000455']
751,30947606,RETRACTED: A randomized comparison of ultrasound-guided versus landmark-based corticosteroid injection for trigger finger.,,2020,No significant differences between the two groups were observed in pain or QuickDASH scores at 24 weeks of follow-up.,['One hundred and four patients who had been diagnosed with trigger finger and were to be treated by corticosteroid injection'],"['Ultrasound-guided steroid injection', 'landmark-based injection and the other for ultrasound-guided injection', 'ultrasound-guided versus landmark-based corticosteroid injection']","['pain or QuickDASH scores', 'adverse events', 'visual analogue scale score for pain and the Quick Disability of the Arm, Shoulder, and Hand (QuickDASH) score']","[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0158328', 'cui_str': 'Trigger Digits'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C4305575', 'cui_str': 'Ultrasonography guided steroid injection'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0018563', 'cui_str': 'Hand'}]",,0.0500322,No significant differences between the two groups were observed in pain or QuickDASH scores at 24 weeks of follow-up.,"[{'ForeName': 'Young Hak', 'Initials': 'YH', 'LastName': 'Roh', 'Affiliation': 'Department of Orthopaedic Surgery, Ewha Womans University Medical Center, Ewha Womans University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Sangwoo', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Department of Orthopaedic Surgery, Ewha Womans University Medical Center, Ewha Womans University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Hyun Sik', 'Initials': 'HS', 'LastName': 'Gong', 'Affiliation': 'Department of Orthopaedic Surgery, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Sungnam, South Korea.'}, {'ForeName': 'Goo Hyun', 'Initials': 'GH', 'LastName': 'Baek', 'Affiliation': 'Department of Orthopaedic Surgery, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, South Korea.'}]","The Journal of hand surgery, European volume",['10.1177/1753193419839892']
752,29912571,Effect of a Home-Based Lifestyle Intervention on Breastfeeding Initiation Among Socioeconomically Disadvantaged African American Women with Overweight or Obesity.,"BACKGROUND


Socioeconomically disadvantaged (SED) African American women with overweight or obesity are less likely to breastfeed.
OBJECTIVE


To test whether a home-based lifestyle intervention impacts breastfeeding initiation rates in SED African American women with overweight or obesity.
STUDY DESIGN


This was a secondary analysis of a randomized controlled trial from October 2012 to March 2016 at a university-based hospital within the LIFE-Moms consortium. SED African American women with overweight or obesity and singleton gestations were randomized by 16 weeks to Parents as Teachers (PAT)-a home-based parenting support and child development educational intervention-or PAT+, PAT with additional content on breastfeeding. Participants completed a breastfeeding survey. Outcomes included breastfeeding initiation and reasons for not initiating or not continuing breastfeeding.
RESULTS


One hundred eighteen women were included: 59 in PAT+; 59 in PAT. Breastfeeding initiation rates were similar in each group (78.00% in PAT+; 74.58% in PAT). On a one to four scale, with four denoting ""very important,"" women in PAT+ and PAT were equally likely to rate their beliefs that formula was better than breast milk or breastfeeding would be too inconvenient as the most important reasons to not initiate breastfeeding. On the same scale, women similarly rated their difficulty latching or concern for low milk supply as the most important reasons for breastfeeding cessation.
CONCLUSION


SED African American women with overweight or obesity who received a home-based educational intervention had higher breastfeeding rates than is reported nationally for black women (59%). However, the intervention with more breastfeeding content did not further increase breastfeeding rates or impact reasons for breastfeeding cessation.
TRIAL REGISTRATION


ClinicalTrials.gov : NCT01768793.",2018,Breastfeeding initiation rates were similar in each group (78.00% in PAT+; 74.58% in PAT).,"['SED African American women with overweight or obesity', 'Socioeconomically Disadvantaged African American Women with Overweight or Obesity', 'Socioeconomically disadvantaged (SED) African American women with overweight or obesity', 'One hundred eighteen women were included: 59 in PAT+; 59 in PAT', 'October 2012 to March 2016 at a university-based hospital within the LIFE-Moms consortium', 'SED African American women with overweight or obesity and singleton gestations', 'SED African American women with overweight or obesity who received a']","['home-based educational intervention', 'Teachers (PAT)-a home-based parenting support and child development educational intervention-or PAT+, PAT with additional content on breastfeeding', 'home-based lifestyle intervention', 'Home-Based Lifestyle Intervention']","['breastfeeding initiation and reasons for not initiating or not continuing breastfeeding', 'Breastfeeding Initiation', 'Breastfeeding initiation rates', 'breastfeeding rates']","[{'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0030587', 'cui_str': 'Paroxysmal atrial tachycardia (disorder)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C1442163', 'cui_str': 'Multiple of the median'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0008071', 'cui_str': 'Child Development'}, {'cui': 'C0030587', 'cui_str': 'Paroxysmal atrial tachycardia (disorder)'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}]","[{'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C0392360', 'cui_str': 'Reason for (attribute)'}]",118.0,0.0556056,Breastfeeding initiation rates were similar in each group (78.00% in PAT+; 74.58% in PAT).,"[{'ForeName': 'Adam K', 'Initials': 'AK', 'LastName': 'Lewkowitz', 'Affiliation': '1 Department of Obstetrics and Gynecology, Washington University in St. Louis , St. Louis, Missouri.'}, {'ForeName': 'Julia D', 'Initials': 'JD', 'LastName': 'López', 'Affiliation': '1 Department of Obstetrics and Gynecology, Washington University in St. Louis , St. Louis, Missouri.'}, {'ForeName': 'Richard I', 'Initials': 'RI', 'LastName': 'Stein', 'Affiliation': '2 Center for Human Nutrition, Washington University in St. Louis , St. Louis, Missouri.'}, {'ForeName': 'Janine S', 'Initials': 'JS', 'LastName': 'Rhoades', 'Affiliation': '1 Department of Obstetrics and Gynecology, Washington University in St. Louis , St. Louis, Missouri.'}, {'ForeName': 'Rosa C', 'Initials': 'RC', 'LastName': 'Schulz', 'Affiliation': '1 Department of Obstetrics and Gynecology, Washington University in St. Louis , St. Louis, Missouri.'}, {'ForeName': 'Candice L', 'Initials': 'CL', 'LastName': 'Woolfolk', 'Affiliation': '1 Department of Obstetrics and Gynecology, Washington University in St. Louis , St. Louis, Missouri.'}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Macones', 'Affiliation': '1 Department of Obstetrics and Gynecology, Washington University in St. Louis , St. Louis, Missouri.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Haire-Joshu', 'Affiliation': '3 School of Public Health and Medicine, Washington University in St. Louis , St. Louis, Missouri.'}, {'ForeName': 'Alison G', 'Initials': 'AG', 'LastName': 'Cahill', 'Affiliation': '1 Department of Obstetrics and Gynecology, Washington University in St. Louis , St. Louis, Missouri.'}]",Breastfeeding medicine : the official journal of the Academy of Breastfeeding Medicine,['10.1089/bfm.2018.0006']
753,31713753,Transcranial direct current stimulation improves the swallowing function in patients with cricopharyngeal muscle dysfunction following a brainstem stroke.,"OBJECTIVE


This study investigated the effects of transcranial direct current stimulation (tDCS) combined with conventional swallowing training on the swallowing function in brainstem stroke patients with cricopharyngeal muscle dysfunction (CPD).
METHODS


Twenty-eight brainstem stroke patients with CPD were assigned randomly to an anodal tDCS group or a sham tDCS group. The patients received anodal tDCS or sham tDCS over the bilateral oesophageal cortical area combined with simultaneous catheter balloon dilatation and conventional swallowing therapy for 20 days. Swallowing function was assessed using the functional oral intake scale (FOIS) and the functional dysphagia scale (FDS) and by measuring the pharyngoesophageal Segment Opening (PESO) before and immediately after the intervention.
RESULTS


Both groups showed a significant improvement in the FDS, FOIS and PESO scores immediately after the intervention (all p < .005). However, compared with the sham stimulation group, the anodal tDCS group showed greater improvements in the FDS, FOIS and PESO scores immediately after the intervention (all p < .005).
CONCLUSION


The bihemispheric anodal tDCS combined with simultaneous catheter balloon dilatation and conventional swallowing therapy effectively improves the swallowing function in patients with CPD caused by a brainstem stroke. tDCS may be an effective adjuvant therapy in CPD rehabilitation.",2020,"Both groups showed a significant improvement in the FDS, FOIS and PESO scores immediately after the intervention (all p < .005).","['brainstem stroke patients with cricopharyngeal muscle dysfunction (CPD', 'patients with CPD caused by a brainstem stroke', 'Twenty-eight brainstem stroke patients with CPD', 'patients with cricopharyngeal muscle dysfunction following a brainstem stroke']","['bihemispheric anodal tDCS combined with simultaneous catheter balloon dilatation and conventional swallowing therapy', 'tDCS', 'anodal tDCS', 'anodal tDCS or sham tDCS', 'Transcranial direct current stimulation', 'bilateral oesophageal cortical area combined with simultaneous catheter balloon dilatation and conventional swallowing therapy', 'anodal tDCS group or a sham tDCS', 'transcranial direct current stimulation (tDCS) combined with conventional swallowing training']","['FDS, FOIS and PESO scores', 'swallowing function', 'Swallowing function', 'functional oral intake scale (FOIS) and the functional dysphagia scale (FDS) and by measuring the pharyngoesophageal Segment Opening (PESO']","[{'cui': 'C0521542', 'cui_str': 'Brainstem Stroke'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}, {'cui': 'C2001794', 'cui_str': '(BMIM)(TFSI) cpd'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft (physical object)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0011167', 'cui_str': 'Swallowing'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0326374', 'cui_str': 'Swallows'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0222045'}, {'cui': 'C4302242', 'cui_str': 'Functional dysphagia'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0441635', 'cui_str': 'Segment (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}]",,0.0176615,"Both groups showed a significant improvement in the FDS, FOIS and PESO scores immediately after the intervention (all p < .005).","[{'ForeName': 'Zhi-Yong', 'Initials': 'ZY', 'LastName': 'Wang', 'Affiliation': 'Department of Rehabilitation Medicine, The First Affiliated Hospital of Fujian Medical University, 20 Chazhong Road, Fuzhou, 350005, China.'}, {'ForeName': 'Jian-Min', 'Initials': 'JM', 'LastName': 'Chen', 'Affiliation': 'Department of Rehabilitation Medicine, The First Affiliated Hospital of Fujian Medical University, 20 Chazhong Road, Fuzhou, 350005, China.'}, {'ForeName': 'Zheng-Kun', 'Initials': 'ZK', 'LastName': 'Lin', 'Affiliation': 'Department of Rehabilitation Medicine, The 909th Hospital, 269 Zhanghua Middle Road, Zhangzhou, 363000, China.'}, {'ForeName': 'Guo-Xin', 'Initials': 'GX', 'LastName': 'Ni', 'Affiliation': 'Department of Rehabilitation Medicine, The First Affiliated Hospital of Fujian Medical University, 20 Chazhong Road, Fuzhou, 350005, China. guoxinni@fjmu.edu.cn.'}]",Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology,['10.1007/s10072-019-04120-x']
754,30927200,Aerobic exercise increases hippocampal subfield volumes in younger adults and prevents volume decline in the elderly.,"Exercise improves both physical and mental health and increases neurogenesis in the dendate gyrus (DG) of the hippocampus. The aim of this study was to examine whether exercising, as compared to no change in regular physical activity, would impact on hippocampal volume, and in particular the core hippocampal structures, DG and cornu ammonis (CA) subfields, and whether any changes would be moderated by age. Thirty nine previously sedentary healthy participants were randomized to either a standardized progressive aerobic exercise program or to ""no change"" for 16 weeks. Mental health including profile of mood states (POMS), was assessed before and every 4 weeks during the program. Magnetic resonance imaging to examine hippocampal subfields was carried out before and after the program. Aerobic exercise resulted in a significant improvement of the POMS item 'vigour' compared to those in the control group. Overall left hippocampal and left CA4-DG volumes increased significantly in the exercise group while no significant changes were seen in the control group. Older adults in the control group demonstrated significant reductions in CA4-DG subfields over the study, whereas older adults in the exercise group did not show volume decline. These findings reinforce the literature that exercise has a beneficial effect on mental health and can prevent age-related volume decline. Exercise to Improve Resilience, https://register.clinicaltrials.gov/prs/app/action/LoginUser?ts=1&cx=-jg9qo4 , NCT02541136, Rec Ref 2011/45/13.",2020,Aerobic exercise resulted in a significant improvement of the POMS item 'vigour' compared to those in the control group.,"['Thirty nine previously sedentary healthy participants', 'Older adults', 'younger adults']","['Magnetic resonance imaging', 'Exercise', 'standardized progressive aerobic exercise program or to ""no change"" for 16\xa0weeks', 'Aerobic exercise']","[""POMS item 'vigour"", 'physical and mental health', 'Mental health including profile of mood states (POMS', 'hippocampal subfield volumes', 'CA4-DG subfields', 'Overall left hippocampal and left CA4-DG volumes']","[{'cui': 'C3816447', 'cui_str': '39 (qualifier value)'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0442739', 'cui_str': 'Id status quo'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0451394', 'cui_str': 'Profile of mood states (assessment scale)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}]",39.0,0.0545106,Aerobic exercise resulted in a significant improvement of the POMS item 'vigour' compared to those in the control group.,"[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Frodl', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Otto von Guericke University Magdeburg, Leipzigerstr. 44, 39120, Magdeburg, Germany. thomas.frodl@med.ovgu.de.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Strehl', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Regensburg, Regensburg, Germany.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Carballedo', 'Affiliation': 'Department of Psychiatry and Trinity College Institute of Neuroscience, Trinity College Dublin, College Green, Dublin, 2, Ireland.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Tozzi', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Otto von Guericke University Magdeburg, Leipzigerstr. 44, 39120, Magdeburg, Germany.'}, {'ForeName': 'Myles', 'Initials': 'M', 'LastName': 'Doyle', 'Affiliation': 'Department of Psychiatry and Trinity College Institute of Neuroscience, Trinity College Dublin, College Green, Dublin, 2, Ireland.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Amico', 'Affiliation': 'Department of Psychiatry and Trinity College Institute of Neuroscience, Trinity College Dublin, College Green, Dublin, 2, Ireland.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Gormley', 'Affiliation': ""Department of Physiotherapy, St. James's Hospital, Trinity College Dublin, James's Street, Dublin, 8, Ireland.""}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Lavelle', 'Affiliation': ""Department of Physiotherapy, St. James's Hospital, Trinity College Dublin, James's Street, Dublin, 8, Ireland.""}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': ""O'Keane"", 'Affiliation': 'Department of Psychiatry and Trinity College Institute of Neuroscience, Trinity College Dublin, College Green, Dublin, 2, Ireland.'}]",Brain imaging and behavior,['10.1007/s11682-019-00088-6']
755,30930133,"Regular insulin added to total parenteral nutrition vs subcutaneous glargine in non-critically ill diabetic inpatients, a multicenter randomized clinical trial: INSUPAR trial.","BACKGROUND


There is no established insulin regimen in T2DM patients receiving parenteral nutrition.
AIMS


To compare the effectiveness (metabolic control) and safety of two insulin regimens in patients with diabetes receiving TPN.
DESIGN


Prospective, open-label, multicenter, clinical trial on adult inpatients with type 2 diabetes on a non-critical setting with indication for TPN. Patients were randomized on one of these two regimens: 100% of RI on TPN or 50% of Regular insulin added to TPN bag and 50% subcutaneous GI. Data were analyzed according to intention-to-treat principle.
RESULTS


81 patients were on RI and 80 on GI. No differences were observed in neither average total daily dose of insulin, programmed or correction, nor in capillary mean blood glucose during TPN infusion (165.3 ± 35.4 in RI vs 172.5 ± 43.6 mg/dL in GI; p = 0.25). Mean capillary glucose was significantly lower in the GI group within two days after TPN interruption (160.3 ± 45.1 in RI vs 141.7 ± 43.8 mg/dL in GI; p = 0.024). The percentage of capillary glucose above 180 mg/dL was similar in both groups. The rate of capillary glucose ≤70 mg/dL, the number of hypoglycemic episodes per 100 days of TPN, and the percentage of patients with non-severe hypoglycemia were significantly higher on GI group. No severe hypoglycemia was detected. No differences were observed in length of stay, infectious complications, or hospital mortality.
CONCLUSION


Effectiveness of both regimens was similar. GI group achieved better metabolic control after TPN interruption but non-severe hypoglycemia rate was higher in the GI group.
CLINICAL TRIAL REGISTRY


This trial is registered at clinicaltrials.gov as NCT02706119.",2020,"No differences were observed in neither average total daily dose of insulin, programmed or correction, nor in capillary mean blood glucose during TPN infusion (165.3 ± 35.4 in RI vs 172.5 ± 43.6 mg/dL in GI; p = 0.25).","['T2DM patients receiving parenteral nutrition', '81 patients were on RI and 80 on GI', 'non-critically ill diabetic inpatients', 'patients with diabetes receiving TPN', 'adult inpatients with type 2 diabetes on a non-critical setting with indication for TPN']","['Regular insulin added to total parenteral nutrition vs subcutaneous glargine', 'RI on TPN or 50% of Regular insulin added to TPN bag and 50% subcutaneous GI']","['percentage of capillary glucose', 'number of hypoglycemic episodes', 'average total daily dose of insulin, programmed or correction, nor in capillary mean blood glucose', 'rate of capillary glucose', 'percentage of patients with non-severe hypoglycemia', 'metabolic control', 'severe hypoglycemia', 'severe hypoglycemia rate', 'Mean capillary glucose', 'length of stay, infectious complications, or hospital mortality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030547', 'cui_str': 'Parenteral Nutrition'}, {'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0030548', 'cui_str': 'Parenteral Hyperalimentation'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0392360', 'cui_str': 'Reason for (attribute)'}]","[{'cui': 'C0021641', 'cui_str': 'Insulin, Regular'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0030548', 'cui_str': 'Parenteral Hyperalimentation'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C1706249', 'cui_str': 'Bag - unit of product usage (qualifier value)'}]","[{'cui': 'C0006901', 'cui_str': 'Capillaries'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0745153', 'cui_str': 'Hypoglycemic attack'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0085556', 'cui_str': 'Mortalities, In-house'}]",81.0,0.0732609,"No differences were observed in neither average total daily dose of insulin, programmed or correction, nor in capillary mean blood glucose during TPN infusion (165.3 ± 35.4 in RI vs 172.5 ± 43.6 mg/dL in GI; p = 0.25).","[{'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Olveira', 'Affiliation': 'Unidad de Gestión Clínica de Endocrinología y Nutrición, Hospital Regional Universitario de Málaga, Instituto de Investigación Biomédica de Málaga (IBIMA), Spain; Universidad de Málaga, Spain; CIBERDEM (CB07/08/0019), Instituto de Salud Carlos III, Madrid, Spain. Electronic address: gabrielm.olveira.sspa@juntadeandalucia.es.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Abuín', 'Affiliation': 'Unidad de Gestión Clínica de Endocrinología y Nutrición, Hospital Regional Universitario de Málaga, Instituto de Investigación Biomédica de Málaga (IBIMA), Spain; Universidad de Málaga, Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'López', 'Affiliation': ""Servicio de Endocrinología y Nutrición, Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat (Barcelona), Spain.""}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Herranz', 'Affiliation': 'Servicio de Endocrinología y Nutrición, Hospital Universitario de Guadalajara, Guadalajara, Spain.'}, {'ForeName': 'Jose M', 'Initials': 'JM', 'LastName': 'García-Almeida', 'Affiliation': 'Servicio de Endocrinología y Nutrición, Hospital Universitario Virgen de la Victoria, Málaga, Spain.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'García-Malpartida', 'Affiliation': 'Servicio de Endocrinología y Nutrición, Hospital Universitario y Politécnico La Fe, Valencia, Spain.'}, {'ForeName': 'Mercedes', 'Initials': 'M', 'LastName': 'Ferrer', 'Affiliation': 'Servicio de Endocrinología y Nutrición, Hospital Clínico Universitario Virgen de la Arrixaca, Murcia, Spain.'}, {'ForeName': 'Emilia', 'Initials': 'E', 'LastName': 'Cancer', 'Affiliation': 'Sección de Endocrinología y Nutrición, Hospital Universitario de Fuenlabrada, Madrid, Spain.'}, {'ForeName': 'Luis M', 'Initials': 'LM', 'LastName': 'Luengo-Pérez', 'Affiliation': 'Servicio de Endocrinología y Nutrición, Hospital Universitario de Badajoz, Badajoz, Spain.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Álvarez', 'Affiliation': 'Servicio de Endocrinología y Nutrición, Hospital Universitario Príncipe de Asturias, Madrid, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Aragón', 'Affiliation': 'Servicio de Endocrinología y Nutrición, Hospital Universitario Fundación Jiménez Díaz, Madrid, Spain.'}, {'ForeName': 'María J', 'Initials': 'MJ', 'LastName': 'Ocón', 'Affiliation': 'Servicio de Endocrinología y Nutrición, Hospital Universitario Lozano Blesa, Zaragoza, Spain.'}, {'ForeName': 'Álvaro', 'Initials': 'Á', 'LastName': 'García-Manzanares', 'Affiliation': 'Servicio de Endocrinología y Nutrición, Hospital General La Mancha Centro, Alcázar de San Juan, Spain.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Bretón', 'Affiliation': 'Servicio de Endocrinología y Nutrición, Hospital Universitario Gregorio Marañón, Madrid, Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Serrano-Aguayo', 'Affiliation': 'Unidad de Endocrinología y Nutrición, Hospital Universitario Virgen del Rocío, Sevilla, Spain.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Pérez-Ferre', 'Affiliation': 'Servicio de Endocrinología y Nutrición, Hospital Clínico San Carlos, Madrid, Spain.'}, {'ForeName': 'Juan J', 'Initials': 'JJ', 'LastName': 'López-Gómez', 'Affiliation': 'Servicio de Endocrinología y Nutrición, Hospital Clínico Universitario de Valladolid, Valladolid, Spain.'}, {'ForeName': 'Josefina', 'Initials': 'J', 'LastName': 'Olivares', 'Affiliation': 'Servicio de Endocrinología y Nutrición, Hospital Universitario Son Llatzer, Illes Balears, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Arraiza', 'Affiliation': 'Servicio de Endocrinología y Nutrición, Complejo Hospitalario de Jaén, Jaén, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Tejera', 'Affiliation': 'Servicio de Endocrinología y Nutrición, Complejo Hospitalario Universitario de Ferrol, A Coruña, Spain.'}, {'ForeName': 'Jorge D', 'Initials': 'JD', 'LastName': 'Martín', 'Affiliation': 'Servicio de Endocrinología y Nutrición, Hospital Universitario Severo Ochoa, Leganés, Madrid, Spain.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'García', 'Affiliation': 'Servicio de Endocrinología y Nutrición, Complejo Asistencial Universitario de León, León, Spain.'}, {'ForeName': 'Ángel L', 'Initials': 'ÁL', 'LastName': 'Abad', 'Affiliation': 'Unidad de Nutrición - Sección de Endocrinología, Hospital General Universitario de Alicante, Alicante, Spain.'}, {'ForeName': 'María R', 'Initials': 'MR', 'LastName': 'Alhambra', 'Affiliation': 'Servicio de Endocrinología y Nutrición, Hospital Universitario Reina Sofía, Córdoba, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Zugasti', 'Affiliation': 'Servicio de Endocrinología y Nutrición, Complejo Hospitalario de Navarra, Navarra, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Parra', 'Affiliation': 'Servicio de Endocrinología y Nutrición, Hospital de Mérida, Badajoz, Spain.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Torrejón', 'Affiliation': 'Servicio de Endocrinología y Nutrición, Hospital de Sant Joan Despí Moisès Broggi, Barcelona, Spain.'}, {'ForeName': 'María J', 'Initials': 'MJ', 'LastName': 'Tapia', 'Affiliation': 'Unidad de Gestión Clínica de Endocrinología y Nutrición, Hospital Regional Universitario de Málaga, Instituto de Investigación Biomédica de Málaga (IBIMA), Spain.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2019.02.036']
756,30853262,Effects of macronutrient manipulation on postprandial metabolic responses in overweight males with high fasting lipids during simulated shift work: A randomized crossover trial.,"BACKGROUND & AIMS


Meals consumed out of synchronisation with normal circadian rhythms are associated with metabolic dysregulation. Changes in macronutrient composition of meals can improve metabolic responses during the day. Therefore, we aimed to investigate whether macronutrient manipulation of meals alters postprandial glucose and lipid responses and the expression of circadian genes during the night.
METHODS


In a randomised crossover trial, 16 overweight males with high fasting lipids were fed isocaloric meals (2.7 MJ) at 0000 h. The meals differed primarily in total fat and total sugars content (control (8% total sugar, 5% saturated fat) vs test (16% total sugar, 26% saturated fat)). Postprandial blood samples were collected for glucose, insulin (3 h) and triglycerides (6 h) and analysed as incremental area under the curve (iAUC). RNA was extracted at 0 h, 2 h and 4 h and changes in expressions of the circadian genes clock and Per 1-3 analysed.
RESULTS


Postprandial glucose (p = 0.04) and insulin iAUC (p = 0.02) were significantly higher after consumption of the test meal compared to the control meal. Postprandial triglyceride iAUC was not statistically different between the two meal types (p = 0.72). No change in circadian gene expression was observed after the two meals.
CONCLUSIONS


Our results showed that macronutrient composition affects postprandial metabolic response at night. It emphasizes the need to consider the role and effects of night time eating, when developing metabolic disease prevention strategies for shift workers.
STUDY ID NUMBER


ACTRN12618001115224. WEBSITE OF TRIAL REGISTRY: http://www.anzctr.org.au/. Retrospectively registered after data collection.",2020,Postprandial glucose (p = 0.04) and insulin iAUC (p = 0.02) were significantly higher after consumption of the test meal compared to the control meal.,"['overweight males with high fasting lipids during simulated shift work', '16 overweight males with high fasting lipids were fed isocaloric meals (2.7\xa0MJ) at 0000']",['macronutrient manipulation'],"['total fat and total sugars content', 'circadian gene expression', 'insulin iAUC', 'Postprandial triglyceride iAUC', 'glucose, insulin (3\xa0h) and triglycerides (6\xa0h) and analysed as incremental area under the curve (iAUC', 'RNA', 'postprandial metabolic response', 'postprandial metabolic responses', 'metabolic responses', 'Postprandial glucose', 'Postprandial blood samples']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0333051', 'cui_str': 'Shift (morphologic abnormality)'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C2987508', 'cui_str': 'Feeding (observable entity)'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C4517635', 'cui_str': '2.7'}]","[{'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C0947647', 'cui_str': 'Manipulation - action (qualifier value)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0017262', 'cui_str': 'Gene Expression'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0041119', 'cui_str': 'Hydrogen-3'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}]",16.0,0.0731507,Postprandial glucose (p = 0.04) and insulin iAUC (p = 0.02) were significantly higher after consumption of the test meal compared to the control meal.,"[{'ForeName': 'Maxine P', 'Initials': 'MP', 'LastName': 'Bonham', 'Affiliation': 'Department of Nutrition, Dietetics and Food, Monash University, Notting Hill, Victoria, 3168, Australia. Electronic address: maxine.bonham@monash.edu.'}, {'ForeName': 'Elleni', 'Initials': 'E', 'LastName': 'Kaias', 'Affiliation': 'Department of Nutrition, Dietetics and Food, Monash University, Notting Hill, Victoria, 3168, Australia. Electronic address: elleni_kaias@hotmail.com.'}, {'ForeName': 'Catherine E', 'Initials': 'CE', 'LastName': 'Huggins', 'Affiliation': 'Department of Nutrition, Dietetics and Food, Monash University, Notting Hill, Victoria, 3168, Australia. Electronic address: catherine.huggins@monash.edu.'}, {'ForeName': 'Rochelle', 'Initials': 'R', 'LastName': 'Davis', 'Affiliation': 'Department of Nutrition, Dietetics and Food, Monash University, Notting Hill, Victoria, 3168, Australia. Electronic address: rochelle.davis@monash.edu.'}, {'ForeName': 'Gloria Kw', 'Initials': 'GK', 'LastName': 'Leung', 'Affiliation': 'Department of Nutrition, Dietetics and Food, Monash University, Notting Hill, Victoria, 3168, Australia. Electronic address: gloria.leung@monash.edu.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Eikelis', 'Affiliation': 'Iverson Health Innovation Research Institute, Swinburne University of Technology, Hawthorn, Victoria, Australia; Baker Heart and Diabetes Institute, Melbourne, Victoria, Australia. Electronic address: neikelis@swin.edu.au.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Shaw', 'Affiliation': 'Department of Nutrition, Dietetics and Food, Monash University, Notting Hill, Victoria, 3168, Australia. Electronic address: emmacshaw@hotmail.co.uk.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Murgia', 'Affiliation': 'Department of Nutrition, Dietetics and Food, Monash University, Notting Hill, Victoria, 3168, Australia. Electronic address: chiara.murgia@monash.edu.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2019.02.018']
757,31925799,"Effects of tibolone or continuous combined oestradiol and norethisterone acetate on lipids, high-density lipoprotein subfractions and apolipoproteins in postmenopausal women in a two-year, randomized, double-blind, placebo-controlled trial.","OBJECTIVE


To compare the effects of (a) tibolone, (b) continuous combined oestrogen plus progestogen and (c) placebo on plasma lipid and lipoprotein markers of cardiovascular risk in healthy postmenopausal women.
STUDY DESIGN


Randomized, single-centre, placebo-controlled, double-blind study.
PATIENTS


One hundred and one postmenopausal women were randomized (1:1:1) into one of three groups taking daily 2.5 mg tibolone, continuous oral oestradiol-17β 2 mg plus norethisterone acetate 1 mg daily (E 2  /NETA) or placebo.
MAIN OUTCOME MEASURES


Fasting serum lipid, lipoprotein and apolipoprotein concentrations measured at baseline and after 6, 12 and 24 months of treatment.
RESULTS


Both tibolone and E 2  /NETA lowered plasma total cholesterol concentrations relative to placebo. With tibolone, high-density lipoprotein cholesterol (HDL-C) was reduced (-27% at 24 months, P < .001), the greatest effect being in the cholesterol-enriched HDL 2  subfraction (-40%, P < .001). Tibolone's effect on HDL concentrations was also apparent in the principal HDL protein component, apolipoprotein AI (-29% at 24 months, P < .001). However, there was no significant effect of tibolone on low-density or very low-density lipoprotein cholesterol (LDL-C and VLDL-C, respectively). By contrast, the greatest reduction in cholesterol with E 2  /NETA was in LDL-C (-22% at 24 months, P = .008). E 2  /NETA reduced HDL-C to a lesser extent than tibolone (-12% at 24 months, P < .001). Effects on HDL apolipoproteins were similarly diminished relative to tibolone. E 2  /NETA had no effect on VLDL-C or on the protein component of LDL, apolipoprotein B.
CONCLUSION


Tibolone reduces serum HDL. E 2  /NETA reduces LDL cholesterol but not apolipoprotein B, suggesting decreased cholesterol loading of LDL. Any impact these changes may have on CVD risk needs further investigation.",2020,"E 2  /NETA reduced HDL-C to a lesser extent than tibolone (-12% at 24 months, p<0.001).","['healthy post-menopausal women', 'post-menopausal women in a two-year', '101 post-menopausal women']","['tibolone', 'tibolone or continuous combined oestradiol and norethisterone acetate', 'placebo', 'Tibolone', '1) tibolone, 2) continuous combined oestrogen plus progestogen and 3) placebo', 'tibolone, continuous oral oestradiol-17β 2mg plus norethisterone acetate 1mg daily (E 2  /NETA) or placebo']","['serum HDL', 'cholesterol loading of LDL', 'high-density lipoprotein cholesterol (HDL-C', 'Fasting serum lipid, lipoprotein and apolipoprotein concentrations', 'low-density or very-low-density lipoprotein cholesterol', 'plasma total cholesterol concentrations', 'HDL apolipoproteins', 'lipids, HDL subfractions and apolipoproteins', 'plasma lipid and lipoprotein markers of cardiovascular risk', 'LDL cholesterol', 'HDL-C', 'principal HDL protein component, apolipoprotein AI', 'HDL concentrations']","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0076660', 'cui_str': 'tibolone'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0337434', 'cui_str': 'Estradiol measurement (procedure)'}, {'cui': 'C0068980', 'cui_str': 'norethindrone acetate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0202006', 'cui_str': 'Estrogen measurement (procedure)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0033306', 'cui_str': 'Progestins'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0023822', 'cui_str': 'High Density Lipoprotein Cholesterol'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}, {'cui': 'C0523476', 'cui_str': 'Apolipoprotein measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0023826', 'cui_str': 'Pre-beta-Lipoprotein Cholesterol'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1278073', 'cui_str': 'Plasma lipids'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0401925', 'cui_str': 'Teaching principal (occupation)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0085201', 'cui_str': 'Apo AI'}]",101.0,0.372897,"E 2  /NETA reduced HDL-C to a lesser extent than tibolone (-12% at 24 months, p<0.001).","[{'ForeName': 'Payal Trupti', 'Initials': 'PT', 'LastName': 'Kotecha', 'Affiliation': 'Section of Metabolic Medicine, Department of Metabolism, Digestion and Reproduction, Faculty of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Ian F', 'Initials': 'IF', 'LastName': 'Godsland', 'Affiliation': 'Section of Metabolic Medicine, Department of Metabolism, Digestion and Reproduction, Faculty of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Crook', 'Affiliation': 'School of Health Sciences, University of Brighton, Brighton, UK.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Stevenson', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}]",Clinical endocrinology,['10.1111/cen.14155']
758,30879735,Effect of an alcohol-free beer enriched with isomaltulose and a resistant dextrin on insulin resistance in diabetic patients with overweight or obesity.,"BACKGROUND & AIMS


The quality of carbohydrates has an essential role in nutritional management of type 2 diabetes mellitus (T2DM) because of its substantial impact on glucose homeostasis. Alcohol-free beer has beneficial bioactive components but it has a relatively high glycemic-index so its consumption is restricted in diabetic subjects. We aimed to explore the effect of an alcohol-free beer with modified carbohydrate composition almost completely eliminating maltose and adding isomaltulose (16.5 g/day) and a resistant maltodextrin (5.28 g/day) in comparison to a regular alcohol-free beer on glycemic control of diabetic subjects with overweight or obesity.
DESIGN


We randomized 41 subjects into two groups: a) consumption of 66 cL/day of; regular alcohol-free beer for the first 10 weeks and 66 cL/day of alcohol-free beer with modified carbohydrate composition for the next 10 weeks; b) the same described intervention in opposite order. There was a washout period for 6-8 weeks between the two interventions. Participants were counseled to adhere to a healthy diet for cardiovascular health and to increase physical activity. Clinical, biochemical, anthropometric, lifestyle and satiety assessments were performed at the beginning and at the end of each period.
RESULTS


Subjects showed significantly weight loss after the two ten weeks periods (-1.69 ± 3.21% and -1.77 ± 3.70% after experimental and regular alcohol-free beers, respectively, P = 0.881). Glucose and glycated hemoglobin did not significantly change after any period. Insulin concentrations and HOMA-IR significantly decreased (-11.1 [-21.3-4.64]% and -1.92 ± 32.8% respectively) after the intake of experimental alcohol-free beer but not after regular alcohol-free beer. Reductions remained statistically significant after adjusting for weight loss, energy intake, physical activity and intervention order. Subjects reported higher satiety scores after consuming experimental alcohol-free beer.
CONCLUSIONS


An alcohol-free beer including the substitution of regular carbohydrates for low doses of isomaltulose and the addition of a resistant maltodextrin within meals led to an improvement in insulin resistance in subjects with T2DM and overweight or obesity.
CLINICAL TRIAL REGISTRATION


The clinical trial has been registered in ClinicalTrials.gov (Identifier: NCT03337828).",2020,Insulin concentrations and HOMA-IR significantly decreased (-11.1,"['41 subjects into two groups: a', 'diabetic subjects with overweight or obesity', 'diabetic subjects', 'diabetic patients with overweight or obesity', 'subjects with T2DM and overweight or obesity']","['alcohol-free beer with modified carbohydrate composition', 'resistant maltodextrin', 'alcohol-free beer enriched with isomaltulose and a resistant dextrin', 'consumption of 66\xa0cL/day of; regular alcohol-free beer for the first 10 weeks and 66\xa0cL/day of alcohol-free beer with modified carbohydrate composition', 'regular alcohol-free beer']","['weight loss', 'weight loss, energy intake, physical activity and intervention order', 'insulin resistance', 'Clinical, biochemical, anthropometric, lifestyle and satiety assessments', 'Glucose and glycated hemoglobin', 'satiety scores', 'Insulin concentrations and HOMA-IR']","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0004922', 'cui_str': 'Beer'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C0064002', 'cui_str': 'isomaltulose anhydrous'}, {'cui': 'C0054527', 'cui_str': 'caloreen'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0036239', 'cui_str': 'Satiations'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0017853', 'cui_str': 'Hemoglobin, Glycosylated'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}]",41.0,0.0220514,Insulin concentrations and HOMA-IR significantly decreased (-11.1,"[{'ForeName': 'Rocío', 'Initials': 'R', 'LastName': 'Mateo-Gallego', 'Affiliation': 'Hospital Universitario Miguel Servet, Instituto de Investigación Sanitaria Aragón (IIS Aragón), CIBERCV, Zaragoza, Spain; Universidad de Zaragoza, Zaragoza, Spain.'}, {'ForeName': 'Sofía', 'Initials': 'S', 'LastName': 'Pérez-Calahorra', 'Affiliation': 'Hospital Universitario Miguel Servet, Instituto de Investigación Sanitaria Aragón (IIS Aragón), CIBERCV, Zaragoza, Spain.'}, {'ForeName': 'Itziar', 'Initials': 'I', 'LastName': 'Lamiquiz-Moneo', 'Affiliation': 'Hospital Universitario Miguel Servet, Instituto de Investigación Sanitaria Aragón (IIS Aragón), CIBERCV, Zaragoza, Spain. Electronic address: itziarlamiquiz@gmail.com.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Marco-Benedí', 'Affiliation': 'Hospital Universitario Miguel Servet, Instituto de Investigación Sanitaria Aragón (IIS Aragón), CIBERCV, Zaragoza, Spain.'}, {'ForeName': 'Ana M', 'Initials': 'AM', 'LastName': 'Bea', 'Affiliation': 'Hospital Universitario Miguel Servet, Instituto de Investigación Sanitaria Aragón (IIS Aragón), CIBERCV, Zaragoza, Spain.'}, {'ForeName': 'Antonio J', 'Initials': 'AJ', 'LastName': 'Fumanal', 'Affiliation': 'Grupo Ágora - La Zaragozana S.A., Zaragoza, Spain.'}, {'ForeName': 'Ascensión', 'Initials': 'A', 'LastName': 'Prieto-Martín', 'Affiliation': 'Grupo Ágora - La Zaragozana S.A., Zaragoza, Spain.'}, {'ForeName': 'Martín', 'Initials': 'M', 'LastName': 'Laclaustra', 'Affiliation': 'Hospital Universitario Miguel Servet, Instituto de Investigación Sanitaria Aragón (IIS Aragón), CIBERCV, Zaragoza, Spain; Fundación Aragón Investigación y Desarrollo (ARAID), Zaragoza, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Cenarro', 'Affiliation': 'Hospital Universitario Miguel Servet, Instituto de Investigación Sanitaria Aragón (IIS Aragón), CIBERCV, Zaragoza, Spain.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Civeira', 'Affiliation': 'Hospital Universitario Miguel Servet, Instituto de Investigación Sanitaria Aragón (IIS Aragón), CIBERCV, Zaragoza, Spain; Universidad de Zaragoza, Zaragoza, Spain.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2019.02.025']
759,30890001,Effect of withholding feeds on transfusion-related acute gut injury in preterm infants: a pilot randomized controlled trial.,"Background:  Several retrospective studies have reported an increase in necrotizing enterocolitis (NEC) during the 48 h following red blood cell (RBC) transfusion. Whether withholding enteral feeding during transfusion decreases the risk of transfusion-associated acute gut injury (TRAGI) in preterm infants is unclear. Study design and methods:  In this pilot study, 112 preterm infants with gestational age ≤32 weeks and/or birth weight ≤1500 g were randomly assigned to withholding (NPO) or continuance of feeding (FED) during RBC transfusion. Primary outcome measure was development of NEC (stage ≥ 2) within 72 h of a transfusion and the change in abdominal circumference. Results:  One hundred fifty-four transfusion episodes (74 NPO and 80 FED) were analyzed. Demographic characteristics were found to be similar in both groups. There was no difference in rates of NEC (0 versus 3.4%;  p  = .49) between the NPO and FED groups. The incidence of feeding intolerance was higher in the FED group; however, it was statistically insignificant (1.9 versus 6.8%,  p  = .36). Abdominal circumference remained similar in both groups in all three consecutive days following transfusion ( p >.05). Conclusion:  This pilot study does not support withholding feedings during transfusion but is not adequately powered to test the hypothesis that NPO decreases NEC rates. Adequately powered well-designed multicenter trials are still required.",2020,There was no difference in rates of NEC (0 versus 3.4%; p = .49) between the NPO and FED groups.,"['preterm infants', 'One hundred fifty-four transfusion episodes (74 NPO and 80 FED', '112 preterm infants with gestational age ≤32\xa0weeks', 'and/or birth weight ≤1500']","['withholding (NPO) or continuance of feeding (FED', 'withholding feeds']","['development of NEC (stage ≥ 2) within 72\u2009h of a transfusion and the change in abdominal circumference', 'necrotizing enterocolitis (NEC', 'Abdominal circumference', 'incidence of feeding intolerance', 'rates of NEC']","[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4517807', 'cui_str': 'Fifty-four'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}]","[{'cui': 'C2987508', 'cui_str': 'Feeding (observable entity)'}]","[{'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0912341', 'cui_str': ""N'(OB)EC""}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}, {'cui': 'C1300813', 'cui_str': 'Abdominal circumference (observable entity)'}, {'cui': 'C0520459', 'cui_str': 'Necrotizing Enterocolitis'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1820738', 'cui_str': 'Feeding intolerance'}]",112.0,0.312868,There was no difference in rates of NEC (0 versus 3.4%; p = .49) between the NPO and FED groups.,"[{'ForeName': 'Suzan', 'Initials': 'S', 'LastName': 'Sahin', 'Affiliation': 'Department of Neonatology, Zekai Tahir Burak Maternity Teaching Hospital, Ankara, Turkey.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Gozde Kanmaz Kutman', 'Affiliation': 'Department of Neonatology, Zekai Tahir Burak Maternity Teaching Hospital, Ankara, Turkey.'}, {'ForeName': 'Ozlem', 'Initials': 'O', 'LastName': 'Bozkurt', 'Affiliation': 'Department of Neonatology, Zekai Tahir Burak Maternity Teaching Hospital, Ankara, Turkey.'}, {'ForeName': 'Funda', 'Initials': 'F', 'LastName': 'Yavanoglu Atay', 'Affiliation': 'Department of Neonatology, Zekai Tahir Burak Maternity Teaching Hospital, Ankara, Turkey.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Emre Canpolat', 'Affiliation': 'Department of Neonatology, Zekai Tahir Burak Maternity Teaching Hospital, Ankara, Turkey.'}, {'ForeName': 'Nurdan', 'Initials': 'N', 'LastName': 'Uras', 'Affiliation': 'Department of Neonatology, Zekai Tahir Burak Maternity Teaching Hospital, Ankara, Turkey.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Suna Oguz', 'Affiliation': 'Department of Neonatology, Zekai Tahir Burak Maternity Teaching Hospital, Ankara, Turkey.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Underwood', 'Affiliation': ""Davis Children's Hospital, University of California, Sacramento, CA, USA.""}]","The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians",['10.1080/14767058.2019.1597844']
760,29973256,"The caries-arresting effect of incorporating functionalized tricalcium phosphate into fluoride varnish applied following application of silver nitrate solution in preschool children: study protocol for a randomized, double-blind clinical trial.","BACKGROUND


Dental caries in primary teeth is prevalent, affecting millions of children around the world. Functionalized tricalcium phosphate (fTCP) has been incorporated into sodium fluoride (NaF) varnish to enhance the remineralization process. NaF varnish with the adjunctive application of silver nitrate (AgNO 3 ) solution is effective in arresting dentine caries. So far, there is no published randomized clinical trial investigating the effectiveness of the adoption of AgNO 3  solution and NaF varnish containing fTCP in arresting dentine caries in preschool children. The objective of this study is to compare the effectiveness of a 25% AgNO 3  solution plus a 5% NaF varnish containing fTCP and a 25% AgNO 3  solution plus a 5% NaF varnish in arresting coronal dentine caries among preschool children when applied semi-annually over a 30-month period.
METHODS/DESIGN


This is a randomized, double-blind controlled trial. The null hypothesis tested is that no difference exists between the effectiveness of a 25% AgNO 3  solution plus a 5% NaF varnish with fTCP and a 25% AgNO 3  solution plus a 5% NaF varnish in arresting dentine caries in preschool children when applied semi-annually. According to the sample size calculation, approximately 2000 3- to 4-year-old kindergarten children will be screened, and at least 408 children with coronal dentine caries will be recruited. The children will be randomly allocated to two treatment groups via stratified randomization: group A - biannual application of a 25% AgNO 3  solution followed by a 5% NaF varnish, and group B - biannual application of a 25% AgNO 3  solution followed by a 5% NaF varnish with fTCP. Clinical examinations will be conducted every 6 months to assess whether the carious lesions have become arrested (primary outcome). Confounding factors, such as demographic background and oral hygiene behaviors, will be collected through a parental questionnaire.
DISCUSSION


The effectiveness of the topical application of a 25% AgNO 3  solution followed by a 5% NaF varnish with fTCP in arresting coronal dentine caries among preschool children remains unknown. Because the proposed caries-arresting methods are simple, noninvasive and low cost, these can be widely recommended for caries control in young children.
TRIAL REGISTRATION


ClinicalTrials.gov (U.S.): NCT03423797 on 6 February 2018.",2018,NaF varnish with the adjunctive application of silver nitrate (AgNO 3 ) solution is effective in arresting dentine caries.,"['preschool children', 'young children', 'preschool children when applied semi-annually over a 30-month period', '2000 3- to 4-year-old kindergarten children will be screened, and at least 408 children with coronal dentine caries will be recruited']","['25% AgNO 3  solution plus a 5% NaF varnish containing fTCP and a 25% AgNO 3  solution plus a 5% NaF varnish', ' biannual application of a 25% AgNO 3  solution followed by a 5% NaF varnish, and group B - biannual application of a 25% AgNO 3  solution followed by a 5% NaF varnish with fTCP', 'silver nitrate solution', 'functionalized tricalcium phosphate into fluoride varnish', 'sodium fluoride (NaF) varnish', 'silver nitrate (AgNO 3 ) solution', 'Functionalized tricalcium phosphate (fTCP', 'NaF varnish containing fTCP', 'NaF varnish', 'NaF varnish with fTCP']","['dentine caries', 'coronal dentine caries']","[{'cui': 'C0008100', 'cui_str': 'Child, Preschool'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C4517769', 'cui_str': 'Four hundred and eight'}, {'cui': 'C0205123', 'cui_str': 'Coronal (qualifier value)'}, {'cui': 'C0266846', 'cui_str': 'Dental caries extending into dentin'}]","[{'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0042359', 'cui_str': 'Varnish'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0649543', 'cui_str': '4-fluoro-1-(1-(2-thienyl)cyclohexyl)piperidine'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C1321600', 'cui_str': 'Silver nitrate stain'}, {'cui': 'C0108136', 'cui_str': 'tribasic calcium phosphate'}, {'cui': 'C0016326', 'cui_str': 'Fluoride Varnishes'}, {'cui': 'C3652487', 'cui_str': 'sodium fluoride (18F)'}]","[{'cui': 'C0266846', 'cui_str': 'Dental caries extending into dentin'}, {'cui': 'C0205123', 'cui_str': 'Coronal (qualifier value)'}]",,0.549797,NaF varnish with the adjunctive application of silver nitrate (AgNO 3 ) solution is effective in arresting dentine caries.,"[{'ForeName': 'Kitty Jieyi', 'Initials': 'KJ', 'LastName': 'Chen', 'Affiliation': 'Faculty of Dentistry, The University of Hong Kong, Hong Kong SAR, Pokfulam, China.'}, {'ForeName': 'Sherry Shiqian', 'Initials': 'SS', 'LastName': 'Gao', 'Affiliation': 'Faculty of Dentistry, The University of Hong Kong, Hong Kong SAR, Pokfulam, China.'}, {'ForeName': 'Duangporn', 'Initials': 'D', 'LastName': 'Duangthip', 'Affiliation': 'Faculty of Dentistry, The University of Hong Kong, Hong Kong SAR, Pokfulam, China. dduang@hku.hk.'}, {'ForeName': 'Edward Chin Man', 'Initials': 'ECM', 'LastName': 'Lo', 'Affiliation': 'Faculty of Dentistry, The University of Hong Kong, Hong Kong SAR, Pokfulam, China.'}, {'ForeName': 'Chun Hung', 'Initials': 'CH', 'LastName': 'Chu', 'Affiliation': 'Faculty of Dentistry, The University of Hong Kong, Hong Kong SAR, Pokfulam, China.'}]",Trials,['10.1186/s13063-018-2741-1']
761,17675917,[Effects of the association of sulbutiamine with an acetylcholinesterase inhibitor in early stage and moderate Alzheimer disease].,"The efficacy of the inhibitors of acetylcholinesterase in Alzheimer's Disease (AD) is moderated and some patients do not respond to these treatments. Sulbutiamine potentializes cholinergic and glutamatergic transmissions, mainly in hippocampus and prefrontal cortex. This multicentric, randomized and double-blind trial evaluates the effects of the association of sulbutiamine to an anticholinesterasic drug in cognitive functions in patients with AD at an early stage (episodic memory, working memory, executive functions, attention). Patients had first donepezil (D) or sulbutiamine (S) during three months. During this period, only attention improved in both groups. During the three following months, a placebo (P) in patients D and donepezil in patients S were added. Compared to entry results, episodic memory decreased in group D + P but improved in group S + D. At the same time the improvement of attention persisted in both groups. Daylife activities only improved in group S + D. In conclusion sulbutiamine can be an adjuvant to treatment in early stage and moderate AD by anticholinesterasic drugs.",2007,"Compared to entry results, episodic memory decreased in group D + P but improved in group S + D.","['Patients had first donepezil (D) or sulbutiamine (S) during three months', 'patients with AD at an early stage (episodic memory, working memory, executive functions, attention', 'early stage and moderate Alzheimer disease', ""Alzheimer's Disease (AD""]","['sulbutiamine with an acetylcholinesterase inhibitor', 'placebo', 'donepezil']","['episodic memory', 'Daylife activities']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0527316', 'cui_str': 'donepezil'}, {'cui': 'C0075501', 'cui_str': 'sulbutiamine'}, {'cui': 'C4082119', 'cui_str': 'Three months (qualifier value)'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0561843', 'cui_str': 'Autobiographical Memory'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}]","[{'cui': 'C0075501', 'cui_str': 'sulbutiamine'}, {'cui': 'C4521949', 'cui_str': 'Acetylcholinesterase inhibitor (disposition)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0527316', 'cui_str': 'donepezil'}]","[{'cui': 'C0561843', 'cui_str': 'Autobiographical Memory'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",,0.0999169,"Compared to entry results, episodic memory decreased in group D + P but improved in group S + D.","[{'ForeName': 'H', 'Initials': 'H', 'LastName': 'Ollat', 'Affiliation': 'Association pour la Neuro Psycho Pharmacologie, 25 rue de la Plaine, 75020 Paris.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Laurent', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Bakchine', 'Affiliation': ''}, {'ForeName': 'B-F', 'Initials': 'BF', 'LastName': 'Michel', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Touchon', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Dubois', 'Affiliation': ''}]",L'Encephale,[]
762,17675914,[Prescription of olanzapine in children and adolescent psychiatric patients].,"INTRODUCTION


A review of the literature from 1996-2004 on the indications and adverse reactions concerning the use of olanzapine, a second generation antipsychotic agent, in children and adolescents with psychiatric illness is made in this article. Studies lasted for 2 to 3 months and a few had a follow up period up to a year. Olanzapine, dosed from 2.5 to 20 mg/day, is shown to be a useful drug in the treatment of child and adolescent onset schizophrenia, bipolar disorder, anorexia nervosa with delusions, pervasive developmental disorder, tic disorders, and aggression. OPEN AND DOUBLE-BLIND STUDIES: In 4 open labeled studies (26, 34, 39, 43) and 2 case reports (25), 53 patients, aged from 6-18 years old, afflicted by child onset schizophrenia, were treated with olanzapine for 1 1/2 weeks to one year; 19 had treatment resistant childhood schizophrenia and 34 a first episode. In the first group 13/19 showed improvement whereas, in the second group 27/34 were considered responders. Four patients in the first group who had responded to clozapine (stopped because of adverse events) did less well on olanzapine. In 5 studies, 4 open labeled (15, 20, 44) and 1 double blind (27), 59 adolescent onset schizophrenic patients were treated by olanzapine from 8 to 26 weeks; 50/59 patients were considered responders. In the open label study (20) comparing 43 adolescents treated by olanzapine (19 patients), risperidone (17 patients), or haloperidol (7 patients), improvement was significant in the three groups after 4 weeks of treatment and continued after 8 weeks. It is most interesting to mention that 2 months after the end of the study 71% (12/17) of the olanzapine group that had completed the study, 10/15 (67%) of the risperidone group, and 43% (3/7) of the haloperidol group had continued their treatment. Dropouts were for inefficacy and non-compliance in the olanzapine and risperidone groups whereas they were also for adverse events in the haloperidol group (2/4). A final double blind study of 263 adult and adolescent schizophrenic patients (latter are not separated from the former) confirmed the superiority of olanzapine compared to haloperidol and its use for a long period: 67% of the olanzapine and 54% of the haloperidol patients completed the 12-week study.
CASE-REPORTS


12 case reports of children and adolescents diagnosed with acute mania (8, 25, 46, 47) and 23 in an open labeled study (16) were treated by olanzapine; 26/35 were considered to respond well. Some of the patients were on mood stabilizers before adjunction of olanzapine, others on olanzapine monotherapy; 10 case reports of patients with anorexia nervosa associated with psychotic symptomatology, aged from 10-17 years old, relate the use of olanzapine as adjuvant treatment. Improvement was spectacular in these patients who not only gained considerable weight, but were also more compliant to the therapeutic program and their obsessions, delusions, agitation and anxiety became less intense. In this form of anorexia nervosa, olanzapine appears to have an interesting therapeutic role and, in particular, its most important adverse effect, weight gain, became a therapeutic goal. In 2 preliminary studies (24, 30) 31 children and adolescents diagnosed with pervasive developmental disorder were treated by olanzapine from 6 to 13 weeks; 18/25 had good or moderate symptomatic improvement: they were less irritable and hyperactive, and their speech less excessive. In 17 case reports of children and adolescents with aggression (42, 45), associated with tics in 10 patients (49), treatment with olanzapine from 2 weeks to 10 months lowered the presenting symptoms, enhanced the cooperation, and improved the mood of the patients. Only one patient's treatment was changed for inefficacy.
DISCUSSION


No matter what the disorder treated, when olanzapine was compared to haloperidol and risperidone, it proved to be as effective as risperidone, and as or more effective than haloperidol; but when compared to clozapine, it was less effective. The most prominent adverse reaction was excessive weight gain, even more so than in adult patients treated with olanzapine. Also weight gain was greater in children and adolescents treated by olanzapine than those treated by risperidone or haloperidol. Though few treatments had to be interrupted because of this side effect, child and adolescent psychiatrists are wary of the long-term disease related to obesity and glucose dysregulation. All should be done to under-stand the process of weight gain better and to prevent or stall excessive caloric intake, encourage activity, and eventually treat by corrector drugs. Secondly, sedation may bother up to 50% of patients even at the end of the study periods, as many as those treated by haloperidol and more than those treated by risperidone. Extrapyramidal symptoms were mild or moderate compared to those that appear with haloperidol, but may be more frequent than in adult patients. Liver enzymes and blood sugar may be slightly elevated. Prolactemia may be elevated but less so with risperidone and haloperidol.
CONCLUSION


All the authors emphasized the unfortunate lack of randomized double blind studies for the use of olanzapine in this age group.",2007,Also weight gain was greater in children and adolescents treated by olanzapine than those treated by risperidone or haloperidol.,"['children and adolescent psychiatric patients', 'for 1 1/2 weeks to one year; 19 had treatment resistant childhood schizophrenia and 34 a first episode', '43 adolescents treated by', 'In 2 preliminary studies (24, 30) 31 children and adolescents diagnosed with pervasive developmental disorder', 'children and adolescents with psychiatric illness', '59 adolescent onset schizophrenic patients', '12 case reports of children and adolescents diagnosed with acute mania (8, 25, 46, 47) and 23 in an open labeled study (16) were treated by', 'children and adolescents with aggression (42, 45), associated with tics in 10 patients (49), treatment with', 'In 4 open labeled studies (26, 34, 39, 43) and 2 case reports (25), 53 patients, aged from 6-18 years old, afflicted by child onset schizophrenia', 'patients with anorexia nervosa associated with psychotic symptomatology, aged from 10-17 years old', '263 adult and adolescent schizophrenic patients (latter are not separated from the former) confirmed the superiority of']","['olanzapine', 'Olanzapine', 'olanzapine monotherapy', 'clozapine', 'haloperidol', 'risperidone', 'risperidone or haloperidol']","['Extrapyramidal symptoms', 'excessive weight gain', 'Liver enzymes and blood sugar', 'weight gain', 'adverse events', 'inefficacy and non-compliance']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0580272', 'cui_str': '1/2'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0036346', 'cui_str': 'Childhood-Onset Schizophrenia'}, {'cui': 'C0439615', 'cui_str': 'First episode (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0439611', 'cui_str': 'Preliminary (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0524528', 'cui_str': 'Pervasive developmental disorder (disorder)'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0007320', 'cui_str': 'Case Reports'}, {'cui': 'C0235165', 'cui_str': 'Mania acute'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0001807', 'cui_str': 'Aggression'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0278076', 'cui_str': 'Habit Chorea'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0003125', 'cui_str': 'Anorexia Nervosas'}, {'cui': 'C0033975', 'cui_str': 'Psychoses'}, {'cui': 'C4517671', 'cui_str': '263'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}]","[{'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C0009079', 'cui_str': 'Clozapine'}, {'cui': 'C0018546', 'cui_str': 'Haloperidol'}, {'cui': 'C0073393', 'cui_str': 'Risperidone'}]","[{'cui': 'C0234133', 'cui_str': 'Extrapyramidal sign (finding)'}, {'cui': 'C0000765', 'cui_str': 'Excessive weight gain (finding)'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme (substance)'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0457432', 'cui_str': 'Non-compliant (qualifier value)'}]",59.0,0.0173473,Also weight gain was greater in children and adolescents treated by olanzapine than those treated by risperidone or haloperidol.,"[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Frémaux', 'Affiliation': 'CMPP du Gacet, ADPEP 35, 1 allée du Gacet, 35200 Rennes.'}, {'ForeName': 'J-M', 'Initials': 'JM', 'LastName': 'Reymann', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Chevreuil', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Bentué-Ferrer', 'Affiliation': ''}]",L'Encephale,[]
763,30870245,Predictors of Exercise Training and Physical Activity Adherence in People Recently Hospitalized With Heart Failure: A BRIEF REPORT.,"PURPOSE


For individuals with heart failure (HF), frequent attendance at exercise training programs and meeting physical activity (PA) guidelines are significantly associated with improvements in 6-min walk distance. Despite the evidence, adherence to exercise interventions remains poor. The aim of this study was to identify predictors of these 2 variables in patients recently hospitalized with HF.
METHODS


In this substudy of the Exercise Joins Education: Combined Therapy to Improve Outcomes in Newly-discharged Heart Failure (EJECTION-HF) trial, all participants were enrolled in a HF disease management program, including weekly review of a home exercise program for 12 wk. Intervention group participants additionally undertook twice weekly supervised exercise training. Primary outcomes were frequent exercise training program attendance (≥12 sessions) and attainment of PA guidelines (150 min/wk of moderate intensity exercise) at 12 wk. Participant and clinical characteristics were analyzed using a logistic regression model to identify significant predictors of each outcome.
RESULTS


A total of 278 participants provided PA data and 140 contributed attendance data. New diagnosis of HF was a significant predictor of frequent program attendance (OR = 2.3; 95% CI, 1.1-4.7; P = .03). Predictors of meeting PA guidelines at follow-up included new HF diagnosis (OR = 2.4; 95% CI, 1.2-4.8, P = .013), and being physically active at baseline (OR = 2.7; 95% CI, 1.3-5.6; P = .007). Gender, symptom severity, multimorbidity, and disability were not significantly associated with either outcome in multivariate analysis.
CONCLUSION


To improve adherence, specific strategies may be required for patients with decompensated HF and those physically inactive at time of referral.",2019,"New diagnosis of HF was a significant predictor of frequent program attendance (OR = 2.3; 95% CI, 1.1-4.7; P = .03).","['278 participants provided PA data and 140 contributed attendance data', 'Newly-discharged Heart Failure (EJECTION-HF) trial, all participants were enrolled in a HF disease management program, including weekly review of a home exercise program for 12 wk', 'individuals with heart failure (HF', 'patients with decompensated HF and those physically inactive at time of referral', 'People Recently Hospitalized With Heart Failure']","['Exercise Training and Physical Activity Adherence', 'supervised exercise training']","['Gender, symptom severity, multimorbidity, and disability', 'frequent exercise training program attendance (≥12 sessions) and attainment of PA guidelines', 'frequent program attendance']","[{'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0336969', 'cui_str': 'Ejection (qualifier value)'}, {'cui': 'C1303150', 'cui_str': 'Disease management program'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0699752', 'cui_str': 'Review of (contextual qualifier) (qualifier value)'}, {'cui': 'C0475647', 'cui_str': 'Home exercise program (regime/therapy)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C1535889', 'cui_str': 'Multimorbidity'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C2728259', 'cui_str': 'Program'}]",278.0,0.0700865,"New diagnosis of HF was a significant predictor of frequent program attendance (OR = 2.3; 95% CI, 1.1-4.7; P = .03).","[{'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Adsett', 'Affiliation': ""Heart Support Service (Ms Adsett) and Departments of Physiotherapy (Ms Adsett) and Internal Medicine and Aged Care (Dr Mudge), Royal Brisbane and Women's Hospital, Brisbane, Australia; School of Allied Health Sciences, Griffith University, Gold Coast, Australia (Ms Adsett and Dr Morris); Menzies Health Institute, Queensland, Australia (Ms Adsett and Dr Morris); Metro North Hospital and Health Service, The Prince Charles Hospital, Allied Health Research Collaborative, Queensland, Australia (Dr Morris); and University of Queensland Faculty of Medicine, Brisbane, Queensland, Australia (Dr Mudge).""}, {'ForeName': 'Norman R', 'Initials': 'NR', 'LastName': 'Morris', 'Affiliation': ''}, {'ForeName': 'Alison M', 'Initials': 'AM', 'LastName': 'Mudge', 'Affiliation': ''}]",Journal of cardiopulmonary rehabilitation and prevention,['10.1097/HCR.0000000000000407']
764,30418100,Brachial artery intima-media thickness and grayscale texture changes in patients with peripheral artery disease receiving supervised exercise training in the PROPEL randomized clinical trial.,"We performed an exploratory analysis to evaluate the effects of a treadmill exercise program on brachial artery (BA) intima-media thickness (IMT) and three BA grayscale ultrasound measures that may indicate subclinical arterial injury. Data were from a clinical trial in individuals with peripheral artery disease who were randomly assigned to treadmill exercise training or attention control. B-mode ultrasonography was performed at baseline and after 26 weeks. BA IMT, grayscale median (GSM), entropy, and gray-level difference statistic-contrast (GLDS-CON) were measured by a single reader. The 184 participants were (mean (SD)) 66.7 (8.2) years old and had an ankle-brachial index of 0.70 (0.18). Exercise training was associated with a 0.01 (0.06) mm ( p = 0.025) reduction in BA IMT compared to 0.00 (0.05) mm ( p = 0.807) in the control group (between-group p = 0.061). BA GSM, entropy, and GLDS-CON did not change significantly with exercise. Improvements in the 6-minute walk distance correlated with increases in resting BA blood flow ( r = 0.23, p = 0.032), flow-mediated dilation ( r = 0.24, p = 0.022), diameter ( r = 0.29, p = 0.005), entropy ( r = 0.21, p = 0.047), and GLDS-CON ( r = 0.22, p = 0.041). In a post hoc analysis, BA IMT improved significantly with treadmill exercise training but did not change with attention control; however, the between-group difference did not reach statistical significance. With exercise, improvements in the 6-minute walk distance were associated with improved endothelial function, increased resting blood flow, and BA dilation, as well as higher grayscale entropy and GLDS-CON, indicating that lower extremity exercise is associated with salutary changes in upper-extremity arterial wall structure and function. ClinicalTrials.gov Identifier: NCT01408901.",2019,"With exercise, improvements in the 6-minute walk distance were associated with improved endothelial function, increased resting blood flow, and BA dilation, as well as higher grayscale entropy and GLDS-CON, indicating that lower extremity exercise is associated with salutary changes in upper-extremity arterial wall structure and function.","['184 participants were (mean (SD)) 66.7 (8.2) years old and had an ankle-brachial index of 0.70 (0.18', 'patients with peripheral artery disease receiving', 'individuals with peripheral artery disease']","['supervised exercise training', 'Exercise training', 'treadmill exercise training', 'treadmill exercise program', 'Brachial artery intima-media thickness', 'treadmill exercise training or attention control']","['resting BA blood flow', '6-minute walk distance', 'endothelial function, increased resting blood flow, and BA dilation', 'BA IMT, grayscale median (GSM), entropy, and gray-level difference statistic-contrast (GLDS-CON', 'brachial artery (BA) intima-media thickness (IMT', 'flow-mediated dilation', 'BA GSM, entropy, and GLDS-CON', 'BA IMT']","[{'cui': 'C4517616', 'cui_str': 'One hundred and eighty-four'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517843', 'cui_str': '66.7 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1328319', 'cui_str': 'Ankle Brachial Index'}, {'cui': 'C4517433', 'cui_str': '0.18'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Artery Disease'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0006087', 'cui_str': 'Brachial Artery'}, {'cui': 'C0162864', 'cui_str': 'Vascular Intima'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0376522', 'cui_str': 'Entropy'}, {'cui': 'C1269776', 'cui_str': 'Gray'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0600673', 'cui_str': 'Statistics'}, {'cui': 'C0006087', 'cui_str': 'Brachial Artery'}, {'cui': 'C0162864', 'cui_str': 'Vascular Intima'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C0069228', 'cui_str': 'O-(glucuronic acid 2-sulfate)-(1--4)-O-(2,5)-anhydromannitol 6-sulfate'}]",184.0,0.0870121,"With exercise, improvements in the 6-minute walk distance were associated with improved endothelial function, increased resting blood flow, and BA dilation, as well as higher grayscale entropy and GLDS-CON, indicating that lower extremity exercise is associated with salutary changes in upper-extremity arterial wall structure and function.","[{'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Berroug', 'Affiliation': '1 Department of Medicine, Division of Cardiovascular Medicine, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.'}, {'ForeName': 'Claudia E', 'Initials': 'CE', 'LastName': 'Korcarz', 'Affiliation': '1 Department of Medicine, Division of Cardiovascular Medicine, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.'}, {'ForeName': 'Carol Kc', 'Initials': 'CK', 'LastName': 'Mitchell', 'Affiliation': '1 Department of Medicine, Division of Cardiovascular Medicine, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.'}, {'ForeName': 'JoAnne M', 'Initials': 'JM', 'LastName': 'Weber', 'Affiliation': '1 Department of Medicine, Division of Cardiovascular Medicine, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Tian', 'Affiliation': '2 Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Mary M', 'Initials': 'MM', 'LastName': 'McDermott', 'Affiliation': '3 Departments of Medicine and Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'James H', 'Initials': 'JH', 'LastName': 'Stein', 'Affiliation': '1 Department of Medicine, Division of Cardiovascular Medicine, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.'}]","Vascular medicine (London, England)",['10.1177/1358863X18804050']
765,32080823,"Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Alirocumab in Healthy Chinese Subjects: A Randomized, Double-Blind, Placebo-Controlled, Ascending Single-Dose Study.","BACKGROUND


The addition of alirocumab (a fully human monoclonal antibody to proprotein convertase subtilisin/kexin type 9 [PCSK9]) to background statin therapy provides significant incremental low-density lipoprotein cholesterol (LDL-C) lowering and cardiovascular event risk reduction.
OBJECTIVES


Our objectives were to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of single ascending doses of alirocumab in healthy Chinese subjects.
METHODS


In this double-blind, placebo-controlled, phase I study, 35 Chinese subjects (aged 21-45 years) with baseline LDL-C > 100 mg/dL (2.59 mmol/L) were randomized to receive a single 1 mL subcutaneous injection of alirocumab 75, 150, or 300 mg, or placebo, and followed up for ~ 12 weeks.
RESULTS


Treatment-emergent adverse events, most frequently nasal congestion and dry throat, were reported in three of seven or eight subjects in each alirocumab dose group (two of seven in the placebo group). One patient receiving alirocumab 300 mg had a mild local injection-site reaction. No alirocumab recipients demonstrated antidrug antibodies. Maximum alirocumab serum concentrations (6-34 mg/dL) occurred at a median of 3-7 days across the dose groups. Maximum mean LDL-C reductions from baseline were observed on days 8, 15, and 22 with alirocumab 75 (55.3%), 150 (63.7%), and 300 mg (73.7%), respectively. Mean free PCSK9 levels were reduced to below the lower limit of quantification within 4 h of dosing. Total cholesterol, non-high-density lipoprotein cholesterol, and apolipoprotein B were reduced with alirocumab.
CONCLUSIONS


In Chinese subjects, alirocumab 75, 150, and 300 mg was safe and well-tolerated. Pharmacokinetic/pharmacodynamic parameters, including clinically meaningful reductions in LDL-C and other lipids/lipoproteins, were consistent with data from Japanese and Western populations. Clinicaltrials.gov identifier: NCT02979015.",2020,"Total cholesterol, non-high-density lipoprotein cholesterol, and apolipoprotein B were reduced with alirocumab.
","['healthy Chinese subjects', '35 Chinese subjects (aged 21-45\xa0years) with baseline LDL-C\u2009', 'Healthy Chinese Subjects']","['placebo', 'alirocumab', 'alirocumab 75, 150, or 300\xa0mg, or placebo', 'Placebo']","['Maximum mean LDL-C reductions', 'mild local injection-site reaction', 'Maximum alirocumab serum concentrations', 'Mean free PCSK9 levels', 'nasal congestion and dry throat', 'safety, tolerability, pharmacokinetics, and pharmacodynamics', 'Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Alirocumab', 'antidrug antibodies', 'Total cholesterol, non-high-density lipoprotein cholesterol, and apolipoprotein B', 'incremental low-density lipoprotein cholesterol (LDL-C) lowering and cardiovascular event risk reduction', 'safe and well-tolerated']","[{'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3491162', 'cui_str': 'alirocumab'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C4319604', 'cui_str': '300'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0151735', 'cui_str': 'Injection Site Adverse Event'}, {'cui': 'C3491162', 'cui_str': 'alirocumab'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0027424', 'cui_str': 'Nasal congestion (finding)'}, {'cui': 'C0235234', 'cui_str': 'Pharyngeal dryness (finding)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0729627', 'cui_str': 'Non-HDL cholesterol'}, {'cui': 'C0003593', 'cui_str': 'ApoB'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C1273410', 'cui_str': 'Cardiovascular event risk'}]",35.0,0.492798,"Total cholesterol, non-high-density lipoprotein cholesterol, and apolipoprotein B were reduced with alirocumab.
","[{'ForeName': 'Haiyan', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, NHC Key Laboratory of Cardiovascular Molecular Biology and Regulatory Peptides, Peking University Third Hospital, 49 North Garden Road, Haidian Distrct, Beijing, 100191, China. haiyanli1027@hotmail.com.'}, {'ForeName': 'Yudong', 'Initials': 'Y', 'LastName': 'Wei', 'Affiliation': 'Drug Clinical Trial Center, Peking University Third Hospital, 49 North Garden Road, Haidian Distrct, Beijing, 100191, China.'}, {'ForeName': 'Zhenhua', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'Drug Clinical Trial Center, Peking University Third Hospital, 49 North Garden Road, Haidian Distrct, Beijing, 100191, China.'}, {'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Drug Clinical Trial Center, Peking University Third Hospital, 49 North Garden Road, Haidian Distrct, Beijing, 100191, China.'}, {'ForeName': 'Xiuxiu', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Drug Clinical Trial Center, Peking University Third Hospital, 49 North Garden Road, Haidian Distrct, Beijing, 100191, China.'}, {'ForeName': 'Mengmeng', 'Initials': 'M', 'LastName': 'Shuai', 'Affiliation': 'Sanofi, Beijing, China.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Vitse', 'Affiliation': 'Clinical Development R&D, Sanofi, Montpellier, France.'}, {'ForeName': 'Yiwen', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Sanofi, Beijing, China.'}, {'ForeName': 'Marie T', 'Initials': 'MT', 'LastName': 'Baccara-Dinet', 'Affiliation': 'Clinical Development R&D, Sanofi, Montpellier, France.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.'}, {'ForeName': 'Jianyong', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Sanofi R&D, Shanghai, China.'}]","American journal of cardiovascular drugs : drugs, devices, and other interventions",['10.1007/s40256-020-00394-1']
766,31633738,"Effect of the Tailored, Family-Involved Hospital Elder Life Program on Postoperative Delirium and Function in Older Adults: A Randomized Clinical Trial.","Importance


Postoperative delirium (POD) is a common condition for older adults, contributing to their functional decline.
Objective


To investigate the effectiveness of the Tailored, Family-Involved Hospital Elder Life Program (t-HELP) for preventing POD and functional decline in older patients after a noncardiac surgical procedure.
Design, Setting, and Participants


A 2-arm, parallel-group, single-blind, cluster randomized clinical trial was conducted from August 24, 2015, to February 28, 2016, on 6 surgical floors (gastric, colorectal, pancreatic, biliary, thoracic, and thyroid) of West China Hospital in Chengdu, China. Eligible participants (n = 281) admitted to each of the 6 surgical floors were randomized into a nursing unit providing t-HELP (intervention group) or a nursing unit providing usual care (control group). All randomized patients were included in the intention-to-treat analyses for the primary outcome of POD incidence. Statistical analysis was performed from April 3, 2016, to December 30, 2017.
Interventions


In addition to receiving usual care, all participants in the intervention group received the t-HELP protocols, which addressed each patient's risk factor profile. Besides nursing professionals, family members and paid caregivers were involved in the delivery of many of the program interventions.
Main Outcomes and Measures


The primary outcome was the incidence of POD, evaluated with the Confusion Assessment Method. Secondary outcomes included the pattern of functional and cognitive changes (activities of daily living [ADLs], instrumental activities of daily living [IADLs], Short Portable Mental Status Questionnaire [SPMSQ]) from hospital admission to 30 days after discharge, and the length of hospital stay (LOS).
Results


Of the 475 patients screened for eligibility, 281 (171 [60.9%] male, mean [SD] age 74.7 [5.2] years) were enrolled and randomized to receive t-HELP (n = 152) or usual care (n = 129). Postoperative delirium occurred in 4 participants (2.6%) in the intervention group and in 25 (19.4%) in the control group, with a relative risk of 0.14 (95% CI, 0.05-0.38). The number needed to treat to prevent 1 case of POD was 5.9 (95% CI, 4.2-11.1). Participants in the intervention group compared with the control group showed less decline in physical function (median [interquartile range] for ADLs: -5 [-10 to 0] vs -20 [-30 to -10]; P < .001; for IADLs: -2 [-2 to 0] vs -4 [-4 to -2]; P < .001) and cognitive function (for the SPMSQ level: 1 [0.8%] vs 8 [7.0%]; P = .009) at discharge, as well as shorter mean (SD) LOS (12.15 [3.78] days vs 16.41 [4.69] days; P < .001).
Conclusions and Relevance


The findings suggest that t-HELP, with family involvement at its core, is effective in reducing POD for older patients, maintaining or improving their physical and cognitive functions, and shortening the LOS. The results of this t-HELP trial may improve generalizability and increase the implementation of this program.
Trial Registration


Chinese Clinical Trial Registry Identifier: ChiCTR-POR-15006944.",2019,"The findings suggest that t-HELP, with family involvement at its core, is effective in reducing POD for older patients, maintaining or improving their physical and cognitive functions, and shortening the LOS.","['male, mean [SD] age 74.7 [5.2] years', 'Eligible participants (n\u2009=\u2009281) admitted to each of the 6 surgical floors', 'older adults', 'Older Adults', 'older patients after a noncardiac surgical procedure', '475 patients screened for eligibility, 281 (171 [60.9', 'August 24, 2015, to February 28, 2016, on 6 surgical floors (gastric, colorectal, pancreatic, biliary, thoracic, and thyroid) of West China Hospital in Chengdu, China']","['nursing unit providing t-HELP (intervention group) or a nursing unit providing usual care (control group', 'Tailored, Family-Involved Hospital Elder Life Program (t-HELP', 'usual care', 'Tailored, Family-Involved Hospital Elder Life Program']","['pattern of functional and cognitive changes (activities of daily living [ADLs], instrumental activities of daily living [IADLs], Short Portable Mental Status Questionnaire [SPMSQ]) from hospital admission to 30 days after discharge, and the length of hospital stay (LOS', 'physical function', 'Postoperative delirium', 'cognitive function', 'POD incidence', 'incidence of POD, evaluated with the Confusion Assessment Method']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517790', 'cui_str': '5.2 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0016249', 'cui_str': 'Floors'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517786', 'cui_str': '475 (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0040134', 'cui_str': 'thyroid (USP)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C0028678', 'cui_str': 'nursing care'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0331055', 'cui_str': 'Elder Plant'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C1290928', 'cui_str': 'Instrumental activity of daily living (observable entity)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0451291', 'cui_str': 'Mental status questionnaire (assessment scale)'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission (procedure)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1319200', 'cui_str': 'Postoperative confusion'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0009676', 'cui_str': 'Confusional State'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]",475.0,0.130027,"The findings suggest that t-HELP, with family involvement at its core, is effective in reducing POD for older patients, maintaining or improving their physical and cognitive functions, and shortening the LOS.","[{'ForeName': 'Yan-Yan', 'Initials': 'YY', 'LastName': 'Wang', 'Affiliation': 'Department of Geriatrics and National Clinical Research Center for Geriatrics, West China Hospital, Sichuan University, Chengdu, Sichuan Province, China.'}, {'ForeName': 'Ji-Rong', 'Initials': 'JR', 'LastName': 'Yue', 'Affiliation': 'Department of Geriatrics and National Clinical Research Center for Geriatrics, West China Hospital, Sichuan University, Chengdu, Sichuan Province, China.'}, {'ForeName': 'Dong-Mei', 'Initials': 'DM', 'LastName': 'Xie', 'Affiliation': 'Department of Geriatrics and National Clinical Research Center for Geriatrics, West China Hospital, Sichuan University, Chengdu, Sichuan Province, China.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Carter', 'Affiliation': 'School of Nursing, The University of Texas at Austin, Austin.'}, {'ForeName': 'Quan-Lei', 'Initials': 'QL', 'LastName': 'Li', 'Affiliation': 'School of Nursing, The Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Sarah L', 'Initials': 'SL', 'LastName': 'Gartaganis', 'Affiliation': 'Hinda and Arthur Marcus Institute for Aging Research, Hebrew SeniorLife, Boston, \u200eMassachusetts.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Breast Surgery, West China Hospital, Sichuan University, Chengdu, Sichuan Province, China.'}, {'ForeName': 'Sharon K', 'Initials': 'SK', 'LastName': 'Inouye', 'Affiliation': 'Hinda and Arthur Marcus Institute for Aging Research, Hebrew SeniorLife, Boston, \u200eMassachusetts.'}]",JAMA internal medicine,['10.1001/jamainternmed.2019.4446']
767,15223977,Oral magnesium supplementation improves insulin sensitivity in non-diabetic subjects with insulin resistance. A double-blind placebo-controlled randomized trial.,"OBJECTIVE


Although hypomagnesemia reduces insulin sensitivity, benefits of magnesium supplementation to non-diabetic insulin resistant subjects has not been established. Our purpose was to determine whether oral magnesium supplementation with magnesium chloride (MgCl2) 2.5 g daily modify insulin sensitivity in non-diabetic subjects.
MATERIAL AND METHODS


This study was a 3 months randomized double-blind placebo-controlled trial. Apparently healthy subjects were eligible to participate if they had insulin resistance (HOMA-IR index equal or greater than 3.0) and hypomagnesemia (Serum magnesium levels equal or lower than 0.74 mmol/l). Subjects were randomized to receive either, MgCl2 2.5 g daily or placebo by 3-months.
RESULTS


At baseline there were not significant anthropometric or laboratory differences between both groups. At ending of the study, magnesium-supplemented subjects significantly increased their serum magnesium levels (0.61 +/- 0.08 to 0.81 +/- 0.08 mmol/l, p<0.0001) and reduced HOMA-IR index (4.6 +/- 2.8 to 2.6 +/- 1.1, p<0.0001), whereas control subjects did not (0.62 +/- 0.08 to 0.61 +/- 0.08 mmol/l, p=0.063 and 5.2 +/- 1.9 to 5.3 +/- 2.9, p=0.087).
CONCLUSIONS


Oral magnesium supplementation improves insulin sensitivity in hypomagnesemic non-diabetic subjects. Clinical implications of this finding have to be established.",2004,At baseline there were not significant anthropometric or laboratory differences between both groups.,"['hypomagnesemic non-diabetic subjects', 'Apparently healthy subjects were eligible to participate if they had insulin resistance (HOMA-IR index equal or greater than 3.0) and hypomagnesemia (Serum magnesium levels equal or lower than 0.74 mmol/l', 'non-diabetic subjects with insulin resistance', 'non-diabetic subjects']","['magnesium supplementation', 'placebo', 'magnesium chloride (MgCl2', 'MgCl2 2.5 g daily or placebo', 'Oral magnesium supplementation']","['serum magnesium levels', 'insulin sensitivity', 'reduced HOMA-IR index']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0202125', 'cui_str': 'Magnesium measurement, serum (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1532563', 'cui_str': 'umol/mL'}]","[{'cui': 'C1096534', 'cui_str': 'Providing magnesium based on suboptimal food or fluid intake, iatrogenic deficiency or medical diagnosis. (Source: IDNT Reference Manual, edition 4; ISBN #978-0-88091-467-3)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1099586', 'cui_str': 'PDMSMgCl'}, {'cui': 'C0024472', 'cui_str': 'Magnesium Chloride'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0202125', 'cui_str': 'Magnesium measurement, serum (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.540321,At baseline there were not significant anthropometric or laboratory differences between both groups.,"[{'ForeName': 'F', 'Initials': 'F', 'LastName': 'Guerrero-Romero', 'Affiliation': 'Medical Research Unit in Clinical Epidemiology of the Mexican Social Security Institute, and Research Group on Diabetes and Chronic Illnesses, FACP Siqueiros 225 esq./Castañeda, 34000 Durango, Dgo., Mexico. guerrero_romero@hotmail.com'}, {'ForeName': 'H E', 'Initials': 'HE', 'LastName': 'Tamez-Perez', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'González-González', 'Affiliation': ''}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Salinas-Martínez', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Montes-Villarreal', 'Affiliation': ''}, {'ForeName': 'J H', 'Initials': 'JH', 'LastName': 'Treviño-Ortiz', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rodríguez-Morán', 'Affiliation': ''}]",Diabetes & metabolism,['10.1016/S1262-3636(07)70116-7']
768,30797045,"C-reactive protein, Epstein-Barr virus, and cortisol trajectories in refugee and non-refugee youth: Links with stress, mental health, and cognitive function during a randomized controlled trial.","Experiencing childhood adversity has been associated with significant changes in inflammation, cell-mediated immunocompetence, and cortisol secretion. Relatively few studies have examined, longitudinally, alterations to inflammatory processes during adolescence, especially outside Western contexts; none have evaluated biomarker trajectories for at-risk youth in response to a structured behavioral intervention. We conducted a randomized controlled trial evaluating the efficacy of a humanitarian intervention targeting stress-alleviation, with 12-18 year-old Syrian refugees (n = 446) and Jordanian non-refugees (n = 371) living side-by-side in war-affected communities in Jordan. We measured C-reactive protein (CRP), Epstein-Barr virus antibodies (EBV), and hair cortisol concentration (HCC) at three timepoints (pre/post intervention and 11 month follow-up), and assessed three main outcomes (psychosocial stress, mental health, and cognitive function). Using growth mixture models, regressions, and growth curve models, we identified three distinct trajectories for CRP, two for EBV, and three for HCC, and examined their associations with age, gender, BMI, poverty, and trauma. We found associations with BMI for CRP, refugee status for EBV, and BMI and gender with HCC trajectory. In terms of health outcomes, we found associations between rising CRP levels and perceived stress (B =  -2.92, p = .007), and between HCC hypersecretion and insecurity (B = 7.21, p = .017). In terms of responses to the intervention, we observed no differential impacts by CRP or EBV trajectories, unlike HCC. These results suggest that commonly-assayed biomarkers do not associate with health outcomes and respond to targeted interventions in straightforward ways. Our study is the first to examine multiple biomarker trajectories in war-affected adolescents, in order to better evaluate the extent, timing, and malleability of the biological signatures of poverty, conflict, and forced displacement.",2020,"Experiencing childhood adversity has been associated with significant changes in inflammation, cell-mediated immunocompetence, and cortisol secretion.",['12-18\u202fyear-old Syrian refugees (n\u202f=\u202f446) and Jordanian non-refugees (n\u202f=\u202f371) living side-by-side in war-affected communities in Jordan'],['humanitarian intervention'],"['main outcomes (psychosocial stress, mental health, and cognitive function', 'C-reactive protein, Epstein-Barr virus, and cortisol trajectories', 'C-reactive protein (CRP), Epstein-Barr virus antibodies (EBV), and hair cortisol concentration (HCC', 'rising CRP levels and perceived stress', 'HCC hypersecretion and insecurity']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0337819', 'cui_str': 'Syrians (ethnic group)'}, {'cui': 'C0034961', 'cui_str': 'Refugees'}, {'cui': 'C0043027', 'cui_str': 'War'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0022418', 'cui_str': 'Jordan'}]",[],"[{'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0014644', 'cui_str': 'Epstein-Barr Virus'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0236525', 'cui_str': 'Epstein-Barr virus antibody (substance)'}, {'cui': 'C0018494', 'cui_str': 'Hair'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0233497', 'cui_str': 'Insecurity (finding)'}]",,0.0231915,"Experiencing childhood adversity has been associated with significant changes in inflammation, cell-mediated immunocompetence, and cortisol secretion.","[{'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Panter-Brick', 'Affiliation': 'Department of Anthropology, Yale University, New Haven, USA. Electronic address: catherine.panter-brick@yale.edu.'}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Wiley', 'Affiliation': 'Department of Anthropology, Yale University, New Haven, USA.'}, {'ForeName': 'Amelia', 'Initials': 'A', 'LastName': 'Sancilio', 'Affiliation': 'Department of Anthropology, Yale University, New Haven, USA.'}, {'ForeName': 'Rana', 'Initials': 'R', 'LastName': 'Dajani', 'Affiliation': 'Department of Biology and Biotechnology, Hashemite University, Zarqa, Jordan.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Hadfield', 'Affiliation': 'Department of Biological and Experimental Psychology, Queen Mary University of London, UK.'}]","Brain, behavior, and immunity",['10.1016/j.bbi.2019.02.015']
769,29498342,Effects of synbiotic supplementation on metabolic parameters and apelin in women with polycystic ovary syndrome: a randomised double-blind placebo-controlled trial.,"Polycystic ovary syndrome (PCOS) is one of the most common causes of infertility in women of reproductive age. Insulin resistance is a main pathophysiologic feature in these patients. According to some studies, the intake of probiotic bacteria may improve glucose homoeostasis. The aim of this study was to investigate the effect of synbiotics on metabolic parameters and apelin in PCOS patients. This randomised double-blind placebo-controlled trial was conducted on eighty-eight PCOS women aged 19-37 years old. The participants were randomly assigned to two groups receiving (1) synbiotic supplement (n 44), and (2) placebo (n 44) for 12 weeks. Fasting blood samples were taken at baseline and after 12 weeks. The two groups showed no difference in fasting blood sugar (adjusted mean difference: 0·60; 95 % CI -3·80, 5·00, P=0·727), plasma glucose fasting 2-h (adjusted mean difference 2·09; 95 % CI -9·96, 14·15, P=0·134), HbA1c (adjusted mean difference 0·06; 95 % CI -0·09, 0·22, P=0·959), homoeostatic model assessment-insulin resistance (HOMA-IR) (adjusted mean difference: 0·02; 95 % CI -0·99, 1·03, P=0·837), quantitative insulin sensitivity check index (QUICKI) (adjusted mean difference: -0·02; 95 % CI -0·33, 0·29, P=0·940) and C-reactive protein (CRP) (adjusted mean difference: 0·24; 95 % CI -1·61, 2·08, P=0·141) by the end of the intervention. A significant difference was observed in the mean apelin 36 before and after the intervention between synbiotic and placebo groups (adjusted mean difference: -4·05; 95 % CI -7·15, -0·96, P=0·004). A 12-week synbiotic supplementation has no significant beneficial effects on HOMA-IR and CRP in PCOS patients, whereas the level of apelin 36 significantly decreased.",2018,"A significant difference was observed in the mean apelin 36 before and after the intervention between synbiotic and placebo groups (adjusted mean difference: -4·05; 95 % CI -7·15, -0·96, P=0·004).","['women with polycystic ovary syndrome', 'PCOS patients', 'Polycystic ovary syndrome (PCOS', 'women of reproductive age', 'eighty-eight PCOS women aged 19-37 years old']","['synbiotic supplement', 'placebo', 'synbiotic supplementation']","['plasma glucose fasting 2-h', 'quantitative insulin sensitivity check index (QUICKI', 'glucose homoeostasis', 'fasting blood sugar', 'Fasting blood samples', 'C-reactive protein (CRP', 'HOMA-IR and CRP', 'homoeostatic model assessment-insulin resistance (HOMA-IR', 'metabolic parameters and apelin']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0032460', 'cui_str': 'Sclerocystic Ovary Syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517898', 'cui_str': '88 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C2936470', 'cui_str': 'Synbiotics'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0019868', 'cui_str': 'Autoregulation'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C3542402', 'cui_str': 'Apelin'}]",88.0,0.727897,"A significant difference was observed in the mean apelin 36 before and after the intervention between synbiotic and placebo groups (adjusted mean difference: -4·05; 95 % CI -7·15, -0·96, P=0·004).","[{'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Karimi', 'Affiliation': '1Department of Clinical Nutrition,School of Nutritional Sciences and Dietetics,Tehran University of Medical Sciences,no. 44,Hojjatdoost Street,Naderi Avenue,Keshavarz Boulevard,Tehran, 14166-43931,Iran.'}, {'ForeName': 'Ashraf', 'Initials': 'A', 'LastName': 'Moini', 'Affiliation': '2Department of Gynecology and Obstetrics,Roointan-Arash Maternity Hospital,Tehran University of Medical Sciences,Eastern 162th Street,Baghdarnia Avenue,Resalat Highway,Tehranpars,Tehran,16539-15981,Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Yaseri', 'Affiliation': '4Department of Epidemiology and Biostatistics,School of Public Health,Tehran University of Medical Sciences,Poorsina Street,Ghods Street, Enghelab Avenue,Tehran, 14176-13151,Iran.'}, {'ForeName': 'Nooshin', 'Initials': 'N', 'LastName': 'Shirzad', 'Affiliation': '5Endocrinology and Metabolism Research Center,Endocrinology and Metabolism Clinical Sciences Institute,Tehran University of Medical Sciences,Northern Kargar Street, Jalal Al Ahmad Highway, Tehran, 14171-3137,Iran.'}, {'ForeName': 'Mahdi', 'Initials': 'M', 'LastName': 'Sepidarkish', 'Affiliation': '6Department of Epidemiology and Reproductive Health,Reproductive Epidemiology Research Center,Royan Institute for Reproductive Biomedicine,Academic Center for Education,Culture and Research, no. 24,Eastern Hafez Alley,Bani Hashem Street,Resalat Highway,Tehran, 16635-148,Iran.'}, {'ForeName': 'Mojgan', 'Initials': 'M', 'LastName': 'Hossein-Boroujerdi', 'Affiliation': '2Department of Gynecology and Obstetrics,Roointan-Arash Maternity Hospital,Tehran University of Medical Sciences,Eastern 162th Street,Baghdarnia Avenue,Resalat Highway,Tehranpars,Tehran,16539-15981,Iran.'}, {'ForeName': 'Mohammad Javad', 'Initials': 'MJ', 'LastName': 'Hosseinzadeh-Attar', 'Affiliation': '1Department of Clinical Nutrition,School of Nutritional Sciences and Dietetics,Tehran University of Medical Sciences,no. 44,Hojjatdoost Street,Naderi Avenue,Keshavarz Boulevard,Tehran, 14166-43931,Iran.'}]",The British journal of nutrition,['10.1017/S0007114517003920']
770,30808573,"Differences in effect of early enteral nutrition on mortality among ventilated adults with shock requiring low-, medium-, and high-dose noradrenaline: A propensity-matched analysis.","BACKGROUND & AIMS


Despite extensive research on early enteral nutrition (EEN), it remains unclear whether EEN is effective for patients with shock requiring vasopressors. This study aimed to compare outcomes between EEN and late enteral nutrition (LEN) in ventilated patients with shock requiring low-, medium-, or high-dose noradrenaline.
METHODS


Using a national inpatient database in Japan, we identified ventilated patients admitted to intensive care units who had shock requiring catecholamines (noradrenaline or dobutamine) from July 2010 to March 2016. We defined patients who started enteral nutrition within 2 days after starting mechanical ventilation as EEN group and the others as LEN group. Propensity score matching was performed between patients undergoing EEN and LEN in each of the low- (<0.1 μg/kg/min), medium- (0.1-0.3 μg/kg/min), and high-dose (≥0.3 μg/kg/min) noradrenaline groups.
RESULTS


We identified 52,563 eligible patients during the 69-month study period, including 38,488, 11,042, and 3033 patients in the low-, medium-, and high-dose noradrenaline groups, respectively. One-to-two propensity score matching created 5,969, 2,162, and 477 one-to-two matched pairs in the low-, medium-, and high-dose noradrenaline groups, respectively. The 28-day mortality rate was significantly lower in the EEN than LEN group in the low-dose noradrenaline group (risk difference, -2.9%; 95% confidence interval [CI], -4.5% to -1.3%) and in the medium-dose noradrenaline group (risk difference, -6.8%; 95% CI, -9.6% to -4.0%). In the high-dose noradrenaline group, 28-day mortality did not differ significantly between the EEN and LEN groups (absolute risk difference, -1.4%; 95% CI, -7.4%-4.7%).
CONCLUSIONS


Although the size of the subgroup requiring high-dose noradrenaline may have been too small to demonstrate a significant difference, the results suggest that EEN was associated with a reduction in mortality in ventilated adults treated with low- or medium-dose noradrenaline but not in those requiring high-dose noradrenaline.",2020,"The 28-day mortality rate was significantly lower in the EEN than LEN group in the low-dose noradrenaline group (risk difference, -2.9%; 95% confidence interval [CI], -4.5% to -1.3%) and in the medium-dose noradrenaline group (risk difference, -6.8%; 95% CI, -9.6% to -4.0%).","['52,563 eligible patients during the 69-month study period, including 38,488, 11,042, and 3033 patients in the low-, medium-, and high-dose noradrenaline groups, respectively', 'ventilated adults with shock requiring low-, medium-, and high-dose', 'ventilated patients with shock requiring low-, medium-, or high-dose noradrenaline', 'patients with shock requiring vasopressors', 'ventilated patients admitted to intensive care units who had shock requiring catecholamines (noradrenaline or dobutamine) from July 2010 to March 2016']","['LEN', 'early enteral nutrition', 'EEN and late enteral nutrition (LEN', 'noradrenaline']","['mortality', '28-day mortality', '28-day mortality rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1869063', 'cui_str': 'Shock (SMQ)'}, {'cui': 'C0583239', 'cui_str': 'Admission to intensive care unit (procedure)'}, {'cui': 'C0007412', 'cui_str': 'Sympathins'}, {'cui': 'C0012963', 'cui_str': 'Dobutamine'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0086225', 'cui_str': 'Enteral Feeding'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}]",52563.0,0.175953,"The 28-day mortality rate was significantly lower in the EEN than LEN group in the low-dose noradrenaline group (risk difference, -2.9%; 95% confidence interval [CI], -4.5% to -1.3%) and in the medium-dose noradrenaline group (risk difference, -6.8%; 95% CI, -9.6% to -4.0%).","[{'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Ohbe', 'Affiliation': 'Department of Clinical Epidemiology and Health Economics, School of Public Health, The University of Tokyo, Tokyo, Japan. Electronic address: hohbey@gmail.com.'}, {'ForeName': 'Taisuke', 'Initials': 'T', 'LastName': 'Jo', 'Affiliation': 'Department of Health Services Research, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Matsui', 'Affiliation': 'Department of Clinical Epidemiology and Health Economics, School of Public Health, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Kiyohide', 'Initials': 'K', 'LastName': 'Fushimi', 'Affiliation': 'Department of Health Policy and Informatics, Tokyo Medical and Dental University Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hideo', 'Initials': 'H', 'LastName': 'Yasunaga', 'Affiliation': 'Department of Clinical Epidemiology and Health Economics, School of Public Health, The University of Tokyo, Tokyo, Japan.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2019.02.020']
771,31462137,The impact of neutrophil-lymphocyte ratio on risk reclassification of patients with advanced renal cell cancer to guide risk-directed therapy.,"Background:  An elevated neutrophil-lymphocyte ratio (NLR) is associated with poor prognosis in advanced renal cell carcinoma (RCC). We examined whether the addition of NLR improves the risk reclassification of advanced RCC using current prognostic tools from the Memorial Sloan Kettering Cancer Center (MSKCC) and International Metastatic Renal Cell Carcinoma Database Consortium (IMDC). Methods:  Using randomised data from the COMPARZ trial of first-line pazopanib vs. sunitinib in advanced RCC, we constructed multivariable models containing MSKCC and IMDC predictor variables with and without NLR. We evaluated model discrimination using the concordance index (C-index). We computed net reclassification improvement to quantify patient reclassification into low/intermediate/poor risk groups with the addition of NLR. Results:  Of 1102 patients, NLR ≥ 5 (16%) was associated with shorter survival adjusting for MSKCC variables (adjusted HR 1.89,  p  < .001). Adding NLR to MSKCC variables increased the C-index by 0.01. Among patients who died before 24 months ( N  = 415), adding NLR reclassified 8% and 2% to a higher and lower risk category, respectively. Among those alive at 24 months ( N  = 636), adding NLR reclassified 4% and 1% to a higher and lower risk category, respectively. This finding translates to a net benefit of eight additional patients who die within 24 months correctly identified as poor risk per 1000 patients tested. We obtained similar results when evaluating NLR with IMDC variables. Conclusions:  NLR does not substantially improve risk reclassification over pre-existing prognostic tools. MSKCC and IMDC classifications remain the standard for guiding risk-directed therapy and trial stratification of patients with advanced RCC.",2020,An elevated neutrophil-lymphocyte ratio (NLR) is associated with poor prognosis in advanced renal cell carcinoma (RCC).,"['advanced renal cell carcinoma (RCC', 'patients with advanced RCC', 'patients with advanced renal cell cancer to guide risk-directed therapy']","['pazopanib vs. sunitinib', 'NLR', 'neutrophil-lymphocyte ratio']","['elevated neutrophil-lymphocyte ratio (NLR', 'shorter survival adjusting for MSKCC variables', 'C-index']","[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007134', 'cui_str': 'Nephroid Carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1831796', 'cui_str': 'pazopanib'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C4018897', 'cui_str': 'Lymphocyte component of blood'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]","[{'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C4018897', 'cui_str': 'Lymphocyte component of blood'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",1102.0,0.032522,An elevated neutrophil-lymphocyte ratio (NLR) is associated with poor prognosis in advanced renal cell carcinoma (RCC).,"[{'ForeName': 'Angelina', 'Initials': 'A', 'LastName': 'Tjokrowidjaja', 'Affiliation': 'National Health and Medical Research Council Clinical Trials Centre, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Goldstein', 'Affiliation': 'Translational Cancer Research Network, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'H Malcolm', 'Initials': 'HM', 'LastName': 'Hudson', 'Affiliation': 'National Health and Medical Research Council Clinical Trials Centre, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Lord', 'Affiliation': 'National Health and Medical Research Council Clinical Trials Centre, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Val', 'Initials': 'V', 'LastName': 'Gebski', 'Affiliation': 'National Health and Medical Research Council Clinical Trials Centre, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Clarke', 'Affiliation': 'Sydney Medical School, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'de Souza', 'Affiliation': 'Department of Medical Oncology, Liverpool Hospital, Liverpool, Australia.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Motzer', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Chee Khoon', 'Initials': 'CK', 'LastName': 'Lee', 'Affiliation': 'National Health and Medical Research Council Clinical Trials Centre, The University of Sydney, Sydney, Australia.'}]","Acta oncologica (Stockholm, Sweden)",['10.1080/0284186X.2019.1656342']
772,30789807,Association Between Bat Vitamin D Receptor 3' Haplotypes and Vitamin D Levels at Baseline and a Lower Response After Increased Vitamin D Supplementation and Exposure to Sunlight.,"Objective:  The aim of this study was to evaluate the relationship between vitamin D levels at baseline and after 12 weeks of supplementation/exposure to sunlight and VDR genotypes (BsmI, TaqI and ApaI) and haplotypes in a homogeneous population of postmenopausal women.  Methods:  We made a prospective study in which 151 women were randomized to two groups: One with 1000 mg of calcium and 800 IU vitamin D supplementation (102 women) and a placebo group with neither calcium or vitamin D supplementation (49 women). The follow-up was from May to September 2012.Vitamin D was determined by chemiluminescent immunoassay. Genotypes were determined using the Sequenomi Plexplatform and haplotypes using PHASE software.  Results:  Baseline (25 ± 10 ng/ml vs. 23 ± 9 ng/ml, p > 0.05) and 12-week (32 ± 8 ng/ml vs. 29 ± 10 ng/ml, p > 0.05) vitamin D levels were similar between the two groups. The genetic study was made in the total population. There were no differences in baseline and final levels of vitamin D in terms of genotypes and haplotypes, except for the Bat haplotype, whose baseline values were lower (25OHD: 21 ± 10 ng/ml vs.  21 ± 10 ng/ml, p = 0.038). The rate of nonresponders in this group was 15 % (p = 0.001), compared with 9 %, 2 % and 3 % in the other groups.  Conclusions:  The Bat haplotype was associated with lower baseline levels of vitamin D and a worse response to supplementation and, therefore, may be a risk factor for vitamin D deficiency.",2020,"There were no differences in baseline and final levels of vitamin D in terms of genotypes and haplotypes, except for the Bat haplotype, whose baseline values were lower (25OHD: 21 ± 10 ng/ml vs. 21 ± 10 ","['homogeneous population of postmenopausal women', '10', '49 women', '151 women']","['calcium and 800 IU vitamin D supplementation', 'supplementation/exposure to sunlight and VDR genotypes (BsmI, TaqI and ApaI) and haplotypes', 'placebo group with neither calcium or vitamin D supplementation']","['baseline and final levels of vitamin D', 'vitamin D levels', 'Vitamin D Levels', 'rate of nonresponders']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0038817', 'cui_str': 'Sunshine'}, {'cui': 'C1285573', 'cui_str': 'Genotype determination'}, {'cui': 'C0066198', 'cui_str': 'methyl p-azidophenyl acetimidate'}, {'cui': 'C0018591', 'cui_str': 'Haplotypes'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}]",151.0,0.376441,"There were no differences in baseline and final levels of vitamin D in terms of genotypes and haplotypes, except for the Bat haplotype, whose baseline values were lower (25OHD: 21 ± 10 ng/ml vs. 21 ± 10 ","[{'ForeName': 'María', 'Initials': 'M', 'LastName': 'Pérez-Alonso', 'Affiliation': 'Faculty of Medicine, University of Valladolid, Spain.'}, {'ForeName': 'Laisa-Socorro', 'Initials': 'LS', 'LastName': 'Briongos', 'Affiliation': 'Department of Internal Medicine, University Hospital Río Hortega, Valladolid, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Ruiz-Mambrilla', 'Affiliation': 'Faculty of Medicine, University of Valladolid, Spain.'}, {'ForeName': 'Eladio A', 'Initials': 'EA', 'LastName': 'Velasco', 'Affiliation': 'Institute of Molecular and Genetic Biology, University of Valladolid, Spain.'}, {'ForeName': 'José M', 'Initials': 'JM', 'LastName': 'Olmos', 'Affiliation': 'Department of Internal Medicine, University Hospital Marques de Valdecilla, University of Cantabria, Spain.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'de Luis', 'Affiliation': 'Department of Endocrinology, University Hospital Valladolid, University of Valladolid, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Dueñas-Laita', 'Affiliation': 'Department of Clinical Pharmacology, University Hospital Río Hortega, University of Valladolid, Spain.'}, {'ForeName': 'José-Luis', 'Initials': 'JL', 'LastName': 'Pérez-Castrillón', 'Affiliation': 'Department of Internal Medicine, University Hospital Río Hortega, Valladolid, Spain.'}]",International journal for vitamin and nutrition research. Internationale Zeitschrift fur Vitamin- und Ernahrungsforschung. Journal international de vitaminologie et de nutrition,['10.1024/0300-9831/a000534']
773,30789808,No beneficial effects of resveratrol supplementation on atherogenic risk factors in patients with nonalcoholic fatty liver disease.,"Introduction:  Cardiovascular disease (CVD) accounts as a major cause of mortality among patients with nonalcoholic fatty liver disease (NAFLD). Resveratrol, a natural polyphenol compound, is known for its antioxidant and antiatherogenic properties and is purported to be beneficial in decreasing CVD risk factors in NAFLD patients.  Objectives : This study aimed to investigate the effects of resveratrol on atherogenic risk factors in patients with NAFLD.  Methods : This randomized, double-blind, placebo-controlled clinical trial was performed on 50 patients with NAFLD aged 20-60 years. Subjects were randomly assigned to receive a daily dose of 600 mg resveratrol (n = 25) or placebo (n = 25) for 12 wk. Serum liver enzymes, lipid profile and atherogenic indices, blood pressure and anthropometric values were assessed pre and post-treatment.  Results:  Resveratrol supplementation reduced body weight (from 88.75 ± 11.41 to 87.54 ± 11.18 kg, P = 0.005) and BMI (from 31.00 ± 3.16 to 30.60 ± 3.26 kg/m², P = 0.01) significantly compared to the placebo group. A significant reduction in waist circumference was observed within resveratrol group (from 102.70 ± 7.68 to 101.39 ± 7.62 cm, P = 0.02). There were no significant changes in lipid profile (ox-LDL, ApoA1 and ApoB), serum atherogenic indices (LDL-C/HDL-C, ApoB/ApoA1, ox-LDL/ApoB, LDL-C/ox-LDL and AIP), liver enzymes (AST, ALT, ALP and GGT), hip circumference, waist-to-hip ratio and blood pressure in either group (P > 0.05 for all).  Conclusion : These findings indicated that resveratrol supplementation in dose and duration used in this study did not affect most of the CVD risk factors in NAFLD patients. Further studies are warranted to explain more effects of resveratrol on CVD complications of NAFLD.  Registration ID in IRCT:  IRCT201511233664N16.",2020,"There were no significant changes in lipid profile (ox-LDL, ApoA1 and ApoB), serum atherogenic indices (LDL-C/HDL-C, ApoB/ApoA1, ox-LDL/ApoB, LDL-C/ox-LDL and AIP), liver enzymes (AST, ALT, ALP and GGT), hip circumference, waist-to-hip ratio and blood pressure in either group (P > 0.05 for all).
","['patients with NAFLD', 'patients with nonalcoholic fatty liver disease', '50 patients with NAFLD aged 20-60\xa0years', 'patients with nonalcoholic fatty liver disease (NAFLD', 'NAFLD patients']","['placebo', 'resveratrol supplementation']","['waist circumference', 'BMI', 'Serum liver enzymes, lipid profile and atherogenic indices, blood pressure and anthropometric values', 'CVD risk factors', 'lipid profile (ox-LDL, ApoA1 and ApoB), serum atherogenic indices (LDL-C/HDL-C, ApoB/ApoA1, ox-LDL/ApoB, LDL-C/ox-LDL and AIP), liver enzymes (AST, ALT, ALP and GGT), hip circumference, waist-to-hip ratio and blood pressure', 'atherogenic risk factors', 'body weight']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0400966', 'cui_str': 'NAFLD'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2930481', 'cui_str': 'cis-Resveratrol'}]","[{'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme (substance)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0348035', 'cui_str': 'oxidized low density lipoprotein'}, {'cui': 'C0003593', 'cui_str': 'ApoB'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0202035', 'cui_str': 'Gamma glutamyl transferase measurement (procedure)'}, {'cui': 'C0562350', 'cui_str': 'Hip circumference (observable entity)'}, {'cui': 'C0205682', 'cui_str': 'Waist-Hip Ratio'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}]",50.0,0.254393,"There were no significant changes in lipid profile (ox-LDL, ApoA1 and ApoB), serum atherogenic indices (LDL-C/HDL-C, ApoB/ApoA1, ox-LDL/ApoB, LDL-C/ox-LDL and AIP), liver enzymes (AST, ALT, ALP and GGT), hip circumference, waist-to-hip ratio and blood pressure in either group (P > 0.05 for all).
","[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Farzin', 'Affiliation': ""Students' Research Committee, Faculty of Nutrition and Food Science, Tabriz University of Medical Sciences, Tabriz, Iran.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Asghari', 'Affiliation': ""Students' Research Committee, Faculty of Nutrition and Food Science, Tabriz University of Medical Sciences, Tabriz, Iran.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rafraf', 'Affiliation': 'Nutrition Research Center, Department of Community Nutrition, Faculty of Nutrition and Food Science, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Asghari-Jafarabadi', 'Affiliation': 'Road Traffic Injury Research Center, Faculty of Health, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Shirmohammadi', 'Affiliation': 'Liver and Gastrointestinal Diseases Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}]",International journal for vitamin and nutrition research. Internationale Zeitschrift fur Vitamin- und Ernahrungsforschung. Journal international de vitaminologie et de nutrition,['10.1024/0300-9831/a000528']
774,31701378,Real women have (just the right) curves: investigating anti-thin bias in college women.,"BACKGROUND


Weight stigma is associated with negative mental and physical health outcomes across the body mass index (BMI) continuum. However, few studies have examined discrimination experienced by people with low body weights.
OBJECTIVES


This study explored the presence of anti-thin bias, defined as the belief that individuals at lower body weights have undesirable personality characteristics, in young adult women. Additionally, we examined perceived etiology of weight for women with underweight.
METHOD


Participants (N =295 women, age 18.84 ± 2.32) were randomly assigned to read one of the six vignettes about women who differed by race (White and Black) and BMI status (slightly underweight, average weight, and slightly overweight).
RESULTS


Negative personality characteristics were more likely to be ascribed to vignette characters with under- or overweight BMIs, compared to characters with average weight BMIs. Participants were more likely to attribute underweight characters' body weight to an eating disorder (ED) compared with average or overweight characters.
CONCLUSION


Results suggest that women with under- or overweight BMIs experience greater stigmatization for their body weight than women with average BMIs, underscoring the need for research to investigate weight discrimination across the weight spectrum.
LEVEL OF EVIDENCE


Level I, experimental study.",2020,"Participants were more likely to attribute underweight characters' body weight to an eating disorder (ED) compared with average or overweight characters.
","['women with underweight', 'Participants (N\u2009=295\xa0women, age 18.84\xa0± 2.32) were randomly assigned to read one of the six vignettes about women who differed by race (White and Black) and BMI status (slightly underweight, average weight, and slightly overweight', 'college women', 'young adult women']",[],"[""attribute underweight characters' body weight to an eating disorder (ED""]","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0041667', 'cui_str': 'Underweight'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0750482', 'cui_str': 'Slightly (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]",[],"[{'cui': 'C0449234', 'cui_str': 'Attribute (attribute)'}, {'cui': 'C0041667', 'cui_str': 'Underweight'}, {'cui': 'C0007952', 'cui_str': 'Character'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0013473', 'cui_str': 'Eating Disorders'}]",,0.0321017,"Participants were more likely to attribute underweight characters' body weight to an eating disorder (ED) compared with average or overweight characters.
","[{'ForeName': 'Alexandria', 'Initials': 'A', 'LastName': 'Davies', 'Affiliation': 'Department of Psychology, Virginia Commonwealth University, P.O. Box 842018, Richmond, VA, 23284-2018, USA. daviesae@mymail.vcu.edu.'}, {'ForeName': 'C Blair', 'Initials': 'CB', 'LastName': 'Burnette', 'Affiliation': 'Department of Psychology, Virginia Commonwealth University, P.O. Box 842018, Richmond, VA, 23284-2018, USA.'}, {'ForeName': 'Suzanne E', 'Initials': 'SE', 'LastName': 'Mazzeo', 'Affiliation': 'Department of Psychology, Virginia Commonwealth University, P.O. Box 842018, Richmond, VA, 23284-2018, USA.'}]",Eating and weight disorders : EWD,['10.1007/s40519-019-00812-7']
775,15223987,"Indicators of abdominal adiposity in middle-aged participants of the SU.VI.MAX study: relationships with educational level, smoking status and physical inactivity.","OBJECTIVES


Abdominal fat accumulation is a risk factor for type 2 diabetes and cardiovascular disease. Identifying the demographic and lifestyle correlates of abdominal adiposity is an important step to target at-risk populations in prevention programs. There are few data of this kind in France.
METHODS


Anthropometric indicators of overall (body mass index, BMI) and abdominal (waist hip ratio, WHR; waist circumference, WC) adiposity, educational level, smoking status, and physical activity were assessed in 6,705 middle-aged men and women participating in the SU.VI.MAX study.
RESULTS


The likelihood of being obese was increased more than twice in physically inactive subjects of both genders after adjustment for age, smoking status and educational level (OR=2.22, CI95%: 1.74-2.83 in men; OR=2.38, CI95%: 1.84-3.09 in women). Having a high WHR (>=0.95 in men, >=0.80 in women) was more likely in subjects >=50 y, in current smokers, and less likely in men with higher education. The likelihood of having a high WHR was also increased in physically inactive subjects of both genders after adjustment for age, BMI, smoking status and educational level (OR=1.33, CI95%: 1.10-1.60 in men; OR=1.46, CI95%: 1.22-1.74 in women). Having a high WC (>=102 cm in men, >=88 cm in women) was positively associated with age and also with physical inactivity (OR=1.63, CI95%: 1.20-2.22 in women).
CONCLUSIONS


These cross-sectional data suggest significant positive associations of physical inactivity with both the WHR and WC, independently of overall adiposity as assessed by the BMI.",2004,"The likelihood of having a high WHR was also increased in physically inactive subjects of both genders after adjustment for age, BMI, smoking status and educational level","['6,705 middle-aged men and women participating in the SU.VI.MAX study', 'middle-aged participants of the SU.VI.MAX study: relationships with educational level, smoking status and physical inactivity']",[],"['likelihood of being obese', 'BMI, smoking status and educational level', 'physical inactivity', 'likelihood of having a high WHR', 'overall (body mass index, BMI) and abdominal (waist hip ratio, WHR; waist circumference, WC) adiposity, educational level, smoking status, and physical activity', 'abdominal adiposity', 'smoking status and educational level']","[{'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}]",[],"[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0205682', 'cui_str': 'Waist-Hip Ratio'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C1563743', 'cui_str': 'Adiposis'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",6705.0,0.0641574,"The likelihood of having a high WHR was also increased in physically inactive subjects of both genders after adjustment for age, BMI, smoking status and educational level","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Czernichow', 'Affiliation': ""INSERM U557, Institut scientifique et technique de la Nutrition et de l'Alimentation, UMR (INSERM/INRA/CNAM), 5, rue Vertbois, 75003 Paris, France. sebastien.czernichow@cnam.fr""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Bertrais', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Preziosi', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Galan', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Hercberg', 'Affiliation': ''}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Oppert', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes & metabolism,['10.1016/S1262-3636(07)70101-5']
776,31696598,"Liraglutide reduces hyperglycaemia and body weight in overweight, dysregulated insulin-pump-treated patients with type 1 diabetes: The Lira Pump trial-a randomized, double-blinded, placebo-controlled trial.","AIM


To investigate the efficacy of adding the glucagon-like peptide-1 receptor agonist liraglutide to continuous subcutaneous insulin infusion (CSII) in overweight or obese persons with type 1 diabetes and non-optimal glycaemic control.
MATERIALS AND METHODS


A 26-week, randomized, double-blind, placebo-controlled trial including 44 overweight or obese adults with type 1 diabetes randomized 1:1 to liraglutide 1.8 mg once daily (QD) or placebo added to CSII treatment. The primary endpoint was change in haemoglobin A1c (HbA1c). Secondary endpoints included change in insulin dose, CSII settings, glycaemic variability, body weight and patient-reported outcome measures. Finally, adverse effects including hypoglycaemic events were registered.
RESULTS


HbA1c was reduced by 5 mmol/mol (0.5%) from a baseline of 66 mmol/mol (8.2%) in patients treated with liraglutide compared with a non-significant change of +2.3 mmol/mol (0.2%) from a baseline of 66 mmol/mol (8.1%) in patients treated with placebo (between-group difference 7 mmol/mol [0.7%], P < 0.001). Liraglutide reduced total insulin dose by 8 units/day or 16% of total insulin dose (P = 0.008). Mean body weight was reduced by 6.3 kg (P < 0.001) compared with placebo. Concomitantly, time spent in glycaemic target range 4-10 mmol/L (71-180 mg/dL) increased while the risk of hypoglycaemia did not differ between groups at the end of treatment.
CONCLUSION


Liraglutide treatment reduced HbA1c, total daily insulin dose and body weight without increasing the risk of hypoglycaemia in CSII-treated patients with type 1 diabetes and insufficient glycaemic control. Liraglutide may be considered a potential add-on therapy to insulin in this subgroup of patients.",2020,"Liraglutide treatment reduced HbA 1c  , total daily insulin dose and body weight without increasing the risk of hypoglycaemia in CSII-treated patients with type 1 diabetes and insufficient glycaemic control.","['44 overweight or obese adults with type 1 diabetes', 'overweight, dysregulated insulin-pump-treated patients with type 1 diabetes', 'overweight or obese persons with type 1 diabetes and non-optimal glycaemic control']","['glucagon-like peptide-1 receptor agonist liraglutide', 'continuous subcutaneous insulin infusion (CSII', 'liraglutide 1.8 mg once daily (QD) or placebo added to CSII treatment', 'Liraglutide', 'placebo', 'liraglutide']","['HbA 1c  , total daily insulin dose and body weight', 'HbA1c', 'hyperglycaemia and body weight', 'total insulin dose', 'hypoglycaemic events', 'change in insulin dose, CSII settings, glycaemic variability, body weight and patient-reported outcome-measures', 'Mean body weight', 'risk of hypoglycaemia', 'time spent in glycaemic target range', 'change in HbA 1c  ']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1140609', 'cui_str': 'Insulin pump'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0378073', 'cui_str': 'GLP-1 Receptor'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C2959938', 'cui_str': 'Change in insulin dose (procedure)'}, {'cui': 'C4277735', 'cui_str': 'Patient Reported Outcome Measures'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",,0.674401,"Liraglutide treatment reduced HbA 1c  , total daily insulin dose and body weight without increasing the risk of hypoglycaemia in CSII-treated patients with type 1 diabetes and insufficient glycaemic control.","[{'ForeName': 'Thomas F', 'Initials': 'TF', 'LastName': 'Dejgaard', 'Affiliation': 'Steno Diabetes Center Copenhagen, University of Copenhagen, Denmark.'}, {'ForeName': 'Signe', 'Initials': 'S', 'LastName': 'Schmidt', 'Affiliation': 'Steno Diabetes Center Copenhagen, University of Copenhagen, Denmark.'}, {'ForeName': 'Christian S', 'Initials': 'CS', 'LastName': 'Frandsen', 'Affiliation': 'Department of Endocrinology, Copenhagen University Hospital Hvidovre, Hvidovre, Denmark.'}, {'ForeName': 'Dorte', 'Initials': 'D', 'LastName': 'Vistisen', 'Affiliation': 'Steno Diabetes Center Copenhagen, University of Copenhagen, Denmark.'}, {'ForeName': 'Sten', 'Initials': 'S', 'LastName': 'Madsbad', 'Affiliation': 'Department of Endocrinology, Copenhagen University Hospital Hvidovre, Hvidovre, Denmark.'}, {'ForeName': 'Henrik U', 'Initials': 'HU', 'LastName': 'Andersen', 'Affiliation': 'Steno Diabetes Center Copenhagen, University of Copenhagen, Denmark.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Nørgaard', 'Affiliation': 'Steno Diabetes Center Copenhagen, University of Copenhagen, Denmark.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13911']
777,31538396,"MSCopilot, a new multiple sclerosis self-assessment digital solution: results of a comparative study versus standard tests.","BACKGROUND AND PURPOSE


Assessing patients' disability in multiple sclerosis (MS) requires time-consuming batteries of hospital tests. MSCopilot is a software medical device for the self-assessment of patients with MS (PwMS), combining four tests: walking, dexterity, cognition and low contrast vision. The objective was to validate MSCopilot versus the Multiple Sclerosis Functional Composite (MSFC).
METHODS


This multicentre, open-label, randomized, controlled, crossover study enrolled 141 PwMS and 76 healthy controls (HCs). All participants performed MSCopilot and MSFC tests at day 0. To assess reproducibility, 46 PwMS performed the same tests at day 30 ± 3. The primary end-point was the validation of MSCopilot versus MSFC for the identification of PwMS against HCs, quantified using the area under the curve (AUC). The main secondary end-point was the correlation of MSCopilot z-scores with MSFC z-scores.
RESULTS


In all, 116 PwMS and 69 HCs were analysed. The primary end-point was achieved: MSCopilot performance was non-inferior to that of MSFC (AUC 0.92 and 0.89 respectively; P = 0.3). MSCopilot and MSFC discriminated PwMS and HCs with 81% and 76% sensitivity and 82% and 88% specificity respectively. Digital and standard test scores were highly correlated (r = 0.81; P < 0.001). The test-retest study demonstrated the good reproducibility of MSCopilot.
CONCLUSION


This study confirms the reliability of MSCopilot and its usability in clinical practice for the monitoring of MS-related disability.",2020,"The primary endpoint was the validation of MSCopilot versus MSFC for the identification of PwMS against HCs, quantified using area under the curve (AUC).",['enrolled 141 PwMS and 76 healthy controls (HC'],['MSCopilot'],"['MSCopilot performance', 'validation of MSCopilot versus MSFC for the identification of PwMS against HCs, quantified using area under the curve (AUC', 'Digital and standard test scores', 'MSCopilot z-scores with MSFC z-scores']","[{'cui': 'C4517572', 'cui_str': 'One hundred and forty-one'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",[],"[{'cui': 'C0020792', 'cui_str': 'Identification'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}]",141.0,0.023286,"The primary endpoint was the validation of MSCopilot versus MSFC for the identification of PwMS against HCs, quantified using area under the curve (AUC).","[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Maillart', 'Affiliation': 'Department of Neurology, Pitié Salpêtrière Hospital, Paris, France.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Labauge', 'Affiliation': 'Department of Neurology, Montpellier University Hospital, Montpellier, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Cohen', 'Affiliation': 'Department of Neurology, Nice University Hospital, Nice, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Maarouf', 'Affiliation': 'CNRS, CRMBM, APHM, Aix-Marseille University, Marseille, France.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Vukusic', 'Affiliation': 'Department of Neurology, Hospices Civils de Lyon, Bron, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Donzé', 'Affiliation': ""Department of Physical and Rehabilitation Medicine, Groupe Hospitalier de l'Institut Catholique de Lille, Lille, France.""}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Gallien', 'Affiliation': 'Physical Rehabilitation Medicine, Pole Saint Helier, Rennes, France.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'De Sèze', 'Affiliation': 'Department of Neurology, Hôpital Civil, Strasbourg University, Strasbourg, France.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Bourre', 'Affiliation': 'Department of Neurology, Rouen University Hospital, Rouen, France.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Moreau', 'Affiliation': 'Department of Neurology, Dijon University Hospital, Dijon, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Louapre', 'Affiliation': 'Department of Neurology, Pitié Salpêtrière Hospital, Paris, France.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Mayran', 'Affiliation': 'PM Santé, Garches, France.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Bieuvelet', 'Affiliation': 'Ad Scientiam, Brain and Spine Institute (ICM), Pitié Salpêtrière Hospital, Paris, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Vallée', 'Affiliation': 'Ad Scientiam, Brain and Spine Institute (ICM), Pitié Salpêtrière Hospital, Paris, France.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Bertillot', 'Affiliation': 'Ad Scientiam, Brain and Spine Institute (ICM), Pitié Salpêtrière Hospital, Paris, France.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Klaeylé', 'Affiliation': 'Ad Scientiam, Brain and Spine Institute (ICM), Pitié Salpêtrière Hospital, Paris, France.'}, {'ForeName': 'A-L', 'Initials': 'AL', 'LastName': 'Argoud', 'Affiliation': 'Ad Scientiam, Brain and Spine Institute (ICM), Pitié Salpêtrière Hospital, Paris, France.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Zinaï', 'Affiliation': 'Ad Scientiam, Brain and Spine Institute (ICM), Pitié Salpêtrière Hospital, Paris, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Tourbah', 'Affiliation': 'Department of Neurology, Reims University Hospital, URCA, Reims, France.'}]",European journal of neurology,['10.1111/ene.14091']
778,31520611,Electroencephalography correlates of transcranial direct-current stimulation enhanced surgical skill learning: A replication and extension study.,"Transcranial direct-current stimulation (tDCS), an increasingly applied form of non-invasive brain stimulation, can augment the acquisition of motor skills. Motor learning investigations of tDCS are limited to simple skills, where mechanisms are increasingly understood. Investigations of meaningful, complex motor skills possessed by humans, such as surgical skills, are limited. This replication and extension of our previous findings used electroencephalography (EEG) to determine how tDCS and complex surgical training alters electrical activity in the sensorimotor network to enhance complex surgical skill acquisition. In twenty-two participants, EEG was recorded during baseline performance of simulation-based laparoscopic surgical skills. Participants were randomized to receive 20 min of primary motor cortex targeting anodal tDCS or sham concurrent to 1 h of surgical skill training. EEG was reassessed following training, during a post-training repetition of the surgical tasks. Our results replicated our previous study suggesting that compared to sham, anodal tDCS enhanced the acquisition of unimanual surgical skill. Surgical training modulated delta frequency band activity in sensorimotor regions. Next, the performance of unimanual and bimanual skills evoked unique EEG profiles, primarily within the beta frequency-band in parietal regions. Finally, tDCS-paired surgical training independently modulated delta and alpha frequency-bands in sensorimotor regions. Application of tDCS during surgical skill training is feasible, safe and tolerable. In conclusion, we are the first to explore electrical brain activity during performance of surgical skills, how electrical activity may change during surgical training and how tDCS alters the brain to enhance skill acquisition. The results provide preliminary evidence of neural markers that can be targeted by neuromodulation to optimize complex surgical training.",2019,"Next, the performance of unimanual and bimanual skills evoked unique EEG profiles, primarily within the beta frequency-band in parietal regions.",[],"['Transcranial direct-current stimulation (tDCS', 'tDCS', 'electroencephalography (EEG', 'anodal tDCS', '20\u202fmin of primary motor cortex targeting anodal tDCS or sham concurrent to 1\u202fh of surgical skill training', 'transcranial direct-current stimulation enhanced surgical skill learning']",['acquisition of unimanual surgical skill'],[],"[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0013819', 'cui_str': 'EEG'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C3495441', 'cui_str': 'Precentral Motor Cortex'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0700308', 'cui_str': 'Protium (substance)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0559197', 'cui_str': 'Skills training (procedure)'}]","[{'cui': 'C0543467', 'cui_str': 'Operative Procedures'}]",22.0,0.0285115,"Next, the performance of unimanual and bimanual skills evoked unique EEG profiles, primarily within the beta frequency-band in parietal regions.","[{'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Ciechanski', 'Affiliation': 'Faculty of Medicine and Dentistry, University of Alberta, 1-002 Katz Group Centre for Pharmacy and Health Research, Edmonton, Alberta T6G 2E1, Canada. Electronic address: ciechans@ualberta.ca.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Kirton', 'Affiliation': 'Departments of Clinical Neurosciences, Pediatrics and Radiology, University of Calgary, 2500 University Drive NW, Calgary, Alberta T2N 1N4, Canada. Electronic address: Adam.Kirton@ahs.ca.'}, {'ForeName': 'Bethan', 'Initials': 'B', 'LastName': 'Wilson', 'Affiliation': 'Department of Health Sciences, Carleton University, 2305 Health Sciences Building, 1125 Colonel By Drive, Ottawa, Ontario K1S 5B6, Canada. Electronic address: BethanWilson@cmail.carleton.ca.'}, {'ForeName': 'Chad C', 'Initials': 'CC', 'LastName': 'Williams', 'Affiliation': 'Centre for Biomedical Research, University of Victoria, PO Box 1700 STN CSC, Victoria, BC V8W 2Y2, Canada. Electronic address: ccwillia@uvic.ca.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Anderson', 'Affiliation': 'Veterinary Clinical and Diagnostic Sciences, University of Calgary, 2500 University Drive NW, Calgary, Alberta T2N 1N4, Canada. Electronic address: anderssj@ucalgary.ca.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Cheng', 'Affiliation': 'Department of Pediatrics and Emergency Medicine, University of Calgary, 2500 University Drive NW, Calgary, Alberta T2N 1N4, Canada. Electronic address: chenger@me.com.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Lopushinsky', 'Affiliation': 'Department of Surgery, University of Calgary, 2500 University Drive NW, Calgary, Alberta T2N 1N4, Canada. Electronic address: Steven.Lopushinsky@ahs.ca.'}, {'ForeName': 'Kent G', 'Initials': 'KG', 'LastName': 'Hecker', 'Affiliation': 'Departments of Community Health Sciences and Veterinary Clinical and Diagnostic Sciences, University of Calgary, 2500 University Drive NW, Calgary, Alberta T2N 1N4, Canada. Electronic address: kghecker@ucalgary.ca.'}]",Brain research,['10.1016/j.brainres.2019.146445']
779,30720503,"Proving the Effectiveness of the Fundamentals of Robotic Surgery (FRS) Skills Curriculum: A Single-blinded, Multispecialty, Multi-institutional Randomized Control Trial.","MINI: Question: Is the Fundamentals of Robotic Surgery (FRS) proficiency-based progression curriculum effective for teaching basic robotic surgery skills?
FINDINGS


In an international multi-institutional, multispecialty, blinded, randomized control trial, implementation of the FRS skills curriculum using various simulation platforms led to improved performance of surgical trainees on a transfer test compared with controls.Meaning: The FRS is an effective simulation-based course for training to proficiency on basic robotic surgery skills before surgeons apply those skills clinically.
OBJECTIVE


To demonstrate the noninferiority of the fundamentals of robotic surgery (FRS) skills curriculum over current training paradigms and identify an ideal training platform.
SUMMARY BACKGROUND DATA


There is currently no validated, uniformly accepted curriculum for training in robotic surgery skills.
METHODS


Single-blinded parallel-group randomized trial at 12 international American College of Surgeons (ACS) Accredited Education Institutes (AEI). Thirty-three robotic surgery experts and 123 inexperienced surgical trainees were enrolled between April 2015 and November 2016. Benchmarks (proficiency levels) on the 7 FRS Dome tasks were established based on expert performance. Participants were then randomly assigned to 4 training groups: Dome (n = 29), dV-Trainer (n = 30), and DVSS (n = 32) that trained to benchmarks and control (n = 32) that trained using locally available robotic skills curricula. The primary outcome was participant performance after training based on task errors and duration on 5 basic robotic tasks (knot tying, continuous suturing, cutting, dissection, and vessel coagulation) using an avian tissue model (transfer-test). Secondary outcomes included cognitive test scores, GEARS ratings, and robot familiarity checklist scores.
RESULTS


All groups demonstrated significant performance improvement after skills training (P < 0.01). Participating residents and fellows performed tasks faster (DOME and DVSS groups) and with fewer errors than controls (DOME group; P < 0.01). Inter-rater reliability was high for the checklist scores (0.82-0.97) but moderate for GEARS ratings (0.40-0.67).
CONCLUSIONS


We provide evidence of effectiveness for the FRS curriculum by demonstrating better performance of those trained following FRS compared with controls on a transfer test. We therefore argue for its implementation across training programs before surgeons apply these skills clinically.",2019,We provide evidence of effectiveness for the FRS curriculum by demonstrating better performance of those trained following FRS compared with controls on a transfer test.,"['FRS) Skills Curriculum', 'Thirty-three robotic surgery experts and 123 inexperienced surgical trainees were enrolled between April 2015 and November 2016', '12 international American College of Surgeons (ACS']","['MINI', 'Robotic Surgery', 'robotic surgery (FRS) skills curriculum', 'DVSS (n = 32) that trained to benchmarks and control (n = 32) that trained using locally available robotic skills curricula', 'FRS', 'dV-Trainer']","['GEARS ratings', 'cognitive test scores, GEARS ratings, and robot familiarity checklist scores', 'participant performance after training based on task errors and duration on 5 basic robotic tasks (knot tying, continuous suturing, cutting, dissection, and vessel coagulation) using an avian tissue model (transfer-test']","[{'cui': 'C0220815', 'cui_str': 'curriculum'}, {'cui': 'C0450358', 'cui_str': '33 (qualifier value)'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}]","[{'cui': 'C0445542', 'cui_str': 'Mini (qualifier value)'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0220815', 'cui_str': 'curriculum'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0525063', 'cui_str': 'Best Practice Analysis'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0010478', 'cui_str': 'Curriculum'}, {'cui': 'C0453962', 'cui_str': 'Trainers (physical object)'}]","[{'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0336537', 'cui_str': 'Robot, device (physical object)'}, {'cui': 'C0600269', 'cui_str': 'Familiarity'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0560032', 'cui_str': 'knot (qualifier value)'}, {'cui': 'C0453920', 'cui_str': 'Tie (physical object)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0012737', 'cui_str': 'Dissection'}, {'cui': 'C0148346', 'cui_str': 'Vessel'}, {'cui': 'C0441509', 'cui_str': 'Coagulation - action (qualifier value)'}, {'cui': 'C0005595', 'cui_str': 'Aves'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}]",,0.168174,We provide evidence of effectiveness for the FRS curriculum by demonstrating better performance of those trained following FRS compared with controls on a transfer test.,"[{'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Satava', 'Affiliation': 'Department of Surgery, University of Washington Medical Center, Seattle, WA.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Stefanidis', 'Affiliation': 'Department of Surgery, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Levy', 'Affiliation': 'Department of Ob/Gyn, Drexel University College of Medicine, Institute of Surgical Excellence, Philadelphia, PA.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Smith', 'Affiliation': 'Florida Hospital Nicholson Center, University of Central Florida College of Medicine, Celebration, FL.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Martin', 'Affiliation': 'Department of Surgery, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Monfared', 'Affiliation': 'Department of Surgery, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Lava R', 'Initials': 'LR', 'LastName': 'Timsina', 'Affiliation': 'Department of Surgery, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Ara Wardkes', 'Initials': 'AW', 'LastName': 'Darzi', 'Affiliation': ""Department of Surgery, St. Mary's Hospital, Imperial College, London, UK.""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Moglia', 'Affiliation': 'EndoCAS Simulation Center, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Timothy C', 'Initials': 'TC', 'LastName': 'Brand', 'Affiliation': 'Andersen Simulation Center, Madigan Army Medical Center, Tacoma, WA.'}, {'ForeName': 'Ryan P', 'Initials': 'RP', 'LastName': 'Dorin', 'Affiliation': 'Center for Education, Simulation and Innovation, Hartford Hospital, Hartford, CT.'}, {'ForeName': 'Kristoffel R', 'Initials': 'KR', 'LastName': 'Dumon', 'Affiliation': 'Penn Medicine Clinical Simulation Center, Philadelphia, PA.'}, {'ForeName': 'Todd D', 'Initials': 'TD', 'LastName': 'Francone', 'Affiliation': 'Department of Colon and Rectal Surgery, Lahey Health and Medical Center, Burlington, MA.'}, {'ForeName': 'Evangelos', 'Initials': 'E', 'LastName': 'Georgiou', 'Affiliation': 'National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Alvin C', 'Initials': 'AC', 'LastName': 'Goh', 'Affiliation': 'Houston Methodist Hospital, Methodist Institute for Technology, Innovation, and Education, Houston, TX.'}, {'ForeName': 'Jorge E', 'Initials': 'JE', 'LastName': 'Marcet', 'Affiliation': 'USF Health Center for Advanced Medical Learning and Simulation, Tampa, FL.'}, {'ForeName': 'Martin A', 'Initials': 'MA', 'LastName': 'Martino', 'Affiliation': 'Lehigh Valley Health Network, Allentown, PA.'}, {'ForeName': 'Ranjan', 'Initials': 'R', 'LastName': 'Sudan', 'Affiliation': 'Department of Surgery, Surgical Education and Activities Lab, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Vale', 'Affiliation': 'EndoCAS Simulation Center, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Anthony G', 'Initials': 'AG', 'LastName': 'Gallagher', 'Affiliation': 'Technology Enhanced Learning, ASSERT Centre, College of Medicine and Health, Brookfield Health Sciences Complex, University College Cork, Cork, Ireland.'}]",Annals of surgery,['10.1097/SLA.0000000000003220']
780,31399906,A randomized phase 2 trial of apatinib vs observation as maintenance treatment following first-line induction chemotherapy in extensive- stage small cell lung cancer.,"Background The 5-year survival rate for extensive-disease small-cell lung carcinoma (ED-SCLC) is only 1%. Recently, apatinib exerted promising effects on cancer patients after failure of first-line chemotherapy. Methods This study enrolled 24 ED-SCLC patients to study the efficacy and toxicity of apatinib in combination with chemotherapy and maintenance therapy. The primary endpoints were overall survival (OS) and progression-free survival (PFS). The secondary endpoints included toxicity and safety. Apatinib was given 250 mg/day during the chemotherapy interval, and as maintenance therapy after 4-6 cycles until the patient progressed, died, or was intolerant to drug toxicity. The study further evaluated the cytotoxicity, cell-cycle arrest and apoptotic induction of apatinib in A549 and H446 cells. Results There was no difference in short-term efficacy between combined and chemotherapy groups. Long-term efficacy showed that the median PFS was 7.8 months and 4.9 months in combination and chemotherapy groups, respectively [p = 0.002, HR(95%CI): 0.18(0.06-0.60)]. The median OS was 12.1 months and 8.2 months in combination and chemotherapy groups, respectively [p = 0.023, HR(95%CI): 0.38 (0.16-0.90)]. Multivariate Cox regression analysis showed that apatinib combined with chemotherapy was an independent prognostic factor for OS and PFS. The ECOG score was an independent prognostic factor affecting OS. In vitro analysis showed that apatinib inhibited cell proliferation and caused cell-cycle arrest and apoptosis. Conclusion Apatinib combination/maintenance therapy showed promising efficacy and safety to extend OS/PFS in ED-SCLC and will be a potent therapeutic option in future practice. Although the scale of this study is small, further research on large sample sizes is needed.",2020,There was no difference in short-term efficacy between combined and chemotherapy groups.,"['enrolled 24 ED-SCLC patients', 'extensive- stage small cell lung cancer', 'cancer patients after failure of first-line chemotherapy']","['chemotherapy and maintenance therapy', 'line induction chemotherapy', 'apatinib vs observation']","['cytotoxicity, cell-cycle arrest and apoptotic induction of apatinib in A549 and H446 cells', 'median PFS', 'toxicity and safety', '5-year survival rate', 'efficacy and toxicity', 'cell proliferation and caused cell-cycle arrest and apoptosis', 'median OS', 'efficacy and safety', 'short-term efficacy', 'overall survival (OS) and progression-free survival (PFS', 'ECOG score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205231', 'cui_str': 'Extensive (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0149925', 'cui_str': 'Oat Cell Lung Cancer'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C3179010', 'cui_str': 'Induction Chemotherapy'}, {'cui': 'C2346836', 'cui_str': '3-Pyridinecarboxamide, N-(4-(1-cyanocyclopentyl)phenyl)-2-((4-methyl-3-pyridinyl)amino)-'}, {'cui': 'C0302523', 'cui_str': 'Observation'}]","[{'cui': 'C1155873', 'cui_str': 'Cell Cycle Arrest'}, {'cui': 'C2346836', 'cui_str': '3-Pyridinecarboxamide, N-(4-(1-cyanocyclopentyl)phenyl)-2-((4-methyl-3-pyridinyl)amino)-'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0596290', 'cui_str': 'Cell Proliferation'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0162638', 'cui_str': 'Programmed Cell Death, Type I'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0430797', 'cui_str': 'Intracranial EEG'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",24.0,0.0780775,There was no difference in short-term efficacy between combined and chemotherapy groups.,"[{'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Luo', 'Affiliation': 'Cancer Center, Daping Hospital & Army Medical Center of PLA, Army Medical University, Chongqing, 400042, China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Cancer Center, Daping Hospital & Army Medical Center of PLA, Army Medical University, Chongqing, 400042, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Yang', 'Affiliation': 'Cancer Center, Daping Hospital & Army Medical Center of PLA, Army Medical University, Chongqing, 400042, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Feng', 'Affiliation': 'Cancer Center, Daping Hospital & Army Medical Center of PLA, Army Medical University, Chongqing, 400042, China.'}, {'ForeName': 'Yanli', 'Initials': 'Y', 'LastName': 'Xiong', 'Affiliation': 'Cancer Center, Daping Hospital & Army Medical Center of PLA, Army Medical University, Chongqing, 400042, China.'}, {'ForeName': 'Shiheng', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Cancer Center, Daping Hospital & Army Medical Center of PLA, Army Medical University, Chongqing, 400042, China.'}, {'ForeName': 'Xuemei', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Cancer Center, Daping Hospital & Army Medical Center of PLA, Army Medical University, Chongqing, 400042, China.'}, {'ForeName': 'Chengyuan', 'Initials': 'C', 'LastName': 'Qian', 'Affiliation': 'Cancer Center, Daping Hospital & Army Medical Center of PLA, Army Medical University, Chongqing, 400042, China.'}, {'ForeName': 'Wang', 'Initials': 'W', 'LastName': 'Dong', 'Affiliation': 'Cancer Center, Daping Hospital & Army Medical Center of PLA, Army Medical University, Chongqing, 400042, China.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Dai', 'Affiliation': 'Cancer Center, Daping Hospital & Army Medical Center of PLA, Army Medical University, Chongqing, 400042, China. dn400042@hotmail.com.'}]",Investigational new drugs,['10.1007/s10637-019-00828-x']
781,31687738,Hookah is the enemy of health campaign: a campaign for prevention of hookah smoking among youth.,"Hookah smoking is now a serious health threat especially for adolescents. Implementation of planned interventions can help reduce hookah smoking. This study was conducted to investigate the effect of a campaign Hookah is the Enemy of Health Campaign (HEHC) based on the protection motivation theory to prevent hookah smoking among the youth in Sirjan city, in 2018. This was a pre- and post-intervention study. Participants were 280 male and female youth who were selected randomly through the health centers of Sirjan. The educational campaign was conducted during 3 months and participants were trained through interpersonal, group, organizational and community channels and mass media. Data were collected by filling out a questionnaire (containing 64 questions) by the participant before the intervention and 3 months after. Data were analyzed by descriptive statistics (frequency and percentage), chi-square and Wilcoxon signed-rank test by SPSS20 software. The prevalence of hookah smoking was 44.3% in the target group. There was a significant change in the mean scores of knowledge and perceived susceptibility, perceived severity, response efficiency, self-efficacy, rewards, fear and protection motivation after the HEHC (p < 0.05), but there was no significant difference in the structure of perceived cost (p > 0.05). Also, the prevalence of hookah smoking among the target group for those who had ever consumed decreased from 8.9 to 4% and for those who used it occasionally decreased from 35 to 19.4%. The HEHC was effective in reducing hookah smoking, raising knowledge and improving the constructs of the protection motivation theory among the youth of Sirjan.",2020,"The HEHC was effective in reducing hookah smoking, raising knowledge and improving the constructs of the protection motivation theory among the youth of Sirjan.","['hookah smoking among the youth in Sirjan city, in 2018', 'Participants were 280 male and female youth who were selected randomly through the health centers of Sirjan']","['campaign Hookah', 'HEHC']","['hookah smoking', 'structure of perceived cost', 'prevalence of hookah smoking', 'mean scores of knowledge and perceived susceptibility, perceived severity, response efficiency, self-efficacy, rewards, fear and protection motivation after the HEHC']","[{'cui': 'C4046008', 'cui_str': 'Hookah Smoking'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0475309', 'cui_str': 'Health center (environment)'}]","[{'cui': 'C4302493', 'cui_str': 'Smoking Water Pipes'}]","[{'cui': 'C4046008', 'cui_str': 'Hookah Smoking'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1264642', 'cui_str': 'Susceptibility (property) (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}]",280.0,0.0207426,"The HEHC was effective in reducing hookah smoking, raising knowledge and improving the constructs of the protection motivation theory among the youth of Sirjan.","[{'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Sadeghi', 'Affiliation': 'Department of Health Education & Promotion, Social Determinants of Health Research Center, School of Public Health, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Seyed Saeed', 'Initials': 'SS', 'LastName': 'Mazloomy Mahmoodabad', 'Affiliation': 'Department of Health Education & Promotion, Social Determinants of Health Research Center, School of Public Health, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Fallahzadeh', 'Affiliation': 'Departments of Biostatistics and Epidemiology, Research Center of Prevention and Epidemiology of Non-Communicable Disease, School of Public Health, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Rezaeian', 'Affiliation': 'Epidemiology and Biostatistics Department, Occupational Environmental Research Center, Rafsanjan Medical School, Rafsanjan University of Medical Sciences, Rafsanjan, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Bidaki', 'Affiliation': 'Research Center of Addiction and Behavioral Sciences, Diabetes Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Narges', 'Initials': 'N', 'LastName': 'Khanjani', 'Affiliation': 'Neurology Research Center, Kerman University of Medical Sciences, Kerman, Iran.'}]",Health promotion international,['10.1093/heapro/daz109']
782,31688064,"Efficacy and Safety of Vonoprazan in Patients With Nonerosive Gastroesophageal Reflux Disease: A Randomized, Placebo-Controlled, Phase 3 Study.","OBJECTIVES


To assess the efficacy and safety of vonoprazan on heartburn symptoms in patients with nonerosive reflux disease (NERD) (ClinicalTrials.gov: NCT02954848).
METHODS


This phase 3, double-blind, placebo-controlled study included Japanese patients aged 20 years and older with grade N/M NERD and recurrent heartburn. Patients received placebo (n = 245) or vonoprazan 10 mg (n = 238) for 4 weeks. The primary efficacy outcome was frequency of heartburn experienced by patients during the treatment period (proportion of days without heartburn). Other outcomes included cumulative improvement rates of heartburn, proportion of patients with complete heartburn resolution in the fourth week of treatment, and safety.
RESULTS


Compared with placebo, the proportion of days without heartburn was not significantly higher in the vonoprazan group in the full analysis (primary end point, 72.55% vs 61.50%, vonoprazan vs placebo, P = 0.0643) but was significantly higher in the per-protocol-set sensitivity analysis (P = 0.0341). Early onset of response and significantly greater cumulative improvement rates of heartburn were observed in the vonoprazan group (P = 0.0003). In a post hoc analysis, a greater proportion of patients with complete heartburn resolution in the fourth week of treatment were reported in the vonoprazan group (P = 0.0023). Incidence of treatment-emergent adverse events was similar between treatment groups (23.5% vs 23.3%); most treatment-emergent adverse events were mild in severity.
DISCUSSION


Although vonoprazan 10 mg was not superior to placebo with respect to proportion of days without heartburn in Japanese patients with NERD, vonoprazan had a significantly higher cumulative rate of heartburn resolution and was well tolerated.",2019,"Incidence of treatment-emergent adverse events was similar between treatment groups (23.5% vs 23.3%); most treatment-emergent adverse events were mild in severity.
","['Patients With Nonerosive Gastroesophageal Reflux Disease', 'Japanese patients with NERD', 'patients with nonerosive reflux disease (NERD', 'Japanese patients aged 20 years and older with grade N/M NERD and recurrent heartburn']","['placebo', 'Placebo', 'Vonoprazan', 'vonoprazan']","['cumulative improvement rates of heartburn, proportion of patients with complete heartburn resolution', 'safety', 'tolerated', 'cumulative rate of heartburn resolution', 'Incidence of treatment-emergent adverse events', 'efficacy and safety', 'complete heartburn resolution', 'heartburn symptoms', 'cumulative improvement rates of heartburn', 'proportion of days without heartburn', 'Efficacy and Safety', 'frequency of heartburn experienced by patients during the treatment period (proportion of days without heartburn']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0017168', 'cui_str': 'Gastric Acid Reflux Disease'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0018834', 'cui_str': 'Pyrosis'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4080009', 'cui_str': 'Vonoprazan'}]","[{'cui': 'C0018834', 'cui_str': 'Pyrosis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}]",,0.488409,"Incidence of treatment-emergent adverse events was similar between treatment groups (23.5% vs 23.3%); most treatment-emergent adverse events were mild in severity.
","[{'ForeName': 'Yoshikazu', 'Initials': 'Y', 'LastName': 'Kinoshita', 'Affiliation': 'Department of Gastroenterology and Hepatology, Shimane University School of Medicine, Izumo, Japan.'}, {'ForeName': 'Yuuichi', 'Initials': 'Y', 'LastName': 'Sakurai', 'Affiliation': 'Takeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, Japan.'}, {'ForeName': 'Nobuyoshi', 'Initials': 'N', 'LastName': 'Takabayashi', 'Affiliation': 'Takeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, Japan.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Kudou', 'Affiliation': 'Takeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Araki', 'Affiliation': 'Takeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, Japan.'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Miyagi', 'Affiliation': 'Department of Internal Medicine, Fukuyama Daiichi Hospital, Hiroshima, Japan.'}, {'ForeName': 'Katsuhiko', 'Initials': 'K', 'LastName': 'Iwakiri', 'Affiliation': 'Department of Gastroenterology, Nippon Medical School Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Kiyoshi', 'Initials': 'K', 'LastName': 'Ashida', 'Affiliation': 'Department of Gastroenterology, Rakuwakai Otowa Hospital, Kyoto, Japan.'}]",Clinical and translational gastroenterology,['10.14309/ctg.0000000000000101']
783,31664940,Association of platelet function with depression and its treatment with sertraline in patients with chronic kidney disease: analysis of a randomized trial.,"BACKGROUND


Major Depressive Disorder (MDD) can lead to adverse cardiovascular outcomes in patients with chronic kidney disease (CKD). Although one of the proposed mechanisms is heightened platelet activation, effects of MDD and its treatment with a selective serotonin reuptake inhibitor (SSRI) on platelet function in patients with CKD remain unclear.
METHODS


In a pre-specified analysis, changes from baseline to 12 weeks in whole blood platelet aggregation (WBPA) and plasma levels of E-selectin and P-selectin on treatment with sertraline vs. placebo were investigated in 175 patients with CKD (estimated glomerular filtration rate [eGFR] < 60 ml/min/1.73m 2 ) and MDD (MDD+/CKD+) in a randomized, double-blind trial. Correlations between severity of depressive symptoms and platelet function were also analyzed. In order to investigate whether differences in platelet function were due to presence of CKD or MDD, we compared a subgroup of 49 MDD+/CKD+ patients with eGFR < 30 ml/min/1.73m 2  to 43 non-depressed CKD controls (28 CKD with eGFR < 30 ml/min/1.73m 2  [MDD-/CKD+] and 15 individuals with eGFR ≥90 ml/min/1.73m 2  [MDD-/CKD-].
RESULTS


In MDD+/CKD+ individuals, there were no significant correlations between severity of depressive symptoms and platelet function, and no significant changes in platelet function after 12 weeks of treatment with sertraline vs. placebo. There were no significant differences in platelet function among MDD+/CKD+ patients and controls without MDD except in WBPA to 10 μM ADP (P = 0.03). WBPA to ADP was lower in the MDD-/CKD- group (8.0 Ω [5.0 Ω, 11.0 Ω]) as compared to the MDD-/CKD+ group (12.5 Ω [8.0 Ω, 14.5 Ω]), P = 0.01, and the MDD+/CKD+ group (11.0 Ω [8.0 Ω, 15.0 Ω]), P < 0.01.
CONCLUSIONS


Heightened ADP-induced platelet aggregability was observed in CKD patients compared to controls with normal kidney function, regardless of presence of comorbid MDD, and treatment with sertraline did not affect platelet function. These findings suggest that increased platelet activation may not be a major contributory underlying mechanism by which depression may lead to worse cardiovascular outcomes in patients with CKD. Future studies should include positive MDD controls without CKD to confirm our findings.
TRIAL REGISTRATION


ClinicalTrials.gov identifier numbers: CAST Study: NCT00946998 (Recruitment Status: Completed. First Posted: July 27, 2009. Results First Posted: January 30, 2018). WiCKDonASA Study: NCT01768637 (Recruitment Status: Completed. First Posted: January 15, 2013. Results First Posted: April 19, 2019).",2019,There were no significant differences in platelet function among MDD+/CKD+ patients and controls without MDD except in WBPA to 10 μM ADP (P = 0.03).,"['patients with chronic kidney disease (CKD', '15 individuals with eGFR ≥90', 'patients with chronic kidney disease', '175 patients with CKD', 'patients with CKD remain unclear', 'patients with CKD']","['WiCKDonASA', 'MDD-/CKD', 'serotonin reuptake inhibitor (SSRI', 'MDD+/CKD', 'sertraline', 'sertraline vs. placebo', 'MDD (MDD+/CKD']","['blood platelet aggregation (WBPA) and plasma levels of E-selectin', 'severity of depressive symptoms and platelet function', 'platelet aggregability', 'depressive symptoms and platelet function', 'WBPA to ADP', 'platelet function']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C4517605', 'cui_str': '175'}]","[{'cui': 'C0162758', 'cui_str': '5-HT Uptake Inhibitors'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0332621', 'cui_str': 'Aggregation (finding)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0115305', 'cui_str': 'LECAM-2'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C1254881', 'cui_str': 'Platelet function'}, {'cui': 'C0001459', 'cui_str': ""Adenosine 5'-Pyrophosphate""}]",175.0,0.0493685,There were no significant differences in platelet function among MDD+/CKD+ patients and controls without MDD except in WBPA to 10 μM ADP (P = 0.03).,"[{'ForeName': 'Nishank', 'Initials': 'N', 'LastName': 'Jain', 'Affiliation': 'Department of Internal Medicine, University of Arkansas for Medical Sciences, 5323 Harry Hines Blvd, MC 8516, Dallas, TX, 75390, USA.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Wan', 'Affiliation': 'Department of Biostatistics, University of Arkansas for Medical Sciences, Little Rock, USA.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Kothari', 'Affiliation': 'Department of Internal Medicine, University of Arkansas for Medical Sciences, 5323 Harry Hines Blvd, MC 8516, Dallas, TX, 75390, USA.'}, {'ForeName': 'Anuoluwapo', 'Initials': 'A', 'LastName': 'Adelodun', 'Affiliation': 'Department of Internal Medicine, University of Texas Southwestern Medical Center, 5959 Harry Hines Blvd, MC 8516, Dallas, TX, 75390, USA.'}, {'ForeName': 'Jerry', 'Initials': 'J', 'LastName': 'Ware', 'Affiliation': 'Department of Physiology and Biophysics, University of Arkansas for Medical Sciences, Little Rock, USA.'}, {'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Sarode', 'Affiliation': 'Department of Internal Medicine, University of Texas Southwestern Medical Center, 5959 Harry Hines Blvd, MC 8516, Dallas, TX, 75390, USA.'}, {'ForeName': 'S Susan', 'Initials': 'SS', 'LastName': 'Hedayati', 'Affiliation': 'Department of Internal Medicine, University of Texas Southwestern Medical Center, 5959 Harry Hines Blvd, MC 8516, Dallas, TX, 75390, USA. susan.hedayati@utsouthwestern.edu.'}]",BMC nephrology,['10.1186/s12882-019-1576-7']
784,31667987,Lung ultrasound-guided treatment in ambulatory patients with heart failure: a randomized controlled clinical trial (LUS-HF study).,"AIMS


Lung ultrasound (LUS) is a useful tool with which to assess subclinical pulmonary congestion and to stratify the prognosis of patients with heart failure (HF). The aim of this study was to evaluate whether an LUS-guided follow-up protocol improves the outcomes of patients with HF.
METHODS AND RESULTS


In this single-blind clinical trial, 123 patients admitted for HF were randomized to either a standard follow-up (n = 62, control group) or a LUS-guided follow-up (n = 61, LUS group). The primary endpoint was a composite of urgent visit, hospitalization for worsening HF and death during follow-up. Visits were scheduled at 14, 30, 90 and 180 days after discharge. Treating physicians were encouraged to modify diuretic therapy in accordance with the number of B-lines recorded by LUS. The mean ± standard deviation (SD) age of the patients was 69 ± 12 years and 72% were male. The mean ± SD left ventricular ejection fraction was 39 ± 14%. The hazard ratio for the primary outcome in the LUS group was 0.518 [95% confidence interval (CI) 0.268-0.998; P = 0.049], mainly resulting from a decrease in the number of urgent visits for worsening HF. The number of patients needed to treat to avoid an event was 5 (95% CI 3-62). Other secondary endpoints such as N-terminal pro-B-type natriuretic peptide reduction were not achieved. The safety parameters were similar in the two groups. Patients in the LUS group received more loop diuretics [51 (91%) vs. 42 (75%); P = 0.02] and showed an improvement in the distance achieved in the 6-min walking test [60 m (interquartile range: 29-125 m) vs. 37 m (interquartile range: 5-70 m); P = 0.023].
CONCLUSIONS


Tailored LUS-guided diuretic treatment of pulmonary congestion in this proof-of-concept study reduced the number of decompensations and improved walking capacity in patients with HF. LUS is a non-invasive, safe and easy-to-use technique with potential clinical applicability to guide pulmonary congestion treatment in patients with HF.",2019,"LUS is a non-invasive, safe and easy-to-use technique with potential clinical applicability to guide pulmonary congestion treatment in patients with HF.","['123 patients admitted for HF', 'patients with HF', 'patients with heart failure (HF', 'ambulatory patients with heart failure', 'age of the patients was 69\u2009±\u200912\u2009years and 72% were male']","['Lung ultrasound-guided treatment', 'LUS-guided follow-up protocol', 'LUS-guided follow-up', 'loop diuretics', 'Lung ultrasound (LUS', 'LUS']","['number of decompensations and improved walking capacity', 'number of urgent visits for worsening HF', 'mean\u2009±\u2009SD left ventricular ejection fraction', 'composite of urgent visit, hospitalization for worsening HF and death', 'distance achieved in the 6-min walking test', 'N-terminal pro-B-type natriuretic peptide reduction', 'hazard ratio', 'mean\u2009±\u2009standard deviation (SD']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C4286019', 'cui_str': 'Lung ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0445022', 'cui_str': 'Loop (qualifier value)'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0231187', 'cui_str': 'Decompensation (finding)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C1704447', 'cui_str': 'Patient visit for (contextual qualifier) (qualifier value)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction (observable entity)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0754710', 'cui_str': 'Amino-terminal pro-brain natriuretic peptide'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}]",123.0,0.137983,"LUS is a non-invasive, safe and easy-to-use technique with potential clinical applicability to guide pulmonary congestion treatment in patients with HF.","[{'ForeName': 'Mercedes', 'Initials': 'M', 'LastName': 'Rivas-Lasarte', 'Affiliation': 'Cardiology Department, Hospital de la Santa Creu i Sant Pau, IIb-SantPau, CIBERCV, Universitat Autónoma de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Álvarez-García', 'Affiliation': 'Cardiology Department, Hospital de la Santa Creu i Sant Pau, IIb-SantPau, CIBERCV, Universitat Autónoma de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Fernández-Martínez', 'Affiliation': 'Cardiology Department, Hospital de la Santa Creu i Sant Pau, IIb-SantPau, CIBERCV, Universitat Autónoma de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Alba', 'Initials': 'A', 'LastName': 'Maestro', 'Affiliation': 'Cardiology Department, Hospital de la Santa Creu i Sant Pau, IIb-SantPau, CIBERCV, Universitat Autónoma de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'López-López', 'Affiliation': 'Cardiology Department, Hospital de la Santa Creu i Sant Pau, IIb-SantPau, CIBERCV, Universitat Autónoma de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Eduard', 'Initials': 'E', 'LastName': 'Solé-González', 'Affiliation': 'Cardiology Department, Hospital de la Santa Creu i Sant Pau, IIb-SantPau, CIBERCV, Universitat Autónoma de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Maria J', 'Initials': 'MJ', 'LastName': 'Pirla', 'Affiliation': 'Cardiology Department, Hospital de la Santa Creu i Sant Pau, IIb-SantPau, CIBERCV, Universitat Autónoma de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Mesado', 'Affiliation': 'Cardiology Department, Hospital de la Santa Creu i Sant Pau, IIb-SantPau, CIBERCV, Universitat Autónoma de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Mirabet', 'Affiliation': 'Cardiology Department, Hospital de la Santa Creu i Sant Pau, IIb-SantPau, CIBERCV, Universitat Autónoma de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Fluvià', 'Affiliation': 'Cardiology Department, Hospital de la Santa Creu i Sant Pau, IIb-SantPau, CIBERCV, Universitat Autónoma de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Vicens', 'Initials': 'V', 'LastName': 'Brossa', 'Affiliation': 'Cardiology Department, Hospital de la Santa Creu i Sant Pau, IIb-SantPau, CIBERCV, Universitat Autónoma de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Sionis', 'Affiliation': 'Cardiology Department, Hospital de la Santa Creu i Sant Pau, IIb-SantPau, CIBERCV, Universitat Autónoma de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Eulàlia', 'Initials': 'E', 'LastName': 'Roig', 'Affiliation': 'Cardiology Department, Hospital de la Santa Creu i Sant Pau, IIb-SantPau, CIBERCV, Universitat Autónoma de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Cinca', 'Affiliation': 'Cardiology Department, Hospital de la Santa Creu i Sant Pau, IIb-SantPau, CIBERCV, Universitat Autónoma de Barcelona, Barcelona, Spain.'}]",European journal of heart failure,['10.1002/ejhf.1604']
785,30274549,Effect of exercise order with barbell and machine modalities on upper body volume load and myoelectric activity.,"The purpose of this study was to investigate the influence of exercise order on volume load (VL) and myoelectric activation (EMG) during the bench press (BP), military press (MP) and close-grip bench press (CGBP) exercises executed with a barbell and Smith machine. Twelve men experienced in resistance training performed four different exercise sessions in randomised order. Each session consisted of four sets of a given exercise order: O1 = CGBP + MP + BP with barbell; O2 = inverse O1 with barbell, O3 = same O1 with Smith Machine; O4 = same O2 with Smith machine. EMG was assessed for the Clavicular head  pectoralis major  (PMC), anterior  deltoid  (AD),  triceps brachii  long head (TBLH) and  biceps brachii  (BB). Results showed that VL in BP was affected by exercise order, independent of the mode ( p  < 0.05). However, the CGBP showed higher VL in O1. Moreover, when the BP was positioned last in the sequence (O1 and O3), myoelectric activity was higher for PMC, AD and TBLH ( p  < 0.05). Findings were similar in the CGBP (PMC and TBLH), but for the AD (Smith machine > barbell,  p  < 0.05). Therefore, it appears that the order and modes of exercises influence both volume load and myoelectric activation patterns during multiple set of resistance training.",2020,"Results showed that VL in BP was affected by exercise order, independent of the mode (p < 0.05).",['Twelve men experienced in resistance training'],"['exercise order with barbell and machine modalities', 'CGBP\xa0+\xa0MP\xa0+\xa0BP with barbell; O2\xa0=\xa0inverse O1 with barbell, O3\xa0=\xa0same O1 with Smith Machine; O4\xa0=\xa0same O2 with Smith machine', 'bench press (BP), military press (MP) and close-grip bench press (CGBP) exercises executed with a barbell and Smith machine']","['CGBP (PMC and TBLH', 'sequence (O1 and O3), myoelectric activity', 'volume load (VL) and myoelectric activation (EMG', 'Clavicular head pectoralis major (PMC), anterior deltoid (AD), triceps brachii long head (TBLH) and biceps brachii (BB', 'VL in BP', 'upper body volume load and myoelectric activity']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}, {'cui': 'C0336779', 'cui_str': 'Machine, device (physical object)'}, {'cui': 'C0439850', 'cui_str': 'Inverse (qualifier value)'}, {'cui': 'C0554249', 'cui_str': 'Smith (occupation)'}, {'cui': 'C0454326', 'cui_str': 'Bench press (regime/therapy)'}, {'cui': 'C0026126', 'cui_str': 'Armed Forces Personnel'}, {'cui': 'C0587267', 'cui_str': 'Closed (qualifier value)'}, {'cui': 'C0600117', 'cui_str': 'Does grip (finding)'}]","[{'cui': 'C1568303', 'cui_str': 'poly(2-methacryloyloxyethyl phosphorylcholine-co-n-stearyl methacrylate)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C1268087', 'cui_str': 'Upper body'}]",12.0,0.0182716,"Results showed that VL in BP was affected by exercise order, independent of the mode (p < 0.05).","[{'ForeName': 'Ewertton S', 'Initials': 'ES', 'LastName': 'Bezerra', 'Affiliation': 'Human Performance Laboratory, Faculty of Physical Education and Physiotherapy, Federal University of Amazonas , Manaus, Brazil.'}, {'ForeName': 'Brad J', 'Initials': 'BJ', 'LastName': 'Schoenfeld', 'Affiliation': 'Department of Health Sciences, City University of New York , Bronx, NY, USA.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Paz', 'Affiliation': 'School of Physical Education and Sports, Federal University of Rio de Janeiro , Rio de Janeiro, Brazil.'}, {'ForeName': 'Déborah de Araújo', 'Initials': 'DA', 'LastName': 'Farias', 'Affiliation': 'Human Performance Laboratory, Faculty of Physical Education and Physiotherapy, Federal University of Amazonas , Manaus, Brazil.'}, {'ForeName': 'Raphael L', 'Initials': 'RL', 'LastName': 'Sakugawa', 'Affiliation': 'Center of Sports, Federal University of Santa Catarina , Florianópolis, Brazil.'}, {'ForeName': 'Iago', 'Initials': 'I', 'LastName': 'Vieira', 'Affiliation': 'Human Performance Laboratory, Faculty of Physical Education and Physiotherapy, Federal University of Amazonas , Manaus, Brazil.'}, {'ForeName': 'Mateus', 'Initials': 'M', 'LastName': 'Rossato', 'Affiliation': 'Human Performance Laboratory, Faculty of Physical Education and Physiotherapy, Federal University of Amazonas , Manaus, Brazil.'}, {'ForeName': 'Humberto', 'Initials': 'H', 'LastName': 'Miranda', 'Affiliation': 'School of Physical Education and Sports, Federal University of Rio de Janeiro , Rio de Janeiro, Brazil.'}]",Sports biomechanics,['10.1080/14763141.2018.1515980']
786,31675538,PPARG and FTO polymorphism can modulate the outcomes of a central European diet and a Mediterranean diet in centrally obese postmenopausal women.,"The aim of this study was to test the hypothesis that polymorphism of genes with the biggest effects on body mass (FTO and PPARG) can affect the results of dieting in centrally obese postmenopausal women. A total of 144 volunteers were randomized to a 16-week intervention with two hypocaloric diets: either a Mediterranean diet (MED) moderate in fat (37% total energy as fat) or the Central European diet (CED) moderate in carbohydrates (55% total energy as carbohydrates). The associations between FTO and PPARG polymorphism on the baseline body mass, body composition, blood pressure, lipid and non-lipid parameters, and their changes after the trial were analyzed. None of the examined baseline outcomes differed in the rs9939609 FTO subgroups; abdominal fat was higher in the minor (G) allele carriers of the PPARG rs1801282. After the intervention, in the CED group, the PPARG G allele carriers showed greater reductions in weight (-6.58 ± 0.61 vs -9.58 ± 0.83; P < .01), lean mass (-0.38 ± 0.29 vs -1.79 ± 0.38; P < .05) and high-density lipoprotein (HDL) cholesterol (-0.46 ± 0.77 vs -5.25 ± 1.49; P < .01) than the CC homozygotes, and the TT individuals of the rs9939609 FTO had greater reductions in diastolic blood pressure (-9.03 ± 1.78 vs. -7.58 ± 1.50; P < .05). In the MED group, greater reductions in abdominal fat were observed in the G allele carriers than in the CC homozygotes (-3.31 ± 0.26 vs. -4.23 ± 0.41; P < .05). PPARG and FTO polymorphism may affect the outcomes of the diets aimed at weight reduction in postmenopausal women.",2019,"In the MED group, greater reductions in abdominal fat were observed in the G allele carriers than in the CC homozygotes (-3.31 ± 0.26 vs. -4.23 ± 0.41; P < .05).","['centrally obese postmenopausal women', 'postmenopausal women', '144 volunteers']","['hypocaloric diets: either a Mediterranean diet (MED) moderate in fat (37% total energy as fat) or the Central European diet (CED) moderate in carbohydrates (55% total energy as carbohydrates', 'Mediterranean diet']","['abdominal fat', 'rs9939609 FTO subgroups; abdominal fat', 'diastolic blood pressure', 'high-density lipoprotein (HDL) cholesterol', 'lean mass', 'baseline body mass, body composition, blood pressure, lipid and non-lipid parameters', 'weight']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}]","[{'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C1138412', 'cui_str': 'Diet, Mediterranean'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0439175', 'cui_str': '% of total (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}]","[{'cui': 'C1563742', 'cui_str': 'Abdominal Fat'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0023822', 'cui_str': 'High Density Lipoprotein Cholesterol'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}]",144.0,0.0280082,"In the MED group, greater reductions in abdominal fat were observed in the G allele carriers than in the CC homozygotes (-3.31 ± 0.26 vs. -4.23 ± 0.41; P < .05).","[{'ForeName': 'Agata', 'Initials': 'A', 'LastName': 'Chmurzynska', 'Affiliation': 'Institute of Human Nutrition and Dietetics, Poznan University of Life Sciences, Wojska Polskiego 31, 60-624 Poznan, Poland.'}, {'ForeName': 'Agata', 'Initials': 'A', 'LastName': 'Muzsik', 'Affiliation': 'Institute of Human Nutrition and Dietetics, Poznan University of Life Sciences, Wojska Polskiego 31, 60-624 Poznan, Poland.'}, {'ForeName': 'Patrycja', 'Initials': 'P', 'LastName': 'Krzyżanowska-Jankowska', 'Affiliation': 'First Subdepartment of Pediatrics, Department of Pediatric Gastroenterology and Metabolism, Poznan University of Medical Sciences, Szpitalna 27/33, 60-572 Poznan, Poland.'}, {'ForeName': 'Edyta', 'Initials': 'E', 'LastName': 'Mądry', 'Affiliation': 'First Subdepartment of Pediatrics, Department of Pediatric Gastroenterology and Metabolism, Poznan University of Medical Sciences, Szpitalna 27/33, 60-572 Poznan, Poland.'}, {'ForeName': 'Jarosław', 'Initials': 'J', 'LastName': 'Walkowiak', 'Affiliation': 'First Subdepartment of Pediatrics, Department of Pediatric Gastroenterology and Metabolism, Poznan University of Medical Sciences, Szpitalna 27/33, 60-572 Poznan, Poland.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Bajerska', 'Affiliation': 'Institute of Human Nutrition and Dietetics, Poznan University of Life Sciences, Wojska Polskiego 31, 60-624 Poznan, Poland. Electronic address: joanna.bajerska@up.poznan.pl.'}]","Nutrition research (New York, N.Y.)",['10.1016/j.nutres.2019.08.005']
787,31568799,Novel UL97 drug resistance mutations identified at baseline in a clinical trial of maribavir for resistant or refractory cytomegalovirus infection.,"In a Phase 2 clinical trial, 120 subjects with cytomegalovirus (CMV) infection refractory or resistant to standard therapy were randomized equally to 3 doses of oral maribavir treatment, and 70% achieved undetectable plasma CMV DNA within 12 weeks. At study entry, standard diagnostic UL97 genotyping was available for 71 subjects, with 60 (85%) revealing well-characterized ganciclovir resistance mutations that did not preclude a therapeutic response to maribavir. Central laboratory testing of a range of UL97 codons (288-468) not fully covered by standard genotyping was done on 93 subjects at baseline. This detected no previously known maribavir resistance mutations, but identified atypical mutations in 3 subjects, including a P-loop substitution F342Y, and ATP-binding region substitutions K359E/Q. By recombinant phenotyping, K359E and K359Q each conferred a nearly 4-fold increased ganciclovir 50% inhibitory concentration (EC50) without maribavir resistance, whereas F342Y conferred a 6-fold increased ganciclovir EC50 and a 4.5-fold increased maribavir EC50. The subject with F342Y detected at baseline did not achieve plasma CMV DNA clearance after 12 weeks of maribavir therapy and later developed an additional UL97 substitution H411Y known to confer 12- to 20-fold increased MBV EC50 by itself. The combination of F342Y and H411Y was shown to increase the maribavir EC50 by 56-fold. Diagnostic genotyping of UL97 should be expanded to cover the ATP-binding region beginning at codon 335 to enable the detection of atypical resistance mutations and further correlation of their clinical significance.",2019,The combination of F342Y and H411Y was shown to increase the maribavir EC50 by 56-fold.,"['71 subjects, with 60 (85%) revealing well-characterized ganciclovir resistance mutations that did not preclude a therapeutic response to maribavir', '120 subjects with cytomegalovirus (CMV) infection refractory or resistant to standard therapy']",['UL97 codons'],"['MBV EC50', 'maribavir EC50', 'plasma CMV DNA clearance']","[{'cui': 'C0443289', 'cui_str': 'Revealed (qualifier value)'}, {'cui': 'C3875152', 'cui_str': 'Characterizes'}, {'cui': 'C0017066', 'cui_str': 'Ganciclovir'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0521982', 'cui_str': 'Therapeutic response, function (observable entity)'}, {'cui': 'C1508759', 'cui_str': 'maribavir'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0010823', 'cui_str': 'Salivary Gland Virus Disease'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0009221', 'cui_str': 'Codon'}]","[{'cui': 'C1508759', 'cui_str': 'maribavir'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}]",120.0,0.0455351,The combination of F342Y and H411Y was shown to increase the maribavir EC50 by 56-fold.,"[{'ForeName': 'Sunwen', 'Initials': 'S', 'LastName': 'Chou', 'Affiliation': 'Division of Infectious Diseases, Oregon Health and Science University, Department of Veterans Affairs Medical Center, Portland, Oregon, USA. Electronic address: chous@ohsu.edu.'}, {'ForeName': 'Jingyang', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Shire, a Takeda Company, Lexington, MA, USA.'}, {'ForeName': 'Kening', 'Initials': 'K', 'LastName': 'Song', 'Affiliation': 'Shire, a Takeda Company, Lexington, MA, USA.'}, {'ForeName': 'Tien', 'Initials': 'T', 'LastName': 'Bo', 'Affiliation': 'Shire, a Takeda Company, Lexington, MA, USA.'}]",Antiviral research,['10.1016/j.antiviral.2019.104616']
788,28847455,"Reductions in cannabis use are associated with improvements in anxiety, depression, and sleep quality, but not quality of life.","AIMS


This study examined the longitudinal association between reductions in cannabis use and changes in anxiety, depression, sleep quality, and quality of life.
METHODS


Secondary analyses were conducted based on data from a cannabis use disorder medication trial in 302 adults (ages 18-50). Changes in symptoms of anxiety and depression, sleep quality, and quality of life were assessed in relation to changes in cannabis use during the 12-week trial of treatment.
RESULTS


Based on the slope of individual cannabis use trajectory, the sample was classified into two groups (Cannabis Use Reduction, n=152 vs. Cannabis Use Increase, n=150) which was included as a binary covariate in subsequent modeling. Controlling for demographics (age, gender, race/ethnicity), treatment condition, and time-varying tobacco and alcohol use, separate latent growth curve models showed a significant association between the Cannabis Use Reduction group and improvement (i.e., lower values in slope) in anxiety (β=-0.09, SE=0.04; p<0.05), depression (β=-0.11, SE=0.04; p<0.01), and sleep quality (β=-0.07, SE=0.03; p<0.05) over the observation period, but not in quality of life.
CONCLUSIONS


These results indicate a longitudinal relationship between reductions in cannabis use and improvements in anxiety, depression, and sleep quality. Clinicians treating patients with co-occurring cannabis use and problems with anxiety, depression, or sleep quality should attend to cannabis use reduction as a component of treatment.",2017,"Changes in symptoms of anxiety and depression, sleep quality, and quality of life were assessed in relation to changes in cannabis use during the 12-week trial of treatment.
",['Secondary analyses were conducted based on data from a cannabis use disorder medication trial in 302 adults (ages 18-50'],[],"['anxiety, depression, and sleep quality', 'symptoms of anxiety and depression, sleep quality, and quality of life', 'depression', 'anxiety, depression, sleep quality, and quality of life', 'quality of life', 'sleep quality', 'anxiety']","[{'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3160814', 'cui_str': 'Cannabis use'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]",[],"[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034380'}]",302.0,0.0270689,"Changes in symptoms of anxiety and depression, sleep quality, and quality of life were assessed in relation to changes in cannabis use during the 12-week trial of treatment.
","[{'ForeName': 'Yih-Ing', 'Initials': 'YI', 'LastName': 'Hser', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, University of California Los Angeles, United States. Electronic address: yhser@ucla.edu.'}, {'ForeName': 'Larissa J', 'Initials': 'LJ', 'LastName': 'Mooney', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, University of California Los Angeles, United States. Electronic address: lmooney@mednet.ucla.edu.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Huang', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, University of California Los Angeles, United States. Electronic address: yhuang@ucla.edu.'}, {'ForeName': 'Yuhui', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, University of California Los Angeles, United States. Electronic address: yhzhu@ucla.edu.'}, {'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'Tomko', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, United States. Electronic address: tomko@musc.edu.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'McClure', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, United States. Electronic address: mccluree@musc.edu.'}, {'ForeName': 'Chih-Ping', 'Initials': 'CP', 'LastName': 'Chou', 'Affiliation': 'Institute of Preventive Medicine, University of Southern California, United States. Electronic address: cchou@usc.edu.'}, {'ForeName': 'Kevin M', 'Initials': 'KM', 'LastName': 'Gray', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, United States. Electronic address: graykm@musc.edu.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2017.07.012']
789,30590726,"Long-term outcomes of patients with stable coronary disease and chronic kidney dysfunction: 10-year follow-up of the Medicine, Angioplasty, or Surgery Study II Trial.","BACKGROUND


Chronic kidney disease (CKD) is associated with a worse prognosis in patients with stable coronary artery disease (CAD); however, there is limited randomized data on long-term outcomes of CAD therapies in these patients. We evaluated long-term outcomes of CKD patients with CAD who underwent randomized therapy with medical treatment (MT) alone, percutaneous coronary intervention (PCI) or coronary artery bypass graft surgery (CABG).
METHODS


Baseline estimated glomerular filtration rate (eGFR) was obtained in 611 patients randomized to one of three therapeutic strategies in the Medicine, Angioplasty, or Surgery Study II trial. Patients were categorized in preserved renal function and mild or moderate CKD groups depending on their eGFR (≥90, 89-60 and 59-30 mL/min/1.73 m2, respectively). The primary clinical endpoint, a composite of overall death and myocardial infarction, and its individual components were analyzed using proportional hazards regression (Clinical Trial registration information: http://www.controlled-trials.com. Registration number: ISRCTN66068876).
RESULTS


Of 611 patients, 112 (18%) had preserved eGFR, 349 (57%) mild dysfunction and 150 (25%) moderate dysfunction. The primary endpoint occurred in 29.5, 32.4 and 44.7% (P = 0.02) for preserved eGFR, mild CKD and moderate CKD, respectively. Overall mortality incidence was 18.7, 23.8 and 39.3% for preserved eGFR, mild CKD and moderate CKD, respectively (P = 0.001). For preserved eGFR, there was no significant difference in outcomes between therapies. For mild CKD, the primary event rate was 29.4% for PCI, 29.1% for CABG and 41.1% for MT (P = 0.006) [adjusted hazard ratio (HR) = 0.26, 95% confidence interval (CI) 0.07-0.88; P = 0.03 for PCI versus MT; and adjusted HR = 0.48; 95% CI 0.31-0.76; P = 0.002 for CABG versus MT]. We also observed higher mortality rates in the MT group (28.6%) compared with PCI (24.1%) and CABG (19.0%) groups (P = 0.015) among mild CKD subjects (adjusted HR = 0.44, 95% CI 0.25-0.76; P = 0.003 for CABG versus MT; adjusted HR = 0.56, 95% CI 0.07-4.28; P = 0.58 for PCI versus MT). Results were similar with moderate CKD group but did not achieve significance.
CONCLUSIONS


Coronary interventional therapy, both PCI and CABG, is associated with lower rates of events compared with MT in mild CKD patients >10 years of follow-up. More study is needed to confirm these benefits in moderate CKD.",2020,"The primary endpoint occurred in 29.5, 32.4 and 44.7% (P = 0.02) for preserved eGFR, mild CKD and moderate CKD, respectively.","['patients with stable coronary disease and chronic kidney dysfunction', 'CKD patients with CAD who underwent', '\n\n\nChronic kidney disease (CKD', '611 patients', 'Patients were categorized in preserved renal function and mild or moderate CKD groups depending on their eGFR (≥90, 89-60 and 59-30', 'patients with stable coronary artery disease (CAD']","['randomized therapy with medical treatment (MT) alone, percutaneous coronary intervention (PCI) or coronary artery bypass graft surgery (CABG']","['glomerular filtration rate (eGFR', 'composite of overall death and myocardial infarction, and its individual components', 'CABG', 'mortality rates', 'moderate dysfunction', 'preserved eGFR, mild CKD and moderate CKD', 'Overall mortality incidence']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0151746', 'cui_str': 'Abnormal renal function (finding)'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}, {'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",611.0,0.296107,"The primary endpoint occurred in 29.5, 32.4 and 44.7% (P = 0.02) for preserved eGFR, mild CKD and moderate CKD, respectively.","[{'ForeName': 'Eduardo Gomes', 'Initials': 'EG', 'LastName': 'Lima', 'Affiliation': 'Department of Clinical Cardiology, Heart Institute (InCor), University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Charytan', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Whady', 'Initials': 'W', 'LastName': 'Hueb', 'Affiliation': 'Department of Clinical Cardiology, Heart Institute (InCor), University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Diogo Freitas Cardoso', 'Initials': 'DFC', 'LastName': 'de Azevedo', 'Affiliation': 'Department of Clinical Cardiology, Heart Institute (InCor), University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Cibele Larrosa', 'Initials': 'CL', 'LastName': 'Garzillo', 'Affiliation': 'Department of Clinical Cardiology, Heart Institute (InCor), University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Desiderio', 'Initials': 'D', 'LastName': 'Favarato', 'Affiliation': 'Department of Clinical Cardiology, Heart Institute (InCor), University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Jaime Paula Pessoa', 'Initials': 'JPP', 'LastName': 'Linhares Filho', 'Affiliation': 'Department of Clinical Cardiology, Heart Institute (InCor), University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Eduardo Bello', 'Initials': 'EB', 'LastName': 'Martins', 'Affiliation': 'Department of Clinical Cardiology, Heart Institute (InCor), University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Daniel Valente', 'Initials': 'DV', 'LastName': 'Batista', 'Affiliation': 'Department of Clinical Cardiology, Heart Institute (InCor), University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Paulo Cury', 'Initials': 'PC', 'LastName': 'Rezende', 'Affiliation': 'Department of Clinical Cardiology, Heart Institute (InCor), University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Alexandre Ciappina', 'Initials': 'AC', 'LastName': 'Hueb', 'Affiliation': 'Department of Clinical Cardiology, Heart Institute (InCor), University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'José Antonio Franchini', 'Initials': 'JAF', 'LastName': 'Ramires', 'Affiliation': 'Department of Clinical Cardiology, Heart Institute (InCor), University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Kalil Filho', 'Affiliation': 'Department of Clinical Cardiology, Heart Institute (InCor), University of São Paulo, São Paulo, Brazil.'}]","Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association",['10.1093/ndt/gfy379']
790,30616601,Randomized prospective phase III trial of  68 Ga-PSMA-11 PET/CT molecular imaging for prostate cancer salvage radiotherapy planning [PSMA-SRT].,"BACKGROUND


Salvage radiotherapy (SRT) for prostate cancer (PCa) recurrence after prostatectomy offers long-term biochemical control in about 50-60% of patients. SRT is commonly initiated in patients with serum PSA levels < 1 ng/mL, a threshold at which standard-of-care imaging is insensitive for detecting recurrence. As such, SRT target volumes are usually drawn in the absence of radiographically visible disease.  68 Ga-PSMA-11 (PSMA) PET/CT molecular imaging is highly sensitive and may offer anatomic localization of PCa biochemical recurrence. However, it is unclear if incorporation of PSMA PET/CT imaging into the planning of SRT could improve its likelihood of success. The purpose of this trial is to evaluate the success rate of SRT for recurrence of PCa after prostatectomy with and without planning based on PSMA PET/CT.
METHODS


We will randomize 193 patients to proceed with standard SRT (control arm 1, n = 90) or undergo a PSMA PET/CT scan (free of charge for patients) prior to SRT planning (investigational arm 2, n = 103). The primary endpoint is the success rate of SRT measured as biochemical progression-free survival (BPFS) after initiation of SRT. Biochemical progression is defined by PSA ≥ 0.2 ng/mL and rising. The randomization ratio of 1:1.13 is based on the assumption that approximately 13% of subjects randomized to Arm 2 will not be treated with SRT because of PSMA-positive extra-pelvic metastases. These patients will not be included in the primary endpoint analysis but will still be followed. The choice of treating the prostate bed alone vs prostate bed and pelvic lymph nodes, with or without androgen deprivation therapy (ADT), is selected by the treating radiation oncologist. The radiation oncologist may change the radiation plan depending on the findings of the PSMA PET/CT scan. Any other imaging is allowed for SRT planning in both arms if done per routine care. Patients will be followed until either one of the following conditions occur: 5 years after the date of initiation of randomization, biochemical progression, diagnosis of metastatic disease, initiation of any additional salvage therapy, death.
DISCUSSION


This is the first randomized phase 3 prospective trial designed to determine whether PSMA PET/CT molecular imaging can improve outcomes in patients with PCa early BCR following radical prostatectomy.
ACRONYM


PSMA-SRT Phase 3 trial.
CLINICAL TRIAL REGISTRATION


■ IND#130649 ◦ Submission: 04.26.2016 ◦ Safe-to-proceed letter issued by FDA: 05.25.2016 ■ UCLA IRB #18-000484, ■ First submission: 3.27.2018 ■ Date of approval: 5.31.2018 ■ UCLA JCCC Short Title NUC MED 18-000484 ■ NCI Trial Identifier NCI-2018-01518 ■ ClinicalTrials.gov Identifier NCT03582774 ■ First Submitted: 06.19.2018 ■ First Submitted that Met QC Criteria: 06.27.2018 ■ First Posted: 07.11.2018 ■ Last Update Submitted that Met QC Criteria: 07.17.2018 ■ Last Update Posted: 07.19.2018 TRIAL STATUS: Current Trial Status Active as of 08/13/2018 Trial Start Date 09/01/2018-Actual Primary Completion Date 09/01/2023-Anticipated Trial Completion Date 09/01/2024-Anticipated.",2019,The primary endpoint is the success rate of SRT measured as biochemical progression-free survival (BPFS) after initiation of SRT.,"['193 patients to proceed with', 'Met QC Criteria', 'patients with PCa early BCR following radical prostatectomy']","['SRT', 'androgen deprivation therapy (ADT', '68 Ga-PSMA-11 PET/CT molecular imaging for prostate cancer salvage radiotherapy planning [PSMA-SRT', 'FDA', '68 Ga-PSMA-11 (PSMA', 'PSMA PET/CT molecular imaging', 'Salvage radiotherapy (SRT', 'standard SRT (control arm 1, n\u2009=\u200990) or undergo a PSMA PET/CT scan (free of charge for patients) prior to SRT planning']","['success rate of SRT measured as biochemical progression-free survival (BPFS', 'Biochemical progression']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0030625', 'cui_str': 'PCA'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy (procedure)'}]","[{'cui': 'C0234742', 'cui_str': 'Speech reception threshold (observable entity)'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy (procedure)'}, {'cui': 'C0303226', 'cui_str': 'Gallium-68'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}, {'cui': 'C1537028', 'cui_str': 'Molecular Imaging'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0442967', 'cui_str': 'Salvage procedure (qualifier value)'}, {'cui': 'C0454111', 'cui_str': 'Radiotherapy planning (procedure)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1699633', 'cui_str': 'Positron Emission Tomography Computed Tomography'}, {'cui': 'C0332296', 'cui_str': 'Free of (attribute)'}, {'cui': 'C0007961', 'cui_str': 'Charges'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}]","[{'cui': 'C0234742', 'cui_str': 'Speech reception threshold (observable entity)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}]",,0.170203,The primary endpoint is the success rate of SRT measured as biochemical progression-free survival (BPFS) after initiation of SRT.,"[{'ForeName': 'Jeremie', 'Initials': 'J', 'LastName': 'Calais', 'Affiliation': 'Department of Molecular & Medical Pharmacology, Ahmanson Translational Theranostics/ Imaging Division, University of California, Los Angeles, USA. jcalais@mednet.ucla.edu.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Czernin', 'Affiliation': 'Department of Molecular & Medical Pharmacology, Ahmanson Translational Theranostics/ Imaging Division, University of California, Los Angeles, USA. jczernin@mednet.ucla.edu.'}, {'ForeName': 'Wolfgang P', 'Initials': 'WP', 'LastName': 'Fendler', 'Affiliation': 'Department of Molecular & Medical Pharmacology, Ahmanson Translational Theranostics/ Imaging Division, University of California, Los Angeles, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Elashoff', 'Affiliation': 'Department of Medicine Statistics Core (DOMStat), UCLA CTSI Biostatistics and Computational Biology, University of California, Los Angeles, USA.'}, {'ForeName': 'Nicholas G', 'Initials': 'NG', 'LastName': 'Nickols', 'Affiliation': 'Department of Radiation Oncology, University of California, Los Angeles, USA.'}]",BMC cancer,['10.1186/s12885-018-5200-1']
791,29146120,Depressive symptoms and glycemic control in youth with type 2 diabetes participating in the TODAY clinical trial.,"The relationship between depressive symptoms and glycemic control in youth with type 2 diabetes was assessed at baseline (n = 682), 6, and/or 24 months (n = 576). Neither baseline nor persistence of depressive symptoms was significantly associated with maintenance of glycemic control. Nevertheless, depressive symptoms were common, suggesting the importance of repeated screening.",2018,Neither baseline nor persistence of depressive symptoms was significantly associated with maintenance of glycemic control.,"['youth with type 2 diabetes', 'youth with type 2 diabetes participating']",[],"['Depressive symptoms and glycemic control', 'depressive symptoms']","[{'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]",[],"[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",,0.118499,Neither baseline nor persistence of depressive symptoms was significantly associated with maintenance of glycemic control.,"[{'ForeName': 'Dorothy J', 'Initials': 'DJ', 'LastName': 'Van Buren', 'Affiliation': 'Washington University School of Medicine, USA.'}, {'ForeName': 'Denise E', 'Initials': 'DE', 'LastName': 'Wilfley', 'Affiliation': 'Washington University School of Medicine, USA.'}, {'ForeName': 'Marsha D', 'Initials': 'MD', 'LastName': 'Marcus', 'Affiliation': 'University of Pittsburgh School of Medicine, USA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Anderson', 'Affiliation': 'Baylor College of Medicine, USA.'}, {'ForeName': 'Natalie Walders', 'Initials': 'NW', 'LastName': 'Abramson', 'Affiliation': 'Department of Pediatrics, University of Colorado School of Medicine, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Berkowitz', 'Affiliation': 'University of Pennsylvania, USA.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Ievers-Landis', 'Affiliation': 'Case Western Reserve University School of Medicine, USA.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Trief', 'Affiliation': 'SUNY Upstate Medical University, USA.'}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Yasuda', 'Affiliation': ""Children's Hospital Los Angeles, USA.""}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Hirst', 'Affiliation': 'George Washington University Biostatistics Center, USA. Electronic address: today@bsc.gwu.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes research and clinical practice,['10.1016/j.diabres.2017.11.008']
792,24465565,The effect of exercise intensity on endothelial function in physically inactive lean and obese adults.,"PURPOSE


To examine the effects of exercise intensity on acute changes in endothelial function in lean and obese adults.
METHODS


Sixteen lean (BMI <25, age 23 ± 3 yr) and 10 obese (BMI >30, age 26 ± 6 yr) physically inactive adults were studied during 3 randomized admissions [control (C, no exercise), moderate-intensity exercise (M, @ lactate threshold (LT)) and high-intensity exercise (H, midway between LT and VO2peak) (30 min)]. Endothelial function was assessed by flow-mediated dilation (FMD) at baseline and 1, 2, and 4 h post-exercise.
RESULTS


RM ANCOVA revealed significant main effects for group, time, and group x condition interaction (p<0.05). A diurnal increase in FMD was observed in lean but not obese subjects. Lean subjects exhibited greater increases in FMD than obese subjects (p = 0.0005). In the obese group a trend was observed for increases in FMD at 2- and 4-hr after M (p = 0.08). For lean subjects, FMD was significantly elevated at all time points after H. The increase in FMD after H in lean subjects (3.2 ± 0.5%) was greater than after both C (1.7 ± 0.4%, p = 0.015) and M (1.4 ± 0.4%, p = 0.002). FMD responses of lean and obese subjects significantly differed after C and H, but not after M.
CONCLUSION


In lean young adults, high-intensity exercise acutely enhances endothelial function, while moderate-intensity exercise has no significant effect above that seen in the absence of exercise. The FMD response of obese adults is blunted compared to lean adults. Diurnal variation should be considered when examining the effects of acute exercise on FMD.",2014,Lean subjects exhibited greater increases in FMD than obese subjects (p = 0.0005).,"['physically inactive lean and obese adults', 'lean and obese adults', 'physically inactive adults', 'Sixteen lean (BMI <25, age 23 ± 3 yr) and 10 obese (BMI >30, age 26 ± 6 yr', 'lean young adults']","['admissions [control (C, no exercise), moderate-intensity exercise (M, @ lactate threshold (LT)) and high-intensity exercise', 'exercise intensity']","['FMD', 'FMD response', 'endothelial function', 'Endothelial function', 'FMD responses']","[{'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}]","[{'cui': 'C0031843', 'cui_str': 'function'}]",,0.0801212,Lean subjects exhibited greater increases in FMD than obese subjects (p = 0.0005).,"[{'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Hallmark', 'Affiliation': 'Department of Human Services, University of Virginia, Charlottesville, Virginia, United States of America.'}, {'ForeName': 'James T', 'Initials': 'JT', 'LastName': 'Patrie', 'Affiliation': 'Department of Public Health Sciences, University of Virginia, Charlottesville, Virginia, United States of America.'}, {'ForeName': 'Zhenqi', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Department of Medicine, University of Virginia, Charlottesville, Virginia, United States of America.'}, {'ForeName': 'Glenn A', 'Initials': 'GA', 'LastName': 'Gaesser', 'Affiliation': 'Department of Human Services, University of Virginia, Charlottesville, Virginia, United States of America.'}, {'ForeName': 'Eugene J', 'Initials': 'EJ', 'LastName': 'Barrett', 'Affiliation': 'Department of Medicine, University of Virginia, Charlottesville, Virginia, United States of America ; General Clinical Research Center, University of Virginia, Charlottesville, Virginia, United States of America.'}, {'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'Weltman', 'Affiliation': 'Department of Human Services, University of Virginia, Charlottesville, Virginia, United States of America ; Department of Medicine, University of Virginia, Charlottesville, Virginia, United States of America ; General Clinical Research Center, University of Virginia, Charlottesville, Virginia, United States of America.'}]",PloS one,['10.1371/journal.pone.0085450']
793,28505317,Comparative assessment of conventional and light-curable fluoride varnish in the prevention of enamel demineralization during fixed appliance therapy: a split-mouth randomized controlled trial.,"Objective


To evaluate the effects of single application of a conventional versus light-curable fluoride varnish (LCFV) on prevention of enamel demineralization during fixed orthodontic treatment over a 4 month period.
Design


The research was designed as a split-mouth, randomized control trial (RCT).
Methods


Twenty-two patients requiring fixed orthodontic treatment with premolar extractions were included in the RCT. In each patient, two diagonal quadrants (i.e. upper right and lower left, or vice versa) were randomly assigned to receive conventional fluoride varnish or LCFV. After allocation of one intervention, the other diagonal quadrants received the second intervention. At specific time intervals, premolars were extracted and sectioned, and the demineralized lesion was assessed in each group.
Main outcome measures


The primary outcome was demineralized enamel lesion depth (DELD) at the end of 45, 90, and 120 days.
Randomization


A simple complete randomization list using random allocation rule (restricted randomization) was computer generated to ensure homogeneity of application of conventional or LCFV to each contralateral quadrant in a split-mouth design. Allocation concealment was not employed.
Blinding


Blinding was done only for outcome assessor because of clinical limitations.
Results


Twenty-two patients with 88 teeth were enrolled in the trial. After excluding the drop-outs, primary analysis was performed on 66 teeth distributed among two interventional groups. Mean difference between DELD among two groups was 36.6 µm [95 per cent confidence interval (CI) 34.61-38.55] and 58.5 µm [95 per cent confidence interval (CI) 55.65-61.43] at 90 and 120 days, respectively. Cluster level analysis performed by Paired t-test showed that DELD was significantly higher (P < 0.001) in the conventional fluoride varnish group at the end of 90 and 120 days as compared to LCFV group. No adverse effect was observed in any patient.
Limitations


Being a histologic study, the role of fluoride varnish could be assessed only for 4 months.
Conclusion


The result of this study indicate that single application of LCFV (Clinpro™ XT) can prevent enamel demineralization for longer duration (for up to 4 months) of time as compared to conventional fluoride varnish (Duraphat™, 45 days) during fixed appliance therapy.
Registration


The trial was registered retrospectively in the Clinical Trial Registry-India, number CTRI/2016/09/007232.",2018,Cluster level analysis performed by Paired t-test showed that DELD was significantly higher (P < 0.001) in the conventional fluoride varnish group at the end of 90 and 120 days as compared to LCFV group.,"['Results\n\n\nTwenty-two patients with 88 teeth were enrolled in the trial', 'Methods\n\n\nTwenty-two patients requiring fixed orthodontic treatment with premolar extractions']","['conventional fluoride varnish or LCFV', 'conventional versus light-curable fluoride varnish (LCFV', 'LCFV (Clinpro™ XT', 'fluoride varnish', 'conventional fluoride varnish', 'conventional and light-curable fluoride varnish']","['enamel demineralization', 'DELD', 'demineralized enamel lesion depth (DELD', 'adverse effect']","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C4284772', 'cui_str': '22 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0040426', 'cui_str': 'Tooth'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0029335', 'cui_str': 'Orthodontics'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1704302', 'cui_str': 'Premolar'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0016326', 'cui_str': 'Fluoride Varnishes'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}]","[{'cui': 'C0011350', 'cui_str': 'Enamel'}, {'cui': 'C0700185', 'cui_str': 'Demineralized structure'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",66.0,0.325051,Cluster level analysis performed by Paired t-test showed that DELD was significantly higher (P < 0.001) in the conventional fluoride varnish group at the end of 90 and 120 days as compared to LCFV group.,"[{'ForeName': 'Mandar', 'Initials': 'M', 'LastName': 'Shah', 'Affiliation': 'Department of Orthodontics and Dentofacial Orthopedics, H.K.E.S, SN Dental College, Gulbarga, Karnataka, India.'}, {'ForeName': 'Ganesh', 'Initials': 'G', 'LastName': 'Paramshivam', 'Affiliation': 'Department of Orthodontics and Dentofacial Orthopedics, H.K.E.S, SN Dental College, Gulbarga, Karnataka, India.'}, {'ForeName': 'Anurag', 'Initials': 'A', 'LastName': 'Mehta', 'Affiliation': 'Department of Orthodontics and Dentofacial Orthopedics, Vyas Dental College & Hospital, Jodhpur, Rajasthan, India.'}, {'ForeName': 'Surjit', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': 'Department of Pharmacology, All India Institute of Medical Sciences, Jodhpur, Rajasthan, India.'}, {'ForeName': 'Ankita', 'Initials': 'A', 'LastName': 'Chugh', 'Affiliation': 'Department of Dentistry, All India Institute of Medical Sciences, Jodhpur, Rajasthan, India.'}, {'ForeName': 'Anil', 'Initials': 'A', 'LastName': 'Prashar', 'Affiliation': 'Department of Orthodontics and Dentofacial Orthopedics, Desh Bhagat Dental College, Muktsar & Hospital, Punjab, India.'}, {'ForeName': 'Vinay Kumar', 'Initials': 'VK', 'LastName': 'Chugh', 'Affiliation': 'Department of Dentistry, All India Institute of Medical Sciences, Jodhpur, Rajasthan, India.'}]",European journal of orthodontics,['10.1093/ejo/cjx037']
794,30304425,Effect of Immediate vs Delayed Pushing on Rates of Spontaneous Vaginal Delivery Among Nulliparous Women Receiving Neuraxial Analgesia: A Randomized Clinical Trial.,"Importance


It is unclear whether the timing of second stage pushing efforts affects spontaneous vaginal delivery rates and reduces morbidities.
Objective


To evaluate whether immediate or delayed pushing results in higher rates of spontaneous vaginal delivery and lower rates of maternal and neonatal morbidities.
Design, Setting, and Participants


Pragmatic randomized clinical trial of nulliparous women at or beyond 37 weeks' gestation admitted for spontaneous or induced labor with neuraxial analgesia between May 2014 and December 2017 at 6 US medical centers. The interim analysis suggested futility for the primary outcome and recruitment was terminated with 2414 of 3184 planned participants. Follow-up ended January 4, 2018.
Interventions


Randomization occurred when participants reached complete cervical dilation. Immediate group participants (n = 1200) began pushing immediately. Delayed group participants (n = 1204) were instructed to wait 60 minutes.
Main Outcomes and Measures


The primary outcome was spontaneous vaginal delivery. Secondary outcomes included total duration of the second stage, duration of active pushing, operative vaginal delivery, cesarean delivery, postpartum hemorrhage, chorioamnionitis, endometritis, perineal lacerations (≥second degree), and a composite outcome of neonatal morbidity that included neonatal death and 9 other adverse outcomes.
Results


Among 2414 women randomized (mean age, 26.5 years), 2404 (99.6%) completed the trial. The rate of spontaneous vaginal delivery was 85.9% in the immediate group vs 86.5% in the delayed group, and was not significantly different (absolute difference, -0.6% [95% CI, -3.4% to 2.1%]; relative risk, 0.99 [95% CI, 0.96 to 1.03]). There was no significant difference in 5 of the 9 prespecified secondary outcomes reported, including the composite outcome of neonatal morbidity (7.3% for the immediate group vs 8.9% for the delayed group; between-group difference, -1.6% [95% CI, -3.8% to 0.5%]) and perineal lacerations (45.9% vs 46.4%, respectively; between-group difference, -0.4% [95% CI, -4.4% to 3.6%]). The immediate group had significantly shorter mean duration of the second stage compared with the delayed group (102.4 vs 134.2 minutes, respectively; mean difference, -31.8 minutes [95% CI, -36.7 to -26.9], P < .001), despite a significantly longer mean duration of active pushing (83.7 vs 74.5 minutes; mean difference, 9.2 minutes [95% CI, 5.8 to 12.6], P < .001), lower rates of chorioamnionitis (6.7% vs 9.1%; between-group difference, -2.5% [95% CI, -4.6% to -0.3%], P = .005), and fewer postpartum hemorrhages (2.3% vs 4.0%; between-group difference, -1.7% [95% CI, -3.1% to -0.4%], P = .03).
Conclusions and Relevance


Among nulliparous women receiving neuraxial anesthesia, the timing of second stage pushing efforts did not affect the rate of spontaneous vaginal delivery. These findings may help inform decisions about the preferred timing of second stage pushing efforts, when considered with other maternal and neonatal outcomes.
Trial Registration


ClinicalTrials.gov Identifier: NCT02137200.",2018,"The rate of spontaneous vaginal delivery was 85.9% in the immediate group vs 86.5% in the delayed group, and was not significantly different (absolute difference, -0.6% [95% CI, -3.4% to 2.1%]; relative risk, 0.99","['2414 women randomized (mean age, 26.5 years), 2404 (99.6%) completed the trial', ""nulliparous women at or beyond 37 weeks' gestation admitted for spontaneous or induced labor with neuraxial analgesia between May 2014 and December 2017 at 6 US medical centers"", 'Nulliparous Women Receiving Neuraxial Analgesia', 'nulliparous women receiving']","['neuraxial anesthesia', 'Immediate vs Delayed Pushing']","['total duration of the second stage, duration of active pushing, operative vaginal delivery, cesarean delivery, postpartum hemorrhage, chorioamnionitis, endometritis, perineal lacerations (≥second degree), and a composite outcome of neonatal morbidity that included neonatal death and 9 other adverse outcomes', 'mean duration of active pushing', 'Rates of Spontaneous Vaginal Delivery', 'spontaneous vaginal delivery', 'perineal lacerations', 'composite outcome of neonatal morbidity', 'complete cervical dilation', 'lower rates of chorioamnionitis', 'rate of spontaneous vaginal delivery', 'postpartum hemorrhages', 'shorter mean duration of the second stage']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0425979', 'cui_str': 'Nulliparous (finding)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}]","[{'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C1719958', 'cui_str': 'Push'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0566690', 'cui_str': 'Vaginal delivery (finding)'}, {'cui': 'C1384674', 'cui_str': 'Deliveries by cesarean (finding)'}, {'cui': 'C0032797', 'cui_str': 'Postpartum Hemorrhage'}, {'cui': 'C0008495', 'cui_str': 'Chorioamnionitis'}, {'cui': 'C0014179', 'cui_str': 'Endometritis'}, {'cui': 'C0240713', 'cui_str': 'Laceration of perineum (disorder)'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0410916', 'cui_str': 'Neonatal Death'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1384485', 'cui_str': 'Delivery normal (finding)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}]",2414.0,0.370733,"The rate of spontaneous vaginal delivery was 85.9% in the immediate group vs 86.5% in the delayed group, and was not significantly different (absolute difference, -0.6% [95% CI, -3.4% to 2.1%]; relative risk, 0.99","[{'ForeName': 'Alison G', 'Initials': 'AG', 'LastName': 'Cahill', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medicine, Washington University in St Louis, St Louis, Missouri.'}, {'ForeName': 'Sindhu K', 'Initials': 'SK', 'LastName': 'Srinivas', 'Affiliation': 'Department of Obstetrics and Gynecology, Perelman School of Medicine, Maternal and Child Health Research Center, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Alan T N', 'Initials': 'ATN', 'LastName': 'Tita', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Alabama, Birmingham.'}, {'ForeName': 'Aaron B', 'Initials': 'AB', 'LastName': 'Caughey', 'Affiliation': 'Department of Obstetrics and Gynecology, Oregon Health & Science University, Portland.'}, {'ForeName': 'Holly E', 'Initials': 'HE', 'LastName': 'Richter', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Alabama, Birmingham.'}, {'ForeName': 'W Thomas', 'Initials': 'WT', 'LastName': 'Gregory', 'Affiliation': 'Department of Obstetrics and Gynecology, Oregon Health & Science University, Portland.'}, {'ForeName': 'Jingxia', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Division of Public Health Sciences, School of Medicine, Washington University in St Louis, St Louis, Missouri.'}, {'ForeName': 'Candice', 'Initials': 'C', 'LastName': 'Woolfolk', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medicine, Washington University in St Louis, St Louis, Missouri.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Weinstein', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medicine, Washington University in St Louis, St Louis, Missouri.'}, {'ForeName': 'Amit M', 'Initials': 'AM', 'LastName': 'Mathur', 'Affiliation': 'Department of Pediatrics, School of Medicine, Washington University in St Louis, St Louis, Missouri.'}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Macones', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medicine, Washington University in St Louis, St Louis, Missouri.'}, {'ForeName': 'Methodius G', 'Initials': 'MG', 'LastName': 'Tuuli', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medicine, Washington University in St Louis, St Louis, Missouri.'}]",JAMA,['10.1001/jama.2018.13986']
795,31661171,A randomized comparison of manual pressure versus figure-of-eight suture for hemostasis after cryoballoon ablation for atrial fibrillation.,"INTRODUCTION


Cryoballoon ablation is commonly used to treat atrial fibrillation (AF). Femoral vein hemostasis after cryoballoon ablation for AF is routinely achieved with manual pressure (MP) after reversal of heparin and reassessment of the activated clotting time, or with a figure-of-eight suture (F8). The purpose of this randomized trial was to compare these two techniques for femoral vein hemostasis after cryoballoon ablation for AF in a patient population predominantly on novel anticoagulants (NOAC).
METHODS AND RESULTS


Seventy consecutive patients who underwent cryoballoon ablation were randomized to either the MP or F8 for femoral vein hemostasis. Clinical and procedural characteristics were similar between the groups with the majority of patients treated with a NOAC. The total time in the electrophysiology laboratory for the MP group and the F8 group (197 ± 37 minutes vs 167 ± 36 minutes, respectively; P = .02), and the time from sheath removal until the patient left the laboratory (28 ± 9 minutes vs 20 ± 5 minutes, respectively; P < .0001) were significantly less in the F8 group. Additional pressure for hemostasis in the recovery suite was required more often in the MP Group, as opposed to the F8 group (29% vs 3%; P = .003). No major bleeding occurred and the rate of minor hematomas was statistically similar.
CONCLUSIONS


Hemostasis obtained with a F8 suture after cryoballoon ablation for AF is associated with significantly less patient time in the electrophysiology laboratory, and an improved safety profile, compared with manual hemostasis, even amongst patients treated with a NOAC.",2019,"CONCLUSIONS


Hemostasis obtained with a F8 suture after cryoballoon ablation for AF is associated with significantly less patient time in the electrophysiology laboratory, and an improved safety profile, compared to manual hemostasis, even amongst patients treated with a NOAC.","['AF in a patient population predominantly on novel anticoagulants (NOAC', 'Seventy consecutive patients who underwent cryoballoon ablation', 'Atrial Fibrillation']","['femoral vein hemostasis after cryoballoon ablation', 'MP or F8 for femoral vein hemostasis', 'Manual Pressure versus Figure of Eight Suture for Hemostasis after Cryoballoon Ablation']","['total time', 'rate of minor hematomas', 'major bleeding', 'Additional pressure for hemostasis', 'time from sheath removal']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulation Agents'}, {'cui': 'C0642228', 'cui_str': 'NOAC'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}]","[{'cui': 'C0015809', 'cui_str': 'Femoral vein structure'}, {'cui': 'C0740166', 'cui_str': 'Haemostasis'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0740166', 'cui_str': 'Haemostasis'}, {'cui': 'C0009653', 'cui_str': 'Condoms'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}]",70.0,0.0663612,"CONCLUSIONS


Hemostasis obtained with a F8 suture after cryoballoon ablation for AF is associated with significantly less patient time in the electrophysiology laboratory, and an improved safety profile, compared to manual hemostasis, even amongst patients treated with a NOAC.","[{'ForeName': 'Vineet', 'Initials': 'V', 'LastName': 'Kumar', 'Affiliation': 'Department of Electrophysiology, INOVA Heart and Vascular Institute, INOVA Fairfax Hospital, Fairfax, Virginia.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Wish', 'Affiliation': 'Department of Electrophysiology, INOVA Heart and Vascular Institute, INOVA Fairfax Hospital, Fairfax, Virginia.'}, {'ForeName': 'Ganesh', 'Initials': 'G', 'LastName': 'Venkataraman', 'Affiliation': 'Department of Electrophysiology, Colorado Heart & Vascular, Lakewood, Colorado.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Bliden', 'Affiliation': 'Department of Electrophysiology, INOVA Heart and Vascular Institute, INOVA Fairfax Hospital, Fairfax, Virginia.'}, {'ForeName': 'Manila', 'Initials': 'M', 'LastName': 'Jindal', 'Affiliation': 'Department of Electrophysiology, INOVA Heart and Vascular Institute, INOVA Fairfax Hospital, Fairfax, Virginia.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Strickberger', 'Affiliation': 'Department of Electrophysiology, INOVA Heart and Vascular Institute, INOVA Fairfax Hospital, Fairfax, Virginia.'}]",Journal of cardiovascular electrophysiology,['10.1111/jce.14252']
796,31662409,"Improving Mood with Physical ACTivity (IMPACT) trial: a cluster randomised controlled trial to determine the effectiveness of a brief physical activity behaviour change intervention on depressive symptoms in young people, compared with psychoeducation, in addition to routine clinical care within youth mental health services-a protocol study.","INTRODUCTION


Depression is highly prevalent and the leading contributor to the burden of disease in young people worldwide, making it an ongoing priority for early intervention. As the current evidence-based interventions of medication and psychological therapy are only modestly effective, there is an urgent need for additional treatment strategies. This paper describes the rationale of the Improving Mood with Physical ACTivity (IMPACT) trial. The primary aim of the IMPACT trial is to determine the effectiveness of a physical activity intervention compared with psychoeducation, in addition to routine clinical care, on depressive symptoms in young people. Additional aims are to evaluate the intervention effects on anxiety and functional outcomes and examine whether changes in physical activity mediate improvements in depressive symptoms.
METHODS AND ANALYSIS


The study is being conducted in six youth mental health services across Australia and is using a parallel-group, two-arm, cluster randomised controlled trial design, with randomisation occurring at the clinician level. Participants aged between 12 years and 25 years with moderate to severe levels of depression are randomised to receive, in addition to routine clinical care, either: (1) a physical activity behaviour change intervention or (2) psychoeducation about physical activity. The primary outcome will be change in the Quick Inventory of Depressive Symptomatology, with assessments occurring at baseline, postintervention (end-point) and 6-month follow-up from end-point. Secondary outcome measures will address additional clinical outcomes, functioning and quality of life. IMPACT is to be conducted between May 2014 and December 2019.
ETHICS AND DISSEMINATION


Ethical approval was obtained from the University of Melbourne Human Research Ethics Committee on 8 June 2014 (HREC 1442228). Trial findings will be published in peer-reviewed journals and presented at conferences. Key messages will also be disseminated by the youth mental health services organisation (headspace National Youth Mental Health Foundation).
TRIAL REGISTRATION NUMBER


ACTRN12614000772640.",2019,Ethical approval was obtained from the University of Melbourne Human Research Ethics Committee on 8 June 2014 (HREC 1442228).,"['six youth mental health services across Australia', 'Participants aged between 12 years and 25 years with moderate to severe levels of depression', 'young people']","['physical activity intervention', 'physical activity behaviour change intervention or (2) psychoeducation about physical activity', 'physical activity behaviour change intervention']","['depressive symptoms', 'Quick Inventory of Depressive Symptomatology, with assessments occurring at baseline, postintervention (end-point) and 6-month follow-up from end-point', 'address additional clinical outcomes, functioning and quality of life']","[{'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0025355', 'cui_str': 'Mental Hygiene Services'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C1319226', 'cui_str': 'Level of depression'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0871175', 'cui_str': 'Psycho-education'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C4720917', 'cui_str': 'Quick inventory of depressive symptomatology (assessment scale)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0376649', 'cui_str': 'Address'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0034380'}]",,0.240432,Ethical approval was obtained from the University of Melbourne Human Research Ethics Committee on 8 June 2014 (HREC 1442228).,"[{'ForeName': 'Alexandra G', 'Initials': 'AG', 'LastName': 'Parker', 'Affiliation': 'Institute for Health and Sport, Victoria University, Footscray, Victoria, Australia alexandra.parker@vu.edu.au.'}, {'ForeName': 'Connie', 'Initials': 'C', 'LastName': 'Markulev', 'Affiliation': 'Centre for Youth Mental Health, The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Debra J', 'Initials': 'DJ', 'LastName': 'Rickwood', 'Affiliation': 'Department of Psychology, University of Canberra, Canberra, Australian Capital Territory, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Mackinnon', 'Affiliation': 'School of Population and Global Health, The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Rosemary', 'Initials': 'R', 'LastName': 'Purcell', 'Affiliation': 'Centre for Youth Mental Health, The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Alvarez-Jimenez', 'Affiliation': 'Centre for Youth Mental Health, The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Alison R', 'Initials': 'AR', 'LastName': 'Yung', 'Affiliation': 'Orygen, The National Centre of Excellence in Youth Mental Health, Parkville, Victoria, Australia.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'McGorry', 'Affiliation': 'Centre for Youth Mental Health, The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Hetrick', 'Affiliation': 'Orygen, The National Centre of Excellence in Youth Mental Health, Parkville, Victoria, Australia.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Jorm', 'Affiliation': 'School of Population and Global Health, The University of Melbourne, Melbourne, Victoria, Australia.'}]",BMJ open,['10.1136/bmjopen-2019-034002']
797,31649280,Effects of intramuscular and vaginal progesterone supplementation on frozen-thawed embryo transfer.,"This study was to investigate effects of progesterone vaginal sustained-release gel and intramuscular injection of progesterone on frozen-thawed embryos transfer in 3013 patients receiving vaginal progesterone sustained-release gel and progesterone injection in artificial cycle for frozen-thawed embryo transfer. All patients were divided into two groups: group A with progesterone intramuscular injection (60 mg/d) plus dydrogesterone (10 mg tid) and group B with progesterone vaginal sustained-release gel of progesterone (90 mg/d) plus dydrogesterone (10 mg tid). There were 1988 women in group A treated with progesterone injection and 1025 women in group B with progesterone vaginal sustained-release gel. There were no statistically (P > 0.05) significant difference between the two groups in age, years of infertility, body mass index, endometrial thickness at transfer time, the average numbers of embryo transferred, cause of infertility, number of cycles, pregnancy rate and ectopic pregnancy rate. No significant (P > 0.05) differences existed in the clinical pregnancy (52.5% vs. 56.0%) and ectopic pregnancy (2.2% vs. 3.0%) rate between groups A and B. However, group B with vaginal progesterone supplementation had significantly (P < 0.05) greater implantation (37.0% vs 34.4%), delivery (45.1% vs. 41.0%) and live birth (45.0% vs. 40.8%) rate than group A with intramuscular progesterone injection, whereas group A had significantly (P < 0.05) greater early abortion rate (19.4% vs. 15.3%) than group B. This study showed that vaginal gel progesterone supplementation has good effects on frozen-thawed embryo transfer and can significantly increase the rate of implantation, delivery and live birth but decrease the abortion rate compared with intramuscular progesterone injection.",2019,"There were no statistically (P > 0.05) significant difference between the two groups in age, years of infertility, body mass index, endometrial thickness at transfer time, the average numbers of embryo transferred, cause of infertility, number of cycles, pregnancy rate and ectopic pregnancy rate.","['1988 women in group A treated with', '3013 patients receiving vaginal progesterone sustained-release gel and progesterone injection in artificial cycle for frozen-thawed embryo transfer']","['dydrogesterone', 'progesterone vaginal sustained-release gel of progesterone (90\u2009mg/d) plus dydrogesterone', 'progesterone intramuscular injection', 'vaginal progesterone supplementation', 'progesterone vaginal sustained-release gel', 'progesterone injection', 'progesterone vaginal sustained-release gel and intramuscular injection of progesterone', 'intramuscular and vaginal progesterone supplementation']","['clinical pregnancy', 'implantation', 'frozen-thawed embryo transfer', 'infertility, body mass index, endometrial thickness at transfer time, the average numbers of embryo transferred, cause of infertility, number of cycles, pregnancy rate and ectopic pregnancy rate', 'live birth', 'early abortion rate', 'rate of implantation, delivery and live birth', 'abortion rate', 'ectopic pregnancy']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0373705', 'cui_str': 'Progesterone measurement (procedure)'}, {'cui': 'C0443318', 'cui_str': 'Sustained (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C2004457', 'cui_str': 'Artificial (qualifier value)'}, {'cui': 'C0013938', 'cui_str': 'Embryo Transfer'}]","[{'cui': 'C0013340', 'cui_str': 'Dydrogesterone'}, {'cui': 'C0373705', 'cui_str': 'Progesterone measurement (procedure)'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0443318', 'cui_str': 'Sustained (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0021492', 'cui_str': 'Intramuscular injection (procedure)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular (qualifier value)'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0013938', 'cui_str': 'Embryo Transfer'}, {'cui': 'C0021359', 'cui_str': 'Infertility'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0449951', 'cui_str': 'Number of embryos transferred (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0032987', 'cui_str': 'Ectopic Pregnancy'}, {'cui': 'C0481667', 'cui_str': 'Live Birth'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0000794', 'cui_str': 'Abortion Rate'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}]",3013.0,0.0200177,"There were no statistically (P > 0.05) significant difference between the two groups in age, years of infertility, body mass index, endometrial thickness at transfer time, the average numbers of embryo transferred, cause of infertility, number of cycles, pregnancy rate and ectopic pregnancy rate.","[{'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Jiang', 'Affiliation': 'The Second Hospital, Hebei Medical University, 215 West Heping Road, Shijiazhuang, 050000, Hebei Province, P.R. China.'}, {'ForeName': 'Zhuo-Ye', 'Initials': 'ZY', 'LastName': 'Luo', 'Affiliation': 'The Second Hospital, Hebei Medical University, 215 West Heping Road, Shijiazhuang, 050000, Hebei Province, P.R. China.'}, {'ForeName': 'Gui-Min', 'Initials': 'GM', 'LastName': 'Hao', 'Affiliation': 'The Second Hospital, Hebei Medical University, 215 West Heping Road, Shijiazhuang, 050000, Hebei Province, P.R. China. haoguimin@163.com.'}, {'ForeName': 'Bu-Lang', 'Initials': 'BL', 'LastName': 'Gao', 'Affiliation': 'The Second Hospital, Hebei Medical University, 215 West Heping Road, Shijiazhuang, 050000, Hebei Province, P.R. China.'}]",Scientific reports,['10.1038/s41598-019-51717-5']
798,31649304,Characterization and prediction of acute and sustained response to psychedelic psilocybin in a mindfulness group retreat.,"Meditation and psychedelics have played key roles in humankind's search for self-transcendence and personal change. However, neither their possible synergistic effects, nor related state and trait predictors have been experimentally studied. To elucidate these issues, we administered double-blind the model psychedelic drug psilocybin (315 μg/kg PO) or placebo to meditators (n = 39) during a 5-day mindfulness group retreat. Psilocybin increased meditation depth and incidence of positively experienced self-dissolution along the perception-hallucination continuum, without concomitant anxiety. Openness, optimism, and emotional reappraisal were predictors of the acute response. Compared with placebo, psilocybin enhanced post-intervention mindfulness and produced larger positive changes in psychosocial functioning at a 4-month follow-up, which were corroborated by external ratings, and associated with magnitude of acute self-dissolution experience. Meditation seems to enhance psilocybin's positive effects while counteracting possible dysphoric responses. These findings highlight the interactions between non-pharmacological and pharmacological factors, and the role of emotion/attention regulation in shaping the experiential quality of psychedelic states, as well as the experience of selflessness as a modulator of behavior and attitudes. A better comprehension of mechanisms underlying most beneficial psychedelic experiences may guide therapeutic interventions across numerous mental conditions in the form of psychedelic-assisted applications.",2019,"Compared with placebo, psilocybin enhanced post-intervention mindfulness and produced larger positive changes in psychosocial functioning at a 4-month follow-up, which were corroborated by external ratings, and associated with magnitude of acute self-dissolution experience.",[],"['placebo', 'Psilocybin', 'placebo, psilocybin', 'psychedelic psilocybin']","['Openness, optimism, and emotional reappraisal', 'psychosocial functioning', 'meditation depth and incidence of positively experienced self-dissolution']",[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0033850', 'cui_str': 'Psilocybin'}, {'cui': 'C0018533', 'cui_str': 'Psychedelic Agents'}]","[{'cui': 'C0547049', 'cui_str': 'Openness (qualifier value)'}, {'cui': 'C0237428', 'cui_str': 'Optimism'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0150277'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0036588', 'cui_str': 'Self'}]",,0.0515426,"Compared with placebo, psilocybin enhanced post-intervention mindfulness and produced larger positive changes in psychosocial functioning at a 4-month follow-up, which were corroborated by external ratings, and associated with magnitude of acute self-dissolution experience.","[{'ForeName': 'Lukasz', 'Initials': 'L', 'LastName': 'Smigielski', 'Affiliation': 'Neuropsychopharmacology and Brain Imaging, Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric University Hospital Zurich, University of Zurich, Lenggstrasse 31, CH-8032, Zurich, Switzerland. lu.smigielski@gmail.com.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kometer', 'Affiliation': 'Neuropsychopharmacology and Brain Imaging, Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric University Hospital Zurich, University of Zurich, Lenggstrasse 31, CH-8032, Zurich, Switzerland.'}, {'ForeName': 'Milan', 'Initials': 'M', 'LastName': 'Scheidegger', 'Affiliation': 'Neuropsychopharmacology and Brain Imaging, Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric University Hospital Zurich, University of Zurich, Lenggstrasse 31, CH-8032, Zurich, Switzerland.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Krähenmann', 'Affiliation': 'Neuropsychopharmacology and Brain Imaging, Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric University Hospital Zurich, University of Zurich, Lenggstrasse 31, CH-8032, Zurich, Switzerland.'}, {'ForeName': 'Theo', 'Initials': 'T', 'LastName': 'Huber', 'Affiliation': 'Neuropsychopharmacology and Brain Imaging, Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric University Hospital Zurich, University of Zurich, Lenggstrasse 31, CH-8032, Zurich, Switzerland.'}, {'ForeName': 'Franz X', 'Initials': 'FX', 'LastName': 'Vollenweider', 'Affiliation': 'Neuropsychopharmacology and Brain Imaging, Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric University Hospital Zurich, University of Zurich, Lenggstrasse 31, CH-8032, Zurich, Switzerland.'}]",Scientific reports,['10.1038/s41598-019-50612-3']
799,30031787,Additive effects of household food insecurity during pregnancy and infancy on maternal infant feeding styles and practices.,"Food insecurity, or the limited access to food, has been associated with maternal child feeding styles and practices. While studies in other parenting domains suggest differential and additive impacts of poverty-associated stressors during pregnancy and infancy, few studies have assessed relations between food insecurity during these sensitive times and maternal infant feeding styles and practices. This study sought to analyze these relations in low-income Hispanic mother-infant pairs enrolled in a randomized controlled trial of an early obesity prevention program (Starting Early). Food insecurity was measured prenatally and during infancy at 10 months. Food insecurity timing was categorized as never, prenatal only, infancy only, or both. Regression analyses were used to determine relations between food insecurity timing and styles and practices at 10 months, using never experiencing food insecurity as the reference, adjusting for family characteristics and material hardships. 412 mother-infant pairs completed 10-month assessments. Prolonged food insecurity during both periods was associated with greater pressuring, indulgent and laissez-faire styles compared to never experiencing food insecurity. Prenatal food insecurity was associated with less vegetable and more juice intake. If food insecurity is identified during pregnancy, interventions to prevent food insecurity from persisting into infancy may mitigate the development of obesity-promoting feeding styles and practices.",2018,"Prolonged food insecurity during both periods was associated with greater pressuring, indulgent and laissez-faire styles compared to never experiencing food insecurity.","['low-income Hispanic mother-infant pairs enrolled', '412 mother-infant pairs completed 10-month assessments']",['early obesity prevention program'],['Food insecurity'],"[{'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C3494174', 'cui_str': 'Food Insecurity'}]",412.0,0.0225395,"Prolonged food insecurity during both periods was associated with greater pressuring, indulgent and laissez-faire styles compared to never experiencing food insecurity.","[{'ForeName': 'Rachel S', 'Initials': 'RS', 'LastName': 'Gross', 'Affiliation': 'Department of Pediatrics, Division of General Pediatrics, New York University School of Medicine, Bellevue Hospital Center, 462 First Avenue, New York, NY, 10016, USA. Electronic address: Rachel.Gross@nyumc.org.'}, {'ForeName': 'Alan L', 'Initials': 'AL', 'LastName': 'Mendelsohn', 'Affiliation': 'Department of Pediatrics, Division of Developmental - Behavioral Pediatrics, New York University School of Medicine, Bellevue Hospital Center, 462 First Avenue, New York, NY, 10016, USA. Electronic address: alm5@nyu.edu.'}, {'ForeName': 'Mary Jo', 'Initials': 'MJ', 'LastName': 'Messito', 'Affiliation': 'Department of Pediatrics, Division of General Pediatrics, New York University School of Medicine, Bellevue Hospital Center, 462 First Avenue, New York, NY, 10016, USA. Electronic address: Mary.Messito@nyumc.org.'}]",Appetite,['10.1016/j.appet.2018.07.016']
800,30526074,Randomized control study of the effects of executive function training on peer difficulties of children with attention-deficit/hyperactivity disorder C subtype.,"Objective:  Attention-deficit/hyperactivity disorder C subtype (ADHD-C) is associated with social rejection and peer difficulties. The present study evaluates the comparative efficacy of group executive function training (GEFT) with social skills training (SST) in children with ADHD-C in China. Methods:  A randomized, controlled treatment outcome study that comprised of 52 boys and 29 girls (age range: 9-12   years old) was conducted. The primary variable (peer relationship), secondary variables (executive functions [EFs] and social skills) and ADHD symptoms (inattention and hyperactive) were measured before and after the intervention and 3-month follow-up. Results:  First, both GEFT and SST had instant effects on peer relationship. Second, GEFT mainly improved their EFs and self-control dimension of social skills. At the same time, ADHD symptoms were reduced. SST mainly improved their social skills, but had no effect on EFs and ADHD symptoms. Third, GEFT had better long-term effects than SST on peer relationship. Conclusion:  Executive function training produced more effective and lasting changes on peer difficulties of ADHD children.",2020,"SST mainly improved their social skills, but had no effect on EFs and ADHD symptoms.","['52 boys and 29 girls (age range: 9-12\u2009years old', 'children with ADHD-C in China', 'children with attention-deficit/hyperactivity disorder C subtype']","['SST', 'executive function training', 'Executive function training', 'group executive function training (GEFT) with social skills training (SST', 'GEFT and SST']","['EFs and self-control dimension of social skills', 'social skills', 'secondary variables (executive functions [EFs] and social skills) and ADHD symptoms (inattention and hyperactive', 'EFs and ADHD symptoms']","[{'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0449560', 'cui_str': 'Subtype (attribute)'}]","[{'cui': 'C0589092', 'cui_str': 'Executive functions training (regime/therapy)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0150777', 'cui_str': 'Social skills training (procedure)'}]","[{'cui': 'C0684274', 'cui_str': 'Self Regulation'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0679005', 'cui_str': 'Interpersonal Skills'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0424101', 'cui_str': 'Inattention (finding)'}, {'cui': 'C0424295', 'cui_str': 'Increased purposeful goal-directed activity'}]",52.0,0.0284158,"SST mainly improved their social skills, but had no effect on EFs and ADHD symptoms.","[{'ForeName': 'Yan-Ting', 'Initials': 'YT', 'LastName': 'Lan', 'Affiliation': 'School of Psychology, Beijing Normal University, Beijing, China.'}, {'ForeName': 'Xiang-Ping', 'Initials': 'XP', 'LastName': 'Liu', 'Affiliation': 'School of Psychology, Beijing Normal University, Beijing, China.'}, {'ForeName': 'Hong-Shan', 'Initials': 'HS', 'LastName': 'Fang', 'Affiliation': 'Department of Chinese Language and Literature, Beijing Normal University, Beijing, China.'}]",Applied neuropsychology. Child,['10.1080/21622965.2018.1509003']
801,30478716,"The effects of microdose LSD on time perception: a randomised, double-blind, placebo-controlled trial.","RATIONALE


Previous research demonstrating that lysergic acid diethylamide (LSD) produces alterations in time perception has implications for its impact on conscious states and a range of psychological functions that necessitate precise interval timing. However, interpretation of this research is hindered by methodological limitations and an inability to dissociate direct neurochemical effects on interval timing from indirect effects attributable to altered states of consciousness.
METHODS


We conducted a randomised, double-blind, placebo-controlled study contrasting oral administration of placebo with three microdoses of LSD (5, 10, and 20 μg) in older adults. Subjective drug effects were regularly recorded and interval timing was assessed using a temporal reproduction task spanning subsecond and suprasecond intervals.
RESULTS


LSD conditions were not associated with any robust changes in self-report indices of perception, mentation, or concentration. LSD reliably produced over-reproduction of temporal intervals of 2000 ms and longer with these effects most pronounced in the 10 μg dose condition. Hierarchical regression analyses indicated that LSD-mediated over-reproduction was independent of marginal differences in self-reported drug effects across conditions.
CONCLUSIONS


These results suggest that microdose LSD produces temporal dilation of suprasecond intervals in the absence of subjective alterations of consciousness.",2019,"RESULTS


LSD conditions were not associated with any robust changes in self-report indices of perception, mentation, or concentration.",['older adults'],"['lysergic acid diethylamide (LSD', 'microdose LSD', 'placebo']","['self-report indices of perception, mentation, or concentration', 'Subjective drug effects', 'time perception']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0024334', 'cui_str': 'LSD'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0728867', 'cui_str': 'Drug action (finding)'}, {'cui': 'C0040226', 'cui_str': 'Time Perception'}]",,0.381516,"RESULTS


LSD conditions were not associated with any robust changes in self-report indices of perception, mentation, or concentration.","[{'ForeName': 'Steliana', 'Initials': 'S', 'LastName': 'Yanakieva', 'Affiliation': 'Department of Psychology, Goldsmiths, University of London, 8 Lewisham Way, New Cross, London, SE14 6NW, UK.'}, {'ForeName': 'Naya', 'Initials': 'N', 'LastName': 'Polychroni', 'Affiliation': 'Department of Psychology, Goldsmiths, University of London, 8 Lewisham Way, New Cross, London, SE14 6NW, UK.'}, {'ForeName': 'Neiloufar', 'Initials': 'N', 'LastName': 'Family', 'Affiliation': 'Eleusis Pharmaceuticals Ltd, London, UK.'}, {'ForeName': 'Luke T J', 'Initials': 'LTJ', 'LastName': 'Williams', 'Affiliation': 'Eleusis Pharmaceuticals Ltd, London, UK.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Luke', 'Affiliation': 'Department of Psychology, Social Work, & Counselling, University of Greenwich, London, UK.'}, {'ForeName': 'Devin B', 'Initials': 'DB', 'LastName': 'Terhune', 'Affiliation': 'Department of Psychology, Goldsmiths, University of London, 8 Lewisham Way, New Cross, London, SE14 6NW, UK. d.terhune@gold.ac.uk.'}]",Psychopharmacology,['10.1007/s00213-018-5119-x']
802,32408692,The Wildman Programme. A Nature-Based Rehabilitation Programme Enhancing Quality of Life for Men on Long-Term Sick Leave: Study Protocol for a Matched Controlled Study In Denmark.,"Many men have poor mental health and need help to recover. However, designing a rehabilitation intervention that appeals to men is challenging. This study protocol aims to describe the 'Wildman Programme', which will be a nature-based rehabilitation programme for men on long-term sick leave due to health problems such as stress, anxiety, depression, post-cancer and chronic cancer, chronic obstructive pulmonary disease (COPD), cardiovascular disease, or diabetes type II. The programme will be a nature-based rehabilitation initiative combining nature experiences, attention training, body awareness training, and supporting community spirit. The aim of the study will be to examine whether the 'Wildman Programme' can help to increase quality of life and reduce stress among men with health problems compared to treatment as usual. The study will be a matched control study where an intervention group (number of respondents,  N  = 52) participating in a 12-week nature-based intervention will be compared to a control group ( N  = 52) receiving treatment as usual. Outcomes are measured at baseline (T1), post-treatment (T2), and at follow up 6 months post-intervention (T3). The results of this study will be important to state whether the method in the 'Wildman Programme' can be implemented as a rehabilitation offer in the Danish Healthcare System to help men with different health problems.",2020,The aim of the study will be to examine whether the 'Wildman Programme' can help to increase quality of life and reduce stress among men with health problems compared to treatment as usual.,['men with health problems'],['control group ( N  = 52) receiving treatment as usual'],"['quality of life and reduce stress', 'Quality of Life']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0033213', 'cui_str': 'Problem'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]",52.0,0.0257458,The aim of the study will be to examine whether the 'Wildman Programme' can help to increase quality of life and reduce stress among men with health problems compared to treatment as usual.,"[{'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Høegmark', 'Affiliation': 'Department of Psychology, University of Southern Denmark, 5230 Odense M, Denmark.'}, {'ForeName': 'Tonny Elmose', 'Initials': 'TE', 'LastName': 'Andersen', 'Affiliation': 'Department of Psychology, University of Southern Denmark, 5230 Odense M, Denmark.'}, {'ForeName': 'Patrik', 'Initials': 'P', 'LastName': 'Grahn', 'Affiliation': 'Department of Work Science, Business Economics and Environmental Psychology, Swedish University of Agricultural Sciences, SE-230 53 Alnarp, Sweden.'}, {'ForeName': 'Kirsten Kaya', 'Initials': 'KK', 'LastName': 'Roessler', 'Affiliation': 'Department of Psychology, University of Southern Denmark, 5230 Odense M, Denmark.'}]",International journal of environmental research and public health,['10.3390/ijerph17103368']
803,31669451,Enhanced exposure therapy for combat-related Posttraumatic Stress Disorder (PTSD): Study protocol for a randomized controlled trial.,"BACKGROUND


PTSD, which has been identified in up to 23% of post-9-11 veterans, often results in a chronic, pernicious course. Thus, effective treatments are imperative. The Institute of Medicine (IOM) concluded that the only intervention for PTSD with sufficient evidence to conclude efficacy is exposure therapy. This Phase III trial compares the efficacy of exposure therapy for combat-related PTSD delivered in two different formats- via virtual reality exposure therapy (VRE) or prolonged exposure therapy (PE)- combined with D-Cycloserine (DCS), a cognitive enhancer shown to facilitate the extinction of fear.
METHODS/DESIGN


Military personnel of any duty status and civilians deployed to Iraq and Afghanistan were eligible. Participants were randomly assigned to 9 sessions of exposure therapy (VRE or PE) and medication (50 mg DCS or placebo). Participants were treated at three geographically diverse sites. Participants were re-assessed at 3-months post-treatment. The co-primary hypotheses are that (1) DCS will augment response to exposure therapy (both VRE and PE) on PTSD symptoms; (2) VRE will be associated with greater improvement than PE. Genetic and psychophysiological markers will be evaluated as potential moderators and mediators of treatment outcomes as well as secondary outcomes.
DISCUSSION


This study is the first to compare the relative efficacy of DCS-augmented VRE versus PE on PTSD symptoms. The design has several advantages: participants received an active, effective treatment and predictors of response to treatment included genetic and psychobiological measures. The results may directly influence the future delivery of services, and contribute to the development of a standardized treatment protocol.
TRIAL REGISTRATION


NCT01352637.",2019,"This Phase III trial compares the efficacy of exposure therapy for combat-related PTSD delivered in two different formats- via virtual reality exposure therapy (VRE) or prolonged exposure therapy (PE)- combined with D-Cycloserine (DCS), a cognitive enhancer shown to facilitate the extinction of fear.
","['combat-related Posttraumatic Stress Disorder (PTSD', 'Military personnel of any duty status and civilians deployed to Iraq and Afghanistan were eligible']","['virtual reality exposure therapy (VRE) or prolonged exposure therapy (PE)- combined with D-Cycloserine (DCS', 'DCS-augmented VRE versus PE', 'exposure therapy (PE or VRE) and medication (50\u202fmg DCS or placebo']",[],"[{'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0026126', 'cui_str': 'Armed Forces Personnel'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0022066', 'cui_str': 'Republic of Iraq'}, {'cui': 'C0001732', 'cui_str': 'Afghanistan'}]","[{'cui': 'C3494470', 'cui_str': 'Virtual Reality Immersion Therapy'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0010590', 'cui_str': 'Cycloserine'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C1265175', 'cui_str': 'Vancomycin-Resistant Enterococci'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.105617,"This Phase III trial compares the efficacy of exposure therapy for combat-related PTSD delivered in two different formats- via virtual reality exposure therapy (VRE) or prolonged exposure therapy (PE)- combined with D-Cycloserine (DCS), a cognitive enhancer shown to facilitate the extinction of fear.
","[{'ForeName': 'JoAnn', 'Initials': 'J', 'LastName': 'Difede', 'Affiliation': 'Department of Psychiatry, Weill Cornell Medical College, 525 East 68(th) Street, New York, NY 10065, United States. Electronic address: jdifede@med.cornell.edu.'}, {'ForeName': 'Barbara O', 'Initials': 'BO', 'LastName': 'Rothbaum', 'Affiliation': 'Emory University School of Medicine, 12 Executive Pard Drive, Atlanta, GA 30329, United States.'}, {'ForeName': 'Albert A', 'Initials': 'AA', 'LastName': 'Rizzo', 'Affiliation': 'University of Southern California Institute for Creative Technologies, 12015 East Waterfront Drive, Los Angeles, CA 90094, United States.'}, {'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Wyka', 'Affiliation': 'Department of Psychiatry, Weill Cornell Medical College, 525 East 68(th) Street, New York, NY 10065, United States.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Spielman', 'Affiliation': 'Department of Psychiatry, Weill Cornell Medical College, 525 East 68(th) Street, New York, NY 10065, United States.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Jovanovic', 'Affiliation': 'Emory University School of Medicine, 12 Executive Pard Drive, Atlanta, GA 30329, United States.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Reist', 'Affiliation': 'Department of Research, Long Beach VA Medical Center, 5901 East 7(th) Street, Long Beach, CA 90822, United States.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Roy', 'Affiliation': 'Department of Medicine and Center for Neuroscience and Regenerative Medicine, Uniformed Services University of the Health Sciences, 4301 Jones Bridge Road, Bethesda, MD 20814, United States.'}, {'ForeName': 'Seth D', 'Initials': 'SD', 'LastName': 'Norrholm', 'Affiliation': 'Emory University School of Medicine, 12 Executive Pard Drive, Atlanta, GA 30329, United States.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Glatt', 'Affiliation': 'Department of Psychiatry, Weill Cornell Medical College, 525 East 68(th) Street, New York, NY 10065, United States.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Lee', 'Affiliation': 'Department of Psychiatry, Weill Cornell Medical College, 525 East 68(th) Street, New York, NY 10065, United States.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105857']
804,30539266,"Randomized, double-blind, placebo-controlled, crossover study of the effects of repeated-dose caffeine on neurobehavioral performance during 48 h of total sleep deprivation.","RATIONALE


Caffeine is widely used as a countermeasure against neurobehavioral impairment during sleep deprivation. However, little is known about the pharmacodynamic profile of caffeine administered repeatedly during total sleep deprivation.
OBJECTIVES


To investigate the effects of repeated caffeine dosing on neurobehavioral performance during sleep deprivation, we conducted a laboratory-based, randomized, double-blind, placebo-controlled, crossover, multi-dose study of repeated caffeine administration during 48 h of sleep deprivation. Twelve healthy adults (mean age 27.4 years, six women) completed an 18-consecutive-day in-laboratory study consisting of three 48 h total sleep deprivation periods separated by 3-day recovery periods. During each sleep deprivation period, subjects were awakened at 07:00 and administered caffeine gum (0, 200, or 300 mg) at 6, 18, 30, and 42 h of wakefulness. The Psychomotor Vigilance Test and Karolinska Sleepiness Scale were administered every 2 h.
RESULTS


The 200 and 300 mg doses of caffeine mitigated neurobehavioral impairment across the sleep deprivation period, approaching two-fold performance improvements relative to placebo immediately after the nighttime gum administrations. No substantive differences were noted between the 200 mg and 300 mg caffeine doses, and adverse effects were minimal.
CONCLUSIONS


The neurobehavioral effects of repeated caffeine dosing during sleep deprivation were most evident during the circadian alertness trough (i.e., at night). The difference between the 200 mg and 300 mg doses, in terms of the mitigation of performance impairment, was small. Neither caffeine dose fully restored performance to well-rested levels. These findings inform the development of biomathematical models that more accurately account for the time of day and sleep pressure-dependent effects of caffeine on neurobehavioral performance during sleep loss.",2019,"No substantive differences were noted between the 200 mg and 300 mg caffeine doses, and adverse effects were minimal.
","['Twelve healthy adults (mean age 27.4\xa0years, six women) completed an 18-consecutive-day in-laboratory study consisting of three 48\xa0h total sleep deprivation periods separated by 3-day recovery periods', '48\xa0h of total sleep deprivation', '48\xa0h of sleep deprivation']","['repeated-dose caffeine', 'caffeine gum', 'placebo', 'caffeine']","['neurobehavioral performance', 'adverse effects', 'Psychomotor Vigilance Test and Karolinska Sleepiness Scale']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0037316', 'cui_str': 'Sleep Deprivation'}, {'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}]","[{'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C1378701', 'cui_str': 'Gum (basic dose form)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0222045'}]",12.0,0.218318,"No substantive differences were noted between the 200 mg and 300 mg caffeine doses, and adverse effects were minimal.
","[{'ForeName': 'Devon A', 'Initials': 'DA', 'LastName': 'Hansen', 'Affiliation': 'Sleep and Performance Research Center and Elson S. Floyd College of Medicine, Washington State University, Spokane, WA, USA. devon.hansen@wsu.edu.'}, {'ForeName': 'Sridhar', 'Initials': 'S', 'LastName': 'Ramakrishnan', 'Affiliation': 'Department of Defense Biotechnology High Performance Computing Software Applications Institute, Telemedicine and Advanced Technology Research, US Army Medical Research and Materiel Command, Fort Detrick, Frederick, MD, USA.'}, {'ForeName': 'Brieann C', 'Initials': 'BC', 'LastName': 'Satterfield', 'Affiliation': 'Sleep and Performance Research Center and Elson S. Floyd College of Medicine, Washington State University, Spokane, WA, USA.'}, {'ForeName': 'Nancy J', 'Initials': 'NJ', 'LastName': 'Wesensten', 'Affiliation': 'Air Traffic Organization, Federal Aviation Administration, Washington, DC, USA.'}, {'ForeName': 'Matthew E', 'Initials': 'ME', 'LastName': 'Layton', 'Affiliation': 'Sleep and Performance Research Center and Elson S. Floyd College of Medicine, Washington State University, Spokane, WA, USA.'}, {'ForeName': 'Jaques', 'Initials': 'J', 'LastName': 'Reifman', 'Affiliation': 'Department of Defense Biotechnology High Performance Computing Software Applications Institute, Telemedicine and Advanced Technology Research, US Army Medical Research and Materiel Command, Fort Detrick, Frederick, MD, USA.'}, {'ForeName': 'Hans P A', 'Initials': 'HPA', 'LastName': 'Van Dongen', 'Affiliation': 'Sleep and Performance Research Center and Elson S. Floyd College of Medicine, Washington State University, Spokane, WA, USA.'}]",Psychopharmacology,['10.1007/s00213-018-5140-0']
805,31479537,Effect of a multicomponent intervention on achievement and improvements in quality-of-care indices among people with Type 2 diabetes in South Asia: the CARRS trial.,"AIMS


To evaluate whether and what combinations of diabetes quality metrics were achieved in a multicentre trial in South Asia evaluating a multicomponent quality improvement intervention that included non-physician care coordinators to promote adherence and clinical decision-support software to enhance physician practices, in comparision with usual care.
METHODS


Using data from the Centre for Cardiometabolic Risk Reduction in South Asia (CARRS) trial, we evaluated the proportions of trial participants achieving specific and combinations of five diabetes care targets (HbA 1c  <53 mmol/mol [7%], blood pressure <130/80 mmHg, LDL cholesterol <2.6 mmol/L, non-smoking status, and aspirin use). Additionally, we examined the proportions of participants achieving the following risk factor improvements from baseline: ≥11-mmol/mol (1%) reduction in HbA 1c  , ≥10-mmHg reduction in systolic blood pressure, and/or ≥0.26-mmol/l reduction in LDL cholesterol.
RESULTS


Baseline characteristics were similar in the intervention and usual care arms. Overall, 12.3%, 29.4%, 36.5%, 19.5% and 2.2% of participants in the intervention group and 16.2%, 38.3%, 31.6%, 11.3% and 0.8% of participants in the usual care group achieved any one, two, three, four or five targets, respectively. We noted sizeable improvements in HbA 1c  , blood pressure and cholesterol, and found that participants in the intervention group were twice as likely to achieve improvements in all three indices at 12 months that were sustained over 28 months of the study [relative risk 2.1 (95% CI 1.5,2.8) and 1.8 (95% CI 1.5,2.3), respectively].
CONCLUSIONS


The intervention was associated with significantly higher achievement of and greater improvements in composite diabetes quality care goals. However, among these higher-risk participants, very small proportions achieved the complete group of targets, which suggests that achievement of multiple quality-of-care goals is challenging and that other methods may be needed in closing care gaps.",2020,"We noted sizeable improvements in HbA 1c  , blood pressure and cholesterol, and found that participants in the intervention group were twice as likely to achieve improvements in all three indices at 12 months that were sustained over 28 months of the study [relative risk 2.1 (95% CI 1.5,2.8) and 1.8 (95% CI 1.5,2.3), respectively].
","['trial participants achieving specific and combinations of five diabetes care targets (HbA 1c  <53 mmol/mol [7%], blood pressure <130/80 mmHg, LDL cholesterol <2.6 mmol/L, non-smoking status, and aspirin use', 'people with Type 2 diabetes in South Asia', 'Using data from the Centre for Cardiometabolic Risk Reduction in South Asia']",['multicomponent intervention'],"['HbA 1c  , blood pressure and cholesterol', 'risk factor improvements from baseline: ≥11-mmol/mol (1%) reduction in HbA 1c  , ≥10-mmHg reduction in systolic blood pressure, and/or ≥0.26-mmol/l reduction in LDL cholesterol', 'composite diabetes quality care goals', 'quality-of-care indices']","[{'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C4517633', 'cui_str': 'Two point six'}, {'cui': 'C1532563', 'cui_str': 'umol/mL'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}]",[],"[{'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C1532563', 'cui_str': 'umol/mL'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C2930505', 'cui_str': 'Goals of Care'}, {'cui': 'C0034379', 'cui_str': 'Quality of Care'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",53.0,0.0579011,"We noted sizeable improvements in HbA 1c  , blood pressure and cholesterol, and found that participants in the intervention group were twice as likely to achieve improvements in all three indices at 12 months that were sustained over 28 months of the study [relative risk 2.1 (95% CI 1.5,2.8) and 1.8 (95% CI 1.5,2.3), respectively].
","[{'ForeName': 'M K', 'Initials': 'MK', 'LastName': 'Shah', 'Affiliation': 'Department of Family and Preventive Medicine, Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Kondal', 'Affiliation': 'Centre of Excellence, Centre for Cardiometabolic Risk Reduction in South Asia, Public Health Foundation of India, Gurgaon, India.'}, {'ForeName': 'S A', 'Initials': 'SA', 'LastName': 'Patel', 'Affiliation': 'Rollins School of Public Health, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Singh', 'Affiliation': 'Centre of Excellence, Centre for Cardiometabolic Risk Reduction in South Asia, Public Health Foundation of India, Gurgaon, India.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Devarajan', 'Affiliation': 'Centre of Excellence, Centre for Cardiometabolic Risk Reduction in South Asia, Public Health Foundation of India, Gurgaon, India.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Shivashankar', 'Affiliation': 'Centre for Chronic Disease Control India, Public Health Foundation of India, Gurgaon, India.'}, {'ForeName': 'V S', 'Initials': 'VS', 'LastName': 'Ajay', 'Affiliation': 'Centre of Excellence, Centre for Cardiometabolic Risk Reduction in South Asia, Public Health Foundation of India, Gurgaon, India.'}, {'ForeName': 'V U', 'Initials': 'VU', 'LastName': 'Menon', 'Affiliation': 'Department of Endocrinology and Diabetes, Amrita Institute of Medical Sciences, Kerala, India.'}, {'ForeName': 'P K', 'Initials': 'PK', 'LastName': 'Varthakavi', 'Affiliation': 'Department of Endocrinology, TNM College and BYL Nair Charity Hospital, Mumbai, India.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Viswanathan', 'Affiliation': 'MV Hospital for Diabetes & Diabetes Research Centre, Chennai, India.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Dharmalingam', 'Affiliation': 'Bangalore Endocrinology and Diabetes Research Centre, Karnataka, India.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Bantwal', 'Affiliation': ""Department of Endocrinology, St John's Medical College and Hospital, Karnataka, India.""}, {'ForeName': 'R K', 'Initials': 'RK', 'LastName': 'Sahay', 'Affiliation': 'Department of Endocrinology, Osmania General Hospital, Hyderabad, India.'}, {'ForeName': 'M Q', 'Initials': 'MQ', 'LastName': 'Masood', 'Affiliation': 'Department of Medicine, Section of Endocrinology and Diabetes, Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Khadgawat', 'Affiliation': 'Department of Endocrinology and Metabolism, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Desai', 'Affiliation': 'Department of Medicine Endocrine Unit, Goa Medical College, Goa, India.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Prabhakaran', 'Affiliation': 'Department of Medicine Endocrine Unit, Goa Medical College, Goa, India.'}, {'ForeName': 'K M V', 'Initials': 'KMV', 'LastName': 'Narayan', 'Affiliation': 'Rollins School of Public Health, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Tandon', 'Affiliation': 'Department of Medicine, Section of Endocrinology and Diabetes, Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'M K', 'Initials': 'MK', 'LastName': 'Ali', 'Affiliation': 'Rollins School of Public Health, Emory University, Atlanta, GA, USA.'}]",Diabetic medicine : a journal of the British Diabetic Association,['10.1111/dme.14124']
806,31615801,H igh-flow oxygen for children's  a irway surgery: rando m i s ed controll e d  t rial protocol (HAMSTER).,"INTRODUCTION


Hypoxaemia during anaesthesia for tubeless upper airway surgery in children with abnormal airways is common due to the complexity of balancing adequate depth of anaesthesia with maintenance of spontaneous breathing and providing an uninterrupted field of view of the upper airway for the surgeon. High-flow nasal oxygenation (HIGH-FLOW) can prolong safe apnoea time and be used in children with abnormal airways but to date has not been compared with the alternative technique of low-flow nasal oxygenation (LOW-FLOW). The aim is to investigate if use of HIGH-FLOW can reduce the number of hypoxaemic events requiring rescue oxygenation compared with LOW-FLOW. METHODS AND ANALYSIS:  H igh-flow oxygen for children's  a irway surgery: rando m i s ed controll e d  t   r ial (HAMSTER) is a multicentre, unmasked, randomised controlled, parallel group, superiority trial comparing two oxygenation techniques during anaesthesia. Children (n=530) aged >37 weeks to 16 years presenting for elective tubeless upper airway surgery who fulfil inclusion but not exclusion criteria will be randomised prior to surgery to HIGH-FLOW or LOW-FLOW post induction of anaesthesia. Maintenance of anaesthesia with HIGH-FLOW requires Total IntraVenous Anaesthesia (TIVA) and with LOW-FLOW, either inhalational or TIVA at discretion of anaesthetist. The primary outcome is the incidence of hypoxaemic events requiring interruption of procedure for rescue oxygenation by positive pressure ventilation and the secondary outcome includes total hypoxaemia time, adverse cardiorespiratory events and unexpected paediatric intensive care admission admission. Hypoxaemia is defined as Sp0 2  <90%. Analysis will be conducted on an intention-to-treat basis.
ETHICS AND DISSEMINATION


Ethical approval has been obtained by Children's Health Queensland Human Research Ethics Committee (HREC/18/QRCH/130). The trial commenced recruitment in 2018. The primary manuscript will be submitted for publication in a peer-reviewed journal.
TRIAL REGISTRATION NUMBER


The HAMSTER is registered with the Australia and New Zealand Clinical TrialsRegistry: ACTRN12618000949280.",2019,High-flow nasal oxygenation (HIGH-FLOW) can prolong safe apnoea time and be used in children with abnormal airways but to date has not been compared with the alternative technique of low-flow nasal oxygenation (LOW-FLOW).,"[""children's  a irway surgery: rando m"", 'children with abnormal airways', 'Children (n=530) aged >37 weeks to 16 years presenting for elective tubeless upper airway surgery who fulfil inclusion but not exclusion criteria will be randomised prior to']","['High-flow nasal oxygenation (HIGH-FLOW', 'anaesthesia with HIGH-FLOW requires Total IntraVenous Anaesthesia (TIVA) and with LOW-FLOW, either inhalational or TIVA', 'surgery to HIGH-FLOW or LOW-FLOW post induction of anaesthesia', 'HIGH-FLOW', 'tubeless upper airway surgery']","['Hypoxaemia', 'incidence of hypoxaemic events requiring interruption of procedure for rescue oxygenation by positive pressure ventilation and the secondary outcome includes total hypoxaemia time, adverse cardiorespiratory events and unexpected paediatric intensive care admission admission']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0205161', 'cui_str': 'Abnormal (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0473965', 'cui_str': 'Total intravenous anesthesia (procedure)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C3854651', 'cui_str': 'TIVA'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0853212', 'cui_str': 'Induction of anesthesia'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}]","[{'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C3266857', 'cui_str': 'Positive-Pressure Ventilation'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1627360', 'cui_str': 'Pediatric intensive care'}]",,0.224387,High-flow nasal oxygenation (HIGH-FLOW) can prolong safe apnoea time and be used in children with abnormal airways but to date has not been compared with the alternative technique of low-flow nasal oxygenation (LOW-FLOW).,"[{'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Humphreys', 'Affiliation': 'Paediatric Critical Care Research Group, Child Health Research Centre, The University of Queensland, Brisbane, Queensland, Australia susan.humphreys@uq.edu.au.'}, {'ForeName': 'Britta Sylvia', 'Initials': 'BS', 'LastName': 'von Ungern-Sternberg', 'Affiliation': ""Anaesthesia, Perth Children's Hospital, Nedlands, Queensland, Australia.""}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Skowno', 'Affiliation': ""Department of Anaesthesia, Children's Hospital at Westmead, Westmead, New South Wales, Australia.""}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Williams', 'Affiliation': 'Paediatric Critical Care Research Group, Child Health Research Centre, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Taylor', 'Affiliation': 'Paediatric Critical Care Research Group, Child Health Research Centre, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Taverner', 'Affiliation': ""Department of Anaesthesia, Women's and Children's Hospital Adelaide, North Adelaide, South Australia, Australia.""}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Gibbons', 'Affiliation': 'Statistics, Mater Medical Research Institute, South Brisbane, Queensland, Australia.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Burgoyne', 'Affiliation': ""Department of Anaesthesia, Women's and Children's Hospital Adelaide, North Adelaide, South Australia, Australia.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Sommerfield', 'Affiliation': ""Anaesthesia, Perth Children's Hospital, Nedlands, Queensland, Australia.""}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Stephens', 'Affiliation': ""Department of Anaesthesia, Queensland Children's Hospital, South Brisbane, Queensland, Australia.""}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Hallett', 'Affiliation': ""Department of Anaesthesia, Royal Children's Hospital Melbourne, Parkville, Victoria, Australia.""}, {'ForeName': 'Shyan', 'Initials': 'S', 'LastName': 'Vijayasekaran', 'Affiliation': 'University of Western Australia, Crawley, Western Australia, Australia.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Slee', 'Affiliation': ""Department of Surgery; Ear, Nose and Throat, Queensland Children's Hospital, South Brisbane, Queensland, Australia.""}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Burns', 'Affiliation': ""Department of Surgery; Ear, Nose and Throat, Queensland Children's Hospital, South Brisbane, Queensland, Australia.""}, {'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Sowa', 'Affiliation': 'Health Economics, The University of Queensland, South Brisbane, Queensland, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Davidson', 'Affiliation': ""Department of Anaesthesia, Royal Children's Hospital Melbourne, Parkville, Victoria, Australia.""}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Schibler', 'Affiliation': 'Paediatric Critical Care Research Group, Child Health Research Centre, The University of Queensland, Brisbane, Queensland, Australia.'}]",BMJ open,['10.1136/bmjopen-2019-031873']
807,30535860,Perceived duration of auditory oddballs: test of a novel pitch-window hypothesis.,"Unexpected oddball stimuli embedded within a series of otherwise identical standard stimuli tend to be overestimated in duration. The present study tested a pitch-window explanation of the auditory oddball effect on perceived duration in two experiments. For both experiments, participants listened to isochronous sequences consisting of a series of 400 Hz fixed-duration standard tones with an embedded oddball tone that differed in pitch and judged whether the variable-duration oddball was shorter or longer than the standard. Participants were randomly assigned to either a wide or narrow pitch-window condition, in which an anchor oddball was presented with high likelihood at either a far pitch (850 Hz) or a near pitch (550 Hz), respectively. In both pitch-window conditions, probe oddballs were presented with low likelihood at pitches that were either within or outside the frequency range established by the standard and anchor tones. Identical 700 Hz probe oddballs were perceived to be shorter in duration in the wide pitch-window condition than in the narrow pitch-window condition (Experiments 1 and 2), even when matching the overall frequency range of oddballs across conditions (Experiment 2). Results support the proposed pitch-window hypothesis, but are inconsistent with both enhanced processing and predictive coding accounts of the oddball effect.",2020,"Hz probe oddballs were perceived to be shorter in duration in the wide pitch-window condition than in the narrow pitch-window condition (Experiments 1 and 2), even when matching the overall frequency range of oddballs across conditions (Experiment 2).",['Identical 700'],"['novel pitch-window hypothesis', 'wide or narrow pitch-window condition, in which an anchor oddball was presented with high likelihood at either a far pitch (850\xa0Hz) or a near pitch']",['Perceived duration of auditory oddballs'],"[{'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}, {'cui': 'C4517862', 'cui_str': '700 (qualifier value)'}]","[{'cui': 'C0175681', 'cui_str': 'Pitch (observable entity)'}, {'cui': 'C0557702', 'cui_str': 'Window (physical object)'}, {'cui': 'C3854333', 'cui_str': 'Narrowing'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C1293132', 'cui_str': 'Anchoring'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C3840657', 'cui_str': '850 (qualifier value)'}, {'cui': 'C0475806', 'cui_str': 'Nr - Near'}]","[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}]",,0.0515572,"Hz probe oddballs were perceived to be shorter in duration in the wide pitch-window condition than in the narrow pitch-window condition (Experiments 1 and 2), even when matching the overall frequency range of oddballs across conditions (Experiment 2).","[{'ForeName': 'Elisa Kim', 'Initials': 'EK', 'LastName': 'Fromboluti', 'Affiliation': 'Department of Psychology, Michigan State University, East Lansing, MI, 48824, USA.'}, {'ForeName': 'J Devin', 'Initials': 'JD', 'LastName': 'McAuley', 'Affiliation': 'Department of Psychology, Michigan State University, East Lansing, MI, 48824, USA. dmcauley@msu.edu.'}]",Psychological research,['10.1007/s00426-018-1124-2']
808,30288723,Hoop training: a pilot study assessing the effectiveness of a multisensory approach to treatment of body image disturbance in anorexia nervosa.,"PURPOSE


We tested in a pilot study a new intervention for body image disturbance in anorexia nervosa (AN). Unlike common treatment approaches our hoop training targeted not only cognitive-emotional and visual aspects of body image, but also tactile and body-scaled action components.
METHODS


We assessed cognitive, visual, tactile and body-scaled action aspects of body image disturbance before and after completion of hoop training. Twelve AN patients completed treatment as usual (TAU) for body image, 14 completed hoop training in addition to TAU.
RESULTS


Results show that patients who completed the 8-week individual hoop training in addition to TAU improved more on body image disturbance tasks from baseline to follow-up than patients who completed only TAU. Hoop training specifically seems to affect tactile body image and body-scaled action.
CONCLUSIONS


Taken together, a treatment approach in which the full spectrum of body image disturbances in AN is targeted has a unique added effect over treatment as usual.
LEVEL OF EVIDENCE


Level II, non-randomized controlled study.",2019,"We assessed cognitive, visual, tactile and body-scaled action aspects of body image disturbance before and after completion of hoop training.","['anorexia nervosa', 'anorexia nervosa (AN']",['multisensory approach'],"['body image disturbance tasks', 'tactile body image and body-scaled action', 'cognitive, visual, tactile and body-scaled action aspects of body image disturbance']","[{'cui': 'C0003125', 'cui_str': 'Anorexia Nervosas'}]","[{'cui': 'C1292724', 'cui_str': 'Procedure approach'}]","[{'cui': 'C0558116', 'cui_str': 'Altered body image (finding)'}, {'cui': 'C0439815', 'cui_str': 'Tactile (qualifier value)'}, {'cui': 'C0005891', 'cui_str': 'Body Image'}, {'cui': 'C0222045'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}]",,0.0371735,"We assessed cognitive, visual, tactile and body-scaled action aspects of body image disturbance before and after completion of hoop training.","[{'ForeName': 'Anouk', 'Initials': 'A', 'LastName': 'Keizer', 'Affiliation': 'Faculty of Social and Behavioural Sciences, Experimental Psychology, Utrecht University, Heidelberglaan 1, 3584 CS, Utrecht, The Netherlands. a.keizer@uu.nl.'}, {'ForeName': 'Manja M', 'Initials': 'MM', 'LastName': 'Engel', 'Affiliation': 'Faculty of Social and Behavioural Sciences, Experimental Psychology, Utrecht University, Heidelberglaan 1, 3584 CS, Utrecht, The Netherlands.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Bonekamp', 'Affiliation': 'Altrecht Center for Eating Disorders Rintveld, Altrecht Mental Health Institute, Wenshoek 4, 3705 WE, Zeist, The Netherlands.'}, {'ForeName': 'Annemarie', 'Initials': 'A', 'LastName': 'Van Elburg', 'Affiliation': 'Altrecht Center for Eating Disorders Rintveld, Altrecht Mental Health Institute, Wenshoek 4, 3705 WE, Zeist, The Netherlands.'}]",Eating and weight disorders : EWD,['10.1007/s40519-018-0585-z']
809,30117342,Ripple Effects of the Communities Preventing Childhood Obesity Project.,"This research examines the practice of community coaching within coalitions in the Communities Preventing Childhood Obesity project. A quasi-experimental design was used in seven Midwestern states. Each state selected two rural, low-income communities with functioning health coalitions. Coalitions were randomly assigned to be intervention or comparison communities. After 4 years of the coaching intervention, ripple effect mapping served as one method for examining the coalitions' work that may affect children's weight status. A research team from each state conducted ripple effect mapping with their two coalitions, resulting in 14 ripple maps. Community capitals framework and the social-ecological model were used for coding the items identified within the ripple maps. A quantitative scoring analysis determined if differences existed between the intervention and comparison coalitions in terms of the activities, programs, funding, and partnerships for social-ecological model score (e.g., individual, community, policy levels), community capitals score, and ripples score (e.g., number of branches formed within the maps). All scores were higher in intervention communities; however, the differences were not statistically significant ( p  > .05). Assessing community assets, such as availability of a community coach, is necessary in order to decide whether to deploy certain resources when designing health promotion strategies.",2020,"All scores were higher in intervention communities; however, the differences were not statistically significant ( p > .05).","['seven Midwestern states', 'Each state selected two rural, low-income communities with functioning health coalitions']",[],[],"[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",[],[],,0.0126383,"All scores were higher in intervention communities; however, the differences were not statistically significant ( p > .05).","[{'ForeName': 'Abby L', 'Initials': 'AL', 'LastName': 'Gold', 'Affiliation': 'North Dakota State University, Fargo, ND, USA.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Bennett', 'Affiliation': 'Clay County Public Health, Moorhead, MN, USA.'}, {'ForeName': 'Rick J', 'Initials': 'RJ', 'LastName': 'Jansen', 'Affiliation': 'North Dakota State University, Fargo, ND, USA.'}, {'ForeName': 'Amy R', 'Initials': 'AR', 'LastName': 'Mobley', 'Affiliation': 'University of Connecticut, Storrs, CT, USA.'}, {'ForeName': 'Sandra B', 'Initials': 'SB', 'LastName': 'Procter', 'Affiliation': 'K-State Research and Extension, Manhattan, KS, USA.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Smathers', 'Affiliation': 'Ohio State University Extension, Columbus, OH, USA.'}, {'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Contreras', 'Affiliation': 'Michigan State University Extension, East Lansing, MI, USA.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Peters', 'Affiliation': 'K-State Research and Extension, Manhattan, KS, USA.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Keim', 'Affiliation': 'University of Wisconsin-Extension, Cooperative Extension, Madison, WI, USA.'}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Oscarson', 'Affiliation': 'South Dakota State University, Brookings, SD, USA.'}]",Health promotion practice,['10.1177/1524839918788581']
810,30293128,Functional Behavior-Based Cognitive-Behavioral Therapy for Obsessive Compulsive Behavior in Children with Autism Spectrum Disorder: A Randomized Controlled Trial.,"Children with autism spectrum disorder (ASD) experience obsessions and compulsions similar to those specified in DSM-5 for obsessive compulsive disorder yet little controlled research exists on treating these behaviours. Thirty-seven children (7-13 years old) were randomly assigned to a 9-week functional behavior-based cognitive behavior therapy (Fb-CBT) or Treatment As Usual. Independent assessors administered measures pre- and post-treatment and at 6-months. Two primary outcome measures indicated statistically significant differences between groups, with large corrected effect sizes (Hedge's g = 1.00 and 1.15, respectively). This is the first known RCT to exclusively treat obsessive compulsive behaviors (OCBs) in children and youth with high functioning (IQ ≥ 70) ASD, and suggests that Fb-CBT treatment shows promise in decreasing these behaviors and improving quality of life. Trial Registration This trial was registered with ClinicalTrials.gov (ID: NCT03123146).",2020,"Two primary outcome measures indicated statistically significant differences between groups, with large corrected effect sizes (Hedge's g = 1.00 and 1.15, respectively).","['Children with Autism', 'Thirty-seven children (7-13\xa0years old', 'Spectrum Disorder', 'Children with autism spectrum disorder (ASD', 'children and youth with high functioning (IQ\u2009≥\u200970) ASD']","['9-week functional behavior-based cognitive behavior therapy (Fb-CBT) or Treatment As Usual', 'Functional Behavior-Based Cognitive-Behavioral Therapy']",['Obsessive Compulsive Behavior'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}, {'cui': 'C4319569', 'cui_str': '37 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0600104', 'cui_str': 'Compulsive Behavior'}]",37.0,0.127394,"Two primary outcome measures indicated statistically significant differences between groups, with large corrected effect sizes (Hedge's g = 1.00 and 1.15, respectively).","[{'ForeName': 'Tricia', 'Initials': 'T', 'LastName': 'Vause', 'Affiliation': 'Departments of Child and Youth Studies and Applied Disability Studies, Brock University, 1812 Sir Isaac Brock Way, St. Catharines, ON, L2S 3A1, Canada. tvause@brocku.ca.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Jaksic', 'Affiliation': 'Department of Applied Disability Studies, Brock University, St. Catharines, ON, Canada.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Neil', 'Affiliation': 'Department of Applied Disability Studies, Brock University, St. Catharines, ON, Canada.'}, {'ForeName': 'Jan C', 'Initials': 'JC', 'LastName': 'Frijters', 'Affiliation': 'Department of Child and Youth Studies, Brock University, St. Catharines, ON, Canada.'}, {'ForeName': 'Grazyna', 'Initials': 'G', 'LastName': 'Jackiewicz', 'Affiliation': 'Private Practice, Niagara Falls, ON, Canada.'}, {'ForeName': 'Maurice', 'Initials': 'M', 'LastName': 'Feldman', 'Affiliation': 'Departments of Child and Youth Studies and Applied Disability Studies, Brock University, 1812 Sir Isaac Brock Way, St. Catharines, ON, L2S 3A1, Canada.'}]",Journal of autism and developmental disorders,['10.1007/s10803-018-3772-x']
811,30287607,Prevention of postcontrast acute kidney injury after percutaneous transluminal angioplasty by inducing RenalGuard controlled furosemide forced diuresis with matched hydration: study protocol for a randomised controlled trial.,"INTRODUCTION


Percutaneous transluminal angioplasty (PTA) is often complicated due to postcontrast acute kidney injury (PC-AKI) in patients diagnosed with chronic kidney disease (CKD). Hydration therapy is the cornerstone in the prevention of PC-AKI. Furosemide forced diuresis with matched hydration using the RenalGuard system enables a steady balance between diuresis and hydration. A randomised controlled trial will be performed in order to investigate whether furosemide forced diuresis with matched hydration in combination with the RenalGuard system decreases incidence of PC-AKI in patients with CKD receiving a PTA of the lower extremities. Furthermore, we will investigate whether sampling of urine biomarkers 4 hours after intervention can detect PC-AKI in an earlier stage compared with the golden standard, serum creatinine 48-72 hours postintervention.
METHODS AND ANALYSIS


A single-centre randomised controlled trial will be conducted. Patients >18 years in need of a PTA of the lower extremities and diagnosed with CKD will be randomly assigned to receive either standard of care prehydration and posthydration or furosemide forced diuresis with matched hydration periprocedural using the RenalGuard system. Four hours postintervention, a urine sample will be collected of all participating patients. Serum creatinine will be sampled within 10 days prior to intervention as well as 1, 3 and 30 days postintervention. The primary endpoint is incidence of PC-AKI post-PTA. Secondary endpoint is the rise of urine biomarkers 4 hours postintervention.
ETHICS AND DISSEMINATION


Study protocol is approved by the research ethics committee and institutional review board (reference number 16 T-201 and NL59809.096.16). Study results will be disseminated by oral presentation at conferences and will be submitted to a peer-reviewed journal. It is anticipated that study results will offer a solution to contrast-induced nephropathy in patients with CKD receiving a PTA of the lower extremities.
TRIAL REGISTRATION NUMBER


NTR6236; Pre-results.
EUDRACT NUMBER


2016-005072-10.",2018,A randomised controlled trial will be performed in order to investigate whether furosemide forced diuresis with matched hydration in combination with the RenalGuard system decreases incidence of PC-AKI in patients with CKD receiving a PTA of the lower extremities.,"['patients with CKD receiving a PTA of the lower extremities', 'patients diagnosed with chronic kidney disease (CKD', 'postcontrast acute kidney injury after percutaneous transluminal angioplasty by inducing RenalGuard controlled furosemide forced diuresis with matched hydration', 'Patients >18 years in need of a PTA of the lower extremities and diagnosed with CKD']","['Hydration therapy', 'Percutaneous transluminal angioplasty (PTA', 'Furosemide', 'standard of care prehydration and posthydration or furosemide forced diuresis with matched hydration periprocedural using the RenalGuard system', 'furosemide']","['rise of urine biomarkers 4\u2009hours postintervention', 'Serum creatinine', 'incidence of PC-AKI post-PTA']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0015522', 'cui_str': 'Factor Eleven'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C2609414', 'cui_str': 'Acute Renal Injury'}, {'cui': 'C2936666', 'cui_str': 'Percutaneous Transluminal Angioplasty'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0016860', 'cui_str': 'Furosemide'}, {'cui': 'C0554808', 'cui_str': 'Forced diuresis (procedure)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1321013', 'cui_str': 'Hydration'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0027552', 'cui_str': 'Needs'}]","[{'cui': 'C1321013', 'cui_str': 'Hydration'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2936666', 'cui_str': 'Percutaneous Transluminal Angioplasty'}, {'cui': 'C0015522', 'cui_str': 'Factor Eleven'}, {'cui': 'C0016860', 'cui_str': 'Furosemide'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0554808', 'cui_str': 'Forced diuresis (procedure)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0042037'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1292426', 'cui_str': '4 hours (qualifier value)'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0015522', 'cui_str': 'Factor Eleven'}]",,0.156081,A randomised controlled trial will be performed in order to investigate whether furosemide forced diuresis with matched hydration in combination with the RenalGuard system decreases incidence of PC-AKI in patients with CKD receiving a PTA of the lower extremities.,"[{'ForeName': 'Lars J J', 'Initials': 'LJJ', 'LastName': 'Bolt', 'Affiliation': 'Department of Surgery, Zuyderland Medisch Centrum Heerlen, Heerlen, The Netherlands.'}, {'ForeName': 'Tim Anton', 'Initials': 'TA', 'LastName': 'Sigterman', 'Affiliation': 'Department of Surgery, VieCuri Medisch Centrum, Venlo, The Netherlands.'}, {'ForeName': 'Atilla G', 'Initials': 'AG', 'LastName': 'Krasznai', 'Affiliation': 'Department of Surgery, Zuyderland Medisch Centrum Heerlen, Heerlen, The Netherlands.'}, {'ForeName': 'Cees-Jan J M', 'Initials': 'CJM', 'LastName': 'Sikkink', 'Affiliation': 'Department of Surgery, Zuyderland Medisch Centrum Heerlen, Heerlen, The Netherlands.'}, {'ForeName': 'Geert-Willem H', 'Initials': 'GH', 'LastName': 'Schurink', 'Affiliation': 'Department of Surgery, Maastricht University Medical Centre, Maastricht, The Netherlands.'}, {'ForeName': 'Lee Hans', 'Initials': 'LH', 'LastName': 'Bouwman', 'Affiliation': 'Department of Surgery, Zuyderland Medisch Centrum Heerlen, Heerlen, The Netherlands.'}]",BMJ open,['10.1136/bmjopen-2018-021842']
812,30006887,Action plan interrupted: resolution of proactive interference while coordinating execution of multiple action plans during sleep deprivation.,"The ability to retain an action plan to execute another is necessary for most complex, goal-directed behavior. Research shows that executing an action plan to an interrupting event can be delayed when it partly overlaps (vs. does not overlap) with the retained action plan. This phenomenon is known as partial repetition costs (PRCs). PRCs reflect proactive interference, which may be resolved by inhibitory, executive control processes. We investigated whether these inhibitory processes are compromised due to one night of sleep deprivation. Participants were randomized to a sleep-deprived group or a well-rested control group. All participants performed an action planning task at baseline after a full night of sleep, and again either after a night of sleep deprivation (sleep-deprived group) or a full night of sleep (control group). In this task, two visual events occurred in a sequence. Participants retained an action plan to the first event in working memory while executing a speeded action to the second (interrupting) event; afterwards, they executed the action to the first event. The two action plans either partly overlapped (required the same hand) or did not (required different hands). Results showed slower responses to the interrupting event during sleep deprivation compared to baseline and the control group. However, the magnitude of the PRCs was no different during sleep deprivation compared to baseline and the control group. Thus, one night of sleep deprivation slowed global responses to the interruption, but inhibitory processes involved in reducing proactive interference while responding to an interrupting event were not compromised. These findings are consistent with other studies that show sleep deprivation degrades global task performance, but does not necessarily degrade performance on isolated, executive control components of cognition. The possibility that our findings involve local as opposed to central inhibition is also discussed.",2020,"However, the magnitude of the PRCs was no different during sleep deprivation compared to baseline and the control group.",[],"['action planning task at baseline after a full night of sleep, and again either after a night of sleep deprivation (sleep-deprived group) or a full night of sleep (control group', 'sleep-deprived group or a well-rested control group']",[],[],"[{'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0037316', 'cui_str': 'Sleep Deprivation'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],,0.0135948,"However, the magnitude of the PRCs was no different during sleep deprivation compared to baseline and the control group.","[{'ForeName': 'Lisa R', 'Initials': 'LR', 'LastName': 'Fournier', 'Affiliation': 'Department of Psychology, Washington State University, Pullman, WA, USA. lfournier@wsu.edu.'}, {'ForeName': 'Devon A', 'Initials': 'DA', 'LastName': 'Hansen', 'Affiliation': 'Sleep and Performance Research Center, Washington State University, Spokane, WA, USA.'}, {'ForeName': 'Alexandra M', 'Initials': 'AM', 'LastName': 'Stubblefield', 'Affiliation': 'Department of Psychology, Washington State University, Pullman, WA, USA.'}, {'ForeName': 'Hans P A', 'Initials': 'HPA', 'LastName': 'Van Dongen', 'Affiliation': 'Sleep and Performance Research Center, Washington State University, Spokane, WA, USA.'}]",Psychological research,['10.1007/s00426-018-1054-z']
813,30112914,Transtheoretical model for change in obese adolescents: MERC randomized clinical trial.,"The randomized controlled trial evaluated the effectiveness of an intervention based on the Transtheoretical Model of Change on anthropometric, metabolic and motivational outcomes in obese adolescents. A total of 135 male and female adolescents were randomized to two groups: intervention group ( n  = 65) and control group ( n  = 70). The adolescents were evaluated 1 week before the interventions began and at the end of 12 weeks. There was no statistically significant difference between groups in the outcome variables. Intervention group reported magnitude of effect more expressive on body mass index percentile, waist circumference, waist-to-hip ratio, readiness to change diet and readiness to start exercise.",2020,"Intervention group reported magnitude of effect more expressive on body mass index percentile, waist circumference, waist-to-hip ratio, readiness to change diet and readiness to start exercise.","['obese adolescents', '135 male and female adolescents']",['intervention group ( n\u2009=\u200965) and control group'],"['anthropometric, metabolic and motivational outcomes', 'magnitude of effect more expressive on body mass index percentile, waist circumference, waist-to-hip ratio, readiness to change diet and readiness to start exercise']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1704240', 'cui_str': 'Magnitudes (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0205682', 'cui_str': 'Waist-Hip Ratio'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",135.0,0.0926711,"Intervention group reported magnitude of effect more expressive on body mass index percentile, waist circumference, waist-to-hip ratio, readiness to change diet and readiness to start exercise.","[{'ForeName': 'Raquel de Melo', 'Initials': 'RM', 'LastName': 'Boff', 'Affiliation': 'Pontificia Universidade Católica do Rio Grande do Sul (PUCRS), Brazil.'}, {'ForeName': 'Marina Alves', 'Initials': 'MA', 'LastName': 'Dornelles', 'Affiliation': 'Pontificia Universidade Católica do Rio Grande do Sul (PUCRS), Brazil.'}, {'ForeName': 'Ana Maria Pandolfo', 'Initials': 'AMP', 'LastName': 'Feoli', 'Affiliation': 'Pontificia Universidade Católica do Rio Grande do Sul (PUCRS), Brazil.'}, {'ForeName': 'Andreia da Silva', 'Initials': 'ADS', 'LastName': 'Gustavo', 'Affiliation': 'Pontificia Universidade Católica do Rio Grande do Sul (PUCRS), Brazil.'}, {'ForeName': 'Margareth da Silva', 'Initials': 'MDS', 'LastName': 'Oliveira', 'Affiliation': 'Pontificia Universidade Católica do Rio Grande do Sul (PUCRS), Brazil.'}]",Journal of health psychology,['10.1177/1359105318793189']
814,31641199,Calibrated interdental brushing for the prevention of periodontal pathogens infection in young adults - a randomized controlled clinical trial.,"Periodontal disease is clearly correlated with systemic disease. The presence of periodontal pathogens in interdental spaces in young, healthy adults is a strong indicator of the need to introduce daily interdental prophylaxis. Twenty-five subjects (aged 18-35 years), diagnosticated clinically as periodontally healthy, were enrolled in this study. One hundred interdental sites were included. Among these sites, 50 ""test"" sites were cleaned daily with calibrated interdental brushes (IDBs), whereas the other 50 sites were not cleaned and considered ""controls"". The interdental biofilm at these interdental sites was collected at the beginning of the study (basal) and at 1 week, 2 weeks, 3 weeks, 4 weeks, and 3 months. Real-time polymerase chain reaction (PCR) methodology was used to quantify (i) 19 periodontal bacteria, including Porphyromonas gingivalis, Treponema denticola, and Tannerella forsythia, and (ii) total bacteria. In the test sites, the quantity of total bacteria decreased over time with the use of IDBs. The bacteria from the red and orange Socransky complexes, which are associated with periodontal disease, significantly decreased in the test sites but not in the control sites. Bacteria from the yellow, and purple Socransky complexes, which are associated with periodontal health, increased significantly in both groups whereas bacteria from the blue Socransky complex increased significantly only in the test sites. Furthermore, at basal, 66% of test sites and 68% of control sites bled during interdental brushing. These percentages decreased by 85% in 3 months for the test sites and by 27% in the control sites. In conclusion, the daily use of calibrated IDBs can reduce periodontal pathogens, reestablish symbiotic microbiota and, decrease interdental inflammation in interdental sites of healthy young adults.",2019,These percentages decreased by 85% in 3 months for the test sites and by 27% in the control sites.,"['One hundred interdental sites were included', 'young adults', 'young, healthy adults', 'healthy young adults', 'Twenty-five subjects (aged 18-35 years), diagnosticated clinically as periodontally healthy']","['calibrated IDBs', 'Calibrated interdental brushing', 'Real-time polymerase chain reaction (PCR) methodology']","['interdental inflammation', 'quantity of total bacteria', 'Porphyromonas gingivalis, Treponema denticola, and Tannerella forsythia, and (ii) total bacteria']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0442104', 'cui_str': 'Interdental (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0442104', 'cui_str': 'Interdental (qualifier value)'}, {'cui': 'C1709846', 'cui_str': 'Real-Time PCR'}, {'cui': 'C0969625', 'cui_str': 'methodology'}]","[{'cui': 'C0442104', 'cui_str': 'Interdental (qualifier value)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C1265611', 'cui_str': 'Quantity finding'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1510439', 'cui_str': 'bacteria'}, {'cui': 'C0206347', 'cui_str': 'Porphyromonas'}, {'cui': 'C0318222', 'cui_str': 'Treponema denticola'}, {'cui': 'C0314961', 'cui_str': 'Bacteroides forsythus'}]",25.0,0.0172873,These percentages decreased by 85% in 3 months for the test sites and by 27% in the control sites.,"[{'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Bourgeois', 'Affiliation': 'Systemic Healthcare Laboratory EA4129, Faculty of Medicine Laennec, University Lyon 1, University of Lyon, Lyon, France.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Bravo', 'Affiliation': 'Department of Preventive and Community Dentistry, Faculty of Oral Medicine, University of Granada, Granada, Spain.'}, {'ForeName': 'Juan-Carlos', 'Initials': 'JC', 'LastName': 'Llodra', 'Affiliation': 'Department of Preventive and Community Dentistry, Faculty of Oral Medicine, University of Granada, Granada, Spain.'}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Inquimbert', 'Affiliation': 'Systemic Healthcare Laboratory EA4129, Faculty of Medicine Laennec, University Lyon 1, University of Lyon, Lyon, France.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Viennot', 'Affiliation': 'Systemic Healthcare Laboratory EA4129, Faculty of Medicine Laennec, University Lyon 1, University of Lyon, Lyon, France.'}, {'ForeName': 'Claude', 'Initials': 'C', 'LastName': 'Dussart', 'Affiliation': 'Systemic Healthcare Laboratory EA4129, Faculty of Medicine Laennec, University Lyon 1, University of Lyon, Lyon, France.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Carrouel', 'Affiliation': 'Systemic Healthcare Laboratory EA4129, Faculty of Medicine Laennec, University Lyon 1, University of Lyon, Lyon, France. florence.carrouel@univ-lyon1.fr.'}]",Scientific reports,['10.1038/s41598-019-51938-8']
815,30079791,Ultrasound-guided versus blind corticosteroid injections for De Quervain tendinopathy: a prospective randomized trial.,"A total of 154 patients with De Quervain tendinopathy were randomized into a blind injection group or an ultrasound-guided injection group to compare effectiveness and complications of steroid injection. The visual analogue scale score for pain, Finkelstein test result, and Disability of the Arm, Shoulder, and Hand (DASH) score were assessed at 12 and 24 weeks follow-up. At 12 weeks, the DASH scores were significantly better in the ultrasound-guided group, but the mean difference was less than the minimum clinically important difference. There was no difference in the DASH scores between the groups at 24 weeks. The pain scores were not significantly different between the two groups at 12 and 24 weeks. The incidence of treatment failure did not significantly differ between two groups. Incidences of soft tissue atrophy or skin depigmentation were significantly greater in patients with blind injection than with ultrasound-guided injection. We conclude that ultrasound-guided steroid injection for De Quervain tendinopathy reduces steroid-associated complications but has similar pain relieving and functional outcomes as blind injection.
LEVEL OF EVIDENCE


I.",2018,Incidences of soft tissue atrophy or skin depigmentation were significantly greater in patients with blind injection than with ultrasound-guided injection.,"['De Quervain tendinopathy', '154 patients with De Quervain tendinopathy']","['Ultrasound-guided versus blind corticosteroid injections', 'ultrasound-guided injection', 'steroid injection']","['DASH scores', 'pain scores', 'Incidences of soft tissue atrophy or skin depigmentation', 'incidence of treatment failure', 'visual analogue scale score for pain, Finkelstein test result, and Disability of the Arm, Shoulder, and Hand (DASH) score']","[{'cui': 'C1568272', 'cui_str': 'Tendinopathy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C2363868', 'cui_str': 'Soft tissue atrophy'}, {'cui': 'C0262977', 'cui_str': 'Achromia of skin (disorder)'}, {'cui': 'C0162643'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231669', 'cui_str': 'Finkelsteins test response'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0018563', 'cui_str': 'Hand'}]",154.0,0.0673552,Incidences of soft tissue atrophy or skin depigmentation were significantly greater in patients with blind injection than with ultrasound-guided injection.,"[{'ForeName': 'Young Hak', 'Initials': 'YH', 'LastName': 'Roh', 'Affiliation': '1 Department of Orthopaedic Surgery, Ewha Womans University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Seok Woo', 'Initials': 'SW', 'LastName': 'Hong', 'Affiliation': '1 Department of Orthopaedic Surgery, Ewha Womans University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Hyun Sik', 'Initials': 'HS', 'LastName': 'Gong', 'Affiliation': '2 Department of Orthopaedic Surgery, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Goo Hyun', 'Initials': 'GH', 'LastName': 'Baek', 'Affiliation': '2 Department of Orthopaedic Surgery, Seoul National University College of Medicine, Seoul, Korea.'}]","The Journal of hand surgery, European volume",['10.1177/1753193418790535']
816,31630683,"Evaluation of the safety, tolerance and efficacy of 1-year consumption of infant formula supplemented with Lactobacillus fermentum CECT5716 Lc40 or Bifidobacterium breve CECT7263: a randomized controlled trial.","BACKGROUND


The microorganism present in breast milk, added to other factors, determine the colonization of infants. The objective of the present study is to evaluate the safety, tolerance and effects of the consumption of a milk formula during the first year of life that is supplemented with L. fermentum CECT5716 or Bifidobacterium breve CECT7263, two strains originally isolated from breast milk.
METHODS


A randomized, double blind, controlled, parallel group study including healthy, formula-fed infants was conducted. Two hundred and thirty-six 1-month-old infants were selected and randomly divided into three study groups according to a randomization list. Infants in the control group received a standard powdered infant formula until 12 months of age. Infants in the probiotic groups received the same infant formula but supplemented with L. fermentum CECT5716 Lc40 or B. breve CECT7263. Main outcome was weigh-gain of infants as safety marker.
RESULTS


One hundred and eighty-nine infants completed the eleven months of intervention (61 in control group, 65 in Lf group and 63 in Bb group). The growth of infants in the three groups was consistent with standards. No significant differences were observed in the main outcome, weight-gain (Control group: 5.77 Kg ± 0.95, Lf group: 5.77 Kg ± 1.31, Bb group: 5.58 Kg ± 1.10; p = 0.527). The three milk formulae were well tolerated, and no adverse effects were related to the consumption of any of the formula. Infants receiving B. breve CECT7263 had a 1.7 times lower risk of crying than the control group (OR = 0.569, CI 95% 0.568-0.571; p = 0.001). On the other hand, the incidence of diarrhoea in infants receiving the formula supplemented with L. fermentum CECT5716 was a 44% lower than in infants receiving the control formula (p = 0.014). The consumption of this Lactobacillus strain also reduced the duration of diarrhoea by 2.5 days versus control group (p = 0.044).
CONCLUSIONS


The addition of L. fermentum CECT5716 Lc40 or B. breve CECT7263, two probiotic strains naturally found in breast milk, to infant formulae is safe and induces beneficial effects on the health of infants.
TRIAL REGISTRATION


The trial was retrospectively registered in the US Library of Medicine ( www.clinicaltrial.gov ) with the number NCT03204630 . Registered 11 August 2016.",2019,"The consumption of this Lactobacillus strain also reduced the duration of diarrhoea by 2.5 days versus control group (p = 0.044).
","['Two hundred and thirty-six 1-month-old infants', 'healthy, formula-fed infants', 'One hundred and eighty-nine infants completed the eleven months of intervention (61 in control group, 65 in Lf group and 63 in Bb group']","['Lactobacillus fermentum CECT5716 Lc40 or Bifidobacterium breve CECT7263', 'same infant formula but supplemented with L. fermentum CECT5716 Lc40 or B. breve CECT7263']","['incidence of diarrhoea', 'weight-gain', 'risk of crying', 'duration of diarrhoea', 'weigh-gain of infants as safety marker']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4319606', 'cui_str': 'Thirty-six'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0317603', 'cui_str': 'Lactobacillus fermentum'}, {'cui': 'C0314975', 'cui_str': 'Bifidobacterium breve'}, {'cui': 'C0150589', 'cui_str': 'Baby Formula'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0010399', 'cui_str': 'Cryings'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",189.0,0.135768,"The consumption of this Lactobacillus strain also reduced the duration of diarrhoea by 2.5 days versus control group (p = 0.044).
","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Maldonado', 'Affiliation': 'Pediatric Unit, University Hospital Virgen de las Nieves, Granada, Spain.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Gil-Campos', 'Affiliation': 'Unit of Metabolism and Pediatric Research (IMIBIC), Reina Sofia University Hospital, University of Córdoba, Cordoba, Spain.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Maldonado-Lobón', 'Affiliation': 'Biosearch Life, Research Department, Granada, Spain.'}, {'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'Benavides', 'Affiliation': 'Pediatric Clinic Roquetas, Roquetas de Mar, Almería, Spain.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Flores-Rojas', 'Affiliation': 'Unit of Metabolism and Pediatric Research (IMIBIC), Reina Sofia University Hospital, University of Córdoba, Cordoba, Spain.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Jaldo', 'Affiliation': 'Andalusian Health Service, Andalusia, Spain.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Jiménez Del Barco', 'Affiliation': 'Clinic ""Cristo de la Salud"" Albolote, Granada, Spain.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Bolívar', 'Affiliation': 'Andalusian Health Service, Andalusia, Spain.'}, {'ForeName': 'A D', 'Initials': 'AD', 'LastName': 'Valero', 'Affiliation': 'Biosearch Life, Research Department, Granada, Spain.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Prados', 'Affiliation': 'Andalusian Health Service, Andalusia, Spain.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Peñalver', 'Affiliation': 'Andalusian Health Service, Andalusia, Spain.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Olivares', 'Affiliation': 'Biosearch Life, Research Department, Granada, Spain. molivares@biosearchlife.com.'}]",BMC pediatrics,['10.1186/s12887-019-1753-7']
817,29974808,Mindfulness-based cognitive therapy for obsessive-compulsive disorder: Study protocol for a randomized controlled trial with functional magnetic resonance imaging and a 6-month follow-up.,"This article presents a study protocol for a single-blind randomized controlled trial to test the efficacy and feasibility of mindfulness-based cognitive therapy. A total of 120 un-medicated Chinese obsessive-compulsive disorder patients will be randomized to the mindfulness-based cognitive therapy group, the selective serotonin reuptake inhibitor group or the psycho-education group for 11 sessions in 10 weeks. A range of scales for clinical symptoms and functional magnetic resonance imaging will be completed at baseline (week 0), mid-intervention (week 4), post-intervention (week 10) and the 6-month follow-up (weeks 14, 22 and 34). The study will have relevance to decisions about treatment options for un-medicated obsessive-compulsive disorder patients.",2020,"A total of 120 un-medicated Chinese obsessive-compulsive disorder patients will be randomized to the mindfulness-based cognitive therapy group, the selective serotonin reuptake inhibitor group or the psycho-education group for 11 sessions in 10 weeks.","['obsessive-compulsive disorder', 'un-medicated obsessive-compulsive disorder patients', '120 un-medicated Chinese obsessive-compulsive disorder patients']","['Mindfulness-based cognitive therapy', 'functional magnetic resonance imaging', 'mindfulness-based cognitive therapy group, the selective serotonin reuptake inhibitor group or the psycho-education', 'mindfulness-based cognitive therapy']",[],"[{'cui': 'C0028768', 'cui_str': 'Anankastic Personality'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}]","[{'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4552594', 'cui_str': 'SSRI - Selective serotonin reuptake inhibitor'}, {'cui': 'C0871175', 'cui_str': 'Psycho-education'}]",[],,0.0582276,"A total of 120 un-medicated Chinese obsessive-compulsive disorder patients will be randomized to the mindfulness-based cognitive therapy group, the selective serotonin reuptake inhibitor group or the psycho-education group for 11 sessions in 10 weeks.","[{'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Lu', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, P.R. China.'}, {'ForeName': 'Tianran', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, P.R. China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Gao', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, P.R. China.'}, {'ForeName': 'Zongfeng', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, P.R. China.'}, {'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'Cao', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, P.R. China.'}, {'ForeName': 'Yongjun', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, P.R. China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, P.R. China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, P.R. China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, P.R. China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, P.R. China.'}, {'ForeName': 'Yanle', 'Initials': 'Y', 'LastName': 'Bai', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, P.R. China.'}, {'ForeName': 'Jianyu', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, P.R. China.'}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'Didonna', 'Affiliation': 'Casa di Cura Villa Margherita, Italy.'}, {'ForeName': 'Haiyin', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, P.R. China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Fan', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, P.R. China.'}]",Journal of health psychology,['10.1177/1359105318780540']
818,31834062,"Online Family Problem-Solving Therapy (F-PST) for Executive and Behavioral Dysfunction After Traumatic Brain Injury in Adolescents: A Randomized, Multicenter, Comparative Effectiveness Clinical Trial.","OBJECTIVE


To examine the comparative effectiveness of 3 modes of family problem-solving therapy (F-PST): therapist-guided online, self-guided online, and face-to-face.
SETTING


Four children's hospitals and a general hospital with pediatric commitment.
PARTICIPANTS


A total of 150 adolescents aged 14 to 18 years, previously hospitalized with traumatic brain injury (TBI), and evidence of behavior problems at enrollment.
DESIGN


Multicenter, randomized clinical trial.
MAIN MEASURES


Behavior Rating Inventory of Executive Function (BRIEF) Global Executive Composite (GEC), Behavior Regulation Index, and Metacognition Index, and Strengths and Difficulties Questionnaire (SDQ) Total at baseline and 6 and 9 months later.
RESULTS


Mixed-model intention-to-treat analyses of comparative effectiveness failed to reveal statistically significant differences among treatment groups. At 6 months, parent BRIEF-GEC improved for the therapist-guided and self-guided, online groups. Effects remained significant and increased in magnitude at 9 months for the self-guided online group. Scores for the Self-guided online group significantly improved from baseline to 9 months on the SDQ Total.
CONCLUSIONS


This comparative effectiveness study supports the utility of both self- and therapist-guided online F-PST in improving executive function behaviors in adolescents following TBI. Further work regarding clinical implementation and how best to integrate telehealth with ongoing rehabilitation care is warranted.",2020,This comparative effectiveness study supports the utility of both self- and therapist-guided online F-PST in improving executive function behaviors in adolescents following TBI.,"['A total of 150 adolescents aged 14 to 18 years, previously hospitalized with traumatic brain injury (TBI), and evidence of behavior problems at enrollment', 'Adolescents', 'adolescents following TBI', ""Four children's hospitals and a general hospital with pediatric commitment""]","['self- and therapist-guided online F-PST', 'Online Family Problem-Solving Therapy (F-PST', 'family problem-solving therapy (F-PST): therapist-guided online, self-guided online, and face-to-face']","['Executive and Behavioral Dysfunction', 'Behavior Rating Inventory of Executive Function (BRIEF', 'executive function behaviors', 'Global Executive Composite (GEC), Behavior Regulation Index, and Metacognition Index, and Strengths and Difficulties Questionnaire (SDQ) Total', 'parent BRIEF-GEC']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0876926', 'cui_str': 'TBI (Traumatic Brain Injury)'}, {'cui': 'C0332120', 'cui_str': 'Evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0020017', 'cui_str': 'Hospitals, Pediatric'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0424960', 'cui_str': 'Family problems (finding)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}]","[{'cui': 'C0031847', 'cui_str': 'pathophysiology'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0589513', 'cui_str': 'Meta-cognition'}, {'cui': 'C3472494', 'cui_str': 'Strengths and difficulties questionnaire (assessment scale)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}]",150.0,0.091132,This comparative effectiveness study supports the utility of both self- and therapist-guided online F-PST in improving executive function behaviors in adolescents following TBI.,"[{'ForeName': 'Brad G', 'Initials': 'BG', 'LastName': 'Kurowski', 'Affiliation': ""Division of Pediatric Rehabilitation Medicine, Departments of Pediatrics and Neurology and Rehabilitation Medicine (Dr Kurowski), Division of Epidemiology and Biostatistics, Department of Pediatrics (Dr Cassedy), Division of Neurology, Department of Pediatrics (Dr Horn), and Division of Pediatric Rehabilitation Medicine, Department of Pediatrics (Dr Wade), Cincinnati Children's Hospital Medical Center, University of Cincinnati College of Medicine, Ohio; Biobehavioral Health Center, Abigail Wexner Research Institute at Nationwide Children's Hospital and The Ohio State University, Columbus, and Case Western Reserve University and Rainbow Babies & Children's Hospital, University Hospitals Cleveland Medical Center, Cleveland, Ohio (Dr Taylor); Nationwide Children's Hospital and The Ohio State University, Columbus, Ohio (Dr McNally); Children's Hospital Colorado and University of Colorado School of Medicine, Aurora, Colorado (Dr Kirkwood); and MetroHealth Medical Center and Case Western Reserve University, Cleveland, Ohio (Dr Stancin).""}, {'ForeName': 'H Gerry', 'Initials': 'HG', 'LastName': 'Taylor', 'Affiliation': ''}, {'ForeName': 'Kelly A', 'Initials': 'KA', 'LastName': 'McNally', 'Affiliation': ''}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Kirkwood', 'Affiliation': ''}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Cassedy', 'Affiliation': ''}, {'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'Horn', 'Affiliation': ''}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Stancin', 'Affiliation': ''}, {'ForeName': 'Shari L', 'Initials': 'SL', 'LastName': 'Wade', 'Affiliation': ''}]",The Journal of head trauma rehabilitation,['10.1097/HTR.0000000000000545']
819,31641754,"Efficacy and Safety of a Single Dose of Ivermectin, Diethylcarbamazine, and Albendazole for Treatment of Lymphatic Filariasis in Côte d'Ivoire: An Open-label Randomized Controlled Trial.","BACKGROUND


Improved drug regimens are needed to accelerate elimination of lymphatic filariasis in Africa. This study determined whether a single co-administered dose of ivermectin plus diethylcarbamazine plus albendazole [IDA] is noninferior to standard 3 annual doses of ivermectin plus albendazole (IA) used in many LF-endemic areas of Africa.
METHODS


Treatment-naive adults with Wuchereria bancrofti microfilaremia in Côte d'Ivoire were randomized to receive a single dose of IDA (n = 43) or 3 annual doses of IA (n = 52) in an open-label, single-blinded trial. The primary endpoint was the proportion of participants who were microfilaria (Mf) negative at 36 months. Secondary endpoints were Mf clearance at 6, 12, and 24 months; inactivation of adult worm nests; and safety.
RESULTS


At 36 months posttreatment with IDA, 18/33 (55%; 95% CI, 38-72%) cleared Mf versus 33/42 (79%; 67-91%) with IA (P = .045). At 6 and 12 months IDA was superior to IA in clearing Mf (89% [77-99%] and 71% [56-85%]), respectively, versus 34% (20-48%) and 26% (14-42%) (P < .001). IDA was equivalent to IA at 24 months (61% [45-77%] vs 54% [38-72%]; P = .53). IDA was superior to IA for inactivating adult worms at all time points. Both treatments were well tolerated, and there were no serious adverse events.
CONCLUSIONS


A single dose of IDA was superior to 2 doses of IA in reducing the overall Mf burden by 24 months. Reinfection may have contributed to the lack of sustained clearance of Mf with IDA.
CLINICAL TRIALS REGISTRATION


NCT02974049.",2020,"At 6 and 12 months IDA was superior to IA in clearing Mf (89%, CI 77-99, and 71%, CI 56-85) respectively versus 34% CI 20-48, and 26%, CI 14-42, P<0.001.","[""Treatment-naïve adults with Wuchereria bancrofti microfilaremia in Agboville district of Côte d'Ivoire"", ""lymphatic filariasis in Côte d'Ivoire""]","['IDA (N=43) or 3 annual doses of IA', 'ivermectin, diethylcarbamazine and albendazole', 'IDA', 'ivermectin plus albendazole (IA', 'ivermectin plus diethylcarbamazine plus albendazole, IDA']","['overall Mf burden', 'Mf clearance at 6, 12 and 24 months, inactivation of adult worm nests, and safety', 'Efficacy and safety', 'IDA', 'proportion of participants microfilaria (Mf)-negative', 'clearing Mf']","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043272', 'cui_str': 'Filaria bancrofti'}, {'cui': 'C0013884', 'cui_str': 'Bancroftian Elephantiasis'}]","[{'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0022322', 'cui_str': 'Ivermectin'}, {'cui': 'C0012191', 'cui_str': 'Diethylcarbamazine'}, {'cui': 'C0001911', 'cui_str': 'Albendazole'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0018889', 'cui_str': 'Helminthiasis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0025980', 'cui_str': 'Microfilaria'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}]",,0.246034,"At 6 and 12 months IDA was superior to IA in clearing Mf (89%, CI 77-99, and 71%, CI 56-85) respectively versus 34% CI 20-48, and 26%, CI 14-42, P<0.001.","[{'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Bjerum', 'Affiliation': 'Center for Global Health and Diseases, Case Western Reserve University School of Medicine, Cleveland, Ohio, USA.'}, {'ForeName': 'Allassane F', 'Initials': 'AF', 'LastName': 'Ouattara', 'Affiliation': ""Centre Suisse de Recherche Scientifique en Côte d'Ivoire, Abidjan, Côte d'Ivoire.""}, {'ForeName': 'Méité', 'Initials': 'M', 'LastName': 'Aboulaye', 'Affiliation': ""Programme National de la Lutte Contre la Schistosomiase, Les Geohelminthiases et la Filariose Lymphatique, Abidjan, Côte d'Ivoire.""}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Kouadio', 'Affiliation': ""Centre Suisse de Recherche Scientifique en Côte d'Ivoire, Abidjan, Côte d'Ivoire.""}, {'ForeName': 'Vanga K', 'Initials': 'VK', 'LastName': 'Marius', 'Affiliation': ""Universite Alassane Ouattara Centre Hospitalier Universitaire de Bouake, Bouaké, Côte d'Ivoire.""}, {'ForeName': 'Britt J', 'Initials': 'BJ', 'LastName': 'Andersen', 'Affiliation': 'Infectious Diseases Division, Department of Medicine, Washington University School of Medicine, St Louis, Missouri, USA.'}, {'ForeName': 'Gary J', 'Initials': 'GJ', 'LastName': 'Weil', 'Affiliation': 'Infectious Diseases Division, Department of Medicine, Washington University School of Medicine, St Louis, Missouri, USA.'}, {'ForeName': 'Benjamin G', 'Initials': 'BG', 'LastName': 'Koudou', 'Affiliation': ""Centre Suisse de Recherche Scientifique en Côte d'Ivoire, Abidjan, Côte d'Ivoire.""}, {'ForeName': 'Christopher L', 'Initials': 'CL', 'LastName': 'King', 'Affiliation': 'Center for Global Health and Diseases, Case Western Reserve University School of Medicine, Cleveland, Ohio, USA.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz1050']
820,30295516,Efficacy of a computer-based cognitive training program to enhance planning skills in 5 to 7-year-old normally-developing children.,"We designed and evaluated the efficacy of a computer-based cognitive training program (Executive Function Enhancement Program [EFEP]) to stimulate executive functions through enhancing planning in normally-developing children. A total of 111 Colombian children participated in the study. Fifty-nine (53%) of the children were assigned to the experimental condition (application of the EFEP program) with two levels of planning performance, and fifty-two (47%) to the waiting list control condition with the same two levels of planning. The training program was applied three times a week over six weeks, with post-intervention assessment two weeks after the end of training. A follow-up assessment was carried out three months later. Results showed that the intervention program was particularly effective in the children with lower pre-intervention performance in planning, demonstrating that the program is an efficient therapeutic instrument for enhancing the executive function of planning in children between 5 and 7 years old.",2020,"Results showed that the intervention program was particularly effective in the children with lower pre-intervention performance in planning, demonstrating that the program is an efficient therapeutic instrument for enhancing the executive function of planning in children between 5 and 7 years old.","['5 to 7-year-old normally-developing children', '111 Colombian children participated in the study', 'normally-developing children']","['computer-based cognitive training program', 'computer-based cognitive training program (Executive Function Enhancement Program [EFEP']",['planning skills'],"[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4517538', 'cui_str': '111 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}]","[{'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}]",111.0,0.00838138,"Results showed that the intervention program was particularly effective in the children with lower pre-intervention performance in planning, demonstrating that the program is an efficient therapeutic instrument for enhancing the executive function of planning in children between 5 and 7 years old.","[{'ForeName': 'Sonia Gisela', 'Initials': 'SG', 'LastName': 'Ríos Cruz', 'Affiliation': 'Facultad de Psicología, Universidad Católica de Colombia, Bogotá, Colombia.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Olivares Pérez', 'Affiliation': 'Facultad de Ciencias de la Salud, Sección Psicología, Universidad de La Laguna, La Laguna, Spain.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Hernández Expósito', 'Affiliation': 'Facultad de Ciencias de la Salud, Sección Psicología, Universidad de La Laguna, La Laguna, Spain.'}, {'ForeName': 'Holman Diego', 'Initials': 'HD', 'LastName': 'Bolívar Barón', 'Affiliation': 'Facultad de Ingeniería, Universidad Católica de Colombia, Bogotá, Colombia.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Gillon Dowens', 'Affiliation': 'Faculty of Humanities and Social Sciences, University of Nottingham, Ningbo, China.'}, {'ForeName': 'Moisés', 'Initials': 'M', 'LastName': 'Betancort Montesinos', 'Affiliation': 'Facultad de Ciencias de la Salud, Sección Psicología, Universidad de La Laguna, La Laguna, Spain.'}]",Applied neuropsychology. Child,['10.1080/21622965.2018.1503959']
821,29846031,"PHARMacy-based interdisciplinary program for patients with Chronic Heart Failure (PHARM-CHF): rationale and design of a randomized controlled trial, and results of the pilot study.","We report the rationale and design of a community PHARMacy-based prospective randomized controlled interdisciplinary study for ambulatory patients with Chronic Heart Failure (PHARM-CHF) and results of its pilot study. The pilot study randomized 50 patients to a pharmacy-based intervention or usual care for 12 months. It demonstrated the feasibility of the design and showed reduced systolic blood pressure in the intervention group as indicator for improved medication adherence. The main study will randomize patients ≥60 years on stable pharmacotherapy including at least one diuretic and a history of heart failure hospitalization within 12 months. The intervention group will receive a medication review at baseline followed by regular dose dispensing of the medication, counselling regarding medication use and symptoms of heart failure. The control patients are unknown to the pharmacy and receive usual care. The primary efficacy endpoint is medication adherence, pre-specified as a significant difference of the proportion of days covered between the intervention and control group within 365 days following randomization using pharmacy claims data for three CHF medications (angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, beta-blockers, and mineralocorticoid receptor antagonists). The primary composite safety endpoint is days lost due to blindly adjudicated unplanned cardiovascular hospitalizations or death. Overall, 248 patients shall be randomized. The minimum follow-up is 12 months with an expected mean of 24 months. Based on the feasibility demonstrated in the pilot study, the randomized PHARM-CHF trial will test whether an interdisciplinary pharmacy-based intervention can safely improve medication adherence and will estimate the potential impact on clinical endpoints. ClinicalTrials.gov Identifier: NCT01692119.",2018,It demonstrated the feasibility of the design and showed reduced systolic blood pressure in the intervention group as indicator for improved medication adherence.,"['patients with Chronic Heart Failure (PHARM-CHF', 'ambulatory patients with Chronic Heart Failure (PHARM-CHF', '50 patients to a pharmacy-based intervention or usual care for 12\u2009months', 'patients ≥60\u2009years on stable pharmacotherapy including at least one diuretic and a history of heart failure hospitalization within 12\u2009months', '248 patients shall be randomized']",['PHARMacy-based interdisciplinary program'],"['medication adherence', 'CHF medications (angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, beta-blockers, and mineralocorticoid receptor antagonists', 'medication adherence, pre-specified', 'systolic blood pressure', 'days lost due to blindly adjudicated unplanned cardiovascular hospitalizations or death']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0264716', 'cui_str': 'Chronic heart failure (disorder)'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0031322', 'cui_str': 'Pharmacies'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0012798', 'cui_str': 'Diuretics'}, {'cui': 'C0455531', 'cui_str': 'H/O: heart failure'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}]","[{'cui': 'C0031322', 'cui_str': 'Pharmacies'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C0003015', 'cui_str': 'ACE Inhibitors'}, {'cui': 'C0034787', 'cui_str': 'Angiotensin receptor (substance)'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C1579268', 'cui_str': 'Mineralocorticoid Antagonists'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",50.0,0.0505236,It demonstrated the feasibility of the design and showed reduced systolic blood pressure in the intervention group as indicator for improved medication adherence.,"[{'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Laufs', 'Affiliation': 'Department of Cardiology, University Hospital, Leipzig University, Germany.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Griese-Mammen', 'Affiliation': 'Department of Medicine, ABDA\xa0-\xa0Federal Union of German Associations of Pharmacists, Berlin, Germany.'}, {'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Krueger', 'Affiliation': 'Department of Medicine, ABDA\xa0-\xa0Federal Union of German Associations of Pharmacists, Berlin, Germany.'}, {'ForeName': 'Angelika', 'Initials': 'A', 'LastName': 'Wachter', 'Affiliation': 'Department of Internal Medicine III\xa0-\xa0Cardiology, Angiology and Intensive Care Medicine, Saarland University Medical Centre, University of the Saarland, Homburg/Saar, Germany.'}, {'ForeName': 'Stefan D', 'Initials': 'SD', 'LastName': 'Anker', 'Affiliation': 'Division of Cardiology and Metabolism; Department of Cardiology (CVK); and Berlin-Brandenburg Center for Regenerative Therapies (BCRT); German Centre for Cardiovascular Research (DZHK) Partner Site Berlin, Charité Universitätsmedizin Berlin, Germany.'}, {'ForeName': 'Friedrich', 'Initials': 'F', 'LastName': 'Koehler', 'Affiliation': 'Centre for Cardiovascular Telemedicine, Department of Cardiology and Angiology, Charité Universitätsmedizin Berlin, Germany.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Rettig-Ewen', 'Affiliation': 'Schwemlinger Gemeinschaftspraxis, Merzig, Germany.'}, {'ForeName': 'Lea', 'Initials': 'L', 'LastName': 'Botermann', 'Affiliation': 'Department of Medicine, ABDA\xa0-\xa0Federal Union of German Associations of Pharmacists, Berlin, Germany.'}, {'ForeName': 'Dorothea', 'Initials': 'D', 'LastName': 'Strauch', 'Affiliation': 'Department of Medicine, ABDA\xa0-\xa0Federal Union of German Associations of Pharmacists, Berlin, Germany.'}, {'ForeName': 'Dietmar', 'Initials': 'D', 'LastName': 'Trenk', 'Affiliation': 'Department of Clinical Pharmacology, University Heart Centre Freiburg-Bad Krozingen, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Böhm', 'Affiliation': 'Department of Internal Medicine III\xa0-\xa0Cardiology, Angiology and Intensive Care Medicine, Saarland University Medical Centre, University of the Saarland, Homburg/Saar, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Schulz', 'Affiliation': 'Department of Medicine, ABDA\xa0-\xa0Federal Union of German Associations of Pharmacists, Berlin, Germany.'}]",European journal of heart failure,['10.1002/ejhf.1213']
822,31641831,Effects of public versus media responsibility messages on stigmatization of people with schizophrenia in an American adult sample.,"PURPOSE


People with mental illness suffer from the consequences of stigma. Interventions to reduce stigma should focus on alternative approaches that target false beliefs toward mental disorders. The effectiveness of two messages to reduce stigma toward schizophrenia was tested: a traditional public responsibility message that attributes stigma to public misunderstandings, and an alternative media responsibility message that attributes stigma to bias in media representations.
METHODS


An experiment with Americans (N = 448) randomly assigned to a public responsibility message, a media responsibility message, or a control condition. Participants in the two message conditions completed measures of guilt and reactance toward the media. Perceptions of personal responsibility and dangerousness, and social rejection intentions were assessed for all participants.
RESULTS


Both messages lowered perceptions of dangerousness and social rejection intentions, relative to control. The media responsibility generated more reactance toward the media than the public responsibility approach, but not more guilt. Reactance did not mediate message effects. Perceptions of personal responsibility were reduced after exposure to the public responsibility message, but only for participants with no prior contact with mental illness.
CONCLUSIONS


Both approaches reduced perceptions of dangerousness and social rejection intentions. Stigma reduction campaigns might segment the audience based on prior contact.",2020,"Perceptions of personal responsibility were reduced after exposure to the public responsibility message, but only for participants with no prior contact with mental illness.
","['people with schizophrenia in an American adult sample', 'participants with no prior contact with mental illness', 'People with mental illness suffer from the consequences of stigma']","['public versus media responsibility messages', 'public responsibility message, a media responsibility message, or a control condition']","['guilt and reactance toward the media', 'perceptions of dangerousness and social rejection intentions', 'Perceptions of personal responsibility and dangerousness, and social rejection intentions']","[{'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0332158', 'cui_str': 'Contact with (contextual qualifier) (qualifier value)'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C0686907', 'cui_str': 'Consequence of (contextual qualifier) (qualifier value)'}, {'cui': 'C0277787', 'cui_str': 'Stigma (finding)'}]","[{'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0018379', 'cui_str': 'Guilt'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0010968', 'cui_str': 'Dangerousness'}, {'cui': 'C0237827', 'cui_str': 'Social Rejection'}, {'cui': 'C0162425', 'cui_str': 'Intention'}]",448.0,0.0249898,"Perceptions of personal responsibility were reduced after exposure to the public responsibility message, but only for participants with no prior contact with mental illness.
","[{'ForeName': 'Thais M', 'Initials': 'TM', 'LastName': 'Zimbres', 'Affiliation': 'Department of Communication, University of California Davis, One Shields Ave., Davis, CA, 95616, USA. zimbres@ucdavis.edu.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Bell', 'Affiliation': 'Department of Communication, University of California Davis, One Shields Ave., Davis, CA, 95616, USA.'}, {'ForeName': 'Laramie D', 'Initials': 'LD', 'LastName': 'Taylor', 'Affiliation': 'Department of Communication, University of California Davis, One Shields Ave., Davis, CA, 95616, USA.'}]",Social psychiatry and psychiatric epidemiology,['10.1007/s00127-019-01788-6']
823,31615480,"HABIT efficacy and sustainability trial, a multi-center randomized controlled trial to improve hydroxyurea adherence in youth with sickle cell disease: a study protocol.","BACKGROUND


Hydroxyurea (HU) is recommended as standard practice for youth with sickle cell disease (SCD). Yet, despite its efficacy, HU adherence in adolescents and young adults is often poor. Poor medication adherence increases disease burden, healthcare cost and widens health disparities. Adolescence is a critical time to improve adherence through improved chronic disease self-management. This study aims to test the efficacy of an intervention delivered to youth/parent dyads by community health workers (CHWs), augmented by tailored text messages on HU adherence (primary outcome). Secondary outcomes are intervention sustainability, youth health-related quality of life, self-management responsibility concordance, acute hospital use and self-reported disease symptoms.
METHODS


Hydroxyurea Adherence for Personal Best in Sickle Cell Disease, ""HABIT,"" is a 12 month multi-center randomized controlled trial. One hundred four youth, 10 to 18 years of age prescribed HU who meet eligibility criteria, enrolled with their parent as dyads, will be randomized 1:1 to either the HABIT intervention or to usual clinical care plus education handouts. All subjects will complete clinic visits at months 0, 2, 4, 6 (efficacy component), 9 and 12 (sustainability component) for assessment of HbF biomarker, other hematologic parameters, and to complete questionnaires. In addition, dyads assigned to the HABIT intervention will work with CHWs to identify a daily habit (e.g., brushing teeth) on which to build a HU adherence habit. Tailored daily text message reminders to support the habit will be developed by the dyad in collaboration with the CHWs and sent to parent and youth. At the 6 month visit, the intervention will end and the sustainability portion of the trial will begin. All data analyses will be based on intention to treat with all randomized subjects included in the analyses.
DISCUSSION


Prior retrospective studies demonstrate that a majority of adolescents are poorly adherent to HU. If efficacious, the HABIT intervention has the potential to improve the lives of youth with SCD.
TRIAL REGISTRATION


Clinicaltrials.gov NCT03462511 . Registered March 6, 2018, last updated July 26, 2019.",2019,"Secondary outcomes are intervention sustainability, youth health-related quality of life, self-management responsibility concordance, acute hospital use and self-reported disease symptoms.
","['One hundred four youth, 10 to 18\u2009years of age prescribed HU who meet eligibility criteria, enrolled with their parent as dyads', 'adolescents and young adults', 'youth with sickle cell disease (SCD', 'youth with sickle cell disease']","['Hydroxyurea (HU', 'HABIT intervention or to usual clinical care plus education handouts', 'HABIT intervention', 'intervention delivered to youth/parent dyads by community health workers (CHWs', 'hydroxyurea adherence']","['HABIT efficacy', 'disease burden, healthcare cost and widens health disparities', 'intervention sustainability, youth health-related quality of life, self-management responsibility concordance, acute hospital use and self-reported disease symptoms']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0002895', 'cui_str': 'Sickle Cell Disease'}, {'cui': 'C0964695', 'cui_str': 's(7)(beta)CD'}]","[{'cui': 'C0020402', 'cui_str': 'hydroxyurea'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}]","[{'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",104.0,0.0982274,"Secondary outcomes are intervention sustainability, youth health-related quality of life, self-management responsibility concordance, acute hospital use and self-reported disease symptoms.
","[{'ForeName': 'Arlene', 'Initials': 'A', 'LastName': 'Smaldone', 'Affiliation': 'Columbia University School of Nursing, New York, NY, USA. ams130@columbia.edu.'}, {'ForeName': 'Deepa', 'Initials': 'D', 'LastName': 'Manwani', 'Affiliation': 'Albert Einstein College of Medicine, Bronx, NY, USA.'}, {'ForeName': 'Banu', 'Initials': 'B', 'LastName': 'Aygun', 'Affiliation': 'Zucker School of Medicine at Hofstra/Northwell, New Hyde Park, New York, USA.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Smith-Whitley', 'Affiliation': 'Perelman School of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Haomiao', 'Initials': 'H', 'LastName': 'Jia', 'Affiliation': 'Columbia University School of Nursing, New York, NY, USA.'}, {'ForeName': 'Jean-Marie', 'Initials': 'JM', 'LastName': 'Bruzzese', 'Affiliation': 'Columbia University School of Nursing, New York, NY, USA.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Findley', 'Affiliation': 'Mailman School of Public Health, New York, NY, USA.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Massei', 'Affiliation': 'Columbia University School of Nursing, New York, NY, USA.'}, {'ForeName': 'Nancy S', 'Initials': 'NS', 'LastName': 'Green', 'Affiliation': 'Vagelos College of Physicians and Surgeons, Columbia University, New York, NY, USA.'}]",BMC pediatrics,['10.1186/s12887-019-1746-6']
824,31630690,Effects of closed-loop automatic control of the inspiratory fraction of oxygen (FiO 2 -C) on outcome of extremely preterm infants - study protocol of a randomized controlled parallel group multicenter trial for safety and efficacy.,"BACKGROUND


Most extremely low gestational age neonates (ELGANS, postmenstrual age at birth (PMA) < 28 completed weeks) require supplemental oxygen and experience frequent intermittent hypoxemic and hyperoxemic episodes. Hypoxemic episodes and exposure to inadequately high concentrations of oxygen are associated with an increased risk of retinopathy of prematurity (ROP), chronic lung disease of prematurity (BPD), necrotizing enterocolitis (NEC), neurodevelopmental impairment (NDI), and death beyond 36 weeks PMA. Closed-loop automated control of the inspiratory fraction of oxygen (FiO 2 -C) reduces time outside the hemoglobin oxygen saturation (SpO 2 ) target range, number and duration of hypo- and hyperoxemic episodes and caregivers' workload. Effects on clinically important outcomes in ELGANs such as ROP, BPD, NEC, NDI and mortality have not yet been studied.
METHODS


An outcome-assessor-blinded, randomized controlled, parallel-group trial was designed and powered to study the effect of FiO 2 -C (in addition to routine manual control (RMC) of FiO 2 ), compared to RMC only, on death and severe complications related to hypoxemia and/or hyperoxemia. 2340 ELGANS with a GA of 23 + 0/7 to 27 + 6/7 weeks will be recruited in approximately 75 European tertiary care neonatal centers. Study participants are randomly assigned to RMC (control-group) or FiO 2 -C in addition to RMC (intervention-group). Central randomization is stratified for center, gender and PMA at birth (< 26 weeks and ≥ 26 weeks). FiO 2 -C is provided by commercially available and CE-marked ventilators with an FiO 2 -C algorithm intended for use in newborn infants. The primary outcome variable (composite of death, severe ROP, BPD or NEC) is assessed at 36 weeks PMA (or, in case of ROP, until complete vascularization of the retina, respectively). The co-primary outcome variable (composite outcome of death, language/cognitive delay, motor impairment, severe visual impairment or hearing impairment) is assessed at 24 months corrected age.
DISCUSSION


Short-term studies on FiO 2 -C showed improved time ELGANs spent within their assigned SpO 2  target range, but effects of FiO 2 -C on clinical outcomes are yet unknown and will be addressed in the FiO 2 -C trial. This will ensure an appropriate assessment of safety and efficacy before FiO 2 -C may be implemented as standard therapy.
TRIAL REGISTRATION


The study is registered at www.ClinicalTrials.gov: NCT03168516 , May 30, 2017.",2019,"Closed-loop automated control of the inspiratory fraction of oxygen (FiO 2 -C) reduces time outside the hemoglobin oxygen saturation (SpO 2 ) target range, number and duration of hypo- and hyperoxemic episodes and caregivers' workload.","['low gestational age neonates ', 'newborn infants', '2340']","['Closed-loop automated control of the inspiratory fraction of oxygen (FiO 2 -C', 'closed-loop automatic control of the inspiratory fraction of oxygen (FiO 2 -C', 'RMC (control-group) or FiO 2 -C in addition to RMC (intervention-group']","['death, language/cognitive delay, motor impairment, severe visual impairment or hearing impairment', 'risk of retinopathy of prematurity (ROP), chronic lung disease of prematurity (BPD), necrotizing enterocolitis (NEC), neurodevelopmental impairment (NDI), and death', 'composite of death, severe ROP, BPD or NEC', ""hemoglobin oxygen saturation (SpO 2 ) target range, number and duration of hypo- and hyperoxemic episodes and caregivers' workload"", 'ROP, BPD, NEC, NDI and mortality']","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}]","[{'cui': 'C0443183', 'cui_str': 'Closed loop (qualifier value)'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C1301509', 'cui_str': 'Severe visual impairment'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0035344', 'cui_str': 'Retrolental Fibroplasia'}, {'cui': 'C0006287', 'cui_str': 'Bronchopulmonary Dysplasia'}, {'cui': 'C0520459', 'cui_str': 'Necrotizing Enterocolitis'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0912341', 'cui_str': ""N'(OB)EC""}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",28.0,0.307759,"Closed-loop automated control of the inspiratory fraction of oxygen (FiO 2 -C) reduces time outside the hemoglobin oxygen saturation (SpO 2 ) target range, number and duration of hypo- and hyperoxemic episodes and caregivers' workload.","[{'ForeName': 'Christian A', 'Initials': 'CA', 'LastName': 'Maiwald', 'Affiliation': ""Department of Neonatology, University Children's Hospital Tübingen, Calwerstr. 7, 72076, Tübingen, Germany.""}, {'ForeName': 'Hendrik J', 'Initials': 'HJ', 'LastName': 'Niemarkt', 'Affiliation': 'Máxima Medical Centre Veldhoven, Veldhoven, The Netherlands.'}, {'ForeName': 'Christian F', 'Initials': 'CF', 'LastName': 'Poets', 'Affiliation': ""Department of Neonatology, University Children's Hospital Tübingen, Calwerstr. 7, 72076, Tübingen, Germany.""}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Urschitz', 'Affiliation': 'Institute of Medical Biostatistics, Epidemiology and Informatics, Medical Center of the Johannes Gutenberg-University Mainz, Mainz, Germany.'}, {'ForeName': 'Jochem', 'Initials': 'J', 'LastName': 'König', 'Affiliation': 'Institute of Medical Biostatistics, Epidemiology and Informatics, Medical Center of the Johannes Gutenberg-University Mainz, Mainz, Germany.'}, {'ForeName': 'Helmut', 'Initials': 'H', 'LastName': 'Hummler', 'Affiliation': ""Children's Hospital University of Ulm, Ulm, Germany.""}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Bassler', 'Affiliation': 'UniversitätsSpital Zürich, Zürich, Switzerland.'}, {'ForeName': 'Corinna', 'Initials': 'C', 'LastName': 'Engel', 'Affiliation': ""Center for Pediatric Clinical Studies (CPCS), University Children's Hospital Tübingen, Calwerstr. 7, 72076, Tübingen, Germany.""}, {'ForeName': 'Axel R', 'Initials': 'AR', 'LastName': 'Franz', 'Affiliation': ""Department of Neonatology, University Children's Hospital Tübingen, Calwerstr. 7, 72076, Tübingen, Germany. Axel.Franz@med.uni-tuebingen.de.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMC pediatrics,['10.1186/s12887-019-1735-9']
825,31347100,Simplifying Complex Insulin Regimens While Preserving Good Glycemic Control in Type 2 Diabetes.,"INTRODUCTION


Type 2 diabetic patients suffering from severe hyperglycemia are often assigned a regimen involving multiple daily injections (MDI) of insulin. If the glucose toxicity resolves, the regimen can potentially be simplified, but there are no guidelines for this, and many patients are left on the MDI regimen. We aimed to prospectively examine the safety and efficacy of switching from MDI to once-daily IDegLira, a fixed-ratio combination of insulin degludec and liraglutide, in relatively well controlled (HbA1c ≤ 7.5%) subjects with type 2 diabetes on a low total daily insulin dose (TDD).
METHODS


62 adults with type 2 diabetes (baseline age 64.06 ± 10.24 years, HbA 1c  6.42 ± 0.68%, BMI 33.53 ± 6.90 kg/m 2 , body weight 93.81 ± 19.26 kg, TDD 43.31 ± 10.99 IU/day, insulin requirement 0.47 ± 0.13 IU/kg, duration of diabetes 10.84 ± 7.50 years, mean ± SD) treated with MDI ± metformin were enrolled in our study. Previous insulins were stopped and once-daily IDegLira was started. IDegLira was titrated by the patients to achieve a self-measured pre-breakfast blood glucose concentration of < 6 mmol/L.
RESULTS


After a mean follow-up period of 99.2 days, mean HbA 1c  had decreased by 0.30% to 6.12 ± 0.65% (p < 0.0001), body weight had decreased by 3.11 kg to 90.70 ± 19.12 kg (p < 0.0001), and BMI had reduced to 32.39 ± 6.71 kg/m 2  (p < 0.0001). After 3 months of treatment, the mean dose of IDegLira was 20.76 ± 6.60 units and the mean insulin requirement had decreased to 0.23 ± 0.08 IU/kg. IDegLira ± metformin combination therapy was found to be safe and generally well tolerated. During the month before the baseline visit, 28 patients (45%) had at least one episode of documented or symptomatic hypoglycemia, while only 6 (9.67%) patients reported a total of 13 documented episodes during the follow-up.
CONCLUSION


In everyday clinical practice, switching from low-dose MDI to IDegLira in patients with well-controlled type 2 diabetes is safe, may result in weight loss and similar or better glycemic control, and substantially reduces the insulin requirement. Simplifying complex treatment regimens decreases treatment burden and may improve adherence to therapy.
CLINICAL TRIAL NUMBER


NCT04020445.",2019,IDegLira ± metformin combination therapy was found to be safe and generally well tolerated.,"['relatively well controlled (HbA1c\u2009≤\u20097.5%) subjects with type 2 diabetes on a low total daily insulin dose (TDD', 'patients with well-controlled type 2 diabetes', 'diabetic patients suffering from severe hyperglycemia', 'Type 2 Diabetes', '62 adults with type 2 diabetes (baseline age 64.06\u2009±\u200910.24\xa0years, HbA 1c  6.42\u2009±\u20090.68%, BMI 33.53\u2009±\u20096.90\xa0kg/m 2 , body weight 93.81\u2009±\u200919.26\xa0kg, TDD 43.31\u2009±\u200910.99\xa0IU/day, insulin requirement 0.47\u2009±\u20090.13\xa0IU/kg, duration of diabetes 10.84\u2009±\u20097.50\xa0years, mean\u2009±\u2009SD) treated with MDI\u2009±']","['metformin combination therapy', 'metformin', 'switching from MDI to once-daily IDegLira, a fixed-ratio combination of insulin degludec and liraglutide']","['IDegLira', 'mean dose of IDegLira', 'symptomatic hypoglycemia', 'mean insulin requirement', 'BMI', 'safe and generally well tolerated', 'mean HbA 1c', 'body weight', 'safety and efficacy']","[{'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C4517859', 'cui_str': 'Seven point five'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0183841', 'cui_str': 'Telecommunications Devices for the Deaf'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3853142', 'cui_str': 'Well controlled'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C4517473', 'cui_str': '0.68'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0439465', 'cui_str': 'IU/day'}, {'cui': 'C4517428', 'cui_str': '0.13 (qualifier value)'}, {'cui': 'C0439463', 'cui_str': 'international unit/kilogram'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0993596', 'cui_str': 'Metered Dose Inhaler'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}, {'cui': 'C0993596', 'cui_str': 'Metered Dose Inhaler'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C4308663', 'cui_str': 'IDegLira'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C4059165', 'cui_str': 'insulin degludec / liraglutide'}]","[{'cui': 'C4308663', 'cui_str': 'IDegLira'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",62.0,0.0433742,IDegLira ± metformin combination therapy was found to be safe and generally well tolerated.,"[{'ForeName': 'Zoltán', 'Initials': 'Z', 'LastName': 'Taybani', 'Affiliation': '1st Department of Endocrinology, Dr. Réthy Pál Member Hospital, Békés County Central Hospital, Gyulai street 18, Békéscsaba, 5600, Hungary. taybanizoltan@gmail.com.'}, {'ForeName': 'Balázs', 'Initials': 'B', 'LastName': 'Bótyik', 'Affiliation': '1st Department of Endocrinology, Dr. Réthy Pál Member Hospital, Békés County Central Hospital, Gyulai street 18, Békéscsaba, 5600, Hungary.'}, {'ForeName': 'Mónika', 'Initials': 'M', 'LastName': 'Katkó', 'Affiliation': 'Division of Endocrinology, Department of Internal Medicine, Faculty of Medicine, University of Debrecen, Nagyerdei krt. 98, Debrecen, 4032, Hungary.'}, {'ForeName': 'András', 'Initials': 'A', 'LastName': 'Gyimesi', 'Affiliation': '1st Department of Endocrinology, Dr. Réthy Pál Member Hospital, Békés County Central Hospital, Gyulai street 18, Békéscsaba, 5600, Hungary.'}, {'ForeName': 'Tamás', 'Initials': 'T', 'LastName': 'Várkonyi', 'Affiliation': '1st Department of Internal Medicine, University of Szeged, Korányi fasor 8, Szeged, 6720, Hungary.'}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-019-0673-8']
826,29484198,Physical therapy and deep brain stimulation in Parkinson's Disease: protocol for a pilot randomized controlled trial.,"Background


Subthalamic nucleus deep brain stimulation (STN-DBS) reduces tremor, muscle stiffness, and bradykinesia in people with Parkinson's Disease (PD). Walking speed, known to be reduced in PD, typically improves after surgery; however, other important aspects of gait may not improve. Furthermore, balance may worsen and falls may increase after STN-DBS. Thus, interventions to improve balance and gait could reduce morbidity and improve quality of life following STN-DBS. Physical therapy (PT) effectively improves balance and gait in people with PD, but studies on the effects of PT have not been extended to those treated with STN-DBS. As such, the efficacy, safety, and feasibility of PT in this population remain to be determined. The purpose of this pilot study is to address these unmet needs. We hypothesize that PT designed to target balance and gait impairment will be effective, safe, and feasible in this population.
Methods/design


Participants with PD treated with STN-DBS will be randomly assigned to either a PT or control group. Participants assigned to PT will complete an 8-week, twice-weekly PT program consisting of exercises designed to improve balance and gait. Control group participants will receive the current standard of care following STN-DBS, which does not include prescription of PT. The primary aim is to assess preliminary efficacy of PT on balance (Balance Evaluation Systems Test). A secondary aim is to assess efficacy of PT on gait (GAITRite instrumented walkway). Participants will be assessed OFF medication/OFF stimulation and ON medication/ON stimulation at baseline and at 8 and 12 weeks after baseline. Adverse events will be measured over the duration of the study, and adherence to PT will be measured to determine feasibility.
Discussion


To our knowledge, this will be the first study to explore the preliminary efficacy, safety, and feasibility of PT for individuals with PD with STN-DBS. If the study suggests potential efficacy, then this would justify larger trials to test effectiveness and safety of PT for those with PD with STN-DBS.
Trial registration


NCT03181282 (clinicaltrials.gov). Registered on 7 June 2017.",2018,"Background


Subthalamic nucleus deep brain stimulation (STN-DBS) reduces tremor, muscle stiffness, and bradykinesia in people with Parkinson's Disease (PD).","[""Parkinson's Disease"", 'individuals with PD with STN-DBS', 'people with PD', 'Participants with PD treated with STN-DBS', ""people with Parkinson's Disease (PD""]","['PT', 'Physical therapy (PT', 'Physical therapy and deep brain stimulation', '\n\n\nSubthalamic nucleus deep brain stimulation (STN-DBS']","['balance and gait', 'Adverse events', 'efficacy, safety, and feasibility of PT', 'OFF medication/OFF stimulation and ON medication/ON stimulation', 'quality of life']","[{'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0394162', 'cui_str': 'Deep Brain Stimulation'}, {'cui': 'C0152355', 'cui_str': 'Nucleus Subthalamicus'}]","[{'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0034380'}]",,0.0750635,"Background


Subthalamic nucleus deep brain stimulation (STN-DBS) reduces tremor, muscle stiffness, and bradykinesia in people with Parkinson's Disease (PD).","[{'ForeName': 'Ryan P', 'Initials': 'RP', 'LastName': 'Duncan', 'Affiliation': '1Program in Physical Therapy, Washington University School of Medicine in Saint Louis, Campus Box 8502, 4444 Forest Park Blvd, St. Louis, MO 63108 USA.'}, {'ForeName': 'Linda R', 'Initials': 'LR', 'LastName': 'Van Dillen', 'Affiliation': '1Program in Physical Therapy, Washington University School of Medicine in Saint Louis, Campus Box 8502, 4444 Forest Park Blvd, St. Louis, MO 63108 USA.'}, {'ForeName': 'Jane M', 'Initials': 'JM', 'LastName': 'Garbutt', 'Affiliation': '4Department of Medicine, Washington University School of Medicine in Saint Louis, St. Louis, MO USA.'}, {'ForeName': 'Gammon M', 'Initials': 'GM', 'LastName': 'Earhart', 'Affiliation': '1Program in Physical Therapy, Washington University School of Medicine in Saint Louis, Campus Box 8502, 4444 Forest Park Blvd, St. Louis, MO 63108 USA.'}, {'ForeName': 'Joel S', 'Initials': 'JS', 'LastName': 'Perlmutter', 'Affiliation': '1Program in Physical Therapy, Washington University School of Medicine in Saint Louis, Campus Box 8502, 4444 Forest Park Blvd, St. Louis, MO 63108 USA.'}]",Pilot and feasibility studies,['10.1186/s40814-018-0243-2']
827,29609017,Enhancing predicted fluoride varnish efficacy and post-treatment compliance by means of calcium-containing gummy bears.,"OBJECTIVES


This study determined whether consumption of calcium-containing gummies prior to fluoride varnish application enhances plaque fluoride retention and compliance with post-varnish application instructions.
METHODS


The present study followed a multi-center, parallel, randomized, and laboratory analyst-blind design. Following IRB approval, parent consent and child assent, 44 subjects (7-12 years), were randomized to either gummy or no-gummy study groups. A baseline plaque sample was obtained after a wash-out period. Fluoride varnish (5% NaF) was applied; subjects in the gummy group received two calcium-containing gummies prior to varnish application. Subjects were given two questionnaires to complete (subject and parent) to investigate adherence to post-treatment instructions. Three days later, a second plaque sample was obtained. Plaque was analyzed for plaque fluid and solid fluoride concentrations. Fluoride data were analyzed using Wilcoxon Rank Sum tests, questionnaire data using Pearson chi-square tests.
RESULTS


Plaque fluid fluoride did not change pre- to post-treatment in the gummy group (mean ± sd: 8.8 ± 5.7 μmol/l vs. 10.0 ± 6.3 μmol/l; p = 0.265) or in the no-gummy group (8.1 ± 4.4 μmol/l vs. 16.1 ± 20.0 μmol/l; p = 0.058). Groups were not different for plaque fluid fluoride pre-treatment (p = 1.000), post-treatment (p = 0.904), or change (p = 0.904). Plaque solid fluoride did not change pre- to post-treatment in the gummy group (0.89 ± 1.10 μmol/g vs. 1.37 ± 1.77 μmol/g; p = 0.073) or in the no-gummy group (0.68 ± 0.77 μmol/g vs. 2.01 ± 5.00 μmol/g; p = 0.190). Groups were not different for plaque solid fluoride pre-treatment (p = 1.000), post-treatment (p = 0.466), or change (p = 0.874). No significant differences were found between groups for questionnaire responses.
CONCLUSION


This study failed to demonstrate an effect of calcium-containing gummies in enhancing plaque fluoride retention.
CLINICAL SIGNIFICANCE


The consumption of calcium-containing gummies prior to fluoride varnish application does not promote greater intra-oral fluoride retention or better adherence to post-treatment instructions.",2018,"Groups were not different for plaque fluid fluoride pre-treatment (p = 1.000), post-treatment (p = 0.904), or change (p = 0.904).",['44 subjects (7-12 years'],"['calcium-containing gummies', 'Fluoride varnish (5% NaF', 'calcium-containing gummies prior to varnish application']","['fluoride varnish efficacy', 'Wilcoxon Rank Sum tests, questionnaire data using Pearson chi-square tests', 'Plaque solid fluoride', 'questionnaire responses']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0016326', 'cui_str': 'Fluoride Varnishes'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0042359', 'cui_str': 'Varnish'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}]","[{'cui': 'C0016326', 'cui_str': 'Fluoride Varnishes'}, {'cui': 'C0242928', 'cui_str': 'Rank-Sum Tests'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0008041', 'cui_str': 'Chi-Square Test'}, {'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0302909', 'cui_str': 'Solid substance (substance)'}, {'cui': 'C0016327', 'cui_str': 'Fluorides'}]",44.0,0.0458442,"Groups were not different for plaque fluid fluoride pre-treatment (p = 1.000), post-treatment (p = 0.904), or change (p = 0.904).","[{'ForeName': 'F', 'Initials': 'F', 'LastName': 'Lippert', 'Affiliation': 'Department of Cariology, Operative Dentistry and Dental Public Health, Indiana University School of Dentistry, 1121 W Michigan St, Indianapolis, IN, 46202, USA. Electronic address: flippert@iu.edu.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Al Dehailan', 'Affiliation': 'Department of Cariology, Operative Dentistry and Dental Public Health, Indiana University School of Dentistry, 1121 W Michigan St, Indianapolis, IN, 46202, USA; Department of Restorative Dental Sciences, College of Dentistry, Imam Abdulrahman Bin Faisal University, 2835 King Faisal Road, Dammam 34212, Saudi Arabia.'}, {'ForeName': 'G A', 'Initials': 'GA', 'LastName': 'Castiblanco', 'Affiliation': 'Department of Cariology, Operative Dentistry and Dental Public Health, Indiana University School of Dentistry, 1121 W Michigan St, Indianapolis, IN, 46202, USA.'}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Tagelsir', 'Affiliation': 'Department of Cariology, Operative Dentistry and Dental Public Health, Indiana University School of Dentistry, 1121 W Michigan St, Indianapolis, IN, 46202, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Buckley', 'Affiliation': 'Department of Cariology, Operative Dentistry and Dental Public Health, Indiana University School of Dentistry, 1121 W Michigan St, Indianapolis, IN, 46202, USA.'}, {'ForeName': 'G J', 'Initials': 'GJ', 'LastName': 'Eckert', 'Affiliation': 'Department of Biostatistics, Indiana University School of Medicine, 410 W. Tenth St., Suite 3000, Indianapolis, IN, 46202, USA.'}]",Journal of dentistry,['10.1016/j.jdent.2018.03.015']
828,29472362,"Open-label, multicentre, dose-escalating phase II clinical trial on the safety and efficacy of tadekinig alfa (IL-18BP) in adult-onset Still's disease.","OBJECTIVES


Adult-onset Still's disease (AOSD) is a rare systemic autoinflammatory disease; its management is largely empirical. This is the first clinical study to determine if interleukin (IL)-18 inhibition, using the recombinant human IL-18 binding protein, tadekinig alfa, is a therapeutic option in AOSD.
METHODS


In this phase II, open-label study, patients were ≥18 years with active AOSD plus fever or C reactive protein (CRP) levels ≥10 mg/L despite treatment with prednisone and/or conventional synthetic disease-modifying antirheumatic drugs (DMARDs). Previous biological DMARD treatment was permitted. Patients received tadekinig alfa 80 mg or 160 mg subcutaneously three times per week for 12 weeks; those receiving 80 mg not achieving early predicted response criteria (reduction of ≥50% CRP values from baseline and fever resolution) were up-titrated to 160 mg for a further 12 weeks. The primary endpoint was the occurrence of adverse events (AEs) throughout the study.
RESULTS


Ten patients were assigned to receive 80 mg tadekinig alfa and 13 patients to the 160 mg dose. One hundred and fifty-five treatment-emerging AEs were recorded, and 47 were considered related to the study drug. Most AEs were mild and resolved after drug discontinuation. Three serious AEs occurred, one possibly related to treatment (toxic optic neuropathy). At week 3, 5 of 10 patients receiving 80 mg and 6 of 12 patients receiving 160 mg achieved the predefined response criteria.
CONCLUSIONS


Our results indicate that tadekinig alfa appears to have a favourable safety profile and is associated with early signs of efficacy in patients with AOSD.
TRIAL REGISTRATION NUMBER


NCT02398435.",2018,"At week 3, 5 of 10 patients receiving 80 mg and 6 of 12 patients receiving 160 mg achieved the predefined response criteria.
","['One hundred and fifty-five treatment-emerging AEs were recorded, and 47 were considered related to the study drug', ""adult-onset Still's disease"", ""Adult-onset Still's disease (AOSD"", 'patients with AOSD', 'patients were ≥18 years with active AOSD plus fever or C reactive protein ']","['tadekinig alfa (IL-18BP', '80\u2009mg tadekinig alfa', 'tadekinig alfa 80\u2009mg or 160\u2009mg subcutaneously three times per week for 12 weeks; those receiving 80\u2009mg not achieving early predicted response criteria (reduction of ≥50%\u2009CRP', 'prednisone and/or conventional synthetic disease-modifying antirheumatic drugs (DMARDs']","['CRP) levels ≥10', 'occurrence of adverse events (AEs']","[{'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0085253', 'cui_str': 'Adult-Onset Still Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}]","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0242708', 'cui_str': 'Antirheumatic Drugs, Disease-Modifying'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",10.0,0.0511698,"At week 3, 5 of 10 patients receiving 80 mg and 6 of 12 patients receiving 160 mg achieved the predefined response criteria.
","[{'ForeName': 'Cem', 'Initials': 'C', 'LastName': 'Gabay', 'Affiliation': 'Department of Internal Medicine Specialties, Division of Rheumatology, University Hospitals of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Fautrel', 'Affiliation': 'UPMC, Pierre Louis Institute of Epidemiology and Public Health, GRC 08, Paris, France.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Rech', 'Affiliation': 'Department of Internal Medicine 3, Rheumatology and Immunology, Universitätsklinikum Erlangen, Erlangen, Germany.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Spertini', 'Affiliation': 'Division of Immunology and Allergy, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland.'}, {'ForeName': 'Eugen', 'Initials': 'E', 'LastName': 'Feist', 'Affiliation': 'Charité Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin, Germany.'}, {'ForeName': 'Ina', 'Initials': 'I', 'LastName': 'Kötter', 'Affiliation': 'Department of Internal Medicine/Rheumatology, Nephrology and Immunology, Asklepios Klinikum, Hamburg, Germany.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Hachulla', 'Affiliation': 'Department of Internal Medicine, University of Lille, Lille, France.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Morel', 'Affiliation': 'Department of Rheumatology, University and CHU of Montpellier, Montpellier, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Schaeverbeke', 'Affiliation': 'Department of Rheumatology, FHU Acronim, CHU of Bordeaux, Bordeaux, France.'}, {'ForeName': 'Mohamed A', 'Initials': 'MA', 'LastName': 'Hamidou', 'Affiliation': 'Department of Internal Medicine, CHU Nantes, Nantes, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Martin', 'Affiliation': 'Department of Clinical Immunology and Internal Medicine, CHU of Strasbourg, Strasbourg, France.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Hellmich', 'Affiliation': 'Department of Internal Medicine, Rheumatology and Immunology, Medius Klinik Kirchheim, Kirchheim unter Teck, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lamprecht', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Hendrik', 'Initials': 'H', 'LastName': 'Schulze-Koops', 'Affiliation': 'Department of Internal Medicine IV, Division of Rheumatology and Clinical Immunology, Ludwig-Maximilians-University, Munich, Germany.'}, {'ForeName': 'Delphine Sophie', 'Initials': 'DS', 'LastName': 'Courvoisier', 'Affiliation': 'Department of Internal Medicine Specialties, Division of Rheumatology, University Hospitals of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Sleight', 'Affiliation': 'AB2 Bio Ltd, EPFL Innovation Park, Lausanne, Switzerland.'}, {'ForeName': 'Eduardo Jorge', 'Initials': 'EJ', 'LastName': 'Schiffrin', 'Affiliation': 'AB2 Bio Ltd, EPFL Innovation Park, Lausanne, Switzerland.'}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2017-212608']
829,29168127,Bioavailability of Orally Administered Des-Aspartate-Angiotensin I in Human Subjects.,"In an earlier single-dose escalation study to evaluate the safety and pharmacokinetics of orally administered des-aspartate-angiotensin I (DAA-I) in healthy subjects, the plasma level of DAA-I could not be determined because DAA-I is rapidly degraded in the circulation. The present study investigated the oral bioavailability of DAA-I by measuring the prostaglandin E 2  metabolite (PGEM) in the plasma samples of the same trial. PGEM is a stable derivative of PGE 2 , which has been shown to be a biomarker of DAA-I. The data show that plasma from two of the three subjects who were orally administered the efficacious preclinical dose of 0.70 mg/kg DAA-I exhibited a significant PGEM peak at 5-6 h postdose. Plasma of subjects who were administered 0.08 and 1.5 mg/kg DAA-I, the subefficacious and two-times efficacious dose, respectively, did not exhibit a similar PGEM peak. This observation is concordant with the known in vivo actions of DAA-I, especially its hypoglycemic action where maximum efficacy occurred at a dose of 0.7 mg/kg, and decreased to nil at the two-times efficacious dose. The onset of the PGEM peak at 5-6 h postdose was closed to the 4-h onset of absorption of [C 14 ]DAA-I seen in preclinical rat studies, albeit the absorption kinetics between rodents and humans are not identical. The occurrence of polymorphism of enzymes involved in the formation and degradation of PGE 2  is common, and this has been attributed to contributing to the variation in response, onset and peak PGEM observed among the three subjects who were administered the efficacious dose.",2018,"Plasma of subjects who were administered 0.08 and 1.5 mg/kg DAA-I, the subefficacious and two-times efficacious dose, respectively, did not exhibit a similar PGEM peak.","['healthy subjects', 'I in Human Subjects']","['Bioavailability of Orally Administered Des-Aspartate-Angiotensin', 'orally administered des-aspartate-angiotensin I (DAA-I', 'PGEM']",['PGEM peak'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0080105', 'cui_str': 'Human Subjects'}]","[{'cui': 'C0005508', 'cui_str': 'Bioavailability'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0085845', 'cui_str': 'Aspartate'}, {'cui': 'C0003018', 'cui_str': 'Angiotensins'}, {'cui': 'C2354314', 'cui_str': 'des-aspartate-angiotensin I'}]","[{'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}]",,0.0452657,"Plasma of subjects who were administered 0.08 and 1.5 mg/kg DAA-I, the subefficacious and two-times efficacious dose, respectively, did not exhibit a similar PGEM peak.","[{'ForeName': 'Kok-Onn', 'Initials': 'KO', 'LastName': 'Lee', 'Affiliation': 'Department of Medicine, National University of Singapore, 1E Kent Ridge Road, NUHS Tower Block Level 10, Singapore, 119228, Singapore.'}, {'ForeName': 'Edmund Feng', 'Initials': 'EF', 'LastName': 'Tian', 'Affiliation': 'School of Applied Science, Temasek Polytechnic, 21 Tampines Avenue 1, Singapore, 529757, Singapore.'}, {'ForeName': 'Martin Hui', 'Initials': 'MH', 'LastName': 'Cai', 'Affiliation': 'School of Applied Science, Temasek Polytechnic, 21 Tampines Avenue 1, Singapore, 529757, Singapore.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Singapore Nuclear Research and Safety Initiative, National University of Singapore, 1 CREATE Way, #04-01 CREATE Tower, Singapore, 138602, Singapore.'}, {'ForeName': 'Yiong-Huak', 'Initials': 'YH', 'LastName': 'Chan', 'Affiliation': 'Biostatistics Unit, Yong Loo Lin School of Medicine, National University Health System, 1E Kent Ridge Road, NUHS Tower Block Level 11, Singapore, 119228, Singapore.'}, {'ForeName': 'Meng-Kwoon', 'Initials': 'MK', 'LastName': 'Sim', 'Affiliation': 'Department of Pharmacology, Yong Loo Lin School of Medicine, Block MD 3 Level 4 #04-01, 16 Medical Drive, Singapore, 117600, Singapore. simmk@alumni.nus.edu.sg.'}]",Drugs in R&D,['10.1007/s40268-017-0218-4']
830,31628860,Nonsteroidal anti-inflammatory drugs for assisted reproductive technology.,"BACKGROUND


Despite substantial improvements in the success of treatments through assisted reproduction technologies (ART), live birth rates remain constantly low, and practitioners are seeking aetiologic treatments to improve the outcomes.Local inflammatory response is believed to contribute to implantation failure, where prostaglandins may increase uterine contractions and decrease uterine receptivity, decreasing the possibility of an IVF cycle leading to successful embryo transfer. In this context, nonsteroidal anti-inflammatory drugs (NSAIDs) have been employed to inhibit the negative prostaglandin effect. They are often offered in clinical practice to improve ART outcomes, but current robust evidence on their efficacy is lacking.
OBJECTIVES


To evaluate the effectiveness and safety of nonsteroidal anti-inflammatory drugs as co-treatments in infertile women undergoing assisted reproduction, in terms of improving live birth and miscarriage rates.
SEARCH METHODS


We designed the search using standard Cochrane methods and performed it on databases from their inception to 20 February 2019.We searched the Cochrane Gynaecology and Fertility Group Specialised Register of controlled trials, CENTRAL via the Cochrane Central Register of Studies Online, MEDLINE, Embase, CINAHL, and the trial registers for ongoing and registered trials, grey literature and treatment guidelines. We handsearched reference lists of relevant systematic reviews and RCTs, and PubMed and Google for any recent trials. There were no restrictions by language or country of origin.
SELECTION CRITERIA


All RCTs on the use of NSAIDs as co-treatment during an ART cycle compared with no use or the use of placebo or any other similar drug, along with the comparison of any NSAID to another.
DATA COLLECTION AND ANALYSIS


We used standard methodological procedures recommended by Cochrane. Our primary outcomes were live birth/ongoing pregnancy and miscarriage. We performed statistical analysis using Review Manager 5. We assessed evidence quality using GRADE methods.
MAIN RESULTS


We found 11 RCTs (1884 women) suitable for inclusion in the review. Most studies were at unclear or high risk of bias. The main limitations in the overall quality of the evidence were high risk of bias, unexplained heterogeneity and serious imprecision and indirectness.There were no data on our primary outcome - live birth per woman randomised - in any review comparisons.NSAIDs vs. placebo/no treatmentWe are uncertain of an effect on ongoing pregnancy when NSAIDs were compared to placebo/no treatment (risk ratio (RR) 1.06, 95% confidence interval (CI) 0.71 to 1.59; 4 studies, 1159 participants; I² = 53%; very low quality evidence). Results suggest that if the chance of ongoing pregnancy following placebo or no treatment is assumed to be 15%, the chance following the use of NSAIDs is estimated to be between 12% and 24%. Subgroup analysis according to the type of NSAID yielded similar results.We are also uncertain of an effect on miscarriage rates when NSAIDs were compared to placebo/no treatment (RR 0.62, 95% CI 0.33 to 1.16; 4 studies, 525 participants; I² = 43%; very low quality evidence). Results suggest that if the chance of miscarriage following placebo or no treatment is assumed to be 21%, the chance following the use of NSAIDs is estimated to be between 7% and 27%. The results were similar when two studies were excluded due to high risk of bias.Concerning the secondary outcomes, we are uncertain of an effect on clinical pregnancy rates (RR 1.23, 95% CI 1.00 to 1.52; 6 studies, 1570 participants; I² = 49%; low-quality evidence); on ectopic pregnancy (RR 0.56, 95% CI 0.05 to 5.89; 1 study, 72 participants); on multiple pregnancy (RR 2.00, 95% CI 0.18 to 21.67; 1 study, 180 participants); and on side effects (RR 1.39, 95% CI 0.02 to 119.35; 3 studies, 418 participants; I² = 79%). The evidence suggests that if the chance of clinical pregnancy following placebo or no treatment is assumed to be 30%, the chance following the use of NSAIDs is estimated to be between 31% and 45%. If the chance of ectopic pregnancy following placebo or no treatment is assumed to be 5%, the chance following the use of NSAIDs is estimated to be between 0.3% and 31%. If the chance of multiple pregnancy following placebo or no treatment is assumed to be 1%, the chance following the use of NSAIDs is estimated to be between 0.2 % and 24%.There were no cases of congenital anomalies during antenatal ultrasound screening of the women in one study.NSAID vs. another NSAIDOnly one study compared piroxicam with indomethacin: we are uncertain of an effect on ongoing pregnancy (RR 1.12, 95% CI 0.63 to 2.00; 1 study, 170 participants; very low quality evidence); and on miscarriage (RR 1.00, 95% CI 0.44 to 2.28; 1 study, 170 participants; very low quality evidence). The evidence suggests that if the chance of ongoing pregnancy following indomethacin is assumed to be 20%, the chance following the use of piroxicam is estimated to be between 13% and 40%; while for miscarriage, the evidence suggests that if the chance following indomethacin is assumed to be 12%, the chance following the use of piroxicam is estimated to be between 5% and 27%.Similar results were reported for clinical pregnancy (RR 1.07, 95% CI 0.71 to 1.63; 1 study, 170 participants; very low quality evidence).There were no data for the other outcomes specified in this review.NSAID vs. aspirinNo study reported this comparison.
AUTHORS' CONCLUSIONS


Currently we are uncertain of an effect of the routine use of NSAIDs as co-treatments in infertile women undergoing assisted reproduction in order to improve ongoing pregnancy and miscarriage rates. This is based on available data from RCTs, where very low quality evidence showed that there is no single outcome measure demonstrating a benefit with their use. Further large, well-designed randomised placebo-controlled trials reporting on live births are required to clarify the exact role of NSAIDs.",2019,": we are uncertain of an effect on ongoing pregnancy (RR 1.12, 95% CI 0.63 to 2.00; 1 study, 170 participants; very low quality evidence); and on miscarriage (RR 1.00, 95% CI 0.44 to 2.28; 1 study, 170 participants; very low quality evidence).","['11 RCTs (1884 women) suitable for inclusion in the review', 'infertile women undergoing assisted reproduction']","['Nonsteroidal anti-inflammatory drugs', 'piroxicam', 'nonsteroidal anti-inflammatory drugs', 'placebo', 'indomethacin', 'NSAIDs vs. placebo']","['clinical pregnancy', 'clinical pregnancy rates', 'side effects', 'live birth/ongoing pregnancy and miscarriage', 'live birth and miscarriage rates', 'effectiveness and safety', 'multiple pregnancy', 'ectopic pregnancy', 'miscarriage rates']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0021359', 'cui_str': 'Infertility'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0031990', 'cui_str': 'Piroxicam'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0021246', 'cui_str': 'Indomethacin'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0481667', 'cui_str': 'Live Birth'}, {'cui': 'C0000786', 'cui_str': 'Vaginal expulsion of product of conception'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0032989', 'cui_str': 'Multiple Pregnancy'}, {'cui': 'C0032987', 'cui_str': 'Ectopic Pregnancy'}]",525.0,0.454739,": we are uncertain of an effect on ongoing pregnancy (RR 1.12, 95% CI 0.63 to 2.00; 1 study, 170 participants; very low quality evidence); and on miscarriage (RR 1.00, 95% CI 0.44 to 2.28; 1 study, 170 participants; very low quality evidence).","[{'ForeName': 'Atunga', 'Initials': 'A', 'LastName': 'Nyachieo', 'Affiliation': 'Reproductive health and Biology, Institute of Primate Research, POBox 24481-00502, Karen, Nairobi, Kenya.'}, {'ForeName': 'Charalampos S', 'Initials': 'CS', 'LastName': 'Siristatidis', 'Affiliation': ''}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Vaidakis', 'Affiliation': ''}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD007618.pub2']
831,31625480,"First-in-Human Study of the Safety, Tolerability, Pharmacokinetics and - Preliminary Dynamics of Neuroprotectant 2-Iminobiotin in Healthy Subjects.","BACKGROUND


2-iminobiotin (2-IB) is an investigational neuroprotective agent in development for the reduction of brain cell injury after cerebral hypoxia-ischemia.
OBJECTIVE


The present first-in-human study evaluated the safety, tolerability, pharmacokinetics (PK) and -dynamics (PD) of 2-IB in healthy male subjects, intravenously infused with or without Captisol® as a solubilizing agent.
METHODS


This randomized, double-blind, placebo-controlled, dose-escalation study was executed in 2 groups of 9 healthy male subjects. A single dose of 2-IB 0.6 mg/kg or placebo was infused over periods between 15 min and 4 h, and repeated doses escalating from 0.6 mg/kg to 12 mg/kg, or placebo were infused every 4 h for 6 administrations in total.
RESULTS


Single and multiple doses of 2-IB up to 6 doses of 6 mg/kg with and without Captisol® were safe and well-tolerated in healthy male subjects. 2-IB proved to be a high-clearance drug with a volume of distribution slightly exceeding total body water volume, and with linear PK that appeared not to be affected by the presence of Captisol®.
CONCLUSION


Sulfobutyletherbeta-cyclodextrin (SBECD) in Captisol® had a low-clearance profile with a small volume of distribution, with time-independent PK. Preliminary PD characterization of repeated iv dosing of 2-IB in an acute peripheral hypoxic ischemia model in healthy subjects did not reveal any notable effects of 2-IB, noting that this model was not selected to guide efficacy in the currently pursued indication of cerebral hypoxia-ischemia.",2020,"2-IB proved to be a high-clearance drug with volume of distribution slightly exceeding total body water volume, and with linear PK that appeared not be affected by presence of Captisol®.","['Healthy Subjects', '2 groups of 9 healthy male subjects', 'healthy subjects', 'healthy male subjects']","['placebo', '2-IB 0.6 mg/kg or placebo', 'Sulfobutylether-beta-cyclodextrin (SBECD', 'intravenously infused with or without Captisol® as solubilizing agent']","['safety, tolerability, pharmacokinetics (PK) and -dynamics', 'Safety, Tolerability, Pharmacokinetics', 'safe and well tolerated']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4068883', 'cui_str': 'Zero point six'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0053407', 'cui_str': 'betadex'}, {'cui': 'C4707055', 'cui_str': 'Infuse'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}]",,0.146719,"2-IB proved to be a high-clearance drug with volume of distribution slightly exceeding total body water volume, and with linear PK that appeared not be affected by presence of Captisol®.","[{'ForeName': 'Ewoud-Jan', 'Initials': 'EJ', 'LastName': 'van Hoogdalem', 'Affiliation': 'Scientific Affairs - Clinical Pharmacology, PRA Health Sciences, Groningen, Netherlands.'}, {'ForeName': 'Cacha M P C D', 'Initials': 'CMPCD', 'LastName': 'Peeters-Scholte', 'Affiliation': ""Neurophyxia B.V., 's-Hertogenbosch, Netherlands.""}, {'ForeName': 'Paul W T J', 'Initials': 'PWTJ', 'LastName': 'Leufkens', 'Affiliation': ""Neurophyxia B.V., 's-Hertogenbosch, Netherlands.""}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Hartstra', 'Affiliation': 'Early Development Services, PRA Health Sciences, Groningen, Netherlands.'}, {'ForeName': 'Jan J', 'Initials': 'JJ', 'LastName': 'van Lier', 'Affiliation': 'Early Development Services, PRA Health Sciences, Groningen, Netherlands.'}, {'ForeName': 'Leo G J', 'Initials': 'LGJ', 'LastName': 'de Leede', 'Affiliation': ""Neurophyxia B.V., 's-Hertogenbosch, Netherlands.""}]",Current clinical pharmacology,['10.2174/1574884714666191017111109']
832,29373284,Erythropoietin to Enhance Recovery of Erectile Function in Men Following Radical Prostatectomy: The ERECT Trial.,"Erythropoietin receptors have been localized to human penile tissue and periprostatic neurovascular bundles. ERECT is a placebo-controlled, phase 2, randomized trial assessing the effect of erythropoietin on recovery of erectile function for men undergoing radical prostatectomy for prostate cancer.",2019,"ERECT is a placebo-controlled, phase 2, randomized trial assessing the effect of erythropoietin on recovery of erectile function for men undergoing radical prostatectomy for prostate cancer.","['Men Following Radical Prostatectomy', 'men undergoing radical prostatectomy for prostate cancer']","['Erythropoietin', 'erythropoietin']",['Erectile Function'],"[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy (procedure)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}]","[{'cui': 'C0014822', 'cui_str': 'Erythropoietin'}]","[{'cui': 'C0031843', 'cui_str': 'function'}]",,0.034009,"ERECT is a placebo-controlled, phase 2, randomized trial assessing the effect of erythropoietin on recovery of erectile function for men undergoing radical prostatectomy for prostate cancer.","[{'ForeName': 'Hiten D', 'Initials': 'HD', 'LastName': 'Patel', 'Affiliation': 'The James Buchanan Brady Urological Institute and Department of Urology, Johns Hopkins University School of Medicine, Baltimore, MD, USA. Electronic address: hitenpatel@jhmi.edu.'}, {'ForeName': 'Mohamad E', 'Initials': 'ME', 'LastName': 'Allaf', 'Affiliation': 'The James Buchanan Brady Urological Institute and Department of Urology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}]",European urology focus,['10.1016/j.euf.2018.01.002']
833,31618099,Entitled Due to Deprivation vs. Superiority: Evidence That Unidimensional Entitlement Scales Blend Distinct Entitlement Rationales across Psychological Dimensions.,"We aimed to corroborate the notion that the Psychological Entitlement Scale (PES), a popular unidimensional index of psychological entitlement, resembles a blend of vulnerable- and grandiose-based entitlement rationales across various psychological dimensions. College participants ( N  = 523) were randomly assigned to complete either the PES or a recently validated, multidimensional adaptation of the PES that purports to assess entitlement due to deprivation (vulnerable-based entitlement; ""PES-V"") and superiority (grandiose-based entitlement; ""PES-G"") claims. Participants then completed a battery of psychological dimensions including: narcissism constructs, interpersonal vulnerability and mood pathology, psychological health, normal personality and personality-disorder traits, motivation systems, a deprived identity, and status aspiration. Profile-similarity indices indicated that PES was more similar to PES-G than PES-V across psychological dimensions. Likewise, additional analyses revealed that indicators of ""narcissistic entitlement"" exhibited stronger profile similarity to PES-G than PES-V across psychological dimensions. In conclusion, profiles of the PES and narcissistic entitlement appear to blend grandiose- and vulnerable-based entitlement, but grandiose-based (vs. vulnerable-based) entitlement seems more prominent in the blend. As a result, unidimensional measures can create a somewhat misleading portrait of the psychologically entitled.",2020,Profile-similarity indices indicated that PES was more similar to PES-G than PES-V across psychological dimensions.,['College participants ( N \u2009=\u2009523'],"['PES or a recently validated, multidimensional adaptation of the PES that purports to assess entitlement due to deprivation (vulnerable-based entitlement; ""PES-V"") and superiority (grandiose-based entitlement; ""PES-G"") claims']","['Psychological Entitlement Scale (PES', 'narcissism constructs, interpersonal vulnerability and mood pathology, psychological health, normal personality and personality-disorder traits, motivation systems, a deprived identity, and status aspiration']","[{'cui': 'C0557806', 'cui_str': 'College (environment)'}]","[{'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0392673', 'cui_str': 'Adaptation, function (observable entity)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0027401', 'cui_str': 'Narcissism'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0031208', 'cui_str': 'Personality'}, {'cui': 'C0031212', 'cui_str': 'Personality Disorders'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0349707', 'cui_str': 'Aspiration - action (qualifier value)'}]",523.0,0.02893,Profile-similarity indices indicated that PES was more similar to PES-G than PES-V across psychological dimensions.,"[{'ForeName': 'William', 'Initials': 'W', 'LastName': 'Hart', 'Affiliation': 'Department of Psychology, University of Alabama, Tuscaloosa, Alabama, USA.'}, {'ForeName': 'Gregory K', 'Initials': 'GK', 'LastName': 'Tortoriello', 'Affiliation': 'Department of Psychology, University of Alabama, Tuscaloosa, Alabama, USA.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Breeden', 'Affiliation': 'Department of Psychology, University of Alabama, Tuscaloosa, Alabama, USA.'}]",Journal of personality assessment,['10.1080/00223891.2019.1674319']
834,29396246,"Mycophenolate plus methylprednisolone versus methylprednisolone alone in active, moderate-to-severe Graves' orbitopathy (MINGO): a randomised, observer-masked, multicentre trial.","BACKGROUND


European guidelines recommend intravenous methylprednisolone as first-line treatment for active and severe Graves' orbitopathy; however, it is common for patients to have no response or have relapse after discontinuation of treatment. We aimed to compare the efficacy and safety of add-on mycophenolate to methylprednisolone in comparison with methylprednisolone alone in patients with moderate-to-severe Graves' orbitopathy.
METHODS


MINGO was an observer-masked, multicentre, block-randomised, centre-stratified trial done in two centres in Germany and two in Italy. Patients with active moderate-to-severe Graves' orbitopathy were randomly assigned to receive intravenous methylprednisolone (500 mg once per week for 6 weeks followed by 250 mg per week for 6 weeks) either alone or with mycophenolate (one 360 mg tablet twice per day for 24 weeks). The prespecified primary endpoints were rate of response (reduction of at least two parameters of a composite ophthalmic index [eyelid swelling, clinical activity score, proptosis, lid width, diplopia, and eye muscle motility] without deterioration in any other parameter) at 12 weeks and rate of relapse (a worsening of symptoms that occurred after a response) at 24 and 36 weeks. Rates of response at week 24 and sustained response at week 36 were added as post-hoc outcomes. Prespecified primary outcomes and post-hoc outcomes were assessed in the modified intention-to-treat population (defined as all patients assigned to treatment who received at least one infusion of methylprednisolone, when outcome data were available), and safety was assessed in all patients who received at least one dose of study drug. This trial is registered with the EU Clinical Trials Register, EUDRACT number 2008-002123-93.
FINDINGS


164 patients were enrolled and randomised between Nov 29, 2009, and July 31, 2015. 81 were randomly assigned to receive methylprednisolone alone and 83 to receive methylprednisolone with mycophenolate. In the intention-to-treat population at 12 weeks, responses were observed in 36 (49%) of 73 patients in the monotherapy group and 48 (63%) of 76 patients in the combination group, giving an odds ratio (OR) of 1·76 (95% CI 0·92-3·39, p=0·089). At week 24, 38 (53%) of 72 patients remaining in the monotherapy group and 53 (71%) of 75 patients remaining in the combination therapy group had responded to treatment (2·16, 1·09-4·25, p=0·026). At week 24, relapse occurred in four (11%) of 38 patients in the monotherapy group and four (8%) of 53 patients in the combination group (OR 0·71, 0·17-3·03, p=0·72). At week 36, relapse occurred in an additional three (8%) patients in the monotherapy group and two (4%) patients in the combination group (0·65, 0·12-3·44, p=0·61). At week 36, 31 (46%) of 68 patients in the monotherapy group and 49 (67%) of 73 patients in the combination group had a sustained response (OR 2·44, 1·23-4·82, p=0·011). 23 patients had 24 serious adverse events, with 11 events in ten patients in the combination group and 13 events in 13 patients in the monotherapy group. Mild and moderate (grade 1-2) drug-related adverse events occurred in 16 (20%) of 81 patients receiving monotherapy and 21 (25%) of 83 patients receiving combination therapy (p=0·48).
INTERPRETATION


Although no significant difference was seen in the rate of response at 12 weeks or rate of relapse at 24 and 36 weeks, post-hoc analysis suggested that addition of mycophenolate to treatment with methylprednisolone improved rate of response to therapy by 24 weeks in patients with active and moderate-to-severe Graves' orbitopathy.
FUNDING


Novartis, Germany.",2018,"Although no significant difference was seen in the rate of response at 12 weeks or rate of relapse at 24 and 36 weeks, post-hoc analysis suggested that addition of mycophenolate to treatment with methylprednisolone improved rate of response to therapy by 24 weeks in patients with active and moderate-to-severe Graves' orbitopathy.
","[""patients with moderate-to-severe Graves' orbitopathy"", '164 patients were enrolled and randomised between Nov 29, 2009, and July 31, 2015', '83 patients receiving combination therapy (p=0·48', 'MINGO was an observer-masked, multicentre, block-randomised, centre-stratified trial done in two centres in Germany and two in Italy', ""Patients with active moderate-to-severe Graves' orbitopathy"", '23 patients had 24']","['methylprednisolone', 'mycophenolate', 'Mycophenolate plus methylprednisolone', 'intravenous methylprednisolone', 'methylprednisolone alone', 'mycophenolate to methylprednisolone', 'methylprednisolone with mycophenolate']","['rate of response to therapy', 'modified intention-to-treat population', 'relapse', 'rate of response', 'efficacy and safety', 'Mild and moderate (grade 1-2) drug-related adverse events', 'serious adverse events', 'rate of response (reduction of at least two parameters of a composite ophthalmic index [eyelid swelling, clinical activity score, proptosis, lid width, diplopia, and eye muscle motility] without deterioration in any other parameter) at 12 weeks and rate of relapse', 'sustained response']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}, {'cui': 'C0024861', 'cui_str': 'Masks'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}]","[{'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0883242', 'cui_str': 'MYCOPHENOLATE'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0015426', 'cui_str': 'Eyelids'}, {'cui': 'C0038999', 'cui_str': 'Bulging (morphologic abnormality)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0015300', 'cui_str': 'Proptosis'}, {'cui': 'C0487742', 'cui_str': 'Width (qualifier value)'}, {'cui': 'C0012569', 'cui_str': 'Double Vision'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C1510470', 'cui_str': 'Motility (observable entity)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]",164.0,0.272052,"Although no significant difference was seen in the rate of response at 12 weeks or rate of relapse at 24 and 36 weeks, post-hoc analysis suggested that addition of mycophenolate to treatment with methylprednisolone improved rate of response to therapy by 24 weeks in patients with active and moderate-to-severe Graves' orbitopathy.
","[{'ForeName': 'George J', 'Initials': 'GJ', 'LastName': 'Kahaly', 'Affiliation': 'Department of Medicine I, Johannes Gutenberg University Medical Center, Mainz, Germany. Electronic address: kahaly@ukmainz.de.'}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Riedl', 'Affiliation': 'Department of Medicine I, Johannes Gutenberg University Medical Center, Mainz, Germany.'}, {'ForeName': 'Jochem', 'Initials': 'J', 'LastName': 'König', 'Affiliation': 'Institute of Medical Biostatistics, Epidemiology and Informatics, Johannes Gutenberg University Medical Center, Mainz, Germany.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Pitz', 'Affiliation': 'Department of Ophthalmology, Johannes Gutenberg University Medical Center, Mainz, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Ponto', 'Affiliation': 'Department of Ophthalmology, Johannes Gutenberg University Medical Center, Mainz, Germany.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Diana', 'Affiliation': 'Department of Medicine I, Johannes Gutenberg University Medical Center, Mainz, Germany.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Kampmann', 'Affiliation': 'Department of Medicine I, Johannes Gutenberg University Medical Center, Mainz, Germany.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Kolbe', 'Affiliation': 'Department of Medicine I, Johannes Gutenberg University Medical Center, Mainz, Germany.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Eckstein', 'Affiliation': 'Department of Ophthalmology, Essen University, Germany.'}, {'ForeName': 'Lars C', 'Initials': 'LC', 'LastName': 'Moeller', 'Affiliation': 'Department of Medicine, Essen University, Germany.'}, {'ForeName': 'Dagmar', 'Initials': 'D', 'LastName': 'Führer', 'Affiliation': 'Department of Medicine, Essen University, Germany.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Salvi', 'Affiliation': 'Department of Endocrinology, University of Milan, Milan, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Curro', 'Affiliation': 'Department of Ophthalmology, Fondazione Cà Granda IRCCS, University of Milan, Milan, Italy.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Campi', 'Affiliation': 'Department of Endocrinology, University of Milan, Milan, Italy.'}, {'ForeName': 'Danila', 'Initials': 'D', 'LastName': 'Covelli', 'Affiliation': 'Department of Endocrinology, University of Milan, Milan, Italy.'}, {'ForeName': 'Marenza', 'Initials': 'M', 'LastName': 'Leo', 'Affiliation': 'Department of Clinical and Experimental Medicine, Endocrinology Unit, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Marinò', 'Affiliation': 'Department of Clinical and Experimental Medicine, Endocrinology Unit, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Menconi', 'Affiliation': 'Department of Clinical and Experimental Medicine, Endocrinology Unit, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Marcocci', 'Affiliation': 'Department of Clinical and Experimental Medicine, Endocrinology Unit, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Bartalena', 'Affiliation': 'Endocrine Unit, University of Insubria, Varese, Italy.'}, {'ForeName': 'Petros', 'Initials': 'P', 'LastName': 'Perros', 'Affiliation': 'Department of Endocrinology, Newcastle University, Newcastle, UK.'}, {'ForeName': 'Wilmar M', 'Initials': 'WM', 'LastName': 'Wiersinga', 'Affiliation': 'Department of Endocrinology and Metabolism, Academic Medical Center, Amsterdam, Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(18)30020-2']
835,31615291,"Risk factors and clinical outcomes in chronic coronary and peripheral artery disease: An analysis of the randomized, double-blind COMPASS trial.","AIMS


Secondary prevention in patients with coronary artery disease and peripheral artery disease involves antithrombotic therapy and optimal control of cardiovascular risk factors. In the Cardiovascular Outcomes for People Using Anticoagulation Strategies (COMPASS) study, adding low-dose rivaroxaban on top of aspirin lowered cardiovascular events, but there is limited data about risk factor control in secondary prevention. We studied the association between risk factor status and outcomes, and the impact of risk factor status on the treatment effect of rivaroxaban, in a large contemporary population of patients with coronary artery disease or peripheral artery disease.
METHODS AND RESULTS


We reported ischemic events (cardiovascular death, stroke, or myocardial infarction) in participants from the randomized, double-blind COMPASS study by individual risk factor (blood pressure, smoking status, cholesterol level, presence of diabetes, body mass index, and level of physical activity), and by number of risk factors. We compared rates and hazard ratios of patients treated with rivaroxaban plus aspirin vs aspirin alone within each risk factor category and tested for interaction between risk factor status and antithrombotic regimen. Complete baseline risk factor status was available in 27,117 (99%) patients. Status and number of risk factors were both associated with increased risk of ischemic events. Rates of ischemic events (hazard ratio 2.2; 95% confidence interval 1.8-2.6) and cardiovascular death (hazard ratio 2.0; 1.5-2.7) were more than twofold higher in patients with 4-6 compared with 0-1 risk factors ( p  < 0.0001 for both). Rivaroxaban reduced event rates independently of the number of risk factors ( p  interaction 0.93), with the largest absolute benefit in patients with the highest number of risk factors.
CONCLUSION


More favorable risk factor status and low-dose rivaroxaban were independently associated with lower risk of cardiovascular events.",2020,Rates of ischemic events (hazard ratio 2.2; 95% confidence interval 1.8-2.6) and cardiovascular death (hazard ratio 2.0; 1.5-2.7) were more than twofold higher in patients with 4-6 compared with 0-1 risk factors ( p  < 0.0001 for both).,"['patients with coronary artery disease or peripheral artery disease', 'chronic coronary and peripheral artery disease', 'patients with coronary artery disease and peripheral artery disease involves antithrombotic therapy and optimal control of cardiovascular risk factors']","['Rivaroxaban', 'rivaroxaban', 'rivaroxaban plus aspirin vs aspirin']","['individual risk factor (blood pressure, smoking status, cholesterol level, presence of diabetes, body mass index, and level of physical activity', 'lower risk of cardiovascular events', 'rates and hazard ratios', 'risk of ischemic events', 'Complete baseline risk factor status', 'Rates of ischemic events', 'ischemic events (cardiovascular death, stroke, or myocardial infarction', 'cardiovascular events', 'cardiovascular death']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Artery Disease'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]","[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}]","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0428466', 'cui_str': 'Finding of cholesterol level (finding)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}]",,0.156801,Rates of ischemic events (hazard ratio 2.2; 95% confidence interval 1.8-2.6) and cardiovascular death (hazard ratio 2.0; 1.5-2.7) were more than twofold higher in patients with 4-6 compared with 0-1 risk factors ( p  < 0.0001 for both).,"[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Vanassche', 'Affiliation': 'Department of Cardiovascular Sciences, University Hospitals Leuven, Belgium.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Verhamme', 'Affiliation': 'Department of Cardiovascular Sciences, University Hospitals Leuven, Belgium.'}, {'ForeName': 'Sonia S', 'Initials': 'SS', 'LastName': 'Anand', 'Affiliation': 'Population Health Research Institute, McMaster University and Hamilton Health Sciences, Canada.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Shestakovska', 'Affiliation': 'Population Health Research Institute, McMaster University and Hamilton Health Sciences, Canada.'}, {'ForeName': 'Keith Aa', 'Initials': 'KA', 'LastName': 'Fox', 'Affiliation': 'Centre for Cardiovascular Science, University of Edinburgh, UK.'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Brigham and Women's Hospital Heart and Vascular Center, Harvard Medical School, USA.""}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Avezum', 'Affiliation': 'Instituto Dante Pazzanese de Cardiologia, Brazil.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Alings', 'Affiliation': 'Amphia Ziekenhuis and Werkgroep Cardiologische Centra Nederland, the Netherlands.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Aboyans', 'Affiliation': 'Department of Cardiology, Dupuytren University Hospital, France.'}, {'ForeName': 'Aldo P', 'Initials': 'AP', 'LastName': 'Maggioni', 'Affiliation': 'Associazione Nazionale Medici Cardiologi Ospedalieri Research Center, Italy.'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Widimsky', 'Affiliation': 'Cardiocenter, Charles University and University Hospital Kralovske Vinohrady, Czech Republic.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Berkowitz', 'Affiliation': 'Research & Development Pharmaceuticals, Bayer U.S. LLC, USA.'}, {'ForeName': 'Salim', 'Initials': 'S', 'LastName': 'Yusuf', 'Affiliation': 'Population Health Research Institute, McMaster University and Hamilton Health Sciences, Canada.'}, {'ForeName': 'Stuart J', 'Initials': 'SJ', 'LastName': 'Connolly', 'Affiliation': 'Population Health Research Institute, McMaster University and Hamilton Health Sciences, Canada.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Eikelboom', 'Affiliation': 'Population Health Research Institute, McMaster University and Hamilton Health Sciences, Canada.'}, {'ForeName': 'Jackie', 'Initials': 'J', 'LastName': 'Bosch', 'Affiliation': 'Population Health Research Institute, McMaster University and Hamilton Health Sciences, Canada.'}]",European journal of preventive cardiology,['10.1177/2047487319882154']
836,31626571,Long-Term Follow-Up of Patients With Nodular Lymphocyte-Predominant Hodgkin Lymphoma Treated in the HD7 to HD15 Trials: A Report From the German Hodgkin Study Group.,"PURPOSE


The optimal treatment of newly diagnosed nodular lymphocyte-predominant Hodgkin lymphoma (NLPHL) is ill defined. We therefore conducted a retrospective analysis using the database of the German Hodgkin Study Group (GHSG).
PATIENTS AND METHODS


The long-term course of 471 patients with NLPHL (early stages, n = 251; intermediate stages, n = 76; advanced stages, n = 144) who had received stage-adapted first-line treatment in the randomized GHSG HD7 to HD15 studies was investigated. Treatment consisted of radiotherapy alone, chemotherapy alone, or combined-modality approaches.
RESULTS


The median age at NLPHL diagnosis was 39 years (range, 16 to 75 years). Patients were mostly male (75.8%). The median observation time was 9.2 years. At 10 years, progression-free survival and overall survival estimates were 75.5% and 92.1% (early stages, 79.7% and 93.3%; intermediate stages, 72.1% and 96.2%; advanced stages, 69.8% and 87.4%), respectively. A total of 48 patients (10.2%) developed a second malignancy during follow-up (non-Hodgkin lymphoma, n = 13; leukemia, n = 6; solid tumor, n = 25; unspecified malignancy, n = 4). Death occurred in 43 patients (9.1%). However, only a minority of deaths were NLPHL related (n = 10), whereas second malignancies (n = 20) and nonmalignant conditions possibly associated with radiotherapy or chemotherapy (n = 13) caused the death in the majority of patients.
CONCLUSION


The overall outcome of patients with NLPHL who had received Hodgkin lymphoma-directed first-line treatment in randomized GHSG trial protocols was good. Nonetheless, treatment optimization is still necessary to reduce toxicity in standard-risk patients and to improve the prognosis in high-risk patients.",2020,"At 10 years, progression-free survival and overall survival estimates were 75.5% and 92.1% (early stages, 79.7% and 93.3%; intermediate stages, 72.1% and 96.2%; advanced stages, 69.8% and 87.4%), respectively.","['newly diagnosed nodular lymphocyte-predominant Hodgkin lymphoma (NLPHL', '48 patients (10.2%) developed a second malignancy during follow-up (non-Hodgkin lymphoma, n = 13; leukemia, n = 6; solid tumor, n = 25; unspecified malignancy, n = 4', 'Patients With Nodular Lymphocyte-Predominant Hodgkin Lymphoma', '471 patients with NLPHL (early stages, n = 251; intermediate stages, n = 76; advanced stages, n = 144) who had received stage-adapted first-line treatment in the randomized GHSG HD7 to HD15 studies was investigated', 'patients with NLPHL who had received Hodgkin lymphoma-directed first-line treatment']","['radiotherapy or chemotherapy', 'radiotherapy alone, chemotherapy alone, or combined-modality approaches']","['median observation time', 'death', 'progression-free survival and overall survival estimates', 'Death', 'toxicity']","[{'cui': 'C1334968', 'cui_str': ""Nodular Sclerosing Hodgkin's Lymphoma""}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085183', 'cui_str': 'Neoplasms, Metachronous Second Primary'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0024305', 'cui_str': ""Lymphoma, Nonhodgkin's""}, {'cui': 'C0023418', 'cui_str': 'Leucocythaemia'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C0205370', 'cui_str': 'Non-specific (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0761050', 'cui_str': '(GVGVP)251'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1708063', 'cui_str': 'First line treatment'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1292732', 'cui_str': 'Investigates'}, {'cui': 'C1266193', 'cui_str': 'Hodgkin lymphoma - category (morphologic abnormality)'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}]","[{'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",471.0,0.0319131,"At 10 years, progression-free survival and overall survival estimates were 75.5% and 92.1% (early stages, 79.7% and 93.3%; intermediate stages, 72.1% and 96.2%; advanced stages, 69.8% and 87.4%), respectively.","[{'ForeName': 'Dennis A', 'Initials': 'DA', 'LastName': 'Eichenauer', 'Affiliation': 'University of Cologne and Center for Integrated Oncology Aachen Bonn Dusseldorf, Cologne, Germany.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Plütschow', 'Affiliation': 'University of Cologne and Center for Integrated Oncology Aachen Bonn Dusseldorf, Cologne, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Fuchs', 'Affiliation': 'University of Cologne and Center for Integrated Oncology Aachen Bonn Dusseldorf, Cologne, Germany.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Sasse', 'Affiliation': 'University of Cologne and Center for Integrated Oncology Aachen Bonn Dusseldorf, Cologne, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Baues', 'Affiliation': 'University of Cologne and Center for Integrated Oncology Aachen Bonn Dusseldorf, Cologne, Germany.'}, {'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Böll', 'Affiliation': 'University of Cologne and Center for Integrated Oncology Aachen Bonn Dusseldorf, Cologne, Germany.'}, {'ForeName': 'Bastian', 'Initials': 'B', 'LastName': 'von Tresckow', 'Affiliation': 'University of Cologne and Center for Integrated Oncology Aachen Bonn Dusseldorf, Cologne, Germany.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Diehl', 'Affiliation': 'German Hodgkin Study Group and University Hospital Cologne, Cologne, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Borchmann', 'Affiliation': 'University of Cologne and Center for Integrated Oncology Aachen Bonn Dusseldorf, Cologne, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Engert', 'Affiliation': 'University of Cologne and Center for Integrated Oncology Aachen Bonn Dusseldorf, Cologne, Germany.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.00986']
837,31621186,Efficacy of the Diabeloop closed-loop system to improve glycaemic control in patients with type 1 diabetes exposed to gastronomic dinners or to sustained physical exercise.,"AIMS


To compare closed-loop (CL) and open-loop (OL) systems for glycaemic control in patients with type 1 diabetes (T1D) exposed to real-life challenging situations (gastronomic dinners or sustained physical exercise).
METHODS


Thirty-eight adult patients with T1D were included in a three-armed randomized pilot trial (Diabeloop WP6.2 trial) comparing glucose control using a CL system with use of an OL device during two crossover 72-hour periods in one of the three following situations: large (gastronomic) dinners; sustained and repeated bouts of physical exercise (with uncontrolled food intake); or control (rest conditions). Outcomes included time in spent in the glucose ranges of 4.4-7.8 mmol/L and 3.9-10.0 mmol/L, and time in hypo- and hyperglycaemia.
RESULTS


Time spent overnight in the tight range of 4.4 to 7.8 mmol/L was longer with CL (mean values: 63.2% vs 40.9% with OL; P ≤ .0001). Time spent during the day in the range of 3.9 to 10.0 mmol/L was also longer with CL (79.4% vs 64.1% with OL; P ≤ .0001). Participants using the CL system spent less time during the day with hyperglycaemic excursions (glucose >10.0 mmol/L) compared to those using an OL system (17.9% vs 31.9%; P ≤ .0001), and the proportions of time spent during the day with hyperglycaemic excursions of those using the CL system in the gastronomic dinner and physical exercise subgroups were of similar magnitude to those in the control subgroup (18.1 ± 6.3%, 17.2 ± 8.1% and 18.4 ± 12.5%, respectively). Finally, times spent in hypoglycaemia were short and not significantly different among the groups.
CONCLUSIONS


The Diabeloop CL system is superior to OL devices in reducing hyperglycaemic excursions in patients with T1D exposed to gastronomic dinners, or exposed to physical exercise followed by uncontrolled food and carbohydrate intake.",2020,"Participants using CL spent shorter day-time in hyperglycaemic excursions (glucose >180 mg/dL) compared to those using OL (17.9% versus 31.9%, P ≤0.0001), and their day-time spent in hyperglycaemic excursions in the copious dinner and physical exercise subgroups were of similar magnitude as those in the control subgroup (18.1±6.3%, 17.2±8.1% and 18.4±12.5%, respectively).","['Thirty-eight adult patients with T1D', 'patients with type 1 diabetes (T1D) exposed to real life challenging situations (copious dinners or sustained physical exercise', 'patients with type 1 diabetes exposed to copious dinners or to sustained physical exercise']","['Diabeloop closed-loop (CL) and open-loop (OL', 'Diabeloop closed-loop', 'copious (gastronomic) dinners, sustained and repeated bouts of physical exercise (with uncontrolled food intake) or control (rest conditions', 'glucose control with CL or OL']","['time in hypo- and hyperglycaemia', 'time-in-ranges (TIRs', 'times in hypoglycaemia', 'CL spent shorter day-time in hyperglycaemic excursions', 'hyperglycaemic excursions', 'glycaemic control']","[{'cui': 'C0450361', 'cui_str': '38 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C4552592', 'cui_str': 'With dinner'}, {'cui': 'C0443318', 'cui_str': 'Sustained (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0587267', 'cui_str': 'Closed (qualifier value)'}, {'cui': 'C0445022', 'cui_str': 'Loop (qualifier value)'}, {'cui': 'C0559530', 'cui_str': 'Open loop (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0443183', 'cui_str': 'Closed loop (qualifier value)'}, {'cui': 'C4552592', 'cui_str': 'With dinner'}, {'cui': 'C0443318', 'cui_str': 'Sustained (qualifier value)'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",38.0,0.0555712,"Participants using CL spent shorter day-time in hyperglycaemic excursions (glucose >180 mg/dL) compared to those using OL (17.9% versus 31.9%, P ≤0.0001), and their day-time spent in hyperglycaemic excursions in the copious dinner and physical exercise subgroups were of similar magnitude as those in the control subgroup (18.1±6.3%, 17.2±8.1% and 18.4±12.5%, respectively).","[{'ForeName': 'Hélène', 'Initials': 'H', 'LastName': 'Hanaire', 'Affiliation': 'Department of Diabetology, Metabolic Diseases and Nutrition, CHU Toulouse, University of Toulouse, Toulouse, France.'}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Franc', 'Affiliation': ""Department of Diabetes, Sud-Francilien Hospital, Corbeil-Essonnes, and Centre d'Etude et de Recherche pour l'Intensification du Traitement du Diabete, Evry, France.""}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Borot', 'Affiliation': 'Department of Endocrinology, Metabolism, Diabetes and Nutrition, Centre Hospitalier Universitaire Jean Minjoz, Besançon, France.'}, {'ForeName': 'Alfred', 'Initials': 'A', 'LastName': 'Penfornis', 'Affiliation': ""Department of Diabetes, Sud-Francilien Hospital, Corbeil-Essonnes, and Centre d'Etude et de Recherche pour l'Intensification du Traitement du Diabete, Evry, France.""}, {'ForeName': 'Pierre-Yves', 'Initials': 'PY', 'LastName': 'Benhamou', 'Affiliation': 'Department of Diabetology, Pôle DigiDune, University Hospital, Grenoble, France.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Schaepelynck', 'Affiliation': 'Department of Nutrition-Endocrinology-Metabolic Disorders, Marseille University Hospital, Sainte Marguerite Hospital, Marseille, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Renard', 'Affiliation': 'Department of Endocrinology, Diabetes and Nutrition, Montpellier University Hospital, and Institute of Functional Genomics, CNRS, INSERM, University of Montpellier, Montpellier, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Guerci', 'Affiliation': 'Endocrinology-Diabetes Care Unit, University of Lorraine, Vandoeuvre Lès Nancy, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Jeandidier', 'Affiliation': 'Department of Endocrinology, Diabetes and Nutrition, CHU of Strasbourg, Strasbourg, France.'}, {'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'Simon', 'Affiliation': 'Department of Endocrinology, Diabetes and Nutrition, Centre Hospitalier Lyon Sud, Lyon, France.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Hannaert', 'Affiliation': 'School of Medicine and Pharmacy of Poitiers, IRTOMIT, INSERM UMR 1082, Poitiers, France.'}, {'ForeName': 'Ilham', 'Initials': 'I', 'LastName': 'Xhaard', 'Affiliation': ""Centre d'Etudes et de Recherches pour l'Intensification du Traitement du Diabète, Evry, France.""}, {'ForeName': 'Maeva', 'Initials': 'M', 'LastName': 'Doron', 'Affiliation': 'University Grenoble Alpes, Grenoble, France.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Huneker', 'Affiliation': 'DIABELOOP S.A., Paris, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Charpentier', 'Affiliation': ""Department of Diabetes, Sud-Francilien Hospital, Corbeil-Essonnes, and Centre d'Etude et de Recherche pour l'Intensification du Traitement du Diabete, Evry, France.""}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Reznik', 'Affiliation': 'Department of Endocrinology, University of Caen Côte de Nacre Regional Hospital Centre, Caen, France.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13898']
838,31609865,Dose Escalation of Naltrexone to Reduce Stress Responses Associated With Opioid Antagonist Induction: A Double-blind Randomized Trial.,"CONTEXT


To describe the role of opioid antagonist induction in reducing stress response and withdrawal symptoms.
OBJECTIVE


Complexity of naltrexone induction is limiting broader applicability of opioid antagonist-assisted abstinence. The aim of this clinical trial was to assess the stress response to 2 low-dose naltrexone induction protocols under minimal oral sedation.
DESIGN


Double-blind randomized controlled trial.
SETTING


Open setting in-patient unit.
PARTICIPANTS


Adults with opioid use disorder, and at least a year-long history of opioid use.
INTERVENTION PROTOCOL


Patients received either a single 12.5 mg naltrexone oral dose (SI group) or escalating dosage regimen starting from 50 μg up to a cumulative dose of 12.5 mg (ED group).
MAIN OUTCOME MEASURE


Differences in cortisol and adrenocorticotropic hormone (ACTH) concentrations 1 hour after the start of naltrexone induction.
RESULTS


In all, 124 patients were enrolled and 68 remained in the trial at the point of randomization-33 in SI and 35 in ED group. Eight patients were excluded from final analysis. Plasma cortisol and ACTH concentrations were significantly higher in SI group; mean difference between groups 313 nmol/L (95% confidence interval [CI] 182-444, P < 0.001) and 36.9 pg/mL (95% CI 12.3-61.4, P = 0.004), respectively.
SECONDARY OUTCOMES


SI patients experienced significant increases in plasma cortisol and ACTH concentrations, and withdrawal scores. In ED group these measures remained at or below baseline throughout the 24-hour period from start of naltrexone induction.
CONCLUSIONS


Contrary to a single 12.5-mg dose, the escalating naltrexone dosing regimen produced no significant increase in stress response and withdrawal scores during antagonist induction.",2020,"Plasma cortisol and ACTH concentrations were significantly higher in SI group; mean difference between groups 313 nmol/L (95% confidence interval [CI] 182-444, P < 0.001) and 36.9 pg/mL (95% CI 12.3-61.4, P = 0.004), respectively.
","['124 patients were enrolled and 68 remained in the trial at the point of randomization-33 in SI and 35 in ED group', 'Adults with opioid use disorder, and at least a year-long history of opioid use', 'Eight patients were excluded from final analysis', 'Open setting in-patient unit']","['Naltrexone', 'naltrexone oral dose (SI group) or escalating dosage regimen starting from 50\u200aμg up to a cumulative dose of 12.5\u200amg (ED group', 'naltrexone', 'naltrexone induction protocols', 'Opioid Antagonist Induction']","['stress response and withdrawal scores', 'plasma cortisol and ACTH concentrations, and withdrawal scores', 'stress response', 'Plasma cortisol and ACTH concentrations', 'cortisol and adrenocorticotropic hormone (ACTH) concentrations']","[{'cui': 'C4517553', 'cui_str': '124 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}]","[{'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0178602', 'cui_str': 'Dosages (qualifier value)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C4517544', 'cui_str': '12.5 (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0027410', 'cui_str': 'Opioid Receptor Antagonists'}]","[{'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1281899', 'cui_str': 'Plasma cortisol measurement'}, {'cui': 'C0201835', 'cui_str': 'Adrenocorticotropic hormone measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}]",124.0,0.19885,"Plasma cortisol and ACTH concentrations were significantly higher in SI group; mean difference between groups 313 nmol/L (95% confidence interval [CI] 182-444, P < 0.001) and 36.9 pg/mL (95% CI 12.3-61.4, P = 0.004), respectively.
","[{'ForeName': 'Robertas', 'Initials': 'R', 'LastName': 'Badaras', 'Affiliation': 'Faculty of Medicine, Vilnius University, Lithuania (RB, JI); Clinic of Anesthesiology, Lithuanian University of Health Sciences, Lithuania (TJ); Centre of Toxicology, Vilnius University Emergency Hospital, Lithuania (RB, IL); Department of Critical Care, BHR University Hospitals NHS Trust, UK (TJ).'}, {'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Jovaisa', 'Affiliation': ''}, {'ForeName': 'Indre', 'Initials': 'I', 'LastName': 'Lapinskiene', 'Affiliation': ''}, {'ForeName': 'Juozas', 'Initials': 'J', 'LastName': 'Ivaskevicius', 'Affiliation': ''}]",Journal of addiction medicine,['10.1097/ADM.0000000000000560']
839,29392574,Comparison of the Pharmacokinetics of Droxidopa After Dosing in the Fed Versus Fasted State and with 3-Times-Daily Dosing in Healthy Elderly Subjects.,"BACKGROUND


Droxidopa is an oral prodrug of norepinephrine approved for the treatment of symptomatic neurogenic orthostatic hypotension. This two-part, randomized, crossover study evaluated the 24-h pharmacokinetic profile of droxidopa in 24 healthy elderly subjects.
METHODS


Noncompartmental analysis was used to calculate the area under the plasma concentration-time curve (AUC), maximum plasma concentration (C max ), time of C max  (t max ), and elimination half-life (t ½e ) of droxidopa and metabolites. Droxidopa was administered in the fed (high-fat/high-calorie meal) or fasted state either as a single 300-mg dose (three 100-mg capsules) or 3 times/day (TID) (three 100-mg capsules) at 4-h intervals.
RESULTS


Administration of a single droxidopa dose in the fed versus fasted state decreased mean C max  (2057 vs 3160 ng/mL) and mean AUC (10,927 vs 13,857 h × ng/mL) and increased median t max  twofold (4.00 vs 2.00 h). Differences between the fed and fasted state for mean t ½e  (2.58 vs 2.68 h) were not observed. Fed versus fasted geometric mean ratios for C max  and AUC were 66% [90% confidence interval (CI) 60.7-71.7] and 80% (90% CI 72.6-88.1), respectively. With TID dosing, similar values for C max  were observed after each dose (range 2789-3389 ng/mL) with no return to baseline between doses. Norepinephrine C max  was 895 pg/mL following dose 1, with no further increases upon subsequent doses; norepinephrine levels remained above baseline for 12-16 h after dose 1.
CONCLUSIONS


Absorption of a single dose of droxidopa is slowed after a high-fat/high-calorie meal; for consistent effect, administer droxidopa in the same manner (with or without food). Pharmacokinetic parameters of droxidopa are similar after single and TID dosing. ClinicalTrials.gov Identifier: NCT01149629.",2018,"Norepinephrine C max  was 895 pg/mL following dose 1, with no further increases upon subsequent doses; norepinephrine levels remained above baseline for 12-16 h after dose 1.
","['24 healthy elderly subjects', 'symptomatic neurogenic orthostatic hypotension', 'Healthy Elderly Subjects']","['Norepinephrine C max', 'norepinephrine', 'droxidopa', 'Droxidopa']","['fasted geometric mean ratios for C max  and AUC', 'area under the plasma concentration-time curve (AUC), maximum plasma concentration (C max ), time of C max  (t max ), and elimination half-life (t ½e ) of droxidopa and metabolites', 'subsequent doses; norepinephrine levels', 'mean C max', 'mean AUC ']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0020651', 'cui_str': 'Hypotension, Postural'}]","[{'cui': 'C0202145', 'cui_str': 'Norepinephrine measurement (procedure)'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0000378', 'cui_str': 'Droxidopa'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0018517', 'cui_str': 'Halflife'}, {'cui': 'C0000378', 'cui_str': 'Droxidopa'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0202145', 'cui_str': 'Norepinephrine measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",24.0,0.150962,"Norepinephrine C max  was 895 pg/mL following dose 1, with no further increases upon subsequent doses; norepinephrine levels remained above baseline for 12-16 h after dose 1.
","[{'ForeName': 'Jack J', 'Initials': 'JJ', 'LastName': 'Chen', 'Affiliation': 'Department of Pharmacy Practice, College of Pharmacy, Marshall B. Ketchum University, Fullerton, CA, USA.'}, {'ForeName': 'L Arthur', 'Initials': 'LA', 'LastName': 'Hewitt', 'Affiliation': 'Lundbeck, 6 Parkway North, Deerfield, IL, 60015, USA. lhew@lundbeck.com.'}]",Drugs in R&D,['10.1007/s40268-018-0226-z']
840,31860360,Detecting Feigning in Adolescents on the Personality Assessment Inventory-Adolescent Form.,"Much of the research on identifying feigning in psychological assessment has focused on adults with less attention to adolescents. The purpose of the present study is to expand the limited literature on detecting feigning in adolescents using the Personality Assessment Inventory - Adolescent. The study included 114 nonclinical adolescents (ages 15 to 18) recruited from high schools in the Midwest who were randomly assigned to experimental groups: honest nonclinical, uncoached feigning, and coached feigning. 50 randomly selected individuals with depression from the PAI-A clinical standardization sample were included as the honest clinical group. Sample demographics included a mean age of 16.64 years; 51.2% young men, 48.2% young women; 85.4% Caucasian, 6.7% African American, 5.5% Hispanic, and 2.4% Asian. 80% of feigning profiles reported clinical levels of depression. MANOVA results showed strong support for the Rogers Discriminant Function (RDF;  d  range = 1.85-2.05). The Negative Impression Management (NIM) scale also demonstrated promise ( d  range = 0.77-1.08), while the smallest effects for detecting feigning were found for the Malingering Index ( d  range = 0.58-0.70). The negative distortion indices showed good utility in differentiating between groups. Cut-scores and pragmatic implications are presented.",2020,"The Negative Impression Management (NIM) scale also demonstrated promise ( d  range = 0.77-1.08), while the smallest effects for detecting feigning were found for the Malingering Index ( d  range = 0.58-0.70).","['adolescents using the Personality Assessment Inventory - Adolescent', 'Sample demographics included a mean age of 16.64\u2009years; 51.2% young men, 48.2% young women; 85.4% Caucasian, 6.7% African American, 5.5% Hispanic, and 2.4% Asian', '50 randomly selected individuals with depression from the PAI-A clinical standardization sample were included as the honest clinical group', 'Adolescents on the Personality Assessment Inventory-Adolescent Form', '114 nonclinical adolescents (ages 15 to 18) recruited from high schools in the Midwest who were randomly assigned to experimental groups', 'adults with less attention to adolescents']","['honest nonclinical, uncoached feigning, and coached feigning']","['Negative Impression Management (NIM) scale', 'clinical levels of depression']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0031209', 'cui_str': 'Personality Assessment'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C4517631', 'cui_str': '2.4 (qualifier value)'}, {'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0038136', 'cui_str': 'Standardization'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C4708785', 'cui_str': 'One hundred and fourteen'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]","[{'cui': 'C0557773', 'cui_str': 'Coach (physical object)'}]","[{'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1319226', 'cui_str': 'Level of depression'}]",50.0,0.0215101,"The Negative Impression Management (NIM) scale also demonstrated promise ( d  range = 0.77-1.08), while the smallest effects for detecting feigning were found for the Malingering Index ( d  range = 0.58-0.70).","[{'ForeName': 'Steven P', 'Initials': 'SP', 'LastName': 'Malm', 'Affiliation': 'Peotone Community Unit School District 207-U, Peotone, IL, USA.'}, {'ForeName': 'Eric E', 'Initials': 'EE', 'LastName': 'Pierson', 'Affiliation': 'Department of Educational Psychology, Ball State University, Muncie, IN, USA.'}, {'ForeName': 'W Holmes', 'Initials': 'WH', 'LastName': 'Finch', 'Affiliation': 'Department of Educational Psychology, Ball State University, Muncie, IN, USA.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Spengler', 'Affiliation': 'Department of Educational Psychology, Ball State University, Muncie, IN, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Johnson', 'Affiliation': 'Department of Educational Psychology, Ball State University, Muncie, IN, USA.'}, {'ForeName': 'Leslie C', 'Initials': 'LC', 'LastName': 'Morey', 'Affiliation': 'Department of Psychological & Brain Sciences, Texas A&M University, College Station, TX, USA.'}]",Journal of personality assessment,['10.1080/00223891.2019.1693389']
841,31625497,"Effects of a Korean version of the metacognitive training program for outpatients with schizophrenia on theory of mind, positive symptoms, and interpersonal relationships.","BACKGROUND


Since the significance of metacognition as the theoretical basis of a psychological intervention for schizophrenia first emerged, there have been ongoing attempts to restore or strengthen patients' metacognitive abilities.
AIM


A Korean version of the metacognitive training (MCT) program was developed, and its effects on theory of mind, positive and negative symptoms, and interpersonal relationships were examined in stable outpatients with schizophrenia.
METHOD


A pre-test-post-test design with a control group was used. The participants were 59 outpatients (30 in experimental group, 29 in control group) registered at five mental health facilities in a city in South Korea. The developed MCT program was applied for a total of 18 sessions, 60 min per session, over a period of 14 weeks. The hinting task, false belief task, Scale for the Assessment of Positive and Negative Symptoms, and Relationship Change Scale were used to verify the effects of this program. Data were analysed by the chi-square test, t-test, and Mann-Whitney U-test using the SPSS/PASW 18.0 statistics program.
RESULTS


The general characteristics, intelligence, and outcome variables of the two groups were homogeneous. After the intervention, the experimental group showed significant improvements in theory of mind, positive and negative symptoms and interpersonal relationships compared with the control group.
CONCLUSION


These results suggest that the MCT program can be a complementary psychotherapy that contributes to symptom relief and interpersonal functioning in patients with schizophrenia, and is effective in the Korean culture, beyond the Western context.",2020,"After the intervention, the experimental group showed significant improvements in theory of mind, positive and negative symptoms and interpersonal relationships compared with the control group.
","['patients with schizophrenia', 'outpatients with schizophrenia on theory of mind, positive symptoms, and interpersonal relationships', 'stable outpatients with schizophrenia', 'participants were 59 outpatients (30 in experimental group, 29 in control group) registered at five mental health facilities in a city in South Korea']","['metacognitive training program', 'metacognitive training (MCT) program', 'MCT program']","['hinting task, false belief task, Scale for the Assessment of Positive and Negative Symptoms, and Relationship Change Scale', 'theory of mind, positive and negative symptoms and interpersonal relationships']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0935573', 'cui_str': 'Mentalizing'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0022773', 'cui_str': 'South Korea'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1173173', 'cui_str': 'N-methanocarbathymidine'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0205237', 'cui_str': 'False (qualifier value)'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0222045'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0935573', 'cui_str': 'Mentalizing'}]",59.0,0.0183551,"After the intervention, the experimental group showed significant improvements in theory of mind, positive and negative symptoms and interpersonal relationships compared with the control group.
","[{'ForeName': 'Sungwon', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': 'Faculty of Department of Nursing, College of Life Science and Nano Technology, Hannam University, Daejeon, South Korea.'}, {'ForeName': 'Hye Kyung', 'Initials': 'HK', 'LastName': 'Lee', 'Affiliation': 'Faculty of Department of Social Welfare, College of Rehabilitation & Welfare & Education, Konyang University, Nonsan, South Korea.'}, {'ForeName': 'Hyunlye', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Faculty of Department of Nursing, College of Medicine, Chosun University, Gwangju, South Korea.'}]",Behavioural and cognitive psychotherapy,['10.1017/S1352465819000560']
842,28531784,"Gut microbiota mediated benefits of barley kernel products on metabolism, gut hormones, and inflammatory markers as affected by co-ingestion of commercially available probiotics: a randomized controlled study in healthy subjects.","BACKGROUND AND AIMS


Barley kernel based products have been shown to induce benefits on blood glucose regulation, cardio-metabolic risk markers and appetite regulating hormones in a time perspective of 11-16 h after intake. The mechanisms have been assigned to gut fermentation of indigestible carbohydrates. The purpose of the present study was to evaluate if the modulatory effects of barley on markers of metabolic- and appetite regulation are affected by a dietary background including a mixture of commercially available probiotics.
METHODS


Barley kernel bread was included in the normal diet of 21 healthy subjects in two 4-day intervention periods; with (BB-pro) or without (BB) dietary supplement with a combination of probiotics (Bifidobacterium animalis DN-173 010, Lactobacillus reuteri DSM 17938, and Lactobacillus plantarum 299v). A white wheat flour based bread was included as a reference product (WWB-ref) in a separate 4-day bread intervention period. A cross-over design was applied concerning BB- and WWB-ref; the BB-pro intervention was last in the test sequence. The BB-pro intervention was preceded by 10 days priming with probiotics. The 4 day BB- and WWB-ref intervention periods included dietary supplementation with placebo, and the interventions were preceded with 10 days priming with the placebo. The day after each intervention period, blood samples were collected at fasting and postprandially after a standardized breakfast (0-210 min) for determination of markers of glucose metabolism (blood glucose, serum (s-) insulin), inflammation (s-IL-6, s-IL-18, s-CRP, PAI-1), and concentrations of gut derived hormones involved in satiety and glucose homeostasis (plasma (p-) PYY, p-GLP-1) and intestinal barrier integrity (p-GLP-2). Breath hydrogen was determined as a marker of colonic fermentation.
RESULTS


Four days intervention with BB, in comparison to WWB-ref, lowered blood glucose response after a subsequent standardized breakfast (0-210 min, P < 0.05). BB and BB-pro interventions increased p-GLP-1 (0-120 min, P < 0.05) and breath H 2  (0-210 min, P < 0.05). BB-pro intervention, in comparison to BB and WWB-ref, increased levels of s-PAI-1 (P < 0.05), and p-GLP-2 (0-210 min, P < 0.05) after the standardized breakfast.
CONCLUSIONS


With the exception of increased p-GLP-2 and an unexpected increase in s-PAI-1 concentrations, co-ingestion of a mixture of probiotics did not affect the metabolic outcome of BB; neither positively nor importantly negatively. The study was registered at: ClinicalTrials.gov, register number NCT01718418 (www.clinicaltrials.gov/ct2/show/NCT01718418).",2016,"BB and BB-pro interventions increased p-GLP-1 (0-120 min, P < 0.05) and breath H 2  (0-210 min, P ","['healthy subjects', 'Barley kernel bread was included in the normal diet of 21 healthy subjects in two']","['4-day intervention periods; with (BB-pro) or without (BB) dietary supplement with a combination of probiotics (Bifidobacterium animalis DN-173 010, Lactobacillus reuteri DSM 17938, and Lactobacillus plantarum 299v', 'placebo']","['glucose metabolism (blood glucose, serum (s-) insulin), inflammation (s-IL-6, s-IL-18, s-CRP, PAI-1), and concentrations of gut derived hormones involved in satiety and glucose homeostasis (plasma (p-) PYY, p-GLP-1) and intestinal barrier integrity (p-GLP-2', 'Breath hydrogen', 'blood glucose response', 'metabolic outcome of BB', 'p-GLP-1', 'levels of s-PAI-1']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0004755', 'cui_str': 'Hordeum'}, {'cui': 'C0006138', 'cui_str': 'Bread'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0184625', 'cui_str': 'Regular diet'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0242295', 'cui_str': 'Dietary Supplementations'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}, {'cui': 'C0317625', 'cui_str': 'Lactobacillus reuteri'}, {'cui': 'C0317608', 'cui_str': 'Lactobacillus plantarum'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0383327', 'cui_str': 'Interferon-gamma-Inducing Factor'}, {'cui': 'C0030190', 'cui_str': 'SERPINE1 Protein'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0036239', 'cui_str': 'Satiations'}, {'cui': 'C0019868', 'cui_str': 'Autoregulation'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0070358', 'cui_str': 'PYY Peptide'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C1947912', 'cui_str': 'Integrity (attribute)'}, {'cui': 'C1530889', 'cui_str': 'teduglutide'}, {'cui': 'C0225386', 'cui_str': 'Breath (substance)'}, {'cui': 'C0020275', 'cui_str': 'Hydrogen'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",21.0,0.108546,"BB and BB-pro interventions increased p-GLP-1 (0-120 min, P < 0.05) and breath H 2  (0-210 min, P ","[{'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Nilsson', 'Affiliation': 'Food for Health Science Centre, Lund University, Lund, Sweden. Electronic address: anne.nilsson@food-health-science.lu.se.'}, {'ForeName': 'Elin', 'Initials': 'E', 'LastName': 'Johansson-Boll', 'Affiliation': 'Food for Health Science Centre, Lund University, Lund, Sweden. Electronic address: elinvekka@gmail.com.'}, {'ForeName': 'Jonna', 'Initials': 'J', 'LastName': 'Sandberg', 'Affiliation': 'Food for Health Science Centre, Lund University, Lund, Sweden. Electronic address: jonna.sandberg@food-health-science.lu.se.'}, {'ForeName': 'Inger', 'Initials': 'I', 'LastName': 'Björck', 'Affiliation': 'Food for Health Science Centre, Lund University, Lund, Sweden. Electronic address: Inger.Bjorck@food-health-science.lu.se.'}]",Clinical nutrition ESPEN,['10.1016/j.clnesp.2016.06.006']
843,31595600,Positive response to galcanezumab following treatment failure to onabotulinumtoxinA in patients with migraine: post hoc analyses of three randomized double-blind studies.,"BACKGROUND AND PURPOSE


Humanized monoclonal antibody galcanezumab, which binds to calcitonin-gene-related peptide, has shown efficacy for episodic and chronic migraine prevention. These analyses evaluated galcanezumab response for migraine headache prevention in patients who previously failed onabotulinumtoxinA ('nonresponse' or 'inadequate response' or safety reasons).
METHODS


Post hoc analyses included data from three double-blind, placebo-controlled, phase 3 episodic or chronic migraine studies; 2886 patients randomly received 120 or 240 mg galcanezumab or placebo. During double-blind periods the study drug was administered subcutaneously once a month for 6 months in EVOLVE-1 and -2 and for 3 months in REGAIN. The 120 mg groups received a 240 mg loading dose at month 1. Pooled analyses included 129 patients who failed onabotulinumtoxinA. Using mixed effect model repeat measurements, the least squares mean change from baseline in the number of migraine headache days (MHDs) was calculated for the first 3 months of treatment.
RESULTS


For pooled analyses, significant decreases from baseline in the number of MHDs were observed for 120 mg (-3.91) and 240 mg (-5.27) galcanezumab overall versus placebo (-0.88) across 3-month time points for patients who failed onabotulinumtoxinA. Corresponding data for patients with chronic migraine showed significant decreases: 120 mg (-3.18) and 240 mg (-4.26) galcanezumab versus placebo (0.16). Significant reductions in the number of MHDs per month with acute medication use included 120 mg galcanezumab (-4.35) and 240 mg galcanezumab (-4.55) versus placebo (-0.83). Estimates of ≥50% response during months 1-3 were 9.4% for placebo, 41.3% for 120 mg galcanezumab and 47.5% for 240 mg galcanezumab.
CONCLUSION


Galcanezumab is an option for prevention of migraine in patients who have previously failed onabotulinumtoxinA preventive therapy.",2020,", significant decreases from baseline in number of MHDs were observed for 120mg (-3.91) and 240mg (-5.27) galcanezumab overall vs placebo (-0.88) across 3-month time points for patients who failed onabotulinumtoxinA. Corresponding data for patients with chronic migraine showed significant decreases: 120mg (-3.18) and 240mg (-4.26) galcanezumab vs placebo (0.16).","['Patients With Migraine', 'patients who previously failed onabotulinumtoxinA (""nonresponse"" or ""inadequate response"" or safety reasons', 'controlled, Phase 3 episodic or chronic migraine studies; 2,886 patients randomly received 120mg or 240mg', 'patients who have previously failed onabotulinumtoxinA preventive therapy', '129 patients who failed onabotulinumtoxinA. Using mixed effect model repeat measurement']","['OnabotulinumtoxinA', 'placebo', 'galcanezumab or placebo', 'galcanezumab vs placebo', 'galcanezumab', 'Galcanezumab']","['number of MHDs', 'migraine headache days (MHDs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C2719767', 'cui_str': 'onabotulinumtoxinA'}, {'cui': 'C0205412', 'cui_str': 'Inadequate (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0684328', 'cui_str': 'Reasoning'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439561', 'cui_str': 'Phase 3 (qualifier value)'}, {'cui': 'C1455761', 'cui_str': 'Episodic (qualifier value)'}, {'cui': 'C1960870', 'cui_str': 'Chronic migraine'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}]","[{'cui': 'C2719767', 'cui_str': 'onabotulinumtoxinA'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",2886.0,0.320147,", significant decreases from baseline in number of MHDs were observed for 120mg (-3.91) and 240mg (-5.27) galcanezumab overall vs placebo (-0.88) across 3-month time points for patients who failed onabotulinumtoxinA. Corresponding data for patients with chronic migraine showed significant decreases: 120mg (-3.18) and 240mg (-4.26) galcanezumab vs placebo (0.16).","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Ailani', 'Affiliation': 'MedStar Georgetown University, Washington, DC, USA.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Pearlman', 'Affiliation': 'Lilly USA, LLC, Indianapolis, IN, USA.'}, {'ForeName': 'Q', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'Nagy', 'Affiliation': 'Nevada Headache Institute, Las Vegas, NV, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Schuh', 'Affiliation': 'Lilly USA, LLC, Indianapolis, IN, USA.'}, {'ForeName': 'S K', 'Initials': 'SK', 'LastName': 'Aurora', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}]",European journal of neurology,['10.1111/ene.14102']
844,31851001,Are Postoperative Intravenous Antibiotics Indicated After Laparoscopic Appendicectomy for Simple Appendicitis? A Prospective Double-blinded Randomized Controlled Trial.,"BACKGROUND


There is limited evidence for the use of postoperative antibiotics for simple appendicitis (SA) in children. Our aim was to conduct a prospective double-blinded randomized controlled trial to investigate this after a laparoscopic appendicectomy.
METHODS


Following ethical approval, children (≤16 years) undergoing appendicectomy were recruited at a single institution. Patients were randomized intraoperatively to receive either 2 postoperative intravenous doses of placebo or antibiotics (Abx). All patients received a dose of Abx at induction of anesthesia. Primary outcome was the incidence of postoperative wound infection (WI), and secondary outcome was the incidence of intra-abdominal abscess formation. Data are reported as number of cases (%), median (range), relative risk, and analyzed using Mann Whitney U test, Chi-square test, as appropriate, a P-value ≤0.05 was considered significant.
RESULTS


A total of 304 patients were randomized. Sixty-one were subsequently excluded due to protocol violations or recruitment errors; therefore, 243 were included in the final analysis. One hundred twenty-two patients received placebo and 121 Intravenous Abx. There was no difference between the sex (50F/72 M vs 47F/74 M, P = 0.8), median age (12.4 vs 12.2 years, P = 0.5), and postoperative length of stay in a hospital (27.2 vs 25.6 hours, P = 0.7). There was also no difference in the preoperative blood results. A total of 9 WIs occurred: 8/122 (6.6%) placebo versus 1/121 (0.8%) Abx, P = 0.01 [relative risk for WI 1.83 (95% confidence interval: 1.145-2.201)]. There were no intra-abdominal abscess in either groups.
CONCLUSIONS


This prospective randomized double blinded randomized controlled trial has revealed a significant decrease in WI rates by giving 2 postoperative intravenous doses of Abx, suggesting postoperative Abx are of benefit in SA.",2019,"There was no difference between the sex (50F/72 M vs 47F/74 M, P = 0.8), median age (12.4 vs 12.2 years, P = 0.5), and postoperative length of stay in a hospital (27.2 vs 25.6 hours, P = 0.7).","['simple appendicitis (SA) in children', '304 patients were randomized', 'One hundred twenty-two patients received', 'Sixty-one were subsequently excluded due to protocol violations or recruitment errors; therefore, 243 were included in the final analysis', 'Following ethical approval, children (≤16 years) undergoing appendicectomy were recruited at a single institution']","['Laparoscopic Appendicectomy', 'placebo or antibiotics (Abx', 'placebo', 'laparoscopic appendicectomy']","['intra-abdominal abscess', 'WI rates', 'postoperative length of stay in a hospital', 'incidence of postoperative wound infection (WI), and secondary outcome was the incidence of intra-abdominal abscess formation']","[{'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4284772', 'cui_str': '22 (qualifier value)'}, {'cui': 'C4517832', 'cui_str': 'Sixty-one'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0003611', 'cui_str': 'Appendectomy'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1272753', 'cui_str': 'Institution'}]","[{'cui': 'C0372525', 'cui_str': 'Endoscopic appendectomy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}]","[{'cui': 'C0243001', 'cui_str': 'Abscess, Intra-Abdominal'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0038941', 'cui_str': 'Postoperative Wound Infection'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}]",243.0,0.816238,"There was no difference between the sex (50F/72 M vs 47F/74 M, P = 0.8), median age (12.4 vs 12.2 years, P = 0.5), and postoperative length of stay in a hospital (27.2 vs 25.6 hours, P = 0.7).","[{'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Mennie', 'Affiliation': ""Department of Pediatric Surgery, Urology & Surgical Simulation, Monash Children's Hospital, Melbourne, Australia.""}, {'ForeName': 'Gayathri', 'Initials': 'G', 'LastName': 'Panabokke', 'Affiliation': ""Department of Pediatric Surgery, Urology & Surgical Simulation, Monash Children's Hospital, Melbourne, Australia.""}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Chang', 'Affiliation': ""Department of Pediatric Surgery, Urology & Surgical Simulation, Monash Children's Hospital, Melbourne, Australia.""}, {'ForeName': 'Sharman Tan', 'Initials': 'ST', 'LastName': 'Tanny', 'Affiliation': ""Department of Pediatric Surgery, Urology & Surgical Simulation, Monash Children's Hospital, Melbourne, Australia.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Cheng', 'Affiliation': 'Department of Pediatrics, School of Clinical Sciences, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Pacilli', 'Affiliation': ""Department of Pediatric Surgery, Urology & Surgical Simulation, Monash Children's Hospital, Melbourne, Australia.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Ferguson', 'Affiliation': ""Department of Pediatric Surgery, Urology & Surgical Simulation, Monash Children's Hospital, Melbourne, Australia.""}, {'ForeName': 'Ramesh M', 'Initials': 'RM', 'LastName': 'Nataraja', 'Affiliation': ""Department of Pediatric Surgery, Urology & Surgical Simulation, Monash Children's Hospital, Melbourne, Australia.""}]",Annals of surgery,['10.1097/SLA.0000000000003732']
845,29137895,A Four-kallikrein Panel and β-Microseminoprotein in Predicting High-grade Prostate Cancer on Biopsy: An Independent Replication from the Finnish Section of the European Randomized Study of Screening for Prostate Cancer.,"BACKGROUND


A panel of four kallikrein markers (total, free, and intact prostate-specific antigen [PSA] and human kallikrein-related peptidase 2 [hK2]) improves predictive accuracy for Gleason score ≥7 (high-grade) prostate cancer among men biopsied for elevated PSA. A four-kallikrein panel model was originally developed and validated by the Dutch center of the European Randomized Study of Screening for Prostate Cancer (ERSPC). The kallikrein panel is now commercially available as 4Kscore™.
OBJECTIVE


To assess whether these findings could be replicated among participants in the Finnish section of ERSPC (FinRSPC) and whether β-microseminoprotein (MSP), a candidate prostate cancer biomarker, adds predictive value.
DESIGN, SETTING, AND PARTICIPANTS


Among 4861 biopsied screening-positive participants in the first three screening rounds of FinRSPC, a case-control subset was selected that included 1632 biopsy-positive cases matched by age at biopsy to biopsy-negative controls.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS


The predictive accuracy of prespecified prediction models was compared with biopsy outcomes.
RESULTS AND LIMITATIONS


Among men with PSA of 4.0-25ng/ml, 1111 had prostate cancer, 318 of whom had high-grade disease. Total PSA and age predicted high-grade cancer with an area under the curve of 0.648 (95% confidence interval [CI] 0.614-0.681) and the four-kallikrein panel increased discrimination to 0.746 (95% CI 0.717-0.774). Adding MSP to the four-kallikrein panel led to a significant (Wald test; p=0.015) but small increase (0.003) in discrimination. Limitations include a risk of verification bias among men with PSA of 3.0-3.99ng/ml and the absence of digital rectal examination results.
CONCLUSIONS


These findings provide additional evidence that kallikrein markers can be used to inform biopsy decision-making. Further studies are needed to define the role of MSP.
PATIENT SUMMARY


Four kallikrein markers and β-microseminoprotein in blood improve discrimination of high-grade prostate cancer at biopsy in men with elevated prostate-specific antigen.",2019,Adding MSP to the four-kallikrein panel led to a significant (Wald test; p=0.015) but small increase (0.003) in discrimination.,"['High-grade Prostate Cancer on Biopsy', 'men with PSA of 4.0-25ng/ml, 1111 had prostate cancer, 318 of whom had high-grade disease', 'Among 4861 biopsied screening-positive participants in the first three screening rounds of FinRSPC, a case-control subset was selected that included 1632 biopsy-positive cases matched by age at biopsy to biopsy-negative controls', 'participants in the Finnish section of ERSPC (FinRSPC) and whether', 'men with elevated prostate-specific antigen', 'men with PSA of 3.0-3.99ng/ml and the absence of digital rectal examination results']","['Four kallikrein markers and β-microseminoprotein', 'kallikrein Panel and β-Microseminoprotein', 'β-microseminoprotein (MSP']",['Total PSA and age predicted high-grade cancer'],"[{'cui': 'C1962917', 'cui_str': 'High grade (lymphoma)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0178415', 'cui_str': 'Raised prostate specific antigen'}, {'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}, {'cui': 'C1384593', 'cui_str': 'Digital Rectal Examination'}, {'cui': 'C1274040', 'cui_str': 'Result'}]","[{'cui': 'C0022478', 'cui_str': 'kallidinogenase'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1962917', 'cui_str': 'High grade (lymphoma)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}]",4861.0,0.0933331,Adding MSP to the four-kallikrein panel led to a significant (Wald test; p=0.015) but small increase (0.003) in discrimination.,"[{'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Assel', 'Affiliation': 'Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Liisa', 'Initials': 'L', 'LastName': 'Sjöblom', 'Affiliation': 'Prostate Cancer Research Center, Institute of Biosciences and Medical Technology, University of Tampere, Tampere, Finland; Fimlab Laboratories, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Teemu J', 'Initials': 'TJ', 'LastName': 'Murtola', 'Affiliation': 'Prostate Cancer Research Center, School of Health Sciences, University of Tampere, Tampere, Finland; Department of Urology, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Kirsi', 'Initials': 'K', 'LastName': 'Talala', 'Affiliation': 'Finnish Cancer Registry, Helsinki, Finland.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Kujala', 'Affiliation': 'Fimlab Laboratories, Tampere University Hospital, Tampere, Finland; Department of Pathology, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Ulf-Håkan', 'Initials': 'UH', 'LastName': 'Stenman', 'Affiliation': 'Department of Clinical Chemistry, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Kimmo', 'Initials': 'K', 'LastName': 'Taari', 'Affiliation': 'Department of Urology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Anssi', 'Initials': 'A', 'LastName': 'Auvinen', 'Affiliation': 'Prostate Cancer Research Center, School of Health Sciences, University of Tampere, Tampere, Finland.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Vickers', 'Affiliation': 'Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Tapio', 'Initials': 'T', 'LastName': 'Visakorpi', 'Affiliation': 'Prostate Cancer Research Center, Institute of Biosciences and Medical Technology, University of Tampere, Tampere, Finland; Fimlab Laboratories, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Teuvo L', 'Initials': 'TL', 'LastName': 'Tammela', 'Affiliation': 'Prostate Cancer Research Center, School of Health Sciences, University of Tampere, Tampere, Finland; Department of Urology, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Lilja', 'Affiliation': 'Prostate Cancer Research Center, Institute of Biosciences and Medical Technology, University of Tampere, Tampere, Finland; Departments of Laboratory Medicine, Surgery, and Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK; Department of Translational Medicine, Lund University, Malmö, Sweden. Electronic address: liljah@mskcc.org.'}]",European urology focus,['10.1016/j.euf.2017.11.002']
846,28820855,Resistance exercise order does not affect the magnitude and duration of post-exercise blood pressure in older women.,"The aim of this study was to compare the effects of two resistance exercise order on post-exercise blood pressure (BP) in trained, non-hypertensive older women. Sixteen women (68.3 ± 3.3 years, 63.5 ± 11.6 kg, 157.5 ± 5.1 cm) performed two sessions witheight exercises (3 sets of 8-12 repetitions) in distinct orders (from multi- to single-joint exercises [MS] or from single- to multi-joint exercises [SM]) and a control session, without exercise. Blood pressure and heart rate were obtained pre and post-sessions (60 min). Post-exercise hypotension was observed for systolic and mean BP in both the MS session (systolic BP: -6.9 mmHg, mean BP: -3.3 mmHg, P< 0.05) and SM session (systolic BP: -4.6 mmHg; mean BP: -1.1 mmHg). Post-exercise heart rate was higher than pre-session values until 30 min of recovery in both training sessions. Furthermore, systolic and mean blood pressure, and heart rate were lower than the values obtained in the control session (30 to 60 min and 0 min, respectively; P<0.05). There were no differences between the SM and MS sessions in any variable or at any moment. In conclusion, resistance exercise order does not interfere in the magnitude and duration of post-exercise hypotension in trained, non-hypertensive older women.",2017,There were no differences between the SM and MS sessions in any variable or at any moment.,"['Sixteen women (68.3 ± 3.3 years, 63.5 ± 11.6 kg, 157.5 ± 5.1 cm) performed two', 'trained, non-hypertensive older women', 'older women', 'hypertensive older women']","['resistance exercise order on post-exercise blood pressure (BP', 'Resistance exercise', 'sessions witheight exercises (3 sets of 8-12 repetitions) in distinct orders (from multi- to single-joint exercises [MS] or from single- to multi-joint exercises [SM]) and a control session, without exercise']","['Post-exercise heart rate', 'Furthermore, systolic and mean blood pressure, and heart rate', 'Blood pressure and heart rate', 'magnitude and duration of post-exercise blood pressure', 'systolic and mean BP']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4517688', 'cui_str': '3.3 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4708782', 'cui_str': '11.6'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}, {'cui': 'C1979962', 'cui_str': 'After exercise (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C1979962', 'cui_str': 'After exercise (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C1704240', 'cui_str': 'Magnitudes (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",,0.0338416,There were no differences between the SM and MS sessions in any variable or at any moment.,"[{'ForeName': 'Crisieli M', 'Initials': 'CM', 'LastName': 'Tomeleri', 'Affiliation': 'a Metabolism, Nutrition, and Exercise Laboratory. Londrina State University. Londrina, Brazil. b Department of Physical Education, Federal University of Vale do São Francisco, Petrolina, Brazil. c Department of Physical Education, Federal University of Santa Catarina, Florianópolis, Santa Catarina, Brazil. d Department of Physical Education, Faculty of Physical Education and Sport, State University of Londrina, Londrina, PR, Brazil.'}, {'ForeName': 'João Pedro', 'Initials': 'JP', 'LastName': 'Nunes', 'Affiliation': ''}, {'ForeName': 'Mariana F', 'Initials': 'MF', 'LastName': 'Souza', 'Affiliation': ''}, {'ForeName': 'Aline', 'Initials': 'A', 'LastName': 'Gerage', 'Affiliation': ''}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Marcori', 'Affiliation': ''}, {'ForeName': 'Kessi Cassiane', 'Initials': 'KC', 'LastName': 'Iarosz', 'Affiliation': ''}, {'ForeName': 'Crivaldo Gomes', 'Initials': 'CG', 'LastName': 'Cardoso-Júnior', 'Affiliation': ''}, {'ForeName': 'Edilson S', 'Initials': 'ES', 'LastName': 'Cyrino', 'Affiliation': ''}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002177']
847,31539674,The impact of prolonged exposure therapy on social support and PTSD symptoms.,"BACKGROUND


Posttraumatic stress disorder (PTSD) results in high costs to society, particularly among military personnel. Much is known about PTSD treatments-such as exposure therapies-and their outcomes, but less is known about how treatment might impact social support and PTSD symptoms over the course of treatment.
METHODS


In the current study, soldiers with PTSD (N = 162) were randomized to complete prolonged exposure therapy (either with or without virtual reality) or a waitlist control condition. We examined the impact of treatment on perceived social support as a secondary treatment outcome, as well as the associations between social support and PTSD symptoms over time.
RESULTS


Exposure therapy increased perceived social support at the end of treatment compared to waitlist control, β = 0.43, 95% CI [0.13, 0.73]. Multigroup structural equation modeling using a cross-lagged panel design provided evidence that perceived social support was an antecedent of PTSD symptom improvement for participants engaging in treatment, but not for participants in the waitlist control. Treatment effects on change in PTSD symptoms was mediated by change in perceived social support (B = 1.10, 95% CI [0.20, 3.05]).
LIMITATIONS


The results should be considered in light of limitations, including the characteristics of the sample of active duty soldiers, the measurement of social support, and missingess over the course of the study.
CONCLUSIONS


These results suggest that increased perceived social support is a secondary outcome of exposure therapy and may be one pathway through which treatment reduces PTSD symptoms.",2020,"RESULTS


Exposure therapy increased perceived social support at the end of treatment compared to waitlist control, β = 0.43, 95% CI [0.13, 0.73].",['soldiers with PTSD (N\u202f=\u202f162'],"['prolonged exposure therapy', 'complete prolonged exposure therapy (either with or without virtual reality) or a waitlist control condition']","['perceived social support', 'social support and PTSD symptoms', 'PTSD symptoms']","[{'cui': 'C0524647', 'cui_str': 'Soldiers'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}]","[{'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0037438'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0144893,"RESULTS


Exposure therapy increased perceived social support at the end of treatment compared to waitlist control, β = 0.43, 95% CI [0.13, 0.73].","[{'ForeName': 'K J', 'Initials': 'KJ', 'LastName': 'Bourassa', 'Affiliation': 'VA Puget Sound Healthcare System, United States; University of Arizona, Department of Psychology, United States; Duke University Medical Center, Center for the Study of Aging and Human Development, United States.'}, {'ForeName': 'D J', 'Initials': 'DJ', 'LastName': 'Smolenski', 'Affiliation': 'Defense Health Agency, Psychological Health Center of Excellence, United States.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Edwards-Stewart', 'Affiliation': 'Defense Health Agency, Psychological Health Center of Excellence, United States.'}, {'ForeName': 'S B', 'Initials': 'SB', 'LastName': 'Campbell', 'Affiliation': 'VA Puget Sound Healthcare System, United States; University of Washington School of Medicine, United States.'}, {'ForeName': 'G M', 'Initials': 'GM', 'LastName': 'Reger', 'Affiliation': 'VA Puget Sound Healthcare System, United States; University of Washington School of Medicine, United States. Electronic address: greg.reger@va.gov.'}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Norr', 'Affiliation': 'VISN 20 Northwest Network Mental Illness Research, Education and Clinical Center (MIRECC), United States; University of Washington School of Medicine, United States.'}]",Journal of affective disorders,['10.1016/j.jad.2019.09.036']
848,28537581,The effects of a multispecies probiotic on migraine and markers of intestinal permeability-results of a randomized placebo-controlled study.,"BACKGROUND/OBJECTIVES


Migraine, associated with several gastrointestinal disorders, may result from increased intestinal permeability, allowing endotoxins to enter the bloodstream. We tested whether probiotics could reduce migraine through an effect on intestinal permeability and inflammation.
SUBJECTS/METHODS


In total, 63 patients were randomly allocated to the probiotic (n=31) or the placebo group (n=32). Participants ingested a multispecies probiotic (5x10 9  colony-forming units) or placebo daily for 12 weeks. Migraine was assessed with the Migraine Disability Assessment Scale (MIDAS), the Headache Disability Inventory (HDI) and headache diaries. At baseline and 12 weeks, intestinal permeability was measured with the urinary lactulose/mannitol test and fecal and serum zonulin; inflammation was measured from interleukin (IL) -6, IL-10, tumor necrosis factor-α and C-reactive protein in serum.
RESULTS


The MIDAS migraine intensity score significantly decreased in both groups (P<0.001) and the HDI score significantly decreased in the probiotic group (P=0.032) and borderline in the placebo group (P=0.053). In the probiotics group, patients had a median of 6 migraine days in the first month, 4 in the second month (P=0.002) and 5 in the last month, which was not significantly different from the 5, 4, and 4 days in the placebo group. A ⩾2day reduction in migraine days was seen in 12/31 patients in the probiotics group versus 7/29 in the placebo group (ns). Probiotic use did not significantly affect medication use, intestinal permeability or inflammation compared to placebo.
CONCLUSIONS


In this study, we could not confirm significant benefit from a multispecies probiotic compared to a placebo on the outcome parameters of migraine and intestinal integrity.",2017,The MIDAS migraine intensity score significantly decreased in both groups (P<0.001) and the HDI score significantly decreased in the probiotic group (P=0.032) and borderline in the placebo group (P=0.053).,['63 patients'],"['multispecies probiotic', 'multispecies probiotic (5x10 9  colony-forming units) or placebo', 'placebo', 'probiotic']","['intestinal permeability', 'urinary lactulose/mannitol test and fecal and serum zonulin; inflammation', 'medication use, intestinal permeability or inflammation', 'HDI score', 'intestinal permeability and inflammation', 'migraine and intestinal integrity', 'IL-10, tumor necrosis factor-α and C-reactive protein in serum', 'MIDAS migraine intensity score', 'Migraine Disability Assessment Scale (MIDAS), the Headache Disability Inventory (HDI) and headache diaries']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0439158', 'cui_str': 'colonies (qualifier value)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}, {'cui': 'C0022957', 'cui_str': 'Lactulose'}, {'cui': 'C0887166', 'cui_str': '(L)-Mannitol'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0914216', 'cui_str': 'prehaptoglobin 2'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C1947912', 'cui_str': 'Integrity (attribute)'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0041368', 'cui_str': 'Tumor Necrosis Factors'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C3854497', 'cui_str': 'Disability assessment scale'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0376660', 'cui_str': 'Diary'}]",63.0,0.232466,The MIDAS migraine intensity score significantly decreased in both groups (P<0.001) and the HDI score significantly decreased in the probiotic group (P=0.032) and borderline in the placebo group (P=0.053).,"[{'ForeName': 'N M', 'Initials': 'NM', 'LastName': 'de Roos', 'Affiliation': 'Wageningen UR, Division Human Nutrition and Epidemiology, Wageningen University, Wageningen, The Netherlands.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'van Hemert', 'Affiliation': 'Winclove b.v., Innovation Department, Amsterdam, The Netherlands.'}, {'ForeName': 'J M P', 'Initials': 'JMP', 'LastName': 'Rovers', 'Affiliation': 'Hospital Gelderse Vallei, Department of Neurology, Ede, The Netherlands.'}, {'ForeName': 'M G', 'Initials': 'MG', 'LastName': 'Smits', 'Affiliation': 'Hospital Gelderse Vallei, Department of Neurology, Ede, The Netherlands.'}, {'ForeName': 'B J M', 'Initials': 'BJM', 'LastName': 'Witteman', 'Affiliation': 'Wageningen UR, Division Human Nutrition and Epidemiology, Wageningen University, Wageningen, The Netherlands.'}]",European journal of clinical nutrition,['10.1038/ejcn.2017.57']
849,32412181,Live lectures and videos do not differ in relation to learning outcomes of dental ergonomics.,"OBJECTIVES


This study aimed to compare the knowledge attained by third-year dental students in physical ergonomics altering live lectures and videos in teaching. The second aim was to investigate implementation of the theoretical knowledge on ergonomics into practice.
MATERIAL AND METHODS


Forty-five students divided into two groups attended a live lecture (45 min) or viewed videos (45 min). After the first teaching session, the groups changed parts. All students answered a questionnaire with 13 true or false-questions on ergonomics at baseline and immediately after both teaching sessions. Friedman's test and Wilcoxon signed rank test were used to compare questionnaire scores of the student groups. Additionally, we photographed 17 randomly selected students 3 months after baseline during a simulation workshop on endodontics. We analyzed the photographs for ergonomic postures using a specific 12-point checklist.
RESULTS


At baseline, no difference in the knowledge between the two groups was discovered, when both scored 72%. After the first teaching session, significant improvement in both groups (p < .05) was found; and there was no statistically significant difference in the scores between the groups (88% in the lecture-first and 82% in the video-first group). After the second teaching session, the scores were similar in both groups. Overall all improvement in both groups was significant (p < .001). The photograph analysis showed half of the postures being in accord with the ergonomic guidelines.
CONCLUSIONS


Both live lectures and videos showed similar outcomes in teaching ergonomics. Implementation of the knowledge on ergonomics is insufficient. Videos provide an easy-to-organize alternative to live lectures in teaching dental ergonomics. New means are needed to have dental students implement their knowledge on ergonomics into practice.",2020,"After the first teaching session, significant improvement in both groups (p < .05) was found; and there was no statistically significant difference in the scores between the groups (88% in the lecture-first and 82% in the video-first group).","['Forty-five students divided into two groups attended a', 'third-year dental students in physical ergonomics altering live lectures and videos in teaching']",['live lecture (45\u2009min) or viewed videos'],['questionnaire scores'],"[{'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038493', 'cui_str': 'Dental Student'}, {'cui': 'C4505395', 'cui_str': 'Physical Ergonomics'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0039401', 'cui_str': 'Education'}]","[{'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0042655', 'cui_str': 'Video'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",17.0,0.0185547,"After the first teaching session, significant improvement in both groups (p < .05) was found; and there was no statistically significant difference in the scores between the groups (88% in the lecture-first and 82% in the video-first group).","[{'ForeName': 'Jukka', 'Initials': 'J', 'LastName': 'Leinonen', 'Affiliation': 'Department of Clinical Dentistry, UiT The Arctic University of Norway, Tromso, Norway.'}, {'ForeName': 'Marja-Liisa', 'Initials': 'ML', 'LastName': 'Laitala', 'Affiliation': 'Department of Clinical Dentistry, UiT The Arctic University of Norway, Tromso, Norway.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Pirttilahti', 'Affiliation': 'Department of Clinical Dentistry, UiT The Arctic University of Norway, Tromso, Norway.'}, {'ForeName': 'Leena', 'Initials': 'L', 'LastName': 'Niskanen', 'Affiliation': 'Department of Clinical Dentistry, UiT The Arctic University of Norway, Tromso, Norway.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Pesonen', 'Affiliation': 'Infrastructure for Population Studies, Faculty of Medicine, University of Oulu, Oulu, Finland.'}, {'ForeName': 'Vuokko', 'Initials': 'V', 'LastName': 'Anttonen', 'Affiliation': 'Department of Clinical Dentistry, UiT The Arctic University of Norway, Tromso, Norway.'}]",Clinical and experimental dental research,['10.1002/cre2.300']
850,28739318,Impact of biannual treatment with fluoride varnish on tooth-surface-level caries progression in children aged 1-3 years.,"OBJECTIVE


This study describes caries progression at tooth-surface level in children from 1 to 3 years of age and the impact of biannual treatment with fluoride varnish.
METHODS


Children who participated in a cluster-randomized controlled trial and had shown signs of dental caries were included in this study (n=801). International Caries Detection and Assessment System (ICDAS) was used to classify dental caries. The present study compared children receiving a standard yearly intervention to children receiving the same standard preventive intervention supplemented with an application of fluoride varnish every half year.
RESULTS


The maxillary incisors were the first teeth to develop cavitation (ICDAS 3-6) and also mostly affected. Further analyses focusing on maxillary incisors buccal surfaces showed that sound surfaces had least progression and that progression to extensive decay was more common in teeth that had exhibited moderate decay. A summarizing progression index (PI) was calculated for the buccal surfaces of the maxillary incisors. Between 1 and 2 years of age PI was 26% and between 2 and 3 years of age PI was 21%. The progression on buccal incisors and on occlusal first primary molars did not differ between intervention groups (p≤0,05).
CONCLUSION


No impact on caries progression for biannual treatment with fluoride varnish was found.
CLINICAL SIGNIFICANCE


Using fluoride varnish as a complement to standard intervention in toddlers did not add in the prevention of dental caries or its progression. The education of parents in the use fluoride toothpaste as they start brushing the teeth of their children is essential.",2017,"The progression on buccal incisors and on occlusal first primary molars did not differ between intervention groups (p≤0,05).
","['children receiving a standard yearly intervention to children receiving the same', 'caries progression at tooth-surface level in children from 1 to 3 years of age and the impact of biannual treatment with fluoride varnish', 'children aged 1-3 years', 'Children who participated in a cluster-randomized controlled trial and had shown signs of dental caries were included in this study (n=801']","['fluoride toothpaste', 'fluoride varnish', 'standard preventive intervention supplemented with an application of fluoride varnish every half year']","['tooth-surface-level caries progression', 'caries progression', 'progression index (PI']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0447301', 'cui_str': 'Tooth surface (body structure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0016326', 'cui_str': 'Fluoride Varnishes'}, {'cui': 'C1096777', 'cui_str': 'Randomized Controlled Trial'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0011334', 'cui_str': 'Dental Decay'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0016327', 'cui_str': 'Fluorides'}, {'cui': 'C0040462', 'cui_str': 'Toothpaste'}, {'cui': 'C0016326', 'cui_str': 'Fluoride Varnishes'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1456501', 'cui_str': 'Preventive'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0447301', 'cui_str': 'Tooth surface (body structure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0333519', 'cui_str': 'Caries (morphologic abnormality)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",801.0,0.0542311,"The progression on buccal incisors and on occlusal first primary molars did not differ between intervention groups (p≤0,05).
","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Anderson', 'Affiliation': 'Department of Dental Medicine (DENTMED), OF, Division 6, Pedodontics, Box 4064, 141 04, Huddinge, Sweden; Pediatric Dentistry, Public Dental Service, Eastman Institute, Dalagatan 11, SE-11324, Stockholm, Sweden. Electronic address: maria.anderson@ki.se.'}, {'ForeName': 'Göran', 'Initials': 'G', 'LastName': 'Dahllöf', 'Affiliation': 'Department of Dental Medicine (DENTMED), OF, Division 6, Pedodontics, Box 4064, 141 04, Huddinge, Sweden; Center for Pediatric Oral Health Research, Pediatric Dentistry, Public Dental Service, Eastman Institute, Dalagatan 11, SE-11324, Stockholm, Sweden. Electronic address: goran.dahllof@ki.se.'}, {'ForeName': 'Fernanda Cunha', 'Initials': 'FC', 'LastName': 'Soares', 'Affiliation': 'Department of Dental Medicine (DENTMED), OF, Division 6, Pedodontics, Box 4064, 141 04, Huddinge, Sweden. Electronic address: fernanda.cunha.soares@ki.se.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Grindefjord', 'Affiliation': 'Department of Dental Medicine (DENTMED), OF, Division 6, Pedodontics, Box 4064, 141 04, Huddinge, Sweden; Pediatric Dentistry, Public Dental Service, Eastman Institute, Dalagatan 11, SE-11324, Stockholm, Sweden; Center for Pediatric Oral Health Research, Pediatric Dentistry, Public Dental Service, Eastman Institute, Dalagatan 11, SE-11324, Stockholm, Sweden. Electronic address: margaret.grindefjord@ki.se.'}]",Journal of dentistry,['10.1016/j.jdent.2017.07.009']
851,29109107,Web-based Social Media Intervention to Increase Vaccine Acceptance: A Randomized Controlled Trial.,"BACKGROUND


Interventions to address vaccine hesitancy and increase vaccine acceptance are needed. This study sought to determine if a Web-based, social media intervention increases early childhood immunization.
METHODS


A 3-arm, randomized controlled trial was conducted in Colorado from September 2013 to July 2016. Participants were pregnant women, randomly assigned (3:2:1) to a Web site with vaccine information and interactive social media components (VSM), a Web site with vaccine information (VI), or usual care (UC). Vaccination was assessed in infants of participants from birth to age 200 days. The primary outcome was days undervaccinated, measured as a continuous and dichotomous variable.
RESULTS


Infants of 888 participants were managed for 200 days. By using a nonparametric rank-based analysis, mean ranks for days undervaccinated were significantly lower in the VSM arm versus UC ( P  = .02) but not statistically different between the VI and UC ( P  = .08) or between VSM and VI arms ( P  = .63). The proportions of infants up-to-date at age 200 days were 92.5, 91.3, and 86.6 in the VSM, VI, and UC arms, respectively. Infants in the VSM arm were more likely to be up-to-date than infants in the UC arm (odds ratio [OR] = 1.92; 95% confidence interval [CI], 1.07-3.47). Up-to-date status was not statistically different between VI and UC arms (OR = 1.62; 95% CI, 0.87-3.00) or between the VSM and VI arms (OR = 1.19, 95% CI, 0.70-2.03).
CONCLUSIONS


Providing Web-based vaccine information with social media applications during pregnancy can positively influence parental vaccine behaviors.",2017,"Up-to-date status was not statistically different between VI and UC arms (OR = 1.62; 95% CI, 0.87-3.00) or between the VSM and VI arms (OR = 1.19, 95% CI, 0.70-2.03).
","['Participants were pregnant women', 'Infants of 888 participants were managed for 200 days', 'infants of participants from birth to age 200 days', 'Colorado from September 2013 to July 2016']","['Web-based Social Media Intervention', 'social media intervention', 'vaccine information and interactive social media components (VSM), a Web site with vaccine information (VI), or usual care (UC']","['Vaccination', 'Vaccine Acceptance']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0009399', 'cui_str': 'Colorado'}]","[{'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3179065', 'cui_str': 'Social Media'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}]",888.0,0.309915,"Up-to-date status was not statistically different between VI and UC arms (OR = 1.62; 95% CI, 0.87-3.00) or between the VSM and VI arms (OR = 1.19, 95% CI, 0.70-2.03).
","[{'ForeName': 'Jason M', 'Initials': 'JM', 'LastName': 'Glanz', 'Affiliation': 'Institute for Health Research, Kaiser Permanente Colorado, Denver, Colorado; jason.m.glanz@kp.org.'}, {'ForeName': 'Nicole M', 'Initials': 'NM', 'LastName': 'Wagner', 'Affiliation': 'Institute for Health Research, Kaiser Permanente Colorado, Denver, Colorado.'}, {'ForeName': 'Komal J', 'Initials': 'KJ', 'LastName': 'Narwaney', 'Affiliation': 'Institute for Health Research, Kaiser Permanente Colorado, Denver, Colorado.'}, {'ForeName': 'Courtney R', 'Initials': 'CR', 'LastName': 'Kraus', 'Affiliation': 'Institute for Health Research, Kaiser Permanente Colorado, Denver, Colorado.'}, {'ForeName': 'Jo Ann', 'Initials': 'JA', 'LastName': 'Shoup', 'Affiliation': 'Institute for Health Research, Kaiser Permanente Colorado, Denver, Colorado.'}, {'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Xu', 'Affiliation': 'Institute for Health Research, Kaiser Permanente Colorado, Denver, Colorado.'}, {'ForeName': 'Sean T', 'Initials': 'ST', 'LastName': ""O'Leary"", 'Affiliation': 'Department of Pediatrics, University of Colorado School of Medicine, Aurora, Colorado; and.'}, {'ForeName': 'Saad B', 'Initials': 'SB', 'LastName': 'Omer', 'Affiliation': 'Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Kathy S', 'Initials': 'KS', 'LastName': 'Gleason', 'Affiliation': 'Institute for Health Research, Kaiser Permanente Colorado, Denver, Colorado.'}, {'ForeName': 'Matthew F', 'Initials': 'MF', 'LastName': 'Daley', 'Affiliation': 'Institute for Health Research, Kaiser Permanente Colorado, Denver, Colorado.'}]",Pediatrics,['10.1542/peds.2017-1117']
852,29016544,"Investigation of the Efficacy and Safety of Topical Vibration Anesthesia to Reduce Pain From Cosmetic Botulinum Toxin A Injections in Chinese Patients: A Multicenter, Randomized, Self-Controlled Study.","BACKGROUND


Vibration has been proved to be effective to reduce pain during facial cosmetic injections, but it has not been studied in Chinese patients.
OBJECTIVE


To investigate the efficacy and safety of vibration for pain reduction associated with cosmetic botulinum toxin A (BTX-A) injections in Chinese patients.
MATERIALS AND METHODS


In this prospective, randomized, split-face and right-left, self-controlled study, 53 patients received BTX-A injections for rhytid reduction, lower face, shoulder, and leg reshaping. Injections were given in a split-face and right-left design randomly assigned. A vibration stimulus was coadministered with BTX-A injections on one side, whereas the other side received BTX-A injections only. Patients completed a questionnaire immediately after treatment and were followed up 2 weeks later. A visual analog scale of pain sensation was statistically analyzed.
RESULTS


The patients experienced both clinically and statistically significant pain reduction when a vibration was coadministered with injections. Patients reported less pain on the treated side compared with the control side. Overall, 75% of patients preferred to receive vibration with their next treatment. No adverse events were reported.
CONCLUSION


Vibration is an effective and safe way to reduce pain during cosmetic BTX-A injections and may have applications in other cosmetic procedures.",2017,"No adverse events were reported.
","['53 patients received', 'Chinese Patients', 'Chinese patients']","['Botulinum Toxin A Injections', 'Vibration', 'cosmetic botulinum toxin A', 'BTX-A injections', 'Topical Vibration Anesthesia']","['pain reduction', 'pain', 'adverse events', 'visual analog scale of pain sensation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}]","[{'cui': 'C0006055', 'cui_str': 'Botulin'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0459800', 'cui_str': 'Vibration'}, {'cui': 'C0442965', 'cui_str': 'Cosmetic procedure (qualifier value)'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0036658', 'cui_str': 'Sensory Function'}]",,0.0242798,"No adverse events were reported.
","[{'ForeName': 'Yiming', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': '*Department of Dermatology and Venereology, Huaxi Hospital, Chengdu, China; †Department of Dermatology, Sichuan FreSkin Hospital, Chengdu, China; ‡Department of Dermatology, Xian FreSkin Hospital, Xian, China; §Department of Dermatology, Chongqing FreSkin Hospital, Chongqing, China.'}, {'ForeName': 'Weiwei', 'Initials': 'W', 'LastName': 'Dong', 'Affiliation': ''}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Xu', 'Affiliation': ''}]",Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.],['10.1097/DSS.0000000000001349']
853,31896035,Using branching path simulations in critical thinking of pain management among nursing students: Experimental study.,"BACKGROUND


Nursing education has to promote nursing students' critical thinking skills especially those who are going to work with people with dementia suffering from pain. Therefore, nursing education needs to incorporate new and effective teaching methods in nursing curricula for critical thinking skills promotion. Branching path simulation is an interactive learning tool which helps students; (1) to make decisions about treatment options for patients and get feedback immediately and (2) to demonstrate and promote their critical thinking skills in a safe and supported environment before dealing with complex and real-life case scenarios.
OBJECTIVES


The present study aimed to examine the effectiveness of branching path simulation in promoting the critical thinking skills of undergraduate nursing students.
METHODS


This an equivalent control group pretest-posttest experimental study was done in 2019 on 102 undergraduate nursing students who had registered in both practical and theoretical courses of Advanced Adult Health Nursing. A pretest posttest experimental design with concurrent control group and random assignment to the treatment/nontreatment variable was used and a convenience sample of 102 nursing students was recruited in this study. The students were randomly assigned and divided into two equal intervention and control groups and each group attended different training sessions. The control group was trained by traditional lectures while the intervention group was trained by branching path simulation. The researcher used a demographic questionnaire and the Critical Thinking Self-Assessment Scale (CTSAS) for data collection.
RESULTS


After the training sessions, the mean scores of the CTSAS and its subscales domain in the intervention group were significantly higher than the control group.
CONCLUSIONS


Branching path simulation is an effective teaching method to promote students' critical thinking skills. Future studies are recommended to examine the effect of branching path simulation on other nursing students learning outcomes.",2020,"After the training sessions, the mean scores of the CTSAS and its subscales domain in the intervention group were significantly higher than the control group.
","['nursing students', '102 undergraduate nursing students who had registered in both practical and theoretical courses of Advanced Adult Health Nursing', 'undergraduate nursing students', 'people with dementia suffering from pain', '102 nursing students']",['branching path simulation'],['mean scores of the CTSAS and its subscales domain'],"[{'cui': 'C0038496', 'cui_str': 'Pupil Nurses'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0028678', 'cui_str': 'nursing care'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0205384', 'cui_str': 'Branching (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}]",,0.0200601,"After the training sessions, the mean scores of the CTSAS and its subscales domain in the intervention group were significantly higher than the control group.
","[{'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Rababa', 'Affiliation': 'Department of Adult Health Nursing, Faculty of Nursing, Jordan University of Science and Technology, Irbid, Jordan. Electronic address: mjrababa@just.edu.jo.'}, {'ForeName': 'Dina', 'Initials': 'D', 'LastName': ""Masha'al"", 'Affiliation': 'Department of Adult Health Nursing, Faculty of Nursing, Jordan University of Science and Technology, Irbid, Jordan.'}]",Nurse education today,['10.1016/j.nedt.2019.104323']
854,31594205,Intra-articular distension preceded by physical therapy versus intra-articular distension followed by physical therapy for treating adhesive capsulitis of the shoulder.,"BACKGROUND


Intra-articular distension is a validated treatment in adhesive capsulitis of the shoulder and is commonly followed by intensive in-patient physical therapy. A recent meta-analysis found that physical therapy is as effective as intra-articular distension (IAD) and that an early distension could be the primary choice for treating frozen shoulder. The question of the additional contribution of physical therapy prior to IAD compared with IAD followed by physical therapy has not been raised.
OBJECTIVES


We compared IAD preceded by physical therapy to that followed by physical therapy in terms of pain relief and functional outcome.
METHODS


We enrolled patients with primitive adhesive capsulitis of the shoulder. The eligible patients were randomized into three groups: A, B and C. Group A received intra-articular distension followed by physical therapy, group B received intra-articular distension in the middle of physical therapy and group C received physical therapy alone. Patients were assessed at the beginning of the protocol (T0), after 6 weeks (T1) and after 12 weeks (T2). The main outcome measures were pain using a Visual Analog Scale and the Disabilities of Arm, Shoulder and Hand Questionnaire.
RESULTS


Out of the 179 enrolled patients, only 122 completed the follow up: group A (n= 34), group B (n= 46) and group C (n= 42). Compared to intra-articular distension preceded by physical therapy, IAD followed by physical therapy did not improve significantly the outcome in terms of pain relief (p= 0.123) but it enhanced the upper extremity function (p= 0.002). Upper extremity pain and function were found to improve with time regardless of the protocol (p< 0.001).
CONCLUSIONS


IAD followed by physical therapy is more beneficial than IAD preceded by physical therapy in terms of upper extremity function. IAD, whether or not preceded by physical therapy, does not significantly improve pain compared to physical therapy alone. Time is a crucial factor to take into consideration while treating adhesive capsulitis of the shoulder.",2020,"Upper extremity pain and function were found to improve with time regardless of the protocol (p< 0.001).
","['179 enrolled patients', 'enrolled patients with primitive adhesive capsulitis of the shoulder']","['physical therapy versus intra-articular distension followed by physical therapy', 'intra-articular distension followed by physical therapy, group B received intra-articular distension in the middle of physical therapy and group C received physical therapy alone']","['pain', 'pain relief and functional outcome', 'pain relief', 'upper extremity function', 'Upper extremity pain and function', 'pain using a Visual Analog Scale and the Disabilities of Arm, Shoulder and Hand Questionnaire']","[{'cui': 'C4517609', 'cui_str': '179 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3645627', 'cui_str': 'Primitive'}, {'cui': 'C0311223', 'cui_str': 'Shoulder Adhesive Capsulitis'}]","[{'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0442108', 'cui_str': 'Intra-articular (qualifier value)'}, {'cui': 'C3714614', 'cui_str': 'Distention'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0441837', 'cui_str': 'Group C (qualifier value)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C1997924', 'cui_str': 'Disability of arm'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",179.0,0.0190494,"Upper extremity pain and function were found to improve with time regardless of the protocol (p< 0.001).
","[{'ForeName': 'Anis', 'Initials': 'A', 'LastName': 'Jellad', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Faculty of Medicine, University Hospital of Monastir, University of Monastir, Monastir, Tunisia.'}, {'ForeName': 'Wafa', 'Initials': 'W', 'LastName': 'May', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Faculty of Medicine, University Hospital of Monastir, University of Monastir, Monastir, Tunisia.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Zrig', 'Affiliation': 'Department of Radiology, Faculty of Medicine, University Hospital of Monastir, University of Monastir, Monastir, Tunisia.'}, {'ForeName': 'Amine', 'Initials': 'A', 'LastName': 'Kalai', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Faculty of Medicine, University Hospital of Monastir, University of Monastir, Monastir, Tunisia.'}, {'ForeName': 'Mahbouba', 'Initials': 'M', 'LastName': 'Jguirim', 'Affiliation': 'Department of Rheumatology, Faculty of Medicine, University Hospital of Monastir, University of Monastir, Monastir, Tunisia.'}, {'ForeName': 'Zohra Ben Salah', 'Initials': 'ZBS', 'LastName': 'Frih', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Faculty of Medicine, University Hospital of Monastir, University of Monastir, Monastir, Tunisia.'}, {'ForeName': 'Mondher', 'Initials': 'M', 'LastName': 'Golli', 'Affiliation': 'Department of Radiology, Faculty of Medicine, University Hospital of Monastir, University of Monastir, Monastir, Tunisia.'}]",Journal of back and musculoskeletal rehabilitation,['10.3233/BMR-181426']
855,28689006,Interactions between pro-inflammatory cytokines and statins on depression in patients with acute coronary syndrome.,"OBJECTIVE


Pro-inflammatory cytokines are associated with the development of depression and statins exert anti-inflammatory and antidepressant effects. The present study aimed to investigate associations between interleukin (IL)-6 and IL-18 and depression in patients with acute coronary syndrome (ACS) and potential interactions between statin use and pro-inflammatory cytokines on depression in this population.
METHODS


We used pooled datasets from 1-year follow-up data from a 24-week randomized double-blind placebo-controlled trial (RCT) of escitalopram for treatment of depressive disorder and data from a naturalistic, prospective, observational cohort study in patients with ACS. IL-6 and IL-18 levels were measured at baseline. Logistic regression models were used to investigate independent associations of IL-6/IL-18 levels with depressive disorder at baseline and at 1year. We repeated all analyses by reference to statin use to determine whether any significant association emerged.
RESULTS


Of the 969 participants, 378 (39.0%) had major or minor depression at baseline. Of 711 patients followed-up at 1year, 183 (25.7%) had depression. Logistic regression analysis showed that higher IL-6 and IL-18 levels at baseline were significantly associated with baseline depression after adjusting for other variables (adjusted p-values=0.005 and 0.001, respectively). IL-6 and IL-18 levels were also significantly higher in patients with depression at the 1-year follow-up after adjusting for other variables amongst those not taking statins (adjusted p-values=0.040 and 0.004, respectively); but this was not the case in patients taking statins.
CONCLUSION


Levels of pro-inflammatory cytokines appear to predict development of depression after ACS and statins attenuate the effects of cytokines on depression.",2018,IL-6,"['patients with acute coronary syndrome (ACS', 'patients with acute coronary syndrome', '711 patients followed-up at 1year, 183 (25.7%) had depression', 'patients with ACS', 'Of the 969 participants, 378 (39.0%) had major or minor depression at baseline']","['interleukin (IL)-6 and IL-18 and depression', 'IL-6', 'placebo-controlled trial (RCT) of escitalopram']","['IL-6 and IL-18 levels', 'and IL-18 levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C4517615', 'cui_str': 'One hundred and eighty-three'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0026193', 'cui_str': 'Minors'}]","[{'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0383327', 'cui_str': 'Interferon-gamma-Inducing Factor'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1099456', 'cui_str': 'Escitalopram'}]","[{'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0383327', 'cui_str': 'Interferon-gamma-Inducing Factor'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",969.0,0.247462,IL-6,"[{'ForeName': 'Sung-Wan', 'Initials': 'SW', 'LastName': 'Kim', 'Affiliation': 'Department of Psychiatry, Chonnam National University Medical School, Gwangju, Republic of Korea.'}, {'ForeName': 'Hee-Ju', 'Initials': 'HJ', 'LastName': 'Kang', 'Affiliation': 'Department of Psychiatry, Chonnam National University Medical School, Gwangju, Republic of Korea.'}, {'ForeName': 'Kyung-Yeol', 'Initials': 'KY', 'LastName': 'Bae', 'Affiliation': 'Department of Psychiatry, Chonnam National University Medical School, Gwangju, Republic of Korea.'}, {'ForeName': 'Il-Seon', 'Initials': 'IS', 'LastName': 'Shin', 'Affiliation': 'Department of Psychiatry, Chonnam National University Medical School, Gwangju, Republic of Korea.'}, {'ForeName': 'Young Joon', 'Initials': 'YJ', 'LastName': 'Hong', 'Affiliation': 'Department of Cardiology, Chonnam National University Medical School, Gwangju, Republic of Korea.'}, {'ForeName': 'Young-Keun', 'Initials': 'YK', 'LastName': 'Ahn', 'Affiliation': 'Department of Cardiology, Chonnam National University Medical School, Gwangju, Republic of Korea.'}, {'ForeName': 'Myung Ho', 'Initials': 'MH', 'LastName': 'Jeong', 'Affiliation': 'Department of Cardiology, Chonnam National University Medical School, Gwangju, Republic of Korea.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Berk', 'Affiliation': 'IMPACT Strategic Research Centre, School of Medicine, Deakin University, Geelong, Australia; Department of Psychiatry, The University of Melbourne, Parkville, Australia.'}, {'ForeName': 'Jin-Sang', 'Initials': 'JS', 'LastName': 'Yoon', 'Affiliation': 'Department of Psychiatry, Chonnam National University Medical School, Gwangju, Republic of Korea.'}, {'ForeName': 'Jae-Min', 'Initials': 'JM', 'LastName': 'Kim', 'Affiliation': 'Department of Psychiatry, Chonnam National University Medical School, Gwangju, Republic of Korea. Electronic address: jmkim@chonnam.ac.kr.'}]",Progress in neuro-psychopharmacology & biological psychiatry,['10.1016/j.pnpbp.2017.07.003']
856,28711505,Practice-based research networks add value to evidence-based quality improvement.,"Background


Evidence-Based Quality Improvement (EBQI) is a systematic, multilevel approach to implementing research evidence into clinical settings. Little is known about EBQI effectiveness in the context of Practice-Based Research Networks (PBRNs), which are themselves designed to foster practice-based change. We evaluated EBQI implementation in a PBRN setting to determine the extent to which the PBRN infrastructure added value.
METHODS


We conducted a four-site cluster randomized trial of an EBQI approach to tailoring an evidence-based gender awareness curriculum in the VA Women’s Health PBRN (WH-PBRN). After curriculum implementation, site teams identified impacts of the WH-PBRN context on EBQI processes using qualitative methods, including a formal review of project call minutes, post-project debriefing calls, and structured site team input. WH-PBRN site feedback was mapped to the Replicating Effective Programs implementation phases: pre-condition, pre-implementation, implementation, and maintenance/evolution.
RESULTS


The pre-condition phase benefited from the existing WH-PBRN research-clinician relationships to facilitate stakeholder engagement and build project buy-in at local sites. During pre-implementation, differences across WH-PBRN sites offered variations in local tailoring of EBQI elements. The WH-PBRN Coordinating Center helped resolve process complexities stemming from local resource differences and the sharing of mid-project adaptations during implementation. Local efforts were amplified in the maintenance phase by WH-PBRN dissemination of findings.
Conclusions


The PBRN strengthened multi-site EBQI activities across all implementation phases.
Implications


PBRNs contribute to the uptake of evidence into everyday practice, and may serve as an important component of the future implementation of evidence-based initiatives. Level of evidence: V.",2018,"PBRNs contribute to the uptake of evidence into everyday practice, and may serve as an important component of the future implementation of evidence-based initiatives.",['VA Women’s Health PBRN (WH-PBRN'],"['EBQI approach', '\n\n\nEvidence-Based Quality Improvement (EBQI']",[],"[{'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2936612', 'cui_str': 'Quality Improvement'}]",[],,0.0607046,"PBRNs contribute to the uptake of evidence into everyday practice, and may serve as an important component of the future implementation of evidence-based initiatives.","[{'ForeName': 'Karen M', 'Initials': 'KM', 'LastName': 'Goldstein', 'Affiliation': 'VA HSR&D Center for Health Services Research in Primary Care, Durham VA Medical Center, 508 Fulton Street, Durham, NC 27705, USA; Duke University School of Medicine, Division of General Internal Medicine, USA. Electronic address: karen.goldstein@duke.edu.'}, {'ForeName': 'Dawne', 'Initials': 'D', 'LastName': 'Vogt', 'Affiliation': ""Women's Health Sciences Division, National Center for Posttraumatic Stress Disorder, VA Boston Healthcare System, Boston, MA, USA; Department of Psychiatry, Boston University School of Medicine, Boston, MA, USA.""}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Hamilton', 'Affiliation': 'VA HSR&D Center for the Study of Healthcare Innovation, Implementation & Policy, VA Greater Los Angeles Healthcare System, Los Angeles, CA, USA; Department of Psychiatry and Biobehavioral Sciences, University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Frayne', 'Affiliation': ""Center for Innovation to Implementation (Ci2i), VA Palo Alto Health Care System, Palo Alto, CA, USA; Women's Health Section, VA Palo Alto Health Care System, Palo Alto, CA, USA; Division of Primary Care and Population Health and Center for Primary Care and Outcomes Research, Stanford University, Stanford, CA, USA.""}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Gierisch', 'Affiliation': 'VA HSR&D Center for Health Services Research in Primary Care, Durham VA Medical Center, 508 Fulton Street, Durham, NC 27705, USA; Duke University School of Medicine, Division of General Internal Medicine, USA.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Blakeney', 'Affiliation': 'VA HSR&D Center for Health Services Research in Primary Care, Durham VA Medical Center, 508 Fulton Street, Durham, NC 27705, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Sadler', 'Affiliation': 'VA HSR&D Center for Comprehensive Access and Delivery Research and Evaluation, Iowa City VA Healthcare System, Iowa City, IA, USA; Department of Psychiatry, University of Iowa Carver College of Medicine, Iowa City, Iowa, USA.'}, {'ForeName': 'Bevanne M', 'Initials': 'BM', 'LastName': 'Bean-Mayberry', 'Affiliation': 'VA HSR&D Center for the Study of Healthcare Innovation, Implementation & Policy, VA Greater Los Angeles Healthcare System, Los Angeles, CA, USA; Department of Medicine, University of California Los Angeles (UCLA), USA.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Carney', 'Affiliation': 'Center for Innovation to Implementation (Ci2i), VA Palo Alto Health Care System, Palo Alto, CA, USA.'}, {'ForeName': 'Brooke', 'Initials': 'B', 'LastName': 'DiLeone', 'Affiliation': 'Center for Health Equity Research and Promotion, Philadelphia VA Medical Center, Philadelphia, PA, USA.'}, {'ForeName': 'Annie B', 'Initials': 'AB', 'LastName': 'Fox', 'Affiliation': ""Women's Health Sciences Division, National Center for Posttraumatic Stress Disorder, VA Boston Healthcare System, Boston, MA, USA.""}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Klap', 'Affiliation': 'VA HSR&D Center for the Study of Healthcare Innovation, Implementation & Policy, VA Greater Los Angeles Healthcare System, Los Angeles, CA, USA.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Yee', 'Affiliation': 'VA Medical Center-New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'Yasmin', 'Initials': 'Y', 'LastName': 'Romodan', 'Affiliation': 'Center for Innovation to Implementation (Ci2i), VA Palo Alto Health Care System, Palo Alto, CA, USA.'}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Strehlow', 'Affiliation': 'VA HSR&D Center for Comprehensive Access and Delivery Research and Evaluation, Iowa City VA Healthcare System, Iowa City, IA, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Yosef', 'Affiliation': 'VA HSR&D Center for the Study of Healthcare Innovation, Implementation & Policy, VA Greater Los Angeles Healthcare System, Los Angeles, CA, USA.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Yano', 'Affiliation': 'VA HSR&D Center for the Study of Healthcare Innovation, Implementation & Policy, VA Greater Los Angeles Healthcare System, Los Angeles, CA, USA; Department of Health Policy and Management, UCLA Fielding School of Public Health, Los Angeles, CA, USA.'}]","Healthcare (Amsterdam, Netherlands)",['10.1016/j.hjdsi.2017.06.008']
857,28115015,Early changes in gene expression and inflammatory proteins in systemic juvenile idiopathic arthritis patients on canakinumab therapy.,"BACKGROUND


Canakinumab is a human anti-interleukin-1β (IL-1β) monoclonal antibody neutralizing IL-1β-mediated pathways. We sought to characterize the molecular response to canakinumab and evaluate potential markers of response using samples from two pivotal trials in systemic juvenile idiopathic arthritis (SJIA).
METHODS


Gene expression was measured in patients with febrile SJIA and in matched healthy controls by Affymetrix DNA microarrays. Transcriptional response was assessed by gene expression changes from baseline to day 3 using adapted JIA American College of Rheumatology (aACR) response criteria (50 aACR JIA). Changes in pro-inflammatory cytokines IL-6 and IL-18 were assessed up to day 197.
RESULTS


Microarray analysis identified 984 probe sets differentially expressed (≥2-fold difference; P < 0.05) in patients versus controls. Over 50% of patients with ≥50 aACR JIA were recognizable by baseline expression values. Analysis of gene expression profiles from patients achieving ≥50 aACR JIA response at day 15 identified 102 probe sets differentially expressed upon treatment (≥2-fold difference; P < 0.05) on day 3 versus baseline, including IL-1β, IL-1 receptors (IL1-R1 and IL1-R2), IL-1 receptor accessory protein (IL1-RAP), and IL-6. The strongest clinical response was observed in patients with higher baseline expression of dysregulated genes and a strong transcriptional response on day 3. IL-6 declined by day 3 (≥8-fold decline; P < 0.0001) and remained suppressed. IL-18 declined on day 57 (≥1.5-fold decline, P ≤ 0.002).
CONCLUSIONS


Treatment with canakinumab in SJIA patients resulted in downregulation of innate immune response genes and reductions in IL-6 and clinical symptoms. Additional research is needed to investigate potential differences in the disease mechanisms in patients with heterogeneous gene transcription profiles.
TRIAL REGISTRATION


Clinicaltrials.gov: NCT00886769 (trial 1). Registered on 22 April 2009; NCT00889863 (trial 2). Registered on 21 April 2009.",2017,"IL-18 declined on day 57 (≥1.5-fold decline, P ≤ 0.002).
","['systemic juvenile idiopathic arthritis (SJIA', 'patients with heterogeneous gene transcription profiles', 'systemic juvenile idiopathic arthritis patients on canakinumab therapy', 'patients with febrile SJIA and in matched healthy controls by Affymetrix DNA microarrays']",[],"['Changes in pro-inflammatory cytokines IL-6 and IL-18', 'IL-6 and clinical symptoms', 'Transcriptional response', 'IL-18', 'IL-1β, IL-1 receptors (IL1-R1 and IL1-R2), IL-1 receptor accessory protein (IL1-RAP), and']","[{'cui': 'C1384600', 'cui_str': 'Systemic onset juvenile rheumatoid arthritis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C2718773', 'cui_str': 'canakinumab'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0332298', 'cui_str': 'Controlled by (attribute)'}, {'cui': 'C0600596', 'cui_str': 'DNA Microarrays'}]",[],"[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0383327', 'cui_str': 'Interferon-gamma-Inducing Factor'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0063710', 'cui_str': 'Receptors, IL-1'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}]",,0.109071,"IL-18 declined on day 57 (≥1.5-fold decline, P ≤ 0.002).
","[{'ForeName': 'Arndt H', 'Initials': 'AH', 'LastName': 'Brachat', 'Affiliation': 'Novartis Institutes for Biomedical Research, Basel, Switzerland.'}, {'ForeName': 'Alexei A', 'Initials': 'AA', 'LastName': 'Grom', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, PRCSG, Cincinnati, OH, USA.""}, {'ForeName': 'Nico', 'Initials': 'N', 'LastName': 'Wulffraat', 'Affiliation': 'Wilhelmina Kinderziekenhuis, Department of Pediatric Immunology and Rheumatology, Utrecht, Netherlands.'}, {'ForeName': 'Hermine I', 'Initials': 'HI', 'LastName': 'Brunner', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, PRCSG, Cincinnati, OH, USA.""}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Quartier', 'Affiliation': ""Université Paris-Descartes, IMAGINE Institute, Hôpital Necker-Enfants Malades. Centre de référence national pour les Arthrites Juveniles, Unité d'Immunologie, Hématologie et Rhumatologie Pediatrique, Paris, France.""}, {'ForeName': 'Riva', 'Initials': 'R', 'LastName': 'Brik', 'Affiliation': 'Rambam Medical Center, Department of Pediatrics B, Haifa, Israel.'}, {'ForeName': 'Liza', 'Initials': 'L', 'LastName': 'McCann', 'Affiliation': ""Alder Hey Children's NHS Foundation Trust, Liverpool, UK.""}, {'ForeName': 'Huri', 'Initials': 'H', 'LastName': 'Ozdogan', 'Affiliation': 'Cerrahpasa Tip Fakultesi, Ic Hastaliklari ABD, Romatoloji BD, Istanbul, Turkey.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Rutkowska-Sak', 'Affiliation': 'Institute of Rheumatology, Paediatric Clinic, Warsaw, Poland.'}, {'ForeName': 'Rayfel', 'Initials': 'R', 'LastName': 'Schneider', 'Affiliation': 'Hospital for Sick Children, Division of Rheumatology, Toronto, ON, Canada.'}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Gerloni', 'Affiliation': 'Istituto Gaetano Pini, Divisione di Reumatologia, Milano, Italy.'}, {'ForeName': 'Liora', 'Initials': 'L', 'LastName': 'Harel', 'Affiliation': 'Schneider Childrens Medical Center, Pediatric Rheumatology Unit, Petach-Tikvah, Israel.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Terreri', 'Affiliation': 'Universidade Federal de São Paulo, Pediatrics, São Paulo, Brazil.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Houghton', 'Affiliation': ""British Columbia Children's Hospital, Vancouver, BC, Canada.""}, {'ForeName': 'Rik', 'Initials': 'R', 'LastName': 'Joos', 'Affiliation': 'Universitair Ziekenhuis Gent, Centrum Voor Kinderreumatologie, Gent, Belgium.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Kingsbury', 'Affiliation': ""Randall Children's Hospital at Legacy Emanuel, Portland, OR, USA.""}, {'ForeName': 'Jorge M', 'Initials': 'JM', 'LastName': 'Lopez-Benitez', 'Affiliation': 'Floating Hospital for Children, Rheumatology NEMC 286, Boston, MA, USA.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Bek', 'Affiliation': 'Novartis Institutes for Biomedical Research, Basel, Switzerland.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Schumacher', 'Affiliation': 'Novartis Institutes for Biomedical Research, Basel, Switzerland.'}, {'ForeName': 'Marie-Anne', 'Initials': 'MA', 'LastName': 'Valentin', 'Affiliation': 'Novartis Institutes for Biomedical Research, Basel, Switzerland.'}, {'ForeName': 'Hermann', 'Initials': 'H', 'LastName': 'Gram', 'Affiliation': 'Novartis Institutes for Biomedical Research, Basel, Switzerland.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Abrams', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Martini', 'Affiliation': 'University of Genova and Istituto Giannina Gaslini, Pediatria II-PRINTO, Genoa, Italy.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Lovell', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, PRCSG, Cincinnati, OH, USA.""}, {'ForeName': 'Nanguneri R', 'Initials': 'NR', 'LastName': 'Nirmala', 'Affiliation': 'Novartis Institutes for Biomedical Research, Cambridge, MA, USA.'}, {'ForeName': 'Nicolino', 'Initials': 'N', 'LastName': 'Ruperto', 'Affiliation': 'Istituto Giannina Gaslini, Pediatria II-PRINTO, Genoa, Italy. nicolaruperto@gaslini.org.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Arthritis research & therapy,['10.1186/s13075-016-1212-x']
858,32412683,Costs and uptake of a community model of paediatric food allergy care versus specialist hospital care: A before-and-after controlled trial.,"AIM


To compare the costs of community-based food allergy model of care (intervention cohort, IC) with a tertiary-hospital, specialist allergy clinic model of care (control cohort, CC).
METHODS


In this pragmatic controlled trial, children (aged 0-12 years) newly referred to the allergy clinic at Melbourne's Royal Children's Hospital with suspected/known food allergy to three or fewer foods were allocated to see either a community-based paediatrician, trained via online webinars and web-based clinical decision support tools for food allergy diagnosis and management, or a hospital allergist. Per-patient costs to the health-care system and out-of-pocket costs to families seen within 12 months (clinician time, allergy tests and medicare billing) were compared between the two models of care.
RESULTS


At 12 months, 54/181 (30%) CC families had been seen in the allergy clinic and 93/115 (81%) of the IC families who chose to see a community paediatrician had been seen. In an intention-to-treat analysis (ITT), health-care system costs per IC patient were higher than the costs per CC patient (mean cost $333 versus $319, respectively; mean difference $14, 95% Confidence Interval (CI) -97 to 118, P = 0.81). Total out-of-pocket costs to family were $129 in the IC compared with $89 in the CC (mean difference $40, 95% CI $4-$77, P = 0.03).
CONCLUSIONS


A community-based model of care for simple food allergy showed that costs to the health-care system were similar between the community model and hospital care but did not show reduced out-of-pocket costs to the families 12-months post-enrolment.",2020,"In an intention-to-treat analysis (ITT), health-care system costs per IC patient were higher than the costs per CC patient (mean cost $333 versus $319, respectively; mean difference $14, 95% Confidence Interval (CI) -97 to 118, P = 0.81).","[""children (aged 0-12\u2009years) newly referred to the allergy clinic at Melbourne's Royal Children's Hospital with suspected/known food allergy to three or fewer foods"", 'paediatric food allergy care versus specialist hospital care']","['community-based paediatrician, trained via online webinars and web-based clinical decision support tools for food allergy diagnosis and management, or a hospital allergist', 'community-based food allergy model of care (intervention cohort, IC']",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C3810819', 'cui_str': 'Allergy clinic'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0016470', 'cui_str': 'Allergy to food'}, {'cui': 'C0205388', 'cui_str': 'Few'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0237433', 'cui_str': 'Pediatrician'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C4042765', 'cui_str': 'Decision Support, Clinical'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0016470', 'cui_str': 'Allergy to food'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0334896', 'cui_str': 'Clinical immunologist'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}]",[],,0.0944563,"In an intention-to-treat analysis (ITT), health-care system costs per IC patient were higher than the costs per CC patient (mean cost $333 versus $319, respectively; mean difference $14, 95% Confidence Interval (CI) -97 to 118, P = 0.81).","[{'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'Hiscock', 'Affiliation': ""Health Services Research Unit, Royal Children's Hospital, Melbourne, Victoria, Australia.""}, {'ForeName': 'Prescilla', 'Initials': 'P', 'LastName': 'Perera', 'Affiliation': ""Health Services Research Unit, Royal Children's Hospital, Melbourne, Victoria, Australia.""}, {'ForeName': 'Mimi Lk', 'Initials': 'ML', 'LastName': 'Tang', 'Affiliation': 'Department of Paediatrics, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Margaret H', 'Initials': 'MH', 'LastName': 'Danchin', 'Affiliation': 'Department of Paediatrics, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Sung', 'Affiliation': ""Centre for Community Child Health, Murdoch Children's Research Institute, Melbourne, Victoria, Australia.""}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Karnon', 'Affiliation': 'School of Public Health, University of Adelaide, Adelaide, South Australia, Australia.'}]",Journal of paediatrics and child health,['10.1111/jpc.14905']
859,31563589,A randomized pilot study of patients with tandem carotid lesions undergoing thrombectomy.,"BACKGROUND AND PURPOSE


The optimal management of patients with tandem lesions (TL), or cervical internal carotid artery (c-ICA) steno-occlusive pathology and ipsilateral intracranial occlusion, who are undergoing endovascular thrombectomy (EVT) remains unknown. We sought to establish the feasibility of a trial designed to address this question.
MATERIALS AND METHODS


The Endovascular Acute Stroke Intervention (EASI) study was a single-centre randomized trial comparing EVT to medical therapy for large-vessel occlusion stroke. Patients with TL receiving EVT were randomly allocated to acute c-ICA stenting or no stenting. The primary outcome was the proportion of patients with a modified Rankin Scale (mRS) score of 0-2 at 90 days. Safety outcomes were symptomatic intracranial hemorrhage (sICH) at 24hours and mortality at 90 days.
RESULTS


Of 301 patients included in EASI between 2013 and 2018, 24 (8.0%) with TL were randomly allocated to acute stenting (n=13) or no stenting (n=11). Baseline characteristics were balanced. Eight (61.5%; 95% CI 35.5%-82.3%) and 7 (63.6%; 95% CI 35.4%-84.9%) patients, respectively, had a favorable outcome (mRS 0-2; P=1.0). One non-stented patient had a symptomatic intracerebral hemorrhage.
CONCLUSIONS


This pilot trial of patients with TL undergoing EVT suggests that a sufficiently powered larger TL trial comparing acute c-ICA stenting to no stenting is feasible.
CLINICAL TRIAL REGISTRATION


URL: http://www.clinicaltrials.gov. Unique identifier: NCT02157532.",2020,The Endovascular Acute Stroke Intervention (EASI) study was a single-centre randomized trial comparing EVT to medical therapy for large-vessel occlusion stroke.,"['Patients with TL receiving EVT', 'large-vessel occlusion stroke', 'patients with TL undergoing EVT suggests that a sufficiently powered larger TL trial comparing acute c', 'patients with tandem carotid lesions\xa0undergoing thrombectomy', 'patients with tandem lesions (TL), or cervical internal carotid artery (c-ICA) steno-occlusive pathology and ipsilateral intracranial occlusion, who are undergoing endovascular thrombectomy (EVT) remains unknown', '301 patients included in EASI between 2013 and 2018, 24 (8.0%) with TL']","['EVT', 'no stenting', 'acute stenting', 'acute c-ICA stenting or no stenting', 'ICA stenting to no stenting']","['symptomatic intracerebral hemorrhage', 'proportion of patients with a modified Rankin Scale (mRS) score', 'symptomatic intracranial hemorrhage (sICH) at 24hours and mortality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0225990', 'cui_str': 'Large vessel'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0075804', 'cui_str': 'TANDEM'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0162578', 'cui_str': 'Thrombectomy'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C0007276', 'cui_str': 'Carotid Artery, Internal'}, {'cui': 'C0201519', 'cui_str': 'Antibody to islet cells of pancreas measurement (procedure)'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral (qualifier value)'}, {'cui': 'C0524466', 'cui_str': 'Intracranial (qualifier value)'}, {'cui': 'C0439673', 'cui_str': 'Unknown (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0201519', 'cui_str': 'Antibody to islet cells of pancreas measurement (procedure)'}]","[{'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C2937358', 'cui_str': 'Intracerebral Hemorrhage'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0151699', 'cui_str': 'Intracranial Hemorrhage'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",301.0,0.219985,The Endovascular Acute Stroke Intervention (EASI) study was a single-centre randomized trial comparing EVT to medical therapy for large-vessel occlusion stroke.,"[{'ForeName': 'Alexandre Y', 'Initials': 'AY', 'LastName': 'Poppe', 'Affiliation': ""Division of Neurology, Centre Hospitalier de l'Université de Montréal, 900, rue St-Denis, R04-758 H2X 0A9 Montréal, Québec, Canada; Neurovascular Group, Axe Neurosciences, Centre de Recherche du Centre Hospitalier de l'Université de Montréal, 900, rue St-Denis, R04-758 H2X 0A9 Montréal, Québec, Canada; Department of Neurosciences, Faculté de Médecine, Université de Montréal, 900, rue St-Denis, R04-758 H2X 0A9 Montréal, Québec, Canada. Electronic address: alexandre.poppe.chum@ssss.gouv.qc.ca.""}, {'ForeName': 'Grégory', 'Initials': 'G', 'LastName': 'Jacquin', 'Affiliation': ""Division of Neurology, Centre Hospitalier de l'Université de Montréal, 900, rue St-Denis, R04-758 H2X 0A9 Montréal, Québec, Canada; Neurovascular Group, Axe Neurosciences, Centre de Recherche du Centre Hospitalier de l'Université de Montréal, 900, rue St-Denis, R04-758 H2X 0A9 Montréal, Québec, Canada; Department of Neurosciences, Faculté de Médecine, Université de Montréal, 900, rue St-Denis, R04-758 H2X 0A9 Montréal, Québec, Canada.""}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Stapf', 'Affiliation': ""Division of Neurology, Centre Hospitalier de l'Université de Montréal, 900, rue St-Denis, R04-758 H2X 0A9 Montréal, Québec, Canada; Neurovascular Group, Axe Neurosciences, Centre de Recherche du Centre Hospitalier de l'Université de Montréal, 900, rue St-Denis, R04-758 H2X 0A9 Montréal, Québec, Canada; Department of Neurosciences, Faculté de Médecine, Université de Montréal, 900, rue St-Denis, R04-758 H2X 0A9 Montréal, Québec, Canada.""}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Daneault', 'Affiliation': ""Division of Neurology, Centre Hospitalier de l'Université de Montréal, 900, rue St-Denis, R04-758 H2X 0A9 Montréal, Québec, Canada; Neurovascular Group, Axe Neurosciences, Centre de Recherche du Centre Hospitalier de l'Université de Montréal, 900, rue St-Denis, R04-758 H2X 0A9 Montréal, Québec, Canada; Department of Neurosciences, Faculté de Médecine, Université de Montréal, 900, rue St-Denis, R04-758 H2X 0A9 Montréal, Québec, Canada.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Deschaintre', 'Affiliation': ""Division of Neurology, Centre Hospitalier de l'Université de Montréal, 900, rue St-Denis, R04-758 H2X 0A9 Montréal, Québec, Canada; Neurovascular Group, Axe Neurosciences, Centre de Recherche du Centre Hospitalier de l'Université de Montréal, 900, rue St-Denis, R04-758 H2X 0A9 Montréal, Québec, Canada; Department of Neurosciences, Faculté de Médecine, Université de Montréal, 900, rue St-Denis, R04-758 H2X 0A9 Montréal, Québec, Canada.""}, {'ForeName': 'Laura C', 'Initials': 'LC', 'LastName': 'Gioia', 'Affiliation': ""Division of Neurology, Centre Hospitalier de l'Université de Montréal, 900, rue St-Denis, R04-758 H2X 0A9 Montréal, Québec, Canada; Neurovascular Group, Axe Neurosciences, Centre de Recherche du Centre Hospitalier de l'Université de Montréal, 900, rue St-Denis, R04-758 H2X 0A9 Montréal, Québec, Canada; Department of Neurosciences, Faculté de Médecine, Université de Montréal, 900, rue St-Denis, R04-758 H2X 0A9 Montréal, Québec, Canada.""}, {'ForeName': 'Céline', 'Initials': 'C', 'LastName': 'Odier', 'Affiliation': ""Division of Neurology, Centre Hospitalier de l'Université de Montréal, 900, rue St-Denis, R04-758 H2X 0A9 Montréal, Québec, Canada; Neurovascular Group, Axe Neurosciences, Centre de Recherche du Centre Hospitalier de l'Université de Montréal, 900, rue St-Denis, R04-758 H2X 0A9 Montréal, Québec, Canada; Department of Neurosciences, Faculté de Médecine, Université de Montréal, 900, rue St-Denis, R04-758 H2X 0A9 Montréal, Québec, Canada.""}, {'ForeName': 'Marilyn', 'Initials': 'M', 'LastName': 'Labrie', 'Affiliation': ""Division of Neurology, Centre Hospitalier de l'Université de Montréal, 900, rue St-Denis, R04-758 H2X 0A9 Montréal, Québec, Canada.""}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Nehme', 'Affiliation': ""Division of Neurology, Centre Hospitalier de l'Université de Montréal, 900, rue St-Denis, R04-758 H2X 0A9 Montréal, Québec, Canada.""}, {'ForeName': 'Lorena', 'Initials': 'L', 'LastName': 'Nico', 'Affiliation': ""Department of Radiology, Centre Hospitalier de l'Université de Montréal, 900, rue St-Denis, R04-758 H2X 0A9 Montréal, Québec, Canada.""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Roy', 'Affiliation': ""Department of Radiology, Centre Hospitalier de l'Université de Montréal, 900, rue St-Denis, R04-758 H2X 0A9 Montréal, Québec, Canada; Neurovascular Group, Axe Neurosciences, Centre de Recherche du Centre Hospitalier de l'Université de Montréal, 900, rue St-Denis, R04-758 H2X 0A9 Montréal, Québec, Canada.""}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Weill', 'Affiliation': ""Department of Radiology, Centre Hospitalier de l'Université de Montréal, 900, rue St-Denis, R04-758 H2X 0A9 Montréal, Québec, Canada; Neurovascular Group, Axe Neurosciences, Centre de Recherche du Centre Hospitalier de l'Université de Montréal, 900, rue St-Denis, R04-758 H2X 0A9 Montréal, Québec, Canada.""}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Raymond', 'Affiliation': ""Department of Radiology, Centre Hospitalier de l'Université de Montréal, 900, rue St-Denis, R04-758 H2X 0A9 Montréal, Québec, Canada; Neurovascular Group, Axe Neurosciences, Centre de Recherche du Centre Hospitalier de l'Université de Montréal, 900, rue St-Denis, R04-758 H2X 0A9 Montréal, Québec, Canada.""}]",Journal of neuroradiology = Journal de neuroradiologie,['10.1016/j.neurad.2019.08.003']
860,28448174,"A School-Based, Peer-Led, Social Marketing Intervention To Engage Spanish Adolescents in a Healthy Lifestyle (""We Are Cool""-Som la Pera Study): A Parallel-Cluster Randomized Controlled Study.","BACKGROUND


Encouraging adolescents to adopt healthy lifestyles can be challenging. The aim of the ""Som la Pera"" study was to engage adolescents by applying new strategies to increase both their fruit and vegetable consumption and their physical activity (PA) while reducing their sedentary behavior.
METHODS


In disadvantaged neighborhoods of Reus (Spain), two high schools were randomly assigned to the intervention (n = 170 adolescents 13- to 16-year-olds) and two were assigned to the control group (n = 223 adolescents 13- to 16-year-olds). The intervention, which lasted 12 months and spanned 2 academic years (2013-2015), used social marketing (SM) to improve healthy choices. The peer-led strategy involved 5 adolescents who designed and implemented 10 activities as challenges for their 165 school-aged peers. The control group received no intervention. To assess self-reported lifestyles in both groups, the Health Behavior in School-Aged Children Survey was used at baseline and end of study.
RESULTS


After 12 months, intervention adolescents showed an increase of 28.9% in ≥1 fruit/day (p < 0.01) and of 18.5% in ≥6 hours/week of PA (p < 0.01) compared with controls. Additionally, intervention group males had an increase of 28.8% in ≥1 vegetable/day (p < 0.01) and of 15.6% in ≤2 hours/day of sedentary activity (p = 0.01) compared with controls.
CONCLUSIONS


A school-based, peer-led, SM intervention developed by adolescents attending high schools in low-income neighborhoods effectively improved the healthy choices of their school-aged peers, leading to increased fruit consumption and PA in adolescents of both genders. Furthermore, adolescent males were more sensitive to improvements in healthy choices, showing increased vegetable consumption and decreased sedentary behavior.",2017,"Additionally, intervention group males had an increase of 28.8% in ≥1 vegetable/day (p < 0.01) and of 15.6% in ≤2 hours/day of sedentary activity (p = 0.01) compared with controls.
","['adolescent males', 'disadvantaged neighborhoods of Reus (Spain), two high schools were randomly assigned to the intervention (n\u2009=\u2009170 adolescents 13- to 16-year-olds) and two were assigned to the control group (n\u2009=\u2009223 adolescents 13- to 16-year-olds', '5 adolescents who designed and implemented 10 activities as challenges for their 165 school-aged peers', 'adolescents attending high schools in low-income neighborhoods']","['social marketing (SM', 'no intervention', 'Social Marketing Intervention']","['sedentary activity', 'vegetable consumption and decreased sedentary behavior']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0027569', 'cui_str': 'Neighborhood'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C4517599', 'cui_str': 'One hundred and seventy'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0302604', 'cui_str': 'Low income'}]","[{'cui': 'C0037424', 'cui_str': 'Social Marketing'}]","[{'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C1532253', 'cui_str': 'Sedentary Behavior'}]",5.0,0.0257562,"Additionally, intervention group males had an increase of 28.8% in ≥1 vegetable/day (p < 0.01) and of 15.6% in ≤2 hours/day of sedentary activity (p = 0.01) compared with controls.
","[{'ForeName': 'Magaly', 'Initials': 'M', 'LastName': 'Aceves-Martins', 'Affiliation': '1 Health Education and Promotion, Facultat de Medicina i Ciències de la Salut, Universitat Rovira i Virgili , Reus, Spain .'}, {'ForeName': 'Elisabet', 'Initials': 'E', 'LastName': 'Llauradó', 'Affiliation': '1 Health Education and Promotion, Facultat de Medicina i Ciències de la Salut, Universitat Rovira i Virgili , Reus, Spain .'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Tarro', 'Affiliation': '1 Health Education and Promotion, Facultat de Medicina i Ciències de la Salut, Universitat Rovira i Virgili , Reus, Spain .'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Moriña', 'Affiliation': ""3 Unit of Infections and Cancer (UNIC), Cancer Epidemiology Research Program (CERP), Catalan Institute of Oncology (ICO)-IDIBELL , L'Hospitalet de Llobregat, Barcelona, Spain .""}, {'ForeName': 'Ignasi', 'Initials': 'I', 'LastName': 'Papell-Garcia', 'Affiliation': '4 Eurecat, Technology Centre of Catalonia , Reus, Spain .'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Prades-Tena', 'Affiliation': ""5 Departament d'Estudis de Comunicació, Universitat Rovira i Virgili , Tarragona, Spain .""}, {'ForeName': 'Helle', 'Initials': 'H', 'LastName': 'Kettner-Høeberg', 'Affiliation': ""5 Departament d'Estudis de Comunicació, Universitat Rovira i Virgili , Tarragona, Spain .""}, {'ForeName': 'Francesc', 'Initials': 'F', 'LastName': 'Puiggròs', 'Affiliation': '4 Eurecat, Technology Centre of Catalonia , Reus, Spain .'}, {'ForeName': 'Lluís', 'Initials': 'L', 'LastName': 'Arola', 'Affiliation': '4 Eurecat, Technology Centre of Catalonia , Reus, Spain .'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Davies', 'Affiliation': ""7 Health & Social Care, National Children's Bureau , London, United Kingdom .""}, {'ForeName': 'Montse', 'Initials': 'M', 'LastName': 'Giralt', 'Affiliation': '1 Health Education and Promotion, Facultat de Medicina i Ciències de la Salut, Universitat Rovira i Virgili , Reus, Spain .'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Solà', 'Affiliation': '1 Health Education and Promotion, Facultat de Medicina i Ciències de la Salut, Universitat Rovira i Virgili , Reus, Spain .'}]",Childhood obesity (Print),['10.1089/chi.2016.0216']
861,31582549,"Long-term outcome of a randomized controlled study in patients with newly diagnosed severe aplastic anemia treated with antithymocyte globulin and cyclosporine, with or without granulocyte colony-stimulating factor: a Severe Aplastic Anemia Working Party Trial from the European Group of Blood and Marrow Transplantation.","This follow-up study of a randomized, prospective trial included 192 patients with newly diagnosed severe aplastic anemia receiving antithymoglobulin and cyclosporine, with or without granulocyte colony-stimulating factor (G-CSF). We aimed to evaluate the long-term effect of G-CSF on overall survival, event-free survival, probability of secondary myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML), clinical paroxysmal nocturnal hemoglobinuria, relapse, avascular osteonecrosis and chronic kidney disease. The median follow-up was 11.7 years (95% CI, 10.9-12.5). The overall survival rate at 15 years was 57±12% in the group given G-CSF and 63±12% in the group not given G-CSF ( P =0.92); the corresponding event-free survival rates were 24±10% and 23±10%, respectively ( P =0.36). In total, 9 patients developed MDS or AML, 10 only a clonal cytogenetic abnormality, 7 a solid cancer, 18 clinical paroxysmal nocturnal hemoglobinuria, 8 osteonecrosis, and 12 chronic kidney disease, without any difference between patients treated with or without G-CSF. The cumulative incidence of MDS, AML or isolated cytogenetic abnormality at 15 years was 8.5±3% for the G-CSF group and 8.2±3% for the non-G-CSF group ( P =0.90). The cumulative incidence of any late event including myelodysplastic syndrome or acute myeloid leukemia, isolated cytogenetic abnormalities, solid cancer, clinical paroxysmal nocturnal hemoglobinuria, aseptic osteonecrosis, chronic kidney disease and relapse was 50±12% for the G-CSF group and 49±12% for the non-G-CSF group ( P =0.65). Our results demonstrate that it is unlikely that G-CSF has an impact on the outcome of severe aplastic anemia; nevertheless, very late events are common and eventually affect the prognosis of these patients, irrespectively of their age at the time of immunosuppressive therapy (NCT01163942).",2020,"Overall survival at 15 years was 57±12% for the G-CSF and 63±12% for the non-G-CSF group (P=0.92), event-free survival 24±10% for the G-CSF, and 23±10% for the non-G-CSF group (P=0.36).","['192 patients with newly diagnosed severe aplastic anemia receiving Antithymoglobulin and Cyclosporine, with and without G-CSF', 'patients with newly diagnosed severe aplastic anemia treated with']","['G-CSF', 'antithymocyte globuline, cyclosporine, with or without G-CSF']","['Cumulative incidence', 'myelodysplastic syndrome or acute myeloid leukemia', 'Cumulative incidence of any late event including myelodysplastic syndrome or acute myeloid leukemia , isolated cytogenetic abnormalities, solid cancer, clinical paroxysmal nocturnal hemoglobinuria, aseptic osteonecrosis, chronic kidney disease and relapse', 'myelodysplastic syndrome, acute myeloid leukemia or isolated cytogenetic abnormality', 'severe aplastic anemia', 'Overall survival', 'overall survival, event-free survival, probability of secondary myelodysplastic syndrome or acute myeloid leukemia, clinical paroxysmal nocturnal hemoglobinuria, relapse, avascular osteonecrosis and chronic kidney disease']","[{'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0002874', 'cui_str': 'Aplastic Anemia'}, {'cui': 'C0003442', 'cui_str': 'Lymphocyte Immune Globulin, Anti-Thymocyte Globulin'}, {'cui': 'C0010594', 'cui_str': 'Cyclosporins'}, {'cui': 'C0079459', 'cui_str': 'G-CSF'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0079459', 'cui_str': 'G-CSF'}, {'cui': 'C0010594', 'cui_str': 'Cyclosporins'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C3666007', 'cui_str': 'Myelodysplastic syndrome (SMQ)'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205409', 'cui_str': 'Isolated (qualifier value)'}, {'cui': 'C0008625', 'cui_str': 'Abnormalities, Chromosome'}, {'cui': 'C0302909', 'cui_str': 'Solid substance (substance)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0024790', 'cui_str': 'Marchiafava-Micheli Syndrome'}, {'cui': 'C0232920', 'cui_str': 'Sterile (qualifier value)'}, {'cui': 'C0029445', 'cui_str': 'Osteonecrosis'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0002874', 'cui_str': 'Aplastic Anemia'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}]",192.0,0.0456951,"Overall survival at 15 years was 57±12% for the G-CSF and 63±12% for the non-G-CSF group (P=0.92), event-free survival 24±10% for the G-CSF, and 23±10% for the non-G-CSF group (P=0.36).","[{'ForeName': 'André', 'Initials': 'A', 'LastName': 'Tichelli', 'Affiliation': 'Division of Hematology, University Hospital Basel, Basel, Switzerland tichelli@datacomm.ch.'}, {'ForeName': 'Régis Peffault', 'Initials': 'RP', 'LastName': 'de Latour', 'Affiliation': 'Université de Paris, and Hematology-Transplantation, Saint Louis Hospital (AP-HP), Paris, France.'}, {'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Passweg', 'Affiliation': 'Division of Hematology, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Cora', 'Initials': 'C', 'LastName': 'Knol-Bout', 'Affiliation': 'EBMT Registry Office, Leiden, the Netherlands.'}, {'ForeName': 'Gérard', 'Initials': 'G', 'LastName': 'Socié', 'Affiliation': 'Université de Paris, INSERM U976 and Hematology-Transplantation, Saint Louis Hospital (AP-HP), Paris, France.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Marsh', 'Affiliation': ""Department of Haematological Medicine, King's College Hospital/King's College London, London, UK.""}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Schrezenmeier', 'Affiliation': 'Institute of Tranfusion Medicine, University of Ulm and Institute of Clinical Transfusion Medicine and Immunogenetics Ulm, German Red Cross Blood Transfusion Service Baden-Württemberg-Hessen and University Hospital Ulm, Ulm, Germany.'}, {'ForeName': 'Britta', 'Initials': 'B', 'LastName': 'Höchsmann', 'Affiliation': 'Institute of Tranfusion Medicine, University of Ulm and Institute of Clinical Transfusion Medicine and Immunogenetics Ulm, German Red Cross Blood Transfusion Service Baden-Württemberg-Hessen and University Hospital Ulm, Ulm, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Bacigalupo', 'Affiliation': 'Instituto di Ematologia, Fondazione Policlinico Universitario Gemelli IRCSS, Università Cattolica del Sacro Cuore, Roma, Italy.'}, {'ForeName': 'Sujith', 'Initials': 'S', 'LastName': 'Samarasinghe', 'Affiliation': 'Sujith Samarasinghe, Great Ormond Street Hospital, London, UK.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Rovó', 'Affiliation': 'Department of Hematology and Central Hematology Laboratory, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Austin', 'Initials': 'A', 'LastName': 'Kulasekararaj', 'Affiliation': ""Department of Haematological Medicine, King's College Hospital, NIHR/Wellcome King's Clinical Research Facility, London, UK.""}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Röth', 'Affiliation': 'Department of Hematology, West German Cancer Center, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Dirk-Jan', 'Initials': 'DJ', 'LastName': 'Eikema', 'Affiliation': 'EBMT Registry Office, Leiden, the Netherlands.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Bosman', 'Affiliation': 'EBMT Registry Office, Leiden, the Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bader', 'Affiliation': ""University Children's Hospital Frankfurt, Frankfurt, Germany.""}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Risitano', 'Affiliation': 'Hematology Department of Clinical Medicine and Surgery, Federico II University of Naples, Naples, Italy.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Dufour', 'Affiliation': ""Hemato-Onco-SCT Pole, Hematology Unit. G. Gaslini Children's Research Hospital, Genova, Italy.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Haematologica,['10.3324/haematol.2019.222562']
862,28019686,"Dietary Inflammatory Index, Bone Mineral Density, and Risk of Fracture in Postmenopausal Women: Results From the Women's Health Initiative.","Previous studies suggest that bone loss and fracture risk are associated with higher inflammatory milieu, potentially modifiable by diet. The primary objective of this analysis was to evaluate the association of the dietary inflammatory index (DII), a measure of the inflammatory potential of diet, with risk of hip, lower-arm, and total fracture using longitudinal data from the Women's Health Initiative Observational Study and Clinical Trials. Secondarily, we evaluated changes in bone mineral density (BMD) and DII scores. DII scores were calculated from baseline food frequency questionnaires (FFQs) completed by 160,191 participants (mean age 63 years) without history of hip fracture at enrollment. Year 3 FFQs were used to calculate a DII change score. Fractures were reported at least annually; hip fractures were confirmed by medical records. Hazard ratios for fractures were computed using multivariable-adjusted Cox proportional hazard models, further stratified by age and race/ethnicity. Pairwise comparisons of changes in hip BMD, measured by dual-energy X-ray absorptiometry from baseline, year 3, and year 6 were analyzed by quartile (Q1 = least inflammatory diet) of baseline DII scores in a subgroup of women (n = 10,290). Mean DII score improved significantly over 3 years (p < 0.01), but change was not associated with fracture risk. Baseline DII score was only associated with hip fracture risk in younger white women (HR Q4,1.48; 95% CI, 1.09 to 2.01; p = 0.01). There were no significant associations among white women older than 63 years or other races/ethnicities. Women with the least inflammatory DII scores had less loss of hip BMD (p = 0.01) by year 6, despite lower baseline hip BMD, versus women with the most inflammatory DII scores. In conclusion, a less inflammatory dietary pattern was associated with less BMD loss in postmenopausal women. A more inflammatory diet was associated with increased hip fracture risk only in white women younger than 63 years. © 2016 American Society for Bone and Mineral Research.",2017,"Women with the least inflammatory DII scores had less loss of hip BMD (p = 0.01) by year 6, despite lower baseline hip BMD, versus women with the most inflammatory DII scores.","['postmenopausal women', 'white women older than 63 years or other races/ethnicities', '160,191 participants (mean age 63 years) without history of hip fracture at enrollment', 'Postmenopausal Women', '© 2016 American Society for Bone and Mineral Research']",[],"['Baseline DII score', 'Mean DII score', 'dietary inflammatory index (DII', 'bone mineral density (BMD) and DII scores', 'BMD loss', 'loss of hip BMD', 'DII scores', 'hip fracture risk', 'Dietary Inflammatory Index, Bone Mineral Density, and Risk of Fracture']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0243103', 'cui_str': 'ethnicity'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1272069', 'cui_str': 'H/O: hip fracture'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0026162', 'cui_str': 'Minerals'}, {'cui': 'C0035168'}]",[],"[{'cui': 'C0385506', 'cui_str': 'didodecylindocarbocyanine'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0019557', 'cui_str': 'Hip Fractures'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}]",,0.0692221,"Women with the least inflammatory DII scores had less loss of hip BMD (p = 0.01) by year 6, despite lower baseline hip BMD, versus women with the most inflammatory DII scores.","[{'ForeName': 'Tonya', 'Initials': 'T', 'LastName': 'Orchard', 'Affiliation': 'Department of Human Sciences, Human Nutrition Program, The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Vedat', 'Initials': 'V', 'LastName': 'Yildiz', 'Affiliation': ""Women's Health Initiative Midwest Regional Center for Biostatistics, The Ohio State University, Columbus, OH, USA.""}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Steck', 'Affiliation': 'Cancer Prevention and Control Program and Department of Epidemiology and Biostatistics, University of South Carolina, Columbia, SC, USA.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Hébert', 'Affiliation': 'Cancer Prevention and Control Program and Department of Epidemiology and Biostatistics, University of South Carolina, Columbia, SC, USA.'}, {'ForeName': 'Yunsheng', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': 'Division of Preventive and Behavioral Medicine, Department of Medicine, University of Massachusetts Medical School, Worcester, MA, USA.'}, {'ForeName': 'Jane A', 'Initials': 'JA', 'LastName': 'Cauley', 'Affiliation': 'Graduate School of Public Health, Department of Epidemiology, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Wenjun', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Health Statistics and Geography Lab, Division of Preventive and Behavioral Medicine, Department of Medicine, University of Massachusetts Medical School, Worcester, MA, USA.'}, {'ForeName': 'Yasmin', 'Initials': 'Y', 'LastName': 'Mossavar-Rahmani', 'Affiliation': 'Department of Epidemiology & Population Health, Albert Einstein College of Medicine, Bronx, NY, USA.'}, {'ForeName': 'Karen C', 'Initials': 'KC', 'LastName': 'Johnson', 'Affiliation': 'Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, TN, USA.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Sattari', 'Affiliation': 'College of Medicine, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Meryl', 'Initials': 'M', 'LastName': 'LeBoff', 'Affiliation': 'Harvard Medical School, Harvard University, Boston, MA, USA.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Wactawski-Wende', 'Affiliation': 'Department of Epidemiology and Environmental Health, School of Public Health and Health Professions, University at Buffalo, Buffalo, NY, USA.'}, {'ForeName': 'Rebecca D', 'Initials': 'RD', 'LastName': 'Jackson', 'Affiliation': 'Department of Internal Medicine, College of Medicine, The Ohio State University, Columbus, OH, USA.'}]",Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research,['10.1002/jbmr.3070']
863,31575299,Cognitive behavioural therapy significantly reduces anxiety in patients with implanted cardioverter defibrillator compared with usual care: Findings from the Screen-ICD randomised controlled trial.,"AIM


The aim of this study was to investigate the effect of a cognitive behavioural therapy intervention provided by trained cardiac nurses plus usual care compared with usual care alone in patients with an implanted cardioverter defibrillator who, prior to randomization, had presented with symptoms of anxiety measured by the Hospital Anxiety and Depression Scale.
BACKGROUND


Around 20-25% of all patients with an implanted cardioverter defibrillator experience anxiety. Among these patients anxiety is associated with mortality, presumably explained by risk behaviour and activation of the autonomic nervous system. We hypothesised that cognitive behavioural therapy provided by cardiac nurses in an out-patient setting would be an effective treatment of anxiety.
METHODS


This was an investigator-initiated randomised clinical superiority trial with blinded outcome assessment, with 1:1 randomisation to cognitive behavioural therapy plus usual care or to usual care. The primary outcome was Hospital Anxiety and Depression Scale-Anxiety mean score at 16 weeks. Secondary outcomes included Hospital Anxiety and Depression Scale-Depression, Becks Anxiety Inventory, HeartQoL and Hamilton Anxiety Scale. Primary outcome analysis was based on the intention-to-treat principle.
RESULTS


A total of 88 participants were included, 66% men, mean age 64.3 years and 61% had primary indication implantable cardioverter defibrillator. A significant difference after 16 weeks was found between groups: intervention group (Hospital Anxiety and Depression Scale-A mean (standard deviation) 4.95 points (3.30) versus usual care group 8.98 points (4.03) ( p  < 0.0001)). Cohen's d was -0.86, indicating a strong clinical effect. The effect was supported by secondary outcomes.
CONCLUSION


Cognitive behavioural therapy provided by cardiac nurses to patients with a positive screening for anxiety had a statistically and clinically significant effect on anxiety compared with patients not receiving cognitive behavioural therapy.",2020,A significant difference after 16 weeks was found between groups: intervention group (Hospital Anxiety and Depression Scale-A mean (standard deviation) 4.95 points (3.30) versus usual care group 8.98 points (4.03) ( p  < 0.0001)).,"['patients with an implanted cardioverter defibrillator who, prior to randomization, had presented with symptoms of anxiety measured by the Hospital Anxiety and Depression Scale.\nBACKGROUND\n\n\nAround 20-25% of all patients with an implanted cardioverter defibrillator experience anxiety', 'patients with implanted', 'A total of 88 participants were included, 66% men, mean age 64.3 years and 61% had primary indication implantable cardioverter defibrillator']","['cardioverter defibrillator', 'cognitive behavioural therapy', 'cognitive behavioural therapy intervention', 'usual care alone', 'cognitive behavioural therapy plus usual care or to usual care', 'Cognitive behavioural therapy']","['Hospital Anxiety and Depression Scale-Depression, Becks Anxiety Inventory, HeartQoL and Hamilton Anxiety Scale', 'intention-to-treat principle', 'anxiety', 'Hospital Anxiety and Depression Scale-A mean', 'Hospital Anxiety and Depression Scale-Anxiety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0180307', 'cui_str': 'Defibrillators'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0162589', 'cui_str': 'Implantable Cardioverter-Defibrillators'}]","[{'cui': 'C0180307', 'cui_str': 'Defibrillators'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0582613', 'cui_str': 'Beck anxiety inventory (assessment scale)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0222045'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",88.0,0.110186,A significant difference after 16 weeks was found between groups: intervention group (Hospital Anxiety and Depression Scale-A mean (standard deviation) 4.95 points (3.30) versus usual care group 8.98 points (4.03) ( p  < 0.0001)).,"[{'ForeName': 'Selina K', 'Initials': 'SK', 'LastName': 'Berg', 'Affiliation': 'Centre for Cardiac, Vascular, Pulmonary and Infectious Diseases, Copenhagen University Hospital, Denmark.'}, {'ForeName': 'Trine B', 'Initials': 'TB', 'LastName': 'Rasmussen', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital, Denmark.'}, {'ForeName': 'Margrethe', 'Initials': 'M', 'LastName': 'Herning', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital, Denmark.'}, {'ForeName': 'Jesper H', 'Initials': 'JH', 'LastName': 'Svendsen', 'Affiliation': 'Centre for Cardiac, Vascular, Pulmonary and Infectious Diseases, Copenhagen University Hospital, Denmark.'}, {'ForeName': 'Anne V', 'Initials': 'AV', 'LastName': 'Christensen', 'Affiliation': 'Centre for Cardiac, Vascular, Pulmonary and Infectious Diseases, Copenhagen University Hospital, Denmark.'}, {'ForeName': 'Lau C', 'Initials': 'LC', 'LastName': 'Thygesen', 'Affiliation': 'National Institute of Public Health, University of Southern Denmark, Denmark.'}]",European journal of preventive cardiology,['10.1177/2047487319874147']
864,32412629,The Intervention Nurses Start Infants Growing on Healthy Trajectories (INSIGHT) Responsive Parenting Intervention for Firstborns Affects Dietary Intake of Secondborn Infants.,"BACKGROUND


Although previous work has shown that children with older siblings tend to have poorer diet quality, no study has directly compared diets of infant siblings.
OBJECTIVE


The goals of this analysis were to examine birth-order differences in dietary intake between firstborn (FB) and secondborn (SB) siblings, and to determine whether a responsive parenting (RP) intervention modified birth-order effects on diet.
METHODS


The Intervention Nurses Start Infants Growing on Healthy Trajectories (INSIGHT) study randomly assigned first-time mothers to an RP intervention, which included guidance on feeding, sleep, soothing, and interactive play, or control. INSIGHT mothers who delivered a second child enrolled in an observation-only study of their SB infant (SIBSIGHT). Mothers completed FFQs for both children at ages 6 (n = 97 sibling pairs) and 12 (n = 100) mo. FB compared with SB intake of food groups of interest were compared, and the moderating effect of the RP intervention on birth-order differences was tested using generalized linear mixed models.
RESULTS


Though FBs and SBs had similar diets, more FBs than SBs consumed 100% fruit juice at both 6 (13.8 compared with 3.2%, P = 0.006) and 12 mo (46.0 compared with 32.0%, P = 0.01). SBs consumed fruit more frequently (FB 2.8 compared with SB 3.2 times/d, P = 0.01), and were more likely to consume fried potatoes (FB 38.4 compared with SB 57.6%, P = 0.0009) and processed meats (FB 43.0 compared with SB 58.0%, P = 0.02) than FBs at 12 mo. There were no differences by birth order in intake of sweets, snacks, or sugar-sweetened beverages at 12 mo. At 12 mo, RP-group SBs ate vegetables more times per day (3.2) than control SBs (2.2, P = 0.01). RP-SBs also consumed a greater variety of vegetables (10.2) than control-SBs (7.9, P = 0.01).
CONCLUSIONS


Birth order is not consistently associated with healthy or unhealthy infant dietary intake. However, an RP intervention delivered to first-time mothers may benefit subsequent infants' vegetable intake. This trial was registered at clinicaltrials.gov as NCT01167270.",2020,"SBs consumed fruit more frequently (FB 2.8 compared with SB 3.2 times/d, P = 0.01), and were more likely to consume fried potatoes (FB 38.4 compared with SB 57.6%, P = 0.0009) and processed meats (FB 43.0 compared with SB 58.0%, P = 0.02) than FBs at 12 mo.","['Secondborn Infants', 'INSIGHT mothers who delivered a second child enrolled in an observation-only study of their SB infant (SIBSIGHT', 'children with older siblings', 'The Intervention Nurses Start Infants']","['RP intervention', 'RP intervention, which included guidance on feeding, sleep, soothing, and interactive play, or control', 'Intervention Nurses Start Infants Growing on Healthy Trajectories (INSIGHT']","['birth order in intake of sweets, snacks, or sugar-sweetened beverages']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0337511', 'cui_str': 'Older sibling'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0439659', 'cui_str': 'Origins'}]","[{'cui': 'C0205342', 'cui_str': 'Responsive'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0005607', 'cui_str': 'Place in family order'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0085077', 'cui_str': 'Acute febrile neutrophilic dermatosis'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C5197754', 'cui_str': 'Sugar-Added Beverages'}]",,0.0545827,"SBs consumed fruit more frequently (FB 2.8 compared with SB 3.2 times/d, P = 0.01), and were more likely to consume fried potatoes (FB 38.4 compared with SB 57.6%, P = 0.0009) and processed meats (FB 43.0 compared with SB 58.0%, P = 0.02) than FBs at 12 mo.","[{'ForeName': 'Emily E', 'Initials': 'EE', 'LastName': 'Hohman', 'Affiliation': 'Center for Childhood Obesity Research, Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Savage', 'Affiliation': 'Center for Childhood Obesity Research, Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Leann L', 'Initials': 'LL', 'LastName': 'Birch', 'Affiliation': 'Department of Foods and Nutrition, University of Georgia, Athens, GA, USA.'}, {'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Paul', 'Affiliation': 'Departments of Pediatrics and Public Health Sciences, Penn State College of Medicine, Hershey, PA, USA.'}]",The Journal of nutrition,['10.1093/jn/nxaa135']
865,31368908,"Comparison of Effectiveness of Etoricoxib and Diclofenac on Pain and Perioperative Sequelae After Surgical Avulsion of Mandibular Third Molars: A Randomized, Controlled, Clinical Trial.","OBJECTIVE


The objective of this analysis was to compare the efficacy of etoricoxib and diclofenac in the management of perioperative sequelae following impacted mandibular third molar surgery.
MATERIALS AND METHODS


Ninety-seven patients who needed surgical avulsion of an impacted mandibular third molar were chosen for the study. All patients were randomly allocated to receive one of the following treatments, twice a day for 5 days after surgery: placebo (n=33), diclofenac (n=32), or etoricoxib (n=32). The primary outcome evaluated was postoperative pain, recorded by each patient and evaluated using the Visual Analogue Scale score. The secondary outcomes chosen were, compared with preoperative ones, changes in postoperative swelling and maximum mouth opening.
RESULTS


Compared with placebo, treatment with etoricoxib and diclofenac demonstrated an enhancement in the primary outcome. Furthermore, when compared with the other groups, patients who had undergone etoricoxib presented a significant median reduction in postoperative pain at 2 hours (P<0.001), 12 hours (P=0.025), and at 48 hours (P=0.018) after surgery. Moreover, the linear regression analysis showed that diclofenac and etoricoxib determined a significant influence on Visual Analogue Scale at 2, 6, 12, 24, 48 hours and at 10 days after surgery. There were no differences in swelling and maximum mouth opening values between groups.
DISCUSSION


This study demonstrated that both treatments were effective. However, treatment with etoricoxib showed a greater reduction in the incidence and severity of postoperative pain following third molar surgery compared with diclofenac and placebo.",2019,"There were no differences in swelling and maximum mouth opening values between groups.
","['Ninety-seven patients who needed surgical avulsion of an impacted mandibular third molar were chosen for the study', 'impacted mandibular third molar surgery']","['Etoricoxib and Diclofenac', 'diclofenac', 'placebo', 'etoricoxib', 'etoricoxib and diclofenac']","['postoperative pain', 'visual analogue scale (VAS) score', 'incidence and severity of postoperative pain', 'Pain and Perioperative Sequelae', 'VAS', 'swelling and maximum mouth opening values', 'postoperative swelling and maximum mouth opening']","[{'cui': 'C0439073', 'cui_str': '97 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0185044', 'cui_str': 'Avulsion - action (qualifier value)'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0026369', 'cui_str': 'Tooth, Wisdom'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0972314', 'cui_str': 'etoricoxib'}, {'cui': 'C0012091', 'cui_str': 'Diclofenac'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0243088', 'cui_str': 'sequelae'}, {'cui': 'C0038999', 'cui_str': 'Bulging (morphologic abnormality)'}, {'cui': 'C0230028', 'cui_str': 'Structure of oral region of face'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]",97.0,0.462934,"There were no differences in swelling and maximum mouth opening values between groups.
","[{'ForeName': 'Gaetano', 'Initials': 'G', 'LastName': 'Isola', 'Affiliation': 'Department of General Surgery and Surgical-Medical Specialties, School of Dentistry, University of Catania, Catania.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Matarese', 'Affiliation': 'Department of Biomedical and Odontostomatological Sciences and Morphological and Functional Images, School of Dentistry.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Alibrandi', 'Affiliation': 'Unit of Statistical and Mathematical Sciences, Department of Economics, University of Messina, Messina.'}, {'ForeName': 'Domenico', 'Initials': 'D', 'LastName': 'Dalessandri', 'Affiliation': 'Department of Medical and Surgical Specialties, Radiological Sciences and Public Health, Dental School, University of Brescia, Brescia.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Migliorati', 'Affiliation': 'Department of Odontostomatology, School of Dentistry, University of Genova, Genova, Italy.'}, {'ForeName': 'Eugenio', 'Initials': 'E', 'LastName': 'Pedullà', 'Affiliation': 'Department of General Surgery and Surgical-Medical Specialties, School of Dentistry, University of Catania, Catania.'}, {'ForeName': 'Ernesto', 'Initials': 'E', 'LastName': 'Rapisarda', 'Affiliation': 'Department of General Surgery and Surgical-Medical Specialties, School of Dentistry, University of Catania, Catania.'}]",The Clinical journal of pain,['10.1097/AJP.0000000000000748']
866,32492148,"The Type and Amount of Dietary Fat Affect Plasma Factor VIIc, Fibrinogen, and PAI-1 in Healthy Individuals and Individuals at High Cardiovascular Disease Risk: 2 Randomized Controlled Trials.","BACKGROUND


Factor VIIc, fibrinogen, and plasminogen activator inhibitor 1 (PAI-1) are cardiovascular disease (CVD) risk factors and are modulated, in part, by fat type and amount.
OBJECTIVE


We evaluated fat type and amount on the primary outcomes: factor VIIc, fibrinogen, and PAI-1.
METHODS


In the Dietary Effects on Lipoproteins and Thrombogenic Activity (DELTA) Trial, 2 controlled crossover feeding studies evaluated substituting carbohydrate or MUFAs for SFAs. Study 1: healthy participants (n = 103) were provided with (8 wk) an average American diet [AAD; designed to provide 37% of energy (%E) as fat, 16% SFA], a Step 1 diet (30%E fat, 9% SFA), and a diet low in SFA (Low-Sat; 26%E fat, 5% SFA). Study 2: participants (n = 85) at risk for CVD and metabolic syndrome (MetSyn) were provided with (7 wk) an AAD, a step 1 diet, and a high-MUFA diet (designed to provide 37%E fat, 8% SFA, 22% MUFA).
RESULTS


Study 1: compared with AAD, the Step 1 and Low-Sat diets decreased mean factor VIIc by 1.8% and 2.6% (overall P = 0.0001), increased mean fibrinogen by 1.2% and 2.8% (P = 0.0141), and increased mean square root PAI-1 by 0.0% and 6.0% (P = 0.0037), respectively. Study 2: compared with AAD, the Step 1 and high-MUFA diets decreased mean factor VIIc by 4.1% and 3.2% (overall P < 0.0001), increased mean fibrinogen by 3.9% and 1.5% (P = 0.0083), and increased mean square-root PAI-1 by 2.0% and 5.8% (P = 0.1319), respectively.
CONCLUSIONS


Replacing SFA with carbohydrate decreased factor VIIc and increased fibrinogen in healthy and metabolically unhealthy individuals and also increased PAI-1 in healthy subjects. Replacing SFA with MUFA decreased factor VIIc and increased fibrinogen but less than carbohydrate. Our results indicate an uncertain effect of replacing SFA with carbohydrate or MUFA on cardiometabolic risk because of small changes in hemostatic factors and directionally different responses to decreasing SFA. This trial was registered at https://clinicaltrials.gov/ct2/show/NCT00000538?term=NCT00000538&rank=1 as NCT00000538.",2020,"CONCLUSIONS


Replacing SFA with carbohydrate decreased factor VIIc and increased fibrinogen in healthy and metabolically unhealthy individuals and also increased PAI-1 in healthy subjects.","['Healthy Individuals and Individuals at High Cardiovascular Disease Risk', 'Study 1: healthy participants (n\xa0=\xa0103', 'healthy subjects', 'Study 2: participants (n\xa0=\xa085) at risk for']",['carbohydrate or MUFAs'],"['mean square-root PAI-1', 'mean fibrinogen', 'factor\xa0VIIc and increased fibrinogen', 'CVD and metabolic syndrome (MetSyn', 'mean factor VIIc', 'mean square root PAI-1', 'factor VIIc, fibrinogen, and PAI-1', 'Lipoproteins and Thrombogenic Activity (DELTA']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C1444641', 'cui_str': 'At risk'}]","[{'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0015687', 'cui_str': 'Monounsaturated fatty acid'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0030190', 'cui_str': 'Plasminogen activator inhibitor-1'}, {'cui': 'C0016006', 'cui_str': 'Fibrinogen'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0023820', 'cui_str': 'Lipoprotein'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",103.0,0.0521474,"CONCLUSIONS


Replacing SFA with carbohydrate decreased factor VIIc and increased fibrinogen in healthy and metabolically unhealthy individuals and also increased PAI-1 in healthy subjects.","[{'ForeName': 'Penny M', 'Initials': 'PM', 'LastName': 'Kris-Etherton', 'Affiliation': 'Department of Nutritional Sciences, The Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Paul W', 'Initials': 'PW', 'LastName': 'Stewart', 'Affiliation': 'Department of Biostatistics, Collaborative Studies Coordinating Center, The University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Henry N', 'Initials': 'HN', 'LastName': 'Ginsberg', 'Affiliation': 'Department of Medicine, Irving Center for Clinical Research, Columbia University College of Physicians and Surgeons, New York, NY, USA.'}, {'ForeName': 'Russell P', 'Initials': 'RP', 'LastName': 'Tracy', 'Affiliation': 'Colchester Research Facility, University of Vermont, Colchester, VT, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Lefevre', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, LA, USA.'}, {'ForeName': 'Patricia J', 'Initials': 'PJ', 'LastName': 'Elmer', 'Affiliation': 'Division of Epidemiology, University of Minnesota School of Public Health, Minneapolis, MN, USA.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Berglund', 'Affiliation': 'Department of Medicine, Irving Center for Clinical Research, Columbia University College of Physicians and Surgeons, New York, NY, USA.'}, {'ForeName': 'Abby G', 'Initials': 'AG', 'LastName': 'Ershow', 'Affiliation': 'Division of Heart and Vascular Diseases, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Pearson', 'Affiliation': 'The Mary Imogene Bassett Research Institute, Cooperstown, NY, USA.'}, {'ForeName': 'Rajasekhar', 'Initials': 'R', 'LastName': 'Ramakrishnan', 'Affiliation': 'Department of Medicine, Irving Center for Clinical Research, Columbia University College of Physicians and Surgeons, New York, NY, USA.'}, {'ForeName': 'Stephen F', 'Initials': 'SF', 'LastName': 'Holleran', 'Affiliation': 'Department of Medicine, Irving Center for Clinical Research, Columbia University College of Physicians and Surgeons, New York, NY, USA.'}, {'ForeName': 'Barbara H', 'Initials': 'BH', 'LastName': 'Dennis', 'Affiliation': 'Department of Biostatistics, Collaborative Studies Coordinating Center, The University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Champagne', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, LA, USA.'}, {'ForeName': 'Wahida', 'Initials': 'W', 'LastName': 'Karmally', 'Affiliation': 'Department of Medicine, Irving Center for Clinical Research, Columbia University College of Physicians and Surgeons, New York, NY, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of nutrition,['10.1093/jn/nxaa137']
867,28421384,The efficacy of Guolin-Qigong on the body-mind health of Chinese women with breast cancer: a randomized controlled trial.,"PURPOSE


This study was to evaluate the efficacy of a complementary Chinese treatment modality Guolin-Qigong (GLQG) for patients with breast cancer on the body-mind health.
METHODS


A randomized controlled clinical trial was conducted among 158 women with breast cancer. Subjects were randomized to receive GLQG (test group) versus a physical stretching program (control group) following conventional treatment for breast cancer. GLQG and stretching interventions were performed twice a week over 24 weeks. The primary outcome was the change in quality of life (QoL). Secondary outcome measures included anxiety, depression, and clinical indicators. All participants were assessed at four time-points, at the beginning of the study (T1), after 12 weeks of the intervention (T2), immediately after 24-week intervention (T3), and at 48-week follow-up visit (T4).
RESULTS


Improvements in QoL were evident in both groups but the test group fared better than the control group at the 12th week (P < 0.01) and particularly in emotional well-being (P < 0.01) and breast cancer-specific well-being (P < 0.001). The test group showed an improvement in anxiety levels (P < 0.01), whereas the control group showed improvements in depression (P < 0.05) but there was no significant difference between groups (P > 0.05). Both groups showed improvements in immunological function and the test group fared better than the control in TNF-α levels (P < 0.05). The results in subjects who practiced more than 4 times and 6 h per week were similar to that of all subjects; however, the improvement in anxiety in the GLQG group was more obvious. There are positive correlations between QoL and anxiety and depression.
CONCLUSIONS


Both GLQG and physical stretching are beneficial during recovery following breast cancer. GLQC was more effective in terms of Qol improvements than physical stretching. Both programs brought improvements in anxiety or depression but had were comparable. GLQC group had a greater effect on immunological function than physical exercise.",2017,"RESULTS


Improvements in QoL were evident in both groups but the test group fared better than the control group at the 12th week (P < 0.01) and particularly in emotional well-being (P < 0.01) and breast cancer-specific well-being (P ","['patients with breast cancer on the body-mind health', 'Chinese women with breast cancer', '158 women with breast cancer']","['GLQG and stretching interventions', 'complementary Chinese treatment modality Guolin-Qigong (GLQG', 'GLQG and physical stretching', 'Guolin-Qigong', 'GLQC', 'GLQG', 'physical stretching program (control group) following conventional treatment']","['anxiety, depression, and clinical indicators', 'QoL and anxiety and depression', 'depression', 'anxiety or depression', 'anxiety levels', 'change in quality of life (QoL', 'QoL', 'TNF-α levels', 'immunological function', 'anxiety', 'breast cancer-specific well-being (P']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0600080', 'cui_str': 'Stretching procedure (procedure)'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0282077', 'cui_str': ""Ch'i Kung""}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety (observable entity)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0034380'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205470', 'cui_str': 'Immunologic (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0205369', 'cui_str': 'Specified'}]",158.0,0.0495292,"RESULTS


Improvements in QoL were evident in both groups but the test group fared better than the control group at the 12th week (P < 0.01) and particularly in emotional well-being (P < 0.01) and breast cancer-specific well-being (P ","[{'ForeName': 'Pei', 'Initials': 'P', 'LastName': 'Liu', 'Affiliation': 'School of Chinese Medicine, The University of Hong Kong, 10 Sassoon Road, Pokfulam, Hong Kong.'}, {'ForeName': 'Jieshu', 'Initials': 'J', 'LastName': 'You', 'Affiliation': 'School of Chinese Medicine, The University of Hong Kong, 10 Sassoon Road, Pokfulam, Hong Kong.'}, {'ForeName': 'Wing T Y', 'Initials': 'WTY', 'LastName': 'Loo', 'Affiliation': 'School of Chinese Medicine, The University of Hong Kong, 10 Sassoon Road, Pokfulam, Hong Kong.'}, {'ForeName': 'Youzhi', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'School of Chinese Medicine, The University of Hong Kong, 10 Sassoon Road, Pokfulam, Hong Kong.'}, {'ForeName': 'Yanhua', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': 'School of Chinese Medicine, The University of Hong Kong, 10 Sassoon Road, Pokfulam, Hong Kong.'}, {'ForeName': 'Huiping', 'Initials': 'H', 'LastName': 'Sit', 'Affiliation': 'Department of Sports Science and Physical Education, The Chinese University of Hong Kong, Pokfulam, Hong Kong.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Jia', 'Affiliation': 'School of Chinese Medicine, The University of Hong Kong, 10 Sassoon Road, Pokfulam, Hong Kong.'}, {'ForeName': 'Meikuen', 'Initials': 'M', 'LastName': 'Wong', 'Affiliation': 'School of Chinese Medicine, The University of Hong Kong, 10 Sassoon Road, Pokfulam, Hong Kong.'}, {'ForeName': 'Zhiyu', 'Initials': 'Z', 'LastName': 'Xia', 'Affiliation': ""School of Public Health, Peking University, Beijing, 100191, People's Republic of China.""}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Zheng', 'Affiliation': 'School of Chinese Medicine, The University of Hong Kong, 10 Sassoon Road, Pokfulam, Hong Kong.'}, {'ForeName': 'Zhiyu', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'School of Chinese Medicine, The University of Hong Kong, 10 Sassoon Road, Pokfulam, Hong Kong.'}, {'ForeName': 'Neng', 'Initials': 'N', 'LastName': 'Wang', 'Affiliation': 'School of Chinese Medicine, The University of Hong Kong, 10 Sassoon Road, Pokfulam, Hong Kong.'}, {'ForeName': 'Lixing', 'Initials': 'L', 'LastName': 'Lao', 'Affiliation': 'School of Chinese Medicine, The University of Hong Kong, 10 Sassoon Road, Pokfulam, Hong Kong.'}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'School of Chinese Medicine, The University of Hong Kong, 10 Sassoon Road, Pokfulam, Hong Kong. abchen@hku.hk.'}]","Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation",['10.1007/s11136-017-1576-7']
868,32492293,A Randomized Trial of Hydroxychloroquine as Postexposure Prophylaxis for Covid-19.,"BACKGROUND


Coronavirus disease 2019 (Covid-19) occurs after exposure to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). For persons who are exposed, the standard of care is observation and quarantine. Whether hydroxychloroquine can prevent symptomatic infection after SARS-CoV-2 exposure is unknown.
METHODS


We conducted a randomized, double-blind, placebo-controlled trial across the United States and parts of Canada testing hydroxychloroquine as postexposure prophylaxis. We enrolled adults who had household or occupational exposure to someone with confirmed Covid-19 at a distance of less than 6 ft for more than 10 minutes while wearing neither a face mask nor an eye shield (high-risk exposure) or while wearing a face mask but no eye shield (moderate-risk exposure). Within 4 days after exposure, we randomly assigned participants to receive either placebo or hydroxychloroquine (800 mg once, followed by 600 mg in 6 to 8 hours, then 600 mg daily for 4 additional days). The primary outcome was the incidence of either laboratory-confirmed Covid-19 or illness compatible with Covid-19 within 14 days.
RESULTS


We enrolled 821 asymptomatic participants. Overall, 87.6% of the participants (719 of 821) reported a high-risk exposure to a confirmed Covid-19 contact. The incidence of new illness compatible with Covid-19 did not differ significantly between participants receiving hydroxychloroquine (49 of 414 [11.8%]) and those receiving placebo (58 of 407 [14.3%]); the absolute difference was -2.4 percentage points (95% confidence interval, -7.0 to 2.2; P = 0.35). Side effects were more common with hydroxychloroquine than with placebo (40.1% vs. 16.8%), but no serious adverse reactions were reported.
CONCLUSIONS


After high-risk or moderate-risk exposure to Covid-19, hydroxychloroquine did not prevent illness compatible with Covid-19 or confirmed infection when used as postexposure prophylaxis within 4 days after exposure. (Funded by David Baszucki and Jan Ellison Baszucki and others; ClinicalTrials.gov number, NCT04308668.).",2020,"Side effects were more common with hydroxychloroquine than with placebo (40.1% vs. 16.8%), but no serious adverse reactions were reported.
","['United States and parts of Canada testing', '821 asymptomatic participants', 'enrolled adults who had household or occupational exposure to someone with confirmed Covid-19 at a distance of less than 6 ft for more than 10 minutes while wearing neither a face mask nor an eye shield (high-risk exposure) or while wearing a face mask but no eye shield (moderate-risk exposure']","['placebo', 'Hydroxychloroquine', 'placebo or hydroxychloroquine', 'hydroxychloroquine']","['Side effects', 'incidence of new illness compatible with Covid-19', 'incidence of either laboratory-confirmed Covid-19 or illness compatible with Covid-19 within 14 days', 'serious adverse reactions']","[{'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0454979', 'cui_str': 'Part of Canada'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0028798', 'cui_str': 'Exposure, Occupational'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0183251', 'cui_str': 'Shield'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0332290', 'cui_str': 'Consistent with'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}]",821.0,0.751633,"Side effects were more common with hydroxychloroquine than with placebo (40.1% vs. 16.8%), but no serious adverse reactions were reported.
","[{'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Boulware', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Matthew F', 'Initials': 'MF', 'LastName': 'Pullen', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Ananta S', 'Initials': 'AS', 'LastName': 'Bangdiwala', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Katelyn A', 'Initials': 'KA', 'LastName': 'Pastick', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Sarah M', 'Initials': 'SM', 'LastName': 'Lofgren', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Okafor', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Caleb P', 'Initials': 'CP', 'LastName': 'Skipper', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Alanna A', 'Initials': 'AA', 'LastName': 'Nascene', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Melanie R', 'Initials': 'MR', 'LastName': 'Nicol', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Mahsa', 'Initials': 'M', 'LastName': 'Abassi', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Nicole W', 'Initials': 'NW', 'LastName': 'Engen', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Cheng', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'LaBar', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Sylvain A', 'Initials': 'SA', 'LastName': 'Lother', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Lauren J', 'Initials': 'LJ', 'LastName': 'MacKenzie', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Glen', 'Initials': 'G', 'LastName': 'Drobot', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Marten', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Zarychanski', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Lauren E', 'Initials': 'LE', 'LastName': 'Kelly', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Ilan S', 'Initials': 'IS', 'LastName': 'Schwartz', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Emily G', 'Initials': 'EG', 'LastName': 'McDonald', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Radha', 'Initials': 'R', 'LastName': 'Rajasingham', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Todd C', 'Initials': 'TC', 'LastName': 'Lee', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Kathy H', 'Initials': 'KH', 'LastName': 'Hullsiek', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}]",The New England journal of medicine,['10.1056/NEJMoa2016638']
869,32090660,Benefits of EEG-Neurofeedback on the Modulation of Impulsivity in a Sample of Cocaine and Heroin Long-Term Abstinent Inmates: A Pilot Study.,"The aim of this pilot study was to assess whether neurofeedback (NFB) can be useful in the treatment of impulsive behavior in long-term abstinent cocaine and heroin addicts. A single-blind sham-controlled NFB protocol was carried out to assess the effects of NFB on impulsivity in 20 (10 + 10) cocaine and heroin long-term abstinent addicts ( Diagnostic and Statistical Manual of Mental Disorders  [4th ed., text rev.;  DSM-IV-TR ]). Psychotic and neurologic diseases were excluded. Participants underwent 40 NFB sessions based on the very slow cortical potential range. Inhibitory deficits were specifically addressed through right and left prefrontal training. Clinical improvement was measured with Likert-type scales, the Hamilton Depression Rating Scale, and the State-Trait Anxiety Inventory, and impulsivity was assessed using the Barratt Impulsiveness Scale and the Continuous Performance Test. Although the results are preliminary due to the small sample size, the NFB-treated group showed a significant clinical improvement, including symptoms of anxiety and depression, with two differentiated time periods. No significant clinical improvement was found in the control group. A significant decrease in the post- versus pre-treatment measures of global impulsivity, nonplanning impulsivity, and error commission measures was found in the NFB-treated group; effect size ( d Korr ) in the pre-post control design was moderate. No significant change was found in the control group. Despite the limitations of this study, the results suggest that NFB is better than placebo in improving impulsivity and clinical symptoms of anxiety and depression in long-term abstinent cocaine- and heroin-dependent individuals.",2020,"A significant decrease in the post- versus pre-treatment measures of global impulsivity, nonplanning impulsivity, and error commission measures was found in the NFB-treated group; effect size ( d Korr ) in the pre-post control design was moderate.","['Impulsivity in a Sample of Cocaine and Heroin Long-Term Abstinent Inmates', 'impulsive behavior in long-term abstinent cocaine and heroin addicts']","['placebo', 'neurofeedback (NFB', 'EEG-Neurofeedback', 'NFB', 'cocaine and heroin long-term abstinent addicts']","['Inhibitory deficits', 'Barratt Impulsiveness Scale and the Continuous Performance Test', 'Likert-type scales, the Hamilton Depression Rating Scale, and the State-Trait Anxiety Inventory, and impulsivity', 'global impulsivity, nonplanning impulsivity, and error commission measures', 'Psychotic and neurologic diseases', 'impulsivity and clinical symptoms of anxiety and depression', 'symptoms of anxiety and depression']","[{'cui': 'C0021125', 'cui_str': 'Impulsivity'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0011892', 'cui_str': 'diamorphine'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0457801', 'cui_str': 'Current non-drinker of alcohol (finding)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2713543', 'cui_str': 'Neurofeedback'}, {'cui': 'C0013819', 'cui_str': 'EEG'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0011892', 'cui_str': 'diamorphine'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0457801', 'cui_str': 'Current non-drinker of alcohol (finding)'}]","[{'cui': 'C0564567', 'cui_str': 'Impulsive character (finding)'}, {'cui': 'C0222045'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0021125', 'cui_str': 'Impulsivity'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0033975', 'cui_str': 'Psychoses'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0175654,"A significant decrease in the post- versus pre-treatment measures of global impulsivity, nonplanning impulsivity, and error commission measures was found in the NFB-treated group; effect size ( d Korr ) in the pre-post control design was moderate.","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Corominas-Roso', 'Affiliation': ""Psychiatry Department, Hospital Universitari Vall d'Hebron, Universitat Autònoma de Barcelona, Spain.""}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Ibern', 'Affiliation': 'Generalitat de Catalunya, Barcelona, Spain.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Capdevila', 'Affiliation': 'Generalitat de Catalunya, Barcelona, Spain.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Ramon', 'Affiliation': 'Generalitat de Catalunya, Barcelona, Spain.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Roncero', 'Affiliation': 'Biomedical Network Research Center on Mental Health, Madrid, Spain.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Ramos-Quiroga', 'Affiliation': ""Psychiatry Department, Hospital Universitari Vall d'Hebron, Universitat Autònoma de Barcelona, Spain.""}]",International journal of offender therapy and comparative criminology,['10.1177/0306624X20904704']
870,27636349,Detraining-induced alterations in adipokines and cardiometabolic risk factors after nonlinear periodized resistance and aerobic interval training in obese men.,"This study compared the effects of nonlinear resistance training (NRT), aerobic interval training (AIT), and detraining on adipokines and cardiometabolic risk factors in middle-aged obese men. Thirty-three obese men were randomly allocated to NRT (n = 12), AIT (n = 10), and control (CON, n = 11) groups. Subjects in experimental groups performed exercise protocols 3 days per week for 12 weeks followed by a 4-week detraining period. The NRT involved 55 min of weight training with flexible periodization. The AIT consisted of running on a treadmill (4 × 4-min intervals at 90% of maximal heart rate, with each interval separated by 3 min at 65%). Peak oxygen consumption increased significantly after training compared with CON (P < 0.01), but it increased more in the AIT group than in the NRT group (P = 0.004). After detraining, peak oxygen consumption decreased significantly in both training groups (P < 0.001); however, the value in the AIT group was still higher than that in the CON group (P = 0.003). No significant changes were observed in serum levels of omentin-1 and interleukin (IL)-18 after training (P > 0.05), but omentin-1 decreased significantly in both training groups and IL-18 increased significantly in the NRT group after detraining (P < 0.05). High-density lipoprotein cholesterol (HDL-C) increased significantly after training in the AIT group compared with the CON group (P < 0.05) and returned to the pre-training level after detraining. Conversely, apelin-13 increased significantly in response to training, compared with baseline (P < 0.05), and remained unchanged after detraining. Both training regimens had similar effects on most markers; however, AIT seems to have stronger anti-coronary disease effects (as indicated by HDL-C and peak oxygen consumption) than NRT.",2016,"No significant changes were observed in serum levels of omentin-1 and interleukin (IL)-18 after training (P > 0.05), but omentin-1 decreased significantly in both training groups and IL-18 increased significantly in the NRT group after detraining (P < 0.05).","['middle-aged obese men', 'Thirty-three obese men', 'obese men']","['NRT', 'nonlinear resistance training (NRT), aerobic interval training (AIT), and detraining', 'CON', 'aerobic interval training']","['High-density lipoprotein cholesterol (HDL-C', 'peak oxygen consumption', 'serum levels of omentin-1 and interleukin (IL)-18', 'IL-18', 'adipokines and cardiometabolic risk factors', 'Peak oxygen consumption']","[{'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0450358', 'cui_str': '33 (qualifier value)'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0023822', 'cui_str': 'High Density Lipoprotein Cholesterol'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0383327', 'cui_str': 'Interferon-gamma-Inducing Factor'}, {'cui': 'C1955907', 'cui_str': 'Adipocytokines'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}]",,0.0174823,"No significant changes were observed in serum levels of omentin-1 and interleukin (IL)-18 after training (P > 0.05), but omentin-1 decreased significantly in both training groups and IL-18 increased significantly in the NRT group after detraining (P < 0.05).","[{'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Nikseresht', 'Affiliation': 'a Department of Exercise Physiology, Islamic Azad University, Ilam Branch, Ilam, Iran.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Hafezi Ahmadi', 'Affiliation': 'b Department of Pathobiology, Faculty of Medicine, Ilam University of Medical Sciences, Ilam, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Hedayati', 'Affiliation': 'c Cellular & Molecular Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]","Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme",[]
871,27513339,The Effect of Protandim® Supplementation on Athletic Performance and Oxidative Blood Markers in Runners.,"UNLABELLED


The purpose of this study determined if oral supplementation of Protandim® (a nutraceutical) for 90 days improved 5-km running performance and reduced serum thiobarbituric acid-reacting substances (TBARS) at rest, an indicator of oxidative stress. Secondary objectives were to measure whole blood superoxide dismutase (SOD), glutathione (GSH), and glutathione peroxidase (GPX), at rest and 10 minutes after completion of the race before and after supplementation as well as quality of life. In a double-blind, randomized, placebo controlled trial, 38 runners [mean (SD) = 34 (7) yrs; BMI = 22 (2) kg/m2] received either 90 days of Protandim® [1 pill a day, n = 19)] or placebo (n = 19). Randomization was done in blocks of two controlling for sex and 5-km baseline performance. A 5-km race was performed at baseline and after 90 days of supplementation, with blood samples taken before and 10-min after each race. Fasting blood samples were acquired at baseline, after 30, 60, and 90 days of supplementation. TBARS, SOD, GPX, and GSH were assayed in an out-of-state accredited lab. Running performance was not altered by Protandim® or placebo [20.3 (2.1) minutes, with an -8 (33) seconds change in 5-km time regardless of group]. There was no change in TBARS, SOD, or GPX (at rest) after three months of Protandim® supplementation compared to placebo. However, in a subgroup ≥ 35 years of age, there was a 2-fold higher increase in SOD in those taking Protandim® for three months compared to those on placebo (p = 0.038). The mean post-race change in TBARS (compared to pre-race) increased by about 20% in half of the subjects, but was not altered between groups, even after three months of supplementation. Quality of life was also not different between the two conditions. In conclusion, Protandim® did not (1) alter 5-km running time, (2) lower TBARS at rest (3) raise antioxidant enzyme concentrations compared to placebo (with exception of SOD in those ≥ 35 years old) or, (4) affect quality of life compared to placebo.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02172625.",2016,"There was no change in TBARS, SOD, or GPX (at rest) after three months of Protandim® supplementation compared to placebo.","['Runners', '38 runners [mean (SD) = 34 (7) yrs; BMI = 22 (2) kg/m2']","['Protandim®', 'Protandim® or placebo', 'Protandim® Supplementation', 'placebo']","['mean post-race change in TBARS', 'quality of life', 'Quality of life', 'Protandim® did not (1) alter 5-km running time, (2) lower TBARS at rest (3) raise antioxidant enzyme concentrations', 'TBARS, SOD, GPX, and GSH', '5-km running performance and reduced serum thiobarbituric acid-reacting substances (TBARS', 'SOD', 'Fasting blood samples', 'Athletic Performance and Oxidative Blood Markers', 'TBARS, SOD, or GPX', 'blood superoxide dismutase (SOD), glutathione (GSH), and glutathione peroxidase (GPX), at rest and 10 minutes after completion of the race before and after supplementation as well as quality of life']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}]","[{'cui': 'C1700049', 'cui_str': 'Protandim'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0162781', 'cui_str': 'TBARs'}, {'cui': 'C0034380'}, {'cui': 'C1700049', 'cui_str': 'Protandim'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0443144', 'cui_str': 'At rest (qualifier value)'}, {'cui': 'C0442818', 'cui_str': 'Raised (qualifier value)'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C3541394', 'cui_str': 'Enzymes'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0076442', 'cui_str': 'thiobarbituric acid'}, {'cui': 'C4224854', 'cui_str': 'React'}, {'cui': 'C0439861', 'cui_str': 'Substance (substance)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0871966', 'cui_str': 'Sports Performance'}, {'cui': 'C0005768'}, {'cui': 'C0069638', 'cui_str': 'orgotein'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0017822', 'cui_str': 'Glutathione:hydrogen-peroxide oxidoreductase'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}]",38.0,0.482903,"There was no change in TBARS, SOD, or GPX (at rest) after three months of Protandim® supplementation compared to placebo.","[{'ForeName': 'Seteena L', 'Initials': 'SL', 'LastName': 'Ueberschlag', 'Affiliation': 'Department of Health and Sport Sciences, University of Louisville, Louisville, KY, United States of America.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Seay', 'Affiliation': 'Department of Health and Sport Sciences, University of Louisville, Louisville, KY, United States of America.'}, {'ForeName': 'Alexandra H', 'Initials': 'AH', 'LastName': 'Roberts', 'Affiliation': 'Department of Health and Sport Sciences, University of Louisville, Louisville, KY, United States of America.'}, {'ForeName': 'Pamela C', 'Initials': 'PC', 'LastName': 'DeSpirito', 'Affiliation': 'Department of Medicine, University of Louisville, Louisville, KY, United States of America.'}, {'ForeName': 'Jeremy M', 'Initials': 'JM', 'LastName': 'Stith', 'Affiliation': 'Department of Clinical Sciences, University of Kentucky, Lexington, KY, United States of America.'}, {'ForeName': 'Rodney J', 'Initials': 'RJ', 'LastName': 'Folz', 'Affiliation': 'Department of Medicine, Case Western Reserve University, Cleveland, OH, United States of America.'}, {'ForeName': 'Kathleen A', 'Initials': 'KA', 'LastName': 'Carter', 'Affiliation': 'Department of Health and Sport Sciences, University of Louisville, Louisville, KY, United States of America.'}, {'ForeName': 'Edward P', 'Initials': 'EP', 'LastName': 'Weiss', 'Affiliation': 'Department of Nutrition and Dietetics, Saint Louis University, Saint Louis, MO, United States of America.'}, {'ForeName': 'Gerald S', 'Initials': 'GS', 'LastName': 'Zavorsky', 'Affiliation': 'Department of Respiratory Therapy, Georgia State University, Atlanta, GA, United States of America.'}]",PloS one,['10.1371/journal.pone.0160559']
872,30198774,Effectiveness of motivational interviewing to improve oral hygiene in orthodontic patients: A randomized controlled trial.,"Maintaining good oral hygiene in patients wearing fixed appliances is a challenge for orthodontics. Conventional education has been demonstrated to be insufficient for the promotion of good oral habits, while motivational interviewing has the potential to facilitate health behavior change. The present randomized controlled trial with 130 patients aimed to evaluate the effectiveness of a single session of motivational interviewing in enhancing oral hygiene in orthodontic patients compared with conventional education alone. Results revealed an immediate improvement in oral hygiene which remained stable throughout the 6-month follow-up.",2020,Results revealed an immediate improvement in oral hygiene which remained stable throughout the 6-month follow-up.,"['orthodontic patients', '130 patients', 'patients wearing fixed appliances']","['motivational interviewing', 'conventional education alone']",['oral hygiene'],"[{'cui': 'C0029335', 'cui_str': 'Orthodontics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0441421', 'cui_str': 'Permanent Retainer'}]","[{'cui': 'C0683474', 'cui_str': 'Motivational Interviewing'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C1272386', 'cui_str': 'Mouth care management'}]",130.0,0.0387587,Results revealed an immediate improvement in oral hygiene which remained stable throughout the 6-month follow-up.,"[{'ForeName': 'Maria-Montserrat', 'Initials': 'MM', 'LastName': 'Rigau-Gay', 'Affiliation': 'Universitat de Barcelona, Spain.'}, {'ForeName': 'Eduard', 'Initials': 'E', 'LastName': 'Claver-Garrido', 'Affiliation': 'Bellvitge Biomedical Research Institute (IDIBELL), Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Benet', 'Affiliation': 'Global Health Institute Barcelona (ISGlobal), Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Lusilla-Palacios', 'Affiliation': ""Vall d'Hebron Research Institute (VHIR), Spain.""}, {'ForeName': 'Josep-Maria', 'Initials': 'JM', 'LastName': 'Ustrell-Torrent', 'Affiliation': 'Universitat de Barcelona, Spain.'}]",Journal of health psychology,['10.1177/1359105318793719']
873,32414405,"""[Repeat] testing and counseling is one of the key [services] that the government should continue providing"": participants' perceptions on extended repeat HIV testing and enhanced counseling (ERHTEC) for primary HIV prevention in pregnant and lactating women in the PRIMAL study, Uganda.","BACKGROUND


The 'Primary HIV Prevention among Pregnant and Lactating Ugandan Women' (PRIMAL) randomized controlled trial aimed to assess an enhanced counseling strategy linked to extended postpartum repeat HIV testing and enhanced counseling among 820 HIV-negative pregnant and lactating women aged 18-49 years and 410 of their male partners to address the first pillar of the WHO Global Strategy for the Prevention of Mother-to-Child HIV transmission (PMTCT). This paper presents findings of qualitative studies aimed at evaluating participants' and service providers' perceptions on the acceptability and feasibility of the intervention and at understanding the effects of the intervention on risk reduction, couple communication, and emotional support from women's partners.
METHODS


PRIMAL Study participants were enrolled from two antenatal care clinics and randomized 1:1 to an intervention or control arm. Both arms received repeat sexually transmitted infections (STI) and HIV testing at enrolment, labor and delivery, and at 3, 6, 12, 18 and 24 months postpartum. The intervention consisted of enhanced quarterly counseling on HIV risk reduction, couple communication, family planning and nutrition delivered by study counselors through up to 24 months post-partum. Control participants received repeat standard post-test counseling. Qualitative data were collected from intervention women participants, counsellors and midwives at baseline, midline and end of the study through 18 focus group discussions and 44 key informant interviews. Data analysis followed a thematic approach using framework analysis and a matrix-based system for organizing, reducing, and synthesizing data.
RESULTS


At baseline, FGD participants mentioned multiple sexual partners and lack of condom use as the main risks for pregnant and lactating women to acquire HIV. The main reasons for having multiple sexual partners were 1) the cultural practice not to have sex in the late pre-natal and early post-natal period; 2) increased sexual desire during pregnancy; 3) alcohol abuse; 4) poverty; and 5) conflict in couples. Consistent condom use at baseline was limited due to lack of knowledge and low acceptance of condom use in couples. The majority of intervention participants enrolled as couples felt enhanced counselling improved understanding, faithfulness, mutual support and appreciation within their couple. Another benefit mentioned by participants was improvement of couple communication and negotiation, as well as daily decision-making around sexual needs, family planning and condom use. Participants stressed the importance of providing counselling services to all couples.
CONCLUSION


This study shows that enhanced individual and couple counselling linked to extended repeat HIV and STI testing and focusing on HIV prevention, couple communication, family planning and nutrition is a feasible and acceptable intervention that could enhance risk reduction programs among pregnant and lactating women.
TRIAL REGISTRATION


ClinicalTrials.gov registration number NCT01882998, date of registration 21st June 2013.",2020,"Another benefit mentioned by participants was improvement of couple communication and negotiation, as well as daily decision-making around sexual needs, family planning and condom use.","[""women's partners"", '820 HIV-negative pregnant and lactating women aged 18-49\u2009years and 410 of their male partners to address the first pillar of the WHO Global Strategy for the Prevention of Mother-to-Child HIV transmission (PMTCT', 'PRIMAL Study participants were enrolled from two antenatal care clinics', 'pregnant and lactating women in the PRIMAL study, Uganda', 'pregnant and lactating women', 'Pregnant and Lactating', 'Ugandan Women']","['enhanced quarterly counseling on HIV risk reduction, couple communication, family planning and nutrition delivered by study counselors through up to 24\u2009months post-partum', 'enhanced counseling strategy linked to extended postpartum repeat HIV testing and enhanced counseling', 'Repeat] testing and counseling', 'repeat standard post-test counseling']","['risk reduction, couple communication, and emotional support', 'understanding, faithfulness, mutual support and appreciation within their couple']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0481430', 'cui_str': 'HIV negative'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}]","[{'cui': 'C0332179', 'cui_str': 'Trimonthly'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0009861', 'cui_str': 'Family planning service'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1571885', 'cui_str': 'Professional counselor'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C3714360', 'cui_str': 'Counseling strategy'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0459958', 'cui_str': 'HIV screening'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0600015', 'cui_str': 'Emotional support'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0183683', 'cui_str': 'Support'}]",,0.0739136,"Another benefit mentioned by participants was improvement of couple communication and negotiation, as well as daily decision-making around sexual needs, family planning and condom use.","[{'ForeName': 'Femke', 'Initials': 'F', 'LastName': 'Bannink Mbazzi', 'Affiliation': 'Medical Research Council / Uganda Virus Research Institute & London School of Hygiene and Tropical Medicine Uganda Research Unit, P.O. Box 49, Entebbe, Uganda. femke.bannink@mrcuganda.org.'}, {'ForeName': 'Zikulah', 'Initials': 'Z', 'LastName': 'Namukwaya', 'Affiliation': 'Makerere University - Johns Hopkins University Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Amone', 'Affiliation': 'Makerere University - Johns Hopkins University Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Ojok', 'Affiliation': 'AVSI Foundation, Kampala, Uganda.'}, {'ForeName': 'Juliane', 'Initials': 'J', 'LastName': 'Etima', 'Affiliation': 'Makerere University - Johns Hopkins University Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Josaphat', 'Initials': 'J', 'LastName': 'Byamugisha', 'Affiliation': 'Department of Obstetrics and Gynecology, Makerere University School of Medicine, Kampala, Uganda.'}, {'ForeName': 'Elly', 'Initials': 'E', 'LastName': 'Katabira', 'Affiliation': 'Makerere University - Johns Hopkins University Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Mary Glenn', 'Initials': 'MG', 'LastName': 'Fowler', 'Affiliation': 'Makerere University - Johns Hopkins University Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Jaco', 'Initials': 'J', 'LastName': 'Homsy', 'Affiliation': 'Institute for Global Health Sciences, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'King', 'Affiliation': 'Institute for Global Health Sciences, University of California, San Francisco, CA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMC public health,['10.1186/s12889-020-08738-x']
874,32414347,"The PAPHIO study protocol: a randomised controlled trial with a 2 x 2 crossover design of physical activity adherence, psychological health and immunological outcomes in breast cancer survivors.","BACKGROUND


The PAPHIO study; a randomized controlled trial with 2X2 crossover design will implement a self-directed physical activity program in which participants will engage in self-monitoring and receive motivational interviewing to enhance physical activity adherence. The study aims to determine the effects of 24 weeks self-directed activity combined with motivational interviewing (MI) on (i) psychological health, (ii) quality of life (QoL) and (iii) immune function in female breast cancer survivors.
METHODS


The study will recruit 64 female breast cancer survivors within 3 years of diagnosis and at least 6 months post primary treatments at Western Health Sunshine Hospital, Melbourne, Australia. They will be randomly allocated to immediate intervention (IIG group) or delayed intervention groups (DIG group) in a 1:1 ratio. All participants will be given a wearable device (Fitbit Alta HR) and undertake self-directed physical activity for 24 weeks and will receive MI for 12 weeks (IIG; during week 0 to week 12 and DIG; during week 13 to week 24). Participants' daily step count and the changes of immune cell functionality will be assessed at the beginning (week 1: T1), week 12 (T2) and week 24 (T3) of the program. Physical activity adherence will be assessed at T2 and T3. Participants will also complete four questionnaires assessing exercise self-regulation (BREQ2), exercise barrier and task self-efficacy, mental health (DASS-21) and QoL (FACT-B) at three time points (T1 to T3). Linear-mixed models will be used to assess the relationship between physical activity volume by step counting and mental health (DASS-21), QoL (FACT-B), immune biomarkers, self-regulation (BREQ2) and self-efficacy at T1, T2 and T3;between 2 groups.
DISCUSSION


We expect this physical activity intervention to be acceptable and beneficial to the participants in terms of psychological and immunological well-being with the potential outcomes to be implemented more widely at relatively low cost to these or other patient populations.
TRIAL REGISTRATION


Australian New Zealand Clinical trials Registry- ACTRN12619001271190. Prospectively registered on 13 September 2019.",2020,"We expect this physical activity intervention to be acceptable and beneficial to the participants in terms of psychological and immunological well-being with the potential outcomes to be implemented more widely at relatively low cost to these or other patient populations.
","['Prospectively registered on 13 September 2019', 'breast cancer survivors', 'female breast cancer survivors', '64 female breast cancer survivors within 3\xa0years of diagnosis and at least 6\xa0months post primary treatments at Western Health Sunshine Hospital, Melbourne, Australia']","['physical activity intervention', 'immediate intervention (IIG group) or delayed intervention', 'physical activity adherence, psychological health', 'Registry', 'motivational interviewing', '24\u2009weeks self-directed activity combined with motivational interviewing (MI', 'self-directed physical activity program']","['Physical activity adherence', 'physical activity volume by step counting and mental health (DASS-21), QoL (FACT-B), immune biomarkers, self-regulation (BREQ2) and self-efficacy', 'i) psychological health, (ii) quality of life (QoL) and (iii) immune function', 'questionnaires assessing exercise self-regulation (BREQ2), exercise barrier and task self-efficacy, mental health (DASS-21) and QoL (FACT-B', 'immune cell functionality', 'physical activity adherence']","[{'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0235653', 'cui_str': 'Malignant neoplasm of female breast'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C1708063', 'cui_str': 'First line treatment'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038817', 'cui_str': 'Sunlight'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1832594', 'cui_str': 'Verloes Bourguignon syndrome'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1817756', 'cui_str': 'Immunologic function'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}]",,0.0682482,"We expect this physical activity intervention to be acceptable and beneficial to the participants in terms of psychological and immunological well-being with the potential outcomes to be implemented more widely at relatively low cost to these or other patient populations.
","[{'ForeName': 'Supa', 'Initials': 'S', 'LastName': 'Pudkasam', 'Affiliation': 'Institute for Health and Sport, Victoria University, Melbourne, VIC, Australia. supa.pudkasam@live.vu.edu.au.'}, {'ForeName': 'Meron', 'Initials': 'M', 'LastName': 'Pitcher', 'Affiliation': 'Breast Cancer Service, Western Health, Melbourne, VIC, Australia.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Fisher', 'Affiliation': 'Breast Cancer Service, Western Health, Melbourne, VIC, Australia.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': ""O'Connor"", 'Affiliation': 'IPC Health Altona Meadows, Melbourne, VIC, Australia.'}, {'ForeName': 'Nanthaphan', 'Initials': 'N', 'LastName': 'Chinlumprasert', 'Affiliation': 'Bernadette de Lourdes School of Nursing Science, Assumption University, Bangkok, Thailand.'}, {'ForeName': 'Lily', 'Initials': 'L', 'LastName': 'Stojanovska', 'Affiliation': 'Institute for Health and Sport, Victoria University, Melbourne, VIC, Australia.'}, {'ForeName': 'Remco', 'Initials': 'R', 'LastName': 'Polman', 'Affiliation': 'School of Exercise and Nutrition Sciences, Faculty of Health, Queensland University of Technology, Brisbane, Qld, Australia.'}, {'ForeName': 'Vasso', 'Initials': 'V', 'LastName': 'Apostolopoulos', 'Affiliation': 'Institute for Health and Sport, Victoria University, Melbourne, VIC, Australia. vasso.apostolopoulos@vu.edu.au.'}]",BMC public health,['10.1186/s12889-020-08827-x']
875,27285346,Physical effects of a reconditioning programme in a group of chronic fatigue syndrome patients.,"BACKGROUND


Physical exercise can be part of treatment in patients with chronic fatigue syndrome (CFS), where the aim would be to improve strength and endurance through increasing physical exercise (intensity and time) without aggravating symptomatology. The present study examines the effectiveness of a reconditioning programme (focusing on strength, endurance, balance and propioception) for achieving maximum functional capacity according to the clinical status of CFS patients.
METHODS


Sixty-eight patients with CFS were randomly assigned to two groups: a control group (CG) comprising 22 patients and an active group (AG) of 46 patients, the latter being invited to take part in a functional reconditioning programme based on 12 weeks of laboratory training followed by a further 12-week home training period. Functional assessments were as follows: before (I) and after (II) the laboratory training and after (III) the home training.
RESULTS


In the AG, 22 patients (67%) completed the intervention (laboratory) stage and 20 finished the whole protocol (61%). Patients in the AG showed improved static and dynamic balance, as well as significantly greater maximum strength (F=7.059, P<0.05). Differences in resistance strength were also observed, with the AG showing a 19.9% improvement between functional assessments I and II (P=0.04). We do not found changes in the CG.
CONCLUSIONS


A physical exercise programme of this kind might offer CFS patients the opportunity to improve their strength, balance and quality of life, there being only a very small risk of relapse and none of the adverse effects of other treatments.",2016,"Patients in the AG showed improved static and dynamic balance, as well as significantly greater maximum strength (F=7.059, P<0.05).","['Sixty-eight patients with CFS', 'patients with chronic fatigue syndrome (CFS', 'chronic fatigue syndrome patients', 'CFS patients']","['control group (CG) comprising 22 patients and an active group (AG) of 46 patients, the latter being invited to take part in a functional reconditioning programme based on 12 weeks of laboratory training followed by a further 12-week home training period', 'reconditioning program me', 'Physical exercise', 'reconditioning programme (focusing on strength, endurance, balance and propioception']","['resistance strength', 'maximum strength', 'strength, balance and quality of life', 'static and dynamic balance']","[{'cui': 'C0450387', 'cui_str': '68 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0015674', 'cui_str': 'Systemic Exertion Intolerance Disease'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}]","[{'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0034380'}, {'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}]",68.0,0.017378,"Patients in the AG showed improved static and dynamic balance, as well as significantly greater maximum strength (F=7.059, P<0.05).","[{'ForeName': 'Elisabet', 'Initials': 'E', 'LastName': 'Guillamo', 'Affiliation': 'Department of Physiological Sciences II, Exercise Physiology Unit, School of Medicine, University of Barcelona, Barcelona, Spain - eguillamo@ub.edu.'}, {'ForeName': 'Joan R', 'Initials': 'JR', 'LastName': 'Barbany', 'Affiliation': ''}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Blazquez', 'Affiliation': ''}, {'ForeName': 'Mari C', 'Initials': 'MC', 'LastName': 'Delicado', 'Affiliation': ''}, {'ForeName': 'Josep L', 'Initials': 'JL', 'LastName': 'Ventura', 'Affiliation': ''}, {'ForeName': 'Casimiro', 'Initials': 'C', 'LastName': 'Javierre', 'Affiliation': ''}]",The Journal of sports medicine and physical fitness,[]
876,32492688,"Prior Therapeutic Experiences, Not Expectation Ratings, Predict Placebo Effects: An Experimental Study in Chronic Pain and Healthy Participants.","INTRODUCTION


Many clinical trials fail because of placebo responses. Prior therapeutic experiences and patients' expectations may affect the capacity to respond to placebos in chronic disorders.
OBJECTIVE


The scope of this study in 763 chronic orofacial pain and healthy study participants was to compare the magnitude and prevalence of placebo effects and determine the putative role of prior therapeutic experiences vs. expectations.
METHODS


We tested placebo propensity in a laboratory setting by using 2 distinct levels of individually tailored painful stimulations (high pain and low pain) to reinforce expectations and provide a hypoalgesic experience (conditioning phase). Afterwards, both levels of pain were surreptitiously set at a moderate pain level to test for placebo effects (testing phase). Pain and expectation ratings were assessed as primary outcomes using visual analog scales.
RESULTS


In both chronic pain and healthy participants, placebo effects were similar in magnitude, with the larger prevalence of responders in the healthy participants. Although chronic pain participants reported higher pain relief expectations, expectations did not account for the occurrence of placebo effects. Rather, prior experience via conditioning strength mediated placebo effects in both pain and healthy participants.
CONCLUSIONS


These findings indicate that participants with chronic pain conditions display robust placebo effects that are not mediated by expectations but are instead directly linked to prior therapeutic experiences. This confirms the importance of assessing the therapeutic history while raising questions about the utility of expectation ratings. Future research is needed to enhance prediction of responses to placebos, which will ultimately improve clinical trial designs.",2020,"In both chronic pain and healthy participants, placebo effects were similar in magnitude, with the larger prevalence of responders in the healthy participants.","['763 chronic orofacial pain and healthy study participants', 'Chronic Pain and Healthy Participants', 'participants with chronic pain conditions', 'pain and healthy participants']",['placebo'],"['pain relief expectations', 'Pain and expectation ratings', 'visual analog scales']","[{'cui': 'C4546211', 'cui_str': 'Chronic orofacial pain'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",763.0,0.306134,"In both chronic pain and healthy participants, placebo effects were similar in magnitude, with the larger prevalence of responders in the healthy participants.","[{'ForeName': 'Luana', 'Initials': 'L', 'LastName': 'Colloca', 'Affiliation': 'Department of Pain and Translational Symptom Science, School of Nursing, University of Maryland, Baltimore, Maryland, USA, colloca@umaryland.edu.'}, {'ForeName': 'Titilola', 'Initials': 'T', 'LastName': 'Akintola', 'Affiliation': 'Department of Pain and Translational Symptom Science, School of Nursing, University of Maryland, Baltimore, Maryland, USA.'}, {'ForeName': 'Nathaniel R', 'Initials': 'NR', 'LastName': 'Haycock', 'Affiliation': 'Department of Pain and Translational Symptom Science, School of Nursing, University of Maryland, Baltimore, Maryland, USA.'}, {'ForeName': 'Maxie', 'Initials': 'M', 'LastName': 'Blasini', 'Affiliation': 'Department of Pain and Translational Symptom Science, School of Nursing, University of Maryland, Baltimore, Maryland, USA.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Thomas', 'Affiliation': 'Department of Pain and Translational Symptom Science, School of Nursing, University of Maryland, Baltimore, Maryland, USA.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Phillips', 'Affiliation': 'Department of Neural and Pain Sciences, School of Dentistry, University of Maryland, Baltimore, Maryland, USA.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Corsi', 'Affiliation': 'Department of Pain and Translational Symptom Science, School of Nursing, University of Maryland, Baltimore, Maryland, USA.'}, {'ForeName': 'Lieven A', 'Initials': 'LA', 'LastName': 'Schenk', 'Affiliation': 'Department of Pain and Translational Symptom Science, School of Nursing, University of Maryland, Baltimore, Maryland, USA.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Pain and Translational Symptom Science, School of Nursing, University of Maryland, Baltimore, Maryland, USA.'}]",Psychotherapy and psychosomatics,['10.1159/000507400']
877,27262152,"Effectiveness of an Evidence-Based Quality Improvement Approach to Cultural Competence Training: The Veterans Affairs' ""Caring for Women Veterans"" Program.","INTRODUCTION


Although providing culturally sensitive health care is vitally important, there is little consensus regarding the most effective strategy for implementing cultural competence trainings in the health care setting. Evidence-based quality improvement (EBQI), which involves adapting evidence-based practices to meet local needs, may improve uptake and effectiveness of a variety of health care innovations. Yet, to our knowledge, EBQI has not yet been applied to cultural competence training. To evaluate whether EBQI could enhance the impact of an evidence-based training intended to improve veterans affairs health care staff gender sensitivity and knowledge (Caring for Women Veterans; CWV), we compared the reach and effectiveness of EBQI delivery versus standard web-based implementation strategies of CWV and assessed barriers and facilitators to EBQI implementation.
METHODS


Workgroups at four diverse veterans affairs health care sites were randomized to either an EBQI or standard web-based implementation condition (SI). All EBQI sites selected a group-based implementation strategy. Employees (N = 84) completed pretraining and posttraining assessments of gender sensitivity and knowledge, and focus groups/interviews were conducted with leadership and staff before and after implementation.
RESULTS


Reach of CWV was greater in the EBQI condition versus the SI condition. Whereas both gender sensitivity and knowledge improved in the EBQI condition, only gender sensitivity improved in the SI condition. Qualitative analyses revealed that the EBQI approach was well received, although a number of barriers were identified.
DISCUSSION


Findings suggest that EBQI can enhance the uptake and effectiveness of employee trainings. However, the decision to pursue EBQI must be informed by a consideration of available resources.",2016,"Whereas both gender sensitivity and knowledge improved in the EBQI condition, only gender sensitivity improved in the SI condition.",['Workgroups at four diverse veterans affairs health care sites'],"['EBQI', 'EBQI or standard web-based implementation condition (SI', 'Evidence-Based Quality Improvement Approach to Cultural Competence Training']",['gender sensitivity'],"[{'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C2936612', 'cui_str': 'Quality Improvement'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0679748', 'cui_str': 'Cultural Competence'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}]",84.0,0.0230788,"Whereas both gender sensitivity and knowledge improved in the EBQI condition, only gender sensitivity improved in the SI condition.","[{'ForeName': 'Annie B', 'Initials': 'AB', 'LastName': 'Fox', 'Affiliation': ""Dr. Fox: Research Health Science Specialist, Women's Health Sciences Division, National Center for Posttraumatic Stress Disorder, VA Boston Healthcare System, Boston, MA. Dr. Hamilton: Research Health Scientist, HSR&D Center for the Study of Healthcare Innovation, Implementation and Policy, VA Greater Los Angeles Healthcare System, Los Angeles, CA, and Department of Psychiatry and Biobehavioral Sciences, University of California Los Angeles, Los Angeles, CA. Dr. Frayne: Professor of Medicine, VA HSR&D Center for Innovation to Implementation (Ci2i), VA Palo Alto Healthcare System, Palo Alto, CA, and Division of General Medical Disciplines and Center for Primary Care and Outcomes Research, Stanford University, Stanford, CA. Dr. Wiltsey-Stirman: Research Psychologist, Women's Health Sciences Division, National Center for Posttraumatic Stress Disorder, VA Boston Healthcare System, Boston, MA, and Department of Psychiatry, Boston University School of Medicine, Boston, MA. Dr. Bean-Mayberry: VA HSR&D Investigator and Staff Physician, VA HSR&D Center for the Study of Healthcare Innovation, Implementation and Policy (CSHIIP), VA Greater Los Angeles Healthcare System, Los Angeles, CA, and Department of Medicine, University of California Los Angeles David Geffen School of Medicine, West Los Angeles, CA. Ms. Carney: Research Health Science Specialist, VA HSR&D Center for Innovation to Implementation (Ci2i), VA Palo Alto Health Care System, Palo Alto, CA. Dr. Di Leone: Postdoctoral Researcher, Center for Health Equity Research and Promotion, Philadelphia VA Medical Center, Philadelphia, PA. Dr. Gierisch: Assistant Professor, Center for Health Services Research in Primary Care, Durham VA Medical Center, Durham, NC, and Department of Medicine, Duke University School of Medicine, Durham, NC. Dr. Goldstein: Assistant Professor, Center for Health Services Research in Primary Care, Durham VA Medical Center, Durham, NC, and Division of General Internal Medicine, Duke University School""}, {'ForeName': 'Alison B', 'Initials': 'AB', 'LastName': 'Hamilton', 'Affiliation': ''}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Frayne', 'Affiliation': ''}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Wiltsey-Stirman', 'Affiliation': ''}, {'ForeName': 'Bevanne', 'Initials': 'B', 'LastName': 'Bean-Mayberry', 'Affiliation': ''}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Carney', 'Affiliation': ''}, {'ForeName': 'Brooke A L', 'Initials': 'BA', 'LastName': 'Di Leone', 'Affiliation': ''}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Gierisch', 'Affiliation': ''}, {'ForeName': 'Karen M', 'Initials': 'KM', 'LastName': 'Goldstein', 'Affiliation': ''}, {'ForeName': 'Yasmin', 'Initials': 'Y', 'LastName': 'Romodan', 'Affiliation': ''}, {'ForeName': 'Anne G', 'Initials': 'AG', 'LastName': 'Sadler', 'Affiliation': ''}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Yano', 'Affiliation': ''}, {'ForeName': 'Ellen F', 'Initials': 'EF', 'LastName': 'Yee', 'Affiliation': ''}, {'ForeName': 'Dawne', 'Initials': 'D', 'LastName': 'Vogt', 'Affiliation': ''}]",The Journal of continuing education in the health professions,['10.1097/CEH.0000000000000073']
878,31127757,"Effects of resistive jaw opening exercise in stroke patients with dysphagia: A double- blind, randomized controlled study.","BACKGROUND


The resistive jaw opening exercise (RJOE) was suggested as a potential remedial treatment for patients with dysphagia. However, clinical evidence is insufficient.
OBJECTIVE


To investigate the effect of RJOE on hyoid bone movement, aspiration, and oral intake level in stroke patients with dysphagia.
METHODS


Forty stroke patients with dysphagia were randomly allocated into either the experimental group (n= 20) or placebo group (n= 20). The experimental group performed RJOE using a portable device, while the placebo group performed RJOE using a sham device with fewer loads. Intervention was conducted 5 times a week for 4 weeks. Hyoid bone movement was analyzed by two-dimensional analysis of anterior and superior motion based on a videofluoroscopic swallowing study. Aspiration was assessed using a penetration-aspiration scale (PAS), and oral intake level was assessed using the functional oral intake scale (FOIS).
RESULTS


Both groups showed statistically significant differences in hyoid movement, PAS, and FOIS scale (p< 0.05). However, after the intervention, there was no significant difference between the two groups except for the liquid type of PAS. Effect sizes (Cohen's d) were 0.9 and 0.7, 0.6 and 0.6, and 1.1 for the anterior and superior movement of the hyoid bone, semisolid and liquid type of PAS, and FOIS scale respectively.
CONCLUSIONS


This study suggests that RJOE helps in hyoid movement, aspiration reduction, and oral intake in patients with dysphagia after stroke.",2020,"Both groups showed statistically significant differences in hyoid movement, PAS, and FOIS scale (p< 0.05).","['Forty stroke patients with dysphagia', 'patients with dysphagia', 'stroke patients with dysphagia', 'patients with dysphagia after stroke']","['resistive jaw opening exercise (RJOE', 'RJOE', 'placebo', 'resistive jaw opening exercise']","['Hyoid bone movement', 'hyoid movement, PAS, and FOIS scale', 'penetration aspiration scale (PAS), and oral intake level', 'hyoid bone movement, aspiration, and oral intake level', 'liquid type of PAS', 'hyoid bone, semisolid and liquid type of PAS, and FOIS scale respectively', 'functional oral intake scale (FOIS']","[{'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}]","[{'cui': 'C0022359', 'cui_str': 'Jaw'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0020417', 'cui_str': 'Lingual Bone'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0222045'}, {'cui': 'C0349707', 'cui_str': 'Aspiration - action (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1304698', 'cui_str': 'Liquid - descriptor'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]",40.0,0.152171,"Both groups showed statistically significant differences in hyoid movement, PAS, and FOIS scale (p< 0.05).","[{'ForeName': 'Ji-Su', 'Initials': 'JS', 'LastName': 'Park', 'Affiliation': 'Advanced Human Resource Development Project Group for Health Care in Aging Friendly Industry, Dongseo University, Busan, Korea.'}, {'ForeName': 'Duk-Hyun', 'Initials': 'DH', 'LastName': 'An', 'Affiliation': 'Department of Physical Therapy, College of Healthcare Medical Science and Engineering, Inje University, Gimhae, Korea.'}, {'ForeName': 'Kyung-Yoon', 'Initials': 'KY', 'LastName': 'Kam', 'Affiliation': 'Department of Occupational Therapy, College of Healthcare Medical Science and Engineering, Inje University, Gimhae, Korea.'}, {'ForeName': 'Taehyung', 'Initials': 'T', 'LastName': 'Yoon', 'Affiliation': 'Department of Occupational Therapy, Division of Health Sciences, Dongseo University, Busan, Korea.'}, {'ForeName': 'Taehoon', 'Initials': 'T', 'LastName': 'Kim', 'Affiliation': 'Department of Occupational Therapy, Division of Health Sciences, Dongseo University, Busan, Korea.'}, {'ForeName': 'Moon-Young', 'Initials': 'MY', 'LastName': 'Chang', 'Affiliation': 'Department of Occupational Therapy, College of Healthcare Medical Science and Engineering, Inje University, Gimhae, Korea.'}]",Journal of back and musculoskeletal rehabilitation,['10.3233/BMR-181477']
879,31561325,The effect of different exercise types on sedentary young women's lipid profile.,"BACKGROUND


Individualized exercise programs should be prepared according to duration and intensity.
OBJECTIVE


The current study focused on the effect of different types of exercises regularly done for eight weeks on sedentary young women's body components and lipid profile.
METHODS


The sample of the study was composed of 30 sedentary women recruited from Afyon Kocatepe University. The participants were randomly sorted into three groups and received combined exercises (aerobic + resistance exercises), aerobic exercises and cardio tennis exercises three days a week for eight weeks but no dietary program was given. Before and after the exercise programs, participants' body weights, heights, waist and hip circumferences were measured and their body components were analyzed through the bioelectrical impedance method. For the lipid profile analyses, 5 cc. of blood samples were drawn from forearm veins of the participants with the help of health specialists, and a biochemical doctor analyzed lipid profile markers such as total cholesterol, triglyceride, HDL, LDL, and VLDL.
RESULTS


It was found that exercises regularly done for eight weeks affected young women's body components considerably while it did not influence their lipid profile.
CONCLUSIONS


The effect on body components depended on time. No difference was found in terms of exercise type.",2020,"It was found that exercises regularly done for eight weeks affected young women's body components considerably while it did not influence their lipid profile.
","['30 sedentary women recruited from Afyon Kocatepe University', ""sedentary young women's body components and lipid profile"", ""sedentary young women's lipid profile""]","['combined exercises (aerobic + resistance exercises), aerobic exercises and cardio tennis exercises three days a week for eight weeks but no dietary program']","['total cholesterol, triglyceride, HDL, LDL, and VLDL']","[{'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0039515', 'cui_str': 'Tennis'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0523560', 'cui_str': 'VLDL cholesterol measurement'}]",30.0,0.0229038,"It was found that exercises regularly done for eight weeks affected young women's body components considerably while it did not influence their lipid profile.
","[{'ForeName': 'I', 'Initials': 'I', 'LastName': 'Yildirim', 'Affiliation': 'School of Physical Education and Sports, Mersin University, Mersin, Turkey.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Aydin Altinbas', 'Affiliation': 'School of Physical Education and Sports, Afyon Kocatepe University, Afyonkarahisar, Turkey.'}, {'ForeName': 'N B', 'Initials': 'NB', 'LastName': 'Demirezen', 'Affiliation': 'School of Physical Education and Sports, Afyon Kocatepe University, Afyonkarahisar, Turkey.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Dener', 'Affiliation': 'School of Physical Education and Sports, Afyon Kocatepe University, Afyonkarahisar, Turkey.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Sezgin', 'Affiliation': 'School of Physical Education and Sports, Afyon Kocatepe University, Afyonkarahisar, Turkey.'}]",Journal of back and musculoskeletal rehabilitation,['10.3233/BMR-181323']
880,27236082,Gender transition affects neural correlates of empathy: A resting state functional connectivity study with ultra high-field 7T MR imaging.,"Sex-steroid hormones have repeatedly been shown to influence empathy, which is in turn reflected in resting state functional connectivity (rsFC). Cross-sex hormone treatment in transgender individuals provides the opportunity to examine changes to rsFC over gender transition. We aimed to investigate whether sex-steroid hormones influence rsFC patterns related to unique aspects of empathy, namely emotion recognition and description as well as emotional contagion. RsFC data was acquired with 7Tesla magnetic resonance imaging in 24 male-to-female (MtF) and 33 female-to-male (FtM) transgender individuals before treatment, in addition to 33 male- and 44 female controls. Of the transgender participants, 15 MtF and 20 FtM were additionally assessed after 4 weeks and 4 months of treatment. Empathy scores were acquired at the same time-points. MtF differed at baseline from all other groups and assimilated over the course of gender transition in a rsFC network around the supramarginal gyrus, a region central to interpersonal emotion processing. While changes to sex-steroid hormones did not correlate with rsFC in this network, a sex hormone independent association between empathy scores and rsFC was found. Our results underline that 1) MtF transgender persons demonstrate unique rsFC patterns in a network related to empathy and 2) changes within this network over gender transition are likely related to changes in emotion recognition, -description, and -contagion, and are sex-steroid hormone independent.",2016,"MtF differed at baseline from all other groups and assimilated over the course of gender transition in a rsFC network around the supramarginal gyrus, a region central to interpersonal emotion processing.","['24 male-to-female (MtF) and 33 female-to-male (FtM) transgender individuals before treatment, in addition to 33 male- and 44 female controls']","['7Tesla magnetic resonance imaging', 'ultra high-field 7T MR imaging']","['empathy', 'Empathy scores']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0440042', 'cui_str': ""Field's""}]","[{'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.035457,"MtF differed at baseline from all other groups and assimilated over the course of gender transition in a rsFC network around the supramarginal gyrus, a region central to interpersonal emotion processing.","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Spies', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Austria.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Hahn', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Austria.'}, {'ForeName': 'G S', 'Initials': 'GS', 'LastName': 'Kranz', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Austria.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Sladky', 'Affiliation': 'MR Center of Excellence, Center for Medical Physics and Biomedical Engineering, Medical University of Vienna, Austria.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Kaufmann', 'Affiliation': 'Department of Gynecology and Obstetrics, Medical University of Vienna, Austria.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Hummer', 'Affiliation': 'MR Center of Excellence, Center for Medical Physics and Biomedical Engineering, Medical University of Vienna, Austria.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Ganger', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Austria.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Kraus', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Austria.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Winkler', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Austria.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Seiger', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Austria.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Comasco', 'Affiliation': 'Department of Neuroscience, Uppsala University, Sweden.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Windischberger', 'Affiliation': 'MR Center of Excellence, Center for Medical Physics and Biomedical Engineering, Medical University of Vienna, Austria.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Kasper', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Austria.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Lanzenberger', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Austria. Electronic address: rupert.lanzenberger@meduniwien.ac.at.'}]",NeuroImage,['10.1016/j.neuroimage.2016.05.060']
881,31907774,Home-Based Physical Activity and Diet Intervention to Improve Physical Function in Advanced Liver Disease: A Randomized Pilot Trial.,"INTRODUCTION


A decline in physical function is highly prevalent and a poor prognostic factor in cirrhosis. We assessed the benefits of a home-based physical activity program (HB-PAP) in patients with cirrhosis with a randomized pilot trial.
METHODS


All participants received a personal activity tracker to monitor daily activities and were given 12 g/day of an essential amino acid supplement. The HB-PAP intervention consisted of biweekly counseling sessions to increase physical activity for 12 weeks. Six-minute walk test (6MWT) and cardiopulmonary exercise testing (CPET) assessed changes in aerobic fitness. Different anthropometric measuring tools were used for skeletal muscle and adiposity assessment.
RESULTS


Seventeen patients (60% male; 29% nonalcoholic steatohepatitis/cryptogenic, 29% hepatitis C, 24% alcohol, 18% other) were randomized, 9 to HB-PAP group. There were no significant differences in MELD-sodium between HB-PAP and controls at baseline or after the 12-week intervention. By the end of study, there was a significant between-group difference in daily step count favoring the active group (2627 [992-4262], p = 0.001), with less sedentary patients in the active group (33-17% vs. 25-43%, p = 0.003). The 6MWT improved in the HB-PAP group (423 ± 26 m vs. 482 ± 35 m), while the controls had a nonsignificant drop (418 ± 26 m vs. 327 ± 74 m) with a significant between-group difference. CPET did not change. Other than an improvement in psoas muscle index, there were no differences in anthropometry, or in quality of life.
CONCLUSIONS


HB-PAP maintained physical performance and improved aerobic fitness according to 6MWT but not CPET, supporting the use of personal activity trackers to monitor/guide home-based prehabilitation programs in cirrhosis.",2020,"Other than an improvement in psoas muscle index, there were no differences in anthropometry, or in quality of life.
","['patients with cirrhosis with a randomized pilot trial', 'Seventeen patients (60% male; 29% nonalcoholic steatohepatitis/cryptogenic, 29% hepatitis C, 24% alcohol, 18% other) were randomized, 9 to HB-PAP group', 'Advanced Liver Disease']","['personal activity tracker to monitor daily activities and were given 12\xa0g/day of an essential amino acid supplement', 'CPET', 'home-based physical activity program (HB-PAP', 'Six-minute walk test (6MWT) and cardiopulmonary exercise testing (CPET', 'Home-Based Physical Activity and Diet Intervention']","['6MWT', 'psoas muscle index', 'quality of life', 'physical activity', 'daily step count', 'MELD-sodium', 'aerobic fitness']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1623038', 'cui_str': 'Cirrhosis'}, {'cui': 'C0473169', 'cui_str': 'Aviators'}, {'cui': 'C0450331', 'cui_str': '17 (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C3241937', 'cui_str': 'Nonalcoholic Steatohepatitis'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin) (qualifier value)'}, {'cui': 'C0019196', 'cui_str': 'Parenterally-Transmitted Non-A, Non-B Hepatitis'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0023895', 'cui_str': 'Disorder of liver (disorder)'}]","[{'cui': 'C4264352', 'cui_str': 'Activity Trackers'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C1318183', 'cui_str': '12G'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0002525', 'cui_str': 'Amino Acids, Essential'}, {'cui': 'C0055954', 'cui_str': 'CPET'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0012155', 'cui_str': 'Diet'}]","[{'cui': 'C0085221', 'cui_str': 'Psoas Muscles'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0034380'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}]",,0.064779,"Other than an improvement in psoas muscle index, there were no differences in anthropometry, or in quality of life.
","[{'ForeName': 'Hui Wei', 'Initials': 'HW', 'LastName': 'Chen', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, Thomas E. Starzl Transplantation Institute, University of Pittsburgh Medical Center, 3471 Fifth Avenue, Suite 201, Pittsburgh, PA, 15213, USA.'}, {'ForeName': 'Arny', 'Initials': 'A', 'LastName': 'Ferrando', 'Affiliation': 'Department of Geriatrics, Donald W. Reynolds Institute on Aging, University of Arkansas for Medical Sciences, Little Rock, AR, USA.'}, {'ForeName': 'Michelle G', 'Initials': 'MG', 'LastName': 'White', 'Affiliation': 'Division of Gastroenterology and Hepatology, University of Arkansas for Medical Sciences, Little Rock, AR, USA.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Dennis', 'Affiliation': 'Department of Geriatrics, Donald W. Reynolds Institute on Aging, University of Arkansas for Medical Sciences, Little Rock, AR, USA.'}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Xie', 'Affiliation': 'Division of Gastroenterology and Hepatology, University of Arkansas for Medical Sciences, Little Rock, AR, USA.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Pauly', 'Affiliation': 'Liver Transplant Program, University of Arkansas for Medical Sciences, Little Rock, AR, USA.'}, {'ForeName': 'Sanghee', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': 'Department of Geriatrics, Donald W. Reynolds Institute on Aging, University of Arkansas for Medical Sciences, Little Rock, AR, USA.'}, {'ForeName': 'Thaddeus', 'Initials': 'T', 'LastName': 'Bartter', 'Affiliation': 'Division of Pulmonary Medicine, University of Arkansas for Medical Sciences, Little Rock, AR, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Dunn', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, Thomas E. Starzl Transplantation Institute, University of Pittsburgh Medical Center, 3471 Fifth Avenue, Suite 201, Pittsburgh, PA, 15213, USA.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Ruiz-Margain', 'Affiliation': 'Department of Gastroenterology, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'W Ray', 'Initials': 'WR', 'LastName': 'Kim', 'Affiliation': 'Division of Gastroenterology and Hepatology, Stanford University, Palo Alto, CA, USA.'}, {'ForeName': 'Andres', 'Initials': 'A', 'LastName': 'Duarte-Rojo', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, Thomas E. Starzl Transplantation Institute, University of Pittsburgh Medical Center, 3471 Fifth Avenue, Suite 201, Pittsburgh, PA, 15213, USA. duarterojoa@upmc.edu.'}]",Digestive diseases and sciences,['10.1007/s10620-019-06034-2']
882,31383238,"Improving Daytime Functioning, Work Performance, and Quality of Life in Postmenopausal Women With Insomnia: Comparing Cognitive Behavioral Therapy for Insomnia, Sleep Restriction Therapy, and Sleep Hygiene Education.","STUDY OBJECTIVES


Insomnia is a chief complaint among postmenopausal women, and insomnia impairs daytime functioning and reduces quality of life. Recent evidence supports the efficacy of cognitive behavioral therapy for insomnia (CBTI) for menopausal insomnia, but it remains unclear whether treating insomnia improves daytime function in this population. This study evaluated whether CBTI improves daytime fatigue, energy, self-reported sleepiness, work productivity, and quality of life in postmenopausal women with insomnia, and whether sleep restriction therapy (SRT)-a single component of CBTI-is equally efficacious.
METHODS


Single-site, randomized control trial. One hundred fifty postmenopausal women (56.44 ± 5.64 years) with perimenopausal or postmenopausal onset or exacerbation of chronic insomnia were randomized to 3 treatment conditions: sleep hygiene education control (SHE), SRT, and CBTI. Blinded assessments were performed at pretreatment, posttreatment, and 6-month follow-up.
RESULTS


CBTI and SRT produced moderate-to-large improvements in fatigue, energy, sleepiness, and work function at posttreatment and 6 months later. The CBTI group reported better quality of life as indicated by substantial improvements in emotional wellbeing and resiliency to physical and emotional problems, whereas the SRT and SHE groups only showed improvements in resiliency to physical problems. Pain complaints decreased as sleep improved but were not associated with specific treatment conditions. Similarly, insomnia remitters reported fewer daytime and nighttime hot flashes, although reductions were not associated with any specific treatment.
CONCLUSIONS


CBTI and SRT are efficacious options for postmenopausal women with chronic insomnia. Both interventions improve daytime function, quality of life, and work performance, although CBTI produces superior results including the added benefit of improved emotional health.
CLINICAL TRIAL REGISTRATION


Registry: ClinicalTrials.gov; Title: Behavioral Treatment of Menopausal Insomnia; Sleep and Daytime Outcomes; Identifier: NCT01933295; URL: https://clinicaltrials.gov/ct2/show/record/NCT01933295.",2019,"RESULTS


CBTI and SRT produced moderate-to-large improvements in fatigue, energy, sleepiness, and work function at posttreatment and 6 months later.","['postmenopausal women with chronic insomnia', 'One hundred fifty postmenopausal women (56.44 ± 5.64 years) with perimenopausal or postmenopausal onset or exacerbation of chronic insomnia', 'postmenopausal women with insomnia', 'Postmenopausal Women With Insomnia']","['3 treatment conditions: sleep hygiene education control (SHE), SRT, and CBTI', 'Cognitive Behavioral Therapy', 'CBTI and SRT', 'sleep restriction therapy (SRT)-a single component of CBTI', 'CBTI', 'cognitive behavioral therapy']","['daytime fatigue, energy, self-reported sleepiness, work productivity, and quality of life', 'Pain complaints', 'daytime and nighttime hot flashes', 'daytime function, quality of life, and work performance', 'Improving Daytime Functioning, Work Performance, and Quality of Life', 'emotional wellbeing and resiliency to physical and emotional problems', 'quality of life', 'fatigue, energy, sleepiness, and work function', 'Insomnia, Sleep Restriction Therapy, and Sleep Hygiene Education']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0751249', 'cui_str': 'Chronic Insomnia'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3839366', 'cui_str': 'Perimenopausal state (finding)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C4277672', 'cui_str': 'Sleep Hygiene'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0234742', 'cui_str': 'Speech reception threshold (observable entity)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C2584987', 'cui_str': 'Sleep restriction therapy (regime/therapy)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}]","[{'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0034380'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0277786', 'cui_str': 'Presenting complaint'}, {'cui': 'C0600142', 'cui_str': 'Hot Flashes'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1286385', 'cui_str': 'Performance at Work'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0677660', 'cui_str': 'Emotional problems (finding)'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C2584987', 'cui_str': 'Sleep restriction therapy (regime/therapy)'}, {'cui': 'C4277672', 'cui_str': 'Sleep Hygiene'}, {'cui': 'C0013621', 'cui_str': 'Education'}]",150.0,0.064667,"RESULTS


CBTI and SRT produced moderate-to-large improvements in fatigue, energy, sleepiness, and work function at posttreatment and 6 months later.","[{'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Kalmbach', 'Affiliation': 'Thomas Roth Sleep Disorders and Research Center, Henry Ford Health System, Detroit, Michigan.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Cheng', 'Affiliation': 'Thomas Roth Sleep Disorders and Research Center, Henry Ford Health System, Detroit, Michigan.'}, {'ForeName': 'J Todd', 'Initials': 'JT', 'LastName': 'Arnedt', 'Affiliation': 'Department of Psychiatry, University of Michigan Medical School, Ann Arbor, Michigan.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Cuamatzi-Castelan', 'Affiliation': 'Thomas Roth Sleep Disorders and Research Center, Henry Ford Health System, Detroit, Michigan.'}, {'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'Atkinson', 'Affiliation': 'Thomas Roth Sleep Disorders and Research Center, Henry Ford Health System, Detroit, Michigan.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Fellman-Couture', 'Affiliation': 'Thomas Roth Sleep Disorders and Research Center, Henry Ford Health System, Detroit, Michigan.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Roehrs', 'Affiliation': 'Thomas Roth Sleep Disorders and Research Center, Henry Ford Health System, Detroit, Michigan.'}, {'ForeName': 'Christopher L', 'Initials': 'CL', 'LastName': 'Drake', 'Affiliation': 'Thomas Roth Sleep Disorders and Research Center, Henry Ford Health System, Detroit, Michigan.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.7882']
883,32419473,Lenvatinib versus sorafenib for unresectable hepatocellular carcinoma: a cost-effectiveness analysis.,"Aim:  To investigate the cost-effectiveness of lenvatinib and sorafenib in the treatment of patients with nonresected hepatocellular carcinoma in China.  Materials & methods:  Markov model was used to simulate the direct medical cost and quality-adjusted life years (QALY) of patients with hepatocellular carcinoma. Clinical data were derived from the Phase 3 randomized clinical trial in a Chinese population.  Results:  Sorafenib treatment resulted in 1.794 QALYs at a cost of $43,780.73. Lenvatinib treatment resulted in 2.916 QALYs for patients weighing <60 and ≥60 kg at a cost of $57,049.43 and $75,900.36, The incremental cost-effectiveness ratio to the sorafenib treatment group was $11,825.94/QALY and $28,627.12/QALY, respectively.  Conclusion:  According to WHO's triple GDP per capita, the use of lenvatinib by providing drugs is a cost-effective strategy.",2020,"Lenvatinib treatment resulted in 2.916 QALYs for patients weighing <60 and ≥60 kg at a cost of $57,049.43 and $75,900.36, The incremental cost-effectiveness ratio to the sorafenib treatment group was $11,825.94/QALY and $28,627.12/QALY, respectively.  ","['unresectable hepatocellular carcinoma', 'patients with nonresected hepatocellular carcinoma in China', 'patients with hepatocellular carcinoma']","['lenvatinib and sorafenib', 'Lenvatinib versus sorafenib', 'Sorafenib']","['incremental cost-effectiveness ratio', 'direct medical cost and quality-adjusted life years (QALY']","[{'cui': 'C1112459', 'cui_str': 'Liver cell carcinoma non-resectable'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C2986924', 'cui_str': 'lenvatinib'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}]",,0.0749662,"Lenvatinib treatment resulted in 2.916 QALYs for patients weighing <60 and ≥60 kg at a cost of $57,049.43 and $75,900.36, The incremental cost-effectiveness ratio to the sorafenib treatment group was $11,825.94/QALY and $28,627.12/QALY, respectively.  ","[{'ForeName': 'Hongfu', 'Initials': 'H', 'LastName': 'Cai', 'Affiliation': 'Department of Pharmacy, Fujian Medical University Union Hospital, Fuzhou, Fujian Province, China.'}, {'ForeName': 'Longfeng', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Medical Oncology, Fujian Provincial Cancer Hospital, Fuzhou, Fujian Province, China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'Department of Pharmacy, Fujian Medical University Union Hospital, Fuzhou, Fujian Province, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Zheng', 'Affiliation': 'Department of Pharmacy, Fujian Medical University Union Hospital, Fuzhou, Fujian Province, China.'}, {'ForeName': 'Maobai', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'Department of Pharmacy, Fujian Medical University Union Hospital, Fuzhou, Fujian Province, China.'}]",Journal of comparative effectiveness research,['10.2217/cer-2020-0041']
884,27075273,Incorporating Inter-Professional Education into a Veterinary Medical Curriculum.,"Inter-professional education (IPE) is identified as an important component of health profession training and is listed in the accreditation requirements for many fields, including veterinary medicine. The goals of IPE are to develop inter-professional skills and to improve patient-oriented care and community health outcomes. To meet these goals, IPE relies on enhanced teamwork, a high level of communication, mutual planning, collective decision making, and shared responsibilities. One Health initiatives have also become integral parts of core competencies for veterinary curricular development. While the overall objectives of an IPE program are similar to those of a One Health initiative, they are not identical. There are unique differences in expectations and outcomes for an IPE program. The purpose of this study was to explore veterinary medical students' perceptions of their interprofessional experiences following participation in a required IPE course that brought together beginning health profession students from the colleges of medicine, dentistry, nursing, pharmacy, nutrition, public health and health professions, and veterinary medicine. Using qualitative research methods, we found that there is powerful experiential learning that occurs for both the veterinary students and the other health profession students when they work together at the beginning of their curriculum as an inter-professional team.",2016,"Using qualitative research methods, we found that there is powerful experiential learning that occurs for both the veterinary students and the other health profession students when they work together at the beginning of their curriculum as an inter-professional team.","[""veterinary medical students' perceptions of their interprofessional experiences following participation in a required IPE course that brought together beginning health profession students from the colleges of medicine, dentistry, nursing, pharmacy, nutrition, public health and health professions, and veterinary medicine""]",['Inter-professional education (IPE'],[],"[{'cui': 'C0042614', 'cui_str': 'veterinary'}, {'cui': 'C0038495', 'cui_str': 'Students, Medical'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C1704312', 'cui_str': 'Healthcare professional (occupation)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0011438', 'cui_str': 'Dentistry'}, {'cui': 'C0028678', 'cui_str': 'nursing care'}, {'cui': 'C0031322', 'cui_str': 'Pharmacies'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0042615', 'cui_str': 'Veterinary Medicine'}]","[{'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0013647', 'cui_str': 'Education, Professional'}]",[],1.0,0.0230972,"Using qualitative research methods, we found that there is powerful experiential learning that occurs for both the veterinary students and the other health profession students when they work together at the beginning of their curriculum as an inter-professional team.","[{'ForeName': 'Amara H', 'Initials': 'AH', 'LastName': 'Estrada', 'Affiliation': ''}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Behar-Horenstein', 'Affiliation': ''}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Estrada', 'Affiliation': ''}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Black', 'Affiliation': ''}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Kwiatkowski', 'Affiliation': ''}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Bzoch', 'Affiliation': ''}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Blue', 'Affiliation': ''}]",Journal of veterinary medical education,['10.3138/jvme.0715-121R']
885,32026447,Relationship of White Matter Lesions with Intracerebral Hemorrhage Expansion and Functional Outcome: MISTIE II and CLEAR III.,"BACKGROUND/OBJECTIVE


Intracerebral hemorrhage (ICH) patients commonly have concomitant white matter lesions (WML) which may be associated with poor outcome. We studied if WML affects hematoma expansion (HE) and post-stroke functional outcome in a post hoc analysis of patients from randomized controlled trials.
METHODS


In ICH patients from the clinical trials MISTIE II and CLEAR III, WML grade on diagnostic computed tomography (dCT) scan (dCT, < 24 h after ictus) was assessed using the van Swieten scale (vSS, range 0-4). The primary outcome for HE was > 33% or > 6 mL ICH volume increase from dCT to the last pre-randomization CT (< 72 h of dCT). Secondary HE outcomes were: absolute ICH expansion, > 10.4 mL total clot volume increase, and a subgroup analysis including patients with dCT < 6 h after ictus using the primary HE definition of > 33% or > 6 mL ICH volume increase. Poor functional outcome was assessed at 180 days and defined as modified Rankin Scale (mRS) ≥ 4, with ordinal mRS as a secondary endpoint.
RESULTS


Of 635 patients, 55% had WML grade 1-4 at dCT (median 2.2 h from ictus) and 13% had subsequent HE. WML at dCT did not increase the odds for primary or secondary HE endpoints (P ≥ 0.05) after adjustment for ICH volume, intraventricular hemorrhage volume, warfarin/INR > 1.5, ictus to dCT time in hours, age, diabetes mellitus, and thalamic ICH location. WML increased the odds for having poor functional outcome (mRS ≥ 4) in univariate analyses (vSS 4; OR 4.16; 95% CI 2.54-6.83; P < 0.001) which persisted in multivariable analyses after adjustment for HE and other outcome risk factors.
CONCLUSIONS


Concomitant WML does not increase the odds for HE in patients with ICH but increases the odds for poor functional outcome.
CLINICAL TRIAL REGISTRATION


http://www.clinicaltrials.gov trial-identifiers: NCT00224770 and NCT00784134.",2020,"WML at dCT did not increase the odds for primary or secondary HE endpoints (P ≥ 0.05) after adjustment for ICH volume, intraventricular hemorrhage volume, warfarin/INR > 1.5, ictus to dCT time in hours, age, diabetes mellitus, and thalamic ICH location.",['patients with dCT'],['WML'],"['absolute ICH expansion, ', 'ICH volume, intraventricular hemorrhage volume, warfarin/INR\u2009>\u20091.5, ictus to dCT time in hours, age, diabetes mellitus, and thalamic ICH location', 'Poor functional outcome']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]",[],"[{'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0240059', 'cui_str': 'Ventricular hemorrhage (disorder)'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0525032', 'cui_str': 'INR'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0450429', 'cui_str': 'Location (attribute)'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]",635.0,0.141451,"WML at dCT did not increase the odds for primary or secondary HE endpoints (P ≥ 0.05) after adjustment for ICH volume, intraventricular hemorrhage volume, warfarin/INR > 1.5, ictus to dCT time in hours, age, diabetes mellitus, and thalamic ICH location.","[{'ForeName': 'Björn M', 'Initials': 'BM', 'LastName': 'Hansen', 'Affiliation': 'Department of Clinical Sciences Lund, Neurology, Skåne University Hospital, Lund University, Lund, Sweden.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Ullman', 'Affiliation': ""Division of Neurology, The Children's Hospital of Philadelphia, Philadelphia, PA, USA. nlullman@gmail.com.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Muschelli', 'Affiliation': 'Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Norrving', 'Affiliation': 'Department of Clinical Sciences Lund, Neurology, Skåne University Hospital, Lund University, Lund, Sweden.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Dlugash', 'Affiliation': 'Division of Brain Injury Outcomes, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Radhika', 'Initials': 'R', 'LastName': 'Avadhani', 'Affiliation': 'Division of Brain Injury Outcomes, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Issam', 'Initials': 'I', 'LastName': 'Awad', 'Affiliation': 'Department of Neurosurgery, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Zuccarello', 'Affiliation': 'Department of Neurosurgery, University of Cincinnati, Cincinnati, OH, USA.'}, {'ForeName': 'Wendy C', 'Initials': 'WC', 'LastName': 'Ziai', 'Affiliation': 'Division of Brain Injury Outcomes, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'Hanley', 'Affiliation': 'Division of Brain Injury Outcomes, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Thompson', 'Affiliation': 'Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Lindgren', 'Affiliation': 'Department of Clinical Sciences Lund, Neurology, Skåne University Hospital, Lund University, Lund, Sweden.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Neurocritical care,['10.1007/s12028-020-00916-4']
886,31556447,Benefit-Finding Intervention Delivered Individually to Alzheimer Family Caregivers: Longer-Term Outcomes of a Randomized Double-Blind Controlled Trial.,"OBJECTIVES


To examine the longer-term effects of benefit-finding on caregivers' depressive symptoms (primary outcome), and global burden, role overload, psychological well-being, and positive aspects of caregiving (secondary outcomes).
METHOD


Ninety-six Hong Kong Chinese caregivers of relatives with Alzheimer's disease were randomly assigned to receive the benefit-finding intervention (BFT) or one of the two control conditions, namely, simplified psychoeducation (lectures only; SIM-PE) or standard psychoeducation (STD-PE). Caregivers received four biweekly one-to-one interventions of 3 hours each at their own homes. We focused on outcomes measured at 4- and 10-month follow-ups. The trajectories of intervention effects were modeled by BFT × time and BFT × time2 interaction terms.
RESULTS


Mixed-effects regression showed significant BFT × time2 interaction effects on depressive symptoms against both control conditions, suggesting diminishing BFT effects over time. Z tests showed that, compared with controls, BFT participants reported substantial reductions in depressive symptoms at 4-month follow-up (d = -0.85 and -0.75 vs. SIM-PE and STD-PE, respectively). For depressive symptoms measured at 10-month follow-up, BFT was indistinguishable from STD-PE, whereas a moderate effect was observed in comparison with SIM-PE (d = -0.52). Moreover, positive aspects of caregiving, but not other secondary outcomes, continued to show intervention effect up to 10-month follow-up.
DISCUSSION


Benefit-finding is an efficacious intervention for depressive symptoms in Alzheimer caregivers, with strong effects in the medium-term post-intervention and possible moderate effects in the longer-term post-intervention.",2020,"For depressive symptoms measured at 10-month follow-up, BFT was indistinguishable from STD-PE whereas a moderate effect was observed in the comparison with SIM-PE (d=-0.52).","[""96 Hong Kong Chinese caregivers of relatives with Alzheimer's disease"", 'Alzheimer Family Caregivers']","['benefit-finding intervention (BFT) or one of two control conditions, namely, simplified psychoeducation (lectures only; SIM-PE) or standard psychoeducation (STD-PE']","['BFT effects', ""caregivers' depressive symptoms (primary outcome), and global burden, role overload, psychological well-being, and positive aspects of caregiving (secondary outcomes"", 'depressive symptoms']","[{'cui': 'C0019907', 'cui_str': 'Hongkong'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}]","[{'cui': 'C2607943', 'cui_str': 'findings'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0871175', 'cui_str': 'Psycho-education'}, {'cui': 'C0376683', 'cui_str': 'Lecture'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}]",,0.474899,"For depressive symptoms measured at 10-month follow-up, BFT was indistinguishable from STD-PE whereas a moderate effect was observed in the comparison with SIM-PE (d=-0.52).","[{'ForeName': 'Sheung-Tak', 'Initials': 'ST', 'LastName': 'Cheng', 'Affiliation': 'Department of Health and Physical Education, The Education University of Hong Kong, Hong Kong.'}, {'ForeName': 'Emily P M', 'Initials': 'EPM', 'LastName': 'Mak', 'Affiliation': 'Department of Health and Physical Education, The Education University of Hong Kong, Hong Kong.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Kwok', 'Affiliation': 'Department of Medicine and Therapeutics, Hong Kong.'}, {'ForeName': 'Helene', 'Initials': 'H', 'LastName': 'Fung', 'Affiliation': 'Department of Psychology, Hong Kong.'}, {'ForeName': 'Linda C W', 'Initials': 'LCW', 'LastName': 'Lam', 'Affiliation': 'Department of Psychiatry, The Chinese University of Hong Kong, Hong Kong.'}]","The journals of gerontology. Series B, Psychological sciences and social sciences",['10.1093/geronb/gbz118']
887,31899340,Cycle Training improves vascular function and neuropathic symptoms in patients with type 2 diabetes and peripheral neuropathy: A randomized controlled trial.,"Diabetic peripheral neuropathy (DPN) is associated with peripheral arterial disease and endothelial dysfunction. We investigated the effect of exercise training on the measures of superficial femoral artery (SFA) and neuropathic symptoms in patients with DPN. In a randomized-controlled trial, 31 volunteers with established DPN were randomly assigned to experimental or control groups. Experimental group performed cycling exercise training (50%-70% of heart rate reserve, 30-45 min, 3 sessions/week) over 12 weeks. Before and 48 h after the experimental period a 5-min flow mediated dilation (FMD) response in SFA using Color Doppler Ultrasonography, fasting glucose level, HbA1c and neuropathic score were assessed. FMD% significantly increased in the experimental group (from 3.2 ± 1.1% to 5.7 ± 1.2%) compared to the control condition (P = 0.0001). However, no significant alteration occurred in baseline membrane diameter and intima media thickness (P > 0.05). We also observed a significant improvement in fasting glucose, HbA1c and Michigan Diabetic Neuropathy Score (MDNS) following exercise intervention (all P < 0.05). Linear regression analysis indicated that the change in MDNS was significantly associated with the change in HbA1c (R Square = 0.34, standardized coefficients Beta = -0.58, P = .001) and FMD (R Square = 0.37, standardized coefficients Beta = 0.61, P = .001). This finding may be clinically of considerable importance as metabolic and vascular factors have been indicated to be involved in the development of DPN.",2020,FMD% significantly increased in the experimental group (from 3.2 ± 1.1% to 5.7 ± 1.2%) compared to the control condition (P = 0.0001).,"['patients with DPN', '31 volunteers with established DPN', 'patients with type 2 diabetes and peripheral neuropathy']","['Cycle exercise', 'exercise training']","['fasting glucose, HbA1c and Michigan Diabetic Neuropathy Score (MDNS', 'resting baseline diameter and intima media thickness', 'MDNS and FMD', '5-min flow mediated dilation (FMD) response in SFA using Color Doppler Ultrasonography, fasting glucose level, HbA1c and neuropathic score', 'Diabetic peripheral neuropathy (DPN', 'FMD', 'superficial femoral artery (SFA) and neuropathic symptoms', 'vascular function and neuropathic symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0027270', 'cui_str': 'Nicotinamide adenine dinucleotide (NAD)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0031117', 'cui_str': 'PNS (Peripheral Nervous System) Diseases'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0025939', 'cui_str': 'Michigan'}, {'cui': 'C0011882', 'cui_str': 'Diabetic Neuropathies'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0162864', 'cui_str': 'Vascular Intima'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0242844', 'cui_str': 'Ultrasonography, Doppler, Color'}, {'cui': 'C0428548', 'cui_str': 'Glucose level - finding'}, {'cui': 'C0740447', 'cui_str': 'Peripheral neuropathy co-occurrent and due to diabetes mellitus'}, {'cui': 'C0027270', 'cui_str': 'Nicotinamide adenine dinucleotide (NAD)'}, {'cui': 'C0447106', 'cui_str': 'Superficial femoral artery (body structure)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}]",31.0,0.217646,FMD% significantly increased in the experimental group (from 3.2 ± 1.1% to 5.7 ± 1.2%) compared to the control condition (P = 0.0001).,"[{'ForeName': 'Farhad', 'Initials': 'F', 'LastName': 'Gholami', 'Affiliation': 'Department of Exercise Physiology, Faculty of Sports Sciences, Shahrood University of Technology, Shahrood, Iran. Electronic address: gholami-fa@shahroodut.ac.ir.'}, {'ForeName': 'Hamieh', 'Initials': 'H', 'LastName': 'Nazari', 'Affiliation': 'Department of Exercise Physiology, Faculty of Sports Sciences, Shahrood University of Technology, Shahrood, Iran.'}, {'ForeName': 'Milad', 'Initials': 'M', 'LastName': 'Alimi', 'Affiliation': 'Alejalil Hospital, Aq Qala, Golestan, Iran.'}]",Experimental gerontology,['10.1016/j.exger.2019.110799']
888,32017092,Consumption of Lactobacillus reuteri-containing lozenges improves periodontal health in navy sailors at sea: A randomized controlled trial.,"BACKGROUND


The objective of this trial was to evaluate whether the regular consumption of probiotics may improve the known deterioration of periodontal health in navy sailors during deployments at sea.
METHODS


72 healthy sailors of a naval ship on a practicing mission at sea were recruited and randomly provided with a blinded supply of lozenges to be consumed twice daily for the following 42 days containing either the probiotic strains Lactobacillus reuteri (DSM 17938 and L. reuteri (ATTC PTA 5289) (test n = 36) or no probiotics (placebo n = 36). At baseline, at day 14 and day 42 bleeding on probing (primary outcome), gingival index, plaque control record, probing attachment level, and probing pocket depth were assessed at the Ramfjord teeth.
RESULTS


At baseline there were no significant differences between the groups. At day 14 and day 42 test group scores of all assessed parameters were significantly improved (P < 0.001) compared to baseline and to the placebo group which by contrast showed a significant (P < 0.001) deterioration of all parameters at the end of the study.
CONCLUSIONS


The consumption of probiotic L. reuteri-lozenges is an efficacious measure to improve and maintain periodontal health in situations with waning efficacy of personal oral hygiene.",2020,"At day 14 and day 42 test group scores of all assessed parameters were significantly improved (p<0.001) compared to baseline and to the placebo group which by contrast showed a significant (p<0.001) deterioration of all parameters at the end of the study.
","['72 healthy sailors of a naval ship on a practicing mission at sea', 'navy sailors at sea', 'navy sailors during deployments at sea']","['placebo', 'probiotic strains Lactobacillus reuteri (DSM 17938 and L. reuteri (ATTC PTA 5289) (test n = 36) or no probiotics (placebo', 'Lactobacillus reuteri-containing lozenges']","['gingival index, plaque control record, probing attachment level and probing pocket depth', 'periodontal health']","[{'cui': 'C0524646', 'cui_str': 'Sailors'}, {'cui': 'C0036971', 'cui_str': 'Ships'}, {'cui': 'C0026219', 'cui_str': 'Missions'}, {'cui': 'C0036493', 'cui_str': 'Sea (environment)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C0317625', 'cui_str': 'Lactobacillus reuteri'}, {'cui': 'C0015522', 'cui_str': 'Factor Eleven'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C4319836', 'cui_str': 'Lozenge'}]","[{'cui': 'C0017569', 'cui_str': 'Gingival Index'}, {'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C3179165', 'cui_str': 'Probe (methazole)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",72.0,0.280807,"At day 14 and day 42 test group scores of all assessed parameters were significantly improved (p<0.001) compared to baseline and to the placebo group which by contrast showed a significant (p<0.001) deterioration of all parameters at the end of the study.
","[{'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Schlagenhauf', 'Affiliation': 'Department of Periodontology, University Hospital Würzburg, Würzburg, Germany.'}, {'ForeName': 'Juliane', 'Initials': 'J', 'LastName': 'Rehder', 'Affiliation': 'German Naval Medical Institute, Kronshagen, Germany.'}, {'ForeName': 'Götz', 'Initials': 'G', 'LastName': 'Gelbrich', 'Affiliation': 'Institute of Clinical Epidemiology and Biometry, University of Würzburg, Würzburg, Germany.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Jockel-Schneider', 'Affiliation': 'Department of Periodontology, University Hospital Würzburg, Würzburg, Germany.'}]",Journal of periodontology,['10.1002/JPER.19-0393']
889,31594858,Relationships between  DMD  mutations and neurodevelopment in dystrophinopathy.,"OBJECTIVE


We performed a prospective, cross-sectional analysis of neurodevelopmental concerns and psychosocial adjustment in relation to  DMD  mutations in young steroid-naive boys with dystrophinopathy.
METHODS


We evaluated 196 steroid-naive boys with dystrophinopathy who were enrolled in the Finding the Optimal Regimen for Duchenne Muscular Dystrophy trial. The neurodevelopmental concerns and psychosocial adjustment challenges were analyzed in relation to  DMD  mutation. A parent or legal guardian reported neurodevelopmental concerns in 4 domains (speech, learning and attentional difficulties, and autism spectrum disorder [ASD]) and completed the Personal Adjustment and Role Skills Scale to assess psychosocial adjustment. We also assessed whether boys of  DMD  carrier mothers were more vulnerable to speech delay and learning difficulties.
RESULTS


We found that 39% of boys were reported to have speech delay with a mean age of speaking at 28 months (range 7-66 months). Learning difficulties were reported in 28% of participants. Inattentive-overactive and oppositional-defiant behavior was reported in 8% and 5% of participants, respectively. Psychosocial adjustment challenges were reported in 4% of participants. An ASD diagnosis was reported in 3 participants. Speech delay and learning difficulties were more common in boys with mutations downstream of  DMD  exon 45. Neurodevelopmental concerns were not associated with  DMD  deletion, duplication, or point mutation subtype. Boys of  DMD  carrier mothers did not have longer speech delay or more learning difficulties.
CONCLUSION


Our data support evidence for a relationship between neurodevelopmental concerns and  DMD  mutation. A longitudinal assessment of developmental trajectory is necessary to evaluate how specific  DMD  mutations affect brain function.",2019,Speech delay and learning difficulties were more common in boys with mutations downstream of  ,"['196 steroid-naive boys with dystrophinopathy who were enrolled in the Finding the Optimal Regimen for Duchenne Muscular Dystrophy trial', 'young steroid-naive boys with dystrophinopathy', 'boys with mutations downstream of']",[],"['Learning difficulties', 'Psychosocial adjustment challenges', 'Speech delay and learning difficulties', 'Inattentive-overactive and oppositional-defiant behavior']","[{'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C2607943', 'cui_str': 'findings'}, {'cui': 'C0013264', 'cui_str': 'Cardiomyopathy, Dilated, X-Linked'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C0522506', 'cui_str': 'Downstream (qualifier value)'}]",[],"[{'cui': 'C0424939', 'cui_str': 'Learning difficulties (finding)'}, {'cui': 'C0456081', 'cui_str': 'Adjustment (procedure)'}, {'cui': 'C0241210', 'cui_str': 'Speech Delay'}, {'cui': 'C0443272', 'cui_str': 'Overactive (qualifier value)'}, {'cui': 'C0860661', 'cui_str': 'Oppositional'}, {'cui': 'C0424348', 'cui_str': 'Defiant behavior (finding)'}]",,0.0322319,Speech delay and learning difficulties were more common in boys with mutations downstream of  ,"[{'ForeName': 'Mathula', 'Initials': 'M', 'LastName': 'Thangarajh', 'Affiliation': ""From the Department of Neurology (M.T.), Children's National Health System, Washington, DC; Kempenhaeghe Center for Neurological Learning Disabilities (J.H.), Heeze, the Netherlands; and School of Medicine and Dentistry (M.P.M., W.M., K.A.H., R.C.G.), University of Rochester Medical Center, NY. M.T. is currently affiliated with the Department of Neurology, Virginia Commonwealth University, Richmond. mathula.thangarajh@vcuhealth.org.""}, {'ForeName': 'Jos', 'Initials': 'J', 'LastName': 'Hendriksen', 'Affiliation': ""From the Department of Neurology (M.T.), Children's National Health System, Washington, DC; Kempenhaeghe Center for Neurological Learning Disabilities (J.H.), Heeze, the Netherlands; and School of Medicine and Dentistry (M.P.M., W.M., K.A.H., R.C.G.), University of Rochester Medical Center, NY. M.T. is currently affiliated with the Department of Neurology, Virginia Commonwealth University, Richmond.""}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'McDermott', 'Affiliation': ""From the Department of Neurology (M.T.), Children's National Health System, Washington, DC; Kempenhaeghe Center for Neurological Learning Disabilities (J.H.), Heeze, the Netherlands; and School of Medicine and Dentistry (M.P.M., W.M., K.A.H., R.C.G.), University of Rochester Medical Center, NY. M.T. is currently affiliated with the Department of Neurology, Virginia Commonwealth University, Richmond.""}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Martens', 'Affiliation': ""From the Department of Neurology (M.T.), Children's National Health System, Washington, DC; Kempenhaeghe Center for Neurological Learning Disabilities (J.H.), Heeze, the Netherlands; and School of Medicine and Dentistry (M.P.M., W.M., K.A.H., R.C.G.), University of Rochester Medical Center, NY. M.T. is currently affiliated with the Department of Neurology, Virginia Commonwealth University, Richmond.""}, {'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Hart', 'Affiliation': ""From the Department of Neurology (M.T.), Children's National Health System, Washington, DC; Kempenhaeghe Center for Neurological Learning Disabilities (J.H.), Heeze, the Netherlands; and School of Medicine and Dentistry (M.P.M., W.M., K.A.H., R.C.G.), University of Rochester Medical Center, NY. M.T. is currently affiliated with the Department of Neurology, Virginia Commonwealth University, Richmond.""}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Griggs', 'Affiliation': ""From the Department of Neurology (M.T.), Children's National Health System, Washington, DC; Kempenhaeghe Center for Neurological Learning Disabilities (J.H.), Heeze, the Netherlands; and School of Medicine and Dentistry (M.P.M., W.M., K.A.H., R.C.G.), University of Rochester Medical Center, NY. M.T. is currently affiliated with the Department of Neurology, Virginia Commonwealth University, Richmond.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Neurology,['10.1212/WNL.0000000000008363']
890,26428452,Promoting Tdap immunization in pregnancy: Associations between maternal perceptions and vaccination rates.,"OBJECTIVE


Tdap vaccine uptake among US pregnant women is low despite current recommendations. This study evaluated if a Tdap vaccine information statement (VIS) affected overall perception, vaccination intention, and components of a health behavior model associated with Tdap vaccination rates.
METHODS


A randomized, prospective study was conducted among pregnant women receiving care at two women's clinics in May-August 2014. Verbally consented participants were randomized to receive either the standard CDC Tdap VIS (sVIS) or a modified version (mVIS) before completing the first multi-part survey (T1). After T1, participants read their assigned VIS then completed the second part (T2). A 2015 chart review identified vaccinated participants. A health behavior model was hypothesized using the Reasoned Action Approach and Health Belief Model. Logistic regression, path analysis, and chi-square tests were used in the analysis.
RESULTS


279 surveys were analyzed. Average age of the participants was 26.4 years (SD=5.7) with average gestational age of 25.9 weeks (SD=9.2). 13% self-reported receiving Tdap vaccine prior to the survey. Overall perception scores significantly increased (3.1-3.4, p<0.001) after VIS review. A chart review showed that 131 (47%) received the vaccine post study. There was no significant difference in vaccination rates between the sVIS and mVIS groups (45% vs. 49%). Perceived benefits (B=0.315) and self-efficacy (B=0.197) were positively associated with the overall perception (T1), while perceived barriers (B=-0.191) were negatively associated with the overall perception (T1). Social norms (B=0.230), self-efficacy (B=0.213), and perceived benefits (B=0.117) were positively associated with vaccination intention (T1). The vaccination intention (T2) was positively associated with participants' decision to receive Tdap vaccine (B=0.223).
CONCLUSION


A VIS improved overall perception of the Tdap vaccine. Vaccination intention was a predictor of Tdap vaccination. It is crucial to provide information about immunization benefits to promote maternal Tdap vaccination.",2016,"Overall perception scores significantly increased (3.1-3.4, p<0.001) after VIS review.","['US pregnant women', 'Average age of the participants was 26.4 years (SD=5.7) with average gestational age of 25.9 weeks (SD=9.2', ""pregnant women receiving care at two women's clinics in May-August 2014""]","['standard CDC Tdap VIS (sVIS) or a modified version (mVIS', 'Tdap vaccine', 'Tdap vaccine information statement (VIS']","['overall perception', 'Overall perception scores', 'vaccination rates', 'self-efficacy']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0007670', 'cui_str': 'CDC'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",279.0,0.0445838,"Overall perception scores significantly increased (3.1-3.4, p<0.001) after VIS review.","[{'ForeName': 'Nalin', 'Initials': 'N', 'LastName': 'Payakachat', 'Affiliation': 'Department of Pharmacy Practice, University of Arkansas for Medical Sciences, Little Rock, AR 72205, USA. Electronic address: npayakachat@uams.edu.'}, {'ForeName': 'Kristie B', 'Initials': 'KB', 'LastName': 'Hadden', 'Affiliation': 'Center for Health Literacy, University of Arkansas for Medical Sciences, Little Rock, AR 72205, USA.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Ragland', 'Affiliation': 'Department of Pharmacy Practice, University of Arkansas for Medical Sciences, Little Rock, AR 72205, USA.'}]",Vaccine,['10.1016/j.vaccine.2015.09.062']
891,26418019,Left Ventricular Wall Stress-Mass-Heart Rate Product and Cardiovascular Events in Treated Hypertensive Patients: LIFE Study.,"In the Losartan Intervention for End Point Reduction in Hypertension (LIFE) study, 4.8 years' losartan- versus atenolol-based antihypertensive treatment reduced left ventricular hypertrophy and cardiovascular end points, including cardiovascular death and stroke. However, there was no difference in myocardial infarction (MI), possibly related to greater reduction in myocardial oxygen demand by atenolol-based treatment. Myocardial oxygen demand was assessed indirectly by the left ventricular mass×wall stress×heart rate (triple product) in 905 LIFE participants. The triple product was included as time-varying covariate in Cox models assessing predictors of the LIFE primary composite end point (cardiovascular death, MI, or stroke), its individual components, and all-cause mortality. At baseline, the triple product in both treatment groups was, compared with normal adults, elevated in 70% of patients. During randomized treatment, the triple product was reduced more by atenolol, with prevalences of elevated triple product of 39% versus 51% on losartan (both P≤0.001). In Cox regression analyses adjusting for age, smoking, diabetes mellitus, and prior stroke, MI, and heart failure, 1 SD lower triple product was associated with 23% (95% confidence interval 13%-32%) fewer composite end points, 31% (18%-41%) less cardiovascular mortality, 30% (15%-41%) lower MI, and 22% (11%-33%) lower all-cause mortality (all P≤0.001), without association with stroke (P=0.34). Although losartan-based therapy reduced ventricular mass more, greater heart rate reduction with atenolol resulted in larger reduction of the triple product. Lower triple product during antihypertensive treatment was strongly, independently associated with lower rates of the LIFE primary composite end point, cardiovascular death, and MI, but not stroke.",2015,"At baseline, the triple product in both treatment groups was, compared with normal adults, elevated in 70% of patients.","['Treated Hypertensive Patients', '905 LIFE participants']","['atenolol', 'losartan- versus atenolol-based antihypertensive', 'losartan']","['myocardial oxygen demand', 'LIFE primary composite end point (cardiovascular death, MI, or stroke), its individual components, and all-cause mortality', 'left ventricular hypertrophy and cardiovascular end points, including cardiovascular death and stroke', 'cause mortality', 'myocardial infarction (MI', 'Left Ventricular Wall Stress-Mass-Heart Rate Product and Cardiovascular Events', 'heart rate reduction', 'cardiovascular mortality', 'Myocardial oxygen demand', 'lower rates of the LIFE primary composite end point, cardiovascular death, and MI, but not stroke']","[{'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0376558', 'cui_str': 'Life'}]","[{'cui': 'C0004147', 'cui_str': 'Atenolol'}, {'cui': 'C0126174', 'cui_str': 'Losartan'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0003364', 'cui_str': 'Anti-Hypertensive Drugs'}]","[{'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0340279', 'cui_str': 'Ventricular hypertrophy (disorder)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0205380', 'cui_str': 'Walled (qualifier value)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]",905.0,0.0458497,"At baseline, the triple product in both treatment groups was, compared with normal adults, elevated in 70% of patients.","[{'ForeName': 'Richard B', 'Initials': 'RB', 'LastName': 'Devereux', 'Affiliation': 'From the Department of Medicine, Weill Medical College of Cornell University, New York, NY (R.B.D., C.N.B., M.J.R., V.P.); Research Unit, Department of Medicine Skellefteå, Umeå University, Skellefteå, Sweden (K.B.); Department of Clinical Science, University of Bergen, Bergen, Norway (E.G.); Department of Cardiology, Helsinki University Central Hospital, Helsinki, Finland (M.S.N.); Division of Cardiology, A.O.S.G. Moscati, Avellino, Italy (V.P.); Department of Medicine, Glostrup University Hospital, Glostrup, Denmark (K.W.); Section on Biostatistics, Merck Research Laboratories, North Wales, PA (D.A.H.); and Department of Medicine, Sahlgrenska University Hospital, Östra, Sweden (B.D.). rbdevere@med.cornell.edu.'}, {'ForeName': 'Casper N', 'Initials': 'CN', 'LastName': 'Bang', 'Affiliation': 'From the Department of Medicine, Weill Medical College of Cornell University, New York, NY (R.B.D., C.N.B., M.J.R., V.P.); Research Unit, Department of Medicine Skellefteå, Umeå University, Skellefteå, Sweden (K.B.); Department of Clinical Science, University of Bergen, Bergen, Norway (E.G.); Department of Cardiology, Helsinki University Central Hospital, Helsinki, Finland (M.S.N.); Division of Cardiology, A.O.S.G. Moscati, Avellino, Italy (V.P.); Department of Medicine, Glostrup University Hospital, Glostrup, Denmark (K.W.); Section on Biostatistics, Merck Research Laboratories, North Wales, PA (D.A.H.); and Department of Medicine, Sahlgrenska University Hospital, Östra, Sweden (B.D.).'}, {'ForeName': 'Mary J', 'Initials': 'MJ', 'LastName': 'Roman', 'Affiliation': 'From the Department of Medicine, Weill Medical College of Cornell University, New York, NY (R.B.D., C.N.B., M.J.R., V.P.); Research Unit, Department of Medicine Skellefteå, Umeå University, Skellefteå, Sweden (K.B.); Department of Clinical Science, University of Bergen, Bergen, Norway (E.G.); Department of Cardiology, Helsinki University Central Hospital, Helsinki, Finland (M.S.N.); Division of Cardiology, A.O.S.G. Moscati, Avellino, Italy (V.P.); Department of Medicine, Glostrup University Hospital, Glostrup, Denmark (K.W.); Section on Biostatistics, Merck Research Laboratories, North Wales, PA (D.A.H.); and Department of Medicine, Sahlgrenska University Hospital, Östra, Sweden (B.D.).'}, {'ForeName': 'Vittorio', 'Initials': 'V', 'LastName': 'Palmieri', 'Affiliation': 'From the Department of Medicine, Weill Medical College of Cornell University, New York, NY (R.B.D., C.N.B., M.J.R., V.P.); Research Unit, Department of Medicine Skellefteå, Umeå University, Skellefteå, Sweden (K.B.); Department of Clinical Science, University of Bergen, Bergen, Norway (E.G.); Department of Cardiology, Helsinki University Central Hospital, Helsinki, Finland (M.S.N.); Division of Cardiology, A.O.S.G. Moscati, Avellino, Italy (V.P.); Department of Medicine, Glostrup University Hospital, Glostrup, Denmark (K.W.); Section on Biostatistics, Merck Research Laboratories, North Wales, PA (D.A.H.); and Department of Medicine, Sahlgrenska University Hospital, Östra, Sweden (B.D.).'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Boman', 'Affiliation': 'From the Department of Medicine, Weill Medical College of Cornell University, New York, NY (R.B.D., C.N.B., M.J.R., V.P.); Research Unit, Department of Medicine Skellefteå, Umeå University, Skellefteå, Sweden (K.B.); Department of Clinical Science, University of Bergen, Bergen, Norway (E.G.); Department of Cardiology, Helsinki University Central Hospital, Helsinki, Finland (M.S.N.); Division of Cardiology, A.O.S.G. Moscati, Avellino, Italy (V.P.); Department of Medicine, Glostrup University Hospital, Glostrup, Denmark (K.W.); Section on Biostatistics, Merck Research Laboratories, North Wales, PA (D.A.H.); and Department of Medicine, Sahlgrenska University Hospital, Östra, Sweden (B.D.).'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Gerdts', 'Affiliation': 'From the Department of Medicine, Weill Medical College of Cornell University, New York, NY (R.B.D., C.N.B., M.J.R., V.P.); Research Unit, Department of Medicine Skellefteå, Umeå University, Skellefteå, Sweden (K.B.); Department of Clinical Science, University of Bergen, Bergen, Norway (E.G.); Department of Cardiology, Helsinki University Central Hospital, Helsinki, Finland (M.S.N.); Division of Cardiology, A.O.S.G. Moscati, Avellino, Italy (V.P.); Department of Medicine, Glostrup University Hospital, Glostrup, Denmark (K.W.); Section on Biostatistics, Merck Research Laboratories, North Wales, PA (D.A.H.); and Department of Medicine, Sahlgrenska University Hospital, Östra, Sweden (B.D.).'}, {'ForeName': 'Markku S', 'Initials': 'MS', 'LastName': 'Nieminen', 'Affiliation': 'From the Department of Medicine, Weill Medical College of Cornell University, New York, NY (R.B.D., C.N.B., M.J.R., V.P.); Research Unit, Department of Medicine Skellefteå, Umeå University, Skellefteå, Sweden (K.B.); Department of Clinical Science, University of Bergen, Bergen, Norway (E.G.); Department of Cardiology, Helsinki University Central Hospital, Helsinki, Finland (M.S.N.); Division of Cardiology, A.O.S.G. Moscati, Avellino, Italy (V.P.); Department of Medicine, Glostrup University Hospital, Glostrup, Denmark (K.W.); Section on Biostatistics, Merck Research Laboratories, North Wales, PA (D.A.H.); and Department of Medicine, Sahlgrenska University Hospital, Östra, Sweden (B.D.).'}, {'ForeName': 'Vasilios', 'Initials': 'V', 'LastName': 'Papademetriou', 'Affiliation': 'From the Department of Medicine, Weill Medical College of Cornell University, New York, NY (R.B.D., C.N.B., M.J.R., V.P.); Research Unit, Department of Medicine Skellefteå, Umeå University, Skellefteå, Sweden (K.B.); Department of Clinical Science, University of Bergen, Bergen, Norway (E.G.); Department of Cardiology, Helsinki University Central Hospital, Helsinki, Finland (M.S.N.); Division of Cardiology, A.O.S.G. Moscati, Avellino, Italy (V.P.); Department of Medicine, Glostrup University Hospital, Glostrup, Denmark (K.W.); Section on Biostatistics, Merck Research Laboratories, North Wales, PA (D.A.H.); and Department of Medicine, Sahlgrenska University Hospital, Östra, Sweden (B.D.).'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Wachtell', 'Affiliation': 'From the Department of Medicine, Weill Medical College of Cornell University, New York, NY (R.B.D., C.N.B., M.J.R., V.P.); Research Unit, Department of Medicine Skellefteå, Umeå University, Skellefteå, Sweden (K.B.); Department of Clinical Science, University of Bergen, Bergen, Norway (E.G.); Department of Cardiology, Helsinki University Central Hospital, Helsinki, Finland (M.S.N.); Division of Cardiology, A.O.S.G. Moscati, Avellino, Italy (V.P.); Department of Medicine, Glostrup University Hospital, Glostrup, Denmark (K.W.); Section on Biostatistics, Merck Research Laboratories, North Wales, PA (D.A.H.); and Department of Medicine, Sahlgrenska University Hospital, Östra, Sweden (B.D.).'}, {'ForeName': 'Darcy A', 'Initials': 'DA', 'LastName': 'Hille', 'Affiliation': 'From the Department of Medicine, Weill Medical College of Cornell University, New York, NY (R.B.D., C.N.B., M.J.R., V.P.); Research Unit, Department of Medicine Skellefteå, Umeå University, Skellefteå, Sweden (K.B.); Department of Clinical Science, University of Bergen, Bergen, Norway (E.G.); Department of Cardiology, Helsinki University Central Hospital, Helsinki, Finland (M.S.N.); Division of Cardiology, A.O.S.G. Moscati, Avellino, Italy (V.P.); Department of Medicine, Glostrup University Hospital, Glostrup, Denmark (K.W.); Section on Biostatistics, Merck Research Laboratories, North Wales, PA (D.A.H.); and Department of Medicine, Sahlgrenska University Hospital, Östra, Sweden (B.D.).'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Dahlöf', 'Affiliation': 'From the Department of Medicine, Weill Medical College of Cornell University, New York, NY (R.B.D., C.N.B., M.J.R., V.P.); Research Unit, Department of Medicine Skellefteå, Umeå University, Skellefteå, Sweden (K.B.); Department of Clinical Science, University of Bergen, Bergen, Norway (E.G.); Department of Cardiology, Helsinki University Central Hospital, Helsinki, Finland (M.S.N.); Division of Cardiology, A.O.S.G. Moscati, Avellino, Italy (V.P.); Department of Medicine, Glostrup University Hospital, Glostrup, Denmark (K.W.); Section on Biostatistics, Merck Research Laboratories, North Wales, PA (D.A.H.); and Department of Medicine, Sahlgrenska University Hospital, Östra, Sweden (B.D.).'}]","Hypertension (Dallas, Tex. : 1979)",['10.1161/HYPERTENSIONAHA.114.05582']
892,31034999,Impact of omalizumab on patient-reported outcomes in chronic idiopathic urticaria: Results from a randomized study (XTEND-CIU).,,2019,,['chronic idiopathic urticaria'],['omalizumab'],[],"[{'cui': 'C0578870', 'cui_str': 'Chronic idiopathic urticaria (disorder)'}]","[{'cui': 'C0966225', 'cui_str': 'omalizumab'}]",[],,0.0127888,,"[{'ForeName': 'Thomas B', 'Initials': 'TB', 'LastName': 'Casale', 'Affiliation': 'University of South Florida, Tampa, Fla.'}, {'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Murphy', 'Affiliation': 'Charleston ENT and Allergy, Charleston, SC.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Holden', 'Affiliation': 'Genentech, Inc., South San Francisco, Calif.'}, {'ForeName': 'Yamina', 'Initials': 'Y', 'LastName': 'Rajput', 'Affiliation': 'Genentech, Inc., South San Francisco, Calif. Electronic address: rajput.yamina@gene.com.'}, {'ForeName': 'Bongin', 'Initials': 'B', 'LastName': 'Yoo', 'Affiliation': 'Genentech, Inc., South San Francisco, Calif.'}, {'ForeName': 'Jonathan A', 'Initials': 'JA', 'LastName': 'Bernstein', 'Affiliation': 'Bernstein Clinical Research Center and University of Cincinnati, Cincinnati, Ohio.'}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2019.04.020']
893,32420973,"Lertal®, a multicomponent nutraceutical, could reduce the use of antihistamines in children with allergic rhinoconjunctivitis.","Antihistamines are the cornerstone treatment of allergic rhinitis (AR). To quantify the antihistaminic consume is particularly relevant in clinical practice, since a remarkable use is usually associated with severe symptoms. The aim of the study was to measure the use of antihistamines in two groups of children suffering from AR. The first group took a course of a nutraceutical (Lertal®) before the observation (active group, AG); a second one was considered as control (control group, CG). Both groups took antihistamines on demand. The children were visited at baseline and after 1 year. The number of days of antihistaminic use was the primary outcome. Children in AG had a significant reduced number of antihistamines use in comparison with CG (p=0.008). In conclusion, the current study showed that a course with a multicomponent nutraceutical could reduce the use of symptomatic antihistamines in children with allergic rhinoconjuncti- vitis.",2020,Children in AG had a significant reduced number of antihistamines use in comparison with CG (p=0.008).,"['children with allergic rhinoconjunctivitis', 'children suffering from AR', 'children with allergic rhinoconjuncti- vitis']","['nutraceutical (Lertal®) before the observation (active group, AG); a second one was considered as control (control group, CG', 'antihistamines', 'Antihistamines']",['number of antihistamines'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0861154', 'cui_str': 'Allergic rhinoconjunctivitis'}, {'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}, {'cui': 'C0949819', 'cui_str': 'Vitis'}]","[{'cui': 'C1518478', 'cui_str': 'Nutriceuticals'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0019590', 'cui_str': 'Histamine receptor antagonist'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0019590', 'cui_str': 'Histamine receptor antagonist'}]",,0.0282658,Children in AG had a significant reduced number of antihistamines use in comparison with CG (p=0.008).,"[{'ForeName': 'Maria Angela', 'Initials': 'MA', 'LastName': 'Tosca', 'Affiliation': 'Allergy Center, Istituto Giannina Gaslini, Genoa, Italy. gio.cip@libero.it.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Olcese', 'Affiliation': 'Allergy Center, Istituto Giannina Gaslini, Genoa, Italy. gio.cip@libero.it.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Marinelli', 'Affiliation': 'Allergy Center, Istituto Giannina Gaslini, Genoa, Italy. gio.cip@libero.it.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Papale', 'Affiliation': 'Department of Clinical and Experimental Medicine, University of Catania, Catania, Italy University . gio.cip@libero.it.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Zicari', 'Affiliation': 'Pediatrics Department, Umberto I Hospital, Roma, Sapienza University , Roma, Italy. gio.cip@libero.it.'}, {'ForeName': 'Gianluigi', 'Initials': 'G', 'LastName': 'Marseglia', 'Affiliation': 'Department of Pediatrics, Fondazione IRCCS Policlinico San Matteo, University of Pavia, Pavia, Italy. gio.cip@libero.it.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Ciprandi', 'Affiliation': 'Allergy Clinic, Villa Montallegro, Genoa, Italy. gio.cip@libero.it.'}]",Acta bio-medica : Atenei Parmensis,['10.23750/abm.v91i2.9719']
894,31793630,Combination Therapy of Adalimumab With an Immunomodulator Is Not More Effective Than Adalimumab Monotherapy in Children With Crohn's Disease: A Post Hoc Analysis of the PAILOT Randomized Controlled Trial.,"BACKGROUND


The PAILOT trial was a randomized controlled trial aimed to evaluate proactive vs reactive therapeutic drug monitoring in children with Crohn's disease (CD) treated with adalimumab. Our aim in this post hoc analysis of the PAILOT trial was to assess the efficacy and safety of adalimumab combination treatment in comparison with monotherapy at week 72 after adalimumab induction.
METHODS


Participants were children 6-17 years old, biologic naïve, with moderate to severe CD, who responded to adalimumab induction at week 4. Patients receiving immunomodulators at baseline maintained a stable dose until week 24; patients could then discontinue immunomodulators. At each visit, patients were assessed for disease index, serum biomarkers, fecal calprotectin, adalimumab trough concentration, and anti-adalimumab antibodies.
RESULTS


Out of the 78 patients (29% female; mean age, 14.3 ± 2.6 years), 34 patients (44%) received combination therapy. During the study period, there was no significant difference in the rates of sustained corticosteroid-free clinical remission (25/34, 73%, vs 28/44, 63%; P = 0.35) or sustained composite outcome of clinical remission, C-reactive protein ≤0.5 mg/dL, and calprotectin ≤150 µg/g (10/34, 29%, vs 14/44, 32%; P = 0.77) between the combination group and the monotherapy group, respectively. Clinical and biological outcomes did not differ between the proactive and reactive subgroups within the combination and monotherapy groups. Adalimumab trough concentrations and immunogenicity were not significantly different between groups. The rate of serious adverse events was not significantly different between groups but was numerically higher in the monotherapy group.
CONCLUSIONS


Combination therapy of adalimumab and an immunomodulator was not more effective than adalimumab monotherapy in children with CD (ClinicalTrials.gov No. NCT02256462).",2020,"The rate of serious adverse events was not significantly different between groups but was numerically higher in the monotherapy group.
","['Participants were children 6-17 years old, biologic naïve, with moderate to severe CD, who responded to adalimumab induction at week 4', 'Children', ""With Crohn's Disease"", '78 patients (29% female; mean age, 14.3 ± 2.6 years), 34 patients (44%) received', ""children with Crohn's disease (CD) treated with""]","['Adalimumab Monotherapy', 'Adalimumab', 'combination therapy', 'adalimumab']","['rates of sustained corticosteroid-free clinical remission', 'rate of serious adverse events', 'efficacy and safety', 'disease index, serum biomarkers, fecal calprotectin, adalimumab trough concentration, and anti-adalimumab antibodies', 'Adalimumab trough concentrations and immunogenicity']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C4553887', 'cui_str': 'Biologic Drugs'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0156147', 'cui_str': 'Colitis, Granulomatous'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517633', 'cui_str': 'Two point six'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}]","[{'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1964053', 'cui_str': 'Faecal calprotectin'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0444506', 'cui_str': 'Trough (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}]",,0.244511,"The rate of serious adverse events was not significantly different between groups but was numerically higher in the monotherapy group.
","[{'ForeName': 'Manar', 'Initials': 'M', 'LastName': 'Matar', 'Affiliation': ""The Institute of Gastroenterology, Nutrition and Liver Diseases, Schneider Children's Hospital, Petach-Tikva, Israel.""}, {'ForeName': 'Raanan', 'Initials': 'R', 'LastName': 'Shamir', 'Affiliation': ""The Institute of Gastroenterology, Nutrition and Liver Diseases, Schneider Children's Hospital, Petach-Tikva, Israel.""}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Turner', 'Affiliation': 'The Juliet Keidan Institute of Pediatric Gastroenterology, Nutrition, Shaare Zedek Medical Center, The Hebrew University, Jerusalem, Israel.'}, {'ForeName': 'Efrat', 'Initials': 'E', 'LastName': 'Broide', 'Affiliation': 'The Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Batia', 'Initials': 'B', 'LastName': 'Weiss', 'Affiliation': 'The Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Oren', 'Initials': 'O', 'LastName': 'Ledder', 'Affiliation': 'The Juliet Keidan Institute of Pediatric Gastroenterology, Nutrition, Shaare Zedek Medical Center, The Hebrew University, Jerusalem, Israel.'}, {'ForeName': 'Anat', 'Initials': 'A', 'LastName': 'Guz-Mark', 'Affiliation': ""The Institute of Gastroenterology, Nutrition and Liver Diseases, Schneider Children's Hospital, Petach-Tikva, Israel.""}, {'ForeName': 'Firas', 'Initials': 'F', 'LastName': 'Rinawi', 'Affiliation': ""The Institute of Gastroenterology, Nutrition and Liver Diseases, Schneider Children's Hospital, Petach-Tikva, Israel.""}, {'ForeName': 'Shlomi', 'Initials': 'S', 'LastName': 'Cohen', 'Affiliation': 'The Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Chani', 'Initials': 'C', 'LastName': 'Topf-Olivestone', 'Affiliation': 'Pediatric Gastroenterology Unit, Kaplan Medical Center, Rehovot, Israel.'}, {'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Shaoul', 'Affiliation': 'Pediatric Gastroenterology Unit, Rambam Medical Center, Haifa, Israel.'}, {'ForeName': 'Baruch', 'Initials': 'B', 'LastName': 'Yerushalmi', 'Affiliation': 'Pediatric Gastroenterology Unit, Saban Pediatric Medical Center, Soroka University Hospital and Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Shomron', 'Initials': 'S', 'LastName': 'Ben-Horin', 'Affiliation': 'The Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Assa', 'Affiliation': ""The Institute of Gastroenterology, Nutrition and Liver Diseases, Schneider Children's Hospital, Petach-Tikva, Israel.""}]",Inflammatory bowel diseases,['10.1093/ibd/izz294']
895,31554075,"Bacillus coagulans GBI-30, 6068 decreases upper respiratory and gastrointestinal tract symptoms in healthy Mexican scholar-aged children by modulating immune-related proteins.","This randomized, double-blind, parallel and placebo-controlled study aimed to evaluate the effect of Bacillus coagulans GBI-30, 6086® probiotic (GanedenBC 30 ®) against upper respiratory tract infections (URTI) and gastrointestinal tract infections (GITI) in eighty healthy school-aged children (6-8 years old). The participants received daily a sachet containing either GanedenBC 30  (1 × 10 9  colony-forming units) or placebo (maltodextrin) for three months. GanedenBC 30  significantly decreased the incidence of URTI symptoms including nasal congestion, bloody nasal mucus, itchy nose, and hoarseness. The duration of the URTI-associated symptoms of hoarseness, headache, red eyes, and fatigue was also decreased. GanedenBC 30  supplementation also significantly reduced the incidence rate of flatulence. These beneficial effects were associated with the modulation of serum TNFα, CD163, G-CSF, ICAM-1, IL-6, IL-8, MCP-2, RAGE, uPAR, and PF4. Therefore, probiotic B. coagulans GBI-30, 6086 modulated immune-related proteins in healthy children, decreasing several URTI and GITI symptoms, thus, this functional ingredient may contribute to a healthier lifestyle.",2019,"These beneficial effects were associated with the modulation of serum TNFα, CD163, G-CSF, ICAM-1, IL-6, IL-8, MCP-2, RAGE, uPAR, and PF4.","['healthy Mexican scholar-aged children', 'eighty healthy school-aged children (6-8\u202fyears old', 'healthy children']","['placebo', 'placebo (maltodextrin', 'Bacillus coagulans GBI-30, 6086® probiotic (GanedenBC 30 ®']","['modulation of serum TNFα, CD163, G-CSF, ICAM-1, IL-6, IL-8, MCP-2, RAGE, uPAR, and PF4', 'duration of the URTI-associated symptoms of hoarseness, headache, red eyes, and fatigue', 'upper respiratory and gastrointestinal tract symptoms', 'incidence rate of flatulence', 'incidence of URTI symptoms including nasal congestion, bloody nasal mucus, itchy nose, and hoarseness']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0686744', 'cui_str': 'Well child (finding)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C0004587', 'cui_str': 'Bacillus'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0079459', 'cui_str': 'G-CSF'}, {'cui': 'C0063695', 'cui_str': 'CD54 Antigens'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0034634', 'cui_str': 'Rage'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0041912', 'cui_str': 'Upper Respiratory Infections'}, {'cui': 'C0521989', 'cui_str': 'Associated symptom (finding)'}, {'cui': 'C0019825', 'cui_str': 'Voice Hoarseness'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0235267', 'cui_str': 'Red eye (disorder)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal Tract'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0027424', 'cui_str': 'Nasal congestion (finding)'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic (qualifier value)'}, {'cui': 'C0225392', 'cui_str': 'Nasal mucus (substance)'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C0028429', 'cui_str': 'Nose'}]",30.0,0.186452,"These beneficial effects were associated with the modulation of serum TNFα, CD163, G-CSF, ICAM-1, IL-6, IL-8, MCP-2, RAGE, uPAR, and PF4.","[{'ForeName': 'Miriam A', 'Initials': 'MA', 'LastName': 'Anaya-Loyola', 'Affiliation': 'Facultad de Ciencias Naturales, Universidad Autónoma de Querétaro, Querétaro 76230, Mexico.'}, {'ForeName': 'José A', 'Initials': 'JA', 'LastName': 'Enciso-Moreno', 'Affiliation': 'Unidad de Investigación Biomédica de Zacatecas, IMSS, Zacatecas 98000, Mexico.'}, {'ForeName': 'Juan E', 'Initials': 'JE', 'LastName': 'López-Ramos', 'Affiliation': 'Unidad de Investigación Biomédica de Zacatecas, IMSS, Zacatecas 98000, Mexico.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'García-Marín', 'Affiliation': 'Facultad de Química, Universidad Autónoma de Querétaro, Querétaro 76010, Mexico.'}, {'ForeName': 'María Y', 'Initials': 'MY', 'LastName': 'Orozco Álvarez', 'Affiliation': 'Facultad de Ciencias Naturales, Universidad Autónoma de Querétaro, Querétaro 76230, Mexico.'}, {'ForeName': 'Ana M', 'Initials': 'AM', 'LastName': 'Vega-García', 'Affiliation': 'Facultad de Ciencias Naturales, Universidad Autónoma de Querétaro, Querétaro 76230, Mexico.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Mosqueda', 'Affiliation': 'Facultad de Ciencias Naturales, Universidad Autónoma de Querétaro, Querétaro 76230, Mexico.'}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'García-Gutiérrez', 'Affiliation': 'Facultad de Química, Universidad Autónoma de Querétaro, Querétaro 76010, Mexico.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Keller', 'Affiliation': 'Keller Consulting Group, Beachwood, OH, USA.'}, {'ForeName': 'Iza F', 'Initials': 'IF', 'LastName': 'Pérez-Ramírez', 'Affiliation': 'Facultad de Química, Universidad Autónoma de Querétaro, Querétaro 76010, Mexico. Electronic address: iza.perez@uaq.mx.'}]","Food research international (Ottawa, Ont.)",['10.1016/j.foodres.2019.108567']
896,32419594,Stromal Cell-Derived Factor-1 Plasmid Treatment for Patients With Peripheral Artery Disease (STOP-PAD) Trial: Six-Month Results.,"Purpose:  To present the 6-month results of the  S tromal Cell-Derived Factor-1 Plasmid  T reatment f o r  P atients with  P eripheral  A rtery  D isease (STOP-PAD) trial. The trial was an attempt to alter the course of chronic limb-threatening ischemia (CLTI) with a biological agent vs placebo after successful arterial revascularization at or below the knee.  Materials and Methods:  The multicenter, randomized, double-blinded, placebo-controlled, phase 2B STOP-PAD trial ( ClinicalTrials.gov  identifier NCT02544204) randomized 109 patients (mean age 71 years; 68 men) with Rutherford category 5 or 6 CLTI and evidence of persistent impaired forefoot perfusion following recent successful revascularization to 8- (n=34) or 16-mg (n=36) intramuscular injections of a non-viral DNA plasmid-based treatment vs placebo (n=34). The primary efficacy outcome was the 6-month wound healing score evaluated by an independent wound core laboratory; the primary safety endpoint was major adverse limb events (MALE), a composite of major amputation plus clinically-driven target lesion revascularization at 6 months.  Results:  Only one-third of the patients had complete wound healing at 6 months in the placebo (31%), 8-mg injection (33%), and 16-mg injection (33%) groups. In addition, the observed increase in the toe-brachial index from baseline to 6 months was statistically significant in each group; however, this did not result in lower rates of MALE at 6 months (24% in the placebo, 29% in the 8-mg injection, and 11% in the 16-mg injection groups). During the 6-month period, 6 patients (6%) died, and 24 patients (23%) had an amputation [only 4 (4%) major].  Conclusion:  Combining revascularization and biological therapy failed to improve outcomes in CLTI at 6 months. STOP-PAD has provided insights for future trials to evaluate biological therapy.",2020,"In addition, the observed increase in the toe-brachial index from baseline to 6 months was statistically significant in each group; however, this did not result in lower rates of MALE at 6 months (24% in the placebo, 29% in the 8-mg injection, and 11% in the 16-mg injection groups).","['109 patients (mean age 71 years; 68 men) with Rutherford category 5 or 6 CLTI and evidence of persistent impaired forefoot perfusion following recent successful revascularization to 8- (n=34) or', '16-mg (n=36', 'Patients With Peripheral Artery Disease']","['Stromal Cell-Derived Factor-1 Plasmid Treatment', 'intramuscular injections of a non-viral DNA plasmid-based treatment vs placebo', 'S tromal Cell-Derived Factor-1 Plasmid  T reatment', 'biological agent vs placebo', 'placebo']","['toe-brachial index', '6-month wound healing score evaluated by an independent wound core laboratory; the primary safety endpoint was major adverse limb events (MALE), a composite of major amputation plus clinically-driven target lesion revascularization at 6 months', 'complete wound healing', 'rates of MALE']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C1510667', 'cui_str': 'Forefoot region of foot'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Arterial Diseases'}]","[{'cui': 'C0218504', 'cui_str': 'CXCL12 Chemokine'}, {'cui': 'C0032136', 'cui_str': 'Plasmid'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0021492', 'cui_str': 'Intramuscular injection'}, {'cui': 'C0012939', 'cui_str': 'Viral DNA'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}]","[{'cui': 'C2116889', 'cui_str': 'Toe brachial index'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0086582', 'cui_str': 'Male'}]",109.0,0.510948,"In addition, the observed increase in the toe-brachial index from baseline to 6 months was statistically significant in each group; however, this did not result in lower rates of MALE at 6 months (24% in the placebo, 29% in the 8-mg injection, and 11% in the 16-mg injection groups).","[{'ForeName': 'Tarek A', 'Initials': 'TA', 'LastName': 'Hammad', 'Affiliation': 'Harrington Heart and Vascular Institute, University Hospitals Cleveland Medical Center and Case Western Reserve University School of Medicine, Cleveland, OH, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Rundback', 'Affiliation': 'Interventional Institute, Holy Name Medical Center, Teaneck, NJ, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Bunte', 'Affiliation': ""Saint Luke's Mid America Heart Institute, St Luke's Hospital and University of Missouri-Kansas City School of Medicine, Kansas City, MO, USA.""}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Miller', 'Affiliation': 'BayCare Physician Partners, Clearwater, FL, USA.'}, {'ForeName': 'Parag D', 'Initials': 'PD', 'LastName': 'Patel', 'Affiliation': 'BayCare Physician Partners, Clearwater, FL, USA.'}, {'ForeName': 'Saihari', 'Initials': 'S', 'LastName': 'Sadanandan', 'Affiliation': ""St Joseph's Hospital, Tampa, FL, USA.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Fitzgerald', 'Affiliation': 'Juventas Therapeutics, Cleveland, OH, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Pastore', 'Affiliation': 'Juventas Therapeutics, Cleveland, OH, USA.'}, {'ForeName': 'Vikram', 'Initials': 'V', 'LastName': 'Kashyap', 'Affiliation': 'Harrington Heart and Vascular Institute, University Hospitals Cleveland Medical Center and Case Western Reserve University School of Medicine, Cleveland, OH, USA.'}, {'ForeName': 'Timothy D', 'Initials': 'TD', 'LastName': 'Henry', 'Affiliation': 'The Christ Hospital, Cincinnati, OH, USA.'}, {'ForeName': 'Mehdi H', 'Initials': 'MH', 'LastName': 'Shishehbor', 'Affiliation': 'Harrington Heart and Vascular Institute, University Hospitals Cleveland Medical Center and Case Western Reserve University School of Medicine, Cleveland, OH, USA.'}]",Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists,['10.1177/1526602820919951']
897,32420695,"A randomized, double-blind, vehicle-controlled clinical study of hair regeneration using adipose-derived stem cell constituent extract in androgenetic alopecia.","Accumulating evidence suggests that adipose-derived stem cell constituent extract (ADSC-CE) helps hair regrowth in patients with androgenetic alopecia (AGA). However, the effects of ADSC-CE have not been demonstrated in a randomized, double-blind, vehicle-controlled clinical trial. In this randomized, double-blind, vehicle-controlled clinical trial, 38 patients (29 men) with AGA were assigned to an intervention group (IG), with twice-daily self-application of the ADSC-CE topical solution over the scalp with fingers, or to a control group (CG). Changes in hair count and thickness at 16 weeks from the baseline were evaluated using a phototrichogram. Overall, 34 (89%) patients (mean age, 45.3 years) completed the study. The phototrichogram at week 8 showed more increase in hair count in the IG than in the CG, and intergroup differences in the change of hair count remained significant until week 16 with overall changes of 28.1% vs 7.1%, respectively. Similarly, a significant improvement in hair diameter was observed in the IG (14.2%) after 16 weeks when compared with hair diameter in the CG (6.3%). Our findings suggest that the application of the ADSC-CE topical solution has enormous potential as an alternative therapeutic strategy for hair regrowth in patients with AGA, by increasing both hair density and thickness while maintaining adequate treatment safety.",2020,"The phototrichogram at week 8 showed more increase in hair count in the IG than in the CG, and intergroup differences in the change of hair count remained significant until week 16 with overall changes of 28.1% vs 7.1%, respectively.","['patients with androgenetic alopecia (AGA', 'androgenetic alopecia', '38 patients (29 men) with AGA']","['hair regeneration using adipose-derived stem cell constituent extract', 'adipose-derived stem cell constituent extract (ADSC-CE', 'ADSC-CE', 'intervention group (IG), with twice-daily self-application of the ADSC-CE topical solution over the scalp with fingers, or to a control group (CG']","['hair count and thickness', 'hair count', 'change of hair count', 'hair diameter']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0162311', 'cui_str': 'Alopecia hereditaria'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C0034963', 'cui_str': 'Regeneration'}, {'cui': 'C0038250', 'cui_str': 'Stem cell'}, {'cui': 'C0729650', 'cui_str': 'Constituents'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0991555', 'cui_str': 'Cutaneous solution'}, {'cui': 'C0036270', 'cui_str': 'Scalp structure'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}]",38.0,0.46629,"The phototrichogram at week 8 showed more increase in hair count in the IG than in the CG, and intergroup differences in the change of hair count remained significant until week 16 with overall changes of 28.1% vs 7.1%, respectively.","[{'ForeName': 'Young Jin', 'Initials': 'YJ', 'LastName': 'Tak', 'Affiliation': 'Department of Family Medicine, Pusan National University School of Medicine, Yangsan, South Korea.'}, {'ForeName': 'Sang Yeoup', 'Initials': 'SY', 'LastName': 'Lee', 'Affiliation': 'Family Medicine Clinic and Research Institute of Convergence of Biomedical Science and Technology, Pusan National University Yangsan Hospital, Yangsan, South Korea.'}, {'ForeName': 'A Ra', 'Initials': 'AR', 'LastName': 'Cho', 'Affiliation': 'Department of Family Medicine, Pusan National University Yangsan Hospital, Yangsan, South Korea.'}, {'ForeName': 'Young Sil', 'Initials': 'YS', 'LastName': 'Kim', 'Affiliation': 'T-Stem, Co., Ltd, Changwon-si, South Korea.'}]",Stem cells translational medicine,['10.1002/sctm.19-0410']
898,32417893,Peak expiratory flow in the standing and sitting positions is equivalent in adults: a cross-over study.,"BACKGROUND


It is uncertain whether peak flow measurement is best done in the standing or sitting position.
METHODS


In this cross-over study, study participants were randomized to perform the initial peak expiratory flow (PEF) measurement in either standing or sitting position. The highest of three readings in each position were compared using paired t-test. A mean difference of <±25 l/min was set as the equivalence limits. Test of equivalence of standing and sitting PEF measurements was done using MedCalc Software. Test of agreement of standing and sitting PEF was assessed by Lin's concordance correlation coefficient and Bland-Altman limits of agreement.
RESULTS


Of the 100 study participants, 50% of them had asthma. There was a statistically significant difference between the standing and sitting PEF in adults suffering from asthma [mean difference 11 l/min, 95% confidence interval (CI) = 4 to 19], but not in the healthy individuals (mean difference 3 l/min, 95% CI = -6 to 12). The observed differences in PEF were small and may not be clinically important. In adults with and without asthma, the standing and sitting PEF were highly correlated and satisfied the test of equivalence.
CONCLUSIONS


The PEF in the standing and sitting positions was equivalent in adults. Therefore, performing PEF in either position is acceptable. However, health care practitioners should be aware of the small reduction in PEF when it is done in the sitting position. It is desirable that the position used is documented and the same position is used wherever possible.",2020,"There was a statistically significant difference between the standing and sitting PEF in adults suffering from asthma [mean difference 11 l/min, 95% confidence interval (CI) = 4 to 19], but not in the healthy individuals (mean difference 3 l/min, 95% CI","['Of the 100 study participants, 50% of them had asthma', 'adults']",[],"['standing and sitting PEF', 'Peak expiratory flow', 'initial peak expiratory flow (PEF) measurement']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]",[],"[{'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",100.0,0.0595707,"There was a statistically significant difference between the standing and sitting PEF in adults suffering from asthma [mean difference 11 l/min, 95% confidence interval (CI) = 4 to 19], but not in the healthy individuals (mean difference 3 l/min, 95% CI","[{'ForeName': 'Cheong Lieng', 'Initials': 'CL', 'LastName': 'Teng', 'Affiliation': 'Department of Family Medicine, International Medical University, Jalan Rasah, Seremban, Malaysia.'}, {'ForeName': 'Kun Mun', 'Initials': 'KM', 'LastName': 'Chia', 'Affiliation': 'Klinik Kesihatan Sentul, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Jasmine', 'Initials': 'J', 'LastName': ""D'Cruz"", 'Affiliation': 'Poliklinik Gomez, Ampang, Malaysia.'}, {'ForeName': 'Colin Adrian', 'Initials': 'CA', 'LastName': 'Gomez', 'Affiliation': 'Poliklinik Gomez, Puchong Jaya, Malaysia.'}, {'ForeName': 'Nesalatchumy', 'Initials': 'N', 'LastName': 'Muthusamy', 'Affiliation': 'Klinik Kesihatan Tanglin, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Nur Syahida', 'Initials': 'NS', 'LastName': 'Saadon', 'Affiliation': 'Klinik Kesihatan Gombak Setia, Gombak, Malaysia.'}, {'ForeName': 'Noraini Mat', 'Initials': 'NM', 'LastName': 'Jali', 'Affiliation': 'Klinik Kesihatan Sungai Besar, Sungai Besar, Malaysia.'}, {'ForeName': 'Li Cher', 'Initials': 'LC', 'LastName': 'Loh', 'Affiliation': 'School of Postgraduate Studies, International Medical University, Kuala Lumpur, Malaysia.'}]",Family practice,['10.1093/fampra/cmaa048']
899,31520242,Pilot Study of Subject Education and Oximetry as They Affect Comfort During Slow-Paced Breathing.,"This study examined the effects of subject education and oximetry on discomfort sometimes associated with slow-paced breathing (dyspnea). This study was performed because some people report anxiety about getting sufficient oxygen while breathing slowly. Clinical experience suggested that reassuring subjects unaccustomed to slow-paced breathing that they are receiving enough oxygen may lead to greater comfort. The study had a sample size of 20 sequentially randomized healthy adults constituting two groups of 10 subjects. Both groups underwent 5 min of video-guided paced breathing at a rate of six breaths per minute. One group was able to view oximetry and hear an educational script, and the other received neither the educational script nor the viewable oximetry. Subjects answered a questionnaire about ease and adequacy of respiration as well as comfort. Analysis of the questionnaire showed that the group who received education about oximetry and viewed an oximeter during training felt significantly greater comfort during slow breathing than the conventional paced breathing group (p < 0.01). While further study is warranted, these preliminary findings suggest the potential need for this dyspneic effect to be taken into account in clinical practice as well as in research.",2020,Analysis of the questionnaire showed that the group who received education about oximetry and viewed an oximeter during training felt significantly greater comfort during slow breathing than the conventional paced breathing group (p < 0.01).,['20 sequentially randomized healthy adults constituting two groups of 10 subjects'],"['video-guided paced breathing', 'subject education and oximetry', 'view oximetry and hear an educational script, and the other received neither the educational script nor the viewable oximetry']",['comfort during slow breathing'],"[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C0018767', 'cui_str': 'Audition'}]","[{'cui': 'C0231837', 'cui_str': 'Slow respiration (finding)'}]",20.0,0.0199525,Analysis of the questionnaire showed that the group who received education about oximetry and viewed an oximeter during training felt significantly greater comfort during slow breathing than the conventional paced breathing group (p < 0.01).,"[{'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Kohlenberg', 'Affiliation': 'Saybrook University, 55 W Eureka St, Pasadena, CA, 91103, USA. skohlenberg@saybrook.edu.'}]",Applied psychophysiology and biofeedback,['10.1007/s10484-019-09451-1']
900,32417629,"Melatonin supplementation and the effects on clinical and metabolic status in Parkinson's disease: A randomized, double-blind, placebo-controlled trial.","OBJECTIVE


This study was performed to evaluate the impact of melatonin supplementation on clinical and metabolic profiles in people with Parkinson's disease (PD).
METHODS


This randomized, double-blind, placebo-controlled clinical trial was conducted among 60 patients with PD. Participants were randomly divided into two groups to intake either 10 mg melatonin (two melatonin capsules, 5 mg each) (n = 30) or placebo (n = 30) once a day, 1 h before bedtime for 12 weeks.
RESULTS


Melatonin supplementation significantly reduced the Unified Parkinson's Disease Rating Scale (UPDRS) part I score (β -2.33; 95% CI, -3.57, -1.09; P < 0.001), Pittsburgh Sleep Quality Index (PSQI) (β -1.82; 95% CI, -3.36, -0.27; P = 0.02), Beck Depression Inventory (BDI) (β -3.32; 95% CI, -5.23, -1.41; P = 0.001) and Beck Anxiety Inventory (BAI) (β -2.22; 95% CI, -3.84, -0.60; P = 0.008) compared with the placebo treatment. Compared with the placebo, melatonin supplementation resulted in a significant reduction in serum high sensitivity C-reactive protein (hs-CRP) (β -0.94 mg/L; 95% CI, -1.55, -0.32; P = 0.003) and a significant elevation in plasma total antioxidant capacity (TAC) (β 108.09 mmol/L; 95% CI, 78.21, 137.97; P < 0.001) and total glutathione (GSH) levels (β 77.08 μmol/L; 95% CI, 44.29, 109.86; P < 0.001). Additionally, consuming melatonin significantly decreased serum insulin levels (β -1.79 μIU/mL; 95% CI, -3.12, -0.46; P = 0.009), homeostasis model of assessment-insulin resistance (HOMA-IR) (β -0.47; 95% CI, -0.80, -0.13; P = 0.007), total- (β -13.16 mg/dL; 95% CI, -25.14, -1.17; P = 0.03) and LDL- (β -10.44 mg/dL; 95% CI, -20.55, -0.34; P = 0.04) compared with the placebo.
CONCLUSIONS


Overall, melatonin supplementation for 12 weeks to patients with PD had favorable effects on the UPDRS part I score, PSQI, BDI, BAI, hs-CRP, TAC, GSH, insulin levels, HOMA-IR, total-, LDL-cholesterol, and gene expression of TNF-α, PPAR-γ and LDLR, but did not affect other metabolic profiles.",2020,"Additionally, consuming melatonin significantly decreased serum insulin levels (β -1.79 μIU/mL; 95% CI, -3.12, -0.46; P = 0.009), homeostasis model of assessment-insulin resistance (HOMA-IR) (β -0.47; 95% CI, -0.80, -0.13; P = 0.007), total- (β","[""Parkinson's disease"", ""people with Parkinson's disease (PD"", '60 patients with PD']","['melatonin supplementation', 'Melatonin supplementation', 'placebo, melatonin supplementation', 'melatonin (two melatonin capsules', 'placebo']","['Pittsburgh Sleep Quality Index (PSQI', 'homeostasis model of assessment-insulin resistance (HOMA-IR', 'UPDRS part I score, PSQI, BDI, BAI, hs-CRP, TAC, GSH, insulin levels, HOMA-IR, total-, LDL-cholesterol, and gene expression of TNF-α, PPAR-γ and LDLR', 'serum high sensitivity C-reactive protein (hs-CRP', 'plasma total antioxidant capacity (TAC', 'total glutathione (GSH) levels', 'LDL', 'Beck Anxiety Inventory (BAI) ', 'Beck Depression Inventory (BDI', 'serum insulin levels', ""Unified Parkinson's Disease Rating Scale (UPDRS) part I score (β""]","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}]","[{'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0006448', 'cui_str': 'Burundi'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C3489891', 'cui_str': 'TAC Alternate'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0166418', 'cui_str': 'PPAR'}, {'cui': 'C0034821', 'cui_str': 'LDL receptor'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0202053', 'cui_str': 'Glutathione measurement'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0582613', 'cui_str': 'Beck anxiety inventory'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}]",60.0,0.782673,"Additionally, consuming melatonin significantly decreased serum insulin levels (β -1.79 μIU/mL; 95% CI, -3.12, -0.46; P = 0.009), homeostasis model of assessment-insulin resistance (HOMA-IR) (β -0.47; 95% CI, -0.80, -0.13; P = 0.007), total- (β","[{'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Daneshvar Kakhaki', 'Affiliation': 'Autoimmune Diseases Research Center, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Vahidreza', 'Initials': 'V', 'LastName': 'Ostadmohammadi', 'Affiliation': 'Infectious Diseases Research Center, Kashan University of Medical Sciences, Kashan, Iran; Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Ebrahim', 'Initials': 'E', 'LastName': 'Kouchaki', 'Affiliation': 'Physiology Research Center, Kashan University of Medical Sciences, Kashan, Iran; Department of Neurology, School of Medicine, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Esmat', 'Initials': 'E', 'LastName': 'Aghadavod', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Fereshteh', 'Initials': 'F', 'LastName': 'Bahmani', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Omid Reza', 'Initials': 'OR', 'LastName': 'Tamtaji', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Russel', 'Initials': 'R', 'LastName': 'J Reiter', 'Affiliation': 'Department of Cellular and Structural Biology, University of Texas Health Science, Center, San Antonio, TX, USA.'}, {'ForeName': 'Mohammad Ali', 'Initials': 'MA', 'LastName': 'Mansournia', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Zatollah', 'Initials': 'Z', 'LastName': 'Asemi', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran. Electronic address: asemi_z@Kaums.ac.ir.'}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2020.105878']
901,26035033,Combination Therapies of Diacerein and Febuxostat Inhibit IL-1β Responses and Improve Clinical Symptoms in Patients With Refractory Gout.,"There are several therapeutic strategies available for the treatment of an acute gout attack and the prevention of recurrent gout flares, and they include nonsteroid anti-inflammatory drugs. This prospective study was aimed at evaluating the efficiency and safety of diacerein in combination with febuxostat on urate control, global assessments of disease activity, self-monitored gouty acute flare times, inflammatory markers, and clinical symptoms associated with their life quantity in patients with refractory gout. A total of 64 patients with refractory gout were sequentially recruited and prescribed with oral febuxostat alone or febuxostat plus diacerein daily for 12 weeks. The intensity of joint pain, numbers of acute flare, disease activity and the levels of serum amyloid A, mature IL-1β, IL-18, C-reactive protein, and urate in individual subjects were routine analyzed. In comparison with that treatment with febuxostat alone, treatment with both drugs for 12 weeks had a better therapeutic effect on reducing the values of visual analog scales, acute flares, and healthy assessment questionnaire scores in these gout patients. Furthermore, treatment with both drugs also significantly reduced the mean daily dose of etoricoxib and the levels of serum IL-1β and serum amyloid A. There was no significant difference in the frequency of patients with adverse effect between these 2 groups of patients. In conclusion, combination of diacerein and febuxostat had better therapeutic effect on reducing acute gout flares, inflammation, and clinical symptoms in patients with refractory gout.",2017,"The intensity of joint pain, numbers of acute flare, disease activity and the levels of serum amyloid A, mature IL-1β, IL-18, C-reactive protein, and urate in individual subjects were routine analyzed.","['64 patients with refractory gout', 'patients with refractory gout', 'Patients With Refractory Gout']","['diacerein and febuxostat', 'febuxostat', 'oral febuxostat alone or febuxostat plus diacerein', 'Diacerein and Febuxostat', 'diacerein']","['mean daily dose of etoricoxib and the levels of serum IL-1β and serum amyloid A', 'values of visual analog scales, acute flares, and healthy assessment questionnaire scores', 'urate control, global assessments of disease activity, self-monitored gouty acute flare times, inflammatory markers, and clinical symptoms', 'frequency of patients with adverse effect', 'intensity of joint pain, numbers of acute flare, disease activity and the levels of serum amyloid A, mature IL-1β, IL-18, C-reactive protein, and urate', 'acute gout flares, inflammation, and clinical symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0018099', 'cui_str': 'Gout'}]","[{'cui': 'C0057678', 'cui_str': 'diacerein'}, {'cui': 'C0249529', 'cui_str': 'febuxostat'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0972314', 'cui_str': 'etoricoxib'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0002723', 'cui_str': 'Amyloid Protein SAA'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0935936', 'cui_str': 'Urate'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0003862', 'cui_str': 'Joint Pain'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205286', 'cui_str': 'Mature (qualifier value)'}, {'cui': 'C0383327', 'cui_str': 'Interferon-gamma-Inducing Factor'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C1619733', 'cui_str': 'Gout flare'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",64.0,0.0462516,"The intensity of joint pain, numbers of acute flare, disease activity and the levels of serum amyloid A, mature IL-1β, IL-18, C-reactive protein, and urate in individual subjects were routine analyzed.","[{'ForeName': 'Yi-Kai', 'Initials': 'YK', 'LastName': 'Yu', 'Affiliation': 'Department of Rheumatology, Wuhan Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Yu', 'Affiliation': ''}, {'ForeName': 'Cong', 'Initials': 'C', 'LastName': 'Ye', 'Affiliation': ''}, {'ForeName': 'Gui-Fen', 'Initials': 'GF', 'LastName': 'Shen', 'Affiliation': ''}, {'ForeName': 'Xiao-Mei', 'Initials': 'XM', 'LastName': 'Lei', 'Affiliation': ''}, {'ForeName': 'Sheng-Tao', 'Initials': 'ST', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Shao-Xian', 'Initials': 'SX', 'LastName': 'Hu', 'Affiliation': ''}]",American journal of therapeutics,['10.1097/MJT.0000000000000284']
902,32420511,Study within a trial (SWAT) protocol. Investigating the effect of personalised versus non-personalised study invitations on recruitment: An embedded randomised controlled recruitment trial.,"Introduction


Recruitment into clinical trials is a common challenge experienced by healthcare researchers. Currently, there is little evidence regarding strategies to improve recruitment into clinical trials. However, preliminary research suggests the personalisation of study invitation letters may increase recruitment rates. As such, there is a need to investigate the effectiveness of personalisation strategies on trial recruitment rates. This study within a trial (SWAT) will investigate the effect of personalised versus non-personalised study invitation letters on recruitment rates into the host trial ENGAGE, a feasibility study of an internet-administered, guided, Cognitive-Behavioural Therapy (CBT) based self-help intervention for parents of children previously treated for cancer.
Methods


An embedded randomised controlled trial (RCT) will investigate the effectiveness of a personalised study invitation letter including the potential participant's name and address compared with a standard, non-personalised letter without name or address, on participant recruitment rates into the ENGAGE study. The primary outcome is differences in the proportion of participants recruited, examined using logistic regression. Results will be reported as adjusted odds ratios with 95% confidence intervals.
Discussion


Even moderate effects of the personalisation of study invitation letters on recruitment rates could be of significant value by shortening study length, saving resources, and providing a faster answer to the clinical question posed by the study. This protocol can be used as a template for other researchers who wish to contribute to the evidence base for trial decision-making, by embedding a similar SWAT into their trial.
Trial registration


ISRCTN 57233429; ISRCTN 18404129; SWAT 112, Northern Ireland Hub for Trials Methodology Research SWAT repository (2018 OCT 1 1231).",2020,"Even moderate effects of the personalisation of study invitation letters on recruitment rates could be of significant value by shortening study length, saving resources, and providing a faster answer to the clinical question posed by the study.",['parents of children previously treated for cancer'],"['personalised versus non-personalised study invitation letters', 'internet-administered, guided, Cognitive-Behavioural Therapy (CBT) based self-help intervention', 'personalised versus non-personalised study invitations']",[],"[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.298338,"Even moderate effects of the personalisation of study invitation letters on recruitment rates could be of significant value by shortening study length, saving resources, and providing a faster answer to the clinical question posed by the study.","[{'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Woodford', 'Affiliation': ""Department of Women's and Children's Health, Uppsala University Psychosocial Care Programme (U-CARE), Uppsala University, Sweden.""}, {'ForeName': 'Kajsa', 'Initials': 'K', 'LastName': 'Norbäck', 'Affiliation': ""Department of Women's and Children's Health, Uppsala University Psychosocial Care Programme (U-CARE), Uppsala University, Sweden.""}, {'ForeName': 'Josefin', 'Initials': 'J', 'LastName': 'Hagström', 'Affiliation': ""Department of Women's and Children's Health, Uppsala University Psychosocial Care Programme (U-CARE), Uppsala University, Sweden.""}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Grönqvist', 'Affiliation': ""Department of Women's and Children's Health, Uppsala University Psychosocial Care Programme (U-CARE), Uppsala University, Sweden.""}, {'ForeName': 'Adwoa', 'Initials': 'A', 'LastName': 'Parker', 'Affiliation': 'Department of Health Sciences, Faculty of Sciences, York Trials Unit, University of York, United Kingdom.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Arundel', 'Affiliation': 'Department of Health Sciences, Faculty of Sciences, York Trials Unit, University of York, United Kingdom.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'von Essen', 'Affiliation': ""Department of Women's and Children's Health, Uppsala University Psychosocial Care Programme (U-CARE), Uppsala University, Sweden.""}]",Contemporary clinical trials communications,['10.1016/j.conctc.2020.100572']
903,32424502,Is there an association between perceived social support and cardiovascular health behaviours in people with severe mental illnesses?,"PURPOSE


People with severe mental illnesses (SMI) have an increased risk of cardiovascular disease (CVD). Research in the general population suggests that social support may protect against increased CVD morbidity and mortality; however, this may not apply to those with SMI. We aimed to explore the association between perceived social support and attendance at primary care nurse CVD risk reduction clinic appointments and CVD risk-reducing behaviours in an SMI population with elevated CVD risk factors.
METHODS


We used longitudinal and cross-sectional data from a randomised controlled trial on 326 adults with SMI recruited via 76 general practices in England. Multilevel regression analysis estimated the effect of perceived social support on attendance at CVD risk reduction clinic appointments over 6 months, and adherence to CVD medication, physical activity, diet, smoking and alcohol use at baseline, adjusted by age, sex, ethnicity, deprivation, psychiatric diagnosis and employment.
RESULTS


Perceived social support predicted greater appointment attendance in unadjusted (IRR = 1.005; 1.000-1.010; p = 0.05) but not adjusted analysis (IRR = 1.003; 0.998-1.009; p = 0.25). Perceived social support was associated with greater adherence to medication; for each 1% increase in social support, there was a 4.2% increase in medication adherence (OR = 1.042; 1.015-1.070; p = 0.002). No association was found between greater perceived social support and greater physical activity, lower sedentary behaviour, healthier diet, lower alcohol use or being a non-smoker.
CONCLUSIONS


Social support may be an important facilitator for CVD medication adherence and is potentially important for primary care appointment attendance; however, alternative strategies might be needed to help people with SMI engage in physical activity, healthier diets and to reduce their smoking and alcohol use.",2020,"No association was found between greater perceived social support and greater physical activity, lower sedentary behaviour, healthier diet, lower alcohol use or being a non-smoker.
CONCLUSIONS


Social support may be an important facilitator for CVD medication adherence and is potentially important for primary care appointment attendance; however, alternative strategies might be needed to help people with SMI engage in physical activity, healthier diets and to reduce their smoking and alcohol use.","['SMI population with elevated CVD risk factors', '326 adults with SMI recruited via 76 general practices in England', 'People with severe mental illnesses (SMI', 'people with severe mental illnesses']",[],"['CVD morbidity and mortality', 'appointment attendance', 'adherence to CVD medication, physical activity, diet, smoking and alcohol use at baseline, adjusted by age, sex, ethnicity, deprivation, psychiatric diagnosis and employment', 'social support and greater physical activity, lower sedentary behaviour, healthier diet', 'risk of cardiovascular disease (CVD', 'social support', 'medication adherence']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C5191353', 'cui_str': '326'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",[],"[{'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0376338', 'cui_str': 'Psychiatric Diagnosis'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}]",326.0,0.0483254,"No association was found between greater perceived social support and greater physical activity, lower sedentary behaviour, healthier diet, lower alcohol use or being a non-smoker.
CONCLUSIONS


Social support may be an important facilitator for CVD medication adherence and is potentially important for primary care appointment attendance; however, alternative strategies might be needed to help people with SMI engage in physical activity, healthier diets and to reduce their smoking and alcohol use.","[{'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Burton', 'Affiliation': 'Division of Psychiatry, University College London, Maple House, 6th floor, 149 Tottenham Court Road, London, W1T 7NF, UK. a.burton@ucl.ac.uk.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Walters', 'Affiliation': 'Department of Primary Care and Population Health, University College London, UCL Medical School (Royal Free Campus), Upper Third Floor, Rowland Hill Street, London, NW3 2PF, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Marston', 'Affiliation': 'Department of Primary Care and Population Health, University College London, UCL Medical School (Royal Free Campus), Upper Third Floor, Rowland Hill Street, London, NW3 2PF, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Osborn', 'Affiliation': 'Division of Psychiatry, University College London, Maple House, 6th floor, 149 Tottenham Court Road, London, W1T 7NF, UK.'}]",Social psychiatry and psychiatric epidemiology,['10.1007/s00127-020-01879-9']
904,31812785,Simulation-based learning to enhance students' knowledge and skills in educating older patients.,"Training nursing students in older patient education may be facilitated by the student elderly simulated-patient strategy. The purpose of this study was to determine the effects of simulation-based learning on students' skills in providing education to older patients. A quasi-experimental design with repeated measures was used. Nursing students enrolled in clinical courses in their semesters 7 and 8 of the program were randomly assigned to simulation-based learning (SBL) group (n = 35) or lecture-based learning (LBL) group (n = 35). In SBL, the student simulated-elderly patients equipped with devices for the age-related hearing loss, vision impairment, and neck, finger, and arm joint stiffness was trained to present the educational content to the students. Outcome (knowledge, attitudes, and skills) data were collected at pre-test, post-test, and one-month follow-up, using reliable measures. Data were analyzed with repeated measures analysis of variance. Students in the SBL and LBL groups were comparable at pre-test. All students demonstrated improvement in knowledge and skills in older patient education over time; however, students in the SBL group had larger and more durable improvements in these outcomes than those in the LBL group (all p's < .001). SBL is a promising instructional method, with long term benefits in improving students' skills.",2020,"All students demonstrated improvement in knowledge and skills in older patient education over time; however, students in the SBL group had larger and more durable improvements in these outcomes than those in the LBL group (all p's < .001).","['educating older patients', ""students' skills in providing education to older patients"", 'Training nursing students in older patient education', 'Nursing students enrolled in clinical courses in their semesters 7 and 8 of the program']","['simulation-based learning (SBL) group (n\xa0=\xa035) or lecture-based learning (LBL', 'Simulation-based learning', 'LBL', 'SBL', 'simulation-based learning']","['Outcome (knowledge, attitudes, and skills) data', 'knowledge and skills']","[{'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0038496', 'cui_str': 'Pupil Nurses'}, {'cui': 'C0030688', 'cui_str': 'Education of Patients'}, {'cui': 'C0449259', 'cui_str': 'Clinical course (attribute)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0376683', 'cui_str': 'Lecture'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]",,0.0184439,"All students demonstrated improvement in knowledge and skills in older patient education over time; however, students in the SBL group had larger and more durable improvements in these outcomes than those in the LBL group (all p's < .001).","[{'ForeName': 'Goodarz', 'Initials': 'G', 'LastName': 'Torkshavand', 'Affiliation': 'School of Nursing and Midwifery, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Mahnaz', 'Initials': 'M', 'LastName': 'Khatiban', 'Affiliation': 'Mother & Child Care Research Center, Dept. of Medical Surgical Nursing, School of Nursing and Midwifery, Hamadan University of Medical Sciences, Hamadan, Iran. Electronic address: mahnaz.khatiban@gmail.com.'}, {'ForeName': 'Ali Reza', 'Initials': 'AR', 'LastName': 'Soltanian', 'Affiliation': 'Modeling of Noncommunicable Disease Research Center, Dept. of Biostatistics and Epidemiology, School of Public Health, Hamadan University of Medical Sciences, Hamadan, Iran.'}]",Nurse education in practice,['10.1016/j.nepr.2019.102678']
905,32000572,Effects of a four-week very low-carbohydrate high-fat diet on biomarkers of inflammation: Non-randomised parallel-group study.,"BACKGROUND


It is commonly assumed that increased dietary fat and/or caloric excess induces chronic inflammatory processes, since the association between obesity and chronic adipose tissue with systemic inflammation has been shown previously. As far as we know, the reported health benefits of a VLCHF or ketogenic diet have not adequately involved an evaluation of biomarkers of inflammation.
AIM


This study investigated the effects of a four-week very low-carbohydrate high-fat (VLCHF) diet in healthy young individuals on biomarkers of inflammation.
METHODS


Eighteen moderately trained males (age 23.8 ± 2.1 years) were assigned to two groups. One group switched to a non-standardised VLCHF diet for four weeks, while the second group remained consuming their normal habitual diet (HD). Biomarkers of inflammation (adiponectin, leptin, resistin and interleukin-6) and substrate metabolism (fasting glucose and triacylglyceride concentrations) were analysed from blood at baseline and after four weeks.
RESULTS


There was moderate evidence for substantial changes in leptin serum concentrations in the VLCHF group, with small to large decreases compared to the HD group after four weeks (effect size = 0.78, 95% CI 0.42, 0.93,  p  = 0.008; Bayes Factor 10  = 5.70). No substantial between-group change differences over time were found across any other biomarkers.
CONCLUSIONS


A four-week period of consuming a VLCHF diet in healthy young men was not associated with any considerable changes in markers of inflammation but showed evidence for lowered serum leptin concentrations relative to the HD group.",2020,"Biomarkers of inflammation (adiponectin, leptin, resistin and interleukin-6) and substrate metabolism (fasting glucose and triacylglyceride concentrations) were analysed from blood at baseline and after four weeks.
","['Eighteen moderately trained males (age 23.8 ± 2.1 years', 'healthy young men', 'healthy young individuals on biomarkers of inflammation']","['VLCHF diet', 'four-week very low-carbohydrate high-fat diet', 'non-standardised VLCHF diet for four weeks, while the second group remained consuming their normal habitual diet (HD', 'four-week very low-carbohydrate high-fat (VLCHF) diet']","['Biomarkers of inflammation (adiponectin, leptin, resistin and interleukin-6) and substrate metabolism (fasting glucose and triacylglyceride concentrations', 'leptin serum concentrations', 'biomarkers of inflammation', 'serum leptin concentrations']","[{'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4068876', 'cui_str': '2.1'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]","[{'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0442811', 'cui_str': 'Very low (qualifier value)'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0521974', 'cui_str': 'Diet, High-Fat'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205353', 'cui_str': 'Habitual (qualifier value)'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0963992', 'cui_str': 'Adipocyte Cysteine-Rich Secreted Protein FIZZ3'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]",18.0,0.0179667,"Biomarkers of inflammation (adiponectin, leptin, resistin and interleukin-6) and substrate metabolism (fasting glucose and triacylglyceride concentrations) were analysed from blood at baseline and after four weeks.
","[{'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Cipryan', 'Affiliation': 'Department of Human Movement Studies and Human Motion Diagnostic Centre, Ostrava University, Czech Republic.'}, {'ForeName': 'Phil B', 'Initials': 'PB', 'LastName': 'Maffetone', 'Affiliation': 'Independent researcher, USA.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Plews', 'Affiliation': 'Sport Performance Research Institute New Zealand (SPRINZ), Auckland University of Technology, New Zealand.'}, {'ForeName': 'Paul B', 'Initials': 'PB', 'LastName': 'Laursen', 'Affiliation': 'Sport Performance Research Institute New Zealand (SPRINZ), Auckland University of Technology, New Zealand.'}]",Nutrition and health,['10.1177/0260106020903206']
906,32424821,Evaluation of Very Integrated Program: Health Promotion for Patients With Alcohol and Drug Addiction-A Randomized Trial.,"BACKGROUND


Compared to the general population, patients with alcohol and drug addiction have an increased risk of additional hazardous lifestyles and suffer from more chronic diseases, adding to their already significantly higher morbidity and mortality. The objective of this study was to test the efficacy of the Very Integrated Program (VIP) on treatment and health outcomes for patients diagnosed with alcohol and drug addiction.
METHODS


Parallel randomized clinical trial with intervention as add-on to addiction care as usual. A total of 322 patients aged 18 years or older were identified, and the study requirements were fulfilled by 219 patients, 7 of whom participated in a pilot. The intervention was a 6-week intensive, tailored, educational program that included motivational interviewing, a smoking cessation program, dietary and physical activity counseling, and patient education. The main outcome measures were substance-free days, time to relapse, and treatment adherence assessed after 6 weeks and 12 months. Secondary outcomes were lifestyle factors, symptoms of comorbidity, and quality of life. Missing data were imputed conservatively by using data closest to the follow-up date and baseline values in patients with no follow-up.
RESULTS


The 212 patients (intervention, n = 113; control, n = 99) were randomized, and 202 had complete data for primary outcomes. After 6 weeks, there were no significant differences between the groups regarding primary or secondary outcomes. At the 12-month follow-up, the patients in the control group had significantly more total substance-free days (139 days; ranging 0 to 365 vs. 265; 0 to 366, p = 0.021)-specifically among the patients with drug addiction-and higher physical and mental quality of life (45 vs. 58, p = 0.049 and 54 vs. 66, p = 0.037), but not in the per-protocol analysis (60 vs. 46, p = 0.52 and 70 vs. 66, p = 0.74). The sensitivity analyses did not support significant differences between the groups.
CONCLUSION


Overall, adding VIP intervention did not improve outcome of the alcohol or drug addiction care or the lifestyle compared to the addiction care alone. This patient group is still in need of effective programs, and new intervention research is required to develop that.",2020,"At the 12-month follow-up, the patients in the control group had significantly more total substance-free days (139 days; ranging 0-365 vs. 265; 0-366, p=0.021) - specifically among the patients with drug addiction - and higher physical and mental quality of life (45 vs 58, p= 0.049 and 54 vs. 66, p=0.037), but not in the per-protocol analysis (60 vs. 46, p=0.52 and 70 vs. 66, p=0.74).","['212 patients (intervention, n=113; control, n=99', 'patients diagnosed with alcohol and drug addiction', '322 patients aged 18 years or older were identified, and the study requirements were fulfilled by 219 patients, 7 of whom participated in a pilot', 'patients with alcohol and drug addiction ']","['educational program that included motivational interviewing, a smoking cessation program, dietary and physical activity counseling, and patient education', 'Very Integrated Program (VIP', 'Very Integrated Program (VIP): Health promotion']","['substance-free days, time to relapse and treatment adherence', 'total substance-free days', 'alcohol or drug addiction care or the lifestyle', 'physical and mental quality of life', 'lifestyle factors, symptoms of comorbidity, and quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C1510472', 'cui_str': 'Drug dependence'}, {'cui': 'C4517712', 'cui_str': '322'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517648', 'cui_str': '219'}, {'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0030688', 'cui_str': 'Patient education'}, {'cui': 'C0018738', 'cui_str': 'Health promotion'}]","[{'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C4505265', 'cui_str': 'Therapeutic Adherence'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C1510472', 'cui_str': 'Drug dependence'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}]",322.0,0.0700003,"At the 12-month follow-up, the patients in the control group had significantly more total substance-free days (139 days; ranging 0-365 vs. 265; 0-366, p=0.021) - specifically among the patients with drug addiction - and higher physical and mental quality of life (45 vs 58, p= 0.049 and 54 vs. 66, p=0.037), but not in the per-protocol analysis (60 vs. 46, p=0.52 and 70 vs. 66, p=0.74).","[{'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Hovhannisyan', 'Affiliation': 'From the, Department of Health Science, (KH, MR, MW, HT), Clinical Health Promotion Centre, WHO-CC, Region Skåne, Lund University, Lund, Sweden.'}, {'ForeName': 'Mette', 'Initials': 'M', 'LastName': 'Rasmussen', 'Affiliation': 'From the, Department of Health Science, (KH, MR, MW, HT), Clinical Health Promotion Centre, WHO-CC, Region Skåne, Lund University, Lund, Sweden.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Adami', 'Affiliation': 'Sophiahemmet University, (JA), Stockholm, Sweden.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Wikström', 'Affiliation': 'From the, Department of Health Science, (KH, MR, MW, HT), Clinical Health Promotion Centre, WHO-CC, Region Skåne, Lund University, Lund, Sweden.'}, {'ForeName': 'Hanne', 'Initials': 'H', 'LastName': 'Tønnesen', 'Affiliation': 'From the, Department of Health Science, (KH, MR, MW, HT), Clinical Health Promotion Centre, WHO-CC, Region Skåne, Lund University, Lund, Sweden.'}]","Alcoholism, clinical and experimental research",['10.1111/acer.14364']
907,25614429,The effect of rosuvastatin on platelet-leukocyte interactions in the setting of acute coronary syndrome.,,2015,,['acute coronary syndrome'],['rosuvastatin'],['platelet-leukocyte interactions'],"[{'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}]","[{'cui': 'C0965129', 'cui_str': 'rosuvastatin'}]","[{'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0023516', 'cui_str': 'Blood Corpuscles, White'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}]",,0.014131,,"[{'ForeName': 'Travis R', 'Initials': 'TR', 'LastName': 'Sexton', 'Affiliation': ''}, {'ForeName': 'Eric L', 'Initials': 'EL', 'LastName': 'Wallace', 'Affiliation': ''}, {'ForeName': 'Tracy E', 'Initials': 'TE', 'LastName': 'Macaulay', 'Affiliation': ''}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Charnigo', 'Affiliation': ''}, {'ForeName': 'Virgilio', 'Initials': 'V', 'LastName': 'Evangelista', 'Affiliation': ''}, {'ForeName': 'Charles L', 'Initials': 'CL', 'LastName': 'Campbell', 'Affiliation': ''}, {'ForeName': 'Alison L', 'Initials': 'AL', 'LastName': 'Bailey', 'Affiliation': ''}, {'ForeName': 'Susan S', 'Initials': 'SS', 'LastName': 'Smyth', 'Affiliation': ''}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2014.10.047']
908,32065601,Effect of No Prehydration vs Sodium Bicarbonate Prehydration Prior to Contrast-Enhanced Computed Tomography in the Prevention of Postcontrast Acute Kidney Injury in Adults With Chronic Kidney Disease: The Kompas Randomized Clinical Trial.,"Importance


Prevention of postcontrast acute kidney injury in patients with stage 3 chronic kidney disease (CKD) by means of prehydration has been standard care for years. However, evidence for the need for prehydration in this group is limited.
Objective


To assess the renal safety of omitting prophylactic prehydration prior to iodine-based contrast media administration in patients with stage 3 CKD.
Design, Setting, and Participants


The Kompas trial was a multicenter, noninferiority, randomized clinical trial conducted at 6 hospitals in the Netherlands in which 523 patients with stage 3 CKD were randomized in a 1:1 ratio to receive no prehydration or prehydration with 250 mL of 1.4% sodium bicarbonate administered in a 1-hour infusion before undergoing elective contrast-enhanced computed tomography from April 2013 through September 2016. Final follow-up was completed in September 2017. Data were analyzed from January 2018 to June 2019.
Interventions


In total, 262 patients were allocated to the no prehydration group and 261 were allocated to receive prehydration. Analysis on the primary end point was available in 505 patients (96.6%).
Main Outcomes and Measures


The primary end point was the mean relative increase in serum creatinine level 2 to 5 days after contrast administration compared with baseline (noninferiority margin of less than 10% increase in serum creatinine level). Secondary outcomes included the incidence of postcontrast acute kidney injury 2 to 5 days after contrast administration, mean relative increase in creatinine level 7 to 14 days after contrast administration, incidences of acute heart failure and renal failure requiring dialysis, and health care costs.
Results


Of 554 patients randomized, 523 were included in the intention-to-treat analysis. The median (interquartile range) age was 74 (67-79) years; 336 (64.2%) were men and 187 (35.8%) were women. The mean (SD) relative increase in creatinine level 2 to 5 days after contrast administration compared with baseline was 3.0% (10.5) in the no prehydration group vs 3.5% (10.3) in the prehydration group (mean difference, 0.5; 95% CI, -1.3 to 2.3; P < .001 for noninferiority). Postcontrast acute kidney injury occurred in 11 patients (2.1%), including 7 of 262 (2.7%) in the no prehydration group and 4 of 261 (1.5%) in the prehydration group, which resulted in a relative risk of 1.7 (95% CI, 0.5-5.9; P = .36). None of the patients required dialysis or developed acute heart failure. Subgroup analyses showed no evidence of statistical interactions between treatment arms and predefined subgroups. Mean hydration costs were €119 (US $143.94) per patient in the prehydration group compared with €0 (US $0) in the no prehydration group (P < .001). Other health care costs were similar.
Conclusions and Relevance


Among patients with stage 3 CKD undergoing contrast-enhanced computed tomography, withholding prehydration did not compromise patient safety. The findings of this study support the option of not giving prehydration as a safe and cost-efficient measure.
Trial Registration


Netherlands Trial Register Identifier: NTR3764.",2020,Mean hydration costs were €119 (US $143.94) per patient in the prehydration group compared with €0 (US $0) in the no prehydration group (P < .001).,"['6 hospitals in the Netherlands in which 523 patients with stage 3 CKD', '262 patients', 'patients with stage', 'The median (interquartile range) age was 74 (67-79) years; 336 (64.2%) were men and 187 (35.8%) were women', 'patients with stage 3 CKD', 'patients with stage 3 chronic kidney disease (CKD', 'Adults With Chronic Kidney Disease', '554 patients randomized', 'Data were analyzed from January 2018 to June 2019']","['prehydration', 'no prehydration or prehydration with 250 mL of 1.4% sodium bicarbonate', 'omitting prophylactic prehydration prior to iodine-based contrast media administration', 'Contrast-Enhanced Computed Tomography', 'No Prehydration vs Sodium Bicarbonate Prehydration']","['incidence of postcontrast acute kidney injury 2 to 5 days after contrast administration, mean relative increase in creatinine level 7 to 14 days after contrast administration, incidences of acute heart failure and renal failure requiring dialysis, and health care costs', 'Postcontrast acute kidney injury', 'Mean hydration costs', 'serum creatinine level', 'mean (SD) relative increase in creatinine level', 'renal safety', 'safe and cost-efficient measure', 'acute heart failure']","[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4517618', 'cui_str': '187 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C4517503', 'cui_str': '1.4 (qualifier value)'}, {'cui': 'C0074722', 'cui_str': 'Sodium Bicarbonate'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0021968', 'cui_str': 'molecular iodine'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009924', 'cui_str': 'Contrast Agents'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C2609414', 'cui_str': 'Acute Renal Injury'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0428279', 'cui_str': 'Finding of creatinine level (finding)'}, {'cui': 'C0264714', 'cui_str': 'Acute heart failure (disorder)'}, {'cui': 'C0035078', 'cui_str': 'Kidney Failure'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}, {'cui': 'C1321013', 'cui_str': 'Hydration'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0600061', 'cui_str': 'Serum creatinine level - finding'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0442799', 'cui_str': 'Efficient (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",262.0,0.201305,Mean hydration costs were €119 (US $143.94) per patient in the prehydration group compared with €0 (US $0) in the no prehydration group (P < .001).,"[{'ForeName': 'Rohit J', 'Initials': 'RJ', 'LastName': 'Timal', 'Affiliation': 'Department of Cardiology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Kooiman', 'Affiliation': 'Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Yvo W J', 'Initials': 'YWJ', 'LastName': 'Sijpkens', 'Affiliation': 'Department of Internal Medicine, Haaglanden Medisch Centrum Bronovo, The Hague, the Netherlands.'}, {'ForeName': 'Jean-Paul P M', 'Initials': 'JPM', 'LastName': 'de Vries', 'Affiliation': 'Department of Vascular Surgery, St Antonius Hospital, Nieuwegein, the Netherlands.'}, {'ForeName': 'Iris J A M', 'Initials': 'IJAM', 'LastName': 'Verberk-Jonkers', 'Affiliation': 'Department of Internal Medicine, Maasstad Hospital, Rotterdam, the Netherlands.'}, {'ForeName': 'Harald F H', 'Initials': 'HFH', 'LastName': 'Brulez', 'Affiliation': 'Department of Internal Medicine, Onze Lieve Vrouwe Gasthuis, Amsterdam, the Netherlands.'}, {'ForeName': 'Marjolijn', 'Initials': 'M', 'LastName': 'van Buren', 'Affiliation': 'Department of Internal Medicine, Haga Teaching Hospital, The Hague, the Netherlands.'}, {'ForeName': 'Aart J', 'Initials': 'AJ', 'LastName': 'van der Molen', 'Affiliation': 'Department of Radiology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Suzanne C', 'Initials': 'SC', 'LastName': 'Cannegieter', 'Affiliation': 'Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Hein', 'Initials': 'H', 'LastName': 'Putter', 'Affiliation': 'Department of Biomedical Data Sciences, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Wilbert B', 'Initials': 'WB', 'LastName': 'van den Hout', 'Affiliation': 'Department of Biomedical Data Sciences, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'J Wouter', 'Initials': 'JW', 'LastName': 'Jukema', 'Affiliation': 'Department of Cardiology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Ton J', 'Initials': 'TJ', 'LastName': 'Rabelink', 'Affiliation': 'Department of Internal Medicine, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Menno V', 'Initials': 'MV', 'LastName': 'Huisman', 'Affiliation': 'Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands.'}]",JAMA internal medicine,['10.1001/jamainternmed.2019.7428']
909,24349532,Impact of interleukin-18 polymorphisms -607A/C and -137G/C on oral cancer occurrence and clinical progression.,"BACKGROUND


The purpose of this study was to identify gene polymorphisms of interleukin-18 (IL-18) -607A/C and -137G/C specific to patients with oral cancer susceptibility and clinicopathological status.
METHODOLOGY AND PRINCIPAL FINDINGS


A total of 1,126 participants, including 559 healthy people and 567 patients with oral cancer, were recruited for this study. Allelic discrimination of -607A/C (rs1946518) and -137G/C (rs187238) polymorphisms of the IL-18 gene was assessed by a real-time PCR with the TaqMan assay. There was no significant association between IL-18 -607A/C polymorphism and oral cancer risk. However, among alcohol consumers, people with A/A homozygotes of IL-18 -607A/C polymorphism had a 2.38-fold (95% CI=1.17-4.86; p=0.01) increased risk of developing oral cancer compared with those with C/C homozygotes. The participants with G/C heterozygotes of IL-18 -137 polymorphism had a 1.64-fold (95% CI: 1.08-2.48; p=0.02) increased risk of developing oral cancer compared with those with G/G wild type homozygotes. Both sets of statistics were determined after adjusting for confounding factors. Among people who had exposure to oral cancer-related environmental risk factors such as areca, alcohol, and tobacco consumption, the adjusted odd ratios and 95% confidence intervals were increased to a 2.02-fold (95% CI=1.01-4.04; p=0.04), 4.04 (95% CI=1.65-9.87; p=0.002) and a 1.66-fold (95% CI=1.00-2.84; p=0.05) risk of developing oral cancer. However, patients with G/C alleles of IL-18 -137 were correlated with a lower clinical stage (AOR=0.59; 95% CI=0.39-0.89; p=0.01), smaller tumor size (AOR=0.56; 95% CI=0.35-0.87; p=0.01), and non-lymph node metastasis (AOR=0.51; 95% CI=0.32-0.80; p=0.003).
CONCLUSION


IL-18 -137 G/C gene polymorphism may be a factor that increases the susceptibility to oral cancer, as well as a protective factor for oral cancer progression. The interactions of gene to oral cancer-related environmental risk factors have a synergetic effect that can further enhance oral cancer development.",2013,A/A homozygotes of IL-18 -607A/C polymorphism had a 2.38-fold (95% CI=1.17-4.86; p=0.01) increased risk of developing oral cancer compared with those with C/C homozygotes.,"['A total of 1,126 participants, including 559 healthy people and 567 patients with oral cancer', 'patients with oral cancer susceptibility and clinicopathological status']",['interleukin-18 polymorphisms -607A/C and -137G/C'],"['risk of developing oral cancer', 'IL-18 -607A/C polymorphism and oral cancer risk', 'non-lymph node metastasis', 'Allelic discrimination of -607A/C (rs1946518) and -137G/C (rs187238) polymorphisms of the IL-18 gene', 'oral cancer occurrence and clinical progression', 'smaller tumor size']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0153381', 'cui_str': 'Cancer of Mouth'}, {'cui': 'C1264642', 'cui_str': 'Susceptibility (property) (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]","[{'cui': 'C0383327', 'cui_str': 'Interferon-gamma-Inducing Factor'}, {'cui': 'C0032529', 'cui_str': 'Polymorphism (Genetics)'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0153381', 'cui_str': 'Cancer of Mouth'}, {'cui': 'C0383327', 'cui_str': 'Interferon-gamma-Inducing Factor'}, {'cui': 'C0032529', 'cui_str': 'Polymorphism (Genetics)'}, {'cui': 'C0686619', 'cui_str': 'Secondary malignant neoplasm of lymph node'}, {'cui': 'C0012632', 'cui_str': 'Discrimination'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0475277', 'cui_str': 'Small tumor (finding)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}]",1126.0,0.17814,A/A homozygotes of IL-18 -607A/C polymorphism had a 2.38-fold (95% CI=1.17-4.86; p=0.01) increased risk of developing oral cancer compared with those with C/C homozygotes.,"[{'ForeName': 'Hsiu-Ting', 'Initials': 'HT', 'LastName': 'Tsai', 'Affiliation': 'School of Nursing, Chung Shan Medical University, Taichung, Taiwan ; Department of Nursing, Chung Shan Medical University Hospital, Taichung, Taiwan.'}, {'ForeName': 'Chung-Han', 'Initials': 'CH', 'LastName': 'Hsin', 'Affiliation': 'School of Medicine, Chung Shan Medical University, Taichung, Taiwan ; Department of Otolaryngology, Chung Shan Medical University Hospital, Taichung, Taiwan.'}, {'ForeName': 'Yi-Hsien', 'Initials': 'YH', 'LastName': 'Hsieh', 'Affiliation': 'Department of Biochemistry, School of Medicine, Chung Shan Medical University, Taichung, Taiwan.'}, {'ForeName': 'Chih-Hsin', 'Initials': 'CH', 'LastName': 'Tang', 'Affiliation': 'Graduate Institute of Basic Medical Science, China Medical University, Taichung, Taiwan ; Department of Biotechnology, College of Health Science, Asia University, Taichung, Taiwan.'}, {'ForeName': 'Shun-Fa', 'Initials': 'SF', 'LastName': 'Yang', 'Affiliation': 'Institute of Medicine, Chung Shan Medical University, Taichung, Taiwan.'}, {'ForeName': 'Chiao-Wen', 'Initials': 'CW', 'LastName': 'Lin', 'Affiliation': 'Institute of Oral Sciences, Chung Shan Medical University, Taichung, Taiwan ; Department of Dentistry, Chung Shan Medical University Hospital, Taichung, Taiwan.'}, {'ForeName': 'Mu-Kuan', 'Initials': 'MK', 'LastName': 'Chen', 'Affiliation': 'Institute of Medicine, Chung Shan Medical University, Taichung, Taiwan ; Department of Otorhinolaryngology-Head and Neck Surgery, Changhua Christian Hospital, Changhua, Taiwan.'}]",PloS one,['10.1371/journal.pone.0083572']
910,23601186,Oral paricalcitol reduces the prevalence of posttransplant hyperparathyroidism: results of an open label randomized trial.,"Postkidney transplant hyperparathyroidism is a significant problem. Vitamin D receptor agonists are known to suppress parathyroid hormone (PTH) secretion. We examined the effect of oral paricalcitol on posttransplant secondary hyperparathyroidism by conducting an open label randomized trial in which 100 incident kidney transplant recipients were randomized 1:1 to receive oral paricalcitol, 2 μg per day, for the first year posttransplant or no additional therapy. Serial measurements of serum PTH, calcium and bone alkaline phosphatase, 24-h urine calcium and bone density were performed. The primary endpoint was the frequency of hyperparathyroidism 1-year posttransplant. Eighty-seven patients completed the trial. One-year posttransplant, 29% of paricalcitol-treated subjects had hyperparathyroidism compared with 63% of untreated patients (p = 0.0005). Calcium supplementation was discontinued in two control and 15 treatment patients due to mild hypercalcemia or hypercalcuria. Paricalcitol was discontinued in four patients due to hypercalcuria/hypercalcemia and in one for preference. Two subjects required decreasing the dose of paricalcitol to 1 μg daily. Hypercalcemia was asymptomatic and reversible. Incidence of acute rejection, BK nephropathy and renal function at 1 year were similar between groups. Moderate renal allograft fibrosis was reduced in treated patients. Oral paricalcitol is effective in decreasing posttransplant hyperparathyroidism and may have beneficial effects on renal allograft histology.",2013,"Incidence of acute rejection, BK nephropathy and renal function at 1 year were similar between groups.","['100 incident kidney transplant recipients', 'Eighty-seven patients completed the trial']","['Paricalcitol', 'Oral paricalcitol', 'oral paricalcitol', 'paricalcitol', 'Calcium supplementation']","['serum PTH, calcium and bone alkaline phosphatase, 24-h urine calcium and bone density', 'Incidence of acute rejection, BK nephropathy and renal function', 'frequency of hyperparathyroidism 1-year posttransplant', 'parathyroid hormone (PTH) secretion', 'hyperparathyroidism', 'Hypercalcemia', 'posttransplant hyperparathyroidism', 'Moderate renal allograft fibrosis', 'prevalence of posttransplant hyperparathyroidism', 'posttransplant secondary hyperparathyroidism', 'mild hypercalcemia or hypercalcuria']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}, {'cui': 'C4517895', 'cui_str': 'Eighty-seven'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0249582', 'cui_str': 'paricalcitol'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1096745', 'cui_str': 'Calcium supplement therapy (regime/therapy)'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0202159', 'cui_str': 'Parathyroid hormone measurement (procedure)'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C1868883', 'cui_str': 'Bone alkaline phosphatase'}, {'cui': 'C0428303', 'cui_str': 'Calcium measurement, urine (procedure)'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0035015', 'cui_str': 'Rejection'}, {'cui': 'C0022658', 'cui_str': 'Kidney Diseases'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C1840402'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0030520', 'cui_str': 'Parathyroid Hormone'}, {'cui': 'C0036537', 'cui_str': 'Secretions'}, {'cui': 'C0020502', 'cui_str': 'Hyperparathyroidism'}, {'cui': 'C0020437', 'cui_str': 'Hypercalcemia'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0450127', 'cui_str': 'Allogeneic Grafts'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0020503', 'cui_str': 'Hyperparathyroidism, Secondary'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0020438', 'cui_str': 'Hypercalciuria'}]",,0.0341184,"Incidence of acute rejection, BK nephropathy and renal function at 1 year were similar between groups.","[{'ForeName': 'H', 'Initials': 'H', 'LastName': 'Amer', 'Affiliation': 'Division of Nephrology and Hypertension, Department of Medicine, Mayo Clinic, Rochester, MN, USA. amer.hatem@mayo.edu'}, {'ForeName': 'M D', 'Initials': 'MD', 'LastName': 'Griffin', 'Affiliation': ''}, {'ForeName': 'M D', 'Initials': 'MD', 'LastName': 'Stegall', 'Affiliation': ''}, {'ForeName': 'F G', 'Initials': 'FG', 'LastName': 'Cosio', 'Affiliation': ''}, {'ForeName': 'W D', 'Initials': 'WD', 'LastName': 'Park', 'Affiliation': ''}, {'ForeName': 'W K', 'Initials': 'WK', 'LastName': 'Kremers', 'Affiliation': ''}, {'ForeName': 'R L', 'Initials': 'RL', 'LastName': 'Heilman', 'Affiliation': ''}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Mazur', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Hamawi', 'Affiliation': ''}, {'ForeName': 'T S', 'Initials': 'TS', 'LastName': 'Larson', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Kumar', 'Affiliation': ''}]",American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons,['10.1111/ajt.12227']
911,23653013,Testosterone replacement for fatigue in hypogonadal ambulatory males with advanced cancer: a preliminary double-blind placebo-controlled trial.,"BACKGROUND


Uncontrolled studies show fatigue, anorexia, depression, and mortality are associated with low testosterone in men with cancer. Testosterone replacement improves quality of life and diminishes fatigue in patients with non-cancer conditions. The primary objective was to evaluate the effect of testosterone replacement on fatigue in hypogonadal males with advanced cancer, by the Functional Assessment of Chronic Illness Therapy-Fatigue subscale (FACIT-Fatigue) at day 29.
METHODS


This is a randomized, double-blinded placebo-controlled trial. Outpatients with advanced cancer, bioavailable testosterone (BT) <70 ng/dL and fatigue score >3/10 on the Edmonton Symptom Assessment Scale were eligible. Intra-muscular testosterone or sesame seed oil placebo was administered every 14 days to achieve BT levels 70-270 ng/dL.
RESULTS


Sixteen placebo and 13 testosterone-treated subjects were evaluable. No statistically significant difference was found for FACIT-fatigue scores between arms (-2 ± 12 for placebo, 4 ± 8 for testosterone, p = 0.11). Sexual Desire Inventory score (p = 0.054) and performance status (p = 0.02) improved in the testosterone group. Fatigue subscale scores were significantly better (p = 0.03) in those treated with testosterone by day 72.
CONCLUSIONS


Four weeks of intramuscular testosterone replacement in hypogonadal male patients with advanced cancer did not significantly improve quality of life. Larger studies of longer duration are warranted.",2013,"No statistically significant difference was found for FACIT-fatigue scores between arms (-2 ± 12 for placebo, 4 ± 8 for testosterone, p = 0.11).","['and 13 testosterone-treated subjects were evaluable', 'hypogonadal ambulatory males with advanced cancer', 'Outpatients with advanced cancer, bioavailable testosterone (BT) <70 ng/dL and fatigue score >3/10 on the Edmonton Symptom Assessment Scale were eligible', 'men with cancer', 'hypogonadal male patients with advanced cancer', 'patients with non-cancer conditions', 'hypogonadal males with advanced cancer, by the Functional Assessment of Chronic Illness Therapy-Fatigue subscale (FACIT-Fatigue) at day 29']","['testosterone', 'placebo', 'intramuscular testosterone replacement', 'testosterone replacement', 'Testosterone replacement', 'Intra-muscular testosterone or sesame seed oil placebo']","['performance status', 'quality of life', 'quality of life and diminishes fatigue', 'FACIT-fatigue scores', 'Sexual Desire Inventory score', 'Fatigue subscale scores']","[{'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0370051', 'cui_str': 'Bioavailable testosterone (substance)'}, {'cui': 'C0439274', 'cui_str': 'ng/dL'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3494437', 'cui_str': 'Symptom Assessment'}, {'cui': 'C0222045'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0008679', 'cui_str': 'Chronic Illness'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular (qualifier value)'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0442025', 'cui_str': 'Muscular (qualifier value)'}, {'cui': 'C0440299', 'cui_str': 'Sesame seed (substance)'}, {'cui': 'C0028908', 'cui_str': 'Oils'}]","[{'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0034380'}, {'cui': 'C0205216', 'cui_str': 'Decreased (qualifier value)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0424400', 'cui_str': 'Erotic interest (observable entity)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0459443', 'cui_str': 'Subscale score (qualifier value)'}]",,0.727443,"No statistically significant difference was found for FACIT-fatigue scores between arms (-2 ± 12 for placebo, 4 ± 8 for testosterone, p = 0.11).","[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Del Fabbro', 'Affiliation': 'University of Texas M D Anderson Cancer Center, Department of Palliative Care and Rehabilitation Medicine, Houston, TX, USA. edelfabbro@vcu.edu'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Garcia', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Dev', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Hui', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Williams', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Engineer', 'Affiliation': ''}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Palmer', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Schover', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Bruera', 'Affiliation': ''}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-013-1832-5']
912,32426949,Protein quality in ready-to-use supplementary foods for moderate wasting.,"There are no guidelines for the optimal protein quality of ready-to-supplementary food (RUSF) for moderate acute malnutrition (MAM). This randomized, controlled, double-blinded, clinical effectiveness trial evaluated two RUSFs in the treatment of MAM. Both foods contained greater than 7% dairy protein, but the protein-optimized RUSF had a calculated digestible indispensable amino acid score (DIAAS) of 95%, whereas the control RUSF had a calculated DIAAS of 63%. There were 1,737 rural Malawian children 6-59 months of age treated with 75 kcal/kg/day of either control or protein quality-optimized RUSF for up to 12 weeks. There was no difference in the proportion of children who recovered from MAM between the group that received protein-optimized RUSF (759/860, 88%) and the group that received control RUSF (766/877, 87%, difference 1%, 95% CI, -2.1 to 4.1, p = 0.61). There were no differences in time to recovery or average weight gain; nor were adverse effects reported. Both RUSFs showed indistinguishable clinical outcomes, with recovery rates higher than typically seen in treatment for MAM. The DIAAS of these two RUSFs was measured using a pig model. Unexpectedly, the protein quality of the optimized RUSF was inferior to the control RUSF: DIAAS = 82% for the protein quality optimized RUSF and 96% for control RUSF. The controlled conditions of this trial suggest that in supplementary food products for MAM, protein quality is not an independent predictor of clinical effectiveness.",2020,"There was no difference in the proportion of children who recovered from MAM between the group that received protein-optimized RUSF (759/860, 88%) and the group that received control RUSF (766/877, 87%, difference 1%, 95% CI, -2.1 to 4.1, p = 0.61).","['moderate wasting', '1,737 rural Malawian children 6-59 months of age treated with 75 kcal/kg/day of either control or protein quality-optimized RUSF for up to 12 weeks']","['control RUSF', 'RUSFs']","['Protein quality', 'proportion of children who recovered from MAM', 'time to recovery or average weight gain', 'calculated digestible indispensable amino acid score (DIAAS']","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1690969', 'cui_str': 'Kcal/kg/day'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0002525', 'cui_str': 'Essential amino acid'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",1737.0,0.143598,"There was no difference in the proportion of children who recovered from MAM between the group that received protein-optimized RUSF (759/860, 88%) and the group that received control RUSF (766/877, 87%, difference 1%, 95% CI, -2.1 to 4.1, p = 0.61).","[{'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Roediger', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Washington University, St. Louis, Missouri, USA.'}, {'ForeName': 'Hans-Henrik', 'Initials': 'HH', 'LastName': 'Stein', 'Affiliation': 'Department of Animal Science, University of Illinois, Urbana, Illinois, USA.'}, {'ForeName': 'Meghan', 'Initials': 'M', 'LastName': 'Callaghan-Gillespie', 'Affiliation': 'Department of Pediatrics, Washington University, St. Louis, Missouri, USA.'}, {'ForeName': 'Jeffrey Kahn', 'Initials': 'JK', 'LastName': 'Blackman', 'Affiliation': 'Department of Pediatrics, Washington University, St. Louis, Missouri, USA.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Kohlmann', 'Affiliation': 'Department of Pediatrics, Washington University, St. Louis, Missouri, USA.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Maleta', 'Affiliation': 'Department of Community Health, College of Medicine, University of Malawi, Blantyre, Malawi.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Manary', 'Affiliation': 'Department of Pediatrics, Washington University, St. Louis, Missouri, USA.'}]",Maternal & child nutrition,['10.1111/mcn.13019']
913,23918212,Fenofibrate increases serum vaspin by upregulating its expression in adipose tissue.,"Fenofibrate is a peroxisome proliferator-activated receptor-α that has been clinically used to treat dyslipidemia and insulin resistance. To better understand the molecular mechanisms underlying fenofibrate action, we investigated whether fenofibrate affects serum levels of vaspin, an adipocytokine that has recently been shown to link obesity and insulin resistance. Fenofibrate treatment significantly increased serum vaspin levels of dyslipidemic patients, which correlated with reduced body weight and increased insulin sensitivity. To elucidate the biochemical mechanisms of fenofibrate action, we investigated the effect of fenofibrate on vaspin mRNA and protein expressions in obese rats. Fenofibrate greatly increased vaspin mRNA and protein levels in visceral adipose tissue consisting of retroperitoneal, mesenteric, and periepididymal adipose tissue but not in the subcutaneous adipose tissue, which correlated with increased serum vaspin levels and increased insulin sensitivity in obese rats. Consistent with a direct effect on vaspin expression, fenofibrate treatment significantly increased the mRNA and protein expression levels of vaspin in 3T3-L1 adipocytes. Together, our results demonstrate for the first time that fenofibrate upregulates vaspin expression in dyslipidemic human subjects and suggest that upregulation of vaspin expression in adipocytes may provide a mechanism by which fenofibrate improves insulin sensitivity in dyslipidemic patients.",2014,"Fenofibrate treatment significantly increased serum vaspin levels of dyslipidemic patients, which correlated with reduced body weight and increased insulin sensitivity.","['dyslipidemic human subjects', 'dyslipidemic patients', 'obese rats']","['Fenofibrate', 'fenofibrate']","['insulin sensitivity', 'serum vaspin levels', 'vaspin mRNA and protein levels', 'body weight and increased insulin sensitivity']","[{'cui': 'C0080105', 'cui_str': 'Human Subjects'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0034721', 'cui_str': 'Rats'}]","[{'cui': 'C0033228', 'cui_str': 'Fenofibrate'}]","[{'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0035696', 'cui_str': 'mRNA'}, {'cui': 'C0428479', 'cui_str': 'Protein level - finding'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",,0.0244301,"Fenofibrate treatment significantly increased serum vaspin levels of dyslipidemic patients, which correlated with reduced body weight and increased insulin sensitivity.","[{'ForeName': 'Mingwei', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': ""Institute of Endocrinology & Metabolism, Anhui Medical University, Hefei, People's Republic of China.""}, {'ForeName': 'Datong', 'Initials': 'D', 'LastName': 'Deng', 'Affiliation': ''}, {'ForeName': 'Zhaohui', 'Initials': 'Z', 'LastName': 'Fang', 'Affiliation': ''}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Xu', 'Affiliation': ''}, {'ForeName': 'Honglin', 'Initials': 'H', 'LastName': 'Hu', 'Affiliation': ''}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Luo', 'Affiliation': ''}, {'ForeName': 'Youmin', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ''}]",Endocrine,['10.1007/s12020-013-0023-y']
914,32072198,[Clinical implications of the PORTEC-3 trial for the treatment of high-risk endometrial cancer].,,2020,,['high-risk endometrial cancer'],[],[],"[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0476089', 'cui_str': 'Endometrial Carcinoma'}]",[],[],,0.0346619,,"[{'ForeName': 'Till', 'Initials': 'T', 'LastName': 'Waltar', 'Affiliation': 'Universitätsklinikum Köln, Köln, Deutschland.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Marnitz', 'Affiliation': 'Universitätsklinikum Köln, Köln, Deutschland. simone.marnitz-schulze@uk-koeln.de.'}]",Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al],['10.1007/s00066-020-01592-1']
915,31797549,Efficacy and safety of insulin glargine 300 U/mL versus insulin glargine 100 U/mL in Asia Pacific insulin-naïve people with type 2 diabetes: The EDITION AP randomized controlled trial.,"AIM


To compare the efficacy and safety of Gla-300 versus Gla-100 in insulin-naïve people with type 2 diabetes in Asia Pacific.
MATERIALS AND METHODS


In this open-label, randomized, active-controlled, 26-week study, insulin-naïve participants with type 2 diabetes inadequately controlled with non-insulin antihyperglycaemic drugs were randomized (2:1) to Gla-300 or Gla-100. The initial daily dose of basal insulin was 0.2 U/kg and was adjusted at least weekly for 8-12 weeks to a target fasting self-monitored plasma glucose (SMPG) of 4.4-5.6 mmol/L.
RESULTS


Of the 604 participants randomized, 570 (Gla-300, n = 375; Gla-100, n = 195) completed the study. Non-inferiority of Gla-300 versus Gla-100 in HbA1c reduction from baseline to week 26 was confirmed. In the Gla-300 and Gla-100 groups, 51.1% and 52.2% of participants achieved the HbA1c target of <7.0% (rate ratio [95% CI]: 0.98 [0.84 to 1.14]) and 19.1% and 21.9% achieved the target without hypoglycaemia during the last 12 weeks of treatment (rate ratio [95% CI]: 0.87 [0.63 to 1.20]). Changes in fasting plasma glucose and 24-hour average eight-point SMPG were comparable between groups. Incidence of hypoglycaemia at any time of day was similar between treatment groups at week 26, but incidence of any nocturnal hypoglycaemia was numerically lower with Gla-300 than Gla-100 over the initial 12-week titration period and 26-week on-treatment period. Rates of adverse events were similar between groups and low for serious adverse events.
CONCLUSIONS


Glycaemic control of Gla-300 is non-inferior to Gla-100 with a similar or lower incidence and proportion of hypoglycaemia in people with type 2 diabetes in Asia Pacific, reinforcing the results in the global EDITION programme.",2020,inferiority of Gla-300 versus Gla-100 in HbA 1c  reduction from baseline to week 26 was confirmed.,"['naïve participants with T2DM inadequately controlled with non-insulin antihyperglycaemic drugs', 'Asia Pacific Insulin-Naïve People with Type 2 Diabetes', '604 participants randomised, 570 (Gla-300 n=375; Gla-100 n=195) completed the study', 'insulin-naïve people with type 2 diabetes mellitus (T2DM) in Asia Pacific']","['Gla-300 or Gla-100', 'basal insulin', 'Gla-300 versus Gla-100', 'Insulin Glargine 300 U/mL versus Insulin Glargine 100', 'insulin']","['fasting plasma glucose and 24-hour average 8-point SMPG', 'efficacy and safety', 'target without hypoglycaemia', 'Rates of adverse events', 'Efficacy and Safety', 'Incidence of hypoglycaemia', 'anynocturnal hypoglycaemia']","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C2945590', 'cui_str': 'unit/mL'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",604.0,0.075098,inferiority of Gla-300 versus Gla-100 in HbA 1c  reduction from baseline to week 26 was confirmed.,"[{'ForeName': 'Linong', 'Initials': 'L', 'LastName': 'Ji', 'Affiliation': ""Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Eun Seok', 'Initials': 'ES', 'LastName': 'Kang', 'Affiliation': 'Severance Hospital, Yonsei University Health System, Seoul, Republic of Korea.'}, {'ForeName': 'XiaoLin', 'Initials': 'X', 'LastName': 'Dong', 'Affiliation': 'Jinan Central Hospital Affiliated to Shandong University, Shandong, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Shengjing Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'GuoYue', 'Initials': 'G', 'LastName': 'Yuan', 'Affiliation': 'Affiliated Hospital of Jiangsu University, Zhenjiang, China.'}, {'ForeName': 'Shuhua', 'Initials': 'S', 'LastName': 'Shang', 'Affiliation': 'Sanofi, Shanghai, China.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Niemoeller', 'Affiliation': 'Sanofi, Frankfurt, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Diabetes, obesity & metabolism",['10.1111/dom.13936']
916,32020287,A new method of near-infrared fluorescence image-guided hepatectomy for patients with hepatolithiasis: a randomized controlled trial.,"BACKGROUND


Hepatectomy is a definitive treatment for hepatolithiasis because it simultaneously removes intrahepatic duct (IHD) stones and biliary tract strictures together with the involved liver region en bloc. Unlike cystic or solid liver tumors, hepatolithiasis is usually associated with alterations of anatomical structures and perihepatic adhesions because of chronic recurrent inflammation. This complicates identification of the target hepatic region and location of biliary strictures.
METHODS


To determine the efficacy of near-infrared fluorescence (NIRF) imaging using indocyanine green (ICG), we performed a comparative trial and developed a white-light and near-infrared dual-channel image-guided device (DPM-I) for both open and endoscopic surgery. Forty-four eligible patients were randomly assigned to Group A (NIRF imaging) or Group B (traditional hepatectomy). We injected ICG via peripheral veins for patients in Group A.
RESULTS


The NIRF imaging method was associated with less blood loss (OR 1.004, 95% CI 0.999-1.010; P = 0.016), briefer hospitalization (OR 1.336, 95% CI 1.016-1.756; P = 0.001), lower rates of margins with dilated bile ducts (OR 1.278, 95% CI 1.030-1.585; P = 0.023), lower postoperative white blood cell counts (OR 1.262, 95% CI 0.931-1.712; P = 0.038), lower procalcitonin levels (OR 1.316, 95% CI 1.020-1.513; P = 0.002), and lower alanine aminotransferase levels (OR 1.013, 95% CI 1.003-1.023; P = 0.002) compared with traditional hepatectomy.
CONCLUSIONS


These data demonstrate the efficacy of NIRF imaging with ICG using DPM-I for treating hepatolithiasis.",2020,"The NIRF imaging method was associated with less blood loss (OR 1.004, 95% CI 0.999-1.010; P = 0.016), briefer hospitalization (OR 1.336, 95% CI 1.016-1.756; P = 0.001), lower rates of margins with dilated bile ducts (OR 1.278, 95% CI 1.030-1.585; P = 0.023), lower postoperative white blood cell counts (OR 1.262, 95% CI 0.931-1.712; P = 0.038), lower procalcitonin levels (OR 1.316, 95% CI 1.020-1.513; P = 0.002), and lower alanine aminotransferase levels (OR 1.013, 95% CI 1.003-1.023; P = 0.002) compared with traditional hepatectomy.
","['Forty-four eligible patients', 'patients with hepatolithiasis']","['white-light and near-infrared dual-channel image-guided device (DPM-I) for both open and endoscopic surgery', 'near-infrared fluorescence (NIRF) imaging using indocyanine green (ICG', 'near-infrared fluorescence image-guided hepatectomy', 'Group A (NIRF imaging) or Group B (traditional hepatectomy']","['lower procalcitonin levels', 'lower alanine aminotransferase levels', 'rates of margins with dilated bile ducts', 'blood loss', 'postoperative white blood cell counts', 'briefer hospitalization']","[{'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0563228', 'cui_str': 'White light (physical force)'}, {'cui': 'C0475806', 'cui_str': 'Nr - Near'}, {'cui': 'C1532326', 'cui_str': 'Infrared'}, {'cui': 'C0439799', 'cui_str': 'Channel (qualifier value)'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C1634619', 'cui_str': 'dpm'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0282493', 'cui_str': 'Surgical Procedures, Endoscopic'}, {'cui': 'C0430876', 'cui_str': 'Fluorescence Imaging'}, {'cui': 'C0021234', 'cui_str': 'Indocyanine Green'}, {'cui': 'C0016315', 'cui_str': 'Fluorescence'}, {'cui': 'C0019144', 'cui_str': 'Hepatectomy'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1535922', 'cui_str': 'Procalcitonin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement (procedure)'}, {'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}, {'cui': 'C0005400', 'cui_str': 'Bile Ducts'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0023508', 'cui_str': 'Blood Cell Count, White'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}]",44.0,0.207496,"The NIRF imaging method was associated with less blood loss (OR 1.004, 95% CI 0.999-1.010; P = 0.016), briefer hospitalization (OR 1.336, 95% CI 1.016-1.756; P = 0.001), lower rates of margins with dilated bile ducts (OR 1.278, 95% CI 1.030-1.585; P = 0.023), lower postoperative white blood cell counts (OR 1.262, 95% CI 0.931-1.712; P = 0.038), lower procalcitonin levels (OR 1.316, 95% CI 1.020-1.513; P = 0.002), and lower alanine aminotransferase levels (OR 1.013, 95% CI 1.003-1.023; P = 0.002) compared with traditional hepatectomy.
","[{'ForeName': 'Kunshan', 'Initials': 'K', 'LastName': 'He', 'Affiliation': 'The Fifth Affiliated Hospital, Sun Yat-sen University, Zhuhai, China.'}, {'ForeName': 'Xiaopeng', 'Initials': 'X', 'LastName': 'Hong', 'Affiliation': 'The Fifth Affiliated Hospital, Sun Yat-sen University, Zhuhai, China.'}, {'ForeName': 'Chongwei', 'Initials': 'C', 'LastName': 'Chi', 'Affiliation': 'Key Laboratory of Molecular Imaging, Institute of Automation, Chinese Academy of Sciences, Beijing, 100190, China.'}, {'ForeName': 'Chaonong', 'Initials': 'C', 'LastName': 'Cai', 'Affiliation': 'The Fifth Affiliated Hospital, Sun Yat-sen University, Zhuhai, China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Key Laboratory of Molecular Imaging, Institute of Automation, Chinese Academy of Sciences, Beijing, 100190, China.'}, {'ForeName': 'Peiping', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': 'The Fifth Affiliated Hospital, Sun Yat-sen University, Zhuhai, China.'}, {'ForeName': 'Xialei', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'The Fifth Affiliated Hospital, Sun Yat-sen University, Zhuhai, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'The Fifth Affiliated Hospital, Sun Yat-sen University, Zhuhai, China. lijian5@mail.sysu.edu.cn.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Shan', 'Affiliation': 'The Fifth Affiliated Hospital, Sun Yat-sen University, Zhuhai, China. shanhong@mail.sysu.edu.cn.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Tian', 'Affiliation': 'Beijing Advanced Innovation Center for Big Data-Based Precision Medicine, School of Medicine and Engineering, Beihang University, Beijing, 100191, China. jie.tian@ia.ac.cn.'}]",Surgical endoscopy,['10.1007/s00464-019-07290-z']
917,31916788,Online preschool teacher training to promote physical activity in young children: A pilot cluster randomized controlled trial.,"This study tested the Wellness Enhancing Physical Activity in Young Children (WE PLAY) program, a 4-week online preschool teacher training, on children's moderate-to-vigorous physical activity (MVPA). In this cluster RCT, six Head Start preschools were randomized to an intervention and comparison group. Children's MVPA was measured using accelerometers at pre- and posttest. The magnitude of the difference in MVPA between groups at posttest was small, but in the expected direction: Δ min/hour = 1.60, 95% CI [-0.97, 4.18], p = .22, Cohen's d = 0.32. We observed a pre/post within group increase in average minutes per hour of MVPA in school with a medium effect size for the intervention group: Δ mean min/hour = 2.09, 95% CI [0.51, 3.67], p = .0096, Cohen's d = 0.42. An increase was not seen for the comparison group: Δ mean min/hour = 0.44, 95% CI [-0.70, 1.59], p = .45, Cohen's d = 0.07. WE PLAY children in 6 hr/day programs gained 63 min of MVPA per week in school, providing preliminary evidence of the benefits of WE PLAY on children's physical activity levels. WE PLAY deserves further testing with larger groups of children and teachers. (PsycINFO Database Record (c) 2020 APA, all rights reserved).",2020,"An increase was not seen for the comparison group: Δ mean min/hour = 0.44, 95% CI [-0.70, 1.59], p = .45, Cohen's d = 0.07.","[""Young Children (WE PLAY) program, a 4-week online preschool teacher training, on children's moderate-to-vigorous physical activity (MVPA"", 'young children']","['Online preschool teacher training', 'MVPA']",['MVPA'],"[{'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C4082803', 'cui_str': 'Teacher Training'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C4082803', 'cui_str': 'Teacher Training'}]",[],2020.0,0.0794461,"An increase was not seen for the comparison group: Δ mean min/hour = 0.44, 95% CI [-0.70, 1.59], p = .45, Cohen's d = 0.07.","[{'ForeName': 'Jessica A', 'Initials': 'JA', 'LastName': 'Hoffman', 'Affiliation': 'Department of Applied Psychology, Northeastern University.'}, {'ForeName': 'Ellyn M', 'Initials': 'EM', 'LastName': 'Schmidt', 'Affiliation': 'Department of Applied Psychology, Northeastern University.'}, {'ForeName': 'Diego J', 'Initials': 'DJ', 'LastName': 'Arguello', 'Affiliation': 'Department of Health Sciences, Northeastern University.'}, {'ForeName': 'Mara N', 'Initials': 'MN', 'LastName': 'Eyllon', 'Affiliation': 'Department of Health Sciences, Northeastern University.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Castaneda-Sceppa', 'Affiliation': 'Department of Health Sciences, Northeastern University.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Cloutier', 'Affiliation': 'Department of Health Sciences, Northeastern University.'}, {'ForeName': 'Charles H', 'Initials': 'CH', 'LastName': 'Hillman', 'Affiliation': 'Department of Psychology, Northeastern University.'}]","School psychology (Washington, D.C.)",['10.1037/spq0000349']
918,31524770,Switching from branched-chain amino acid granules to branched-chain amino acid-enriched nutrient improves the branched-chain amino acid-to-tyrosine ratio in patients with cirrhosis with hypoalbuminemia: a prospective study.,"OBJECTIVE


The present study aimed to elucidate the effect of switching from branched-chain amino acid granules to branched-chain amino acid-enriched nutrient in patients with cirrhosis with hypoalbuminemia.
METHODS


Twenty-six patients with cirrhosis with hypoalbuminemia despite treatment with branched-chain amino acid granules containing 12 g of branched-chain amino acid were enrolled in the prospective study. The branched-chain amino acid-enriched nutrient and control groups were composed of 16 and 10 patients, respectively. The patients in branched-chain amino acid-enriched nutrient group switched to branched-chain amino acid-enriched nutrient mixture containing 12.2 g of branched-chain amino acid and 410 kcal with a half of it consumed as a late evening snack, and the patients in the control group continued branched-chain amino acid granules. Laboratory data related to nutrition parameter were assessed at baseline, 3 months after baseline, and at 6 months after baseline.
RESULTS


Two patients were withdrawn; hence, nine and 15 patients in the branched-chain amino acid granules and branched-chain amino acid-enriched nutrient groups, respectively, were subjected to full analysis. Serum albumin levels and total lymphocyte counts in both groups did not change in the study period. The branched-chain amino acid-to-tyrosine ratio in the branched-chain amino acid-enriched nutrient group significantly increased from baseline to 6 months after baseline (P = 0.030), whereas that in the control group did not increase.
CONCLUSION


Switching from branched-chain amino acid granules to branched-chain amino acid-enriched nutrients improves branched-chain amino acid-to-tyrosine ratio in patients with cirrhosis with hypoalbuminemia.",2020,Serum albumin levels and total lymphocyte counts in both groups did not change in the study period.,"['Two patients were withdrawn; hence, nine and 15 patients in the branched-chain amino acid granules and branched-chain amino acid-enriched nutrient groups, respectively, were subjected to full analysis', 'Twenty-six patients with cirrhosis with hypoalbuminemia despite treatment with branched-chain amino acid granules containing 12 g of branched-chain amino acid were enrolled in the prospective study', 'patients with cirrhosis with hypoalbuminemia']","['branched-chain amino acid-enriched nutrient group switched to branched-chain amino acid-enriched nutrient mixture containing 12.2 g of branched-chain amino acid', 'switching from branched-chain amino acid granules to branched-chain amino acid-enriched nutrient', 'control group continued branched-chain amino acid granules']",['Serum albumin levels and total lymphocyte counts'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn (finding)'}, {'cui': 'C0337112', 'cui_str': 'Chain, device (physical object)'}, {'cui': 'C3539946', 'cui_str': 'Amino acids'}, {'cui': 'C3853573', 'cui_str': 'Granules'}, {'cui': 'C0002521', 'cui_str': 'Amino Acids, Branched-Chain'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0450349', 'cui_str': '26 (qualifier value)'}, {'cui': 'C1623038', 'cui_str': 'Cirrhosis'}, {'cui': 'C0239981', 'cui_str': 'Hypoalbuminemia'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C1318183', 'cui_str': '12G'}, {'cui': 'C0033522', 'cui_str': 'Prospective Studies'}]","[{'cui': 'C0337112', 'cui_str': 'Chain, device (physical object)'}, {'cui': 'C3539946', 'cui_str': 'Amino acids'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0002521', 'cui_str': 'Amino Acids, Branched-Chain'}, {'cui': 'C0439962', 'cui_str': 'Mixture (qualifier value)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C3853573', 'cui_str': 'Granules'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0523465', 'cui_str': 'Albumin measurement, serum (procedure)'}, {'cui': 'C0200635', 'cui_str': 'Lymphocyte Number'}]",,0.207005,Serum albumin levels and total lymphocyte counts in both groups did not change in the study period.,"[{'ForeName': 'Aiko', 'Initials': 'A', 'LastName': 'Fukui', 'Affiliation': 'Faculty of Pharmacy, Meijo University, Nagoya.'}, {'ForeName': 'Naoto', 'Initials': 'N', 'LastName': 'Kawabe', 'Affiliation': 'Department of Liver, Biliary Tract and Pancreas Diseases, Fujita Health University, Toyoake, Japan.'}, {'ForeName': 'Senju', 'Initials': 'S', 'LastName': 'Hashimoto', 'Affiliation': 'Department of Liver, Biliary Tract and Pancreas Diseases, Fujita Health University, Toyoake, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Kamei', 'Affiliation': 'Faculty of Pharmacy, Meijo University, Nagoya.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Yoshioka', 'Affiliation': 'Department of Liver, Biliary Tract and Pancreas Diseases, Fujita Health University, Toyoake, Japan.'}]",European journal of gastroenterology & hepatology,['10.1097/MEG.0000000000001544']
919,31852482,The immune system in sporadic inclusion body myositis patients is not compromised by blood-flow restricted exercise training.,"BACKGROUND


Sporadic inclusion body myositis (sIBM) is clinically characterised by progressive proximal and distal muscle weakness and impaired physical function while skeletal muscle tissue displays abnormal cellular infiltration of T cells, macrophages, and dendritic cells. Only limited knowledge exists about the effects of low-load blood flow restriction exercise in sIBM patients, and its effect on the immunological responses at the myocellular level remains unknown. The present study is the first to investigate the longitudinal effects of low-load blood flow restriction exercise on innate and adaptive immune markers in skeletal muscle from sIBM patients.
METHODS


Twenty-two biopsy-validated sIBM patients were randomised into either 12 weeks of low-load blood flow restriction exercise (BFRE) or no exercise (CON). Five patients from the control group completed 12 weeks of BFRE immediately following participation in the 12-week control period leading to an intervention group of 16 patients. Muscle biopsies were obtained from either the m. tibialis anterior or the m. vastus lateralis for evaluation of CD3-, CD8-, CD68-, CD206-, CD244- and FOXP3-positive cells by three-colour immunofluorescence microscopy and Visiopharm-based image analysis quantification. A linear mixed model was used for the statistical analysis.
RESULTS


Myocellular infiltration of CD3 - /CD8 +  expressing natural killer cells increased following BFRE (P < 0.05) with no changes in CON. No changes were observed for CD3 + /CD8 -  or CD3 + /CD8 +  T cells in BFRE or CON. CD3 + /CD244 +  T cells decreased in CON, while no changes were observed in BFRE. Pronounced infiltration of M1 pro-inflammatory (CD68 + /CD206 - ) and M2 anti-inflammatory (CD68 + /CD206 + ) macrophages were observed at baseline; however, no longitudinal changes in macrophage content were observed for both groups.
CONCLUSIONS


Low-load blood flow restriction exercise elicited an upregulation in CD3 - /CD8 +  expressing natural killer cell content, which suggests that 12 weeks of BFRE training evokes an amplified immune response in sIBM muscle. However, the observation of no changes in macrophage or T cell infiltration in the BFRE-trained patients indicates that patients with sIBM may engage in this type of exercise with no risk of intensified inflammatory activity.",2019,"Pronounced infiltration of M1 pro-inflammatory (CD68 + /CD206 - ) and M2 anti-inflammatory (CD68 + /CD206 + ) macrophages were observed at baseline; however, no longitudinal changes in macrophage content were observed for both groups.
","['Twenty-two biopsy-validated sIBM patients', 'skeletal muscle from sIBM patients', 'sporadic inclusion body myositis patients']","['BFRE', 'low-load blood flow restriction exercise', 'low-load blood flow restriction exercise (BFRE) or no exercise (CON']","['CD3 + /CD244 +  T cells', 'macrophage or T cell infiltration', 'BFRE', 'macrophage content', 'Pronounced infiltration of M1 pro-inflammatory (CD68 + /CD206 - ) and M2 anti-inflammatory (CD68 + /CD206 + ) macrophages', 'CD3 + /CD8 -  or CD3 + /CD8 +  T cells']","[{'cui': 'C4284772', 'cui_str': '22 (qualifier value)'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0242692', 'cui_str': 'Muscle, Voluntary'}, {'cui': 'C0751713', 'cui_str': 'Inclusion Body Myopathy, Sporadic'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0024432', 'cui_str': 'Monocyte-Derived Macrophages'}, {'cui': 'C3669041', 'cui_str': 'Spread by direct extension (qualifier value)'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}]",22.0,0.0274145,"Pronounced infiltration of M1 pro-inflammatory (CD68 + /CD206 - ) and M2 anti-inflammatory (CD68 + /CD206 + ) macrophages were observed at baseline; however, no longitudinal changes in macrophage content were observed for both groups.
","[{'ForeName': 'Kasper Yde', 'Initials': 'KY', 'LastName': 'Jensen', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, SDU Muscle Research Cluster (SMRC), University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Mikkel', 'Initials': 'M', 'LastName': 'Jacobsen', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, SDU Muscle Research Cluster (SMRC), University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Henrik Daa', 'Initials': 'HD', 'LastName': 'Schrøder', 'Affiliation': 'Department of Pathology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Aagaard', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, SDU Muscle Research Cluster (SMRC), University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Jakob Lindberg', 'Initials': 'JL', 'LastName': 'Nielsen', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, SDU Muscle Research Cluster (SMRC), University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Anders Nørkær', 'Initials': 'AN', 'LastName': 'Jørgensen', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, SDU Muscle Research Cluster (SMRC), University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Eleanor', 'Initials': 'E', 'LastName': 'Boyle', 'Affiliation': 'Department of Sport Science and Clinical Biomechanics, Research Unit of Clinical Biomechanics, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Rune Dueholm', 'Initials': 'RD', 'LastName': 'Bech', 'Affiliation': 'Department of Orthopaedics and Traumatology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Sofie', 'Initials': 'S', 'LastName': 'Rosmark', 'Affiliation': 'Department of Rheumatology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Louise Pyndt', 'Initials': 'LP', 'LastName': 'Diederichsen', 'Affiliation': 'Department of Rheumatology, Odense University Hospital, Odense, Denmark. louise.diederichsen@regionh.dk.'}, {'ForeName': 'Ulrik', 'Initials': 'U', 'LastName': 'Frandsen', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, SDU Muscle Research Cluster (SMRC), University of Southern Denmark, Odense, Denmark.'}]",Arthritis research & therapy,['10.1186/s13075-019-2036-2']
920,32095819,Letter to the Editor: Antibiotic Cocktail for Pediatric Acute Severe Colitis and the Microbiome: The PRASCO Randomized Controlled Trial.,,2020,,['Pediatric Acute Severe Colitis and the Microbiome'],"['Antibiotic Cocktail', 'Letter to the Editor']",[],"[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0009319', 'cui_str': 'Colitis'}, {'cui': 'C1956108', 'cui_str': 'Microbiome'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0678420', 'cui_str': 'Alcoholic mixed drink'}, {'cui': 'C1096774', 'cui_str': 'Letter'}]",[],,0.0978371,,"[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Gilmore', 'Affiliation': 'Department of Gastroenterology, Austin Health, Melbourne, Australia.'}, {'ForeName': 'Matthew C', 'Initials': 'MC', 'LastName': 'Choy', 'Affiliation': 'Department of Gastroenterology, Austin Health, Melbourne, Australia.'}, {'ForeName': 'Christopher F D', 'Initials': 'CFD', 'LastName': 'Li Wai Suen', 'Affiliation': 'Department of Gastroenterology, Austin Health, Melbourne, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'De Cruz', 'Affiliation': 'Department of Gastroenterology, Austin Health, Melbourne, Australia.'}]",Inflammatory bowel diseases,['10.1093/ibd/izaa038']
921,32421909,Contrasting Personal Characteristics and Psychosocial Correlates of Exercise and Eating Behavior Changes in Women Successful vs. Unsuccessful with Weight Loss and Maintenance.,"BACKGROUND


There is great variability in individuals' responses to behavioral weight-loss treatments. Beyond attaining meaningful weight loss in the initial several weeks, little is known of the characteristics of participants successful vs. unsuccessful with short- and long-term weight loss.
METHODS


Separate samples of women with obesity enrolled in cognitive-behavioral weight-loss treatments were assessed over 6 months (Study 1: successful weight-loss group, n = 83; unsuccessful group, n = 158), and over 24 months (Study 2: sustained initially lost weight, n = 25; regained weight, n = 19), on personal characteristics and theory-driven psychosocial variables.
RESULTS


In Study 1, significantly older age and greater eating self-regulation at baseline were found in the successful group. Significantly greater improvements in exercise- and eating-related self-regulation, mood, exercise- and eating-related self-efficacy, physical self-concept, and body satisfaction were found in the successful group. In Study 2, the sustainer group had significantly more favorable changes over 2 years in exercise- and eating-related self-regulation, and mood. During Months 6-24, the psychosocial correlates of both exercise and eating behaviors regressed, with more pronounced reversions in the regainer group.
CONCLUSION


Increasing the magnitude of treatment-associated improvement in each of the tested theory-based psychosocial factors is warranted to increase probabilities for success with attaining and maintaining meaningful weight loss.",2020,"Significantly greater improvements in exercise- and eating-related self-regulation, mood, exercise- and eating-related self-efficacy, physical self-concept, and body satisfaction were found in the successful group.","['Separate samples of women with obesity enrolled in cognitive-behavioral weight-loss treatments were assessed over 6\xa0months (Study 1: successful weight-loss group, n\xa0=\xa083; unsuccessful group, n\xa0=\xa0158), and over 24\xa0months (Study 2: sustained initially lost weight, n\xa0=\xa025; regained weight, n\xa0=\xa019), on personal characteristics and theory-driven psychosocial variables']",[],"['exercise- and eating-related self-regulation, mood, exercise- and eating-related self-efficacy, physical self-concept, and body satisfaction', 'eating self-regulation']","[{'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1272705', 'cui_str': 'Unsuccessful'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0033963', 'cui_str': 'Psychosocial Factors'}]",[],"[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0036594', 'cui_str': 'Self Concept'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",,0.0336377,"Significantly greater improvements in exercise- and eating-related self-regulation, mood, exercise- and eating-related self-efficacy, physical self-concept, and body satisfaction were found in the successful group.","[{'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Annesi', 'Affiliation': 'YMCA of Metro Atlanta, Atlanta, GA, USA.'}]",Applied psychology. Health and well-being,['10.1111/aphw.12203']
922,32430395,Thrombolysis with alteplase 3-4.5 hours after acute ischaemic stroke: trial reanalysis adjusted for baseline imbalances.,"OBJECTIVES


Alteplase is commonly recommended for acute ischaemic stroke within 4.5 hours after stroke onset. The Third European Cooperative Acute Stroke Study (ECASS III) is the only trial reporting statistically significant efficacy for clinical outcomes for alteplase use 3-4.5 hours after stroke onset. However, baseline imbalances in history of prior stroke and stroke severity score may confound this apparent finding of efficacy. We reanalysed the ECASS III trial data adjusting for baseline imbalances to determine the robustness or sensitivity of the efficacy estimates.
DESIGN


Reanalysis of randomised placebo-controlled trial. We obtained access to the ECASS III trial data and replicated the previously reported analyses to confirm our understanding of the data. We adjusted for baseline imbalances using multivariable analyses and stratified analyses and performed sensitivity analysis for missing data.
SETTING


Emergency care.
PARTICIPANTS


821 adults with acute ischaemic stroke who could be treated 3-4.5 hours after symptom onset.
INTERVENTIONS


Intravenous alteplase (0.9 mg/kg of body weight) or placebo.
MAIN OUTCOME MEASURES


The original primary efficacy outcome was modified Rankin Scale (mRS) score 0 or 1 (ie, being alive without any disability) and the original secondary efficacy outcome was a global outcome based on a composite of functional end points, both at 90 days. Adjusted analyses were only reported for the primary efficacy outcome and the original study protocol did not specify methods for adjusted analyses. Our adjusted reanalysis included these outcomes, symptom-free status (mRS 0), dependence-free status (mRS 0-2), mortality (mRS 6) and change across the mRS 0-6 spectrum at 90 days; and mortality and symptomatic intracranial haemorrhage at 7 days.
RESULTS


We replicated previously reported unadjusted analyses but discovered they were based on a modified interpretation of the National Institutes of Health Stroke Scale (NIHSS) score. The secondary efficacy outcome was no longer significant using the original NIHSS score. Previously reported adjusted analyses could only be replicated with significant effects for the primary efficacy outcome by using statistical approaches not reported in the trial protocol or statistical analysis plan. In analyses adjusting for baseline imbalances, all efficacy outcomes were not significant, but increases in symptomatic intracranial haemorrhage remained significant.
CONCLUSIONS


Reanalysis of the ECASS III trial data with multiple approaches adjusting for baseline imbalances does not support any significant benefits and continues to support harms for the use of alteplase 3-4.5 hours after stroke onset. Clinicians, patients and policymakers should reconsider interpretations and decisions regarding management of acute ischaemic stroke that were based on ECASS III results.
TRIAL REGISTRATION NUMBER


NCT00153036.",2020,"In analyses adjusting for baseline imbalances, all efficacy outcomes were not significant, but increases in symptomatic intracranial haemorrhage remained significant.
","['Emergency care', '821 adults with acute ischaemic stroke who could be treated 3-4.5\u2009hours after symptom onset']","['Intravenous alteplase', 'placebo']","['original NIHSS score', 'Health Stroke Scale (NIHSS) score', 'symptomatic intracranial haemorrhage', 'modified Rankin Scale (mRS) score 0 or 1 (ie, being alive without any disability', 'symptom-free status (mRS 0), dependence-free status (mRS 0-2), mortality (mRS 6) and change across the mRS 0-6 spectrum at 90 days; and mortality and symptomatic intracranial haemorrhage']","[{'cui': 'C0013961', 'cui_str': 'Emergency medical services'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C3844009', 'cui_str': '4.5'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0151699', 'cui_str': 'Intracranial hemorrhage'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0436342', 'cui_str': 'Free of symptoms'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0011546', 'cui_str': 'Dependency, Psychology'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",821.0,0.293191,"In analyses adjusting for baseline imbalances, all efficacy outcomes were not significant, but increases in symptomatic intracranial haemorrhage remained significant.
","[{'ForeName': 'Brian Scott', 'Initials': 'BS', 'LastName': 'Alper', 'Affiliation': 'Medical Knowledge Office, EBSCO Information Services, Ipswich, Massachusetts, USA balper@ebsco.com.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Foster', 'Affiliation': ""Biostatistics, St Joseph's Healthcare, Hamilton, Ontario, Canada.""}, {'ForeName': 'Lehana', 'Initials': 'L', 'LastName': 'Thabane', 'Affiliation': ""Biostatistics, St Joseph's Healthcare, Hamilton, Ontario, Canada.""}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Rae-Grant', 'Affiliation': 'DynaMed, EBSCO Health, Ipswich, Massachusetts, USA.'}, {'ForeName': 'Meghan', 'Initials': 'M', 'LastName': 'Malone-Moses', 'Affiliation': 'Innovations and Evidence-Based Medicine Development, EBSCO Health, Ipswich, Massachusetts, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Manheimer', 'Affiliation': 'Innovations and Evidence-Based Medicine Development, EBSCO Health, Ipswich, Massachusetts, USA.'}]",BMJ evidence-based medicine,['10.1136/bmjebm-2020-111386']
923,31443958,"Re: Jonas Hugosson, Monique J. Roobol, Marianne Månsson, et al. A 16-yr Follow-up of the European Randomized Study of Screening for Prostate Cancer. Eur Urol 2019;76:43-51: Mortality in the Age Group ≥70 yr and the Case of Italy.",,2020,,[],[],[],[],[],[],,0.0347834,,"[{'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Donzelli', 'Affiliation': 'Fondazione Allineare Sanità e Salute, Milan, Italy. Electronic address: adonzelli1@libero.it.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Castelluzzo', 'Affiliation': 'Department of Hygiene, Public Health and Preventive Medicine, University of Milano-Bicocca, Milan, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Giudicatti', 'Affiliation': 'Department of Hygiene, Public Health and Preventive Medicine, University of Milano-Bicocca, Milan, Italy.'}]",European urology,['10.1016/j.eururo.2019.07.045']
924,20445999,Risk factors for deep surgical site infections after spinal fusion.,"Surgical site infections (SSI) are undesired and troublesome complications after spinal surgery. The reported infection rates range from 0.7 to 11.9%, depending on the diagnosis and the complexity of the procedure. Besides operative factors, patient characteristics could also account for increased infection rates. Because the medical, economic and social costs of SSI are enormous, any significant reduction in risks will pay dividends. The purpose of this study is to compare patients who developed deep SSI following lumbar or thoracolumbar spinal fusion with a randomly selected group of patients who did not develop this complication in order to identify changeable risk factors. With a case-control analysis nested in a historical cohort of patients who had had a spinal fusion between January 1999 and December 2008, we identified 36 cases with deep SSI (CDC criteria). Information regarding patient-level and surgical-level risk factors was derived from standardized but routinely recorded data and compared with those acquired in a random selection of 135 uninfected patients. Univariate analyses and a multivariate logistic regression were performed. The overall rate of infection in 1,615 procedures (1,568 patients) was 2.2%. A positive history of spinal surgery was associated with an almost four times higher infection rate (OR = 3.7, 95% BI = 1.6-8.6). The risk of SSI increased with the number of levels fused, patients with diabetes had an almost six times higher risk and smokers had more than a two times higher risk for deep SSI. The most common organism cultured was Staphylococcus aureus. All infected patients underwent at least one reoperation, including an open débridement and received appropriate antibiotics to treat the organism. Patients who had had a previous spinal surgery are a high-risk group for infection compared with those that never had surgery. Total costs associated with preventive measures are substantial and should be compensated by health care insurance companies by means of separate clinical pathways. High-risk patients should be informed about the increased risk of complications.",2010,"A positive history of spinal surgery was associated with an almost four times higher infection rate (OR = 3.7, 95% BI = 1.6-8.6).","['historical cohort of patients who had had a spinal fusion between January 1999 and December 2008, we identified 36 cases with deep SSI (CDC criteria', 'patients who developed deep SSI following lumbar or thoracolumbar spinal fusion with a randomly selected group of patients who did not develop this complication in order to identify changeable risk factors', 'High-risk patients', 'Patients who had had a previous spinal surgery are a high-risk group for infection compared with those that never had surgery', 'deep surgical site infections after spinal fusion', '135 uninfected patients']",[],"['infection rates range', 'overall rate of infection', 'risk of SSI', 'infection rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0037935', 'cui_str': 'Spinal Fusion'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0007670', 'cui_str': 'CDC'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0024090', 'cui_str': 'Lumbar Region'}, {'cui': 'C0450219', 'cui_str': 'Thoracolumbar (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1292718', 'cui_str': 'Is a'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0038941', 'cui_str': 'Postoperative Wound Infection'}, {'cui': 'C4517566', 'cui_str': '135'}]",[],"[{'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",135.0,0.0304192,"A positive history of spinal surgery was associated with an almost four times higher infection rate (OR = 3.7, 95% BI = 1.6-8.6).","[{'ForeName': 'J J P', 'Initials': 'JJ', 'LastName': 'Schimmel', 'Affiliation': 'Department of Research Development and Education, Sint Maartenskliniek, PO Box 9011, 6500 GM Nijmegen, The Netherlands. j.schimmel@maartenskliniek.nl'}, {'ForeName': 'P P', 'Initials': 'PP', 'LastName': 'Horsting', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'de Kleuver', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Wonders', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'van Limbeek', 'Affiliation': ''}]","European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society",['10.1007/s00586-010-1421-y']
925,19902277,"Plasma disc decompression for contained cervical disc herniation: a randomized, controlled trial.","Prospective case series studies have shown that plasma disc decompression (PDD) using the COBLATION SpineWand device (ArthroCare Corporation, Austin, TX) is effective for decompressing the disc nucleus in symptomatic contained cervical disc herniations. This prospective, randomized controlled clinical trial was conducted to evaluate the clinical outcomes of percutaneous PDD as compared to conservative care (CC) through 1 year. Patients (n = 115) had neck/arm pain >50 on the visual analog scale (VAS) pain scale and had failed at least 30 days of failed CC. Patients were randomly assigned to receive either PDD (n = 62) or CC (n = 58). Clinical outcome was determined by VAS pain score, neck disability index (NDI) score, and SF-36 health survey, collected at 6 weeks, 3 months, 6 months, and 1 year. The PDD group had significantly lower VAS pain scores at all follow-up time points (PDD vs. CC: 6 weeks, -46.87 +/- 2.71 vs. -15.26 +/- 1.97; 3 months, -53.16 +/- 2.74 vs. -30.45 +/- 2.59; 6 months, -56.22 +/- 2.63 vs. -40.26 +/- 2.56; 1 year, -65.73 +/- 2.24 vs. -36.45 +/- 2.86; GEE, P < 0.0001). PDD patients also had significant NDI score improvement over baseline when compared to CC patients at the 6 weeks (PDD vs. CC: -9.15 +/- 1.06 vs. -4.61 +/- 0.53, P < 0.0001) and 1 year (PDD vs. CC: -16.70 +/- 0.29 vs. -12.40 +/- 1.26, P = 0.005) follow-ups. PDD patients showed statistically significant improvement over baseline in SF-36 physical component summary scores when compared to CC patients at 6 weeks and 1 year (PDD vs. CC: 8.86 + 8.04 vs. 4.24 +/- 3.79, P = 0.0004; 17.64 +/- 10.37 vs. 10.50 +/- 10.6, P = 0.0003, respectively). In patients who had neck/arm pain due to a contained cervical disc herniation, PDD was associated with significantly better clinical outcomes than a CC regimen. At 1 year, CC patients appeared to suffer a ""relapse, showing signs of decline in most measurements, whereas PDD patients showed continued stable improvement.",2010,PDD patients showed statistically significant improvement over baseline in SF-36 physical component summary scores when compared to CC patients at 6 weeks and 1 year (PDD vs. CC: 8.86 + 8.04 vs. 4.24 +/-,"['Patients (n = 115) had neck/arm pain >50 on the', 'contained cervical disc herniation']","['percutaneous PDD', 'CC', 'plasma disc decompression (PDD) using the COBLATION SpineWand device (ArthroCare Corporation, Austin, TX', 'PDD', 'Plasma disc decompression']","['SF-36 physical component summary scores', 'visual analog scale (VAS) pain scale', 'VAS pain scores', 'relapse', 'NDI score improvement', 'VAS pain score, neck disability index (NDI) score, and SF-36 health survey']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517540', 'cui_str': '115 (qualifier value)'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0410619', 'cui_str': 'Prolapsed cervical intervertebral disc (disorder)'}]","[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach - access (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C1705370', 'cui_str': 'Disc - unit of product usage'}, {'cui': 'C1829459', 'cui_str': 'Decompression (procedure)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0605411', 'cui_str': 'austin'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C2959538', 'cui_str': 'Neck disability index score'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}]",115.0,0.075087,PDD patients showed statistically significant improvement over baseline in SF-36 physical component summary scores when compared to CC patients at 6 weeks and 1 year (PDD vs. CC: 8.86 + 8.04 vs. 4.24 +/-,"[{'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Cesaroni', 'Affiliation': 'Policlinico Casilino, U.O.C. Neurochirurgica, Via Casilina, 1049-00169 Rome, Italy. acesaro@tin.it'}, {'ForeName': 'Pier Vittorio', 'Initials': 'PV', 'LastName': 'Nardi', 'Affiliation': ''}]","European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society",['10.1007/s00586-009-1189-0']
926,32428341,"Changing Sedentary Behavior in the Office: A Randomised Controlled Trial Comparing the Effect of Affective, Instrumental, and Self-Regulatory Messaging on Sitting.","BACKGROUND


Although avoiding sedentary behavior has many health benefits, adults often sit for long periods at work. The purpose of this study was to compare affective attitude, instrumental attitude, and self-regulation messaging interventions on sitting in the workplace.
METHODS


Using a cluster randomised controlled trial design, participants (N = 116) were assigned (by workplace) to: (a) instrumental, (b) affective, (c) self-regulation, or (d) control (nutrition information) groups. Measurements were taken online at baseline, 4 weeks, 8 weeks, and 12 weeks post-baseline. The interventions comprised three presentations delivered following baseline, week 4, and week 8 assessments. The primary outcome was self-reported average hours of sitting per day at work (registered trial number: NCT04082624).
RESULTS


Controlling for baseline sitting, overall, the affective group sat for less time than the instrumental and self-regulation groups. Also, at week 4, the affective group sat for less time than the instrumental and self-regulation groups and, at week 8, the affective group sat for less time than the self-regulation and control groups. There were no differences between the groups at week 12.
CONCLUSIONS


This investigation showed that workplace interventions targeting affective attitude can lead to less sitting time in the short term. Future research should explore additional strategies to minimise sedentary behavior in the long term.",2020,"RESULTS


Controlling for baseline sitting, overall, the affective group sat for less time than the instrumental and self-regulation groups.",['participants (N\xa0=\xa0116'],[],"['sitting time', 'self-reported average hours of sitting per day at work (registered trial number: NCT04082624']","[{'cui': 'C4517541', 'cui_str': '116'}]",[],"[{'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",116.0,0.0563669,"RESULTS


Controlling for baseline sitting, overall, the affective group sat for less time than the instrumental and self-regulation groups.","[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Lithopoulos', 'Affiliation': 'University of Victoria, Victoria, BC, Canada.'}, {'ForeName': 'Navin', 'Initials': 'N', 'LastName': 'Kaushal', 'Affiliation': 'Indiana University, Indianapolis, IN, USA.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Beauchamp', 'Affiliation': 'University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Conner', 'Affiliation': 'University of Leeds, Leeds, West Yorkshire, UK.'}, {'ForeName': 'Gert-Jan', 'Initials': 'GJ', 'LastName': 'de Bruijn', 'Affiliation': 'University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Amy E', 'Initials': 'AE', 'LastName': 'Latimer-Cheung', 'Affiliation': ""Queen's University, Kingston, ON, Canada.""}, {'ForeName': 'Ryan E', 'Initials': 'RE', 'LastName': 'Rhodes', 'Affiliation': 'University of Victoria, Victoria, BC, Canada.'}]",Applied psychology. Health and well-being,['10.1111/aphw.12202']
927,31522849,"Sustained outcomes in oral immunotherapy for peanut allergy (POISED study): a large, randomised, double-blind, placebo-controlled, phase 2 study.","BACKGROUND


Dietary avoidance is recommended for peanut allergies. We evaluated the sustained effects of peanut allergy oral immunotherapy (OIT) in a randomised long-term study in adults and children.
METHODS


In this randomised, double-blind, placebo-controlled, phase 2 study, we enrolled participants at the Sean N Parker Center for Allergy and Asthma Research at Stanford University (Stanford, CA, USA) with peanut allergy aged 7-55 years with a positive result from a double-blind, placebo-controlled, food challenge (DBPCFC; ≤500 mg of peanut protein), a positive skin-prick test (SPT) result (≥5 mm wheal diameter above the negative control), and peanut-specific immunoglobulin (Ig)E concentration of more than 4 kU/L. Participants were randomly assigned (2·4:1·4:1) in a two-by-two block design via a computerised system to be built up and maintained on 4000 mg peanut protein through to week 104 then discontinued on peanut (peanut-0 group), to be built up and maintained on 4000 mg peanut protein through to week 104 then to ingest 300 mg peanut protein daily (peanut-300 group) for 52 weeks, or to receive oat flour (placebo group). DBPCFCs to 4000 mg peanut protein were done at baseline and weeks 104, 117, 130, 143, and 156. The pharmacist assigned treatment on the basis of a randomised computer list. Peanut or placebo (oat) flour was administered orally and participants and the study team were masked throughout by use of oat flour that was similar in look and feel to the peanut flour and nose clips, as tolerated, to mask taste. The statistician was also masked. The primary endpoint was the proportion of participants who passed DBPCFCs to a cumulative dose of 4000 mg at both 104 and 117 weeks. The primary efficacy analysis was done in the intention-to-treat population. Safety was assessed in the intention-to-treat population. This trial is registered at ClinicalTrials.gov, NCT02103270.
FINDINGS


Between April 15, 2014, and March 2, 2016, of 152 individuals assessed, we enrolled 120 participants, who were randomly assigned to the peanut-0 (n=60), peanut-300 (n=35), and placebo groups (n=25). 21 (35%) of peanut-0 group participants and one (4%) placebo group participant passed the 4000 mg challenge at both 104 and 117 weeks (odds ratio [OR] 12·7, 95% CI 1·8-554·8; p=0·0024). Over the entire study, the most common adverse events were mild gastrointestinal symptoms, which were seen in 90 of 120 patients (50/60 in the peanut-0 group, 29/35 in the peanut-300 group, and 11/25 in the placebo group) and skin disorders, which were seen in 50/120 patients (26/60 in the peanut-0 group, 15/35 in the peanut-300 group, and 9/25 in the placebo group). Adverse events decreased over time in all groups. Two participants in the peanut groups had serious adverse events during the 3-year study. In the peanut-0 group, in which eight (13%) of 60 participants passed DBPCFCs at week 156, higher baseline peanut-specific IgG4 to IgE ratio and lower Ara h 2 IgE and basophil activation responses were associated with sustained unresponsiveness. No treatment-related deaths occurred.
INTERPRETATION


Our study suggests that peanut OIT could desensitise individuals with peanut allergy to 4000 mg peanut protein but discontinuation, or even reduction to 300 mg daily, could increase the likelihood of regaining clinical reactivity to peanut. Since baseline blood tests correlated with week 117 treatment outcomes, this study might aid in optimal patient selection for this therapy.
FUNDING


National Institute of Allergy and Infectious Diseases.",2019,"Our study suggests that peanut OIT could desensitise individuals with peanut allergy to 4000 mg peanut protein but discontinuation, or even reduction to 300 mg daily, could increase the likelihood of regaining clinical reactivity to peanut.","['enrolled participants at the Sean N Parker Center for Allergy and Asthma Research at Stanford University (Stanford, CA, USA) with peanut allergy aged 7-55 years with a positive result from a double-blind, placebo-controlled, food challenge (DBPCFC; ≤500 mg of peanut protein), a positive skin-prick test (SPT) result (≥5 mm wheal diameter above the negative control), and peanut-specific immunoglobulin (Ig)E concentration of more than 4 kU/L. Participants', 'adults and children', 'Between April 15, 2014, and March 2, 2016, of 152 individuals assessed, we enrolled 120 participants']","['oat flour (placebo', 'oral immunotherapy', 'placebo', 'DBPCFCs', 'Peanut or placebo (oat) flour', 'peanut allergy oral immunotherapy (OIT']","['proportion of participants who passed DBPCFCs', 'Safety', 'Adverse events', 'skin disorders', 'serious adverse events', 'baseline peanut-specific IgG4 to IgE ratio and lower Ara h 2 IgE and basophil activation responses']","[{'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0002111', 'cui_str': 'Allergy Specialty'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0035168'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0559470', 'cui_str': 'Groundnut Hypersensitivity'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0030736', 'cui_str': 'Peanuts'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0430561', 'cui_str': 'Prick test (procedure)'}, {'cui': 'C0221232', 'cui_str': 'Wheal'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C1270751', 'cui_str': 'Arachis hypogaea specific immunoglobulin E (substance)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0439340', 'cui_str': 'kU/L'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}]","[{'cui': 'C0028753', 'cui_str': 'Oats (substance)'}, {'cui': 'C0016260', 'cui_str': 'Flour'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0021083', 'cui_str': 'Immunotherapy'}, {'cui': 'C0030736', 'cui_str': 'Peanuts'}, {'cui': 'C0559470', 'cui_str': 'Groundnut Hypersensitivity'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0037274', 'cui_str': 'Dermatoses'}, {'cui': 'C0030736', 'cui_str': 'Peanuts'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0020860', 'cui_str': 'IgG4'}, {'cui': 'C0202086', 'cui_str': 'Immunoglobulin E measurement (procedure)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0063241', 'cui_str': 'hypoxanthine arabinoside'}, {'cui': 'C4316898', 'cui_str': 'Basophil, segmented (cell)'}]",120.0,0.566722,"Our study suggests that peanut OIT could desensitise individuals with peanut allergy to 4000 mg peanut protein but discontinuation, or even reduction to 300 mg daily, could increase the likelihood of regaining clinical reactivity to peanut.","[{'ForeName': 'R Sharon', 'Initials': 'RS', 'LastName': 'Chinthrajah', 'Affiliation': 'Sean N Parker Center for Allergy and Asthma Research, Stanford University, Stanford, CA, USA; Department of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Purington', 'Affiliation': 'Sean N Parker Center for Allergy and Asthma Research, Stanford University, Stanford, CA, USA; Department of Medicine, Stanford University, Stanford, CA, USA; Quantitative Sciences Unit, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Andorf', 'Affiliation': 'Sean N Parker Center for Allergy and Asthma Research, Stanford University, Stanford, CA, USA; Department of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Long', 'Affiliation': 'Sean N Parker Center for Allergy and Asthma Research, Stanford University, Stanford, CA, USA; Department of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Katherine L', 'Initials': 'KL', 'LastName': ""O'Laughlin"", 'Affiliation': 'Sean N Parker Center for Allergy and Asthma Research, Stanford University, Stanford, CA, USA; Department of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Shu Chen', 'Initials': 'SC', 'LastName': 'Lyu', 'Affiliation': 'Sean N Parker Center for Allergy and Asthma Research, Stanford University, Stanford, CA, USA; Department of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Monali', 'Initials': 'M', 'LastName': 'Manohar', 'Affiliation': 'Sean N Parker Center for Allergy and Asthma Research, Stanford University, Stanford, CA, USA; Department of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Boyd', 'Affiliation': 'Sean N Parker Center for Allergy and Asthma Research, Stanford University, Stanford, CA, USA; Department of Pathology, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Tibshirani', 'Affiliation': 'Department of Biomedical Data Sciences, Stanford University, Stanford, CA, USA; Department of Statistics, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Holden', 'Initials': 'H', 'LastName': 'Maecker', 'Affiliation': 'Sean N Parker Center for Allergy and Asthma Research, Stanford University, Stanford, CA, USA; Department of Microbiology and Immunology, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Marshall', 'Initials': 'M', 'LastName': 'Plaut', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, Bethesda, MD, USA.'}, {'ForeName': 'Kaori', 'Initials': 'K', 'LastName': 'Mukai', 'Affiliation': 'Sean N Parker Center for Allergy and Asthma Research, Stanford University, Stanford, CA, USA; Department of Pathology, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Mindy', 'Initials': 'M', 'LastName': 'Tsai', 'Affiliation': 'Sean N Parker Center for Allergy and Asthma Research, Stanford University, Stanford, CA, USA; Department of Pathology, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Manisha', 'Initials': 'M', 'LastName': 'Desai', 'Affiliation': 'Quantitative Sciences Unit, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Galli', 'Affiliation': 'Sean N Parker Center for Allergy and Asthma Research, Stanford University, Stanford, CA, USA; Department of Pathology, Stanford University, Stanford, CA, USA; Department of Microbiology and Immunology, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Kari C', 'Initials': 'KC', 'LastName': 'Nadeau', 'Affiliation': 'Sean N Parker Center for Allergy and Asthma Research, Stanford University, Stanford, CA, USA; Department of Medicine, Stanford University, Stanford, CA, USA. Electronic address: knadeau@stanford.edu.'}]","Lancet (London, England)",['10.1016/S0140-6736(19)31793-3']
928,31956263,Modulation of blood pressure-lowering effects of dark chocolate according to an insulin sensitivity-randomized crossover study.,,2020,,[],['dark chocolate'],[],[],"[{'cui': 'C3853217', 'cui_str': 'Dark chocolate (substance)'}]",[],,0.0609042,,"[{'ForeName': 'Chisa', 'Initials': 'C', 'LastName': 'Matsumoto', 'Affiliation': 'Department of Cardiology, Tokyo Medical University, Tokyo, Japan.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Tomiyama', 'Affiliation': 'Department of Cardiology, Tokyo Medical University, Tokyo, Japan. tomiyama@tokyo-med.ac.jp.'}, {'ForeName': 'Kazutaka', 'Initials': 'K', 'LastName': 'Kimura', 'Affiliation': 'Department of Cardiology, Tokyo Medical University, Tokyo, Japan.'}, {'ForeName': 'Kazuki', 'Initials': 'K', 'LastName': 'Shiina', 'Affiliation': 'Department of Cardiology, Tokyo Medical University, Tokyo, Japan.'}, {'ForeName': 'Masanori', 'Initials': 'M', 'LastName': 'Kamei', 'Affiliation': 'Morinaga & Co., Ltd., R&D Institute, Kanagawa, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Inagaki', 'Affiliation': 'Morinaga & Co., Ltd., R&D Institute, Kanagawa, Japan.'}, {'ForeName': 'Taishirou', 'Initials': 'T', 'LastName': 'Chikamori', 'Affiliation': 'Department of Cardiology, Tokyo Medical University, Tokyo, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Yamshina', 'Affiliation': 'Department of Cardiology, Tokyo Medical University, Tokyo, Japan.'}]",Hypertension research : official journal of the Japanese Society of Hypertension,['10.1038/s41440-020-0395-3']
929,31523888,Supplementing teacher knowledge using web-based Intelligent Tutoring System for the Text Structure Strategy to improve content area reading comprehension with fourth- and fifth-grade struggling readers.,"The effects of teaching the text structure strategy using a web-based Intelligent Tutoring System for the Text Structure Strategy (ITSS) were examined with fourth- and fifth-grade children scoring below the 25th percentile on comprehension measures using the Gray Silent Reading Test (GSRT) and researcher designed assessment from 130 fourth-grade and 130 fifth-grade classrooms. The ITSS was designed to teach students how to select and encode strategic memory from expository texts. The system provides modelling, practice, assessment, scaffolding, and feedback to learners on identifying signalling words, summarizing, making inferences, generating elaborations, and monitoring comprehension. A large scale randomized controlled trial was conducted with 130 fourth-grade and 130 fifth-grade classrooms. Students completed GSRT- and researcher-designed measures of reading comprehension at pretest and posttests. An analysis of fourth-grade students using ITSS who scores less than the 25th percentile on the GSRT pretest showed small but meaningful effect sized on the posttests. The fifth-grade students in ITSS, who scored less than the 25% percentile on the GSRT pretest, showed the highest effect sizes (moderate to large effects) on the standardized test scores on the posttests.",2020,The effects of teaching the text structure strategy using a web-based Intelligent Tutoring System for the Text Structure Strategy (ITSS) were examined with fourth- and fifth-grade children scoring below the 25th percentile on comprehension measures using the Gray Silent Reading Test (GSRT) and researcher designed assessment from 130 fourth-grade and 130 fifth-grade classrooms.,['130 fourth-grade and 130 fifth-grade classrooms'],['ITSS'],[],"[{'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0205438', 'cui_str': 'Fourth (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205439', 'cui_str': 'Fifth (qualifier value)'}]",[],[],130.0,0.0278654,The effects of teaching the text structure strategy using a web-based Intelligent Tutoring System for the Text Structure Strategy (ITSS) were examined with fourth- and fifth-grade children scoring below the 25th percentile on comprehension measures using the Gray Silent Reading Test (GSRT) and researcher designed assessment from 130 fourth-grade and 130 fifth-grade classrooms.,"[{'ForeName': 'Kausalai', 'Initials': 'K', 'LastName': 'Wijekumar', 'Affiliation': 'Teaching, Learning and Culture, Texas A8M University, College Station, Texas.'}, {'ForeName': 'Bonnie J', 'Initials': 'BJ', 'LastName': 'Meyer', 'Affiliation': 'Educational Psychology, The Pennsylvania State University, University Park, Pennsylvania.'}, {'ForeName': 'Puiwa', 'Initials': 'P', 'LastName': 'Lei', 'Affiliation': 'Educational Psychology, The Pennsylvania State University, University Park, Pennsylvania.'}, {'ForeName': 'Andrea Lynn', 'Initials': 'AL', 'LastName': 'Beerwinkle', 'Affiliation': 'Teaching, Learning and Culture, Texas A8M University, College Station, Texas.'}, {'ForeName': 'Malatesha', 'Initials': 'M', 'LastName': 'Joshi', 'Affiliation': 'Teaching, Learning and Culture, Texas A8M University, College Station, Texas.'}]","Dyslexia (Chichester, England)",['10.1002/dys.1634']
930,31524141,Comparison of clinical outcomes of ultrasonography-guided and blind local injections in facet syndrome: A 6-week randomized controlled trial.,"BACKGROUND


Facet syndrome is defined as pain that arises from any structure of the facet joints, including the fibrous capsule, synovial membrane, hyaline cartilage, and bone.
OBJECTIVES


To compare the effectiveness of US-guided and blind injections on clinical outcome in facet syndrome.
MATERIALS AND METHODS


Forty-seven patients with the diagnosis of facet syndrome were included. Patients were consecutively randomized into one of the two groups. The patient's history, physical examination and routine laboratory parameters were obtained and diagnose was established based on physical findings. Two injections (mixture of 2 ml of 1% lidocaine hydrochloride and 20 mg of triamcinolone, to a single or maximum two sites depending on the clinical characteristics of the facet joint) were performed with 15 days apart, as blinded or US-guided manner. Clinical outcome assessments were carried out at 0, 2nd and 6th weeks, using Visual Analog Scale (VAS), Oswestry Disability Index (ODI) and State-Trait Anxiety Inventory (STAI).
RESULTS


The patients' initial VAS and ODI were not significantly different. When the two groups were compared in the 6th week in terms of VAS scores, improvement was more pronounced in the US-guided injection group (US-guided group (n= 23) before 7.6 (2.2) cm, after 3.0 (1.7) cm, P= 0.0001 vs blind group (n= 24) before 7.2 (1.3) cm, after 5.2 (2.0) cm, P= 0.0001). The improvement in initial and 6th week ODI was statistically significant in the US-guided injection group (P= 0.006). Except STAI I for US-group, trait anxiety scale scores were significant in both groups.
CONCLUSION


The US-guided local injections offer better clinical outcome in the treatment of facet syndrome.",2020,The improvement in initial and 6th week ODI was statistically significant in the US-guided injection group (P= 0.006).,"['Forty-seven patients with the diagnosis of facet syndrome were included', 'facet syndrome']","['ultrasonography-guided and blind local injections', 'US-guided and blind injections', 'Two injections (mixture of 2\xa0ml of 1% lidocaine hydrochloride and 20\xa0mg of triamcinolone']","['Visual Analog Scale (VAS), Oswestry Disability Index (ODI) and State-Trait Anxiety Inventory (STAI', 'initial VAS and ODI', 'VAS scores', 'trait anxiety scale scores']","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0222679', 'cui_str': 'Structure of articular surface of bone'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0041618', 'cui_str': 'Echotomography'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0439962', 'cui_str': 'Mixture (qualifier value)'}, {'cui': 'C0546869', 'cui_str': 'Lidocaine Hydrochloride'}, {'cui': 'C0040864', 'cui_str': 'Triamcinolone'}]","[{'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index (assessment scale)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0222045'}]",47.0,0.0356601,The improvement in initial and 6th week ODI was statistically significant in the US-guided injection group (P= 0.006).,"[{'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Karkucak', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Medical School, Division of Rheumatology, Karadeniz Technical University, Farabi Hospital, Trabzon, Turkey.'}, {'ForeName': 'İbrahim', 'Initials': 'İ', 'LastName': 'Batmaz', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Medical School, Dicle University, Diyarbakır, Turkey.'}, {'ForeName': 'Servet', 'Initials': 'S', 'LastName': 'Kerimoglu', 'Affiliation': 'Department Orthopaedics and Traumatology, Medical School, Karadeniz Technical University, Trabzon, Turkey.'}, {'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Ayar', 'Affiliation': 'Department Physiology, Medical School, Karadeniz Techical University, Trabzon, Turkey.'}]",Journal of back and musculoskeletal rehabilitation,['10.3233/BMR-181447']
931,32003285,Validation of a Self-Fitting Method for Over-the-Counter Hearing Aids.,"In common practice, hearing aids are fitted by a clinician who measures an audiogram and uses it to generate prescriptive gain and output targets. This report describes an alternative method where users select their own signal processing parameters using an interface consisting of two wheels that optimally map to simultaneous control of gain and compression in each frequency band. The real-world performance of this approach was evaluated via a take-home field trial. Participants with hearing loss were fitted using clinical best practices (audiogram, fit to target, real-ear verification, and subsequent fine tuning). Then, in their everyday lives over the course of a month, participants either selected their own parameters using this new interface (Self group; n = 38) or used the parameters selected by the clinician with limited control (Audiologist Best Practices Group; n = 37). On average, the gain selected by the Self group was within 1.8 dB overall and 5.6 dB per band of that selected by the audiologist. Participants in the Self group reported better sound quality than did those in the Audiologist Best Practices group. In blind sound quality comparisons conducted in the field, participants in the Self group slightly preferred the parameters they selected over those selected by the clinician. Finally, there were no differences between groups in terms of standard clinical measures of hearing aid benefit or speech perception in noise. Overall, the results indicate that it is possible for users to select effective amplification parameters by themselves using a simple interface that maps to key hearing aid signal processing parameters.",2020,"Finally, there were no differences between groups in terms of standard clinical measures of hearing aid benefit or speech perception in noise.",['Participants with hearing loss'],[],"['sound quality', 'standard clinical measures of hearing aid benefit or speech perception in noise']",[],[],"[{'cui': 'C1293120', 'cui_str': 'Sounding'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0018768', 'cui_str': 'Hearing Aids'}, {'cui': 'C0037826', 'cui_str': 'Speech Perception'}, {'cui': 'C0028263', 'cui_str': 'Noise'}]",,0.0153411,"Finally, there were no differences between groups in terms of standard clinical measures of hearing aid benefit or speech perception in noise.","[{'ForeName': 'Andrew T', 'Initials': 'AT', 'LastName': 'Sabin', 'Affiliation': 'Bose Corporation, Framingham, MA, USA.'}, {'ForeName': 'Dianne J', 'Initials': 'DJ', 'LastName': 'Van Tasell', 'Affiliation': 'Bose Corporation, Framingham, MA, USA.'}, {'ForeName': 'Bill', 'Initials': 'B', 'LastName': 'Rabinowitz', 'Affiliation': 'Bose Corporation, Framingham, MA, USA.'}, {'ForeName': 'Sumitrajit', 'Initials': 'S', 'LastName': 'Dhar', 'Affiliation': 'Roxelyn and Richard Pepper Department of Communication Sciences and Disorders, Northwestern University, Evanston, IL, USA.'}]",Trends in hearing,['10.1177/2331216519900589']
932,32060584,[Positron emission tomography-guided treatment in early-stage favorable Hodgkin lymphoma: final results of the international randomized phase III HD16 trial conducted by the German Hodgkin Study Group].,,2020,,['early-stage favorable Hodgkin lymphoma'],['Positron emission tomography-guided treatment'],[],"[{'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C1266193', 'cui_str': 'Hodgkin lymphoma - category (morphologic abnormality)'}]","[{'cui': 'C0032743', 'cui_str': 'Positron-Emission Tomography'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",[],,0.0249972,,"[{'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Nieder', 'Affiliation': 'Dept. of Oncology and Palliative Medicine, Nordland Hospital Trust, P.O. Box 1480, 8092, Bodø, Norwegen. cnied@hotmail.com.'}]",Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al],['10.1007/s00066-020-01593-0']
933,31188172,Comparing Postoperative Analgesic Effect of Dexmedetomidine or Dexamethasone Added to Lidocaine Through Infraclavicular Block in Forearm Surgery.,"OBJECTIVE


The objective of this study was to compare the analgesic efficacy of dexamethasone versus dexmedetomidine added to lidocaine using infraclavicular block in patients undergoing forearm fracture surgery.
METHOD


Seventy-five patients aged 20 to 60 years were recruited for a prospective, double-blinded, randomized clinical trial. Ultrasound-guided infraclavicular brachial plexus block was performed in 3 groups by injecting 28 mL lidocaine plus 2 mL distilled water (Lido), 28 mL lidocaine plus 2 mL (8 mg) dexamethasone (Dexa), and 28 mL lidocaine plus 2 mL (1 µg/kg) dexmedetomidine (Dexm). Sensory and motor block onset time and the duration, hemodynamic variables, the time for the first analgesic request, and the total analgesic agents consumed within 6 hours after infraclavicular block were assessed.
RESULTS


Sensory block duration in the Dexm group was significantly greater than in the Lido (P=0.019) and Dexa (P=0.046) groups. The mean motor block duration in the Dexm group showed to be significantly longer than that in the Lido group (P=0.009). Pain intensity within 4 hours after block significantly increased in the Lido group compared with that in the Dexa and Dexm groups (P=0.001). Analgesic consumption during 6 hours after the procedure was higher in the Lido group when compared with the other 2 groups (P=0.001). The Dexm group showed the highest reduction in the mean arterial pressure (P=0.006) and heart rate (P=0.001) among the 3 groups.
CONCLUSIONS


There was no significant difference in postoperative pain intensity between the Dexa and Dexm groups, although DEXm demonstrated a longer sensory block duration in comparison with dexamethasone as a lidocaine adjuvant in infraclavicular block.",2019,"The dexamedetomidine group showed the highest reduction in the mean arterial pressure (P=0.006) and heart rate (P=0.001) between the three groups.
","['patients undergoing forearm fracture surgery', 'Forearm Surgery', 'Seventy-five patients 20-60 years old']","['Lidocaine', 'mL', 'lidocaine', 'mL lidocaine plus2▒mL distilled water (Lido), 28▒mL lidocaine plus2▒mL (8▒mg) dexamethasone (Dexa), and 28▒mL lidocaineplus2▒', 'Ultrasound-guided infraclavicular brachial plexus block', 'dexamedetomidine', 'dexmedetomidine', 'dexamethasone', 'Dexmedetomidine or Dexamethasone']","['analgesic efficacy', 'mean motor block duration', 'heart rate', 'Pain intensity', 'Analgesic consumption', 'postoperative pain intensity', 'Dexm).Sensory and motor block onset time and the duration, hemodynamic variables, the time for the first analgesic request, and the total analgesic agents', 'Sensory block duration', 'sensory block duration', 'mean arterial pressure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1305215', 'cui_str': 'Fracture of forearm (disorder)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0016536', 'cui_str': 'Antebrachiums'}, {'cui': 'C4319621', 'cui_str': 'Seventy-five'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0394700', 'cui_str': 'Brachial plexus block by infraclavicular approach (procedure)'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}]","[{'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0420259', 'cui_str': 'Analgesics requested (finding)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}]",75.0,0.133958,"The dexamedetomidine group showed the highest reduction in the mean arterial pressure (P=0.006) and heart rate (P=0.001) between the three groups.
","[{'ForeName': 'Siamak', 'Initials': 'S', 'LastName': 'Yaghoobi', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Qazvin University of Medical Sciences, Qazvin, Iran.'}, {'ForeName': 'Hoda', 'Initials': 'H', 'LastName': 'Shahamat', 'Affiliation': ''}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Alizadeh', 'Affiliation': ''}, {'ForeName': 'Marzieh Beigom', 'Initials': 'MB', 'LastName': 'Khezri', 'Affiliation': ''}]",The Clinical journal of pain,['10.1097/AJP.0000000000000736']
934,30946523,"Long-term androgen deprivation, with or without radiotherapy, in locally advanced prostate cancer: updated results from a phase III randomised trial.","OBJECTIVES


To report the long-term oncological outcomes of a randomised trial comparing androgen-deprivation therapy (ADT) combined with external beam radiation therapy (EBRT) and ADT alone in patients with locally advanced prostate cancer.
PATIENTS AND METHODS


In this multicentre phase III trial, patients were randomly assigned to ADT alone or ADT+EBRT. Leuprorelin 11.25 mg was administered for 3 years. The whole pelvis was treated at a dose of 46 Gy and the prostate with a boost from 20 to 28 Gy. The primary endpoint was progression-free survival (PFS). Secondary endpoints included overall survival (OS), disease-specific survival (DSS), locoregional PFS (LRPFS), metastasis-free survival (MFS), biochemical PFS (BPFS), and tolerance.
RESULTS


With a median follow-up of 7.3 years, 263 patients were included. The 8-year PFS rate was significantly higher in the ADT+EBRT arm than in the ADT arm (48% vs 7%; hazard ratio [HR] 0.27, 95% confidence interval [CI] 0.17-0.39; P < 0.001); in patients with a baseline PSA level ≥50 ng/mL (HR 0.10, 95% CI 0.05-0.20; P < 0.001) and in patients with a baseline PSA level <50 ng/mL (HR 0.28, 95% CI 0.19-0.40; P < 0.001). The risk of death from prostate cancer was significantly reduced in the ADT+EBRT arm (sub-HR [SHR] 0.48, 95% CI 0.25-0.91; P = 0.02). The 8-year OS rate was 57% in the ADT arm and 65% in the ADT+EBRT arm (no significant difference). LRPFS was significantly in favour of the ADT+EBRT arm (SHR 0.61, 95% CI 0.42-0.89; P = 0.01). MFS was comparable between both arms (P = 0.88). Analysis of toxicities revealed acute lower tolerance in the ADT+EBRT arm, with a gradual decrease in intensity from 6 months after the end of EBRT.
CONCLUSIONS


These long-term results confirm the oncological benefit of combining EBRT with ADT in the treatment of locally advanced prostate cancer.",2020,"The 8-year PFS rate was significantly higher in the ADT+EBRT arm than in the ADT arm (48% versus 7%; hazard ratio: 0.27; 95%CI: (0.17;0.39), p<0.0001) (hazard ratio [HR] = 0.10; 95%CI: (0.05; 0.20); p < 0.0001 in patients with baseline PSA ≥ 50ng/ml and HR = 0.28; 95%CI: (0.19; 0.40), p < 0.0001 in patients with baseline PSA < 50ng/ml).","['locally advanced prostate cancer', 'locally-advanced prostate cancer', 'With a median follow-up of 7.3 years, 263 patients were included', 'patients treated with locally advanced prostate cancer']","['Leuprorelin', 'Long-term androgen deprivation, with or without radiotherapy', 'ADT alone or ADT+EBRT', 'EBRT with ADT', 'androgen-deprivation therapy (ADT) combined with external beam radiation therapy (EBRT) and ADT alone']","['progression-free survival (PFS', 'overall survival (OS), disease-specific survival (DSS), locoregional progression free survival (LPFS), metastasis-free survival (MFS), biochemical progression free survival (BPFS) and tolerance', 'MFS', '8-year PFS rate', '8-year OS rate', 'risk of death from prostate cancer', 'LPFS']","[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517671', 'cui_str': '263'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0085272', 'cui_str': 'Leuprolide'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0002844', 'cui_str': 'Androgenic Compounds'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy (procedure)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0034619', 'cui_str': 'radiation therapy'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}]",263.0,0.383482,"The 8-year PFS rate was significantly higher in the ADT+EBRT arm than in the ADT arm (48% versus 7%; hazard ratio: 0.27; 95%CI: (0.17;0.39), p<0.0001) (hazard ratio [HR] = 0.10; 95%CI: (0.05; 0.20); p < 0.0001 in patients with baseline PSA ≥ 50ng/ml and HR = 0.28; 95%CI: (0.19; 0.40), p < 0.0001 in patients with baseline PSA < 50ng/ml).","[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Sargos', 'Affiliation': 'Department of Radiation Oncology, Institut Bergonié, Bordeaux, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Mottet', 'Affiliation': 'Department of Urology, University Hospital, Saint-Etienne, France.'}, {'ForeName': 'Carine', 'Initials': 'C', 'LastName': 'Bellera', 'Affiliation': 'Clinical and Epidemiological Research Unit, Institut Bergonié, Bordeaux, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Richaud', 'Affiliation': 'Department of Radiation Oncology, Institut Bergonié, Bordeaux, France.'}]",BJU international,['10.1111/bju.14768']
935,21221666,Assessment of adjacent-segment mobility after cervical disc replacement versus fusion: RCT with 1 year's results.,"Disc prostheses have been designed to restore and maintain cervical segmental motion and reduce the accelerated degeneration of the adjacent level. There is no knowledge about the reaction of the neighboured asymptomatic segments after implantation of prostheses or fusion. The effects of these procedures to segmental movement of the uninvolved vertebrae have not been subjected to studies so far. The objective of this study was to compare the segmental motion following cervical disc replacement versus fusion and the correlation to the clinical outcome. Another aim was to compare the segmental motion of the asymptomatic segments above the treated ones and to compare both with Roentgen stereometric analysis (RSA) including the asymptomatic segments. 20 patients with one-level cervical radiculopathy scheduled for surgery were randomized to arthroplasty (10 patients, study group) or anterior cervical discectomy and fusion (10 patients, control group). Clinical results were evaluated using Visual Analogue Scale and Neck Disability Index. RSA was performed immediately postoperative, after 6 and 12 months. The adjacent segment showed a significantly higher segmental motion in all three-dimensional axes in comparison to the segment treated with prostheses (P < 0.05). In the fusion group the segmental motion of the adjacent segment was significantly higher in all three-dimensional axes (P < 0.05) at each examination time. When the adjacent level of both groups is compared, the fusion group could show a higher segmental motion in all three-dimensional axes, but without significant difference (P > 0.05) 1 year after surgery. Regarding the clinical results, there was no significant difference in pain relief between both groups (P > 0.05). In conclusion, the adjacent segment could show a higher segmental motion, when compared with the segment either treated with prostheses or fusion. There was no significant difference in segmental motion adjacent to prosthesis or fusion. Clinical results did also show no significant difference in pain relief between both groups.",2011,The adjacent segment showed a significantly higher segmental motion in all three-dimensional axes in comparison to the segment treated with prostheses (P < 0.05).,['20 patients with one-level cervical radiculopathy scheduled for surgery'],"['RSA', 'cervical disc replacement versus fusion: RCT', 'Roentgen stereometric analysis (RSA', 'anterior cervical discectomy and fusion']","['Visual Analogue Scale and Neck Disability Index', 'segmental motion', 'segmental motion of the adjacent segment', 'segmental motion adjacent to prosthesis or fusion', 'pain relief']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0742186', 'cui_str': 'Radiculopathy, Cervical'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C1705370', 'cui_str': 'Disc - unit of product usage'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C1293131', 'cui_str': 'Fusion procedure (procedure)'}, {'cui': 'C0560562', 'cui_str': 'roentgen (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0442011', 'cui_str': 'Anterior cervical spine approach (qualifier value)'}, {'cui': 'C0206078', 'cui_str': 'Diskectomy'}]","[{'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205122', 'cui_str': 'Segmental (qualifier value)'}, {'cui': 'C0687704', 'cui_str': 'Motions (qualifier value)'}, {'cui': 'C0205117', 'cui_str': 'Juxta-posed (qualifier value)'}, {'cui': 'C0441635', 'cui_str': 'Segment (qualifier value)'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}, {'cui': 'C1293131', 'cui_str': 'Fusion procedure (procedure)'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}]",20.0,0.0279182,The adjacent segment showed a significantly higher segmental motion in all three-dimensional axes in comparison to the segment treated with prostheses (P < 0.05).,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Nabhan', 'Affiliation': 'Department of Neurosurgery, Neurosurgical Department, University of Saarland, Homburg, Germany. dr_a_nabhan@hotmail.com'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Ishak', 'Affiliation': ''}, {'ForeName': 'W I', 'Initials': 'WI', 'LastName': 'Steudel', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Ramadhan', 'Affiliation': ''}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Steimer', 'Affiliation': ''}]","European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society",['10.1007/s00586-010-1588-2']
936,31531855,Impacts of early social experience on cognitive development in infant rhesus macaques.,"Although much is known about the influences of early life experiences on the neurobiology and behavior of macaque models of child development, there is scant literature on cognitive development with respect to early rearing. Here, we examined the effects of rearing condition on affective reactivity and cognitive development in infant rhesus macaques. Infants were pseudo-randomly assigned to one of the two rearing conditions: nursery reared (NR, N = 32; 16 peer-reared, 16 surrogate-peer-reared) or mother-peer-reared (MPR, N = 7). During the first month of life, infants were administered the Primate Neonatal Neurobehavioral Assessment (PNNA). Beginning at 4 months old, infants were tested on cognitive tasks that assessed reward association, cognitive flexibility, and impulsivity. We found no gross cognitive differences between MPR and NR infants. However, MPR infants were more reactive than NR infants on the PNNA. Additionally, reactivity on the PNNA correlated with impulsivity, such that infants who were more reactive at 1 month of age completed fewer trials correctly on this task at 8-10 months. These findings are the first to directly compare cognitive development in MPR and NR infants, and add to the existing literature elucidating the influences of early social experience on temperament and development.",2020,"Beginning at 4 months old, infants were tested on cognitive tasks that assessed reward association, cognitive flexibility, and impulsivity.","['infant rhesus macaques', 'Infants were pseudo-randomly assigned to one of the two rearing conditions: nursery reared (NR, N\xa0=\xa032; 16 peer-reared, 16 surrogate-peer-reared) or mother-peer-reared (MPR, N\xa0=\xa07']",['rearing condition'],"['cognitive tasks that assessed reward association, cognitive flexibility, and impulsivity', 'affective reactivity and cognitive development']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0024400', 'cui_str': 'Rhesus Macaque'}, {'cui': 'C0205237', 'cui_str': 'False (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0028659', 'cui_str': 'Nurseries'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C1701620', 'cui_str': 'mercaptopropionyl-phenylalanyl-cyclohexylalanyl-cyclohexylalanyl-arginyl-lysyl-prolyl-asparaginyl-aspartyl-lysinamide'}]","[{'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0021125', 'cui_str': 'Impulsivity'}, {'cui': 'C0243107', 'cui_str': 'development'}]",16.0,0.0111996,"Beginning at 4 months old, infants were tested on cognitive tasks that assessed reward association, cognitive flexibility, and impulsivity.","[{'ForeName': 'Ashley M', 'Initials': 'AM', 'LastName': 'Murphy', 'Affiliation': 'Neuroscience and Behavior, California National Primate Research Center, Davis, CA, USA.'}, {'ForeName': 'Amanda M', 'Initials': 'AM', 'LastName': 'Dettmer', 'Affiliation': 'Eunice Kennedy Shriver National Institute of Child Health & Human Development, National Institutes of Health, Poolesville, MD, USA.'}]",Developmental psychobiology,['10.1002/dev.21916']
937,20495932,Inclusion of the fracture level in short segment fixation of thoracolumbar fractures.,"Short segment posterior fixation is the preferred method for stabilizing thoracolumbar fractures. In case of significant disruption of the anterior column, the simple short segment construct does not ensure adequate stability. In this study, we tried to evaluate the effect of inclusion of the fractured vertebra in short segment fixation of thoracolumbar fractures. In a prospective randomized study, eighty patients with thoracolumbar fractures treated just with posterior pedicular fixation were randomized into two groups receiving either the one level above and one level below excluding the fracture level (bridging group), or including the fracture level (including group). Different clinical and radiological parameters were recorded and followed. A sum of 80 patients (42 patients in group 1 and 38 patients in group 2) were enrolled in the study. The patients in both the groups showed similar clinical outcome. There was a high rate of instrumentation failure in the ""bridging"" group. The ""bridging"" group showed a mean worsening (29%) in kyphosis, whereas the ""including"" group improved significantly by a mean of 6%. The significant effect of the ""including"" technique on the reduction of kyphotic deformity was most prominent in type C fractures. In conclusion, inclusion of the fracture level into the construct offers a better kyphosis correction, in addition to fewer instrument failures, without additional complications, and with a comparable-if not better-clinical and functional outcome. We recommend insertion of screws into pedicles of the fractured thoracolumbar vertebra when considering a short segment posterior fixation, especially in Magerl type C fractures.",2010,"The significant effect of the ""including"" technique on the reduction of kyphotic deformity was most prominent in type C fractures.","['eighty patients with thoracolumbar fractures treated just with posterior pedicular fixation', '80 patients (42 patients in group 1 and 38 patients in group 2) were enrolled in the study']",[],"['kyphotic deformity', 'rate of instrumentation failure']","[{'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0450219', 'cui_str': 'Thoracolumbar (qualifier value)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]",[],"[{'cui': 'C0000768', 'cui_str': 'Birth Defects'}, {'cui': 'C0021632', 'cui_str': 'instrumentation'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}]",80.0,0.0232848,"The significant effect of the ""including"" technique on the reduction of kyphotic deformity was most prominent in type C fractures.","[{'ForeName': 'Majid-Reza', 'Initials': 'MR', 'LastName': 'Farrokhi', 'Affiliation': 'Department of Neurosurgery, Shiraz University of Medical Sciences, Shiraz Neurosciences Research Center, PO Box 71455-166, Shiraz, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Razmkon', 'Affiliation': ''}, {'ForeName': 'Zohreh', 'Initials': 'Z', 'LastName': 'Maghami', 'Affiliation': ''}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Nikoo', 'Affiliation': ''}]","European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society",['10.1007/s00586-010-1449-z']
938,19763634,"Clinical and radiological evaluation of Trabecular Metal and the Smith-Robinson technique in anterior cervical fusion for degenerative disease: a prospective, randomized, controlled study with 2-year follow-up.","A prospective, randomized, controlled study was carried out to compare the radiological and clinical outcomes after anterior cervical decompression and fusion (ACDF) with Trabecular Metal (TM) to the traditional Smith-Robinson (SR) procedure with autograft. The clinical results of cervical fusion with autograft from the iliac crest are typically satisfactory, but implications from the donor site are frequently reported. Alternative materials for cervical body interfusion have shown lower fusion rates. Trabecular Metal is a porous tantalum biomaterial with structure and mechanical properties similar to that of trabecular bone and with proven osteoconductivity. As much as 80 consecutive patients planned for ACDF were randomized for fusion with either TM or tricortical autograft from the iliac crest (SR) after discectomy and decompression. Digitized plain radiographic images of 78 (98%) patients were obtained preoperatively and at 2-year follow-up and were subsequently evaluated by two senior radiologists. Fusion/non-fusion was classified by visual evaluation of the A-P and lateral views in forced flexion/extension of the cervical spine and by measuring the mobility between the fused vertebrae. MRI of 20 TM cases at 2 years was successfully used to assess the decompression of the neural structures, but was not helpful in determining fusion/non-fusion. Pain intensity in the neck, arms and pelvis/hip were rated by patients on a visual analog scale (VAS) and neck function was rated using the Neck Disability Index (NDI) the day before surgery and 4, 12 and 24 months postoperatively. Follow-ups at 12 and 24 months were performed by an unbiased observer, when patients also assessed their global outcome. Fusion rate in the SR group was 92%, and in the TM group 69% (P < 0.05). The accuracy of the measurements was calculated to be 2.4 degrees . Operating time was shorter for fusion with TM compared with autograft; mean times were 100 min (SD 18) and 123 min (SD 23), respectively (P = 0.001). The patients' global assessments of their neck and arm symptoms 2 years postoperatively for the TM group were rated as 79% much better or better after fusion with TM and 75% using autograft. Pain scores and NDI scores were significantly improved in both groups when compared with baseline at all follow-ups, except for neck pain at 1 year for the TM group. There was no statistically significant difference in clinical outcomes between fusion techniques or between patients who appeared radiologically fused or non-fused. There was no difference in pelvic/hip pain between patients operated on with or without autograft. In our study, Trabecular Metal showed a lower fusion rate than the Smith-Robinson technique with autograft after single-level anterior cervical fusion without plating. There was no difference in clinical outcomes between the groups. The operative time was shorter with Trabecular Metal implants.",2010,"Pain scores and NDI scores were significantly improved in both groups when compared with baseline at all follow-ups, except for neck pain at 1 year for the TM group.","['anterior cervical fusion for degenerative disease', '80 consecutive patients planned for ACDF']","['Trabecular Metal and the Smith-Robinson technique', 'TM or tricortical autograft', 'anterior cervical decompression and fusion (ACDF) with Trabecular Metal (TM) to the traditional Smith-Robinson (SR) procedure with autograft']","['Pain intensity', 'visual analog scale (VAS) and neck function', 'pelvic/hip pain', 'lower fusion rate', 'Fusion rate', 'neck pain', 'operative time', 'Pain scores and NDI scores', 'Operating time', 'clinical outcomes']","[{'cui': 'C0442011', 'cui_str': 'Anterior cervical spine approach (qualifier value)'}, {'cui': 'C1293131', 'cui_str': 'Fusion procedure (procedure)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C4552416', 'cui_str': 'Anterior cervical discectomy with fusion'}]","[{'cui': 'C1289927', 'cui_str': 'Metal (material)'}, {'cui': 'C0554249', 'cui_str': 'Smith (occupation)'}, {'cui': 'C0443050', 'cui_str': 'Robinson (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0040736', 'cui_str': 'Autotransplantation'}, {'cui': 'C0442011', 'cui_str': 'Anterior cervical spine approach (qualifier value)'}, {'cui': 'C1829459', 'cui_str': 'Decompression (procedure)'}, {'cui': 'C1293131', 'cui_str': 'Fusion procedure (procedure)'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0030797', 'cui_str': 'Pelvic Region'}, {'cui': 'C0019559', 'cui_str': 'Hip pain (finding)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1293131', 'cui_str': 'Fusion procedure (procedure)'}, {'cui': 'C0007859', 'cui_str': 'Neck Ache'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]",,0.034936,"Pain scores and NDI scores were significantly improved in both groups when compared with baseline at all follow-ups, except for neck pain at 1 year for the TM group.","[{'ForeName': 'Håkan', 'Initials': 'H', 'LastName': 'Löfgren', 'Affiliation': 'Neuro-Orthopedic Center, Ryhov Hospital, 55185 Jönköping, Sweden. Hakan.Lofgren@lj.se'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Engquist', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Hoffmann', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Sigstedt', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Vavruch', 'Affiliation': ''}]","European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society",['10.1007/s00586-009-1161-z']
939,32128614,"Transcutaneous electrical nerve stimulation for advanced cancer pain inpatients in specialist palliative care-a blinded, randomized, sham-controlled pilot cross-over trial.","PURPOSE


Transcutaneous electrical nerve stimulation (TENS) is a treatment option for cancer pain, but the evidence is inconclusive. We aimed to evaluate the efficacy and safety of TENS.
METHODS


A blinded, randomized, sham-controlled pilot cross-over trial (NCT02655289) was conducted on an inpatient specialist palliative care ward. We included adult inpatients with cancer pain ≥ 3 on an 11-point numerical rating scale (NRS). Intensity-modulated high TENS (IMT) was compared with placebo TENS (PBT). Patients used both modes according to their preferred application scheme during 24 h with a 24-h washout phase. The primary outcome was change in average pain intensity on the NRS during the preceding 24 h. Responders were patients with at least a ""slight improvement.""
RESULTS


Of 632 patients screened, 25 were randomized (sequence IMT-PBT = 13 and PBT-IMT = 12). Finally, 11 patients in IMT-PBT and 9 in PBT-IMT completed the study (N = 20). The primary outcome did not differ between groups (IMT minus PBT: - 0.2, 95% confidence interval - 0.9 to 0.6). However, responder rates were higher in IMT (17/20 [85%] vs. 10/20 [50%], p = 0.0428). Two patients experienced an uncomfortable feeling caused by the current, one after IMT and one after PBT. Seven patients (35%) desired a TENS prescription. Women and patients with incident pain were most likely to benefit from TENS.
CONCLUSION


TENS was safe, but IMT was unlikely to offer more analgesic effects than PBT. Even though many patients desired a TENS prescription, 50% still reported at least ""slight pain relief"" from PBT. Differences for gender and incident pain aspects demand future trials.",2020,"The primary outcome did not differ between groups (IMT minus PBT: - 0.2, 95% confidence interval - 0.9 to 0.6).","['11 patients in IMT-PBT and 9 in PBT-IMT completed the study (N\u2009=\u200920', '632 patients screened, 25', 'advanced cancer pain inpatients in specialist palliative care', 'adult inpatients with cancer pain ≥\u20093 on an 11-point numerical rating scale (NRS', 'inpatient specialist palliative care ward', 'Women and patients with incident pain']","['Transcutaneous electrical nerve stimulation (TENS', 'placebo TENS (PBT', 'Intensity-modulated high TENS (IMT', 'TENS', 'Transcutaneous electrical nerve stimulation']","['average pain intensity', 'uncomfortable feeling', 'slight improvement', 'analgesic effects', 'responder rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C1273400', 'cui_str': 'Specialist palliative care'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0596240', 'cui_str': 'Tumor-Related Pain'}, {'cui': 'C0222045'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0040654', 'cui_str': 'Electric Stimulation, Transcutaneous'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0443264', 'cui_str': 'Modulated (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0014518', 'cui_str': ""Lyell's Syndrome""}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C2937276', 'cui_str': 'Slight (qualifier value)'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}]",25.0,0.274577,"The primary outcome did not differ between groups (IMT minus PBT: - 0.2, 95% confidence interval - 0.9 to 0.6).","[{'ForeName': 'Waldemar', 'Initials': 'W', 'LastName': 'Siemens', 'Affiliation': 'Clinic for Palliative Care, Medical Center, Faculty of Medicine, University of Freiburg, Robert-Koch-Str 3, 79106, Freiburg, Germany. waldemar.siemens@googlemail.com.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Boehlke', 'Affiliation': 'Clinic for Palliative Care, Medical Center, Faculty of Medicine, University of Freiburg, Robert-Koch-Str 3, 79106, Freiburg, Germany.'}, {'ForeName': 'Michael I', 'Initials': 'MI', 'LastName': 'Bennett', 'Affiliation': 'Academic Unit of Palliative Care, Leeds Institute of Health Sciences (LIHS), School of Medicine, University of Leeds, Leeds, UK.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Offner', 'Affiliation': 'Department of Anesthesiology and Critical Care, Medical Center, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Gerhild', 'Initials': 'G', 'LastName': 'Becker', 'Affiliation': 'Clinic for Palliative Care, Medical Center, Faculty of Medicine, University of Freiburg, Robert-Koch-Str 3, 79106, Freiburg, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Gaertner', 'Affiliation': 'Center for Palliative Care Hildegard, Basel, Switzerland.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-020-05370-8']
940,32044905,Lowering effects of fish oil supplementation on proinflammatory markers in hypertension: results from a randomized controlled trial.,"Reduced inflammation is one of the potential mechanisms underlying the cardioprotective efficacy of fish oil enriched with eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). Supplementation with fish oil has favorable effects on cardiometabolic profiles in Inner Mongolia patients with hypertension, but whether the cardiovascular benefits can be ascribed to reduced subclinical inflammation is unclear among this population. Seventy-seven middle-aged/elderly hypertensive volunteers were randomly assigned to receive either fish oil (FO, n = 38, 2 g day-1 EPA + DHA) or control corn oil (CO, n = 39) for 90 days. FA compositions in erythrocytes and C-reactive protein (CRP, mg L-1), interleukin-6 (IL-6, pg mL-1) and tumor necrosis factor-α (TNF-α, pg mL-1) concentrations in the plasma were measured before and after the 90-day supplementation, and the cardiometabolic risk was expressed as continuously distributed z-scores calculated by standardizing and then summing the individual cardiovascular risk factors. Significant reductions in the TNF-α (-1.87 ± 2.71 vs. -0.64 ± 2.62, p = 0.02) and CRP levels (-0.85 ± 2.49 vs. 0.56 ± 2.14, p = 0.01) were found in the FO group compared with the CO group, but not in the IL-6 levels (-0.66 ± 1.05 vs. -0.25 ± 0.94, p = 0.10). The decreases in the changes of TNF-α levels were positively correlated with the reductions in the cardiometabolic risk scores in the subjects supplemented with FO (r = 0.35, p = 0.02), but not in the control subjects supplemented with CO (r = 0.09, p = 0.54). FO supplementation increased the levels of EPA (p = 0.013), DHA (p = 0.040) and total n-3 FA (p = 0.035), and decreased the levels of 20:4n-6 (p = 0.041) and total n-6 FA (p = 0.011) and the ratio of n-6 to n-3 FA (p = 0.001), compared with the changes related to the CO group. The increases in the changes of erythrocyte total n-3 FA levels were inversely correlated with the concentrations of TNF-α (r = -0.34, p = 0.001) and CRP (r = -0.29, p = 0.020). The present findings suggest that fish oil supplementation may attenuate the proinflammatory reactions in hypertension, which might help promote the cardiometabolic benefits in this Inner Mongolia population.",2020,"FO supplementation increased the levels of EPA (p = 0.013), DHA (p = 0.040) and total n-3 FA (p = 0.035), and decreased the levels of 20:4n-6 (p = 0.041) and total n-6 FA (p = 0.011) and the ratio of n-6 to n-3 FA (p = 0.001), compared with the changes related to the CO group.","['hypertension', 'Seventy-seven middle-aged/elderly hypertensive volunteers', 'Inner Mongolia patients with hypertension']","['FO supplementation', 'fish oil supplementation', 'eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA', 'Supplementation with fish oil', 'fish oil (FO, n = 38, 2 g day-1 EPA + DHA) or control corn oil']","['FA compositions in erythrocytes and C-reactive protein (CRP, mg L-1), interleukin-6 (IL-6, pg mL-1) and tumor necrosis factor-α (TNF-α, pg mL-1) concentrations', 'CRP levels', 'changes of TNF-α levels', 'total n-6 FA', 'cardiometabolic risk', 'cardiometabolic risk scores', 'CRP', 'IL-6 levels', 'cardiometabolic profiles', 'ratio of n-6 to n-3 FA', 'proinflammatory markers', 'erythrocyte total n-3 FA levels', 'levels of EPA', 'total n-3 FA']","[{'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0021515', 'cui_str': 'Inner Mongolia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic Acid'}, {'cui': 'C0556150', 'cui_str': 'docosahexaenoic acid'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0059057', 'cui_str': 'EPA (prealbumin)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0010029', 'cui_str': 'Corn Oil'}]","[{'cui': 'C0014792', 'cui_str': 'Blood Corpuscles, Red'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0673362', 'cui_str': 'L-1 (ester)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'Tumor Necrosis Factors'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0059057', 'cui_str': 'EPA (prealbumin)'}]",,0.0982996,"FO supplementation increased the levels of EPA (p = 0.013), DHA (p = 0.040) and total n-3 FA (p = 0.035), and decreased the levels of 20:4n-6 (p = 0.041) and total n-6 FA (p = 0.011) and the ratio of n-6 to n-3 FA (p = 0.001), compared with the changes related to the CO group.","[{'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Yang', 'Affiliation': 'Institute of Lipids Medicine & School of Public Health and Management, Wenzhou Medical University, Wenzhou, China. yb@wmu.edu.cn.'}, {'ForeName': 'Xiao-Li', 'Initials': 'XL', 'LastName': 'Ren', 'Affiliation': 'Institute of Lipids Medicine & School of Public Health and Management, Wenzhou Medical University, Wenzhou, China. yb@wmu.edu.cn.'}, {'ForeName': 'Zi-Hao', 'Initials': 'ZH', 'LastName': 'Li', 'Affiliation': 'Institute of Nutrition and Health, Qingdao University, Qingdao, China. duoli@qdu.edu.cn.'}, {'ForeName': 'Mei-Qi', 'Initials': 'MQ', 'LastName': 'Shi', 'Affiliation': 'Institute of Nutrition and Health, Qingdao University, Qingdao, China. duoli@qdu.edu.cn.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Ding', 'Affiliation': 'The Province Center for Cardio-Cerebral-Vascular Disease, Zhejiang Hospital, Hangzhou, China.'}, {'ForeName': 'Kuan-Pin', 'Initials': 'KP', 'LastName': 'Su', 'Affiliation': 'Department of Psychiatry & Mind-Body Interface Laboratory, China Medical University Hospital, Taichung, Taiwan.'}, {'ForeName': 'Xiao-Juan', 'Initials': 'XJ', 'LastName': 'Guo', 'Affiliation': 'Institute of Lipids Medicine & School of Public Health and Management, Wenzhou Medical University, Wenzhou, China. yb@wmu.edu.cn.'}, {'ForeName': 'Duo', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': 'Institute of Nutrition and Health, Qingdao University, Qingdao, China. duoli@qdu.edu.cn.'}]",Food & function,['10.1039/c9fo03085a']
941,31793165,"Effects of sequential treatment with lixisenatide, insulin glargine, or their combination on meal-related glycaemic excursions, insulin and glucagon secretion, and gastric emptying in patients with type 2 diabetes.","AIM


To examine the glucose-lowering mechanisms of the glucagon-like peptide-1 receptor agonist lixisenatide after two subsequent meals and in combination with basal insulin.
MATERIALS AND METHODS


Twenty-eight metformin-treated patients with type 2 diabetes were randomly assigned to treatment sequences with either lixisenatide or insulin glargine alone for 4 weeks, and a combination of both treatments for 4 weeks. Metabolic examinations were performed before and after each treatment period following breakfast and a late lunch 8 hours later.
RESULTS


Lixisenatide mainly reduced postprandial glycaemia, while insulin glargine mainly reduced fasting glucose after breakfast (P < 0.05). This was partially preserved after a late lunch (P < 0.05). After breakfast, lixisenatide reduced insulin secretion and glucagon levels significantly. These effects were lost after a late lunch. Insulin glargine did not significantly reduce glucagon or insulin secretion. Gastric emptying was slowed by lixisenatide, but not by insulin glargine after breakfast. After the late lunch, lixisenatide slightly accelerated gastric emptying.
CONCLUSIONS


Lixisenatide decelerates gastric emptying after breakfast, thereby reducing glycaemic excursions, insulin secretion and glucagon levels. The glycaemic reduction persists until after a late lunch, despite accelerated gastric emptying. The combination with insulin glargine enhances the glucose-lowering effect because of complementary modes of action.",2020,"Lixisenatide mainly reduced postprandial glycaemia, while insulin glargine mainly reduced fasting glucose after breakfast (p < 0.05).","['patients with type 2 diabetes', '28 metformin-treated patients with type 2 diabetes']","['lixisenatide, insulin glargine', 'Insulin glargine', 'insulin glargine', 'lixisenatide or insulin glargine alone']","['insulin secretion and glucagon levels', 'Gastric emptying', 'glycaemic excursions, insulin secretion and glucagon levels', 'postprandial glycaemia', 'Lixisenatide decelerates gastric emptying', 'fasting glucose', 'glucagon or insulin secretion', 'glycaemic excursions, insulin and glucagon secretion, and gastric emptying', 'gastric emptying']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C2973895', 'cui_str': 'Lixisenatide'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}]","[{'cui': 'C1256369', 'cui_str': 'Insulin Secretion'}, {'cui': 'C0337437', 'cui_str': 'Glucagon test (procedure)'}, {'cui': 'C0017127', 'cui_str': 'Gastric Emptyings'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C2973895', 'cui_str': 'Lixisenatide'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0876232', 'cui_str': 'glucagon recombinant'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0036537', 'cui_str': 'Secretions'}]",,0.024834,"Lixisenatide mainly reduced postprandial glycaemia, while insulin glargine mainly reduced fasting glucose after breakfast (p < 0.05).","[{'ForeName': 'Juris J', 'Initials': 'JJ', 'LastName': 'Meier', 'Affiliation': 'Diabetes Center Bochum-Hattingen, St. Josef-Hospital, Ruhr-University Bochum, Bochum, Germany.'}, {'ForeName': 'Björn A', 'Initials': 'BA', 'LastName': 'Menge', 'Affiliation': 'Diabetes Center Bochum-Hattingen, St. Josef-Hospital, Ruhr-University Bochum, Bochum, Germany.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Schenker', 'Affiliation': 'Diabetes Center Bochum-Hattingen, St. Josef-Hospital, Ruhr-University Bochum, Bochum, Germany.'}, {'ForeName': 'Silke', 'Initials': 'S', 'LastName': 'Erdmann', 'Affiliation': 'Diabetes Center Bochum-Hattingen, St. Josef-Hospital, Ruhr-University Bochum, Bochum, Germany.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Kahle-Stephan', 'Affiliation': 'Diabetes Center Bochum-Hattingen, St. Josef-Hospital, Ruhr-University Bochum, Bochum, Germany.'}, {'ForeName': 'Freimut', 'Initials': 'F', 'LastName': 'Schliess', 'Affiliation': 'Profil Institut für Stoffwechselforschung, Neuss, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Kapitza', 'Affiliation': 'Profil Institut für Stoffwechselforschung, Neuss, Germany.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Nauck', 'Affiliation': 'Diabetes Center Bochum-Hattingen, St. Josef-Hospital, Ruhr-University Bochum, Bochum, Germany.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13935']
942,31415908,GLP-1 receptor agonists do not affect sodium intake: Exploratory analyses from two randomized clinical trials.,"OBJECTIVES


Excessive sodium intake, despite current dietary advice, remains a global issue with cardiovascular and renal consequences. The aim of this study was to determine whether glucagon-like peptide receptor agonists (GLP-1 RAs), used as antihyperglycemic agents for type 2 diabetes (T2DM) management, may reduce salt cravings as they are known to reduce hedonic feeding behavior and are involved in sodium homeostasis by increasing renal sodium excretion.
METHODS


We performed exploratory analyses using data from two randomized, clinical crossover trials, which primarily aimed to assess the effects of GLP-1 RAs on central satiety and reward circuits and subsequent related feeding behavior. In study A, healthy, obese individuals and patients with T2DM were randomly assigned to receive intravenous administration of placebo or GLP-1 RA exenatide with or without concurrent GLP-1 receptor blockade, on separate testing days. In study B, individuals with T2DM randomly received GLP-1 RA liraglutide (titrated up to 1.8 mg daily) or titrated insulin glargine for 12 wk. In both studies, participants received an ad libitum mixed meal that served to calculate sodium intake. Moreover, salt craving was scored using a Likert scale.
RESULTS


In study A, acute exenatide, parallel to reduced total food intake, reduced sodium intake in all studied groups by up to 30%. In study B, prolonged liraglutide treatment did not affect sodium or total caloric intake. Neither acute exenatide nor prolonged liraglutide treatment affected salt craving as measured by the Likert scale.
CONCLUSION


Acute exenatide reduced sodium intake in light of a generalized reduction in food ingestion, while prolonged intervention with liraglutide did not lower sodium intake. Neither intervention affected salt craving. Given the known effects of these drugs on renal sodium excretion, blood pressure, and renal and cardiovascular outcome, it seems plausible to perform dedicated mechanistic studies in humans to assess the effects of GLP-1 RA administration on sodium balance.",2019,"In study A, acute exenatide, parallel to reduced total food intake, reduced sodium intake in all studied groups by up to 30%.","['healthy, obese individuals and patients with T2DM']","['placebo or GLP-1 RA exenatide with or without concurrent GLP-1 receptor blockade', 'glucagon-like peptide receptor agonists (GLP-1 RAs', 'liraglutide', 'GLP-1 RA liraglutide', 'GLP-1 RAs', 'GLP-1 RA', 'titrated insulin glargine']","['total food intake, reduced sodium intake', 'renal sodium excretion, blood pressure, and renal and cardiovascular outcome', 'central satiety and reward circuits and subsequent related feeding behavior', 'salt craving', 'sodium or total caloric intake']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C0167117', 'cui_str': 'exenatide'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0378073', 'cui_str': 'GLP-1 Receptor'}, {'cui': 'C3540676', 'cui_str': 'Blockade'}, {'cui': 'C4042844', 'cui_str': 'GLPR Proteins'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0036239', 'cui_str': 'Satiations'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0240928', 'cui_str': 'Salt craving'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}]",,0.0689192,"In study A, acute exenatide, parallel to reduced total food intake, reduced sodium intake in all studied groups by up to 30%.","[{'ForeName': 'Mark M', 'Initials': 'MM', 'LastName': 'Smits', 'Affiliation': 'Diabetes Center, Department of Internal Medicine, Amsterdam University Medical Center, Amsterdam, The Netherlands. Electronic address: Mm.smits1@vumc.nl.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Ten Kulve', 'Affiliation': 'Diabetes Center, Department of Internal Medicine, Amsterdam University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Liselotte', 'Initials': 'L', 'LastName': 'van Bloemendaal', 'Affiliation': 'Diabetes Center, Department of Internal Medicine, Amsterdam University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Lennart', 'Initials': 'L', 'LastName': 'Tonneijck', 'Affiliation': 'Diabetes Center, Department of Internal Medicine, Amsterdam University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Marcel H A', 'Initials': 'MHA', 'LastName': 'Muskiet', 'Affiliation': 'Diabetes Center, Department of Internal Medicine, Amsterdam University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Mark H H', 'Initials': 'MHH', 'LastName': 'Kramer', 'Affiliation': 'Diabetes Center, Department of Internal Medicine, Amsterdam University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Richard G', 'Initials': 'RG', 'LastName': 'Ijzerman', 'Affiliation': 'Diabetes Center, Department of Internal Medicine, Amsterdam University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Daniël H', 'Initials': 'DH', 'LastName': 'van Raalte', 'Affiliation': 'Diabetes Center, Department of Internal Medicine, Amsterdam University Medical Center, Amsterdam, The Netherlands.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2019.06.005']
943,32430373,Subjective Versus Objective Assessment of Cognitive Functioning in Primary Care.,"PURPOSE


This study examined the clinical utility of highly efficient subjective and objective screens of cognitive impairment.
METHOD


Participants ( N  = 124, age ≥ 65, mean = 73.59, SD = 6.26) completed a 2-item questionnaire of subjective memory functioning, a brief computerized cognitive test, and the Montreal Cognitive Assessment (MoCA). Next, participants were assigned to 1 of 4 conditions, based on their subjective (low/high) and objective (impaired/unimpaired) levels of cognitive functioning. Further analysis divided the sample into age-based groups (ie, age < 75, age ≥ 75).
RESULTS


The proportion of participants in the impaired subsample (ie, MoCA < 26), who reported a high level of subjective concern about their memory, was low (ie, 0.15). Among unimpaired participants, analysis detected significant group differences across subjective memory levels ( P  < .0003) and age ( P  < .005) categories on one of the three tasks of the computerized test (ie, cognitive control). In contrast, the MoCA offered no differentiation between these groups.
CONCLUSION


Screening protocols in which cognitive testing is administered subsequent to patient complaint are prone to underdiagnosis. In addition, common dementia screens are insensitive to subjective deficits and healthy cognitive aging. Therefore, they may lead to dismissing valid concerns that deserve preventive attention. Primary care needs efficient screening tools that are sensitive to prodromal decline.",2020,"Among unimpaired participants, analysis detected significant group differences across subjective memory levels ( P  < .0003) and age ( P  < .005) categories on one of the three tasks of the computerized test (ie, cognitive control).","['Participants ( N  = 124, age ≥ 65, mean = 73.59, SD = 6.26) completed a 2-item questionnaire of subjective memory functioning, a brief computerized cognitive test, and the Montreal Cognitive Assessment (MoCA', 'Further analysis divided the sample into age-based groups (ie, age < 75, age ≥ 75', 'Primary Care']",[],['subjective memory levels'],"[{'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0025750', 'cui_str': ""3,3'-Dichloro-4,4'-Diaminodiphenylmethane""}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]",[],"[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0209543,"Among unimpaired participants, analysis detected significant group differences across subjective memory levels ( P  < .0003) and age ( P  < .005) categories on one of the three tasks of the computerized test (ie, cognitive control).","[{'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Hess', 'Affiliation': 'From the Department of Counseling and School Psychology, University of Massachusetts, Boston, MA (CH, BL, JH, SG, AE, KF); Cleveland Clinic, Lerner College of Medicine, Ohio (AH); Tufts University School of Medicine, Boston, MA (DD); and McLean Hospital, Belmont, MA, Harvard Medical School (BL).'}, {'ForeName': 'Boaz', 'Initials': 'B', 'LastName': 'Levy', 'Affiliation': 'From the Department of Counseling and School Psychology, University of Massachusetts, Boston, MA (CH, BL, JH, SG, AE, KF); Cleveland Clinic, Lerner College of Medicine, Ohio (AH); Tufts University School of Medicine, Boston, MA (DD); and McLean Hospital, Belmont, MA, Harvard Medical School (BL). boaz.levy@umb.edu.'}, {'ForeName': 'Ardeshir Z', 'Initials': 'AZ', 'LastName': 'Hashmi', 'Affiliation': 'From the Department of Counseling and School Psychology, University of Massachusetts, Boston, MA (CH, BL, JH, SG, AE, KF); Cleveland Clinic, Lerner College of Medicine, Ohio (AH); Tufts University School of Medicine, Boston, MA (DD); and McLean Hospital, Belmont, MA, Harvard Medical School (BL).'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Hogan', 'Affiliation': 'From the Department of Counseling and School Psychology, University of Massachusetts, Boston, MA (CH, BL, JH, SG, AE, KF); Cleveland Clinic, Lerner College of Medicine, Ohio (AH); Tufts University School of Medicine, Boston, MA (DD); and McLean Hospital, Belmont, MA, Harvard Medical School (BL).'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Greenspan', 'Affiliation': 'From the Department of Counseling and School Psychology, University of Massachusetts, Boston, MA (CH, BL, JH, SG, AE, KF); Cleveland Clinic, Lerner College of Medicine, Ohio (AH); Tufts University School of Medicine, Boston, MA (DD); and McLean Hospital, Belmont, MA, Harvard Medical School (BL).'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Elber', 'Affiliation': 'From the Department of Counseling and School Psychology, University of Massachusetts, Boston, MA (CH, BL, JH, SG, AE, KF); Cleveland Clinic, Lerner College of Medicine, Ohio (AH); Tufts University School of Medicine, Boston, MA (DD); and McLean Hospital, Belmont, MA, Harvard Medical School (BL).'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Falcon', 'Affiliation': 'From the Department of Counseling and School Psychology, University of Massachusetts, Boston, MA (CH, BL, JH, SG, AE, KF); Cleveland Clinic, Lerner College of Medicine, Ohio (AH); Tufts University School of Medicine, Boston, MA (DD); and McLean Hospital, Belmont, MA, Harvard Medical School (BL).'}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'Driscoll', 'Affiliation': 'From the Department of Counseling and School Psychology, University of Massachusetts, Boston, MA (CH, BL, JH, SG, AE, KF); Cleveland Clinic, Lerner College of Medicine, Ohio (AH); Tufts University School of Medicine, Boston, MA (DD); and McLean Hospital, Belmont, MA, Harvard Medical School (BL).'}]",Journal of the American Board of Family Medicine : JABFM,['10.3122/jabfm.2020.03.190265']
944,20632044,"Dynamic stabilization adjacent to single-level fusion: part II. No clinical benefit for asymptomatic, initially degenerated adjacent segments after 6 years follow-up.","Progression of degeneration is often described in patients with initially degenerated segment adjacent to fusion (iASD) at the time of surgery. The aim of the present study was to compare dynamic fixation of a clinically asymptomatic iASD, with circumferential lumbar fusion alone. 60 patients with symptomatic degeneration of L5/S1 or L4/L5 (Modic ≥ 2°) and asymptomatic iASD (Modic = 1°, confirmed by discography) were divided into two groups. 30 patients were treated with circumferential single-level fusion (SLF). In dynamic fixation transition (DFT) patients, additional posterior dynamic fixation of iASD was performed. Preoperatively, at 12 months, and at a mean follow-up of 76.4 (60-91) months, radiological (MRI, X-ray) and clinical (ODI, VAS, satisfaction) evaluations assessed fusion, progression of adjacent segment degeneration (PASD), radiologically adverse events, functional outcome, and pain. At final follow-up, two non-fusions were observed in both groups. 6 SLF patients and 1 DFT patient presented a PASD. In two DFT patients, a PASD occurred in the segment superior to the dynamic fixation, and in one DFT patient, a fusion of the dynamically fixated segment was observed. 4 DFT patients presented radiological implant failure. While no differences in clinical scores were observed between groups, improvement from pre-operative conditions was significant (all p < 0.001). Clinical scores were equal in patients with PASD and/or radiologically adverse events. We do not recommend dynamically fixating the adjacent segment in patients with clinically asymptomatic iASD. The lower number of PASD with dynamic fixation was accompanied by a high number of implant failures and a shift of PASD to the superior segment.",2010,"While no differences in clinical scores were observed between groups, improvement from pre-operative conditions was significant (all p < 0.001).","['30 patients were treated with', 'patients with initially degenerated segment adjacent to fusion (iASD) at the time of surgery', 'patients with clinically asymptomatic iASD', '60 patients with symptomatic degeneration of L5/S1 or L4/L5 (Modic ≥ 2°) and asymptomatic iASD (Modic = 1°, confirmed by discography']","['circumferential lumbar fusion alone', 'circumferential single-level fusion (SLF']","['Progression of degeneration', 'radiological (MRI, X-ray) and clinical (ODI, VAS, satisfaction) evaluations assessed fusion, progression of adjacent segment degeneration (PASD), radiologically adverse events, functional outcome, and pain', 'radiological implant failure', 'Clinical scores', 'clinical scores', 'PASD']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0441635', 'cui_str': 'Segment (qualifier value)'}, {'cui': 'C0205117', 'cui_str': 'Juxta-posed (qualifier value)'}, {'cui': 'C1293131', 'cui_str': 'Fusion procedure (procedure)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0011164', 'cui_str': 'Degenerative abnormality'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by (contextual qualifier) (qualifier value)'}, {'cui': 'C0203206', 'cui_str': 'Discogram (procedure)'}]","[{'cui': 'C0205113', 'cui_str': 'Circumferential (qualifier value)'}, {'cui': 'C0024090', 'cui_str': 'Lumbar Region'}, {'cui': 'C1293131', 'cui_str': 'Fusion procedure (procedure)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]","[{'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0011164', 'cui_str': 'Degenerative abnormality'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1293131', 'cui_str': 'Fusion procedure (procedure)'}, {'cui': 'C3888829', 'cui_str': 'Adjacent segment degeneration'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0854676', 'cui_str': 'Failure of implant'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",30.0,0.0230748,"While no differences in clinical scores were observed between groups, improvement from pre-operative conditions was significant (all p < 0.001).","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Putzier', 'Affiliation': 'Clinic for Orthopaedics, Center for Musculoskeletal Surgery, Charité-Universitätsmedizin Berlin, Charitéplatz 1, 10117 Berlin, Germany. michael.putzier@charite.de'}, {'ForeName': 'Eike', 'Initials': 'E', 'LastName': 'Hoff', 'Affiliation': ''}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Tohtz', 'Affiliation': ''}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Gross', 'Affiliation': ''}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Perka', 'Affiliation': ''}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Strube', 'Affiliation': ''}]","European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society",['10.1007/s00586-010-1517-4']
945,20127495,Higher risk of dural tears and recurrent herniation with lumbar micro-endoscopic discectomy.,"Existing studies on micro-endoscopic lumbar discectomy report similar outcomes to those of open and microdiscectomy and conflicting results on complications. We designed a randomised controlled trial to investigate the hypothesis of different outcomes and complications obtainable with the three techniques. 240 patients aged 18-65 years affected by posterior lumbar disc herniation and symptoms lasting over 6 weeks of conservative management were randomised to micro-endoscopic (group 1), micro (group 2) or open (group 3) discectomy. Exclusion criteria were less than 6 weeks of pain duration, cauda equina compromise, foraminal or extra-foraminal herniations, spinal stenosis, malignancy, previous spinal surgery, spinal deformity, concurrent infection and rheumatic disease. Surgery and follow-up were made at a single Institution. A biomedical researcher independently collected and reviewed the data. ODI, back and leg VAS and SF-36 were the outcome measures used preoperatively, postoperatively and at 6-, 12- and 24-month follow-up. 212/240 (91%) patients completed the 24-month follow-up period. VAS back and leg, ODI and SF36 scores showed clinically and statistically significant improvements within groups without significant difference among groups throughout follow-up. Dural tears, root injuries and recurrent herniations were significantly more common in group 1. Wound infections were similar in group 2 and 3, but did not affect patients in group 1. Overall costs were significantly higher in group 1 and lower in group 3. In conclusion, outcome measures are equivalent 2 years following lumbar discectomy with micro-endoscopy, microscopy or open technique, but severe complications are more likely and costs higher with micro-endoscopy.",2010,"VAS back and leg, ODI and SF36 scores showed clinically and statistically significant improvements within groups without significant difference among groups throughout follow-up.","['212/240', '240 patients aged 18-65 years affected by posterior lumbar disc herniation and symptoms lasting over 6 weeks of conservative management']","['micro-endoscopic (group 1), micro (group 2) or open (group 3) discectomy', 'lumbar micro-endoscopic discectomy']","['ODI, back and leg VAS and SF-36', 'VAS back and leg, ODI and SF36 scores', 'Wound infections', 'Dural tears, root injuries and recurrent herniations', 'Overall costs']","[{'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0281899', 'cui_str': 'Prolapsed lumbar intervertebral disc (disorder)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0459914', 'cui_str': 'Conservative Management'}]","[{'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0441869', 'cui_str': 'Group 3 (qualifier value)'}, {'cui': 'C0206078', 'cui_str': 'Diskectomy'}, {'cui': 'C0024090', 'cui_str': 'Lumbar Region'}]","[{'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0043241', 'cui_str': 'Wound Infection'}, {'cui': 'C0563017', 'cui_str': 'Anal penetration using finger (finding)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",240.0,0.0439018,"VAS back and leg, ODI and SF36 scores showed clinically and statistically significant improvements within groups without significant difference among groups throughout follow-up.","[{'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Teli', 'Affiliation': 'Department of Spinal Surgery, Galeazzi Orthopaedic Institute, Via Galeazzi 4, 20161 Milan, Italy. marcoteli@hotmail.com'}, {'ForeName': 'Alessio', 'Initials': 'A', 'LastName': 'Lovi', 'Affiliation': ''}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Brayda-Bruno', 'Affiliation': ''}, {'ForeName': 'Antonino', 'Initials': 'A', 'LastName': 'Zagra', 'Affiliation': ''}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Corriero', 'Affiliation': ''}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'Giudici', 'Affiliation': ''}, {'ForeName': 'Leone', 'Initials': 'L', 'LastName': 'Minoia', 'Affiliation': ''}]","European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society",['10.1007/s00586-010-1290-4']
946,32430774,Effect of treatment with a full-occlusion biofeedback splint on sleep bruxism and TMD pain: a randomized controlled clinical trial.,"OBJECTIVES


The purpose of the present study was to analyze treatment outcome with a full-occlusion biofeedback (BFB) splint on sleep bruxism (SB) and TMD pain compared with treatment with an adjusted occlusal splint (AOS).
MATERIALS AND METHODS


Forty-one patients were randomly allocated to a test (BFB) or a control (AOS) group and monitored over a 3-month period. Output variables were frequency and duration of bruxing events (bursts) and various pain symptoms.
RESULTS


The BFB group showed a statistically significant reduction in the frequency and duration of bursts and a statistically significant improvement in the patients' global well-being and the facial muscle pain parameter. After the treatment was stopped, the BFB group showed a statistically significant reduction in the average and maximum duration but no statistically significant change in the frequency of bursts.
CONCLUSIONS


The tested BFB splint is highly effective in reducing SB at the subconscious level, i.e., without waking the patient, and in achieving improvements in global pain perception. The results suggest that the BFB splint also provides a better treatment option for bruxism-related pain than an AOS. However, further research is needed, and specifically studies with a larger patient population displaying higher levels of pain at baseline.
CLINICAL RELEVANCE


By reducing burst duration and therefore the pathological load on the masticatory apparatus, the BFB splint reduces TMD and bruxism-related symptoms and improves patients' physical well-being. In the long term, this could prevent damage to the TMJ. This study confirms the effectiveness and safety of this splint.
THE UNIVERSAL TRIAL NUMBER


U1111-1239-2450 DRKS-ID REGISTRATION: DRKS00018092.",2020,"After the treatment was stopped, the BFB group showed a statistically significant reduction in the average and maximum duration but no statistically significant change in the frequency of bursts.
",['Forty-one patients'],"['BFB splint', 'adjusted occlusal splint (AOS', 'test (BFB) or a control (AOS', 'full-occlusion biofeedback splint', 'full-occlusion biofeedback (BFB) splint']","['sleep bruxism (SB) and TMD pain', 'average and maximum duration', 'frequency and duration of bruxing events (bursts) and various pain symptoms', 'sleep bruxism and TMD pain', 'frequency of bursts', ""patients' global well-being and the facial muscle pain parameter"", 'frequency and duration of bursts', 'global pain perception']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0038009', 'cui_str': 'Splint'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0162528', 'cui_str': 'Occlusal appliance'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}]","[{'cui': 'C0751771', 'cui_str': 'Nocturnal Teeth Grinding Disorder'}, {'cui': 'C0039494', 'cui_str': 'Temporomandibular joint disorder'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0015460', 'cui_str': 'Facial Muscles'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}]",41.0,0.0790369,"After the treatment was stopped, the BFB group showed a statistically significant reduction in the average and maximum duration but no statistically significant change in the frequency of bursts.
","[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Bergmann', 'Affiliation': 'Department of Prosthetic Dentistry, University Hospital, LMU Munich, Goethestraße 70, 80336, Munich, Germany. Alexander.Bergmann@med.uni-muenchen.de.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Edelhoff', 'Affiliation': 'Department of Prosthetic Dentistry, University Hospital, LMU Munich, Goethestraße 70, 80336, Munich, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Schubert', 'Affiliation': 'Department of Prosthetic Dentistry, University Hospital, LMU Munich, Goethestraße 70, 80336, Munich, Germany.'}, {'ForeName': 'Kurt-Jürgen', 'Initials': 'KJ', 'LastName': 'Erdelt', 'Affiliation': 'Department of Prosthetic Dentistry, University Hospital, LMU Munich, Goethestraße 70, 80336, Munich, Germany.'}, {'ForeName': 'Jean-Marc', 'Initials': 'JM', 'LastName': 'Pho Duc', 'Affiliation': 'Department of Prosthetic Dentistry, University Hospital, LMU Munich, Goethestraße 70, 80336, Munich, Germany.'}]",Clinical oral investigations,['10.1007/s00784-020-03270-z']
947,31781822,Anti-phase cocontraction practice attenuates in-phase low-frequency oscillations between antagonistic muscles as assessed with phase coherence.,"Voluntary contraction of skeletal muscles involves common in-phase neural oscillations in low frequencies (around 1-2 Hz) across muscles. The purpose of this study was to determine if anti-phase antagonistic cocontraction practice can attenuate the occurrence of in-phase low-frequency oscillations in antagonistic muscle activity. For this purpose, we determined the probability density function of phase coherence in surface electromyogram (EMG) between antagonistic muscles. Healthy young adults were assigned to one of three intervention groups. They performed an isometric transient and steady cocontraction test with elbow flexors and extensors before and after a session of distinct intervention. In the Cocontraction group, subjects practiced alternating anti-phase isometric cocontraction with the flexors and extensors concurrently. In the Contraction group, subjects practiced alternating isometric contraction levels with flexors or extensors independently. Subjects in the Control group did not perform motor practice. The occurrence of in-phase coherence < 3 Hz during the cocontraction test (including transient and steady portions) was determined from the probability density function of phase coherence in rectified EMG between pairs of elbow flexor and extensor muscles. The change in the probability of in-phase coherence after the intervention period was greatest in the Cocontraction group, followed by Contraction group, and then Control group, on average. The Cocontraction group showed significantly greater reductions than the Control group across the cocontraction test portions. The results suggest that a session of anti-phase cocontraction practice can consistently attenuate the occurrence of in-phase low-frequency oscillations between cocontracting antagonistic muscles across steady and non-steady cocontractions in healthy young adults.",2020,"The change in the probability of in-phase coherence after the intervention period was greatest in the Cocontraction group, followed by Contraction group, and then Control group, on average.","['Healthy young adults', 'healthy young adults']",[],['probability of in-phase coherence'],"[{'cui': 'C0238598', 'cui_str': 'Young Adult'}]",[],"[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}]",,0.0129762,"The change in the probability of in-phase coherence after the intervention period was greatest in the Cocontraction group, followed by Contraction group, and then Control group, on average.","[{'ForeName': 'Nayef E', 'Initials': 'NE', 'LastName': 'Ahmar', 'Affiliation': 'School of Electrical and Computer Engineering, Georgia Institute of Technology, Atlanta, GA, 30332, USA.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Ueda', 'Affiliation': 'George W. Woodruff School of Mechanical Engineering, Georgia Institute of Technology, Atlanta, GA, 30332, USA.'}, {'ForeName': 'Minoru', 'Initials': 'M', 'LastName': 'Shinohara', 'Affiliation': 'School of Biological Sciences, Georgia Institute of Technology, 555 14th Street NW, Atlanta, GA, 30332-0356, USA. shinohara@gatech.edu.'}]",Experimental brain research,['10.1007/s00221-019-05700-1']
948,32106835,Who can we reach and who can we keep? Predictors of intervention engagement and adherence in a cluster randomized controlled trial in South Africa.,"BACKGROUND


Engaging and retaining young men in community-based interventions is highly challenging. The purpose of this study was to investigate the individual factors that predict intervention engagement and adherence in a sample of at-risk South African men.
METHODS


Baseline data were collected as a part of a cluster randomised control trial (RCT) situated in Khayelitsha and Mfuleni, two peri-urban settlements situated on the outskirts of Cape Town, South Africa. Neighbourhoods were randomised to one of three intervention conditions. We performed univariate descriptive statistics to report neighbourhood and individual socio-demographic factors, and ran multivariate models, adjusting for entry of study, to determine if high adherence and consistency of engagement with the intervention were associated with socio-behavioural demographics and risk behaviours, such as hazardous substance use, gangsterism, and criminal activity.
RESULTS


Total of 729 men were on average 22.5 years old (SD 2.8), with a mean of 10 years of education. More than half of the sample were single (94%), lived with their parents (66%) and had an income below ~$30 (52%). The overall mean of adherence is 0.41 (SD 0.24) and mean of consistency of engagement is 0.61 (SD 0.30). Our data indicated that completing more years of education, living with parents, and having higher socioeconomic status were significantly associated with higher rates of engagement and adherence. Men with a history of gang membership demonstrated higher levels of adherence and consistent engagement with the intervention, compared with other men who were recruited to the intervention. Crucially, our data show that young men with a history of substance use, and young men who report symptoms of depression and high levels of perceived stress are equally likely as other young men to adhere to the intervention and attend intervention sessions consistently.
CONCLUSION


Our results may contribute to a better understanding of young men's patterns of engagement and adherence to public health interventions. The results may have important implications for policy and practice, as they may be useful in planning more effective interventions and could potentially be used to predict which young men can be reached through community-based interventions.
TRIAL REGISTRATION


ClinicalTrials.gov registration, NCT02358226. Prospectively registered 24 November 2014.",2020,"Men with a history of gang membership demonstrated higher levels of adherence and consistent engagement with the intervention, compared with other men who were recruited to the intervention.","['Baseline data were collected as a part of a cluster randomised control trial (RCT) situated in Khayelitsha and Mfuleni, two peri-urban settlements situated on the outskirts of Cape Town, South Africa', 'Prospectively registered 24 November 2014', 'sample of at-risk South African men', 'South Africa', 'Men with a history of gang membership', 'Total of 729 men were on average 22.5\u2009years old (SD 2.8), with a mean of 10\u2009years of education']",[],['overall mean of adherence'],"[{'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0453952', 'cui_str': 'Cape (physical object)'}, {'cui': 'C0557750', 'cui_str': 'Towns'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517649', 'cui_str': 'Twenty-two point five'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0013621', 'cui_str': 'Education'}]",[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",729.0,0.0713061,"Men with a history of gang membership demonstrated higher levels of adherence and consistent engagement with the intervention, compared with other men who were recruited to the intervention.","[{'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Rabie', 'Affiliation': 'Institute for Life Course Health Research, Department of Global Health, Stellenbosch University, P O Box 241, Cape Town, 8000, South Africa. srabie@sun.ac.za.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Bantjes', 'Affiliation': 'Department of Psychology, Stellenbosch University, Private Bag X1, Matieland, 7602, South Africa.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Gordon', 'Affiliation': 'Institute for Life Course Health Research, Department of Global Health, Stellenbosch University, P O Box 241, Cape Town, 8000, South Africa.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Almirol', 'Affiliation': 'Department of Psychiatry & Biobehavioral Sciences, Semel Institute, University of California Los Angeles, 10920 Wilshire Blvd., Suite 350, Los Angeles, California, 90024, USA.'}, {'ForeName': 'Jackie', 'Initials': 'J', 'LastName': 'Stewart', 'Affiliation': 'Institute for Life Course Health Research, Department of Global Health, Stellenbosch University, P O Box 241, Cape Town, 8000, South Africa.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Tomlinson', 'Affiliation': 'Institute for Life Course Health Research, Department of Global Health, Stellenbosch University, P O Box 241, Cape Town, 8000, South Africa.'}, {'ForeName': 'Mary Jane', 'Initials': 'MJ', 'LastName': 'Rotheram-Borus', 'Affiliation': 'Department of Psychiatry & Biobehavioral Sciences, Semel Institute, University of California Los Angeles, 10920 Wilshire Blvd., Suite 350, Los Angeles, California, 90024, USA.'}]",BMC public health,['10.1186/s12889-020-8357-x']
949,31461138,Effect of Low-Dose Supplementation of Arginine Vasopressin on Need for Blood Product Transfusions in Patients With Trauma and Hemorrhagic Shock: A Randomized Clinical Trial.,"Importance


Current therapies for traumatic blood loss focus on hemorrhage control and blood volume replacement. Severe hemorrhagic shock, however, is associated with a state of arginine vasopressin (AVP) deficiency, and supplementation of this hormone may decrease the need for blood products in resuscitation.
Objective


To determine whether low-dose supplementation of AVP in patients with trauma (hereinafter referred to as trauma patients) and with hemorrhagic shock decreases their need for transfused blood products during resuscitation.
Design, Setting, and Participants


This randomized, double-blind placebo-controlled clinical trial included adult trauma patients (aged 18-65 years) who received at least 6 U of any blood product within 12 hours of injury at a single urban level 1 trauma center from May 1, 2013, through May 31, 2017. Exclusion criteria consisted of prehospital cardiopulmonary resuscitation, emergency department thoracotomy, corticosteroid use, chronic renal insufficiency, coronary artery disease, traumatic brain injury requiring any neurosurgical intervention, pregnancy, prisoner status, or AVP administration before enrollment. Data were analyzed from May 1, 2013, through May 31, 2017, using intention to treat and per protocol.
Interventions


After administration of an AVP bolus (4 U) or placebo, participants received AVP (≤0.04 U/min) or placebo for 48 hours to maintain a mean arterial blood pressure of at least 65 mm Hg.
Main Outcomes


The primary outcome was total volume of blood product transfused. Secondary end points included total volume of crystalloid transfused, vasopressor requirements, secondary complications, and 30-day mortality.
Results


One hundred patients underwent randomization (49 to the AVP group and 51 to the placebo group). Patients were primarily young (median age, 27 years [interquartile range {IQR}, 22-25 years]) and male (n = 93) with penetrating trauma (n = 79). Cohort characteristics before randomization were well balanced. At 48 hours, patients who received AVP required significantly less blood products (median, 1.4 [IQR, 0.5-2.6] vs 2.9 [IQR, 1.1-4.8] L; P = .01) but did not differ in requirements for crystalloids (median, 9.9 [IQR, 7.9-13.0] vs 11.0 [8.9-15.0] L; P = .22) or vasopressors (median, 400 [IQR, 0-5900] vs 1400 [IQR, 200-7600] equivalent units; P = .22). Although the groups had similar rates of mortality (6 of 49 [12%] vs 6 of 51 [12%]; P = .94) and total complications (24 of 44 [55%] vs 30 of 47 [64%]; P = .37), the AVP group had less deep venous thrombosis (5 of 44 [11%] vs 16 of 47 [34%]; P = .02).
Conclusions and Relevance


Low-dose AVP during the resuscitation of trauma patients in hemorrhagic shock decreases blood product requirements. Additional research is necessary to determine whether including AVP improves morbidity or mortality.
Trial Registration


ClinicalTrials.gov identifier: NCT01611935.",2019,"At 48 hours, patients who received AVP required significantly less blood products (median, 1.4 [IQR, 0.5-2.6] vs 2.9 [IQR, 1.1-4.8] L; P = .01) but did not differ in requirements for crystalloids (median, 9.9 [IQR, 7.9-13.0] vs 11.0 [8.9-15.0] L; P = .22) or vasopressors (median, 400 [IQR, 0-5900] vs 1400 [IQR, 200-7600] equivalent units; P = .22).","['Patients With Trauma and Hemorrhagic Shock', 'patients with trauma', 'adult trauma patients (aged 18-65 years) who received at least 6 U of any blood product within 12 hours of injury at a single urban level 1 trauma center from May 1, 2013, through May 31, 2017', 'Exclusion criteria consisted of prehospital cardiopulmonary resuscitation, emergency department thoracotomy, corticosteroid use, chronic renal insufficiency, coronary artery disease, traumatic brain injury requiring any neurosurgical intervention, pregnancy, prisoner status, or AVP administration before enrollment', 'Patients were primarily young (median age, 27 years [interquartile range {IQR}, 22-25 years]) and male (n\u2009=\u200993) with penetrating trauma (n\u2009=\u200979', 'One hundred patients underwent randomization (49 to the AVP group and 51 to the']","['AVP bolus (4 U) or placebo', 'AVP (≤0.04 U/min) or placebo', 'AVP', 'placebo', 'Arginine Vasopressin']","['Severe hemorrhagic shock', 'total complications', 'Blood Product Transfusions', 'total volume of crystalloid transfused, vasopressor requirements, secondary complications, and 30-day mortality', 'total volume of blood product transfused', 'deep venous thrombosis', 'rates of mortality', 'blood products']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0036982', 'cui_str': 'Shock, Hemorrhagic'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0456388', 'cui_str': 'Blood product (product)'}, {'cui': 'C1292430', 'cui_str': '12 hours'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0456947', 'cui_str': 'Level 1 (qualifier value)'}, {'cui': 'C0040786', 'cui_str': 'Trauma Centers'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0007203', 'cui_str': 'Cardio-Pulmonary Resuscitation'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0039991', 'cui_str': 'Thoracotomy'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0403447', 'cui_str': 'Renal Insufficiency, Chronic'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0876926', 'cui_str': 'TBI (Traumatic Brain Injury)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0033167', 'cui_str': 'Prisoners'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0205321', 'cui_str': 'Penetrating (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1532693', 'cui_str': 'Units per minute'}, {'cui': 'C0003779', 'cui_str': 'Argipressin'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0036982', 'cui_str': 'Shock, Hemorrhagic'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0005841', 'cui_str': 'Blood Transfusion'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0056562', 'cui_str': 'Crystalloid'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0456388', 'cui_str': 'Blood product (product)'}, {'cui': 'C0149871', 'cui_str': 'Deep Vein Thrombosis'}]",100.0,0.742006,"At 48 hours, patients who received AVP required significantly less blood products (median, 1.4 [IQR, 0.5-2.6] vs 2.9 [IQR, 1.1-4.8] L; P = .01) but did not differ in requirements for crystalloids (median, 9.9 [IQR, 7.9-13.0] vs 11.0 [8.9-15.0] L; P = .22) or vasopressors (median, 400 [IQR, 0-5900] vs 1400 [IQR, 200-7600] equivalent units; P = .22).","[{'ForeName': 'Carrie A', 'Initials': 'CA', 'LastName': 'Sims', 'Affiliation': 'Division of Traumatology, Surgical Critical Care, and Emergency Surgery, Department of Surgery, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Holena', 'Affiliation': 'Division of Traumatology, Surgical Critical Care, and Emergency Surgery, Department of Surgery, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Kim', 'Affiliation': 'Division of Traumatology, Surgical Critical Care, and Emergency Surgery, Department of Surgery, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Pascual', 'Affiliation': 'Division of Traumatology, Surgical Critical Care, and Emergency Surgery, Department of Surgery, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Smith', 'Affiliation': 'Division of Traumatology, Surgical Critical Care, and Emergency Surgery, Department of Surgery, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Neils', 'Initials': 'N', 'LastName': 'Martin', 'Affiliation': 'Division of Traumatology, Surgical Critical Care, and Emergency Surgery, Department of Surgery, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Seamon', 'Affiliation': 'Division of Traumatology, Surgical Critical Care, and Emergency Surgery, Department of Surgery, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Shiroff', 'Affiliation': 'Division of Traumatology, Surgical Critical Care, and Emergency Surgery, Department of Surgery, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Shariq', 'Initials': 'S', 'LastName': 'Raza', 'Affiliation': 'Division of Traumatology, Surgical Critical Care, and Emergency Surgery, Department of Surgery, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Lewis', 'Initials': 'L', 'LastName': 'Kaplan', 'Affiliation': 'Division of Traumatology, Surgical Critical Care, and Emergency Surgery, Department of Surgery, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Grill', 'Affiliation': 'Division of Traumatology, Surgical Critical Care, and Emergency Surgery, Department of Surgery, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Zimmerman', 'Affiliation': 'Department of Quantitative Health Sciences and Outcomes Research, Cleveland Clinic Foundation, Cleveland, Ohio.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Mason', 'Affiliation': 'Department of Anesthesia, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Abella', 'Affiliation': 'Department of Emergency Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Reilly', 'Affiliation': 'Division of Traumatology, Surgical Critical Care, and Emergency Surgery, Department of Surgery, University of Pennsylvania, Philadelphia.'}]",JAMA surgery,['10.1001/jamasurg.2019.2884']
950,32427280,Thyroid function in neonates conceived after hysterosalpingography with iodinated contrast.,"STUDY QUESTION


Does exposure to preconceptional hysterosalpingography (HSG) with iodinated oil-based contrast affect neonatal thyroid function as compared to iodinated water-based contrast?
SUMMARY ANSWER


Preconceptional HSG with iodinated contrast did not influence the neonatal thyroid function.
WHAT IS KNOWN ALREADY


HSG is a commonly applied tubal patency test during fertility work-up in which either oil- or water-based contrast is used. Oil-based contrast contains more iodine compared to water-based contrast. A previous study in an East Asian population found an increased risk of congenital hypothyroidism (CH) in neonates whose mothers were exposed to high amounts of oil-based contrast during HSG.
STUDY DESIGN, SIZE, DURATION


This is a retrospective data analysis of the H2Oil study, a randomized controlled trial (RCT) comparing HSG with the use of oil- versus water-based contrast during fertility work-up. After an HSG with oil-based contrast, 214 women had an ongoing pregnancy within 6 months leading to a live birth compared to 155 women after HSG with water-based contrast.
PARTICIPANTS/MATERIALS, SETTING, METHODS


Of the 369 women who had a live born infant, 208 consented to be approached for future research and 138 provided informed consent to collect data on the thyroid function tests of their offspring (n = 140). Thyroid function tests of these children were retrieved from the Dutch neonatal screening program, which includes the assessment of total thyroxine (T4) in all newborns, followed by thyroid-stimulating hormone only in those with a T4 level of ≤ -0.8 SD score. Furthermore, amount of contrast medium used and time between HSG and conception were compared between the two study groups.
MAIN RESULTS AND THE ROLE OF CHANCE


Data were collected from 140 neonates conceived after HSG with oil-based (n = 76) or water-based (n = 64) contrast. The median T4 concentration was 87.0 nmol/l [76.0-96.0] in the oil group and 90.0 nmol/l [78.0-106.0] in the water group (P = 0.13). None of the neonates had a positive screening result for CH.The median amount of contrast medium used was 9.0 ml [interquartile range (IQR), 6.0-11.8] in the oil-group and 10.0 ml [IQR, 7.5-14.0] in the water group (P = 0.43). No influence of the amount of contrast on the effect of contrast group on T4 concentrations was found (P-value for interaction, 0.37).
LIMITATIONS, REASONS FOR CAUTION


A relatively small sample size and possible attrition at follow-up are limitations of this study. Although our results suggest that the use of iodinated contrast media for HSG is safe for the offspring, the impact of a decrease in maternal thyroid function on offspring neurodevelopment could not be excluded, as data on maternal thyroid function after HSG and during conception were lacking.
WIDER IMPLICATIONS OF THE FINDINGS


As HSG with oil-based contrast does not affect thyroid function of the offspring, there is no reason to withhold this contrast to infertile women undergoing HSG. Future studies should investigate whether HSG with iodinated contrast influences the periconceptional maternal thyroid function and, consequently, offspring neurodevelopment.
STUDY FUNDING/COMPETING INTEREST(S)


This study received no funding. The original H2Oil RCT was an investigator-initiated study that was funded by the two academic institutions (Academic Medical Center and VU University Medical Center) of the Amsterdam UMC. The funders had no role in study design, collection, analysis and intrepretation of the data. I.R. reports receiving travel fee from Guerbet. C.B.L. reports speakers fee from Ferring in the past and research grants from Ferring, Merck and Guerbet. K.D. reports receiving travel fee and speakers fee from Guerbet. B.W.M. is supported by a NHMRC Practitioner Fellowship (GNT1082548). B.W.M. reports consultancy for ObsEva, Merck KGaA and Guerbet and travel and research grants from Merck KGaA and Guerbet. V.M. reports receiving travel fee and speakers fee as well as research grants from Guerbet. The other authors do not report conflicts of interest.
TRIAL REGISTRATION NUMBER


Netherlands Trial Register NTR 7526 (Neonates born after the H2Oil study), NTR 3270 (original H2Oil study), www.trialregister.nl.",2020,"No influence of the amount of contrast on the effect of contrast group on T4 concentrations was found (P-value for interaction, 0.37).
","['in all newborns, followed by thyroid-stimulating hormone only in those with a T4 level of ≤\u2009-0.8 SD score', 'infertile women undergoing HSG', 'NTR 7526 (Neonates born after the H2Oil study), NTR 3270 (original H2Oil study), www.trialregister.nl', 'East Asian population', 'Of the 369 women who had a live born infant', '208 consented to be approached for future research and 138 provided informed consent to collect data on the thyroid function tests of their offspring (n\u2009=\u2009140']","['Oil-based contrast contains more iodine', 'HSG']","['neonatal thyroid function', 'maternal thyroid function', 'Thyroid function', 'risk of congenital hypothyroidism (CH', 'median T4 concentration', 'total thyroxine (T4', 'T4 concentrations']","[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0040160', 'cui_str': 'Thyrotropin'}, {'cui': 'C0202231', 'cui_str': 'Thyroxine measurement'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0020709', 'cui_str': 'Hysterosalpingography'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0040130', 'cui_str': 'Thyroid panel'}, {'cui': 'C4319553', 'cui_str': '140'}]","[{'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0021966', 'cui_str': 'Iodide salt'}, {'cui': 'C0020709', 'cui_str': 'Hysterosalpingography'}]","[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0040132', 'cui_str': 'Thyroid structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0010308', 'cui_str': 'Congenital hypothyroidism'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040165', 'cui_str': 'levothyroxine'}]",214.0,0.03966,"No influence of the amount of contrast on the effect of contrast group on T4 concentrations was found (P-value for interaction, 0.37).
","[{'ForeName': 'N', 'Initials': 'N', 'LastName': 'van Welie', 'Affiliation': 'Department of Reproductive Medicine, Amsterdam UMC, Vrije Universiteit Amsterdam, De Boelelaan 1118, 1081 HV, Amsterdam, the Netherlands.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Roest', 'Affiliation': 'Department of Reproductive Medicine, Amsterdam UMC, Vrije Universiteit Amsterdam, De Boelelaan 1118, 1081 HV, Amsterdam, the Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Portela', 'Affiliation': 'Department of Reproductive Medicine, Amsterdam UMC, Vrije Universiteit Amsterdam, De Boelelaan 1118, 1081 HV, Amsterdam, the Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'van Rijswijk', 'Affiliation': 'Department of Reproductive Medicine, Amsterdam UMC, Vrije Universiteit Amsterdam, De Boelelaan 1118, 1081 HV, Amsterdam, the Netherlands.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Koks', 'Affiliation': 'Department of Obstetrics and Gynaecology, Máxima MC, De Run 4600, 5504 DB, Veldhoven, the Netherlands.'}, {'ForeName': 'C B', 'Initials': 'CB', 'LastName': 'Lambalk', 'Affiliation': 'Department of Reproductive Medicine, Amsterdam UMC, Vrije Universiteit Amsterdam, De Boelelaan 1118, 1081 HV, Amsterdam, the Netherlands.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Dreyer', 'Affiliation': 'Department of Reproductive Medicine, Amsterdam UMC, Vrije Universiteit Amsterdam, De Boelelaan 1118, 1081 HV, Amsterdam, the Netherlands.'}, {'ForeName': 'B W J', 'Initials': 'BWJ', 'LastName': 'Mol', 'Affiliation': 'Department of Obstetrics and Gynaecology, Monash University, Scenic Blvd, Clayton, VIC 3800, Australia.'}, {'ForeName': 'M J J', 'Initials': 'MJJ', 'LastName': 'Finken', 'Affiliation': ""Department of Paediatric Endocrinology, Amsterdam UMC, Vrije Universiteit Amsterdam, Emma Children's Hospital, De Boelelaan 1118, 1081 HV, Amsterdam, the Netherlands.""}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Mijatovic', 'Affiliation': 'Department of Reproductive Medicine, Amsterdam UMC, Vrije Universiteit Amsterdam, De Boelelaan 1118, 1081 HV, Amsterdam, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Human reproduction (Oxford, England)",['10.1093/humrep/deaa049']
951,20429017,Fusion mass bone quality after uninstrumented spinal fusion in older patients.,"Older people are at increased risk of non-union after spinal fusion, but little is known about the factors determining the quality of the fusion mass in this patient group. The aim of this study was to investigate fusion mass bone quality after uninstrumented spinal fusion and to evaluate if it could be improved by additional direct current (DC) electrical stimulation. A multicenter RCT compared 40 and 100 μA DC stimulation with a control group of uninstrumented posterolateral fusion in patients older than 60 years. This report comprised 80 patients who underwent DEXA scanning at the 1 year follow-up. The study population consisted of 29 men with a mean age of 72 years (range 62-85) and 51 women with a mean age of 72 years (range 61-84). All patients underwent DEXA scanning of their fusion mass. Fusion rate was assessed at the 2 year follow-up using thin slice CT scanning. DC electrical stimulation did not improve fusion mass bone quality. Smokers had lower fusion mass BMD (0.447 g/cm(2)) compared to non-smokers (0.517 g/cm(2)) (P = 0.086). Women had lower fusion mass BMD (0.460 g/cm(2)) compared to men (0.552 g/cm(2)) (P = 0.057). Using linear regression, fusion mass bone quality, measured as BMD, was significantly influenced by gender, age of the patient, bone density of the remaining part of the lumbar spine, amount of bone graft applied and smoking. Fusion rates in this cohort was 34% in the control group and 33 and 43% in the 40 and 100 μA groups, respectively (not significant). Patients classified as fused after 2 years had significant higher fusion mass BMD at 1 year (0.592 vs. 0.466 g/cm(2), P = 0.0001). Fusion mass bone quality in older patients depends on several factors. Special attention should be given to women with manifest or borderline osteoporosis. Furthermore, bone graft materials with inductive potential might be considered for this patient population.",2010,Smokers had lower fusion mass BMD (0.447 g/cm(2)) compared to non-smokers (0.517 g/cm(2)),"['29 men with a mean age of 72 years (range 62-85) and 51 women with a mean age of 72 years (range 61-84', '80 patients who underwent', 'women with manifest or borderline osteoporosis', 'patients older than 60 years', 'older patients', 'Older people']","['DC electrical stimulation', 'DEXA scanning']","['lower fusion mass BMD', 'fusion mass bone quality', 'Fusion rate', 'Fusion rates', 'fusion mass BMD']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205319', 'cui_str': 'Manifest (qualifier value)'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0013786', 'cui_str': 'Electrical Stimulation'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1293131', 'cui_str': 'Fusion procedure (procedure)'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]",29.0,0.0303718,Smokers had lower fusion mass BMD (0.447 g/cm(2)) compared to non-smokers (0.517 g/cm(2)),"[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Andersen', 'Affiliation': 'Spine Section, Orthopaedic Research Laboratory, Orthopaedic Department E, Aarhus University Hospital, Building 1A, Nørrebrogade 44, 8000 Aarhus C, Denmark. tba@dadlnet.dk'}, {'ForeName': 'Finn B', 'Initials': 'FB', 'LastName': 'Christensen', 'Affiliation': ''}, {'ForeName': 'Bente L', 'Initials': 'BL', 'LastName': 'Langdahl', 'Affiliation': ''}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Ernst', 'Affiliation': ''}, {'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Fruensgaard', 'Affiliation': ''}, {'ForeName': 'Jørgen', 'Initials': 'J', 'LastName': 'Ostergaard', 'Affiliation': ''}, {'ForeName': 'Jens Langer', 'Initials': 'JL', 'LastName': 'Andersen', 'Affiliation': ''}, {'ForeName': 'Sten', 'Initials': 'S', 'LastName': 'Rasmussen', 'Affiliation': ''}, {'ForeName': 'Bent', 'Initials': 'B', 'LastName': 'Niedermann', 'Affiliation': ''}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Høy', 'Affiliation': ''}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Helmig', 'Affiliation': ''}, {'ForeName': 'Randi', 'Initials': 'R', 'LastName': 'Holm', 'Affiliation': ''}, {'ForeName': 'Bent Erling', 'Initials': 'BE', 'LastName': 'Lindblad', 'Affiliation': ''}, {'ForeName': 'Ebbe Stender', 'Initials': 'ES', 'LastName': 'Hansen', 'Affiliation': ''}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Egund', 'Affiliation': ''}, {'ForeName': 'Cody', 'Initials': 'C', 'LastName': 'Bünger', 'Affiliation': ''}]","European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society",['10.1007/s00586-010-1373-2']
952,31833168,Improve Management of acute heart failure with ProcAlCiTonin in EUrope: results of the randomized clinical trial IMPACT EU Biomarkers in Cardiology (BIC) 18.,"AIM


To determine whether initiation of antibiotic therapy (ABX) by procalcitonin (PCT) within 8 h of admission in patients presenting to the emergency department with symptoms and signs of acute heart failure (AHF) and elevated natriuretic peptides would improve clinical outcomes.
METHODS AND RESULTS


The study was a randomized multicentre clinical trial conducted at 16 sites in Europe. Patients were randomized to either a PCT-guided strategy or standard care. Patients with PCT-guided strategy (n = 370) had ABX initiated if PCT was > 0.2 μg/L. Patients with standard care (n = 372) had AHF care in accordance with published guidelines without PCT. The primary endpoint was 90-day all-cause mortality. Pre-specified secondary endpoints included 30-day all-cause mortality and readmission and rate of pneumonia. The Data Safety and Review Committee recommended stopping the study for futility when 762 of the planned 792 patients had been enrolled. A total of 742 patients could be analysed. Patients were elderly (median age: 77 years), 38% were women, and had typical signs and symptoms of AHF. All-cause mortality at 90 days was 10.3% in the PCT-guided group vs. 8.2% in standard care (P = 0.316). Thirty-day readmission was significantly higher in the PCT-guided group vs. standard care but the difference vanished until day 90. The rate of pneumonia was overall low (7.5%) and not different between groups.
CONCLUSIONS


In patients with AHF, a strategy of PCT-guided initiation of ABX was not more effective than a standard care strategy in improving clinical outcomes.",2020,Thirty-day readmission was significantly higher in the PCT-guided group vs. standard care but the difference vanished until day 90.,"['762 of the planned 792 patients had been enrolled', 'Patients with PCT-guided strategy (n\xa0=\u2009370) had ABX initiated if PCT was >\u20090.2\xa0μg/L. Patients with standard care (n\xa0=\u2009372) had AHF care in accordance with published guidelines without PCT', 'patients presenting to the emergency department with symptoms and signs of acute heart failure (AHF) and elevated natriuretic peptides', '16 sites in Europe', 'A total of\u2009742 patients', 'Patients were elderly (median age: 77\u2009years), 38% were women, and had typical signs and symptoms of AHF', 'acute heart failure with ProcAlCiTonin in EUrope']","['PCT-guided strategy or standard care', 'antibiotic therapy (ABX) by procalcitonin (PCT']","['Thirty-day readmission', '90-day all-cause mortality', 'rate of pneumonia', '30-day all-cause mortality and readmission and rate of pneumonia']","[{'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0162566', 'cui_str': 'Porphyria Cutanea Tarda'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C4517743', 'cui_str': 'Three hundred and seventy'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0015506', 'cui_str': 'coagulation factor VIII'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0037088', 'cui_str': 'Signs and Symptoms'}, {'cui': 'C0264714', 'cui_str': 'Acute heart failure (disorder)'}, {'cui': 'C1144709', 'cui_str': 'Natriuretic Peptides'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1535922', 'cui_str': 'Procalcitonin'}]","[{'cui': 'C0162566', 'cui_str': 'Porphyria Cutanea Tarda'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0338237', 'cui_str': 'Antibiotic therapy (procedure)'}, {'cui': 'C1535922', 'cui_str': 'Procalcitonin'}]","[{'cui': 'C0030700', 'cui_str': 'Thirty Day Readmission'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}]",742.0,0.126475,Thirty-day readmission was significantly higher in the PCT-guided group vs. standard care but the difference vanished until day 90.,"[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Möckel', 'Affiliation': 'Department of Cardiology, Division of Emergency and Acute Medicine Campus Charité Mitte and Virchow-Klinikum, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Rudolf A', 'Initials': 'RA', 'LastName': 'de Boer', 'Affiliation': 'Department of Cardiology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Anna Christine', 'Initials': 'AC', 'LastName': 'Slagman', 'Affiliation': 'Department of Cardiology, Division of Emergency and Acute Medicine Campus Charité Mitte and Virchow-Klinikum, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'von Haehling', 'Affiliation': 'Department of Cardiology and Pneumology, University of Goettingen Medical Center, Goettingen, Germany and German Center for Cardiovascular Research (DZHK), partner site Goettingen, Germany.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Schou', 'Affiliation': 'Department of Cardiology, Herlev and Gentofte Hospital, University of Copenhagen, Herlev, Denmark.'}, {'ForeName': 'Jörn Ole', 'Initials': 'JO', 'LastName': 'Vollert', 'Affiliation': 'Clinical Diagnostics, Thermo Fisher Scientific, Hennigsdorf, Germany.'}, {'ForeName': 'Jan C', 'Initials': 'JC', 'LastName': 'Wiemer', 'Affiliation': 'Clinical Diagnostics, Thermo Fisher Scientific, Hennigsdorf, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Ebmeyer', 'Affiliation': 'Clinical Diagnostics, Thermo Fisher Scientific, Hennigsdorf, Germany.'}, {'ForeName': 'F Javier', 'Initials': 'FJ', 'LastName': 'Martín-Sánchez', 'Affiliation': 'Emergency Department, Hospital Clínico San Carlos, Instituto de Investigación Sanitaria Hospital Clínico San Carlos (IdISSC), Universidad Complutense de Madrid, Madrid, Spain.'}, {'ForeName': 'Alan S', 'Initials': 'AS', 'LastName': 'Maisel', 'Affiliation': 'University of California, San Diego, CA, USA.'}, {'ForeName': 'Evangelos', 'Initials': 'E', 'LastName': 'Giannitsis', 'Affiliation': 'Abteilung Innere Medizin III Kardiologie, Angiologie und Pneumologie, Medizinische Universitätsklinik Heidelberg, Heidelberg, Germany.'}]",European journal of heart failure,['10.1002/ejhf.1667']
953,32427675,Allogenic Fecal Microbiota Transplantation in Patients With Nonalcoholic Fatty Liver Disease Improves Abnormal Small Intestinal Permeability: A Randomized Control Trial.,"INTRODUCTION


Nonalcoholic fatty liver disease (NAFLD) is an obesity-related disorder that is rapidly increasing in incidence and is considered the hepatic manifestation of the metabolic syndrome. The gut microbiome plays a role in metabolism and maintaining gut barrier integrity. Studies have found differences in the microbiota between NAFLD and healthy patients and increased intestinal permeability in patients with NAFLD. Fecal microbiota transplantation (FMT) can be used to alter the gut microbiome. It was hypothesized that an FMT from a thin and healthy donor given to patients with NAFLD would improve insulin resistance (IR), hepatic proton density fat fraction (PDFF), and intestinal permeability.
METHODS


Twenty-one patients with NAFLD were recruited and randomized in a ratio of 3:1 to either an allogenic (n = 15) or an autologous (n = 6) FMT delivered by using an endoscope to the distal duodenum. IR was calculated by HOMA-IR, hepatic PDFF was measured by MRI, and intestinal permeability was tested using the lactulose:mannitol urine test. Additional markers of metabolic syndrome and the gut microbiota were examined. Patient visits occurred at baseline, 2, 6 weeks, and 6 months post-FMT.
RESULTS


There were no significant changes in HOMA-IR or hepatic PDFF in patients who received the allogenic or autologous FMT. Allogenic FMT patients with elevated small intestinal permeability (>0.025 lactulose:mannitol, n = 7) at baseline had a significant reduction 6 weeks after allogenic FMT.
DISCUSSION


FMT did not improve IR as measured by HOMA-IR or hepatic PDFF but did have the potential to reduce small intestinal permeability in patients with NAFLD.",2020,There were no significant changes in HOMA-IR or hepatic PDFF in patients who received the allogenic or autologous FMT.,"['Patients With Nonalcoholic Fatty Liver Disease Improves', 'patients with NAFLD', 'Twenty-one patients with NAFLD', 'Abnormal Small Intestinal Permeability']","['Allogenic Fecal Microbiota Transplantation', 'Fecal microbiota transplantation (FMT', 'allogenic (n = 15) or an autologous (n = 6) FMT delivered by using an endoscope to the distal duodenum', 'FMT', 'allogenic or autologous FMT', 'Allogenic FMT']","['HOMA-IR or hepatic PDFF', 'Patient visits', 'intestinal permeability', 'insulin resistance (IR), hepatic proton density fat fraction (PDFF), and intestinal permeability', 'small intestinal permeability', 'HOMA-IR, hepatic PDFF was measured by MRI, and intestinal permeability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0021852', 'cui_str': 'Small intestinal'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}]","[{'cui': 'C2242628', 'cui_str': 'Fecal microbiota transplantation'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0014243', 'cui_str': 'Endoscope'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0013303', 'cui_str': 'Duodenal'}]","[{'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0033727', 'cui_str': 'Proton'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}, {'cui': 'C0021852', 'cui_str': 'Small intestinal'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]",21.0,0.0335215,There were no significant changes in HOMA-IR or hepatic PDFF in patients who received the allogenic or autologous FMT.,"[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Craven', 'Affiliation': 'Department of Microbiology and Immunology, Western University, London, Ontario, Canada.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Rahman', 'Affiliation': 'Lawson Health Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Seema', 'Initials': 'S', 'LastName': 'Nair Parvathy', 'Affiliation': ""Division of Infectious Disease, St. Joseph's Health Care, London, Ontario, Canada.""}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Beaton', 'Affiliation': 'Lawson Health Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Silverman', 'Affiliation': 'Program in Computational Biology and Bioinformatics, Duke University, Durham, North Carolina, USA.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Qumosani', 'Affiliation': 'Lawson Health Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Hramiak', 'Affiliation': 'Lawson Health Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Hegele', 'Affiliation': 'Lawson Health Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Tisha', 'Initials': 'T', 'LastName': 'Joy', 'Affiliation': 'Lawson Health Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Meddings', 'Affiliation': 'Department of Medicine, University of Calgary, Alberta, Canada.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Urquhart', 'Affiliation': 'Lawson Health Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Harvie', 'Affiliation': 'The Canadian Centre for Microbiome and Probiotic Research, London, Ontario, Canada.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'McKenzie', 'Affiliation': 'Lawson Health Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Summers', 'Affiliation': 'Department of Microbiology and Immunology, Western University, London, Ontario, Canada.'}, {'ForeName': 'Gregor', 'Initials': 'G', 'LastName': 'Reid', 'Affiliation': 'Department of Microbiology and Immunology, Western University, London, Ontario, Canada.'}, {'ForeName': 'Jeremy P', 'Initials': 'JP', 'LastName': 'Burton', 'Affiliation': 'Department of Microbiology and Immunology, Western University, London, Ontario, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Silverman', 'Affiliation': 'Department of Microbiology and Immunology, Western University, London, Ontario, Canada.'}]",The American journal of gastroenterology,['10.14309/ajg.0000000000000661']
954,18033153,"[Atomoxetine (Strattera), an alternative in the treatment of attention-deficit/hyperactivity disorder (ADHD) in children].","INTRODUCTION


Atomoxetine (Strattera) is the first non-stimulant drug to be approved for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children 6 years of age and adolescents. Atomoxetine is a highly specific inhibitor of the presynaptic norepinephrine transporter, with minimal affinity for other transporters or other neurotransmitter receptors. The target dose is 1.2 mg/kg, in a once- or twice-daily oral administration.
CLINICAL DATA


Six randomized, double blind, placebo-controlled clinical trials have demonstrated that atomoxetine was more effective than placebo for the treatment of children and adolescents with ADHD. All these trials have shown a consistent improvement in the ADHD rating scale (ADHD-RS) from baseline in the patients treated with atomoxetine, compared with that of the placebo group. The improvement of ADHD symptoms was confirmed by the other secondary efficacy measures (the Clinical Global Impression, CGI, the Conners ADHD rating scale/parent, teacher). The duration of action of atomoxetine on ADHD symptoms extended throughout the waking hours, and the drug effects persisted up to the next morning with a single morning dose. Significant improvements were also observed with atomoxetine compared to placebo, in several aspects of the quality of life measurement (social and family functioning), and the child's self-esteem. In addition, in patients who responded favourably to initial treatment, atomoxetine was shown to be superior to placebo in maintaining a long term-response, up to 18 months. Atomoxetine was effective and safe, both in young children and adolescents with ADHD. Preliminary data also support the potential efficacy of atomoxetine in managing patients with ADHD and comorbid conditions, such as tic disorders, oppositional-defiant and conduct disorders.
DISCUSSION


As of June 2004, over 3,000 children and adolescents have been enrolled in clinical trials of atomoxetine, with about 1,200 of them treated for more than 1 year and about 400 of them treated for more than 2 years. Atomoxetine was well tolerated in most individuals, the two more common adverse events reported were gastro-intestinal disorders and decreased appetite. These side effects were generally noted to be transient. No significant changes in weight and height gain was reported over the long-term follow-up. There was no evidence of symptoms rebound and no evidence of an acute discontinuation syndrome when discontinuing treatment. In addition, given the mechanism of action of atomoxetine in the central nervous system, and lack of subjective, physiological and psychomotor effects reported in experimental conditions, it is unlikely that atomoxetine would have abuse potential.
CONCLUSION


Results from clinical trials demonstrated that atomoxetine is effective and well tolerated for the acute and long-term treatment of children and adolescents suffering from ADHD. Atomoxetine should be considered as a new interesting pharmacological option in the treatment of ADHD in association with non pharmacological therapeutic interventions.",2007,"Significant improvements were also observed with atomoxetine compared to placebo, in several aspects of the quality of life measurement (social and family functioning), and the child's self-esteem.","['children 6 years of age and adolescents', '3,000 children and adolescents have been enrolled in clinical trials of atomoxetine, with about 1,200 of them treated for more than 1 year and about 400 of them treated for more than 2 years', 'attention-deficit/hyperactivity disorder (ADHD) in children', 'children and adolescents with ADHD', 'young children and adolescents with ADHD', 'children and adolescents suffering from ADHD']","['Atomoxetine (Strattera', 'atomoxetine', 'placebo', 'Atomoxetine']","['appetite', 'acute discontinuation syndrome', 'ADHD symptoms', 'side effects', 'tolerated', 'Clinical Global Impression, CGI, the Conners ADHD rating scale/parent, teacher', ""quality of life measurement (social and family functioning), and the child's self-esteem"", 'ADHD rating scale (ADHD-RS', 'weight and height gain', 'effective and well tolerated']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0076823', 'cui_str': 'atomoxetine'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for (contextual qualifier) (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0205172', 'cui_str': 'More (qualifier value)'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}]","[{'cui': 'C0076823', 'cui_str': 'atomoxetine'}, {'cui': 'C1176420', 'cui_str': 'Strattera'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C0034380'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0036597', 'cui_str': 'Self Esteem'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}]",3000.0,0.0785031,"Significant improvements were also observed with atomoxetine compared to placebo, in several aspects of the quality of life measurement (social and family functioning), and the child's self-esteem.","[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Gaillez', 'Affiliation': 'Département Médical, Unité thérapeutique Système Nerveux Central, Laboratoires Lilly France, 13, rue Pagès, 92158 Suresnes cedex.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Sorbara', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Perrin', 'Affiliation': ''}]",L'Encephale,[]
955,32119742,Daily Preventive Zinc Supplementation Decreases Lymphocyte and Eosinophil Concentrations in Rural Laotian Children from Communities with a High Prevalence of Zinc Deficiency: Results of a Randomized Controlled Trial.,"BACKGROUND


Zinc deficiency impairs immune function and is common among children in South-East Asia.
OBJECTIVES


The effect of zinc supplementation on immune function in young Laotian children was investigated.
METHODS


Children (n = 512) aged 6-23 mo received daily preventive zinc tablets (PZ; 7 mg Zn/d), daily multiple micronutrient powder (MNP; 10 mg Zn/d, 6 mg Fe/d, plus 13 other micronutrients), therapeutic dispersible zinc tablets only in association with diarrhea episodes (TZ; 20 mg Zn/d for 10 d after an episode), or daily placebo powder (control). These interventions continued for 9 mo. Cytokine production from whole blood cultures, the concentrations of T-cell populations, and a complete blood count with differential leukocyte count were measured at baseline and endline. Endline means were compared via ANCOVA, controlling for the baseline value of the outcome, child age and sex, district, month of enrollment, and baseline zinc status (below, or above or equal to, the median plasma zinc concentration).
RESULTS


T-cell cytokines (IL-2, IFN-γ, IL-13, IL-17), LPS-stimulated cytokines (IL-1β, IL-6, TNF-α, and IL-10), and T-cell concentrations at endline did not differ between intervention groups, nor was there an interaction with baseline zinc status. However, mean ± SE endline lymphocyte concentrations were significantly lower in the PZ than in the control group (5018 ± 158 compared with 5640 ± 160 cells/μL, P = 0.032). Interactions with baseline zinc status were seen for eosinophils (Pixn = 0.0036), basophils (Pixn = 0.023), and monocytes (P = 0.086) but a significant subgroup difference was seen only for eosinophils, where concentrations were significantly lower in the PZ than in the control group among children with baseline plasma zinc concentrations below the overall median (524 ± 44 compared with 600 ± 41 cells/μL, P = 0.012).
CONCLUSIONS


Zinc supplementation of rural Laotian children had no effect on cytokines or T-cell concentrations, although zinc supplementation affected lymphocyte and eosinophil concentrations. These cell subsets may be useful as indicators of response to zinc supplementation.This trial was registered at clinicaltrials.gov as NCT02428647.",2020,"RESULTS


T-cell cytokines (IL-2, IFN-γ, IL-13, IL-17), LPS-stimulated cytokines (IL-1β, IL-6, TNF-α, and IL-10), and T-cell concentrations at endline did not differ between intervention groups, nor was there an interaction with baseline zinc status.","['Children (n\xa0=\xa0512) aged 6-23\xa0mo received', 'children in South-East Asia', 'rural Laotian children', 'young Laotian children', 'Rural Laotian Children from Communities with a High Prevalence of Zinc Deficiency']","['daily preventive zinc tablets (PZ; 7\xa0mg Zn/d), daily multiple micronutrient powder (MNP; 10\xa0mg Zn/d, 6\xa0mg', 'PZ', 'placebo powder (control', 'zinc supplementation', 'Daily Preventive Zinc Supplementation']","['T-cell cytokines (IL-2, IFN-γ, IL-13, IL-17), LPS-stimulated cytokines (IL-1β, IL-6, TNF-α, and IL-10), and T-cell concentrations', 'cytokines or T-cell concentrations', 'immune function', 'Lymphocyte and Eosinophil Concentrations', 'mean\xa0±\xa0SE endline lymphocyte concentrations', 'lymphocyte and eosinophil concentrations', 'complete blood count with differential leukocyte count']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0015631', 'cui_str': 'East Asia'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0235950', 'cui_str': 'Zinc deficiency (disorder)'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1456501', 'cui_str': 'Preventive'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0282575', 'cui_str': 'Micronutrients'}, {'cui': 'C0032861', 'cui_str': 'Powdered drug preparation'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4524022', 'cui_str': 'Zinc supplementation'}]","[{'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0021756', 'cui_str': 'TCGF'}, {'cui': 'C0214743', 'cui_str': 'IL13'}, {'cui': 'C0384648', 'cui_str': 'IL-17'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C4018897', 'cui_str': 'Lymphocyte component of blood'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil, segmented (cell)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0009555', 'cui_str': 'Complete Blood Count'}, {'cui': 'C0162401', 'cui_str': 'Leukocyte Count, Differential'}]",,0.450992,"RESULTS


T-cell cytokines (IL-2, IFN-γ, IL-13, IL-17), LPS-stimulated cytokines (IL-1β, IL-6, TNF-α, and IL-10), and T-cell concentrations at endline did not differ between intervention groups, nor was there an interaction with baseline zinc status.","[{'ForeName': 'Chidchamai', 'Initials': 'C', 'LastName': 'Kewcharoenwong', 'Affiliation': 'The Centre for Research & Development of Medical Diagnostic Laboratories, Faculty of Associated Medical Sciences, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Gertrud U', 'Initials': 'GU', 'LastName': 'Schuster', 'Affiliation': 'Institute for Global Nutrition, Department of Nutrition, University of California, Davis, CA, USA.'}, {'ForeName': 'K Ryan', 'Initials': 'KR', 'LastName': 'Wessells', 'Affiliation': 'Institute for Global Nutrition, Department of Nutrition, University of California, Davis, CA, USA.'}, {'ForeName': 'Guy-Marino', 'Initials': 'GM', 'LastName': 'Hinnouho', 'Affiliation': 'Institute for Global Nutrition, Department of Nutrition, University of California, Davis, CA, USA.'}, {'ForeName': 'Maxwell A', 'Initials': 'MA', 'LastName': 'Barffour', 'Affiliation': 'Institute for Global Nutrition, Department of Nutrition, University of California, Davis, CA, USA.'}, {'ForeName': 'Sengchanh', 'Initials': 'S', 'LastName': 'Kounnavong', 'Affiliation': ""Lao Tropical and Public Health Institute, Vientiane, Lao People's Democratic Republic.""}, {'ForeName': 'Kenneth H', 'Initials': 'KH', 'LastName': 'Brown', 'Affiliation': 'Institute for Global Nutrition, Department of Nutrition, University of California, Davis, CA, USA.'}, {'ForeName': 'Sonja Y', 'Initials': 'SY', 'LastName': 'Hess', 'Affiliation': 'Institute for Global Nutrition, Department of Nutrition, University of California, Davis, CA, USA.'}, {'ForeName': 'Waraporn', 'Initials': 'W', 'LastName': 'Samer', 'Affiliation': 'The Centre for Research & Development of Medical Diagnostic Laboratories, Faculty of Associated Medical Sciences, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Inthira', 'Initials': 'I', 'LastName': 'Tussakhon', 'Affiliation': 'The Centre for Research & Development of Medical Diagnostic Laboratories, Faculty of Associated Medical Sciences, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Janet M', 'Initials': 'JM', 'LastName': 'Peerson', 'Affiliation': 'Agricultural Research Service, Western Human Nutrition Research Center, USDA, Davis, CA, USA.'}, {'ForeName': 'Ganjana', 'Initials': 'G', 'LastName': 'Lertmemongkolchai', 'Affiliation': 'The Centre for Research & Development of Medical Diagnostic Laboratories, Faculty of Associated Medical Sciences, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Charles B', 'Initials': 'CB', 'LastName': 'Stephensen', 'Affiliation': 'Institute for Global Nutrition, Department of Nutrition, University of California, Davis, CA, USA.'}]",The Journal of nutrition,['10.1093/jn/nxaa037']
956,17550422,Study design of the Trial to Reduce IDDM in the Genetically at Risk (TRIGR).,"The hypothesis for this study is that weaning to an extensively hydrolyzed infant formula will decrease the incidence of type 1 diabetes (T1D), as it does in all relevant animal models for the disease. This will be tested in children who carry risk-associated human leukocyte antigen genotypes and have a first-degree relative with T1D. The trial will use a double-blind, prospective, placebo-controlled intervention protocol, comparing casein hydrolysate with a conventional cow's milk (CM)-based formula. A secondary aim is to determine relationships between CM antibodies, a measure of CM exposure, and diabetes-associated autoantibodies. To achieve an 80% power for the detection of a 40% intervention-induced difference in the development of autoantibodies and subsequent diabetes, the study requires 2032 subjects. A multicenter, international, collaborative effort is necessary to achieve recruitment targets. A collaborative international study group of 78 clinical centers in 15 countries has therefore been assembled for this purpose.",2007,"To achieve an 80% power for the detection of a 40% intervention-induced difference in the development of autoantibodies and subsequent diabetes, the study requires 2032 subjects.","['children who carry risk-associated human leukocyte antigen genotypes and have a first-degree relative with T1D', '2032 subjects', '78 clinical centers in 15 countries']","[""casein hydrolysate with a conventional cow's milk (CM)-based formula"", 'placebo']",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0427359', 'cui_str': 'Human leukocyte antigen genotype'}, {'cui': 'C0444502', 'cui_str': 'First degree (qualifier value)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}]","[{'cui': 'C0054845', 'cui_str': 'casein hydrolysate'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0349374', 'cui_str': ""Cow's milk (substance)""}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]",[],2032.0,0.171524,"To achieve an 80% power for the detection of a 40% intervention-induced difference in the development of autoantibodies and subsequent diabetes, the study requires 2032 subjects.","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': 'Pediatrics Epidemiology Center, University of South Florida, 3650 Spectrum Boulevard, Suite 100, Tampa, FL 33612, USA.'}]",Pediatric diabetes,[]
957,32036492,Randomized phase II/III study of 5-fluorouracil/l-leucovorin versus 5-fluorouracil/l-leucovorin plus paclitaxel administered to patients with severe peritoneal metastases of gastric cancer (JCOG1108/WJOG7312G).,"BACKGROUND


Oral fluoropyrimidine plus cisplatin is often not tolerated by patients with severe peritoneal metastases of gastric cancer. Combination of 5-fluorouracil (5-FU), l-leucovorin (l-LV), and paclitaxel (FLTAX) has promising activity for such patients. We conducted a phase II/III study comparing FLTAX with 5-FU/l-LV.
METHODS


Eligibility criteria included: unresectable or recurrent gastric adenocarcinoma; 20-75 years; performance status (PS) 0-2; peritoneal metastases + ; massive ascites and/or inadequate oral intake; no prior chemotherapy. Patients were randomly assigned to receive 5-FU/l-LV or FLTAX. The primary endpoint of phase III was overall survival: UMIN000010949.
RESULTS


We enrolled 101 patients. Early deaths occurred in patients with PS 2 having massive ascites and inadequate oral intake simultaneously; the protocol was amended to exclude such patients. Median survival times were 6.1 and 7.3 months for the 5-FU/l-LV and the FLTAX arms, respectively (HR 0.792; 80% CI 0.596-1.053; one-sided p = 0.1445). FLTAX arm had longer progression-free survival (PFS) [1.9 vs 5.4 months (HR 0.64; 95% CI, 0.43-0.96; p = 0.029)]. Grade 3/4 adverse events such as leucopenia and anorexia were more frequently observed in the 5-FU/l-LV arm. In the 5-FU/l-LV arm, two deaths were treatment-related. In the 5-FU/l-LV and FLTAX arms, 12 and 3 deaths occurred within 30 days after the last protocol treatment, respectively.
CONCLUSIONS


Chemotherapy was indicated for patients with severe peritoneal metastases excluding patients with PS 2 having massive ascites and inadequate oral intake simultaneously. FLTAX did not confer a significant survival benefit but may be preferred because of longer PFS and acceptable toxicity.",2020,"FLTAX arm had longer progression-free survival (PFS) [1.9 vs 5.4 months (HR 0.64; 95% CI, 0.43-0.96; p = 0.029)].","['We enrolled 101 patients', 'patients with severe peritoneal metastases of gastric cancer', 'patients with severe peritoneal metastases excluding patients with PS 2 having massive ascites and inadequate oral intake simultaneously', 'patients with severe peritoneal metastases of gastric cancer (JCOG1108/WJOG7312G', 'Eligibility criteria included: unresectable or recurrent gastric adenocarcinoma; 20-75\xa0years; performance status (PS) 0-2; peritoneal metastases\u2009+\u2009; massive ascites and/or inadequate oral intake; no prior chemotherapy']","['FLTAX with 5-FU/l-LV', 'FLTAX', '5-fluorouracil/l-leucovorin versus 5-fluorouracil/l-leucovorin plus paclitaxel', '5-FU/l-LV or FLTAX', '5-FU/l-LV and FLTAX', '5-FU/l-LV', 'fluoropyrimidine plus cisplatin', '5-fluorouracil (5-FU), l-leucovorin (l-LV), and paclitaxel (FLTAX']","['Early deaths', 'Median survival times', 'Grade 3/4 adverse events such as leucopenia and anorexia', 'longer progression-free survival (PFS', 'overall survival: UMIN000010949']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0346989', 'cui_str': 'Secondary malignant peritoneal deposit'}, {'cui': 'C0024623', 'cui_str': 'Cancer of Stomach'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0522501', 'cui_str': 'Massive (qualifier value)'}, {'cui': 'C0003962', 'cui_str': 'Ascites'}, {'cui': 'C3714435', 'cui_str': 'Inadequate oral intake (finding)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C2721771', 'cui_str': 'levoleucovorin'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0750394', 'cui_str': 'Decreased blood leukocyte number (finding)'}, {'cui': 'C1971624', 'cui_str': 'Loss of appetite (finding)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",101.0,0.0523077,"FLTAX arm had longer progression-free survival (PFS) [1.9 vs 5.4 months (HR 0.64; 95% CI, 0.43-0.96; p = 0.029)].","[{'ForeName': 'Takako Eguchi', 'Initials': 'TE', 'LastName': 'Nakajima', 'Affiliation': 'Department of Clinical Oncology, St. Marianna University School of Medicine, 2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa, 216-8511, Japan. tnakajima@marianna-u.ac.jp.'}, {'ForeName': 'Kensei', 'Initials': 'K', 'LastName': 'Yamaguchi', 'Affiliation': 'Department of Gastroenterology, The Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.'}, {'ForeName': 'Narikazu', 'Initials': 'N', 'LastName': 'Boku', 'Affiliation': 'Department of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Ichinosuke', 'Initials': 'I', 'LastName': 'Hyodo', 'Affiliation': 'Department of Gastroenterology, University of Tsukuba, Tsukuba, Japan.'}, {'ForeName': 'Junki', 'Initials': 'J', 'LastName': 'Mizusawa', 'Affiliation': 'Japan Clinical Oncology Group (JCOG) Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Hara', 'Affiliation': 'Department of Gastroenterology, Saitama Cancer Center, Saitama, Japan.'}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Nishina', 'Affiliation': 'Department of Gastrointestinal Medical Oncology, National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Sakamoto', 'Affiliation': 'Department of Gastroenterology, Hyogo Cancer Center, Akashi, Japan.'}, {'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Shitara', 'Affiliation': 'Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Katsunori', 'Initials': 'K', 'LastName': 'Shinozaki', 'Affiliation': 'Division of Clinical Oncology, Hiroshima Prefectural Hospital, Hiroshima, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Katayama', 'Affiliation': 'Japan Clinical Oncology Group (JCOG) Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Shinichiro', 'Initials': 'S', 'LastName': 'Nakamura', 'Affiliation': 'West Japan Oncology Group (WJOG) Data Center Division, Yokohama, Japan.'}, {'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Muro', 'Affiliation': 'Department of Clinical Oncology, Aichi Cancer Center, Nagoya, Japan.'}, {'ForeName': 'Masanori', 'Initials': 'M', 'LastName': 'Terashima', 'Affiliation': 'Department of Gastrointestinal Oncology, Shizuoka Cancer Center, Nagaizumi, Japan.'}]",Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association,['10.1007/s10120-020-01043-x']
958,31499227,Health coaching to improve self-care of informal caregivers of adults with chronic heart failure - iCare4Me: Study protocol for a randomized controlled trial.,"BACKGROUND


Persons with chronic heart failure are living longer. These patients typically live in the community and are cared for at home by informal caregivers. These caregivers are an understudied and stressed group.
METHODS


We are conducting a two-arm, randomized controlled trial of 250 caregivers of persons with chronic heart failure to evaluate the efficacy of a health coaching intervention. A consecutive sample of participants is being enrolled from both clinic and hospital settings at a single institution affiliated with a large medical center in the northeastern US. Both the intervention and control groups receive tablets programmed to provide standardized health information. In addition, the intervention group receives 10 live coaching sessions delivered virtually by health coaches using the tablets. The intervention is evaluated at 6-months, with self-care as the primary outcome. Cost-effectiveness of the intervention is evaluated at 12-months. We are also enrolling heart failure patients (dyads) whenever possible to explore the effect of caregiver outcomes (self-care, stress, coping, health status) on heart failure patient outcomes (number of hospitalizations and days in the hospital) at 12-months.
DISCUSSION


We expect the proposed study to require 5 years for completion. If shown to be efficacious and cost-effective, our virtual health coaching intervention can easily be scaled to. support millions of caregivers worldwide.",2019,"If shown to be efficacious and cost-effective, our virtual health coaching intervention can easily be scaled to.","['informal caregivers of adults with chronic heart failure - iCare4Me', 'enrolling heart failure patients (dyads', '250 caregivers of persons with chronic heart failure', 'patients typically live in the community and are cared for at home by informal caregivers', 'Persons with chronic heart failure', 'A consecutive sample of participants is being enrolled from both clinic and hospital settings at a single institution affiliated with a large medical center in the northeastern US']","['Health coaching', 'health coaching intervention', '10 live coaching sessions delivered virtually by health coaches using the tablets']",['Cost-effectiveness'],"[{'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0264716', 'cui_str': 'Chronic heart failure (disorder)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1272753', 'cui_str': 'Institution'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C2317129', 'cui_str': 'Health coach'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",250.0,0.082201,"If shown to be efficacious and cost-effective, our virtual health coaching intervention can easily be scaled to.","[{'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Riegel', 'Affiliation': 'University of Pennsylvania, United States of America. Electronic address: briegel@nursing.upenn.edu.'}, {'ForeName': 'Alexandra L', 'Initials': 'AL', 'LastName': 'Hanlon', 'Affiliation': 'Virginia Technical University, United States of America.'}, {'ForeName': 'Norma B', 'Initials': 'NB', 'LastName': 'Coe', 'Affiliation': 'University of Pennsylvania, United States of America.'}, {'ForeName': 'Karen B', 'Initials': 'KB', 'LastName': 'Hirschman', 'Affiliation': 'University of Pennsylvania, United States of America.'}, {'ForeName': 'Gladys', 'Initials': 'G', 'LastName': 'Thomas', 'Affiliation': 'University of Pennsylvania, United States of America.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Stawnychy', 'Affiliation': 'University of Pennsylvania, United States of America.'}, {'ForeName': 'Joyce W', 'Initials': 'JW', 'LastName': 'Wald', 'Affiliation': 'Hospital of the University of Pennsylvania, United States of America.'}, {'ForeName': 'Kathryn H', 'Initials': 'KH', 'LastName': 'Bowles', 'Affiliation': 'University of Pennsylvania, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105845']
959,31284175,The impact of psychostimulants on sustained attention over a 24-h period.,"The off-label use of psychostimulants is a growing trend in healthy adults with many turning to these medications to increase alertness, attentional focus, and to help them study. However, the empirical literature on the efficacy of these medications for cognitive enhancement is controversial and the longer-term impact of these drugs on health and cognitive processing has not been thoroughly examined. Specifically, sleep supports daytime alertness, vigilance, and sustained attention, yet stimulants significantly disrupt sleep. Here, using a double-blind, placebo-controlled, crossover design, we tested the impact morning administration of psychostimulants (dextroamphetamine; DEX) had on: (1) tests of attention 75-min and 12-h after drug ingestion, (2) nighttime sleep and (3) post-sleep attention in healthy, young adults. First, we found that repeated testing led to significant decreases in performance from baseline in the placebo condition, and that DEX, compared to placebo, prevented deterioration at the 75-min test, and selectively for visual field at the 12 h and 24 h tests. We also found that stimulants, compared to placebo, benefitted attentional processing 75-min post-drug but this did not persist to the delayed test 12-h after drug administration. Additionally, morning stimulant administration resulted in robust nighttime sleep disruptions, yet post-sleep sustained attention was equivalent in the stimulant and placebo conditions, indicating that the initial boost to performance dissipated at 24 h, but the decrease was not significantly worse than placebo. Together, these results suggest that stimulant medications, commonly used off-label for cognitive enhancement may prevent deterioration of sustained attention brought on by repeated within-day testing. Additionally, these medications substantially disrupt nighttime sleep; which while coming at little cost to next-day attentional processing, may have steeper consequences for other cognitive domains.",2019,"We also found that stimulants, compared to placebo, benefitted attentional processing 75-min post-drug","['healthy, young adults', 'healthy adults']","['attention 75-min and 12-h after drug ingestion, (2) nighttime sleep and (3) post-sleep attention', 'psychostimulants (dextroamphetamine; DEX', 'placebo', 'DEX']","['robust nighttime sleep disruptions', 'nighttime sleep', 'sleep supports daytime alertness, vigilance, and sustained attention']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0304403', 'cui_str': 'Psychostimulant'}, {'cui': 'C0011812', 'cui_str': 'dexamfetamine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332453', 'cui_str': 'Disruption (morphologic abnormality)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}, {'cui': 'C0589099', 'cui_str': 'Sustained attention, function (observable entity)'}]",,0.163138,"We also found that stimulants, compared to placebo, benefitted attentional processing 75-min post-drug","[{'ForeName': 'Lauren N', 'Initials': 'LN', 'LastName': 'Whitehurst', 'Affiliation': 'Department of Psychiatry, University of California, San Francisco, CA, USA. Electronic address: lauren.whitehurst@ucsf.edu.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Agosta', 'Affiliation': 'Center for Neuroscience and Cognitive Systems@UniTn, Istituto Italiano di Tecnologia, Rovereto, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Castaños', 'Affiliation': 'School of Medicine, University of California, Riverside, CA, USA.'}, {'ForeName': 'Lorella', 'Initials': 'L', 'LastName': 'Battelli', 'Affiliation': 'Center for Neuroscience and Cognitive Systems@UniTn, Istituto Italiano di Tecnologia, Rovereto, Italy; Berenson-Allen Center for Noninvasive Brain Stimulation, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Sara C', 'Initials': 'SC', 'LastName': 'Mednick', 'Affiliation': 'Department of Cognitive Science, University of California, Irvine, USA.'}]",Cognition,['10.1016/j.cognition.2019.104015']
960,31413095,A cross-trial comparison of single-agent ibrutinib  versus  chlorambucil-obinutuzumab in previously untreated patients with chronic lymphocytic leukemia or small lymphocytic lymphoma.,,2020,,['previously untreated patients with chronic lymphocytic leukemia or small lymphocytic lymphoma'],['single-agent ibrutinib versus chlorambucil-obinutuzumab'],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023434', 'cui_str': 'Lymphoma, Small Lymphocytic'}, {'cui': 'C0855095', 'cui_str': 'Malignant lymphoma, small lymphocytic (morphologic abnormality)'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C3501358', 'cui_str': 'Ibrutinib'}, {'cui': 'C0008163', 'cui_str': 'Chlorambucil'}, {'cui': 'C2742503', 'cui_str': 'obinutuzumab'}]",[],,0.0264099,,"[{'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Tedeschi', 'Affiliation': 'ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy alessandra.tedeschi@ospedaleniguarda.it.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Greil', 'Affiliation': 'Paracelsus Medical University Salzburg, Salzburg Cancer Research Institute, Cancer Cluster Salzburg, Salzburg, Austria.'}, {'ForeName': 'Fatih', 'Initials': 'F', 'LastName': 'Demirkan', 'Affiliation': 'Dokuz Eylul University, Izmir, Turkey.'}, {'ForeName': 'Tadeusz', 'Initials': 'T', 'LastName': 'Robak', 'Affiliation': 'Medical University of Lodz, Copernicus Memorial Hospital, Lodz, Poland.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Moreno', 'Affiliation': 'Hospital de la Santa Creu i Sant Pau, Autonomous University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Barr', 'Affiliation': 'Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Anz', 'Affiliation': 'Tennessee Oncology, Chattanooga, TN, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Simpson', 'Affiliation': 'North Shore Hospital, Auckland, New Zealand.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Gaidano', 'Affiliation': 'Amedeo Avogadro University of Eastern Piedmont, Novara, Italy.'}, {'ForeName': 'Osnat', 'Initials': 'O', 'LastName': 'Bairey', 'Affiliation': 'Rabin Medical Center, Beilinson Hospital and Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Don', 'Initials': 'D', 'LastName': 'Stevens', 'Affiliation': 'Norton Cancer Institute, Louisville, KY, USA.'}, {'ForeName': 'Devinder', 'Initials': 'D', 'LastName': 'Gill', 'Affiliation': 'Princess Alexandra Hospital, Brisbane, Australia.'}, {'ForeName': 'Ian W', 'Initials': 'IW', 'LastName': 'Flinn', 'Affiliation': 'Sarah Cannon Research Institute/Tennessee Oncology, Nashville, TN, USA.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Kipps', 'Affiliation': 'University of California, San Diego, Moores Cancer Center, La Jolla, CA, USA.'}, {'ForeName': 'Jan A', 'Initials': 'JA', 'LastName': 'Burger', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': 'Pharmacyclics LLC, an AbbVie Company, Sunnyvale, CA, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Webb', 'Affiliation': 'Janssen Ltd, High Wycombe, UK.'}, {'ForeName': 'Viktor', 'Initials': 'V', 'LastName': 'Fedorov', 'Affiliation': 'Pharmacyclics LLC, an AbbVie Company, Sunnyvale, CA, USA.'}, {'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Styles', 'Affiliation': 'Pharmacyclics LLC, an AbbVie Company, Sunnyvale, CA, USA.'}, {'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'Gribben', 'Affiliation': 'Barts Cancer Institute, Queen Mary University of London, London, UK.'}]",Haematologica,['10.3324/haematol.2019.223743']
961,31863465,Beyond the Randomized Clinical Trial: Innovative Data Science to Close the Pediatric Evidence Gap.,"Despite the application of advanced statistical and pharmacometric approaches to pediatric trial data, a large pediatric evidence gap still remains. Here, we discuss how to collect more data from children by using real-world data from electronic health records, mobile applications, wearables, and social media. The large datasets collected with these approaches enable and may demand the use of artificial intelligence and machine learning to allow the data to be analyzed for decision making. Applications of this approach are presented, which include the prediction of future clinical complications, medical image analysis, identification of new pediatric end points and biomarkers, the prediction of treatment nonresponders, and the prediction of placebo-responders for trial enrichment. Finally, we discuss how to bring machine learning from science to pediatric clinical practice. We conclude that advantage should be taken of the current opportunities offered by innovations in data science and machine learning to close the pediatric evidence gap.",2020,"Applications of this approach are presented, which include the prediction of future clinical complications, medical image analysis, identification of new pediatric endpoints and biomarkers, the prediction of treatment non-responders and the prediction of placebo-responders for trial enrichment.",[],[],[],[],[],[],,0.0793074,"Applications of this approach are presented, which include the prediction of future clinical complications, medical image analysis, identification of new pediatric endpoints and biomarkers, the prediction of treatment non-responders and the prediction of placebo-responders for trial enrichment.","[{'ForeName': 'Sebastiaan C', 'Initials': 'SC', 'LastName': 'Goulooze', 'Affiliation': 'Division of Systems Biomedicine and Pharmacology, Leiden Academic Centre for Drug Research, Leiden University, Leiden, The Netherlands.'}, {'ForeName': 'Laura B', 'Initials': 'LB', 'LastName': 'Zwep', 'Affiliation': 'Division of Systems Biomedicine and Pharmacology, Leiden Academic Centre for Drug Research, Leiden University, Leiden, The Netherlands.'}, {'ForeName': 'Julia E', 'Initials': 'JE', 'LastName': 'Vogt', 'Affiliation': 'Medical Data Science Group, Department of Computer Science, ETH Zurich, Zurich, Switzerland.'}, {'ForeName': 'Elke H J', 'Initials': 'EHJ', 'LastName': 'Krekels', 'Affiliation': 'Division of Systems Biomedicine and Pharmacology, Leiden Academic Centre for Drug Research, Leiden University, Leiden, The Netherlands.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hankemeier', 'Affiliation': 'Division of Systems Biomedicine and Pharmacology, Leiden Academic Centre for Drug Research, Leiden University, Leiden, The Netherlands.'}, {'ForeName': 'John N', 'Initials': 'JN', 'LastName': 'van den Anker', 'Affiliation': ""Division of Clinical Pharmacology, Children's National Health System, Washington, District of Columbia, USA.""}, {'ForeName': 'Catherijne A J', 'Initials': 'CAJ', 'LastName': 'Knibbe', 'Affiliation': 'Division of Systems Biomedicine and Pharmacology, Leiden Academic Centre for Drug Research, Leiden University, Leiden, The Netherlands.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.1744']
962,31959002,An Approach to Adapting a Community-Based Cancer Control Intervention to Organizational Context.,"There has been increasing attention in implementation science to optimizing the fit of evidence-based interventions to the organizational settings where they are delivered. However, less is known about how to maximize intervention-context fit, particularly in community-based settings. We describe a new strategy to customize evidence-based health promotion interventions to community sites. Specifically, leaders in African American churches completed a memorandum of understanding where they were asked to identify two or more health promotion implementation strategies from a menu of 20 and select a planned implementation time frame for each. In a pilot phase with three churches, the menu-based strategy and protocols were successfully implemented and finalized in preparation for a subsequent randomized trial. The three pilot churches identified between two and nine strategies (e.g., form a health ministry, allocate space or budget for health activities, include health in church communications/sermons). The selected strategies varied widely, reinforcing the need for interventions that can be customized to fit the organizational context. Despite the challenges of integrating health promotion activities into non-health focused organizations, this approach has promise for fostering sustainable health activities in community settings.",2020,"In a pilot phase with three churches, the menu-based strategy and protocols were successfully implemented and finalized in preparation for a subsequent randomized trial.",['African American churches'],[],[],"[{'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0562324', 'cui_str': 'Church (environment)'}]",[],[],,0.0256686,"In a pilot phase with three churches, the menu-based strategy and protocols were successfully implemented and finalized in preparation for a subsequent randomized trial.","[{'ForeName': 'Cheryl L', 'Initials': 'CL', 'LastName': 'Knott', 'Affiliation': 'University of Maryland, College Park, MD, USA.'}, {'ForeName': 'Janice', 'Initials': 'J', 'LastName': 'Bowie', 'Affiliation': 'Johns Hopkins Bloomberg, Baltimore, MD, USA.'}, {'ForeName': 'C Daniel', 'Initials': 'CD', 'LastName': 'Mullins', 'Affiliation': 'University of Maryland, College Park, MD, USA.'}, {'ForeName': 'Sherie Lou Zara', 'Initials': 'SLZ', 'LastName': 'Santos', 'Affiliation': 'University of Maryland, College Park, MD, USA.'}, {'ForeName': 'Jimmie', 'Initials': 'J', 'LastName': 'Slade', 'Affiliation': ""Community Ministry of Prince George's County, Upper Marlboro, MD, USA.""}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Rosenberg', 'Affiliation': 'University of Maryland, College Park, MD, USA.'}, {'ForeName': 'Nathaniel', 'Initials': 'N', 'LastName': 'Woodard', 'Affiliation': 'University of Maryland, College Park, MD, USA.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Williams', 'Affiliation': 'Access to Wholistic and Productive Living, Inc, Brentwood, MD, USA.'}, {'ForeName': 'Randi M', 'Initials': 'RM', 'LastName': 'Williams', 'Affiliation': 'University of Maryland, College Park, MD, USA.'}]",Health promotion practice,['10.1177/1524839919898209']
963,32054652,Impact of idelalisib on health-related quality of life in patients with relapsed chronic lymphocytic leukemia in a phase 3 randomized trial.,,2020,,['patients with relapsed chronic lymphocytic leukemia'],['idelalisib'],['health-related quality of life'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023434', 'cui_str': 'Lymphoma, Small Lymphocytic'}]","[{'cui': 'C2698692', 'cui_str': 'idelalisib'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}]",,0.0582542,,"[{'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Ghia', 'Affiliation': 'Università Vita-Salute San Raffaele and IRCCS Ospedale San Raffaele, Milano, Italy; ghia.paolo@hsr.it.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Coutre', 'Affiliation': 'Stanford School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Bruce D', 'Initials': 'BD', 'LastName': 'Cheson', 'Affiliation': 'Georgetown University Hospital, Washington D.C., USA.'}, {'ForeName': 'Jacqueline C', 'Initials': 'JC', 'LastName': 'Barrientos', 'Affiliation': 'Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hillmen', 'Affiliation': ""St. James's University Hospital, Leeds, UK.""}, {'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Pettitt', 'Affiliation': 'University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Zelenetz', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Sanatan', 'Initials': 'S', 'LastName': 'Shreay', 'Affiliation': 'Gilead Sciences, Inc, Foster City, CA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hallek', 'Affiliation': 'Dept. I of Internal Medicine, University Hospital of Cologne, Cologne, Germany.'}, {'ForeName': 'Richard R', 'Initials': 'RR', 'LastName': 'Furman', 'Affiliation': 'Weill Cornell Medical College, New York, NY, USA.'}]",Haematologica,['10.3324/haematol.2019.238808']
964,17457295,[2-COM: presentation of an instrument facilitating communication between physicians and carers in daily practice].,"Communication between the patient and the professional carer lies at the heart of all decisions regarding diagnosis and treatment. However, patients and doctors often have divergent views on care needs; 2-COM (for 2-communication) is a simple patient-completed self-report instrument designed in order to facilitate patient-professional carer communication. Aims - To present 2-COM and to examine whether providing patients with an opportunity to identify and discuss their needs would improve communication and induce changes in care. Methods - The 2-COM is a simple list of 20 common problems, or areas of perceived need, that might be experienced by patients with severe mental illness. The list includes problems with housing, relationships, money, lack of activities, psychological distress, sexuality, symptoms and treatment side effects; 2-COM has shown adequate test-retest reliability and is well accepted by patients as a valued aid to communication with their doctor; 134 patients in a clinical diagnosis of schizophrenia or schizoaffective disorder were recruited at seven European centres: Maastricht, Oviedo, Gijon, Hamburg, Copenhagen, Milan and Nice. The assessment took place over 3 out patient clinic visits; at visit 1, the clinician recorded a list of all current interventions, including medication and non-medical treatments, together with demographic information and an assessment of current level of functioning, using the Global Assessment of Functioning scale. Prior to the second visit, patients were randomised to receive either 2-COM or ""standard care"" - a routine appointment without 2-COM. Immediately after the interview, all patients, whether they had completed 2-COM or not, completed a confidential questionnaire in which they could indicate the perceived quality of communication. Similarly, clinicians completed a repeat of the list of all current interventions, together with an assessment of any changes to the treatment plan implemented after the interview with the patient. Four to six weeks after clinic visit 2, patients attended the clinic for a third, ""routine"" clinical interview. Both patients and clinicians then completed the same set of post-interview assessments as at visit 2. The 2-COM induced a stable improvement of patient-reported quality of patient-doctor communication (B=0.33, P=0.031), and induced changes in management immediately after the intervention. Treatment change was more likely in patients with more reported needs at the 2-COM and needs most likely to induce treatment changes. In conclusion, the study showed that 2-COM is a useful instrument to expose and subsequently bridge, patient-professional carer discordance on patient needs.",2007,"The 2-COM induced a stable improvement of patient-reported quality of patient-doctor communication (B=0.33, P=0.031), and induced changes in management immediately after the intervention.","['patients with severe mental illness', 'patients as a valued aid to communication with their doctor; 134 patients in a clinical diagnosis of schizophrenia or schizoaffective disorder', 'physicians and carers in daily practice']","['2-COM or ""standard care"" - a routine appointment without 2-COM', '2-COM']",['quality of patient-doctor communication'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0449435', 'cui_str': 'Aid (attribute)'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C4517565', 'cui_str': 'One hundred and thirty-four'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0036337', 'cui_str': 'Schizoaffective Disorder'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C1305660', 'cui_str': 'Carer (occupation)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}]","[{'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0009452', 'cui_str': 'Communication'}]",,0.0378987,"The 2-COM induced a stable improvement of patient-reported quality of patient-doctor communication (B=0.33, P=0.031), and induced changes in management immediately after the intervention.","[{'ForeName': 'P H', 'Initials': 'PH', 'LastName': 'Robert', 'Affiliation': 'Centre Mémoire de Ressources et de Recherche, CHU Pasteur, Nice, France.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Michel', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Van Os', 'Affiliation': ''}, {'ForeName': 'A C', 'Initials': 'AC', 'LastName': 'Altamura', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bobes', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Gerlach', 'Affiliation': ''}, {'ForeName': 'J S E', 'Initials': 'JS', 'LastName': 'Hellewell', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Kasper', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Nabel', 'Affiliation': ''}]",L'Encephale,[]
965,32429733,Evervac: phase I/II study of immunogenicity and safety of a new adjuvant-free TBE vaccine cultivated in Vero cell culture.,"Approximately 10,000 cases of tick-borne encephalitis (TBE), a serious disease of the central nervous system caused by tick-borne encephalitis virus (TBEV), are registered worldwide every year. Vaccination against TBE remains the most essential measure of preventing the disease. Unlike available TBE vaccines, a new inactivated lyophilized candidate vaccine Evervac is produced in Vero continuous cell culture and its final formulation does not include aluminum-based adjuvants. To study the safety and immunogenicity of Evervac, healthy adults 18-60 y of age were immunized twice at 30-d intervals. The study was single-blind, randomized, comparative, controlled, and was conducted in TBE-endemic areas. The commercial lyophilized vaccine TBE-Moscow was used as a comparison treatment. The subjects were observed for incidence, severity, and duration of adverse reactions. It was shown that the severity of local and systemic reactions in the Evervac vaccine group was mild to moderate. There were no significant differences in the incidence of adverse reactions between the Evervac and TBE-Moscow vaccine groups. Immunization with Evervac produced a significant increase in geometric mean titer (GMT) of anti-TBEV antibodies in both initially seronegative and seropositive recipients. The seroconversion rate for the initially seronegative recipients was 69% (GMT = 1:214) after the first dose and reached 100% after the second dose. In these parameters, there were no significant differences between the study and control vaccine groups. Thus, the adjuvant-free Vero-based vaccine Evervac was well tolerated, had low reactogenicity, induced a pronounced immune response, and was overall non-inferior to the commercial adjuvanted TBE vaccine used as a control.",2020,Immunization with Evervac produced a significant increase in geometric mean titer (GMT) of anti-TBEV antibodies in both initially seronegative and seropositive recipients.,"['healthy adults 18-60\xa0y of age were immunized twice at 30-d intervals', 'Vero cell culture']",['new adjuvant-free TBE vaccine cultivated'],"['incidence, severity, and duration of adverse reactions', 'seroconversion rate', 'severity of local and systemic reactions', 'incidence of adverse reactions', 'geometric mean titer (GMT) of anti-TBEV antibodies']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0042542', 'cui_str': 'Vero Cells'}, {'cui': 'C0010453', 'cui_str': 'Culture'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0593408', 'cui_str': 'Tick-borne encephalitis vaccine'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0040203', 'cui_str': 'Ixodida'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0014051', 'cui_str': 'Encephalitis Virus'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}]",,0.0161945,Immunization with Evervac produced a significant increase in geometric mean titer (GMT) of anti-TBEV antibodies in both initially seronegative and seropositive recipients.,"[{'ForeName': 'Mikhail F', 'Initials': 'MF', 'LastName': 'Vorovitch', 'Affiliation': 'TBE Vaccine Department, Federal State Budgetary Scientific Institution ""Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products of Russian Academy of Sciences"" (FSBSI ""Chumakov FSC R&D IBP RAS"") , Moscow, Russia.'}, {'ForeName': 'Karina G', 'Initials': 'KG', 'LastName': 'Grishina', 'Affiliation': 'TBE Vaccine Department, Federal State Budgetary Scientific Institution ""Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products of Russian Academy of Sciences"" (FSBSI ""Chumakov FSC R&D IBP RAS"") , Moscow, Russia.'}, {'ForeName': 'Viktor P', 'Initials': 'VP', 'LastName': 'Volok', 'Affiliation': 'Laboratory of Biology of Arboviruses, Federal State Budgetary Scientific Institution ""Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products of Russian Academy of Sciences"" (FSBSI ""Chumakov FSC R&D IBP RAS"") , Moscow, Russia.'}, {'ForeName': 'Liubov L', 'Initials': 'LL', 'LastName': 'Chernokhaeva', 'Affiliation': 'TBE Vaccine Department, Federal State Budgetary Scientific Institution ""Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products of Russian Academy of Sciences"" (FSBSI ""Chumakov FSC R&D IBP RAS"") , Moscow, Russia.'}, {'ForeName': 'Konstantin V', 'Initials': 'KV', 'LastName': 'Grishin', 'Affiliation': 'TBE Vaccine Department, Federal State Budgetary Scientific Institution ""Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products of Russian Academy of Sciences"" (FSBSI ""Chumakov FSC R&D IBP RAS"") , Moscow, Russia.'}, {'ForeName': 'Galina G', 'Initials': 'GG', 'LastName': 'Karganova', 'Affiliation': 'Laboratory of Biology of Arboviruses, Federal State Budgetary Scientific Institution ""Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products of Russian Academy of Sciences"" (FSBSI ""Chumakov FSC R&D IBP RAS"") , Moscow, Russia.'}, {'ForeName': 'Aidar A', 'Initials': 'AA', 'LastName': 'Ishmukhametov', 'Affiliation': 'Federal State Budgetary Scientific Institution ""Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products of Russian Academy of Sciences"" (FSBSI ""Chumakov FSC R&D IBP RAS"") , Moscow, Russia.'}]",Human vaccines & immunotherapeutics,['10.1080/21645515.2020.1757990']
966,32434574,Mismatch between self-perceived and calculated cardiometabolic disease risk among participants in a prevention program for cardiometabolic disease: a cross-sectional study.,"BACKGROUND


The rising prevalence of cardiometabolic diseases (CMD) calls for effective prevention programs. Self-assessment of CMD risk, for example through an online risk score (ORS), might induce risk reducing behavior. However, the concept of disease risk is often difficult for people to understand. Therefore, the study objective was to assess the impact of communicating an individualized CMD risk score through an ORS on perceived risk and to identify risk factors and demographic characteristics associated with risk perception among high-risk participants of a prevention program for CMD.
METHODS


A cross-sectional analysis of baseline data from a randomized controlled trial conducted in a primary care setting. Seven thousand five hundred forty-seven individuals aged 45-70 years without recorded CMD, hypertension or hypercholesterolemia participated. The main outcome measures were: 1) differences in cognitive and affective risk perception between the intervention group - who used an ORS and received an individualized CMD risk score- and the control group who answered questions about CMD risk, but did not receive an individualized CMD risk score; 2) risk factors and demographic characteristics associated with risk perception.
RESULTS


No differences were found in cognitive and affective risk perception between the intervention and control group and risk perception was on average low, even among high-risk participants. A positive family history for diabetes type 2 (β0.56, CI95% 0.39-0.73) and cardiovascular disease (β0.28, CI95% 0.13-0.43), BMI ≥25 (β0.27, CI95% 0.12-0.43), high waist circumference (β0.25, CI95% 0.02-0.48) and physical inactivity (β0.30, CI95% 0.16-0.45) were positively associated with cognitive CMD risk perception in high-risk participants. No other risk factors or demographic characteristics were associated with risk perception.
CONCLUSIONS


Communicating an individualized CMD risk score did not affect risk perception. A mismatch was found between calculated risk and self-perceived risk in high-risk participants. Family history and BMI seem to affect the level of CMD risk perception more than risk factors such as sex, age and smoking. A dialogue about personal CMD risk between patients and health care professionals might optimize the effect of the provided risk information.
TRIAL REGISTRATION


Dutch trial Register number NTR4277, registered 26th Nov 2013.",2020,"No differences were found in cognitive and affective risk perception between the intervention and control group and risk perception was on average low, even among high-risk participants.","['Seven thousand five hundred forty-seven individuals aged 45-70\u2009years without recorded CMD, hypertension or hypercholesterolemia participated', 'participants in a prevention program for cardiometabolic disease', 'high-risk participants of a prevention program for CMD']",[],"['high waist circumference', 'risk perception', 'cardiovascular disease', 'level of CMD risk perception', 'cognitive CMD risk perception', 'physical inactivity', 'cognitive and affective risk perception']","[{'cui': 'C4517869', 'cui_str': '7500'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0020443', 'cui_str': 'Hypercholesterolemia'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}]",[],"[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1281905', 'cui_str': 'At risk of disease'}, {'cui': 'C3890554', 'cui_str': 'Physical Inactivity'}]",7547.0,0.0357281,"No differences were found in cognitive and affective risk perception between the intervention and control group and risk perception was on average low, even among high-risk participants.","[{'ForeName': 'D M', 'Initials': 'DM', 'LastName': 'Stol', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, P.O. Box 85500, 3508, GA, Utrecht, the Netherlands. d.m.stol@umcutrecht.nl.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hollander', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, P.O. Box 85500, 3508, GA, Utrecht, the Netherlands.'}, {'ForeName': 'O C', 'Initials': 'OC', 'LastName': 'Damman', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Public and Occupational Health, Amsterdam Public Health research institute, Amsterdam, the Netherlands.'}, {'ForeName': 'M M J', 'Initials': 'MMJ', 'LastName': 'Nielen', 'Affiliation': 'Netherlands Institute for Health Services Research (NIVEL), Utrecht, the Netherlands.'}, {'ForeName': 'I F', 'Initials': 'IF', 'LastName': 'Badenbroek', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, P.O. Box 85500, 3508, GA, Utrecht, the Netherlands.'}, {'ForeName': 'F G', 'Initials': 'FG', 'LastName': 'Schellevis', 'Affiliation': 'Netherlands Institute for Health Services Research (NIVEL), Utrecht, the Netherlands.'}, {'ForeName': 'N J', 'Initials': 'NJ', 'LastName': 'de Wit', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, P.O. Box 85500, 3508, GA, Utrecht, the Netherlands.'}]",BMC public health,['10.1186/s12889-020-08906-z']
967,32434492,Loneliness as a predictor of outcomes in mental disorders among people who have experienced a mental health crisis: a 4-month prospective study.,"BACKGROUND


Loneliness has not until recently been a prominent focus in research on outcomes of mental illness. The aim of this study was to determine whether loneliness at baseline predicts poor outcomes at 4-month follow-up for individuals who have experienced mental health crises. The outcomes in this study included overall symptom severity, affective symptoms, self-rated recovery and health-related quality of life.
METHODS


Our study reports a secondary analysis of data from a randomised controlled trial. The sample (n = 399) was taken from patients who received treatment from community crisis services. Respondents (n = 310) completed the follow-up measurement 4 months after baseline. Loneliness at baseline was assessed using an eight-item UCLA Loneliness Scale. The four mental health outcomes were measured at both baseline and follow-up. Two scales (or part thereof) assessed objective social isolation and neighbourhood social capital at baseline. Regression analyses were conducted to investigate longitudinal associations between loneliness at baseline and mental health outcomes at follow-up.
RESULTS


Loneliness at baseline was associated with all four mental health outcomes at 4-month follow-up, adjusting for psychosocial, socio-demographic and clinical characteristics. A one-point higher loneliness score was associated with 0.74-point (95% CI 0.45, 1.02) and 0.34-point (95% CI 0.21, 0.47) increase in overall symptom severity score and affective symptoms score respectively, and with 1.08-point (95% CI -1.45, - 0.71) and 1.27-point (95% CI -1.79, - 0.75) decrease in self-rated recovery score and health-related quality of life score respectively. Loneliness was a better predictor of clinical outcomes than objective social isolation and social capital, even though the associations with clinical outcomes were reduced and no longer statistically significant following adjustment for their baseline values. A significant association with quality of life persisted after adjustment for its baseline score.
CONCLUSIONS


Greater loneliness at baseline predicted poorer health-related quality of life at follow-up. There were cross-sectional associations between loneliness and clinical outcomes, but their longitudinal relationship cannot be confirmed. Further research is needed to clearly establish their underpinning pathways. Reducing loneliness may be a promising target to improve recovery for mental health community crisis service users.",2020,"A one-point higher loneliness score was associated with 0.74-point (95% CI 0.45, 1.02) and 0.34-point (95% CI 0.21, 0.47) increase in overall symptom severity score and affective symptoms score respectively, and with 1.08-point (95% CI -1.45, - 0.71) and 1.27-point (95% CI -1.79, - 0.75) decrease in self-rated recovery score and health-related quality of life score respectively.","['people who have experienced a mental health crisis', 'individuals who have experienced mental health crises', 'mental health community crisis service users']",[],"['quality of life', 'self-rated recovery score and health-related quality of life score', 'overall symptom severity, affective symptoms, self-rated recovery and health-related quality of life', 'health-related quality of life', 'overall symptom severity score and affective symptoms score', 'loneliness score', 'objective social isolation and neighbourhood social capital']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0231224', 'cui_str': 'Crisis'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0557854', 'cui_str': 'Services'}]",[],"[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0001726', 'cui_str': 'Affective Symptoms'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0037421', 'cui_str': 'Social isolation'}, {'cui': 'C1510639', 'cui_str': 'Social Capital'}]",,0.216986,"A one-point higher loneliness score was associated with 0.74-point (95% CI 0.45, 1.02) and 0.34-point (95% CI 0.21, 0.47) increase in overall symptom severity score and affective symptoms score respectively, and with 1.08-point (95% CI -1.45, - 0.71) and 1.27-point (95% CI -1.79, - 0.75) decrease in self-rated recovery score and health-related quality of life score respectively.","[{'ForeName': 'Jingyi', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Division of Psychiatry, University College London, Maple House, 149 Tottenham Court Road, London, W1T 7NF, UK. jingyi.wang.13@ucl.ac.uk.'}, {'ForeName': 'Brynmor', 'Initials': 'B', 'LastName': 'Lloyd-Evans', 'Affiliation': 'Division of Psychiatry, University College London, Maple House, 149 Tottenham Court Road, London, W1T 7NF, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Marston', 'Affiliation': 'Research Department of Primary Care and Population Health, University College London, UCL Medical School, Rowland Hill Street, London, NW3 2PF, UK.'}, {'ForeName': 'Farhana', 'Initials': 'F', 'LastName': 'Mann', 'Affiliation': 'Division of Psychiatry, University College London, Maple House, 149 Tottenham Court Road, London, W1T 7NF, UK.'}, {'ForeName': 'Ruimin', 'Initials': 'R', 'LastName': 'Ma', 'Affiliation': 'Division of Psychiatry, University College London, Maple House, 149 Tottenham Court Road, London, W1T 7NF, UK.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Johnson', 'Affiliation': 'Division of Psychiatry, University College London, Maple House, 149 Tottenham Court Road, London, W1T 7NF, UK. s.johnson@ucl.ac.uk.'}]",BMC psychiatry,['10.1186/s12888-020-02665-2']
968,32434504,Implementation of an interactive organ donation education program for Dutch lower-educated students: a process evaluation.,"BACKGROUND


As organ donation registration rates remain low, especially among lower-educated people, it is important to support this group in making their registration decision. To prepare lower-educated students in the Netherlands for making a well-informed decision, an interactive educational program was developed. We aim to understand both the (quality of) implementation as well as to contextualize the effects of this program in a lower-educated school setting.
METHODS


The process evaluation was part of a Cluster Randomized Controlled Trial, in which 11 schools for Intermediate Vocational Education throughout the Netherlands participated. Teachers who taught a course on Citizenship delivered three intervention elements (i.e. video fragments and discussion, quizzes with tailored feedback and an exercise filling out a registration form) to their students. Implementation was assessed by interviews with teachers, questionnaires from students, logbooks from teachers and user data from Google Analytics.
RESULTS


The program was well received and implemented, but on-the-spot adaptations were made by teachers to fit their students better. Within the lower-educated target group, differences between students are high in terms of active participation, reading abilities, knowledge and attention span. The program fit well within their regular teaching activities, but the topic of organ donation is not always prioritized by teachers.
CONCLUSIONS


We see opportunities to disseminate the program on a larger scale and reach a group that has been neglected in organ donation education before. Within the program, there are possibilities to increase the effectiveness of the program, such as alternative delivery methods for the elements with a lot of text, the addition of booster sessions and guidelines for teachers to adapt the program to students of different levels within Intermediate Vocational Education. Moreover, in order to have an impact on a national level, strategies need to be employed to reach high numbers of students and, therefore, support on a higher level is needed (both within schools and at policy level).
TRIAL REGISTRATION


Dutch Trial Register, NTR6771. Prospectively registered on 24 October 2017.",2020,"Within the lower-educated target group, differences between students are high in terms of active participation, reading abilities, knowledge and attention span.","['11 schools for Intermediate Vocational Education throughout the Netherlands participated', 'Dutch lower-educated students', 'Prospectively registered on 24 October 2017']",['interactive organ donation education program'],"['active participation, reading abilities, knowledge and attention span']","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0042933', 'cui_str': 'Vocational schooling'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0600375', 'cui_str': 'Registers'}]","[{'cui': 'C0029216', 'cui_str': 'Organ transplant'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.0367916,"Within the lower-educated target group, differences between students are high in terms of active participation, reading abilities, knowledge and attention span.","[{'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Steenaart', 'Affiliation': 'Department of Health Promotion, CAPHRI Maastricht University, P.O. Box 616, 6200 MD, Maastricht, The Netherlands. e.steenaart@maastrichtuniversity.nl.'}, {'ForeName': 'Rik', 'Initials': 'R', 'LastName': 'Crutzen', 'Affiliation': 'Department of Health Promotion, CAPHRI Maastricht University, P.O. Box 616, 6200 MD, Maastricht, The Netherlands.'}, {'ForeName': 'Nanne K', 'Initials': 'NK', 'LastName': 'de Vries', 'Affiliation': 'Department of Health Promotion, CAPHRI Maastricht University, P.O. Box 616, 6200 MD, Maastricht, The Netherlands.'}]",BMC public health,['10.1186/s12889-020-08900-5']
969,32017250,Does patient expectancy account for the cognitive and clinical benefits of mindfulness training in older adults?,"OBJECTIVES


Patient expectations of treatment effects could influence neuropsychological and clinical outcomes in clinical trials of behavioral and lifestyle interventions, which could potentially confound the interpretation of findings. Our aim was to examine whether patient expectancy mediated effectiveness of Mindfulness-Based Stress Reduction (MBSR) for improving cognitive function and clinical outcome.
METHODS


The present study uses data from a single-blind, multi-site, randomized controlled trial comparing MBSR to a health education attention control in older adults with anxiety and/or depressive disorders and subjective cognitive concerns. Using the Credibility and Expectations Questionnaire, we measured expectancy and perceived credibility of the interventions assigned to patients. Using mediational analysis, we examined the influence of expectancy and credibility on two key outcomes: memory performance and clinical global improvement.
RESULTS


Neither expectancy nor perceived credibility of intervention accounted significantly for MBSR's effectiveness for memory test performance or clinical global improvement.
CONCLUSION


In this clinical trial, expectancy for improvement did not account for the effectiveness of MBSR on memory performance or clinical outcomes in depressed and anxious older adults. We advise that clinical trials of behavioral and lifestyle interventions for brain health in older adults should measure and test the role of expectancy.",2020,"Neither expectancy nor perceived credibility of intervention accounted significantly for MBSR's effectiveness for memory test performance or clinical global improvement.
","['older adults', 'depressed and anxious older adults', 'older adults with anxiety and/or depressive disorders and subjective cognitive concerns']","['behavioral and lifestyle interventions', 'mindfulness training', 'Mindfulness Based Stress Reduction (MBSR) to a health education attention control', 'MBSR', 'Mindfulness Based Stress Reduction']",['Credibility and Expectations Questionnaire (CEQ'],"[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}]","[{'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0018701'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.056748,"Neither expectancy nor perceived credibility of intervention accounted significantly for MBSR's effectiveness for memory test performance or clinical global improvement.
","[{'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Haddad', 'Affiliation': 'Department of Psychiatry, Healthy Mind Lab, Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Lenze', 'Affiliation': 'Department of Psychiatry, Healthy Mind Lab, Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Ginger', 'Initials': 'G', 'LastName': 'Nicol', 'Affiliation': 'Department of Psychiatry, Healthy Mind Lab, Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'J Philip', 'Initials': 'JP', 'LastName': 'Miller', 'Affiliation': 'Division of Biostatistics, Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Yingling', 'Affiliation': 'Department of Psychiatry, Healthy Mind Lab, Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Julie Loebach', 'Initials': 'JL', 'LastName': 'Wetherell', 'Affiliation': 'Department of Psychiatry, University of California San Diego, San Diego, CA, USA.'}]",International journal of geriatric psychiatry,['10.1002/gps.5279']
970,32193071,Effects of Senior Simulation Suit Programme on nursing students' attitudes towards older adults: A randomized controlled trial.,"BACKGROUND


As populations age worldwide, nursing educational institutions need to train nurses not only to provide health care services specific to the elderly, but also to have a positive attitude as they work. The present study aimed to investigate the efficacy of a Senior Simulation Suit Programme (SSSP). The SSSP, which focused on mimicking the physiological experiences of an 80 year-old person, was hypothesized to increase the wearer's positive attitude towards older adult care.
METHODS


A single-blinded, randomized controlled trial was used to evaluate the efficacies of SSSP. One hundred and thirty-nine (139) nursing students were randomly assigned to either SSSP group (n = 69) or to a control group (n = 70) with ""placebo clothing"", i.e. clothing that mimicked old age but did not actually impair faculties. Two instruments-Kogan Attitudes Towards Old People Scale (KAOP) and a 1-item scale on Willingness To Care for Older People Scale (WCOP)-were used for data collection at baseline and at completion of SSSP. A Chinese version of Palmore's Facts Aging Quiz (C-FAQ) was used to assess nursing students' knowledge about adult care, and a questionnaire was developed to collect demographic information at baseline.
RESULTS


No significant difference between the two groups was found. A significant increase of positive attitudes and of willingness to serve older adults was found in both the control group and the group wearing SSSP.
CONCLUSION


Both the SSSP and control intervention could improve the attitudes of nursing students towards older adult care. This study suggests that wearing whatever the nursing students associate with being old, will improve their attitude towards older adult care.",2020,"A significant increase of positive attitudes and of willingness to serve older adults was found in both the control group and the group wearing SSSP.
","[""nursing students' attitudes towards older adults"", 'One hundred and thirty-nine (139) nursing students']","['SSSP and control intervention', 'SSSP', 'control group (n\xa0=\xa070) with ""placebo clothing"", i.e. clothing that mimicked old age but did not actually impair faculties', 'Senior Simulation Suit Programme (SSSP', 'WCOP)-were', 'Senior Simulation Suit Programme']",['positive attitudes and of willingness to serve older adults'],"[{'cui': 'C0038496', 'cui_str': 'Pupil Nurses'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0009072', 'cui_str': 'Garments'}, {'cui': 'C1999167', 'cui_str': 'Old-age (finding)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0221099', 'cui_str': 'Impaired (qualifier value)'}, {'cui': 'C0015535', 'cui_str': 'Faculty'}]","[{'cui': 'C0237428', 'cui_str': 'Optimism'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]",,0.0529407,"A significant increase of positive attitudes and of willingness to serve older adults was found in both the control group and the group wearing SSSP.
","[{'ForeName': 'Winnie Lai-Sheung', 'Initials': 'WL', 'LastName': 'Cheng', 'Affiliation': 'School of Nursing, Tung Wah College, Hong Kong. Electronic address: winniecheng@twc.edu.hk.'}, {'ForeName': 'P K', 'Initials': 'PK', 'LastName': 'Ma', 'Affiliation': 'Hospital Authority, Hong Kong.'}, {'ForeName': 'Y Y', 'Initials': 'YY', 'LastName': 'Lam', 'Affiliation': 'Hospital Authority, Hong Kong.'}, {'ForeName': 'K C', 'Initials': 'KC', 'LastName': 'Ng', 'Affiliation': 'Hospital Authority, Hong Kong.'}, {'ForeName': 'T K', 'Initials': 'TK', 'LastName': 'Ling', 'Affiliation': 'Hospital Authority, Hong Kong.'}, {'ForeName': 'W H', 'Initials': 'WH', 'LastName': 'Yau', 'Affiliation': 'Hospital Authority, Hong Kong.'}, {'ForeName': 'Y W', 'Initials': 'YW', 'LastName': 'Chui', 'Affiliation': 'Hospital Authority, Hong Kong.'}, {'ForeName': 'H M', 'Initials': 'HM', 'LastName': 'Tsui', 'Affiliation': 'Hospital Authority, Hong Kong.'}, {'ForeName': 'P P', 'Initials': 'PP', 'LastName': 'Li', 'Affiliation': 'Hospital Authority, Hong Kong.'}]",Nurse education today,['10.1016/j.nedt.2020.104330']
971,28988765,Results of a Phase 1/2 Study in Metastatic Renal Cell Carcinoma Patients Treated with a Patient-specific Adjuvant Multi-peptide Vaccine after Resection of Metastases.,"Treatment of metastatic renal cell carcinoma comprises metastasectomy±systemic medical treatment. Specific immunotherapy after metastasectomy could be a complementary option. In this phase 1/2 study, safety and tolerability of an adjuvant multi-peptide vaccine (UroRCC) after metastasectomy was evaluated together with immune response and efficacy, compared with a contemporary cohort of patients (n=44) treated with metastasectomy only. Nineteen metastatic renal cell carcinoma patients received UroRCC via intradermal or subcutaneous application randomized to immunoadjuvants (granulocyte-macrophage colony-stimulating factor or Montanide). Adverse events of UroRCC were mainly grade I and II; frequency of immune response was higher for major histocompatibility complex class II peptides (17/19, 89.5%) than for major histocompatibility complex class I peptides (8/19, 42.1%). Median overall survival was not reached in the UroRCC group (mean: 112.6 mo, 95% confidence interval [CI]: 92.1-133.1) and 58.0 mo (95% CI: 32.7-83.2) in the control cohort (p=0.015). UroRCC was an independent prognosticator of overall survival (hazard ratio=0.19, 95% CI: 0.05-0.69, p=0.012). Adjuvant UroRCC multi-peptide vaccine after metastasectomy was well tolerated, immunogenic, and indicates potential clinical benefit when compared with a contemporary control cohort (NCT02429440). PATIENT SUMMARY: The application of a patient-specific peptide vaccine after complete resection of metastases in metastatic renal cell carcinoma patients resulted in favorable tolerability and outcome.",2019,"Adverse events of UroRCC were mainly grade I and II; frequency of immune response was higher for major histocompatibility complex class II peptides (17/19, 89.5%) than for major histocompatibility complex class I peptides (8/19, 42.1%).","['metastatic renal cell carcinoma', 'Metastatic Renal Cell Carcinoma Patients Treated with a Patient-specific Adjuvant Multi-peptide Vaccine after Resection of Metastases', 'Nineteen metastatic renal cell carcinoma patients', 'metastatic renal cell carcinoma patients', 'patients (n=44) treated with metastasectomy only']","['UroRCC', 'UroRCC via intradermal or subcutaneous application randomized to immunoadjuvants (granulocyte-macrophage colony-stimulating factor or Montanide', 'adjuvant multi-peptide vaccine (UroRCC', 'patient-specific peptide vaccine']","['frequency of immune response', 'Median overall survival', 'safety and tolerability', 'overall survival']","[{'cui': 'C0278678', 'cui_str': 'Metastatic renal cell carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0599934', 'cui_str': 'Vaccines, Peptide'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0450337', 'cui_str': '19 (qualifier value)'}, {'cui': 'C2363923', 'cui_str': 'Metastasectomy'}]","[{'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0001551', 'cui_str': 'Immunoactivators'}, {'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C0024432', 'cui_str': 'Monocyte-Derived Macrophages'}, {'cui': 'C0439158', 'cui_str': 'colonies (qualifier value)'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0599934', 'cui_str': 'Vaccines, Peptide'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205369', 'cui_str': 'Specified'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0301872', 'cui_str': 'Immune response, function (observable entity)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.175504,"Adverse events of UroRCC were mainly grade I and II; frequency of immune response was higher for major histocompatibility complex class II peptides (17/19, 89.5%) than for major histocompatibility complex class I peptides (8/19, 42.1%).","[{'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Rausch', 'Affiliation': 'Department of Urology, Eberhard Karls University, Tübingen, Germany.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Gouttefangeas', 'Affiliation': 'Department of Immunology, Eberhard Karls University, Tübingen, Germany; German Cancer Consortium (DKTK), Partnerstandort Tübingen, German Cancer Research Center (DKFZ), Heidelberg, Germany.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Hennenlotter', 'Affiliation': 'Department of Urology, Eberhard Karls University, Tübingen, Germany; German Cancer Consortium (DKTK), Partnerstandort Tübingen, German Cancer Research Center (DKFZ), Heidelberg, Germany.'}, {'ForeName': 'Karoline', 'Initials': 'K', 'LastName': 'Laske', 'Affiliation': 'Department of Immunology, Eberhard Karls University, Tübingen, Germany.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Walter', 'Affiliation': 'Department of Urology, Eberhard Karls University, Tübingen, Germany.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Feyerabend', 'Affiliation': 'Department of Urology, Eberhard Karls University, Tübingen, Germany.'}, {'ForeName': 'Premachandran Anoop', 'Initials': 'PA', 'LastName': 'Chandran', 'Affiliation': 'Department of Immunology, Eberhard Karls University, Tübingen, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Kruck', 'Affiliation': 'Department of Urology, Eberhard Karls University, Tübingen, Germany.'}, {'ForeName': 'Harpreet', 'Initials': 'H', 'LastName': 'Singh-Jasuja', 'Affiliation': 'Department of Immunology, Eberhard Karls University, Tübingen, Germany.'}, {'ForeName': 'Annemarie', 'Initials': 'A', 'LastName': 'Frick', 'Affiliation': 'Department of Immunology, Eberhard Karls University, Tübingen, Germany.'}, {'ForeName': 'Nils', 'Initials': 'N', 'LastName': 'Kröger', 'Affiliation': 'Department of Urology, University of Greifswald, Greifswald, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Stevanović', 'Affiliation': 'Department of Immunology, Eberhard Karls University, Tübingen, Germany; German Cancer Consortium (DKTK), Partnerstandort Tübingen, German Cancer Research Center (DKFZ), Heidelberg, Germany.'}, {'ForeName': 'Arnulf', 'Initials': 'A', 'LastName': 'Stenzl', 'Affiliation': 'Department of Urology, Eberhard Karls University, Tübingen, Germany; German Cancer Consortium (DKTK), Partnerstandort Tübingen, German Cancer Research Center (DKFZ), Heidelberg, Germany.'}, {'ForeName': 'Hans-Georg', 'Initials': 'HG', 'LastName': 'Rammensee', 'Affiliation': 'Department of Immunology, Eberhard Karls University, Tübingen, Germany; German Cancer Consortium (DKTK), Partnerstandort Tübingen, German Cancer Research Center (DKFZ), Heidelberg, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Bedke', 'Affiliation': 'Department of Urology, Eberhard Karls University, Tübingen, Germany; German Cancer Consortium (DKTK), Partnerstandort Tübingen, German Cancer Research Center (DKFZ), Heidelberg, Germany. Electronic address: jens.bedke@med.uni-tuebingen.de.'}]",European urology focus,['10.1016/j.euf.2017.09.009']
972,31512716,Sevoflurane- and propofol-based regimens show comparable effect on oxygenation in patients undergoing cardiac valve replacement with cardiopulmonary bypass.,"BACKGROUND


Our study aimed to compare the effects of Sevoflurane- and propofol-based anaesthetic regimens on oxygenation during the early period of cardiopulmonary bypass (CPB) in patients undergoing cardiac valve-replacement surgery.
METHODS


Patients undergoing mechanical mitral, aortic or double valve replacement were enrolled and randomly divided into two groups: the sevoflurane-based anaesthetic regimen group consisted of patients who received 1-3% sevoflurane inhalation during anaesthesia maintenance and the propofol-based anaesthetic regimen group consisted of patients who received 6-10 mg/kg/h of propofol infusion during anaesthesia maintenance. The partial pressure of oxygen/fraction of inspired oxygen (PaO 2 /FiO 2 ), respiratory mechanics and haemodynamics were recorded during CPB.
RESULTS


Forty-two patients met the eligibility criteria for the study. The groups did not differ in terms of clinical and demographic characteristics, and pre- and intra-operative features. Changes in oxygenation were mild (mean PaO 2 /FiO 2  from 358 ± 82 to 471 ± 106 mmHg) within one hour of CPB in our patients. There were no differences in PaO 2 /FiO 2 , respiratory mechanics and haemodynamics between the sevoflurane and propofol groups.
CONCLUSIONS


In patients undergoing cardiac valve replacement with CPB, lung injury was mild, and sevoflurane- and propofol-based anaesthetic regimens showed similar effect on oxygenation, respiratory mechanics and haemodynamics during the early stage of CPB.",2020,Changes in oxygenation were mild (mean PaO 2 /FiO 2  from 358 ± 82 to 471 ± 106 mmHg) within one hour of CPB in our patients.,"['Forty-two patients met the eligibility criteria for the study', 'patients undergoing cardiac valve-replacement surgery', 'Patients undergoing mechanical mitral, aortic or double valve replacement', 'patients undergoing cardiac valve replacement with cardiopulmonary bypass', 'patients undergoing cardiac valve replacement with CPB, lung injury']","['cardiopulmonary bypass (CPB', 'Sevoflurane- and propofol', 'propofol-based anaesthetic regimen group consisted of patients who received 6-10 mg/kg/h of propofol infusion', 'sevoflurane-based anaesthetic regimen group consisted of patients who received 1-3% sevoflurane inhalation', 'sevoflurane', 'Sevoflurane- and propofol-based anaesthetic regimens']","['clinical and demographic characteristics, and pre- and intra-operative features', 'oxygenation, respiratory mechanics and haemodynamics', 'partial pressure of oxygen/fraction of inspired oxygen (PaO 2 /FiO 2 ), respiratory mechanics and haemodynamics', 'PaO 2 /FiO 2 , respiratory mechanics and haemodynamics']","[{'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0018826', 'cui_str': 'Cardiac Valves'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0003483', 'cui_str': 'Aorta'}, {'cui': 'C0190170', 'cui_str': 'Double valve replacement (procedure)'}, {'cui': 'C0007202', 'cui_str': 'Heart-Lung Bypass'}, {'cui': 'C0273115', 'cui_str': 'Pulmonary Injury'}]","[{'cui': 'C0007202', 'cui_str': 'Heart-Lung Bypass'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0002932', 'cui_str': 'Anesthetic Drugs'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C1705211', 'cui_str': 'Inhalation - unit of product usage'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0035230', 'cui_str': 'Breathing Mechanics'}, {'cui': 'C0030604', 'cui_str': 'Partial Pressure'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0428167', 'cui_str': 'FIO2'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output (observable entity)'}]",42.0,0.0543182,Changes in oxygenation were mild (mean PaO 2 /FiO 2  from 358 ± 82 to 471 ± 106 mmHg) within one hour of CPB in our patients.,"[{'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Luo', 'Affiliation': 'Department of Anaesthesiology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Xiaozhen', 'Initials': 'X', 'LastName': 'Wei', 'Affiliation': 'Department of Anaesthesiology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Yunxia', 'Initials': 'Y', 'LastName': 'Zuo', 'Affiliation': 'Department of Anaesthesiology, West China Hospital, Sichuan University, Chengdu, China. Email: 769574913@qq.com.'}, {'ForeName': 'Guizhi', 'Initials': 'G', 'LastName': 'Du', 'Affiliation': 'Department of Anaesthesiology, West China Hospital, Sichuan University, Chengdu, China. Email: du_guizhi@yahoo.com.'}]",Cardiovascular journal of Africa,['10.5830/CVJA-2019-050']
973,31492152,Mycophenolate mofetil and tacrolimus versus tacrolimus alone for the treatment of idiopathic membranous glomerulonephritis: a randomised controlled trial.,"BACKGROUND


Tacrolimus (TAC) is effective in treating membranous nephropathy (MN); however relapses are frequent after treatment cessation. We conducted a randomised controlled trial to examine whether the addition of mycophenolate mofetil (MMF) to TAC would reduce relapse rate.
METHODS


Forty patients with biopsy proven idiopathic MN and nephrotic syndrome were randomly assigned to receive either TAC monotherapy (n = 20) or TAC combined with MMF (n = 20) for 12 months. When patients had been in remission for 1 year on treatment the MMF was stopped and the TAC gradually withdrawn in both groups over 6 months. Patients also received supportive treatment with angiotensin blockade, statins, diuretics and anticoagulation as needed. Primary endpoint was relapse rate following treatment withdrawal. Secondary outcomes were remission rate, time to remission and change in renal function.
RESULTS


16/20 (80%) of patients in the TAC group achieved remission compared to 19/20 (95%) in the TAC/MMF group (p = 0.34). The median time to remission in the TAC group was 54 weeks compared to 40 weeks in the TAC/MMF group (p = 0.46). There was no difference in the relapse rate between the groups: 8/16 (50%) patients in the TAC group relapsed compared to 8/19 (42%) in the TAC/MMF group (p = 0.7). The addition of MMF to TAC did not adversely affect the safety of the treatment.
CONCLUSIONS


Addition of MMF to TAC does not alter the relapse rate of nephrotic syndrome in patients with MN.
TRIAL REGISTRATION


This trial is registered with EudraCTN2008-001009-41 . Trial registration date 2008-10-08.",2019,There was no difference in the relapse rate between the groups: 8/16 (50%) patients in the TAC group relapsed compared to 8/19 (42%) in the TAC/MMF group (p = 0.7).,"['idiopathic membranous glomerulonephritis', '2008-10-08', 'Forty patients with biopsy proven idiopathic MN and nephrotic syndrome', 'patients with MN']","['TAC', 'Mycophenolate mofetil and tacrolimus versus tacrolimus alone', 'MMF', 'angiotensin blockade, statins, diuretics and anticoagulation', 'Tacrolimus (TAC', 'TAC monotherapy', 'MMF to TAC', 'TAC combined with MMF', 'mycophenolate mofetil (MMF) to TAC']","['relapse rate of nephrotic syndrome', 'median time to remission', 'relapse rate', 'remission', 'remission rate, time to remission and change in renal function']","[{'cui': 'C0086445', 'cui_str': 'Idiopathic Membranous Glomerulonephritis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0456369', 'cui_str': 'Proven (qualifier value)'}, {'cui': 'C1608429', 'cui_str': 'Idiopathic (IPAH)'}, {'cui': 'C0027726', 'cui_str': 'Nephrotic Syndrome'}]","[{'cui': 'C3489891', 'cui_str': 'TAC(a)'}, {'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0003018', 'cui_str': 'Angiotensins'}, {'cui': 'C3540676', 'cui_str': 'Blockade'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0012798', 'cui_str': 'Diuretics'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0027726', 'cui_str': 'Nephrotic Syndrome'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}]",40.0,0.242055,There was no difference in the relapse rate between the groups: 8/16 (50%) patients in the TAC group relapsed compared to 8/19 (42%) in the TAC/MMF group (p = 0.7).,"[{'ForeName': 'Aikaterini', 'Initials': 'A', 'LastName': 'Nikolopoulou', 'Affiliation': 'Centre for Inflammatory Disease, Division of Immunology and Inflammation, Department of Medicine, Imperial College London, Du Cane Road, London, W12 0NN, UK. lina.nikolopoulou13@imperial.ac.uk.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Condon', 'Affiliation': 'Imperial College Renal and Transplant Centre, Imperial College Healthcare NHS Trust, Hammersmith Hospital, London, W12 0NN, UK.'}, {'ForeName': 'Tabitha', 'Initials': 'T', 'LastName': 'Turner-Stokes', 'Affiliation': 'Centre for Inflammatory Disease, Division of Immunology and Inflammation, Department of Medicine, Imperial College London, Du Cane Road, London, W12 0NN, UK.'}, {'ForeName': 'H Terence', 'Initials': 'HT', 'LastName': 'Cook', 'Affiliation': 'Centre for Inflammatory Disease, Division of Immunology and Inflammation, Department of Medicine, Imperial College London, Du Cane Road, London, W12 0NN, UK.'}, {'ForeName': 'Neill', 'Initials': 'N', 'LastName': 'Duncan', 'Affiliation': 'Imperial College Renal and Transplant Centre, Imperial College Healthcare NHS Trust, Hammersmith Hospital, London, W12 0NN, UK.'}, {'ForeName': 'Jack W', 'Initials': 'JW', 'LastName': 'Galliford', 'Affiliation': 'Imperial College Renal and Transplant Centre, Imperial College Healthcare NHS Trust, Hammersmith Hospital, London, W12 0NN, UK.'}, {'ForeName': 'Jeremy B', 'Initials': 'JB', 'LastName': 'Levy', 'Affiliation': 'Imperial College Renal and Transplant Centre, Imperial College Healthcare NHS Trust, Hammersmith Hospital, London, W12 0NN, UK.'}, {'ForeName': 'Liz', 'Initials': 'L', 'LastName': 'Lightstone', 'Affiliation': 'Centre for Inflammatory Disease, Division of Immunology and Inflammation, Department of Medicine, Imperial College London, Du Cane Road, London, W12 0NN, UK.'}, {'ForeName': 'Charles D', 'Initials': 'CD', 'LastName': 'Pusey', 'Affiliation': 'Centre for Inflammatory Disease, Division of Immunology and Inflammation, Department of Medicine, Imperial College London, Du Cane Road, London, W12 0NN, UK.'}, {'ForeName': 'Candice', 'Initials': 'C', 'LastName': 'Roufosse', 'Affiliation': 'Centre for Inflammatory Disease, Division of Immunology and Inflammation, Department of Medicine, Imperial College London, Du Cane Road, London, W12 0NN, UK.'}, {'ForeName': 'Thomas D', 'Initials': 'TD', 'LastName': 'Cairns', 'Affiliation': 'Imperial College Renal and Transplant Centre, Imperial College Healthcare NHS Trust, Hammersmith Hospital, London, W12 0NN, UK.'}, {'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Griffith', 'Affiliation': 'Imperial College Renal and Transplant Centre, Imperial College Healthcare NHS Trust, Hammersmith Hospital, London, W12 0NN, UK.'}]",BMC nephrology,['10.1186/s12882-019-1539-z']
974,30466512,Economic and Quality-of-Life Outcomes of Natriuretic Peptide-Guided Therapy for Heart Failure.,"BACKGROUND


The GUIDE-IT (GUIDing Evidence Based Therapy Using Biomarker Intensified Treatment in Heart Failure) trial prospectively compared the efficacy of an N-terminal pro-B-type natriuretic peptide (NT-proBNP)-guided heart failure treatment strategy (target NT-proBNP level <1,000 pg/ml) with optimal medical therapy alone in high-risk patients with heart failure and reduced ejection fraction. When the study was stopped for futility, 894 patients had been enrolled.
OBJECTIVES


The purpose of this study was to assess treatment-related quality-of-life (QOL) and economic outcomes in the GUIDE-IT trial.
METHODS


The authors prospectively collected a battery of QOL instruments at baseline and 3, 6, 12, and 24 months post-randomization (collection rates 90% to 99% of those eligible). The principal pre-specified QOL measures were the Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score and the Duke Activity Status Index (DASI). Cost data were collected for 735 (97%) U.S.
PATIENTS



RESULTS


Baseline variables were well balanced in the 446 patients randomized to the NT-proBNP-guided therapy and 448 to usual care. Both the KCCQ and the DASI improved over the first 6 months, but no evidence was found for a strategy-related difference (mean difference [biomarker-guided - usual care] at 24 months of follow-up 2.0 for DASI [95% confidence interval (CI): -1.3 to 5.3] and 1.1 for KCCQ [95% CI: -3.7 to 5.9]). Total winsorized costs averaged $5,919 higher in the biomarker-guided strategy (95% CI: -$1,795, +$13,602) over 15-month median follow-up.
CONCLUSIONS


A strategy of NT-proBNP-guided HF therapy had higher total costs and was not more effective than usual care in improving QOL outcomes in patients with heart failure and a reduced ejection fraction. (Guiding Evidence Based Therapy Using Biomarker Intensified Treatment [GUIDE-IT]; NCT01685840).",2018,A strategy of NT-proBNP-guided HF therapy had higher total costs and was not more effective than usual care in improving QOL outcomes in patients with heart failure and a reduced ejection fraction.,"['894 patients had been enrolled', '446 patients randomized to the NT-proBNP-guided therapy and 448 to usual care', 'Heart\xa0Failure', 'patients with heart failure and a reduced ejection fraction', 'high-risk patients with heart failure and reduced ejection fraction']","['N-terminal pro-B-type natriuretic peptide (NT-proBNP)-guided heart failure treatment strategy (target NT-proBNP level\xa0<1,000 pg/ml) with optimal medical therapy alone', 'Natriuretic Peptide-Guided Therapy', 'NT-proBNP-guided HF therapy', 'KCCQ']","['total costs', 'Overall Summary Score and the Duke Activity Status Index (DASI', 'Cost data', 'Total winsorized costs', 'DASI', 'quality-of-life (QOL) and economic outcomes', 'Kansas City Cardiomyopathy Questionnaire (KCCQ', 'QOL outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1963813', 'cui_str': 'NT-proBNP'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}]","[{'cui': 'C0754710', 'cui_str': 'Amino-terminal pro-brain natriuretic peptide'}, {'cui': 'C1963813', 'cui_str': 'NT-proBNP'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439297', 'cui_str': 'pg/mL'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}, {'cui': 'C1144709', 'cui_str': 'Natriuretic Peptides'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4720913', 'cui_str': 'Duke activity status index'}, {'cui': 'C0034380'}, {'cui': 'C0013557', 'cui_str': 'economics'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathies'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",446.0,0.0901497,A strategy of NT-proBNP-guided HF therapy had higher total costs and was not more effective than usual care in improving QOL outcomes in patients with heart failure and a reduced ejection fraction.,"[{'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Mark', 'Affiliation': 'Outcomes Research Group, Duke Clinical Research Institute, Durham, North Carolina; Clinical Trials Group, Duke Clinical Research Institute, Durham, North Carolina; Division of Cardiology, Duke University Medical Center, Durham, North Carolina. Electronic address: daniel.mark@duke.edu.'}, {'ForeName': 'Patricia A', 'Initials': 'PA', 'LastName': 'Cowper', 'Affiliation': 'Outcomes Research Group, Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Anstrom', 'Affiliation': 'Outcomes Research Group, Duke Clinical Research Institute, Durham, North Carolina; Clinical Trials Group, Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'Shubin', 'Initials': 'S', 'LastName': 'Sheng', 'Affiliation': 'Outcomes Research Group, Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'Melanie R', 'Initials': 'MR', 'LastName': 'Daniels', 'Affiliation': 'Outcomes Research Group, Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'J David', 'Initials': 'JD', 'LastName': 'Knight', 'Affiliation': 'Outcomes Research Group, Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'Khaula N', 'Initials': 'KN', 'LastName': 'Baloch', 'Affiliation': 'Outcomes Research Group, Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Davidson-Ray', 'Affiliation': 'Outcomes Research Group, Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Fiuzat', 'Affiliation': 'Division of Clinical Pharmacology, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Januzzi', 'Affiliation': 'Cardiology Division, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Whellan', 'Affiliation': 'Thomas Jefferson University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Ileana L', 'Initials': 'IL', 'LastName': 'Piña', 'Affiliation': 'Department of Medicine, Albert Einstein College of Medicine, Bronx, New York.'}, {'ForeName': 'Justin A', 'Initials': 'JA', 'LastName': 'Ezekowitz', 'Affiliation': 'Canadian VIGOUR Centre, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Kirkwood F', 'Initials': 'KF', 'LastName': 'Adams', 'Affiliation': 'University of North Carolina-Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Lawton S', 'Initials': 'LS', 'LastName': 'Cooper', 'Affiliation': 'Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, Bethesda, Maryland.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': ""O'Connor"", 'Affiliation': 'Inova Heart and Vascular Center, Fairfax, Virginia. Electronic address: https://twitter.com/coconnormd.'}, {'ForeName': 'G Michael', 'Initials': 'GM', 'LastName': 'Felker', 'Affiliation': 'Clinical Trials Group, Duke Clinical Research Institute, Durham, North Carolina; Division of Cardiology, Duke University Medical Center, Durham, North Carolina.'}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2018.08.2184']
975,16142049,[Atomoxetine: a new treatment for Attention Deficit/Hyperactivity Disorder (ADHD) in children and adolescents].,"This paper provides a review of safety and efficacy data as well as of pharmacological characteristics of atomoxetine, a new drug treatment for the Attention Deficit/Hyperactivity Disorder (ADHD). To date, the only pharmacological treatment available in France for children and adolescents diagnosed with ADHD is methylphenidate, a psychostimulant drug. However, the clinical response to methylphenidate may be absent or insufficient in about 20-30% drug-treated children while the occurrence of adverse effects with methylphenidate (sleep disturbances, loss of appetite, tics increase...) may sometimes require a dose reduction or even the discontinuation of the treatment. Atomoxetine is an alternative candidate drug for the treatment of ADHD. The drug has been developed with respect to the actual standards of investigation of drugs intended to a -pediatric use. Atomoxetine has been recently licensed in the USA for the treatment of ADHD. Atomoxetine is a potent inhibitor of the norepinephrine transporter that shows only mini-mal affinity for other neurotransmitter systems. Although pharmacokinetics of atomoxetine is influenced by the polymorphism of the CYP2D6 metabolic pathway, safety and -tolerability data reported during clinical trials did not show any difference in poor versus extensive metabolizers. In addition, atomoxetine does not inhibit nor induce the CYP2D6 enzymatic function. The major metabolite of atomoxetine is 4-hydroxyatomoxetine, a pharmacologically active metabolic found in very low plasma concentrations in pediatric patients, suggesting that it plays only a minor role in the norepinephrine reuptake inhibition. Preliminary studies were aimed to assess the effective dose range of atomoxetine and to evaluate its safety and efficacy on the reduction of ADHD symptoms in adults and children diagnosed with ADHD. Main data on the child and adolescent population were obtained in four double-blind, randomized, placebo-controlled trials: two identical pivotal trials, a multiple dose study, a once-daily dose study. The first two pivotal trials were carried out in ADHD children aged 7-13 years, treated with atomoxetine vs placebo for a duration of 9 weeks. Patients presenting comorbidities (ie conduct disorder, -anxiety, depression) as well as a history of previous treatment with methylphenidate were also eligible to participate. The primary outcome was the reduction of the score on the ADHD rating scale, ADHD-RS ; secondary criteria included the responder's rate (patients with an ADHD-RS score reduction of 25% or above), the Clinical Global Impression Scale and the Conners Parent Rating Scale. With a mean dose of 1.5 mg/kg/day, atomoxetine showed a significant reduction of mean ADHD-RS scores at endpoint (ANOVA, p<0.001) (table II). Yet, the clinical significance of both studies is limited since efficacy was scored only in a social/familial setting and not in classroom conditions. In addition, intermediate results from baseline to endpoint were not presented in the publication. The multiple dose trial showed a significant reduction of the symptom score at the 1.2 and 1.8 mg/kg/day doses. The objective of the last study was to assess the efficacy of a single daily dose of atomoxetine versus placebo during a 6 week-treatment. Patients were evaluated by parents, investigators, as well as by teachers. The superiority of atomoxetine was demonstrated as compared to the placebo and the effect size of the daily dosing was similar to that reported with multiple doses. Preliminary data on ADHD patients presenting comorbidities showed that atomoxetine alone signi-ficantly reduced the symptom scores of anxiety and depression and similarly to atomoxetine associated with fluoxetine. In ADHD children with the oppositional defiant disorder, oppositional symptoms were reduced in the group receiving atomoxetine 1.8 mg/kg/day. Preliminary results in children with ADHD and chronic tics or Tourette syndrome showed a significant reduction of ADHD symptoms and a tendency to the decrease of tics. Tolerance and safety data pooled from the child and adolescent trials were acceptable. Study discontinuations due to adverse events in the four registration studies were only 2.8%. The most frequent adverse effects reported were gastrointestinal symptoms and decreased appetite. Weight loss reported early in clinical studies tended to stabilize during the open-label extension phases lasting up to 9 months. A retrospective comparison showed that the adverse event profile of poor metabolizers was similar to that of extensive metabolizers. In summary, data presented suggest that atomoxetine is a safe and effective drug for the treatment of ADHD in children and adolescents. Further studies are expected to accurately define the place of atomoxetine in the treatment strategy of ADHD, a chronic and invalidating disorder affecting 3 to 7% of school-aged children.",2005,Preliminary data on ADHD patients presenting comorbidities showed that atomoxetine alone signi-ficantly reduced the symptom scores of anxiety and depression and similarly to atomoxetine associated with fluoxetine.,"['ADHD children aged 7-13 years, treated with', 'children and adolescents diagnosed with ADHD', 'child and adolescent population', 'Patients presenting comorbidities (ie conduct disorder, -anxiety, depression) as well as a history of previous treatment with', 'children and adolescents', 'adults and children diagnosed with ADHD', 'children with ADHD and chronic tics or Tourette syndrome', 'pediatric patients', 'Attention Deficit/Hyperactivity Disorder (ADHD) in children and adolescents', 'for a duration of 9 weeks']","['methylphenidate', 'atomoxetine', 'placebo', 'atomoxetine versus placebo', 'fluoxetine', 'atomoxetine vs placebo', 'Atomoxetine']","['oppositional defiant disorder, oppositional symptoms', 'ADHD symptoms', 'Clinical Global Impression Scale and the Conners Parent Rating Scale', 'tics', 'Weight loss', 'gastrointestinal symptoms and decreased appetite', 'mean ADHD-RS scores', 'symptom scores of anxiety and depression', 'CYP2D6 enzymatic function', 'symptom score', ""reduction of the score on the ADHD rating scale, ADHD-RS ; secondary criteria included the responder's rate""]","[{'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0149654', 'cui_str': 'Conduct Disorder'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0278076', 'cui_str': 'Habit Chorea'}, {'cui': 'C0040517', 'cui_str': 'Chronic Motor and Vocal Tic Disorder'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0076823', 'cui_str': 'atomoxetine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0016365', 'cui_str': 'Fluoxetine'}]","[{'cui': 'C0029121', 'cui_str': 'Oppositional Defiant Disorder'}, {'cui': 'C0860661', 'cui_str': 'Oppositional'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C3639708', 'cui_str': 'Clinical global impression scale'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0222045'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0232462', 'cui_str': 'Decrease in appetite (finding)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0057223', 'cui_str': 'CYP2D6'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]",,0.0569386,Preliminary data on ADHD patients presenting comorbidities showed that atomoxetine alone signi-ficantly reduced the symptom scores of anxiety and depression and similarly to atomoxetine associated with fluoxetine.,"[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Purper-Ouakil', 'Affiliation': ""Service de Psychopathologie de l'Enfant et de l'Adolescent, Hôpital Robert Debré, boulevard Sérurier, 75019 Paris.""}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Fourneret', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Wohl', 'Affiliation': ''}, {'ForeName': 'J-P', 'Initials': 'JP', 'LastName': 'Rénéric', 'Affiliation': ''}]",L'Encephale,[]
976,31229396,Building Blocks for Healthy Children: Evaluation of a Child Care Center-Based Obesity Prevention Pilot Among Low-Income Children.,"OBJECTIVE


To assess the impact of a multilevel nutrition intervention for low-income child care environments, staff, and center-enrolled children.
DESIGN


A cluster-randomized, controlled trial conducted among eligible centers. Staff and parent self-report surveys and objective field observations at baseline and follow-up were conducted.
SETTING


A total of 22 low-income child care centers (enrolling ≥ 25 2- to 5-year-old children).
PARTICIPANTS


Children aged 18-71 months; 408 children and 97 staff were randomized into intervention (208 children and 50 staff) and waitlist-control groups (200 children and 45 staff). Retention rates were high (87% for children and 93% for staff).
INTERVENTION(S)


A 6-session, 6-month director's child nutrition course with on-site technical support for center teachers.
MAIN OUTCOME MEASURE(S)


Center nutrition/physical activity environment; staff feeding styles, dietary patterns, and attitudes about food; child food preferences and dietary patterns.
ANALYSIS


Covariance regression analyses to assess the intervention effect, adjusting for clustering within centers.
RESULTS


Significant intervention effects were found for the center nutrition training/education environment (b = 3.01; P = .03), nutrition total scores (b = 1.29; P = .04), and staff-level prompting/encouraging feeding styles (b = 0.38; P = .04). No significant intervention effects were found for child-level measures.
CONCLUSIONS AND IMPLICATIONS


Curriculum-driven training and implementation support improved nutritional policies and practices and staff-child interactions during meals. Future research could extend the intervention to families and the evaluation to children's dietary behaviors and weight changes.",2019,"RESULTS


Significant intervention effects were found for the center nutrition training/education environment (b = 3.01; P = .03), nutrition total scores (b = 1.29; P = .04), and staff-level prompting/encouraging feeding styles (b = 0.38; P = .04). ","['Healthy Children', 'A total of 22 low-income child care centers', 'Children aged 18-71 months; 408 children and 97 staff were randomized into intervention (208 children and 50 staff) and waitlist-control groups (200 children and 45 staff', 'enrolling ≥ 25 2- to 5-year-old children', 'low-income child care environments, staff, and center-enrolled children', 'eligible centers', 'Low-Income Children']","['Child Care Center-Based Obesity Prevention Pilot', 'multilevel nutrition intervention']","['staff-level prompting/encouraging\xa0feeding styles', 'Retention rates', 'center nutrition training/education environment', 'nutrition total scores', 'child-level measures']","[{'cui': 'C0686744', 'cui_str': 'Well child (finding)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0008078', 'cui_str': 'Childrens Health'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C4517769', 'cui_str': 'Four hundred and eight'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0014406', 'cui_str': 'Environment'}]","[{'cui': 'C0008078', 'cui_str': 'Childrens Health'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0473169', 'cui_str': 'Aviators'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}]","[{'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",408.0,0.0522384,"RESULTS


Significant intervention effects were found for the center nutrition training/education environment (b = 3.01; P = .03), nutrition total scores (b = 1.29; P = .04), and staff-level prompting/encouraging feeding styles (b = 0.38; P = .04). ","[{'ForeName': 'Brittany R', 'Initials': 'BR', 'LastName': 'Schuler', 'Affiliation': 'School of Social Work, College of Public Health, Temple University, Philadelphia, PA. Electronic address: brittany.schuler@temple.edu.'}, {'ForeName': 'Baylie', 'Initials': 'B', 'LastName': 'Fowler', 'Affiliation': 'Department of Pediatrics, University of Maryland School of Medicine, Baltimore, MD.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Rubio', 'Affiliation': 'University of Minnesota Medical School, Twin Cities Campus, Twin Cities, MN.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Kilby', 'Affiliation': 'Maryland State Department of Education, Baltimore, MD.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Pediatrics, University of Maryland School of Medicine, Baltimore, MD.'}, {'ForeName': 'Erin R', 'Initials': 'ER', 'LastName': 'Hager', 'Affiliation': 'Department of Pediatrics, University of Maryland School of Medicine, Baltimore, MD.'}, {'ForeName': 'Maureen M', 'Initials': 'MM', 'LastName': 'Black', 'Affiliation': 'Department of Pediatrics, University of Maryland School of Medicine, Baltimore, MD; Distinguished Fellow, RTI International, Research Triangle Park, NC.'}]",Journal of nutrition education and behavior,['10.1016/j.jneb.2019.04.017']
977,31506240,Effects of handwriting exercise on functional outcome in Parkinson disease: A randomized controlled trial.,"Parkinson disease (PD) patients frequently experience micrographia and difficulty writing, which could potentially impact their quality of life. This study aimed to determine whether handwriting exercise could improve fine manual motor function in PD. The study was a randomized controlled trial assessing the efficacy of a 4-week handwriting exercise using a newly developed handwriting practice book. The primary endpoint was an improvement in the time used to complete the handwriting test. Secondary endpoints were accuracy of the writing performance, patient's subjective rating scale of their handwriting and a UPDRS part III motor examination. Of a total of 46 subjects, 23 were randomly assigned to the handwriting exercise group. After 4 weeks, the mean time used to complete the test was significantly lower in the exercise group, compared to the control group (143.43 ± 34.02 vs. 175 ± 48.88 s, p = 0.015). Mean time used to complete the handwriting test decreased from the baseline by 16.16% in the exercise group, but increased by 3.63% in the control group (p < 0.001). Significant improvements were also observed by assessing the subjective rating scale and the UPDRS part III scores. The 4-week handwriting exercise using the studied handwriting practice book appears to promote an improvement in writing speed and motor function of hands. The optimal duration and frequency of the exercise, the quantity and characteristic of the letters in the handwriting practice book, and the benefits of the exercise in other languages merit further studies.",2020,"Mean time used to complete the handwriting test decreased from the baseline by 16.16% in the exercise group, but increased by 3.63% in the control group (p < 0.001).","['Parkinson disease', 'Of a total of 46 subjects']","['handwriting exercise', '4-week handwriting exercise', 'handwriting exercise group']","['functional outcome', 'Mean time used to complete the handwriting test', 'time used to complete the handwriting test', ""accuracy of the writing performance, patient's subjective rating scale of their handwriting and a UPDRS part III motor examination"", 'mean time used to complete the test', 'writing speed and motor function of hands', 'subjective rating scale and the UPDRS part III scores']","[{'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]","[{'cui': 'C0018582', 'cui_str': 'Handwriting'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0018582', 'cui_str': 'Handwriting'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0222045'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0449719', 'cui_str': 'Part (attribute)'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0234130', 'cui_str': 'Motor function (observable entity)'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",46.0,0.0240727,"Mean time used to complete the handwriting test decreased from the baseline by 16.16% in the exercise group, but increased by 3.63% in the control group (p < 0.001).","[{'ForeName': 'Nisa', 'Initials': 'N', 'LastName': 'Vorasoot', 'Affiliation': 'Division of Neurology, Department of Medicine, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Pichet', 'Initials': 'P', 'LastName': 'Termsarasab', 'Affiliation': 'Division of Neurology, Department of Medicine, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Kunlawat', 'Initials': 'K', 'LastName': 'Thadanipon', 'Affiliation': 'Section for Clinical Epidemiology and Biostatistics, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Teeratorn', 'Initials': 'T', 'LastName': 'Pulkes', 'Affiliation': 'Division of Neurology, Department of Medicine, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand. Electronic address: teeratorn.pul@mahidol.ac.th.'}]",Journal of clinical neuroscience : official journal of the Neurosurgical Society of Australasia,['10.1016/j.jocn.2019.08.119']
978,15627046,[Antipsychotics in bipolar disorders].,"This article is a review of the various treatments that are currently available, in particular in France, for the treatment of bipolar disorders. This article specifically addresses the use of novel antipsychotic agents as alternative therapy to a lithium therapy and/or the use of conventional antipsychotics. The prevalence of bipolar disorder over a lifetime is around 1% of the general population. Bipolar disorder consists of alternating depressive and manic episodes. It mainly affects younger subjects, and is often associated with alcohol and drug addictions. There are two main subtypes of bipolar disorder. According to the DSM IV-R, type 1 of bipolar disorder is characterised when at least one manic episode (or a mixed episode) has been diagnosed. Type 2 of bipolar disorder is related to patients enduring recurrent depressive episodes but no manic episode. Type 2 affects women more frequently as opposed to type 1 affecting individuals of both sexes. Manic-depressive disorder (or cyclo-thymic disorder) appears in relation to patients who has never suffered manic episode, mixed episode or severe depressive episode but have undergone numerous periods with some symptoms of depression and hypomanic symptoms over a two-year period during which any asymptomatic periods last no longer than two months. The average age of the person going through a first episode (often a depressive one) is 20 years-old. Untreated bipolar patients may endure more than ten manic or depressive episodes. Finally, in relation to 10 to 20% of patients, the bipolar disorder will turn into a fast cycle form, either spontaneously or as a result of certain medical treatments. Psychiatrists are now able to initiate various treating strategies which are most likely to be effective as a result of the identification of clinical subtypes of the bipolar disorder. Lithium therapy has been effectively and acutely used for patients with pure or elated mania and its prophylaxis. However, lithium medication may worsen depressive symptoms when used for a long term maintenance therapy. Additionally, mixed mania, rapid cycling type patients and bipolar disorder associated with substance abuse do not respond well to lithium therapy. In addition to the lithium therapy or in place of a lithium therapy, one can report the frequent use of antipsychotic agents in respect of patients with bipolar disorder during both the acute and maintenance phases of treatment. Antipsychotic agents have been used for almost forty years and may be used in combination with a lithium therapy. Conventional antipsychotics are effective but they may induce late dyskinesia, weight gain, sedation, sexual dysfunction and depression. These adverse side effects often lead to non compliance in particular in circumstances where antipsychotic agents are combined with a lithium therapy. A number of alternative somatic treatment approaches have been reported for patients who do not respond well or who are intolerant to lithium therapy. As such, valproate has received regulatory approval for the acute treatment of mania and carbamazepine has been indicated for this condition in a number of countries. Divalproex (Depakote) has recently obtained the authorization to market in France and may be prescribed for manic states or hypomanic states that do not tolerate lithium therapy or for which lithium therapy is contraindicated. A number of other anticonvulsants (lamotrigine, gabapentin and topiramate) are currently being tested. Because of the side effects of the conventional antipsychotic agents, atypical antipsychotic agents are currently on trial and appear to be of interest in the treatment of bipolar disorders. Currently, a number of prospective studies are available with clozapine, risperidone and olanzapine in the treatment of bipolar disorder. Most are short-term studies. Recent randomised, double-blind, placebo-controlled studies have shown clozapine, risperidone and olanzapine to be effective with antimanic and antidepressive effects, both as monotherapy and as add-on maintenance therapy with lithium or valproate. They also have a favorable side effect profile and a positive effect on overall functioning. Similarly, valproate combined with antipsychotics provides greater improvement in mania than antipsychotic medication alone and results in lower dosage of the antipsychotic medication. There is currently no double-blind study regarding the use of clozapine for bipolar disorders. However, based on the results of a number of open-label studies, clozapine appears to be effective in relation to schizo-affective and bipolar patients including those with rapid cycling or those who respond inadequately to mood stabilizers, carbamazepine, valproate or conventional antipsychotics. Clozapine seems to be more appropriate for bipolar and schizo-affective patients than schizophrenics. In particular, studies show that patients with manic and mixed-psychotic state of illness are better responders than patients with major depressive syndromes. Four open studies suggest the efficacy of clozapine in the maintenance treatment of bipolar disorder and three prospective, open-label studies show the efficacy of clozapine in the manic state of the illness. However, the number of patients in the studies was not important and these studies are not controlled. Clozapine has also adverse side affects, one of which consisting of a major risk of agranulocytosis and, potentially, death. In addition, clozapine has been shown to produce significant weight gain and sialorrhea as well as significant anticholinergic effects. As a result, clozapine should not be prescribed in the first place. As opposed to clozapine, there are open-label reports and controlled studies in respect of risperidone and olanzapine. Two recent double-blind studies of acute mania found olanzapine to be more effective than placebo. Based on these two studies, olanzapine has recently been approved for the indication of mania. The effects of olanzapine and divalproex in the treatment of mania have also been compared in a large randomized clinical trial. The olanzapine treatment group had significantly greater mean improvement of mania ratings and a significantly greater proportion of patients achieving protocol-defined remission. Significantly more weight gain and cases of dry mouth, increased appetite and somnolence were reported with olanzapine while more cases of nausea were reported with divalproex. The comparison of olanzapine with lithium for the treatment of mania has also been the subject of a double-blind randomized controlled trial. That study shows no differences between the two drugs. While these studies support the idea that olanzapine has direct acute anti-manic effects, a number of authors are of the opinion that olanzapine may have specific prophylactic mood-stabilizing properties. Olanzapine would appear to be effective in the maintenance treatment, as it exhibited both antimanic and antidepressant effects. Systematic trials have shown that risperidone may be effective and safe in the treatment of acute mania, as an add-on therapy with lithium or valproate (open studies and two controlled double-blind studies) and as monotherapy (open studies). In an open, multi-center, 6-month study, risperidone seems to be effective and safe as long-term adjunctive therapy in treatment-resistant bipolar and schizo-affective disorders, with no exacerbation of manic symptoms. Risperidone had few adverse side effects (and where there were any, they were mostly mild), mostly consisting of APS and weight gain. A naturalistic comparison of clozapine, risperidone and olanzapine in the treatment of bipolar disorder suggests that the efficacy and tolerability of the three treatments are similar. One major differentiation factor of these drugs appears to be weight gain, particularly between olanzapine and risperidone. However, this may partially be caused by the use of mood-stabilizing agents. Bipolar and schizo-affective patients now require combination therapy approach because of the cyclic nature of these disorders. Many studies report the combination of mood-stabilizing agents with conventional antipsychotics and atypical antipsychotics. Combination therapies produce a number of adverse side effects. Atypical antipsychotics (other than clozapine) are now rated as first-line agents for adjunctive treatment of mania because they produce less adverse side effects. Atypical antipsychotics are also rated as first-line agents for combined treatment of psychotic depression and they are strongly preferred when an antipsychotic is required for long-term maintenance.",2004,"Significantly more weight gain and cases of dry mouth, increased appetite and somnolence were reported with olanzapine while more cases of nausea were reported with divalproex.","['patients who do not respond well or who are intolerant to lithium therapy', 'patients with pure or elated mania and its prophylaxis', 'Manic-depressive disorder (or cyclo-thymic disorder', 'bipolar disorders']","['clozapine, risperidone and olanzapine', 'Lithium therapy', 'risperidone and olanzapine', 'anticonvulsants (lamotrigine, gabapentin and topiramate', 'olanzapine with lithium', 'valproate', 'Conventional antipsychotics', 'divalproex', 'carbamazepine, valproate or conventional antipsychotics', 'lithium or valproate', 'Antipsychotic agents', 'Olanzapine', 'Divalproex (Depakote', 'antipsychotics', 'lithium medication', 'olanzapine and divalproex', 'lithium therapy', 'olanzapine', 'placebo', 'Clozapine', 'clozapine', 'Risperidone', 'risperidone']","['adverse side effects', 'weight gain and sialorrhea', 'nausea', 'weight gain and cases of dry mouth, increased appetite and somnolence', 'mean improvement of mania ratings', 'weight gain', 'efficacy and tolerability', 'depressive symptoms', 'late dyskinesia, weight gain, sedation, sexual dysfunction and depression', 'proportion of patients achieving protocol-defined remission']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0204592', 'cui_str': 'Lithium therapy (procedure)'}, {'cui': 'C0338831', 'cui_str': 'Manic State'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C0005586', 'cui_str': 'Psychosis, Manic-Depressive'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0009079', 'cui_str': 'Clozapine'}, {'cui': 'C0073393', 'cui_str': 'Risperidone'}, {'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C0204592', 'cui_str': 'Lithium therapy (procedure)'}, {'cui': 'C0003286', 'cui_str': 'Anticonvulsive Agents'}, {'cui': 'C0064636', 'cui_str': 'lamotrigine'}, {'cui': 'C0060926', 'cui_str': 'gabapentin'}, {'cui': 'C0076829', 'cui_str': 'topiramate'}, {'cui': 'C3540800', 'cui_str': 'Lithium'}, {'cui': 'C0080356', 'cui_str': 'Valproate'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0042291', 'cui_str': 'Valproic Acid'}, {'cui': 'C0006949', 'cui_str': 'Carbamazepine'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic Drugs'}, {'cui': 'C0719751', 'cui_str': 'Depakote'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0037036', 'cui_str': 'Hypersalivation'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0043352', 'cui_str': 'Mouth Dryness'}, {'cui': 'C0232461', 'cui_str': 'Increased appetite (finding)'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0338831', 'cui_str': 'Manic State'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C1869094', 'cui_str': 'Dyskinesia (SMQ)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0549622', 'cui_str': 'Sexual disorder (disorder)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}]",,0.032815,"Significantly more weight gain and cases of dry mouth, increased appetite and somnolence were reported with olanzapine while more cases of nausea were reported with divalproex.","[{'ForeName': 'M-N', 'Initials': 'MN', 'LastName': 'Vacheron-Trystram', 'Affiliation': 'Service du Docteur Caroli, Hôpital Sainte-Anne, 1 rue Cabanis, 75014 Paris, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Braitman', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Cheref', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Auffray', 'Affiliation': ''}]",L'Encephale,[]
979,31925340,Effect of rivaroxaban on urinary albumin excretion in patients with atrial fibrillation and chronic kidney disease: a randomized trial (X-NOAC).,,2020,,['patients with atrial fibrillation and chronic kidney disease'],['rivaroxaban'],['urinary albumin excretion'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}]","[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}]","[{'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}]",,0.0298132,,"[{'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Tanaka', 'Affiliation': 'Department of Cardiovascular Medicine, Saga University, Saga, Japan. tanakaa2@cc.saga-u.ac.jp.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Suzuki', 'Affiliation': 'Department of Cardiology, Yokohama Minami Kyosai Hospital, Yokohama, Japan.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Matsunaga', 'Affiliation': 'Department of Internal Medicine, Imari-Arita Kyoritsu Hospital, Matsuura, Japan.'}, {'ForeName': 'Isao', 'Initials': 'I', 'LastName': 'Taguchi', 'Affiliation': 'Department of Cardiology, Dokkyo Medical University Saitama Medical Center, Koshigaya, Japan.'}, {'ForeName': 'Shiro', 'Initials': 'S', 'LastName': 'Nakahara', 'Affiliation': 'Department of Cardiology, Dokkyo Medical University Saitama Medical Center, Koshigaya, Japan.'}, {'ForeName': 'Atsuko', 'Initials': 'A', 'LastName': 'Chihara', 'Affiliation': 'Department of Cardiovascular Medicine, Saga University, Saga, Japan.'}, {'ForeName': 'Jun-Ichi', 'Initials': 'JI', 'LastName': 'Oyama', 'Affiliation': 'Department of Cardiovascular Medicine, Saga University, Saga, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Node', 'Affiliation': 'Department of Cardiovascular Medicine, Saga University, Saga, Japan. node@cc.saga-u.ac.jp.'}]",Hypertension research : official journal of the Japanese Society of Hypertension,['10.1038/s41440-019-0384-6']
980,15738857,[Effect of different variables on the outcome of various cognitive-behavioral treatment modalities for panic disorder with agoraphobia].,"The efficacy of cognitive-behavioral therapy (CBT) is clearly demonstrated in the treatment of panic-disorder with agoraphobia (PDA). Between 70% and 90% of people with PDA obtain an higher global functioning level after CBT, yet symptoms remain in 10 to 30% of participants after treatment termination. The goal of the present study is to find which variables have an effect on different CBT modalities (individual, group, self-help) for persons with moderate and high PDA. Eighty-four persons were randomly assigned to one of three treatment modalities. Evaluations were made before treatment, immediately after and one year later. Results show that sex, number of years with agoraphobia and anxiety level significantly predict outcome at post-test for the individual modality. However, only the number of years with agoraphobia is a strong predictor one year later for this treatment modality. For the self-help modality, no predictor is significant neither at post-test nor one year later. For the group modality, the agoraphobic avoidance predicts outcome at post-test whereas symptoms severity predicts outcome one year later.",2004,"For the group modality, the agoraphobic avoidance predicts outcome at post-test whereas symptoms severity predicts outcome one year later.","['panic-disorder with agoraphobia (PDA', 'Eighty-four persons', 'panic disorder with agoraphobia', 'persons with moderate and high PDA']","['cognitive-behavioral therapy (CBT', 'various cognitive-behavioral treatment modalities']",['global functioning level'],"[{'cui': 'C0236800', 'cui_str': 'Panic disorder with agoraphobia (disorder)'}, {'cui': 'C4319623', 'cui_str': '84 (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",84.0,0.0170028,"For the group modality, the agoraphobic avoidance predicts outcome at post-test whereas symptoms severity predicts outcome one year later.","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Marchand', 'Affiliation': 'Département de Psychologie, Université du Québec à Montréal, CP 8888, Succursale Centre-Ville, Montréal, Québec, Canada H3C 3P8. marchand.andre@uqam.ca'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Germain', 'Affiliation': ''}]",L'Encephale,[]
981,31994703,"Pharmacodynamics, pharmacokinetics, and safety of single-dose subcutaneous administration of selatogrel, a novel P2Y12 receptor antagonist, in patients with chronic coronary syndromes.","AIMS


To study the pharmacodynamics and pharmacokinetics of selatogrel, a novel P2Y12 receptor antagonist for subcutaneous administration, in patients with chronic coronary syndromes (CCS).
METHODS AND RESULTS


In this double-blind, randomized study of 345 patients with CCS on background oral antiplatelet therapy, subcutaneous selatogrel (8 mg, n = 114; or 16 mg, n = 115) was compared with placebo (n = 116) (ClinicalTrials.gov: NCT03384966). Platelet aggregation was assessed over 24 h (VerifyNow assay) and 8 h (light transmittance aggregometry; LTA). Pharmacodynamic responders were defined as patients having P2Y12 reaction units (PRU) <100 at 30 min post-dose and lasting ≥3 h. At 30 min post-dose, 89% of patients were responders to selatogrel 8 mg, 90% to selatogrel 16 mg, and 16% to placebo (P < 0.0001). PRU values (mean ± standard deviation) were 10 ± 25 (8 mg), 4 ± 10 (16 mg), and 163 ± 73 (placebo) at 15 min and remained <100 up to 8 h for both doses, returning to pre-dose or near pre-dose levels by 24 h post-dose. LTA data showed similarly rapid and potent inhibition of platelet aggregation. Selatogrel plasma concentrations peaked ∼30 min post-dose. Selatogrel was safe and well-tolerated with transient dyspnoea occurring overall in 7% (16/229) of patients (95% confidence interval: 4-11%).
CONCLUSIONS


Selatogrel was rapidly absorbed following subcutaneous administration in CCS patients, providing prompt, potent, and consistent platelet P2Y12 inhibition sustained for ≥8 h and reversible within 24 h. Further studies of subcutaneous selatogrel are warranted in clinical scenarios where rapid platelet inhibition is desirable.",2020,"Selatogrel was safe and well-tolerated with transient dyspnoea occurring overall in 7% (16/229) of patients (95% confidence interval: 4-11%).
","['patients with chronic coronary syndromes', '345 patients with', 'patients with chronic coronary syndromes (CCS']","['placebo', 'CCS on background oral antiplatelet therapy, subcutaneous selatogrel']","['safe and well-tolerated with transient dyspnoea occurring overall', 'PRU values', 'Selatogrel plasma concentrations', 'Platelet aggregation', 'Pharmacodynamics, pharmacokinetics, and safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C1522438', 'cui_str': 'SC use'}]","[{'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0677599', 'cui_str': 'Platelet aggregation'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",345.0,0.368598,"Selatogrel was safe and well-tolerated with transient dyspnoea occurring overall in 7% (16/229) of patients (95% confidence interval: 4-11%).
","[{'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Storey', 'Affiliation': 'Department of Infection, Immunity and Cardiovascular Disease, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Gurbel', 'Affiliation': 'Inova Heart and Vascular Institute, Falls Church, VA, USA.'}, {'ForeName': 'Jurrien', 'Initials': 'J', 'LastName': 'Ten Berg', 'Affiliation': 'Department of Cardiologie, St Antonius Hospital, Nieuwegein, Netherlands.'}, {'ForeName': 'Corine', 'Initials': 'C', 'LastName': 'Bernaud', 'Affiliation': 'Idorsia Pharmaceuticals Ltd, Allschwil, Switzerland.'}, {'ForeName': 'George D', 'Initials': 'GD', 'LastName': 'Dangas', 'Affiliation': 'Division of Cardiology, Mount Sinai Hospital, New York, NY, USA.'}, {'ForeName': 'Jean-Marie', 'Initials': 'JM', 'LastName': 'Frenoux', 'Affiliation': 'Idorsia Pharmaceuticals Ltd, Allschwil, Switzerland.'}, {'ForeName': 'Diana A', 'Initials': 'DA', 'LastName': 'Gorog', 'Affiliation': 'University of Hertfordshire, Hertfordshire, UK.'}, {'ForeName': 'Abdel', 'Initials': 'A', 'LastName': 'Hmissi', 'Affiliation': 'Idorsia Pharmaceuticals Ltd, Allschwil, Switzerland.'}, {'ForeName': 'Vijay', 'Initials': 'V', 'LastName': 'Kunadian', 'Affiliation': 'Faculty of Medical Sciences, Newcastle University, Newcastle, UK.'}, {'ForeName': 'Stefan K', 'Initials': 'SK', 'LastName': 'James', 'Affiliation': 'Department of Medical Sciences, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Jean-Francois', 'Initials': 'JF', 'LastName': 'Tanguay', 'Affiliation': 'Department of Medicine, Institut de Cardiologie de Montréal, Université de Montréal, Montreal, Canada.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Tran', 'Affiliation': 'Inova Heart and Vascular Institute, Falls Church, VA, USA.'}, {'ForeName': 'Dietmar', 'Initials': 'D', 'LastName': 'Trenk', 'Affiliation': 'Department of Cardiology and Angiology II, University Heart Center Freiburg-Bad Krozingen, Bad Krozingen, Germany.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Ufer', 'Affiliation': 'Idorsia Pharmaceuticals Ltd, Allschwil, Switzerland.'}, {'ForeName': 'Pim', 'Initials': 'P', 'LastName': 'Van der Harst', 'Affiliation': 'Department of Cardiology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Arnoud W J', 'Initials': 'AWJ', 'LastName': ""Van't Hof"", 'Affiliation': 'Department of Cardiology, Maastricht University Medical Centre (MUMC), Maastricht, Netherlands.'}, {'ForeName': 'Dominick J', 'Initials': 'DJ', 'LastName': 'Angiolillo', 'Affiliation': 'Division of Cardiology, University of Florida College of Medicine, Jacksonville, FL, USA.'}]",European heart journal,['10.1093/eurheartj/ehz807']
982,32103495,Omega-3 PUFA and aspirin as adjuncts to periodontal debridement in patients with periodontitis and type 2 diabetes mellitus: Randomized clinical trial.,"BACKGROUND


Supplementation with omega-3 polyunsaturated fatty acids (ω-3 PUFA) and low-dose aspirin (ASA) have been proposed as a host modulation regimen to control chronic inflammatory diseases. The aim of this study was to investigate the clinical and immunological impact of orally administered ω-3 PUFA and ASA as adjuncts to periodontal debridement for the treatment of periodontitis in patients type 2 diabetes.
METHODS


Seventy-five patients (n = 25/group) were randomly assigned to receive placebo and periodontal debridement (CG), ω-3 PUFA + ASA (3 g of fish oil/d + 100 mg ASA/d for 2 months) after periodontal debridement (test group [TG]1), or ω-3 PUFA + ASA (3 g of fish oil/d + 100 mg ASA/d for 2 months) before periodontal debridement (TG2). Periodontal parameters and GCF were collected at baseline (t0), 3 months after periodontal debridement and ω-3 PUFA + ASA or placebo for TG1 and CG (t1), after ω-3 PUFA + ASA (before periodontal debridement) for TG2 (t1), and 6 months after periodontal debridement (all groups) (t2). GCF was analyzed for cytokine levels by multiplex ELISA.
RESULTS


Ten patients (40%) in TG1 and nine patients (36%) in TG2 achieved the clinical endpoint for treatment (less than or equal to four sites with probing depth ≥ 5 mm), as opposed to four (16%) in CG. There was clinical attachment gain in moderate and deep pockets for TG1. IFN-γ and interleukin (IL)-8 levels decreased over time for both test groups. IL-6 levels were lower for TG1. HbA1c levels reduced for TG1.
CONCLUSION


Adjunctive ω-3 and ASA after periodontal debridement provides clinical and immunological benefits to the treatment of periodontitis in patients with type 2 diabetes.",2020,IFN-γ and IL-8 levels decreased over time for both test groups.,"['patients with periodontitis and type 2 diabetes mellitus', 'patients with type 2 diabetes', 'Seventy-five patients (n = 25/group', 'patients type 2 diabetes']","['Omega-3 PUFA and aspirin', 'ω-3 PUFA + ASA or placebo', 'ω-3 PUFA and ASA', 'placebo and periodontal debridement (CG), ω-3 PUFA + ASA (3g of fish oil/day + 100mg ASA/day for 2 months) after periodontal debridement (Test Group [TG]1), or ω-3 PUFA + ASA (3g of fish oil/day + 100mg ASA/day for 2 months) before periodontal debridement (TG2', 'omega-3 polyunsaturated fatty acids (ω-3 PUFA) and low-dose aspirin (ASA']","['clinical attachment gain', 'HbA1c levels', 'IFN-γ and IL-8 levels', 'IL-6 levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C4319621', 'cui_str': 'Seventy-five'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}]","[{'cui': 'C1719844', 'cui_str': 'Greek letter omega'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2936227', 'cui_str': 'Nonsurgical Periodontal Debridement'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0032615', 'cui_str': 'Polyunsaturated Fatty Acids'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}]",,0.114601,IFN-γ and IL-8 levels decreased over time for both test groups.,"[{'ForeName': 'Nidia C', 'Initials': 'NC', 'LastName': 'Castro Dos Santos', 'Affiliation': 'Division of Periodontics, Unesp - São Paulo State University, Institute of Science and Technology, São José dos Campos, São Paulo, Brazil.'}, {'ForeName': 'Naira M R B', 'Initials': 'NMRB', 'LastName': 'Andere', 'Affiliation': 'Division of Periodontics, Unesp - São Paulo State University, Institute of Science and Technology, São José dos Campos, São Paulo, Brazil.'}, {'ForeName': 'Cássia F', 'Initials': 'CF', 'LastName': 'Araujo', 'Affiliation': 'Division of Periodontics, Unesp - São Paulo State University, Institute of Science and Technology, São José dos Campos, São Paulo, Brazil.'}, {'ForeName': 'Andrea C', 'Initials': 'AC', 'LastName': 'de Marco', 'Affiliation': 'Division of Periodontics, Unesp - São Paulo State University, Institute of Science and Technology, São José dos Campos, São Paulo, Brazil.'}, {'ForeName': 'Alpdogan', 'Initials': 'A', 'LastName': 'Kantarci', 'Affiliation': 'Center for Clinical and Translational Research, The Forsyth Institute, Cambridge, MA, USA.'}, {'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Van Dyke', 'Affiliation': 'Center for Clinical and Translational Research, The Forsyth Institute, Cambridge, MA, USA.'}, {'ForeName': 'Mauro P', 'Initials': 'MP', 'LastName': 'Santamaria', 'Affiliation': 'Division of Periodontics, Unesp - São Paulo State University, Institute of Science and Technology, São José dos Campos, São Paulo, Brazil.'}]",Journal of periodontology,['10.1002/JPER.19-0613']
983,31350701,Intraoperative continuous renal replacement therapy during liver transplantation: a pilot randomized-controlled trial (INCEPTION).,"PURPOSE


To evaluate the feasibility of intraoperative continuous renal replacement therapy (IoCRRT) during liver transplantation (LT), in terms of recruitment, protocol adherence, and ascertainment of follow-up.
METHODS


In this pilot randomized open-label controlled trial in adults receiving LT with a Model for End-Stage Liver Disease (MELD) score ≥ 25 and preoperative acute kidney injury (RIFLE - RISK or higher) and/or estimated glomerular filtration rate < 60 mL·min -1 ·1.73 m -2 , patients were randomized to receive IoCRRT or standard of care (SOC). Primary endpoints were feasibility and adverse events. Primary analysis was intention-to-treat (n = 32) and secondary analysis was per-protocol (n = 28).
RESULTS


The trial was stopped early because of slow patient accrual and inadequate funding. Sixty patients were enrolled and 32 (53%) were randomized (n = 15 IoCRRT; n = 17 SOC). Mean (standard deviation) MELD was 36 (8), 81% (n = 26) had cirrhosis; 69% (n = 22) received preoperative RRT; 66% (n = 21) received LT from the intensive care unit. Four patients (n = 2 IoCRRT, n = 2 SOC) did not receive LT post-randomization. Seven patients (41%) allocated to SOC crossed over intraoperatively to IoCRRT. Three patients were lost to follow-up at one year. No adverse events occurred related to IoCRRT. There were no differences in survival at one year (IoCRRT, 71% [n = 10/14] vs SOC, 93% [n = 14/15]; risk ratio, 0.77; 95% confidence interval, 0.54 to 1.1). In the per-protocol analysis (n = 28 received IoCRRT after randomization - n = 20 IoCRRT, n = 8 SOC), one-year survival was 92% and perioperative complications were similar between groups. Only one patient was receiving dialysis one year after LT.
CONCLUSION


In this pilot randomized trial, IoCRRT was feasible and safe with no difference in complications. Crossover rates were high. Despite high preoperative severity of illness, one-year survival was excellent. These data can inform the design of a larger multicentre trial.
TRIAL REGISTRATION


www.clinicalTrials.gov (NCT01575015); registered 12 April, 2012.",2019,"There were no differences in survival at one year (IoCRRT, 71% [n = 10/14] vs SOC, 93% [n = 14/15]; risk ratio, 0.77; 95% confidence interval, 0.54 to 1.1).","['adults receiving LT with a Model for End-Stage Liver Disease (MELD) score ≥ 25 and preoperative acute kidney injury (RIFLE - RISK or higher) and/or estimated glomerular filtration rate', 'liver transplantation (LT', 'liver transplantation', 'Sixty patients were enrolled and 32 (53%) were randomized (n = 15 IoCRRT; n = 17 SOC']","['IoCRRT', 'intraoperative continuous renal replacement therapy (IoCRRT', 'Intraoperative continuous renal replacement therapy', 'preoperative RRT', 'SOC crossed over intraoperatively to IoCRRT', 'IoCRRT or standard of care (SOC']","['survival', 'adverse events', 'feasibility and adverse events', 'Mean (standard deviation', 'perioperative complications', 'cirrhosis']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4048785', 'cui_str': 'MELD score'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C2609414', 'cui_str': 'Acute Renal Injury'}, {'cui': 'C0035611', 'cui_str': 'Rifles'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C3811844'}, {'cui': 'C0023911', 'cui_str': 'Transplantation, Hepatic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C3649547', 'cui_str': 'Continuous renal replacement therapy (procedure)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0010366', 'cui_str': 'Crossing Over, Genetic'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C4545429', 'cui_str': 'Perioperative complication'}, {'cui': 'C1623038', 'cui_str': 'Cirrhosis'}]",60.0,0.431431,"There were no differences in survival at one year (IoCRRT, 71% [n = 10/14] vs SOC, 93% [n = 14/15]; risk ratio, 0.77; 95% confidence interval, 0.54 to 1.1).","[{'ForeName': 'Constantine J', 'Initials': 'CJ', 'LastName': 'Karvellas', 'Affiliation': 'Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta, 2-124E Clinical Science Building, 8440-112 Street, Edmonton, AB, T6G 2B7, Canada.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Taylor', 'Affiliation': 'Department of Anesthesia and Pain Medicine, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Bigam', 'Affiliation': 'Department of Surgery, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Norman M', 'Initials': 'NM', 'LastName': 'Kneteman', 'Affiliation': 'Department of Surgery, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'A M James', 'Initials': 'AMJ', 'LastName': 'Shapiro', 'Affiliation': 'Department of Surgery, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Romanovsky', 'Affiliation': 'Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta, 2-124E Clinical Science Building, 8440-112 Street, Edmonton, AB, T6G 2B7, Canada.'}, {'ForeName': 'R T Noel', 'Initials': 'RTN', 'LastName': 'Gibney', 'Affiliation': 'Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta, 2-124E Clinical Science Building, 8440-112 Street, Edmonton, AB, T6G 2B7, Canada.'}, {'ForeName': 'Derek R', 'Initials': 'DR', 'LastName': 'Townsend', 'Affiliation': 'Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta, 2-124E Clinical Science Building, 8440-112 Street, Edmonton, AB, T6G 2B7, Canada.'}, {'ForeName': 'Glenda', 'Initials': 'G', 'LastName': 'Meeberg', 'Affiliation': 'Department of Surgery, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Timur', 'Initials': 'T', 'LastName': 'Özelsel', 'Affiliation': 'Department of Anesthesia and Pain Medicine, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Bishop', 'Affiliation': 'Department of Anesthesia and Pain Medicine, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Sean M', 'Initials': 'SM', 'LastName': 'Bagshaw', 'Affiliation': 'Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta, 2-124E Clinical Science Building, 8440-112 Street, Edmonton, AB, T6G 2B7, Canada. bagshaw@ualberta.ca.'}]",Canadian journal of anaesthesia = Journal canadien d'anesthesie,['10.1007/s12630-019-01454-0']
984,31925414,Patient Engagement With an Automated Telephone Symptom Management Intervention: Predictors and Outcomes.,"BACKGROUND


Self-management of symptoms related to cancer and its treatment is important for maintaining treatment regimens and improving outcomes.
PURPOSE


To determine factors associated with engagement in a symptom self-management intervention among patients initiating oral anticancer treatment.
METHODS


This secondary analysis included 127 patients randomized to the medication adherence reminder and symptom management intervention in a recently completed trial. Patients were recruited from six Comprehensive Cancer Centers, interviewed at intake, and mailed a Symptom Management Toolkit (Toolkit) with self-care management strategies for 18 symptoms. During eight automated telephone weekly calls, patients were asked to use the Toolkit to manage elevated symptoms. Toolkit use and symptoms were tracked weekly, and generalized linear mixed-effects models were used to determine factors predictive of Toolkit use. General linear modeling was used to relate the Toolkit use during intervention to postintervention symptom severity.
RESULTS


Better cognitive function at intake into the trial and higher symptom burden were predictive of the patients' initial decision to try the Toolkit during Week 1. In subsequent weeks, Toolkit use in the previous week and worsening of symptoms were associated with greater odds of Toolkit use. The extent of Toolkit use modified the relationship between intake and 8 week symptom severity: among patients with higher levels of severity at intake, use of the Toolkit conferred greater benefit at 8 weeks.
CONCLUSIONS


Patients make realistic decisions regarding when to use a self-directed approach to self-management and are likely to use strategies when their symptoms are higher and to forego use once symptoms subside.
CLINICAL TRIAL REGISTRATION


NCT02043184.",2020,"The extent of Toolkit use modified the relationship between intake and 8 week symptom severity: among patients with higher levels of severity at intake, use of the Toolkit conferred greater benefit at 8 weeks.
","['patients with higher levels of severity at intake', '127 patients randomized to the', 'patients initiating oral anticancer treatment', 'Patients were recruited from six Comprehensive Cancer Centers, interviewed at intake, and mailed a Symptom Management Toolkit (Toolkit) with self-care management strategies for 18 symptoms']","['Automated Telephone Symptom Management Intervention', 'medication adherence reminder and symptom management intervention']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C1536570', 'cui_str': 'Symptom management (procedure)'}, {'cui': 'C0036592', 'cui_str': 'Self Care'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1536570', 'cui_str': 'Symptom management (procedure)'}, {'cui': 'C2364172', 'cui_str': 'Medication Adherence'}]",[],127.0,0.0266875,"The extent of Toolkit use modified the relationship between intake and 8 week symptom severity: among patients with higher levels of severity at intake, use of the Toolkit conferred greater benefit at 8 weeks.
","[{'ForeName': 'Alla', 'Initials': 'A', 'LastName': 'Sikorskii', 'Affiliation': 'Department of Psychiatry and Department of Statistics and Probability, Michigan, State University, East Lansing, MI, USA.'}, {'ForeName': 'Charles W', 'Initials': 'CW', 'LastName': 'Given', 'Affiliation': 'College of Nursing, Michigan State University, East Lansing, MI, USA.'}, {'ForeName': 'Barbara A', 'Initials': 'BA', 'LastName': 'Given', 'Affiliation': 'College of Nursing, Michigan State University, East Lansing, MI, USA.'}, {'ForeName': 'Asish', 'Initials': 'A', 'LastName': 'Banik', 'Affiliation': 'Department of Statistics and Probability, Michigan State University, East Lansing, MI, USA.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Krauss', 'Affiliation': 'Department of Internal Medicine, University of Michigan, Ann Arbor, MI, USA.'}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1093/abm/kaz067']
985,15223975,Flexible treatment of gestational diabetes modulated on ultrasound evaluation of intrauterine growth: a controlled randomized clinical trial.,"OBJECTIVES


In order to prevent abnormalities of fetal growth still characterizing pregnancies complicated by Gestational Diabetes (GDM), in the present study we evaluated a therapeutic strategy for GDM based on ultrasound (US) measurement of fetal insulin-sensitive tissues.
METHODS


All GDM women diagnosed before 28th week immediately started diet and self-monitoring of blood glucose; after 2 weeks they were randomized to conventional (C) or modified (M) management. In C the glycemic target (GT) was fixed at 90 fasting/120 post-prandial mg/dl; in M GT varied, according to US measurement of the Abdominal Circumference (AC) centile performed every 2 weeks: 80/100 if AC > or =75th, 100/140 if AC<75th. Therapy was tailored to mean fasting (FG) and postprandial glycemia (PPG).
RESULTS


Globally, 229 women completed the study, 78 in C, 151 in M. Use of insulin was 16.7% in C, 30.4% in M (total groups), significantly more frequent in M than in C (59.7% vs 15.4%) when considering only women with AC > or =75th c. Mean metabolic data were similar in the 2 groups, but in M a tightly-optimized subgroup, resulting from the lowering of GT due to AC > or =75th, coexisted with a less-controlled one, whose higher GT was justified by AC<75th. Pregnancy outcome was better in M, with lower (p<0.05*) rate of LGA* (7.9% vs 17.9%), SGA (6.0% vs 9.0%) and Macrosomia* (3.3% vs 11.5%).
CONCLUSIONS


Our data show the value of a flexible US-based approach to the treatment of GDM. This model does not necessarily involve a generalized aggressive treatment, allowing to concentrate therapeutical efforts on a small subgroup of women showing indirect US evidence of fetal hyperinsulinization. Such a selective approach allowed to obtain a near-normalization of fetal growth, with clear advantages on global pregnancy outcome.",2004,"Pregnancy outcome was better in M, with lower (p<0.05*) rate of LGA* (7.9% vs 17.9%), SGA (6.0% vs 9.0%) and Macrosomia* (3.3% vs 11.5%).
","['All GDM women diagnosed before 28th week immediately started diet and self-monitoring of blood glucose; after 2 weeks they were randomized to', '229 women completed the study, 78 in C, 151 in M. Use of insulin was 16.7% in C, 30.4% in M (total groups']",['conventional (C) or modified (M) management'],"['Macrosomia', 'Pregnancy outcome', 'Mean metabolic data', 'mean fasting (FG) and postprandial glycemia (PPG', 'rate of LGA', 'SGA']","[{'cui': 'C0085207', 'cui_str': 'Diabetes, Pregnancy-Induced'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0005803', 'cui_str': 'Monitoring, Home Blood Glucose'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C4517590', 'cui_str': 'Sixteen point seven'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]","[{'cui': 'C0158915', 'cui_str': 'Birth weight 4500 grams OR more'}, {'cui': 'C0032972', 'cui_str': 'Pregnancy Outcome'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0049716', 'cui_str': 'thioGDP'}]",229.0,0.0384945,"Pregnancy outcome was better in M, with lower (p<0.05*) rate of LGA* (7.9% vs 17.9%), SGA (6.0% vs 9.0%) and Macrosomia* (3.3% vs 11.5%).
","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bonomo', 'Affiliation': ""Diabetes Unit, Interdisciplinary Diabetes and Pregnancy Center, Niguarda Ca' Granda Hospital, Piazza Ospedale Maggiore 3, 20162 Milan, Italy. diabetologia@ospedaleniguarda.it""}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Cetin', 'Affiliation': ''}, {'ForeName': 'M P', 'Initials': 'MP', 'LastName': 'Pisoni', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Faden', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Mion', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Taricco', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Nobile de Santis', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Radaelli', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Motta', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Costa', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Solerte', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Morabito', 'Affiliation': ''}]",Diabetes & metabolism,['10.1016/S1262-3636(07)70114-3']
986,30357395,Kidney Damage Biomarkers and Incident Chronic Kidney Disease During Blood Pressure Reduction: A Case-Control Study.,"Background


Whether the increased incidence of chronic kidney disease (CKD) during intensive systolic blood pressure (SBP) lowering is accompanied by intrinsic kidney injury is unknown.
Objective


To compare changes in kidney damage biomarkers between incident CKD case participants and matched control participants as well as between case participants in the intensive (<120 mm Hg) versus the standard (<140 mm Hg) SBP management groups of SPRINT (Systolic Blood Pressure Intervention Trial).
Design


Nested case-control study within SPRINT.
Setting


Adults with hypertension without baseline kidney disease.
Participants


Case participants (n = 162), who developed incident CKD during trial follow-up (128 in the intensive and 34 in the standard group), and control participants (n = 162) without incident CKD, who were matched on age, sex, race, baseline estimated glomerular filtration rate, and randomization group.
Measurements


9 urinary biomarkers of kidney damage were measured at baseline and at 1 year. Linear mixed-effects models were used to estimate 1-year biomarker changes.
Results


Higher concentrations of urinary albumin, kidney injury molecule-1, and monocyte chemoattractant protein-1 at baseline were significantly associated with greater odds of incident CKD (adjusted odds ratio per doubling: 1.50 [95% CI, 1.14 to 1.98], 1.51 [CI, 1.05 to 2.17], and 1.70 [CI, 1.13 to 2.56], respectively). After 1 year of blood pressure intervention, incident CKD case participants in the intensive group had significantly greater decreases in albumin-creatinine ratio (ACR), interleukin-18, anti-chitinase-3-like protein 1 (YKL-40), and uromodulin than the matched control participants. Compared with case participants in the standard group, those in the intensive group had significantly greater decreases in ACR, β2-microglobulin, α1-microglobulin, YKL-40, and uromodulin.
Limitation


Biomarker measurements were available only at baseline and 1 year.
Conclusion


Incident CKD in the setting of intensive SBP lowering was accompanied by decreases, rather than elevations, in levels of kidney damage biomarkers and thus may reflect benign changes in renal blood flow rather than intrinsic injury.
Primary Funding Source


National Institute for Diabetes and Digestive and Kidney Diseases.",2018,"Higher concentrations of urinary albumin, kidney injury molecule-1, and monocyte chemoattractant protein-1 at baseline were significantly associated with greater odds of incident CKD (adjusted odds ratio per doubling: 1.50 [95% CI, 1.14 to 1.98], 1.51 [CI, 1.05 to 2.17], and 1.70 [CI, 1.13 to 2.56], respectively).","['incident CKD case participants and matched control participants as well as between case participants in the intensive (<120 mm Hg) versus the standard (<140 mm Hg) SBP management groups of SPRINT (Systolic Blood Pressure Intervention Trial', 'Setting\n\n\nAdults with hypertension without baseline kidney disease', 'Participants\n\n\nCase participants (n\xa0= 162), who developed incident CKD during trial follow-up (128 in the intensive and 34 in the standard group), and control participants (n\xa0= 162) without incident CKD, who were matched on age, sex, race, baseline estimated glomerular filtration rate, and randomization group']",[],"['ACR, β2-microglobulin, α1-microglobulin, YKL-40, and uromodulin', 'Measurements\n\n\n9 urinary biomarkers of kidney damage', 'albumin-creatinine ratio (ACR), interleukin-18, anti-chitinase-3-like protein 1 (YKL-40), and uromodulin', 'kidney damage biomarkers', 'Kidney Damage Biomarkers and Incident Chronic Kidney Disease', 'Higher concentrations of urinary albumin, kidney injury molecule-1, and monocyte chemoattractant protein-1']","[{'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0022658', 'cui_str': 'Kidney Diseases'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C3811844'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]",[],"[{'cui': 'C0077918', 'cui_str': 'Uromucoid'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0010957', 'cui_str': 'Damage (morphologic abnormality)'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0383327', 'cui_str': 'Interferon-gamma-Inducing Factor'}, {'cui': 'C3872855', 'cui_str': 'GP-39 Protein'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C2681921', 'cui_str': 'Kidney injury molecule-1'}, {'cui': 'C0128897', 'cui_str': 'Chemokine (C-C Motif) Ligand 2'}]",162.0,0.0481748,"Higher concentrations of urinary albumin, kidney injury molecule-1, and monocyte chemoattractant protein-1 at baseline were significantly associated with greater odds of incident CKD (adjusted odds ratio per doubling: 1.50 [95% CI, 1.14 to 1.98], 1.51 [CI, 1.05 to 2.17], and 1.70 [CI, 1.13 to 2.56], respectively).","[{'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Zhang', 'Affiliation': 'San Francisco Veterans Affairs Medical Center and University of California, San Francisco, San Francisco, California (W.R.Z., M.G.S.).'}, {'ForeName': 'Timothy E', 'Initials': 'TE', 'LastName': 'Craven', 'Affiliation': 'Wake Forest School of Medicine, Winston-Salem, North Carolina (T.E.C.).'}, {'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Malhotra', 'Affiliation': 'University of California, San Diego, La Jolla, and Imperial Valley Family Care Medical Group, El Centro, California (R.M.).'}, {'ForeName': 'Alfred K', 'Initials': 'AK', 'LastName': 'Cheung', 'Affiliation': 'University of Utah, Salt Lake City, Utah (A.K.C.).'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Chonchol', 'Affiliation': 'University of Colorado, Aurora, Colorado (M.C.).'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Drawz', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota (P.D.).'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Sarnak', 'Affiliation': 'Tufts Medical Center, Boston, Massachusetts (M.J.S.).'}, {'ForeName': 'Chirag R', 'Initials': 'CR', 'LastName': 'Parikh', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, Maryland (C.R.P.).'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Shlipak', 'Affiliation': 'San Francisco Veterans Affairs Medical Center and University of California, San Francisco, San Francisco, California (W.R.Z., M.G.S.).'}, {'ForeName': 'Joachim H', 'Initials': 'JH', 'LastName': 'Ix', 'Affiliation': 'University of California, San Diego, La Jolla, and Veterans Affairs San Diego Healthcare System, San Diego, California (J.H.I.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of internal medicine,['10.7326/M18-1037']
987,31937303,Fluid intake-related association between urine output and mortality in acute respiratory distress syndrome.,"BACKGROUND


Acute respiratory distress syndrome (ARDS), a complex response to various insults, has a high mortality rate. As pulmonary edema resulting from increased vascular permeability is a hallmark of ARDS, management of the fluid status, including the urine output (UO) and fluid intake (FI), is essential. However, the relationships between UO, FI, and mortality in ARDS remain unclear. This retrospective study aimed to investigate the interactive associations among UO, FI, and mortality in ARDS.
METHODS


This was a secondary analysis of a prospective randomized controlled trial performed at 10 centers within the ARDS Network of the National Heart, Lung, and Blood Institute research network. The total UO and FI volumes within the 24-h period preceding the trial, the UO to FI ratio (UO/FI), demographic data, biochemical measurements, and other variables from 835 patients with ARDS, 539 survivors, and 296 non-survivors, were analyzed. The associations among UO, FI, the UO/FI, and mortality were assessed using a multivariable logistic regression.
RESULTS


In all 835 patients, an increased UO was significantly associated with decreased mortality when used as a continuous variable (odds ratio [OR]: 0.98, 95% confidence interval [CI]: 0.98-0.99, P = 0.002) and as a quartile variable (OR of Q2 to Q4: 0.69-0.46, with Q1 as reference). To explore the interaction between UO and FI, the UO/FI was calculated, and a cut-off value of 0.5 was detected for the association with mortality. For patients with a UO/FI ≤0.5, an increased UO/FI was significantly associated with decreased mortality (OR: 0.09, 95% CI: 0.03-0.253, P <  0.001); this association was not significant for patients with UO/FI ratios > 0.5 (OR: 1.04, 95% CI: 0.96-1.14, P = 0.281). A significant interaction was observed between UO and the UO/FI. The association between UO and mortality was significant in the subgroup with a UO/FI ≤0.5 (OR: 0.97, 95% CI: 0.96-0.99, P = 0.006), but not in the subgroup with a UO/FI > 0.5.
CONCLUSIONS


The association between UO and mortality was mediated by the UO/FI status, as only patients with low UO/FI ratios benefitted from a higher UO.",2020,"OR: 1.04, 95% CI: 0.96-1.14, P = 0.281).","['10 centers within the ARDS Network of the National Heart, Lung, and Blood Institute research network', 'acute respiratory distress syndrome', '835 patients with ARDS, 539 survivors, and 296 non-survivors', 'Acute respiratory distress syndrome (ARDS']",[],"['UO, FI, the UO/FI, and mortality', 'mortality', 'total UO and FI volumes', 'UO and mortality']","[{'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0035222', 'cui_str': 'ARDS, Human'}, {'cui': 'C1955970', 'cui_str': 'National Heart, Lung, and Blood Institute'}, {'cui': 'C0035168'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]",[],"[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}]",835.0,0.102088,"OR: 1.04, 95% CI: 0.96-1.14, P = 0.281).","[{'ForeName': 'Yanfei', 'Initials': 'Y', 'LastName': 'Shen', 'Affiliation': ""Department of Intensive Care, Zhejiang Hospital, No. 12, Linyin Road, Hangzhou, Zhejiang, 310000, People's Republic of China.""}, {'ForeName': 'Guolong', 'Initials': 'G', 'LastName': 'Cai', 'Affiliation': ""Department of Intensive Care, Zhejiang Hospital, No. 12, Linyin Road, Hangzhou, Zhejiang, 310000, People's Republic of China.""}, {'ForeName': 'Shangzhong', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': ""Department of Intensive Care, Zhejiang Hospital, No. 12, Linyin Road, Hangzhou, Zhejiang, 310000, People's Republic of China.""}, {'ForeName': 'Caibao', 'Initials': 'C', 'LastName': 'Hu', 'Affiliation': ""Department of Intensive Care, Zhejiang Hospital, No. 12, Linyin Road, Hangzhou, Zhejiang, 310000, People's Republic of China.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Yan', 'Affiliation': ""Department of Intensive Care, Zhejiang Hospital, No. 12, Linyin Road, Hangzhou, Zhejiang, 310000, People's Republic of China. yanjingzhejiang@163.com.""}]",Respiratory research,['10.1186/s12931-020-1286-5']
988,31502906,A Comparative Effectiveness Trial of Two Patient-Centered Interventions for Women with Unmet Social Needs: Personalized Support for Progress and Enhanced Screening and Referral.,"Background:  Despite recent widespread acceptance that unmet social needs are critically relevant to health, limited guidance exists about how best to address them in the context of women's health care delivery. We aimed to evaluate two interventions: enhanced screening and referral (ESR), a screening intervention with facilitated referral and follow-up calls, and personalized support for progress (PSP), a community health worker intervention tailored to women's priorities.  Materials and Methods:  Women >18 years were screened for presence of elevated depressive symptoms in three women's health clinics serving primarily Medicaid-eligible patients. If eligible and interested, we enrolled and randomized women to ESR or PSP. Pre- and postintervention assessments were conducted. Primary outcomes were satisfaction, depression, and quality of life (QOL). Planned analyses of subgroup differences were also explored.  Results:  A total of 235 participants were randomized; 54% identified as African American, 19% as White, and 15% as Latina. Participant mean age was 30 years; 77% reported annual incomes below US $20,000/year; and 30% were pregnant at enrollment. Participants in both arms found the interventions satisfactory and improved for depression ( p  < 0.001). There were no differences between groups for the primary outcomes. Subgroups reporting greater improvement in QOL in PSP compared with ESR included participants who at baseline reported anxiety ( p  = 0.05), lack of access to depression treatment ( p  = 0.02), pain ( p  = 0.04), and intimate partner violence ( p  = 0.02).  Conclusions:  Clinics serving women with unmet social needs may benefit from offering PSP or ESR. Distinguishing how best to use these interventions in practice is the next step.",2020,Participants in both arms found the interventions satisfactory and improved for depression ( p  < 0.001).,"['Women with Unmet Social Needs', ""Women >18 years were screened for presence of elevated depressive symptoms in three women's health clinics serving primarily Medicaid-eligible patients"", 'Participant mean age was 30 years; 77% reported annual incomes below US $20,000/year; and 30% were pregnant at enrollment', 'A total of 235 participants were randomized; 54% identified as African American, 19% as White, and 15% as Latina']","[""interventions: enhanced screening and referral (ESR), a screening intervention with facilitated referral and follow-up calls, and personalized support for progress (PSP), a community health worker intervention tailored to women's priorities"", 'ESR or PSP', 'Two Patient-Centered Interventions']","['lack of access to depression treatment', 'depression', 'pain', 'QOL in PSP', 'anxiety', 'satisfaction, depression, and quality of life (QOL', 'intimate partner violence']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0080339', 'cui_str': 'Womens Health'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0025071', 'cui_str': 'Medicaid'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0949335', 'cui_str': 'Latinas'}]","[{'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0549179', 'cui_str': 'Priority (attribute)'}, {'cui': 'C1868193', 'cui_str': 'PSP'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0332268', 'cui_str': 'Lacking (qualifier value)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1868193', 'cui_str': 'PSP'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0034380'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}]",235.0,0.12693,Participants in both arms found the interventions satisfactory and improved for depression ( p  < 0.001).,"[{'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Poleshuck', 'Affiliation': 'Department of Psychiatry, University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Marsha', 'Initials': 'M', 'LastName': 'Wittink', 'Affiliation': 'Department of Psychiatry, University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Hugh F', 'Initials': 'HF', 'LastName': 'Crean', 'Affiliation': 'School of Nursing, University of Rochester, Rochester, New York.'}, {'ForeName': 'Iwona', 'Initials': 'I', 'LastName': 'Juskiewicz', 'Affiliation': 'Department of Psychiatry, University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Bell', 'Affiliation': 'Department of Psychiatry, University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Harrington', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Cerulli', 'Affiliation': 'Department of Psychiatry, University of Rochester Medical Center, Rochester, New York.'}]",Journal of women's health (2002),['10.1089/jwh.2018.7640']
989,32436641,"Ultrarapid lispro lowers postprandial glucose and more closely matches normal physiological glucose response compared to other rapid insulin analogues: A phase 1 randomized, crossover study.","AIMS


To compare the pharmacokinetic (PK) and glucodynamic (GD) characteristics of ultra rapid lispro (URLi; Eli Lilly and Company, Indianapolis, Indiana), Fiasp® (Novo Nordisk, Bagsvaerd, Denmark), Humalog® (Eli Lilly and Company) and NovoRapid® (Novo Nordisk), in patients with type 1 diabetes (T1D).
MATERIALS AND METHODS


This was a randomized, double-blind, four-period, crossover study, conducted in 68 patients with T1D. Patients received the same individualized subcutaneous dose of each study drug immediately prior to a liquid test meal. For comparison, 12 healthy subjects received the same test meal.
RESULTS


URLi had a significantly faster insulin absorption compared to the other insulins tested. Early half-maximal drug concentration was reached 13 minutes after administration of URLi, which was 6 minutes faster than Fiasp, 13 minutes faster than Humalog, and 14 minutes faster than NovoRapid (all P <0.0001). Early insulin exposure was significantly greater and late insulin exposure was reduced after URLi compared to the other insulins. URLi achieved the greatest numerical reduction in postprandial glucose (PPG) at 2 hours post-meal (7 mg/dL vs Fiasp) and was significantly different from Humalog (21 mg/dL) and Novo Rapid (29 mg/dL). Additionally, glucose excursions over the first 3 hours post-meal with URLi were comparable to those in healthy subjects.
CONCLUSIONS


URLi demonstrated the fastest insulin absorption and the greatest numeric PPG-lowering effect compared to the other insulins tested. URLi more closely matched the early physiological glucose control observed in healthy subjects.",2020,URLi achieved the greatest numerical reduction in PPG at 2 hours post-meal (7 mg/dL vs Fiasp) and significant differences to Humalog (21 mg/dL) and Novo Rapid (29 mg/dL).,"['68 patients with T1D. Patients', 'patients with type 1 diabetes (T1D', '12 healthy subjects', 'healthy subjects']","['URLi', 'pharmacokinetics (PK) and glucocodynamics (GD) of URLi, Fiasp®, Humalog®, and NovoRapid®', 'Ultra rapid lispro (URLi']","['Ultra Rapid Lispro Lowers Postprandial Glucose and More Closely Matches Normal Physiological Glucose Response', 'insulin absorption', 'maximal drug concentration', 'glucose excursions', 'postprandial glucose (PPG) control', 'late insulin exposure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0293359', 'cui_str': 'Insulin Lispro'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C4529885', 'cui_str': 'Fiasp'}, {'cui': 'C0528249', 'cui_str': 'Humalog'}, {'cui': 'C0939412', 'cui_str': 'NovoRapid'}]","[{'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0293359', 'cui_str': 'Insulin Lispro'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]",68.0,0.0670366,URLi achieved the greatest numerical reduction in PPG at 2 hours post-meal (7 mg/dL vs Fiasp) and significant differences to Humalog (21 mg/dL) and Novo Rapid (29 mg/dL).,"[{'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Heise', 'Affiliation': 'Profil, Neuss, Germany.'}, {'ForeName': 'Helle', 'Initials': 'H', 'LastName': 'Linnebjerg', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Coutant', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'LaBell', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Zijlstra', 'Affiliation': 'Profil, Neuss, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Kapitza', 'Affiliation': 'Profil, Neuss, Germany.'}, {'ForeName': 'Juliana', 'Initials': 'J', 'LastName': 'Bue-Valleskey', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Qianyi', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Mary Anne', 'Initials': 'MA', 'LastName': 'Dellva', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Leohr', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14094']
990,31501493,Effect of angiotensin II receptor blocker and salt supplementation on short-term blood pressure variability in type 2 diabetes.,"High blood pressure variability (BPV) has been associated with increased cardiovascular (CV) risk. The effect of dietary salt and renin-angiotensin-aldosterone system (RAAS) activity on short-term BPV in type 2 diabetes mellitus (T2DM) is not well characterised. We aimed to determine the effect of dietary salt (sodium chloride, NaCl) supplementation on 24-h mean arterial BPV (24hBPV) during angiotensin II receptor blocker (telmisartan) use and to evaluate the effects of age, sex, plasma renin activity (PRA) and serum aldosterone on 24hBPV. In a randomised, double-blind, crossover study, patients with T2DM (n = 28), treated with telmisartan received NaCl (100 mmol/24 h) or placebo capsules during 2 weeks of telmisartan. Following a 6-week washout, the protocol was repeated in reverse. 24hBPV was evaluated as a co-efficient of variation [CV (%) = mean/standard deviation] × 100). Twenty-four hour urinary sodium excretion, ambulatory BP and biochemical tests were performed at each phase. Results were analysed using a linear mixed model to generate predicted values for 24hBPV. Predicted 24hBPV was higher with telmisartan vs baseline (p = 0.01), with a trend towards reduced 24hBPV with salt (p = 0.052). Predicted 24hBPV was lower in females (p = 0.017), increasing age (p = 0.001) and increasing PRA (p = 0.011). In patients with T2DM, predicted 24hBPV increased from baseline with telmisartan, but there was no additional increase in predicted 24hBPV with salt supplementation. This suggests that in the short-term, salt supplementation has no apparent deleterious effects on 24hBPV. Long-term studies are required to evaluate the effect of 24hBPV on CV outcomes in patients with T2DM.",2020,"Predicted 24hBPV was lower in females (p = 0.017), increasing age (p = 0.001) and increasing PRA (p = 0.011).","['patients with T2DM (n\u2009=\u200928), treated with', 'type 2 diabetes', 'type 2 diabetes mellitus (T2DM', 'patients with T2DM']","['telmisartan', 'telmisartan received NaCl', '24hBPV', 'dietary salt (sodium chloride, NaCl) supplementation', 'placebo', 'angiotensin II receptor blocker and salt supplementation', 'angiotensin II receptor blocker (telmisartan', 'dietary salt and renin-angiotensin-aldosterone system (RAAS) activity']","['urinary sodium excretion, ambulatory BP and biochemical tests', 'Predicted 24hBPV', 'cardiovascular (CV) risk', '24hBPV', 'CV outcomes', 'High blood pressure variability (BPV', 'short-term blood pressure variability', 'PRA', '24-h mean arterial BPV (24hBPV']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}]","[{'cui': 'C0248719', 'cui_str': 'telmisartan'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0521942', 'cui_str': 'Angiotensin II Receptor Blockers'}, {'cui': 'C0086907', 'cui_str': 'Renin-Angiotensin-Aldosterone System'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]","[{'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0020538', 'cui_str': 'Blood Pressure, High'}, {'cui': 'C0531207', 'cui_str': 'bpV(phen)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}]",,0.0546638,"Predicted 24hBPV was lower in females (p = 0.017), increasing age (p = 0.001) and increasing PRA (p = 0.011).","[{'ForeName': 'Angela X', 'Initials': 'AX', 'LastName': 'Chen', 'Affiliation': 'Department of Endocrinology, Austin Health, Melbourne, VIC, Australia.'}, {'ForeName': 'John L', 'Initials': 'JL', 'LastName': 'Moran', 'Affiliation': 'Queen Elizabeth Hospital, Adelaide, SA, Australia.'}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Libianto', 'Affiliation': 'Department of Endocrinology, Austin Health, Melbourne, VIC, Australia.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Baqar', 'Affiliation': 'Department of Endocrinology, Austin Health, Melbourne, VIC, Australia.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': ""O'Callaghan"", 'Affiliation': 'Department of Medicine, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'MacIsaac', 'Affiliation': 'Department of Medicine, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Jerums', 'Affiliation': 'Department of Medicine, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Elif I', 'Initials': 'EI', 'LastName': 'Ekinci', 'Affiliation': 'Department of Endocrinology, Austin Health, Melbourne, VIC, Australia. elif.ekinci@unimelb.edu.au.'}]",Journal of human hypertension,['10.1038/s41371-019-0238-3']
991,31345677,Multiple vs Single Target Vegetable Exposure to Increase Young Children's Vegetable Intake.,"OBJECTIVE


To evaluate the effectiveness of repeated exposure to multiple vs single target vegetables in increasing young children's vegetable intake.
METHODS


A pilot randomized controlled trial (children aged 4-6 years, n = 32) was conducted, which exposed children at home 15 times over 5 weeks to either 1 (single target) or 3 (multiple target) vegetables. A comparison group did not change eating habits. Vegetable intake was measured by (1) a dinner meal consumed at research facilities, (2) 3-day weighed food records, and (3) usual vegetable intake (parent report). Measures were collected at baseline and either immediately after intervention (1), at 3-month follow-up (3) or both (2).
RESULTS


There were no differences between groups at baseline in vegetable intake. Usual vegetable intake increased in the multiple target group from .6 to 1.2 servings/d and did not change in other groups (P = .02). Food record data were not significant but underpowered. Vegetable intake from dinner meals was not significantly different between groups.
CONCLUSIONS AND IMPLICATIONS


Exposure to multiple vegetables simultaneously may be more effective than a single vegetable to increase young children's intake. Larger scale research is recommended to confirm the effectiveness of offering variety in exposure and to enhance the understanding of the mechanisms involved.",2019,Usual vegetable intake increased in the multiple target group from .6 to 1.2 servings/d and did not change in other groups (P = .02).,"[""young children's vegetable intake"", 'children aged 4-6 years, n\u202f=\u202f32']",['Multiple vs Single Target Vegetable Exposure'],"['change eating habits', 'vegetable intake', 'Vegetable intake', 'Usual vegetable intake']","[{'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0556223', 'cui_str': 'Vegetable intake (observable entity)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1266864', 'cui_str': 'Eating habit'}, {'cui': 'C0556223', 'cui_str': 'Vegetable intake (observable entity)'}]",,0.0530548,Usual vegetable intake increased in the multiple target group from .6 to 1.2 servings/d and did not change in other groups (P = .02).,"[{'ForeName': 'Astrid A M', 'Initials': 'AAM', 'LastName': 'Poelman', 'Affiliation': 'CSIRO Agriculture & Food, Sensory, Flavour and Consumer Science, North Ryde, Australia; Wageningen University, Division of Human Nutrition,Wageningen, The Netherlands. Electronic address: astrid.poelman@csiro.au.'}, {'ForeName': 'Conor M', 'Initials': 'CM', 'LastName': 'Delahunty', 'Affiliation': 'CSIRO Agriculture & Food, Sensory, Flavour and Consumer Science, North Ryde, Australia.'}, {'ForeName': 'Maeva', 'Initials': 'M', 'LastName': 'Broch', 'Affiliation': 'CSIRO Agriculture & Food, Sensory, Flavour and Consumer Science, North Ryde, Australia.'}, {'ForeName': 'Cees', 'Initials': 'C', 'LastName': 'de Graaf', 'Affiliation': 'Wageningen University, Division of Human Nutrition,Wageningen, The Netherlands.'}]",Journal of nutrition education and behavior,['10.1016/j.jneb.2019.06.009']
992,30962103,"A phase 1, randomized double-blind, placebo controlled trial to evaluate safety and efficacy of epigallocatechin-3-gallate and cognitive training in adults with Fragile X syndrome.","BACKGROUND & AIMS


Despite the wide spectrum of experimental compounds tested in clinical trials, there is still no proven pharmacological treatment available for Fragile-X syndrome (FXS), since several targeted clinical trials with high expectations of success have failed to demonstrate significant improvements. Here we tested epigallocatechin-3-gallate (EGCG) as a treatment option for ameliorating core cognitive and behavioral features in FXS.
METHODS


We conducted preclinical studies in Fmr1 knockout mice (Fmr1-/y) using novel object-recognition memory paradigm upon acute EGCG (10 mg/kg) administration. Furthermore we conducted a double-blind placebo-controlled phase I clinical trial (TESXF; NCT01855971). Twenty-seven subjects with FXS (18-55 years) were administered of EGCG (5-7 mg/kg/day) combined with cognitive training (CT) during 3 months with 3 months of follow-up after treatment discontinuation.
RESULTS


Preclinical studies showed an improvement in memory using the Novel Object Recognition paradigm. We found that FXS patients receiving EGCG + CT significantly improved cognition (visual episodic memory) and functional competence (ABAS II-Home Living skills) in everyday life compared to subjects receiving Placebo + CT.
CONCLUSIONS


Phase 2 clinical trials in larger groups of subjects are necessary to establish the therapeutic potential of EGCG for the improvement of cognition and daily life competences in FXS.",2020,"We found that FXS patients receiving EGCG + CT significantly improved cognition (visual episodic memory) and functional competence (ABAS II-Home Living skills) in everyday life compared to subjects receiving Placebo + CT.
","['Twenty-seven subjects with FXS (18-55 years', 'adults with Fragile X syndrome']","['placebo', 'EGCG\xa0+\xa0CT', 'Placebo', 'epigallocatechin-3-gallate (EGCG', 'epigallocatechin-3-gallate and cognitive training', 'cognitive training (CT', 'EGCG']","['safety and efficacy', 'cognition (visual episodic memory) and functional competence (ABAS II-Home Living skills) in everyday life']","[{'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0016667', 'cui_str': 'X-Linked Mental Retardation and Macroorchidism'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0059438', 'cui_str': 'epigallocatechin gallate'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0561843', 'cui_str': 'Autobiographical Memory'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0376558', 'cui_str': 'Life'}]",27.0,0.363616,"We found that FXS patients receiving EGCG + CT significantly improved cognition (visual episodic memory) and functional competence (ABAS II-Home Living skills) in everyday life compared to subjects receiving Placebo + CT.
","[{'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'de la Torre', 'Affiliation': 'IMIM-Hospital del Mar Medical Research Institute, E-08003 Barcelona, Spain; CIBER of Physiopathology of Obesity and Nutrition (CIBEROBN), E-08003 Barcelona, Spain; University Pompeu Fabra (CEXS-UPF), E-08003 Barcelona, Spain. Electronic address: rtorre@imim.es.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'de Sola', 'Affiliation': 'IMIM-Hospital del Mar Medical Research Institute, E-08003 Barcelona, Spain; CIBER of Physiopathology of Obesity and Nutrition (CIBEROBN), E-08003 Barcelona, Spain.'}, {'ForeName': 'Magí', 'Initials': 'M', 'LastName': 'Farré', 'Affiliation': 'Autonomous University of Barcelona (UDIMAS-UAB), E-08003 Barcelona, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Xicota', 'Affiliation': 'IMIM-Hospital del Mar Medical Research Institute, E-08003 Barcelona, Spain; CIBER of Physiopathology of Obesity and Nutrition (CIBEROBN), E-08003 Barcelona, Spain.'}, {'ForeName': 'Aida', 'Initials': 'A', 'LastName': 'Cuenca-Royo', 'Affiliation': 'IMIM-Hospital del Mar Medical Research Institute, E-08003 Barcelona, Spain; CIBER of Physiopathology of Obesity and Nutrition (CIBEROBN), E-08003 Barcelona, Spain.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Rodriguez', 'Affiliation': 'IMIM-Hospital del Mar Medical Research Institute, E-08003 Barcelona, Spain; CIBER of Physiopathology of Obesity and Nutrition (CIBEROBN), E-08003 Barcelona, Spain.'}, {'ForeName': 'Alba', 'Initials': 'A', 'LastName': 'León', 'Affiliation': 'Neurofunctionality of Brain and Language Research Group-Neurosciences Program, IMIM-Hospital del Mar Medical Research Institute, E-08003 Barcelona, Spain.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Langohr', 'Affiliation': 'IMIM-Hospital del Mar Medical Research Institute, E-08003 Barcelona, Spain; Polytechnic University of Catalonia, E-08034 Barcelona, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Gomis-González', 'Affiliation': 'University Pompeu Fabra (CEXS-UPF), E-08003 Barcelona, Spain.'}, {'ForeName': 'Gimena', 'Initials': 'G', 'LastName': 'Hernandez', 'Affiliation': 'IMIM-Hospital del Mar Medical Research Institute, E-08003 Barcelona, Spain; CIBER of Physiopathology of Obesity and Nutrition (CIBEROBN), E-08003 Barcelona, Spain.'}, {'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Esteba', 'Affiliation': ""Parc Hospitalari Martí í Julià-Institut d'Assistència Sanitària, E-17190 Salt, Spain.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Del Hoyo', 'Affiliation': 'IMIM-Hospital del Mar Medical Research Institute, E-08003 Barcelona, Spain; CIBER of Physiopathology of Obesity and Nutrition (CIBEROBN), E-08003 Barcelona, Spain.'}, {'ForeName': 'Júdit', 'Initials': 'J', 'LastName': 'Sánchez-Gutiérrez', 'Affiliation': 'Fundació Privada Espai Salut, Corporación Fisiogestión, E-08009 Barcelona, Spain.'}, {'ForeName': 'Maria José', 'Initials': 'MJ', 'LastName': 'Cortés', 'Affiliation': 'Intellectual Disabilities and Developmental Disorders Research Unit (UNIVIDD), Fundació Villablanca, IISPV, URV, CIBERSAM, E-43206, Reus, Spain.'}, {'ForeName': 'Andrés', 'Initials': 'A', 'LastName': 'Ozaita', 'Affiliation': 'University Pompeu Fabra (CEXS-UPF), E-08003 Barcelona, Spain.'}, {'ForeName': 'Josep María', 'Initials': 'JM', 'LastName': 'Espadaler', 'Affiliation': 'Neurofunctionality of Brain and Language Research Group-Neurosciences Program, IMIM-Hospital del Mar Medical Research Institute, E-08003 Barcelona, Spain.'}, {'ForeName': 'Ramón', 'Initials': 'R', 'LastName': 'Novell', 'Affiliation': ""Parc Hospitalari Martí í Julià-Institut d'Assistència Sanitària, E-17190 Salt, Spain.""}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Martínez-Leal', 'Affiliation': 'Intellectual Disabilities and Developmental Disorders Research Unit (UNIVIDD), Fundació Villablanca, IISPV, URV, CIBERSAM, E-43206, Reus, Spain.'}, {'ForeName': 'Montserrat', 'Initials': 'M', 'LastName': 'Milá', 'Affiliation': 'Biochemistry and Molecular Genetics Department, Hospital Clínic I Provincial de Barcelona, E-08036, Spain.'}, {'ForeName': 'Mara', 'Initials': 'M', 'LastName': 'Dierssen', 'Affiliation': 'IMIM-Hospital del Mar Medical Research Institute, E-08003 Barcelona, Spain; University Pompeu Fabra (CEXS-UPF), E-08003 Barcelona, Spain; Center for Genomic Regulation (CRG), E-08003 Barcelona, Spain; CIBER of Rare Diseases (CIBERER), E-08003 Barcelona, Spain; The Barcelona Institute of Science and Technology, E-08003 Barcelona, Spain. Electronic address: mara.dierssen@crg.eu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2019.02.028']
993,32439135,"Effect of supportive counseling on pregnancy-specific stress, general stress, and prenatal health behaviors: A multicenter randomized controlled trial.","OBJECTIVE


The aim of this study was to investigate the effects of group supportive counseling (SC) on pregnancy-specific stress, general stress, and healthy behavior of pregnant women.
METHODS


This randomized controlled trial study was conducted on 80 pregnant women in two groups; SC for six sessions, once a week for two hours (n = 40), and antenatal usual care (AUC) (n = 40). All Participants completed questionnaires measuring pregnancy-specific stress, state anxiety, prenatal health behaviors, perceived stress, and provided a saliva sample for measurement of cortisol at pre-intervention and 6-week post-intervention.
RESULTS


The post-intervention results indicated that the outcome scores decreased more significantly in group SC than in the AUC for total NuPDQ, for state-anxiety, for PSS-14, and for unhealthy behaviors with a large effect size. Also, healthy behaviors were promoted more significantly in SC group than in AUC. However, salivary cortisol levels did not differ between group SC and AUC groups.
CONCLUSION


Group supportive counselling can promote pregnancy stress and healthy behaviors.
PRACTICE IMPLICATIONS


Addition of supportive counseling to prenatal usual care may be suggested for pregnant women with any gestational age who seek methods for improving pregnancy stress and healthy behaviors.",2020,"The post-intervention results indicated that the outcome scores decreased more significantly in group SC than in the AUC for total NuPDQ, for state-anxiety, for PSS-14, and for unhealthy behaviors with a large effect size.","['pregnant women with any gestational age', '80 pregnant women in two groups', 'pregnant women']","['group supportive counseling (SC', 'antenatal usual care (AUC', 'SC', 'supportive counseling']","['pregnancy stress and healthy behaviors', 'pregnancy-specific stress, general stress, and healthy behavior', 'total NuPDQ, for state-anxiety', 'pregnancy-specific stress, general stress, and prenatal health behaviors', 'salivary cortisol levels', 'questionnaires measuring pregnancy-specific stress, state anxiety, prenatal health behaviors, perceived stress, and provided a saliva sample for measurement of cortisol', 'healthy behaviors']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3697360', 'cui_str': 'Supportive counseling'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}]","[{'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C1321108', 'cui_str': 'Prenatal health behavior'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]",80.0,0.0769546,"The post-intervention results indicated that the outcome scores decreased more significantly in group SC than in the AUC for total NuPDQ, for state-anxiety, for PSS-14, and for unhealthy behaviors with a large effect size.","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Esfandiari', 'Affiliation': 'Student Research Committee, Babol University of Medical Sciences, Babol, Iran. Electronic address: maryeikimm@gmail.com.'}, {'ForeName': 'Mahbobeh', 'Initials': 'M', 'LastName': 'Faramarzi', 'Affiliation': 'Infertility and Reproductive Health Research Center, Health Research Institute, Babol University of Medical Sciences, Babol, Iran. Electronic address: mahbob330@yahoo.com.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Nasiri-Amiri', 'Affiliation': 'Infertility and Reproductive Health Research Center, Health Research Institute, Babol University of Medical Sciences, Babol, IR Iran. Electronic address: nasiri_fa@yahoo.com.'}, {'ForeName': 'Hadi', 'Initials': 'H', 'LastName': 'Parsian', 'Affiliation': 'Cellular and Molecular Biology Research Center, Health Research Institute, Babol University of Medical Sciences, Babol, Iran. Electronic address: hadiparsian@yahoo.com.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Chehrazi', 'Affiliation': 'Department of Biostatistics and Epidemiology, School of Public Health, Babol University of Medical Sciences, Babol, Iran. Electronic address: mohamadchehrazi@gmail.com.'}, {'ForeName': 'Hajar', 'Initials': 'H', 'LastName': 'Pasha', 'Affiliation': 'Infertility and Reproductive Health Research Center, Health Research Institute, Babol University of Medical Sciences, Babol, Iran. Electronic address: dhajarpasha@gmail.com.'}, {'ForeName': 'Shabnam', 'Initials': 'S', 'LastName': 'Omidvar', 'Affiliation': 'Infertility and Reproductive Health Research Center, Health Research Institute, Babol University of Medical Sciences, Babol, Iran. Electronic address: shomidvar@yahoo.com.'}, {'ForeName': 'Hemmat', 'Initials': 'H', 'LastName': 'Gholinia', 'Affiliation': 'Social Determinants of Health Research Center, Health Research Institute, Babol University of Medical Sciences, Babol, Iran. Electronic address: h_gholonia@yahoo.com.'}]",Patient education and counseling,['10.1016/j.pec.2020.04.024']
994,32436612,"Safety, feasibility and efficacy of side-alternating vibration therapy on bone and muscle health in children and adolescents with musculoskeletal disorders: A pilot trial.","AIMS


A pilot study was performed to establish the safety, feasibility and efficacy of vibration therapy (VT) on bone and muscle health in children and adolescents with a range of musculoskeletal disorders.
METHODS


Seventeen participants (15.7 years ± 2.9 years), with conditions that impacted on their musculoskeletal health, completed 20 weeks of side-alternating VT for 9 min/session, 4 times/week at 20 Hz. Data were collected at baseline and after 20 weeks of intervention. Assessments included whole-body dual-energyX-ray absorptiometry, muscle function (force plate) and 6-min walk test.
RESULTS


Compliance with the prescribed VT training protocol was relatively high overall at 78% and there were no adverse events reported. After 20 weeks intervention, functional assessments showed time taken to perform the chair test was reduced by 15% (P = 0.018), leg balance improved with standard ellipse area decreasing by 88% (P = 0.006) and distance walked in the 6-min walk test improved by 9% (P = 0.002). Participants displayed increased total body mass (1.94 kg; P = 0.018) with increased lean mass (1.20 kg; P = 0.019) but not fat mass (P = 0.19). There was no change in total body bone mineral density (P = 0.44) or bone mineral content (P = 0.07).
CONCLUSIONS


Twenty weeks of side-alternating VT was a feasible protocol that was associated with improvements in physical function and no detrimental effects on lean mass, bone mass or density in children and adolescents with musculoskeletal disorders.",2020,Participants displayed increased total body mass (1.94 kg; P = 0.018) with increased lean mass (1.20 kg; P = 0.019) but not fat mass (P = 0.19).,"['Seventeen participants (15.7\u2009years\u2009±\u20092.9\u2009years), with conditions that impacted on their musculoskeletal health, completed 20\u2009weeks of side-alternating VT for 9 min/session, 4 times/week at 20\u2009Hz', 'children and adolescents with a range of musculoskeletal disorders', 'children and adolescents with musculoskeletal disorders']","['vibration therapy (VT', 'side-alternating vibration therapy']","['lean mass, bone mass or density', 'physical function', 'whole-body dual-energyX-ray absorptiometry, muscle function (force plate) and 6-min walk test', 'lean mass', 'distance walked in the 6-min walk test', 'total body mass', 'time taken to perform the chair test', 'safety, feasibility and efficacy', 'Safety, feasibility and efficacy', 'bone mineral content', 'bone and muscle health', 'total body bone mineral density', 'leg balance']","[{'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517641', 'cui_str': '2.9'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0456698', 'cui_str': 'times/week'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0026857', 'cui_str': 'Disorder of musculoskeletal system'}]","[{'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332270', 'cui_str': 'Alternating'}]","[{'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0086894', 'cui_str': 'Rajiformes'}, {'cui': 'C0231484', 'cui_str': 'Muscle function'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0005963', 'cui_str': 'Bone Mineral Content'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}]",17.0,0.0430062,Participants displayed increased total body mass (1.94 kg; P = 0.018) with increased lean mass (1.20 kg; P = 0.019) but not fat mass (P = 0.19).,"[{'ForeName': 'Renuka M', 'Initials': 'RM', 'LastName': 'Vesey', 'Affiliation': 'Liggins Institute, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Paul L', 'Initials': 'PL', 'LastName': 'Hofman', 'Affiliation': 'Liggins Institute, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'José Gb', 'Initials': 'JG', 'LastName': 'Derraik', 'Affiliation': 'Liggins Institute, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Patrícia', 'Initials': 'P', 'LastName': 'Colle', 'Affiliation': 'Liggins Institute, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Janene B', 'Initials': 'JB', 'LastName': 'Biggs', 'Affiliation': 'Liggins Institute, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Craig F', 'Initials': 'CF', 'LastName': 'Munns', 'Affiliation': ""Endocrinology Department, The Children's Hospital at Westmead, Sydney, New South Wales, Australia.""}, {'ForeName': 'Wayne S', 'Initials': 'WS', 'LastName': 'Cutfield', 'Affiliation': 'Liggins Institute, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Silmara', 'Initials': 'S', 'LastName': 'Gusso', 'Affiliation': 'Liggins Institute, University of Auckland, Auckland, New Zealand.'}]",Journal of paediatrics and child health,['10.1111/jpc.14913']
995,31503408,A texting-based blood pressure surveillance intervention.,"The authors examined whether using home BP measurements collected via a custom-built bi-directional-texting platform incorporated into patients' electronic medical records would lead to treatment calibration and improved BP management. Patients were randomized to either the intervention group and collected home measurements based on reminders and reported via bi-directional texting, or to the control group, with home BP measurement reporting via standard practice (eg, phone, electronic medical record portal) and instructed to return 7 morning and 7 evening BP measurements. Outcomes included number of BP measurements submitted, the number of medication changes, reduction in BP, and BP control. 72% of the intervention group submitted at least 14 readings, compared with 45% of the control group. BP control improved in both groups. However, the authors found no statistically significant difference in BP or the number of BP-medication changes at 1, 3, or 6 months compared with the control group.",2019,BP control improved in both groups.,[],"['intervention group and collected home measurements based on reminders and reported via bi-directional texting, or to the control group, with home BP measurement reporting via standard practice (eg, phone, electronic medical record portal) and instructed to return 7 morning and 7 evening BP measurements', 'A texting-based blood pressure surveillance intervention']","['number of BP measurements submitted, the number of medication changes, reduction in BP, and BP control', 'BP or the number of BP-medication changes', 'BP control']",[],"[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C2362543', 'cui_str': 'Electronic Medical Record'}, {'cui': 'C0205054', 'cui_str': 'Portal (qualifier value)'}, {'cui': 'C0332170', 'cui_str': 'Morning (qualifier value)'}, {'cui': 'C0587117', 'cui_str': 'Evening (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0733511', 'cui_str': 'Surveillance (regime/therapy)'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0580105', 'cui_str': 'Change of medication'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",7.0,0.0398183,BP control improved in both groups.,"[{'ForeName': 'Roula S', 'Initials': 'RS', 'LastName': 'Zahr', 'Affiliation': 'Department of Internal Medicine, Oregon Health Sciences University, Portland, OR, USA.'}, {'ForeName': 'Chris A', 'Initials': 'CA', 'LastName': 'Anthony', 'Affiliation': 'Department of Orthopaedic Surgery, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Philip M', 'Initials': 'PM', 'LastName': 'Polgreen', 'Affiliation': 'Department of Internal Medicine, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Jacob E', 'Initials': 'JE', 'LastName': 'Simmering', 'Affiliation': 'Department of Internal Medicine, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Goerdt', 'Affiliation': 'Department of Internal Medicine, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Angela B', 'Initials': 'AB', 'LastName': 'Hoth', 'Affiliation': 'Department of Internal Medicine, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Miller', 'Affiliation': 'Department of Internal Medicine, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Manish', 'Initials': 'M', 'LastName': 'Suneja', 'Affiliation': 'Department of Internal Medicine, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Alberto M', 'Initials': 'AM', 'LastName': 'Segre', 'Affiliation': 'Department of Computer Science, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Barry L', 'Initials': 'BL', 'LastName': 'Carter', 'Affiliation': 'Department of Pharmacy Practice and Science, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Joseph E', 'Initials': 'JE', 'LastName': 'Cavanaugh', 'Affiliation': 'Department of Biostatistics, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Linnea A', 'Initials': 'LA', 'LastName': 'Polgreen', 'Affiliation': 'Department of Pharmacy Practice and Science, University of Iowa, Iowa City, IA, USA.'}]","Journal of clinical hypertension (Greenwich, Conn.)",['10.1111/jch.13674']
996,31114950,The impact of guided instrument insertion during laparoscopy: a randomized study with novices in an optical box trainer.,"BACKGROUND


During laparoscopic operations, the trocars are often out of the viewing field of the laparoscope. Blind insertion of laparoscopic instruments is potentially dangerous especially when they are pointed or hot. A guidance of the instrument to the target point has the potential to improve the safety of instrument insertion.
METHODS


In this study, the effect of a mechanical and an optical tool for guided instrument insertion into the abdominal cave was evaluated. The controlled prospective randomized study measured safety and efficiency of instrument insertion by 60 novices in an inanimate standardized box trainer. A post-test questionnaire based on the NASA Task Load Index prompted for the subjective impressions of the subjects.
RESULTS


Instrument insertion with optical guidance showed a shorter (p = 0.002) insertion time (median 87.5 s for nine insertions) compared with blind insertion (median 112.0 s for nine insertions). The error number with optical guidance (median 0.5) was lower (p = 0.064) compared with blind insertion (median 1.0). The mechanical guidance showed a shorter (p = 0.001) insertion time (median 89.0 s for nine insertions) and less (p = 0.044) touch errors (median 0) compared with blind insertion. The results of the two guidance tools (mechanical vs. optical guidance) showed no significant difference. In the questionnaire, 89% of the novices subjectively judged the mechanical guidance tool better than blind insertion. The assessments of optical compared to mechanical guidance turned out quite similar.
CONCLUSIONS


In the experimental setup, instrument insertion with a guidance tool performed faster and safer compared with blind insertion. The subjective assessments confirmed the benefit of instrument guidance.",2020,The mechanical guidance showed a shorter (p = 0.001) insertion time,['60 novices in an inanimate standardized box trainer'],"['blind insertion', 'guided instrument insertion during laparoscopy']","['error number with optical guidance', 'insertion time']","[{'cui': 'C1638312', 'cui_str': 'Boxes'}, {'cui': 'C0453962', 'cui_str': 'Trainers (physical object)'}]","[{'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C4551823', 'cui_str': 'instruments'}, {'cui': 'C0031150', 'cui_str': 'Celioscopy'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",,0.08425,The mechanical guidance showed a shorter (p = 0.001) insertion time,"[{'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Kunert', 'Affiliation': 'University Department of General, Visceral and Transplant Surgery, Workgroup Surgical Technology and Training, University Hospital Tübingen, Waldhörnlestrasse 22, 72072, Tübingen, Germany.'}, {'ForeName': 'Carolin', 'Initials': 'C', 'LastName': 'Land', 'Affiliation': 'University Department of General, Visceral and Transplant Surgery, Workgroup Surgical Technology and Training, University Hospital Tübingen, Waldhörnlestrasse 22, 72072, Tübingen, Germany.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Braun', 'Affiliation': 'University Department of General, Visceral and Transplant Surgery, Workgroup Surgical Technology and Training, University Hospital Tübingen, Waldhörnlestrasse 22, 72072, Tübingen, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Reichold', 'Affiliation': 'TWT GmbH, Science & Innovation, Ernsthaldenstraße 17, 70565, Stuttgart, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Kirschniak', 'Affiliation': 'University Department of General, Visceral and Transplant Surgery, Workgroup Surgical Technology and Training, University Hospital Tübingen, Waldhörnlestrasse 22, 72072, Tübingen, Germany. andreas.kirschniak@med.uni-tuebingen.de.'}, {'ForeName': 'Claudius', 'Initials': 'C', 'LastName': 'Falch', 'Affiliation': 'University Department of General, Visceral and Transplant Surgery, Workgroup Surgical Technology and Training, University Hospital Tübingen, Waldhörnlestrasse 22, 72072, Tübingen, Germany.'}]",Surgical endoscopy,['10.1007/s00464-019-06829-4']
997,31494820,"Safety and efficacy of Cerebrolysin in acute brain injury and neurorecovery: CAPTAIN I-a randomized, placebo-controlled, double-blind, Asian-Pacific trial.","OBJECTIVE


To evaluate the safety and efficacy of Cerebrolysin as an add-on therapy to local standard treatment protocol in patients after moderate-to-severe traumatic brain injury.
METHODS


The patients received the study medication in addition to standard care (50 mL of Cerebrolysin or physiological saline solution daily for 10 days, followed by two additional treatment cycles with 10 mL daily for 10 days) in a prospective, randomized, double-blind, placebo-controlled, parallel-group, multi-centre phase IIIb/IV trial. The primary endpoint was a multidimensional ensemble of 14 outcome scales pooled to be analyzed by means of the multivariate, correlation-sensitive Wei-Lachin procedure.
RESULTS


In 46 enrolled TBI patients (Cerebrolysin 22, placebo 24), three single outcomes showed stand-alone statistically significant superiority of Cerebrolysin [Stroop Word/Dots Interference (p = 0.0415, Mann-Whitney(MW) = 0.6816, 95% CI 0.51-0.86); Color Trails Tests 1 and 2 (p = 0.0223/0.0170, MW = 0.72/0.73, 95% CI 0.53-0.90/0.54-0.91), both effect sizes lying above the benchmark for ""large"" superiority (MW > 0.71)]. While for the primary multivariate ensemble, statistical significance was just missed in the intention-to-treat population (p Wei-Lachin  < 0.1, MW combined  = 0.63, 95% CI 0.48-0.77, derived standardized mean difference (SMD) 0.45, 95% CI -0.07 to 1.04, derived OR 2.1, 95% CI 0.89-5.95), the per-protocol analysis showed a statistical significant superiority of Cerebrolysin (p Wei-Lachin  = 0.0240, MW combined  = 0.69, 95% CI 0.53 to 0.85, derived SMD 0.69, 95% CI 0.09 to 1.47, derived OR 3.2, 95% CI 1.16 to 12.8), with effect sizes of six single outcomes lying above the benchmark for ""large"" superiority. Safety aspects were comparable to placebo.
CONCLUSION


Our trial suggests beneficial effects of Cerebrolysin on outcome after TBI. Results should be confirmed by a larger RCT with a comparable multidimensional approach.",2020,"Safety aspects were comparable to placebo.
","['patients after moderate-to-severe traumatic brain injury', 'acute brain injury and neurorecovery']","['placebo', 'standard care (50\xa0mL of Cerebrolysin or physiological saline solution', 'Cerebrolysin']","['Safety and efficacy', 'safety and efficacy', 'multidimensional ensemble of 14 outcome scales pooled to be analyzed by means of the multivariate, correlation-sensitive Wei-Lachin procedure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0876926', 'cui_str': 'TBI (Traumatic Brain Injury)'}, {'cui': 'C0085742', 'cui_str': 'Injuries, Acute Brain'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0055108', 'cui_str': 'cerebrolysine'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0222045'}, {'cui': 'C0337051', 'cui_str': 'Pool (environment)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}]",46.0,0.740514,"Safety aspects were comparable to placebo.
","[{'ForeName': 'W', 'Initials': 'W', 'LastName': 'Poon', 'Affiliation': 'Division of Neurosurgery, Prince of Wales Hospital, The Chinese University of Hong Kong, Shatin, Hong Kong, China.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Matula', 'Affiliation': 'Department of Neurosurgery, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'P E', 'Initials': 'PE', 'LastName': 'Vos', 'Affiliation': 'Department of Neurology, Slingeland Hospital, Doetinchem, The Netherlands.'}, {'ForeName': 'D F', 'Initials': 'DF', 'LastName': 'Muresanu', 'Affiliation': 'Department of Clinical Neurosciences, ""Iuliu Hatieganu"" University of Medicine and Pharmacy, Cluj-Napoca, Romania. dafinm@ssnn.ro.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'von Steinbüchel', 'Affiliation': 'Institute of Medical Psychology and Medical Sociology, University Medical Centre Göttingen, Göttingen, Germany.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'von Wild', 'Affiliation': ""Medical Faculty, Westphalia Wilhelm's University, Münster, Germany.""}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Hömberg', 'Affiliation': 'Department of Neurology, SRH Gesundheitszentrum Bad Wimpfen GmbH, Bad Wimpfen, Germany.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Wang', 'Affiliation': 'Department of Neurosurgery, National Neuroscience Institute, Singapore, Singapore.'}, {'ForeName': 'T M C', 'Initials': 'TMC', 'LastName': 'Lee', 'Affiliation': 'State Key Laboratory of Brain and Cognitive Sciences and Laboratory of Neuropsychology, The University of Hong Kong, Pokfulam, Hong Kong, China.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Strilciuc', 'Affiliation': 'Department of Clinical Neurosciences, ""Iuliu Hatieganu"" University of Medicine and Pharmacy, Cluj-Napoca, Romania.'}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Vester', 'Affiliation': 'Department of Biometry and Clinical Research, idv Data Analysis and Study Planning, Krailling, Germany.'}]",Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology,['10.1007/s10072-019-04053-5']
998,31767043,Variation in care for children undergoing the Fontan operation for hypoplastic left heart syndrome.,"BACKGROUND


The Single Ventricle Reconstruction Trial randomised neonates with hypoplastic left heart syndrome to a shunt strategy but otherwise retained standard of care. We aimed to describe centre-level practice variation at Fontan completion.
METHODS


Centre-level data are reported as median or median frequency across all centres and range of medians or frequencies across centres. Classification and regression tree analysis assessed the association of centre-level factors with length of stay and percentage of patients with prolonged pleural effusion (>7 days).
RESULTS


The median Fontan age (14 centres, 320 patients) was 3.1 years (range from 1.7 to 3.9), and the weight-for-age z-score was -0.56 (-1.35 + 0.44). Extra-cardiac Fontans were performed in 79% (4-100%) of patients at the 13 centres performing this procedure; lateral tunnels were performed in 32% (3-100%) at the 11 centres performing it. Deep hypothermic circulatory arrest (nine centres) ranged from 6 to 100%. Major complications occurred in 17% (7-33%). The length of stay was 9.5 days (9-12); 15% (6-33%) had prolonged pleural effusion. Centres with fewer patients (<6%) with prolonged pleural effusion and fewer (<41%) complications had a shorter length of stay (<10 days; sensitivity 1.0; specificity 0.71; area under the curve 0.96). Avoiding deep hypothermic circulatory arrest and higher weight-for-age z-score were associated with a lower percentage of patients with prolonged effusions (<9.5%; sensitivity 1.0; specificity = 0.86; area under the curve 0.98).
CONCLUSIONS


Fontan perioperative practices varied widely among study centres. Strategies to decrease the duration of pleural effusion and minimise complications may decrease the length of stay. Further research regarding deep hypothermic circulatory arrest is needed to understand its association with prolonged pleural effusion.",2019,The length of stay was 9.5 days (9-12); 15% (6-33%) had prolonged pleural effusion.,"['The median Fontan age (14 centres, 320 patients) was 3.1\xa0years (range from 1.7 to 3.9), and the weight-for-age z-score was -0.56 ', 'neonates with hypoplastic left heart syndrome', 'children undergoing the Fontan operation for hypoplastic left heart syndrome', 'patients with prolonged pleural effusion (>7\xa0days']",[],"['shorter length of stay', 'prolonged pleural effusion', 'length of stay', 'duration of pleural effusion', 'Major complications']","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C4517711', 'cui_str': '320 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517683', 'cui_str': '3.1 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C4517512', 'cui_str': '1.7 (qualifier value)'}, {'cui': 'C4517698', 'cui_str': '3.9 (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0152101', 'cui_str': 'Left Heart Hypoplasia Syndrome'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0190010', 'cui_str': 'Norwood Procedure, Stage III'}, {'cui': 'C0032227', 'cui_str': 'Pleural Effusion'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",[],"[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0032227', 'cui_str': 'Pleural Effusion'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",320.0,0.0949982,The length of stay was 9.5 days (9-12); 15% (6-33%) had prolonged pleural effusion.,"[{'ForeName': 'Aaron W', 'Initials': 'AW', 'LastName': 'Eckhauser', 'Affiliation': ""Divisions of Cardiothoracic Surgery and Pediatric Cardiology, University of Utah, Primary Children's Hospital, Salt Lake City, UT, USA.""}, {'ForeName': 'Maria I', 'Initials': 'MI', 'LastName': 'Van Rompay', 'Affiliation': 'New England Research Institutes, Watertown, MA, USA.'}, {'ForeName': 'Chitra', 'Initials': 'C', 'LastName': 'Ravishankar', 'Affiliation': ""Division of Pediatric Cardiology, Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}, {'ForeName': 'Jane W', 'Initials': 'JW', 'LastName': 'Newburger', 'Affiliation': ""Department of Cardiology, Boston Children's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Ram Kumar', 'Affiliation': ""Heart Institute, Children's Hospital of Los Angeles, Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.""}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Pizarro', 'Affiliation': 'Nemours Cardiac Center, Nemours/Alfred I. duPont Hospital for Children, Wilmington, DE, USA.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Ghanayem', 'Affiliation': ""Division of Pediatric Critical Care, Baylor College of Medicine, Texas Children's Hospital, Houston, TX, USA.""}, {'ForeName': 'Felicia L', 'Initials': 'FL', 'LastName': 'Trachtenberg', 'Affiliation': 'New England Research Institutes, Watertown, MA, USA.'}, {'ForeName': 'Kristin M', 'Initials': 'KM', 'LastName': 'Burns', 'Affiliation': 'Division of Cardiovascular Sciences, National Heart, Lung and Blood Institute, Bethesda, MD, USA.'}, {'ForeName': 'Garick D', 'Initials': 'GD', 'LastName': 'Hill', 'Affiliation': ""Division of Cardiology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Atz', 'Affiliation': 'Division of Cardiology, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Michelle S', 'Initials': 'MS', 'LastName': 'Hamstra', 'Affiliation': ""Division of Cardiology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Mjaye', 'Initials': 'M', 'LastName': 'Mazwi', 'Affiliation': 'Department of Critical Care Medicine, Hospital for Sick Children, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Patsy', 'Initials': 'P', 'LastName': 'Park', 'Affiliation': 'Division of Pediatric Cardiology, Duke University, Durham, NC, USA.'}, {'ForeName': 'Marc E', 'Initials': 'ME', 'LastName': 'Richmond', 'Affiliation': 'Division of Pediatric Cardiology, Columbia University College of Physicians & Surgeons, New York, NY, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Wolf', 'Affiliation': 'Division of Pediatric Cardiology, Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Jeffrey D', 'Initials': 'JD', 'LastName': 'Zampi', 'Affiliation': ""Division of Pediatric Cardiology, University of Michigan, C.S. Mott Children's Hospital, Ann Arbor, MI, USA.""}, {'ForeName': 'Jeffrey P', 'Initials': 'JP', 'LastName': 'Jacobs', 'Affiliation': ""Division of Cardiovascular Surgery, Johns Hopkins University and All Children's Hospital, St. Petersburg, FL, USA.""}, {'ForeName': 'L LuAnn', 'Initials': 'LL', 'LastName': 'Minich', 'Affiliation': ""Divisions of Cardiothoracic Surgery and Pediatric Cardiology, University of Utah, Primary Children's Hospital, Salt Lake City, UT, USA.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Cardiology in the young,['10.1017/S1047951119002658']
999,31498113,Impact of ticagrelor monotherapy on two-year clinical outcomes in patients with long stenting: a post hoc analysis of the GLOBAL LEADERS trial.,"AIMS


The aim of this study was to evaluate the impact of a novel antiplatelet regimen in patients with increasing total stent length (TSL).
METHODS AND RESULTS


This is a post hoc analysis of the GLOBAL LEADERS trial, a prospective, multicentre, open-label, randomised trial, investigating the impact of the experimental strategy (one-month dual antiplatelet therapy [DAPT] followed by 23-month ticagrelor monotherapy) versus the reference regimen (12-month DAPT followed by 12-month aspirin monotherapy) in patients with a Biolimus A9-eluting stent (BES). The primary endpoint was the composite of all-cause death and new Q-wave myocardial infarction (MI), and the secondary endpoint was Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding at two years. To investigate the association between total stent length and outcomes, groups were compared in quartiles according to TSL; the fourth quartile group was at significantly higher ischaemic risk at two years. In that stratum (TSL ≥46 mm), the experimental strategy significantly reduced the risk of the primary endpoint (hazard ratio [HR] 0.67, 95% confidence interval [CI]: 0.49-0.90; pinteraction=0.043), while demonstrating a similar risk of BARC type 3 or 5 bleeding (HR 0.99, 95% CI: 0.66-1.49; pinteraction=0.975).
CONCLUSIONS


Ticagrelor monotherapy could potentially balance ischaemic and bleeding risks, thereby achieving a net clinical benefit in patients with a TSL ≥46 mm with a BES.",2020,"In that stratum (TSL≥ 46mm), the experimental strategy significantly reduced the risk of the primary endpoint (hazard ratio [HR]:0.67; 95% confidence interval [CI]:0.49-0.90; Pinteraction=0.043), while demonstrating a similar risk of BARC type 3 or 5 bleeding (HR:0.99; 95% CI:0.66-1.49; Pinteraction =0.975).
","['patients with Biolimus A9-eluting stent (BES', 'patients with increasing total stent length (TSL', 'patients with TSL≥ 46 mm with BES', 'Patients with Long Stenting']","['aspirin monotherapy', 'Ticagrelor Monotherapy', 'ticagrelor monotherapy', 'Ticagrelor monotherapy']","['ischemic risk', 'balance ischemic and bleeding risks', 'composite of the all-cause death and new Q-wave myocardial infarction (MI), and the secondary endpoint was Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4310325', 'cui_str': 'Biolimus A9'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0053353', 'cui_str': 'N,N-bis(2-hydroxyethyl)aminoethanesulfonic acid'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}]","[{'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}]","[{'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1305738', 'cui_str': 'Q wave feature'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0035168'}, {'cui': 'C0441731', 'cui_str': 'Type 3 (qualifier value)'}]",,0.0743589,"In that stratum (TSL≥ 46mm), the experimental strategy significantly reduced the risk of the primary endpoint (hazard ratio [HR]:0.67; 95% confidence interval [CI]:0.49-0.90; Pinteraction=0.043), while demonstrating a similar risk of BARC type 3 or 5 bleeding (HR:0.99; 95% CI:0.66-1.49; Pinteraction =0.975).
","[{'ForeName': 'Kuniaki', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Ply', 'Initials': 'P', 'LastName': 'Chichareon', 'Affiliation': ''}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Modolo', 'Affiliation': ''}, {'ForeName': 'Norihiro', 'Initials': 'N', 'LastName': 'Kogame', 'Affiliation': ''}, {'ForeName': 'Chun Chin', 'Initials': 'CC', 'LastName': 'Chang', 'Affiliation': ''}, {'ForeName': 'Mariusz', 'Initials': 'M', 'LastName': 'Tomaniak', 'Affiliation': ''}, {'ForeName': 'Aris', 'Initials': 'A', 'LastName': 'Moschovitis', 'Affiliation': ''}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Curzen', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Haude', 'Affiliation': ''}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Jung', 'Affiliation': ''}, {'ForeName': 'Lene', 'Initials': 'L', 'LastName': 'Holmvang', 'Affiliation': ''}, {'ForeName': 'Scot', 'Initials': 'S', 'LastName': 'Garg', 'Affiliation': ''}, {'ForeName': 'Jan G P', 'Initials': 'JGP', 'LastName': 'Tijssen', 'Affiliation': ''}, {'ForeName': 'Joanna J', 'Initials': 'JJ', 'LastName': 'Wykrzykowska', 'Affiliation': ''}, {'ForeName': 'Robbert J', 'Initials': 'RJ', 'LastName': 'de Winter', 'Affiliation': ''}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hamm', 'Affiliation': ''}, {'ForeName': 'Philippe Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': ''}, {'ForeName': 'Hans-Peter', 'Initials': 'HP', 'LastName': 'Stoll', 'Affiliation': ''}, {'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Onuma', 'Affiliation': ''}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Valgimigli', 'Affiliation': ''}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Vranckx', 'Affiliation': ''}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': ''}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': ''}]",EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology,['10.4244/EIJ-D-19-00498']
1000,31498467,Role of voice rest following laser resection of vocal fold lesions: A randomized controlled trial.,"OBJECTIVES/HYPOTHESIS


Voice rest is often prescribed following phonosurgery by most surgeons despite limited empiric evidence to support its practice. This study assessed the effect of postphonosurgery voice rest on vocal outcomes.
STUDY DESIGN


Prospective, randomized controlled trial.
METHODS


Patients with unilateral vocal fold lesions undergoing CO 2  laser excision were recruited in a prospective manner and randomized into one of two groups: 1) an experimental arm consisting of 7 days of absolute voice rest, or 2) a control arm consisting of no voice rest. The primary outcome measure was the Voice Handicap Index-10 (VHI-10) questionnaire. Secondary outcomes included aerodynamic measurements (maximum phonation time), acoustic measures (fundamental frequency, jitter, shimmer, and harmonic-to-noise ratio), and auditory-perceptual measures. Primary and secondary outcomes were assessed preoperatively and reassessed postoperatively at the 1- and 3-month follow-up. Patient compliance to voice rest instructions were controlled for using subjective and objective parameters.
RESULTS


Thirty patients were enrolled with 15 randomized to each arm of the study. Statistical analysis for the entire cohort showed a significant improvement in the mean preoperative VHI-10 compared to postoperative assessments at 1-month (19.0 vs. 7.3, P < .05) and 3-month (19.0 vs. 6.2, P < .05) follow-up. However, between-group comparisons showed no significant difference in postoperative VHI-10 at either time point. Similarly, secondary outcome measures yielded no significant difference in between-group comparisons.
CONCLUSIONS


Our study shows no significant benefit to voice rest on postoperative voice outcomes as determined by patient self-perception, acoustic variables, and auditory-perceptual analysis.
LEVEL OF EVIDENCE


1b CLINICAL TRIAL NUMBER: NCT02788435 (clinicaltrials.gov) Laryngoscope, 130:1750-1755, 2020.",2020,"Our study shows no significant benefit to voice rest on postoperative voice outcomes as determined by patient self-perception, acoustic variables, and auditory-perceptual analysis.
","['Thirty patients were enrolled with 15 randomized to each arm of the study', 'Patients with unilateral vocal fold lesions undergoing CO 2  laser excision', 'vocal fold lesions']","['absolute voice rest, or 2) a control arm consisting of no voice rest', 'postphonosurgery voice rest', 'laser resection']","['postoperative VHI-10', 'Voice Handicap Index-10 (VHI-10) questionnaire', 'mean preoperative VHI-10', 'aerodynamic measurements (maximum phonation time), acoustic measures (fundamental frequency, jitter, shimmer, and harmonic-to-noise ratio), and auditory-perceptual measures']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0042930', 'cui_str': 'Vocal Fold'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}]","[{'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C2985106', 'cui_str': 'Voice handicap index (assessment scale)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0234778', 'cui_str': 'Maximum phonation time (observable entity)'}, {'cui': 'C0001166', 'cui_str': 'Acoustics'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}]",30.0,0.185901,"Our study shows no significant benefit to voice rest on postoperative voice outcomes as determined by patient self-perception, acoustic variables, and auditory-perceptual analysis.
","[{'ForeName': 'Sandeep S', 'Initials': 'SS', 'LastName': 'Dhaliwal', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Western University, London, Ontario, Canada.'}, {'ForeName': 'Philip C', 'Initials': 'PC', 'LastName': 'Doyle', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Western University, London, Ontario, Canada.'}, {'ForeName': 'Sebastiano', 'Initials': 'S', 'LastName': 'Failla', 'Affiliation': 'Voice Production and Perception Laboratory, and Department of Health and Rehabilitation Sciences, Western University, London, Ontario, Canada.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Hawkins', 'Affiliation': 'Department of Speech-Language Pathology, London Health Sciences Centre, London, Ontario, Canada.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Fung', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Western University, London, Ontario, Canada.'}]",The Laryngoscope,['10.1002/lary.28287']
1001,31486188,Intensive glucose-lowering and the risk of vascular events and premature death in patients with decreased kidney function: The ADVANCE trial.,"To assess the effects of intensive glucose control on the risk of major clinical outcomes according to estimated glomerular filtration rate (eGFR) levels in people with type 2 diabetes. Of 11 140 ADVANCE trial participants, 11 096 with baseline eGFR measurements were included, and classified into three eGFR groups: ≥90 mL/min/1.73 m 2  ; 60 to 89 mL/min/1.73 m 2  ; and < 60 mL/min/1.73 m 2  . Relative risk reduction of randomized intensive glucose control with regard to the composite outcome of major macro- and microvascular events, all-cause death and cardiovascular death did not significantly vary by eGFR level (P for heterogeneity ≥0.49). The risk of severe hypoglycaemia increased with intensive glucose control; however, this risk did not vary across eGFR groups (P for heterogeneity = 0.83). The risk-benefit profile of intensive glucose control in patients with type 2 diabetes and impaired kidney function appears similar to that observed in those with preserved kidney function.",2020,"The risk of severe hypoglycaemia increased with intensive glucose-control; however, this risk did not vary across eGFR groups (p for heterogeneity=0.83).","['patients with decreased kidney function', 'type 2 diabetes', 'patients with type 2 diabetes', '11,096 participants with baseline eGFR measurements were included, classified into three groups: eGFR ≥90, 60-89, and <60 ml/min/1.73m 2  ']",['intensive glucose-control'],"['Intensive glucose lowering and the risk of vascular events and premature death', 'glomerular filtration rate (eGFR) levels', 'risk of severe hypoglycaemia', 'composite of major macro- and microvascular events, all-cause death, and cardiovascular death', 'kidney function']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0232807', 'cui_str': 'Decreased renal function (finding)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C1855073', 'cui_str': 'Death, Premature'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0443258', 'cui_str': 'Microvascular (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0031843', 'cui_str': 'function'}]",,0.0716984,"The risk of severe hypoglycaemia increased with intensive glucose-control; however, this risk did not vary across eGFR groups (p for heterogeneity=0.83).","[{'ForeName': 'Toshiaki', 'Initials': 'T', 'LastName': 'Ohkuma', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Zoungas', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Jun', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Liu', 'Initials': 'L', 'LastName': 'Lisheng', 'Affiliation': 'The Chinese Hypertension League Institute, Beijing, China.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Mancia', 'Affiliation': 'Istituto Auxologico Italiano, University of Milan-Bicocca, Milan, Italy.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Marre', 'Affiliation': 'Department of Endocrinology, Hopital Bichat-Claude Bernard, University of Paris, Paris, France.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Rodgers', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Williams', 'Affiliation': 'Institute of Cardiovascular Sciences, University College London and National Institute of Health Research UCL Hospitals Biomedical Research Centre, London, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Woodward', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Chalmers', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Diabetes, obesity & metabolism",['10.1111/dom.13878']
1002,31812686,Convergent-Divergent Validity and Correlates of the Day-to-Day Impact of Vaginal Aging Domain Scales in the MsFLASH Vaginal Health Trial.,"INTRODUCTION


Clinical research and management of postmenopausal vaginal symptoms have been limited by the lack of validated measures for assessing symptom impact.
AIM


To evaluate convergent-divergent validity of the Day-to-Day Impact of Vaginal Aging (DIVA) questionnaire among postmenopausal women with moderate-to-severe vulvovaginal symptoms and identify demographic and clinical factors associated with greater symptom impact.
METHODS


We examined baseline data from postmenopausal women with moderate-to-severe vulvovaginal itching, pain, irritation, dryness, or pain with intercourse in a randomized trial of vaginal estradiol, moisturizer, or placebo. In addition to completing the DIVA questionnaire, participants rated the severity of their most bothersome vulvovaginal symptom, underwent assessment of vaginal pH and epithelial cytology, and completed other self-report measures including the Female Sexual Function Index (FSFI), Female Sexual Distress Scale (FSDS), and Patient Health Questionnaire-8 for depression (PHQ-8).
MAIN OUTCOME MEASURE


The main outcome measures were the unadjusted correlations and multivariable-adjusted associations with 4 DIVA domain scales designed to assess symptom impact on day-to-day activities, sexual functioning, emotional well-being, and body image/self-concept on a scale of 0 to 4.
RESULTS


Among 301 women, we detected moderately strong correlations between the DIVA emotional well-being scale and PHQ-8 scores (Pearson correlation coefficient [r] = 0.39) and strong correlations between the DIVA sexual functioning scale and FSFI and FSDS scores (r > 0.50). No significant correlations were detected between any DIVA scales and vaginal pH or epithelial cytology. In adjusted linear-regression analyses, greater vulvovaginal symptom severity was associated with worse DIVA scores for emotional well-being, sexual functioning, and self-concept/body image (average 0.3- to 0.5-point higher DIVA score for each 1-point difference in vulvovaginal symptom severity). Depression symptoms were associated with worse DIVA scores for activities of daily living and emotional well-being (0.2- to 0.4-point higher DIVA score for each 5- point worsening of PHQ-8 score). Women reporting recent sexual activity had lower symptom impact on sexual functioning and self-concept/body image domains (-0.3- to -0.4-point lower DIVA score with weekly sexual activity).
CLINICAL IMPLICATIONS


Findings suggest that the impact of postmenopausal vaginal symptoms on functioning and well-being is greater in women with co-morbid depression symptoms and less frequent sexual activity, independent of symptom severity.
STRENGTHS & LIMITATIONS


Strengths include the multicenter sample and wide array of measures. Results may not generalize to women with mild symptoms.
CONCLUSION


Our results support the construct validity of the DIVA questionnaire for clinical practice and research and indicate that depression and lower frequency of sexual activity are markers of greater impact of postmenopausal vaginal symptoms on multiple dimensions of functioning and quality of life. Hunter MM, Guthrie KA, Larson JC, et al. Convergent-Divergent Validity and Correlates of the Day-to-Day Impact of Vaginal Aging Domain Scales in the MsFLASH Vaginal Health Trial. J Sex Med 2020;17:117-125.",2020,Depression symptoms were associated with worse DIVA scores for activities of daily living and emotional well-being (0.2- to 0.4-point higher DIVA score for each 5- point worsening of PHQ-8 score).,"['postmenopausal women with moderate-to-severe vulvovaginal symptoms', 'women with mild symptoms', '301 women', 'postmenopausal women with moderate-to-severe vulvovaginal itching, pain, irritation, dryness, or pain with intercourse']","['Vaginal Aging (DIVA) questionnaire', 'vaginal estradiol, moisturizer, or placebo']","['DIVA scores for emotional well-being, sexual functioning, and self-concept/body image', 'DIVA sexual functioning scale and FSFI and FSDS scores', 'worse DIVA scores for activities of daily living and emotional well-being', 'severity of their most bothersome vulvovaginal symptom', 'DIVA scales and vaginal pH or epithelial cytology', 'vulvovaginal symptom severity', 'Female Sexual Function Index (FSFI), Female Sexual Distress Scale (FSDS), and Patient Health Questionnaire-8 for depression (PHQ-8', 'symptom impact on day-to-day activities, sexual functioning, emotional well-being, and body image/self-concept on a scale of 0 to\xa04', 'DIVA emotional well-being scale and PHQ-8 scores', 'Depression symptoms']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0441723', 'cui_str': 'Irritation (qualifier value)'}, {'cui': 'C0009253', 'cui_str': 'Sexual Intercourse'}]","[{'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1700235', 'cui_str': '(11BAPOP2) estradiol'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0036594', 'cui_str': 'Self Concept'}, {'cui': 'C0005891', 'cui_str': 'Body Image'}, {'cui': 'C0222045'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0429263', 'cui_str': 'Vaginal pH (observable entity)'}, {'cui': 'C0010820', 'cui_str': 'cytology'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0278098', 'cui_str': 'Female sexual function (observable entity)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C1879301', 'cui_str': 'Patient Health Questionnaire'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",301.0,0.0763158,Depression symptoms were associated with worse DIVA scores for activities of daily living and emotional well-being (0.2- to 0.4-point higher DIVA score for each 5- point worsening of PHQ-8 score).,"[{'ForeName': 'Mary M', 'Initials': 'MM', 'LastName': 'Hunter', 'Affiliation': 'School of Nursing, University of California San Francisco, San Francisco, CA. Electronic address: mary.hunter@ucsf.edu.'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Guthrie', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Joseph C', 'Initials': 'JC', 'LastName': 'Larson', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Susan D', 'Initials': 'SD', 'LastName': 'Reed', 'Affiliation': 'Obstetrics and Gynecology, University of Washington, Seattle, WA.'}, {'ForeName': 'Caroline M', 'Initials': 'CM', 'LastName': 'Mitchell', 'Affiliation': 'Obstetrics and Gynecology, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Susan J', 'Initials': 'SJ', 'LastName': 'Diem', 'Affiliation': 'Department of Medicine, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Andrea Z', 'Initials': 'AZ', 'LastName': 'LaCroix', 'Affiliation': 'Family Medicine and Public Health, University of California San Diego, La Jolla, CA.'}, {'ForeName': 'Alison J', 'Initials': 'AJ', 'LastName': 'Huang', 'Affiliation': 'School of Medicine, University of California San Francisco, San Francisco, CA.'}]",The journal of sexual medicine,['10.1016/j.jsxm.2019.10.010']
1003,31488225,Portion size normality and additional within-meal food intake: two crossover laboratory experiments.,"Reducing food portion size could reduce energy intake. However, it is unclear at what point consumers respond to reductions by increasing intake of other foods. We predicted that a change in served portion size would only result in significant additional eating within the same meal if the resulting portion size was no longer visually perceived as 'normal'. Participants in two crossover experiments (Study 1: n 45; Study 2: n 37; adults, 51 % female) were served different-sized lunchtime portions on three occasions that were perceived by a previous sample of participants as 'large-normal', 'small-normal' and 'smaller than normal', respectively. Participants were able to serve themselves additional helpings of the same food (Study 1) or dessert items (Study 2). In Study 1 there was a small but significant increase in additional intake when participants were served the 'smaller than normal' compared with the 'small-normal' portion (m difference = 161 kJ, P = 0·002, d = 0·35), but there was no significant difference between the 'small-normal' and 'large-normal' conditions (m difference = 88 kJ, P = 0·08, d = 0·24). A similar pattern was observed in Study 2 (m difference = 149 kJ, P = 0·06, d = 0·18; m difference = 83 kJ, P = 0·26, d = 0·10). However, smaller portion sizes were each associated with a significant reduction in total meal intake. The findings provide preliminary evidence that reductions that result in portions appearing 'normal' in size may limit additional eating, but confirmatory research is needed.",2020,"In Study 1 there was a small but significant increase in additional intake when participants were served the 'smaller than normal' compared to the 'small-normal' portion, m difference = 39 kcal, p = .002","['Participants in two crossover experiments (Study 1: N = 45; Study 2: N = 37; adults, 51% female']",[],"['total meal intake', 'energy intake', 'additional intake', ""small-normal' and 'large-normal' conditions""]","[{'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086287', 'cui_str': 'Females'}]",[],"[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]",,0.108882,"In Study 1 there was a small but significant increase in additional intake when participants were served the 'smaller than normal' compared to the 'small-normal' portion, m difference = 39 kcal, p = .002","[{'ForeName': 'Ashleigh', 'Initials': 'A', 'LastName': 'Haynes', 'Affiliation': 'Centre for Behavioural Research in Cancer, Cancer Council Victoria, Melbourne, VIC 3004, Australia.'}, {'ForeName': 'Charlotte A', 'Initials': 'CA', 'LastName': 'Hardman', 'Affiliation': 'Department of Psychological Sciences, University of Liverpool, Liverpool L69 7ZA, UK.'}, {'ForeName': 'Jason C G', 'Initials': 'JCG', 'LastName': 'Halford', 'Affiliation': 'Department of Psychological Sciences, University of Liverpool, Liverpool L69 7ZA, UK.'}, {'ForeName': 'Susan A', 'Initials': 'SA', 'LastName': 'Jebb', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford OX2 6GG, UK.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Robinson', 'Affiliation': 'Department of Psychological Sciences, University of Liverpool, Liverpool L69 7ZA, UK.'}]",The British journal of nutrition,['10.1017/S0007114519002307']
1004,31436925,Effectiveness of fluoride varnish four times a year in preventing caries in the primary dentition: A 2 year randomized controlled trial.,"OBJECTIVES


To test the effectiveness of fluoride varnish in preventing caries in early childhood in children at high risk of caries.
BASIC RESEARCH DESIGN


Randomized controlled trial.
PARTICIPANTS


504 participants, with mean age of 21 months at baseline randomly allocated into a test and a control group. 427 children remained in the study after two years.
INTERVENTION


Fluoride varnish applied four times a year, every three months. The intervention lasted for two years.
MAIN OUTCOME MEASURES


Dental status was recorded based on the International Caries Detection and Assessment System (ICADS).
RESULTS


Mean dmfs was similar in the control and test groups at baseline (1.0 and 1.2 respectively) but was significantly different (10.1 and 5.2, p ⟨ 0.001, ANOVA) at endpoint. The proportion caries free in the two groups was 40% and 69.4% after two years.
CONCLUSIONS


The application of fluoride varnish four times a year prevented the incidence and reduced the severity of caries in pre-school children.
TRIAL REGISTRATION NUMBER


DRKS00013980.",2019,"Mean dmfs was similar in the control and test groups at baseline (1.0 and 1.2 respectively) but was significantly different (10.1 and 5.2, p ⟨ 0.001, ANOVA) at endpoint.","['427 children remained in the study after two years', 'caries in the primary dentition', 'pre-school children', '504 participants, with mean age of 21 months at baseline randomly allocated into a test and a control group', 'children at high risk of caries']","['Fluoride varnish', 'fluoride varnish']","['severity of caries', 'proportion caries free', 'International Caries Detection and Assessment System (ICADS', 'Mean dmfs']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0333519', 'cui_str': 'Caries (morphologic abnormality)'}, {'cui': 'C3266841', 'cui_str': 'Baby Teeth'}, {'cui': 'C0424930', 'cui_str': 'Pre-school (environment)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0016326', 'cui_str': 'Fluoride Varnishes'}]","[{'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0333519', 'cui_str': 'Caries (morphologic abnormality)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0669180', 'cui_str': 'ICAD (inhibitor)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",504.0,0.0685081,"Mean dmfs was similar in the control and test groups at baseline (1.0 and 1.2 respectively) but was significantly different (10.1 and 5.2, p ⟨ 0.001, ANOVA) at endpoint.","[{'ForeName': 'B', 'Initials': 'B', 'LastName': 'Latifi-Xhemajli', 'Affiliation': 'Department of Pediatric and Preventive Dentistry, Faculty of Medicine, University of Pristina, Pristina, Kosovo.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Begzati', 'Affiliation': 'Department of Pediatric and Preventive Dentistry, Faculty of Medicine, University of Pristina, Pristina, Kosovo.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Veronneau', 'Affiliation': 'McGill University, Faculty of Dentistry, Montreal, Canada.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Kutllovci', 'Affiliation': 'Department of Pediatric and Preventive Dentistry, Faculty of Medicine, University of Pristina, Pristina, Kosovo.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Rexhepi', 'Affiliation': 'Department of Pediatric and Preventive Dentistry, Faculty of Medicine, University of Pristina, Pristina, Kosovo.'}]",Community dental health,['10.1922/CDH_4453Begzati05']
1005,31449880,"Design and participant characteristics of TX sprouts: A school-based cluster randomized gardening, nutrition, and cooking intervention.","AIMS


To outline the study design, outcome measures, protocol and baseline characteristics of enrolled participants of Texas (TX) Sprouts, a one-year school-based gardening, nutrition, and cooking cluster randomized trial.
METHODS


Eight schools were randomly assigned to the TX Sprouts intervention and eight schools to the delayed intervention over three years (2016-2019). The intervention arm received: formation/training of Garden Leadership Committees; a 0.25-acre outdoor teaching garden; 18 student lessons including gardening, nutrition, and cooking activities, taught weekly during school hours by hired educators throughout one school year; and nine parent lessons taught monthly to families. The delayed intervention was implemented the following academic year and received the same protocol as the intervention arm. Primary outcomes included: dietary intake, dietary-related behaviors, obesity, and metabolic parameters. Child measures included: height, weight, waist circumference, body composition, blood pressure, and dietary psychosocial variables. A subsample of children were measured for glucose, hemoglobin-A1C, and 24-hour dietary recalls. Parent measures included: height and weight, dietary intake, and related dietary psychosocial variables.
RESULTS


Of the 4239 eligible students, 3137 students consented and provided baseline clinical measures; 3132 students completed child surveys, with 92% of their parents completing parent surveys. The subsamples of blood draws and dietary recalls were 34% and 24%, respectively. Intervention arm baseline descriptives, clinical and dietary data for children and parents are reported.
CONCLUSION


The TX Sprouts intervention targeted primarily low-income Hispanic children and their parents; utilized an interactive gardening, nutrition, and cooking program; and measured a battery of dietary behaviors, obesity and metabolic outcomes.",2019,"A subsample of children were measured for glucose, hemoglobin-A1C, and 24-hour dietary recalls.","['3137 students consented and provided baseline clinical measures; 3132 students completed child surveys, with 92% of their parents completing parent surveys', 'Eight schools', 'enrolled participants of Texas (TX) Sprouts, a one-year school-based gardening, nutrition, and cooking cluster randomized trial', '4239 eligible students']","['TX Sprouts intervention and eight schools to the delayed intervention', 'formation/training of Garden Leadership Committees; a 0.25-acre outdoor teaching garden; 18 student lessons including gardening, nutrition, and cooking activities, taught weekly during school hours by hired educators throughout one school year; and nine parent lessons taught monthly to families']","['height, weight, waist circumference, body composition, blood pressure, and dietary psychosocial variables', 'glucose, hemoglobin-A1C, and 24-hour dietary recalls', 'height and weight, dietary intake, and related dietary psychosocial variables', 'dietary intake, dietary-related behaviors, obesity, and metabolic parameters', 'blood draws and dietary recalls']","[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0039711', 'cui_str': 'Texas'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0868963', 'cui_str': 'Gardening'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C1306756', 'cui_str': 'Cook (occupation)'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C4019428', 'cui_str': 'Gardens'}, {'cui': 'C0023181', 'cui_str': 'Leadership'}, {'cui': 'C4517443', 'cui_str': '0.25 (qualifier value)'}, {'cui': 'C0560271', 'cui_str': 'acre (qualifier value)'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0868963', 'cui_str': 'Gardening'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0015576', 'cui_str': 'Family'}]","[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0424638', 'cui_str': 'Height and weight'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0190979', 'cui_str': 'Venesection'}]",,0.0246201,"A subsample of children were measured for glucose, hemoglobin-A1C, and 24-hour dietary recalls.","[{'ForeName': 'JaimieN', 'Initials': 'J', 'LastName': 'Davis', 'Affiliation': 'Department of Nutritional Sciences, University of Texas at Austin, Austin, TX, USA. Electronic address: Jaimie.davis@austin.utexas.edu.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Nikah', 'Affiliation': 'Department of Nutritional Sciences, University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Fiona M', 'Initials': 'FM', 'LastName': 'Asigbee', 'Affiliation': 'Department of Nutritional Sciences, University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Landry', 'Affiliation': 'Department of Nutritional Sciences, University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Sarvenaz', 'Initials': 'S', 'LastName': 'Vandyousefi', 'Affiliation': 'Department of Nutritional Sciences, University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Reem', 'Initials': 'R', 'LastName': 'Ghaddar', 'Affiliation': 'Department of Nutritional Sciences, University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Hoover', 'Affiliation': 'Department of Nutritional Sciences, University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Jeans', 'Affiliation': 'Department of Nutritional Sciences, University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Pont', 'Affiliation': 'Department of Pediatrics, Dell Medical School, University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Daphne', 'Initials': 'D', 'LastName': 'Richards', 'Affiliation': 'Texas A&M AgriLife Extension Service, Travis County, USA.'}, {'ForeName': 'Deanna M', 'Initials': 'DM', 'LastName': 'Hoelscher', 'Affiliation': 'Michael & Susan Dell Center for Healthy Living, Department of Health Promotion and Behavioral Sciences, UTHealth School of Public Health, Austin Campus, Austin, USA.'}, {'ForeName': 'Alexandra E', 'Initials': 'AE', 'LastName': 'Van Den Berg', 'Affiliation': 'Michael & Susan Dell Center for Healthy Living, Department of Health Promotion and Behavioral Sciences, UTHealth School of Public Health, Austin Campus, Austin, USA.'}, {'ForeName': 'Meagan', 'Initials': 'M', 'LastName': 'Bluestein', 'Affiliation': 'Michael & Susan Dell Center for Healthy Living, Department of Biostatistics and Data Science, University of Texas Health (UTHealth) Science Center, Austin Regional Campus, Austin, USA.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Pérez', 'Affiliation': 'Michael & Susan Dell Center for Healthy Living, Department of Biostatistics and Data Science, University of Texas Health (UTHealth) Science Center, Austin Regional Campus, Austin, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105834']
1006,31479075,"Evaluation of a Brief, Skill-Building, Supportive, and Educational Intervention for Couples After Brain Injury.","OBJECTIVE


To examine the effectiveness of an intervention (Therapeutic Couples Intervention, TCI) designed to improve relationship quality for couples after acquired brain injury.
SETTING


Outpatient brain injury rehabilitation center.
PARTICIPANTS


Persons with brain injury (n = 75) and their intimate partners (n = 75).
DESIGN


Two-arm parallel, randomized, controlled trial with wait-listed control.
METHODS


Composed of 5 to 6 2-hour sessions, the TCI is a manualized, treatment program designed to enhance relationship quality by addressing issues and concerns most often identified by persons with brain injury and their partners.
MAIN MEASURE


Revised Dyadic Adjustment Scale completed by the persons with brain injury and their partners.
RESULTS


Persons with brain injury and their partners in the treatment group showed an improvement in relationship quality, both compared with their own baseline values and the control group.
CONCLUSIONS


Investigation provided evidence that a curriculum-based education, skill-building, and supportive intervention can benefit couples for up to 3 months after treatment. Additional research is needed to ascertain the long-term benefits of intervention and the efficacy of alternative delivery methods (eg, Internet, telephone, and group).",2020,"RESULTS


Persons with brain injury and their partners in the treatment group showed an improvement in relationship quality, both compared with their own baseline values and the control group.
","['Persons with brain injury (n = 75) and their intimate partners (n = 75', 'Composed of 5 to 6 2-hour sessions', 'persons with brain injury and their partners', 'Outpatient brain injury rehabilitation center', 'Couples', 'couples after acquired brain injury']","['intervention (Therapeutic Couples Intervention, TCI', 'Skill-Building, Supportive, and Educational Intervention']",['relationship quality'],"[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0270611', 'cui_str': 'Brain Injuries'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C1292425', 'cui_str': '2 hours (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0034993', 'cui_str': 'Rehabilitation Centers'}, {'cui': 'C0010222', 'cui_str': 'Couples'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0010222', 'cui_str': 'Couples'}]","[{'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]",,0.03408,"RESULTS


Persons with brain injury and their partners in the treatment group showed an improvement in relationship quality, both compared with their own baseline values and the control group.
","[{'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Kreutzer', 'Affiliation': 'Departments of Physical Medicine and Rehabilitation (Drs Kreutzer, Graham, Hsu, Mills, and Lukow and Ms Marwitz) and Biostatistics (Dr Sima), Virginia Commonwealth University, Richmond.'}, {'ForeName': 'Jennifer H', 'Initials': 'JH', 'LastName': 'Marwitz', 'Affiliation': ''}, {'ForeName': 'Adam P', 'Initials': 'AP', 'LastName': 'Sima', 'Affiliation': ''}, {'ForeName': 'Kristin M', 'Initials': 'KM', 'LastName': 'Graham', 'Affiliation': ''}, {'ForeName': 'Nancy H', 'Initials': 'NH', 'LastName': 'Hsu', 'Affiliation': ''}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Mills', 'Affiliation': ''}, {'ForeName': 'Herman R', 'Initials': 'HR', 'LastName': 'Lukow', 'Affiliation': ''}]",The Journal of head trauma rehabilitation,['10.1097/HTR.0000000000000519']
1007,31479083,Effects of Computerized Cognitive Training and Tai Chi on Cognitive Performance in Older Adults With Traumatic Brain Injury.,"OBJECTIVE


To compare the effects of computerized cognitive training (CCT) and tai chi (TC) with usual care (UC) on cognitive functions and secondary outcomes in older adults with traumatic brain injury.
PARTICIPANTS AND SETTINGS


Ninety-six patients aged 55 years and older who had a diagnosis of traumatic brain injury requiring hospital admission.
DESIGN


Randomized controlled trial.
MAIN MEASURES


The Mattis Dementia Rating Scale (MDRS), Mini-Mental State Examination, modified Telephone Interview of Cognitive Status, and Trail Making Tests A and B.
RESULTS


Compared with UC, CCT increased scores on the MDRS's total, attention, and memory and those on the Mini-Mental State Examination and Telephone Interview of Cognitive Status over the 6-month intervention; TC increased scores on the MDRS's total and conceptualization and those on the Mini-Mental State Examination over the 6-month intervention, while it also increased scores on the MDRS's total and initiation/preservation and those on the Telephone Interview of Cognitive Status and reduced the time to complete the Trail Making Test B over the 12-month study. Furthermore, compared with UC, CCT increased handgrip strength and TC reduced the time to complete 5 sit-to-stands over the 6-month intervention.
CONCLUSION


Both CCT and TC may improve global cognition and different specific cognitive domains in older traumatic brain injury patients; the TC's effect may last for at least an additional 6 months.",2020,"Compared with UC, CCT increased scores on the MDRS's total, attention, and memory and those on the Mini-Mental State Examination and Telephone Interview of Cognitive Status over the 6-month intervention; TC increased scores on the MDRS's total and conceptualization and those on the Mini-Mental State Examination over the 6-month intervention, while it also increased scores on the MDRS's total and initiation/preservation and those on the Telephone Interview of Cognitive Status and reduced the time to complete the Trail Making Test B over the 12-month study.","['Older Adults With Traumatic Brain Injury', 'older traumatic brain injury patients', 'older adults with traumatic brain injury', 'Ninety-six patients aged 55 years and older who had a diagnosis of traumatic brain injury requiring hospital admission']","['UC, CCT', 'CCT and TC', 'Computerized Cognitive Training and Tai Chi', 'computerized cognitive training (CCT) and tai chi (TC) with usual care (UC']","[""MDRS's total, attention, and memory and those on the Mini-Mental State Examination and Telephone Interview of Cognitive Status"", 'Mattis Dementia Rating Scale (MDRS), Mini-Mental State Examination, modified Telephone Interview of Cognitive Status, and Trail Making', 'handgrip strength and TC', 'global cognition', 'Cognitive Performance']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0876926', 'cui_str': 'TBI (Traumatic Brain Injury)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission (procedure)'}]","[{'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0376403', 'cui_str': 'Taiji'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0451306', 'cui_str': 'Folstein Mini-Mental State Examination'}, {'cui': 'C0021823', 'cui_str': 'Interviews, Telephone'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0451074', 'cui_str': 'Dementia Rating Scale'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",96.0,0.0358781,"Compared with UC, CCT increased scores on the MDRS's total, attention, and memory and those on the Mini-Mental State Examination and Telephone Interview of Cognitive Status over the 6-month intervention; TC increased scores on the MDRS's total and conceptualization and those on the Mini-Mental State Examination over the 6-month intervention, while it also increased scores on the MDRS's total and initiation/preservation and those on the Telephone Interview of Cognitive Status and reduced the time to complete the Trail Making Test B over the 12-month study.","[{'ForeName': 'Hei-Fen', 'Initials': 'HF', 'LastName': 'Hwang', 'Affiliation': 'Department of Nursing, National Taipei University of Nursing and Health Sciences, Taipei, Taiwan (Dr Hwang); Institute of Injury Prevention and Control, College of Public Health, Taipei Medical University, Taipei, Taiwan (Drs Hwang and Lin and Ms Chen); Division of Neurosurgery, Department of Surgery, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, New Taipei City, Taiwan (Dr Wei); Department of Emergency Medicine, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan (Dr Chen); Department of Emergency Medicine, Taipei Medical University Hospital, Taipei, Taiwan (Dr Yu); and Master Program in Long-Term Care, College of Nursing, Taipei Medical University, Taipei, Taiwan (Dr Lin).'}, {'ForeName': 'Chih-Yi', 'Initials': 'CY', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wei', 'Affiliation': ''}, {'ForeName': 'Sy-Jou', 'Initials': 'SJ', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Wen-Yu', 'Initials': 'WY', 'LastName': 'Yu', 'Affiliation': ''}, {'ForeName': 'Mau-Roung', 'Initials': 'MR', 'LastName': 'Lin', 'Affiliation': ''}]",The Journal of head trauma rehabilitation,['10.1097/HTR.0000000000000533']
1008,31596518,Interleukin-18 in patients with acute coronary syndromes.,"BACKGROUND


We aimed to assess associations between circulating IL-18 concentrations and cardiovascular outcomes in patients with acute coronary syndromes (ACS).
HYPOTHESIS AND METHODS


Plasma IL-18 concentrations were measured at admission, discharge, 1 month, and 6 months in patients with ACS in the PLATelet inhibition and patient Outcomes (PLATO) trial. Associations with outcomes were evaluated with Cox regression models on the composite of CV death, spontaneous myocardial infarction (sMI), or stroke; and on CV death or sMI separately, including adjustment for clinical risk factors and biomarkers (cTnT-hs, NT-proBNP, cystatin C, CRP-hs, and GDF-15).
RESULTS


Median IL-18 concentrations at baseline, discharge, 1 month, and 6 months were 237, 283, 305, and 320 ng/L (n = 16 636). Male sex, obesity, diabetes, and plasma levels of cystatin C, GDF-15, and CRP-hs were independently associated with higher IL-18 levels. Higher baseline IL-18 levels were associated with the composite endpoint and with CV death (hazard ratio [HR] 1.05, 95% confidence interval [95% CI] 1.02-1.07 and HR 1.10, 95% CI 1.06-1.14, respectively, per 25% increase of IL-18 levels). Associations remained significant after adjustment for clinical variables but became non-significant after adjustment for all biomarkers (HR 1.01, 95% CI 0.98-1.04 and HR 1.04, 95% CI 1.00-1.08, respectively). There were no associations with sMI.
CONCLUSIONS


In ACS patients, IL-18 concentrations increased after the acute event and remained increased for 6 months. Baseline IL-18 levels were significantly associated with CV mortality, independent of clinical characteristics and indicators of renal/cardiac dysfunction but this association was attenuated after adjustment for multiple biomarkers.",2019,"Baseline IL-18 levels were significantly associated with CV mortality, independent of clinical characteristics and indicators of renal/cardiac dysfunction but this association was attenuated after adjustment for multiple biomarkers.","['patients with ACS in the PLATelet inhibition and patient Outcomes (PLATO) trial', 'patients with acute coronary syndromes', 'patients with acute coronary syndromes (ACS']",[],"['Plasma IL-18 concentrations', 'Baseline IL-18 levels', 'Median IL-18 concentrations', 'CV death', 'clinical characteristics and indicators of renal/cardiac dysfunction', 'IL-18 concentrations', 'Higher baseline IL-18 levels', 'IL-18 levels', 'composite of CV death, spontaneous myocardial infarction (sMI), or stroke; and on CV death or sMI separately, including adjustment for clinical risk factors and biomarkers (cTnT-hs, NT-proBNP, cystatin C, CRP-hs, and GDF-15']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],"[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0383327', 'cui_str': 'Interleukin 18'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C3277906', 'cui_str': 'Cardiac dysfunction'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C3538889', 'cui_str': 'Cardiac troponin T'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0071744', 'cui_str': 'Cystatin C'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0668195', 'cui_str': 'Macrophage Inhibitory Cytokine 1'}]",16636.0,0.434071,"Baseline IL-18 levels were significantly associated with CV mortality, independent of clinical characteristics and indicators of renal/cardiac dysfunction but this association was attenuated after adjustment for multiple biomarkers.","[{'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Åkerblom', 'Affiliation': 'Department of Medical Sciences, Cardiology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Stefan K', 'Initials': 'SK', 'LastName': 'James', 'Affiliation': 'Department of Medical Sciences, Cardiology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Tatevik G', 'Initials': 'TG', 'LastName': 'Lakic', 'Affiliation': 'Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Richard C', 'Initials': 'RC', 'LastName': 'Becker', 'Affiliation': 'Division of Cardiovascular Health and Disease, Heart, Lung, and Vascular Institute, University of Cincinnati College of Medicine, Cincinnati, Ohio.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Cannon', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Philippe G', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'Département Hospitalo-Universitaire FIRE, AP-, Paris, France.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Himmelmann', 'Affiliation': 'AstraZeneca Research and Development, Gothenburg, Sweden.'}, {'ForeName': 'Hugo A', 'Initials': 'HA', 'LastName': 'Katus', 'Affiliation': 'Medizinishe Klinik, Universitätsklinikum Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Storey', 'Affiliation': 'Department of Infection, Immunity and Cardiovascular Disease, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Wallentin', 'Affiliation': 'Department of Medical Sciences, Cardiology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'W Douglas', 'Initials': 'WD', 'LastName': 'Weaver', 'Affiliation': 'Henry Ford Heart and Vascular Institute, Detroit, Michigan.'}, {'ForeName': 'Agneta', 'Initials': 'A', 'LastName': 'Siegbahn', 'Affiliation': 'Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical cardiology,['10.1002/clc.23274']
1009,31809265,Adherence to multiple medications in the TODAY (Treatment Options for type 2 Diabetes in Adolescents and Youth) cohort: effect of additional medications on adherence to primary diabetes medication.,"Background Non-adherence to diabetes medication leads to poor outcomes and increased healthcare costs. Multiple factors affecting adherence in adults with type 2 diabetes (T2D) have been identified, but pediatric data is sparse. We aimed to determine whether initiation of additional oral medications or insulin affects adherence to primary study medication (PSM) in the Treatment Options for type 2 Diabetes in Adolescents and Youth (TODAY) study. Methods Six hundred and ninety-nine youth (aged 10-17 years) with recent-onset T2D were randomized in the TODAY study. Participants were categorized as adherent (≥80% taken by pill count) or non-adherent (<80%), and adherence was compared between those on additional medications or not. Subgroup analyses to assess influence of race/ethnicity, gender, medication type, or depression were performed. Results At 36 months, 46.3% of participants were taking additional oral medications and 31.9% were on insulin. There was no difference in study medication adherence with additional oral medications (55.1%, 67.1%, and 56.7% at month 36 in those prescribed 0, 1, or 2+  additional medications; p = 0.16). Girls on oral contraceptives (OC) had higher adherence (65.2% vs. 55.8% at month 36; p = 0.0054). Participants on insulin had lower adherence (39.7% vs. 59.3% at 36 months; p < 0.0001). There was decreased adherence in participants with baseline depression (p = 0.008). Conclusions Additional oral medications did not influence adherence to diabetes medications in TODAY. Addition of insulin led to reduced adherence. In subgroup analyses, OC use was associated with higher adherence in girls, while baseline depression was associated with lower adherence overall. Further studies examining potentially modifiable risk factors of adherence in pediatric T2D are needed.",2020,Participants on insulin had lower adherence (39.7% vs. 59.3% at 36 months; p < 0.0001).,"['adults with type 2 diabetes (T2D', 'Methods Six hundred and ninety-nine youth (aged 10-17 years) with recent-onset', 'type 2 Diabetes in Adolescents and Youth (TODAY) study']","['oral contraceptives (OC', 'insulin']","['healthcare costs', 'study medication adherence with additional oral medications', 'adherence']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C3828813', 'cui_str': 'Ninety-nine'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0029151', 'cui_str': 'Oral contraception (finding)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}]","[{'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]",699.0,0.0953591,Participants on insulin had lower adherence (39.7% vs. 59.3% at 36 months; p < 0.0001).,"[{'ForeName': 'Rachana', 'Initials': 'R', 'LastName': 'Shah', 'Affiliation': ""Division of Endocrinology and Diabetes, Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}, {'ForeName': 'Siripoom V', 'Initials': 'SV', 'LastName': 'McKay', 'Affiliation': 'Department of Pediatrics, Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'Lorraine E', 'Initials': 'LE', 'LastName': 'Levitt Katz', 'Affiliation': ""Division of Endocrinology and Diabetes, Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}, {'ForeName': 'Laure', 'Initials': 'L', 'LastName': 'El Ghormli', 'Affiliation': 'The George Washington University Biostatistics Center, 6110 Executive Boulevard, Suite 750, Rockville, MD 20852, USA, Office: +301-881-9260, Fax: +301-881-3767.'}, {'ForeName': 'Barbara J', 'Initials': 'BJ', 'LastName': 'Anderson', 'Affiliation': ""Division of Endocrinology and Diabetes, Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}, {'ForeName': 'Terri L', 'Initials': 'TL', 'LastName': 'Casey', 'Affiliation': 'University Hospitals Cleveland Medical Center, Cleveland, OH, USA.'}, {'ForeName': 'Laurie', 'Initials': 'L', 'LastName': 'Higgins', 'Affiliation': 'Pediatric, Adolescent and Young Adult Section, Joslin Diabetes Center, Boston, MA, USA.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Izquierdo', 'Affiliation': 'State University of New York Upstate Medical University, Syracuse, NY, USA.'}, {'ForeName': 'Aimee D', 'Initials': 'AD', 'LastName': 'Wauters', 'Affiliation': 'University of Texas Health Science Center, San Antonio, TX, USA.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Chang', 'Affiliation': ""Diabetes and Obesity Program, Children's Hospital Los Angeles, Los Angeles, CA, USA.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of pediatric endocrinology & metabolism : JPEM,['10.1515/jpem-2019-0315']
1010,31991511,"Efficacy of vibegron, a novel β3-adrenoreceptor agonist, on severe urgency urinary incontinence related to overactive bladder: post hoc analysis of a randomized, placebo-controlled, double-blind, comparative phase 3 study.","OBJECTIVE


To evaluate the efficacy of a novel and selective β3-adrenoreceptor agonist vibegron on urgency urinary incontinence (UUI) in patients with overactive bladder (OAB).
PATIENTS AND METHODS


A post hoc analysis was performed in patients with UUI (>0 episodes/day) who were assigned to receive vibegron or placebo in a vibegron phase 3 study. Patients were subclassified into mild/moderate (>0 to <3 UUI episodes/day) or severe UUI (≥3 UUI episodes/day) subgroup. Changes from baseline in number of UUI episodes/day, in number of urgency episodes/day, and in voided volume/micturition were compared between the groups. The percentage of patients who became UUI-free ('diary-dry' rate) and the response rate (percentage of patients with scores 1 [feeling much better] or 2 [feeling better] assessed by the Patient Global Impression scale [PGI]) were evaluated.
RESULTS


Changes in numbers of UUI episodes at week 12 in the vibegron 50 mg, vibegron 100 mg and placebo groups, respectively, were -1.35, -1.47 and -1.08 in all patients, -1.04, -1.13 and -0.89 in the mild/moderate UUI subgroup, and -2.95, -3.28 and -2.10 in the severe UUI subgroup. The changes were significant in the vibegron 50 and 100 mg groups vs placebo regardless of symptom severity. Change in number of urgency episodes/day was significant in the vibegron 100 mg group vs placebo in all patients and in both severity subgroups. In the vibegron 50 mg group, a significant change vs placebo was observed in all patients and in the mild/moderate UUI subgroup. Change in voided volume/micturition was significantly greater in the vibegron 50 and 100 mg groups vs placebo in all patients, as well as in the both severity subgroups. Diary-dry rates in the vibegron 50 and 100 mg groups were significantly greater vs placebo in all patients and in the mild/moderate UUI subgroup. In the severe UUI subgroup, however, a significant difference was observed only in the vibegron 50 mg group. Response rates assessed by the PGI were significantly higher in the vibegron groups vs placebo in all patients and in the both severity subgroups. Vibegron administration, OAB duration ≤37 months, mean number of micturitions/day at baseline <12.0 and mean number of UUI episodes/day at baseline <3.0 were identified as factors significantly associated with normalization of UUI.
CONCLUSIONS


Vibegron, a novel β3-adrenoreceptor agonist, significantly reduced the number of UUI episodes/day and significantly increased the voided volume/micturition in patients with OAB including those with severe UUI, with the response rate exceeding 50%. These results suggest that vibegron can be an effective therapeutic option for OAB patients with UUI.",2020,Change in voided volume/micturition was significantly greater in the vibegron 50 mg and 100 mg groups versus placebo in all patients as well as in the both severity subgroups.,"['Patients were subclassified into mild-moderate (>0 to <3 UUI episodes/d) or severe UUI (≥3 UUI episodes/d) subgroup', 'in the vibegron phase 3 study and had UUI episodes ', 'OAB patients', 'severe urgency urinary incontinence related to overactive bladder', 'OAB patients with UUI']","['novel and selective β3-adrenoreceptor agonist vibegron', 'vibegron, a novel β3-adrenoreceptor agonist', 'placebo', 'vibegron or placebo']","['number of UUI episodes', 'response rate', 'Response rates assessed by PGI', 'Diary-dry rate', 'numbers of UUI episodes', 'feeling much better] or 2 [feeling better] assessed by Patient Global Impression', 'urgency urinary incontinence (UUI', 'Change in voided volume/micturition', 'voided volume/micturition', 'number of UUI episodes/d, number of urgency episodes/d, and voided volume/micturition', 'Diary-dry rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C4279743', 'cui_str': 'vibegron'}, {'cui': 'C0439561', 'cui_str': 'Phase 3 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0042024', 'cui_str': 'Urinary Incontinence'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0878773', 'cui_str': 'Overactive Bladder'}]","[{'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C4279743', 'cui_str': 'vibegron'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0205222', 'cui_str': 'Dry (qualifier value)'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C3841449', 'cui_str': 'Much better (qualifier value)'}, {'cui': 'C0332272', 'cui_str': 'Better (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0042024', 'cui_str': 'Urinary Incontinence'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}]",,0.155688,Change in voided volume/micturition was significantly greater in the vibegron 50 mg and 100 mg groups versus placebo in all patients as well as in the both severity subgroups.,"[{'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Yoshida', 'Affiliation': 'Department of Urology, National Centre for Geriatrics and Gerontology, Obu, Japan.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Takeda', 'Affiliation': 'Department of Urology, University of Yamanashi, Graduate School of Medical Sciences, Kofu, Japan.'}, {'ForeName': 'Momokazu', 'Initials': 'M', 'LastName': 'Gotoh', 'Affiliation': 'Department of Urology, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Yokoyama', 'Affiliation': 'Department of Urology, Faculty of Medical Science, University of Fukui, Fukui, Japan.'}, {'ForeName': 'Hidehiro', 'Initials': 'H', 'LastName': 'Kakizaki', 'Affiliation': 'Department of Renal and Urological Surgery, Asahikawa Medical University, Asahikawa, Japan.'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Takahashi', 'Affiliation': 'Department of Urology, Nihon University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Naoya', 'Initials': 'N', 'LastName': 'Masumori', 'Affiliation': 'Department of Urology, Sapporo Medical University School of Medicine, Sapporo, Japan.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Nagai', 'Affiliation': 'Kyorin Pharmaceutical Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Kazuyoshi', 'Initials': 'K', 'LastName': 'Minemura', 'Affiliation': 'Kyorin Pharmaceutical Co., Ltd., Tokyo, Japan.'}]",BJU international,['10.1111/bju.15020']
1011,31472039,Circulating dipeptidyl peptidase 3 and alteration in haemodynamics in cardiogenic shock: results from the OptimaCC trial.,"AIMS


Dipeptidyl peptidase 3 (DPP3) is a protease involved in the degradation of cardiovascular mediators. Its administration has been shown to be associated with impaired cardiac contraction and kidney haemodynamics while its inhibition restored cardiac contraction in a pre-clinical model of severe heart failure in mice. Circulating DPP3 (cDPP3) was found to be elevated in shock. The present study aims to assess the association between cDPP3 and worsening haemodynamics, namely refractory shock, in a cohort of cardiogenic shock (CS).
METHODS AND RESULTS


This is an ancillary study of OptimaCC, a prospective, double-blind, multicentre, randomized study assessing efficacy and safety of catecholamines in 57 patients with CS after acute myocardial infarction. cDPP3 was measured in plasma at inclusion, 24 h, 48 h, and 72 h, and haemodynamic and biological parameters were recorded at inclusion. cDPP3 values were higher in refractory CS than non-refractory CS at inclusion (median [interquartile range]; 76.1 [37.9-238.7] ng/mL vs. 32.8 [23.9-47.6] ng/mL, P = 0.014), at 24 h (P < 0.001) and up to 48 h (P = 0.027). Furthermore, cDPP3 at inclusion discriminated CS patients who did develop refractory shock vs. non-refractory with an area under the curve of 0.73 (95% confidence interval [CI] 0.55-0.92). The high cDPP3 group (cDPP3 ≥59.1 ng/mL) at inclusion had a higher Simplified Acute Physiology Score II (SAPS II), lower cardiac index and lower estimated glomerular filtration rate. More importantly, in CS patients with high cDPP3 at inclusion, those who rapidly decreased cDPP3 at 24 h exhibited a striking reduction in the occurrence of refractory shock and death.
CONCLUSION


In CS patients, cDPP3 gives an early prediction of outcome, including development of refractory status and/or survival.
CLINICAL TRIAL REGISTRATION


clinicaltrials.gov Identifier NCT01367743.",2020,"In CS patients, cDPP3 gives an early prediction of outcome, including development of refractory status and/or survival.
","['cardiogenic shock', '57 patients with CS after acute myocardial infarction']","['catecholamines', 'OptimaCC']","['haemodynamic and biological parameters', 'cDPP3', 'development of refractory status and/or survival', 'Simplified Acute Physiology Score II (SAPS II), lower cardiac index and lower estimated glomerular filtration rate', 'Circulating DPP3 (cDPP3', 'cDPP3 values']","[{'cui': 'C0036980', 'cui_str': 'Shock, Cardiogenic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction (disorder)'}]","[{'cui': 'C0007412', 'cui_str': 'Sympathins'}]","[{'cui': 'C4553887', 'cui_str': 'Biologic Drugs'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0428776', 'cui_str': 'Cardiac index (observable entity)'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C3811844'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.54922,"In CS patients, cDPP3 gives an early prediction of outcome, including development of refractory status and/or survival.
","[{'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Takagi', 'Affiliation': 'Inserm UMR-S 942, Cardiovascular Markers in Stress Conditions (MASCOT), University of Paris, Paris, France.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Blet', 'Affiliation': 'Inserm UMR-S 942, Cardiovascular Markers in Stress Conditions (MASCOT), University of Paris, Paris, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Levy', 'Affiliation': 'Intensive Care Medicine Brabois, CHRU de Nancy, INSERM U1116, 54511, Vandoeuvre-les-Nancy, Université de Lorraine, Nancy, France.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Deniau', 'Affiliation': 'Inserm UMR-S 942, Cardiovascular Markers in Stress Conditions (MASCOT), University of Paris, Paris, France.'}, {'ForeName': 'Feriel', 'Initials': 'F', 'LastName': 'Azibani', 'Affiliation': 'Inserm UMR-S 942, Cardiovascular Markers in Stress Conditions (MASCOT), University of Paris, Paris, France.'}, {'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'Feliot', 'Affiliation': 'Inserm UMR-S 942, Cardiovascular Markers in Stress Conditions (MASCOT), University of Paris, Paris, France.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Bergmann', 'Affiliation': '4TEEN4 Pharmaceuticals GmbH, Hennigsdorf, Germany.'}, {'ForeName': 'Karine', 'Initials': 'K', 'LastName': 'Santos', 'Affiliation': '4TEEN4 Pharmaceuticals GmbH, Hennigsdorf, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Hartmann', 'Affiliation': '4TEEN4 Pharmaceuticals GmbH, Hennigsdorf, Germany.'}, {'ForeName': 'Etienne', 'Initials': 'E', 'LastName': 'Gayat', 'Affiliation': 'Inserm UMR-S 942, Cardiovascular Markers in Stress Conditions (MASCOT), University of Paris, Paris, France.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Mebazaa', 'Affiliation': 'Inserm UMR-S 942, Cardiovascular Markers in Stress Conditions (MASCOT), University of Paris, Paris, France.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Kimmoun', 'Affiliation': 'Inserm UMR-S 942, Cardiovascular Markers in Stress Conditions (MASCOT), University of Paris, Paris, France.'}]",European journal of heart failure,['10.1002/ejhf.1600']
1012,31473331,A randomized controlled trial of a smoking cessation self-help intervention for Spanish-speaking Hispanic/Latinx smokers: Study design and baseline characteristics.,"Although the current smoking prevalence among Hispanics/Latinxs (10%) is lower than in non-Hispanic whites (15%), higher prevalence is observed among certain subgroups (e.g., Puerto Rican males, 19%). Hispanic/Latinx smokers face unique challenges such as lower awareness and acceptability of nicotine replacement aids, lower prevalence of using counseling or medication, and receiving less advice to quit by their health care providers. Despite these barriers to smoking cessation, few interventions specifically targeted to Hispanic/Latinx smokers have been developed and evaluated. This paper summarizes the design, methods, analysis plan, and sample baseline characteristics of an ongoing randomized controlled trial to assess the efficacy of a Spanish-language self-help smoking cessation intervention among Hispanics/Latinxs. Current smokers who prefer health education materials in Spanish were randomized to one of two conditions. The usual care group received a standard smoking cessation booklet developed by the National Cancer Institute. The intervention group received 10 booklets, 9 pamphlets and a booklet for family and friends mailed monthly over 18 months. All participants complete self-report surveys every 6 months over 2 years. Smoking abstinence is biochemically verified at 12- and 24-month follow-up. A total of 2387 smokers were screened, 2056 were eligible and 1417 were enrolled in the study. The primary outcome is self-reported 7-day point prevalence abstinence. If the intervention is deemed efficacious, it has potential to have a large public health impact with respect to reducing smoking rates and smoking related morbidity and mortality among a large underserved minority population.",2019,"If the intervention is deemed efficacious, it has potential to have a large public health impact with respect to reducing smoking rates and smoking related morbidity and mortality among a large underserved minority population.","['A total of 2387 smokers were screened, 2056 were eligible and 1417 were enrolled in the study', 'Hispanic/Latinx smokers', 'Current smokers who prefer health education materials in Spanish', 'Spanish-speaking Hispanic/Latinx smokers', 'Hispanics/Latinxs']","['smoking cessation self-help intervention', 'Spanish-language self-help smoking cessation intervention', 'standard smoking cessation booklet', '10 booklets, 9 pamphlets and a booklet for family and friends mailed monthly over 18\u202fmonths']","['self-reported 7-day point prevalence abstinence', 'Smoking abstinence']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C3241966'}, {'cui': 'C3543840', 'cui_str': 'Preferred'}, {'cui': 'C0018701'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C3161473', 'cui_str': 'Spaniards (ethnic group)'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}]","[{'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0037750', 'cui_str': 'Spanish language (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0079382', 'cui_str': 'Friend (person)'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}]",2056.0,0.0207541,"If the intervention is deemed efficacious, it has potential to have a large public health impact with respect to reducing smoking rates and smoking related morbidity and mortality among a large underserved minority population.","[{'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Medina-Ramírez', 'Affiliation': 'H. Lee Moffitt Cancer Center, Tampa, FL, USA.'}, {'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Sutton', 'Affiliation': 'H. Lee Moffitt Cancer Center, Tampa, FL, USA; University of South Florida, USA.'}, {'ForeName': 'Úrsula', 'Initials': 'Ú', 'LastName': 'Martínez', 'Affiliation': 'H. Lee Moffitt Cancer Center, Tampa, FL, USA.'}, {'ForeName': 'Cathy D', 'Initials': 'CD', 'LastName': 'Meade', 'Affiliation': 'H. Lee Moffitt Cancer Center, Tampa, FL, USA; University of South Florida, USA.'}, {'ForeName': 'Margaret M', 'Initials': 'MM', 'LastName': 'Byrne', 'Affiliation': 'H. Lee Moffitt Cancer Center, Tampa, FL, USA; University of South Florida, USA.'}, {'ForeName': 'Karen O', 'Initials': 'KO', 'LastName': 'Brandon', 'Affiliation': 'H. Lee Moffitt Cancer Center, Tampa, FL, USA.'}, {'ForeName': 'Lauren R', 'Initials': 'LR', 'LastName': 'Meltzer', 'Affiliation': 'H. Lee Moffitt Cancer Center, Tampa, FL, USA.'}, {'ForeName': 'Fiorella M', 'Initials': 'FM', 'LastName': 'Gonzales', 'Affiliation': 'H. Lee Moffitt Cancer Center, Tampa, FL, USA.'}, {'ForeName': 'Thomas H', 'Initials': 'TH', 'LastName': 'Brandon', 'Affiliation': 'H. Lee Moffitt Cancer Center, Tampa, FL, USA; University of South Florida, USA.'}, {'ForeName': 'Vani N', 'Initials': 'VN', 'LastName': 'Simmons', 'Affiliation': 'H. Lee Moffitt Cancer Center, Tampa, FL, USA; University of South Florida, USA. Electronic address: Vani.Simmons@Moffitt.org.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105836']
1013,31351135,Optimizing Outcomes of Single-Operator Cholangioscopy-Guided Biopsies Based on a Randomized Trial.,"BACKGROUND & AIMS


Although single-operator cholangioscopy is considered to be the most sensitive method for tissue acquisition in patients with indeterminate bile duct strictures (IBDS), methods are needed to optimize the specimen collection and processing techniques. We aimed to determine the optimal method for specimen processing and identify the number of biopsies required to establish a definitive diagnosis.
METHODS


Patients with IBDS were randomly assigned to groups that underwent specimen processing using the onsite (n = 32) or offsite (n = 30) method. The primary outcome was to compare operating characteristics of onsite vs offsite specimen processing techniques. The secondary outcome was number of biopsies needed to establish definitive diagnosis. A final diagnosis was established at surgery or after a minimum clinical follow-up period of 18 months RESULTS: The final diagnosis was benign disease in 33 patients and malignancy in 29 patients. There were no significant differences between the offsite and onsite groups in diagnostic accuracy (90% vs 87.5%; P=.99), sensitivity (76.9% vs 75%; P=.99), specificity (100% vs 100%; P=.99), positive predictive value (100% vs 100%; P=.99), or negative predictive value (85% vs 80%; P=.99). Although diagnoses were established by analysis of a median of 1 biopsy in the onsite cohort (interquartile range, 1-1.5), the diagnostic accuracy was identical (90%) in each group, regardless of whether 3 or 4 biopsies were collected from each patient in the offsite cohort.
CONCLUSIONS


In a prospective comparative study, we found that centers without onsite cytopathology support that analyze 3 single-operator cholangioscopy-guided biopsies of a biliary stricture and process the specimens offsite make the correct diagnosis for 90% of cases. ClinicalTrials.gov, Number: NCT01815619.",2020,"There were no significant differences between the offsite and onsite groups in diagnostic accuracy (90% vs 87.5%; P=.99), sensitivity (76.9% vs 75%; P=.99), specificity (100% vs 100%; P=.99),","['33 patients and malignancy in 29 patients', 'Patients with IBDS', 'patients with indeterminate bile duct strictures (IBDS']",['Single-Operator Cholangioscopy-Guided Biopsies'],"['positive predictive value', 'operating characteristics of onsite vs offsite specimen processing techniques', 'sensitivity', 'specificity', 'number of biopsies needed to establish definitive diagnosis', 'diagnostic accuracy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205258', 'cui_str': 'Indeterminate (qualifier value)'}, {'cui': 'C0235982', 'cui_str': 'Stricture of bile duct (disorder)'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0940834', 'cui_str': 'Cholangioscopy (procedure)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}]","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0449807', 'cui_str': 'Number of biopsies (qualifier value)'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0443196', 'cui_str': 'Definitive (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}]",,0.149809,"There were no significant differences between the offsite and onsite groups in diagnostic accuracy (90% vs 87.5%; P=.99), sensitivity (76.9% vs 75%; P=.99), specificity (100% vs 100%; P=.99),","[{'ForeName': 'Ji Young', 'Initials': 'JY', 'LastName': 'Bang', 'Affiliation': 'Center for Interventional Endoscopy, AdventHealth Orlando, Orlando, Florida.'}, {'ForeName': 'Udayakumar', 'Initials': 'U', 'LastName': 'Navaneethan', 'Affiliation': 'Center for Interventional Endoscopy, AdventHealth Orlando, Orlando, Florida.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Hasan', 'Affiliation': 'Center for Interventional Endoscopy, AdventHealth Orlando, Orlando, Florida.'}, {'ForeName': 'Bryce', 'Initials': 'B', 'LastName': 'Sutton', 'Affiliation': 'Center for Interventional Endoscopy, AdventHealth Orlando, Orlando, Florida.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Hawes', 'Affiliation': 'Center for Interventional Endoscopy, AdventHealth Orlando, Orlando, Florida.'}, {'ForeName': 'Shyam', 'Initials': 'S', 'LastName': 'Varadarajulu', 'Affiliation': 'Center for Interventional Endoscopy, AdventHealth Orlando, Orlando, Florida. Electronic address: svaradarajulu@yahoo.com.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2019.07.035']
1014,31470443,A Cadaveric Evaluation of Pin and Tension Band Configuration Strength for Tibial Tuberosity Osteotomy Fixation.,"OBJECTIVE


The purpose of this study was to compare the load at failure and mode of failure of four constructs used to stabilize a tibial tuberosity osteotomy, including two vertically aligned pins (V), two horizontally aligned pins (H), two vertically aligned pins with a tension band wire (V-TB) and two horizontally aligned pins with a tension band wire (H-TB).
STUDY DESIGN


Eighteen pairs of cadaveric tibiae were randomized to receive a TB or no TB. One limb was randomized to be in the H or V group. The contralateral limb was then assigned to the opposite configuration. One pair of limbs was used as a control. A tensile force was applied to the patellar ligament until construct failure.
RESULTS


There was no significant difference between the mean load at failure of the H (595 N) and V (556 N) groups or between H-TB (1032 N) and V-TB groups (1034 N) ( p  = 0.487 and  p  = 0.238, respectively). The TB constructs were significantly stronger than the pin only constructs ( p  < 0.001). The mode of failure was similar for the pin only constructs, regardless of pin orientation. The TB constructs and control tibias failed at similar loads, most commonly by patellar ligament rupture.
CONCLUSION


The use of vertically aligned pins versus horizontally aligned pins does not affect construct strength. These results support the placement of pins in a vertically or horizontally aligned fashion. When performing a tibial tuberosity osteotomy, the addition of a TB adds significant strength to the construct.",2020,"There was no significant difference between the mean load at failure of the H (595 N) and V (556 N) groups or between H-TB (1032 N) and V-TB groups (1034 N) ( p  = 0.487 and  p  = 0.238, respectively).","['Tibial Tuberosity Osteotomy Fixation', 'Eighteen pairs of cadaveric tibiae']","['tibial tuberosity osteotomy, including two vertically aligned pins (V), two horizontally aligned pins (H), two vertically aligned pins with a tension band wire (V-TB) and two horizontally aligned pins with a tension band wire (H-TB', 'vertically aligned pins versus horizontally aligned pins', 'TB or no TB']",[],"[{'cui': 'C0223896', 'cui_str': 'Structure of tibial tuberosity'}, {'cui': 'C0029468', 'cui_str': 'Osteotomy'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C3715206', 'cui_str': 'Eighteen'}]","[{'cui': 'C0223896', 'cui_str': 'Structure of tibial tuberosity'}, {'cui': 'C0029468', 'cui_str': 'Osteotomy'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2369992', 'cui_str': 'Align'}, {'cui': 'C0175718', 'cui_str': 'Bone Pins'}, {'cui': 'C0233494', 'cui_str': 'Tension (finding)'}, {'cui': 'C0185014', 'cui_str': 'Banding'}, {'cui': 'C0005978', 'cui_str': 'Bone Wires'}]",[],18.0,0.0481305,"There was no significant difference between the mean load at failure of the H (595 N) and V (556 N) groups or between H-TB (1032 N) and V-TB groups (1034 N) ( p  = 0.487 and  p  = 0.238, respectively).","[{'ForeName': 'Amy N', 'Initials': 'AN', 'LastName': 'Zide', 'Affiliation': 'Department of Veterinary Clinical Sciences, College of Veterinary Medicine, The Ohio State University, Columbus, Ohio, United States.'}, {'ForeName': 'Stephen C', 'Initials': 'SC', 'LastName': 'Jones', 'Affiliation': 'Department of Veterinary Clinical Sciences, College of Veterinary Medicine, The Ohio State University, Columbus, Ohio, United States.'}, {'ForeName': 'Alan S', 'Initials': 'AS', 'LastName': 'Litsky', 'Affiliation': 'Department of Biomedical Engineering, College of Engineering, The Ohio State University, Columbus, Ohio, United States.'}, {'ForeName': 'Nina R', 'Initials': 'NR', 'LastName': 'Kieves', 'Affiliation': 'Department of Veterinary Clinical Sciences, College of Veterinary Medicine, The Ohio State University, Columbus, Ohio, United States.'}]",Veterinary and comparative orthopaedics and traumatology : V.C.O.T,['10.1055/s-0039-1693968']
1015,31483377,Impact of early antiretroviral treatment on sexual behaviour in the INSIGHT Strategic Timing of Anti-Retroviral Treatment (START) Trial.,"BACKGROUND


Antiretroviral treatment (ART) reduces HIV infectiousness, but the effect of early ART on sexual behaviour is unclear.
METHODS


We assessed, within the START randomised trial that enrolled HIV-positive adults with CD4>500/mm, the effect of early (immediate) versus deferred ART on: (i) condomless sex with HIV-serodifferent partners (CLS-D); (ii) all condomless sex (CLS); (iii) HIV transmission-risk-sex (CLS-D-HIV-risk, defined as CLS-D and: not on ART or started ART < 6 months ago or viral load(VL)>200c/mL or no VL in past 6 months), during two year follow-up. Month-12 CLS-D (2010-2014) was the primary outcome.
RESULTS


Among 2562 MSM, there was no difference between immediate and deferred arms in CLS-D at month 12 [12.6% versus 13.1%; difference (95% CI): -0.4% (-3.1%, 2.2%), p = 0.75] or month 24, or in CLS. Among 2010 heterosexual men and women, CLS-D at month 12 tended to be higher in the immediate versus deferred arm [10.8% versus 8.3%; difference:2.5% (-0.1%, 5.2%), p = 0.062]; the difference was greater at month 24 [9.3% versus 5.6%; difference:3.7%(1.0%, 6.4%), p = 0.007], at which time CLS was higher in the immediate arm [20.7% versus 15.7%, p = 0.013]. CLS-D-HIV-risk at month 12 was substantially lower in the immediate versus deferred arm for MSM [0.2% versus 11.0%; difference: -10.7% (-12.5%, -8.9%), p < 0.001] and heterosexuals [0.6% versus 7.7%; difference: -7.0% (-8.8%, -5.3%), p < 0.001], due to viral suppression on ART.
CONCLUSIONS


A strategy of early ART had no effect on condomless sex with HIV-serodifferent partners among MSM, but resulted in modestly higher prevalence among heterosexuals. However, among MSM and heterosexuals, early ART resulted in a substantial reduction in HIV-transmission-risk-sex, to a very low absolute level.",2019,"CLS-D-HIV-risk at month 12 was substantially lower in the immediate versus deferred arm for MSM [0.2% versus 11.0%; difference: -10.7% (-12.5%, -8.9%), p < 0.001] and heterosexuals [0.6% versus 7.7%; difference: -7.0% (-8.8%, -5.3%), p < 0.001], due to viral suppression on ART.
","['2010 heterosexual men', 'enrolled HIV-positive adults with CD4>500/mm, the effect of early (immediate) versus']","['deferred ART on: (i) condomless sex with HIV-serodifferent partners (CLS-D); (ii) all condomless sex (CLS); (iii) HIV transmission-risk-sex (CLS-D-HIV-risk, defined as CLS-D and: not on ART or started ART\u200a<\u200a6 months ago or viral load(VL)>200c/mL or no VL']","['CLS-D-HIV-risk', 'sexual behaviour', 'time CLS']","[{'cui': 'C1527360', 'cui_str': 'Heterosexuals'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0019699', 'cui_str': 'HTLV-III Seroconversion'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}]","[{'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0036864', 'cui_str': 'Sexual Behavior'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",2562.0,0.322822,"CLS-D-HIV-risk at month 12 was substantially lower in the immediate versus deferred arm for MSM [0.2% versus 11.0%; difference: -10.7% (-12.5%, -8.9%), p < 0.001] and heterosexuals [0.6% versus 7.7%; difference: -7.0% (-8.8%, -5.3%), p < 0.001], due to viral suppression on ART.
","[{'ForeName': 'Fiona C', 'Initials': 'FC', 'LastName': 'Lampe', 'Affiliation': 'Institute for Global Health, University College London, London, United Kingdom.'}, {'ForeName': 'Alison J', 'Initials': 'AJ', 'LastName': 'Rodger', 'Affiliation': 'Institute for Global Health, University College London, London, United Kingdom.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Burman', 'Affiliation': 'Denver Public Health, University of Colorado Health Sciences Center, Denver CO, United States.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Grulich', 'Affiliation': 'The Kirby Institute, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'Friedland', 'Affiliation': 'Departments of Medicine and Epidemiology, Yale School of Medicine, New Haven CT United States.'}, {'ForeName': 'Wafaa El', 'Initials': 'WE', 'LastName': 'Sadr', 'Affiliation': 'Columbia University, New York, United States.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Neaton', 'Affiliation': 'University of Minnesota, Minnesota, United States.'}, {'ForeName': 'Giulio M', 'Initials': 'GM', 'LastName': 'Corbelli', 'Affiliation': 'European AIDS Treatment Group, Bruxelles, Belgium.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Emery', 'Affiliation': 'The Kirby Institute, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Jean Michel', 'Initials': 'JM', 'LastName': 'Molina', 'Affiliation': 'Université de Paris Diderot, Paris, France.'}, {'ForeName': 'Chloe', 'Initials': 'C', 'LastName': 'Orkin', 'Affiliation': 'Barts Health NHS Trust, London, United Kingdom.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Gatell', 'Affiliation': 'University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Gerstoft', 'Affiliation': 'Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Kiat', 'Initials': 'K', 'LastName': 'Ruxrungtham', 'Affiliation': 'Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Monica Barbosa de', 'Initials': 'MB', 'LastName': 'Souza', 'Affiliation': 'Universidade Federal do Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Phillips', 'Affiliation': 'Institute for Global Health, University College London, London, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","AIDS (London, England)",['10.1097/QAD.0000000000002359']
1016,32028783,Acupuncture for postprandial distress syndrome: a randomized controlled pilot trial.,"BACKGROUND


Evidence for treating postprandial distress syndrome with acupuncture is limited.
AIM


We aimed to evaluate the feasibility of verum acupuncture versus sham acupuncture in patients with postprandial distress syndrome.
METHODS


A total of 42 eligible patients were randomly allocated to either verum acupuncture or sham acupuncture groups in a 1:1 ratio. Each patient received 12 sessions over 4 weeks. The primary outcome was the response rate based on the overall treatment effect (OTE) 4 weeks after randomization. Secondary outcomes included dyspepsia symptom severity and adverse events.
RESULTS


In each group, 19 patients (91.5%) completed the study. Thirteen patients receiving verum acupuncture and seven patients receiving sham acupuncture were classified as responders according to OTE (61.9% vs 33.3%; rate difference 28.6%;  p  = 0.06). Dyspepsia symptom severity at the end of treatment also differed significantly between verum acupuncture and sham acupuncture groups (5.9 units vs 3.7 units; between-group difference 2.2 (95% CI, 0.2-4.2);  p  = 0.04). No serious adverse events occurred.
CONCLUSION


Four weeks of acupuncture may represent a potential treatment for postprandial distress syndrome. The treatment protocol and outcome measures used in this trial were feasible. Since this was a pilot study, the efficacy of acupuncture still needs to be determined by a larger, adequately powered trial.",2020,"No serious adverse events occurred.
","['A total of 42 eligible patients', 'patients with postprandial distress syndrome', 'Thirteen patients receiving', 'postprandial distress syndrome']","['verum acupuncture', 'verum acupuncture versus sham acupuncture', 'verum acupuncture and sham acupuncture', 'acupuncture', 'sham acupuncture', 'Acupuncture', 'verum acupuncture or sham acupuncture']","['dyspepsia symptom severity and adverse events', 'response rate based on the overall treatment effect (OTE', 'Dyspepsia symptom severity']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C3715149', 'cui_str': '13'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0013395', 'cui_str': 'Indigestion'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",42.0,0.514889,"No serious adverse events occurred.
","[{'ForeName': 'Jian-Feng', 'Initials': 'JF', 'LastName': 'Tu', 'Affiliation': 'Acupuncture Research Center, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Jing-Wen', 'Initials': 'JW', 'LastName': 'Yang', 'Affiliation': 'Acupuncture Research Center, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Li-Qiong', 'Initials': 'LQ', 'LastName': 'Wang', 'Affiliation': 'Acupuncture Research Center, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': 'Department of Acupuncture and Moxibustion, Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University, Beijing, China.'}, {'ForeName': 'Li-Wen', 'Initials': 'LW', 'LastName': 'Zhang', 'Affiliation': 'Department of Acupuncture and Moxibustion, Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University, Beijing, China.'}, {'ForeName': 'Yong-Ting', 'Initials': 'YT', 'LastName': 'Li', 'Affiliation': 'Acupuncture Research Center, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Acupuncture and Moxibustion, Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University, Beijing, China.'}, {'ForeName': 'Guang-Xia', 'Initials': 'GX', 'LastName': 'Shi', 'Affiliation': 'Acupuncture Research Center, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Acupuncture and Moxibustion, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Jing-Jie', 'Initials': 'JJ', 'LastName': 'Zhao', 'Affiliation': 'Department of Traditional Chinese Medicine, Beijing Friendship Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Du', 'Affiliation': 'Department of Traditional Chinese Medicine, Beijing Friendship Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'San-San', 'Initials': 'SS', 'LastName': 'Chen', 'Affiliation': 'Department of Acupuncture and Moxibustion, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Cheng', 'Affiliation': 'Department of Acupuncture and Moxibustion, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Cun-Zhi', 'Initials': 'CZ', 'LastName': 'Liu', 'Affiliation': 'Acupuncture Research Center, Beijing University of Chinese Medicine, Beijing, China.'}]",Acupuncture in medicine : journal of the British Medical Acupuncture Society,['10.1177/0964528419900911']
1017,31948507,Specific components of a complex depression care program can affect staff outcomes differently:  post-hoc  analyses of a stepped-wedge cluster-randomized trial in nursing homes.,"OBJECTIVE


The Act in case of Depression program showed effects on the quality of life and depression in nursing home (NH) residents. We aimed to explore the effects of this complex multidisciplinary program on job satisfaction, job demands, and autonomy in nursing home staff.
DESIGN


Four data points from a stepped-wedge cluster-randomized trial on patient outcomes were used for secondary analyses on staff outcomes.
SETTING


Sixteen dementia special care and 17 somatic care units in Dutch NHs.Participants were 717 (90.1%) care staff or trainees, 34 (4.3%) paramedical staff, and 45 (5.7%) other staff members.Intervention describes procedures for nursing staff, activity therapists, psychologists, and physicians. It contains evidence-based pathways for depression assessment, treatment, and monitoring treatment results.
RESULTS


Mixed models for intention-to-treat analyses showed no significant changes in job demands, job satisfaction, or autonomy. Models corrected for the ratio of unit residents who received, when indicated, a specific program component revealed reduced job demands and improved job satisfaction and autonomy when treatment procedures were used. A better use of assessment procedures was associated with increased job demands, while conducting monitoring procedures was associated with increased job demands and decreased autonomy.
CONCLUSIONS


Components of complex care programs may affect the staff outcomes in opposite directions and, taken together, produce a zero-sum or a statistically insignificant effect. While implementing treatment protocols affecting patients directly can also improve job outcomes such as satisfaction and autonomy and decrease job demands, it is possible that other procedures of complex programs may have unfavorable effects on job outcomes. It is important to account for specific components of complex interventions when evaluating intervention effects.",2020,"A better use of assessment procedures was associated with increased job demands, while conducting monitoring procedures was associated with increased job demands and decreased autonomy.
","['Participants were 717 (90.1%) care staff or trainees, 34 (4.3%) paramedical staff, and 45 (5.7%) other staff members', 'nursing home (NH) residents', 'nursing homes', 'Sixteen dementia special care and 17 somatic care units in Dutch NHs']","['complex depression care program', 'complex multidisciplinary program']","['job demands, job satisfaction, or autonomy', 'job satisfaction, job demands, and autonomy', 'job demands and improved job satisfaction and autonomy', 'quality of life and depression', 'job demands and decreased autonomy']","[{'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C4517759', 'cui_str': 'Four point three'}, {'cui': 'C4517795', 'cui_str': 'Five point seven'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0028688', 'cui_str': 'Nursing Homes'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0205555', 'cui_str': 'Special (qualifier value)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0013331', 'cui_str': 'Dutch (ethnic group)'}]","[{'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0028811', 'cui_str': 'Occupations'}, {'cui': 'C0022397', 'cui_str': 'Work Satisfaction'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}]",16.0,0.0297262,"A better use of assessment procedures was associated with increased job demands, while conducting monitoring procedures was associated with increased job demands and decreased autonomy.
","[{'ForeName': 'Ruslan', 'Initials': 'R', 'LastName': 'Leontjevas', 'Affiliation': 'Department of Primary and Community Care, Radboud University Medical Centre, Nijmegen, The Netherlands.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Hooijschuur', 'Affiliation': 'Stichting Humanitas, Rotterdam, The Netherlands.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Smalbrugge', 'Affiliation': 'Department of General Practice and Elderly Care Medicine, Amsterdam Public Health Research Institute, Amsterdam University Medical Centre, Amsterdam, The Netherlands.'}, {'ForeName': 'Raymond T C M', 'Initials': 'RTCM', 'LastName': 'Koopmans', 'Affiliation': 'Department of Primary and Community Care, Radboud University Medical Centre, Nijmegen, The Netherlands.'}, {'ForeName': 'Debby L', 'Initials': 'DL', 'LastName': 'Gerritsen', 'Affiliation': 'Department of Primary and Community Care, Radboud University Medical Centre, Nijmegen, The Netherlands.'}]",International psychogeriatrics,['10.1017/S1041610219002151']
1018,32006613,"An Individualized, Interactive, and Advance Care Planning Intervention Promotes Transitions in Prognostic Awareness States Among Terminally Ill Cancer Patients in Their Last Six Months-A Secondary Analysis of a Randomized Controlled Trial.","CONTEXT/OBJECTIVES


To examine whether an advance care planning intervention randomized controlled trial facilitates terminally ill cancer patients' transitions to accurate prognostic awareness (PA) and the time spent in the accurate PA state in patients' last six months.
METHODS


Participants (N = 460) were randomized 1:1 to experimental (interactive intervention tailored to participants' readiness for advance care planning/prognostic information) and control (symptom management education) arms with similar formats. PA was categorized into four states: 1) unknown and not wanting to know; 2) unknown but wanting to know; 3) inaccurate awareness; and 4) accurate awareness. Intervention effectiveness in the two outcomes was evaluated by intention-to-treat analysis with multistate Markov modeling (effect size ≥0.2 as minimal clinically important difference).
RESULTS


The final sample constituted 188 and 184 experimental arm and control arm participants who died and were repeatedly assessed, respectively. Experimental arm participants in States 1-3 had a higher probability of shifting to accurate PA (23.0%-35.4% vs. 15.2%-26.2%) than control arm participants, and all effect sizes met the minimal clinically important difference criterion (effect sizes 0.22-0.49). In their last six months, experimental arm participants spent more time in States 3 and 4 (0.18 vs. 0.08 and 2.94 vs. 2.38 months, respectively) but less time in States 1 and 2 (2.70 vs. 3.19 and 0.18 vs. 0.36 months, respectively) (effect sizes 0.11-0.19).
CONCLUSION


Our intervention meaningfully facilitated participants' transition toward accurate PA and more time spent in the accurate PA state (State 4). Our intervention can help health care professionals foster cancer patients' accurate PA earlier in the terminal illness trajectory to make informed end-of-life care decisions tailored to their readiness for prognostic information.",2020,Experimental-arm participants in states 1-3 had a higher probability of shifting to accurate PA (23.0-35.4% vs. 15.2-26.2%) than control-arm participants and all effect sizes met the MCID criterion (effect sizes=0.22-0.49).,"[""ill cancer patients' transitions"", 'Participants (N=460', 'terminally ill cancer patients']","[""experimental (interactive intervention tailored to participants' readiness for ACP/prognostic information) and control (symptom-management education) arms with similar formats"", 'advance-care planning (ACP) intervention', 'individualized, interactive, advance-care planning intervention']","['Intervention effectiveness', 'higher probability of shifting to accurate PA']","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0039552', 'cui_str': 'Terminally Ill'}]","[{'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1536570', 'cui_str': 'Symptom management (procedure)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1301627', 'cui_str': 'Format'}, {'cui': 'C0600371', 'cui_str': 'Advance Health Care Planning'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0333051', 'cui_str': 'Shift (morphologic abnormality)'}, {'cui': 'C0443131', 'cui_str': 'Accurate (qualifier value)'}]",460.0,0.0752918,Experimental-arm participants in states 1-3 had a higher probability of shifting to accurate PA (23.0-35.4% vs. 15.2-26.2%) than control-arm participants and all effect sizes met the MCID criterion (effect sizes=0.22-0.49).,"[{'ForeName': 'Chen Hsiu', 'Initials': 'CH', 'LastName': 'Chen', 'Affiliation': 'School of Nursing, National Taipei University of Nursing and Health Sciences, Taipei, Taiwan, Republic of China.'}, {'ForeName': 'Wen-Chi', 'Initials': 'WC', 'LastName': 'Chou', 'Affiliation': 'Division of Hematology-Oncology, Chang Gung Memorial Hospital at Linkou, Tao-Yuan, Taiwan, Republic of China; College of Medicine, Chang Gung University, Tao-Yuan, Taiwan, Republic of China.'}, {'ForeName': 'Jen-Shi', 'Initials': 'JS', 'LastName': 'Chen', 'Affiliation': 'Division of Hematology-Oncology, Chang Gung Memorial Hospital at Linkou, Tao-Yuan, Taiwan, Republic of China; College of Medicine, Chang Gung University, Tao-Yuan, Taiwan, Republic of China.'}, {'ForeName': 'Wen-Cheng', 'Initials': 'WC', 'LastName': 'Chang', 'Affiliation': 'Division of Hematology-Oncology, Chang Gung Memorial Hospital at Linkou, Tao-Yuan, Taiwan, Republic of China; College of Medicine, Chang Gung University, Tao-Yuan, Taiwan, Republic of China.'}, {'ForeName': 'Chia-Hsun', 'Initials': 'CH', 'LastName': 'Hsieh', 'Affiliation': 'Division of Hematology-Oncology, Chang Gung Memorial Hospital at Linkou, Tao-Yuan, Taiwan, Republic of China; College of Medicine, Chang Gung University, Tao-Yuan, Taiwan, Republic of China.'}, {'ForeName': 'Fur-Hsing', 'Initials': 'FH', 'LastName': 'Wen', 'Affiliation': 'Department of International Business, Soochow University, Taipei, Taiwan, Republic of China.'}, {'ForeName': 'Siew Tzuh', 'Initials': 'ST', 'LastName': 'Tang', 'Affiliation': 'Division of Hematology-Oncology, Chang Gung Memorial Hospital at Linkou, Tao-Yuan, Taiwan, Republic of China; College of Medicine, Chang Gung University, Tao-Yuan, Taiwan, Republic of China; School of Nursing, Medical College, Chang Gung University, Kwei-Shan, Tao-Yuan, Taiwan, Republic of China; Department of Nursing, Chang Gung Memorial Hospital at Kaohsiung, Kaohsiung, Taiwan, Republic of China. Electronic address: sttang@mail.cgu.edu.tw.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2020.01.012']
1019,31949295,Changes in weight control behaviors and hedonic hunger in a commercial weight management program adapted for individuals with type 2 diabetes.,"BACKGROUND


A WW (formerly Weight Watchers) program adapted for persons with type 2 diabetes mellitus (T2DM) previously was found to be more effective than standard care (SC) intervention for weight loss, improved glycemic control, and weight- and diabetes-related quality of life measures. With data from the same national trial, this study examined whether WW adapted for persons with T2DM also increased engagement in weight control behaviors and decreased hedonic hunger, each of which could contribute to improved diabetes management.
INTERVENTION AND METHODS


Individuals with T2DM (n = 563) and overweight or obesity participated in a 12-month, 16-site, randomized trial of WW with diabetes counseling or SC. Hierarchical linear modeling (HLM) evaluated whether 12-month changes in weight control behaviors (Eating Behavior Inventory; EBI) and hedonic hunger (Power of Food Scale; PFS) differed by treatment condition. If a significant treatment effect was found, 12-month changes in EBI/PFS were regressed on 12-month changes in HbA 1c  and percent weight loss to explore potential treatment differences in these associations.
RESULTS


EBI scores increased significantly over the 12-months (p < 0.001), with greater improvements in WW than SC (p < 0.001). PFS decreased significantly in the 12-months (p < 0.001), with no differences between treatment groups (p = 0.15). HLM analyses that followed up on the significant treatment effect for 12-month change in EBI revealed no significant differences by treatment condition for the relationship between change in EBI scores and change in HbA 1c  (p = 0.14) or percent weight loss (p = 0.32). Across all participants, 12-month improvements in EBI and PFS were related to improved HbA 1c  (r = 0.22; -0.13, respectively) and greater percent weight loss (r = 0.41; -0.18, respectively) (ps < 0.01).
CONCLUSIONS


WW with diabetes counseling produced greater engagement in weight control behaviors in those with T2DM than did SC. Across both groups, improved weight control behaviors and hedonic hunger were related to improved glycemic control and weight loss.",2020,"PFS decreased significantly in the 12-months (p < 0.001), with no differences between treatment groups (p = 0.15).","['Individuals with T2DM (n\u2009=\u2009563) and overweight or obesity participated', 'individuals with type 2 diabetes', 'persons with type 2 diabetes mellitus (T2DM']","['diabetes counseling or SC', 'standard care (SC) intervention']","['weight control behaviors and hedonic hunger', 'EBI scores', 'glycemic control and weight loss', 'weight control behaviors (Eating Behavior Inventory; EBI) and hedonic hunger (Power of Food Scale; PFS', 'percent weight loss', 'EBI and PFS', 'weight control behaviors', 'EBI/PFS', 'EBI scores and change in HbA 1c', 'PFS']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C1321111', 'cui_str': 'Weight control behavior'}, {'cui': 'C0020175', 'cui_str': 'Hunger'}, {'cui': 'C0059818', 'cui_str': 'isothiocyanic acid ethylene ester'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0222045'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}]",563.0,0.0155602,"PFS decreased significantly in the 12-months (p < 0.001), with no differences between treatment groups (p = 0.15).","[{'ForeName': 'Erica M', 'Initials': 'EM', 'LastName': 'Schulte', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Weight Management Center, Medical University of South Carolina, 67 President Street, Suite 410 South, Charleston, SC, 29425, USA. erica.schulte@pennmedicine.upenn.edu.'}, {'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'Tuerk', 'Affiliation': 'Department of Human Services, University of Virginia, Charlottesville, VA, USA.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Wadden', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'W Timothy', 'Initials': 'WT', 'LastName': 'Garvey', 'Affiliation': 'Department of Nutrition Sciences, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Weiss', 'Affiliation': 'Your Diabetes Endocrine Nutrition Group, Mentor, OH, USA.'}, {'ForeName': 'Kathie L', 'Initials': 'KL', 'LastName': 'Hermayer', 'Affiliation': 'Division of Endocrinology, Diabetes, & Medical Genetics, College of Medicine, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Louis J', 'Initials': 'LJ', 'LastName': 'Aronne', 'Affiliation': 'Division of Endocrinology, Diabetes, & Metabolism, Comprehensive Weight Center, Weill Cornell Medicine, New York, NY, USA.'}, {'ForeName': 'Lynne E', 'Initials': 'LE', 'LastName': 'Becker', 'Affiliation': 'TAIG, Inc, Reston, VA, USA.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Fujioka', 'Affiliation': 'Scripps Clinical Research, San Diego, CA, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Miller-Kovach', 'Affiliation': 'WW, New York, NY, USA.'}, {'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Kushner', 'Affiliation': 'Northwestern University, Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Malcolm', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Weight Management Center, Medical University of South Carolina, 67 President Street, Suite 410 South, Charleston, SC, 29425, USA.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Raum', 'Affiliation': 'Oregon Weight Loss Surgery, Portland, OR, USA.'}, {'ForeName': 'Stephanie L', 'Initials': 'SL', 'LastName': 'Rost', 'Affiliation': 'WW, New York, NY, USA.'}, {'ForeName': 'Domenica M', 'Initials': 'DM', 'LastName': 'Rubino', 'Affiliation': 'Washington Center for Weight Management & Research, Arlington, VA, USA.'}, {'ForeName': 'Nicoleta D', 'Initials': 'ND', 'LastName': 'Sora', 'Affiliation': 'Division of Endocrinology, Diabetes, & Medical Genetics, College of Medicine, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Jan L', 'Initials': 'JL', 'LastName': 'Veliko', 'Affiliation': 'WW, New York, NY, USA.'}, {'ForeName': 'Patrick M', 'Initials': 'PM', 'LastName': ""O'Neil"", 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Weight Management Center, Medical University of South Carolina, 67 President Street, Suite 410 South, Charleston, SC, 29425, USA. oneilp@musc.edu.'}]",International journal of obesity (2005),['10.1038/s41366-020-0530-x']
1020,31411950,Gefitinib Versus Gefitinib Plus Pemetrexed and Carboplatin Chemotherapy in  EGFR -Mutated Lung Cancer.,"PURPOSE


Standard first-line therapy for  EGFR -mutant advanced non-small-cell lung cancer (NSCLC) is an epidermal growth factor receptor (EGFR)-directed oral tyrosine kinase inhibitor. Adding pemetrexed and carboplatin chemotherapy to an oral tyrosine kinase inhibitor may improve outcomes.
PATIENTS AND METHODS


This was a phase III randomized trial in patients with advanced NSCLC harboring an  EGFR -sensitizing mutation and a performance status of 0 to 2 who were planned to receive first-line palliative therapy. Random assignment was 1:1 to gefitinib 250 mg orally per day (Gef) or gefitinib 250 mg orally per day plus pemetrexed 500 mg/m 2  and carboplatin area under curve 5 intravenously every 3 weeks for four cycles, followed by maintenance pemetrexed (gefitinib plus chemotherapy [Gef+C]). The primary end point was progression-free survival (PFS); secondary end points included overall survival (OS), response rate, and toxicity.
RESULTS


Between 2016 and 2018, 350 patients were randomly assigned to Gef (n = 176) and Gef+C (n = 174). Twenty-one percent of patients had a performance status of 2, and 18% of patients had brain metastases. Median follow-up time was 17 months (range, 7 to 30 months). Radiologic response rates were 75% and 63% in the Gef+C and Gef arms, respectively ( P  = .01). Estimated median PFS was significantly longer with Gef+C than Gef (16 months [95% CI, 13.5 to 18.5 months]  v  8 months [95% CI, 7.0 to 9.0 months], respectively; hazard ratio for disease progression or death, 0.51 [95% CI, 0.39 to 0.66];  P  < .001). Estimated median OS was significantly longer with Gef+C than Gef (not reached  v  17 months [95% CI, 13.5 to 20.5 months]; hazard ratio for death, 0.45 [95% CI, 0.31 to 0.65];  P  < .001). Clinically relevant grade 3 or greater toxicities occurred in 51% and 25% of patients in the Gef+C and Gef arms, respectively ( P  < .001).
CONCLUSION


Adding pemetrexed and carboplatin chemotherapy to gefitinib significantly prolonged PFS and OS but increased toxicity in patients with NSCLC.",2020,Estimated median OS was significantly longer with Gef+C than Gef (not reached  v  17 months,"['350 patients were randomly assigned to Gef (n = 176) and Gef+C (n = 174', 'EGFR -mutant advanced non-small-cell lung cancer (NSCLC', 'EGFR -Mutated Lung Cancer', 'Between 2016 and 2018', 'patients with advanced NSCLC harboring an  EGFR -sensitizing mutation and a performance status of 0 to 2 who were', 'patients with NSCLC']","['planned to receive first-line palliative therapy', 'pemetrexed (gefitinib plus chemotherapy [Gef+C', 'Gefitinib Versus Gefitinib Plus Pemetrexed and Carboplatin Chemotherapy', 'Gef+C', 'gefitinib 250 mg orally per day (Gef) or gefitinib 250 mg orally per day plus pemetrexed 500 mg/m 2  and carboplatin', 'pemetrexed and carboplatin chemotherapy']","['Estimated median PFS', 'hazard ratio for death', 'brain metastases', 'overall survival (OS), response rate, and toxicity', 'Radiologic response rates', 'progression-free survival (PFS', 'hazard ratio for disease progression or death', 'Clinically relevant grade 3 or greater toxicities', 'Estimated median OS', 'toxicity']","[{'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C4517604', 'cui_str': 'One hundred and seventy-four'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0475311', 'cui_str': 'Harbor (environment)'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]","[{'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0030231', 'cui_str': 'Palliative Supportive Care'}, {'cui': 'C1122962', 'cui_str': 'gefitinib'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C1176914', 'cui_str': 'gefitinib 250 MG'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C4074670', 'cui_str': 'pemetrexed 500 MG'}]","[{'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0220650', 'cui_str': 'Secondary malignant neoplasm of brain (disorder)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0205483', 'cui_str': 'Radiologic (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}]",350.0,0.130639,Estimated median OS was significantly longer with Gef+C than Gef (not reached  v  17 months,"[{'ForeName': 'Vanita', 'Initials': 'V', 'LastName': 'Noronha', 'Affiliation': 'Tata Memorial Center, Mumbai, India.'}, {'ForeName': 'Vijay Maruti', 'Initials': 'VM', 'LastName': 'Patil', 'Affiliation': 'Tata Memorial Center, Mumbai, India.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Joshi', 'Affiliation': 'Tata Memorial Center, Mumbai, India.'}, {'ForeName': 'Nandini', 'Initials': 'N', 'LastName': 'Menon', 'Affiliation': 'Tata Memorial Center, Mumbai, India.'}, {'ForeName': 'Anuradha', 'Initials': 'A', 'LastName': 'Chougule', 'Affiliation': 'Tata Memorial Center, Mumbai, India.'}, {'ForeName': 'Abhishek', 'Initials': 'A', 'LastName': 'Mahajan', 'Affiliation': 'Tata Memorial Center, Mumbai, India.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Janu', 'Affiliation': 'Tata Memorial Center, Mumbai, India.'}, {'ForeName': 'Nilendu', 'Initials': 'N', 'LastName': 'Purandare', 'Affiliation': 'Tata Memorial Center, Mumbai, India.'}, {'ForeName': 'Rajiv', 'Initials': 'R', 'LastName': 'Kumar', 'Affiliation': 'Tata Memorial Center, Mumbai, India.'}, {'ForeName': 'Sucheta', 'Initials': 'S', 'LastName': 'More', 'Affiliation': 'Tata Memorial Center, Mumbai, India.'}, {'ForeName': 'Supriya', 'Initials': 'S', 'LastName': 'Goud', 'Affiliation': 'Tata Memorial Center, Mumbai, India.'}, {'ForeName': 'Nandkumar', 'Initials': 'N', 'LastName': 'Kadam', 'Affiliation': 'Gunvati J. Kapoor Medical Relief Charitable Foundation, Mumbai, India.'}, {'ForeName': 'Nilesh', 'Initials': 'N', 'LastName': 'Daware', 'Affiliation': 'Gunvati J. Kapoor Medical Relief Charitable Foundation, Mumbai, India.'}, {'ForeName': 'Atanu', 'Initials': 'A', 'LastName': 'Bhattacharjee', 'Affiliation': 'Tata Memorial Center, Mumbai, India.'}, {'ForeName': 'Srushti', 'Initials': 'S', 'LastName': 'Shah', 'Affiliation': 'Tata Memorial Center, Mumbai, India.'}, {'ForeName': 'Akanksha', 'Initials': 'A', 'LastName': 'Yadav', 'Affiliation': 'Tata Memorial Center, Mumbai, India.'}, {'ForeName': 'Vaishakhi', 'Initials': 'V', 'LastName': 'Trivedi', 'Affiliation': 'Tata Memorial Center, Mumbai, India.'}, {'ForeName': 'Vichitra', 'Initials': 'V', 'LastName': 'Behel', 'Affiliation': 'Tata Memorial Center, Mumbai, India.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Dutt', 'Affiliation': 'Advanced Centre for Treatment, Research and Education in Cancer, Navi Mumbai, India.'}, {'ForeName': 'Shripad Dinanath', 'Initials': 'SD', 'LastName': 'Banavali', 'Affiliation': 'Tata Memorial Center, Mumbai, India.'}, {'ForeName': 'Kumar', 'Initials': 'K', 'LastName': 'Prabhash', 'Affiliation': 'Tata Memorial Center, Mumbai, India.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.01154']
1021,32440816,"Omega-3 fatty acids reduce post-operative risk of deep vein thrombosis and pulmonary embolism after surgery for elderly patients with proximal femoral fractures: a randomized placebo-controlled, double-blind clinical trial.","BACKGROUND


Elderly patients with proximal femoral fractures face elevated risk of post-operative deep vein thrombosis and pulmonary embolism, due to the lack of suitable treatment plans after surgery and hospital discharge. This study aimed to investigate the effect of omega-3 fatty acid supplementation in the above-described clinical setting.
METHODS


Five hundred and seven elderly patients (> 60 years of age) suffering from proximal femoral fractures were recruited. After exclusion, 452 eligible patients were assigned in a random manner to receive either omega-3 fatty acids at the daily dose of 1000 mg or placebo, via oral administration for a period of 30 days after surgery. At the end of intervention, the incidences of pulmonary embolism, deep vein thrombosis, and other related complications were compared between the two study groups.
RESULTS


Incidences of pulmonary embolism as well as deep vein thrombosis, including events leading to fatality, were significantly reduced by the 30-day omega-3 fatty acid intervention. But other related complications, such as haematoma evacuation, post-operative wound bleed, wound infection with frank pus, and other bleed events that required transfusion, were not affected after omega-3 fatty acid consumption.
CONCLUSION


Daily supplementation of omega-3 fatty acids decreases the risk of pulmonary embolism as well as symptomatic deep vein thrombosis, after surgery among elderly patients with proximal femoral fractures, without causing elevated risk of bleeding episodes.",2020,"RESULTS


Incidences of pulmonary embolism as well as deep vein thrombosis, including events leading to fatality, were significantly reduced by the 30-day omega-3 fatty acid intervention.","['elderly patients with proximal femoral fractures', '452 eligible patients', 'Elderly patients with proximal femoral fractures', 'Five hundred and seven elderly patients (> 60 years of age) suffering from proximal femoral fractures were recruited']","['omega-3 fatty acids', 'Omega-3 fatty acids', 'omega-3 fatty acids at the daily dose of 1000 mg or placebo', 'omega-3 fatty acid supplementation', 'placebo']","['risk of pulmonary embolism', 'incidences of pulmonary embolism, deep vein thrombosis, and other related complications', 'deep vein thrombosis']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0015802', 'cui_str': 'Fracture of femur'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0561929', 'cui_str': 'N-3 fatty acid supplementation'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",507.0,0.273138,"RESULTS


Incidences of pulmonary embolism as well as deep vein thrombosis, including events leading to fatality, were significantly reduced by the 30-day omega-3 fatty acid intervention.","[{'ForeName': 'Xinying', 'Initials': 'X', 'LastName': 'Zheng', 'Affiliation': 'Department of Nursing, Cangzhou Central Hospital, Xinhua West Road, Cangzhou, 061000, Hebei, China.'}, {'ForeName': 'Rufu', 'Initials': 'R', 'LastName': 'Jia', 'Affiliation': 'Department of Nursing, Cangzhou Central Hospital, Xinhua West Road, Cangzhou, 061000, Hebei, China. Hlbzxy2@163.com.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesia of West Hospital, Cangzhou Central Hospital, Xinhua West Road, Cangzhou, 061000, Hebei, China.'}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesia of West Hospital, Cangzhou Central Hospital, Xinhua West Road, Cangzhou, 061000, Hebei, China.'}, {'ForeName': 'Zhijing', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesia of West Hospital, Cangzhou Central Hospital, Xinhua West Road, Cangzhou, 061000, Hebei, China.'}]",International orthopaedics,['10.1007/s00264-020-04610-0']
1022,31446143,"Ticagrelor versus placebo for the reduction of vaso-occlusive crises in pediatric sickle cell disease: Rationale and design of a randomized, double-blind, parallel-group, multicenter phase 3 study (HESTIA3).","BACKGROUND


An unmet need for therapies exists to reduce sickle cell disease (SCD) complications in pediatric patients. Activated platelets contribute to the formation of cellular aggregates during sickling and vaso-occlusive crises (VOCs). Ticagrelor is an oral, direct-acting, and reversible adenosine diphosphate P2Y 12  receptor antagonist that inhibits platelet activation and aggregation. Although ticagrelor was well tolerated in two phase 2 studies in children and young adults with SCD, larger and longer-term treatment studies are needed to assess ticagrelor's efficacy to reduce VOCs. HESTIA3 will evaluate the efficacy, safety, and tolerability of ticagrelor versus placebo over a minimum of 1 year (maximum 2 years) in pediatric patients with SCD.
METHODS


Approximately 180 patients (aged ≥ 2 to <18 years) with SCD (≥ 2 VOCs in the prior year) from 18 countries will be randomized 1:1 to ticagrelor or placebo. Primary endpoint: number of VOCs (a composite endpoint of painful crises and/or acute chest syndrome); key secondary endpoints: hospitalizations, pain intensity and analgesic use during VOCs, acceptability of formulation, and health-related quality of life. The weight-based doses of ticagrelor are set by modeling and simulation. Platelet inhibition data, measured by the vasodilator-stimulated phosphoprotein assay, will be collected for exploratory purposes.
CONCLUSIONS


HESTIA3 aims to demonstrate that using greater target platelet inhibition than previous studies on SCD, ticagrelor will decrease the frequency of VOC in pediatric patients. Trial Identifier: NCT03615924; EudraCT2017-002421-38.",2019,"Ticagrelor is an oral, direct-acting, and reversible adenosine diphosphate P2Y 12  receptor antagonist that inhibits platelet activation and aggregation.","['pediatric patients with SCD.\nMETHODS\n\n\nApproximately 180 patients (aged ≥2 to <18\u202fyears) with SCD (≥2 VOCs in the prior year) from 18 countries', 'pediatric patients', 'pediatric sickle cell disease']","['ticagrelor', 'Ticagrelor', 'placebo', 'ticagrelor or placebo', 'ticagrelor versus placebo']","['number of VOCs (a composite endpoint of painful crises', 'efficacy, safety, and tolerability', 'sickle cell disease (SCD) complications', 'pain intensity and analgesic use during VOCs, acceptability of formulation, and health-related quality of life']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0964695', 'cui_str': 's(7)(beta)CD'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0002895', 'cui_str': 'Sickle Cell Disease'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231224', 'cui_str': 'Crisis (finding)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0002895', 'cui_str': 'Sickle Cell Disease'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}]",,0.374828,"Ticagrelor is an oral, direct-acting, and reversible adenosine diphosphate P2Y 12  receptor antagonist that inhibits platelet activation and aggregation.","[{'ForeName': 'Matthew M', 'Initials': 'MM', 'LastName': 'Heeney', 'Affiliation': ""Division of Hematology/Oncology, Boston Children's Hospital, Harvard Medical School, 300 Longwood Ave, Boston, MA 02115, USA. Electronic address: matthew.heeney@childrens.harvard.edu.""}, {'ForeName': 'Miguel R', 'Initials': 'MR', 'LastName': 'Abboud', 'Affiliation': 'American University of Beirut Medical Center, Cairo Street, Beirut, Lebanon. Electronic address: ma56@aub.edu.lb.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Amilon', 'Affiliation': 'BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Pepparedsleden 1, Mölndal 431 83, Sweden. Electronic address: carl.amilon@astrazeneca.com.'}, {'ForeName': 'Marielle', 'Initials': 'M', 'LastName': 'Andersson', 'Affiliation': 'BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Pepparedsleden 1, Mölndal 431 83, Sweden. Electronic address: Marielle.Andersson@astrazeneca.com.'}, {'ForeName': 'Jessie', 'Initials': 'J', 'LastName': 'Githanga', 'Affiliation': 'Hematology and Blood Transfusion Unit, Department of Human Pathology, University of Nairobi, P. O. Box 19676, Nairobi 00202, Kenya. Electronic address: jessie.githanga@uonbi.ac.ke.'}, {'ForeName': 'Baba', 'Initials': 'B', 'LastName': 'Inusa', 'Affiliation': ""Paediatric Hematology, Guy's and St Thomas' NHS Trust, Evelina London Children's Hospital, Westminster Bridge Rd, Lambeth, London SE1 7EH, UK. Electronic address: Baba.Inusa@gstt.nhs.uk.""}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Kanter', 'Affiliation': 'Hematology-Oncology, Department of Medicine, University of Alabama at Birmingham, 2000 6th Avenue S, Birmingham, AL 35233, USA. Electronic address: kanter@musc.edu.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Leonsson-Zachrisson', 'Affiliation': 'BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Pepparedsleden 1, Mölndal 431 83, Sweden. Electronic address: Maria.Leonsson-Zachrisson@astrazeneca.com.'}, {'ForeName': 'Alan D', 'Initials': 'AD', 'LastName': 'Michelson', 'Affiliation': ""Center for Platelet Research Studies, Division of Hematology/Oncology, Boston Children's Hospital, Harvard Medical School, 300 Longwood Avenue, Karp 08213, Boston, MA 02115, USA. Electronic address: Alan.Michelson@childrens.harvard.edu.""}, {'ForeName': 'Anders R', 'Initials': 'AR', 'LastName': 'Berggren', 'Affiliation': 'BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Pepparedsleden 1, Mölndal 431 83, Sweden. Electronic address: anders.r.berggren@astrazeneca.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Contemporary clinical trials,['10.1016/j.cct.2019.105835']
1023,31456449,Effects of Citrulline Malate and Beetroot Juice Supplementation on Energy Metabolism and Blood Flow During Submaximal Resistance Exercise.,"The ergogenic effects of citrulline malate (CitMal) and beetroot juice (BEET) have been widely studied, but their effects on physiological outcomes related to resistance exercise are not fully understood. The purpose of this randomized, double-blind, crossover study was to investigate the effects of CitMal (8 g) and BEET (400 mg nitrate) on blood pressure (BP), blood flow, and energy efficiency during submaximal leg extension. Recreationally active males ( n  = 27; age: 22 ± 4 yrs) completed familiarization, followed by three testing visits. Supine and standing BP were measured upon arrival, followed by supplement ingestion, a 2-h rest period, postsupplement BP measurement, and a bout of repeated submaximal isotonic leg extensions at 25% of maximal voluntary contraction torque. Diameter (aDIAM) and blood flow (aBF) of the superficial femoral artery, and cross-sectional area (CSA) and echo intensity (EI) of the vastus lateralis, were measured before and after exercise via ultrasonography. Muscle blood flow (mBF) and oxygen consumption (mVO 2 ), along with whole-body energy expenditure (EE) and respiratory exchange ratio (RER), were measured before and during exercise via indirect calorimetry and near-infrared spectroscopy. Baseline RER values differed among treatments ( p  = 0.01); BEET was higher than CitMal ( p  = 0.01) but not PLA ( p  = 0.58); CitMal and PLA were not significantly different ( p  = 0.12). No other measurements were significantly affected by treatment (all  p  > 0.05). Results suggest that neither CitMal nor BEET significantly influence resting BP, blood flow, or metabolic efficiency during submaximal leg extension in recreationally active males.",2020,Baseline RER values differed among treatments ( p  = 0.01); BEET was higher than CitMal ( p  = 0.01) but,"['Recreationally active males ( n \u2009=\u200927; age: 22\u2009±\u20094 yrs) completed familiarization, followed by three testing visits']","['Citrulline Malate and Beetroot Juice Supplementation', 'citrulline malate (CitMal) and beetroot juice (BEET', 'CitMal (8\u2009g) and BEET (400\u2009mg nitrate']","['blood pressure (BP), blood flow, and energy efficiency', 'Baseline RER values', 'Diameter (aDIAM) and blood flow (aBF) of the superficial femoral artery, and cross-sectional area (CSA) and echo intensity (EI) of the vastus lateralis', 'Supine and standing BP', 'Energy Metabolism and Blood Flow', 'resting BP, blood flow, or metabolic efficiency', 'Muscle blood flow (mBF) and oxygen consumption (mVO 2 ), along with whole-body energy expenditure (EE) and respiratory exchange ratio (RER']","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}]","[{'cui': 'C0109943', 'cui_str': 'citrulline malate'}, {'cui': 'C0453112', 'cui_str': 'Beetroot (substance)'}, {'cui': 'C1268568', 'cui_str': 'Juice'}, {'cui': 'C0600054', 'cui_str': 'Beets'}, {'cui': 'C1318217', 'cui_str': '8G'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0028125', 'cui_str': 'Nitrates'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0447106', 'cui_str': 'Superficial femoral artery (body structure)'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0205155', 'cui_str': 'Sectional (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C0014272', 'cui_str': 'Energy Expenditure'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}, {'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C0429702', 'cui_str': 'Respiratory quotient (observable entity)'}]",,0.140576,Baseline RER values differed among treatments ( p  = 0.01); BEET was higher than CitMal ( p  = 0.01) but,"[{'ForeName': 'Eric T', 'Initials': 'ET', 'LastName': 'Trexler', 'Affiliation': 'Human Movement Science Curriculum, Department of Allied Health Sciences, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Dale S', 'Initials': 'DS', 'LastName': 'Keith', 'Affiliation': 'Applied Physiology Laboratory, Department of Exercise and Sport Science, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Adam A', 'Initials': 'AA', 'LastName': 'Lucero', 'Affiliation': 'School of Sport, Exercise and Nutrition, Massey University, Wellington, NZ.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Stoner', 'Affiliation': 'Human Movement Science Curriculum, Department of Allied Health Sciences, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Todd A', 'Initials': 'TA', 'LastName': 'Schwartz', 'Affiliation': 'Department of Biostatistics, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Adam M', 'Initials': 'AM', 'LastName': 'Persky', 'Affiliation': 'Eshelman School of Pharmacy, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Ryan', 'Affiliation': 'Human Movement Science Curriculum, Department of Allied Health Sciences, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Abbie E', 'Initials': 'AE', 'LastName': 'Smith-Ryan', 'Affiliation': 'Human Movement Science Curriculum, Department of Allied Health Sciences, University of North Carolina, Chapel Hill, NC, USA.'}]",Journal of dietary supplements,['10.1080/19390211.2019.1650866']
1024,32441171,Influence of Different Rehydration Protocols on Biomechanical Properties of Allogeneic Cortical Bone Plates: A Combined  in-vitro / in-vivo  Study.,"Introduction:  Allogeneic cortical bone plates (CP) are used for alveolar ridge augmentation. Since CP are freeze-dried and dehydrated during processing, the breaking strength (BS) and the flexibility (FX) are reduced, resulting in a relevant risk for plate fractures during insertion. The aim of this study was to evaluate the influence of rehydration time on the biomechanical properties (BS & FX) of CP  in-vitro  and  in vivo . Material and Methods:  40 CP were randomly divided into four experimental groups. (A) untreated control (n = 10), rehydration for 10 (B), 30 (C) and 60 (D) minutes in 0.9% saline solution (n = 10 each). BS [Newton, N] and FX [mm] (force till fracture and distance of deflection to the breaking point) were analyzed. Besides, architectural features of all CP groups were visualized and examined by scanning electron microscopy (SEM). In addition, the frequency of CP fractures of rehydrated- vs. non-rehydrated CP was retrospectively analyzed in 6 patients. Results:  Compared to the control group, significantly increased BS and FX were demonstrated after 10, 30 and 60 minutes of rehydration (p each ≤ 0.035). After a rehydration time of 10 minutes, no additional increase of BS and FX was seen when compared to30 and 60 minutes (p each = 1.0). SEM scans demonstrated that the CP fracture characteristics were influenced by the different rehydration protocols. The frequency of CP fractures was reduced in patients by CP rehydration. Conclusion:  The biomechanical properties of CP can be significantly improved by 10 min of rehydration, resulting in an increased BS and FX, that might be clinically relevant.",2020,"Compared to the control group, significantly increased BS and FX were demonstrated after 10, 30 and 60 minutes of rehydration (p each ≤ 0.035).",['40 CP'],['Allogeneic cortical bone plates (CP'],"['CP fracture characteristics', 'BS and FX', 'breaking strength (BS) and the flexibility (FX', 'frequency of CP fractures', 'Biomechanical Properties of Allogeneic Cortical Bone Plates']",[],"[{'cui': 'C0222652', 'cui_str': 'Cortex of bone'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}]","[{'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0871161', 'cui_str': 'Property'}, {'cui': 'C0222652', 'cui_str': 'Cortex of bone'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}]",,0.0180156,"Compared to the control group, significantly increased BS and FX were demonstrated after 10, 30 and 60 minutes of rehydration (p each ≤ 0.035).","[{'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Pabst', 'Affiliation': 'Department of Oral- and Maxillofacial Surgery, Federal Armed Forces Hospital, Koblenz, Germany.'}, {'ForeName': 'Maximilian', 'Initials': 'M', 'LastName': 'Ackermann', 'Affiliation': 'Institute of Functional and Clinical Anatomy, University Medical Center, Mainz, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Thiem', 'Affiliation': 'Department of Oral- and Maxillofacial Surgery, University Medical Center, Mainz, Germany.'}, {'ForeName': 'Peer', 'Initials': 'P', 'LastName': 'Kämmerer', 'Affiliation': 'Department of Oral- and Maxillofacial Surgery, University Medical Center, Mainz, Germany.'}]",Journal of investigative surgery : the official journal of the Academy of Surgical Research,['10.1080/08941939.2020.1767735']
1025,32441759,A smartphone game to prevent HIV among young Kenyans: local perceptions of mechanisms of effect.,"Electronic games delivered via smartphones have the potential to become valuable tools in HIV prevention in high-prevalence and low-resource international settings. To ground theoretical elaboration around novel mHealth interventions in contextual realities, it is important to understand the mechanisms of their effects as perceived by local populations. Such perspectives are particularly important when working cross-culturally. 'Tumaini' is an interactive narrative-based smartphone game that uses a 'choose-your-own-adventure' format. It is designed to prevent HIV among young African adolescents (aged 11-14) by increasing age and condom use at first sex. It was developed with a US-based commercial game developer and is grounded in social behavioral theory, evidence-based practice and contextually relevant scenarios. In a 2017 randomized pilot study (n = 60) in Western Kenya, 'Tumaini' showed promising effects on behavioral mediators of sexual debut. In subsequent focus group discussions, adolescent participants and their parents shared their perceptions of the game's mechanisms of effect, which included motivation to play, future orientation, decision-making, relationship to a diverse range of characters and a bridging of the virtual and real worlds. These findings align with our theoretical framework, confirm its successful translation into the intervention and will inform mediation analyses in an upcoming efficacy trial.",2020,"In a 2017 randomized pilot study (n = 60) in Western Kenya, 'Tumaini' showed promising effects on behavioral mediators of sexual debut.","[""2017 randomized pilot study (n\u2009=\u200960) in Western Kenya, 'Tumaini"", 'young African adolescents (aged 11-14) by increasing age and condom use at first sex']",[],['behavioral mediators of sexual debut'],"[{'cui': 'C0031928', 'cui_str': 'Pilot Study'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}]",[],"[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}]",,0.0581283,"In a 2017 randomized pilot study (n = 60) in Western Kenya, 'Tumaini' showed promising effects on behavioral mediators of sexual debut.","[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Winskell', 'Affiliation': 'Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta, GA 30322, USA.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Sabben', 'Affiliation': 'Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta, GA 30322, USA.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Akelo', 'Affiliation': 'Kenya Medical Research Institute, Centre for Global Health Research, HIV Research Branch, Kisumu, Kenya.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': ""Ondeng'e"", 'Affiliation': 'Kenya Medical Research Institute, Centre for Global Health Research, HIV Research Branch, Kisumu, Kenya.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Odero', 'Affiliation': 'Kenya Medical Research Institute, Centre for Global Health Research, HIV Research Branch, Kisumu, Kenya.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Mudhune', 'Affiliation': 'Kenya Medical Research Institute, Centre for Global Health Research, HIV Research Branch, Kisumu, Kenya.'}]",Health education research,['10.1093/her/cyaa011']
1026,31425751,"A randomized pragmatic clinical trial of gestational diabetes screening (ScreenR2GDM): Study design, baseline characteristics, and protocol adherence.","BACKGROUND


ScreenR2GDM is a pragmatic randomized clinical trial designed to investigate if one of two gestational diabetes (GDM) screening and treatment protocols results in improved outcomes in the context of standard clinical care.
METHODS


Pregnant women are randomized to one of two GDM screening strategies: 1-step: 2-h, 75 g, oral glucose tolerance test (OGTT) or 2-step: 1-h, 50 g glucose challenge test (GCT) followed by 3-h, 100 g OGTT if GCT-positive. Providers are prompted within the electronic medical record to order the assigned test but were given the option to order the alternate test. Collected data include maternal and pregnancy characteristics, GDM testing, and outcomes for mother and newborn. We describe the study design and baseline characteristics and evaluate characteristics associated with adhering to the randomized protocol.
RESULTS


Baseline characteristics of the 23,792 randomized pregnancies were comparable between the two groups. Adherence to assigned test differed between the two strategies: 66.1% for 1-step and 91.7% for 2-step (p < .0001). 27% of the women randomized to receive the 1-step completed the 2-step test vs 2% randomized to the 2-step who completed the 1-step (p < .0001). Patient characteristics related to adherence included obesity, age, prior GDM, Medicaid insurance, race and nulliparity. Clinician characteristics related to adherence included provider type, age and gender.
CONCLUSIONS


Both patient and provider characteristics were related to adherence to the randomized GDM screening protocol. Analytical techniques that incorporate these findings into the formal evaluation of the two protocols on GDM-associated outcomes will be necessary to account for potential biases introduced by non-adherence.",2019,Adherence to assigned test differed between the two strategies: 65.9% for 1-step and 90.5% for 2-step (p < .0001).,['Pregnant women'],"['GDM screening strategies: 1-step: 2-h, 75\u202fg, oral glucose tolerance test (OGTT) or 2-step: 1-h, 50\u202fg glucose challenge test (GCT', 'gestational diabetes screening (ScreenR2GDM']","['maternal and pregnancy characteristics, GDM testing, and outcomes for mother and newborn']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}]","[{'cui': 'C0085207', 'cui_str': 'Diabetes, Pregnancy-Induced'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0700308', 'cui_str': 'Protium (substance)'}, {'cui': 'C0017741', 'cui_str': 'Glucose tolerance test (procedure)'}, {'cui': 'C0439671', 'cui_str': 'Gestational (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}]","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0085207', 'cui_str': 'Diabetes, Pregnancy-Induced'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}]",,0.130347,Adherence to assigned test differed between the two strategies: 65.9% for 1-step and 90.5% for 2-step (p < .0001).,"[{'ForeName': 'Kathryn L', 'Initials': 'KL', 'LastName': 'Pedula', 'Affiliation': 'Center for Health Research, Kaiser Permanente Northwest, 3800 N Interstate Ave, Portland, OR 97227, USA. Electronic address: kathy.pedula@kp.org.'}, {'ForeName': 'Teresa A', 'Initials': 'TA', 'LastName': 'Hillier', 'Affiliation': 'Center for Health Research, Kaiser Permanente Northwest, 3800 N Interstate Ave, Portland, OR 97227, USA. Electronic address: teresa.hillier@kpchr.org.'}, {'ForeName': 'Keith K', 'Initials': 'KK', 'LastName': 'Ogasawara', 'Affiliation': 'Department of Obstetrics & Gynecology, Hawaii Permanente Medical Group, Kaiser Permanente, 3288 Moanalua Road, Honolulu, HI 96819, USA. Electronic address: keith.k.ogasawara@kp.org.'}, {'ForeName': 'Kimberly K', 'Initials': 'KK', 'LastName': 'Vesco', 'Affiliation': 'Center for Health Research, Kaiser Permanente Northwest, 3800 N Interstate Ave, Portland, OR 97227, USA. Electronic address: kimberly.k.vesco@kpchr.org.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Lubarsky', 'Affiliation': 'Department of Perinatology, Northwest Permanente, Kaiser Permanente, 10180 SE Sunnyside Rd, Clackamas, OR 97015, USA. Electronic address: suzanne.l.lubarsky@kp.org.'}, {'ForeName': 'Caryn E S', 'Initials': 'CES', 'LastName': 'Oshiro', 'Affiliation': 'Center for Health Research, Kaiser Permanente Hawaii, 501 Alakawa St, Suite 201, Honolulu, HI 96817, USA. Electronic address: caryn.es.oshiro@kp.org.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'VanMarter', 'Affiliation': 'Center for Health Research, Kaiser Permanente Northwest, 3800 N Interstate Ave, Portland, OR 97227, USA. Electronic address: jan.vanmarter@kpchr.org.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105829']
1027,32437568,Association of motivations and barriers with participation and performance in a pedometer-based intervention.,"BACKGROUND


A randomized trial of a pedometer-based intervention with weekly activity goals led to increased walking among dialysis patients. However, the association of participant-expressed motivations and barriers to participation and performance in such an intervention has not been determined.
METHODS


Thirty dialysis patients were randomized to a 12-week pedometer-based intervention with weekly step goals. Participants were asked about motivations and barriers to the increasing activity via weekly semi-scripted telephone interviews. We examined the association of these motivations and barriers with achieving weekly goals, reaching overall targets and increasing steps through multivariable linear and logistic regression analyses adjusted for age, sex, body mass index, dialysis modality and baseline steps.
RESULTS


The most common motivations were desire to maintain/improve functional ability (30%) and activity (30%). The most common barriers were health-related (33%). Motivation to maintain/improve functional ability was associated with achieving weekly goals 17.9% more often [95% confidence interval (CI) 1.7-34.2] and with a greater increase in steps (1524 steps; 95% CI 61-2989) than those lacking this motivation. Experiencing a health-related barrier was not associated with the decreased achievement of weekly goals but was associated with lower odds of reaching overall targets (odds ratio = 0.06; 95% CI 0.01-0.53) and a smaller increase in steps (-1640 steps, 95% CI -3244 to -36). No patients who reported weather/environmental barriers or safety concerns reached overall targets.
CONCLUSIONS


Participants who express a desire to maintain/improve functional ability may be particularly suited for activity interventions. Health-related setbacks should be met with revised goals. Reporting environmental or safety concerns may merit lowering overall targets.",2020,Motivation to maintain/improve functional ability was associated with achieving weekly goals 17.9% more often [95% confidence interval (CI) 1.7-34.2] and with a greater increase in steps (1524 steps; 95% CI 61-2989) than those lacking this motivation.,"['dialysis patients', 'Thirty dialysis patients']",[],"['Motivation to maintain/improve functional ability', 'functional ability']","[{'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816446', 'cui_str': '30'}]",[],"[{'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}]",,0.0511484,Motivation to maintain/improve functional ability was associated with achieving weekly goals 17.9% more often [95% confidence interval (CI) 1.7-34.2] and with a greater increase in steps (1524 steps; 95% CI 61-2989) than those lacking this motivation.,"[{'ForeName': 'Anoop', 'Initials': 'A', 'LastName': 'Sheshadri', 'Affiliation': 'Department of Medicine, Division of Nephrology, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Piyawan', 'Initials': 'P', 'LastName': 'Kittiskulnam', 'Affiliation': 'Department of Medicine-Division of Nephrology, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Delgado', 'Affiliation': 'Department of Medicine, Division of Nephrology, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Sudore', 'Affiliation': 'Department of Medicine, Division of Nephrology, San Francisco Veterans Affairs Medical Center, San Francisco, CA, USA.'}, {'ForeName': 'Jennifer C', 'Initials': 'JC', 'LastName': 'Lai', 'Affiliation': 'Department of Medicine, Division of Gastroenterology/Hepatology, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Kirsten L', 'Initials': 'KL', 'LastName': 'Johansen', 'Affiliation': 'Division of Nephrology, Hennepin County Medical Center, Minneapolis, MN, USA.'}]","Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association",['10.1093/ndt/gfaa047']
1028,32437569,Physical activity and risk of cardiovascular events and all-cause mortality among kidney transplant recipients.,"BACKGROUND


Insufficient physical activity (PA) may increase the risk of all-cause mortality and cardiovascular disease (CVD) morbidity and mortality among kidney transplant recipients (KTRs), but limited research is available. We examine the relationship between PA and the development of CVD events, CVD death and all-cause mortality among KTRs.
METHODS


A total of 3050 KTRs enrolled in an international homocysteine-lowering randomized controlled trial were examined (38% female; mean age 51.8 ± 9.4 years; 75% white; 20% with prevalent CVD). PA was measured at baseline using a modified Yale Physical Activity Survey, divided into tertiles (T1, T2 and T3) from lowest to highest PA. Kaplan-Meier survival curves were used to graph the risk of events; Cox proportional hazards regression models examined the association of baseline PA levels with CVD events (e.g. stroke, myocardial infarction), CVD mortality and all-cause mortality over time.
RESULTS


Participants were followed up to 2500 days (mean 3.7 ± 1.6 years). The cohort experienced 426 CVD events and 357 deaths. Fully adjusted models revealed that, compared to the lowest tertile of PA, the highest tertile experienced a significantly lower risk of CVD events {hazard ratio [HR] 0.76 [95% confidence interval (CI) 0.59-0.98]}, CVD mortality [HR 0.58 (95% CI 0.35-0.96)] and all-cause mortality [HR 0.76 (95% CI 0.59-0.98)]. Results were similar in unadjusted models.
CONCLUSIONS


PA was associated with a reduced risk of CVD events and all-cause mortality among KTRs. These observed associations in a large, international sample, even when controlling for traditional CVD risk factors, indicate the potential importance of PA in reducing CVD and death among KTRs.",2020,"Fully adjusted models revealed that, compared to the lowest tertile of PA, the highest tertile experienced a significantly lower risk of CVD events {hazard ratio [HR] 0.76","['A total of 3050 KTRs enrolled in an international homocysteine-lowering randomized controlled trial were examined (38% female', 'kidney transplant recipients (KTRs', 'kidney transplant recipients', 'mean age 51.8\u2009±\u20099.4\u2009years; 75% white; 20% with prevalent CVD', 'Participants were followed up to 2500\u2009days (mean 3.7\u2009±\u20091.6\u2009years']",[],"['PA', 'Physical activity and risk of cardiovascular events', 'baseline PA levels with CVD events (e.g. stroke, myocardial infarction), CVD mortality and all-cause mortality', 'Kaplan-Meier survival curves', 'reduced risk of CVD events', 'CVD mortality ']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0019878', 'cui_str': 'Homocysteine'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C4319601', 'cui_str': '2500'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4517696', 'cui_str': '3.7'}, {'cui': 'C4517508', 'cui_str': '1.6'}]",[],"[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]",3050.0,0.0529124,"Fully adjusted models revealed that, compared to the lowest tertile of PA, the highest tertile experienced a significantly lower risk of CVD events {hazard ratio [HR] 0.76","[{'ForeName': 'Augustine W', 'Initials': 'AW', 'LastName': 'Kang', 'Affiliation': 'Center for Health Equity Research, Brown University School of Public Health, Providence, RI, USA.'}, {'ForeName': 'Andrew G', 'Initials': 'AG', 'LastName': 'Bostom', 'Affiliation': 'Department of Family Medicine, Warren Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Hongseok', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Department of Epidemiology, Brown University School of Public Health, Providence, RI, USA.'}, {'ForeName': 'Charles B', 'Initials': 'CB', 'LastName': 'Eaton', 'Affiliation': 'Department of Family Medicine, Warren Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Reginald', 'Initials': 'R', 'LastName': 'Gohh', 'Affiliation': 'Division of Nephrology, Rhode Island Hospital, Providence, RI, USA.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Kusek', 'Affiliation': 'Department of Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Marc A', 'Initials': 'MA', 'LastName': 'Pfeffer', 'Affiliation': ""Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Patricia M', 'Initials': 'PM', 'LastName': 'Risica', 'Affiliation': 'Center for Health Equity Research, Brown University School of Public Health, Providence, RI, USA.'}, {'ForeName': 'Carol E', 'Initials': 'CE', 'LastName': 'Garber', 'Affiliation': ""Teachers' College, Columbia University, New York, NY, USA.""}]","Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association",['10.1093/ndt/gfaa038']
1029,32441760,"A peer navigation intervention to prevent HIV among mixed immigrant status Latinx GBMSM and transgender women in the United States: outcomes, perspectives and implications for PrEP uptake.","The Latinx population in the United States is disproportionately affected by HIV. Our community-based participatory research partnership developed, implemented and evaluated a Spanish-language peer navigation intervention designed to increase HIV testing and condom use among social networks of immigrant Spanish-speaking Latinx gay, bisexual and other men who have sex with men (GBMSM) and transgender women (TW). We randomized 21 social networks of Latinx GBMSM and TW, ages 18-55 years, to the intervention, known as HOLA, or a waitlist control group. Social network participants (n = 166) completed structured assessments at baseline and 12-month follow-up (24 months after baseline). Follow-up retention was 95%. Individual in-depth interviews with a sample of participants documented their intervention-related experiences, needs, and priorities to inform future research. At follow-up, HOLA participants reported increased HIV testing (adjusted odds ratio = 8.3; 95% CI = 3.0-23.0; P < 0.0001). All study participants reported increased condom use; there was no significant difference between HOLA and waitlist control participants. In-depth interviews identified critical intervention elements and impacts and community needs and priorities. The HOLA intervention is effective for increasing HIV testing among Latinx GBMSM and TW, an initial step within the HIV prevention and care continua, and may be adaptable to promote pre-exposure prophylaxis uptake.",2020,"At follow-up, HOLA participants reported increased HIV testing (adjusted odds ratio = 8.3; 95% CI = 3.0-23.0; P < 0.0001).","['Social network participants (n\u2009=\u2009166', 'immigrant Spanish-speaking Latinx gay, bisexual and other men who have sex with men (GBMSM) and transgender women (TW']","['HOLA intervention', 'peer navigation intervention']",['HIV testing'],"[{'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C5191361', 'cui_str': '166'}, {'cui': 'C0282163', 'cui_str': 'Immigrant'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0019898', 'cui_str': 'Queers'}, {'cui': 'C0005639', 'cui_str': 'Bisexuality'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C1319927', 'cui_str': 'Male-to-female transsexual'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0459958', 'cui_str': 'HIV screening'}]",21.0,0.0335094,"At follow-up, HOLA participants reported increased HIV testing (adjusted odds ratio = 8.3; 95% CI = 3.0-23.0; P < 0.0001).","[{'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Rhodes', 'Affiliation': 'Department of Social Sciences and Health Policy, Wake Forest School of Medicine, Medical Center Boulevard, Winston-Salem, NC 27157, USA.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Alonzo', 'Affiliation': 'Department of Social Sciences and Health Policy, Wake Forest School of Medicine, Medical Center Boulevard, Winston-Salem, NC 27157, USA.'}, {'ForeName': 'Lilli', 'Initials': 'L', 'LastName': 'Mann-Jackson', 'Affiliation': 'Department of Social Sciences and Health Policy, Wake Forest School of Medicine, Medical Center Boulevard, Winston-Salem, NC 27157, USA.'}, {'ForeName': 'Eunyoung Y', 'Initials': 'EY', 'LastName': 'Song', 'Affiliation': 'Department of Social Sciences and Health Policy, Wake Forest School of Medicine, Medical Center Boulevard, Winston-Salem, NC 27157, USA.'}, {'ForeName': 'Amanda E', 'Initials': 'AE', 'LastName': 'Tanner', 'Affiliation': 'Department of Public Health Education, University of North Carolina Greensboro, Greensboro, NC 27402, USA.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Garcia', 'Affiliation': 'Department of Social Sciences and Health Policy, Wake Forest School of Medicine, Medical Center Boulevard, Winston-Salem, NC 27157, USA.'}, {'ForeName': 'Benjamin D', 'Initials': 'BD', 'LastName': 'Smart', 'Affiliation': 'Department of Social Sciences and Health Policy, Wake Forest School of Medicine, Medical Center Boulevard, Winston-Salem, NC 27157, USA.'}, {'ForeName': 'Logan S', 'Initials': 'LS', 'LastName': 'Baker', 'Affiliation': 'Department of Social Sciences and Health Policy, Wake Forest School of Medicine, Medical Center Boulevard, Winston-Salem, NC 27157, USA.'}, {'ForeName': 'Eugenia', 'Initials': 'E', 'LastName': 'Eng', 'Affiliation': 'Department of Health Behavior, University of North Carolina at Chapel Hill, Rosenau Hall, Chapel Hill, NC 27599, USA.'}, {'ForeName': 'Beth A', 'Initials': 'BA', 'LastName': 'Reboussin', 'Affiliation': 'Department of Social Sciences and Health Policy, Wake Forest School of Medicine, Medical Center Boulevard, Winston-Salem, NC 27157, USA.'}]",Health education research,['10.1093/her/cyaa010']
1030,31422724,"The Effect of Broad-Spectrum Dietary Supplementation on Quality of Life, Symptom Severity, and Functioning in Multiple Sclerosis.","Multiple sclerosis (MS) is a progressive neurodegenerative disease that exerts a significant quality-of-life toll on patients. According to the literature, broad-spectrum dietary supplementation including a variety of nutrients, polysaccharides, and compounds may improve the quality of life, functionality, and symptom severity in people with MS. Individuals ( n  = 15) diagnosed with relapsing-remitting MS (RRMS) for an average of 12.4 years (SD = 7.4; R = 2, 25) were enrolled in a one-year open-label clinical trial in which they consumed a broad-spectrum dietary supplement regimen three times daily. Participants were assessed at baseline and at 3, 6, 9, and 12 months with the following: (1) Functional Assessment of MS (FAMS), (2) the EQ-5D-3L, (3) Beck Depression Inventory-II (BDI), (4) Health Conditions Discomfort Scale (HCDS), and (5) Self-Assessment of Severity of MS Symptoms Scale (SASMSSS). Participants included seven females and eight males (M age = 51.3 years; SD = 7.2; R = 38, 65). Few minor gastrointestinal effects were reported. At the end of the intervention, participants showed significant improvements in all outcome measures, particularly functionality on the FAMS, overall quality of life on the EQ-5D-3L, fewer depressive symptoms on the BDI, and improved severity of symptoms on the HCDS and the SASMSSS. Our results suggest that dietary supplementation containing a variety of nutrients can improve the quality of life, severity of disease symptoms, and functionality in MS patients. These findings are clinically promising for MS patients, given the lack of treatment options geared toward improving quality of life in this population.",2020,"At the end of the intervention, participants showed significant improvements in all outcome measures, particularly functionality on the FAMS, overall quality of life on the EQ-5D-3L, fewer depressive symptoms on the BDI, and improved severity of symptoms on the HCDS and the SASMSSS.","['Participants included seven females and eight males (M age\u2009=\u200951.3\u2009years; SD\u2009=\u20097.2; R\u2009=\u200938, 65', 'Individuals ( n \u2009=\u200915) diagnosed with relapsing-remitting MS (RRMS) for an average of 12.4\u2009years (SD\u2009=\u20097.4; R\u2009=\u20092, 25) were enrolled in a one-year open-label clinical trial in which they consumed a broad-spectrum dietary supplement regimen three times daily', 'people with MS']",['Broad-Spectrum Dietary Supplementation'],"['3) Beck Depression Inventory-II (BDI), (4) Health Conditions Discomfort Scale (HCDS), and (5) Self-Assessment of Severity of MS Symptoms Scale (SASMSSS', 'Quality of Life, Symptom Severity, and Functioning in Multiple Sclerosis', 'quality of life, severity of disease symptoms, and functionality', 'quality of life', 'Functional Assessment of MS (FAMS), (2) the EQ-5D-3L', 'quality of life, functionality, and symptom severity', 'FAMS, overall quality of life on the EQ-5D-3L, fewer depressive symptoms on the BDI, and improved severity of symptoms on the HCDS and the SASMSSS']","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517857', 'cui_str': '7.2 (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0439600', 'cui_str': 'Remitting (qualifier value)'}, {'cui': 'C4517543', 'cui_str': '12.4 (qualifier value)'}, {'cui': 'C4517858', 'cui_str': '7.4'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0242295', 'cui_str': 'Dietary Supplementations'}, {'cui': 'C0556984', 'cui_str': 'Three times daily (qualifier value)'}]","[{'cui': 'C0242295', 'cui_str': 'Dietary Supplementations'}]","[{'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C0222045'}, {'cui': 'C0036591', 'cui_str': 'Self Assessment (Psychology)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0034380'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205388', 'cui_str': 'Few (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}]",,0.0337888,"At the end of the intervention, participants showed significant improvements in all outcome measures, particularly functionality on the FAMS, overall quality of life on the EQ-5D-3L, fewer depressive symptoms on the BDI, and improved severity of symptoms on the HCDS and the SASMSSS.","[{'ForeName': 'H Reginald', 'Initials': 'HR', 'LastName': 'McDaniel', 'Affiliation': 'Wellness Quest, LLC, Grand Prairie, TX, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'LaGanke', 'Affiliation': 'North Central Neurology, Inc, Cullman, AL, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Bloom', 'Affiliation': 'Department of Medicine, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Goldberg', 'Affiliation': 'Department of Medicine, University of New Mexico School of Medicine, Albuquerque, NM, USA.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Hensel', 'Affiliation': 'North Central Neurology, Inc, Cullman, AL, USA.'}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Lantigua', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Lucas C', 'Initials': 'LC', 'LastName': 'Lages', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Atlas', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Judi M', 'Initials': 'JM', 'LastName': 'Woolger', 'Affiliation': 'Department of Medicine, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Lewis', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Miami Miller School of Medicine, Miami, FL, USA.'}]",Journal of dietary supplements,['10.1080/19390211.2019.1651435']
1031,31419427,Effects of physical exercise on negative emotional susceptibility in young adult females: An event-related potential study.,"The present study investigated whether habitual physical exercise can regulate susceptibility to negative emotions in young adult female participants. Female participants with and without long-term physical exercise habits were recruited and assigned to exercise and non-exercise groups, respectively. All participants performed a standard/deviant distinction task in which the emotional valence of the deviants could be highly negative (HN), moderately negative (MN), or neutral. Event-related potentials (ERPs) elicited by deviants were recorded and compared between the two groups. Regardless of the emotional valence of the deviants, the exercise group exhibited shorter reaction times (RTs) and greater parietal P3 responses to all deviants, compared to the non-exercise group, consistent with a superiority in detecting and responding to deviants. Importantly, whereas the non-exercise group showed greater frontal-central N2 responses to MN deviant stimuli than to neutral deviant stimuli, such a difference was not observed in the exercise group, indicating that the participants who exercised regularly had decreased attentional capture and allocation to MN deviants, and thus an apparent decreased negative emotional susceptibility selectively to moderately negative emotional stimuli. These results may indicate an effect of physical exercise on the processing of negative emotional information and support the promotion of physical exercise in the maintenance of mental health in females.",2019,"Regardless of the emotional valence of the deviants, the exercise group exhibited shorter reaction times (RTs) and greater parietal P3 responses to all deviants, compared to the non-exercise group, consistent with a superiority in detecting and responding to deviants.","['mental health in females', 'young adult females', 'Female participants with and without long-term physical exercise habits', 'young adult female participants']","['physical exercise', 'habitual physical exercise', 'standard/deviant distinction task in which the emotional valence of the deviants could be highly negative (HN), moderately negative (MN), or neutral']","['negative emotional susceptibility', 'attentional capture and allocation to MN deviants', 'frontal-central N2 responses', 'shorter reaction times (RTs) and greater parietal P3 responses']","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0018464', 'cui_str': 'Habits'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205353', 'cui_str': 'Habitual (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}]","[{'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C1264642', 'cui_str': 'Susceptibility (property) (qualifier value)'}, {'cui': 'C0205123', 'cui_str': 'Coronal (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0442030', 'cui_str': 'Parietal (qualifier value)'}]",,0.0307697,"Regardless of the emotional valence of the deviants, the exercise group exhibited shorter reaction times (RTs) and greater parietal P3 responses to all deviants, compared to the non-exercise group, consistent with a superiority in detecting and responding to deviants.","[{'ForeName': 'Fanghui', 'Initials': 'F', 'LastName': 'Qiu', 'Affiliation': 'Key Laboratory of Exercise and Health Sciences, Ministry of Education, Shanghai University of Sport, Shanghai 200438, China.'}, {'ForeName': 'Weiwei', 'Initials': 'W', 'LastName': 'Peng', 'Affiliation': 'School of Psychology, Shenzhen University, Shenzhen 518060, China.'}, {'ForeName': 'Manman', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Key Laboratory of Exercise and Health Sciences, Ministry of Education, Shanghai University of Sport, Shanghai 200438, China.'}, {'ForeName': 'Lanlan', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Key Laboratory of Exercise and Health Sciences, Ministry of Education, Shanghai University of Sport, Shanghai 200438, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Zhu', 'Affiliation': 'Key Laboratory of Exercise and Health Sciences, Ministry of Education, Shanghai University of Sport, Shanghai 200438, China.'}, {'ForeName': 'Xiaoying', 'Initials': 'X', 'LastName': 'Tan', 'Affiliation': 'School of Physical Education and Coaching, Shanghai University of Sport, Shanghai 200438, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'School of Psychology, Shenzhen University, Shenzhen 518060, China; Center for Language and Brain, Shenzhen Institute of Neuroscience, Shenzhen 518057, China. Electronic address: lihongszu@szu.edu.cn.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Key Laboratory of Exercise and Health Sciences, Ministry of Education, Shanghai University of Sport, Shanghai 200438, China. Electronic address: zhangjian@sus.edu.cn.'}]",Brain research,['10.1016/j.brainres.2019.146382']
1032,32118676,Is the blood pressure of right arm measured with synchronous four-limb method is equal to that with single arm method?,"OBJECTIVE


Synchronous four-limb blood pressure (BP) measurement (four-limb method) is widely used for diagnosing peripheral artery diseases in clinical practise, but it is unclear whether the BP of right arm measured with this method is similar to that measured with single arm method.
METHODS


This study included 198 in-patients (aged 18-89, mean age 60.1± 13.9 years old, 109 males). They were divided into four groups on the therapy as renin-angiotensin system inhibitor (46 patients), calcium channel blocker (43 patients), beta receptor blocker (27 patients), and combination (Com, 82 patients) groups. The patients were randomly instructed to follow one of two BP measurement proposals designed to avoid the bias induced by BP measurement order. The result with single arm method was recorded as RA-1 and that with four-limb method as RA-4. The difference between RA-4 and RA-1 was calculated as Dif-RA. The percentage increase (PI) was also calculated on the formula: (RA-4 - RA-1)/RA-1.
RESULTS


The mean Dif-RA on SBP and DBP were 1.9/1.5 mmHg. Although the levels of SBP, DBP and pulse pressure of RA-1 were different, the PI of these parameters were comparable among four treatment groups. Multivariate regression analyses showed that age and SBP of RA-1 were positive independent factors for Dif-RA on SBP.
CONCLUSION


The SBP and DBP of right arm measured with synchronous four-limb method are 1.9/1.5 mmHg higher against the single arm method in treated hypertensives, and the increase extent of BP is not associated with the used drugs.",2020,"Multivariate regression analyses showed that age and SBP of RA-1 were positive independent factors for Dif-RA on SBP.
","['198 in-patients (aged 18-89, mean age', '60.1± 13.9 years old, 109 males']","['Synchronous four-limb blood pressure (BP) measurement (four-limb method', 'renin-angiotensin system inhibitor (46 patients), calcium channel blocker (43 patients), beta receptor blocker']","['mean Dif-RA on SBP and DBP', 'levels of SBP, DBP and pulse pressure of RA-1', 'percentage increase (PI', 'RA-4 and RA-1']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517562', 'cui_str': '13.9 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0439580', 'cui_str': 'Synchronous (qualifier value)'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0005824', 'cui_str': 'Blood pressure taking (procedure)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0035096'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0006684', 'cui_str': 'Calcium Channel Blocking Drugs'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0949236', 'cui_str': 'Pulse Pressure'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",198.0,0.0195008,"Multivariate regression analyses showed that age and SBP of RA-1 were positive independent factors for Dif-RA on SBP.
","[{'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Yang', 'Affiliation': 'Department of Cardiovascular Medicine.'}, {'ForeName': 'Qinghua', 'Initials': 'Q', 'LastName': 'Wu', 'Affiliation': 'Department of Cardiovascular Medicine.'}, {'ForeName': 'Weitong', 'Initials': 'W', 'LastName': 'Hu', 'Affiliation': 'Department of Cardiovascular Medicine.'}, {'ForeName': 'Hai', 'Initials': 'H', 'LastName': 'Su', 'Affiliation': 'Department of Cardiovascular Medicine.'}]",Blood pressure monitoring,['10.1097/MBP.0000000000000439']
1033,32111181,"High thromboembolic event rate in patients with locally advanced oesophageal cancer during neoadjuvant therapy. An exploratory analysis of the prospective, randomised intergroup phase III trial SAKK 75/08.","BACKGROUND


High rates of venous thromboembolic events (VTEs), mainly in advanced disease, are reported for patients with cancer of the upper gastrointestinal tract (stomach, pancreas) and for treatment with cisplatin.
METHODS


Exploratory analysis of VTEs reported as adverse events and serious adverse events in a prospective, randomised, multicentre, multimodal phase III trial according to VTEs reported as adverse events and severe adverse events. Patients with resectable oesophageal cancer (T2N1-3, T3-4aNx) were randomized to 2 cycles of chemotherapy with docetaxel 75 mg/m 2 , cisplatin 75 mg/m 2  followed by chemo-radiotherapy (CRT) and subsequent surgery (control arm) or the same treatment with addition of cetuximab (investigational arm).
RESULTS


VTEs occurred in 26 of 300 patients included in the trial, resulting in an incidence rate (IR) of 8.7% [95% CI 5.7-12.4%]. A total of 29 VTEs were reported:13 (45%) VTEs were grade 2, 13 (45%) grade 3 and three (10%) fatal grade 5 events. 72% (21/29) of all VTEs occurred preoperatively (IR 6.7%): 14% (4/29) during chemotherapy and 59% (17/29) during CRT. In multivariable logistic regression only adenocarcinoma (IR 11.1%, 21/189 patients) compared to squamous cell cancer (IR 4.5%, 5/111 patients) was significantly associated with VTE-risk during treatment, OR 2.9 [95%CI 1.0-8.4], p = 0.046. Baseline Khorana risk score was 0 in 73% (19/26), 1-2 in 23% (6/26) and 3 in only 4% (1/26) of patients with VTEs.
CONCLUSION


A high incidence of VTEs during preoperative therapy of resectable oesophageal cancer is observed in this analysis, especially in patients with adenocarcinoma. The role of prophylactic anticoagulation during neoadjuvant therapy in resectable esophageal cancer should be further evaluated in prospective clinical trials. According to our data, which are in line with other analysis of VTE-risk in patients with oesophageal cancer patients treated with neoadjuvant cisplatin-based chemotherapy and CRT, prophylactic anticoagluation could be considered balanced against individual bleeding risks, especially in patients with adenocarcinoma. In addition to the established risk factors, oesophageal adenocarcinoma treated with neoadjuvant cisplatin-based therapy may be regarded as a high-risk situation for VTEs.
TRIAL REGISTRATION


Registered at clinicaltrials.gov, NCT01107639, on 21 April 2010.",2020,"In multivariable logistic regression only adenocarcinoma (IR 11.1%, 21/189 patients) compared to squamous cell cancer (IR 4.5%, 5/111 patients) was significantly associated with VTE-risk during treatment, OR 2.9 [95%CI 1.0-8.4], p = 0.046.","['resectable esophageal cancer', 'patients with oesophageal cancer patients treated with', 'patients with locally advanced oesophageal cancer during neoadjuvant therapy', 'patients with adenocarcinoma', 'Patients with resectable oesophageal cancer (T2N1-3, T3-4aNx', 'patients with cancer of the upper gastrointestinal tract (stomach, pancreas) and for treatment with cisplatin']","['prophylactic anticoagulation', 'neoadjuvant cisplatin-based therapy', 'neoadjuvant cisplatin-based chemotherapy and CRT', 'chemotherapy with docetaxel 75\u2009mg/m 2 , cisplatin 75\u2009mg/m 2  followed by chemo-radiotherapy (CRT) and subsequent surgery (control arm) or the same treatment with addition of cetuximab (investigational arm']","['VTEs', 'Baseline Khorana risk score', 'adverse events and severe adverse events', 'VTE-risk', 'squamous cell cancer', 'adverse events and serious adverse events']","[{'cui': 'C0546837', 'cui_str': 'Cancer of Esophagus'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant Treatment'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C3203348', 'cui_str': 'Upper Gastrointestinal Tract'}, {'cui': 'C3714551', 'cui_str': 'Stomach structure (body structure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}]","[{'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}]","[{'cui': 'C0630906', 'cui_str': 'triethoxyvinylsilane'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0751688', 'cui_str': 'Squamous Cell Cancer'}]",29.0,0.0467315,"In multivariable logistic regression only adenocarcinoma (IR 11.1%, 21/189 patients) compared to squamous cell cancer (IR 4.5%, 5/111 patients) was significantly associated with VTE-risk during treatment, OR 2.9 [95%CI 1.0-8.4], p = 0.046.","[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Fehr', 'Affiliation': 'Department of Medical Oncology and Haematology, Cantonal Hospital St. Gallen, Rorschacherstrasse 95, 9007, St. Gallen, Switzerland. Martin.Fehr@kssg.ch.'}, {'ForeName': 'Hanne', 'Initials': 'H', 'LastName': 'Hawle', 'Affiliation': 'SAKK Coordinating Center, Bern, Switzerland.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Hayoz', 'Affiliation': 'SAKK Coordinating Center, Bern, Switzerland.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Thuss-Patience', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Sabina', 'Initials': 'S', 'LastName': 'Schacher', 'Affiliation': 'Kantonsspital Winterthur, Winterthur, Switzerland.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Riera Knorrenschild', 'Affiliation': 'Universitätsklinikum Giessen und Marburg, Marburg, Germany.'}, {'ForeName': 'Donat', 'Initials': 'D', 'LastName': 'Dürr', 'Affiliation': 'Stadtspital Triemli, Zürich, Switzerland.'}, {'ForeName': 'Wolfram T', 'Initials': 'WT', 'LastName': 'Knoefel', 'Affiliation': 'Universitätsklinikum Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Rumpold', 'Affiliation': 'Krankenhaus der barmherzigen Schwestern, Linz, Austria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bitzer', 'Affiliation': 'Universitätsklinikum Tübingen, Tübingen, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Zweifel', 'Affiliation': 'Inselspital Bern, Bern, Switzerland.'}, {'ForeName': 'Panagiotis', 'Initials': 'P', 'LastName': 'Samaras', 'Affiliation': 'Universitätsspital Zürich, Zürich, Switzerland.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Mey', 'Affiliation': 'Kantonsspital Graubünden, Chur, Switzerland.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Küng', 'Affiliation': 'Hôpital Fribourgeois, Villars-sur-Glâne, Switzerland.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Winterhalder', 'Affiliation': 'Luzerner Kantonsspital, Luzern, Switzerland.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Eisterer', 'Affiliation': 'Medizinische Universität Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Viviane', 'Initials': 'V', 'LastName': 'Hess', 'Affiliation': 'Universitätsspital Basel, Basel, Switzerland.'}, {'ForeName': 'Marie-Aline', 'Initials': 'MA', 'LastName': 'Gérard', 'Affiliation': 'SAKK Coordinating Center, Bern, Switzerland.'}, {'ForeName': 'Arnoud', 'Initials': 'A', 'LastName': 'Templeton', 'Affiliation': 'Claraspital Basel, Basel, Switzerland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Stahl', 'Affiliation': 'Evang. Kliniken Essen-Mitte, Essen, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Ruhstaller', 'Affiliation': 'Department of Medical Oncology and Haematology, Cantonal Hospital St. Gallen, Rorschacherstrasse 95, 9007, St. Gallen, Switzerland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMC cancer,['10.1186/s12885-020-6623-z']
1034,32054315,Effects of pivotal response treatment on reciprocal vocal contingency in a randomized controlled trial of children with autism spectrum disorder.,"LAY ABSTRACT


A recent randomized controlled trial found that children with autism spectrum disorder who received a pivotal response treatment package showed improved language and social communication skills following the intervention. The pivotal response treatment package includes clinician-delivered and parent-implemented strategies. Reciprocal vocal contingency is an automated measure of vocal reciprocity derived from daylong audio samples from the child's natural environment. It may provide stronger and complementary evidence of the effects of the pivotal response treatment package because it is at lower risk for detection bias than parent report and brief parent-child interaction measures. The current study compared reciprocal vocal contingency for 24 children with autism spectrum disorder in the pivotal response treatment package group and 24 children with autism spectrum disorder in the control group. The pivotal response treatment package group received 24 weeks of the pivotal response treatment package intervention. The control group received their usual intervention services during that time. The groups did not differ in reciprocal vocal contingency when the intervention started or after 12 weeks of intervention. However, after 24 weeks the pivotal response treatment package group had higher ranked reciprocal vocal contingency scores than the control group. These findings are consistent with results from parent report and parent-child interaction measures obtained during the trial. The participants in the pivotal response treatment package exhibited greater vocal responsiveness to adult vocal responses to their vocalizations than the control group. Findings support the effectiveness of the pivotal response treatment package on vocal reciprocity of children with autism spectrum disorder, which may be a pivotal skill for language development.",2020,The participants in the pivotal response treatment package exhibited greater vocal responsiveness to adult vocal responses to their vocalizations than the control group.,"['24 children with autism spectrum disorder in the pivotal response treatment package group and 24 children with autism spectrum disorder in the control group', 'children with autism spectrum disorder']","['usual intervention services', 'pivotal response treatment package intervention', 'Reciprocal vocal contingency', 'pivotal response treatment package', 'reciprocal vocal contingency', 'pivotal response treatment']","['reciprocal vocal contingency', 'language and social communication skills', 'ranked reciprocal vocal contingency scores', 'vocal responsiveness to adult vocal responses']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1704710', 'cui_str': 'Package'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1704710', 'cui_str': 'Package'}]","[{'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0870313', 'cui_str': 'Communication skills'}, {'cui': 'C0699794', 'cui_str': 'Rank (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]",24.0,0.0319462,The participants in the pivotal response treatment package exhibited greater vocal responsiveness to adult vocal responses to their vocalizations than the control group.,"[{'ForeName': 'Jena', 'Initials': 'J', 'LastName': 'McDaniel', 'Affiliation': 'The University of Kansas, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Yoder', 'Affiliation': 'Vanderbilt University, USA.'}, {'ForeName': 'Madison', 'Initials': 'M', 'LastName': 'Crandall', 'Affiliation': 'Vanderbilt University, USA.'}, {'ForeName': 'Maria Estefania', 'Initials': 'ME', 'LastName': 'Millan', 'Affiliation': 'Stanford University, USA.'}, {'ForeName': 'Christina Mich', 'Initials': 'CM', 'LastName': 'Ardel', 'Affiliation': 'Stanford University, USA.'}, {'ForeName': 'Grace W', 'Initials': 'GW', 'LastName': 'Gengoux', 'Affiliation': 'Stanford University, USA.'}, {'ForeName': 'Antonio Y', 'Initials': 'AY', 'LastName': 'Hardan', 'Affiliation': 'Stanford University, USA.'}]",Autism : the international journal of research and practice,['10.1177/1362361320903138']
1035,32140719,Supplementation with Seabuckthorn Oil Augmented in 16:1n-7t Increases Serum Trans-Palmitoleic Acid in Metabolically Healthy Adults: A Randomized Crossover Dose-Escalation Study.,"BACKGROUND


In animal models cis-palmitoleic acid (9-hexadecenoic acid; 16:1n-7c), a lipokine, improves insulin sensitivity, inflammation, and lipoprotein profiles; in humans trans-palmitoleic acid (16:1n-7t) has been associated with lower incidence of type 2 diabetes. The response to dose-escalation of supplements containing cis- and trans-palmitoleic acid has not been evaluated.
OBJECTIVES


We examined dose-escalation effects of oral supplementation with seabuckthorn oil and seabuckthorn oil augmented in 16:1n-7t on serum phospholipid fatty acids (PLFAs).
METHODS


Thirteen participants (7 women and 6 men; age 48 ± 16 y, BMI 30.4 ± 3.7 kg/m2) participated in a randomized, double-blind, crossover, dose-escalation trial of unmodified seabuckthorn oils relatively high in 16:1n-7c (380, 760, and 1520 mg 16:1n-7c/d) and seabuckthorn oils augmented in 16:1n-7t (120, 240, and 480 mg 16:1n-7t/d). Each of the 3 escalation doses was provided for 3 wk, with a 4-wk washout period between the 2 supplements. At the end of each dose period, fasting blood samples were used to determine the primary outcomes (serum concentrations of the PLFAs 16:1n-7t and 16:1n-7c) and the secondary outcomes (glucose homeostasis, serum lipids, and clinical measures). Trends across doses were evaluated using linear regression.
RESULTS


Compared with baseline, supplementation with seabuckthorn oil augmented in 16:1n-7t increased phospholipid 16:1n-7t by 26.6% at the highest dose (P = 0.0343). Supplementation with unmodified seabuckthorn oil resulted in a positive trend across the dose-escalations (P-trend = 0.0199). No significant effects of either supplement were identified on blood glucose, insulin, lipids, or other clinical measures, although this dosing study was not powered to detect such effects. No carryover or adverse effects were observed.
CONCLUSIONS


Supplementation with seabuckthorn oil augmented in 16:1n-7t and unmodified seabuckthorn oil moderately increased concentrations of their corresponding PLFAs in metabolically healthy adults, supporting the use of supplementation with these fatty acids to test potential clinical effects in humans.This trial was registered at clinicaltrials.gov as NCT02311790.",2020,"No carryover or adverse effects were observed.
","['Metabolically Healthy Adults', 'metabolically healthy adults', 'Thirteen participants (7 women and 6 men; age 48\xa0±\xa016']","['seabuckthorn oils', 'unmodified seabuckthorn oil', 'oral supplementation with seabuckthorn oil and seabuckthorn oil', 'unmodified seabuckthorn oils', 'seabuckthorn oil', 'Seabuckthorn Oil', 'supplements containing cis- and trans-palmitoleic acid']","['insulin sensitivity, inflammation, and lipoprotein profiles', 'blood glucose, insulin, lipids, or other clinical measures', 'serum phospholipid fatty acids (PLFAs', 'secondary outcomes (glucose homeostasis, serum lipids, and clinical measures', 'carryover or adverse effects']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0028908', 'cui_str': 'Oils'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0069966', 'cui_str': 'C16:1n7'}]","[{'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0031676', 'cui_str': 'Phospholipids'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0019868', 'cui_str': 'Autoregulation'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",7.0,0.142098,"No carryover or adverse effects were observed.
","[{'ForeName': 'Neil K', 'Initials': 'NK', 'LastName': 'Huang', 'Affiliation': 'Jean Mayer USDA Human Nutrition Research Center on Aging, Boston, MA, USA.'}, {'ForeName': 'Nirupa R', 'Initials': 'NR', 'LastName': 'Matthan', 'Affiliation': 'Jean Mayer USDA Human Nutrition Research Center on Aging, Boston, MA, USA.'}, {'ForeName': 'Jean M', 'Initials': 'JM', 'LastName': 'Galluccio', 'Affiliation': 'Jean Mayer USDA Human Nutrition Research Center on Aging, Boston, MA, USA.'}, {'ForeName': 'Peilin', 'Initials': 'P', 'LastName': 'Shi', 'Affiliation': 'Friedman School of Nutrition Science & Policy, Tufts University, Boston, MA, USA.'}, {'ForeName': 'Alice H', 'Initials': 'AH', 'LastName': 'Lichtenstein', 'Affiliation': 'Jean Mayer USDA Human Nutrition Research Center on Aging, Boston, MA, USA.'}, {'ForeName': 'Dariush', 'Initials': 'D', 'LastName': 'Mozaffarian', 'Affiliation': 'Friedman School of Nutrition Science & Policy, Tufts University, Boston, MA, USA.'}]",The Journal of nutrition,['10.1093/jn/nxaa060']
1036,32496397,Early Inflammatory Measures and Neurodevelopmental Outcomes in Preterm Infants.,"BACKGROUND


Inflammation may be an important predictor of long-term neurodevelopment in preterm infants. The identification of specific inflammatory biomarkers that predict outcomes is an important research goal.
OBJECTIVES


The purpose of this analysis was to identify associations between an early measure of inflammation and neurodevelopment in very preterm infants and to identify differences in the relationship between inflammation and neurodevelopment based on infant gender and race.
METHODS


We conducted a secondary analysis of data from a randomized controlled trial of a caregiving intervention for preterm infants born less than 33 weeks postmenstrual age. Plasma was collected with a clinically indicated laboratory draw by neonatal intensive care unit nurses and analyzed by multiplex assay for cytokines, chemokines, and growth factors. Neurobehavior was assessed by research nurses at the time of discharge from the neonatal intensive care unit using the motor development and vigor and alertness/orientation clusters from the Neurobehavioral Assessment of the Preterm Infant. Neurodevelopment was assessed at 6 months corrected age by the developmental specialist in the hospital's neonatal follow-up clinic using the Bayley Scales of Infant Development, Third Edition. We used linear regressions to estimate the effect of cytokine levels on neurodevelopment and allowed the effects to differ by infant gender and race.
RESULTS


In a sample of 62 preterm infants with discharge neurobehavioral assessments and a sample of 40 preterm infants with 6-month neurodevelopmental assessments, we found inconsistent associations between single-time point inflammatory measures and neurobehavior or neurodevelopment in analyses of the total sample. However, regressions with interactions revealed effects for multiple inflammatory measures on early neurobehavior and neurodevelopment that differed by infant gender and race.
DISCUSSION


Although early single-time point measures of inflammation may be insufficient to predict neurodevelopment for all preterm infants, the effect of inflammation appears to differ by infant gender and race. These demographic factors may be important considerations for future studies of inflammation and neurodevelopment as well was the development of future interventions to optimize outcomes.",2020,"However, regressions with interactions revealed effects for multiple inflammatory measures on early neurobehavior and neurodevelopment that differed by infant sex and race.
","['very preterm infants', 'preterm infants born less than 33 weeks post-menstrual age', 'preterm infants', '62 preterm infants with discharge neurobehavioral assessments and a sample of 40 preterm infants with six month neurodevelopmental assessments']",['caregiving intervention'],[],"[{'cui': 'C3897192', 'cui_str': 'Very preterm infant'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0025344', 'cui_str': 'Menstruation'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C4082120', 'cui_str': 'Six months'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],62.0,0.0941311,"However, regressions with interactions revealed effects for multiple inflammatory measures on early neurobehavior and neurodevelopment that differed by infant sex and race.
","[{'ForeName': 'Marliese Dion', 'Initials': 'MD', 'LastName': 'Nist', 'Affiliation': 'Marliese Dion Nist, PhD, RNC-NIC, is Postdoctoral Scholar, The Ohio State University College of Nursing, Columbus. Abigail B. Shoben, PhD, is Associate Professor, Division of Biostatistics, The Ohio State University College of Public Health, Columbus. Rita H. Pickler, PhD, RN, FAAN, is FloAnn Sours Easton Endowed Professor of Child and Adolescent Health, The Ohio State University College of Nursing, Columbus.'}, {'ForeName': 'Abigail B', 'Initials': 'AB', 'LastName': 'Shoben', 'Affiliation': ''}, {'ForeName': 'Rita H', 'Initials': 'RH', 'LastName': 'Pickler', 'Affiliation': ''}]",Nursing research,['10.1097/NNR.0000000000000448']
1037,32045676,Predictors of Intervention Session Completion in a Randomized Clinical Trial of a Behavioral Cancer Pain Intervention.,"CONTEXT


Some patients with cancer are able to complete psychosocial pain management intervention sessions, and others find it difficult to do so.
OBJECTIVES


Conduct a secondary analysis of a randomized clinical trial (N = 178) that compared delivery formats (in-person vs. videoconference) of a pain coping skills training (PCST) intervention for patients with cancer to examine if intervention session completion predicts postintervention outcomes of pain severity and interference, psychological distress, physical well-being, and pain self-efficacy; and identify predictors (i.e., demographics, medical characteristics, baseline outcome scores) of session completion.
METHODS


Session completion (i.e., completing all four sessions vs. missing at least one session) was tested as a predictor of postintervention outcomes. Predictors of session completion were then examined.
RESULTS


In both study conditions combined, PCST session completion predicted improvement from baseline to postintervention in pain severity (β = -0.27; P = 0.03), pain interference (β = -0.25; P = 0.048), and pain self-efficacy (β = 0.23; P = 0.07). Participants in the videoconference condition were significantly more likely than those in the in-person condition to complete all sessions (83% vs. 65%; P = 0.006). Participants with at least some college education (odds ratio [OR] 4.36; P = 0.04), a diagnosis of breast cancer (OR 6.73; P = 0.04), and higher levels of pain self-efficacy (OR 2.32; P = 0.02) were more likely to complete videoconference sessions. Participants who lived closer to the medical center (OR 0.64; P = 0.07), had early stage cancer (OR 3.82; P = 0.07), and fewer medical comorbidities (OR 0.59; P = 0.04) were more likely to complete in-person sessions.
CONCLUSION


Completing PCST sessions is important for improving pain outcomes. Efforts to increase session completion (e.g., videoconference delivery) should be considered.",2020,"Participants in the videoconference condition were significantly more likely than those in the in-person condition to complete all sessions (83% vs. 65%, p=0.006).","['patients with cancer', 'patients with cancer to']","['Behavioral Cancer Pain Intervention', 'Pain Coping Skills Training (PCST) intervention']","['pain self-efficacy', 'pain severity', 'medical comorbidities', 'pain severity and interference, psychological distress, physical well-being, and pain self-efficacy', 'diagnosis of breast cancer', 'pain outcomes', 'early stage cancer', 'pain interference']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}]","[{'cui': 'C0596240', 'cui_str': 'Tumor-Related Pain'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}]",178.0,0.0630955,"Participants in the videoconference condition were significantly more likely than those in the in-person condition to complete all sessions (83% vs. 65%, p=0.006).","[{'ForeName': 'Joseph G', 'Initials': 'JG', 'LastName': 'Winger', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, North Carolina, USA. Electronic address: joseph.winger@duke.edu.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Nunez', 'Affiliation': 'Miller School of Medicine, University of Miami, Coral Gables, Florida, USA.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Kelleher', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Krista K', 'Initials': 'KK', 'LastName': 'Ingle', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Vicky', 'Initials': 'V', 'LastName': 'Gandhi', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Francis J', 'Initials': 'FJ', 'LastName': 'Keefe', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Tamara J', 'Initials': 'TJ', 'LastName': 'Somers', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, North Carolina, USA.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2020.01.020']
1038,31398441,Cardiac autonomic activity during sleep deprivation with and without caffeine administration.,"Caffeine is often consumed to mitigate degraded alertness associated with sleep deprivation. Both caffeine and sleep deprivation have been implicated in cardiovascular disease, but evidence is largely anecdotal. We determined the effects of sleep deprivation and caffeine on markers of cardiac autonomic activity. Twelve healthy young adults completed an 18-day laboratory study. They were exposed to three 48 h sessions of acute total sleep deprivation (TSD), each separated by three recovery days. In randomized, counter-balanced order, subjects received 0 mg (placebo), 200 mg, or 300 mg of caffeine at 12 h intervals during each sleep deprivation session. Every 2 h during scheduled wakefulness, a 15-minute neurobehavioral task battery was administered, during which heart rate (HR) and the high frequency (HF) component of the HR variability power spectrum (HF-HRV) were measured. Caffeine administration decreased HR and increased HF-HRV, indicating elevated parasympathetic activity. The 300 mg caffeine dose did not significantly affect autonomic activity to a greater extent than the 200 mg dose. There was no significant effect of 48 h of TSD on HR, whereas there was a small increase across hours awake in HF-HRV. There was no significant interaction of TSD with caffeine. Circadian rhythmicity in HR and HF-HRV surpassed the magnitude of the effects of caffeine and TSD. Caffeine and acute TSD thus produced only modest changes in cardiac autonomic activity, unlikely to have immediate clinical implications in healthy young adults. However, further research is needed to determine the long-term effects of chronic exposure to sleep loss and/or caffeine on cardiac health, and to determine the generalizability of our findings to non-healthy populations.",2019,The 300 mg caffeine dose did not significantly affect autonomic activity to a greater extent than the 200 mg dose.,"['healthy young adults', 'Twelve healthy young adults completed an 18-day laboratory study']","['caffeine', 'mg (placebo', 'Caffeine']","['acute total sleep deprivation (TSD', 'autonomic activity', 'elevated parasympathetic activity', 'Cardiac autonomic activity', 'cardiac autonomic activity', 'HR and increased HF-HRV']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0037316', 'cui_str': 'Sleep Deprivation'}, {'cui': 'C0039373', 'cui_str': 'Hexosaminidase A Deficiency Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",12.0,0.055929,The 300 mg caffeine dose did not significantly affect autonomic activity to a greater extent than the 200 mg dose.,"[{'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Crooks', 'Affiliation': 'Sleep and Performance Research Center, Washington State University, PO Box 1495, Spokane, WA 99210-1495, USA; Department of Physical Therapy, Eastern Washington University, 310 N. Riverpoint Blvd., Spokane, WA 99202-0002, USA. Electronic address: ecrooks@ewu.edu.'}, {'ForeName': 'Devon A', 'Initials': 'DA', 'LastName': 'Hansen', 'Affiliation': 'Sleep and Performance Research Center, Washington State University, PO Box 1495, Spokane, WA 99210-1495, USA; Elson S. Floyd College of Medicine, Washington State University, PO Box 1495, Spokane, WA 99210-1495, USA. Electronic address: devon.hansen@wsu.edu.'}, {'ForeName': 'Brieann C', 'Initials': 'BC', 'LastName': 'Satterfield', 'Affiliation': 'Social, Cognitive, and Affective Neuroscience Lab, University of Arizona College of Medicine, PO Box 245002, Tucson, AZ 85724-5002, USA. Electronic address: bsatterfield@psychiatry.arizona.edu.'}, {'ForeName': 'Matthew E', 'Initials': 'ME', 'LastName': 'Layton', 'Affiliation': 'Sleep and Performance Research Center, Washington State University, PO Box 1495, Spokane, WA 99210-1495, USA; Elson S. Floyd College of Medicine, Washington State University, PO Box 1495, Spokane, WA 99210-1495, USA. Electronic address: layton@wsu.edu.'}, {'ForeName': 'Hans P A', 'Initials': 'HPA', 'LastName': 'Van Dongen', 'Affiliation': 'Sleep and Performance Research Center, Washington State University, PO Box 1495, Spokane, WA 99210-1495, USA; Elson S. Floyd College of Medicine, Washington State University, PO Box 1495, Spokane, WA 99210-1495, USA. Electronic address: hvd@wsu.edu.'}]",Physiology & behavior,['10.1016/j.physbeh.2019.112643']
1039,32140973,"Sense of coherence and its relationship to participation, cancer-related fatigue, symptom burden, and quality of life in women with breast cancer participating in the OptiTrain exercise trial.","PURPOSE


This study examined the Sense of Coherence (SOC) of patients participating in the randomized controlled 'Optimal Training for Women with Breast Cancer' (OptiTrain) study and assessed how patient characteristics were associated with SOC. Secondary aims were to assess the association between SOC and patients' participation in this study and to determine whether SOC moderates the effect of the 16-week exercise intervention on fatigue, quality of life (QoL), and symptom burden in women with breast cancer undergoing chemotherapy.
METHODS


Modified Poisson regression analyses were conducted to determine the relative risk of weak-normal SOC versus strong SOC in terms of exercise session attendance, study and intervention dropout, and long absence rates. Analyses of covariance were performed to assess whether SOC moderated the effect of the exercise intervention (p interaction  ≤ 0.10).
RESULTS


Two hundred and forty women with early breast cancer (mean age 53 ± 10) participated in the OptiTrain study. Women with strong SOC reported less fatigue, lower symptom burden, and higher QoL. Women with weak-normal SOC were significantly more likely to drop out from the OptiTrain study and tended to have slightly poorer exercise session attendance. Women with breast cancer and weaker SOC benefitted as much from the exercise intervention, in terms of fatigue and QoL, as those with stronger SOC (p interaction  > 0.10).
CONCLUSIONS


Strong SOC appears to be associated with a more positive subjective state of health. Women with weak-normal SOC may need additional support to encourage participation and adherence in exercise trials. Assessing SOC may assist clinicians to identify and provide extra support for participants with weak SOC, who may be less inclined to participate in exercise programs.",2020,"Women with breast cancer and weaker SOC benefitted as much from the exercise intervention, in terms of fatigue and QoL, as those with stronger SOC (p interaction  > 0.10).
","['women with breast cancer undergoing chemotherapy', 'Women with weak-normal SOC', 'Women with breast cancer and weaker SOC', 'women with breast cancer participating in the OptiTrain exercise trial', 'Two hundred and forty women with early breast cancer (mean age 53\u2009±\u200910) participated in the OptiTrain study', ""patients participating in the randomized controlled 'Optimal Training for Women with Breast Cancer' (OptiTrain"", 'participants with weak SOC']",['exercise intervention'],"['participation, cancer-related fatigue, symptom burden, and quality of life', 'fatigue, quality of life (QoL), and symptom burden']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1762617', 'cui_str': 'Weak (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C4274302', 'cui_str': 'Fatigue associated with malignant neoplastic disease'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034380'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",240.0,0.059464,"Women with breast cancer and weaker SOC benefitted as much from the exercise intervention, in terms of fatigue and QoL, as those with stronger SOC (p interaction  > 0.10).
","[{'ForeName': 'Anouk E', 'Initials': 'AE', 'LastName': 'Hiensch', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands. a.e.hiensch-2@umcutrecht.nl.'}, {'ForeName': 'Kate A', 'Initials': 'KA', 'LastName': 'Bolam', 'Affiliation': 'Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Mijwel', 'Affiliation': 'Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'May', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Wengström', 'Affiliation': 'Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-020-05378-0']
1040,32139400,Cluster randomised controlled trial evaluating the clinical and humanistic impact of a pharmacist-led minor ailment service.,"BACKGROUND


Community pharmacists are well positioned to support patients' minor ailments. The objective was to evaluate the clinical and humanistic impact of a minor ailment service (MAS) in community pharmacy compared with usual pharmacist care (UC).
METHODS


A cluster randomised controlled trial was conducted. Intervention patients received MAS, which included a consultation with the pharmacist. MAS pharmacists were trained in clinical pathways and communication systems mutually agreed with general practitioners and received monthly support. Control patients received UC. All patients were followed up by telephone at 14 days. Clinical and humanistic impact were defined by primary (appropriate referral rate and appropriate non-prescription medicine rate) and secondary outcomes (clinical product-based intervention rate, referral adherence, symptom resolution, reconsultation and EuroQol EQ-5D visual analogue scale (VAS)).
RESULTS


Patients (n=894) were recruited from 30 pharmacies and 82% (n=732) responded to follow-up. Patients receiving MAS were 1.5 times more likely to receive an appropriate referral (relative rate (RR)=1.51; 95% CI 1.07 to 2.11; p=0.018) and were five times more likely to adhere to referral, compared with UC (RR=5.08; 95%CI 2.02 to 12.79; p=0.001). MAS patients (94%) achieved symptom resolution or relief at follow-up, while this was 88% with UC (RR=1.06; 95% CI 1 to 1.13; p=0.035). MAS pharmacists were 1.2 times more likely to recommend an appropriate medicine (RR 1.20, 95% CI 1.1 to 1.3; p=0.000) and were 2.6 times more likely to perform a clinical product-based intervention (RR=2.62, 95% CI 1.28 to 5.38; p=0.009), compared with UC. MAS patients had a greater mean difference in VAS at follow-up (4.08; 95% CI 1.23 to 6.87; p=0.004). No difference in reconsultation was observed (RR=0.98; 95% CI 0.75 to 1.28; p=0.89).
CONCLUSION


The study demonstrates improved clinical and humanistic outcomes with MAS. National implementation is a means to manage minor ailments more effectively in the Australian health system.
TRIAL REGISTRATION NUMBER


ACTRN12618000286246.",2020,"No difference in reconsultation was observed (RR=0.98; 95% CI 0.75 to 1.28; p=0.89).
",['Patients (n=894) were recruited from 30 pharmacies and 82% (n=732) responded to follow-up'],"['MAS', 'minor ailment service (MAS', 'UC', 'usual pharmacist care (UC', 'pharmacist-led minor ailment service']","['symptom resolution or relief', 'secondary outcomes (clinical product-based intervention rate, referral adherence, symptom resolution, reconsultation and EuroQol EQ-5D visual analogue scale (VAS', 'reconsultation', 'VAS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0031322', 'cui_str': 'Pharmacies'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0023175', 'cui_str': 'Lead'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1301676', 'cui_str': 'Relieves (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0360301', 'cui_str': 'Product base (product)'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",894.0,0.213097,"No difference in reconsultation was observed (RR=0.98; 95% CI 0.75 to 1.28; p=0.89).
","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Dineen-Griffin', 'Affiliation': 'Graduate School of Health, University of Technology Sydney, Ultimo, New South Wales, Australia sarah.dineen-griffin@uts.edu.au.'}, {'ForeName': 'Shalom I', 'Initials': 'SI', 'LastName': 'Benrimoj', 'Affiliation': 'Graduate School of Health, University of Technology Sydney, Ultimo, New South Wales, Australia.'}, {'ForeName': 'Kris', 'Initials': 'K', 'LastName': 'Rogers', 'Affiliation': 'Graduate School of Health, University of Technology Sydney, Ultimo, New South Wales, Australia.'}, {'ForeName': 'Kylie A', 'Initials': 'KA', 'LastName': 'Williams', 'Affiliation': 'Graduate School of Health, University of Technology Sydney, Ultimo, New South Wales, Australia.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Garcia-Cardenas', 'Affiliation': 'Graduate School of Health, University of Technology Sydney, Ultimo, New South Wales, Australia.'}]",BMJ quality & safety,['10.1136/bmjqs-2019-010608']
1041,32507989,[Timing of androgen-deprivation therapy and radical radiotherapy in localized prostate cancer: a phase III randomized controlled trial].,,2020,,['localized prostate cancer'],['androgen-deprivation therapy and radical radiotherapy'],[],"[{'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}]","[{'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]",[],,0.0915835,,"[{'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Nieder', 'Affiliation': 'Dept. of Oncology and Palliative Medicine, Nordland Hospital Trust, P.O. Box 1480, 8092, Bodø, Norwegen. carsten.nieder@nlsh.no.'}]",Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al],['10.1007/s00066-020-01645-5']
1042,31977270,D-Index-Guided Early Antifungal Therapy Versus Empiric Antifungal Therapy for Persistent Febrile Neutropenia: A Randomized Controlled Noninferiority Trial.,"PURPOSE


Empiric antifungal therapy (EAT) is recommended for persistent febrile neutropenia (FN), but in most patients, it is associated with overtreatment. The D-index, calculated as the area surrounded by the neutrophil curve and the horizontal line at a neutrophil count of 500/μL, reflects both the duration and depth of neutropenia and enables real-time monitoring of the risk of invasive fungal infection in individual patients at no cost. We investigated a novel approach for patients with persistent FN called D-index-guided early antifungal therapy (DET), in which antifungal treatment is postponed until a D-index reaches 5,500 or the detection of positive serum or imaging tests, and compared it with EAT in this multicenter open-label noninferiority randomized controlled trial.
PATIENTS AND METHODS


We randomly assigned 423 patients who underwent chemotherapy or hematopoietic stem-cell transplantation for hematologic malignancies to the EAT or DET group. The prophylactic use of antifungal agents other than polyenes, echinocandins, or voriconazole was allowed. Micafungin at 150 mg per day was administered as EAT or DET.
RESULTS


In an intent-to-treat analysis of 413 patients, the incidence of probable/proven invasive fungal infection was 2.5% in the EAT group and 0.5% in the DET group, which fulfilled the predetermined criterion of noninferiority of the DET group (-2.0%; 90% CI, -4.0% to 0.1%). The survival rate was 98.0% versus 98.6% at day 42 and 96.4% versus 96.2% at day 84. The use of micafungin was significantly reduced in the DET group (60.2%  v  32.5%;  P  < .001).
CONCLUSION


A novel strategy, DET, decreased the use and cost of antifungal agents without increasing invasive fungal infections and can be a reasonable alternative to empiric or preemptive antifungal therapy.",2020,"The use of micafungin was significantly reduced in the DET group (60.2%  v  32.5%;  P  < .001).
","['Persistent Febrile Neutropenia', 'patients with persistent FN called D-index-guided early antifungal therapy (DET', 'We randomly assigned 423 patients who underwent chemotherapy or hematopoietic stem-cell transplantation for hematologic malignancies to the EAT or DET group']","['Micafungin', 'Empiric antifungal therapy (EAT', 'D-Index-Guided Early Antifungal Therapy Versus Empiric Antifungal Therapy']","['incidence of probable/proven invasive fungal infection', 'survival rate']","[{'cui': 'C0746883', 'cui_str': 'Febrile Neutropenia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0678026', 'cui_str': 'Antifungal therapy (procedure)'}, {'cui': 'C0027170', 'cui_str': 'N,-N-diethyltryptamine (substance)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0472699', 'cui_str': 'Hematopoietic Stem Cell Transplantation'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0376545', 'cui_str': 'Hematological Neoplasms'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C1120386', 'cui_str': 'micafungin'}, {'cui': 'C0678026', 'cui_str': 'Antifungal therapy (procedure)'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C1262313', 'cui_str': 'Invasive Mycoses'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",423.0,0.0720768,"The use of micafungin was significantly reduced in the DET group (60.2%  v  32.5%;  P  < .001).
","[{'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Kanda', 'Affiliation': 'Division of Hematology, Jichi Medical University Saitama Medical Center, Saitama, Japan.'}, {'ForeName': 'Shun-Ichi', 'Initials': 'SI', 'LastName': 'Kimura', 'Affiliation': 'Division of Hematology, Jichi Medical University Saitama Medical Center, Saitama, Japan.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Iino', 'Affiliation': 'Department of Hematology, Yamanashi Prefectural Central Hospital, Kofu, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Fukuda', 'Affiliation': 'Department of Hematopoietic Stem Cell Transplantation, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Emiko', 'Initials': 'E', 'LastName': 'Sakaida', 'Affiliation': 'Department of Hematology, Chiba University Hospital, Chiba, Japan.'}, {'ForeName': 'Tatsuo', 'Initials': 'T', 'LastName': 'Oyake', 'Affiliation': 'Division of Hematology and Oncology, Department of Internal Medicine, Iwate Medical University School of Medicine, Morioka, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Yamaguchi', 'Affiliation': 'Department of Hematology, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Shin-Ichiro', 'Initials': 'SI', 'LastName': 'Fujiwara', 'Affiliation': 'Division of Hematology, Department of Medicine, Jichi Medical University, Saitama, Japan.'}, {'ForeName': 'Yumi', 'Initials': 'Y', 'LastName': 'Jo', 'Affiliation': 'Infection Control Division, Department of Oncology and Hematology, Shimane University Hospital, Izumo, Japan.'}, {'ForeName': 'Akinao', 'Initials': 'A', 'LastName': 'Okamoto', 'Affiliation': 'Department of Hematology, Fujita Health University School of Medicine, Toyoake, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Fujita', 'Affiliation': 'Department of Hematology, Saiseikai Yokohama Nanbu Hospital, Yokohama, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Takamatsu', 'Affiliation': 'Division of Medical Oncology, Hematology and Infectious Diseases, Department of Internal Medicine, Fukuoka University Hospital, Fukuoka, Japan.'}, {'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Saburi', 'Affiliation': 'Department of Hematology, Oita Prefectural Hospital, Oita, Japan.'}, {'ForeName': 'Itaru', 'Initials': 'I', 'LastName': 'Matsumura', 'Affiliation': 'Department of Hematology and Rheumatology, Kindai University Faculty of Medicine, Osaka, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Yamanouchi', 'Affiliation': 'Department of Hematology, Clinical Immunology and Infectious Diseases, Ehime University Graduate School of Medicine, Matsuyama, Japan.'}, {'ForeName': 'Souichi', 'Initials': 'S', 'LastName': 'Shiratori', 'Affiliation': 'Department of Hematology, Hokkaido University Faculty of Medicine, Sapporo, Japan.'}, {'ForeName': 'Moritaka', 'Initials': 'M', 'LastName': 'Gotoh', 'Affiliation': 'Department of Hematology, Tokyo Medical University, Tokyo, Japan.'}, {'ForeName': 'Shingen', 'Initials': 'S', 'LastName': 'Nakamura', 'Affiliation': 'Department of Hematology, Endocrinology and Metabolism, Institute of Biomedical Sciences, Tokushima University Graduate School, Tokushima, Japan.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Tamura', 'Affiliation': 'General Medical Research Center, Fukuoka University, Fukuoka, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.01916']
1043,32508297,Effects of synbiotic supplementation on metabolic parameters and apelin in women with polycystic ovary syndrome: a randomised double-blind placebo-controlled trial - Corrigendum.,,2020,,['women with polycystic ovary syndrome'],"['synbiotic supplementation', 'placebo']",['metabolic parameters and apelin'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}]","[{'cui': 'C2936470', 'cui_str': 'Synbiotics'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C3542402', 'cui_str': 'Apelin'}]",,0.796448,,"[{'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Karimi', 'Affiliation': ''}, {'ForeName': 'Ashraf', 'Initials': 'A', 'LastName': 'Moini', 'Affiliation': ''}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Yaseri', 'Affiliation': ''}, {'ForeName': 'Nooshin', 'Initials': 'N', 'LastName': 'Shirzad', 'Affiliation': ''}, {'ForeName': 'Mahdi', 'Initials': 'M', 'LastName': 'Sepidarkish', 'Affiliation': ''}, {'ForeName': 'Mojgan', 'Initials': 'M', 'LastName': 'Hossein-Boroujerdi', 'Affiliation': ''}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Javad Hosseinzadeh-Attar', 'Affiliation': ''}]",The British journal of nutrition,['10.1017/S0007114520001488']
1044,32502923,"A phase III, randomized, double-blind, multicenter study to compare the efficacy, safety, pharmacokinetics, and immunogenicity between SB8 (proposed bevacizumab biosimilar) and reference bevacizumab in patients with metastatic or recurrent nonsquamous non-small cell lung cancer.","OBJECTIVES


Efficacy, safety, pharmacokinetics (PK), and immunogenicity of the biosimilar candidate SB8 was compared to its reference product bevacizumab (BEV) in patients with metastatic or recurrent nonsquamous non-small cell lung cancer.
METHODS


Patients were randomized (1:1) in a phase III, double-blind study to receive intravenous SB8 or BEV 15 mg/kg with paclitaxel/carboplatin every 3 weeks for 24 weeks, followed by SB8 or BEV maintenance monotherapy. The primary endpoint was best overall response rate (ORR) by 24 weeks. Secondary endpoints included survival outcomes, safety, PK, and immunogenicity.
RESULTS


763 patients (SB8, n = 379; BEV, n = 384) were randomized; baseline characteristics were well balanced. Best ORR in the FAS was 47.6% and 42.8%, and best ORR in the PPS was 50.1% and 44.8% for SB8 and BEV, respectively. The risk ratio of best ORR was 1.11 (90% CI, 0.975-1.269), and the risk difference in best ORR was 5.3% (95% CI, -2.2%-12.9%). Median survival outcomes were comparable between SB8 and BEV: progression-free survival was 8.50 vs 7.90 months, respectively (HR [95% CI], 0.99 [0.83-1.18]; p = 0.9338); overall survival was 14.90 vs 15.80 months, respectively (HR [95% CI], 1.03 [0.83-1.28]; p = 0.7713); and duration of response was 7.70 vs 7.00 months, respectively (HR [95% CI], 1.05 [0.81-1.37]; p = 0.6928). Severity and incidence of treatment-emergent adverse events, PK, and immunogenicity were comparable between SB8 and BEV.
CONCLUSION


This study demonstrated equivalence between SB8 and BEV in terms of best ORR risk ratio, with comparable safety, PK, and immunogenicity.",2020,"Severity and incidence of treatment-emergent adverse events, PK, and immunogenicity were comparable between SB8 and BEV.
","['763 patients (SB8, n\u2009=\u2009379; BEV, n\u2009=\u2009384', 'Patients', 'patients with metastatic or recurrent nonsquamous non-small cell lung cancer']","['paclitaxel/carboplatin', 'bevacizumab (BEV', 'bevacizumab', 'intravenous SB8 or BEV 15']","['duration of response', 'Efficacy, safety, pharmacokinetics (PK), and immunogenicity', 'risk ratio of best ORR', 'Median survival outcomes', 'safety, PK, and immunogenicity', 'overall response rate (ORR', 'overall survival', 'Severity and incidence of treatment-emergent adverse events, PK, and immunogenicity', 'FAS', 'efficacy, safety, pharmacokinetics, and immunogenicity', 'SB8 and BEV: progression-free survival', 'survival outcomes, safety, PK, and immunogenicity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}]","[{'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",763.0,0.560036,"Severity and incidence of treatment-emergent adverse events, PK, and immunogenicity were comparable between SB8 and BEV.
","[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Reck', 'Affiliation': 'Department of Thoracic Oncology, Lung Clinic Grosshansdorf, Airway Research Center North, German Center of Lung Research, Lung Clinic, Woehrendamm 80, 22927 Grosshansdorf, Germany. Electronic address: m.reck@lungenclinic.de.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Luft', 'Affiliation': 'Department of Thoracic Surgery, Leningrad Regional Clinical Hospital, St. Petersburg, Russian Federation. Electronic address: alexander_luft@mail.ru.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Bondarenko', 'Affiliation': 'Oncology and Medical Radiology Department, Dnipropetrovsk Medical Academy, Dnipro, Ukraine. Electronic address: oncology@dsma.dp.ua.'}, {'ForeName': 'Serhii', 'Initials': 'S', 'LastName': 'Shevnia', 'Affiliation': 'Department of Chemotherapy, Podillia Regional Oncology Center, Vinnytsia, Ukraine. Electronic address: shevnia1969@gmail.com.'}, {'ForeName': 'Dmytro', 'Initials': 'D', 'LastName': 'Trukhin', 'Affiliation': 'Oncology Department, Odessa Regional Oncology Center, Odessa, Ukraine. Electronic address: dtrukhin39@gmail.com.'}, {'ForeName': 'Nadezhda V', 'Initials': 'NV', 'LastName': 'Kovalenko', 'Affiliation': 'Oncology, Volgograd Regional Clinical Oncology Dispensary, Volgograd, Russian Federation. Electronic address: kovalenkost@yandex.ru.'}, {'ForeName': 'Kakha', 'Initials': 'K', 'LastName': 'Vacharadze', 'Affiliation': 'Department of Phthisiatry, Research Institute of Clinical Medicine, Tbilisi, Georgia. Electronic address: kakhavacharadze@yahoo.com.'}, {'ForeName': 'Fülöp', 'Initials': 'F', 'LastName': 'Andrea', 'Affiliation': 'Department of Pulmonary Class and Bronchology, Országos Korányi TBC és Pulmonológiai Intézet, Budapest, Hungary. Electronic address: afulop64@gmail.com.'}, {'ForeName': 'Anatoliy', 'Initials': 'A', 'LastName': 'Hontsa', 'Affiliation': 'Day Staing Department, Chernivtsi Regional Oncology Center, Chernivtsi, Ukraine. Electronic address: anatoliyhontsa@gmail.com.'}, {'ForeName': 'Jihye', 'Initials': 'J', 'LastName': 'Choi', 'Affiliation': 'Biometrics, Samsung Bioepis Co., Ltd., Suwon, Republic of Korea. Electronic address: jihye24.choi@samsung.com.'}, {'ForeName': 'Donghoon', 'Initials': 'D', 'LastName': 'Shin', 'Affiliation': 'Clinical Development, Samsung Bioepis Co., Ltd., Suwon, Republic of Korea. Electronic address: dh01.shin@samsung.com.'}]","Lung cancer (Amsterdam, Netherlands)",['10.1016/j.lungcan.2020.05.027']
1045,32493780,Accuracy of Xpert Ultra in Diagnosis of Pulmonary Tuberculosis among Children in Uganda: a Substudy from the SHINE Trial.,"Childhood tuberculosis (TB) presents significant diagnostic challenges associated with paucibacillary disease and requires a more sensitive test. We evaluated the diagnostic accuracy of Xpert MTB/RIF Ultra (Ultra) compared to other microbiological tests using respiratory samples from Ugandan children in the SHINE trial. SHINE is a randomized trial evaluating shorter treatment in 1,204 children with minimal TB disease in Africa and India. Among 352 samples and one cervical lymph node fine needle aspirate, one sample was randomly selected per patient and tested with the Xpert MTB/RIF assay (Xpert) and with Lowenstein-Jensen medium (LJ) and liquid mycobacterial growth indicator tube (MGIT) cultures. We selected only uncontaminated stored sample pellets for Ultra testing. We estimated the sensitivity of Xpert and Ultra against culture and a composite microbiological reference standard (any positive result). Of 398 children, 353 (89%) had culture, Xpert, and Ultra results. The median age was 2.8 years (interquartile range [IQR], 1.3 to 5.3); 8.5% (30/353) were HIV infected, and 54.4% (192/353) were male. Of the 353, 31 (9%) were positive by LJ and/or MGIT culture, 36 (10%) by Ultra, and 16 (5%) by Xpert. Sensitivities (95% confidence intervals [CI]) were 58% (39 to 65% [18/31]) for Ultra and 45% (27 to 64% [14/31]) for Xpert against any culture-positive result, with false positives of <1% and 5.5% for Xpert and Ultra. Against a composite microbiological reference, sensitivities were 72% (58 to 84% [36/50]) for Ultra and 32% (20 to 47% [16/50]) for Xpert. However, there were 17 samples that were positive only with Ultra (majority trace). Among children screened for minimal TB in Uganda, Ultra has higher sensitivity than Xpert. This represents an important advance for a condition which has posed a diagnostic challenge for decades.",2020,"Sensitivities were (%; 95% CI), 58% (39-65% (18/31)) for Ultra and 45% (27-64% (14/31)) for Xpert against any culture-positive, with false-positives of <1% and 5.5% for Xpert and Ultra.","['Ugandan children in the SHINE trial', '1204 children with minimal TB disease in Africa/India', '398 children, 353 (89%) had culture, Xpert and Ultra results', 'Among 352 samples and one cervical lymph node fine needle aspirate, one sample was randomly selected per patient and tested with', 'Median age was 2.8-years (IQR 1.3-5.3); 8.5% (30/353) HIV-infected, 54.4% (192/353) male', 'pulmonary tuberculosis among children in Uganda']","['Xpert MTB/Rif (Xpert), Lowenstein Jensen (LJ) and liquid (MGIT) cultures', 'XpertMTB/Rif Ultra (Ultra', 'Xpert Ultra']",['Sensitivities'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0001737', 'cui_str': 'Africa'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0588054', 'cui_str': 'Cervical lymph node group'}, {'cui': 'C1280568', 'cui_str': 'Specimen obtained by fine needle aspiration procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517499', 'cui_str': '1.3'}, {'cui': 'C4708663', 'cui_str': '5.3'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0041327', 'cui_str': 'Pulmonary tuberculosis'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}]","[{'cui': 'C0026926', 'cui_str': 'Mycobacterium tuberculosis'}, {'cui': 'C0035608', 'cui_str': 'Rifampin'}, {'cui': 'C3665438', 'cui_str': 'Juxtapapillary focal retinitis AND retinochoroiditis'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C0010453', 'cui_str': 'Culture'}]","[{'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]",1204.0,0.137987,"Sensitivities were (%; 95% CI), 58% (39-65% (18/31)) for Ultra and 45% (27-64% (14/31)) for Xpert against any culture-positive, with false-positives of <1% and 5.5% for Xpert and Ultra.","[{'ForeName': 'Willy', 'Initials': 'W', 'LastName': 'Ssengooba', 'Affiliation': 'Makerere University, Department of Medical Microbiology, Mycobacteriology (BSL-3) Laboratory, Kampala, Uganda Willyssengooba@gmail.com.'}, {'ForeName': 'Jean de Dieu', 'Initials': 'JD', 'LastName': 'Iragena', 'Affiliation': 'Communicable Diseases Cluster, HIV/TB and Hepatitis Programme, World Health Organization Regional Office for Africa, Brazzaville, Congo.'}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Nakiyingi', 'Affiliation': 'Infectious Diseases Institute, College of Health Sciences Makerere University, Kampala, Uganda.'}, {'ForeName': 'Serestine', 'Initials': 'S', 'LastName': 'Mujumbi', 'Affiliation': 'Makerere University, Department of Medical Microbiology, Mycobacteriology (BSL-3) Laboratory, Kampala, Uganda.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Wobudeya', 'Affiliation': 'Makerere University-Johns Hopkins University Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Mboizi', 'Affiliation': 'Makerere University-Johns Hopkins University Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Boulware', 'Affiliation': 'Infectious Diseases Institute, College of Health Sciences Makerere University, Kampala, Uganda.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Meya', 'Affiliation': 'Infectious Diseases Institute, College of Health Sciences Makerere University, Kampala, Uganda.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Choo', 'Affiliation': 'MRC Clinical Trials Unit, University College London, London, United Kingdom.'}, {'ForeName': 'Angela M', 'Initials': 'AM', 'LastName': 'Crook', 'Affiliation': 'MRC Clinical Trials Unit, University College London, London, United Kingdom.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Lebeau', 'Affiliation': 'MRC Clinical Trials Unit, University College London, London, United Kingdom.'}, {'ForeName': 'Moses', 'Initials': 'M', 'LastName': 'Joloba', 'Affiliation': 'Makerere University, Department of Medical Microbiology, Mycobacteriology (BSL-3) Laboratory, Kampala, Uganda.'}, {'ForeName': 'Anne-Marie', 'Initials': 'AM', 'LastName': 'Demers', 'Affiliation': 'Desmond Tutu Tuberculosis Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa.'}, {'ForeName': 'Fiona V', 'Initials': 'FV', 'LastName': 'Cresswell', 'Affiliation': 'Makerere University-Johns Hopkins University Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Diana M', 'Initials': 'DM', 'LastName': 'Gibb', 'Affiliation': 'MRC Clinical Trials Unit, University College London, London, United Kingdom.'}]",Journal of clinical microbiology,['10.1128/JCM.00410-20']
1046,32496865,Socioecological determinants of community resource utilisation among low-income women in Mexico City who experienced male-to-female intimate partner violence.,"Women who experience intimate partner violence (IPV) face multiple barriers to seeking help from community resources, but little research has examined the impact of ecological influences on community resource utilisation among women living in low- and middle-income countries. The current study investigated individual-, relationship-, family-, and community-level influences on community resource utilisation among Mexican women experiencing IPV. Using baseline data from 950 women in Mexico City enrolled in a clinic-based randomised controlled trial, multilevel regressions were performed to assess associations between socioecological factors and women's community resource utilisation. 41.3% women used at least one resource. At the individual-level, every additional resource that women were aware of, was associated with a 20% increase in the total number of resources used ( p  < .001). Every additional lethal risk factor was associated with a 5% increase in the total number of resources used ( p  = .004). At the family-level, women who reported having an in-law encourage IPV used 46% more resources ( p  < .001). At the community-level, stronger supportive norms around community resource utilisation was associated with a 6% increase in the total number of resources ( p  = .01). These findings suggest the importance of addressing family and community factors in the broader ecological context of Mexican women's help-seeking behaviours.",2020,Every additional lethal risk factor was associated with a 5% increase in the total number of resources used ( p  = .004).,"['low-income women in Mexico City who experienced male-to-female intimate partner violence', 'Mexican women experiencing IPV', 'Women who experience intimate partner violence (IPV', '950 women in Mexico City enrolled in a clinic', 'women living in low- and middle-income countries']",[],"['total number of resources', 'total number of resources used']","[{'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025885', 'cui_str': 'Mexico'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C4708800', 'cui_str': '950'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0454664', 'cui_str': 'Country'}]",[],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0035201', 'cui_str': 'Resources'}]",950.0,0.0384717,Every additional lethal risk factor was associated with a 5% increase in the total number of resources used ( p  = .004).,"[{'ForeName': 'Tiara C', 'Initials': 'TC', 'LastName': 'Willie', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Bastida', 'Affiliation': 'Department of Psychiatry, University of California, Davis, CA, USA.'}, {'ForeName': 'Claudia Diaz', 'Initials': 'CD', 'LastName': 'Olavarrieta', 'Affiliation': 'Research Division, Faculty of Medicine, National Autonomous University of Mexico, Mexico City, Mexico.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Scolese', 'Affiliation': 'Department of Global and Community Health, George Mason University, Fairfax, VA, USA.'}, {'ForeName': 'Paola Abril', 'Initials': 'PA', 'LastName': 'Campos', 'Affiliation': 'Harvard TH Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Kathryn L', 'Initials': 'KL', 'LastName': 'Falb', 'Affiliation': 'International Rescue Committee, Washington, DC, USA.'}, {'ForeName': 'Jhumka', 'Initials': 'J', 'LastName': 'Gupta', 'Affiliation': 'Department of Global and Community Health, George Mason University, Fairfax, VA, USA.'}]",Global public health,['10.1080/17441692.2020.1775868']
1047,31558733,Oxytocin modulates the temporal dynamics of resting EEG networks.,"Oxytocin is a key modulator of social interaction, but we possess little knowledge of its underlying effects on neuropsychological processes. We used a spatio-temporal EEG microstates analysis to reveal oxytocin's effects on the temporal dynamics of intrinsically generated activity in neural networks. Given oxytocin's known anxiolytic effects, we hypothesized that it increases the temporal stability of the four archetypal EEG resting networks. Eighty-six male participants had received oxytocin or placebo intranasally before we recorded their resting EEG. As hypothesized, oxytocin globally increased the average duration of the four archetypal resting networks and specifically decreased the occurrence and coverage of an autonomic processing-related network to benefit greater coverage of an attention-related network. Moreover, these neurophysiological changes were more pronounced in participants with high anxiety levels and strong subjectively experienced effects of the oxytocin administration. In sum, our study shows that oxytocin reduces rapid switching among neural resting networks by increasing their temporal stability. Specifically, it seems to reduce the brain's need for preparing the internally-oriented processing of autonomic information, thus enabling the externally-oriented processing of social information. Changes in the temporal dynamics of resting networks might underlie oxytocin's anxiolytic effects - potentially informing innovative psychobiological treatment strategies.",2019,"As hypothesized, oxytocin globally increased the average duration of the four archetypal resting networks and specifically decreased the occurrence and coverage of an autonomic processing-related network to benefit greater coverage of an attention-related network.",['Eighty-six male participants'],"['oxytocin', 'Oxytocin', 'oxytocin or placebo']",[],"[{'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]",[],86.0,0.0817619,"As hypothesized, oxytocin globally increased the average duration of the four archetypal resting networks and specifically decreased the occurrence and coverage of an autonomic processing-related network to benefit greater coverage of an attention-related network.","[{'ForeName': 'Bastian', 'Initials': 'B', 'LastName': 'Schiller', 'Affiliation': 'Department of Psychology, Laboratory for Biological and Personality Psychology, University of Freiburg, DE-79104, Freiburg, Germany. schiller@psychologie.uni-freiburg.de.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Koenig', 'Affiliation': 'Translational Research Center, University Hospital of Psychiatry, University of Bern, CH-3000, Bern, Switzerland.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Heinrichs', 'Affiliation': 'Department of Psychology, Laboratory for Biological and Personality Psychology, University of Freiburg, DE-79104, Freiburg, Germany. heinrichs@psychologie.uni-freiburg.de.'}]",Scientific reports,['10.1038/s41598-019-49636-6']
1048,31070807,Bayesian hierarchical EMAX model for dose-response in early phase efficacy clinical trials.,"A primary goal of a phase II dose-ranging trial is to identify a correct dose before moving forward to a phase III confirmatory trial. A correct dose is one that is actually better than control. A popular model in phase II is an independent model that puts no structure on the dose-response relationship. Unfortunately, the independent model does not efficiently use information from related doses. One very successful alternate model improves power using a pre-specified dose-response structure. Past research indicates that EMAX models are broadly successful and therefore attractive for designing dose-response trials. However, there may be instances of slight risk of nonmonotone trends that need to be addressed when planning a clinical trial design. We propose to add hierarchical parameters to the EMAX model. The added layer allows information about the treatment effect in one dose to be ""borrowed"" when estimating the treatment effect in another dose. This is referred to as the hierarchical EMAX model. Our paper compares three different models (independent, EMAX, and hierarchical EMAX) and two different design strategies. The first design considered is Bayesian with a fixed trial design, and it has a fixed schedule for randomization. The second design is Bayesian but adaptive, and it uses response adaptive randomization. In this article, a randomized trial of patients with severe traumatic brain injury is provided as a motivating example.",2019,"The second design is Bayesian but adaptive, and it uses response adaptive randomization.",['patients with severe traumatic brain injury'],[],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0876926', 'cui_str': 'TBI (Traumatic Brain Injury)'}]",[],[],,0.0235633,"The second design is Bayesian but adaptive, and it uses response adaptive randomization.","[{'ForeName': 'Byron J', 'Initials': 'BJ', 'LastName': 'Gajewski', 'Affiliation': 'Department of Biostatistics & Data Science, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Caitlyn', 'Initials': 'C', 'LastName': 'Meinzer', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': 'Scott M', 'Initials': 'SM', 'LastName': 'Berry', 'Affiliation': 'Department of Biostatistics & Data Science, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Gaylan L', 'Initials': 'GL', 'LastName': 'Rockswold', 'Affiliation': 'Hennepin County Medical Center, Minneapolis, Minnesota.'}, {'ForeName': 'William G', 'Initials': 'WG', 'LastName': 'Barsan', 'Affiliation': 'Department of Emergency Medicine, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Frederick K', 'Initials': 'FK', 'LastName': 'Korley', 'Affiliation': 'Department of Emergency Medicine, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': ""Renee' H"", 'Initials': 'RH', 'LastName': 'Martin', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, South Carolina.'}]",Statistics in medicine,['10.1002/sim.8167']
1049,32153031,Attempting Randomized Housing First Research in a Community Context: Reflections on Failure.,"The Housing First (HF) model of permanent supportive housing for individuals experiencing chronic homelessness has a strong evidence base that has largely been driven by researchers in the field of community psychology in partnership with community-based organizations. However, important gaps in the HF literature remain. Implementing rigorous research designs to further the evidence for HF requires immense resources to fund both the housing intervention and the research activities. In the absence of such resources, university-community partnerships may be established to integrate research within business-as-usual services and utilize existing housing units. This first person account presents a ""post-mortem"" exploration of an attempt to conduct a randomized trial of scattered-site and single-site approaches to HF within a community context from the perspectives of multiple stakeholders involved in the endeavor. Despite strengths of the research collaborative, the project did not come to completion due to a series of both insurmountable and avoidable barriers. Yet, the experience illuminated several potential challenges researchers and housing providers conducting work in this area may encounter, such as ever-changing homeless service system policies that may impact research and organizational procedures. Lessons learned and recommendations for preventing or overcoming systems-level barriers and potential challenges within the university-community partnership are described.",2020,The Housing First (HF) model of permanent supportive housing for individuals experiencing chronic homelessness has a strong evidence base that has largely been driven by researchers in the field of community psychology in partnership with community-based organizations.,['individuals experiencing chronic homelessness'],[],[],"[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0237154', 'cui_str': 'Homelessness'}]",[],[],,0.030349,The Housing First (HF) model of permanent supportive housing for individuals experiencing chronic homelessness has a strong evidence base that has largely been driven by researchers in the field of community psychology in partnership with community-based organizations.,"[{'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Brown', 'Affiliation': 'DePaul University, Chicago, IL, USA.'}, {'ForeName': 'Anh-Dao', 'Initials': 'AD', 'LastName': 'Tran', 'Affiliation': 'DePaul University, Chicago, IL, USA.'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Cummings', 'Affiliation': 'DePaul University, Chicago, IL, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Fay', 'Affiliation': 'Downtown Emergency Service Center, Seattle, WA, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Malone', 'Affiliation': 'Downtown Emergency Service Center, Seattle, WA, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Fyall', 'Affiliation': 'University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Tsemberis', 'Affiliation': 'Pathways Housing First Institute, Los Angeles, CA, USA.'}]",American journal of community psychology,['10.1002/ajcp.12421']
1050,32501276,"Efficacy of Three Low-Intensity, Internet-Based Psychological Interventions for the Treatment of Depression in Primary Care: Randomized Controlled Trial.","BACKGROUND


Primary care is a major access point for the initial treatment of depression, but the management of these patients is far from optimal. The lack of time in primary care is one of the major difficulties for the delivery of evidence-based psychotherapy. During the last decade, research has focused on the development of brief psychotherapy and cost-effective internet-based interventions mostly based on cognitive behavioral therapy (CBT). Very little research has focused on alternative methods of treatment for depression using CBT. Thus, there is a need for research into other therapeutic approaches.
OBJECTIVE


This study aimed to assess the effectiveness of 3 low-intensity, internet-based psychological interventions (healthy lifestyle psychoeducational program [HLP], focused program on positive affect promotion [PAPP], and brief intervention based on mindfulness [MP]) compared with a control condition (improved treatment as usual [iTAU]).
METHODS


A multicenter, 4-arm, parallel randomized controlled trial was conducted between March 2015 and March 2016, with a follow-up of 12 months. In total, 221 adults with mild or moderate major depression were recruited in primary care settings from 3 Spanish regions. Patients were randomly distributed to iTAU (n=57), HLP (n=54), PAPP (n=56), and MP (n=54). All patients received iTAU from their general practitioners. The main outcome was the Spanish version of the Patient Health Questionnaire-9 (PHQ-9) from pretreatment (time 1) to posttreatment (time 2) and up to 6 (time 3) and 12 (time 4) months' follow-up. Secondary outcomes included the visual analog scale of the EuroQol, the Short-Form Health Survey (SF-12), the Positive and Negative Affect Schedule (PANAS), and the Pemberton Happiness Index (PHI). We conducted regression models to estimate outcome differences along study stages.
RESULTS


A moderate decrease was detected in PHQ-9 scores from HLP (β=-3.05; P=.01) and MP (β=-3.00; P=.01) compared with iTAU at posttreatment. There were significant differences between all intervention groups and iTAU in physical SF-12 scores at 6 months after treatment. Regarding well-being, MP and PAPP reported better PHI results than iTAU at 6 months post treatment. PAPP intervention significantly decreased PANAS negative affect scores compared with iTAU 12 months after treatment.
CONCLUSIONS


The low-intensity, internet-based psychological interventions (HLP and MP) for the treatment of depression in primary care are more effective than iTAU at posttreatment. Moreover, all low-intensity psychological interventions are also effective in improving medium- and long-term quality of life. PAPP is effective for improving health-related quality of life, negative affect, and well-being in patients with depression. Nevertheless, it is important to examine possible reasons that could be implicated for PAPP not being effective in reducing depressive symptomatology; in addition, more research is still needed to assess the cost-effectiveness analysis of these interventions.
TRIAL REGISTRATION


ISRCTN Registry ISRCTN82388279; http://www.isrctn.com/ISRCTN82388279.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


RR2-10.1186/s12888-015-0475-0.",2020,"PAPP is effective for improving health-related quality of life, negative affect, and well-being in patients with depression.","['Depression in Primary Care', 'n=56), and MP (n=54', 'March 2015 and March 2016, with a follow-up of 12 months', 'patients with depression', '221 adults with mild or moderate major depression were recruited in primary care settings from 3 Spanish regions']","['HLP', 'Three Low-Intensity, Internet-Based Psychological Interventions', 'PAPP intervention', 'iTAU', 'PAPP', '3 low-intensity, internet-based psychological interventions (healthy lifestyle psychoeducational program [HLP', 'internet-based psychological interventions (HLP and MP']","['physical SF-12 scores', 'Spanish version of the Patient Health Questionnaire-9', 'PHQ-9 scores', 'visual analog scale of the EuroQol, the Short-Form Health Survey (SF-12), the Positive and Negative Affect Schedule (PANAS), and the Pemberton Happiness Index (PHI']","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0270456', 'cui_str': 'Moderate major depression'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C0263420', 'cui_str': 'Hyperkeratosis lenticularis perstans'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0135262', 'cui_str': '1-(2-(4-aminophenyl)ethyl)-4-(3-trifluoromethylphenyl)piperazine'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0582655', 'cui_str': 'Positive and negative affect schedule'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",221.0,0.0776652,"PAPP is effective for improving health-related quality of life, negative affect, and well-being in patients with depression.","[{'ForeName': 'Margalida', 'Initials': 'M', 'LastName': 'Gili', 'Affiliation': ""Institut Universitari d'Investigació en Ciències de la Salut, University of Balearic Islands, Palma de Mallorca, Spain.""}, {'ForeName': 'Adoración', 'Initials': 'A', 'LastName': 'Castro', 'Affiliation': ""Institut Universitari d'Investigació en Ciències de la Salut, University of Balearic Islands, Palma de Mallorca, Spain.""}, {'ForeName': 'Azucena', 'Initials': 'A', 'LastName': 'García-Palacios', 'Affiliation': 'Department of Clinical and Basic Psychology and Biopsychology, Faculty of Health Sciences, Univeristy Jaume I, Castellón, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Garcia-Campayo', 'Affiliation': 'Primary Care Prevention and Health Promotion Research Network, RedIAPP, Madrid, Spain.'}, {'ForeName': 'Fermin', 'Initials': 'F', 'LastName': 'Mayoral-Cleries', 'Affiliation': 'Mental Heath Unit, Hospital Regional of Malaga, Biomedicine Research Institute (IBIMA), Málaga, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Botella', 'Affiliation': 'Department of Clinical and Basic Psychology and Biopsychology, Faculty of Health Sciences, Univeristy Jaume I, Castellón, Spain.'}, {'ForeName': 'Miquel', 'Initials': 'M', 'LastName': 'Roca', 'Affiliation': ""Institut Universitari d'Investigació en Ciències de la Salut, University of Balearic Islands, Palma de Mallorca, Spain.""}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Barceló-Soler', 'Affiliation': 'Aragón Institute for Health Research (IIS Aragon), Zaragoza, Spain.'}, {'ForeName': 'María M', 'Initials': 'MM', 'LastName': 'Hurtado', 'Affiliation': 'Mental Heath Unit, Hospital Regional of Malaga, Biomedicine Research Institute (IBIMA), Málaga, Spain.'}, {'ForeName': 'MªTeresa', 'Initials': 'M', 'LastName': 'Navarro', 'Affiliation': 'Department of Psychology and Sociology, University of Zaragoza, Zaragoza, Spain.'}, {'ForeName': 'Amelia', 'Initials': 'A', 'LastName': 'Villena', 'Affiliation': 'Mental Health Unit of Pozoblaco, Hospital Los Pedroches, Córdoba, Spain.'}, {'ForeName': 'M Ángeles', 'Initials': 'MÁ', 'LastName': 'Pérez-Ara', 'Affiliation': ""Institut Universitari d'Investigació en Ciències de la Salut, University of Balearic Islands, Palma de Mallorca, Spain.""}, {'ForeName': 'Pau', 'Initials': 'P', 'LastName': 'Riera-Serra', 'Affiliation': ""Institut Universitari d'Investigació en Ciències de la Salut, University of Balearic Islands, Palma de Mallorca, Spain.""}, {'ForeName': 'Rosa Mª', 'Initials': 'RM', 'LastName': 'Baños', 'Affiliation': 'Biomedical Research Center Network (CIBER) Physiopathology Obesity and Nutrition (CIBERobn), Carlos III Health Institute, Madrid, Spain.'}]",Journal of medical Internet research,['10.2196/15845']
1051,31836250,Re: TVT Surgery versus Bulkamid Injection for Primary Stress Urinary Incontinence: A Randomized Clinical Trial.,,2020,,['Primary Stress Urinary Incontinence'],['Re: TVT Surgery versus Bulkamid Injection'],[],"[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0042025', 'cui_str': 'Urinary Stress Incontinence'}]","[{'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C2353119', 'cui_str': 'Bulkamid'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]",[],,0.1103,,"[{'ForeName': 'Dmitry Y', 'Initials': 'DY', 'LastName': 'Pushkar', 'Affiliation': 'Moscow State Medical University of Medicine and Dentistry, Moscow, Russian Federation.'}, {'ForeName': 'George R', 'Initials': 'GR', 'LastName': 'Kasyan', 'Affiliation': 'Moscow State Medical University of Medicine and Dentistry, Moscow, Russian Federation. Electronic address: gkasyan@msmsu.ru.'}]",European urology,['10.1016/j.eururo.2019.11.028']
1052,32501127,Injection versus decompression for carpal tunnel syndrome (INDICATE): feasibility trial.,,2020,,['carpal tunnel syndrome (INDICATE'],['Injection versus decompression'],[],"[{'cui': 'C0007286', 'cui_str': 'Carpal tunnel syndrome'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}]","[{'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0011117', 'cui_str': 'Decompression'}]",[],,0.0129928,,"[{'ForeName': 'James T', 'Initials': 'JT', 'LastName': 'Berwin', 'Affiliation': 'Gloucestershire Royal Hospital, Gloucester, UK.'}, {'ForeName': 'Cushla', 'Initials': 'C', 'LastName': 'Cooper', 'Affiliation': 'Nuffield Department of Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Will', 'Initials': 'W', 'LastName': 'Mason', 'Affiliation': 'Gloucestershire Royal Hospital, Gloucester, UK.'}]","The Journal of hand surgery, European volume",['10.1177/1753193420929249']
1053,31397487,Impact of long-term ticagrelor monotherapy following 1-month dual antiplatelet therapy in patients who underwent complex percutaneous coronary intervention: insights from the Global Leaders trial.,"AIMS


To evaluate the impact of an experimental strategy [23-month ticagrelor monotherapy following 1-month dual antiplatelet therapy (DAPT)] vs. a reference regimen (12-month aspirin monotherapy following 12-month DAPT) after complex percutaneous coronary intervention (PCI).
METHODS AND RESULTS


In the present post hoc analysis of the Global Leaders trial, the primary endpoint [composite of all-cause death or new Q-wave myocardial infarction (MI)] at 2 years was assessed in patients with complex PCI, which includes at least one of the following characteristics: multivessel PCI, ≥3 stents implanted, ≥3 lesions treated, bifurcation PCI with ≥2 stents, or total stent length >60 mm. In addition, patient-oriented composite endpoint (POCE) (composite of all-cause death, any stroke, any MI, or any revascularization) and net adverse clinical events (NACE) [composite of POCE or Bleeding Academic Research Consortium (BARC) Type 3 or 5 bleeding] were explored. Among 15 450 patients included in this analysis, 4570 who underwent complex PCI had a higher risk of ischaemic and bleeding events. In patients with complex PCI, the experimental strategy significantly reduced risks of the primary endpoint [hazard ratio (HR): 0.64, 95% confidence interval (CI): 0.48-0.85] and POCE (HR: 0.80, 95% CI: 0.69-0.93), but not in those with non-complex PCI (Pinteraction = 0.015 and 0.017, respectively). The risk of BARC Type 3 or 5 bleeding was comparable (HR: 0.97, 95% CI: 0.67-1.40), resulting in a significant risk reduction in NACE (HR: 0.80, 95% CI: 0.69-0.92; Pinteraction = 0.011).
CONCLUSION


Ticagrelor monotherapy following 1-month DAPT could provide a net clinical benefit for patients with complex PCI. However, in view of the overall neutral results of the trial, these findings of a post hoc analysis should be considered as hypothesis generating.",2019,"The risk of BARC Type 3 or 5 bleeding was comparable (HR: 0.97, 95% CI: 0.67-1.40), resulting in a significant risk reduction in NACE (HR: 0.80, 95% CI: 0.69-0.92; Pinteraction = 0.011).
","['patients with complex PCI', 'patients who underwent complex percutaneous coronary intervention', '12-month DAPT) after complex percutaneous coronary intervention (PCI', '15\xa0450 patients included in this analysis, 4570 who underwent']","['ticagrelor monotherapy', 'complex PCI', 'antiplatelet therapy (DAPT', 'long-term ticagrelor monotherapy', 'Ticagrelor monotherapy']","['risk of BARC Type 3 or 5 bleeding', 'cause death or new Q-wave myocardial infarction (MI', 'risk of ischaemic and bleeding events', 'patient-oriented composite endpoint (POCE) (composite of all-cause death, any stroke, any MI, or any revascularization) and net adverse clinical events (NACE) [composite of POCE or Bleeding Academic Research Consortium (BARC) Type 3 or 5 bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C3844104', 'cui_str': 'Four hundred and fifty'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0441731', 'cui_str': 'Type 3 (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1305738', 'cui_str': 'Q wave feature'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0035168'}]",,0.265148,"The risk of BARC Type 3 or 5 bleeding was comparable (HR: 0.97, 95% CI: 0.67-1.40), resulting in a significant risk reduction in NACE (HR: 0.80, 95% CI: 0.69-0.92; Pinteraction = 0.011).
","[{'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, Guy Scadding Building, Dovehouse St, Chelsea, London, UK.'}, {'ForeName': 'Kuniaki', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'Department of Cardiology, Academic Medical Center, University of Amsterdam, Meibergdreef 9, AZ, Amsterdam, The Netherlands.'}, {'ForeName': 'Ply', 'Initials': 'P', 'LastName': 'Chichareon', 'Affiliation': 'Department of Cardiology, Academic Medical Center, University of Amsterdam, Meibergdreef 9, AZ, Amsterdam, The Netherlands.'}, {'ForeName': 'Norihiro', 'Initials': 'N', 'LastName': 'Kogame', 'Affiliation': 'Department of Cardiology, Academic Medical Center, University of Amsterdam, Meibergdreef 9, AZ, Amsterdam, The Netherlands.'}, {'ForeName': 'Mariusz', 'Initials': 'M', 'LastName': 'Tomaniak', 'Affiliation': 'Department of Cardiology, Erasmus Medical University Center, Thorax Centre, Molewaterplein 40, GD Rotterdam, The Netherlands.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Modolo', 'Affiliation': 'Department of Cardiology, Academic Medical Center, University of Amsterdam, Meibergdreef 9, AZ, Amsterdam, The Netherlands.'}, {'ForeName': 'Chun Chin', 'Initials': 'CC', 'LastName': 'Chang', 'Affiliation': 'Department of Cardiology, Erasmus Medical University Center, Thorax Centre, Molewaterplein 40, GD Rotterdam, The Netherlands.'}, {'ForeName': 'Hidenori', 'Initials': 'H', 'LastName': 'Komiyama', 'Affiliation': 'Department of Cardiology, Academic Medical Center, University of Amsterdam, Meibergdreef 9, AZ, Amsterdam, The Netherlands.'}, {'ForeName': 'Osama', 'Initials': 'O', 'LastName': 'Soliman', 'Affiliation': 'Department of Cardiology, Erasmus Medical University Center, Thorax Centre, Molewaterplein 40, GD Rotterdam, The Netherlands.'}, {'ForeName': 'Joanna J', 'Initials': 'JJ', 'LastName': 'Wykrzykowska', 'Affiliation': 'Department of Cardiology, Academic Medical Center, University of Amsterdam, Meibergdreef 9, AZ, Amsterdam, The Netherlands.'}, {'ForeName': 'Robbert J', 'Initials': 'RJ', 'LastName': 'de Winter', 'Affiliation': 'Department of Cardiology, Academic Medical Center, University of Amsterdam, Meibergdreef 9, AZ, Amsterdam, The Netherlands.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Ferrario', 'Affiliation': 'Department of Cardiology, Fondazione IRCCS Policlinico San Matteo, Viale Camillo Golgi, 19, Pavia PV, Italy.'}, {'ForeName': 'Marcello', 'Initials': 'M', 'LastName': 'Dominici', 'Affiliation': 'Department of Cardiology, Azienda Ospedaliera S. Maria, Viale Tristano di Joannuccio, Terni TR, Italy.'}, {'ForeName': 'Paweł', 'Initials': 'P', 'LastName': 'Buszman', 'Affiliation': 'Center for Cardiovascular Research and Development, American Heart of Poland, Sanatoryjna 1, Ustroń, Poland.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Bolognese', 'Affiliation': 'Cardiovascular Department, San Donato Hospital, Via Pietro Nenni, 20/22, 52100 Arezzo, Italy.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Tumscitz', 'Affiliation': 'Department of Cardiology, Azienda Ospedaliero Universitaria di Ferrara, Via Aldo Moro, 8, Cona FE, Italy.'}, {'ForeName': 'Edouard', 'Initials': 'E', 'LastName': 'Benit', 'Affiliation': 'Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa Ziekenhuis, Stadsomvaart 11, 3500 Hasselt, Belgium and Faculty of Medicine and Life Sciences, University of Hasselt, Martelarenlaan 42, Hasselt, Belgium.'}, {'ForeName': 'Hans-Peter', 'Initials': 'HP', 'LastName': 'Stoll', 'Affiliation': 'Biosensors Europe, Rue de Lausanne 29, Morges, Switzerland.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hamm', 'Affiliation': 'Kerckhoff Clinic and Thoraxcenter of the University of Giessen, Benekestraße 2-8, Bad Nauheim, Germany.'}, {'ForeName': 'Philippe Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'Université Paris-Diderot, Hôpital Bichat, Assistance Publique-Hôpitaux de Paris, INSERM U-1148, French Alliance for Cardiovascular Trials, Paris, France.'}, {'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Onuma', 'Affiliation': 'Department of Cardiology, Erasmus Medical University Center, Thorax Centre, Molewaterplein 40, GD Rotterdam, The Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Jüni', 'Affiliation': ""Applied Health Research Centre, Li Ka Shing Knowledge Institute of St Michael's Hospital, Department of Medicine and Institute of Health Policy, Management and Evaluation, University of Toronto, 209 Victoria St, Toronto, ON, Canada.""}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': 'Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Freiburgstrasse 4, Bern, Switzerland.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Vranckx', 'Affiliation': 'Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa Ziekenhuis, Stadsomvaart 11, 3500 Hasselt, Belgium and Faculty of Medicine and Life Sciences, University of Hasselt, Martelarenlaan 42, Hasselt, Belgium.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Colombo', 'Affiliation': 'Department of Cardiology, Maria Cecilia Hospital-GVM, Via Madonna di Genova, 1, Cotignola RA, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Valgimigli', 'Affiliation': 'Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Freiburgstrasse 4, Bern, Switzerland.'}]",European heart journal,['10.1093/eurheartj/ehz453']
1054,32499125,Effect of Acupuncture in Patients With Irritable Bowel Syndrome: A Randomized Controlled Trial.,"OBJECTIVE


To evaluate the effect and safety of acupuncture for the treatment of irritable bowel syndrome (IBS) through comparisons with those of polyethylene glycol (PEG) 4000 and pinaverium bromide.
PATIENTS AND METHODS


This multicenter randomized controlled trial was conducted at 7 hospitals in China and enrolled participants who met the Rome III diagnostic criteria for IBS between May 3, 2015, and June 29, 2018. Participants were first stratified into constipation-predominant or diarrhea-predominant IBS group. Participants in each group were randomly assigned in a 2:1 ratio to receive acupuncture (18 sessions) or PEG 4000 (20 g/d, for IBS-C)/pinaverium bromide (150 mg/d, for IBS-D) over a 6-week period, followed by a 12-week follow-up. The primary outcome was change in total IBS-Symptom Severity Score from baseline to week 6.
RESULTS


Of 531 patients with IBS who were randomized, 519 (344 in the acupuncture group and 175 in the PEG 4000/ pinaverium bromide group) were included in the full analysis set. From baseline to 6 weeks, the total IBS-Symptom Severity Score decreased by 123.51 (95% CI, 116.61 to 130.42) in the acupuncture group and 94.73 (95% CI, 85.03 to 104.43) in the PEG 4000/pinaverium bromide group. The between-group difference was 28.78 (95% CI, 16.84 to 40.72; P<.001). No participant experienced severe adverse effects.
CONCLUSION


Acupuncture may be more effective than PEG 4000 or pinaverium bromide for the treatment of IBS, with effects lasting up to 12 weeks.
TRIAL REGISTRATION


Chinese Clinical Trials Register, ChiCTR-IOR-15006259.",2020,"From baseline to 6 weeks, the total IBS-Symptom Severity Score decreased by 123.51 (95% CI, 116.61 to 130.42) in the acupuncture group and 94.73 (95% CI, 85.03 to 104.43) in the PEG 4000/pinaverium bromide group.","['irritable bowel syndrome (IBS', 'Patients With Irritable Bowel Syndrome', 'Participants were first stratified into constipation-predominant or diarrhea-predominant IBS group', '7 hospitals in China and enrolled participants who met the Rome III diagnostic criteria for IBS between May 3, 2015, and June 29, 2018', '531 patients with IBS who were randomized, 519 (344 in the acupuncture group and 175 in the PEG 4000/ pinaverium bromide group) were included in the full analysis set']","['acupuncture', 'polyethylene glycol (PEG) 4000 and pinaverium bromide', 'Acupuncture', 'acupuncture (18 sessions) or PEG 4000 (20 g/d, for IBS-C)/pinaverium bromide']","['total IBS-Symptom Severity Score', 'severe adverse effects']","[{'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C1262211', 'cui_str': 'Diarrhoea predominant irritable bowel syndrome'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0032483', 'cui_str': 'Polyethylene Glycols'}, {'cui': 'C0137073', 'cui_str': 'Pinaverium bromide'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0032483', 'cui_str': 'Polyethylene Glycols'}, {'cui': 'C3842327', 'cui_str': '4000'}, {'cui': 'C0137073', 'cui_str': 'Pinaverium bromide'}, {'cui': 'C0032479', 'cui_str': 'polyethylene glycol 4000'}, {'cui': 'C0450403', 'cui_str': '20G'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0006222', 'cui_str': 'bromides'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",531.0,0.308207,"From baseline to 6 weeks, the total IBS-Symptom Severity Score decreased by 123.51 (95% CI, 116.61 to 130.42) in the acupuncture group and 94.73 (95% CI, 85.03 to 104.43) in the PEG 4000/pinaverium bromide group.","[{'ForeName': 'Lixia', 'Initials': 'L', 'LastName': 'Pei', 'Affiliation': 'Jiangsu Province Hospital of Chinese Medicine, Nanjing, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Geng', 'Affiliation': 'Jiangsu Province Hospital of Chinese Medicine, Nanjing, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': 'Nanjing University of Chinese Medicine, China.'}, {'ForeName': 'Guohui', 'Initials': 'G', 'LastName': 'Yang', 'Affiliation': 'Shuyang Hospital of Traditional Chinese Medicine, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Shuyang Hospital of Traditional Chinese Medicine, China.'}, {'ForeName': 'Rongrong', 'Initials': 'R', 'LastName': 'Shen', 'Affiliation': 'Nantong Hospital of Traditional Chinese Medicine, China.'}, {'ForeName': 'Shuyu', 'Initials': 'S', 'LastName': 'Xia', 'Affiliation': 'Nantong Hospital of Traditional Chinese Medicine, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Ding', 'Affiliation': 'Wuxi Hospital of Traditional Chinese Medicine, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Feng', 'Affiliation': 'Wuxi Hospital of Traditional Chinese Medicine, China.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': 'Nanjing Hospital of Chinese Medicine affiliated to Nanjing University of Chinese Medicine, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Nanjing Hospital of Chinese Medicine affiliated to Nanjing University of Chinese Medicine, China.'}, {'ForeName': 'Lian', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Affiliated Hospital of Jiangsu University, Zhenjiang, China.'}, {'ForeName': 'Yanye', 'Initials': 'Y', 'LastName': 'Shu', 'Affiliation': 'Affiliated Hospital of Jiangsu University, Zhenjiang, China.'}, {'ForeName': 'Xiangdong', 'Initials': 'X', 'LastName': 'Fang', 'Affiliation': 'Affiliated Hospital of Jiangsu University, Zhenjiang, China; Kunshan Hospital of Traditional Chinese Medicine, China.'}, {'ForeName': 'Xiaoliang', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Jiangsu Province Hospital of Chinese Medicine, Nanjing, China.'}, {'ForeName': 'Xiaoxiao', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Jiangsu Province Hospital of Chinese Medicine, Nanjing, China.'}, {'ForeName': 'Shengjie', 'Initials': 'S', 'LastName': 'Weng', 'Affiliation': 'Nanjing University of Chinese Medicine, China.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Ju', 'Affiliation': 'Nanjing University of Chinese Medicine, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Nanjing University of Chinese Medicine, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Shen', 'Affiliation': 'Jiangsu Province Hospital of Chinese Medicine, Nanjing, China. Electronic address: shenghong999@163.com.'}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Jiangsu Province Hospital of Chinese Medicine, Nanjing, China. Electronic address: 377201634@qq.com.'}]",Mayo Clinic proceedings,['10.1016/j.mayocp.2020.01.042']
1055,32501914,"Effect of Intravenous Aminocaproid Acid on Blood Loss and Transfusion Requirements After Bilateral Varus Rotational Osteotomy: A Double-blind, Placebo-controlled Randomized Trial.","BACKGROUND


ε-Aminocaproic acid (EACA) is an antifibrinolytic agent that has been shown to decrease blood loss and transfusion requirements in several populations undergoing various surgical procedures. However, the efficacy of EACA has not been assessed in pediatric patients with cerebral palsy undergoing bilateral varus rotational femoral osteotomies. The purpose of this study was to assess the efficacy of intravenous EACA in reducing calculated intraoperative blood loss and transfusions in this population.
METHODS


Patients aged 18 years or younger were eligible. Patients were randomized to receive EACA or placebo (saline), and randomization was stratified based on sex and whether or not additional soft tissue or osseous procedures were performed. On the basis of retrospective data, the calculated sample size was 12 patients per arm to detect a difference of 250-mL blood loss. The primary outcome was calculated intraoperative blood loss. Secondary outcomes included transfusion requirements, 24-hour drain output, length of stay, and incidence of complications.
RESULTS


The mean age of patients in this study was 8 years (SD: 2.4 y). There were no differences in age, sex, height, weight, type of anesthesia, operative time, and associated procedures between the EACA and placebo groups (P>0.05). Preoperative hematocrit was lower in the EACA group (37.1 vs. 40.0, P=0.04). Calculated intraoperative blood loss was 536 mL in the EACA group and 628 mL in the placebo group (P=0.45). Transfusions were required in 62% of patients in the EACA group and 67% of patients in the placebo group (P=0.68). Total 24-hour drain output was 72.5 mL in the EACA group and 103.3 mL in the placebo group (P=0.37). Length of stay was similar between both groups, and there were no drug or placebo-related complications in either group.
CONCLUSIONS


There was no difference in blood loss or transfusion requirements associated with EACA compared with placebo; however, this study is underpowered to detect smaller differences in blood loss. Additional studies with larger sample sizes are needed to confirm these findings and further elucidate the indications for antifibrinolytic agents in pediatric patients.
LEVEL OF EVIDENCE


Level I.",2020,Transfusions were required in 62% of patients in the EACA group and 67% of patients in the placebo group (P=0.68).,"['several populations undergoing various surgical procedures', 'pediatric patients', 'After Bilateral Varus Rotational Osteotomy', 'Patients aged 18 years or younger were eligible', 'pediatric patients with cerebral palsy undergoing bilateral varus rotational femoral osteotomies']","['Placebo', 'ε-Aminocaproic acid (EACA', 'EACA', 'EACA or placebo (saline', 'Intravenous Aminocaproid Acid', 'placebo']","['Length of stay', 'blood loss or transfusion requirements', 'Total 24-hour drain output', 'Preoperative hematocrit', '250-mL blood loss', 'Blood Loss and Transfusion Requirements', 'blood loss and transfusion requirements', 'Transfusions', 'calculated intraoperative blood loss', 'transfusion requirements, 24-hour drain output, length of stay, and incidence of complications', 'blood loss', 'Calculated intraoperative blood loss']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0443345', 'cui_str': 'Varus'}, {'cui': 'C0407433', 'cui_str': 'Rotational osteotomy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0445237', 'cui_str': 'Rotational'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0029468', 'cui_str': 'Osteotomy'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0000608', 'cui_str': '6-Aminocaproic Acid'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0001128', 'cui_str': 'Acid'}]","[{'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0013103', 'cui_str': 'Drainage procedure'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",,0.423115,Transfusions were required in 62% of patients in the EACA group and 67% of patients in the placebo group (P=0.68).,"[{'ForeName': 'Ishaan', 'Initials': 'I', 'LastName': 'Swarup', 'Affiliation': ""Division of Pediatric Orthopaedic Surgery, University of California, San Francisco, UCSF Benioff Children's Hospital Oakland, Oakland, CA.""}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Nguyen', 'Affiliation': 'Healthcare Research Institute.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Edmonds', 'Affiliation': 'Division of Anesthesiology.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Dodwell', 'Affiliation': 'Division of Pediatric Orthopaedic Surgery, Hospital for Special Surgery, New York, NY.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Scher', 'Affiliation': 'Division of Pediatric Orthopaedic Surgery, Hospital for Special Surgery, New York, NY.'}]",Journal of pediatric orthopedics,['10.1097/BPO.0000000000001480']
1056,32506275,"Preoperative meloxicam versus postoperative meloxicam for pain control, patients' satisfaction and function recovery in hip osteoarthritis patients who receive total hip arthroplasty: a randomized, controlled study.","This study aimed to compare the analgesic effect, patients' satisfaction, tolerance and hip-joint function recovery by preoperative meloxicam versus postoperative meloxicam in treating hip osteoarthritis (OA) patients receiving total hip arthroplasty (THA). 132 hip OA patients who underwent THA surgery were allocated into postoperative analgesia (POST) and preoperative analgesia (PRE) groups at a 1:1 ratio. In the PRE group, patients took meloxicam 15 mg at 24 h pre-operation, 7.5 mg at 4 h, 24 h, 48 h and 72 h post-operation; in the POST group, patients received meloxicam 15 mg at 4 h post-operation, then 7.5 mg at 24 h, 48 h and 72 h post-operation. Furthermore, postoperative pain, consumption of patient-controlled analgesia (PCA), overall satisfaction and adverse events were evaluated within 96 h post-operation; meanwhile, Harris hip score was assessed within 6 months post-operation. Pain VAS at rest at 6 h, 12 h, 24 h, and pain VAS at passive movement at 6 h, 12 h were decreased in PRE group compared to POST group. In addition, additional consumption of PCA and the total consumption of PCA were both reduced in PRE group compared to POST group. Additionally, overall satisfaction in PRE group was higher at 24 h, 48 h and 72 h compared to POST group. While Harris hip score was of no difference between POST group and PRE group at M3 or M6. Besides, no difference in adverse events incidence was found between the two groups. In conclusion, preoperative meloxicam achieves better efficacy and similar tolerance compared to postoperative meloxicam in hip OA patients post THA.",2020,"In addition, additional consumption of PCA and the total consumption of PCA were both reduced in PRE group compared to POST group.","['hip osteoarthritis patients who receive total hip arthroplasty', '132 hip OA patients who underwent THA surgery', 'treating hip osteoarthritis (OA) patients receiving total hip arthroplasty (THA']","['postoperative analgesia (POST) and preoperative analgesia (PRE', 'meloxicam 15\xa0mg at 4\xa0h post-operation', 'meloxicam', 'Preoperative meloxicam versus postoperative meloxicam', 'meloxicam versus postoperative meloxicam']","['overall satisfaction', 'total consumption of PCA', 'Pain VAS', 'efficacy and similar tolerance', 'adverse events incidence', 'pain VAS at passive movement', ""analgesic effect, patients' satisfaction, tolerance and hip-joint function recovery"", 'Furthermore, postoperative pain, consumption of patient-controlled analgesia (PCA), overall satisfaction and adverse events']","[{'cui': 'C0029410', 'cui_str': 'Osteoarthritis of hip'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C1128682', 'cui_str': 'meloxicam 15 MG'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0083381', 'cui_str': 'meloxicam'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0079991', 'cui_str': 'Passive movement'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019558', 'cui_str': 'Hip joint structure'}, {'cui': 'C0599766', 'cui_str': 'Recovery of Function'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}]",132.0,0.0274409,"In addition, additional consumption of PCA and the total consumption of PCA were both reduced in PRE group compared to POST group.","[{'ForeName': 'Lingyun', 'Initials': 'L', 'LastName': 'Ren', 'Affiliation': ""Department of Anesthesiology, The Central Hospital of Wuhan, Tongji Medical College, Huazhong University of Science and Technology, No. 26, Shengli Street, Wuhan, 430014, People's Republic of China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Meng', 'Affiliation': ""Department of Anesthesiology, The Central Hospital of Wuhan, Tongji Medical College, Huazhong University of Science and Technology, No. 26, Shengli Street, Wuhan, 430014, People's Republic of China.""}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Yan', 'Affiliation': ""Department of Anesthesiology, The Central Hospital of Wuhan, Tongji Medical College, Huazhong University of Science and Technology, No. 26, Shengli Street, Wuhan, 430014, People's Republic of China. haodunye9398649@163.com.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Sun', 'Affiliation': ""Department of Anesthesiology, The Central Hospital of Wuhan, Tongji Medical College, Huazhong University of Science and Technology, No. 26, Shengli Street, Wuhan, 430014, People's Republic of China.""}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Yao', 'Affiliation': ""Department of Anesthesiology, The Central Hospital of Wuhan, Tongji Medical College, Huazhong University of Science and Technology, No. 26, Shengli Street, Wuhan, 430014, People's Republic of China.""}]",Inflammopharmacology,['10.1007/s10787-020-00718-2']
1057,32508221,Acute ingestion of beetroot juice does not improve short-duration repeated sprint running performance in male team sport athletes.,"The effects of acute ingestion of nitrate on short-duration repeated sprint performance (RSP) are unclear. This study investigated the effect of acute ingestion of beetroot juice on a test of RSP in team sport athletes. Sixteen male team sport athletes undertook four trials using a 40 m maximum shuttle run test (MST), which incorporates 10 × 40 m shuttle sprints with 30 s between the start of each sprint. Two familiarisation trials, followed by nitrate-rich beetroot juice (BR; ~6 mmol nitrate) and nitrate-depleted beetroot juice (PLA; ~0.0034 mmol nitrate) trials were completed in a randomised, double-blind manner. Ingestion of beetroot juice 3 h prior to exercise elevated plasma nitrate concentrations ~6-fold in BR (BR, 413 ± 56 μM; PLA, 69 ± 30 μM; P < 0.001). RSP, assessed by sprint performance decrement (S dec ; %), did not differ (P = 0.337) between BR (5.31 ± 2.49%) and PLA (5.71 ± 2.61%). There was no difference between trials for total sprint time (P = 0.806), fastest sprint (P = 0.341), slowest sprint (P = 0.787), or post-exercise blood lactate concentration (BR, 11.8 ± 2.5 mM; PLA, 12.2 ± 2.3 mM; P = 0.109). Therefore, acute ingestion of beetroot juice did not improve a test of short-duration RSP in team sport athletes.",2020,"There was no difference between trials for total sprint time (P = 0.806), fastest sprint (P = 0.341), slowest sprint (P = 0.787), or post-exercise blood lactate concentration (BR, 11.8 ± 2.5 mM; PLA, 12.2 ± 2.3 mM; P = 0.109).","['male team sport athletes', 'Sixteen male team sport athletes', 'team sport athletes']","['nitrate-rich beetroot juice (BR; ~6\xa0mmol nitrate) and nitrate-depleted beetroot juice (PLA; ~0.0034\xa0mmol nitrate', '40 m maximum shuttle run test (MST', 'beetroot juice']","['total sprint time', 'slowest sprint', 'post-exercise blood lactate concentration', 'sprint performance decrement', 'fastest sprint']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C3715157', 'cui_str': '16'}]","[{'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C1095905', 'cui_str': 'Beets preparation'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0456170', 'cui_str': 'Left atrial pressure'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}]",16.0,0.220199,"There was no difference between trials for total sprint time (P = 0.806), fastest sprint (P = 0.341), slowest sprint (P = 0.787), or post-exercise blood lactate concentration (BR, 11.8 ± 2.5 mM; PLA, 12.2 ± 2.3 mM; P = 0.109).","[{'ForeName': 'Ciara M E', 'Initials': 'CME', 'LastName': 'Reynolds', 'Affiliation': 'UCD Institute for Sport & Health, School of Public Health, Physiotherapy, and Sports Science, University College Dublin , Dublin, Ireland.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Evans', 'Affiliation': 'UCD Institute for Sport & Health, School of Public Health, Physiotherapy, and Sports Science, University College Dublin , Dublin, Ireland.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Halpenny', 'Affiliation': 'UCD Institute for Sport & Health, School of Public Health, Physiotherapy, and Sports Science, University College Dublin , Dublin, Ireland.'}, {'ForeName': 'Caoimhe', 'Initials': 'C', 'LastName': 'Hughes', 'Affiliation': 'UCD Institute for Sport & Health, School of Public Health, Physiotherapy, and Sports Science, University College Dublin , Dublin, Ireland.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Jordan', 'Affiliation': 'UCD Institute for Sport & Health, School of Public Health, Physiotherapy, and Sports Science, University College Dublin , Dublin, Ireland.'}, {'ForeName': 'Alyssa', 'Initials': 'A', 'LastName': 'Quinn', 'Affiliation': 'UCD Institute for Sport & Health, School of Public Health, Physiotherapy, and Sports Science, University College Dublin , Dublin, Ireland.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Hone', 'Affiliation': 'School of Health and Human Performance, Dublin City University , Dublin, Ireland.'}, {'ForeName': 'Brendan', 'Initials': 'B', 'LastName': 'Egan', 'Affiliation': 'UCD Institute for Sport & Health, School of Public Health, Physiotherapy, and Sports Science, University College Dublin , Dublin, Ireland.'}]",Journal of sports sciences,['10.1080/02640414.2020.1770409']
1058,32505485,Neuroplastic changes in resting-state functional connectivity after rTMS intervention for methamphetamine craving.,"Amphetamine-type stimulants are the second most commonly abused illicit drug worldwide, with no effective medical treatments currently available. Previous studies have demonstrated that high frequency repetitive transcranial magnetic stimulation (rTMS) over the left dorsolateral prefrontal cortex (DLPFC) reduced cue-induced craving in patients with methamphetamine dependence. However, the neuroplastic mechanism underlying rTMS intervention in methamphetamine users remains to be elucidated. Sixty participants (40 males) with severe methamphetamine use disorder according to DSM-5 were randomized to receive either intermittent theta burst protocols (iTBS) (short bursts of 50 Hz rTMS repeated at a rate in the theta range (5 Hz), 2-sec on, 8-sec off for 5 min; 900 pulses) or sham rTMS over the DLPFC over four weeks (20 daily sessions). Resting state functional connectivity magnetic resonance imaging was acquired before and after rTMS intervention. Participants received drug related cue exposure and rated their craving before and after stimulation. Seed-based functional connectivity analysis was performed to probe rTMS-induced neuroplastic reorganization of brain functional networks. Results showed that twenty daily rTMS sessions decreased craving, increased functional connectivity between left DLPFC and inferior parietal lobule, and decreased functional connectivity between insula and inferior parietal lobule, medial temporal lobe and precuneus. Moreover, the increase of functional connectivity between DLPFC and inferior parietal lobule correlated with craving reduction. This study suggests that neuroplastic changes of frontoparietal functional connectivity contributes to craving reduction, shedding light on the therapeutic effect of rTMS on methamphetamine use disorder. This article is part of the special issue on Stress, Addiction and Plasticity.",2020,"Results showed that twenty daily rTMS sessions decreased craving, increased functional connectivity between left DLPFC and inferior parietal lobule, and decreased functional connectivity between insula and inferior parietal lobule, medial temporal lobe and precuneus.","['patients with methamphetamine dependence', 'Sixty participants (40 males) with severe methamphetamine use disorder according to DSM-5']","['intermittent theta burst protocols (iTBS) (short bursts of 50\u202fHz rTMS repeated at a rate in the theta range (5\u202fHz), 2-sec on, 8-sec off for 5\u202fmin; 900 pulses) or sham rTMS', 'rTMS', 'rTMS intervention', 'repetitive transcranial magnetic stimulation (rTMS', 'Amphetamine-type stimulants']","['craving, increased functional connectivity between left DLPFC and inferior parietal lobule, and decreased functional connectivity between insula and inferior parietal lobule, medial temporal lobe and precuneus', 'functional connectivity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1533217', 'cui_str': 'Methamphetamine dependence'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0059387', 'cui_str': 'staphylococcal enterotoxin C'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4517900', 'cui_str': '900'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002658', 'cui_str': 'Amphetamine'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0002763', 'cui_str': 'Central stimulant'}]","[{'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0152304', 'cui_str': 'Inferior parietal lobule structure'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0021640', 'cui_str': 'Insular structure'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0039485', 'cui_str': 'Temporal lobe structure'}]",60.0,0.0225991,"Results showed that twenty daily rTMS sessions decreased craving, increased functional connectivity between left DLPFC and inferior parietal lobule, and decreased functional connectivity between insula and inferior parietal lobule, medial temporal lobe and precuneus.","[{'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Su', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Yilin', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Institute of Neuroscience, CAS Center for Excellence in Brain Science and Intelligence Technology, State Key Laboratory of Neuroscience, CAS Key Laboratory of Primate Neurobiology, Chinese Academy of Sciences, Shanghai, China; University of Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Dazhi', 'Initials': 'D', 'LastName': 'Yin', 'Affiliation': 'School of Psychology and Cognitive Science, East China Normal University, Shanghai, China.'}, {'ForeName': 'Tianzhen', 'Initials': 'T', 'LastName': 'Chen', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Xiaotong', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Zhong', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Haifeng', 'Initials': 'H', 'LastName': 'Jiang', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Jijun', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'Du', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Xiao', 'Affiliation': 'Shanghai Drug Rehabilitation Administration Bureau, Shanghai, China.'}, {'ForeName': 'Ding', 'Initials': 'D', 'LastName': 'Xu', 'Affiliation': 'Shanghai Drug Rehabilitation Administration Bureau, Shanghai, China.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Zeljic', 'Affiliation': 'Institute of Neuroscience, CAS Center for Excellence in Brain Science and Intelligence Technology, State Key Laboratory of Neuroscience, CAS Key Laboratory of Primate Neurobiology, Chinese Academy of Sciences, Shanghai, China.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Institute of Neuroscience, CAS Center for Excellence in Brain Science and Intelligence Technology, State Key Laboratory of Neuroscience, CAS Key Laboratory of Primate Neurobiology, Chinese Academy of Sciences, Shanghai, China; University of Chinese Academy of Sciences, Beijing, China; CAS Center for Excellence in Brain Science and Intelligence Technology, Chinese Academy of Sciences, Shanghai, 200031, China. Electronic address: zheng.wang@ion.ac.cn.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Zhao', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China; CAS Center for Excellence in Brain Science and Intelligence Technology, Chinese Academy of Sciences, Shanghai, 200031, China; Shanghai Key Laboratory of Psychotic Disorders, Shanghai, China; Institute of Psychological and Behavioral Science, Shanghai Jiao Tong University, Shanghai, China. Electronic address: drminzhao@smhc.org.cn.'}]",Neuropharmacology,['10.1016/j.neuropharm.2020.108177']
1059,32512513,The effects of repetitive transcranial magnetic stimulation on cue-induced craving in male patients with heroin use disorder.,"BACKGROUND


Craving is a central feature of addiction. Early evidence suggests that repetitive transcranial magnetic stimulation is effective in reducing cue induced craving for patients with opioid use disorder (OUD). However, trials in large populations of patients with OUDs are lacking.
METHODS


We randomly assigned 118 male heroin patients into three groups (i.e., 10 Hz rTMS, 1 Hz rTMS and a wait-list control group) from two addiction rehabilitation centers. rTMS was applied to the left dorsolateral prefrontal cortex (DLPFC) for 20 daily consecutive sessions.
FINDINGS


Results showed that 10 Hz rTMS and 1 Hz rTMS were both effective in reducing cue-induced craving scores in heroin users when compared to the wait list group. The treatment effects lasted for up to 60 days after rTMS treatment cessation.
INTERPRETATION


Our results suggest that rTMS applied to the DLPFC is effective in reducing craving severity in heroin use disorder patients. Our results also suggest that such treatment effects can last for up to 60 days after treatment cessation.",2020,"FINDINGS


Results showed that 10 Hz rTMS and 1 Hz rTMS were both effective in reducing cue-induced craving scores in heroin users when compared to the wait list group.","['male patients with heroin use disorder', '118 male heroin patients into three groups (i.e., 10', 'heroin use disorder patients', 'patients with opioid use disorder (OUD']","['repetitive transcranial magnetic stimulation', 'rTMS', 'Hz rTMS, 1\u202fHz rTMS and a wait-list control group) from two addiction rehabilitation centers']","['cue-induced craving scores', 'craving severity']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011892', 'cui_str': 'Heroin'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0085281', 'cui_str': 'Addiction'}, {'cui': 'C0034993', 'cui_str': 'Centers, Rehabilitation'}]","[{'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",118.0,0.0241904,"FINDINGS


Results showed that 10 Hz rTMS and 1 Hz rTMS were both effective in reducing cue-induced craving scores in heroin users when compared to the wait list group.","[{'ForeName': 'Xiaoli', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Shanghai Key Laboratory of Psychotic Disorders, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China; School of Psychology, Nanjing Normal University, Nanjing, Jiangsu, China; Co-innovation Center of Neuroregeneration, Nantong University, Nantong, Jiangsu, China; Ningbo Key Laboratory of Sleep Medicine, Ningbo Kangning Hospital, Ningbo, Zhejiang, China.'}, {'ForeName': 'Xiwen', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Yale Center for Analytical Sciences, School of Public Health, Yale University, New Haven, CT, U.S.A.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Liu', 'Affiliation': 'Shanghai Key Laboratory of Psychotic Disorders, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China; School of Psychology, Nanjing Normal University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Qingming', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Shanghai Key Laboratory of Psychotic Disorders, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China; School of Psychology, Nanjing Normal University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Tang', 'Affiliation': ""Department of Biostatistics, St. Jude Children's Research Hospital, U.S.A.""}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Preventive Medicine, Feinberg School of Medicine, Northwestern University, Chicago, U.S.A.'}, {'ForeName': 'Wenbo', 'Initials': 'W', 'LastName': 'Luo', 'Affiliation': 'Research Center of Brain and Cognitive Neuroscience, Liaoning Normal University, Dalian, China; Key Laboratory of Brain and Cognitive Neurosience, Liaoning Province, China. Electronic address: luowb@lnnu.edu.cn.'}, {'ForeName': 'Zafiris J', 'Initials': 'ZJ', 'LastName': 'Daskalakis', 'Affiliation': 'Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health, University of Toronto, Toronto, Ont., Canada; Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Ti-Fei', 'Initials': 'TF', 'LastName': 'Yuan', 'Affiliation': 'Shanghai Key Laboratory of Psychotic Disorders, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China; Co-innovation Center of Neuroregeneration, Nantong University, Nantong, Jiangsu, China. Electronic address: ytf0707@126.com.'}]",EBioMedicine,['10.1016/j.ebiom.2020.102809']
1060,32512517,Association between cellular HIV-1 DNA level and mortality in HIV-1 infected African adults starting ART with high CD4 counts.,"BACKGROUND


High HIV-1 DNA levels in peripheral blood mononuclear cells (PBMC) were associated with a higher risk of severe morbidity and a faster decline in CD4 count in ART-naive patients. We report the association between HIV-1 DNA and mortality in HIV-infected adults in a trial of early ART in West Africa.
METHODS


In the Temprano trial, HIV-infected adults were randomly assigned to start ART immediately or defer ART. After trial termination, HIV-1 DNA was measured in whole blood samples frozen at baseline. We analyzed the association between baseline PBMC HIV-1 DNA and long-term mortality.
FINDINGS


2019 patients were followed for 9253 patient-years (median 4.9 years). At baseline, the median CD4 count was 462/mm 3  [IQR 368-571], the median plasma HIV-1 RNA 4.7 log 10  copies/ml [IQR 4.0-5.2], and the median HIV-1 DNA 2.9 log 10  copies/million PBMC [IQR 2.5-3.3]. During follow-up, 86 participants died. In univariate analysis, the hazard ratio [HR] of death was 2.67 (95% CI, 1.68-4.22) for patients with HIV-1 DNA ≥3 log 10  copies/million PBMC vs. others, and 2.10 (95% CI, 1.38-3.21) for patients with HIV-1 RNA ≥5 log10 copies/ml vs. others. In multivariate Cox regression analysis, HIV-1 DNA levels ≥3 log 10  copies/million PBMC were strongly associated mortality (adjusted HR = 2.09, 95% CI 1.24-3.52, p= 0.005) while the association between baseline plasma HIV-1 RNA and mortality was not significant.
INTERPRETATION


In these African adults who started ART with high CD4 counts, HIV-1 DNA was a strong independent predictor of death. The HIV reservoir still plays a prognostic role in the early ART era.
FUNDING


This trial was supported by the French National Agency for AIDS and viral hepatitis research (ANRS, Paris, France; Grants ANRS 12136, 12224 and 12253).",2020,"At baseline, the median CD4 count was 462/mm 3  [IQR 368-571], the median plasma HIV-1 RNA 4.7 log 10  copies/ml [IQR 4.0-5.2], and the median HIV-1 DNA 2.9 log 10  copies/million PBMC [IQR 2.5-3.3].","['HIV-infected adults in a trial of early ART in West Africa', '2019 patients were followed for 9253 patient-years (median 4.9 years', 'HIV-infected adults', 'HIV-1 infected African adults starting ART with high CD4 counts']",[],"['median plasma HIV-1 RNA', 'hazard ratio [HR] of death', 'HIV-1 DNA and mortality', 'HIV-1 DNA', 'mortality', 'median CD4 count', 'baseline plasma HIV-1 RNA and mortality', 'CD4 count']","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0001747', 'cui_str': 'Western Africa'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}]",[],"[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0369499', 'cui_str': 'Human immunodeficiency virus 1 RNA'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0486948', 'cui_str': 'Human immunodeficiency virus 1 DNA'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",2019.0,0.300537,"At baseline, the median CD4 count was 462/mm 3  [IQR 368-571], the median plasma HIV-1 RNA 4.7 log 10  copies/ml [IQR 4.0-5.2], and the median HIV-1 DNA 2.9 log 10  copies/million PBMC [IQR 2.5-3.3].","[{'ForeName': 'Jean Baptiste', 'Initials': 'JB', 'LastName': ""N'takpe"", 'Affiliation': ""Centre Inserm 1219, Institut de Recherche pour le Développement (IRD), University of Bordeaux, 146 rue Léo Saignat, 33076 Bordeaux, France; PACCI/ANRS research site in Côte d'Ivoire, Côte d'Ivoire. Electronic address: jean-baptiste.ntakpe@u-bordeaux.fr.""}, {'ForeName': 'Delphine', 'Initials': 'D', 'LastName': 'Gabillard', 'Affiliation': ""Centre Inserm 1219, Institut de Recherche pour le Développement (IRD), University of Bordeaux, 146 rue Léo Saignat, 33076 Bordeaux, France; PACCI/ANRS research site in Côte d'Ivoire, Côte d'Ivoire.""}, {'ForeName': 'Raoul', 'Initials': 'R', 'LastName': 'Moh', 'Affiliation': ""Centre Inserm 1219, Institut de Recherche pour le Développement (IRD), University of Bordeaux, 146 rue Léo Saignat, 33076 Bordeaux, France; PACCI/ANRS research site in Côte d'Ivoire, Côte d'Ivoire; Département de Dermatologie et Maladies Infectieuses, Université Felix Houphouët Boigny, Abidjan, Côte d'Ivoire.""}, {'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Gardiennet', 'Affiliation': 'AP-HP, CHU Necker Enfants Malades, EA 7327 Université Paris Descartes, Paris, France.'}, {'ForeName': 'Arlette', 'Initials': 'A', 'LastName': 'Emieme', 'Affiliation': ""Centre Inserm 1219, Institut de Recherche pour le Développement (IRD), University of Bordeaux, 146 rue Léo Saignat, 33076 Bordeaux, France; PACCI/ANRS research site in Côte d'Ivoire, Côte d'Ivoire; CeDReS, CHU de Treichville, Abidjan, Côte d'Ivoire.""}, {'ForeName': 'Anani', 'Initials': 'A', 'LastName': 'Badje', 'Affiliation': ""Centre Inserm 1219, Institut de Recherche pour le Développement (IRD), University of Bordeaux, 146 rue Léo Saignat, 33076 Bordeaux, France; PACCI/ANRS research site in Côte d'Ivoire, Côte d'Ivoire.""}, {'ForeName': 'Gérard M', 'Initials': 'GM', 'LastName': 'Kouame', 'Affiliation': ""Centre Inserm 1219, Institut de Recherche pour le Développement (IRD), University of Bordeaux, 146 rue Léo Saignat, 33076 Bordeaux, France; PACCI/ANRS research site in Côte d'Ivoire, Côte d'Ivoire.""}, {'ForeName': ""Thomas-d'Aquin"", 'Initials': 'TD', 'LastName': 'Toni', 'Affiliation': ""Centre Inserm 1219, Institut de Recherche pour le Développement (IRD), University of Bordeaux, 146 rue Léo Saignat, 33076 Bordeaux, France; PACCI/ANRS research site in Côte d'Ivoire, Côte d'Ivoire; CeDReS, CHU de Treichville, Abidjan, Côte d'Ivoire.""}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Karcher', 'Affiliation': ""Centre Inserm 1219, Institut de Recherche pour le Développement (IRD), University of Bordeaux, 146 rue Léo Saignat, 33076 Bordeaux, France; PACCI/ANRS research site in Côte d'Ivoire, Côte d'Ivoire.""}, {'ForeName': 'Jérome Le', 'Initials': 'JL', 'LastName': 'Carrou', 'Affiliation': ""Centre Inserm 1219, Institut de Recherche pour le Développement (IRD), University of Bordeaux, 146 rue Léo Saignat, 33076 Bordeaux, France; PACCI/ANRS research site in Côte d'Ivoire, Côte d'Ivoire.""}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Ménan', 'Affiliation': ""Centre Inserm 1219, Institut de Recherche pour le Développement (IRD), University of Bordeaux, 146 rue Léo Saignat, 33076 Bordeaux, France; PACCI/ANRS research site in Côte d'Ivoire, Côte d'Ivoire; CeDReS, CHU de Treichville, Abidjan, Côte d'Ivoire.""}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Danel', 'Affiliation': ""Centre Inserm 1219, Institut de Recherche pour le Développement (IRD), University of Bordeaux, 146 rue Léo Saignat, 33076 Bordeaux, France; PACCI/ANRS research site in Côte d'Ivoire, Côte d'Ivoire.""}, {'ForeName': 'Serge P', 'Initials': 'SP', 'LastName': 'Eholie', 'Affiliation': ""Centre Inserm 1219, Institut de Recherche pour le Développement (IRD), University of Bordeaux, 146 rue Léo Saignat, 33076 Bordeaux, France; PACCI/ANRS research site in Côte d'Ivoire, Côte d'Ivoire; Département de Dermatologie et Maladies Infectieuses, Université Felix Houphouët Boigny, Abidjan, Côte d'Ivoire.""}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Rouzioux', 'Affiliation': ""PACCI/ANRS research site in Côte d'Ivoire, Côte d'Ivoire; AP-HP, CHU Necker Enfants Malades, EA 7327 Université Paris Descartes, Paris, France.""}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Anglaret', 'Affiliation': ""Centre Inserm 1219, Institut de Recherche pour le Développement (IRD), University of Bordeaux, 146 rue Léo Saignat, 33076 Bordeaux, France; PACCI/ANRS research site in Côte d'Ivoire, Côte d'Ivoire.""}]",EBioMedicine,['10.1016/j.ebiom.2020.102815']
1061,32515543,Lower Risk for Severe Hypoglycaemia with Insulin Glargine 300 U/mL vs Glargine 100 U/mL in Participants with Type 1 Diabetes: a Meta-Analysis of 6-Month Phase 3 Clinical Trials.,"Severe hypoglycaemia (SH) remains a challenge to people with type 1 diabetes (T1DM) and new generation basal insulins may improve patient outcomes. This post-hoc meta-analysis explored the risk of SH with insulin glargine 300 U/mL (Gla-300) versus glargine 100 U/mL (Gla-100) in a pooled population with T1DM from three randomised, multicentre, 6-month similarly designed phase 3 trials: EDITION 4, EDITION JP 1, and EDITION JUNIOR. Endpoints included incidence and time to first occurrence of SH. Among 629 and 626 participants randomised to Gla-300 and Gla-100, HbA 1c  reductions were similar. Fewer participants experienced ≥1 SH event with Gla-300 (6.2%) than Gla-100 (9.3%). From baseline to Month 6, the risk of a first SH event was lower with Gla-300: hazard ratio, 0.65 (95% confidence interval [CI] 0.44-0.98; stratified log-rank test, P = 0.038). SH event rates (relative risk [95% CI]) were numerically lower with Gla-300 versus Gla-100 from baseline to Month 6 (0.80 [0.49-1.29; P = 0.356]) and baseline to Week 8 (0.73 [0.37-1.44; P = 0.369]). Thus, Gla-300 demonstrated similar glycaemic control with lower risk of SH versus Gla-100, particularly during the titration period. This article is protected by copyright. All rights reserved.",2020,SH event rates (relative risk [95% CI]) were numerically lower with Gla-300 versus Gla-100 from baseline to Month 6 (0.80 [0.49-1.29; P = 0.356]) and baseline to Week 8 (0.73 [0.37-1.44; P = 0.369]).,['Participants with Type 1 Diabetes'],"['Glargine 100', 'SH with insulin glargine 300 U/mL (Gla-300) versus glargine 100 U/mL', 'Insulin Glargine']","['incidence and time to first occurrence of SH', 'Severe hypoglycaemia (SH', '≥1 SH event with Gla-300', 'risk of a first SH event', 'SH event rates']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4728082', 'cui_str': 'Severe hypoglycaemia'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0439340', 'cui_str': 'kU/L'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C4728082', 'cui_str': 'Severe hypoglycaemia'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0439340', 'cui_str': 'kU/L'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",,0.0663423,SH event rates (relative risk [95% CI]) were numerically lower with Gla-300 versus Gla-100 from baseline to Month 6 (0.80 [0.49-1.29; P = 0.356]) and baseline to Week 8 (0.73 [0.37-1.44; P = 0.369]).,"[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Danne', 'Affiliation': ""Children's Hospital Auf der Bult, Hannover Medical School, Hannover, Germany.""}, {'ForeName': 'Munehide', 'Initials': 'M', 'LastName': 'Matsuhisa', 'Affiliation': 'Diabetes Therapeutics and Research Center, Institute of Advanced Medical Sciences, Tokushima University, Tokushima, Japan.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Sussebach', 'Affiliation': 'Sanofi, Frankfurt am Main, Germany.'}, {'ForeName': 'Harmonie', 'Initials': 'H', 'LastName': 'Goyeau', 'Affiliation': 'Sanofi, Chilly-Mazarin, France.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Lauand', 'Affiliation': 'Sanofi, Paris, France.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Niemoeller', 'Affiliation': 'Sanofi, Frankfurt am Main, Germany.'}, {'ForeName': 'Geremia B', 'Initials': 'GB', 'LastName': 'Bolli', 'Affiliation': 'Section of Endocrinology and Metabolism, Department of Medicine, Perugia University Medical School, Perugia, PG, Italy.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14109']
1062,32512272,Durvalumab vs placebo consolidation therapy after chemoradiotherapy in stage III non-small-cell lung cancer: An updated PACIFIC trial-based cost-effectiveness analysis.,"INTRODUCTION


Recently updated three-year survival data from the PACIFIC trial showed that durvalumab consolidation therapy improved OS rates versus placebo for patients with unresectable stage III non-small cell lung cancer (NSCLC) after chemoradiotherapy. Considering the impact of the high cost of durvalumab, its cost-effectiveness should be updated to see if its cost-effectiveness has changed from the US payers' perspective.
METHODS


A comprehensive Markov model was used to evaluate mean lifetime costs and effectiveness of first-line durvalumab consolidation therapy versus placebo for patients with unresectable stage III NSCLC imputing updated survival and quality-of-life data from the PACIFIC trial. The main endpoints include total costs, life years (LYs), quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs). One-way, two-way, and probabilistic sensitivity analyses were conducted to access the uncertainty in the variables. We also considered durvalumab cost-effectiveness in the subgroups.
RESULTS


Durvalumab consolidation therapy resulted in additional 1.34 LYs and 1.01 QALYs, resulting in an ICER of $138,920 per QALY versus the placebo treatment. One-way sensitivity analysis revealed that the utility values of two treatments, body weight, and unit cost of durvalumab have the greatest influence on the result. Subgroup analyses demonstrated that durvalumab was more cost effective for patients with non-squamous-cell lung cancer, followed by 25% or greater PD-L1 expression. Probabilistic sensitivity analysis showed that the probability of durvalumab being cost-effective versus the placebo is 62.6% at a willingness-to-pay (WTP) of $150,000 per QALY CONCLUSION: Our analyses demonstrated that receiving durvalumab consolidation therapy was more cost-effective than placebo at a WTP threshold of $150,000. These results can be of use to US practitioners in the application of durvalumab and for durvalumab prescription and reimbursement policies.",2020,"Subgroup analyses demonstrated that durvalumab was more cost effective for patients with non-squamous-cell lung cancer, followed by 25% or greater PD-L1 expression.","['patients with unresectable stage III non-small cell lung cancer (NSCLC) after chemoradiotherapy', 'patients with unresectable stage III NSCLC imputing updated survival and quality-of-life data from the PACIFIC trial', 'stage III non-small-cell lung cancer']","['durvalumab consolidation therapy', 'durvalumab', 'Durvalumab vs placebo consolidation therapy after chemoradiotherapy', 'placebo']","['total costs, life years (LYs), quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs', 'mean lifetime costs and effectiveness', 'OS rates', 'cost effective']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278506', 'cui_str': 'Non-small cell lung cancer stage III'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C4055109', 'cui_str': 'durvalumab'}, {'cui': 'C0521530', 'cui_str': 'Lung consolidation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.0947434,"Subgroup analyses demonstrated that durvalumab was more cost effective for patients with non-squamous-cell lung cancer, followed by 25% or greater PD-L1 expression.","[{'ForeName': 'Jiaqi', 'Initials': 'J', 'LastName': 'Han', 'Affiliation': 'Department of Head and Neck Oncology and Department of Radiation Oncology, Cancer Center and State Key Laboratory of Biotherapy, West China Hospital, Sichuan University, Chengdu 610041, PR China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Tian', 'Affiliation': 'Department of Urology, Institute of Urology, West China Hospital, Sichuan University, Chengdu 610041, PR China.'}, {'ForeName': 'Jiangping', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Head and Neck Oncology and Department of Radiation Oncology, Cancer Center and State Key Laboratory of Biotherapy, West China Hospital, Sichuan University, Chengdu 610041, PR China.'}, {'ForeName': 'Youling', 'Initials': 'Y', 'LastName': 'Gong', 'Affiliation': 'Department of Thoracic Oncology and State Key Laboratory of Biotherapy, Cancer Center, West China Hospital, Sichuan University, Chengdu, Sichuan 610041, PR China. Electronic address: gongyouling@hotmail.com.'}]","Lung cancer (Amsterdam, Netherlands)",['10.1016/j.lungcan.2020.05.011']
1063,32515156,A 12-month pilot study outcomes of vagus nerve stimulation in Crohn's disease.,"BACKGROUND


The vagus nerve has anti-inflammatory properties. We aimed to investigate vagus nerve stimulation (VNS) as a new therapeutic strategy targeting an intrinsic anti-inflammatory pathway in a pilot study in Crohn's disease patients. The main objectives addressed the questions of long-term safety, tolerability, and anti-inflammatory effects of this therapy. This study is the continuation of previous reported findings at 6 months.
METHODS


Nine patients with moderate active disease underwent VNS. An electrode wrapped around the left cervical vagus nerve was continuously stimulated over 1 year. Clinical, biological, endoscopic parameters, cytokines (plasma, gut), and mucosal metabolites were followed-up.
KEY RESULTS


After 1 year of VNS, five patients were in clinical remission and six in endoscopic remission. C-reactive protein (CRP) and fecal calprotectin decreased in six and five patients, respectively. Seven patients restored their vagal tone and decreased their digestive pain score. The patients' cytokinergic profile evolved toward a more ""healthy profile"": Interleukins 6, 23, 12, tumor necrosis factor α, and transforming growth factorβ1 were the most impacted cytokines. Correlations were observed between CRP and tumor necrosis factor α, and some gut mucosa metabolites as taurine, lactate, alanine, and beta-hydroxybutyrate. VNS was well tolerated.
CONCLUSION & INFERENCES


Vagus nerve stimulation appears as an innovative and well-tolerated treatment in moderate Crohn's disease. After 12 months, VNS has restored a homeostatic vagal tone and reduced the inflammatory state of the patients. VNS has probably a global modulatory effect on the immune system along with gut metabolic regulations. This pilot study needs replication in a larger randomized double-blinded control study.",2020,"Correlations were observed between CRP and tumor necrosis factor α, and some gut mucosa metabolites as taurine, lactate, alanine, and beta-hydroxybutyrate.","['patients\' cytokinergic profile evolved toward a more ""healthy profile', ""Crohn's disease patients"", ""Crohn's disease"", 'Nine patients with moderate active disease underwent VNS']","['vagus nerve stimulation', 'vagus nerve stimulation (VNS']","['vagal tone', 'clinical remission and six in endoscopic remission', 'tolerated', 'CRP and tumor necrosis factor α, and some gut mucosa metabolites as taurine, lactate, alanine, and beta-hydroxybutyrate', 'C-reactive protein (CRP) and fecal calprotectin', 'digestive pain score', 'tumor necrosis factor α, and transforming growth factorβ1', 'homeostatic vagal tone', 'Clinical, biological, endoscopic parameters, cytokines (plasma, gut), and mucosal metabolites']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332253', 'cui_str': 'Evolving'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}]","[{'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0039350', 'cui_str': 'Taurine'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0001898', 'cui_str': 'Alanine'}, {'cui': 'C0106006', 'cui_str': '3-hydroxybutyrate'}, {'cui': 'C1964053', 'cui_str': 'Faecal calprotectin'}, {'cui': 'C0012238', 'cui_str': 'Digestive system function'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}]",5.0,0.0874017,"Correlations were observed between CRP and tumor necrosis factor α, and some gut mucosa metabolites as taurine, lactate, alanine, and beta-hydroxybutyrate.","[{'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Sinniger', 'Affiliation': 'Inserm, U1216, Grenoble Institute Neurosciences, University of Grenoble Alpes, Grenoble, France.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Pellissier', 'Affiliation': 'University of Grenoble Alpes, University of Savoie Mont Blanc and LIP/PC2S, Grenoble, France.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Fauvelle', 'Affiliation': 'Inserm, U1216, Grenoble Institute Neurosciences, University of Grenoble Alpes, Grenoble, France.'}, {'ForeName': 'Candice', 'Initials': 'C', 'LastName': 'Trocmé', 'Affiliation': 'BEP Laboratory Building, University of Grenoble Alpes Hospital, Grenoble, France.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Hoffmann', 'Affiliation': 'Neurosurgery Department, Grenoble Alpes Hospital, University of Grenoble Alpes Hospital, Grenoble, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Vercueil', 'Affiliation': 'Inserm, U1216, Grenoble Institute Neurosciences, University of Grenoble Alpes, Grenoble, France.'}, {'ForeName': 'Jean-Luc', 'Initials': 'JL', 'LastName': 'Cracowski', 'Affiliation': 'INSERM CIC1406, University of Grenoble Alpes Hospital, Grenoble, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'David', 'Affiliation': 'Inserm, U1216, Grenoble Institute Neurosciences, University of Grenoble Alpes, Grenoble, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Bonaz', 'Affiliation': 'Inserm, U1216, Grenoble Institute Neurosciences, University of Grenoble Alpes, Grenoble, France.'}]",Neurogastroenterology and motility : the official journal of the European Gastrointestinal Motility Society,['10.1111/nmo.13911']
1064,32517582,Frequency and Predictors of Major Bleeding in Patients With Embolic Strokes of Undetermined Source: NAVIGATE-ESUS Trial.,"BACKGROUND AND PURPOSE


Risks, sites, and predictors of major bleeding during antithrombotic therapies have not been well defined for patients with recent embolic stroke of undetermined source.
METHODS


Exploratory analysis of major bleeds defined by International Society of Thrombosis and Hemostasis criteria occurring among 7213 participants in international NAVIGATE (New Approach Rivaroxaban Inhibition of Factor Xa in a Global Trial) embolic stroke of undetermined source randomized trial comparing rivaroxaban 15 mg daily with aspirin 100 mg daily.
RESULTS


During a median follow-up of 11 months, 85 major bleeds occurred. The most frequent site was gastrointestinal (38%), followed by intracranial (29%). Assignment to rivaroxaban (hazard ratio [HR], 2.7 [95% CI, 1.7-4.3]), East Asia region (HR, 2.5 [95% CI, 1.6-3.9]), systolic blood pressure ≥160 mm Hg (HR, 2.2 [95% CI, 1.2-3.8]), and reduced estimated glomerular filtration rate (HR, 1.2 per 10 mL/min per 1.73 m 2  decrease, [95% CI, 1.0-1.3]) were independently associated with presence of major bleeds. Five (6%) were fatal. Among 15 patients with intracerebral hemorrhage, 2 (13%) were fatal. There was no evidence of an early high-risk period following initiation of rivaroxaban. The annualized rate of intracerebral hemorrhage was 6-fold higher among East Asian participants (0.67%) versus all other regions (0.11%; HR, 6.3 [95% CI, 2.2-18.0]). Distribution of bleeding sites was similar for rivaroxaban and aspirin.
CONCLUSIONS


Among embolic stroke of undetermined source patients participating in an international randomized trial, independent predictors of major bleeding were assignment to rivaroxaban, East Asia region, increased systolic blood pressure, and impaired renal function. East Asia as a region was strongly associated with risk of intracerebral hemorrhage. Estimated glomerular filtration rate should be a consideration for stratifying bleeding risk. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02313909.",2020,"The annualized rate of intracerebral hemorrhage was 6-fold higher among East Asian participants (0.67%) versus all other regions (0.11%; HR, 6.3 [95% CI, 2.2-18.0]).","['Patients With Embolic Strokes of Undetermined Source', 'patients with recent embolic stroke of undetermined source', 'Exploratory analysis of major bleeds defined by International Society of Thrombosis and Hemostasis criteria occurring among 7213 participants in international NAVIGATE (New Approach Rivaroxaban Inhibition of Factor Xa in a Global trial) embolic stroke', '15 patients with intracerebral hemorrhage, 2 (13%) were fatal']","['rivaroxaban', 'rivaroxaban 15 mg daily with aspirin 100 mg daily']","['annualized rate of intracerebral hemorrhage', 'systolic blood pressure, and impaired renal function', 'systolic blood pressure', 'glomerular filtration rate', 'Distribution of bleeding sites']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3888970', 'cui_str': 'Embolic stroke of undetermined source'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C3160769', 'cui_str': 'Major bleed'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0015520', 'cui_str': 'Coagulation factor Xa'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0262469', 'cui_str': 'Embolic stroke'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}]","[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C3247999', 'cui_str': 'rivaroxaban 15 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1124475', 'cui_str': 'Aspirin 100 MG'}]","[{'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0205145', 'cui_str': 'Site'}]",15.0,0.431584,"The annualized rate of intracerebral hemorrhage was 6-fold higher among East Asian participants (0.67%) versus all other regions (0.11%; HR, 6.3 [95% CI, 2.2-18.0]).","[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Mikulík', 'Affiliation': ""International Clinical Research Center and Neurology Department, St. Anne's University Hospital and Masaryk University Brno, Czech Republic (R.M.).""}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Eckstein', 'Affiliation': 'Department of Internal Medicine, University Hospital Basel, Switzerland (J.E.).'}, {'ForeName': 'Lesly A', 'Initials': 'LA', 'LastName': 'Pearce', 'Affiliation': 'Biostatistics Consultant, Minot, ND (L.A.P.).'}, {'ForeName': 'Hardi', 'Initials': 'H', 'LastName': 'Mundl', 'Affiliation': 'Bayer AG, Wuppertal, Germany (H.M.).'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Rudilosso', 'Affiliation': 'Comprehensive Stroke Center, Department of Neuroscience (S.R.), Hospital Clinic, Barcelona, Spain.'}, {'ForeName': 'Veroníca V', 'Initials': 'VV', 'LastName': 'Olavarría', 'Affiliation': 'Department of Neurology and Psychiatry, Faculty of Medicine, Universidad del Desarrollo, Clínica Alemana de Santiago, Santiago, Chile (V.V.O.).'}, {'ForeName': 'Ashkan', 'Initials': 'A', 'LastName': 'Shoamanesh', 'Affiliation': 'McMaster University/Population Health Research Institute, Hamilton Health Sciences, ON, Canada (A.S., S.J.C., R.G.H.).'}, {'ForeName': 'Ángel', 'Initials': 'Á', 'LastName': 'Chamorro', 'Affiliation': 'Comprehensive Stroke Center, Department of Neuroscience (A.C.), Hospital Clinic, Barcelona, Spain.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Martí-Fàbregas', 'Affiliation': 'Hospital de La Santa Creu Isant Pau, Barcelona, Spain (J.M.-F.).'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Veltkamp', 'Affiliation': 'Imperial College London, United Kingdom (R.V.).'}, {'ForeName': 'Şerefnur', 'Initials': 'Ş', 'LastName': 'Öztürk', 'Affiliation': 'Department of Neurology, Selcuk University Faculty of Medicine, Turkey (S.O.).'}, {'ForeName': 'Turgut', 'Initials': 'T', 'LastName': 'Tatlisumak', 'Affiliation': 'Department of Clinical Neuroscience, Institute of Neuroscience and Physiology, Sahlgrenska Academy at University of Gothenburg, Sweden (T.T.).'}, {'ForeName': 'W Frank', 'Initials': 'WF', 'LastName': 'Peacock', 'Affiliation': 'Baylor College of Medicine, Houston, TX (W.F.P.).'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Berkowitz', 'Affiliation': 'Pharmaceuticals Clinical Development Thrombosis, Bayer U.S. LLC, Whippany, NJ (S.D.B.).'}, {'ForeName': 'Stuart J', 'Initials': 'SJ', 'LastName': 'Connolly', 'Affiliation': 'McMaster University/Population Health Research Institute, Hamilton Health Sciences, ON, Canada (A.S., S.J.C., R.G.H.).'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Hart', 'Affiliation': 'McMaster University/Population Health Research Institute, Hamilton Health Sciences, ON, Canada (A.S., S.J.C., R.G.H.).'}]",Stroke,['10.1161/STROKEAHA.119.027995']
1065,32517785,Implementing self-management: a mixed methods study of women's experiences of a postpartum hypertension intervention (SNAP-HT).,"BACKGROUND


Self-management strategies are effective in a number of medical conditions; however, implementation studies have demonstrated adoption into clinical practice can be problematic. The process of implementation was explored during a pilot randomised controlled trial evaluating postpartum blood pressure self-management in women with medicated hypertensive disorders of pregnancy.
METHODS


A mixed methods study using semi-structured interviews with a qualitative and a scored (quantitative) component were undertaken as part of a pilot randomised controlled trial (SNAP-HT) in postnatal women with medicated gestational hypertension or pre-eclampsia. Women were randomised to usual care or blood pressure self-management. Self-management entailed daily home blood pressure monitoring and automated medication reduction via telemonitoring. Women from both groups optionally consented to participate in audio-recorded interviews at 4 weeks and 6 months postpartum. Interview questions were developed to explore the proposed benefits of self-management and the constructs of normalisation process theory. Participants provided a score (Likert scale 1-5) for each question and were encouraged to expand upon these answers through further discussion. The interviews were transcribed and analysed using the framework approach.
RESULTS


Sixty-eight women, 34 from each randomised group, completed at least one audio-recorded interview. Several overarching themes emerged from analysis of 126 interview transcripts: control; convenience; confidence, communication and knowledge; concern; constraints; and components of the intervention. In the scored component of the analysis, both groups reported feeling more in control of their condition postpartum compared to during pregnancy, more so in those self-managing at both 4 weeks and 6 months: adjusted differences 0.6 (95% confidence interval [CI] 0.2 to 1.1) and 0.7 (95% CI 0.3 to 1.2) respectively.
CONCLUSIONS


Interviews and quantitative data showed that self-management enhanced women's sense of control and improved their blood pressure-related anxiety. Prior to taking part, a few women anticipated that home monitoring might increase anxiety, but stated that it had the opposite effect. Self-management was perceived as more flexible and reactive and as enabling more targeted down-titration of medication. These data provide considerable support for blood pressure self-management postpartum and reinforce the effectiveness of the intervention used in this study.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT02333240. Prospectively registered on 7 January 2015.",2020,"In the scored component of the analysis, both groups reported feeling more in control of their condition postpartum compared to during pregnancy, more so in those self-managing at both 4 weeks and 6 months: adjusted differences 0.6 (95% confidence interval [CI] 0.2 to 1.1) and 0.7 (95% CI 0.3 to 1.2) respectively.
","[""women's experiences of a postpartum hypertension intervention (SNAP-HT"", 'postnatal women with medicated gestational hypertension or pre-eclampsia', 'women with medicated hypertensive disorders of pregnancy']","['usual care or blood pressure self-management', 'postpartum blood pressure self-management', 'Self-management entailed daily home blood pressure monitoring and automated medication reduction via telemonitoring']",['blood pressure-related anxiety'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1177045', 'cui_str': 'Snap'}, {'cui': 'C0443281', 'cui_str': 'Postnatal'}, {'cui': 'C0341934', 'cui_str': 'Transient hypertension of pregnancy'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0852260', 'cui_str': 'Hypertension associated disorders of pregnancy'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1449681', 'cui_str': 'Home Blood Pressure Monitoring'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",68.0,0.101051,"In the scored component of the analysis, both groups reported feeling more in control of their condition postpartum compared to during pregnancy, more so in those self-managing at both 4 weeks and 6 months: adjusted differences 0.6 (95% confidence interval [CI] 0.2 to 1.1) and 0.7 (95% CI 0.3 to 1.2) respectively.
","[{'ForeName': 'Alexandra E', 'Initials': 'AE', 'LastName': 'Cairns', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Primary Care, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK. alexandra.cairns@doctors.org.uk.'}, {'ForeName': 'Katherine L', 'Initials': 'KL', 'LastName': 'Tucker', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Primary Care, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Crawford', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Primary Care, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'McManus', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Primary Care, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Powell', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Primary Care, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK.'}]",Trials,['10.1186/s13063-020-04394-z']
1066,32510158,Nondigestible Carbohydrates Affect Metabolic Health and Gut Microbiota in Overweight Adults after Weight Loss.,"BACKGROUND


The composition of diets consumed following weight loss (WL) can have a significant impact on satiety and metabolic health.
OBJECTIVE


This study was designed to test the effects of including a nondigestible carbohydrate to achieve weight maintenance (WM) following a period of WL.
METHODS


Nineteen volunteers [11 females and 8 males, aged 20-62 y; BMI (kg/m2): 27-42] consumed a 3-d maintenance diet (15%:30%:55%), followed by a 21-d WL diet (WL; 30%:30%:40%), followed by 2 randomized 10-d WM diets (20%:30%:50% of energy from protein:fat:carbohydrate) containing either resistant starch type 3 (RS-WM; 22 or 26 g/d for females and males, respectively) or no RS (C-WM) in a within-subject crossover design without washout periods. The primary outcome, WM after WL, was analyzed by body weight. Secondary outcomes of fecal microbiota composition and microbial metabolite concentrations and gut hormones were analyzed in fecal samples and blood plasma, respectively. All outcomes were assessed at the end of each dietary period.
RESULTS


Body weight was similar after the RS-WM and C-WM diets (90.7 and 90.8 kg, respectively), with no difference in subjectively rated appetite. During the WL diet period plasma ghrelin increased by 36% (P < 0.001), glucose-dependent insulinotropic polypeptide (GIP) decreased by 33% (P < 0.001), and insulin decreased by 46% (P < 0.001), but no significant differences were observed during the RS-WM and C-WM diet periods. Fasting blood glucose was lower after the RS-WM diet (5.59 ± 0.31 mmol/L) than after the C-WM diet [5.75 ± 0.49 mmol/L; P = 0.015; standard error of the difference between the means (SED): 0.09]. Dietary treatments influenced the fecal microbiota composition (R2 = 0.054, P = 0.031) but not diversity.
CONCLUSIONS


The metabolic benefits, for overweight adults, from WL were maintained through a subsequent WM diet with higher total carbohydrate intake. Inclusion of resistant starch in the WM diet altered gut microbiota composition positively and resulted in lower fasting glucose compared with the control, with no apparent change in appetite. This trial was registered at clinicaltrials.gov as NCT01724411.",2020,"Inclusion of resistant starch in the WM diet altered gut microbiota composition positively and resulted in lower fasting glucose compared with the control, with no apparent change in appetite.","['Overweight Adults after Weight Loss', 'Nineteen volunteers', '11 females and 8 males, aged 20-62 y; BMI (kg/m2): 27-42']","['Nondigestible Carbohydrates', 'nondigestible carbohydrate', 'resistant starch type 3 (RS-WM']","['glucose-dependent insulinotropic polypeptide (GIP', 'weight maintenance (WM', 'fecal samples and blood plasma', 'plasma ghrelin', 'insulin', 'Fasting blood glucose', 'appetite', 'Body weight', 'fecal microbiota composition and microbial metabolite concentrations and gut hormones', 'fecal microbiota composition', 'gut microbiota composition', 'subjectively rated appetite', 'lower fasting glucose']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}]","[{'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0038179', 'cui_str': 'Starch'}, {'cui': 'C0441731', 'cui_str': 'Type 3'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]","[{'cui': 'C0017132', 'cui_str': 'Gastric inhibitory polypeptide'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}]",19.0,0.0602516,"Inclusion of resistant starch in the WM diet altered gut microbiota composition positively and resulted in lower fasting glucose compared with the control, with no apparent change in appetite.","[{'ForeName': 'Alexandra M', 'Initials': 'AM', 'LastName': 'Johnstone', 'Affiliation': 'The Rowett Institute, University of Aberdeen, Foresterhill, United Kingdom.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Kelly', 'Affiliation': 'Functional and Comparative Genomics, and Psychological Sciences, University of Liverpool, Liverpool, United Kingdom.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Ryan', 'Affiliation': 'Functional and Comparative Genomics, and Psychological Sciences, University of Liverpool, Liverpool, United Kingdom.'}, {'ForeName': 'Reyna', 'Initials': 'R', 'LastName': 'Romero-Gonzalez', 'Affiliation': 'The Rowett Institute, University of Aberdeen, Foresterhill, United Kingdom.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'McKinnon', 'Affiliation': 'The Rowett Institute, University of Aberdeen, Foresterhill, United Kingdom.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Fyfe', 'Affiliation': 'The Rowett Institute, University of Aberdeen, Foresterhill, United Kingdom.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Naslund', 'Affiliation': 'Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Ruben', 'Initials': 'R', 'LastName': 'Lopez-Nicolas', 'Affiliation': 'Department of Food Science and Nutrition, Faculty of Veterinary Sciences, Regional Campus of International Excellence ""Campus Mare Nostrum"", University of Murcia, Murcia, Spain.'}, {'ForeName': 'Douwina', 'Initials': 'D', 'LastName': 'Bosscher', 'Affiliation': 'Cargill R&D Centre Europe, Vilvoorde, Belgium.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Bonnema', 'Affiliation': 'Cargill R&D Centre NA, Minneapolis, MN, USA.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Frontela-Saseta', 'Affiliation': 'Department of Food Science and Nutrition, Faculty of Veterinary Sciences, Regional Campus of International Excellence ""Campus Mare Nostrum"", University of Murcia, Murcia, Spain.'}, {'ForeName': 'Gaspar', 'Initials': 'G', 'LastName': 'Ros-Berruezo', 'Affiliation': 'Department of Food Science and Nutrition, Faculty of Veterinary Sciences, Regional Campus of International Excellence ""Campus Mare Nostrum"", University of Murcia, Murcia, Spain.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Horgan', 'Affiliation': 'Biomathematics and Statistics Scotland, Aberdeen, United Kingdom.'}, {'ForeName': 'Xiaolei', 'Initials': 'X', 'LastName': 'Ze', 'Affiliation': 'The Rowett Institute, University of Aberdeen, Foresterhill, United Kingdom.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Harrold', 'Affiliation': 'Appetite and Obesity Research Group, Department of Psychological Sciences, University of Liverpool, Liverpool, United Kingdom.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Halford', 'Affiliation': 'Appetite and Obesity Research Group, Department of Psychological Sciences, University of Liverpool, Liverpool, United Kingdom.'}, {'ForeName': 'Silvia W', 'Initials': 'SW', 'LastName': 'Gratz', 'Affiliation': 'The Rowett Institute, University of Aberdeen, Foresterhill, United Kingdom.'}, {'ForeName': 'Sylvia H', 'Initials': 'SH', 'LastName': 'Duncan', 'Affiliation': 'The Rowett Institute, University of Aberdeen, Foresterhill, United Kingdom.'}, {'ForeName': 'Soraya', 'Initials': 'S', 'LastName': 'Shirazi-Beechey', 'Affiliation': 'Functional and Comparative Genomics, and Psychological Sciences, University of Liverpool, Liverpool, United Kingdom.'}, {'ForeName': 'Harry J', 'Initials': 'HJ', 'LastName': 'Flint', 'Affiliation': 'The Rowett Institute, University of Aberdeen, Foresterhill, United Kingdom.'}]",The Journal of nutrition,['10.1093/jn/nxaa124']
1067,32512477,"Effect of a maximal exercise test on serum and urinary concentrations of magnesium, phosphorous, rubidium and strontium in athletes.","AIM


This study aims to determine the changes induced by a maximal exercise test until exhaustion on the serum and urinary concentrations of Magnesium (Mg), Phosphorous (P), Rubidium (Rb) and Strontium (Sr) in athletes (AG) and sedentary students (SG).
METHODS


Fifty subjects participated in the study divided into two groups. In AG there were twenty-five male athletes and in SG there were twenty-five male sedentary students. Both groups performed an exercise test until exhaustion, starting at 8 or 10 km/h respectively, and increasing the speed at 1 km/h every 400 m. Serum and urine samples were obtained from all participants before and after the test.
RESULTS


Regarding the basal status, AG showed lower values of Mg in serum (p < 0.05) and urine (p < 0.01), but higher concentrations of serum P (p < 0.05) in comparison to SG. Comparing the pre and post-test values, corrected or non-corrected for hemoconcentration in serum and for creatinine in urine, AG showed a decrease in serum Mg (p < 0.05), in serum P (p < 0.01) and in urinary Sr (p < 0.01) while an increase was observed in urinary P (p < 0.05) and in urinary Rb (p < 0.05).
CONCLUSIONS


It can be concluded that a treadmill test until exhaustion leads to changes in serum and urinary concentrations of minerals in both AG and SG males. This may reflect an adaptive response of the body to overcome the physical stress and, in some cases, to avoid loss of these elements.",2020,"Regarding the basal status, AG showed lower values of Mg in serum (p < 0.05) and urine (p < 0.01), but higher concentrations of serum P (p < 0.05) in comparison to SG.","['athletes', 'athletes (AG) and sedentary students (SG', 'In AG there were twenty-five male athletes and in SG there were twenty-five male sedentary students', 'Fifty subjects participated in the study divided into two groups']",['maximal exercise test'],"['urinary Rb', 'serum and urinary concentrations of Magnesium (Mg), Phosphorous (P), Rubidium (Rb) and Strontium (Sr', 'urinary Sr', 'serum and urinary concentrations of magnesium, phosphorous, rubidium and strontium']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}]","[{'cui': 'C0035930', 'cui_str': 'Rubidium'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0232827', 'cui_str': 'Urinary concentration'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C0038467', 'cui_str': 'Strontium'}]",25.0,0.0207851,"Regarding the basal status, AG showed lower values of Mg in serum (p < 0.05) and urine (p < 0.01), but higher concentrations of serum P (p < 0.05) in comparison to SG.","[{'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Muñoz', 'Affiliation': 'Exercise Physiology Lab, Sport Sciences Faculty, University of Extremadura, Avenida De La Universidad s/n, 10003, Cáceres, Spain. Electronic address: diegomun@unex.es.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Grijota', 'Affiliation': 'Exercise Physiology Lab, Sport Sciences Faculty, University of Extremadura, Avenida De La Universidad s/n, 10003, Cáceres, Spain. Electronic address: fgrijota@gmail.com.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Siquier-Coll', 'Affiliation': 'Exercise Physiology Lab, Sport Sciences Faculty, University of Extremadura, Avenida De La Universidad s/n, 10003, Cáceres, Spain. Electronic address: jsiquier@alumnos.unex.es.'}, {'ForeName': 'Víctor', 'Initials': 'V', 'LastName': 'Toro-Román', 'Affiliation': 'Exercise Physiology Lab, Sport Sciences Faculty, University of Extremadura, Avenida De La Universidad s/n, 10003, Cáceres, Spain. Electronic address: vtororom@alumnos.unex.es.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Bartolomé', 'Affiliation': 'Exercise Physiology Lab, Sport Sciences Faculty, University of Extremadura, Avenida De La Universidad s/n, 10003, Cáceres, Spain. Electronic address: ignbs.1991@gmail.com.'}, {'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'Maynar-Mariño', 'Affiliation': 'Exercise Physiology Lab, Sport Sciences Faculty, University of Extremadura, Avenida De La Universidad s/n, 10003, Cáceres, Spain. Electronic address: mmaynar@unex.es.'}]",Journal of trace elements in medicine and biology : organ of the Society for Minerals and Trace Elements (GMS),['10.1016/j.jtemb.2020.126572']
1068,32513312,Dietary supplementation with seed oil from transgenic  Camelina sativa  induces similar increments in plasma and erythrocyte DHA and EPA to fish oil in healthy humans.,"EPA and DHA are required for normal cell function and can also induce health benefits. Oily fish are the main source of EPA and DHA for human consumption. However, food choices and concerns about the sustainability of marine fish stocks limit the effectiveness of dietary recommendations for EPA + DHA intakes. Seed oils from transgenic plants that contain EPA + DHA are a potential alternative source of EPA and DHA. The present study investigated whether dietary supplementation with transgenic Camelina sativa seed oil (CSO) that contained EPA and DHA was as effective as fish oil (FO) in increasing EPA and DHA concentrations when consumed as a dietary supplement in a blinded crossover study. Healthy men and women (n 31; age 53 (range 20-74) years) were randomised to consume 450 mg/d EPA + DHA provided either as either CSO or FO for 8 weeks, followed by 6 weeks washout and then switched to consuming the other test oil. Fasting venous blood samples were collected at the start and end of each supplementation period. Consuming the test oils significantly (P < 0·05) increased EPA and DHA concentrations in plasma TAG, phosphatidylcholine and cholesteryl esters. There were no significant differences between test oils in the increments of EPA and DHA. There was no significant difference between test oils in the increase in the proportion of erythrocyte EPA + DHA (CSO, 12 %; P < 0·0001 and FO, 8 %; P = 0·02). Together, these findings show that consuming CSO is as effective as FO for increasing EPA and DHA concentrations in humans.",2020,"Consuming the test oils significantly (P < 0.05) increased EPA and DHA concentrations in plasma triacylglycerol, phosphatidylcholine and cholesteryl esters.","['healthy humans', 'Healthy men and women (n 31; age 53 (20-74) yrs']","['dietary supplementation with transgenic Camelina sativa seed oil (CSO) that contained EPA and DHA', 'consume 450 mg/day EPA+DHA provided either as either CSO or FO']","['EPA and DHA concentrations in plasma triacylglycerol, phosphatidylcholine and cholesteryl esters', 'EPA and DHA', 'proportion of erythrocyte EPA+DHA', 'Fasting venous blood samples']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0003069', 'cui_str': 'Transgenic Animals'}, {'cui': 'C3474157', 'cui_str': 'CAMELINA SATIVA SEED OIL'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0142831', 'cui_str': 'sodium dehydroacetate'}, {'cui': 'C3844104', 'cui_str': '450'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}]","[{'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0142831', 'cui_str': 'sodium dehydroacetate'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C1959616', 'cui_str': 'Lecithin'}, {'cui': 'C0008387', 'cui_str': 'Cholesterol ester'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0444255', 'cui_str': 'Venous blood specimen'}]",,0.0929784,"Consuming the test oils significantly (P < 0.05) increased EPA and DHA concentrations in plasma triacylglycerol, phosphatidylcholine and cholesteryl esters.","[{'ForeName': 'Annette L', 'Initials': 'AL', 'LastName': 'West', 'Affiliation': 'School of Human Development and Health, Faculty of Medicine, University of Southampton, SouthamptonSO16 6YD, UK.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Miles', 'Affiliation': 'School of Human Development and Health, Faculty of Medicine, University of Southampton, SouthamptonSO16 6YD, UK.'}, {'ForeName': 'Karen A', 'Initials': 'KA', 'LastName': 'Lillycrop', 'Affiliation': 'Centre for Biological Sciences, Faculty of Natural and Environmental Sciences, University of Southampton, SouthamptonSO17 1BJ, UK.'}, {'ForeName': 'Lihua', 'Initials': 'L', 'LastName': 'Han', 'Affiliation': 'Department of Plant Sciences, Rothamsted Research, HarpendenAL5 2JQ, UK.'}, {'ForeName': 'Johnathan A', 'Initials': 'JA', 'LastName': 'Napier', 'Affiliation': 'Department of Plant Sciences, Rothamsted Research, HarpendenAL5 2JQ, UK.'}, {'ForeName': 'Philip C', 'Initials': 'PC', 'LastName': 'Calder', 'Affiliation': 'School of Human Development and Health, Faculty of Medicine, University of Southampton, SouthamptonSO16 6YD, UK.'}, {'ForeName': 'Graham C', 'Initials': 'GC', 'LastName': 'Burdge', 'Affiliation': 'School of Human Development and Health, Faculty of Medicine, University of Southampton, SouthamptonSO16 6YD, UK.'}]",The British journal of nutrition,['10.1017/S0007114520002044']
1069,32520984,Effect of various exercises on frailty among older adults with subjective cognitive concerns: a randomised controlled trial.,"BACKGROUND


Physical exercise has been linked to reduced frailty, but there is insufficient evidence of beneficial effects in community-dwelling older adults with subjective cognitive concerns.
OBJECTIVE


This study aimed to clarify the effects of physical exercise in this population.
DESIGN


Single-blind randomised controlled trial.
SETTING


Community sports centres.
PARTICIPANTS


Residents aged 65-85 years were screened using the Kihon checklist; those with subjective cognitive concerns were invited for eligibility assessment. In total, 415 community-dwelling older adults were enrolled and randomised.
METHODS


This trial investigated the effects of aerobic training (AT), resistance training (RT) and combined training (AT+RT) programs on reducing frailty. All participants were randomised into one of the three intervention groups or the control group. Participants in the intervention groups underwent a group training program and self-paced home training for 26 weeks. The control group received lectures about health promotion. A 95-item frailty index (FI) was utilised to determine the effects of training. Participants were followed up at weeks 26 and 52.
RESULTS


At baseline, mean age of all participants (47% women) was 72.3 ± 4.6 years, with a mean FI score of 0.3 ± 0.1. Compared with control group, AT improved total FI by 0.020 (CI -0.039 to -0.001, effect size -0.275) and the depression and anxiety component of FI by 0.051 (CI -0.084 to -0.018, effect size -0.469) at week 26, but the effects waned at week 52. No significant differences in FI were found in RT and AT+RT groups at weeks 26 and 52.
CONCLUSIONS


A 26-week AT reduced frailty modestly, especially in the depression and anxiety component, in older adults with subjective cognitive concerns.",2020,"Compared with control group, AT improved total FI by 0.020 (CI -0.039 to -0.001, effect size -0.275) and the depression and anxiety component of FI by 0.051 (CI -0.084 to -0.018, effect size -0.469) at week 26, but the effects waned at week 52.","['Community sports centres', 'older adults with subjective cognitive concerns', '415 community-dwelling older adults', 'Residents aged 65-85\xa0years were screened using the Kihon checklist; those with subjective cognitive concerns were invited for eligibility assessment', 'community-dwelling older adults with subjective cognitive concerns']","['various exercises', 'lectures about health promotion', 'aerobic training (AT), resistance training (RT) and combined training (AT+RT) programs', 'physical exercise', 'group training program and self-paced home training']","['FI', 'total FI', 'depression and anxiety component of FI']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C4517772', 'cui_str': '415'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0018738', 'cui_str': 'Health promotion'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0287990', 'cui_str': 'Furin'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]","[{'cui': 'C4075886', 'cui_str': 'Frailty Index'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449432', 'cui_str': 'Component'}]",415.0,0.0634744,"Compared with control group, AT improved total FI by 0.020 (CI -0.039 to -0.001, effect size -0.275) and the depression and anxiety component of FI by 0.051 (CI -0.084 to -0.018, effect size -0.469) at week 26, but the effects waned at week 52.","[{'ForeName': 'Chi Hsien', 'Initials': 'CH', 'LastName': 'Huang', 'Affiliation': 'Department of Community Healthcare and Geriatrics, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Umegaki', 'Affiliation': 'Department of Community Healthcare and Geriatrics, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Taeko', 'Initials': 'T', 'LastName': 'Makino', 'Affiliation': 'Department of Community Healthcare and Geriatrics, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Kazuki', 'Initials': 'K', 'LastName': 'Uemura', 'Affiliation': 'Department of Community Healthcare and Geriatrics, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Hayashi', 'Affiliation': 'Department of Community Healthcare and Geriatrics, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Tomoharu', 'Initials': 'T', 'LastName': 'Kitada', 'Affiliation': 'Department of Community Healthcare and Geriatrics, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Aiko', 'Initials': 'A', 'LastName': 'Inoue', 'Affiliation': 'Department of Community Healthcare and Geriatrics, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Shimada', 'Affiliation': 'Department of Preventive Gerontology, Center for Gerontology and Social Science, National Center for Geriatrics and Gerontology, Obu City, Japan.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Kuzuya', 'Affiliation': 'Department of Community Healthcare and Geriatrics, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}]",Age and ageing,['10.1093/ageing/afaa086']
1070,32515740,Coach-Facilitated Web-Based Therapy Compared With Information About Web-Based Resources in Patients Referred to Secondary Mental Health Care for Depression: Randomized Controlled Trial.,"BACKGROUND


Depression is a common mental disorder with a high social burden and significant impact on suicidality and quality of life. Treatment is often limited to drug therapies because of long waiting times to see psychological therapists face to face, despite several guidelines recommending that psychological treatments should be first-line interventions for mild to moderate depression.
OBJECTIVE


We aimed to evaluate, among patients on a waitlist to receive secondary mental health care services for depression, how effective coach-guided web-based therapy (The Journal) is, compared with an information-only waitlist control group, in reducing depression symptoms after 12 weeks.
METHODS


We conducted a randomized controlled trial with 2 parallel arms and a process evaluation, which included interviews with study participants. Participants assigned to the intervention group received 12 weeks of web-based therapy guided by a coach who had a background in social work. Patients in the control group receive a leaflet of mental health resources they could access. The primary outcome measure was a change in depression scores, as measured by the Patient-Health Questionnaire (PHQ-9).
RESULTS


A total of 95 participants were enrolled (intervention, n=47; control, n=48). The mean change in PHQ-9 scores from baseline to week 12 was -3.6 (SD 6.6) in the intervention group and -3.1 (SD 6.2) in the control group, which was not a statistically significant difference with a two-sided alpha of .05 (t 91 =-0.37; P=.72, 95% CI -3.1 to 2.2). At 12 weeks, participants in the intervention group reported higher health-related quality of life (mean EuroQol 5 dimensions visual analogue scale [EQ-5D-VAS] score 66.8, SD 18.0) compared with the control group (mean EQ-5D VAS score 55.9, SD 19.2; t 84 =-2.73; P=.01). There were no statistically significant differences between the two groups in health service use following their initial consultation with a psychiatrist. The process evaluation showed that participants in the intervention group completed a mean of 5.0 (SD 2.3) lessons in The Journal and 8.8 (SD 3.1) sessions with the coach. Most participants (29/47, 62%) in the intervention group who completed the full dose of the intervention, by finishing 6 or more lessons in The Journal, were more likely to have a clinically important reduction in depressive symptoms at 12 weeks compared with the control group (Χ 2 1 =6.3; P=.01, Φ=0.37). Participants who completed the interviews reported that the role played by the coach was a major factor in adherence to the study intervention.
CONCLUSIONS


The results demonstrate that the use of guided web-based therapy for the treatment of depression is not more effective than information-only waitlist control. However, it showed that the coach has the potential to increase adherence and engagement with web-based depression treatment protocols. Further research is needed on what makes the coach effective.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT02423733; https://clinicaltrials.gov/ct2/show/NCT02423733.",2020,The results demonstrate that the use of guided web-based therapy for the treatment of depression is not more effective than information-only waitlist control.,"['95 participants were enrolled (intervention, n=47; control, n=48', 'patients on a waitlist to receive secondary mental health care services for depression', 'Patients Referred to Secondary Mental Health Care for Depression']","['web-based therapy guided by a coach who had a background in social work', 'leaflet of mental health resources they could access', 'guided web-based therapy', 'Coach-Facilitated Web-Based Therapy Compared With Information About Web-Based Resources']","['depressive symptoms', 'change in depression scores, as measured by the Patient-Health Questionnaire (PHQ-9', 'higher health-related quality of life (mean EuroQol 5 dimensions visual analogue scale [EQ-5D-VAS] score', 'mean change in PHQ-9 scores']","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0184643', 'cui_str': 'Mental health care'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0037441', 'cui_str': 'Social Service'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0444454', 'cui_str': 'Access'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",95.0,0.1837,The results demonstrate that the use of guided web-based therapy for the treatment of depression is not more effective than information-only waitlist control.,"[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'MacLean', 'Affiliation': 'School of Journalism and Communication, Carleton University, Ottawa, ON, Canada.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Corsi', 'Affiliation': 'Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada.'}, {'ForeName': 'Sadie', 'Initials': 'S', 'LastName': 'Litchfield', 'Affiliation': 'Prevention and Rehabilitation, University of Ottawa Heart Institute, Ottawa, ON, Canada.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Kucharski', 'Affiliation': 'Department of Psychiatry, The Ottawa Hospital, Ottawa, ON, Canada.'}, {'ForeName': 'Kira', 'Initials': 'K', 'LastName': 'Genise', 'Affiliation': 'Faculty of Medicine, University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'Zeynep', 'Initials': 'Z', 'LastName': 'Selaman', 'Affiliation': 'Department of Psychiatry, University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Testa', 'Affiliation': 'Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Hatcher', 'Affiliation': 'Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada.'}]",Journal of medical Internet research,['10.2196/15001']
1071,32518060,Guided Self-Help Behavioral Activation Intervention for Geriatric Depression: Protocol for Pilot Randomized Controlled Trial.,"BACKGROUND


Aging is a social concern. The increased incidence of depression in older populations in China poses a challenge to the health care system. Older adults who are depressed often suffer from a lack of motivation. Behavioral activation treatment, an evidence-based guided self-help treatment, is effective in reducing anhedonia and amotivation in depression; however, the efficacy of guided self-help behavioral activation in older adults with depression is not yet known.
OBJECTIVE


The aim of this study is to pilot a self-help guided intervention for the treatment of depression in older adults.
METHODS


This study has been designed as a pilot randomized controlled trial with inpatients (n=60; to be randomly allocated 1:1) between the ages of 60 and 70 and who have major depressive disorder. Patients attending clinical psychological clinics at the Mental Health Center of Chongqing will be randomized to either receive guided self-help behavioral activation (intervention) or to be on a 6-week waiting list (control). Participants in the treatment group will receive 6 sessions of guided self-help behavioral activation delivered over the telephone. The waiting list control group will receive the intervention after a period of 6 weeks. Exclusion criteria will be individuals who are at significant risk of harming themselves or others, who have a primary mental health disorder other than depression, or who have an intellectual disability that would hamper their ability to participate in the intervention. Effects of the treatment will be observed using outcomes in 3 domains: (1) clinical outcomes (symptom severity, recovery rate), (2) process variables (patient satisfaction, attendance, dropout), and (3) economic outcomes (cost and resource use). We will also examine mediators of outcomes in terms of patient variables (behavioral activation or inhibition motivation). We hypothesize that guided self-help behavioral activation will have a beneficial effect.
RESULTS


The study was approved by the research ethics committee of the Mental Health Center of Chongqing in November 2019. As of July 2020, recruitment had not yet begun. Data collection is expected to be completed by December 2020. Data analysis is expected to be completed by June 2021. Results will then be disseminated to patients, to the public, to clinicians, and to researchers through publications in journals and presentations at conferences.
CONCLUSIONS


This will be the first study in China to investigate guided self-help interventions for patients who are older adults and who are depressed, a group which is currently underrepresented in mental health research. The intervention is modular and adapted from an empirically supported behavioral activation treatment for depression. The generalizability and broad inclusion criteria are strengths.
TRIAL REGISTRATION


Chinese Clinical Trial Register ChiCTR1900026066; http://www.chictr.org.cn/showprojen.aspx?proj=43548.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


PRR1-10.2196/18259.",2020,"RESULTS


Effects of the treatment were observed on three outcomes domains: (1) clinical outcomes (symptom severity, recovery rates); (2) process variables (patient satisfaction, attendance, dropout); and (3) economic outcomes (cost and resource use).","['geriatric depression', 'Chinese older populations', 'elderly depressed patients', 'China geriatric depressed patients, a group which is currently under-represented in mental health research', 'Participants attending clinical psychological clinics at Mental Health Center of Chongqing', 'elderly patients', '30 elderly inpatients with major depressive disorder', 'Depressed older adults']","['Evidence-based guided self-help behavioral activation (BA) treatment', 'guided self-help interventions', 'guided self-help BA intervention or to a 6-week waiting list control', '6 sessions of guided self-help BA intervention delivered over the telephone', 'guided self-help Behavioral Activation intervention']","['three outcomes domains: (1) clinical outcomes (symptom severity, recovery rates); (2) process variables (patient satisfaction, attendance, dropout); and (3) economic outcomes (cost and resource use']","[{'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0009474', 'cui_str': 'CMHC'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}]","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",30.0,0.053098,"RESULTS


Effects of the treatment were observed on three outcomes domains: (1) clinical outcomes (symptom severity, recovery rates); (2) process variables (patient satisfaction, attendance, dropout); and (3) economic outcomes (cost and resource use).","[{'ForeName': 'Xiaoxia', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Basic Psychology, College of Psychology, Army Medical University, Chongqing, China.'}, {'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Department of Clinical Psychology, Mental Health Center of Chongqing, Chongqing, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'Department of Clinical Psychology, Mental Health Center of Chongqing, Chongqing, China.'}]",JMIR research protocols,['10.2196/18259']
1072,32519972,Continuous Monitoring of Vital Signs in the General Ward Using Wearable Devices: Randomized Controlled Trial.,"BACKGROUND


Wearable devices can be used for continuous patient monitoring in the general ward, increasing patient safety. Little is known about the experiences and expectations of patients and health care professionals regarding continuous monitoring with these devices.
OBJECTIVE


This study aimed to identify positive and negative effects as well as barriers and facilitators for the use of two wearable devices: ViSi Mobile (VM) and HealthPatch (HP).
METHODS


In this randomized controlled trial, 90 patients admitted to the internal medicine and surgical wards of a university hospital in the Netherlands were randomly assigned to continuous vital sign monitoring using VM or HP and a control group. Users' experiences and expectations were addressed using semistructured interviews. Nurses, physician assistants, and medical doctors were also interviewed. Interviews were analyzed using thematic content analysis. Psychological distress was assessed using the State Trait Anxiety Inventory and the Pain Catastrophizing Scale. The System Usability Scale was used to assess the usability of both devices.
RESULTS


A total of 60 patients, 20 nurses, 3 physician assistants, and 6 medical doctors were interviewed. We identified 47 positive and 30 negative effects and 19 facilitators and 36 barriers for the use of VM and HP. Frequently mentioned topics included earlier identification of clinical deterioration, increased feelings of safety, and VM lines and electrodes. No differences related to psychological distress and usability were found between randomization groups or devices.
CONCLUSIONS


Both devices were well received by most patients and health care professionals, and the majority of them encouraged the idea of monitoring vital signs continuously in the general ward. This comprehensive overview of barriers and facilitators of using wireless devices may serve as a guide for future researchers, developers, and health care institutions that consider implementing continuous monitoring in the ward.
TRIAL REGISTRATION


Clinicaltrials.gov NCT02933307; http://clinicaltrials.gov/ct2/show/NCT02933307.",2020,"No differences related to psychological distress and usability were found between randomization groups or devices.
","['90 patients admitted to the internal medicine and surgical wards of a university hospital in the Netherlands', '60 patients, 20 nurses, 3 physician assistants, and 6 medical doctors were interviewed']","['Wearable Devices', 'continuous vital sign monitoring using VM or HP and a control group', 'two wearable devices: ViSi Mobile (VM) and HealthPatch (HP']","['feelings of safety, and VM lines and electrodes', 'State Trait Anxiety Inventory and the Pain Catastrophizing Scale', 'Psychological distress', 'psychological distress and usability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021782', 'cui_str': 'Internal medicine'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0031833', 'cui_str': 'Physician assistant'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}]","[{'cui': 'C4505348', 'cui_str': 'Wearable Technology'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0013812', 'cui_str': 'Electrode'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}]",90.0,0.0887291,"No differences related to psychological distress and usability were found between randomization groups or devices.
","[{'ForeName': 'Mariska', 'Initials': 'M', 'LastName': 'Weenk', 'Affiliation': 'Radboud University Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'Sebastian J', 'Initials': 'SJ', 'LastName': 'Bredie', 'Affiliation': 'Radboud University Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Koeneman', 'Affiliation': 'Radboud University Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'Gijs', 'Initials': 'G', 'LastName': 'Hesselink', 'Affiliation': 'Radboud University Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'van Goor', 'Affiliation': 'Radboud University Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'Tom H', 'Initials': 'TH', 'LastName': 'van de Belt', 'Affiliation': 'Radboud University Medical Center, Nijmegen, Netherlands.'}]",Journal of medical Internet research,['10.2196/15471']
1073,32520900,Associations of pituitary-ovarian hormones and white matter hyperintensities in recently menopausal women using hormone therapy.,"OBJECTIVE


Little is known about how menopausal hormone treatment (HT) may influence the development of white matter hyperintensities (WMHs) in the brain. This study evaluated the associations of changes in levels of pituitary-ovarian hormones during HT and changes in WMH.
METHODS


Women (n = 78 adherent to treatment) enrolled in the Kronos Early Estrogen Prevention Study underwent brain magnetic resonance imaging, and blood collection before and after 48 months of randomization to 0.45 mg/d oral conjugated equine estrogen (oCEE) daily, 50 μg/d transdermal 17β estradiol (tE2), or placebo pills and patches. Women in the active treatment groups also received oral 200 mg/d micronized progesterone the first 12 days of the month. Estradiol (E2), estrone (E1), follicle-stimulating hormone (FSH), and luteinizing hormone (LH) were measured in serum by high sensitivity liquid chromatography/mass spectrometry at baseline and following 48 months of HT. Longitudinal change in WMH volume was determined from fluid-attenuated inversion recovery magnetic resonance imaging using a semiautomated image segmentation algorithm.
RESULTS


Serum levels of FSH, LH, E1, or E2 did not associate with WMH volume at baseline. After 48 months of treatment, smaller increases in WMH associated with decreases in FSH from baseline in the tE2 group and increases in E1 in both tE2 and oCEE groups. Changes in LH did not associate with changes in WMH in any group.
CONCLUSIONS


Circulating levels of pituitary-ovarian hormones associate with changes in WMH volume in recently menopausal women using HT. Whether these relationships would be influenced by different doses of tE2 or oCEE remains to be determined. : Video Summary:http://links.lww.com/MENO/A590.",2020,"RESULTS


Serum levels of FSH, LH, E1, or E2 did not associate with WMH volume at baseline.","['Women (n\u200a=\u200a78 adherent to treatment) enrolled in the Kronos', '50']","['transdermal 17β estradiol (tE2), or placebo pills and patches', ' Video Summary:http://links.lww.com/MENO/A590', 'brain magnetic resonance imaging, and blood collection before and after 48 months of randomization to 0.45\u200amg/d oral conjugated equine estrogen (oCEE', 'hormone therapy', 'menopausal hormone treatment (HT', 'oral 200\u200amg/d micronized progesterone']","['Estradiol (E2), estrone (E1), follicle-stimulating hormone (FSH), and luteinizing hormone (LH', 'WMH', 'Serum levels of FSH, LH, E1, or E2', 'levels of pituitary-ovarian hormones', 'FSH', 'WMH volume']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0040652', 'cui_str': 'Transdermal route'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4068884', 'cui_str': '0.45'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0019944', 'cui_str': 'Equus caballus'}, {'cui': 'C0014939', 'cui_str': 'Estrogens'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}]","[{'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0014942', 'cui_str': 'Estrone'}, {'cui': 'C0202022', 'cui_str': 'Follicle stimulating hormone measurement'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032002', 'cui_str': 'Disorder of pituitary gland'}, {'cui': 'C0729511', 'cui_str': 'Ovarian hormone'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",,0.216075,"RESULTS


Serum levels of FSH, LH, E1, or E2 did not associate with WMH volume at baseline.","[{'ForeName': 'Juliana M', 'Initials': 'JM', 'LastName': 'Kling', 'Affiliation': ""Division of Women's Health Internal Medicine, Mayo Clinic, Scottsdale, AZ, 13737 North 92nd Street, Scottsdale, AZ 85260.""}, {'ForeName': 'Virginia M', 'Initials': 'VM', 'LastName': 'Miller', 'Affiliation': 'Departments of Surgery and Physiology and Biomedical Engineering, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Nirubol', 'Initials': 'N', 'LastName': 'Tosakulwong', 'Affiliation': 'Department of Health Sciences Research, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Lesnick', 'Affiliation': 'Department of Health Sciences Research, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Kejal', 'Initials': 'K', 'LastName': 'Kantarci', 'Affiliation': 'Department of Radiology, Mayo Clinic, Rochester, MN.'}]","Menopause (New York, N.Y.)",['10.1097/GME.0000000000001557']
1074,32524297,Extrapolation of Survival Benefits in Patients with Transthyretin Amyloid Cardiomyopathy Receiving Tafamidis: Analysis of the Tafamidis in Transthyretin Cardiomyopathy Clinical Trial.,"INTRODUCTION


In the Tafamidis in Transthyretin Cardiomyopathy Clinical Trial (ATTR-ACT; ClinicalTrials.gov number NCT01994889), tafamidis reduced the risk of all-cause mortality in patients with transthyretin amyloid cardiomyopathy (ATTR-CM) by 30% versus placebo. Median overall survival was not achieved in either treatment arm (57.1 and 70.5% of patients in the placebo and tafamidis groups, respectively, survived at 30 months), limiting assessment of the potential survival benefits of treatment.
METHODS


A survival extrapolation analysis was conducted following technical support guidelines from the National Institute for Health and Care Excellence. Multiple models (i.e., exponential, Weibull, gamma, log-logistic, log-normal, Gompertz, generalized gamma, and generalized F) were applied to systematically fit different candidate curves to existing patient-level data from the 30-month treatment period in ATTR-ACT. The relative goodness-of-fit for each candidate curve was then tested by Akaike's and Bayesian information criteria to select a single model that was fitted to the placebo and pooled tafamidis treatment arms.
RESULTS


A gamma distribution was selected as best fitting model and fitted to both treatment arms. The resulting estimated median overall survival was 35.16 months for placebo and 52.64 months for tafamidis (difference 17.48 months).
CONCLUSIONS


This extrapolation of survival data from ATTR-ACT further supports the efficacy of tafamidis in patients with ATTR-CM. Owing to the limitations of this analysis, these survival estimates should be interpreted with caution; however, they are consistent with recently presented findings from a combined analysis of data from ATTR-ACT and interim data from an ongoing long-term extension study (median follow-up 36 months; ClinicalTrials.gov number NCT02791230).
TRIAL REGISTRATION


ClinicalTrials.gov: NCT01994889.",2020,"The resulting estimated median overall survival was 35.16 months for placebo and 52.64 months for tafamidis (difference 17.48 months).
","['patients with transthyretin amyloid cardiomyopathy (ATTR-CM) by 30% versus', 'patients with ATTR-CM', 'Patients with Transthyretin Amyloid Cardiomyopathy Receiving Tafamidis']",['placebo'],"['Median overall survival', 'median overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032923', 'cui_str': 'Prealbumin'}, {'cui': 'C0268407', 'cui_str': 'Senile cardiac amyloidosis'}, {'cui': 'C2745274', 'cui_str': 'tafamidis'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.496993,"The resulting estimated median overall survival was 35.16 months for placebo and 52.64 months for tafamidis (difference 17.48 months).
","[{'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': 'Pfizer, New York, NY, USA. Benjamin.Li@pfizer.com.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Alvir', 'Affiliation': 'Pfizer, New York, NY, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Stewart', 'Affiliation': 'Pfizer, Groton, CT, USA.'}]",Cardiology and therapy,['10.1007/s40119-020-00179-2']
1075,32513581,Effects of soy isoflavones on serum lipids and lipoprotein (a) in peritoneal dialysis patients.,"BACKGROUND AND AIM


Lipid abnormalities are common in peritoneal dialysis (PD) patients and no effective treatment to decrease serum lipoprotein (a) [Lp(a)] in dialysis patients is known so far. Therefore, this research was designed to investigate the effects of soy isoflavone supplement on serum lipids and Lp(a) in PD patients.
METHODS & RESULTS


In this randomized, double-blind, placebo-controlled trial, 40 PD patients were randomly assigned to either the isoflavone or the placebo group. The patients in the isoflavone group received 100 mg soy isoflavone daily for 8 weeks, whereas the placebo group received corresponding placebos. At baseline and the end of the 8th week, 7 mL of blood was obtained from each patient and serum triglycerides, total cholesterol, low density lipoprotein-cholesterol (LDL-C), high density lipoprotein-cholesterol (HDL-C), and Lp(a) were measured. Serum Lp(a) reduced significantly up to 10% in the isoflavone group at the end of week 8 compared to baseline (P < 0.05), and the reduction was significant in comparison with the placebo group (P < 0.05). Serum HDL-C increased significantly up to 11.5% in the isoflavone group at the end of week 8 compared to baseline (P = 0.05), and the increment was significant in comparison with the placebo group (P < 0.05). There were no significant differences between the two groups in mean changes of serum triglycerides, total cholesterol, and LDL-C.
CONCLUSIONS


This study indicates that daily administration of 100 mg soy isoflavones reduces serum Lp(a) and increases HDL-C concentration which are two determinants of cardiovascular disease in PD patients. CLINICALTRIALS.GOV: NCT03773029.
REGISTRATION NUMBER AND DATE


NCT03773029 - 2018.",2020,"There were no significant differences between the two groups in mean changes of serum triglycerides, total cholesterol, and LDL-C.
","['peritoneal dialysis (PD) patients', 'PD patients', 'peritoneal dialysis patients', '40 PD patients']","['soy isoflavone supplement', 'placebos', 'isoflavone', '100\xa0mg soy isoflavones', 'soy isoflavones', '100\xa0mg soy isoflavone', 'placebo']","['serum lipoprotein (a) [Lp(a', 'HDL-C concentration', 'mean changes of serum triglycerides, total cholesterol, and LDL-C', 'Serum Lp(a', 'serum lipids and lipoprotein (a', 'Serum HDL-C', 'serum triglycerides, total cholesterol, low density lipoprotein-cholesterol (LDL-C), high density lipoprotein-cholesterol (HDL-C), and Lp(a', 'serum Lp(a', 'serum lipids and Lp(a']","[{'cui': 'C0031139', 'cui_str': 'Peritoneal dialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C4076257', 'cui_str': 'Soy isoflavone'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0022179', 'cui_str': 'Isoflavone Derivatives'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0023820', 'cui_str': 'Lipoprotein'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0542495', 'cui_str': 'Measurement of serum triglyceride level'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0428462', 'cui_str': 'Measurement of serum lipid level'}]",40.0,0.329101,"There were no significant differences between the two groups in mean changes of serum triglycerides, total cholesterol, and LDL-C.
","[{'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Yari', 'Affiliation': 'National Nutrition and Food Technology Research Institute, Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Islamic Republic of Iran. Electronic address: zahrayari_nut@yahoo.com.'}, {'ForeName': 'Hadi', 'Initials': 'H', 'LastName': 'Tabibi', 'Affiliation': 'Department of Clinical Nutrition & Dietetics, National Nutrition and Food Technology Research Institute, Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Islamic Republic of Iran. Electronic address: hadtabibi@yahoo.com.'}, {'ForeName': 'Iraj', 'Initials': 'I', 'LastName': 'Najafi', 'Affiliation': 'Department of Nephrology, Tehran University of Medical Sciences, Tehran, Islamic Republic of Iran. Electronic address: NAJAFI63800@yahoo.com.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Hedayati', 'Affiliation': 'Cellular and Molecular Endocrine Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Islamic Republic of Iran. Electronic address: Hedayati@endocrine.ac.ir.'}, {'ForeName': 'Mina', 'Initials': 'M', 'LastName': 'Movahedian', 'Affiliation': 'National Nutrition and Food Technology Research Institute, Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Islamic Republic of Iran. Electronic address: nutritionist1993@gmail.com.'}]","Nutrition, metabolism, and cardiovascular diseases : NMCD",['10.1016/j.numecd.2020.04.023']
1076,32519676,Spelling Errors and Shouting Capitalization Lead to Additive Penalties to Trustworthiness of Online Health Information: Randomized Experiment With Laypersons.,"BACKGROUND


The written format and literacy competence of screen-based texts can interfere with the perceived trustworthiness of health information in online forums, independent of the semantic content. Unlike in professional content, the format in unmoderated forums can regularly hint at incivility, perceived as deliberate rudeness or casual disregard toward the reader, for example, through spelling errors and unnecessary emphatic capitalization of whole words (online shouting).
OBJECTIVE


This study aimed to quantify the comparative effects of spelling errors and inappropriate capitalization on ratings of trustworthiness independently of lay insight and to determine whether these changes act synergistically or additively on the ratings.
METHODS


In web-based experiments, 301 UK-recruited participants rated 36 randomized short stimulus excerpts (in the format of information from an unmoderated health forum about multiple sclerosis) for trustworthiness using a semantic differential slider. A total of 9 control excerpts were compared with matching error-containing excerpts. Each matching error-containing excerpt included 5 instances of misspelling, or 5 instances of inappropriate capitalization (shouting), or a combination of 5 misspelling plus 5 inappropriate capitalization errors. Data were analyzed in a linear mixed effects model.
RESULTS


The mean trustworthiness ratings of the control excerpts ranged from 32.59 to 62.31 (rating scale 0-100). Compared with the control excerpts, excerpts containing only misspellings were rated as being 8.86 points less trustworthy, those containing inappropriate capitalization were rated as 6.41 points less trustworthy, and those containing the combination of misspelling and capitalization were rated as 14.33 points less trustworthy (P<.001 for all). Misspelling and inappropriate capitalization show an additive effect.
CONCLUSIONS


Distinct indicators of incivility independently and additively penalize the perceived trustworthiness of online text independently of lay insight, eliciting a medium effect size.",2020,The mean trustworthiness ratings of the control excerpts ranged from 32.59 to 62.31 (rating scale 0-100).,['301 UK-recruited participants rated 36'],"['inappropriate capitalization (shouting), or a combination of 5 misspelling plus 5 inappropriate capitalization errors', 'spelling errors and inappropriate capitalization', 'randomized short stimulus excerpts (in the format of information from an unmoderated health forum about multiple sclerosis) for trustworthiness using a semantic differential slider']",['mean trustworthiness ratings'],"[{'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}]","[{'cui': 'C3542467', 'cui_str': 'Inappropriate'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C1301627', 'cui_str': 'Format'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0036611', 'cui_str': 'Differential, Semantic'}, {'cui': 'C1005353', 'cui_str': 'Trachemys'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.0768117,The mean trustworthiness ratings of the control excerpts ranged from 32.59 to 62.31 (rating scale 0-100).,"[{'ForeName': 'Harry J', 'Initials': 'HJ', 'LastName': 'Witchel', 'Affiliation': 'Department of Neuroscience, Brighton and Sussex Medical School, Brighton, United Kingdom.'}, {'ForeName': 'Georgina A', 'Initials': 'GA', 'LastName': 'Thompson', 'Affiliation': 'Department of Neuroscience, Brighton and Sussex Medical School, Brighton, United Kingdom.'}, {'ForeName': 'Christopher I', 'Initials': 'CI', 'LastName': 'Jones', 'Affiliation': 'Department of Primary Care and Public Health, Brighton and Sussex Medical School, Brighton, United Kingdom.'}, {'ForeName': 'Carina E I', 'Initials': 'CEI', 'LastName': 'Westling', 'Affiliation': 'Faculty of Media and Communication, Bournemouth University, Bournemouth, United Kingdom.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Romero', 'Affiliation': 'Dalton Maag Ltd, London, United Kingdom.'}, {'ForeName': 'Alessia', 'Initials': 'A', 'LastName': 'Nicotra', 'Affiliation': 'Dalton Maag Ltd, London, United Kingdom.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Maag', 'Affiliation': 'Dalton Maag Ltd, London, United Kingdom.'}, {'ForeName': 'Hugo D', 'Initials': 'HD', 'LastName': 'Critchley', 'Affiliation': 'Department of Neuroscience, Brighton and Sussex Medical School, Brighton, United Kingdom.'}]",Journal of medical Internet research,['10.2196/15171']
1077,32521448,Design cues for tobacco communication: Heuristic interpretations and usability of online health information about harmful chemicals.,"OBJECTIVE


Many people have a poor understanding of the numerous chemicals in tobacco products that cause severe health harms. The US government must display a list of these harmful chemicals for the public. Online disclosures are one promising solution, but evidence is needed for effective design strategies to encourage interpretation and use of information as intended.
METHOD


To examine the impact of website designs for the activation of heuristics and usability perceptions, a national probability sample of US adolescents and adults (n = 1441) was randomized in a 3 (chemical format) × 2 (webpage layout) between-subjects online experiment. Chemicals were displayed as names only, with a visual risk indicator, or with numerical ranges. Layouts displayed health harms at the top of the webpage separate from chemicals or the chemicals grouped by associated health harms. Participants viewed a webpage and reported activated heuristics, usability (perceived ease of use and usefulness), and intentions to use the website.
RESULTS


Displaying risk indicators increased website usability by encouraging users to rely on colors to interpret the risk of the chemicals (all p < .01). Website designs that grouped chemicals with harms allowed users to link the chemicals to harms they cause and increased perceived usability and intentions to use the website (all p < .001).
CONCLUSION


Assessing heuristics gives insights for how US adolescents and adults interpret chemical information and the impact of design strategies on usability. Public disclosures of chemicals in tobacco products could be optimized with color-coded risk indicators and layouts placing chemicals near the harms they cause.",2020,"Website designs that grouped chemicals with harms allowed users to link the chemicals to harms they cause and increased perceived usability and intentions to use the website (all p < .001).
",['US adolescents and adults (n = 1441'],[],['website usability'],"[{'cui': 'C0002838', 'cui_str': 'Andorra'}]",[],[],1441.0,0.0625486,"Website designs that grouped chemicals with harms allowed users to link the chemicals to harms they cause and increased perceived usability and intentions to use the website (all p < .001).
","[{'ForeName': 'Allison J', 'Initials': 'AJ', 'LastName': 'Lazard', 'Affiliation': 'School of Media and Journalism, University of North Carolina at Chapel Hill, NC 27599-3365, United States; Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, NC 27599-3365, United States. Electronic address: lazard@unc.edu.'}]",International journal of medical informatics,['10.1016/j.ijmedinf.2020.104177']
1078,32524912,Improving the Wellbeing of Female Prisoners via Psychological Skills Training: A Feasibility Study.,"Prisoners display significantly higher rates of mental disorders and lower mental wellbeing than the general population. The integration of positive psychological interventions in offender supervision has received recent advocacy. The aim of the current pre-post pilot study was to determine the short-term effects of group-based resilience training on mental health outcomes for female offenders and explore intervention acceptability. Offenders ( n  = 24) self-selected to partake in a multi-component psychological skill program based on positive psychology, cognitive-behavioural therapy, and mindfulness-based activities. The training was taught in nine sessions of 1.5 hr each. Baseline and follow-up measurements of mental wellbeing and psychological distress were collected and focus groups conducted to investigate participants' experiences, acceptability, and appropriateness of the training. Moderate to large effect sizes indicating significant improvements were observed for wellbeing,  g  = 0.75 and distress,  g  = 0.56. Training was well received by participants and staff and was delivered feasibly within the prison context. The results are encouraging, and a future well-powered study using a rigorous controlled design is warranted.",2020,Prisoners display significantly higher rates of mental disorders and lower mental wellbeing than the general population.,"['female offenders', 'Female Prisoners via Psychological Skills Training', 'Offenders ( n \u2009=\u200924) self-selected to partake in a multi-component psychological skill program based on positive psychology, cognitive-behavioural therapy, and mindfulness-based activities']",['group-based resilience training'],"['rates of mental disorders and lower mental wellbeing', 'mental health outcomes', 'mental wellbeing and psychological distress']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0699726', 'cui_str': 'Offenders'}, {'cui': 'C0033167', 'cui_str': 'Prisoners'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1510628', 'cui_str': 'Positive Psychology'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}]",,0.0242408,Prisoners display significantly higher rates of mental disorders and lower mental wellbeing than the general population.,"[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Lo', 'Affiliation': 'Wellbeing and Resilience Centre, Lifelong Health Theme, South Australian Health and Medical Research Institute, Adelaide, Australia.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Iasiello', 'Affiliation': 'Wellbeing and Resilience Centre, Lifelong Health Theme, South Australian Health and Medical Research Institute, Adelaide, Australia.'}, {'ForeName': 'Marissa', 'Initials': 'M', 'LastName': 'Carey', 'Affiliation': 'Wellbeing and Resilience Centre, Lifelong Health Theme, South Australian Health and Medical Research Institute, Adelaide, Australia.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'van Agteren', 'Affiliation': 'Wellbeing and Resilience Centre, Lifelong Health Theme, South Australian Health and Medical Research Institute, Adelaide, Australia.'}]",International journal of offender therapy and comparative criminology,['10.1177/0306624X20928029']
1079,32525416,"Effect of Hypertonic Saline during Flexible Nasopharyngeal Laryngoscopy: A Double-Blinded, Randomized, Controlled Trial.","Objectives:  Flexible nasopharyngeal laryngoscopy (NPL) is a cost-effective, simple procedure that provides visualization of the nasal airways. However, it involves a number of challenges for both the clinician and the patient. Hypertonic saline nasal wash is used to prevent nasal secretion in acute/chronic sinusitis and after nasal surgery. We aimed to determine the efficacy of hypertonic saline by comparing the clinician's and patients' experiences during NPL. Methods:  This prospective, double-blinded, randomized, controlled study was performed at a tertiary referral university hospital. Two hundred patients were randomly divided into hypertonic saline, lidocaine, xylometazoline, and isotonic saline groups. During NPL, the clinician's experiences in terms of the quality of the field of view and the patients' experiences in terms of pain and discomfort resulting from the 4 premedication drugs were compared. Results:  The groups differed significantly in terms of the clinician's field of view, and patients' pain scores and levels of discomfort ( P  < 0.025). The field of view results were the highest in the hypertonic saline group, and the lowest in the lidocaine group. The pain scores were the lowest in the lidocaine group, whereas they were the highest in the hypertonic saline group. The discomfort scores were the lowest in the xylometazoline group, but the highest in the lidocaine and isotonic saline groups. Conclusion:  The use of hypertonic saline facilitated the NPL procedure by improving the clinician's field of view. Moreover, intranasal hypertonic saline reduced the patient's discomfort. Intranasal hypertonic saline can be a good alternative to premedication before NPL.",2020,"The discomfort scores were the lowest in the xylometazoline group, but the highest in the lidocaine and isotonic saline groups.","['tertiary referral university hospital', 'acute/chronic sinusitis and after nasal surgery', 'Two hundred patients', 'Flexible Nasopharyngeal Laryngoscopy']","['hypertonic saline, lidocaine, xylometazoline, and isotonic saline', 'intranasal hypertonic saline', 'lidocaine', 'xylometazoline', 'Intranasal hypertonic saline', 'Flexible nasopharyngeal laryngoscopy (NPL', 'Hypertonic Saline', 'Hypertonic saline nasal', 'hypertonic saline']","[""clinician's field of view, and patients' pain scores and levels of discomfort"", 'pain scores', 'discomfort scores', ""patient's discomfort"", 'pain and discomfort', 'nasal secretion']","[{'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0149516', 'cui_str': 'Chronic sinusitis'}, {'cui': 'C0188970', 'cui_str': 'Operation on nose'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C0027442', 'cui_str': 'Nasopharyngeal'}, {'cui': 'C0023072', 'cui_str': 'Laryngoscopy'}]","[{'cui': 'C0036085', 'cui_str': 'sodium chloride, hypertonic'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0078643', 'cui_str': 'xylometazoline'}, {'cui': 'C0454287', 'cui_str': 'Isotonic exercise'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C0027442', 'cui_str': 'Nasopharyngeal'}, {'cui': 'C0023072', 'cui_str': 'Laryngoscopy'}, {'cui': 'C0027689', 'cui_str': 'Nepal'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}]","[{'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0036536', 'cui_str': 'secretion'}]",200.0,0.0720424,"The discomfort scores were the lowest in the xylometazoline group, but the highest in the lidocaine and isotonic saline groups.","[{'ForeName': 'Merih', 'Initials': 'M', 'LastName': 'Onal', 'Affiliation': 'Department of Otorhinolaryngology, Selcuk University, Konya, Turkey.'}, {'ForeName': 'Bahar', 'Initials': 'B', 'LastName': 'Keles', 'Affiliation': 'Department of Otorhinolaryngology, Selcuk University, Konya, Turkey.'}, {'ForeName': 'Omer', 'Initials': 'O', 'LastName': 'Erdur', 'Affiliation': 'Department of Otorhinolaryngology, Selcuk University, Konya, Turkey.'}, {'ForeName': 'Necat', 'Initials': 'N', 'LastName': 'Alatas', 'Affiliation': 'Department of Otorhinolaryngology, Konya Educational and Training Hospital, Konya, Turkey.'}, {'ForeName': 'Ozkan', 'Initials': 'O', 'LastName': 'Onal', 'Affiliation': 'Anesthesiology Institute, Department of Outcomes Research, Cleveland Clinic, Cleveland, Ohio, USA.'}]",Journal of investigative surgery : the official journal of the Academy of Surgical Research,['10.1080/08941939.2020.1777490']
1080,32529735,Re: Laparoscopic ablation or excision with helium thermal coagulator versus electrodiathermy for the treatment of mild-to-moderate endometriosis: randomised controlled trial.,,2020,,['mild-to-moderate endometriosis'],['Re: Laparoscopic ablation or excision with helium thermal coagulator versus electrodiathermy'],[],"[{'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0018880', 'cui_str': 'Helium'}]",[],,0.0688023,,"[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Hirsch', 'Affiliation': ""Institute for Women's Health, University College London, London, UK.""}, {'ForeName': 'James M N', 'Initials': 'JMN', 'LastName': 'Duffy', 'Affiliation': ""Institute for Women's Health, University College London, London, UK.""}, {'ForeName': 'Cindy M', 'Initials': 'CM', 'LastName': 'Farquhar', 'Affiliation': 'Cochrane Gynaecology and Fertility Group, Department of Obstetrics and Gynaecology, University of Auckland, Auckland, New Zealand.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16330']
1081,32529467,"A randomized, double-blind, placebo-controlled study of B-cell lymphoma 2 homology 3 mimetic gossypol combined with docetaxel and cisplatin for advanced non-small cell lung cancer with high expression of apurinic/apyrimidinic endonuclease 1.","Background Overexpression of apurinic/apyrimidinic endonuclease 1 (APE1) is an important cause of poor chemotherapeutic efficacy in advanced non-small cell lung cancer (NSCLC) patients. Gossypol, a new inhibitor of APE1, in combination with docetaxel and cisplatin is believed to improve the efficacy of chemotherapy for advanced NSCLC with high APE1 expression. Methods Sixty-two patients were randomly assigned to two groups. Thirty-one patients in the experimental group received 75 mg/m 2  docetaxel and 75 mg/m 2  cisplatin on day 1 with gossypol administered at 20 mg once daily on days 1 to 14 every 21 days. The control group received placebo with the same docetaxel and cisplatin regimen. The primary endpoint was progression-free survival (PFS); secondary endpoints included overall survival (OS), response rate, and toxicity. Results There were no significant differences in PFS and OS between the experimental group and the control group. The median PFS (mPFS) in the experimental and control groups was 7.43 and 4.9 months, respectively (HR = 0.54; p = 0.06), and the median OS (mOS) was 18.37 and 14.7 months, respectively (HR = 0.68; p = 0.27). No significant differences in response rate and serious adverse events were found between the groups. Conclusion The experimental group had a better mPFS and mOS than did the control group, though no significant difference was observed. Because the regimen of gossypol combined with docetaxel and cisplatin was well tolerated, future studies with larger sample sizes should be performed.",2020,No significant differences in response rate and serious adverse events were found between the groups.,"['Methods Sixty-two patients', 'advanced non-small cell lung cancer (NSCLC) patients', 'advanced non-small cell lung cancer with high expression of apurinic/apyrimidinic endonuclease 1']","['placebo with the same docetaxel and cisplatin regimen', 'docetaxel and cisplatin', 'docetaxel and 75 mg/m 2  cisplatin', 'gossypol combined with docetaxel and cisplatin', 'placebo']","['median PFS (mPFS', 'overall survival (OS), response rate, and toxicity', 'median OS (mOS', 'response rate and serious adverse events', 'PFS and OS', 'progression-free survival (PFS', 'mPFS and mOS']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4517835', 'cui_str': '62'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0140145', 'cui_str': 'APEX1 protein, human'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0018096', 'cui_str': 'Gossypol'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",62.0,0.138209,No significant differences in response rate and serious adverse events were found between the groups.,"[{'ForeName': 'Yuxiao', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Cancer Center, Daping Hospital & Army Medical Center of PLA, Army Medical University, 400042, Chongqing, China.'}, {'ForeName': 'Xuemei', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Cancer Center, Daping Hospital & Army Medical Center of PLA, Army Medical University, 400042, Chongqing, China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Cancer Center, Daping Hospital & Army Medical Center of PLA, Army Medical University, 400042, Chongqing, China.'}, {'ForeName': 'Mengxia', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Cancer Center, Daping Hospital & Army Medical Center of PLA, Army Medical University, 400042, Chongqing, China.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Dai', 'Affiliation': 'Cancer Center, Daping Hospital & Army Medical Center of PLA, Army Medical University, 400042, Chongqing, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Luo', 'Affiliation': 'Cancer Center, Daping Hospital & Army Medical Center of PLA, Army Medical University, 400042, Chongqing, China.'}, {'ForeName': 'Jinlu', 'Initials': 'J', 'LastName': 'Shan', 'Affiliation': 'Cancer Center, Daping Hospital & Army Medical Center of PLA, Army Medical University, 400042, Chongqing, China.'}, {'ForeName': 'Xueqin', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Cancer Center, Daping Hospital & Army Medical Center of PLA, Army Medical University, 400042, Chongqing, China.'}, {'ForeName': 'Mingfang', 'Initials': 'M', 'LastName': 'Xu', 'Affiliation': 'Cancer Center, Daping Hospital & Army Medical Center of PLA, Army Medical University, 400042, Chongqing, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Feng', 'Affiliation': 'Cancer Center, Daping Hospital & Army Medical Center of PLA, Army Medical University, 400042, Chongqing, China.'}, {'ForeName': 'Chengxiong', 'Initials': 'C', 'LastName': 'Xu', 'Affiliation': 'Cancer Center, Daping Hospital & Army Medical Center of PLA, Army Medical University, 400042, Chongqing, China.'}, {'ForeName': 'Chengyuan', 'Initials': 'C', 'LastName': 'Qian', 'Affiliation': 'Cancer Center, Daping Hospital & Army Medical Center of PLA, Army Medical University, 400042, Chongqing, China. sydqcy@hotmail.com.'}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Cancer Center, Daping Hospital & Army Medical Center of PLA, Army Medical University, 400042, Chongqing, China. dongwang64@hotmail.com.'}]",Investigational new drugs,['10.1007/s10637-020-00927-0']
1082,32470440,Longitudinal Toxicity over Time (ToxT) analysis to evaluate tolerability: a case study of lenalidomide in the CALGB 50401 (Alliance) trial.,"Evaluation of tolerability is increasingly relevant for patients with haematological malignancies treated with chronically administered therapies. Adverse events from these agents might affect the ability of patients to tolerate treatment over time. Conventional toxicity tables that include the incidence of high-grade adverse events, defined by the Common Terminology Criteria for Adverse Events, do not provide information on the time profile of these adverse events or reflect the continuous, lower grade symptomatic toxicities that are particularly relevant to treatment tolerability for patients living with indolent disease. Modern approaches to the evaluation and reporting of toxicity that capture the tolerability of treatment to the patient are imperative. In this Viewpoint, we present a focused, pilot, and longitudinal Toxicity over Time analysis of adverse events from lenalidomide and lenalidomide with rituximab in patients with follicular lymphoma treated in the CALGB 50401 (Alliance; NCT00238238) trial to define the trajectory of adverse events and quantify the burden of continuous, low-grade events. Toxicity over Time analyses provided clinically relevant descriptions of neutropenia and fatigue trajectories caused by lenalidomide that were not identified by standard analysis of the maximum grade events defined by the Common Terminology Criteria for Adverse Events. Systematic, rigorous incorporation of patient-reported outcomes in clinical trials will be crucial to our understanding of the tolerability of chronically administered therapies in patients with haematological malignancies.",2020,"Conventional toxicity tables that include the incidence of high-grade adverse events, defined by the Common Terminology Criteria for Adverse Events, do not provide information on the time profile of these adverse events or reflect the continuous, lower grade symptomatic toxicities that are particularly relevant to treatment tolerability for patients living with indolent disease.","['patients with follicular lymphoma treated in the CALGB 50401 (Alliance', 'patients with haematological malignancies', 'patients with haematological malignancies treated with chronically administered therapies', 'patients living with indolent disease']","['lenalidomide and lenalidomide with rituximab', 'lenalidomide']","['Toxicity', 'Longitudinal Toxicity over Time (ToxT) analysis to evaluate tolerability', 'grade symptomatic toxicities', 'neutropenia and fatigue trajectories']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024301', 'cui_str': 'Follicular lymphoma'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0376545', 'cui_str': 'Hematologic neoplasm'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}]","[{'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",50401.0,0.043714,"Conventional toxicity tables that include the incidence of high-grade adverse events, defined by the Common Terminology Criteria for Adverse Events, do not provide information on the time profile of these adverse events or reflect the continuous, lower grade symptomatic toxicities that are particularly relevant to treatment tolerability for patients living with indolent disease.","[{'ForeName': 'Gita', 'Initials': 'G', 'LastName': 'Thanarajasingam', 'Affiliation': 'Division of Hematology, Mayo Clinic, Rochester, MN, USA. Electronic address: thanarajasingam.gita@mayo.edu.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Leonard', 'Affiliation': 'Division of Hematology and Oncology, Department of Medicine, Weill Medical College of Cornell University, New York, NY, USA.'}, {'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Witzig', 'Affiliation': 'Division of Hematology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Habermann', 'Affiliation': 'Division of Hematology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Kristie A', 'Initials': 'KA', 'LastName': 'Blum', 'Affiliation': 'Winship Cancer Institute, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Nancy L', 'Initials': 'NL', 'LastName': 'Bartlett', 'Affiliation': 'Washington University School of Medicine, Washington University, St Louis, MO, USA.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Flowers', 'Affiliation': 'Department of Lymphoma and Myeloma, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Brandelyn N', 'Initials': 'BN', 'LastName': 'Pitcher', 'Affiliation': 'Alliance Statistics and Data Center, Duke University, Durham, NC, USA.'}, {'ForeName': 'Sin-Ho', 'Initials': 'SH', 'LastName': 'Jung', 'Affiliation': 'Alliance Statistics and Data Center, Duke University, Durham, NC, USA.'}, {'ForeName': 'Pamela J', 'Initials': 'PJ', 'LastName': 'Atherton', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Angelina', 'Initials': 'A', 'LastName': 'Tan', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Novotny', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Amylou C', 'Initials': 'AC', 'LastName': 'Dueck', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Scottsdale, AZ, USA.'}]",The Lancet. Haematology,['10.1016/S2352-3026(20)30067-3']
1083,32529588,Combination effects of diode laser and resin-modified tricalcium silicate on direct pulp capping treatment of caries exposures in permanent teeth: a randomized clinical trial.,"OBJECTIVE


The purpose of this randomized clinical trial was to evaluate efficiency of diode 808-nm (Picasso-AMD, USA) laser using power 1.5 W, continuous wave (CW), fiber diameter of 400 μm, non-initiated and in contact mode, tip angle set at 90°, beam divergence 16°, 2 s per an area with 1-mm diameter, power density 190.98 W/cm 2 , energy density 381.97 J/cm 2 , vertical and horizontal scanning movement on the exposure site, and laser irradiation combined with a resin-based tricalcium silicate material (TheraCal LC, Bisco, USA) in direct pulp capping in caries exposures of permanent teeth over a period of 6 months.
MATERIAL AND METHODS


In this randomized clinical trial, a total of 20 anterior and posterior vital teeth without symptoms and radiographic changes of 14 patients between the age group of 15-35 years, of which randomly 10 teeth were considered, each for TheraCal LC, the exposed area was sealed with TheraCal paste and TheraCal combined with diode laser; the treated area was sealed with TheraCal paste after diode 808-nm laser irradiation. At the 1-, 3-, and 6-month recall examinations, the loss of vitality, spontaneous pain, reactions to thermal stimuli and percussion, and radiographic changes were considered failure. The samples were randomly divided using runs test. Measurements on the digitized radiograph were performed at the recalls. The data were analyzed by repeated measurements ANOVA using SPSS 25.
RESULTS


Analysis had indicated that at the end of follow-ups, a statistically significant increase in dentin thickness with both groups (p value < 0.001) was found. Clinically, diode laser group has shown better results (p value < 0.001); however, radiographically, no significant difference was observed between groups (p value = 0.56). In both groups, the highest thickness of dentin formed was at the first month; 0.40 mm ± 0.19 mm (p value < 0.001).
CONCLUSION


Diode laser 808 nm under proper parameters combined with TheraCal LC can be recommended for direct pulp therapy in caries exposure of permanent teeth.
CLINICAL TRIAL REGISTRATION


This research was approved by Esfahan Medical University, Dental School, Azad Branch (KHUISF)) Esfahan, Iran [IR.IAU.KHUISF.REC.1397.261].",2020,"Clinically, diode laser group has shown better results (p value < 0.001); however, radiographically, no significant difference was observed between groups (p value = 0.56).","['Esfahan Medical University, Dental School, Azad Branch (KHUISF', 'caries exposures in permanent teeth', '20 anterior and posterior vital teeth without symptoms and radiographic changes of 14 patients between the age group of 15-35 years, of which randomly 10 teeth were considered, each for TheraCal LC, the exposed area was sealed with']","['diode laser and resin-modified tricalcium silicate', 'TheraCal paste and TheraCal combined with diode laser; the treated area was sealed with TheraCal paste after diode 808-nm laser irradiation', 'diode 808-nm (Picasso-AMD, USA) laser using power 1.5 W, continuous wave (CW), fiber diameter of 400 μm, non-initiated and in contact mode, tip angle set at 90°, beam divergence 16°, 2 s per an area with 1-mm diameter, power density 190.98 W/cm 2 , energy density 381.97 J/cm 2 , vertical and horizontal scanning movement on the exposure site, and laser irradiation combined with a resin-based tricalcium silicate material (TheraCal LC, Bisco, USA', 'diode laser', 'Diode laser 808 nm under proper parameters combined with TheraCal LC']","['dentin thickness', 'loss of vitality, spontaneous pain, reactions to thermal stimuli and percussion, and radiographic changes', 'highest thickness of dentin']","[{'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0036376', 'cui_str': 'Dental School'}, {'cui': 'C0205384', 'cui_str': 'Branching'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0348070', 'cui_str': 'Structure of permanent tooth'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0442732', 'cui_str': 'Vital'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4547168', 'cui_str': 'TheraCal'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0036492', 'cui_str': 'Seal'}]","[{'cui': 'C0392254', 'cui_str': 'Semiconductor laser device'}, {'cui': 'C0035191', 'cui_str': 'Resins, Plant'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1668343', 'cui_str': 'tricalcium silicate'}, {'cui': 'C4547168', 'cui_str': 'TheraCal'}, {'cui': 'C0030634', 'cui_str': 'Pastes'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0036492', 'cui_str': 'Seal'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0017921', 'cui_str': 'Generalized glycogenosis'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0339897', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0443204', 'cui_str': 'Divergence'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0229986', 'cui_str': 'Application site'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C1100963', 'cui_str': 'bis(terpyridine)cobalt(II) chloride'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]","[{'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C1997216', 'cui_str': 'Spontaneous pain'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0030987', 'cui_str': 'Percussion'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205250', 'cui_str': 'High'}]",10.0,0.0676895,"Clinically, diode laser group has shown better results (p value < 0.001); however, radiographically, no significant difference was observed between groups (p value = 0.56).","[{'ForeName': 'Iraj', 'Initials': 'I', 'LastName': 'Yazdanfar', 'Affiliation': 'Laser in Dentistry, RWTH University, Aachen, Germany.'}, {'ForeName': 'Mehrdad', 'Initials': 'M', 'LastName': 'Barekatain', 'Affiliation': 'Department of Restorative and Conservative Dentistry, Isfahan (Khorasgan) Branch, Islamic Azad University, Isfahan, Iran. mehrbarekat@gmail.com.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Zare Jahromi', 'Affiliation': 'Department of Endodontic, Isfahan (Khorasgan) Branch, Islamic Azad University, Isfahan, Iran.'}]",Lasers in medical science,['10.1007/s10103-020-03052-9']
1084,32527268,Neurophysiological signatures of hand motor response to dual-transcranial direct current stimulation in subacute stroke: a TMS and MEG study.,"BACKGROUND


Dual transcranial direct current stimulation (tDCS) to the bilateral primary motor cortices (M1s) has potential benefits in chronic stroke, but its effects in subacute stroke, when behavioural effects might be expected to be greater, have been relatively unexplored. Here, we examined the neurophysiological effects and the factors influencing responsiveness of dual-tDCS in subacute stroke survivors.
METHODS


We conducted a randomized sham-controlled crossover study in 18 survivors with first-ever, unilateral subcortical ischaemic stroke 2-4 weeks after stroke onset and 14 matched healthy controls. Participants had real dual-tDCS (with an ipsilesional [right for controls] M1 anode and a contralesional M1 [left for controls] cathode; 2 mA for 20mins) and sham dual-tDCS on separate days, with concurrent paretic [left for controls] hand exercise. Using transcranial magnetic stimulation (TMS) and magnetoencephalography (MEG), we recorded motor evoked potentials (MEPs), the ipsilateral silent period (iSP), short-interval intracortical inhibition, and finger movement-related cortical oscillations before and immediately after tDCS.
RESULTS


Stroke survivors had decreased excitability in ipsilesional M1 with a relatively excessive transcallosal inhibition from the contralesional to ipsilesional hemisphere at baseline compared with controls, as quantified by decreased MEPs and increased iSP duration. Dual-tDCS led to increased MEPs and decreased iSP duration in ipsilesional M1. The magnitude of the tDCS-induced MEP increase in stroke survivors was predicted by baseline contralesional-to-ipsilesional transcallosal inhibition (iSP) ratio. Baseline post-movement synchronization in α-band activity in ipsilesional M1 was decreased after stroke compared with controls, and its tDCS-induced increase correlated with upper limb score in stroke survivors. No significant adverse effects were observed during or after dual-tDCS.
CONCLUSIONS


Task-concurrent dual-tDCS in subacute stroke can safely and effectively modulate bilateral M1 excitability and inter-hemispheric imbalance and also movement-related α-activity.",2020,"Baseline post-movement synchronization in α-band activity in ipsilesional M1 was decreased after stroke compared with controls, and its tDCS-induced increase correlated with upper limb score in stroke survivors.","['subacute stroke survivors', '18 survivors with first-ever, unilateral subcortical ischaemic stroke 2-4\u2009weeks after stroke onset and 14 matched healthy controls', 'subacute stroke', 'Participants had real dual-tDCS (with an ipsilesional [right for controls] M1 anode and a contralesional M1 [left for controls] cathode; 2\u2009mA for 20mins) and']","['Dual transcranial direct current stimulation (tDCS', 'Task-concurrent dual-tDCS', 'transcranial magnetic stimulation (TMS) and magnetoencephalography (MEG', 'concurrent paretic [left for controls] hand exercise', 'dual-transcranial direct current stimulation', 'sham dual-tDCS']","['α-band activity in ipsilesional M1', 'stroke survivors', 'upper limb score', 'bilateral M1 excitability and inter-hemispheric imbalance', 'excitability in ipsilesional M1', 'adverse effects', 'motor evoked potentials (MEPs), the ipsilateral silent period (iSP), short-interval intracortical inhibition, and finger movement-related cortical oscillations', 'iSP duration']","[{'cui': 'C0205365', 'cui_str': 'Subacute'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0003103', 'cui_str': 'Anode'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0007441', 'cui_str': 'Cathode'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C0024489', 'cui_str': 'Magnetoencephalography'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0454330', 'cui_str': 'Hand exercises'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0235169', 'cui_str': 'Excitability'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0205139', 'cui_str': 'Hemispheric'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0282617', 'cui_str': 'Motor Evoked Potentials'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral'}, {'cui': 'C0443304', 'cui_str': 'Silent'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0425943', 'cui_str': 'Duration of menstrual flow'}]",18.0,0.0623601,"Baseline post-movement synchronization in α-band activity in ipsilesional M1 was decreased after stroke compared with controls, and its tDCS-induced increase correlated with upper limb score in stroke survivors.","[{'ForeName': 'I-Ju', 'Initials': 'IJ', 'LastName': 'Kuo', 'Affiliation': 'Institute of Brain Science, Brain Research Center, National Yang-Ming University, No.155, Sec. 2, Linong St., Beitou Dist, Taipei City, 112, Taiwan.'}, {'ForeName': 'Chih-Wei', 'Initials': 'CW', 'LastName': 'Tang', 'Affiliation': 'Institute of Brain Science, Brain Research Center, National Yang-Ming University, No.155, Sec. 2, Linong St., Beitou Dist, Taipei City, 112, Taiwan.'}, {'ForeName': 'Yun-An', 'Initials': 'YA', 'LastName': 'Tsai', 'Affiliation': 'Department of Neurosurgery, Taipei Veterans General Hospital, No.201, Sec. 2, Shipai Rd., Beitou Dist, Taipei City, 112, Taiwan.'}, {'ForeName': 'Shuen-Chang', 'Initials': 'SC', 'LastName': 'Tang', 'Affiliation': 'Department of Neurosurgery, Taipei Veterans General Hospital, No.201, Sec. 2, Shipai Rd., Beitou Dist, Taipei City, 112, Taiwan.'}, {'ForeName': 'Chun-Jen', 'Initials': 'CJ', 'LastName': 'Lin', 'Affiliation': 'Institute of Brain Science, Brain Research Center, National Yang-Ming University, No.155, Sec. 2, Linong St., Beitou Dist, Taipei City, 112, Taiwan.'}, {'ForeName': 'Shih-Pin', 'Initials': 'SP', 'LastName': 'Hsu', 'Affiliation': 'Institute of Brain Science, Brain Research Center, National Yang-Ming University, No.155, Sec. 2, Linong St., Beitou Dist, Taipei City, 112, Taiwan.'}, {'ForeName': 'Wei-Kuang', 'Initials': 'WK', 'LastName': 'Liang', 'Affiliation': 'Institute of Cognitive Neuroscience, National Central University, No.300, Zhongda Rd., Zhongli Dist, Taoyuan City, 320, Taiwan.'}, {'ForeName': 'Chi-Hung', 'Initials': 'CH', 'LastName': 'Juan', 'Affiliation': 'Institute of Cognitive Neuroscience, National Central University, No.300, Zhongda Rd., Zhongli Dist, Taoyuan City, 320, Taiwan.'}, {'ForeName': 'Catharina', 'Initials': 'C', 'LastName': 'Zich', 'Affiliation': 'Wellcome Centre for Integrative Neuroimaging, FMRIB, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, OX3 9DU, UK.'}, {'ForeName': 'Charlotte J', 'Initials': 'CJ', 'LastName': 'Stagg', 'Affiliation': 'Wellcome Centre for Integrative Neuroimaging, FMRIB, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, OX3 9DU, UK.'}, {'ForeName': 'I-Hui', 'Initials': 'IH', 'LastName': 'Lee', 'Affiliation': 'Institute of Brain Science, Brain Research Center, National Yang-Ming University, No.155, Sec. 2, Linong St., Beitou Dist, Taipei City, 112, Taiwan. ihlee@vghtpe.gov.tw.'}]",Journal of neuroengineering and rehabilitation,['10.1186/s12984-020-00706-1']
1085,32539150,Effect of Telehealth Extended Care for Maintenance of Weight Loss in Rural US Communities: A Randomized Clinical Trial.,"Importance


Lifestyle interventions for obesity produce reductions in body weight that can decrease risk for diabetes and cardiovascular disease but are limited by suboptimal maintenance of lost weight and inadequate dissemination in low-resource communities.
Objective


To evaluate the effectiveness of extended care programs for obesity management delivered remotely in rural communities through the US Cooperative Extension System.
Design, Setting, and Participants


This randomized clinical trial was conducted from October 21, 2013, to December 21, 2018, in Cooperative Extension Service offices of 14 counties in Florida. A total of 851 individuals were screened for participation; 220 individuals did not meet eligibility criteria, and 103 individuals declined to participate. Of 528 individuals who initiated a 4-month lifestyle intervention, 445 qualified for randomization. Data were analyzed from August 22 to October 21, 2019.
Interventions


Participants were randomly assigned to extended care delivered via individual or group telephone counseling or an education control program delivered via email. All participants received 18 modules with posttreatment recommendations for maintaining lost weight. In the telephone-based interventions, health coaches provided participants with 18 individual or group sessions focused on problem solving for obstacles to the maintenance of weight loss.
Main Outcomes and Measures


The primary outcome was change in body weight from the conclusion of initial intervention (month 4) to final follow-up (month 22). An additional outcome was the proportion of participants achieving at least 10% body weight reduction at follow-up.
Results


Among 445 participants (mean [SD] age, 55.4 [10.2] years; 368 [82.7%] women; 329 [73.9%] white), 149 participants (33.5%) were randomized to individual telephone counseling, 143 participants (32.1%) were randomized to group telephone counseling, and 153 participants (34.4%) were randomized to the email education control. Mean (SD) baseline weight was 99.9 (14.6) kg, and mean (SD) weight loss after the initial intervention was 8.3 (4.9) kg. Mean weight regains at follow-up were 2.3 (95% credible interval [CrI], 1.2-3.4) kg in the individual telephone counseling group, 2.8 (95% CrI, 1.4-4.2) kg for the group telephone counseling group, and 4.1 (95% CrI, 3.1-5.0) kg for the education control group, with a significantly smaller weight regain observed in the individual telephone counseling group vs control group (posterior probability >.99). A larger proportion of participants in the individual telephone counseling group achieved at least 10% weight reductions (31.5% [95% CrI, 24.1%-40.0%]) than in the control group (19.1% [95% CrI, 14.1%-24.9%]) (posterior probability >.99).
Conclusions and Relevance


This randomized clinical trial found that providing extended care for obesity management in rural communities via individual telephone counseling decreased weight regain and increased the proportion of participants who sustained clinically meaningful weight losses.
Trial Registration


ClinicalTrials.gov Identifier: NCT02054624.",2020,"Interventions


Participants were randomly assigned to extended care delivered via individual or group telephone counseling or an education control program delivered via email.","['851 individuals were screened for participation; 220 individuals did not meet eligibility criteria, and 103 individuals declined to participate', 'Rural US Communities', 'rural communities', 'October 21, 2013, to December 21, 2018, in Cooperative Extension Service offices of 14 counties in Florida', '445 participants (mean [SD] age, 55.4 [10.2] years; 368 [82.7%] women; 329 [73.9%] white), 149 participants (33.5', '528 individuals who initiated a 4-month lifestyle intervention, 445 qualified for randomization', ' 143 participants (32.1%) were randomized to group telephone counseling, and 153 participants (34.4']","['individual telephone counseling', 'Telehealth Extended Care', 'extended care programs', 'email education control', 'extended care delivered via individual or group telephone counseling or an education control program delivered via email']","['proportion of participants achieving at least 10% body weight reduction', 'weight regain', 'change in body weight', 'Mean (SD) baseline weight', 'weight reductions', 'Mean weight regains', 'mean (SD) weight loss']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C1136454', 'cui_str': 'Refusal to Participate'}, {'cui': 'C0086944', 'cui_str': 'Rural Communities'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0016253', 'cui_str': 'Florida'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C5191071', 'cui_str': '149'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4517573', 'cui_str': '143'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1303013', 'cui_str': 'Baseline weight'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]",851.0,0.131458,"Interventions


Participants were randomly assigned to extended care delivered via individual or group telephone counseling or an education control program delivered via email.","[{'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Perri', 'Affiliation': 'Department of Clinical and Health Psychology, University of Florida, Gainesville.'}, {'ForeName': 'Meena N', 'Initials': 'MN', 'LastName': 'Shankar', 'Affiliation': 'Department of Clinical and Health Psychology, University of Florida, Gainesville.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Daniels', 'Affiliation': 'Department of Statistics, University of Florida, Gainesville.'}, {'ForeName': 'Patricia E', 'Initials': 'PE', 'LastName': 'Durning', 'Affiliation': 'Department of Clinical and Health Psychology, University of Florida, Gainesville.'}, {'ForeName': 'Kathryn M', 'Initials': 'KM', 'LastName': 'Ross', 'Affiliation': 'Department of Clinical and Health Psychology, University of Florida, Gainesville.'}, {'ForeName': 'Marian C', 'Initials': 'MC', 'LastName': 'Limacher', 'Affiliation': 'Department of Medicine, University of Florida, Gainesville.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Janicke', 'Affiliation': 'Department of Clinical and Health Psychology, University of Florida, Gainesville.'}, {'ForeName': 'A Daniel', 'Initials': 'AD', 'LastName': 'Martin', 'Affiliation': 'Department of Physical Therapy, University of Florida, Gainesville.'}, {'ForeName': 'Kumaresh', 'Initials': 'K', 'LastName': 'Dhara', 'Affiliation': 'Department of Statistics, University of Florida, Gainesville.'}, {'ForeName': 'Linda B', 'Initials': 'LB', 'LastName': 'Bobroff', 'Affiliation': 'Department of Family, Youth, and Community Sciences, University of Florida, Gainesville.'}, {'ForeName': 'Tiffany A', 'Initials': 'TA', 'LastName': 'Radcliff', 'Affiliation': 'Department of Health Policy and Management, Texas A&M University, College Station.'}, {'ForeName': 'Christie A', 'Initials': 'CA', 'LastName': 'Befort', 'Affiliation': 'Department of Population Health, University of Kansas Medical Center, Kansas City.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.6764']
1086,32539908,An evaluation of factors influencing response to epicutaneous immunotherapy for peanut allergy in the PEPITES trial.,"Background:  Epicutaneous immunotherapy (EPIT) for peanut allergy is a potential novel immunotherapy that utilizes the unique cutaneous immunologic properties to induce desensitization. A randomized, double-blind, placebo-controlled Phase 3 trial (PEPITES) in peanut-allergic children 4-11 years demonstrated an epicutaneous patch (DBV712) with 250 µg peanut protein was statistically superior to placebo in inducing desensitization following 12 months of daily treatment.  Objective:  To investigate what baseline and in-study factors influenced response to DBV712 250 µg, with a focus on patch adhesion, by posthoc analysis of PEPITES data.  Methods:  A posthoc multivariate model built with log-transformed Month 12 eliciting dose (ED) as the dependent variable was used to assess the influence of baseline characteristics and patch adhesion. Baseline characteristics and treatment response were also evaluated by stratifying subjects into decile subgroups by patch detachment rates over the 12-month study.  Results:  Multivariate analysis identified higher baseline ED and lower baseline peanut-specific IgE as the variables most predictive of higher Month 12 ED, followed by mean daily patch application duration, baseline SCORing Atopic Dermatitis (SCORAD) score, and age. By decile stratification, no association between patch detachment and treatment response was identified for 80% of DBV712-treated subjects. All DBV712-treated subjects, including those with the highest patch detachment rates, demonstrated treatment benefit measured by fold-changes in geometric mean ED.  Conclusion:  We identified subject baseline characteristics of higher baseline ED and lower baseline peanut-specific IgE as most predictive of higher Month 12 ED. For the majority of treated subjects, patch detachment did not impact treatment response. A minority of subjects, highly sensitive to peanut at baseline, had lower prespecified responder rates and higher patch detachment rates, yet still benefited from treatment based upon fold-changes in ED.",2020,"By decile stratification, no association between patch detachment and treatment response wasidentified for 80% of DBV712-treated subjects.",['peanut-allergic children 4-11 years demonstrated an'],"['epicutaneous patch (DBV712) with 250 micrograms peanut protein', 'Epicutaneous immunotherapy (EPIT', 'epicutaneous immunotherapy', 'placebo']","['highest patch detachment rates', 'mean daily patch application duration, baseline SCORing Atopic Dermatitis(SCORAD) score, and age']","[{'cui': 'C0030736', 'cui_str': 'Arachis hypogaea'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0439211', 'cui_str': 'mcg'}, {'cui': 'C0030736', 'cui_str': 'Arachis hypogaea'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0541879', 'cui_str': 'Detachment psychological'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392707', 'cui_str': 'Atopy'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0001779', 'cui_str': 'Age'}]",,0.266158,"By decile stratification, no association between patch detachment and treatment response wasidentified for 80% of DBV712-treated subjects.","[{'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Fleischer', 'Affiliation': ""From the Children's Hospital Colorado, University of Colorado School of Medicine, Aurora, Colorado.""}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Chinthrajah', 'Affiliation': 'Sean N. Parker Center for Allergy and Asthma Research, Stanford University, Stanford, California.'}, {'ForeName': 'Amy M', 'Initials': 'AM', 'LastName': 'Scurlock', 'Affiliation': ""Department of Pediatrics, University of Arkansas for Medical Sciences and Arkansas Children's Hospital, Little Rock, Arkansas.""}, {'ForeName': 'Dianne E', 'Initials': 'DE', 'LastName': 'Campbell', 'Affiliation': ""Children's Hospital at Westmead, Sydney, Australia.""}, {'ForeName': 'Todd D', 'Initials': 'TD', 'LastName': 'Green', 'Affiliation': 'DBV Technologies, Montrouge, France.'}, {'ForeName': 'Katharine J', 'Initials': 'KJ', 'LastName': 'Bee', 'Affiliation': 'DBV Technologies, Montrouge, France.'}, {'ForeName': 'Aurélie', 'Initials': 'A', 'LastName': 'Peillon', 'Affiliation': 'DBV Technologies, Montrouge, France.'}, {'ForeName': 'Terrance', 'Initials': 'T', 'LastName': 'Ocheltree', 'Affiliation': 'Certara, Princeton, New Jersey; and.'}, {'ForeName': 'Hugh A', 'Initials': 'HA', 'LastName': 'Sampson', 'Affiliation': 'DBV Technologies, Montrouge, France.'}]",Allergy and asthma proceedings,['10.2500/aap.2020.41.200047']
1087,32533948,Corneal Topography Raw Data Classification Using a Convolutional Neural Network.,"PURPOSE


We investigated the efficiency of a convolutional neural network applied to corneal topography raw data to classify examinations of 3 categories: normal, keratoconus (KC), and history of refractive surgery (RS).
DESIGN


Retrospective machine-learning experimental study.
METHODS


A total of 3,000 Orbscan examinations (1,000 of each class) of different patients of our institution were selected for model training and validation. One hundred examinations of each class were randomly assigned to the test set. For each examination, the raw numerical data from ""elevation against the anterior best fit sphere (BFS),"" ""elevation against the posterior BFS"" ""axial anterior curvature,"" and ""pachymetry"" maps were used. Each map was a square matrix of 2,500 values. The 4 maps were stacked and used as if they were 4 channels of a single image.A convolutional neural network was built and trained on the training set. Classification accuracy and class wise sensitivity and specificity were calculated for the validation set.
RESULTS


Overall classification accuracy of the validation set (n = 300) was 99.3% (98.3%-100%). Sensitivity and specificity were, respectively, 100% and 100% for KC, 100% and 99% (94.9%-100%) for normal examinations, and 98% (97.4%-100%) and 100% for RS examinations.
CONCLUSION


Using combined corneal topography raw data with a convolutional neural network is an effective way to classify examinations and probably the most thorough way to automatically analyze corneal topography. It should be considered for other routine tasks performed on corneal topography, such as refractive surgery screening.",2020,Overall classification accuracy of the validation set (n = 300) was 99.3% (98.3%-100%):.,"['3,000 Orbscan examinations (1000 of each class) of different patients of our institution were selected for model training and validation', '100 examinations of each class']",[],"['Classification accuracy and class wise sensitivity and specificity', 'Sensitivity and specificity']","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1704407', 'cui_str': '100'}]",[],"[{'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0036668', 'cui_str': 'Sensitivity and Specificity'}]",,0.0443956,Overall classification accuracy of the validation set (n = 300) was 99.3% (98.3%-100%):.,"[{'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Zéboulon', 'Affiliation': 'Department of Ophthalmology, Rothschild Foundation, Paris, France. Electronic address: pierrezeboulon@gmail.com.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Debellemanière', 'Affiliation': 'Department of Ophthalmology, Rothschild Foundation, Paris, France.'}, {'ForeName': 'Magalie', 'Initials': 'M', 'LastName': 'Bouvet', 'Affiliation': 'Department of Ophthalmology, Rothschild Foundation, Paris, France.'}, {'ForeName': 'Damien', 'Initials': 'D', 'LastName': 'Gatinel', 'Affiliation': 'Department of Ophthalmology, Rothschild Foundation, Paris, France; CEROC (Center of Expertise and Research in Optics for Clinicians), Paris, France.'}]",American journal of ophthalmology,['10.1016/j.ajo.2020.06.005']
1088,32533949,Omidenepag Isopropyl Versus Latanoprost in Primary Open-Angle Glaucoma and Ocular Hypertension: The Phase 3 AYAME Study.,"PURPOSE


To evaluate the efficacy and safety of omidenepag isopropyl (OMDI), a selective, non-prostaglandin, prostanoid EP2 receptor agonist, in Japanese patients with primary open-angle glaucoma (POAG) or ocular hypertension (OHT).
DESIGN


Phase III, randomized, investigator-masked, active-controlled, parallel-group, noninferiority study (ClinicalTrials.govNCT02623738).
METHODS


After a washout period of 1-4 weeks, eligible patients were randomized (1:1) to OMDI 0.002% or latanoprost 0.005% once daily for 4 weeks. Intraocular pressure (IOP) was measured at 9:00 AM, 1:00 PM, and 5:00 PM at weeks 1, 2, and 4. The primary endpoint was the change from baseline in mean diurnal IOP at week 4. The noninferiority margin for OMDI versus latanoprost was 1.5 mm Hg. Adverse events (AEs) were recorded.
RESULTS


Of the 190 patients randomized, 189 had at least 1 post-baseline IOP measurement. At baseline, patients who received OMDI or latanoprost had a mean ± SD diurnal IOP of 23.78 ± 1.73 mm Hg and 23.40 ± 1.51 mm Hg, respectively. At week 4, least-squares mean ± SE reduction in IOP from baseline with OMDI (-5.93 ± 0.23 mm Hg) was noninferior to that of latanoprost (-6.56 ± 0.22 mm Hg; 95% confidence interval between groups: 0.01-1.26). The most frequently reported treatment-related ocular AEs (OMDI vs latanoprost) were conjunctival hyperemia (23/94 patients [24.5%] vs 10/96 patients [10.4%]), corneal thickening (11/94 patients [11.7%] vs 1/96 patients [1.0%]), and punctate keratitis (0/94 patients vs 5/96 patients [5.2%]). No serious AEs were observed in either group, and there were no discontinuations related to the study drug.
CONCLUSIONS


OMDI 0.002% was noninferior to latanoprost 0.005% in reducing IOP in patients with OHT or POAG and was well tolerated.",2020,The most frequently reported treatment-related ocular AEs (OMDI versus latanoprost) were conjunctival hyperemia (,"['190 patients randomized, 189 had at least 1 post-baseline IOP measurement', 'Primary Open-angle Glaucoma and Ocular Hypertension', 'Japanese patients with primary open-angle glaucoma (POAG) or ocular hypertension (OHT']","['Omidenepag Isopropyl Versus Latanoprost', 'omidenepag isopropyl (OMDI', 'OMDI or latanoprost', 'OMDI 0.002% or latanoprost', 'latanoprost']","['mean diurnal IOP', 'conjunctival hyperemia ', 'serious AEs', 'corneal thickening', 'tolerated', 'punctate keratitis', 'mean diurnal IOP (±SD', 'Adverse events (AEs', 'Intraocular pressure (IOP']","[{'cui': 'C4517622', 'cui_str': '190'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0040420', 'cui_str': 'Tonometry'}, {'cui': 'C0339573', 'cui_str': 'Primary open angle glaucoma'}, {'cui': 'C0028840', 'cui_str': 'Ocular hypertension'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}]","[{'cui': 'C5139819', 'cui_str': 'omidenepag isopropyl'}, {'cui': 'C0090306', 'cui_str': 'latanoprost'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C1761613', 'cui_str': 'Conjunctival hyperemia'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3160915', 'cui_str': 'Corneal thickening'}, {'cui': 'C0259799', 'cui_str': 'Superficial punctate keratitis'}]",190.0,0.21222,The most frequently reported treatment-related ocular AEs (OMDI versus latanoprost) were conjunctival hyperemia (,"[{'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Aihara', 'Affiliation': 'Department of Ophthalmology, University of Tokyo, Bunkyo-ku, Tokyo, Japan.'}, {'ForeName': 'Fenghe', 'Initials': 'F', 'LastName': 'Lu', 'Affiliation': 'Santen Inc., Emeryville, California, USA. Electronic address: fenghe_lu@hotmail.com.'}, {'ForeName': 'Hisashi', 'Initials': 'H', 'LastName': 'Kawata', 'Affiliation': 'Santen Pharmaceutical Co. Ltd., Osaka, Japan.'}, {'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Iwata', 'Affiliation': 'Santen Inc., Emeryville, California, USA; Santen Pharmaceutical Co. Ltd., Osaka, Japan.'}, {'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Odani-Kawabata', 'Affiliation': 'Santen Inc., Emeryville, California, USA; Santen Pharmaceutical Co. Ltd., Osaka, Japan.'}, {'ForeName': 'Naveed K', 'Initials': 'NK', 'LastName': 'Shams', 'Affiliation': 'Santen Inc., Emeryville, California, USA; Santen Pharmaceutical Co. Ltd., Osaka, Japan.'}]",American journal of ophthalmology,['10.1016/j.ajo.2020.06.003']
1089,32539812,Effects of transcranial direct current stimulation with virtual reality on upper limb function in patients with ischemic stroke: a randomized controlled trial.,"BACKGROUND


Non-invasive brain stimulation techniques have been shown in several studies to improve the motor recovery of the affected upper-limbs in stroke patients. This study aims to investigate whether or not cathodal transcranial direct current stimulation (c-tDCS), combined with virtual reality (VR), is superior to VR alone in reducing motor impairment and improving upper limb function and quality of life in stroke patients.
METHODS


Forty patients who suffered ischemic stroke between 2 weeks to 12 months were recruited for this single-blind randomized control trial. The patients were randomly assigned either to an experimental group who receiving c-tDCS and VR, or a control group receiving sham stimulation and VR. The cathodal electrode was positioned over the primary motor cortex (M1) of the unaffected hemisphere. The treatment session consisted of 20 min of daily therapy, for 10 sessions over a 2-week period. The outcome measures were the Fugl-Meyer Upper Extremity (FM-UE), the Action Research Arm Test (ARAT) and the Barthel Index (BI).
RESULTS


The two groups were comparable in demographic characteristic and motor impairment. After 2 weeks of intervention, both groups demonstrated significant improvement in FM-UE, ARAT and BI scores (P<0.05).The experiment group demonstrated more improvement in FM-UE than the control group (10.1 vs. 6.4, p = 0.003) and, ARAT (7.0 vs 3.6, p = 0.026) and BI (12.8 vs 8.5, p = 0.043).
CONCLUSIONS


The findings from our study support that c-tDCS, along with VR, can facilitate a stronger beneficial effect on upper limb motor impairment, function and quality of life than VR alone in patients with ischemic stroke.
TRIAL REGISTRATION


The study was registered in the Chinese Clinical Trial Registry (ChiCTR1800019386) in November 8, 2018-Retrospectively registered.",2020,"After 2 weeks of intervention, both groups demonstrated significant improvement in FM-UE, ARAT and BI scores (P<0.05).The experiment group demonstrated more improvement in FM-UE than the control group (10.1 vs. 6.4, p = 0.003) and, ARAT (7.0 vs 3.6, p = 0.026) and BI (12.8 vs 8.5, p = 0.043).
","['stroke patients', 'patients with ischemic stroke', 'Forty patients who suffered ischemic stroke between 2\u2009weeks to 12\u2009months']","['cathodal transcranial direct current stimulation (c-tDCS), combined with virtual reality (VR', 'experimental group who receiving c-tDCS and VR, or a control group receiving sham stimulation and VR', 'transcranial direct current stimulation with virtual reality']","['ARAT', 'FM-UE', 'demographic characteristic and motor impairment', 'FM-UE, ARAT and BI scores', 'upper limb motor impairment, function and quality of life', 'Fugl-Meyer Upper Extremity (FM-UE), the Action Research Arm Test (ARAT) and the Barthel Index (BI', 'motor impairment and improving upper limb function and quality of life']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C4720875', 'cui_str': 'Action research arm test'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",40.0,0.105452,"After 2 weeks of intervention, both groups demonstrated significant improvement in FM-UE, ARAT and BI scores (P<0.05).The experiment group demonstrated more improvement in FM-UE than the control group (10.1 vs. 6.4, p = 0.003) and, ARAT (7.0 vs 3.6, p = 0.026) and BI (12.8 vs 8.5, p = 0.043).
","[{'ForeName': 'Xiaoling', 'Initials': 'X', 'LastName': 'Yao', 'Affiliation': 'Department of Rehabilitation Medicine, Ruijin Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Lijun', 'Initials': 'L', 'LastName': 'Cui', 'Affiliation': 'Department of Rehabilitation Medicine, Ruijin Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Jixian', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Rehabilitation Medicine, Ruijin Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Wuwei', 'Initials': 'W', 'LastName': 'Feng', 'Affiliation': 'Deparment of Neurology, Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Bao', 'Affiliation': 'Department of Rehabilitation Medicine, Shanghai Ruijin Rehabilitation Hospital, Shanghai, China. 15901999958@163.com.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Xie', 'Affiliation': 'Department of Rehabilitation Medicine, Ruijin Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China. ruijin_xq@163.com.'}]",Journal of neuroengineering and rehabilitation,['10.1186/s12984-020-00699-x']
1090,32540842,One Drop App With an Activity Tracker for Adults With Type 1 Diabetes: Randomized Controlled Trial.,"BACKGROUND


In 2017, mobile app support for managing diabetes was available to 64% of the global population of adults with diabetes. One Drop's digital therapeutics solution includes an evidence-based mobile app with global reach, a Bluetooth-connected glucometer, and in-app coaching from Certified Diabetes Educators. Among people with type 1 diabetes and an estimated hemoglobin A 1c  level≥7.5%, using One Drop for 3 months has been associated with an improved estimated hemoglobin A 1c  level of 22.2 mg/dL (-0.80%). However, the added value of integrated activity trackers is unknown.
OBJECTIVE


We conducted a pragmatic, remotely administered randomized controlled trial to evaluate One Drop with a new-to-market activity tracker against One Drop only on the 3-month hemoglobin A 1c  level of adults with type 1 diabetes.
METHODS


Social media advertisements and online newsletters were used to recruit adults (≥18 years old) diagnosed (≥1 year) with T1D, naïve to One Drop's full solution and the activity tracker, with a laboratory hemoglobin A 1c  level≥7%. Participants (N=99) were randomized to receive One Drop and the activity tracker or One Drop only at the start of the study. The One Drop only group received the activity tracker at the end of the study. Multiple imputation, performed separately by group, was used to correct for missing data. Analysis of covariance models, controlling for baseline hemoglobin A 1c , were used to evaluate 3-month hemoglobin A 1c  differences in intent-to-treat (ITT) and per protocol (PP) analyses.
RESULTS


The enrolled sample (N=95) had a mean age of 41 (SD 11) years, was 73% female, 88% White, diagnosed for a mean of 20 (SD 11) years, and had a mean hemoglobin A 1c  level of 8.4% (SD 1.2%); 11% of the participants did not complete follow up. Analysis of covariance assumptions were met for the ITT and PP models. In ITT analysis, participants in the One Drop and activity tracker condition had a significantly lower 3-month hemoglobin A 1c  level (mean 7.9%, SD 0.60%, 95% CI 7.8-8.2) than that of the participants in the One Drop only condition (mean 8.4%, SD 0.62%, 95% CI 8.2-8.5). In PP analysis, participants in the One Drop and activity tracker condition also had a significantly lower 3-month hemoglobin A 1c  level (mean 7.9%, SD 0.59%, 95% CI 7.7-8.1) than that of participants in the One Drop only condition (mean 8.2%, SD 0.58%, 95% CI 8.0-8.4).
CONCLUSIONS


Participants exposed to One Drop and the activity tracker for the 3-month study period had a significantly lower 3-month hemoglobin A 1c  level compared to that of participants exposed to One Drop only during the same timeframe. One Drop and a tracker may work better together than alone in helping people with type 1 diabetes.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03459573; https://clinicaltrials.gov/ct2/show/NCT03459573.",2020,"In ITT, participants with OD + tracker had a significantly lower three-month A1c (7.9% [95% CI 7.8 - 8.2]  .60%) than did participants with OD only (8.4% [95% CI 8.2 - 8.5]  .62%).","['Participants (N = 99', ""adults with T1D.\nMETHODS\n\n\nSocial media advertisements and online newsletters recruited adults (≥ 18 years old) diagnosed (≥ 1 year) with T1D, naïve to OD's full solution and the activity tracker with lab A1c ≥ 7"", 'The enrolled sample (n = 95) was 41 ± 11 years old, 73% female, 88% White, diagnosed for 20 ± 11 years with a mean A1c of 8.4% ± 1.2', 'Adults with Type 1 Diabetes']","['OD plus activity tracker', 'new-to-market activity tracker', 'Activity Tracker']",[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0027988', 'cui_str': 'Newsletters'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C4264352', 'cui_str': 'Activity Trackers'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517876', 'cui_str': '8.4'}, {'cui': 'C4068880', 'cui_str': '1.2'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4264352', 'cui_str': 'Activity Trackers'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C1318228', 'cui_str': 'Market'}]",[],99.0,0.0789327,"In ITT, participants with OD + tracker had a significantly lower three-month A1c (7.9% [95% CI 7.8 - 8.2]  .60%) than did participants with OD only (8.4% [95% CI 8.2 - 8.5]  .62%).","[{'ForeName': 'Chandra Y', 'Initials': 'CY', 'LastName': 'Osborn', 'Affiliation': 'Informed Data Systems Inc, New York, NY, United States.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Hirsch', 'Affiliation': 'Informed Data Systems Inc, New York, NY, United States.'}, {'ForeName': 'Lindsay E', 'Initials': 'LE', 'LastName': 'Sears', 'Affiliation': 'Informed Data Systems Inc, New York, NY, United States.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Heyman', 'Affiliation': 'Informed Data Systems Inc, New York, NY, United States.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Raymond', 'Affiliation': 'Division of Endocrinology, Department of Pediatrics, University of Southern California, Los Angeles, CA, United States.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Huddleston', 'Affiliation': 'Informed Data Systems Inc, New York, NY, United States.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Dachis', 'Affiliation': 'Informed Data Systems Inc, New York, NY, United States.'}]",JMIR mHealth and uHealth,['10.2196/16745']
1091,32532700,The Hunger Games: Laparoscopic Performance in Novice Surgeons is Not Altered by Food Deprivation but Influenced by the Degree of Appetite - A Randomized Controlled Trial.,"OBJECTIVES


Food deprivation is a common condition for visceral surgeons and especially laparoscopic approaches require high levels of concentration. The current literature does not provide adequate answers whether intraoperative breaks, especially food intake, might influence the quality of the surgical skills. Thus, the primary aim of this trial was to analyze the influence of food deprivation on the laparoscopic performance.
DESIGN SETTING AND PARTICIPANTS


37 laparoscopic novices participated from 10/2017 to 04/2018 in this single center, prospective-randomized trial and were trained during laparoscopic training sessions until they reached a predefined level of proficiency. Subsequently, participants were randomized into 3 different groups: food deprivation of 8 hours, 4 hours, or carbohydrate loading directly prior to the laparoscopic exam. The exam comprised PEG-transfer, precise cutting, gallbladder resection and surgical knot.
MAIN FINDINGS


Completion time for PEG-transfer, precise cutting, gallbladder resection and surgical knot was 63s, 139s, 192s and 272s respectively. Participants starving for 8 hours performed 3 of 4 tasks more slowly whilst participants starving for 4 hours performed 3 of 4 tasks faster than the average. Analyzing self-reported level of appetite revealed: Students with an intermediate level were significantly faster (p <0.05) during complex procedures compared to participants that reported hunger prior to performing these tasks (192s vs. 307s). Additionally, hungry students had been more inaccurate during the surgical knot (p <0.05) whilst students with intermediate appetite level tend to be most accurate (p - value 0.012).
CONCLUSIONS


The subjective level of appetite rather than the absolute number of fasting hours influences the laparoscopic performance most. Thus, any extreme level of appetite may be avoided and surgeons may achieve the best performance when they have an intermediate level of appetite. In consequence, heavy meals may be omitted immediately prior to demanding laparoscopic procedures and surgeons may have access to mini-breaks and refreshers during major procedures.",2020,Analyzing self-reported level of appetite revealed: Students with an intermediate level were significantly faster (p <0.05) during complex procedures compared to participants that reported hunger prior to performing these tasks (192s vs. 307s).,['37 laparoscopic novices participated from 10/2017 to 04/2018 in this single center'],"['laparoscopic training sessions', 'food deprivation of 8 hours, 4 hours, or carbohydrate loading directly prior to the laparoscopic exam']","['Completion time for PEG-transfer, precise cutting, gallbladder resection and surgical knot']","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0016464', 'cui_str': 'Food Deprivation'}, {'cui': 'C1292429', 'cui_str': '8 hours'}, {'cui': 'C1292426', 'cui_str': '4 hours'}, {'cui': 'C4277655', 'cui_str': 'Carbohydrate Loading Diet'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0582103', 'cui_str': 'Medical assessment'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0032478', 'cui_str': 'Polyethylene Glycol 400'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0016976', 'cui_str': 'Gallbladder structure'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0560032', 'cui_str': 'knot'}]",37.0,0.0776599,Analyzing self-reported level of appetite revealed: Students with an intermediate level were significantly faster (p <0.05) during complex procedures compared to participants that reported hunger prior to performing these tasks (192s vs. 307s).,"[{'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Bechtolsheim', 'Affiliation': 'Department for Visceral, Thoracic and Vascular Surgery, University Hospital Dresden, Dresden, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Oehme', 'Affiliation': 'Department for Visceral, Thoracic and Vascular Surgery, University Hospital Dresden, Dresden, Germany.'}, {'ForeName': 'Juergen', 'Initials': 'J', 'LastName': 'Weitz', 'Affiliation': 'Department for Visceral, Thoracic and Vascular Surgery, University Hospital Dresden, Dresden, Germany.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Oppermann', 'Affiliation': 'Department for Visceral, Thoracic and Vascular Surgery, University Hospital Dresden, Dresden, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Reissfelder', 'Affiliation': 'Department for Visceral, Thoracic and Vascular Surgery, University Hospital Dresden, Dresden, Germany; Department of Surgery, University Mannheim, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany.'}, {'ForeName': 'Soeren T', 'Initials': 'ST', 'LastName': 'Mees', 'Affiliation': 'Department for Visceral, Thoracic and Vascular Surgery, University Hospital Dresden, Dresden, Germany; Department of General, Visceral, and Thoracic Surgery, Municipal Hospital Dresden-Friedrichstadt, Dresden, Germany.'}, {'ForeName': 'Cui', 'Initials': 'C', 'LastName': 'Yang', 'Affiliation': 'Department for Visceral, Thoracic and Vascular Surgery, University Hospital Dresden, Dresden, Germany; Department of Surgery, University Mannheim, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany. Electronic address: cui.yang@umm.de.'}]",Journal of surgical education,['10.1016/j.jsurg.2020.03.029']
1092,32538796,Usability of a Consumer Health Informatics Tool Following Completion of a Clinical Trial: Focus Group Study.,"BACKGROUND


Mobile health (mHealth) apps have the potential to be effective tools for encouraging patients with chronic diseases to self-manage their health. The success of mHealth apps is related to technology acceptance and its subsequent use by intended consumers. Therefore, it is essential to gain insights from consumers' perspectives about their use of mHealth apps in daily life.
OBJECTIVE


The purpose of this work was to understand consumers' perspectives on use of a self-management app following completion of a clinical trial that tested the efficacy of the app for improving health outcomes.
METHODS


We conducted five focus groups with paricipants of a clinical trial (NCT03182738) who were randomized to use the video information provider (VIP) for HIV-associated nonAIDS (HANA) conditions app (VIP-HANA) or an attention control app. Thematic analysis was conducted, and the themes were organized according to the two key constructs of the technology acceptance model framework: perceived usefulness and perceived ease of use.
RESULTS


Thirty-nine people living with HIV (20 from the intervention group and 19 from the control group) participated in the focus group sessions. Of the eight themes identified from focus group data, the five themes related to perceived usefulness were: (1) self-monitoring HIV-related symptoms of HANA conditions, (2) enhanced relationship with clinical providers, (3) improvement in physical and emotional health, (4) long-term impact of self-care strategies on improvement in symptoms of HANA conditions, and (5) inspired lifestyle changes to manage symptoms. The three themes related to perceived ease of use were: (1) easy to navigate, (2) avatar personalization, and (3) privacy/confidentiality maintained even when changing the location of app use.
CONCLUSIONS


Perceived ease of use was similar in both study groups but perceived usefulness differed between study groups. Participants in both study groups found the VIP-HANA app to be useful in monitoring their symptoms and enhancing communication with their clinical care providers. However, only intervention group participants perceived the app to be useful in improving overall health and long-term symptom management. Findings from this study highlight factors that are essential to ensure the usefulness of self-management apps and facilitate sustained use of mHealth apps for people living with chronic illnesses.",2020,Participants in both study groups found the VIP-HANA app to be useful in monitoring their symptoms and enhancing communication with their clinical care providers.,"['patients with chronic diseases to self-manage their health', 'people living with chronic illnesses', 'Thirty-nine people living with HIV (20 from the intervention group and 19 from the control group) participated in the focus group sessions']",['video information provider (VIP) for HIV-associated nonAIDS (HANA) conditions app (VIP-HANA) or an attention control app'],"['self-monitoring HIV-related symptoms of HANA conditions, (2) enhanced relationship with clinical providers, (3) improvement in physical and emotional health, (4) long-term impact of self-care strategies on improvement in symptoms of HANA conditions, and (5) inspired lifestyle changes to manage symptoms', 'overall health and long-term symptom management']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C3816447', 'cui_str': '39'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0016400', 'cui_str': 'Focus Groups'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}]",39.0,0.0429502,Participants in both study groups found the VIP-HANA app to be useful in monitoring their symptoms and enhancing communication with their clinical care providers.,"[{'ForeName': 'Hwayoung', 'Initials': 'H', 'LastName': 'Cho', 'Affiliation': 'College of Nursing, University of Florida, Gainesville, FL, United States.'}, {'ForeName': 'Tiffany', 'Initials': 'T', 'LastName': 'Porras', 'Affiliation': 'School of Nursing, Columbia University, New York, NY, United States.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Flynn', 'Affiliation': 'School of Nursing, Columbia University, New York, NY, United States.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Schnall', 'Affiliation': 'School of Nursing, Columbia University, New York, NY, United States.'}]",Journal of medical Internet research,['10.2196/17708']
1093,32527676,Virtual reality based cognitive behavioral therapy for paranoia: Effects on mental states and the dynamics among them.,"BACKGROUND


Negative affective processes may contribute to maintenance of paranoia in patients with psychosis, and vice versa. Successful treatment may break these pathological symptom networks. This study examined whether treatment with virtual reality based cognitive behavioral therapy (VR-CBT) for paranoia influences momentary affective states, and whether VR-CBT changes the adverse interplay between affective states and paranoia.
METHODS


Patients with a psychotic disorder (n = 91) were randomized to 16-session VR-CBT or treatment as usual (TAU). With the experience sampling method (structured diary technique) mental states were assessed for 6-10 days at baseline, posttreatment and 6-month follow-up. Multilevel analysis were performed to establish treatment effects and time-lagged associations between mental states, that were visualized with networks of mental states.
RESULTS


Average levels of paranoia (feeling suspicious [b = -032., p = .04], disliked [b = -49., p < .01] and hurt [b = -0.52, p < .01]) and negative affect (anxious [b = -0.37, p = .01], down [b = -0.33, p = .04] and insecure [b = -0.17, p = .03) improved more after VR-CBT than TAU, but positive affect did not. Baseline mental state networks had few significant connections, with most stable connections being autocorrelations of mental states. The interplay between affective states and paranoia did not change in response to treatment. A trend reduction in average intranode connections (autocorrelations) was found after VR-CBT (b = -0.07, p = .08), indicating that mental states reinforce themselves less after treatment.
CONCLUSIONS


VR-CBT reduced paranoid symptoms and lowered levels of negative affect in daily life, but did not affect the extent to which mental states influenced each other. Findings do suggest that as a result of treatment mental states regain flexibility.",2020,"VR-CBT reduced paranoid symptoms and lowered levels of negative affect in daily life, but did not affect the extent to which mental states influenced each other.","['patients with psychosis, and vice versa', 'paranoia', 'Patients with a psychotic disorder (n\u202f=\u202f91']","['16-session VR-CBT or treatment as usual (TAU', 'Virtual reality based cognitive behavioral therapy', 'virtual reality based cognitive behavioral therapy (VR-CBT']","['average intranode connections (autocorrelations', 'paranoid symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C1456784', 'cui_str': 'Paranoid disorder'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0449379', 'cui_str': 'Connection'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",91.0,0.025786,"VR-CBT reduced paranoid symptoms and lowered levels of negative affect in daily life, but did not affect the extent to which mental states influenced each other.","[{'ForeName': 'Chris N W', 'Initials': 'CNW', 'LastName': 'Geraets', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Department of Psychiatry, the Netherlands. Electronic address: c.n.w.geraets@umcg.nl.'}, {'ForeName': 'Evelien', 'Initials': 'E', 'LastName': 'Snippe', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Department of Psychiatry, Interdisciplinary Center Psychopathology and Emotion regulation (ICPE), the Netherlands.'}, {'ForeName': 'Marije', 'Initials': 'M', 'LastName': 'van Beilen', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Department of Psychiatry, the Netherlands.'}, {'ForeName': 'Roos M C A', 'Initials': 'RMCA', 'LastName': 'Pot-Kolder', 'Affiliation': 'Parnassia Psychiatric Institute, The Hague, the Netherlands; VU University and Amsterdam Public Mental Health research institute, Department of Clinical Psychology, Amsterdam, the Netherlands.'}, {'ForeName': 'Marieke', 'Initials': 'M', 'LastName': 'Wichers', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Department of Psychiatry, Interdisciplinary Center Psychopathology and Emotion regulation (ICPE), the Netherlands.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'van der Gaag', 'Affiliation': 'Parnassia Psychiatric Institute, The Hague, the Netherlands; VU University and Amsterdam Public Mental Health research institute, Department of Clinical Psychology, Amsterdam, the Netherlands.'}, {'ForeName': 'Wim', 'Initials': 'W', 'LastName': 'Veling', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Department of Psychiatry, the Netherlands; Parnassia Psychiatric Institute, The Hague, the Netherlands; Maastricht University, Department of Psychiatry and Neuropsychology, Maastricht, the Netherlands.'}]",Schizophrenia research,['10.1016/j.schres.2020.05.047']
1094,32534376,Fatty acid desaturation in red blood cell membranes of patients with type 2 diabetes is improved by zinc supplementation.,"BACKGROUND/OBJECTIVE


Membrane flexibility can be a determining factor in pathophysiological mechanisms of type 2 diabetes (T2D). As a cofactor of delta-5 desaturase (D5D) and delta-6 desaturase (D6D), and gene expression regulator, zinc may play a role modulating membrane flexibility by increasing membrane polyunsaturated fatty acids (PUFA) abundance. The objective of this study was to evaluate the effect of a 24-month zinc supplementation (30 mg elemental zinc) on membrane fatty acid composition in patients with T2D.
SUBJECTS/METHODS


Sixty patients with T2D were evaluated. Thirty were randomly assigned to the zinc supplemented group and thirty to the placebo group. Fatty acid composition in red blood cell (RBC) membranes was determined by gas chromatography. Expression of gene encoding for D5D (FADS1), and D6D (FADS2) were evaluated in peripheral blood mononuclear cells by real-time polymerase chain reaction.
RESULTS


After 24 months of supplementation, a greater abundance of docosapentaenoic acid (C22:5 n-3), arachidonic acid (C20:4 n-6), adrenic acid (C22:4 n-6), and total n-6 PUFA was found (p = 0.001, p = 0.007, p = 0.033, p = 0.048, respectively). The unsaturated fatty acids/saturated fatty acids ratio, and unsaturation index was increased in the zinc supplemented group at month 24 (p = 0.003 and p  = 0.000, respectively). FADS1 gene was upregulated in the zinc group in relation to placebo at month 12 (p = 0.020).
CONCLUSIONS


Supplementation with 30 mg/d elemental zinc during 24 months in patients with T2D had an effect on the composition of RBC membranes increasing PUFA abundance and in turn, improving membrane flexibility. This effect may be mediated by induction of D5D gene expression.",2020,"FADS1 gene was upregulated in the zinc group in relation to placebo at month 12 (p = 0.020).
","['patients with T2D', 'Sixty patients with T2D were evaluated', 'patients with type 2 diabetes']","['Fatty acid desaturation', 'zinc supplementation (30\u202fmg elemental zinc', 'placebo']","['membrane flexibility', 'Expression of gene encoding for D5D (FADS1), and D6D (FADS2', 'Fatty acid composition in red blood cell (RBC) membranes', 'abundance of docosapentaenoic acid (C22:5 n-3), arachidonic acid (C20:4 n-6), adrenic acid (C22:4 n-6), and total n-6 PUFA', 'FADS1 gene', 'unsaturated fatty acids/saturated fatty acids ratio, and unsaturation index', 'membrane fatty acid composition']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}, {'cui': 'C4524022', 'cui_str': 'Zinc supplementation'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0057338', 'cui_str': 'delta-5 fatty acid desaturase'}, {'cui': 'C0065017', 'cui_str': 'Linoleoyl-CoA desaturase'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0058624', 'cui_str': 'docosapentaenoic acid'}, {'cui': 'C0003695', 'cui_str': 'Arachidonic acid'}, {'cui': 'C0050877', 'cui_str': 'adrenic acid'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1276035', 'cui_str': 'Pena-Shokeir syndrome type I'}, {'cui': 'C0015690', 'cui_str': 'Unsaturated fatty acid'}, {'cui': 'C0597423', 'cui_str': 'Saturated fat'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",60.0,0.126956,"FADS1 gene was upregulated in the zinc group in relation to placebo at month 12 (p = 0.020).
","[{'ForeName': 'María Catalina', 'Initials': 'MC', 'LastName': 'Hernández', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Rojas', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Carrasco', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Basfi-Fer', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Valenzuela', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Juana', 'Initials': 'J', 'LastName': 'Codoceo', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Inostroza', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Ruz', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile. Electronic address: mruz@med.uchile.cl.'}]",Journal of trace elements in medicine and biology : organ of the Society for Minerals and Trace Elements (GMS),['10.1016/j.jtemb.2020.126571']
1095,32539655,Effects of a high-intensity psychosocial intervention among child-parent units in pediatric oncology.,"AIM


To compare the efficacy of a high-intensity psychosocial intervention with standardized usual care in countering psychosocial complexity among child-parent units in a pediatric oncology setting.
METHODS


Two hundred pediatric oncology patients and their parents were recruited from Italian hospitals. A total of 81 child-parent units were assigned to the high-intensity psychosocial intervention and 119 child-parent units to standardized usual care. Psychosocial factors were assessed before and 1 year after intervention to measure efficacy.
RESULTS


More improvements over time were observed in the high-intensity intervention group of child-parent units compared to the standard intervention group.
CONCLUSION


An intensive, structured, and tailored high-intensity intervention positively affects the psychosocial factors of child-parent units. Patients and families should have access to intensive psychosocial support throughout the cancer trajectory.",2020,"RESULTS


More improvements over time were observed in the high-intensity intervention group of child-parent units compared to the standard intervention group.
","['81 child-parent units', 'child-parent units in pediatric oncology', 'Two hundred pediatric oncology patients and their parents were recruited from Italian hospitals', 'child-parent units in a pediatric oncology setting']","['high-intensity psychosocial intervention', 'high-intensity psychosocial intervention with standardized usual care', 'high-intensity psychosocial intervention and 119 child-parent units to standardized usual care']",['Psychosocial factors'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C1518931', 'cui_str': 'Pediatric oncology'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0439148', 'cui_str': 'Unit'}]","[{'cui': 'C0033963', 'cui_str': 'Psychosocial Factors'}]",200.0,0.0358755,"RESULTS


More improvements over time were observed in the high-intensity intervention group of child-parent units compared to the standard intervention group.
","[{'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Zucchetti', 'Affiliation': 'Pediatric Oncology Division, Azienda Ospedaliera-Universitaria Città della Salute e della Scienza, Turin, Italy.'}, {'ForeName': 'Giorgia', 'Initials': 'G', 'LastName': 'Ambrogio', 'Affiliation': 'Pediatric Division, ASL CN 1, Savigliano, Cuneo, Italy.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Bertolotti', 'Affiliation': 'Pediatric Oncology Division, Azienda Ospedaliera-Universitaria Città della Salute e della Scienza, Turin, Italy.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Besenzon', 'Affiliation': 'Pediatric Division, ASL CN 1, Savigliano, Cuneo, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Borghino', 'Affiliation': 'Pediatric Division, ASL CN 1, Savigliano, Cuneo, Italy.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Candela', 'Affiliation': 'University of Turin, Turin, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Galletto', 'Affiliation': 'Pediatric Division, ASL CN 1, Savigliano, Cuneo, Italy.'}, {'ForeName': 'Franca', 'Initials': 'F', 'LastName': 'Fagioli', 'Affiliation': 'Pediatric Oncology Division, Azienda Ospedaliera-Universitaria Città della Salute e della Scienza, Turin, Italy.'}]",Tumori,['10.1177/0300891620926226']
1096,32535812,"First-in-human, phase I single-ascending-dose study of the safety, pharmacokinetics, and relative bioavailability of selatinib, a dual EGFR-ErbB2 inhibitor in healthy subjects.","We assessed the pharmacokinetics and safety of a single oral administration of selatinib to healthy Chinese subjects and evaluated the potential bioavailability advantage of selatinib relative to lapatinib. Healthy subjects aged 18-40 years were enrolled in this two-part study: Part 1, a single ascending dose (50-500 mg), randomized, double-blind, placebo-control study with 64 subjects; and Part 2, an open-label, positive control, randomized, three-treatment, three-period, three-sequence crossover design study, with 6 subjects administered a single 500-mg dose of selatinib tablets (A), selatinib suspension (B), or lapatinib tablets C) per cycle. In part 1, selatinib was well-tolerated up to the planned maximum dose of 500 mg; thus the maximum tolerated dose was not attained. Twenty-two adverse events were observed in 19 (36.5%) of the 52 subjects administered the test drug. The most common drug-related adverse event was diarrhea. The mean selatinib peak plasma concentration was 69.4-494 ng/mL, which was achieved in a median peak time of 3.5-4.5 h, with a mean elimination half-life between 13.8 and 15.8 h. In Part 2, A and B showed similar bioavailability. Plasma exposure to the active drug (selatinib plus the metabolite, lapatinib) after A intake was more than two-fold higher than that of the same dose of C. In the dose range of 50-500 mg, selatinib was safe and well-tolerated by healthy Chinese subjects, and it conformed with linear pharmacokinetics. Active exposure to selatinib was much greater than that to lapatinib, supporting its development as an adjuvant for anticancer treatment.",2020,Twenty-two adverse events were observed in 19 (36.5%) of the 52 subjects administered the test drug.,"['Healthy subjects aged 18-40\xa0years', 'healthy Chinese subjects', 'healthy subjects']","['placebo-control study with 64 subjects; and Part 2, an open-label, positive control', 'selatinib tablets (A), selatinib suspension (B), or lapatinib tablets C', 'lapatinib']","['mean selatinib peak plasma concentration', 'pharmacokinetics and safety', 'safe and well-tolerated', 'bioavailability', 'adverse events']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C3852885', 'cui_str': 'selatinib'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}, {'cui': 'C1813640', 'cui_str': 'lapatinib Oral Tablet'}, {'cui': 'C1506770', 'cui_str': 'lapatinib'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3852885', 'cui_str': 'selatinib'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0590034,Twenty-two adverse events were observed in 19 (36.5%) of the 52 subjects administered the test drug.,"[{'ForeName': 'Meng-Na', 'Initials': 'MN', 'LastName': 'Wang', 'Affiliation': ""Center for Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, Hunan, 410013, People's Republic of China.""}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Kuang', 'Affiliation': ""Center for Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, Hunan, 410013, People's Republic of China.""}, {'ForeName': 'Li-Ying', 'Initials': 'LY', 'LastName': 'Gong', 'Affiliation': ""Center for Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, Hunan, 410013, People's Republic of China.""}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Hua', 'Affiliation': ""Center for Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, Hunan, 410013, People's Republic of China.""}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Pei', 'Affiliation': ""Department of Pharmacy, The Third Xiangya Hospital, Central South University, Changsha, Hunan, 410013, People's Republic of China.""}, {'ForeName': 'Cheng-Xian', 'Initials': 'CX', 'LastName': 'Guo', 'Affiliation': ""Center for Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, Hunan, 410013, People's Republic of China.""}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Cao', 'Affiliation': ""Department of Cardiology, The Third Xiangya Hospital, Central South University, Changsha, Hunan, 410013, People's Republic of China.""}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': ""Center for Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, Hunan, 410013, People's Republic of China. cellahuang1988@163.com.""}, {'ForeName': 'Guo-Ping', 'Initials': 'GP', 'LastName': 'Yang', 'Affiliation': ""Center for Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, Hunan, 410013, People's Republic of China. ygp9880@126.com.""}]",Investigational new drugs,['10.1007/s10637-020-00959-6']
1097,32537740,The ECG Belt for CRT response trial: Design and clinical protocol.,"The ECG Belt for CRT response trial is designed to test the hypothesis that in patients traditionally less likely to respond to cardiac resynchronization therapy (CRT), an individualized approach utilizing the electrocardiogram (ECG) Belt to guide lead placement, vector selection, and device programming is superior to current standard of care. The ECG Belt is a noninvasive mapping technology designed to measure beat by beat electrical activation of the left ventricle by utilizing unipolar measurements from multiple ECG electrodes on the body surface. The ECG Belt for CRT response trial is a multicenter, prospective, randomized, investigational pre-market research study conducted at 48 centers in the United States, Canada, and Europe and will randomize approximately 400 subjects. The trial has three arms (enrollment will be 2:1:1, respectively): utilization of the Belt to guide implant as well as postimplant programming, utilizing the Belt to guide postimplant programming alone, and a non-Belt control arm. AdaptivCRT will be an option in the treatment arm but not the control arms. The primary endpoint is change in left ventricular end-systolic volume between preimplant and at 6 months. This paper describes the design and analytic plan for the trial.",2020,The ECG Belt is a noninvasive mapping technology designed to measure beat by beat electrical activation of the left ventricle by utilizing unipolar measurements from multiple ECG electrodes on the body surface.,"['48 centers in the United States, Canada, and Europe and will randomize approximately 400 subjects']",['cardiac resynchronization therapy (CRT'],['change in left ventricular end-systolic volume'],"[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C3816746', 'cui_str': '400'}]","[{'cui': 'C1167956', 'cui_str': 'Cardiac resynchronisation therapy'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0455832', 'cui_str': 'Left ventricular end-systolic cavity size'}]",,0.0379119,The ECG Belt is a noninvasive mapping technology designed to measure beat by beat electrical activation of the left ventricle by utilizing unipolar measurements from multiple ECG electrodes on the body surface.,"[{'ForeName': 'John', 'Initials': 'J', 'LastName': 'Rickard', 'Affiliation': 'Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Jackson', 'Affiliation': 'Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Biffi', 'Affiliation': ""Policlinico Sant'Orsola-Malpighi, University of Bologna, Bologna, Italy.""}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Vernooy', 'Affiliation': 'Department of Cardiology, Maastricht Universitair Medisch Centrum, Maastricht, The Netherlands.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Bank', 'Affiliation': 'United Heart and Vascular Clinic, St Paul, Minnesota.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Cerkvenik', 'Affiliation': 'Medtronic, Plc, Fridley, Minnesota.'}, {'ForeName': 'Subham', 'Initials': 'S', 'LastName': 'Ghosh', 'Affiliation': 'Medtronic, Plc, Fridley, Minnesota.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Gold', 'Affiliation': 'Department of Medicine, Division of Cardiology, Medical University of South Carolina, Charleston, South Carolina.'}]",Pacing and clinical electrophysiology : PACE,['10.1111/pace.13985']
1098,32536023,"Human milk oligosaccharide supplementation in irritable bowel syndrome patients: A parallel, randomized, double-blind, placebo-controlled study.","OBJECTIVES


Human milk oligosaccharides safely and beneficially impact bifidobacteria abundance in healthy adults, while their effects in patients with irritable bowel syndrome (IBS) are unknown. Hence, we aimed to determine the dose of 4:1 mix of 2'-O-fucosyllactose and Lacto-N-neotetraose (2'FL/LNnT) that increases fecal bifidobacteria abundance without aggravating overall gastrointestinal symptoms in IBS patients in a randomized, double-blind, controlled study. Additionally, the impact of 2'FL/LNnT on the fecal bacterial profile was assessed.
METHODS


Irritable bowel syndrome patients diagnosed according to the Rome IV criteria received placebo (glucose), or 5 g or 10 g 2'FL/LNnT for 4 weeks followed by a four-week follow-up period. Gastrointestinal Symptom Rating Scale-IBS was used to assess gastrointestinal symptom severity; fecal microbiota composition was evaluated by GA-map™ Dysbiosis Test.
RESULTS


Of the included 60 patients, two (one placebo and one 10 g) discontinued prematurely. Fecal bifidobacteria abundance was increased at week 4, but not at week 8, in the 10 g group compared to the other groups. Severity of overall or individual gastrointestinal symptoms did not differ between the groups at week 4 or 8, and no symptom deterioration was seen in any of the groups. The 10 g dose influenced overall fecal microbiota composition, and responders-defined as bifidobacteria increase ≥50%-could be discriminated from non-responders based on fecal microbiota modulation.
CONCLUSIONS


The 10 g dose of 2'FL/LNnT induced an increase in the beneficial Bifidobacterium spp. without aggravating gastrointestinal symptoms in patients with IBS. This approach may be worthwhile to modulate gut microbiota of IBS patients toward a healthier profile.",2020,"Severity of overall or individual gastrointestinal symptoms did not differ between the groups at week 4 or 8, and no symptom deterioration was seen in any of the groups.","['Irritable bowel syndrome patients diagnosed according to the Rome IV criteria received', 'IBS patients', 'patients with irritable bowel syndrome (IBS', 'healthy adults', 'irritable bowel syndrome patients', 'patients with IBS']","['Human milk oligosaccharide supplementation', ""placebo (glucose), or 5\xa0g or 10\xa0g 2'FL/LNnT"", ""2'-O-fucosyllactose and Lacto-N-neotetraose (2'FL/LNnT"", ""2'FL/LNnT"", 'placebo']","['gastrointestinal symptom severity; fecal microbiota composition', 'Fecal bifidobacteria abundance', 'Severity of overall or individual gastrointestinal symptoms', 'fecal bifidobacteria abundance', 'fecal bacterial profile', 'overall fecal microbiota composition', 'symptom deterioration', 'Gastrointestinal Symptom Rating Scale-IBS']","[{'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0026140', 'cui_str': 'Breast milk'}, {'cui': 'C0028959', 'cui_str': 'Oligosaccharide'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1318182', 'cui_str': '10G'}, {'cui': 'C0064595', 'cui_str': 'lacto-N-neotetraose'}]","[{'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}]",60.0,0.247149,"Severity of overall or individual gastrointestinal symptoms did not differ between the groups at week 4 or 8, and no symptom deterioration was seen in any of the groups.","[{'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Iribarren', 'Affiliation': 'Department of Microbiology and Immunology, Institute of Biomedicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Törnblom', 'Affiliation': 'Department of Internal Medicine and Clinical Nutrition, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Imran', 'Initials': 'I', 'LastName': 'Aziz', 'Affiliation': 'Department of Internal Medicine and Clinical Nutrition, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Maria K', 'Initials': 'MK', 'LastName': 'Magnusson', 'Affiliation': 'Department of Microbiology and Immunology, Institute of Biomedicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Sundin', 'Affiliation': 'Department of Internal Medicine and Clinical Nutrition, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Louise K', 'Initials': 'LK', 'LastName': 'Vigsnaes', 'Affiliation': 'Glycom A/S, Hørsholm, Denmark.'}, {'ForeName': 'Ingvild Dybdrodt', 'Initials': 'ID', 'LastName': 'Amundsen', 'Affiliation': 'Glycom A/S, Hørsholm, Denmark.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'McConnell', 'Affiliation': 'Glycom A/S, Hørsholm, Denmark.'}, {'ForeName': 'Dorthe', 'Initials': 'D', 'LastName': 'Seitzberg', 'Affiliation': 'Glycom A/S, Hørsholm, Denmark.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Öhman', 'Affiliation': 'Department of Microbiology and Immunology, Institute of Biomedicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Simrén', 'Affiliation': 'Department of Internal Medicine and Clinical Nutrition, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}]",Neurogastroenterology and motility : the official journal of the European Gastrointestinal Motility Society,['10.1111/nmo.13920']
1099,32535161,Urethra-Sparing Stereotactic Body Radiation Therapy for Prostate Cancer: Quality Assurance of a Randomized Phase 2 Trial.,"PURPOSE


To present the radiation therapy quality assurance results from a prospective multicenter phase 2 randomized trial of short versus protracted urethra-sparing stereotactic body radiation therapy (SBRT) for localized prostate cancer.
METHODS AND MATERIALS


Between 2012 and 2015, 165 patients with prostate cancer from 9 centers were randomized and treated with SBRT delivered either every other day (arm A, n = 82) or once a week (arm B, n = 83); 36.25 Gy in 5 fractions were prescribed to the prostate with (n = 92) or without (n = 73) inclusion of the seminal vesicles (SV), and the urethra planning-risk volume received 32.5 Gy. Patients were treated either with volumetric modulated arc therapy (VMAT; n = 112) or with intensity modulated radiation therapy (IMRT; n = 53). Deviations from protocol dose constraints, planning target volume (PTV) homogeneity index, PTV Dice similarity coefficient, and number of monitor units for each treatment plan were retrospectively analyzed. Dosimetric results of VMAT versus IMRT and treatment plans with versus without inclusion of SV were compared.
RESULTS


At least 1 major protocol deviation occurred in 51 patients (31%), whereas none was observed in 41. Protocol violations were more frequent in the IMRT group (P < .001). Furthermore, the use of VMAT yielded better dosimetric results than IMRT for urethra planning-risk volume D 98%  (31.1 vs 30.8 Gy, P < .0001), PTV D 2%  (37.9 vs 38.7 Gy, P < .0001), homogeneity index (0.09 vs 0.10, P < .0001), Dice similarity coefficient (0.83 vs 0.80, P < .0001), and bladder wall V 50%  (24.5% vs 33.5%, P = .0001). To achieve its goals volumetric modulated arc therapy required fewer monitor units than IMRT (2275 vs 3378, P <.0001). The inclusion of SV in the PTV negatively affected the rectal wall V 90%  (9.1% vs 10.4%, P = .0003) and V 80%  (13.2% vs 15.7%, P = .0003).
CONCLUSIONS


Protocol deviations with potential impact on tumor control or toxicity occurred in 31% of patients in this prospective clinical trial. Protocol deviations were more frequent with IMRT. Prospective radiation therapy quality assurance protocols should be strongly recommended for SBRT trials to minimize potential protocol deviations.",2020,"To achieve its goals VMAT required less MU than IMRT (2275 vs. 3378, p<0.0001).","['Between 2012 and 2015, 165 PCa patients from nine centers', 'localized prostate cancer (PCa', 'prostate cancer']","['radiotherapy quality assurance (RTQA', 'IMRT', 'Urethra-sparing stereotactic body radiotherapy', 'SBRT', 'VMAT vs. IMRT', 'protracted urethra-sparing stereotactic body radiotherapy (SBRT', 'VMAT']","['PTV homogeneity index (HI), PTV Dice similarity coefficient (DSC), and number of monitor units (MU', 'toxicity', 'DSC']","[{'cui': 'C4319555', 'cui_str': '165'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C1512814', 'cui_str': 'Intensity modulated radiation therapy'}, {'cui': 'C0041967', 'cui_str': 'Urethral'}, {'cui': 'C1843661', 'cui_str': 'Spastic Paraplegia, Ataxia, And Mental Retardation'}, {'cui': 'C1720823', 'cui_str': 'Stereotactic Body Radiotherapy'}, {'cui': 'C3489631', 'cui_str': 'Intensity-Modulated Arc Therapy'}]","[{'cui': 'C0454199', 'cui_str': 'Planning target volume'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0040539', 'cui_str': 'TO'}]",165.0,0.0661156,"To achieve its goals VMAT required less MU than IMRT (2275 vs. 3378, p<0.0001).","[{'ForeName': 'Maud', 'Initials': 'M', 'LastName': 'Jaccard', 'Affiliation': 'Radiation Oncology, University Hospital of Geneva, Geneva, Switzerland. Electronic address: maud.jaccard@hcuge.ch.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Zilli', 'Affiliation': 'Radiation Oncology, University Hospital of Geneva, Geneva, Switzerland; Faculty of Medicine, Geneva University, Geneva, Switzerland.'}, {'ForeName': 'Angèle', 'Initials': 'A', 'LastName': 'Dubouloz', 'Affiliation': 'Radiation Oncology, University Hospital of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Lluís', 'Initials': 'L', 'LastName': 'Escude', 'Affiliation': 'Radiation Oncology, Teknon Oncologic Institute, Barcelona, Spain.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Jorcano', 'Affiliation': 'Radiation Oncology, Teknon Oncologic Institute, Barcelona, Spain.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Linthout', 'Affiliation': 'Onze-Lieve-Vrouwziekenhuis, Aalst, Belgium.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Bral', 'Affiliation': 'Onze-Lieve-Vrouwziekenhuis, Aalst, Belgium.'}, {'ForeName': 'Wilko', 'Initials': 'W', 'LastName': 'Verbakel', 'Affiliation': 'Radiation Oncology Amsterdam UMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Bruynzeel', 'Affiliation': 'Radiation Oncology Amsterdam UMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Mikko', 'Initials': 'M', 'LastName': 'Björkqvist', 'Affiliation': 'Department of Oncology and Radiotherapy, Turku University Hospital, Turku, Finland; Department of Medical Physics, Division of Medical Imaging, Turku University Hospital, Turku, Finland.'}, {'ForeName': 'Heikki', 'Initials': 'H', 'LastName': 'Minn', 'Affiliation': 'Department of Oncology and Radiotherapy, Turku University Hospital, Turku, Finland.'}, {'ForeName': 'Lev', 'Initials': 'L', 'LastName': 'Tsvang', 'Affiliation': 'Sheba Medical Center, Ramat Gan, Israel.'}, {'ForeName': 'Zvi', 'Initials': 'Z', 'LastName': 'Symon', 'Affiliation': 'Sheba Medical Center, Ramat Gan, Israel.'}, {'ForeName': 'Joana', 'Initials': 'J', 'LastName': 'Lencart', 'Affiliation': 'Faculty of Medicine, Geneva University, Geneva, Switzerland.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Oliveira', 'Affiliation': 'Portuguese Institut of Oncology, Porto, Portugal.'}, {'ForeName': 'Zeynep', 'Initials': 'Z', 'LastName': 'Ozen', 'Affiliation': 'Neolife Medical Center, Istanbul, Turkey.'}, {'ForeName': 'Ufuk', 'Initials': 'U', 'LastName': 'Abacioglu', 'Affiliation': 'Neolife Medical Center, Istanbul, Turkey.'}, {'ForeName': 'Juan María', 'Initials': 'JM', 'LastName': 'Pérez-Moreno', 'Affiliation': 'Hospital Universitario Sanchinarro, Madrid, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Rubio', 'Affiliation': 'Hospital Universitario Sanchinarro, Madrid, Spain.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Rouzaud', 'Affiliation': 'Radiation Oncology, University Hospital of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Miralbell', 'Affiliation': 'Radiation Oncology, University Hospital of Geneva, Geneva, Switzerland; Faculty of Medicine, Geneva University, Geneva, Switzerland; Radiation Oncology, Teknon Oncologic Institute, Barcelona, Spain.'}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2020.06.002']
1100,32537853,Authors' reply re: Laparoscopic ablation or excision with helium thermal coagulator versus electrodiathermy for the treatment of mild-to-moderate endometriosis: randomised controlled trial.,,2020,,['mild-to-moderate endometriosis'],['Laparoscopic ablation or excision with helium thermal coagulator versus electrodiathermy'],[],"[{'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0018880', 'cui_str': 'Helium'}]",[],,0.0726803,,"[{'ForeName': 'Gourab', 'Initials': 'G', 'LastName': 'Misra', 'Affiliation': 'Maternity Unit, University Hospitals of North Midlands, Royal Stoke University Hospital, Staffordshire, UK.'}, {'ForeName': 'Julius', 'Initials': 'J', 'LastName': 'Sim', 'Affiliation': 'School of Primary, Community and Social Care, Keele University, Staffordshire, UK.'}, {'ForeName': 'Keira', 'Initials': 'K', 'LastName': 'Watts', 'Affiliation': 'Research and Innovation, University Hospitals of North Midlands, Royal Stoke University Hospital, Staffordshire, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Coia', 'Affiliation': 'Maternity Unit, University Hospitals of North Midlands, Royal Stoke University Hospital, Staffordshire, UK.'}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16333']
1101,32535646,Patient safety incidents and medication errors during a clinical trial: experience from a pre-hospital randomized controlled trial of emergency medication administration.,"AIM


To assess and evaluate patient safety incidents and in particular, medication errors, during a large multi-center pre-hospital trial of emergency therapy (PARAMEDIC2), in order to inform and improve future pre-hospital medicines trials.
METHODS


The PARAMEDIC2 trial was undertaken across five NHS Ambulance Services in England and Wales with randomisation between December 2014 and October 2017. Patients with an out -of-hospital cardiac arrest unresponsive to initial resuscitation were randomly assigned to 1 mg intravenous adrenaline or matching placebo. Records were reviewed to identify trial medication errors involving documentation and/or clinical protocol errors occurring in trial participants. Causes of medication errors, including root cause analysis where available, were reviewed to identify patterns and themes contributing to these errors.
RESULTS


Eight thousand sixteen patients were enrolled, of whom 4902 received trial medication. A total of 331 patient safety incidents was reported, involving 295 patients, representing an overall rate of 3.6% of these, 166 (50.2%) were documentation errors while 165 (49.8%) were clinical protocol/medication errors. An overall rate of 0-4.5% was reported across all five ambulance services, with a mean of 2.0%. These errors had no impact on patient care or the trial and were all resolved CONCLUSION: The overall medication error rate of 1.8% primarily consisted of administration of open-label adrenaline and confusion with trial medication packs. A similar number of patients had documentation errors. This study is the first to provide data on patient safety incidents relating to medication errors encountered during a pre-hospital trial of emergency medication administration and will provide supporting data for planning future trials in this area.",2020,These errors had no impact on patient care or the trial and were all resolved CONCLUSION: The overall medication error rate of 1.8% primarily consisted of administration of open-label adrenaline and confusion with trial medication packs.,"['Patients with an out -of-hospital cardiac arrest unresponsive to initial resuscitation', 'five NHS Ambulance Services in England and Wales with randomisation between December 2014 and October 2017', 'Eight thousand sixteen patients were enrolled, of whom 4902 received trial medication']",['adrenaline or matching placebo'],"['overall medication error rate', 'overall rate', 'documentation errors']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2936490', 'cui_str': 'Out-of-Hospital Heart Arrest'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}, {'cui': 'C0002422', 'cui_str': 'Ambulance'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0043015', 'cui_str': 'Wales'}, {'cui': 'C3840857', 'cui_str': '8000'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0025115', 'cui_str': 'Medication error'}, {'cui': 'C0175636', 'cui_str': 'Documentation procedure'}]",8016.0,0.110179,These errors had no impact on patient care or the trial and were all resolved CONCLUSION: The overall medication error rate of 1.8% primarily consisted of administration of open-label adrenaline and confusion with trial medication packs.,"[{'ForeName': 'Ed', 'Initials': 'E', 'LastName': 'England', 'Affiliation': 'South Central Ambulance Service NHS Foundation Trust, Otterbourne, SO21 2RU, UK.'}, {'ForeName': 'Charles D', 'Initials': 'CD', 'LastName': 'Deakin', 'Affiliation': 'South Central Ambulance Service NHS Foundation Trust, Otterbourne, SO21 2RU, UK.'}, {'ForeName': 'Jerry P', 'Initials': 'JP', 'LastName': 'Nolan', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, CV4 7AL, UK.'}, {'ForeName': 'Ranjit', 'Initials': 'R', 'LastName': 'Lall', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, CV4 7AL, UK.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Quinn', 'Affiliation': ""Kingston University and St George's, University of London, 6th Floor, Hunter Wing, Cranmer Terrace, London, SW17 0RE, UK.""}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Gates', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, University of Birmingham, Birmingham, B15 2TT, UK.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Miller', 'Affiliation': 'West Midlands Ambulance Service University NHS Foundation Trust, Brierley Hill, West Midlands, DY5 1LX, UK.'}, {'ForeName': 'Lyndsey', 'Initials': 'L', 'LastName': ""O'Shea"", 'Affiliation': 'Welsh Ambulance Services NHS Trust, Swansea, Wales, SA2 8PP, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Pocock', 'Affiliation': 'South Central Ambulance Service NHS Foundation Trust, Otterbourne, SO21 2RU, UK.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Rees', 'Affiliation': 'Welsh Ambulance Services NHS Trust, Swansea, Wales, SA2 8PP, UK.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Scomparin', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, CV4 7AL, UK.'}, {'ForeName': 'Gavin D', 'Initials': 'GD', 'LastName': 'Perkins', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, CV4 7AL, UK. paramedic@warwick.ac.uk.'}]",European journal of clinical pharmacology,['10.1007/s00228-020-02887-z']
1102,32546726,Phase II trial of CPX-351 in patients with acute myeloid leukemia at high risk for induction mortality.,"CPX-351 is a liposomal formulation of cytarabine/daunorubicin with a 5:1 fixed molar ratio. We investigated the safety and efficacy of escalating doses of CPX-351 in patients with acute myeloid leukemia (AML) at high risk of induction mortality with standard chemotherapy determined through assessment of leukemia and patient-related risk factors for intensive chemotherapy in an open-label, phase II trial. Patients were randomized to receive 50 or 75 units/m 2  on days 1, 3, and 5. Once safety was established, a 100 units/m 2  arm was opened. Fifty-six patients were enrolled, 16, 24, and 16 in the 50, 75, and 100 units/m 2  arms, respectively. The composite complete remission rate (complete remission + complete remission with incomplete blood count recovery) was lowest with 50 units/m 2  (19%) compared with 75 units/m 2  (38%) and 100 units/m 2  (44%) (P = 0.35). The 50 units/m 2  arm had a median OS of 4.3 months, compared with 8.6 and 6.2 months for the 75 and 100 units/m 2  respectively (P = 0.04). Nonhematologic grade 3/4 treatment-emergent adverse events included febrile neutropenia (34%), pneumonia (23%), and sepsis (16%). CPX-351 at 75 units/m 2  has favorable safety and efficacy for AML patients at high risk of induction mortality with some tolerating the standard dose of 100 units/m 2 .",2020,"The 50 units/m 2  arm had a median OS of 4.3 months, compared with 8.6 and 6.2 months for the 75 and 100 units/m 2  respectively (P = 0.04).","['patients with acute myeloid leukemia at high risk for induction mortality', 'Fifty-six patients were enrolled, 16, 24, and 16 in the 50, 75, and 100\u2009units/m 2  arms, respectively', 'patients with acute myeloid leukemia (AML) at high risk of induction mortality with standard chemotherapy determined through assessment of leukemia and patient-related risk factors for intensive chemotherapy in an open-label, phase II trial']","['cytarabine/daunorubicin', 'CPX-351']","['median OS', 'safety and efficacy', 'Nonhematologic grade 3/4 treatment-emergent adverse events included febrile neutropenia', 'composite complete remission rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0023418', 'cui_str': 'Leukemia'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}]","[{'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0011015', 'cui_str': 'Daunorubicin'}, {'cui': 'C2346682', 'cui_str': 'CPX-351'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}]",56.0,0.0785846,"The 50 units/m 2  arm had a median OS of 4.3 months, compared with 8.6 and 6.2 months for the 75 and 100 units/m 2  respectively (P = 0.04).","[{'ForeName': 'Ghayas C', 'Initials': 'GC', 'LastName': 'Issa', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Hagop M', 'Initials': 'HM', 'LastName': 'Kantarjian', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Lianchun', 'Initials': 'L', 'LastName': 'Xiao', 'Affiliation': 'Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Ning', 'Affiliation': 'Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Yesid', 'Initials': 'Y', 'LastName': 'Alvarado', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Gautam', 'Initials': 'G', 'LastName': 'Borthakur', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Naval', 'Initials': 'N', 'LastName': 'Daver', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Courtney D', 'Initials': 'CD', 'LastName': 'DiNardo', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Elias', 'Initials': 'E', 'LastName': 'Jabbour', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Prithviraj', 'Initials': 'P', 'LastName': 'Bose', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Nitin', 'Initials': 'N', 'LastName': 'Jain', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Tapan M', 'Initials': 'TM', 'LastName': 'Kadia', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Kiran', 'Initials': 'K', 'LastName': 'Naqvi', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Naveen', 'Initials': 'N', 'LastName': 'Pemmaraju', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Srdan', 'Initials': 'S', 'LastName': 'Verstovsek', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Micheal', 'Initials': 'M', 'LastName': 'Andreeff', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Kornblau', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Zeev', 'Initials': 'Z', 'LastName': 'Estrov', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Ferrajoli', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Garcia-Manero', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Maro', 'Initials': 'M', 'LastName': 'Ohanian', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'William G', 'Initials': 'WG', 'LastName': 'Wierda', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Farhad', 'Initials': 'F', 'LastName': 'Ravandi', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Jorge E', 'Initials': 'JE', 'LastName': 'Cortes', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA. jorge.cortes@augusta.edu.'}]",Leukemia,['10.1038/s41375-020-0916-8']
1103,32559278,Diet Quality and Associations with Food Security among Women Eligible for Indiana Supplemental Nutrition Assistance Program-Education.,"BACKGROUND


The diet quality among adults receiving nutrition education lessons through Supplemental Nutrition Assistance Program-Education (SNAP-Ed) is currently unknown.
OBJECTIVES


The objectives of this study were to characterize the diet quality of Indiana SNAP-Ed-eligible women; estimate their mean usual intake of fruits, vegetables, dairy, and whole grains compared to Dietary Guidelines for Americans (DGA) recommendations; and determine if these dietary outcomes differed by food security status.
METHODS


SNAP-Ed paraprofessionals recruited participants from August 2015 to May 2016 for this secondary analysis of cross-sectional data collected as the baseline assessment for a randomized controlled trial. Participants were SNAP-Ed-eligible women aged ≥18 y interested in nutrition education lessons. Dietary outcomes were assessed by one or two 24-h dietary recalls. The Healthy Eating Index (HEI)-2010 was used to characterize diet quality. Mean usual intake of food groups was estimated using the National Cancer Institute Method. Food security status was classified using the US Household Food Security Survey Module. Data were analyzed in October 2019.
RESULTS


Mean ± SEM HEI-2010 total score was 42 ± 0.9 for the study sample. Mean ± SE usual intake of servings of fruits (0.61 ± 0.08 cups [144.32 ± 18.93 mL]), vegetables [1.4 ± 0.10 cups (331.2 ± 23.66 mL)], dairy [1.5 ± 0.11 cups (354.88 ± 26.02 mL)], and whole grains [0.48 ± 0.06 ounces (13.61 ± 1.70 g)] did not differ by food security subgroup. Mean HEI-2010 total score was significantly higher by 4.8 ± 2.0 points for the food-secure than for the food-insecure subgroup (P = 0.01). Mean HEI-2010 component scores were 1.1 ± 0.5 points higher for whole grain (P = 0.01) and 1.0 ± 0.5 points higher for dairy (P = 0.05) in the food-secure than in the food-insecure subgroup. The proportions of the study sample not meeting the DGA recommendations for food group intake were ≥85% for both food-secure and -insecure subgroups.
CONCLUSIONS


Indiana SNAP-Ed-eligible women reported poor diet quality, highlighting their need for nutrition interventions aiming to improve food security and diet as per DGA recommendations in low-income populations.",2020,Mean HEI-2010 total score was significantly higher by 4.8 ± 2.0 points for the food-secure than for the food-insecure subgroup (P = 0.01).,"['Women Eligible for Indiana Supplemental Nutrition Assistance Program-Education', 'Participants were SNAP-Ed-eligible women aged ≥18 y interested in nutrition education lessons', 'SNAP-Ed paraprofessionals recruited participants from August 2015 to May 2016 for this secondary analysis of cross-sectional data collected as the baseline assessment for a randomized controlled trial', 'Indiana SNAP-Ed-eligible women', 'adults receiving nutrition education lessons']",[],"['Mean HEI-2010 total score', 'Mean HEI-2010 component scores', 'Healthy Eating Index', 'Mean\xa0±\xa0SEM HEI-2010 total score', 'Mean\xa0±\xa0SE usual intake of servings of fruits']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0021206', 'cui_str': 'Indiana'}, {'cui': 'C3494397', 'cui_str': 'SNAP Program'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4280021', 'cui_str': 'Healthy Eating Index'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0262878', 'cui_str': 'Scanning electron microscope'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}]",,0.0751539,Mean HEI-2010 total score was significantly higher by 4.8 ± 2.0 points for the food-secure than for the food-insecure subgroup (P = 0.01).,"[{'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Rivera', 'Affiliation': 'Department of Nutrition Science, Purdue University, West Lafayette, IN, USA.'}, {'ForeName': 'Yumin', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Statistics, Purdue University, West Lafayette, IN, USA.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Department of Statistics, Purdue University, West Lafayette, IN, USA.'}, {'ForeName': 'Melissa K', 'Initials': 'MK', 'LastName': 'Maulding', 'Affiliation': 'Department of Nutrition and Dietetics, Eastern Illinois University, Charleston, IL, USA.'}, {'ForeName': 'Janet A', 'Initials': 'JA', 'LastName': 'Tooze', 'Affiliation': 'School of Medicine, Wake Forest University, Winston-Salem, NC, USA.'}, {'ForeName': 'Breanne N', 'Initials': 'BN', 'LastName': 'Wright', 'Affiliation': 'Department of Nutrition Science, Purdue University, West Lafayette, IN, USA.'}, {'ForeName': 'Bruce A', 'Initials': 'BA', 'LastName': 'Craig', 'Affiliation': 'Department of Statistics, Purdue University, West Lafayette, IN, USA.'}, {'ForeName': 'Regan L', 'Initials': 'RL', 'LastName': 'Bailey', 'Affiliation': 'Department of Nutrition Science, Purdue University, West Lafayette, IN, USA.'}, {'ForeName': 'Heather A', 'Initials': 'HA', 'LastName': 'Eicher-Miller', 'Affiliation': 'Department of Nutrition Science, Purdue University, West Lafayette, IN, USA.'}]",The Journal of nutrition,['10.1093/jn/nxaa171']
1104,32546421,Small changes in glucose variability induced by low and high glycemic index diets are not associated with changes in β-cell function in adults with pre-diabetes.,"Oscillating glucose levels can increase oxidative stress and may contribute to β-cell dysfunction. We tested the hypothesis that increased glycemic variability contributes to β-cell dysfunction by experimentally altering glucose variability with controlled diets varying in glycemic index (GI). Fifty-two adults with prediabetes received a 2-week moderate GI (GI = 55-58) control diet followed by randomization to a four-week low GI (LGI: GI < 35) or high GI (HGI HI > 70) diet. Those on the HGI diet were randomized to placebo or the antioxidant N-acetylcysteine (NAC). Participants underwent blinded CGMS, fasting oxidative stress markers and an intravenous glucose tolerance test to estimate β-cell function (disposition index: DI). On the control diet, DI was inversely correlated with SD glucose (r = -0.314, p = 0.03), but neither DI nor glucose variability were associated with oxidative stress markers. The LGI diet decreased SD glucose (Control 0.96 ± 0.08 vs. LGI 0.79 ± 0.06, p = 0.02) while the HGI diet increased it (Control 0.88 ± 0.06 vs. HGI 1.06 ± 0.07, p = 0.03). Neither DI nor oxidative stress markers changed after the LGI or HGI diets. NAC had no effect on DI, glucose variability or oxidative stress markers. We conclude small changes in glucose variability induced by dietary GI in adults with pre-diabetes are unlikely to contribute to β-cell dysfunction.",2020,"The LGI diet decreased SD glucose (Control 0.96 ± 0.08 vs. LGI 0.79 ± 0.06, p = 0.02) while the HGI diet increased it (Control 0.88 ± 0.06 vs. HGI 1.06 ± 0.07, p = 0.03).","['Fifty-two adults with prediabetes received a', 'adults with pre-diabetes']","['2-week moderate GI (GI\u202f=\u202f55-58) control diet followed by randomization to a four-week low GI (LGI: GI\u202f<\u202f35) or high GI (HGI HI', 'antioxidant N-acetylcysteine (NAC', 'NAC', 'placebo']","['oxidative stress markers', 'oxidative stress', 'SD glucose', 'glucose variability', 'β-cell function', 'DI, glucose variability or oxidative stress markers']","[{'cui': 'C4319570', 'cui_str': '52'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C1136206', 'cui_str': 'Glycemic Index Number'}, {'cui': 'C0743195', 'cui_str': 'Dietary control'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0007613', 'cui_str': 'Physiology, Cell'}]",52.0,0.0150612,"The LGI diet decreased SD glucose (Control 0.96 ± 0.08 vs. LGI 0.79 ± 0.06, p = 0.02) while the HGI diet increased it (Control 0.88 ± 0.06 vs. HGI 1.06 ± 0.07, p = 0.03).","[{'ForeName': 'Kristina M', 'Initials': 'KM', 'LastName': 'Utzschneider', 'Affiliation': 'Research and Development, Department of Medicine, 1660 S Columbian Way (151), VA Puget Sound Health Care System, Seattle, WA 98108, USA; Division of Metabolism, Endocrinology and Nutrition, University of Washington, 1959 NE Pacific Street, Seattle, WA 98195-6426, USA. Electronic address: kutzschn@uw.edu.'}, {'ForeName': 'Tonya N', 'Initials': 'TN', 'LastName': 'Johnson', 'Affiliation': 'Research and Development, Department of Medicine, 1660 S Columbian Way (151), VA Puget Sound Health Care System, Seattle, WA 98108, USA; Seattle Institute for BIomedical and Clinical Research, Seattle, WA, USA.'}, {'ForeName': 'Kara L', 'Initials': 'KL', 'LastName': 'Breymeyer', 'Affiliation': 'Public Health Sciences Division, Fred Hutchinson Cancer Research Center, 1100 Fairview Ave N, Seattle, WA 98109, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Bettcher', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, University of Washington, 1959 NE Pacific Street, Seattle, WA 98195-6426, USA. Electronic address: bettcher@uw.edu.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Raftery', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, University of Washington, 1959 NE Pacific Street, Seattle, WA 98195-6426, USA. Electronic address: draftery@uw.edu.'}, {'ForeName': 'Katherine M', 'Initials': 'KM', 'LastName': 'Newton', 'Affiliation': 'Kaiser Permanente Health Research Institute, 1730 Minor Ave, Seattle, WA 98101, USA. Electronic address: Katherine.M.Newton@kp.org.'}, {'ForeName': 'Marian L', 'Initials': 'ML', 'LastName': 'Neuhouser', 'Affiliation': 'Public Health Sciences Division, Fred Hutchinson Cancer Research Center, 1100 Fairview Ave N, Seattle, WA 98109, USA. Electronic address: mneuhous@fredhutch.org.'}]",Journal of diabetes and its complications,['10.1016/j.jdiacomp.2020.107586']
1105,32553191,"Aqueous olanexidine versus aqueous povidone-iodine for surgical skin antisepsis on the incidence of surgical site infections after clean-contaminated surgery: a multicentre, prospective, blinded-endpoint, randomised controlled trial.","BACKGROUND


Surgical site infection (SSI) is the most common problem after surgery. Although several guidelines have indicated the efficacy of antiseptics, such as chlorhexidine-alcohol and povidone-iodine, in reducing SSI rate, the optimal recommendation is still not established. Olanexidine might have higher bactericidal activity than other antiseptic agents. However, no randomised study has evaluated the efficacy and safety of olanexidine over conventional antiseptics. We compared the effect of aqueous olanexidine and aqueous povidone-iodine on the incidence of SSI following clean-contaminated surgery.
METHODS


This was a multicentre, prospective, randomised, blinded-endpoint superiority trial for surgical skin antisepsis in clean-contaminated gastrointestinal and hepatobiliary pancreatic surgeries in four Japanese hospitals. Patients aged 20 years or older who underwent elective clean-contaminated wound surgery were randomly assigned in a 1:1 replacement ratio using a computer-generated block randomisation. Patients were randomly assigned to surgical skin antisepsis with an aqueous formulation of 1·5% olanexidine or surgical skin antisepsis with an aqueous formulation of 10% povidone-iodine before surgery. We used olanexidine in a ready-to-use applicator, and povidone-iodine was administered by a brush or by compression using pliers. Both antiseptics were applied from the papilla with a cranial limit and to the upper thigh with a caudal limit. The antiseptics were allowed to dry for 3 min, and then surgery started. Participants, some investigators, and data analysts were masked to treatment allocation. Participant enrolment was done by non-masked investigators. The primary outcome was 30-day SSI assessed in the intention-to-treat population. The surgical wound site of each participant was observed daily. After discharge, participants underwent at least one outpatient visit within 30 days after surgery. This trial is registered with University hospital Medical Information Network, 000031560.
FINDINGS


Between June 10, 2018, and April 18, 2019, 883 patients were assessed for eligibility. 587 patients were eligible and 294 received olanexidine and 293 received aqueous povidone-iodine before surgery. 30-day SSI occurred in 19 (7%) patients in the olanexidine group and 39 patients (13%) patients in the povidone-iodine group (adjusted risk difference -0·069; 90% CI -0·109 to -0·029; adjusted risk ratio [RR] 0·48, 90% CI 0·30 to 0·74; p=0·002). Five patients (2%) in the olanexidine group and five (2%) in the povidone-iodine group developed adverse skin reactions (adjusted RR 0·99, 95% CI 0·29 to 3·40; p=1·00).
INTERPRETATION


Olanexidine significantly reduced the occurrence of overall SSI and superficial incisional SSI compared with aqueous povidone-iodine in clean-contaminated surgery. Our results indicate that olanexidine might have a role to prevent SSI in patients who undergo clean-contaminated surgeries.
FUNDING


Keio University and Ohyama Health Foundation.",2020,"INTERPRETATION


Olanexidine significantly reduced the occurrence of overall SSI and superficial incisional SSI compared with aqueous povidone-iodine in clean-contaminated surgery.","['Patients aged 20 years or older who underwent elective clean-contaminated wound surgery', 'Between June 10, 2018, and April 18, 2019', 'patients who undergo clean-contaminated surgeries', '587 patients were eligible and 294 received', 'clean-contaminated gastrointestinal and hepatobiliary pancreatic surgeries in four Japanese hospitals', 'surgical site infections after clean-contaminated surgery', '0·48', '883 patients were assessed for eligibility']","['surgical skin antisepsis with an aqueous formulation of 1·5% olanexidine or surgical skin antisepsis with an aqueous formulation of 10% povidone-iodine before surgery', 'olanexidine and 293 received aqueous povidone-iodine before surgery', 'chlorhexidine-alcohol and povidone-iodine', 'aqueous olanexidine and aqueous povidone-iodine', 'Olanexidine', 'olanexidine', 'Aqueous olanexidine versus aqueous povidone-iodine', 'povidone-iodine', 'surgical skin antisepsis', 'aqueous povidone-iodine']","['SSI rate', 'adverse skin reactions', '30-day SSI assessed in the intention-to-treat population', 'bactericidal activity', 'efficacy and safety', '30-day SSI', 'occurrence of overall SSI and superficial incisional SSI', 'risk ratio [RR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0205279', 'cui_str': 'Contaminated'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0030274', 'cui_str': 'Pancreatic structure'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0003424', 'cui_str': 'Antisepsis'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0755906', 'cui_str': 'olanexidine'}, {'cui': 'C0032857', 'cui_str': 'Povidone-Iodine'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}]","[{'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0221743', 'cui_str': 'Skin reaction'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0544570', 'cui_str': 'Bactericidal activity'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C3662309', 'cui_str': 'Superficial incisional surgical site infection'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}]",883.0,0.17549,"INTERPRETATION


Olanexidine significantly reduced the occurrence of overall SSI and superficial incisional SSI compared with aqueous povidone-iodine in clean-contaminated surgery.","[{'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Obara', 'Affiliation': 'Department of Surgery, Keio University School of Medicine, Tokyo, Japan. Electronic address: obara.z3@keio.jp.'}, {'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Takeuchi', 'Affiliation': 'Department of Surgery, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Kawakubo', 'Affiliation': 'Department of Surgery, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Shinoda', 'Affiliation': 'Department of Surgery, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Okabayashi', 'Affiliation': 'Department of Surgery, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Koki', 'Initials': 'K', 'LastName': 'Hayashi', 'Affiliation': 'Department of Surgery, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Yasuhito', 'Initials': 'Y', 'LastName': 'Sekimoto', 'Affiliation': 'Department of Surgery, National Hospital Organization Tokyo Medical Center, Tokyo, Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Maeda', 'Affiliation': 'Department of Surgery, Tokyo Saiseikai Central Hospital, Tokyo, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Kondo', 'Affiliation': 'Department of Surgery, Kawasaki Municipal Hospital, Kanagawa, Japan.'}, {'ForeName': 'Yasunori', 'Initials': 'Y', 'LastName': 'Sato', 'Affiliation': 'Department of Preventive Medicine and Public Health, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Kitagawa', 'Affiliation': 'Department of Surgery, Keio University School of Medicine, Tokyo, Japan.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(20)30225-5']
1106,32554534,Changes in respiratory symptoms during 48-week treatment with ARD-3150 (inhaled liposomal ciprofloxacin) in bronchiectasis: results from the ORBIT-3 and -4 studies.,"It is not known if inhaled antibiotics improve respiratory symptoms in patients with bronchiectasis. In the recent phase-3 ORBIT trials, 48 weeks' treatment with ARD-3150 (inhaled liposomal ciprofloxacin) did not significantly improve symptoms using the prespecified method of analysis comparing baseline symptoms to those after 48 weeks, when patients had been off treatment for 28 days. This method of analysis does not take account of possible improvements in symptoms while on active treatment.A  post hoc  analysis of two identical randomised trials of ARD-3150 (ORBIT-3 and -4) administered 28 days on and 28 days off in patients with bronchiectasis and chronic  Pseudomonas aeruginosa  infection. The quality-of-life bronchiectasis respiratory symptom scale (QOL-B-RSS), which has a one-week recall period, was administered every 28 days. We examined whether respiratory symptoms improved during on-treatment periods and the relationship of changes in QOL-B-RSS to changes in bacterial load using a mixed-model repeated measures approach.ARD-3150 treatment resulted in a significant improvement in respiratory symptoms during the on-treatment periods with concordant results between ORBIT-3 (estimate 1.4 points, se 0.49; p=0.004) and ORBIT-4 (estimate 1.1 point, se 0.41; p=0.006). The proportion of patients achieving a symptom improvement above the minimum clinically important difference was higher with ARD-3150 compared with placebo during on-treatment cycles (p=0.024). Changes in respiratory symptoms were correlated with changes in bacterial load in the treatment group (r=-0.89, p<0.0001). Individual estimates for decrements in the QOL-B RSS during exacerbation were -9.4 points (se 0.91) in ORBIT-3 and -10.8 points (0.74) in ORBIT-4 (both p<0.0001).Inhaled ARD-3150 resulted in significant improvements in respiratory symptoms during the on-treatment periods which were lost during off-treatment periods. These results supports the concept that reducing bacterial load can improve respiratory symptoms in patients with bronchiectasis.",2020,The proportion of patients achieving a symptom improvement above the minimum clinically important difference was higher with ARD-3150 compared to placebo during on-treatment cycles (p=0.024).,"['bronchiectasis', 'patients with bronchiectasis', 'patients with bronchiectasis and chronic  Pseudomonas aeruginosa  infection']","['ARD-3150', 'ARD-3150 (inhaled liposomal ciprofloxacin', 'Inhaled ARD-3150', 'placebo']","['proportion of patients achieving a symptom improvement', 'quality of life bronchiectasis respiratory symptom scale (QOL-B-RSS', 'respiratory symptoms']","[{'cui': 'C0006267', 'cui_str': 'Bronchiectasis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0033809', 'cui_str': 'Pseudomonas aeruginosa'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]","[{'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0023828', 'cui_str': 'Liposomes'}, {'cui': 'C0008809', 'cui_str': 'Ciprofloxacin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0006267', 'cui_str': 'Bronchiectasis'}, {'cui': 'C0037090', 'cui_str': 'Respiratory symptom'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0175693', 'cui_str': 'Russell-Silver syndrome'}]",,0.119268,The proportion of patients achieving a symptom improvement above the minimum clinically important difference was higher with ARD-3150 compared to placebo during on-treatment cycles (p=0.024).,"[{'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Chalmers', 'Affiliation': 'University of Dundee, Dundee, UK jchalmers@dundee.ac.uk.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cipolla', 'Affiliation': 'Insmed Incorporated, Bridgewater, NJ, USA.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Thompson', 'Affiliation': 'Theta Hat Statistical Consultants LLC, Owings Mills, MD, USA.'}, {'ForeName': 'Angela M', 'Initials': 'AM', 'LastName': 'Davis', 'Affiliation': 'Grifols, Research Triangle Park, NC, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': ""O'Donnell"", 'Affiliation': 'Georgetown University, Washington, DC, USA.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Tino', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Gonda', 'Affiliation': 'Aradigm Corporation, Hayward, CA, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Haworth', 'Affiliation': 'Royal Papworth Hospital and Department of Medicine, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Juergen', 'Initials': 'J', 'LastName': 'Froehlich', 'Affiliation': 'Aradigm Corporation, Hayward, CA, USA.'}]",The European respiratory journal,['10.1183/13993003.00110-2020']
1107,32546251,A comparison of two personalization and adaptive cognitive rehabilitation approaches: a randomized controlled trial with chronic stroke patients.,"BACKGROUND


Paper-and-pencil tasks are still widely used for cognitive rehabilitation despite the proliferation of new computer-based methods, like VR-based simulations of ADL's. Studies have established construct validity of VR assessment tools with their paper-and-pencil version by demonstrating significant associations with their traditional construct-driven measures. However, VR rehabilitation intervention tools are mostly developed to include mechanisms such as personalization and adaptation, elements that are disregarded in their paper-and-pencil counterparts, which is a strong limitation of comparison studies. Here we compare the clinical impact of a personalized and adapted paper-and-pencil training and a content equivalent and more ecologically valid VR-based ADL's simulation.
METHODS


We have performed a trial with 36 stroke patients comparing Reh@City v2.0 (adaptive cognitive training through everyday tasks VR simulations) with Task Generator (TG: content equivalent and adaptive paper-and-pencil training). The intervention comprised 12 sessions, with a neuropsychological assessment pre, post-intervention and follow-up, having as primary outcomes: general cognitive functioning (assessed by the Montreal Cognitive Assessment - MoCA), attention, memory, executive functions and language specific domains.
RESULTS


A within-group analysis revealed that the Reh@City v2.0 improved general cognitive functioning, attention, visuospatial ability and executive functions. These improvements generalized to verbal memory, processing speed and self-perceived cognitive deficits specific assessments. TG only improved in orientation domain on the MoCA, and specific processing speed and verbal memory outcomes. However, at follow-up, processing speed and verbal memory improvements were maintained, and a new one was revealed in language. A between-groups analysis revealed Reh@City v2.0 superiority in general cognitive functioning, visuospatial ability, and executive functions on the MoCA.
CONCLUSIONS


The Reh@City v2.0 intervention with higher ecological validity revealed higher effectiveness with improvements in different cognitive domains and self-perceived cognitive deficits in everyday life, and the TG intervention retained fewer cognitive gains for longer.
TRIAL REGISTRATION


The trial is registered at ClinicalTrials.gov, number NCT02857803. Registered 5 August 2016, .",2020,"A between-groups analysis revealed Reh@City v2.0 superiority in general cognitive functioning, visuospatial ability, and executive functions on the MoCA.
CONCLUSIONS


The Reh@City v2.0 intervention with higher ecological validity revealed higher effectiveness with improvements in different cognitive domains and self-perceived cognitive deficits in everyday life, and the TG intervention retained fewer cognitive gains for longer.
","['36 stroke patients comparing', 'chronic stroke patients']","['two personalization and adaptive cognitive rehabilitation approaches', 'Reh@City v2.0 (adaptive cognitive training through everyday tasks VR simulations) with Task Generator (TG: content equivalent and adaptive paper-and-pencil training', 'neuropsychological assessment pre, post-intervention and follow-up, having as primary outcomes: general cognitive functioning (assessed by the Montreal Cognitive Assessment - MoCA), attention, memory, executive functions and language specific domains', ""personalized and adapted paper-and-pencil training and a content equivalent and more ecologically valid VR-based ADL's simulation""]","['MoCA, and specific processing speed and verbal memory outcomes', 'general cognitive functioning, attention, visuospatial ability and executive functions', 'processing speed and verbal memory improvements', 'verbal memory, processing speed and self-perceived cognitive deficits specific assessments', 'cognitive gains', 'general cognitive functioning, visuospatial ability, and executive functions']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}]","[{'cui': 'C0870303', 'cui_str': 'Cognitive rehabilitation'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0441661', 'cui_str': 'Everyday tasks'}, {'cui': 'C0237638', 'cui_str': 'Generator'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0441059', 'cui_str': 'Pencil'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0025750', 'cui_str': ""3,3'-Dichloro-4,4'-Diaminodiphenylmethane""}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}]","[{'cui': 'C0025750', 'cui_str': ""3,3'-Dichloro-4,4'-Diaminodiphenylmethane""}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0582591', 'cui_str': 'Processing speed'}, {'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0009241', 'cui_str': 'Cognitive disorder'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",36.0,0.0444724,"A between-groups analysis revealed Reh@City v2.0 superiority in general cognitive functioning, visuospatial ability, and executive functions on the MoCA.
CONCLUSIONS


The Reh@City v2.0 intervention with higher ecological validity revealed higher effectiveness with improvements in different cognitive domains and self-perceived cognitive deficits in everyday life, and the TG intervention retained fewer cognitive gains for longer.
","[{'ForeName': 'Ana Lúcia', 'Initials': 'AL', 'LastName': 'Faria', 'Affiliation': 'Madeira Interactive Technologies Institute, Universidade da Madeira, Funchal, Portugal. ana.faria@m-iti.org.'}, {'ForeName': 'Maria Salomé', 'Initials': 'MS', 'LastName': 'Pinho', 'Affiliation': 'Faculdade de Psicologia e de Ciências da Educação, Universidade de Coimbra, Coimbra, Portugal.'}, {'ForeName': 'Sergi', 'Initials': 'S', 'LastName': 'Bermúdez I Badia', 'Affiliation': 'Madeira Interactive Technologies Institute, Universidade da Madeira, Funchal, Portugal.'}]",Journal of neuroengineering and rehabilitation,['10.1186/s12984-020-00691-5']
1108,32556876,Steroid Knee Injections for Arthritis Are No Better than Placebo in a Randomized Controlled Trial.,,2020,,[],"['Placebo', 'Steroid Knee Injections']",[],[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0187946', 'cui_str': 'Injection of knee joint'}]",[],,0.117495,,"[{'ForeName': 'Stephanie G', 'Initials': 'SG', 'LastName': 'Wheeler', 'Affiliation': 'Department of Medicine , University of Washington, Seattle, WA, USA. stephanie.wheeler@va.gov.'}]",Journal of general internal medicine,['10.1007/s11606-020-05647-y']
1109,32683460,Kirschner wire versus Herbert screw fixation for the treatment of unstable scaphoid waist fracture nonunion using corticocancellous iliac bone graft: randomized clinical trial.,"PURPOSE


The study compared the impact of the Kirschner wires versus Herbert screw fixation on the rate of union, time to union, correction of deformity, and clinical outcome in adults with unstable scaphoid waist fracture nonunions without avascular necrosis.
METHODS


We prospectively randomized 122 patients to undergo corticocancellous iliac bone grafting and internal fixation either with multiple Kirschner wires or Herbert screw. Radiographs, clinical outcome measures (pain, range of motion, and grip strength), and the Quick DASH score were taken pre- and post-operatively.
RESULTS


The rate of the scaphoid union in the Kirschner wire group was 91% versus 88% in the Herbert group. No difference was detected between the two groups with respect to the time to union, deformity correction, pain analysis, range of motion, grip strength, return to work, and complications.
CONCLUSION


Using of multiple Kirschner wires as a fixation method for unstable scaphoid waist fracture nonunion that was treated by open reduction and corticocancellous iliac bone grafting had a shorter operative time and lower cost as compared with the Herbert screw fixation. Herbert screw fixation was technically more demanding in terms of technique than K-wires. However, because of easy application of Kirschner wires, and low cost, especially in developing countries, it may be a good alternative to Herbert screw.",2020,"No difference was detected between the two groups with respect to the time to union, deformity correction, pain analysis, range of motion, grip strength, return to work, and complications.
","['unstable scaphoid waist fracture nonunion using corticocancellous iliac bone graft', 'adults with unstable scaphoid waist fracture nonunions without avascular necrosis', '122 patients to undergo']","['multiple Kirschner wires', 'Herbert screw fixation', 'corticocancellous iliac bone grafting and internal fixation either with multiple Kirschner wires or Herbert screw', 'Kirschner wires versus Herbert screw fixation', 'Kirschner wire versus Herbert screw fixation']","['Radiographs, clinical outcome measures (pain, range of motion, and grip strength), and the Quick DASH score', 'rate of the scaphoid union', 'rate of union, time to union, correction of deformity, and clinical outcome', 'time to union, deformity correction, pain analysis, range of motion, grip strength, return to work, and complications']","[{'cui': 'C0443343', 'cui_str': 'Unstable status'}, {'cui': 'C0448063', 'cui_str': 'Entire waist of scaphoid bone'}, {'cui': 'C0016665', 'cui_str': 'Fracture, ununited'}, {'cui': 'C0020889', 'cui_str': 'Bone structure of ilium'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0027543', 'cui_str': 'Avascular necrosis of bone'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0086510', 'cui_str': 'K-wire'}, {'cui': 'C0005975', 'cui_str': 'Bone screw'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0020889', 'cui_str': 'Bone structure of ilium'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0016642', 'cui_str': 'Internal fixation of fracture'}]","[{'cui': 'C1306645', 'cui_str': 'Plain radiography'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0223724', 'cui_str': 'Bone structure of scaphoid'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0425105', 'cui_str': 'Returned to work'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",122.0,0.0353334,"No difference was detected between the two groups with respect to the time to union, deformity correction, pain analysis, range of motion, grip strength, return to work, and complications.
","[{'ForeName': 'Galal', 'Initials': 'G', 'LastName': 'Hegazy', 'Affiliation': 'Orthopedic Department, Faculty of Medicine, AL-Azhar University, Nasr City, Cairo, 11884, Egypt. glalhegazy@azhar.edu.eg.'}, {'ForeName': 'Ehab', 'Initials': 'E', 'LastName': 'Alshal', 'Affiliation': 'Orthopedic Department, Faculty of Medicine, AL-Azhar University, Assiut, 71524, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Abdelaal', 'Affiliation': 'Orthopedic Department, Faculty of Medicine, AL-Azhar University, Nasr City, Cairo, 11884, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Abdelaziz', 'Affiliation': 'Orthopedic Department, Faculty of Medicine, AL-Azhar University, Nasr City, Cairo, 11884, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Moawad', 'Affiliation': 'Orthopedic Department, Faculty of Medicine, AL-Azhar University, Nasr City, Cairo, 11884, Egypt.'}, {'ForeName': 'Yasser M', 'Initials': 'YM', 'LastName': 'Saqr', 'Affiliation': 'Orthopedic Department, Faculty of Medicine, Port Said University, Port Said, 11884, Egypt.'}, {'ForeName': 'Ibrahem', 'Initials': 'I', 'LastName': 'El-Sebaey', 'Affiliation': 'Orthopedic Department, Faculty of Medicine, AL-Azhar University, Nasr City, Cairo, 11884, Egypt.'}, {'ForeName': 'Mokhtar', 'Initials': 'M', 'LastName': 'Abdelazeem', 'Affiliation': 'Orthopedic Department, Faculty of Medicine, AL-Azhar University, Nasr City, Cairo, 11884, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'El-Barody', 'Affiliation': 'Radiodiagnosis Department, South Egypt Cancer Institute, Assiut University, Assiut, 71524, Egypt.'}]",International orthopaedics,['10.1007/s00264-020-04730-7']
1110,32544297,Long-term safety and efficacy of N8-GP in previously treated adults and adolescents with hemophilia A: Final results from pathfinder2.,"BACKGROUND


N8-GP (turoctocog alfa pegol; Esperoct ®  , Novo Nordisk A/S, Bagsvaerd, Denmark) is a glycoPEGylated human recombinant factor VIII with a half-life of ~1.6-fold of standard FVIII products. pathfinder2 (NCT01480180) was a multi-national, open-label trial of N8-GP in previously treated adolescent and adult patients with severe hemophilia A.
OBJECTIVE


We report end-of-trial efficacy and safety of N8-GP from pathfinder2.
METHODS


pathfinder2 main phase and extension phase part 1 results have been previously reported. During extension phase part 2, patients could switch from N8-GP prophylaxis 50 IU/kg every fourth day (Q4D) or 75 IU/kg once weekly (Q7D), depending on bleeding status. Extension phase part 2 collected long-term safety and efficacy data for all regimens until trial end (first patient in main phase, 30 January 2012; trial end, 10 December 2018).
RESULTS


Overall, 186 patients were exposed to N8-GP for up to 6.6 years (median 5.4 years). The estimated annualized bleeding rate (ABR) was 2.14 (median 0.84) for the Q4D prophylaxis arm and 1.31 (median 1.67) for the Q7D prophylaxis arm. Nearly 30% of patients experienced zero bleeds throughout the entire duration of the trial, the hemostatic response was 83.2% across all treatment arms, and patient-reported outcomes were maintained or slightly improved. No safety concerns were detected.
CONCLUSION


Data from the completed pathfinder2 trial, one of the largest and longest-running clinical trials to investigate treatment of severe hemophilia A, demonstrate the efficacy and safety of N8-GP in previously treated adolescent and adult patients.",2020,The estimated annualized bleeding rate (ABR) was 2.14 (median 0.84) for the Q4D prophylaxis arm and 1.31 (median 1.67) for the Q7D prophylaxis arm.,"['previously treated adults and adolescents with hemophilia A', 'previously treated adolescent and adult patients', '186 patients were exposed to N8-GP for up to 6.6\xa0years (median 5.4\xa0years', 'previously treated adolescent and adult patients with severe hemophilia A']",['N8-GP'],"['hemostatic response', 'annualized bleeding rate (ABR']","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0019069', 'cui_str': 'Hereditary factor VIII deficiency disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C4517823', 'cui_str': '6.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C4517792', 'cui_str': '5.4'}, {'cui': 'C0272322', 'cui_str': 'Severe hereditary factor VIII deficiency disease'}]",[],"[{'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",186.0,0.0938106,The estimated annualized bleeding rate (ABR) was 2.14 (median 0.84) for the Q4D prophylaxis arm and 1.31 (median 1.67) for the Q7D prophylaxis arm.,"[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Giangrande', 'Affiliation': 'Department of Clinical and Laboratory Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Faraizah', 'Initials': 'F', 'LastName': 'Abdul Karim', 'Affiliation': 'National Blood Centre, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Laszlo', 'Initials': 'L', 'LastName': 'Nemes', 'Affiliation': 'National Hemophilia Center and Hemostasis Department, Medical Center of the Hungarian Defence Forces, Budapest, Hungary.'}, {'ForeName': 'Chur Woo', 'Initials': 'CW', 'LastName': 'You', 'Affiliation': 'Pediatric Department, Eulji University Hospital, Daejeon, Korea.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Landorph', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Milan S', 'Initials': 'MS', 'LastName': 'Geybels', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Curry', 'Affiliation': 'Oxford Haemophilia and Thrombosis Centre and Oxford National Institute for Health Research Biomedical Research Centre, Churchill Hospital, Oxford, UK.'}]",Journal of thrombosis and haemostasis : JTH,['10.1111/jth.14959']
1111,32556249,Psychosocial Mechanisms of Cognitive-Behavioral-Based Physical Therapy Outcomes After Spine Surgery: Preliminary Findings From Mediation Analyses.,"OBJECTIVE


Changing Behavior through Physical Therapy (CBPT), a cognitive-behavioral-based program, has been shown to improve outcomes after lumbar spine surgery in patients with a high psychosocial risk profile; however, little is known about potential mechanisms associated with CBPT treatment effects. The purpose of this study was to explore potential mediators underlying CBPT efficacy after spine surgery.
METHODS


In this secondary analysis, 86 participants were enrolled in a randomized trial comparing a postoperative CBPT (n = 43) and education program (n = 43). Participants completed validated questionnaires at 6 weeks (baseline) and 3 and 6 months following surgery for back pain (Brief Pain Inventory), disability (Oswestry Disability Index), physical health (12-Item Short-Form Health Survey), fear of movement (Tampa Scale for Kinesiophobia), pain catastrophizing (Pain Catastrophizing Scale), and pain self-efficacy (Pain Self-Efficacy Questionnaire). Parallel multiple mediation analyses using Statistical Package for the Social Sciences (SPSS) were conducted to examine whether 3- and 6-month changes in fear of movement, pain catastrophizing, and pain self-efficacy mediate treatment outcome effects at 6 months.
RESULTS


Six-month changes, but not 3-month changes, in fear of movement and pain self-efficacy mediated postoperative outcomes at 6 months. Specifically, changes in fear of movement mediated the effects of CBPT treatment on disability (indirect effect = -2.0 [95% CI = -4.3 to 0.3]), whereas changes in pain self-efficacy mediated the effects of CBPT treatment on physical health (indirect effect = 3.5 [95% CI = 1.2 to 6.1]).
CONCLUSIONS


This study advances evidence on potential mechanisms underlying cognitive-behavioral strategies. Future work with larger samples is needed to establish whether these factors are a definitive causal mechanism.
IMPACT


Fear of movement and pain self-efficacy may be important mechanisms to consider when developing and testing psychologically informed physical therapy programs.",2020,"[95% CI = -4.3 to 0.3]), whereas changes in pain self-efficacy mediated the effects of CBPT treatment on physical health (indirect effect = 3.5","['86 participants', 'patients with a high psychosocial risk profile', 'After Spine Surgery']","['Physical Therapy (CBPT', 'Cognitive-Behavioral-Based Physical Therapy Outcomes', 'CBPT', 'postoperative CBPT', 'education program']","['back pain (Brief Pain Inventory), disability (Oswestry Disability Index), physical health (SF-12), fear of movement (Tampa Scale of Kinesiophobia', 'fear of movement and pain self-efficacy mediated postoperative outcomes', 'pain catastrophizing (Pain Catastrophizing Scale), and pain self-efficacy (Pain Self-Efficacy Questionnaire', 'pain self-efficacy', 'physical health', 'fear of movement, pain catastrophizing, and pain self-efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0920347', 'cui_str': 'Procedure on spinal cord'}]","[{'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}]","[{'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}, {'cui': 'C4075347', 'cui_str': 'Pain Self-efficacy Questionnaire'}]",86.0,0.044694,"[95% CI = -4.3 to 0.3]), whereas changes in pain self-efficacy mediated the effects of CBPT treatment on physical health (indirect effect = 3.5","[{'ForeName': 'Rogelio A', 'Initials': 'RA', 'LastName': 'Coronado', 'Affiliation': 'Department of Orthopaedic Surgery, Department of Physical Medicine and Rehabilitation, and Center for Musculoskeletal Research, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Dawn M', 'Initials': 'DM', 'LastName': 'Ehde', 'Affiliation': 'Department of Rehabilitation Medicine, University of Washington, Seattle, Washington.'}, {'ForeName': 'Jacquelyn S', 'Initials': 'JS', 'LastName': 'Pennings', 'Affiliation': 'Department of Orthopaedic Surgery, and Center for Musculoskeletal Research, Vanderbilt University Medical Center.'}, {'ForeName': 'Susan W', 'Initials': 'SW', 'LastName': 'Vanston', 'Affiliation': 'Department of Orthopaedic Surgery, Vanderbilt University Medical Center.'}, {'ForeName': 'Tatsuki', 'Initials': 'T', 'LastName': 'Koyama', 'Affiliation': 'Department of Biostatistics, Vanderbilt University Medical Center.'}, {'ForeName': 'Sharon E', 'Initials': 'SE', 'LastName': 'Phillips', 'Affiliation': 'Department of Biostatistics, Vanderbilt University Medical Center.'}, {'ForeName': 'Shannon L', 'Initials': 'SL', 'LastName': 'Mathis', 'Affiliation': 'Department of Kinesiology, University of Alabama, Huntsville, Alabama.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'McGirt', 'Affiliation': 'Carolina Neurosurgery and Spine Associates, Charlotte, North Carolina.'}, {'ForeName': 'Dan M', 'Initials': 'DM', 'LastName': 'Spengler', 'Affiliation': 'Department of Orthopaedic Surgery, Vanderbilt University Medical Center.'}, {'ForeName': 'Oran S', 'Initials': 'OS', 'LastName': 'Aaronson', 'Affiliation': 'Howell Allen Clinic, Saint Thomas Medical Partners, Nashville, Tennessee.'}, {'ForeName': 'Joseph S', 'Initials': 'JS', 'LastName': 'Cheng', 'Affiliation': 'Department of Neurosurgery, University of Cincinnati School of Medicine, Cincinnati, Ohio.'}, {'ForeName': 'Clinton J', 'Initials': 'CJ', 'LastName': 'Devin', 'Affiliation': 'Department of Orthopaedic Surgery, Vanderbilt University Medical Center; and Steamboat Orthopaedic and Spine Institute, Steamboat Springs, Colorado.'}, {'ForeName': 'Stephen T', 'Initials': 'ST', 'LastName': 'Wegener', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Johns Hopkins Medicine, Baltimore, Maryland.'}, {'ForeName': 'Kristin R', 'Initials': 'KR', 'LastName': 'Archer', 'Affiliation': 'Department of Orthopaedic Surgery, Center for Musculoskeletal Research, Vanderbilt University Medical Center, 1215 21st Avenue S, Medical Center East - South Tower, Suite 4200, Nashville, TN 37232 (USA); Department of Physical Medicine and Rehabilitation, Osher Center for Integrative Medicine, Vanderbilt University Medical Center.'}]",Physical therapy,['10.1093/ptj/pzaa112']
1112,32554025,swCRTdesign: An RPackage for Stepped Wedge Trial Design and Analysis.,"BACKGROUND AND OBJECTIVE


Stepped wedge trials (SWTs) are a type of cluster-randomized trial that are commonly used to evaluate health care interventions. Most SWT-related software packages have restrictive assumptions about the study design and correlation structure of the data. The objective of this paper is to present a package and corresponding web-based graphical user interface (GUI) that provide researchers with another, more flexible option for SWT design and analysis.
METHODS


We developed an Rpackage swCRTdesign ('stepped wedge Cluster Randomized Trial design'), which uses a random effects model to account for correlation in the data induced by a SWT design. Possible sources of correlation include clusters, time within clusters, and treatment within clusters.
RESULTS


swCRTdesign allows a user to calculate power, simulate SWT data to streamline simulation studies (e.g. to estimate power), and create descriptive summaries and plots. Additionally, a GUI, developed using shiny, is available to calculate power and create power curves and design plots.
CONCLUSIONS


The swCRTdesign package accommodates a wide variety of SWT designs, and makes it easy to account for some sources of correlation which are not found in other packages. The user-friendly web-based GUI makes some swCRTdesign features accessible to researchers not familiar with R. These two resources will make appropriately complex SWT calculations more accessible to scientists from a wide variety of backgrounds.",2020,"We developed an R package swCRTdesign ('stepped wedge Cluster Randomized Trial design'), which uses a random effects model to account for correlation in the data induced by a SWT design.",[],['swCRTdesign'],[],[],[],[],,0.150645,"We developed an R package swCRTdesign ('stepped wedge Cluster Randomized Trial design'), which uses a random effects model to account for correlation in the data induced by a SWT design.","[{'ForeName': 'Emily C', 'Initials': 'EC', 'LastName': 'Voldal', 'Affiliation': 'Department of Biostatistics, University of Washington, Box 357232, Seattle, WA 98195, United States. Electronic address: voldal@uw.edu.'}, {'ForeName': 'Navneet R', 'Initials': 'NR', 'LastName': 'Hakhu', 'Affiliation': 'Department of Statistics, University of California, Irvine, Irvine, CA 92697, United States.'}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Xia', 'Affiliation': 'Department of Biostatistics, University of Washington, Box 357232, Seattle, WA 98195, United States.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Heagerty', 'Affiliation': 'Department of Biostatistics, University of Washington, Box 357232, Seattle, WA 98195, United States.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Hughes', 'Affiliation': 'Department of Biostatistics, University of Washington, Box 357232, Seattle, WA 98195, United States.'}]",Computer methods and programs in biomedicine,['10.1016/j.cmpb.2020.105514']
1113,32568092,An Intervention Delivered by Mobile Phone Instant Messaging to Increase Acceptability and Use of Effective Contraception Among Young Women in Bolivia: Randomized Controlled Trial.,"BACKGROUND


Although the most effective methods of contraception are available in Bolivia, unmet need for contraception among women aged 15 to 19 years is estimated to be 38% (2008), and the adolescent fertility rate is 71 per 1000 women (2016). Mobile phones are a popular mode to deliver health behavior support. We developed a contraceptive behavioral intervention for young Bolivian women delivered by mobile phone and guided by behavioral science. The intervention consists of short instant messages sent through an app over 4 months.
OBJECTIVE


This trial aimed to evaluate the effect of the intervention on young Bolivian women's use of and attitudes toward the effective contraceptive methods available in Bolivia.
METHODS


This was a parallel group, individually randomized superiority trial with a 1:1 allocation ratio. Women were eligible if they were aged 16 to 24 years, owned a personal Android mobile phone, lived in La Paz or El Alto, reported an unmet need for contraception, and could read Spanish. The target sample size was 1310 participants. Participants allocated to the intervention had access to an app with standard family planning information and intervention messages. Participants allocated to the control group had access to the same app and control messages. Coprimary outcomes were use of effective contraception and acceptability of at least one method of effective contraception at 4 months. Secondary outcomes were use of effective contraception during the study, acceptability of the individual methods, service uptake, unintended pregnancy, and abortion. Process outcomes included knowledge, perceived norms, personal agency, and intention. Outcomes were analyzed using logistic and linear regression. We also asked participants about physical violence.
RESULTS


A total of 640 participants were enrolled, and 67.0% (429) of them contributed follow-up data for the coprimary outcome, the use of effective contraception. There was no evidence that use differed between the groups (33% control vs 37% intervention; adjusted odds ratio [OR] 1.19, 95% CI 0.80 to 1.77; P=.40). There was a borderline significant effect regarding acceptability (63% control vs 72% intervention; adjusted OR 1.49, 95% CI 0.98 to 2.28; P=.06). There were no statistically significant differences in any of the secondary or process outcomes. The intervention dose received was low. In the control group, 2.8% (6/207) reported experiencing physical violence compared with 1.9% (4/202) in the intervention group (Fisher exact test P=.75).
CONCLUSIONS


This trial was unable to provide definitive conclusions regarding the effect of the intervention on use and acceptability of effective contraception because of under recruitment. Although we cannot strongly recommend implementation, the results suggest that it would be safe and may increase the acceptability of effective contraception if the intervention messages were offered alongside the download of the app.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02905526; https://clinicaltrials.gov/ct2/show/NCT02905526.",2020,"There was a borderline significant effect regarding acceptability (63% control vs 72% intervention; adjusted OR 1.49, 95% CI 0.98 to 2.28; P=.06).","['1310 participants', 'women aged 15 to 19 years is estimated to be 38% (2008), and the adolescent fertility rate is 71 per 1000 women (2016', 'A total of 640 participants were enrolled, and 67.0% (429) of them contributed follow-up data for the coprimary outcome, the use of effective contraception', 'Women were eligible if they were aged 16 to 24 years, owned a personal Android mobile phone, lived in La Paz or El Alto, reported an unmet need for contraception, and could read Spanish', 'Young Women in Bolivia', ""young Bolivian women's"", 'young Bolivian women delivered by', 'participants about physical violence']","['intervention had access to an app with standard family planning information and intervention messages', 'control group had access to the same app and control messages', 'Mobile Phone Instant Messaging', 'mobile phone and guided by behavioral science', 'contraceptive behavioral intervention']","['acceptability', 'experiencing physical violence', 'acceptability of effective contraception', 'effective contraception and acceptability of at least one method of effective contraception', 'knowledge, perceived norms, personal agency, and intention', 'effective contraception during the study, acceptability of the individual methods, service uptake, unintended pregnancy, and abortion']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0015912', 'cui_str': 'Fertility Rate'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4708790', 'cui_str': '640'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0700589', 'cui_str': 'Contraception'}, {'cui': 'C0336541', 'cui_str': 'Android'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1277145', 'cui_str': 'Reads Spanish'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0005918', 'cui_str': 'Bolivia'}, {'cui': 'C0476480', 'cui_str': 'Physical violence'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009861', 'cui_str': 'Family planning service'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0004940', 'cui_str': 'Behavioral Sciences'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0476480', 'cui_str': 'Physical violence'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0700589', 'cui_str': 'Contraception'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0237750', 'cui_str': 'Societal Norms'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0041747', 'cui_str': 'Unplanned pregnancy'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}]",640.0,0.278254,"There was a borderline significant effect regarding acceptability (63% control vs 72% intervention; adjusted OR 1.49, 95% CI 0.98 to 2.28; P=.06).","[{'ForeName': 'Ona L', 'Initials': 'OL', 'LastName': 'McCarthy', 'Affiliation': 'The London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Aliaga', 'Affiliation': 'CIES Salud Sexual Salud Reproductiva, La Paz, Bolivia.'}, {'ForeName': 'Maria Eugenia', 'Initials': 'ME', 'LastName': 'Torrico Palacios', 'Affiliation': 'CIES Salud Sexual Salud Reproductiva, La Paz, Bolivia.'}, {'ForeName': 'Jhonny', 'Initials': 'J', 'LastName': 'López Gallardo', 'Affiliation': 'CIES Salud Sexual Salud Reproductiva, La Paz, Bolivia.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Huaynoca', 'Affiliation': 'International Planned Parenthood Federation/Western Hemisphere Region, New York, NY, United States.'}, {'ForeName': 'Baptiste', 'Initials': 'B', 'LastName': 'Leurent', 'Affiliation': 'The London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Phil', 'Initials': 'P', 'LastName': 'Edwards', 'Affiliation': 'The London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Palmer', 'Affiliation': 'The London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Irrfan', 'Initials': 'I', 'LastName': 'Ahamed', 'Affiliation': 'The London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Free', 'Affiliation': 'The London School of Hygiene and Tropical Medicine, London, United Kingdom.'}]",Journal of medical Internet research,['10.2196/14073']
1114,32564340,A Comparison of Ezetimibe and Evolocumab for Atherogenic Lipid Reduction in Four Patient Populations: A Pooled Efficacy and Safety Analysis of Three Phase 3 Studies.,"INTRODUCTION


Clinicians, payers, guideline committees, and policymakers support the use of high-intensity statins in patients at high risk for complications of cardiovascular disease (CVD). Guidelines and recommendations provide guidance on next steps for patients with inadequate low-density lipoprotein cholesterol (LDL-C) control on maximally tolerated statin or for those who are statin-intolerant. Ezetimibe and evolocumab improve CV outcomes when added to statins in high-CV-risk populations. The aim of the study was to compare evolocumab and ezetimibe for lipid-lowering efficacy and safety.
METHODS


We summarized data from 1427 patients from three phase 3 evolocumab studies comparing double-blinded evolocumab vs. ezetimibe. These studies evaluated four distinct populations: those free of CVD receiving each agent as monotherapy, patients with CVD receiving add-on therapy to low- or high-intensity statin, and statin-intolerant patients. Lipid efficacy and safety were reported at week 12.
RESULTS


Across the studies, evolocumab reduced LDL-C by a mean 55-61% from baseline to week 12; ezetimibe lowered LDL-C by 18-20% from baseline (mean difference = 38-43% favoring evolocumab; p < 0.0001). This corresponded to absolute reductions in LDL-C of 60-104 mg/dL with evolocumab vs. 17-35 mg/dL with ezetimibe. Evolocumab also significantly improved other lipids and led to a higher percentage of patients achieving LDL-C goals vs. ezetimibe. Adverse events and discontinuation rates (oral and parenteral therapy) were balanced across groups, suggesting good tolerance and acceptance of both treatments.
CONCLUSIONS


Evolocumab outperformed ezetimibe in efficacy and lipid goal attainment. Both products demonstrated good safety/tolerability. These data may help guide access decisions for high-risk patients with inadequate treatment response or intolerance to statin therapy.",2020,"Across the studies, evolocumab reduced LDL-C by a mean 55-61% from baseline to week 12; ezetimibe lowered LDL-C by 18-20% from baseline (mean difference = 38-43% favoring evolocumab; p < 0.0001).","['patients with CVD receiving add-on therapy to low- or high-intensity statin, and statin-intolerant patients', 'patients with inadequate low-density lipoprotein cholesterol (LDL-C) control on maximally tolerated statin or for those who are statin-intolerant', 'patients at high risk for complications of cardiovascular disease (CVD', 'Four Patient Populations', 'high-risk patients with inadequate treatment response or intolerance to statin therapy', '1427 patients from three phase 3 evolocumab studies comparing double-blinded']","['ezetimibe', 'evolocumab and ezetimibe', 'evolocumab vs. ezetimibe', 'Ezetimibe and evolocumab', 'Ezetimibe and Evolocumab']","['CV outcomes', 'Lipid efficacy and safety', 'good safety/tolerability', 'LDL-C', 'Adverse events and discontinuation rates (oral and parenteral therapy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0231199', 'cui_str': 'Intolerance'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C3529352', 'cui_str': 'evolocumab'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}]","[{'cui': 'C1142985', 'cui_str': 'ezetimibe'}, {'cui': 'C3529352', 'cui_str': 'evolocumab'}]","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0030547', 'cui_str': 'Parenteral nutrition'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]",1427.0,0.170858,"Across the studies, evolocumab reduced LDL-C by a mean 55-61% from baseline to week 12; ezetimibe lowered LDL-C by 18-20% from baseline (mean difference = 38-43% favoring evolocumab; p < 0.0001).","[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Koren', 'Affiliation': 'Jacksonville Center for Clinical Research, 4085 University Blvd. South, Suite 1, Jacksonville, FL, 32216, USA. mkoren@encoredocs.com.'}, {'ForeName': 'Peter H', 'Initials': 'PH', 'LastName': 'Jones', 'Affiliation': 'Baylor College of Medicine, 6655 Travis St., Suite 320, Houston, TX, 77030, USA.'}, {'ForeName': 'Jennifer G', 'Initials': 'JG', 'LastName': 'Robinson', 'Affiliation': 'University of Iowa, 145 N. Riverside Dr, Iowa City, IA, 52246, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Sullivan', 'Affiliation': 'Department of Clinical Biochemistry, Royal Prince Alfred Hospital, 50 Missenden Rd, Camperdown, NSW, 2050, Australia.'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Cho', 'Affiliation': 'Cleveland Clinic, 9500 Euclid Ave., Desk JB1, Cleveland, OH, 44195, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hucko', 'Affiliation': 'Amgen Inc, One Amgen Center Drive, Thousand Oaks, CA, 91320, USA.'}, {'ForeName': 'J Antonio G', 'Initials': 'JAG', 'LastName': 'Lopez', 'Affiliation': 'Amgen Inc, One Amgen Center Drive, Thousand Oaks, CA, 91320, USA.'}, {'ForeName': 'Alex N', 'Initials': 'AN', 'LastName': 'Fleishman', 'Affiliation': 'Amgen Inc, One Amgen Center Drive, Thousand Oaks, CA, 91320, USA.'}, {'ForeName': 'Ransi', 'Initials': 'R', 'LastName': 'Somaratne', 'Affiliation': 'Amgen Inc, One Amgen Center Drive, Thousand Oaks, CA, 91320, USA.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Stroes', 'Affiliation': 'Academic Medical Center of Amsterdam, Meibergdreef 9, 1105 AZ Amsterdam-Zuidoost, Amsterdam, The Netherlands.'}]",Cardiology and therapy,['10.1007/s40119-020-00181-8']
1115,32568651,Theophylline as an Add-On to Thrombolytic Therapy in Acute Ischemic Stroke: A Randomized Placebo-Controlled Trial.,"BACKGROUND AND PURPOSE


Delayed recanalization increases the risk of infarct growth and poor clinical outcome in acute ischemic stroke. The vasoactive agent theophylline has shown neuroprotective effects in animal stroke models but inconclusive results in case series and randomized clinical trials. The primary objective of this study was to evaluate whether theophylline, as an add-on to thrombolytic therapy, is safe and effective in acute ischemic stroke patients.
METHODS


The TEA-Stroke trial (The Theophylline in Acute Ischemic Stroke) was an investigator-initiated 2-center, proof-of-concept, phase II clinical study with a randomized, double-blinded, placebo-controlled design. The main inclusion criteria were magnetic resonance imaging-verified acute ischemic stroke, moderate to severe neurological deficit (National Institutes of Health Stroke Scale score of ≥4), and treatment with thrombolysis within 4.5 hours of onset. Participants were randomly assigned in the ratio 1:1 to either 220 mg of intravenous theophylline or placebo. The co-primary outcomes were early clinical improvement on the National Institutes of Health Stroke Scale score and infarct growth on magnetic resonance imaging at 24-hour follow-up.
RESULTS


Theophylline as an add-on to thrombolytic therapy improved the National Institutes of Health Stroke Scale score at 24 hours by mean 4.7 points (SD, 5.6) compared with an improvement of 1.3 points (SD, 7.5) in the control group ( P =0.044). Mean infarct growth was 141.6% (SD, 126.5) and 104.1% (SD, 62.5) in the theophylline and control groups, respectively ( P =0.146). Functional independence at 90 days was 61% in the theophylline group and 58% in the control group ( P =0.802).
CONCLUSIONS


This proof-of-concept trial investigated theophylline administration as an add-on to thrombolytic therapy in acute ischemic stroke. The co-primary end points early clinical improvement and infarct growth at 24-hour follow-up were not significantly different after post hoc correction for multiplicity (Bonferroni technique). The small study size precludes a conclusion as to whether theophylline has a neuroprotective effect but provides a promising clinical signal that may support a future clinical trial. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: EudraCT number 2013-001989-42.",2020,The co-primary end points early clinical improvement and infarct growth at 24-hour follow-up were not significantly different after post hoc correction for multiplicity (Bonferroni technique).,"['acute ischemic stroke', 'acute ischemic stroke patients', 'Acute Ischemic Stroke', 'acute ischemic stroke, moderate to severe neurological deficit (National Institutes of Health Stroke Scale score of ≥4), and treatment with thrombolysis within 4.5 hours of onset']","['Placebo', 'vasoactive agent theophylline', 'Theophylline', 'theophylline or placebo', 'theophylline', 'placebo']","['Mean infarct growth', 'Functional independence', 'National Institutes of Health Stroke Scale score and infarct growth on magnetic resonance imaging at 24-hour follow-up', 'infarct growth', 'National Institutes of Health Stroke Scale score']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0521654', 'cui_str': 'Motor dysfunction'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C3844009', 'cui_str': '4.5'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0039771', 'cui_str': 'Theophylline'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]",,0.545742,The co-primary end points early clinical improvement and infarct growth at 24-hour follow-up were not significantly different after post hoc correction for multiplicity (Bonferroni technique).,"[{'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Modrau', 'Affiliation': 'Departments of Neurology (B.M., F.W.B.), Aalborg University Hospital, Denmark.'}, {'ForeName': 'Grethe', 'Initials': 'G', 'LastName': 'Andersen', 'Affiliation': 'Departments of Neurology (G.A., N.H.), Aarhus University Hospital, Denmark.'}, {'ForeName': 'Irene Klærke', 'Initials': 'IK', 'LastName': 'Mikkelsen', 'Affiliation': 'Centre of Functionally Integrative Neuroscience, Aarhus University, Denmark (I.K.M., A.N., M.B.H., K.M., L.Ø.).'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Nielsen', 'Affiliation': 'Centre of Functionally Integrative Neuroscience, Aarhus University, Denmark (I.K.M., A.N., M.B.H., K.M., L.Ø.).'}, {'ForeName': 'Mikkel Bo', 'Initials': 'MB', 'LastName': 'Hansen', 'Affiliation': 'Centre of Functionally Integrative Neuroscience, Aarhus University, Denmark (I.K.M., A.N., M.B.H., K.M., L.Ø.).'}, {'ForeName': 'Martin Berg', 'Initials': 'MB', 'LastName': 'Johansen', 'Affiliation': 'Unit of Clinical Biostatistics (M.B.J.), Aalborg University Hospital, Denmark.'}, {'ForeName': 'Helle Wulf', 'Initials': 'HW', 'LastName': 'Eskildsen', 'Affiliation': 'Neuroradiology (H.W.E., J.P.P., Y.Y.), Aalborg University Hospital, Denmark.'}, {'ForeName': 'Jan Plougmann', 'Initials': 'JP', 'LastName': 'Povlsen', 'Affiliation': 'Neuroradiology (H.W.E., J.P.P., Y.Y.), Aalborg University Hospital, Denmark.'}, {'ForeName': 'Yousef', 'Initials': 'Y', 'LastName': 'Yavarian', 'Affiliation': 'Neuroradiology (H.W.E., J.P.P., Y.Y.), Aalborg University Hospital, Denmark.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Mouridsen', 'Affiliation': 'Centre of Functionally Integrative Neuroscience, Aarhus University, Denmark (I.K.M., A.N., M.B.H., K.M., L.Ø.).'}, {'ForeName': 'Leif', 'Initials': 'L', 'LastName': 'Østergaard', 'Affiliation': 'Neuroradiology (L.Ø.), Aarhus University Hospital, Denmark.'}, {'ForeName': 'Flemming Winther', 'Initials': 'FW', 'LastName': 'Bach', 'Affiliation': 'Departments of Neurology (B.M., F.W.B.), Aalborg University Hospital, Denmark.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Hjort', 'Affiliation': 'Departments of Neurology (G.A., N.H.), Aarhus University Hospital, Denmark.'}]",Stroke,['10.1161/STROKEAHA.119.027446']
1116,32578404,Modification of Affective Trajectory in a Positive Psychology Intervention.,"Enhancing positive affect (PA) and reducing negative affect (NA) are targets of positive psychology interventions, and well-being and positive functioning are core elements of mental health. However, the underlying temporal dynamics of these elements are unknown. This study aimed at identifying how a 42-day daily positive psychology intervention (PPI) impacts affective longitudinal dynamics compared to a control condition. This study employed an experience sampling method (self-observation diary including the Measurement of Affectivity: Valence/Activation scale, MAVA) with two non-randomised groups-a control group (n = 43) and an intervention group (n = 43)-taken from a community sample. Compared to the control participants, the PPI participants' trajectories for activated and deactivated NA showed an important decrease over the course of the PPI. The deactivated PA trajectory increased non-linearly across the PPI, whereas the activated PA trajectory showed a linear increase. This study suggests that PPIs change daily affective life.",2020,"Compared to the control participants, the PPI participants' trajectories for activated and deactivated NA showed an important decrease over the course of the PPI.",[],"['42-day daily positive psychology intervention (PPI', 'intervention group (n\xa0']","['deactivated PA trajectory', 'PPIs change daily affective life']",[],"[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1510628', 'cui_str': 'Positive Psychology'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}]",43.0,0.0211071,"Compared to the control participants, the PPI participants' trajectories for activated and deactivated NA showed an important decrease over the course of the PPI.","[{'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Congard', 'Affiliation': 'Nantes University, Laboratoire de Psychologie des Pays de la Loire, LPPL, EA 4638, Nantes, France.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Andreotti', 'Affiliation': 'University of Lille, CNRS, UMR 9193 - SCALab - Sciences Cognitives et Sciences Affectives, Lille, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Dauvier', 'Affiliation': 'Center for Research on the Psychology of Cognition, Langage and Emotion, Aix-Marseille University, Aix-en-Provence, France.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Le Vigouroux', 'Affiliation': 'University of Nimes, EA 7352, CHROME, Nîmes Cedex 01, France.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Antoine', 'Affiliation': 'University of Lille, CNRS, UMR 9193 - SCALab - Sciences Cognitives et Sciences Affectives, Lille, France.'}]",Applied psychology. Health and well-being,['10.1111/aphw.12206']
1117,32544794,Acute aerobic exercise enhances pleasant compared to unpleasant visual scene processing.,"Although acute aerobic exercise benefits different aspects of emotional functioning, it is unclear how exercise influences the processing of emotional stimuli and which brain mechanisms support this relationship. We assessed the influence of acute aerobic exercise on valence biases (preferential processing of negative/positive pictures) by performing source reconstructions of participants' brain activity after they viewed emotional scenes. Twenty-four healthy participants (12 women) were tested in a randomized and counterbalanced design that consisted of three experimental protocols, each lasting 30 min: low-intensity exercise (Low-Int); moderate-intensity exercise (Mod-Int); and a seated rest condition (REST). After each of the protocols, participants viewed negative and positive pictures, during which event-related magnetic fields were recorded. Analyses revealed that exercise strongly impacted the valence processing of emotional scenes within a widely distributed left hemispheric spatio-temporal cluster between 190 and 310 ms after picture onset. Brain activity in this cluster showed that a negativity bias at REST (negative > positive picture processing) diminished after the Low-Int condition (positive = negative) and even reversed to a positivity bias after the Mod-Int condition (positive > negative). Thus, acute aerobic exercise of low and moderate intensities induces a positivity bias which is reflected in early, automatic processes.",2020,Analyses revealed that exercise strongly impacted the valence processing of emotional scenes within a widely distributed left hemispheric spatio-temporal cluster between 190 and 310 ms after picture onset.,"['Twenty-four healthy participants (12 women', ""participants' brain activity after they viewed emotional scenes""]","['Acute aerobic exercise enhances pleasant', 'lasting 30\xa0min: low-intensity exercise (Low-Int); moderate-intensity exercise (Mod-Int); and a seated rest condition (REST', 'acute aerobic exercise']","['valence processing of emotional scenes', 'Brain activity']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0443158', 'cui_str': 'Brain activity'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0277814', 'cui_str': 'Sitting position'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0443158', 'cui_str': 'Brain activity'}]",24.0,0.139816,Analyses revealed that exercise strongly impacted the valence processing of emotional scenes within a widely distributed left hemispheric spatio-temporal cluster between 190 and 310 ms after picture onset.,"[{'ForeName': 'Tomasz S', 'Initials': 'TS', 'LastName': 'Ligeza', 'Affiliation': 'Psychophysiology Laboratory, Institute of Psychology, Jagiellonian University, Kraków, Poland. Electronic address: tomasz.ligeza@uj.edu.pl.'}, {'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Maciejczyk', 'Affiliation': 'Department of Physiology and Biochemistry, Faculty of Physical Education and Sport, University of Physical Education, Kraków, Poland.'}, {'ForeName': 'Miroslaw', 'Initials': 'M', 'LastName': 'Wyczesany', 'Affiliation': 'Psychophysiology Laboratory, Institute of Psychology, Jagiellonian University, Kraków, Poland.'}, {'ForeName': 'Heiko', 'Initials': 'H', 'LastName': 'Wagner', 'Affiliation': 'Institute for Sports Science, University of Muenster, Muenster, Germany; Otto Creutzfeldt Center for Cognitive and Behavioral Neuroscience, University of Muenster, Muenster, Germany.'}, {'ForeName': 'Kati', 'Initials': 'K', 'LastName': 'Roesmann', 'Affiliation': 'Otto Creutzfeldt Center for Cognitive and Behavioral Neuroscience, University of Muenster, Muenster, Germany; Institute for Clinical Psychology, University of Siegen, Siegen, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Junghofer', 'Affiliation': 'Institute for Biomagnetism and Biosignalanalysis, University of Muenster, Muenster, Germany; Otto Creutzfeldt Center for Cognitive and Behavioral Neuroscience, University of Muenster, Muenster, Germany.'}]",Brain and cognition,['10.1016/j.bandc.2020.105595']
1118,32557211,Breast cancer survivors living with chronic neuropathic pain show improved brain health following mindfulness-based stress reduction: a preliminary diffusion tensor imaging study.,"PURPOSE


The present study explores the benefits of an 8-week mindfulness-based stress reduction (MBSR) program to white matter integrity among breast cancer survivors experiencing chronic neuropathic pain (CNP).
METHODS


Twenty-three women were randomly assigned to either a MBSR treatment group (n = 13) or a waitlist control group (n = 10). Participants were imaged with MRI prior to and post-MBSR training using diffusion tensor imaging.
RESULTS


Compared with controls, the MBSR group showed a significant increase in fractional anisotropy (FA), particularly in the left subcortical regions including the uncinate fasciculus, amygdala, and hippocampus, as well as in the external capsule and in the left sagittal stratum. No decreases to FA were found in any brain regions following MBSR training. The FA values also negatively correlated with the pain severity and pain interference scores from the BRIEF pain questionnaire.
CONCLUSIONS


The present findings demonstrate that MBSR training may enhance the integrity of cerebral white matter that coincides with a reduction in pain perception. Further research with a larger sample size is required.
IMPLICATIONS FOR CANCER SURVIVORS


This study highlights the potential for MBSR, as a non-pharmacological intervention, to provide both brain health improvement and pain perception relief for female breast cancer survivors experiencing CNP.",2020,"Compared with controls, the MBSR group showed a significant increase in fractional anisotropy (FA), particularly in the left subcortical regions including the uncinate fasciculus, amygdala, and hippocampus, as well as in the external capsule and in the left sagittal stratum.","['Breast cancer survivors living with chronic neuropathic pain', 'Twenty-three women', 'FOR CANCER SURVIVORS', 'breast cancer survivors experiencing chronic neuropathic pain (CNP', 'female breast cancer survivors experiencing CNP']","['8-week mindfulness-based stress reduction (MBSR) program', 'MBSR training', 'MBSR treatment', 'mindfulness-based stress reduction', 'waitlist control group']","['pain severity and pain interference scores', 'pain perception', 'fractional anisotropy (FA', 'FA', 'brain health']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C4544057', 'cui_str': 'Chronic neuropathic pain'}, {'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0235653', 'cui_str': 'Malignant neoplasm of female breast'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}, {'cui': 'C0085406', 'cui_str': 'Anisotropy'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",23.0,0.0159926,"Compared with controls, the MBSR group showed a significant increase in fractional anisotropy (FA), particularly in the left subcortical regions including the uncinate fasciculus, amygdala, and hippocampus, as well as in the external capsule and in the left sagittal stratum.","[{'ForeName': 'Ola', 'Initials': 'O', 'LastName': 'Mioduszewski', 'Affiliation': 'Department of Anesthesiology and Pain Medicine,, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Taylor', 'Initials': 'T', 'LastName': 'Hatchard', 'Affiliation': 'Department of Anesthesiology and Pain Medicine,, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Zhuo', 'Initials': 'Z', 'LastName': 'Fang', 'Affiliation': 'Department of Anesthesiology and Pain Medicine,, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Poulin', 'Affiliation': 'Department of Anesthesiology and Pain Medicine,, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Eve-Ling', 'Initials': 'EL', 'LastName': 'Khoo', 'Affiliation': ""Youth Wellness Centre, St. Joseph's Healthcare Hamilton, Hamilton, Canada.""}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Romanow', 'Affiliation': ""Youth Wellness Centre, St. Joseph's Healthcare Hamilton, Hamilton, Canada.""}, {'ForeName': 'Yaad', 'Initials': 'Y', 'LastName': 'Shergill', 'Affiliation': ""Youth Wellness Centre, St. Joseph's Healthcare Hamilton, Hamilton, Canada.""}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Tennant', 'Affiliation': ""Youth Wellness Centre, St. Joseph's Healthcare Hamilton, Hamilton, Canada.""}, {'ForeName': 'Maiko A', 'Initials': 'MA', 'LastName': 'Schneider', 'Affiliation': ""Youth Wellness Centre, St. Joseph's Healthcare Hamilton, Hamilton, Canada.""}, {'ForeName': 'Nikisha', 'Initials': 'N', 'LastName': 'Browne', 'Affiliation': ""Youth Wellness Centre, St. Joseph's Healthcare Hamilton, Hamilton, Canada.""}, {'ForeName': 'Andra M', 'Initials': 'AM', 'LastName': 'Smith', 'Affiliation': 'Department of Anesthesiology and Pain Medicine,, University of Ottawa, Ottawa, Ontario, Canada. asmith@uottawa.ca.'}]",Journal of cancer survivorship : research and practice,['10.1007/s11764-020-00903-w']
1119,32552850,Intense and unpredictable perturbations during gait training improve dynamic balance abilities in chronic hemiparetic individuals: a randomized controlled pilot trial.,"BACKGROUND


Previous studies have assessed the effects of perturbation training on balance after stroke. However, the perturbations were either applied while standing or were small in amplitude during gait, which is not representative of the most common fall conditions. The perturbations were also combined with other challenges such as progressive increases in treadmill speed.
OBJECTIVE


To determine the benefit of treadmill training with intense and unpredictable perturbations compared to treadmill walking-only training for dynamic balance and gait post-stroke.
METHODS


Twenty-one individuals post-stroke with reduced dynamic balance abilities, with or without a history of fall and ability to walk on a treadmill without external support or a walking aid for at least 1 min were allocated to either an unpredictable gait perturbation (Perturb) group or a walking-only (NonPerturb) group through covariate adaptive randomization. Nine training sessions were conducted over 3 weeks. NonPerturb participants only walked on the treadmill but were offered perturbation training after the control intervention. Pre- and post-training evaluations included balance and gait abilities, maximal knee strength, balance confidence and community integration. Six-week phone follow-ups were conducted for balance confidence and community integration. Satisfaction with perturbation training was also assessed.
RESULTS


With no baseline differences between groups (p > 0.075), perturbation training yielded large improvements in most variables in the Perturb (p < 0.05, Effect Size: ES > .46) group (n = 10) and the NonPerturb (p ≤ .089, ES > .45) group (n = 7 post-crossing), except for maximal strength (p > .23) in the NonPerturb group. Walking-only training in the NonPerturb group (n = 8, pre-crossing) mostly had no effect (p > .292, ES < .26), except on balance confidence (p = .063, ES = .46). The effects of the gait training were still present on balance confidence and community integration at follow-up. Satisfaction with the training program was high.
CONCLUSION


Intense and unpredictable gait perturbations have the potential to be an efficient component of training to improve balance abilities and community integration in individuals with chronic stroke. Retrospective registration: ClinicalTrials.gov. March 18th, 2020. Identifier: NCT04314830.",2020,", perturbation training yielded large improvements in most variables in the Perturb (p < 0.05, Effect Size: ES > .46) group (n = 10) and the NonPerturb (p ≤ .089, ES > .45) group (n = 7 post-crossing), except for maximal strength (p > .23) in the NonPerturb group.","['Twenty-one individuals post-stroke with reduced dynamic balance abilities, with or without a history of fall and ability to walk on a treadmill without external support or a walking aid for at least 1\u2009min', 'chronic hemiparetic individuals', 'individuals with chronic stroke']","['gait training', 'treadmill training with intense and unpredictable perturbations compared to treadmill walking-only training', 'unpredictable gait perturbation (Perturb) group or a walking-only (NonPerturb) group through covariate adaptive randomization', 'perturbation training']","['balance and gait abilities, maximal knee strength, balance confidence and community integration', 'dynamic balance abilities', 'balance confidence', 'maximal strength', 'progressive increases in treadmill speed', 'balance confidence and community integration']","[{'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0560184', 'cui_str': 'Ability to balance'}, {'cui': 'C1561668', 'cui_str': 'History of fall'}, {'cui': 'C0559964', 'cui_str': 'Ability to walk'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}]","[{'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C3494302', 'cui_str': 'Community Integration'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0560184', 'cui_str': 'Ability to balance'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}]",,0.0445433,", perturbation training yielded large improvements in most variables in the Perturb (p < 0.05, Effect Size: ES > .46) group (n = 10) and the NonPerturb (p ≤ .089, ES > .45) group (n = 7 post-crossing), except for maximal strength (p > .23) in the NonPerturb group.","[{'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Esmaeili', 'Affiliation': 'School of Rehabilitation, Université de Montréal, P.O. Box 6128, Station Centre-Ville, Montreal, Quebec, H3C 3J7, Canada.'}, {'ForeName': 'Andréanne', 'Initials': 'A', 'LastName': 'Juneau', 'Affiliation': ""Centre for Interdisciplinary Research in Rehabilitation-Institut Universitaire sur la Réadaptation en Déficience Physique de Montréal, in CIUSSS du Centre-Sud-de-l'ile-de-Montréal, Montreal, Canada.""}, {'ForeName': 'Joseph-Omer', 'Initials': 'JO', 'LastName': 'Dyer', 'Affiliation': 'School of Rehabilitation, Université de Montréal, P.O. Box 6128, Station Centre-Ville, Montreal, Quebec, H3C 3J7, Canada.'}, {'ForeName': 'Anouk', 'Initials': 'A', 'LastName': 'Lamontagne', 'Affiliation': ""Centre for Interdisciplinary Research in Rehabilitation-Institut Universitaire sur la Réadaptation en Déficience Physique de Montréal, in CIUSSS du Centre-Sud-de-l'ile-de-Montréal, Montreal, Canada.""}, {'ForeName': 'Dahlia', 'Initials': 'D', 'LastName': 'Kairy', 'Affiliation': 'School of Rehabilitation, Université de Montréal, P.O. Box 6128, Station Centre-Ville, Montreal, Quebec, H3C 3J7, Canada.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Bouyer', 'Affiliation': 'Department of Rehabilitation, Faculty of Medicine, Université Laval and Center for Interdisciplinary Research in Rehabilitation and Social Integration, CIUSSS-CN, Quebec City, Canada.'}, {'ForeName': 'Cyril', 'Initials': 'C', 'LastName': 'Duclos', 'Affiliation': 'School of Rehabilitation, Université de Montréal, P.O. Box 6128, Station Centre-Ville, Montreal, Quebec, H3C 3J7, Canada. cyril.duclos@umontreal.ca.'}]",Journal of neuroengineering and rehabilitation,['10.1186/s12984-020-00707-0']
1120,32556001,The contribution of mindfulness to outpatient substance use disorder treatment in Brazil: a preliminary study.,"OBJECTIVE


To explore the contribution of a mindfulness-based intervention as an adjuvant to outpatient substance use disorder treatment. Outcomes included substance use behavior, depression and anxiety symptoms, and anger expression.
METHODS


This preliminary study for a pragmatic randomized controlled trial with stratified random allocation included three months of follow-up. In two outpatient clinics linked to public universities, a mindfulness-based intervention plus treatment as usual (experimental group n=22) was compared to treatment as usual (control group n=20). The study included data from self-report measurements and the patients' records, which were evaluated according to intention-to-treat analysis through generalized estimating equations and generalized method of moments estimation.
RESULTS


The experimental group had lower symptoms of depression (b=-6.82; 95%CI -12.45 to -1.18) and anxiety (b=-0.25; 95%CI -0.42 to -0.09), and anger expression (b=-9.76; 95%CI -18.98 to -0.54) three months after the intervention. We detected no effect on substance use behavior.
CONCLUSION


The mindfulness-based intervention yielded promising results as an adjuvant to outpatient substance use disorder treatment, since it reduced levels of highly prevalent symptoms in this population. However, further studies with longer follow-up periods and larger samples are required.",2020,"The experimental group had lower symptoms of depression (b=-6.82; 95%CI -12.45 to -1.18) and anxiety (b=-0.25; 95%CI -0.42 to -0.09), and anger expression (b=-9.76; 95%CI -18.98 to -0.54) three months after the intervention.",['Brazil'],['mindfulness-based intervention'],"['anger expression', 'substance use behavior, depression and anxiety symptoms, and anger expression', 'lower symptoms of depression', 'anxiety']","[{'cui': 'C0006137', 'cui_str': 'Brazil'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.0930051,"The experimental group had lower symptoms of depression (b=-6.82; 95%CI -12.45 to -1.18) and anxiety (b=-0.25; 95%CI -0.42 to -0.09), and anger expression (b=-9.76; 95%CI -18.98 to -0.54) three months after the intervention.","[{'ForeName': 'Mayra P', 'Initials': 'MP', 'LastName': 'Machado', 'Affiliation': 'Departamento de Psicobiologia, Universidade Federal de São Paulo (UNIFESP), São Paulo, SP, Brazil.'}, {'ForeName': 'Thiago M', 'Initials': 'TM', 'LastName': 'Fidalgo', 'Affiliation': 'Departamento de Psiquiatria, UNIFESP, São Paulo, SP, Brazil.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Brasiliano', 'Affiliation': 'Programa da Mulher Dependente Química (PROMUD), Departamento e Instituto de Psiquiatria (IPq), Hospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo (USP), São Paulo, SP, Brazil.'}, {'ForeName': 'Patrícia B', 'Initials': 'PB', 'LastName': 'Hochgraf', 'Affiliation': 'Programa da Mulher Dependente Química (PROMUD), Departamento e Instituto de Psiquiatria (IPq), Hospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo (USP), São Paulo, SP, Brazil.'}, {'ForeName': 'Ana R', 'Initials': 'AR', 'LastName': 'Noto', 'Affiliation': 'Departamento de Psicobiologia, Universidade Federal de São Paulo (UNIFESP), São Paulo, SP, Brazil.'}]","Revista brasileira de psiquiatria (Sao Paulo, Brazil : 1999)",['10.1590/1516-4446-2019-0725']
1121,32561506,"Quality of life, body image, and mobility in lower-limb amputees using high-tech prostheses: A pragmatic trial.","BACKGROUND


High-tech prostheses are supposed to achieve better functional recovery over mechanical-controlled prostheses in lower-limb amputees. However, quantitative data are insufficient.
OBJECTIVE


We aimed to evaluate changes in quality of life, life satisfaction, perception of body image, and functional performance of lower-limb amputees when using a mechanical-controlled prosthesis versus a microprocessor-controlled knee (MPK) or transtibial vacuum-assisted suspension system (VASS) prosthesis.
METHODS


In this pragmatic study, 57 lower-limb amputees were assessed with the Satisfaction with the Prosthesis Questionnaire (SATPRO), revised Amputee Body Image Scale (ABIS-R), Trinity Amputation and Prosthesis Experience Scales (TAPES), Medical Outcomes Study Short Form-36 (SF-36) and 6-min walk test (6MWT). All assessments were performed under 2 conditions (i.e., using a mechanical-controlled prosthesis vs. an MPK/VASS prosthesis.
RESULTS


Amputees who used an MPK/VASS prosthesis showed significant increases in all SF-36 subscale scores and all subscale scores of TAPES except adjustment to limitation (P=0.156). The amputees showed clinically relevant improvements in 6MWT (P<0.001) and in SATPRO and ABIS-R scores (P<0.001).
CONCLUSION


Lower-limb amputees using an MPK/VASS prosthesis had better life satisfaction, quality of life and functional performance than those using a mechanical-controlled prosthesis.",2020,"RESULTS


Amputees who used an MPK/VASS prosthesis showed significant increases in all SF-36 subscale scores and all subscale scores of TAPES except adjustment to limitation (p=0.156).","['57 lower-limb amputees', 'lower-limb amputees using high-tech prostheses']","['MPK/VASS prosthesis', 'mechanical-controlled prosthesis versus a microprocessor-controlled knee (MPK) or transtibial vacuum-assisted suspension system (VASS) prosthesis']","['quality of life, life satisfaction, perception of body image, and functional performance', '6MWT (p<0.001) and in SATPRO and ABIS-R scores', 'Quality of life, body image and mobility', 'life satisfaction, quality of life and functional performance', 'Satisfaction with the Prosthesis Questionnaire (SATPRO), revised Amputee Body Image Scale (ABIS-R), Trinity Amputation and Prosthesis Experience Scales', 'TAPES), Medical Outcomes Study Short Form-36 (SF-36) and 6-min walk test (6MWT', 'SF-36 subscale scores']","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0002695', 'cui_str': 'Amputee'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}]","[{'cui': 'C0026012', 'cui_str': 'Microprocessors'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0042221', 'cui_str': 'Vacuum'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0005891', 'cui_str': 'Body image'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0002695', 'cui_str': 'Amputee'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0343138', 'cui_str': 'Strapping procedure'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0543472', 'cui_str': 'Outcome Studies'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0459443', 'cui_str': 'Subscale score'}]",57.0,0.0833121,"RESULTS


Amputees who used an MPK/VASS prosthesis showed significant increases in all SF-36 subscale scores and all subscale scores of TAPES except adjustment to limitation (p=0.156).","[{'ForeName': 'Burcu', 'Initials': 'B', 'LastName': 'Burçak', 'Affiliation': 'Ministry of Health, Ankara Physical Medicine and Rehabilitation Training and Research Hospital, Department of Physical Medicine and Rehabilitation, Ankara, Turkey.'}, {'ForeName': 'Bilge', 'Initials': 'B', 'LastName': 'Kesikburun', 'Affiliation': 'Ministry of Health, Ankara Physical Medicine and Rehabilitation Training and Research Hospital, Department of Physical Medicine and Rehabilitation, Ankara, Turkey. Electronic address: drbilgekb@gmail.com.'}, {'ForeName': 'Belma Füsun', 'Initials': 'BF', 'LastName': 'Köseoğlu', 'Affiliation': 'Ministry of Health, Ankara Physical Medicine and Rehabilitation Training and Research Hospital, Department of Physical Medicine and Rehabilitation, Ankara, Turkey.'}, {'ForeName': 'Öznur', 'Initials': 'Ö', 'LastName': 'Öken', 'Affiliation': 'Ministry of Health, Ankara Physical Medicine and Rehabilitation Training and Research Hospital, Department of Physical Medicine and Rehabilitation, Ankara, Turkey.'}, {'ForeName': 'Asuman', 'Initials': 'A', 'LastName': 'Doğan', 'Affiliation': 'Ministry of Health, Ankara Physical Medicine and Rehabilitation Training and Research Hospital, Department of Physical Medicine and Rehabilitation, Ankara, Turkey.'}]",Annals of physical and rehabilitation medicine,['10.1016/j.rehab.2020.03.016']
1122,32567234,"The impact of negative-pressure wound therapy with instillation on wounds requiring operative debridement: Pilot randomised, controlled trial.","Presence of bacteria in wounds can delay healing. Addition of a regularly instilled topical solution over the wound during negative-pressure wound therapy (NPWT) may reduce bioburden levels compared with standard NPWT alone. We performed a prospective, randomised, multi-centre, post-market trial to compare effects of NPWT with instillation and dwell of polyhexamethylene biguanide solution vs NPWT without instillation therapy in wounds requiring operative debridement. Results showed a significantly greater mean decrease in total bacterial counts from time of initial surgical debridement to first dressing change in NPWT plus instillation (n = 69) subjects compared with standard NPWT (n = 63) subjects (-0.18 vs 0.6 log 10  CFU/g, respectively). There was no significant difference between the groups in the primary endpoint of required inpatient operating room debridements after initial debridement. Time to readiness for wound closure/coverage, proportion of wounds closed, and incidence of wound complications were similar. NPWT subjects had 3.1 times the risk of re-hospitalisation compared with NPWT plus instillation subjects. This study provides a basis for exploring research options to understand the impact of NPWT with instillation on wound healing.",2020,NPWT subjects had 3.1 times the risk of re-hospitalisation compared with NPWT plus instillation subjects.,['wounds requiring operative debridement'],"['negative-pressure wound therapy with instillation', 'NPWT with instillation and dwell of polyhexamethylene biguanide solution vs NPWT without instillation therapy', 'standard NPWT', 'negative-pressure wound therapy (NPWT']","['total bacterial counts', 'bioburden levels', 'Time to readiness for wound closure/coverage, proportion of wounds closed, and incidence of wound complications', 'risk of re-hospitalisation']","[{'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}]","[{'cui': 'C1956078', 'cui_str': 'Topical Negative-Pressure Therapy'}, {'cui': 'C0184959', 'cui_str': 'Instillation'}, {'cui': 'C0376892', 'cui_str': 'polihexanide'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0004618', 'cui_str': 'Bacterial count'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0450015', 'cui_str': 'Method of wound closure'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",69.0,0.0491176,NPWT subjects had 3.1 times the risk of re-hospitalisation compared with NPWT plus instillation subjects.,"[{'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Kim', 'Affiliation': 'Department of Plastic Surgery, University of Texas Southwestern Medical Center, Dallas, Texas, USA.'}, {'ForeName': 'Lawrence A', 'Initials': 'LA', 'LastName': 'Lavery', 'Affiliation': 'Department of Plastic Surgery, University of Texas Southwestern Medical Center, Dallas, Texas, USA.'}, {'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'Galiano', 'Affiliation': 'Northwestern Memorial Hospital, Chicago, Illinois, USA.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Salgado', 'Affiliation': 'University of Miami Health System, Miami, Florida, USA.'}, {'ForeName': 'Dennis P', 'Initials': 'DP', 'LastName': 'Orgill', 'Affiliation': ""Division of Plastic Surgery, Brigham & Women's Hospital Wound Care Center, Boston, Massachusetts, USA.""}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Kovach', 'Affiliation': 'Penn Plastic Surgery University City, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Brent H', 'Initials': 'BH', 'LastName': 'Bernstein', 'Affiliation': ""St. Luke's University Health Network, Bethlehem, Pennsylvania, USA.""}, {'ForeName': 'Christopher E', 'Initials': 'CE', 'LastName': 'Attinger', 'Affiliation': 'Department of Plastic Surgery, MedStar Georgetown University Hospital, Washington, District of Columbia, USA.'}]",International wound journal,['10.1111/iwj.13424']
1123,32564482,Randomised trial of telephone counselling to improve participants' adherence to prescribed drugs in a vascular screening trial.,"A total of 1446 participants, 65- to 74-year-old men diagnosed with abdominal aortic aneurysm (AAA), peripheral arterial disease (PAD) or high blood pressure (HB) in the Viborg Vascular (VIVA) screening trial, were consecutively included and randomised to a telephone counselling (TC) or no TC 3 months after being screened positive. Data from VIVA were linked to data from Danish registers from 2007 to 2016. The primary outcome was a composite outcome of proportion of days covered by statin, antithrombotic drugs and antihypertensive agents and for each specific drug class at 6-month follow-up. The same outcomes were assessed at 12 and 60 months and considered secondary outcomes. Outcome measures are reported as risk differences (RD). There were no differences between the groups in relation to the composite of all three drug classes over 6 months of follow-up, RD = 4.1 (95% CI: -1.0; 9.1). A significant increase in redeemed statin prescriptions was observed in the intervention group at 6 months, RD = 9.8% (CI 95%: 0.5; 19.0). There was no intervention effect observed after 12 and 60 months. TC 3 months after screening improved adherence to statin at 6-month follow-up, but had no effect on the composite treatment, statins, antithrombotic or antihypertensive treatment over 60 months of follow-up.",2020,"There were no differences between the groups in relation to the composite of all three drug classes over 6 months of follow-up, RD = 4.1 (95%CI: -1.0; 9.1).","[""participants' adherence to prescribed drugs in a cardiovascular screening trial"", '1,446 participants; 65-74-year-old men diagnosed with abdominal aortic aneurysm (AAA), peripheral arterial disease (PAD) or high blood pressure (HB) in the Viborg Vascular (VIVA) screening trial']","['telephone counselling', 'telephone counselling (TC) or no TC']","['redeemed statin prescriptions', 'risk differences (RD', 'composite outcome of proportion of days covered (PDC) by statin, antithrombotic drugs and antihypertensive agents and for each specific drug class']","[{'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0162871', 'cui_str': 'Abdominal aortic aneurysm'}, {'cui': 'C0085096', 'cui_str': 'Peripheral vascular disease'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0456387', 'cui_str': 'Class'}]",1446.0,0.163178,"There were no differences between the groups in relation to the composite of all three drug classes over 6 months of follow-up, RD = 4.1 (95%CI: -1.0; 9.1).","[{'ForeName': 'Ina', 'Initials': 'I', 'LastName': 'Qvist', 'Affiliation': 'Department of Cardiology, Diagnostic Centre, Regional Hospital Central Jutland, Silkeborg, Denmark.'}, {'ForeName': 'Jes S', 'Initials': 'JS', 'LastName': 'Lindholt', 'Affiliation': 'Department of Vascular Surgery, Regional Hospital Central Jutland, Viborg, Denmark.'}, {'ForeName': 'Rikke', 'Initials': 'R', 'LastName': 'Søgaard', 'Affiliation': 'Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Vibeke', 'Initials': 'V', 'LastName': 'Lorentzen', 'Affiliation': 'The Centre for Nursing Research, Viborg, Denmark.'}, {'ForeName': 'Jesper', 'Initials': 'J', 'LastName': 'Hallas', 'Affiliation': 'Department of Clinical Chemistry & Pharmacology, Odense University Hospital, Odense C, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Frost', 'Affiliation': 'Department of Cardiology, Diagnostic Centre, Regional Hospital Central Jutland, Silkeborg, Denmark.'}]",Basic & clinical pharmacology & toxicology,['10.1111/bcpt.13459']
1124,32572614,Piecewise regression equations for estimating stature: an anthropometric study in Spanish females.,"In forensic anthropology, generic equations are generally preferred for estimation of stature. However, recent studies have demonstrated that regression equations specific to stature groups yield more accurate predictions. Almost all previous studies have been conducted on male subjects, and it is not currently known how well such equations work for females. Therefore, this study aims to test whether regression equations specific to stature groups work for females as well. To this end, a cross-sectional study was conducted to estimate stature on a sample of 351 Spanish adult females. The participants were randomized into a calibration group (n = 185) and a validation group (n = 166). Equations for stature estimation based on tibial length were developed in the calibration group, which was categorized according to stature (short, medium, and tall) using the 15th and 85th percentiles as cut-off points. The standard errors of the estimations (SEEs) for the group-specific regression equations (SEE = 2.35-2.66 cm) were lower than for the general formula derived for all participants of the calibration group (SEE = 3.46 cm). The specific equations resulted in smaller differences between estimated and recorded statures than the generic equation when we tested the equations with the validation group. Additionally, the SEE values of the stature-specific equations are lower compared to generic equations applied to other human populations. In conclusion, the group-specific equations from tibial length have high accuracy compared with previously derived equations for Spanish females and other populations. This procedure for estimating stature thereby improves the tools available to forensic scientists.",2020,The specific equations resulted in smaller differences between estimated and recorded statures than the generic equation when we tested the equations with the validation group.,"['351 Spanish adult females', 'male subjects', 'Spanish females']",[],['tibial length'],"[{'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}]",[],"[{'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C1444754', 'cui_str': 'Length'}]",351.0,0.0279549,The specific equations resulted in smaller differences between estimated and recorded statures than the generic equation when we tested the equations with the validation group.,"[{'ForeName': 'Gonzalo', 'Initials': 'G', 'LastName': 'Saco-Ledo', 'Affiliation': 'Catalan School of Kinanthropometry, National Institute of Physical Education, University of Barcelona, Barcelona, Spain. gonzalo.saco@cenieh.es.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Porta', 'Affiliation': 'Catalan School of Kinanthropometry, National Institute of Physical Education, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Tesla A', 'Initials': 'TA', 'LastName': 'Monson', 'Affiliation': 'Department of Anthropology, Western Washington University, Bellingham, WA, USA.'}, {'ForeName': 'Marianne F', 'Initials': 'MF', 'LastName': 'Brasil', 'Affiliation': 'Human Evolution Research Center, University of California Berkeley, Berkeley, CA, USA.'}, {'ForeName': 'Derya', 'Initials': 'D', 'LastName': 'Atamtürk', 'Affiliation': 'Department of Anthropology, Faculty of Letters, Istanbul University, Istanbul, Turkey.'}, {'ForeName': 'Izzet', 'Initials': 'I', 'LastName': 'Duyar', 'Affiliation': 'Department of Anthropology, Faculty of Letters, Istanbul University, Istanbul, Turkey.'}]",International journal of legal medicine,['10.1007/s00414-020-02350-9']
1125,32569090,"Intrathecal delivery of hydromorphone vs morphine for refractory cancer pain: a multicenter, randomized, single-blind, controlled noninferiority trial.","Hydromorphone is an alternative to morphine for intrathecal drug delivery system to treat refractory cancer pain; however, there is not enough clinical evidence to prove it. In our study, 233 patients from 12 different pain management centers across China were enrolled, 121 and 112 in the intrathecal hydromorphone (ITHM) and intrathecal morphine (ITMO) groups, respectively. The primary outcome was the clinical success rate, which was defined as ratio of patients achieving ≥50% pain relief. The noninferiority margin was defined as -0.15. Other outcomes included daily visual analogue scale score, breakthrough pain (BTP) incidence, intrathecal dose change, and patient-controlled analgesia bolus count change, GAD-7/PHQ-9. Clinical success was achieved in 85 and 79 of the 121 ITHM patients (70.2%) and 112 ITMO patients (70.5%), respectively. Compared to the corresponding baseline findings, significantly decreased visual analogue scale scores and BTP incidence were noted in both groups. The dose change rate decreased and increased with time in the ITHM and ITMO groups, respectively (ITHM -3.33% vs ITMO 35.4%, P < 0.01, t test) from the third week. The patient-controlled analgesia bolus change rate was lower in the ITHM group than in the ITMO group (ITHM -19.88% vs ITMO 7.79%, P < 0.01, t test) from first week. Our result shows that ITHM is noninferior to ITMO on pain relief to treat refractory cancer pain, however, at different doses and that the doses of morphine tended to increase, whereas those of hydromorphone decreased over time. Hydromorphone offers advantage over morphine in controlling BTP.",2020,"The PCA bolus change rate was lower in the ITHM group than in the ITMO group (ITHM - 19.88% vs ITMO 7.79%, P < .01, t-test) from first week.","['233 patients from 12 different pain management centers across China were enrolled, 121 and 112 in the', 'refractory cancer pain']","['hydromorphone', 'ITMO', 'ITHM', 'Hydromorphone', 'intrathecal morphine', 'intrathecal hydromorphone (ITHM) and intrathecal morphine (ITMO', 'hydromorphone vs morphine', 'intrathecal hydromorphone', 'morphine']","['PCA bolus change rate', 'pain relief', 'Clinical success', 'clinical success rate, which was defined as ratio of patients achieving ≥ 50% pain relief', 'VAS scores and BTP incidence', 'daily visual analog scale (VAS) score, breakthrough pain (BTP) incidence, intrathecal dose change and PCA bolus count change, GAD-7/PHQ-9', 'change rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0677936', 'cui_str': 'Refractory cancer'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0012306', 'cui_str': 'Hydromorphone'}, {'cui': 'C0677897', 'cui_str': 'Intrathecal route'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]","[{'cui': 'C0030131', 'cui_str': 'p-Chloramphetamine'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C1135120', 'cui_str': 'Breakthrough pain'}, {'cui': 'C0677897', 'cui_str': 'Intrathecal route'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0270549', 'cui_str': 'Generalized anxiety disorder'}]",233.0,0.0995406,"The PCA bolus change rate was lower in the ITHM group than in the ITMO group (ITHM - 19.88% vs ITMO 7.79%, P < .01, t-test) from first week.","[{'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Ma', 'Affiliation': 'Department of Pain Medicine, Xinhua Hospital affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Jin', 'Affiliation': 'Pain Management Center, Nanjing General Hospital, Nanjing, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Pain Medicine, The Affiliated Hospital of Guizhou Medical University, Guiyang, China.'}, {'ForeName': 'Zhi-Ying', 'Initials': 'ZY', 'LastName': 'Feng', 'Affiliation': 'Department of Pain Medicine, the First Affiliated Hospital, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Song', 'Affiliation': 'Department of Pain Medicine, the First Affiliated Hospital, China Medical University, Heping, Shenyang, China.'}, {'ForeName': 'Xiao-Qiu', 'Initials': 'XQ', 'LastName': 'Yang', 'Affiliation': 'Department of Pain Medicine, the First Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Fu-Qiang', 'Initials': 'FQ', 'LastName': 'Chen', 'Affiliation': 'Department of Pain Medicine, Qingdao Municipal Hospital, Qingdao, China.'}, {'ForeName': 'Bao-Lin', 'Initials': 'BL', 'LastName': 'Duan', 'Affiliation': ""Department of Pain Medicine, Qinghai Provincial People's Hospital, Xi'ning, China.""}, {'ForeName': 'You-Qing', 'Initials': 'YQ', 'LastName': 'Huang', 'Affiliation': 'Department of Pain Medicine, The 2nd Affiliated Hospital of Kunming Medical University, Kunming, China.'}, {'ForeName': 'Guang-Lun', 'Initials': 'GL', 'LastName': 'Xie', 'Affiliation': 'Department of Pain Medicine, Henan Cancer Hospital, Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Hong-Guang', 'Initials': 'HG', 'LastName': 'Bao', 'Affiliation': 'Department of Pain Medicine, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Department of Pharmacometrics, Center for Drug Clinical Research, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Jiang-Tao', 'Initials': 'JT', 'LastName': 'Xu', 'Affiliation': 'Department of Pain Medicine, Xinhua Hospital affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': ""Department of Pain Medicine, Xijing Hospital, The Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Yan-Qing', 'Initials': 'YQ', 'LastName': 'Liu', 'Affiliation': 'Department of Pain Medicine, Beijing Tiantan Hospital, Capital Medical University, Tiantan, Dongcheng, Beijing, China.'}]",Pain,['10.1097/j.pain.0000000000001957']
1126,32574761,HAWK and HARRIER: Ninety-Six-Week Outcomes from the Phase 3 Trials of Brolucizumab for Neovascular Age-Related Macular Degeneration.,"PURPOSE


To report the 96-week outcomes from HAWK and HARRIER.
DESIGN


Phase 3, prospective, randomized, double-masked, multicenter studies comparing efficacy and safety of brolucizumab 3 mg (HAWK only) and 6 mg with aflibercept 2 mg in eyes with neovascular age-related macular degeneration (nAMD).
PARTICIPANTS


Treatment-naïve eyes with nAMD were randomized 1:1:1 to brolucizumab 3 mg (n = 358), brolucizumab 6 mg (n = 360), aflibercept 2 mg (n = 360; HAWK) or 1:1 to brolucizumab 6 mg (n = 370), aflibercept 2 mg (n = 369; HARRIER).
METHODS


After 3 monthly loading doses, brolucizumab patients received every (q)-12-week (w) dosing, possibly adjusting to q8w dosing if disease activity was present at predefined disease activity assessment (DAA) visits. Aflibercept was dosed in a fixed q8w regimen. Visual and anatomic parameters were assessed throughout. Primary end point was at week 48 (48w), confirmed at 96w.
MAIN OUTCOME MEASURES


Mean best-corrected visual acuity (BCVA) change from baseline, proportion of patients on an q12w regimen, retinal thickness, retinal fluid changes, and safety, all to 96w.
RESULTS


Mean change (least squares [LS] mean ± standard error) in BCVA from baseline to 96w in HAWK was 5.6±0.79 Early Treatment Diabetic Retinopathy Study (ETDRS) letters for brolucizumab 3 mg, 5.90±0.78 letters for brolucizumab 6 mg, and 5.3±0.78 letters for aflibercept and in HARRIER was 6.1±0.73 letters for brolucizumab 6 mg and 6.6 ± 0.73 letters for aflibercept. Greater central subfield thickness reductions were observed with brolucizumab 6 mg versus aflibercept in HAWK (LS mean, -174.8 μm vs. -148.7 μm; 95% confidence interval for treatment difference, -46.2 to -5.9 μm; P = 0.0115) and HARRIER (LS mean, -197.7 μm vs. -155.1 μm; 95% confidence interval for treatment difference, -62.0 to -23.3 μm; P < 0.0001). The proportions of eyes with intraretinal fluid and/or subretinal fluid (IRF/SRF) at 96w in HAWK were 31% (P = 0.0688) and 24% (P = 0.0002) for brolucizumab 3 mg and 6 mg and 37% for aflibercept, whereas in HARRIER, they were 24% for brolucizumab 6 mg (P < 0.0001) and 39% for aflibercept. At 92w (last DAA), a 45.4% and 38.6% probability was observed for brolucizumab 6 mg patients of maintaining an q12w treatment regimen in HAWK and HARRIER, respectively. Brolucizumab exhibited an overall well-tolerated safety profile.
CONCLUSIONS


Visual outcomes from 48w to 96w confirm the efficacy achieved at 48w. Brolucizumab demonstrated greater fluid resolution compared with aflibercept. The q12w potential for brolucizumab observed at 48w was maintained to 96w.",2020,"Greater central subfield thickness (CST) reductions were observed with brolucizumab 6mg vs aflibercept in HAWK (LS mean; -174.8 vs -148.7 μm; 95% CI for treatment difference -46.2, -5.9; p=0.0115) and HARRIER (LS mean; -197.7 vs -155.1 μm; 95% CI for treatment difference, -62.0, -23.3; p<0.0001).","['neovascular age-related macular degeneration', 'eyes with neovascular AMD (nAMD) PARTICIPANTS: Treatment naive eyes with nAMD']","['brolucizumab 3mg', 'aflibercept', 'Aflibercept', 'brolucizumab', 'brolucizumab 6mg (n=370) or aflibercept 2mg (n=369) [HARRIER', 'HAWK and HARRIER', 'Brolucizumab', 'brolucizumab 6mg (n=360) or aflibercept 2mg (n=360) [HAWK']","['Visual and anatomical parameters', 'proportion of eyes with intraretinal fluid and/or subretinal fluid (IRF/SRF', 'Mean change (LS mean ±SE) in BCVA (ETDRS letters', 'efficacy and safety', 'overall well-tolerated safety profile', 'Greater central subfield thickness (CST) reductions', 'Mean best corrected visual acuity (BCVA) change from baseline, proportion of patients on q12w, retinal thickness, retinal fluid changes, and safety', 'fluid resolution']","[{'cui': 'C0271084', 'cui_str': 'Exudative age-related macular degeneration'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0017921', 'cui_str': 'Generalized glycogenosis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C4550124', 'cui_str': 'brolucizumab'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C0324380', 'cui_str': 'Harrier dog'}, {'cui': 'C0325553', 'cui_str': 'Hawk'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C4531067', 'cui_str': 'Intraretinal fluid'}, {'cui': 'C1720732', 'cui_str': 'Subretinal fluid'}, {'cui': 'C0063613', 'cui_str': 'insulin resistance factor (uremia)'}, {'cui': 'C0037668', 'cui_str': 'Somatotropin releasing factor'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}]",,0.0754469,"Greater central subfield thickness (CST) reductions were observed with brolucizumab 6mg vs aflibercept in HAWK (LS mean; -174.8 vs -148.7 μm; 95% CI for treatment difference -46.2, -5.9; p=0.0115) and HARRIER (LS mean; -197.7 vs -155.1 μm; 95% CI for treatment difference, -62.0, -23.3; p<0.0001).","[{'ForeName': 'Pravin U', 'Initials': 'PU', 'LastName': 'Dugel', 'Affiliation': 'Retinal Consultants of Arizona, Phoenix, Arizona. Electronic address: pdugel@gmail.com.'}, {'ForeName': 'Rishi P', 'Initials': 'RP', 'LastName': 'Singh', 'Affiliation': 'Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Koh', 'Affiliation': 'Eye & Retina Surgeons, Singapore, Republic of Singapore.'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Ogura', 'Affiliation': 'Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.'}, {'ForeName': 'Georges', 'Initials': 'G', 'LastName': 'Weissgerber', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Kinfemichael', 'Initials': 'K', 'LastName': 'Gedif', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Glenn J', 'Initials': 'GJ', 'LastName': 'Jaffe', 'Affiliation': 'Duke Eye Center, Durham, North Carolina.'}, {'ForeName': 'Ramin', 'Initials': 'R', 'LastName': 'Tadayoni', 'Affiliation': 'Lariboisiere & Saint Louis Hospitals, Universite de Paris, Paris, France.'}, {'ForeName': 'Ursula', 'Initials': 'U', 'LastName': 'Schmidt-Erfurth', 'Affiliation': 'Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Frank G', 'Initials': 'FG', 'LastName': 'Holz', 'Affiliation': 'University of Bonn, Bonn, Germany.'}]",Ophthalmology,['10.1016/j.ophtha.2020.06.028']
1127,32574773,Macular and Peripapillary Optical Coherence Tomography Angiography Metrics Predict Progression in Diabetic Retinopathy: A Sub-analysis of TIME-2b Study Data.,"PURPOSE


To identify optical coherence tomography angiography (OCTA)-derived vessel metrics of the macula and optic nerve head (ONH) that predict diabetic retinopathy (DR) disease progression.
DESIGN


Secondary analysis of clinical trial data.
METHODS


This was a sub-analysis of prospectively collected data from 73 subjects that participated in the TIME-2b study (Aerpio Pharmaceuticals), a multicenter clinical trial for patients with moderate-to-severe DR treated with AKB-9778 and followed over a 12-month period. Eligible subjects were tested every 3 months with color fundus photography, spectral-domain OCT, and slit-lamp biomicroscopy. OCTA of the macula and ONH was obtained for a subset of patients enrolled at participating sites. En face, full-depth retinal projections centered at the macula were analyzed for multiple metrics including foveal avascular zone (FAZ) area and perimeter, nonperfusion area, vessel density (VD), and presence of intraretinal microvascular abnormalities (IRMA). VD of the radial peripapillary capillaries was evaluated in 4 quadrants surrounding the optic disc for ONH images. Progression was defined as a ≥2-step increase in DR severity scale score or development of diabetic macular edema.
RESULTS


Over a follow-up period of 12 months, 15 of 73 (20.5%) subjects progressed. At pretreatment baseline, larger FAZ area, presence of IRMA, and reduced peripapillary VD in the superior temporal and inferior temporal regions were significantly associated with increased odds of progression.
CONCLUSIONS


FAZ area and temporal peripapillary VD are predictors of DR progression. OCTA metrics may improve progression risk assessment in DR when compared to established risk factors alone.",2020,"At pre-treatment baseline, larger FAZ area, presence of IRMA, and reduced peripapillary VD in the superior temporal and inferior temporal regions were significantly associated with increased odds of progression.
","['Diabetic Retinopathy', '73 subjects that participated in the TIME-2b Study (Aerpio Pharmaceuticals), a multi-center clinical trial for patients with moderate to severe DR treated with AKB-9778 and followed over a 12-month period']","['color fundus photography, spectral domain OCT and slit-lamp biomicroscopy', 'optical coherence tomography angiography (OCTA']","['larger FAZ area, presence of IRMA, and reduced peripapillary VD', 'DR severity scale score or development of diabetic macular edema', 'foveal avascular zone (FAZ) area and perimeter, non-perfusion area, vessel density (VD) and presence of intraretinal microvascular abnormalities (IRMA']","[{'cui': 'C0011884', 'cui_str': 'Retinopathy due to diabetes mellitus'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0013058', 'cui_str': 'Pharmaceutical dose form'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C4043862', 'cui_str': 'AKB-9778'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0200189', 'cui_str': 'Ocular fundus photography'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C0419360', 'cui_str': 'Ocular slit lamp examination'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}]","[{'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C1275950', 'cui_str': 'Foveal avascular zone'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C3714733', 'cui_str': 'Intraretinal microvascular abnormality'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0442163', 'cui_str': 'Peripapillary'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0011884', 'cui_str': 'Retinopathy due to diabetes mellitus'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0730285', 'cui_str': 'Macular edema due to diabetes mellitus'}, {'cui': 'C0182215', 'cui_str': 'Perimeter'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}]",73.0,0.0248145,"At pre-treatment baseline, larger FAZ area, presence of IRMA, and reduced peripapillary VD in the superior temporal and inferior temporal regions were significantly associated with increased odds of progression.
","[{'ForeName': 'Eugenia', 'Initials': 'E', 'LastName': 'Custo Greig', 'Affiliation': 'New England Eye Center, Boston, Massachusetts, USA; Yale School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Mitchell', 'Initials': 'M', 'LastName': 'Brigell', 'Affiliation': 'Aerpio Pharmaceuticals, Cincinnati, Ohio, USA.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Cao', 'Affiliation': 'New England Eye Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Emily S', 'Initials': 'ES', 'LastName': 'Levine', 'Affiliation': 'New England Eye Center, Boston, Massachusetts, USA; Tufts University School of Medicine, Boston, Massachusetts, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Peters', 'Affiliation': 'Aerpio Pharmaceuticals, Cincinnati, Ohio, USA.'}, {'ForeName': 'Eric M', 'Initials': 'EM', 'LastName': 'Moult', 'Affiliation': 'Massachusetts Institute of Technology, Cambridge, Massachusetts, USA.'}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Fujimoto', 'Affiliation': 'Massachusetts Institute of Technology, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Nadia K', 'Initials': 'NK', 'LastName': 'Waheed', 'Affiliation': 'New England Eye Center, Boston, Massachusetts, USA. Electronic address: nadiakwaheed@gmail.com.'}]",American journal of ophthalmology,['10.1016/j.ajo.2020.06.009']
1128,32544846,"A fructose-based meal challenge to assess metabotypes and their metabolic risk profile: A randomized, crossover, controlled trial.","OBJECTIVES


The first aim of this study was to determine the metabolic type of individuals based on the postprandial metabolic response after the ingestion of a meal challenge that was high protein and either high glucose (high GI) or fructose (low GI). The second aim was to compare the baseline characteristics between the different metabolic types (metabotypes). The third aim was to assess whether the inclusion of fructose or glucose in a high-protein breakfast modulated the glucose, insulin, and TG response over a 4-h period.
METHODS


The study included 46 Asian women with a body mass index between 17 and 28 kg/m 2  in a randomized crossover design. Metabolic typing was based on the assessment of the postprandial glycemic, insulin and triacylglycerol (TG) response after the ingestion of two high-protein meal challenges either high in fructose or glucose. Baseline characteristics were compared between the different metabolic types. Baseline and 4-h postprandial blood samples were collected and glucose, insulin, and TG levels were analyzed. Cluster analysis was used to phenotype the participants in distinct groups. Baseline characteristics including anthropometry, glycemic, and lipid profiles and resting metabolic rate were compared among the metabolic types.
RESULTS


Cluster analysis revealed that women could be grouped into three metabolic types based on postprandial glucose, insulin, and TG response after the fructose meal challenge: cluster 1 with an average glucose + high TG response (highTG; n = 12), cluster 2 with a high glucose + average TG response (highGLU; n = 8), and cluster 3 with an average glucose + average TG response (Avg; n = 26). Post hoc analysis revealed significantly greater waist-to-hip ratio and a worse lipid profile for the highTG cluster and a higher fasting blood glucose, body mass index, fat percentage, and hip circumference in the highGLU cluster.
CONCLUSIONS


Three metabolic types with a distinct metabolic response could be distinguished after a high fructose meal. The results suggest a different risk profile and may indicate why some people develop diabetes in an obesogenic environment. Improved metabolic-type assessments will enable us to develop and optimize nutritional and medical interventions for individuals with differing diabetes risk.",2020,"Post hoc analysis revealed significantly greater waist-to-hip ratio and a worse lipid profile for the highTG cluster and a higher fasting blood glucose, body mass index, fat percentage, and hip circumference in the highGLU cluster.
","['46 Asian women with a body mass index between 17 and 28 kg/m 2', 'individuals with differing diabetes risk']","['high glucose (high GI) or fructose (low GI', 'fructose-based meal challenge']","['waist-to-hip ratio', 'fasting blood glucose, body mass index, fat percentage, and hip circumference', 'glucose, insulin, and TG levels', 'glucose, insulin, and TG response', 'postprandial glycemic, insulin and triacylglycerol (TG) response', 'Baseline and 4-h postprandial blood samples', 'postprandial glucose, insulin, and TG response', 'anthropometry, glycemic, and lipid profiles and resting metabolic rate', 'postprandial metabolic response']","[{'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]","[{'cui': 'C0860803', 'cui_str': 'Glucose increased'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0016745', 'cui_str': 'Fructose'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1998602', 'cui_str': 'Meals'}]","[{'cui': 'C0205682', 'cui_str': 'Waist/hip ratio'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0562350', 'cui_str': 'Hip circumference'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C4082350', 'cui_str': 'Resting Metabolic Rate'}]",46.0,0.0341195,"Post hoc analysis revealed significantly greater waist-to-hip ratio and a worse lipid profile for the highTG cluster and a higher fasting blood glucose, body mass index, fat percentage, and hip circumference in the highGLU cluster.
","[{'ForeName': 'Stefan Gerardus', 'Initials': 'SG', 'LastName': 'Camps', 'Affiliation': 'Singapore Institute of Food and Biotechnology Innovation, Agency for Science, Technology and Research and National University Health System, Singapore.'}, {'ForeName': 'Huann Rong', 'Initials': 'HR', 'LastName': 'Koh', 'Affiliation': 'Singapore Institute of Food and Biotechnology Innovation, Agency for Science, Technology and Research and National University Health System, Singapore.'}, {'ForeName': 'Nan Xin', 'Initials': 'NX', 'LastName': 'Wang', 'Affiliation': 'Singapore Institute of Food and Biotechnology Innovation, Agency for Science, Technology and Research and National University Health System, Singapore.'}, {'ForeName': 'Christiani Jeyakumar', 'Initials': 'CJ', 'LastName': 'Henry', 'Affiliation': 'Singapore Institute of Food and Biotechnology Innovation, Agency for Science, Technology and Research and National University Health System, Singapore; Department of Biochemistry, Yong Loo Lin School of Medicine, National University of Singapore, Singapore. Electronic address: jeya_henry@sifbi.a-star.edu.sg.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2020.110799']
1129,32544854,Effect of ZNF804A gene polymorphism (rs1344706) on the plasticity of the functional coupling between the right dorsolateral prefrontal cortex and the contralateral hippocampal formation.,"ZNF804A has now been recognized as a schizophrenia risk gene by multiple genome-wide association studies with its intronic polymorphism rs1344706 being reported as the first genome-wide significant risk variant for schizophrenia. Although the functional impact of this gene is still unknown, rs1344706's contribution to the functional coupling between the right dorsolateral prefrontal cortex (DLPFC) and the contralateral hippocampal formation (HF) has been reported by several studies. The current study tested whether the right DLPFC-left HF functional coupling showed plasticity during cognitive training (Study I) and whether rs1344706 affected the plasticity (Study II). In Study I, we conducted a randomized controlled trial with 30 subjects receiving 20 sessions of adaptive training on a memory span task (the training group) and 30 subjects practicing on a non-adaptive easy version of the same memory span task for 20 sessions (the control group). All subjects were scanned using fMRI before and after the training. Analyses of resting-state and task-state fMRI data consistently showed that the adaptive memory span training significantly strengthened the right DLPFC-left HF functional coupling. In Study II, we conducted a genetic association study with 101 subjects (combining the data from the training group in Study I with those from an additional subsequent sample of 71 subjects who received the same training and fMRI scans). Results showed that rs1344706 was significantly associated with training-induced changes in functional coupling. Subjects carrying the non-risk allele (C) of rs1344706 showed greater training-induced plasticity than the risk allele (A) homozygotes. These findings expanded our current understanding of the functional impact of the schizophrenia risk variant of ZNF804A gene and suggested that the ZNF804A gene could be used as a prospective target for future antipsychotic drugs and clinical research.",2020,Subjects carrying the non-risk allele (C) of rs1344706 showed greater training-induced plasticity than the risk allele (A) homozygotes.,"['101 subjects (combining the data from the training group in Study', '71 subjects who received the same training and fMRI scans', '30 subjects receiving 20 sessions of adaptive training on a memory span task (the training group) and 30 subjects practicing on a non-adaptive easy version of the same memory span task for 20 sessions (the control group']","['ZNF804A', 'ZNF804A gene polymorphism (rs1344706']",['functional coupling'],"[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0332219', 'cui_str': 'Easy'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0032529', 'cui_str': 'Genetic polymorphism'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}]",101.0,0.0118036,Subjects carrying the non-risk allele (C) of rs1344706 showed greater training-induced plasticity than the risk allele (A) homozygotes.,"[{'ForeName': 'Wan', 'Initials': 'W', 'LastName': 'Zhao', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, PR China.'}, {'ForeName': 'Xiongying', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'The National Clinical Research Center for Mental Disorders & Beijing Key Laboratory of Mental Disorders & Beijing Institute for Brain Disorders Center of Schizophrenia, Beijing Anding Hospital, Capital Medical University, Beijing 100088, PR China.'}, {'ForeName': 'Qiumei', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, PR China; School of Mental Health, Jining Medical University, 45# Jianshe South Road, Jining 272013, Shandong Province, PR China.'}, {'ForeName': 'Boqi', 'Initials': 'B', 'LastName': 'Du', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, PR China.'}, {'ForeName': 'Xiaoxiang', 'Initials': 'X', 'LastName': 'Deng', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, PR China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Ji', 'Affiliation': 'School of Mental Health, Jining Medical University, 45# Jianshe South Road, Jining 272013, Shandong Province, PR China.'}, {'ForeName': 'Yu-Tao', 'Initials': 'YT', 'LastName': 'Xiang', 'Affiliation': 'Faculty of Health Sciences, University of Macau, Avenida da Universidade, Taipa, Macau, PR China.'}, {'ForeName': 'Chuanyue', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'The National Clinical Research Center for Mental Disorders & Beijing Key Laboratory of Mental Disorders & Beijing Institute for Brain Disorders Center of Schizophrenia, Beijing Anding Hospital, Capital Medical University, Beijing 100088, PR China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Dong', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, PR China.'}, {'ForeName': 'Chuansheng', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Department of Psychological Science, University of California, Irvine, CA 92697, United States.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, PR China. Electronic address: lijundp@bnu.edu.cn.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2020.102279']
1130,32562721,Lower Adenoma Miss Rate of Computer-Aided Detection-Assisted Colonoscopy vs Routine White-Light Colonoscopy in a Prospective Tandem Study.,"BACKGROUND AND AIMS


Up to 30% of adenomas might be missed during screening colonoscopy-these could be polyps that appear on-screen but are not recognized by endoscopists or polyps that are in locations that do not appear on the screen at all. Computer-aided detection (CADe) systems, based on deep learning, might reduce rates of missed adenomas by displaying visual alerts that identify precancerous polyps on the endoscopy monitor in real time. We compared adenoma miss rates of CADe colonoscopy vs routine white-light colonoscopy.
METHODS


We performed a prospective study of patients, 18-75 years old, referred for diagnostic, screening, or surveillance colonoscopies at a single endoscopy center of Sichuan Provincial People's Hospital from June 3, 2019 through September 24, 2019. Same day, tandem colonoscopies were performed for each participant by the same endoscopist. Patients were randomly assigned to groups that received either CADe colonoscopy (n=184) or routine colonoscopy (n=185) first, followed immediately by the other procedure. Endoscopists were blinded to the group each patient was assigned to until immediately before the start of each colonoscopy. Polyps that were missed by the CADe system but detected by endoscopists were classified as missed polyps. False polyps were those continuously traced by the CADe system but then determined not to be polyps by the endoscopists. The primary endpoint was adenoma miss rate, which was defined as the number of adenomas detected in the second-pass colonoscopy divided by the total number of adenomas detected in both passes.
RESULTS


The adenoma miss rate was significantly lower with CADe colonoscopy (13.89%; 95% CI, 8.24%-19.54%) than with routine colonoscopy (40.00%; 95% CI, 31.23%-48.77%, P<.0001). The polyp miss rate was significantly lower with CADe colonoscopy (12.98%; 95% CI, 9.08%-16.88%) than with routine colonoscopy (45.90%; 95% CI, 39.65%-52.15%) (P<.0001). Adenoma miss rates in ascending, transverse, and descending colon were significantly lower with CADe colonoscopy than with routine colonoscopy (ascending colon 6.67% vs 39.13%; P=.0095; transverse colon 16.33% vs 45.16%; P=.0065; and descending colon 12.50% vs 40.91%, P=.0364).
CONCLUSIONS


CADe colonoscopy reduced the overall miss rate of adenomas by endoscopists using white-light endoscopy. Routine use of CADe might reduce the incidence of interval colon cancers. chictr.org.cn study no: ChiCTR1900023086.",2020,"The polyp miss rate significantly lower with CADe colonoscopy (12.98%; 95% CI, 9.08%-16.88%) than with routine colonoscopy (45.90%; 95% CI, 39.65%-52.15%) (P<.0001).","[""patients, 18-75 years old, referred for diagnostic, screening, or surveillance colonoscopies at a single endoscopy center of Sichuan Provincial People's Hospital from June 3, 2019 through September 24, 2019""]","['CADe colonoscopy', 'Computer-aided Detection-Assisted Colonoscopy vs Routine White-Light Colonoscopy', 'CADe colonoscopy (n=184) or routine colonoscopy', 'CADe colonoscopy vs routine white-light colonoscopy', 'CADe']","['adenoma miss rate', 'Adenoma miss rates in ascending, transverse, and descending colon', 'incidence of interval colon cancers']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0563228', 'cui_str': 'White light'}]","[{'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0205385', 'cui_str': 'Ascending'}, {'cui': 'C0205106', 'cui_str': 'Transverse plane'}, {'cui': 'C0227389', 'cui_str': 'Descending colon structure'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0007102', 'cui_str': 'Malignant tumor of colon'}]",,0.0444084,"The polyp miss rate significantly lower with CADe colonoscopy (12.98%; 95% CI, 9.08%-16.88%) than with routine colonoscopy (45.90%; 95% CI, 39.65%-52.15%) (P<.0001).","[{'ForeName': 'Pu', 'Initials': 'P', 'LastName': 'Wang', 'Affiliation': ""Department of Gastroenterology, Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, Chengdu, China.""}, {'ForeName': 'Peixi', 'Initials': 'P', 'LastName': 'Liu', 'Affiliation': ""Department of Gastroenterology, Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, Chengdu, China.""}, {'ForeName': 'Jeremy R', 'Initials': 'JR', 'LastName': 'Glissen Brown', 'Affiliation': 'Center for Advanced Endoscopy, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Tyler M', 'Initials': 'TM', 'LastName': 'Berzin', 'Affiliation': 'Center for Advanced Endoscopy, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Guanyu', 'Initials': 'G', 'LastName': 'Zhou', 'Affiliation': ""Department of Gastroenterology, Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, Chengdu, China.""}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Lei', 'Affiliation': ""Department of Gastroenterology, Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, Chengdu, China.""}, {'ForeName': 'Xiaogang', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': ""Department of Gastroenterology, Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, Chengdu, China.""}, {'ForeName': 'Liangping', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': ""Department of Gastroenterology, Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, Chengdu, China.""}, {'ForeName': 'Xun', 'Initials': 'X', 'LastName': 'Xiao', 'Affiliation': ""Department of Gastroenterology, Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, Chengdu, China. Electronic address: xiaoxun001@outlook.com.""}]",Gastroenterology,['10.1053/j.gastro.2020.06.023']
1131,32565319,Efficacy of Dose-Escalated Chemoradiation on Complete Tumor Response in Patients with Locally Advanced Rectal Cancer (RECTAL-BOOST): A Phase 2 Randomized Controlled Trial.,"PURPOSE


Pathologic complete tumor response after chemoradiation in patients with locally advanced rectal cancer (LARC) is associated with a favorable prognosis and allows organ-sparing treatment strategies. In the RECTAL-BOOST trial, we aimed to investigate the effect of an external radiation boost to the tumor before chemoradiation on pathologic or sustained clinical complete tumor response in LARC.
METHODS AND MATERIALS


This multicenter, nonblinded, phase 2 randomized controlled trial followed the trials-within-cohorts design, which is a pragmatic trial design allowing cohort participants to be randomized for an experimental intervention. Patients in the intervention group are offered the intervention (and can either accept or refuse this), whereas patients in the control group are not notified about the randomization. Participants of a colorectal cancer cohort referred for chemoradiation of LARC to either of 2 radiation therapy centers were eligible. Patients were randomized to no boost or an external radiation boost (5 × 3 Gy) without concurrent chemotherapy, directly followed by standard pelvic chemoradiation (25 × 2 Gy with concurrent capecitabine). The primary outcome was pathologic complete response (ie, ypT0N0) in patients with planned surgery at 12 weeks, or, as surrogate for pathologic complete response, a 2-year sustained clinical complete response for patients treated with an organ preservation strategy. Analyses were intention to treat. The study was registered with ClinicalTrials.gov, number NCT01951521.
RESULTS


Between September 2014 and July 2018, 128 patients were randomized. Fifty-one of the 64 (79.7%) patients in the intervention group accepted and received a boost. Compared with the control group, fewer patients in the intervention group had a cT4 stage and a low rectal tumor (31.3% vs 17.2% and 56.3% vs 45.3%, respectively), and more patients had a cN2 stage (59.4% vs 70.3%, respectively). Rate of pathologic or sustained clinical complete tumor response was similar between the groups: 23 of 64 (35.9%; 95% confidence interval [CI], 24.3-48.9) in the intervention group versus 24 of 64 (37.5%; 95% CI, 25.7-50.5) in the control group (odds ratio [OR] = 0.94; 95% CI, 0.46-1.92). Near-complete or complete tumor regression was more common in the intervention group (34 of 49; 69.4%) than in the control group (24 of 53; 45.3%; (OR = 2.74, 95% CI 1.21-6.18). Grade ≥3 acute toxicity was comparable: 6 of 64 (9.4%) in the intervention group versus 5 of 64 (7.8%) in the control group (OR = 1.22; 95% CI, 0.35-4.22).
CONCLUSIONS


Dose escalation with an external radiation therapy boost to the tumor before neoadjuvant chemoradiation did not increase the pathologic or sustained clinical complete tumor response rate in LARC.",2020,"Compared with the control group, fewer patients in the intervention group had a cT4-stage and a low rectal tumour (31.3% versus 17.2% and 56.3% versus 45.3% respectively), and more patients had a cN2-stage (59.4% versus 70.3% respectively).","['patients with locally advanced rectal cancer (RECTAL-BOOST', 'Between Sept 2014 and July 2018, 128 patients were randomised', 'patients with locally advanced rectal cancer', 'Participants of a colorectal cancer cohort referred for chemoradiation of LARC to either of two radiotherapy centres were eligible']","['external radiation boost', 'external radiotherapy', 'external radiation boost (5 x 3 Gy) without concurrent chemotherapy directly followed by standard pelvic chemoradiation (25 x 2 Gy with concurrent capecitabine', 'dose-escalated chemoradiation']","['Rate of pathological or sustained clinical complete tumour response', 'pathological complete response (pCR, i.e. ypT0N0', 'cN2-stage', 'complete tumour response', 'cT4-stage and a low rectal tumour', 'Grade >3 acute toxicity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C2919491', 'cui_str': 'Boost radiation therapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0040539', 'cui_str': 'TO'}]",128.0,0.233842,"Compared with the control group, fewer patients in the intervention group had a cT4-stage and a low rectal tumour (31.3% versus 17.2% and 56.3% versus 45.3% respectively), and more patients had a cN2-stage (59.4% versus 70.3% respectively).","[{'ForeName': 'Alice M', 'Initials': 'AM', 'LastName': 'Couwenberg', 'Affiliation': 'Department of Radiation Oncology, University Medical Center Utrecht, Utrecht, the Netherlands. Electronic address: A.M.Couwenberg@umcutrecht.nl.'}, {'ForeName': 'Johannes P M', 'Initials': 'JPM', 'LastName': 'Burbach', 'Affiliation': 'Department of Surgery, Medical Center Leeuwarden, the Netherlands.'}, {'ForeName': 'Maaike', 'Initials': 'M', 'LastName': 'Berbee', 'Affiliation': 'Department of Radiation Oncology (MAASTRO), GROW School for Oncology and Developmental Biology, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Miangela M', 'Initials': 'MM', 'LastName': 'Lacle', 'Affiliation': 'Department of Pathology, University Medical Center Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Arensman', 'Affiliation': 'Department of Pathology, Meander Medical Centre, Amersfoort, the Netherlands.'}, {'ForeName': 'Mihaela G', 'Initials': 'MG', 'LastName': 'Raicu', 'Affiliation': 'Department of Pathology, St. Antonius Hospital, Nieuwegein, the Netherlands.'}, {'ForeName': 'Frank J', 'Initials': 'FJ', 'LastName': 'Wessels', 'Affiliation': 'Department of Radiology, University Medical Center Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Verdult', 'Affiliation': 'Department of Radiology, University Medical Center Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Jeanine', 'Initials': 'J', 'LastName': 'Roodhart', 'Affiliation': 'Department of Medical Oncology, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Onne', 'Initials': 'O', 'LastName': 'Reerink', 'Affiliation': 'Department of Radiation Oncology, Insala Clinic, Zwolle, The Netherlands.'}, {'ForeName': 'Sieske', 'Initials': 'S', 'LastName': 'Hoendervangers', 'Affiliation': 'Department of Radiation Oncology, University Medical Center Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Buijsen', 'Affiliation': 'Department of Radiation Oncology (MAASTRO), GROW School for Oncology and Developmental Biology, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Heike I', 'Initials': 'HI', 'LastName': 'Grabsch', 'Affiliation': ""Department of Pathology, GROW School for Oncology and Developmental Biology, Maastricht University Medical Centre, Maastricht, The Netherlands; Pathology and Data Analytics, Leeds Institute of Medical Research at St James's, University of Leeds, Leeds, United Kingdom.""}, {'ForeName': 'Apollo', 'Initials': 'A', 'LastName': 'Pronk', 'Affiliation': 'Department of Surgery, Diakonessenhuis, Utrecht, The Netherlands.'}, {'ForeName': 'Esther C J', 'Initials': 'ECJ', 'LastName': 'Consten', 'Affiliation': 'Department of Surgery, Meander Medical Center, Amersfoort, The Netherlands; Department of Surgery, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Anke B', 'Initials': 'AB', 'LastName': 'Smits', 'Affiliation': 'Department of Surgery, St. Antonius Hospital, Nieuwegein, The Netherlands.'}, {'ForeName': 'Joost T', 'Initials': 'JT', 'LastName': 'Heikens', 'Affiliation': 'Department of Surgery, Hospital Rievierenland, Tiel, The Netherlands.'}, {'ForeName': 'Ane L', 'Initials': 'AL', 'LastName': 'Appelt', 'Affiliation': ""Radiotherapy Research Group, Leeds Institute of Medicine at St James's, University of Leeds, Leeds, United Kingdom; Leeds Cancer Centre, St James University Hospital, Leeds, United Kingdom.""}, {'ForeName': 'Wilhelmina M U', 'Initials': 'WMU', 'LastName': 'van Grevenstein', 'Affiliation': 'Department of Surgery, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Helena M', 'Initials': 'HM', 'LastName': 'Verkooijen', 'Affiliation': 'Imaging Division, University Medical Center Utrecht, Utrecht, The Netherlands; Faculty of Medicine, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Martijn P W', 'Initials': 'MPW', 'LastName': 'Intven', 'Affiliation': 'Department of Radiation Oncology, University Medical Center Utrecht, Utrecht, the Netherlands.'}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2020.06.013']
1132,32571614,Effects of diet and exercise on adipocytokine levels in patients with moderate to severe chronic kidney disease.,"BACKGROUND AND AIMS


Obesity is a pro-inflammatory risk factor for progression of CKD and cardiovascular disease. We hypothesized that implementation of caloric restriction and endurance exercise would improve adipocytokine profiles in patients with moderate to severe CKD.
METHODS AND RESULTS


We enrolled patients with moderate to severe CKD through a multi-center pilot randomized trial of diet and exercise in a 4-arm design (dietary restriction of 10%-15% reduction in caloric intake, exercise three times/week, combined diet and exercise, and control) (NCT01150851). Adipocytokines (adiponectin and leptin) were measured at the beginning and end of the study period as secondary outcomes. Treatment effect was analyzed in a multivariable model adjusted for baseline outcome values, age, gender, site and diabetes. A total of 122 participants were consented, 111 were randomized (42% female, 25% diabetic, and 91% hypertensive), 104 started intervention and 92 completed the study (Figure 1). Plasma adiponectin levels increased significantly in response to diet by 23% (95% CI: 0.2%, 49.8%, p = 0.048) among participants randomized to the caloric restriction and usual activity arm but not to exercise, whereas circulating leptin did not change by either treatment.
CONCLUSION


Our data suggest that dietary caloric restriction increases plasma adiponectin levels in stage 3-4 CKD patients, with limited effect on leptin levels. These findings suggest the potential for improving the metabolic milieu of CKD with moderate calorie restriction.",2020,"Plasma adiponectin levels increased significantly in response to diet by 23% (95% CI: 0.2%, 49.8%, p = 0.048) among participants randomized to the caloric restriction and usual activity arm but not to exercise, whereas circulating leptin did not change by either treatment.
","['A total of 122 participants were consented, 111 were randomized (42% female, 25% diabetic, and 91% hypertensive), 104 started intervention and 92 completed the study (Figure\xa01', 'enrolled patients with moderate to severe CKD through a multi-center pilot randomized trial of', 'patients with moderate to severe CKD', 'patients with moderate to severe chronic kidney disease']","['diet and exercise', 'dietary caloric restriction', 'diet and exercise in a 4-arm design (dietary restriction of 10%-15% reduction in caloric intake, exercise three times/week, combined diet and exercise, and control) (NCT01150851', 'caloric restriction and endurance exercise']","['Adipocytokines (adiponectin and leptin', 'plasma adiponectin levels', 'adipocytokine levels', 'Plasma adiponectin levels', 'circulating leptin', 'adipocytokine profiles', 'leptin levels']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1135809', 'cui_str': 'Decreased energy diet'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0456698', 'cui_str': 'times/week'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0419120', 'cui_str': 'Muscular endurance development exercise'}]","[{'cui': 'C1955907', 'cui_str': 'Adipokine'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}]",122.0,0.0257898,"Plasma adiponectin levels increased significantly in response to diet by 23% (95% CI: 0.2%, 49.8%, p = 0.048) among participants randomized to the caloric restriction and usual activity arm but not to exercise, whereas circulating leptin did not change by either treatment.
","[{'ForeName': 'Nihal', 'Initials': 'N', 'LastName': 'Aydemir', 'Affiliation': 'Hitit University Medical School, Nephrology Department, Corum, Turkey.'}, {'ForeName': 'Mindy M', 'Initials': 'MM', 'LastName': 'Pike', 'Affiliation': ""Vanderbilt O'Brien Kidney Center, Division of Nephrology and Hypertension, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA; Division of Epidemiology, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.""}, {'ForeName': 'Aseel', 'Initials': 'A', 'LastName': 'Alsouqi', 'Affiliation': ""Vanderbilt O'Brien Kidney Center, Division of Nephrology and Hypertension, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.""}, {'ForeName': 'Samuel A E', 'Initials': 'SAE', 'LastName': 'Headley', 'Affiliation': 'Department of Exercise Science and Athletic Training, Springfield College, Springfield, MA, USA.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Tuttle', 'Affiliation': 'Kidney Research Institute, Division of Nephrology, Department of Medicine, University of Washington, Seattle, WA, USA; Providence Medical Research Center, Providence Health Care, Spokane, WA, USA.'}, {'ForeName': 'Elizabeth E', 'Initials': 'EE', 'LastName': 'Evans', 'Affiliation': 'Department of Exercise Science and Athletic Training, Springfield College, Springfield, MA, USA.'}, {'ForeName': 'Charles M', 'Initials': 'CM', 'LastName': 'Milch', 'Affiliation': 'Department of Exercise Science and Athletic Training, Springfield College, Springfield, MA, USA.'}, {'ForeName': 'Kelsey A', 'Initials': 'KA', 'LastName': 'Moody', 'Affiliation': 'Department of Exercise Science and Athletic Training, Springfield College, Springfield, MA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Germain', 'Affiliation': 'Department of Nephrology, Bay State Medical Center, Springfield, MA, USA.'}, {'ForeName': 'Loren', 'Initials': 'L', 'LastName': 'Lipworth', 'Affiliation': ""Vanderbilt O'Brien Kidney Center, Division of Nephrology and Hypertension, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA; Division of Epidemiology, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.""}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Himmelfarb', 'Affiliation': 'Kidney Research Institute, Division of Nephrology, Department of Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'T A', 'Initials': 'TA', 'LastName': 'Ikizler', 'Affiliation': ""Vanderbilt O'Brien Kidney Center, Division of Nephrology and Hypertension, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.""}, {'ForeName': 'Cassianne', 'Initials': 'C', 'LastName': 'Robinson-Cohen', 'Affiliation': ""Vanderbilt O'Brien Kidney Center, Division of Nephrology and Hypertension, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA. Electronic address: cassianne.robinson-cohen@vumc.edu.""}]","Nutrition, metabolism, and cardiovascular diseases : NMCD",['10.1016/j.numecd.2020.04.012']
1133,32447575,Feasibility of eccentric overloading and neuromuscular electrical stimulation to improve muscle strength and muscle mass after treatment for head and neck cancer.,"PURPOSE


Treatment of head and neck cancer (HNC) results in severe weight loss, mainly due to the loss of lean body mass. Consequently, decreases in muscular strength and health-related quality of life (HRQL) occur. This study investigated the feasibility of a 12-week novel strength training (NST) and conventional strength training (CST) intervention delivered after HNC treatment.
METHODS


Participants were randomized to a NST group (n = 11) involving eccentric overloaded strength training and neuromuscular electrical stimulation (NMES), or a CST group (n = 11) involving dynamic resistance exercises matched for training volume. Feasibility outcomes included recruitment, completion, adherence, and evidence of progression. A neuromuscular assessment involving maximal isometric voluntary contractions (MIVCs) in the knee extensors was evaluated prior to and during incremental cycling to volitional exhaustion at baseline and after the interventions. Anthropometrics and patient-reported outcomes (PROs) were also assessed.
RESULTS


Although recruitment was challenging, completion was 100% in NST and 82% in CST. Adherence was 92% in NST and 81% in CST. Overall, MIVC increased by 19 ± 23%, muscle cross-sectional area improved 18 ± 22%, cycling exercise time improved by 18 ± 13%, and improvements in HRQL and fatigue were clinically relevant.
CONCLUSIONS


Both interventions were found to be feasible for HNC patients after treatment. Strength training significantly improved maximal muscle strength, muscle cross-sectional area, and PROs after HNC treatment. Future research should include fully powered trials and consider the use of eccentric overloading and NMES during HNC treatment.
IMPLICATIONS FOR CANCER SURVIVORS


Eccentric- and NMES-emphasized strength training may be useful alternatives to conventional strength training after HNC treatment.",2020,"Overall, MIVC increased by 19 ± 23%, muscle cross-sectional area improved 18 ± 22%, cycling exercise time improved by 18 ± 13%, and improvements in HRQL and fatigue were clinically relevant.
","['head and neck cancer', 'head and neck cancer (HNC', 'Participants']","['Strength training', 'neuromuscular assessment involving maximal isometric voluntary contractions (MIVCs', 'eccentric overloaded strength training and neuromuscular electrical stimulation (NMES), or a CST group (n = 11) involving dynamic resistance exercises matched for training volume', 'NST', 'novel strength training (NST) and conventional strength training (CST) intervention', 'eccentric overloading and neuromuscular electrical stimulation']","['muscle strength and muscle mass', 'cycling exercise time', 'recruitment, completion, adherence, and evidence of progression', 'HRQL and fatigue', 'Overall, MIVC', 'maximal muscle strength, muscle cross-sectional area, and PROs', 'muscular strength and health-related quality of life (HRQL', 'Adherence']","[{'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0439740', 'cui_str': 'Eccentric'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0439587', 'cui_str': 'Exercise time'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}]",,0.0241508,"Overall, MIVC increased by 19 ± 23%, muscle cross-sectional area improved 18 ± 22%, cycling exercise time improved by 18 ± 13%, and improvements in HRQL and fatigue were clinically relevant.
","[{'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Lavigne', 'Affiliation': 'Faculty of Kinesiology, University of Calgary, Calgary, Canada.'}, {'ForeName': 'Rosie', 'Initials': 'R', 'LastName': 'Twomey', 'Affiliation': 'Faculty of Kinesiology, University of Calgary, Calgary, Canada.'}, {'ForeName': 'Harold', 'Initials': 'H', 'LastName': 'Lau', 'Affiliation': 'Department of Oncology, Cumming School of Medicine, University of Calgary, Calgary, Canada.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Francis', 'Affiliation': 'Division of Physical Medicine & Rehabilitation, Cumming School of Medicine, University of Calgary, Calgary, Canada.'}, {'ForeName': 'S Nicole', 'Initials': 'SN', 'LastName': 'Culos-Reed', 'Affiliation': 'Faculty of Kinesiology, University of Calgary, Calgary, Canada.'}, {'ForeName': 'Guillaume Y', 'Initials': 'GY', 'LastName': 'Millet', 'Affiliation': 'Faculty of Kinesiology, University of Calgary, Calgary, Canada. guillaume.millet@univ-st-etienne.fr.'}]",Journal of cancer survivorship : research and practice,['10.1007/s11764-020-00893-9']
1134,32576090,Telemedicine Cognitive Behavioral Therapy for Anxiety After Stroke: Proof-of-Concept Randomized Controlled Trial.,"BACKGROUND AND PURPOSE


Disabling anxiety affects a quarter of stroke survivors but access to treatment is poor. We developed a telemedicine model for delivering guided self-help cognitive behavioral therapy (CBT) for anxiety after stroke (TASK-CBT). We aimed to evaluate the feasibility of TASK-CBT in a randomized controlled trial workflow that enabled all trial procedures to be carried out remotely. In addition, we explored the feasibility of wrist-worn actigraphy sensor as a way of measuring objective outcomes in this clinical trial.
METHODS


We recruited adult community-based stroke patients (n=27) and randomly allocated them to TASK-CBT (n=14) or relaxation therapy (TASK-Relax), an active comparator (n=13).
RESULTS


In our sample (mean age 65 [±10]; 56% men; 63% stroke, 37% transient ischemic attacks), remote self-enrolment, electronic signature, intervention delivery, and automated follow-up were feasible. All participants completed all TASK-CBT sessions (14/14). Lower levels of anxiety were observed in TASK-CBT when compared with TASK-Relax at both weeks 6 and 20. Mean actigraphy sensor wearing-time was 33 days (±15).
CONCLUSIONS


Our preliminary feasibility data from the current study support a larger definitive clinical trial and the use of wrist-worn actigraphy sensor in anxious stroke survivors. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT03439813.",2020,Lower levels of anxiety were observed in TASK-CBT when compared with TASK-Relax at both weeks 6 and 20.,"['anxious stroke survivors', 'In our sample (mean age 65 [±10]; 56% men; 63% stroke, 37% transient ischemic attacks), remote self-enrolment, electronic signature, intervention delivery, and automated follow-up were feasible', 'adult community-based stroke patients (n=27']","['telemedicine model for delivering guided self-help cognitive behavioral therapy (CBT', 'Telemedicine Cognitive Behavioral Therapy', 'TASK-CBT', 'relaxation therapy (TASK-Relax), an active comparator (n=13', 'wrist-worn actigraphy sensor']","['Mean actigraphy sensor wearing-time', 'Lower levels of anxiety', 'Anxiety']","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C2733435', 'cui_str': 'Guided self-help cognitive behavioral therapy'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0282333', 'cui_str': 'Relaxation training therapy'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.157782,Lower levels of anxiety were observed in TASK-CBT when compared with TASK-Relax at both weeks 6 and 20.,"[{'ForeName': 'Ho-Yan Yvonne', 'Initials': 'HY', 'LastName': 'Chun', 'Affiliation': 'Centre for Clinical Brain Sciences (H.Y.Y.C., A.J.C., M.S.D., G.E.M., W.N.W.), University of Edinburgh, UK.'}, {'ForeName': 'Alan J', 'Initials': 'AJ', 'LastName': 'Carson', 'Affiliation': 'Centre for Clinical Brain Sciences (H.Y.Y.C., A.J.C., M.S.D., G.E.M., W.N.W.), University of Edinburgh, UK.'}, {'ForeName': 'Athanasios', 'Initials': 'A', 'LastName': 'Tsanas', 'Affiliation': 'Centre for Medical Informatics, Usher Institute (A.T.), University of Edinburgh, UK.'}, {'ForeName': 'Martin S', 'Initials': 'MS', 'LastName': 'Dennis', 'Affiliation': 'Centre for Clinical Brain Sciences (H.Y.Y.C., A.J.C., M.S.D., G.E.M., W.N.W.), University of Edinburgh, UK.'}, {'ForeName': 'Gillian E', 'Initials': 'GE', 'LastName': 'Mead', 'Affiliation': 'Centre for Clinical Brain Sciences (H.Y.Y.C., A.J.C., M.S.D., G.E.M., W.N.W.), University of Edinburgh, UK.'}, {'ForeName': 'Clementina', 'Initials': 'C', 'LastName': 'Calabria', 'Affiliation': 'Royal Infirmary of Edinburgh (C.C.), National Health Service Lothian, Edinburgh, UK.'}, {'ForeName': 'William N', 'Initials': 'WN', 'LastName': 'Whiteley', 'Affiliation': 'Centre for Clinical Brain Sciences (H.Y.Y.C., A.J.C., M.S.D., G.E.M., W.N.W.), University of Edinburgh, UK.'}]",Stroke,['10.1161/STROKEAHA.120.029042']
1135,32442153,Evaluating Engagement in a Digital and Dietetic Intervention Promoting Healthy Weight Gain in Pregnancy: Mixed Methods Study.,"BACKGROUND


Early excess and inadequate gestational weight gain (GWG) have been associated with negative outcomes for mother and child. The use of digital media to deliver pregnancy lifestyle interventions is increasing, but there is little data on participant engagement. The Pregnancy Lifestyle Activity and Nutrition (PLAN) intervention pilot study was an electronic health and dietetic-delivered intervention program promoting healthy GWG in early pregnancy.
OBJECTIVE


This study aims to explore the interactions of participants with the program and to assess its acceptability.
METHODS


This study uses both quantitative and qualitative methods using data from parent randomized controlled trial (ACTRN12617000725369). Quantitative data from 22 participants in the intervention arm who completed the study provided measures of the interactions participants had with the digital components of the program and with dietetic consultations. A descriptive qualitative analysis employed semistructured interviews with 9 participants to elicit views on the acceptability of the intervention and its components.
RESULTS


The electronic delivery of information and recording of weight from 8 to 20 weeks of gestation were universally accepted. Component (face-to-face dietitian, weight tracker, website information delivery, and SMS goal prompting) acceptability and engagement differed between individuals. A total of 4 key themes emerged from the qualitative analysis: supporting lifestyle change, component acceptability and value, delivery platforms, and engagement barriers.
CONCLUSIONS


The PLAN intervention and its delivery via a blend of personal dietetic consultations and digital program delivery was found to be acceptable and valuable to pregnant women. Individuals responded differently to various components, emphasizing the importance of including women in the development of lifestyle interventions and allowing participants to choose and tailor programs. Larger randomized controlled trials using these insights in a broader section of the community are needed to inform the iterative development of practical, time-efficient, and cost-effective ways of supporting optimal GWG with the potential to optimize outcomes for pregnant women and their child.",2020,The PLAN intervention and its delivery via a blend of personal dietetic consultations and digital program delivery was found to be acceptable and valuable to pregnant women.,"['pregnant women and their child', 'pregnant women', ""Women's Engagement With Pregnancy Lifestyle Activity and Nutrition"", '22 participants in the intervention arm who completed the study provided measures of the interactions participants had with the digital components of the program and with dietetic consultations']","['Electronic Health and Dietetic Intervention', 'electronic health and dietetic-delivered intervention program promoting healthy GWG']",[],"[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0012180', 'cui_str': 'Dietetics'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}]","[{'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0012180', 'cui_str': 'Dietetics'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}]",[],22.0,0.0728469,The PLAN intervention and its delivery via a blend of personal dietetic consultations and digital program delivery was found to be acceptable and valuable to pregnant women.,"[{'ForeName': 'Jane C', 'Initials': 'JC', 'LastName': 'Willcox', 'Affiliation': 'La Trobe University, Bundoora, Australia.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Chai', 'Affiliation': 'Telethon Kids Institute, Perth, Australia.'}, {'ForeName': 'Lawrence J', 'Initials': 'LJ', 'LastName': 'Beilin', 'Affiliation': 'The University of Western Australia, Perth, Australia.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Prescott', 'Affiliation': 'The University of Western Australia, Perth, Australia.'}, {'ForeName': 'Desiree', 'Initials': 'D', 'LastName': 'Silva', 'Affiliation': 'Joondalup Health Campus, Shenton Avenue, Perth, Australia.'}, {'ForeName': 'Cliff', 'Initials': 'C', 'LastName': 'Neppe', 'Affiliation': 'Joondalup Health Campus, Shenton Avenue, Perth, Australia.'}, {'ForeName': 'Rae-Chi', 'Initials': 'RC', 'LastName': 'Huang', 'Affiliation': 'Telethon Kids Institute, Perth, Australia.'}]",Journal of medical Internet research,['10.2196/17845']
1136,32448722,Discrete Fiber Structures Dictate Human Gut Bacteria Outcomes.,Supplementation with resistant starches of different structures led to divergent shifts in key bacterial taxa abundance and distinct butyrate or propionate outcomes. A recent randomized controlled trial (RCT) reported by Deehan et al. showed similar responses within treatment groups and dose-response plateauing at 35 g/d. These results support a proposed alignment of discrete dietary fiber (DF) structures with gut bacteria.,2020,Supplementation with resistant starches of different structures led to divergent shifts in key bacterial taxa abundance and distinct butyrate or propionate outcomes.,[],[],[],[],[],[],,0.0492586,Supplementation with resistant starches of different structures led to divergent shifts in key bacterial taxa abundance and distinct butyrate or propionate outcomes.,"[{'ForeName': 'Bruce R', 'Initials': 'BR', 'LastName': 'Hamaker', 'Affiliation': 'Whistler Center for Carbohydrate Research, Department of Food Science, Purdue University, West Lafayette, IN 47906, USA. Electronic address: hamakerb@purdue.edu.'}, {'ForeName': 'Thaisa Moro', 'Initials': 'TM', 'LastName': 'Cantu-Jungles', 'Affiliation': 'Whistler Center for Carbohydrate Research, Department of Food Science, Purdue University, West Lafayette, IN 47906, USA.'}]",Trends in endocrinology and metabolism: TEM,['10.1016/j.tem.2020.05.002']
1137,32565594,"Comparative evaluation of efficacy and tolerability of vilazodone, escitalopram, and amitriptyline in patients of major depressive disorder: A randomized, parallel, open-label clinical study.","OBJECTIVES


To evaluate and compare efficacy and tolerability of Vilazodone with Escitalopram and Amitriptyline in patients of major depressive disorder(MDD).
METHODS


This was a randomized, prospective, parallel-group, open label clinical study in which newly diagnosed patients of MDD were randomized to receive Tab Vilazodone 20 mg daily or Tab Escitalopram 20mg daily or Tab Amitriptyline 75mg daily for 12 weeks. Antidepressant activity was assessed by change in score from baseline to week 12 on HAMD-17 and MADRS scales while change in score on HAM-A scale was used to assess antianxiety effect. Change in scores on the three scales was also compared between the three treatment groups. Severity and causality of adverse events were assessed by the modified Hartwig & Siegel scale and Naranjo scale respectively. Data was analyzed in accordance with per protocol analysis.
RESULTS


Reduction in HAMD-17 and MADRS scores was significantly more in vilazodone group compared to the other two drugs indicating that vilazodone is more efficacious antidepressant. Number of remitters were also significantly more in the vilazodone group ( n =11) compared to escitalopram ( n =4) ( p <0.05) and amitriptyline ( n =0) ( p <0.001) at 12 weeks. Similar results were also obtained with HAM-A score. Number of patients showing MADRS sustained response at 12 weeks was statistically significantly more in vilazodone ( n =12) and escitalopram ( n =12) groups compared to amitriptyline ( n =01) ( p <0.001). Reported adverse events were constipation and sedation(amitriptyline group); nausea and headache(escitalopram and vilazodone groups). These adverse events were of mild severity. Most adverse events belonged to probable category.
CONCLUSION


Vilazodone is more efficacious and well tolerated antidepressant compared to escitalopram and amitriptyline.",2020,"RESULTS


Reduction in HAMD-17 and MADRS scores was significantly more in vilazodone group compared to the other two drugs indicating that vilazodone is more efficacious antidepressant.","['newly diagnosed patients of MDD', 'patients of major depressive disorder(MDD', 'patients of major depressive disorder']","['Vilazodone', 'Tab Vilazodone 20 mg daily or Tab Escitalopram 20mg daily or Tab Amitriptyline', 'vilazodone, escitalopram, and amitriptyline', 'Vilazodone with Escitalopram and Amitriptyline', 'amitriptyline', 'vilazodone']","['Antidepressant activity', 'antianxiety effect', 'Severity and causality of adverse events', 'efficacy and tolerability', 'HAMD-17 and MADRS scores', 'Number of remitters', 'MADRS sustained response']","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0011581', 'cui_str': 'Depressive disorder'}]","[{'cui': 'C1530072', 'cui_str': 'vilazodone'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1171041', 'cui_str': 'Escitalopram 20 MG'}, {'cui': 'C0002600', 'cui_str': 'Amitriptyline'}, {'cui': 'C1099456', 'cui_str': 'Escitalopram'}]","[{'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C3179404', 'cui_str': 'Anti-Anxiety Effects'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}]",,0.0467849,"RESULTS


Reduction in HAMD-17 and MADRS scores was significantly more in vilazodone group compared to the other two drugs indicating that vilazodone is more efficacious antidepressant.","[{'ForeName': 'Renuka L', 'Initials': 'RL', 'LastName': 'Kadam', 'Affiliation': 'Department of Pharmacology, Government Medical College, Nagpur, Maharashtra, India.'}, {'ForeName': 'Smita Dipak', 'Initials': 'SD', 'LastName': 'Sontakke', 'Affiliation': 'Department of Pharmacology, Government Medical College, Nagpur, Maharashtra, India.'}, {'ForeName': 'Prashant', 'Initials': 'P', 'LastName': 'Tiple', 'Affiliation': 'Department of Psychiatry, Government Medical College, Nagpur, Maharashtra, India.'}, {'ForeName': 'Vijay M', 'Initials': 'VM', 'LastName': 'Motghare', 'Affiliation': 'Department of Pharmacology, Government Medical College, Nagpur, Maharashtra, India.'}, {'ForeName': 'Chaitali S', 'Initials': 'CS', 'LastName': 'Bajait', 'Affiliation': 'Department of Pharmacology, Government Medical College, Nagpur, Maharashtra, India.'}, {'ForeName': 'Mrunalini V', 'Initials': 'MV', 'LastName': 'Kalikar', 'Affiliation': 'Department of Pharmacology, Government Medical College, Nagpur, Maharashtra, India.'}]",Indian journal of pharmacology,['10.4103/ijp.IJP_441_18']
1138,32565595,"Comparison of the efficacy of oral fenugreek seeds hydroalcoholic extract versus placebo in nonalcoholic fatty liver disease; a randomized, triple-blind controlled pilot clinical trial.","OBJECTIVES


The aim of this study is to investigate the therapeutic property of hydroalcoholic extract of Fenugreek seeds in nonalcoholic fatty liver disease (NAFLD) in adult patients.
METHODS


This randomized, placebo-controlled, parallel trial was conducted from November 2014 to June 2017. Patients aged between 18 and 70 years old with confirmed NAFLD were recruited from the Motahhari clinic, affiliated to Shiraz University of Medical Sciences, Iran. Participants either received 1 g hydroalcoholic extract of Fenugreek seeds or placebo daily for 3 months. The primary outcomes were changes in serum alanine transaminase and FibroScan controlled attenuation parameter score. Secondary outcome measures were changes in other laboratory data, liver stiffness measure, liver steatosis percent, and anthropometric variables. Participants were randomly assigned to the groups using blocked randomization method. Participants, investigators, and statistician were blinded to treatments allocation.
RESULTS


After screening eighty patients, thirty patients met the inclusion criteria and were divided into two groups (1:1). After 3 months, two and four patients did not complete the trial in Fenugreek and placebo group, respectively. The changes in the anthropometrics, laboratories and FibroScan measurements were not statistically significant between the two groups.
CONCLUSION


The evidence to prove the efficacy of the Fenugreek seeds' hydroalcoholic extract in NAFLD was not strong enough; hence, further experiments are still needed to assess the possible efficacy of Fenugreek on the treatment of NAFLD.",2020,"The changes in the anthropometrics, laboratories and FibroScan measurements were not statistically significant between the two groups.
","['nonalcoholic fatty liver disease', 'adult patients', 'Patients aged between 18 and 70 years old with confirmed NAFLD were recruited from the Motahhari clinic, affiliated to Shiraz University of Medical Sciences, Iran', 'After screening eighty patients, thirty patients met the inclusion criteria', 'November 2014 to June 2017']","['hydroalcoholic extract of Fenugreek seeds or placebo', 'hydroalcoholic extract of Fenugreek seeds', 'oral fenugreek seeds hydroalcoholic extract versus placebo', 'placebo']","['anthropometrics, laboratories and FibroScan measurements', 'changes in other laboratory data, liver stiffness measure, liver steatosis percent, and anthropometric variables', 'serum alanine transaminase and FibroScan controlled attenuation parameter score']","[{'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0453257', 'cui_str': 'Fenugreek seed'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0015695', 'cui_str': 'Fatty Liver'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.348075,"The changes in the anthropometrics, laboratories and FibroScan measurements were not statistically significant between the two groups.
","[{'ForeName': 'Amirhossein', 'Initials': 'A', 'LastName': 'Babaei', 'Affiliation': 'Student Research Committee, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Seyed Alireza', 'Initials': 'SA', 'LastName': 'Taghavi', 'Affiliation': 'Gastroenterohepatology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Mohammadi', 'Affiliation': 'Student Research Committee, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mohammad Amin', 'Initials': 'MA', 'LastName': 'Mahdiyar', 'Affiliation': 'Student Research Committee, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Pooya', 'Initials': 'P', 'LastName': 'Iranpour', 'Affiliation': 'Department of Radiology, Medical Imaging Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Fardad', 'Initials': 'F', 'LastName': 'Ejtehadi', 'Affiliation': 'Gastroenterohepatology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Abdolali', 'Initials': 'A', 'LastName': 'Mohagheghzadeh', 'Affiliation': 'Department of Phytopharmaceuticals (Traditional Pharmacy), School of Pharmacy, Pharmaceutical Sciences Research Center, Shiraz University of Medical Science, Shiraz, Iran.'}]",Indian journal of pharmacology,['10.4103/ijp.IJP_17_19']
1139,32569395,Fast effectiveness of a solubilized low-dose budesonide nasal spray in allergic rhinitis.,"BACKGROUND


Budesonide, a poorly water-soluble corticosteroid, is currently marketed as a suspension. Budesolv is a novel aqueous formulation containing dissolved budesonide showing increased local availability in preclinical models. Budesolv contains ~85% less corticosteroid than the marketed comparator.
OBJECTIVE


The study (EudraCT:2018-001324-19) was designed to assess non-inferiority of Budesolv compared to Rhinocort® Aqua 64 (RA) and early onset of action.
METHODS


In a three-way cross-over double-blinded randomized trial, Budesolv 10 was compared to RA and placebo in grass pollen allergic rhinoconjunctivitis volunteers (n = 83 (ITT); n = 75 (PP)). On day 1, participants entered the Vienna Challenge Chamber (VCC) for 6 hours; first treatment took place at 1:45 hours after entry. Participants treated themselves for further 6 days; on day 8, the last treatment was applied before entering the VCC. Subjective symptom scores, nasal airflow and nasal secretion were measured regularly during allergen challenge.
RESULTS


Budesolv 10 was equally effective compared to RA with respect to TNSS and nasal airflow after eight days of treatment with a strongly reduced dose (more than 80% reduction). After first dose, only Budesolv 10 showed a significant reduction of nasal and respiratory symptoms starting 90 minutes (P < .05) and 15 minutes (P < .05) after application onwards, respectively, demonstrating an early onset of efficacy. A clinically significant 1 point reduction in nasal symptom score was reached at 195 minutes (P < .05) after application.
CONCLUSIONS AND CLINICAL RELEVANCE


The novel preservative-free, aqueous low-dose budesonide formulation is highly efficacious even after an initial single treatment. Thus, Budesolv 10 appears to be an effective acute treatment for allergic rhinitis as well as for AR comorbidities like mild asthma and conjunctivitis.",2020,"A clinically significant 1 point reduction in nasal symptom score was reached at 195 minutes (p<0.05) after application.
","['allergic rhinitis', 'grass pollen allergic rhinoconjunctivitis volunteers (n=83 (ITT); n=75 (PP']","['Budesonide', 'RA and placebo', 'solubilized low-dose budesonide nasal spray']","['TNSS and nasal airflow', 'Subjective symptom scores, nasal airflow and nasal secretion', 'nasal symptom score', 'nasal and respiratory symptoms']","[{'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}, {'cui': 'C0440307', 'cui_str': 'grass pollen'}, {'cui': 'C0861154', 'cui_str': 'Allergic rhinoconjunctivitis'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C0678163', 'cui_str': 'Rhinocort'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C1245189', 'cui_str': 'Budesonide Nasal Spray'}]","[{'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0231999', 'cui_str': 'Airflow'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0231918', 'cui_str': 'Nose symptoms'}, {'cui': 'C0037090', 'cui_str': 'Respiratory symptom'}]",,0.0434773,"A clinically significant 1 point reduction in nasal symptom score was reached at 195 minutes (p<0.05) after application.
","[{'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Zieglmayer', 'Affiliation': 'Power Project GmbH, Vienna Challenge Chamber, Vienna, Austria.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Schmutz', 'Affiliation': 'Power Project GmbH, Vienna Challenge Chamber, Vienna, Austria.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Lemell', 'Affiliation': 'Power Project GmbH, Vienna Challenge Chamber, Vienna, Austria.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Unger-Manhart', 'Affiliation': 'Marinomed Biotech AG, Vienna, Austria.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Nakowitsch', 'Affiliation': 'Marinomed Biotech AG, Vienna, Austria.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Goessl', 'Affiliation': 'Marinomed Biotech AG, Vienna, Austria.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Savli', 'Affiliation': 'Biostatistik & Consulting, Hartberg, Austria.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Zieglmayer', 'Affiliation': 'Power Project GmbH, Vienna Challenge Chamber, Vienna, Austria.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Prieschl-Grassauer', 'Affiliation': 'Marinomed Biotech AG, Vienna, Austria.'}]",Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology,['10.1111/cea.13691']
1140,32578689,How to prevent the malignant progression of bipolar disorder.,"There is increasing recognition that, in a high percentage of cases, bipolar disorder is a progressive illness. Multiple types of sensitization (or increased reactivity to repetition of the same stimulus) drive illness progression. One of the clearest is that of episode sensitization, where increased numbers of prior episodes are associated with: faster recurrences; more dysfunction; disability; social, educational, and employment deficits; suicide; medical comorbidities; cognitive dysfunction; and an increased incidence of dementia in old age. Repetition of stressors and bouts of substance abuse can also result in sensitization. Each type of sensitization appears to have an epigenetic basis, such that preventing sensitization should minimize the accumulation of adverse epigenetic chemical marks on DNA, histones, and microRNA. New data emphasize the importance of early, consistent intervention after an initial manic episode. The cognitive dysfunction associated with a first episode improves only if there are no further episode recurrences during the next year. A randomized study has also shown that comprehensive multimodal prophylactic intervention for 2 years leads to improvements in illness course extending over a total of 6 years. Intensive treatment of the earliest stages of bipolar disorder can thus exert lasting positive effects on the course of illness.",2020,"One of the clearest is that of episode sensitization, where increased numbers of prior episodes are associated with: faster recurrences; more dysfunction; disability; social, educational, and employment deficits; suicide; medical comorbidities; cognitive dysfunction; and an increased incidence of dementia in old age.",[],['comprehensive multimodal prophylactic intervention'],['episode recurrences'],[],"[{'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]",,0.0219758,"One of the clearest is that of episode sensitization, where increased numbers of prior episodes are associated with: faster recurrences; more dysfunction; disability; social, educational, and employment deficits; suicide; medical comorbidities; cognitive dysfunction; and an increased incidence of dementia in old age.","[{'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Post', 'Affiliation': 'Bipolar Collaborative Network, School of Medicine, George Washington University, Washington, USA.'}]","Revista brasileira de psiquiatria (Sao Paulo, Brazil : 1999)",['10.1590/1516-4446-2020-0874']
1141,32446864,"Treatment of High-grade Non-muscle-invasive Bladder Carcinoma by Standard Number and Dose of BCG Instillations Versus Reduced Number and Standard Dose of BCG Instillations: Results of the European Association of Urology Research Foundation Randomised Phase III Clinical Trial ""NIMBUS"".","BACKGROUND


Intravesical instillation of bacillus Calmette-Guérin (BCG) is an accepted strategy to prevent recurrence of non-muscle-invasive bladder cancer (NMIBC) but associated with significant toxicity.
OBJECTIVE


NIMBUS assessed whether a reduced number of standard-dose BCG instillations are noninferior to the standard number and dose in patients with high-grade NMIBC.
DESIGN, SETTING, AND PARTICIPANTS


A total of 345 patients from 51 sites were randomised between December 2013 and July 2019. We report results after a data review and safety analysis by the Independent Data Monitoring Committee based on the cut-off date of July 1, 2019.
INTERVENTION


The standard BCG schedule was 6 wk of induction followed by 3 wk of maintenance at 3, 6, and 12 mo (15 instillations). The reduced frequency BCG schedule was induction at wks 1, 2, and 6 followed by 2 wk (wks 1 and 3) of maintenance at 3, 6, and 12 mo (nine instillations).
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS


The primary endpoint was time to first recurrence. Secondary endpoints included progression to ≥ T2 and toxicity.
RESULTS AND LIMITATIONS


In total, 170 patients were randomised to reduced frequency and 175 to standard BCG. Prognostic factors at initial resection were as follows: Ta/T1: 46/54%; primary/recurrent: 92/8%; single/multiple: 57/43%; and concomitant carcinoma in situ: 27%. After 12 mo of median follow-up, the intention-to-treat analysis showed a safety-relevant difference in recurrences between treatment arms: 46/170 (reduced frequency) versus 21/175 patients (standard). Additional safety analyses showed a hazard ratio of 0.40 with the upper part of the one-sided 97.5% confidence interval of 0.68, meeting a predefined stopping criterion for inferiority.
CONCLUSIONS


The reduced frequency schedule was inferior to the standard schedule regarding the time to first recurrence. Further recruitment of patients was stopped immediately to avoid harm in the reduced frequency BCG arm.
PATIENT SUMMARY


After surgical removal of the tumour, patients with high-grade non-muscle-invasive bladder cancer are treated with bacillus Calmette-Guérin to prevent recurrence and progression. This is associated with significant side effects. We report the results of a clinical trial showing a reduction in the number of instillations (from 15 to nine in total) being inferior to the standard protocol. From today's perspective, complete tumour resection and a standard number of instillations remain the standard of care.",2020,The reduced frequency schedule was inferior to the standard schedule regarding the time to first recurrence.,"['170 patients were randomised to reduced frequency and 175 to standard BCG', '345 patients from 51 sites were randomised between December 2013 and July 2019', 'patients with high-grade NMIBC', 'patients with high-grade non-muscle-invasive bladder cancer']","['bacillus Calmette-Guérin (BCG', 'BCG Instillations']","['progression to\u2009≥\u2009T2 and toxicity', 'safety-relevant difference in recurrences', 'time to first recurrence']","[{'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0004587', 'cui_str': 'Bacillus'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1827293', 'cui_str': 'Carcinoma of urinary bladder, invasive'}]","[{'cui': 'C0004587', 'cui_str': 'Bacillus'}, {'cui': 'C0184959', 'cui_str': 'Instillation'}]","[{'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",170.0,0.173047,The reduced frequency schedule was inferior to the standard schedule regarding the time to first recurrence.,"[{'ForeName': 'Marc-Oliver', 'Initials': 'MO', 'LastName': 'Grimm', 'Affiliation': 'Department of Urology, Jena University Hospital, Jena, Germany. Electronic address: marc-oliver.grimm@med.uni-jena.de.'}, {'ForeName': 'Antoine G', 'Initials': 'AG', 'LastName': 'van der Heijden', 'Affiliation': 'Department of Urology, Radboud UMC, Nijmegen, The Netherlands.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Colombel', 'Affiliation': 'Department of Urology, Hospital Edouard Herriot, Lyon, France.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Muilwijk', 'Affiliation': 'Department of Urology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Martínez-Piñeiro', 'Affiliation': 'Department of Urology, Hospital Universitario La Paz, Madrid, Spain.'}, {'ForeName': 'Marko M', 'Initials': 'MM', 'LastName': 'Babjuk', 'Affiliation': 'Department of Urology, Hospital Motol, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Levent N', 'Initials': 'LN', 'LastName': 'Türkeri', 'Affiliation': 'Department of Urology, Acıbadem University, Istanbul, Turkey.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Palou', 'Affiliation': 'Urology Department, Fundació Puigvert, Barcelona, Spain.'}, {'ForeName': 'Anup', 'Initials': 'A', 'LastName': 'Patel', 'Affiliation': 'London, UK.'}, {'ForeName': 'Anders S', 'Initials': 'AS', 'LastName': 'Bjartell', 'Affiliation': 'EAU Research Foundation, Arnhem, The Netherlands; Skåne University Hospital, Lund University, Sweden.'}, {'ForeName': 'Christien', 'Initials': 'C', 'LastName': 'Caris', 'Affiliation': 'EAU Research Foundation, Arnhem, The Netherlands.'}, {'ForeName': 'Raymond G', 'Initials': 'RG', 'LastName': 'Schipper', 'Affiliation': 'EAU Research Foundation, Arnhem, The Netherlands.'}, {'ForeName': 'Wim P J', 'Initials': 'WPJ', 'LastName': 'Witjes', 'Affiliation': 'EAU Research Foundation, Arnhem, The Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European urology,['10.1016/j.eururo.2020.04.066']
1142,32448677,"Auditory versus visual neuroscience-informed cognitive training in schizophrenia: Effects on cognition, symptoms and quality of life.","BACKGROUND


Cognitive impairments are related to deficits in primary auditory and visual sensory processes in schizophrenia. These impairments can be remediated by neuroscience-informed computerized cognitive trainings that target auditory and visual processes. However, it is not clear which modality results in greater improvements in cognition, symptoms and quality of life. We aimed to investigate the impact of training auditory versus visual cognitive processes in global cognition in patients with schizophrenia.
METHODS


Seventy-nine schizophrenia participants were randomly assigned to either 40 h of auditory or visual computerized training. Auditory and visual exercises were chosen to be dynamically equivalent and difficulties increased progressively during the training. We evaluated cognition, symptoms and quality of life before, after 20 h, and after 40 h of training. ClinicalTrials.gov (1R03TW009002-01).
RESULTS


Participants who received the visual training showed significant improvements in global cognition compared to the auditory training group. The visual training significantly improved attention and reasoning and problem-solving, while the auditory training improved reasoning and problem-solving only. Schizophrenia symptoms improved after training in both groups, whereas quality of life remained unchanged. Interestingly, there was a significant and positive correlation between improvements in attention and symptoms in the visual training group.
CONCLUSIONS


We conclude that the visual training and the auditory training are differentially efficient at remediating cognitive deficits and symptoms of clinically stable schizophrenia patients. Ongoing follow-up of participants will evaluate the durability of training effects on cognition and symptoms, as well as the potential impact on quality of life over time.",2020,"The visual training significantly improved attention and reasoning and problem-solving, while the auditory training improved reasoning and problem-solving only.","['patients with schizophrenia', 'clinically stable schizophrenia patients', 'schizophrenia', 'Seventy-nine schizophrenia participants']","['visual training and the auditory training', 'Auditory and visual exercises', 'visual training', 'Auditory versus visual neuroscience-informed cognitive training', 'training auditory versus visual cognitive processes', '40\xa0h of auditory or visual computerized training']","['quality of life', 'global cognition', 'Schizophrenia symptoms', 'attention and symptoms', 'attention and reasoning and problem-solving', 'cognition, symptoms and quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C3816957', 'cui_str': '70'}]","[{'cui': 'C0200244', 'cui_str': 'Visual training'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0027910', 'cui_str': 'Neurosciences'}, {'cui': 'C0700287', 'cui_str': 'Informing'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0025361', 'cui_str': 'Form of thinking'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0684328', 'cui_str': 'Reasoning'}, {'cui': 'C0033211', 'cui_str': 'Problem solving'}]",79.0,0.0306674,"The visual training significantly improved attention and reasoning and problem-solving, while the auditory training improved reasoning and problem-solving only.","[{'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Scoriels', 'Affiliation': 'Instituto de Ciencias Biomedicas, Universidade Federal do Rio de Janeiro, Brazil; Instituto de Psiquiatria, Universidade Federal do Rio de Janeiro, Brazil; Department of Psychiatry, University of Cambridge, United Kingdom.'}, {'ForeName': 'Larissa T', 'Initials': 'LT', 'LastName': 'Genaro', 'Affiliation': 'Instituto de Ciencias Biomedicas, Universidade Federal do Rio de Janeiro, Brazil; Instituto de Psiquiatria, Universidade Federal do Rio de Janeiro, Brazil.'}, {'ForeName': 'Luana G C', 'Initials': 'LGC', 'LastName': 'Mororó', 'Affiliation': 'Instituto de Ciencias Biomedicas, Universidade Federal do Rio de Janeiro, Brazil; Instituto de Psiquiatria, Universidade Federal do Rio de Janeiro, Brazil.'}, {'ForeName': 'Stella', 'Initials': 'S', 'LastName': 'Keffer', 'Affiliation': 'Instituto de Ciencias Biomedicas, Universidade Federal do Rio de Janeiro, Brazil; Instituto de Psiquiatria, Universidade Federal do Rio de Janeiro, Brazil.'}, {'ForeName': 'Anna Luiza D V', 'Initials': 'ALDV', 'LastName': 'Guimarães', 'Affiliation': 'Instituto de Ciencias Biomedicas, Universidade Federal do Rio de Janeiro, Brazil; Instituto de Psiquiatria, Universidade Federal do Rio de Janeiro, Brazil.'}, {'ForeName': 'Paulo V S', 'Initials': 'PVS', 'LastName': 'Ribeiro', 'Affiliation': 'Instituto de Ciencias Biomedicas, Universidade Federal do Rio de Janeiro, Brazil; Instituto de Psiquiatria, Universidade Federal do Rio de Janeiro, Brazil.'}, {'ForeName': 'Filippe M', 'Initials': 'FM', 'LastName': 'Tannos', 'Affiliation': 'Instituto de Ciencias Biomedicas, Universidade Federal do Rio de Janeiro, Brazil; Instituto de Psiquiatria, Universidade Federal do Rio de Janeiro, Brazil.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Novaes', 'Affiliation': 'Instituto de Ciencias Biomedicas, Universidade Federal do Rio de Janeiro, Brazil; Instituto de Psiquiatria, Universidade Federal do Rio de Janeiro, Brazil.'}, {'ForeName': 'Aniela I', 'Initials': 'AI', 'LastName': 'França', 'Affiliation': 'Faculdade de Letras, Universidade Federal do Rio de Janeiro, Brazil.'}, {'ForeName': 'Nelson', 'Initials': 'N', 'LastName': 'Goldenstein', 'Affiliation': 'Instituto de Psiquiatria, Universidade Federal do Rio de Janeiro, Brazil.'}, {'ForeName': 'Barbara J', 'Initials': 'BJ', 'LastName': 'Sahakian', 'Affiliation': 'Department of Psychiatry, University of Cambridge, United Kingdom.'}, {'ForeName': 'Maria T', 'Initials': 'MT', 'LastName': 'Cavalcanti', 'Affiliation': 'Instituto de Psiquiatria, Universidade Federal do Rio de Janeiro, Brazil.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Fisher', 'Affiliation': 'Department of Psychiatry, University of Minnesota, United States.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Vinogradov', 'Affiliation': 'Department of Psychiatry, University of Minnesota, United States.'}, {'ForeName': 'Rogerio', 'Initials': 'R', 'LastName': 'Panizzutti', 'Affiliation': 'Instituto de Ciencias Biomedicas, Universidade Federal do Rio de Janeiro, Brazil; Instituto de Psiquiatria, Universidade Federal do Rio de Janeiro, Brazil. Electronic address: rogerio@icb.ufrj.br.'}]",Schizophrenia research,['10.1016/j.schres.2020.05.017']
1143,32448711,Video Education to Improve Preoperative Anxiety in the Bariatric Surgical Patient: A Quality Improvement Project.,"PURPOSE


Evidence supports that providing preoperative education using an audiovisual format is an effective method to reduce anxiety in the surgical patient. The purpose of this quality improvement project was to evaluate the effect of viewing a video tour of the perioperative division had on patient-perceived preoperative anxiety.
DESIGN


A quasi-experimental design using a pre-post survey method of two individual groups.
METHODS


Sixty bariatric surgery patients completed a visual analog scale for anxiety (VAS-A), consisting of 10 items, on arrival and at the end of their preassessment appointment. Thirty patients in the comparison group received preoperative education with the current process of written and verbal instructions. Thirty patients in the intervention group received education with written and verbal instructions as well as inclusion of an informational video tour of the perioperative division. A paired sample t test was used to compare VAS-A results of the comparison and intervention groups.
FINDINGS


Data supported that bariatric patients who received only verbal and written instructions preoperatively had a statistically significant reduction in anxiety levels in five of 10 items on the VAS-A. Bariatric patients who received education with verbal and written instructions, as well as inclusion of the informational video tour, had a statistically significant reduction in self-perceived anxiety in 9 of 10 items on the VAS-A.
CONCLUSIONS


Data supported that the addition of an audiovisual component in the form of an informational tour of the perioperative division is an effective method to reduce perceived preoperative anxiety in patients having bariatric surgery.",2020,"FINDINGS


Data supported that bariatric patients who received only verbal and written instructions preoperatively had a statistically significant reduction in anxiety levels in five of 10 items on the VAS-A. Bariatric patients who received education with verbal and written instructions, as well as inclusion of the informational video tour, had a statistically significant reduction in self-perceived anxiety in 9 of 10 items on the VAS-A.
CONCLUSIONS


Data supported that the addition of an audiovisual component in the form of an informational tour of the perioperative division is an effective method to reduce perceived preoperative anxiety in patients having bariatric surgery.","['Thirty patients in the intervention group received', 'patients having bariatric surgery', 'Bariatric Surgical Patient', 'Sixty bariatric surgery patients completed a visual analog scale for anxiety (VAS-A), consisting of 10 items, on arrival and at the end of their preassessment appointment']","['Video Education', 'education with written and verbal instructions as well as inclusion of an informational video tour of the perioperative division', 'preoperative education with the current process of written and verbal instructions']","['anxiety levels', 'preoperative anxiety', 'self-perceived anxiety', 'Preoperative Anxiety']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C1450026', 'cui_str': 'Bariatrics'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C1293097', 'cui_str': 'Division'}, {'cui': 'C0204956', 'cui_str': 'Preoperative education'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C1522240', 'cui_str': 'Process'}]","[{'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",60.0,0.0276817,"FINDINGS


Data supported that bariatric patients who received only verbal and written instructions preoperatively had a statistically significant reduction in anxiety levels in five of 10 items on the VAS-A. Bariatric patients who received education with verbal and written instructions, as well as inclusion of the informational video tour, had a statistically significant reduction in self-perceived anxiety in 9 of 10 items on the VAS-A.
CONCLUSIONS


Data supported that the addition of an audiovisual component in the form of an informational tour of the perioperative division is an effective method to reduce perceived preoperative anxiety in patients having bariatric surgery.","[{'ForeName': 'Lori J', 'Initials': 'LJ', 'LastName': 'Helms', 'Affiliation': 'Perioperative Services, Reading Hospital/Tower Health, West Reading, PA. Electronic address: lori.helms@towerhealth.org.'}]",Journal of perianesthesia nursing : official journal of the American Society of PeriAnesthesia Nurses,['10.1016/j.jopan.2020.01.012']
1144,32453369,Effect of Doxycycline on Aneurysm Growth Among Patients With Small Infrarenal Abdominal Aortic Aneurysms: A Randomized Clinical Trial.,"Importance


Abdominal aortic aneurysms affect more than 3% of US older adults.
Objective


To test whether doxycycline reduces the growth of abdominal aortic aneurysm over 2 years as measured by maximum transverse diameter.
Design, Setting, and Participants


Parallel, 2-group, randomized clinical trial that was conducted at 22 US clinical centers between May 2013 and January 2017, and enrolled patients 50 years or older with small (3.5-5.0 cm for men, 3.5-4.5 cm for women) infrarenal aneurysms. The final date of follow-up was July 31, 2018.
Interventions


Patients were randomized to receive twice daily for 2 years doxycycline 100 mg orally (as capsules) (n = 133) or placebo (n = 128).
Main Outcomes and Measures


The primary outcome was change in abdominal aortic aneurysm maximum transverse diameter measured from CT images at baseline and follow-up at 2 years. Patients were assigned ranks based on the maximum transverse diameter (measured or imputed) of the aorta and also if they underwent aneurysm repair or died. The ranks were converted to scores having a normal distribution to facilitate the primary analysis (""normal scores"").
Results


Of 261 patients randomized, no follow-up CT scans were obtained on 7 (3%), leaving a final analysis set of 129 patients assigned to doxycycline and 125 to placebo (mean [SD] age, 71.0 years [7.4 years], 35 women [14%]). The outcome normal scores used in the primary analysis were based on maximum transverse diameter (measured or imputed) in 113 patients (88%) in the doxycycline group and 112 patients (90%) in the placebo group; aneurysm repair in 13 (10%) and 9 (7%), and death in 3 (2%) and 4 (3%), respectively. The primary outcome, normal scores reflecting change in aortic diameter, did not differ significantly between the 2 groups, mean change in normal scores, 0.0262 vs -0.0258 (1-sided P = .71). Mean (SD) baseline maximum transverse diameter was 4.3 cm (0.4 cm) for doxycycline and 4.3 cm (0.4 cm) for placebo. At the 2-year follow-up, the change in measured maximum transverse diameter was 0.36 cm (95% CI, 0.31 to 0.40 cm) for 96 patients in the doxycycline group vs 0.36 cm (95% CI, 0.30 to 0.41 cm) for 101 patients in the placebo group (difference, 0.0; 95% CI, -0.07 to 0.07 cm; 2-sided P = .93). No patients were withdrawn from the study because of adverse effects. Joint pain occurred in 84 of 129 patients (65%) with doxycycline and 79 of 125 (63%) with placebo.
Conclusions and Relevance


Among patients with small infrarenal abdominal aortic aneurysms, doxycycline compared with placebo did not significantly reduce aneurysm growth at 2 years. These findings do not support the use of doxycycline for reducing the growth of small abdominal aortic aneurysms.
Trial Registration


ClinicalTrials.gov Identifier: NCT01756833.",2020,"To test whether doxycycline reduces the growth of abdominal aortic aneurysm over 2 years as measured by maximum transverse diameter.
","['22 US clinical centers between May 2013 and January 2017, and enrolled patients 50 years or older with small (3.5-5.0 cm for men, 3.5-4.5 cm for women) infrarenal aneurysms', 'Patients With Small Infrarenal Abdominal Aortic Aneurysms', 'patients with small infrarenal abdominal aortic aneurysms', '261 patients randomized']","['Doxycycline', 'doxycycline 100 mg orally (as capsules', 'doxycycline', 'placebo']","['Joint pain', 'maximum transverse diameter', 'growth of abdominal aortic aneurysm', 'death', 'mean change in normal scores', 'normal scores reflecting change in aortic diameter', 'change in abdominal aortic aneurysm maximum transverse diameter measured from CT images', 'Mean (SD) baseline maximum transverse diameter', 'aneurysm repair', 'aneurysm growth']","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C3844009', 'cui_str': '4.5'}, {'cui': 'C0002940', 'cui_str': 'Aneurysm'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0162871', 'cui_str': 'Abdominal aortic aneurysm'}]","[{'cui': 'C0013090', 'cui_str': 'Doxycycline'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0003862', 'cui_str': 'Joint pain'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0205106', 'cui_str': 'Transverse plane'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0162871', 'cui_str': 'Abdominal aortic aneurysm'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0558058', 'cui_str': 'Reflecting'}, {'cui': 'C0579133', 'cui_str': 'Aortic diameter'}, {'cui': 'C0449770', 'cui_str': 'Measured from'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0189661', 'cui_str': 'Repair of aneurysm'}, {'cui': 'C0002940', 'cui_str': 'Aneurysm'}]",261.0,0.567673,"To test whether doxycycline reduces the growth of abdominal aortic aneurysm over 2 years as measured by maximum transverse diameter.
","[{'ForeName': 'B Timothy', 'Initials': 'BT', 'LastName': 'Baxter', 'Affiliation': 'Department of Surgery, University of Nebraska School of Medicine, Omaha.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Matsumura', 'Affiliation': 'Department of Surgery, University of Wisconsin School of Medicine and Public Health, Madison.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Curci', 'Affiliation': 'Department of Surgery, Vanderbilt University School of Medicine, Nashville, Tennessee.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'McBride', 'Affiliation': 'Axio Research, LLC, Seattle, Washington.'}, {'ForeName': 'LuAnn', 'Initials': 'L', 'LastName': 'Larson', 'Affiliation': 'Department of Surgery, University of Nebraska School of Medicine, Omaha.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Blackwelder', 'Affiliation': 'Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Lam', 'Affiliation': 'Genentech, Oakland, California.'}, {'ForeName': 'Marniker', 'Initials': 'M', 'LastName': 'Wijesinha', 'Affiliation': 'Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Terrin', 'Affiliation': 'Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2020.5230']
1145,32450273,Effect of postural training using a whole-body tilt apparatus in subacute stroke patients with lateropulsion: A single-blinded randomized controlled trial.,"BACKGROUND


Lateropulsion after stroke is defined as a postural bias toward the paretic side and push away from the non-paretic side. New rehabilitation techniques and programs should be designed to attenuate lateropulsion and improve functions of balance and gait.
OBJECTIVE


This study aimed to determine the effects of whole-body tilting postural training (WTPT) using a Spine Balance 3D on lateropulsion and postural control as compared with general postural training (GPT). Postural training was performed and involved a whole-body tilt apparatus that enables postural training in the tilted position, in multiple directions.
METHODS


This was a pragmatic, single-blind, randomized controlled trial conducted between June 2018 and May 2019. We randomly allocated 30 patients with subacute stroke and lateropulsion based on the Scale of Contraversive Pushing (SCP score>0) to experimental (n=15) and control (n=15) groups. The experimental group received WTPT with a whole-body tilt apparatus, and the control group GPT. WTPT was performed with the Spine Balance 3D and GPT with postural training commonly applied in the clinic. All participants received treatment for 30min/session, 2 times/day, 5 days/week for 3 weeks. The primary outcome measure was lateropulsion assessed with the Burke Lateropulsion Scale (BLS). Secondary outcome measures were postural control ability, activities of daily living, Postural Assessment Scale for Stroke (PASS) score, Berg Balance Scale (BBS) score, Korea-modified Barthel index (K-MBI), and Fugl-Meyer Motor Assessment-Lower Extremity (FMA-L) score.
RESULTS


For the primary outcome, after training, BLS scores were decreased more for the experimental than control group (Δ=-5.8 vs. Δ=-4.2, P=0.002). For secondary outcomes, scores were improved more for the experimental than control group: PASS (Δ=13.8 vs. Δ=8.5, P<0.001), BBS (Δ=20.1 vs. Δ=11.1, P=0.001), K-MBI (Δ=27.0 vs. Δ=20.1, P=0.005), and FMA-L (Δ=10.2 vs. Δ=6.3, P=0.002).
CONCLUSIONS


WTPT is a potentially effective therapeutic intervention for lateropulsion recovery in patients with subacute stroke. It may be useful for improving postural control and activities of daily living.",2020,"For secondary outcomes, scores were improved more for the experimental than control group: PASS (Δ = 13.8 vs Δ = 8.5, P <0.001), BBS (Δ = 20.1 vs Δ = 11.1, P=0.001), K-MBI (Δ = 27.0 vs Δ = 20.1, P = 0.005), and FMA-L (Δ = 10.2 vs Δ = 6.3, P = 0.002).
","['patients with subacute stroke', 'June 2018 and May 2019', '30 patients with subacute stroke and lateropulsion based on the Scale of Contraversive Pushing (SCP score >0) to experimental (n=15) and control (n=15) groups', 'subacute stroke patients with lateropulsion']","['WTPT with a whole-body tilt apparatus, and the control group GPT', 'whole-body tilting postural training (WTPT', 'general postural training (GPT', 'WTPT', 'postural training', 'Postural training was performed and involved a whole-body tilt apparatus that enables postural training']","['postural control ability, activities of daily living, Postural Assessment Scale for Stroke (PASS) score, Berg Balance Scale (BBS) score, Korea-modified Barthel index (K-MBI), and Fugl-Meyer Motor Assessment-Lower Extremity (FMA-L) score', 'lateropulsion assessed with the Burke Lateropulsion Scale (BLS', 'BBS', 'BLS scores', 'K-MBI', 'postural control and activities of daily living']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205365', 'cui_str': 'Subacute'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C4728026', 'cui_str': 'Lateropulsion'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1145610', 'cui_str': 'sodium cellulose phosphate'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0243111', 'cui_str': 'apparatus'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0562342', 'cui_str': 'Empowered'}]","[{'cui': 'C4760618', 'cui_str': 'Posture Control'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0022771', 'cui_str': 'Korea'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C4728026', 'cui_str': 'Lateropulsion'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",30.0,0.0509118,"For secondary outcomes, scores were improved more for the experimental than control group: PASS (Δ = 13.8 vs Δ = 8.5, P <0.001), BBS (Δ = 20.1 vs Δ = 11.1, P=0.001), K-MBI (Δ = 27.0 vs Δ = 20.1, P = 0.005), and FMA-L (Δ = 10.2 vs Δ = 6.3, P = 0.002).
","[{'ForeName': 'Chang-Man', 'Initials': 'CM', 'LastName': 'An', 'Affiliation': 'Department of Physical Medicine & Rehabilitation, Jeonbuk National University Medical School, 20, Geonjiro, Deokjin-gu, Jeonju, Jeonbuk, 54907, Republic of Korea.'}, {'ForeName': 'Myoung-Hwan', 'Initials': 'MH', 'LastName': 'Ko', 'Affiliation': 'Department of Physical Medicine & Rehabilitation, Jeonbuk National University Medical School, 20, Geonjiro, Deokjin-gu, Jeonju, Jeonbuk, 54907, Republic of Korea; Research Institute of Clinical Medicine of Jeonbuk National University - Biomedical Research Institute of Jeonbuk National University Hospital, Jeonju, 54907, Republic of Korea; Translational Research & Clinical Trial Center for Medical Device, Jeonbuk National University Hospital, Jeonju, 54907, Republic of Korea.'}, {'ForeName': 'Dae-Hyun', 'Initials': 'DH', 'LastName': 'Kim', 'Affiliation': 'Department of Physical Medicine & Rehabilitation, Jeonbuk National University Medical School, 20, Geonjiro, Deokjin-gu, Jeonju, Jeonbuk, 54907, Republic of Korea.'}, {'ForeName': 'Gi-Wook', 'Initials': 'GW', 'LastName': 'Kim', 'Affiliation': 'Department of Physical Medicine & Rehabilitation, Jeonbuk National University Medical School, 20, Geonjiro, Deokjin-gu, Jeonju, Jeonbuk, 54907, Republic of Korea; Research Institute of Clinical Medicine of Jeonbuk National University - Biomedical Research Institute of Jeonbuk National University Hospital, Jeonju, 54907, Republic of Korea; Translational Research & Clinical Trial Center for Medical Device, Jeonbuk National University Hospital, Jeonju, 54907, Republic of Korea. Electronic address: k26@jbnu.ac.kr.'}]",Annals of physical and rehabilitation medicine,['10.1016/j.rehab.2020.05.001']
1146,32579811,Effects of Allopurinol on the Progression of Chronic Kidney Disease.,"BACKGROUND


Elevated serum urate levels are associated with progression of chronic kidney disease. Whether urate-lowering treatment with allopurinol can attenuate the decline of the estimated glomerular filtration rate (eGFR) in patients with chronic kidney disease who are at risk for progression is not known.
METHODS


In this randomized, controlled trial, we randomly assigned adults with stage 3 or 4 chronic kidney disease and no history of gout who had a urinary albumin:creatinine ratio of 265 or higher (with albumin measured in milligrams and creatinine in grams) or an eGFR decrease of at least 3.0 ml per minute per 1.73 m 2  of body-surface area in the preceding year to receive allopurinol (100 to 300 mg daily) or placebo. The primary outcome was the change in eGFR from randomization to week 104, calculated with the Chronic Kidney Disease Epidemiology Collaboration creatinine equation.
RESULTS


Enrollment was stopped because of slow recruitment after 369 of 620 intended patients were randomly assigned to receive allopurinol (185 patients) or placebo (184 patients). Three patients per group withdrew immediately after randomization. The remaining 363 patients (mean eGFR, 31.7 ml per minute per 1.73 m 2 ; median urine albumin:creatinine ratio, 716.9; mean serum urate level, 8.2 mg per deciliter) were included in the assessment of the primary outcome. The change in eGFR did not differ significantly between the allopurinol group and the placebo group (-3.33 ml per minute per 1.73 m 2  per year [95% confidence interval {CI}, -4.11 to -2.55] and -3.23 ml per minute per 1.73 m 2  per year [95% CI, -3.98 to -2.47], respectively; mean difference, -0.10 ml per minute per 1.73 m 2  per year [95% CI, -1.18 to 0.97]; P = 0.85). Serious adverse events were reported in 84 of 182 patients (46%) in the allopurinol group and in 79 of 181 patients (44%) in the placebo group.
CONCLUSIONS


In patients with chronic kidney disease and a high risk of progression, urate-lowering treatment with allopurinol did not slow the decline in eGFR as compared with placebo. (Funded by the National Health and Medical Research Council of Australia and the Health Research Council of New Zealand; CKD-FIX Australian New Zealand Clinical Trials Registry number, ACTRN12611000791932.).",2020,"The change in eGFR did not differ significantly between the allopurinol group and the placebo group (-3.33 ml per minute per 1.73 m 2  per year [95% confidence interval {CI}, -4.11 to -2.55] and","['patients with chronic kidney disease who are at risk for progression is not known', 'patients with chronic kidney disease and a high risk of progression, urate-lowering treatment with', 'The remaining 363 patients (mean eGFR, 31.7 ml per minute per 1.73 m 2 ; median urine albumin:creatinine ratio, 716.9; mean serum urate level, 8.2 mg per deciliter', 'Enrollment was stopped because of slow recruitment after 369 of 620 intended patients', 'randomly assigned adults with stage 3 or 4 chronic kidney disease and no history of gout who had a urinary albumin:creatinine ratio of 265 or higher (with albumin measured in milligrams and creatinine in grams) or an eGFR decrease of at least 3.0 ml per minute per 1.73 m 2  of body-surface area in the preceding year to receive']","['placebo', 'allopurinol', 'Allopurinol']","['Chronic Kidney Disease Epidemiology Collaboration creatinine equation', 'glomerular filtration rate (eGFR', 'change in eGFR', 'Progression of Chronic Kidney Disease', 'Serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0439673', 'cui_str': 'Unknown'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0202239', 'cui_str': 'Uric acid measurement'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C4708784', 'cui_str': '31.7'}, {'cui': 'C0702093', 'cui_str': '/minute'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0042038', 'cui_str': 'Albumin urine'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0455272', 'cui_str': 'Serum urate measurement'}, {'cui': 'C0439241', 'cui_str': 'dL'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C4708788', 'cui_str': '620'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0332122', 'cui_str': 'No history of'}, {'cui': 'C0018099', 'cui_str': 'Gout'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439210', 'cui_str': 'mg'}, {'cui': 'C0439208', 'cui_str': 'g'}, {'cui': 'C4552444', 'cui_str': 'Estimated glomerular filtration rate decreased'}, {'cui': 'C0005902', 'cui_str': 'Body surface area'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0002144', 'cui_str': 'Allopurinol'}]","[{'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0014507', 'cui_str': 'Epidemiology'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",620.0,0.744268,"The change in eGFR did not differ significantly between the allopurinol group and the placebo group (-3.33 ml per minute per 1.73 m 2  per year [95% confidence interval {CI}, -4.11 to -2.55] and","[{'ForeName': 'Sunil V', 'Initials': 'SV', 'LastName': 'Badve', 'Affiliation': ""From the Department of Renal Medicine, St. George Hospital (S.V.B., A.T.), the Renal and Metabolic Division, George Institute for Global Health (S.V.B., A.T., V.P.), and St. Vincent's Clinical School (R.O.D., G.R.D.J.), University of New South Wales Medicine, the Departments of Clinical Pharmacology and Toxicology (R.O.D.) and Chemical Pathology, SydPath (G.R.D.J.), St. Vincent's Hospital, the Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney (D.C.H., G.K.R.), the Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District (D.C.H., G.K.R.), and the Department of Nephrology, the Royal North Shore Hospital (V.P.), Sydney, the Australasian Kidney Trials Network, University of Queensland (S.V.B., E.M.P., N.B., C.M.H., D.R., L.R., D.W.J.), the Department of Nephrology, Princess Alexandra Hospital, (B.D., C.M.H., D.W.J.), and the Translational Research Institute (D.W.J.), Brisbane, QLD, the Medical School, University of Western Australia, Perth (N.B.), the Department of Nephrology, Monash University at Monash Medical Centre, Melbourne, VIC (F.G.B., J.K.), Menzies School of Health Research, Charles Darwin University, Darwin, NT (A.C.), the University of Adelaide and Central Northern Adelaide Renal and Transplantation Services, Adelaide, SA (R.F.), and the Australian National University Medical School and the Department of Nephrology, Canberra Hospital, Canberra, ACT (G.W.) - all in Australia; the Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (P.C.); and the Department of Medicine, University of Auckland (N.D., J.R.Z.), and the Renal Service, Waitemata District Health Board (J.R.Z.), Auckland, the Department of Medicine, University of Otago Christchurch, Christchurch (S.C.P.), and Dunedin School of Medicine, University of Otago, Dunedin (R.J.W.) - all in New Zealand.""}, {'ForeName': 'Elaine M', 'Initials': 'EM', 'LastName': 'Pascoe', 'Affiliation': ""From the Department of Renal Medicine, St. George Hospital (S.V.B., A.T.), the Renal and Metabolic Division, George Institute for Global Health (S.V.B., A.T., V.P.), and St. Vincent's Clinical School (R.O.D., G.R.D.J.), University of New South Wales Medicine, the Departments of Clinical Pharmacology and Toxicology (R.O.D.) and Chemical Pathology, SydPath (G.R.D.J.), St. Vincent's Hospital, the Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney (D.C.H., G.K.R.), the Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District (D.C.H., G.K.R.), and the Department of Nephrology, the Royal North Shore Hospital (V.P.), Sydney, the Australasian Kidney Trials Network, University of Queensland (S.V.B., E.M.P., N.B., C.M.H., D.R., L.R., D.W.J.), the Department of Nephrology, Princess Alexandra Hospital, (B.D., C.M.H., D.W.J.), and the Translational Research Institute (D.W.J.), Brisbane, QLD, the Medical School, University of Western Australia, Perth (N.B.), the Department of Nephrology, Monash University at Monash Medical Centre, Melbourne, VIC (F.G.B., J.K.), Menzies School of Health Research, Charles Darwin University, Darwin, NT (A.C.), the University of Adelaide and Central Northern Adelaide Renal and Transplantation Services, Adelaide, SA (R.F.), and the Australian National University Medical School and the Department of Nephrology, Canberra Hospital, Canberra, ACT (G.W.) - all in Australia; the Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (P.C.); and the Department of Medicine, University of Auckland (N.D., J.R.Z.), and the Renal Service, Waitemata District Health Board (J.R.Z.), Auckland, the Department of Medicine, University of Otago Christchurch, Christchurch (S.C.P.), and Dunedin School of Medicine, University of Otago, Dunedin (R.J.W.) - all in New Zealand.""}, {'ForeName': 'Anushree', 'Initials': 'A', 'LastName': 'Tiku', 'Affiliation': ""From the Department of Renal Medicine, St. George Hospital (S.V.B., A.T.), the Renal and Metabolic Division, George Institute for Global Health (S.V.B., A.T., V.P.), and St. Vincent's Clinical School (R.O.D., G.R.D.J.), University of New South Wales Medicine, the Departments of Clinical Pharmacology and Toxicology (R.O.D.) and Chemical Pathology, SydPath (G.R.D.J.), St. Vincent's Hospital, the Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney (D.C.H., G.K.R.), the Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District (D.C.H., G.K.R.), and the Department of Nephrology, the Royal North Shore Hospital (V.P.), Sydney, the Australasian Kidney Trials Network, University of Queensland (S.V.B., E.M.P., N.B., C.M.H., D.R., L.R., D.W.J.), the Department of Nephrology, Princess Alexandra Hospital, (B.D., C.M.H., D.W.J.), and the Translational Research Institute (D.W.J.), Brisbane, QLD, the Medical School, University of Western Australia, Perth (N.B.), the Department of Nephrology, Monash University at Monash Medical Centre, Melbourne, VIC (F.G.B., J.K.), Menzies School of Health Research, Charles Darwin University, Darwin, NT (A.C.), the University of Adelaide and Central Northern Adelaide Renal and Transplantation Services, Adelaide, SA (R.F.), and the Australian National University Medical School and the Department of Nephrology, Canberra Hospital, Canberra, ACT (G.W.) - all in Australia; the Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (P.C.); and the Department of Medicine, University of Auckland (N.D., J.R.Z.), and the Renal Service, Waitemata District Health Board (J.R.Z.), Auckland, the Department of Medicine, University of Otago Christchurch, Christchurch (S.C.P.), and Dunedin School of Medicine, University of Otago, Dunedin (R.J.W.) - all in New Zealand.""}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Boudville', 'Affiliation': ""From the Department of Renal Medicine, St. George Hospital (S.V.B., A.T.), the Renal and Metabolic Division, George Institute for Global Health (S.V.B., A.T., V.P.), and St. Vincent's Clinical School (R.O.D., G.R.D.J.), University of New South Wales Medicine, the Departments of Clinical Pharmacology and Toxicology (R.O.D.) and Chemical Pathology, SydPath (G.R.D.J.), St. Vincent's Hospital, the Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney (D.C.H., G.K.R.), the Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District (D.C.H., G.K.R.), and the Department of Nephrology, the Royal North Shore Hospital (V.P.), Sydney, the Australasian Kidney Trials Network, University of Queensland (S.V.B., E.M.P., N.B., C.M.H., D.R., L.R., D.W.J.), the Department of Nephrology, Princess Alexandra Hospital, (B.D., C.M.H., D.W.J.), and the Translational Research Institute (D.W.J.), Brisbane, QLD, the Medical School, University of Western Australia, Perth (N.B.), the Department of Nephrology, Monash University at Monash Medical Centre, Melbourne, VIC (F.G.B., J.K.), Menzies School of Health Research, Charles Darwin University, Darwin, NT (A.C.), the University of Adelaide and Central Northern Adelaide Renal and Transplantation Services, Adelaide, SA (R.F.), and the Australian National University Medical School and the Department of Nephrology, Canberra Hospital, Canberra, ACT (G.W.) - all in Australia; the Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (P.C.); and the Department of Medicine, University of Auckland (N.D., J.R.Z.), and the Renal Service, Waitemata District Health Board (J.R.Z.), Auckland, the Department of Medicine, University of Otago Christchurch, Christchurch (S.C.P.), and Dunedin School of Medicine, University of Otago, Dunedin (R.J.W.) - all in New Zealand.""}, {'ForeName': 'Fiona G', 'Initials': 'FG', 'LastName': 'Brown', 'Affiliation': ""From the Department of Renal Medicine, St. George Hospital (S.V.B., A.T.), the Renal and Metabolic Division, George Institute for Global Health (S.V.B., A.T., V.P.), and St. Vincent's Clinical School (R.O.D., G.R.D.J.), University of New South Wales Medicine, the Departments of Clinical Pharmacology and Toxicology (R.O.D.) and Chemical Pathology, SydPath (G.R.D.J.), St. Vincent's Hospital, the Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney (D.C.H., G.K.R.), the Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District (D.C.H., G.K.R.), and the Department of Nephrology, the Royal North Shore Hospital (V.P.), Sydney, the Australasian Kidney Trials Network, University of Queensland (S.V.B., E.M.P., N.B., C.M.H., D.R., L.R., D.W.J.), the Department of Nephrology, Princess Alexandra Hospital, (B.D., C.M.H., D.W.J.), and the Translational Research Institute (D.W.J.), Brisbane, QLD, the Medical School, University of Western Australia, Perth (N.B.), the Department of Nephrology, Monash University at Monash Medical Centre, Melbourne, VIC (F.G.B., J.K.), Menzies School of Health Research, Charles Darwin University, Darwin, NT (A.C.), the University of Adelaide and Central Northern Adelaide Renal and Transplantation Services, Adelaide, SA (R.F.), and the Australian National University Medical School and the Department of Nephrology, Canberra Hospital, Canberra, ACT (G.W.) - all in Australia; the Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (P.C.); and the Department of Medicine, University of Auckland (N.D., J.R.Z.), and the Renal Service, Waitemata District Health Board (J.R.Z.), Auckland, the Department of Medicine, University of Otago Christchurch, Christchurch (S.C.P.), and Dunedin School of Medicine, University of Otago, Dunedin (R.J.W.) - all in New Zealand.""}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Cass', 'Affiliation': ""From the Department of Renal Medicine, St. George Hospital (S.V.B., A.T.), the Renal and Metabolic Division, George Institute for Global Health (S.V.B., A.T., V.P.), and St. Vincent's Clinical School (R.O.D., G.R.D.J.), University of New South Wales Medicine, the Departments of Clinical Pharmacology and Toxicology (R.O.D.) and Chemical Pathology, SydPath (G.R.D.J.), St. Vincent's Hospital, the Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney (D.C.H., G.K.R.), the Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District (D.C.H., G.K.R.), and the Department of Nephrology, the Royal North Shore Hospital (V.P.), Sydney, the Australasian Kidney Trials Network, University of Queensland (S.V.B., E.M.P., N.B., C.M.H., D.R., L.R., D.W.J.), the Department of Nephrology, Princess Alexandra Hospital, (B.D., C.M.H., D.W.J.), and the Translational Research Institute (D.W.J.), Brisbane, QLD, the Medical School, University of Western Australia, Perth (N.B.), the Department of Nephrology, Monash University at Monash Medical Centre, Melbourne, VIC (F.G.B., J.K.), Menzies School of Health Research, Charles Darwin University, Darwin, NT (A.C.), the University of Adelaide and Central Northern Adelaide Renal and Transplantation Services, Adelaide, SA (R.F.), and the Australian National University Medical School and the Department of Nephrology, Canberra Hospital, Canberra, ACT (G.W.) - all in Australia; the Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (P.C.); and the Department of Medicine, University of Auckland (N.D., J.R.Z.), and the Renal Service, Waitemata District Health Board (J.R.Z.), Auckland, the Department of Medicine, University of Otago Christchurch, Christchurch (S.C.P.), and Dunedin School of Medicine, University of Otago, Dunedin (R.J.W.) - all in New Zealand.""}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Clarke', 'Affiliation': ""From the Department of Renal Medicine, St. George Hospital (S.V.B., A.T.), the Renal and Metabolic Division, George Institute for Global Health (S.V.B., A.T., V.P.), and St. Vincent's Clinical School (R.O.D., G.R.D.J.), University of New South Wales Medicine, the Departments of Clinical Pharmacology and Toxicology (R.O.D.) and Chemical Pathology, SydPath (G.R.D.J.), St. Vincent's Hospital, the Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney (D.C.H., G.K.R.), the Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District (D.C.H., G.K.R.), and the Department of Nephrology, the Royal North Shore Hospital (V.P.), Sydney, the Australasian Kidney Trials Network, University of Queensland (S.V.B., E.M.P., N.B., C.M.H., D.R., L.R., D.W.J.), the Department of Nephrology, Princess Alexandra Hospital, (B.D., C.M.H., D.W.J.), and the Translational Research Institute (D.W.J.), Brisbane, QLD, the Medical School, University of Western Australia, Perth (N.B.), the Department of Nephrology, Monash University at Monash Medical Centre, Melbourne, VIC (F.G.B., J.K.), Menzies School of Health Research, Charles Darwin University, Darwin, NT (A.C.), the University of Adelaide and Central Northern Adelaide Renal and Transplantation Services, Adelaide, SA (R.F.), and the Australian National University Medical School and the Department of Nephrology, Canberra Hospital, Canberra, ACT (G.W.) - all in Australia; the Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (P.C.); and the Department of Medicine, University of Auckland (N.D., J.R.Z.), and the Renal Service, Waitemata District Health Board (J.R.Z.), Auckland, the Department of Medicine, University of Otago Christchurch, Christchurch (S.C.P.), and Dunedin School of Medicine, University of Otago, Dunedin (R.J.W.) - all in New Zealand.""}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Dalbeth', 'Affiliation': ""From the Department of Renal Medicine, St. George Hospital (S.V.B., A.T.), the Renal and Metabolic Division, George Institute for Global Health (S.V.B., A.T., V.P.), and St. Vincent's Clinical School (R.O.D., G.R.D.J.), University of New South Wales Medicine, the Departments of Clinical Pharmacology and Toxicology (R.O.D.) and Chemical Pathology, SydPath (G.R.D.J.), St. Vincent's Hospital, the Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney (D.C.H., G.K.R.), the Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District (D.C.H., G.K.R.), and the Department of Nephrology, the Royal North Shore Hospital (V.P.), Sydney, the Australasian Kidney Trials Network, University of Queensland (S.V.B., E.M.P., N.B., C.M.H., D.R., L.R., D.W.J.), the Department of Nephrology, Princess Alexandra Hospital, (B.D., C.M.H., D.W.J.), and the Translational Research Institute (D.W.J.), Brisbane, QLD, the Medical School, University of Western Australia, Perth (N.B.), the Department of Nephrology, Monash University at Monash Medical Centre, Melbourne, VIC (F.G.B., J.K.), Menzies School of Health Research, Charles Darwin University, Darwin, NT (A.C.), the University of Adelaide and Central Northern Adelaide Renal and Transplantation Services, Adelaide, SA (R.F.), and the Australian National University Medical School and the Department of Nephrology, Canberra Hospital, Canberra, ACT (G.W.) - all in Australia; the Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (P.C.); and the Department of Medicine, University of Auckland (N.D., J.R.Z.), and the Renal Service, Waitemata District Health Board (J.R.Z.), Auckland, the Department of Medicine, University of Otago Christchurch, Christchurch (S.C.P.), and Dunedin School of Medicine, University of Otago, Dunedin (R.J.W.) - all in New Zealand.""}, {'ForeName': 'Richard O', 'Initials': 'RO', 'LastName': 'Day', 'Affiliation': ""From the Department of Renal Medicine, St. George Hospital (S.V.B., A.T.), the Renal and Metabolic Division, George Institute for Global Health (S.V.B., A.T., V.P.), and St. Vincent's Clinical School (R.O.D., G.R.D.J.), University of New South Wales Medicine, the Departments of Clinical Pharmacology and Toxicology (R.O.D.) and Chemical Pathology, SydPath (G.R.D.J.), St. Vincent's Hospital, the Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney (D.C.H., G.K.R.), the Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District (D.C.H., G.K.R.), and the Department of Nephrology, the Royal North Shore Hospital (V.P.), Sydney, the Australasian Kidney Trials Network, University of Queensland (S.V.B., E.M.P., N.B., C.M.H., D.R., L.R., D.W.J.), the Department of Nephrology, Princess Alexandra Hospital, (B.D., C.M.H., D.W.J.), and the Translational Research Institute (D.W.J.), Brisbane, QLD, the Medical School, University of Western Australia, Perth (N.B.), the Department of Nephrology, Monash University at Monash Medical Centre, Melbourne, VIC (F.G.B., J.K.), Menzies School of Health Research, Charles Darwin University, Darwin, NT (A.C.), the University of Adelaide and Central Northern Adelaide Renal and Transplantation Services, Adelaide, SA (R.F.), and the Australian National University Medical School and the Department of Nephrology, Canberra Hospital, Canberra, ACT (G.W.) - all in Australia; the Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (P.C.); and the Department of Medicine, University of Auckland (N.D., J.R.Z.), and the Renal Service, Waitemata District Health Board (J.R.Z.), Auckland, the Department of Medicine, University of Otago Christchurch, Christchurch (S.C.P.), and Dunedin School of Medicine, University of Otago, Dunedin (R.J.W.) - all in New Zealand.""}, {'ForeName': 'Janak R', 'Initials': 'JR', 'LastName': 'de Zoysa', 'Affiliation': ""From the Department of Renal Medicine, St. George Hospital (S.V.B., A.T.), the Renal and Metabolic Division, George Institute for Global Health (S.V.B., A.T., V.P.), and St. Vincent's Clinical School (R.O.D., G.R.D.J.), University of New South Wales Medicine, the Departments of Clinical Pharmacology and Toxicology (R.O.D.) and Chemical Pathology, SydPath (G.R.D.J.), St. Vincent's Hospital, the Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney (D.C.H., G.K.R.), the Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District (D.C.H., G.K.R.), and the Department of Nephrology, the Royal North Shore Hospital (V.P.), Sydney, the Australasian Kidney Trials Network, University of Queensland (S.V.B., E.M.P., N.B., C.M.H., D.R., L.R., D.W.J.), the Department of Nephrology, Princess Alexandra Hospital, (B.D., C.M.H., D.W.J.), and the Translational Research Institute (D.W.J.), Brisbane, QLD, the Medical School, University of Western Australia, Perth (N.B.), the Department of Nephrology, Monash University at Monash Medical Centre, Melbourne, VIC (F.G.B., J.K.), Menzies School of Health Research, Charles Darwin University, Darwin, NT (A.C.), the University of Adelaide and Central Northern Adelaide Renal and Transplantation Services, Adelaide, SA (R.F.), and the Australian National University Medical School and the Department of Nephrology, Canberra Hospital, Canberra, ACT (G.W.) - all in Australia; the Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (P.C.); and the Department of Medicine, University of Auckland (N.D., J.R.Z.), and the Renal Service, Waitemata District Health Board (J.R.Z.), Auckland, the Department of Medicine, University of Otago Christchurch, Christchurch (S.C.P.), and Dunedin School of Medicine, University of Otago, Dunedin (R.J.W.) - all in New Zealand.""}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Douglas', 'Affiliation': ""From the Department of Renal Medicine, St. George Hospital (S.V.B., A.T.), the Renal and Metabolic Division, George Institute for Global Health (S.V.B., A.T., V.P.), and St. Vincent's Clinical School (R.O.D., G.R.D.J.), University of New South Wales Medicine, the Departments of Clinical Pharmacology and Toxicology (R.O.D.) and Chemical Pathology, SydPath (G.R.D.J.), St. Vincent's Hospital, the Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney (D.C.H., G.K.R.), the Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District (D.C.H., G.K.R.), and the Department of Nephrology, the Royal North Shore Hospital (V.P.), Sydney, the Australasian Kidney Trials Network, University of Queensland (S.V.B., E.M.P., N.B., C.M.H., D.R., L.R., D.W.J.), the Department of Nephrology, Princess Alexandra Hospital, (B.D., C.M.H., D.W.J.), and the Translational Research Institute (D.W.J.), Brisbane, QLD, the Medical School, University of Western Australia, Perth (N.B.), the Department of Nephrology, Monash University at Monash Medical Centre, Melbourne, VIC (F.G.B., J.K.), Menzies School of Health Research, Charles Darwin University, Darwin, NT (A.C.), the University of Adelaide and Central Northern Adelaide Renal and Transplantation Services, Adelaide, SA (R.F.), and the Australian National University Medical School and the Department of Nephrology, Canberra Hospital, Canberra, ACT (G.W.) - all in Australia; the Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (P.C.); and the Department of Medicine, University of Auckland (N.D., J.R.Z.), and the Renal Service, Waitemata District Health Board (J.R.Z.), Auckland, the Department of Medicine, University of Otago Christchurch, Christchurch (S.C.P.), and Dunedin School of Medicine, University of Otago, Dunedin (R.J.W.) - all in New Zealand.""}, {'ForeName': 'Randall', 'Initials': 'R', 'LastName': 'Faull', 'Affiliation': ""From the Department of Renal Medicine, St. George Hospital (S.V.B., A.T.), the Renal and Metabolic Division, George Institute for Global Health (S.V.B., A.T., V.P.), and St. Vincent's Clinical School (R.O.D., G.R.D.J.), University of New South Wales Medicine, the Departments of Clinical Pharmacology and Toxicology (R.O.D.) and Chemical Pathology, SydPath (G.R.D.J.), St. Vincent's Hospital, the Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney (D.C.H., G.K.R.), the Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District (D.C.H., G.K.R.), and the Department of Nephrology, the Royal North Shore Hospital (V.P.), Sydney, the Australasian Kidney Trials Network, University of Queensland (S.V.B., E.M.P., N.B., C.M.H., D.R., L.R., D.W.J.), the Department of Nephrology, Princess Alexandra Hospital, (B.D., C.M.H., D.W.J.), and the Translational Research Institute (D.W.J.), Brisbane, QLD, the Medical School, University of Western Australia, Perth (N.B.), the Department of Nephrology, Monash University at Monash Medical Centre, Melbourne, VIC (F.G.B., J.K.), Menzies School of Health Research, Charles Darwin University, Darwin, NT (A.C.), the University of Adelaide and Central Northern Adelaide Renal and Transplantation Services, Adelaide, SA (R.F.), and the Australian National University Medical School and the Department of Nephrology, Canberra Hospital, Canberra, ACT (G.W.) - all in Australia; the Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (P.C.); and the Department of Medicine, University of Auckland (N.D., J.R.Z.), and the Renal Service, Waitemata District Health Board (J.R.Z.), Auckland, the Department of Medicine, University of Otago Christchurch, Christchurch (S.C.P.), and Dunedin School of Medicine, University of Otago, Dunedin (R.J.W.) - all in New Zealand.""}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Harris', 'Affiliation': ""From the Department of Renal Medicine, St. George Hospital (S.V.B., A.T.), the Renal and Metabolic Division, George Institute for Global Health (S.V.B., A.T., V.P.), and St. Vincent's Clinical School (R.O.D., G.R.D.J.), University of New South Wales Medicine, the Departments of Clinical Pharmacology and Toxicology (R.O.D.) and Chemical Pathology, SydPath (G.R.D.J.), St. Vincent's Hospital, the Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney (D.C.H., G.K.R.), the Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District (D.C.H., G.K.R.), and the Department of Nephrology, the Royal North Shore Hospital (V.P.), Sydney, the Australasian Kidney Trials Network, University of Queensland (S.V.B., E.M.P., N.B., C.M.H., D.R., L.R., D.W.J.), the Department of Nephrology, Princess Alexandra Hospital, (B.D., C.M.H., D.W.J.), and the Translational Research Institute (D.W.J.), Brisbane, QLD, the Medical School, University of Western Australia, Perth (N.B.), the Department of Nephrology, Monash University at Monash Medical Centre, Melbourne, VIC (F.G.B., J.K.), Menzies School of Health Research, Charles Darwin University, Darwin, NT (A.C.), the University of Adelaide and Central Northern Adelaide Renal and Transplantation Services, Adelaide, SA (R.F.), and the Australian National University Medical School and the Department of Nephrology, Canberra Hospital, Canberra, ACT (G.W.) - all in Australia; the Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (P.C.); and the Department of Medicine, University of Auckland (N.D., J.R.Z.), and the Renal Service, Waitemata District Health Board (J.R.Z.), Auckland, the Department of Medicine, University of Otago Christchurch, Christchurch (S.C.P.), and Dunedin School of Medicine, University of Otago, Dunedin (R.J.W.) - all in New Zealand.""}, {'ForeName': 'Carmel M', 'Initials': 'CM', 'LastName': 'Hawley', 'Affiliation': ""From the Department of Renal Medicine, St. George Hospital (S.V.B., A.T.), the Renal and Metabolic Division, George Institute for Global Health (S.V.B., A.T., V.P.), and St. Vincent's Clinical School (R.O.D., G.R.D.J.), University of New South Wales Medicine, the Departments of Clinical Pharmacology and Toxicology (R.O.D.) and Chemical Pathology, SydPath (G.R.D.J.), St. Vincent's Hospital, the Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney (D.C.H., G.K.R.), the Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District (D.C.H., G.K.R.), and the Department of Nephrology, the Royal North Shore Hospital (V.P.), Sydney, the Australasian Kidney Trials Network, University of Queensland (S.V.B., E.M.P., N.B., C.M.H., D.R., L.R., D.W.J.), the Department of Nephrology, Princess Alexandra Hospital, (B.D., C.M.H., D.W.J.), and the Translational Research Institute (D.W.J.), Brisbane, QLD, the Medical School, University of Western Australia, Perth (N.B.), the Department of Nephrology, Monash University at Monash Medical Centre, Melbourne, VIC (F.G.B., J.K.), Menzies School of Health Research, Charles Darwin University, Darwin, NT (A.C.), the University of Adelaide and Central Northern Adelaide Renal and Transplantation Services, Adelaide, SA (R.F.), and the Australian National University Medical School and the Department of Nephrology, Canberra Hospital, Canberra, ACT (G.W.) - all in Australia; the Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (P.C.); and the Department of Medicine, University of Auckland (N.D., J.R.Z.), and the Renal Service, Waitemata District Health Board (J.R.Z.), Auckland, the Department of Medicine, University of Otago Christchurch, Christchurch (S.C.P.), and Dunedin School of Medicine, University of Otago, Dunedin (R.J.W.) - all in New Zealand.""}, {'ForeName': 'Graham R D', 'Initials': 'GRD', 'LastName': 'Jones', 'Affiliation': ""From the Department of Renal Medicine, St. George Hospital (S.V.B., A.T.), the Renal and Metabolic Division, George Institute for Global Health (S.V.B., A.T., V.P.), and St. Vincent's Clinical School (R.O.D., G.R.D.J.), University of New South Wales Medicine, the Departments of Clinical Pharmacology and Toxicology (R.O.D.) and Chemical Pathology, SydPath (G.R.D.J.), St. Vincent's Hospital, the Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney (D.C.H., G.K.R.), the Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District (D.C.H., G.K.R.), and the Department of Nephrology, the Royal North Shore Hospital (V.P.), Sydney, the Australasian Kidney Trials Network, University of Queensland (S.V.B., E.M.P., N.B., C.M.H., D.R., L.R., D.W.J.), the Department of Nephrology, Princess Alexandra Hospital, (B.D., C.M.H., D.W.J.), and the Translational Research Institute (D.W.J.), Brisbane, QLD, the Medical School, University of Western Australia, Perth (N.B.), the Department of Nephrology, Monash University at Monash Medical Centre, Melbourne, VIC (F.G.B., J.K.), Menzies School of Health Research, Charles Darwin University, Darwin, NT (A.C.), the University of Adelaide and Central Northern Adelaide Renal and Transplantation Services, Adelaide, SA (R.F.), and the Australian National University Medical School and the Department of Nephrology, Canberra Hospital, Canberra, ACT (G.W.) - all in Australia; the Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (P.C.); and the Department of Medicine, University of Auckland (N.D., J.R.Z.), and the Renal Service, Waitemata District Health Board (J.R.Z.), Auckland, the Department of Medicine, University of Otago Christchurch, Christchurch (S.C.P.), and Dunedin School of Medicine, University of Otago, Dunedin (R.J.W.) - all in New Zealand.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Kanellis', 'Affiliation': ""From the Department of Renal Medicine, St. George Hospital (S.V.B., A.T.), the Renal and Metabolic Division, George Institute for Global Health (S.V.B., A.T., V.P.), and St. Vincent's Clinical School (R.O.D., G.R.D.J.), University of New South Wales Medicine, the Departments of Clinical Pharmacology and Toxicology (R.O.D.) and Chemical Pathology, SydPath (G.R.D.J.), St. Vincent's Hospital, the Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney (D.C.H., G.K.R.), the Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District (D.C.H., G.K.R.), and the Department of Nephrology, the Royal North Shore Hospital (V.P.), Sydney, the Australasian Kidney Trials Network, University of Queensland (S.V.B., E.M.P., N.B., C.M.H., D.R., L.R., D.W.J.), the Department of Nephrology, Princess Alexandra Hospital, (B.D., C.M.H., D.W.J.), and the Translational Research Institute (D.W.J.), Brisbane, QLD, the Medical School, University of Western Australia, Perth (N.B.), the Department of Nephrology, Monash University at Monash Medical Centre, Melbourne, VIC (F.G.B., J.K.), Menzies School of Health Research, Charles Darwin University, Darwin, NT (A.C.), the University of Adelaide and Central Northern Adelaide Renal and Transplantation Services, Adelaide, SA (R.F.), and the Australian National University Medical School and the Department of Nephrology, Canberra Hospital, Canberra, ACT (G.W.) - all in Australia; the Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (P.C.); and the Department of Medicine, University of Auckland (N.D., J.R.Z.), and the Renal Service, Waitemata District Health Board (J.R.Z.), Auckland, the Department of Medicine, University of Otago Christchurch, Christchurch (S.C.P.), and Dunedin School of Medicine, University of Otago, Dunedin (R.J.W.) - all in New Zealand.""}, {'ForeName': 'Suetonia C', 'Initials': 'SC', 'LastName': 'Palmer', 'Affiliation': ""From the Department of Renal Medicine, St. George Hospital (S.V.B., A.T.), the Renal and Metabolic Division, George Institute for Global Health (S.V.B., A.T., V.P.), and St. Vincent's Clinical School (R.O.D., G.R.D.J.), University of New South Wales Medicine, the Departments of Clinical Pharmacology and Toxicology (R.O.D.) and Chemical Pathology, SydPath (G.R.D.J.), St. Vincent's Hospital, the Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney (D.C.H., G.K.R.), the Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District (D.C.H., G.K.R.), and the Department of Nephrology, the Royal North Shore Hospital (V.P.), Sydney, the Australasian Kidney Trials Network, University of Queensland (S.V.B., E.M.P., N.B., C.M.H., D.R., L.R., D.W.J.), the Department of Nephrology, Princess Alexandra Hospital, (B.D., C.M.H., D.W.J.), and the Translational Research Institute (D.W.J.), Brisbane, QLD, the Medical School, University of Western Australia, Perth (N.B.), the Department of Nephrology, Monash University at Monash Medical Centre, Melbourne, VIC (F.G.B., J.K.), Menzies School of Health Research, Charles Darwin University, Darwin, NT (A.C.), the University of Adelaide and Central Northern Adelaide Renal and Transplantation Services, Adelaide, SA (R.F.), and the Australian National University Medical School and the Department of Nephrology, Canberra Hospital, Canberra, ACT (G.W.) - all in Australia; the Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (P.C.); and the Department of Medicine, University of Auckland (N.D., J.R.Z.), and the Renal Service, Waitemata District Health Board (J.R.Z.), Auckland, the Department of Medicine, University of Otago Christchurch, Christchurch (S.C.P.), and Dunedin School of Medicine, University of Otago, Dunedin (R.J.W.) - all in New Zealand.""}, {'ForeName': 'Vlado', 'Initials': 'V', 'LastName': 'Perkovic', 'Affiliation': ""From the Department of Renal Medicine, St. George Hospital (S.V.B., A.T.), the Renal and Metabolic Division, George Institute for Global Health (S.V.B., A.T., V.P.), and St. Vincent's Clinical School (R.O.D., G.R.D.J.), University of New South Wales Medicine, the Departments of Clinical Pharmacology and Toxicology (R.O.D.) and Chemical Pathology, SydPath (G.R.D.J.), St. Vincent's Hospital, the Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney (D.C.H., G.K.R.), the Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District (D.C.H., G.K.R.), and the Department of Nephrology, the Royal North Shore Hospital (V.P.), Sydney, the Australasian Kidney Trials Network, University of Queensland (S.V.B., E.M.P., N.B., C.M.H., D.R., L.R., D.W.J.), the Department of Nephrology, Princess Alexandra Hospital, (B.D., C.M.H., D.W.J.), and the Translational Research Institute (D.W.J.), Brisbane, QLD, the Medical School, University of Western Australia, Perth (N.B.), the Department of Nephrology, Monash University at Monash Medical Centre, Melbourne, VIC (F.G.B., J.K.), Menzies School of Health Research, Charles Darwin University, Darwin, NT (A.C.), the University of Adelaide and Central Northern Adelaide Renal and Transplantation Services, Adelaide, SA (R.F.), and the Australian National University Medical School and the Department of Nephrology, Canberra Hospital, Canberra, ACT (G.W.) - all in Australia; the Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (P.C.); and the Department of Medicine, University of Auckland (N.D., J.R.Z.), and the Renal Service, Waitemata District Health Board (J.R.Z.), Auckland, the Department of Medicine, University of Otago Christchurch, Christchurch (S.C.P.), and Dunedin School of Medicine, University of Otago, Dunedin (R.J.W.) - all in New Zealand.""}, {'ForeName': 'Gopala K', 'Initials': 'GK', 'LastName': 'Rangan', 'Affiliation': ""From the Department of Renal Medicine, St. George Hospital (S.V.B., A.T.), the Renal and Metabolic Division, George Institute for Global Health (S.V.B., A.T., V.P.), and St. Vincent's Clinical School (R.O.D., G.R.D.J.), University of New South Wales Medicine, the Departments of Clinical Pharmacology and Toxicology (R.O.D.) and Chemical Pathology, SydPath (G.R.D.J.), St. Vincent's Hospital, the Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney (D.C.H., G.K.R.), the Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District (D.C.H., G.K.R.), and the Department of Nephrology, the Royal North Shore Hospital (V.P.), Sydney, the Australasian Kidney Trials Network, University of Queensland (S.V.B., E.M.P., N.B., C.M.H., D.R., L.R., D.W.J.), the Department of Nephrology, Princess Alexandra Hospital, (B.D., C.M.H., D.W.J.), and the Translational Research Institute (D.W.J.), Brisbane, QLD, the Medical School, University of Western Australia, Perth (N.B.), the Department of Nephrology, Monash University at Monash Medical Centre, Melbourne, VIC (F.G.B., J.K.), Menzies School of Health Research, Charles Darwin University, Darwin, NT (A.C.), the University of Adelaide and Central Northern Adelaide Renal and Transplantation Services, Adelaide, SA (R.F.), and the Australian National University Medical School and the Department of Nephrology, Canberra Hospital, Canberra, ACT (G.W.) - all in Australia; the Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (P.C.); and the Department of Medicine, University of Auckland (N.D., J.R.Z.), and the Renal Service, Waitemata District Health Board (J.R.Z.), Auckland, the Department of Medicine, University of Otago Christchurch, Christchurch (S.C.P.), and Dunedin School of Medicine, University of Otago, Dunedin (R.J.W.) - all in New Zealand.""}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Reidlinger', 'Affiliation': ""From the Department of Renal Medicine, St. George Hospital (S.V.B., A.T.), the Renal and Metabolic Division, George Institute for Global Health (S.V.B., A.T., V.P.), and St. Vincent's Clinical School (R.O.D., G.R.D.J.), University of New South Wales Medicine, the Departments of Clinical Pharmacology and Toxicology (R.O.D.) and Chemical Pathology, SydPath (G.R.D.J.), St. Vincent's Hospital, the Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney (D.C.H., G.K.R.), the Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District (D.C.H., G.K.R.), and the Department of Nephrology, the Royal North Shore Hospital (V.P.), Sydney, the Australasian Kidney Trials Network, University of Queensland (S.V.B., E.M.P., N.B., C.M.H., D.R., L.R., D.W.J.), the Department of Nephrology, Princess Alexandra Hospital, (B.D., C.M.H., D.W.J.), and the Translational Research Institute (D.W.J.), Brisbane, QLD, the Medical School, University of Western Australia, Perth (N.B.), the Department of Nephrology, Monash University at Monash Medical Centre, Melbourne, VIC (F.G.B., J.K.), Menzies School of Health Research, Charles Darwin University, Darwin, NT (A.C.), the University of Adelaide and Central Northern Adelaide Renal and Transplantation Services, Adelaide, SA (R.F.), and the Australian National University Medical School and the Department of Nephrology, Canberra Hospital, Canberra, ACT (G.W.) - all in Australia; the Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (P.C.); and the Department of Medicine, University of Auckland (N.D., J.R.Z.), and the Renal Service, Waitemata District Health Board (J.R.Z.), Auckland, the Department of Medicine, University of Otago Christchurch, Christchurch (S.C.P.), and Dunedin School of Medicine, University of Otago, Dunedin (R.J.W.) - all in New Zealand.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Robison', 'Affiliation': ""From the Department of Renal Medicine, St. George Hospital (S.V.B., A.T.), the Renal and Metabolic Division, George Institute for Global Health (S.V.B., A.T., V.P.), and St. Vincent's Clinical School (R.O.D., G.R.D.J.), University of New South Wales Medicine, the Departments of Clinical Pharmacology and Toxicology (R.O.D.) and Chemical Pathology, SydPath (G.R.D.J.), St. Vincent's Hospital, the Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney (D.C.H., G.K.R.), the Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District (D.C.H., G.K.R.), and the Department of Nephrology, the Royal North Shore Hospital (V.P.), Sydney, the Australasian Kidney Trials Network, University of Queensland (S.V.B., E.M.P., N.B., C.M.H., D.R., L.R., D.W.J.), the Department of Nephrology, Princess Alexandra Hospital, (B.D., C.M.H., D.W.J.), and the Translational Research Institute (D.W.J.), Brisbane, QLD, the Medical School, University of Western Australia, Perth (N.B.), the Department of Nephrology, Monash University at Monash Medical Centre, Melbourne, VIC (F.G.B., J.K.), Menzies School of Health Research, Charles Darwin University, Darwin, NT (A.C.), the University of Adelaide and Central Northern Adelaide Renal and Transplantation Services, Adelaide, SA (R.F.), and the Australian National University Medical School and the Department of Nephrology, Canberra Hospital, Canberra, ACT (G.W.) - all in Australia; the Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (P.C.); and the Department of Medicine, University of Auckland (N.D., J.R.Z.), and the Renal Service, Waitemata District Health Board (J.R.Z.), Auckland, the Department of Medicine, University of Otago Christchurch, Christchurch (S.C.P.), and Dunedin School of Medicine, University of Otago, Dunedin (R.J.W.) - all in New Zealand.""}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Walker', 'Affiliation': ""From the Department of Renal Medicine, St. George Hospital (S.V.B., A.T.), the Renal and Metabolic Division, George Institute for Global Health (S.V.B., A.T., V.P.), and St. Vincent's Clinical School (R.O.D., G.R.D.J.), University of New South Wales Medicine, the Departments of Clinical Pharmacology and Toxicology (R.O.D.) and Chemical Pathology, SydPath (G.R.D.J.), St. Vincent's Hospital, the Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney (D.C.H., G.K.R.), the Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District (D.C.H., G.K.R.), and the Department of Nephrology, the Royal North Shore Hospital (V.P.), Sydney, the Australasian Kidney Trials Network, University of Queensland (S.V.B., E.M.P., N.B., C.M.H., D.R., L.R., D.W.J.), the Department of Nephrology, Princess Alexandra Hospital, (B.D., C.M.H., D.W.J.), and the Translational Research Institute (D.W.J.), Brisbane, QLD, the Medical School, University of Western Australia, Perth (N.B.), the Department of Nephrology, Monash University at Monash Medical Centre, Melbourne, VIC (F.G.B., J.K.), Menzies School of Health Research, Charles Darwin University, Darwin, NT (A.C.), the University of Adelaide and Central Northern Adelaide Renal and Transplantation Services, Adelaide, SA (R.F.), and the Australian National University Medical School and the Department of Nephrology, Canberra Hospital, Canberra, ACT (G.W.) - all in Australia; the Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (P.C.); and the Department of Medicine, University of Auckland (N.D., J.R.Z.), and the Renal Service, Waitemata District Health Board (J.R.Z.), Auckland, the Department of Medicine, University of Otago Christchurch, Christchurch (S.C.P.), and Dunedin School of Medicine, University of Otago, Dunedin (R.J.W.) - all in New Zealand.""}, {'ForeName': 'Giles', 'Initials': 'G', 'LastName': 'Walters', 'Affiliation': ""From the Department of Renal Medicine, St. George Hospital (S.V.B., A.T.), the Renal and Metabolic Division, George Institute for Global Health (S.V.B., A.T., V.P.), and St. Vincent's Clinical School (R.O.D., G.R.D.J.), University of New South Wales Medicine, the Departments of Clinical Pharmacology and Toxicology (R.O.D.) and Chemical Pathology, SydPath (G.R.D.J.), St. Vincent's Hospital, the Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney (D.C.H., G.K.R.), the Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District (D.C.H., G.K.R.), and the Department of Nephrology, the Royal North Shore Hospital (V.P.), Sydney, the Australasian Kidney Trials Network, University of Queensland (S.V.B., E.M.P., N.B., C.M.H., D.R., L.R., D.W.J.), the Department of Nephrology, Princess Alexandra Hospital, (B.D., C.M.H., D.W.J.), and the Translational Research Institute (D.W.J.), Brisbane, QLD, the Medical School, University of Western Australia, Perth (N.B.), the Department of Nephrology, Monash University at Monash Medical Centre, Melbourne, VIC (F.G.B., J.K.), Menzies School of Health Research, Charles Darwin University, Darwin, NT (A.C.), the University of Adelaide and Central Northern Adelaide Renal and Transplantation Services, Adelaide, SA (R.F.), and the Australian National University Medical School and the Department of Nephrology, Canberra Hospital, Canberra, ACT (G.W.) - all in Australia; the Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (P.C.); and the Department of Medicine, University of Auckland (N.D., J.R.Z.), and the Renal Service, Waitemata District Health Board (J.R.Z.), Auckland, the Department of Medicine, University of Otago Christchurch, Christchurch (S.C.P.), and Dunedin School of Medicine, University of Otago, Dunedin (R.J.W.) - all in New Zealand.""}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Johnson', 'Affiliation': ""From the Department of Renal Medicine, St. George Hospital (S.V.B., A.T.), the Renal and Metabolic Division, George Institute for Global Health (S.V.B., A.T., V.P.), and St. Vincent's Clinical School (R.O.D., G.R.D.J.), University of New South Wales Medicine, the Departments of Clinical Pharmacology and Toxicology (R.O.D.) and Chemical Pathology, SydPath (G.R.D.J.), St. Vincent's Hospital, the Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney (D.C.H., G.K.R.), the Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District (D.C.H., G.K.R.), and the Department of Nephrology, the Royal North Shore Hospital (V.P.), Sydney, the Australasian Kidney Trials Network, University of Queensland (S.V.B., E.M.P., N.B., C.M.H., D.R., L.R., D.W.J.), the Department of Nephrology, Princess Alexandra Hospital, (B.D., C.M.H., D.W.J.), and the Translational Research Institute (D.W.J.), Brisbane, QLD, the Medical School, University of Western Australia, Perth (N.B.), the Department of Nephrology, Monash University at Monash Medical Centre, Melbourne, VIC (F.G.B., J.K.), Menzies School of Health Research, Charles Darwin University, Darwin, NT (A.C.), the University of Adelaide and Central Northern Adelaide Renal and Transplantation Services, Adelaide, SA (R.F.), and the Australian National University Medical School and the Department of Nephrology, Canberra Hospital, Canberra, ACT (G.W.) - all in Australia; the Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (P.C.); and the Department of Medicine, University of Auckland (N.D., J.R.Z.), and the Renal Service, Waitemata District Health Board (J.R.Z.), Auckland, the Department of Medicine, University of Otago Christchurch, Christchurch (S.C.P.), and Dunedin School of Medicine, University of Otago, Dunedin (R.J.W.) - all in New Zealand.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1915833']
1147,32446245,"Me, myself, bye: regional alterations in glutamate and the experience of ego dissolution with psilocybin.","There is growing interest in the therapeutic utility of psychedelic substances, like psilocybin, for disorders characterized by distortions of the self-experience, like depression. Accumulating preclinical evidence emphasizes the role of the glutamate system in the acute action of the drug on brain and behavior; however this has never been tested in humans. Following a double-blind, placebo-controlled, parallel group design, we utilized an ultra-high field multimodal brain imaging approach and demonstrated that psilocybin (0.17 mg/kg) induced region-dependent alterations in glutamate, which predicted distortions in the subjective experience of one's self (ego dissolution). Whereas higher levels of medial prefrontal cortical glutamate were associated with negatively experienced ego dissolution, lower levels in hippocampal glutamate were associated with positively experienced ego dissolution. Such findings provide further insights into the underlying neurobiological mechanisms of the psychedelic, as well as the baseline, state. Importantly, they may also provide a neurochemical basis for therapeutic effects as witnessed in ongoing clinical trials.",2020,"There is growing interest in the therapeutic utility of psychedelic substances, like psilocybin, for disorders characterized by distortions of the self-experience, like depression.",[],"['psilocybin', 'placebo']","['medial prefrontal cortical glutamate', 'hippocampal glutamate']",[],"[{'cui': 'C0033850', 'cui_str': 'Psilocybine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0017789', 'cui_str': 'Glutamates'}, {'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}]",,0.0862072,"There is growing interest in the therapeutic utility of psychedelic substances, like psilocybin, for disorders characterized by distortions of the self-experience, like depression.","[{'ForeName': 'N L', 'Initials': 'NL', 'LastName': 'Mason', 'Affiliation': 'Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, 6200 MD, Maastricht, the Netherlands. natasha.mason@maastrichtuniversity.nl.'}, {'ForeName': 'K P C', 'Initials': 'KPC', 'LastName': 'Kuypers', 'Affiliation': 'Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, 6200 MD, Maastricht, the Netherlands.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Müller', 'Affiliation': 'Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, 6200 MD, Maastricht, the Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Reckweg', 'Affiliation': 'Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, 6200 MD, Maastricht, the Netherlands.'}, {'ForeName': 'D H Y', 'Initials': 'DHY', 'LastName': 'Tse', 'Affiliation': 'Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, 6200 MD, Maastricht, the Netherlands.'}, {'ForeName': 'S W', 'Initials': 'SW', 'LastName': 'Toennes', 'Affiliation': 'Institute of Legal Medicine, University of Frankfurt, Kennedyallee 104, D-60596, Frankfurt/Main, Germany.'}, {'ForeName': 'N R P W', 'Initials': 'NRPW', 'LastName': 'Hutten', 'Affiliation': 'Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, 6200 MD, Maastricht, the Netherlands.'}, {'ForeName': 'J F A', 'Initials': 'JFA', 'LastName': 'Jansen', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Maastricht University Medical Center+ (MUMC+), Maastricht, the Netherlands.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Stiers', 'Affiliation': 'Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, 6200 MD, Maastricht, the Netherlands.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Feilding', 'Affiliation': 'The Beckley Foundation, Beckley Park, Oxford, OX3 9SY, UK.'}, {'ForeName': 'J G', 'Initials': 'JG', 'LastName': 'Ramaekers', 'Affiliation': 'Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, 6200 MD, Maastricht, the Netherlands. j.ramaekers@maastrichtuniversity.nl.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0718-8']
1148,32446770,Using Self-Reported Measures of Confidence and Anxiety to Determine the Efficacy of the Surgical Exploration And Discovery (SEAD) Program in Reducing Anxiety and Increasing Confidence in Performing Procedural Skills.,"OBJECTIVE


Clerkship students feel increased anxiety and lack of confidence when it comes to surgery. This study assessed whether participation in Surgical Exploration And Discovery (SEAD), a 2-week intensive surgical program that includes career information, simulation workshops, and operating room observerships, would help decrease anxiety, increase confidence, and foster interest in a surgical career.
SETTING


This study took place at The Ottawa Hospital in Ottawa, Ontario, Canada.
DESIGN


Thirty first year medical students were randomly selected for the SEAD program and 32 were only given the program's instruction manual during the duration of the program serving as the control. At baseline and after the completion of SEAD, both groups were given a survey containing the State Trait Anxiety Inventory that measures self-reported anxiety levels with an adjunct that gauges confidence and interest in a surgical career.
RESULTS


Students who participated in the program showed significant improvements in self-perceived knowledge and confidence for each surgical skill: scrubbing (p-value < 0.001, p-value < 0.001), maintaining sterility (p-value < 0.001, p-value < 0.001), and surgical assisting (p-value < 0.001, p-value < 0.001). However, there was no difference in the average state anxiety with procedural skills (p-value = 0.190) between students who participated in SEAD and those who did not. Students who completed SEAD had a notable increase in their interest in pursuing a career in surgery compared with their pretest (p-value = 0.020) and compared with the control group (p-value = 0.600).
CONCLUSIONS


The SEAD program may increase medical students' confidence and interest in pursuing a surgical career. These results encourage offering medical students with similar opportunities that provide exposure to surgery in preclerkship.",2020,"RESULTS


Students who participated in the program showed significant improvements in self-perceived knowledge and confidence for each surgical skill: scrubbing (p-value < 0.001, p-value < 0.001), maintaining sterility (p-value < 0.001, p-value < 0.001), and surgical assisting (p-value < 0.001, p-value < 0.001).","['Thirty first year medical students', 'place at The Ottawa Hospital in Ottawa, Ontario, Canada']","['Surgical Exploration And Discovery (SEAD', 'Surgical Exploration And Discovery (SEAD) Program', ""SEAD program and 32 were only given the program's instruction manual during the duration of the program serving as the control""]","['surgical assisting', 'maintaining sterility', 'State Trait Anxiety Inventory that measures self-reported anxiety levels', 'self-perceived knowledge and confidence for each surgical skill: scrubbing', 'average state anxiety with procedural skills']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0006823', 'cui_str': 'Canada'}]","[{'cui': 'C0184899', 'cui_str': 'Exploratory incision'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}]",,0.0163054,"RESULTS


Students who participated in the program showed significant improvements in self-perceived knowledge and confidence for each surgical skill: scrubbing (p-value < 0.001, p-value < 0.001), maintaining sterility (p-value < 0.001, p-value < 0.001), and surgical assisting (p-value < 0.001, p-value < 0.001).","[{'ForeName': 'Marisa', 'Initials': 'M', 'LastName': 'Market', 'Affiliation': 'University of Ottawa, Ottawa, Ontario, Canada. Electronic address: mmark030@uottawa.ca.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Battaglia', 'Affiliation': 'University of Ottawa, Ottawa, Ontario, Canada. Electronic address: fbatt066@uottawa.ca.'}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Langlois', 'Affiliation': 'University of Ottawa, Ottawa, Ontario, Canada. Electronic address: elang086@uottawa.ca.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Shin', 'Affiliation': 'University of Ottawa, Ottawa, Ontario, Canada. Electronic address: jshin059@uottawa.ca.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Seabrook', 'Affiliation': 'The Ottawa Hospital, Department of Surgery, Division of Vascular Surgery, Ottawa, Ontario, Canada.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Brandys', 'Affiliation': 'The Ottawa Hospital, Department of Surgery, Division of Vascular Surgery, Ottawa, Ontario, Canada.'}]",Journal of surgical education,['10.1016/j.jsurg.2020.03.010']
1149,32447641,Potential roles of lymphovascular space invasion based on tumor characteristics provide important prognostic information in T1 tumors with ER and HER2 positive breast cancer.,"PURPOSE


Patients presenting with lymphovascular space invasion (LVSI) had an absolute decrease in survival. In our present study, the potential roles of LVSI on tumor characteristics was explored to predict the difference in the prognosis of ER and HER2 positive T1 tumors.
METHODS


A total of 142 breast cancer patients diagnosed with ER+ and HER2+ tumors whose tumor size was ≤ 2 cm were included in this analysis. One hundred forty-two patients were divided into four groups, group 1 (lymph nodes+ and LVSI+), group 2 (lymph nodes+ and LVSI-), group 3 (lymph nodes- and LVSI+), group 4 (lymph nodes- and LVSI-). Univariate and multivariate Cox proportional hazard models were used to identify independent prognostic factors and calculate the HR and 95% CI. Kaplan-Meier and Cox regression models were used to test the prognostic significance.
RESULTS


LVSI positivity was significantly associated with patient age, menopausal status, tumor size, lymph node status, Ki67, PR, and tumor grade. In the univariate and multivariate model, LVSI, PR, and Ki67 were significantly associated with DFS, and LVSI, lymph node status, PR, and Ki67 were significantly associated with OS. LVSI was significantly related to increased risk of DFS and OS only in the PR-negative and low-positive subgroups. It was a prognostic factor for DFS but not for OS in women with low Ki67 and was associated with DFS and OS in high-Ki67 tumors. Furthermore, patients who presented with only LVSI had a significantly worse survival rate than those with lymph node metastasis without LVSI in small tumors.
CONCLUSION


The presence of LVSI was highlighted as a variable significant to survival. In further clinical practice, patients with LVSI may need more intensive treatment in certain populations.",2020,LVSI was significantly related to increased risk of DFS and OS only in the PR-negative and low-positive subgroups.,"['One hundred forty-two patients', '142 breast cancer patients diagnosed with ER+\u2009and HER2+\u2009tumors whose tumor size was\u2009≤\u20092\xa0cm', 'Patients presenting with lymphovascular space invasion (LVSI', 'T1 tumors with ER and HER2 positive breast cancer']","['group 1 (lymph nodes+\u2009and LVSI+), group 2 (lymph nodes+\u2009and LVSI-), group 3 (lymph nodes- and LVSI+), group 4 (lymph nodes- and LVSI']","['LVSI positivity', 'DFS, and LVSI, lymph node status, PR, and Ki67', 'survival rate', 'survival', 'risk of DFS and OS']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0279754', 'cui_str': 'ESR1 positive'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0475440', 'cui_str': 'Tumor size'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C1269955', 'cui_str': 'Tumour invasion'}, {'cui': 'C1960398', 'cui_str': 'HER2-positive carcinoma of breast'}]","[{'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0024202', 'cui_str': 'Lymph'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C1269955', 'cui_str': 'Tumour invasion'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}, {'cui': 'C0441876', 'cui_str': 'Group 4'}]","[{'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C1269955', 'cui_str': 'Tumour invasion'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",142.0,0.023952,LVSI was significantly related to increased risk of DFS and OS only in the PR-negative and low-positive subgroups.,"[{'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Department of Breast Surgery, The Tumor Affiliated Hospital of Harbin Medical University, Harbin, China.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Yang', 'Affiliation': 'Department of Oncology, The Fourth Affiliated Hospital of Harbin Medical University, Harbin, China.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of In-Pantient Ultrasound, The Second Affiliated Hospital of Harbin Medical University, Harbin, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Department of Breast Surgery, The Tumor Affiliated Hospital of Harbin Medical University, Harbin, China.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Department of In-Pantient Ultrasound, The Second Affiliated Hospital of Harbin Medical University, Harbin, China.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'Department of Surgery, The Second Affiliated Hospital of Harbin Medical University, 246 Xuefu Road, Harbin, 150086, Heilongjiang, China. mugong0@163.com.'}]",Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico,['10.1007/s12094-020-02369-9']
1150,32454191,Patient Perceptions in a Nonblinded Randomized Trial of Radiation Therapy Technologies: A Novel Survey Study Exploring Therapeutic Misconception.,"PURPOSE


Therapeutic misconception is the tendency for a clinical trial participant to overlook the scientific objective of a clinical trial and instead believe that an experimental intervention is intended for personal therapeutic benefit. We sought to evaluate this tendency in the setting of a clinical trial of a new radiation therapy technology.
METHODS


Patients with left-sided, node positive breast cancer enrolled in a randomized clinical trial evaluating intensity modulated radiation therapy with deep inspiration breath hold (IMRT-DIBH) versus 3-dimensional conformal radiation therapy (3DCRT). Patients who enrolled completed surveys at baseline, after randomization, and upon completion of radiation therapy to evaluate expectations, satisfaction, and experiences.
RESULTS


Forty women participated in the survey study, with 20 in each arm. Most participants endorsed the perception that participation in the trial might result in better treatment than the current standard treatment (77%) and more medical attention than being off trial (54%). At baseline, most women (74%) believed that a new treatment technology is superior than an established one. Before randomization, 43% of participants believed IMRT-DIBH would be more effective than standard treatment with 3DCRT, none believed that 3DCRT would be more effective, 23% believed that they would be the same, and 34% did not know. None believed that IMRT-DIBH would cause worse long-term side effects, whereas 37% thought that 3DCRT would. Most (71%) reported that they would choose to be treated with IMRT-DIBH; none would have elected 3DCRT if given a choice. Nearly half (44%) in the 3DCRT arm wished that they had been assigned to the IMRT-DIBH arm; none in the IMRT-DIBH arm expressed a wish for crossover.
CONCLUSIONS


Most participants reported the perception that trial participation would result in better treatment and more medical attention than off trial, hallmarks of therapeutic misconception. Our observations provide empirical evidence of a fixed belief in the superiority of new technology and highlight the importance of adjusting expectations through informed consent to mitigate therapeutic misconception.",2020,"Nearly half (44%) in the 3DCRT arm wished that they had been assigned to the IMRT-DIBH arm; none in the IMRT-DIBH arm expressed a wish for crossover.
","['35 women surveyed', 'Patients with breast cancer enrolled']","['3DCRT', 'Radiotherapy Technologies', 'intensity modulated radiotherapy with deep inspiration breath hold (IMRT-DIBH) versus 3-dimensional conformal radiotherapy (3DCRT']",['medical attention'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}]","[{'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0600521', 'cui_str': 'Conformal radiotherapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0235744', 'cui_str': 'Interrupted breathing'}]","[{'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",35.0,0.156869,"Nearly half (44%) in the 3DCRT arm wished that they had been assigned to the IMRT-DIBH arm; none in the IMRT-DIBH arm expressed a wish for crossover.
","[{'ForeName': 'Dean A', 'Initials': 'DA', 'LastName': 'Shumway', 'Affiliation': 'Department of Radiation Oncology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Motomura', 'Affiliation': 'Center for Law and the Biosciences and Stanford Program in Neuroscience and Society, Stanford Law School, Stanford, California.'}, {'ForeName': 'Kent A', 'Initials': 'KA', 'LastName': 'Griffith', 'Affiliation': 'Department of Radiation Oncology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Hayman', 'Affiliation': 'Department of Radiation Oncology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Lori J', 'Initials': 'LJ', 'LastName': 'Pierce', 'Affiliation': 'Department of Radiation Oncology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Reshma', 'Initials': 'R', 'LastName': 'Jagsi', 'Affiliation': 'Department of Radiation Oncology, University of Michigan, Ann Arbor, Michigan. Electronic address: rjagsi@med.umich.edu.'}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2020.05.021']
1151,32448299,Acceptability and feasibility of a behavioral and mobile health intervention (COMBIND) shown to increase uptake of prevention of mother to child transmission (PMTCT) care in India.,"BACKGROUND


A cluster-randomized trial recently demonstrated that an integrated behavioral and mobile technology intervention improved uptake of key components of a Prevention of Mother to Child Transmission (PMTCT) Option B+ program, among HIV- infected pregnant/breastfeeding women in India. To guide scale-up and optimize programmatic implementation, we conducted a mixed-methods evaluation of the feasibility and acceptability of this intervention.
METHODS


The COMmunity Home Based INDia (COMBIND) study, was conducted in four districts of Maharashtra, India and randomized 119 integrated counseling and testing centers (ICTC) and their outreach workers (ORWs) to the COMBIND intervention, an integrated mHealth application that allowed digital data capture, PMTCT educational videos, SMS alerts for missed visits and reminder for visits, combined with personal empowerment and motivational interviewing training for ORWs. This qualitative evaluation was done through 15 in-depth interviews (IDIs) with ORWs and 15 IDIs with HIV-infected pregnant/breastfeeding women from the intervention arm. Utilizing a concurrent nested mixed-method evaluation approach, we assess the feasibility and acceptability of the study intervention.
RESULTS


All 30 participants reported that the PMTCT videos were essential in providing easy to understand information on critical aspects of HIV and necessary care related to PMTCT practices. A majority of the ORWs reported that the personal empowerment training with motivational interviewing skills training increased their confidence, motivation and gave them the tools for effectively supporting their clients. The mHealth application improved their working style as it facilitated targeted PMTCT information support, systemized data capture, streamlined their health education delivery practice and provided a sense of work satisfaction. The SMS appointment alerts improved retention in HIV care for mother and baby to the smaller proportion that had access to their phones. Despite reported improvements in knowledge and communication, few ORWs reported that structural challenges such as limited drug stocks, lack of HIV kits or unavailability of trained staff at ICTC, may hamper the uptake of PMTCT services, thus resulting in limited significant impacts of COMBIND on PMTCT outcomes.
CONCLUSION


This study found that COMBIND intervention is scalable, feasible, beneficial and very well accepted by ORWs and patients, however structural challenges in goods and services remain.",2020,All 30 participants reported that the PMTCT videos were essential in providing easy to understand information on critical aspects of HIV and necessary care related to PMTCT practices.,"['mother to child transmission (PMTCT) care in India', 'Mother to Child Transmission (PMTCT', 'four districts of Maharashtra, India and randomized 119 integrated counseling and testing centers (ICTC) and their outreach workers (ORWs) to the', 'HIV- infected pregnant/breastfeeding women in India', 'The COMmunity Home Based INDia']","['COMBIND intervention, an integrated mHealth application that allowed digital data capture, PMTCT educational videos, SMS alerts for missed visits and reminder for visits, combined with personal empowerment and motivational interviewing training for ORWs', 'behavioral and mobile health intervention (COMBIND']","['feasibility and acceptability', 'retention in HIV care']","[{'cui': 'C0282474', 'cui_str': 'Infection Transmission, Maternal-Fetal'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0282474', 'cui_str': 'Infection Transmission, Maternal-Fetal'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0795864', 'cui_str': 'Smith-Magenis syndrome'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}]",119.0,0.0351705,All 30 participants reported that the PMTCT videos were essential in providing easy to understand information on critical aspects of HIV and necessary care related to PMTCT practices.,"[{'ForeName': 'Nishi', 'Initials': 'N', 'LastName': 'Suryavanshi', 'Affiliation': 'Lakshya Society for Public Health Education and Research, 307, Block II, Llyod Chambers, Mangalwar Peth, Pune, Maharashtra, 411001, India. nishisuryavanshi@hotmail.com.'}, {'ForeName': 'Abhay', 'Initials': 'A', 'LastName': 'Kadam', 'Affiliation': 'Lakshya Society for Public Health Education and Research, 307, Block II, Llyod Chambers, Mangalwar Peth, Pune, Maharashtra, 411001, India.'}, {'ForeName': 'Savita', 'Initials': 'S', 'LastName': 'Kanade', 'Affiliation': 'Lakshya Society for Public Health Education and Research, 307, Block II, Llyod Chambers, Mangalwar Peth, Pune, Maharashtra, 411001, India.'}, {'ForeName': 'Nikhil', 'Initials': 'N', 'LastName': 'Gupte', 'Affiliation': 'Johns Hopkins University, School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Amita', 'Initials': 'A', 'LastName': 'Gupta', 'Affiliation': 'Johns Hopkins University, School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Bollinger', 'Affiliation': 'Johns Hopkins University, School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Vidya', 'Initials': 'V', 'LastName': 'Mave', 'Affiliation': 'Johns Hopkins University, School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Shankar', 'Affiliation': 'Johns Hopkins University, Bloomberg School of Public Health, Baltimore, MD, USA.'}]",BMC public health,['10.1186/s12889-020-08706-5']
1152,32452588,"A Phase II, Single-Arm, Open-Label, Bayesian Adaptive Efficacy and Safety Study of PBI-05204 in Patients with Stage IV Metastatic Pancreatic Adenocarcinoma.","LESSONS LEARNED


This trial evaluating a novel plant extract, PBI-05204, did not meet its primary endpoint of overall survival but did show signals of efficacy in heavily pretreated mPDA. PBI-05204 was generally well tolerated, with the most common side effects related to treatment being vomiting (23.7%), nausea (18.4%), decreased appetite (18.4%), and diarrhea (15.8%). Additional trials are needed to explore the role of PBI-05204 in cancer treatment.
BACKGROUND


Survival for metastatic pancreatic ductal adenocarcinoma (mPDA) is dismal, and novel agents are needed. PBI-05204 is a modified supercritical carbon dioxide extract of Nerium oleander leaves. Oleandrin, the extract's major cytotoxic component, is a cardiac glycoside that has demonstrated antitumor activity in various tumor cell lines with a mechanism involving inhibition of Akt phosphorylation and through downregulation of mTOR.
METHODS


A phase II, single-arm, open-label study to determine the efficacy of PBI-05204 in patients with refractory mPDA therapy was conducted. The primary endpoint was overall survival (OS), with the hypothesis that 50% of patients would be alive at 4.5 months. Secondary objectives included safety, progression-free survival (PFS), and overall response rate. Patients received oral PBI-05204 daily until progressive disease (PD), unacceptable toxicity, or patient withdrawal. Radiographic response was assessed every two cycles.
RESULTS


Forty-two patients were enrolled, and 38 were analyzed. Ten patients were alive at 4.5 months (26.3%) with a median PFS of 56 days. One objective response (2.6%) was observed for 162 days. Grade ≥ 3 treatment-emergent adverse events occurred in 63.2% of patients with the most common being fatigue, vomiting, nausea, decreased appetite, and diarrhea.
CONCLUSION


PBI-05204 did not meet its primary endpoint for OS in this study. Recent preclinical data indicate a role for PBI-05204 against glioblastoma multiforme when combined with chemotherapy and radiotherapy. A randomized phase II trial is currently being designed.",2020,"3 treatment-emergent adverse events occurred in 63.2% of patients with the most common being fatigue, vomiting, nausea, decreased appetite, and diarrhea.
","['patients with refractory mPDA therapy was conducted', 'metastatic pancreatic ductal adenocarcinoma (mPDA', 'Forty-two patients were enrolled, and 38 were analyzed', 'Patients with Stage IV Metastatic Pancreatic Adenocarcinoma']","['PBI-05204', 'chemotherapy and radiotherapy', 'Oleandrin']","['diarrhea', 'fatigue, vomiting, nausea, decreased appetite, and diarrhea', 'overall survival', 'Radiographic response', 'vomiting', 'Grade ≥', 'safety, progression-free survival (PFS), and overall response rate', 'adverse events', 'nausea', 'overall survival (OS', 'decreased appetite']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C1335302', 'cui_str': 'Ductal adenocarcinoma of pancreas'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4'}, {'cui': 'C0861727', 'cui_str': 'Pancreatic adenocarcinoma metastatic'}]","[{'cui': 'C2987707', 'cui_str': 'PBI-05204'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0069397', 'cui_str': 'Oleandrin'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0232462', 'cui_str': 'Decrease in appetite'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",10.0,0.0807327,"3 treatment-emergent adverse events occurred in 63.2% of patients with the most common being fatigue, vomiting, nausea, decreased appetite, and diarrhea.
","[{'ForeName': 'Marc T', 'Initials': 'MT', 'LastName': 'Roth', 'Affiliation': 'Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Dana Backlund', 'Initials': 'DB', 'LastName': 'Cardin', 'Affiliation': 'Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Erkut Hasan', 'Initials': 'EH', 'LastName': 'Borazanci', 'Affiliation': 'HonorHealth Research Institute, Scottsdale, Arizona, USA.'}, {'ForeName': 'Margaux', 'Initials': 'M', 'LastName': 'Steinbach', 'Affiliation': 'HonorHealth Research Institute, Scottsdale, Arizona, USA.'}, {'ForeName': 'Vincent J', 'Initials': 'VJ', 'LastName': 'Picozzi', 'Affiliation': 'Virginia Mason Hospital and Medical Center, Seattle, Washington, USA.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Rosemury', 'Affiliation': 'AdventHealth Tampa, Tampa, Florida, USA.'}, {'ForeName': 'Raymond Couric', 'Initials': 'RC', 'LastName': 'Wadlow', 'Affiliation': 'Virginia Cancer Specialists, Fairfax, Virginia, USA.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Newman', 'Affiliation': 'MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Berlin', 'Affiliation': 'Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, USA.'}]",The oncologist,['10.1634/theoncologist.2020-0440']
1153,32449919,Orthostatic Blood Pressure Recovery Is Associated With the Rate of Cognitive Decline and Mortality in Clinical Alzheimer's Disease.,"BACKGROUND


Impaired recovery of blood pressure (BP) after standing has been shown to be related to cognitive function and mortality in people without dementia, but its role in people with Alzheimer's disease (AD) is unknown. The aim of this study was to investigate the association of the orthostatic BP response with cognitive decline and mortality in AD.
METHODS


In this post hoc analysis of a randomized controlled trial (Nilvad), we measured the beat-to-beat response of BP upon active standing in mild-to-moderate AD. This included the initial drop (nadir within 40 seconds) and recovery after 1 minute, both expressed relative to resting values. We examined the relationship between a small or large initial drop (median split) and unimpaired (≥100%) or impaired recovery (<100%) with 1.5-year change in Alzheimer's Disease Assessment-cognitive subscale (ADAS-cog) scores and all-cause mortality.
RESULTS


We included 55 participants (age 73.1 ± 6.2 years). Impaired BP recovery was associated with higher increases in ADAS-cog scores (systolic: β [95% confidence interval] = 5.6 [0.4-10.8], p = .035; diastolic: 7.6 [2.3-13.0], p = .006). During a median follow-up time of 49 months, 20 participants died. Impaired BP recovery was associated with increased mortality (systolic: HR [95% confidence interval] = 2.9 [1.1-7.8], p = .039; diastolic: HR [95% confidence interval] = 5.5 [1.9-16.1], p = .002). The initial BP drop was not associated with any outcome. Results were adjusted for age, sex, and intervention group.
CONCLUSIONS


Failure to fully recover BP after 1 minute of standing is associated with cognitive decline and mortality in AD. As such, BP recovery can be regarded as an easily obtained marker of progression rate of AD.",2020,"Impaired BP recovery was associated with increased mortality (systolic: HR [95% CI]=2.9 [1.1-7.8], p=0.039; diastolic: HR [95%","[""people with Alzheimer's disease (AD"", '55 participants (age 73.1±6.2 years']",[],"['mortality (systolic: HR', 'orthostatic BP response', 'Impaired BP recovery', 'ADAS-cog scores (systolic: β', 'blood pressure (BP', 'Orthostatic blood pressure recovery', ""Alzheimer's Disease Assessment-cognitive subscale (ADAS-cog) scores and all-cause mortality""]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],"[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C1997183', 'cui_str': 'Speed of blood pressure response'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0459443', 'cui_str': 'Subscale score'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",55.0,0.363489,"Impaired BP recovery was associated with increased mortality (systolic: HR [95% CI]=2.9 [1.1-7.8], p=0.039; diastolic: HR [95%","[{'ForeName': 'Rianne A A', 'Initials': 'RAA', 'LastName': 'de Heus', 'Affiliation': 'Department of Geriatric Medicine, Radboudumc Alzheimer Center, Radboud University Medical Center, Donders Institute for Brain Cognition and Behaviour, Nijmegen, The Netherlands.'}, {'ForeName': 'Daan L K', 'Initials': 'DLK', 'LastName': 'de Jong', 'Affiliation': 'Department of Geriatric Medicine, Radboudumc Alzheimer Center, Radboud University Medical Center, Donders Institute for Brain Cognition and Behaviour, Nijmegen, The Netherlands.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Rijpma', 'Affiliation': 'Department of Geriatric Medicine, Radboudumc Alzheimer Center, Radboud University Medical Center, Donders Institute for Brain Cognition and Behaviour, Nijmegen, The Netherlands.'}, {'ForeName': 'Brian A', 'Initials': 'BA', 'LastName': 'Lawlor', 'Affiliation': ""Mercer's Institute for Research on Ageing, St. James's Hospital, Dublin, Ireland.""}, {'ForeName': 'Marcel G M', 'Initials': 'MGM', 'LastName': 'Olde Rikkert', 'Affiliation': 'Department of Geriatric Medicine, Radboudumc Alzheimer Center, Radboud University Medical Center, Donders Institute for Brain Cognition and Behaviour, Nijmegen, The Netherlands.'}, {'ForeName': 'Jurgen A H R', 'Initials': 'JAHR', 'LastName': 'Claassen', 'Affiliation': 'Department of Geriatric Medicine, Radboudumc Alzheimer Center, Radboud University Medical Center, Donders Institute for Brain Cognition and Behaviour, Nijmegen, The Netherlands.'}]","The journals of gerontology. Series A, Biological sciences and medical sciences",['10.1093/gerona/glaa129']
1154,32451203,Determination of the Effectiveness of Informing With the Guidance of an Education Booklet in Patients Undergoing Colonoscopy-A Randomized Controlled Trial.,"PURPOSE


The aim of this study was to determine the effect of precolonoscopy information with the guidance of an education booklet on anxiety and bowel preparation adequacy in patients undergoing colonoscopy.
DESIGN


A randomized controlled study.
METHODS


The education group was informed face to face by the researcher with the guidance of the colonoscopy education booklet and provided the education booklet. The control group received usual care.
FINDINGS


The mean state and trait anxiety scores of the patients in the education group were found to be significantly lower than the control group. In the education group, the bowel preparation adequacy was determined to be higher compared with the control group.
CONCLUSIONS


Informing patients with the guidance of the education booklet before the colonoscopy decreased patients' state and trait anxiety levels and increased their bowel preparation adequacy.",2020,The mean state and trait anxiety scores of the patients in the education group were found to be significantly lower than the control group.,"['Patients Undergoing Colonoscopy', 'patients undergoing colonoscopy']","['precolonoscopy', 'usual care', 'education booklet', 'Education Booklet', 'colonoscopy education booklet and provided the education booklet']","['bowel preparation adequacy', 'anxiety and bowel preparation adequacy', 'mean state and trait anxiety scores', ""patients' state and trait anxiety levels""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}]","[{'cui': 'C0455052', 'cui_str': 'Preparation of bowel for procedure'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}]",,0.0400547,The mean state and trait anxiety scores of the patients in the education group were found to be significantly lower than the control group.,"[{'ForeName': 'Zeynep Kızılcık', 'Initials': 'ZK', 'LastName': 'Özkan', 'Affiliation': 'Department of Surgical Nursing, Faculty of Health Sciences, Trakya University, Edirne, Turkey. Electronic address: zeynepkizilcik26@hotmail.com.'}, {'ForeName': 'Ümmü Yıldız', 'Initials': 'ÜY', 'LastName': 'Fındık', 'Affiliation': 'Department of Surgical Nursing, Faculty of Health Sciences, Trakya University, Edirne, Turkey.'}]",Journal of perianesthesia nursing : official journal of the American Society of PeriAnesthesia Nurses,['10.1016/j.jopan.2019.12.009']
1155,32451212,"Efficacy, immunogenicity and safety of a trivalent live human-lamb reassortant rotavirus vaccine (LLR3) in healthy Chinese infants: A randomized, double-blind, placebo-controlled trial.","BACKGROUND


A randomized, double-blind, placebo-controlled multicenter trial was conducted in healthy Chinese infants to assess the efficacy, immunogenicity and safety of a novel trivalent live human-lamb reassortant rotavirus vaccine (LLR3) against rotavirus gastroenteritis (RVGE).
METHODS


Healthy children aged 6-13 weeks were enrolled and randomized (1:1) to either 3 oral doses of LLR3 or placebo according to a 0, 1, 2 month schedule. The objectives were to evaluate vaccine efficacy (VE) against RVGE of any-severity, severe RVGE (sRVGE) and inpatient caused by rotavirus serotypes contained in the vaccine and not contained in the vaccine after the third dose. Immunogenicity was also assayed in a subgroup. All adverse events (AEs) were collected from 30 min after each dose for immediate reaction, even to the entire study period, including the serious AEs (SAEs) and intussusception.
RESULTS


VE against RVGE of any-severity, sRVGE and inpatient caused by any serotype was 56.6% (95% CI: 50.7, 61.8), 70.3% (95% CI: 60.6, 77.6) and 74.0% (95% CI: 57.5, 84.1) respectively. VE against RVGE of any-severity, sRVGE caused by serotypes not contained in vaccine were 54.2% (95% CI: 47.5, 60.1) and 70.4% (95% CI: 60.4, 77.9). The rate of seroconversion and four-fold increase of rotavirus serotype G2-, G3-, and G4-specific IgA is 60.8%, 58.0%, and 60.6% in vaccine group, which was higher than 21.35%, 22.7%, and 23.1% in placebo group (p < 0.0001 for G2, G3, G4), as well as the Geometric Mean Titer (GMT). Through the entire trial, 65.91% and 67.79% of participants reported at least one AE, and 0.02% and 0.02% reported SAEs in the vaccine and placebo groups, respectively. Two intussusception cases were reported both in vaccine and placebo group.
CONCLUSIONS


In Chinese infants, LLR3 provided a substantial protection against RVGE of any-severity, sRVGE and inpatient caused by any serotype, and showed well immunogenicity and safety.",2020,"In Chinese infants, LLR3 provided a substantial protection against RVGE of any-severity, sRVGE and inpatient caused by any serotype, and showed well immunogenicity and safety.","['healthy Chinese infants', 'Healthy children aged 6-13\xa0weeks']","['trivalent live human-lamb reassortant rotavirus vaccine (LLR3', 'novel trivalent live human-lamb reassortant rotavirus vaccine (LLR3', 'LLR3 or placebo', 'placebo']","['efficacy, immunogenicity and safety', 'vaccine efficacy (VE) against RVGE of any-severity, severe RVGE (sRVGE) and inpatient caused by rotavirus serotypes', 'rotavirus serotype G2-, G3-, and G4-specific IgA', 'rate of seroconversion', 'Geometric Mean Titer (GMT', 'Efficacy, immunogenicity and safety', 'immunogenicity and safety', 'Immunogenicity']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0406810', 'cui_str': 'Carney complex'}, {'cui': 'C0597418', 'cui_str': 'Rotavirus vaccine'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0343363', 'cui_str': 'Viral gastroenteritis due to Rotavirus'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0035870', 'cui_str': 'Rotavirus'}, {'cui': 'C0036759', 'cui_str': 'Serotyping'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0475208', 'cui_str': 'Titer'}]",,0.734975,"In Chinese infants, LLR3 provided a substantial protection against RVGE of any-severity, sRVGE and inpatient caused by any serotype, and showed well immunogenicity and safety.","[{'ForeName': 'Shengli', 'Initials': 'S', 'LastName': 'Xia', 'Affiliation': 'Henan Center for Disease Control and Prevention, Zhengzhou 450000, China.'}, {'ForeName': 'Jialiang', 'Initials': 'J', 'LastName': 'Du', 'Affiliation': 'National Institutes for Food and Drug Control, Beijing 102629, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Su', 'Affiliation': 'Henan Center for Disease Control and Prevention, Zhengzhou 450000, China.'}, {'ForeName': 'Yueyue', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'National Institutes for Food and Drug Control, Beijing 102629, China.'}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': 'Henan Center for Disease Control and Prevention, Zhengzhou 450000, China.'}, {'ForeName': 'Qingchuan', 'Initials': 'Q', 'LastName': 'Yu', 'Affiliation': 'National Institutes for Food and Drug Control, Beijing 102629, China.'}, {'ForeName': 'Zhiqiang', 'Initials': 'Z', 'LastName': 'Xie', 'Affiliation': 'Henan Center for Disease Control and Prevention, Zhengzhou 450000, China.'}, {'ForeName': 'Jiamei', 'Initials': 'J', 'LastName': 'Gao', 'Affiliation': 'National Institutes for Food and Drug Control, Beijing 102629, China.'}, {'ForeName': 'Bianli', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': 'Henan Center for Disease Control and Prevention, Zhengzhou 450000, China.'}, {'ForeName': 'Xuejun', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': 'Lanzhou Institute of Biological Products Co Ltd, Lanzhou 730046, China.'}, {'ForeName': 'Tai', 'Initials': 'T', 'LastName': 'Guo', 'Affiliation': 'National Institutes for Food and Drug Control, Beijing 102629, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'National Institutes for Food and Drug Control, Beijing 102629, China. Electronic address: liuyan418@nifdc.org.cn.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Lanzhou Institute of Biological Products Co Ltd, Lanzhou 730046, China. Electronic address: kathzhou@sina.com.'}, {'ForeName': 'Huan', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China. Electronic address: 13691354049@163.com.'}]",Vaccine,['10.1016/j.vaccine.2020.04.038']
1156,32451220,Effectiveness of a communication skills training program for medical students to identify patients communicative clues.,"OBJECTIVE


This study explores whether an Experiential Training Programme (ETP) in communication skills (CS) improves students' ability to identify patients clues compared to those who follow a non-experiential training throughout their medical studies.
METHOD


Intervention Group (IG): 85 4th-year medical students who received the ETP and Control Group (CG): 67 recently graduated students who did not receive it. Their immediate (written) response was requested to three expressions offered by patients containing communicative clues. The answers were grouped into 2 categories: Clue recognised and response patient-centred and the opposite. Three researchers analysed the answers.
RESULTS


Responses 366 (65 from the CG and 77 from the IG): 280 did not recognise clues: 131 (62%) in IG and 149 (96%) in CG and 86 recognised them: 80 (37.9%) in IG and 6 (3.9%) in CG (p = 0.000). Some clues were more elusive than others (p = 0,003).
CONCLUSIONS


The students who received the ETP in CS showed greater ability to explore patients perspective taking advantage of different types of communicative clues than those who did not receive it in a non-relational context.
PRACTICE IMPLICATIONS


Further research is needed to assess whether this ability is maintained in simulated or real clinical situations.",2020,"Some clues were more elusive than others (p = 0,003).
","['Intervention Group (IG): 85 4th-year medical students who received the', 'medical students to identify patients communicative clues']","['Experiential Training Programme (ETP) in communication skills (CS', 'ETP and Control Group (CG): 67 recently graduated students who did not receive it', 'communication skills training program', 'ETP in CS']",[],"[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C1269815', 'cui_str': 'Patient identification'}, {'cui': 'C0009452', 'cui_str': 'Communication'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0870313', 'cui_str': 'Communication skills'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0588053', 'cui_str': 'Graduate'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0588407', 'cui_str': 'Communication skills training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",[],,0.0212889,"Some clues were more elusive than others (p = 0,003).
","[{'ForeName': 'Roger Ruiz', 'Initials': 'RR', 'LastName': 'Moral', 'Affiliation': 'School of Medicine, Universidad Francisco de Vitoria, Madrid, Spain; Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC), Córdoba, University, Córdoba, Spain. Electronic address: r.ruiz.prof@ufv.es.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Andrade-Rosa', 'Affiliation': 'Department of Primary Care, Los Castillos Health Centre, Alcorcón, Madrid, Spain.'}, {'ForeName': 'Juan D Molina', 'Initials': 'JDM', 'LastName': 'Martín', 'Affiliation': 'Department of Psychiatry, Villaverde Mental Health Centre, Hospital 12 De Octubre, Madrid, Spain.'}, {'ForeName': 'Emilio Cervera', 'Initials': 'EC', 'LastName': 'Barba', 'Affiliation': 'School of Medicine, Universidad Francisco De Vitoria, Madrid, Spain.'}, {'ForeName': 'Luis Pérula', 'Initials': 'LP', 'LastName': 'de Torres', 'Affiliation': 'Department of Primary Care Córdoba, Instituto Maimónides De Investigación Biomédica De Córdoba (IMIBIC), Córdoba University, Córdoba, Spain.'}, {'ForeName': 'Diana Monge', 'Initials': 'DM', 'LastName': 'Martín', 'Affiliation': 'School of Medicine, Universidad Francisco De Vitoria, Madrid, Spain.'}]",Patient education and counseling,['10.1016/j.pec.2020.05.018']
1157,32449942,Effects of Prazosin on Provoked Alcohol Craving and Autonomic and Neuroendocrine Response to Stress in Alcohol Use Disorder.,"BACKGROUND


Chronic alcohol use results in changes to stress biology and autonomic arousal contributing to acute alcohol withdrawal symptoms, neuroendocrine tolerance of the hypothalamic-pituitary-adrenal axis responses, high stress-induced craving, and risk of alcohol relapse. Thus, stress coping and recovery from alcohol during early abstinence may be jeopardized by such stress system dysfunction. Significant preclinical evidence suggests that noradrenergic disruption may contribute to these alcohol-related stress arousal changes and that alpha-1 adrenergic antagonists, such as prazosin, may normalize these stress system adaptations and reduce alcohol intake. Thus, we hypothesized that prazosin would reduce stress-induced craving and improve neuroendocrine and autonomic response to stress and alcohol cue exposure during early abstinence. We secondarily also assessed the role of lifetime anxiety disorders on these prazosin effects.
METHODS


Forty inpatient treatment-seeking alcohol-dependent individuals were randomly assigned to receive placebo (n = 18) or 16 mg/d, T.I.D., prazosin (n = 22) in a double-blind manner, titrated over 2 weeks. In weeks 3 to 4 after achieving full dose, patients were exposed to 3 5-minute personalized guided imagery conditions (stress cue, alcohol cue, neutral/relaxing cue), on 3 consecutive days in a random, counterbalanced order. Alcohol craving, anxiety, heart rate, cortisol, and adrenocorticotropic hormone (ACTH) levels were assessed at baseline, following imagery and at repeated recovery timepoints.
RESULTS


Prazosin reduced stress cue-induced alcohol craving (p < 0.05) and stress- and alcohol cue-induced anxiety (p < 0.05) and increased heart rate responses in all imagery conditions (p < 0.05). Prazosin lowered basal cortisol and ACTH (p's < 0.05) and attenuated stress cue-induced rises in cortisol (p < 0.05) versus placebo. Finally, in those without lifetime anxiety disorder, the placebo group showed stress- and alcohol cue-induced increases in cortisol (p's < 0.05), while the prazosin group did not.
CONCLUSIONS


Prazosin may attenuate stress cue-induced alcohol craving and anxiety during early abstinence while improving adrenergic and stress system function, effects which are independent of a history of lifetime anxiety disorders.",2020,"Prazosin lowered basal cortisol and ACTH (p's<.05), and attenuated stress cue-induced rises in cortisol (p<.05) vs placebo.",['Forty inpatient treatment-seeking alcohol dependent individuals'],"['placebo', 'personalized guided imagery conditions (stress cue, alcohol cue, neutral/relaxing cue', 'prazosin', 'Prazosin']","['stress cue-induced alcohol craving and anxiety', ""basal cortisol and ACTH (p's<.05), and attenuated stress cue-induced rises in cortisol"", 'stress cue-induced alcohol craving (p<.05) and stress- and alcohol cue-induced anxiety (p<.05); and increased heart rate responses', 'stress-induced craving and improve neuroendocrine and autonomic response', 'Alcohol craving, anxiety, heart rate, cortisol and ACTH levels', 'stress- and alcohol cue-induced increases in cortisol', 'Provoked Alcohol Craving and Autonomic and Neuroendocrine Response']","[{'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0032912', 'cui_str': 'Prazosin'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0556385', 'cui_str': 'Craving for alcohol'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0001655', 'cui_str': 'Corticotropin'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0039231', 'cui_str': 'Tachycardia'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0027912', 'cui_str': 'Neuroendocrine System'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}]",,0.0290454,"Prazosin lowered basal cortisol and ACTH (p's<.05), and attenuated stress cue-induced rises in cortisol (p<.05) vs placebo.","[{'ForeName': 'Verica', 'Initials': 'V', 'LastName': 'Milivojevic', 'Affiliation': 'From the, Department of Psychiatry, (VM, GH, RS), The Yale Stress Center, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Gustavo A', 'Initials': 'GA', 'LastName': 'Angarita', 'Affiliation': 'Clinical Neuroscience Research Unit, (GAA), Department of Psychiatry, Connecticut Mental Health Center, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Gretchen', 'Initials': 'G', 'LastName': 'Hermes', 'Affiliation': 'From the, Department of Psychiatry, (VM, GH, RS), The Yale Stress Center, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Rajita', 'Initials': 'R', 'LastName': 'Sinha', 'Affiliation': 'From the, Department of Psychiatry, (VM, GH, RS), The Yale Stress Center, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Helen C', 'Initials': 'HC', 'LastName': 'Fox', 'Affiliation': 'Department of Psychiatry, (HCF), Stony Brook University School of Medicine, Stony Brook, New York.'}]","Alcoholism, clinical and experimental research",['10.1111/acer.14378']
1158,32451241,Economic benefit of a novel dual-mode ambulatory compression device for treatment of chronic venous leg ulcers in a randomized clinical trial.,"BACKGROUND


Limb compression is a key component of protocols used to heal venous leg ulcers (VLUs). A novel ambulatory pneumatic compression device was tested in comparison with multilayered bandage (MLB) compression systems for the treatment of VLUs in a prospective randomized clinical trial.
METHODS


Patients with VLUs measuring 1.5 to 50 cm 2  with duration of 1 to 24 months were randomized to treatment with a pneumatic compression device, the ACTitouch adaptive compression therapy (ACT) system (Tactile Medical, Minneapolis, Minn), or MLB. The ACT group patients were seen in the clinic at weeks 1, 2, 4, 6, 9, 12, and 16 or until wounds healed; the MLB group was seen weekly for bandage and dressing changes for 16 weeks or until wounds healed. All other aspects of VLU care were standardized between the two groups. The primary study objective was to compare the VLU percentage area reduction at 16 weeks in the ACT group compared with the MLB group.
RESULTS


There were 56 patients randomized to treatment with ACT (n = 26) or MLB (n = 30). In the ACT group, five patients exited because of skin or wound problems related to the ACT device and five withdrew because of the inconvenience of using the device. Therefore, the trial was halted before full randomization so improvements to the ACT device could be made. Data collected on 42 patients who were able to tolerate treatment for the 16-week study period (per protocol group) showed that both groups experienced similar rates of wound healing. In the per protocol population, the percentage area size reduction was greater for the ACT group compared with the MLB group (83.8% vs 70.5%, respectively), whereas no significant differences were noted in the percentage of wounds that healed by 16 weeks (60.0% vs 63.0%, respectively).
CONCLUSIONS


In this truncated clinical trial, a novel dual-mode ambulatory compression device, when tolerated, achieved wound healing results similar to those with MLB for chronic VLUs. The device requires modifications to improve the patient's comfort and ease of use. However, this mode of therapy appears to have promise for improving the cost-effectiveness of treatment for chronic VLUs.",2020,"In the per protocol population, the percentage area size reduction was greater for the ACT group compared with the MLB group (83.8% vs 70.5%, respectively), whereas no significant differences were noted in the percentage of wounds that healed by 16 weeks (60.0% vs 63.0%, respectively).
","['Patients with VLUs measuring 1.5 to 50\xa0cm 2  with duration of 1 to 24\xa0months', 'chronic venous leg ulcers', '42 patients who were able to tolerate treatment for the 16-week study period (per protocol group']","['multilayered bandage (MLB) compression systems', 'novel dual-mode ambulatory compression device', 'MLB', 'pneumatic compression device, the ACTitouch adaptive compression therapy (ACT) system (Tactile Medical, Minneapolis, Minn), or MLB', 'ambulatory pneumatic compression device', 'ACT']","['percentage area size reduction', 'skin or wound problems', 'percentage of wounds that healed', 'VLU percentage area reduction', 'rates of wound healing']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042344', 'cui_str': 'Stasis ulcer'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0004726', 'cui_str': 'Bandage'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439815', 'cui_str': 'Tactile'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}]",56.0,0.0704574,"In the per protocol population, the percentage area size reduction was greater for the ACT group compared with the MLB group (83.8% vs 70.5%, respectively), whereas no significant differences were noted in the percentage of wounds that healed by 16 weeks (60.0% vs 63.0%, respectively).
","[{'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Marston', 'Affiliation': 'Division of Vascular Surgery, University of North Carolina School of Medicine, Chapel Hill, NC. Electronic address: william_marston@med.unc.edu.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Kirsner', 'Affiliation': 'Department of Dermatology and Cutaneous Surgery, University of Miami Miller School of Medicine, Miami, Fla.'}, {'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'Tallis', 'Affiliation': 'Associated Foot & Ankle Specialists, LLC, Phoenix, Ariz.'}, {'ForeName': 'Jason R', 'Initials': 'JR', 'LastName': 'Hanft', 'Affiliation': 'The Foot & Ankle Institute, South Miami, Fla.'}, {'ForeName': 'Jodi', 'Initials': 'J', 'LastName': 'Walters', 'Affiliation': 'Arizona Regional Medical Research LLC, Tucson, Ariz.'}, {'ForeName': 'Alik', 'Initials': 'A', 'LastName': 'Farber', 'Affiliation': 'Departments of Surgery and Radiology, Boston University School of Medicine, Boston, Mass.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of vascular surgery. Venous and lymphatic disorders,['10.1016/j.jvsv.2020.03.004']
1159,32452275,A Novel Wearable Device for Motor Recovery of Hand Function in Chronic Stroke Survivors.,"Background.  In monkey, reticulospinal connections to hand and forearm muscles are spontaneously strengthened following corticospinal lesions, likely contributing to recovery of function. In healthy humans, pairing auditory clicks with electrical stimulation of a muscle induces plastic changes in motor pathways (probably including the reticulospinal tract), with features reminiscent of spike-timing dependent plasticity. In this study, we tested whether pairing clicks with muscle stimulation could improve hand function in chronic stroke survivors.  Methods.  Clicks were delivered via a miniature earpiece; transcutaneous electrical stimuli at motor threshold targeted forearm extensor muscles. A wearable electronic device (WD) allowed patients to receive stimulation at home while performing normal daily activities. A total of 95 patients >6 months poststroke were randomized to 3 groups: WD with shock paired 12 ms before click; WD with clicks and shocks delivered independently; standard care. Those allocated to the device used it for at least 4 h/d, every day for 4 weeks. Upper-limb function was assessed at baseline and weeks 2, 4, and 8 using the Action Research Arm Test (ARAT), which has 4 subdomains (Grasp, Grip, Pinch, and Gross).  Results.  Severity across the 3 groups was comparable at baseline. Only the paired stimulation group showed significant improvement in total ARAT (median baseline: 7.5; week 8: 11.5;  P  = .019) and the Grasp subscore (median baseline: 1; week 8: 4;  P  = .004).  Conclusion.  A wearable device delivering paired clicks and shocks over 4 weeks can produce a small but significant improvement in upper-limb function in stroke survivors.",2020,A wearable device delivering paired clicks and shocks over 4 weeks can produce a small but significant improvement in upper-limb function in stroke survivors.,"['chronic stroke survivors', '95 patients >6 months poststroke', 'Chronic Stroke Survivors']","['pairing clicks with muscle stimulation', 'shock paired 12 ms before click; WD with clicks and shocks delivered independently; standard care']","['Upper-limb function', 'Grasp subscore', 'upper-limb function', 'total ARAT']","[{'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0220843', 'cui_str': 'Grasp'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1264673', 'cui_str': 'Arbitrary rate'}]",95.0,0.0695364,A wearable device delivering paired clicks and shocks over 4 weeks can produce a small but significant improvement in upper-limb function in stroke survivors.,"[{'ForeName': 'Supriyo', 'Initials': 'S', 'LastName': 'Choudhury', 'Affiliation': 'Institute of Neurosciences, Kolkata, West Bengal, India.'}, {'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Singh', 'Affiliation': 'Institute of Neurosciences, Kolkata, West Bengal, India.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Shobhana', 'Affiliation': 'Institute of Neurosciences, Kolkata, West Bengal, India.'}, {'ForeName': 'Dwaipayan', 'Initials': 'D', 'LastName': 'Sen', 'Affiliation': 'Institute of Neurosciences, Kolkata, West Bengal, India.'}, {'ForeName': 'Sidharth Shankar', 'Initials': 'SS', 'LastName': 'Anand', 'Affiliation': 'Institute of Neurosciences, Kolkata, West Bengal, India.'}, {'ForeName': 'Shantanu', 'Initials': 'S', 'LastName': 'Shubham', 'Affiliation': 'Institute of Neurosciences, Kolkata, West Bengal, India.'}, {'ForeName': 'Suparna', 'Initials': 'S', 'LastName': 'Gangopadhyay', 'Affiliation': 'Institute of Neurosciences, Kolkata, West Bengal, India.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Baker', 'Affiliation': 'Newcastle University, Newcastle upon Tyne, Tyne and Wear, UK.'}, {'ForeName': 'Hrishikesh', 'Initials': 'H', 'LastName': 'Kumar', 'Affiliation': 'Institute of Neurosciences, Kolkata, West Bengal, India.'}, {'ForeName': 'Stuart N', 'Initials': 'SN', 'LastName': 'Baker', 'Affiliation': 'Newcastle University, Newcastle upon Tyne, Tyne and Wear, UK.'}]",Neurorehabilitation and neural repair,['10.1177/1545968320926162']
1160,32451321,Bioresorbable vascular scaffold versus metallic drug-eluting stent in patients at high risk of restenosis: the COMPARE-ABSORB randomised clinical trial.,"AIMS


The aim of this study was to investigate clinical outcomes of patients at high risk of restenosis after implantation of a bioresorbable vascular scaffold (BVS).
METHODS AND RESULTS


The COMPARE-ABSORB trial was an investigator-initiated, prospective randomised study. Patients at high risk of restenosis were randomly assigned to receive either a BVS or an everolimus-eluting stent (EES). A dedicated implantation technique was recommended for BVS. The primary endpoint was target lesion failure (TLF), defined as the composite of cardiac death, target vessel myocardial infarction (TVMI) or clinically indicated target lesion revascularisation at one year. The enrolment was discontinued prematurely because of a high thrombosis and TVMI rate in the BVS arm. A total of 1,670 patients were recruited (BVS 848 patients and EES 822 patients). TLF occurred in 43 patients (5.1%) of the BVS group and 34 patients (4.2%) of the EES group (absolute difference 0.9%, 95% confidence interval [CI]: -1.2%-3.0%, p non-inferiority <0.001). Definite or probable device thrombosis (2.0% vs 0.6%, hazard ratio [HR] 3.32, 95% CI: 1.22-8.99, p=0.012) and TVMI (4.0% vs 2.1%, HR 1.96, 95% CI: 1.10-3.51, p=0.02) were significantly higher in the BVS group than in the EES group.
CONCLUSIONS


In patients at high risk of restenosis, non-inferiority of BVS compared with EES in terms of TLF was met at one year. BVS carried a higher risk of device thrombosis and TVMI than EES.",2020,"Definite or probable device thrombosis (2.0% vs. 0.6%, hazard ratio 3.32, 95% CI 1.22 to 8.99, P=0.012) and TVMI (4.0% vs. 2.1%, hazard ratio 1.96, 95% CI 1.10 to 3.51, P=0.02) were significantly higher in the BVS group than the EES group.
","['1,670 patients were recruited (BVS 848 patients and EES 822 patients', 'Patients at High Risk of Restenosis', 'patients at high risk of restenosis after implantation of bioresorbable vascular scaffold (BVS', 'Patients at high risk of restenosis']","['Bioresorbable Vascular Scaffold Versus Metallic Drug-Eluting Stent', 'BVS or everolimus-eluting stent (EES']","['target lesion failure (TLF), defined as the composite of cardiac death, target vessel myocardial infarction (TVMI) or clinically-indicated target lesion revascularization', 'TLF', 'TVMI', 'thrombosis and TVMI rate', 'Definite or probable device thrombosis']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0337143', 'cui_str': 'Scaffold'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0333186', 'cui_str': 'Restenosis'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0337143', 'cui_str': 'Scaffold'}, {'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0038257', 'cui_str': 'Stent'}]","[{'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0449618', 'cui_str': 'Target vessel'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0439544', 'cui_str': 'Definite'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]",1670.0,0.283667,"Definite or probable device thrombosis (2.0% vs. 0.6%, hazard ratio 3.32, 95% CI 1.22 to 8.99, P=0.012) and TVMI (4.0% vs. 2.1%, hazard ratio 1.96, 95% CI 1.10 to 3.51, P=0.02) were significantly higher in the BVS group than the EES group.
","[{'ForeName': 'Pieter C', 'Initials': 'PC', 'LastName': 'Smits', 'Affiliation': 'Department of Cardiology, Maasstad Hospital, Rotterdam, the Netherlands.'}, {'ForeName': 'Chun Chin', 'Initials': 'CC', 'LastName': 'Chang', 'Affiliation': ''}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Chevalier', 'Affiliation': ''}, {'ForeName': 'Nick E J', 'Initials': 'NEJ', 'LastName': 'West', 'Affiliation': ''}, {'ForeName': 'Tommaso', 'Initials': 'T', 'LastName': 'Gori', 'Affiliation': ''}, {'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Barbato', 'Affiliation': ''}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Tarantini', 'Affiliation': ''}, {'ForeName': 'Viktor', 'Initials': 'V', 'LastName': 'Kocka', 'Affiliation': ''}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Achenbach', 'Affiliation': ''}, {'ForeName': 'Dariusz', 'Initials': 'D', 'LastName': 'Dudek', 'Affiliation': ''}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Escaned', 'Affiliation': ''}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Wlodarczak', 'Affiliation': ''}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Abdel-Wahab', 'Affiliation': ''}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Esposito', 'Affiliation': ''}, {'ForeName': 'Jan G P', 'Initials': 'JGP', 'LastName': 'Tijssen', 'Affiliation': ''}, {'ForeName': 'Marie-Claude', 'Initials': 'MC', 'LastName': 'Morice', 'Affiliation': ''}, {'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Onuma', 'Affiliation': ''}, {'ForeName': 'Robert-Jan M', 'Initials': 'RM', 'LastName': 'van Geuns', 'Affiliation': ''}]",EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology,['10.4244/EIJ-D-19-01079']
1161,32452561,Randomised clinical trial: standard of care versus early-transjugular intrahepatic porto-systemic shunt (TIPSS) in patients with cirrhosis and oesophageal variceal bleeding.,"BACKGROUND


Early-transjugular intrahepatic porto-systemic shunt (TIPSS) has been recommended in international guidelines for high-risk patients with oesophageal variceal bleeding.
AIM


To validate the results of a previous randomised control trial which supports use of early-TIPSS.
METHODS


In a two-centre open-label parallel-group randomised control trial, patients with cirrhosis and acute variceal bleeding were recruited following haemostasis with vaso-active drugs and endoscopic band ligation. Participants were randomised to standard of care or early-TIPSS. The primary outcome was 1-year survival, secondary outcomes included early and late rebleeding, and complications of portal hypertension.
RESULTS


Fifty-eight patients (58 ± 11.12 years; 32.7% female) were randomised. After one year, seven patients died in the standard of care group and six in the early-TIPSS group, a 1-year survival of 75.9% vs 79.3% respectively (P = 0.79). Variceal rebleeding occurred in eight patients in the standard of care group compared with three patients in the early-TIPSS group (P = 0.09). Not all participants randomised to early-TIPSS received the intervention in time. For those receiving TIPSS per-protocol, variceal rebleeding rates were reduced (0% vs 27.6%, P = 0.04) but this had no effect on survival (76.9% vs 75.9%, P = 0.91). Serious adverse events were similar in both treatment groups, except that rates of hepatic encephalopathy were higher in patients receiving TIPSS (46.1% vs 20.7%, P < 0.05).
CONCLUSIONS


Early-TIPSS reduced variceal rebleeding, increased encephalopathy but had no effect on survival in high-risk patients with oesophageal variceal bleeding. Early-TIPSS may not be feasible in many centres however, larger studies are needed. ClinicalTrials.gov reference: NCT02377141.",2020,"Serious adverse events were similar in both treatment groups, except that rates of hepatic encephalopathy were higher in patients receiving TIPSS (46.1% vs 20.7%, P < 0.05).
","['high-risk patients with oesophageal variceal bleeding', 'Fifty-eight patients (58\xa0±\xa011.12\xa0years; 32.7% female', 'patients with cirrhosis and acute variceal bleeding were recruited following', 'patients with cirrhosis and oesophageal variceal bleeding']","['transjugular intrahepatic porto-systemic shunt (TIPSS', 'standard of care or early-TIPSS', 'care versus early-transjugular intrahepatic porto-systemic shunt (TIPSS', 'haemostasis with vaso-active drugs and endoscopic band ligation']","['Variceal rebleeding', 'rates of hepatic encephalopathy', 'Serious adverse events', 'survival', 'variceal rebleeding, increased encephalopathy', 'variceal rebleeding rates', '1-year survival, secondary outcomes included early and late rebleeding, and complications of portal hypertension', '1-year survival']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0542331', 'cui_str': 'Shunt'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C0023690', 'cui_str': 'Ligation'}]","[{'cui': 'C0019151', 'cui_str': 'Hepatic encephalopathy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0085584', 'cui_str': 'Encephalopathy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0020541', 'cui_str': 'Portal hypertension'}]",58.0,0.414712,"Serious adverse events were similar in both treatment groups, except that rates of hepatic encephalopathy were higher in patients receiving TIPSS (46.1% vs 20.7%, P < 0.05).
","[{'ForeName': 'Philip D J', 'Initials': 'PDJ', 'LastName': 'Dunne', 'Affiliation': 'Liver Unit, Royal Infirmary of Edinburgh and University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Sinha', 'Affiliation': 'Liver Unit, Royal Infirmary of Edinburgh and University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Adrian J', 'Initials': 'AJ', 'LastName': 'Stanley', 'Affiliation': 'Department of Gastroenterology, Glasgow Royal Infirmary, Glasgow, UK.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Lachlan', 'Affiliation': 'Department of Gastroenterology, Glasgow Royal Infirmary, Glasgow, UK.'}, {'ForeName': 'Hamish', 'Initials': 'H', 'LastName': 'Ireland', 'Affiliation': 'Department of Radiology, Royal Infirmary of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Aman', 'Initials': 'A', 'LastName': 'Shams', 'Affiliation': 'Liver Unit, Royal Infirmary of Edinburgh and University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Ram', 'Initials': 'R', 'LastName': 'Kasthuri', 'Affiliation': 'Department of Radiology, Glasgow Royal Infirmary, Glasgow, UK.'}, {'ForeName': 'Ewan H', 'Initials': 'EH', 'LastName': 'Forrest', 'Affiliation': 'Department of Gastroenterology, Glasgow Royal Infirmary, Glasgow, UK.'}, {'ForeName': 'Peter C', 'Initials': 'PC', 'LastName': 'Hayes', 'Affiliation': 'Liver Unit, Royal Infirmary of Edinburgh and University of Edinburgh, Edinburgh, UK.'}]",Alimentary pharmacology & therapeutics,['10.1111/apt.15797']
1162,32454209,"Psilocybin acutely alters the functional connectivity of the claustrum with brain networks that support perception, memory, and attention.","Psychedelic drugs, including the serotonin 2a (5-HT 2A ) receptor partial agonist psilocybin, are receiving renewed attention for their possible efficacy in treating a variety of neuropsychiatric disorders. Psilocybin induces widespread dysregulation of cortical activity, but circuit-level mechanisms underlying this effect are unclear. The claustrum is a subcortical nucleus that highly expresses 5-HT 2A  receptors and provides glutamatergic inputs to arguably all areas of the cerebral cortex. We therefore tested the hypothesis that psilocybin modulates claustrum function in humans. Fifteen healthy participants (10M, 5F) completed this within-subjects study in which whole-brain resting-state blood-oxygenation level-dependent (BOLD) signal was measured 100 ​min after blinded oral administration of placebo and 10 mg/70 ​kg psilocybin. Left and right claustrum signal was isolated using small region confound correction. Psilocybin significantly decreased both the amplitude of low frequency fluctuations as well as the variance of BOLD signal in the left and right claustrum. Psilocybin also significantly decreased functional connectivity of the right claustrum with auditory and default mode networks (DMN), increased right claustrum connectivity with the fronto-parietal task control network (FPTC), and decreased left claustrum connectivity with the FPTC. DMN integrity was associated with right-claustrum connectivity with the DMN, while FPTC integrity and modularity were associated with right claustrum and left claustrum connectivity with the FPTC, respectively. Subjective effects of psilocybin predicted changes in the amplitude of low frequency fluctuations and the variance of BOLD signal in the left and right claustrum. Observed effects were specific to claustrum, compared to flanking regions of interest (the left and right insula and putamen). This study used a pharmacological intervention to provide the first empirical evidence in any species for a significant role of 5-HT 2A  receptor signaling in claustrum functioning, and supports a possible role of the claustrum in the subjective and therapeutic effects of psilocybin.",2020,Psilocybin significantly decreased both the amplitude of low frequency fluctuations as well as the variance of BOLD signal in the left and right claustrum.,"['Fifteen healthy participants (10M, 5F) completed this within-subjects study in which whole-brain resting-state blood-oxygenation level-dependent (BOLD) signal was measured 100\u202fmin after blinded oral administration of', 'humans']","['psilocybin', 'placebo and 10 mg/70\u202fkg psilocybin', 'Psilocybin', 'serotonin 2a (5-HT 2A ) receptor partial agonist psilocybin']","['BOLD signal', 'amplitude of low frequency fluctuations', 'functional connectivity of the right claustrum with auditory and default mode networks (DMN), increased right claustrum connectivity']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0001563', 'cui_str': 'Medication administration: oral'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0033850', 'cui_str': 'Psilocybine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0243192', 'cui_str': 'agonists'}]","[{'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C0231239', 'cui_str': 'Fluctuation'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0008910', 'cui_str': 'Claustral structure'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",15.0,0.0313229,Psilocybin significantly decreased both the amplitude of low frequency fluctuations as well as the variance of BOLD signal in the left and right claustrum.,"[{'ForeName': 'Frederick S', 'Initials': 'FS', 'LastName': 'Barrett', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, 21224, USA; Center for Psychedelic and Consciousness Research, Johns Hopkins University School of Medicine, Baltimore, MD, 21224, USA. Electronic address: fbarrett@jhmi.edu.'}, {'ForeName': 'Samuel R', 'Initials': 'SR', 'LastName': 'Krimmel', 'Affiliation': 'Department of Neural and Pain Sciences, School of Dentistry, and Center to Advance Chronic Pain Research, University of Maryland, Baltimore, MD, 21201, USA.'}, {'ForeName': 'Roland R', 'Initials': 'RR', 'LastName': 'Griffiths', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, 21224, USA; Center for Psychedelic and Consciousness Research, Johns Hopkins University School of Medicine, Baltimore, MD, 21224, USA; Department of Neuroscience, Johns Hopkins University School of Medicine, Baltimore, MD, 21224, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Seminowicz', 'Affiliation': 'Department of Neural and Pain Sciences, School of Dentistry, and Center to Advance Chronic Pain Research, University of Maryland, Baltimore, MD, 21201, USA.'}, {'ForeName': 'Brian N', 'Initials': 'BN', 'LastName': 'Mathur', 'Affiliation': 'Department of Pharmacology, School of Medicine, University of Maryland, Baltimore, MD, 21201, USA.'}]",NeuroImage,['10.1016/j.neuroimage.2020.116980']
1163,32459637,Evaluating Safety and Efficacy of Follow-up for Patients With Abdominal Pain Using Video Consultation (SAVED Study): Randomized Controlled Trial.,"BACKGROUND


The benefits of telemedicine include cost savings and decentralized care. Video consultation is one form that enables early detection of deteriorating patients and promotion of self-efficacy in patients who are well but anxious. Abdominal pain is a common symptom presented by patients in emergency departments. These patients could benefit from video consultation, as it enables remote follow-up of patients who do not require admission and facilitates early discharge of patients from overcrowded hospitals.
OBJECTIVE


The study aimed to evaluate the safety and efficacy of the use of digital telereview in patients presenting with undifferentiated acute abdominal pain.
METHODS


The SAVED study was a prospective randomized controlled trial in which follow-up using existing telephone-based telereview (control) was compared with digital telereview (intervention). Patients with undifferentiated acute abdominal pain discharged from the emergency department observation ward were studied based on intention-to-treat. The control arm received routine, provider-scheduled telereview with missed reviews actively coordinated and rescheduled by emergency department staff. The intervention arm received access to a platform for digital telereview (asynchronous and synchronous format) that enabled patient-led appointment rescheduling. Patients were followed-up for 2 weeks for outcomes of service utilization, efficacy (compliance with their disposition plan), and safety (re-presentation for the same condition).
RESULTS


A total of 70 patients participated, with patients randomly assigned to each arm (1:1 ratio). Patients were a mean age of 40.0 (SD 13.8; range 22-71) years, predominantly female (47/70, 67%), and predominantly of Chinese ethnicity (39/70, 56%). The telereview service was used by 32 patients in the control arm (32/35, 91%) and 18 patients in the intervention arm (18/35, 51%). Most patients in control (33/35, 94%; 95% CI 79.5%-99.0%) and intervention (34/35, 97%; 95% CI 83.4%-99.9%) arms were compliant with their final disposition. There was a low rate of re-presentation at 72 hours and 2 weeks for both control (72 hours: 2/35, 6%; 95% CI 1.0%-20.5%; 2 weeks: 2/35, 6%, 95% CI 1.0%-20.5%) and intervention (72 hours: 2/35, 6%; 95% CI 1.0%-20.5%; 2 weeks: 3/35, 9%, 95% CI 2.2%-24.2%) arms. There were no significant differences in safety (P>.99) and efficacy (P>.99) between the two groups.
CONCLUSIONS


The application of digital telereview for the follow-up of patients with abdominal pain may be safe and effective. Future studies are needed to evaluate its cost-effectiveness and usefulness for broader clinical application.
TRIAL REGISTRATION


ISRCTN Registry ISRCTN28468556; http://www.isrctn.com/ISRCTN28468556.",2020,"Most patients in control (33/35, 94%; 95% CI 79.5%-99.0%) and intervention (34/35, 97%; 95% CI 83.4%-99.9%) arms were compliant with their final disposition.","['strong>Methods</strong', 'CLINICALTRIAL\n\n\nSingHealth Singapore General Hospital (2017/2049', 'patients presenting with undifferentiated acute abdominal pain', 'Patients With Abdominal Pain Using Video Consultation', 'Patients were a mean age of 40.0 (SD 13.8; range 22-71) years, predominantly female (47/70, 67%), and predominantly of Chinese ethnicity (39/70, 56', '70 patients participated', 'Patients with undifferentiated acute abdominal pain discharged from the emergency department observation ward were studied based on intention-to-treat']","['existing telephone-based telereview (control', 'digital telereview (intervention', 'digital telereview', 'routine, provider-scheduled telereview with missed reviews actively coordinated and rescheduled by emergency department staff', 'access to a platform for digital telereview (asynchronous and synchronous format) that enabled patient-led appointment rescheduling']","['Safety and Efficacy', 'telereview service', 'safety', 'safety and efficacy', 'low rate of re-presentation', 'Abdominal pain', 'service utilization, efficacy (compliance with their disposition plan), and safety (re-presentation for the same condition', 'efficacy']","[{'cui': 'C0442821', 'cui_str': 'Strong'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205618', 'cui_str': 'Undifferentiated'}, {'cui': 'C0740577', 'cui_str': 'Acute abdominal pain'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517561', 'cui_str': '13.8'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0427184', 'cui_str': 'No incoordination'}, {'cui': 'C0205541', 'cui_str': 'Rescheduled'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0439581', 'cui_str': 'Asynchronous'}, {'cui': 'C0439580', 'cui_str': 'Synchronous'}, {'cui': 'C1301627', 'cui_str': 'Format'}, {'cui': 'C0562342', 'cui_str': 'Empowered'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C4704820', 'cui_str': 'Services Utilization'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",70.0,0.222931,"Most patients in control (33/35, 94%; 95% CI 79.5%-99.0%) and intervention (34/35, 97%; 95% CI 83.4%-99.9%) arms were compliant with their final disposition.","[{'ForeName': 'Dinesh Visva', 'Initials': 'DV', 'LastName': 'Gunasekeran', 'Affiliation': 'Department of Emergency Medicine, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Zhenghong', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Department of Emergency Medicine, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Win Jim', 'Initials': 'WJ', 'LastName': 'Tan', 'Affiliation': 'Department of Emergency Medicine, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Koh', 'Affiliation': 'Department of Emergency Medicine, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Chiu Peng', 'Initials': 'CP', 'LastName': 'Cheong', 'Affiliation': 'Department of Emergency Medicine, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Lay Hong', 'Initials': 'LH', 'LastName': 'Tan', 'Affiliation': 'Department of Emergency Medicine, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Chee Siang', 'Initials': 'CS', 'LastName': 'Lau', 'Affiliation': 'Department of Emergency Medicine, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Gaik Kheng', 'Initials': 'GK', 'LastName': 'Phuah', 'Affiliation': 'Department of Emergency Medicine, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Newsie Donnah A', 'Initials': 'NDA', 'LastName': 'Manuel', 'Affiliation': 'Department of Emergency Medicine, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Che Chong', 'Initials': 'CC', 'LastName': 'Chia', 'Affiliation': 'Department of Emergency Medicine, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Gek Siang', 'Initials': 'GS', 'LastName': 'Seng', 'Affiliation': 'Department of Emergency Medicine, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Tong', 'Affiliation': 'Department of Emergency Medicine, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'May Hang', 'Initials': 'MH', 'LastName': 'Huin', 'Affiliation': 'Department of Emergency Medicine, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Suzette Villaluna', 'Initials': 'SV', 'LastName': 'Dulce', 'Affiliation': 'Department of Emergency Medicine, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Yap', 'Affiliation': 'Department of Emergency Medicine, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Kishanti', 'Initials': 'K', 'LastName': 'Ponampalam', 'Affiliation': 'Department of Emergency Medicine, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Ying', 'Affiliation': 'Health Services Research Center, Singhealth Services, Singapore, Singapore.'}, {'ForeName': 'Marcus Eng Hock', 'Initials': 'MEH', 'LastName': 'Ong', 'Affiliation': 'Department of Emergency Medicine, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Ponampalam', 'Affiliation': 'Department of Emergency Medicine, Singapore General Hospital, Singapore, Singapore.'}]",Journal of medical Internet research,['10.2196/17417']
1164,32467641,The impact of high-intensity interval training (HIIT) and moderate-intensity continuous training (MICT) on arterial stiffness and blood pressure in young obese women: a randomized controlled trial.,,2020,,['young obese women'],['high-intensity interval training (HIIT) and moderate-intensity continuous training (MICT'],['arterial stiffness and blood pressure'],"[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]",,0.108794,,"[{'ForeName': 'Gustavo H', 'Initials': 'GH', 'LastName': 'de Oliveira', 'Affiliation': 'Department of Physical Education, Center of Health Sciences, State University of Maringa, Maringa, Brazil.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Boutouyrie', 'Affiliation': 'Department of Pharmacology, University Paris Descartes, Paris, France.'}, {'ForeName': 'Caroline F', 'Initials': 'CF', 'LastName': 'Simões', 'Affiliation': 'Department of Physical Education, Center of Health Sciences, State University of Maringa, Maringa, Brazil.'}, {'ForeName': 'João C', 'Initials': 'JC', 'LastName': 'Locatelli', 'Affiliation': 'Department of Physical Education, Center of Health Sciences, State University of Maringa, Maringa, Brazil.'}, {'ForeName': 'Victor H S', 'Initials': 'VHS', 'LastName': 'Mendes', 'Affiliation': 'Department of Physical Education, Center of Health Sciences, State University of Maringa, Maringa, Brazil.'}, {'ForeName': 'Higor B', 'Initials': 'HB', 'LastName': 'Reck', 'Affiliation': 'Department of Physical Education, Center of Health Sciences, State University of Maringa, Maringa, Brazil.'}, {'ForeName': 'Carla Eloise', 'Initials': 'CE', 'LastName': 'Costa', 'Affiliation': 'Department of Physical Education, Center of Health Sciences, State University of Maringa, Maringa, Brazil.'}, {'ForeName': 'Rogério T P', 'Initials': 'RTP', 'LastName': 'Okawa', 'Affiliation': 'Research Group on Systemic Arterial Hypertension, Arterial Stiffness and Vascular Aging (GPHARV), State University of Maringa, Maringa, Brazil.'}, {'ForeName': 'Wendell A', 'Initials': 'WA', 'LastName': 'Lopes', 'Affiliation': 'Department of Physical Education, Center of Health Sciences, State University of Maringa, Maringa, Brazil. warthurlopes@gmail.com.'}]",Hypertension research : official journal of the Japanese Society of Hypertension,['10.1038/s41440-020-0477-2']
1165,32468696,"Re: Mesh inlay, mesh kit or native tissue repair for women having repeat anterior or posterior prolapse surgery: randomised controlled trial (PROSPECT).",,2020,,['women having repeat anterior or posterior prolapse surgery'],"['Re: Mesh inlay, mesh kit or native tissue repair']",[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0021513', 'cui_str': 'Dental Inlays'}, {'cui': 'C0812225', 'cui_str': 'Device kit'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}]",[],,0.19633,,"[{'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Maher', 'Affiliation': ""Royal Brisbane and Women's Hospital, University of Queensland, Brisbane, QLD, Australia.""}, {'ForeName': 'Gunter', 'Initials': 'G', 'LastName': 'Hartel', 'Affiliation': 'Queensland Institute of Medical Research Berghofer Statistics Unit, Brisbane, QLD, Australia.'}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16301']
1166,32464260,"Methylphenidate as Needed for Fatigue in Patients With Advanced Cancer. A Prospective, Double-Blind, and Placebo-Controlled Study.","CONTEXT


Cancer-related fatigue is a highly prevalent symptom with a strong negative impact on patients' daily life.
OBJECTIVES


To evaluate the efficacy of methylphenidate as needed for the management of fatigue in patients with advanced cancer.
METHODS


A prospective, controlled, double-blind, and paired design, where the patient was her and/or his own control. Patients with advanced cancer with a tiredness score of ≥50 on a 0-100 visual analogue scale (VAS) were included. Patients were given 10 placebo and 10 methylphenidate tablets numbered 1-20 packed in blocks of four with two active and two placebo tablets (randomly arranged). Patients taking minimum three tablets were regarded evaluable. Primary effect parameters were mean differences in VAS for tiredness after two and five hours. With 28 evaluable patients, the study had a power of 0.90 to detect a mean difference of 15 between active and placebo.
RESULTS


Thirty-eight patients were enrolled to get 28 evaluable patients. Mean tiredness score before taking the tablets was 75 for placebo and 72 for methylphenidate on VAS (0-100). Mean changes (decrease) for methylphenidate after two and five hours were 20 and 17, respectively, and eight and five for placebo. Comparing mean differences, a significant decrease for methylphenidate compared with placebo was observed after two hours (P = 0.004) and five hours (P = 0.001), respectively.
CONCLUSION


In this controlled and double-blind study in patients with advanced cancer, methylphenidate as needed was significantly more effective than placebo in relieving fatigue after two and five hours.",2020,"Comparing mean differences, a significant decrease for methylphenidate compared to placebo was observed after two hours (p=0.004) and five hours (p=0.001), respectively.
","['Thirty-eight patients were enrolled to get 28 evaluable patients', 'Patients with advanced cancer with a tiredness score > 50 on a 0-100 visual analogue scale (VAS) were included', 'patients with advanced cancer']","['methylphenidate tablets', 'methylphenidate', 'Methylphenidate', 'placebo tablets', 'placebo']","['Mean tiredness score', 'relieving fatigue', 'VAS for tiredness']","[{'cui': 'C0450361', 'cui_str': '38'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332303', 'cui_str': 'Relieved by'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",38.0,0.380608,"Comparing mean differences, a significant decrease for methylphenidate compared to placebo was observed after two hours (p=0.004) and five hours (p=0.001), respectively.
","[{'ForeName': 'Lise', 'Initials': 'L', 'LastName': 'Pedersen', 'Affiliation': 'Department of Palliative Medicine, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Line', 'Initials': 'L', 'LastName': 'Lund', 'Affiliation': 'Department of Palliative Medicine, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark. Electronic address: line.lund.01@regionh.dk.'}, {'ForeName': 'Morten A', 'Initials': 'MA', 'LastName': 'Petersen', 'Affiliation': 'Department of Palliative Medicine, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Sjogren', 'Affiliation': 'Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark; Section of Palliative Medicine, Department of Oncology, Rigshospitalet - Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Mogens', 'Initials': 'M', 'LastName': 'Groenvold', 'Affiliation': 'Department of Palliative Medicine, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark; Section of Health Services Research, Department of Public Health, University of Copenhagen, Copenhagen, Denmark.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2020.05.023']
1167,32460725,"A two arm randomized controlled trial comparing the short and long term effects of an elimination diet and a healthy diet in children with ADHD (TRACE study). Rationale, study design and methods.","BACKGROUND


Food may trigger Attention-Deficit/Hyperactivity Disorder (ADHD) symptoms. Therefore, an elimination diet (ED) might be an effective treatment for children with ADHD. However, earlier studies were criticized for the nature of the control group, potential confounders explaining the observed effects, unsatisfactory blinding, potential risks of nutritional deficiencies and unknown long term and cost-effectiveness. To address these issues, this paper describes the rationale, study design and methods of an ongoing two arm randomized controlled trial (RCT) comparing the short (5 week) and long term (1 year) effects of an elimination diet and a healthy diet compared with care as usual (CAU) in children with ADHD.
METHODS


A total of N = 162 children (5-12 years) with ADHD will be randomized to either an ED or a healthy diet. A comparator arm including N = 60 children being solely treated with CAU (e.g. medication) is used to compare the effects found in both dietary groups. The two armed RCT is performed in two youth psychiatry centers in the Netherlands, with randomization within each participating center. The primary outcome measure is response to treatment defined as a ≥ 30% reduction on an ADHD DSM-5 rating scale (SWAN) and/or on an emotion dysregulation rating scale (SDQ: dysregulation profile). This is assessed after 5 weeks of dietary treatment, after which participants continue the diet or not. Secondary outcome measures include the Disruptive Behavior Diagnostic Observational Schedule (DB-DOS), parent and teacher ratings of comorbid symptoms, cognitive assessment (e.g. executive functions), school functioning, physical measurements (e.g. weight), motor activity, sleep pattern, food consumption, nutritional quality of the diet, adherence, parental wellbeing, use of health care resources and cost-effectiveness. Assessments take place at the start of the study (T0), after five weeks (T1), four months (T2), eight months (T3) and 12 months of treatment (T4). T0, T1 and T4 assessments take place at one of the psychiatric centers. T2 and T3 assessments consist of filling out online questionnaires by the parents only.
DISCUSSION


This RCT will likely contribute significantly to clinical practice for ADHD by offering insight into the feasibility, nutritional quality, (cost-)effectiveness and long term effects of dietary treatments for ADHD.
TRIAL REGISTRATION


www.trialregister.nl, NTR5434. Registered at October 11th, 2015.",2020,A total of N = 162 children (5-12 years) with ADHD will be randomized to either an ED or a healthy diet.,"['children with ADHD', 'children with ADHD (TRACE study', 'two youth psychiatry centers in the Netherlands, with randomization within each participating center', 'A total of N\u2009=\u2009162 children (5-12\u2009years) with ADHD']","['elimination diet and a healthy diet', 'elimination diet and a healthy diet compared with care as usual (CAU', 'CAU (e.g. medication']","['response to treatment defined as a\u2009≥\u200930% reduction on an ADHD DSM-5 rating scale (SWAN) and/or on an emotion dysregulation rating scale (SDQ: dysregulation profile', 'Disruptive Behavior Diagnostic Observational Schedule (DB-DOS), parent and teacher ratings of comorbid symptoms, cognitive assessment (e.g. executive functions), school functioning, physical measurements (e.g. weight), motor activity, sleep pattern, food consumption, nutritional quality of the diet, adherence, parental wellbeing, use of health care resources and cost-effectiveness']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0442822', 'cui_str': 'Trace'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C5191360', 'cui_str': '162'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0452376', 'cui_str': 'Elimination diet'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0521982', 'cui_str': 'Response to treatment'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0474416', 'cui_str': 'Disruptive behavior'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1518527', 'cui_str': 'Observational Study'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0474396', 'cui_str': 'Sleep behavior finding'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C3489446', 'cui_str': 'Nutritive Quality'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.0521246,A total of N = 162 children (5-12 years) with ADHD will be randomized to either an ED or a healthy diet.,"[{'ForeName': 'Annick', 'Initials': 'A', 'LastName': 'Bosch', 'Affiliation': 'Karakter, Child and Adolescent Psychiatry, Reinier Postlaan 12, 6525, GC, Nijmegen, the Netherlands. a.bosch@karakter.com.'}, {'ForeName': 'Margreet', 'Initials': 'M', 'LastName': 'Bierens', 'Affiliation': 'Karakter, Child and Adolescent Psychiatry, Reinier Postlaan 12, 6525, GC, Nijmegen, the Netherlands.'}, {'ForeName': 'Ardine G', 'Initials': 'AG', 'LastName': 'de Wit', 'Affiliation': 'National Institute for Public Health and the Environment (RIVM), Bilthoven, the Netherlands.'}, {'ForeName': 'Verena', 'Initials': 'V', 'LastName': 'Ly', 'Affiliation': 'Leiden University, Institute of Psychology and Leiden Institute for Brain and Cognition, Leiden, The Netherlands.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'van der Velde', 'Affiliation': 'Karakter, Child and Adolescent Psychiatry, Reinier Postlaan 12, 6525, GC, Nijmegen, the Netherlands.'}, {'ForeName': 'Heleen', 'Initials': 'H', 'LastName': 'de Boer', 'Affiliation': 'Accare, Child and Adolescent Psychiatry, Groningen, the Netherlands.'}, {'ForeName': 'Gerry', 'Initials': 'G', 'LastName': 'van Beek', 'Affiliation': 'Karakter, Child and Adolescent Psychiatry, Reinier Postlaan 12, 6525, GC, Nijmegen, the Netherlands.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Appelman', 'Affiliation': 'Triversum - GGZ-NHN, Child and Adolescent Psychiatry, Alkmaar, the Netherlands.'}, {'ForeName': 'Sacha', 'Initials': 'S', 'LastName': 'Visser', 'Affiliation': 'Freelance dietician, Velp, the Netherlands.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Bos', 'Affiliation': 'Karakter, Child and Adolescent Psychiatry, Reinier Postlaan 12, 6525, GC, Nijmegen, the Netherlands.'}, {'ForeName': 'Jolanda', 'Initials': 'J', 'LastName': 'van der Meer', 'Affiliation': 'De Bascule, Center for Child and Adolescent Psychiatry, Amsterdam, The Netherlands.'}, {'ForeName': 'Niki', 'Initials': 'N', 'LastName': 'Kamphuis', 'Affiliation': 'Karakter, Child and Adolescent Psychiatry, Reinier Postlaan 12, 6525, GC, Nijmegen, the Netherlands.'}, {'ForeName': 'Jos M T', 'Initials': 'JMT', 'LastName': 'Draaisma', 'Affiliation': ""Department of Pediatrics, Radboud University Medical Center Amalia Children's hospital, Nijmegen, the Netherlands.""}, {'ForeName': 'Rogier', 'Initials': 'R', 'LastName': 'Donders', 'Affiliation': 'Department for Health Evidence, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Gigi H H', 'Initials': 'GHH', 'LastName': 'van de Loo-Neus', 'Affiliation': 'Karakter, Child and Adolescent Psychiatry, Reinier Postlaan 12, 6525, GC, Nijmegen, the Netherlands.'}, {'ForeName': 'Pieter J', 'Initials': 'PJ', 'LastName': 'Hoekstra', 'Affiliation': 'Department of Child and Adolescent Psychiatry, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Bottelier', 'Affiliation': 'Triversum - GGZ-NHN, Child and Adolescent Psychiatry, Alkmaar, the Netherlands.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Arias-Vasquez', 'Affiliation': 'Department of Psychiatry, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Klip', 'Affiliation': 'Karakter, Child and Adolescent Psychiatry, Reinier Postlaan 12, 6525, GC, Nijmegen, the Netherlands.'}, {'ForeName': 'Jan K', 'Initials': 'JK', 'LastName': 'Buitelaar', 'Affiliation': 'Karakter, Child and Adolescent Psychiatry, Reinier Postlaan 12, 6525, GC, Nijmegen, the Netherlands.'}, {'ForeName': 'Saskia W', 'Initials': 'SW', 'LastName': 'van den Berg', 'Affiliation': 'National Institute for Public Health and the Environment (RIVM), Bilthoven, the Netherlands.'}, {'ForeName': 'Nanda N', 'Initials': 'NN', 'LastName': 'Rommelse', 'Affiliation': 'Karakter, Child and Adolescent Psychiatry, Reinier Postlaan 12, 6525, GC, Nijmegen, the Netherlands.'}]",BMC psychiatry,['10.1186/s12888-020-02576-2']
1168,32466496,Dance Fitness Classes Improve the Health-Related Quality of Life in Sedentary Women.,"This study aims to analyze the effect of two dance-focused and choreographic fitness classes on Health-Related Quality of Life (HRQoL) in sedentary worker women.  Methods :  65 sedentary middle-aged worker women (38 ± 7.3 years old) completed a 16-week intervention randomly assigned to: (1) dance fitness group based on Zumba Fitness classes (DF group,  n  = 25)], (2) dance fitness + functional strength training group (DFFT group,  n  = 20), and (3) control group ( n  = 20). HRQoL was assessed by the 36-Item Short-Form Health-Survey (SF-36), which evaluates 8 dimensions of health [General Health (GH), Physical Functioning (PF), Social Functioning (SF), Physical Role (PR), Emotional Role (ER), Bodily Pain (BP), Vitality (V), and Mental Health (MH)] scored from 0 (worst) to 100 (best health status).  Results : The control group statistically differed from both exercise groups in PF and PR, and from the DF group in SF and MH showing a lower score. No statistical differences were observed between exercise groups post-intervention, except in V. DF group showed increases in GH, PF, SF, V, PR, and MH post-intervention.  Conclusion : A 16-week dance fitness intervention based on Zumba Fitness classes generates notable improvements in a wide range of HRQoL dimensions in sedentary middle-aged worker women, especially in V, PR and MH dimensions.",2020,"The control group statistically differed from both exercise groups in PF and PR, and from the DF group in SF and MH showing a lower score.","['sedentary middle-aged worker women', '65 sedentary middle-aged worker women (38 ± 7.3 years old', 'Sedentary Women', 'sedentary worker women']","['dance fitness group based on Zumba Fitness classes (DF group,  n  = 25)], (2) dance fitness + functional strength training group (DFFT group,  n  = 20), and (3) control group']","['Health-Related Quality of Life (HRQoL', 'HRQoL', 'health [General Health (GH), Physical Functioning (PF), Social Functioning (SF), Physical Role (PR), Emotional Role (ER), Bodily Pain (BP), Vitality (V), and Mental Health (MH)] scored from 0 (worst) to 100 (best health status', 'GH, PF, SF, V, PR, and MH post-intervention', 'Health-Related Quality of Life', 'HRQoL dimensions']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0010963', 'cui_str': 'Dance'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}]",65.0,0.0337697,"The control group statistically differed from both exercise groups in PF and PR, and from the DF group in SF and MH showing a lower score.","[{'ForeName': 'Yaira', 'Initials': 'Y', 'LastName': 'Barranco-Ruiz', 'Affiliation': 'Department of Physical Education and Sports, PROFITH ""PROmoting FITness and Health through physical activity"" Research Group, Sport and Health University Research Institute (iMUDS), Faculty of Education and Sport Sciences, University of Granada, 52071 Melilla, Spain.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Paz-Viteri', 'Affiliation': 'Pedagogy School of Physical Activity and Sports, Faculty of Education Sciences, National University of Chimborazo, 060150 Riobamba, Ecuador.'}, {'ForeName': 'Emilio', 'Initials': 'E', 'LastName': 'Villa-González', 'Affiliation': 'Department of Physical Education and Sports, PROFITH ""PROmoting FITness and Health through physical activity"" Research Group, Sport and Health University Research Institute (iMUDS), Faculty of Education and Sport Sciences, University of Granada, 52071 Melilla, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17113771']
1169,32466588,"Effect of Neuromuscular Electrical Stimulation on Masseter Muscle Thickness and Maximal Bite Force Among Healthy Community-Dwelling Persons Aged 65 Years and Older: A Randomized, Double Blind, Placebo-Controlled Study.","AIM


This study investigated the effect of neuromuscular electrical stimulation (NMES) on masseter muscle thickness and maximal bite force among healthy community-dwelling elderly persons older than 65 years.
MATERIALS AND METHODS


A total of 40 participants were randomly assigned to the experimental and placebo groups. In the experimental group, NMES was applied to both masseter muscles, and electrical signals were gradually increased until the participants felt a grabbing sensation (range 6.0-7.5 mA) in the masseter muscle. The placebo group, in contrast, underwent NMES in the same manner and procedure as the experimental group with less electrical intensity (0.5 mA). All interventions were administered five times a week for six weeks, 20 min per day. The outcomes were masseter muscle thickness assessed using ultrasound and maximal bite force using a bite force meter. The level of significance was set as  p  < 0.05.
RESULTS


The experimental group showed a significant increase in both masseter muscle thickness and maximal bite force as compared with the placebo group (p = 0.002 and 0.019, respectively). Moreover, the degree of change in the masseter muscle thickness and maximal bite force significantly increased in the experimental and placebo groups (p < 0.001, both).
CONCLUSIONS


This study demonstrated that NMES could be an effective modality for increasing masseter muscle thickness and maximal bite force in healthy older adults.",2020,"The experimental group showed a significant increase in both masseter muscle thickness and maximal bite force as compared with the placebo group (p = 0.002 and 0.019, respectively).","['A total of 40 participants', 'healthy community-dwelling elderly persons older than 65 years', 'Aged 65 Years and Older', 'Healthy Community-Dwelling Persons', 'healthy older adults']","['Placebo', 'NMES', 'neuromuscular electrical stimulation (NMES', 'Neuromuscular Electrical Stimulation', 'placebo']","['electrical intensity', 'Masseter Muscle Thickness and Maximal Bite Force', 'masseter muscle thickness assessed using ultrasound and maximal bite force using a bite force meter', 'masseter muscle thickness and maximal bite force']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}]","[{'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0024876', 'cui_str': 'Masseter muscle structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0005654', 'cui_str': 'Masticatory Force'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0441074', 'cui_str': 'Meters'}]",40.0,0.200011,"The experimental group showed a significant increase in both masseter muscle thickness and maximal bite force as compared with the placebo group (p = 0.002 and 0.019, respectively).","[{'ForeName': 'Moon-Young', 'Initials': 'MY', 'LastName': 'Chang', 'Affiliation': 'Department of Occupational Therapy, Inje University, Gimhae 50834, Korea.'}, {'ForeName': 'Gihyoun', 'Initials': 'G', 'LastName': 'Lee', 'Affiliation': 'Department of Physical and Rehabilitation Medicine, Center for Prevention and Rehabilitation, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul 06351, Korea.'}, {'ForeName': 'Young-Jin', 'Initials': 'YJ', 'LastName': 'Jung', 'Affiliation': 'Department of Radiological Science, Health Sciences Division, Dongseo University, Busan 47011, Korea.'}, {'ForeName': 'Ji-Su', 'Initials': 'JS', 'LastName': 'Park', 'Affiliation': 'Advanced Human Resource Development Project Group for Health Care in Aging Friendly Industry, Dongseo University, Busan 47011, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17113783']
1170,32466710,Effects of acute alcohol consumption on emotion recognition in high and low trait aggressive drinkers.,"BACKGROUND


Research suggests that acute alcohol consumption impairs processing of emotional faces. As emotion processing plays a key role in effective social interaction, these impairments may be one mechanism by which alcohol changes social behaviour. This study investigated the effect of individual differences on this relationship by comparing emotion recognition performance after acute alcohol consumption in individuals with high and low trait aggression.
METHODS


Regular non-dependent drinkers, either high or low in trait aggression participated in a double-blind placebo-controlled experiment ( N  = 88, 50% high trait aggressive). Participants attended two sessions. In one they consumed an alcoholic drink (0.4 g/kg) and in the other they consumed a matched placebo. They then completed two computer-based tasks: one measured global and emotion-specific recognition performance across six primary emotions (anger, sadness, happiness, disgust, fear, surprise), the other measured processing bias of two ambiguously expressive faces (happy-angry/happy-sad).
RESULTS


There was evidence of poorer global emotion recognition after alcohol. In addition, there was evidence of poorer sensitivity to sadness and fear after alcohol. There was also evidence for a reduced bias towards happiness following alcohol and weak evidence for an increased bias towards sadness.
CONCLUSIONS


These findings suggest that alcohol impairs global emotion recognition. They also highlight a reduced ability to detect sadness and fearful facial expressions. As sadness and fear are cues of submission and distress (i.e. function to curtail aggression), failure to successfully detect these emotions when intoxicated may increase the likelihood of aggressive responding. This coupled with a reduced bias towards seeing happiness may collectively contribute to aggressive behaviour.",2020,There was evidence of poorer global emotion recognition after alcohol.,"['individuals with high and low trait aggression', 'Regular non-dependent drinkers, either high or low in trait aggression participated in a double-blind placebo-controlled experiment ( N  = 88, 50% high trait aggressive', 'high and low trait aggressive drinkers']","['acute alcohol consumption', 'alcoholic drink', 'placebo']","['poorer global emotion recognition', 'global and emotion-specific recognition performance across six primary emotions (anger, sadness, happiness, disgust, fear, surprise), the other measured processing bias of two ambiguously expressive faces (happy-angry/happy-sad', 'global emotion recognition', 'emotion recognition', 'emotion recognition performance']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0687725', 'cui_str': 'Problem drinker'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C3536794', 'cui_str': 'Unhappiness'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0683283', 'cui_str': 'Disgust'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0085159', 'cui_str': 'Seasonal affective disorder'}]",,0.189109,There was evidence of poorer global emotion recognition after alcohol.,"[{'ForeName': 'Andrew Pr', 'Initials': 'AP', 'LastName': 'Eastwood', 'Affiliation': 'MRC Integrative Epidemiology Unit at the University of Bristol, Bristol, UK.'}, {'ForeName': 'Ian S', 'Initials': 'IS', 'LastName': 'Penton-Voak', 'Affiliation': 'UK Centre for Tobacco and Alcohol Studies, School of Psychological Science, University of Bristol, Bristol, UK.'}, {'ForeName': 'Marcus R', 'Initials': 'MR', 'LastName': 'Munafò', 'Affiliation': 'MRC Integrative Epidemiology Unit at the University of Bristol, Bristol, UK.'}, {'ForeName': 'Angela S', 'Initials': 'AS', 'LastName': 'Attwood', 'Affiliation': 'MRC Integrative Epidemiology Unit at the University of Bristol, Bristol, UK.'}]","Journal of psychopharmacology (Oxford, England)",['10.1177/0269881120922951']
1171,32467323,"Thrombolysis with alteplase 3-4.5 hours after acute ischaemic stroke: the first multicentre, phase III trial in China.","BACKGROUND AND PURPOSE


Data on the efficacy and safety of alteplase for acute ischaemic stroke (AIS) administered 3-4.5 hours after the onset of stroke symptoms in Chinese patients is limited. We sought to determine whether AIS patients would benefit from thrombolysis with alteplase between 3 and 4.5 hours after the onset of stroke symptoms in a prospective, multicentre, single-arm trial in China.
MATERIALS AND METHODS


Eligible AIS patients were given 0.9 mg/kg alteplase intravenously. The primary efficacy endpoint was a favourable outcome at 3 months, defined as a score of 0 or 1 on the modified Rankin Scale. Thresholds for the primary efficacy endpoint were determined to be 40% based on the literature review. The primary safety endpoint was symptomatic intracranial haemorrhage (sICH) according to the European Cooperative Acute Stroke Study III (ECASS III) trial definition. Post hoc analysis between this study and the ECASS III trial were compared using the propensity score matching (PSM) method.
RESULTS


A total of 120 eligible AIS patients from 11 sites in China received thrombolysis therapy in this study. The median time from onset of symptoms to needle was 3 hours 54 min. The percentage of patients with a favourable outcome was 63.3% (95% CI 54.4 to 71.4), significantly higher than the predefined threshold (p<0.0001). Three patients (2.5%, 95% CI 0.5 to 7.1) had sICH, including two fatal sICH. Six patients died within 3 months after treatment. The post hoc PSM analysis showed a numerically higher rate of the primary efficacy endpoint in this study (63.3%) than the matched placebo arm (56.7%) in the ECASS III trial.
CONCLUSIONS


Intravenous alteplase with a standard dose administered between 3 and 4.5 hours after onset of symptoms is effective and safe for Chinese AIS patients.
TRIAL REGISTRATION NUMBER


NCT02930837.",2020,"The post hoc PSM analysis showed a numerically higher rate of the primary efficacy endpoint in this study (63.3%) than the matched placebo arm (56.7%) in the ECASS III trial.
","['120 eligible AIS patients from 11 sites in China received thrombolysis therapy in this study', 'Chinese AIS patients', 'Chinese patients', 'Eligible AIS patients']","['alteplase', 'Intravenous alteplase', 'placebo']","['symptomatic intracranial haemorrhage (sICH', 'favourable outcome at 3 months, defined as a score of 0 or 1 on the modified Rankin Scale', 'median time from onset of symptoms to needle']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}]","[{'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0151699', 'cui_str': 'Intracranial hemorrhage'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}]",120.0,0.198498,"The post hoc PSM analysis showed a numerically higher rate of the primary efficacy endpoint in this study (63.3%) than the matched placebo arm (56.7%) in the ECASS III trial.
","[{'ForeName': 'Huaguang', 'Initials': 'H', 'LastName': 'Zheng', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Affiliated Capital Medical University, Beijing, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Neurology, The First Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Huisheng', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Neurology, General Hospital of Northern Theater Command, Shenyang, China.'}, {'ForeName': 'Chuanling', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Department of Neurology, Xuzhou Central Hospital, Xuzhou, China.'}, {'ForeName': 'Yangkun', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': ""Neurology, Dongguan People's Hospital, Dongguan, China.""}, {'ForeName': 'Fu-Dong', 'Initials': 'FD', 'LastName': 'Shi', 'Affiliation': 'Department of Neurology, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Department of Neurology, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Xiaoping', 'Initials': 'X', 'LastName': 'Cui', 'Affiliation': 'Department of Neurology, No.900 Hospital of Joint Logistics Support Force, Fuzhou, China.'}, {'ForeName': 'Zuneng', 'Initials': 'Z', 'LastName': 'Lu', 'Affiliation': 'Department of Neurology, Renmin Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Yanling', 'Initials': 'Y', 'LastName': 'Liang', 'Affiliation': 'Department of Neurology, The Third Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Songbiao', 'Initials': 'S', 'LastName': 'Cui', 'Affiliation': 'Department of Neurology, Yanbian University Hospital, Yanji, China.'}, {'ForeName': 'Anding', 'Initials': 'A', 'LastName': 'Xu', 'Affiliation': 'Neurology, The First Affiliated Hospital of Jinan University, Guangzhou, Guangdong Province, China.'}, {'ForeName': 'Yiqing', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Boehringer Ingelheim (China) Investment Co., Ltd, Shanghai, China.'}, {'ForeName': 'Yaqing', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Boehringer Ingelheim (China) Investment Co., Ltd, Shanghai, China.'}, {'ForeName': 'Yongjun', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Affiliated Capital Medical University, Beijing, China yongjunwang@ncrcnd.org.cn.'}]",Stroke and vascular neurology,['10.1136/svn-2020-000337']
1172,32472620,Acute Alcohol Intake Produces Widespread Decreases in Cortical Resting Signal Variability in Healthy Social Drinkers.,"BACKGROUND


Acute alcohol intoxication has wide-ranging neurobehavioral effects on psychomotor, attentional, inhibitory, and memory-related cognitive processes. These effects are mirrored in disruption of neural metabolism, functional activation, and functional network coherence. Metrics of intraregional neural dynamics such as regional signal variability (RSV) and brain entropy (BEN) may capture unique aspects of neural functional capacity in healthy and clinical populations; however, alcohol's influence on these metrics is unclear. The present study aimed to elucidate the influence of acute alcohol intoxication on RSV and to clarify these effects with subsequent BEN analyses.
METHODS


26 healthy adults between 25 and 45 years of age (65.4% women) participated in 2 counterbalanced sessions. In one, participants consumed a beverage containing alcohol sufficient to produce a breath alcohol concentration of 0.08 g/dl. In the other, they consumed a placebo beverage. Approximately 35 minutes after beverage consumption, participants completed a 9-minute resting-state fMRI scan. Whole-brain, voxel-wise standard deviation was used to assess RSV, which was compared between sessions. Within clusters displaying alterations in RSV, sample entropy was calculated to assess BEN.
RESULTS


Compared to the placebo, alcohol intake resulted in widespread reductions in RSV in the bilateral middle frontal, right inferior frontal, right superior frontal, bilateral posterior cingulate, bilateral middle temporal, right supramarginal gyri, and bilateral inferior parietal lobule. Within these clusters, significant reductions in BEN were found in the bilateral middle frontal and right superior frontal gyri. No effects were noted in subcortical or cerebellar areas.
CONCLUSIONS


Findings indicate that alcohol intake produces diffuse reductions in RSV among structures associated with attentional processes. Within these structures, signal complexity was also reduced in a subset of frontal regions. Neurobehavioral effects of acute alcohol consumption may be partially driven by disruption of intraregional neural dynamics among regions involved in higher-order cognitive and attentional processes.",2020,"Compared to the placebo, alcohol intake resulted in widespread reductions in RSV in the bilateral middle frontal, right inferior frontal, right superior frontal, bilateral posterior cingulate, bilateral middle temporal, right supramarginal gyri, and bilateral inferior parietal lobule.","['Healthy Social Drinkers', 'healthy and clinical populations', '26 healthy adults between 25 and 45 years of age (65.4% women']","['placebo beverage', 'placebo, alcohol intake']","['BEN', 'disruption of neural metabolism, functional activation, and functional network coherence', 'subcortical or cerebellar areas', 'bilateral middle frontal, right inferior frontal, right superior frontal, bilateral posterior cingulate, bilateral middle temporal, right supramarginal gyri, and bilateral inferior parietal lobule']","[{'cui': 'C0337676', 'cui_str': 'Social drinker'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}]","[{'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0376522', 'cui_str': 'Entropy'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0007765', 'cui_str': 'Cerebellar structure'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0175191', 'cui_str': 'Posterior Cingulate Gyri'}, {'cui': 'C0442043', 'cui_str': 'Temporal'}, {'cui': 'C0152304', 'cui_str': 'Inferior parietal lobule structure'}]",26.0,0.111513,"Compared to the placebo, alcohol intake resulted in widespread reductions in RSV in the bilateral middle frontal, right inferior frontal, right superior frontal, bilateral posterior cingulate, bilateral middle temporal, right supramarginal gyri, and bilateral inferior parietal lobule.","[{'ForeName': 'Landrew', 'Initials': 'L', 'LastName': 'Sevel', 'Affiliation': 'From the Osher Center for Integrative Medicine at Vanderbilt, Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Bethany', 'Initials': 'B', 'LastName': 'Stennett', 'Affiliation': 'Center for Pain Research and Behavioral Health, University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Schneider', 'Affiliation': 'Center for Pain Research and Behavioral Health, University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Bush', 'Affiliation': 'Center for Pain Research and Behavioral Health, University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'Sara Jo', 'Initials': 'SJ', 'LastName': 'Nixon', 'Affiliation': 'Department of Psychiatry, University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Robinson', 'Affiliation': 'Center for Pain Research and Behavioral Health, University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Boissoneault', 'Affiliation': 'Center for Pain Research and Behavioral Health, University of Florida, Gainesville, Florida, USA.'}]","Alcoholism, clinical and experimental research",['10.1111/acer.14381']
1173,32470981,Energy Requirement Is Higher During Weight-Loss Maintenance in Adults Consuming a Low- Compared with High-Carbohydrate Diet.,"BACKGROUND


Longer-term feeding studies suggest that a low-carbohydrate diet increases energy expenditure, consistent with the carbohydrate-insulin model of obesity. However, the validity of methodology utilized in these studies, involving doubly labeled water (DLW), has been questioned.
OBJECTIVE


The aim of this study was to determine whether dietary energy requirement for weight-loss maintenance is higher on a low- compared with high-carbohydrate diet.
METHODS


The study reports secondary outcomes from a feeding study in which the primary outcome was total energy expenditure (TEE). After attaining a mean Run-in weight loss of 10.5%, 164 adults (BMI ≥25 kg/m2; 70.1% women) were randomly assigned to Low-Carbohydrate (percentage of total energy from carbohydrate, fat, protein: 20/60/20), Moderate-Carbohydrate (40/40/20), or High-Carbohydrate (60/20/20) Test diets for 20 wk. Calorie content was adjusted to maintain individual body weight within ± 2 kg of the postweight-loss value. In analyses by intention-to-treat (ITT, completers, n = 148) and per protocol (PP, completers also achieving weight-loss maintenance, n = 110), we compared the estimated energy requirement (EER) from 10 to 20 wk of the Test diets using ANCOVA.
RESULTS


Mean EER was higher in the Low- versus High-Carbohydrate group in models of varying covariate structure involving ITT [ranging from 181 (95% CI: 8-353) to 246 (64-427) kcal/d; P ≤0.04] and PP [ranging from 245 (43-446) to 323 (122-525) kcal/d; P ≤0.02]. This difference remained significant in sensitivity analyses accounting for change in adiposity and possible nonadherence.
CONCLUSIONS


Energy requirement was higher on a low- versus high-carbohydrate diet during weight-loss maintenance in adults, commensurate with TEE. These data are consistent with the carbohydrate-insulin model and lend qualified support for the validity of the DLW method with diets varying in macronutrient composition. This trial was registered at clinicaltrials.gov as NCT02068885.",2020,Mean EER was higher in the Low- versus High-Carbohydrate group in models of varying covariate structure involving ITT [ranging from 181 (95% CI: 8-353) to 246 (64-427) kcal/d; P ≤0.04] and PP [ranging from 245 (43-446) to 323,"['164 adults (BMI\xa0≥25 kg/m2; 70.1% women', 'Adults Consuming a Low- Compared with High-Carbohydrate Diet']","['Moderate-Carbohydrate (40/40/20), or High-Carbohydrate (60/20/20) Test diets']","['weight-loss maintenance', 'total energy expenditure (TEE', 'Mean EER']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0259835', 'cui_str': 'High carbohydrate diet'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0452401', 'cui_str': 'Test diet'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0429629', 'cui_str': 'Total energy expenditure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0489460', 'cui_str': 'Energy requirement'}]",,0.136023,Mean EER was higher in the Low- versus High-Carbohydrate group in models of varying covariate structure involving ITT [ranging from 181 (95% CI: 8-353) to 246 (64-427) kcal/d; P ≤0.04] and PP [ranging from 245 (43-446) to 323,"[{'ForeName': 'Cara B', 'Initials': 'CB', 'LastName': 'Ebbeling', 'Affiliation': 'New Balance Foundation Obesity Prevention Center, Boston, MA, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Bielak', 'Affiliation': 'New Balance Foundation Obesity Prevention Center, Boston, MA, USA.'}, {'ForeName': 'Paul R', 'Initials': 'PR', 'LastName': 'Lakin', 'Affiliation': ""Institutional Centers for Clinical and Translational Research; Boston Children's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Gloria L', 'Initials': 'GL', 'LastName': 'Klein', 'Affiliation': 'New Balance Foundation Obesity Prevention Center, Boston, MA, USA.'}, {'ForeName': 'Julia M W', 'Initials': 'JMW', 'LastName': 'Wong', 'Affiliation': 'New Balance Foundation Obesity Prevention Center, Boston, MA, USA.'}, {'ForeName': 'Patricia K', 'Initials': 'PK', 'LastName': 'Luoto', 'Affiliation': 'Department of Food and Nutrition, Framingham State University, Framingham, MA, USA.'}, {'ForeName': 'William W', 'Initials': 'WW', 'LastName': 'Wong', 'Affiliation': ""USDA/Agricultural Research Service Children's Nutrition Research Center, Department of Pediatrics, Baylor College of Medicine,Houston, TX, USA.""}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Ludwig', 'Affiliation': 'New Balance Foundation Obesity Prevention Center, Boston, MA, USA.'}]",The Journal of nutrition,['10.1093/jn/nxaa150']
1174,32478917,Randomised clinical trial: palliative long-term abdominal drains vs large-volume paracentesis in refractory ascites due to cirrhosis.,"BACKGROUND


Palliative care remains suboptimal in end-stage liver disease.
AIM


To inform a definitive study, we assessed palliative long-term abdominal drains in end-stage liver disease to determine recruitment, attrition, safety/potential effectiveness, questionnaires/interview uptake/completion and make a preliminary cost comparison.
METHODS


A 12-week feasibility nonblinded randomised controlled trial comparing large-volume paracentesis vs long-term abdominal drains in refractory ascites due to end-stage liver disease with fortnightly home visits for clinical/questionnaire-based assessments. Study success criteria were attrition not >50%, <10% long-term abdominal drain removal due to complications, the long-term abdominal drain group to spend <50% ascites-related study time in hospital vs large-volume paracentesis group and 80% questionnaire/interview uptake/completion.
RESULTS


Of 59 eligible patients, 36 (61%) were randomised, 17 to long-term abdominal drain and 19 to large-volume paracentesis. Following randomisation, median number (IQR) of hospital ascitic drains (long-term abdominal drain group vs large-volume paracentesis group) were 0 (0-1) vs 4 (3-7); week 12 serum albumin (g/L) and serum creatinine (μmol/L) were 29 (26.5-32.5) vs 30 (25-35) and 104.5 (81-115.5) vs 127 (63-158) respectively. Total attrition was 42% (long-term abdominal drain group 47%, large-volume paracentesis group 37%). Median (IQR) fortnightly community/hospital/social care ascites-related costs and percentage study time in hospital were lower in the long-term abdominal drain group, £329 (253-580) vs £843 (603-1060) and 0% (0-0.74) vs 2.75% (2.35-3.84) respectively. Self-limiting cellulitis/leakage occurred in 41% (7/17) in the long-term abdominal drain group vs 11% (2/19) in the large-volume paracentesis group; peritonitis incidence was 6% (1/17) vs 11% (2/19) respectively. Questionnaires/interview uptake/completion were ≥80%; interviews indicated that long-term abdominal drains could transform the care pathway.
CONCLUSIONS


The REDUCe study demonstrates feasibility with preliminary evidence of long-term abdominal drain acceptability/effectiveness/safety and reduction in health resource utilisation.
TRIAL REGISTRATION


ISRCTN30697116, date assigned: 07/10/2015.",2020,Self-limiting cellulitis/leakage occurred in 41% (7/17) in the long-term abdominal drain group vs 11% (2/19) in the large-volume paracentesis group; peritonitis incidence was 6% (1/17) vs 11% (2/19) respectively.,"['59 eligible patients, 36 (61']","['palliative long-term abdominal drains vs large-volume paracentesis', 'large-volume paracentesis vs long-term abdominal drains']","['Total attrition', 'peritonitis incidence', 'serum creatinine', 'Median (IQR) fortnightly community/hospital/social care ascites-related costs and percentage study time in hospital', 'Self-limiting cellulitis/leakage', 'median number (IQR) of hospital ascitic drains']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0587605', 'cui_str': 'Palliative care service'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0441140', 'cui_str': 'Abdominal drain'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C0031154', 'cui_str': 'Peritonitis'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0419189', 'cui_str': 'Social care'}, {'cui': 'C0003962', 'cui_str': 'Ascites'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0040227', 'cui_str': 'Time Studies'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0007642', 'cui_str': 'Cellulitis'}, {'cui': 'C0015376', 'cui_str': 'Extravasation'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439685', 'cui_str': 'Ascitic'}, {'cui': 'C0013103', 'cui_str': 'Drainage procedure'}]",59.0,0.162379,Self-limiting cellulitis/leakage occurred in 41% (7/17) in the long-term abdominal drain group vs 11% (2/19) in the large-volume paracentesis group; peritonitis incidence was 6% (1/17) vs 11% (2/19) respectively.,"[{'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Macken', 'Affiliation': 'Brighton, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Bremner', 'Affiliation': 'Brighton, UK.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Gage', 'Affiliation': 'Guildford, UK.'}, {'ForeName': 'Morro', 'Initials': 'M', 'LastName': 'Touray', 'Affiliation': 'Guildford, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Williams', 'Affiliation': 'Guildford, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Crook', 'Affiliation': 'Brighton, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Mason', 'Affiliation': 'Brighton, UK.'}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Lambert', 'Affiliation': 'Brighton, UK.'}, {'ForeName': 'Catherine J', 'Initials': 'CJ', 'LastName': 'Evans', 'Affiliation': 'Brighton, UK.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Cooper', 'Affiliation': 'Brighton, UK.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Timeyin', 'Affiliation': 'Brighton, UK.'}, {'ForeName': 'Shani', 'Initials': 'S', 'LastName': 'Steer', 'Affiliation': 'Brighton, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Austin', 'Affiliation': 'Brighton, UK.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Parnell', 'Affiliation': 'Brighton, UK.'}, {'ForeName': 'Sam J', 'Initials': 'SJ', 'LastName': 'Thomson', 'Affiliation': 'Worthing, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Sheridan', 'Affiliation': 'Plymouth, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Wright', 'Affiliation': 'Southampton, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Isaacs', 'Affiliation': 'Blackpool, UK.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Hashim', 'Affiliation': 'Brighton, UK.'}, {'ForeName': 'Sumita', 'Initials': 'S', 'LastName': 'Verma', 'Affiliation': 'Brighton, UK.'}]",Alimentary pharmacology & therapeutics,['10.1111/apt.15802']
1175,32474918,"An open-label cluster-randomized controlled trial of chloroquine, hydroxychloroquine or only supportive care in patients admitted with moderate to severe COVID-19 (ARCHAIC)-Protocol publication.",,2020,"Based on unpublished anecdotal positive results in China, CQ is now implemented in China and the Netherlands in moderate to severe COVID-19.","['patients admitted with moderate to severe COVID-19 (ARCHAIC) - Protocol publication', 'COVID-19 in China']","['Chloroquine (CQ) and hydroxychloroquine (HCQ', 'chloroquine, hydroxychloroquine']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0034036', 'cui_str': 'Printed material'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0008269', 'cui_str': 'Chloroquine'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}]",[],,0.0514377,"Based on unpublished anecdotal positive results in China, CQ is now implemented in China and the Netherlands in moderate to severe COVID-19.","[{'ForeName': 'Jesper M', 'Initials': 'JM', 'LastName': 'Weehuizen', 'Affiliation': 'Department of Infectious Diseases, University Medical Centre Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Andy I M', 'Initials': 'AIM', 'LastName': 'Hoepelman', 'Affiliation': 'Department of Infectious Diseases, University Medical Centre Utrecht, Utrecht University, Utrecht, The Netherlands.'}]",European journal of clinical investigation,['10.1111/eci.13297']
1176,32470975,Vitamin B-12 Supplementation during Pregnancy and Early Lactation Does Not Affect Neurophysiologic Outcomes in Children Aged 6 Years.,"BACKGROUND


Deficiency of vitamin B-12 is common in pregnant Indian women. Assessment of neurophysiological measures using event-related potentials (ERPs) may yield additional information on the effects of maternal B-12 supplementation on child brain function.
OBJECTIVES


The objective of the study was to evaluate the effects of vitamin B-12 supplementation (50 μg daily orally) during pregnancy on the childhood ERP measures of positive waveform ∼300 ms after stimulus (P300) and mismatch negativity.
METHODS


This study was a follow-up of children born to pregnant women who received oral vitamin B-12 supplements (n = 62) compared with children of pregnant women who received placebo (n = 70) from a randomized controlled trial. The mean ± SD child age was 72 ± 1 mo. We used the Enobio system to assess the ERP measures P300 and mismatch negativity.
RESULTS


There were no significant differences in the primary outcomes, amplitudes, and latencies of the P300 results and the mismatch negativity between children in the supplementation and placebo groups. We combined the intervention and placebo groups for secondary analyses. On multiple variable regression analysis after adjusting for treatment group, intrauterine growth restriction, and home environment, P300 amplitude in children was significantly higher in the lowest tertile of third-trimester maternal methylmalonic acid (MMA) concentrations (β = 3034.04; 95% CI: 923.24, 5144.83) compared with the highest MMA tertile (β = 1612.12; 95% CI: -258.86, 3483.10, P = 0.005).
CONCLUSIONS


While no significant effects of maternal vitamin B-12 supplementation on children's ERP measures were seen at 72 mo, elevated maternal MMA concentrations in the third trimester were negatively associated with P300 amplitude in children. It may be worthwhile to study the impact of maternal and infant vitamin B-12 supplementation on childhood brain structure and function in longer and larger trials. The parent trial was registered at clinicaltrials.gov as NCT00641862.",2020,"There were no significant differences in the primary outcomes, amplitudes, and latencies of the P300 results and the mismatch negativity between children in the supplementation and placebo groups.","['children born to pregnant women who received', 'n\xa0=\xa062) compared with children of pregnant women who received', 'during Pregnancy and Early Lactation', 'Children', 'Aged 6 Years', 'pregnant Indian women']","['event-related potentials (ERPs', 'vitamin B-12 supplementation', 'oral vitamin B-12 supplements', 'maternal vitamin B-12 supplementation', 'Vitamin B-12 Supplementation', 'placebo']","['childhood ERP measures of positive waveform ∼300\xa0ms after stimulus (P300) and mismatch negativity', 'amplitudes, and latencies of the P300 results and the mismatch negativity', ""children's ERP measures"", 'ERP measures P300 and mismatch negativity', 'maternal MMA concentrations', 'Neurophysiologic Outcomes']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0282171', 'cui_str': 'Event-related potentials'}, {'cui': 'C0042845', 'cui_str': 'Vitamin B 12'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0015214', 'cui_str': 'Evoked potential'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0450448', 'cui_str': 'Waveforms'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0025787', 'cui_str': 'Methyl malonic acid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.385632,"There were no significant differences in the primary outcomes, amplitudes, and latencies of the P300 results and the mismatch negativity between children in the supplementation and placebo groups.","[{'ForeName': 'Krishnamachari', 'Initials': 'K', 'LastName': 'Srinivasan', 'Affiliation': ""Division of Mental Health and Neurosciences, St. John's Research Institute, Bengaluru, Karnataka, India.""}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Thomas', 'Affiliation': ""Division of Mental Health and Neurosciences, St. John's Research Institute, Bengaluru, Karnataka, India.""}, {'ForeName': 'Shilpa', 'Initials': 'S', 'LastName': 'Anand', 'Affiliation': ""Division of Mental Health and Neurosciences, St. John's Research Institute, Bengaluru, Karnataka, India.""}, {'ForeName': 'Mahesh', 'Initials': 'M', 'LastName': 'Jayachandra', 'Affiliation': ""Division of Mental Health and Neurosciences, St. John's Research Institute, Bengaluru, Karnataka, India.""}, {'ForeName': 'Tinku', 'Initials': 'T', 'LastName': 'Thomas', 'Affiliation': ""Department of Biostatistics, St. John's Medical College, Bengaluru, Karnataka, India.""}, {'ForeName': 'Tor Arne', 'Initials': 'TA', 'LastName': 'Strand', 'Affiliation': 'Innlandet Hosptial Trust, Lillehammer, Norway.'}, {'ForeName': 'Anura V', 'Initials': 'AV', 'LastName': 'Kurpad', 'Affiliation': ""Division of Nutrition, St. John's Research Institute, Bengaluru, Karnataka, India.""}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Duggan', 'Affiliation': 'Department of Nutrition, Harvard TH Chan School of Public Health, Boston, MA, USA.'}]",The Journal of nutrition,['10.1093/jn/nxaa123']
1177,32474156,Efficacy of dupilumab on clinical outcomes in patients with asthma and perennial allergic rhinitis.,"BACKGROUND


Comorbid perennial allergic rhinitis (PAR) or year-round aeroallergen sensitivity substantially contributes to disease burden in patients with asthma. Dupilumab blocks the shared receptor for interleukin (IL) 4 and IL-13, key drivers of type 2 inflammation that play important roles in asthma and PAR. In the LIBERTY ASTHMA QUEST trial (NCT02414854), dupilumab reduced severe asthma exacerbations and improved forced expiratory volume in 1 second (FEV 1 ) in patients with uncontrolled, moderate-to-severe asthma, with greater efficacy observed in patients with elevated type 2 inflammatory biomarkers at baseline (blood eosinophils and fractional exhaled nitric oxide).
OBJECTIVE


To assess dupilumab efficacy in LIBERTY ASTHMA QUEST patients with comorbid PAR.
METHODS


Severe asthma exacerbation rates, FEV 1 , asthma control (5-item Asthma Control Questionnaire), rhinoconjunctivitis-specific health-related quality of life (Standardized Rhinoconjunctivitis Quality of Life Questionnaire +12 scores), and type 2 inflammatory biomarkers during the 52-week treatment period were assessed.
RESULTS


A total of 814 of the 1902 patients (42.8%) had comorbid PAR (defined as an allergic rhinitis history and ≥1 perennial aeroallergen specific immunoglobulin E (IgE) level ≥0.35 kU/L at baseline). Dupilumab, 200 and 300 mg every 2 weeks, vs placebo reduced severe exacerbations rates by 32.2% and 34.6% (P < .05 for both) and improved FEV 1  at week 12 by 0.14 L and 0.18 L (P < .01 for both); greater efficacy was observed in patients with elevated baseline blood eosinophil counts (≥300 cells/μL) and fractional exhaled nitric oxide. Dupilumab treatment also numerically improved the 5-item Asthma Control Questionnaire and Standardized Rhinoconjunctivitis Quality of Life Questionnaire +12 scores and suppressed type 2 inflammatory biomarkers.
CONCLUSION


Dupilumab improved key asthma-related outcomes, asthma control, and rhinoconjunctivitis-specific health-related quality of life while suppressing type 2 inflammatory biomarkers and perennial allergen-specific IgE in patients with moderate-to-severe asthma and comorbid PAR, highlighting its dual inhibitory effects on IL-4 and IL-13 and its role in managing asthma and PAR.",2020,"Dupilumab 200 and 300 mg q2w versus placebo reduced severe exacerbations rates by 32.2% and 34.6% (both P<.05), and improved FEV1 at Week 12 by 0.14 L and 0.18 L (both P<.01); greater efficacy was observed in patients with elevated baseline blood eosinophils (≥300 cells/μL) and FeNO.","['asthma patients', 'patients with asthma and perennial allergic rhinitis', 'patients with moderate-to-severe asthma and comorbid PAR', 'patients had comorbid PAR', 'QUEST patients with comorbid PAR (allergic rhinitis history and ≥1 perennial aeroallergen-specific IgE ≥0.35 kU/L at baseline']","['Dupilumab', 'placebo']","['Severe asthma exacerbation rates, FEV1, asthma control (ACQ-5), rhinoconjunctivitis-specific health-related quality of life (HRQoL) (RQLQ[S]+12), and type 2 inflammatory biomarkers', 'forced expiratory volume', 'ACQ-5 and RQLQ(s)+12 scores, and suppressed type 2 inflammatory biomarkers', 'severe exacerbations rates', 'FEV1', 'dupilumab efficacy', 'efficacy']","[{'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035457', 'cui_str': 'Perennial allergic rhinitis'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0001697', 'cui_str': 'Aeroallergen'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0020846', 'cui_str': 'Immunoglobulin E'}, {'cui': 'C0439340', 'cui_str': 'kU/L'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]","[{'cui': 'C3660996', 'cui_str': 'dupilumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0581126', 'cui_str': 'Severe asthma'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2919686', 'cui_str': 'Asthma control questionnaire'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1260953', 'cui_str': 'Suppressed'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C3660996', 'cui_str': 'dupilumab'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.0837837,"Dupilumab 200 and 300 mg q2w versus placebo reduced severe exacerbations rates by 32.2% and 34.6% (both P<.05), and improved FEV1 at Week 12 by 0.14 L and 0.18 L (both P<.01); greater efficacy was observed in patients with elevated baseline blood eosinophils (≥300 cells/μL) and FeNO.","[{'ForeName': 'William W', 'Initials': 'WW', 'LastName': 'Busse', 'Affiliation': 'Division of Allergy, Pulmonary and Critical Care Medicine, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin. Electronic address: wwb@medicine.wisc.edu.'}, {'ForeName': 'Jorge F', 'Initials': 'JF', 'LastName': 'Maspero', 'Affiliation': 'Fundación CIDEA, Buenos Aires, Argentina.'}, {'ForeName': 'Yufang', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, New York.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Corren', 'Affiliation': 'David Geffen School of Medicine at University of California, Los Angeles, Los Angeles, California.'}, {'ForeName': 'Nicola A', 'Initials': 'NA', 'LastName': 'Hanania', 'Affiliation': 'Baylor College of Medicine, Texas Medical Center, Houston, Texas.'}, {'ForeName': 'Bradley E', 'Initials': 'BE', 'LastName': 'Chipps', 'Affiliation': 'Capital Allergy and Respiratory Disease Center, Sacramento, California.'}, {'ForeName': 'Constance H', 'Initials': 'CH', 'LastName': 'Katelaris', 'Affiliation': 'Campbelltown Hospital and Western Sydney University, Campbelltown, Australia.'}, {'ForeName': 'J Mark', 'Initials': 'JM', 'LastName': 'FitzGerald', 'Affiliation': 'The University of British Columbia, Vancouver, British Columbia.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Quirce', 'Affiliation': 'Department of Allergy, Hospital La Paz Institute for Health Research (IdiPAZ), Madrid, Spain.'}, {'ForeName': 'Linda B', 'Initials': 'LB', 'LastName': 'Ford', 'Affiliation': 'Asthma and Allergy Center, Bellevue, Nebraska.'}, {'ForeName': 'Megan S', 'Initials': 'MS', 'LastName': 'Rice', 'Affiliation': 'Sanofi, Cambridge, Massachusetts.'}, {'ForeName': 'Siddhesh', 'Initials': 'S', 'LastName': 'Kamat', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, New York.'}, {'ForeName': 'Asif H', 'Initials': 'AH', 'LastName': 'Khan', 'Affiliation': 'Sanofi, Chilly-Mazarin, France.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Jagerschmidt', 'Affiliation': 'Sanofi, Chilly-Mazarin, France.'}, {'ForeName': 'Sivan', 'Initials': 'S', 'LastName': 'Harel', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, New York.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Rowe', 'Affiliation': 'Sanofi, Bridgewater, New Jersey.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Pirozzi', 'Affiliation': 'Sanofi, Bridgewater, New Jersey.'}, {'ForeName': 'Nikhil', 'Initials': 'N', 'LastName': 'Amin', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, New York.'}, {'ForeName': 'Marcella', 'Initials': 'M', 'LastName': 'Ruddy', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, New York.'}, {'ForeName': 'Neil M H', 'Initials': 'NMH', 'LastName': 'Graham', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, New York.'}, {'ForeName': 'Ariel', 'Initials': 'A', 'LastName': 'Teper', 'Affiliation': 'Sanofi, Bridgewater, New Jersey.'}]","Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology",['10.1016/j.anai.2020.05.026']
1178,32579810,Serum Urate Lowering with Allopurinol and Kidney Function in Type 1 Diabetes.,"BACKGROUND


Higher serum urate levels are associated with an increased risk of diabetic kidney disease. Lowering of the serum urate level with allopurinol may slow the decrease in the glomerular filtration rate (GFR) in persons with type 1 diabetes and early-to-moderate diabetic kidney disease.
METHODS


In a double-blind trial, we randomly assigned participants with type 1 diabetes, a serum urate level of at least 4.5 mg per deciliter, an estimated GFR of 40.0 to 99.9 ml per minute per 1.73 m 2  of body-surface area, and evidence of diabetic kidney disease to receive allopurinol or placebo. The primary outcome was the baseline-adjusted GFR, as measured with iohexol, after 3 years plus a 2-month washout period. Secondary outcomes included the decrease in the iohexol-based GFR per year and the urinary albumin excretion rate after washout. Safety was also assessed.
RESULTS


A total of 267 patients were assigned to receive allopurinol and 263 to receive placebo. The mean age was 51.1 years, the mean duration of diabetes 34.6 years, and the mean glycated hemoglobin level 8.2%. The mean baseline iohexol-based GFR was 68.7 ml per minute per 1.73 m 2  in the allopurinol group and 67.3 ml per minute per 1.73 m 2  in the placebo group. During the intervention period, the mean serum urate level decreased from 6.1 to 3.9 mg per deciliter with allopurinol and remained at 6.1 mg per deciliter with placebo. After washout, the between-group difference in the mean iohexol-based GFR was 0.001 ml per minute per 1.73 m 2  (95% confidence interval [CI], -1.9 to 1.9; P = 0.99). The mean decrease in the iohexol-based GFR was -3.0 ml per minute per 1.73 m 2  per year with allopurinol and -2.5 ml per minute per 1.73 m 2  per year with placebo (between-group difference, -0.6 ml per minute per 1.73 m 2  per year; 95% CI, -1.5 to 0.4). The mean urinary albumin excretion rate after washout was 40% (95% CI, 0 to 80) higher with allopurinol than with placebo. The frequency of serious adverse events was similar in the two groups.
CONCLUSIONS


We found no evidence of clinically meaningful benefits of serum urate reduction with allopurinol on kidney outcomes among patients with type 1 diabetes and early-to-moderate diabetic kidney disease. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases and others; PERL ClinicalTrials.gov number, NCT02017171.).",2020,"The mean urinary albumin excretion rate after washout was 40% (95% CI, 0 to 80) higher with allopurinol than with placebo.","['persons with type 1 diabetes and early-to-moderate diabetic kidney disease', 'Type 1 Diabetes', 'patients with type 1 diabetes and early-to-moderate diabetic kidney disease', '267 patients']","['placebo', 'allopurinol or placebo', 'allopurinol', 'Allopurinol']","['Safety', 'frequency of serious adverse events', 'baseline-adjusted GFR', 'iohexol-based GFR per year and the urinary albumin excretion rate', 'mean baseline iohexol-based GFR', 'mean serum urate level', 'iohexol-based GFR', 'kidney outcomes', 'mean urinary albumin excretion rate', 'mean iohexol-based GFR', 'glomerular filtration rate (GFR']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0011881', 'cui_str': 'Kidney disorder due to diabetes mellitus'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517672', 'cui_str': '267'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0002144', 'cui_str': 'Allopurinol'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0022005', 'cui_str': 'Iohexol'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439508', 'cui_str': '/year'}, {'cui': 'C0585937', 'cui_str': 'Albumin excretion rate measurement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0455272', 'cui_str': 'Serum urate measurement'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",267.0,0.615998,"The mean urinary albumin excretion rate after washout was 40% (95% CI, 0 to 80) higher with allopurinol than with placebo.","[{'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Doria', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Andrzej T', 'Initials': 'AT', 'LastName': 'Galecki', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Cathie', 'Initials': 'C', 'LastName': 'Spino', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Rodica', 'Initials': 'R', 'LastName': 'Pop-Busui', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'David Z', 'Initials': 'DZ', 'LastName': 'Cherney', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Ildiko', 'Initials': 'I', 'LastName': 'Lingvay', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Afshin', 'Initials': 'A', 'LastName': 'Parsa', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Rossing', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Ronald J', 'Initials': 'RJ', 'LastName': 'Sigal', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Afkarian', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Ronnie', 'Initials': 'R', 'LastName': 'Aronson', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'M Luiza', 'Initials': 'ML', 'LastName': 'Caramori', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Jill P', 'Initials': 'JP', 'LastName': 'Crandall', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Ian H', 'Initials': 'IH', 'LastName': 'de Boer', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Thomas G', 'Initials': 'TG', 'LastName': 'Elliott', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Allison B', 'Initials': 'AB', 'LastName': 'Goldfine', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'J Sonya', 'Initials': 'JS', 'LastName': 'Haw', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Irl B', 'Initials': 'IB', 'LastName': 'Hirsch', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Amy B', 'Initials': 'AB', 'LastName': 'Karger', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Maahs', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Janet B', 'Initials': 'JB', 'LastName': 'McGill', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Molitch', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Bruce A', 'Initials': 'BA', 'LastName': 'Perkins', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Sarit', 'Initials': 'S', 'LastName': 'Polsky', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Marlon', 'Initials': 'M', 'LastName': 'Pragnell', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'William N', 'Initials': 'WN', 'LastName': 'Robiner', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Sylvia E', 'Initials': 'SE', 'LastName': 'Rosas', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Senior', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Katherine R', 'Initials': 'KR', 'LastName': 'Tuttle', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Guillermo E', 'Initials': 'GE', 'LastName': 'Umpierrez', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Amisha', 'Initials': 'A', 'LastName': 'Wallia', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Ruth S', 'Initials': 'RS', 'LastName': 'Weinstock', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Chunyi', 'Initials': 'C', 'LastName': 'Wu', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Mauer', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1916624']
1179,32482616,Ticagrelor alone or conventional dual antiplatelet therapy in patients with stable or acute coronary syndromes.,"AIMS


The aim of this study was to investigate the effect of ticagrelor monotherapy after one-month dual antiplatelet therapy (DAPT) or conventional DAPT in patients with or without acute coronary syndrome (ACS) in the GLOBAL LEADERS Adjudication Sub-StudY (GLASSY).
METHODS AND RESULTS


Risk estimates were expressed as rate ratios (RR) with 95% confidence intervals (CI). A total of 3,840 ACS and 3,745 stable ischaemic heart disease (SIHD) patients were included. At two years, rates of the co-primary efficacy endpoint, a composite of death, myocardial infarction, stroke or urgent target vessel revascularisation, were 7.94% in the experimental and 9.68% in the control group (RR 0.82, 95% CI: 0.66-1.01) among ACS patients and 6.31% in the experimental and 7.14% in the control group (RR 0.89, 95% CI: 0.69-1.13) among SIHD patients (pint=0.63). Trends for lower and higher risk of BARC 3 or 5 bleeding with the experimental strategy in ACS (2.27% vs 3.00%, RR 0.76, 95% CI: 0.51-1.12) and SIHD (2.70% vs 1.96%, RR 1.39, 95% CI: 0.91-2.12) patients, respectively, were observed with significant interaction testing (pint=0.039). A net clinical benefit endpoint, the composite of both co-primary study endpoints, favoured the experimental treatment among ACS patients only.
CONCLUSIONS


Ticagrelor monotherapy after one-month DAPT provided consistent treatment effects on ischaemic endpoints in patients with or without ACS but only the former experienced a net clinical benefit. ClinicalTrials.gov identifier: NCT03231059.",2020,"A net clinical benefit endpoint, composite of both co-primary study endpoints, favored the experimental treatment among ACS patients only.
","['patients with stable or acute coronary syndromes', 'patients with or without acute coronary syndrome (ACS', '3,745 SIHD (stable ischemic heart disease', 'patients with or without ACS']","['Ticagrelor alone or conventional dual antiplatelet therapy', 'ticagrelor monotherapy', 'antiplatelet therapy (DAPT) or conventional DAPT']","['rate ratios (RR', 'rates of co-primary efficacy endpoint, composite of death, myocardial infarction, stroke or urgent target-vessel revascularization', 'ischemic endpoints', 'SIHD']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0151744', 'cui_str': 'Myocardial ischemia'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0449618', 'cui_str': 'Target vessel'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}]",,0.0916424,"A net clinical benefit endpoint, composite of both co-primary study endpoints, favored the experimental treatment among ACS patients only.
","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Franzone', 'Affiliation': 'Department of Advanced Biomedical Sciences, Federico II University of Naples, Naples, Italy.'}, {'ForeName': 'Eugène P', 'Initials': 'EP', 'LastName': 'McFadden', 'Affiliation': ''}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Leonardi', 'Affiliation': ''}, {'ForeName': 'Raffaele', 'Initials': 'R', 'LastName': 'Piccolo', 'Affiliation': ''}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Vranckx', 'Affiliation': ''}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': ''}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hamm', 'Affiliation': ''}, {'ForeName': 'Philippe Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': ''}, {'ForeName': 'Dik', 'Initials': 'D', 'LastName': 'Heg', 'Affiliation': ''}, {'ForeName': 'Mattia', 'Initials': 'M', 'LastName': 'Branca', 'Affiliation': ''}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Jüni', 'Affiliation': ''}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': ''}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Valgimigli', 'Affiliation': ''}]",EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology,['10.4244/EIJ-D-20-00145']
1180,32479807,Short-Term Changes in Prediction Error after Cataract Surgery in Eyes Receiving 1 of 3 Types of Single-Piece Acrylic Intraocular Lenses.,"PURPOSE


To compare short-term changes in refractive prediction error (PE) after phacoemulsification among eyes receiving different types of single-piece acrylic intraocular lenses (IOLs).
DESIGN


Randomized clinical trial.
METHODS


A total of 195 eyes of 195 patients scheduled for implantation of a single-piece acrylic IOL were randomly assigned to receive 1 of 3 IOLs: 1) an Alcon model SN60WF, 2) a Hoya model XY-1, or 3) an AMO model ZCB00V. Manifest spherical equivalent (MRSE) value, PE, and changes in PE were examined at 1 day and at 1 and 2 months postoperatively and were compared among groups.
RESULTS


The mean MRSE and PE significantly changed toward myopia between 1 day and 2 months postoperatively in all groups (P < .0001). The MRSE and PE did not differ significantly among groups at 1 day and 1 month postoperatively and were significantly smaller in the SN60WF group than in the XY-1 and ZCB00V groups at 2 months (P ≤ .0006). The PE change between 1 day and 2 months postoperatively was significantly smaller in the SN60WF group than in the other groups (P = .0062). IOL type and changes in anterior chamber depth and corneal curvature independently correlated with PE changes.
CONCLUSIONS


The MRSE and PE showed a significant myopic change for 2 months postoperatively in eyes implanted with 1 of 3 types of single-piece acrylic IOLs and were significantly smaller in the SN60WF than in the XY-1 and ZCB00V groups. Changes in PE during the 2 postoperative months were smaller in the SN60WF IOLs than in the other IOLs, suggesting that postoperative refractive stability differs among single-piece acrylic IOLs.",2020,"The MRSE and PE did not differ significantly among groups at 1 day and 1 month postoperatively, and were significantly smaller in the SN60WF group than in the XY-1 and ZCB00V groups at 2 months (P≤.0006).","['One-hundred ninety-five eyes of 195 patients scheduled for implantation of a single-piece acrylic IOL', 'eyes receiving different types of single-piece acrylic intraocular lenses (IOLs']",['SN60WF'],"['PE change', 'IOL type, and changes in anterior chamber depth and corneal curvature', 'mean MRSE and PE', 'MRSE and PE', 'AMO ZCB00V. Manifest spherical equivalent value (MRSE), PE, and changes in PE', 'refractive prediction error (PE']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4517906', 'cui_str': '95'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0440181', 'cui_str': 'Acrylic dental material'}, {'cui': 'C0281658', 'cui_str': 'Intraocular Lymphoma'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}]",[],"[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0281658', 'cui_str': 'Intraocular Lymphoma'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0429492', 'cui_str': 'Depth of anterior chamber'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205319', 'cui_str': 'Manifest'}, {'cui': 'C0332501', 'cui_str': 'Spherical shape'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",195.0,0.0496226,"The MRSE and PE did not differ significantly among groups at 1 day and 1 month postoperatively, and were significantly smaller in the SN60WF group than in the XY-1 and ZCB00V groups at 2 months (P≤.0006).","[{'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Hayashi', 'Affiliation': 'Hayashi Eye Hospital, Fukuoka, Japan. Electronic address: hayashi-ken@hayashi.or.jp.'}, {'ForeName': 'Motoaki', 'Initials': 'M', 'LastName': 'Yoshida', 'Affiliation': 'Hayashi Eye Hospital, Fukuoka, Japan.'}, {'ForeName': 'Shunsuke', 'Initials': 'S', 'LastName': 'Hayashi', 'Affiliation': 'Department of Ophthalmology, National Hospital Organization Saitama Hospital, Saitama, Japan; Department of Ophthalmology, Keio University Faculty of Medicine, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Yoshimura', 'Affiliation': 'Hayashi Eye Hospital, Fukuoka, Japan.'}]",American journal of ophthalmology,['10.1016/j.ajo.2020.05.031']
1181,32445440,Remdesivir for the Treatment of Covid-19 - Final Report.,"BACKGROUND


Although several therapeutic agents have been evaluated for the treatment of coronavirus disease 2019 (Covid-19), no antiviral agents have yet been shown to be efficacious.
METHODS


We conducted a double-blind, randomized, placebo-controlled trial of intravenous remdesivir in adults who were hospitalized with Covid-19 and had evidence of lower respiratory tract infection. Patients were randomly assigned to receive either remdesivir (200 mg loading dose on day 1, followed by 100 mg daily for up to 9 additional days) or placebo for up to 10 days. The primary outcome was the time to recovery, defined by either discharge from the hospital or hospitalization for infection-control purposes only.
RESULTS


A total of 1062 patients underwent randomization (with 541 assigned to remdesivir and 521 to placebo). Those who received remdesivir had a median recovery time of 10 days (95% confidence interval [CI], 9 to 11), as compared with 15 days (95% CI, 13 to 18) among those who received placebo (rate ratio for recovery, 1.29; 95% CI, 1.12 to 1.49; P<0.001, by a log-rank test). In an analysis that used a proportional-odds model with an eight-category ordinal scale, the patients who received remdesivir were found to be more likely than those who received placebo to have clinical improvement at day 15 (odds ratio, 1.5; 95% CI, 1.2 to 1.9, after adjustment for actual disease severity). The Kaplan-Meier estimates of mortality were 6.7% with remdesivir and 11.9% with placebo by day 15 and 11.4% with remdesivir and 15.2% with placebo by day 29 (hazard ratio, 0.73; 95% CI, 0.52 to 1.03). Serious adverse events were reported in 131 of the 532 patients who received remdesivir (24.6%) and in 163 of the 516 patients who received placebo (31.6%).
CONCLUSIONS


Our data show that remdesivir was superior to placebo in shortening the time to recovery in adults who were hospitalized with Covid-19 and had evidence of lower respiratory tract infection. (Funded by the National Institute of Allergy and Infectious Diseases and others; ACTT-1 ClinicalTrials.gov number, NCT04280705.).",2020,"CONCLUSIONS


Remdesivir was superior to placebo in shortening the time to recovery in adults hospitalized with Covid-19 and evidence of lower respiratory tract infection.","['1059 patients (538 assigned to remdesivir and 521 to', 'adults hospitalized with Covid-19 and evidence of lower respiratory tract infection', '1063 patients underwent randomization', 'adults hospitalized with Covid-19 with evidence of lower respiratory tract involvement']","['remdesivir', 'intravenous remdesivir', 'placebo']","['median recovery time', 'time to recovery, defined by either discharge from the hospital or hospitalization for infection-control purposes only', 'Serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C4726677', 'cui_str': 'remdesivir'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0149725', 'cui_str': 'Lower respiratory tract infection'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0458579', 'cui_str': 'Lower respiratory tract structure'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}]","[{'cui': 'C4726677', 'cui_str': 'remdesivir'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0085557', 'cui_str': 'Infection control procedure'}, {'cui': 'C1285529', 'cui_str': 'Purpose'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",1063.0,0.687871,"CONCLUSIONS


Remdesivir was superior to placebo in shortening the time to recovery in adults hospitalized with Covid-19 and evidence of lower respiratory tract infection.","[{'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Beigel', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Kay M', 'Initials': 'KM', 'LastName': 'Tomashek', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Lori E', 'Initials': 'LE', 'LastName': 'Dodd', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Aneesh K', 'Initials': 'AK', 'LastName': 'Mehta', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Barry S', 'Initials': 'BS', 'LastName': 'Zingman', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Andre C', 'Initials': 'AC', 'LastName': 'Kalil', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Hohmann', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Helen Y', 'Initials': 'HY', 'LastName': 'Chu', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Luetkemeyer', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Kline', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Lopez de Castilla', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Finberg', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Kerry', 'Initials': 'K', 'LastName': 'Dierberg', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Tapson', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Lanny', 'Initials': 'L', 'LastName': 'Hsieh', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Thomas F', 'Initials': 'TF', 'LastName': 'Patterson', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Paredes', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Sweeney', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Short', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Giota', 'Initials': 'G', 'LastName': 'Touloumi', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'David Chien', 'Initials': 'DC', 'LastName': 'Lye', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Norio', 'Initials': 'N', 'LastName': 'Ohmagari', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Myoung-Don', 'Initials': 'MD', 'LastName': 'Oh', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Guillermo M', 'Initials': 'GM', 'LastName': 'Ruiz-Palacios', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Benfield', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Gerd', 'Initials': 'G', 'LastName': 'Fätkenheuer', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Mark G', 'Initials': 'MG', 'LastName': 'Kortepeter', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Atmar', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'C Buddy', 'Initials': 'CB', 'LastName': 'Creech', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Lundgren', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Abdel G', 'Initials': 'AG', 'LastName': 'Babiker', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Pett', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Neaton', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Timothy H', 'Initials': 'TH', 'LastName': 'Burgess', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Tyler', 'Initials': 'T', 'LastName': 'Bonnett', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Green', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Mat', 'Initials': 'M', 'LastName': 'Makowski', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Anu', 'Initials': 'A', 'LastName': 'Osinusi', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Seema', 'Initials': 'S', 'LastName': 'Nayak', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'H Clifford', 'Initials': 'HC', 'LastName': 'Lane', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2007764']
1182,32586366,Efficacy and safety of umbilical cord mesenchymal stem cells in treatment of cesarean section skin scars: a randomized clinical trial.,"BACKGROUND


Pathological skin scars, caused by cesarean section, affected younger mothers esthetically and psychosocially and to some extent frustrated obstetricians and dermatologists. Umbilical cord mesenchymal stem cells (UC-MSCs), as a population of multipotent cells, are abundant in human tissues, providing several possibilities for their effects on skin scar tissues. Herein, we performed a randomized, double-blind, placebo-controlled, three-arm clinical trial, aiming to assess the efficacy and safety of UC-MSCs in the treatment of cesarean section skin scars among primiparous singleton pregnant women.
METHODS


Ninety primiparous singleton pregnant women undergoing elective cesarean section were randomly allocated to receive placebo, low-dose (3 × 10 6  cells), or high-dose (6 × 10 6  cells) transdermal hydrogel UC-MSCs on the surface of the skin incision. The primary outcome was cesarean section skin scars followed after the sixth month, assessed by the Vancouver Scar Scale (VSS).
RESULTS


All the participants completed their trial of the primary outcome according to the protocol. The mean score of estimated total VSS was 5.52 in all participants at the sixth-month follow-up, with 6.43 in the placebo group, 5.18 in the low-dose group, and 4.71 in the high-dose group, respectively. No significant difference was found between-group in the mean scores for VSS at the sixth month. Additional prespecified secondary outcomes were not found with significant differences among groups either. No obvious side effects or adverse effects were reported in any of the three arms.
CONCLUSION


This randomized clinical trial showed that UC-MSCs did not demonstrate the effects of improvement of cesarean section skin scars.
TRIAL REGISTRATION


ClinicalTrials.gov identifier, NCT02772289. Registered on 13 May 2016.",2020,"No obvious side effects or adverse effects were reported in any of the three arms.
","['primiparous singleton pregnant women', 'Ninety primiparous singleton pregnant women undergoing elective cesarean section', 'cesarean section skin scars']","['UC-MSCs', 'placebo, low-dose (3\u2009×\u200910 6  cells), or high-dose (6\u2009×\u200910 6  cells) transdermal hydrogel UC-MSCs', 'umbilical cord mesenchymal stem cells', 'Umbilical cord mesenchymal stem cells (UC-MSCs', 'placebo']","['cesarean section skin scars', 'Efficacy and safety', 'efficacy and safety', 'Vancouver Scar Scale (VSS', 'mean score of estimated total VSS', 'adverse effects']","[{'cui': 'C0033150', 'cui_str': 'Para 1'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}]","[{'cui': 'C0041633', 'cui_str': 'Umbilical cord structure'}, {'cui': 'C1257975', 'cui_str': 'Mesenchymal stem cell'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0040652', 'cui_str': 'Transdermal route'}, {'cui': 'C0063083', 'cui_str': 'Hydrogel'}]","[{'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",90.0,0.521774,"No obvious side effects or adverse effects were reported in any of the three arms.
","[{'ForeName': 'Dazhi', 'Initials': 'D', 'LastName': 'Fan', 'Affiliation': 'Foshan Institute of Fetal Medicine, Affiliated Foshan Maternity & Child Healthcare Hospital, Southern Medical University, 11 Renminxi Road, Foshan, 528000, Guangdong, China.'}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Zeng', 'Affiliation': 'Department of Obstetrics, Affiliated Foshan Maternity & Child Healthcare Hospital, Southern Medical University, 11 Renminxi Road, Foshan, 528000, Guangdong, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Xia', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Anhui Medical University, Hefei, 230032, Anhui, China.'}, {'ForeName': 'Shuzhen', 'Initials': 'S', 'LastName': 'Wu', 'Affiliation': 'Department of Obstetrics, Affiliated Foshan Maternity & Child Healthcare Hospital, Southern Medical University, 11 Renminxi Road, Foshan, 528000, Guangdong, China.'}, {'ForeName': 'Shaoxin', 'Initials': 'S', 'LastName': 'Ye', 'Affiliation': 'Foshan Institute of Fetal Medicine, Affiliated Foshan Maternity & Child Healthcare Hospital, Southern Medical University, 11 Renminxi Road, Foshan, 528000, Guangdong, China.'}, {'ForeName': 'Jiaming', 'Initials': 'J', 'LastName': 'Rao', 'Affiliation': 'Foshan Institute of Fetal Medicine, Affiliated Foshan Maternity & Child Healthcare Hospital, Southern Medical University, 11 Renminxi Road, Foshan, 528000, Guangdong, China.'}, {'ForeName': 'Dongxin', 'Initials': 'D', 'LastName': 'Lin', 'Affiliation': 'Foshan Institute of Fetal Medicine, Affiliated Foshan Maternity & Child Healthcare Hospital, Southern Medical University, 11 Renminxi Road, Foshan, 528000, Guangdong, China.'}, {'ForeName': 'Huishan', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Foshan Institute of Fetal Medicine, Affiliated Foshan Maternity & Child Healthcare Hospital, Southern Medical University, 11 Renminxi Road, Foshan, 528000, Guangdong, China.'}, {'ForeName': 'Huiting', 'Initials': 'H', 'LastName': 'Ma', 'Affiliation': 'Foshan Institute of Fetal Medicine, Affiliated Foshan Maternity & Child Healthcare Hospital, Southern Medical University, 11 Renminxi Road, Foshan, 528000, Guangdong, China.'}, {'ForeName': 'Zhongchao', 'Initials': 'Z', 'LastName': 'Han', 'Affiliation': 'State Key Laboratory of Experimental Hematology, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin, 300020, China. hanzhongchao@hotmail.com.'}, {'ForeName': 'Xiaoling', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': 'Foshan Institute of Fetal Medicine, Affiliated Foshan Maternity & Child Healthcare Hospital, Southern Medical University, 11 Renminxi Road, Foshan, 528000, Guangdong, China. fsguoxl@163.com.'}, {'ForeName': 'Zhengping', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Foshan Institute of Fetal Medicine, Affiliated Foshan Maternity & Child Healthcare Hospital, Southern Medical University, 11 Renminxi Road, Foshan, 528000, Guangdong, China. liuzphlk81@outlook.com.'}]",Stem cell research & therapy,['10.1186/s13287-020-01695-7']
1183,32476236,Microbiota changes induced by microencapsulated sodium butyrate in patients with inflammatory bowel disease.,"BACKGROUND


Butyrate has shown anti-inflammatory and regenerative properties, providing symptomatic relief when orally supplemented in patients suffering from various colonic diseases. We investigated the effect of a colonic-delivery formulation of butyrate on the fecal microbiota of patients with inflammatory bowel diseases (IBDs).
METHODS


In this double-blind, placebo-controlled, pilot study, 49 IBD patients (n = 19 Crohn's disease, CD and n = 30 ulcerative colitis, UC) were randomized to oral administration of microencapsulated-sodium-butyrate (BLM) or placebo for 2 months, in addition to conventional therapy. Eighteen healthy volunteers (HVs) were recruited to provide a healthy microbiota model of the local people. Fecal microbiota from stool samples was assessed by 16S sequencing. Clinical disease activity and quality of life (QoL) were evaluated before and after treatment.
KEY RESULTS


At baseline, HVs showed a different microbiota composition compared with IBD patients. Sodium-butyrate altered the gut microbiota of IBD patients by increasing bacteria able to produce SCFA in UC patients (Lachnospiraceae spp.) and the butyrogenic colonic bacteria in CD patients (Butyricicoccus). In UC patients, QoL was positively affected by treatment.
CONCLUSIONS AND INFERENCES


Sodium-butyrate supplementation increases the growth of bacteria able to produce SCFA with potentially anti-inflammatory action. The clinical impact of this finding requires further investigation.",2020,"At baseline, HVs showed a different microbiota composition compared with IBD patients.","[""49 IBD patients (n\xa0=\xa019 Crohn's disease, CD and n\xa0=\xa030 ulcerative colitis, UC"", 'patients with inflammatory bowel diseases (IBDs', 'patients suffering from various colonic diseases', 'patients with inflammatory bowel disease', 'Eighteen healthy volunteers (HVs']","['Sodium-butyrate', 'microencapsulated-sodium-butyrate (BLM) or placebo', 'butyrate', 'microencapsulated sodium butyrate', 'placebo']","['Clinical disease activity and quality of life (QoL', 'QoL']","[{'cui': 'C0021390', 'cui_str': 'Inflammatory bowel disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0009373', 'cui_str': 'Disorder of colon'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0142812', 'cui_str': 'Butyric Acid, Sodium Salt'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006521', 'cui_str': 'Butyrates'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",49.0,0.0508898,"At baseline, HVs showed a different microbiota composition compared with IBD patients.","[{'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Facchin', 'Affiliation': 'Department of Surgery, Oncology and Gastroenterology (DISCOG), University Hospital of Padua, Padua, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Vitulo', 'Affiliation': 'Department of Biotechnology, University of Verona, Verona, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Calgaro', 'Affiliation': 'Department of Biotechnology, University of Verona, Verona, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Buda', 'Affiliation': 'Department of Surgery, Oncology and Gastroenterology (DISCOG), University Hospital of Padua, Padua, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Romualdi', 'Affiliation': 'Department of Biology, University of Padua, Padua, Italy.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Pohl', 'Affiliation': 'Department of Gastroenterology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Perini', 'Affiliation': 'Department of Surgery, Oncology and Gastroenterology (DISCOG), University Hospital of Padua, Padua, Italy.'}, {'ForeName': 'Greta', 'Initials': 'G', 'LastName': 'Lorenzon', 'Affiliation': 'Department of Surgery, Oncology and Gastroenterology (DISCOG), University Hospital of Padua, Padua, Italy.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Marinelli', 'Affiliation': 'Department of Surgery, Oncology and Gastroenterology (DISCOG), University Hospital of Padua, Padua, Italy.'}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': ""D'Incà"", 'Affiliation': 'Department of Surgery, Oncology and Gastroenterology (DISCOG), University Hospital of Padua, Padua, Italy.'}, {'ForeName': 'Giacomo Carlo', 'Initials': 'GC', 'LastName': 'Sturniolo', 'Affiliation': 'Department of Surgery, Oncology and Gastroenterology (DISCOG), University Hospital of Padua, Padua, Italy.'}, {'ForeName': 'Edoardo Vincenzo', 'Initials': 'EV', 'LastName': 'Savarino', 'Affiliation': 'Department of Surgery, Oncology and Gastroenterology (DISCOG), University Hospital of Padua, Padua, Italy.'}]",Neurogastroenterology and motility : the official journal of the European Gastrointestinal Motility Society,['10.1111/nmo.13914']
1184,32484441,Facebook as a Novel Tool for Continuous Professional Education on Dementia: Pilot Randomized Controlled Trial.,"BACKGROUND


Social network sites (SNSs) are widely exploited in health education and communication by the general public, including patients with various conditions. Nevertheless, there is an absence of evidence evaluating SNSs in connecting health professionals for professional purposes.
OBJECTIVE


This pilot randomized controlled trial was designed to evaluate the feasibility of an intervention aiming to investigate the effects of a continuous professional education program utilizing Facebook to obtain knowledge on dementia and care for patients with dementia.
METHODS


Eighty health professionals from Hong Kong were recruited for participation in the study and randomized at a 1:1 ratio by a block randomization method to the intervention group (n=40) and control group (n=40). The intervention was an 8-week educational program developed to deliver updated knowledge on dementia care from a multidisciplinary perspective, either by Facebook (intervention group) or by email (control group) from October 2018 to January 2019. The primary outcomes were the effects of the intervention, measured by differences in the means of changes in pre- and postintervention scores of knowledge assessments from the 25-item Dementia Knowledge Assessment Scale (DKAS) and formative evaluation of 20 multiple choice questions. Other outcome measurements included participant compliance, participant engagement in Facebook, satisfaction, and self-perceived uses of Facebook for continuing professional education programs.
RESULTS


Significantly more intervention group participants (n=35) completed the study than the control group (n=25) (P<.001). The overall retention rate was 75% (60/80). The mean of changes in scores in the intervention group were significant in all assessments (P<.001). A significant difference in the mean of changes in scores between the two groups was identified in the DKAS subscale Communication and Behavior (95% CI 0.4-3.3, P=.02). There was no significant difference in the total DKAS scores, scores of other DKAS subscales, and multiple choice questions. Participant compliance was significantly higher in the intervention group than in the control group (P<.001). The mean numbers of participants accessing the learning materials were 31.5 (SD 3.9) and 17.6 (SD 5.2) in the intervention and control group, respectively. Polls attracted the highest level of participant engagement, followed by videos. Intervention group participants scored significantly higher in favoring the use of Facebook for the continuing education program (P=.03). Overall, participants were satisfied with the interventions (mean score 4 of a total of 5, SD 0.6).
CONCLUSIONS


The significantly higher retention rate, together with the high levels of participant compliance and engagement, demonstrate that Facebook is a promising tool for professional education. Education delivered through Facebook was significantly more effective at improving participants' knowledge of how people with dementia communicate and behave. Participants demonstrated positive attitudes toward utilizing Facebook for professional learning. These findings provide evidence for the feasibility of using Facebook as an intervention delivery tool in a manner that can be rolled out into practical settings.",2020,Intervention group participants scored significantly higher in favoring the use of Facebook for the continuing education program (P=.03).,"['Eighty health professionals from Hong Kong were recruited for participation in the study and randomized at a 1:1 ratio by a block randomization method to the intervention group (n=40) and control group (n=40', 'patients with dementia', 'Continuous Professional Education on Dementia', 'patients with various conditions']","['8-week educational program developed to deliver updated knowledge on dementia care from a multidisciplinary perspective, either by Facebook (intervention group) or by email (control group', 'continuous professional education program utilizing Facebook', 'Facebook']","['total DKAS scores, scores of other DKAS subscales, and multiple choice questions', 'mean numbers of participants accessing the learning materials', 'mean of changes in scores', 'means of changes in pre- and postintervention scores of knowledge assessments from the 25-item Dementia Knowledge Assessment Scale (DKAS) and formative evaluation of 20 multiple choice questions', 'participant compliance, participant engagement in Facebook, satisfaction, and self-perceived uses of Facebook for continuing professional education programs', 'DKAS subscale Communication and Behavior', 'overall retention rate', 'Participant compliance']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0013647', 'cui_str': 'Professional Education'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0013647', 'cui_str': 'Professional Education'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0013647', 'cui_str': 'Professional Education'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}]",,0.081195,Intervention group participants scored significantly higher in favoring the use of Facebook for the continuing education program (P=.03).,"[{'ForeName': 'Windy Sy', 'Initials': 'WS', 'LastName': 'Chan', 'Affiliation': 'School of Health Sciences, Caritas Institute of Higher Education, New Territories, China (Hong Kong).'}, {'ForeName': 'Angela Ym', 'Initials': 'AY', 'LastName': 'Leung', 'Affiliation': 'Centre for Gerontological Nursing, School of Nursing, The Hong Kong Polytechnic University, Kowloon, China (Hong Kong).'}]",Journal of medical Internet research,['10.2196/16772']
1185,32480319,Effectiveness of an app-based cognitive behavioral therapy program for postpartum depression in primary care: A randomized controlled trial.,"OBJECTIVE


The objective of this study was to examine the effect of mobile phone applications (App) based cognitive behavioral therapy (CBT) on postpartum depression.
METHOD


A non-blinded parallel-group randomized controlled trial was conducted. The study population consisted of women attended to three health care centers in Kerman, Iran. Participants were recruited between September and November 2018, and randomized 1:1 to either the intervention group (mobile application access) or control group (no mobile application access). All participants completed the Edinburgh Postnatal Depression Scale (EPDS) at the baseline and 2 months after baseline. Data were analyzed using inferential statistics including chi-square, independent sample t-test, paired t-test and linear regression.
RESULTS


A total of 75 women with an average age of 27 years participated in this study. Before the intervention, there was no statistically significant difference between the EPDS score between the two groups (p > 0.001). However, in the intervention group, the average EPDS score after intervention was 8.18 and in the control group was 15.05, which was statistically significant (p < 0.001).
CONCLUSION


These findings provide proof that providing a CBT program using a mobile application can lead to clinically important improvements in outcomes for mothers who suffer from postpartum depression.",2020,"Before the intervention, there was no statistically significant difference between the EPDS score between the two groups (p > 0.001).","['Participants were recruited between September and November 2018', 'postpartum depression in primary care', 'women attended to three health care centers in Kerman, Iran', 'mothers who suffer from postpartum depression', '75 women with an average age of 27 years participated in this study']","['intervention group (mobile application access) or control group (no mobile application access', 'app-based cognitive behavioral therapy program', 'mobile phone applications (App) based cognitive behavioral therapy (CBT']","['Edinburgh Postnatal Depression Scale (EPDS', 'average EPDS score', 'EPDS score']","[{'cui': 'C0221074', 'cui_str': 'Postpartum depression'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0451144', 'cui_str': 'Edinburgh postnatal depression scale'}, {'cui': 'C3472185', 'cui_str': 'Edinburgh postnatal depression scale score'}]",75.0,0.174326,"Before the intervention, there was no statistically significant difference between the EPDS score between the two groups (p > 0.001).","[{'ForeName': 'Nazanin', 'Initials': 'N', 'LastName': 'Jannati', 'Affiliation': 'Neuroscience Research Center, Institute of Neuropharmacology, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Shahrzad', 'Initials': 'S', 'LastName': 'Mazhari', 'Affiliation': 'Neuroscience Research Center, Institute of Neuropharmacology, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Ahmadian', 'Affiliation': 'Medical Informatics Research Center, Institute for Futures Studies in Health, Kerman University of Medical Sciences, Kerman, Iran. Electronic address: ahmadianle@yahoo.com.'}, {'ForeName': 'Moghaddameh', 'Initials': 'M', 'LastName': 'Mirzaee', 'Affiliation': 'Epidemiology and Biostatistics, Kerman University of Medical Sciences, Kerman, Iran.'}]",International journal of medical informatics,['10.1016/j.ijmedinf.2020.104145']
1186,32487179,The ACCEPT-study: design of an RCT with an active treatment control condition to study the effectiveness of the Dutch version of PEERS® for adolescents with autism spectrum disorder.,"BACKGROUND


Social skills interventions are commonly deployed for adolescents with autism spectrum disorder (ASD). Because effective and appropriate social skills are determined by cultural factors that differ throughout the world, the effectiveness of these interventions relies on a good cultural fit. Therefore, the ACCEPT study examines the effectiveness of the Dutch Program for the Education and Enrichment of Relational Skills (PEERS®) social skills intervention.
METHODS/DESIGN


This study is a two-arm parallel group randomized controlled trial (RCT) in which adolescents are randomly assigned (after baseline assessment) to one of two group interventions (PEERS® vs. active control condition). In total, 150 adolescents are to be included, with multi-informant involvement of their parents and teachers. The ACCEPT study uses an active control condition (puberty psychoeducation group training, focussing on social-emotional development) and explores possible moderators and mediators in improving social skills. The primary outcome measure is the Contextual Assessment of Social Skills (CASS). The CASS assesses social skills performance in a face to face social interaction with an unfamiliar, typically developing peer, making this a valuable instrument to assess the social conversational skills targeted in PEERS®. In addition, to obtain a complete picture of social skills, self-, parent- and teacher-reported social skills are assessed using the Social Skills improvement System (SSiS-RS) and Social Responsiveness Scale (SRS-2). Secondary outcome measures (i.e. explorative mediators) include social knowledge, social cognition, social anxiety, social contacts and feelings of parenting competency of caregivers. Moreover, demographic and diagnostic measures are assessed as potential moderators of treatment effectiveness. Assessments of adolescents, parents, and teachers take place at baseline (week 0), intermediate (week 7), post intervention (week 14), and at follow-up (week 28).
CONCLUSION


This is the first RCT on the effectiveness of the PEERS® parent-assisted curriculum which includes an active control condition. The outcome of social skills is assessed using observational assessments and multi-informant questionnaires. Additionally, factors related to social learning are assessed at several time points, which will enable us to explore potential mediators and moderators of treatment effect.
TRAIL REGISTRATION


Dutch trail register NTR6255 (NL6117). Registered February 8th, 2017 - retrospectively registered.",2020,"Therefore, the ACCEPT study examines the effectiveness of the Dutch Program for the Education and Enrichment of Relational Skills (PEERS®) social skills intervention.
","['adolescents with autism spectrum disorder', 'adolescents with autism spectrum disorder (ASD', '150 adolescents are to be included, with multi-informant involvement of their parents and teachers']","['RCT', 'Dutch version of PEERS®', 'active control condition (puberty psychoeducation group training, focussing on social-emotional development', 'group interventions (PEERS® vs. active control condition']","['social skills performance', 'social skills, self-, parent- and teacher-reported social skills', 'Social Skills improvement System (SSiS-RS) and Social Responsiveness Scale (SRS-2', 'social skills', 'social knowledge, social cognition, social anxiety, social contacts and feelings of parenting competency of caregivers', 'Contextual Assessment of Social Skills (CASS']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0034011', 'cui_str': 'Puberty'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0679005', 'cui_str': 'Social Abilities'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0175693', 'cui_str': 'Russell-Silver syndrome'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C0237101', 'cui_str': 'Social interaction finding'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",,0.0292637,"Therefore, the ACCEPT study examines the effectiveness of the Dutch Program for the Education and Enrichment of Relational Skills (PEERS®) social skills intervention.
","[{'ForeName': 'B J', 'Initials': 'BJ', 'LastName': 'van Pelt', 'Affiliation': 'Department of Child and Adolescent Psychiatry/Psychology, Erasmus MC-Sophia, Wytemaweg 8, 3015, CN, Rotterdam, The Netherlands. b.vanpelt@erasmusmc.nl.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Idris', 'Affiliation': 'Department of Child and Adolescent Psychiatry/Psychology, Erasmus MC-Sophia, Wytemaweg 8, 3015, CN, Rotterdam, The Netherlands.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Jagersma', 'Affiliation': 'Yulius Organization for Mental Health, Burg, De Raadtsingel 93c, 3311, JG, Dordrecht, The Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Duvekot', 'Affiliation': 'Department of Child and Adolescent Psychiatry/Psychology, Erasmus MC-Sophia, Wytemaweg 8, 3015, CN, Rotterdam, The Netherlands.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Maras', 'Affiliation': 'Yulius Organization for Mental Health, Burg, De Raadtsingel 93c, 3311, JG, Dordrecht, The Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'van der Ende', 'Affiliation': 'Department of Child and Adolescent Psychiatry/Psychology, Erasmus MC-Sophia, Wytemaweg 8, 3015, CN, Rotterdam, The Netherlands.'}, {'ForeName': 'N E M', 'Initials': 'NEM', 'LastName': 'van Haren', 'Affiliation': 'Department of Child and Adolescent Psychiatry/Psychology, Erasmus MC-Sophia, Wytemaweg 8, 3015, CN, Rotterdam, The Netherlands.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Greaves-Lord', 'Affiliation': 'Department of Child and Adolescent Psychiatry/Psychology, Erasmus MC-Sophia, Wytemaweg 8, 3015, CN, Rotterdam, The Netherlands.'}]",BMC psychiatry,['10.1186/s12888-020-02650-9']
1187,32485785,"Stem cell mobilization with plerixafor and healing of diabetic ischemic wounds: A phase IIa, randomized, double-blind, placebo-controlled trial.","Bone marrow-derived cells contribute to tissue repair, but traffic of hematopoietic stem/progenitor cells (HSPCs) is impaired in diabetes. We therefore tested whether HSPC mobilization with the CXCR4 antagonist plerixafor improved healing of ischemic diabetic wounds. This was a pilot, phase IIa, double-blind, randomized, placebo-controlled trial (NCT02790957). Patients with diabetes with ischemic wounds were randomized to receive a single subcutaneous injection of plerixafor or saline on top of standard medical and surgical therapy. The primary endpoint was complete healing at 6 months. Secondary endpoints were wound size, transcutaneous oxygen tension (TcO 2  ), ankle-brachial index (ABI), amputations, and HSPC mobilization. Twenty-six patients were enrolled: 13 received plerixafor and 13 received placebo. Patients were 84.6% males, with a mean age of 69 years. HSPC mobilization was successful in all patients who received plerixafor. The trial was terminated after a preplanned interim analysis of 50% of the target population showed a significantly lower healing rate in the plerixafor vs the placebo group. In the final analysis data set, the rate of complete healing was 38.5% in the plerixafor group vs 69.2% in the placebo group (chi-square P = .115). Wound size tended to be larger in the plerixafor group for the entire duration of observation. No significant difference was noted for the change in TcO 2  and ABI or in amputation rates. No other safety concern emerged. In conclusion, successful HSPC mobilization with plerixafor did not improve healing of ischemic diabetic wounds. Contrary to what was expected, outside the context of hematological disorders, mobilization of diabetic HSPCs might exert adverse effects on wound healing.",2020,No significant difference was noted for the change in TcO 2  and ABI or in amputation rates.,"['Twenty-six patients were enrolled: 13 received', 'diabetic ischemic wounds', 'Patients were 84.6% males, with a mean age of 69\u2009years', 'Patients with diabetes with ischemic wounds']","['CXCR4 antagonist plerixafor', 'plerixafor', 'plerixafor or saline', 'placebo']","['HSPC mobilization', 'healing rate', 'healing of ischemic diabetic wounds', 'rate of complete healing', 'Wound size', 'complete healing', 'change in TcO 2  and ABI or in amputation rates', 'wound size, transcutaneous oxygen tension (TcO 2  ), ankle-brachial index (ABI), amputations, and HSPC mobilization']","[{'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C4761249', 'cui_str': 'Ischaemic wound'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C2352110', 'cui_str': 'CXCR4 protein, human'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C1955474', 'cui_str': 'Plerixafor'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C4728046', 'cui_str': 'Diabetic wound'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1863925', 'cui_str': 'Nonmedullary thyroid carcinoma, with or without cell oxyphilia'}, {'cui': 'C1328319', 'cui_str': 'Ankle brachial pressure index'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0202155', 'cui_str': 'Oxygen measurement, partial pressure, arterial'}]",26.0,0.472383,No significant difference was noted for the change in TcO 2  and ABI or in amputation rates.,"[{'ForeName': 'Benedetta Maria', 'Initials': 'BM', 'LastName': 'Bonora', 'Affiliation': 'Department of Medicine, University of Padova, Padova, Italy.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Cappellari', 'Affiliation': 'Department of Medicine, University of Padova, Padova, Italy.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Mazzucato', 'Affiliation': 'Department of Medicine, University of Padova, Padova, Italy.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Rigato', 'Affiliation': 'Department of Medicine, University of Padova, Padova, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Grasso', 'Affiliation': 'Department of Medicine, University of Padova, Padova, Italy.'}, {'ForeName': 'Mirko', 'Initials': 'M', 'LastName': 'Menegolo', 'Affiliation': 'Department of Cardiothoracic and Vascular Sciences, University of Padova, Padova, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Bruttocao', 'Affiliation': 'Department of Medicine, University of Padova, Padova, Italy.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Avogaro', 'Affiliation': 'Department of Medicine, University of Padova, Padova, Italy.'}, {'ForeName': 'Gian Paolo', 'Initials': 'GP', 'LastName': 'Fadini', 'Affiliation': 'Department of Medicine, University of Padova, Padova, Italy.'}]",Stem cells translational medicine,['10.1002/sctm.20-0020']
1188,32586526,Variants in ADRB1 and CYP2C9: Association with Response to Atenolol and Losartan in Marfan Syndrome.,"OBJECTIVE


To test whether variants in ADRB1 and CYP2C9 genes identify subgroups of individuals with differential response to treatment for Marfan syndrome through analysis of data from a large, randomized trial.
STUDY DESIGN


In a subset of 250 white, non-Hispanic participants with Marfan syndrome in a prior randomized trial of atenolol vs losartan, the common variants rs1801252 and rs1801253 in ADRB1 and rs1799853 and rs1057910 in CYP2C9 were analyzed. The primary outcome was baseline-adjusted annual rate of change in the maximum aortic root diameter z-score over 3 years, assessed using mixed effects models.
RESULTS


Among 122 atenolol-assigned participants, the 70 with rs1801253 CC genotype had greater rate of improvement in aortic root z-score compared with 52 participants with CG or GG genotypes (Time × Genotype interaction P = .005, mean annual z-score change ± SE -0.20 ± 0.03 vs -0.09 ± 0.03). Among participants with the CC genotype in both treatment arms, those assigned to atenolol had greater rate of improvement compared with the 71 of the 121 assigned to losartan (interaction P = .002; -0.20 ± 0.02 vs -0.07 ± 0.02; P < .001). There were no differences in atenolol response by rs1801252 genotype or in losartan response by CYP2C9 metabolizer status.
CONCLUSIONS


In this exploratory study, ADRB1-rs1801253 was associated with atenolol response in children and young adults with Marfan syndrome. If these findings are confirmed in future studies, ADRB1 genotyping has the potential to guide therapy by identifying those who are likely to have greater therapeutic response to atenolol than losartan.",2020,"There were no differences in atenolol response by rs1801252 genotype or in losartan response by CYP2C9 metabolizer status.
","['250 white, non-Hispanic participants with Marfan syndrome', 'Marfan Syndrome', 'children and young adults with Marfan syndrome']","['atenolol vs losartan', 'losartan', 'Atenolol and Losartan', 'atenolol']","['atenolol response', 'rate of improvement in aortic root z-score', 'rate of improvement', 'baseline-adjusted annual rate of change in the maximum aortic root diameter z-score over 3\xa0years, assessed using mixed effects models']","[{'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0024796', 'cui_str': ""Marfan's syndrome""}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0004147', 'cui_str': 'Atenolol'}, {'cui': 'C0126174', 'cui_str': 'Losartan'}]","[{'cui': 'C0004147', 'cui_str': 'Atenolol'}, {'cui': 'C0549113', 'cui_str': 'Supraaortic valve area structure'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]",52.0,0.139844,"There were no differences in atenolol response by rs1801252 genotype or in losartan response by CYP2C9 metabolizer status.
","[{'ForeName': 'Sara L', 'Initials': 'SL', 'LastName': 'Van Driest', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center, Nashville, TN; Department of Medicine, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Lynn A', 'Initials': 'LA', 'LastName': 'Sleeper', 'Affiliation': ""Department of Cardiology, Boston Children's Hospital, and Department of Pediatrics, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Bruce D', 'Initials': 'BD', 'LastName': 'Gelb', 'Affiliation': 'Mindich Child Health and Development Institute, Departments of Pediatrics and Genetics & Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Shaine A', 'Initials': 'SA', 'LastName': 'Morris', 'Affiliation': ""Division of Cardiology, Department of Pediatrics, Baylor College of Medicine and Texas Children's Hospital, Houston, TX.""}, {'ForeName': 'Harry C', 'Initials': 'HC', 'LastName': 'Dietz', 'Affiliation': 'Institute of Genetic Medicine, Johns Hopkins University School of Medicine and Howard Hughes Medical Institute, Baltimore, MD.'}, {'ForeName': 'Geoffrey A', 'Initials': 'GA', 'LastName': 'Forbus', 'Affiliation': 'Department of Pediatrics, Division of Pediatric Cardiology, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Goldmuntz', 'Affiliation': ""Division of Cardiology, Children's Hospital of Philadelphia, Department of Pediatrics University of Pennsylvania Perlman School of Medicine, Philadelphia, PA.""}, {'ForeName': 'Arvind', 'Initials': 'A', 'LastName': 'Hoskoppal', 'Affiliation': 'Departments of Pediatrics and Internal Medicine, University of Utah and Intermountain Healthcare, Salt Lake City, UT.'}, {'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'James', 'Affiliation': ""Department of Pediatrics, Section of Cardiology, Medical College of Wisconsin and Children's Hospital of Wisconsin, Milwaukee, WI.""}, {'ForeName': 'Teresa M', 'Initials': 'TM', 'LastName': 'Lee', 'Affiliation': 'Department of Pediatrics, Columbia University Medical Center, New York, NY.'}, {'ForeName': 'Jami C', 'Initials': 'JC', 'LastName': 'Levine', 'Affiliation': ""Department of Cardiology, Boston Children's Hospital, and Department of Pediatrics, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Li', 'Affiliation': 'Department of Pediatrics, Division of Cardiology, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Bart L', 'Initials': 'BL', 'LastName': 'Loeys', 'Affiliation': 'Center of Medical Genetics, Faculty of Medicine and Health Sciences, University of Antwerp and Antwerp University Hospital, Antwerp, Belgium.'}, {'ForeName': 'Larry W', 'Initials': 'LW', 'LastName': 'Markham', 'Affiliation': 'Department of Pediatrics, Division of Pediatric Cardiology, Riley Hospital for Children, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Josephina A N', 'Initials': 'JAN', 'LastName': 'Meester', 'Affiliation': 'Center of Medical Genetics, Faculty of Medicine and Health Sciences, University of Antwerp and Antwerp University Hospital, Antwerp, Belgium.'}, {'ForeName': 'Seema', 'Initials': 'S', 'LastName': 'Mital', 'Affiliation': 'Department of Pediatrics, Division of Cardiology, Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Mosley', 'Affiliation': 'Department of Medicine, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Aaron K', 'Initials': 'AK', 'LastName': 'Olson', 'Affiliation': ""Department of Pediatrics, Seattle Children's Hospital, Seattle, WA.""}, {'ForeName': 'Marjolijn', 'Initials': 'M', 'LastName': 'Renard', 'Affiliation': 'Center for Medical Genetics, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Christian M', 'Initials': 'CM', 'LastName': 'Shaffer', 'Affiliation': 'Department of Medicine, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Sharkey', 'Affiliation': 'Department of Pediatrics, Washington University, St. Louis, MO.'}, {'ForeName': 'Luciana', 'Initials': 'L', 'LastName': 'Young', 'Affiliation': ""Department of Pediatrics, Ann & Robert H. Lurie Children's Hospital, Chicago, IL.""}, {'ForeName': 'Ronald V', 'Initials': 'RV', 'LastName': 'Lacro', 'Affiliation': ""Department of Cardiology, Boston Children's Hospital, and Department of Pediatrics, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Dan M', 'Initials': 'DM', 'LastName': 'Roden', 'Affiliation': 'Department of Medicine, Vanderbilt University Medical Center, Nashville, TN; Departments of Pharmacology and Biomedical Informatics, Vanderbilt University Medical Center, Nashville, TN.'}]",The Journal of pediatrics,['10.1016/j.jpeds.2020.03.064']
1189,32591475,"Natalizumab in acute ischemic stroke (ACTION II): A randomized, placebo-controlled trial.","OBJECTIVE


We evaluated the effect of 2 doses of natalizumab on functional outcomes in patients with acute ischemic stroke (AIS).
METHODS


In this double-blind phase 2b trial, patients with AIS aged 18-80 years with NIH Stroke Scale scores of 5-23 from 53 US and European sites were randomized 1:1:1 to receive a single dose of 300 or 600 mg IV natalizumab or placebo, with randomization stratified by treatment window (≤9 or >9 to ≤24 hours from patient's last known normal state). The primary endpoint was a composite measure of excellent outcome (modified Rankin Scale score ≤1 and Barthel Index score ≥95) at day 90 assessed in all patients receiving a full dose. Sample size was estimated from a Bayesian model;  p  values were not used for hypothesis testing.
RESULTS


An excellent outcome was less likely with natalizumab than with placebo (natalizumab 300 or 600 mg odds ratio 0.60; 95% confidence interval 0.39-0.93). There was no effect modification by time to treatment or use of thrombolysis/thrombectomy. For natalizumab 300 mg, 600 mg, or placebo, there were no differences in incidence of adverse events (90.0%, 92.1%, and 92.3%, respectively), serious adverse events (25.6%, 32.6%, and 20.9%, respectively), or deaths (6.7%, 4.5%, and 5.5%, respectively).
CONCLUSIONS


Natalizumab administered ≤24 hours after AIS did not improve patient outcomes.
CLINICALTRIALSGOV IDENTIFIER


NCT02730455 CLASSIFICATION OF EVIDENCE: This study provides Class I evidence that for patients with AIS, an excellent outcome was less likely in patients treated with natalizumab than with placebo.",2020,An excellent outcome was less likely with natalizumab than with placebo (natalizumab 300 mg or 600 mg odds ratio 0.60; 95% confidence interval 0.39-0.93).,"['patients with AIS', 'acute ischemic stroke (AIS) patients', 'AIS patients aged 18-80 years with National Institutes of Health Stroke Scale scores of 5-23 from 53 US and European sites']","['Natalizumab', 'placebo (natalizumab', 'natalizumab or placebo, with randomization stratified by treatment window ', 'natalizumab', 'placebo']","['serious adverse events', 'deaths', 'patient outcomes', 'composite measure of excellent outcome (modified Rankin Scale score ≤1 and Barthel Index score ≥95', 'incidence of adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205145', 'cui_str': 'Site'}]","[{'cui': 'C1172734', 'cui_str': 'natalizumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0557702', 'cui_str': 'Window'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1961136', 'cui_str': 'Excellent'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",,0.783971,An excellent outcome was less likely with natalizumab than with placebo (natalizumab 300 mg or 600 mg odds ratio 0.60; 95% confidence interval 0.39-0.93).,"[{'ForeName': 'Mitchell S V', 'Initials': 'MSV', 'LastName': 'Elkind', 'Affiliation': ""From Columbia University (M.S.V.E.), New York, NY; Imperial College London (R.V.), UK; Alfried-Krupp Krankenhaus (R.V.), Essen, Germany; Vall d'Hebron Research Institute (VHIR) (J.M.), Barcelona; Institute of Biomedicine of Seville (IBiS) Stroke Programme (J.M.), Spain; University of Texas (S.C.J.), Austin; Massachusetts General Hospital (A.B.S.), Boston; University of Washington (K.B.), Seattle; Stanford University Medical Center (M.G.L.), Stanford Stroke Center, CA; and Biogen (W.T., R.K., J.E.), Cambridge, MA. mse13@columbia.edu.""}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Veltkamp', 'Affiliation': ""From Columbia University (M.S.V.E.), New York, NY; Imperial College London (R.V.), UK; Alfried-Krupp Krankenhaus (R.V.), Essen, Germany; Vall d'Hebron Research Institute (VHIR) (J.M.), Barcelona; Institute of Biomedicine of Seville (IBiS) Stroke Programme (J.M.), Spain; University of Texas (S.C.J.), Austin; Massachusetts General Hospital (A.B.S.), Boston; University of Washington (K.B.), Seattle; Stanford University Medical Center (M.G.L.), Stanford Stroke Center, CA; and Biogen (W.T., R.K., J.E.), Cambridge, MA.""}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Montaner', 'Affiliation': ""From Columbia University (M.S.V.E.), New York, NY; Imperial College London (R.V.), UK; Alfried-Krupp Krankenhaus (R.V.), Essen, Germany; Vall d'Hebron Research Institute (VHIR) (J.M.), Barcelona; Institute of Biomedicine of Seville (IBiS) Stroke Programme (J.M.), Spain; University of Texas (S.C.J.), Austin; Massachusetts General Hospital (A.B.S.), Boston; University of Washington (K.B.), Seattle; Stanford University Medical Center (M.G.L.), Stanford Stroke Center, CA; and Biogen (W.T., R.K., J.E.), Cambridge, MA.""}, {'ForeName': 'S Claiborne', 'Initials': 'SC', 'LastName': 'Johnston', 'Affiliation': ""From Columbia University (M.S.V.E.), New York, NY; Imperial College London (R.V.), UK; Alfried-Krupp Krankenhaus (R.V.), Essen, Germany; Vall d'Hebron Research Institute (VHIR) (J.M.), Barcelona; Institute of Biomedicine of Seville (IBiS) Stroke Programme (J.M.), Spain; University of Texas (S.C.J.), Austin; Massachusetts General Hospital (A.B.S.), Boston; University of Washington (K.B.), Seattle; Stanford University Medical Center (M.G.L.), Stanford Stroke Center, CA; and Biogen (W.T., R.K., J.E.), Cambridge, MA.""}, {'ForeName': 'Aneesh B', 'Initials': 'AB', 'LastName': 'Singhal', 'Affiliation': ""From Columbia University (M.S.V.E.), New York, NY; Imperial College London (R.V.), UK; Alfried-Krupp Krankenhaus (R.V.), Essen, Germany; Vall d'Hebron Research Institute (VHIR) (J.M.), Barcelona; Institute of Biomedicine of Seville (IBiS) Stroke Programme (J.M.), Spain; University of Texas (S.C.J.), Austin; Massachusetts General Hospital (A.B.S.), Boston; University of Washington (K.B.), Seattle; Stanford University Medical Center (M.G.L.), Stanford Stroke Center, CA; and Biogen (W.T., R.K., J.E.), Cambridge, MA.""}, {'ForeName': 'Kyra', 'Initials': 'K', 'LastName': 'Becker', 'Affiliation': ""From Columbia University (M.S.V.E.), New York, NY; Imperial College London (R.V.), UK; Alfried-Krupp Krankenhaus (R.V.), Essen, Germany; Vall d'Hebron Research Institute (VHIR) (J.M.), Barcelona; Institute of Biomedicine of Seville (IBiS) Stroke Programme (J.M.), Spain; University of Texas (S.C.J.), Austin; Massachusetts General Hospital (A.B.S.), Boston; University of Washington (K.B.), Seattle; Stanford University Medical Center (M.G.L.), Stanford Stroke Center, CA; and Biogen (W.T., R.K., J.E.), Cambridge, MA.""}, {'ForeName': 'Maarten G', 'Initials': 'MG', 'LastName': 'Lansberg', 'Affiliation': ""From Columbia University (M.S.V.E.), New York, NY; Imperial College London (R.V.), UK; Alfried-Krupp Krankenhaus (R.V.), Essen, Germany; Vall d'Hebron Research Institute (VHIR) (J.M.), Barcelona; Institute of Biomedicine of Seville (IBiS) Stroke Programme (J.M.), Spain; University of Texas (S.C.J.), Austin; Massachusetts General Hospital (A.B.S.), Boston; University of Washington (K.B.), Seattle; Stanford University Medical Center (M.G.L.), Stanford Stroke Center, CA; and Biogen (W.T., R.K., J.E.), Cambridge, MA.""}, {'ForeName': 'Weihua', 'Initials': 'W', 'LastName': 'Tang', 'Affiliation': ""From Columbia University (M.S.V.E.), New York, NY; Imperial College London (R.V.), UK; Alfried-Krupp Krankenhaus (R.V.), Essen, Germany; Vall d'Hebron Research Institute (VHIR) (J.M.), Barcelona; Institute of Biomedicine of Seville (IBiS) Stroke Programme (J.M.), Spain; University of Texas (S.C.J.), Austin; Massachusetts General Hospital (A.B.S.), Boston; University of Washington (K.B.), Seattle; Stanford University Medical Center (M.G.L.), Stanford Stroke Center, CA; and Biogen (W.T., R.K., J.E.), Cambridge, MA.""}, {'ForeName': 'Rachna', 'Initials': 'R', 'LastName': 'Kasliwal', 'Affiliation': ""From Columbia University (M.S.V.E.), New York, NY; Imperial College London (R.V.), UK; Alfried-Krupp Krankenhaus (R.V.), Essen, Germany; Vall d'Hebron Research Institute (VHIR) (J.M.), Barcelona; Institute of Biomedicine of Seville (IBiS) Stroke Programme (J.M.), Spain; University of Texas (S.C.J.), Austin; Massachusetts General Hospital (A.B.S.), Boston; University of Washington (K.B.), Seattle; Stanford University Medical Center (M.G.L.), Stanford Stroke Center, CA; and Biogen (W.T., R.K., J.E.), Cambridge, MA.""}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Elkins', 'Affiliation': ""From Columbia University (M.S.V.E.), New York, NY; Imperial College London (R.V.), UK; Alfried-Krupp Krankenhaus (R.V.), Essen, Germany; Vall d'Hebron Research Institute (VHIR) (J.M.), Barcelona; Institute of Biomedicine of Seville (IBiS) Stroke Programme (J.M.), Spain; University of Texas (S.C.J.), Austin; Massachusetts General Hospital (A.B.S.), Boston; University of Washington (K.B.), Seattle; Stanford University Medical Center (M.G.L.), Stanford Stroke Center, CA; and Biogen (W.T., R.K., J.E.), Cambridge, MA.""}]",Neurology,['10.1212/WNL.0000000000010038']
1190,32594135,Co-administration of 5α-reductase Inhibitors Worsens the Adverse Metabolic Effects of Prescribed Glucocorticoids.,"CONTEXT


Glucocorticoids (GCs) are commonly prescribed, but their use is associated with adverse metabolic effects. 5α-reductase inhibitors (5α-RI) are also frequently prescribed, mainly to inhibit testosterone conversion to dihydrotestosterone. However, they also prevent the inactivation of GCs.
OBJECTIVE


We hypothesized that 5α-RI may worsen the adverse effects of GCs.
DESIGN


Prospective, randomized study.
PATIENTS


A total of 19 healthy male volunteers (age 45 ± 2 years; body mass index 27.1 ± 0.7kg/m2).
INTERVENTIONS


Participants underwent metabolic assessments; 2-step hyperinsulinemic, euglycemic clamp incorporating stable isotopes, adipose tissue microdialysis, and biopsy. Participants were then randomized to either prednisolone (10 mg daily) or prednisolone (10 mg daily) plus a 5α-RI (finasteride 5 mg daily or dutasteride 0.5 mg daily) for 7 days; metabolic assessments were then repeated.
MAIN OUTCOME MEASURES


Ra glucose, glucose utilization (M-value), glucose oxidation, and nonesterified fatty acids (NEFA) levels.
RESULTS


Co-administration of prednisolone with a 5α-RI increased circulating prednisolone levels (482 ± 96 vs 761 ± 57 nmol/L, P = 0.029). Prednisolone alone did not alter Ra glucose (2.55 ± 0.34 vs 2.62 ± 0.19 mg/kg/minute, P = 0.86), M-value (3.2 ± 0.5 vs 2.7 ± 0.7 mg/kg/minute, P = 0.37), or glucose oxidation (0.042 ± 0.007 vs 0.040 ± 0.004 mmol/hr/kg/minute, P = 0.79). However, co-administration with a 5α-RI increased Ra glucose (2.67 ± 0.16 vs 3.05 ± 0.18 mg/kg/minute, P < 0.05) and decreased M-value (4.0 ± 0.5 vs 2.6 ± 0.4 mg/kg/minute, P < 0.05), and oxidation (0.043 ± 0.003 vs 0.036 ± 0.002 mmol/hr/kg, P < 0.01). Similarly, prednisolone did not impair insulin-mediated suppression of circulating NEFA (43.1 ± 28.9 vs 36.8 ± 14.3 μmol/L, P = 0.81), unless co-administered with a 5α-RI (49.8 ± 8.6 vs 88.5 ± 13.5 μmol/L, P < 0.01).
CONCLUSIONS


We have demonstrated that 5α-RIs exacerbate the adverse effects of prednisolone. This study has significant translational implications, including the need to consider GC dose adjustments, but also the necessity for increased vigilance for the development of adverse effects.",2020,"Similarly, prednisolone did not impair insulin-mediated suppression of circulating NEFA (43.1±28.9 vs. 36.8±14.3μmol/L, p=0.81), unless co-administered with a 5aRI (49.8±8.6 vs. 88.5±13.5μmol/L, p<0.01).
","['19 healthy male volunteers (age; 45±2 years, BMI; 27.1±0.7kg/m2']","['5α-reductase inhibitors', '5aRI (finasteride 5mg daily or dutasteride', 'hyperinsulinemic, euglycemic clamp incorporating stable-isotopes, adipose tissue microdialysis and biopsy', 'Prednisolone', 'prednisolone']","['adverse metabolic effects', 'M-value', 'Ra glucose', 'Ra glucose, glucose utilization (M-value), glucose oxidation, non-esterified fatty acids (NEFA) levels', 'circulating prednisolone levels', 'glucose oxidation', 'insulin-mediated suppression of circulating NEFA']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0030016', 'cui_str': 'Oxidoreductase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0986066', 'cui_str': 'Finasteride 5 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0754659', 'cui_str': 'Dutasteride'}, {'cui': 'C0079318', 'cui_str': 'Euglycaemic Clamp'}, {'cui': 'C0302918', 'cui_str': 'Stable isotope'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0206056', 'cui_str': 'Microdialysis'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}]","[{'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0369212', 'cui_str': 'Esterified fatty acid'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}]",19.0,0.0933746,"Similarly, prednisolone did not impair insulin-mediated suppression of circulating NEFA (43.1±28.9 vs. 36.8±14.3μmol/L, p=0.81), unless co-administered with a 5aRI (49.8±8.6 vs. 88.5±13.5μmol/L, p<0.01).
","[{'ForeName': 'Nantia', 'Initials': 'N', 'LastName': 'Othonos', 'Affiliation': 'Oxford Centre for Diabetes, Endocrinology and Metabolism, NIHR Oxford Biomedical Research Centre, University of Oxford, Churchill Hospital, Oxford, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Marjot', 'Affiliation': 'Translational Gastroenterology Unit, NIHR Oxford Biomedical Research Centre, University of Oxford, John Radcliffe Hospital, Oxford, UK.'}, {'ForeName': 'Conor', 'Initials': 'C', 'LastName': 'Woods', 'Affiliation': 'Department of Endocrinology, Naas General Hospital, Kildare and Tallaght Hospital, Dublin, Ireland.'}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Hazlehurst', 'Affiliation': 'Institute of Metabolism and Systems Research, University of Birmingham, Edgbaston, Birmingham, UK.'}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Nikolaou', 'Affiliation': 'Oxford Centre for Diabetes, Endocrinology and Metabolism, NIHR Oxford Biomedical Research Centre, University of Oxford, Churchill Hospital, Oxford, UK.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Pofi', 'Affiliation': 'Department of Experimental Medicine, Sapienza University of Rome, Rome, 00161, Italy.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'White', 'Affiliation': 'Oxford Centre for Diabetes, Endocrinology and Metabolism, NIHR Oxford Biomedical Research Centre, University of Oxford, Churchill Hospital, Oxford, UK.'}, {'ForeName': 'Ilaria', 'Initials': 'I', 'LastName': 'Bonaventura', 'Affiliation': 'Department of Experimental Medicine, Sapienza University of Rome, Rome, 00161, Italy.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Webster', 'Affiliation': 'Department of Pathology, University Hospitals Birmingham, NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Duffy', 'Affiliation': 'Department of Pathology, University Hospitals Birmingham, NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Cornfield', 'Affiliation': 'Oxford Centre for Diabetes, Endocrinology and Metabolism, NIHR Oxford Biomedical Research Centre, University of Oxford, Churchill Hospital, Oxford, UK.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Moolla', 'Affiliation': 'Oxford Centre for Diabetes, Endocrinology and Metabolism, NIHR Oxford Biomedical Research Centre, University of Oxford, Churchill Hospital, Oxford, UK.'}, {'ForeName': 'Andrea M', 'Initials': 'AM', 'LastName': 'Isidori', 'Affiliation': 'Department of Experimental Medicine, Sapienza University of Rome, Rome, 00161, Italy.'}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Hodson', 'Affiliation': 'Oxford Centre for Diabetes, Endocrinology and Metabolism, NIHR Oxford Biomedical Research Centre, University of Oxford, Churchill Hospital, Oxford, UK.'}, {'ForeName': 'Jeremy W', 'Initials': 'JW', 'LastName': 'Tomlinson', 'Affiliation': 'Oxford Centre for Diabetes, Endocrinology and Metabolism, NIHR Oxford Biomedical Research Centre, University of Oxford, Churchill Hospital, Oxford, UK.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa408']
1191,32476057,The impact of employment on recovery among individuals who are homeless with severe mental illness in the Vancouver At Home/Chez Soi trial.,"OBJECTIVE


To assess impact of employment on recovery in a sample of adults from Vancouver At Home (VAH) study, who were homeless and were diagnosed with severe mental disorders.
METHODS


The VAH included two randomized controlled trials investigating the effect of housing first with support intervention in vulnerable population. Employment was assessed at baseline and during the follow-up using Demographics, Housing, Vocational, and Service Use History (DSHH), and Vocational Timeline Follow-Back (VTLFB) self-report questionnaires, respectively. Recovery was examined using Recovery Assessment Scale (RAS) at baseline and at 24-month follow-up visit. Multivariable regression models were built to examine: (1) the effect of current employment at baseline on RAS score at baseline, and RAS score at 24-month follow-up visit; and (2) and to examine the cumulative effect of recent employment over 8 follow-up visits on RAS score at 24-month visit. Cumulative effect of employment over the follow-up visits was weighted by recency using a pre-specified weighting function.
RESULTS


Employment at baseline was associated with an increase in recovery score at baseline [8.06 (95% CI 1.21, 14.91); p = 0.02], but not with recovery score at 24-month follow-up visit [3.78 (-4.67, 12.24); p = 0.37]. Weighted cumulative effect of employment over 8 follow-up visits was associated with increase in RAS score at 24-month follow-up visit [8.33 (1.68, 14.99) p = 0.01].
CONCLUSION


Employment is associated with an increase in recovery. Our result suggests a dual effect of employment on recovery, an immediate effect through current employment, and a long-term effect of cumulative employment.",2020,"Weighted cumulative effect of employment over 8 follow-up visits was associated with increase in RAS score at 24-month follow-up visit [8.33 (1.68, 14.99) p = 0.01].
","['sample of adults from Vancouver At Home (VAH) study, who were homeless and were diagnosed with severe mental disorders', 'individuals who are homeless with severe mental illness in the Vancouver', 'vulnerable population']",['housing first with support intervention'],"['recovery score', 'recovery', 'RAS score at baseline, and RAS score', 'Demographics, Housing, Vocational, and Service Use History (DSHH), and Vocational Timeline Follow-Back (VTLFB) self-report questionnaires', 'Recovery Assessment Scale (RAS', 'RAS score']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0237154', 'cui_str': 'Homeless'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C4046029', 'cui_str': 'Mental Disorders, Severe'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0949366', 'cui_str': 'Vulnerable Populations'}]","[{'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0145943', 'cui_str': 'TimeLine'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.178522,"Weighted cumulative effect of employment over 8 follow-up visits was associated with increase in RAS score at 24-month follow-up visit [8.33 (1.68, 14.99) p = 0.01].
","[{'ForeName': 'Kiana', 'Initials': 'K', 'LastName': 'Yazdani', 'Affiliation': 'Addiction and Concurrent Disorders Group, Department of Psychiatry, Faculty of Medicine, Institute of Mental Health, University of British Columbia, Vancouver, Canada. kia_yzd@yahoo.com.'}, {'ForeName': 'Mohammadali', 'Initials': 'M', 'LastName': 'Nikoo', 'Affiliation': 'Addiction and Concurrent Disorders Group, Centre for Health Evaluation Outcome Sciences, Department of Psychiatry, Faculty of Medicine, Institute of Mental Health, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Eric C', 'Initials': 'EC', 'LastName': 'Sayre', 'Affiliation': 'Arthritis Research Canada, Richmond, BC, Canada.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Choi', 'Affiliation': 'Addiction and Concurrent Disorders Group, Centre for Health Evaluation Outcome Sciences, Department of Psychiatry, Faculty of Medicine, Institute of Mental Health, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Kerry', 'Initials': 'K', 'LastName': 'Jang', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine, Institute of Mental Health, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Reinhard Michael', 'Initials': 'RM', 'LastName': 'Krausz', 'Affiliation': 'Addiction and Concurrent Disorders Group, Centre for Health Evaluation Outcome Sciences, Department of Psychiatry, Faculty of Medicine, Institute of Mental Health, University of British Columbia, Vancouver, Canada.'}]",Social psychiatry and psychiatric epidemiology,['10.1007/s00127-020-01887-9']
1192,32483056,Acupuncture of different treatment frequencies in knee osteoarthritis: a pilot randomised controlled trial.,"This 16-week randomised controlled trial (8-week treatment followed by 8-week follow-up) evaluated the symptomatic improvement in patients with knee osteoarthritis on 3 sessions per week of acupuncture (TSWA) compared to 1 session per week of acupuncture (OSWA). Sixty participants were randomised to either the TSWA or the OSWA group in a 1:1 ratio. The primary outcome was response rate, defined as the percentage of participants achieving ≥2 points decrease on the numerical rating scale (NRS) and ≥6 points decrease in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function score at week 8 compared with baseline. Additional outcomes included response rates at weeks 4 and 16, NRS, WOMAC, Patient Global Assessment, 12-item Short Form Health Survey (SF-12), and treatment credibility and expectancy. No significant difference was seen in response rate between TSWA and OSWA groups at week 8 (64.7% vs 50.0%; difference, 14.7 percentage points [95% CI, -10.1 to 39.4 percentage points], P = 0.435). At weeks 4 and 16, the TSWA group had higher response rates than the OSWA group (week-4: difference, 44.7 percentage points [95% CI, 23.2-66.1 percentage points], P = 0.001; week-16: difference, 46.0 percentage points [95% CI, 24.4-67.6 percentage points], P < 0.001). Participants in the TSWA group experienced significantly greater improvements in NRS, WOMAC function, and Patient Global Assessment than those in the OSWA group. There were no significant between-group differences in WOMAC stiffness and SF-12. In summary, TSWA immediately improved knee pain and dysfunction compared with OSWA. In addition, the benefit of TSWA persists throughout follow-up.",2020,"Participants in TSWA group experienced significantly greater improvements in NRS, WOMAC function and PGA than OSWA group.","['knee osteoarthritis', 'Sixty participants', 'patients with knee osteoarthritis (KOA']","['OSWA', 'acupuncture (OSWA', 'Acupuncture', 'TSWA', 'acupuncture (TSWA']","['response rate, defined as the percentage of participants achieving ≥2 points decrease on the numerical rating scale (NRS) and ≥6 points decrease in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function score', 'response rates', 'response rates at weeks 4 and 16, NRS, WOMAC, Patient Global Assessment (PGA), 12-item', 'knee pain and dysfunction', 'NRS, WOMAC function and PGA', 'response rate', 'WOMAC stiffness and SF-12']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}]","[{'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}]",60.0,0.126622,"Participants in TSWA group experienced significantly greater improvements in NRS, WOMAC function and PGA than OSWA group.","[{'ForeName': 'Lu-Lu', 'Initials': 'LL', 'LastName': 'Lin', 'Affiliation': 'Acupuncture Research Center, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Jian-Feng', 'Initials': 'JF', 'LastName': 'Tu', 'Affiliation': 'Department of Acupuncture and Moxibustion, Beijing Hospital of Traditional Chinese Medicine, affiliated with Capital Medical University, Beijing, China.'}, {'ForeName': 'Li-Qiong', 'Initials': 'LQ', 'LastName': 'Wang', 'Affiliation': 'Acupuncture Research Center, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Jing-Wen', 'Initials': 'JW', 'LastName': 'Yang', 'Affiliation': 'Acupuncture Research Center, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Guang-Xia', 'Initials': 'GX', 'LastName': 'Shi', 'Affiliation': 'Acupuncture Research Center, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Jin-Ling', 'Initials': 'JL', 'LastName': 'Li', 'Affiliation': 'Acupuncture Research Center, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Zhang', 'Affiliation': 'Acupuncture Research Center, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Jia-Kai', 'Initials': 'JK', 'LastName': 'Shao', 'Affiliation': 'Department of Acupuncture and Moxibustion, Beijing Hospital of Traditional Chinese Medicine, affiliated with Capital Medical University, Beijing, China.'}, {'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'Zou', 'Affiliation': 'Acupuncture Research Center, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Cun-Zhi', 'Initials': 'CZ', 'LastName': 'Liu', 'Affiliation': 'Acupuncture Research Center, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China.'}]",Pain,['10.1097/j.pain.0000000000001940']
1193,32479591,Effect of an integrated care model for pre-frail and frail older people living in community.,"OBJECTIVES


to evaluate the effect of an integrated care model for pre-frail and frail community-dwelling older people.
DESIGN


a quasi-experimental design.
SETTING AND PARTICIPANTS


we enrolled people aged ≥60 years from a community care project. An inclusion criterion was pre-frailty/frailty, as measured by a simple frailty questionnaire (FRAIL) with a score of ≥1.
METHODS


we assigned participants to an intervention group (n = 183) in which they received an integrated intervention (in-depth assessment, personalised care plans and coordinated care) or a control group (n = 270) in which they received a group education session on frailty prevention. The outcomes were changes in frailty, individual domains of frailty ('fatigue', 'resistance', 'ambulation', 'illnesses' and 'loss of weight') and health services utilisation over 12 months. Assessments were conducted at baseline and at the 12-month follow-up.
RESULTS


the mean age of the participants (n = 453) at baseline was 76.1 ± 7.5 years, and 363 (80.1%) were women. At follow-up, the intervention group showed significantly greater reductions in FRAIL scores than the control group (P < 0.033). In addition, 22.4% of the intervention and 13.7% of the control participants had reverted from pre-frail/frail to robust status, with the difference reaching significance when the intervention was compared with the control group (odds ratio [OR] 1.6, 95% confidence interval [CI] 1.0-2.4) after adjustments for age, sex, living arrangement/marital status and hypercholesterolemia. For individual domains of frailty, the adjusted OR for improved 'resistance' was 1.7 (95% CI 1.0-2.8). However, no effects were found on reducing use of health services.
CONCLUSION


the integrated health and social care model reduced FRAIL scores in a combined population of pre-frail/frail community-dwelling older people attending older people's centres.",2020,"At follow-up, the intervention group showed significantly greater reductions in FRAIL scores than the control group (P < 0.033).","['pre-frail and frail community-dwelling older people', 'enrolled people aged ≥60\xa0years from a community care project', ""combined population of pre-frail/frail community-dwelling older people attending older people's centres"", 'the mean age of the participants (n\u2009=\u2009453) at baseline was 76.1\u2009±\u20097.5\xa0years, and 363 (80.1%) were women', 'pre-frail and frail older people living in community']","['integrated care model', 'intervention group (n\u2009=\u2009183) in which they received an integrated intervention (in-depth assessment, personalised care plans and coordinated care) or a control group (n\u2009=\u2009270) in which they received a group education session on frailty prevention']","['FRAIL scores', ""changes in frailty, individual domains of frailty ('fatigue', 'resistance', 'ambulation', 'illnesses' and 'loss of weight') and health services utilisation""]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}]","[{'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517615', 'cui_str': '183'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0178916', 'cui_str': 'Care plan'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4319603', 'cui_str': '270'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}]","[{'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0018747', 'cui_str': 'Services, Health'}]",,0.0395423,"At follow-up, the intervention group showed significantly greater reductions in FRAIL scores than the control group (P < 0.033).","[{'ForeName': 'Ruby', 'Initials': 'R', 'LastName': 'Yu', 'Affiliation': 'Jockey Club Institute of Ageing, The Chinese University of Hong Kong, Hong Kong, SAR, China.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Tong', 'Affiliation': 'Jockey Club Institute of Ageing, The Chinese University of Hong Kong, Hong Kong, SAR, China.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Woo', 'Affiliation': 'Jockey Club Institute of Ageing, The Chinese University of Hong Kong, Hong Kong, SAR, China.'}]",Age and ageing,['10.1093/ageing/afaa087']
1194,32487236,"A randomized, crossover comparison of ketamine and electroconvulsive therapy for treatment of major depressive episodes: a Canadian biomarker integration network in depression (CAN-BIND) study protocol.","BACKGROUND


Recent evidence underscores the utility of rapid-acting antidepressant interventions, such as ketamine, in alleviating symptoms of major depressive episodes (MDE). However, to date, there have been limited head-to-head comparisons of intravenous (IV) ketamine infusions with other antidepressant treatment strategies in large randomized trials. This study protocol describes an ongoing multi-centre, prospective, randomized, crossover, non-inferiority trial comparing acute treatment of individuals meeting diagnostic criteria for a major depressive episode (MDE) with ketamine and electroconvulsive therapy (ECT) on efficacy, speed of therapeutic effects, side effects, and health care resource utilization. A secondary aim is to compare a 6-month maintenance strategy for ketamine responders to standard of care ECT maintenance. Finally, through the measurement of clinical, cognitive, neuroimaging, and molecular markers we aim to establish predictors and moderators of treatment response as well as treatment-elicited effects on these outcomes.
METHODS


Across four participating Canadian institutions, 240 patients with major depressive disorder or bipolar disorder experiencing a MDE are randomized (1:1) to a course of ECT or racemic IV ketamine (0.5 mg/kg) administered 3 times/week for 3 or 4 weeks. Non-responders (< 50% improvement in Montgomery-Åsberg Depression Rating Scale [MADRS] scores) crossover to receive the alternate treatment. Responders during the randomization or crossover phases then enter the 6-month maintenance phase during which time they receive clinical assessments at identical intervals regardless of treatment arm. ECT maintenance follows standard of care while ketamine maintenance involves: weekly infusions for 1 month, then bi-weekly infusions for 2 months, and finally monthly infusions for 3 months (returning to bi-weekly in case of relapse). The primary outcome measure is change in MADRS scores after randomized treatment as assessed by raters blind to treatment modality.
DISCUSSION


This multi-centre study will help identify molecular, imaging, and clinical characteristics of patients with treatment-resistant and/or severe MDEs who would benefit most from either type of therapeutic strategy. In addition to informing clinical practice and influencing health care delivery, this trial will add to the robust platform and database of CAN-BIND studies for future research and biomarker discovery.
TRIAL REGISTRATION


ClinicalTrials.gov identifier NCT03674671. Registered September 17, 2018.",2020,Non-responders (< 50% improvement in Montgomery-Åsberg Depression Rating Scale [MADRS] scores),"['individuals meeting diagnostic criteria for a major depressive episode (MDE) with', 'major depressive episodes', 'patients with treatment-resistant and/or severe MDEs who would benefit most from either type of therapeutic strategy', '240 patients with major depressive disorder or bipolar disorder experiencing a MDE']","['ketamine and electroconvulsive therapy', 'ketamine and electroconvulsive therapy (ECT', 'ketamine', 'ECT or racemic IV ketamine']","['Montgomery-Åsberg Depression Rating Scale [MADRS] scores', 'change in MADRS scores']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0024517', 'cui_str': 'Major depression, single episode'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0047006', 'cui_str': 'Methylenedioxyethylamphetamine'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",240.0,0.221186,Non-responders (< 50% improvement in Montgomery-Åsberg Depression Rating Scale [MADRS] scores),"[{'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Phillips', 'Affiliation': ""The Royal's Institute of Mental Health Research, 1145 Carling Avenue, Ottawa, ON, K1Z 7K4, Canada. Jennifer.Phillips@theroyal.ca.""}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Jaworska', 'Affiliation': ""The Royal's Institute of Mental Health Research, 1145 Carling Avenue, Ottawa, ON, K1Z 7K4, Canada.""}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Kamler', 'Affiliation': ""The Royal's Institute of Mental Health Research, 1145 Carling Avenue, Ottawa, ON, K1Z 7K4, Canada.""}, {'ForeName': 'Venkat', 'Initials': 'V', 'LastName': 'Bhat', 'Affiliation': 'University Health Network, 399 Bathurst Street, Toronto, ON, M5T 2S8, Canada.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Blier', 'Affiliation': 'Montfort Hospital, 713 Montreal Rd, Ottawa, ON, K1K 0T2, Canada.'}, {'ForeName': 'Jane A', 'Initials': 'JA', 'LastName': 'Foster', 'Affiliation': 'University Health Network, 399 Bathurst Street, Toronto, ON, M5T 2S8, Canada.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Hassel', 'Affiliation': 'Department of Psychiatry and Mathison Centre for Mental Health Research and Education, Cumming School of Medicine, University of Calgary, 3330 Hospital Dr NW, Calgary, AB, T2N 4N1, Canada.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Ho', 'Affiliation': 'University Health Network, 399 Bathurst Street, Toronto, ON, M5T 2S8, Canada.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'McMurray', 'Affiliation': 'Department of Psychiatry, University of Ottawa, 1145 Carling Avenue, Ottawa, ON, K1Z 7K4, Canada.'}, {'ForeName': 'Roumen', 'Initials': 'R', 'LastName': 'Milev', 'Affiliation': ""Department of Psychiatry, Queen's University, Providence Care Hospital, 752 King Street West, Postal Bag 603, Kingston, ON, K7L 7X3, Canada.""}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Moazamigoudarzi', 'Affiliation': 'University Health Network, 399 Bathurst Street, Toronto, ON, M5T 2S8, Canada.'}, {'ForeName': 'Franca M', 'Initials': 'FM', 'LastName': 'Placenza', 'Affiliation': 'University Health Network, 399 Bathurst Street, Toronto, ON, M5T 2S8, Canada.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Richard-Devantoy', 'Affiliation': 'McGill University, 845 Rue Sherbrooke O, Montréal, QC, H3A 0G4, Canada.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Rotzinger', 'Affiliation': 'University Health Network, 399 Bathurst Street, Toronto, ON, M5T 2S8, Canada.'}, {'ForeName': 'Gustavo', 'Initials': 'G', 'LastName': 'Turecki', 'Affiliation': 'McGill University, 845 Rue Sherbrooke O, Montréal, QC, H3A 0G4, Canada.'}, {'ForeName': 'Gustavo H', 'Initials': 'GH', 'LastName': 'Vazquez', 'Affiliation': ""Department of Psychiatry, Queen's University, Providence Care Hospital, 752 King Street West, Postal Bag 603, Kingston, ON, K7L 7X3, Canada.""}, {'ForeName': 'Sidney H', 'Initials': 'SH', 'LastName': 'Kennedy', 'Affiliation': 'University Health Network, 399 Bathurst Street, Toronto, ON, M5T 2S8, Canada.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Blier', 'Affiliation': ""The Royal's Institute of Mental Health Research, 1145 Carling Avenue, Ottawa, ON, K1Z 7K4, Canada.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMC psychiatry,['10.1186/s12888-020-02672-3']
1195,32485778,Whole-body Electromyostimulation plus Caloric Restriction in Metabolic Syndrome.,"We investigated early effects of Whole-Body Electromyostimulation added to hypocaloric diet on metabolic syndrome features in sedentary middle-aged individuals. We randomly assigned 25 patients to Whole-Body Electromyostimulation plus caloric restriction or caloric restriction alone for 26 weeks. Anthropometrics, blood pressure, fasting glucose and insulin, HOMA-IR, glycated hemoglobin, lipids, uric acid, creatinphosphokynase, C-reactive protein were assessed. Body composition was evaluated with direct-segmental, multi-frequency Bioelectrical Impedance Analysis. Both groups lost approximately 10% of weight, with similar effects on waist circumference and fat mass. Change in free-fat mass was significantly different between groups (caloric restriction -1.5±0.2 vs. Whole-Body Electromyostimulation plus caloric restriction +1.1±0.4 kg, p=0.03). Whole-Body Electromyostimulation plus caloric restriction group experienced greater percent reductions in insulin (-45.5±4.4 vs. -28.2±3.6%, p=0.002), HOMA-IR (-51.3±3.2 vs. -25.1±1.8%, p=0.001), triglycerides (-22.5±2.9 vs. -4.1±1.6%, p=0.004) and triglycerides/HDL (p=0.028). Subjects trained with Whole-Body Electromyostimulation had also significant improvement in systolic pressure (138±4 vs. 126±7 mmHg, p=0.038). No discontinuations for adverse events occurred. In middle-aged sedentary subjects with the metabolic syndrome, Whole-Body Electromyostimulation with caloric restriction for 26 weeks can improve insulin-resistance and lipid profile compared to diet alone. Further studies are needed to ascertain long-term efficacy and feasibility of this approach in individuals with the metabolic syndrome.",2020,"Change in free-fat mass was significantly different between groups (caloric restriction -1.5±0.2 vs. Whole-Body Electromyostimulation plus caloric restriction +1.1±0.4 kg, p=0.03).","['middle-aged sedentary subjects with the metabolic syndrome', 'Metabolic Syndrome', 'individuals with the metabolic syndrome', 'sedentary middle-aged individuals']","['Whole-Body Electromyostimulation plus caloric restriction or caloric restriction alone', 'Whole-Body Electromyostimulation added to hypocaloric diet']","['triglycerides', 'insulin-resistance and lipid profile', 'systolic pressure', 'metabolic syndrome features', 'waist circumference and fat mass', 'Body composition', 'HOMA-IR', 'free-fat mass', 'triglycerides/HDL', 'adverse events', 'Anthropometrics, blood pressure, fasting glucose and insulin, HOMA-IR, glycated hemoglobin, lipids, uric acid, creatinphosphokynase, C-reactive protein']","[{'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1135809', 'cui_str': 'Decreased energy diet'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}]",25.0,0.0367421,"Change in free-fat mass was significantly different between groups (caloric restriction -1.5±0.2 vs. Whole-Body Electromyostimulation plus caloric restriction +1.1±0.4 kg, p=0.03).","[{'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Bellia', 'Affiliation': 'Department of Systems Medicine, University of Rome Tor Vergata, Roma, Italy.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Ruscello', 'Affiliation': 'School of Sports and Exercise Sciences, Telematic University San Raffaele Rome Srl, Roma, Italy.'}, {'ForeName': 'Rolando', 'Initials': 'R', 'LastName': 'Bolognino', 'Affiliation': 'Sapienza University of Rome, Unitelma Sapienza, Roma, Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Briotti', 'Affiliation': 'School of Sports and Exercise Sciences, Telematic University San Raffaele Rome Srl, Roma, Italy.'}, {'ForeName': 'Paolo Roberto', 'Initials': 'PR', 'LastName': 'Gabrielli', 'Affiliation': 'School of Sports and Exercise Sciences , University of Rome Tor Vergata, Roma, Italy.'}, {'ForeName': 'Adriano', 'Initials': 'A', 'LastName': 'Silvestri', 'Affiliation': 'Urban Fitness EMS Institute, Urban Fitness, Milano, Italy.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Rosazza', 'Affiliation': 'Fondazione IRCCS Istituto Neurologico ""Carlo Besta"", Neuroradiology Dept., Milano, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Ambruoso', 'Affiliation': 'Faculty of Medicine and Surgery, School of Sports and Exercise Sciences, University of Rome Tor Vergata, Roma, Italy.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Lombardo', 'Affiliation': 'Department of Human Sciences and Promotion of the Quality of Life, Telematic University San Raffaele Rome Srl, Roma, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Bernardini', 'Affiliation': 'Faculty of Medicine and Surgery, School of Sports and Exercise Sciences, University of Rome Tor Vergata, Roma, Italy.'}, {'ForeName': 'Cosimo', 'Initials': 'C', 'LastName': 'Calabrese', 'Affiliation': 'Department of Clinical Sciences and Translational Medicine, University of Rome Tor Vergata, Roma, Italy.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Lauro', 'Affiliation': 'Department of Systems Medicine, University of Rome Tor Vergata, Roma, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': ""D'Ottavio"", 'Affiliation': 'School of Sports and Exercise Sciences, Telematic University San Raffaele Rome Srl, Roma, Italy.'}]",International journal of sports medicine,['10.1055/a-1171-2003']
1196,32588047,A Combined Nutrition and Exercise Intervention Influences Serum Vitamin B-12 and 25-Hydroxyvitamin D and Bone Turnover of Healthy Chinese Middle-Aged and Older Adults.,"BACKGROUND


Hong Kong faces several public health problems including malnutrition and osteoporosis. Considering the typical Chinese diet and overall low physical activity levels of Chinese adults, timely interventions to improve nutritional status and bone health are needed.
OBJECTIVES


We examined the effects of a nutrition plus exercise intervention on serum vitamin B-12 and 25-hydroxyvitamin D [25(OH)D], bone turnover markers, and parathyroid hormone (PTH) concentrations in apparently healthy Chinese middle-aged and older adults.
METHODS


In this 24-wk randomized controlled trial, 180 Chinese adults (85 women, mean ± SD age: 61 ± 6 y) were randomly assigned to receive a fortified milk supplement (2 × 30 g/d) and an exercise program (2 × 1 h/wk including resistance, balance, and aerobic training) or no intervention. The primary outcome was physical performance. In this article we analyzed the secondary outcomes serum vitamin B-12 and 25(OH)D concentrations, assessed at baseline, 12 wk, and 24 wk. Also, bone turnover markers and PTH concentrations were studied. Linear mixed models evaluated group differences over time.
RESULTS


A significant time × group interaction (P < 0.001) was found for serum vitamin B-12 and 25(OH)D concentrations and the bone turnover markers, but not for serum PTH concentrations (P = 0.09). The intervention increased mean ± SD vitamin B-12 concentrations from baseline (345 ± 119 pmol/L) to 24 wk (484 ± 136 pmol/L), whereas concentrations remained stable within the control. For 25(OH)D concentrations, the intervention group had a greater increase from baseline (54.7 ± 14.2 nmol/L) to 24 wk (80.1 ± 19.2 nmol/L) than the control (60.6 ± 15.2 compared with 65.6 ± 14.6 nmol/L). The ratio of the net effect of bone formation and resorption was greater in the intervention group, suggesting less bone remodeling, irrespective of sex.
CONCLUSIONS


A fortified milk supplement and exercise intervention successfully improved vitamin B-12 and 25(OH)D concentrations as well as the balance of bone turnover markers of Chinese middle-aged and older adults.This trial was registered at trialregister.nl as NTR6214.",2020,A fortified milk supplement and exercise intervention successfully improved vitamin B-12 and 25(OH)D concentrations as well as the balance of bone turnover markers of Chinese middle-aged and older adults.,"['Healthy Chinese Middle-Aged and Older Adults', 'SD age: 61\xa0±\xa06 y', 'Chinese middle-aged and older adults', '180 Chinese adults (85 women, mean\xa0±', 'Chinese adults', 'apparently healthy Chinese middle-aged and older adults']","['fortified milk supplement', 'exercise program (2\xa0×\xa01\xa0h/wk including resistance, balance, and aerobic training) or no intervention', 'nutrition plus exercise intervention', 'Combined Nutrition and Exercise Intervention', 'fortified milk supplement and exercise intervention']","['serum vitamin B-12 and 25-hydroxyvitamin D [25(OH)D], bone turnover markers, and parathyroid hormone (PTH) concentrations', 'vitamin B-12 and 25(OH)D concentrations', 'serum vitamin B-12 and 25(OH)D concentrations and the bone turnover markers', 'bone formation and resorption', 'physical performance', 'Serum Vitamin B-12 and 25-Hydroxyvitamin D and Bone Turnover', 'serum PTH concentrations', 'serum vitamin B-12 and 25(OH)D concentrations', 'mean\xa0±\xa0SD vitamin B-12 concentrations', 'bone turnover markers and PTH concentrations']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]","[{'cui': 'C1532525', 'cui_str': 'Fortified milk'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0428581', 'cui_str': 'Serum vitamin A measurement'}, {'cui': 'C0042845', 'cui_str': 'Vitamin B 12'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0020063', 'cui_str': 'PTH protein, human'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0029433', 'cui_str': 'Bone formation'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0428408', 'cui_str': 'Serum parathyroid hormone measurement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",180.0,0.0580461,A fortified milk supplement and exercise intervention successfully improved vitamin B-12 and 25(OH)D concentrations as well as the balance of bone turnover markers of Chinese middle-aged and older adults.,"[{'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Groenendijk', 'Affiliation': 'Division of Human Nutrition and Health, Wageningen University & Research, Wageningen, Netherlands.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Chan', 'Affiliation': 'Department of Medicine & Therapeutics, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Woo', 'Affiliation': 'Department of Medicine & Therapeutics, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'Sherlin', 'Initials': 'S', 'LastName': 'Ong', 'Affiliation': 'FrieslandCampina, Amersfoort, Netherlands.'}, {'ForeName': 'Panam', 'Initials': 'P', 'LastName': 'Parikh', 'Affiliation': 'FrieslandCampina, Amersfoort, Netherlands.'}, {'ForeName': 'Marjolijn C E', 'Initials': 'MCE', 'LastName': 'Bragt', 'Affiliation': 'FrieslandCampina, Amersfoort, Netherlands.'}, {'ForeName': 'Lisette C P G M', 'Initials': 'LCPGM', 'LastName': 'de Groot', 'Affiliation': 'Division of Human Nutrition and Health, Wageningen University & Research, Wageningen, Netherlands.'}]",The Journal of nutrition,['10.1093/jn/nxaa149']
1197,32592986,"A Phase III, randomized, double-blind, placebo-controlled, multicenter study of fruquintinib in Chinese patients with advanced nonsquamous non-small-cell lung cancer - The FALUCA study.","OBJECTIVES


Fruquintinib is an orally active kinase inhibitor that selectively targets the vascular endothelial growth factor (VEGF) receptor. A Phase II trial has demonstrated a significant benefit in progression-free survival (PFS) for fruquintinib-treated patients with locally advanced/metastatic nonsquamous non-small-cell lung cancer (NSCLC) who have progressed after second-line chemotherapy. This Phase III trial is a randomized, double-blind, multicenter trial to confirm fruquintinib's efficacy in the same patient population.
MATERIALS AND METHODS


From December 2015 to February 2018, 730 patients were screened, of whom 527 were enrolled into the study. Participants were randomized 2:1 to receive fruquintinib (n = 354) or placebo (n = 173) once daily for 3 weeks on-treatment, and 1 week off-treatment. Patients were stratified according to epidermal growth factor receptor mutation status and prior use of VEGF inhibitors. Primary endpoint was overall survival (OS).
RESULTS


Median OS was 8.9 months for the fruquintinib group and 10.4 months for placebo group (hazard ratio [HR] 1.02; 95 % confidence interval [CI], 0.82-1.28; P = 0.841), with median PFS of 3.7 months and 1.0 months, respectively (HR 0.34; 95 % CI, 0.28-0.43; P < 0.001). Objective response rate and disease control rate were 13.8 % and 66.7 % for fruquintinib, and 0.6 % and 24.9 % for placebo, respectively (P < 0.001). Hypertension was the most frequent treatment-emergent adverse event (≥grade 3) observed in fruquintinib-treated patients (21.0 %). Post hoc analysis revealed that fruquintinib prolonged the median OS for patients who did not receive subsequent antitumor therapy: 7.0 months versus 5.1 months for placebo (HR 0.65; 95 % CI, 0.46-0.91; P = 0.012). Patients receiving fruquintinib also reported improvements in quality of life for most functional scales measured by EORTC QLQ-C30 and LC13 questionnaires.
CONCLUSION


Although the study did not meet its primary endpoint, fruquintinib could be effective in combination with other agents for the treatment of patients with NSCLC who have failed second-line chemotherapy.",2020,"Patients receiving fruquintinib also reported improvements in quality of life for most functional scales measured by EORTC QLQ-C30 and LC13 questionnaires.
","['patients with NSCLC who have failed second-line chemotherapy', 'Chinese patients with advanced nonsquamous non-small-cell lung cancer ', 'From December 2015 to February 2018, 730 patients were screened, of whom 527 were enrolled into the study', 'same patient population', 'fruquintinib-treated patients with locally advanced/metastatic nonsquamous non-small-cell lung cancer (NSCLC) who have progressed after second-line chemotherapy']",['placebo'],"['Objective response rate and disease control rate', 'Median OS', 'Hypertension', 'fruquintinib prolonged the median OS', 'quality of life for most functional scales measured by EORTC QLQ-C30 and LC13 questionnaires', 'progression-free survival (PFS', 'overall survival (OS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4517805', 'cui_str': '527'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",730.0,0.694568,"Patients receiving fruquintinib also reported improvements in quality of life for most functional scales measured by EORTC QLQ-C30 and LC13 questionnaires.
","[{'ForeName': 'Shun', 'Initials': 'S', 'LastName': 'Lu', 'Affiliation': 'Shanghai Lung Cancer Center, Shanghai Chest Hospital, Jiao Tong University, China. Electronic address: shunlu@sjtu.edu.cn.'}, {'ForeName': 'Gongyan', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': 'Harbin Medical University Cancer Hospital, China.'}, {'ForeName': 'Yuping', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Jinan Central Hospital, China.'}, {'ForeName': 'Sanyuan', 'Initials': 'S', 'LastName': 'Sun', 'Affiliation': 'XuZhou Central Hospital, China.'}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Chang', 'Affiliation': 'Fudan University Shanghai Cancer Center, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Yao', 'Affiliation': ""The First Affiliated Hospital of Xi'an Jiaotong University, China.""}, {'ForeName': 'Zhendong', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'The Second Hospital of Anhui Medical University, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Ye', 'Affiliation': 'Xiamen Key Laboratory of Antitumor Drug Transformation Research, The First Affiliated Hospital of Xiamen University, China.'}, {'ForeName': 'Junguo', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': 'Nantong Tumor Hospital, China.'}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Shi', 'Affiliation': 'Linyi Cancer Hospital, China.'}, {'ForeName': 'Jianxing', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'The First Affiliated Hospital of Guangzhou Medical University, China.'}, {'ForeName': 'Xiaoqing', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': ""The Fifth Medical Center, General Hospital of the People's Liberation Army, China.""}, {'ForeName': 'Yiping', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Zhejiang Cancer Hospital, China.'}, {'ForeName': 'Zhihua', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Jiangxi Cancer Hospital, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Fang', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'Jilin Cancer Hospital, China.'}, {'ForeName': 'Chunhong', 'Initials': 'C', 'LastName': 'Hu', 'Affiliation': 'The Second Xiangya Hospital of Central South University, China.'}, {'ForeName': 'Weidong', 'Initials': 'W', 'LastName': 'Mao', 'Affiliation': ""Jiangyin People's Hospital, China.""}, {'ForeName': 'Yanping', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Hubei Cancer Hospital, China.'}, {'ForeName': 'Youling', 'Initials': 'Y', 'LastName': 'Gong', 'Affiliation': 'West China Hospital of Sichuan University, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Shan', 'Affiliation': 'Xinjiang Cancer Hospital, China.'}, {'ForeName': 'Zhixiong', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'Affiliated Hospital of Guangdong Medical University, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Jinling Hospital, Nanjing University School of Medicine, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'The First Hospital of Jilin University, China.'}, {'ForeName': 'Chong', 'Initials': 'C', 'LastName': 'Bai', 'Affiliation': 'Shanghai Changhai Hospital, China.'}, {'ForeName': 'Buhai', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': ""Northern Jiangsu People's Hospital, China.""}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Ma', 'Affiliation': 'Liaoning Cancer Hospital, China.'}, {'ForeName': 'Zhendong', 'Initials': 'Z', 'LastName': 'Zheng', 'Affiliation': 'General Hospital of Northern Theater Command, China.'}, {'ForeName': 'Mingfang', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'General Hospital of Ningxia Medical University, China.'}, {'ForeName': 'Zhijun', 'Initials': 'Z', 'LastName': 'Jie', 'Affiliation': ""The Fifth People's Hospital of Shanghai, China.""}, {'ForeName': 'Lejie', 'Initials': 'L', 'LastName': 'Cao', 'Affiliation': 'The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, China.'}, {'ForeName': 'Wangjun', 'Initials': 'W', 'LastName': 'Liao', 'Affiliation': 'Nanfang Hospital of Southern Medical University, China.'}, {'ForeName': 'Hongming', 'Initials': 'H', 'LastName': 'Pan', 'Affiliation': 'Sir Run Run Shaw Hospital Affiliated with School of Medicine, Zhejiang University, China.'}, {'ForeName': 'Dongning', 'Initials': 'D', 'LastName': 'Huang', 'Affiliation': 'The Fourth Affiliated Hospital of Guangxi Medical University, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Tongji Hospital, Tongji Medical College of Hust, China.'}, {'ForeName': 'Jinji', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': ""Guandong Provincial People's Hospital, China.""}, {'ForeName': 'Shukui', 'Initials': 'S', 'LastName': 'Qin', 'Affiliation': ""People's Liberation Army Cancer Center of Nanjing Jinling Hospital, China.""}, {'ForeName': 'Shenglin', 'Initials': 'S', 'LastName': 'Ma', 'Affiliation': ""Hangzhou First People's Hospital, China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Liang', 'Affiliation': 'Peking University Third Hospital, China.'}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Beijing Chest Hospital, Capital Medical University, China.'}, {'ForeName': 'Jianying', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'The First Affiliated Hospital, Zhejiang University, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Tao', 'Affiliation': 'The First Affiliated Hospital of Soochow University, China.'}, {'ForeName': 'Yijiang', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Hainan General Hospital, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Qiu', 'Affiliation': 'The First Affiliated Hospital of Nanchang University, China.'}, {'ForeName': 'Yunchao', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Yunnan Cancer Hospital, China.'}, {'ForeName': 'Sha', 'Initials': 'S', 'LastName': 'Guan', 'Affiliation': 'Hutchison MediPharma, Shanghai, China.'}, {'ForeName': 'Mengye', 'Initials': 'M', 'LastName': 'Peng', 'Affiliation': 'Hutchison MediPharma, Shanghai, China.'}, {'ForeName': 'Weiguo', 'Initials': 'W', 'LastName': 'Su', 'Affiliation': 'Hutchison MediPharma, Shanghai, China.'}]","Lung cancer (Amsterdam, Netherlands)",['10.1016/j.lungcan.2020.06.016']
1198,32592995,Proactive Integrated Consultation-Liaison Psychiatry: A new service model for the psychiatric care of general hospital inpatients.,"OBJECTIVE


To describe a new service model for the psychiatric care of general hospital inpatients, called Proactive Integrated Consultation-Liaison Psychiatry ('Proactive Integrated Psychological Medicine' in the UK).
METHOD


The new service model was developed especially for general hospital inpatient populations with multimorbidity, such as older medical inpatients. Its design was informed by the published literature and the clinical experience of C-L psychiatrists. It was operationalized by a process of iterative piloting.
RESULTS


The rationale for the new model and the principles underpinning it are outlined. Details of how to implement it, including a service manual and associated workbook, are provided. The training of clinicians to deliver it is described. The effectiveness and cost-effectiveness of this new service model is being evaluated. Whilst we have found it feasible to deliver and well-accepted by ward teams, potential challenges to its wider implementation are discussed.
CONCLUSION


Proactive Integrated Consultation-Liaison Psychiatry (PICLP) is a fusion of proactive consultation and integrated care, operationalized in a field-tested service manual. Initial experience indicates that it is feasible to deliver. Its effectiveness and cost effectiveness for older patients on acute medical wards is currently being evaluated in a large multicentre randomized controlled trial (The HOME Study).",2020,"The new service model was developed especially for general hospital inpatient populations with multimorbidity, such as older medical inpatients.","['general hospital inpatient populations with multimorbidity, such as older medical inpatients', ""general hospital inpatients, called Proactive Integrated Consultation-Liaison Psychiatry ('Proactive Integrated Psychological Medicine' in the UK"", 'general hospital inpatients', 'older patients on acute medical wards']","['Proactive Integrated Consultation-Liaison Psychiatry (PICLP', 'Proactive Integrated Consultation-Liaison Psychiatry']",['effectiveness and cost-effectiveness'],"[{'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1535889', 'cui_str': 'Multimorbidity'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C1305702', 'cui_str': 'Ward'}]","[{'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.0145088,"The new service model was developed especially for general hospital inpatient populations with multimorbidity, such as older medical inpatients.","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Sharpe', 'Affiliation': 'Psychological Medicine Research, University of Oxford Department of Psychiatry, Warneford Hospital, Oxford, UK. Electronic address: michael.sharpe@psych.ox.ac.uk.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Toynbee', 'Affiliation': 'Psychological Medicine Research, University of Oxford Department of Psychiatry, Warneford Hospital, Oxford, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Walker', 'Affiliation': 'Psychological Medicine Research, University of Oxford Department of Psychiatry, Warneford Hospital, Oxford, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': 'Psychological Medicine Research, University of Oxford Department of Psychiatry, Warneford Hospital, Oxford, UK.'}]",General hospital psychiatry,['10.1016/j.genhosppsych.2020.06.005']
1199,32598997,The effect of low-volume high-intensity interval training on cardiovascular health outcomes in type 2 diabetes: A randomised controlled trial.,"BACKGROUND


Low-volume high-intensity interval training (HIIT) may be a time-efficient strategy that leads to similar or superior improvements in cardiorespiratory fitness (CRF) and cardiovascular disease (CVD) risk factors when compared with moderate-intensity continuous training (MICT). Our study investigated the effect of low-volume HIIT or MICT versus sham placebo-control (PLA) on central arterial stiffness, hemodynamic responses, and CVD risk factors in adults with obesity and type 2 diabetes (T2D).
METHODS


Eligible participants were previously inactive adults with obesity and T2D. Individuals were randomly allocated to: i) HIIT (1 × 4 min cycling at 90% peak oxygen consumption [V̇O 2peak ]); ii) MICT (45 min of cycling at 60% VO 2peak ); or PLA. Training groups exercised thrice weekly for 12 weeks. Central arterial stiffness, hemodynamics and CVD risk factors were assessed at baseline and post-intervention. Analysis of covariance (ANCOVA) was used to examine changes following HIIT, MICT and PLA.
RESULTS


Thirty-five participants (age: 55.1 ± 1.4 years, BMI: 36.1 ± 0.8 kg/m 2 ) completed the study. A significant intervention effect was found for changes in pulse wave velocity (PWV) (p = .03), which reduced with HIIT (-0.3 ± 0.9 m/s) and MICT (-0.1 ± 1.1 m/s) but increased with PLA (0.8 ± 1.6 m/s). There was a significant intervention effect for changes in V̇O 2peak  (p < .01), glycosylated hemoglobin (p = .03), systolic blood pressure (p < .01), and waist circumference (p = .03), which all improved following MICT or HIIT but not PLA; there was no difference between MICT and HIIT.
CONCLUSIONS


Twelve minutes of low-volume HIIT per week leads to improvements in central arterial stiffness and cardiovascular health in inactive individuals with obesity and T2D.",2020,"A significant intervention effect was found for changes in pulse wave velocity (PWV) (p = .05), which reduced with HIIT (-0.3 ± 0.9 m/s) and MICT (-0.1 ± 1.1 m/s) but increased with PLA (0.8 ± 1.6 m/s).","['Eligible participants were previously inactive adults with obesity and T2D. Individuals', 'adults with obesity and type 2 diabetes (T2D', 'inactive individuals with obesity and T2D', 'Thirty-five participants (age: 55.1\u202f±\u202f1.4\u202fyears, BMI: 36.1\u202f±\u202f0.8\u202fkg/m 2 ) completed the study', 'type 2 diabetes']","['low-volume HIIT or MICT versus sham placebo-control (PLA', 'HIIT (1\u202f×\u202f4 min cycling at 90% peak oxygen consumption [V̇O 2peak ]); ii) MICT (45\u202fmin of cycling at 60% VO 2peak ); or PLA', 'low-volume high-intensity interval training', 'Low-volume high-intensity interval training (HIIT']","['waist circumference', 'Central arterial stiffness, hemodynamics and CVD risk factors', 'cardiovascular health outcomes', 'central arterial stiffness, hemodynamic responses, and CVD risk factors', 'cardiorespiratory fitness (CRF) and cardiovascular disease (CVD) risk factors', 'V̇O 2peak', 'glycosylated hemoglobin', 'systolic blood pressure', 'central arterial stiffness and cardiovascular health', 'pulse wave velocity (PWV']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517503', 'cui_str': '1.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}]","[{'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}]",,0.0978978,"A significant intervention effect was found for changes in pulse wave velocity (PWV) (p = .05), which reduced with HIIT (-0.3 ± 0.9 m/s) and MICT (-0.1 ± 1.1 m/s) but increased with PLA (0.8 ± 1.6 m/s).","[{'ForeName': 'Kimberley L', 'Initials': 'KL', 'LastName': 'Way', 'Affiliation': 'Faculty of Medicine and Health, Discipline of Exercise and Sports Science, University of Sydney, Camperdown, NSW, Australia; The Boden Collaboration for Obesity, Nutrition, Exercise and Eating Disorders, University of Sydney, Camperdown, NSW, Australia; The Charles Perkins Centre, University of Sydney, Camperdown, NSW, Australia. Electronic address: kim.way@deakin.edu.au.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Sabag', 'Affiliation': 'Faculty of Medicine and Health, Discipline of Exercise and Sports Science, University of Sydney, Camperdown, NSW, Australia; The Boden Collaboration for Obesity, Nutrition, Exercise and Eating Disorders, University of Sydney, Camperdown, NSW, Australia; The Charles Perkins Centre, University of Sydney, Camperdown, NSW, Australia.'}, {'ForeName': 'Rachelle N', 'Initials': 'RN', 'LastName': 'Sultana', 'Affiliation': 'Faculty of Medicine and Health, Discipline of Exercise and Sports Science, University of Sydney, Camperdown, NSW, Australia; The Boden Collaboration for Obesity, Nutrition, Exercise and Eating Disorders, University of Sydney, Camperdown, NSW, Australia; The Charles Perkins Centre, University of Sydney, Camperdown, NSW, Australia.'}, {'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Baker', 'Affiliation': 'School of Exercise Science, Australian Catholic University, Strathfield, NSW, Australia.'}, {'ForeName': 'Shelley E', 'Initials': 'SE', 'LastName': 'Keating', 'Affiliation': 'Centre for Research on Exercise, Physical Activity and Health, School of Human Movement, and Nutrition Sciences, The University of Queensland, St Lucia, QLD, Australia.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Lanting', 'Affiliation': 'School of Health Sciences, University of Newcastle, Ourimbah, NSW, Australia.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Gerofi', 'Affiliation': 'The Boden Collaboration for Obesity, Nutrition, Exercise and Eating Disorders, University of Sydney, Camperdown, NSW, Australia; The Charles Perkins Centre, University of Sydney, Camperdown, NSW, Australia.'}, {'ForeName': 'Vivienne H', 'Initials': 'VH', 'LastName': 'Chuter', 'Affiliation': 'Centre for Research on Exercise, Physical Activity and Health, School of Human Movement, and Nutrition Sciences, The University of Queensland, St Lucia, QLD, Australia.'}, {'ForeName': 'Ian D', 'Initials': 'ID', 'LastName': 'Caterson', 'Affiliation': 'The Boden Collaboration for Obesity, Nutrition, Exercise and Eating Disorders, University of Sydney, Camperdown, NSW, Australia; The Charles Perkins Centre, University of Sydney, Camperdown, NSW, Australia.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Twigg', 'Affiliation': 'The Charles Perkins Centre, University of Sydney, Camperdown, NSW, Australia; Central Clinical School, School of Medicine, University of Sydney, Camperdown, NSW, Australia.'}, {'ForeName': 'Nathan A', 'Initials': 'NA', 'LastName': 'Johnson', 'Affiliation': 'Faculty of Medicine and Health, Discipline of Exercise and Sports Science, University of Sydney, Camperdown, NSW, Australia; The Boden Collaboration for Obesity, Nutrition, Exercise and Eating Disorders, University of Sydney, Camperdown, NSW, Australia; The Charles Perkins Centre, University of Sydney, Camperdown, NSW, Australia.'}]",International journal of cardiology,['10.1016/j.ijcard.2020.06.019']
1200,32599148,Measuring Goal-Concordant Care: Results and Reflections From Secondary Analysis of a Trial to Improve Serious Illness Communication.,"CONTEXT


Many consider goal-concordant care (GCC) to be the most important of advance care planning and palliative care. Researchers face significant challenges in attempting to measure this outcome. We conducted a randomized controlled trial to assess the effects of a system-level intervention to improve serious illness communication on GCC and other outcomes.
OBJECTIVES


To describe our measurement approach to GCC, present findings from a post-hoc analysis of trial data, and discuss lessons learned about measuring GCC.
METHODS


Using trial data collected to measure GCC, we analyzed ratings and rankings from a nonvalidated survey of patient priorities in the setting of advanced cancer, the Life Priorities Scale, and compared outcomes with correlative measures.
RESULTS


Participants commonly rated several predetermined and literature-derived priorities as important but did so in ways that were commonly incongruent with rankings. Ratings were frequently stable over time; rankings less so. Rankings are more likely to help assess the degree to which care is goal concordant but may be best augmented by corollary measures that signal achievement of a given priority.
CONCLUSION


Measuring GCC remains a fundamental challenge to palliative care researchers. Ratings attest to the fact that many things matter to patients; however, rankings can better determine what matters most. Insights gained from our experience may guide future research aiming to use this outcome to assess the effect of intervention to improve serious illness care.",2020,Ratings were frequently stable over time; rankings less so.,[],"['GCC', 'system-level intervention']",[],[],"[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0544069,Ratings were frequently stable over time; rankings less so.,"[{'ForeName': 'Justin J', 'Initials': 'JJ', 'LastName': 'Sanders', 'Affiliation': ""Harvard Medical School, Boston, MA, USA; Department of Psychosocial Oncology and Palliative Care, Dana-Farber Cancer Institute, Boston, MA, USA; Ariadne Labs, Brigham and Women's Hospital and Harvard T. H. Chan School of Public Health, Boston, MA, USA; Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA. Electronic address: jsanders@ariadnelabs.org.""}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Miller', 'Affiliation': ""Ariadne Labs, Brigham and Women's Hospital and Harvard T. H. Chan School of Public Health, Boston, MA, USA.""}, {'ForeName': 'Meghna', 'Initials': 'M', 'LastName': 'Desai', 'Affiliation': ""Ariadne Labs, Brigham and Women's Hospital and Harvard T. H. Chan School of Public Health, Boston, MA, USA.""}, {'ForeName': 'Olaf P', 'Initials': 'OP', 'LastName': 'Geerse', 'Affiliation': ""Ariadne Labs, Brigham and Women's Hospital and Harvard T. H. Chan School of Public Health, Boston, MA, USA; Department of Pulmonary Diseases, Academic Medical Center, Amsterdam, The Netherlands.""}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Paladino', 'Affiliation': ""Harvard Medical School, Boston, MA, USA; Ariadne Labs, Brigham and Women's Hospital and Harvard T. H. Chan School of Public Health, Boston, MA, USA; Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Kavanagh', 'Affiliation': ""Department of Psychosocial Oncology and Palliative Care, Dana-Farber Cancer Institute, Boston, MA, USA; Ariadne Labs, Brigham and Women's Hospital and Harvard T. H. Chan School of Public Health, Boston, MA, USA.""}, {'ForeName': 'Joshua R', 'Initials': 'JR', 'LastName': 'Lakin', 'Affiliation': ""Harvard Medical School, Boston, MA, USA; Department of Psychosocial Oncology and Palliative Care, Dana-Farber Cancer Institute, Boston, MA, USA; Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Bridget A', 'Initials': 'BA', 'LastName': 'Neville', 'Affiliation': ""Ariadne Labs, Brigham and Women's Hospital and Harvard T. H. Chan School of Public Health, Boston, MA, USA.""}, {'ForeName': 'Susan D', 'Initials': 'SD', 'LastName': 'Block', 'Affiliation': ""Harvard Medical School, Boston, MA, USA; Department of Psychosocial Oncology and Palliative Care, Dana-Farber Cancer Institute, Boston, MA, USA; Ariadne Labs, Brigham and Women's Hospital and Harvard T. H. Chan School of Public Health, Boston, MA, USA; Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA; Department of Psychiatry, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Erik K', 'Initials': 'EK', 'LastName': 'Fromme', 'Affiliation': ""Harvard Medical School, Boston, MA, USA; Department of Psychosocial Oncology and Palliative Care, Dana-Farber Cancer Institute, Boston, MA, USA; Ariadne Labs, Brigham and Women's Hospital and Harvard T. H. Chan School of Public Health, Boston, MA, USA; Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Rachelle', 'Initials': 'R', 'LastName': 'Bernacki', 'Affiliation': ""Harvard Medical School, Boston, MA, USA; Department of Psychosocial Oncology and Palliative Care, Dana-Farber Cancer Institute, Boston, MA, USA; Ariadne Labs, Brigham and Women's Hospital and Harvard T. H. Chan School of Public Health, Boston, MA, USA; Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2020.06.023']
1201,32483072,Outcomes of resident-performed laser-assisted vs traditional phacoemulsification.,"PURPOSE


To compare the effectiveness of femtosecond laser-assisted cataract surgery (FLACS) and conventional phacoemulsification cataract surgery (CPS) by resident surgeons.
SETTING


Parkland Memorial Health and Hospital System, Dallas, Texas, USA.
DESIGN


Prospective randomized study.
METHODS


All surgeries to be performed by postgraduate year 3 and year 4 residents from October 2015 through June 2017 were eligible for inclusion. Patients were required to complete postoperative day 1, week 1, month 1, and month 3 visits. Specular microscopy was performed preoperatively and postoperatively. Surgeries were filmed, and each step was timed and compared. Surgeon and patient surveys were filled out postoperatively.
RESULTS


Of the 135 eyes of 96 subjects enrolled in the study, 64 eyes received FLACS and 71 eyes received CPS. There was no significant difference in corrected distance visual acuity (CDVA), either preoperatively or at the postoperative day 1, week 1, month 1, or month 3 visits (P = .469, .539, .701, .777, and .777, respectively). Cumulated dissipated energy and irrigation fluid usage were not different between FLACS and CPS (P = .521 and .368, respectively), nor was there a difference in the reduction of endothelial cell counts postoperatively (P = .881). Wound creation (P = .014), cortical cleanup (P = .009), and IOL implantation (P = .031) were faster in the CPS group. Survey results indicated that the overall patient experience was similar for FLACS and CPS.
CONCLUSIONS


This first prospective randomized trial evaluating resident-performed FLACS shows that, in resident hands, FLACS provides similar results to CPS regarding visual acuity, endothelial cell loss, operative time, patient satisfaction, and surgical complication rate.",2020,"There was no significant difference in best corrected visual acuity (BCVA), either preoperatively or at the postop day 1, week 1, month 1, or month 3 visits (P= 0.469, 0.539, 0.701, 0.777, and 0.777 respectively).","['All surgeries to be performed by PGY-3 & 4 residents from October 2015 through June 2017 were eligible for inclusion', 'Of the 135 eyes of 96 subjects enrolled in the study, 64 eyes received']","['Resident-Performed Laser-Assisted vs Traditional Phacoemulsification', 'CPS', 'conventional phacoemulsification cataract surgery (CPS', 'FLACS', 'femtosecond laser-assisted cataract surgery (FLACS']","['IOL implantation', 'Cumulated dissipated energy and irrigation fluid usage', 'best corrected visual acuity (BCVA', 'visual acuity, endothelial cell loss, operative time, patient satisfaction, and surgical complication rate', 'endothelial cell counts', 'cortical cleanup', 'Wound creation']","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0282545', 'cui_str': 'Phacoemulsification'}, {'cui': 'C0149958', 'cui_str': 'Partial Seizures, Complex'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C1531960', 'cui_str': 'Femtosecond pulsed laser device'}]","[{'cui': 'C0281658', 'cui_str': 'Intraocular Lymphoma'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0593225', 'cui_str': 'Solution for irrigation'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0225336', 'cui_str': 'Endothelial cell'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0429518', 'cui_str': 'Endothelial cell density'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0441513', 'cui_str': 'Construction'}]",96.0,0.0403187,"There was no significant difference in best corrected visual acuity (BCVA), either preoperatively or at the postop day 1, week 1, month 1, or month 3 visits (P= 0.469, 0.539, 0.701, 0.777, and 0.777 respectively).","[{'ForeName': 'Brock', 'Initials': 'B', 'LastName': 'Hansen', 'Affiliation': 'From the Department of Ophthalmology, The University of Texas Southwestern Medical Center, Dallas, Texas, USA.'}, {'ForeName': 'Preston H', 'Initials': 'PH', 'LastName': 'Blomquist', 'Affiliation': ''}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Ririe', 'Affiliation': ''}, {'ForeName': 'Severin', 'Initials': 'S', 'LastName': 'Pouly', 'Affiliation': ''}, {'ForeName': 'Chan', 'Initials': 'C', 'LastName': 'Nguyen', 'Affiliation': ''}, {'ForeName': 'W Matthew', 'Initials': 'WM', 'LastName': 'Petroll', 'Affiliation': ''}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'McCulley', 'Affiliation': ''}]",Journal of cataract and refractive surgery,['10.1097/j.jcrs.0000000000000253']
1202,32484444,A Social Media-Based Support Group for Youth Living With HIV in Nigeria (SMART Connections): Randomized Controlled Trial.,"BACKGROUND


Youth living with HIV (YLHIV) enrolled in HIV treatment experience higher loss to follow-up, suboptimal treatment adherence, and greater HIV-related mortality compared with younger children or adults. Despite poorer health outcomes, few interventions target youth specifically. Expanding access to mobile phone technology, in low- and middle-income countries (LMICs) in particular, has increased interest in using this technology to improve health outcomes. mHealth interventions may present innovative opportunities to improve adherence and retention among YLHIV in LMICs.
OBJECTIVE


This study aimed to test the effectiveness of a structured support group intervention, Social Media to promote Adherence and Retention in Treatment (SMART) Connections, delivered through a social media platform, on HIV treatment retention among YLHIV aged 15 to 24 years and on secondary outcomes of antiretroviral therapy (ART) adherence, HIV knowledge, and social support.
METHODS


We conducted a parallel, unblinded randomized controlled trial. YLHIV enrolled in HIV treatment for less than 12 months were randomized in a 1:1 ratio to receive SMART Connections (intervention) or standard of care alone (control). We collected data at baseline and endline through structured interviews and medical record extraction. We also conducted in-depth interviews with subsets of intervention group participants. The primary outcome was retention in HIV treatment. We conducted a time-to-event analysis examining time retained in treatment from study enrollment to the date the participant was no longer classified as active-on-treatment.
RESULTS


A total of 349 YLHIV enrolled in the study and were randomly allocated to the intervention group (n=177) or control group (n=172). Our primary analysis included data from 324 participants at endline. The probability of being retained in treatment did not differ significantly between the 2 study arms during the study. Retention was high at endline, with 75.7% (112/163) of intervention group participants and 83.4% (126/161) of control group participants active on treatment. HIV-related knowledge was significantly better in the intervention group at endline, but no statistically significant differences were found for ART adherence or social support. Intervention group participants overwhelmingly reported that the intervention was useful, that they enjoyed taking part, and that they would recommend it to other YLHIV.
CONCLUSIONS


Our findings of improved HIV knowledge and high acceptability are encouraging, despite a lack of measurable effect on retention. Retention was greater than anticipated in both groups, likely a result of external efforts that began partway through the study. Qualitative data indicate that the SMART Connections intervention may have contributed to retention, adherence, and social support in ways that were not captured quantitatively. Web-based delivery of support group interventions can permit people to access information and other group members privately, when convenient, and without travel. Such digital health interventions may help fill critical gaps in services available for YLHIV.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03516318; https://clinicaltrials.gov/ct2/show/NCT03516318.",2020,"HIV-related knowledge was significantly better in the intervention group at endline, but no statistically significant differences were found for ART adherence or social support.","['YLHIV aged 15 to 24 years and on secondary outcomes of antiretroviral therapy (ART) adherence, HIV knowledge, and social support', 'Youth living with HIV (YLHIV', 'A total of 349 YLHIV enrolled in the study and were randomly allocated to the intervention group (n=177) or control group (n=172', 'YLHIV enrolled in HIV treatment for less than 12 months', 'Youth Living With HIV in Nigeria (SMART Connections', '324 participants at endline']","['structured support group intervention, Social Media', 'SMART Connections intervention', 'SMART Connections (intervention) or standard of care alone (control']","['Retention', 'probability of being retained', 'ART adherence or social support', 'retention in HIV treatment', 'HIV-related knowledge']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0028075', 'cui_str': 'Nigeria'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0449379', 'cui_str': 'Connection'}, {'cui': 'C4517713', 'cui_str': '324'}]","[{'cui': 'C0036606', 'cui_str': 'Support Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0449379', 'cui_str': 'Connection'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",349.0,0.189111,"HIV-related knowledge was significantly better in the intervention group at endline, but no statistically significant differences were found for ART adherence or social support.","[{'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Dulli', 'Affiliation': 'FHI 360, Durham, NC, United States.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Ridgeway', 'Affiliation': 'FHI 360, Durham, NC, United States.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Packer', 'Affiliation': 'FHI 360, Durham, NC, United States.'}, {'ForeName': 'Kate R', 'Initials': 'KR', 'LastName': 'Murray', 'Affiliation': 'FHI 360, Durham, NC, United States.'}, {'ForeName': 'Tolulope', 'Initials': 'T', 'LastName': 'Mumuni', 'Affiliation': 'Center for Population and Reproductive Health, College of Medicine, University of Ibadan, Ibadan, Nigeria.'}, {'ForeName': 'Kate F', 'Initials': 'KF', 'LastName': 'Plourde', 'Affiliation': 'FHI 360, Durham, NC, United States.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'FHI 360, Durham, NC, United States.'}, {'ForeName': 'Adesola', 'Initials': 'A', 'LastName': 'Olumide', 'Affiliation': 'Center for Population and Reproductive Health, College of Medicine, University of Ibadan, Ibadan, Nigeria.'}, {'ForeName': 'Oladosu', 'Initials': 'O', 'LastName': 'Ojengbede', 'Affiliation': 'Center for Population and Reproductive Health, College of Medicine, University of Ibadan, Ibadan, Nigeria.'}, {'ForeName': 'Donna R', 'Initials': 'DR', 'LastName': 'McCarraher', 'Affiliation': 'FHI 360, Durham, NC, United States.'}]",Journal of medical Internet research,['10.2196/18343']
1203,32488988,"Authors' reply re: Mesh inlay, mesh kit or native tissue repair for women having repeat anterior or posterior prolapse surgery: randomised controlled trial (PROSPECT).",,2020,,['women having repeat anterior or posterior prolapse surgery'],['mesh kit or native tissue repair'],[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0812225', 'cui_str': 'Device kit'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}]",[],,0.201418,,"[{'ForeName': 'Cathryn Ma', 'Initials': 'CM', 'LastName': 'Glazener', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Breeman', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Hagen', 'Affiliation': 'NMAHP Research Unit, Glasgow Caledonian University, Glasgow, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Elders', 'Affiliation': 'Nursing, Midwifery and Allied Health Professions Research Unit, Glasgow Caledonian University, Glasgow, UK.'}, {'ForeName': 'Lorna', 'Initials': 'L', 'LastName': 'Aucott', 'Affiliation': 'University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Cooper', 'Affiliation': 'Gynaecology, Aberdeen Royal Infirmary, Aberdeen, UK.'}, {'ForeName': 'Fiona M', 'Initials': 'FM', 'LastName': 'Reid', 'Affiliation': ""St Mary's Hospital, Manchester University Hospitals NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK.""}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16302']
1204,32587397,The effect of 17% EDTA and QMiX ultrasonic activation on smear layer removal and sealer penetration: ex vivo study.,"This study aimed to compare the effect of conventional irrigation (CI) and passive ultrasonic irrigation (PUI) with 17% EDTA and QMiX on the maximum depth and percentage of sealer penetration into the dentinal tubules by confocal laser scanning microscopy (CLSM) and to describe the cleaning of root canal walls by scanning electron microscopy (SEM). Eighty single-rooted human mandibular premolars were instrumented and randomly assigned to four groups (n = 20): EDTA + CI, QMiX + CI, EDTA + PUI, and QMiX + PUI. Ten samples from each group were examined by SEM (2,000×) and the remaining 40 roots were filled with a single gutta-percha cone and AH Plus sealer mixed with 0.1% rhodamine B for analysis by CLSM (10×). Images were assessed at distances of 2 mm (apical), 5 mm (middle), and 8 mm (coronal) from the apex with the Leica Application Suite V4.10 software. The EDTA + PUI and QMiX + PUI protocols presented higher rates of debris/smear layer removal in the apical and middle thirds. The PUI was superior to CI in the maximum depth of sealer penetration at the middle third. The QMiX + PUI group had a higher percentage of sealer penetration at the apical third. The PUI and QMiX protocol improved debris/smear layer removal and tubular dentin sealer penetration.",2020,The PUI and QMiX protocol improved debris/smear layer removal and tubular dentin sealer penetration.,"['Ten samples from each group were examined by SEM (2,000×) and the remaining 40 roots were filled with a', 'Eighty single-rooted human mandibular premolars']","['conventional irrigation (CI) and passive ultrasonic irrigation (PUI) with 17% EDTA and QMiX', '17% EDTA and QMiX ultrasonic activation', 'single gutta-percha cone and AH Plus sealer mixed with 0.1% rhodamine B for analysis by CLSM']","['sealer penetration', 'rates of debris/smear layer removal', 'debris/smear layer removal and tubular dentin sealer penetration']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0026019', 'cui_str': 'Electron microscopic study'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0013618', 'cui_str': 'Edetic Acid'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0440200', 'cui_str': 'Gutta percha cone'}, {'cui': 'C0673096', 'cui_str': 'AH Plus'}, {'cui': 'C0449942', 'cui_str': 'Sealer'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0073194', 'cui_str': 'Rhodamine B'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0242841', 'cui_str': 'Confocal Laser Scanning Microscopy'}]","[{'cui': 'C0449942', 'cui_str': 'Sealer'}, {'cui': 'C0205321', 'cui_str': 'Penetrating'}, {'cui': 'C0440266', 'cui_str': 'Debris'}, {'cui': 'C0085070', 'cui_str': 'Smear Layer'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0332208', 'cui_str': 'Tubular'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}]",80.0,0.0357585,The PUI and QMiX protocol improved debris/smear layer removal and tubular dentin sealer penetration.,"[{'ForeName': 'Felipe de Souza', 'Initials': 'FS', 'LastName': 'Matos', 'Affiliation': 'Postgraduate Program in Dentistry, School of Dentistry, Federal University of Uberlândia (UFU), Uberlândia, MG, Brazil. felipe_smatos@hotmail.com.'}, {'ForeName': 'Fabrício Rutz', 'Initials': 'FR', 'LastName': 'da Silva', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, State University of Ponta Grossa (UEPG), Ponta Grossa, PR, Brazil.'}, {'ForeName': 'Luiz Renato', 'Initials': 'LR', 'LastName': 'Paranhos', 'Affiliation': 'Department of Preventive and Social Dentistry, School of Dentistry, Federal University of Uberlândia (UFU), Uberlândia, MG, Brazil.'}, {'ForeName': 'Camilla Christian Gomes', 'Initials': 'CCG', 'LastName': 'Moura', 'Affiliation': 'Department of Endodontics, School of Dentistry, Federal University of Uberlândia (UFU), Uberlândia, MG, Brazil.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Bresciani', 'Affiliation': 'Department of Restorative Dentistry, Institute of Science and Technology, São Paulo State University (Unesp), São José dos Campos, SP, Brazil.'}, {'ForeName': 'Marcia Carneiro', 'Initials': 'MC', 'LastName': 'Valera', 'Affiliation': 'Department of Restorative Dentistry, Institute of Science and Technology, São Paulo State University (Unesp), São José dos Campos, SP, Brazil.'}]",Scientific reports,['10.1038/s41598-020-67303-z']
1205,32591238,D-cycloserine augmentation of cognitive behavioral therapy for delusions: A randomized clinical trial.,"OBJECTIVE


D-cycloserine (DCS) promotes consolidation of extinction learning. This study extends earlier work by examining whether DCS can enhance cognitive behavioral therapy (CBT) for delusions.
METHODS


Adults reporting moderate or greater delusions were randomly assigned to receive 50 mg of DCS or placebo prior to 10 weekly CBT sessions. The primary outcome was change in severity of delusions measured with the Psychotic Symptom Rating Scale delusion subscale (PSYRATS-D). Secondary outcomes included persistence of response at 3 and 6 month follow-up and the effects of DCS on memory consolidation and cognitive flexibility. Fifty-eight participants were randomized and 44 completed the trial.
RESULTS


The DCS and placebo groups did not differ in change from baseline to end of CBT on PSYRATS-D, nor did DCS improve memory consolidation or cognitive flexibility compared to placebo. However, at the 3 month follow-up visit (week 24), 47% of participants who completed treatment with DCS reported a 20% or greater decrease on PSYRATS-D compared to 15% in the placebo group (p = .04). Change in distress across CBT sessions interacted with treatment group to predict change from baseline to week 24 in PSYRATS-D total score (p = .03) such that response at week 24 was greatest in DCS-treated participants who experienced a decrease in distress during CBT sessions.
CONCLUSIONS


DCS augmentation of CBT did not improve delusions compared to placebo during treatment; however, DCS was associated with a higher response rate at 3-month follow-up. DCS may produce a delayed therapeutic effect, associated with successful CBT sessions, but this finding requires replication.",2020,"The DCS and placebo groups did not differ in change from baseline to end of CBT on PSYRATS-D, nor did DCS improve memory consolidation or cognitive flexibility compared to placebo.","['delusions', 'Adults reporting moderate or greater delusions', 'Fifty-eight participants were randomized and 44 completed the trial']","['D-cycloserine (DCS', 'DCS or placebo', 'cognitive behavioral therapy', 'DCS', 'placebo']","['distress', 'delusions', 'persistence of response at 3 and 6\xa0month follow-up and the effects of DCS on memory consolidation and cognitive flexibility', 'memory consolidation or cognitive flexibility', 'response rate', 'change in severity of delusions measured with the Psychotic Symptom Rating Scale delusion subscale (PSYRATS-D']","[{'cui': 'C0011253', 'cui_str': 'Delusions'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0010590', 'cui_str': 'Cycloserine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0011253', 'cui_str': 'Delusions'}, {'cui': 'C0546816', 'cui_str': 'Persistence'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0010590', 'cui_str': 'Cycloserine'}, {'cui': 'C0679057', 'cui_str': 'Memory Consolidation'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C3532768', 'cui_str': 'Psychotic symptom rating scales delusions subscale'}]",58.0,0.287105,"The DCS and placebo groups did not differ in change from baseline to end of CBT on PSYRATS-D, nor did DCS improve memory consolidation or cognitive flexibility compared to placebo.","[{'ForeName': 'Erica D', 'Initials': 'ED', 'LastName': 'Diminich', 'Affiliation': 'Program in Public Health and the Department of Family, Population and Preventive Medicine, Stony Brook University, Stony Brook, NY, United States of America.'}, {'ForeName': 'Faith', 'Initials': 'F', 'LastName': 'Dickerson', 'Affiliation': 'Sheppard Pratt Health System, Baltimore, MD, United States of America.'}, {'ForeName': 'Iruma', 'Initials': 'I', 'LastName': 'Bello', 'Affiliation': 'New York State Psychiatric Institute, Columbia University Vagelos College of Physicians and Surgeons, New York, NY, United States of America.'}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Cather', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, United States of America.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kingdon', 'Affiliation': 'Clinical and Experimental Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Pamela J', 'Initials': 'PJ', 'LastName': 'Rakhshan Rouhakhtar', 'Affiliation': 'Human Services Psychology Department, University of Maryland Baltimore County, Baltimore, MD, United States of America.'}, {'ForeName': 'Kamber L', 'Initials': 'KL', 'LastName': 'Hart', 'Affiliation': 'Department of Psychiatry, NYU Langone Health, New York, NY, United States of America.'}, {'ForeName': 'Chenxiang', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Department of Population Health, Division of Biostatistics, NYU School of Medicine, New York, NY, United States of America.'}, {'ForeName': 'Andrea B', 'Initials': 'AB', 'LastName': 'Troxel', 'Affiliation': 'Department of Population Health, Division of Biostatistics, NYU School of Medicine, New York, NY, United States of America.'}, {'ForeName': 'Donald C', 'Initials': 'DC', 'LastName': 'Goff', 'Affiliation': 'Department of Psychiatry, NYU Langone Health, New York, NY, United States of America; Nathan Kline Institute for Psychiatric Research, Orangeburg, NY, United States of America. Electronic address: Donald.Goff@nyulangone.org.'}]",Schizophrenia research,['10.1016/j.schres.2020.06.015']
1206,32592736,Challenges in Using Insurance Claims Data to Identify Palliative Care Patients for a Research Trial.,"BACKGROUND


Little is known about strategies for enrolling patients in home-based palliative care programs despite the need to conduct effectiveness studies of this emerging industry.
PURPOSE


We used medical claims data from Accountable Care Organizations in California to identify patients for a randomized controlled trial of home-based palliative care. We report outcomes from this strategy and the implications for future research.
RESULTS


Claims data identified 1357 patients. Research assistants could not reach 986 patients (72.7%), usually because the phone calls went unanswered (38.5%) and many patients' phone numbers were missing or incorrect (16.3%). Of 371 patients reached, 163 opted out. Of 208 patients screened, 177 were ineligible for the trial. Just 10 patients were enrolled.
RECOMMENDATIONS


Our findings suggest that medical claims data may not be useful for engaging patients potentially eligible for palliative care research trials. We recommend that alternative identification and recruitment strategies be considered.",2020,"Research assistants could not reach 986 patients (72.7%), usually because the phone calls went unanswered (38.5%) and many patients' phone numbers were missing or incorrect (16.3%).","['371 patients reached, 163 opted out', 'Just 10 patients were enrolled', '1,357 patients', '208 patients screened, 177 were ineligible for the trial', 'enrolling patients in home-based palliative care (HBPC) programs']",['HBPC'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}]",[],10.0,0.055076,"Research assistants could not reach 986 patients (72.7%), usually because the phone calls went unanswered (38.5%) and many patients' phone numbers were missing or incorrect (16.3%).","[{'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Enguidanos', 'Affiliation': 'Leonard Davis School of Gerontology, University of Southern California, Los Angeles, California, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Rahman', 'Affiliation': 'Leonard Davis School of Gerontology, University of Southern California, Los Angeles, California, USA. Electronic address: anrahman@protonmail.com.'}, {'ForeName': 'Torrie', 'Initials': 'T', 'LastName': 'Fields', 'Affiliation': 'Blue Shield of California, San Francisco, California, USA; VotiveHealth, San Luis Obispo, California, USA.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Mack', 'Affiliation': 'Keck School of Medicine, University of Southern California, Los Angeles, California, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Brumley', 'Affiliation': 'Reliance Hospice and Palliative Care, Costa Mesa, California, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Rabow', 'Affiliation': 'University of California, San Francisco, California, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Mert', 'Affiliation': 'Keck School of Medicine, University of Southern California, Los Angeles, California, USA.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2020.06.007']
1207,32594786,Intralesional betamethasone  versus  triamcinolone acetonide in the treatment of localized alopecia areata: a within-patient randomized controlled trial.,"BACKGROUND


Betamethasone can be used for intralesional infiltration, but there is little evidence in the literature to indicate its effectiveness in alopecia areata.
OBJECTIVE


To assess the safety and effectiveness of the use of different doses of intralesional betamethasone, when compared to triamcinolone acetonide for the treatment of alopecia areata.
METHODS


We recruited 12 patients with alopecia patch divided into four quadrants. Each quadrant, after randomization, received an intralesional injection with one of the following treatments: triamcinolone acetonide 2.5 mg/ml, betamethasone 0.375 mg/ml, betamethasone 1.75 mg/ml, or 0.9% saline (placebo). The intervention was repeated in the same quadrant every 4 weeks, totaling 3 sessions. Visual and dermoscopic evaluation of the results were performed. Trial registration: ReBec RBR-5kyg2r.
RESULTS


At 4 and 8 weeks of intervention, triamcinolone acetonide 2.5 mg/ml provided the best visual results. Nevertheless, at the end of the study, the best visual results were seen with both triamcinolone acetonide and betamethasone 1.75 mg/ml, with significant difference when compared to betamethasone 0.375 mg/ml and placebo ( p =.0489 and <.0001, respectively). There was a progressive reduction in the number of dystrophic hairs in all quadrants.
CONCLUSION


Triamcinolone acetonide shows earlier results in repilation, but at 12 weeks betamethasone 1.75 mg/ml had similar results.",2020,There was a progressive reduction in the number of dystrophic hairs in all quadrants.,"['localized alopecia areata', '12 patients with alopecia patch divided into four quadrants', 'alopecia areata']","['triamcinolone acetonide 2.5\u2009mg/ml, betamethasone 0.375mg/ml, betamethasone 1.75mg', 'betamethasone', 'Intralesional betamethasone  versus  triamcinolone acetonide', 'triamcinolone acetonide 2.5\u2009mg/ml', 'saline (placebo', 'intralesional betamethasone', 'Betamethasone', 'triamcinolone acetonide', 'Triamcinolone acetonide', 'placebo']","['safety and effectiveness', 'number of dystrophic hairs']","[{'cui': 'C0002170', 'cui_str': 'Alopecia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439738', 'cui_str': 'Four quadrants'}]","[{'cui': 'C0040866', 'cui_str': 'Triamcinolone acetonide'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0439294', 'cui_str': 'g/L'}, {'cui': 'C0005308', 'cui_str': 'Betamethasone'}, {'cui': 'C4517514', 'cui_str': '1.75'}, {'cui': 'C1512955', 'cui_str': 'Intralesional route'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0544849', 'cui_str': 'Hair dystrophy'}]",12.0,0.111164,There was a progressive reduction in the number of dystrophic hairs in all quadrants.,"[{'ForeName': 'Vando Barbosa', 'Initials': 'VB', 'LastName': 'de Sousa', 'Affiliation': 'Post-Graduation Program in Health Sciences, Universidade Federal do Ceará, Sobral, Brazil.'}, {'ForeName': 'Francisco Placido', 'Initials': 'FP', 'LastName': 'Arcanjo', 'Affiliation': 'Post-Graduation Program in Health Sciences, Universidade Federal do Ceará, Sobral, Brazil.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Aguiar', 'Affiliation': 'Department of Medicine, Universidade Federal do Piauí, Parnaíba, Brazil.'}, {'ForeName': 'Jaqueline', 'Initials': 'J', 'LastName': 'Vasconcelos', 'Affiliation': 'Departmant of Dermatology, Universidade do Estado do Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Antonio Flavio', 'Initials': 'AF', 'LastName': 'Oliveira', 'Affiliation': 'Post-Graduation Program in Health Sciences, Universidade Federal do Ceará, Sobral, Brazil.'}, {'ForeName': 'Aline', 'Initials': 'A', 'LastName': 'Honório', 'Affiliation': 'Department of Medicine, Centro Universitário INTA, Sobral, Brazil.'}, {'ForeName': 'Juliana', 'Initials': 'J', 'LastName': 'Pontes', 'Affiliation': 'Department of Medicine, Centro Universitário INTA, Sobral, Brazil.'}]",The Journal of dermatological treatment,['10.1080/09546634.2020.1788703']
1208,32602616,Safety and Efficacy of Budesonide for Liver Transplant Immune Suppression: Results of a Pilot Phase 2a Trial.,"Despite adverse effects like hyperglycemia, new-onset diabetes after transplant (NODAT), and infectious complications, corticosteroid use remains an important part of liver transplantation (LT) immune suppression. Budesonide, a synthetic corticosteroid, undergoes extensive first-pass hepatic metabolism with only 10% systemic bioavailability, providing an opportunity for an improved toxicity-therapeutic ratio. Although effective in the treatment of autoimmune hepatitis, the effects of budesonide for LT immune suppression are unknown. We conducted a single-center phase 2a trial to study the safety and efficacy of budesonide immunosuppressive therapy. From July 2017 to November 2018, 20 patients undergoing a first LT received budesonide tapering doses (from 9 to 3 mg) for 12 weeks. Patients were compared with matched control patients who received prednisone from the same time period. Additionally, both groups received calcineurin inhibitors and mycophenolate mofetil. Outcome measures at week 24 included rates of biopsy-proven acute cellular rejection (ACR), NODAT (hemoglobin A1c >6.4%), and infectious complications. In the budesonide arm, 1 patient developed ACR at week 5 and was removed from the study. Another patient stopped the study drug at week 8 due to persistent nausea. Rates of ACR were similar between the budesonide and control groups (5% versus 5%, P = 1.00). Three patients in the control group developed NODAT versus none in the budesonide group (15% versus 0%; P = 0.23). There were 6 infections in the control group compared with none in the budesonide group (30% versus 0; P = 0.02). These pilot data suggest that budesonide has the potential to be a safe and effective alternative to prednisone for LT immune suppression while reducing steroid-induced infections and NODAT. Randomized controlled trials are required to validate these findings.",2020,"Rates of ACR were similar between budesonide and control groups (5% vs 5%, p=1.00).","['Liver Transplant Immune Suppression', 'From July 2017 to November 2018, twenty subjects undergoing first LT received']","['prednisone', 'Budesonide', 'budesonide immunosuppressive therapy', 'budesonide', 'calcineurin inhibitors and mycophenolate']","['rates of biopsy proven Acute Cellular Rejection (ACR), NODAT (Glycated Hemoglobin > 6.4) and infectious complications', 'Safety and Efficacy', 'safety and efficacy', 'toxicity-therapeutic ratio', 'Rates of ACR']","[{'cui': 'C0023911', 'cui_str': 'Transplantation of liver'}, {'cui': 'C0021079', 'cui_str': 'Immunosuppressive therapy'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C0021079', 'cui_str': 'Immunosuppressive therapy'}, {'cui': 'C1453118', 'cui_str': 'CABIN1 protein, human'}, {'cui': 'C0883242', 'cui_str': 'MYCOPHENOLATE'}]","[{'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0877453', 'cui_str': 'Acute cellular rejection'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4517822', 'cui_str': '6.4'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0678793', 'cui_str': 'Therapeutic Index'}]",20.0,0.0575914,"Rates of ACR were similar between budesonide and control groups (5% vs 5%, p=1.00).","[{'ForeName': 'Khurram', 'Initials': 'K', 'LastName': 'Bari', 'Affiliation': 'Divisions of, Division of, Digestive Diseases, University of Cincinnati, Cincinnati, OH.'}, {'ForeName': 'Shimul A', 'Initials': 'SA', 'LastName': 'Shah', 'Affiliation': 'Division of, Endocrinology, Diabetes and Metabolism, Department of Medicine, University of Cincinnati, Cincinnati, OH.'}, {'ForeName': 'Tiffany E', 'Initials': 'TE', 'LastName': 'Kaiser', 'Affiliation': 'Divisions of, Division of, Digestive Diseases, University of Cincinnati, Cincinnati, OH.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Cohen', 'Affiliation': 'Transplant Surgery, Department of Surgery, University of Cincinnati, Cincinnati, OH.'}, {'ForeName': 'Nadeem', 'Initials': 'N', 'LastName': 'Anwar', 'Affiliation': 'Divisions of, Division of, Digestive Diseases, University of Cincinnati, Cincinnati, OH.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kleesattel', 'Affiliation': 'Department of Internal Medicine, University of Cincinnati, Cincinnati, OH.'}, {'ForeName': 'Kenneth E', 'Initials': 'KE', 'LastName': 'Sherman', 'Affiliation': 'Divisions of, Division of, Digestive Diseases, University of Cincinnati, Cincinnati, OH.'}]",Liver transplantation : official publication of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society,['10.1002/lt.25837']
1209,32609412,"Multifactorial Intervention on Type 2 Diabetes (MIDiab) Study: A multicenter, open-label, randomized, parallel controlled, community trial.",,2020,,[],['Multifactorial Intervention'],[],[],"[{'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0248914,,"[{'ForeName': 'Yupeng', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Endocrinology, Shandong Provincial Hospital, Cheeloo College of Medicine, Shandong University, Jinan, China.'}, {'ForeName': 'Qingbo', 'Initials': 'Q', 'LastName': 'Guan', 'Affiliation': 'Department of Endocrinology, Shandong Provincial Hospital, Cheeloo College of Medicine, Shandong University, Jinan, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Hou', 'Affiliation': 'Department of Endocrinology, Shandong Provincial Hospital, Cheeloo College of Medicine, Shandong University, Jinan, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Endocrinology, Shandong Provincial Hospital, Cheeloo College of Medicine, Shandong University, Jinan, China.'}, {'ForeName': 'Haiqing', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Endocrinology, Shandong Provincial Hospital, Cheeloo College of Medicine, Shandong University, Jinan, China.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Xu', 'Affiliation': 'Department of Endocrinology, Shandong Provincial Hospital, Cheeloo College of Medicine, Shandong University, Jinan, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Jing', 'Affiliation': 'Department of Endocrinology, Shandong Provincial Hospital, Cheeloo College of Medicine, Shandong University, Jinan, China.'}, {'ForeName': 'Shizhan', 'Initials': 'S', 'LastName': 'Ma', 'Affiliation': 'Department of Endocrinology, Shandong Provincial Hospital, Cheeloo College of Medicine, Shandong University, Jinan, China.'}, {'ForeName': 'Shanshan', 'Initials': 'S', 'LastName': 'Shao', 'Affiliation': 'Department of Endocrinology, Shandong Provincial Hospital, Cheeloo College of Medicine, Shandong University, Jinan, China.'}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Zhao', 'Affiliation': 'Department of Endocrinology, Shandong Provincial Hospital, Cheeloo College of Medicine, Shandong University, Jinan, China.'}, {'ForeName': 'Qingling', 'Initials': 'Q', 'LastName': 'Guo', 'Affiliation': 'Department of Endocrinology, Shandong Provincial Hospital, Cheeloo College of Medicine, Shandong University, Jinan, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Zhong', 'Affiliation': 'Department of Endocrinology, Shandong Provincial Hospital, Cheeloo College of Medicine, Shandong University, Jinan, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Gao', 'Affiliation': 'Shandong Provincial Key Laboratory of Endocrinology and Lipid Metabolism, Institute of Endocrinology and Metabolism, Shandong Academy of Clinical Medicine, Jinan, China.'}, {'ForeName': 'Jiajun', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Department of Endocrinology, Shandong Provincial Hospital, Cheeloo College of Medicine, Shandong University, Jinan, China.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of diabetes,['10.1111/1753-0407.13081']
1210,32488233,"An Afternoon Hummus Snack Affects Diet Quality, Appetite, and Glycemic Control in Healthy Adults.","BACKGROUND


Snacking continues to be a major component in the dietary patterns of most Americans despite conflicting evidence surrounding snacking healthfulness. Low-sugar, highly nutritive snacks, such as hummus, can lead to improvements in diet quality, appetite, and glycemic control.
OBJECTIVES


The purpose of the study was to examine the effects of afternoon snacking on diet quality, appetite, and glycemic control in healthy adults.
METHODS


Thirty-nine adults (age: 26 ± 1 y; BMI: 24.4 ± 0.5 kg/m2) randomly completed the following afternoon snack patterns for 6 d/pattern: hummus and pretzels [HUMMUS; 240 kcal; 6 g protein, 31 g carbohydrate (2 g sugar), 11 g fat]; granola bars [BARS; 240 kcal; 4 g protein, 38 g carbohydrate (16 g sugar), 9 g fat]; or no snacking (NO SNACK). On day 7 of each pattern, a standardized breakfast and lunch were provided. The respective snack was provided to participants 3 h after lunch, and appetite, satiety, and mood questionnaires were completed throughout the afternoon. At 3 h postsnack, a standardized dinner was consumed, and an evening snack cooler was provided to be consumed, ad libitum at home, throughout the evening. Lastly, 24 h continuous glucose monitoring was performed.
RESULTS


HUMMUS reduced subsequent snacking on desserts by ∼20% compared with NO SNACK (P = 0.001) and BARS (P < 0.001). HUMMUS led to greater dietary compensation compared with BARS (122 ± 31% compared with 72 ± 32%, respectively; P < 0.05). HUMMUS reduced indices of appetite (i.e., hunger, desire to eat, and prospective food consumption) by ∼70% compared with NO SNACK (all P < 0.05), whereas BARS did not. Additionally, satiety was ∼30% greater following HUMMUS and BARS compared with NO SNACK (both P < 0.005) with no differences between snacks. Lastly, HUMMUS reduced afternoon blood glucose concentrations by ∼5% compared with BARS (P < 0.05).
CONCLUSIONS


Acute consumption of a low-sugar, afternoon hummus snack improved diet quality and selected indices of appetite, satiety, and glycemic control in healthy adults. Long-term trials assessing the effects of hummus snacking on health outcomes are warranted.",2020,"HUMMUS led to greater dietary compensation compared with BARS (122 ± 31% compared with 72 ± 32%, respectively; P < 0.05).","['Healthy Adults', 'healthy adults', 'Thirty-nine adults (age: 26\xa0±']","['hummus snacking', 'afternoon snacking', 'afternoon snack patterns for 6 d/pattern: hummus and pretzels [HUMMUS; 240 kcal; 6\xa0g protein, 31\xa0g carbohydrate (2\xa0g sugar), 11\xa0g fat]; granola bars [BARS; 240 kcal; 4\xa0g protein, 38\xa0g carbohydrate (16\xa0g sugar), 9\xa0g fat]; or no snacking (NO SNACK']","['appetite (i.e., hunger, desire to eat, and prospective food consumption', 'BARS', 'satiety', 'dietary compensation', 'afternoon blood glucose concentrations', 'diet quality, appetite, and glycemic control', 'diet quality and selected indices of appetite, satiety, and glycemic control', 'appetite, satiety, and mood questionnaires', 'Diet Quality, Appetite, and Glycemic Control']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C3816447', 'cui_str': '39'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0453218', 'cui_str': 'Hummus'}, {'cui': 'C0439550', 'cui_str': 'Afternoon'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0458214', 'cui_str': 'Pretzels'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C1722869', 'cui_str': '(glycyl-prolyl-glycyl-glycyl-alanyl)6-glycine'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0001643', 'cui_str': 'Beta-2 adrenergic receptor'}, {'cui': 'C0086376', 'cui_str': 'G protein'}, {'cui': 'C0456636', 'cui_str': '16G'}]","[{'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0001643', 'cui_str': 'Beta-2 adrenergic receptor'}, {'cui': 'C0036239', 'cui_str': 'Satiety'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0152057', 'cui_str': 'Compensation'}, {'cui': 'C0439550', 'cui_str': 'Afternoon'}, {'cui': 'C2585282', 'cui_str': 'Blood glucose concentration'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",3.0,0.0284081,"HUMMUS led to greater dietary compensation compared with BARS (122 ± 31% compared with 72 ± 32%, respectively; P < 0.05).","[{'ForeName': 'Evan J', 'Initials': 'EJ', 'LastName': 'Reister', 'Affiliation': 'Department of Nutrition Science; Purdue University, West Lafayette, IN, USA.'}, {'ForeName': 'Heather J', 'Initials': 'HJ', 'LastName': 'Leidy', 'Affiliation': 'Department of Nutritional Sciences and Department of Pediatrics; University of Texas at Austin; Austin, TX, USA.'}]",The Journal of nutrition,['10.1093/jn/nxaa139']
1211,32485640,Improving B-mode ultrasound diagnostic performance for focal liver lesions using deep learning: A multicentre study.,"BACKGROUND


The diagnosis performance of B-mode ultrasound (US) for focal liver lesions (FLLs) is relatively limited. We aimed to develop a deep convolutional neural network of US (DCNN-US) for aiding radiologists in classification of malignant from benign FLLs.
MATERIALS AND METHODS


This study was conducted in 13 hospitals and finally 2143 patients with 24,343 US images were enrolled. Patients who had non-cystic FLLs with pathological results were enrolled. The FLLs from 11 hospitals were randomly divided into training and internal validations (IV) cohorts with a 4:1 ratio for developing and evaluating DCNN-US. Diagnostic performance of the model was verified using external validation (EV) cohort from another two hospitals. The diagnosis value of DCNN-US was compared with that of contrast enhanced computed tomography (CT)/magnetic resonance image (MRI) and 236 radiologists, respectively.
FINDINGS


The AUC of Model LBC  for FLLs was 0.924 (95% CI: 0.889-0.959) in the EV cohort. The diagnostic sensitivity and specificity of Model LBC  were superior to 15-year skilled radiologists (86.5% vs 76.1%, p = 0.0084 and 85.5% vs 76.9%, p = 0.0051, respectively). Accuracy of Model LBC  was comparable to that of contrast enhanced CT (both 84.7%) but inferior to contrast enhanced MRI (87.9%) for lesions detected by US.
INTERPRETATION


DCNN-US with high sensitivity and specificity in diagnosing FLLs shows its potential to assist less-experienced radiologists in improving their performance and lowering their dependence on sectional imaging in liver cancer diagnosis.",2020,"INTERPRETATION


DCNN-US with high sensitivity and specificity in diagnosing FLLs shows its potential to assist less-experienced radiologists in improving their performance and lowering their dependence on sectional imaging in liver cancer diagnosis.","['focal liver lesions using deep learning', '11 hospitals', '13 hospitals and finally 2143 patients with 24,343 US images were enrolled', 'Patients who had non-cystic FLLs with pathological results were enrolled']",['deep convolutional neural network of US (DCNN-US'],"['AUC of Model LBC  for FLLs', 'Diagnostic performance', 'diagnostic sensitivity and specificity of Model LBC  were superior to 15-year skilled radiologists']","[{'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0577053', 'cui_str': 'Lesion of liver'}, {'cui': 'C4704761', 'cui_str': 'Hierarchical Learning'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0205207', 'cui_str': 'Cystic'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]","[{'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0242406', 'cui_str': 'Neural Networks (Anatomic)'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}]","[{'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C1318045', 'cui_str': 'AKAP13 protein, human'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0577053', 'cui_str': 'Lesion of liver'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0036668', 'cui_str': 'Sensitivity and Specificity'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0260194', 'cui_str': 'Radiologist'}]",2143.0,0.0256485,"INTERPRETATION


DCNN-US with high sensitivity and specificity in diagnosing FLLs shows its potential to assist less-experienced radiologists in improving their performance and lowering their dependence on sectional imaging in liver cancer diagnosis.","[{'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Yang', 'Affiliation': 'Department of Interventional Ultrasound, Chinese PLA General Hospital, 28 Fuxing Road, Beijing 100853, China.'}, {'ForeName': 'Jingwei', 'Initials': 'J', 'LastName': 'Wei', 'Affiliation': 'Key Laboratory of Molecular Imaging, Institute of Automation, Chinese Academy of Sciences, Beijing, China; University of Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Xiaohan', 'Initials': 'X', 'LastName': 'Hao', 'Affiliation': 'Key Laboratory of Molecular Imaging, Institute of Automation, Chinese Academy of Sciences, Beijing, China; University of Chinese Academy of Sciences, Beijing, China; Centers for Biomedical Engineering, University of Science and Technology of China, University of Science and Technology of China, Hefei, China.'}, {'ForeName': 'Dexing', 'Initials': 'D', 'LastName': 'Kong', 'Affiliation': 'School of Mathematical Sciences, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Xiaoling', 'Initials': 'X', 'LastName': 'Yu', 'Affiliation': 'Department of Interventional Ultrasound, Chinese PLA General Hospital, 28 Fuxing Road, Beijing 100853, China.'}, {'ForeName': 'Tianan', 'Initials': 'T', 'LastName': 'Jiang', 'Affiliation': 'Department of Ultrasound, the First Affiliated hospital, College of Medicine, Zhejiang University, Hangzhou, Jiangsu, China.'}, {'ForeName': 'Junqing', 'Initials': 'J', 'LastName': 'Xi', 'Affiliation': 'Department of Interventional Ultrasound, Chinese PLA General Hospital, 28 Fuxing Road, Beijing 100853, China.'}, {'ForeName': 'Wenjia', 'Initials': 'W', 'LastName': 'Cai', 'Affiliation': 'Department of Interventional Ultrasound, Chinese PLA General Hospital, 28 Fuxing Road, Beijing 100853, China.'}, {'ForeName': 'Yanchun', 'Initials': 'Y', 'LastName': 'Luo', 'Affiliation': 'Department of Interventional Ultrasound, Chinese PLA General Hospital, 28 Fuxing Road, Beijing 100853, China.'}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Jing', 'Affiliation': 'Department of Ultrasound, Tianjin Third Central Hospital, Tianjin, China.'}, {'ForeName': 'Yilin', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': ""Department of Ultrasound Diagnosis, Tangdu Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Zhigang', 'Initials': 'Z', 'LastName': 'Cheng', 'Affiliation': 'Department of Interventional Ultrasound, Chinese PLA General Hospital, 28 Fuxing Road, Beijing 100853, China.'}, {'ForeName': 'Jinyu', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Ultrasound, Harbin The First Hospital, Harbin, China.'}, {'ForeName': 'Huiping', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': ""Department of Medical Ultrasound, Ma'anshan People's Hospital, Ma'anshan, China.""}, {'ForeName': 'Jintang', 'Initials': 'J', 'LastName': 'Liao', 'Affiliation': 'Department of Diagnostic Ultrasound, Xiangya Hospital, Changsha, China.'}, {'ForeName': 'Pei', 'Initials': 'P', 'LastName': 'Zhou', 'Affiliation': ""Department of Ultrasound, Central Theater Command General Hospital, Chinese People's Liberation Army, Wuhan, China.""}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Department of Diagnostic Ultrasound, The Second Affiliated Hospital of Dalian Medical University, Dalian, China.'}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Ultrasound, Beijing Ditan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Zhiyu', 'Initials': 'Z', 'LastName': 'Han', 'Affiliation': 'Department of Interventional Ultrasound, Chinese PLA General Hospital, 28 Fuxing Road, Beijing 100853, China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Cheng', 'Affiliation': 'Department of Ultrasound, Harbin Medical University Cancer Hospital, Harbin, China.'}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Tang', 'Affiliation': 'Department of Ultrasound, Fujian Cancer Hospital&Fujian Medical University Cancer Hospita, Fuzhou, China.'}, {'ForeName': 'Fangyi', 'Initials': 'F', 'LastName': 'Liu', 'Affiliation': 'Department of Interventional Ultrasound, Chinese PLA General Hospital, 28 Fuxing Road, Beijing 100853, China.'}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Dou', 'Affiliation': 'Department of Interventional Ultrasound, Chinese PLA General Hospital, 28 Fuxing Road, Beijing 100853, China.'}, {'ForeName': 'Rongqin', 'Initials': 'R', 'LastName': 'Zheng', 'Affiliation': 'Guangdong Key Laboratory of Liver Disease Research, Department of Medical Ultrasound, The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, China. Electronic address: zhengrq@mail.sysu.edu.cn.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'Department of Interventional Ultrasound, Chinese PLA General Hospital, 28 Fuxing Road, Beijing 100853, China. Electronic address: jiemi301@163.com.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Tian', 'Affiliation': 'Key Laboratory of Molecular Imaging, Institute of Automation, Chinese Academy of Sciences, Beijing, China; University of Chinese Academy of Sciences, Beijing, China; Beijing Advanced Innovation Center for Big Data-Based Precision Medicine, School of Medicine, Beihang University, Beijing, China. Electronic address: jie.tian@ia.ac.cn.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Liang', 'Affiliation': 'Department of Interventional Ultrasound, Chinese PLA General Hospital, 28 Fuxing Road, Beijing 100853, China. Electronic address: liangping301@hotmail.com.'}]",EBioMedicine,['10.1016/j.ebiom.2020.102777']
1212,32580480,Effectiveness of the Muscle Energy Technique versus Osteopathic Manipulation in the Treatment of Sacroiliac Joint Dysfunction in Athletes.,"BACKGROUND


The study of injuries stemming from sacroiliac dysfunction in athletes has been discussed in many papers. However, the treatment of this issue through thrust and muscle-energy techniques has hardly been researched. The objective of our research is to compare the effectiveness of thrust technique to that of energy muscle techniques in the resolution of sacroiliac joint blockage or dysfunction in middle-distance running athletes.
METHODS


A quasi-experimental design with three measures in time (pre-intervention, intervention 1, final intervention after one month from the first intervention) was made. The sample consisted of 60 adult athletes from an Athletic club, who were dealing with sacroiliac joint dysfunction. The sample was randomly divided into three groups of 20 participants (43 men and 17 women). One intervention group was treated with the thrust technique, another intervention group was treated with the muscle-energy technique, and the control group received treatment by means of a simulated technique. A prior assessment of the range of motion was performed by means of a seated forward flexion test, a standing forward flexion test, and the Gillet test. After observing the dysfunction, the corresponding technique was performed on each intervention group. The control group underwent a simulated technique. A second intervention took place a month later, in order to ascertain possible increased effectiveness.
RESULTS


Statistically significant differences were found between the muscle energy technique (MET) and muscle energy groups compared with the placebo group in both interventions ( p  = 0.000), with a significant reduction in positive dysfunction (initially 20 in all groups, eight in MET group, and two in thrust group in the final intervention). Comparing the changes in time, only the thrust group obtained statistically significant differences ( p  = 0.000, with a reduction of positive dysfunction, starting at 20 positives, five positive in the initial intervention and two positive in the final intervention) and when comparing both techniques, it was observed that between the first intervention and the final intervention, the thrust technique was significantly higher than the MET technique ( p  = 0.032).
CONCLUSIONS


The thrust manipulation technique is more effective in the treatment of sacroiliac dysfunction than the energy muscle technique, in both cases obtaining satisfactory results with far middle-distance running athletes. Finally, the thrust technique showed positive results in the first intervention and also in the long term, in contrast to the MET technique that only obtained changes after the first intervention.",2020,"Statistically significant differences were found between the muscle energy technique (MET) and muscle energy groups compared with the placebo group in both interventions ( p  = 0.000), with a significant reduction in positive dysfunction (initially 20 in all groups, eight in MET group, and two in thrust group in the final intervention).","['Sacroiliac Joint Dysfunction in Athletes', '60 adult athletes from an Athletic club, who were dealing with sacroiliac joint dysfunction', '20 participants (43 men and 17 women', 'middle-distance running athletes']","['simulated technique', 'Muscle Energy Technique versus Osteopathic Manipulation', 'placebo']",['positive dysfunction'],"[{'cui': 'C0036036', 'cui_str': 'Sacroiliac joint structure'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1510656', 'cui_str': 'Athletics'}, {'cui': 'C0149651', 'cui_str': 'Clubbing'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0035953', 'cui_str': 'Running'}]","[{'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C1562466', 'cui_str': 'Muscle energy technique'}, {'cui': 'C0949744', 'cui_str': 'Osteopathic manipulation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}]",60.0,0.0131154,"Statistically significant differences were found between the muscle energy technique (MET) and muscle energy groups compared with the placebo group in both interventions ( p  = 0.000), with a significant reduction in positive dysfunction (initially 20 in all groups, eight in MET group, and two in thrust group in the final intervention).","[{'ForeName': 'Urko José', 'Initials': 'UJ', 'LastName': 'García-Peñalver', 'Affiliation': 'Facultad de Fisioterapia, Universidad Católica de San Antonio (UCAM), Av. de los Jerónimos, 135, 30107 Murcia, Spain.'}, {'ForeName': 'María Victoria', 'Initials': 'MV', 'LastName': 'Palop-Montoro', 'Affiliation': 'Facultad de Fisioterapia, Universidad Católica de San Antonio (UCAM), Av. de los Jerónimos, 135, 30107 Murcia, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Manzano-Sánchez', 'Affiliation': 'Facultad de Ciencias del Deporte, Universidad de Murcia, Calle Argentina, 19, 30720 San Javier, Murcia Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17124490']
1213,32593228,Development and evaluation of e-learning materials for dental hygiene students in six schools: Using smartphones to learn dental treatment procedures.,"OBJECTIVE


The purpose of this study was to develop and evaluate the effectiveness of using e-learning on smartphones to provide dental hygiene education on dental treatment procedures.
METHODS


This was a randomized controlled trial. Two-hundred ninety-three dental hygiene students in four universities, one junior college and one technical school took a preliminary examination, and based on the results, participants in each school were randomly divided into two groups, a test or control group. Both groups took pre- and post-examinations at a 4-week interval. The test groups learned dental treatment procedures and four-handed techniques with interactive learning materials using smartphones. The learning materials allowed them to watch videos of dental treatments. The control groups were not provided any learning material.
RESULTS


Results of all schools combined showed that the changes from pre- to post-examination scores in the test groups were significantly higher than those of the control groups (p < .05). Post-examination scores were significantly higher than pre-examination scores in the test groups in all schools (p  < .05). Also, post-examination scores of the test groups were significantly higher than those of the control groups (p < .05). The changes from pre- to post-examination scores in the test groups of two schools were significantly higher than those of control groups (p < .05). Post-examination scores of the control groups in two schools were significantly higher than pre-examination scores (p < .05).
CONCLUSIONS


Learning dental treatment procedures through e-learning on a smartphone was effective in developing participants' understanding of dental treatment procedures and four-handed techniques.",2020,"CONCLUSIONS


Learning dental treatment procedures through e-learning on a smartphone was effective in developing participants' understanding of dental treatment procedures and four-handed techniques.","['Two-hundred ninety-three dental hygiene students in four universities, one junior college, and one technical school took a preliminary examination, and based on the results, participants in each school', 'dental hygiene students in six schools']","['e-learning', 'learned dental treatment procedures and four-handed techniques with interactive learning materials using smartphones']","['pre- to post-examination scores', 'Post-examination scores']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0029164', 'cui_str': 'Dental Hygiene'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0557812', 'cui_str': 'Community college'}, {'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0439611', 'cui_str': 'Preliminary'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0011331', 'cui_str': 'Dental care'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0815244', 'cui_str': 'Interactive Learning'}, {'cui': 'C0449902', 'cui_str': 'Material used'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",293.0,0.0139299,"CONCLUSIONS


Learning dental treatment procedures through e-learning on a smartphone was effective in developing participants' understanding of dental treatment procedures and four-handed techniques.","[{'ForeName': 'Akane', 'Initials': 'A', 'LastName': 'Takenouchi', 'Affiliation': 'Department of Educational Media Development, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Etsuyo', 'Initials': 'E', 'LastName': 'Otani', 'Affiliation': 'Shinjuku Medical Career College, Tokyo, Japan.'}, {'ForeName': 'Masayo', 'Initials': 'M', 'LastName': 'Sunaga', 'Affiliation': 'Department of Educational Media Development, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Takako', 'Initials': 'T', 'LastName': 'Toyama', 'Affiliation': 'Department of Oral Health Sciences, Faculty of Health Sciences, Osaka Dental University, Osaka, Japan.'}, {'ForeName': 'Hiromi', 'Initials': 'H', 'LastName': 'Uehara', 'Affiliation': 'Department of Oral Health, Kobe Tokiwa Junior College, Hyogo, Japan.'}, {'ForeName': 'Kyoko', 'Initials': 'K', 'LastName': 'Akiyama', 'Affiliation': 'Department of Health Sciences, School of Health and Social Services, Saitama Prefectural University, Saitama, Japan.'}, {'ForeName': 'Takae', 'Initials': 'T', 'LastName': 'Kawashima', 'Affiliation': 'Shinjuku Medical Career College, Tokyo, Japan.'}, {'ForeName': 'Kanade', 'Initials': 'K', 'LastName': 'Ito', 'Affiliation': 'Department of Oral Care for Systemic Health Support, Health Sciences and Biomedical Engineering, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Hiromi', 'Initials': 'H', 'LastName': 'Izuno', 'Affiliation': ""Department of Oral Health Sciences, Faculty of Nursing and Health Care, BAIKA Women's University, Osaka, Japan.""}, {'ForeName': 'Atsuhiro', 'Initials': 'A', 'LastName': 'Kinoshita', 'Affiliation': 'Department of Educational Media Development, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan.'}]",International journal of dental hygiene,['10.1111/idh.12452']
1214,32599641,Concurrent Exercise Interventions in Breast Cancer Survivors with Cancer-related Fatigue.,"This study compared the effects of two supervised concurrent training interventions in breast cancer survivors with cancer-related fatigue at baseline. Twenty-three female breast cancer survivors (50±8 years) were randomized to a high- (n=13) or a moderate-intensity (n=10) training program. Both interventions lasted 16 weeks and included the same resistance exercises, but the aerobic component was supervised and more intense in the former (i.e., rating of perceived exertion of 7-8 vs. 6 on a 1-10 scale for the high and moderate-intensity intervention, respectively). The primary endpoint was fatigue perception. Endpoints were assessed at baseline and after 16 weeks. The p-value for statistical significance was set at 0.004 after Bonferroni correction for multiple comparisons. The high-intensity training program increased lower-limb muscle strength significantly (p=0.002) and tended to improve fatigue perception (p=0.006), waist circumference (p=0.013), neutrophil-to-lymphocyte ratio (p=0.028) and some quality of life items (p=0.011). Although the moderate-intensity training program did not provide such benefits in general (i.e., higher p-values for pre vs post-intervention comparisons), no significant differences were found between interventions (all p>0.004). Further research is needed to elucidate if the benefits provided by high-intensity concurrent training are superior to those elicited by moderate-intensity training in breast cancer survivors.",2020,"The high-intensity training program increased lower-limb muscle strength significantly (p=0.002) and tended to improve fatigue perception (p=0.006), waist circumference (p=0.013), neutrophil-to-lymphocyte ratio (p=0.028) and some quality of life items (p=0.011).","['breast cancer survivors with cancer-related fatigue at baseline', 'breast cancer survivors', 'Breast Cancer Survivors with Cancer-related Fatigue', 'Twenty-three female breast cancer survivors (50±8 years']","['supervised concurrent training interventions', 'Concurrent Exercise Interventions', 'high- (n=13) or a moderate-intensity (n=10) training program']","['waist circumference', 'neutrophil-to-lymphocyte ratio', 'quality of life items', 'fatigue perception', 'lower-limb muscle strength']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C4274302', 'cui_str': 'Cancer-related fatigue'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C0235653', 'cui_str': 'Malignant neoplasm of female breast'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}]","[{'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}]",23.0,0.0278464,"The high-intensity training program increased lower-limb muscle strength significantly (p=0.002) and tended to improve fatigue perception (p=0.006), waist circumference (p=0.013), neutrophil-to-lymphocyte ratio (p=0.028) and some quality of life items (p=0.011).","[{'ForeName': 'Itiziar', 'Initials': 'I', 'LastName': 'Pagola', 'Affiliation': 'Faculty of Sport Sciences, Universidad Europea de Madrid, Spain.'}, {'ForeName': 'Javier S', 'Initials': 'JS', 'LastName': 'Morales', 'Affiliation': 'Faculty of Sport Sciences, Universidad Europea de Madrid, Spain.'}, {'ForeName': 'Lidia B', 'Initials': 'LB', 'LastName': 'Alejo', 'Affiliation': 'Faculty of Sport Sciences, Universidad Europea de Madrid, Spain.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Barcelo', 'Affiliation': 'Faculty of Sport Sciences, Universidad Europea de Madrid, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Montil', 'Affiliation': 'Faculty of Sport Sciences, Universidad Europea de Madrid, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Oliván', 'Affiliation': 'School of Physical Activity and Sport Sciences-INEF, Universidad Politecnica de Madrid, Madrid, Spain.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Álvarez-Bustos', 'Affiliation': 'Department of Medical Oncology, Puerta de Hierro University Hospital of Majadahonda, Majadahonda, Spain.'}, {'ForeName': 'Blanca', 'Initials': 'B', 'LastName': 'Cantos', 'Affiliation': 'Department of Medical Oncology, Puerta de Hierro University Hospital of Majadahonda, Majadahonda, Spain.'}, {'ForeName': 'Constanza', 'Initials': 'C', 'LastName': 'Maximiano', 'Affiliation': 'Department of Medical Oncology, Puerta de Hierro University Hospital of Majadahonda, Majadahonda, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Hidalgo', 'Affiliation': 'Faculty of Sport Sciences, Universidad Europea de Madrid, Spain.'}, {'ForeName': 'Pedro L', 'Initials': 'PL', 'LastName': 'Valenzuela', 'Affiliation': 'Physiology Unit, Systems Biology Department, University of Alcala de Henares, Madrid, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Fiuza-Luces', 'Affiliation': '12th of October Hospital Research Institute, Physiology, Madrid, Spain.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Lucia', 'Affiliation': 'Faculty of Sport Sciences, Universidad Europea de Madrid, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Ruiz-Casado', 'Affiliation': 'Department of Medical Oncology, Puerta de Hierro University Hospital of Majadahonda, Majadahonda, Spain.'}]",International journal of sports medicine,['10.1055/a-1147-1513']
1215,32604254,Effects of Hatha Yoga on Cardiac Hemodynamic Parameters and Physical Capacity in Cardiac Rehabilitation Patients.,"PURPOSE


The purpose of the present study was to assess the effect of hatha yoga training that was added to the standard cardiac rehabilitation (CR) program on the cardiac hemodynamic parameters and physical capacity of patients with ST-elevation myocardial infarction (STEMI).
METHODS


The study included 70 male patients aged 45-65 yr with STEMI who were treated by angioplasty. Patients were randomized to standard CR (control group) versus standard CR plus hatha yoga (experimental group). The training program lasted for a total of 24 d for each patient, with day 1 and day 24 used for medical examinations (electrocardiogram, spiroergometric submaximal treadmill test, and echocardiography). The remaining 22 d consisted of the actual training.
RESULTS


After the CR program the spiroergometric stress test parameters and left ventricular ejection fraction (LVEF) improved in both the experimental and control groups. The most notable changes in echocardiography parameters and physical capacity were in the experimental group. The results showed significant main effect over time, a time-versus-group interaction in LVEF, the duration of the test, and peak oxygen uptake, and a time-versus-group interaction in metabolic equivalents (METs). We also noted the improvement of left ventricular end-diastolic diameter, left ventricular end-systolic diameter, and heart rate over time.
CONCLUSION


The results revealed better effectiveness in the CR program with a modified hatha yoga training program. Hatha yoga training could be recommended as an adjunct to standard CR.",2020,After the CR program the spiroergometric stress test parameters and left ventricular ejection fraction (LVEF) improved in both the experimental and control groups.,"['70 male patients aged 45-65 yr with STEMI who were treated by', 'Cardiac Rehabilitation Patients', 'patients with ST-elevation myocardial infarction (STEMI']","['medical examinations (electrocardiogram, spiroergometric submaximal treadmill test, and echocardiography', 'Hatha Yoga', 'Hatha yoga training', 'angioplasty', 'standard cardiac rehabilitation (CR) program', 'standard CR (control group) versus standard CR plus hatha yoga', 'hatha yoga training']","['LVEF, the duration of the test, and peak oxygen uptake, and a time-versus-group interaction in metabolic equivalents (METs', 'cardiac hemodynamic parameters and physical capacity', 'spiroergometric stress test parameters and left ventricular ejection fraction (LVEF', 'left ventricular end-diastolic diameter, left ventricular end-systolic diameter, and heart rate over time', 'Cardiac Hemodynamic Parameters and Physical Capacity', 'echocardiography parameters and physical capacity']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1303258', 'cui_str': 'Acute ST segment elevation myocardial infarction'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}]","[{'cui': 'C0582103', 'cui_str': 'Medical assessment'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0087110', 'cui_str': 'Treadmill Test'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0162577', 'cui_str': 'Angioplasty of blood vessel'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C2355577', 'cui_str': 'Metabolic Equivalent'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}]",70.0,0.0168886,After the CR program the spiroergometric stress test parameters and left ventricular ejection fraction (LVEF) improved in both the experimental and control groups.,"[{'ForeName': 'Małgorzata', 'Initials': 'M', 'LastName': 'Grabara', 'Affiliation': 'Department of Physiotherapy in Internal Medicine, Jerzy Kukuczka Academy of Physical Education, Katowice, Poland.'}, {'ForeName': 'Zbigniew', 'Initials': 'Z', 'LastName': 'Nowak', 'Affiliation': ''}, {'ForeName': 'Agata', 'Initials': 'A', 'LastName': 'Nowak', 'Affiliation': ''}]",Journal of cardiopulmonary rehabilitation and prevention,['10.1097/HCR.0000000000000503']
1216,32604255,Interval Versus Continuous Aerobic Exercise Training in Overweight and Obese Patients With Chronic Obstructive Pulmonary Disease: A RANDOMIZED CONTROLLED STUDY.,"PURPOSE


The aim of this study was to compare the efficacy of the supervised pulmonary rehabilitation programs consisting of either an interval or continuous aerobic exercise program, with a home-based exercise program in patients with chronic obstructive pulmonary disease (COPD) who were overweight or obese.
METHODS


In this randomized controlled study, 72 overweight and obese patients diagnosed as having COPD were randomly assigned to 3 groups. Group 1 received an interval-type (IT) aerobic exercise program, group 2 received a continuous-type (CT) aerobic exercise program (both groups performed home exercises as well) and group 3 was only given a home-based exercise (HE) program. For the evaluation of patients, anthropometric measures, cardiopulmonary exercise testing (CPX), 6-min walk test (6MWT), modified-Borg dyspnea and leg fatigue scores, St George's Respiratory Questionnaire, and Hospital Anxiety and Depression Scale were used.
RESULTS


Both IT and CT groups showed significant improvement on CPX parameters, 6MWT distances, mental health, and health-related quality of life (HRQoL) compared with the HE group in overweight and obese patients with COPD (P < .001). Moreover, the IT group demonstrated a significant decrease in the modified-Borg dyspnea and leg fatigue during the CPX compared with both CT and HE groups (P < .001). Furthermore, the Borg dyspnea and leg fatigue during training were lower in the IT group than in the CT group (P < .05).
CONCLUSIONS


An interval or continuous aerobic exercise program added onto a home-based exercise program improved exercise capacity and HRQoL, and reduced anxiety and depression levels in overweight and obese patients with COPD.",2020,"Both IT and CT groups showed significant improvement on CPX parameters, 6MWT distances, mental health, and health-related quality of life (HRQoL) compared with the HE group in overweight and obese patients with COPD (P < .001).","['72 overweight and obese patients diagnosed as having COPD', 'overweight and obese patients with COPD', 'Overweight and Obese Patients With Chronic Obstructive Pulmonary Disease', 'patients with chronic obstructive pulmonary disease (COPD) who were overweight or obese']","['Interval Versus Continuous Aerobic Exercise Training', 'interval-type (IT) aerobic exercise program, group 2 received a continuous-type (CT) aerobic exercise program (both groups performed home exercises as well) and group 3 was only given a home-based exercise (HE) program', 'supervised pulmonary rehabilitation programs consisting of either an interval or continuous aerobic exercise program, with a home-based exercise program', 'continuous aerobic exercise program added onto a home-based exercise program']","[""anthropometric measures, cardiopulmonary exercise testing (CPX), 6-min walk test (6MWT), modified-Borg dyspnea and leg fatigue scores, St George's Respiratory Questionnaire, and Hospital Anxiety and Depression Scale"", 'Borg dyspnea and leg fatigue', 'CPX parameters, 6MWT distances, mental health, and health-related quality of life (HRQoL', 'exercise capacity and HRQoL, and reduced anxiety and depression levels', 'modified-Borg dyspnea and leg fatigue']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}]","[{'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}]","[{'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C2959886', 'cui_str': 'Cardiopulmonary exercise test'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0150135', 'cui_str': 'Alleviating anxiety'}, {'cui': 'C1319226', 'cui_str': 'Level of depression'}]",72.0,0.0502099,"Both IT and CT groups showed significant improvement on CPX parameters, 6MWT distances, mental health, and health-related quality of life (HRQoL) compared with the HE group in overweight and obese patients with COPD (P < .001).","[{'ForeName': 'Dilek Ozge Zincir', 'Initials': 'DOZ', 'LastName': 'Ercin', 'Affiliation': 'Departments of Physical Medicine and Rehabilitation (Drs Zincir Ercin, Alkan, Findikoglu, and Ardic) and Chest Diseases (Drs Dursunoglu and Evyapan), Faculty of Medicine, Pamukkale University Denizli, Turkey.'}, {'ForeName': 'Hakan', 'Initials': 'H', 'LastName': 'Alkan', 'Affiliation': ''}, {'ForeName': 'Gulin', 'Initials': 'G', 'LastName': 'Findikoglu', 'Affiliation': ''}, {'ForeName': 'Nese', 'Initials': 'N', 'LastName': 'Dursunoglu', 'Affiliation': ''}, {'ForeName': 'Fatma', 'Initials': 'F', 'LastName': 'Evyapan', 'Affiliation': ''}, {'ForeName': 'Fusun', 'Initials': 'F', 'LastName': 'Ardic', 'Affiliation': ''}]",Journal of cardiopulmonary rehabilitation and prevention,['10.1097/HCR.0000000000000519']
1217,32604256,Reduced Fine Particulate Matter Air Pollution Exposures Using In-Home Portable Air Cleaners: PILOT RESULTS OF THE CARDIAC REHABILITATION AIR FILTER TRIAL (CRAFT).,"PURPOSE


Fine particulate matter (PM2.5) air pollution is a leading risk factor for cardiovascular disease. Even low levels common to millions of Americans pose health risks. However, no study has tested protective measures such as in-home portable air cleaners (PACs) among at-risk cardiac patients. We conducted a pilot phase of the Cardiac Rehabilitation Air Filter Trial (CRAFT)-a randomized, double-blind, crossover study of outpatient cardiac rehabilitation patients at Michigan Medicine.
METHODS


During a routine visit, patients were provided with 2 PACs to run continuously for 5 d in both the bedroom and the main living space. PACs were randomized as active (with HEPA filter) versus sham. On day 4, subjects wore a personal PM2.5 monitor for 24-hr without activity restrictions. After a 1-wk washout, patients crossed over to the opposite mode.
RESULTS


Patients (n = 20; 4 women) were elderly (70.8 ± 9.6 yr) nonsmokers with cardiovascular disease living near the facility (10.7 ± 6.0 mi). Compared with sham, active in-home PAC use significantly lowered personal-level 24-hr PM2.5 exposures by 43.8% (-12.2 μg·m; 95% CI, -24.2 to -0.2). Sensitivity analyses corroborated the reductions in most patients.
CONCLUSION


An inexpensive in-home PAC can effectively lower personal PM2.5 exposures in cardiac patients. These benefits occurred even in a region with overall good air quality and if maintained over the long-term could translate into major reductions in cardiovascular events.",2020,"Compared with sham, active in-home PAC use significantly lowered personal-level 24-hr PM2.5 exposures by 43.8% (-12.2 μg·m; 95% CI, -24.2 to -0.2).","['Patients (n = 20; 4 women) were elderly (70.8 ± 9.6 yr) nonsmokers with cardiovascular disease living near the facility (10.7 ± 6.0 mi', 'Home Portable Air Cleaners', 'outpatient cardiac rehabilitation patients at Michigan Medicine', 'cardiac patients']",[],"['personal-level 24-hr PM2.5 exposures', 'Reduced Fine Particulate Matter Air Pollution Exposures', 'cardiovascular events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0337672', 'cui_str': 'Non-smoker'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C5191365', 'cui_str': '10.7'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0789995', 'cui_str': 'Air cleaner'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}, {'cui': 'C0025939', 'cui_str': 'Michigan'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}]",[],"[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0205232', 'cui_str': 'Fine'}, {'cui': 'C1720884', 'cui_str': 'Particulate Matter'}, {'cui': 'C0001873', 'cui_str': 'Air pollution'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",,0.140105,"Compared with sham, active in-home PAC use significantly lowered personal-level 24-hr PM2.5 exposures by 43.8% (-12.2 μg·m; 95% CI, -24.2 to -0.2).","[{'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Bard', 'Affiliation': 'Division of Cardiovascular Medicine, Michigan Medicine, Ann Arbor (Messrs Bard and Bryant, Drs Rubenfire and Brook, and Ms Fink); Department of Biostatistics, School of Public Health, University of Michigan, Ann Arbor (Dr Wang and Mss Speth and Zhou); and Department of Family Medicine, College of Human Medicine, Michigan State University, East Lansing (Dr Morishita).'}, {'ForeName': 'Melvyn', 'Initials': 'M', 'LastName': 'Rubenfire', 'Affiliation': ''}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Fink', 'Affiliation': ''}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Bryant', 'Affiliation': ''}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Speth', 'Affiliation': ''}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Zhou', 'Affiliation': ''}, {'ForeName': 'Masako', 'Initials': 'M', 'LastName': 'Morishita', 'Affiliation': ''}, {'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'Brook', 'Affiliation': ''}]",Journal of cardiopulmonary rehabilitation and prevention,['10.1097/HCR.0000000000000516']
1218,32611284,Alteplase for Acute Ischemic Stroke in Patients Aged >80 Years: Pooled Analyses of Individual Patient Data.,"BACKGROUND/PURPOSE


Expert guidelines specify no upper age limit for alteplase for thrombolysis of acute ischemic stroke (AIS) but, until recently, European regulatory criteria restricted its use to patients aged 18 to 80 years. We performed pooled analyses of randomized controlled trial (RCT) and registry data to evaluate the benefit-risk profile of alteplase for AIS among patients aged >80 years to support a regulatory application to lift the upper age restriction.
METHODS


Individual patient data were evaluated from 7 randomized trials of alteplase (0.9 mg/kg) versus placebo or open control for AIS, and the European SITS-UTMOST registry database. Clinical outcomes, including good functional outcome (score 0-1, modified Rankin Scale day 90 or Oxford Handicap Score day 180), were evaluated in the full RCT and registry populations, and specified age-based subgroups (≤80 or >80 years) who met existing European regulatory criteria for alteplase, excluding upper age restriction.
RESULTS


Regardless of treatment allocation, 90-day mortality was lower among RCT patients aged ≤80 versus >80 years who otherwise met existing European regulatory criteria (246/2405 [10.2%] versus 307/1028 [29.9%], respectively). Among patients aged >80 years, alteplase versus placebo was associated with a higher proportion of good stroke outcome (modified Rankin Scale score 0-1; 99/518 [19.1%] versus 67/510 [13.1%];  P =0.0109) and similar 90-day mortality (153/518 [29.5%] versus 154/510 [30.2%];  P =0.8382). The odds of a good stroke outcome following alteplase allocation in the full RCT population were independent of age ( P =0.7383). Good stroke outcome was reported for almost half (4821/11 169 [43.2%]) of the patients who received alteplase in routine practice. Outcomes in routine practice supported those achieved in RCTs.
CONCLUSIONS


Alteplase for AIS has a positive benefit-risk profile among patients aged >80 years when administered according to other regulatory criteria. Alteplase for AIS should be evaluated on an individual benefit-risk basis.",2020,"Among patients aged >80 years, alteplase versus placebo was associated with a higher proportion of good stroke outcome (modified Rankin Scale score 0-1; 99/518 [19.1%] versus 67/510 [13.1%];  P =0.0109) and similar 90-day mortality (153/518 [29.5%] versus 154/510 [30.2%];  P =0.8382).","['Individual patient data', 'patients aged >80 years', 'patients aged 18 to 80 years', 'Patients Aged']","['Alteplase', 'alteplase', 'placebo']","['good functional outcome', 'good stroke outcome (modified Rankin Scale score', '90-day mortality', 'Good stroke outcome']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.126515,"Among patients aged >80 years, alteplase versus placebo was associated with a higher proportion of good stroke outcome (modified Rankin Scale score 0-1; 99/518 [19.1%] versus 67/510 [13.1%];  P =0.0109) and similar 90-day mortality (153/518 [29.5%] versus 154/510 [30.2%];  P =0.8382).","[{'ForeName': 'Erich', 'Initials': 'E', 'LastName': 'Bluhmki', 'Affiliation': 'ADB Building, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany and Hochschule Biberach, University of Applied Sciences, Germany (E.B.).'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Danays', 'Affiliation': 'The Medical Department, Boehringer Ingelheim France SAS, Reims (T.D.).'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Biegert', 'Affiliation': 'The Biostatistics and Data Sciences Corp, Boehringer Ingelheim Pharma GmbH & Co KG, Biberach, Germany (G.B.).'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Hacke', 'Affiliation': 'The Department of Neurology, University of Heidelberg, Germany (W.H.).'}, {'ForeName': 'Kennedy R', 'Initials': 'KR', 'LastName': 'Lees', 'Affiliation': 'The School of Medicine, Dentistry & Nursing, University of Glasgow, United Kingdom (K.R.L.).'}]",Stroke,['10.1161/STROKEAHA.119.028396']
1219,32616406,Diagnostic Assessment of Lower Urinary Tract Symptoms in Men Considering Prostate Surgery: A Noninferiority Randomised Controlled Trial of Urodynamics in 26 Hospitals.,"BACKGROUND


Prostate surgery can improve lower urinary tract symptoms (LUTS) by relieving bladder outlet obstruction (BOO). However, surgery is less effective without BOO, or if detrusor underactivity is present. Urodynamics (UDS) can identify BOO and measure detrusor activity, but evidence in clinical practice is lacking.
OBJECTIVE


Urodynamics for Prostate Surgery Trial: Randomised Evaluation of Assessment Methods (UPSTREAM) aimed to evaluate whether a care pathway including UDS would reduce surgery without increasing urinary symptoms.
DESIGN, SETTING, AND PARTICIPANTS


UPSTREAM is a pragmatic, noninferiority, randomised controlled trial in men with bothersome LUTS, in whom surgery was an option, in 26 hospitals in England (ISRCTN56164274).
INTERVENTION


Participants were randomised (1:1) to routine care (RC) diagnostic tests, or RC plus UDS.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS


The primary outcome was the International Prostate Symptom Score (IPSS; patient-reported outcome scale from 0 to 35 points) 18 mo after randomisation, with a noninferiority margin of 1 point. Urological surgery rates were a key secondary outcome. The primary outcome was compared between the arms using linear regression, analysed on an intention-to-treat basis.
RESULTS AND LIMITATIONS


Between October 2014 and December 2016, 820 men (median age 68 yr) were randomised (393 and 427 in the RC and UDS arms, respectively). The UDS arm showed noninferiority of the mean IPSSs (UDS 12.6; RC 13.1; adjusted difference at 18 mo -0.33 [95% confidence interval {CI} -1.47, +0.80]). In the UDS arm, 153/408 (38%) received surgery compared with 138/384 (36%) in the RC arm (adjusted odds ratio 1.05; 95% CI 0.77, 1.43). A total of 428 adverse events (UDS 234; RC 194) were recorded, with related events similar in both arms and 11 unrelated deaths.
CONCLUSIONS


In this population, the UDS randomised group was noninferior to RC for the IPSS but did not reduce surgical rates. This study shows that routine use of UDS in the evaluation of uncomplicated LUTS has a limited role and should be used selectively.
PATIENT SUMMARY


For men with uncomplicated lower urinary tract symptoms, symptom improvements after treatment and the number of operations performed are similar, irrespective of whether or not urodynamic tests are conducted in addition to routine tests. Accordingly, routine use of urodynamics has a limited role in this population group.",2020,"For men with uncomplicated lower urinary tract symptoms, symptom improvements after treatment and the number of operations performed are similar, irrespective of whether or not urodynamic tests are conducted in addition to routine tests.","['Men Considering Prostate Surgery', 'Prostate Surgery Trial', 'Between October 2014 and December 2016, 820 men (median age 68 yr', 'men with bothersome LUTS, in whom surgery was an option, in 26 hospitals in England (ISRCTN56164274', '26 Hospitals']","['routine care (RC) diagnostic tests, or RC plus UDS']","['surgical rates', 'International Prostate Symptom Score (IPSS; patient-reported outcome scale', 'intention-to-treat basis', 'mean IPSSs', 'Urological surgery rates']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0194790', 'cui_str': 'Operation on prostate'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0574785', 'cui_str': 'Lower urinary tract symptoms'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0014282', 'cui_str': 'England'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0430022', 'cui_str': 'Diagnostic procedure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0042059', 'cui_str': 'Urodynamics'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1998280', 'cui_str': 'International prostate symptom score'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3653764', 'cui_str': 'UROLOGICALS'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]",,0.422983,"For men with uncomplicated lower urinary tract symptoms, symptom improvements after treatment and the number of operations performed are similar, irrespective of whether or not urodynamic tests are conducted in addition to routine tests.","[{'ForeName': 'Marcus J', 'Initials': 'MJ', 'LastName': 'Drake', 'Affiliation': 'Translational Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK; Bristol Urological Institute, North Bristol NHS Trust, Bristol, UK. Electronic address: marcus.drake@bristol.ac.uk.'}, {'ForeName': 'Amanda L', 'Initials': 'AL', 'LastName': 'Lewis', 'Affiliation': 'Bristol Randomised Trials Collaboration (BRTC), Bristol Trials Centre, University of Bristol, Bristol, UK; Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Grace J', 'Initials': 'GJ', 'LastName': 'Young', 'Affiliation': 'Bristol Randomised Trials Collaboration (BRTC), Bristol Trials Centre, University of Bristol, Bristol, UK; Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Abrams', 'Affiliation': 'Bristol Urological Institute, North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Peter S', 'Initials': 'PS', 'LastName': 'Blair', 'Affiliation': 'Bristol Randomised Trials Collaboration (BRTC), Bristol Trials Centre, University of Bristol, Bristol, UK; Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Chapple', 'Affiliation': 'Sheffield Teaching Hospitals NHS Trust, Royal Hallamshire Hospital, Sheffield, UK.'}, {'ForeName': 'Cathryn M A', 'Initials': 'CMA', 'LastName': 'Glazener', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, Scotland, UK.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Horwood', 'Affiliation': 'Bristol Randomised Trials Collaboration (BRTC), Bristol Trials Centre, University of Bristol, Bristol, UK; Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'John S', 'Initials': 'JS', 'LastName': 'McGrath', 'Affiliation': 'University of Exeter Medical School, Exeter, UK.'}, {'ForeName': 'Sian', 'Initials': 'S', 'LastName': 'Noble', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Gordon T', 'Initials': 'GT', 'LastName': 'Taylor', 'Affiliation': 'University of Plymouth, Plymouth, UK.'}, {'ForeName': 'J Athene', 'Initials': 'JA', 'LastName': 'Lane', 'Affiliation': 'Bristol Randomised Trials Collaboration (BRTC), Bristol Trials Centre, University of Bristol, Bristol, UK; Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}]",European urology,['10.1016/j.eururo.2020.06.004']
1220,32580710,"Fasting in diabetes treatment (FIT) trial: study protocol for a randomised, controlled, assessor-blinded intervention trial on the effects of intermittent use of a fasting-mimicking diet in patients with type 2 diabetes.","BACKGROUND


Caloric restriction is an effective way to treat Type 2 diabetes (T2D). However, chronic and severe restriction of food intake is difficult to sustain and is known to promote slower metabolism. Intermittent and frequent fasting can exert similar metabolic effects, but may be even more challenging for most patients. A fasting-mimicking diet (FMD) is low in calories, sugars and proteins, but includes relatively high levels of plant based complex carbohydrates and healthy fats. The metabolic effects of such a diet mimic the benefits of water-only fasting. The effects of a FMD applied periodically in T2D patients are still unknown. The Fasting In diabetes Treatment (FIT) trial was designed to determine the effect of intermittent use (5 consecutive days a month during a year) of a FMD in T2D patients on metabolic parameters and T2D medication use compared to usual care.
METHODS


One hundred T2D patients from general practices in the Netherlands with a BMI ≥ 27 kg/m 2 , treated with lifestyle advice only or lifestyle advice plus metformin, will be randomised to receive the FMD plus usual care or usual care only. Primary outcomes are HbA1c and T2D medication dosage. Secondary outcomes are anthropometrics, blood pressure, plasma lipid profiles, quality of life, treatment satisfaction, metabolomics, microbiome composition, MRI data including cardiac function, fat distribution and ectopic fat storage, cost-effectiveness, and feasibility in clinical practice.
DISCUSSION


This study will establish whether monthly 5-day cycles of a FMD during a year improve metabolic parameters and/or reduce the need for medication in T2D. Furthermore, additional health benefits and the feasibility in clinical practice will be measured and a cost-effectiveness evaluation will be performed.
TRIAL REGISTRATION


The trial was registered on ClinicalTrials.gov. Identifier: NCT03811587. Registered 21th of January, 2019; retrospectively registered.",2020,This study will establish whether monthly 5-day cycles of a FMD during a year improve metabolic parameters and/or reduce the need for medication in T2D.,"['T2D patients from general practices in the Netherlands with a BMI\u2009≥\u200927\u2009kg/m 2 , treated with', 'T2D patients', 'One hundred', 'patients with type 2 diabetes']","['fasting-mimicking diet', 'lifestyle advice only or lifestyle advice plus metformin', 'FMD plus usual care or usual care only', 'FMD']","['anthropometrics, blood pressure, plasma lipid profiles, quality of life, treatment satisfaction, metabolomics, microbiome composition, MRI data including cardiac function, fat distribution and ectopic fat storage, cost-effectiveness, and feasibility in clinical practice', 'HbA1c and T2D medication dosage', 'Fasting']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C1278073', 'cui_str': 'Plasma lipid measurement'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1328813', 'cui_str': 'Metabolomics'}, {'cui': 'C1956108', 'cui_str': 'Microbiome'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0340464', 'cui_str': 'Ectopic beats'}, {'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}]",100.0,0.101727,This study will establish whether monthly 5-day cycles of a FMD during a year improve metabolic parameters and/or reduce the need for medication in T2D.,"[{'ForeName': 'Elske L', 'Initials': 'EL', 'LastName': 'van den Burg', 'Affiliation': 'Department of Public Health and Primary Care, Leiden University Medical Center (LUMC), Postzone V0-P, Postbus 9600, 2300 RC, Leiden, The Netherlands. e.l.van_den_burg@lumc.nl.'}, {'ForeName': 'Marjolein P', 'Initials': 'MP', 'LastName': 'Schoonakker', 'Affiliation': 'Department of Public Health and Primary Care, Leiden University Medical Center (LUMC), Postzone V0-P, Postbus 9600, 2300 RC, Leiden, The Netherlands.'}, {'ForeName': 'Petra G', 'Initials': 'PG', 'LastName': 'van Peet', 'Affiliation': 'Department of Public Health and Primary Care, Leiden University Medical Center (LUMC), Postzone V0-P, Postbus 9600, 2300 RC, Leiden, The Netherlands.'}, {'ForeName': 'M Elske', 'Initials': 'ME', 'LastName': 'van den Akker-van Marle', 'Affiliation': 'Department of Biomedical Data Sciences, Medical Decision Making, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Ko', 'Initials': 'K', 'LastName': 'Willems van Dijk', 'Affiliation': 'Internal Medicine, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Valter D', 'Initials': 'VD', 'LastName': 'Longo', 'Affiliation': 'FIRC Institute of Molecular Oncology, Milan, Italy.'}, {'ForeName': 'Hildo J', 'Initials': 'HJ', 'LastName': 'Lamb', 'Affiliation': 'Radiology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Mattijs E', 'Initials': 'ME', 'LastName': 'Numans', 'Affiliation': 'Department of Public Health and Primary Care, Leiden University Medical Center (LUMC), Postzone V0-P, Postbus 9600, 2300 RC, Leiden, The Netherlands.'}, {'ForeName': 'Hanno', 'Initials': 'H', 'LastName': 'Pijl', 'Affiliation': 'Internal Medicine, Leiden University Medical Center, Leiden, the Netherlands.'}]",BMC endocrine disorders,['10.1186/s12902-020-00576-7']
1221,32588153,"Effects of Daikenchuto on postoperative gastrointestinal motility in colorectal carcinoma patients with abdominal pain and distension: a prospective, randomized trial.","PURPOSE


To investigate the efficacy and safety of Daikenchuto (DKT) for colorectal cancer patients undergoing surgery with the potential risk of postoperative ileus (POI).
METHODS


Colorectal cancer patients with abdominal pain and distention, scheduled for surgery, were randomly assigned to a DKT group or a control group. Patients assigned to the DKT group were given 15 g of DKT per day during the perioperative period. We then compared the perioperative gastrointestinal symptoms between the two groups.
RESULTS


The aim for a sample size of 30 patients per group was not reached in time, so we conducted an analysis on 16 patients in each group. The visual Analogue Scale scores for abdominal pain and distention were similar in the two groups. The number of bowel movements per day on postoperative days (PODs) 1, 2, and 6 were significantly lower in the DKT group. The incidence of a sensation of incomplete bowel evacuation on PODs 3 and 28 was also significantly lower in the DKT group. There were no adverse events thought to be related to DKT.
CONCLUSIONS


DKT could potentially inhibit diarrhea and reduce the number of bowel movements per day and the sensation of incomplete bowel evacuation after colorectal surgery. Thus, the perioperative use of DKT may be safe for colorectal cancer patients with abdominal pain and distention, who undergo surgery.",2020,The incidence of a sensation of incomplete bowel evacuation on PODs 3 and 28 was also significantly lower in the DKT group.,"['colorectal carcinoma patients with abdominal pain and distension', 'Colorectal cancer patients with abdominal pain and distention, scheduled for surgery', '30 patients per group was not reached in time, so we conducted an analysis on 16 patients in each group', 'colorectal cancer patients with abdominal pain and distention, who undergo surgery', 'colorectal cancer patients undergoing surgery with the potential risk of postoperative ileus (POI']","['DKT', 'Daikenchuto (DKT', 'Daikenchuto']","['perioperative gastrointestinal symptoms', 'visual Analogue Scale scores for abdominal pain and distention', 'postoperative gastrointestinal motility', 'number of bowel movements', 'incidence of a sensation of incomplete bowel evacuation']","[{'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0400877', 'cui_str': 'Postoperative ileus'}]","[{'cui': 'C0909027', 'cui_str': 'dai-kenchu-to'}]","[{'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0017184', 'cui_str': 'Gastrointestinal Motility'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0426639', 'cui_str': 'Incomplete passage of stool'}]",,0.0528345,The incidence of a sensation of incomplete bowel evacuation on PODs 3 and 28 was also significantly lower in the DKT group.,"[{'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Wakasugi', 'Affiliation': 'Department of Surgery, Osaka Police Hospital, 10-31 Kitayama-cho, Tennouji-ku, Osaka, 543-0035, Japan. wakasugimasaki@gmail.com.'}, {'ForeName': 'Yozo', 'Initials': 'Y', 'LastName': 'Suzuki', 'Affiliation': 'Department of Surgery, Osaka Police Hospital, 10-31 Kitayama-cho, Tennouji-ku, Osaka, 543-0035, Japan.'}, {'ForeName': 'Mitsuyoshi', 'Initials': 'M', 'LastName': 'Tei', 'Affiliation': 'Department of Surgery, Osaka Police Hospital, 10-31 Kitayama-cho, Tennouji-ku, Osaka, 543-0035, Japan.'}, {'ForeName': 'Shigeyuki', 'Initials': 'S', 'LastName': 'Ueshima', 'Affiliation': 'Department of Surgery, Osaka Police Hospital, 10-31 Kitayama-cho, Tennouji-ku, Osaka, 543-0035, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Akamatsu', 'Affiliation': 'Department of Surgery, Osaka Police Hospital, 10-31 Kitayama-cho, Tennouji-ku, Osaka, 543-0035, Japan.'}, {'ForeName': 'Toshirou', 'Initials': 'T', 'LastName': 'Nishida', 'Affiliation': 'Department of Surgery, Osaka Police Hospital, 10-31 Kitayama-cho, Tennouji-ku, Osaka, 543-0035, Japan.'}]",Surgery today,['10.1007/s00595-020-02052-0']
1222,32590520,"Radiographical Comparison of Superior and Inferior Gluteal Vessels in ""Jackknife"" Versus Prone Positions: A Prospective, Self-Controlled Trial.","BACKGROUND


Mortality after gluteal augmentation with fat transfer techniques is extremely high. Placement of fat subcutaneously versus in the gluteal musculature, or both, are considerably debated. The purpose of this study was to radiographically show the anatomical difference in live subjects in different procedural positions: the flexed or ""Jack-knife"" versus prone positions.
METHODS


A total of ten females underwent Computerized Tomography (CT) scanning of the pelvis with venous phase run-off in both the ""Jack-knife"" and prone positions. A CT specialized radiologist then reviewed images and measured distances from the inferior and superior gluteal veins (IGV and SGV, respectively) to the skin and muscle. Three-dimensional (3D) imaging and analysis were also performed.
RESULTS


Measurements were significantly shorter with respect to distance from skin to muscle, skin to vessel, and vessel to muscle observed from IGV and SGV in the ""Jack-knife"" versus the prone positions. 3D modeling showed a significant reduction in the volume and SGV and IGV diameters when in the ""Jack-knife"" position.
CONCLUSIONS


When placed in the ""Jack-knife"" position for gluteal augmentation with fat transfer, extreme caution should be taken with the injecting cannula as the underlying muscle is only 2-3 centimeters deep. 3D analysis showed narrowed and reduced volume of gluteal vasculature when in the ""Jack-knife"" position; a possible indication of torsion or stretch on the vessel around the pelvic rim that could cause vein avulsion injury from the pressurized fat within the piriform space.",2020,"RESULTS


Measurements were significantly shorter with respect to distance from skin to muscle, skin to vessel, and vessel to muscle observed from IGV and SGV in the ""Jack-knife"" versus the prone positions.","['Jackknife"" Versus Prone Positions']","['Computerized Tomography (CT) scanning', 'flexed or ""Jack-knife"" versus prone positions']","['volume of gluteal vasculature', 'volume and SGV and IGV diameters']","[{'cui': 'C0033422', 'cui_str': 'Prone body position'}]","[{'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0181467', 'cui_str': 'Knife'}, {'cui': 'C0033422', 'cui_str': 'Prone body position'}]","[{'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0005839', 'cui_str': 'blood supply'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}]",10.0,0.0267786,"RESULTS


Measurements were significantly shorter with respect to distance from skin to muscle, skin to vessel, and vessel to muscle observed from IGV and SGV in the ""Jack-knife"" versus the prone positions.","[{'ForeName': 'Connor W', 'Initials': 'CW', 'LastName': 'Barnes', 'Affiliation': ''}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Ford', 'Affiliation': ''}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Harrington', 'Affiliation': ''}, {'ForeName': 'Rajendra P', 'Initials': 'RP', 'LastName': 'Kedar', 'Affiliation': ''}, {'ForeName': 'Thanh Q', 'Initials': 'TQ', 'LastName': 'Tran', 'Affiliation': ''}, {'ForeName': 'Rachel A', 'Initials': 'RA', 'LastName': 'Karlnoski', 'Affiliation': ''}, {'ForeName': 'Summer J', 'Initials': 'SJ', 'LastName': 'Decker', 'Affiliation': ''}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Smith', 'Affiliation': ''}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000007151']
1223,32592335,Treatment of oral lichen planus with mucoadhesive mycophenolate mofetil patch: A randomized clinical trial.,"OBJECTIVES


Oral lichen planus (OLP) is a chronic inflammatory disease of unknown etiology which is known as a premalignant disease. A complete cure has not been found for this condition. Mycophenolate mofetil (MMF) is a new drug that seems to be effective in improving OLP lesions. But there are no studies on the efficacy of mucoadhesive form of MMF in ulcerative OLP. Therefore, this study was performed to determine the therapeutic effect of MMF mucoadhesive on OLP lesions.
MATERIAL AND METHODS


Twenty-seven patients with OLP, were enrolled in two groups. All the patients were instructed to place the MMF 2% mucoadhesive on the lesion twice daily for 4 weeks. Lesion size was measured by a sterile digital caulis (mm) and the severity of burning sensation and pain by visual analogue scale (VAS; cm) at baseline and weekly follow-ups.
RESULTS


There was no significant difference in burning sensation and lesion size at Weeks 1, 2, and 3 in both groups. In Group A, at Week 4, there was significant reduction in pain and burning sensation and lesion size on both sides (p = .048, .012). The difference in lesion size on control sides was not significant. In Group B, at Week 4, there was significant reduction in pain and burning sensation and lesion size (p = .004). No side effects were reported by the patients.
CONCLUSIONS


Based on the results, 2% MMF mucoadhesive was effective in decreasing burning sensation and pain severity and ulcer size of ulcerative OLP and the effect was time-dependent.",2020,"In Group A, at Week 4, there was significant reduction in pain and burning sensation and lesion size on both sides (p = .048, .012).","['Twenty-seven patients with OLP, were enrolled in two groups']","['Mycophenolate mofetil (MMF', 'Oral lichen planus (OLP', 'MMF mucoadhesive', 'mucoadhesive mycophenolate mofetil patch']","['burning sensation and lesion size', 'lesion size on control sides', 'burning sensation and pain severity and ulcer size of ulcerative OLP', 'severity of burning sensation and pain by visual analogue scale (VAS; cm', 'Lesion size', 'pain and burning sensation and lesion size', 'side effects']","[{'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206139', 'cui_str': 'Oral lichen planus'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}, {'cui': 'C0206139', 'cui_str': 'Oral lichen planus'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}]","[{'cui': 'C0085624', 'cui_str': 'Burning sensation'}, {'cui': 'C0449453', 'cui_str': 'Lesion size'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441987', 'cui_str': 'Side'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0206139', 'cui_str': 'Oral lichen planus'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",27.0,0.0435425,"In Group A, at Week 4, there was significant reduction in pain and burning sensation and lesion size on both sides (p = .048, .012).","[{'ForeName': 'Negin', 'Initials': 'N', 'LastName': 'Samiee', 'Affiliation': 'Post Graduate Student of Oral and Maxillofacial Medicine, Oral and Maxillofacial Medicine Department, Mashhad Dental Faculty, Mashhad, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Taghavi Zenuz', 'Affiliation': 'Department of Oral and Maxillofacial Medicine, School of Dentistry, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Masumeh', 'Initials': 'M', 'LastName': 'Mehdipour', 'Affiliation': 'Department of Oral and Maxillofacial Medicine, School of Dentistry, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Javad', 'Initials': 'J', 'LastName': 'Shokri', 'Affiliation': 'Department of Pharmaceutics, School of Pharmacy, Tabriz University of Medical Sciences, Tabriz, Iran.'}]",Clinical and experimental dental research,['10.1002/cre2.302']
1224,31834239,"Effect of Intravenous Aminocaproid Acid on Blood Loss and Transfusion Requirements After Bilateral Varus Rotational Osteotomy: A Double-blind, Placebo-controlled Randomized Trial.","BACKGROUND


ε-Aminocaproic acid (EACA) is an antifibrinolytic agent that has been shown to decrease blood loss and transfusion requirements in several populations undergoing various surgical procedures. However, the efficacy of EACA has not been assessed in pediatric patients with cerebral palsy undergoing bilateral varus rotational femoral osteotomies. The purpose of this study was to assess the efficacy of intravenous EACA in reducing calculated intraoperative blood loss and transfusions in this population.
METHODS


Patients aged 18 years or younger were eligible. Patients were randomized to receive EACA or placebo (saline), and randomization was stratified based on sex and whether or not additional soft tissue or osseous procedures were performed. On the basis of retrospective data, the calculated sample size was 12 patients per arm to detect a difference of 250-mL blood loss. The primary outcome was calculated intraoperative blood loss. Secondary outcomes included transfusion requirements, 24-hour drain output, length of stay, and incidence of complications.
RESULTS


The mean age of patients in this study was 8 years (SD: 2.4 y). There were no differences in age, sex, height, weight, type of anesthesia, operative time, and associated procedures between the EACA and placebo groups (P>0.05). Preoperative hematocrit was lower in the EACA group (37.1 vs. 40.0, P=0.04). Calculated intraoperative blood loss was 536 mL in the EACA group and 628 mL in the placebo group (P=0.45). Transfusions were required in 62% of patients in the EACA group and 67% of patients in the placebo group (P=0.68). Total 24-hour drain output was 72.5 mL in the EACA group and 103.3 mL in the placebo group (P=0.37). Length of stay was similar between both groups, and there were no drug or placebo-related complications in either group.
CONCLUSIONS


There was no difference in blood loss or transfusion requirements associated with EACA compared with placebo; however, this study is underpowered to detect smaller differences in blood loss. Additional studies with larger sample sizes are needed to confirm these findings and further elucidate the indications for antifibrinolytic agents in pediatric patients.
LEVEL OF EVIDENCE


Level I.",2019,Transfusions were required in 62% of patients in the EACA group and 67% of patients in the placebo group (P=0.68).,"['several populations undergoing various surgical procedures', 'pediatric patients', 'After Bilateral Varus Rotational Osteotomy', 'Patients aged 18 years or younger were eligible', 'pediatric patients with cerebral palsy undergoing bilateral varus rotational femoral osteotomies']","['Placebo', 'ε-Aminocaproic acid (EACA', 'EACA', 'EACA or placebo (saline', 'Intravenous Aminocaproid Acid', 'placebo']","['Length of stay', 'blood loss or transfusion requirements', 'Total 24-hour drain output', 'Preoperative hematocrit', '250-mL blood loss', 'Blood Loss and Transfusion Requirements', 'blood loss and transfusion requirements', 'Transfusions', 'calculated intraoperative blood loss', 'transfusion requirements, 24-hour drain output, length of stay, and incidence of complications', 'blood loss', 'Calculated intraoperative blood loss']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0443345', 'cui_str': 'Varus'}, {'cui': 'C0407433', 'cui_str': 'Rotational osteotomy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0445237', 'cui_str': 'Rotational'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0029468', 'cui_str': 'Osteotomy'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0000608', 'cui_str': '6-Aminocaproic Acid'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0001128', 'cui_str': 'Acid'}]","[{'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0013103', 'cui_str': 'Drainage procedure'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",,0.423115,Transfusions were required in 62% of patients in the EACA group and 67% of patients in the placebo group (P=0.68).,"[{'ForeName': 'Ishaan', 'Initials': 'I', 'LastName': 'Swarup', 'Affiliation': ""Division of Pediatric Orthopaedic Surgery, University of California, San Francisco, UCSF Benioff Children's Hospital Oakland, Oakland, CA.""}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Nguyen', 'Affiliation': 'Healthcare Research Institute.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Edmonds', 'Affiliation': 'Division of Anesthesiology.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Dodwell', 'Affiliation': 'Division of Pediatric Orthopaedic Surgery, Hospital for Special Surgery, New York, NY.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Scher', 'Affiliation': 'Division of Pediatric Orthopaedic Surgery, Hospital for Special Surgery, New York, NY.'}]",Journal of pediatric orthopedics,['10.1097/BPO.0000000000001480']
1225,32602376,Sleep problems worsen health-related quality of life and participation during the first 12 months of stroke rehabilitation.,"OBJECTIVE


Evaluate the impact of self-reported sleep problems on post-stroke recovery.
DESIGN


Cross-sectional secondary analysis of longitudinal data from the Locomotor Experience Applied Post-Stroke (LEAPS) rehabilitation and recovery study (phase-III single-blind randomized controlled clinical trial). Group medians were compared for three sleep problem groups across three time points.
SETTING


Outpatient and in-home physical therapy.
SUBJECTS


Adults during the first year following stroke ( n  = 408, 380, 360 at 2, 6, 12 months, respectively).
INTERVENTIONS


The original study compared effects of locomotor training with body weight support in the year post-stroke. This analysis evaluated function in three sleep/functional-impact groups: no sleep problems, sleep problems with no-to-minimal-impact and sleep problems with moderate-to-quite-a-bit of impact.
MAIN MEASURES


Participants' responses regarding if they had ""a sleep problem, such as insomnia"" and, if so, what the impact was on their function. Stroke Impact Scale subscales for strength, hand function, mobility, ADLs, memory, communication, emotion, participation, and percent recovery.
RESULTS


About 25% of people with stroke reported sleep difficulty, 10% perceived sleep problems negatively impact function. Groups self-reporting worse sleep performed worse in all functional subscales (except self-perceived percent recovery) during the first year post-stroke.
CONCLUSION


Self-reported poor sleep adversely effects post-stroke functional recovery.",2020,"Groups self-reporting worse sleep performed worse in all functional subscales (except self-perceived percent recovery) during the first year post-stroke.
","['Adults during the first year following stroke ( n \u2009=\u2009408, 380, 360 at 2, 6, 12\u2009months, respectively', 'Outpatient and in-home physical therapy']","['locomotor training with body weight support', 'Locomotor Experience Applied Post-Stroke (LEAPS) rehabilitation']","['Stroke Impact Scale subscales for strength, hand function, mobility, ADLs, memory, communication, emotion, participation, and percent recovery']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C4517769', 'cui_str': '408'}, {'cui': 'C4319693', 'cui_str': '380'}, {'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}]","[{'cui': 'C0419113', 'cui_str': 'Locomotor training'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0562230', 'cui_str': 'Hand functions'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0439165', 'cui_str': 'Percent'}]",,0.0806525,"Groups self-reporting worse sleep performed worse in all functional subscales (except self-perceived percent recovery) during the first year post-stroke.
","[{'ForeName': 'George', 'Initials': 'G', 'LastName': 'Fulk', 'Affiliation': 'SUNY Upstate Medical University, Syracuse, NY, USA.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Duncan', 'Affiliation': 'Wake Forest University Health Sciences, Wake Forest, NC, USA.'}, {'ForeName': 'Karen J', 'Initials': 'KJ', 'LastName': 'Klingman', 'Affiliation': 'SUNY Upstate Medical University, Syracuse, NY, USA.'}]",Clinical rehabilitation,['10.1177/0269215520935940']
1226,32609069,Comparison of two forced-air warming device during foot and ankle surgery: A randomised controlled trial.,"Inadvertent perioperative hypothermia is a frequent problem associated with surgical patients which can have significant consequences during surgery and in the immediate postoperative period. We compared 35 randomised patients using over vs. under body forced air heating. There were no statistically significant differences between some demographic and surgical parameters such as: age, weight, height, body mass index, length of anaesthesia and operation. Statistically significant differences were found between the patient's admission to the operating room and 30 minutes and the end of the procedure on the under body patients group. This study analyses a uniform population of patients (Foot and Ankle Surgery) previously not studied and supports the use of under body blankets.",2020,"There were no statistically significant differences between some demographic and surgical parameters such as: age, weight, height, body mass index, length of anaesthesia and operation.","['35 randomised patients using over vs. under body forced air heating', 'during foot and ankle surgery']",['two forced-air warming device'],"['age, weight, height, body mass index, length of anaesthesia and operation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0018851', 'cui_str': 'Heating'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0188412', 'cui_str': 'Operative procedure on ankle'}]","[{'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]",35.0,0.0509046,"There were no statistically significant differences between some demographic and surgical parameters such as: age, weight, height, body mass index, length of anaesthesia and operation.","[{'ForeName': 'Jorge Javier', 'Initials': 'JJ', 'LastName': 'Del Vecchio', 'Affiliation': 'Head Foot and Ankle Section, Orthopaedics Department, Hospital Universitario - Fundación Favaloro, Ciudad Autónoma de Buenos Aires (CABA), Argentina.'}, {'ForeName': 'Lucas Nicolás', 'Initials': 'LN', 'LastName': 'Chemes', 'Affiliation': 'Department of Kinesiology and Physiatry, Universidad Favaloro, Buenos Aires, Argentina.'}, {'ForeName': 'Mauricio Esteban', 'Initials': 'ME', 'LastName': 'Ghioldi', 'Affiliation': 'Department of Kinesiology and Physiatry, Universidad Favaloro, Buenos Aires, Argentina.'}, {'ForeName': 'Eric Daniel', 'Initials': 'ED', 'LastName': 'Dealbera', 'Affiliation': 'Foot and Ankle Section, Fundación Favaloro - Hospital Universitario, Buenos Aires, Argentina.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Daniel Morgillo', 'Affiliation': 'Foot and Ankle Surgery and Limb Salvage Fellowship, Foot and Ankle Section, Fundación Favaloro - Hospital Universitario, Buenos Aires, Argentina.'}]",Journal of perioperative practice,['10.1177/1750458920927286']
1227,32605881,Reducing metabolic syndrome through a community-based lifestyle intervention in African American women.,"BACKGROUND AND AIMS


Metabolic syndrome (MetS) increases the risk of cardiovascular disease and type 2 diabetes. Despite a higher prevalence of MetS in African American (AA) women, little is known about the effectiveness of lifestyle interventions in improving metabolic markers in this high-risk group. This study investigated the effectiveness of a community-based lifestyle intervention delivered by lay health coaches in reducing MetS among AA women.
METHODS AND RESULTS


A cluster-randomized diabetes prevention program (DPP) was implemented in 11 churches utilizing a community-based participatory research (CBPR) approach to develop and deliver the interventions. A total of 221 adults, AA women who were overweight or obese, and did not have diabetes were included in this study. The prevalence of MetS was 42.08% before receiving the DPP intervention and 31.22% after the intervention that represented a 10.86% absolute reduction and a 25.81% relative reduction from baseline. The adjusted odds ratio (OR) of being free from MetS at post-intervention in contrast to baseline was 2.14 (p = 0.02). Factors that increased the odds of being free from MetS were younger age, reduction in intake of total calories, total fat, saturated and trans-fat, and dietary sodium.
CONCLUSION


A faith adapted lifestyle intervention held in church settings and delivered by minimally trained lay health coaches reduced the prevalence of MetS in AA women who were overweight or obese. Findings from this study can be used to translate evidence into public health programs at the community level for the prevention of type 2 diabetes and cardiovascular disease.
CLINICAL TRIAL REGISTRATION NUMBER


NCT04082702 (www.clinicaltrials.gov).",2020,A faith adapted lifestyle intervention held in church settings and delivered by minimally trained lay health coaches reduced the prevalence of MetS in AA women who were overweight or obese.,"['African American (AA) women', 'AA women', 'African American women', '11 churches utilizing a community-based participatory research (CBPR', '221 adults, AA women who were overweight or obese, and did not have diabetes were included in this study', 'AA women who were overweight or obese']","['diabetes prevention program (DPP', 'community-based lifestyle intervention']","['adjusted odds ratio (OR) of being free from MetS', 'prevalence of MetS']","[{'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0562324', 'cui_str': 'Church'}, {'cui': 'C2350575', 'cui_str': 'Community-Based Participatory Research'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}]",221.0,0.0456853,A faith adapted lifestyle intervention held in church settings and delivered by minimally trained lay health coaches reduced the prevalence of MetS in AA women who were overweight or obese.,"[{'ForeName': 'Abdullah', 'Initials': 'A', 'LastName': 'Mamun', 'Affiliation': 'Baylor Scott and White Health and Wellness Center, Dallas, TX, USA. Electronic address: abdullah.mamun@bswhealth.org.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Kitzman', 'Affiliation': 'Baylor Scott and White Health and Wellness Center, Dallas, TX, USA; University of North Texas Health Science Center, Fort Worth, TX, USA; Baylor University, Waco, TX, USA.'}, {'ForeName': 'Leilani', 'Initials': 'L', 'LastName': 'Dodgen', 'Affiliation': 'Baylor Scott and White Health and Wellness Center, Dallas, TX, USA; University of North Texas Health Science Center, Fort Worth, TX, USA.'}]","Nutrition, metabolism, and cardiovascular diseases : NMCD",['10.1016/j.numecd.2020.06.005']
1228,32605885,Functional pasta consumption in healthy volunteers modulates ABCG1-mediated cholesterol efflux capacity of HDL.,"BACKGROUNDS AND AIMS


Prevention of cardiovascular (CV) disease is considered a central issue in public health and great attention is payed to nutritional approaches, including consumption of functional foods to reduce CV risk in individuals without indications for anti-atherosclerotic drugs. Cholesterol efflux capacity (CEC) is an important anti-atherogenic property of HDL and a marker of CV risk. We evaluated the effect of a daily consumption of an innovative whole-wheat synbiotic pasta, compared to a control whole-wheat pasta, on serum ATP binding cassette G1 (ABCG1)-mediated CEC in healthy overweight or obese individuals.
METHODS AND RESULTS


Study participants (n = 41) were randomly allocated to either innovative or control pasta, consumed daily for twelve weeks. Serum CEC was measured before and after the dietary intervention, by a well-established radioisotopic technique on Chinese Hamster Ovary Cells transfected with human ABCG1. The innovative synbiotic pasta consumption was associated to a significantly higher post treatment/baseline ratio of ABCG1-mediated CEC values with respect to control pasta (mean ratio 1.05 ± 0.037 and 0.95 ± 0.042 respectively, p < 0.05). Analysis of the relationship between ABCG1-mediated CEC and glycemia, homocysteine, total folates and interleukin-6 showed specific changes in the correlations between HDL function and glycemia, oxidative and inflammatory markers only after synbiotic pasta consumption.
CONCLUSION


This is the first report on serum CEC improvement obtained by a new synbiotic functional pasta consumption, in absence of lipid profile modifications, in overweight/obese participants. This pilot study suggests that a simple dietary intervention can be a promising approach to CV preservation through improving of athero-protective HDL function.",2020,"The innovative synbiotic pasta consumption was associated to a significantly higher post treatment/baseline ratio of ABCG1-mediated CEC values with respect to control pasta (mean ratio 1.05 ± 0.037 and 0.95 ± 0.042 respectively, p < 0.05).","['healthy overweight or obese individuals', 'Study participants (n\xa0=\xa041', 'healthy volunteers', 'overweight/obese participants']",['innovative or control pasta'],"['Serum CEC', 'Cholesterol efflux capacity (CEC', 'ABCG1-mediated CEC and glycemia, homocysteine, total folates and interleukin-6', 'HDL function and glycemia, oxidative and inflammatory markers']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0452694', 'cui_str': 'Pasta'}]","[{'cui': 'C0587184', 'cui_str': 'Serum cholesterol measurement'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0001480', 'cui_str': 'Adenosine Triphosphate'}, {'cui': 'C0332297', 'cui_str': 'Bounded by'}, {'cui': 'C0450240', 'cui_str': 'Cassette'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0019878', 'cui_str': 'Homocysteine'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",41.0,0.0354418,"The innovative synbiotic pasta consumption was associated to a significantly higher post treatment/baseline ratio of ABCG1-mediated CEC values with respect to control pasta (mean ratio 1.05 ± 0.037 and 0.95 ± 0.042 respectively, p < 0.05).","[{'ForeName': 'Elda', 'Initials': 'E', 'LastName': 'Favari', 'Affiliation': 'Department of Food and Drug, University of Parma, Parma, Italy.'}, {'ForeName': 'Donato', 'Initials': 'D', 'LastName': 'Angelino', 'Affiliation': 'Department of Food and Drug, University of Parma, Parma, Italy.'}, {'ForeName': 'Eleonora', 'Initials': 'E', 'LastName': 'Cipollari', 'Affiliation': 'Department of Food and Drug, University of Parma, Parma, Italy.'}, {'ForeName': 'Maria Pia', 'Initials': 'MP', 'LastName': 'Adorni', 'Affiliation': 'Department of Food and Drug, University of Parma, Parma, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Zimetti', 'Affiliation': 'Department of Food and Drug, University of Parma, Parma, Italy.'}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Bernini', 'Affiliation': 'Department of Food and Drug, University of Parma, Parma, Italy.'}, {'ForeName': 'Nicoletta', 'Initials': 'N', 'LastName': 'Ronda', 'Affiliation': 'Department of Food and Drug, University of Parma, Parma, Italy. Electronic address: nicoletta.ronda@unipr.it.'}, {'ForeName': 'Nicoletta', 'Initials': 'N', 'LastName': 'Pellegrini', 'Affiliation': 'Department of Food and Drug, University of Parma, Parma, Italy.'}]","Nutrition, metabolism, and cardiovascular diseases : NMCD",['10.1016/j.numecd.2020.05.002']
1229,32612355,Safety of a Combined WB-EMS and High-Protein Diet Intervention in Sarcopenic Obese Elderly Men.,"Purpose


Whole-body electromyostimulation (WB-EMS) especially in combination with a high-protein supplementation has been established as an efficient treatment against sarcopenia. However, there are several case reports of rhabdomyolysis after WB-EMS application. Thus, we asked if this training could potentially lead to deteriorations of the cardiac as well as the renal function.
Materials and Methods


One hundred sarcopenic obese men aged 70 years and older were randomly balanced (1-1-1) and allocated to one of the three study arms. During 16 weeks of intervention, these groups either performed WB-EMS and took a protein supplement (WB-EMS&P), solely received the protein supplement (Protein) or served as control group (CG). WB-EMS consisted of 1.5×20 min (85 Hz, 350 μs, 4 s of strain to 4 s of rest) applied with moderate-to-high intensity while moving. We further generated a daily protein intake of 1.7-1.8 g/kg/body mass per day. At baseline and 8-10 days after completion of the intervention, blood was drawn and biomarkers of muscle, cardiac and renal health were assessed.
Results


Hereby, we found slight but significant elevations of creatine kinase (CK) levels in the WB-EMS group pointing to minor damages of the skeletal muscle (140 U/l [81-210], p < 0.001). This was accompanied by a significant, low-grade increase of creatine kinase-muscle brain (CK-MB, 0.43 ng/mL [-0.29-0.96], p < 0.01) and high-sensitivity troponin T (hsTnT, 0.001 ng/mL. [0.000-0.003], p < 0.001) but without a higher risk of developing heart failure according to N-terminal prohormone of brain natriuretic peptide (NT-proBNP, -5.7 pg/mL [-38.8-24.6], p = 0.17). Estimated glomerular filtration rate (eGFR) was impaired neither by the high-protein supplementation alone nor in combination with WB-EMS (CG 76.0 mL/min/1.73 m 2  [71.9-82.2] vs Protein 73.2 mL/min/1.73 m 2  [63.0-78.9] vs WB-EMS&P 74.6 mL/min/1.73 m 2  [62.8-84.1], p = 0.478).
Conclusion


In conclusion, even in the vulnerable group of sarcopenic obese seniors, the combination of WB-EMS with a high-protein intake revealed no short-term, negative impact on the eGFR, but potential consequences for the cardiovascular system need to be addressed in future studies.",2020,Estimated glomerular filtration rate (eGFR) was impaired neither by the high-protein supplementation alone nor in combination with WB-EMS (CG 76.0 mL/min/1.73 m 2  [71.9-82.2] vs,"['hundred sarcopenic obese men aged 70 years and older', 'Sarcopenic Obese Elderly Men']","['WB-EMS and took a protein supplement (WB-EMS&P), solely received the protein supplement (Protein) or served as control group (CG', 'Combined WB-EMS and High-Protein Diet Intervention']","['Estimated glomerular filtration rate (eGFR', 'high-sensitivity troponin T', 'creatine kinase (CK) levels']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0524337', 'cui_str': 'Elderly man'}]","[{'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0038164', 'cui_str': 'Protein A'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0770246', 'cui_str': 'Protein supplementation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0077404', 'cui_str': 'Troponin T'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0281486,Estimated glomerular filtration rate (eGFR) was impaired neither by the high-protein supplementation alone nor in combination with WB-EMS (CG 76.0 mL/min/1.73 m 2  [71.9-82.2] vs,"[{'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Kemmler', 'Affiliation': 'Institute of Medical Physics, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'von Stengel', 'Affiliation': 'Institute of Medical Physics, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Kohl', 'Affiliation': 'Faculty of Medical and Life Science, University of Furtwangen, Schwenningen, Germany.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Rohleder', 'Affiliation': 'Institute of Psychology, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bertsch', 'Affiliation': 'Institute of Clinical Chemistry, Laboratory Medicine and Transfusion Medicine, General Hospital Nuremberg, Paracelsus Medical University, Nuremberg, Germany.'}, {'ForeName': 'Cornel C', 'Initials': 'CC', 'LastName': 'Sieber', 'Affiliation': 'Institute for Biomedicine of Aging, Friedrich-Alexander-Universität Erlangen-Nürnberg, Nuremberg, Germany.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Freiberger', 'Affiliation': 'Institute for Biomedicine of Aging, Friedrich-Alexander-Universität Erlangen-Nürnberg, Nuremberg, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Kob', 'Affiliation': 'Institute for Biomedicine of Aging, Friedrich-Alexander-Universität Erlangen-Nürnberg, Nuremberg, Germany.'}]",Clinical interventions in aging,['10.2147/CIA.S248868']
1230,32615179,Early precut versus primary precut sphincterotomy to reduce post-ERCP pancreatitis: randomized controlled trial (with videos).,"BACKGROUND AND AIMS


Precut sphincterotomy, usually performed after prolonged and failed cannulation, is considered a risk factor for post-ERCP pancreatitis (PEP). There are limited studies on primary needle-knife precut for the prevention of PEP. The aim of this study was to assess the safety and efficacy of primary precut.
METHODS


A randomized controlled trial was conducted in a tertiary care setting on patients who underwent ERCP. Patients were randomized to very early precut (group A, precut after 2 failed attempts of wire-guided sphincterotome cannulation) and primary precut (group B, direct needle-knife precut). All procedures were done by an experienced endoscopist. The primary outcome of the study was to compare the incidence of PEP between the 2 groups.
RESULTS


Three hundred three patients were randomized to group A (n = 152, age 48.2 ± 15.4 years, 61 men) and group B (n = 151, age 46.7 ± 13.8 years, 65 men). There was no significant difference in baseline characteristics and indications for ERCP between the 2 groups. Development of PEP (5.2% vs .67%; P = .04) and asymptomatic hyperamylasemia (12.5% vs 2.6%; P = .01) were lower in group B compared with group A. The bile duct cannulation time (13.8 ± 2.2 vs 7.2 ± 1.7 minutes; P = .001) was lower in group B, whereas the overall cannulation success rate (98% vs 98.6%; P = 1.0) was similar in both the groups.
CONCLUSIONS


Primary precut by an experienced endoscopist results in low risk of PEP. (Clinical trial registration number: CTRI/2017/08/009510.).",2020,Development of PEP (5.2% vs 0.67%; p = 0.04) and asymptomatic hyperamylasemia (12.5% vs 2.6%; p = 0.01) were lower in group B compared with group A.,"['patients who underwent ERCP', 'Three hundred three patients were randomized to group A (n= 152, age 48.2±15.4 years, 61 men) and group B (n= 151, age 46.7±13.8 years, 65 men']","['wire guided sphincterotome cannulation) and primary precut (group B: direct needle-knife precut', 'Early precut versus primary precut sphincterotomy']","['asymptomatic hyperamylasemia', 'safety and efficacy', 'bile duct cannulation time', 'incidence of PEP', 'low risk of PEP', 'overall cannulation success rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008310', 'cui_str': 'Endoscopic retrograde cholangiopancreatography'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}]","[{'cui': 'C0181089', 'cui_str': 'Guide wire'}, {'cui': 'C0183424', 'cui_str': 'Sphincterotome'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0441189', 'cui_str': 'Direct needle'}, {'cui': 'C0181467', 'cui_str': 'Knife'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0177047', 'cui_str': 'Sphincterotomy (bladder)'}]","[{'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0221773', 'cui_str': 'Hyperamylasaemia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0005400', 'cui_str': 'Bile duct structure'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0008310', 'cui_str': 'Endoscopic retrograde cholangiopancreatography'}, {'cui': 'C0030305', 'cui_str': 'Pancreatitis'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",303.0,0.106841,Development of PEP (5.2% vs 0.67%; p = 0.04) and asymptomatic hyperamylasemia (12.5% vs 2.6%; p = 0.01) were lower in group B compared with group A.,"[{'ForeName': 'Sudhir', 'Initials': 'S', 'LastName': 'Maharshi', 'Affiliation': 'Department of Gastroenterology, SMS Medical College and Hospitals, Jaipur, India.'}, {'ForeName': 'Shyam Sunder', 'Initials': 'SS', 'LastName': 'Sharma', 'Affiliation': 'Department of Gastroenterology, SMS Medical College and Hospitals, Jaipur, India.'}]",Gastrointestinal endoscopy,['10.1016/j.gie.2020.06.064']
1231,32616559,Provider visual attention on a respiratory function monitor during neonatal resuscitation.,"BACKGROUND


A respiratory function monitor (RFM) provides real-time positive pressure ventilation feedback. Whether providers use RFM during neonatal resuscitation is unknown.
METHODS


Ancillary study to the MONITOR(NCT03256578) randomised controlled trial. Neonatal resuscitation leaders at two centres wore eye-tracking glasses, and visual attention (VA) patterns were compared between RFM-visible and RFM-masked groups.
RESULTS


14 resuscitations (6 RFM-visible, 8 RFM-masked) were analysed. The median total gaze duration on the RFM was significantly higher with a visible RFM (29% vs 1%, p<0.01), while median total gaze duration on other physical objects was significantly lower with a visible RFM (3% vs 8%, p=0.02). Median total gaze duration on the infant was lower with RFM visible, although not statistically significantly (29% vs 46%, p=0.05).
CONCLUSION


Providers' VA patterns differed during neonatal resuscitation when the RFM was visible, emphasising the importance of studying the impact of additional delivery room technology on providers' behaviour.",2020,"Median total gaze duration on the infant was lower with RFM visible, although not statistically significantly (29% vs 46%, p=0.05).
",['neonatal resuscitation'],['Provider visual attention'],"['median total gaze duration on other physical objects', 'Median total gaze duration', 'median total gaze duration on the RFM']","[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}]","[{'cui': 'C0589102', 'cui_str': 'Visual attention'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0553544', 'cui_str': 'Gaze'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0347997', 'cui_str': 'Physical object'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}]",,0.061549,"Median total gaze duration on the infant was lower with RFM visible, although not statistically significantly (29% vs 46%, p=0.05).
","[{'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Herrick', 'Affiliation': ""Department of Pediatrics, Division of Neonatology, The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA herrickh@email.chop.edu.""}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Weinberg', 'Affiliation': ""Department of Pediatrics, Division of Neonatology, The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.""}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Cecarelli', 'Affiliation': 'Nursing, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Claire E', 'Initials': 'CE', 'LastName': 'Fishman', 'Affiliation': 'University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Haley', 'Initials': 'H', 'LastName': 'Newman', 'Affiliation': ""Department of Pediatrics, The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.""}, {'ForeName': 'Maria C', 'Initials': 'MC', 'LastName': 'den Boer', 'Affiliation': 'Neonatology, Leiden University Medical Center, Leiden, Zuid-Holland, The Netherlands.'}, {'ForeName': 'Tessa', 'Initials': 'T', 'LastName': 'Martherus', 'Affiliation': 'Neonatology, Leiden University Medical Center, Leiden, Zuid-Holland, The Netherlands.'}, {'ForeName': 'Trixie A', 'Initials': 'TA', 'LastName': 'Katz', 'Affiliation': 'Neonatology, Amsterdam University Medical Centres, Amsterdam, The Netherlands.'}, {'ForeName': 'Vinay', 'Initials': 'V', 'LastName': 'Nadkarni', 'Affiliation': ""Anesthesiology and Critical Care Medicine, The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.""}, {'ForeName': 'Arjan B', 'Initials': 'AB', 'LastName': 'Te Pas', 'Affiliation': 'Neonatology, Leiden University Medical Center, Leiden, Zuid-Holland, The Netherlands.'}, {'ForeName': 'Elizabeth E', 'Initials': 'EE', 'LastName': 'Foglia', 'Affiliation': ""Department of Pediatrics, Division of Neonatology, The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.""}]",Archives of disease in childhood. Fetal and neonatal edition,['10.1136/archdischild-2020-319291']
1232,32619561,"ERGO2: A Prospective, Randomized Trial of Calorie-Restricted Ketogenic Diet and Fasting in Addition to Reirradiation for Malignant Glioma.","PURPOSE


ERGO2 is the first randomized clinical trial on a calorically restricted ketogenic diet (KD) and intermittent fasting (KD-IF) in addition to reirradiation for recurrent malignant gliomas.
METHODS AND MATERIALS


Fifty patients were randomized 1:1 to reirradiation combined with either a calorically unrestricted diet or KD-IF. The KD-IF schedule included 3 days of KD (21-23 kcal/kg/d), followed by 3 days of fasting and again 3 days of KD. Primary endpoint was progression-free survival (PFS) at 6 months (PFS6). Secondary endpoints were PFS, local PFS, overall survival (OS), frequency of epileptic seizures, rate of ketosis and quality of life.
RESULTS


Four patients quit the trial before treatment and 3 patients stopped KD-IF prematurely. Of the 20 patients who completed KD-IF, 17 patients developed ketosis at day 6 and glucose levels declined significantly. KD-IF was well-tolerated with a modest weight loss of -2.1 ± 1.8 kg. No severe adverse events attributable to the diet occurred. PFS6 was not significantly different between the 2 groups (KD-IF: 20%; calorically unrestricted diet: 16%). Similarly, no difference in PFS, local PFS6, or OS was observable. Explorative analysis revealed that patients in the KD-IF group who had a glucose level of less than the median (83.5 mg/dL) on day 6 had significantly longer PFS and OS compared with those above the median (P < .05).
CONCLUSIONS


KD-IF is feasible and effective in inducing ketosis in heavily pretreated patients with recurrent glioma. However, the short schedule reported here failed to increase the efficacy of reirradiation. CLINICALTRIALS.
GOV NUMBER


NCT01754350.",2020,"PFS6 was not significantly different between the two groups (KD-IF: 20%, SD: 16%).","['50 Patients', 'heavily pretreated patients with recurrent glioma', 'malignant glioma']","['calorie restricted ketogenic diet and fasting in addition to re-irradiation', 're-irradiation combined with either calorically unrestricted diet (SD) or KD-IF', 'ERGO2', 'calorically restricted ketogenic diet (KD) and intermittent fasting (KD-IF']","['ketosis at day 6 and glucose levels', 'progression-free survival (PFS) rate at 6 months (PFS6', 'severe adverse events', 'PFS, local PFS, overall survival (OS), frequency of epileptic seizures, rate of ketosis and quality of life', 'PFS6', 'PFS, local PFS6 and OS', 'PFS and OS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0017638', 'cui_str': 'Glioma'}, {'cui': 'C0555198', 'cui_str': 'Glioma, malignant, no ICD-O subtype'}]","[{'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0259972', 'cui_str': 'Ketogenic diet'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4042794', 'cui_str': 'Re Irradiation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C4704881', 'cui_str': 'Intermittent Fasting'}]","[{'cui': 'C0022638', 'cui_str': 'Ketosis'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",50.0,0.0608039,"PFS6 was not significantly different between the two groups (KD-IF: 20%, SD: 16%).","[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Voss', 'Affiliation': 'Dr Senckenberg Institute of Neurooncology, University Hospital Frankfurt, Goethe University, Frankfurt, Germany; University Cancer Center Frankfurt, University Hospital Frankfurt, Goethe University, Frankfurt, Germany; German Cancer Consortium, Partner Site Frankfurt, and German Cancer Research Center, Heidelberg, Germany; Frankfurt Cancer Institute, Frankfurt, Germany. Electronic address: martin.voss@kgu.de.'}, {'ForeName': 'Marlies', 'Initials': 'M', 'LastName': 'Wagner', 'Affiliation': 'University Cancer Center Frankfurt, University Hospital Frankfurt, Goethe University, Frankfurt, Germany; German Cancer Consortium, Partner Site Frankfurt, and German Cancer Research Center, Heidelberg, Germany; Frankfurt Cancer Institute, Frankfurt, Germany; Institute of Neuroradiology, University Hospital Frankfurt, Goethe University, Frankfurt, Germany.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'von Mettenheim', 'Affiliation': 'Dr Senckenberg Institute of Neurooncology, University Hospital Frankfurt, Goethe University, Frankfurt, Germany; University Cancer Center Frankfurt, University Hospital Frankfurt, Goethe University, Frankfurt, Germany; German Cancer Consortium, Partner Site Frankfurt, and German Cancer Research Center, Heidelberg, Germany; Frankfurt Cancer Institute, Frankfurt, Germany.'}, {'ForeName': 'Patrick N', 'Initials': 'PN', 'LastName': 'Harter', 'Affiliation': 'University Cancer Center Frankfurt, University Hospital Frankfurt, Goethe University, Frankfurt, Germany; German Cancer Consortium, Partner Site Frankfurt, and German Cancer Research Center, Heidelberg, Germany; Frankfurt Cancer Institute, Frankfurt, Germany; Institute of Neurology (Edinger-Institute), University Hospital Frankfurt, Goethe University, Frankfurt, Germany.'}, {'ForeName': 'Katharina J', 'Initials': 'KJ', 'LastName': 'Wenger', 'Affiliation': 'University Cancer Center Frankfurt, University Hospital Frankfurt, Goethe University, Frankfurt, Germany; German Cancer Consortium, Partner Site Frankfurt, and German Cancer Research Center, Heidelberg, Germany; Frankfurt Cancer Institute, Frankfurt, Germany; Institute of Neuroradiology, University Hospital Frankfurt, Goethe University, Frankfurt, Germany.'}, {'ForeName': 'Kea', 'Initials': 'K', 'LastName': 'Franz', 'Affiliation': 'University Cancer Center Frankfurt, University Hospital Frankfurt, Goethe University, Frankfurt, Germany; German Cancer Consortium, Partner Site Frankfurt, and German Cancer Research Center, Heidelberg, Germany; Frankfurt Cancer Institute, Frankfurt, Germany; Department of Neurosurgery, University Hospital Frankfurt, Goethe University, Frankfurt, Germany.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Bojunga', 'Affiliation': 'Department of Medicine 1, University Hospital Frankfurt, Goethe University, Frankfurt, Germany.'}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Vetter', 'Affiliation': 'Dr Senckenberg Institute of Neurooncology, University Hospital Frankfurt, Goethe University, Frankfurt, Germany; University Cancer Center Frankfurt, University Hospital Frankfurt, Goethe University, Frankfurt, Germany; German Cancer Consortium, Partner Site Frankfurt, and German Cancer Research Center, Heidelberg, Germany; Frankfurt Cancer Institute, Frankfurt, Germany.'}, {'ForeName': 'Ruediger', 'Initials': 'R', 'LastName': 'Gerlach', 'Affiliation': 'Department of Neurosurgery, HELIOS Hospital Erfurt, Erfurt, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Glatzel', 'Affiliation': 'Department of Radiation Oncology, HELIOS Hospital Erfurt, Erfurt, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Paulsen', 'Affiliation': 'Department of Radiation Oncology, University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'Elke', 'Initials': 'E', 'LastName': 'Hattingen', 'Affiliation': 'University Cancer Center Frankfurt, University Hospital Frankfurt, Goethe University, Frankfurt, Germany; German Cancer Consortium, Partner Site Frankfurt, and German Cancer Research Center, Heidelberg, Germany; Frankfurt Cancer Institute, Frankfurt, Germany; Institute of Neuroradiology, University Hospital Frankfurt, Goethe University, Frankfurt, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Baehr', 'Affiliation': 'Dr Senckenberg Institute of Neurooncology, University Hospital Frankfurt, Goethe University, Frankfurt, Germany; University Cancer Center Frankfurt, University Hospital Frankfurt, Goethe University, Frankfurt, Germany; German Cancer Consortium, Partner Site Frankfurt, and German Cancer Research Center, Heidelberg, Germany; Frankfurt Cancer Institute, Frankfurt, Germany.'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Ronellenfitsch', 'Affiliation': 'Dr Senckenberg Institute of Neurooncology, University Hospital Frankfurt, Goethe University, Frankfurt, Germany; University Cancer Center Frankfurt, University Hospital Frankfurt, Goethe University, Frankfurt, Germany; German Cancer Consortium, Partner Site Frankfurt, and German Cancer Research Center, Heidelberg, Germany; Frankfurt Cancer Institute, Frankfurt, Germany.'}, {'ForeName': 'Emmanouil', 'Initials': 'E', 'LastName': 'Fokas', 'Affiliation': 'University Cancer Center Frankfurt, University Hospital Frankfurt, Goethe University, Frankfurt, Germany; German Cancer Consortium, Partner Site Frankfurt, and German Cancer Research Center, Heidelberg, Germany; Frankfurt Cancer Institute, Frankfurt, Germany; Department of Radiotherapy and Oncology, University Hospital Frankfurt, Goethe University, Frankfurt, Germany.'}, {'ForeName': 'Detlef', 'Initials': 'D', 'LastName': 'Imhoff', 'Affiliation': 'University Cancer Center Frankfurt, University Hospital Frankfurt, Goethe University, Frankfurt, Germany; German Cancer Consortium, Partner Site Frankfurt, and German Cancer Research Center, Heidelberg, Germany; Frankfurt Cancer Institute, Frankfurt, Germany; Department of Radiotherapy and Oncology, University Hospital Frankfurt, Goethe University, Frankfurt, Germany.'}, {'ForeName': 'Joachim P', 'Initials': 'JP', 'LastName': 'Steinbach', 'Affiliation': 'Dr Senckenberg Institute of Neurooncology, University Hospital Frankfurt, Goethe University, Frankfurt, Germany; University Cancer Center Frankfurt, University Hospital Frankfurt, Goethe University, Frankfurt, Germany; German Cancer Consortium, Partner Site Frankfurt, and German Cancer Research Center, Heidelberg, Germany; Frankfurt Cancer Institute, Frankfurt, Germany.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Rödel', 'Affiliation': 'University Cancer Center Frankfurt, University Hospital Frankfurt, Goethe University, Frankfurt, Germany; German Cancer Consortium, Partner Site Frankfurt, and German Cancer Research Center, Heidelberg, Germany; Frankfurt Cancer Institute, Frankfurt, Germany; Department of Radiotherapy and Oncology, University Hospital Frankfurt, Goethe University, Frankfurt, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Rieger', 'Affiliation': 'Dr Senckenberg Institute of Neurooncology, University Hospital Frankfurt, Goethe University, Frankfurt, Germany; Interdisciplinary Division of Neuro-Oncology, University Hospital Tübingen, Tübingen, Germany.'}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2020.06.021']
1233,32619630,Effectiveness of a self-rehabilitation program to improve upper-extremity function after stroke in developing countries: A randomized controlled trial.,"BACKGROUND


About two-thirds of stroke patients present long-term upper-limb impairment and limitations of activity, which constitutes a challenge in rehabilitation. This situation is particularly true in developing countries, where there is a need for inexpensive rehabilitation solutions.
OBJECTIVE


This study assessed the effectiveness of a self-rehabilitation program including uni- or bi-manual functional exercises for improving upper-limb function after stroke with respect to the context in Benin, West Africa.
METHODS


In this single-blind randomized controlled trial, chronic stroke individuals (>6 months post-stroke) performed a supervised home-based self-rehabilitation program for 8 weeks (intervention group); the control group did not receive any treatment. Participants were assessed before treatment (T0), at the end of treatment (T1) and 8 weeks after the end of treatment (T2). The primary outcome was the manual ability of the upper limb, assessed with ABILHAND-Stroke Benin. Secondary outcomes were grip force, motor impairment (Fugl-Meyer Assessment - Upper Extremity), gross manual ability (Box and Block test, Wolf Motor Function test) and quality of life (WHOQOL-26).
RESULTS


We included 28 individuals in the intervention group and 31 in the control group. Adherence to the program was 83%. After 8 weeks of self-rehabilitation, individuals in the intervention group showed significantly improved manual ability and grip force as compared with the control group (P<0.001), with effect size 0.75 and 0.24, respectively. In the intervention group, the difference in average scores was 10% between T0 and T1 and between T0 and T2. Subscores of physical and psychological quality of life were also significantly improved in the intervention group. The other variables remained unchanged.
CONCLUSIONS


A self-rehabilitation program was effective in improving manual ability, grip force and quality of life in individuals with stroke in Benin. More studies are needed to confirm these results in different contexts.",2020,"CONCLUSIONS


A self-rehabilitation program was effective in improving manual ability, grip force and quality of life in individuals with stroke in Benin.","['after stroke in developing countries', 'chronic stroke individuals (> 6 months post-stroke', 'individuals with stroke in Benin', '28 individuals in the intervention group and 31 in the control group']","['control group did not receive any treatment', 'self-rehabilitation program', 'self-rehabilitation program including uni- or bimanual functional exercises', 'supervised home-based self-rehabilitation program']","['manual ability of the upper limb, assessed with ABILHAND Stroke Benin', 'upper-extremity function', 'Subscores of physical and psychological quality of life', 'average scores', 'manual ability, grip force and quality of life', 'grip force, motor impairment (Fugl-Meyer Assessment-Upper Extremity), gross manual ability (Box and Block test, Wolf Motor Function test) and quality of life (WHOQOL-26', 'manual ability and grip force']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0011750', 'cui_str': 'Less-Developed Countries'}, {'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0005005', 'cui_str': 'Benin'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C3853222', 'cui_str': 'Sea urchin - dietary'}, {'cui': 'C0454284', 'cui_str': 'Functional exercises'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0005005', 'cui_str': 'Benin'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0220843', 'cui_str': 'Grasp'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0439806', 'cui_str': 'Gross'}, {'cui': 'C0006080', 'cui_str': 'Boxing'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0325001', 'cui_str': 'Wolf'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}]",,0.0722415,"CONCLUSIONS


A self-rehabilitation program was effective in improving manual ability, grip force and quality of life in individuals with stroke in Benin.","[{'ForeName': 'Ditouah Didier', 'Initials': 'DD', 'LastName': 'Niama Natta', 'Affiliation': 'Physical medicine and rehabilitation department, National university hospital of Cotonou, Cotonou, Benin; NMSK lab, Institut de recherche expérimentale et clinique (IREC), UCLouvain, Brussels, Belgium.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Lejeune', 'Affiliation': 'NMSK lab, Institut de recherche expérimentale et clinique (IREC), UCLouvain, Brussels, Belgium; Physical medicine and rehabilitation department, cliniques universitaires Saint-Luc, Brussels, Belgium; Louvain Bionics, UCLouvain, Louvain-La-Neuve, Belgium.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Detrembleur', 'Affiliation': 'NMSK lab, Institut de recherche expérimentale et clinique (IREC), UCLouvain, Brussels, Belgium; Louvain Bionics, UCLouvain, Louvain-La-Neuve, Belgium.'}, {'ForeName': 'Berenice', 'Initials': 'B', 'LastName': 'Yarou', 'Affiliation': 'Physical medicine and rehabilitation department, National university hospital of Cotonou, Cotonou, Benin.'}, {'ForeName': 'Emmanuel S', 'Initials': 'ES', 'LastName': 'Sogbossi', 'Affiliation': 'Physical medicine and rehabilitation department, National university hospital of Cotonou, Cotonou, Benin.'}, {'ForeName': 'Etienne', 'Initials': 'E', 'LastName': 'Alagnidé', 'Affiliation': 'Physical medicine and rehabilitation department, National university hospital of Cotonou, Cotonou, Benin.'}, {'ForeName': 'Toussaint', 'Initials': 'T', 'LastName': 'Kpadonou', 'Affiliation': 'Physical medicine and rehabilitation department, National university hospital of Cotonou, Cotonou, Benin.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Selves', 'Affiliation': 'NMSK lab, Institut de recherche expérimentale et clinique (IREC), UCLouvain, Brussels, Belgium; Physical medicine and rehabilitation department, cliniques universitaires Saint-Luc, Brussels, Belgium; Louvain Bionics, UCLouvain, Louvain-La-Neuve, Belgium.'}, {'ForeName': 'Gaëtan', 'Initials': 'G', 'LastName': 'Stoquart', 'Affiliation': 'NMSK lab, Institut de recherche expérimentale et clinique (IREC), UCLouvain, Brussels, Belgium; Physical medicine and rehabilitation department, cliniques universitaires Saint-Luc, Brussels, Belgium; Louvain Bionics, UCLouvain, Louvain-La-Neuve, Belgium. Electronic address: gaetan.stoquart@uclouvain.be.'}]",Annals of physical and rehabilitation medicine,['10.1016/j.rehab.2020.03.017']
1234,32621374,Impact of Point-of-care Testing on Length of Stay of Patients in the Emergency Department: A Cluster-randomized Controlled Study.,"OBJECTIVES


Crowding is a frequent concern in the emergency department (ED). Laboratory point-of-care testing (POCT) has been proposed to decrease patients' length of stay (LOS). Our objective was to determine whether an extended panel of POCT solutions could reduce LOS.
METHODS


This was a single-center, prospective, open-label, controlled cluster-randomized study. Blood test processing was randomized into 1-week inclusion periods: interventional arm (laboratory analyses performed on POCT analyzers implemented in the ED) or control arm (central laboratory). The primary endpoint was LOS of patients in the ED. Secondary endpoints were time to result (TTR), ED crowding surrogates, and average total cost of an ED visit in each arm.
RESULTS


A total of 23,231 patients were included and 20,923 were analyzed for the main outcome measure. Mean ± SD age was 46 ± 20 years, and 7,905 (36%) underwent blood sampling. Mean ± SD LOSs were 203 ± 161 and 210 ± 168 minutes in the POCT and control arms, respectively. LOS reduction for the entire ED population was -9 minutes (95% confidence interval [CI] = -22 to 5, p = 0.22) compared to the control arm and -17 minutes (95% CI = -34.0 to 0.6, p = 0.06) for patients undergoing blood sampling. The mean ± SD TTRs were 28 ± 31 and 79 ± 34 minutes in the POCT and control arms, respectively (TTR reduction = -51 minutes, 95% CI = -54 to -48 minutes, p < 0.001).
CONCLUSIONS


The implementation of an extended panel of POCT solutions in an ED did not significantly reduce the LOS, but reduced the TTR.",2020,"Mean LOS was 203 ± 161 and 210 ± 168 minutes (min) in the POCT arm and control arm, respectively.","['Mean age was 46 ± 20 years, and 7,905 (36%) underwent blood sampling', 'of patients in the emergency department', 'A total of 23,231 patients']","['care testing (POCT', 'care testing']","['LOS reduction', 'LOS', 'length of stay', ""patients' length of stay (LOS"", 'time to result (TTR), ED crowding surrogates, and average total cost of an ED visit in each arm', 'TTR reduction']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005834', 'cui_str': 'Collection of blood specimen for laboratory'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C1319069', 'cui_str': 'Point of care testing'}]","[{'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]",23231.0,0.138528,"Mean LOS was 203 ± 161 and 210 ± 168 minutes (min) in the POCT arm and control arm, respectively.","[{'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Hausfater', 'Affiliation': 'From the, Emergency Department, Hôpital Pitié-Salpêtrière, APHP, Paris, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hajage', 'Affiliation': 'the, Département Biostatistique Santé Publique et Information Médicale, Centre de Pharmacoépidémiologie (Cephepi), Sorbonne Université, APHP, Paris, France.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Bulsei', 'Affiliation': ""the, AP-HP URC Eco Ile de France Hôpital de l'Hôtel Dieu, Paris, France.""}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Canavaggio', 'Affiliation': 'From the, Emergency Department, Hôpital Pitié-Salpêtrière, APHP, Paris, France.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Lafourcade', 'Affiliation': 'the, Unité de Recherche Clinique Salpêtrière-Charles Foix, APHP, Paris, France.'}, {'ForeName': 'Anne Laure', 'Initials': 'AL', 'LastName': 'Paquet', 'Affiliation': 'From the, Emergency Department, Hôpital Pitié-Salpêtrière, APHP, Paris, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Arock', 'Affiliation': 'the, Sorbonne Université, Paris, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Durand-Zaleski', 'Affiliation': ""the, AP-HP URC Eco Ile de France Hôpital de l'Hôtel Dieu, Paris, France.""}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Riou', 'Affiliation': 'From the, Emergency Department, Hôpital Pitié-Salpêtrière, APHP, Paris, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Oueidat', 'Affiliation': 'and the, Biochemisty and Emergency Biology Department, Hôpital Pitié-Salpêtrière, APHP, Paris, France.'}]",Academic emergency medicine : official journal of the Society for Academic Emergency Medicine,['10.1111/acem.14072']
1235,32623487,A single dose of zoledronate preserves bone mineral density for up to 2 years after a second course of romosozumab.,"This phase 2 study evaluated the efficacy and safety of transitioning to zoledronate following romosozumab treatment in postmenopausal women with low bone mass. A single dose of 5 mg zoledronate generally maintained the robust BMD gains accrued with romosozumab treatment and was well tolerated.
INTRODUCTION


Follow-on therapy with an antiresorptive agent is necessary to maintain the skeletal benefits of romosozumab therapy. We evaluated the use of zoledronate following romosozumab treatment.
METHODS


This phase 2, dose-finding study enrolled postmenopausal women with low bone mineral density (BMD). Subjects who received various romosozumab doses or placebo from months 0-24 were rerandomized to denosumab (60 mg SC Q6M) or placebo for 12 months, followed by open-label romosozumab (210 mg QM) for 12 months. At month 48, subjects who had received active treatment for 48 months were assigned to no further active treatment and all other subjects were assigned to zoledronate 5 mg IV. Efficacy (BMD, P1NP, and β-CTX) and safety were evaluated for 24 months, up to month 72.
RESULTS


A total of 141 subjects entered the month 48-72 period, with 51 in the no further active treatment group and 90 in the zoledronate group. In subjects receiving no further active treatment, lumbar spine (LS) BMD decreased by 10.8% from months 48-72 but remained 4.2% above the original baseline. In subjects receiving zoledronate, LS BMD was maintained (percentage changes: - 0.8% from months 48-72; 12.8% from months 0-72). Similar patterns were observed for proximal femur BMD in both groups. With no further active treatment, P1NP and β-CTX decreased but remained above baseline at month 72. Following zoledronate, P1NP and β-CTX levels initially decreased but approached baseline by month 72. No new safety signals were observed.
CONCLUSION


A zoledronate follow-on regimen can maintain robust BMD gains achieved with romosozumab treatment.",2020,"Following zoledronate, P1NP and β-CTX levels initially decreased but approached baseline by month 72.","['141 subjects entered the month 48-72 period, with 51 in the no further active treatment group and 90 in the zoledronate group', 'postmenopausal women with low bone mass', 'enrolled postmenopausal women with low bone mineral density (BMD', 'At month 48, subjects who had received active treatment for 48\xa0months']","['zoledronate 5\xa0mg IV', 'romosozumab treatment', 'various romosozumab doses or placebo', 'denosumab', 'zoledronate', 'placebo']","['bone mineral density', 'proximal femur BMD', 'P1NP and β-CTX', 'β-CTX levels', 'tolerated', 'BMD gains', 'efficacy and safety', 'Efficacy (BMD, P1NP, and β-CTX) and safety', 'LS BMD', 'lumbar spine (LS) BMD']","[{'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0392938', 'cui_str': 'Zoledronate'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}]","[{'cui': 'C0392938', 'cui_str': 'Zoledronate'}, {'cui': 'C3661283', 'cui_str': 'romosozumab'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1690432', 'cui_str': 'denosumab'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0072053', 'cui_str': 'Procollagen peptide, type 1 N-terminal'}, {'cui': 'C0010377', 'cui_str': 'Crotoxin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}]",141.0,0.0281302,"Following zoledronate, P1NP and β-CTX levels initially decreased but approached baseline by month 72.","[{'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'McClung', 'Affiliation': 'Oregon Osteoporosis Center, 2881 NW Cumberland Road, Portland, OR 97210, USA. mmcclung.ooc@gmail.com.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Bolognese', 'Affiliation': 'Bethesda Health Research Center, Bethesda, MD, USA.'}, {'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Brown', 'Affiliation': 'Laval University and CHU de Québec (CHUL) Research Centre, Québec City, QC, Canada.'}, {'ForeName': 'J-Y', 'Initials': 'JY', 'LastName': 'Reginster', 'Affiliation': 'University of Liège, Liège, Belgium.'}, {'ForeName': 'B L', 'Initials': 'BL', 'LastName': 'Langdahl', 'Affiliation': 'Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Maddox', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rojeski', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'P D', 'Initials': 'PD', 'LastName': 'Meisner', 'Affiliation': 'UCB Pharma, Brussels, Belgium.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Grauer', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}]",Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA,['10.1007/s00198-020-05502-0']
1236,32623977,Sex Differences in Blood Pressure-Lowering Therapy and Outcomes Following Intracerebral Hemorrhage: Results From ATACH-2.,"BACKGROUND AND PURPOSE


Evidence regarding sex differences in clinical outcomes and treatment effect following intracerebral hemorrhage is limited. Using the ATACH-2 trial (Antihypertensive Treatment in Intracerebral Hemorrhage-2) data, we explored whether sex disparities exist in outcomes and response to intensive blood pressure (BP)-lowering therapy.
METHODS


Eligible intracerebral hemorrhage subjects were randomly assigned to intensive (target systolic BP, 110-139 mm Hg) or standard (140-179 mm Hg) BP-lowering therapy within 4.5 hours after onset. Relative risk of death or disability corresponding to the modified Rankin Scale score of 4 to 6 was calculated, and interaction between sex and treatment was explored.
RESULTS


In total, 380 women and 620 men were included. Women were older, more prescribed antihypertensive drugs before onset, and had more lobar intracerebral hemorrhage than men. Hematoma expansion was observed less in women. After multivariable adjustment, the relative risk of death or disability in women was 1.19 (95% CI, 1.02-1.37,  P =0.023). The relative risk of death or disability between intensive versus standard BP-lowering therapy was 0.91 (95% CI, 0.74-1.13) in women versus 1.13 (95% CI, 0.92-1.39) in men ( P  for interaction=0.11), with inconclusive Gail-Simmon test ( P =0.16).
CONCLUSIONS


Women had a higher risk of death or disability following intracerebral hemorrhage. The benefit of intensive BP-lowering therapy in women is inconclusive, consistent with the overall results of ATACH-2. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01176565.",2020,"The relative risk of death or disability between intensive versus standard BP-lowering therapy was 0.91 (95% CI, 0.74-1.13) in women versus 1.13 (95% CI, 0.92-1.39) in men (","['Eligible intracerebral hemorrhage subjects', '380 women and 620 men were included', 'Women were older, more prescribed antihypertensive drugs before onset, and had more lobar intracerebral hemorrhage than men']","['intensive BP-lowering therapy', 'Hg) BP-lowering therapy']","['Hematoma expansion', 'risk of death or disability', 'relative risk of death or disability', 'Relative risk of death or disability corresponding to the modified Rankin Scale score']","[{'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C4319693', 'cui_str': '380'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4708788', 'cui_str': '620'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}]","[{'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",380.0,0.38882,"The relative risk of death or disability between intensive versus standard BP-lowering therapy was 0.91 (95% CI, 0.74-1.13) in women versus 1.13 (95% CI, 0.92-1.39) in men (","[{'ForeName': 'Mayumi', 'Initials': 'M', 'LastName': 'Fukuda-Doi', 'Affiliation': 'Department of Cerebrovascular Medicine (M.F.-D., M.K., S.Y., K.M., K.T.), National Cerebral and Cardiovascular Center, Suita, Japan.'}, {'ForeName': 'Haruko', 'Initials': 'H', 'LastName': 'Yamamoto', 'Affiliation': 'Center for Advancing Clinical and Translational Sciences (M.F.-D., H.Y.), National Cerebral and Cardiovascular Center, Suita, Japan.'}, {'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Koga', 'Affiliation': 'Department of Cerebrovascular Medicine (M.F.-D., M.K., S.Y., K.M., K.T.), National Cerebral and Cardiovascular Center, Suita, Japan.'}, {'ForeName': 'Yuko Y', 'Initials': 'YY', 'LastName': 'Palesch', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston (Y.Y.P., V.L.D.-M.).'}, {'ForeName': 'Valerie L', 'Initials': 'VL', 'LastName': 'Durkalski-Mauldin', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston (Y.Y.P., V.L.D.-M.).'}, {'ForeName': 'Adnan I', 'Initials': 'AI', 'LastName': 'Qureshi', 'Affiliation': 'Zeenat Qureshi Stroke Institute, St. Cloud, MN (A.I.Q.).'}, {'ForeName': 'Sohei', 'Initials': 'S', 'LastName': 'Yoshimura', 'Affiliation': 'Department of Cerebrovascular Medicine (M.F.-D., M.K., S.Y., K.M., K.T.), National Cerebral and Cardiovascular Center, Suita, Japan.'}, {'ForeName': 'Shuhei', 'Initials': 'S', 'LastName': 'Okazaki', 'Affiliation': 'Department of Neurology (S. Okazaki), National Cerebral and Cardiovascular Center, Suita, Japan.'}, {'ForeName': 'Kaori', 'Initials': 'K', 'LastName': 'Miwa', 'Affiliation': 'Department of Cerebrovascular Medicine (M.F.-D., M.K., S.Y., K.M., K.T.), National Cerebral and Cardiovascular Center, Suita, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Okada', 'Affiliation': 'Department of Cerebrovascular Medicine and Neurology, National Hospital Organization Kyushu Medical Center Clinical Research Institute, Fukuoka, Japan (Y.O.).'}, {'ForeName': 'Toshihiro', 'Initials': 'T', 'LastName': 'Ueda', 'Affiliation': 'Department of Strokology, Stroke Center, St. Marianna University Toyoko Hospital, Kawasaki, Japan (T.U.).'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Okuda', 'Affiliation': 'Department of Neurology, National Hospital Organization Nagoya Medical Center, Japan (S. Okuda).'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Nakahara', 'Affiliation': 'Department of Neurology, Keio University School of Medicine, Tokyo, Japan (M.F.-D., J.N., N.S., K.T.).'}, {'ForeName': 'Norihiro', 'Initials': 'N', 'LastName': 'Suzuki', 'Affiliation': 'Department of Neurology, Keio University School of Medicine, Tokyo, Japan (M.F.-D., J.N., N.S., K.T.).'}, {'ForeName': 'Kazunori', 'Initials': 'K', 'LastName': 'Toyoda', 'Affiliation': 'Department of Cerebrovascular Medicine (M.F.-D., M.K., S.Y., K.M., K.T.), National Cerebral and Cardiovascular Center, Suita, Japan.'}]",Stroke,['10.1161/STROKEAHA.120.029770']
1237,32593918,Early initiated postoperative rehabilitation enhances quality of life in patients with operable lung cancer: Secondary outcomes from a randomized trial.,"INTRODUCTION


Patients with lung cancer report a lower degree of Health Related Quality of Life (HRQoL) compared with other cancer patients. HRQoL reflects how patients experience the impact of their disease and its treatment on their quality of daily living. A widely used questionnaire in lung cancer patients is the Functional Assessment of Cancer Therapy - Lung (FACT-L) questionnaire. Here we report the secondary outcomes on FACT-L data from the Postoperative Rehabilitation in Operation for Lung CAncer (PROLUCA) study, which describes the effect of early (14 days) versus late initiated (14 weeks) postoperative rehabilitation.
MATERIALS AND METHODS


The PROLUCA study was designed as a two-armed randomized controlled trial with an early rehabilitation group (14 days after surgery (ERG)) or a control arm with a late rehabilitation group (14 weeks after surgery (LRG)). The results for seven domain scores obtained using the FACT-L at the following time-points: baseline, 14 weeks, 26 weeks and 52 weeks after surgery are presented here.
RESULTS


119 patients were randomized to the ERG and 116 to the LRG. In the ERG, HRQoL measured by both FACT-L and FACT-G (general core instrument) showed a continuous improvement up to 26 weeks after which HRQoL decreased after further 26 weeks without structured intervention. In the LRG a non-significant deterioration was detected over the first 14 weeks after surgery. After participation in the 12 weeks rehabilitation program, an increase in HRQoL was seen, without reaching the same level as the early group.
CONCLUSION


Analyses of the seven domain scores obtained using FACT-L and FACT-G reflect the importance of starting exercise early after surgery since the ERG avoid a temporary decrease in HRQoL. It is therefore recommended to start up a structured rehabilitation program 14 days after surgery, containing high intensity interval training and strength exercise twice a week for 12 weeks.",2020,"After participation in the 12 weeks rehabilitation program, an increase in HRQoL was seen, without reaching the same level as the early group.
","['lung cancer patients', 'patients with operable lung cancer', '119 patients']","['postoperative rehabilitation', 'early rehabilitation group (14 days after surgery (ERG)) or a control arm with a late rehabilitation group']","['quality of life', 'Health Related Quality of Life (HRQoL', 'HRQoL']","[{'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205188', 'cui_str': 'Operable'}]","[{'cui': 'C0877071', 'cui_str': 'Postoperative rehabilitation'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0205087', 'cui_str': 'Late'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}]",119.0,0.0636671,"After participation in the 12 weeks rehabilitation program, an increase in HRQoL was seen, without reaching the same level as the early group.
","[{'ForeName': 'Maja Schick', 'Initials': 'MS', 'LastName': 'Sommer', 'Affiliation': 'Copenhagen Centre for Cancer and Health, Denmark. Electronic address: mss@kraeftcenter-kbh.dk.'}, {'ForeName': 'Jette', 'Initials': 'J', 'LastName': 'Vibe-Petersen', 'Affiliation': 'Copenhagen Centre for Cancer and Health, Denmark.'}, {'ForeName': 'Maja Bohlbro', 'Initials': 'MB', 'LastName': 'Stærkind', 'Affiliation': 'The University Hospitals for Health Sciences, University Hospital of Copenhagen, Denmark.'}, {'ForeName': 'Seppo W', 'Initials': 'SW', 'LastName': 'Langer', 'Affiliation': 'Department of Oncology, Copenhagen University Hospital, Rigshospitalet, Denmark.'}, {'ForeName': 'Klaus Richter', 'Initials': 'KR', 'LastName': 'Larsen', 'Affiliation': 'Bispebjerg-Frederiksberg Hospital, University of Copenhagen, Denmark.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Trier', 'Affiliation': 'Copenhagen Centre for Cancer and Health, Denmark.'}, {'ForeName': 'Merete', 'Initials': 'M', 'LastName': 'Christensen', 'Affiliation': 'Department of Cardiothoracic Surgery, Copenhagen University Hospital, Rigshospitalet, Denmark.'}, {'ForeName': 'Paul F', 'Initials': 'PF', 'LastName': 'Clementsen', 'Affiliation': 'Department of Internal Medicine, Zealand University Hospital, Roskilde, Denmark; Copenhagen Academy for Medical Education and Simulation, University of Copenhagen and the Capital Region of Copenhagen, Denmark; Department of Clinical Medicine, University of Copenhagen, Denmark.'}, {'ForeName': 'Malene', 'Initials': 'M', 'LastName': 'Missel', 'Affiliation': 'Department of Cardiothoracic Surgery, Copenhagen University Hospital, Rigshospitalet, Denmark.'}, {'ForeName': 'Karl Bang', 'Initials': 'KB', 'LastName': 'Christensen', 'Affiliation': 'Section of Biostatistics, Department of Public Health, University of Copenhagen, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Lillelund', 'Affiliation': 'The University Hospitals for Health Sciences, University Hospital of Copenhagen, Denmark.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Langberg', 'Affiliation': 'Department of Public Health, Faculty of Health, University of Copenhagen, Denmark.'}, {'ForeName': 'Jesper H', 'Initials': 'JH', 'LastName': 'Pedersen', 'Affiliation': 'Department of Cardiothoracic Surgery, Copenhagen University Hospital, Rigshospitalet, Denmark.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Quist', 'Affiliation': 'The University Hospitals for Health Sciences, University Hospital of Copenhagen, Denmark.'}]","Lung cancer (Amsterdam, Netherlands)",['10.1016/j.lungcan.2020.06.023']
1238,32599215,Who Enrolls in an Online Cancer Survivorship Program? Reach of the INSPIRE Randomized Controlled Trial for Hematopoietic Cell Transplantation Survivors.,"The internet can be a valuable tool in delivering survivorship care to hematopoietic cell transplantation (HCT) cancer survivors. We describe the reach of INSPIRE, an Internet and social media-based randomized controlled trial, to address healthcare and psychosocial needs of HCT survivors. All survivors 2-10 years after HCT for hematologic malignancy or myelodysplasia from 6 transplantation centers in the US were approached by mail and follow-up calls. Eligible participants had access to the Internet, an email address, and did not have active disease in the past 2 years. We used logistic regression to determine characteristics of eligible survivors who were more or less likely to enroll. Of 2578 eligible HCT survivors, 1065 (41%) enrolled in the study. The mean age of enrollees was 56.3 ± 12.6 years (range, 19 to 89 years), 52% were male, and 94% were white. Survivors less likely to enroll included those who were male, age <40 years, and who received an autologous transplant (all P < .001). Compared with white survivors, African Americans were less likely to enroll (P < .001), whereas Native Americans/Alaska Natives were more likely to join the study (P = .03). The reach of the INSPIRE program was broad, including to survivors who traditionally have less access to resources, such as Native Americans/Alaskan Natives and rural residents. Strategies are still needed to improve the enrollment of online studies of survivorship resources for males, young adults, African American, and autologous HCT survivors because their use may improve outcomes.",2020,"Compared with survivors of white race, African Americans were less likely to enroll (P<.001) while Native Americans/Alaska Natives were more likely to join the study (P=.03).
","['eligible survivors who were more or less likely to enroll', 'Survivors less likely to enroll included those who were male, age younger than 40, and who received an autologous transplant (all P<.001', 'hematopoietic cell transplantation survivors', 'Native Americans/Alaskan Natives and rural residents', 'hematopoietic cell transplantation (HCT) cancer survivors', 'Eligible participants had access to the internet, an email address, and did not have active disease in the past two years', '2578 eligible HCT survivors, 1065 (41%) enrolled in the study', 'Mean age of enrollees was 56.3 (SD=12.6; age range 19 to 89 years), 52% were male, and 94% were White']",['HCT'],[],"[{'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0040736', 'cui_str': 'Autogenous transplantation'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C0282204', 'cui_str': 'Native Americans'}, {'cui': 'C0682125', 'cui_str': 'Native Alaskians'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0376649', 'cui_str': 'Addresses'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}]","[{'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}]",[],2578.0,0.117693,"Compared with survivors of white race, African Americans were less likely to enroll (P<.001) while Native Americans/Alaska Natives were more likely to join the study (P=.03).
","[{'ForeName': 'Jean C', 'Initials': 'JC', 'LastName': 'Yi', 'Affiliation': 'Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington. Electronic address: jyi@fredhutch.org.'}, {'ForeName': 'Brie', 'Initials': 'B', 'LastName': 'Sullivan', 'Affiliation': 'Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Wendy M', 'Initials': 'WM', 'LastName': 'Leisenring', 'Affiliation': 'Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Navneet S', 'Initials': 'NS', 'LastName': 'Majhail', 'Affiliation': 'Cleveland Clinic, Blood and Marrow Transplant Program, Cleveland, Ohio.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Jim', 'Affiliation': 'Moffitt Cancer Center, Tampa, Florida.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Loren', 'Affiliation': 'University of Pennsylvania, Blood & Marrow Transplant, Cell Therapy & Transplant Program, Philadelphia, Pennsylvania.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Uberti', 'Affiliation': 'Barbara Ann Karmanos Cancer Institute, Detroit, Michigan.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Whalen', 'Affiliation': 'University of Nebraska, Blood & Marrow Stem Cell Transplant Program, Omaha, Nebraska.'}, {'ForeName': 'Mary E D', 'Initials': 'MED', 'LastName': 'Flowers', 'Affiliation': 'Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington; University of Washington School of Medicine, Seattle, Washington.'}, {'ForeName': 'Stephanie J', 'Initials': 'SJ', 'LastName': 'Lee', 'Affiliation': 'Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington; University of Washington School of Medicine, Seattle, Washington.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Maynard', 'Affiliation': 'Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Syrjala', 'Affiliation': 'Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington; University of Washington School of Medicine, Seattle, Washington.'}]",Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation,['10.1016/j.bbmt.2020.06.017']
1239,32607644,Subclinical affective and cognitive fluctuations in Parkinson's disease: a randomized double-blind double-dummy study of Oral vs. Intrajejunal Levodopa.,"BACKGROUND


Chronic levodopa treatment in Parkinson's disease (PD) may promote undesirable motor and non-motor fluctuations. Compared to chronic oral levodopa treatment, continuous infusion of levodopa/carbidopa intestinal gel (LCIG) in advanced PD reduces motor fluctuations. However, differences in their effect on acute non-motor changes were not formally demonstrated.
OBJECTIVE


We performed a randomized, double-blind, double-dummy, crossover study to compare acute non-motor changes between intermittent oral immediate-release carbidopa/levodopa (LC-IR) and LCIG.
METHODS


After > 12-h OFF, thirteen PD patients chronically treated with LCIG and without history of non-motor swings, were allocated to receive first, LCIG infusion plus three oral doses of placebo, or placebo infusion plus three oral doses of LC-IR. Over-encapsulated oral medication (LC-IR or placebo) was administered every 2 h. We monitored plasmatic levels of levodopa, motor status (UPDRS-III), mood, anxiety, and frontal functions at baseline (0-h) and hourly after each oral challenge.
RESULTS


Repeated-measures ANOVAs showed significant group by treatment interaction indicating more fluctuations of levodopa plasma levels with LC-IR. No significant interactions were seen in the temporal profile of motor status, anxiety, mood and cognition. However, point-to-point parametric and nonparametric tests showed a significant more marked and more sustained improvement in anxiety scores under LCIG. A significant improvement of mood and verbal fluency was seen a + 3-h only under LCIG.
DISCUSSION


Our sample of advanced PD patients exhibited moderate but significant non-motor fluctuations. LCIG was associated with a more favorable profile of acute affective and cognitive fluctuations that was particularly expressed at the first part of the infusion curve.",2020,"However, point-to-point parametric and nonparametric tests showed a significant more marked and more sustained improvement in anxiety scores under LCIG.","[""Parkinson's disease"", 'thirteen PD patients chronically treated with LCIG and without history of non-motor swings', ""Parkinson's disease (PD""]","['levodopa/carbidopa intestinal gel (LCIG', 'encapsulated oral medication (LC-IR or placebo', 'LCIG', 'intermittent oral immediate-release carbidopa/levodopa\xa0(LC-IR) and LCIG', 'LCIG infusion plus three oral doses of placebo, or placebo infusion plus three oral doses of LC-IR', 'Oral vs. Intrajejunal Levodopa']","['temporal profile of motor status, anxiety, mood and cognition', 'plasmatic levels of levodopa, motor status (UPDRS-III), mood, anxiety, and frontal functions at baseline (0-h) and hourly after each oral challenge', 'acute affective and cognitive fluctuations', 'mood and verbal fluency', 'anxiety scores', 'Subclinical affective and cognitive fluctuations', 'fluctuations of levodopa plasma levels']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0006982', 'cui_str': 'Carbidopa'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0262926', 'cui_str': 'History of'}]","[{'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0006982', 'cui_str': 'Carbidopa'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0205223', 'cui_str': 'Encapsulated'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0353697', 'cui_str': 'Carbidopa- and levodopa-containing product'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0442043', 'cui_str': 'Temporal'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0558292', 'cui_str': 'Hourly'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0231239', 'cui_str': 'Fluctuation'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205211', 'cui_str': 'Subclinical'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}]",,0.283193,"However, point-to-point parametric and nonparametric tests showed a significant more marked and more sustained improvement in anxiety scores under LCIG.","[{'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Kulisevsky', 'Affiliation': 'Movement Disorders Unit, Neurology Department, Hospital de la Santa Creu i Sant Pau, Mas Casanovas 90, 08041, Barcelona, Spain. jkulisevsky@santpau.cat.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Bejr-Kasem', 'Affiliation': 'Movement Disorders Unit, Neurology Department, Hospital de la Santa Creu i Sant Pau, Mas Casanovas 90, 08041, Barcelona, Spain.'}, {'ForeName': 'Saul', 'Initials': 'S', 'LastName': 'Martinez-Horta', 'Affiliation': 'Movement Disorders Unit, Neurology Department, Hospital de la Santa Creu i Sant Pau, Mas Casanovas 90, 08041, Barcelona, Spain.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Horta-Barba', 'Affiliation': 'Movement Disorders Unit, Neurology Department, Hospital de la Santa Creu i Sant Pau, Mas Casanovas 90, 08041, Barcelona, Spain.'}, {'ForeName': 'Berta', 'Initials': 'B', 'LastName': 'Pascual-Sedano', 'Affiliation': 'Movement Disorders Unit, Neurology Department, Hospital de la Santa Creu i Sant Pau, Mas Casanovas 90, 08041, Barcelona, Spain.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Campolongo', 'Affiliation': 'Movement Disorders Unit, Neurology Department, Hospital de la Santa Creu i Sant Pau, Mas Casanovas 90, 08041, Barcelona, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Marín-Lahoz', 'Affiliation': 'Movement Disorders Unit, Neurology Department, Hospital de la Santa Creu i Sant Pau, Mas Casanovas 90, 08041, Barcelona, Spain.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Aracil-Bolaños', 'Affiliation': 'Movement Disorders Unit, Neurology Department, Hospital de la Santa Creu i Sant Pau, Mas Casanovas 90, 08041, Barcelona, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Pérez-Pérez', 'Affiliation': 'Movement Disorders Unit, Neurology Department, Hospital de la Santa Creu i Sant Pau, Mas Casanovas 90, 08041, Barcelona, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Izquierdo-Barrionuevo', 'Affiliation': 'Movement Disorders Unit, Neurology Department, Hospital de la Santa Creu i Sant Pau, Mas Casanovas 90, 08041, Barcelona, Spain.'}, {'ForeName': 'Oriol', 'Initials': 'O', 'LastName': 'de Fàbregues', 'Affiliation': ""Movement Disorders Unit, Neurology Department, Vall d'Hebron University Hospital, Neurodegenerative Diseases Research Group-Vall d'Hebron Research Institute, UAB, Barcelona, Spain.""}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Puente', 'Affiliation': ""Neurology Department, Institut Municipal d'Investigacio Medica, UAB, Hospital del Mar, Barcelona, Spain.""}, {'ForeName': 'Ane', 'Initials': 'A', 'LastName': 'Crespo-Cuevas', 'Affiliation': 'Department of Neurosciences, Hospital Universitari Germans Trias i Pujol, UAB, Badalona, Barcelona, Spain.'}, {'ForeName': 'Matilde', 'Initials': 'M', 'LastName': 'Calopa', 'Affiliation': 'Neurology Service, Hospital Universitari de Bellvitge, Barcelona, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Pagonabarraga', 'Affiliation': 'Movement Disorders Unit, Neurology Department, Hospital de la Santa Creu i Sant Pau, Mas Casanovas 90, 08041, Barcelona, Spain.'}]",Journal of neurology,['10.1007/s00415-020-10018-y']
1240,32628266,Characteristics of Recurrent Ischemic Stroke After Embolic Stroke of Undetermined Source: Secondary Analysis of a Randomized Clinical Trial.,"Importance


The concept of embolic stroke of undetermined source (ESUS) unifies a subgroup of cryptogenic strokes based on neuroimaging, a defined minimum set of diagnostic tests, and exclusion of certain causes. Despite an annual stroke recurrence rate of 5%, little is known about the etiology underlying recurrent stroke after ESUS.
Objective


To identify the stroke subtype of recurrent ischemic strokes after ESUS, to explore the interaction with treatment assignment in each category, and to examine the consistency of cerebral location of qualifying ESUS and recurrent ischemic stroke.
Design, Setting, and Participants


The NAVIGATE-ESUS trial was a randomized clinical trial conducted from December 23, 2014, to October 5, 2017. The trial compared the efficacy and safety of rivaroxaban and aspirin in patients with recent ESUS (n = 7213). Ischemic stroke was validated in 309 of the 7213 patients by adjudicators blinded to treatment assignment and classified by local investigators into the categories ESUS or non-ESUS (ie, cardioembolic, atherosclerotic, lacunar, other determined cause, or insufficient testing). Five patients with recurrent strokes that could not be defined as ischemic or hemorrhagic in absence of neuroimaging or autopsy were excluded. Data for this secondary post hoc analysis were analyzed from March to June 2019.
Interventions


Patients were randomly assigned to receive rivaroxaban, 15 mg/d, or aspirin, 100 mg/d.
Main Outcomes and Measures


Association of recurrent ESUS with stroke characteristics.
Results


A total of 309 patients (205 men [66%]; mean [SD] age, 68 [10] years) had ischemic stroke identified during the median follow-up of 11 (interquartile range [IQR], 12) months (annualized rate, 4.6%). Diagnostic testing was insufficient for etiological classification in 39 patients (13%). Of 270 classifiable ischemic strokes, 156 (58%) were ESUS and 114 (42%) were non-ESUS (37 [32%] cardioembolic, 26 [23%] atherosclerotic, 35 [31%] lacunar, and 16 [14%] other determined cause). Atrial fibrillation was found in 27 patients (9%) with recurrent ischemic stroke and was associated with higher morbidity (median change in modified Rankin scale score 2 [IQR, 3] vs 0 (IQR, 1]) and mortality (15% vs 1%) than other causes. Risk of recurrence did not differ significantly by subtype between treatment groups. For both the qualifying and recurrent strokes, location of infarct was more often in the left (46% and 54%, respectively) than right hemisphere (40% and 37%, respectively) or brainstem or cerebellum (14% and 9%, respectively).
Conclusions and Relevance


In this secondary analysis of randomized clinical trial data, most recurrent strokes after ESUS were embolic and of undetermined source. Recurrences associated with atrial fibrillation were a minority but were more often disabling and fatal. More extensive investigation to identify the embolic source is important toward an effective antithrombotic strategy.
Trial Registration


ClinicalTrials.gov Identifier: NCT02313909.",2020,Risk of recurrence did not differ significantly by subtype between treatment groups.,"['309 patients (205 men [66%]; mean [SD] age, 68 [10] years) had ischemic stroke identified during the median follow-up of 11 (interquartile range [IQR], 12) months (annualized rate, 4.6', 'patients with recent ESUS (n\u2009=\u20097213', '309 of the 7213 patients by adjudicators blinded to treatment assignment and classified by local investigators into the categories ESUS or non-ESUS (ie, cardioembolic, atherosclerotic, lacunar, other determined cause, or insufficient testing', '39 patients (13', 'After Embolic Stroke of Undetermined Source', 'Five patients with recurrent strokes']","['rivaroxaban', 'rivaroxaban and aspirin', 'aspirin']","['Risk of recurrence', 'Recurrences associated with atrial fibrillation', 'Atrial fibrillation', 'efficacy and safety', 'recurrent ischemic stroke', 'mortality', 'Recurrent Ischemic Stroke', 'higher morbidity', 'Ischemic stroke']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4517764', 'cui_str': '4.6'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C3888970', 'cui_str': 'Embolic stroke of undetermined source'}, {'cui': 'C0401783', 'cui_str': 'Adjudicator'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C1836785', 'cui_str': 'Recurrent stroke'}]","[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",5.0,0.199184,Risk of recurrence did not differ significantly by subtype between treatment groups.,"[{'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Veltkamp', 'Affiliation': 'Division of Brain Sciences, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Lesly A', 'Initials': 'LA', 'LastName': 'Pearce', 'Affiliation': 'currently a biostatistics consultant, St Catharines, Ontario, Canada.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Korompoki', 'Affiliation': 'Division of Brain Sciences, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Mukul', 'Initials': 'M', 'LastName': 'Sharma', 'Affiliation': 'Population Health Research Institute, Department of Medicine, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Scott E', 'Initials': 'SE', 'LastName': 'Kasner', 'Affiliation': 'Department of Neurology, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Danilo S', 'Initials': 'DS', 'LastName': 'Toni', 'Affiliation': 'Department of Human Neurosciences, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Sebastian F', 'Initials': 'SF', 'LastName': 'Ameriso', 'Affiliation': 'Departamento de Neurología, Fleni, Buenos Aires, Argentina.'}, {'ForeName': 'Hardi', 'Initials': 'H', 'LastName': 'Mundl', 'Affiliation': 'Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Turgut', 'Initials': 'T', 'LastName': 'Tatlisumak', 'Affiliation': 'Department of Clinical Neuroscience, Institute of Neurosciences and Physiology, Sahlgrenska Academy at University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Graeme J', 'Initials': 'GJ', 'LastName': 'Hankey', 'Affiliation': 'Faculty of Health and Medical Sciences, Medical School, University of Western Australia, Perth, Australia.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Lindgren', 'Affiliation': 'Department of Clinical Sciences and Neurology, Lund University, Lund, Sweden.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Berkowitz', 'Affiliation': 'Bayer, LLC, Whippany, New Jersey.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Arauz', 'Affiliation': 'Instituto Nacional de Neurologia y Neurocirugia Manual Velasco Suarez, Mexico City, Mexico.'}, {'ForeName': 'Serefnur', 'Initials': 'S', 'LastName': 'Ozturk', 'Affiliation': 'Department of Neurology, Faculty of Medicine, Selcuk University, Konya, Turkey.'}, {'ForeName': 'Keith W', 'Initials': 'KW', 'LastName': 'Muir', 'Affiliation': 'Institute of Neuroscience and Psychology, University of Glasgow, Queen Elizabeth University Hospital, Glasgow, United Kingdom.'}, {'ForeName': 'Ángel', 'Initials': 'Á', 'LastName': 'Chamorro', 'Affiliation': 'Department of Neuroscience, Hospital Clinic of Barcelona, Institute Reçerca Biomèdica August Pi i Sunyer, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Kanjana', 'Initials': 'K', 'LastName': 'Perera', 'Affiliation': 'Population Health Research Institute, Department of Medicine, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Ashfaq', 'Initials': 'A', 'LastName': 'Shuaib', 'Affiliation': 'Department of Medicine, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Rudilosso', 'Affiliation': 'Department of Neuroscience, Hospital Clinic of Barcelona, Institute Reçerca Biomèdica August Pi i Sunyer, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Ashkan', 'Initials': 'A', 'LastName': 'Shoamanesh', 'Affiliation': 'Population Health Research Institute, Department of Medicine, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Stuart J', 'Initials': 'SJ', 'LastName': 'Connolly', 'Affiliation': 'Population Health Research Institute, Department of Medicine, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Hart', 'Affiliation': 'Population Health Research Institute, Department of Medicine, McMaster University, Hamilton, Ontario, Canada.'}]",JAMA neurology,['10.1001/jamaneurol.2020.1995']
1241,32624575,Vitamin D supplementation: a potential therapeutic agent for metastatic colorectal cancer.,"Preclinical and epidemiological evidence suggests that vitamin D may have anti-cancer activities in patients with colorectal cancer. A recently completed, randomised Phase 2 trial of vitamin D 3  supplementation in patients with metastatic colorectal cancer has shown promising results, and a Phase 3 trial is currently underway.",2020,"A recently completed, randomised Phase 2 trial of vitamin D 3  supplementation in patients with metastatic colorectal cancer has shown promising results, and a Phase 3 trial is currently underway.","['patients with colorectal cancer', 'metastatic colorectal cancer', 'patients with metastatic colorectal cancer']","['vitamin D 3  supplementation', 'vitamin D', 'Vitamin D supplementation']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}]",[],3.0,0.117711,"A recently completed, randomised Phase 2 trial of vitamin D 3  supplementation in patients with metastatic colorectal cancer has shown promising results, and a Phase 3 trial is currently underway.","[{'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Yuan', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Kimmie', 'Initials': 'K', 'LastName': 'Ng', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA, USA. kimme_ng@dfci.harvard.edu.'}]",British journal of cancer,['10.1038/s41416-020-0958-8']
1242,32629403,Monomethyl fumarate has better gastrointestinal tolerability profile compared with dimethyl fumarate.,"BACKGROUND


Monomethyl fumarate (MMF) is the pharmacologically active metabolite of dimethyl fumarate (DMF). MMF formulated as Bafiertam™ 190 mg and DMF formulated as Tecfidera 240 mg deliver bioequivalent exposure of MMF and therefore possess the same efficacy/safety profiles. DMF is a widely used oral treatment for relapsing-remitting forms of multiple sclerosis (RRMS) but is limited in some patients, primarily female, by issues with gastrointestinal (GI) tolerability.
METHODS


This was a randomized, double-blind, head-to-head, 5-week study evaluating the GI tolerability of MMF 190 mg vs DMF 240 mg, administered twice daily in healthy subjects, using a derivative of the self-administered Modified Overall Gastrointestinal Symptom Scale (MOGISS). Subjects were stratified (3:1, female:male) and randomized (1:1) to the treatments. The primary endpoint was the Area Under the Curve (AUC) in each of the individual symptoms in the MOGISS over the 5-week treatment period. Other endpoints included the AUC over the 5-week treatment period in the MOGISS composite and total scores; duration and severity of GI events; Number and percentage of subjects reporting GI events during the overall treatment period, and assessment of safety/tolerability.
RESULTS


Inferential analysis of the hierarchical testing of overall treatment differences in each MOGISS symptom AUC occurred in a predefined sequence starting with Abdominal Pain. For each symptom, LSMean AUC values were lower for MMF than DMF, however, the first primary endpoint, Abdominal Pain, was not statistically different between treatments; thus, all subsequent statistical analyses were considered exploratory. The side effects and safety profiles observed were consistent with the known profiles of DMF, with no new or unique safety concerns noted.
CONCLUSIONS


Bafiertam showed an improved gastrointestinal tolerability profile compared with Tecfidera, with less severe GI events and fewer days of self-assessed GI symptoms, fewer GI adverse events, and lower discontinuation rates because of GI adverse events.",2020,"The side effects and safety profiles observed were consistent with the known profiles of DMF, with no new or unique safety concerns noted.
",['healthy subjects'],"['DMF', 'Monomethyl fumarate (MMF', 'MMF 190 mg vs DMF']","['LSMean AUC values', 'MOGISS composite and total scores; duration and severity of GI events; Number and percentage of subjects reporting GI events', 'gastrointestinal tolerability profile', 'derivative of the self-administered Modified Overall Gastrointestinal Symptom Scale (MOGISS', 'Area Under the Curve (AUC', 'safety/tolerability', 'Abdominal Pain', 'GI tolerability', 'severe GI events and fewer days of self-assessed GI symptoms, fewer GI adverse events']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0058218', 'cui_str': 'dimethyl fumarate'}, {'cui': 'C3848524', 'cui_str': 'monomethyl fumarate'}, {'cui': 'C0083765', 'cui_str': 'NMF protocol'}, {'cui': 'C4517622', 'cui_str': '190'}]","[{'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0243072', 'cui_str': 'derivatives'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205388', 'cui_str': 'Few'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0797155,"The side effects and safety profiles observed were consistent with the known profiles of DMF, with no new or unique safety concerns noted.
","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Wynn', 'Affiliation': 'Consultants in Neurology, Ltd, Northbrook, IL 60062, USA.'}, {'ForeName': 'Thomas W', 'Initials': 'TW', 'LastName': 'Lategan', 'Affiliation': 'Banner Life Sciences, 3890 Premier Dr., Suite 110, High Point, NC 27265, USA. Electronic address: Lategan@bannerls.com.'}, {'ForeName': 'Tiffany N', 'Initials': 'TN', 'LastName': 'Sprague', 'Affiliation': 'Banner Life Sciences, 3890 Premier Dr., Suite 110, High Point, NC 27265, USA.'}, {'ForeName': 'Franck S', 'Initials': 'FS', 'LastName': 'Rousseau', 'Affiliation': 'Banner Life Sciences, 3890 Premier Dr., Suite 110, High Point, NC 27265, USA.'}, {'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': 'Fox', 'Affiliation': 'Central Texas Neurology Consultants, Round Rock, TX 78681, USA.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2020.102335']
1243,32611217,Public Perceptions of Artificial Intelligence and Robotics in Medicine.,"Objective:  To understand better the public perception and comprehension of medical technology such as artificial intelligence (AI) and robotic surgery. In addition to this, to identify sensitivity to their use to ensure acceptability and quality of counseling.  Subjects and Methods:  A survey was conducted on a convenience sample of visitors to the MN Minnesota State Fair ( n  = 264). Participants were randomized to receive one of two similar surveys. In the first, a diagnosis was made by a physician and in the second by an AI application to compare confidence in human and computer-based diagnosis.  Results:  The median age of participants was 45 (interquartile range 28-59), 58% were female ( n  = 154)  vs  42% male ( n  = 110), 69% had completed at least a bachelor's degree, 88% were Caucasian ( n  = 233)  vs  12% ethnic minorities ( n  = 31) and were from 12 states, mostly from the Upper Midwest. Participants had nearly equal trust in AI  vs  physician diagnoses. However, they were significantly more likely to trust an AI diagnosis of cancer over a doctor's diagnosis when responding to the version of the survey that suggested that an AI could make medical diagnoses ( p  = 9.32e-06). Though 55% of respondents ( n  = 145) reported that they were uncomfortable with automated robotic surgery, the majority of the individuals surveyed (88%) mistakenly believed that partially autonomous surgery was already happening. Almost all (94%,  n  = 249) stated that they would be willing to pay for a review of medical imaging by an AI if available.  Conclusion:  Most participants express confidence in AI providing medical diagnoses, sometimes even over human physicians. Participants generally express concern with surgical AI, but they mistakenly believe that it is already being performed. As AI applications increase in medical practice, health care providers should be cognizant of the potential amount of misinformation and sensitivity that patients have to how such technology is represented.",2020,"Almost all (94%, n=249) stated they would be willing to pay for a review of medical imaging by an AI if available.
","[""The median age of participants was 45 (IQR 28-59), 58% were female (n=154) vs. 42% male (n=110), 69% had completed at least a bachelor's degree, 88% were Caucasian (n=233) vs. 12% ethnic minorities (n=31) and were from 12 states, most from the Upper Midwest"", 'convenience sample of visitors to the MN Minnesota State Fair (n= 264']",[],['acceptability and quality of counseling'],"[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0337600', 'cui_str': 'Bachelor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0026183', 'cui_str': 'Minnesota'}, {'cui': 'C2911689', 'cui_str': 'Fair'}]",[],"[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]",88.0,0.0315296,"Almost all (94%, n=249) stated they would be willing to pay for a review of medical imaging by an AI if available.
","[{'ForeName': 'Bethany', 'Initials': 'B', 'LastName': 'Stai', 'Affiliation': 'Department of Computer Science and Engineering, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Heller', 'Affiliation': 'Department of Computer Science and Engineering, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'McSweeney', 'Affiliation': 'Department of Urology, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Rickman', 'Affiliation': 'Department of Computer Science and Engineering, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Blake', 'Affiliation': 'Department of Urology, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Ranveer', 'Initials': 'R', 'LastName': 'Vasdev', 'Affiliation': 'Department of Urology, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Zach', 'Initials': 'Z', 'LastName': 'Edgerton', 'Affiliation': 'Department of Urology, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Resha', 'Initials': 'R', 'LastName': 'Tejpaul', 'Affiliation': 'Department of Computer Science and Engineering, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Matt', 'Initials': 'M', 'LastName': 'Peterson', 'Affiliation': 'Department of Urology, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Rosenberg', 'Affiliation': 'Department of Urology, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Arveen', 'Initials': 'A', 'LastName': 'Kalapara', 'Affiliation': 'Department of Urology, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Subodh', 'Initials': 'S', 'LastName': 'Regmi', 'Affiliation': 'Department of Urology, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Papanikolopoulos', 'Affiliation': 'Department of Computer Science and Engineering, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Weight', 'Affiliation': 'Department of Urology, University of Minnesota, Minneapolis, Minnesota, USA.'}]",Journal of endourology,['10.1089/end.2020.0137']
1244,32616595,SABRTOOTH: A randomised controlled feasibility study of Stereotactic Ablative Radiotherapy (SABR) with surgery in paTients with peripheral stage I nOn-small cell lung cancer (NSCLC) cOnsidered To be at Higher risk of complications from surgical resection.,"OBJECTIVES


Stereotactic Ablative Radiotherapy (SABR) is a well-established treatment for medically inoperable peripheral stage I non-small cell lung cancer (NSCLC). Previous non-randomised evidence supports SABR as an alternative to surgery, but high quality randomised controlled trial (RCT) evidence is lacking. The SABRTooth study aimed to establish whether a UK phase III RCT was feasible.
DESIGN AND METHODS


SABRTooth was a UK multi-centre, randomised controlled feasibility study targeting patients with peripheral stage I NSCLC considered to be at higher-risk of surgical complications. Fifty-four patients were planned to be randomised 1:1 to SABR or surgery. The primary outcome was monthly average recruitment rates.
RESULTS


Between July 2015 and January 2017, 318 patients were considered for the study and 205(64.5%) were deemed ineligible. Of 106 assessed as eligible (33.3%), 24 patients (22.6%) were randomised to SABR (n=14) or surgery (n=10). A key theme for non-participation was treatment preference with 43 (41%) preferring non-surgical treatment and 19(18%) preferring surgery. The average monthly recruitment rate was 1.7 patients against a target of 3. Fifteen patients underwent their allocated treatment, 12 SABR, 3 surgery.
CONCLUSIONS


We conclude that a phase III RCT randomising higher-risk patients between SABR and surgery is not feasible in the National Health Service (NHS). Patients have pre-existing treatment preferences, which was a barrier to recruitment. A significant proportion of patients randomised to the surgical group declined and chose SABR. SABR remains an alternative to surgery and novel study approaches are needed to define which patients benefit from a non-surgical approach.",2020,A key theme for non-participation was treatment preference with 43 (41%) preferring non-surgical treatment and 19(18%) preferring surgery.,"['medically inoperable peripheral stage I non-small cell lung cancer (NSCLC', 'Of 106 assessed as eligible (33.3%), 24 patients (22.6%) were randomised to SABR (n=14) or surgery (n=10', 'patients with peripheral stage I NSCLC considered to be at higher-risk of surgical complications', 'SABRTooth was a UK multi-centre', 'Between July 2015 and January 2017, 318 patients were considered for the study and 205(64.5%) were deemed ineligible', 'paTients with peripheral stage I nOn-small cell lung cancer (NSCLC', 'Fifteen patients underwent their allocated treatment, 12 SABR, 3 surgery']",['Stereotactic Ablative Radiotherapy (SABR'],['monthly average recruitment rates'],"[{'cui': 'C0205187', 'cui_str': 'Inoperable'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0278504', 'cui_str': 'Non-small cell lung cancer stage I'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C4517716', 'cui_str': '33.3'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0729296', 'cui_str': 'Stereotactic'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0729296', 'cui_str': 'Stereotactic'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}]",318.0,0.306544,A key theme for non-participation was treatment preference with 43 (41%) preferring non-surgical treatment and 19(18%) preferring surgery.,"[{'ForeName': 'Kevin N', 'Initials': 'KN', 'LastName': 'Franks', 'Affiliation': ""Leeds Cancer Centre, St James's University Hospital, Leeds, United Kingdom kevin.franks@nhs.net.""}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'McParland', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Webster', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Baldwin', 'Affiliation': 'Nottingham University Hospitals, Nottingham, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Sebag-Montefiore', 'Affiliation': ""Leeds Cancer Centre, St James's University Hospital, Leeds, United Kingdom.""}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Evison', 'Affiliation': 'Manchester University Hospitals NHS Foundation Trust & University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Booton', 'Affiliation': 'Manchester University Hospitals NHS Foundation Trust & University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Faivre-Finn', 'Affiliation': 'University of Manchester and The Christie NHS Foundation Trust, Manchester, United Kingdom.'}, {'ForeName': 'Babu', 'Initials': 'B', 'LastName': 'Naidu', 'Affiliation': 'Institute of Inflammation and Ageing, College of Medical and Dental Sciences, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Ferguson', 'Affiliation': 'The James Cook University Hospital, Middlesbrough, United Kingdom.'}, {'ForeName': 'Clive', 'Initials': 'C', 'LastName': 'Peedell', 'Affiliation': 'The James Cook University Hospital, Middlesbrough, United Kingdom.'}, {'ForeName': 'Matthew E J', 'Initials': 'MEJ', 'LastName': 'Callister', 'Affiliation': 'Department of Respiratory Medicine, Leeds Teaching Hospitals, Leeds, United Kingdom.'}, {'ForeName': 'Martyn', 'Initials': 'M', 'LastName': 'Kennedy', 'Affiliation': 'Department of Respiratory Medicine, Leeds Teaching Hospitals, Leeds, United Kingdom.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Hewison', 'Affiliation': 'Leeds Institute of Health Sciences, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Janine', 'Initials': 'J', 'LastName': 'Bestall', 'Affiliation': 'Leeds Institute of Health Sciences, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Walter M', 'Initials': 'WM', 'LastName': 'Gregory', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hall', 'Affiliation': 'Western General Hospital, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Collinson', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Olivier', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Naylor', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Bell', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Allen', 'Affiliation': 'Patient and Public Involvement Representative, Leeds, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Sloss', 'Affiliation': 'Patient and Public Involvement Representative, Leeds, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Snee', 'Affiliation': ""Leeds Cancer Centre, St James's University Hospital, Leeds, United Kingdom.""}]",The European respiratory journal,['10.1183/13993003.00118-2020']
1245,32618258,Impact of Different Strategies for Delivering Supplemental Zinc on Selected Fecal Markers of Environmental Enteric Dysfunction among Young Laotian Children: A Randomized Controlled Trial.,"The objective of this study was to assess the impact of different strategies for delivering supplemental zinc on fecal myeloperoxidase (MPO), neopterin (NEO), and calprotectin (CAL) among young Laotian children. In a double-blind controlled trial, children aged 6-23 months were randomized to receive either daily preventive zinc (PZ) tablets (7 mg/day), daily micronutrient powder (MNP; containing 10 mg zinc and 14 other micronutrients), therapeutic zinc (TZ) supplements for diarrhea treatment (20 mg/day for 10 days), or daily placebo powder and followed for ∼36 weeks. Stool samples were collected at baseline and endline. Fecal MPO, NEO, and CAL concentrations were determined in a randomly selected subsample of 720 children using commercially available ELISA kits. At baseline, the mean age was 14.1 ± 4.9 months and prevalence of stunting was 39%. The endline prevalence of stunting was 43%; there was no overall treatment effect on physical growth in the parent trial. At endline, the mean (95% CI) MPO in the PZ group was 1,590 [1,396; 1,811] ng/mL and did not differ from that in the MNP (1,633 [1,434; 1,859] ng/mL), TZ (1,749 [1,535; 1,992] ng/mL), and control (1,612 [1,415; 1,836] ng/mL) groups ( P  = 0.749). Similarly, there was no overall treatment effect on NEO and CAL concentrations ( P  = 0.226 and 0.229, respectively). In this population, the provision of PZ or TZ supplements or MNP had no impact on growth or environmental enteric dysfunction (EED) as assessed by fecal MPO, NEO, and CAL. Additional research is needed to better understand the etiology and proposed mechanisms of EED pathogenesis.",2020,"Similarly, there was no overall treatment effect on NEO and CAL concentrations ( P  = 0.226 and 0.229, respectively).","['young Laotian children', 'Young Laotian Children', 'children aged 6-23 months']","['daily micronutrient powder (MNP; containing 10 mg zinc and 14 other micronutrients), therapeutic zinc (TZ) supplements for diarrhea treatment', 'placebo powder', 'daily preventive zinc (PZ) tablets', 'TZ', 'PZ or TZ supplements or MNP', 'MNP']","['prevalence of stunting', 'fecal myeloperoxidase (MPO), neopterin (NEO), and calprotectin (CAL', 'physical growth', 'Fecal MPO, NEO, and CAL concentrations', 'growth or environmental enteric dysfunction (EED', 'NEO and CAL concentrations']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0023033', 'cui_str': 'Lao language'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0040577', 'cui_str': 'Trace element'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C3541396', 'cui_str': 'Zinc'}]","[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0018273', 'cui_str': 'Growth disorder'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0027021', 'cui_str': 'Peroxidase'}, {'cui': 'C0068527', 'cui_str': 'Neopterin'}, {'cui': 'C0950624', 'cui_str': 'Calprotectin'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C1304890', 'cui_str': 'Enteral'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}]",720.0,0.568268,"Similarly, there was no overall treatment effect on NEO and CAL concentrations ( P  = 0.226 and 0.229, respectively).","[{'ForeName': 'Guy-Marino', 'Initials': 'GM', 'LastName': 'Hinnouho', 'Affiliation': 'Helen Keller International, Washington, District of Columbia.'}, {'ForeName': 'K Ryan', 'Initials': 'KR', 'LastName': 'Wessells', 'Affiliation': 'Department of Nutrition, Institute for Global Nutrition, University of California, Davis, Davis, California.'}, {'ForeName': 'Maxwell A', 'Initials': 'MA', 'LastName': 'Barffour', 'Affiliation': 'Public Health Program, College of Health and Human Services, Missouri State University, Springfield, Missouri.'}, {'ForeName': 'Somphou', 'Initials': 'S', 'LastName': 'Sayasone', 'Affiliation': ""Lao Tropical and Public Health Institute, Vientiane, Lao People's Democratic Republic.""}, {'ForeName': 'Charles D', 'Initials': 'CD', 'LastName': 'Arnold', 'Affiliation': 'Department of Nutrition, Institute for Global Nutrition, University of California, Davis, Davis, California.'}, {'ForeName': 'Sengchanh', 'Initials': 'S', 'LastName': 'Kounnavong', 'Affiliation': ""Lao Tropical and Public Health Institute, Vientiane, Lao People's Democratic Republic.""}, {'ForeName': 'Sonja Y', 'Initials': 'SY', 'LastName': 'Hess', 'Affiliation': 'Department of Nutrition, Institute for Global Nutrition, University of California, Davis, Davis, California.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.20-0106']
1246,32621900,Comparison of Toric Implantable Collamer Lens and Toric Artiflex Phakic IOLs in Terms of Visual Outcome: a Paired Contralateral Eye Study.,"PURPOSE


This study sought to compare the postoperative visual outcomes of toric implantable collamer lens (T-ICL) with toric Artiflex (T-Artiflex) lenses.
DESIGN


Alternating treatment, contralateral eye matched clinical study.
METHODS


This study compared 82 eyes of 41 patients with T-ICL lenses in one eye and toric Artiflex implantation in the contralateral eye to correct myopic astigmatism. Safety, efficacy, predictability, astigmatic vector changes, contrast sensitivity, endothelial cell count, and possible adverse events were assessed at least 12 months postoperatively.
RESULTS


After a mean follow-up of 12 months, the safety index was mean 1.40 ± 0.70 in the T-ICL group and 1.20 ± 0.21 in the T-Artiflex group. Furthermore, their mean efficacy indexes were 1.24 ± 0.42 and 1.08 ± 0.23, respectively (P = .029). A total of 39 eyes (95%) in the T-ICL group and 41 eyes (100%) in the T-Artiflex group were within ±1.00 diopter (D) of emmetropia and 33 eyes (80%) and 34 eyes (83%) were within ±0.5 D of emmetropia, respectively. Vector analysis revealed mean index of success as large as 0.25 ± 0.22 in the T-ICL group and 0.24 ± 0.15 in the T-Artiflex group. Postoperative contrast sensitivities were equal in both groups under mesopic conditions for any given spatial frequency. There was an endothelial loss of 2.18% and 1.95% in the T-ICL and T-Artiflex groups, respectively. There were no significant complications in any of the groups.
CONCLUSIONS


Both lenses showed promising results in terms of safety, efficacy, and predictability for correction of myopic astigmatism. As shown in this paired-eye study, most outcomes were almost identical, and neither of these lenses were clinically superior to the other.",2020,"There was no significant complication in any of the groups.
",['82 eyes of 41 patients with toric ICL implantation in one eye and toric Artiflex implantation in the contralateral eye to correct myopic astigmatism'],"['Toric Implantable Collamer Lens and Toric Artiflex Phakic IOLs', 'toric implantable collamer lens (T-ICL) and toric Artiflex (T-Artiflex) implantation']","['mean efficacy index', 'safety index', 'endothelial cell loss', 'Safety, efficacy, predictability, astigmatic vector changes, contrast sensitivity, endothelial cell count, and possible adverse events', 'mean index of success', 'safety, efficacy, and predictability']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0441988', 'cui_str': 'Contralateral'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C2363771', 'cui_str': 'Myopic astigmatism'}]","[{'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0281658', 'cui_str': 'Intraocular Lymphoma'}, {'cui': 'C0023317', 'cui_str': 'Lens clear'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0225336', 'cui_str': 'Endothelial cell'}, {'cui': 'C0012656', 'cui_str': 'Infectious Disease Vectors'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0009928', 'cui_str': 'Contrast sensitivity'}, {'cui': 'C0429518', 'cui_str': 'Endothelial cell density'}, {'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",41.0,0.0443315,"There was no significant complication in any of the groups.
","[{'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Ghoreishi', 'Affiliation': 'Parsian Vision Science Research Institute, Isfahan, Iran; Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Abolfazl', 'Initials': 'A', 'LastName': 'Kashfi', 'Affiliation': 'Parsian Vision Science Research Institute, Isfahan, Iran. Electronic address: drkashfi@gmail.com.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Peyman', 'Affiliation': 'Parsian Vision Science Research Institute, Isfahan, Iran.'}, {'ForeName': 'Mohadeseh', 'Initials': 'M', 'LastName': 'Mohammadinia', 'Affiliation': 'Parsian Vision Science Research Institute, Isfahan, Iran.'}]",American journal of ophthalmology,['10.1016/j.ajo.2020.06.021']
1247,32623140,Emotion self-regulation training in major depressive disorder using simultaneous real-time fMRI and EEG neurofeedback.,"Simultaneous real-time fMRI and EEG neurofeedback (rtfMRI-EEG-nf) is an emerging neuromodulation approach, that enables simultaneous volitional regulation of both hemodynamic (BOLD fMRI) and electrophysiological (EEG) brain activities. Here we report the first application of rtfMRI-EEG-nf for emotion self-regulation training in patients with major depressive disorder (MDD). In this proof-of-concept study, MDD patients in the experimental group (n = 16) used rtfMRI-EEG-nf during a happy emotion induction task to simultaneously upregulate two fMRI and two EEG activity measures relevant to MDD. The target measures included BOLD activities of the left amygdala (LA) and left rostral anterior cingulate cortex (rACC), and frontal EEG asymmetries in the alpha band (FAA, [7.5-12.5] Hz) and high-beta band (FBA, [21-30] Hz). MDD patients in the control group (n = 8) were provided with sham feedback signals. An advanced procedure for improved real-time EEG-fMRI artifact correction was implemented. The experimental group participants demonstrated significant upregulation of the LA BOLD activity, FAA, and FBA during the rtfMRI-EEG-nf task, as well as significant enhancement in fMRI connectivity between the LA and left rACC. Average individual FAA changes during the rtfMRI-EEG-nf task positively correlated with depression and anhedonia severities, and negatively correlated with after-vs-before changes in depressed mood ratings. Temporal correlations between the FAA and FBA time courses and the LA BOLD activity were significantly enhanced during the rtfMRI-EEG-nf task. The experimental group participants reported significant mood improvements after the training. Our results suggest that the rtfMRI-EEG-nf may have potential for treatment of MDD.",2020,"The experimental group participants demonstrated significant upregulation of the LA BOLD activity, FAA, and FBA during the rtfMRI-EEG-nf task, as well as significant enhancement in fMRI connectivity between the LA and left rACC.",['patients with major depressive disorder (MDD'],"['Emotion self-regulation training', 'rtfMRI-EEG-nf for emotion self-regulation training']","['BOLD activities of the left amygdala (LA) and left rostral anterior cingulate cortex (rACC), and frontal EEG asymmetries in the alpha band (FAA, [7.5-12.5] Hz) and high-beta band (FBA, [21-30] Hz', 'Average individual FAA changes', 'depression and anhedonia severities', 'LA BOLD activity', 'fMRI connectivity', 'LA BOLD activity, FAA, and FBA during the rtfMRI-EEG-nf task']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]","[{'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid structure'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C3163631', 'cui_str': 'Rostral'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate Gyrus'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0332514', 'cui_str': 'Asymmetry'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C0060441', 'cui_str': 'flavone acetic acid'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C4517544', 'cui_str': '12.5'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0178417', 'cui_str': 'Anhedonia'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}]",,0.014664,"The experimental group participants demonstrated significant upregulation of the LA BOLD activity, FAA, and FBA during the rtfMRI-EEG-nf task, as well as significant enhancement in fMRI connectivity between the LA and left rACC.","[{'ForeName': 'Vadim', 'Initials': 'V', 'LastName': 'Zotev', 'Affiliation': 'Laureate Institute for Brain Research, Tulsa, OK, USA. Electronic address: vzotev@laureateinstitute.org.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Mayeli', 'Affiliation': 'Laureate Institute for Brain Research, Tulsa, OK, USA; Electrical and Computer Engineering, University of Oklahoma, Tulsa, OK, USA.'}, {'ForeName': 'Masaya', 'Initials': 'M', 'LastName': 'Misaki', 'Affiliation': 'Laureate Institute for Brain Research, Tulsa, OK, USA.'}, {'ForeName': 'Jerzy', 'Initials': 'J', 'LastName': 'Bodurka', 'Affiliation': 'Laureate Institute for Brain Research, Tulsa, OK, USA; Stephenson School of Biomedical Engineering, University of Oklahoma, Norman, OK, USA. Electronic address: jbodurka@laureateinstitute.org.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2020.102331']
1248,32628922,"Incidence and Outcome of Uveitic Glaucoma in Eyes With Intermediate, Posterior, or Panuveitis Followed up to 10 Years After Randomization to Fluocinolone Acetonide Implant or Systemic Therapy.","PURPOSE


To evaluate long-term risk and outcomes of glaucoma in eyes with intermediate, posterior, and panuveitis managed with systemic or fluocinolone acetonide (0.59 mg, ""implant"") therapy.
DESIGN


Prospective Follow-up of the Multicenter Uveitis Steroid Treatment (MUST) Clinical Trial Cohort.
METHODS


Patients with intermediate, posterior, or panuveitis randomized to implant or systemic therapy (corticosteroid plus immunosuppression in >90%) were followed prospectively for glaucoma incidence and outcome.
RESULTS


Among 405 uveitic at-risk eyes of 232 patients (median follow-up = 6.9 years), 40% (79/196) of eyes assigned and treated with implant and 8% (17/209) of eyes assigned and treated with systemic therapy (censoring eyes receiving an implant on implantation) developed glaucoma (hazard ratio [HR] = 5.9, 95% confidence interval [CI] 3.2, 10.8; P < .001). Adjustment for intraocular pressure (IOP) elevation during follow-up only partially mitigated the association of implant treatment with glaucoma incidence: HR = 3.1 (95% CI 1.6, 6.0); P = .001. Among 112 eyes of 83 patients developing glaucoma, the 5-year cumulative incidence following diagnosis of sustained (2 or more consecutive visits) worsening of mean deviation by ≥6 dB was 20% (95% CI 12%, 33%); 5-year cumulative incidence of sustained worsening of cup-to-disc ratio by ≥0.2 was 26% (95% CI 17%, 39%).
CONCLUSIONS


The implant has substantially higher risk of glaucoma than systemic therapy, a difference not entirely explained by posttreatment IOP elevation. Management of IOP elevation was effective in preventing worsening of glaucoma for the large majority of cases, but even under expert clinical management, some glaucoma worsened. Uveitis cases should be monitored carefully for IOP elevation and glaucoma indefinitely.",2020,"Management of IOP elevation was effective in preventing worsening of glaucoma for the large majority of cases, but even under expert clinical management some glaucoma worsened.","['eyes with intermediate, posterior, and panuveitis managed with systemic or', '112 eyes of 83 patients developing glaucoma', 'Multicenter Uveitis Steroid Treatment (MUST', ' Patients with intermediate, posterior or panuveitis randomized to', 'eyes with intermediate, posterior or panuveitis followed up to 10 years after randomization to']","['systemic therapy', 'implant or systemic therapy (corticosteroid plus immunosuppression', 'fluocinolone acetonide', 'fluocinolone acetonide implant or systemic therapy']","['IOP elevation', 'sustained worsening of cup-to-disc ratio', 'uveitic glaucoma']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0030343', 'cui_str': 'Panuveitis'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0042164', 'cui_str': 'Uveitis'}, {'cui': 'C0149783', 'cui_str': 'Administration of steroid'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0021079', 'cui_str': 'Immunosuppressive therapy'}, {'cui': 'C0016298', 'cui_str': 'fluocinolone acetonide'}]","[{'cui': 'C0578862', 'cui_str': 'Intraocular pressure finding'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0423471', 'cui_str': 'Optic cup/disc ratio'}, {'cui': 'C1281939', 'cui_str': 'Uveitic glaucoma'}]",83.0,0.167216,"Management of IOP elevation was effective in preventing worsening of glaucoma for the large majority of cases, but even under expert clinical management some glaucoma worsened.","[{'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Kempen', 'Affiliation': 'Department of Ophthalmology, Massachusetts Eye and Ear, Boston, Massachusetts, USA; Department of Ophthalmology, Harvard Medical School, Boston, Massachusetts, USA; The MyungSung Christian Medical Center (MCM) Eye Unit, MCM General Hospital and MyungSung Medical School, Addis Ababa, Ethiopia. Electronic address: john_kempen@meei.harvard.edu.'}, {'ForeName': 'Mark L', 'Initials': 'ML', 'LastName': 'Van Natta', 'Affiliation': 'Center for Clinical Trials and Evidence Synthesis, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA; Department of Epidemiology, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Friedman', 'Affiliation': 'Department of Ophthalmology, Massachusetts Eye and Ear, Boston, Massachusetts, USA.'}, {'ForeName': 'Michael M', 'Initials': 'MM', 'LastName': 'Altaweel', 'Affiliation': 'Fundus Photograph Reading Center, Department of Ophthalmology and Visual Sciences, University of Wisconsin, Madison, Wisconsin, USA.'}, {'ForeName': 'Husam', 'Initials': 'H', 'LastName': 'Ansari', 'Affiliation': 'Ophthalmology Consultants of Boston, Boston, Massachusetts, USA.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Dunn', 'Affiliation': 'Mid-Atlantic Retina, Philadelphia, Pennsylvania, USA; The Wills Eye Hospital, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Susan G', 'Initials': 'SG', 'LastName': 'Elner', 'Affiliation': 'The Kellogg Eye Center, Department of Ophthalmology, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Janet T', 'Initials': 'JT', 'LastName': 'Holbrook', 'Affiliation': 'Center for Clinical Trials and Evidence Synthesis, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA; Department of Epidemiology, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'Lyndell L', 'Initials': 'LL', 'LastName': 'Lim', 'Affiliation': 'The Royal Victorian Eye and Ear Hospital, Melbourne, Australia.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Sugar', 'Affiliation': 'Center for Clinical Trials and Evidence Synthesis, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA; Department of Epidemiology, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA; Department of Biostatistics, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'Douglas A', 'Initials': 'DA', 'LastName': 'Jabs', 'Affiliation': 'Center for Clinical Trials and Evidence Synthesis, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA; Department of Epidemiology, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA; The Johns Hopkins University School of Medicine Wilmer Eye Institute, Baltimore, Maryland, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of ophthalmology,['10.1016/j.ajo.2020.06.038']
1249,32629078,Knowledge-Based Assessment of Focal Dose Escalation Treatment Plans in Prostate Cancer.,"PURPOSE


In a randomized focal dose escalation radiation therapy trial for prostate cancer (FLAME), up to 95 Gy was prescribed to the tumor in the dose-escalated arm, with 77 Gy to the entire prostate in both arms. As dose constraints to organs at risk had priority over dose escalation and suboptimal planning could occur, we investigated how well the dose to the tumor was boosted. We developed an anatomy-based prediction model to identify plans with suboptimal tumor dose and performed replanning to validate our model.
METHODS AND MATERIALS


We derived dose-volume parameters from planned dose distributions of 539 FLAME trial patients in 4 institutions and compared them between both arms. In the dose-escalated arm, we determined overlap volume histograms and derived features representing patient anatomy. We predicted tumor D98% with a linear regression on anatomic features and performed replanning on 21 plans.
RESULTS


In the dose-escalated arm, the median tumor D50% and D98% were 93.0 and 84.7 Gy, and 99% of the tumors had a dose escalation greater than 82.4 Gy (107% of 77 Gy). In both arms organs at risk constraints were met. Five out of 73 anatomic features were found to be predictive for tumor D98%. Median predicted tumor D98% was 4.4 Gy higher than planned D98%. Upon replanning, median tumor D98% increased by 3.0 Gy. A strong correlation between predicted increase in D98% and realized increase upon replanning was found (ρ = 0.86).
CONCLUSIONS


Focal dose escalation in prostate cancer was feasible with a dose escalation to 99% of the tumors. Replanning resulted in an increased tumor dose that correlated well with the prediction model. The model was able to identify tumors on which a higher boost dose could be planned. The model has potential as a quality assessment tool in focal dose escalated treatment plans.",2020,Replanning resulted in an increased tumor dose that correlated well with the prediction model.,"['539 [X] patients in 4 institutions and compared them between both arms', 'prostate cancer']",[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0230348', 'cui_str': 'Both upper arms'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}]",[],[],,0.0291957,Replanning resulted in an increased tumor dose that correlated well with the prediction model.,"[{'ForeName': 'Marcel A', 'Initials': 'MA', 'LastName': 'van Schie', 'Affiliation': 'Netherlands Cancer Institute, Radiation Oncology, Amsterdam, The Netherlands. Electronic address: m.v.schie@nki.nl.'}, {'ForeName': 'Tomas M', 'Initials': 'TM', 'LastName': 'Janssen', 'Affiliation': 'Netherlands Cancer Institute, Radiation Oncology, Amsterdam, The Netherlands.'}, {'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Eekhout', 'Affiliation': 'Netherlands Cancer Institute, Radiation Oncology, Amsterdam, The Netherlands.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Walraven', 'Affiliation': 'Netherlands Cancer Institute, Radiation Oncology, Amsterdam, The Netherlands.'}, {'ForeName': 'Floris J', 'Initials': 'FJ', 'LastName': 'Pos', 'Affiliation': 'Netherlands Cancer Institute, Radiation Oncology, Amsterdam, The Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'de Ruiter', 'Affiliation': 'Netherlands Cancer Institute, Radiation Oncology, Amsterdam, The Netherlands.'}, {'ForeName': 'Alexis N T J', 'Initials': 'ANTJ', 'LastName': 'Kotte', 'Affiliation': 'University Medical Center Utrecht, Radiation Oncology, Utrecht, The Netherlands.'}, {'ForeName': 'Evelyn M', 'Initials': 'EM', 'LastName': 'Monninkhof', 'Affiliation': 'University Medical Center Utrecht, Radiation Oncology, Utrecht, The Netherlands.'}, {'ForeName': 'Linda G W', 'Initials': 'LGW', 'LastName': 'Kerkmeijer', 'Affiliation': 'University Medical Center Utrecht, Radiation Oncology, Utrecht, The Netherlands; Radboud University Medical Center, Radiation Oncology, Nijmegen, The Netherlands.'}, {'ForeName': 'Cédric', 'Initials': 'C', 'LastName': 'Draulans', 'Affiliation': 'University Hospitals Leuven, Radiation Oncology, Leuven, Belgium.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'de Roover', 'Affiliation': 'University Hospitals Leuven, Radiation Oncology, Leuven, Belgium.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Haustermans', 'Affiliation': 'University Hospitals Leuven, Radiation Oncology, Leuven, Belgium.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Kunze-Busch', 'Affiliation': 'Radboud University Medical Center, Radiation Oncology, Nijmegen, The Netherlands.'}, {'ForeName': 'Robert Jan', 'Initials': 'RJ', 'LastName': 'Smeenk', 'Affiliation': 'Radboud University Medical Center, Radiation Oncology, Nijmegen, The Netherlands.'}, {'ForeName': 'Uulke A', 'Initials': 'UA', 'LastName': 'van der Heide', 'Affiliation': 'Netherlands Cancer Institute, Radiation Oncology, Amsterdam, The Netherlands.'}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2020.06.072']
1250,32631820,Population Pharmacokinetics of Praziquantel in Pregnant and Lactating Filipino Women Infected with Schistosoma japonicum.,"An estimated 40 million women of reproductive age are infected with one of three species of the waterborne parasite  Schistosoma  spp. Treatment with praziquantel (PZQ) via mass drug administration (MDA) campaigns is the mainstay of schistosomiasis control for populations living in areas of endemicity. The World Health Organization recommends that pregnant and lactating women be included in schistosomiasis MDA programs, and several recent studies have evaluated the safety and efficacy of PZQ use during pregnancy. To date, there are no data describing PZQ pharmacokinetics (PK) during pregnancy or among lactating postpartum women. As part of a randomized controlled trial investigating the safety and efficacy of PZQ during human pregnancy, we examined the PK of this therapeutic drug among three distinct cohorts of women infected with  S. japonicum  in Leyte, Philippines. Specifically, we studied the PK properties of PZQ among early- and late-gestation pregnant women ( n  = 15 each) and lactating postpartum women ( n  = 15) with schistosomiasis. We found that women in early pregnancy had increased apparent clearance and lower area-under-the-curve (AUC 0-24 ) values that may be related to physiological changes in drug clearance and/or changes in oral bioavailability. There was no relationship between body weight and apparent clearance. The mean ± standard deviation partition ratio of plasma to breast milk was 0.36. ± 0.13. The estimated median infant PZQ daily dose would be 0.037 mg/kg of body weight ingested from breast milk, which is significantly lower than the dosage required for antischistosomal activity and not known to be harmful to the infant. Our PK data do not support the suggestion to delay breastfeeding 72 h after taking PZQ. Results can help inform future drug efficacy studies in pregnant and lactating women with schistosomiasis.",2020,There was no relationship between body weight and apparent clearance.,"['populations living in endemic areas', 'three distinct cohorts of women infected with  S. japonicum  in Leyte, The Philippines', 'among early and late gestation pregnant women (N= 15 each) and lactating post-partum women (N=15) with schistosomiasis', 'pregnant and lactating women with schistosomiasis', 'Pregnant and Lactating Filipino Women infected with  Schistosoma japonicum ', 'pregnant and lactating women', 'lactating postpartum women', '40 million women of reproductive age are infected with one of three species of the waterborne parasite  Schistosoma  ( S. ) spp']","['Praziquantel', 'praziquantel (PZQ) via mass drug administration (MDA) campaigns', 'PZQ']","['body weight and apparent clearance', 'PK properties of PZQ', 'mean ± standard deviation partition ratio of plasma to breast milk']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0243130', 'cui_str': 'endemics'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0454753', 'cui_str': 'Leyte'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0036323', 'cui_str': 'Disease due to Schistosomatidae'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C1556093', 'cui_str': 'Filipinos'}, {'cui': 'C0036317', 'cui_str': 'Schistosoma japonicum'}, {'cui': 'C0032804', 'cui_str': 'Postpartum Women'}, {'cui': 'C1881839', 'cui_str': '1000000'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0030498', 'cui_str': 'Parasite'}, {'cui': 'C0036315', 'cui_str': 'Schistosoma'}, {'cui': 'C0074992', 'cui_str': 'sphingosine 1-phosphate'}]","[{'cui': 'C0032911', 'cui_str': 'Praziquantel'}, {'cui': 'C4505223', 'cui_str': 'Mass Administration'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0871161', 'cui_str': 'Property'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0026131', 'cui_str': 'Milk'}]",,0.0915495,There was no relationship between body weight and apparent clearance.,"[{'ForeName': 'Amaya L', 'Initials': 'AL', 'LastName': 'Bustinduy', 'Affiliation': 'Department of Clinical Research, London School of Hygiene & Tropical Medicine, London, United Kingdom Amaya.Bustinduy@lshtm.ac.uk.'}, {'ForeName': 'Ruwanthi', 'Initials': 'R', 'LastName': 'Kolamunnage-Dona', 'Affiliation': 'Department of Biostatistics, University of Liverpool, Liverpool Health Partners, Liverpool, United Kingdom.'}, {'ForeName': 'Mark H', 'Initials': 'MH', 'LastName': 'Mirochnick', 'Affiliation': 'Department of Pediatrics, Boston University School of Medicine, Boston, Massachusetts, USA.'}, {'ForeName': 'Edmund V', 'Initials': 'EV', 'LastName': 'Capparelli', 'Affiliation': 'Department of Pediatrics, University of California, San Diego, La Jolla, California, USA.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Tallo', 'Affiliation': 'Department of Epidemiology, Research Institute of Tropical Medicine, Manila, Philippines.'}, {'ForeName': 'Luz P', 'Initials': 'LP', 'LastName': 'Acosta', 'Affiliation': 'Department of Immunology, Research Institute of Tropical Medicine, Manila, Philippines.'}, {'ForeName': 'Remigio M', 'Initials': 'RM', 'LastName': 'Olveda', 'Affiliation': 'Department of Immunology, Research Institute of Tropical Medicine, Manila, Philippines.'}, {'ForeName': 'Jennifer F', 'Initials': 'JF', 'LastName': 'Friedman', 'Affiliation': 'Department of Pediatrics, Alpert Medical School of Brown University, Providence, Rhode Island, USA.'}, {'ForeName': 'William W', 'Initials': 'WW', 'LastName': 'Hope', 'Affiliation': 'Antimicrobial Pharmacodynamics and Therapeutics, University of Liverpool, Liverpool Health Partners, Liverpool, United Kingdom.'}]",Antimicrobial agents and chemotherapy,['10.1128/AAC.00566-20']
1251,32610351,Impact of Navigated Task-specific fMRI on Direct Cortical Stimulation.,"BACKGROUND AND STUDY AIMS


Cortical mapping (CM) with direct cortical stimulation (DCS) in awake craniotomy is used to preserve cognitive functions such as language. Nevertheless, patient collaboration during this procedure is influenced by previous neurological symptoms and growing discomfort with DCS duration. Our study aimed to evaluate the impact of navigated task-specific functional magnetic resonance imaging (nfMRI) on the practical aspects of DCS.
MATERIAL AND METHODS


We recruited glioma patients scheduled for awake craniotomy for prior fMRI-based CM, acquired during motor and language tasks (i.e., verb generation, semantic and syntactic decision tasks). Language data was combined to generate a probabilistic map indicating brain regions activated with more than one paradigm. Presurgical neurophysiological language tests (i.e., verb generation, picture naming, and semantic tasks) were also performed. We considered for subsequent study only the patients with a minimum rate of correct responses of 50% in all tests. These patients were then randomized to perform intraoperative language CM either using the multimodal approach (mCM), using nfMRI and DCS combined, or electrical CM (eCM), with DCS alone. DCS was done while the patient performed picture naming and nonverbal semantic decision tasks. Methodological features such as DCS duration, number of stimuli, total delivered stimulus duration per task, and frequency of seizures were analyzed and compared between groups. The correspondence between positive responses obtained with DCS and nfMRI was also evaluated.
RESULTS


Twenty-one surgeries were included, thirteen of which using mCM (i.e., test group). Patients with lower presurgical neuropsychological performance (correct response rate between 50 and 80% in language tests) showed a decreased DCS duration in comparison with the control group. None of the compared methodological features showed differences between groups. Correspondence between DCS and nfMRI was 100/84% in the identification of the precentral gyrus for motor function/opercular frontal inferior gyrus for language function, respectively.
CONCLUSION


Navigated fMRI data did not influence DCS in practice. Presurgical language disturbances limited the applicability of DCS mapping in awake surgery.",2020,"Correspondence between DCS and nfMRI was 100/84% in the identification of the precentral gyrus for motor function/opercular frontal inferior gyrus for language function, respectively.
","['awake surgery', 'We recruited glioma patients scheduled for awake craniotomy for prior fMRI-based CM, acquired during motor and language tasks (i.e., verb generation, semantic and syntactic decision tasks', 'Twenty-one surgeries were included, thirteen of which using mCM (i.e., test group']","['navigated task-specific functional magnetic resonance imaging (nfMRI', 'direct cortical stimulation (DCS', 'Navigated Task-specific fMRI', 'intraoperative language CM either using the multimodal approach (mCM), using nfMRI and DCS combined, or electrical CM (eCM), with DCS alone']","['presurgical neuropsychological performance (correct response rate', 'Presurgical neurophysiological language tests (i.e., verb generation, picture naming, and semantic tasks', 'DCS duration, number of stimuli, total delivered stimulus duration per task, and frequency of seizures', 'DCS duration']","[{'cui': 'C0234422', 'cui_str': 'Awake'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0017638', 'cui_str': 'Glioma'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0010280', 'cui_str': 'Craniotomy'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C1283195', 'cui_str': 'Mapping - action'}, {'cui': 'C0439661', 'cui_str': 'Acquired'}, {'cui': 'C0347984', 'cui_str': 'During'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0036612', 'cui_str': 'Semantics'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0439201', 'cui_str': 'um'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C1283195', 'cui_str': 'Mapping - action'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}]","[{'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0023016', 'cui_str': 'Language Tests'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C0036612', 'cui_str': 'Semantics'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0449802', 'cui_str': 'Number of stimuli'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}]",21.0,0.173939,"Correspondence between DCS and nfMRI was 100/84% in the identification of the precentral gyrus for motor function/opercular frontal inferior gyrus for language function, respectively.
","[{'ForeName': 'Joao', 'Initials': 'J', 'LastName': 'Leote', 'Affiliation': 'Faculdade de Ciências da Universidade de Lisboa, Instituto de Biofísica e Engenharia Biomédica, Lisboa, Portugal.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Loução', 'Affiliation': 'Institute of Neurosciences and Medicine, INM 4, Julich, Nordrhein-Westfalen, Germany.'}, {'ForeName': 'Catarina', 'Initials': 'C', 'LastName': 'Viegas', 'Affiliation': 'Department of Neurosurgery and Critical Care, Hospital Garcia de Orta EPE, Almada, Portugal.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Lauterbach', 'Affiliation': 'Department of Neuroradiology, Sociedade Portuguesa de Ressonância Magnética, Lisboa, Portugal.'}, {'ForeName': 'António', 'Initials': 'A', 'LastName': 'Perez-Hick', 'Affiliation': 'Department of Neurosurgery and Critical Care, Hospital Garcia de Orta EPE, Almada, Portugal.'}, {'ForeName': 'Joana', 'Initials': 'J', 'LastName': 'Monteiro', 'Affiliation': 'Department of Neurosurgery and Critical Care, Hospital Garcia de Orta EPE, Almada, Portugal.'}, {'ForeName': 'Rita G', 'Initials': 'RG', 'LastName': 'Nunes', 'Affiliation': 'Department of Bioengineering and Institute for Systems and Robotics (ISR/IST), LARSyS, Universidade de Lisboa Instituto Superior Técnico Campus Alameda, Lisboa, Lisboa, Portugal.'}, {'ForeName': 'Hugo A', 'Initials': 'HA', 'LastName': 'Ferreira', 'Affiliation': 'Faculdade de Ciências da Universidade de Lisboa, Instituto de Biofísica e Engenharia Biomédica, Lisboa, Portugal.'}]","Journal of neurological surgery. Part A, Central European neurosurgery",['10.1055/s-0040-1712496']
1252,32617000,Vestibular Rehabilitation Using Posturographic System in Elderly Patients with Postural Instability: Can the Number of Sessions Be Reduced?,"Purpose


Vestibular rehabilitation (VR) using posturography systems has proved useful in improving balance among elderly patients with postural instability. However, its high cost hinders its use. The objective of this study is to assess whether two different protocols of VR with posturography, one of them longer (ten sessions) and the other shorter (five sessions), show significant differences in the improvement of balance among old patients with instability.
Patients and Methods


This is a prospective, experimental, single-center (Department of Otorhinolaryngology of a tertiary referral hospital), randomized (into balanced patient blocks) study with two parallel arms, in 40 people over 65 years of age, with instability and at a high risk of falling. The percentage of the average balance (composite) in the sensory organization test (SOT) of the CDP (main outcome measure), other CDP scores, time and steps in the ""timed up and go"" test, scores of Dizziness Handicap Inventory (DHI), short Falls Efficacy Scale - International (short FES-I), and Vertiguard were compared before and 3 weeks after VR between both intervention groups.
Results


The two treatment groups (20 patients per group) were comparable in age, sex, and pre-VR balance evaluation. In both groups, we observed a significant improvement in global balance (composite) after VR (49±11.34 vs 57±13.48, p=0.007, in the group undergoing 10 sessions; 51±12.55 vs 60±12.99, p=0.002, 5 sessions). In both groups, we also observed improvements in other posturographic parameters (in the SOT and limits of stability) but not in the timed up and go scores or in the questionnaires. Comparison of the improvement level achieved in both groups revealed no significant differences between them.
Conclusion


The protocols of vestibular rehabilitation by posturography of 5 sessions in elderly patients with postural instability are as effective as those of 10 sessions for improving balance among elderly patients with postural instability.
Trial Registration


ClinicalTrials.gov identifier: NCT03034655. Registered on 25 January 2017.",2020,"In both groups, we observed a significant improvement in global balance (composite) after VR (49±11.34 vs 57±13.48, p=0.007, in the group undergoing 10 sessions; 51±12.55 vs 60±12.99, p=0.002, 5 sessions).","['single-center (Department of Otorhinolaryngology of a tertiary referral hospital', 'old patients with instability', 'elderly patients with postural instability', 'Elderly Patients with Postural Instability', '40 people over 65 years of age, with instability and at a high risk of falling']","['Vestibular rehabilitation (VR) using posturography systems', 'Vestibular Rehabilitation Using Posturographic System', 'vestibular rehabilitation by posturography of 5 sessions']","['global balance (composite) after VR', 'posturographic parameters', 'CDP scores, time and steps in the ""timed up and go"" test, scores of Dizziness Handicap Inventory (DHI), short Falls Efficacy Scale - International (short FES-I), and Vertiguard']","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0029892', 'cui_str': 'Otolaryngology'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085633', 'cui_str': 'Mood swings'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1843921', 'cui_str': 'Postural instability'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}]","[{'cui': 'C0200324', 'cui_str': 'Vestibular rehabilitation'}, {'cui': 'C0919611', 'cui_str': 'Posturography'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0200324', 'cui_str': 'Vestibular rehabilitation'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0008188', 'cui_str': 'Chlordiazepoxide'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0231172', 'cui_str': 'Handicap'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C2919878', 'cui_str': 'Short falls efficacy scale - international'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}]",,0.0168765,"In both groups, we observed a significant improvement in global balance (composite) after VR (49±11.34 vs 57±13.48, p=0.007, in the group undergoing 10 sessions; 51±12.55 vs 60±12.99, p=0.002, 5 sessions).","[{'ForeName': 'Andrés', 'Initials': 'A', 'LastName': 'Soto-Varela', 'Affiliation': 'Division of Neurotology, Department of Otorhinolaryngology, Complexo Hospitalario Universitario, Santiago de Compostela, Spain.'}, {'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'Rossi-Izquierdo', 'Affiliation': 'Department of Otorhinolaryngology, University Hospital Lucus Augusti, Lugo, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Del-Río-Valeiras', 'Affiliation': 'Department of Otorhinolaryngology, Complexo Hospitalario Universitario, Santiago de Compostela, Spain.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Vaamonde-Sánchez-Andrade', 'Affiliation': 'Department of Otorhinolaryngology, Complexo Hospitalario Universitario, Santiago de Compostela, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Faraldo-García', 'Affiliation': 'Department of Otorhinolaryngology, Complexo Hospitalario Universitario, Santiago de Compostela, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Lirola-Delgado', 'Affiliation': 'Department of Otorhinolaryngology, Complexo Hospitalario Universitario, Santiago de Compostela, Spain.'}, {'ForeName': 'Sofía', 'Initials': 'S', 'LastName': 'Santos-Pérez', 'Affiliation': 'Division of Neurotology, Department of Otorhinolaryngology, Complexo Hospitalario Universitario, Santiago de Compostela, Spain.'}]",Clinical interventions in aging,['10.2147/CIA.S263302']
1253,32621047,A time to revisit the two oldest prandial anti-diabetes agents: acarbose and repaglinide.,"PURPOSE


Compared with newer prandial anti-diabetes agents, repaglinide and acarbose are unique in being globally available in generic versions, being oral, and being the cheapest of all. The aim of this study was to compare their efficacy when used alone or in combination.
METHODS


In a randomized, double-blind, prospective study, 358 recently diagnosed type 2 diabetes (T2D) patients, who on a combined therapy with metformin and insulin glargine had a fasting plasma glucose (FGP) of <7.2 mmol/L but a 2-h postprandial plasma glucose (2hPPG) >10 mmol/L, were assigned to three groups of additional treatment with either repaglinide, acarbose, or repaglinide-plus-acarbose for 4 months.
RESULTS


With intention-to-treat analysis, 63% of repaglinide group, 45.4 percent of acarbose group, and 75.7% of repaglinide-plus-acarbose group reached the primary endpoint of 2hPPG < 10 mmol/L while maintaining FPG < 7.2 mmol/L. Treatment adherence rate was 75.6% with repaglinide, 61.4% with acarbose, and 81.3% with repaglinide-plus-acarbose (p = 0.001). Among the groups, weight was significantly lower in acarbose group (p < 0.05). Twenty-one percent of repaglinide patients, 4.9% of acarbose subjects, and 10.3% of repaglinide-plus-acarbose cases reported at least one episode of hypoglycemia (p < 0.005). HbA1C and basal insulin requirement were significantly lower in repaglinide group (p = 0.004, p = 0.0002). Triglycerides were lowest in acarbose group (p = 0.005).
CONCLUSIONS


Both acarbose and repaglinide were vastly effective in lowering postprandial hyperglycemia of recently diagnosed T2D. When combined, they were even more efficacious and the disease had a better outcome. Compared with newer peers, these two are particularly useful where and when cost consideration in diabetes treatment is a prime concern.",2020,Both acarbose and repaglinide were vastly effective in lowering postprandial hyperglycemia of recently diagnosed T2D.,"['had a fasting plasma glucose (FGP) of <7.2\u2009mmol/L but a 2-h postprandial plasma glucose (2hPPG', '358 recently diagnosed type 2 diabetes (T2D) patients, who on a combined therapy with']","['repaglinide-plus-acarbose', 'acarbose and repaglinide', 'repaglinide', 'acarbose', 'prandial anti-diabetes agents, repaglinide and acarbose', 'metformin and insulin glargine', 'repaglinide, acarbose, or repaglinide-plus-acarbose']","['weight', 'HbA1C and basal insulin requirement', 'adherence rate', 'postprandial hyperglycemia', 'Triglycerides', 'episode of hypoglycemia']","[{'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C4517857', 'cui_str': '7.2'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033972', 'cui_str': 'Combined therapy'}]","[{'cui': 'C0246689', 'cui_str': 'repaglinide'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0050393', 'cui_str': 'Acarbose'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C1855520', 'cui_str': 'Postprandial Hyperglycemia'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}]",358.0,0.0419812,Both acarbose and repaglinide were vastly effective in lowering postprandial hyperglycemia of recently diagnosed T2D.,"[{'ForeName': 'Parisa', 'Initials': 'P', 'LastName': 'Pishdad', 'Affiliation': 'Shiraz Medical School, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Pishdad', 'Affiliation': 'Department of Internal Medicine, Rutgers New Jersey Medical School, Newark, NJ, USA.'}, {'ForeName': 'Gholam Reza', 'Initials': 'GR', 'LastName': 'Pishdad', 'Affiliation': 'Endocrine and Metabolism Research Center, Shiraz University of Medical Sciences, Shiraz, Iran. pishdadg@sums.ac.ir.'}, {'ForeName': 'Yunes', 'Initials': 'Y', 'LastName': 'Panahi', 'Affiliation': ""Chemical Injuries Research Center, Tehran's Baqiyatallah University of Medical Sciences, Tehran, Iran.""}]",Endocrine,['10.1007/s12020-020-02396-0']
1254,32627570,Multi-component communication intervention for children with autism: A randomized controlled trial.,"LAY ABSTRACT


This study reports the results of a randomized trial for preverbal preschoolers with autism that demonstrates the effects of multiple intervention strategies including caregiver training. About 50% of children with autism are not talking by age 3 and up to 30% of children with autism will remain minimally verbal past age 5. Interventions delivered by clinicians and caregivers have the greatest effects on spoken language and may reduce the rate of those who remain minimally verbal. Sixty-eight children ages 3-5 with autism and their caregivers participated in this randomized trial comparing the communication intervention to a comparison group. A brief, multi-component, communication intervention (including a speech-generating device) for children with autism that addresses core deficits may be effective in improving joint attention skills immediately following intervention and social communication skills 4 months following intervention. Future research is needed to understand for whom and under what conditions this intervention is most effective.",2020,"A brief, multi-component, communication intervention (including a speech-generating device) for children with autism that addresses core deficits may be effective in improving joint attention skills immediately following intervention and social communication skills 4 months following intervention.","['children with autism', 'Sixty-eight children ages 3-5 with autism and their caregivers participated', 'preverbal preschoolers with autism']","['Multi-component communication intervention', 'multi-component, communication intervention (including a speech-generating device', 'communication intervention']",['joint attention skills'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0450387', 'cui_str': '68'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0442758', 'cui_str': '3/5'}, {'cui': 'C0008100', 'cui_str': 'Preschool child'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C1274143', 'cui_str': 'Communication interventions'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",68.0,0.043766,"A brief, multi-component, communication intervention (including a speech-generating device) for children with autism that addresses core deficits may be effective in improving joint attention skills immediately following intervention and social communication skills 4 months following intervention.","[{'ForeName': 'Lauren H', 'Initials': 'LH', 'LastName': 'Hampton', 'Affiliation': 'University of Texas at Austin, USA.'}, {'ForeName': 'Ann P', 'Initials': 'AP', 'LastName': 'Kaiser', 'Affiliation': 'Vanderbilt University, USA.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Fuller', 'Affiliation': 'Vanderbilt University, USA.'}]",Autism : the international journal of research and practice,['10.1177/1362361320934558']
1255,32623637,Effects of glucagon-like peptide-1 receptor agonists on fluid intake in healthy volunteers.,"PURPOSE


Glucagon-like peptide-1 (GLP-1) receptor agonists (RA) reduce appetite and energy intake. Recent findings from animal studies suggest a role of GLP-1 in drinking and water homeostasis. We aimed to elucidate whether GLP-1 RA reduce fluid intake in healthy volunteers.
METHODS


Double-blind, randomized, placebo-controlled, crossover study. 20 healthy volunteers received dulaglutide 1.5 mg and placebo (0,9% sodium chloride) subcutaneously once weekly for 3 weeks. At the end of each treatment period, participants attended an 8-h evaluation visit, during which they were requested to eat two standardized meals and to drink water ad libitum. The primary outcome was the total fluid intake (ml) during the evaluation visit.
RESULTS


Mean [SD] age of participants (60% female) was 27 [9.2] years. All but four participants drank less on dulaglutide versus placebo treatment despite identical food intake. The median [IQR] difference of fluid intake on dulaglutide compared to placebo treatment was -100 ml [-400-0]. Median [IQR] total fluid intake was 1300 ml [888-1600] versus 1600 ml [1000-1720], on dulaglutide and placebo treatment, p = 0.06. Median [IQR] 24-h urine output was reduced in dulaglutide versus placebo-treated participants: 1250 ml [975-2080] versus 1680 ml [1400-2040], p = 0.04. Median serum sodium levels were 140 mmol/L on both visits and no difference in thirst perception was noted.
CONCLUSIONS


GLP-1 RA such as dulaglutide seem to modulate fluid balance in humans. This leads us to speculate that GLP-1 RA may be an interesting therapeutic options for patients with excessive drinking behavior e.g., primary polydipsia.",2020,"Median [IQR] 24-h urine output was reduced in dulaglutide versus placebo-treated participants: 1250 ml [975-2080] versus 1680 ml [1400-2040], p = 0.04.","['20 healthy volunteers', 'healthy volunteers', 'Mean [SD] age of participants (60% female) was 27 [9.2] years', 'patients with excessive drinking behavior e.g., primary polydipsia']","['Glucagon-like peptide-1', 'dulaglutide 1.5\u2009mg and placebo (0,9% sodium chloride', 'GLP-1 RA', 'glucagon-like peptide-1 receptor agonists', 'placebo']","['Median [IQR] 24-h urine output', 'total fluid intake (ml) during the evaluation visit', 'Median [IQR] total fluid intake', 'median [IQR] difference of fluid intake', 'Median serum sodium levels', 'thirst perception']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C5191219', 'cui_str': '9.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0683357', 'cui_str': 'Excessive drinking'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0268813', 'cui_str': 'Dipsogenic diabetes insipidus'}]","[{'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C3179549', 'cui_str': 'dulaglutide'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}, {'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0232856', 'cui_str': 'Rate of urine output, function'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0429791', 'cui_str': 'Fluid intake'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0523891', 'cui_str': 'Sodium measurement, serum'}, {'cui': 'C0039971', 'cui_str': 'Thirst'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",20.0,0.630076,"Median [IQR] 24-h urine output was reduced in dulaglutide versus placebo-treated participants: 1250 ml [975-2080] versus 1680 ml [1400-2040], p = 0.04.","[{'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Winzeler', 'Affiliation': 'Department of Endocrinology, Diabetology and Metabolism, University Hospital Basel, Basel, Switzerland. bettina.winzeler@usb.ch.'}, {'ForeName': 'Ismael', 'Initials': 'I', 'LastName': 'da Conceição', 'Affiliation': 'Department of Endocrinology, Diabetology and Metabolism, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Refardt', 'Affiliation': 'Department of Endocrinology, Diabetology and Metabolism, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Clara O', 'Initials': 'CO', 'LastName': 'Sailer', 'Affiliation': 'Department of Endocrinology, Diabetology and Metabolism, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Dutilh', 'Affiliation': 'Department of Clinical Research, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Mirjam', 'Initials': 'M', 'LastName': 'Christ-Crain', 'Affiliation': 'Department of Endocrinology, Diabetology and Metabolism, University Hospital Basel, Basel, Switzerland.'}]",Endocrine,['10.1007/s12020-020-02394-2']
1256,32634820,Serial assessment of fat and fat-free mass accretion in very preterm infants: a randomized trial.,"BACKGROUND


Clinicians could modify dietary interventions during early infancy by monitoring fat and fat-free mass accretion in very preterm infants.
METHODS


Preterm infants were randomly assigned to either having reports on infant body composition available to the clinicians caring for them (intervention group) or not having reports available (control group). All infants underwent serial assessments of body composition by air-displacement plethysmography before 32 weeks of postmenstrual age (PMA) and at 36 weeks PMA. The primary outcome was percent body fat (%BF) at 3 months of corrected age (CA).
RESULTS


Fifty infants were randomized (median gestational age: 30 weeks; mean ± SD birth weight: 1387 ± 283 g). The mean %BF increased from 7 ± 4 before 32 weeks PMA to 20 ± 5 at 3 months CA. The differences in mean %BF between the intervention group and the control group were not statistically significant at 36 weeks PMA (14.5 vs. 13.6) or 3 months CA (20.8 vs. 19.4). Feeding practices and anthropometric measurements during hospitalization did not differ between groups.
CONCLUSIONS


Serial assessments of body composition in both intervention and control groups showed consistent increments in %BF. However, providing this information to clinicians did not influence nutritional practices or growth.
IMPACT


Serial assessments of body composition in preterm infants at 32 and 36 weeks postmenstrual age show consistent increments in % body fat up to 3 months of corrected age. However, providing this information to the clinician did not influence nutritional practices or growth.",2020,The differences in mean %BF between the intervention group and the control group were not statistically significant at 36 weeks PMA (14.5 vs. 13.6) or 3 months CA (20.8 vs. 19.4).,"['very preterm infants', 'Fifty infants were randomized (median gestational age: 30 weeks; mean\u2009±\u2009SD birth weight: 1387\u2009±\u2009283\u2009g', 'Preterm infants', 'preterm infants at 32 and 36 weeks postmenstrual age']","['Serial assessment of fat and fat-free mass accretion', 'having reports on infant body composition available to the clinicians caring for them (intervention group) or not having reports available (control group']","['body composition', 'mean %BF', 'percent body fat (%BF']","[{'cui': 'C3897192', 'cui_str': 'Very preterm infant'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C4708786', 'cui_str': '283'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C0333038', 'cui_str': 'Accretion'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}]",50.0,0.0677656,The differences in mean %BF between the intervention group and the control group were not statistically significant at 36 weeks PMA (14.5 vs. 13.6) or 3 months CA (20.8 vs. 19.4).,"[{'ForeName': 'Ariel A', 'Initials': 'AA', 'LastName': 'Salas', 'Affiliation': 'Department of Pediatrics, University of Alabama at Birmingham, Birmingham, AL, 35249, USA. asalas@peds.uab.edu.'}, {'ForeName': 'Maggie L', 'Initials': 'ML', 'LastName': 'Jerome', 'Affiliation': 'Department of Nutrition Sciences, University of Alabama at Birmingham, Birmingham, AL, 35249, USA.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Chandler-Laney', 'Affiliation': 'Department of Nutrition Sciences, University of Alabama at Birmingham, Birmingham, AL, 35249, USA.'}, {'ForeName': 'Namasivayam', 'Initials': 'N', 'LastName': 'Ambalavanan', 'Affiliation': 'Department of Pediatrics, University of Alabama at Birmingham, Birmingham, AL, 35249, USA.'}, {'ForeName': 'Waldemar A', 'Initials': 'WA', 'LastName': 'Carlo', 'Affiliation': 'Department of Pediatrics, University of Alabama at Birmingham, Birmingham, AL, 35249, USA.'}]",Pediatric research,['10.1038/s41390-020-1052-x']
1257,32641226,Sacubitril/Valsartan in Advanced Heart Failure With Reduced Ejection Fraction: Rationale and Design of the LIFE Trial.,"The PARADIGM-HF (Prospective Comparison of Angiotensin II Receptor Blocker Neprilysin Inhibitor With Angiotensin-Converting Enzyme Inhibitor to Determine Impact on Global Mortality and Morbidity in Heart Failure) trial reported that sacubitril/valsartan (S/V), an angiotensin receptor-neprilysin inhibitor, significantly reduced mortality and heart failure (HF) hospitalization in HF patients with a reduced ejection fraction (HFrEF). However, fewer than 1% of patients in the PARADIGM-HF study had New York Heart Association (NYHA) functional class IV symptoms. Accordingly, data that informed the use of S/V among patients with advanced HF were limited. The LIFE (LCZ696 in Hospitalized Advanced Heart Failure) study was a 24-week prospective, multicenter, double-blinded, double-dummy, active comparator trial that compared the safety, efficacy, and tolerability of S/V with those of valsartan in patients with advanced HFrEF. The trial planned to randomize 400 patients ≥18 years of age with advanced HF, defined as an EF ≤35%, New York Heart Association functional class IV symptoms, elevated natriuretic peptide concentration (B-type natriuretic peptide [BNP] ≥250 pg/ml or N-terminal pro-B-type natriuretic peptide [NT-proBNP] ≥800 pg/ml), and ≥1 objective finding of advanced HF. Following a 3- to 7-day open label run-in period with S/V (24 mg/26 mg twice daily), patients were randomized 1:1 to S/V titrated to 97 mg/103 mg twice daily versus 160 mg of V twice daily. The primary endpoint was the proportional change from baseline in the area under the curve for NT-proBNP levels measured through week 24. Secondary and tertiary endpoints included clinical outcomes and safety and tolerability. Because of the COVID-19 pandemic, enrollment in the LIFE trial was stopped prematurely to ensure patient safety and data integrity. The primary analysis consists of the first 335 randomized patients whose clinical follow-up examination results were not severely impacted by COVID-19. (Entresto [LCZ696] in Advanced Heart Failure [LIFE STUDY] [HFN-LIFE]; NCT02816736).",2020,The primary endpoint was the proportional change from baseline in the area under the curve for NT-proBNP levels measured through week 24.,"['400 patients\xa0≥18 years of age with advanced HF, defined as an EF\xa0≤35%, New York Heart Association functional class IV symptoms, elevated natriuretic peptide concentration (B-type natriuretic peptide [BNP]\xa0≥250 pg/ml or N-terminal pro-B-type natriuretic peptide [NT-proBNP]\xa0≥800 pg/ml), and\xa0≥1 objective finding of advanced HF', 'patients with advanced HF', 'Failure With Reduced Ejection Fraction', 'Heart\xa0Failure', 'Advanced Heart\xa0Failure [LIFE STUDY', 'HF patients with a reduced ejection fraction (HFrEF', 'Advanced Heart', 'patients with advanced HFrEF']","['Entresto [LCZ696', 'valsartan', 'Angiotensin II Receptor Blocker Neprilysin Inhibitor', 'Angiotensin-Converting Enzyme Inhibitor', 'sacubitril/valsartan', 'Sacubitril/Valsartan', 'LIFE (LCZ696']","['mortality and heart failure (HF) hospitalization', 'proportional change from baseline in the area under the curve for NT-proBNP levels', 'Global Mortality and Morbidity', 'safety, efficacy, and tolerability', 'clinical outcomes and safety and tolerability']","[{'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0441888', 'cui_str': 'Class 4'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1144709', 'cui_str': 'Natriuretic Peptide Hormones'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0439297', 'cui_str': 'ng/L'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C4033616', 'cui_str': 'Entresto'}, {'cui': 'C2933615', 'cui_str': 'LCZ 696'}, {'cui': 'C0216784', 'cui_str': 'valsartan'}, {'cui': 'C0521942', 'cui_str': 'Angiotensin II receptor antagonist'}, {'cui': 'C4760695', 'cui_str': 'Neprilysin inhibitor'}, {'cui': 'C0003015', 'cui_str': 'Angiotensin-converting enzyme inhibitor'}, {'cui': 'C4033631', 'cui_str': 'valsartan and sacubitril'}, {'cui': 'C0376558', 'cui_str': 'Life'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0205351', 'cui_str': 'Proportional'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",335.0,0.331951,The primary endpoint was the proportional change from baseline in the area under the curve for NT-proBNP levels measured through week 24.,"[{'ForeName': 'Douglas L', 'Initials': 'DL', 'LastName': 'Mann', 'Affiliation': 'Department of Medicine, Washington University, St. Louis, Missouri. Electronic address: dmann@wustl.edu.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Greene', 'Affiliation': 'Department of Medicine, Duke University, Durham, North Carolina; Duke Clinical Research Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Michael M', 'Initials': 'MM', 'LastName': 'Givertz', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Justin M', 'Initials': 'JM', 'LastName': 'Vader', 'Affiliation': 'Department of Medicine, Washington University, St. Louis, Missouri.'}, {'ForeName': 'Randall C', 'Initials': 'RC', 'LastName': 'Starling', 'Affiliation': 'Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Andrew P', 'Initials': 'AP', 'LastName': 'Ambrosy', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, California.'}, {'ForeName': 'Palak', 'Initials': 'P', 'LastName': 'Shah', 'Affiliation': 'Inova Heart and Vascular Institute, Falls Church, Virginia.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'McNulty', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Claudius', 'Initials': 'C', 'LastName': 'Mahr', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, Washington.'}, {'ForeName': 'Divya', 'Initials': 'D', 'LastName': 'Gupta', 'Affiliation': 'Department of Medicine, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Margaret M', 'Initials': 'MM', 'LastName': 'Redfield', 'Affiliation': 'Division of Cardiovascular Diseases, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Anuradha', 'Initials': 'A', 'LastName': 'Lala', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Gregory D', 'Initials': 'GD', 'LastName': 'Lewis', 'Affiliation': 'Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Selma F', 'Initials': 'SF', 'LastName': 'Mohammed', 'Affiliation': 'MedStar Washington Hospital Center, Washington, DC.'}, {'ForeName': 'Nisha A', 'Initials': 'NA', 'LastName': 'Gilotra', 'Affiliation': 'Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Adam D', 'Initials': 'AD', 'LastName': 'DeVore', 'Affiliation': 'Department of Medicine, Duke University, Durham, North Carolina; Duke Clinical Research Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Eiran Z', 'Initials': 'EZ', 'LastName': 'Gorodeski', 'Affiliation': 'Department of Medicine, Harrington Heart and Vascular Center, Case Western Reserve University School of Medicine, Cleveland, Ohio.'}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Desvigne-Nickens', 'Affiliation': 'Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, Baltimore, Maryland.'}, {'ForeName': 'Adrian F', 'Initials': 'AF', 'LastName': 'Hernandez', 'Affiliation': 'Department of Medicine, Duke University, Durham, North Carolina; Duke Clinical Research Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Braunwald', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JACC. Heart failure,['10.1016/j.jchf.2020.05.005']
1258,32684362,"Conjugated linoleic acid supplements preserve muscle in high-body-fat adults: A double-blind, randomized, placebo trial.","BACKGROUND AND AIMS


Conjugated linoleic acid (CLA) has been used to improve body composition in weight management. However, clinical trial results are inconsistent and limited among Asians. We aimed to investigate the effect of CLA on body composition of Chinese adults with elevated body fat percentage.
METHODS AND RESULTS


In this double-blind, randomized, placebo-controlled trial, 66 Chinese adults (aged 18-45 years old, 37.9% male) with elevated body fat percentage were provided with 3.2 g/day CLA (n = 33) or 3.2 g/day placebo (sunflower oil; n = 33) for 12 weeks. Both groups received lifestyle counseling, featured with low fat and low sugar diet, and moderate physical activity. Body composition was measured using dual-energy X-ray absorptiometry at the baseline and end of the trial. Sixty-four participants finished this study. Compared with the placebo group, the CLA group showed increased trunk muscle mass (MM) (0.6 ± 1.7 vs. -0.3 ± 1.2 kg, P = 0.019). Among those with an adherence score higher than 0.80 (n = 56, 87.5%), a greater increase in both total and trunk MM was observed in the CLA group (both P < 0.05). Moreover, the effect on MM appeared to be more evident in men, those with a body mass index <25 kg/m 2 , or those with higher self-rated physical activity.
CONCLUSIONS


In Chinese adults with elevated body fat percentage, 3.2 g/day CLA supplementation may be effective in preserving MM, especially in the trunk region.
REGISTRATION


This study was registered at ClinicalTrials.gov as NCT03915808 on April 9, 2019.",2020,"Compared with the placebo group, the CLA group showed increased trunk muscle mass (MM) (0.6 ± 1.7 vs. -0.3 ± 1.2 kg, P = 0.019).","['high-body-fat adults', 'Chinese adults with elevated body fat percentage', '66 Chinese adults (aged 18-45 years old, 37.9% male) with elevated body fat percentage were provided with 3.2\xa0g/day']","['CLA', 'CLA supplementation', 'placebo', 'lifestyle counseling, featured with low fat and low sugar diet', 'Conjugated linoleic acid supplements', 'Conjugated linoleic acid (CLA']","['total and trunk MM', 'trunk muscle mass (MM', 'Body composition']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C4517687', 'cui_str': '3.2'}, {'cui': 'C0439417', 'cui_str': 'g/24h'}]","[{'cui': 'C0050156', 'cui_str': '9,11-linoleic acid'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0730543', 'cui_str': 'Lifestyle education'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0242970', 'cui_str': 'Low fat diet'}, {'cui': 'C0452316', 'cui_str': 'Low sugar diet'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0581755', 'cui_str': 'Skeletal muscle structure of trunk'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}]",66.0,0.699676,"Compared with the placebo group, the CLA group showed increased trunk muscle mass (MM) (0.6 ± 1.7 vs. -0.3 ± 1.2 kg, P = 0.019).","[{'ForeName': 'Huan', 'Initials': 'H', 'LastName': 'Chang', 'Affiliation': ""Department of Nutrition and Food Safety, School of Public Health, Xi'an Jiaotong University Health Science Center, 76 West Yanta Road, 710061, Xi'an, Shaanxi, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Gan', 'Affiliation': 'Medical Research Council Population Health Research Unit at the University of Oxford, Oxford, OX3 7LF, UK; Clinical Trial Service Unit and Epidemiological Studies Unit (CTSU), Nuffield Department of Population Health, University of Oxford, Oxford, OX3 7LF, UK.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Liao', 'Affiliation': ""Department of Nutrition, The First Affiliated Hospital, Xi'an Jiaotong University Health Science Center, 277 West Yanta Road, 710061, Xi'an, Shaanxi, China.""}, {'ForeName': 'Junxiang', 'Initials': 'J', 'LastName': 'Wei', 'Affiliation': ""Department of Epidemiology and Biostatistics, School of Public Health, Xi'an Jiaotong University Health Science Center, 76 West Yanta Road, 710061, Xi'an, Shaanxi, China.""}, {'ForeName': 'Mengnan', 'Initials': 'M', 'LastName': 'Lu', 'Affiliation': ""Xi'an Jiaotong University Health Science Center, 76 West Yanta Road, 710061, Xi'an, Shaanxi, China.""}, {'ForeName': 'Huangtao', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': ""Xi'an Jiaotong University Health Science Center, 76 West Yanta Road, 710061, Xi'an, Shaanxi, China.""}, {'ForeName': 'Shenglong', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': ""Xi'an Jiaotong University Health Science Center, 76 West Yanta Road, 710061, Xi'an, Shaanxi, China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': ""School of Sports and Health Sciences, Xi'an Physical Education University, 65 North Hanguang Road, 710068, Xi'an, Shaanxi, China.""}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Wu', 'Affiliation': ""Department of Epidemiology and Biostatistics, School of Public Health, Xi'an Jiaotong University Health Science Center, 76 West Yanta Road, 710061, Xi'an, Shaanxi, China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': ""Department of Nutrition and Food Safety, School of Public Health, Xi'an Jiaotong University Health Science Center, 76 West Yanta Road, 710061, Xi'an, Shaanxi, China. Electronic address: yuyan@xjtu.edu.cn.""}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': ""Department of Epidemiology and Biostatistics, School of Public Health, Xi'an Jiaotong University Health Science Center, 76 West Yanta Road, 710061, Xi'an, Shaanxi, China. Electronic address: xinliu@xjtu.edu.cn.""}]","Nutrition, metabolism, and cardiovascular diseases : NMCD",['10.1016/j.numecd.2020.05.029']
1259,32623370,"Drainage, irrigation and fibrinolytic therapy (DRIFT) for posthaemorrhagic ventricular dilatation: 10-year follow-up of a randomised controlled trial.","BACKGROUND


Progressive ventricular dilatation after intraventricular haemorrhage (IVH) in preterm infants has a very high risk of severe disability and death. Drainage, irrigation and fibrinolytic therapy (DRIFT), in a randomised controlled trial (RCT), reduced severe cognitive impairment at 2 years.
OBJECTIVE


To assess if the cognitive advantage of DRIFT seen at 2 years persisted until school age.
PARTICIPANTS


The RCT conducted in four centres recruited 77 preterm infants with IVH and progressive ventricular enlargement over specified measurements. Follow-up was at 10 years of age.
INTERVENTION


Intraventricular injection of a fibrinolytic followed by continuous lavage, until the drainage was clear, and standard care consisting of control of expansion by lumbar punctures and if expansion persisted via a ventricular access device.
PRIMARY OUTCOME


Cognitive quotient (CQ), derived from the British Ability Scales and Bayley III Scales, and survival without severe cognitive disability.
RESULTS


Of the 77 children randomised, 12 died, 2 could not be traced, 10 did not respond and 1 declined at 10-year follow-up. 28 in the DRIFT group and 24 in the standard treatment group were assessed by examiners blinded to the intervention. The mean CQ score was 69.3 (SD=30.1) in the DRIFT group and 53.7 (SD=35.7) in the standard treatment group (unadjusted p=0.1; adjusted p=0.01, after adjustment for the prespecified variables sex, birth weight and IVH grade). Survival without severe cognitive disability was 66% in the DRIFT group and 35% in the standard treatment group (unadjusted p=0.019; adjusted p=0.003).
CONCLUSION


DRIFT is the first intervention for posthaemorrhagic ventricular dilatation to objectively demonstrate sustained cognitive improvement.
TRIAL REGISTRATION NUMBER


ISRCTN80286058.",2020,"Survival without severe cognitive disability was 66% in the DRIFT group and 35% in the standard treatment group (unadjusted p=0.019; adjusted p=0.003).
","['77 children randomised, 12 died, 2 could not be traced, 10 did not respond and 1 declined at 10-year follow-up', 'posthaemorrhagic ventricular dilatation', 'preterm infants', '77 preterm infants with IVH and progressive ventricular enlargement over specified measurements']","['Drainage, irrigation and fibrinolytic therapy (DRIFT', 'fibrinolytic followed by continuous lavage, until the drainage was clear, and standard care consisting of control of expansion by lumbar punctures and if expansion persisted via a ventricular access device']","['mean CQ score', 'severe cognitive impairment', 'Survival without severe cognitive disability', 'Cognitive quotient (CQ), derived from the British Ability Scales and Bayley III Scales, and survival without severe cognitive disability']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0442822', 'cui_str': 'Trace'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0591126', 'cui_str': 'AT-10'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C4552505', 'cui_str': 'PHVD'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0240059', 'cui_str': 'Ventricular hemorrhage'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C2675972', 'cui_str': 'Ventricular enlargement'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]","[{'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0040044', 'cui_str': 'Thrombolytic therapy'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0521097', 'cui_str': 'Cleared by'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0037943', 'cui_str': 'Lumbar puncture'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3554639', 'cui_str': 'Severe cognitive impairment'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0451042', 'cui_str': 'British ability scales'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",77.0,0.16837,"Survival without severe cognitive disability was 66% in the DRIFT group and 35% in the standard treatment group (unadjusted p=0.019; adjusted p=0.003).
","[{'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Luyt', 'Affiliation': 'Neonatal Neurology, Bristol Medical School, Faculty of Health Sciences, University of Bristol, Bristol, UK karen.luyt@bristol.ac.uk.'}, {'ForeName': 'Sally L', 'Initials': 'SL', 'LastName': 'Jary', 'Affiliation': 'Neonatal Neurology, Bristol Medical School, Faculty of Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Charlotte L', 'Initials': 'CL', 'LastName': 'Lea', 'Affiliation': 'Neonatal Neurology, Bristol Medical School, Faculty of Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Grace J', 'Initials': 'GJ', 'LastName': 'Young', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Odd', 'Affiliation': 'Neonatal Neurology, Bristol Medical School, Faculty of Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Helen E', 'Initials': 'HE', 'LastName': 'Miller', 'Affiliation': 'Neonatal Neurology, Bristol Medical School, Faculty of Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Grazyna', 'Initials': 'G', 'LastName': 'Kmita', 'Affiliation': 'Faculty of Psychology, University of Warsaw, Warszawa, Poland.'}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Williams', 'Affiliation': 'Ophthalmology, Bristol Eye Hospital, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Peter S', 'Initials': 'PS', 'LastName': 'Blair', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Hollingworth', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Morgan', 'Affiliation': ""Child Psychology, Community Children's Health Partnership, Bristol, UK.""}, {'ForeName': 'Adam P', 'Initials': 'AP', 'LastName': 'Smith-Collins', 'Affiliation': 'Neonatal Neurology, Bristol Medical School, Faculty of Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Walker-Cox', 'Affiliation': 'Neonatal Neurology, Bristol Medical School, Faculty of Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Aquilina', 'Affiliation': 'Department of Neurosurgery, Great Ormond Street Hospital for Children NHS Foundation Trust, London, UK.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Pople', 'Affiliation': 'Paediatric Neurosurgery, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Andrew G', 'Initials': 'AG', 'LastName': 'Whitelaw', 'Affiliation': 'Neonatal Neurology, Bristol Medical School, Faculty of Health Sciences, University of Bristol, Bristol, UK.'}]",Archives of disease in childhood. Fetal and neonatal edition,['10.1136/archdischild-2019-318231']
1260,32636425,Effect of nano-hydroxyapatite and ozone on approximal initial caries: a randomized clinical trial.,"The aim of the study was to assess the efficacy of three methods of enamel remineralization on initial approximal caries: (1) a nano-hydroxyapatite gel, (2) gaseous ozone therapy, (3) combination of a nano-hydroxyapatite gel and ozone. Patients (n = 92, age 20-30 years) with initial approximal enamel lesions on premolar and molar teeth (n = 546) were randomly allocated to three groups subjected to a 6-months treatment: Group I: domestic nano-hydroxyapatite remineralizing gel, group II: in-office ozone therapy, group III: both domestic remineralizing gel and ozone therapy. Caries lesions were assessed on bitewing radiographs at baseline, after 1 year and after 2 years. At one-year follow-up, the smallest rate of lesions with remineralisation (36.5%) was found in group I, and the highest (69.3%)-in group III. In group III a significant remineralisation was noticed in after 1 year and then a demineralisation after 2 years. Thus nano-hydroxyapatite gel and ozone therapy exert some capacities to remineralize approximal enamel and dentine subsurface lesions of premolar and molar teeth. Moreover, the combination of both methods produces the best effect compared to nano-hydroxyapatite or ozone therapy applied alone. However, the treatment should be continued for a long time in order to achieve nonrestorative recovery of caries.",2020,In group III a significant remineralisation was noticed in after 1 year and then a demineralisation after 2 years.,"['92, age 20-30 years) with initial approximal enamel lesions on premolar and molar teeth (n\u2009=\u2009546', 'approximal initial caries', 'Patients (n\u2009']","['domestic nano-hydroxyapatite remineralizing gel, group II: in-office ozone therapy, group III: both domestic remineralizing gel and ozone therapy', 'hydroxyapatite gel and ozone therapy', 'enamel remineralization', 'nano-hydroxyapatite gel, (2) gaseous ozone therapy, (3) combination of a nano-hydroxyapatite gel and ozone', 'nano-hydroxyapatite and ozone']","['smallest rate of lesions with remineralisation', 'initial approximal caries', 'Caries lesions']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0266858', 'cui_str': 'Incipient enamel caries'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0003063', 'cui_str': 'Domestic Animals'}, {'cui': 'C0020326', 'cui_str': 'Hydroxyapatite Derivatives'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C4727847', 'cui_str': 'Ozone therapy'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C0030106', 'cui_str': 'Ozone'}]","[{'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}]",546.0,0.0129443,In group III a significant remineralisation was noticed in after 1 year and then a demineralisation after 2 years.,"[{'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Grocholewicz', 'Affiliation': 'Department of Interdisciplinary Dentistry, Pomeranian Medical University, Al. Powstańców Wielkopolskich 72, 70-111, Szczecin, Poland. katarzyna.grocholewicz@pum.edu.pl.'}, {'ForeName': 'Grażyna', 'Initials': 'G', 'LastName': 'Matkowska-Cichocka', 'Affiliation': 'Department of Interdisciplinary Dentistry, Pomeranian Medical University, Al. Powstańców Wielkopolskich 72, 70-111, Szczecin, Poland.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Makowiecki', 'Affiliation': 'Department of General and Dental Radiology, Pomeranian Medical University, Al. Powstańców Wielkopolskich 72, 70-111, Szczecin, Poland.'}, {'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Droździk', 'Affiliation': 'Department of Interdisciplinary Dentistry, Pomeranian Medical University, Al. Powstańców Wielkopolskich 72, 70-111, Szczecin, Poland.'}, {'ForeName': 'Halina', 'Initials': 'H', 'LastName': 'Ey-Chmielewska', 'Affiliation': 'Department of Dental Prosthetics, Pomeranian Medical University, Al. Powstańców Wielkopolskich 72, 70-111, Szczecin, Poland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Dziewulska', 'Affiliation': 'Department of Interdisciplinary Dentistry, Pomeranian Medical University, Al. Powstańców Wielkopolskich 72, 70-111, Szczecin, Poland.'}, {'ForeName': 'Małgorzata', 'Initials': 'M', 'LastName': 'Tomasik', 'Affiliation': 'Department of Interdisciplinary Dentistry, Pomeranian Medical University, Al. Powstańców Wielkopolskich 72, 70-111, Szczecin, Poland.'}, {'ForeName': 'Grzegorz', 'Initials': 'G', 'LastName': 'Trybek', 'Affiliation': 'Department of Dental Surgery, Pomeranian Medical University, Al. Powstańców Wielkopolskich 72, 70-111, Szczecin, Poland.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Janiszewska-Olszowska', 'Affiliation': 'Department of Interdisciplinary Dentistry, Pomeranian Medical University, Al. Powstańców Wielkopolskich 72, 70-111, Szczecin, Poland.'}]",Scientific reports,['10.1038/s41598-020-67885-8']
1261,32638266,"Use, Persistence, Efficacy, and Safety of Apixaban in Patients with Non-Valvular Atrial Fibrillation in Unselected Patients in Germany. Results of the Prospective Apixaban in Atrial Fibrillation (APAF) Registry.","INTRODUCTION


Apixaban has been shown to be superior to warfarin in patients with non-valvular atrial fibrillation in the randomized ARISTOTLE trial and its use is recommended in current guidelines. There are only scarce data about its use, efficacy, and safety in unselected patients in Germany.
METHODS AND RESULTS


The APAF registry is a prospective non-interventional study enrolling 5015 patients with non-valvular atrial fibrillation. Of these, 1349 (26.9%) patients were initially treated with apixaban and followed up at 3 and 12 months. The dose of apixaban used was 1 × 2.5 mg in 1.6%, 2 × 2.5 mg in 30.4%, and 2 × 5 mg daily in 68.0% of patients, respectively. Inappropriate underdosing of apixaban was observed in 22.3%, mostly in elderly patients with higher HAS-BLED Score and a history of bleeding. Persistence to apixaban after 1 year was 88.6%, while the dose was changed in 3.7% of patients. Switching to other NOACs or VKAs occurred in 5.1%. After 12 months, all-cause mortality was 5.0%, non-fatal stroke occurred in 0.4%, non-fatal myocardial infarction in 0.6%, ISTH major bleeding in 0.8%, moderate or minor bleeding in 4.3% of patients, respectively.
CONCLUSIONS


In this prospective experience in unselected patients with atrial fibrillation, persistence to apixaban was high, and efficacy and safety were comparable to the results in clinical trials, supporting its use in clinical practice.",2020,"After 12 months, all-cause mortality was 5.0%, non-fatal stroke occurred in 0.4%, non-fatal myocardial infarction in 0.6%, ISTH major bleeding in 0.8%, moderate or minor bleeding in 4.3% of patients, respectively.
","['5015 patients with non-valvular atrial fibrillation', 'patients with non-valvular atrial fibrillation', 'Patients with Non-Valvular Atrial Fibrillation in Unselected Patients in Germany', 'unselected patients with atrial fibrillation', 'unselected patients in Germany']","['Apixaban', 'warfarin', 'apixaban']","['NOACs or VKAs', 'non-fatal stroke', 'Inappropriate underdosing of apixaban', 'ISTH major bleeding', 'cause mortality', 'non-fatal myocardial infarction', 'moderate or minor bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0017480', 'cui_str': 'Germany'}]","[{'cui': 'C1831808', 'cui_str': 'apixaban'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}]","[{'cui': 'C0642228', 'cui_str': 'N(4)-oleylcytosine arabinoside'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C3542467', 'cui_str': 'Inappropriate'}, {'cui': 'C1831808', 'cui_str': 'apixaban'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0026193', 'cui_str': 'Minor'}]",5015.0,0.0273181,"After 12 months, all-cause mortality was 5.0%, non-fatal stroke occurred in 0.4%, non-fatal myocardial infarction in 0.6%, ISTH major bleeding in 0.8%, moderate or minor bleeding in 4.3% of patients, respectively.
","[{'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Zeymer', 'Affiliation': 'Klinikum Ludwigshafen, Ludwigshafen, Germany. uwe.zeymer@t-online.de.'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Lober', 'Affiliation': 'Institut für Herzinfarktforschung Ludwigshafen, Ludwigshafen, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Wolf', 'Affiliation': 'Kardiologische Praxis, Stahnsdorf, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Richard', 'Affiliation': 'Praxis Dr. Richard, Erfurt, Germany.'}, {'ForeName': 'Heinrich', 'Initials': 'H', 'LastName': 'Schäfer', 'Affiliation': 'Praxis Dr. Schäfer, Herfurth, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Taggeselle', 'Affiliation': 'Praxis Markkleeberg, Markkleeberg, Germany.'}, {'ForeName': 'Hans-Joachim', 'Initials': 'HJ', 'LastName': 'Kabitz', 'Affiliation': 'Klinikum Konstanz, Konstanz, Germany.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Prondzinsky', 'Affiliation': 'Carl-Von-Basedow-Klinikum Merseburg, Merseburg, Germany.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Süselbeck', 'Affiliation': 'Kardiologische Praxisklinik Ludwigshafen, Ludwigshafen, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Cardiology and therapy,['10.1007/s40119-020-00188-1']
1262,32640755,A New Nasal Restriction Device Called FeelBreathe ®  Improves Breathing Patterns in Chronic Obstructive Pulmonary Disease Patients during Exercise.,"A device called FeelBreathe (FB) ®  was designed, developed, and patented for inspiratory muscle training. The main aim was to determine the acute responses on lung ventilation, gas exchange, and heart rate during exercise in patients with chronic obstructive pulmonary disease (COPD) with and without the use of FB. In this study, a randomized cross-over trial was performed with 18 men diagnosed with COPD (FEV 1  between 30% and 70% of its predicted value). Each participant randomly conducted two trials with 30 min of rest between them with the same protocol on a treadmill for 10 min at a constant rate of 50% of VO 2peak . Each test was performed randomly and in a crossover randomized design in two different conditions: (1) oronasal breathing; and (2) nasal breathing with FB (nasal ventilatory flow restriction device). It was observed that FB had positive effects on dynamic hyperinflation, breathing pattern, and breathing efficiency, with higher expiratory and inspiratory time. Despite these differences, blood oxygen saturation percentage, oxygen uptake, and heart rate showed a similar response for both conditions during exercise. The results suggest that exercise performed with FB improved ventilatory responses compared to the oronasal mode in COPD patients. This new tool could be used during most daily tasks and exercise programs.",2020,"Despite these differences, blood oxygen saturation percentage, oxygen uptake, and heart rate showed a similar response for both conditions during exercise.","['patients with chronic obstructive pulmonary disease (COPD) with and without the use of FB', '18 men diagnosed with COPD (FEV 1  between 30% and 70% of its predicted value', 'Chronic Obstructive Pulmonary Disease Patients during Exercise']","['Nasal Restriction Device Called FeelBreathe ®', 'oronasal breathing; and (2) nasal breathing with FB (nasal ventilatory flow restriction device']","['ventilatory responses', 'blood oxygen saturation percentage, oxygen uptake, and heart rate', 'acute responses on lung ventilation, gas exchange, and heart rate', 'dynamic hyperinflation, breathing pattern, and breathing efficiency, with higher expiratory and inspiratory time']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0587107', 'cui_str': 'During exercise'}]","[{'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C1720420', 'cui_str': 'Call'}]","[{'cui': 'C0428174', 'cui_str': 'Hemoglobin saturation with oxygen'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0554804', 'cui_str': 'Assisted breathing'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0020449', 'cui_str': 'Hyperdistention'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0428686', 'cui_str': 'Inspiratory time'}]",,0.10336,"Despite these differences, blood oxygen saturation percentage, oxygen uptake, and heart rate showed a similar response for both conditions during exercise.","[{'ForeName': 'José L', 'Initials': 'JL', 'LastName': 'Gonzalez-Montesinos', 'Affiliation': 'Department of Physical Education, Faculty of Education Sciences, University of Cádiz, 11519 Cádiz, Spain.'}, {'ForeName': 'Aurelio', 'Initials': 'A', 'LastName': 'Arnedillo', 'Affiliation': 'University Hospital Puerta del Mar. Pneumology, Allergy and Thoracic Surgery Department, 11009 Cádiz, Spain.'}, {'ForeName': 'Jorge R', 'Initials': 'JR', 'LastName': 'Fernandez-Santos', 'Affiliation': 'Biomedical Research and Innovation Institute of Cádiz (INiBICA) Research Unit, 11009 Cádiz, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Vaz-Pardal', 'Affiliation': 'Bahía Sur Andalusian Center for Sports Medicine, 11100 Cádiz, Spain.'}, {'ForeName': 'Pelayo A', 'Initials': 'PA', 'LastName': 'García', 'Affiliation': 'Center Sport Iberia, 29007 Málaga, Spain.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Castro-Piñero', 'Affiliation': 'Biomedical Research and Innovation Institute of Cádiz (INiBICA) Research Unit, 11009 Cádiz, Spain.'}, {'ForeName': 'Jesús G', 'Initials': 'JG', 'LastName': 'Ponce-González', 'Affiliation': 'Biomedical Research and Innovation Institute of Cádiz (INiBICA) Research Unit, 11009 Cádiz, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17134876']
1263,32643385,"Peer engagement in toddlers with autism: Community implementation of dyadic and individual Joint Attention, Symbolic Play, Engagement, and Regulation intervention.","LAY ABSTRACT


Although young children may participate in education and intervention programs that take place in classrooms or groups, there is little information about how toddlers with special needs, and specifically toddlers with autism, are engaging with their peers. This study takes place in a public center-based early intervention program for toddlers with autism. Classrooms of toddlers were randomly assigned to an individual social communication intervention or the same intervention adapted to include a peer. Children in both groups made gains in social communication and play skills. Children who had the peer intervention were more engaged with peers when an adult was present, but not when the children were unsupported. This article adds information about early skills that may be important for children to master so that they have more success when trying to interact with their peers. These skills include understanding language (referred to as ""receptive language"" at 12 months or more) and play skills including building and stacking (referred to as ""combination play""-for example, building with blocks or completing a puzzle) and extending familiar actions to themselves, others, and figures (referred to as ""presymbolic play""-for example, putting a bottle to the doll or to themselves). Understanding which skills to target can help practitioners focus their instruction to build children's skills toward connecting with peers through play.",2020,Classrooms of toddlers were randomly assigned to an individual social communication intervention or the same intervention adapted to include a peer.,"['Classrooms of toddlers', 'young children', 'toddlers with autism']",['individual social communication intervention or the same intervention adapted to include a peer'],['social communication and play skills'],"[{'cui': 'C0682053', 'cui_str': 'Toddler'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1274143', 'cui_str': 'Communication interventions'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0032214', 'cui_str': 'Play'}]",,0.0213406,Classrooms of toddlers were randomly assigned to an individual social communication intervention or the same intervention adapted to include a peer.,"[{'ForeName': 'Stephanie Y', 'Initials': 'SY', 'LastName': 'Shire', 'Affiliation': 'University of Oregon, USA.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Shih', 'Affiliation': 'University of California, Los Angeles, USA.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Bracaglia', 'Affiliation': 'New York Center for Child Development, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Kodjoe', 'Affiliation': 'New York Center for Child Development, USA.'}, {'ForeName': 'Connie', 'Initials': 'C', 'LastName': 'Kasari', 'Affiliation': 'University of California, Los Angeles, USA.'}]",Autism : the international journal of research and practice,['10.1177/1362361320935689']
1264,32645310,A Randomized Controlled Trial Comparing Subconjunctival Injection to Direct Scleral Application of Mitomycin C in Trabeculectomy.,"PURPOSE


To compare the efficacy of intraoperative scleral application with subconjunctival injection of mitomycin C (MMC) in trabeculectomy.
DESIGN


Prospective, randomized, interventional study.
METHODS


This study took place in a single clinical practice in an academic setting. Patients had medically uncontrolled glaucoma as indicated by high intraocular pressure (IOP), worsening visual field, or optic nerve head changes in whom primary trabeculectomy was indicated. Patients were older than 18 years with medically uncontrolled glaucoma and no history of incisional glaucoma surgery. Patients were randomized to MMC delivered by preoperative subconjunctival injection or by intraoperative direct scleral application using surgical sponges during trabeculectomy. Comprehensive eye examinations were conducted at 1 day, 1 week, 6 weeks, 3 months, and 6 months postoperatively. Subconjunctival 5-fluorouracil injections were given postoperatively, as needed. The primary outcome was the proportion of patients who demonstrated IOP of <21 mm Hg and ≥30% reduction in IOP from baseline. Secondary outcome measures included the number of IOP-lowering medications, bleb morphology using the Indiana Bleb Appearance Grading Scale, and complication rates.
RESULTS


Participants (n = 100) were randomized into groups matched for baseline demographics, glaucoma status, and baseline IOP. At 6 months, there were no significant differences between the injection (n = 38) and sponge (n = 40) groups in surgical success (P = .357), mean IOP (P = .707), number of glaucoma medications (P = 1.000), bleb height (P = .625), bleb extension (P = .216), bleb vascularity (P = .672), or complications rates.
CONCLUSION


Both techniques of MMC delivery (subconjunctival injection and direct scleral application) resulted in comparable surgical outcomes and bleb morphologies.",2020,"At six months, there were no significant differences between the injection (n = 38) and sponge (n = 40) group in surgical success (p = 0.357), mean IOP (p = 0.707), number of glaucoma medications (p = 1.000), bleb height (p = 0.625), bleb extension (p = 0.216), bleb vascularity (p = 0.672), or complications rates.
","['Participants (n=100', 'academic setting Patient or Study Population: Patients older than 18 years with medically uncontrolled glaucoma and no previous history of incisional glaucoma surgery Intervention or Observation Procedure(s): Subjects', 'Trabeculectomy', 'Subjects with medically uncontrolled glaucoma as indicated by high intraocular pressure (IOP), worsening visual field, or optic nerve head changes in whom primary trabeculectomy is indicated']","['Subconjunctival Injection', 'MMC delivery (subconjunctival injection and direct scleral application', 'mitomycin C (MMC', 'Subconjunctival 5-fluorouracil injections', 'preoperative subconjunctival injection or intraoperative direct scleral application using surgical sponges during trabeculectomy', 'Mitomycin C', 'MMC']","['number of glaucoma medications', 'bleb height', 'bleb vascularity', 'bleb extension', 'number of IOP lowering medications, bleb morphology using the Indiana Bleb Appearance Grading Scale, and complication rates', 'mean IOP', 'surgical success', 'surgical outcomes and bleb morphologies']","[{'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0197489', 'cui_str': 'Operation for glaucoma'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0040574', 'cui_str': 'Trabeculoplasty'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0234708', 'cui_str': 'Raised intraocular pressure'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0042826', 'cui_str': 'Visual field'}, {'cui': 'C0029127', 'cui_str': 'Optic disc structure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]","[{'cui': 'C0197180', 'cui_str': 'Subconjunctival injection'}, {'cui': 'C0002475', 'cui_str': 'Mitomycin'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0442183', 'cui_str': 'Subconjunctival'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0038937', 'cui_str': 'Surgical sponge'}, {'cui': 'C0040574', 'cui_str': 'Trabeculoplasty'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0005758', 'cui_str': 'Blister'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}, {'cui': 'C0021206', 'cui_str': 'Indiana'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",100.0,0.153502,"At six months, there were no significant differences between the injection (n = 38) and sponge (n = 40) group in surgical success (p = 0.357), mean IOP (p = 0.707), number of glaucoma medications (p = 1.000), bleb height (p = 0.625), bleb extension (p = 0.216), bleb vascularity (p = 0.672), or complications rates.
","[{'ForeName': 'Jiun L', 'Initials': 'JL', 'LastName': 'Do', 'Affiliation': 'Hamilton Glaucoma Center, Shiley Eye Institute and Viterbi Family Department of Ophthalmology, University of California, San Diego, California, USA.'}, {'ForeName': 'Benjamin Y', 'Initials': 'BY', 'LastName': 'Xu', 'Affiliation': 'USC Roski Eye Institute, Department of Ophthalmology, Keck School of Medicine at the University of Southern California, Los Angeles, California, USA.'}, {'ForeName': 'Brandon', 'Initials': 'B', 'LastName': 'Wong', 'Affiliation': 'USC Roski Eye Institute, Department of Ophthalmology, Keck School of Medicine at the University of Southern California, Los Angeles, California, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Camp', 'Affiliation': 'Hamilton Glaucoma Center, Shiley Eye Institute and Viterbi Family Department of Ophthalmology, University of California, San Diego, California, USA.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Ngai', 'Affiliation': 'Hamilton Glaucoma Center, Shiley Eye Institute and Viterbi Family Department of Ophthalmology, University of California, San Diego, California, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Long', 'Affiliation': 'Hamilton Glaucoma Center, Shiley Eye Institute and Viterbi Family Department of Ophthalmology, University of California, San Diego, California, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Proudfoot', 'Affiliation': 'Hamilton Glaucoma Center, Shiley Eye Institute and Viterbi Family Department of Ophthalmology, University of California, San Diego, California, USA.'}, {'ForeName': 'Sasan', 'Initials': 'S', 'LastName': 'Moghimi', 'Affiliation': 'Hamilton Glaucoma Center, Shiley Eye Institute and Viterbi Family Department of Ophthalmology, University of California, San Diego, California, USA.'}, {'ForeName': 'Diya', 'Initials': 'D', 'LastName': 'Yan', 'Affiliation': 'Hamilton Glaucoma Center, Shiley Eye Institute and Viterbi Family Department of Ophthalmology, University of California, San Diego, California, USA.'}, {'ForeName': 'Derek S', 'Initials': 'DS', 'LastName': 'Welsbie', 'Affiliation': 'Hamilton Glaucoma Center, Shiley Eye Institute and Viterbi Family Department of Ophthalmology, University of California, San Diego, California, USA.'}, {'ForeName': 'Robert N', 'Initials': 'RN', 'LastName': 'Weinreb', 'Affiliation': 'Hamilton Glaucoma Center, Shiley Eye Institute and Viterbi Family Department of Ophthalmology, University of California, San Diego, California, USA. Electronic address: rweinreb@health.ucsd.edu.'}]",American journal of ophthalmology,['10.1016/j.ajo.2020.07.002']
1265,32651286,"A randomized, placebo-controlled, phase 2 trial of laquinimod in primary progressive multiple sclerosis.","OBJECTIVE


To evaluate efficacy, safety, and tolerability of laquinimod in patients with primary progressive multiple sclerosis (PPMS).
METHODS


In the randomized, double-blind, placebo-controlled, phase 2 study, ARPEGGIO (A Randomized Placebo-controlled Trial Evaluating Laquinimod in PPMS, Gauging Gradations in MRI and Clinical Outcomes), eligible patients with PPMS were randomized 1:1:1 to receive once-daily oral laquinimod 0.6 mg or 1.5 mg or matching placebo. Percentage brain volume change (PBVC; primary endpoint) from baseline to week 48 was assessed by MRI. Secondary and exploratory endpoints included clinical and MRI measures. Efficacy endpoints were evaluated using a predefined, hierarchical statistical testing procedure. Safety was monitored throughout the study. The laquinimod 1.5 mg dose arm was discontinued on January 1, 2016, due to findings of cardiovascular events.
RESULTS


A total of 374 patients were randomized to laquinimod 0.6 mg (n = 139) or 1.5 mg (n = 95) or placebo (n = 140). ARPEGGIO did not meet the primary endpoint of significant treatment effect with laquinimod 0.6 mg vs placebo on PBVC from baseline to week 48 (adjusted mean difference = 0.016%,  p  = 0.903). Laquinimod 0.6 mg reduced the number of new T2 brain lesions at week 48 (risk ratio 0.4; 95% confidence interval, 0.26-0.69;  p  = 0.001). Incidence of adverse events was higher among patients treated with laquinimod 0.6 mg (83%) vs laquinimod 1.5 mg (66%) and placebo (78%).
CONCLUSIONS


Laquinimod 0.6 mg did not demonstrate a statistically significant effect on brain volume loss in PPMS at week 48.
CLINICALTRIALSGOV IDENTIFIER


NCT02284568.
CLASSIFICATION OF EVIDENCE


This study provides Class I evidence that, although well tolerated, laquinimod 0.6 mg did not demonstrate a significant treatment effect on PBVC in patients with PPMS.",2020,"Laquinimod 0.6 mg reduced the number of new T2 brain lesions at week 48 (risk ratio = 0.4; 95% confidence interval, 0.26-0.69;  p  = 0.001).","['primary progressive multiple sclerosis', 'patients with primary progressive multiple sclerosis (PPMS', '374 patients', 'eligible PPMS patients']","['Placebo', 'laquinimod 0.6 mg or 1.5 mg or matching placebo', 'Laquinimod', 'laquinimod', 'placebo']","['Safety', 'number of new T2 brain lesions', 'clinical and MRI measures', 'brain volume loss', 'Percentage brain volume change (PBVC', 'efficacy, safety, and tolerability', 'Incidence of adverse events', 'PBVC']","[{'cui': 'C0751964', 'cui_str': 'Primary progressive multiple sclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1260208', 'cui_str': 'laquinimod'}, {'cui': 'C4068883', 'cui_str': '0.6'}, {'cui': 'C3844012', 'cui_str': '1.5'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0221505', 'cui_str': 'Lesion of brain'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",374.0,0.695841,"Laquinimod 0.6 mg reduced the number of new T2 brain lesions at week 48 (risk ratio = 0.4; 95% confidence interval, 0.26-0.69;  p  = 0.001).","[{'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Giovannoni', 'Affiliation': ""From Barts and The London School of Medicine and Dentistry (G.G.), Blizard Institute, Queen Mary University of London, UK; Teva Pharmaceuticals R&D (V.K.), Teva Pharmaceutical Industries (T.L.), Great Valley, PA; Department of Neurology, Medical Faculty (V.K., H.-P.H.), Heinrich-Heine Universität Düsseldorf, Germany; Teva Pharmaceutical Industries (J.R.S., A.P.T.), Malvern, PA; Corinne Goldsmith Dickinson Center for Multiple Sclerosis (S.K.) and Neurology (F.L.), Icahn School of Medicine at Mount Sinai, New York, NY; Departments of Neuroscience, Rehabilitation, Ophthalmology, Genetics, and Maternal and Child Health and Center of Excellence for Biomedical Research (A.U.) and Department of Health Sciences (M.P.S.), University of Genoa; Ospedale Policlinico San Martino-IRCCS (A.U.), Genoa, Italy; Department of Neurology (B.M.J.U.), MS Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, the Netherlands; Division of Neurology (X.M.), University of Toronto/MS Centre St Michael's Hospital, Canada; Neurology-Neuroimmunology Department and Neurorehabilitation Unit (X.M.), Multiple Sclerosis Centre of Catalonia; Department of Neurology (X.M.), Hospital Universitari de la Vall d'Hebron, Barcelona, Spain; Weill Institute for Neurosciences (B.A.C.C.), Department of Neurology, University of California San Francisco; Radiology & Nuclear Medicine (F.L.), VU University Medical Center, Amsterdam, the Netherlands; and UCL Institutes of Neurology and Healthcare Engineering (F.B.), London, UK. g.giovannoni@qmul.ac.uk.""}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Knappertz', 'Affiliation': ""From Barts and The London School of Medicine and Dentistry (G.G.), Blizard Institute, Queen Mary University of London, UK; Teva Pharmaceuticals R&D (V.K.), Teva Pharmaceutical Industries (T.L.), Great Valley, PA; Department of Neurology, Medical Faculty (V.K., H.-P.H.), Heinrich-Heine Universität Düsseldorf, Germany; Teva Pharmaceutical Industries (J.R.S., A.P.T.), Malvern, PA; Corinne Goldsmith Dickinson Center for Multiple Sclerosis (S.K.) and Neurology (F.L.), Icahn School of Medicine at Mount Sinai, New York, NY; Departments of Neuroscience, Rehabilitation, Ophthalmology, Genetics, and Maternal and Child Health and Center of Excellence for Biomedical Research (A.U.) and Department of Health Sciences (M.P.S.), University of Genoa; Ospedale Policlinico San Martino-IRCCS (A.U.), Genoa, Italy; Department of Neurology (B.M.J.U.), MS Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, the Netherlands; Division of Neurology (X.M.), University of Toronto/MS Centre St Michael's Hospital, Canada; Neurology-Neuroimmunology Department and Neurorehabilitation Unit (X.M.), Multiple Sclerosis Centre of Catalonia; Department of Neurology (X.M.), Hospital Universitari de la Vall d'Hebron, Barcelona, Spain; Weill Institute for Neurosciences (B.A.C.C.), Department of Neurology, University of California San Francisco; Radiology & Nuclear Medicine (F.L.), VU University Medical Center, Amsterdam, the Netherlands; and UCL Institutes of Neurology and Healthcare Engineering (F.B.), London, UK.""}, {'ForeName': 'Joshua R', 'Initials': 'JR', 'LastName': 'Steinerman', 'Affiliation': ""From Barts and The London School of Medicine and Dentistry (G.G.), Blizard Institute, Queen Mary University of London, UK; Teva Pharmaceuticals R&D (V.K.), Teva Pharmaceutical Industries (T.L.), Great Valley, PA; Department of Neurology, Medical Faculty (V.K., H.-P.H.), Heinrich-Heine Universität Düsseldorf, Germany; Teva Pharmaceutical Industries (J.R.S., A.P.T.), Malvern, PA; Corinne Goldsmith Dickinson Center for Multiple Sclerosis (S.K.) and Neurology (F.L.), Icahn School of Medicine at Mount Sinai, New York, NY; Departments of Neuroscience, Rehabilitation, Ophthalmology, Genetics, and Maternal and Child Health and Center of Excellence for Biomedical Research (A.U.) and Department of Health Sciences (M.P.S.), University of Genoa; Ospedale Policlinico San Martino-IRCCS (A.U.), Genoa, Italy; Department of Neurology (B.M.J.U.), MS Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, the Netherlands; Division of Neurology (X.M.), University of Toronto/MS Centre St Michael's Hospital, Canada; Neurology-Neuroimmunology Department and Neurorehabilitation Unit (X.M.), Multiple Sclerosis Centre of Catalonia; Department of Neurology (X.M.), Hospital Universitari de la Vall d'Hebron, Barcelona, Spain; Weill Institute for Neurosciences (B.A.C.C.), Department of Neurology, University of California San Francisco; Radiology & Nuclear Medicine (F.L.), VU University Medical Center, Amsterdam, the Netherlands; and UCL Institutes of Neurology and Healthcare Engineering (F.B.), London, UK.""}, {'ForeName': 'Aaron P', 'Initials': 'AP', 'LastName': 'Tansy', 'Affiliation': ""From Barts and The London School of Medicine and Dentistry (G.G.), Blizard Institute, Queen Mary University of London, UK; Teva Pharmaceuticals R&D (V.K.), Teva Pharmaceutical Industries (T.L.), Great Valley, PA; Department of Neurology, Medical Faculty (V.K., H.-P.H.), Heinrich-Heine Universität Düsseldorf, Germany; Teva Pharmaceutical Industries (J.R.S., A.P.T.), Malvern, PA; Corinne Goldsmith Dickinson Center for Multiple Sclerosis (S.K.) and Neurology (F.L.), Icahn School of Medicine at Mount Sinai, New York, NY; Departments of Neuroscience, Rehabilitation, Ophthalmology, Genetics, and Maternal and Child Health and Center of Excellence for Biomedical Research (A.U.) and Department of Health Sciences (M.P.S.), University of Genoa; Ospedale Policlinico San Martino-IRCCS (A.U.), Genoa, Italy; Department of Neurology (B.M.J.U.), MS Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, the Netherlands; Division of Neurology (X.M.), University of Toronto/MS Centre St Michael's Hospital, Canada; Neurology-Neuroimmunology Department and Neurorehabilitation Unit (X.M.), Multiple Sclerosis Centre of Catalonia; Department of Neurology (X.M.), Hospital Universitari de la Vall d'Hebron, Barcelona, Spain; Weill Institute for Neurosciences (B.A.C.C.), Department of Neurology, University of California San Francisco; Radiology & Nuclear Medicine (F.L.), VU University Medical Center, Amsterdam, the Netherlands; and UCL Institutes of Neurology and Healthcare Engineering (F.B.), London, UK.""}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': ""From Barts and The London School of Medicine and Dentistry (G.G.), Blizard Institute, Queen Mary University of London, UK; Teva Pharmaceuticals R&D (V.K.), Teva Pharmaceutical Industries (T.L.), Great Valley, PA; Department of Neurology, Medical Faculty (V.K., H.-P.H.), Heinrich-Heine Universität Düsseldorf, Germany; Teva Pharmaceutical Industries (J.R.S., A.P.T.), Malvern, PA; Corinne Goldsmith Dickinson Center for Multiple Sclerosis (S.K.) and Neurology (F.L.), Icahn School of Medicine at Mount Sinai, New York, NY; Departments of Neuroscience, Rehabilitation, Ophthalmology, Genetics, and Maternal and Child Health and Center of Excellence for Biomedical Research (A.U.) and Department of Health Sciences (M.P.S.), University of Genoa; Ospedale Policlinico San Martino-IRCCS (A.U.), Genoa, Italy; Department of Neurology (B.M.J.U.), MS Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, the Netherlands; Division of Neurology (X.M.), University of Toronto/MS Centre St Michael's Hospital, Canada; Neurology-Neuroimmunology Department and Neurorehabilitation Unit (X.M.), Multiple Sclerosis Centre of Catalonia; Department of Neurology (X.M.), Hospital Universitari de la Vall d'Hebron, Barcelona, Spain; Weill Institute for Neurosciences (B.A.C.C.), Department of Neurology, University of California San Francisco; Radiology & Nuclear Medicine (F.L.), VU University Medical Center, Amsterdam, the Netherlands; and UCL Institutes of Neurology and Healthcare Engineering (F.B.), London, UK.""}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Krieger', 'Affiliation': ""From Barts and The London School of Medicine and Dentistry (G.G.), Blizard Institute, Queen Mary University of London, UK; Teva Pharmaceuticals R&D (V.K.), Teva Pharmaceutical Industries (T.L.), Great Valley, PA; Department of Neurology, Medical Faculty (V.K., H.-P.H.), Heinrich-Heine Universität Düsseldorf, Germany; Teva Pharmaceutical Industries (J.R.S., A.P.T.), Malvern, PA; Corinne Goldsmith Dickinson Center for Multiple Sclerosis (S.K.) and Neurology (F.L.), Icahn School of Medicine at Mount Sinai, New York, NY; Departments of Neuroscience, Rehabilitation, Ophthalmology, Genetics, and Maternal and Child Health and Center of Excellence for Biomedical Research (A.U.) and Department of Health Sciences (M.P.S.), University of Genoa; Ospedale Policlinico San Martino-IRCCS (A.U.), Genoa, Italy; Department of Neurology (B.M.J.U.), MS Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, the Netherlands; Division of Neurology (X.M.), University of Toronto/MS Centre St Michael's Hospital, Canada; Neurology-Neuroimmunology Department and Neurorehabilitation Unit (X.M.), Multiple Sclerosis Centre of Catalonia; Department of Neurology (X.M.), Hospital Universitari de la Vall d'Hebron, Barcelona, Spain; Weill Institute for Neurosciences (B.A.C.C.), Department of Neurology, University of California San Francisco; Radiology & Nuclear Medicine (F.L.), VU University Medical Center, Amsterdam, the Netherlands; and UCL Institutes of Neurology and Healthcare Engineering (F.B.), London, UK.""}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Uccelli', 'Affiliation': ""From Barts and The London School of Medicine and Dentistry (G.G.), Blizard Institute, Queen Mary University of London, UK; Teva Pharmaceuticals R&D (V.K.), Teva Pharmaceutical Industries (T.L.), Great Valley, PA; Department of Neurology, Medical Faculty (V.K., H.-P.H.), Heinrich-Heine Universität Düsseldorf, Germany; Teva Pharmaceutical Industries (J.R.S., A.P.T.), Malvern, PA; Corinne Goldsmith Dickinson Center for Multiple Sclerosis (S.K.) and Neurology (F.L.), Icahn School of Medicine at Mount Sinai, New York, NY; Departments of Neuroscience, Rehabilitation, Ophthalmology, Genetics, and Maternal and Child Health and Center of Excellence for Biomedical Research (A.U.) and Department of Health Sciences (M.P.S.), University of Genoa; Ospedale Policlinico San Martino-IRCCS (A.U.), Genoa, Italy; Department of Neurology (B.M.J.U.), MS Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, the Netherlands; Division of Neurology (X.M.), University of Toronto/MS Centre St Michael's Hospital, Canada; Neurology-Neuroimmunology Department and Neurorehabilitation Unit (X.M.), Multiple Sclerosis Centre of Catalonia; Department of Neurology (X.M.), Hospital Universitari de la Vall d'Hebron, Barcelona, Spain; Weill Institute for Neurosciences (B.A.C.C.), Department of Neurology, University of California San Francisco; Radiology & Nuclear Medicine (F.L.), VU University Medical Center, Amsterdam, the Netherlands; and UCL Institutes of Neurology and Healthcare Engineering (F.B.), London, UK.""}, {'ForeName': 'Bernard M J', 'Initials': 'BMJ', 'LastName': 'Uitdehaag', 'Affiliation': ""From Barts and The London School of Medicine and Dentistry (G.G.), Blizard Institute, Queen Mary University of London, UK; Teva Pharmaceuticals R&D (V.K.), Teva Pharmaceutical Industries (T.L.), Great Valley, PA; Department of Neurology, Medical Faculty (V.K., H.-P.H.), Heinrich-Heine Universität Düsseldorf, Germany; Teva Pharmaceutical Industries (J.R.S., A.P.T.), Malvern, PA; Corinne Goldsmith Dickinson Center for Multiple Sclerosis (S.K.) and Neurology (F.L.), Icahn School of Medicine at Mount Sinai, New York, NY; Departments of Neuroscience, Rehabilitation, Ophthalmology, Genetics, and Maternal and Child Health and Center of Excellence for Biomedical Research (A.U.) and Department of Health Sciences (M.P.S.), University of Genoa; Ospedale Policlinico San Martino-IRCCS (A.U.), Genoa, Italy; Department of Neurology (B.M.J.U.), MS Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, the Netherlands; Division of Neurology (X.M.), University of Toronto/MS Centre St Michael's Hospital, Canada; Neurology-Neuroimmunology Department and Neurorehabilitation Unit (X.M.), Multiple Sclerosis Centre of Catalonia; Department of Neurology (X.M.), Hospital Universitari de la Vall d'Hebron, Barcelona, Spain; Weill Institute for Neurosciences (B.A.C.C.), Department of Neurology, University of California San Francisco; Radiology & Nuclear Medicine (F.L.), VU University Medical Center, Amsterdam, the Netherlands; and UCL Institutes of Neurology and Healthcare Engineering (F.B.), London, UK.""}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Montalban', 'Affiliation': ""From Barts and The London School of Medicine and Dentistry (G.G.), Blizard Institute, Queen Mary University of London, UK; Teva Pharmaceuticals R&D (V.K.), Teva Pharmaceutical Industries (T.L.), Great Valley, PA; Department of Neurology, Medical Faculty (V.K., H.-P.H.), Heinrich-Heine Universität Düsseldorf, Germany; Teva Pharmaceutical Industries (J.R.S., A.P.T.), Malvern, PA; Corinne Goldsmith Dickinson Center for Multiple Sclerosis (S.K.) and Neurology (F.L.), Icahn School of Medicine at Mount Sinai, New York, NY; Departments of Neuroscience, Rehabilitation, Ophthalmology, Genetics, and Maternal and Child Health and Center of Excellence for Biomedical Research (A.U.) and Department of Health Sciences (M.P.S.), University of Genoa; Ospedale Policlinico San Martino-IRCCS (A.U.), Genoa, Italy; Department of Neurology (B.M.J.U.), MS Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, the Netherlands; Division of Neurology (X.M.), University of Toronto/MS Centre St Michael's Hospital, Canada; Neurology-Neuroimmunology Department and Neurorehabilitation Unit (X.M.), Multiple Sclerosis Centre of Catalonia; Department of Neurology (X.M.), Hospital Universitari de la Vall d'Hebron, Barcelona, Spain; Weill Institute for Neurosciences (B.A.C.C.), Department of Neurology, University of California San Francisco; Radiology & Nuclear Medicine (F.L.), VU University Medical Center, Amsterdam, the Netherlands; and UCL Institutes of Neurology and Healthcare Engineering (F.B.), London, UK.""}, {'ForeName': 'Hans-Peter', 'Initials': 'HP', 'LastName': 'Hartung', 'Affiliation': ""From Barts and The London School of Medicine and Dentistry (G.G.), Blizard Institute, Queen Mary University of London, UK; Teva Pharmaceuticals R&D (V.K.), Teva Pharmaceutical Industries (T.L.), Great Valley, PA; Department of Neurology, Medical Faculty (V.K., H.-P.H.), Heinrich-Heine Universität Düsseldorf, Germany; Teva Pharmaceutical Industries (J.R.S., A.P.T.), Malvern, PA; Corinne Goldsmith Dickinson Center for Multiple Sclerosis (S.K.) and Neurology (F.L.), Icahn School of Medicine at Mount Sinai, New York, NY; Departments of Neuroscience, Rehabilitation, Ophthalmology, Genetics, and Maternal and Child Health and Center of Excellence for Biomedical Research (A.U.) and Department of Health Sciences (M.P.S.), University of Genoa; Ospedale Policlinico San Martino-IRCCS (A.U.), Genoa, Italy; Department of Neurology (B.M.J.U.), MS Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, the Netherlands; Division of Neurology (X.M.), University of Toronto/MS Centre St Michael's Hospital, Canada; Neurology-Neuroimmunology Department and Neurorehabilitation Unit (X.M.), Multiple Sclerosis Centre of Catalonia; Department of Neurology (X.M.), Hospital Universitari de la Vall d'Hebron, Barcelona, Spain; Weill Institute for Neurosciences (B.A.C.C.), Department of Neurology, University of California San Francisco; Radiology & Nuclear Medicine (F.L.), VU University Medical Center, Amsterdam, the Netherlands; and UCL Institutes of Neurology and Healthcare Engineering (F.B.), London, UK.""}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Pia Sormani', 'Affiliation': ""From Barts and The London School of Medicine and Dentistry (G.G.), Blizard Institute, Queen Mary University of London, UK; Teva Pharmaceuticals R&D (V.K.), Teva Pharmaceutical Industries (T.L.), Great Valley, PA; Department of Neurology, Medical Faculty (V.K., H.-P.H.), Heinrich-Heine Universität Düsseldorf, Germany; Teva Pharmaceutical Industries (J.R.S., A.P.T.), Malvern, PA; Corinne Goldsmith Dickinson Center for Multiple Sclerosis (S.K.) and Neurology (F.L.), Icahn School of Medicine at Mount Sinai, New York, NY; Departments of Neuroscience, Rehabilitation, Ophthalmology, Genetics, and Maternal and Child Health and Center of Excellence for Biomedical Research (A.U.) and Department of Health Sciences (M.P.S.), University of Genoa; Ospedale Policlinico San Martino-IRCCS (A.U.), Genoa, Italy; Department of Neurology (B.M.J.U.), MS Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, the Netherlands; Division of Neurology (X.M.), University of Toronto/MS Centre St Michael's Hospital, Canada; Neurology-Neuroimmunology Department and Neurorehabilitation Unit (X.M.), Multiple Sclerosis Centre of Catalonia; Department of Neurology (X.M.), Hospital Universitari de la Vall d'Hebron, Barcelona, Spain; Weill Institute for Neurosciences (B.A.C.C.), Department of Neurology, University of California San Francisco; Radiology & Nuclear Medicine (F.L.), VU University Medical Center, Amsterdam, the Netherlands; and UCL Institutes of Neurology and Healthcare Engineering (F.B.), London, UK.""}, {'ForeName': 'Bruce A C', 'Initials': 'BAC', 'LastName': 'Cree', 'Affiliation': ""From Barts and The London School of Medicine and Dentistry (G.G.), Blizard Institute, Queen Mary University of London, UK; Teva Pharmaceuticals R&D (V.K.), Teva Pharmaceutical Industries (T.L.), Great Valley, PA; Department of Neurology, Medical Faculty (V.K., H.-P.H.), Heinrich-Heine Universität Düsseldorf, Germany; Teva Pharmaceutical Industries (J.R.S., A.P.T.), Malvern, PA; Corinne Goldsmith Dickinson Center for Multiple Sclerosis (S.K.) and Neurology (F.L.), Icahn School of Medicine at Mount Sinai, New York, NY; Departments of Neuroscience, Rehabilitation, Ophthalmology, Genetics, and Maternal and Child Health and Center of Excellence for Biomedical Research (A.U.) and Department of Health Sciences (M.P.S.), University of Genoa; Ospedale Policlinico San Martino-IRCCS (A.U.), Genoa, Italy; Department of Neurology (B.M.J.U.), MS Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, the Netherlands; Division of Neurology (X.M.), University of Toronto/MS Centre St Michael's Hospital, Canada; Neurology-Neuroimmunology Department and Neurorehabilitation Unit (X.M.), Multiple Sclerosis Centre of Catalonia; Department of Neurology (X.M.), Hospital Universitari de la Vall d'Hebron, Barcelona, Spain; Weill Institute for Neurosciences (B.A.C.C.), Department of Neurology, University of California San Francisco; Radiology & Nuclear Medicine (F.L.), VU University Medical Center, Amsterdam, the Netherlands; and UCL Institutes of Neurology and Healthcare Engineering (F.B.), London, UK.""}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Lublin', 'Affiliation': ""From Barts and The London School of Medicine and Dentistry (G.G.), Blizard Institute, Queen Mary University of London, UK; Teva Pharmaceuticals R&D (V.K.), Teva Pharmaceutical Industries (T.L.), Great Valley, PA; Department of Neurology, Medical Faculty (V.K., H.-P.H.), Heinrich-Heine Universität Düsseldorf, Germany; Teva Pharmaceutical Industries (J.R.S., A.P.T.), Malvern, PA; Corinne Goldsmith Dickinson Center for Multiple Sclerosis (S.K.) and Neurology (F.L.), Icahn School of Medicine at Mount Sinai, New York, NY; Departments of Neuroscience, Rehabilitation, Ophthalmology, Genetics, and Maternal and Child Health and Center of Excellence for Biomedical Research (A.U.) and Department of Health Sciences (M.P.S.), University of Genoa; Ospedale Policlinico San Martino-IRCCS (A.U.), Genoa, Italy; Department of Neurology (B.M.J.U.), MS Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, the Netherlands; Division of Neurology (X.M.), University of Toronto/MS Centre St Michael's Hospital, Canada; Neurology-Neuroimmunology Department and Neurorehabilitation Unit (X.M.), Multiple Sclerosis Centre of Catalonia; Department of Neurology (X.M.), Hospital Universitari de la Vall d'Hebron, Barcelona, Spain; Weill Institute for Neurosciences (B.A.C.C.), Department of Neurology, University of California San Francisco; Radiology & Nuclear Medicine (F.L.), VU University Medical Center, Amsterdam, the Netherlands; and UCL Institutes of Neurology and Healthcare Engineering (F.B.), London, UK.""}, {'ForeName': 'Frederik', 'Initials': 'F', 'LastName': 'Barkhof', 'Affiliation': ""From Barts and The London School of Medicine and Dentistry (G.G.), Blizard Institute, Queen Mary University of London, UK; Teva Pharmaceuticals R&D (V.K.), Teva Pharmaceutical Industries (T.L.), Great Valley, PA; Department of Neurology, Medical Faculty (V.K., H.-P.H.), Heinrich-Heine Universität Düsseldorf, Germany; Teva Pharmaceutical Industries (J.R.S., A.P.T.), Malvern, PA; Corinne Goldsmith Dickinson Center for Multiple Sclerosis (S.K.) and Neurology (F.L.), Icahn School of Medicine at Mount Sinai, New York, NY; Departments of Neuroscience, Rehabilitation, Ophthalmology, Genetics, and Maternal and Child Health and Center of Excellence for Biomedical Research (A.U.) and Department of Health Sciences (M.P.S.), University of Genoa; Ospedale Policlinico San Martino-IRCCS (A.U.), Genoa, Italy; Department of Neurology (B.M.J.U.), MS Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, the Netherlands; Division of Neurology (X.M.), University of Toronto/MS Centre St Michael's Hospital, Canada; Neurology-Neuroimmunology Department and Neurorehabilitation Unit (X.M.), Multiple Sclerosis Centre of Catalonia; Department of Neurology (X.M.), Hospital Universitari de la Vall d'Hebron, Barcelona, Spain; Weill Institute for Neurosciences (B.A.C.C.), Department of Neurology, University of California San Francisco; Radiology & Nuclear Medicine (F.L.), VU University Medical Center, Amsterdam, the Netherlands; and UCL Institutes of Neurology and Healthcare Engineering (F.B.), London, UK.""}]",Neurology,['10.1212/WNL.0000000000010284']
1266,32621102,The use of doxazosin before adrenalectomy for pheochromocytoma: is the duration related to intraoperative hemodynamics and postoperative complications?,"PURPOSE


No conclusion exists for the optimum duration of preoperative administration of doxazosin (DOX) before adrenalectomy for pheochromocytoma. The purpose of this study is to investigate whether perioperative hemodynamics and postoperative outcomes are related to the duration of DOX administration.
METHODS


In total, 132 patients managed preoperatively with single α-receptor blocker DOX were enrolled. All patients underwent adrenalectomy for pheochromocytoma in the Department of Urology, Peking University First Hospital, between January 2001 and July 2019. Patients were divided into three groups based on the duration of preoperative administration of DOX: group A (≤14 days), group B (15-30 days), and group C (>30 days). Patient and tumor characteristics, intraoperative hemodynamics, and postoperative outcomes were recorded and compared.
RESULTS


These patients included 57 men and 75 women, with an average age of 48 years. Clinical characteristics, preoperative hemodynamics, medicine management and surgical approaches were comparable between the three groups. Among the three groups, we found that group C (>30 days) had the lowest intraoperative minimum heart rate [group A vs. group B vs. group C = 60 (52-67) vs. 59 (50-61) vs. 51.5 (50-58.75), p = 0.024] and highest risk of postoperative hypotension requiring vasopressor support [group A vs. group B vs. group C = 14 (20.3%) vs. 12 (27.9%) vs. 10 (50.0%), p = 0.032].
CONCLUSION


The current study indicated that preoperative management of pheochromocytoma with single α-receptor blocker DOX for more than 30 days after final dose adjustment might lead to intraoperative bradycardia and more postoperative hypotension requiring vasopressor support. Thus, our study does not support long-term (over 30 days) preoperative administration of pheochromocytoma with single α-receptor blocker DOX in the final dose.",2020,"Clinical characteristics, preoperative hemodynamics, medicine management and surgical approaches were comparable between the three groups.","['patients included 57 men and 75 women, with an average age of 48\xa0years', '132 patients managed preoperatively with single α-receptor blocker DOX were enrolled', 'pheochromocytoma', 'All patients underwent adrenalectomy for pheochromocytoma in the Department of Urology, Peking University First Hospital, between January 2001 and July 2019']","['doxazosin (DOX', 'pheochromocytoma with single α-receptor blocker DOX', 'doxazosin', 'DOX']","['Patient and tumor characteristics, intraoperative hemodynamics, and postoperative outcomes', 'highest risk of postoperative hypotension requiring vasopressor support', 'lowest intraoperative minimum heart rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0114873', 'cui_str': 'Doxazosin'}, {'cui': 'C0031511', 'cui_str': 'Chromaffinoma'}, {'cui': 'C0001632', 'cui_str': 'Adrenalectomy'}, {'cui': 'C0042077', 'cui_str': 'Urology'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0114873', 'cui_str': 'Doxazosin'}, {'cui': 'C0031511', 'cui_str': 'Chromaffinoma'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0865752', 'cui_str': 'Postoperative hypotension'}, {'cui': 'C0042397', 'cui_str': 'Vasoconstrictor agent'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",132.0,0.0332186,"Clinical characteristics, preoperative hemodynamics, medicine management and surgical approaches were comparable between the three groups.","[{'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Kong', 'Affiliation': 'Department of Anaesthesiology and Critical Care Medicine, Peking University First Hospital, No. 8 Xishiku Street, Xicheng District, Beijing, 100034, China.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'Department of Anaesthesiology and Critical Care Medicine, Peking University First Hospital, No. 8 Xishiku Street, Xicheng District, Beijing, 100034, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Tian', 'Affiliation': 'Department of Urology, Peking University First Hospital, No. 8 Xishiku Street, Xicheng District, Beijing, 100034, China.'}, {'ForeName': 'Zhengqing', 'Initials': 'Z', 'LastName': 'Bao', 'Affiliation': 'Department of Urology, Peking University First Hospital, No. 8 Xishiku Street, Xicheng District, Beijing, 100034, China.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Endocrinology, Peking University First Hospital, No. 8 Xishiku Street, Xicheng District, Beijing, 100034, China.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Wu', 'Affiliation': 'Department of Endocrinology, Peking University First Hospital, No. 8 Xishiku Street, Xicheng District, Beijing, 100034, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Gao', 'Affiliation': 'Department of Endocrinology, Peking University First Hospital, No. 8 Xishiku Street, Xicheng District, Beijing, 100034, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Jin', 'Affiliation': 'Department of Clinical Laboratory, Peking University First Hospital, No. 8 Xishiku Street, Xicheng District, Beijing, 100034, China.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Urology, Peking University First Hospital, No. 8 Xishiku Street, Xicheng District, Beijing, 100034, China. doczhz@aliyun.com.'}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Fang', 'Affiliation': 'Department of Urology, Peking University First Hospital, No. 8 Xishiku Street, Xicheng District, Beijing, 100034, China. fdmailbox@126.com.'}, {'ForeName': 'Junqing', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Endocrinology, Peking University First Hospital, No. 8 Xishiku Street, Xicheng District, Beijing, 100034, China. 13611167278@139.com.'}, {'ForeName': 'Liqun', 'Initials': 'L', 'LastName': 'Zhou', 'Affiliation': 'Department of Urology, Peking University First Hospital, No. 8 Xishiku Street, Xicheng District, Beijing, 100034, China.'}]",International urology and nephrology,['10.1007/s11255-020-02539-2']
1267,32621898,The Aravind Pseudoexfoliation Study: 5-Year Postoperative Results. The Effect of Intraocular Lens Choice and Capsular Tension Rings.,"PURPOSE


We compared rates of intraocular lens (IOL) decentration, neodymium-doped yttrium aluminum garnet capsulotomy for posterior capsule opacification (PCO), and visual acuity (VA) in eyes with and without pseudoexfoliation (PEX) 5 years after undergoing cataract surgery.
DESIGN


Prospective comparative interventional study.
METHODS


This multicenter study population included 1 eye of both 930 cataract patients with and 470 cataract patients without uncomplicated PEX (no small pupils or phacodonesis) all undergoing phacoemulsification by experienced Aravind Eye Care System surgeons. Eyes were randomized to either 1- or 3-piece intraocular lenses (IOLs). PEX eyes were also randomized to either receive or not receive a capsule tension ring. The main outcome measures included IOL decentration and PCO. Secondary outcomes included postoperative best-corrected VA.
RESULTS


Follow-up was 86.2% in the PEX group and 86.7% in the control group at 5 years. The PEX group was older (P < .001) and had more men (P = .01). IOL decentration at 5 years was equally prevalent in PEX and control eyes (1.0% vs 1.1%, respectively, P = .8). Neodymium-doped yttrium aluminum garnet posterior capsulotomy rates for PCO were similar in the PEX group when compared with control subejcts (5.3% compared with 3.2%, respectively, P = .07). Best corrected VA was better at baseline and years 2 and 3 in the control group (P = .0001, P = .0005, and P = .02); however, there was no difference in BCVA at years 1, 4, and 5 between the PEX and control groups (P = .09, P = .29, and P = .5).
CONCLUSION


In a large-scale, long-term, prospective comparative study of cataract surgery in eyes with uncomplicated PEX, the risks of IOL decentration and PCO were low and comparable to that in control subjects. When approaching cataract surgery in eyes with relatively uncomplicated PEX, neither IOL choice (1- vs 3-piece acrylic IOL) nor the presence/absence of a capsule tension ring affects outcomes at 5 years.",2020,"Nd:YAG posterior capsulotomy rates for PCO were similar in the PEX group when compared to controls (5.3% compared to 3.2%, respectively, p=0.07).","['eyes with and without pseudoexfoliation (PEX) 5 years after undergoing cataract surgery', '930 cataract patients with, and 470 cataract patients without, uncomplicated PEX (no small pupils or phacodonesis) all undergoing phacoemulsification by experienced Aravind Eye Care System surgeons', 'PEX eyes']","['one-piece or three-piece intraocular lenses (IOL', 'PEX', 'IOL decentration, Nd:YAG capsulotomy', 'capsule tension ring (CTR', 'cataract surgery']","['PCO', 'post-operative best corrected VA', 'IOL decentration', 'IOL decentration and posterior capsular opacification (PCO', 'Best corrected visual acuity (BCVA', 'BCVA', 'posterior capsule opacification (PCO), and visual acuity (VA']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0086543', 'cui_str': 'Cataract'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0026205', 'cui_str': 'Persistent miosis'}, {'cui': 'C2939415', 'cui_str': 'Phacodonesis'}, {'cui': 'C0282545', 'cui_str': 'Phacoemulsification'}, {'cui': 'C0885957', 'cui_str': 'Eye care'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}]","[{'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}, {'cui': 'C2609312', 'cui_str': 'Intraocular lens decentration'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0233494', 'cui_str': 'Tension'}, {'cui': 'C0521164', 'cui_str': 'Annular shape'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}]","[{'cui': 'C1306068', 'cui_str': 'Secondary cataract'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C2609312', 'cui_str': 'Intraocular lens decentration'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C1444680', 'cui_str': 'Posterior capsule opacification'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}]",,0.0815359,"Nd:YAG posterior capsulotomy rates for PCO were similar in the PEX group when compared to controls (5.3% compared to 3.2%, respectively, p=0.07).","[{'ForeName': 'Aravind', 'Initials': 'A', 'LastName': 'Haripriya', 'Affiliation': 'Aravind Eye Hospital, Chennai, India.'}, {'ForeName': 'Pradeep Y', 'Initials': 'PY', 'LastName': 'Ramulu', 'Affiliation': 'Wilmer Eye Institute and Bloomberg School of Public Health, The Johns Hopkins University, Baltimore, Maryland, USA.'}, {'ForeName': 'Emily M', 'Initials': 'EM', 'LastName': 'Schehlein', 'Affiliation': 'Kellogg Eye Center, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Madhu', 'Initials': 'M', 'LastName': 'Shekhar', 'Affiliation': 'Aravind Eye Care System, Madurai, India.'}, {'ForeName': 'Shivkumar', 'Initials': 'S', 'LastName': 'Chandrashekharan', 'Affiliation': 'Aravind Eye Hospital, Thirunelveli, India.'}, {'ForeName': 'Kalpana', 'Initials': 'K', 'LastName': 'Narendran', 'Affiliation': 'Aravind Eye Hospital, Coimbatore, India.'}, {'ForeName': 'Rengaraj', 'Initials': 'R', 'LastName': 'Venkatesh', 'Affiliation': 'Aravind Eye Hospital, Pondicherry, India.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Sithiq', 'Affiliation': 'Aravind Eye Care System, Madurai, India.'}, {'ForeName': 'Rengappa', 'Initials': 'R', 'LastName': 'Ramakrishnan', 'Affiliation': 'Aravind Eye Hospital, Thirunelveli, India.'}, {'ForeName': 'Ravilla D', 'Initials': 'RD', 'LastName': 'Ravindran', 'Affiliation': 'Aravind Eye Care System, Madurai, India.'}, {'ForeName': 'Alan L', 'Initials': 'AL', 'LastName': 'Robin', 'Affiliation': 'Wilmer Eye Institute and Bloomberg School of Public Health, The Johns Hopkins University, Baltimore, Maryland, USA; Kellogg Eye Center, University of Michigan, Ann Arbor, Michigan, USA. Electronic address: arobin@glaucomaexpert.com.'}]",American journal of ophthalmology,['10.1016/j.ajo.2020.06.031']
1268,32641706,Cerebellar transcranial alternating current stimulation in the gamma range applied during the acquisition of a novel motor skill.,"The development of novel strategies to augment motor training success is of great interest for healthy persons and neurological patients. A promising approach is the combination of training with transcranial electric stimulation. However, limited reproducibility and varying effect sizes make further protocol optimization necessary. We tested the effects of a novel cerebellar transcranial alternating current stimulation protocol (tACS) on motor skill learning. Furthermore, we studied underlying mechanisms by means of transcranial magnetic stimulation and analysis of fMRI-based resting-state connectivity. N = 15 young, healthy participants were recruited. 50 Hz tACS was applied to the left cerebellum in a double-blind, sham-controlled, cross-over design concurrently to the acquisition of a novel motor skill. Potential underlying mechanisms were assessed by studying short intracortical inhibition at rest (SICI rest ) and in the premovement phase (SICI move ), intracortical facilitation at rest (ICF rest ), and seed-based resting-state fMRI-based functional connectivity (FC) in a hypothesis-driven motor learning network. Active stimulation did not enhance skill acquisition or retention. Minor effects on striato-parietal FC were present. Linear mixed effects modelling identified SICI move  modulation and baseline task performance as the most influential determining factors for predicting training success. Accounting for the identified factors may allow to stratify participants for future training-based interventions.",2020,Linear mixed effects modelling identified SICI move  modulation and baseline task performance as the most influential determining factors for predicting training success.,"['N\u2009=\u200915 young, healthy participants were recruited', 'healthy persons and neurological patients']","['novel cerebellar transcranial alternating current stimulation protocol (tACS', 'Cerebellar transcranial alternating current stimulation']","['skill acquisition or retention', 'striato-parietal FC', 'motor skill learning']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0007765', 'cui_str': 'Cerebellar structure'}, {'cui': 'C3852966', 'cui_str': 'Transcranial Alternating Current Stimulation'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0442030', 'cui_str': 'Parietal'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0026612', 'cui_str': 'Motor Skills'}, {'cui': 'C0023185', 'cui_str': 'Learning'}]",,0.090656,Linear mixed effects modelling identified SICI move  modulation and baseline task performance as the most influential determining factors for predicting training success.,"[{'ForeName': 'Maximilian J', 'Initials': 'MJ', 'LastName': 'Wessel', 'Affiliation': 'Defitech Chair of Clinical Neuroengineering, Center for Neuroprosthetics (CNP) and Brain Mind Institute (BMI), Swiss Federal Institute of Technology (EPFL), Campus Biotech, Chemin des Mines 9, 1202, Geneva, Switzerland. maximilian.wessel@epfl.ch.'}, {'ForeName': 'Laurijn R', 'Initials': 'LR', 'LastName': 'Draaisma', 'Affiliation': 'Defitech Chair of Clinical Neuroengineering, Center for Neuroprosthetics (CNP) and Brain Mind Institute (BMI), Swiss Federal Institute of Technology (EPFL), Campus Biotech, Chemin des Mines 9, 1202, Geneva, Switzerland.'}, {'ForeName': 'Anne F W', 'Initials': 'AFW', 'LastName': 'de Boer', 'Affiliation': 'Defitech Chair of Clinical Neuroengineering, Center for Neuroprosthetics (CNP) and Brain Mind Institute (BMI), Swiss Federal Institute of Technology (EPFL), Campus Biotech, Chemin des Mines 9, 1202, Geneva, Switzerland.'}, {'ForeName': 'Chang-Hyun', 'Initials': 'CH', 'LastName': 'Park', 'Affiliation': 'Defitech Chair of Clinical Neuroengineering, Center for Neuroprosthetics (CNP) and Brain Mind Institute (BMI), Swiss Federal Institute of Technology (EPFL), Campus Biotech, Chemin des Mines 9, 1202, Geneva, Switzerland.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Maceira-Elvira', 'Affiliation': 'Defitech Chair of Clinical Neuroengineering, Center for Neuroprosthetics (CNP) and Brain Mind Institute (BMI), Swiss Federal Institute of Technology (EPFL), Campus Biotech, Chemin des Mines 9, 1202, Geneva, Switzerland.'}, {'ForeName': 'Manon', 'Initials': 'M', 'LastName': 'Durand-Ruel', 'Affiliation': 'Defitech Chair of Clinical Neuroengineering, Center for Neuroprosthetics (CNP) and Brain Mind Institute (BMI), Swiss Federal Institute of Technology (EPFL), Campus Biotech, Chemin des Mines 9, 1202, Geneva, Switzerland.'}, {'ForeName': 'Philipp J', 'Initials': 'PJ', 'LastName': 'Koch', 'Affiliation': 'Defitech Chair of Clinical Neuroengineering, Center for Neuroprosthetics (CNP) and Brain Mind Institute (BMI), Swiss Federal Institute of Technology (EPFL), Campus Biotech, Chemin des Mines 9, 1202, Geneva, Switzerland.'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Morishita', 'Affiliation': 'Defitech Chair of Clinical Neuroengineering, Center for Neuroprosthetics (CNP) and Brain Mind Institute (BMI), Swiss Federal Institute of Technology (EPFL), Campus Biotech, Chemin des Mines 9, 1202, Geneva, Switzerland.'}, {'ForeName': 'Friedhelm C', 'Initials': 'FC', 'LastName': 'Hummel', 'Affiliation': 'Defitech Chair of Clinical Neuroengineering, Center for Neuroprosthetics (CNP) and Brain Mind Institute (BMI), Swiss Federal Institute of Technology (EPFL), Campus Biotech, Chemin des Mines 9, 1202, Geneva, Switzerland.'}]",Scientific reports,['10.1038/s41598-020-68028-9']
1269,32641723,Adaptive light: a lighting control method aligned with dark adaptation of human vision.,"Light exposure before sleep causes a reduction in the quality and duration of sleep. In order to reduce these detrimental effects of light exposure, it is important to dim the light. However, dimming the light often causes inconvenience and can lower the quality of life (QOL). We therefore aimed to develop a lighting control method for use before going to bed, in which the illuminance of lights can be ramped down with less of a subjective feeling of changes in illuminance. We performed seven experiments in a double-blind, randomized crossover design. In each experiment, we compared two lighting conditions. We examined constant illuminance, linear dimming, and three monophasic and three biphasic exponential dimming, to explore the fast and slow increases in visibility that reflect the dark adaptation of cone and rod photoreceptors in the retina, respectively. Finally, we developed a biphasic exponential dimming method termed Adaptive Light 1.0. Adaptive Light 1.0 significantly prevented the misidentification seen in constant light and effectively suppressed perceptions of the illuminance change. This novel lighting method will help to develop new intelligent lighting instruments that reduce the negative effect of light on sleep and also lower energy consumption.",2020,Adaptive Light 1.0 significantly prevented the misidentification seen in constant light and effectively suppressed perceptions of the illuminance change.,['human vision'],[],"['quality and duration of sleep', 'quality of life (QOL']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}]",[],"[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.0215216,Adaptive Light 1.0 significantly prevented the misidentification seen in constant light and effectively suppressed perceptions of the illuminance change.,"[{'ForeName': 'Yui', 'Initials': 'Y', 'LastName': 'Takemura', 'Affiliation': 'Department of Electrical Engineering and Bioscience, Graduate School of Sciences and Engineering, Waseda University, TWIns, Wakamatsucho 2-2, Shinjuku-Ku, Tokyo, 162-8480, Japan.'}, {'ForeName': 'Masaharu', 'Initials': 'M', 'LastName': 'Ito', 'Affiliation': 'Department of Electrical Engineering and Bioscience, Graduate School of Sciences and Engineering, Waseda University, TWIns, Wakamatsucho 2-2, Shinjuku-Ku, Tokyo, 162-8480, Japan.'}, {'ForeName': 'Yushi', 'Initials': 'Y', 'LastName': 'Shimizu', 'Affiliation': 'Department of Electrical Engineering and Bioscience, Graduate School of Sciences and Engineering, Waseda University, TWIns, Wakamatsucho 2-2, Shinjuku-Ku, Tokyo, 162-8480, Japan.'}, {'ForeName': 'Keiko', 'Initials': 'K', 'LastName': 'Okano', 'Affiliation': 'Department of Electrical Engineering and Bioscience, Graduate School of Sciences and Engineering, Waseda University, TWIns, Wakamatsucho 2-2, Shinjuku-Ku, Tokyo, 162-8480, Japan.'}, {'ForeName': 'Toshiyuki', 'Initials': 'T', 'LastName': 'Okano', 'Affiliation': 'Department of Electrical Engineering and Bioscience, Graduate School of Sciences and Engineering, Waseda University, TWIns, Wakamatsucho 2-2, Shinjuku-Ku, Tokyo, 162-8480, Japan. okano@waseda.jp.'}]",Scientific reports,['10.1038/s41598-020-68119-7']
1270,32641747,Efficacy of eribulin for metastatic breast cancer based on localization of specific secondary metastases: a post hoc analysis.,"Prior pooled analysis of eribulin studies (301 and 305) indicated eribulin prolonged overall survival (OS) in patients with locally advanced/metastatic breast cancer (MBC) regardless of visceral or nonvisceral disease. This hypothesis-generating post hoc analysis examined the efficacy of eribulin according to the location of metastatic sites at baseline in 1864 pretreated patients with locally advanced/MBC from studies 301 and 305. Analyses included OS, progression-free survival (PFS), and objective response rate; OS and PFS were also analyzed according to estrogen-receptor status. Eribulin appeared efficacious in patients with locally advanced/MBC, irrespective of the location of metastases at baseline. A nominally significant difference in OS in favor of patients randomized to eribulin compared with control in patients with bone, lymph node, and chest wall/breast/skin metastases at baseline was observed. Additionally, a difference in OS was also seen in patients with liver metastases randomized to eribulin versus control (median: 13.4 versus 11.3 months, respectively; hazard ratio, 0.84 [95% CI: 0.72, 0.97]). Results of this exploratory analysis suggest that eribulin may be efficacious for the treatment of locally advanced/MBC for patients with bone, liver, lung, lymph node, and chest wall/breast/skin metastases.",2020,"Eribulin appeared efficacious in patients with locally advanced/MBC, irrespective of the location of metastases at baseline.","['patients with locally advanced/MBC', 'patients with locally advanced/metastatic breast cancer (MBC) regardless of visceral or nonvisceral disease', '1864 pretreated patients with locally advanced/MBC from studies 301 and 305']",['eribulin'],"['OS', 'eribulin prolonged overall survival (OS', 'OS, progression-free survival (PFS), and objective response rate; OS and PFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0065839', 'cui_str': 'Carbendazim'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}, {'cui': 'C0442045', 'cui_str': 'Visceral'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517703', 'cui_str': '305'}]","[{'cui': 'C2350866', 'cui_str': 'eribulin'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C2350866', 'cui_str': 'eribulin'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]",1864.0,0.0619688,"Eribulin appeared efficacious in patients with locally advanced/MBC, irrespective of the location of metastases at baseline.","[{'ForeName': 'Joyce', 'Initials': 'J', 'LastName': ""O'Shaughnessy"", 'Affiliation': 'Baylor University Medical Center, Texas Oncology and US Oncology, Dallas, TX, USA. joyce.oshaughnessy@usoncology.com.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Cortes', 'Affiliation': ""IOB Institute of Oncology, Quironsalud Group, Madrid and Barcelona & Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain.""}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Twelves', 'Affiliation': ""Leeds Institute of Medical Research at St James's and Leeds Teaching Hospitals Trust, Leeds, UK.""}, {'ForeName': 'Lori J', 'Initials': 'LJ', 'LastName': 'Goldstein', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, PA, USA.'}, {'ForeName': 'Karenza', 'Initials': 'K', 'LastName': 'Alexis', 'Affiliation': 'Eisai Inc., Woodcliff Lake, NJ, USA.'}, {'ForeName': 'Ran', 'Initials': 'R', 'LastName': 'Xie', 'Affiliation': 'Eisai Inc., Woodcliff Lake, NJ, USA.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Barrios', 'Affiliation': 'Latin American Cooperative Oncology Group (LACOG), Porto Alegre, Brazil.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Ueno', 'Affiliation': 'Breast Oncology Center, The Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan.'}]",Scientific reports,['10.1038/s41598-020-66980-0']
1271,32651711,Safety of one-stage bilateral total knee arthroplasty -one surgeon sequential vs. two surgeons simultaneous: a randomized controlled study.,"PURPOSE


This study aimed to examine the complications by comparing two surgeons simultaneous bilateral total knee arthroplasty (two-surgeon bilateral TKA) to one surgeon sequential bilateral total knee arthroplasty (single-surgeon bilateral TKA).
METHODS


Two hundred forty-six participants were prospectively randomized into two groups: two-surgeon bilateral TKA and single-surgeon bilateral TKA. While two surgeons performed simultaneous total knee arthroplasty in the two-surgeon bilateral TKA group, one surgeon performed sequentially in the single-surgeon bilateral TKA group. Ninety-day major, and minor complications rate, operative time, estimated blood loss (EBL) and patient-reported outcome measures were analysed.
RESULTS


The two surgeons operated in two-surgeon bilateral TKA group 246 knees in 123 patients, while the single surgeon operated in single-surgeon bilateral TKA group 246 knees of 123 patients. The median operating time was 120 (range 70-151) minutes in the two-surgeon bilateral TKA group and 140 (range 75-190) minutes in the single-surgeon bilateral TKA group (p < 0.001). The median EBL was higher in the two-surgeon bilateral TKA group (p < 0.001). The 90-day complications were two major complications (1.6%) in the two-surgeon bilateral TKA group and 11 (8.9%) in the single-surgeon bilateral TKA group (p = 0.01).
CONCLUSION


Two-surgeon simultaneous bilateral TKA is a safe method with lower complication rates compared with single-surgeon sequential bilateral TKA and can be preferred for experienced teams. However, peri- and post-operative care is required to decrease the risk of bleeding, particularly in patients undergoing two-surgeon simultaneous bilateral TKA.
TRIAL REGISTRATION


This study was retrospectively registered in a public trials registry ( https://clinicaltrials.gov/ , NCT04299516).",2020,The median EBL was higher in the two-surgeon bilateral TKA group (p < 0.001).,"['group 246 knees of 123 patients', 'Two hundred forty-six participants']","['two-surgeon bilateral TKA and single-surgeon bilateral TKA', 'single surgeon operated in single-surgeon bilateral TKA', 'surgeons simultaneous bilateral total knee arthroplasty (two-surgeon bilateral TKA', 'one-stage bilateral total knee arthroplasty\xa0-one surgeon sequential vs. two surgeons simultaneous', 'surgeon sequential bilateral total knee arthroplasty (single-surgeon bilateral TKA']","['complication rates', '90-day complications', 'minor complications rate, operative time, estimated blood loss (EBL', 'median EBL', 'risk of bleeding', 'median operating time', 'simultaneous total knee arthroplasty']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C1443559', 'cui_str': 'Estimated blood loss'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]",246.0,0.188458,The median EBL was higher in the two-surgeon bilateral TKA group (p < 0.001).,"[{'ForeName': 'Gökçer', 'Initials': 'G', 'LastName': 'Uzer', 'Affiliation': 'Department of Orthopaedics and Traumatology, Bezmialem Vakıf University, İskender Paşa Mh Adnan Menderes Bulvarı, Adnan Menderes Blv., Fatih, 34093, İstanbul, Turkey.'}, {'ForeName': 'Orkhan', 'Initials': 'O', 'LastName': 'Aliyev', 'Affiliation': 'Department of Orthopaedics and Traumatology, Bezmialem Vakıf University, İskender Paşa Mh Adnan Menderes Bulvarı, Adnan Menderes Blv., Fatih, 34093, İstanbul, Turkey.'}, {'ForeName': 'Fatih', 'Initials': 'F', 'LastName': 'Yıldız', 'Affiliation': 'Department of Orthopaedics and Traumatology, Bezmialem Vakıf University, İskender Paşa Mh Adnan Menderes Bulvarı, Adnan Menderes Blv., Fatih, 34093, İstanbul, Turkey. yildizfatih@hotmail.com.'}, {'ForeName': 'Nurdan', 'Initials': 'N', 'LastName': 'Güngören', 'Affiliation': 'Department of Orthopaedics and Traumatology, Bezmialem Vakıf University, İskender Paşa Mh Adnan Menderes Bulvarı, Adnan Menderes Blv., Fatih, 34093, İstanbul, Turkey.'}, {'ForeName': 'Nurzat', 'Initials': 'N', 'LastName': 'Elmalı', 'Affiliation': 'Department of Orthopaedics and Traumatology, Bezmialem Vakıf University, İskender Paşa Mh Adnan Menderes Bulvarı, Adnan Menderes Blv., Fatih, 34093, İstanbul, Turkey.'}, {'ForeName': 'İbrahim', 'Initials': 'İ', 'LastName': 'Tuncay', 'Affiliation': 'Department of Orthopaedics and Traumatology, Bezmialem Vakıf University, İskender Paşa Mh Adnan Menderes Bulvarı, Adnan Menderes Blv., Fatih, 34093, İstanbul, Turkey.'}]",International orthopaedics,['10.1007/s00264-020-04704-9']
1272,32652863,Impact of interval walking training managed through smart mobile devices on albuminuria and leptin/adiponectin ratio in patients with type 2 diabetes.,"BACKGROUND


Interval walking training has demonstrated more pronounced positive effects on physical fitness and metabolism in type 2 diabetes (T2D), compared to continuous walking. One of the pathogenic mechanisms of T2D is associated with derangements in leptin/adiponectin axis, which might predispose affected individuals to vascular inflammation and albuminuria. The aim of this study was to investigate the effects of interval walking training delivered through smart mobile devices upon albuminuria and leptin/adiponectin ratio in patients with T2D.
METHODS


Patients with T2D aged 35-75 were randomized into control (n = 26) and interval training (IT, n = 14) groups. Patients in IT group had to perform three 60-min interval walking sessions (3 min intervals of slow and fast walking with the intensity of 40% and 70% of the peak energy expenditure) per week delivered by smartphone application for four months. The adherence to training was monitored remotely. Outcome measures were albuminuria, leptin/adiponectin ratio, obesity indicators, and glycaemic control. Leptin and adiponectin concentration was measured in serum samples by Luminex technology.
RESULTS


In the IT group compared to control group, we observed a statistically significant decrease in albuminuria (p = .002) and leptin/adiponectin ratio (p = .01), as well as a decrease in HbA1c close to statistical significance (p = .09). In IT group, changes in leptin/adiponectin ratio correlated significantly with changes in hip circumference (p = .024).
CONCLUSION


Interval walking training is beneficial for vascular health in T2D via impact on albuminuria and leptin/adiponectin ratio.",2020,"In IT group, changes in leptin/adiponectin ratio correlated significantly with changes in hip circumference (p = .024).
","['patients with T2D.\nMETHODS\n\n\nPatients with T2D aged 35-75', 'patients with type 2 diabetes']","['interval walking training managed through smart mobile devices', 'smart mobile devices', 'interval walking training', 'Interval walking training']","['hip circumference', 'albuminuria and leptin/adiponectin ratio', 'Leptin and adiponectin concentration', 'albuminuria, leptin/adiponectin ratio, obesity indicators, and glycaemic control', 'leptin/adiponectin ratio', 'changes in leptin/adiponectin ratio', 'albuminuria']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0235048', 'cui_str': 'Smarting pain'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0562350', 'cui_str': 'Hip circumference'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",75.0,0.0424762,"In IT group, changes in leptin/adiponectin ratio correlated significantly with changes in hip circumference (p = .024).
","[{'ForeName': 'Jelizaveta', 'Initials': 'J', 'LastName': 'Sokolovska', 'Affiliation': 'Faculty of Medicine, University of Latvia, Riga, Latvia.'}, {'ForeName': 'Karina', 'Initials': 'K', 'LastName': 'Ostrovska', 'Affiliation': 'Latvian Academy of Sport Education, Riga, Latvia.'}, {'ForeName': 'Leonora', 'Initials': 'L', 'LastName': 'Pahirko', 'Affiliation': 'Faculty of Physics, Mathematics and Optometry, University of Latvia, Riga, Latvia.'}, {'ForeName': 'Gunita', 'Initials': 'G', 'LastName': 'Varblane', 'Affiliation': 'Faculty of Medicine, University of Latvia, Riga, Latvia.'}, {'ForeName': 'Ksenija', 'Initials': 'K', 'LastName': 'Krilatiha', 'Affiliation': 'Faculty of Computing, University of Latvia, Riga, Latvia.'}, {'ForeName': 'Austris', 'Initials': 'A', 'LastName': 'Cirulnieks', 'Affiliation': 'Faculty of Computing, University of Latvia, Riga, Latvia.'}, {'ForeName': 'Inese', 'Initials': 'I', 'LastName': 'Folkmane', 'Affiliation': 'Faculty of Medicine, University of Latvia, Riga, Latvia.'}, {'ForeName': 'Valdis', 'Initials': 'V', 'LastName': 'Pirags', 'Affiliation': 'Faculty of Medicine, University of Latvia, Riga, Latvia.'}, {'ForeName': 'Janis', 'Initials': 'J', 'LastName': 'Valeinis', 'Affiliation': 'Faculty of Physics, Mathematics and Optometry, University of Latvia, Riga, Latvia.'}, {'ForeName': 'Aija', 'Initials': 'A', 'LastName': 'Klavina', 'Affiliation': 'Latvian Academy of Sport Education, Riga, Latvia.'}, {'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'Selavo', 'Affiliation': 'Faculty of Computing, University of Latvia, Riga, Latvia.'}]",Physiological reports,['10.14814/phy2.14506']
1273,32653895,Optimizing behavior therapy for youth with Tourette's disorder.,"Tourette's Disorder (TD) is characterized by tics that cause distress and impairment. While treatment guidelines recommend behavior therapy as a first-line intervention, patients with TD may exhibit limited therapeutic response. Given the need to improve treatment outcomes, this study examined the efficacy of augmenting behavior therapy with D-cycloserine (DCS) to reduce tic severity in a placebo-controlled quick-win/fast-fail trial. Twenty youth with TD completed a baseline assessment to characterize tic severity, premonitory urges, medical history, and psychiatric comorbidity. Youth were randomly assigned to receive a single session of habit reversal training (HRT) augmented by either 50 mg of DCS or placebo. Two bothersome tics on the Hopkins Motor/Vocal Tic Scale (HM/VTS) were targeted for treatment during HRT. One week after the HRT session, youth completed a posttreatment assessment to evaluate change in the severity of bothersome tics. All assessments were completed by independent evaluators masked to treatment group. There was a Treatment Group by Time Interaction in favor of DCS-augmented HRT (p < 0.01), controlling for baseline tic severity, tic medication, and attention deficit hyperactivity disorder. Follow-up comparisons revealed small group differences at the treatment visit (d = 0.27), with the DCS group exhibiting slightly greater severity for targeted tics. There was a large group difference at posttreatment, in which the DCS group exhibited lower severity for targeted tics (d = 1.30, p < 0.001) relative to the placebo group. Findings demonstrate the preliminary enhancement of tic severity reductions by augmenting HRT with DCS compared with placebo augmentation.",2020,"There was a Treatment Group by Time Interaction in favor of DCS-augmented HRT (p < 0.01), controlling for baseline tic severity, tic medication, and attention deficit hyperactivity disorder.","[""youth with Tourette's disorder"", 'Twenty youth with TD completed a baseline assessment to characterize tic severity, premonitory urges, medical history, and psychiatric comorbidity']","['placebo', 'habit reversal training (HRT) augmented by either 50\u2009mg of DCS or placebo', 'DCS', 'behavior therapy with D-cycloserine (DCS']","['Hopkins Motor/Vocal Tic Scale (HM/VTS', 'targeted tics', 'severity of bothersome tics']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0040517', 'cui_str': ""Gilles de la Tourette's syndrome""}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C3875152', 'cui_str': 'Characterizes'}, {'cui': 'C0040188', 'cui_str': 'Tic disorder'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0010590', 'cui_str': 'Cycloserine'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]","[{'cui': 'C0751901', 'cui_str': 'Tic, Vocal'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0040188', 'cui_str': 'Tic disorder'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",20.0,0.322576,"There was a Treatment Group by Time Interaction in favor of DCS-augmented HRT (p < 0.01), controlling for baseline tic severity, tic medication, and attention deficit hyperactivity disorder.","[{'ForeName': 'Joseph F', 'Initials': 'JF', 'LastName': 'McGuire', 'Affiliation': 'Division of Child and Adolescent Psychiatry, Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, USA. jfmcguire@jhmi.edu.'}, {'ForeName': 'Nathaniel', 'Initials': 'N', 'LastName': 'Ginder', 'Affiliation': 'Semel Institute for Neuroscience and Human Behavior, University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Kesley', 'Initials': 'K', 'LastName': 'Ramsey', 'Affiliation': 'Division of Child and Adolescent Psychiatry, Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Joey Ka-Yee', 'Initials': 'JK', 'LastName': 'Essoe', 'Affiliation': 'Division of Child and Adolescent Psychiatry, Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Emily J', 'Initials': 'EJ', 'LastName': 'Ricketts', 'Affiliation': 'Semel Institute for Neuroscience and Human Behavior, University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'James T', 'Initials': 'JT', 'LastName': 'McCracken', 'Affiliation': 'Semel Institute for Neuroscience and Human Behavior, University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Piacentini', 'Affiliation': 'Semel Institute for Neuroscience and Human Behavior, University of California Los Angeles, Los Angeles, CA, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0762-4']
1274,32636444,Assessment of the effects of sugammadex on coagulation profiles using thromboelastographic parameters.,"This study evaluated the effects of sugammadex at conventional doses of 2 and 4 mg/kg on the coagulation profile by analyzing thromboelastographic parameters and performing a traditional laboratory coagulation analysis. A total of 100 patients undergoing arthroscopic shoulder surgery were enrolled. The patients were randomly divided into the 2 mg and 4 mg groups. The laboratory coagulation test and thromboelastographic analysis were performed before and 15 min after administering sugammadex. Prothrombin time (PT) was significantly prolonged after sugammadex administration than before it in intragroup comparisons of the 2 mg group (12.8 ± 0.6 s vs. 13.6 ± 0.7 s, p < 0.001) and the 4 mg group (13.0 ± 0.5 s vs. 13.7 ± 0.5 s, p < 0.001). R time, derived from thromboelastography, was also significantly prolonged after sugammadex administration (4.7 ± 1.8 min vs. 5.8 ± 2.1 min, p = 0.005). In conclusion, the conventional doses of 2 or 4 mg/kg sugammadex prolonged PT. Sugammadex 4 mg/kg also prolonged R time, although the value was within the normal range. Therefore, physicians should be cautious with the higher sugammadex dose, particularly in patients with a high risk of bleeding because the higher dose was associated with less coagulation.Trial registration: KCT0002133 (https://cris.nih.go.kr).",2020,"Prothrombin time (PT) was significantly prolonged after sugammadex administration than before it in intragroup comparisons of the 2 mg group (12.8 ± 0.6 s vs. 13.6 ± 0.7 s, p < 0.001) and the 4 mg group (13.0 ± 0.5 s vs. 13.7 ± 0.5 s, p < 0.001).",['100 patients undergoing arthroscopic shoulder surgery were enrolled'],['sugammadex'],['Prothrombin time (PT'],"[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0186321', 'cui_str': 'Operative procedure on shoulder'}]","[{'cui': 'C1700695', 'cui_str': 'Sugammadex'}]","[{'cui': 'C0033707', 'cui_str': 'Prothrombin time'}]",100.0,0.0407057,"Prothrombin time (PT) was significantly prolonged after sugammadex administration than before it in intragroup comparisons of the 2 mg group (12.8 ± 0.6 s vs. 13.6 ± 0.7 s, p < 0.001) and the 4 mg group (13.0 ± 0.5 s vs. 13.7 ± 0.5 s, p < 0.001).","[{'ForeName': 'Woon-Seok', 'Initials': 'WS', 'LastName': 'Kang', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Konkuk University Medical Center, Konkuk University School of Medicine, 120-1, Neungdong-ro (Hwayang-dong), Gwangjin-gu, Seoul, 05030, Republic of Korea.'}, {'ForeName': 'Hoyoung', 'Initials': 'H', 'LastName': 'Lim', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Konkuk University Medical Center, Konkuk University School of Medicine, 120-1, Neungdong-ro (Hwayang-dong), Gwangjin-gu, Seoul, 05030, Republic of Korea.'}, {'ForeName': 'Byung-Soo', 'Initials': 'BS', 'LastName': 'Kim', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Konkuk University Medical Center, Konkuk University School of Medicine, 120-1, Neungdong-ro (Hwayang-dong), Gwangjin-gu, Seoul, 05030, Republic of Korea.'}, {'ForeName': 'Yeaji', 'Initials': 'Y', 'LastName': 'Lee', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Konkuk University Medical Center, Konkuk University School of Medicine, 120-1, Neungdong-ro (Hwayang-dong), Gwangjin-gu, Seoul, 05030, Republic of Korea.'}, {'ForeName': 'Kyung-Don', 'Initials': 'KD', 'LastName': 'Hahm', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Asan Medical Center, Ulasn University, Seoul, Republic of Korea.'}, {'ForeName': 'Seong-Hyop', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Konkuk University Medical Center, Konkuk University School of Medicine, 120-1, Neungdong-ro (Hwayang-dong), Gwangjin-gu, Seoul, 05030, Republic of Korea. yshkim75@daum.net.'}]",Scientific reports,['10.1038/s41598-020-68164-2']
1275,32640554,Psychological and Physiological Responses in Patients with Generalized Anxiety Disorder: The Use of Acute Exercise and Virtual Reality Environment.,"Virtual exercise therapy is considered a useful method by which to encourage patients with generalized anxiety disorder (GAD) to engage in aerobic exercise in order to reduce stress. This study was intended to explore the psychological and physiological responses of patients with GAD after cycling in a virtual environment containing natural images. Seventy-seven participants with GAD were recruited in the present study and randomly assigned to a virtual nature (VN) or a virtual abstract painting (VAP) group. Their electroencephalogram alpha activity, perceived stress, and levels of restorative quality and satisfaction were assessed at baseline and after an acute bout of 20 min of moderate-intensity aerobic exercise. The results showed that both the VN and VAP groups showed significantly higher alpha activity post-exercise as compared to pre-exercise. The VN group relative to the VAP group exhibited higher levels of stress-relief, restorative quality, and personal satisfaction. These findings imply that a virtual exercise environment is an effective way to induce a relaxing effect in patients with GAD. However, they exhibited more positive psychological responses when exercising in such an environment with natural landscapes.",2020,"The VN group relative to the VAP group exhibited higher levels of stress-relief, restorative quality, and personal satisfaction.","['Seventy-seven participants with GAD', 'Patients with Generalized Anxiety Disorder', 'patients with GAD', 'patients with GAD after cycling in a virtual environment containing natural images', 'patients with generalized anxiety disorder (GAD']","['VAP', 'virtual nature (VN) or a virtual abstract painting (VAP', 'Acute Exercise and Virtual Reality Environment', 'Virtual exercise therapy', 'virtual exercise environment']","['alpha activity post-exercise', 'Psychological and Physiological Responses', 'positive psychological responses', 'stress-relief, restorative quality, and personal satisfaction', 'electroencephalogram alpha activity, perceived stress, and levels of restorative quality and satisfaction']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}]","[{'cui': 'C0000857', 'cui_str': 'Abstracting as Topic'}, {'cui': 'C0030208', 'cui_str': 'Paintings'}, {'cui': 'C0349590', 'cui_str': 'Nature'}, {'cui': 'C4279937', 'cui_str': 'Acute Exercise'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0031206', 'cui_str': 'Personal wellbeing status'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",77.0,0.0381468,"The VN group relative to the VAP group exhibited higher levels of stress-relief, restorative quality, and personal satisfaction.","[{'ForeName': 'Tsai-Chiao', 'Initials': 'TC', 'LastName': 'Wang', 'Affiliation': 'Institute of Physical Education, Health & Leisure Studies, National Cheng Kung University, Tainan 701, Taiwan.'}, {'ForeName': 'Cindy Hui-Ping', 'Initials': 'CH', 'LastName': 'Sit', 'Affiliation': 'Department of Sports Science and Physical Education, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Ta-Wei', 'Initials': 'TW', 'LastName': 'Tang', 'Affiliation': 'Department of Leisure and Recreation Management, Asia University, Taichung 413, Taiwan.'}, {'ForeName': 'Chia-Liang', 'Initials': 'CL', 'LastName': 'Tsai', 'Affiliation': 'Institute of Physical Education, Health & Leisure Studies, National Cheng Kung University, Tainan 701, Taiwan.'}]",International journal of environmental research and public health,['10.3390/ijerph17134855']
1276,32640602,"Efficacy of a Six-Week Dispersed Wingate-Cycle Training Protocol on Peak Aerobic Power, Leg Strength, Insulin Sensitivity, Blood Lipids and Quality of Life in Healthy Adults.","BACKGROUND


The aim of this study was to evaluate the efficacy of a six-week dispersed Wingate Anaerobic test (WAnT) cycle exercise training protocol on peak aerobic power (VO 2peak ), isokinetic leg strength, insulin sensitivity, lipid profile and quality of life, in healthy adults.  Methods : We conducted a match-controlled cohort trial and participants were assigned to either the training (intervention, INT,  N  = 16) or non-training (control, CON,  N  = 17) group. INT performed 30-s WAnT bouts three times a day in the morning, afternoon and evening with each bout separated by ~4 h of rest, performed for 3 days a week for 6 weeks. Criterion measures of peak oxygen uptake (VO 2peak ), leg strength, insulin markers such as homeostatic model assessment (HOMA) and quantitative insulin-sensitivity check index (QUICKI), blood lipids profile and health-related quality of life (HRQL) survey were assessed before and after 6 weeks in both groups.  Results : Absolute VO 2peak  increased by 8.3 ± 7.0% ( p  < 0.001) after INT  vs . 0.9 ± 6.1% in CON ( p  = 0.41) group. Maximal voluntary contraction at 30°·s -1  of the dominant lower-limb flexors in INT increased significantly post-training ( p  = 0.03). There were no changes in the INT individuals' other cardiorespiratory markers, HOMA, QUICKI, blood lipids, and HRQL measures (all  p  > 0.05) between pre- and post-training; but importantly, no differences were observed between INT and CON groups (all  p  > 0.05).  Conclusion s : The results indicate that 6 weeks of dispersed sprint cycle training increased cardiorespiratory fitness and dynamic leg strength but had minimal impact on insulin sensitivity, blood lipids and quality of life in the exercising individuals.",2020,"There were no changes in the INT individuals' other cardiorespiratory markers, HOMA, QUICKI, blood lipids, and HRQL measures (all  p  > 0.05) between pre- and post-training; but importantly, no differences were observed between INT and CON groups (all  p  > 0.05).  ","['Healthy Adults', 'healthy adults']","['Six-Week Dispersed Wingate-Cycle Training Protocol', 'training (intervention, INT,  N  = 16) or non-training (control, CON,  N  = 17) group', 'dispersed sprint cycle training', 'CON', 'six-week dispersed Wingate Anaerobic test (WAnT) cycle exercise training protocol']","['Peak Aerobic Power, Leg Strength, Insulin Sensitivity, Blood Lipids and Quality of Life', 'peak oxygen uptake (VO 2peak ), leg strength, insulin markers such as homeostatic model assessment (HOMA) and quantitative insulin-sensitivity check index (QUICKI), blood lipids profile and health-related quality of life (HRQL) survey', 'cardiorespiratory fitness and dynamic leg strength', 'peak aerobic power (VO 2peak ), isokinetic leg strength, insulin sensitivity, lipid profile and quality of life', 'cardiorespiratory markers, HOMA, QUICKI, blood lipids, and HRQL measures', 'insulin sensitivity, blood lipids and quality of life', 'Absolute VO 2peak', 'Maximal voluntary contraction']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332624', 'cui_str': 'Dispersion'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C1283174', 'cui_str': 'Checking - action'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}]",,0.019415,"There were no changes in the INT individuals' other cardiorespiratory markers, HOMA, QUICKI, blood lipids, and HRQL measures (all  p  > 0.05) between pre- and post-training; but importantly, no differences were observed between INT and CON groups (all  p  > 0.05).  ","[{'ForeName': 'Chun Hou', 'Initials': 'CH', 'LastName': 'Wun', 'Affiliation': 'Department of Physiology, Yong Loo Lin School of Medicine, National University of Singapore, Singapore 117597, Singapore.'}, {'ForeName': 'Mandy Jiajia', 'Initials': 'MJ', 'LastName': 'Zhang', 'Affiliation': 'Changi Sports Medicine Centre, Changi General Hospital, Singapore 529889, Singapore.'}, {'ForeName': 'Boon Hor', 'Initials': 'BH', 'LastName': 'Ho', 'Affiliation': 'Changi Sports Medicine Centre, Changi General Hospital, Singapore 529889, Singapore.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'McGeough', 'Affiliation': 'ActiveSG, Active Health Division, Sport Singapore, Singapore 397630, Singapore.'}, {'ForeName': 'Frankie', 'Initials': 'F', 'LastName': 'Tan', 'Affiliation': 'Department of Physiology, Yong Loo Lin School of Medicine, National University of Singapore, Singapore 117597, Singapore.'}, {'ForeName': 'Abdul Rashid', 'Initials': 'AR', 'LastName': 'Aziz', 'Affiliation': 'Sport Science and Sport Medicine, Singapore Sport Institute, Sport Singapore, Singapore 397630, Singapore.'}]",International journal of environmental research and public health,['10.3390/ijerph17134860']
1277,32647277,Effectiveness of antimuscarinics and a beta-3 adrenoceptor agonist in patients with overactive bladder in a real-world setting.,"Both antimuscarinics and beta-3 adrenoceptor agonists are generally used as first-line pharmacotherapy for overactive bladder (OAB). This study aimed to investigate the differences in clinical characteristics and manifestations between different medication groups using real-world data. In this retrospective study, we recruited all patients aged > 18 years diagnosed with OAB at our institute from March 2010 to December 2017. They were allocated into three groups, the antimuscarinics (group A), beta-3 adrenoceptor agonist (group B), and discontinued (group C) treatment groups, and they completed OAB symptom score and quality of life questionnaires before and after treatment. In addition, the Clinical Global Impression was recorded for treatment outcomes. A premedication urodynamic study was also applied. A total of 215 patients were analyzed (group A: 43, B: 35, C: 137). Group B was significantly older (mean age 77.4 years) than group A (69.2 years, p = 0.012) and group C (68.6 years, p = 0.001). However, there were no significant differences in sex or underlying diseases among the groups. Before treatment, there were no significant differences in the questionnaire results among all groups. The cystometric capacity of group A (mean ± SD, 257.3 ± 135.1 cm 3 ) was significantly larger than that of group B (125.8 ± 46.0 cm 3 , p = 0.002) and group C (170.5 ± 99.2 cm 3 , p = 0.001). After treatment, there were no significant differences between group A and group B in any of the questionnaire scores; however, their scores were better than those of group C. The OAB patients who adhered to antimuscarinics tended to be younger and have larger cystometric bladder capacity in the urodynamic study. However, there were no significant differences in effectiveness between the patients who took antimuscarinics and those who took a beta-3 adrenoceptor agonist.",2020,"After treatment, there were no significant differences between group A and group B in any of the questionnaire scores; however, their scores were better than those of group C. The OAB patients who adhered to antimuscarinics tended to be younger and have larger cystometric bladder capacity in the urodynamic study.","['patients with overactive bladder in a real-world setting', 'patients aged >\u200918\xa0years diagnosed with OAB at our institute from March 2010 to December 2017', '215 patients were analyzed (group A: 43, B: 35, C: 137']","['antimuscarinics and a beta-3 adrenoceptor agonist', 'beta-3 adrenoceptor agonist']","['cystometric capacity', 'Clinical Global Impression', 'cystometric bladder capacity', 'OAB symptom score and quality of life questionnaires']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C4709308', 'cui_str': '215'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0003385', 'cui_str': 'Muscarinic receptor antagonist'}, {'cui': 'C4517569', 'cui_str': '137'}]","[{'cui': 'C0003385', 'cui_str': 'Muscarinic receptor antagonist'}, {'cui': 'C3252518', 'cui_str': 'ADRB3 protein, human'}, {'cui': 'C0243192', 'cui_str': 'agonists'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0429807', 'cui_str': 'Bladder capacity'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",215.0,0.0182709,"After treatment, there were no significant differences between group A and group B in any of the questionnaire scores; however, their scores were better than those of group C. The OAB patients who adhered to antimuscarinics tended to be younger and have larger cystometric bladder capacity in the urodynamic study.","[{'ForeName': 'Chiung-Kun', 'Initials': 'CK', 'LastName': 'Huang', 'Affiliation': 'Department of Urology, Taipei Veterans General Hospital, No. 201, Section 2, Shih-Pai Road, Taipei, 11217, Taiwan, ROC.'}, {'ForeName': 'Chih-Chieh', 'Initials': 'CC', 'LastName': 'Lin', 'Affiliation': 'Department of Urology, Taipei Veterans General Hospital, No. 201, Section 2, Shih-Pai Road, Taipei, 11217, Taiwan, ROC. jayslylin@gmail.com.'}, {'ForeName': 'Alex Tong-Long', 'Initials': 'AT', 'LastName': 'Lin', 'Affiliation': 'Department of Urology, Taipei Veterans General Hospital, No. 201, Section 2, Shih-Pai Road, Taipei, 11217, Taiwan, ROC.'}]",Scientific reports,['10.1038/s41598-020-68170-4']
1278,32645162,Patterns of Antiretroviral Therapy Use and Immunologic Profiles at Enrollment in the REPRIEVE Trial.,"BACKGROUND


Patterns of antiretroviral therapy (ART) use and immunologic correlates vary globally, and contemporary trends are not well described.
METHODS


The REPRIEVE trial (Randomized Trial to Prevent Vascular Events in HIV) enrolled persons with human immunodeficiency virus (HIV) who were aged 40-75 years, receiving ART, and had low-to-moderate cardiovascular disease risk. ART use was summarized within Global Burden of Disease (GBD) super-regions, with adjusted linear and logistic regression analyses examining associations with immune parameters and key demographics.
RESULTS


A total of 7770 participants were enrolled, with a median age of 50 years (interquartile range, 45-55 years); 31% were female, 43% were black or African American, 15% were Asian, 56% had a body mass index >25 (calculated as weight in kilograms divided by height in meters squared), and 49% were current or former smokers. The median CD4 T-cell count was 620/µL (interquartile range, 447-826/ µ L), and the median duration of prior ART use, 9.5 years (5.3-14.8) years. The most common ART regimens were nucleoside/nucleotide reverse-transcriptase inhibitor (NRTI) plus nonnucleoside reverse-transcriptase inhibitor (43%), NRTI plus integrase strand transfer inhibitor (25%), and NRTI plus protease inhibitor (19%). Entry ART varied by GBD region, with shifts during the trial enrollment period. In adjusted analyses, entry CD4 cell count and CD4/CD8 ratio were associated with GBD region, sex, entry regimen, duration of ART, and nadir CD4 cell count; CD4 and CD8 cell counts were also associated with body mass index and smoking status.
CONCLUSIONS


There were substantial variations in ART use by geographic region and over time, likely reflecting the local availability of specific medications, changes in treatment guidelines and provider/patient preferences. The analyses of CD4 cell counts and CD4/CD8 ratios may provide valuable insights regarding immune correlates and outcomes in people living with HIV.
CLINICAL TRIALS REGISTRATION


NCT02344290.",2020,"In adjusted analyses, entry CD4 cell count and CD4/CD8 ratio were associated with GBD region, sex, entry regimen, duration of ART, and nadir CD4 cell count; CD4 and CD8 cell counts were also associated with body mass index and smoking status.
","['HIV) enrolled persons with human immunodeficiency virus (HIV) who were aged 40-75 years, receiving ART, and had low-to-moderate cardiovascular disease risk', 'people living with HIV', '7770 participants were enrolled, with a median age of 50 years (interquartile range, 45-55 years); 31% were female, 43% were black or African American, 15% were Asian, 56% had a body mass index >25 (calculated as weight in kilograms divided by height in meters squared), and 49% were current or former smokers']",['nucleoside/nucleotide reverse-transcriptase inhibitor (NRTI)\u2005plus nonnucleoside reverse-transcriptase inhibitor'],"['GBD region, sex, entry regimen, duration of ART, and nadir CD4 cell count; CD4 and CD8 cell counts', 'entry CD4 cell count and CD4/CD8 ratio', 'median CD4 T-cell count']","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0439209', 'cui_str': 'kg'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0337671', 'cui_str': 'Ex-smoker'}]","[{'cui': 'C0028621', 'cui_str': 'Nucleoside'}, {'cui': 'C0028630', 'cui_str': 'Nucleotide'}, {'cui': 'C0282519', 'cui_str': 'Reverse transcriptase inhibitor'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C4277729', 'cui_str': 'Global Burden of Disease'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0242629', 'cui_str': 'Lymphocyte positive for CD8 antigen'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}]",7770.0,0.18883,"In adjusted analyses, entry CD4 cell count and CD4/CD8 ratio were associated with GBD region, sex, entry regimen, duration of ART, and nadir CD4 cell count; CD4 and CD8 cell counts were also associated with body mass index and smoking status.
","[{'ForeName': 'Carl J', 'Initials': 'CJ', 'LastName': 'Fichtenbaum', 'Affiliation': 'Division of Infectious Diseases, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA.'}, {'ForeName': 'Heather J', 'Initials': 'HJ', 'LastName': 'Ribaudo', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Leon-Cruz', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Edgar T', 'Initials': 'ET', 'LastName': 'Overton', 'Affiliation': 'Division of Infectious Diseases, University of Alabama at Birmingham School of Medicine, Birmingham, Alabama, USA.'}, {'ForeName': 'Markella V', 'Initials': 'MV', 'LastName': 'Zanni', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Carlos D', 'Initials': 'CD', 'LastName': 'Malvestutto', 'Affiliation': 'Division of Infectious Diseases, Ohio State University Medical Center, Columbus, Ohio, USA.'}, {'ForeName': 'Judith A', 'Initials': 'JA', 'LastName': 'Aberg', 'Affiliation': 'Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, New York, USA.'}, {'ForeName': 'Emma M', 'Initials': 'EM', 'LastName': 'Kileel', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Kathleen V', 'Initials': 'KV', 'LastName': 'Fitch', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Marije', 'Initials': 'M', 'LastName': 'Van Schalkwyk', 'Affiliation': 'Family Centre for Research with Ubuntu, Division of Adult Infectious Diseases, Stellenbosch University and Tygerberg Hospital, Cape Town, South Africa.'}, {'ForeName': 'Nagalingeswaran', 'Initials': 'N', 'LastName': 'Kumarasamy', 'Affiliation': 'Infectious Diseases Medical Centre, Voluntary Health Services, Chennai, India.'}, {'ForeName': 'Esteban', 'Initials': 'E', 'LastName': 'Martinez', 'Affiliation': 'Hospital Clinic and University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Breno Riegel', 'Initials': 'BR', 'LastName': 'Santos', 'Affiliation': 'Infectious Diseases Service, Hospital Nossa, Senhora da Conceição/GHC, Porto Alegre, Brazil.'}, {'ForeName': 'Yvetot', 'Initials': 'Y', 'LastName': 'Joseph', 'Affiliation': 'Les Centres GHESKIO, Port-au-Prince, Haiti.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Lo', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Siminski', 'Affiliation': 'Frontier Science and Technology Foundation, Amherst, Massachusetts, USA.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Melbourne', 'Affiliation': 'HIV Medical Sciences, Gilead Sciences, Foster City, California, USA.'}, {'ForeName': 'Craig A', 'Initials': 'CA', 'LastName': 'Sponseller', 'Affiliation': 'Kowa Pharmaceuticals America, Montgomery, Alabama, USA.'}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Desvigne-Nickens', 'Affiliation': 'National Heart, Lung and Blood Institute, Baltimore, Maryland, USA.'}, {'ForeName': 'Gerald S', 'Initials': 'GS', 'LastName': 'Bloomfield', 'Affiliation': 'Department of Medicine, Duke Global Health Institute and Duke Clinical Research Institute, Duke University, Durham, North Carolina, USA.'}, {'ForeName': 'Judith S', 'Initials': 'JS', 'LastName': 'Currier', 'Affiliation': 'Division of Infectious Diseases, University of California-Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Udo', 'Initials': 'U', 'LastName': 'Hoffmann', 'Affiliation': 'Cardiac MR PET CT Program and Department of Radiology, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Pamela S', 'Initials': 'PS', 'LastName': 'Douglas', 'Affiliation': 'Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Grinspoon', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of infectious diseases,['10.1093/infdis/jiaa259']
1279,32650074,A break-even analysis of benzoyl peroxide and hydrogen peroxide for infection prevention in shoulder arthroplasty.,"BACKGROUND


Newer strategies to decolonize the shoulder of Cutibacterium acnes may hold promise in minimizing the occurrence of infections after shoulder arthroplasty, but little is known about their cost-effectiveness. Break-even models can determine the economic viability of interventions in settings with low outcome event rates that would realistically preclude a randomized clinical trial. We used such modeling to determine the economic viability of benzoyl peroxide and hydrogen peroxide for infection prevention in shoulder arthroplasty.
METHODS


Skin decolonization protocol costs ($11.76 for benzoyl peroxide; $0.96 for hydrogen peroxide), baseline infection rates for shoulder arthroplasty (0.70%), and infection-related care costs ($50,230) were derived from institutional records and the literature. A break-even equation incorporating these variables was developed to determine the absolute risk reduction (ARR) in the infection rate to make prophylactic use economically justified. The number needed to treat was calculated from the ARR.
RESULTS


Topical benzoyl peroxide is considered economically justified if it prevents at least 1 infection out of 4348 shoulder arthroplasties (ARR = 0.023%). Hydrogen peroxide is economically justified if it prevents at least 1 infection out of 50,000 cases (ARR = 0.002%). These protocols remained economically viable at varying unit costs, initial infection rates, and infection-related care costs.
CONCLUSIONS


The use of topical benzoyl peroxide and skin preparations with hydrogen peroxide are highly economically justified practices for infection prevention in shoulder arthroplasty. Efforts to determine drawbacks of routine skin decolonization strategies are warranted as they may change the value analysis.",2020,"These protocols remained economically viable at varying unit costs, initial infection rates, and infection-related care costs.
","['shoulder arthroplasty', 'shoulder arthroplasty (0.70%), and infection-related care costs ($50,230', 'Shoulder Arthroplasty']","['benzoyl peroxide and hydrogen peroxide', 'Hydrogen peroxide', 'topical benzoyl peroxide and skin preparations with hydrogen peroxide', 'benzoyl peroxide; $0.96 for hydrogen peroxide', 'Benzoyl Peroxide and Hydrogen Peroxide']","['initial infection rates, and infection-related care costs']","[{'cui': 'C0186662', 'cui_str': 'Arthroplasty of shoulder'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]","[{'cui': 'C0005088', 'cui_str': 'Benzoyl Peroxide'}, {'cui': 'C0020281', 'cui_str': 'Hydrogen Peroxide'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0455085', 'cui_str': 'Skin preparation'}]","[{'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",50230.0,0.0321727,"These protocols remained economically viable at varying unit costs, initial infection rates, and infection-related care costs.
","[{'ForeName': 'Mariano E', 'Initials': 'ME', 'LastName': 'Menendez', 'Affiliation': 'Department of Orthopaedic Surgery, Tufts Medical Center, Tufts University School of Medicine, Boston, MA, USA; Department of Orthopaedic Surgery, Newton-Wellesley Hospital, Newton, MA, USA. Electronic address: marianofurrer@gmail.com.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Moverman', 'Affiliation': 'Department of Orthopaedic Surgery, Tufts Medical Center, Tufts University School of Medicine, Boston, MA, USA; Department of Orthopaedic Surgery, Newton-Wellesley Hospital, Newton, MA, USA.'}, {'ForeName': 'Richard N', 'Initials': 'RN', 'LastName': 'Puzzitiello', 'Affiliation': 'Department of Orthopaedic Surgery, Tufts Medical Center, Tufts University School of Medicine, Boston, MA, USA; Department of Orthopaedic Surgery, Newton-Wellesley Hospital, Newton, MA, USA.'}, {'ForeName': 'Nicholas R', 'Initials': 'NR', 'LastName': 'Pagani', 'Affiliation': 'Department of Orthopaedic Surgery, Tufts Medical Center, Tufts University School of Medicine, Boston, MA, USA; Department of Orthopaedic Surgery, Newton-Wellesley Hospital, Newton, MA, USA.'}, {'ForeName': 'Surena', 'Initials': 'S', 'LastName': 'Namdari', 'Affiliation': 'Rothman Institute, Thomas Jefferson University, Philadelphia, PA, USA.'}]",Journal of shoulder and elbow surgery,['10.1016/j.jse.2020.06.019']
1280,32650077,Deltopectoral vs. deltoid split approach for proximal HUmerus fracture fixation with locking plate: a prospective RAndomized study (HURA).,"BACKGROUND


This study aimed to compare the functional and clinical outcomes between the deltoid split (DS) approach and the classic deltopectoral (DP) approach for locking plate fixation of proximal humerus fractures (PHF) in a prospective randomized multicenter study.
METHODS


From 2007 to 2015, all patients with a PHF Neer II/III were invited to participate. Exclusion criteria were pre-existing pathology to the limb, patient refusing or too ill to undergo surgery, patient needing another type of treatment (nail, arthroplasty), and axillary nerve impairment. After consent, patients were randomized to one of the 2 treatments using the dark envelope method. Functional outcome was evaluated by validated questionnaires (12-Item Short Form Health Survey: version 2, Quick-DASH) with a minimum follow-up of 12 months. Complications were noted.
RESULTS


A total of 85 patients (44 DS, 41 DP) were randomized (mean age of 62). Groups were equivalent in terms of age, gender, body mass index, severity of fracture, and preinjury scores. The mean follow-up was 26 months. All clinical outcome measures were in favor of the deltopectoral approach. Specifically, the Q-DASH and SF-12v2 were better in the DP group (12 vs. 26, P = .003 and 56 vs. 51, P = .049, respectively). There were more complications in DS patients, but they did not reach statistical significance.
CONCLUSIONS


The primary hypothesis on the superiority of the deltoid split incision was rebutted. On the basis of our study, the DP approach seems to offer better function compared with the DS approach for fixation of Neer 2 and 3 PHF fractures fixed with a locking plate.",2020,"Specifically, the Q-DASH, was better in the DP group (12 vs 26, p=0,003) and SF-12v2: 56 vs 51, p=0,049, respectively).","['85 patients (44 DS, 41 DP', 'From 2007 to 2015, all patients with a PHF Neer II/III, were invited to participate', 'proximal humerus fractures (PHF', 'Exclusion criteria were: pre-existing pathology to the limb, patient refusing or too ill to undergo surgery, patient needing another type of treatment (nail, arthroplasty), and axillary nerve impairment']","['Delto-Pectoral vs Deltoid split approach', 'deltoid split (DS) approach and the classic deltopectoral (DP) approach']",['Complications'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0224234', 'cui_str': 'Structure of deltoid muscle'}, {'cui': 'C0450110', 'cui_str': 'Deltopectoral approach'}, {'cui': 'C0588209', 'cui_str': 'Bone structure of proximal humerus'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0027342', 'cui_str': 'Nail plate structure'}, {'cui': 'C0003893', 'cui_str': 'Arthroplasty'}, {'cui': 'C0228885', 'cui_str': 'Structure of axillary nerve'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}]","[{'cui': 'C0224234', 'cui_str': 'Structure of deltoid muscle'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0439658', 'cui_str': 'Classic'}, {'cui': 'C0450110', 'cui_str': 'Deltopectoral approach'}]","[{'cui': 'C0009566', 'cui_str': 'Complication'}]",,0.0329204,"Specifically, the Q-DASH, was better in the DP group (12 vs 26, p=0,003) and SF-12v2: 56 vs 51, p=0,049, respectively).","[{'ForeName': 'Dominique M', 'Initials': 'DM', 'LastName': 'Rouleau', 'Affiliation': 'CIUSS, Hopital Sacré Coeur de Montréal, Montréal, QC, Canada; Faculty of Medicine, Université de Montréal, Montréal, QC, Canada. Electronic address: dominique.rouleau@umontreal.ca.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Balg', 'Affiliation': 'Department of surgery, Centre universitaire de santé de Sherbrooke, Sherbrooke, QC, Canada.'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Benoit', 'Affiliation': 'CIUSS, Hopital Sacré Coeur de Montréal, Montréal, QC, Canada; Faculty of Medicine, Université de Montréal, Montréal, QC, Canada.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Leduc', 'Affiliation': 'CIUSS, Hopital Sacré Coeur de Montréal, Montréal, QC, Canada; Faculty of Medicine, Université de Montréal, Montréal, QC, Canada.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Malo', 'Affiliation': 'CIUSS, Hopital Sacré Coeur de Montréal, Montréal, QC, Canada; Faculty of Medicine, Université de Montréal, Montréal, QC, Canada.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Vézina', 'Affiliation': 'Department of surgery, Centre universitaire de santé de Sherbrooke, Sherbrooke, QC, Canada.'}, {'ForeName': 'G Yves', 'Initials': 'GY', 'LastName': 'Laflamme', 'Affiliation': 'CIUSS, Hopital Sacré Coeur de Montréal, Montréal, QC, Canada; Faculty of Medicine, Université de Montréal, Montréal, QC, Canada.'}]",Journal of shoulder and elbow surgery,['10.1016/j.jse.2020.06.020']
1281,32655245,A Comparative Study to Assess the Efficacy of Fractional Carbon Dioxide Laser and Combination of Fractional Carbon Dioxide Laser with Topical Autologous Platelet-rich Plasma in Post-acne Atrophic Scars.,"Context


Acne vulgaris is a chronic inflammatory disorder of the pilosebaceous unit prevalent in adolescent population. Atrophic acne scarring negatively affects the quality of life. Although challenging to treat, the introduction of fractional carbon dioxide (CO 2 ) laser and platelet-rich plasma (PRP) therapy for atrophic scars has opened up new avenues.
Aim


The aim of this study was to evaluate and compare the efficacy of fractional CO 2  laser alone and in combination with topical PRP in treating post-acne atrophic scars.
Subjects and Methods


A hospital-based prospective, double-blinded, randomized, and comparative study was conducted. A total of 33 cases with post-acne atrophic scars of moderate to severe grade were randomly allotted into Group A and Group B who were treated for three monthly sessions of fractional CO 2  laser followed by topical PRP and fractional CO 2  laser monotherapy, respectively. Evaluation at baseline and every visit was carried out and compared at the end of 12 weeks.
Results


Of the 33 patients, 25 completed the study. The mean change in score was higher in subjects of Group A. The mean scar score significantly reduced in both groups. The mean visual analog scale was higher in Group A. The reduction in scar score was significantly higher in patients with rolling scars and boxcar scars and least in ice pick scars. Erythema, edema, pain, and hyperpigmentation were higher in Group B.
Conclusion


Combination therapy with PRP is more efficacious in reducing post-acne atrophic scars and reducing adverse effects of laser therapy as compared to fractional CO 2  laser monotherapy.",2020,The reduction in scar score was significantly higher in patients with rolling scars and boxcar scars and least in ice pick scars.,"['33 patients', '33 cases with post-acne atrophic scars of moderate to severe grade', 'Subjects and Methods\n\n\nA hospital-based prospective', 'Post-acne Atrophic Scars']","['PRP', 'fractional carbon dioxide (CO 2 ) laser and platelet-rich plasma (PRP) therapy', 'fractional CO 2  laser followed by topical PRP and fractional CO 2  laser monotherapy', 'Fractional Carbon Dioxide Laser and Combination of Fractional Carbon Dioxide Laser with Topical Autologous Platelet-rich Plasma', 'fractional CO 2  laser alone and in combination with topical PRP']","['quality of life', 'mean visual analog scale', 'mean scar score', 'scar score', 'Erythema, edema, pain, and hyperpigmentation', 'mean change in score', 'adverse effects', 'Atrophic acne scarring']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0001144', 'cui_str': 'Acne vulgaris'}, {'cui': 'C0162154', 'cui_str': 'Atrophic scar'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}]","[{'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0392251', 'cui_str': 'Carbon dioxide laser device'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0162834', 'cui_str': 'Hyperpigmentation'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0333641', 'cui_str': 'Atrophy'}, {'cui': 'C0001144', 'cui_str': 'Acne vulgaris'}]",33.0,0.0307602,The reduction in scar score was significantly higher in patients with rolling scars and boxcar scars and least in ice pick scars.,"[{'ForeName': 'Nazneen Z', 'Initials': 'NZ', 'LastName': 'Arsiwala', 'Affiliation': 'Department of Dermatology, Shri B. M. Patil Medical College, Hospital and Research Centre, BLDE (Deemed to be University), Bijapur, Karnataka, India.'}, {'ForeName': 'Arun C', 'Initials': 'AC', 'LastName': 'Inamadar', 'Affiliation': 'Department of Dermatology, Shri B. M. Patil Medical College, Hospital and Research Centre, BLDE (Deemed to be University), Bijapur, Karnataka, India.'}, {'ForeName': 'Keshavmurthy A', 'Initials': 'KA', 'LastName': 'Adya', 'Affiliation': 'Department of Dermatology, Shri B. M. Patil Medical College, Hospital and Research Centre, BLDE (Deemed to be University), Bijapur, Karnataka, India.'}]",Journal of cutaneous and aesthetic surgery,['10.4103/JCAS.JCAS_142_19']
1282,32655246,Efficacy of Topical Timolol versus Saline in Chronic Venous Ulcers: A Randomized Controlled Trial.,"Background


Chronic venous ulcers sometimes fail to heal in spite of adequate treatment. Nonhealing is possibly because of chronic activation of β-2 adrenergic receptor (B2-AR) in the keratinocytes by endogenously generated catecholamines, which inhibits keratinocyte migration. Blocking of B2-AR using β-blockers has been reported to promote wound healing through keratinocyte migration, angiogenesis, and fibroblast migration. Topical timolol, a B2-AR antagonist, is used to promote wound healing.
Aims and Objectives


The aim of this study was to compare the efficacy of topical timolol versus saline in chronic venous leg ulcers and to compare the mean reduction in ulcer area at the end of 4 weeks.
Materials and Methods


Twenty patients were randomized into two groups. Patients in Group 1 were treated with one drop of 0.5% topical timolol every alternate days for 4 weeks. Ulcer margins were measured and ulcer area calculated every week for 4 weeks. Similar dressing and measurement were carried out for patients with saline for 4 weeks. Healing rate was assessed by the percentage of reduction of ulcer area of both groups at week 4.
Results


The mean reduction in the ulcer size in timolol group was 86.80%, and in saline group 43.82% at the end of 4 weeks.
Conclusion


Topical timolol is an easy, noninvasive therapy that can be recommended for chronic ulcer.",2020,"The mean reduction in the ulcer size in timolol group was 86.80%, and in saline group 43.82% at the end of 4 weeks.
","['Chronic Venous Ulcers', 'chronic venous leg ulcers']","['topical timolol', 'Topical timolol', 'Topical Timolol versus Saline', 'timolol', 'saline']","['Ulcer margins', 'Healing rate', 'ulcer size']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0042344', 'cui_str': 'Stasis ulcer'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0040233', 'cui_str': 'Timolol'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0456389', 'cui_str': 'Size'}]",20.0,0.0295115,"The mean reduction in the ulcer size in timolol group was 86.80%, and in saline group 43.82% at the end of 4 weeks.
","[{'ForeName': 'Abhay K', 'Initials': 'AK', 'LastName': 'Rai', 'Affiliation': 'Department of Dermatology, PSG Institute of Medical Sciences and Research (PSGIMSR), Coimbatore, Tamil Nadu, India.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Janani', 'Affiliation': 'Department of Dermatology, PSG Institute of Medical Sciences and Research (PSGIMSR), Coimbatore, Tamil Nadu, India.'}, {'ForeName': 'Reena', 'Initials': 'R', 'LastName': 'Rai', 'Affiliation': 'Department of Dermatology, PSG Institute of Medical Sciences and Research (PSGIMSR), Coimbatore, Tamil Nadu, India.'}]",Journal of cutaneous and aesthetic surgery,['10.4103/JCAS.JCAS_13_19']
1283,32662092,Effect of dipeptidyl peptidase-4 inhibitors on complement activation.,"BACKGROUND


Adverse activation of the complement cascade in the innate immune system appears to be involved in development of vascular complications in diabetes. Dipeptidyl peptidase-4 (DPP-4) is a cell surface serine protease expressed in a variety of tissues. DPP-4 inhibitors are widely used in treatment of type 2 diabetes and appear to yield beneficial pleiotropic effects beyond their glucose-lowering action, for example, renoprotective and anti-inflammatory properties, but the exact mechanisms remain unknown. We hypothesised that DPP-4 inhibitors block adverse complement activation by inhibiting complement-activating serine proteases.
MATERIALS AND METHODS


We analysed the effects of 7 different DPP-4 inhibitors on the lectin and classical pathway of the complement system in vitro by quantifying complement factor C4b deposition onto mannan or IgG coated surfaces, respectively. Furthermore, plasma concentrations of mannan-binding lectin (MBL), soluble membrane attack complex (sMAC), and C4b deposition were quantified in 71 patients with a recent acute coronary syndrome and glucose disturbances, randomly assigned to sitagliptin 100 mg (n = 34) or placebo (n = 37) for 12 weeks.
RESULTS


All the 7 DPP-4 inhibitors tested in the study directly inhibited functional activity of the lectin pathway in a dose-dependent manner with varying potency in vitro. In vivo, MBL, sMAC, and C4b declined significantly during follow-up in both groups without significant effect of sitagliptin.
CONCLUSIONS


We demonstrated an inhibitory effect of DPP-4 inhibitors on the lectin pathway in vitro. The clinical relevance of this effect of DPP-4 inhibitors remains to be fully elucidated.",2020,"Furthermore, plasma concentrations of mannan-binding lectin (MBL), soluble membrane attack complex (sMAC), and C4b deposition were quantified in 71 patients with a recent acute coronary syndrome and glucose disturbances, randomly assigned to sitagliptin 100 mg (n=34) or placebo (n=37) for 12 weeks.
","['diabetes', '71 patients with a recent acute coronary syndrome and glucose disturbances']","['DPP-4 inhibitors', 'Dipeptidyl peptidase-4 (DPP-4', 'placebo', 'dipeptidyl peptidase-4 inhibitors']","['Furthermore, plasma concentrations of mannan-binding lectin (MBL), soluble membrane attack complex (sMAC), and C4b deposition', 'MBL, sMAC, and C4b']","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}]","[{'cui': 'C1827106', 'cui_str': 'Dipeptidyl peptidase IV inhibitor'}, {'cui': 'C0081937', 'cui_str': 'Dipeptidyl peptidase IV'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0065661', 'cui_str': 'Mannose-binding protein'}, {'cui': 'C0009545', 'cui_str': 'Active C5b6789'}, {'cui': 'C0333562', 'cui_str': 'Deposition'}]",71.0,0.0519561,"Furthermore, plasma concentrations of mannan-binding lectin (MBL), soluble membrane attack complex (sMAC), and C4b deposition were quantified in 71 patients with a recent acute coronary syndrome and glucose disturbances, randomly assigned to sitagliptin 100 mg (n=34) or placebo (n=37) for 12 weeks.
","[{'ForeName': 'Ingeborg T', 'Initials': 'IT', 'LastName': 'Hoffmann-Petersen', 'Affiliation': 'Department of Internal Medicine, Regional Hospital of Northern Jutland, Hjørring, Denmark.'}, {'ForeName': 'Charlotte B', 'Initials': 'CB', 'LastName': 'Holt', 'Affiliation': 'Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Lisbeth', 'Initials': 'L', 'LastName': 'Jensen', 'Affiliation': 'Department of Biomedicine, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Hage', 'Affiliation': 'Cardiology Unit, Department of Medicine, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Linda G', 'Initials': 'LG', 'LastName': 'Mellbin', 'Affiliation': 'Cardiology Unit, Department of Medicine, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Thiel', 'Affiliation': 'Department of Biomedicine, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Troels K', 'Initials': 'TK', 'LastName': 'Hansen', 'Affiliation': 'Steno Diabetes Center Aarhus, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Jakob A', 'Initials': 'JA', 'LastName': 'Østergaard', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Aarhus, Denmark.'}]",Diabetes/metabolism research and reviews,['10.1002/dmrr.3385']
1284,32638017,"Randomized controlled Phase III trial to evaluate omentum preserving gastrectomy for patients with advanced gastric cancer (JCOG1711, ROAD-GC).","Gastrectomy with omentectomy and D2 lymph node dissection is the current standard procedure for locally advanced gastric cancer. However, some retrospective studies have reported that omentectomy increased post-operative abdominal complications but provided no survival advantage over omentum preservation. Therefore, we plan a randomized controlled phase III trial to confirm the non-inferiority of omentum preservation compared with omentectomy in patients with cT3 (SS) or cT4a (SE) gastric cancer. A total of 1050 patients will be enrolled from 62 institutions over a period of 6.5 years. The primary end point is relapse-free survival, and the secondary end points are overall survival, blood loss, operation time and adverse events. This trial has been registered at the UMIN Clinical Trials Registry as UMIN000036253.",2020,"The primary end point is relapse-free survival, and the secondary end points are overall survival, blood loss, operation time and adverse events.","['patients with advanced gastric cancer (JCOG1711, ROAD-GC', 'locally advanced gastric cancer', '1050 patients will be enrolled from 62 institutions over a period of 6.5\xa0years', 'patients with cT3 (SS) or cT4a (SE) gastric cancer']","['omentum preserving gastrectomy', 'Gastrectomy with omentectomy and D2 lymph node dissection']","['relapse-free survival', 'overall survival, blood loss, operation time and adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0442650', 'cui_str': 'Road'}, {'cui': 'C4517528', 'cui_str': '1050'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1175872', 'cui_str': 'CAGE1 protein, human'}]","[{'cui': 'C0028977', 'cui_str': 'Omental'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0017118', 'cui_str': 'Gastrectomy'}, {'cui': 'C0198614', 'cui_str': 'Omentectomy'}, {'cui': 'C2960517', 'cui_str': 'D2 lymph node dissection'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",1050.0,0.162456,"The primary end point is relapse-free survival, and the secondary end points are overall survival, blood loss, operation time and adverse events.","[{'ForeName': 'Yuya', 'Initials': 'Y', 'LastName': 'Sato', 'Affiliation': 'JCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo.'}, {'ForeName': 'Takanobu', 'Initials': 'T', 'LastName': 'Yamada', 'Affiliation': 'Department of Gastrointestinal Surgery, Kanagawa Cancer Center, Kanagawa.'}, {'ForeName': 'Takaki', 'Initials': 'T', 'LastName': 'Yoshikawa', 'Affiliation': 'Gastric Surgery Division, National Cancer Center Hospital, Tokyo.'}, {'ForeName': 'Ryunosuke', 'Initials': 'R', 'LastName': 'Machida', 'Affiliation': 'JCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo.'}, {'ForeName': 'Junki', 'Initials': 'J', 'LastName': 'Mizusawa', 'Affiliation': 'JCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Katayama', 'Affiliation': 'JCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo.'}, {'ForeName': 'Masanori', 'Initials': 'M', 'LastName': 'Tokunaga', 'Affiliation': 'Department of Gastrointestinal Surgery, Tokyo Medical and Dental University, Tokyo.'}, {'ForeName': 'Narikazu', 'Initials': 'N', 'LastName': 'Boku', 'Affiliation': 'Division of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo.'}, {'ForeName': 'Masanori', 'Initials': 'M', 'LastName': 'Terashima', 'Affiliation': 'Department of Gastric Surgery, Shizuoka Cancer Center, Shizuoka, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Japanese journal of clinical oncology,['10.1093/jjco/hyaa113']
1285,32640945,High-Sensitivity Cardiac Troponin T for Risk Stratification in Patients With Embolic Stroke of Undetermined Source.,"BACKGROUND AND PURPOSE


Optimal secondary prevention for patients with embolic stroke of undetermined source (ESUS) remains unknown. We aimed to assess whether high-sensitivity cardiac troponin T (hs-cTnT) levels are associated with major vascular events and whether hs-cTnT may identify patients who benefit from anticoagulation following ESUS.
METHODS


Data were obtained from the biomarker substudy of the NAVIGATE ESUS trial, a randomized controlled trial testing the efficacy of rivaroxaban versus aspirin for secondary stroke prevention in ESUS. Patients were dichotomized at the hs-cTnT upper reference limit (14 ng/L, Gen V, Roche Diagnostics). Cox proportional hazard models were computed to explore the association between hs-cTnT, the combined cardiovascular end point (recurrent stroke, myocardial infarction, systemic embolism, cardiovascular death), and recurrent ischemic stroke.
RESULTS


Among 1337 patients enrolled at 111 participating centers in 18 countries (mean age 67±9 years, 61% male), hs-cTnT was detectable in 95% and at/above the upper reference limit in 21%. During a median follow-up of 11 months, the combined cardiovascular end point occurred in 68 patients (5.0%/y, rivaroxaban 28 events, aspirin 40 events; hazard ratio, 0.67 [95% CI, 0.41-1.1]), and recurrent ischemic stroke occurred in 50 patients (4.0%/y, rivaroxaban 16 events, aspirin 34 events, hazard ratio 0.45 [95% CI, 0.25-0.81]). Annualized combined cardiovascular end point rates were 8.2% (9.5% rivaroxaban, 7.0% aspirin) for those above hs-cTnT upper reference limit and 4.8% (3.1% rivaroxaban, 6.6% aspirin) below with a significant treatment modification ( P =0.04). Annualized ischemic stroke rates were 4.7% above hs-cTnT upper reference limit and 3.9% below, with no suggestion of an interaction between hs-cTnT and treatment ( P =0.3).
CONCLUSIONS


In patients with ESUS, hs-cTnT was associated with increased cardiovascular event rates. While fewer recurrent strokes occurred in patients receiving rivaroxaban, outcomes were not stratified by hs-cTn results. Our findings support using hs-cTnT for cardiovascular risk stratification but not for decision-making regarding anticoagulation therapy in patients with ESUS. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02313909.",2020,"In patients with ESUS, hs-cTnT was associated with increased cardiovascular event rates.","['secondary stroke prevention in ESUS', '1337 patients enrolled at 111 participating centers in 18 countries (mean age 67±9 years, 61% male), hs-cTnT was detectable in 95% and at/above the upper reference limit in 21', 'patients with ESUS', 'patients with embolic stroke of undetermined source (ESUS', 'patients who benefit from anticoagulation following ESUS', 'Patients With Embolic Stroke of Undetermined Source']","['rivaroxaban', 'High-Sensitivity Cardiac Troponin T', 'rivaroxaban versus aspirin']","['combined cardiovascular end point (recurrent stroke, myocardial infarction, systemic embolism, cardiovascular death), and recurrent ischemic stroke', 'cardiovascular event rates', 'Annualized combined cardiovascular end point rates', 'recurrent strokes', 'recurrent ischemic stroke', 'Annualized ischemic stroke rates']","[{'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1277289', 'cui_str': 'Stroke prevention'}, {'cui': 'C3888970', 'cui_str': 'Embolic stroke of undetermined source'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0523953', 'cui_str': 'Troponin T cardiac measurement'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0523953', 'cui_str': 'Troponin T cardiac measurement'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C1836785', 'cui_str': 'Recurrent stroke'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013922', 'cui_str': 'Embolism'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",1337.0,0.250989,"In patients with ESUS, hs-cTnT was associated with increased cardiovascular event rates.","[{'ForeName': 'Jan F', 'Initials': 'JF', 'LastName': 'Scheitz', 'Affiliation': 'Center for Stroke Research Berlin, Charité-Universitätsmedizin Berlin, Germany (J.F.S., C.H.N., M.E.).'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Pare', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, ON, Canada (G.P.).'}, {'ForeName': 'Lesly A', 'Initials': 'LA', 'LastName': 'Pearce', 'Affiliation': 'Biostatistics Consultant, Minot, ND (L.A.P.).'}, {'ForeName': 'Hardi', 'Initials': 'H', 'LastName': 'Mundl', 'Affiliation': 'Bayer AG, Wuppertal, Germany (H.M., T.K.).'}, {'ForeName': 'W Frank', 'Initials': 'WF', 'LastName': 'Peacock', 'Affiliation': 'Baylor College of Medicine, Houston, TX (W.F.P.).'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Czlonkowska', 'Affiliation': '2nd Department of Neurology, Institute of Psychiatry and Neurology, Warsaw, Poland (A.C.).'}, {'ForeName': 'Mukul', 'Initials': 'M', 'LastName': 'Sharma', 'Affiliation': 'Department of Medicine (Neurology), Population Health Research Institute, McMaster University, Hamilton Health Sciences, Canada (M.S., A.S.).'}, {'ForeName': 'Christian H', 'Initials': 'CH', 'LastName': 'Nolte', 'Affiliation': 'Center for Stroke Research Berlin, Charité-Universitätsmedizin Berlin, Germany (J.F.S., C.H.N., M.E.).'}, {'ForeName': 'Ashkan', 'Initials': 'A', 'LastName': 'Shoamanesh', 'Affiliation': 'Department of Medicine (Neurology), Population Health Research Institute, McMaster University, Hamilton Health Sciences, Canada (M.S., A.S.).'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Berkowitz', 'Affiliation': 'Research & Development, Pharmaceuticals, Bayer U.S., LLC, Whippany (S.D.B.).'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Krahn', 'Affiliation': 'Bayer AG, Wuppertal, Germany (H.M., T.K.).'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Endres', 'Affiliation': 'Center for Stroke Research Berlin, Charité-Universitätsmedizin Berlin, Germany (J.F.S., C.H.N., M.E.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Stroke,['10.1161/STROKEAHA.120.029628']
1286,32646282,"Effects of judo training upon body composition, autonomic function, and cardiorespiratory fitness in overweight or obese children aged 8- to 13 years.","Physical training is recommended for obese paediatric populations. We investigated the effects of recreational judo training (JT) upon body composition and distribution, cardiorespiratory fitness, and heart rate variability (HRV) in overweight or obese children. A controlled trial (RBR-9d94td) was conducted with 35 children (8-13 years) assigned into groups according to their body mass index (BMI): eutrophic (EU; n = 15; z-BMI ≤ +l and ≥ -2) and overweight or obese (OB; n = 20; z-BMI > +1 and ≤ +3). The 12-week JT included 60-min sessions performed 2 times/week at 65-75% maximal heart rate (HR). BMI, waist circumference, blood pressure, HRV, peak oxygen uptake (VO 2peak ), gas exchange threshold (GET), and body fractioning were assessed. Significant reductions in OB (P < 0.05) occurred for whole body and trunk fat (~3%), trunk/limb fat-ratio (~4%), resting HR (~3%), and sympathovagal balance (log LF:HF, ~85%). Increases (P < 0.05) occurred in lean mass (~8%), parasympathetic modulation (log HF, ~4%), VO 2peak  (~5-10%), and VO 2  (~15%), speed (~10%) and slope (~13%) at GET. Markers of cardiorespiratory fitness (relative VO 2 , slope and speed at GET) in OB approached EU after JT. In conclusion, a relatively short JT intervention to improved body composition, autonomic modulation, and physical fitness in obese children.",2020,"Significant reductions in OB (P < 0.05) occurred for whole body and trunk fat (~3%), trunk/limb fat-ratio (~4%), resting HR (~3%), and sympathovagal balance (log LF:HF, ~85%).","['obese children', '35 children (8-13\xa0years) assigned into groups according to their', '2) and overweight or obese (OB; n =\xa020; z-BMI > +1 and ≤ +3', 'overweight or obese children aged 8- to 13 years', 'obese paediatric populations', 'overweight or obese children']","['recreational judo training (JT', 'Physical training', 'judo training', 'JT intervention', 'body mass index (BMI): eutrophic (EU; n =\xa015; z-BMI ≤ +l and ≥']","['body composition and distribution, cardiorespiratory fitness, and heart rate variability (HRV', 'BMI, waist circumference, blood pressure, HRV, peak oxygen uptake (VO 2peak ), gas exchange threshold (GET), and body fractioning', 'lean mass', 'body composition, autonomic function, and cardiorespiratory fitness', 'cardiorespiratory fitness (relative VO 2 , slope and speed at GET', 'sympathovagal balance', 'OB', 'parasympathetic modulation', 'body composition, autonomic modulation, and physical fitness']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0079650', 'cui_str': 'Judo'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}]",35.0,0.0188821,"Significant reductions in OB (P < 0.05) occurred for whole body and trunk fat (~3%), trunk/limb fat-ratio (~4%), resting HR (~3%), and sympathovagal balance (log LF:HF, ~85%).","[{'ForeName': 'Iedda', 'Initials': 'I', 'LastName': 'Brasil', 'Affiliation': 'Laboratory of Physical Activity and Health Promotion, University of Rio de Janeiro State , Rio de Janeiro, Brazil.'}, {'ForeName': 'Walace', 'Initials': 'W', 'LastName': 'Monteiro', 'Affiliation': 'Laboratory of Physical Activity and Health Promotion, University of Rio de Janeiro State , Rio de Janeiro, Brazil.'}, {'ForeName': 'Tainah', 'Initials': 'T', 'LastName': 'Lima', 'Affiliation': 'Laboratory of Physical Activity and Health Promotion, University of Rio de Janeiro State , Rio de Janeiro, Brazil.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Seabra', 'Affiliation': 'Research Centre in Physical Activity, Health and Leisure, Faculty of Sport, University of Porto , Porto, Portugal.'}, {'ForeName': 'Paulo', 'Initials': 'P', 'LastName': 'Farinatti', 'Affiliation': 'Laboratory of Physical Activity and Health Promotion, University of Rio de Janeiro State , Rio de Janeiro, Brazil.'}]",Journal of sports sciences,['10.1080/02640414.2020.1792189']
1287,32640940,Impact of Goal-Directed Therapy on Delayed Ischemia After Aneurysmal Subarachnoid Hemorrhage: Randomized Controlled Trial.,"BACKGROUND AND PURPOSE


Delayed cerebral ischemia (DCI) is the most important cause for a poor clinical outcome after a subarachnoid hemorrhage. The aim of this study was to assess whether goal-directed hemodynamic therapy (GDHT), as compared to standard clinical care, reduces the rate of DCI after subarachnoid hemorrhage.
METHODS


We conducted a prospective randomized controlled trial. Patients >18 years of age with an aneurysmal subarachnoid hemorrhage were enrolled and randomly assigned to standard therapy or GDHT. Advanced hemodynamic monitoring and predefined GDHT algorithms were applied in the GDHT group. The primary end point was the occurrence of DCI. Functional outcome was assessed using the Glasgow Outcome Scale (GOS) 3 months after discharge.
RESULTS


In total, 108 patients were randomized to the control (n=54) or GDHT group (n=54). The primary outcome (DCI) occurred in 13% of the GDHT group and in 32% of the control group patients (odds ratio, 0.324 [95% CI, 0.11-0.86];  P =0.021). Even after adjustment for confounding parameters, GDHT was found to be superior to standard therapy (hazard ratio, 2.84 [95% CI, 1.18-6.86];  P =0.02). The GOS was assessed 3 months after discharge in 107 patients; it showed more patients with a low disability (GOS 5, minor or no deficits) than patients with higher deficits (GOS 1-4) in the GDHT group compared with the control group (GOS 5, 66% versus 44%; GOS 1-4, 34% versus 56%;  P =0.025). There was no significant difference in mortality between the groups.
CONCLUSIONS


GDHT reduced the rate of DCI after subarachnoid hemorrhage with a better functional outcome (GOS=5) 3 months after discharge. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01832389.",2020,"Even after adjustment for confounding parameters, GDHT was found to be superior to standard therapy (hazard ratio, 2.84 [95% CI, 1.18-6.86];  P =0.02).","['108 patients', 'After Aneurysmal Subarachnoid Hemorrhage', 'Patients >18 years of age with an aneurysmal subarachnoid hemorrhage']","['standard therapy or GDHT', 'GDHT', 'goal-directed hemodynamic therapy (GDHT', 'Goal-Directed Therapy']","['rate of DCI after subarachnoid hemorrhage', 'GOS', 'Glasgow Outcome Scale (GOS', 'occurrence of DCI', 'mortality', 'Delayed Ischemia']","[{'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0751530', 'cui_str': 'Subarachnoid Hemorrhage, Aneurysmal'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1271494', 'cui_str': 'Goal directed therapy'}]","[{'cui': 'C4761225', 'cui_str': 'Delayed cerebral ischaemia'}, {'cui': 'C0038525', 'cui_str': 'Subarachnoid hemorrhage'}, {'cui': 'C0701887', 'cui_str': 'Glasgow outcome scale'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}]",108.0,0.182296,"Even after adjustment for confounding parameters, GDHT was found to be superior to standard therapy (hazard ratio, 2.84 [95% CI, 1.18-6.86];  P =0.02).","[{'ForeName': 'Aida', 'Initials': 'A', 'LastName': 'Anetsberger', 'Affiliation': 'Department of Anesthesiology (A.A., M.B., R.B., M.H., G.S., S.S., J.S., J.M., M.E., B.J.), Klinikum rechts der Isar, Technical University Munich, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Gempt', 'Affiliation': 'Department of Neurosurgery (J.G., F.R., B.M., Y.-M.R., M.W.), Klinikum rechts der Isar, Technical University Munich, Germany.'}, {'ForeName': 'Manfred', 'Initials': 'M', 'LastName': 'Blobner', 'Affiliation': 'Department of Anesthesiology (A.A., M.B., R.B., M.H., G.S., S.S., J.S., J.M., M.E., B.J.), Klinikum rechts der Isar, Technical University Munich, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Ringel', 'Affiliation': 'Department of Neurosurgery (J.G., F.R., B.M., Y.-M.R., M.W.), Klinikum rechts der Isar, Technical University Munich, Germany.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Bogdanski', 'Affiliation': 'Department of Anesthesiology (A.A., M.B., R.B., M.H., G.S., S.S., J.S., J.M., M.E., B.J.), Klinikum rechts der Isar, Technical University Munich, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Heim', 'Affiliation': 'Department of Anesthesiology (A.A., M.B., R.B., M.H., G.S., S.S., J.S., J.M., M.E., B.J.), Klinikum rechts der Isar, Technical University Munich, Germany.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Schneider', 'Affiliation': 'Department of Anesthesiology (A.A., M.B., R.B., M.H., G.S., S.S., J.S., J.M., M.E., B.J.), Klinikum rechts der Isar, Technical University Munich, Germany.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Meyer', 'Affiliation': 'Department of Neurosurgery (J.G., F.R., B.M., Y.-M.R., M.W.), Klinikum rechts der Isar, Technical University Munich, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Schmid', 'Affiliation': 'Department of Anesthesiology (A.A., M.B., R.B., M.H., G.S., S.S., J.S., J.M., M.E., B.J.), Klinikum rechts der Isar, Technical University Munich, Germany.'}, {'ForeName': 'Yu-Mi', 'Initials': 'YM', 'LastName': 'Ryang', 'Affiliation': 'Department of Neurosurgery (J.G., F.R., B.M., Y.-M.R., M.W.), Klinikum rechts der Isar, Technical University Munich, Germany.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Wostrack', 'Affiliation': 'Department of Neurosurgery (J.G., F.R., B.M., Y.-M.R., M.W.), Klinikum rechts der Isar, Technical University Munich, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Schneider', 'Affiliation': 'Department of Anesthesiology (A.A., M.B., R.B., M.H., G.S., S.S., J.S., J.M., M.E., B.J.), Klinikum rechts der Isar, Technical University Munich, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Martin', 'Affiliation': 'Department of Anesthesiology (A.A., M.B., R.B., M.H., G.S., S.S., J.S., J.M., M.E., B.J.), Klinikum rechts der Isar, Technical University Munich, Germany.'}, {'ForeName': 'Maximilian', 'Initials': 'M', 'LastName': 'Ehrhardt', 'Affiliation': 'Department of Anesthesiology (A.A., M.B., R.B., M.H., G.S., S.S., J.S., J.M., M.E., B.J.), Klinikum rechts der Isar, Technical University Munich, Germany.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Jungwirth', 'Affiliation': 'Department of Anesthesiology (A.A., M.B., R.B., M.H., G.S., S.S., J.S., J.M., M.E., B.J.), Klinikum rechts der Isar, Technical University Munich, Germany.'}]",Stroke,['10.1161/STROKEAHA.120.029279']
1288,32645143,Smell-Based Memory Training: Evidence of Olfactory Learning and Transfer to the Visual Domain.,"Human and non-human animal research converge to suggest that the sense of smell, olfaction, has a high level of plasticity and is intimately associated with visual-spatial orientation and memory encoding networks. We investigated whether olfactory memory (OM) training would lead to transfer to an untrained visual memory (VM) task, as well as untrained olfactory tasks. We devised a memory intervention to compare transfer effects generated by olfactory and non-olfactory (visual) memory training. Adult participants were randomly assigned to daily memory training for about 40 days with either olfactory or visual tasks that had a similar difficulty level. Results showed that while visual training did not produce transfer to the OM task, olfactory training produced transfer to the untrained VM task. Olfactory training also improved participants' performance on odor discrimination and naming tasks, such that they reached the same performance level as a high-performing group of wine professionals. Our results indicate that the olfactory system is highly responsive to training, and we speculate that the sense of smell may facilitate transfer of learning to other sensory domains. Further research is however needed in order to replicate and extend our findings.",2020,"Results showed that while visual training did not produce transfer to the olfactory memory task, olfactory training produced transfer to the untrained visual memory task.",['Adult participants'],"['olfactory memory training', 'olfactory and non-olfactory (visual) memory training', 'Smell-based memory training', 'Olfactory training', 'daily memory training']","['olfactory memory task, olfactory training produced transfer to the untrained visual memory task', ""participants' performance on odor discrimination and naming tasks""]","[{'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0037361', 'cui_str': 'Sense of smell, function'}, {'cui': 'C0729377', 'cui_str': 'Memory skills training'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0037361', 'cui_str': 'Sense of smell, function'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0542316', 'cui_str': 'Visual memory'}, {'cui': 'C0028884', 'cui_str': 'With odor'}, {'cui': 'C0012632', 'cui_str': 'Cognitive discrimination'}]",,0.0220731,"Results showed that while visual training did not produce transfer to the olfactory memory task, olfactory training produced transfer to the untrained visual memory task.","[{'ForeName': 'Jonas K', 'Initials': 'JK', 'LastName': 'Olofsson', 'Affiliation': 'Gösta Ekman Laboratory, Department of Psychology, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Ekström', 'Affiliation': 'Gösta Ekman Laboratory, Department of Psychology, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Lindström', 'Affiliation': 'Gösta Ekman Laboratory, Department of Psychology, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Elmeri', 'Initials': 'E', 'LastName': 'Syrjänen', 'Affiliation': 'Gösta Ekman Laboratory, Department of Psychology, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Stigsdotter-Neely', 'Affiliation': 'Department of Social and Psychological Studies, Karlstad University, Karlstad, Sweden.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Nyberg', 'Affiliation': 'Umeå Center for Functional Brain Imaging, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Jonsson', 'Affiliation': 'Gösta Ekman Laboratory, Department of Psychology, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Larsson', 'Affiliation': 'Gösta Ekman Laboratory, Department of Psychology, Stockholm University, Stockholm, Sweden.'}]",Chemical senses,['10.1093/chemse/bjaa049']
1289,32652012,A Chicken Production Intervention and Additional Nutrition Behavior Change Component Increased Child Growth in Ethiopia: A Cluster-Randomized Trial.,"BACKGROUND


Chicken production in the context of nutrition-sensitive agriculture may benefit child nutrition in low-income settings.
OBJECTIVES


This study evaluated effects of 1) a chicken production intervention [African Chicken Genetic Gains (ACGG)], and 2) the ACGG intervention with nutrition-sensitive behavior change communication (BCC) [ACGG + Agriculture to Nutrition (ATONU)], on child nutrition and health outcomes and hypothesized intermediaries.
METHODS


Forty ACGG villages received 25 genetically improved chickens and basic husbandry guidance; of these, 20 ACGG + ATONU villages in addition received a nutrition-sensitive behavior change and homegardening intervention; 20 control clusters received no intervention. We assessed effects of the interventions on height-for-age z scores (HAZ), weight-for-age z scores (WAZ), and weight-for-height z scores (WHZ) at 9 (midline) and 18 mo (endline) through unadjusted and adjusted ordinary least squares (OLS) regressions. We examined the interventions' effects on hypothesized intermediaries including egg production and consumption, dietary diversity, women's empowerment, income, child morbidities, anemia, and chicken management practices through OLS and log binomial models.
RESULTS


Data included 829 children aged 0-36 mo at baseline. ACGG + ATONU children had higher midline HAZ [mean difference (MD): 0.28; 95% CI: 0.02, 0.54] than controls. The ACGG group had higher HAZ (MD: 0.28; 95% CI: 0.05, 0.50) and higher WAZ (MD: 0.18; 95% CI: 0.01, 0.36) at endline than controls; after adjusting for potential baseline imbalance, effects were similar but not statistically significant. At endline, differences in ACGG + ATONU children's HAZ and WAZ compared with controls were similar in magnitude to those of ACGG, but not statistically significant. There were no differences in anthropometry between the intervention groups. ACGG + ATONU children had higher dietary diversity and egg consumption than ACGG children at endline. Both interventions showed improvements in chicken management practices. The interventions did not increase anemia, diarrhea, fever, or vomiting, and the ACGG + ATONU group at midline showed reduced risk of fever.
CONCLUSIONS


A chicken production intervention with or without nutrition-sensitive BCC may have benefited child nutrition and did not increase morbidity.This trial was registered at clinicaltrials.gov as NCT03152227.",2020,"The ACGG group had higher HAZ (MD: 0.28; 95% CI: 0.05, 0.50) and higher WAZ (MD: 0.18; 95% CI: 0.01, 0.36) at endline than controls; after adjusting for potential baseline imbalance, effects were similar but not statistically significant.","['Increased Child Growth in Ethiopia', 'Forty ACGG villages received 25 genetically improved chickens and basic husbandry guidance; of these, 20\xa0ACGG\xa0+\xa0ATONU villages in addition received a', '829 children aged 0-36 mo at baseline']","['nutrition-sensitive behavior change and homegardening intervention; 20 control clusters received no intervention', 'Chicken Production Intervention and Additional Nutrition Behavior Change Component', 'chicken production intervention [African Chicken Genetic Gains (ACGG', 'ACGG intervention with nutrition-sensitive behavior change communication (BCC) [ACGG\xa0+ Agriculture to Nutrition (ATONU']","['anemia, diarrhea, fever, or vomiting', 'chicken management practices', 'height-for-age z scores (HAZ), weight-for-age z scores (WAZ), and weight-for-height z scores (WHZ', 'risk of fever', ""egg production and consumption, dietary diversity, women's empowerment, income, child morbidities, anemia, and chicken management practices through OLS and log binomial models"", 'morbidity']","[{'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0015024', 'cui_str': 'Ethiopia'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0008051', 'cui_str': 'Gallus gallus'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]","[{'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0008051', 'cui_str': 'Gallus gallus'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C0017296', 'cui_str': 'Gene therapy'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0001829', 'cui_str': 'Farming'}]","[{'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0008051', 'cui_str': 'Gallus gallus'}, {'cui': 'C0600585', 'cui_str': 'Practice Management'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0424670', 'cui_str': 'Weight for height'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0013710', 'cui_str': 'Eggs (edible)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0023189', 'cui_str': 'Analysis, Least-Squares'}, {'cui': 'C0026338', 'cui_str': 'Models, Binomial'}]",829.0,0.130307,"The ACGG group had higher HAZ (MD: 0.28; 95% CI: 0.05, 0.50) and higher WAZ (MD: 0.18; 95% CI: 0.01, 0.36) at endline than controls; after adjusting for potential baseline imbalance, effects were similar but not statistically significant.","[{'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Passarelli', 'Affiliation': 'Department of Nutrition, Harvard TH Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Ramya', 'Initials': 'R', 'LastName': 'Ambikapathi', 'Affiliation': 'Department of Public Health, Purdue University, West Lafayette, IN, USA.'}, {'ForeName': 'Nilupa S', 'Initials': 'NS', 'LastName': 'Gunaratna', 'Affiliation': 'Department of Public Health, Purdue University, West Lafayette, IN, USA.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Madzorera', 'Affiliation': 'Department of Nutrition, Harvard TH Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Chelsey R', 'Initials': 'CR', 'LastName': 'Canavan', 'Affiliation': 'Department of Nutrition, Harvard TH Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Abdallah R', 'Initials': 'AR', 'LastName': 'Noor', 'Affiliation': 'Department of Nutrition, Harvard TH Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Amare', 'Initials': 'A', 'LastName': 'Worku', 'Affiliation': 'Addis Continental Institute of Public Health, Addis Ababa, Ethiopia.'}, {'ForeName': 'Yemane', 'Initials': 'Y', 'LastName': 'Berhane', 'Affiliation': 'Addis Continental Institute of Public Health, Addis Ababa, Ethiopia.'}, {'ForeName': 'Semira', 'Initials': 'S', 'LastName': 'Abdelmenan', 'Affiliation': 'Addis Continental Institute of Public Health, Addis Ababa, Ethiopia.'}, {'ForeName': 'Simbarashe', 'Initials': 'S', 'LastName': 'Sibanda', 'Affiliation': 'Food, Agriculture and Natural Resources Policy Analysis Network, Pretoria, South Africa.'}, {'ForeName': 'Bertha', 'Initials': 'B', 'LastName': 'Munthali', 'Affiliation': 'Food, Agriculture and Natural Resources Policy Analysis Network, Pretoria, South Africa.'}, {'ForeName': 'Tshilidzi', 'Initials': 'T', 'LastName': 'Madzivhandila', 'Affiliation': 'Food, Agriculture and Natural Resources Policy Analysis Network, Pretoria, South Africa.'}, {'ForeName': 'Lindiwe M', 'Initials': 'LM', 'LastName': 'Sibanda', 'Affiliation': 'Food, Agriculture and Natural Resources Policy Analysis Network, Pretoria, South Africa.'}, {'ForeName': 'Kumlachew', 'Initials': 'K', 'LastName': 'Geremew', 'Affiliation': 'International Livestock Research Institute, Addis Ababa, Ethiopia.'}, {'ForeName': 'Tadelle', 'Initials': 'T', 'LastName': 'Dessie', 'Affiliation': 'International Livestock Research Institute, Addis Ababa, Ethiopia.'}, {'ForeName': 'Solomon', 'Initials': 'S', 'LastName': 'Abegaz', 'Affiliation': 'Ethiopian Institute of Agricultural Research, Addis Ababa, Ethiopia.'}, {'ForeName': 'Getnet', 'Initials': 'G', 'LastName': 'Assefa', 'Affiliation': 'Ethiopian Institute of Agricultural Research, Addis Ababa, Ethiopia.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Sudfeld', 'Affiliation': 'Department of Global Health and Population, Harvard TH Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'McConnell', 'Affiliation': 'Department of Global Health and Population, Harvard TH Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Davison', 'Affiliation': 'Boston College School of Social Work, Boston, MA, USA.'}, {'ForeName': 'Wafaie', 'Initials': 'W', 'LastName': 'Fawzi', 'Affiliation': 'Department of Global Health and Population, Harvard TH Chan School of Public Health, Boston, MA, USA.'}]",The Journal of nutrition,['10.1093/jn/nxaa181']
1290,31818048,Comparison of Effectiveness between Abdominal Vibration Stimulation and Walking Exercise for Bowel Cleansing before Therapeutic Colonoscopy.,"Background/Aims


Adequate bowel preparation is important for successful colonoscopy. We aimed to evaluate the clinical feasibility and effectiveness of abdominal vibration stimulation in bowel preparation before therapeutic colonoscopy.
Methods


A single center, prospective, randomized, investigator-blinded study was performed between January 2016 and December 2016. Patients for therapeutic colonoscopy were prospectively enrolled and assigned to either the vibrator group or walking group. Patients who refused to participate in this study as part of the experimental group consented to register in the control group instead. During the preparation period, patients assigned to the walking group walked ≥3,000 steps, whereas those assigned to the vibrator group received abdominal vibrator stimulation and restricted walking. All patients received the same colon cleansing regimen: 4-L split-dose polyethylene glycol (PEG) solution.
Results


Three hundred patients who received PEG solution for therapeutic colonoscopy were finally enrolled in this study (n=100 per group). Bowel cleansing with abdominal vibration stimulation showed almost similar results to that with walking exercise (Boston Bowel Preparation Scale score for the entire colon: vibrator vs walking vs control, 7.38±1.55 vs 7.39±1.55 vs 6.17±1.15, p<0.001). There were no significant differences between the vibrator group and walking group regarding instances of diarrhea after taking PEG, time to first diarrhea after taking PEG, total procedure time, and patient satisfaction.
Conclusions


This study indicates that, compared with conventional walking exercise, abdominal vibration stimulation achieved similar rates of bowel cleansing adequacy and colonoscopy success without compromising safety or patient satisfaction.",2020,"There were no significant differences between the vibrator group and walking group regarding instances of diarrhea after taking PEG, time to first diarrhea after taking PEG, total procedure time, and patient satisfaction.
","['January 2016 and December 2016', 'Patients who refused to participate in this study as part of the experimental group consented to register in the control group instead', 'Patients for therapeutic colonoscopy', 'Three hundred patients who received']","['PEG solution', 'vibrator group or walking group', 'Abdominal Vibration Stimulation and Walking Exercise', 'conventional walking exercise, abdominal vibration stimulation', 'vibrator group received abdominal vibrator stimulation and restricted walking', 'same colon cleansing regimen: 4-L split-dose polyethylene glycol (PEG) solution', 'abdominal vibration stimulation']","['walking exercise (Boston Bowel Preparation Scale score', 'diarrhea after taking PEG, time to first diarrhea after taking PEG, total procedure time, and patient satisfaction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1136454', 'cui_str': 'Refusal to Participate'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0554063', 'cui_str': 'Therapeutic colonoscopy'}, {'cui': 'C4319604', 'cui_str': '300'}]","[{'cui': 'C0032483', 'cui_str': 'Polyethylene Glycols'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0184304', 'cui_str': 'Vibrator'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0009368', 'cui_str': 'Colonic'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4302285', 'cui_str': 'BBPS - Boston bowel preparation scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0032483', 'cui_str': 'Polyethylene Glycols'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}]",300.0,0.0410102,"There were no significant differences between the vibrator group and walking group regarding instances of diarrhea after taking PEG, time to first diarrhea after taking PEG, total procedure time, and patient satisfaction.
","[{'ForeName': 'Choong-Kyun', 'Initials': 'CK', 'LastName': 'Noh', 'Affiliation': 'Departments of Gastroenterology, Ajou University School of Medicine, Suwon, Korea.'}, {'ForeName': 'In Sung', 'Initials': 'IS', 'LastName': 'Kim', 'Affiliation': 'Departments of Gastroenterology, Ajou University School of Medicine, Suwon, Korea.'}, {'ForeName': 'Gil Ho', 'Initials': 'GH', 'LastName': 'Lee', 'Affiliation': 'Departments of Gastroenterology, Ajou University School of Medicine, Suwon, Korea.'}, {'ForeName': 'Jin Woong', 'Initials': 'JW', 'LastName': 'Park', 'Affiliation': 'Departments of Gastroenterology, Ajou University School of Medicine, Suwon, Korea.'}, {'ForeName': 'Eunyoung', 'Initials': 'E', 'LastName': 'Lee', 'Affiliation': 'Departments of Biomedical Informatics, Ajou University School of Medicine, Suwon, Korea.'}, {'ForeName': 'Bumhee', 'Initials': 'B', 'LastName': 'Park', 'Affiliation': 'Departments of Biomedical Informatics, Ajou University School of Medicine, Suwon, Korea.'}, {'ForeName': 'Hye Jeon', 'Initials': 'HJ', 'LastName': 'Hong', 'Affiliation': 'General Ward Nursing Unit, Ajou University Medical Center, Suwon, Korea.'}, {'ForeName': 'Sun Gyo', 'Initials': 'SG', 'LastName': 'Lim', 'Affiliation': 'Departments of Gastroenterology, Ajou University School of Medicine, Suwon, Korea.'}, {'ForeName': 'Sung Jae', 'Initials': 'SJ', 'LastName': 'Shin', 'Affiliation': 'Departments of Gastroenterology, Ajou University School of Medicine, Suwon, Korea.'}, {'ForeName': 'Jin Hong', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Departments of Gastroenterology, Ajou University School of Medicine, Suwon, Korea.'}, {'ForeName': 'Kee Myung', 'Initials': 'KM', 'LastName': 'Lee', 'Affiliation': 'Departments of Gastroenterology, Ajou University School of Medicine, Suwon, Korea.'}]",Gut and liver,['10.5009/gnl19999']
1291,32661293,Competitiveness and individual characteristics: a double-blind placebo-controlled study using oxytocin.,"Oxytocin-enhanced prosocial behaviour depends on individual characteristics. This study investigated the relationship between oxytocin and competitiveness, which is another important social trait and predicts economic and social outcomes. In this double-blind, randomized, and placebo-controlled study of 192 male participants, we examined whether oxytocin moderates competitiveness and whether the effect of oxytocin on competitiveness is amplified in individuals with autistic traits. While our results show no relationship between oxytocin and competitiveness, we observed suggestive patterns: albeit not significantly, oxytocin reduced and enhanced competitiveness among participants without autistic traits and among their counterparts with autistic traits, respectively.",2020,"While our results show no relationship between oxytocin and competitiveness, we observed suggestive patterns: albeit not significantly, oxytocin reduced and enhanced competitiveness among participants without autistic traits and among their counterparts with autistic traits, respectively.","['192 male participants', 'individuals with autistic traits']","['oxytocin', 'Oxytocin', 'placebo']",[],"[{'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],192.0,0.277588,"While our results show no relationship between oxytocin and competitiveness, we observed suggestive patterns: albeit not significantly, oxytocin reduced and enhanced competitiveness among participants without autistic traits and among their counterparts with autistic traits, respectively.","[{'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Kurokawa', 'Affiliation': 'School of Economics and Management, University of Hyogo, 8-2-1 Gakuen-nishi-machi, Nishi-ku, Kobe, Hyogo, 651-2197, Japan. kurokawa@em.u-hyogo.ac.jp.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Kinari', 'Affiliation': 'Hirao School of Management, Konan University, Nishinomiya, Hyogo, Japan.'}, {'ForeName': 'Hiroko', 'Initials': 'H', 'LastName': 'Okudaira', 'Affiliation': 'Doshisha Business School, Doshisha University, Kyoto, Kyoto, Japan.'}, {'ForeName': 'Kiyotaka', 'Initials': 'K', 'LastName': 'Tsubouchi', 'Affiliation': 'Department of Biophysical Genetics, Research Center for Child Mental Development, Kanazawa University, Kanazawa, Japan.'}, {'ForeName': 'Yoshimichi', 'Initials': 'Y', 'LastName': 'Sai', 'Affiliation': 'Department of Biophysical Genetics, Research Center for Child Mental Development, Kanazawa University, Kanazawa, Japan.'}, {'ForeName': 'Mitsuru', 'Initials': 'M', 'LastName': 'Kikuchi', 'Affiliation': 'Department of Biophysical Genetics, Research Center for Child Mental Development, Kanazawa University, Kanazawa, Japan.'}, {'ForeName': 'Haruhiro', 'Initials': 'H', 'LastName': 'Higashida', 'Affiliation': 'Department of Biophysical Genetics, Research Center for Child Mental Development, Kanazawa University, Kanazawa, Japan.'}, {'ForeName': 'Fumio', 'Initials': 'F', 'LastName': 'Ohtake', 'Affiliation': 'Department of Economics, Osaka University, Toyonaka, Osaka, Japan.'}]",Scientific reports,['10.1038/s41598-020-68445-w']
1292,32665410,Education Research: Online Alzheimer education for high school and college students: A randomized controlled trial.,"OBJECTIVE


Alzheimer disease (AD) risk factors are present throughout the lifespan. This randomized controlled trial evaluated the effectiveness of various online education strategies concerning AD risk reduction and brain health in younger populations.
METHOD


High school and college students were recruited via social media (Facebook and Instagram) to join AlzU.org, an evidence-based education portal, and were randomized to 1 of 4 courses: highly interactive webinar lessons narrated by actor Seth Rogen (celebrity webinar) or a physician (doctor webinar), minimally interactive video lessons with Seth Rogen (celebrity video), or minimally interactive video lessons (control). Surveys were administered at baseline and postcourse. The primary outcome was change in knowledge of AD risk reduction assessed by pre vs post lesson quiz scores. Secondary outcomes included change in awareness of AD research, hopefulness about AD, interest in pursuing health care, willingness to volunteer, and likelihood of recommending AlzU.org.
RESULT


A total of 721 participants joined. A total of 281 (38.9%) completed the course. Among college students, quiz score improvements were greater in celebrity webinar and celebrity video vs doctor webinar and control. Among high school students, no differences were found in quiz scores. In both groups, celebrity webinar, celebrity video, and doctor webinar resulted in greater improvements in awareness that nutrition and exercise may reduce AD risk vs controls. Among college students, celebrity webinar and celebrity video group participants felt more hopeful about the future of AD and more likely to recommend AlzU.org vs doctor webinar and control participants. Among college students, celebrity webinar, celebrity video, and doctor webinar participants were more willing to volunteer for AD causes and pursue health care careers vs controls.
CONCLUSION


Online education involving a celebrity may be an effective strategy for educating college students about AD risk reduction strategies. Further studies are warranted in high school students.",2020,"Among college students, quiz score improvements were greater in celebrity webinar and celebrity video vs doctor webinar and control.","['721 participants joined', 'high school and college students', 'college students, celebrity webinar, celebrity video, and doctor webinar participants', 'younger populations', 'High school and college students were recruited via social media (Facebook and Instagram) to join AlzU.org, an evidence-based education portal']","['various online education strategies concerning AD risk reduction', 'interactive webinar lessons narrated by actor Seth Rogen (celebrity webinar) or a physician (doctor webinar), minimally interactive video lessons with Seth Rogen (celebrity video), or minimally interactive video lessons (control']","['knowledge of AD risk reduction assessed by pre vs post lesson quiz scores', 'quiz score improvements', 'quiz scores', 'celebrity webinar and celebrity video vs doctor webinar and control', 'change in awareness of AD research, hopefulness about AD, interest in pursuing health care, willingness to volunteer, and likelihood of recommending AlzU.org']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0015621', 'cui_str': 'Famous Persons'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0205054', 'cui_str': 'Portal'}]","[{'cui': 'C4505477', 'cui_str': 'Online Education'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0335083', 'cui_str': 'Actor'}, {'cui': 'C0015621', 'cui_str': 'Famous Persons'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015621', 'cui_str': 'Famous Persons'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0392347', 'cui_str': 'Hope'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0033204', 'cui_str': 'Probability'}]",721.0,0.102402,"Among college students, quiz score improvements were greater in celebrity webinar and celebrity video vs doctor webinar and control.","[{'ForeName': 'Nabeel', 'Initials': 'N', 'LastName': 'Saif', 'Affiliation': 'From the Department of Neurology (N.S., K.N., M.D., G.S., H.H., M.M., R.S.I.), Weill Cornell Medicine & New York-Presbyterian, New York; Pacific Brain Health Center (J.F.H.), Pacific Neuroscience Institute, Los Angeles, CA; Harvard Medical School (M.W.), Boston, MA; Mailman School of Public Health (Y.A.), Columbia University, New York, NY; School of Law (O.S.) and College of Letters and Science (P.L.), University of California Los Angeles; Loyola School of Medicine (E.C.), Chicago, IL; and Biostatistics (N.K.), Pentara Corporation, Salt Lake City, UT.'}, {'ForeName': 'Kellyann', 'Initials': 'K', 'LastName': 'Niotis', 'Affiliation': 'From the Department of Neurology (N.S., K.N., M.D., G.S., H.H., M.M., R.S.I.), Weill Cornell Medicine & New York-Presbyterian, New York; Pacific Brain Health Center (J.F.H.), Pacific Neuroscience Institute, Los Angeles, CA; Harvard Medical School (M.W.), Boston, MA; Mailman School of Public Health (Y.A.), Columbia University, New York, NY; School of Law (O.S.) and College of Letters and Science (P.L.), University of California Los Angeles; Loyola School of Medicine (E.C.), Chicago, IL; and Biostatistics (N.K.), Pentara Corporation, Salt Lake City, UT.'}, {'ForeName': 'Moises', 'Initials': 'M', 'LastName': 'Dominguez', 'Affiliation': 'From the Department of Neurology (N.S., K.N., M.D., G.S., H.H., M.M., R.S.I.), Weill Cornell Medicine & New York-Presbyterian, New York; Pacific Brain Health Center (J.F.H.), Pacific Neuroscience Institute, Los Angeles, CA; Harvard Medical School (M.W.), Boston, MA; Mailman School of Public Health (Y.A.), Columbia University, New York, NY; School of Law (O.S.) and College of Letters and Science (P.L.), University of California Los Angeles; Loyola School of Medicine (E.C.), Chicago, IL; and Biostatistics (N.K.), Pentara Corporation, Salt Lake City, UT.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Hodes', 'Affiliation': 'From the Department of Neurology (N.S., K.N., M.D., G.S., H.H., M.M., R.S.I.), Weill Cornell Medicine & New York-Presbyterian, New York; Pacific Brain Health Center (J.F.H.), Pacific Neuroscience Institute, Los Angeles, CA; Harvard Medical School (M.W.), Boston, MA; Mailman School of Public Health (Y.A.), Columbia University, New York, NY; School of Law (O.S.) and College of Letters and Science (P.L.), University of California Los Angeles; Loyola School of Medicine (E.C.), Chicago, IL; and Biostatistics (N.K.), Pentara Corporation, Salt Lake City, UT.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Woodbury', 'Affiliation': 'From the Department of Neurology (N.S., K.N., M.D., G.S., H.H., M.M., R.S.I.), Weill Cornell Medicine & New York-Presbyterian, New York; Pacific Brain Health Center (J.F.H.), Pacific Neuroscience Institute, Los Angeles, CA; Harvard Medical School (M.W.), Boston, MA; Mailman School of Public Health (Y.A.), Columbia University, New York, NY; School of Law (O.S.) and College of Letters and Science (P.L.), University of California Los Angeles; Loyola School of Medicine (E.C.), Chicago, IL; and Biostatistics (N.K.), Pentara Corporation, Salt Lake City, UT.'}, {'ForeName': 'Yasmin', 'Initials': 'Y', 'LastName': 'Amini', 'Affiliation': 'From the Department of Neurology (N.S., K.N., M.D., G.S., H.H., M.M., R.S.I.), Weill Cornell Medicine & New York-Presbyterian, New York; Pacific Brain Health Center (J.F.H.), Pacific Neuroscience Institute, Los Angeles, CA; Harvard Medical School (M.W.), Boston, MA; Mailman School of Public Health (Y.A.), Columbia University, New York, NY; School of Law (O.S.) and College of Letters and Science (P.L.), University of California Los Angeles; Loyola School of Medicine (E.C.), Chicago, IL; and Biostatistics (N.K.), Pentara Corporation, Salt Lake City, UT.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Sadek', 'Affiliation': 'From the Department of Neurology (N.S., K.N., M.D., G.S., H.H., M.M., R.S.I.), Weill Cornell Medicine & New York-Presbyterian, New York; Pacific Brain Health Center (J.F.H.), Pacific Neuroscience Institute, Los Angeles, CA; Harvard Medical School (M.W.), Boston, MA; Mailman School of Public Health (Y.A.), Columbia University, New York, NY; School of Law (O.S.) and College of Letters and Science (P.L.), University of California Los Angeles; Loyola School of Medicine (E.C.), Chicago, IL; and Biostatistics (N.K.), Pentara Corporation, Salt Lake City, UT.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Scheyer', 'Affiliation': 'From the Department of Neurology (N.S., K.N., M.D., G.S., H.H., M.M., R.S.I.), Weill Cornell Medicine & New York-Presbyterian, New York; Pacific Brain Health Center (J.F.H.), Pacific Neuroscience Institute, Los Angeles, CA; Harvard Medical School (M.W.), Boston, MA; Mailman School of Public Health (Y.A.), Columbia University, New York, NY; School of Law (O.S.) and College of Letters and Science (P.L.), University of California Los Angeles; Loyola School of Medicine (E.C.), Chicago, IL; and Biostatistics (N.K.), Pentara Corporation, Salt Lake City, UT.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Caesar', 'Affiliation': 'From the Department of Neurology (N.S., K.N., M.D., G.S., H.H., M.M., R.S.I.), Weill Cornell Medicine & New York-Presbyterian, New York; Pacific Brain Health Center (J.F.H.), Pacific Neuroscience Institute, Los Angeles, CA; Harvard Medical School (M.W.), Boston, MA; Mailman School of Public Health (Y.A.), Columbia University, New York, NY; School of Law (O.S.) and College of Letters and Science (P.L.), University of California Los Angeles; Loyola School of Medicine (E.C.), Chicago, IL; and Biostatistics (N.K.), Pentara Corporation, Salt Lake City, UT.'}, {'ForeName': 'Hollie', 'Initials': 'H', 'LastName': 'Hristov', 'Affiliation': 'From the Department of Neurology (N.S., K.N., M.D., G.S., H.H., M.M., R.S.I.), Weill Cornell Medicine & New York-Presbyterian, New York; Pacific Brain Health Center (J.F.H.), Pacific Neuroscience Institute, Los Angeles, CA; Harvard Medical School (M.W.), Boston, MA; Mailman School of Public Health (Y.A.), Columbia University, New York, NY; School of Law (O.S.) and College of Letters and Science (P.L.), University of California Los Angeles; Loyola School of Medicine (E.C.), Chicago, IL; and Biostatistics (N.K.), Pentara Corporation, Salt Lake City, UT.'}, {'ForeName': 'Newman', 'Initials': 'N', 'LastName': 'Knowlton', 'Affiliation': 'From the Department of Neurology (N.S., K.N., M.D., G.S., H.H., M.M., R.S.I.), Weill Cornell Medicine & New York-Presbyterian, New York; Pacific Brain Health Center (J.F.H.), Pacific Neuroscience Institute, Los Angeles, CA; Harvard Medical School (M.W.), Boston, MA; Mailman School of Public Health (Y.A.), Columbia University, New York, NY; School of Law (O.S.) and College of Letters and Science (P.L.), University of California Los Angeles; Loyola School of Medicine (E.C.), Chicago, IL; and Biostatistics (N.K.), Pentara Corporation, Salt Lake City, UT.'}, {'ForeName': 'Paige', 'Initials': 'P', 'LastName': 'Lee', 'Affiliation': 'From the Department of Neurology (N.S., K.N., M.D., G.S., H.H., M.M., R.S.I.), Weill Cornell Medicine & New York-Presbyterian, New York; Pacific Brain Health Center (J.F.H.), Pacific Neuroscience Institute, Los Angeles, CA; Harvard Medical School (M.W.), Boston, MA; Mailman School of Public Health (Y.A.), Columbia University, New York, NY; School of Law (O.S.) and College of Letters and Science (P.L.), University of California Los Angeles; Loyola School of Medicine (E.C.), Chicago, IL; and Biostatistics (N.K.), Pentara Corporation, Salt Lake City, UT.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'McInnis', 'Affiliation': 'From the Department of Neurology (N.S., K.N., M.D., G.S., H.H., M.M., R.S.I.), Weill Cornell Medicine & New York-Presbyterian, New York; Pacific Brain Health Center (J.F.H.), Pacific Neuroscience Institute, Los Angeles, CA; Harvard Medical School (M.W.), Boston, MA; Mailman School of Public Health (Y.A.), Columbia University, New York, NY; School of Law (O.S.) and College of Letters and Science (P.L.), University of California Los Angeles; Loyola School of Medicine (E.C.), Chicago, IL; and Biostatistics (N.K.), Pentara Corporation, Salt Lake City, UT.'}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Isaacson', 'Affiliation': 'From the Department of Neurology (N.S., K.N., M.D., G.S., H.H., M.M., R.S.I.), Weill Cornell Medicine & New York-Presbyterian, New York; Pacific Brain Health Center (J.F.H.), Pacific Neuroscience Institute, Los Angeles, CA; Harvard Medical School (M.W.), Boston, MA; Mailman School of Public Health (Y.A.), Columbia University, New York, NY; School of Law (O.S.) and College of Letters and Science (P.L.), University of California Los Angeles; Loyola School of Medicine (E.C.), Chicago, IL; and Biostatistics (N.K.), Pentara Corporation, Salt Lake City, UT. rii9004@med.cornell.edu.'}]",Neurology,['10.1212/WNL.0000000000009859']
1293,32666402,Associations between commonly used patient-reported outcome tools in postpartum depression clinical practice and the Hamilton Rating Scale for Depression.,"The objective of this study is to explore the associations between the patient-reported Edinburgh Postnatal Depression Scale (EPDS) and Patient Health Questionnaire (PHQ)-9 and clinician-reported 17-item Hamilton Depression Rating Scale (HAMD-17) in order to facilitate clinical decision-making. An integrated efficacy dataset of three randomized placebo-controlled trials (NCT02614547, NCT02942004, and NCT02942017) evaluating brexanolone injection, a neuroactive steroid chemically identical to allopregnanolone, in women with postpartum depression was used for this post hoc analysis. Data were pooled across treatment arms. Associations were assessed at day 30 (end-of-trial follow-up). Pearson correlation assessed the relationship between EPDS and PHQ-9 item and total scores and HAMD-17 total score. Cohen's kappa assessed agreement of EPDS remission (score < 10) and PHQ-9 remission (score < 5) with HAMD-17 remission (score ≤ 7). Ordinary least squares (OLS) regression models were used to develop equations estimating HAMD-17 total scores from EPDS and PHQ-9 scores, respectively. The total scores showed large correlations (HAMD-17/EPDS: r = 0.71, p < 0.001; HAMD-17/PHQ-9: r = 0.75, p < 0.001). Individual EPDS and PHQ-9 items significantly correlated (r= 0.35 to 0.67, all p < 0.001) with HAMD-17 total score. EPDS had 79% sensitivity and 67% specificity to detect HAMD-17 remission; corresponding estimates for PHQ-9 were 76% and 78%. OLS models yielded the following equations: HAMD-17 total = 2.66 + (EPDS total × 0.87) and HAMD-17 total = 3.99 + (PHQ-9 total × 0.97). There were large and statistically significant associations between patient-reported outcomes (EPDS, PHQ-9) and clinician-reported outcomes (HAMD-17) as clinical improvements were associated with patient-reported symptom improvement. These results provide tools to help translate clinical trial data to clinical practice, thus aiding shared decision-making for this critical population.",2020,EPDS had 79% sensitivity and 67% specificity to detect HAMD-17 remission; corresponding estimates for PHQ-9 were 76% and 78%.,['women with postpartum depression'],"['brexanolone injection', 'placebo']","['PHQ-9 remission', 'Edinburgh Postnatal Depression Scale (EPDS) and Patient Health Questionnaire (PHQ)-9 and clinician-reported 17-item Hamilton Depression Rating Scale (HAMD-17', 'EPDS and PHQ-9 item and total scores and HAMD-17 total score', 'EPDS remission', 'Hamilton Rating Scale for Depression', 'Individual EPDS and PHQ-9 items']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0221074', 'cui_str': 'Postpartum depression'}]","[{'cui': 'C4765158', 'cui_str': 'brexanolone Injection'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0451144', 'cui_str': 'Edinburgh postnatal depression scale'}, {'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",,0.0698929,EPDS had 79% sensitivity and 67% specificity to detect HAMD-17 remission; corresponding estimates for PHQ-9 were 76% and 78%.,"[{'ForeName': 'Margaret E', 'Initials': 'ME', 'LastName': 'Gerbasi', 'Affiliation': 'Sage Therapeutics, Inc., Cambridge, MA, USA.'}, {'ForeName': 'Adi', 'Initials': 'A', 'LastName': 'Eldar-Lissai', 'Affiliation': 'Sage Therapeutics, Inc., Cambridge, MA, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Acaster', 'Affiliation': 'Acaster Lloyd Consulting Ltd., London, UK.'}, {'ForeName': 'Moshe', 'Initials': 'M', 'LastName': 'Fridman', 'Affiliation': 'AMF Consulting, Los Angeles, CA, USA.'}, {'ForeName': 'Vijayveer', 'Initials': 'V', 'LastName': 'Bonthapally', 'Affiliation': 'Sage Therapeutics, Inc., Cambridge, MA, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Hodgkins', 'Affiliation': 'Sage Therapeutics, Inc., Cambridge, MA, USA.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Kanes', 'Affiliation': 'Sage Therapeutics, Inc., Cambridge, MA, USA.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Meltzer-Brody', 'Affiliation': 'Department of Psychiatry, University of North Carolina School of Medicine, 101 Manning Drive, Chapel Hill, NC, 27514, USA. samantha_meltzer-brody@med.unc.edu.'}]",Archives of women's mental health,['10.1007/s00737-020-01042-y']
1294,32669656,"Pharmacokinetics and safety of IBI301 versus rituximab in patients with CD20 +  B-cell lymphoma: a multicenter, randomized, double-blind, parallel-controlled study.","This multicenter, randomized, double-blind, parallel-controlled trial aimed to compare the pharmacokinetics (PK) of IBI301 with rituximab in patients with CD20-positive (CD20 + ) B-cell lymphoma, who achieved a complete response/unconfirmed complete response after standard treatments. Patients were randomized (1:1) to receive IBI301 or rituximab (375 mg/m 2 , IV). Patients who continuously benefitted from the trial after the PK phase underwent the extension phase to receive up to three cycles of 3-month-cycle of rituximab/IBI301 maintenance therapy. PK was described using the area under the serum concentration-time curve from time zero to infinity (AUC 0-inf ), AUC from time zero to last quantifiable concentration (AUC 0-t ), and maximum serum concentration (C max ). Pharmacodynamics (PD), incidence of adverse events and immunogenicity were evaluated. PK was defined equivalent, if 90% confidence intervals (CIs) for geometric mean ratios of PK endpoints fell within the margin of 0.8-1.25. Overall, 181 patients were enrolled in IBI301 (n = 89) and rituximab (n = 92) groups. Geometric mean ratios of AUC 0-inf , AUC 0-t , and C max  were 0.91 (90% CI 0.85, 0.97), 0.91 (90% CI 0.86, 0.97), and 0.96 (90% CI 0.92, 1.01) between treatment groups, all within the bioequivalence range. Peripheral CD19 +  and CD20 +  B-cell counts were similar at each prespecified time point between the groups. No difference in immunogenicity was observed. The incidences of treatment-emergent adverse events (84.3% vs. 83.5%) and treatment-related AEs (56.2% vs. 61.5%) were comparable (IBI301 vs. rituximab). IBI301 was PK bioequivalent to rituximab in patients with CD20 +  B-cell lymphoma. The PD, safety, and immunogenicity profiles of IBI301 were similar to those of rituximab.",2020,The incidences of treatment-emergent adverse events (84.3% vs. 83.5%) and treatment-related AEs (56.2% vs. 61.5%) were comparable (IBI301 vs. rituximab).,"['patients with CD20 +  B-cell lymphoma', 'patients with CD20-positive (CD20 + ) B-cell lymphoma', '181 patients were enrolled in IBI301 (n\u2009=\u200989) and rituximab (n\u2009=\u200992) groups']","['rituximab/IBI301 maintenance therapy', 'IBI301 with rituximab', 'IBI301 or rituximab', 'IBI301 versus rituximab', 'rituximab']","['immunogenicity', 'incidences of treatment-emergent adverse events', 'PD, safety, and immunogenicity profiles of IBI301', 'Geometric mean ratios of AUC 0-inf , AUC 0-t , and C max', 'Peripheral CD19 +  and CD20 +  B-cell counts', 'Pharmacodynamics (PD), incidence of adverse events and immunogenicity', 'maximum serum concentration (C max ']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3888518', 'cui_str': 'CD20 antigen positive'}, {'cui': 'C0079731', 'cui_str': 'B-cell lymphoma (clinical)'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0108748', 'cui_str': 'Lymphocyte antigen CD19'}, {'cui': 'C3888518', 'cui_str': 'CD20 antigen positive'}, {'cui': 'C0004561', 'cui_str': 'B lymphocyte'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",181.0,0.268598,The incidences of treatment-emergent adverse events (84.3% vs. 83.5%) and treatment-related AEs (56.2% vs. 61.5%) were comparable (IBI301 vs. rituximab).,"[{'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Jiang', 'Affiliation': 'State Key Laboratory of Experimental Hematology, National Clinical Research Center for Hematological Disorders, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Tianjin, China.'}, {'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Ke', 'Affiliation': 'Hematology Department, Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Qingyuan', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Oncology Department, The Affiliated Cancer Hospital of Harbin Medical University, Harbin, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Xu', 'Affiliation': 'Hematology Department, Jiangsu Province Hospital, Nanjing, China.'}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Su', 'Affiliation': 'Department of Lymphoma/Head and Neck Oncology, The Fifth Medical Center of PLA General Hospital, Beijing, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Hematology Department, West China Hospital Sichuan University, Chengdu, China.'}, {'ForeName': 'Mingzhi', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Oncology Department, The First Affiliated Hospital of Zhengzhou Medical University, Zhengzhou, China.'}, {'ForeName': 'Huaqing', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Oncology Department, Tianjin Union Medical Center Nankai University Affiliated Hospital, Tianjin, China.'}, {'ForeName': 'Chuan', 'Initials': 'C', 'LastName': 'Jin', 'Affiliation': 'Forth Medical Department, The Affiliated Cancer Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Lymphoma, Peking University Cancer Hospital and Institute, Beijing, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': ""Hematology Department, Tangdu Hospital, The Medical University of Air Forces, Xi'an, China.""}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Cai', 'Affiliation': 'Bone Marrow Transplantation Center, The First Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Xielan', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Hematology Department, Xiangya Hospital Central South University, Changsha, China.'}, {'ForeName': 'Jianfeng', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Hematology Department, Tongji Medical College Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Xiaohong', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Hematology Department, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Hematology Department, The Third Xiangya Hospital of Central South University, Changsha, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': 'Innovent Biologics, Inc., Suzhou, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'Innovent Biologics, Inc., Suzhou, China.'}, {'ForeName': 'Xing', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'Innovent Biologics, Inc., Suzhou, China.'}, {'ForeName': 'Junyuan', 'Initials': 'J', 'LastName': 'Qi', 'Affiliation': 'State Key Laboratory of Experimental Hematology, National Clinical Research Center for Hematological Disorders, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Tianjin, China.'}, {'ForeName': 'Lugui', 'Initials': 'L', 'LastName': 'Qiu', 'Affiliation': 'State Key Laboratory of Experimental Hematology, National Clinical Research Center for Hematological Disorders, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Tianjin, China. qiulg@ihcams.ac.cn.'}]",Scientific reports,['10.1038/s41598-020-68360-0']
1295,32669672,"The ProtecT randomised trial cost-effectiveness analysis comparing active monitoring, surgery, or radiotherapy for prostate cancer.","BACKGROUND


There is limited evidence relating to the cost-effectiveness of treatments for localised prostate cancer.
METHODS


The cost-effectiveness of active monitoring, surgery, and radiotherapy was evaluated within the Prostate Testing for Cancer and Treatment (ProtecT) randomised controlled trial from a UK NHS perspective at 10 years' median follow-up. Prostate cancer resource-use collected from hospital records and trial participants was valued using UK reference-costs. QALYs (quality-adjusted-life-years) were calculated from patient-reported EQ-5D-3L measurements. Adjusted mean costs, QALYs, and incremental cost-effectiveness ratios were calculated; cost-effectiveness acceptability curves and sensitivity analyses addressed uncertainty; subgroup analyses considered age and disease-risk.
RESULTS


Adjusted mean QALYs were similar between groups: 6.89 (active monitoring), 7.09 (radiotherapy), and 6.91 (surgery). Active monitoring had lower adjusted mean costs (£5913) than radiotherapy (£7361) and surgery (£7519). Radiotherapy was the most likely (58% probability) cost-effective option at the UK NICE willingness-to-pay threshold (£20,000 per QALY). Subgroup analyses confirmed radiotherapy was cost-effective for older men and intermediate/high-risk disease groups; active monitoring was more likely to be the cost-effective option for younger men and low-risk groups.
CONCLUSIONS


Longer follow-up and modelling are required to determine the most cost-effective treatment for localised prostate cancer over a man's lifetime.
TRIAL REGISTRATION


Current Controlled Trials number, ISRCTN20141297: http://isrctn.org (14/10/2002); ClinicalTrials.gov number, NCT02044172: http://www.clinicaltrials.gov (23/01/2014).",2020,"Adjusted mean QALYs were similar between groups: 6.89 (active monitoring), 7.09 (radiotherapy), and 6.91 (surgery).",['prostate cancer'],"['active monitoring, surgery, or radiotherapy', 'active monitoring, surgery, and radiotherapy', 'radiotherapy', 'Radiotherapy']","['Adjusted mean costs, QALYs, and incremental cost-effectiveness ratios']","[{'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}]","[{'cui': 'C1531698', 'cui_str': 'Active monitoring'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",,0.173558,"Adjusted mean QALYs were similar between groups: 6.89 (active monitoring), 7.09 (radiotherapy), and 6.91 (surgery).","[{'ForeName': 'Sian M', 'Initials': 'SM', 'LastName': 'Noble', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK. s.m.noble@bristol.ac.uk.'}, {'ForeName': 'Kirsty', 'Initials': 'K', 'LastName': 'Garfield', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'J Athene', 'Initials': 'JA', 'LastName': 'Lane', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Metcalfe', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Davis', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Eleanor I', 'Initials': 'EI', 'LastName': 'Walsh', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Martin', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Emma L', 'Initials': 'EL', 'LastName': 'Turner', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Tim J', 'Initials': 'TJ', 'LastName': 'Peters', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Joanna C', 'Initials': 'JC', 'LastName': 'Thorn', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Malcolm', 'Initials': 'M', 'LastName': 'Mason', 'Affiliation': 'The School of Medicine, University of Cardiff, Cardiff, UK.'}, {'ForeName': 'Prasad', 'Initials': 'P', 'LastName': 'Bollina', 'Affiliation': 'Department of Urology and Surgery, Western General Hospital, Edinburgh, UK.'}, {'ForeName': 'James W F', 'Initials': 'JWF', 'LastName': 'Catto', 'Affiliation': 'The Academic Urology Unit, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Doherty', 'Affiliation': 'Department of Urology, Queen Elizabeth Hospital, Birmingham, UK.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Gnanapragasam', 'Affiliation': 'The Academic Urology Group, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Owen', 'Initials': 'O', 'LastName': 'Hughes', 'Affiliation': 'Department of Urology, Cardiff and Vale University Health Board, Cardiff, UK.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Kockelbergh', 'Affiliation': 'Department of Urology, University Hospitals Leicester, Leicester, UK.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Kynaston', 'Affiliation': 'The School of Medicine, University of Cardiff, Cardiff, UK.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Paul', 'Affiliation': 'Department of Urology, Leeds Teaching Hospitals NHS Trust, Leeds, UK.'}, {'ForeName': 'Edgar', 'Initials': 'E', 'LastName': 'Paez', 'Affiliation': 'Department of Urology, Freeman Hospital, Newcastle-upon-Tyne, UK.'}, {'ForeName': 'Derek J', 'Initials': 'DJ', 'LastName': 'Rosario', 'Affiliation': 'Department of Urology, Sheffield Teaching Hospitals, Sheffield, UK.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Rowe', 'Affiliation': 'Bristol Urological Institute, North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Oxley', 'Affiliation': 'Department of Cellular Pathology, North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Staffurth', 'Affiliation': 'The School of Medicine, University of Cardiff, Cardiff, UK.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Neal', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Freddie C', 'Initials': 'FC', 'LastName': 'Hamdy', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Jenny L', 'Initials': 'JL', 'LastName': 'Donovan', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}]",British journal of cancer,['10.1038/s41416-020-0978-4']
1296,32656664,"Effects of caffeine intake on the biomechanical properties of the cornea: a placebo-controlled, double-blind, crossover pilot study in low caffeine consumers.","PURPOSE


To assess the short-term effects of caffeine intake on the biomechanical properties of the cornea, as well as its possible association with the intraocular pressure (IOP), as measured by corneal visualization Scheimpflug technology (CorVis ST) in healthy subjects.
METHODS


Twenty-two low caffeine consumers ingested either a caffeine (4 mg/Kg) or placebo capsule in two separate sessions. IOP and corneal biomechanics parameters, including time, velocity, length, and deformation amplitude at the first applanation (A1T, A1V, A1L, and A1D, respectively); time, velocity, length, and deformation amplitude at the second applanation (A2T, A2V, A2L, and A2D, respectively); time at the highest concavity (HCT), radius curvature at the highest concavity (HCR), deformation amplitude at the highest concavity (HCDA), and peak distance (PD), were measured with the Corvis ST before and after 30 min, 60 min, and 90 min of caffeine/placebo intake.
RESULTS


Caffeine intake reduced the corneal deformability, inducing significant changes in A1T, A2V, A2T, HCDA, HCT, and PD (all p values < 0.05). Non-corrected and biomechanically corrected IOP values were higher after caffeine intake (p = 0.001 and 0.033, respectively). Also, the changes in IOP after caffeine intake were positively associated with A1T (r = 0.790 to 0.962), and negatively associated with A2T (r = - 0.230 to - 0.722) and PD (r = - 0.506 to - 0.644).
CONCLUSIONS


Caffeine intake reduces the corneal deformability, with these changes being partially associated with the IOP rise. These findings evidence that exogenous factors such as caffeine intake should be taken into consideration when making clinical decisions that are based on the biomechanical properties of the cornea.",2020,"Non-corrected and biomechanically corrected IOP values were higher after caffeine intake (p = 0.001 and 0.033, respectively).","['healthy subjects', 'low caffeine consumers', 'Twenty-two low caffeine consumers ingested either a']","['caffeine intake', 'caffeine', 'caffeine/placebo', 'caffeine (4\xa0mg/Kg) or placebo capsule', 'placebo']","['biomechanical properties of the cornea', 'IOP values', 'changes in IOP', 'IOP and corneal biomechanics parameters, including time, velocity, length, and deformation amplitude at the first applanation (A1T, A1V, A1L, and A1D, respectively); time, velocity, length, and deformation amplitude at the second applanation (A2T, A2V, A2L, and A2D, respectively); time at the highest concavity (HCT), radius curvature at the highest concavity (HCR), deformation amplitude at the highest concavity (HCDA), and peak distance (PD', 'A1T, A2V, A2T, HCDA, HCT, and PD', 'intraocular pressure (IOP', 'corneal deformability']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}]","[{'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}]","[{'cui': 'C0871161', 'cui_str': 'Property'}, {'cui': 'C0010031', 'cui_str': 'Corneal structure'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0034627', 'cui_str': 'Bone structure of radius'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0625485', 'cui_str': '5,9-hexacosadienoic acid'}]",22.0,0.0561261,"Non-corrected and biomechanically corrected IOP values were higher after caffeine intake (p = 0.001 and 0.033, respectively).","[{'ForeName': 'Raimundo', 'Initials': 'R', 'LastName': 'Jiménez', 'Affiliation': 'Department of Optics, University of Granada, Campus de la Fuentenueva 2, 18071, Granada, Spain.'}, {'ForeName': 'Rubén', 'Initials': 'R', 'LastName': 'Molina', 'Affiliation': 'Department of Optics, University of Granada, Campus de la Fuentenueva 2, 18071, Granada, Spain.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Redondo', 'Affiliation': 'Department of Optics, University of Granada, Campus de la Fuentenueva 2, 18071, Granada, Spain. beatrizrc@ugr.es.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Vera', 'Affiliation': 'Department of Optics, University of Granada, Campus de la Fuentenueva 2, 18071, Granada, Spain.'}]",Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie,['10.1007/s00417-020-04835-0']
1297,32660264,"Resistance Training Impact on Mobility, Muscle Strength and Lean Mass in Pancreatic Cancer Cachexia: A Randomized Controlled Trial.","OBJECTIVE


To determine the efficacy of a three-month resistance training programme on the mobility, muscle strength and lean body mass of patients with pancreatic cancer-induced cachexia.
DESIGN


Randomized controlled trial.
SETTING


Elsahel Teaching Hospital, outpatient clinic of the Faculty of Physical Therapy, Cairo, Egypt.
PARTICIPANTS


Patients with pancreatic cancer-induced cachexia.
INTERVENTIONS


Participants were randomized to the resistance training group ( n  = 20) and control group ( n  = 20).
MAIN MEASURES


Outcomes including mobility, muscle strength and lean body mass were measured at baseline, three months after surgical resection and 12 weeks after intervention.
RESULTS


The mean (SD) age was 51.9 (5.03) years and body mass index was 21.1 (1.13) kg/m²; 65% of patients were male. Compared to the control group, the resistance training group showed significant improvement in mobility: 400-m walk performance (270.3-256.9 seconds vs 266.4-264.2 seconds, respectively) and chair rise (13.82-12.53 seconds vs 13.77-13.46 seconds, respectively). Similarly, muscle strength was also significantly improved in the resistance training group than in the control group; we observed increase in peak torque of knee extensors ( P  = 0.004), elbow flexors ( P  = 0.001) and elbow extensors, improvement in lean mass of the upper limb (6.28-6.46 kg vs 6.31-6.23 kg, respectively) and lower limb (16.31-16.58 kg vs 16.4-16.31 kg, respectively).
CONCLUSION


A three-month resistance training improved the mobility of patients with pancreatic cancer-induced cachexia. Muscle strength and lean body mass also improved.",2020,"Compared to the control group, the resistance training group showed significant improvement in mobility: 400-m walk performance (270.3-256.9 seconds vs 266.4-264.2 seconds, respectively) and chair rise (13.82-12.53 seconds vs 13.77-13.46 seconds, respectively).","['Patients with pancreatic cancer-induced cachexia', 'The mean (SD) age was 51.9 (5.03) years and body mass index was 21.1 (1.13)\u2009kg/m²; 65% of patients were male', 'Pancreatic Cancer Cachexia', 'patients with pancreatic cancer-induced cachexia', 'Elsahel Teaching Hospital, outpatient clinic of the Faculty of Physical Therapy, Cairo, Egypt']","['resistance training programme', 'resistance training group ( n \u2009=\u200920) and control group ( n \u2009=\u200920', 'Resistance Training', 'resistance training']","['lower limb', 'elbow flexors', 'mobility: 400-m walk performance', 'mobility, muscle strength and lean body mass', 'muscle strength', 'chair rise', 'Mobility, Muscle Strength and Lean Mass', 'peak torque of knee extensors', 'Muscle strength and lean body mass', 'elbow extensors, improvement in lean mass of the upper limb']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0235974', 'cui_str': 'Carcinoma of pancreas'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0006625', 'cui_str': 'Cachexia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0015535', 'cui_str': 'Faculty'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0013715', 'cui_str': 'Egypt'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}]",,0.0445473,"Compared to the control group, the resistance training group showed significant improvement in mobility: 400-m walk performance (270.3-256.9 seconds vs 266.4-264.2 seconds, respectively) and chair rise (13.82-12.53 seconds vs 13.77-13.46 seconds, respectively).","[{'ForeName': 'FatmaAlzahraa H', 'Initials': 'FH', 'LastName': 'Kamel', 'Affiliation': 'Department of Physical Therapy for Surgery, Faculty of Physical Therapy, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Maged A', 'Initials': 'MA', 'LastName': 'Basha', 'Affiliation': 'Department of Physical Therapy, College of Medical Rehabilitation, Qassim University, Buraidah, Qassim, Saudi Arabia.'}, {'ForeName': 'Ashwag S', 'Initials': 'AS', 'LastName': 'Alsharidah', 'Affiliation': 'Department of Physiology, College of Medicine, Qassim University, Buraidah, Qassim, Saudi Arabia.'}, {'ForeName': 'Amr B', 'Initials': 'AB', 'LastName': 'Salama', 'Affiliation': 'Department of Physical Therapy for Surgery, Faculty of Physical Therapy, Cairo University, Cairo, Egypt.'}]",Clinical rehabilitation,['10.1177/0269215520941912']
1298,32665656,The effect of epinephrine on the perfusion index during ultrasound-guided supraclavicular brachial plexus block: a randomized controlled trial.,"The perfusion index (PI) is an objective tool used to assess a successful nerve block. Epinephrine is a widely used adjuvant to local anesthetics, and it may affect PI values because of the vasoconstrictive property. The aim of this study was to investigate the influence of epinephrine on PI as an indicator of a successful block in ultrasound-guided supraclavicular brachial plexus block (SCBPB). In this randomized controlled trial, 82 adult patients underwent upper limb surgery under SCBPB were recruited between July 2018 and March 2019 in a single tertiary care center. Participants were randomly assigned to one of two groups: non-epinephrine group (n = 41) or epinephrine group (5 mcg ml -1 , n = 41). The primary outcome was the comparison of the ""PI ratio 10,"" which was defined as the ratio of the PI 10 to the baseline. Receiver operating characteristic (ROC) curves were constructed to determine the accuracy of the PI in predicting the block success at each time interval. The PI ratio 10 was 2.7 (1.9-4.0) in non-epinephrine group and 3.3 (2.2-4.4) in epinephrine group (median difference: 0.4; 95% confidence interval [CI] - 1.1 to 0.2; P = 0.207). The ROC curves compared without group identification were not significantly different over time. The cut-off value for the PI and PI ratio at 5 min (PI ratio 5) were 7.7 (area under the ROC [AUROC]: 0.89, 95% CI 0.83-0.94) and 1.6 (AUROC: 0.94, 95% CI 0.90-0.98), respectively. The perineural epinephrine did not affect the PI following a SCBPB. The PI ratio 5 > 1.6 might be considered as a relatively accurate predictor of a successful SCBPB.Trial registration: This study was registered at the Clinical Trial Registry of Korea (https://cris.nih.go.kr. CriS No. KCT0003006).",2020,The PI ratio 10 was 2.7 (1.9-4.0) in non-epinephrine group and 3.3 (2.2-4.4) in epinephrine group (median difference: 0.4; 95% confidence interval [CI] - 1.1 to 0.2; P = 0.207).,"['ultrasound-guided supraclavicular brachial plexus block', '82 adult patients underwent upper limb surgery under SCBPB were recruited between July 2018 and March 2019 in a single tertiary care center']","['CriS', 'Epinephrine', 'epinephrine']","['perfusion index', 'ROC curves', 'perfusion index (PI', 'comparison of the ""PI ratio 10,"" which was defined as the ratio of the PI 10 to the baseline', 'PI ratio 10', 'cut-off value for the PI and PI ratio']","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0394699', 'cui_str': 'Brachial plexus block by supraclavicular approach'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}]","[{'cui': 'C0014563', 'cui_str': 'Epinephrine'}]","[{'cui': 'C2964282', 'cui_str': 'Perfusion Index'}, {'cui': 'C0035787', 'cui_str': 'ROC Analysis'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0000925', 'cui_str': 'Incised wound'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",82.0,0.235258,The PI ratio 10 was 2.7 (1.9-4.0) in non-epinephrine group and 3.3 (2.2-4.4) in epinephrine group (median difference: 0.4; 95% confidence interval [CI] - 1.1 to 0.2; P = 0.207).,"[{'ForeName': 'Doyeon', 'Initials': 'D', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul, 06351, Republic of Korea.'}, {'ForeName': 'Ji Seon', 'Initials': 'JS', 'LastName': 'Jeong', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul, 06351, Republic of Korea.'}, {'ForeName': 'Min Jong', 'Initials': 'MJ', 'LastName': 'Park', 'Affiliation': 'Department of Orthopedic Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Justin Sangwook', 'Initials': 'JS', 'LastName': 'Ko', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul, 06351, Republic of Korea. jsko@skku.edu.'}]",Scientific reports,['10.1038/s41598-020-68475-4']
1299,32668111,Ticagrelor and Aspirin or Aspirin Alone in Acute Ischemic Stroke or TIA.,"BACKGROUND


Trials have evaluated the use of clopidogrel and aspirin to prevent stroke after an ischemic stroke or transient ischemic attack (TIA). In a previous trial, ticagrelor was not better than aspirin in preventing vascular events or death after stroke or TIA. The effect of the combination of ticagrelor and aspirin on prevention of stroke has not been well studied.
METHODS


We conducted a randomized, placebo-controlled, double-blind trial involving patients who had had a mild-to-moderate acute noncardioembolic ischemic stroke, with a National Institutes of Health Stroke Scale (NIHSS) score of 5 or less (range, 0 to 42, with higher scores indicating more severe stroke), or TIA and who were not undergoing thrombolysis or thrombectomy. The patients were assigned within 24 hours after symptom onset, in a 1:1 ratio, to receive a 30-day regimen of either ticagrelor (180-mg loading dose followed by 90 mg twice daily) plus aspirin (300 to 325 mg on the first day followed by 75 to 100 mg daily) or matching placebo plus aspirin. The primary outcome was a composite of stroke or death within 30 days. Secondary outcomes were first subsequent ischemic stroke and the incidence of disability within 30 days. The primary safety outcome was severe bleeding.
RESULTS


A total of 11,016 patients underwent randomization (5523 in the ticagrelor-aspirin group and 5493 in the aspirin group). A primary-outcome event occurred in 303 patients (5.5%) in the ticagrelor-aspirin group and in 362 patients (6.6%) in the aspirin group (hazard ratio, 0.83; 95% confidence interval [CI], 0.71 to 0.96; P = 0.02). Ischemic stroke occurred in 276 patients (5.0%) in the ticagrelor-aspirin group and in 345 patients (6.3%) in the aspirin group (hazard ratio, 0.79; 95% CI, 0.68 to 0.93; P = 0.004). The incidence of disability did not differ significantly between the two groups. Severe bleeding occurred in 28 patients (0.5%) in the ticagrelor-aspirin group and in 7 patients (0.1%) in the aspirin group (P = 0.001).
CONCLUSIONS


Among patients with a mild-to-moderate acute noncardioembolic ischemic stroke (NIHSS score ≤5) or TIA who were not undergoing intravenous or endovascular thrombolysis, the risk of the composite of stroke or death within 30 days was lower with ticagrelor-aspirin than with aspirin alone, but the incidence of disability did not differ significantly between the two groups. Severe bleeding was more frequent with ticagrelor. (Funded by AstraZeneca; THALES ClinicalTrial.gov number, NCT03354429.).",2020,The incidence of disability did not differ significantly between the two groups.,"['patients who had had a mild-to-moderate acute noncardioembolic ischemic stroke, with a National Institutes of Health Stroke Scale (NIHSS) score of 5 or less (range, 0 to 42, with higher scores indicating more severe stroke), or TIA and who were not undergoing thrombolysis or thrombectomy', 'group and 5493 in the aspirin group', '11,016 patients underwent randomization (5523 in the', 'Acute Ischemic Stroke or TIA', 'patients with a mild-to-moderate acute noncardioembolic ischemic stroke (NIHSS score ≤5) or TIA who were not undergoing intravenous or']","['placebo', 'ticagrelor-aspirin', 'endovascular thrombolysis', 'Ticagrelor and Aspirin or Aspirin Alone', 'aspirin', 'placebo plus aspirin', 'clopidogrel and aspirin', 'ticagrelor and aspirin', 'ticagrelor']","['incidence of disability', 'severe bleeding', 'Severe bleeding', 'risk of the composite of stroke or death', 'subsequent ischemic stroke and the incidence of disability', 'composite of stroke or death within 30 days', 'Ischemic stroke']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C3472496', 'cui_str': 'National Institutes of Health stroke scale'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0162578', 'cui_str': 'Removal of thrombus'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",11016.0,0.444595,The incidence of disability did not differ significantly between the two groups.,"[{'ForeName': 'S Claiborne', 'Initials': 'SC', 'LastName': 'Johnston', 'Affiliation': ""From the Dean's Office, Dell Medical School, University of Texas at Austin, Austin (S.C.J.); the Department of Neurology and Stroke Center, Bichat-Claude Bernard Hospital, University of Paris, Paris (P.A.); Biopharmaceuticals Research and Development, AstraZeneca, Gothenburg (H.D., A.H., M.K., P.L.), and the Department of Medical Sciences, Uppsala University, Uppsala (S.J.) - both in Sweden; the Biostatistics Center, George Washington University, Washington, DC (S.R.E.); the Stroke Unit, Vall d'Hebron Hospital, Barcelona (C.A.M.); and the Department of Neurology, Tiantan Hospital, Capital Medical University, Beijing (Y.W.).""}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Amarenco', 'Affiliation': ""From the Dean's Office, Dell Medical School, University of Texas at Austin, Austin (S.C.J.); the Department of Neurology and Stroke Center, Bichat-Claude Bernard Hospital, University of Paris, Paris (P.A.); Biopharmaceuticals Research and Development, AstraZeneca, Gothenburg (H.D., A.H., M.K., P.L.), and the Department of Medical Sciences, Uppsala University, Uppsala (S.J.) - both in Sweden; the Biostatistics Center, George Washington University, Washington, DC (S.R.E.); the Stroke Unit, Vall d'Hebron Hospital, Barcelona (C.A.M.); and the Department of Neurology, Tiantan Hospital, Capital Medical University, Beijing (Y.W.).""}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Denison', 'Affiliation': ""From the Dean's Office, Dell Medical School, University of Texas at Austin, Austin (S.C.J.); the Department of Neurology and Stroke Center, Bichat-Claude Bernard Hospital, University of Paris, Paris (P.A.); Biopharmaceuticals Research and Development, AstraZeneca, Gothenburg (H.D., A.H., M.K., P.L.), and the Department of Medical Sciences, Uppsala University, Uppsala (S.J.) - both in Sweden; the Biostatistics Center, George Washington University, Washington, DC (S.R.E.); the Stroke Unit, Vall d'Hebron Hospital, Barcelona (C.A.M.); and the Department of Neurology, Tiantan Hospital, Capital Medical University, Beijing (Y.W.).""}, {'ForeName': 'Scott R', 'Initials': 'SR', 'LastName': 'Evans', 'Affiliation': ""From the Dean's Office, Dell Medical School, University of Texas at Austin, Austin (S.C.J.); the Department of Neurology and Stroke Center, Bichat-Claude Bernard Hospital, University of Paris, Paris (P.A.); Biopharmaceuticals Research and Development, AstraZeneca, Gothenburg (H.D., A.H., M.K., P.L.), and the Department of Medical Sciences, Uppsala University, Uppsala (S.J.) - both in Sweden; the Biostatistics Center, George Washington University, Washington, DC (S.R.E.); the Stroke Unit, Vall d'Hebron Hospital, Barcelona (C.A.M.); and the Department of Neurology, Tiantan Hospital, Capital Medical University, Beijing (Y.W.).""}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Himmelmann', 'Affiliation': ""From the Dean's Office, Dell Medical School, University of Texas at Austin, Austin (S.C.J.); the Department of Neurology and Stroke Center, Bichat-Claude Bernard Hospital, University of Paris, Paris (P.A.); Biopharmaceuticals Research and Development, AstraZeneca, Gothenburg (H.D., A.H., M.K., P.L.), and the Department of Medical Sciences, Uppsala University, Uppsala (S.J.) - both in Sweden; the Biostatistics Center, George Washington University, Washington, DC (S.R.E.); the Stroke Unit, Vall d'Hebron Hospital, Barcelona (C.A.M.); and the Department of Neurology, Tiantan Hospital, Capital Medical University, Beijing (Y.W.).""}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'James', 'Affiliation': ""From the Dean's Office, Dell Medical School, University of Texas at Austin, Austin (S.C.J.); the Department of Neurology and Stroke Center, Bichat-Claude Bernard Hospital, University of Paris, Paris (P.A.); Biopharmaceuticals Research and Development, AstraZeneca, Gothenburg (H.D., A.H., M.K., P.L.), and the Department of Medical Sciences, Uppsala University, Uppsala (S.J.) - both in Sweden; the Biostatistics Center, George Washington University, Washington, DC (S.R.E.); the Stroke Unit, Vall d'Hebron Hospital, Barcelona (C.A.M.); and the Department of Neurology, Tiantan Hospital, Capital Medical University, Beijing (Y.W.).""}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Knutsson', 'Affiliation': ""From the Dean's Office, Dell Medical School, University of Texas at Austin, Austin (S.C.J.); the Department of Neurology and Stroke Center, Bichat-Claude Bernard Hospital, University of Paris, Paris (P.A.); Biopharmaceuticals Research and Development, AstraZeneca, Gothenburg (H.D., A.H., M.K., P.L.), and the Department of Medical Sciences, Uppsala University, Uppsala (S.J.) - both in Sweden; the Biostatistics Center, George Washington University, Washington, DC (S.R.E.); the Stroke Unit, Vall d'Hebron Hospital, Barcelona (C.A.M.); and the Department of Neurology, Tiantan Hospital, Capital Medical University, Beijing (Y.W.).""}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Ladenvall', 'Affiliation': ""From the Dean's Office, Dell Medical School, University of Texas at Austin, Austin (S.C.J.); the Department of Neurology and Stroke Center, Bichat-Claude Bernard Hospital, University of Paris, Paris (P.A.); Biopharmaceuticals Research and Development, AstraZeneca, Gothenburg (H.D., A.H., M.K., P.L.), and the Department of Medical Sciences, Uppsala University, Uppsala (S.J.) - both in Sweden; the Biostatistics Center, George Washington University, Washington, DC (S.R.E.); the Stroke Unit, Vall d'Hebron Hospital, Barcelona (C.A.M.); and the Department of Neurology, Tiantan Hospital, Capital Medical University, Beijing (Y.W.).""}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Molina', 'Affiliation': ""From the Dean's Office, Dell Medical School, University of Texas at Austin, Austin (S.C.J.); the Department of Neurology and Stroke Center, Bichat-Claude Bernard Hospital, University of Paris, Paris (P.A.); Biopharmaceuticals Research and Development, AstraZeneca, Gothenburg (H.D., A.H., M.K., P.L.), and the Department of Medical Sciences, Uppsala University, Uppsala (S.J.) - both in Sweden; the Biostatistics Center, George Washington University, Washington, DC (S.R.E.); the Stroke Unit, Vall d'Hebron Hospital, Barcelona (C.A.M.); and the Department of Neurology, Tiantan Hospital, Capital Medical University, Beijing (Y.W.).""}, {'ForeName': 'Yongjun', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""From the Dean's Office, Dell Medical School, University of Texas at Austin, Austin (S.C.J.); the Department of Neurology and Stroke Center, Bichat-Claude Bernard Hospital, University of Paris, Paris (P.A.); Biopharmaceuticals Research and Development, AstraZeneca, Gothenburg (H.D., A.H., M.K., P.L.), and the Department of Medical Sciences, Uppsala University, Uppsala (S.J.) - both in Sweden; the Biostatistics Center, George Washington University, Washington, DC (S.R.E.); the Stroke Unit, Vall d'Hebron Hospital, Barcelona (C.A.M.); and the Department of Neurology, Tiantan Hospital, Capital Medical University, Beijing (Y.W.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1916870']
1300,32656799,"Optimising the value of immunomodulatory drugs during induction and maintenance in transplant ineligible patients with newly diagnosed multiple myeloma: results from Myeloma XI, a multicentre, open-label, randomised, Phase III trial.","Second-generation immunomodulatory agents, such as lenalidomide, have a more favourable side-effect profile than the first-generation thalidomide, but their optimum combination and duration for patients with newly diagnosed transplant-ineligible myeloma (ND-TNE-MM) has not been defined. The most appropriate delivery and dosing regimens of these therapies for patients at advanced age and frailty status is also unclear. The Myeloma XI study compared cyclophosphamide, thalidomide and dexamethasone (CTDa) to cyclophosphamide, lenalidomide and dexamethasone (CRDa) as induction therapy, followed by a maintenance randomisation between ongoing therapy with lenalidomide or observation for patients with ND-TNE-MM. CRDa deepened response but did not improve progression-free (PFS) or overall survival (OS) compared to CTDa. However, analysis by age group highlighted significant differences in tolerability in older, frailer patients that may have limited treatment delivery and impacted outcome. Deeper responses and PFS and OS benefits with CRDa over CTDs were seen in patients aged ≤70 years, with an increase in toxicity and discontinuation observed in older patients. Our results highlight the importance of considering age and frailty in the approach to therapy for patients with ND-TNE-MM, highlighting the need for prospective validation of frailty adapted therapy approaches, which may improve outcomes by tailoring treatment to the individual.",2020,CRDa deepened response but did not improve progression-free (PFS) or overall survival (OS) compared to CTDa.,"['transplant ineligible patients with newly diagnosed multiple myeloma', 'patients with newly diagnosed transplant-ineligible myeloma (ND-TNE-MM', 'patients at advanced age and frailty status', 'patients with ND-TNE-MM', 'patients aged ≤70\xa0years']","['cyclophosphamide, thalidomide and dexamethasone (CTDa) to cyclophosphamide, lenalidomide and dexamethasone (CRDa']","['progression-free (PFS) or overall survival (OS', 'tolerability', 'toxicity and discontinuation']","[{'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0039736', 'cui_str': 'Thalidomide'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C1144149', 'cui_str': 'lenalidomide'}]","[{'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}]",,0.0419444,CRDa deepened response but did not improve progression-free (PFS) or overall survival (OS) compared to CTDa.,"[{'ForeName': 'Graham H', 'Initials': 'GH', 'LastName': 'Jackson', 'Affiliation': 'Northern Institute for Cancer Research, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Pawlyn', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Cairns', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'Alina', 'Initials': 'A', 'LastName': 'Striha', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Collett', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Waterhouse', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Jones', 'Affiliation': 'Kings College Hospital NHS Foundation Trust, London, UK.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Wilson', 'Affiliation': 'Western Sussex Hospitals NHS Foundation Trust, Chichester, UK.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Taylor', 'Affiliation': 'Russells Hall Hospital, Dudley, UK.'}, {'ForeName': 'Bhuvan', 'Initials': 'B', 'LastName': 'Kishore', 'Affiliation': 'University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Mamta', 'Initials': 'M', 'LastName': 'Garg', 'Affiliation': 'Leicester Royal Infirmary, Leicester, UK.'}, {'ForeName': 'Cathy D', 'Initials': 'CD', 'LastName': 'Williams', 'Affiliation': 'Centre for Clinical Haematology, Nottingham University Hospital, Nottingham, UK.'}, {'ForeName': 'Kamaraj', 'Initials': 'K', 'LastName': 'Karunanithi', 'Affiliation': 'University Hospital of North Midlands, Stoke-on-Trent, UK.'}, {'ForeName': 'Jindriska', 'Initials': 'J', 'LastName': 'Lindsay', 'Affiliation': 'E1ast Kent Hospitals University NHS Foundation Trust, Canterbury, UK.'}, {'ForeName': 'Matthew W', 'Initials': 'MW', 'LastName': 'Jenner', 'Affiliation': 'University Hospital Southampton NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Cook', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'Nigel H', 'Initials': 'NH', 'LastName': 'Russell', 'Affiliation': 'Centre for Clinical Haematology, Nottingham University Hospital, Nottingham, UK.'}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Drayson', 'Affiliation': 'Clinical Immunology Service, Institute of Immunology and Immunotherapy, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Martin F', 'Initials': 'MF', 'LastName': 'Kaiser', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Roger G', 'Initials': 'RG', 'LastName': 'Owen', 'Affiliation': ""Haematological Malignancy Diagnostic Service (HMDS), St James's University Hospital, Leeds, UK.""}, {'ForeName': 'Walter M', 'Initials': 'WM', 'LastName': 'Gregory', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'Faith E', 'Initials': 'FE', 'LastName': 'Davies', 'Affiliation': 'Perlmutter Cancer Center, NY Langone Health, New York, NY, USA.'}, {'ForeName': 'Gareth J', 'Initials': 'GJ', 'LastName': 'Morgan', 'Affiliation': 'Perlmutter Cancer Center, NY Langone Health, New York, NY, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",British journal of haematology,['10.1111/bjh.16945']
1301,32662220,Clinical and radiographic comparative study to evaluate the efficacy of restoring destroyed primary incisors using two different techniques-A pilot study.,"OBJECTIVE


The restoration of destroyed maxillary primary incisors is difficult because of the insufficient amount of coronal structure. This pilot study aimed to compare the efficacy of composite posts technique and glass fiber posts technique in restoring destroyed primary incisors.
MATERIALS AND METHODS


Thirty-six destroyed maxillary primary incisors in 11 children with early childhood caries were randomly assigned after endodontic treatment into two groups: glass fiber posts (n = 18) and composite resin posts (n = 18). Blinded clinical evaluation was made at 3, 6, 9, and 12 months and Blinded radiographic evaluation was made at 6 and 12 months. The evaluation was according to the FDI criteria. Data were analyzed with Fisher's exact test (α = .05).
RESULT


After 12 months post-treatment, the success rates were 88.2% in glass fiber posts group and 70.6% in composite resin posts group. There was no statistically significant difference between the two groups according to the evaluation criteria (p-value >.05).
CONCLUSION


Glass fiber posts technique and Composite posts technique may be used in the restoration of destroyed primary incisors.",2020,"There was no statistically significant difference between the two groups according to the evaluation criteria (p-value >.05).
",['Thirty-six destroyed maxillary primary incisors in 11 children with early childhood caries'],"['composite resin posts', 'composite posts technique and glass fiber posts technique', 'glass fiber posts']",['success rates'],"[{'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0021156', 'cui_str': 'Structure of incisor tooth'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C3714731', 'cui_str': 'Early childhood caries'}]","[{'cui': 'C0009570', 'cui_str': 'Composite Resins'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0080038', 'cui_str': 'Post Technic'}, {'cui': 'C0060317', 'cui_str': 'Fiberglass'}]",[],11.0,0.0235983,"There was no statistically significant difference between the two groups according to the evaluation criteria (p-value >.05).
","[{'ForeName': 'Seba', 'Initials': 'S', 'LastName': 'Ibrahim', 'Affiliation': 'Department of Paediatric Dentistry, Faculty of Dentistry, Tishreen University, Syria.'}, {'ForeName': 'Abdul Wahab', 'Initials': 'AW', 'LastName': 'Nourallah', 'Affiliation': 'Department of Paediatric Dentistry, Faculty of Dentistry, Tishreen University, Syria.'}]",Clinical and experimental dental research,['10.1002/cre2.307']
1302,32664877,"Efficacy and safety of cinepazide maleate injection in patients with acute ischemic stroke: a multicenter, randomized, double-blind, placebo-controlled trial.","BACKGROUND


Ischemic stroke is a leading cause of morbidity and mortality. Thrombolytic therapy improves disability and survival rates; however, to be effective, it must be given within 4.5 h of onset. Moreover, thrombolytic therapy is frequently contraindicated. Therefore, alternative therapeutic options are required. In China, cinepazide maleate injection has been shown to improve the cerebral collateral circulation and further reduce disability in stroke patients; however, very few studies investigating this therapy have been conducted to date. Therefore, this study aimed to further confirm the efficacy and safety of cinepazide maleate injection in patients with acute ischemic stroke.
METHODS


Patients with acute ischemic stroke were administered an intravenous infusion of 320 mg cinepazide maleate or placebo once daily for 14 days. All patients were also administered basic therapy (citicoline sodium). The primary efficacy endpoint was the proportion of patients with a modified Rankin scale (mRS) ≤2 on day 90. Secondary efficacy endpoints included Barthel Index ≥95. Safety was evaluated by recording all adverse events (AEs), monitoring laboratory parameters and vital signs, and electrocardiogram.
RESULTS


In total, 937 patients with an acute ischemic stroke were included, with a mean (standard deviation, SD) National Institutes of Health Stroke Scale score of 8.8 (2.4) and a mean (SD) stroke onset of 30.9 (11.4) hours prior. Following treatment for 90 days, the proportion of patients with an mRS score ≤ 2 was significantly higher in the cinepazide maleate group than in the control group (60.9% vs. 50.1%; p = 0.0004). Moreover, the proportion of patients with a Barthel Index of ≥95 on day 90 was also significantly higher in the cinepazide maleate group than in the control group (53.4% vs. 46.7%; p = 0.0230). There were no statistically significant differences in safety parameters between the cinepazide maleate and control groups.
CONCLUSIONS


The results of this study show that cinepazide maleate injection is superior to placebo in improving neurological function and activities of daily living, reducing disability, and promoting functional recovery in patients with acute ischemic stroke. Cinepazide maleate injection was safe and well tolerated with no unexpected AEs reported.
TRIAL REGISTRATION


Chinese Clinical Trial Registry CTR20160292 and ChiCTR1900023827 . Retrospectively registered June 13, 2019.",2020,"Following treatment for 90 days, the proportion of patients with an mRS score ≤ 2 was significantly higher in the cinepazide maleate group than in the control group (60.9% vs. 50.1%; p = 0.0004).","['937 patients with an acute ischemic stroke were included, with a mean (standard deviation, SD) National Institutes of Health Stroke Scale score of 8.8 (2.4) and a mean (SD) stroke onset of 30.9 (11.4) hours prior', 'stroke patients', 'Patients with acute ischemic stroke', 'patients with acute ischemic stroke']","['intravenous infusion of 320\u2009mg cinepazide maleate or placebo', 'Cinepazide maleate injection', 'cinepazide maleate', 'Thrombolytic therapy', 'basic therapy (citicoline sodium', 'cinepazide maleate injection', 'placebo']","['disability and survival rates', 'adverse events (AEs), monitoring laboratory parameters and vital signs, and electrocardiogram', 'safety parameters', 'proportion of patients with an mRS score\u2009≤\u20092', 'Efficacy and safety', 'efficacy and safety', 'neurological function and activities of daily living, reducing disability', 'proportion of patients with a modified Rankin scale (mRS', 'cerebral collateral circulation', 'safe and well tolerated']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4517882', 'cui_str': '8.8'}, {'cui': 'C4517631', 'cui_str': '2.4'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C4517533', 'cui_str': '11.4'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0332152', 'cui_str': 'Before'}]","[{'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}, {'cui': 'C4517711', 'cui_str': '320'}, {'cui': 'C0055741', 'cui_str': 'cinepazide maleate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0040044', 'cui_str': 'Thrombolytic therapy'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3153694', 'cui_str': 'Citicoline sodium'}]","[{'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0027767', 'cui_str': 'Nervous system function'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0009348', 'cui_str': 'Collateral circulation'}]",937.0,0.26888,"Following treatment for 90 days, the proportion of patients with an mRS score ≤ 2 was significantly higher in the cinepazide maleate group than in the control group (60.9% vs. 50.1%; p = 0.0004).","[{'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Ni', 'Affiliation': 'Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, No.1 Shuaifuyuan Wangfujing Dongcheng District, Beijing, 100730, China.'}, {'ForeName': 'Huisheng', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'General Hospital of Northern Theater Command, Shenyang, China.'}, {'ForeName': 'Guofang', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': 'Xuzhou Central Hospital, Xuzhou, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Ji', 'Affiliation': 'Tianjin Huanhu Hospital, Tianjin, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Yi', 'Affiliation': ""Pingxiang People's Hospital, Pingxiang, China.""}, {'ForeName': 'Zhuobo', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Fourth Affiliated Hospital of Harbin Medical University, Harbin, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'First Bethune Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Second Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Xueli', 'Initials': 'X', 'LastName': 'Cai', 'Affiliation': 'Lishui Municipal Central Hospital, Lishui, China.'}, {'ForeName': 'Bei', 'Initials': 'B', 'LastName': 'Shao', 'Affiliation': 'First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China.'}, {'ForeName': 'Jianfeng', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Dalian Municipal Central Hospital, Dalian, China.'}, {'ForeName': 'Yafang', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Huangshi Central Hospital, Huangshi, China.'}, {'ForeName': 'Deqin', 'Initials': 'D', 'LastName': 'Geng', 'Affiliation': 'Affiliated Hospital of Xuzhou Medical University, Xuzhou, China.'}, {'ForeName': 'Xinhui', 'Initials': 'X', 'LastName': 'Qu', 'Affiliation': ""Jiangxi Provincial People's Hospital affiliated to Nanchang University, Nanchang, China.""}, {'ForeName': 'Xiaohong', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Jinan Central Hospital, Jinan, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Wei', 'Affiliation': ""Hengshui People's Hospital (Harrison International Peace Hospital), Hengshui, China.""}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Ding', 'Affiliation': 'Xuan Wu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Lü', 'Affiliation': ""Shaanxi Provincial People's Hospital, Xi'an, China.""}, {'ForeName': 'Yining', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Yonghua', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Seventh Medical Center of the Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Xiao', 'Affiliation': 'Xiangya Hospital Central South University, Changsha, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Gong', 'Affiliation': 'Beijing Hospital, Beijing, China.'}, {'ForeName': 'Liying', 'Initials': 'L', 'LastName': 'Cui', 'Affiliation': 'Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, No.1 Shuaifuyuan Wangfujing Dongcheng District, Beijing, 100730, China. pumchcuily@sina.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMC neurology,['10.1186/s12883-020-01844-8']
1303,32666238,Effect of T-Piece Resuscitator versus Self Inflating Bag on Arterial CO 2  Levels in Preterm Neonates.,"OBJECTIVE


To compare the effect of self-inflating bag (SIB) vs. T-piece resuscitator (TPR) on PaCO 2  levels, when used for brief manual ventilation during administration of first dose of surfactant.
METHODS


Preterm neonates were randomized to receive positive pressure ventilation with either self-inflating bag or T-piece resuscitator during administration of first dose of surfactant. Arterial blood gases were obtained at baseline and 1 h after the intervention. Primary outcome was the mean change in PaCO 2  levels 1 h after the intervention.
RESULTS


Eighty neonates were enrolled (40 in each group). The drop in PaCO 2  at 1 h was significantly greater in the self inflating bag group as compared to the T-piece resuscitator group [8.96 ± 9.06 mmHg vs. 1.37 ± 9.06 mmHg, Mean difference = 7.58 mmHg, (95% CI: 3.78 to 11.4); P < 0.01]. The PaCO 2  change was also statistically significant in the subgroup of infants that required only non-invasive ventilation. The need for second dose of surfactant was higher in the self-inflating bag group [77% vs. 55%, RR - 1.41 (95% CI: 1.02 to 1.94); P = 0.03].
CONCLUSIONS


T-piece resuscitator results in smaller reduction in PaCO 2  levels compared to the self inflating bag, when used for brief manual ventilation during surfactant administration.",2020,"The drop in PaCO 2  at 1 h was significantly greater in the self inflating bag group as compared to the T-piece resuscitator group [8.96 ± 9.06 mmHg vs. 1.37 ± 9.06 mmHg, Mean difference = 7.58 mmHg, (95% CI: 3.78 to 11.4); P < 0.01].","['Preterm neonates', 'Preterm Neonates', 'Eighty neonates were enrolled (40 in each group']","['positive pressure ventilation with either self-inflating bag or T-piece resuscitator during administration of first dose of surfactant', 'self-inflating bag (SIB) vs. T-piece resuscitator (TPR', 'T-Piece Resuscitator versus Self']","['Arterial blood gases', 'mean change in PaCO 2  levels']","[{'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0021778', 'cui_str': 'Intermittent positive pressure ventilation'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0179196', 'cui_str': 'Bag'}, {'cui': 'C0182998', 'cui_str': 'Resuscitator'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0034085', 'cui_str': 'Lung surfactant'}]","[{'cui': 'C0150411', 'cui_str': 'Analysis of arterial blood gases and pH'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0456948', 'cui_str': 'Level 2'}]",80.0,0.188474,"The drop in PaCO 2  at 1 h was significantly greater in the self inflating bag group as compared to the T-piece resuscitator group [8.96 ± 9.06 mmHg vs. 1.37 ± 9.06 mmHg, Mean difference = 7.58 mmHg, (95% CI: 3.78 to 11.4); P < 0.01].","[{'ForeName': 'Amrit', 'Initials': 'A', 'LastName': 'Jeevan', 'Affiliation': ""Division of Neonatology, Surya Children's Hospital, SV Road, Santacruz West, Mumbai, Maharashtra, India.""}, {'ForeName': 'Haribalakrishna', 'Initials': 'H', 'LastName': 'Balasubramanian', 'Affiliation': ""Division of Neonatology, Surya Children's Hospital, SV Road, Santacruz West, Mumbai, Maharashtra, India. doctorhbk@gmail.com.""}, {'ForeName': 'Nandkishor', 'Initials': 'N', 'LastName': 'Kabra', 'Affiliation': ""Division of Neonatology, Surya Children's Hospital, SV Road, Santacruz West, Mumbai, Maharashtra, India.""}]",Indian journal of pediatrics,['10.1007/s12098-020-03393-x']
1304,32666240,Locking compression plate fixation versus intramedullary nailing of humeral shaft fractures: which one is better? A single-centre prospective randomized study.,"PURPOSE


To compare the radiological and clinical outcomes of interlocking nail (ILN) and locking plate fixation (LCP) for humeral shaft fractures.
METHODS


A total of 63 patients with displaced humeral shaft fractures between October 2014 and January 2017 were evaluated prospectively. They were divided randomly into two as LCP fixation (group 1) and interlocking nail (ILN) (group 2). Functional outcomes were evaluated using the Disabilities of the Arm, Shoulder, and Hand (DASH), American Shoulder and Elbow Surgeons (ASES), the University of California at Los Angeles (UCLA) shoulder scores, and Short Form-36 (SF-36) questionnaires, and pain was assessed with visual analogue scale (VAS).
RESULTS


After fracture callus was radiologically observed, DASH, ASES, and UCLA scores as well as SF-36 questionnaires and VAS results were noted to have no significant difference between the two groups (p = 0.109, p = 0.082, p = 0.146, p = 0.322, and p = 0.175, respectively). At the last follow-up (post-operative 24 months), the UCLA score was significantly better in group 1 (p = 0.034), whereas VAS result was significantly worse in group 2 (p = 0.017). DASH, ASES scores, and SF-36 questionnaires had no difference (p = 0.193, p = 0.088, p = 0.289). Other parameters revealed no significant differences. Fracture consolidation was observed at a mean of four months in both groups (3 to 7 months in group 1 and 3 to 8 months in group 2) (p = 0.189). Four patients in group 1 and five patients in group 2 underwent surgery for nonunion (p = 0.725). Post-operative radial nerve palsy was seen in one patient in group 2. Two patients in group 1 with superficial infection were treated with antibiotics, and they recovered.
CONCLUSIONS


Regarding our results, the LCP group had significantly better shoulder function than the ILN group, whereas the ILN group had significantly less pain, with similar complication rates. Therefore, both procedures are favourable surgical options for patients with humeral shaft fractures.",2020,Fracture consolidation was observed at a mean of four months in both groups (3 to 7 months in group 1 and 3 to 8 months in group 2) (p = 0.189).,"['humeral shaft fractures', 'patients with humeral shaft fractures', '63 patients with displaced humeral shaft fractures between October 2014 and January 2017 were evaluated prospectively']","['LCP fixation', 'LCP', 'interlocking nail (ILN) and locking plate fixation (LCP', 'interlocking nail (ILN', 'Locking compression plate fixation versus intramedullary nailing']","['VAS result', 'UCLA score', 'shoulder function', 'Disabilities of the Arm, Shoulder, and Hand (DASH), American Shoulder and Elbow Surgeons (ASES), the University of California at Los Angeles (UCLA) shoulder scores, and Short Form-36 (SF-36) questionnaires, and pain was assessed with visual analogue scale (VAS', 'DASH, ASES scores, and SF-36 questionnaires', 'DASH, ASES, and UCLA scores', 'Fracture consolidation', 'pain', 'SF-36 questionnaires and VAS results']","[{'cui': 'C0588210', 'cui_str': 'Bone structure of shaft of humerus'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}]","[{'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0027342', 'cui_str': 'Nail plate structure'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0021885', 'cui_str': 'Bone nailing'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0521530', 'cui_str': 'Lung consolidation'}]",63.0,0.0209717,Fracture consolidation was observed at a mean of four months in both groups (3 to 7 months in group 1 and 3 to 8 months in group 2) (p = 0.189).,"[{'ForeName': 'Yavuz', 'Initials': 'Y', 'LastName': 'Akalın', 'Affiliation': 'Bursa Yuksek Ihtisas Training and Research Hospital, Department of Orthopaedics and Traumatology, University of Health Sciences, 16310, Yıldırım, Bursa, Turkey. dryakalin@yahoo.com.'}, {'ForeName': 'İsmail Gökhan', 'Initials': 'İG', 'LastName': 'Şahin', 'Affiliation': 'Turkish Ministry of Health, Edirne Sultan 1. Murat Devlet Hastanesi, Department of Orthopaedics and Traumatology, 22100, Edirne, Turkey.'}, {'ForeName': 'Nazan', 'Initials': 'N', 'LastName': 'Çevik', 'Affiliation': 'Bursa Yuksek Ihtisas Training and Research Hospital, Department of Orthopaedics and Traumatology, University of Health Sciences, 16310, Yıldırım, Bursa, Turkey.'}, {'ForeName': 'Burak Olcay', 'Initials': 'BO', 'LastName': 'Güler', 'Affiliation': 'Bursa Yuksek Ihtisas Training and Research Hospital, Department of Orthopaedics and Traumatology, University of Health Sciences, 16310, Yıldırım, Bursa, Turkey.'}, {'ForeName': 'Özgür', 'Initials': 'Ö', 'LastName': 'Avci', 'Affiliation': 'Bursa Yuksek Ihtisas Training and Research Hospital, Department of Orthopaedics and Traumatology, University of Health Sciences, 16310, Yıldırım, Bursa, Turkey.'}, {'ForeName': 'Alpaslan', 'Initials': 'A', 'LastName': 'Öztürk', 'Affiliation': 'Bursa Yuksek Ihtisas Training and Research Hospital, Department of Orthopaedics and Traumatology, University of Health Sciences, 16310, Yıldırım, Bursa, Turkey.'}]",International orthopaedics,['10.1007/s00264-020-04696-6']
1305,32666256,Outcome of a novel modified endoscopic papillectomy for duodenal major papilla adenoma.,"BACKGROUND AND AIMS


In recent years, with the development of endoscopic techniques, endoscopic resection is widely used for duodenal papillary adenomas, but conventional endoscopic resection has a high rate of incomplete resection and recurrence. On this basis, we have employed a novel modified endoscopic papillectomy (ESP). In this study, we evaluated the feasibility and advantages of this ESP for the treatment of duodenal major papilla adenoma.
METHODS


A total of 56 patients with duodenal major papilla adenoma confirmed by endoscopic ultrasonography, intraluminal ultrasound and gastroscopic biopsy from October 2007 to June 2017 were collected in the Department of Gastroenterology, Nanjing Drum Tower Hospital. The diameter of the adenoma ranged from 1.41 to 2.02 cm. 16 cases were given the conventional method and 40 cases underwent the modified ESP procedure in which a small incision was made by cutting current when anchoring the snare tip on the distal side of the adenoma.
RESULTS


En bloc resection rate was significantly higher in the modified group (100%, 40/40) than that in the conventional group (81.3%, 13/16; P = 0.02). However, no significance was seen between the modified group and the conventional group in complete resection rate (92.5%, 37/40 vs 93.8%, 15/16; P = 1.00). There was no significant difference in the number and difficulty of postoperative pancreatic and biliary stents placement between the two groups (P = 0.20). Total bleeding occurrence was much lower in the modified group (37.5%, 15/40 vs 87.5%, 14/16; P = 0.001), and no significant differences were found in other short-term complications and the 3, 6, 12 and 24 months recurrences rate between the conventional and modified ESP groups.
CONCLUSIONS


The modified ESP improves the treatment outcome of duodenal major papilla adenoma with higher en bloc resection rate and lowering bleeding rate.",2020,The modified ESP improves the treatment outcome of duodenal major papilla adenoma with higher en bloc resection rate and lowering bleeding rate.,"['duodenal major papilla adenoma', '56 patients with duodenal major papilla adenoma confirmed by endoscopic ultrasonography, intraluminal ultrasound and gastroscopic biopsy from October 2007 to June 2017 were collected in the Department of Gastroenterology, Nanjing Drum Tower Hospital']","['endoscopic papillectomy (ESP', 'novel modified endoscopic papillectomy', 'modified ESP procedure', 'ESP']","['duodenal major papilla adenoma with higher en bloc resection rate and lowering bleeding rate', 'recurrences rate', 'En bloc resection rate', 'number and difficulty of postoperative pancreatic and biliary stents placement', 'Total bleeding occurrence', 'complete resection rate']","[{'cui': 'C0013303', 'cui_str': 'Duodenal'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0226964', 'cui_str': 'Structure of lingual papillae'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0376443', 'cui_str': 'Endoscopic ultrasonography'}, {'cui': 'C0442115', 'cui_str': 'Intraluminal'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0017163', 'cui_str': 'Gastroenterology'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0013303', 'cui_str': 'Duodenal'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0226964', 'cui_str': 'Structure of lingual papillae'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0030274', 'cui_str': 'Pancreatic structure'}, {'cui': 'C0183512', 'cui_str': 'Biliary stent'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0015250', 'cui_str': 'Complete excision'}]",56.0,0.0169184,The modified ESP improves the treatment outcome of duodenal major papilla adenoma with higher en bloc resection rate and lowering bleeding rate.,"[{'ForeName': 'Pin', 'Initials': 'P', 'LastName': 'Wang', 'Affiliation': 'Department of Gastroenterology, Nanjing Drum Tower Hospital, Affiliated Hospital of Nanjing University Medical School, Nanjing, 210008, Jiangsu, China.'}, {'ForeName': 'Chengfei', 'Initials': 'C', 'LastName': 'Jiang', 'Affiliation': 'Department of Gastroenterology, Affiliated Drum Tower Hospital, Medical School of Nanjing University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Gastroenterology, Nanjing Drum Tower Hospital, Affiliated Hospital of Nanjing University Medical School, Nanjing, 210008, Jiangsu, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Zhou', 'Affiliation': 'Department of Gastroenterology, Nanjing Drum Tower Hospital, Affiliated Hospital of Nanjing University Medical School, Nanjing, 210008, Jiangsu, China.'}, {'ForeName': 'Shu', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Department of Gastroenterology, Nanjing Drum Tower Hospital, Affiliated Hospital of Nanjing University Medical School, Nanjing, 210008, Jiangsu, China.'}, {'ForeName': 'Xiwei', 'Initials': 'X', 'LastName': 'Ding', 'Affiliation': 'Department of Gastroenterology, Nanjing Drum Tower Hospital, Affiliated Hospital of Nanjing University Medical School, Nanjing, 210008, Jiangsu, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Lv', 'Affiliation': 'Department of Gastroenterology, Nanjing Drum Tower Hospital, Affiliated Hospital of Nanjing University Medical School, Nanjing, 210008, Jiangsu, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Gastroenterology, Nanjing Drum Tower Hospital, Affiliated Hospital of Nanjing University Medical School, Nanjing, 210008, Jiangsu, China. 867152094@qq.com.'}, {'ForeName': 'Xiaoping', 'Initials': 'X', 'LastName': 'Zou', 'Affiliation': 'Department of Gastroenterology, Nanjing Drum Tower Hospital, Affiliated Hospital of Nanjing University Medical School, Nanjing, 210008, Jiangsu, China. 13770771661@163.com.'}]",Surgical endoscopy,['10.1007/s00464-020-07715-0']
1306,32687836,Failure of tDCS to modulate motor excitability and speech motor learning.,"Transcranial direct current stimulation (tDCS) modulates cortical excitability in a polarity-specific way and, when used in combination with a behavioural task, it can alter performance. TDCS has the potential, therefore, for use as an adjunct to therapies designed to treat disorders affecting speech, including, but not limited to acquired aphasias and developmental stuttering. For this reason, it is important to conduct studies evaluating its effectiveness and the parameters optimal for stimulation. Here, we aimed to evaluate the effects of bi-hemispheric tDCS over speech motor cortex on performance of a complex speech motor learning task, namely the repetition of tongue twisters. A previous study in older participants showed that tDCS could modulate performance on a similar task. To further understand the effects of tDCS, we also measured the excitability of the speech motor cortex before and after stimulation. Three groups of 20 healthy young controls received: (i) anodal tDCS to the left IFG/LipM1 and cathodal tDCS to the right hemisphere homologue; or (ii) cathodal tDCS over the left and anodal over the right; or (iii) sham stimulation. Participants heard and repeated novel tongue twisters and matched simple sentences before, during and 10 min after the stimulation. One mA tDCS was delivered concurrent with task performance for 13 min. Motor excitability was measured using transcranial magnetic stimulation to elicit motor-evoked potentials in the lip before and immediately after tDCS. The study was double-blind, randomized, and sham-controlled; the design and analysis were pre-registered. Performance on the task improved from baseline to after stimulation but was not significantly modulated by tDCS. Similarly, a small decrease in motor excitability was seen in all three stimulation groups but did not differ among them and was unrelated to task performance. Bayesian analyses provide substantial evidence in support of the null hypotheses in both cases, namely that tongue twister performance and motor excitability were not affected by tDCS. We discuss our findings in the context of the previous positive results for a similar task. We conclude that tDCS may be most effective when brain function is sub-optimal due to age-related declines or pathology. Further study is required to determine why tDCS failed to modulate excitability in the speech motor cortex in the expected ways.",2020,"Similarly, a small decrease in motor excitability was seen in all three stimulation groups but did not differ among them and were unrelated to task performance.","['older participants', '20 healthy young controls received: (i']","['bi-hemispheric tDCS', 'Transcranial direct current stimulation (tDCS', 'TDCS', 'tDCS', 'anodal tDCS to the left IFG/LipM1 and cathodal tDCS to the right hemisphere homologue; or (ii) cathodal tDCS over the left and anodal over the right; or (iii) sham stimulation']","['tongue twister performance and motor excitability', 'motor excitability', 'Motor excitability']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205139', 'cui_str': 'Hemispheric'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0450424', 'cui_str': 'To the left'}, {'cui': 'C0546911', 'cui_str': 'To the right'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0040408', 'cui_str': 'Tongue structure'}, {'cui': 'C0335670', 'cui_str': 'Twister'}, {'cui': 'C0235169', 'cui_str': 'Excitability'}]",20.0,0.046913,"Similarly, a small decrease in motor excitability was seen in all three stimulation groups but did not differ among them and were unrelated to task performance.","[{'ForeName': 'Charlotte E E', 'Initials': 'CEE', 'LastName': 'Wiltshire', 'Affiliation': 'Wellcome Centre for Integrative Neuroimaging, Department of Experimental Psychology, Radcliffe Observatory Quarter, University of Oxford, OX2 6GG, UK. Electronic address: charlotte.wiltshire@psy.ox.ac.uk.'}, {'ForeName': 'Kate E', 'Initials': 'KE', 'LastName': 'Watkins', 'Affiliation': 'Wellcome Centre for Integrative Neuroimaging, Department of Experimental Psychology, Radcliffe Observatory Quarter, University of Oxford, OX2 6GG, UK. Electronic address: kate.watkins@psy.ox.ac.uk.'}]",Neuropsychologia,['10.1016/j.neuropsychologia.2020.107568']
1307,32678131,Clinical efficacy of eyelid hygiene in blepharitis and meibomian gland dysfunction after cataract surgery: a randomized controlled pilot trial.,"The purpose of this randomized clinical trial is to evaluate the effect of eyelid hygiene on subjective symptoms, anterior blepharitis, and meibomian gland dysfunction (MGD) after cataract surgery. Subjects with obstructive MGD who underwent cataract surgery were randomly divided into two groups. In the eyelid hygiene group, eyelid hygiene was performed twice a day for 10 days from 3 days before to 1 week after cataract surgery. The control group did not perform eyelid hygiene. A subjective symptom questionnaire of SPEED, anterior blepharitis grade, and meibum quality and quantity was evaluated at baseline and at postoperative 1 and 4 weeks. The eyelid hygiene group (n = 36) showed decreased SPEED score after cataract surgery and the control group (n = 33) did not. Anterior blepharitis grade was worse 1 week after surgery in the control group but not in the eyelid hygiene group. The control group had significantly decreased meibum quality and quantity in both the upper and lower eyelids after cataract surgery, but the eyelid hygiene group did not. Eyelid hygiene before/after cataract surgery improved postoperative subjective symptoms and prevented postoperative exacerbation of anterior blepharitis and MGD. Thus, perioperative eyelid hygiene is recommended for patients with obstructive MGD who undergo cataract surgery.",2020,"The control group had significantly decreased meibum quality and quantity in both the upper and lower eyelids after cataract surgery, but the eyelid hygiene group did not.","['Subjects with obstructive MGD who underwent cataract surgery', 'patients with obstructive MGD who undergo cataract surgery', 'cataract surgery', 'blepharitis and meibomian gland dysfunction after cataract surgery']",['eyelid hygiene'],"['Anterior blepharitis grade', 'subjective symptoms, anterior blepharitis, and meibomian gland dysfunction (MGD', 'meibum quality and quantity in both the upper and lower eyelids', 'postoperative subjective symptoms', 'subjective symptom questionnaire of SPEED, anterior blepharitis grade, and meibum quality and quantity', 'postoperative exacerbation of anterior blepharitis and MGD', 'eyelid hygiene', 'Eyelid hygiene', 'SPEED score']","[{'cui': 'C1275684', 'cui_str': 'Meibomian gland dysfunction'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005741', 'cui_str': 'Blepharitis'}, {'cui': 'C1306068', 'cui_str': 'Secondary cataract'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0015426', 'cui_str': 'Eyelid structure'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}]","[{'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0005741', 'cui_str': 'Blepharitis'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1275684', 'cui_str': 'Meibomian gland dysfunction'}, {'cui': 'C5197842', 'cui_str': 'Meibomian Lipids'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0229258', 'cui_str': 'Lower eyelid structure'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0015426', 'cui_str': 'Eyelid structure'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0203607,"The control group had significantly decreased meibum quality and quantity in both the upper and lower eyelids after cataract surgery, but the eyelid hygiene group did not.","[{'ForeName': 'Youngsub', 'Initials': 'Y', 'LastName': 'Eom', 'Affiliation': 'Department of Ophthalmology, Korea University Ansan Hospital, Korea University College of Medicine, Gyeonggi-do, South Korea.'}, {'ForeName': 'Kyung Sun', 'Initials': 'KS', 'LastName': 'Na', 'Affiliation': ""Department of Ophthalmology, Yeouido St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, South Korea.""}, {'ForeName': 'Ho Sik', 'Initials': 'HS', 'LastName': 'Hwang', 'Affiliation': ""Department of Ophthalmology, Yeouido St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, South Korea.""}, {'ForeName': 'Kyong Jin', 'Initials': 'KJ', 'LastName': 'Cho', 'Affiliation': 'Department of Ophthalmology, Dankook University College of Medicine, Cheonan, South Korea.'}, {'ForeName': 'Tae-Young', 'Initials': 'TY', 'LastName': 'Chung', 'Affiliation': 'Department of Ophthalmology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Roo Min', 'Initials': 'RM', 'LastName': 'Jun', 'Affiliation': ""Department of Ophthalmology, Ewha Woman's University School of Medicine, Seoul, South Korea.""}, {'ForeName': 'Byung Yi', 'Initials': 'BY', 'LastName': 'Ko', 'Affiliation': 'Department of Ophthalmology, Konyang University College of Medicine, Daejeon, Republic of Korea.'}, {'ForeName': 'Yeoun Sook', 'Initials': 'YS', 'LastName': 'Chun', 'Affiliation': 'Department of Ophthalmology, Chung-Ang University Hospital, Chung-Ang University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Hyun Seung', 'Initials': 'HS', 'LastName': 'Kim', 'Affiliation': ""Department of Ophthalmology, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, South Korea.""}, {'ForeName': 'Jong Suk', 'Initials': 'JS', 'LastName': 'Song', 'Affiliation': 'Department of Ophthalmology, Korea University Guro Hospital, Korea University College of Medicine, Seoul, South Korea. crisim@korea.ac.kr.'}]",Scientific reports,['10.1038/s41598-020-67888-5']
1308,32678132,"Resistance training improves sleep quality, redox balance and inflammatory profile in maintenance hemodialysis patients: a randomized controlled trial.","Patients in maintenance hemodialisys (HD) present sleep disorders, increased inflammation, unbalanced redox profiles, and elevated biomarkers representing endothelial dysfunction. Resistance training (RT) has shown to mitigate the loss of muscle mass, strength, improve inflammatory profiles, and endothelial function while decreasing oxidative stress for those in HD. However, the relation between those factors and sleep quality are inadequately described. The aim of this study was to verify the effects of 3 months of RT on sleep quality, redox balance, nitric oxide (NO) bioavailability, inflammation profile, and asymmetric dimethylarginine (ADMA) in patients undergoing HD. Our primary goal was to describe the role of RT on sleep quality. Our secondary goal was to evaluate the effect of RT on NO, metabolism markers, and inflammatory and redox profiles as potential mechanisms to explain RT-induced sleep quality changes. Fifty-five men undergoing maintenance hemodialysis were randomized into either a control (CTL, n = 25) and RT group (RTG; n = 30). Participants in the RT group demonstrated an improvement in sleep pattern, redox, inflammatory profiles, and biomarkers of endothelial function (NO 2 -  and ADMA). This group also increased muscle strength (total workload in RT exercises of upper and lower limbs). These findings support that RT may improve the clinical status of HD patients by improving their sleep quality, oxidative and inflammatory parameters.",2020,"Participants in the RT group demonstrated an improvement in sleep pattern, redox, inflammatory profiles, and biomarkers of endothelial function (NO 2 -  and ADMA).","['Fifty-five men undergoing maintenance hemodialysis', 'patients undergoing HD', 'maintenance hemodialysis patients']","['control (CTL, n\u2009=\u200925) and RT', 'Resistance training', 'Resistance training (RT']","['sleep pattern, redox, inflammatory profiles, and biomarkers of endothelial function (NO 2 -  and ADMA', 'sleep quality, redox balance, nitric oxide (NO) bioavailability, inflammation profile, and asymmetric dimethylarginine (ADMA', 'muscle strength (total workload in RT exercises of upper and lower limbs', 'sleep quality, redox balance and inflammatory profile', 'sleep quality', 'sleep quality, oxidative and inflammatory parameters']","[{'cui': 'C0450382', 'cui_str': '55'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4040576', 'cui_str': 'Maintenance hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039195', 'cui_str': 'Cytotoxic T lymphocyte'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0474396', 'cui_str': 'Sleep behavior finding'}, {'cui': 'C0030012', 'cui_str': 'Oxidation-reduction'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0067385', 'cui_str': 'N,N-dimethylarginine'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",55.0,0.0171028,"Participants in the RT group demonstrated an improvement in sleep pattern, redox, inflammatory profiles, and biomarkers of endothelial function (NO 2 -  and ADMA).","[{'ForeName': 'Hugo Luca', 'Initials': 'HL', 'LastName': 'Corrêa', 'Affiliation': 'Graduate Program of Physical Education, Catholic University of Brasilia (USB), EPTC, QS07, LT1 s/n. Bloco G Sala 117, Águas Claras, Taguatinga, Brasília, DF, 71966-700, Brazil. hugo.efucb@gmail.com.'}, {'ForeName': 'Sting Ray Gouveia', 'Initials': 'SRG', 'LastName': 'Moura', 'Affiliation': 'Graduate Program of Physical Education, Catholic University of Brasilia (USB), EPTC, QS07, LT1 s/n. Bloco G Sala 117, Águas Claras, Taguatinga, Brasília, DF, 71966-700, Brazil.'}, {'ForeName': 'Rodrigo Vanerson Passos', 'Initials': 'RVP', 'LastName': 'Neves', 'Affiliation': 'Graduate Program of Physical Education, Catholic University of Brasilia (USB), EPTC, QS07, LT1 s/n. Bloco G Sala 117, Águas Claras, Taguatinga, Brasília, DF, 71966-700, Brazil.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Tzanno-Martins', 'Affiliation': 'HDC RenalClass, São Paulo, SP, Brazil.'}, {'ForeName': 'Michel Kendy', 'Initials': 'MK', 'LastName': 'Souza', 'Affiliation': 'Department of Nephrology, Federal University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Anderson Sola', 'Initials': 'AS', 'LastName': 'Haro', 'Affiliation': 'Department of Nephrology, Federal University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Costa', 'Affiliation': 'Department of Nephrology, Federal University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'José Adeirton Bezerra', 'Initials': 'JAB', 'LastName': 'Silva', 'Affiliation': 'HDC RenalClass, São Paulo, SP, Brazil.'}, {'ForeName': 'Whitley', 'Initials': 'W', 'LastName': 'Stone', 'Affiliation': 'School of Kinesiology, Recreation, and Sport, Western Kentucky University, Bowling Green, KY, USA.'}, {'ForeName': 'Fernando Sousa', 'Initials': 'FS', 'LastName': 'Honorato', 'Affiliation': 'Graduate Program of Physical Education, Catholic University of Brasilia (USB), EPTC, QS07, LT1 s/n. Bloco G Sala 117, Águas Claras, Taguatinga, Brasília, DF, 71966-700, Brazil.'}, {'ForeName': 'Lysleine Alves', 'Initials': 'LA', 'LastName': 'Deus', 'Affiliation': 'Graduate Program of Physical Education, Catholic University of Brasilia (USB), EPTC, QS07, LT1 s/n. Bloco G Sala 117, Águas Claras, Taguatinga, Brasília, DF, 71966-700, Brazil.'}, {'ForeName': 'Jonato', 'Initials': 'J', 'LastName': 'Prestes', 'Affiliation': 'Graduate Program of Physical Education, Catholic University of Brasilia (USB), EPTC, QS07, LT1 s/n. Bloco G Sala 117, Águas Claras, Taguatinga, Brasília, DF, 71966-700, Brazil.'}, {'ForeName': 'Herbert Gustavo', 'Initials': 'HG', 'LastName': 'Simões', 'Affiliation': 'Graduate Program of Physical Education, Catholic University of Brasilia (USB), EPTC, QS07, LT1 s/n. Bloco G Sala 117, Águas Claras, Taguatinga, Brasília, DF, 71966-700, Brazil.'}, {'ForeName': 'Elaine Cristina', 'Initials': 'EC', 'LastName': 'Vieira', 'Affiliation': 'Graduate Program of Physical Education, Catholic University of Brasilia (USB), EPTC, QS07, LT1 s/n. Bloco G Sala 117, Águas Claras, Taguatinga, Brasília, DF, 71966-700, Brazil.'}, {'ForeName': 'Gislane Ferreira', 'Initials': 'GF', 'LastName': 'de Melo', 'Affiliation': 'Graduate Program of Physical Education, Catholic University of Brasilia (USB), EPTC, QS07, LT1 s/n. Bloco G Sala 117, Águas Claras, Taguatinga, Brasília, DF, 71966-700, Brazil.'}, {'ForeName': 'Milton Rocha', 'Initials': 'MR', 'LastName': 'Moraes', 'Affiliation': 'Graduate Program of Physical Education, Catholic University of Brasilia (USB), EPTC, QS07, LT1 s/n. Bloco G Sala 117, Águas Claras, Taguatinga, Brasília, DF, 71966-700, Brazil.'}, {'ForeName': 'Thiago Santos', 'Initials': 'TS', 'LastName': 'Rosa', 'Affiliation': 'Graduate Program of Physical Education, Catholic University of Brasilia (USB), EPTC, QS07, LT1 s/n. Bloco G Sala 117, Águas Claras, Taguatinga, Brasília, DF, 71966-700, Brazil.'}]",Scientific reports,['10.1038/s41598-020-68602-1']
1309,32678200,Individual versus team heart rate variability responsiveness analyses in a national soccer team during training camps.,"Heart rate variability (HRV) analyses can be performed using group or individual changes. Individual changes could be of potential interest during training camps for national soccer teams. The purpose of this study was to compare whether analysis of individual daily HRV could detect changes in cardiac autonomic responses during training camps for national soccer teams. During two different training camps, 34 professional soccer players were monitored daily over 9 days, using heart rate monitors. Players were divided into First Eleven (those who participated in the main squad) or Reserves. Daily HRV was individually analyzed using a day-to-day method or a baseline (days prior to first match) method, using the smallest worthwhile change and the typical error in the estimate to establish a trivial (random change) zone. Group changes were also analyzed using an ANOVA one-way repeated measures test. Players' responsiveness was classified as High-, Low- or Non-response depending on individual changes. Both analyses showed substantial daily individual changes after playing a soccer match, regardless of the group. However, group changes showed that only First Eleven players had significant changes after playing a soccer match. In conclusion, individual daily HRV analyses are useful in detecting individual changes in professional soccer players.",2020,"Both analyses showed substantial daily individual changes after playing a soccer match, regardless of the group.","['Players were divided into First Eleven (those who participated in the main squad) or Reserves', 'national soccer teams', 'professional soccer players', '34 professional soccer players']",[],"['Daily HRV', 'Heart rate variability (HRV) analyses', 'cardiac autonomic responses']","[{'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}]",[],"[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}]",34.0,0.0198656,"Both analyses showed substantial daily individual changes after playing a soccer match, regardless of the group.","[{'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Muñoz-López', 'Affiliation': 'Departamento de Motricidad Humana y Rendimiento Deportivo, Education Sciences School, University of Seville, Desk 4.78, c/Pirotecnica s/n, 41013, Seville, Spain. amunlop@gmail.com.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Naranjo-Orellana', 'Affiliation': 'Sports and Computers Department, University Pablo de Olavide, Seville, Spain.'}]",Scientific reports,['10.1038/s41598-020-68698-5']
1310,32662280,Integrating the Early Start Denver Model into Israeli community autism spectrum disorder preschools: Effectiveness and treatment response predictors.,"LAY ABSTRACT


Early intensive intervention has been shown to significantly affect the development of children with Autism. However, the costly implementation of such interventions limits their wide dissemination in the community. This study examined an integration of a research-supported early intensive intervention model called the Early Start Denver Model into community preschool programs for children with Autism in Israel. Four community preschools implemented the preschool-based Early Start Denver Model and four implemented the existing multidisciplinary developmental intervention which is widely applied in Israeli community preschools for children with autism. Fifty-one children (aged 33-57 months) participated in the study. Twenty-six attended the preschool-based Early Start Denver Model preschools and twenty-five attended the multidisciplinary developmental intervention preschools. Before the intervention began, groups were comparable on children's age and developmental functioning and on families' socio-economic status. Results showed that, compared to the multidisciplinary developmental intervention group, children in the preschool-based Early Start Denver Model treatment group made greater gains on measures of overall cognitive development, language skills, as well as on parent- and teacher-reported adaptive communication and socialization abilities. Children who had lower autism symptom severity, higher adaptive functioning and better language understanding abilities before taking part in the preschool-based Early Start Denver Model program showed greater improvements following it. This study documents the successful implementation of an intensive early intervention program in pre-existing community preschools, underlining the importance of the integration of research-supported intervention programs into community settings.",2020,"Before the intervention began, groups were comparable on children's age and developmental functioning and on families' socio-economic status.","['children with Autism in Israel', 'children with autism', 'children with Autism', 'Fifty-one children (aged 33-57\u2009months) participated in the study', 'Twenty-six attended the preschool-based Early Start Denver Model preschools and twenty-five attended the multidisciplinary developmental intervention preschools']",['intensive early intervention program'],"['overall cognitive development, language skills, as well as on parent- and teacher-reported adaptive communication and socialization abilities', 'adaptive functioning and better language understanding abilities']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0022271', 'cui_str': 'Israel'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0458003', 'cui_str': 'Developmental'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0242687', 'cui_str': 'Provision of early intervention service for child'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0037447', 'cui_str': 'Socialization'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}]",51.0,0.0150567,"Before the intervention began, groups were comparable on children's age and developmental functioning and on families' socio-economic status.","[{'ForeName': 'Yana', 'Initials': 'Y', 'LastName': 'Sinai-Gavrilov', 'Affiliation': 'Bar-Ilan University, Israel.'}, {'ForeName': 'Tali', 'Initials': 'T', 'LastName': 'Gev', 'Affiliation': 'Bar-Ilan University, Israel.'}, {'ForeName': 'Irit', 'Initials': 'I', 'LastName': 'Mor-Snir', 'Affiliation': 'The Association for Children at Risk, Israel.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Vivanti', 'Affiliation': 'Drexel University, USA.'}, {'ForeName': 'Ofer', 'Initials': 'O', 'LastName': 'Golan', 'Affiliation': 'Bar-Ilan University, Israel.'}]",Autism : the international journal of research and practice,['10.1177/1362361320934221']
1311,32687804,"Safety and immunogenicity of the live attenuated intranasal pertussis vaccine BPZE1: a phase 1b, double-blind, randomised, placebo-controlled dose-escalation study.","BACKGROUND


Long-term protection and herd immunity induced by existing pertussis vaccines are imperfect, and a need therefore exists to develop new pertussis vaccines. This study aimed to investigate the safety, colonisation, and immunogenicity of the new, live attenuated pertussis vaccine, BPZE1, when given intranasally.
METHODS


This phase 1b, double-blind, randomised, placebo-controlled, dose-escalation study was done at the phase 1 unit, Karolinska Trial Alliance, Karolinska University Hospital, Stockholm, Sweden. Healthy adults (18-32 years) were screened and included sequentially into three groups of increasing BPZE1 dose strength (10 7  colony-forming units [CFU], 10 8  CFU, and 10 9  CFU), and were randomly assigned (3:1 within each group) to receive vaccine or placebo. Vaccine and placebo were administered in phosphate-buffered saline contained 5% saccharose as 0·4 mL in each nostril. The primary outcome was solicited and unsolicited adverse events between day 0 and day 28. The analysis included all randomised participants who received a vaccine dose. Colonisation with BPZE1 was determined by repeatedly culturing nasopharyngeal aspirates at day 4, day 7, day 11, day 14, day 21, and day 28 after vaccination. Immunogenicity, as serum IgG and IgA responses were assessed at day 0, day 7, day 14, day 21, day 28, 6 months, and 12 months after vaccination. This trial is registered at Clinicaltrials.gov, NCT02453048.
FINDINGS


Between Sept 1, 2015, and Feb 3, 2016, 120 participants were assessed for eligibility, 48 of whom were enrolled and randomly assigned (3:1) to receive vaccine or placebo, with 12 participants each in a low-dose, medium-dose, and high-dose vaccine group. Adverse events between day 0 and day 28 were reported by one (8%, 95% CI 0-39) of 12 participants in both the placebo and low-dose groups, and two (17%; 2-48) of 12 participants in both the medium-dose and high-dose groups, including cough of grade 2 or more, oropharyngeal pain, and rhinorrhoea and nasal congestion. During this time, none of the participants experienced any spasmodic cough, difficulties in breathing, or adverse events following immunisation concerning vital signs. The tested doses of BPZE1 or placebo were well tolerated, with no apparent difference in solicited or unsolicited adverse events following immunisation between groups. Colonisation at least once after vaccination was observed in 29 (81%; 68-93) of 36 vaccinated participants. The tested vaccine doses were immunogenic, with increases in serum IgG and IgA titres against the four B pertussis antigens from baseline to 12 months.
INTERPRETATION


The tested vaccine was safe, induced a high colonisation rate in an adult population, and was immunogenic at all doses. These findings justify further clinical development of BPZE1 to ultimately be used as a priming vaccine for neonates or a booster vaccine for adolescents and adults, or both.
FUNDING


ILiAD Biotechnologies.",2020,"The tested vaccine doses were immunogenic, with increases in serum IgG and IgA titres against the four B pertussis antigens from baseline to 12 months.
","['Between Sept 1, 2015, and Feb 3, 2016, 120 participants were assessed for eligibility, 48 of whom were enrolled and randomly assigned (3:1) to receive', 'Healthy adults (18-32 years']","['vaccine or placebo', 'BPZE1 or placebo', 'Vaccine and placebo', 'live attenuated intranasal pertussis vaccine BPZE1', 'phosphate-buffered saline contained 5% saccharose as 0·4', 'placebo']","['spasmodic cough, difficulties in breathing, or adverse events', 'Safety and immunogenicity', 'Adverse events', 'Immunogenicity, as serum IgG and IgA responses', 'solicited and unsolicited adverse events', 'safety, colonisation, and immunogenicity', 'cough of grade 2 or more, oropharyngeal pain, and rhinorrhoea and nasal congestion', 'serum IgG and IgA titres', 'solicited or unsolicited adverse events', 'Colonisation']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0031237', 'cui_str': 'Pertussis Vaccine'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}]","[{'cui': 'C0277870', 'cui_str': 'Spasmodic cough'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C2363731', 'cui_str': 'Oropharyngeal pain'}, {'cui': 'C1260880', 'cui_str': 'Nasal discharge'}, {'cui': 'C0027424', 'cui_str': 'Nasal congestion'}, {'cui': 'C0475208', 'cui_str': 'Titer'}]",120.0,0.664209,"The tested vaccine doses were immunogenic, with increases in serum IgG and IgA titres against the four B pertussis antigens from baseline to 12 months.
","[{'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'Jahnmatz', 'Affiliation': 'Public Health Agency of Sweden, Solna, Sweden.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Richert', 'Affiliation': 'University of Bordeaux, National Institute for Health and Medical Research (Inserm), Bordeaux Population Health Research Center, Bordeaux, France; University Hospital Centre CHU, Bordeaux, France; EUCLID/F-CRIN Clinical Trials Platform, Bordeaux, France; Inria SISTM team, F-33405, Talence, France.'}, {'ForeName': 'Nabil', 'Initials': 'N', 'LastName': 'Al-Tawil', 'Affiliation': 'Karolinska Trial Alliance, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Jann', 'Initials': 'J', 'LastName': 'Storsaeter', 'Affiliation': 'Public Health Agency of Sweden, Solna, Sweden.'}, {'ForeName': 'Céline', 'Initials': 'C', 'LastName': 'Colin', 'Affiliation': 'University of Bordeaux, National Institute for Health and Medical Research (Inserm), Bordeaux Population Health Research Center, Bordeaux, France; University Hospital Centre CHU, Bordeaux, France; EUCLID/F-CRIN Clinical Trials Platform, Bordeaux, France.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Bauduin', 'Affiliation': 'University of Bordeaux, National Institute for Health and Medical Research (Inserm), Bordeaux Population Health Research Center, Bordeaux, France; University Hospital Centre CHU, Bordeaux, France; EUCLID/F-CRIN Clinical Trials Platform, Bordeaux, France.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Thalen', 'Affiliation': 'ILiAD Biotechnologies, New York, NY, USA.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Solovay', 'Affiliation': 'ILiAD Biotechnologies, New York, NY, USA.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Rubin', 'Affiliation': 'ILiAD Biotechnologies, New York, NY, USA.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Mielcarek', 'Affiliation': 'University of Lille, National Centre for Scientific Research (CNRS), National Institute for Health and Medical Research (Inserm), University Hospital Centre CHU Lille, Lille, France; Center for Infection and Immunity of Lille, Institut Pasteur de Lille, Lille, France.'}, {'ForeName': 'Rigmor', 'Initials': 'R', 'LastName': 'Thorstensson', 'Affiliation': 'Public Health Agency of Sweden, Solna, Sweden.'}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Locht', 'Affiliation': 'University of Lille, National Centre for Scientific Research (CNRS), National Institute for Health and Medical Research (Inserm), University Hospital Centre CHU Lille, Lille, France; Center for Infection and Immunity of Lille, Institut Pasteur de Lille, Lille, France. Electronic address: camille.locht@pasteur-lille.fr.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(20)30274-7']
1312,32678055,"10-year follow-up results of the prospective, double-blinded, randomized, controlled study on autologous bone marrow buffy coat grafting combined with core decompression in patients with avascular necrosis of the femoral head.","BACKGROUND


Avascular necrosis of the femoral head (ANFH) is a severely disabling disease of the hip. Several clinical trials have shown promising outcomes on the use of mesenchymal stem cells for the treatment of ANFH, but long-term clinical assessments are lacking. Previously, we reported the 2-year follow-up results of a prospective, double-blinded, randomized, controlled study on autologous bone marrow buffy coat grafting combined with core decompression in patients with ANFH. Here, we report the 10-year follow-up results of this study.
METHODS


We recruited 43 (53 hips) patients from 2009 to 2010. The hips were randomly allocated to code decompression (CD) with or without bone marrow buffy coat (BBC) grafting. Participants underwent follow-up at 24, 60, and 120 months postoperatively. The visual analogue scale (VAS), Lequesne algofunctional index, and Western Ontario and McMaster Universities Arthritis Index (WOMAC) osteoarthritis scores were recorded. Survival rate analysis and prognostic factor analysis were performed. The endpoint was defined as progression to Ficat stage IV or conversion to hip arthroplasty.
RESULTS


A total of 31 patients (41 hips) were included in the final analysis. The CD + BBC group had better subjective assessment scores than the CD group. The average survival times were 102.3 months and 78.1 months in the CD + BBC group and CD group, respectively (log-rank test, P = 0.029). In the univariate Cox proportional hazards regression model, age [hazard ratio (HR) = 1.079, P = 0.047] and preoperative Ficat stage (HR = 3.283, P = 0.028) indicated a high risk for progression, while the use of BBC (HR = 0.332, P = 0.042) indicated a low risk. Preoperative Ficat stage III was isolated as an independent risk factor for clinical failure in the multivariate model (HR = 3.743, P = 0.018).
CONCLUSION


The 10-year follow-up results of this prospective, double-blinded, randomized, controlled study showed that the use of autologous BBC in combination with core decompression was more effective than the use of core decompression alone.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT01613612 . Registered on 13 December 2011-retrospectively registered.",2020,"The average survival times were 102.3 months and 78.1 months in the CD + BBC group and CD group, respectively (log-rank test, P = 0.029).","['31 patients (41 hips', 'patients with avascular necrosis of the femoral head', 'We recruited 43 (53 hips) patients from 2009 to 2010', 'patients with ANFH']","['autologous BBC', 'code decompression (CD) with or without bone marrow buffy coat (BBC) grafting', 'CD + BBC', 'autologous bone marrow buffy coat grafting combined with core decompression']","['preoperative Ficat stage', 'visual analogue scale (VAS), Lequesne algofunctional index, and Western Ontario and McMaster Universities Arthritis Index (WOMAC) osteoarthritis scores', 'average survival times', 'subjective assessment scores', 'progression to Ficat stage IV or conversion to hip arthroplasty']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0410480', 'cui_str': 'Avascular necrosis of the head of femur'}]","[{'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C0443089', 'cui_str': 'Leukocyte buffy coat'}, {'cui': 'C0009219', 'cui_str': 'Coding'}, {'cui': 'C0011117', 'cui_str': 'Decompression'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0444669', 'cui_str': 'Core'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0451868', 'cui_str': 'Localized osteoporosis - Lequesne'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0003864', 'cui_str': 'Arthritis'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0186193', 'cui_str': 'Repair of hip'}]",31.0,0.241733,"The average survival times were 102.3 months and 78.1 months in the CD + BBC group and CD group, respectively (log-rank test, P = 0.029).","[{'ForeName': 'Mengyuan', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': ""Division of Joint Osteopathy and Traumatology, Center of Orthopedics Surgery, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, School of Medicine, South China University of Technology, 106 Zhongshan 2nd Road, Yuexiu District, Guangzhou, 510080, People's Republic of China.""}, {'ForeName': 'Yuanchen', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': ""Division of Joint Osteopathy and Traumatology, Center of Orthopedics Surgery, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, School of Medicine, South China University of Technology, 106 Zhongshan 2nd Road, Yuexiu District, Guangzhou, 510080, People's Republic of China.""}, {'ForeName': 'Guangtao', 'Initials': 'G', 'LastName': 'Fu', 'Affiliation': ""Division of Joint Osteopathy and Traumatology, Center of Orthopedics Surgery, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, School of Medicine, South China University of Technology, 106 Zhongshan 2nd Road, Yuexiu District, Guangzhou, 510080, People's Republic of China.""}, {'ForeName': 'Ruiying', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': ""Division of Joint Osteopathy and Traumatology, Center of Orthopedics Surgery, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, School of Medicine, South China University of Technology, 106 Zhongshan 2nd Road, Yuexiu District, Guangzhou, 510080, People's Republic of China.""}, {'ForeName': 'Qingtian', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': ""Division of Joint Osteopathy and Traumatology, Center of Orthopedics Surgery, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, School of Medicine, South China University of Technology, 106 Zhongshan 2nd Road, Yuexiu District, Guangzhou, 510080, People's Republic of China.""}, {'ForeName': 'Zhantao', 'Initials': 'Z', 'LastName': 'Deng', 'Affiliation': ""Division of Joint Osteopathy and Traumatology, Center of Orthopedics Surgery, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, School of Medicine, South China University of Technology, 106 Zhongshan 2nd Road, Yuexiu District, Guangzhou, 510080, People's Republic of China.""}, {'ForeName': 'Minghao', 'Initials': 'M', 'LastName': 'Zheng', 'Affiliation': 'Centre for Orthopaedic Translational Research, School of Surgery, The University of Western Australia, M Block, QE2 Medical Centre, Monash Ave., Nedlands, WA, 6009, Australia. Minghao.zheng@uwa.edu.au.'}, {'ForeName': 'Qiujian', 'Initials': 'Q', 'LastName': 'Zheng', 'Affiliation': ""Division of Joint Osteopathy and Traumatology, Center of Orthopedics Surgery, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, School of Medicine, South China University of Technology, 106 Zhongshan 2nd Road, Yuexiu District, Guangzhou, 510080, People's Republic of China. zhengqiujian@gdph.org.cn.""}]",Stem cell research & therapy,['10.1186/s13287-020-01810-8']
1313,32673215,Sun Safe Partners Online: Pilot Randomized Controlled Clinical Trial.,"BACKGROUND


Harnessing supportive influences in close relationships is an innovative and potentially effective strategy to improve sun protection behaviors.
OBJECTIVE


This pilot randomized controlled clinical trial evaluates the feasibility and impact of Sun Safe Partners Online, a web-based, couples-focused intervention to improve sun protection behavior.
METHODS


A total of 75 couples reporting suboptimal levels of sun protection recruited from Facebook advertisements were randomized to receive a web-based intervention called Sun Safe Partners Online or a Generic Online Sun Safety Information intervention. Sun Safe Partners Online had 4 individual-focused modules and 4 couples-focused modules. Feasibility was assessed by study enrollment, engagement, follow-up survey completion, and intervention evaluation. Participants completed baseline and a 1-month postintervention survey assessing sun protection and exposure, along with individual and relationship attitudes about the importance of sun protection.
RESULTS


Using Facebook as a recruitment strategy resulted in rapid enrollment and higher acceptance than for the prior telephone and print trial. The follow-up survey completion was higher in the Generic Online condition (100%) than in the Sun Safe Partners Online condition (87.2%). Engagement in Sun Safe Partners Online was high, with more than two-thirds of participants completing all modules. Evaluations of Sun Safe Partners Online content and features as well as ease of navigation were excellent. Sun Safe Partners Online showed small effects on sun protection behaviors and sun exposure on weekends compared with the Generic Online intervention and moderate effect size increases in the Sun Safe Partners Online condition.
CONCLUSIONS


This study uses a novel approach to facilitate engagement in sun protection by harnessing the influence of relationships among spouses and cohabiting partners. A couples-focused intervention may hold promise as a means to improve sun protection behaviors beyond interventions focused solely on individuals by leveraging the concern, collaboration, and support among intimate partners and addressing relationship-based barriers to sun protection.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04549675; https://clinicaltrials.gov/ct2/show/NCT04549675.",2020,"Sun Safe Partners Online showed small effects on sun protection behaviors and sun exposure on weekends compared with the Generic Online intervention and moderate effect size increases in the Sun Safe Partners Online condition.
","['Sun Safe Partners Online', 'spouses and co-habiting partners', 'Seventy five couples reporting suboptimal levels of sun protection recruited from Facebook advertisements']","['web-based intervention called Sun Safe Partners Online or a Generic Online Sun Safety Information intervention', 'Sun Safe Partners Online, an online, couple-focused intervention']",[],"[{'cui': 'C0038817', 'cui_str': 'Sunlight'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0162409', 'cui_str': 'Spouse'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C4319621', 'cui_str': '75'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}]","[{'cui': 'C3898714', 'cui_str': 'Internet Intervention'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0038817', 'cui_str': 'Sunlight'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}]",[],75.0,0.170333,"Sun Safe Partners Online showed small effects on sun protection behaviors and sun exposure on weekends compared with the Generic Online intervention and moderate effect size increases in the Sun Safe Partners Online condition.
","[{'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Manne', 'Affiliation': 'Rutgers Cancer Institute of New Jersey, New Brunswick, NJ, United States.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Buller', 'Affiliation': 'Klein Buendel, Inc, Golden, CO, United States.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Devine', 'Affiliation': 'Rutgers Cancer Institute of New Jersey, New Brunswick, NJ, United States.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Heckman', 'Affiliation': 'Rutgers Cancer Institute of New Jersey, New Brunswick, NJ, United States.'}, {'ForeName': 'Sherry', 'Initials': 'S', 'LastName': 'Pagoto', 'Affiliation': 'University of Connecticut, Storrs, CT, United States.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Frederick', 'Affiliation': 'Rutgers Cancer Institute of New Jersey, New Brunswick, NJ, United States.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Mitarotondo', 'Affiliation': 'Rutgers Cancer Institute of New Jersey, New Brunswick, NJ, United States.'}]",Journal of medical Internet research,['10.2196/18037']
1314,32662160,The Effects of a Community Animation Program in a Rural Setting on the Participants' Quality of Life.,"BACKGROUND


This study presents the evaluation of a Community Animation Program (CAP) conducted in a rural town in Spain aimed towards improving the participants' Quality of Life. The program includes animation, culture, and leisure activities to improve not only the inhabitants' Subjective Quality of Life but also social cohesion and enhance a sense of community belonging.
METHODS


A repeated measure pre/post-test design with an experimental and equivalent control group (55 participants per group) was used to evaluate the efficacy of the Program. Instruments included measures of Quality and Satisfaction of Life, Happiness, Positive and Negative Affect, Mental Health, Self-esteem, Loneliness and Community Support. The number of participants practically included the whole universe of town members participating in community activities.
RESULTS


The program improved the participants' Quality of Life, with a stronger impact on the relational, community and environmental dimensions as well as psychological wellbeing. Community animation prevents isolation and loneliness and creates social cohesion. Social interactions improve life satisfaction of the participants.
CONCLUSION


The CAP enhances integration, leisure and interaction and generates more positive affect, happiness and social wellbeing. Promoting recreation centres and programs in rural settings may improve inhabitants' health and general wellbeing as well as enhancing social connectedness.",2020,"The program improved the participants' Quality of Life, with a stronger impact on the relational, community and environmental dimensions as well as psychological wellbeing.",['participants practically included the whole universe of town members participating in community activities'],"['Community Animation Program', 'Community Animation Program (CAP']","[""participants' Quality of Life"", 'isolation and loneliness and creates social cohesion', 'Quality and Satisfaction of Life, Happiness, Positive and Negative Affect, Mental Health, Self-esteem, Loneliness and Community Support', 'Subjective Quality of Life but also social cohesion and enhance a sense of community belonging', 'relational, community and environmental dimensions as well as psychological wellbeing', 'CAP enhances integration, leisure and interaction and generates more positive affect, happiness and social wellbeing', 'life satisfaction']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0557750', 'cui_str': 'Town environment'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0376650', 'cui_str': 'Animation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0037421', 'cui_str': 'Social isolation'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0376650', 'cui_str': 'Animation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0086542', 'cui_str': 'Leisure'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C3696958', 'cui_str': 'Social wellbeing'}]",,0.0282144,"The program improved the participants' Quality of Life, with a stronger impact on the relational, community and environmental dimensions as well as psychological wellbeing.","[{'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Ubillos-Landa', 'Affiliation': 'University of Burgos, Burgos, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Hortigüela-Arroyo', 'Affiliation': 'Community Development Programmer, Burgos, Spain.'}, {'ForeName': 'José Luis', 'Initials': 'JL', 'LastName': 'González-Castro', 'Affiliation': 'University of Burgos, Burgos, Spain.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Puente-Martinez', 'Affiliation': 'Universidad del País Vasco, avda. Tolosa, Donostia, Spain.'}]",Applied psychology. Health and well-being,['10.1111/aphw.12204']
1315,32665479,A Positive Psychology-Motivational Interviewing Intervention to Promote Positive Affect and Physical Activity in Type 2 Diabetes: The BEHOLD-8 Controlled Clinical Trial.,"OBJECTIVE


Physical activity is associated with superior health outcomes in patients with type 2 diabetes (T2D), but most T2D patients do not follow physical activity recommendations. The objective of this study was to assess the feasibility and impact of a novel combined positive psychology-motivational interviewing (PP-MI) intervention to promote physical activity in T2D.
METHODS


This controlled clinical trial compared an 8-week, phone-delivered PP-MI intervention to an attention-matched MI-enhanced behavioral counseling condition among 60 participants with T2D and suboptimal moderate to vigorous physical activity (MVPA; <150 min/wk). The primary study outcome was feasibility (proportion of sessions completed) and acceptability (0-10 ease and utility ratings of each session). Secondary outcomes were between-group differences in changes in positive affect (main psychological outcome) and accelerometer-measured physical activity (MVPA and steps per day), using mixed-effects regression models, at 8 and 16 weeks.
RESULTS


Ninety-two percent of PP-MI sessions were completed, and mean participant ratings of ease/utility were 8.5 to 8.8/10, surpassing a priori benchmarks for feasibility and acceptability. PP-MI participants had small-medium effect size (ES) difference improvements in positive affect compared with MI (8 weeks: estimated mean difference [EMD] = 3.07 [SE = 1.41], p = .029, ES = 0.44; 16 weeks: EMD = 2.92 [SE = 1.73], p = .092, ES = 0.42). PP-MI participants also had greater improvements in MVPA (8 weeks: EMD = 13.05 min/d [SE = 5.00], p = .009, ES = 1.24; 16 weeks: EMD = 7.96 [SE = 4.53], p = .079, ES = 0.75), with similar improvements in steps per day.
CONCLUSIONS


The PP-MI intervention was feasible and well accepted. Next-step efficacy studies can more rigorously explore the intervention's effects on physical activity and clinical outcomes.
TRIAL REGISTRATION


ClinicalTrials.gov Registration No. NCT03150199.",2020,"PP-MI participants also had greater improvements in MVPA (8 weeks: EMD 13.05 minutes/day [SE 5.00], p=.009, ES=1.24; 16 weeks: EMD 7.96 [SE 4.53], p=.079, ES=.75), with similar improvements in steps/day.
","['60 participants with T2D and suboptimal moderate to vigorous physical activity (MVPA; <150 minutes/week', 'Type 2 Diabetes', 'patients with type 2 diabetes (T2D']","['phone-delivered PP-MI intervention to an attention-matched MI-enhanced behavioral counseling condition', 'novel combined positive psychology-motivational interviewing (PP-MI) intervention', 'Positive Psychology-Motivational Interviewing Intervention']","['MVPA', 'feasibility (proportion of sessions completed) and acceptability (0-10 ease and utility ratings of each session', 'changes in positive affect (main psychological outcome) and accelerometer-measured physical activity (MVPA and steps/day']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0556975', 'cui_str': 'mins/week'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0033909', 'cui_str': 'Psychology'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C4546207', 'cui_str': 'Behavioral counseling'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1510628', 'cui_str': 'Positive Psychology'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",60.0,0.10928,"PP-MI participants also had greater improvements in MVPA (8 weeks: EMD 13.05 minutes/day [SE 5.00], p=.009, ES=1.24; 16 weeks: EMD 7.96 [SE 4.53], p=.079, ES=.75), with similar improvements in steps/day.
","[{'ForeName': 'Jeff C', 'Initials': 'JC', 'LastName': 'Huffman', 'Affiliation': 'From the Harvard Medical School (Huffman, Massey, Feig, Chung, Millstein, Brown, Healy, Wexler, Park, Celano); Departments of Psychiatry (Huffman, Golden, Massey, Feig, Chung, Millstein, Brown, Gianangelo, Park, Celano), Neurology (Healy), and Medicine (Endocrinology; Wexler), Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Golden', 'Affiliation': ''}, {'ForeName': 'Christina N', 'Initials': 'CN', 'LastName': 'Massey', 'Affiliation': ''}, {'ForeName': 'Emily H', 'Initials': 'EH', 'LastName': 'Feig', 'Affiliation': ''}, {'ForeName': 'Wei-Jean', 'Initials': 'WJ', 'LastName': 'Chung', 'Affiliation': ''}, {'ForeName': 'Rachel A', 'Initials': 'RA', 'LastName': 'Millstein', 'Affiliation': ''}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Brown', 'Affiliation': ''}, {'ForeName': 'Taylor', 'Initials': 'T', 'LastName': 'Gianangelo', 'Affiliation': ''}, {'ForeName': 'Brian C', 'Initials': 'BC', 'LastName': 'Healy', 'Affiliation': ''}, {'ForeName': 'Deborah J', 'Initials': 'DJ', 'LastName': 'Wexler', 'Affiliation': ''}, {'ForeName': 'Elyse R', 'Initials': 'ER', 'LastName': 'Park', 'Affiliation': ''}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Celano', 'Affiliation': ''}]",Psychosomatic medicine,['10.1097/PSY.0000000000000840']
1316,32664282,"Changes in Metabolites During an Oral Glucose Tolerance Test in Early and Mid-Pregnancy: Findings from the PEARLS Randomized, Controlled Lifestyle Trial.","The oral glucose tolerance test (OGTT) is used to diagnose gestational and other types of diabetes. We examined metabolite changes during an OGTT, and how a comprehensive diet and physical activity intervention may influence these changes in a population of overweight/obese Hispanic pregnant women. Integration of changes in metabolites during an OGTT may help us gain preliminary insights into how glucose metabolism changes during pregnancy. Among women from the Pregnancy and EARly Lifestyle improvement Study (PEARLS), we measured metabolites during a multipoint OGTT (fasting, 30, 60 and 120 min) at early and mid-pregnancy. Metabolite levels were measured by liquid chromatography-mass spectrometry in plasma samples in the lifestyle intervention ( n  = 13) and control ( n  = 16) arms of the study. A total of 65 candidate metabolites were selected that displayed changes during an OGTT in previous studies. Paired and unpaired  t -tests were used to examine differences in Δfast-120 min: (1) at early and mid-pregnancy; and (2) by intervention assignment. We applied principal component analysis (PCA) to identify those metabolites that differed by intervention assignment and OGTT time points. Most of the characteristic changes in metabolites post-OGTT were similar at both gestational time points. PCA identified characteristic metabolite patterns associated with OGTT time points at both early and mid-pregnancy. These metabolites included ketone bodies, tryptophan, acyl carnitines, polyunsaturated fatty acids, and biomarkers related to bile acid, urea cycle, arginine, and proline metabolism. PCA identified distinct Δfast-120 min in fatty acid, acyl carnitine, bile acid, ketone body, and amino acid levels at mid- compared to early pregnancy. Participants in the intervention group did not display mean decreases in Δfast-120 min of several long-chain acyl carnitines that were observed in the control group. These findings provide preliminary insight into metabolites, whose role in increased insulin resistance during pregnancy, should be explored further in future studies.",2020,Participants in the intervention group did not display mean decreases in Δfast-120 min of several long-chain acyl carnitines that were observed in the control group.,"['population of overweight/obese Hispanic pregnant women', 'Early and Mid-Pregnancy']",['comprehensive diet and physical activity intervention'],"['Metabolite levels', 'fatty acid, acyl carnitine, bile acid, ketone body, and amino acid levels', 'oral glucose tolerance test (OGTT']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0368608', 'cui_str': 'Acylcarnitine'}, {'cui': 'C0005390', 'cui_str': 'Bile acid'}, {'cui': 'C0022631', 'cui_str': 'Ketone body'}, {'cui': 'C1328436', 'cui_str': 'Amino acid level'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}]",,0.0276949,Participants in the intervention group did not display mean decreases in Δfast-120 min of several long-chain acyl carnitines that were observed in the control group.,"[{'ForeName': 'Danielle E', 'Initials': 'DE', 'LastName': 'Haslam', 'Affiliation': ""Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital, 75 Francis Street, Boston, MA 02115, USA.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Nutrition, Harvard T.H. Chan School of Public Health, 655 Huntington Ave, Boston, MA 02115, USA.'}, {'ForeName': 'Liming', 'Initials': 'L', 'LastName': 'Liang', 'Affiliation': 'Department of Epidemiology, Harvard T.H. Chan School of Public Health, 655 Huntington Ave, Boston, MA 02115, USA.'}, {'ForeName': 'Marijulie', 'Initials': 'M', 'LastName': 'Martinez', 'Affiliation': 'Center for Clinical Research and Health Promotion, University of Puerto Rico Medical Sciences Campus, San Juan, PR 00936-5067, Puerto Rico.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Palacios', 'Affiliation': 'Dietetics and Nutrition Department, Robert Stempel College of Public Health & Social Work, Florida International University, 11200 SW 8th Street AHC5, Miami, FL 33199, USA.'}, {'ForeName': 'Maria A', 'Initials': 'MA', 'LastName': 'Trak-Fellermeier', 'Affiliation': 'Dietetics and Nutrition Department, Robert Stempel College of Public Health & Social Work, Florida International University, 11200 SW 8th Street AHC5, Miami, FL 33199, USA.'}, {'ForeName': 'Paul W', 'Initials': 'PW', 'LastName': 'Franks', 'Affiliation': 'Lund University Diabetes Centre, CRC, SUS Malmö, Jan Waldenströms gata 35, House 91:12, SE-214 28 Malmö, Sweden.'}, {'ForeName': 'Kaumudi', 'Initials': 'K', 'LastName': 'Joshipura', 'Affiliation': 'Department of Epidemiology, Harvard T.H. Chan School of Public Health, 655 Huntington Ave, Boston, MA 02115, USA.'}, {'ForeName': 'Shilpa N', 'Initials': 'SN', 'LastName': 'Bhupathiraju', 'Affiliation': ""Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital, 75 Francis Street, Boston, MA 02115, USA.""}]",Metabolites,['10.3390/metabo10070284']
1317,32682347,A PERIOD3 variable number tandem repeat polymorphism modulates melatonin treatment response in delayed sleep-wake phase disorder.,"We examined whether a polymorphism of the PERIOD3 gene (PER3; rs57875989) modulated the sleep-promoting effects of melatonin in Delayed Sleep-Wake Phase Disorder (DSWPD). One hundred and four individuals (53 males; 29.4 ±10.0 years) with DSWPD and a delayed dim light melatonin onset (DLMO) collected buccal swabs for genotyping (PER3 4/4  n = 43; PER3 5 allele [heterozygous and homozygous] n = 60). Participants were randomised to placebo or 0.5 mg melatonin taken 1 hour before desired bedtime (or ~1.45 hours before DLMO), with sleep attempted at desired bedtime (4 weeks; 5-7 nights/week). We assessed sleep (diary and actigraphy), Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI), Patient-Reported Outcomes Measurement Information System (PROMIS: Sleep Disturbance, Sleep-Related Impairment), Sheehan Disability Scale (SDS) and Patient- and Clinician-Global Improvement (PGI-C, CGI-C). Melatonin treatment response on actigraphic sleep onset time did not differ between genotypes. For PER3 4/4  carriers, self-reported sleep onset time was advanced by a larger amount and sleep onset latency (SOL) was shorter in melatonin-treated patients compared to those receiving placebo (P = .008), while actigraphic sleep efficiency in the first third of the sleep episode (SE T1) did not differ. For PER3 5 carriers, actigraphic SOL and SE T1 showed a larger improvement with melatonin (P < .001). Melatonin improved ISI (P = .005), PROMIS sleep disturbance (P < .001) and sleep-related impairment (P = .017), SDS (P = .019), PGI-C (P = .028) and CGI-C (P = .016) in PER3 4/4  individuals only. Melatonin did not advance circadian phase. Overall, PER3 4/4  DSWPD patients have a greater response to melatonin treatment. PER3 genotyping may therefore improve DSWPD patient outcomes.",2020,"Melatonin improved ISI (P=0.005), PROMIS Sleep Disturbance (P<0.001) and Sleep-Related Impairment (P=0.017), SDS (P=0.019), PGI-C (P=0.028), and CGI-C (P=0.016) in PER3 4/4  individuals only.","['Delayed Sleep-Wake Phase Disorder', 'Delayed Sleep-Wake Phase Disorder (DSWPD', 'One hundred and four individuals (53 males; 29.4±10.0 years) with DSWPD and a delayed dim light melatonin onset (DLMO) collected buccal swabs for genotyping (PER3 4/4  n=43']","['placebo or 0.5mg melatonin', 'melatonin', 'Melatonin', 'placebo']","['sleep (diary and actigraphy), Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI), Patient-Reported Outcomes Measurement Information System (PROMIS: Sleep Disturbance, Sleep-Related Impairment), Sheehan Disability Scale (SDS), and Patient- and Clinician-Global Improvement (PGI-C, CGI-C', 'sleep onset latency (SOL', 'ISI', 'actigraphic sleep efficiency', 'Sleep-Related Impairment', 'PGI-C', 'actigraphic sleep onset time', 'PROMIS Sleep Disturbance']","[{'cui': 'C0393770', 'cui_str': 'Sleep-wake schedule disorder, delayed phase type'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0114346', 'cui_str': 'dimesna'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0581714', 'cui_str': 'Buccal smear procedure'}, {'cui': 'C0017337', 'cui_str': 'Gene'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0021428', 'cui_str': 'Information system'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C4720840', 'cui_str': 'Sheehan disability scale'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0523816', 'cui_str': 'Pepsinogen I measurement'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0205208', 'cui_str': 'Solid'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0449244', 'cui_str': 'Time of onset'}]",104.0,0.188696,"Melatonin improved ISI (P=0.005), PROMIS Sleep Disturbance (P<0.001) and Sleep-Related Impairment (P=0.017), SDS (P=0.019), PGI-C (P=0.028), and CGI-C (P=0.016) in PER3 4/4  individuals only.","[{'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Magee', 'Affiliation': 'Turner Institute for Brain and Mental Health, School of Psychological Sciences, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Tracey L', 'Initials': 'TL', 'LastName': 'Sletten', 'Affiliation': 'Turner Institute for Brain and Mental Health, School of Psychological Sciences, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Jade M', 'Initials': 'JM', 'LastName': 'Murray', 'Affiliation': 'Turner Institute for Brain and Mental Health, School of Psychological Sciences, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Gordon', 'Affiliation': 'Cooperative Research Centre for Alertness, Safety and Productivity, Clayton, Victoria, Australia.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Lovato', 'Affiliation': 'Cooperative Research Centre for Alertness, Safety and Productivity, Clayton, Victoria, Australia.'}, {'ForeName': 'Delwyn J', 'Initials': 'DJ', 'LastName': 'Bartlett', 'Affiliation': 'Cooperative Research Centre for Alertness, Safety and Productivity, Clayton, Victoria, Australia.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Kennaway', 'Affiliation': 'Robinson Research Institute, Adelaide School of Medicine, University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Steven W', 'Initials': 'SW', 'LastName': 'Lockley', 'Affiliation': 'Turner Institute for Brain and Mental Health, School of Psychological Sciences, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Leon C', 'Initials': 'LC', 'LastName': 'Lack', 'Affiliation': 'Adelaide Institute for Sleep Health: A Flinders Centre of Research Excellence, School of Medicine, Flinders University, Adelaide, South Australia, Australia.'}, {'ForeName': 'Ronald R', 'Initials': 'RR', 'LastName': 'Grunstein', 'Affiliation': 'Cooperative Research Centre for Alertness, Safety and Productivity, Clayton, Victoria, Australia.'}, {'ForeName': 'Simon N', 'Initials': 'SN', 'LastName': 'Archer', 'Affiliation': 'Surrey Sleep Research Centre, Faculty of Health and Medical Sciences, University of Surrey, Guildford, UK.'}, {'ForeName': 'Shantha M W', 'Initials': 'SMW', 'LastName': 'Rajaratnam', 'Affiliation': 'Turner Institute for Brain and Mental Health, School of Psychological Sciences, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of pineal research,['10.1111/jpi.12684']
1318,33065663,Taylor Spatial Frame or Reamed Intramedullary Nailing for Closed Fractures of the Tibial Shaft: A Randomized Controlled Trial.,"OBJECTIVES


To compare a modern ring fixator [Taylor Spatial Frame (TSF)] and reamed intramedullary nailing (IMN) for the treatment of closed tibial shaft fractures.
DESIGN


Randomized controlled trial.
SETTING


Two university hospitals.
PATIENTS


Patients between 18 and 70 years of age surgically treated for an acute tibial shaft fracture.
INTERVENTION


TSF (n = 31) versus a reamed intramedullary nail (n = 32). The patients were followed up for 2 years.
MAIN OUTCOME MEASUREMENTS


The physical component summary of Short Form 36 (SF-36) at 2 years was the primary outcome measure. Secondary outcomes included the other components of the SF-36, pain assessed by a visual analogue scale (VAS), complications, and resource consumption.
RESULTS


The mean age was 43 years (SD 14.0), and 42 (67%) were men. The physical component summary at 2 years was 52.4 (SD 6.3) in the TSF group and 53.3 (SD 8.0) in the IMN group (P = 0.35). There were modest differences in the other SF-36 scores during the follow-up period. Up to and including 12 months, the TSF group had less knee pain [at 12 months: VAS 0.5 (SD 1.2) vs. VAS 2.4 (SD 2.2; P < 0.001)], but this was not statistically significant at 24 months [VAS 0.7 (SD 1.4) vs. VAS 1.5 (SD 2.0; P = 0.11)]. Superficial skin infections were more frequent in the TSF group [22 (71%) vs. 4 (13%); P < 0.001]. The number of other complications was similar between the groups.
CONCLUSIONS


Both TSF and IMN provided good clinical results. TSF had more pin-track infections but less knee pain the first year.
LEVEL OF EVIDENCE


Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.",2020,Superficial skin infections were more frequent in the TSF group [22 (71%) vs. 4 (13%); P < 0.001].,"['Closed Fractures of the Tibial Shaft', 'Patients between 18 and 70 years of age surgically treated for an acute tibial shaft fracture', 'The mean age was 43 years (SD 14.0), and 42 (67%) were men', 'closed tibial shaft fractures', 'Two university hospitals']","['Taylor Spatial Frame or Reamed Intramedullary Nailing', 'reamed intramedullary nail', 'modern ring fixator [Taylor Spatial Frame (TSF', 'TSF', 'reamed intramedullary nailing (IMN']","['pin-track infections', 'other components of the SF-36, pain assessed by a visual analogue scale (VAS), complications, and resource consumption', 'number of other complications', 'knee pain', 'Superficial skin infections', 'SF-36 scores']","[{'cui': 'C0016659', 'cui_str': 'Fracture, closed'}, {'cui': 'C0588199', 'cui_str': 'Bone structure of shaft of tibia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0080089', 'cui_str': 'Reading Frames'}, {'cui': 'C2606415', 'cui_str': 'ZDHHC2 protein, human'}, {'cui': 'C0021885', 'cui_str': 'Bone nailing'}, {'cui': 'C0521164', 'cui_str': 'Annular shape'}, {'cui': 'C0441254', 'cui_str': 'Fixation device'}]","[{'cui': 'C0021885', 'cui_str': 'Bone nailing'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C0007642', 'cui_str': 'Cellulitis'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.112105,Superficial skin infections were more frequent in the TSF group [22 (71%) vs. 4 (13%); P < 0.001].,"[{'ForeName': 'Frede', 'Initials': 'F', 'LastName': 'Frihagen', 'Affiliation': 'Division of Orthopedic Surgery, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Jan E', 'Initials': 'JE', 'LastName': 'Madsen', 'Affiliation': 'Division of Orthopedic Surgery, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Sundfeldt', 'Affiliation': 'Orthopaedic Department, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Gunnar B', 'Initials': 'GB', 'LastName': 'Flugsrud', 'Affiliation': 'Division of Orthopedic Surgery, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Joakim S', 'Initials': 'JS', 'LastName': 'Andreassen', 'Affiliation': 'Division of Orthopedic Surgery, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Mette R', 'Initials': 'MR', 'LastName': 'Andersen', 'Affiliation': 'Department of Orthopaedic Surgery, Baerum Hospital, Vestre Viken Hospital Trust, Norway.'}, {'ForeName': 'Geir S', 'Initials': 'GS', 'LastName': 'Andreassen', 'Affiliation': 'Division of Orthopedic Surgery, Oslo University Hospital, Oslo, Norway.'}]",Journal of orthopaedic trauma,['10.1097/BOT.0000000000001802']
1319,33066130,"Designing an Effective Front-of-Package Warning Label for Food and Drinks High in Added Sugar, Sodium, or Saturated Fat in Colombia: An Online Experiment.","Policies to require warnings on the front of food and drinks high in nutrients of concern (e.g., added sugar, sodium, or saturated fat) are becoming increasingly common as an obesity prevention strategy. Colombia, a country with growing prevalence of obesity, is considering implementing a similar policy. The objective of this study was to assess perceptions and reactions to different warning designs. We conducted a randomized experiment in an online panel of adults age > 18y ( n  = 1997). Participants were randomized to view one of four labels: a control label (barcode), an octagon warning, a circle warning, and a triangle warning. Participants viewed their randomly assigned label on a series of products and answered questions (continuous outcomes ranged from 1-4). Compared to the control, all warnings led to higher perceived message effectiveness (increase in mean from 1.79 in the control to 2.59-2.65 in the warning conditions,  p  < 0.001), a higher percentage of participants who correctly identified products high in nutrients of concern (from 48% in the control condition to 84-89% in the warning conditions,  p  < 0.001), and reduced intentions to purchases these products (decrease in mean from 2.59 to 1.99-2.01 in the warning conditions,  p  < 0.001). Relative to the control, warnings performed similarly across education levels, suggesting this policy would be equitable in Colombia. Looking at differences by warning type, the pattern of results suggested that the octagon warnings performed best. After viewing all label types, 49% of participants selected the octagon warning as the one that most discouraged them from consuming products high in nutrients of concern, while 21% and 27% selected the circle and triangle warning. Colombian policymakers should consider the octagon warning as part of a front-of-package labeling policy to help consumers identify and reduce consumption of foods and drinks high in nutrients of concern.",2020,"Compared to the control, all warnings led to higher perceived message effectiveness (increase in mean from 1.79 in the control to 2.59-2.65 in the warning conditions,  p  < 0.001), a higher percentage of participants who correctly identified products high in nutrients of concern (from 48% in the control condition to 84-89% in the warning conditions,  p  < 0.001), and reduced intentions to purchases these products (decrease in mean from 2.59 to 1.99-2.01 in the warning conditions,  p  < 0.001).",['online panel of adults age '],"['control label (barcode), an octagon warning, a circle warning, and a triangle warning']",['message effectiveness'],"[{'cui': 'C0441833', 'cui_str': 'Groups'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0231706', 'cui_str': 'Circling gait'}, {'cui': 'C0205119', 'cui_str': 'Triangular'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.0350172,"Compared to the control, all warnings led to higher perceived message effectiveness (increase in mean from 1.79 in the control to 2.59-2.65 in the warning conditions,  p  < 0.001), a higher percentage of participants who correctly identified products high in nutrients of concern (from 48% in the control condition to 84-89% in the warning conditions,  p  < 0.001), and reduced intentions to purchases these products (decrease in mean from 2.59 to 1.99-2.01 in the warning conditions,  p  < 0.001).","[{'ForeName': 'Lindsey Smith', 'Initials': 'LS', 'LastName': 'Taillie', 'Affiliation': 'Carolina Population Center and Department of Nutrition, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC 27599, USA.'}, {'ForeName': 'Marissa G', 'Initials': 'MG', 'LastName': 'Hall', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, Lineberger Comprehensive Cancer Center, Carolina Population Center, University of North Carolina, Chapel Hill, NC 27599, USA.'}, {'ForeName': 'Luis Fernando', 'Initials': 'LF', 'LastName': 'Gómez', 'Affiliation': 'Facultad de Medicina, Pontificia Universidad Javeriana, 110231 Bogotá, Colombia.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Higgins', 'Affiliation': 'Carolina Population Center, University of North Carolina, Chapel Hill, NC 27516, USA.'}, {'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Bercholz', 'Affiliation': 'Carolina Population Center, University of North Carolina, Chapel Hill, NC 27516, USA.'}, {'ForeName': 'Nandita', 'Initials': 'N', 'LastName': 'Murukutla', 'Affiliation': 'Vital Strategies, New York, NY 27599, USA.'}, {'ForeName': 'Mercedes', 'Initials': 'M', 'LastName': 'Mora-Plazas', 'Affiliation': 'Departamento de Nutrición Humana, Universidad Nacional de Colombia, 11001 Bogotá, Colombia.'}]",Nutrients,['10.3390/nu12103124']
1320,33066213,Oxygenation before Endoscopic Sedation Reduces the Hypoxic Event during Endoscopy in Elderly Patients: A Randomized Controlled Trial.,"BACKGROUND


Sedation endoscopy increases patient and examiner satisfaction but involves complications. The most serious complication is hypoxia, the risk factors for which are old age, obesity, and American Society of Anesthesiologists physical status of 3 or greater. However, clear evidence of oxygenation during sedation endoscopy for elderly people is lacking in US, European, and Korean guidelines.
METHOD


This study was conducted for 1 year starting in August 2018 to evaluate whether pre-oxygenation use 1 min before sedation endoscopy could reduce the incidence of hypoxia in patients older than 65 years of age. A total of 70 patients were divided into the non-oxygenated group ( n  = 35; control group) and oxygen-treated group ( n  = 35; experimental group) during endoscopy.
RESULT


The incidence of hypoxia was 28 (80%) in the control group versus 0 (0%) in the pre-oxygenated group. Factors related to hypoxia in the non-oxygenated group were a relatively high dose of midazolam and concomitant injection with narcotic analgesics such as pethidine.
CONCLUSION


The incidence of hypoxia during sedation endoscopy is high in patients over 65 years, but oxygenation during endoscopic sedation in elderly people can significantly reduce the incidence of intraprocedural hypoxic events.",2020,The incidence of hypoxia was 28 (80%) in the control group versus 0 (0%) in the pre-oxygenated group.,"['70 patients', 'Elderly Patients', 'patients older than 65 years of age']","['oxygen-treated group ( n  = 35; experimental group) during endoscopy', 'pre-oxygenation use 1 min before sedation endoscopy', 'midazolam']",['incidence of hypoxia'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}]",70.0,0.0672732,The incidence of hypoxia was 28 (80%) in the control group versus 0 (0%) in the pre-oxygenated group.,"[{'ForeName': 'Hyunil', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Yonsei University Wonju College of Medicine, Ilsan-ro 20, Wonju 26426, Korea.'}, {'ForeName': 'Jeong Nam', 'Initials': 'JN', 'LastName': 'Hyun', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Yonsei University Wonju College of Medicine, Ilsan-ro 20, Wonju 26426, Korea.'}, {'ForeName': 'Kyong Joo', 'Initials': 'KJ', 'LastName': 'Lee', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Yonsei University Wonju College of Medicine, Ilsan-ro 20, Wonju 26426, Korea.'}, {'ForeName': 'Hyun-Soo', 'Initials': 'HS', 'LastName': 'Kim', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Yonsei University Wonju College of Medicine, Ilsan-ro 20, Wonju 26426, Korea.'}, {'ForeName': 'Hong Jun', 'Initials': 'HJ', 'LastName': 'Park', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Yonsei University Wonju College of Medicine, Ilsan-ro 20, Wonju 26426, Korea.'}]",Journal of clinical medicine,['10.3390/jcm9103282']
1321,33066237,"Efficacy and Patient Tolerability Profiles of Probiotic Solution with Bisacodyl Versus Conventional Cleansing Solution for Bowel Preparation: A Prospective, Randomized, Controlled Trial.","Although adequate bowel preparation is essential in screening colonoscopy, patient intolerability to bowel cleansing agents is problematic. Recently, a probiotic mixture solution with bisacodyl emerged to improve patient tolerability. We investigated the efficacy, safety, and patient tolerability profiles of probiotics with bisacodyl versus conventional polyethylene glycol (PEG) solution for bowel preparation for screening colonoscopies in healthy patients in this prospective, randomized, case-control study. In total, 385 volunteers were randomly assigned to receive 2 L of water + 200 mL of probiotic solution (case group,  n  = 195) or 4 L of PEG solution (control group,  n  = 190). The efficacy of the bowel cleansing was evaluated using the Ottawa scale system, polyp detection rate, and adenoma detection rate, and the patient tolerability profiles were assessed using a questionnaire. The demographics were not significantly different between groups. When the Ottawa score for each bowel segment was stratified into an adequate vs. inadequate level (Ottawa score ≤ 3 vs. >3), there were no statistical differences between groups in each segment of the colon. There were no significant differences in the polyp and adenoma detection rates between groups (38.42% vs. 32.42,  p  = 0.30; 25.79% vs. 18.97%,  p  = 0.11). The case group showed significantly fewer events than the control group, especially nausea, vomiting, and abdominal bloating events. Regarding the overall satisfaction grade, the case group reported significantly more ""average"" scores (95% vs. 44%,  p <  0.001) and were more willing to use the same agents again (90.26% vs. 61.85%,  p <  0.001). As patient compliance with bowel preparation agents is associated with an adequate level of bowel cleansing, a probiotic solution with bisacodyl might be a new bowel preparation candidate, especially in patients who show a poor compliance with conventional bowel preparation agents.",2020,"There were no significant differences in the polyp and adenoma detection rates between groups (38.42% vs. 32.42,  p  = 0.30; 25.79% vs. 18.97%,  p  = 0.11).","['patients who show a poor compliance with conventional bowel preparation agents', '385 volunteers', 'Bowel Preparation', 'healthy patients']","['Probiotic Solution with Bisacodyl Versus Conventional Cleansing Solution', '2 L of water + 200 mL of probiotic solution (case group,  n  = 195) or 4 L of PEG solution', 'probiotics with bisacodyl versus conventional polyethylene glycol (PEG) solution']","['patient tolerability', 'nausea, vomiting, and abdominal bloating events', 'Ottawa scale system, polyp detection rate, and adenoma detection rate, and the patient tolerability profiles', 'efficacy, safety, and patient tolerability profiles', 'polyp and adenoma detection rates', 'average"" scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0455052', 'cui_str': 'Preparation of bowel for procedure'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C4517751', 'cui_str': '385'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0005632', 'cui_str': 'Bisacodyl'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C0032483', 'cui_str': 'Polyethylene Glycols'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0000731', 'cui_str': 'Swollen abdomen'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0032584', 'cui_str': 'Polyp'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",385.0,0.0465274,"There were no significant differences in the polyp and adenoma detection rates between groups (38.42% vs. 32.42,  p  = 0.30; 25.79% vs. 18.97%,  p  = 0.11).","[{'ForeName': 'Youn I', 'Initials': 'YI', 'LastName': 'Choi', 'Affiliation': 'Gil Medical Center, Department of Gastroenterology, Gachon University College of Medicine, 405-760 1198 Guwol dong, Namdong-gu, Incheon 21565, Korea.'}, {'ForeName': 'Jong-Joon', 'Initials': 'JJ', 'LastName': 'Lee', 'Affiliation': 'Gil Medical Center, Department of Gastroenterology, Gachon University College of Medicine, 405-760 1198 Guwol dong, Namdong-gu, Incheon 21565, Korea.'}, {'ForeName': 'Jun-Won', 'Initials': 'JW', 'LastName': 'Chung', 'Affiliation': 'Gil Medical Center, Department of Gastroenterology, Gachon University College of Medicine, 405-760 1198 Guwol dong, Namdong-gu, Incheon 21565, Korea.'}, {'ForeName': 'Kyoung Oh', 'Initials': 'KO', 'LastName': 'Kim', 'Affiliation': 'Gil Medical Center, Department of Gastroenterology, Gachon University College of Medicine, 405-760 1198 Guwol dong, Namdong-gu, Incheon 21565, Korea.'}, {'ForeName': 'Yoon Jae', 'Initials': 'YJ', 'LastName': 'Kim', 'Affiliation': 'Gil Medical Center, Department of Gastroenterology, Gachon University College of Medicine, 405-760 1198 Guwol dong, Namdong-gu, Incheon 21565, Korea.'}, {'ForeName': 'Jung Ho', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Gil Medical Center, Department of Gastroenterology, Gachon University College of Medicine, 405-760 1198 Guwol dong, Namdong-gu, Incheon 21565, Korea.'}, {'ForeName': 'Dong Kyun', 'Initials': 'DK', 'LastName': 'Park', 'Affiliation': 'Gil Medical Center, Department of Gastroenterology, Gachon University College of Medicine, 405-760 1198 Guwol dong, Namdong-gu, Incheon 21565, Korea.'}, {'ForeName': 'Kwang An', 'Initials': 'KA', 'LastName': 'Kwon', 'Affiliation': 'Gil Medical Center, Department of Gastroenterology, Gachon University College of Medicine, 405-760 1198 Guwol dong, Namdong-gu, Incheon 21565, Korea.'}]",Journal of clinical medicine,['10.3390/jcm9103286']
1322,33066334,"A Randomized, Double-Blinded, Placebo-Controlled, Clinical Study of the Effects of a Nutraceutical Combination (LEVELIP DUO ® ) on LDL Cholesterol Levels and Lipid Pattern in Subjects with Sub-Optimal Blood Cholesterol Levels (NATCOL Study).","Phytosterols and red yeast rice are largely studied cholesterol-lowering nutraceuticals, respectively inhibiting the bowel absorption and liver synthesis of cholesterol. Our aim was to test the effect of combined nutraceutical-containing phytosterols and red yeast rice vs. a placebo on the lipid profile. We performed a parallel arms, double-blind, placebo-controlled clinical trial, randomizing 88 moderately hypercholesterolemic subjects to treatment with a combined nutraceutical containing phytosterols (800 mg) and red yeast rice, standardized to contain 5 mg of monacolins from  Monascus purpureus , with added niacin (27 mg) and policosanols (10 mg) (LEVELIP DUO ® ) ,  or placebo. The mean LDL-Cholesterol (LDL-C) change at Week 8 was -32.5 ± 30.2 mg/dL (-19.8%) in the combined nutraceutical group and 2.5 ± 19.4 mg/dL (2.3%) in the placebo group. The estimated between-group difference of -39.2 mg/dL (95% CI: -48.6; -29.8) indicates a statistically significant difference between treatments in favor of the combined nutraceutical ( p  < 0.0001). Total Cholesterol (TC), non-HDL cholesterol (non-HDL-C), Apolipoprotein B, TC/HDL-C and LDL-C/HDL-C improved in a similar way in the combined nutraceutical group only. No significant changes in other clinical and laboratory parameters were observed. In conclusion, the tested combined nutraceutical was well tolerated, while significantly reducing the plasma levels of LDL-C, TC, non-HDL-C, ApoB, TC/HDL-C and LDL-C/HDL-C ratios in mildly hypercholesterolemic patients. Trial registration (ClinicalTrials.gov): NCT03739242.",2020,"Apolipoprotein B, TC/HDL-C and LDL-C/HDL-C improved in a similar way in the combined nutraceutical group only.","['mildly hypercholesterolemic patients', 'Subjects with Sub-Optimal Blood Cholesterol Levels (NATCOL Study', '88 moderately hypercholesterolemic subjects']","['Nutraceutical Combination (LEVELIP DUO ® ', 'combined nutraceutical containing phytosterols (800 mg) and red yeast rice, standardized to contain 5 mg of monacolins from  Monascus purpureus , with added niacin (27 mg) and policosanols (10 mg) (LEVELIP DUO ® ) ,  or placebo', 'combined nutraceutical-containing phytosterols and red yeast rice vs. a placebo', 'placebo', 'Placebo']","['plasma levels of LDL-C, TC, non-HDL-C, ApoB, TC/HDL-C and LDL-C/HDL-C ratios', 'Total Cholesterol (TC), non-HDL cholesterol (non-HDL-C', 'lipid profile', 'Apolipoprotein B, TC/HDL-C and LDL-C/HDL-C', 'mean LDL-Cholesterol (LDL-C) change', 'LDL Cholesterol Levels and Lipid Pattern']","[{'cui': 'C2945599', 'cui_str': 'Mild'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0518017', 'cui_str': 'Blood cholesterol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}]","[{'cui': 'C1518478', 'cui_str': 'Nutriceuticals'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0031866', 'cui_str': 'Phytosterols'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0763533', 'cui_str': 'red yeast rice'}, {'cui': 'C0997449', 'cui_str': 'Monascus purpureus'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0027996', 'cui_str': 'Niacin'}, {'cui': 'C0215278', 'cui_str': 'policosanol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0003593', 'cui_str': 'Apolipoprotein B'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0729627', 'cui_str': 'Non-HDL cholesterol'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}]",88.0,0.389198,"Apolipoprotein B, TC/HDL-C and LDL-C/HDL-C improved in a similar way in the combined nutraceutical group only.","[{'ForeName': 'Arrigo F G', 'Initials': 'AFG', 'LastName': 'Cicero', 'Affiliation': 'Medical an Surgery Sciences Department, Dyslipidemia and Atherosclerosis Research Unit, Alma Mater Studiorum University of Bologna, 40138 Bologna, Italy.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': ""D'Addato"", 'Affiliation': 'Medical an Surgery Sciences Department, Dyslipidemia and Atherosclerosis Research Unit, Alma Mater Studiorum University of Bologna, 40138 Bologna, Italy.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Borghi', 'Affiliation': 'Medical an Surgery Sciences Department, Dyslipidemia and Atherosclerosis Research Unit, Alma Mater Studiorum University of Bologna, 40138 Bologna, Italy.'}]",Nutrients,['10.3390/nu12103127']
1323,32669641,Usefulness of three-dimensional printing of superior mesenteric vessels in right hemicolon cancer surgery.,"The anatomy of the superior mesenteric vessels is complex, yet important, for right-sided colorectal surgery. The usefulness of three-dimensional (3D) printing of these vessels in right hemicolon cancer surgery has rarely been reported. In this prospective clinical study, 61 patients who received laparoscopic surgery for right hemicolon cancer were preoperatively randomized into 3 groups: 3D-printing (20 patients), 3D-image (19 patients), and control (22 patients) groups. Surgery duration, bleeding volume, and number of lymph node dissections were designed to be the primary end points, whereas postoperative complications, post-operative flatus recovery time, duration of hospitalization, patient satisfaction, and medical expenses were designed to be secondary end points. To reduce the influence of including different surgeons in the study, the surgical team was divided into 2 groups based on surgical experience. The duration of surgery for the 3D-printing and 3D-image groups was significantly reduced (138.4 ± 19.5 and 154.7 ± 25.9 min vs. 177.6 ± 24.4 min, P = 0.000 and P = 0.006), while the number of lymph node dissections for the these 2 groups was significantly increased (19.1 ± 3.8 and 17.6 ± 3.9 vs. 15.8 ± 3.0, P = 0.001 and P = 0.024) compared to the control group. Meanwhile, the bleeding volume for the 3D-printing group was significantly reduced compared to the control group (75.8 ± 30.4 mL vs. 120.9 ± 39.1 mL, P = 0.000). Moreover, patients in the 3D-printing group reported increased satisfaction in terms of effective communication compared to those in the 3D-image and control groups. Medical expenses decreased by 6.74% after the use of 3D-printing technology. Our results show that 3D-printing technology could reduce the duration of surgery and total bleeding volume and increase the number of lymph node dissections. 3D-printing technology may be more helpful for novice surgeons.Trial registration: Chinese Clinical Trial Registry, ChiCTR1800017161. Registered on 15 July 2018.",2020,Our results show that 3D-printing technology could reduce the duration of surgery and total bleeding volume and increase the number of lymph node dissections.,"['61 patients who received', 'right hemicolon cancer surgery', 'for right hemicolon cancer']",['laparoscopic surgery'],"['effective communication', 'Medical expenses', 'number of lymph node dissections', 'satisfaction', 'duration of surgery', 'duration of surgery and total bleeding volume', 'bleeding volume', 'postoperative complications, post-operative flatus recovery time, duration of hospitalization, patient satisfaction, and medical expenses', 'Surgery duration, bleeding volume, and number of lymph node dissections']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1305188', 'cui_str': 'Right colon structure'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0024203', 'cui_str': 'Excision of lymph node'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}]",61.0,0.0319269,Our results show that 3D-printing technology could reduce the duration of surgery and total bleeding volume and increase the number of lymph node dissections.,"[{'ForeName': 'Yigang', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': ""Department of General Surgery, The Affiliated Wuxi No. 2 People's Hospital of Nanjing Medical University, 68 Zhongshan Road, Wuxi, 214002, Jiangsu, People's Republic of China.""}, {'ForeName': 'Linjie', 'Initials': 'L', 'LastName': 'Bian', 'Affiliation': ""Department of Radiology, The Affiliated Wuxi No. 2 People's Hospital of Nanjing Medical University, Wuxi, 214002, People's Republic of China.""}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': ""Department of General Surgery, The Affiliated Wuxi No. 2 People's Hospital of Nanjing Medical University, 68 Zhongshan Road, Wuxi, 214002, Jiangsu, People's Republic of China.""}, {'ForeName': 'Danping', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': ""Department of Radiology, The Affiliated Wuxi No. 2 People's Hospital of Nanjing Medical University, Wuxi, 214002, People's Republic of China.""}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': ""Operating Room, The Affiliated Wuxi No. 2 People's Hospital of Nanjing Medical University, Wuxi, 214002, People's Republic of China.""}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Gu', 'Affiliation': ""Department of General Surgery, The Affiliated Wuxi No. 2 People's Hospital of Nanjing Medical University, 68 Zhongshan Road, Wuxi, 214002, Jiangsu, People's Republic of China.""}, {'ForeName': 'Xinqi', 'Initials': 'X', 'LastName': 'Fan', 'Affiliation': ""Department of General Surgery, The Affiliated Wuxi No. 2 People's Hospital of Nanjing Medical University, 68 Zhongshan Road, Wuxi, 214002, Jiangsu, People's Republic of China.""}, {'ForeName': 'Zhequn', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': ""Harbin JunYang Technology Co., Ltd, Harbin, 150000, People's Republic of China.""}, {'ForeName': 'Junyi', 'Initials': 'J', 'LastName': 'Zou', 'Affiliation': ""Operating Room, The Affiliated Wuxi No. 2 People's Hospital of Nanjing Medical University, Wuxi, 214002, People's Republic of China.""}, {'ForeName': 'Jiazeng', 'Initials': 'J', 'LastName': 'Xia', 'Affiliation': ""Department of General Surgery, The Affiliated Wuxi No. 2 People's Hospital of Nanjing Medical University, 68 Zhongshan Road, Wuxi, 214002, Jiangsu, People's Republic of China. xjz_wuxi@alumni.sjtu.edu.cn.""}, {'ForeName': 'Zekuan', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': ""Department of General Surgery, First Affiliated Hospital of Nanjing Medical University, 140 Hanzhong Road, Nanjing, 210029, People's Republic of China. xuzekuan@njmu.edu.cn.""}]",Scientific reports,['10.1038/s41598-020-68578-y']
1324,32676780,"Combined use of tranexamic acid and rivaroxaban in posterior lumbar interbody fusion safely reduces blood loss and transfusion rates without increasing the risk of thrombosis-a prospective, stratified, randomized, controlled trial.","PURPOSE


This prospective, stratified, randomized, single-blind, placebo-controlled multicentre study investigated the safety and effectiveness of reducing blood loss and preventing venous thromboembolism (VTE) during posterior lumbar interbody fusion (PLIF) in patients with stenosis or spondylolisthesis using the combination of tranexamic acid (TXA) and rivaroxaban.
METHODS


The Autar score was evaluated in patients after admission. Patients with an Autar score ≤ 10 were randomized to group A or B. Group A was the placebo-controlled group. Patients in group B were treated with 1 g TXA via intravenous injection and 1 g TXA for external use. Patients with an Autar score > 10 were randomized to group C or D. Patients in group C were treated with 10-mg rivaroxaban qd for 35 days after surgery. Patients in group D received the same treatment as those in group B intra-operatively and as those in group C post-operatively.
RESULTS


A total of 599 patients from eight hospitals participated in this clinical trial. The total blood loss, intra-operative blood loss, and drainage volume were reduced by the administration of TXA (group A vs group B, P < 0.01; group C vs group D, P < 0.01), and the blood transfusion rate was also decreased (group A vs group B, P < 0.01; group C vs group D, P < 0.01). There were no significant differences (P > 0.05) in the VTE incidence rates among group A and group B. In patients with high-risk thrombosis, the number of patients with VTE was only three and seven after the application of rivaroxaban. Epidural haematoma was not discovered in any patients in our trial.
CONCLUSION


The combined application of tranexamic acid and rivaroxaban significantly reduced the amount of blood loss and the transfusion rate during PLIF surgery and avoided an increase in the probability of thrombosis and the occurrence of epidural haematoma.
TRIAL REGISTRATION NUMBER AND DATE OF REGISTRATION


ChiCTR-1800016430 2018-06-01.",2020,"The combined application of tranexamic acid and rivaroxaban significantly reduced the amount of blood loss and the transfusion rate during PLIF surgery and avoided an increase in the probability of thrombosis and the occurrence of epidural haematoma.
","['Patients with an Autar score\u2009>\u200910', '599 patients from eight hospitals participated in this clinical trial', 'Patients with an Autar score\u2009≤\u200910', 'patients with high-risk thrombosis', 'patients with stenosis or spondylolisthesis using the combination of']","['tranexamic acid and rivaroxaban', 'TXA', 'posterior lumbar interbody fusion (PLIF', 'tranexamic acid (TXA) and rivaroxaban', '10-mg rivaroxaban', 'rivaroxaban', 'TXA via intravenous injection and 1\xa0g TXA', 'placebo']","['VTE incidence rates', 'blood loss and preventing venous thromboembolism (VTE', 'blood transfusion rate', 'Epidural haematoma', 'probability of thrombosis', 'blood loss and transfusion rates', 'total blood loss, intra-operative blood loss, and drainage volume', 'blood loss and the transfusion rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}, {'cui': 'C0038016', 'cui_str': 'Spondylolisthesis'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0021494', 'cui_str': 'Intravenous injection'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0238154', 'cui_str': 'Epidural hemorrhage'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0232100', 'cui_str': 'Exsanguination'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",599.0,0.107914,"The combined application of tranexamic acid and rivaroxaban significantly reduced the amount of blood loss and the transfusion rate during PLIF surgery and avoided an increase in the probability of thrombosis and the occurrence of epidural haematoma.
","[{'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Spine Surgery, Qilu Hospital, Shandong University, 107, West Culture Road, Lixia District, Jinan, China.'}, {'ForeName': 'Yanming', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Spine Surgery, Affiliated Hospital of Jining Medical University, 89 Guhuai Road, Jining, China.'}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Liu', 'Affiliation': 'Department of Spine Surgery, Binzhou Medical University Hospital, 661 Huanghe 2nd Road, Binzhou, China.'}, {'ForeName': 'Xing', 'Initials': 'X', 'LastName': 'Xiao', 'Affiliation': 'Department of Spine Surgery, Shandong Provincial Qianfoshan Hospital, 16766 Jingshi Road, Jinan, China.'}, {'ForeName': 'Tingjin', 'Initials': 'T', 'LastName': 'Guan', 'Affiliation': 'Department of Spine Surgery, The First Hospital of Zibo City, 4, East Emeishan Road, Boshan District, Zibo, China.'}, {'ForeName': 'Hongwei', 'Initials': 'H', 'LastName': 'Yue', 'Affiliation': ""Department of Spine Surgery, Dezhou People's Hospital, 1166, Dongfanghong West Road, Decheng District, Dezhou, China.""}, {'ForeName': 'Haipeng', 'Initials': 'H', 'LastName': 'Xue', 'Affiliation': 'Department of Spine Surgery, Shandong Provincial Hospital of Traditional Chinese Medicine, 16369 Jingshi Road, Jinan, China.'}, {'ForeName': 'Hongming', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': 'Department of Spine Surgery, Linyi Central Hospital, 17, Jiankang Road, Yishui County, Linyi, China.'}, {'ForeName': 'Guangjun', 'Initials': 'G', 'LastName': 'Jiao', 'Affiliation': 'Department of Spine Surgery, Qilu Hospital, Shandong University, 107, West Culture Road, Lixia District, Jinan, China.'}, {'ForeName': 'Wenliang', 'Initials': 'W', 'LastName': 'Wu', 'Affiliation': 'Department of Spine Surgery, Qilu Hospital, Shandong University, 107, West Culture Road, Lixia District, Jinan, China.'}, {'ForeName': 'Hongliang', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Spine Surgery, Qilu Hospital, Shandong University, 107, West Culture Road, Lixia District, Jinan, China.'}, {'ForeName': 'Haichun', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of Spine Surgery, Qilu Hospital, Shandong University, 107, West Culture Road, Lixia District, Jinan, China.'}, {'ForeName': 'Chunyang', 'Initials': 'C', 'LastName': 'Meng', 'Affiliation': 'Department of Spine Surgery, Affiliated Hospital of Jining Medical University, 89 Guhuai Road, Jining, China.'}, {'ForeName': 'Zhaozhong', 'Initials': 'Z', 'LastName': 'Sun', 'Affiliation': 'Department of Spine Surgery, Binzhou Medical University Hospital, 661 Huanghe 2nd Road, Binzhou, China.'}, {'ForeName': 'Yunzhen', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Spine Surgery, Qilu Hospital, Shandong University, 107, West Culture Road, Lixia District, Jinan, China. qilucyz@yeah.net.'}]",International orthopaedics,['10.1007/s00264-020-04699-3']
1325,32678285,Cerebellar transcranial direct current stimulation for learning a novel split-belt treadmill task: a randomised controlled trial.,"This study aimed to examine the effect of repeated anodal cerebellar transcranial direct current stimulation (ctDCS) on learning a split-belt treadmill task. Thirty healthy individuals randomly received three consecutive sessions of active or sham anodal ctDCS during split-belt treadmill training. Motor performance and strides to steady-state performance were evaluated before (baseline), during (adaptation), and after (de-adaptation) the intervention. The outcomes were measured one week later to assess absolute learning and during the intervention to evaluate cumulative, consecutive, and session-specific effects. Data were analysed using linear mixed-effects regression models. During adaptation, there was no significant difference in absolute learning between the groups (p > 0.05). During de-adaptation, a significant difference in absolute learning between the groups (p = 0.03) indicated slower de-adaptation with anodal ctDCS. Pre-planned secondary analysis revealed that anodal ctDCS significantly reduced the cumulative (p = 0.01) and consecutive-session effect (p = 0.01) on immediate adaptation. There were significant cumulative (p = 0.02) and session-specific effects (p = 0.003) on immediate de-adaptation. Repeated anodal ctDCS does not enhance motor learning measured during adaptation to a split-belt treadmill task. However, it influences the maintenance of learnt walking patterns, suggesting that it may be beneficial in maintaining therapeutic effects.",2020,There were significant cumulative (p = 0.02) and session-specific effects (p = 0.003) on immediate de-adaptation.,['Thirty healthy individuals'],"['active or sham anodal ctDCS during split-belt treadmill training', 'anodal cerebellar transcranial direct current stimulation (ctDCS', 'Cerebellar transcranial direct current stimulation', 'anodal ctDCS']","['Motor performance and strides to steady-state performance', 'motor learning', 'absolute learning', 'session-specific effects']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0007765', 'cui_str': 'Cerebellar structure'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0452227', 'cui_str': 'Belt'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",30.0,0.0490166,There were significant cumulative (p = 0.02) and session-specific effects (p = 0.003) on immediate de-adaptation.,"[{'ForeName': 'Nitika', 'Initials': 'N', 'LastName': 'Kumari', 'Affiliation': 'Health and Rehabilitation Research Institute, Auckland University of Technology, Auckland, New Zealand. nitika.kumari@aut.ac.nz.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Taylor', 'Affiliation': 'Health and Rehabilitation Research Institute, Auckland University of Technology, Auckland, New Zealand.'}, {'ForeName': 'Usman', 'Initials': 'U', 'LastName': 'Rashid', 'Affiliation': 'Health and Rehabilitation Research Institute, Auckland University of Technology, Auckland, New Zealand.'}, {'ForeName': 'Alain C', 'Initials': 'AC', 'LastName': 'Vandal', 'Affiliation': 'Department of Statistics, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Paul F', 'Initials': 'PF', 'LastName': 'Smith', 'Affiliation': 'Department of Pharmacology and Toxicology, School of Biomedical Sciences, Brain Health Research Centre, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Nada', 'Initials': 'N', 'LastName': 'Signal', 'Affiliation': 'Health and Rehabilitation Research Institute, Auckland University of Technology, Auckland, New Zealand.'}]",Scientific reports,['10.1038/s41598-020-68825-2']
1326,32673060,Hydroxychloroquine in Nonhospitalized Adults With Early COVID-19 : A Randomized Trial.,"BACKGROUND


No effective oral therapy exists for early coronavirus disease 2019 (COVID-19).
OBJECTIVE


To investigate whether hydroxychloroquine could reduce COVID-19 severity in adult outpatients.
DESIGN


Randomized, double-blind, placebo-controlled trial conducted from 22 March through 20 May 2020. (ClinicalTrials.gov: NCT04308668).
SETTING


Internet-based trial across the United States and Canada (40 states and 3 provinces).
PARTICIPANTS


Symptomatic, nonhospitalized adults with laboratory-confirmed COVID-19 or probable COVID-19 and high-risk exposure within 4 days of symptom onset.
INTERVENTION


Oral hydroxychloroquine (800 mg once, followed by 600 mg in 6 to 8 hours, then 600 mg daily for 4 more days) or masked placebo.
MEASUREMENTS


Symptoms and severity at baseline and then at days 3, 5, 10, and 14 using a 10-point visual analogue scale. The primary end point was change in overall symptom severity over 14 days.
RESULTS


Of 491 patients randomly assigned to a group, 423 contributed primary end point data. Of these, 341 (81%) had laboratory-confirmed infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or epidemiologically linked exposure to a person with laboratory-confirmed infection; 56% (236 of 423) were enrolled within 1 day of symptoms starting. Change in symptom severity over 14 days did not differ between the hydroxychloroquine and placebo groups (difference in symptom severity: relative, 12%; absolute, -0.27 point [95% CI, -0.61 to 0.07 point];  P  = 0.117). At 14 days, 24% (49 of 201) of participants receiving hydroxychloroquine had ongoing symptoms compared with 30% (59 of 194) receiving placebo ( P  = 0.21). Medication adverse effects occurred in 43% (92 of 212) of participants receiving hydroxychloroquine versus 22% (46 of 211) receiving placebo ( P  < 0.001). With placebo, 10 hospitalizations occurred (2 non-COVID-19-related), including 1 hospitalized death. With hydroxychloroquine, 4 hospitalizations occurred plus 1 nonhospitalized death ( P  = 0.29).
LIMITATION


Only 58% of participants received SARS-CoV-2 testing because of severe U.S. testing shortages.
CONCLUSION


Hydroxychloroquine did not substantially reduce symptom severity in outpatients with early, mild COVID-19.
PRIMARY FUNDING SOURCE


Private donors.",2020,"With hydroxychloroquine, 4 hospitalizations occurred plus 1 nonhospitalized death ( P  = 0.29).
","['outpatients with early, mild COVID-19', 'Nonhospitalized Adults', '22 March through 20 May 2020', '341 (81%) had laboratory-confirmed infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or epidemiologically linked exposure to a person with laboratory-confirmed infection; 56% (236 of 423) were enrolled within 1 day of symptoms starting', 'Internet-based trial across the United States and Canada', 'Symptomatic, nonhospitalized adults with laboratory-confirmed COVID-19 or probable COVID-19 and high-risk exposure within 4 days of symptom onset', 'adult outpatients', '491 patients randomly assigned to a group, 423 contributed primary end point data']","['hydroxychloroquine', 'Hydroxychloroquine', 'Early COVID-19', 'Oral hydroxychloroquine', 'placebo']","['ongoing symptoms', 'overall symptom severity', '10-point visual analogue scale', 'Medication adverse effects', 'symptom severity', 'hospitalized death', 'Change in symptom severity', 'COVID-19 severity']","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0444930', 'cui_str': 'End'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",423.0,0.761778,"With hydroxychloroquine, 4 hospitalizations occurred plus 1 nonhospitalized death ( P  = 0.29).
","[{'ForeName': 'Caleb P', 'Initials': 'CP', 'LastName': 'Skipper', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).'}, {'ForeName': 'Katelyn A', 'Initials': 'KA', 'LastName': 'Pastick', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).'}, {'ForeName': 'Nicole W', 'Initials': 'NW', 'LastName': 'Engen', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).'}, {'ForeName': 'Ananta S', 'Initials': 'AS', 'LastName': 'Bangdiwala', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).'}, {'ForeName': 'Mahsa', 'Initials': 'M', 'LastName': 'Abassi', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).'}, {'ForeName': 'Sarah M', 'Initials': 'SM', 'LastName': 'Lofgren', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).'}, {'ForeName': 'Darlisha A', 'Initials': 'DA', 'LastName': 'Williams', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).'}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Okafor', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).'}, {'ForeName': 'Matthew F', 'Initials': 'MF', 'LastName': 'Pullen', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).'}, {'ForeName': 'Melanie R', 'Initials': 'MR', 'LastName': 'Nicol', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).'}, {'ForeName': 'Alanna A', 'Initials': 'AA', 'LastName': 'Nascene', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).'}, {'ForeName': 'Kathy H', 'Initials': 'KH', 'LastName': 'Hullsiek', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Cheng', 'Affiliation': 'Research Institute of the McGill University Health Centre and McGill University, Montréal, Quebec, Canada (M.P.C., E.G.M., T.C.L.).'}, {'ForeName': 'Darlette', 'Initials': 'D', 'LastName': 'Luke', 'Affiliation': 'M Health Fairview Investigational Drug Service Pharmacy, Minneapolis, Minnesota (D.L.).'}, {'ForeName': 'Sylvain A', 'Initials': 'SA', 'LastName': 'Lother', 'Affiliation': 'University of Manitoba, Winnipeg, Manitoba, Canada (S.A.L., L.J.M., G.D., R.Z.).'}, {'ForeName': 'Lauren J', 'Initials': 'LJ', 'LastName': 'MacKenzie', 'Affiliation': 'University of Manitoba, Winnipeg, Manitoba, Canada (S.A.L., L.J.M., G.D., R.Z.).'}, {'ForeName': 'Glen', 'Initials': 'G', 'LastName': 'Drobot', 'Affiliation': 'University of Manitoba, Winnipeg, Manitoba, Canada (S.A.L., L.J.M., G.D., R.Z.).'}, {'ForeName': 'Lauren E', 'Initials': 'LE', 'LastName': 'Kelly', 'Affiliation': 'George & Fay Yee Centre for Healthcare Innovation, Winnipeg, Manitoba, Canada (L.E.K.).'}, {'ForeName': 'Ilan S', 'Initials': 'IS', 'LastName': 'Schwartz', 'Affiliation': 'University of Alberta, Edmonton, Alberta, Canada (I.S.S.).'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Zarychanski', 'Affiliation': 'University of Manitoba, Winnipeg, Manitoba, Canada (S.A.L., L.J.M., G.D., R.Z.).'}, {'ForeName': 'Emily G', 'Initials': 'EG', 'LastName': 'McDonald', 'Affiliation': 'Research Institute of the McGill University Health Centre and McGill University, Montréal, Quebec, Canada (M.P.C., E.G.M., T.C.L.).'}, {'ForeName': 'Todd C', 'Initials': 'TC', 'LastName': 'Lee', 'Affiliation': 'Research Institute of the McGill University Health Centre and McGill University, Montréal, Quebec, Canada (M.P.C., E.G.M., T.C.L.).'}, {'ForeName': 'Radha', 'Initials': 'R', 'LastName': 'Rajasingham', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Boulware', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).'}]",Annals of internal medicine,['10.7326/M20-4207']
1327,32680841,A Swedish primary healthcare prevention programme focusing on promotion of physical activity and a healthy lifestyle reduced cardiovascular events and mortality: 22-year follow-up of 5761 study participants and a reference group.,"OBJECTIVE


To evaluate long-term risk of first cardiovascular (CV) events, CV deaths and all-cause deaths in community-dwelling participants of a cardiovascular disease (CVD) prevention programme delivered in a primary care setting.
METHODS


Individuals who visited a primary healthcare service in Sollentuna (Sweden) and agreed to participate in the programme between 1988 and 1993 were followed. They had at least one CV risk factor but no prior myocardial infarction and received support to increase physical activity using the programme Physical Activity on Prescription and to adopt health-promoting behaviours including cooking classes, weight reduction, smoking cessation and stress management. Participants (n=5761) were compared with a randomly selected, propensity score-matched reference group from the general population in Stockholm County (n=34 556). All individuals were followed in Swedish registers until December 2011.
RESULTS


In the intervention group and the reference group there were 698 (12.1%) and 4647 (13.4%) first CV events, 308 (5.3%) and 2261 (6.5%) CV deaths, and 919 (16.5%) and 6405 (18.5%) all-cause deaths, respectively, during a mean follow-up of 22 years. The HR (95% CI) in the intervention group compared with the reference group was 0.88 (0.81 to 0.95) for first CV events, 0.79 (0.70 to 0.89) for CV deaths and 0.83 (0.78 to 0.89) for all-cause deaths.
CONCLUSIONS


Participation in a CVD prevention programme in primary healthcare focusing on promotion of physical activity and healthy lifestyle was associated with lower risk of CV events (12%), CV deaths (21%) and all-cause deaths (17%) after two decades. Promoting physical activity and healthy living in the primary healthcare setting may prevent CVD.",2020,"They had at least one CV risk factor but no prior myocardial infarction and received support to increase physical activity using the programme Physical Activity on Prescription and to adopt health-promoting behaviours including cooking classes, weight reduction, smoking cessation and stress management.","['Participants (n=5761) were compared with a randomly selected, propensity score-matched reference group from the general population in Stockholm County (n=34 556', 'All individuals were followed in Swedish registers until December 2011', 'community-dwelling participants of a cardiovascular disease (CVD) prevention programme delivered in a primary care setting', 'Individuals who visited a primary healthcare service in Sollentuna (Sweden) and agreed to participate in the programme between 1988 and 1993 were followed', '5761 study participants and a reference group']",[],"['risk of CV events', 'cardiovascular events and mortality', 'CV deaths']","[{'cui': 'C2718044', 'cui_str': 'Propensity Score'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C4517811', 'cui_str': '556'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0038996', 'cui_str': 'Swedish language'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",5761.0,0.0433087,"They had at least one CV risk factor but no prior myocardial infarction and received support to increase physical activity using the programme Physical Activity on Prescription and to adopt health-promoting behaviours including cooking classes, weight reduction, smoking cessation and stress management.","[{'ForeName': 'Gunilla', 'Initials': 'G', 'LastName': 'Journath', 'Affiliation': 'Unit of Cardiology, Department of Medicine, Karolinska Institutet, Stockholm, Sweden gunilla.journath@ki.se.'}, {'ForeName': 'Niklas', 'Initials': 'N', 'LastName': 'Hammar', 'Affiliation': 'Unit of Epidemiology, Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Vikström', 'Affiliation': 'Unit of Cardiovascular and Nutritional Epidemiology, Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Anette', 'Initials': 'A', 'LastName': 'Linnersjö', 'Affiliation': 'Unit of Occupational Medicine, Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Göran', 'Initials': 'G', 'LastName': 'Walldius', 'Affiliation': 'Unit of Epidemiology, Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Ingvar', 'Initials': 'I', 'LastName': 'Krakau', 'Affiliation': 'Unit of Clinical Epidemiology, Department of Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lindgren', 'Affiliation': 'Medical Management Center, Department of Learning, Information, Management and Ethics, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'de Faire', 'Affiliation': 'Unit of Cardiovascular and Nutritional Epidemiology, Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Mai-Lis', 'Initials': 'ML', 'LastName': 'Hellenius', 'Affiliation': 'Unit of Cardiology, Department of Medicine, Karolinska Institutet, Stockholm, Sweden.'}]",British journal of sports medicine,['10.1136/bjsports-2019-101749']
1328,33065955,"Safety of IncobotulinumtoxinA in the Treatment of Facial Lines: Results From a Pooled Analysis of Randomized, Prospective, Controlled Clinical Studies.","BACKGROUND


The safety and efficacy of incobotulinumtoxinA in aesthetics has been established in multiple studies. Although individual studies have been reported, a combined assessment of incobotulinumtoxinA safety across studies is not available.
OBJECTIVE


To assess the frequency of adverse events (AEs) across prospective incobotulinumtoxinA studies in aesthetics.
MATERIALS AND METHODS


Safety data were assessed from 9 placebo-controlled or active-controlled single-dose studies on glabellar frown lines (GFL), crow's feet (CF), and upper facial lines (UFL). Analyses by treatment cycle included 4 repeat-dose studies on GFL and UFL.
RESULTS


One thousand three hundred seventy-seven subjects received incobotulinumtoxinA (GFL, n = 1,189; CF, n = 83; UFL, n = 105) in single-dose studies (placebo-controlled studies: incobotulinumtoxinA, n = 866; placebo, n = 395). Over 1,000 subjects received incobotulinumtoxinA in repeat-dose studies (GFL, n = 880; UFL, n = 290). In placebo-controlled single-dose studies, incidences of treatment-related AEs ranged from 5.4% (GFL) to 22.9% (UFL). The most frequent treatment-related AE in single-dose studies was headache (GFL, 4.8%; UFL, 11.4%). In repeat-dose studies, incidence of AEs was highest during cycle 1 (GFL, 8.9%; UFL, 17.2%) and decreased across treatment cycles. No serious treatment-related AEs were observed.
CONCLUSION


Results confirm the favorable safety and tolerability of incobotulinumtoxinA. The frequency of treatment-related AEs was low and may decrease with subsequent treatments.",2017,"No serious treatment-related AEs were observed.
","['One thousand three hundred seventy-seven subjects received', 'Facial Lines']","['incobotulinumtoxinA', 'placebo', 'IncobotulinumtoxinA', 'incobotulinumtoxinA (GFL', 'placebo-controlled or active-controlled single-dose studies']","['favorable safety and tolerability', 'incidence of AEs', ""glabellar frown lines (GFL), crow's feet (CF), and upper facial lines (UFL""]","[{'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0205132', 'cui_str': 'Linear'}]","[{'cui': 'C2930113', 'cui_str': 'IncobotulinumtoxinA'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0948887', 'cui_str': 'Glabellar frown lines'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0948887', 'cui_str': 'Glabellar frown lines'}, {'cui': 'C0277939', 'cui_str': ""Crow's feet""}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0205132', 'cui_str': 'Linear'}]",1377.0,0.0805992,"No serious treatment-related AEs were observed.
","[{'ForeName': 'William P', 'Initials': 'WP', 'LastName': 'Coleman', 'Affiliation': '*Coleman Cosmetic Dermatologic Surgery Center, Metairie, Louisiana; †Rosenpark Klinik, Darmstadt, Germany; ‡Merz Pharmaceuticals GmbH, Frankfurt am Main, Germany; §Merz North America, Inc., Raleigh, North Carolina.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Sattler', 'Affiliation': ''}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Weissenberger', 'Affiliation': ''}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Hast', 'Affiliation': ''}, {'ForeName': 'Angelika', 'Initials': 'A', 'LastName': 'Hanschmann', 'Affiliation': ''}]",Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.],['10.1097/DSS.0000000000001409']
1329,33065990,Socio-Demographic Characteristics and Body Weight Perceptions of Study Participants Benefitting Most from the Feel4Diabetes Program Based on Their Anthropometric and Glycaemic Profile Changes.,"The Feel4Diabetes program was comprised of a community-based screening and a two-year intervention phase aiming to prevent type 2 diabetes (T2D) in families at risk for diabetes across Europe. The current work aimed to identify the socio-demographic characteristics and body weight perceptions of participants who benefitted the most, achieving at least a 5% reduction in body weight, waist circumference and glycaemic indices (fasting plasma glucose, insulin, glycosylated haemoglobin levels), over two-year period. Following a two-stage screening procedure, 2294 high-risk parents were randomly allocated to standard care or more intensive intervention. The participants who benefitted most were living in Southern (OR 2.39-3.67,  p  < 0.001) and Eastern Europe (OR 1.55-2.47,  p  < 0.05), received more intensive intervention (OR 1.53-1.90,  p  = 0.002) and were younger (<40 years old) adults (OR 1.48-1.51,  p  < 0.05). Furthermore, individuals with tertiary education (OR 2.06,  p  < 0.001), who were unemployed (OR 1.62-1.68,  p  < 0.05) and perceived their body weight to be higher than normal (OR 1.58-3.00,  p  < 0.05) were more likely to benefit from the program. Lastly, males were more likely to show improvements in their glycaemic profiles compared to females (OR 1.40,  p  = 0.024). These findings point out the regions in Europe and the sociodemographic profile of individuals that benefitted the most in the current study, highlighting the need to prioritise regions in greater need for such interventions and also tailor future interventions to the characteristics and perceptions of the target populations.",2020,"The participants who benefitted most were living in Southern (OR 2.39-3.67,  p  < 0.001) and Eastern Europe (OR 1.55-2.47,  p  < 0.05), received more intensive intervention (OR 1.53-1.90,  p  = 0.002) and were younger (<40 years old) adults (OR 1.48-1.51,  p  < 0.05).",['2294 high-risk parents'],"['standard care or more intensive intervention', 'Feel4Diabetes Program']","['glycaemic profiles', 'body weight, waist circumference and glycaemic indices (fasting plasma glucose, insulin, glycosylated haemoglobin levels', 'body weight', 'Socio-Demographic Characteristics and Body Weight Perceptions']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0030551', 'cui_str': 'Parent'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",2294.0,0.0350729,"The participants who benefitted most were living in Southern (OR 2.39-3.67,  p  < 0.001) and Eastern Europe (OR 1.55-2.47,  p  < 0.05), received more intensive intervention (OR 1.53-1.90,  p  = 0.002) and were younger (<40 years old) adults (OR 1.48-1.51,  p  < 0.05).","[{'ForeName': 'George', 'Initials': 'G', 'LastName': 'Moschonis', 'Affiliation': 'Department of Dietetics, Nutrition and Sport, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, VIC 3086, Australia.'}, {'ForeName': 'Kalliopi', 'Initials': 'K', 'LastName': 'Karatzi', 'Affiliation': 'Department of Nutrition and Dietetics, School of Health Science and Education, Harokopio University, 17671 Athens, Greece.'}, {'ForeName': 'Kyriaki', 'Initials': 'K', 'LastName': 'Apergi', 'Affiliation': 'Department of Nutrition and Dietetics, School of Health Science and Education, Harokopio University, 17671 Athens, Greece.'}, {'ForeName': 'Stavros', 'Initials': 'S', 'LastName': 'Liatis', 'Affiliation': 'National and Kapodistrian University of Athens Medical School, 11527 Athens, Greece.'}, {'ForeName': 'Jemina', 'Initials': 'J', 'LastName': 'Kivelä', 'Affiliation': 'Department of Public Health Solutions, Finnish Institute for Health and Welfare, 00271 Helsinki, Finland.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Wikström', 'Affiliation': 'Department of Public Health Solutions, Finnish Institute for Health and Welfare, 00271 Helsinki, Finland.'}, {'ForeName': 'Alelí M', 'Initials': 'AM', 'LastName': 'Ayala-Marín', 'Affiliation': 'Growth, Exercise, Nutrition and Development (GENUD) Research Group, Instituto Agroalimentario de Aragón (IA2), Instituto de Investigación Sanitaria de Aragón (IIS Aragón), Universidad de Zaragoza, 50009 Zaragoza, Spain.'}, {'ForeName': 'Rocio', 'Initials': 'R', 'LastName': 'Mateo-Gallego', 'Affiliation': 'Centro de Investigación Biomédica en Red Enfermedades Cardiovasculares (CIBERCV), Instituto de Salud Carlos III, 28029 Madrid, Spain.'}, {'ForeName': 'Kaloyan', 'Initials': 'K', 'LastName': 'Tsochev', 'Affiliation': 'Department of Paediatrics, Medical University Varna, 9002 Varna, Bulgaria.'}, {'ForeName': 'Nevena', 'Initials': 'N', 'LastName': 'Chakarova', 'Affiliation': 'Clinical Center of Endocrinology, Department of Diabetology, Medical University Sofia, 1431 Sofia, Bulgaria.'}, {'ForeName': 'Emese', 'Initials': 'E', 'LastName': 'Antal', 'Affiliation': 'Hungarian Society of Nutrition, 1088 Budapest, Hungary.'}, {'ForeName': 'Imre', 'Initials': 'I', 'LastName': 'Rurik', 'Affiliation': 'Hungarian Society of Nutrition, 1088 Budapest, Hungary.'}, {'ForeName': 'Violeta', 'Initials': 'V', 'LastName': 'Iotova', 'Affiliation': 'Department of Paediatrics, Medical University Varna, 9002 Varna, Bulgaria.'}, {'ForeName': 'Greet', 'Initials': 'G', 'LastName': 'Cardon', 'Affiliation': 'Department of Movement and Sports Sciences, Faculty of Medicine and Health Sciences, Ghent University, 9000 Gent, Belgium.'}, {'ForeName': 'Jaana', 'Initials': 'J', 'LastName': 'Lindstrom', 'Affiliation': 'Department of Public Health Solutions, Finnish Institute for Health and Welfare, 00271 Helsinki, Finland.'}, {'ForeName': 'Luis A', 'Initials': 'LA', 'LastName': 'Moreno', 'Affiliation': 'Growth, Exercise, Nutrition and Development (GENUD) Research Group, Instituto Agroalimentario de Aragón (IA2), Instituto de Investigación Sanitaria de Aragón (IIS Aragón), Universidad de Zaragoza, 50009 Zaragoza, Spain.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Makrilakis', 'Affiliation': 'National and Kapodistrian University of Athens Medical School, 11527 Athens, Greece.'}, {'ForeName': 'Yannis', 'Initials': 'Y', 'LastName': 'Manios', 'Affiliation': 'Department of Nutrition and Dietetics, School of Health Science and Education, Harokopio University, 17671 Athens, Greece.'}]",Nutrients,['10.3390/nu12103117']
1330,33066009,Choline Intake as Supplement or as a Component of Eggs Increases Plasma Choline and Reduces Interleukin-6 without Modifying Plasma Cholesterol in Participants with Metabolic Syndrome.,"Metabolic syndrome (MetS) is characterized by low-grade inflammation and insulin resistance, which increase the risk of heart disease. Eggs have numerous nutrients including choline, carotenoids, and fat-soluble vitamins that may protect against these conditions. Egg phosphatidylcholine (PC) is a major contributor of dietary choline in the American diet. However, uncertainty remains regarding eggs due to their high concentration of cholesterol. In this study, we evaluated the effect of two sources of choline, whole eggs (a source of PC) and a choline supplement (choline bitartrate, CB), on plasma lipids, glucose, insulin resistance, and inflammatory biomarkers. We recruited 23 subjects with MetS to participate in this randomized cross-over intervention. After a 2-week washout, with no choline intake, participants were randomly allocated to consume three eggs/day or CB (~400 mg choline/d for both) for 4 weeks. After a 3-week washout period, they were allocated to the alternate treatment. Dietary records indicated higher concentrations of vitamin E and selenium during the egg period ( p  < 0.01). Interestingly, there were no changes in plasma total, low density lipoprotein (LDL)- or high density lipoprotein (HDL)-cholesterol, triglycerides, or glucose, compared either to baseline or between treatments. In contrast, interleukin-6 was reduced, with both sources of choline compared to baseline, while eggs also had an effect on lowering C-reactive protein, insulin, and insulin resistance compared to baseline. This study demonstrates that in a MetS population, intake of three eggs per day does not increase plasma LDL cholesterol, and has additional benefits on biomarkers of disease compared to a choline supplement, possibly due to the presence of other antioxidants in eggs.",2020,Dietary records indicated higher concentrations of vitamin E and selenium during the egg period ( p  < 0.01).,"['Participants with Metabolic Syndrome', '23 subjects with MetS to participate in this randomized cross-over intervention']","['Egg phosphatidylcholine (PC', 'CB', 'choline, whole eggs (a source of PC) and a choline supplement (choline bitartrate, CB']","['concentrations of vitamin E and selenium', 'Metabolic syndrome (MetS', 'lowering C-reactive protein, insulin, and insulin resistance', 'plasma total, low density lipoprotein (LDL)- or high density lipoprotein (HDL)-cholesterol, triglycerides, or glucose', 'plasma lipids, glucose, insulin resistance, and inflammatory biomarkers', 'plasma LDL cholesterol']","[{'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0010366', 'cui_str': 'Genetic crossing over'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0013710', 'cui_str': 'Eggs (edible)'}, {'cui': 'C1959616', 'cui_str': 'Lecithin'}, {'cui': 'C0008405', 'cui_str': 'Choline'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0008408', 'cui_str': 'Choline bitartrate'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0036581', 'cui_str': 'Selenium'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C1278073', 'cui_str': 'Plasma lipid measurement'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1278149', 'cui_str': 'Plasma LDL cholesterol measurement'}]",23.0,0.0838643,Dietary records indicated higher concentrations of vitamin E and selenium during the egg period ( p  < 0.01).,"[{'ForeName': 'Marissa', 'Initials': 'M', 'LastName': 'DiBella', 'Affiliation': 'Department of Nutritional Sciences, University of Connecticut, Storrs, CT 06269, USA.'}, {'ForeName': 'Minu S', 'Initials': 'MS', 'LastName': 'Thomas', 'Affiliation': 'Department of Nutritional Sciences, University of Connecticut, Storrs, CT 06269, USA.'}, {'ForeName': 'Hana', 'Initials': 'H', 'LastName': 'Alyousef', 'Affiliation': 'Department of Nutritional Sciences, University of Connecticut, Storrs, CT 06269, USA.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Millar', 'Affiliation': 'Department of Nutritional Sciences, University of Connecticut, Storrs, CT 06269, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Blesso', 'Affiliation': 'Department of Nutritional Sciences, University of Connecticut, Storrs, CT 06269, USA.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Malysheva', 'Affiliation': 'Division of Nutritional Sciences, Cornell University, Ithaca, NY 14853, USA.'}, {'ForeName': 'Marie A', 'Initials': 'MA', 'LastName': 'Caudill', 'Affiliation': 'Division of Nutritional Sciences, Cornell University, Ithaca, NY 14853, USA.'}, {'ForeName': 'Maria Luz', 'Initials': 'ML', 'LastName': 'Fernandez', 'Affiliation': 'Department of Nutritional Sciences, University of Connecticut, Storrs, CT 06269, USA.'}]",Nutrients,['10.3390/nu12103120']
1331,33066040,Effect of a Nutritional Support System (Diet and Supplements) for Improving Gross Motor Function in Cerebral Palsy: An Exploratory Randomized Controlled Clinical Trial.,"BACKGROUND


Most patients with cerebral palsy (CP) do not respond to physical therapy due to deterioration in their nutritional status, secondary to gastrointestinal disorders and the catabolic state of the disease itself. However, basic treatments only contemplate the energy requirements and do not consider supplementation with glutamine, zinc, selenium, colecalciferol, spirulina, omega 3 or even vegetal proteins.
OBJECTIVE


In this study, we determined the effect of using a nutritional support system (NSS): diet and supplements, on the gross motor function in children with CP with spastic diparesic and Gross Motor Function Classification System III (GMFCS III).
METHODS


An exploratory study was performed. Thirty patients (from 4 to 12 years old) were randomly assigned to: (1) dietary surveillance (FG), (2) deworming and WHO diet (CG), or (3) deworming and the NSS (IG). Gross motor function was evaluated using the gross motor function measure (GMFM) scale.
RESULTS


The IG-treated group presented a significant improvement in standing and walking parameters analyzed in the GMFM compared with FG and CG groups. Fifty percent of the IG-treated patients managed to walk, while in the other groups, no patients were able to walk.
CONCLUSIONS


The NSS used in the present work improves gross motor function and promotes walking in patients with CP.",2020,The IG-treated group presented a significant improvement in standing and walking parameters analyzed in the GMFM compared with FG and CG groups.,"['patients with cerebral palsy (CP', 'Thirty patients (from 4 to 12 years old', 'Cerebral Palsy', 'children with CP with spastic diparesic and Gross Motor Function Classification System III (GMFCS III', 'patients with CP']","['Nutritional Support System (Diet and Supplements', 'dietary surveillance (FG), (2) deworming and WHO diet (CG), or (3) deworming and the NSS (IG', 'nutritional support system (NSS): diet and supplements']","['standing and walking parameters', 'gross motor function measure (GMFM) scale', 'Gross motor function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0026838', 'cui_str': 'Spasticity'}, {'cui': 'C0677549', 'cui_str': 'Gross motor functions'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C0242739', 'cui_str': 'Nutritional support'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0199859', 'cui_str': 'Deworming'}]","[{'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0677549', 'cui_str': 'Gross motor functions'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",30.0,0.017051,The IG-treated group presented a significant improvement in standing and walking parameters analyzed in the GMFM compared with FG and CG groups.,"[{'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Leal-Martínez', 'Affiliation': 'Centro de Investigación en Ciencias de la Salud (CICSA), FCS, Universidad Anáhuac México Norte, Huixquilucan 52786, Mexico.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Franco', 'Affiliation': 'Centro de Investigación en Ciencias de la Salud (CICSA), FCS, Universidad Anáhuac México Norte, Huixquilucan 52786, Mexico.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Peña-Ruiz', 'Affiliation': 'Centro de Investigación en Ciencias de la Salud (CICSA), FCS, Universidad Anáhuac México Norte, Huixquilucan 52786, Mexico.'}, {'ForeName': 'Fabiola', 'Initials': 'F', 'LastName': 'Castro-Silva', 'Affiliation': 'Departamento de Terapia Física, Centro de Rehabilitación e Inclusión Infantil Teletón (CRIT), Tlalnepantla de Baz 54010, Mexico.'}, {'ForeName': 'Andrea A', 'Initials': 'AA', 'LastName': 'Escudero-Espinosa', 'Affiliation': 'Departamento de Terapia Física, Centro de Rehabilitación e Inclusión Infantil Teletón (CRIT), Tlalnepantla de Baz 54010, Mexico.'}, {'ForeName': 'Oscar G', 'Initials': 'OG', 'LastName': 'Rolón-Lacarrier', 'Affiliation': 'Departamento de Investigación y Enseñanza, Centro de Rehabilitación e Inclusión Infantil Teletón (CRIT), Tlalnepantla de Baz 54010, Mexico.'}, {'ForeName': 'Mardia', 'Initials': 'M', 'LastName': 'López-Alarcón', 'Affiliation': 'Unidad de Investigación Médica en Nutrición, Hospital de Pediatría CMN siglo XXI, Ciudad de Mexico 06720, Mexico.'}, {'ForeName': 'Ximena', 'Initials': 'X', 'LastName': 'De León', 'Affiliation': 'Centro de Investigación en Ciencias de la Salud (CICSA), FCS, Universidad Anáhuac México Norte, Huixquilucan 52786, Mexico.'}, {'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Linares-Eslava', 'Affiliation': 'Centro de Investigación en Ciencias de la Salud (CICSA), FCS, Universidad Anáhuac México Norte, Huixquilucan 52786, Mexico.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Ibarra', 'Affiliation': 'Centro de Investigación en Ciencias de la Salud (CICSA), FCS, Universidad Anáhuac México Norte, Huixquilucan 52786, Mexico.'}]","Foods (Basel, Switzerland)",['10.3390/foods9101449']
1332,33066868,A Longitudinal Training Study to Delineate the Specific Causal Effects of Open Monitoring Versus Focused Attention Techniques on Emotional Health.,"BACKGROUND


Emotional dysregulation is a core mechanism of mood disorders. Meditation-based interventions can ameliorate a wide range of psychological problems. However, in order to develop structured treatment and preventative protocols for emotional disorders, it is crucial to understand how different types of specific meditation practices improve emotion regulation abilities. Mindfulness-based techniques are broadly separated into two practices - open monitoring (OM) and focused attention (FA). This study directly investigated the potential practice-specific benefits of OM versus FA techniques as tools for improving emotion regulation skills from pre-to-post training.
METHOD


Novice participants were randomized into an 8-week long OM or FA intervention that was previously developed through a science of behavior change approach. Healthy emotional skills were assessed using experience sampling methodology and inventories. Participants were assessed before, during, and after the interventions to investigate if the type of training may explain longitudinal changes in emotional skills.
RESULTS


Both OM and FA attentional training practices improved acceptance of stressors and reduced distress and rumination. We also found divergent effects of OM versus FA training: Compared to OM, FA training improved abilities to use reappraisal strategy to regulate emotions in naturalistic settings at the end of 8-weeks training. FA training (versus OM) also led to greater self-regulation abilities.
CONCLUSION


Our findings suggest that a FA training has specific causal impacts on emotion regulatory skills, and it can be selectively implemented in interventions to target emotional disorders.",2020,"Compared to OM, FA training improved abilities to use reappraisal strategy to regulate emotions in naturalistic settings at the end of 8-weeks training.",['Novice participants'],"['Meditation-based interventions', 'FA training (versus OM', 'Open Monitoring Versus Focused Attention Techniques', 'OM, FA training', 'OM versus FA training', 'OM and FA attentional training practices', 'OM or FA intervention', 'OM versus FA techniques', 'FA training']","['Healthy emotional skills', 'acceptance of stressors and reduced distress and rumination', 'emotion regulation skills']",[],"[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0589098', 'cui_str': 'Focused attention'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0154575', 'cui_str': 'Rumination disorder'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}]",,0.0188353,"Compared to OM, FA training improved abilities to use reappraisal strategy to regulate emotions in naturalistic settings at the end of 8-weeks training.","[{'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Lohani', 'Affiliation': 'Department of Educational Psychology, University of Utah, United States. Electronic address: Monika.Lohani@utah.edu.'}, {'ForeName': 'Kara', 'Initials': 'K', 'LastName': 'McElvaine', 'Affiliation': 'Human Development and Family Studies, Oregon State University, United States.'}, {'ForeName': 'Brennan', 'Initials': 'B', 'LastName': 'Payne', 'Affiliation': 'Department of Psychology, University of Utah, United States.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Mitcheom', 'Affiliation': 'Mindfulness Center, Brown University School of Public Health, United States.'}, {'ForeName': 'Willoughby', 'Initials': 'W', 'LastName': 'Britton', 'Affiliation': 'Department of Psychiatry and Human Behavior, Warren Alpert Medical School, Brown University, United States.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102525']
1333,33066869,Folic acid and vitamin B12 supplementation in subjects with type 2 diabetes mellitus: A multi-arm randomized controlled clinical trial.,"OBJECTIVE


This study was conducted to investigate and compare the effects of add-on folic acid and vitamin B12 supplementation on glycaemic control, insulin resistance and serum lipid profile in subjects with type 2 diabetes mellitus.
STUDY DESIGN & INTERVENTION


This study was a randomized, multi-arm, open-label clinical trial. 80 patients with type 2 diabetes and on stable oral antidiabetics were enrolled and 20 patients each were randomly allocated to one of the four groups - Group A: add-on Folic acid (5 mg/day); Group B: add-on Methylcobalamin (500 mcg/day); Group C: add-on Folic acid (5 mg/day) + Methylcobalamin (500 mcg/day) and Group D: Standard oral anti-diabetic drugs. The patients were followed up after 8 weeks.
RESULTS


HbA1c improved significantly in Groups B and C [median changes from baseline - 1.2 % (- 13 mmol/mol) and - 1.5 % (- 16 mmol/mol) respectively, p values 0.04 and 0.02 respectively] compared to Group D. Groups B and C also showed significant improvements in plasma insulin, insulin resistance and serum adiponectin compared to Group D. Serum homocysteine declined significantly in all three groups with add-on supplementation compared to standard treatment. No improvement in the lipid profile was noted in any of the groups.
CONCLUSIONS


Add-on supplementation with vitamin B12 improved glycaemic control and insulin resistance in patients with type 2 diabetes mellitus.",2020,"No improvement in the lipid profile was noted in any of the groups.
","['patients with type 2 diabetes mellitus', 'subjects with type 2 diabetes mellitus', '80 patients with type 2 diabetes and on stable oral antidiabetics were enrolled and 20 patients each']","['Folic acid and vitamin B12 supplementation', 'vitamin B12', 'Folic acid (5\u202fmg/day); Group B: add-on Methylcobalamin', 'folic acid and vitamin B12 supplementation', 'Folic acid (5\u202fmg/day) + Methylcobalamin (500 mcg/day) and Group D: Standard oral anti-diabetic drugs']","['glycaemic control, insulin resistance and serum lipid profile', 'plasma insulin, insulin resistance and serum adiponectin', 'lipid profile', 'Serum homocysteine', 'glycaemic control and insulin resistance']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0935929', 'cui_str': 'Antidiabetic agent'}]","[{'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C4524262', 'cui_str': 'Vitamin B12 supplementation'}, {'cui': 'C0042845', 'cui_str': 'Vitamin B 12'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0065844', 'cui_str': 'mecobalamin'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0439426', 'cui_str': 'ug/day'}, {'cui': 'C0441838', 'cui_str': 'Group D'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0428462', 'cui_str': 'Measurement of serum lipid level'}, {'cui': 'C0857690', 'cui_str': 'Plasma insulin'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0019878', 'cui_str': 'Homocysteine'}]",80.0,0.0647814,"No improvement in the lipid profile was noted in any of the groups.
","[{'ForeName': 'Swayamjeet', 'Initials': 'S', 'LastName': 'Satapathy', 'Affiliation': 'All India Institute of Medical Sciences, Bhubaneswar, 751019, India.'}, {'ForeName': 'Debapriya', 'Initials': 'D', 'LastName': 'Bandyopadhyay', 'Affiliation': 'Department of Biochemistry, All India Institute of Medical Sciences, Bhubaneswar, 751019, India. Electronic address: debudoc2000@gmail.com.'}, {'ForeName': 'Binod Kumar', 'Initials': 'BK', 'LastName': 'Patro', 'Affiliation': 'Department of Community Medicine and Family Medicine, All India Institute of Medical Sciences, Bhubaneswar, 751019, India.'}, {'ForeName': 'Shahnawaz', 'Initials': 'S', 'LastName': 'Khan', 'Affiliation': 'All India Institute of Medical Sciences, Bhubaneswar, 751019, India.'}, {'ForeName': 'Sanjukta', 'Initials': 'S', 'LastName': 'Naik', 'Affiliation': 'Department of Biochemistry, All India Institute of Medical Sciences, Bhubaneswar, 751019, India.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102526']
1334,33066879,Exploring the Economic Benefits of Modafinil for Post-Stroke Fatigue in Australia: A Cost-Effectiveness Evaluation.,"BACKGROUND


In stroke survivors, post-stroke fatigue predicts dependency in daily living and failure to return to work. Modafinil shows promise as a pharmacotherapy to reduce post-stroke fatigue and related sequelae, e.g., poorer functional and clinical outcomes.
AIMS


This study explored the cost-effectiveness of modafinil in treating post-stroke fatigue in the Australian context, by determining its incremental cost-effectiveness ratio (ICER) and by simulating the potential cost-savings on a national scale, through a re-analysis of MIDAS trial data.
METHODS


A post hoc cost-effectiveness analysis was undertaken. Part A: patient-level cost and health effect data (Multidimensional Fatigue Inventory (MFI) scores) were derived from the MIDAS trial and analysis undertaken from a health-system perspective. Part B: a secondary analysis simulated the societal impact of modafinil therapy in terms of national productivity costs.
RESULTS


Part A: Mean cost of modafinil treatment was AUD$3.60/day/patient for a minimally clinically important change (10 points) in total MFI fatigue score, i.e., AUD$0.36/day/unit change in fatigue score per patient. For the base case scenario, the ICER of using modafinil (versus placebo) was AUD$131.73 ($90.17 - 248.15, for minimum and maximum costs, respectively). Part B: The potential productivity cost-savings to society were calculated as nearly AUD$467 million over 1 year, and up to $383,471,991,248 over 10 years, from the widespread use of modafinil treatment in the Australian population of working-age stroke-survivors, representing a significant societal benefit.
CONCLUSIONS


Modafinil is a highly cost-effective treatment for post-stroke fatigue, offering significant productivity gains and potential cost-savings to society from the widespread use of modafinil treatment in the Australian population of working-age stroke-survivors.",2020,"Modafinil shows promise as a pharmacotherapy to reduce post-stroke fatigue and related sequelae, e.g., poorer functional and clinical outcomes.
","['Part B', 'Post-Stroke Fatigue in Australia']","['Modafinil', 'modafinil', 'modafinil therapy', 'modafinil (versus placebo']","['total MFI fatigue score, i.e., AUD$0.36/day/unit change in fatigue score', 'level cost and health effect data (Multidimensional Fatigue Inventory (MFI) scores', 'incremental cost-effectiveness ratio (ICER']","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0066677', 'cui_str': 'modafinil'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",,0.169519,"Modafinil shows promise as a pharmacotherapy to reduce post-stroke fatigue and related sequelae, e.g., poorer functional and clinical outcomes.
","[{'ForeName': 'Beata', 'Initials': 'B', 'LastName': 'Bajorek', 'Affiliation': 'Academic Pharmacist - Graduate School of Health, University of Technology Sydney, Broadway, New South Wales 2007, Australia; Research Affiliate - Hunter Medical Research Institute, New South Wales, Australia. Electronic address: beata.bajorek@uts.edu.au.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Gao', 'Affiliation': 'Senior Lecturer - Deakin Health Economics, Institute for Health Transformation, Deakin University, Geelong, Victoria 3127, Australia. Electronic address: lan.gao@deakin.edu.au.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Lillicrap', 'Affiliation': 'Academic Pharmacist - Graduate School of Health, University of Technology Sydney, Broadway, New South Wales 2007, Australia; Clinical Scientist - Neurology Department, John Hunter Hospital, New Lambton Heights, New South Wales 2305, Australia. Electronic address: tom.lillicrap@newcastle.edu.au.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Bivard', 'Affiliation': 'Research Affiliate - Hunter Medical Research Institute, New South Wales, Australia; Principle Research Fellow - Melbourne School of Health Sciences - Faculty of Medicine, Dentistry and Health Sciences, Victoria, Australia. Electronic address: abivard@unimelb.edu.au.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Garcia-Esperon', 'Affiliation': 'Research Affiliate - Hunter Medical Research Institute, New South Wales, Australia; Stroke Neurologist - Department of Neurology, John Hunter Hospital, New Lambton Heights, New South Wales 2305, Australia. Electronic address: Carlos.GarciaEsperon@health.nsw.gov.au.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Parsons', 'Affiliation': 'Research Affiliate - Hunter Medical Research Institute, New South Wales, Australia; Director of Neurology - Department of Neurology, Royal Melbourne Hospital, Parkville, Victoria 3052, Australia. Electronic address: Mark.Parsons@mh.org.au.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Spratt', 'Affiliation': 'Research Affiliate - Hunter Medical Research Institute, New South Wales, Australia; Stroke Neurologist - Department of Neurology, John Hunter Hospital, New Lambton Heights, New South Wales 2305, Australia; School of Biomedical Sciences, University of Newcastle, Australia. Electronic address: neil.spratt@health.nsw.gov.au.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Holliday', 'Affiliation': 'Research Affiliate - Hunter Medical Research Institute, New South Wales, Australia; School of Medicine and Public Health, University of Newcastle, Callaghan, New South Wales 2308, Australia. Electronic address: liz.holliday@newcastle.edu.au.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Levi', 'Affiliation': 'Research Affiliate - Hunter Medical Research Institute, New South Wales, Australia; The Sydney Partnership for Health, Education, Research, and Enterprise (SPHERE), Liverpool, New South Wales 2170, Australia. Electronic address: christopher.levi@unsw.edu.au.'}]",Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association,['10.1016/j.jstrokecerebrovasdis.2020.105213']
1335,33066893,Ipsilateral Nonstenotic Carotid Disease in Minor Ischemic Stroke: an Exploratory Analysis of The POINT Randomized Clinical Trial.,"BACKGROUND AND AIM


Ipsilateral nonstenotic carotid disease is increasingly recognized as an etiology of ischemic stroke, however tailored treatment strategies are lacking. We aimed to examine clinical characteristics and treatment effects in patients with minor ischemic stroke associated with ipsilateral nonstenotic carotid disease in the Platelet Oriented Inhibition in New TIA and Minor Ischemic Stroke (POINT) trial.
METHODS


We performed an exploratory analysis of the interaction of the treatment effects of aspirin plus clopidogrel versus aspirin monotherapy, stratified by presence of ipsilateral nonstenotic carotid disease in patients with minor ischemic stroke in the POINT trial.
RESULTS


For this exploratory analysis, 167 patients presenting with ischemic stroke and ipsilateral nonstenotic carotid disease, defined as 1%-49% carotid stenosis ipsilateral to the corresponding territory of ischemic stroke, and 833 patients no carotid disease were included. Compared to patients with no carotid disease, patients with ipsilateral nonstenotic carotid disease were older (68.5 ± 11.3 years versus 61.3 ± 12.8 years; P < 0.001), and had a higher prevalence of hypertension (76.6% versus 59.2%, P < 0.001), ischemic heart disease (13.8% versus 5.4%, P < 0.001), and tobacco use (past: 34.1% versus 25.2%, P = 0.005; present: 27.5% versus 22.8%, P = 0.005). 5.4% of patients with ipsilateral nonstenotic carotid disease had recurrent ischemic stroke within 14 days. Patients receiving dual antiplatelet therapy had a numerical reduction in recurrent ischemic stroke compared to patients receiving aspirin monotherapy, however the exploratory analysis was underpowered to detect a statistically significant difference in treatment effect (HR 0.50, 95% CI 0.18-1.40, P = 0.19).
CONCLUSION


Patients with minor ischemic stroke and ipsilateral nonstenotic carotid disease had a high risk of early stroke recurrence in the POINT trial. Dual antiplatelet therapy provided a non-statistically significant reduction in recurrent ischemic stroke with no difference in safety outcomes compared to aspirin monotherapy. Further study is needed to determine if early and short duration dual antiplatelet therapy is beneficial for all patients with ipsilateral nonstenotic carotid disease.",2020,Dual antiplatelet therapy provided a non-statistically significant reduction in recurrent ischemic stroke with no difference in safety outcomes compared to aspirin monotherapy.,"['Minor Ischemic Stroke', 'patients with minor ischemic stroke in the POINT trial', '167 patients presenting with ischemic stroke and ipsilateral nonstenotic carotid disease, defined as 1%-49% carotid stenosis ipsilateral to the corresponding territory of ischemic stroke, and 833 patients no carotid disease were included', 'patients with ipsilateral nonstenotic carotid disease', 'patients with minor ischemic stroke associated with ipsilateral nonstenotic carotid disease in the Platelet Oriented Inhibition in New TIA and Minor Ischemic Stroke (POINT) trial', 'Patients with minor ischemic stroke and ipsilateral nonstenotic carotid disease']","['aspirin plus clopidogrel', 'aspirin monotherapy', 'dual antiplatelet therapy']","['recurrent ischemic stroke', 'high risk of early stroke recurrence', 'ipsilateral nonstenotic carotid disease', 'prevalence of hypertension', 'ischemic heart disease']","[{'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4517595', 'cui_str': '167'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0007282', 'cui_str': 'Carotid artery stenosis'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C5191298', 'cui_str': '833'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}]","[{'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0151744', 'cui_str': 'Myocardial ischemia'}]",167.0,0.156056,Dual antiplatelet therapy provided a non-statistically significant reduction in recurrent ischemic stroke with no difference in safety outcomes compared to aspirin monotherapy.,"[{'ForeName': 'Zachary', 'Initials': 'Z', 'LastName': 'Bulwa', 'Affiliation': 'Department of Neurology, University of Chicago Medical Center, 5841 South Maryland Avenue MC 2030, Chicago, IL 60637, USA. Electronic address: zachary.bulwa@uchospitals.edu.'}, {'ForeName': 'Faddi G', 'Initials': 'FG', 'LastName': 'Saleh Velez', 'Affiliation': 'Department of Neurology, University of Chicago Medical Center, 5841 South Maryland Avenue MC 2030, Chicago, IL 60637, USA. Electronic address: faddi.salehvelez@uchospitals.edu.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Brorson', 'Affiliation': 'Department of Neurology, University of Chicago Medical Center, 5841 South Maryland Avenue MC 2030, Chicago, IL 60637, USA. Electronic address: jbrorson@neurology.bsd.uchicago.edu.'}, {'ForeName': 'Camila B', 'Initials': 'CB', 'LastName': 'Pinto', 'Affiliation': 'University of Sao Paulo, Institute of Psychology, Sao Paulo, Brazil. Electronic address: cboninpinto@gmail.com.'}]",Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association,['10.1016/j.jstrokecerebrovasdis.2020.105115']
1336,33067287,Treatment success of internet-based vestibular rehabilitation in general practice: development and internal validation of a prediction model.,"OBJECTIVES


To develop and internally validate prediction models to assess treatment success of both stand-alone and blended online vestibular rehabilitation (VR) in patients with chronic vestibular syndrome.
DESIGN


Secondary analysis of a randomised controlled trial.
SETTING


59 general practices in The Netherlands.
PARTICIPANTS


202 adults, aged 50 years and older with a chronic vestibular syndrome who received either stand-alone VR (98) or blended VR (104). Stand-alone VR consisted of a 6-week, internet-based intervention with weekly online sessions and daily exercises. In blended VR, the same intervention was supplemented with physiotherapy support.
MAIN OUTCOME MEASURES


Successful treatment was defined as: clinically relevant improvement of (1) vestibular symptoms (≥3 points improvement Vertigo Symptom Scale-Short Form); (2) vestibular-related disability (>11 points improvement Dizziness Handicap Inventory); and (3) both vestibular symptoms and vestibular-related disability. We assessed performance of the predictive models by applying calibration plots, Hosmer-Lemeshow statistics, area under the receiver operating characteristic curves (AUC) and applied internal validation.
RESULTS


Improvement of vestibular symptoms, vestibular-related disability or both was seen in 121, 81 and 64 participants, respectively. We generated predictive models for each outcome, resulting in different predictors in the final models. Calibration for all models was adequate with non-significant Hosmer-Lemeshow statistics, but the discriminative ability of the final predictive models was poor (AUC 0.54 to 0.61). None of the identified models are therefore suitable for use in daily general practice to predict treatment success of online VR.
CONCLUSION


It is difficult to predict treatment success of internet-based VR and it remains unclear who should be treated with stand-alone VR or blended VR. Because we were unable to develop a useful prediction model, the decision to offer stand-alone or blended VR should for now be based on availability, cost effectiveness and patient preference.
TRIAL REGISTRATION NUMBER


The Netherlands Trial Register NTR5712.",2020,"RESULTS


Improvement of vestibular symptoms, vestibular-related disability or both was seen in 121, 81 and 64 participants, respectively.","['patients with chronic vestibular syndrome', '59 general practices in The Netherlands', '202 adults, aged 50 years and older with a chronic vestibular syndrome who received either stand-alone VR (98) or blended VR (104']","['internet-based vestibular rehabilitation', 'stand-alone and blended online vestibular rehabilitation (VR']","['vestibular symptoms, vestibular-related disability', 'Dizziness Handicap Inventory); and (3) both vestibular symptoms and vestibular-related disability', 'clinically relevant improvement of (1) vestibular symptoms (≥3 points improvement Vertigo Symptom Scale-Short Form); (2) vestibular-related disability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0560204', 'cui_str': 'Does stand alone'}, {'cui': 'C0200324', 'cui_str': 'Vestibular rehabilitation'}, {'cui': 'C4517527', 'cui_str': '104'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0200324', 'cui_str': 'Vestibular rehabilitation'}, {'cui': 'C0560204', 'cui_str': 'Does stand alone'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0231172', 'cui_str': 'Handicap'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0042571', 'cui_str': 'Vertigo'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}]",202.0,0.0271032,"RESULTS


Improvement of vestibular symptoms, vestibular-related disability or both was seen in 121, 81 and 64 participants, respectively.","[{'ForeName': 'Vincent A', 'Initials': 'VA', 'LastName': 'van Vugt', 'Affiliation': 'Department of General Practice, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands v.vanvugt@amsterdamumc.nl.'}, {'ForeName': 'Martijn W', 'Initials': 'MW', 'LastName': 'Heymans', 'Affiliation': 'Amsterdam Public Health Research Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Johannes C', 'Initials': 'JC', 'LastName': 'van der Wouden', 'Affiliation': 'Department of General Practice, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Henriëtte E', 'Initials': 'HE', 'LastName': 'van der Horst', 'Affiliation': 'Department of General Practice, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Otto R', 'Initials': 'OR', 'LastName': 'Maarsingh', 'Affiliation': 'Department of General Practice, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}]",BMJ open,['10.1136/bmjopen-2020-038649']
1337,33068669,"The effect of transcranial direct current stimulation (tDCS) on food craving, reward and appetite in a healthy population.","The ability to control hedonic appetite is associated with executive functioning, originating in the prefrontal cortex (PFC). These rewarding components of food can override homeostatic mechanisms, potentiating obesogenic behaviours. Indeed, those susceptible to overconsumption appear to have PFC hypo-activation. Transcranial direct current stimulation (tDCS) over the dorsolateral PFC (DLPFC) has been shown to reduce food craving and consumption, potentially via attenuating this reward response. We examined the effects of stimulation on food reward and craving using a healthy-weight cohort. This study is amongst the first to explore the effects of tDCS on explicit and implicit components of reward for different food categories. Twenty-one healthy-weight participants (24 ± 7 years, 22.8 ± 2.3 kg m -2 ) completed two sessions involving double-blind, randomised and counterbalanced anodal or sham tDCS over the right DLPFC, at 2 mA for 20 min. Food craving (Food Craving Questionnaire-State), reward (Leeds Food Preference Questionnaire), and subjective appetite (100 mm visual analogue scales) were measured pre- and post-tDCS. Eating behaviour trait susceptibility was assessed using the Three Factor Eating Questionnaire-Short Form, Control of Eating Questionnaire, and Food Craving Questionnaire-Trait-reduced. Stimulation did not alter food craving, reward or appetite in healthy-weight participants who displayed low susceptibility to overconsumption, with low trait craving, good craving control, and low uncontrolled eating and emotional eating behaviour. Implicit and explicit reward were reliable measures of hedonic appetite, suggesting these are robust targets for future tDCS research. These findings suggest that applying tDCS over the DLPFC does not change food reward response in individuals not at risk for overconsumption, and future work should focus on those at risk of overconsumption who may be more responsive to the effects of tDCS on hedonic appetite.",2020,"Stimulation did not alter food craving, reward or appetite in healthy-weight participants who displayed low susceptibility to overconsumption, with low trait craving, good craving control, and low uncontrolled eating and emotional eating behaviour.","['healthy-weight cohort', 'healthy population', 'Twenty-one healthy-weight participants (24 ± 7 years, 22.8 ± 2.3 kg·m -2 ', 'healthy-weight participants who displayed low susceptibility to overconsumption, with low trait craving, good craving control, and low uncontrolled eating and emotional eating behaviour']","['Transcranial direct current stimulation (tDCS', 'dorsolateral PFC (DLPFC', 'transcranial direct current stimulation (tDCS', 'counterbalanced anodal or sham tDCS', 'tDCS']","['food reward and craving', 'Factor Eating Questionnaire-Short Form, Control of Eating Questionnaire, and Food Craving Questionnaire-Trait-reduced', 'Food craving (Food Craving Questionnaire-State), reward (Leeds Food Preference Questionnaire), and subjective appetite (100 mm visual analogue scales', 'hedonic appetite', 'food craving, reward and appetite', 'Eating behaviour trait susceptibility', 'food craving, reward or appetite']","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C2983598', 'cui_str': 'Dorsolateral'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0872380', 'cui_str': 'Food craving'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0016483', 'cui_str': 'Food Preferences'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}]",21.0,0.0334459,"Stimulation did not alter food craving, reward or appetite in healthy-weight participants who displayed low susceptibility to overconsumption, with low trait craving, good craving control, and low uncontrolled eating and emotional eating behaviour.","[{'ForeName': 'Jordan D', 'Initials': 'JD', 'LastName': 'Beaumont', 'Affiliation': 'School of Social and Health Sciences, Leeds Trinity University, Leeds, LS18 5HD, UK. Electronic address: j.beaumont@leedstrinity.ac.uk.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Davis', 'Affiliation': 'School of Social and Health Sciences, Leeds Trinity University, Leeds, LS18 5HD, UK.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Dalton', 'Affiliation': 'School of Social and Health Sciences, Leeds Trinity University, Leeds, LS18 5HD, UK.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Nowicky', 'Affiliation': 'Centre for Cognitive Neuroscience, Department of Clinical Sciences, College of Health and Life Sciences, Brunel University London, Uxbridge, UB8 3PH, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Russell', 'Affiliation': 'School of Social and Health Sciences, Leeds Trinity University, Leeds, LS18 5HD, UK.'}, {'ForeName': 'Martin J', 'Initials': 'MJ', 'LastName': 'Barwood', 'Affiliation': 'School of Social and Health Sciences, Leeds Trinity University, Leeds, LS18 5HD, UK.'}]",Appetite,['10.1016/j.appet.2020.105004']
1338,33069063,Reliability of ultrasound measurement for isolated control of the transversus abdominis muscle during abdominal hollowing: A secondary analysis.,"Ultrasonography (US) measurements of the transversus abdominis muscle (TrA) during abdominal hollowing (AH) are conducted at the maximum AH, which would be unable to evaluate isolated control of the TrA to the internal or external oblique muscles (outer muscles). The present study aimed to establish a reliable method to evaluate the skills of isolated control of the TrA to the outer muscles using US. The datasets of two follow-ups were analyzed with 1-week interval of a wait-and-see control group comprising 20 participants with LBP in a randomized controlled trial. The primary measures were; % change in the thickness of the TrA at 1 cm lateral to the muscle-fascia junction of the TrA, and changes in horizontal distance of the superior edge of the TrA fascia. The measurement time points were immediately before AH during resting and when outer muscle thickness above 1 cm lateral to the muscle-fascia junction of the TrA increased by 10%. Consequently, five repetitions were required to obtain a stable mean value and good reliability (intraclass correlation coefficient [ICC] (1,5)  = 0.65-0.68 for the % change, and 0.84-0.88 for the change in horizontal distance; ICC (2,5)  = 0.82 for the % change, and 0.93 for the change in horizontal distance).",2020,The present study aimed to establish a reliable method to evaluate the skills of isolated control of the TrA to the outer muscles using US.,[],"['ICC', 'Ultrasonography (US) measurements of the transversus abdominis muscle (TrA) during abdominal hollowing (AH']","['thickness of the TrA at 1\xa0cm lateral to the muscle-fascia junction of the TrA, and changes in horizontal distance of the superior edge of the TrA fascia']",[],"[{'cui': 'C0242349', 'cui_str': 'Immunocytochemical procedure'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0224378', 'cui_str': 'Structure of transversus abdominis muscle'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}]","[{'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0015641', 'cui_str': 'Fascial'}, {'cui': 'C0205144', 'cui_str': 'Junctional'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0205154', 'cui_str': 'Along edge'}]",20.0,0.0294516,The present study aimed to establish a reliable method to evaluate the skills of isolated control of the TrA to the outer muscles using US.,"[{'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Takasaki', 'Affiliation': 'Department of Physical Therapy, Saitama Prefectural University, Koshigaya, Saitama, Japan. Electronic address: physical.therapy.takasaki@gmail.com.'}, {'ForeName': 'Shota', 'Initials': 'S', 'LastName': 'Kawazoe', 'Affiliation': 'Department of Physical Therapy, Saitama Prefectural University, Koshigaya, Saitama, Japan.'}]",Journal of electromyography and kinesiology : official journal of the International Society of Electrophysiological Kinesiology,['10.1016/j.jelekin.2020.102476']
1339,33069106,Brief mindfulness training for smoking cessation in Chinese women in workplaces: A pilot randomized controlled trial.,"INTRODUCTION


Mindfulness training (MT) has shown preliminary efficacy as a behavioral treatment for smoking cessation. We examined the effect of a brief-MT intervention on smoking cessation for Chinese women in workplaces in Hong Kong, China.
METHODS


In this pilot randomized controlled trial, 213 daily smokers were recruited from workplaces and computer-randomized into the intervention (n = 114) or control (n = 99) groups. Participants in both groups received a self-help booklet. Participants in the intervention group additionally attended 2 sessions of a brief-MT workshop. The primary outcome was self-reported 7-day point-prevalence abstinence (PPA) at 6 months. Secondary outcomes were biochemically validated abstinence (exhaled CO < 4 ppm and salivary cotinine < 10 ng/mL) and smoking reduction at 6 months. Analyses were done by intention to treat. We conducted a post-trial qualitative evaluation on participants in the intervention group (n = 14). Data were analyzed thematically.
RESULTS


At 6-month follow-up, self-reported 7-day PPA were similar between the intervention and control groups (18.4% vs. 21.2%; P = 0.61). Very few participated in biochemical validation (n = 17), and validated abstinence and smoking reduction rates showed no significant difference (5.3% vs. 11.1%, P = 0.12 and 20.2% vs. 20.2%, P = 1.00, respectively). A posteriori analysis showed that brief-MT participants who were psychologically engaged with the intervention had greater 6-month PPA. Qualitative evaluation showed brief-MT reduced stress but its effectiveness was restrained by the insufficient home practice.
CONCLUSIONS


This pilot trial on a brief-MT intervention for smoking cessation on Chinese women in workplaces showed feasibility, but improving compliance is needed to maximize the efficacy in future fully powered trials.",2020,"At 6-month follow-up, self-reported 7-day PPA were similar between the intervention and control groups (18.4% vs. 21.2%; P = 0.61).","['Chinese women in workplaces', 'participants in the intervention group (n\xa0=\xa014', 'Chinese women in workplaces in Hong Kong, China', '213 daily smokers were recruited from workplaces and computer-randomized into the intervention (n\xa0=\xa0114) or control (n\xa0=\xa099) groups']","['self-help booklet', 'Mindfulness training (MT', 'MT intervention', 'brief-MT intervention', 'Brief mindfulness training']","['validated abstinence and smoking reduction rates', 'smoking reduction', '6-month PPA', 'smoking cessation', '7-day PPA', 'self-reported 7-day point-prevalence abstinence (PPA', 'salivary cotinine']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C3266136', 'cui_str': 'Smokes tobacco daily'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}]","[{'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C4505208', 'cui_str': 'Smoking Reduction'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0010194', 'cui_str': 'Cotinine'}]",213.0,0.102459,"At 6-month follow-up, self-reported 7-day PPA were similar between the intervention and control groups (18.4% vs. 21.2%; P = 0.61).","[{'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Weng', 'Affiliation': 'School of Nursing, University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Tzu Tsun', 'Initials': 'TT', 'LastName': 'Luk', 'Affiliation': 'School of Nursing, University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Oi Sze', 'Initials': 'OS', 'LastName': 'Lau', 'Affiliation': 'The Lok Sin Tong Benevolent Society Kowloon, Hong Kong SAR, China.'}, {'ForeName': 'Yi Nam', 'Initials': 'YN', 'LastName': 'Suen', 'Affiliation': 'Department of Psychiatry, University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Jung Jae', 'Initials': 'JJ', 'LastName': 'Lee', 'Affiliation': 'School of Nursing, University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'William Ho-Cheung', 'Initials': 'WH', 'LastName': 'Li', 'Affiliation': 'School of Nursing, University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Jojo Yan Yan', 'Initials': 'JYY', 'LastName': 'Kwok', 'Affiliation': 'School of Nursing, University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Tai Hing', 'Initials': 'TH', 'LastName': 'Lam', 'Affiliation': 'School of Public Health, University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Man Ping', 'Initials': 'MP', 'LastName': 'Wang', 'Affiliation': 'School of Nursing, University of Hong Kong, Hong Kong SAR, China. Electronic address: mpwang@hku.hk.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106677']
1340,33069109,Behavioral modification decreases approach bias in young adults with internet gaming disorder.,"BACKGROUND


One of the key symptoms of Internet gaming disorder is the impulsive pursuit of Internet games, which causes individuals with this disorder to have a tendency to approach gaming cues. Dual processing theory states that this approach bias is caused by the suppression of reflective processing and the hyperactivity of impulsive processing. Therefore, reverse modification training for approach bias can suppress impulsive processing, thereby reducing or treating the disorder.
METHOD


In this study, 48 individuals with Internet gaming disorder were selected and randomly assigned to the following two groups: the experimental group and the control group. The 24 participants in the experimental group received a 4-day stimulus-response compatibility (SRC) approach bias modification treatment, whereas the 24 participants in the control group received a corresponding SRC pseudomodification training.
RESULTS


The approach response time of both groups to the gaming cues was significantly shorter than that to the neutral cues at baseline. After the modification, the response time of the experimental group to the gaming cues significantly increased, whereas the scores for Internet gaming disorder severity, anxiety level and craving significantly decreased. However, the control group subjects did not show these effects.
CONCLUSION


The current results imply that individuals with Internet gaming disorder show approach bias toward Internet gaming cues, and SRC reverse modification training can significantly correct this bias and therefore have therapeutic effects to some extent.",2020,"After the modification, the response time of the experimental group to the gaming cues significantly increased, whereas the scores for Internet gaming disorder severity, anxiety level and craving significantly decreased.","['young adults with internet gaming disorder', 'individuals with Internet gaming disorder', '48 individuals with Internet gaming disorder']","['4-day stimulus-response compatibility (SRC) approach bias modification treatment', 'corresponding SRC pseudomodification training', 'Behavioral modification']","['scores for Internet gaming disorder severity, anxiety level and craving', 'response time', 'gaming cues']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C4760905', 'cui_str': 'Internet gaming disorder'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4760905', 'cui_str': 'Internet gaming disorder'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0010439', 'cui_str': 'Cues'}]",48.0,0.0253849,"After the modification, the response time of the experimental group to the gaming cues significantly increased, whereas the scores for Internet gaming disorder severity, anxiety level and craving significantly decreased.","[{'ForeName': 'Jinbo', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'Key Laboratory of Adolescent Cyberpsychology and Behavior of Ministry of Education, Key Laboratory of Human Development and Mental Health of Hubei Province, School of Psychology, Central China Normal University, Wuhan, China. Electronic address: hjb@mail.ccnu.edu.cn.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Pan', 'Affiliation': 'Key Laboratory of Adolescent Cyberpsychology and Behavior of Ministry of Education, Key Laboratory of Human Development and Mental Health of Hubei Province, School of Psychology, Central China Normal University, Wuhan, China.'}, {'ForeName': 'Yufeng', 'Initials': 'Y', 'LastName': 'Nie', 'Affiliation': 'Key Laboratory of Adolescent Cyberpsychology and Behavior of Ministry of Education, Key Laboratory of Human Development and Mental Health of Hubei Province, School of Psychology, Central China Normal University, Wuhan, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': 'Key Laboratory of Adolescent Cyberpsychology and Behavior of Ministry of Education, Key Laboratory of Human Development and Mental Health of Hubei Province, School of Psychology, Central China Normal University, Wuhan, China.'}, {'ForeName': 'Suqing', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Key Laboratory of Adolescent Cyberpsychology and Behavior of Ministry of Education, Key Laboratory of Human Development and Mental Health of Hubei Province, School of Psychology, Central China Normal University, Wuhan, China.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106686']
1341,33069121,Add-on memantine may improve cognitive functions and attenuate inflammation in middle- to old-aged bipolar II disorder patients.,"OBJECTIVES


Chronic inflammation and neuroprogression underlie bipolar disorder (BP) and associated cognitive deficits. Memantine (MM) exerts neuroprotective effects by reducing neuroinflammation. Therefore, we investigated whether add-on low-dose MM (5 mg/day) in BP-II patients may improve cognition and inflammation.
METHODS


We combined two 12-week randomized, double-blind, placebo-controlled studies (NCT01188148 and NCT03039842) for analysis. Each participant was allocated to the MM or placebo group. Symptom severity, neuropsychological tests, and the cytokine plasma levels [tumor necrosis factor-α (TNF-α), C-reactive protein (CRP), interleukin-8 (IL-8), transforming growth factor-β1 (TGF-β1), and brain-derived neurotrophic factor (BDNF)] were evaluated at baseline and endpoint. A subgroup analysis of middle- to old-aged BP-II patients was also performed.
RESULTS


We recruited 155 BP-II patients (23 of which were middle- to old-aged) for the MM group and 170 patients (20 of which were middle- to old-aged) for the placebo group. Add-on MM did not result in significant improvements in cognitive functions in all BP-II patients, but a group difference in TNF-α levels was found in the MM group (P=0.04). Specifically, in middle- to old-aged BP-II patients, there was a significant time and group interaction effect on omission T-scores, hit reaction time T-scores, and hit reaction time standard error T-scores on continuous performance tests (CPTs) in the MM group (P=0.007, 0.02, and 0.01, respectively), and a decrease in plasma TNF-α levels (P=0.04).
LIMITATIONS


The sample size of middle- to old-aged BP-II patients were limited.
CONCLUSION


Add-on MM may attenuate inflammation in BP-II and improve cognition in middle- to old-aged BP-II patients.",2020,"Symptom severity, neuropsychological tests, and the cytokine plasma levels [tumor necrosis factor-α (TNF-α), C-reactive protein (CRP), interleukin-8 (IL-8), transforming growth factor-β1","['155 BP-II patients (23 of which were middle- to old-aged) for the MM group and 170 patients (20 of which were middle- to old-aged) for the placebo group', 'sample size of middle- to old-aged BP-II patients were limited', 'middle- to old-aged bipolar II disorder patients']","['MM or placebo', 'placebo', 'Memantine (MM', 'memantine']","['TGF-β1), and brain-derived neurotrophic factor (BDNF', 'omission T-scores, hit reaction time T-scores, and hit reaction time standard error T-scores on continuous performance tests (CPTs', 'TNF-α levels', 'cognition and inflammation', 'cognitive functions', 'plasma TNF-α levels', 'Symptom severity, neuropsychological tests, and the cytokine plasma levels [tumor necrosis factor-α (TNF-α), C-reactive protein (CRP), interleukin-8 (IL-8), transforming growth factor-β1']","[{'cui': 'C0236788', 'cui_str': 'Bipolar II disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C0439801', 'cui_str': 'Limited'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025242', 'cui_str': 'Memantine'}]","[{'cui': 'C0040691', 'cui_str': 'Transforming Growth Factor'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C0272285', 'cui_str': 'Heparin-induced thrombocytopenia'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0006938', 'cui_str': 'Captopril'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}]",,0.407349,"Symptom severity, neuropsychological tests, and the cytokine plasma levels [tumor necrosis factor-α (TNF-α), C-reactive protein (CRP), interleukin-8 (IL-8), transforming growth factor-β1","[{'ForeName': 'Ru-Band', 'Initials': 'RB', 'LastName': 'Lu', 'Affiliation': 'Department of Psychiatry, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan; Yanjiao Furen Hospital, Hebei, China.'}, {'ForeName': 'Tzu-Yun', 'Initials': 'TY', 'LastName': 'Wang', 'Affiliation': 'Department of Psychiatry, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan. Electronic address: wangty@mail.ncku.edu.tw.'}, {'ForeName': 'Sheng-Yu', 'Initials': 'SY', 'LastName': 'Lee', 'Affiliation': 'Department of Psychiatry, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'Yun-Hsuan', 'Initials': 'YH', 'LastName': 'Chang', 'Affiliation': 'Department of Psychology, Asia University, Taichung, Taiwan; Department of Medical Research, China Medical University Hospital, China Medical University, Taichung, Taiwan.'}, {'ForeName': 'Shiou-Lan', 'Initials': 'SL', 'LastName': 'Chen', 'Affiliation': 'Graduate Institute of Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan; Lipid Science and Aging Research Center, Kaohsiung Medical University, Kaohsiung, Taiwan.'}, {'ForeName': 'Tsung-Yu', 'Initials': 'TY', 'LastName': 'Tsai', 'Affiliation': 'Department of Psychiatry, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Po See', 'Initials': 'PS', 'LastName': 'Chen', 'Affiliation': 'Department of Psychiatry, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan; Institute of Behavioral Medicine, College of Medicine, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'San-Yuan', 'Initials': 'SY', 'LastName': 'Huang', 'Affiliation': 'Department of Psychiatry, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan.'}, {'ForeName': 'Nian-Sheng', 'Initials': 'NS', 'LastName': 'Tzeng', 'Affiliation': 'Department of Psychiatry, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan; Student Counseling Center, National Defense Medical Center, Taipei, Taiwan.'}, {'ForeName': 'I Hui', 'Initials': 'IH', 'LastName': 'Lee', 'Affiliation': 'Department of Psychiatry, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Kao Chin', 'Initials': 'KC', 'LastName': 'Chen', 'Affiliation': 'Department of Psychiatry, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Yen Kuang', 'Initials': 'YK', 'LastName': 'Yang', 'Affiliation': 'Department of Psychiatry, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan; Institute of Behavioral Medicine, College of Medicine, National Cheng Kung University, Tainan, Taiwan; Department of Psychiatry, Tainan Hospital, Ministry of Health and Welfare, Tainan, Taiwan.'}, {'ForeName': 'Jau-Shyong', 'Initials': 'JS', 'LastName': 'Hong', 'Affiliation': 'Neurobiology Laboratory, NIH/NIEHS, Research Triangle Park, NC, USA.'}]",Journal of affective disorders,['10.1016/j.jad.2020.10.003']
1342,33071636,Intrauterine administration of platelet-rich plasma improves embryo implantation by increasing the endometrial thickness in women with repeated implantation failure: A single-arm self-controlled trial.,"Purpose


The purpose of this study was to investigate the effectiveness of intrauterine administration of platelet-rich plasma (PRP) in frozen embryo transfer (FET) cycle in Japanese patients with a thin endometrium.
Method


A prospective single-arm self-controlled trial was conducted in Japan. PRP administration was performed in 36 of the 39 eligible patients with a thin endometrium (≤7 mm). Hormone replacement therapy (HRT) with estrogen was performed for 2 menstrual cycles, and PRP was administrated on the 10th and 12th days of the second HRT cycle. The endometrial thickness was evaluated on transvaginal ultrasonography by two physicians at every visit, one an attending physician and the other a specialist physician blinded to the date and timing of the sonography. FET was performed during the second HRT cycle after PRP administration.
Results


After PRP administration, the mean (SD) endometrial thickness on the 14th day was significantly increased by 1.27 mm ( P  < .001) and 0.72 mm ( P  = .001) on the basis of the unblinded and blinded measurements, respectively. Of the 36 patients, 32 (88.9%) underwent FET. The clinical pregnancy rate was 15.6%. No adverse events occurred.
Conclusions


PRP therapy was safe and effective in increasing endometrial thickness improving possibly pregnancy rate.",2020,"After PRP administration, the mean (SD) endometrial thickness on the 14th day was significantly increased by 1.27 mm ( P  < .001) and 0.72 mm ( P  = .001) on the basis of the unblinded and blinded measurements, respectively.","['Japanese patients with a thin endometrium', 'Japan', 'women with repeated implantation failure', '39 eligible patients with a thin endometrium (≤7\xa0mm']","['platelet-rich plasma (PRP', 'FET', 'PRP', 'Hormone replacement therapy (HRT) with estrogen', 'PRP therapy', 'platelet-rich plasma']","['endometrial thickness', 'adverse events', 'mean (SD) endometrial thickness', 'clinical pregnancy rate']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205168', 'cui_str': 'Thin'}, {'cui': 'C0014180', 'cui_str': 'Endometrial structure'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0231174', 'cui_str': 'Failure'}]","[{'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0404110', 'cui_str': 'Frozen embryo transfer'}, {'cui': 'C0282402', 'cui_str': 'Hormone replacement therapy'}, {'cui': 'C0014939', 'cui_str': 'Estrogens'}, {'cui': 'C4727879', 'cui_str': 'Platelet rich plasma therapy'}]","[{'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}]",39.0,0.0422866,"After PRP administration, the mean (SD) endometrial thickness on the 14th day was significantly increased by 1.27 mm ( P  < .001) and 0.72 mm ( P  = .001) on the basis of the unblinded and blinded measurements, respectively.","[{'ForeName': 'Maki', 'Initials': 'M', 'LastName': 'Kusumi', 'Affiliation': 'Center for Human Reproduction and Gynecologic Endoscopy Sanno Hospital Tokyo Japan.'}, {'ForeName': 'Tatsuji', 'Initials': 'T', 'LastName': 'Ihana', 'Affiliation': 'Center for Human Reproduction and Gynecologic Endoscopy Sanno Hospital Tokyo Japan.'}, {'ForeName': 'Takako', 'Initials': 'T', 'LastName': 'Kurosawa', 'Affiliation': 'Center for Human Reproduction and Gynecologic Endoscopy Sanno Hospital Tokyo Japan.'}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Ohashi', 'Affiliation': 'Department of Integrated Science and Engineering for Sustainable Society Chuo University Tokyo Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Tsutsumi', 'Affiliation': 'Director of Sanno Hospital Tokyo Japan.'}]",Reproductive medicine and biology,['10.1002/rmb2.12334']
1343,33071818,An Intramuscular Injection of Mixed Testosterone Esters Does Not Acutely Enhance Strength and Power in Recreationally Active Young Men.,"Purpose : Limited data are available on the acute performance-enhancing effects of single-dose administration of testosterone in healthy humans. Studies of testosterone administrations to healthy humans are rare due to the difficult nature and necessity of close clinical monitoring. However, our unique physiological experimental facilities combined with close endocrinological collaboration have allowed us to safely complete such a study. We tested the hypothesis that an intramuscular injection of 250 mg mixed testosterone esters (TEs) enhances physical performance in strength and power exercises acutely, measured 24 h after injection. Additionally, we investigated whether the basal serum testosterone concentration influences the performance in countermovement jump (CMJ), 30-s all out cycle sprint, and one-arm isometric elbow flexion.  Methods : In a randomized, double-blind, placebo-controlled design, 19 eugonadal men received either a TE ( n  = 9, 23 ± 1 years, 183 ± 7 cm, 83 ± 10 kg) or a PLA ( n  = 10, 25 ± 2 years, 186 ± 6 cm, 82 ± 14 kg) injection. Hormonal levels and the performance in CMJ, 30-s all out cycle sprint, and one-arm isometric elbow flexion were measured before and 24 h after injection.  Results : Firstly, an intramuscular injection of 250 mg mixed TEs did not enhance the vertical jump height in a CMJ test, peak power, mean power, and fatigue index in a 30-s all-out cycle sprint or rate of force development and maximal voluntary contraction in a one-arm isometric elbow flexion 24 h post-injection. Secondly, baseline testosterone levels appeared not to influence performance in strength and power exercises to a large extent in healthy, recreationally active young men.  Conclusion : A single intramuscular injection of 250 mg mixed TEs has no acute ergogenic effects on strength and power performance in recreationally active, young men. This novel information has implication for basic physiological understanding. Whether the same applies to an elite athlete population remains to be determined. If so, this would have implications for anti-doping efforts aiming to determine the most cost-efficient testing programs.",2020,"A single intramuscular injection of 250 mg mixed TEs has no acute ergogenic effects on strength and power performance in recreationally active, young men.","['19 eugonadal men received either a', 'healthy humans', 'Recreationally Active Young Men', 'recreationally active, young men']","['intramuscular injection of 250 mg mixed TEs', 'testosterone', 'PLA', 'Mixed Testosterone Esters', 'placebo', 'TE', 'intramuscular injection of 250 mg mixed testosterone esters (TEs']","['strength and power performance', 'basal serum testosterone concentration influences the performance in countermovement jump (CMJ), 30-s all out cycle sprint, and one-arm isometric elbow flexion', 'Hormonal levels and the performance in CMJ, 30-s all out cycle sprint, and one-arm isometric elbow flexion', 'vertical jump height in a CMJ test, peak power, mean power, and fatigue index', 'baseline testosterone levels']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C0021492', 'cui_str': 'Intramuscular injection'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0014898', 'cui_str': 'Ester'}, {'cui': 'C0456170', 'cui_str': 'Left atrial pressure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0428413', 'cui_str': 'Serum testosterone measurement'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement'}]",,0.323333,"A single intramuscular injection of 250 mg mixed TEs has no acute ergogenic effects on strength and power performance in recreationally active, young men.","[{'ForeName': 'Sara Amalie', 'Initials': 'SA', 'LastName': 'Solheim', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Mørkeberg', 'Affiliation': 'Anti Doping Denmark, Brøndby, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Juul', 'Affiliation': 'Department of Growth and Reproduction, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Stine Yde', 'Initials': 'SY', 'LastName': 'Freiesleben', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Emmie N', 'Initials': 'EN', 'LastName': 'Upners', 'Affiliation': 'Department of Growth and Reproduction, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Yvette', 'Initials': 'Y', 'LastName': 'Dehnes', 'Affiliation': 'Norwegian Doping Control Laboratory, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Nikolai Baastrup', 'Initials': 'NB', 'LastName': 'Nordsborg', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, Denmark.'}]",Frontiers in physiology,['10.3389/fphys.2020.563620']
1344,33071828,Influence of Shoe Mass on Performance and Running Economy in Trained Runners.,"Purpose


The aim of this study was to assess the effects of adding shoe mass on running economy (RE), gait characteristics, neuromuscular variables and performance in a group of trained runners.
Methods


Eleven trained runners (6 men and 5 women) completed four evaluation sessions separated by at least 7 days. The first session consisted of a maximal incremental test where the second ventilatory threshold (VT 2 ) and the speed associated to the VO 2max  (vVO 2max ) were calculated. In the next sessions, RE at 75, 85, and 95% of the VT 2  and the time to exhaustion (TTE) at vVO 2max  were assessed in three different shoe mass conditions (control, +50 g and +100 g) in a randomized, counterbalanced crossover design. Biomechanical and neuromuscular variables, blood lactate and energy expenditure were measured during the TTE test.
Results


RE worsened with the increment of shoe mass (Control vs. 100 g) at 85% (7.40%, 4.409 ± 0.29 and 4.735 ± 0.27 kJ⋅kg -1 ⋅km -1 ,  p  = 0.021) and 95% (10.21%, 4.298 ± 0.24 and 4.737 ± 0.45 kJ⋅kg -1 ⋅km -1 ,  p  = 0.005) of VT 2 . HR significantly increased with the addition of mass (50 g) at 75% of VT 2  ( p  = 0.01) and at 75, 85, and 95% of VT 2  ( p  = 0.035, 0.03, and 0.03, respectively) with the addition of 100 g. TTE was significantly longer (∼22%, ∼42 s,  p  = 0.002,  ES  = 0.149) in the Control condition vs. 100 g condition, but not between Control vs. 50 g (∼24 s,  p  = 0.094,  ES  = 0.068).
Conclusion


Overall, our findings suggest that adding 100 g per shoe impairs running economy and performance in trained runners without changes in gait characteristics or neuromuscular variables. These findings further support the use of light footwear to optimize running performance.",2020,"HR significantly increased with the addition of mass (50 g) at 75% of VT 2  ( p  = 0.01) and at 75, 85, and 95% of VT 2  ( p  = 0.035, 0.03, and 0.03, respectively) with the addition of 100 g. TTE was significantly longer (∼22%, ∼42 s,  p  = 0.002,  ES  = 0.149) in the Control condition vs. 100 g condition, but not between Control vs. 50 g (∼24 s,  p  = 0.094,  ES  = 0.068).
","['Eleven trained runners (6 men and 5 women', 'a group of trained runners', 'Trained Runners']",[],"['shoe mass', 'gait characteristics or neuromuscular variables', 'Biomechanical and neuromuscular variables, blood lactate and energy expenditure', 'running economy (RE), gait characteristics, neuromuscular variables and performance']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0441835', 'cui_str': 'Group A'}]",[],"[{'cui': 'C0036988', 'cui_str': 'Shoes'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",,0.134929,"HR significantly increased with the addition of mass (50 g) at 75% of VT 2  ( p  = 0.01) and at 75, 85, and 95% of VT 2  ( p  = 0.035, 0.03, and 0.03, respectively) with the addition of 100 g. TTE was significantly longer (∼22%, ∼42 s,  p  = 0.002,  ES  = 0.149) in the Control condition vs. 100 g condition, but not between Control vs. 50 g (∼24 s,  p  = 0.094,  ES  = 0.068).
","[{'ForeName': 'Víctor', 'Initials': 'V', 'LastName': 'Rodrigo-Carranza', 'Affiliation': 'Sport Training Lab, University of Castilla-La Mancha, Toledo, Spain.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'González-Mohíno', 'Affiliation': 'Sport Training Lab, University of Castilla-La Mancha, Toledo, Spain.'}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Santos-Concejero', 'Affiliation': 'Department of Physical Education and Sport, University of the Basque Country UPV/EHU, Vitoria-Gasteiz, Spain.'}, {'ForeName': 'Jose Maria', 'Initials': 'JM', 'LastName': 'González-Ravé', 'Affiliation': 'Sport Training Lab, University of Castilla-La Mancha, Toledo, Spain.'}]",Frontiers in physiology,['10.3389/fphys.2020.573660']
1345,32675229,Safety decision-making and planning mobile app for intimate partner violence prevention and response: randomised controlled trial in Kenya.,"INTRODUCTION


Intimate partner violence (IPV) threatens women's health and safety globally, yet services remain underdeveloped and inaccessible. Technology-based resources exist, however, few have been adapted and tested in low-resource settings. We evaluate the efficacy of a community-partnered technology solution: culturally and linguistically adapted version of the myPlan app, a tailored safety decision-making and planning intervention, administrated by trained lay professionals.
METHODS


This randomised, controlled, participant-blinded superiority trial compares safety-related outcomes at baseline, immediate post intervention and 3-month follow-up among women at risk of and experiencing IPV in Nairobi, Kenya. Women were randomised (1:1 ratio) to: (1) myPlan Kenya (intervention); or (2) standard IPV referrals (control). Primary outcomes were safety preparedness, safety behaviour and IPV; secondary outcomes include resilience, mental health, service utilisation and self-blame.
RESULTS


Between April 2018 and October 2018, 352 participants (n=177 intervention, n=175 control) were enrolled and randomly assigned; 312 (88.6%, n=157 intervention, n=155 control) were retained at 3 months. Intervention participants demonstrated immediate postintervention improvement in safety preparedness relative to control participants (p=0.001). At 3 months, intervention participants reported increased helpfulness of safety strategies used relative to control participants (p=0.004); IPV reduced in both groups. Among women reporting the highest level of IPV severity, intervention participants had significant increase in resilience (p<0.01) compared with controls, and significantly decreased risk for lethal violence (p<0.01).
CONCLUSIONS


Facilitated delivery of a technology-based safety intervention appropriately adapted to the context demonstrates promise in improving women's IPV-related health and safety in a low-resource, urban setting.
TRIAL REGISTRATION NUMBER


Pan African Clinical Trial Registry (PACTR201804003321122).",2020,Intervention participants demonstrated immediate postintervention improvement in safety preparedness relative to control participants (p=0.001).,"['women at risk of and experiencing IPV in Nairobi, Kenya', 'Between April 2018 and October 2018, 352 participants (n=177 intervention, n=175 control) were enrolled and randomly assigned; 312 (88.6%, n=157 intervention, n=155 control']","['community-partnered technology solution', 'myPlan Kenya (intervention); or (2) standard IPV referrals (control']","['immediate postintervention improvement in safety preparedness', 'risk for lethal violence', 'IPV', 'safety preparedness, safety behaviour and IPV; secondary outcomes include resilience, mental health, service utilisation and self-blame', 'helpfulness of safety strategies']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0027345', 'cui_str': 'Nairobi sheep virus disease'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C4517706', 'cui_str': '312'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C1321226', 'cui_str': 'Safety behavior'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0018379', 'cui_str': 'Feeling guilt'}]",,0.174925,Intervention participants demonstrated immediate postintervention improvement in safety preparedness relative to control participants (p=0.001).,"[{'ForeName': 'Michele R', 'Initials': 'MR', 'LastName': 'Decker', 'Affiliation': 'Population, Family and Reproductive Health, Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland, USA mdecker@jhu.edu.'}, {'ForeName': 'Shannon N', 'Initials': 'SN', 'LastName': 'Wood', 'Affiliation': 'Population, Family and Reproductive Health, Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'Zaynab', 'Initials': 'Z', 'LastName': 'Hameeduddin', 'Affiliation': 'Population, Family and Reproductive Health, Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'S Rachel', 'Initials': 'SR', 'LastName': 'Kennedy', 'Affiliation': 'Johns Hopkins University School of Nursing, Baltimore, Maryland, USA.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Perrin', 'Affiliation': 'Johns Hopkins University School of Nursing, Baltimore, Maryland, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Tallam', 'Affiliation': 'Ujamaa Africa, Nairobi, Kenya.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Akumu', 'Affiliation': 'Ujamaa Africa, Nairobi, Kenya.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Wanjiru', 'Affiliation': 'Ujamaa Africa, Nairobi, Kenya.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Asira', 'Affiliation': 'Ujamaa Africa, Nairobi, Kenya.'}, {'ForeName': 'Ariel', 'Initials': 'A', 'LastName': 'Frankel', 'Affiliation': 'International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Omondi', 'Affiliation': 'Ujamaa Africa, Nairobi, Kenya.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Case', 'Affiliation': 'Johns Hopkins University School of Nursing, Baltimore, Maryland, USA.'}, {'ForeName': 'Amber', 'Initials': 'A', 'LastName': 'Clough', 'Affiliation': 'Johns Hopkins University School of Nursing, Baltimore, Maryland, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Otieno', 'Affiliation': 'Ujamaa Africa, Nairobi, Kenya.'}, {'ForeName': 'Morris', 'Initials': 'M', 'LastName': 'Mwiti', 'Affiliation': 'Ujamaa Africa, Nairobi, Kenya.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Glass', 'Affiliation': 'Johns Hopkins University School of Nursing, Baltimore, Maryland, USA.'}]",BMJ global health,['10.1136/bmjgh-2019-002091']
1346,32675261,"Effects of Implementing a Comprehensive Opioid Reduction Protocol on Overall Opioid Prescribing Among Patients with Chronic, Non-Cancer Pain in a Rural Family Medicine Clinic: A Controlled Cross-over Trial.","BACKGROUND


The opioid crisis presents many challenges for family practice providers in rural communities who treat patients with chronic non-cancer pain (CNCP). Unfortunately, evidence for effective opioid reduction strategies is sparse. We evaluated the effects of implementing a comprehensive opioid reduction protocol on overall opioid prescribing among patients with chronic non-cancer pain in our rural family medicine clinics.
METHODS


We compared mean daily milligrams morphine equivalent (MME) prescribed to patients with CNCP in our rural family medicine clinic (n = 93) with another matched clinic (n =93) after implementation of our comprehensive protocol. We also compared mean daily MME prescribed to our patients with CNCP before and after implementation of the protocol. In a subsequent cross over phase, we examined the effects of the protocol when applied to the original control group patients.
RESULTS


Mean daily MME in the intervention clinic (29.77) was significantly lower than the control clinic (93.2) after the intervention (t = 6.03;  P  < .00). Mean daily MME in the intervention group was significantly lower after implementation of the protocol (29.77) than before the protocol (MME 80.34) (t = 5.889;  P  < .00). After crossover, the mean daily MME was significantly lower (14.34) in the original control group than prior to the cross over intervention (85.68); (t = 8.19;  P  = .00).
DISCUSSION


Our comprehensive opioid reduction protocol led to significant reductions in opioid prescribing in our rural family medicine clinics. Future studies should include important qualitative outcome measures such as patient function.",2020,Mean daily MME in the intervention group was significantly lower after implementation of the protocol (29.77) than before the protocol (MME 80.34) (t = 5.889;  P  < .00).,"['rural communities who treat patients with chronic non-cancer pain (CNCP', 'patients with chronic non-cancer pain in our rural family medicine clinics', 'patients with CNCP in our rural family medicine clinic (n = 93) with another matched clinic (n =93) after implementation of our comprehensive protocol', 'Patients with Chronic, Non-Cancer Pain in a Rural Family Medicine Clinic']","['morphine equivalent (MME', 'comprehensive opioid reduction protocol', 'Comprehensive Opioid Reduction Protocol']","['mean daily MME', 'Mean daily MME', 'Overall Opioid Prescribing']","[{'cui': 'C0086944', 'cui_str': 'Rural Communities'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0596240', 'cui_str': 'Cancer pain'}, {'cui': 'C3833703', 'cui_str': 'Family medicine clinic'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0439210', 'cui_str': 'mg'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439210', 'cui_str': 'mg'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}]",93.0,0.016234,Mean daily MME in the intervention group was significantly lower after implementation of the protocol (29.77) than before the protocol (MME 80.34) (t = 5.889;  P  < .00).,"[{'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Stack', 'Affiliation': 'Michigan State University/MidMichigan Medical Center-Gratiot Family Medicine Residency Program, Alma. matthew.stack@midmichigan.org.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'LaRouche', 'Affiliation': 'Michigan State University/MidMichigan Medical Center-Gratiot Family Medicine Residency Program, Alma.'}, {'ForeName': 'Yezi', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Michigan State University/MidMichigan Medical Center-Gratiot Family Medicine Residency Program, Alma.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Warden', 'Affiliation': 'Michigan State University/MidMichigan Medical Center-Gratiot Family Medicine Residency Program, Alma.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Stack', 'Affiliation': 'Michigan State University/MidMichigan Medical Center-Gratiot Family Medicine Residency Program, Alma.'}, {'ForeName': 'Egle A', 'Initials': 'EA', 'LastName': 'Klugiene', 'Affiliation': 'Michigan State University/MidMichigan Medical Center-Gratiot Family Medicine Residency Program, Alma.'}]",Journal of the American Board of Family Medicine : JABFM,['10.3122/jabfm.2020.04.200060']
1347,32673262,Implementing mHealth Interventions in a Resource-Constrained Setting: Case Study From Uganda.,"BACKGROUND


Mobile health (mHealth) interventions are becoming more common in low-income countries. Existing research often overlooks implementation challenges associated with the design and technology requirements of mHealth interventions.
OBJECTIVE


We aimed to characterize the challenges that we encountered in the implementation of a complex mHealth intervention in Uganda.
METHODS


We customized a commercial mobile survey app to facilitate a two-arm household-randomized, controlled trial of home-based tuberculosis (TB) contact investigation. We incorporated digital fingerprinting for patient identification in both study arms and automated SMS messages in the intervention arm only. A local research team systematically documented challenges to implementation in biweekly site visit reports, project management reports, and minutes from biweekly conference calls. We then classified these challenges using the Consolidated Framework for Implementation Research (CFIR).
RESULTS


We identified challenges in three principal CFIR domains: (1) intervention characteristics, (2) inner setting, and (3) characteristics of implementers. The adaptability of the app to the local setting was limited by software and hardware requirements. The complexity and logistics of implementing the intervention further hindered its adaptability. Study staff reported that community health workers (CHWs) were enthusiastic regarding the use of technology to enhance TB contact investigation during training and the initial phase of implementation. After experiencing technological failures, their trust in the technology declined along with their use of it. Finally, complex data structures impeded the development and execution of a data management plan that would allow for articulation of goals and provide timely feedback to study staff, CHWs, and participants.
CONCLUSIONS


mHealth technologies have the potential to make delivery of public health interventions more direct and efficient, but we found that a lack of adaptability, excessive complexity, loss of trust among end users, and a lack of effective feedback systems can undermine implementation, especially in low-resource settings where digital services have not yet proliferated. Implementers should anticipate and strive to avoid these barriers by investing in and adapting to local human and material resources, prioritizing feedback from end users, and optimizing data management and quality assurance procedures.
TRIAL REGISTRATION


Pan-African Clinical Trials Registration PACTR201509000877140; https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=877.",2020,Study staff reported that community health workers (CHWs) were enthusiastic regarding the use of technology to enhance TB contact investigation during training and the initial phase of implementation.,"['community health workers (CHWs', 'We customized a commercial mobile survey app to facilitate a two-arm household-randomized, controlled trial of home-based tuberculosis (TB) contact investigation', 'Uganda']",[],[],"[{'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C1261322', 'cui_str': 'Evaluation procedure'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}]",[],[],,0.074366,Study staff reported that community health workers (CHWs) were enthusiastic regarding the use of technology to enhance TB contact investigation during training and the initial phase of implementation.,"[{'ForeName': 'Amanda J', 'Initials': 'AJ', 'LastName': 'Meyer', 'Affiliation': 'Department of Epidemiology of Microbial Diseases, Yale School of Public Health, New Haven, CT, United States.'}, {'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Armstrong-Hough', 'Affiliation': 'Uganda Tuberculosis Implementation Research Consortium, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Babirye', 'Affiliation': 'Uganda Tuberculosis Implementation Research Consortium, Makerere University, Kampala, Uganda.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Mark', 'Affiliation': 'Uganda Tuberculosis Implementation Research Consortium, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Turimumahoro', 'Affiliation': 'Uganda Tuberculosis Implementation Research Consortium, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Ayakaka', 'Affiliation': 'Uganda Tuberculosis Implementation Research Consortium, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Jessica E', 'Initials': 'JE', 'LastName': 'Haberer', 'Affiliation': 'Massachusetts General Hospital and Harvard Medical School, Boston, MA, United States.'}, {'ForeName': 'Achilles', 'Initials': 'A', 'LastName': 'Katamba', 'Affiliation': 'Uganda Tuberculosis Implementation Research Consortium, Makerere University, Kampala, Uganda.'}, {'ForeName': 'J Lucian', 'Initials': 'JL', 'LastName': 'Davis', 'Affiliation': 'Department of Epidemiology of Microbial Diseases, Yale School of Public Health, New Haven, CT, United States.'}]",JMIR mHealth and uHealth,['10.2196/19552']
1348,32681134,Stimulus modality influences session-to-session transfer of training effects in auditory and tactile streaming-based P300 brain-computer interfaces.,"Despite recent successes, patients suffering from locked-in syndrome (LIS) still struggle to communicate using vision-independent brain-computer interfaces (BCIs). In this study, we compared auditory and tactile BCIs, regarding training effects and cross-stimulus-modality transfer effects, when switching between stimulus modalities. We utilized a streaming-based P300 BCI, which was developed as a low workload approach to prevent potential BCI-inefficiency. We randomly assigned 20 healthy participants to two groups. The participants received three sessions of training either using an auditory BCI or using a tactile BCI. In an additional fourth session, BCI versions were switched to explore possible cross-stimulus-modality transfer effects. Both BCI versions could be operated successfully in the first session by the majority of the participants, with the tactile BCI being experienced as more intuitive. Significant training effects were found mostly in the auditory BCI group and strong evidence for a cross-stimulus-modality transfer occurred for the auditory training group that switched to the tactile version but not vice versa. All participants were able to control at least one BCI version, suggesting that the investigated paradigms are generally feasible and merit further research into their applicability with LIS end-users. Individual preferences regarding stimulus modality should be considered.",2020,Significant training effects were found mostly in the auditory BCI group and strong evidence for a cross-stimulus-modality transfer occurred for the auditory training group that switched to the tactile version but not vice versa.,['20 healthy participants to two groups'],"['training either using an auditory BCI or using a tactile BCI', 'auditory training']",[],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C2742590', 'cui_str': '2-benzylidene-3-(cyclohexylamino)-2,3-dihydro-1H-inden-1-one'}, {'cui': 'C0439815', 'cui_str': 'Tactile'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]",[],20.0,0.0239414,Significant training effects were found mostly in the auditory BCI group and strong evidence for a cross-stimulus-modality transfer occurred for the auditory training group that switched to the tactile version but not vice versa.,"[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Ziebell', 'Affiliation': 'Institute of Psychology, University of Würzburg, Würzburg, Germany. philipp.ziebell@uni-wuerzburg.de.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Stümpfig', 'Affiliation': 'Institute of Psychology, University of Würzburg, Würzburg, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Eidel', 'Affiliation': 'Institute of Psychology, University of Würzburg, Würzburg, Germany.'}, {'ForeName': 'S C', 'Initials': 'SC', 'LastName': 'Kleih', 'Affiliation': 'Institute of Psychology, University of Würzburg, Würzburg, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kübler', 'Affiliation': 'Institute of Psychology, University of Würzburg, Würzburg, Germany.'}, {'ForeName': 'M E', 'Initials': 'ME', 'LastName': 'Latoschik', 'Affiliation': 'Institute of Computer Science, University of Würzburg, Würzburg, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Halder', 'Affiliation': 'School of Computer Science and Electronic Engineering (CSEE), University of Essex, Colchester, UK.'}]",Scientific reports,['10.1038/s41598-020-67887-6']
1349,33065840,Strategies for augmentation of high-frequency left-sided repetitive transcranial magnetic stimulation treatment of major depressive disorder.,"BACKGROUND


Repetitive Transcranial Magnetic Stimulation (rTMS) is an effective intervention for treatment-resistant Major Depressive Disorder (MDD). Early improvement during high-frequency left-sided (HFL) stimulation of the dorsolateral prefrontal cortex (DLPFC) is an important predictor of longer-term outcome, but most patients benefit later in their treatment course. We examined patients without early improvement with HFL to determine whether augmentation with additional stimulation approaches improved treatment outcome.
METHODS


139 participants received HFL in a measurement-based care paradigm. Participants who achieved < 20% improvement by treatment 10 could continue with HFL (N = 17) or receive one of two augmentation strategies: bilateral stimulation (BL; HFL followed by low-frequency stimulation of right DLPFC) (N = 69) or intermittent theta-burst priming of left DLPFC (iTBS-P) (N = 17) for their remaining treatment sessions. The primary outcome was the percent reduction in depressive symptoms at treatment 30.
RESULTS


Participants who achieved < 20% improvement by treatment 10 and continued with HFL showed limited benefit. iTBS-P participants had significantly greater improvement, while those receiving BL trended toward improved outcomes. Ten sessions of either augmentation strategy appeared necessary to determine the likelihood of benefit.
CONCLUSIONS


Augmentation of early non-response to HFL appears to improve rTMS outcomes, with a novel iTBS-P strategy surpassing both continued HFL or BL treatment in participants with < 20% improvement after 10 treatments. These findings suggest that measurement-based care with addition of augmented stimulation for those not showing early improvement may yield superior rTMS treatment outcomes.",2020,"iTBS-P participants had significantly greater improvement, while those receiving BL trended toward improved outcomes.","['major depressive disorder', '139 participants received', 'Participants who achieved < 20% improvement by treatment 10 could continue with HFL (N\xa0=\xa017) or receive one of two']","['repetitive transcranial magnetic stimulation treatment', 'intermittent theta-burst priming of left DLPFC (iTBS-P', 'augmentation strategies: bilateral stimulation (BL; HFL followed by low-frequency stimulation of right DLPFC', 'Repetitive Transcranial Magnetic Stimulation (rTMS', 'HFL in a measurement-based care paradigm']","['rTMS outcomes', 'depressive symptoms']","[{'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0205091', 'cui_str': 'Left'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C0331021', 'cui_str': 'Ligustrum vulgare'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",139.0,0.0501479,"iTBS-P participants had significantly greater improvement, while those receiving BL trended toward improved outcomes.","[{'ForeName': 'Jonathan C', 'Initials': 'JC', 'LastName': 'Lee', 'Affiliation': 'TMS Clinical and Research Service, Neuromodulation Division, Semel Institute for Neuroscience and Human Behavior, and the Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine at UCLA, 760 Westwood Plaza, Los Angeles, CA 90024, United States.. Electronic address: JonathanCLee@mednet.ucla.edu.'}, {'ForeName': 'Andrew C', 'Initials': 'AC', 'LastName': 'Wilson', 'Affiliation': 'TMS Clinical and Research Service, Neuromodulation Division, Semel Institute for Neuroscience and Human Behavior, and the Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine at UCLA, 760 Westwood Plaza, Los Angeles, CA 90024, United States.'}, {'ForeName': 'Juliana', 'Initials': 'J', 'LastName': 'Corlier', 'Affiliation': 'TMS Clinical and Research Service, Neuromodulation Division, Semel Institute for Neuroscience and Human Behavior, and the Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine at UCLA, 760 Westwood Plaza, Los Angeles, CA 90024, United States.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Tadayonnejad', 'Affiliation': 'TMS Clinical and Research Service, Neuromodulation Division, Semel Institute for Neuroscience and Human Behavior, and the Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine at UCLA, 760 Westwood Plaza, Los Angeles, CA 90024, United States.; California Institute of Technology, Division of the Humanities and Social Sciences, 1200 E California Blvd, Pasadena, CA, 91125, United States.'}, {'ForeName': 'Katharine G', 'Initials': 'KG', 'LastName': 'Marder', 'Affiliation': 'TMS Clinical and Research Service, Neuromodulation Division, Semel Institute for Neuroscience and Human Behavior, and the Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine at UCLA, 760 Westwood Plaza, Los Angeles, CA 90024, United States.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Pleman', 'Affiliation': 'TMS Clinical and Research Service, Neuromodulation Division, Semel Institute for Neuroscience and Human Behavior, and the Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine at UCLA, 760 Westwood Plaza, Los Angeles, CA 90024, United States.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Krantz', 'Affiliation': 'TMS Clinical and Research Service, Neuromodulation Division, Semel Institute for Neuroscience and Human Behavior, and the Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine at UCLA, 760 Westwood Plaza, Los Angeles, CA 90024, United States.'}, {'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'Wilke', 'Affiliation': 'TMS Clinical and Research Service, Neuromodulation Division, Semel Institute for Neuroscience and Human Behavior, and the Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine at UCLA, 760 Westwood Plaza, Los Angeles, CA 90024, United States.'}, {'ForeName': 'Jennifer G', 'Initials': 'JG', 'LastName': 'Levitt', 'Affiliation': 'TMS Clinical and Research Service, Neuromodulation Division, Semel Institute for Neuroscience and Human Behavior, and the Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine at UCLA, 760 Westwood Plaza, Los Angeles, CA 90024, United States.'}, {'ForeName': 'Nathaniel D', 'Initials': 'ND', 'LastName': 'Ginder', 'Affiliation': 'TMS Clinical and Research Service, Neuromodulation Division, Semel Institute for Neuroscience and Human Behavior, and the Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine at UCLA, 760 Westwood Plaza, Los Angeles, CA 90024, United States.; VA Greater Los Angeles Healthcare System, 11301 Wilshire Blvd, Los Angeles, CA 90073, United States.'}, {'ForeName': 'Andrew F', 'Initials': 'AF', 'LastName': 'Leuchter', 'Affiliation': 'TMS Clinical and Research Service, Neuromodulation Division, Semel Institute for Neuroscience and Human Behavior, and the Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine at UCLA, 760 Westwood Plaza, Los Angeles, CA 90024, United States.'}]",Journal of affective disorders,['10.1016/j.jad.2020.09.011']
1350,33065952,"Comparing Injectable DaxibotulinumtoxinA and OnabotulinumtoxinA in Moderate and Severe Glabellar Lines: Additional Analyses From a Phase 2, Randomized, Dose-Ranging, Double-Blind, Multicenter Study.","BACKGROUND


Injectable daxibotulinumtoxinA (RT002) is an investigational botulinum toxin Type A. Published Phase 2 data show that, compared with 20U onabotulinumtoxinA, 40U daxibotulinumtoxinA is associated with a significantly greater response rate and significantly longer duration of response (median 24 weeks), and appears generally safe and well tolerated (www.clinicaltrials.gov NCT02303002).
OBJECTIVE


To evaluate whether these efficacy and safety findings are influenced by baseline glabellar line severity.
MATERIALS AND METHODS


In the Phase 2, randomized, dose-ranging, parallel-group, double-blind, multicenter study, subjects with moderate or severe glabellar lines at maximum frown were randomly assigned to 20U, 40U, or 60U daxibotulinumtoxinA, 20U onabotulinumtoxinA, or placebo. Efficacy was evaluated by investigators for ≥24 weeks.
RESULTS


Data from the per protocol population (n = 191) stratified by baseline glabellar line severity (125 moderate, 66 severe) suggest that the clinical advantage of 40U daxibotulinumtoxinA over 20U onabotulinumtoxinA is maintained for a range of efficacy outcomes regardless of whether glabellar lines are moderate or severe at baseline. Statistical evaluations were not completed due to the limited size of each subgroup.
CONCLUSION


40U daxibotulinumtoxinA appears to offer a clinical efficacy advantage over 20U onabotulinumtoxinA in both moderate and severe glabellar lines-with a greater advantage observed in severe glabellar lines.",2017,40U daxibotulinumtoxinA appears to offer a clinical efficacy advantage over 20U onabotulinumtoxinA in both moderate and severe glabellar lines-with a greater advantage observed in severe glabellar lines.,"['Data from the per protocol population (n = 191) stratified by baseline glabellar line severity (125 moderate, 66 severe', 'Moderate and Severe Glabellar Lines', 'subjects with moderate or severe glabellar lines at maximum frown']","['Injectable DaxibotulinumtoxinA and OnabotulinumtoxinA', 'daxibotulinumtoxinA (RT002', 'daxibotulinumtoxinA, 20U onabotulinumtoxinA, or placebo']","['Efficacy', 'safe and well tolerated']","[{'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0442019', 'cui_str': 'Glabellar'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0806909', 'cui_str': 'Max'}]","[{'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C2719767', 'cui_str': 'OnabotulinumtoxinA'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",191.0,0.432342,40U daxibotulinumtoxinA appears to offer a clinical efficacy advantage over 20U onabotulinumtoxinA in both moderate and severe glabellar lines-with a greater advantage observed in severe glabellar lines.,"[{'ForeName': 'Vince', 'Initials': 'V', 'LastName': 'Bertucci', 'Affiliation': '*Division of Dermatology, University of Toronto, Toronto, Ontario, Canada; Departments of †Dermatology and Skin Science, and ‡Ophthalmology and Visual Sciences, University of British Columbia, Vancouver, British Columbia, Canada; §Faculty of Medicine, McMaster University, Hamilton, Ontario, Canada; ‖Dermetics, Burlington, Ontario, Canada; ¶The Westmount Institute of Plastic Surgery, Montreal, Québec, Canada; #Clinical Development Department, Revance Therapeutics, Inc., Newark, California; **Write on Target Ltd., Leighton Buzzard, United Kingdom.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Humphrey', 'Affiliation': ''}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Carruthers', 'Affiliation': ''}, {'ForeName': 'Nowell', 'Initials': 'N', 'LastName': 'Solish', 'Affiliation': ''}, {'ForeName': 'Channy', 'Initials': 'C', 'LastName': 'Muhn', 'Affiliation': ''}, {'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'Swift', 'Affiliation': ''}, {'ForeName': 'Roman G', 'Initials': 'RG', 'LastName': 'Rubio', 'Affiliation': ''}, {'ForeName': 'Gill', 'Initials': 'G', 'LastName': 'Shears', 'Affiliation': ''}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Rosen', 'Affiliation': ''}]",Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.],['10.1097/DSS.0000000000001364']
1351,33065953,Forehead Line Treatment With OnabotulinumtoxinA in Subjects With Forehead and Glabellar Facial Rhytids: A Phase 3 Study.,"BACKGROUND


Effacement of horizontal forehead lines (FHL) with onabotulinumtoxinA has not been investigated in prospective Phase 3 studies.
OBJECTIVE


To evaluate safety and efficacy of onabotulinumtoxinA treatment of FHL together with glabellar lines (GL).
MATERIALS AND METHODS


A 12-month, Phase 3 study randomized subjects with moderate-to-severe FHL and GL to onabotulinumtoxinA 40 U or placebo, distributed between the frontalis (20 U) and glabellar complex (20 U). After Day 180, subjects could receive up to 2 additional open-label onabotulinumtoxinA treatments. Efficacy was assessed using the Facial Wrinkle Scale (FWS) and Facial Line Outcomes questionnaire.
RESULTS


The intent-to-treat (ITT) population included 391 subjects, and the modified ITT (mITT) population (subjects with psychological impact) included 254 subjects. After 30 days, onabotulinumtoxinA significantly improved the investigator- and subject-assessed appearance of FHL severity by at least 2 FWS grades in 61.4% of ITT subjects versus 0% of placebo subjects (p < .0001). In the mITT population, 94.8% of onabotulinumtoxinA subjects and 1.7% of placebo subjects achieved investigator- and subject-assessed FWS ratings of none/mild (p = .0003). Patient-reported outcomes were consistent with FWS ratings. OnabotulinumtoxinA was well tolerated.
CONCLUSION


OnabotulinumtoxinA 40 U distributed between the frontalis and glabellar complex was safe and effective for treatment of moderate-to-severe FHL.",2017,"After 30 days, onabotulinumtoxinA significantly improved the investigator- and subject-assessed appearance of FHL severity by at least 2 FWS grades in 61.4% of ITT subjects versus 0% of placebo subjects (p < .0001).","['A 12-month, Phase 3 study randomized subjects with moderate-to-severe FHL and GL to onabotulinumtoxinA 40 U or placebo, distributed between the frontalis (20 U) and glabellar complex (20 U', '391 subjects, and the modified ITT (mITT) population (subjects with psychological impact) included 254 subjects', 'Subjects With Forehead and Glabellar Facial Rhytids']","['onabotulinumtoxinA', 'placebo', 'FHL together with glabellar lines (GL', 'Forehead Line Treatment With OnabotulinumtoxinA', 'OnabotulinumtoxinA', 'horizontal forehead lines (FHL) with onabotulinumtoxinA']","['Facial Wrinkle Scale (FWS) and Facial Line Outcomes questionnaire', 'Efficacy', 'investigator- and subject-assessed FWS ratings', 'investigator- and subject-assessed appearance of FHL severity']","[{'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0016540', 'cui_str': 'Forehead structure'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0442019', 'cui_str': 'Glabellar'}, {'cui': 'C2719767', 'cui_str': 'OnabotulinumtoxinA'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}]","[{'cui': 'C2719767', 'cui_str': 'OnabotulinumtoxinA'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0016540', 'cui_str': 'Forehead structure'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0442019', 'cui_str': 'Glabellar'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}]","[{'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0037301', 'cui_str': 'Wrinkled skin'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0016540', 'cui_str': 'Forehead structure'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",391.0,0.0339966,"After 30 days, onabotulinumtoxinA significantly improved the investigator- and subject-assessed appearance of FHL severity by at least 2 FWS grades in 61.4% of ITT subjects versus 0% of placebo subjects (p < .0001).","[{'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Fagien', 'Affiliation': '*Aesthetic Eyelid Plastic Surgery, Boca Raton, Florida; †AboutSkin Dermatology and DermSurgery, Greenwood Village, Colorado; ‡Coleman Center for Cosmetic Dermatologic Surgery, Metairie, Louisiana; §Total Skin and Beauty Dermatology Center, Birmingham, Alabama; ‖Department of Ophthalmology and Visual Sciences, University of British Columbia, Vancouver, British Columbia, Canada; ¶Peloton Advantage, Parsippany, New Jersey; #Allergan plc, Irvine, California.'}, {'ForeName': 'Joel L', 'Initials': 'JL', 'LastName': 'Cohen', 'Affiliation': ''}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Coleman', 'Affiliation': ''}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Monheit', 'Affiliation': ''}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Carruthers', 'Affiliation': ''}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Street', 'Affiliation': ''}, {'ForeName': 'Kristin E', 'Initials': 'KE', 'LastName': 'Larsen', 'Affiliation': ''}, {'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Yushmanova', 'Affiliation': ''}, {'ForeName': 'Xiaofang', 'Initials': 'X', 'LastName': 'Lei', 'Affiliation': ''}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Domenico', 'Initials': 'D', 'LastName': 'Vitarella', 'Affiliation': ''}, {'ForeName': 'Cheri', 'Initials': 'C', 'LastName': 'Mao', 'Affiliation': ''}]",Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.],['10.1097/DSS.0000000000001414']
1352,33065954,IncobotulinumtoxinA Is an Effective and Well-Tolerated Treatment for Upper Facial Lines: Results From an Open-Label Extension Period of a Phase III Study.,"BACKGROUND


In clinical practice, different upper facial areas are commonly treated together.
OBJECTIVE


To evaluate the efficacy and safety of repeated incobotulinumtoxinA injections for the treatment of upper facial lines (UFL) in a 3-month open-label extension (OLEX) period.
MATERIALS AND METHODS


In the main study period (randomized, double blind, placebo controlled; n = 156), subjects with moderate-to-severe UFL (glabellar frown lines [GFL], horizontal forehead lines [HFL], and lateral periorbital lines [LPL]) on the 5-point Merz Aesthetics Scales (MAS) received 54 to 64 U incobotulinumtoxinA or placebo. In the OLEX, all subjects (n = 139) received 1 treatment with 54 to 64 U incobotulinumtoxinA. Investigator- and subject-assessed MAS scores were evaluated at rest and maximum contraction. Response was defined either as a MAS score of ""none"" or ""mild"" or a ≥1-point improvement in MAS scores.
RESULTS


A clear, rapid treatment response was seen in each individual treated area and for all areas combined. At Day 30, a response of none or mild at maximum contraction (investigator's rating) was reported for 80.1%, 77.2%, and 66.9% of subjects for GFL, HFL, and LPL, respectively. IncobotulinumtoxinA was well tolerated, with no evidence of an increase in adverse events with repeat injection.
CONCLUSION


IncobotulinumtoxinA is highly effective for the simultaneous treatment of UFL with a good safety profile (EudraCT Number: 2011-005887-20).",2017,"IncobotulinumtoxinA was well tolerated, with no evidence of an increase in adverse events with repeat injection.
","['subjects with moderate-to-severe UFL (glabellar frown lines [GFL], horizontal forehead lines [HFL], and lateral periorbital lines [LPL]) on the 5-point Merz Aesthetics Scales (MAS) received 54 to 64 U', 'Upper Facial Lines']","['incobotulinumtoxinA injections', 'placebo', 'IncobotulinumtoxinA', 'incobotulinumtoxinA or placebo']","['efficacy and safety', 'adverse events', ""response of none or mild at maximum contraction (investigator's rating"", 'MAS scores']","[{'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0948887', 'cui_str': 'Glabellar frown lines'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0016540', 'cui_str': 'Forehead structure'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0230064', 'cui_str': 'Periorbital'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]","[{'cui': 'C2930113', 'cui_str': 'IncobotulinumtoxinA'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0961667,"IncobotulinumtoxinA was well tolerated, with no evidence of an increase in adverse events with repeat injection.
","[{'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Trevidic', 'Affiliation': '*Expert2Expert, Paris, France; †Regency Medical Clinic, Glasgow, United Kingdom; ‡Private Practice for Skin Diseases, Allergology and Aesthetic Dermatology, Ludwigshafen, Germany; §Merz Pharmaceuticals GmbH, Frankfurt am Main, Germany; ‖Ogilvy Healthworld, Oxford, United Kingdom; ¶Clinique Esthétique St George, Nice, France; #Department for Plastic, Reconstructive and Aesthetic Surgery, Red Cross Hospital, Kassel, Germany; **Rosenparkklinik, Darmstadt, Germany; and ††Division of Cosmetic Science, University of Hamburg, Hamburg, Germany.'}, {'ForeName': 'Simon A', 'Initials': 'SA', 'LastName': 'Connolly', 'Affiliation': ''}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Biwer', 'Affiliation': ''}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Ellers-Lenz', 'Affiliation': ''}, {'ForeName': 'Laura S', 'Initials': 'LS', 'LastName': 'Harrington', 'Affiliation': ''}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Kestemont', 'Affiliation': ''}, {'ForeName': 'Ernst M', 'Initials': 'EM', 'LastName': 'Noah', 'Affiliation': ''}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Sattler', 'Affiliation': ''}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Weissenberger', 'Affiliation': ''}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Kerscher', 'Affiliation': ''}]",Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.],['10.1097/DSS.0000000000001416']
1353,33066761,"A parallel-group, multicenter randomized, double-blinded, placebo-controlled, phase 2/3, clinical trial to test the efficacy of pyridostigmine bromide at low doses to reduce mortality or invasive mechanical ventilation in adults with severe SARS-CoV-2 infection: the Pyridostigmine In Severe COvid-19 (PISCO) trial protocol.","BACKGROUND


Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, the causative agent of coronavirus disease 2019 (COVID-19), may lead to severe systemic inflammatory response, pulmonary damage, and even acute respiratory distress syndrome (ARDS). This in turn may result in respiratory failure and in death. Experimentally, acetylcholine (ACh) modulates the acute inflammatory response, a neuro-immune mechanism known as the inflammatory reflex. Recent clinical evidence suggest that electrical and chemical stimulation of the inflammatory reflex may reduce the burden of inflammation in chronic inflammatory diseases. Pyridostigmine (PDG), an ACh-esterase inhibitor (i-ACh-e), increases the half-life of endogenous ACh, therefore mimicking the inflammatory reflex. This clinical trial is aimed at evaluating if add-on of PDG leads to a decrease of invasive mechanical ventilation and death among patients with severe COVID-19.
METHODS


A parallel-group, multicenter, randomized, double-blinded, placebo-controlled, phase 2/3 clinical trial to test the efficacy of pyridostigmine bromide 60 mg/day P.O. to reduce the need for invasive mechanical ventilation and mortality in hospitalized patients with severe COVID-19.
DISCUSSION


This study will provide preliminary evidence of whether or not -by decreasing systemic inflammation- add-on PDG can improve clinical outcomes in patients with severe COVID-19.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04343963 (registered on April 14, 2020).",2020,"This study will provide preliminary evidence of whether or not -by decreasing systemic inflammation- add-on PDG can improve clinical outcomes in patients with severe COVID-19.
","['Severe acute respiratory syndrome coronavirus 2', 'patients with severe COVID-19', 'hospitalized patients with severe COVID-19', 'adults with severe SARS-CoV-2 infection']","['acetylcholine (ACh', 'Pyridostigmine', 'pyridostigmine bromide', 'placebo', 'Pyridostigmine (PDG']","['invasive mechanical ventilation and death', 'mortality or invasive mechanical ventilation']","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]","[{'cui': 'C0001041', 'cui_str': 'Acetylcholine'}, {'cui': 'C0034261', 'cui_str': 'Pyridostigmine'}, {'cui': 'C0034262', 'cui_str': 'Pyridostigmine bromide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.747485,"This study will provide preliminary evidence of whether or not -by decreasing systemic inflammation- add-on PDG can improve clinical outcomes in patients with severe COVID-19.
","[{'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Fragoso-Saavedra', 'Affiliation': 'Programa de Estudios Combinados en Medicina (MD/PhD program), Universidad Nacional Autónoma de Mexico, Mexico City, Mexico.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Iruegas-Nunez', 'Affiliation': 'Departamento de Neurología, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Quintero-Villegas', 'Affiliation': 'Internal Medicine Residency Training Program, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'H Benjamín', 'Initials': 'HB', 'LastName': 'García-González', 'Affiliation': 'Internal Medicine Residency Training Program, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'Isaac', 'Initials': 'I', 'LastName': 'Nuñez', 'Affiliation': 'Internal Medicine Residency Training Program, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'Sergio L', 'Initials': 'SL', 'LastName': 'Carbajal-Morelos', 'Affiliation': 'Internal Medicine Residency Training Program, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'Belem M', 'Initials': 'BM', 'LastName': 'Audelo-Cruz', 'Affiliation': 'Departamento de Neurología, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'Sarahi', 'Initials': 'S', 'LastName': 'Arias-Martínez', 'Affiliation': 'Departamento de Neurología, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'Yanink', 'Initials': 'Y', 'LastName': 'Caro-Vega', 'Affiliation': 'Departamento de Infectología, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'Juan José', 'Initials': 'JJ', 'LastName': 'Calva', 'Affiliation': 'Departamento de Infectología, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'Verónica', 'Initials': 'V', 'LastName': 'Luqueño-Martínez', 'Affiliation': 'Departamento de Infectología, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'Alejandra', 'Initials': 'A', 'LastName': 'González-Duarte', 'Affiliation': 'Departamento de Neurología, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Crabtree-Ramírez', 'Affiliation': 'Departamento de Infectología, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'José C', 'Initials': 'JC', 'LastName': 'Crispín', 'Affiliation': 'Departamento de e Inmunología y Reumatología, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Sierra-Madero', 'Affiliation': 'Departamento de Infectología, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'Pablo F', 'Initials': 'PF', 'LastName': 'Belaunzarán-Zamudio', 'Affiliation': 'Departamento de Infectología, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'Sergio I', 'Initials': 'SI', 'LastName': 'Valdés-Ferrer', 'Affiliation': 'Departamento de Neurología, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico. sergio.valdesf@incmnsz.mx.'}]",BMC infectious diseases,['10.1186/s12879-020-05485-7']
1354,33066773,Effectiveness of a family-centered behavioral and educational counselling approach to improve periodontal health of pregnant women: a randomized controlled trial.,"BACKGROUND


Poor oral hygiene and high hormone levels during pregnancy can lead to a deterioration in periodontal health. This study assessed the effectiveness of a family-centered behavioral and educational counselling program on improving the periodontal health of women during pregnancy and postpartum.
METHODS


A randomized controlled trial was conducted among pregnant women (10th-22nd gestational week) and their husbands. Participating families were randomized into test and control groups. Intervention in the test group included explanation of oral health education (OHE) pamphlets, oral hygiene instruction, individualized feedback, and proposed solutions to overcome barriers in self-care. Reinforcements were implemented in the 3rd trimester of pregnancy and six months postpartum. In the control group, only OHE pamphlets were distributed. The assessed outcomes were bleeding on probing (BOP), periodontal pocket (Poc), loss of clinical attachment (LoA), and Visible Plaque Index (VPI). The data collection was carried out at baseline (T 0 ), in the 32nd gestational week (T 1 ), and 12 months postpartum (T 2 ).
RESULTS


Altogether 589 pregnant women were recruited, and 369 attended all three visits (test:188; control:181). In the test group, the mean VPI score at T 0  was 0.19, which decreased to 0.14 at T 1  and 0.15 at T 2 . In the control group, the mean VPI decreased from 0.19 at T 0  to 0.16 at T 1 , but increased to 0.22 at T 2 . A main effect of time and intervention and an interaction between time and intervention were detected (all p < 0.05), indicating that the intervention effect differed between T 1  and T 2 . The test group showed a significantly greater decrease over time than the control group did. Similarly, the mean BOP% decreased more significantly over time in the test group (T 0 :57%, T 1 :46%, T 2 :35%) than in the control group (T 0 :58%, T 1 :52%, T 2 :46%). For Poc and LoA, there were improvements in both study groups at 12 months postpartum, compared with during pregnancy (p < 0.001).
CONCLUSIONS


Providing family-centered, behavioral, and educational counselling to pregnant women at an early stage of pregnancy and with reinforcements can improve their oral hygiene and reduce gingival inflammation. The effect can be sustained over an extended period and is greater than that of distributing oral health leaflets alone.
TRIAL REGISTRATION


Clinicaltrials.gov , #NCT02937194. Registered 18 October 2016. Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT02937194?cond=Family-centered+oral+health+promotion+for+new+parents+and+their+infants&draw=2&rank=1.",2020,"A main effect of time and intervention and an interaction between time and intervention were detected (all p < 0.05), indicating that the intervention effect differed between T 1  and T 2 .","['pregnant women', 'women during pregnancy and postpartum', 'Altogether 589 pregnant women were recruited, and 369 attended all three visits (test:188; control:181', 'pregnant women (10th-22nd gestational week) and their husbands']","['family-centered behavioral and educational counselling approach', 'family-centered behavioral and educational counselling program', 'oral health education (OHE) pamphlets, oral hygiene instruction, individualized feedback, and proposed solutions to overcome barriers in self-care']","['mean VPI', 'mean VPI score', 'periodontal health', 'mean BOP', 'Poc), loss of clinical attachment (LoA), and Visible Plaque Index (VPI', 'bleeding on probing (BOP), periodontal pocket', 'oral hygiene and reduce gingival inflammation']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0242664', 'cui_str': 'Husband'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0018703', 'cui_str': 'Oral health education'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0204131', 'cui_str': 'Oral hygiene education'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205379', 'cui_str': 'Visible'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0031094', 'cui_str': 'Periodontal pocket'}, {'cui': 'C0029164', 'cui_str': 'Dental Hygiene'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0017574', 'cui_str': 'Gingivitis'}]",589.0,0.0573875,"A main effect of time and intervention and an interaction between time and intervention were detected (all p < 0.05), indicating that the intervention effect differed between T 1  and T 2 .","[{'ForeName': 'Pei', 'Initials': 'P', 'LastName': 'Liu', 'Affiliation': 'Dental Public Health, Faculty of Dentistry, The University of Hong Kong, Pokfulam, Hong Kong, SAR, China.'}, {'ForeName': 'Weiye', 'Initials': 'W', 'LastName': 'Wen', 'Affiliation': 'Dental Public Health, Faculty of Dentistry, The University of Hong Kong, Pokfulam, Hong Kong, SAR, China.'}, {'ForeName': 'Ka Fung', 'Initials': 'KF', 'LastName': 'Yu', 'Affiliation': 'Dental Public Health, Faculty of Dentistry, The University of Hong Kong, Pokfulam, Hong Kong, SAR, China.'}, {'ForeName': 'Xiaoli', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': 'Dental Public Health, Faculty of Dentistry, The University of Hong Kong, Pokfulam, Hong Kong, SAR, China.'}, {'ForeName': 'Edward Chin Man', 'Initials': 'ECM', 'LastName': 'Lo', 'Affiliation': 'Dental Public Health, Faculty of Dentistry, The University of Hong Kong, Pokfulam, Hong Kong, SAR, China.'}, {'ForeName': 'May Chun Mei', 'Initials': 'MCM', 'LastName': 'Wong', 'Affiliation': 'Dental Public Health, Faculty of Dentistry, The University of Hong Kong, Pokfulam, Hong Kong, SAR, China. mcmwong@hku.hk.'}]",BMC oral health,['10.1186/s12903-020-01265-6']
1355,33066794,Ticagrelor monotherapy in patients with concomitant diabetes mellitus and chronic kidney disease: a post hoc analysis of the GLOBAL LEADERS trial.,"BACKGROUND


Patients with both diabetes mellitus (DM) and chronic kidney disease (CKD) are a subpopulation characterized by ultrahigh ischemic and bleeding risk after percutaneous coronary intervention. There are limited data on the impact of ticagrelor monotherapy among these patients.
METHODS


In this post hoc analysis of the GLOBAL-LEADERS trial, the treatment effects of the experimental (one-month dual-antiplatelet therapy [DAPT] followed by 23-month ticagrelor monotherapy) versus the reference regimen (12-month DAPT followed by 12-month aspirin alone) were analyzed according to DM/CKD status. The primary endpoint was a composite endpoint of all-cause death or new Q-wave myocardial infarction at 2-years. The patient-oriented composite endpoint (POCE) was defined as the composite of all-cause death, any stroke, site-reported MI and any revascularization, whereas net adverse clinical events (NACE) combined POCE with BARC type 3 or 5 bleeding events.
RESULTS


At 2 years, the DM + /CKD + patients had significantly higher incidences of the primary endpoint (9.5% versus 3.1%, adjusted HR 2.16; 95% CI [1.66-2.80], p < 0.001), BARC type 3 or 5 bleeding events, stroke, site-reported myocardial infraction, all revascularization, POCE, and NACE, compared with the DM-/CKD- patients. Among the DM + /CKD + patients, after adjustment, there were no significant differences in the primary endpoints between the experimental and reference regimen; however, the experimental regimen was associated with lower rates of POCE (20.6% versus 25.9%, HR 0.74; 95% CI [0.55-0.99], p = 0.043, p interaction  = 0.155) and NACE (22.7% versus 28.3%, HR 0.75; 95% CI [0.56-0.99], p = 0.044, p interaction  = 0.310), which was mainly driven by a lower rate of all revascularization, as compared with the reference regimen. The landmark analysis showed that while the experimental and reference regimen had similar rates of all the clinical endpoints during the first year, the experimental regimen was associated with significantly lower rates of POCE (5.8% versus 11.0%, HR 0.49; 95% CI [0.29-0.82], p = 0.007, p interaction  = 0.040) and NACE (5.8% versus 11.2%, HR 0.48; 95% CI [0.29-0.82], p = 0.007, p interaction  = 0.013) in the second year.
CONCLUSION


Among patients with both DM and CKD, ticagrelor monotherapy was not associated with lower rates of all-cause death or new Q-wave, or major bleeding complications; however, it was associated with lower rates of POCE and NACE. These findings should be interpreted as hypothesis-generating.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov (NCT01813435).",2020,"ticagrelor monotherapy was not associated with lower rates of all-cause death or new Q-wave, or major bleeding complications; however, it was associated with lower rates of POCE and NACE.","['Patients with both diabetes mellitus (DM) and chronic kidney disease (CKD', 'patients with concomitant diabetes mellitus and chronic kidney disease', 'patients with both DM and CKD']","['Ticagrelor monotherapy', 'ticagrelor monotherapy']","['net adverse clinical events (NACE) combined POCE with BARC type 3 or 5 bleeding events', 'rates of POCE', 'BARC type 3 or 5 bleeding events, stroke, site-reported myocardial infraction, all revascularization, POCE, and NACE', 'composite endpoint of all-cause death or new Q-wave myocardial infarction at 2-years', 'NACE']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}]","[{'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0441731', 'cui_str': 'Type 3'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0429089', 'cui_str': 'Electrocardiogram Q waves'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0439234', 'cui_str': 'year'}]",,0.144396,"ticagrelor monotherapy was not associated with lower rates of all-cause death or new Q-wave, or major bleeding complications; however, it was associated with lower rates of POCE and NACE.","[{'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Gao', 'Affiliation': ""Department of Cardiology, Xijing hospital, Xi'an, China.""}, {'ForeName': 'Mariusz', 'Initials': 'M', 'LastName': 'Tomaniak', 'Affiliation': 'First Department of Cardiology, Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Kuniaki', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Hideyuki', 'Initials': 'H', 'LastName': 'Kawashima', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Rutao', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': ""Department of Cardiology, Xijing hospital, Xi'an, China.""}, {'ForeName': 'Hironori', 'Initials': 'H', 'LastName': 'Hara', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Ono', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Montalescot', 'Affiliation': 'Sorbonne University, ACTION Study Group, Institute of Cardiology, Pitié-Salpêtrière Hospital, Paris, France.'}, {'ForeName': 'Scot', 'Initials': 'S', 'LastName': 'Garg', 'Affiliation': 'Department of Cardiology, Royal Blackburn Hospital, Blackburn, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Haude', 'Affiliation': 'Department of Cardiology, Rheinland Klinikum Neuss, Lukaskrankenhaus, Neuss, Germany.'}, {'ForeName': 'Ton', 'Initials': 'T', 'LastName': 'Slagboom', 'Affiliation': 'OLVG, Amsterdam, Netherlands.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Vranckx', 'Affiliation': 'Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa Ziekenhuis, Hasselt, Belgium.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Valgimigli', 'Affiliation': 'Department of Cardiology, Bern University Hospital, Bern, Switzerland.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': 'Department of Cardiology, Bern University Hospital, Bern, Switzerland.'}, {'ForeName': 'Robert-Jan', 'Initials': 'RJ', 'LastName': 'van Geuns', 'Affiliation': 'Department of Cardiology, Radboud University, Nijmegen, The Netherlands.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hamm', 'Affiliation': 'Kerckhoff Heart Center, Bad Nauheim, Germany.'}, {'ForeName': 'Philippe Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'FACT, French Alliance for Cardiovascular Trials, Paris, France.'}, {'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Onuma', 'Affiliation': 'Department of Cardiology, National University of Ireland Galway, Galway, Ireland.'}, {'ForeName': 'Dominick J', 'Initials': 'DJ', 'LastName': 'Angiolillo', 'Affiliation': 'Division of Cardiology, University of Florida College of Medicine, Jacksonville, FL, USA.'}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': 'Department of Cardiology, National University of Ireland Galway, Galway, Ireland. patrick.w.j.c.serruys@gmail.com.'}]",Cardiovascular diabetology,['10.1186/s12933-020-01153-x']
1356,33067279,Effects of sulforaphane on cognitive function in patients with frontal brain damage: study protocol for a randomised controlled trial.,"INTRODUCTION


Many patients with frontal brain damage show serious cognitive function deficits, which hamper their quality of life and result in poor clinical outcomes. Preclinical research has shown that sulforaphane can significantly improve spatial localisation and working memory impairment after brain injury. The primary aim of this double-blind randomised controlled clinical trial is to assess the efficacy of sulforaphane for improving cognitive function in patients with frontal brain damage.
METHODS AND ANALYSIS


Ninety eligible patients will be randomly allocated to an active treatment or a placebo group in a 2:1 ratio. Participants will undergo a series of cognitive and neuropsychiatric tests at baseline (week 0) and after 12 weeks to determine the effect of sulforaphane on cognition. Magnetic resonance spectrum of the brain will be studied using the 3T MRIs of the brain to detect brain metabolites markers, including N-acetyl aspartate, glutamate (Glu), glutathione (GSH) and γ-aminobutyric acid (GABA). Blood brain-derived neurotrophic factor, Glu, GSH and GABA levels and gut microbiota will also be assessed over this period. This study will also evaluate long-term outcomes of brain trauma, brain tumours and cerebrovascular disease via exploratory analyses. The primary outcome will be the difference in scores of a battery of cognitive tests after 12 weeks of sulforaphane treatment. The secondary outcomes will be changes in the Functional Activities Questionnaire (FAQ), the Patient Health Questionnaire (PHQ-9), the Self-Rating Anxiety Scale, the changes in T1-weighted MRI and resting-state functional MRI findings, and changes in brain and blood metabolic markers and gut microbiota at weeks 0 and 12. We expect that sulforaphane will yield favourable results in treating memory and learning deficits for patients with frontal brain damage. Cognitive functional treatment may also improve brain trauma, brain tumours and cerebrovascular outcomes.
ETHICS AND DISSEMINATION


The study protocol has been approved by the Medical Ethics committee of the Xiangya Hospital of Central South University (No. 2017121019). The results will be disseminated in peer-reviewed journals and at international conferences.
TRIAL REGISTRATION NUMBER


This trial was registered on Clinicaltrials.gov on 31 January 2020 (NCT04252261). The protocol version is V.1.0 (20 December 2019).",2020,The primary outcome will be the difference in scores of a battery of cognitive tests after 12 weeks of sulforaphane treatment.,"['Xiangya Hospital of Central South University', 'patients with frontal brain damage', 'Ninety eligible patients']","['placebo', 'sulforaphane']","['Blood brain-derived neurotrophic factor, Glu, GSH and GABA levels and gut microbiota', 'N-acetyl aspartate, glutamate (Glu), glutathione (GSH) and γ-aminobutyric acid (GABA', 'scores of a battery of cognitive tests', 'cognitive function', 'brain trauma, brain tumours and cerebrovascular outcomes', 'Functional Activities Questionnaire (FAQ), the Patient Health Questionnaire (PHQ-9), the Self-Rating Anxiety Scale, the changes in T1-weighted MRI and resting-state functional MRI findings, and changes in brain and blood metabolic markers and gut microbiota']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0270611', 'cui_str': 'Brain injury'}, {'cui': 'C3816959', 'cui_str': '90'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0163159', 'cui_str': 'sulforafan'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0017789', 'cui_str': 'Glutamates'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0016904', 'cui_str': 'Gamma-aminobutyric acid'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0067684', 'cui_str': 'N-acetyl-L-aspartate'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C0006118', 'cui_str': 'Neoplasm of brain'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C1513159', 'cui_str': 'Metabolic marker'}]",90.0,0.269977,The primary outcome will be the difference in scores of a battery of cognitive tests after 12 weeks of sulforaphane treatment.,"[{'ForeName': 'Fangkun', 'Initials': 'F', 'LastName': 'Liu', 'Affiliation': 'Department of Neurosurgery, Central South University (CSU), 410008, Changsha, Hunan, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Department of Psychiatry, the Second Xiangya Hospital, Central South University, 410011, Changsha, Hunan, China; Mental Health Institute of the Second Xiangya Hospital, Central South University, Chinese National Clinical Research Center on Mental Disorders (Xiangya), Chinese National Technology Institute on Mental Disorders, Hunan Key Laboratory of Psychiatry and Mental Health, 410011, Changsha, Hunan, China.'}, {'ForeName': 'Gangrui', 'Initials': 'G', 'LastName': 'Hei', 'Affiliation': 'Department of Psychiatry, the Second Xiangya Hospital, Central South University, 410011, Changsha, Hunan, China; Mental Health Institute of the Second Xiangya Hospital, Central South University, Chinese National Clinical Research Center on Mental Disorders (Xiangya), Chinese National Technology Institute on Mental Disorders, Hunan Key Laboratory of Psychiatry and Mental Health, 410011, Changsha, Hunan, China.'}, {'ForeName': 'Renrong', 'Initials': 'R', 'LastName': 'Wu', 'Affiliation': 'Department of Psychiatry, the Second Xiangya Hospital, Central South University, 410011, Changsha, Hunan, China; Mental Health Institute of the Second Xiangya Hospital, Central South University, Chinese National Clinical Research Center on Mental Disorders (Xiangya), Chinese National Technology Institute on Mental Disorders, Hunan Key Laboratory of Psychiatry and Mental Health, 410011, Changsha, Hunan, China zhixiongliu@csu.edu.cn wurenrong@csu.edu.cn.'}, {'ForeName': 'Zhixiong', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Department of Neurosurgery, Central South University (CSU), 410008, Changsha, Hunan, China zhixiongliu@csu.edu.cn wurenrong@csu.edu.cn.'}]",BMJ open,['10.1136/bmjopen-2020-037543']
1357,33067294,Uptake and effectiveness of a tailor-made online lifestyle programme targeting modifiable risk factors for dementia among middle-aged descendants of people with recently diagnosed dementia: study protocol of a cluster randomised controlled trial (Demin study).,"INTRODUCTION


Descendants of patients with dementia have a higher risk to develop dementia. This study aims to investigate the uptake and effectiveness of an online tailor-made lifestyle programme for dementia risk reduction (DRR) among middle-aged descendants of people with recently diagnosed late-onset dementia.
METHODS AND ANALYSIS


Demin is a cluster randomised controlled trial, aiming to include 21 memory clinics of which 13 will be randomly allocated to the passive (poster and flyer in a waiting room) and 8 to the active recruitment strategy (additional personal invitation by members of the team of the memory clinic). We aim to recruit 378 participants (40-60 years) with a parent who is recently diagnosed with Alzheimer's disease or vascular dementia at one of the participating memory clinics. All participants receive a dementia risk assessment (online questionnaire, physical examination and blood sample) and subsequently an online tailor-made lifestyle advice regarding protective (Mediterranean diet, low/moderate alcohol consumption and high cognitive activity) and risk factors (physical inactivity, smoking, loneliness, cardiovascular diseases (CVD), hypertension, high cholesterol, diabetes, obesity, renal dysfunction and depression) for dementia. The primary outcome is the difference in uptake between the two recruitment strategies. Secondary outcomes are change(s) in (1) the Lifestyle for Brain Health score, (2) individual health behaviours, (3) health beliefs and attitudes towards DRR and (4) compliance to the tailor-made lifestyle advice. Outcomes will be measured at 3, 6, 9 and 12 months after baseline. The effectiveness of this online tailor-made lifestyle programme will be evaluated by comparing Demin participants to a matched control group (lifelines cohort).
ETHICS AND DISSEMINATION


This study has been approved by the Dutch Ministry of Health, Welfare and Sport according to the Population Screening Act. All participants have to give online informed consent using SMS-tan (transaction authentication number delivered via text message). Findings will be disseminated through peer-reviewed journals and (inter)national conferences.
TRIAL REGISTRATION NUMBER


NTR7434.",2020,"The effectiveness of this online tailor-made lifestyle programme will be evaluated by comparing Demin participants to a matched control group (lifelines cohort).
","['dementia risk reduction (DRR) among middle-aged descendants of people with recently diagnosed late-onset dementia', 'Demin participants to a matched control group (lifelines cohort', 'dementia among middle-aged descendants of people with recently diagnosed dementia', 'patients with dementia have a higher risk to develop dementia', ""378 participants (40-60 years) with a parent who is recently diagnosed with Alzheimer's disease or vascular dementia at one of the participating memory clinics"", '21 memory clinics of which 13 will be randomly allocated to the']","['tailor-made online lifestyle programme', 'dementia risk assessment (online questionnaire, physical examination and blood sample) and subsequently an online tailor-made lifestyle advice regarding protective (Mediterranean diet, low/moderate alcohol consumption and high cognitive activity', 'passive (poster and flyer in a waiting room) and 8 to the active recruitment strategy (additional personal invitation by members of the team of the memory clinic', 'online tailor-made lifestyle programme']","['Uptake and effectiveness', 'change(s) in (1) the Lifestyle for Brain Health score, (2) individual health behaviours, (3) health beliefs and attitudes towards DRR and (4) compliance to the tailor-made lifestyle advice', 'risk factors (physical inactivity, smoking, loneliness, cardiovascular diseases (CVD), hypertension, high cholesterol, diabetes, obesity, renal dysfunction and depression']","[{'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0011269', 'cui_str': 'Vascular dementia'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0086930', 'cui_str': 'Risk assessment'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0376675', 'cui_str': 'Posters'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0814098', 'cui_str': 'Health belief'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C3890554', 'cui_str': 'Physical Inactivity'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0020443', 'cui_str': 'Hypercholesterolemia'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",378.0,0.198922,"The effectiveness of this online tailor-made lifestyle programme will be evaluated by comparing Demin participants to a matched control group (lifelines cohort).
","[{'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Vrijsen', 'Affiliation': 'Department of Epidemiology, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands j.vrijsen@umcg.nl.'}, {'ForeName': 'Ameen', 'Initials': 'A', 'LastName': 'Abu-Hanna', 'Affiliation': 'Department of Medical Informatics, University of Amsterdam, Amsterdam UMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Els Lm', 'Initials': 'EL', 'LastName': 'Maeckelberghe', 'Affiliation': 'Wenckebach Institute for Training and Education, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Peter Paul', 'Initials': 'PP', 'LastName': 'De Deyn', 'Affiliation': 'Department of Neurology and Alzheimer Centre Groningen, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Andrea F', 'Initials': 'AF', 'LastName': 'de Winter', 'Affiliation': 'Department of Health Sciences, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Fransje E', 'Initials': 'FE', 'LastName': 'Reesink', 'Affiliation': 'Department of Neurology and Alzheimer Centre Groningen, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Richard C', 'Initials': 'RC', 'LastName': 'Oude Voshaar', 'Affiliation': 'Department of Psychiatry, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Buskens', 'Affiliation': 'Department of Epidemiology, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Sophia E', 'Initials': 'SE', 'LastName': 'de Rooij', 'Affiliation': 'Medical School Twente, Medical Spectrum Twente, Enschede, The Netherlands.'}, {'ForeName': 'Nynke', 'Initials': 'N', 'LastName': 'Smidt', 'Affiliation': 'Department of Epidemiology, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2020-039439']
1358,33067295,Internet-based patient- primary care physician-cardiologist integrated management model of hypertension in China: study protocol for a multicentre randomised controlled trial.,"INTRODUCTION


The control rate of hypertension is low in China, especially in rural, western and minority areas. This is related to poor medical skills among physicians in primary care institutions and low levels of trust among patients. However, primary healthcare institutions are the main battleground for the prevention and treatment of hypertension. It is worth exploring how to most effectively integrate patients, primary care physicians and cardiologists in tertiary hospitals, to build a long-term mechanism for the prevention and treatment of hypertension. In this study, we aim to evaluate the clinical effectiveness and conduct a health economic evaluation of an internet-based patient-primary care physician-cardiologist integrated management model of hypertension in areas of China with different socioeconomic levels.
METHODS AND ANALYSIS


This is a 12-month, multicentre, randomised controlled trial involving patients with hypertension in urban communities and rural areas of Sichuan Province, China. Each primary healthcare institution will cooperate with their tertiary hospital through the Red Shine Chronic Disease Management System (RSCDMS). Patients will be randomly assigned 1:1 to two groups: (1) a traditional care group; (2) an intervention group in which primary care physicians and cardiologists can share patient data and manage patients together through the RSCDMS. Patients can upload their blood pressure (BP) values and communicate with physicians using the system. The primary outcome is the change in systolic BP over a 12-month period. Secondary outcomes are changes in diastolic BP, BP control rate, values of 24-hour ambulatory BP monitoring, difference in cost-effectiveness between the groups, patient satisfaction, medication adherence and home BP monitoring compliance. All data will be recorded and stored in the RSCDMS and analysed using IBM SPSS V.26.0.
ETHICS AND DISSEMINATION


This study has been approved by the Biomedical Research Ethics Committee of the West China Hospital of Sichuan University in Sichuan, China (No. 2020-148). Written informed consent will be obtained from all participants. The results of this study will be disseminated to the public through academic conferences and peer-reviewed journals.
TRIAL REGISTRATION NUMBER


ChiCTR2000030677.",2020,Each primary healthcare institution will cooperate with their tertiary hospital through the Red Shine Chronic Disease Management System (RSCDMS).,"['hypertension in China', 'patients with hypertension in urban communities and rural areas of Sichuan Province, China', 'West China Hospital of Sichuan University in Sichuan, China (No. 2020-148', 'hypertension in areas of China with different socioeconomic levels']","['traditional care group; (2) an intervention group in which primary care physicians and cardiologists can share patient data and manage patients together through the RSCDMS', 'internet-based patient-primary care physician-cardiologist integrated management model', 'Internet-based patient- primary care physician-cardiologist integrated management model']","['changes in diastolic BP, BP control rate, values of 24-hour ambulatory BP monitoring, difference in cost-effectiveness between the groups, patient satisfaction, medication adherence and home BP monitoring compliance', 'change in systolic BP', 'blood pressure (BP) values']","[{'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0037769', 'cui_str': 'West syndrome'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0037464', 'cui_str': 'Factors, Socioeconomic'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0033131', 'cui_str': 'Primary care physician'}, {'cui': 'C0175906', 'cui_str': 'Cardiologist'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0332575', 'cui_str': 'Red color'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0242876', 'cui_str': 'Ambulatory Blood Pressure Monitoring'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0005825', 'cui_str': 'Sphygmomanometers, Continuous'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}]",,0.0735516,Each primary healthcare institution will cooperate with their tertiary hospital through the Red Shine Chronic Disease Management System (RSCDMS).,"[{'ForeName': 'Runyu', 'Initials': 'R', 'LastName': 'Ye', 'Affiliation': 'Cardiology, West China Hospital of Sichuan University, Chengdu, Sichaun, China.'}, {'ForeName': 'Rufeng', 'Initials': 'R', 'LastName': 'Shi', 'Affiliation': 'Cardiology, West China Hospital of Sichuan University, Chengdu, Sichaun, China.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Liu', 'Affiliation': 'Cardiology, West China Hospital of Sichuan University, Chengdu, Sichaun, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Cardiology, West China Hospital of Sichuan University, Chengdu, Sichaun, China.'}, {'ForeName': 'Si', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Cardiology, West China Hospital of Sichuan University, Chengdu, Sichaun, China.'}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Liao', 'Affiliation': 'Cardiology, West China Hospital of Sichuan University, Chengdu, Sichaun, China.'}, {'ForeName': 'Xinran', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Cardiology, West China Hospital of Sichuan University, Chengdu, Sichaun, China.'}, {'ForeName': 'Qiling', 'Initials': 'Q', 'LastName': 'Gou', 'Affiliation': 'Cardiology, West China Hospital of Sichuan University, Chengdu, Sichaun, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Rong', 'Affiliation': 'Cardiology, West China Hospital of Sichuan University, Chengdu, Sichaun, China.'}, {'ForeName': 'Zhipeng', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Cardiology, West China Hospital of Sichuan University, Chengdu, Sichaun, China.'}, {'ForeName': 'Changqiang', 'Initials': 'C', 'LastName': 'Yang', 'Affiliation': 'Cardiology, West China Hospital of Sichuan University, Chengdu, Sichaun, China.'}, {'ForeName': 'Xiangyu', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Cardiology, West China Hospital of Sichuan University, Chengdu, Sichaun, China.'}, {'ForeName': 'Xiaoping', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Cardiology, West China Hospital of Sichuan University, Chengdu, Sichaun, China xiaopingchen15@126.com.'}]",BMJ open,['10.1136/bmjopen-2020-039447']
1359,33072352,The effectiveness of telegram-based virtual education versus in-person education on the quality of life in adolescents with moderate-to-severe asthma: A pilot randomized controlled trial.,"Aim


In recent years, mobile applications have been developed for health education purposes. The aim of this study was to determine whether Telegram-based virtual education versus in-person education can be effective for improving the quality of life in adolescents with moderate-to-severe asthma.
Design


A single-blind randomized trial.
Methods


Participants were 64 adolescents aged 12-19 years and were equally assigned randomly to group A (Telegram-based education) and group B (in-person education) during 22 June 2017-19 February 2018. The educational contents were similar for both groups. The Mini Pediatric Asthma Quality of Life Questionnaire was used prior to intervention and 5 weeks postintervention for both groups of adolescents.
Results


A statistically significant increase was observed in the quality of life in both groups ( p  < .001). After controlling the quality-of-life scores, there was no statistically significant difference between the groups in terms of the mean score for the quality of life and its domains ( p  < .05).",2020,A statistically significant increase was observed in the quality of life in both groups ( p  < .001).,"['64 adolescents aged 12-19\xa0years', 'adolescents with moderate-to-severe asthma']","['telegram-based virtual education versus in-person education', 'Telegram-based virtual education versus in-person education']","['quality-of-life scores', 'quality of life', 'mean score for the quality of life and its domains', 'Mini Pediatric Asthma Quality of Life Questionnaire']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",64.0,0.0952909,A statistically significant increase was observed in the quality of life in both groups ( p  < .001).,"[{'ForeName': 'Shiva', 'Initials': 'S', 'LastName': 'Faraji', 'Affiliation': 'Department of Pediatric Nursing School of Nursing and Midwifery Tabriz University of Medical Sciences Tabriz Iran.'}, {'ForeName': 'Sousan', 'Initials': 'S', 'LastName': 'Valizadeh', 'Affiliation': 'Iranian Center for Evidence-Based Practice, Nursing and Midwifery School Tabriz University of Medical Sciences Tabriz Iran.'}, {'ForeName': 'Akbar', 'Initials': 'A', 'LastName': 'Sharifi', 'Affiliation': 'Tuberculosis and Lung Disease Research Center Tabriz University of Medical Sciences Tabriz Iran.'}, {'ForeName': 'Shahla', 'Initials': 'S', 'LastName': 'Shabazi', 'Affiliation': 'Department of Medical-Surgical Nursing, Nursing and Midwifery School Tabriz University of Medical Sciences Tabriz Iran.'}, {'ForeName': 'Morteza', 'Initials': 'M', 'LastName': 'Ghojazadeh', 'Affiliation': 'Iranian Center for Evidence-Based Practice, Medicine School Tabriz University of Medical Sciences Tabriz Iran.'}]",Nursing open,['10.1002/nop2.552']
1360,33072363,"Effects of a person-centred and thriving-promoting intervention on nursing home staff job satisfaction: A multi-centre, non-equivalent controlled before-after study.","Aim


To evaluate the effects of a person-centred and thriving-promoting intervention in nursing homes on staff job satisfaction, stress of conscience and the person-centredness of care and of the environment.
Design


A multi-centre, non-equivalent control group, before-after trial design.
Methods


Staff ( N  = 341) from six nursing homes in Australia, Norway and Sweden were assigned to the intervention or the control group and both groups were evaluated before the intervention, immediately after and by 6 months follow-up. Staff completed a questionnaire about job satisfaction (primary endpoint), stress of conscience and the person-centredness of care and of the environment (secondary endpoints). Linear regression models were used to identify the mean scores and to analyse group differences to test the effects of the intervention.
Results


The intervention had no statistically significant effects on staff job satisfaction, level of stress of conscience or the perceived person-centredness of care and of the environment.",2020,"The intervention had no statistically significant effects on staff job satisfaction, level of stress of conscience or the perceived person-centredness of care and of the environment.","[' N \xa0=\xa0341) from six nursing homes in Australia, Norway and Sweden', 'nursing homes on staff job satisfaction, stress of conscience and the person-centredness of care and of the environment']",['person-centred and thriving-promoting intervention'],"['questionnaire about job satisfaction (primary endpoint), stress of conscience and the person-centredness of care and of the environment (secondary endpoints', 'staff job satisfaction, level of stress of conscience or the perceived person-centredness of care and of the environment']","[{'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0028423', 'cui_str': 'Norway'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0022397', 'cui_str': 'Work Satisfaction'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0009790', 'cui_str': 'Conscience'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0014406', 'cui_str': 'Environment'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0022397', 'cui_str': 'Work Satisfaction'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0009790', 'cui_str': 'Conscience'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",341.0,0.0350752,"The intervention had no statistically significant effects on staff job satisfaction, level of stress of conscience or the perceived person-centredness of care and of the environment.","[{'ForeName': 'Tove Karin', 'Initials': 'TK', 'LastName': 'Vassbø', 'Affiliation': 'Faculty of Medicine Institute of Health and Society Oslo University Oslo Norway.'}, {'ForeName': 'Ådel', 'Initials': 'Å', 'LastName': 'Bergland', 'Affiliation': 'Lovisenberg Diaconal University College Oslo Norway.'}, {'ForeName': 'Marit', 'Initials': 'M', 'LastName': 'Kirkevold', 'Affiliation': 'Faculty of Medicine Institute of Health and Society Oslo University Oslo Norway.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Lindkvist', 'Affiliation': 'Department of Epidemiology and Global Health Umeå University Umeå Sweden.'}, {'ForeName': 'Qarin', 'Initials': 'Q', 'LastName': 'Lood', 'Affiliation': 'Department of Health and Rehabilitation Institute of Neuroscience and Physiology Sahlgrenska Academy Centre for Ageing and Health (AgeCap) University of Gothenburg Gothenburg Sweden.'}, {'ForeName': 'Per-Olof', 'Initials': 'PO', 'LastName': 'Sandman', 'Affiliation': 'Department of Nursing Umeå University Umeå Sweden.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Sjögren', 'Affiliation': 'Department of Nursing Umeå University Umeå Sweden.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Edvardsson', 'Affiliation': 'Department of Nursing Umeå University Umeå Sweden.'}]",Nursing open,['10.1002/nop2.565']
1361,33072373,The effectiveness of healthy lifestyle interventions on weight gain in overweight pregnant women: A cluster-randomized controlled trial.,"Aim


Interventions based on adopting a healthy lifestyle have been less successful. The aim of this study was to investigate the effectiveness of healthy lifestyle interventions on weight gain in overweight pregnant women.
Design


A cluster randomized controlled trial.
Methods


Health centres were selected by simple random sampling; then, 66 overweight pregnant women were enrolled by convenience sampling and divided into intervention and comparison groups. Intervention group received individual nutritional counselling and physical activity training. The data were collected in several stages with the demographic and obstetric questionnaire, maternal weight record, food frequency and international physical activity questionnaire.
Results


Pregnancy weight gain-4.75(CI 95%: -4.02, -5.48) was significantly lower in the intervention group ( p  < .001). Comparing between groups with adjustment for baseline values indicated that there was a statistically significant difference in terms of total calorie 95.46 (CI 95%: -22.37, 213.30), carbohydrate 23.45 (CI 95%: 2.12, 44.78), protein -7.16 (CI 95%: -12.85, -1.47) and fat 8.82 (CI 95%: 2.21, 15.67) intake. Despite the higher level of physical activity in the intervention group, there was no statistically significant difference between the two groups.
Conclusion


Counselling interventions for healthy living during pregnancy can lead to controlling weight gain, improving dietary habits and increasing the physical activity in overweight pregnant women.",2020,"-4.02, -5.48) was significantly lower in the intervention group ( p  < .001).","['66 overweight pregnant women', 'Pregnancy weight gain-4.75(CI 95', 'healthy living during pregnancy', 'overweight pregnant women']","['healthy lifestyle interventions', 'individual nutritional counselling and physical activity training']","['level of physical activity', 'demographic and obstetric questionnaire, maternal weight record, food frequency and international physical activity questionnaire', 'total calorie', 'weight gain']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}]",66.0,0.0964744,"-4.02, -5.48) was significantly lower in the intervention group ( p  < .001).","[{'ForeName': 'Sepideh', 'Initials': 'S', 'LastName': 'Hajian', 'Affiliation': 'Department of Midwifery & Reproductive Health Faculty of Nursing & Midwifery Shahid Beheshti University of Medical Sciences Tehran Iran.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Aslani', 'Affiliation': 'Medical student, Student Research Committee, Tabriz Branch Islamic Azad University Tabriz Iran.'}, {'ForeName': 'Parvin', 'Initials': 'P', 'LastName': 'Sarbakhsh', 'Affiliation': 'Department of Statistics and Epidemiology School of Public Health Tabriz University of Medical Sciences Tabriz Iran.'}, {'ForeName': 'Azita', 'Initials': 'A', 'LastName': 'Fathnezhad-Kazemi', 'Affiliation': 'Department of Midwifery Faculty of Nursing and Midwifery, Tabriz Branch Islamic Azad University Tabriz Iran.'}]",Nursing open,['10.1002/nop2.577']
1362,33072380,Effect of intradialytic progressive resistance exercise on physical fitness and quality of life in maintenance haemodialysis patients.,"Purpose


To investigate the impact of intradialytic progressive resistance exercise (IPRE) on physical fitness and quality of life in maintenance haemodialysis (MHD) patients.
Methods


Subjects were allocated randomly to the exercise group received IPRE and the control group underwent a haemodialysis session alone. Outcomes measured were including physical fitness ascertained by 6-min walk test, sit-to-stand 10 test and handgrip strength. Kidney Disease Quality of Life Instrument was used to assess the quality of life, and also recorded the adverse event at each exercise session.
Results


A total of 87 patients were analysed: 43 in the exercise group and 44 in the control group. After 12 weeks, there were significant improvements in physical fitness and past of the dimension of the scale in the exercise group.
Conclusions


IPRE can improve the physical fitness and quality of life in patients underwent MHD with no serious adverse events or safety issues.",2020,"After 12 weeks, there were significant improvements in physical fitness and past of the dimension of the scale in the exercise group.
","['A total of 87 patients were analysed: 43 in the exercise group and 44 in the control group', 'maintenance haemodialysis patients', 'maintenance haemodialysis (MHD) patients']","['exercise group received IPRE', 'intradialytic progressive resistance exercise', 'haemodialysis session alone', 'intradialytic progressive resistance exercise (IPRE']","['physical fitness and past of the dimension of the scale', 'quality of life', 'physical fitness and quality of life', 'physical fitness ascertained by 6-min walk test, sit-to-stand 10 test and handgrip strength']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4040576', 'cui_str': 'Maintenance hemodialysis'}]","[{'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}]","[{'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",87.0,0.0207824,"After 12 weeks, there were significant improvements in physical fitness and past of the dimension of the scale in the exercise group.
","[{'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': 'Nephrology Department Longhua Hospital Shanghai University of Traditional Chinese Medicine Shanghai China.'}, {'ForeName': 'Liuyan', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': 'Nephrology Department Longhua Hospital Shanghai University of Traditional Chinese Medicine Shanghai China.'}, {'ForeName': 'Weiqiong', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Hemodialysis Center Longhua Hospital Shanghai University of Traditional Chinese Medicine Shanghai China.'}, {'ForeName': 'Qiyun', 'Initials': 'Q', 'LastName': 'Shen', 'Affiliation': 'Nephrology Department Longhua Hospital Shanghai University of Traditional Chinese Medicine Shanghai China.'}, {'ForeName': 'Huachun', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Nursing Longhua Hospital Shanghai University of Traditional Chinese Medicine Shanghai China.'}]",Nursing open,['10.1002/nop2.585']
1363,33072423,"Spinal versus general anesthesia in gynecologic laparoscopy: A prospective, randomized study.","Objective


To compare spinal anesthesia (SA) with general anesthesia (GA) in gynecologic laparoscopic surgery regarding anesthetic parameters and patient satisfaction together with an assessment of total oxidant, antioxidant levels, and Oxidative Stress index (OSI).
Materials and Methods


Sixty patients who were planned to undergo gynecologic laparoscopy were randomized into group G (GA) and group S (SA). Demographics, adverse events and anesthetic parameters were recorded before induction, after induction, and at the 5 th , 10 th , 15 th , 30 th , 60 th , 90 th , and 120 th  minutes. Patients and surgeons completed questionnaires. Total antioxidant capacity (TAC), total oxidant level (TOL), and OSI were measured.
Results


There was no difference between the groups in terms of hemodynamic parameters except heart rate at 30 th  minute and mean arteral pressure at 10 th , 15 th , 30 th , and 60 th  minute (p<0.05). The postoperative arterial blood pH value was lower in group S (p=0.021). Intraoperative hypotension was lower in group S (p=0.038). There was more intraoperative hypotension in group S when compared with group G (p=0.038). Postoperative analgesic consumption was higher and onset of postoperative pain was shorter in group G (p=0.001 for both). There was no difference between the groups in terms of patient and surgeon satisfaction. There was no difference in terms of TAC, TOL, and OSI between the groups (p=0.862, p=0.940, and p=0.728, respectively).
Conclusion


SA may become a reliable alternative to GA in gynecologic laparoscopy when hemodynamic and respiratory parameters, patient and surgeon satisfaction, as well as total oxidant, antioxidant levels, and OSI are considered.",2020,Postoperative analgesic consumption was higher and onset of postoperative pain was shorter in group G (p=0.001 for both).,"['Sixty patients who were planned to undergo gynecologic laparoscopy', 'gynecologic laparoscopy']","['Spinal versus general anesthesia', 'spinal anesthesia (SA) with general anesthesia (GA']","['total oxidant, antioxidant levels, and OSI', 'Postoperative analgesic consumption', 'TAC, TOL, and OSI', 'Demographics, adverse events and anesthetic parameters', 'Intraoperative hypotension', 'postoperative arterial blood pH value', 'postoperative pain', 'patient and surgeon satisfaction', 'total oxidant, antioxidant levels, and Oxidative Stress index (OSI', 'hemodynamic parameters except heart rate', 'intraoperative hypotension', 'Total antioxidant capacity (TAC), total oxidant level (TOL), and OSI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0205480', 'cui_str': 'Gynecologic'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}]","[{'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0085403', 'cui_str': 'Oxidizing Agents'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C3489891', 'cui_str': 'TAC Alternate'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1112259', 'cui_str': 'Intraoperative hypotension'}, {'cui': 'C0428199', 'cui_str': 'pH measurement, arterial'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",60.0,0.0425467,Postoperative analgesic consumption was higher and onset of postoperative pain was shorter in group G (p=0.001 for both).,"[{'ForeName': 'Berna', 'Initials': 'B', 'LastName': 'Kaya Uğur', 'Affiliation': 'Gaziantep University Faculty of Medicine, Department of Anesthesiology and Reanimation, Gaziantep, Turkey.'}, {'ForeName': 'Lütfiye', 'Initials': 'L', 'LastName': 'Pirbudak', 'Affiliation': 'Gaziantep University Faculty of Medicine, Department of Anesthesiology and Reanimation, Gaziantep, Turkey.'}, {'ForeName': 'Ebru', 'Initials': 'E', 'LastName': 'Öztürk', 'Affiliation': 'Gaziantep University Faculty of Medicine, Department of Obstetrics and Gynecology, Gaziantep, Turkey.'}, {'ForeName': 'Özcan', 'Initials': 'Ö', 'LastName': 'Balat', 'Affiliation': 'Gaziantep University Faculty of Medicine, Department of Obstetrics and Gynecology, Gaziantep, Turkey.'}, {'ForeName': 'Mete Gürol', 'Initials': 'MG', 'LastName': 'Uğur', 'Affiliation': 'Gaziantep University Faculty of Medicine, Department of Obstetrics and Gynecology, Gaziantep, Turkey.'}]",Turkish journal of obstetrics and gynecology,['10.4274/tjod.galenos.2020.28928']
1364,33072497,Private well water testing promotion in pediatric preventive care: A randomized intervention study.,"Over 43 million U.S. residents rely on private unregulated wells for their drinking water, raising public health concerns, particularly in regions like northern New England where widespread groundwater arsenic contamination is now recognized. Children are particularly vulnerable to adverse health effects from arsenic exposure. Despite AAP Guidelines, approaches to engage pediatric clinicians in promoting private well testing have not been previously described. We sought to determine the most effective practice approaches to achieve successful well water testing in routine pediatric care. 12 primary care clinics were block randomized to one of four study arms. Two intervention variables were assessed: (1) test results access (parent only vs. parent and clinic) and (2) follow up approaches (yes/no). Parents of children under 12 months using a private well were eligible. Prepaid water tests were provided. Primary outcome was parental water test completion. Eleven clinics successfully implemented processes identifying well users. 240 testing kits were dispensed. Completion rates averaged 29% (range 10 to 61%). The study arm with both clinic results access and staff follow up system was 2.3 times more likely to achieve test completion than other arms (95% CI 1.12-4.86, p = .03). Kit distribution by clinicians versus nursing staff, irrespective of study arm, had 2.4 times greater completion (95% CI 1.13-5.11, p = .02). Systematic drinking water source screening can be improved in pediatric care. Higher testing completion was found in practices randomized to reminders and structured follow up versus single visit discussion, but clinician involvement was the most predictive factor.",2020,"Higher testing completion was found in practices randomized to reminders and structured follow up versus single visit discussion, but clinician involvement was the most predictive factor.","['pediatric preventive care', '12 primary care clinics', 'Parents of children under 12\xa0months using a private well were eligible']",[],"['parental water test completion', 'Completion rates']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C4277527', 'cui_str': 'Preventative Care'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0033175', 'cui_str': 'Private Room'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",[],"[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]",,0.0852627,"Higher testing completion was found in practices randomized to reminders and structured follow up versus single visit discussion, but clinician involvement was the most predictive factor.","[{'ForeName': 'Carolyn J', 'Initials': 'CJ', 'LastName': 'Murray', 'Affiliation': ""Children's Environmental Health and Disease Prevention Research Center at Dartmouth, Dartmouth Geisel School of Medicine, 1 Medical Center Drive, Lebanon, NH 03756, USA.""}, {'ForeName': 'Ardis L', 'Initials': 'AL', 'LastName': 'Olson', 'Affiliation': 'Dartmouth CO-OP Primary Care Research Network, Dartmouth Geisel School of Medicine, 46 Centerra Parkway, Lebanon, NH 03766, USA.'}, {'ForeName': 'Ellen L', 'Initials': 'EL', 'LastName': 'Palmer', 'Affiliation': 'Department of Biomedical Data Science, Dartmouth Geisel School of Medicine, 1 Medical Center Drive, Lebanon, NH 03756, USA.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Yang', 'Affiliation': 'Department of Biomedical Data Science, Dartmouth Geisel School of Medicine, 1 Medical Center Drive, Lebanon, NH 03756, USA.'}, {'ForeName': 'Christopher I', 'Initials': 'CI', 'LastName': 'Amos', 'Affiliation': 'Department of Biomedical Data Science, Dartmouth Geisel School of Medicine, 1 Medical Center Drive, Lebanon, NH 03756, USA.'}, {'ForeName': 'Deborah J', 'Initials': 'DJ', 'LastName': 'Johnson', 'Affiliation': 'Dartmouth CO-OP Primary Care Research Network, Dartmouth Geisel School of Medicine, 46 Centerra Parkway, Lebanon, NH 03766, USA.'}, {'ForeName': 'Margaret R', 'Initials': 'MR', 'LastName': 'Karagas', 'Affiliation': ""Children's Environmental Health and Disease Prevention Research Center at Dartmouth, Dartmouth Geisel School of Medicine, 1 Medical Center Drive, Lebanon, NH 03756, USA.""}]",Preventive medicine reports,['10.1016/j.pmedr.2020.101209']
1365,33072640,Comparing the safety and efficacy of three different doses of atracurium in facilitating the insertion of laryngeal mask airway in patients undergoing phacoemulsification cataract surgery: A randomized clinical trial.,"Background


In this study, we aimed to evaluate the safety and efficacy of three different doses of atracurium on conditions of laryngeal mask airway (LMA) insertion, first-try success rate, and possible complications.
Materials and Methods


A total of 120 patient's ≥18 years old were randomly divided into three groups of 40. The study groups received fentanyl 2 μg/kg thiopental 5 mg/kg and atracurium in doses 0.2 mg/kg, 0.4 mg/kg, and 0.6 mg/kg, respectively, based on the patient group. The conditions of LMA insertion, hemodynamic responses, and complications were evaluated and compared in the groups.
Results


In the study groups, the LMA placement was difficult in 15%, 7.5%, and 2.5%, respectively ( P  = 0.13). There was no statistically significant difference among the groups regarding the success rate in the first attempt to the insertion of LMA. Of the three groups, 5%, 2.5%, and 2.5% had bleeding at the place of mask insertion ( P  = 0.77). 17.5%, 7.5%, and12.5% had sore throat, respectively ( P  = 0.4). No patient experienced laryngospasm during the study. Furthermore, changes in blood pressure, heart rate, and oxygen saturation were not significant in the three groups.
Conclusion


All three doses of atracurium have similar effects on the condition of LMA insertion. Atracurium 0.4 mg/kg accompanied by higher success on LMA insertion in the first attempt and lower airway complications (bleeding and sore throat), increasing this dose had no significant effect on the success rate of LMA insertion.",2020,There was no statistically significant difference among the groups regarding the success rate in the first attempt to the insertion of LMA.,"[""A total of 120 patient's ≥18 years old"", 'patients undergoing phacoemulsification cataract surgery']","['atracurium', 'fentanyl 2 μg/kg thiopental 5 mg/kg and atracurium', 'Atracurium']","['LMA placement', 'conditions of laryngeal mask airway (LMA) insertion, first-try success rate, and possible complications', 'blood pressure, heart rate, and oxygen saturation', 'success rate', 'sore throat', 'success rate of LMA insertion', 'safety and efficacy', 'airway complications (bleeding and sore throat', 'bleeding at the place of mask insertion', 'LMA insertion, hemodynamic responses, and complications']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0282545', 'cui_str': 'Phacoemulsification'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}]","[{'cui': 'C0004234', 'cui_str': 'Atracurium'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0039925', 'cui_str': 'Thiopental'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}]","[{'cui': 'C0162645', 'cui_str': 'Laryngeal mask'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0031350', 'cui_str': 'Pharyngitis'}, {'cui': 'C0396618', 'cui_str': 'Laryngeal mask airway insertion'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}]",,0.0872763,There was no statistically significant difference among the groups regarding the success rate in the first attempt to the insertion of LMA.,"[{'ForeName': 'Hamidreza', 'Initials': 'H', 'LastName': 'Shetabi', 'Affiliation': 'Anesthesiology and Critical Care Research Center, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Elnaz', 'Initials': 'E', 'LastName': 'Jebelli', 'Affiliation': 'Anesthesiology and Critical Care Research Center, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Shafa', 'Affiliation': 'Anesthesiology and Critical Care Research Center, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.'}]",Advanced biomedical research,['10.4103/abr.abr_61_19']
1366,33072694,School-Based Intervention to Improve Healthy Eating Practices Among Malaysian Adolescents: A Feasibility Study Protocol.,"Introduction:  School environments can influence students' dietary habits. Hence, implementing a healthy canteen intervention programme in schools is a recommended strategy to improve students' dietary intake. This study will evaluate the feasibility of providing healthier food and beverage options in selected secondary schools in Malaysia by working with canteen vendors. It also will assess the changes in food choices before and after the intervention.  Methods:  A feasibility cluster randomised controlled study will be conducted in six secondary schools (intervention,  n  = 4; control,  n  = 2) comprising of rural and urban schools located in Selangor and Perak states in Malaysia. Four weeks of intervention will be conducted among Malaysian adolescents aged 15 years old. Two interventions are proposed that will focus on providing healthier food options in the canteen and convenience shops in the selected schools. Interventions 1 and 2 will entail training the canteen and school convenience shop operators. Intervention 2 will be applied to subsidise the cost of low energy-dense  kuih  (traditional cake), vegetables, and fruits. The control group will continue to sell the usual food. Trained dietitians will audit the canteen menu and food items sold by the school canteen and convenience shops in all schools. Anthropometric measurements, blood pressure and dietary assessment will be collected at baseline and at the end of 4-week intervention. Focus group discussions with students and in-depth interviews with headmasters, teachers, and school canteen operators will be conducted post-intervention to explore intervention acceptability. Under this Healthy School Canteen programme, school canteens will be prohibited from selling ""red flag"" foods. This refers to foods which are energy-dense and not nutritious, such as confectionery and deep-fried foods. They will also be prohibited from selling soft drinks, which are sugar-rich. Instead, the canteens will be encouraged to sell ""green flag"" food and drinks, such as fruits and vegetables.  Conclusion:  It is anticipated that this feasibility study can provide a framework for the conception and implementation of nutritional interventions in a future definitive trial at the school canteens in Malaysia.",2020,Trained dietitians will audit the canteen menu and food items sold by the school canteen and convenience shops in all schools.,"['Malaysian Adolescents', 'six secondary schools (intervention,  n  = 4; control,  n  = 2) comprising of rural and urban schools located in Selangor and Perak states in Malaysia', 'Healthy Eating Practices', ""students' dietary habits"", 'selected secondary schools in Malaysia by working with canteen vendors', 'Malaysian adolescents aged 15 years old']",['School-Based Intervention'],"['Anthropometric measurements, blood pressure and dietary assessment']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0036530', 'cui_str': 'Secondary school'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0024552', 'cui_str': 'Malaysia'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0086152', 'cui_str': 'Diet Habits'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0042462', 'cui_str': 'Vendors'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",,0.0242548,Trained dietitians will audit the canteen menu and food items sold by the school canteen and convenience shops in all schools.,"[{'ForeName': 'Shooka', 'Initials': 'S', 'LastName': 'Mohammadi', 'Affiliation': 'Department of Social and Preventive Medicine, Faculty of Medicine, Centre of Population Health, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Tin Tin', 'Initials': 'TT', 'LastName': 'Su', 'Affiliation': 'Department of Social and Preventive Medicine, Faculty of Medicine, Centre of Population Health, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Muhammad Yazid', 'Initials': 'MY', 'LastName': 'Jalaludin', 'Affiliation': 'Department of Paediatrics, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Maznah', 'Initials': 'M', 'LastName': 'Dahlui', 'Affiliation': 'Department of Social and Preventive Medicine, Faculty of Medicine, Centre of Population Health, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Mohd Nahar', 'Initials': 'MN', 'LastName': 'Azmi Mohamed', 'Affiliation': 'Department of Sports Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Angeliki', 'Initials': 'A', 'LastName': 'Papadaki', 'Affiliation': 'Centre for Exercise, Nutrition and Health Sciences, School for Policy Studies, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Jago', 'Affiliation': 'Centre for Exercise, Nutrition and Health Sciences, School for Policy Studies, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Zoi', 'Initials': 'Z', 'LastName': 'Toumpakari', 'Affiliation': 'Centre for Exercise, Nutrition and Health Sciences, School for Policy Studies, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Hazreen A', 'Initials': 'HA', 'LastName': 'Majid', 'Affiliation': 'Department of Social and Preventive Medicine, Faculty of Medicine, Centre of Population Health, University of Malaya, Kuala Lumpur, Malaysia.'}]",Frontiers in public health,['10.3389/fpubh.2020.549637']
1367,33072885,Biomarkers and antithrombotic treatment in cervical artery dissection - Design of the TREAT-CAD randomised trial.,"Introduction


The type of antithrombotic treatment in cervical artery dissection patients is still a matter of debate. Most physicians prefer anticoagulants over antiplatelet agents for stroke prevention. However, this approach is not evidence-based and antiplatelets might be as safe and as effective. The 'Biomarkers and Antithrombotic Treatment in Cervical Artery Dissection' ('TREAT-CAD') trial (clinicaltrials.gov: NCT02046460) compares Aspirin to oral anticoagulants (vitamin K antagonists) with regard to efficacy and safety by using both clinical and imaging surrogate outcome measures. TREAT-CAD tests the hypothesis, that aspirin is as safe and effective as vitamin K antagonists.
Patients and methods


TREAD-CAD is a  P rospective,  R andomised controlled,  O pen-labelled, multicentre, non-inferiority trial with  B linded assessment of outcome  E vents (PROBE-design). Key eligibility criteria are (i) clinical symptoms attributable to cervical artery dissection and (ii) verification of the cervical artery dissection diagnosis by established magnetic resonance imaging criteria. Patients are randomised to receive either Aspirin 300 mg daily or vitamin K antagonists for 90 days.
Results


Primary outcomes are assessed at 14 ± 10 days (magnetic resonance imaging and clinical examination) and at 90 ± 30 days (clinical examinations). The primary endpoint is a composite outcome measure - labelled  C erebrovascular  I schemia, major  H emorrhagic events or  D eath (CIHD) - and includes (i) occurrence of any stroke (including retinal infarction), (ii) new ischaemic lesions on diffusion-weighted magnetic resonance imaging, (iii) any major extracranial haemorrhage, (iv) any symptomatic intracranial haemorrhage, (v) any new haemorrhagic lesion visible on paramagnetic-susceptible sequences and (vi) death.
Discussion


After database closure, (i) central verification of cervical artery dissection diagnosis will be done by two experienced raters, (ii) adjudication of outcome events will be performed by independent adjudication committees, separately for clinical and imaging outcomes. The primary analysis will be done on the per protocol data set. The targeted sample size consists of 169 evaluable patients in the per protocol data set.
Conclusion


TREAT-CAD is testing the non-inferiority of Aspirin versus vitamin K antagonists treatment in patients with symptomatic cervical artery dissection by combined clinical and magnetic resonance imaging outcomes.",2020,"The primary endpoint is a composite outcome measure - labelled  C erebrovascular  I schemia, major  H emorrhagic events or  D eath (CIHD) - and includes (i) occurrence of any stroke (including retinal infarction), (ii) new ischaemic lesions on diffusion-weighted magnetic resonance imaging, (iii) any major extracranial haemorrhage, (iv) any symptomatic intracranial haemorrhage, (v) any new haemorrhagic lesion visible on paramagnetic-susceptible sequences and (vi) death.
","['169 evaluable patients in the per protocol data set', 'patients with symptomatic cervical artery dissection', 'cervical artery dissection patients']","['Aspirin 300\u2009mg daily or vitamin K antagonists', 'Aspirin to oral anticoagulants (vitamin K antagonists', 'Aspirin versus vitamin K antagonists', 'aspirin']","['14\u2009±\u200910\u2009days (magnetic resonance imaging and clinical examination) and at 90\u2009±\u200930\u2009days (clinical examinations', 'composite outcome measure - labelled  C erebrovascular  I schemia, major  H emorrhagic events or  D eath (CIHD) - and includes (i) occurrence of any stroke (including retinal infarction), (ii) new ischaemic lesions on diffusion-weighted magnetic resonance imaging, (iii) any major extracranial haemorrhage, (iv) any symptomatic intracranial haemorrhage, (v) any new haemorrhagic lesion visible on paramagnetic-susceptible sequences and (vi) death']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0150098', 'cui_str': 'Data Set'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0002949', 'cui_str': 'Dissection of artery'}]","[{'cui': 'C0983862', 'cui_str': 'Aspirin 300 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1096489', 'cui_str': 'Vitamin K antagonist'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0281967', 'cui_str': 'Retinal infarction'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0598801', 'cui_str': 'Diffusion weighted magnetic resonance imaging'}, {'cui': 'C0580586', 'cui_str': 'Extracranial'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0151699', 'cui_str': 'Intracranial hemorrhage'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic'}, {'cui': 'C0205379', 'cui_str': 'Visible'}, {'cui': 'C0231204', 'cui_str': 'Susceptible'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.354109,"The primary endpoint is a composite outcome measure - labelled  C erebrovascular  I schemia, major  H emorrhagic events or  D eath (CIHD) - and includes (i) occurrence of any stroke (including retinal infarction), (ii) new ischaemic lesions on diffusion-weighted magnetic resonance imaging, (iii) any major extracranial haemorrhage, (iv) any symptomatic intracranial haemorrhage, (v) any new haemorrhagic lesion visible on paramagnetic-susceptible sequences and (vi) death.
","[{'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Traenka', 'Affiliation': 'Department of Neurology and Stroke Center, University Hospital Basel and University of Basel, Basel, Switzerland.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Gensicke', 'Affiliation': 'Department of Neurology and Stroke Center, University Hospital Basel and University of Basel, Basel, Switzerland.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Schaedelin', 'Affiliation': 'Department of Clinical Research, Clinical Trial Unit, University Hospital Basel and University of Basel, Basel, Switzerland.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Luft', 'Affiliation': 'Division of Vascular Neurology and Neurorehabilitation, Department of Neurology, University Hospital of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Arnold', 'Affiliation': 'Department of Neurology, University Hospital Bern, Bern, Switzerland.'}, {'ForeName': 'Patrik', 'Initials': 'P', 'LastName': 'Michel', 'Affiliation': 'Stroke Center and Neurology Service, Department of Clinical Neurosciences, Centre Hospitalier Universitaire Vaudois and University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Kägi', 'Affiliation': 'Department of Neurology and Stroke Center, Cantonal Hospital St. Gallen, St. Gallen, Switzerland.'}, {'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Kahles', 'Affiliation': 'Department of Neurology and Stroke Center, Cantonal Hospital Aarau, Aarau, Switzerland.'}, {'ForeName': 'Christian H', 'Initials': 'CH', 'LastName': 'Nolte', 'Affiliation': 'Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Klinik und Hochschulambulanz für Neurologie, Berlin, Germany.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Kellert', 'Affiliation': 'Department of Neurology, Ludwig Maximilian University, Munich, Germany.'}, {'ForeName': 'Sverre', 'Initials': 'S', 'LastName': 'Rosenbaum', 'Affiliation': 'Department of Neurology, Bispebjerg Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Sztaizel', 'Affiliation': 'Departement of Neurology and Stroke Center, University Hospital Geneva and Medical School, Geneva, Switzerland.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Brehm', 'Affiliation': 'Department of Neuroradiology, Clinic of Radiology and Nuclear Medicine, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Stippich', 'Affiliation': 'Department of Neuroradiology, Clinic of Radiology and Nuclear Medicine, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Marios', 'Initials': 'M', 'LastName': 'Psychogios', 'Affiliation': 'Department of Neuroradiology, Clinic of Radiology and Nuclear Medicine, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Lyrer', 'Affiliation': 'Department of Neurology and Stroke Center, University Hospital Basel and University of Basel, Basel, Switzerland.'}, {'ForeName': 'Stefan T', 'Initials': 'ST', 'LastName': 'Engelter', 'Affiliation': 'Department of Neurology and Stroke Center, University Hospital Basel and University of Basel, Basel, Switzerland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European stroke journal,['10.1177/2396987320921151']
1368,33072892,Effect of rosuvastatin on the concentration of each fatty acid in the fraction of free fatty acids and total lipids in human plasma: The role of cholesterol homeostasis.,"Each fatty acid (FA) or class of FAs has a different behavior in the pathologies of atherosclerosis. The aim of this study was to investigate changes in the concentration of each fatty acid in the fraction of free fatty acids (FFAs) and total lipids in human plasma after short-term therapy with rosuvastatin as a cholesterol-lowering statin drug. Six hypercholesterolemic men on a habitual diet were studied in a randomized, double-blind, and crossover process. They received 20 mg rosuvastatin or placebo in random order, each for 4 weeks and after 2 weeks of washout period, they received another medication (placebo or rosuvastatin) for another period of 4 weeks. Rosuvastatin treatment significantly decreased the absolute concentrations of saturated and monounsaturated FAs in the total FAs as well as in FFAs. Long chain polyunsaturated fatty acids with 20 and 22 carbon atoms in the molecule had no significant change in the fraction of FFAs. Rosuvastatin is directly involved in cholesterol biosynthesis and indirectly through cholesterol homeostasis in the biosynthesis of other plasma lipids. In conclusion, our findings show that rosuvastatin treatment leads to significant changes in the concentration of each fatty acid, except for long-chain polyunsaturated fatty acids in FFAs. Our observations indicate that cholesterol homeostasis through its regulatory mechanisms appears to be the main cause of changes in the concentration of each plasma fatty acid during rosuvastatin treatment. These changes can be a source of beneficial consequences, in addition to lowering low-density lipoprotein cholesterol in cardiovascular diseases.",2020,Rosuvastatin treatment significantly decreased the absolute concentrations of saturated and monounsaturated FAs in the total FAs as well as in FFAs.,"['Six hypercholesterolemic men on a habitual diet', 'human plasma']","['another medication (placebo or rosuvastatin', 'Rosuvastatin', 'rosuvastatin', 'rosuvastatin or placebo']","['fraction of FFAs', 'absolute concentrations of saturated and monounsaturated FAs']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0965129', 'cui_str': 'rosuvastatin'}]","[{'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0015688', 'cui_str': 'Unesterified fatty acid'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",6.0,0.0648233,Rosuvastatin treatment significantly decreased the absolute concentrations of saturated and monounsaturated FAs in the total FAs as well as in FFAs.,"[{'ForeName': 'Cristian I', 'Initials': 'CI', 'LastName': 'Ciucanu', 'Affiliation': 'Pharmacology and Biochemistry Department, Faculty of Medicine, University of Medicine and Pharmacy ""Victor Babes"" of Timişoara, Piaţa Eftimie Murgu 2, RO-300041, Timişoara, Romania.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Olariu', 'Affiliation': 'Pharmacology and Biochemistry Department, Faculty of Medicine, University of Medicine and Pharmacy ""Victor Babes"" of Timişoara, Piaţa Eftimie Murgu 2, RO-300041, Timişoara, Romania.'}, {'ForeName': 'Daliborca C', 'Initials': 'DC', 'LastName': 'Vlad', 'Affiliation': 'Pharmacology and Biochemistry Department, Faculty of Medicine, University of Medicine and Pharmacy ""Victor Babes"" of Timişoara, Piaţa Eftimie Murgu 2, RO-300041, Timişoara, Romania.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Dumitraşcu', 'Affiliation': 'Pharmacology and Biochemistry Department, Faculty of Medicine, University of Medicine and Pharmacy ""Victor Babes"" of Timişoara, Piaţa Eftimie Murgu 2, RO-300041, Timişoara, Romania.'}]",Biochemistry and biophysics reports,['10.1016/j.bbrep.2020.100822']
1369,33073219,"Safety and immunogenicity evaluation of recombinant BCG vaccine against respiratory syncytial virus in a randomized, double-blind, placebo-controlled phase I clinical trial.","Background


Respiratory syncytial virus (RSV) is responsible for most respiratory tract infections and hospitalizations in infants and represents a significant economic burden for public health. The development of a safe, effective, and affordable vaccine is a priority for the WHO.
Methods


We conducted a double-blinded, escalating-dose phase 1 clinical trial in healthy males aged 18-50 years to evaluate safety, tolerability, and immunogenicity of a recombinant  Mycobacterium bovis  BCG vaccine expressing the nucleoprotein of RSV (rBCG-N-hRSV). Once inclusion criteria were met, volunteers were enrolled in three cohorts in an open and successive design. Each cohort included six volunteers vaccinated with 5 × 10 3 , 5 × 10 4 , or 1 × 10 5  CFU, as well as two volunteers vaccinated with the full dose of the standard BCG vaccine. This clinical trial (clinicaltrials.gov NCT03213405) was conducted in Santiago, Chile.
Findings


The rBCG-N-RSV vaccine was safe, well-tolerated, and no serious adverse events related to the vaccine were recorded. Serum IgG-antibodies directed against  Mycobacterium  and the N-protein of RSV increased after vaccination, which were capable of neutralizing RSV  in vitro . Additionally, all volunteers displayed increased cellular response consisting of IFN-γ and IL-2 production against PPD and the N-protein, starting at day 14 and 30 post-vaccination respectively.
Interpretation


The rBCG-N-hRSV vaccine had a good safety profile and induced specific cellular and humoral responses.
Funding


This work was supported by Millennium Institute on Immunology and Immunotherapy from Chile (P09/016), FONDECYT 1190830, and FONDEF D11E1098.",2020,"Additionally, all volunteers displayed increased cellular response consisting of IFN-γ and IL-2 production against PPD and the N-protein, starting at day 14 and 30 post-vaccination respectively.
","['six volunteers vaccinated with 5\xa0×\xa010 3 , 5', 'healthy males aged 18-50 years']","['\n\n\nRespiratory syncytial virus (RSV', 'recombinant BCG vaccine', 'placebo', 'recombinant  Mycobacterium bovis  BCG vaccine expressing the nucleoprotein of RSV (rBCG-N-hRSV']","['cellular response consisting of IFN-γ and IL-2 production against PPD', 'Serum IgG-antibodies directed against  Mycobacterium  and the N-protein of RSV']","[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0035236', 'cui_str': 'Syncytial Virus, Respiratory'}, {'cui': 'C0004886', 'cui_str': 'BCG vaccine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0085957', 'cui_str': 'Attenuated Mycobacterium bovis'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0028612', 'cui_str': 'Nucleoprotein'}, {'cui': 'C0206545', 'cui_str': 'Human respiratory syncytial virus'}]","[{'cui': 'C0007634', 'cui_str': 'Cell structure'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0021756', 'cui_str': 'Interleukin-2'}, {'cui': 'C0034131', 'cui_str': 'Purified Protein Derivative of Tuberculin'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0026912', 'cui_str': 'Mycobacterium'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0035236', 'cui_str': 'Syncytial Virus, Respiratory'}]",6.0,0.471718,"Additionally, all volunteers displayed increased cellular response consisting of IFN-γ and IL-2 production against PPD and the N-protein, starting at day 14 and 30 post-vaccination respectively.
","[{'ForeName': 'Katia', 'Initials': 'K', 'LastName': 'Abarca', 'Affiliation': ""Millennium Institute on Immunology and Immunotherapy, Pontificia Universidad Católica de Chile, Av. Libertador Bernardo O'Higgins No. 340, Santiago, Chile.""}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Rey-Jurado', 'Affiliation': ""Millennium Institute on Immunology and Immunotherapy, Pontificia Universidad Católica de Chile, Av. Libertador Bernardo O'Higgins No. 340, Santiago, Chile.""}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Muñoz-Durango', 'Affiliation': ""Millennium Institute on Immunology and Immunotherapy, Pontificia Universidad Católica de Chile, Av. Libertador Bernardo O'Higgins No. 340, Santiago, Chile.""}, {'ForeName': 'Yaneisi', 'Initials': 'Y', 'LastName': 'Vázquez', 'Affiliation': ""Millennium Institute on Immunology and Immunotherapy, Pontificia Universidad Católica de Chile, Av. Libertador Bernardo O'Higgins No. 340, Santiago, Chile.""}, {'ForeName': 'Jorge A', 'Initials': 'JA', 'LastName': 'Soto', 'Affiliation': ""Millennium Institute on Immunology and Immunotherapy, Pontificia Universidad Católica de Chile, Av. Libertador Bernardo O'Higgins No. 340, Santiago, Chile.""}, {'ForeName': 'Nicolás M S', 'Initials': 'NMS', 'LastName': 'Gálvez', 'Affiliation': ""Millennium Institute on Immunology and Immunotherapy, Pontificia Universidad Católica de Chile, Av. Libertador Bernardo O'Higgins No. 340, Santiago, Chile.""}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Valdés-Ferrada', 'Affiliation': ""Millennium Institute on Immunology and Immunotherapy, Pontificia Universidad Católica de Chile, Av. Libertador Bernardo O'Higgins No. 340, Santiago, Chile.""}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Iturriaga', 'Affiliation': ""Millennium Institute on Immunology and Immunotherapy, Pontificia Universidad Católica de Chile, Av. Libertador Bernardo O'Higgins No. 340, Santiago, Chile.""}, {'ForeName': 'Marcela', 'Initials': 'M', 'LastName': 'Urzúa', 'Affiliation': ""Millennium Institute on Immunology and Immunotherapy, Pontificia Universidad Católica de Chile, Av. Libertador Bernardo O'Higgins No. 340, Santiago, Chile.""}, {'ForeName': 'Arturo', 'Initials': 'A', 'LastName': 'Borzutzky', 'Affiliation': ""Millennium Institute on Immunology and Immunotherapy, Pontificia Universidad Católica de Chile, Av. Libertador Bernardo O'Higgins No. 340, Santiago, Chile.""}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Cerda', 'Affiliation': 'Departamento de Salud Pública, Escuela de Medicina, Pontificia Universidad Católica de Chile, Santiago, Chile.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Villarroel', 'Affiliation': 'Departamento de Salud Pública, Escuela de Medicina, Pontificia Universidad Católica de Chile, Santiago, Chile.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Madrid', 'Affiliation': ""Millennium Institute on Immunology and Immunotherapy, Pontificia Universidad Católica de Chile, Av. Libertador Bernardo O'Higgins No. 340, Santiago, Chile.""}, {'ForeName': 'Pablo A', 'Initials': 'PA', 'LastName': 'González', 'Affiliation': ""Millennium Institute on Immunology and Immunotherapy, Pontificia Universidad Católica de Chile, Av. Libertador Bernardo O'Higgins No. 340, Santiago, Chile.""}, {'ForeName': 'José V', 'Initials': 'JV', 'LastName': 'González-Aramundiz', 'Affiliation': ""Millennium Institute on Immunology and Immunotherapy, Pontificia Universidad Católica de Chile, Av. Libertador Bernardo O'Higgins No. 340, Santiago, Chile.""}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Bueno', 'Affiliation': ""Millennium Institute on Immunology and Immunotherapy, Pontificia Universidad Católica de Chile, Av. Libertador Bernardo O'Higgins No. 340, Santiago, Chile.""}, {'ForeName': 'Alexis M', 'Initials': 'AM', 'LastName': 'Kalergis', 'Affiliation': ""Millennium Institute on Immunology and Immunotherapy, Pontificia Universidad Católica de Chile, Av. Libertador Bernardo O'Higgins No. 340, Santiago, Chile.""}]",EClinicalMedicine,['10.1016/j.eclinm.2020.100517']
1370,33073298,"Combination Treatment with Human Adipose Tissue Stem Cell-derived Exosomes and Fractional CO2 Laser for Acne Scars: A 12-week Prospective, Double-blind, Randomized, Split-face Study.","A variety of applications of human adipose tissue stem cell-derived exosomes have been suggested as novel cell-free therapeutic strategies in the regenerative and aesthetic medical fields. This study evaluated the clinical efficacy and safety of adipose tissue stem cell-derived exosomes as an adjuvant therapy after application of fractional CO2 laser for acne scars. A 12-week prospective, double-blind, randomized, split-face trial was performed. A total of 25 patients received 3 consecutive treatment sessions of fractional CO2 laser to the whole face, with a follow-up evaluation. Post-laser treatment regimens were applied; for each patient, one side of the face was treated with adipose tissue stem cell-derived exosomes gel and the other side was treated with control gel. Adipose tissue stem cell-derived exosomes-treated sides had achieved a significantly greater improvement than the control sides at the final follow-up visit (percentage reduction in échelle d'évaluation clinique des cicatrices d'acné (ECCA) scores: 32.5 vs 19.9%, p < 0.01). Treatment-related erythema was milder, and post-treatment downtime was shorter on the applications of human adipose tissue stem cell-derived exosomes-treated side.",2020,"Adipose tissue stem cell-derived exosomes-treated sides had achieved a significantly greater improvement than the control sides at the final follow-up visit (percentage reduction in échelle d'évaluation clinique des cicatrices d'acné (ECCA) scores: 32.5 vs 19.9%, p < 0.01).","['acne scars', 'Acne Scars', '25 patients']","['fractional CO2 laser', 'Human Adipose Tissue Stem Cell-derived Exosomes and Fractional CO2 Laser', 'adipose tissue stem cell-derived exosomes gel and the other side was treated with control gel', 'adipose tissue stem cell-derived exosomes']",['Adipose tissue stem cell'],"[{'cui': 'C0423783', 'cui_str': 'Acne scar'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0392251', 'cui_str': 'Carbon dioxide laser device'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0038250', 'cui_str': 'Stem cell'}, {'cui': 'C2350332', 'cui_str': 'Exosomes'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0038250', 'cui_str': 'Stem cell'}]",25.0,0.0249087,"Adipose tissue stem cell-derived exosomes-treated sides had achieved a significantly greater improvement than the control sides at the final follow-up visit (percentage reduction in échelle d'évaluation clinique des cicatrices d'acné (ECCA) scores: 32.5 vs 19.9%, p < 0.01).","[{'ForeName': 'Hyuck Hoon', 'Initials': 'HH', 'LastName': 'Kwon', 'Affiliation': 'Oaro Dermatology Institute, Seoul, Korea.'}, {'ForeName': 'Steven Hoseong', 'Initials': 'SH', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Joon', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Byung Chul', 'Initials': 'BC', 'LastName': 'Park', 'Affiliation': ''}, {'ForeName': 'Kui Young', 'Initials': 'KY', 'LastName': 'Park', 'Affiliation': ''}, {'ForeName': 'Jae Yoon', 'Initials': 'JY', 'LastName': 'Jung', 'Affiliation': ''}, {'ForeName': 'Youin', 'Initials': 'Y', 'LastName': 'Bae', 'Affiliation': ''}, {'ForeName': 'Gyeong-Hun', 'Initials': 'GH', 'LastName': 'Park', 'Affiliation': ''}]",Acta dermato-venereologica,['10.2340/00015555-3666']
1371,33073449,Creatine supplementation attenuates the rate of fatigue development during intermittent isometric exercise performed above end-test torque.,"NEW FINDINGS


What is the central question of this study? Does creatine supplementation augment the total torque impulse accumulated above end-test torque (IET) during severe-intensity knee-extensor exercise by attenuating the rate of decrease in peak potentiated twitch torque (PT)? What is the main finding and its importance? Creatine augmented the IET and attenuated the rate of decrease in both voluntary activation and PT during severe-intensity exercise. The IET was related to the rate of decrease in PT. These findings reveal an important role for the rates of neuromuscular fatigue development as key determinants of exercise tolerance within the severe domain.
ABSTRACT


This study investigated the effect of creatine supplementation on exercise tolerance, total torque impulse accumulated above end-test torque (total IET) and neuromuscular fatigue development of the knee extensors during severe-intensity intermittent isometric exercise. Sixteen men were randomly allocated into Creatine (n = 8, 20 g day -1  for 5 days) or Placebo (n = 8) groups and performed knee-extensor maximal voluntary contraction (MVC) testing, all-out testing to determine end-test torque (ET) and the finite torque impulse accumulated above end-test torque (IET'), and three submaximal tests at ET + 10%: (i) time to task failure without supplementation (Baseline); (ii) time to task failure after creatine or placebo supplementation; and (iii) time matched to Baseline after creatine (Creatine-Isotime) or placebo (Placebo-Isotime) supplementation. Creatine supplementation significantly increased the time to task failure (Baseline = 572 ± 144 s versus Creatine = 833 ± 221 s) and total IET (Baseline = 5761 ± 1710  N m s versus Creatine = 7878 ± 1903 N m s), but there were no significant differences within the Placebo group. The percentage change pre- to postexercise in MVC, voluntary activation, peak potentiated twitch torque and integrated EMG during MVC were not significantly different between Baseline and Creatine but were all significantly attenuated in Creatine-Isotime compared with Baseline. There were no significant differences in these variables within the placebo group. The total IET was significantly correlated with the rates of change in potentiated twitch torque peak (r = 0.83-0.87) and rate of torque development (r = -0.83 to -0.87) for the submaximal tests to task failure. These findings reveal an important role for the rates of neuromuscular fatigue development as key determinants of exercise tolerance during severe-intensity intermittent isometric exercise.",2020,Does creatine supplementation augment the total torque impulse accumulated above end-test torque (IET) during severe-intensity knee-extensor exercise by attenuating the rate of decrease in peak potentiated twitch torque (PT)?,"['7878\xa0±\xa01903', 'knee extensors during severe-intensity intermittent isometric exercise', 'n\xa0=\xa08, 20', '5761\xa0±\xa01710', 'Sixteen men']","['Creatine', 'Creatine supplementation', ""knee-extensor maximal voluntary contraction (MVC) testing, all-out testing to determine end-test torque (ET) and the finite torque impulse accumulated above end-test torque (IET'), and three submaximal tests at ET\xa0+\xa010%: (i) time to task failure without supplementation (Baseline); (ii) time to task failure after creatine or placebo supplementation; and (iii) time matched to Baseline after creatine (Creatine-Isotime) or placebo (Placebo-Isotime) supplementation"", 'placebo', 'Placebo', 'creatine supplementation']","['percentage change pre- to postexercise in MVC, voluntary activation, peak potentiated twitch torque and integrated EMG during MVC', 'rate of torque development', 'rate of decrease in PT', 'rate of fatigue development', 'time to task failure', 'potentiated twitch torque peak', 'exercise tolerance, total torque impulse accumulated above end-test torque (total IET', 'Creatine-Isotime', 'peak potentiated twitch torque (PT', 'total torque impulse accumulated above end-test torque (IET', 'total IET']","[{'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0010286', 'cui_str': 'Creatine'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0443235', 'cui_str': 'Impulse'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0231530', 'cui_str': 'Muscle twitch'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0162521', 'cui_str': 'Exercise tolerance'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0443235', 'cui_str': 'Impulse'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0010286', 'cui_str': 'Creatine'}]",16.0,0.251193,Does creatine supplementation augment the total torque impulse accumulated above end-test torque (IET) during severe-intensity knee-extensor exercise by attenuating the rate of decrease in peak potentiated twitch torque (PT)?,"[{'ForeName': 'Leonardo Henrique Perinotto', 'Initials': 'LHP', 'LastName': 'Abdalla', 'Affiliation': 'Human Performance Laboratory, São Paulo State University, Rio Claro, SP, Brazil.'}, {'ForeName': 'Ryan Michael', 'Initials': 'RM', 'LastName': 'Broxterman', 'Affiliation': 'Department of Internal Medicine, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Camila Coelho', 'Initials': 'CC', 'LastName': 'Greco', 'Affiliation': 'Human Performance Laboratory, São Paulo State University, Rio Claro, SP, Brazil.'}, {'ForeName': 'Benedito Sérgio', 'Initials': 'BS', 'LastName': 'Denadai', 'Affiliation': 'Human Performance Laboratory, São Paulo State University, Rio Claro, SP, Brazil.'}]",Experimental physiology,['10.1113/EP088910']
1372,33073501,Histologic Observation and Significance of Sympathetic Nerve Fiber Distribution on Human Cervical Ligamentum Flavum.,"OBJECTIVE


To study the distribution of sympathetic nerves of the ligamentum flavum (LF), confirm its existence by histological observation and nuclear magnetic resonance spectroscopy, and analyze the relationship between sympathetic nerve fibers and the biomechanical structure of the LF.
METHODS


Randomly controlled scientific research selected 15 cases of posterior surgery in the affiliated hospital of Qingdao University from January 2013 to December 2019. The average age was 67.5 ± 14.5 years old, eight males and seven females. The LF specimens (completely separated fresh tissue) of different segments (C 3-7  ) were taken during the operation. Two pages of LF specimens on the left and right sides of the same segment are randomly allocated by the pairing method for formalin fixation and cryopreservation in liquid nitrogen. LF specimens extracted from seven other adult cadaver specimens (average age at death of about 56.8 ± 4.0 years, three males and four females) were used as a control group; together with formalin- fixed specimens obtained during surgery, 3D slices were given layer by layer. The distribution of sympathetic nerves in different parts of the LF was analyzed by glyoxylic acid-induced biological monoamine fluorescent technique (SPG) and hematoxylin-eosin (HE) staining. Fifteen liquid nitrogen storage specimens were divided into the back of the LF and the spinal canal through frozen sections, and were analyzed by nuclear magnetic resonance spectroscopy-hydrogen spectrum ( 1  H -NMR) for neurotransmitters and neurometabolites.
RESULTS


There were type C sympathetic nerve fibers in the LF, which were divided into linear shape (α) and wave shape (β). Experimental group (χ 2  = 1.705, P > 0.05) and control group (χ 2  = 0.879, P > 0.05) can detect no difference in fluorescence units. Nerve fiber transmitter metabolites choline (Cho), creator (Cr), γ-aminobutyric acid (GABA) also indicate that the sympathetic nerve is present in the LF. LF sympathetic nerve fibers were mainly distributed in the proximal spinal canal surface, nerve fibers on the medial belt (area II) were fewer than the lateral belt (area I) (W = 210, P < 0.05). The  1  HNMR spectrum of LF spinal canal PG / Cho (t = 8.721, P < 0.05), GABA (t = 16.01, P < 0.05) value increased, lactic acid (Lac) / Cr (t = 4.213, P < 0.05), Cho / Cr (t = 2.402, P < 0.05) value decreased, indicating that nerve fibers are actively metabolized on the surface of the spinal canal, mainly distributed in tube surface. βtype fibers were more often distributed around microvessels. A small amount of α type fibers went next to the vascular structures, while α type fibers and β type fibers go cross within LF. Two patients with vertebral artery dissection had no recurrence of sympathetic symptoms within a total of 12 follow-ups 2 years after discharge.
CONCLUSIONS


There are many sympathetic nerve fibers distributed on LF, and their distribution may be correlated with histological and mechanical characteristics of LF. It may also be the anatomical basis of cervical vertigo.",2020,"Two patients with vertebral artery dissection had no recurrence of sympathetic symptoms within a total of 12 follow-ups 2 years after discharge.
","['Randomly controlled scientific research selected 15 cases of posterior surgery in the affiliated hospital of Qingdao University from January 2013 to December 2019', 'The average age was 67.5\u2009±\u200914.5\u2009years old, eight males and seven females', 'LF specimens extracted from seven other adult cadaver specimens (average age at death of about 56.8 ± 4.0 years, three males and four females', 'Fifteen liquid nitrogen storage specimens']","['pairing method for formalin fixation and cryopreservation in liquid nitrogen', 'ligamentum flavum (LF']","['recurrence of sympathetic symptoms', 'GABA', 'LF sympathetic nerve fibers', 'lactic acid (Lac) ', 'fluorescence units', 'Nerve fiber transmitter metabolites choline (Cho), creator (Cr), γ-aminobutyric acid (GABA']","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0206327', 'cui_str': 'Structure of ligamentum flavum'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0006629', 'cui_str': 'Cadaver'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0260055', 'cui_str': 'Liquid nitrogen'}, {'cui': 'C1698986', 'cui_str': 'Storage'}]","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0949307', 'cui_str': 'Formalin'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0010405', 'cui_str': 'Cryopreservation'}, {'cui': 'C0260055', 'cui_str': 'Liquid nitrogen'}, {'cui': 'C0206327', 'cui_str': 'Structure of ligamentum flavum'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0016904', 'cui_str': 'Gamma-aminobutyric acid'}, {'cui': 'C0206327', 'cui_str': 'Structure of ligamentum flavum'}, {'cui': 'C0459521', 'cui_str': 'Sympathetic nerve structure'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0064582', 'cui_str': 'lactic acid'}, {'cui': 'C0016315', 'cui_str': 'Fluorescence'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0027749', 'cui_str': 'Nerve fiber'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0008405', 'cui_str': 'Choline'}]",2.0,0.0204258,"Two patients with vertebral artery dissection had no recurrence of sympathetic symptoms within a total of 12 follow-ups 2 years after discharge.
","[{'ForeName': 'Xiaolin', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Department of Orthopedics, The Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Orthopedics, The Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Guoqing', 'Initials': 'G', 'LastName': 'Zhang', 'Affiliation': 'Department of Orthopedics, The Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Zhu', 'Initials': 'Z', 'LastName': 'Guo', 'Affiliation': 'Department of Orthopedics, The Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Orthopedics, The Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Ronghuan', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Department of Orthopedics, The Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Hongfei', 'Initials': 'H', 'LastName': 'Xiang', 'Affiliation': 'Department of Orthopedics, The Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Bohua', 'Initials': 'B', 'LastName': 'Chen', 'Affiliation': 'Department of Orthopedics, The Affiliated Hospital of Qingdao University, Qingdao, China.'}]",Orthopaedic surgery,['10.1111/os.12802']
1373,33073523,Stratified Treatment of Heart Failure with preserved Ejection Fraction: rationale and design of the STADIA-HFpEF trial.,"AIMS


High myocardial stiffness in heart failure with preserved ejection fraction (HFpEF) is attributed to comorbidity-induced structural and functional remodelling through inflammation and oxidative stress affecting coronary microvascular endothelial cells and cardiomyocytes, which augments interstitial fibrosis and cardiomyocyte stiffness. In murine and human HFpEF myocardium, sodium glucose co-transporter 2 (SGLT2) inhibition ameliorates cardiac microvascular endothelial cell and cardiomyocyte oxidative stress, while enhancing myocardial protein kinase G activity and lowering titin-based cardiomyocyte stiffness. Failure of previous HFpEF outcome trials refocuses attention to improving pathophysiological insight and trial design with better phenotyping of patients and matching of therapeutic targets to prevailing pathogenetic mechanisms. SGLT2 inhibition could represent a viable therapeutic option especially in HFpEF patients in whom high diastolic left ventricular (LV) stiffness is predominantly caused by elevated cardiomyocyte stiffness and associated endothelial dysfunction, whereas HFpEF patients with extensive myocardial fibrosis might be less responsive. This study aims to investigate a stratified treatment approach, using dapagliflozin in heart failure patients with preserved ejection fraction without evidence of significant myocardial fibrosis.
METHODS AND RESULTS


The Stratified Treatment to Ameliorate DIAstolic left ventricular stiffness in early Heart Failure with preserved Ejection Fraction (STADIA-HFpEF) is a Phase II, randomized, 2 × 2 crossover trial, evaluating the efficacy of 13 weeks of treatment with dapagliflozin 10 mg od in 26 patients with HFpEF, with normal cardiac magnetic resonance imaging-derived extracellular volume. The co-primary endpoint is echocardiographically derived change in E/e'/LV end-diastolic volume index and change in mean LV e'.
CONCLUSIONS


The STADIA-HFpEF trial will be the first study to evaluate the direct effects of dapagliflozin on amelioration of LV stiffness, using histological phenotyping to discern early HFpEF.",2020,"The Stratified Treatment to Ameliorate DIAstolic left ventricular stiffness in early Heart Failure with preserved Ejection Fraction (STADIA-HFpEF) is a Phase II, randomized, 2 × 2 crossover trial, evaluating the efficacy of 13 weeks of treatment with dapagliflozin 10 ","['26 patients with HFpEF, with normal cardiac magnetic resonance imaging-derived extracellular volume', 'heart failure patients with preserved ejection fraction without evidence of significant myocardial fibrosis', 'heart failure with preserved ejection fraction (HFpEF', 'HFpEF patients with extensive myocardial fibrosis']","['sodium glucose co-transporter 2 (SGLT2) inhibition', 'dapagliflozin 10', 'SGLT2', 'dapagliflozin']","[""echocardiographically derived change in E/e'/LV end-diastolic volume index and change in mean LV e""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2960127', 'cui_str': 'Heart failure with normal ejection fraction'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0521119', 'cui_str': 'Extracellular'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0151654', 'cui_str': 'Myocardial fibrosis'}, {'cui': 'C0205231', 'cui_str': 'Extensive'}]","[{'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0598849', 'cui_str': 'Co-Transporters'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0042509', 'cui_str': 'Ventricular End-Diastolic Volume'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}]",26.0,0.0446211,"The Stratified Treatment to Ameliorate DIAstolic left ventricular stiffness in early Heart Failure with preserved Ejection Fraction (STADIA-HFpEF) is a Phase II, randomized, 2 × 2 crossover trial, evaluating the efficacy of 13 weeks of treatment with dapagliflozin 10 ","[{'ForeName': 'Mariëlle', 'Initials': 'M', 'LastName': 'Scheffer', 'Affiliation': 'Department of Cardiology, OLVG, Oosterpark 9, Amsterdam, 1091 AC, The Netherlands.'}, {'ForeName': 'Annet', 'Initials': 'A', 'LastName': 'Driessen-Waaijer', 'Affiliation': 'Department of Radiology, OLVG, Amsterdam, The Netherlands.'}, {'ForeName': 'Nazha', 'Initials': 'N', 'LastName': 'Hamdani', 'Affiliation': 'Department of Molecular and Experimental Cardiology, Ruhr University Bochum, Bochum, Germany.'}, {'ForeName': 'Jochem W D', 'Initials': 'JWD', 'LastName': 'Landzaat', 'Affiliation': 'Department of Cardiology, OLVG, Oosterpark 9, Amsterdam, 1091 AC, The Netherlands.'}, {'ForeName': 'Nini H', 'Initials': 'NH', 'LastName': 'Jonkman', 'Affiliation': 'Department of Research and Epidemiology, OLVG, Amsterdam, The Netherlands.'}, {'ForeName': 'Walter J', 'Initials': 'WJ', 'LastName': 'Paulus', 'Affiliation': 'Department of Physiology, Institute for Cardiovascular Research VU, VU University Medical Center Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Loek', 'Initials': 'L', 'LastName': 'van Heerebeek', 'Affiliation': 'Department of Cardiology, OLVG, Oosterpark 9, Amsterdam, 1091 AC, The Netherlands.'}]",ESC heart failure,['10.1002/ehf2.13055']
1374,33073594,Testing the Effects of Hookah Tobacco Social Media Risk Communication Messages Among Young Adults.,"BACKGROUND


Hookah tobacco is commonly used among young adults, and use is driven in part by widespread misperceptions about risks. Social media use, particularly Instagram, is prominent in this population and exposure to commercial and user-generated content promoting hookah commonly occurs.
AIMS


This study tested the effects of hookah tobacco risk messaging for delivery via Instagram as a strategy to offset exposure to content promoting hookah use among young adults.
METHOD


Young adult hookah smokers were recruited online for a 2 × 3 between-subjects experiment ( n  = 601). Participants completed preexposure measures and were randomized to view hookah tobacco Instagram ads (commercial or user generated) with risk messages (none, risk education, or graphic risk). Stimuli were presented as a simulated Instagram feed. After viewing the stimuli, participants completed postexposure outcome measures.
RESULTS


There was a statistically significant main effect of risk message type but no significant main effect of Instagram ad type or risk message type by ad type interactions. Exposure to the graphic risk and risk education messages were associated with lower intentions to engage with hookah tobacco ads on Instagram. Graphic risk and risk education messages produced greater negative emotional response and the graphic messages increased motivation to quit compared with Instagram ads alone.
DISCUSSION


Findings provide preliminary evidence that hookah tobacco risk messages delivered via Instagram can offset the influence of content promoting the use of hookah tobacco.
CONCLUSION


This study represents an example of risk message testing and the results suggest the messages warrant further testing via social media delivery.",2020,"Graphic risk and risk education messages produced greater negative emotional response and the graphic messages increased motivation to quit compared with Instagram ads alone.
","['Young Adults', 'young adults', 'Young adult hookah smokers were recruited online for a 2 × 3 between-subjects experiment ( n  = 601']","['hookah tobacco risk messaging', 'view hookah tobacco Instagram ads (commercial or user generated) with risk messages (none, risk education, or graphic risk', 'Hookah Tobacco Social Media Risk Communication Messages']","['negative emotional response', 'motivation to quit']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C4302493', 'cui_str': 'Hookah pipe'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C4505132', 'cui_str': 'Hookah Tobacco'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0009452', 'cui_str': 'Communication'}]","[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}]",,0.0402818,"Graphic risk and risk education messages produced greater negative emotional response and the graphic messages increased motivation to quit compared with Instagram ads alone.
","[{'ForeName': 'Andrea C', 'Initials': 'AC', 'LastName': 'Johnson', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Darren', 'Initials': 'D', 'LastName': 'Mays', 'Affiliation': 'The Ohio State University, Columbus, OH, USA.'}]",Health education & behavior : the official publication of the Society for Public Health Education,['10.1177/1090198120963104']
1375,33073598,Offering disinclined people the choice between different screening appointments: a randomised online survey.,"OBJECTIVES


An invitation to cancer screening with a single (fixed) appointment time has been shown to be a more effective way at increasing uptake compared with an invitation with an open (unscheduled) appointment. The present study tested whether offering more than one fixed appointment could further enhance this effect or be detrimental to people's intention.
DESIGN


Experimental online hypothetical vignette survey.
METHODS


1,908 respondents who stated that they did not intend to participate in Bowel Scope Screening (BSS) were offered either one, two, four or six hypothetical fixed BSS appointments (all of which covered the same time of day to control for individual preferences).
RESULTS


Participants who were given more than one appointment to choose from were less likely to intend to book an appointment despite multiple appointments being perceived as more convenient.
CONCLUSIONS


These results suggest that when it comes to offering people appointments for cancer screening, less (choice) is more, at least if alternatives fail to serve an inherent preference.",2020,"The present study tested whether offering more than one fixed appointment could further enhance this effect or be detrimental to people's intention.
","['1,908 respondents who stated that they did not intend to participate in Bowel Scope Screening (BSS']",[],[],"[{'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}]",[],[],1908.0,0.0413563,"The present study tested whether offering more than one fixed appointment could further enhance this effect or be detrimental to people's intention.
","[{'ForeName': 'Sandro Tiziano', 'Initials': 'ST', 'LastName': 'Stoffel', 'Affiliation': 'Research Department of Behavioural Science and Health, University College London, London, UK.'}, {'ForeName': 'Yasemin', 'Initials': 'Y', 'LastName': 'Hirst', 'Affiliation': 'Research Department of Behavioural Science and Health, University College London, London, UK.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Ghanouni', 'Affiliation': 'Research Department of Behavioural Science and Health, University College London, London, UK.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Waller', 'Affiliation': ""Cancer Prevention Group, School of Cancer and Pharmaceutical Sciences, King's College London, London, UK.""}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'von Wagner', 'Affiliation': 'Research Department of Behavioural Science and Health, University College London, London, UK.'}]",Psychology & health,['10.1080/08870446.2020.1834559']
1376,33073622,A Prospective and Retrospective Clinical Controlled Observation of Chinese Herbal Decoction (SMLJ01) for Type 1 Gastric Neuroendocrine Tumors.,"INTRODUCTION


Type 1 gastric neuroendocrine tumors (g-NETs) have a good prognosis but a high recurrence rate.
AIM


To observe the clinical efficacy of the treatment of type 1 g-NETs with the Chinese herbal decoction SMLJ01.
MATERIALS AND METHODS


A prospective and retrospective, clinical, controlled observation was conducted in 4 Chinese centers from 2012 to 2019. Patients with type 1 g-NETs were nonrandomly divided into treatment and control groups after endoscopic treatment based on herbal treatment administered according to their wishes. The treatment group received oral SMLJ01, with follow-up every 6 to 12 months, while the control group received follow-up alone. Patient follow-up (via telephone) from 2012 to 2017 was mainly retrospective. All patients after 2017 were followed prospectively. The recurrence times and rates were compared after treatment for at least 6 months. Symptom improvements were evaluated in the treatment group. The follow-up ended on October 31, 2019.
RESULTS


During a median follow-up of 22 months (range: 2-86 months), the survival rate was 100%, and no metastases occurred. Twenty-one of the 82 treated patients (25.6%) had recurrence after a median of 22 months, and 22 of the 54 control patients (40.7%) had recurrence after a median of 8 months ( P  = .063). The Kaplan-Meier curve analysis showed that the patients in the treatment group had a significantly longer median recurrence-free survival (RFS) time than those in the control group ( P  = .001). The risk of recurrence in the treatment group was 0.38 relative to that in the control group (95% CI: 0.20-0.70). The symptom score of the patients after taking Chinese medicine was 19.5 (10.3, 28.0), which was significantly lower than before treatment (31.5 (19.3, 38.0)). The difference was statistically significant ( P  < .01).
CONCLUSION


SMLJ01, with the effects of soothing the liver, strengthening the spleen, increasing acid and harmonizing the stomach, may help reduce the recurrence rate, relieve symptoms and prolong the recurrence time in patients with type 1 g-NETs and is worthy of evaluation with further randomized research with large sample sizes and longer follow-up periods.",2020,The Kaplan-Meier curve analysis showed that the patients in the treatment group had a significantly longer median recurrence-free survival (RFS) time than those in the control group ( P  = .001).,"['4 Chinese centers from 2012 to 2019', 'Patients with type 1 g-NETs', 'Type 1 Gastric Neuroendocrine Tumors', 'All patients after 2017 were followed prospectively']","['Chinese herbal decoction SMLJ01', 'oral SMLJ01', 'Chinese Herbal Decoction (SMLJ01']","['Symptom improvements', 'risk of recurrence', 'recurrence times and rates', 'symptom score', 'recurrence', 'median recurrence-free survival (RFS) time', 'survival rate']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0206754', 'cui_str': 'Neuroendocrine tumor'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0376667', 'cui_str': 'Herbals'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C2919551', 'cui_str': 'Duration of recurrence-free survival'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",,0.0340016,The Kaplan-Meier curve analysis showed that the patients in the treatment group had a significantly longer median recurrence-free survival (RFS) time than those in the control group ( P  = .001).,"[{'ForeName': 'Yingying', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Deng', 'Initials': 'D', 'LastName': 'Han', 'Affiliation': 'Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Jiqing', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Cancer Hospital Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Haiyi', 'Initials': 'H', 'LastName': 'Hu', 'Affiliation': 'Beijing Friendship Hospital, Capital Medical University; National Clinical Research Center for Digestive Diseases; Beijing Digestive Disease Center; Beijing Key Laboratory for Precancerous Lesion of Digestive Diseases, Beijing, China.'}, {'ForeName': 'Dou', 'Initials': 'D', 'LastName': 'Dou', 'Affiliation': 'Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Yuan', 'Affiliation': 'Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Zhirong', 'Initials': 'Z', 'LastName': 'Qi', 'Affiliation': 'China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Xinran', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Jixi', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Luo', 'Affiliation': 'China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Huangying', 'Initials': 'H', 'LastName': 'Tan', 'Affiliation': 'China-Japan Friendship Hospital, Beijing, China.'}]",Integrative cancer therapies,['10.1177/1534735420958488']
1377,33073733,Mindfulness Training to Improve Nurse Clinical Performance: A Pilot Study.,"Health care errors are a national concern. Although considerable attention has been placed on reducing errors since a 2000 Institute of Medicine report, adverse events persist. The purpose of this pilot study was to evaluate the effect of mindfulness training, employing the standardized approach of an eight-week mindfulness-based, stress reduction program on reduction of nurse errors in simulated clinical scenarios. An experimental, pre- and post-test control group design was employed with 20 staff nurses and senior nursing students. Although not statistically significant, there were numerical differences in clinical performance scores from baseline when comparing mindfulness and control groups immediately following mindfulness training and after three months. A number of benefits of mindfulness training, such as improved listening skills, were identified. This pilot study supports the benefits of mindfulness training in improving nurse clinical performance and illustrates a novel approach to employ in future research.",2020,"Although not statistically significant, there were numerical differences in clinical performance scores from baseline when comparing mindfulness and control groups immediately following mindfulness training and after three months.",['20 staff nurses and senior nursing students'],"['mindfulness training', 'Mindfulness Training', 'mindfulness training, employing the standardized approach of an eight-week mindfulness-based, stress reduction program']",['clinical performance scores'],"[{'cui': 'C0728982', 'cui_str': 'Staff nurse'}, {'cui': 'C0038496', 'cui_str': 'Student nurse'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0112732,"Although not statistically significant, there were numerical differences in clinical performance scores from baseline when comparing mindfulness and control groups immediately following mindfulness training and after three months.","[{'ForeName': 'Janice M', 'Initials': 'JM', 'LastName': 'Zeller', 'Affiliation': 'School of Nursing and Health Sciences, North Park University, Chicago, IL, USA.'}, {'ForeName': 'Angela M', 'Initials': 'AM', 'LastName': 'Johnson', 'Affiliation': 'Rush Cancer Center, Rush University Medical Center, Chicago, IL, USA.'}, {'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'Hoffman', 'Affiliation': 'Department of Preventative Medicine, Rush University Medical Center, Chicago, IL, USA.'}, {'ForeName': 'Ruby L', 'Initials': 'RL', 'LastName': 'Hoyem', 'Affiliation': 'American Association of Nurse Anesthetists, Park Ridge, IL, USA.'}, {'ForeName': 'Michelle B', 'Initials': 'MB', 'LastName': 'Alexander', 'Affiliation': 'Valencia College, Orlando, FL, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Yudkowsky', 'Affiliation': 'Department of Medical Education, College of Medicine, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Frank D', 'Initials': 'FD', 'LastName': 'Hicks', 'Affiliation': 'Department of Adult Health and Gerontological Nursing, College of Nursing, Rush University College of Nursing, Chicago, IL, USA.'}]",Western journal of nursing research,['10.1177/0193945920964938']
1378,33073745,"CALMA, a Mobile Health Application, as an Accessory to Therapy for Reduction of Suicidal and Non-Suicidal Self-Injured Behaviors: A Pilot Cluster Randomized Controlled Trial.","The present study was aim to evaluate the acceptability and preliminary effectiveness of a mobile-health application, CALMA, based on dialectical behavioral therapy skills. CALMA was proposed as an adjunct to therapy for the reduction of non-suicidal and suicidal self-injury behaviors. A parallel design was used to compare the intervention group (DBT + CALMA) and the comparison group (DBT). Patients were randomized based on their groups following a randomized cluster design. After treatment, patients completed a follow-up assessment four weeks later. Each cluster was represented by a different DBT Skills Training Group offered weekly at FORO Foundation for Mental Health. Six DBT Skills Training groups were randomized to the intervention or comparison group. Twenty-one individuals met inclusion criteria and eighteen were included in the analysis. Acceptability was measured with the User Experience Questionnaire short version (UEQ-s) and preliminary efficacy with the Self-injurious thoughts and behaviors interview (SITBI). CALMA shows good acceptability to be used as an adjunct to therapy specific to the reduction of suicidal and non-suicidal self-directed violence. Evidence for preliminary efficacy included a high probability of decreased in more behaviors evaluated with the SITBI pre- and post-intervention for the group that received CALMA as compared to the comparison group. Our study provides initial evidence for the effectiveness and acceptability of CALMA. Future studies scaling up this intervention in a larger number of participants are necessary. CALMA may be especially useful in low and middle-income Latin American countries to improve access to evidence-based interventions openly available in Spanish and free to download. Highlights CALMA is a DBT-based app aimed to reduce non-suicidal and suicidal self-directed violence. The app showed good acceptability by users A high probability of decrease in suicidal ideation, suicidal plan, suicidal gesture, thoughts about NSSI and NSSI pre- and post-intervention was observed.",2020,"The app showed good acceptability by users A high probability of decrease in suicidal ideation, suicidal plan, suicidal gesture, thoughts about NSSI and NSSI pre- and post-intervention was observed.",['Twenty-one individuals met inclusion criteria and eighteen were included in the analysis'],"['mobile-health application, CALMA', 'CALMA', 'intervention group (DBT\u2009+\u2009CALMA']","['suicidal ideation, suicidal plan, suicidal gesture, thoughts about NSSI and NSSI pre- and post-intervention', 'User Experience Questionnaire short version (UEQ-s) and preliminary efficacy with the Self-injurious thoughts and behaviors interview (SITBI', 'Acceptability']","[{'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3472347', 'cui_str': 'Digital breast tomosynthesis'}]","[{'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0424001', 'cui_str': 'Planning suicide'}, {'cui': 'C0438696', 'cui_str': 'Suicidal'}, {'cui': 'C0017510', 'cui_str': 'Gestures'}, {'cui': 'C0039869', 'cui_str': 'Thinking'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0439611', 'cui_str': 'Preliminary'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",,0.0669652,"The app showed good acceptability by users A high probability of decrease in suicidal ideation, suicidal plan, suicidal gesture, thoughts about NSSI and NSSI pre- and post-intervention was observed.","[{'ForeName': 'Demián E', 'Initials': 'DE', 'LastName': 'Rodante', 'Affiliation': ''}, {'ForeName': 'Marcela I', 'Initials': 'MI', 'LastName': 'Kaplan', 'Affiliation': ''}, {'ForeName': 'Ramiro', 'Initials': 'R', 'LastName': 'Olivera Fedi', 'Affiliation': ''}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Gagliesi', 'Affiliation': ''}, {'ForeName': 'Agustina', 'Initials': 'A', 'LastName': 'Pascali', 'Affiliation': ''}, {'ForeName': 'Paula S', 'Initials': 'PS', 'LastName': 'José Quintero', 'Affiliation': ''}, {'ForeName': 'Emilio J', 'Initials': 'EJ', 'LastName': 'Compte', 'Affiliation': ''}, {'ForeName': 'Ana I', 'Initials': 'AI', 'LastName': 'Perez', 'Affiliation': ''}, {'ForeName': 'Melina', 'Initials': 'M', 'LastName': 'Weinstein', 'Affiliation': ''}, {'ForeName': 'Luciana C', 'Initials': 'LC', 'LastName': 'Chiapella', 'Affiliation': ''}, {'ForeName': 'Federico M', 'Initials': 'FM', 'LastName': 'Daray', 'Affiliation': ''}]",Archives of suicide research : official journal of the International Academy for Suicide Research,['10.1080/13811118.2020.1834476']
1379,33073779,Effects of a Newly Developed Experimental Bleaching Agent on Tooth Color and Shear Bond Strength of Composite Resins.,"PURPOSE


To evaluate the bleaching efficacy and shear bond strength (SBS) of composite restorations performed immediately after bleaching with a newly developed experimental bleaching agent, including 6% hydrogen peroxide (HP), titanium dioxide (TiO2), and/or chitosan (CS).
MATERIALS AND METHODS


We randomly divided 132 maxillary anterior teeth into 2 study groups, 60 teeth for color analysis and 72 teeth for the SBS test. For color analysis, teeth were divided into 5 subgroups. For SBS analysis, teeth were divided into 6 subgroups according to bleaching agent: group C (control): no bleaching; group 35HP: whiteness 35% HP; group 6HP: 6% HP; group HPC: 6% HP+CS; group HPT: 6% HP+TiO2; group HPTC: 6% HP+ TiO2+CS. The teeth were measured with a spectrophotometer before and 24 h after the bleaching, and calculated with the CIEDE2000 formula. SBS test was evaluated in composite restorations immediately after bleaching, using a universal testing machine. Statistical analysis was performed using ANOVA.
RESULTS


The highest ∆E00 values were observed in group 35HP (4.2 ± 1.2); the lowest value was observed in group 6HP (1.7 ± 0.6) (p < 0.05). The values for groups HPC and HPT were similar to each other and significantly lower than the value for 35HP (p < 0.05 and p > 0.05, respectively). Group HPTC was similar to 35 HP (p > 0.05). For SBS, all groups except those containing chitosan showed significantly decreased bond strength compared to the control (p < 0.05), while groups HPC and HPTC had values similar to the control (p > 0.05). Group C (28.02 ± 6.81) had the highest value, while group 35HP (17.02 ± 7.79) had the lowest SBS value.
CONCLUSION


With the newly developed agent, the bond strength immediately after bleaching was found to be similar to the control group. Its bleaching efficacy was similar to that of routinely used bleaching agents.",2020,"For SBS, all groups except those containing chitosan showed significantly decreased bond strength compared to the control (p < 0.05), while groups HPC and HPTC had values similar to the control (p > 0.05).","['We randomly divided 132 maxillary anterior teeth into 2 study groups, 60 teeth for color analysis and 72 teeth for the SBS test']","['bleaching agent: group C (control): no bleaching; group 35HP: whiteness 35% HP; group 6HP: 6% HP; group HPC: 6% HP+CS; group HPT: 6% HP+TiO2; group HPTC: 6% HP+ TiO2+CS', 'hydrogen peroxide (HP), titanium dioxide (TiO2), and/or chitosan (CS']","['SBS test', 'bleaching efficacy and shear bond strength (SBS', 'highest ∆E00 values', 'bond strength', 'Tooth Color and Shear Bond Strength of Composite Resins']","[{'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0332286', 'cui_str': 'Into'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C2936259', 'cui_str': 'Whitening Agents'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0020281', 'cui_str': 'Hydrogen Peroxide'}, {'cui': 'C0018956', 'cui_str': 'Hematopoietic stem cell'}, {'cui': 'C0020275', 'cui_str': 'Hydrogen'}, {'cui': 'C0076733', 'cui_str': 'titanium dioxide'}, {'cui': 'C0162969', 'cui_str': 'Chitosan'}]","[{'cui': 'C0175735', 'cui_str': 'Scissors'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0303749', 'cui_str': 'Bleach'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0475833', 'cui_str': 'Tooth color'}, {'cui': 'C0009570', 'cui_str': 'Composite Resins'}]",132.0,0.0119165,"For SBS, all groups except those containing chitosan showed significantly decreased bond strength compared to the control (p < 0.05), while groups HPC and HPTC had values similar to the control (p > 0.05).","[{'ForeName': 'Derya', 'Initials': 'D', 'LastName': 'Surmelioglu', 'Affiliation': ''}, {'ForeName': 'Sevim', 'Initials': 'S', 'LastName': 'Atilan Yavuz', 'Affiliation': ''}, {'ForeName': 'Halime', 'Initials': 'H', 'LastName': 'Kolsuz Ozcetin', 'Affiliation': ''}, {'ForeName': 'Zeyneb Merve', 'Initials': 'ZM', 'LastName': 'Özdemir', 'Affiliation': ''}, {'ForeName': 'Ugur', 'Initials': 'U', 'LastName': 'Aydin', 'Affiliation': ''}]",The journal of adhesive dentistry,['10.3290/j.jad.a45178']
1380,32673591,Effects of 4- and 6-h Time-Restricted Feeding on Weight and Cardiometabolic Health: A Randomized Controlled Trial in Adults with Obesity.,"Time-restricted feeding (TRF) regimens have grown in popularity; however, very few studies have examined their weight-loss efficacy. We conducted the first human trial (Clinicaltrials.gov NCT03867773) to compare the effects of two popular forms of TRF (4 and 6 h) on body weight and cardiometabolic risk factors. Adults with obesity were randomized to 4-h TRF (eating only between 3 and 7 p.m.), 6-h TRF (eating only between 1 and 7 p.m.), or a control group (no meal timing restrictions). After 8 weeks, 4- and 6-h TRF produced comparable reductions in body weight (∼3%), insulin resistance, and oxidative stress, versus controls. Energy intake was reduced by ∼550 kcal/day in both TRF groups, without calorie counting. These findings suggest that 4- and 6-h TRF induce mild reductions in body weight over 8 weeks and show promise as interventions for weight loss. These diets may also improve some aspects of cardiometabolic health.",2020,"After 8 weeks, 4- and 6-h TRF produced comparable reductions in body weight (∼3%), insulin resistance, and oxidative stress, versus controls.","['Adults with Obesity', 'Adults with obesity']","['4-h TRF', 'TRF', '4- and 6-h Time-Restricted Feeding', 'control group (no meal timing restrictions']","['body weight (∼3%), insulin resistance, and oxidative stress', 'body weight', 'Energy intake', 'Weight and Cardiometabolic Health', 'body weight and cardiometabolic risk factors']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C4704883', 'cui_str': 'Time Restricted Feeding'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0449243', 'cui_str': 'Timing'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}]",,0.0381324,"After 8 weeks, 4- and 6-h TRF produced comparable reductions in body weight (∼3%), insulin resistance, and oxidative stress, versus controls.","[{'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Cienfuegos', 'Affiliation': 'Department of Kinesiology and Nutrition, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Kelsey', 'Initials': 'K', 'LastName': 'Gabel', 'Affiliation': 'Department of Kinesiology and Nutrition, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Faiza', 'Initials': 'F', 'LastName': 'Kalam', 'Affiliation': 'Department of Kinesiology and Nutrition, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Ezpeleta', 'Affiliation': 'Department of Kinesiology and Nutrition, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Wiseman', 'Affiliation': 'Department of Kinesiology and Nutrition, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Vasiliki', 'Initials': 'V', 'LastName': 'Pavlou', 'Affiliation': 'Department of Kinesiology and Nutrition, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Shuhao', 'Initials': 'S', 'LastName': 'Lin', 'Affiliation': 'Department of Kinesiology and Nutrition, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Manoela Lima', 'Initials': 'ML', 'LastName': 'Oliveira', 'Affiliation': 'Department of Kinesiology and Nutrition, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Krista A', 'Initials': 'KA', 'LastName': 'Varady', 'Affiliation': 'Department of Kinesiology and Nutrition, University of Illinois at Chicago, Chicago, IL, USA. Electronic address: varady@uic.edu.'}]",Cell metabolism,['10.1016/j.cmet.2020.06.018']
1381,32679537,Blood pressure postpartum (BP 2 ) RCT protocol: Follow-up and lifestyle behaviour change strategies in the first 12 months after hypertensive pregnancy.,"OBJECTIVES


Women who had hypertensive disorders of pregnancy (HDP) are twice as likely to experience maternal cardiovascular disease later in life. The primary aim of this study (BP 2 ) is to compare outcomes of 3 different management strategies, including lifestyle behaviour change (LBC), in the first 12 months postpartum in women who had HDP in their preceding pregnancy. Secondary aims include assessing the effects on other cardiometabolic parameters.
STUDY DESIGN


Three-arm multicentre randomised trial in metropolitan Australian hospitals, (registration: ACTRN12618002004246) target sample size 480. Participants are randomised to one of three groups: 1) Optimised usual care: information package and family doctor follow-up 6 months postpartum 2) Brief intervention: information package as per group 1, plus assessment and brief LBC counselling at a specialised clinic with an obstetric physician and dietitian 6 months postpartum 3) Extended intervention: as per group 2 plus enrolment into a 6 month telephone-based LBC program from 6 to 12 months postpartum. All women have an outcome assessment at 12 months.
MAIN OUTCOME MEASURES


Primary outcomes: (a) BP change or (b) weight change and/or waist circumference change.
SECONDARY OUTCOMES


maternal health-related quality of life, engagement and retention in LBC program, biochemical markers, vascular function testing, infant weight trajectory, incremental cost-effectiveness ratios. The study is powered to detect a 4 mmHg difference in systolic BP between groups, or a 4 kg weight loss difference/2cm waist circumference change.
CONCLUSIONS


BP 2  will provide evidence regarding the feasibility and effectiveness of postpartum LBC interventions and structured clinical follow-up in improving cardiovascular health markers after HDP.",2020,Participants are randomised to one of three groups: 1) Optimised usual care: information package and family doctor follow-up 6 months postpartum 2),"['women who had HDP in their preceding pregnancy', 'Three-arm multicentre randomised trial in metropolitan Australian hospitals, (registration: ACTRN12618002004246) target sample size 480', 'Women who had hypertensive disorders of pregnancy (HDP']","['LBC counselling at a specialised clinic with an obstetric physician and dietitian 6\xa0months postpartum 3) Extended intervention: as per group 2 plus enrolment into a 6\xa0month telephone-based LBC program', 'Optimised usual care: information package and family doctor follow-up 6\xa0months postpartum 2']","['Blood pressure postpartum (BP 2 ', 'BP change or (b) weight change and/or waist circumference change', 'maternal health-related quality of life, engagement and retention in LBC program, biochemical markers, vascular function testing, infant weight trajectory, incremental cost-effectiveness ratios', 'systolic BP', 'lifestyle behaviour change (LBC']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0852260', 'cui_str': 'Hypertension associated disorders of pregnancy'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C4319609', 'cui_str': '480'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0334932', 'cui_str': 'Dietitian (general)'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C1704221', 'cui_str': 'Family medicine specialist'}, {'cui': 'C0589124', 'cui_str': 'Follow-up 6 months'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C1268766', 'cui_str': 'Blood pressure alteration'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0024921', 'cui_str': 'Maternal Health'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0206015', 'cui_str': 'Biochemical Markers'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C4704805', 'cui_str': 'Weight Trajectory'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}]",480.0,0.118249,Participants are randomised to one of three groups: 1) Optimised usual care: information package and family doctor follow-up 6 months postpartum 2),"[{'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Henry', 'Affiliation': ""School of Women's and Children's Health, UNSW Medicine, University of New South Wales, Sydney, Australia; Women's and Children's Health, St George Hospital, Kogarah, New South Wales, Australia; The George Institute for Global Health, Sydney, Australia. Electronic address: Amanda.Henry@unsw.edu.au.""}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Arnott', 'Affiliation': 'The George Institute for Global Health, Sydney, Australia; Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia; Faculty of Medicine, University of New South Wales, Sydney, Australia; Sydney Medical School, University of Sydney, Australia.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Makris', 'Affiliation': 'Faculty of Medicine, University of New South Wales, Sydney, Australia; School of Medicine, Western Sydney University, Campbelltown, New South Wales, Australia.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Davis', 'Affiliation': ""School of Women's and Children's Health, UNSW Medicine, University of New South Wales, Sydney, Australia; Women's and Children's Health, St George Hospital, Kogarah, New South Wales, Australia.""}, {'ForeName': 'Annemarie', 'Initials': 'A', 'LastName': 'Hennessy', 'Affiliation': 'School of Medicine, Western Sydney University, Campbelltown, New South Wales, Australia.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Beech', 'Affiliation': 'Royal Hospital for Women, Randwick, New South Wales, Australia.'}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Pettit', 'Affiliation': 'Department of Renal Medicine, St George Hospital, Kogarah, New South Wales, Australia; St George and Sutherland Clinical School, UNSW Medicine, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Se Homer', 'Affiliation': 'Burnet Institute, Melbourne, Victoria, Australia; Faculty of Health, University of Technology, Sydney, New South Wales, Australia.'}, {'ForeName': 'Maria E', 'Initials': 'ME', 'LastName': 'Craig', 'Affiliation': ""School of Women's and Children's Health, UNSW Medicine, University of New South Wales, Sydney, Australia; Women's and Children's Health, St George Hospital, Kogarah, New South Wales, Australia.""}, {'ForeName': 'Lynne', 'Initials': 'L', 'LastName': 'Roberts', 'Affiliation': ""Women's and Children's Health, St George Hospital, Kogarah, New South Wales, Australia; St George and Sutherland Clinical School, UNSW Medicine, University of New South Wales, Sydney, Australia.""}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Hyett', 'Affiliation': 'Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia; Sydney Medical School, University of Sydney, Australia.'}, {'ForeName': 'Georgina', 'Initials': 'G', 'LastName': 'Chambers', 'Affiliation': ""National Perinatal Epidemiology and Statistics Unit, School of Women's and Children's Health and Centre for Big Data Research in Health, University of New South Wales, Sydney, NSW, Australia.""}, {'ForeName': 'Oisin', 'Initials': 'O', 'LastName': 'Fitzgerald', 'Affiliation': ""National Perinatal Epidemiology and Statistics Unit, School of Women's and Children's Health and Centre for Big Data Research in Health, University of New South Wales, Sydney, NSW, Australia.""}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Gow', 'Affiliation': 'Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Mann', 'Affiliation': 'General Practitioner, Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Challis', 'Affiliation': ""School of Women's and Children's Health, UNSW Medicine, University of New South Wales, Sydney, Australia; Royal Hospital for Women, Randwick, New South Wales, Australia.""}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Gale', 'Affiliation': 'New South Wales Ministry of Health, North Sydney, New South Wales, Australia.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Ruhotas', 'Affiliation': ""Women's and Children's Health, St George Hospital, Kogarah, New South Wales, Australia.""}, {'ForeName': 'Emilee', 'Initials': 'E', 'LastName': 'Kirwin', 'Affiliation': ""Women's and Children's Health, St George Hospital, Kogarah, New South Wales, Australia.""}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Denney-Wilson', 'Affiliation': 'Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Brown', 'Affiliation': 'Department of Renal Medicine, St George Hospital, Kogarah, New South Wales, Australia; St George and Sutherland Clinical School, UNSW Medicine, University of New South Wales, Sydney, Australia.'}]",Pregnancy hypertension,['10.1016/j.preghy.2020.07.001']
1382,32687161,"A Phase IIa Controlled Human Malaria Infection and Immunogenicity Study of RTS,S/AS01E and RTS,S/AS01B Delayed Fractional Dose Regimens in Malaria-Naive Adults.","BACKGROUND


A previous RTS,S/AS01B vaccine challenge trial demonstrated that a 3-dose (0-1-7-month) regimen with a fractional third dose can produce high vaccine efficacy (VE) in adults challenged 3 weeks after vaccination. This study explored the VE of different delayed fractional dose regimens of adult and pediatric RTS,S/AS01 formulations.
METHODS


A total of 130 participants were randomized into 5 groups. Four groups received 3 doses of RTS,S/AS01B or RTS,S/AS01E on a 0-1-7-month schedule, with the final 1 or 2 doses being fractional (one-fifth dose volume). One group received 1 full (month 0) and 1 fractional (month 7) dose of RTS,S/AS01E. Immunized and unvaccinated control participants underwent Plasmodium falciparum-infected mosquito challenge (controlled human malaria infection) 3 months after immunization, a timing chosen to potentially discriminate VEs between groups.
RESULTS


The VE of 3-dose formulations ranged from 55% (95% confidence interval, 27%-72%) to 76% (48%-89%). Groups administered equivalent formulations of RTS,S/AS01E and RTS,S/AS01B demonstrated comparable VE. The 2-dose group demonstrated lower VE (29% [95% confidence interval, 6%-46%]). All regimens were well tolerated and immunogenic, with trends toward higher anti-circumsporozoite antibody titers in participants protected against infection.
CONCLUSIONS


RTS,S/AS01E can provide VE comparable to an equivalent RTS,S/AS01B regimen in adults, suggesting a universal formulation may be considered. Results also suggest that the 2-dose regimen is inferior to the 3-dose regimens evaluated.
CLINICAL TRIAL REGISTRATION


NCT03162614.",2020,"Groups administered equivalent formulations of RTS,S/AS01E and RTS,S/AS01B demonstrated comparable VE.","['Malaria-Naïve Adults', '130 subjects']","['RTS,S/AS01E. Immunized and unvaccinated control participants underwent Plasmodium falciparum-infected mosquito challenge (CHMI) 3M post-immunization', 'RTS,S/AS01E and RTS,S/AS01B Delayed Fractional Dose Regimens', 'RTS,S/AS01B or RTS,S/AS01E']",['lower VE'],"[{'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4319552', 'cui_str': '130'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032150', 'cui_str': 'Plasmodium falciparum'}, {'cui': 'C0026584', 'cui_str': 'Family Culicidae'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0020971', 'cui_str': 'Immunization'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",130.0,0.0363794,"Groups administered equivalent formulations of RTS,S/AS01E and RTS,S/AS01B demonstrated comparable VE.","[{'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Moon', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, Maryland, USA.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Ockenhouse', 'Affiliation': 'PATH-Malaria Vaccine Initiative, Washington, DC, USA.'}, {'ForeName': 'Jason A', 'Initials': 'JA', 'LastName': 'Regules', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, Maryland, USA.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Vekemans', 'Affiliation': 'GSK Biologicals, Rixensart, Belgium.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Lee', 'Affiliation': 'PATH-Malaria Vaccine Initiative, Washington, DC, USA.'}, {'ForeName': 'Ilin', 'Initials': 'I', 'LastName': 'Chuang', 'Affiliation': 'Naval Medical Research Center, Silver Spring, Maryland, USA.'}, {'ForeName': 'Magali', 'Initials': 'M', 'LastName': 'Traskine', 'Affiliation': 'GSK Biologicals, Rixensart, Belgium.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Jongert', 'Affiliation': 'GSK Biologicals, Rixensart, Belgium.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Ivinson', 'Affiliation': 'PATH-Malaria Vaccine Initiative, Washington, DC, USA.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Morelle', 'Affiliation': 'GSK Biologicals, Rixensart, Belgium.'}, {'ForeName': 'Jack L', 'Initials': 'JL', 'LastName': 'Komisar', 'Affiliation': 'Naval Medical Research Center, Silver Spring, Maryland, USA.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Lievens', 'Affiliation': 'GSK Biologicals, Rixensart, Belgium.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Sedegah', 'Affiliation': 'Naval Medical Research Center, Silver Spring, Maryland, USA.'}, {'ForeName': 'Lindsey S', 'Initials': 'LS', 'LastName': 'Garver', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, Maryland, USA.'}, {'ForeName': 'April K', 'Initials': 'AK', 'LastName': 'Sikaffy', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, Maryland, USA.'}, {'ForeName': 'Norman C', 'Initials': 'NC', 'LastName': 'Waters', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, Maryland, USA.'}, {'ForeName': 'William Ripley', 'Initials': 'WR', 'LastName': 'Ballou', 'Affiliation': 'GSK Biologicals, Rixensart, Belgium.'}, {'ForeName': 'Opokua', 'Initials': 'O', 'LastName': 'Ofori-Anyinam', 'Affiliation': 'GSK Biologicals, Rixensart, Belgium.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of infectious diseases,['10.1093/infdis/jiaa421']
1383,33065786,"Effects of ozone autohemotherapy on blood VEGF, TGF-β and PDGF levels after finger replantation.","BACKGROUND


The study aimed to confirm the important role of ozone autologous blood therapy (autohemotherapy) in promoting successful finger replantation and its possible influence mechanism.
METHODS


A total of 150 patients with severed finger replantation admitted to our hospital from March 2018 to March 2019 were selected. Patients were divided into observation group and control group according to different treatment methods. The observation group received additional ozone autologous blood treatment in the control group. We compared the number of white blood cells, visual analogue scale (VAS) scores, and the expression levels of vascular endothelial growth factor (VEGF), transforming growth factor-β (TGF-β), and platelet-derived growth factor (PDGF) in the two groups of patients before and after intervention. We also assessed the hospitalization time and survival time of the replanted finger in the two groups, as well as blood flow values (Vbcf).
RESULTS


Compared with the observation group on the 1st day after the operation and the control group on the 7th day after the operation, the average white blood cell count of the observation group on the 7th day after the operation was significantly increased (P<0.05), and the VAS score was significantly decreased (P<0.05).48 hours after the operation, the average Vbcf value of the replanted finger was lower than that of the contralateral healthy finger (P<0.05). Compared with the control group, the Vbcf value of the replanted fingers in the observation group was higher, and the hospitalization time and finger survival time were shorter (P<0.05). At 7 days after operation, the serum VEGF, TGF-β and PDGF levels in the observation group were significantly higher than the 1 day after operation, before the operation and the control group (P<0.05).
CONCLUSIONS


Intervention with ozone autohemotherapy after severed finger replantation can significantly increase the number of white blood cells, relieve postoperative pain, and improve the survival rate of the finger body. Ozone autohemotherapy also improves the microcirculation after anastomosis of the severed finger by up-regulating the expression of VEGF, TGF-β and PDGF in blood.",2020,"At 7 days after operation, the serum VEGF, TGF-β and PDGF levels in the observation group were significantly higher than the 1 day after operation, before the operation and the control group (P<0.05).
",['150 patients with severed finger replantation admitted to our hospital from March 2018 to March 2019 were selected'],"['additional ozone autologous blood treatment', 'ozone autohemotherapy', 'ozone autologous blood therapy (autohemotherapy', 'Ozone autohemotherapy']","['hospitalization time and finger survival time', 'blood flow values (Vbcf', 'blood VEGF, TGF-β and PDGF levels', 'number of white blood cells, visual analogue scale (VAS) scores, and the expression levels of vascular endothelial growth factor (VEGF), transforming growth factor-β (TGF-β), and platelet-derived growth factor (PDGF', 'average white blood cell count', 'VAS score', 'serum VEGF, TGF-β and PDGF levels', 'number of white blood cells, relieve postoperative pain', 'hospitalization time and survival time', 'survival rate']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0264097', 'cui_str': 'Calcaneal apophysitis'}, {'cui': 'C0408894', 'cui_str': 'Reattachment of finger'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]","[{'cui': 'C0030106', 'cui_str': 'Ozone'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C2239222', 'cui_str': 'Vascular endothelial growth factor assay'}, {'cui': 'C0040691', 'cui_str': 'Transforming Growth Factor'}, {'cui': 'C0032200', 'cui_str': 'Platelet-derived growth factor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0332303', 'cui_str': 'Relieved by'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",150.0,0.0136631,"At 7 days after operation, the serum VEGF, TGF-β and PDGF levels in the observation group were significantly higher than the 1 day after operation, before the operation and the control group (P<0.05).
","[{'ForeName': 'Shaoyi', 'Initials': 'S', 'LastName': 'He', 'Affiliation': ""Department of Anesthesiology, The Third People's Hospital of Cixi City, Cixi, China.""}, {'ForeName': 'Weiting', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': ""Department of Hand Surgery, The Third People's Hospital of Cixi City, Cixi, China.""}, {'ForeName': 'Jingzhao', 'Initials': 'J', 'LastName': 'Xia', 'Affiliation': ""Department of Anesthesiology, The Third People's Hospital of Cixi City, Cixi, China.""}, {'ForeName': 'Zhongbin', 'Initials': 'Z', 'LastName': 'Lai', 'Affiliation': ""Department of Anesthesiology, The Third People's Hospital of Cixi City, Cixi, China.""}, {'ForeName': 'Di', 'Initials': 'D', 'LastName': 'Yu', 'Affiliation': ""Department of Anesthesiology, The Third People's Hospital of Cixi City, Cixi, China.""}, {'ForeName': 'Ji', 'Initials': 'J', 'LastName': 'Yao', 'Affiliation': ""Department of Anesthesiology, The Third People's Hospital of Cixi City, Cixi, China.""}, {'ForeName': 'Shuiqi', 'Initials': 'S', 'LastName': 'Cai', 'Affiliation': ""Department of Orthopedics, The Third People's Hospital of Cixi City, Cixi, China. caishuiqi123@hotmail.com.""}]",Annals of palliative medicine,['10.21037/apm-20-1467']
1384,33065791,"Effects of xipayi mouth rinse combined with minocycline on localized aggressive periodontitis' therapeutic effect and the levels of CRP, TNF-α, IL-6 in serum.","BACKGROUND


Localized aggressive periodontitis is rare periodontitis in clinical practice, which often occurs in young adults under 35 years old, seriously affecting patients' quality of life. As a tetracycline antibacterial drug, minocycline is also considered an essential choice to treat periodontal disease. However, few reports focused on the effect of xipayi mouth rinse combined with minocycline on periodontal pathogens. The goal of this study was to investigate the clinical effect of xipayi mouth rinse combined with minocycline in the treatment of localized aggressive periodontitis and its effect on the levels of CRP, TNF-α, and IL-6.
METHODS


Ninety-six patients with limited aggressive periodontitis were selected and randomly divided into two groups. Forty-eight patients in the control group were treated with xipayi mouth rinse after primary periodontal treatment. Then, 48 patients in the experimental group were treated with xipayi mouth rinse combined with minocycline after primary periodontal treatment. The periodontal probe was applied to detect periodontal plaque index (PLI), periodontal pocket depth (PD), sulcus bleeding index (SBI), gingival index (GL), and clinical attachment loss (CAL) before and after treatment in both groups of patients. ELISA was used for detecting the expression levels of CRP, TNF-α, and IL-6 in the serum of patients in two groups before and after treatment. We compared the recurrence rates of the two groups after a 1-year follow-up.
RESULTS


Compared with the control group, the PLI, PD, SBI, GL, CAL, and total masticatory efficiency of the experimental group were significantly better than those of the control group. The levels of inflammatory factors CRP, TNF-α, and IL-6 were significantly declined, and the total effective rate of treatment was significantly elevated. After follow-up, it was found there was no noticeable difference in the recurrence rate between the two groups.
CONCLUSIONS


Xipayi mouth rinse, combined with minocycline in the treatment of localized aggressive periodontitis, can significantly improve the periodontal gingival condition and reduce the level of inflammatory factors. Also, the efficacy of the treatment was significant. This experiment has provided ideas for improving the clinical treatment of patients with localized aggressive periodontitis.",2020,"The levels of inflammatory factors CRP, TNF-α, and IL-6 were significantly declined, and the total effective rate of treatment was significantly elevated.","['young adults under 35 years old', 'patients with localized aggressive periodontitis', 'Ninety-six patients with limited aggressive periodontitis', '48 patients in the experimental group']","['ELISA', 'xipayi mouth rinse combined with minocycline', 'minocycline', 'tetracycline antibacterial drug, minocycline', 'xipayi mouth rinse']","['periodontal plaque index (PLI), periodontal pocket depth (PD), sulcus bleeding index (SBI), gingival index (GL), and clinical attachment loss (CAL', 'expression levels of CRP, TNF-α, and IL-6', 'PLI, PD, SBI, GL, CAL, and total masticatory efficiency', 'recurrence rates', 'level of inflammatory factors', ""localized aggressive periodontitis' therapeutic effect and the levels of CRP, TNF-α, IL-6 in serum"", 'periodontal gingival condition', 'levels of inflammatory factors CRP, TNF-α, and IL-6', 'total effective rate of treatment', 'recurrence rate']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0392752', 'cui_str': 'Localized'}, {'cui': 'C0001342', 'cui_str': 'Acute periodontitis'}, {'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0014441', 'cui_str': 'Enzyme-linked immunosorbent assay'}, {'cui': 'C0026647', 'cui_str': 'Oromucosal solution for gargle'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0026187', 'cui_str': 'Minocycline'}, {'cui': 'C1744619', 'cui_str': 'Tetracycline antibiotic product'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0031094', 'cui_str': 'Periodontal pocket'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0392752', 'cui_str': 'Localized'}, {'cui': 'C0001342', 'cui_str': 'Acute periodontitis'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",96.0,0.0274725,"The levels of inflammatory factors CRP, TNF-α, and IL-6 were significantly declined, and the total effective rate of treatment was significantly elevated.","[{'ForeName': 'Xian', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Prosthodontics, Handan Stomatological Hospital, Handan, China. fernandes2010@163.com.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': '2Department of Pediatric Dentistry, Handan Stomatological Hospital, Handan, China.'}, {'ForeName': 'Zhifang', 'Initials': 'Z', 'LastName': 'He', 'Affiliation': '3Department of Periodontology, Handan Stomatological Hospital, Handan, China.'}, {'ForeName': 'Haijiao', 'Initials': 'H', 'LastName': 'Zhao', 'Affiliation': 'Department of Prosthodontics, Handan Stomatological Hospital, Handan, China.'}, {'ForeName': 'Yehua', 'Initials': 'Y', 'LastName': 'Cai', 'Affiliation': 'Department of Periodontology, Handan Stomatological Hospital, Handan, China.'}, {'ForeName': 'Shanglin', 'Initials': 'S', 'LastName': 'Song', 'Affiliation': 'Department of Clinical Laboratory, Handan Stomatological Hospital, Handan, China.'}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Yu', 'Affiliation': 'Department of Prosthodontics, Handan Stomatological Hospital, Handan, China. 23878024@qq.com.'}]",Annals of palliative medicine,['10.21037/apm-20-1653']
1385,33065813,Major depressive disorder with mixed features and treatment response to lurasidone: A symptom network model.,"BACKGROUND


To investigate the symptom network structure of major depressive disorder (MDD) with mixed features and implications for treatment.
METHODS


In this post-hoc analysis of a previously reported randomized trial, patients meeting DSM-IV-TR criteria for MDD presenting with two or three manic symptoms (DSM-5 mixed features specifier) were randomized to 6 weeks of double-blind treatment with lurasidone 20-60 mg/d (N = 109) or placebo (N = 100). The network structure of symptoms at baseline and their treatment moderating effects were investigated.
RESULTS


Network analyses showed that both ``elevated mood'' (YMRS item 1) and ``increased motor activity-energy'' (YMRS item 2) were associated with ``sleep disturbance'' (""bridge"" symptom) and the depressive symptom cluster. Presence of both ""elevated mood"" and ""increased motor activity-energy"" at baseline predicted significantly less improvement in MADRS and CGI-S score at week 6 with lurasidone (vs. placebo) compared to patients without these manic symptoms at baseline. The network model also showed ""rapid/pressured speech"" (YMRS item 6) at baseline predicted improvement in both manic and depressive symptoms with lurasidone vs. placebo treatment.
LIMITATIONS


This was a post-hoc analysis where findings need to be confirmed by prospective controlled studies.
CONCLUSIONS


This post-hoc analysis describes the symptom network structure of MDD with mixed features in a patient sample at study baseline. Specific manic symptoms were found to be linked to sleep disturbance (characterized as a ""bridge"" symptom), which in turn linked the manic and depressive symptom clusters. The presence (vs. absence) of the specific manic symptoms we identified moderated the antidepressant and antimanic effects of lurasidone in the treatment of MDD with mixed (subthreshold hypomanic) features.",2020,"Presence of both ""elevated mood"" and ""increased motor activity-energy"" at baseline predicted significantly less improvement in MADRS and CGI-S score at week 6 with lurasidone (vs. placebo) compared to patients without these manic symptoms at baseline.",['patients meeting DSM-IV-TR criteria for MDD presenting with two or three manic symptoms (DSM-5 mixed features specifier'],"['lurasidone', 'lurasidone 20-60\xa0mg', 'placebo', 'lurasidone (vs. placebo', 'lurasidone vs. placebo']","['motor activity-energy', 'MADRS and CGI-S score', 'sleep disturbance\'\' (""bridge"" symptom) and the depressive symptom cluster']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0338831', 'cui_str': 'Mania'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}]","[{'cui': 'C2003424', 'cui_str': 'lurasidone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0221821', 'cui_str': 'Dental bridge'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}]",2.0,0.315016,"Presence of both ""elevated mood"" and ""increased motor activity-energy"" at baseline predicted significantly less improvement in MADRS and CGI-S score at week 6 with lurasidone (vs. placebo) compared to patients without these manic symptoms at baseline.","[{'ForeName': 'Joseph F', 'Initials': 'JF', 'LastName': 'Goldberg', 'Affiliation': 'Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY. Electronic address: joseph.goldberg@mssm.edu.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Siu', 'Affiliation': 'COS and Associates Ltd., Central, Hong Kong.'}, {'ForeName': 'Yongcai', 'Initials': 'Y', 'LastName': 'Mao', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA and Fort Lee, NJ.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Tsai', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA and Fort Lee, NJ.'}, {'ForeName': 'Andrei', 'Initials': 'A', 'LastName': 'Pikalov', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA and Fort Lee, NJ.'}, {'ForeName': 'Joseph R', 'Initials': 'JR', 'LastName': 'Calabrese', 'Affiliation': 'University Hospitals Case Medical Center, Case Western Reserve University School of Medicine, Cleveland, OH.'}, {'ForeName': 'Antony', 'Initials': 'A', 'LastName': 'Loebel', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA and Fort Lee, NJ.'}]",Journal of affective disorders,['10.1016/j.jad.2020.08.048']
1386,33066805,Improving adherence to an online intervention for low mood with a virtual coach: study protocol of a pilot randomized controlled trial.,"BACKGROUND


Internet-based cognitive-behavioral therapy (iCBT) is more effective when it is guided by human support than when it is unguided. This may be attributable to higher adherence rates that result from a positive effect of the accompanying support on motivation and on engagement with the intervention. This protocol presents the design of a pilot randomized controlled trial that aims to start bridging the gap between guided and unguided interventions. It will test an intervention that includes automated support delivered by an embodied conversational agent (ECA) in the form of a virtual coach.
METHODS/DESIGN


The study will employ a pilot two-armed randomized controlled trial design. The primary outcomes of the trial will be (1) the effectiveness of iCBT, as supported by a virtual coach, in terms of improved intervention adherence in comparison with unguided iCBT, and (2) the feasibility of a future, larger-scale trial in terms of recruitment, acceptability, and sample size calculation. Secondary aims will be to assess the virtual coach's effect on motivation, users' perceptions of the virtual coach, and general feasibility of the intervention as supported by a virtual coach. We will recruit N = 70 participants from the general population who wish to learn how they can improve their mood by using Moodbuster Lite, a 4-week cognitive-behavioral therapy course. Candidates with symptoms of moderate to severe depression will be excluded from study participation. Included participants will be randomized in a 1:1 ratio to either (1) Moodbuster Lite with automated support delivered by a virtual coach or (2) Moodbuster Lite without automated support. Assessments will be taken at baseline and post-study 4 weeks later.
DISCUSSION


The study will assess the preliminary effectiveness of a virtual coach in improving adherence and will determine the feasibility of a larger-scale RCT. It could represent a significant step in bridging the gap between guided and unguided iCBT interventions.
TRIAL REGISTRATION


Netherlands Trial Register (NTR) NL8110 . Registered on 23 October 2019.",2020,"It will test an intervention that includes automated support delivered by an embodied conversational agent (ECA) in the form of a virtual coach.
","['N\u2009=\u200970 participants from the general population who wish to learn how they can improve their mood by using Moodbuster Lite, a 4-week cognitive-behavioral therapy course']","['online intervention', 'Internet-based cognitive-behavioral therapy (iCBT', 'virtual coach', 'Moodbuster Lite with automated support delivered by a virtual coach or (2) Moodbuster Lite without automated support']","['effectiveness of iCBT, as supported by a virtual coach, in terms of improved intervention adherence in comparison with unguided iCBT, and (2) the feasibility of a future, larger-scale trial in terms of recruitment, acceptability, and sample size calculation']","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0750729', 'cui_str': 'Courses'}]","[{'cui': 'C3898714', 'cui_str': 'Internet Intervention'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C1441506', 'cui_str': 'Calculation technique'}]",70.0,0.168878,"It will test an intervention that includes automated support delivered by an embodied conversational agent (ECA) in the form of a virtual coach.
","[{'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Provoost', 'Affiliation': 'Department of Clinical, Neuro- and Developmental Psychology, Clinical Psychology Section, VU University and Amsterdam Public Health Research Institute, Amsterdam, Netherlands. s.j.provoost@vu.nl.'}, {'ForeName': 'Annet', 'Initials': 'A', 'LastName': 'Kleiboer', 'Affiliation': 'Department of Clinical, Neuro- and Developmental Psychology, Clinical Psychology Section, VU University and Amsterdam Public Health Research Institute, Amsterdam, Netherlands.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Ornelas', 'Affiliation': 'Institute for Systems and Computer Engineering, Technology and Science, Porto, Portugal.'}, {'ForeName': 'Tibor', 'Initials': 'T', 'LastName': 'Bosse', 'Affiliation': 'Behavioural Science Institute, Radboud University, Nijmegen, Netherlands.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Ruwaard', 'Affiliation': 'Department of Psychiatry, Amsterdam UMC, Location VU University Medical Centre, and Amsterdam Public Health Research Institute, Amsterdam, Netherlands.'}, {'ForeName': 'Artur', 'Initials': 'A', 'LastName': 'Rocha', 'Affiliation': 'Institute for Systems and Computer Engineering, Technology and Science, Porto, Portugal.'}, {'ForeName': 'Pim', 'Initials': 'P', 'LastName': 'Cuijpers', 'Affiliation': 'Department of Clinical, Neuro- and Developmental Psychology, Clinical Psychology Section, VU University and Amsterdam Public Health Research Institute, Amsterdam, Netherlands.'}, {'ForeName': 'Heleen', 'Initials': 'H', 'LastName': 'Riper', 'Affiliation': 'Department of Clinical, Neuro- and Developmental Psychology, Clinical Psychology Section, VU University and Amsterdam Public Health Research Institute, Amsterdam, Netherlands.'}]",Trials,['10.1186/s13063-020-04777-2']
1387,33066811,"Therapeutic benefits of music-based synchronous finger tapping in Parkinson's disease-an fNIRS study protocol for randomized controlled trial in Dalian, China.","BACKGROUND


Music therapy improves neuronal activity and connectivity of healthy persons and patients with clinical symptoms of neurological diseases like Parkinson's disease, Alzheimer's disease, and major depression. Despite the plethora of publications that have reported the positive effects of music interventions, little is known about how music improves neuronal activity and connectivity in afflicted patients.
METHODS


For patients suffering from Parkinson's disease (PD), we propose a daily 25-min music-based synchronous finger tapping (SFT) intervention for 8 weeks. Eligible participants with PD are split into two groups: an intervention group and a control arm. In addition, a third cohort of healthy controls will be recruited. Assessment of finger tapping performances, the Unified Parkinson's Disease Rating Scale (UPDRS), an n-back test, the Montreal Cognitive Assessment (MoCA), as well as oxygenated hemoglobin (HbO 2 ), deoxygenated hemoglobin (HbR), and total hemoglobin activation collected by functional near-infrared spectroscopy (fNIRS) are measured at baseline, week 4 (during), week 8 (post), and week 12 (retention) of the study. Data collected from the two PD groups are compared to baseline performances from healthy controls.
DISCUSSION


This exploratory prospective trial study investigates the cortical neuronal activity and therapeutic effects associated with an auditory external cue used to induce automatic and implicit synchronous finger tapping in patients diagnosed with PD. The extent to which the intervention is effective may be dependent on the severity of the disease. The study's findings are used to inform larger clinical studies for optimization and further exploration of the therapeutic effects of movement-based music therapy on neural activity in neurological diseases.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04212897 . Registered on December 30, 2019. The participant recruitment and study protocol have received ethical approval from the First Affiliated Hospital of Dalian Medical University. The hospital Protocol Record number is PJ-KY-2019-123. The protocol was named ""fNIRS Studies of Music Intervention of Parkinson's Disease."" The current protocol is version 1.1, revised on September 1, 2020.",2020,"Assessment of finger tapping performances, the Unified Parkinson's Disease Rating Scale (UPDRS), an n-back test, the Montreal Cognitive Assessment (MoCA), as well as oxygenated hemoglobin (HbO 2 ), deoxygenated hemoglobin (HbR), and total hemoglobin activation collected by functional near-infrared spectroscopy (fNIRS) are measured at baseline, week 4 (during), week 8 (post), and week 12 (retention) of the study.","['Eligible participants with PD', ""healthy persons and patients with clinical symptoms of neurological diseases like Parkinson's disease, Alzheimer's disease, and major depression"", ""patients suffering from Parkinson's disease (PD"", ""Parkinson's disease-an fNIRS study protocol for randomized controlled trial in Dalian, China"", 'patients diagnosed with PD']","['auditory external cue used to induce automatic and implicit synchronous finger tapping', 'music-based synchronous finger tapping', 'Music therapy', 'daily 25-min music-based synchronous finger tapping (SFT) intervention']","['neuronal activity and connectivity', ""Assessment of finger tapping performances, the Unified Parkinson's Disease Rating Scale (UPDRS), an n-back test, the Montreal Cognitive Assessment (MoCA), as well as oxygenated hemoglobin (HbO 2 ), deoxygenated hemoglobin (HbR), and total hemoglobin activation collected by functional near-infrared spectroscopy (fNIRS""]","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0027765', 'cui_str': 'Disorder of nervous system'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0376519', 'cui_str': 'Near-infrared spectroscopy'}, {'cui': 'C2599718', 'cui_str': 'Clinical Trial Protocols'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0439580', 'cui_str': 'Synchronous'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0026868', 'cui_str': 'Music therapy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0907533', 'cui_str': 'NOS1 protein, human'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0030069', 'cui_str': 'Oxyhemoglobin'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0475206', 'cui_str': '% total hemoglobin'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0376519', 'cui_str': 'Near-infrared spectroscopy'}]",,0.0567397,"Assessment of finger tapping performances, the Unified Parkinson's Disease Rating Scale (UPDRS), an n-back test, the Montreal Cognitive Assessment (MoCA), as well as oxygenated hemoglobin (HbO 2 ), deoxygenated hemoglobin (HbR), and total hemoglobin activation collected by functional near-infrared spectroscopy (fNIRS) are measured at baseline, week 4 (during), week 8 (post), and week 12 (retention) of the study.","[{'ForeName': 'Lanlan', 'Initials': 'L', 'LastName': 'Pu', 'Affiliation': 'Department of Neurology, the First Affiliated Hospital of Dalian Medical University, Dalian, Liaoning Province, China.'}, {'ForeName': 'Nauman Khalid', 'Initials': 'NK', 'LastName': 'Qureshi', 'Affiliation': 'School of Biomedical Engineering, Faculty of Electronic Information and Electrical Engineering, Dalian University of Technology, Dalian, Liaoning Province, China.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Ly', 'Affiliation': 'Department of Biomedical Engineering, University of California, Irvine, CA, USA.'}, {'ForeName': 'Bingwei', 'Initials': 'B', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurology, the First Affiliated Hospital of Dalian Medical University, Dalian, Liaoning Province, China.'}, {'ForeName': 'Fengyu', 'Initials': 'F', 'LastName': 'Cong', 'Affiliation': 'School of Biomedical Engineering, Faculty of Electronic Information and Electrical Engineering, Dalian University of Technology, Dalian, Liaoning Province, China.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Tang', 'Affiliation': 'Department of Biomedical Engineering, University of California, Irvine, CA, USA. wctang@uci.edu.'}, {'ForeName': 'Zhanhua', 'Initials': 'Z', 'LastName': 'Liang', 'Affiliation': 'Department of Neurology, the First Affiliated Hospital of Dalian Medical University, Dalian, Liaoning Province, China. zhanhualiang@163.com.'}]",Trials,['10.1186/s13063-020-04770-9']
1388,33066812,A blended eHealth intervention for insomnia following acquired brain injury: study protocol for a randomized controlled trial.,"BACKGROUND


Up to a third of stroke patients and patients with traumatic brain injury suffer from insomnia, including problems to fall asleep or stay asleep at night. Insomnia may exacerbate other brain damage-related problems, for example regarding cognitive functioning and emotional well-being; may lead to poorer quality of life; and may complicate recovery processes. Cognitive behavioral therapy for insomnia, delivered face-to-face or online, is found to be effective in the general population. However, despite the high prevalence and serious consequences of insomnia following acquired brain injury, studies on the efficacy of face-to-face cognitive behavioral treatment in this population are scarce, and this applies even more for studies on online cognitive behavioral therapy. Therefore, this study aims to evaluate the efficacy of a newly developed guided online cognitive behavioral therapy for insomnia following acquired brain injury.
METHODS


A multicenter, prospective, randomized, open-label, blinded end point study (PROBE) will be conducted, in which 48 patients diagnosed with stroke or traumatic brain injury and insomnia will be randomly allocated to the online cognitive behavioral therapy for insomnia treatment group or the treatment as usual group. The treatment consists of 6 online cognitive behavioral therapy sessions given on a weekly basis and personalized feedback after each session, combined with 2 face-to-face sessions. Outcomes will be assessed at baseline, immediately after the intervention period and at 6-week follow-up. The primary outcome is the insomnia severity assessed with the Insomnia Severity Index. Secondary outcome measures include sleep quality, sleep features derived from the sleep diary, fatigue, anxiety and depression, subjective cognitive functioning, and societal participation.
DISCUSSION


This study will provide insight on the efficacy of online cognitive behavioral therapy for insomnia following stroke and traumatic brain injury.
TRIAL REGISTRATION


Netherlands Trial Register NTR7082 . Registered on 12 March 2018.",2020,"Cognitive behavioral therapy for insomnia, delivered face-to-face or online, is found to be effective in the general population.","['stroke patients and patients with traumatic brain injury suffer from insomnia, including problems to fall asleep or stay asleep at night', '48 patients diagnosed with stroke or traumatic brain injury and insomnia']","['guided online cognitive behavioral therapy', 'blended eHealth intervention', 'online cognitive behavioral therapy for insomnia treatment group or the treatment as usual group', 'Cognitive behavioral therapy', 'online cognitive behavioral therapy']","['insomnia severity assessed with the Insomnia Severity Index', 'sleep quality, sleep features derived from the sleep diary, fatigue, anxiety and depression, subjective cognitive functioning, and societal participation']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0424522', 'cui_str': 'Asleep'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}]",48.0,0.0795238,"Cognitive behavioral therapy for insomnia, delivered face-to-face or online, is found to be effective in the general population.","[{'ForeName': 'Marthe E', 'Initials': 'ME', 'LastName': 'Ford', 'Affiliation': 'Department of Psychology, Heliomare Rehabilitation, Wijk aan Zee, The Netherlands. m.e.ford@vu.nl.'}, {'ForeName': 'Gert J', 'Initials': 'GJ', 'LastName': 'Geurtsen', 'Affiliation': 'Department of Medical Psychology, Amsterdam UMC, location AMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Erny', 'Initials': 'E', 'LastName': 'Groet', 'Affiliation': 'Department of Psychology, Heliomare Rehabilitation, Wijk aan Zee, The Netherlands.'}, {'ForeName': 'Coen A M', 'Initials': 'CAM', 'LastName': 'Van Bennekom', 'Affiliation': 'Department of Medical Psychology, Amsterdam UMC, location AMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Eus J W', 'Initials': 'EJW', 'LastName': 'Van Someren', 'Affiliation': 'Department of Sleep and Cognition, Netherlands Institute for Neuroscience, Amsterdam, The Netherlands.'}]",Trials,['10.1186/s13063-020-04789-y']
1389,33066856,Effect of Turmacin supplementation on joint discomfort and functional outcome among healthy participants - A randomized placebo-controlled trial.,"OBJECTIVE


Curcuma longa has been widely used in Ayurveda for its medicinal properties and Turmacin was developed from C. longa as a standardized extract containing turmerosaccharides. In this clinical trial, the effect of Turmacin on knee joint discomfort in healthy adults subjected to strenuous physical activity was evaluated.
DESIGN


Double-blind, triple-arm, parallel-group, randomized placebo-controlled trial.
SETTING


Healthy participants from an urban tertiary care teaching hospital.
INTERVENTION


Healthy participants were randomized in 1:1:1 ratio to receive either Turmacin 0.5 g/1 g or placebo once daily for 84 days. The participants were subjected to 10-minute strenuous exercise.
OUTCOME MEASURES


Time to initial pain, final pain score on a visual analogue scale, range of movement (ROM) of knee and the force of contractions of muscles around the knee joint.
RESULTS


A total of n = 90 participants were recruited. The mean final pain scores were significantly lower in the Turmacin 1 g and Turmacin 0.5 g when compared with the placebo from day-7 and day-5 onwards respectively. The survival analysis consistently showed a decreased hazard for early onset of pain in both the Turmacin groups. On day-84, the difference in mean ROM between Turmacin 0.5 g and placebo was 4.79 degrees (p = 0.008) and that for Turmacin 1 g and placebo was 2.34 degrees (p = 0.306). The difference in muscle force for isokinetic contractions of the quadriceps at angular velocities of 120 and 180 was significant between Turmacin 0.5 g and placebo (p = 0.002 and p = 0.005 respectively) while that for Turmacin 1 g & Turmacin 0.5 g (p = 0.206 and p = 0.414 respectively) and Turmacin 1 g & Placebo (p = 0.046 and p = 0.037) were not significant. However, in the within group analysis participants in Turmacin 1 g group had better preserved muscle functions than Turmacin 0.5 g group at angular velocities of 120 and 180 when compared with placebo.
CONCLUSION


Turmacin (0.5 g and 1 g) was efficacious when compared to placebo in increasing the pain threshold and knee ROM in healthy participants with minor adverse events.",2020,The mean final pain scores were significantly lower in the Turmacin 1 g and Turmacin 0.5 g when compared with the placebo from day-7 and day-5 onwards respectively.,"['healthy adults', 'healthy participants with minor adverse events', 'A total of n\u2009=\u200990 participants were recruited', 'Healthy participants from an urban tertiary care teaching hospital', 'healthy participants - A randomized', 'Healthy participants']","['10-minute strenuous exercise', 'Turmacin supplementation', 'Turmacin', 'placebo', 'Placebo', 'Turmacin 0.5\u2009g/1\u2009g or placebo']","['muscle functions', 'muscle force for isokinetic contractions of the quadriceps at angular velocities', 'Time to initial pain, final pain score on a visual analogue scale, range of movement (ROM) of knee and the force of contractions of muscles around the knee joint', 'joint discomfort and functional outcome', 'mean final pain scores', 'pain threshold and knee ROM', 'mean ROM', 'knee joint discomfort']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0444500', 'cui_str': '0.5'}]","[{'cui': 'C0231484', 'cui_str': 'Muscle function'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0022745', 'cui_str': 'Knee joint structure'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}]",90.0,0.572943,The mean final pain scores were significantly lower in the Turmacin 1 g and Turmacin 0.5 g when compared with the placebo from day-7 and day-5 onwards respectively.,"[{'ForeName': 'Jeffrey Pradeep', 'Initials': 'JP', 'LastName': 'Raj', 'Affiliation': ""Department of Clinical Pharmacology, St. John's Medical College, Bangalore 560 034, India. Electronic address: jpraj.m07@gmail.com.""}, {'ForeName': 'Shreeraam', 'Initials': 'S', 'LastName': 'Venkatachalam', 'Affiliation': ""Department of Orthopaedics, St. John's Medical College, Bangalore 560 034, India.""}, {'ForeName': 'Pranathi', 'Initials': 'P', 'LastName': 'Racha', 'Affiliation': ""Department of Physiology, St. John's Medical College, Bangalore 560 034, India.""}, {'ForeName': 'Sreejith', 'Initials': 'S', 'LastName': 'Bhaskaran', 'Affiliation': ""Division of Nutrition, St. John's Research Institute, Bangalore 560 034, India.""}, {'ForeName': 'Rajkumar S', 'Initials': 'RS', 'LastName': 'Amaravati', 'Affiliation': ""Department of Orthopaedics, St. John's Medical College, Bangalore 560 034, India.""}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102522']
1390,33067493,Resistance exercise training for anxiety and worry symptoms among young adults: a randomized controlled trial.,"This trial quantified the effects of ecologically-valid resistance exercise training (RET) on anxiety and worry symptoms among young adults. Young adults not meeting criteria for subclinical, or analogue Generalized Anxiety Disorder (AGAD) were randomized to an eight-week RET intervention, or eight-week wait-list. AGAD status was determined using validated cut-scores for both the Psychiatric Diagnostic Screening Questionnaire-Generalized Anxiety Disorder subscale (≥ 6) and Penn State Worry Questionnaire (≥ 45). The primary outcome was anxiety symptoms measured with the Trait Anxiety subscale of the State-Trait Anxiety Inventory. The RET was designed according to World Health Organization and American College of Sports Medicine guidelines. RM-ANCOVA examined differences between RET and wait-list over time. Significant interactions were decomposed with simple effects analysis. Hedges' d effect sizes quantified magnitude of differences in change between RET and wait-list. Twenty-eight participants (64% female) fully engaged in the trial (mean age: 26.0 ± 6.2y, RET: n = 14; Wait-list: n = 14). A significant group X time interaction was found for anxiety symptoms (F (3,66)  = 3.60, p ≤ 0.019; d = 0.85, 95%CI: 0.06 to 1.63). RET significantly reduced anxiety symptoms from baseline to post-intervention (mean difference =  - 7.89, p ≤ 0.001). No significant interaction was found for worry (F (3,69)  = 0.79, p ≥ 0.50; d =  - 0.22, 95%CI: - 0.96 to 0.53). Ecologically-valid RET significantly improves anxiety symptoms among young adults.Trial Registration: Clinicaltrials.gov Identifier: NCT04116944, 07/10/2019.",2020,"RET significantly reduced anxiety symptoms from baseline to post-intervention (mean difference =  - 7.89, p ≤ 0.001).","['Twenty-eight participants (64% female) fully engaged in the trial (mean age: 26.0\u2009±\u20096.2y, RET: n\u2009=\u200914; Wait-list: n\u2009=\u200914', 'young adults', 'Young adults not meeting criteria for subclinical, or analogue Generalized Anxiety Disorder (AGAD']","['Resistance exercise training', 'RET', 'ecologically-valid resistance exercise training (RET']","['anxiety symptoms measured with the Trait Anxiety subscale of the State-Trait Anxiety Inventory', 'Psychiatric Diagnostic Screening Questionnaire-Generalized Anxiety Disorder subscale (≥\u20096) and Penn State Worry Questionnaire', 'anxiety and worry symptoms', 'anxiety symptoms']","[{'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205211', 'cui_str': 'Subclinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}]","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C2959752', 'cui_str': 'Penn State worry questionnaire'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",28.0,0.108717,"RET significantly reduced anxiety symptoms from baseline to post-intervention (mean difference =  - 7.89, p ≤ 0.001).","[{'ForeName': 'Brett R', 'Initials': 'BR', 'LastName': 'Gordon', 'Affiliation': 'Department of Physical Education and Sport Sciences, University of Limerick, Limerick, Ireland. brg5334@psu.edu.'}, {'ForeName': 'Cillian P', 'Initials': 'CP', 'LastName': 'McDowell', 'Affiliation': 'Department of Physical Education and Sport Sciences, University of Limerick, Limerick, Ireland.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Lyons', 'Affiliation': 'Department of Physical Education and Sport Sciences, University of Limerick, Limerick, Ireland.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Herring', 'Affiliation': 'Department of Physical Education and Sport Sciences, University of Limerick, Limerick, Ireland.'}]",Scientific reports,['10.1038/s41598-020-74608-6']
1391,33068348,[Different needling depth for benign prostatic hyperplasia: a randomized controlled trial].,"OBJECTIVE


To observe the therapeutic effect of different needling depth for benign prostatic hyperplasia.
METHODS


A total of 70 patients with benign prostatic hyperplasia were randomized into an elongated needle group (35 cases, 1 case dropped off) and a filiform needle group (35 cases, 2 cases dropped off). Basic treatment combined with acupuncture were adopted in both groups, acupuncture was applied at Guanyuan (CV 4), Zhongji (CV 3), Shuidao (ST 28), Sanyinjiao (SP 6), Taixi (KI 3), Zhigou (TE 6). In the elongated needle group, acupuncture was performed at Guanyuan (CV 4), Zhongji (CV 3), Shuidao (ST 28) by elongated needle, the needling depth was 60-73 mm. In the filiform needle group, acupuncture was performed at Guanyuan (CV 4), Zhongji (CV 3), Shuidao (ST 28) by filiform needle, the needling depth was 25-30 mm. The treatment was given once a day (except Sunday), 2 weeks as one course, 1 course was required in both groups. Before and after treatment, the international prostate symptom score(IPSS), quality of life (QOL) score and prostate volume were observed in the two groups, and the therapeutic effect was evaluated.
RESULTS


Compared before treatment, the IPSS and QOL scores after 1, 2-week treatment were reduced ( P <0.01), and the IPSS and QOL scores after 2-week treatment were lower than those after 1-week treatment in the two groups ( P <0.01); the IPSS and QOL scores after 2-week treatment in the elongated needle group were lower than the filiform needle group ( P <0.05,  P <0.01). After 2-week treatment, the prostate volume was reduced in the two groups ( P <0.01,  P <0.05). The total effective rate was 91.2% (31/34) in the elongated needle group, which was superior to 72.7% (24/33) in the filiform needle group ( P <0.05).
CONCLUSION


Both elongated needle and filiform needle can improve the symptom and quality of life in patients with benign prostatic hyperplasia, and elongated needle has the better therapeutic effect.",2020,"After 2-week treatment, the prostate volume was reduced in the two groups ( P <0.01,  P <0.05).","['benign prostatic hyperplasia', 'patients with benign prostatic hyperplasia', '70 patients with benign prostatic hyperplasia']","['filiform needle group', 'acupuncture', 'elongated needle and filiform needle']","['international prostate symptom score(IPSS), quality of life (QOL) score and prostate volume', 'total effective rate', 'prostate volume', 'symptom and quality of life', 'IPSS and QOL scores']","[{'cui': 'C0005001', 'cui_str': 'Hypertrophy, Benign Prostatic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0332226', 'cui_str': 'Filiform'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0205166', 'cui_str': 'Long'}]","[{'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1998280', 'cui_str': 'International prostate symptom score'}]",70.0,0.0162849,"After 2-week treatment, the prostate volume was reduced in the two groups ( P <0.01,  P <0.05).","[{'ForeName': 'Mu-Fu', 'Initials': 'MF', 'LastName': 'Li', 'Affiliation': 'First Teaching Hospital of Tianjin University of TCM, National Clinical Medical Research Center of Acupuncture-Moxibustion in TCM, Tianjin 300193, China.'}, {'ForeName': 'Jin-Miao', 'Initials': 'JM', 'LastName': 'Lv', 'Affiliation': 'First Teaching Hospital of Tianjin University of TCM, National Clinical Medical Research Center of Acupuncture-Moxibustion in TCM, Tianjin 300193, China.'}, {'ForeName': 'Ling-Fei', 'Initials': 'LF', 'LastName': 'Zhao', 'Affiliation': 'First Teaching Hospital of Tianjin University of TCM, National Clinical Medical Research Center of Acupuncture-Moxibustion in TCM, Tianjin 300193, China.'}, {'ForeName': 'Hong-Yue', 'Initials': 'HY', 'LastName': 'Niu', 'Affiliation': 'First Teaching Hospital of Tianjin University of TCM, National Clinical Medical Research Center of Acupuncture-Moxibustion in TCM, Tianjin 300193, China.'}]",Zhongguo zhen jiu = Chinese acupuncture & moxibustion,['10.13703/j.0255-2930.20190923-0001']
1392,33068349,[Acupuncture at Sifeng (EX-UE 10) as adjuvant treatment for pneumonia of phlegm-heat blocking lung type in children: a randomized controlled trial].,"OBJECTIVE


To observe the clinical therapeutic effect of acupuncture at Sifeng (EX-UE 10) as adjuvant treatment for pneumonia of phlegm-heat blocking lung type in children.
METHODS


A total of 80 children with pneumonia of phlegm-heat blocking lung type were randomized into an observation group (40 cases, 1 case dropped off) and a control group (40 cases). In the control group, routine anti-infection and symptomatic and supportive treatment were given. On the basis of the treatment in the control group, acupuncture was applied at Sifeng (EX-UE 10) in the observation group, once every 2 days, 4 times were required. Before and after treatment, the score of clinical symptoms and signs and level of serum hypersensitive C-reactive protein (hs-CRP) were observed in the two groups. The antifebrile time, lung moist rale disappearance time, duration of antibacterial drugs and hospital stays were recorded, and the clinical therapeutic effect was evaluated in the two groups.
RESULTS


After treatment, the scores of clinical symptoms and signs and levels of serum hs-CRP were reduced in the two groups ( P <0.01), and the changes of scores of fever, cough and lung moist rale, secondary symptom score, total score of clinical symptoms and signs and level of serum hs-CRP in the observation group were larger than those in the control group ( P <0.05,  P <0.01). The antifebrile time, lung moist rale disappearance time, duration of antibacterial drugs and hospital stays in the observation group were shorter than those in the control group ( P <0.05). The total effective rate was 87.2% (34/39) in the observation group, which was superior to 65.0% (26/40) in the control group ( P <0.05).
CONCLUSION


Acupuncture at Sifeng (EX-UE 10) as adjuvant treatment can relieve clinical symptoms, shorten duration of antibacterial drugs and hospital stays for children with pneumonia of phlegm-heat blocking lung type.",2020,"After treatment, the scores of clinical symptoms and signs and levels of serum hs-CRP were reduced in the two groups ( P <0.01), and the changes of scores of fever, cough and lung moist rale, secondary symptom score, total score of clinical symptoms and signs and level of serum hs-CRP in the observation group were larger than those in the control group ( P <0.05,  P <0.01).","['pneumonia of phlegm-heat blocking lung type in children', '80 children with pneumonia of phlegm-heat blocking lung type', 'children with pneumonia of phlegm-heat blocking lung type']","['acupuncture at Sifeng (EX-UE 10', 'acupuncture', 'Acupuncture at Sifeng (EX-UE 10']","['changes of scores of fever, cough and lung moist rale, secondary symptom score, total score of clinical symptoms and signs and level of serum hs-CRP', 'total effective rate', 'clinical therapeutic effect', 'score of clinical symptoms and signs and level of serum hypersensitive C-reactive protein (hs-CRP', 'scores of clinical symptoms and signs and levels of serum hs-CRP', 'antifebrile time, lung moist rale disappearance time, duration of antibacterial drugs and hospital stays']","[{'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0225378', 'cui_str': 'Upper respiratory tract mucus'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}]","[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0858640', 'cui_str': 'Moist rales'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0279516', 'cui_str': 'Antibacterial'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",80.0,0.018728,"After treatment, the scores of clinical symptoms and signs and levels of serum hs-CRP were reduced in the two groups ( P <0.01), and the changes of scores of fever, cough and lung moist rale, secondary symptom score, total score of clinical symptoms and signs and level of serum hs-CRP in the observation group were larger than those in the control group ( P <0.05,  P <0.01).","[{'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Qiao', 'Affiliation': 'Second Clinical Medical College, Nanjing University of Chinese Medicine, Nanjing 210023, Jiangsu Province, China; Department of Acupuncture and Moxibustion, Affiliated Jiangning Hospital of Nanjing Medical University, Nanjing 211101, Jiangsu Province.'}, {'ForeName': 'Lan-Ying', 'Initials': 'LY', 'LastName': 'Liu', 'Affiliation': 'Department of Acupuncture and Moxibustion, Affiliated Hospital of Nanjing University of Chinese Medicine.'}, {'ForeName': 'Dan-Yan', 'Initials': 'DY', 'LastName': 'Xu', 'Affiliation': 'Department of Acupuncture and Moxibustion, Affiliated Jiangning Hospital of Nanjing Medical University, Nanjing 211101, Jiangsu Province.'}, {'ForeName': 'Zhi-Qin', 'Initials': 'ZQ', 'LastName': 'Luo', 'Affiliation': 'Department of Acupuncture and Moxibustion, Affiliated Jiangning Hospital of Nanjing Medical University, Nanjing 211101, Jiangsu Province.'}, {'ForeName': 'Yi-Huang', 'Initials': 'YH', 'LastName': 'Gu', 'Affiliation': 'Second Clinical Medical College, Nanjing University of Chinese Medicine, Nanjing 210023, Jiangsu Province, China.'}]",Zhongguo zhen jiu = Chinese acupuncture & moxibustion,['10.13703/j.0255-2930.20200302-k0001']
1393,33068350,[Therapeutic effect of acupoint injection as adjuvant treatment on dry eyes of convalescent herpes simplex keratitis].,"OBJECTIVE


To evaluate the clinical effect of acupoint injection of  houttuynia cordata  as the accessory treatment on dry eyes of convalescent herpes simplex keratitis (HSK).
METHODS


A total of 60 patients with dry eyes of convalescent HSK were randomized into an observation group and a control group, 30 cases in each one. In the control group, the artificial tears and anti-inflammatory drugs were combined in treatment. In the observation group, on the base of the treatment as the control group, the acupoint injection of  houttuynia cordata  at Neiqiuhou (Extra) was combined, 3 mL each time, once a day. After consecutive 3 injections, the injection was adjusted to be once every two days, consecutively for 3 times. The treatment for 6 times was as one course and one course of treatment was required. Separately, before treatment and in 7, 15 and 30 days after treatment, the changes of the scores of visual analogue scale (VAS), theresults of SchirmerⅠtest (SⅠT), the tear break-up time (BUT) and the score of corneal fluorescein staining (CFS) were observed and analyzed in the patients of the two groups.
RESULTS


In 7, 15 and 30 days after treatment, VAS scores and CFS scores were all reduced as compared with those before treatment in the patients of the two groups ( P <0.05), and the scores of VAS and CFS in the observation group were lower than those in the control group ( P <0.05). In 7, 15 and 30 days after treatment, the values of SⅠT and BUT were all increased as compared with those before treatment in the patients of the two groups ( P <0.05), and the values in the observation group were higher than the control group in 15 and 30 days after treatment ( P <0.05).
CONCLUSION


Acupoint injection of  houttuynia cordata  promotes corneal epithelial recovery, reduces the discomfort symptoms as well as increases tear secretion and the stability of tear film in dry eyes of convalescent herpes simplex keratitis.",2020,"In 7, 15 and 30 days after treatment, VAS scores and CFS scores were all reduced as compared with those before treatment in the patients of the two groups ( P <0.05), and the scores of VAS and CFS in the observation group were lower than those in the control group ( P <0.05).","['dry eyes of convalescent herpes simplex keratitis', '60 patients with dry eyes of convalescent HSK', 'dry eyes of convalescent herpes simplex keratitis (HSK']","['acupoint injection of  houttuynia cordata  at Neiqiuhou (Extra', 'acupoint injection', 'acupoint injection of  houttuynia cordata']","['scores of VAS and CFS', 'scores of visual analogue scale (VAS), theresults of SchirmerⅠtest (SⅠT), the tear break-up time (BUT) and the score of corneal fluorescein staining (CFS', 'VAS scores and CFS scores', 'values of SⅠT and BUT', 'corneal epithelial recovery']","[{'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}, {'cui': 'C0740326', 'cui_str': 'Convalescent'}, {'cui': 'C0228492', 'cui_str': 'Structure of posterior semilunar lobule'}, {'cui': 'C0022568', 'cui_str': 'Keratitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0001302', 'cui_str': 'Acupuncture point'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C1001040', 'cui_str': 'Dokudami'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0015674', 'cui_str': 'Chronic fatigue syndrome'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0060520', 'cui_str': 'Fluorescein'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",60.0,0.0300676,"In 7, 15 and 30 days after treatment, VAS scores and CFS scores were all reduced as compared with those before treatment in the patients of the two groups ( P <0.05), and the scores of VAS and CFS in the observation group were lower than those in the control group ( P <0.05).","[{'ForeName': 'Guang-Hong', 'Initials': 'GH', 'LastName': 'Zhang', 'Affiliation': 'Department of Ophthalmology, Hubei Provincial Hospital of TCM, Wuhan 430061, China; Department of Ophthalmology, Hubei Province Academy of TCM, Wuhan 430074, China.'}, {'ForeName': 'Xiao-Yu', 'Initials': 'XY', 'LastName': 'Li', 'Affiliation': 'Department of Ophthalmology, Hubei Provincial Hospital of TCM, Wuhan 430061, China; Department of Ophthalmology, Hubei Province Academy of TCM, Wuhan 430074, China.'}, {'ForeName': 'Du-Jun', 'Initials': 'DJ', 'LastName': 'Li', 'Affiliation': 'Department of Ophthalmology, Hubei Provincial Hospital of TCM, Wuhan 430061, China; Department of Ophthalmology, Hubei Province Academy of TCM, Wuhan 430074, China.'}, {'ForeName': 'Ke-Hu', 'Initials': 'KH', 'LastName': 'Wu', 'Affiliation': 'Department of Ophthalmology, Hubei Provincial Hospital of TCM, Wuhan 430061, China; Department of Ophthalmology, Hubei Province Academy of TCM, Wuhan 430074, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Wu', 'Affiliation': 'Department of Ophthalmology, Central China Normal University Hospital.'}, {'ForeName': 'Ji-Hong', 'Initials': 'JH', 'LastName': 'Luo', 'Affiliation': 'Department of Ophthalmology, Hubei Provincial Hospital of TCM, Wuhan 430061, China; Department of Ophthalmology, Hubei Province Academy of TCM, Wuhan 430074, China.'}]",Zhongguo zhen jiu = Chinese acupuncture & moxibustion,['10.13703/j.0255-2930.20191230-k0008']
1394,33074110,Breathing exercises and pranayamas to decrease perceived exertion during breath-holding while locked-down due to COVID-19 online randomized study.,"AIM


to compare anulom vilom pranayama (AVP), kapal bhati pranayama (KBP), diaphragmatic breathing exercises (DBE), and pursed-lip breathing (PLB) for breath holding time (BHT) and rating of perceived exertion (RPE). Methods- Participants were assessed for BHT and RPE, before training on any one intervention using online platforms, for one week during lockdown from COVID-19.15 participants in each group total N = 60 at- (α - 0.05), (1- β - 0.90) & (effect size - 0.55); were analysed. Results - AVP & DBE decreased RPE (p < 0.000). KBP & PLB did not decrease RPE as compared to AVP & DBE (p. > 0.05). DBE increased BHT more than KBP & PLB interventions (p < 0.05), but not more than AVP (p > 0.05). One-way ANOVA of four interventions revealed significant variation for RPE change (p < 0.05), for AVP. Conclusions - AVP reduces RPE maximally during breath-holding, whereas DPE increases BHT more.",2020,KBP & PLB did not decrease RPE as compared to AVP & DBE,['60\xa0at'],"['Breathing exercises and pranayamas to decrease perceived exertion during breath-holding while locked', 'AVP & DBE']","['RPE', 'anulom vilom pranayama (AVP), kapal bhati pranayama (KBP), diaphragmatic breathing exercises (DBE), and pursed-lip breathing (PLB) for breath holding time (BHT) and rating of perceived exertion (RPE', 'RPE change', 'DBE increased BHT']",[],"[{'cui': 'C0006155', 'cui_str': 'Physiotherapeutic breathing exercise'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0235744', 'cui_str': 'Interrupted breathing'}, {'cui': 'C0454509', 'cui_str': 'Diaphragmatic breathing exercises'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0454509', 'cui_str': 'Diaphragmatic breathing exercises'}, {'cui': 'C0425465', 'cui_str': 'Pursed-lip breathing'}, {'cui': 'C0235744', 'cui_str': 'Interrupted breathing'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",,0.0686435,KBP & PLB did not decrease RPE as compared to AVP & DBE,"[{'ForeName': 'Mayank', 'Initials': 'M', 'LastName': 'Shukla', 'Affiliation': 'AP-III, AIPT, 9711113097, India. Electronic address: mailmayankshukla@gmail.com.'}, {'ForeName': 'Diksha', 'Initials': 'D', 'LastName': 'Chauhan', 'Affiliation': 'BPT Interns, AIPT, India.'}, {'ForeName': 'Ritu', 'Initials': 'R', 'LastName': 'Raj', 'Affiliation': 'BPT Interns, AIPT, India.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101248']
1395,33074143,Ketamine Alters Electrophysiological Responses to Emotional Faces in Major Depressive Disorder.,"BACKGROUND


The glutamatergic modulator ketamine rapidly reduces depressive symptoms in individuals with treatment-resistant major depressive disorder (MDD). However, ketamine's effects on emotional processing biases remain largely unknown, and understanding these processes may help elucidate ketamine's mechanism of action.
METHODS


Magnetoencephalography (MEG) was used to investigate ketamine's effects on early visual responses to affective stimuli in individuals with MDD (n=31) and healthy volunteers (HVs; n=24). Participants were enrolled in a double-blind, placebo-controlled, crossover clinical trial and were assessed at baseline and after subanesthetic-dose ketamine and placebo-saline infusions. During MEG recording, participants completed an emotional evaluation task in which they indicated the sex or emotional valence (happy-neutral or sad-angry) of facial stimuli. Source-localized event-related field (ERF) M100 and M170 amplitudes and latencies were extracted from regions of interest. Linear fixed effects models examined interactions between diagnosis, stimulus valence, and drug session for behavioral and MEG data.
RESULTS


In baseline behavioral analyses, MDD participants exhibited higher accuracy for sad-angry than happy-neutral faces, and HVs responded faster to happy-neutral than sad-angry faces. In the MEG post-infusion analyses, calcarine M100 amplitudes were larger in MDD than HV participants post-placebo but became more similar post-ketamine. Finally, fusiform M170 amplitudes were associated with antidepressant response in MDD participants.
LIMITATIONS


The modest sample size and the need to collapse across responses to happy and neutral faces to increase statistical power limit the generalizability of the findings.
CONCLUSIONS


Ketamine rapidly altered emotional stimulus processing in MDD, laying the groundwork for future investigations of biomarkers of antidepressant treatment response.
CLINICAL TRIAL


Clinicaltrials.gov, NCT#00088699.",2020,"In the MEG post-infusion analyses, calcarine M100 amplitudes were larger in MDD than HV participants post-placebo but became more similar post-ketamine.","['individuals with MDD (n=31) and healthy volunteers (HVs; n=24', 'Major Depressive Disorder', 'individuals with treatment-resistant major depressive disorder (MDD']","[""ketamine's"", 'Ketamine', 'glutamatergic modulator ketamine', 'ketamine', 'Magnetoencephalography (MEG', 'ketamine and placebo-saline infusions', 'placebo']","['Source-localized event-related field (ERF) M100 and M170 amplitudes and latencies', 'sex or emotional valence (happy-neutral or sad-angry) of facial stimuli', 'depressive symptoms']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0024489', 'cui_str': 'Magnetoencephalography'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0085159', 'cui_str': 'Seasonal affective disorder'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",,0.464333,"In the MEG post-infusion analyses, calcarine M100 amplitudes were larger in MDD than HV participants post-placebo but became more similar post-ketamine.","[{'ForeName': 'Nancy B', 'Initials': 'NB', 'LastName': 'Lundin', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, Intramural Research Program, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA;; Department of Psychological and Brain Sciences and Program in Neuroscience, Indiana University, Bloomington, IN, USA.'}, {'ForeName': 'Linnea', 'Initials': 'L', 'LastName': 'Sepe-Forrest', 'Affiliation': 'Department of Psychological and Brain Sciences and Program in Neuroscience, Indiana University, Bloomington, IN, USA;; Magnetoencephalography Core Facility, National Institute of Mental Health, Bethesda, MD, USA.'}, {'ForeName': 'Jessica R', 'Initials': 'JR', 'LastName': 'Gilbert', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, Intramural Research Program, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Frederick W', 'Initials': 'FW', 'LastName': 'Carver', 'Affiliation': 'Magnetoencephalography Core Facility, National Institute of Mental Health, Bethesda, MD, USA.'}, {'ForeName': 'Maura L', 'Initials': 'ML', 'LastName': 'Furey', 'Affiliation': 'Janssen Pharmaceuticals of Johnson and Johnson Inc., San Diego, CA, United States.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Zarate', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, Intramural Research Program, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Allison C', 'Initials': 'AC', 'LastName': 'Nugent', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, Intramural Research Program, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA;; Magnetoencephalography Core Facility, National Institute of Mental Health, Bethesda, MD, USA;. Electronic address: nugenta@mail.nih.gov.'}]",Journal of affective disorders,['10.1016/j.jad.2020.10.007']
1396,33074192,Subthalamic Stimulation Improves Quality of Sleep in Parkinson Disease: A 36-Month Controlled Study.,"BACKGROUND


Sleep disturbances and neuropsychiatric symptoms are some of the most common nonmotor symptoms in Parkinson's disease (PD). The effect of subthalamic stimulation (STN-DBS) on these symptoms beyond a short-term follow-up is unclear.
OBJECTIVE


To examine 36-month effects of bilateral STN-DBS on quality of sleep, depression, anxiety, and quality of life (QoL) compared to standard-of-care medical therapy (MED) in PD.
METHODS


In this prospective, controlled, observational, propensity score matched international multicenter study, we assessed sleep disturbances using the PDSleep Scale-1 (PDSS), QoL employing the PDQuestionnaire-8 (PDQ-8), motor disorder with the Scales for Outcomes in PD (SCOPA), anxiety and depression with the Hospital Anxiety and Depression Scale (HADS), and dopaminergic medication requirements (LEDD). Within-group longitudinal outcome changes were tested using Wilcoxon signed-rank and between-group longitudinal differences of change scores with Mann-Whitney U tests. Spearman correlations analyzed the relationships of outcome parameter changes at follow-up.
RESULTS


Propensity score matching applied on 159 patients (STN-DBS n = 75, MED n = 84) resulted in 40 patients in each treatment group. At 36-month follow-up, STN-DBS led to significantly better PDSS and PDQ-8 change scores, which were significantly correlated. We observed no significant effects for HADS and no significant correlations between change scores in PDSS, HADS, and LEDD.
CONCLUSIONS


We report Class IIb evidence of beneficial effects of STN-DBS on quality of sleep at 36-month follow-up, which were associated with QoL improvement independent of depression and dopaminergic medication. Our study highlights the importance of sleep for assessments of DBS outcomes.",2020,"At 36-month follow-up, STN-DBS led to significantly better PDSS and PDQ-8 change scores, which were significantly correlated.","['Parkinson Disease', ""Parkinson's disease (PD""]","['Subthalamic Stimulation', 'standard-of-care medical therapy (MED) in PD', 'subthalamic stimulation (STN-DBS', 'STN-DBS', 'bilateral STN-DBS']","['quality of sleep', 'PDSS, HADS, and LEDD', 'PDSS and PDQ-8 change scores', 'quality of sleep, depression, anxiety, and quality of life (QoL', 'Quality of Sleep', 'PDSleep Scale-1 (PDSS), QoL employing the PDQuestionnaire-8 (PDQ-8), motor disorder with the Scales for Outcomes in PD (SCOPA), anxiety and depression with the Hospital Anxiety and Depression Scale (HADS), and dopaminergic medication requirements (LEDD']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}]","[{'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0038427', 'cui_str': 'Bruneomycin'}, {'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}]","[{'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0221163', 'cui_str': 'Motor Disorders'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0178601', 'cui_str': 'Dopamine receptor agonist'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",159.0,0.0284462,"At 36-month follow-up, STN-DBS led to significantly better PDSS and PDQ-8 change scores, which were significantly correlated.","[{'ForeName': 'Stefanie T', 'Initials': 'ST', 'LastName': 'Jost', 'Affiliation': 'University of Cologne, Faculty of Medicine and University Hospital Cologne, Department of Neurology, Cologne, Germany.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Ray Chaudhuri', 'Affiliation': ""Parkinson Foundation International Centre of Excellence, King's College Hospital, London, UK.""}, {'ForeName': 'Keyoumars', 'Initials': 'K', 'LastName': 'Ashkan', 'Affiliation': ""Parkinson Foundation International Centre of Excellence, King's College Hospital, London, UK.""}, {'ForeName': 'Philipp A', 'Initials': 'PA', 'LastName': 'Loehrer', 'Affiliation': 'Department of Neurology, University Hospital Giessen and Marburg, Campus Marburg, Marburg, Germany.'}, {'ForeName': 'Monty', 'Initials': 'M', 'LastName': 'Silverdale', 'Affiliation': 'Department of Neurology and Neurosurgery, Salford Royal NHS Foundation Trust, Manchester Academic Health Science Centre, University of Manchester, Greater Manchester, UK.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Rizos', 'Affiliation': ""Parkinson Foundation International Centre of Excellence, King's College Hospital, London, UK.""}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Evans', 'Affiliation': 'Department of Neurology and Neurosurgery, Salford Royal NHS Foundation Trust, Manchester Academic Health Science Centre, University of Manchester, Greater Manchester, UK.'}, {'ForeName': 'Jan Niklas', 'Initials': 'JN', 'LastName': 'Petry-Schmelzer', 'Affiliation': 'University of Cologne, Faculty of Medicine and University Hospital Cologne, Department of Neurology, Cologne, Germany.'}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Barbe', 'Affiliation': 'University of Cologne, Faculty of Medicine and University Hospital Cologne, Department of Neurology, Cologne, Germany.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Sauerbier', 'Affiliation': 'University of Cologne, Faculty of Medicine and University Hospital Cologne, Department of Neurology, Cologne, Germany.'}, {'ForeName': 'Gereon R', 'Initials': 'GR', 'LastName': 'Fink', 'Affiliation': 'University of Cologne, Faculty of Medicine and University Hospital Cologne, Department of Neurology, Cologne, Germany.'}, {'ForeName': 'Veerle', 'Initials': 'V', 'LastName': 'Visser-Vandewalle', 'Affiliation': 'University of Cologne, Faculty of Medicine and University Hospital Cologne, Department of Stereotaxy and Functional Neurosurgery, Cologne, Germany.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Antonini', 'Affiliation': 'Department of Neurosciences (DNS), Padova University, Padova, Italy.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Martinez-Martin', 'Affiliation': 'Center for Networked Biomedical Research in Neurodegenerative Diseases (CIBERNED), Carlos III Institute of Health, Madrid, Spain.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Timmermann', 'Affiliation': 'Department of Neurology, University Hospital Giessen and Marburg, Campus Marburg, Marburg, Germany.'}, {'ForeName': 'Haidar S', 'Initials': 'HS', 'LastName': 'Dafsari', 'Affiliation': 'University of Cologne, Faculty of Medicine and University Hospital Cologne, Department of Neurology, Cologne, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of Parkinson's disease,['10.3233/JPD-202278']
1397,33074196,Effect of head covering on phototherapy induced hypocalcemia in term neonates with hyperbilirubinemia: A randomised controlled study.,"BACKGROUND


Phototherapy is the primary treatment for hyperbilirubinemia in neonates. Hypocalcemia is a lesser known but potential detrimental effect of phototherapy. It has been hypothesized that phototherapy inhibits pineal secretion of melatonin, which blocks the effect of cortisol on bone calcium. Therefore, unchecked cortisol increases bone uptake of calcium and induces hypocalcemia. Covering head during phototherapy in order to prevent light reaching to the pineal gland which eventually leads to the prevention of hypocalcemia is hypothesized to prevent hypocalcemia but it lacks sufficient evidence worldwide.
METHOD


It is a prospective, randomized controlled study. 112 neonates were randomized into two groups of 56 neonates. Group A underwent phototherapy without head cover and group B with head covered by a cap.
RESULT


The mean decline in serum ionic calcium after 48 hours of phototherapy in group A and group B was 0.57±0.37 mg/dl and 0.34±0.24 mg/dl respectively. This decline in serum ionic calcium was significantly higher in group A. (p <  0.001). 26.8% newborns from group A developed hypocalcemia while in group B only 14.3% developed hypocalcemia however it was not found to be statistically significant. Incidence of symptomatic hypocalcemia between the two groups was also not significant.
CONCLUSION


There was significant reduction in serum calcium in neonates undergoing phototherapy without head cover as compared to neonates with head cover but risk of hypocalcemia was not significant. Further studies with larger sample size including preterm are recommended.",2020,There was significant reduction in serum calcium in neonates undergoing phototherapy without head cover as compared to neonates with head cover but risk of hypocalcemia was not significant.,"['term neonates with hyperbilirubinemia', 'hyperbilirubinemia in neonates', '112 neonates']","['phototherapy', 'phototherapy without head cover and group B with head covered by a cap']","['Hypocalcemia', 'serum ionic calcium', 'Incidence of symptomatic hypocalcemia', 'serum calcium', 'hypocalcemia', 'mean decline in serum ionic calcium']","[{'cui': 'C4551581', 'cui_str': 'Term baby'}, {'cui': 'C0020433', 'cui_str': 'Hyperbilirubinemia'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C4319548', 'cui_str': '112'}]","[{'cui': 'C0031765', 'cui_str': 'Light therapy'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}]","[{'cui': 'C0020598', 'cui_str': 'Hypocalcemia'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0728876', 'cui_str': 'Serum calcium measurement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",112.0,0.0451855,There was significant reduction in serum calcium in neonates undergoing phototherapy without head cover as compared to neonates with head cover but risk of hypocalcemia was not significant.,"[{'ForeName': 'I', 'Initials': 'I', 'LastName': 'Asghar', 'Affiliation': 'Department of Pediatrics, Bokaro General Hospital, Bokaro Steel City, Jharkhand, India.'}, {'ForeName': 'I A', 'Initials': 'IA', 'LastName': 'Khan', 'Affiliation': 'Department of Pediatrics, Jawaharlal Nehru Medical College, A.M.U., Aligarh, Uttar Pradesh, India.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Hassan', 'Affiliation': 'Department of Pediatrics, Jawaharlal Nehru Medical College, A.M.U., Aligarh, Uttar Pradesh, India.'}]",Journal of neonatal-perinatal medicine,['10.3233/NPM-200442']
1398,33074208,Performance pay and low-grade stress: An experimental study.,"BACKGROUND


Although recent economics literature suggests a link between performance pay (PRP) and ill health, this finding is contested on the grounds that this link is plagued by endogeneity between the two variables of interest.
OBJECTIVE


This study investigates the adverse effects of performance pay on stress which is an important determinant of physical health.
METHODS


Forty subjects were randomly assigned to two equal groups: either being paid by performance or being paid a flat fee. Both objective (saliva samples to measure cortisol elevation) and subjective (self-reported stress level) measures of stress were obtained before and after participation in the experiment. This experimental methodology purges the effects of self-selection into performance pay and identifies the direction of causation from performance pay to stress which is measured by cortisol levels.
RESULTS


Those who were paid for their performance experienced higher levels of stress, both in terms of perceived stress and in terms of objectively measured cortisol levels, compared to those who were paid a flat fee for minimum performance.
CONCLUSIONS


Performance-related pay induces objectively measurable stress. Self-reported stress levels and the objective stress measure obtained by measuring cortisol move in a similar direction for the PRP and non-PRP groups, but only the cortisol group shows statistically significant differences between the PRP and non-PRP. This also suggests that individuals underestimate the stress caused by performance pay.",2020,"Those who were paid for their performance experienced higher levels of stress, both in terms of perceived stress and in terms of objectively measured cortisol levels, compared to those who were paid a flat fee for minimum performance.
",['Forty subjects'],['being paid by performance or being paid a flat fee'],"['cortisol elevation) and subjective (self-reported stress level) measures of stress', 'Performance pay and low-grade stress']",[],"[{'cui': 'C0205324', 'cui_str': 'Flat'}, {'cui': 'C0015751', 'cui_str': 'Fees'}]","[{'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C1962916', 'cui_str': 'Low grade (lymphoma)'}]",40.0,0.017219,"Those who were paid for their performance experienced higher levels of stress, both in terms of perceived stress and in terms of objectively measured cortisol levels, compared to those who were paid a flat fee for minimum performance.
","[{'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Allan', 'Affiliation': 'Institute for Applied Health Sciences and Aberdeen Health Psychology Group, Health Sciences Building, Foresterhill, University of Aberdeen, UK.'}, {'ForeName': 'Keith A', 'Initials': 'KA', 'LastName': 'Bender', 'Affiliation': 'Department of Economics and Centre for European Labour Market Research, Edward Wright Building, Dunbar Street, Aberdeen, UK.'}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Theodossiou', 'Affiliation': 'Department of Economics and Centre for European Labour Market Research, Edward Wright Building, Dunbar Street, Aberdeen, UK.'}]","Work (Reading, Mass.)",['10.3233/WOR-203294']
1399,33074299,Intraocular Pressure Decrease Does Not Affect Blood Flow Rate of Ophthalmic Artery in Ocular Hypertension.,"Purpose


To investigate if decrease of IOP affects the volumetric blood flow rate in the ophthalmic artery (OA) in patients with previously untreated ocular hypertension.
Methods


Subjects with untreated ocular hypertension (n = 30; mean age 67 ± 8 years; 14 females) underwent ophthalmologic examination and a 3-Tesla magnetic resonance imaging investigation. The magnetic resonance imaging included three-dimensional high-resolution phase-contrast magnetic resonance imaging to measure the OA blood flow rate. The subjects received latanoprost once daily in the eye with higher pressure, the untreated eye served as control. The same measurements were repeated approximately 1 week later.
Results


The mean OA blood flow rate before and after treatment was 12.4 ± 4.4 and 12.4 ± 4.6 mL/min in the treated eye (mean ± SD; P = 0.92) and 13.5 ± 5.2 and 13.4 ± 4.1 mL/min in the control eye (P = 0.92). There was no significant difference between the treated and control eye regarding blood flow rate before (P = 0.13) or after treatment (P = 0.18), or change in blood flow rate after treatment (0.1 ± 3.1 vs. -0.1 ± 4.0 mL/min, P = 0.84). Latanoprost decreased the IOP by 7.2 ± 3.1 mm Hg in the treated eye (P < 0.01).
Conclusions


The results indicate that a significant lowering of IOP does not affect the blood flow rate of the OA in ocular hypertension subjects. The ability to maintain blood supply to the eye independent of the IOP could be a protective mechanism in preserving vision in subjects with ocular hypertension.",2020,"There was no significant difference between the treated and control eye regarding blood flow rate before (P = 0.13) or after treatment (P = 0.18), or change in blood flow rate after treatment (0.1 ± 3.1 vs. -0.1 ± 4.0 mL/min, P = 0.84).","['Methods\n\n\nSubjects with untreated ocular hypertension (n = 30; mean age 67 ± 8 years; 14 females) underwent', 'subjects with ocular hypertension', 'ocular hypertension subjects', 'patients with previously untreated ocular hypertension']","['Latanoprost', 'ophthalmic artery (OA', 'ophthalmologic examination and a 3-Tesla magnetic resonance imaging investigation', 'latanoprost']","['Blood Flow Rate', 'mean OA blood flow rate', 'OA blood flow rate', 'blood flow rate', 'IOP']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0028840', 'cui_str': 'Ocular hypertension'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0090306', 'cui_str': 'latanoprost'}, {'cui': 'C0029078', 'cui_str': 'Structure of ophthalmic artery'}, {'cui': 'C0200149', 'cui_str': 'Ophthalmic examination and evaluation'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C1261322', 'cui_str': 'Evaluation procedure'}]","[{'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0029078', 'cui_str': 'Structure of ophthalmic artery'}, {'cui': 'C0578862', 'cui_str': 'Intraocular pressure finding'}]",,0.0319675,"There was no significant difference between the treated and control eye regarding blood flow rate before (P = 0.13) or after treatment (P = 0.18), or change in blood flow rate after treatment (0.1 ± 3.1 vs. -0.1 ± 4.0 mL/min, P = 0.84).","[{'ForeName': 'Gauti', 'Initials': 'G', 'LastName': 'Jóhannesson', 'Affiliation': 'Department of Clinical Sciences, Ophthalmology, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Qvarlander', 'Affiliation': 'Department of Radiation Sciences, Biomedical Engineering, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Wåhlin', 'Affiliation': 'Department of Radiation Sciences, Biomedical Engineering, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Khalid', 'Initials': 'K', 'LastName': 'Ambarki', 'Affiliation': 'Department of Radiation Sciences, Biomedical Engineering, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Hallberg', 'Affiliation': 'Centre for Biomedical Engineering and Physics, Umeå University, Umeå Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Eklund', 'Affiliation': 'Department of Radiation Sciences, Biomedical Engineering, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Lindén', 'Affiliation': 'Department of Clinical Sciences, Ophthalmology, Umeå University, Umeå, Sweden.'}]",Investigative ophthalmology & visual science,['10.1167/iovs.61.12.17']
1400,33074326,Association of Bevacizumab Plus Oxaliplatin-Based Chemotherapy With Disease-Free Survival and Overall Survival in Patients With Stage II Colon Cancer: A Secondary Analysis of the AVANT Trial.,"Importance


In the pivotal Bevacizumab-Avastin Adjuvant (AVANT) trial, patients with high-risk stage II colon cancer (CC) had 5-year and 10-year overall survival (OS) rates of 88% and 75%, respectively, with adjuvant fluorouracil and oxaliplatin-based chemotherapy; however, the trial did not demonstrate a disease-free survival (DFS) benefit of adding bevacizumab to oxaliplatin-based chemotherapy in stage III CC and suggested a detrimental effect on OS. The Long-term Survival AVANT (S-AVANT) study was designed to collect extended follow-up for patients in the AVANT trial.
Objective


To explore the efficacy of adjuvant bevacizumab combined with oxaliplatin-based chemotherapy in patients with high-risk, stage II CC.
Design, Setting, and Participants


This prespecified secondary end point analysis of the AVANT and S-AVANT studies included 573 patients with curatively resected high-risk stage II CC and at least 1 of the following criteria: stage T4, bowel obstruction or perforation, blood and/or lymphatic vascular invasion and/or perineural invasion, age younger than 50 years, or fewer than 12 nodes analyzed. The AVANT study was a multicenter randomized stage 3 clinical trial. Data were collected from December 2004 to February 2019, and data for this study were analyzed from March to September 2019.
Intervention


Patients were randomly assigned to receive 5-fluorouracil, leucovorin, and oxaliplatin (FOLFOX4), FOLFOX4 with bevacizumab, or capecitabine and oxaliplatin (XELOX) with bevacizumab.
Main Outcomes and Measures


The primary end points of this secondary analysis were DFS and OS in patients with high-risk stage II CC.
Results


The AVANT study included 3451 patients, of whom 573 (16.6%) had high-risk stage II CC (192 [33.5%] randomized to FOLFOX4 group; 194 [33.9%] randomized to FOLFOX4 with bevacizumab group; 187 [32.6%] randomized to XELOX with bevacizumab group). With a median (interquartile range) age of 57.0 (47.2-65.7) years, the study population comprised 325 men (56.7%) and 248 women (43.3%). After a median (interquartile range) follow-up of 6.9 (6.1-11.3) years, the 3-year DFS and 5-year OS rates were 88.2% (95% CI, 83.7%-93.0%) and 89.7% (95% CI, 85.4%-94.2%) in the FOLFOX4 group, 86.6% (95% CI, 81.8%-91.6%) and 89.7% (95% CI, 85.4%-94.2%) in the FOLFOX4 with bevacizumab group, and 86.7% (95% CI, 81.8%-91.8%) and 93.2% (95% CI, 89.6%-97.0%) in the XELOX with bevacizumab group, respectively. The DFS hazard ratio was 0.94 (95% CI, 0.59-1.48; P = .78) for FOLFOX4 with bevacizumab vs FOLFOX4 and 1.07 (95% CI, 0.69-1.67; P = .76) for XELOX with bevacizumab vs FOLFOX4. The OS hazard ratio was 0.92 (95% CI, 0.55-1.55; P = .76) for FOLFOX4 with bevacizumab vs FOLFOX4 and 0.85 (95% CI, 0.50-1.44; P = .55) for XELOX with bevacizumab vs FOLFOX4.
Conclusions and Relevance


In this secondary analysis of data from the AVANT trial, adding bevacizumab to oxaliplatin-based chemotherapy was not associated with longer DFS or OS in patients with high-risk stage II CC. The findings suggest that the definition of high-risk stage II CC needs to be revisited.
Trial Registration


ClinicalTrial.gov Identifiers: AVANT (NCT00112918); S-AVANT (NCT02228668).",2020,"The OS hazard ratio was 0.92 (95% CI, 0.55-1.55; P = .76) for FOLFOX4 with bevacizumab vs FOLFOX4 and 0.85","['573 patients with curatively resected high-risk stage II CC and at least 1 of the following criteria: stage T4, bowel obstruction or perforation, blood and/or lymphatic vascular invasion and/or perineural invasion, age younger than 50 years, or fewer than 12 nodes analyzed', 'Patients With Stage II Colon Cancer', 'patients with high-risk, stage II CC', 'patients with high-risk stage II colon cancer (CC', 'patients with high-risk stage II CC', '3451 patients, of whom 573 (16.6%) had high-risk stage II CC (192 [33.5%] randomized to FOLFOX4 group; 194 [33.9%] randomized to', 'Data were collected from December 2004 to February 2019, and data for this study were analyzed from March to September 2019', 'With a median (interquartile range) age of 57.0 (47.2-65.7) years, the study population comprised 325 men (56.7%) and 248 women (43.3']","['pivotal Bevacizumab-Avastin Adjuvant (AVANT', 'fluorouracil and oxaliplatin-based chemotherapy', 'Bevacizumab Plus Oxaliplatin-Based Chemotherapy', 'XELOX with bevacizumab', 'bevacizumab', 'FOLFOX4 with bevacizumab', 'bevacizumab to oxaliplatin-based chemotherapy', '5-fluorouracil, leucovorin, and oxaliplatin (FOLFOX4), FOLFOX4 with bevacizumab, or capecitabine and oxaliplatin (XELOX) with bevacizumab', 'bevacizumab combined with oxaliplatin-based chemotherapy']","['3-year DFS and 5-year OS rates', 'Disease-Free Survival and Overall Survival', 'DFS or OS', 'DFS hazard ratio', 'OS hazard ratio', '5-year and 10-year overall survival (OS) rates', 'DFS and OS']","[{'cui': 'C4708164', 'cui_str': '573'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0021843', 'cui_str': 'Intestinal obstruction'}, {'cui': 'C0549099', 'cui_str': 'Perforation'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0024235', 'cui_str': 'Structure of lymphatic system'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C1269955', 'cui_str': 'Tumour invasion'}, {'cui': 'C1317608', 'cui_str': 'Perineural spread'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205388', 'cui_str': 'Few'}, {'cui': 'C0278479', 'cui_str': 'Carcinoma of colon, stage II'}, {'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517718', 'cui_str': '33.9'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C4517714', 'cui_str': '325'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C1135130', 'cui_str': 'Avastin'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1956962', 'cui_str': 'XELOX'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",3451.0,0.369923,"The OS hazard ratio was 0.92 (95% CI, 0.55-1.55; P = .76) for FOLFOX4 with bevacizumab vs FOLFOX4 and 0.85","[{'ForeName': 'Benoist', 'Initials': 'B', 'LastName': 'Chibaudel', 'Affiliation': 'Department of Medical Oncology, Franco-British Hospital-Fondation Cognacq-Jay, Levallois-Perret, France.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Henriques', 'Affiliation': 'Methodology and Quality of Life Unit in Oncology, University Hospital of Besançon, Institut National de la Santé et de la Recherche Médicale, Unité Mixte de Recherche 1098, Besançon, France.'}, {'ForeName': 'Manel', 'Initials': 'M', 'LastName': 'Rakez', 'Affiliation': 'Statistical Unit, Aide et Recherche en Cancérologie Digestive, Foundation, Levallois-Perret, France.'}, {'ForeName': 'Baruch', 'Initials': 'B', 'LastName': 'Brenner', 'Affiliation': 'Institute of Oncology, Davidoff Cancer Center, Rabin Medical Center, Petah Tiqva, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Tae Won', 'Initials': 'TW', 'LastName': 'Kim', 'Affiliation': 'Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Mercedes', 'Initials': 'M', 'LastName': 'Martinez-Villacampa', 'Affiliation': ""Department of Medical Oncology, Institut Català d'Oncologia-Bellvitge Institute for Biomedical Research, L'Hospitalet, Barcelona, Spain.""}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Gallego-Plazas', 'Affiliation': 'Department of Medical Oncology, General Universitario de Elche Hospital, Elche, Spain.'}, {'ForeName': 'Andres', 'Initials': 'A', 'LastName': 'Cervantes', 'Affiliation': 'Department of Medical Oncology, Hospital Clinico Universitario de Valencia, Valencia, Spain.'}, {'ForeName': 'Katharine', 'Initials': 'K', 'LastName': 'Shim', 'Affiliation': 'Department of Medical Oncology, Lakeridge Health R.S. McLaughlin Durham Regional Cancer Centre, Oshawa, Ontario, Canada.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Jonker', 'Affiliation': 'Division of Medical Oncology, Department of Medicine, Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Canada.'}, {'ForeName': 'Veronique', 'Initials': 'V', 'LastName': 'Guerin-Meyer', 'Affiliation': ""Department of Gastroenterology and Hepatology, Institut de Cancérologie de l'Ouest Paul Papin, Angers, France.""}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Mineur', 'Affiliation': 'Department of Radiotherapy and Oncology Gastrointestinal and Liver, Institut Sainte Catherine, Avignon, France.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Banzi', 'Affiliation': 'Medical Oncology Unit, Arcispedale Santa Maria Nuova-Istituto di Ricovero e Cura a Carattere Scientifico, Reggio Emilia, Italy.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Dewdney', 'Affiliation': 'Department of Oncology, Weston Park Hospital Cancer Research Centre, Sheffield, United Kingdom.'}, {'ForeName': 'Thitiya', 'Initials': 'T', 'LastName': 'Dejthevaporn', 'Affiliation': 'Medical Oncology Unit, Ramathibodi Hospital, Bangkok, Thailand.'}, {'ForeName': 'Haiko J', 'Initials': 'HJ', 'LastName': 'Bloemendal', 'Affiliation': 'Department of Internal Medicine and Medical Oncology, Radboud University Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Roth', 'Affiliation': 'Digestive Tumor Unit, Department of Oncology, Hôpitaux Universitaires de Genève, Geneva, Switzerland.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Moehler', 'Affiliation': 'First Department of Internal Medicine, University Hospital of Mainz, Mainz, Germany.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Aranda', 'Affiliation': 'Department of Medical Oncology, Reina Sofía University Hospital, Córdoba, Spain.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Van Cutsem', 'Affiliation': 'Department of Gastroenterology and Digestive Oncology, University Hospitals Gasthuisberg/Leuven and KULeuven, Leuven, Belgium.'}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Tabernero', 'Affiliation': ""Department of Medical Oncology, Vall d'Hebron University Hospital and Vall d'Hebron Institute of Oncology, Universitat de Vic-Universitat Central de Catalunya, International Oncology Bureau-Quiron, Barcelona, Spain.""}, {'ForeName': 'Hans-Joachim', 'Initials': 'HJ', 'LastName': 'Schmoll', 'Affiliation': 'Department of Oncology and Hematology, Martin Luther University, Halle, Germany.'}, {'ForeName': 'Paulo M', 'Initials': 'PM', 'LastName': 'Hoff', 'Affiliation': 'Department of Radiology and Oncology, Instituto de Câncer do Estado de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'André', 'Affiliation': 'Department of Medical Oncology, Hôpital Saint-Antoine, Assitance Publique des Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Aimery', 'Initials': 'A', 'LastName': 'de Gramont', 'Affiliation': 'Department of Medical Oncology, Franco-British Hospital-Fondation Cognacq-Jay, Levallois-Perret, France.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.20425']
1401,33074327,Bimagrumab vs Optimized Standard of Care for Treatment of Sarcopenia in Community-Dwelling Older Adults: A Randomized Clinical Trial.,"Importance


The potential benefit of novel skeletal muscle anabolic agents to improve physical function in people with sarcopenia and other muscle wasting diseases is unknown.
Objective


To confirm the safety and efficacy of bimagrumab plus the new standard of care on skeletal muscle mass, strength, and physical function compared with standard of care alone in community-dwelling older adults with sarcopenia.
Design, Setting, and Participants


This double-blind, placebo-controlled, randomized clinical trial was conducted at 38 sites in 13 countries among community-dwelling men and women aged 70 years and older meeting gait speed and skeletal muscle criteria for sarcopenia. The study was conducted from December 2014 to June 2018, and analyses were conducted from August to November 2018.
Interventions


Bimagrumab 700 mg or placebo monthly for 6 months with adequate diet and home-based exercise.
Main Outcomes and Measures


The primary outcome was the change in Short Physical Performance Battery (SPPB) score after 24 weeks of treatment. Secondary outcomes included 6-minute walk distance, usual gait speed, handgrip strength, lean body mass, fat body mass, and standard safety parameters.
Results


A total of 180 participants were recruited, with 113 randomized to bimagrumab and 67 randomized to placebo. Among these, 159 participants (88.3%; mean [SD] age, 79.1 [5.3] years; 109 [60.6%] women) completed the study. The mean SPPB score increased by a mean of 1.34 (95% CI, 0.90 to 1.77) with bimagrumab vs 1.03 (95% CI, 0.53 to 1.52) with placebo (P = .13); 6-minute walk distance increased by a mean of 24.60 (95% CI, 7.65 to 41.56) m with bimagrumab vs 14.30 (95% CI, -4.64 to 33.23) m with placebo (P = .16); and gait speed increased by a mean of 0.14 (95% CI, 0.09 to 0.18) m/s with bimagrumab vs 0.11 (95% CI, 0.05 to 0.16) m/s with placebo (P = .16). Bimagrumab was safe and well-tolerated and increased lean body mass by 7% (95% CI, 6% to 8%) vs 1% (95% CI, 0% to 2%) with placebo, resulting in difference of 6% (95% CI, 4% to 7%) (P < .001).
Conclusions and Relevance


This randomized clinical trial found no significant difference between participants treated with bimagrumab vs placebo among older adults with sarcopenia who had 6 months of adequate nutrition and light exercise, with physical function improving in both groups. Bimagrumab treatment was safe, well-tolerated, increased lean body mass, and decreased fat body mass. The effects of sarcopenia, an increasing cause of disability in older adults, can be reduced with proper diet and exercise.
Trial Registration


ClinicalTrials.gov Identifier: NCT02333331; EudraCT number: 2014-003482-25.",2020,"6-minute walk distance increased by a mean of 24.60 (95% CI, 7.65 to 41.56) m with bimagrumab vs 14.30 (95% CI, -4.64 to 33.23) m with placebo (P = .16); and gait speed increased by a mean of 0.14 (95% CI, 0.09 to 0.18) m/s with bimagrumab vs 0.11 (95% CI, 0.05 to 0.16)","['people with sarcopenia and other muscle wasting diseases', 'December 2014 to June 2018, and analyses were conducted from August to November 2018', 'older adults', 'A total of 180 participants were recruited, with 113 randomized to bimagrumab and 67 randomized to', '13 countries among community-dwelling men and women aged 70 years and older meeting gait speed and skeletal muscle criteria for sarcopenia', 'Community-Dwelling Older Adults', 'community-dwelling older adults with sarcopenia', 'older adults with sarcopenia who had 6 months of adequate nutrition and light exercise', '159 participants (88.3%; mean [SD] age, 79.1 [5.3] years; 109 [60.6%] women) completed the study']","['novel skeletal muscle anabolic agents', 'Bimagrumab 700 mg or placebo', 'Bimagrumab vs Optimized Standard of Care', 'bimagrumab', 'adequate diet and home-based exercise', 'placebo', 'bimagrumab vs placebo']","['6-minute walk distance, usual gait speed, handgrip strength, lean body mass, fat body mass, and standard safety parameters', 'change in Short Physical Performance Battery (SPPB) score', 'mean SPPB score', 'skeletal muscle mass, strength, and physical function', 'safety and efficacy', 'gait speed', 'safe, well-tolerated, increased lean body mass, and decreased fat body mass', 'safe and well-tolerated and increased lean body mass', '6-minute walk distance']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0872084', 'cui_str': 'Sarcopenia'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0043046', 'cui_str': 'Wasting disease'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C3899948', 'cui_str': 'bimagrumab'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0556656', 'cui_str': 'Meetings'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4708663', 'cui_str': '5.3'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C1258800', 'cui_str': 'Anabolic Agents'}, {'cui': 'C3899948', 'cui_str': 'bimagrumab'}, {'cui': 'C4517862', 'cui_str': '700'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C0015665', 'cui_str': 'Fat Body'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4075289', 'cui_str': 'Short Physical Performance Battery score'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}]",180.0,0.472058,"6-minute walk distance increased by a mean of 24.60 (95% CI, 7.65 to 41.56) m with bimagrumab vs 14.30 (95% CI, -4.64 to 33.23) m with placebo (P = .16); and gait speed increased by a mean of 0.14 (95% CI, 0.09 to 0.18) m/s with bimagrumab vs 0.11 (95% CI, 0.05 to 0.16)","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Rooks', 'Affiliation': 'Translational Medicine, Novartis Institutes for BioMedical Research, Cambridge, Massachusetts.'}, {'ForeName': 'Therese', 'Initials': 'T', 'LastName': 'Swan', 'Affiliation': 'Translational Medicine, Novartis Institutes for BioMedical Research, Cambridge, Massachusetts.'}, {'ForeName': 'Budhaditya', 'Initials': 'B', 'LastName': 'Goswami', 'Affiliation': 'Novartis Healthcare, Hyderabad, India.'}, {'ForeName': 'Lee Anne', 'Initials': 'LA', 'LastName': 'Filosa', 'Affiliation': 'Translational Medicine, Novartis Institutes for BioMedical Research, Cambridge, Massachusetts.'}, {'ForeName': 'Ola', 'Initials': 'O', 'LastName': 'Bunte', 'Affiliation': 'Translational Medicine and Musculoskeletal Diseases Research, Novartis Institutes for BioMedical Research, Basel, Switzerland.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Panchaud', 'Affiliation': 'Translational Medicine and Musculoskeletal Diseases Research, Novartis Institutes for BioMedical Research, Basel, Switzerland.'}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Coleman', 'Affiliation': 'Translational Medicine, Novartis Institutes for BioMedical Research, Cambridge, Massachusetts.'}, {'ForeName': 'Ram R', 'Initials': 'RR', 'LastName': 'Miller', 'Affiliation': 'Translational Medicine, Novartis Institutes for BioMedical Research, Cambridge, Massachusetts.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Garcia Garayoa', 'Affiliation': 'Translational Medicine and Musculoskeletal Diseases Research, Novartis Institutes for BioMedical Research, Basel, Switzerland.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Praestgaard', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Perry', 'Affiliation': 'Panax Clinical Research, Miami Lakes, Florida.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Recknor', 'Affiliation': 'Center for Advanced Research and Education, Gainesville, Georgia.'}, {'ForeName': 'Charles M', 'Initials': 'CM', 'LastName': 'Fogarty', 'Affiliation': 'Spartanburg Medical Research, Spartanburg, South Carolina.'}, {'ForeName': 'Hidenori', 'Initials': 'H', 'LastName': 'Arai', 'Affiliation': 'National Center for Geriatrics and Gerontology, Obu, Japan.'}, {'ForeName': 'Liang-Kung', 'Initials': 'LK', 'LastName': 'Chen', 'Affiliation': 'Center for Geriatrics and Gerontology, Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Hashimoto', 'Affiliation': 'National Hospital Organization, Osaka Minami Medical Center, Osaka, Japan.'}, {'ForeName': 'Yoon-Sok', 'Initials': 'YS', 'LastName': 'Chung', 'Affiliation': 'Ajou University School of Medicine, Suwon, South Korea.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Vissing', 'Affiliation': 'Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Laurent', 'Affiliation': 'Translational Medicine and Musculoskeletal Diseases Research, Novartis Institutes for BioMedical Research, Basel, Switzerland.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Petricoul', 'Affiliation': 'Translational Medicine and Musculoskeletal Diseases Research, Novartis Institutes for BioMedical Research, Basel, Switzerland.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Hemsley', 'Affiliation': 'Translational Medicine and Musculoskeletal Diseases Research, Novartis Institutes for BioMedical Research, Basel, Switzerland.'}, {'ForeName': 'Estelle', 'Initials': 'E', 'LastName': 'Lach-Trifilieff', 'Affiliation': 'Translational Medicine and Musculoskeletal Diseases Research, Novartis Institutes for BioMedical Research, Basel, Switzerland.'}, {'ForeName': 'Dimitris A', 'Initials': 'DA', 'LastName': 'Papanicolaou', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.'}, {'ForeName': 'Ronenn', 'Initials': 'R', 'LastName': 'Roubenoff', 'Affiliation': 'Translational Medicine and Musculoskeletal Diseases Research, Novartis Institutes for BioMedical Research, Basel, Switzerland.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.20836']
1402,33074393,Efficacy of high intensity laser therapy in knee osteoarthritis: a double-blind controlled randomized study.,"OBJECTIVE


The aim of this study is to investigate the effectiveness of high intensity laser therapy on pain, functionality, flexion range of motion (FROM), and ultrasonographic cartilage measurement in patients with knee osteoarthritis.
METHODS


This study was designed as a double-blind randomized placebo-controlled study. Forty patients diagnosed with knee osteoarthritis according to the American College of Rheumatology criteria were included in the study. After obtaining written informed consent, patients were randomized into high intensity laser therapy (HILT) + exercise therapy (ET), and placebo laser (PL) + ET groups. Each patient was treated five sessions per week for 2 weeks. The outcomes measured were pain level and functional disability using the visual analog scale (VAS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), respectively. The femoral cartilage thickness measurement was made ultrasonographically, and FROM was measured with goniometry.
RESULTS


Statistically significant improvements were detected in VAS, WOMAC scores, femoral cartilage thickness, and FROM at the end of the treatment (in week 2) compared to the pre-treatment period in both groups (p < 0.05). There were significant decreases in the VAS and WOMAC scores of both groups in the 6th week compared to the pre-treatment period, and the results of the FROM and femur cartilage thickness measurements were increased at statistically significant levels (p < 0.05). The VAS and WOMAC scores were significantly lower in the 6th week in HILT + ET group compared to the PL + ET group (p < 0.05). Similarly, statistically significant increases were detected in the FROM and femur cartilage thickness measurements in HILT + ET group (p < 0.05).
CONCLUSION


HILT + ET combination was more effective in KOA than the PL + ET combination. Key Points • HILT is an effective modality on pain, functional status and FROM in patients with KOA. • HILT is a modality that increases femoral cartilage thickness in patients with KOA.",2020,"There were significant decreases in the VAS and WOMAC scores of both groups in the 6th week compared to the pre-treatment period, and the results of the FROM and femur cartilage thickness measurements were increased at statistically significant levels (p < 0.05).","['Forty patients diagnosed with knee osteoarthritis according to the American College of Rheumatology criteria were included in the study', 'knee osteoarthritis', 'patients with KOA', 'patients with knee osteoarthritis']","['high intensity laser therapy', 'HILT + ET', 'intensity laser therapy (HILT) + exercise therapy (ET), and placebo laser (PL) + ET', 'PL + ET', 'HILT', 'placebo', 'HILT ']","['VAS, WOMAC scores, femoral cartilage thickness, and FROM', 'VAS and WOMAC scores', 'pain, functionality, flexion range of motion (FROM), and ultrasonographic cartilage measurement', 'femoral cartilage thickness measurement', 'Efficacy', 'femoral cartilage thickness', 'pain, functional status and FROM', 'FROM and femur cartilage thickness measurements', 'pain level and functional disability using the visual analog scale (VAS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0007301', 'cui_str': 'Cartilage tissue'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}]",40.0,0.032983,"There were significant decreases in the VAS and WOMAC scores of both groups in the 6th week compared to the pre-treatment period, and the results of the FROM and femur cartilage thickness measurements were increased at statistically significant levels (p < 0.05).","[{'ForeName': 'Mazlum Serdar', 'Initials': 'MS', 'LastName': 'Akaltun', 'Affiliation': 'Faculty of Medicine, Department of Physical Medicine and Rehabilitation, Gaziantep University, Gaziantep, Turkey. mazlum_akaltun@hotmail.com.'}, {'ForeName': 'Ozlem', 'Initials': 'O', 'LastName': 'Altindag', 'Affiliation': 'Faculty of Medicine, Department of Physical Medicine and Rehabilitation, Gaziantep University, Gaziantep, Turkey.'}, {'ForeName': 'Neytullah', 'Initials': 'N', 'LastName': 'Turan', 'Affiliation': 'Faculty of Medicine, Department of Physical Medicine and Rehabilitation, Gaziantep University, Gaziantep, Turkey.'}, {'ForeName': 'Savas', 'Initials': 'S', 'LastName': 'Gursoy', 'Affiliation': 'Faculty of Medicine, Department of Physical Medicine and Rehabilitation, Gaziantep University, Gaziantep, Turkey.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Gur', 'Affiliation': 'Faculty of Medicine, Department of Physical Medicine and Rehabilitation, Gaziantep University, Gaziantep, Turkey.'}]",Clinical rheumatology,['10.1007/s10067-020-05469-7']
1403,33074401,Corticotroph tumor progression during long-term therapy with osilodrostat in a patient with persistent Cushing's disease.,"PURPOSE


Corticotroph tumor progression (CTP) or Nelson's syndrome (NS) can occur in patients with Cushing's disease (CD) following bilateral adrenalectomy. It has rarely been observed in patients treated with long-term medical therapy for persistent CD. Osilodrostat (LCI699) is a new steroidogenesis inhibitor of 11β-hydroxylase (CYP11β1) that induced remission of hypercortisolism in 86% of patients with refractory CD in the randomized placebo-controlled trial LINC-3 (NCT02180217).
METHODS


A 40-year-old woman with persistent CD following transsphenoidal surgery was treated with osilodrostat in the LINC-3 trial and was followed with regular hormonal assessments and imaging of residual corticotroph tumor.
RESULTS


Under oral therapy with osilodrostat 10 mg twice daily, urinary free cortisol (UFC) normalized and clinical signs of CD regressed during therapy. However after 4 years of treatment, ACTH levels increased from 73 to 500 pmol/L and corticotroph tumor size increased rapidly from 3 to 14 mm, while UFCs remained well controlled. Surgical resection of an atypical tumor with weak ACTH expression and increased proliferative index (Ki-67 ≥ 8%) resulted in current remission but will require close follow-up.
CONCLUSION


This case highlights the importance of monitoring ACTH and corticotroph tumor size in patients with persistent CD, either under effective treatment with steroidogenesis inhibitors or after bilateral adrenalectomy.",2020,"Osilodrostat (LCI699) is a new steroidogenesis inhibitor of 11β-hydroxylase (CYP11β1) that induced remission of hypercortisolism in 86% of patients with refractory CD in the randomized placebo-controlled trial LINC-3 (NCT02180217).
","['patients treated with long-term medical therapy for persistent CD', 'patients with persistent CD', ""patients with Cushing's disease (CD) following bilateral adrenalectomy"", 'A 40-year-old woman with persistent CD following transsphenoidal surgery was treated with osilodrostat in the LINC-3 trial and was followed with', ""patient with persistent Cushing's disease""]","['regular hormonal assessments and imaging of residual corticotroph tumor', 'Osilodrostat (LCI699', 'steroidogenesis inhibitors or after bilateral adrenalectomy']","['proliferative index', 'current remission', 'urinary free cortisol (UFC) normalized and clinical signs of CD regressed', 'ACTH levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0221406', 'cui_str': 'Pituitary dependent hypercortisolism'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0193704', 'cui_str': 'Bilateral adrenalectomy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205508', 'cui_str': 'Transsphenoidal approach'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C1707524', 'cui_str': 'Pituitary adrenocorticotropic cell'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C2976005', 'cui_str': 'LCI699'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0193704', 'cui_str': 'Bilateral adrenalectomy'}]","[{'cui': 'C0334094', 'cui_str': 'Proliferation'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0474662', 'cui_str': 'Cortisol measurement, free, urine'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0221406', 'cui_str': 'Pituitary dependent hypercortisolism'}, {'cui': 'C0001655', 'cui_str': 'Corticotropin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0297086,"Osilodrostat (LCI699) is a new steroidogenesis inhibitor of 11β-hydroxylase (CYP11β1) that induced remission of hypercortisolism in 86% of patients with refractory CD in the randomized placebo-controlled trial LINC-3 (NCT02180217).
","[{'ForeName': 'Cédric', 'Initials': 'C', 'LastName': 'Fontaine-Sylvestre', 'Affiliation': ""Division of Endocrinology, Department of Medicine, Centre de Recherche du Centre hospitalier de l'Université de Montréal (CHUM), Université de Montréal, 900 Saint-Denis Street, Montréal, Québec, H2X 0A9, Canada.""}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Létourneau-Guillon', 'Affiliation': ""Neuroradiology Division, Department of Radiology, Centre hospitalier de l'Université de Montréal (CHUM), Université de Montréal, Montréal, Québec, Canada.""}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Moumdjian', 'Affiliation': ""Neurosurgery Division, Department of Surgery, Centre hospitalier de l'Université de Montréal (CHUM), Université de Montréal, Montréal, Québec, Canada.""}, {'ForeName': 'France', 'Initials': 'F', 'LastName': 'Berthelet', 'Affiliation': ""Neuropathology Division, Department of Pathology, Centre hospitalier de l'Université de Montréal (CHUM), Université de Montréal, Montréal, Québec, Canada.""}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Lacroix', 'Affiliation': ""Division of Endocrinology, Department of Medicine, Centre de Recherche du Centre hospitalier de l'Université de Montréal (CHUM), Université de Montréal, 900 Saint-Denis Street, Montréal, Québec, H2X 0A9, Canada. andre.lacroix@umontreal.ca.""}]",Pituitary,['10.1007/s11102-020-01097-1']
1404,33074423,The effect of shock wave lithotripsy and retrograde intrarenal surgery on health-related quality of life in 10-20 mm renal stones: a prospective randomized pilot study.,"The effects of treatment modalities such as retrograde intrarenal surgery (RIRS) and shock wave lithotripsy (SWL) on health-related quality of life (HRQoL) were determined in patients with renal stones between 10 and 20 mm. A total of 120 patients were included in the study and prospectively randomized to RIRS or SWL group. A total of 39 patients experienced treatment failure and finally 81 patients (45 patients in the RIRS group, 36 patients in the SWL group) were analyzed for HRQoL. SF-36 survey was used to determine HRQoL pre-operatively, post-operative day 1 and 1 month. The patient and stone characteristics such as age, gender, stone size, grade of hydronephrosis and body mass index were similar between the two groups. At post-operative day 1, the RIRS group was associated with lower scores of role functioning/physical (p = 0.008), role functioning/emotional (p = 0.047) energy/fatigue (p = 0.011), social functioning (p = 0.003) and pain (p = 0.003) when compared to the SWL group. At post-operative 1 month, only pain and emotional well-being scores (p = 0.012 and p = 0.011, respectively) in the RIRS group were statistically lower according to the SWL group. In our study, patients in the SWL group showed more favorable HRQoL scores when compared to the patients in the RIRS group in short-term follow-up.",2020,"At post-operative 1 month, only pain and emotional well-being scores (p = 0.012 and p = 0.011, respectively) in the RIRS group were statistically lower according to the SWL group.","['patients with renal stones between 10 and 20\xa0mm', 'A total of 120 patients were included in the study and prospectively randomized to RIRS or SWL group', '39 patients experienced treatment failure and finally 81 patients (45 patients in the RIRS group, 36 patients in the SWL group', '10-20\xa0mm renal stones']","['retrograde intrarenal surgery (RIRS) and shock wave lithotripsy (SWL', 'shock wave lithotripsy and retrograde intrarenal surgery']","['favorable HRQoL scores', 'lower scores of role functioning/physical', 'pain and emotional well-being scores', 'health-related quality of life', 'social functioning', 'role functioning/emotional', 'energy/fatigue', 'health-related quality of life (HRQoL', 'pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022650', 'cui_str': 'Kidney stone'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0023878', 'cui_str': 'Lithotripsy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}]","[{'cui': 'C0439784', 'cui_str': 'Retrograde direction'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0023878', 'cui_str': 'Lithotripsy'}]","[{'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",120.0,0.0430142,"At post-operative 1 month, only pain and emotional well-being scores (p = 0.012 and p = 0.011, respectively) in the RIRS group were statistically lower according to the SWL group.","[{'ForeName': 'Gokhan', 'Initials': 'G', 'LastName': 'Atis', 'Affiliation': 'Department of Urology, Faculty of Medicine, Istanbul Medeniyet University, Eğitim Mah. Dr. Erkin Cad. Kadıköy, 34722, Istanbul, Turkey.'}, {'ForeName': 'Meftun', 'Initials': 'M', 'LastName': 'Culpan', 'Affiliation': 'Department of Urology, Faculty of Medicine, Istanbul Medeniyet University, Eğitim Mah. Dr. Erkin Cad. Kadıköy, 34722, Istanbul, Turkey. mculpan@gmail.com.'}, {'ForeName': 'Taha', 'Initials': 'T', 'LastName': 'Ucar', 'Affiliation': 'Department of Urology, Faculty of Medicine, Istanbul Medeniyet University, Eğitim Mah. Dr. Erkin Cad. Kadıköy, 34722, Istanbul, Turkey.'}, {'ForeName': 'Furkan', 'Initials': 'F', 'LastName': 'Sendogan', 'Affiliation': 'Department of Urology, Ardahan State Hospital, Ardahan, Turkey.'}, {'ForeName': 'Huseyin Ozgur', 'Initials': 'HO', 'LastName': 'Kazan', 'Affiliation': 'Department of Urology, Faculty of Medicine, Istanbul Medeniyet University, Eğitim Mah. Dr. Erkin Cad. Kadıköy, 34722, Istanbul, Turkey.'}, {'ForeName': 'Asif', 'Initials': 'A', 'LastName': 'Yildirim', 'Affiliation': 'Department of Urology, Faculty of Medicine, Istanbul Medeniyet University, Eğitim Mah. Dr. Erkin Cad. Kadıköy, 34722, Istanbul, Turkey.'}]",Urolithiasis,['10.1007/s00240-020-01219-1']
1405,33074442,Novel adjuvant dendritic cell therapy with transfection of heat-shock protein 70 messenger RNA for patients with hepatocellular carcinoma: a phase I/II prospective randomized controlled clinical trial.,"INTRODUCTION


A proteomic analysis of hepatocellular carcinoma (HCC) has revealed that Heat Shock Protein 70 (HSP70) is among the cancer antigen proteins of HCC. Moreover, we confirmed that HSP70 was highly expressed in HCC by immunohistochemical staining. Based on these results, we developed an HSP70 mRNA-transfected dendritic cell (DC) therapy for treating unresectable or recurrent HCC, and the phase I trial was completed successfully. Thus, we aimed to investigate the safety and efficacy of this therapy as a postoperative adjuvant treatment after curative resection for HCC to prevent recurrence by conducting a phase I/II randomized controlled clinical trial.
METHODS


Patients (n = 45) with resectable HCC of stages II-IVa were registered and randomly assigned into two groups (DC group: 31 patients, control group: 14 patients) before surgery. The primary endpoint was disease-free survival (DFS), and the secondary endpoints were safety and overall survival. The DC therapy was initially administered at approximately 1 week after surgery, and twice every 3-4 weeks thereafter.
RESULTS


No adverse events specific to the immunotherapy were observed in the DC group. There was no difference in DFS between the DC and control groups (p = 0.666). However, in the subgroup with HSP70-expressing HCC, DFS of the DC group tended to be better (p = 0.090) and OS of the DC group was significantly longer (p = 0.003) than those of the control group.
CONCLUSION


The HSP70 mRNA-transfected DC therapy was performed safely as an adjuvant therapy. The prognosis of HSP70-expressing HCC cases could be expected to improve with this therapy.",2020,There was no difference in DFS between the DC and control groups (p = 0.666).,"['hepatocellular carcinoma (HCC', 'patients with hepatocellular carcinoma', 'Patients (n\u2009=\u200945) with resectable HCC of stages II-IVa']","['HSP70 mRNA-transfected dendritic cell (DC) therapy', 'Novel adjuvant dendritic cell therapy with transfection of heat-shock protein 70 messenger RNA', 'HSP70 mRNA-transfected DC therapy']","['disease-free survival (DFS', 'safety and overall survival', 'safety and efficacy', 'DFS']","[{'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0863194', 'cui_str': 'Hepatoma resectable'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0268575', 'cui_str': 'Isovaleryl-CoA dehydrogenase deficiency'}]","[{'cui': 'C0243043', 'cui_str': 'Heat-Shock Proteins 70'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0003315', 'cui_str': 'Immunologic Accessory Cells'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0040669', 'cui_str': 'Transfection'}]","[{'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.0558672,There was no difference in DFS between the DC and control groups (p = 0.666).,"[{'ForeName': 'Hiroto Matsui', 'Initials': 'HM', 'LastName': 'Matsui', 'Affiliation': 'Department of Gastroenterological, Breast and Endocrine Surgery, Yamaguchi University Graduate School of Medicine, 1-1-1 Minami-Kogushi, Ube, Yamaguchi, 755-8505, Japan.'}, {'ForeName': 'Shoichi', 'Initials': 'S', 'LastName': 'Hazama', 'Affiliation': 'Department of Gastroenterological, Breast and Endocrine Surgery, Yamaguchi University Graduate School of Medicine, 1-1-1 Minami-Kogushi, Ube, Yamaguchi, 755-8505, Japan.'}, {'ForeName': 'Masao', 'Initials': 'M', 'LastName': 'Nakajima', 'Affiliation': 'Department of Gastroenterological, Breast and Endocrine Surgery, Yamaguchi University Graduate School of Medicine, 1-1-1 Minami-Kogushi, Ube, Yamaguchi, 755-8505, Japan.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Xu', 'Affiliation': 'Department of Gastroenterological, Breast and Endocrine Surgery, Yamaguchi University Graduate School of Medicine, 1-1-1 Minami-Kogushi, Ube, Yamaguchi, 755-8505, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Matsukuma', 'Affiliation': 'Department of Gastroenterological, Breast and Endocrine Surgery, Yamaguchi University Graduate School of Medicine, 1-1-1 Minami-Kogushi, Ube, Yamaguchi, 755-8505, Japan.'}, {'ForeName': 'Yukio', 'Initials': 'Y', 'LastName': 'Tokumitsu', 'Affiliation': 'Department of Gastroenterological, Breast and Endocrine Surgery, Yamaguchi University Graduate School of Medicine, 1-1-1 Minami-Kogushi, Ube, Yamaguchi, 755-8505, Japan.'}, {'ForeName': 'Yoshitaro', 'Initials': 'Y', 'LastName': 'Shindo', 'Affiliation': 'Department of Gastroenterological, Breast and Endocrine Surgery, Yamaguchi University Graduate School of Medicine, 1-1-1 Minami-Kogushi, Ube, Yamaguchi, 755-8505, Japan.'}, {'ForeName': 'Shinobu', 'Initials': 'S', 'LastName': 'Tomochika', 'Affiliation': 'Department of Gastroenterological, Breast and Endocrine Surgery, Yamaguchi University Graduate School of Medicine, 1-1-1 Minami-Kogushi, Ube, Yamaguchi, 755-8505, Japan.'}, {'ForeName': 'Shin', 'Initials': 'S', 'LastName': 'Yoshida', 'Affiliation': 'Department of Gastroenterological, Breast and Endocrine Surgery, Yamaguchi University Graduate School of Medicine, 1-1-1 Minami-Kogushi, Ube, Yamaguchi, 755-8505, Japan.'}, {'ForeName': 'Michihisa', 'Initials': 'M', 'LastName': 'Iida', 'Affiliation': 'Department of Gastroenterological, Breast and Endocrine Surgery, Yamaguchi University Graduate School of Medicine, 1-1-1 Minami-Kogushi, Ube, Yamaguchi, 755-8505, Japan.'}, {'ForeName': 'Nobuaki', 'Initials': 'N', 'LastName': 'Suzuki', 'Affiliation': 'Department of Gastroenterological, Breast and Endocrine Surgery, Yamaguchi University Graduate School of Medicine, 1-1-1 Minami-Kogushi, Ube, Yamaguchi, 755-8505, Japan.'}, {'ForeName': 'Shigeru', 'Initials': 'S', 'LastName': 'Takeda', 'Affiliation': 'Department of Gastroenterological, Breast and Endocrine Surgery, Yamaguchi University Graduate School of Medicine, 1-1-1 Minami-Kogushi, Ube, Yamaguchi, 755-8505, Japan.'}, {'ForeName': 'Shigefumi', 'Initials': 'S', 'LastName': 'Yoshino', 'Affiliation': 'Department of Gastroenterological, Breast and Endocrine Surgery, Yamaguchi University Graduate School of Medicine, 1-1-1 Minami-Kogushi, Ube, Yamaguchi, 755-8505, Japan.'}, {'ForeName': 'Tomio', 'Initials': 'T', 'LastName': 'Ueno', 'Affiliation': 'Department of Digestive Surgery, Kawasaki Medical School, Kurashiki, Okayama, Japan.'}, {'ForeName': 'Masaaki', 'Initials': 'M', 'LastName': 'Oka', 'Affiliation': 'Yamaguchi University, Yamaguchi, Yamaguchi, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Nagano', 'Affiliation': 'Department of Gastroenterological, Breast and Endocrine Surgery, Yamaguchi University Graduate School of Medicine, 1-1-1 Minami-Kogushi, Ube, Yamaguchi, 755-8505, Japan. hnagano@yamaguchi-u.ac.jp.'}]","Cancer immunology, immunotherapy : CII",['10.1007/s00262-020-02737-y']
1406,33074557,"Efficacy and safety of once-weekly semaglutide vs once-daily sitagliptin as add-on to metformin in patients with type 2 diabetes (SUSTAIN China): a 30-week double-blind, phase 3a, randomised trial.","AIM


To evaluate the efficacy and safety of once-weekly subcutaneous (s.c.) semaglutide, a glucagon-like-peptide-1 (GLP-1) analogue, versus once-daily sitagliptin as add-on to metformin in patients with type 2 diabetes (T2D) in a multi-regional clinical trial, with ~70% (605/868) of patients enrolled in region China and the remaining patients in four other countries, including Republic of Korea.
MATERIALS AND METHODS


In this 30-week, randomised, double-blind, double-dummy, active comparator trial, adults with T2D inadequately controlled on metformin (glycated haemoglobin [HbA 1c  ] 7.0-10.5%) were randomised to receive once-weekly semaglutide 0.5 mg (n=287), semaglutide 1.0 mg (n=290) or once-daily sitagliptin 100 mg (n=290). The primary and confirmatory secondary endpoints were change in HbA 1c  and body weight, respectively.
RESULTS


Both doses of semaglutide were superior to sitagliptin in reducing HbA 1c  and body weight after 30 weeks of treatment. The odds for achieving target HbA 1c  <7.0% (53 mmol/mol), weight loss of ≥5% or ≥10% and the composite endpoint of HbA 1c  <7.0% (53 mmol/mol) without severe or blood glucose (BG)-confirmed symptomatic hypoglycaemia and no weight gain were all significantly higher with both semaglutide doses compared to sitagliptin. The safety profile for semaglutide was consistent with the known class effects of GLP-1 receptor agonists (RAs). Consistent efficacy and safety findings were seen in the Chinese population.
CONCLUSIONS


Once-weekly semaglutide was superior to sitagliptin in improving glycaemic control and reducing body weight in patients with T2D inadequately controlled on metformin. The safety and tolerability profiles were consistent with that of semaglutide and other GLP-1 RAs. Semaglutide is an effective once-weekly treatment option for the Chinese population. This article is protected by copyright. All rights reserved.",2020,Both doses of semaglutide were superior to sitagliptin in reducing HbA 1c  and body weight after 30 weeks of treatment.,"['patients with T2D inadequately controlled on', 'patients with type 2 diabetes (T2D) in a multi-regional clinical trial, with ~70', 'patients with type 2 diabetes (SUSTAIN China', 'adults with T2D inadequately controlled on']","['metformin (glycated haemoglobin ', 'metformin', 'once-weekly subcutaneous (s.c.) semaglutide, a glucagon-like-peptide-1 (GLP-1) analogue', 'semaglutide 1.0 mg (n=290) or once-daily sitagliptin', 'Semaglutide']","['weight loss', 'efficacy and safety', 'HbA 1c  and body weight', 'change in HbA 1c  and body weight, respectively', 'safety and tolerability profiles', 'Efficacy and safety', 'body weight', 'severe or blood glucose (BG)-confirmed symptomatic hypoglycaemia and no weight gain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0558293', 'cui_str': 'Once a week'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}]",,0.204677,Both doses of semaglutide were superior to sitagliptin in reducing HbA 1c  and body weight after 30 weeks of treatment.,"[{'ForeName': 'Linong', 'Initials': 'L', 'LastName': 'Ji', 'Affiliation': ""Peking University People's Hospital No. 11 Xi zhi men South Street Xicheng District Beijing, BJ, China.""}, {'ForeName': 'Xiaolin', 'Initials': 'X', 'LastName': 'Dong', 'Affiliation': 'Jinan Central Hospital Affiliated to Shandong University No. 105 Jiefang Road Jinan, CN, China.'}, {'ForeName': 'Yiming', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Shanghai Huashan Hospital, Affiliated to Fudan University No. 12 Wulumuqi Zhong Road Shanghai, SH, China.'}, {'ForeName': 'Yufeng', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Beijing Pinggu Hospital, China.'}, {'ForeName': 'Soo', 'Initials': 'S', 'LastName': 'Lim', 'Affiliation': 'Department of Internal Medicine, Seoul National University College of Medicine, Seongnam, South Korea.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'General Hospital of Tianjin Medical University No. 154, Anshan, TJ, China.'}, {'ForeName': 'Zu', 'Initials': 'Z', 'LastName': 'Ning', 'Affiliation': 'Novo Nordisk (China) Pharmaceuticals Co., Ltd, Beijing, China.'}, {'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Rasmussen', 'Affiliation': 'Novo Nordisk A/S, Copenhagen, Denmark.'}, {'ForeName': 'Trine', 'Initials': 'T', 'LastName': 'Vang Skjøth', 'Affiliation': 'Novo Nordisk A/S, Copenhagen, Denmark.'}, {'ForeName': 'Guoyue', 'Initials': 'G', 'LastName': 'Yuan', 'Affiliation': 'The Affiliated Hospital of Jiangsu University No. 438 Jiefang Rd. Zhenjiang, JS, China.'}, {'ForeName': 'Freddy G', 'Initials': 'FG', 'LastName': 'Eliaschewitz', 'Affiliation': 'CPClin/DASA Centro de Pesquisas Clínicas, São Paulo, SP, Brazil.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14232']
1407,33069301,"Cytisine for smoking cessation in patients with tuberculosis: a multicentre, randomised, double-blind, placebo-controlled phase 3 trial.","BACKGROUND


Smoking cessation is important in patients with tuberculosis because it can reduce the high rates of treatment failure and mortality. We aimed to assess the effectiveness and safety of cystine as a smoking cessation aid in patients with tuberculosis in Bangladesh and Pakistan.
METHODS


We did a randomised, double-blind, placebo-controlled, trial at 32 health centres in Bangladesh and Pakistan. Eligible patients were adults (aged >18 years in Bangladesh; aged >15 years in Pakistan) with pulmonary tuberculosis diagnosed in the previous 4 weeks, who smoked tobacco on a daily basis and were willing to stop smoking. Patients were randomly assigned (1:1) to receive behavioural support plus either oral cytisine (9 mg on day 0, which was gradually reduced to 1·5 mg by day 25) or placebo for 25 days. Randomisation was done using pregenerated block randomisation lists, stratified by trial sites. Investigators, clinicians, and patients were masked to treatment allocation. The primary outcome was continuous abstinence at 6 months, defined as self-report (of not having used more than five cigarettes, bidis, a water pipe, or smokeless tobacco products since the quit date), confirmed biochemically by a breath carbon monoxide reading of less than 10 parts per million. Primary and safety analysis were done in the intention-to-treat population. This trial is registered with the International Standard Randomised Clinical Trial Registry, ISRCTN43811467, and enrolment is complete.
FINDINGS


Between June 6, 2017, and April 30, 2018, 2472 patients (1527 patients from Bangladesh; 945 patients from Pakistan) were enrolled and randomly assigned to receive cytisine (n=1239) or placebo (n=1233). At 6 months, 401 (32·4%) participants in the cytisine group and 366 (29·7%) participants in the placebo group had achieved continuous abstinence (risk difference 2·68%, 95% CI -0·96 to 6·33; relative risk 1·09, 95% CI 0·97 to 1·23, p=0·114). 53 (4·3%) of 1239 participants in the cytisine group and 46 (3·7%) of 1233 participants in the placebo group reported serious adverse events (94 events in the cytisine group and 90 events in the placebo group), which included 91 deaths (49 in the cytisine group and 42 in the placebo group). None of the adverse events were attributed to the study medication.
INTERPRETATION


Our findings do not support the addition of cytisine to brief behavioural support for the treatment of tobacco dependence in patients with tuberculosis.
FUNDING


European Union Horizon 2020 and Health Data Research UK.
TRANSLATIONS


For the Bengali and Urdu translations of the abstract see Supplementary Materials section.",2020,"Our findings do not support the addition of cytisine to brief behavioural support for the treatment of tobacco dependence in patients with tuberculosis.
","['53', 'patients with tuberculosis', 'Between June 6, 2017, and April 30, 2018, 2472 patients (1527 patients from Bangladesh; 945 patients from Pakistan', 'Eligible patients were adults (aged >18 years in Bangladesh; aged >15 years in Pakistan) with pulmonary tuberculosis diagnosed in the previous 4 weeks, who smoked tobacco on a daily basis and were willing to stop smoking', '32 health centres in Bangladesh and Pakistan', 'patients with tuberculosis in Bangladesh and Pakistan']","['cystine', 'behavioural support plus either oral cytisine', 'placebo', 'Cytisine', 'cytisine']","['continuous abstinence at 6 months, defined as self-report (of not having used more than five cigarettes, bidis, a water pipe, or smokeless tobacco products since the quit date', 'continuous abstinence', 'serious adverse events', 'breath carbon monoxide reading']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0041327', 'cui_str': 'Pulmonary tuberculosis'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0439994', 'cui_str': 'Tobacco smoke'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0600109', 'cui_str': 'Willing'}, {'cui': 'C0425310', 'cui_str': 'Stopped smoking'}, {'cui': 'C0475309', 'cui_str': 'Health center'}]","[{'cui': 'C0010682', 'cui_str': 'Cystine'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0056913', 'cui_str': 'cytisine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C2984220', 'cui_str': 'Bidis Tobacco'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0071109', 'cui_str': ""piperazine-N,N'-bis(2-ethanesulfonic acid)""}, {'cui': 'C0040338', 'cui_str': 'Smokeless Tobacco'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0225386', 'cui_str': 'Breath'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0034754', 'cui_str': 'Reading'}]",2472.0,0.753733,"Our findings do not support the addition of cytisine to brief behavioural support for the treatment of tobacco dependence in patients with tuberculosis.
","[{'ForeName': 'Omara', 'Initials': 'O', 'LastName': 'Dogar', 'Affiliation': 'Department of Health Sciences, Faculty of Sciences, University of York, York, UK; Usher Institute, University of Edinburgh, Edinburgh, UK. Electronic address: omara.dogar@york.ac.uk.'}, {'ForeName': 'Ada', 'Initials': 'A', 'LastName': 'Keding', 'Affiliation': 'Department of Health Sciences, Faculty of Sciences, University of York, York, UK.'}, {'ForeName': 'Rhian', 'Initials': 'R', 'LastName': 'Gabe', 'Affiliation': 'Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, UK.'}, {'ForeName': 'Anna-Marie', 'Initials': 'AM', 'LastName': 'Marshall', 'Affiliation': 'Department of Health Sciences, Faculty of Sciences, University of York, York, UK.'}, {'ForeName': 'Rumana', 'Initials': 'R', 'LastName': 'Huque', 'Affiliation': 'ARK Foundation, Dhaka, Bangladesh; Department of Economics, University of Dhaka, Dhaka, Bangladesh.'}, {'ForeName': 'Deepa', 'Initials': 'D', 'LastName': 'Barua', 'Affiliation': 'ARK Foundation, Dhaka, Bangladesh.'}, {'ForeName': 'Razia', 'Initials': 'R', 'LastName': 'Fatima', 'Affiliation': 'Common Management Unit (TB, HIV/AIDS and Malaria), Islamabad, Pakistan.'}, {'ForeName': 'Amina', 'Initials': 'A', 'LastName': 'Khan', 'Affiliation': 'The Initiative, Islamabad, Pakistan.'}, {'ForeName': 'Raana', 'Initials': 'R', 'LastName': 'Zahid', 'Affiliation': 'The Initiative, Islamabad, Pakistan.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Mansoor', 'Affiliation': 'Institute of Psychiatry, Rawalpindi Medical University, Rawalpindi, Pakistan.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Kotz', 'Affiliation': 'Usher Institute, University of Edinburgh, Edinburgh, UK; Addiction Research and Clinical Epidemiology Unit, Institute of General Practice, Centre for Health and Society, Heinrich-Heine-University, Düsseldorf, Germany; Department of Family Medicine, Care and Public Health Research Institute, Maastricht University, Maastricht, Netherlands.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Boeckmann', 'Affiliation': 'Department of Health Sciences, Faculty of Sciences, University of York, York, UK; Addiction Research and Clinical Epidemiology Unit, Institute of General Practice, Centre for Health and Society, Heinrich-Heine-University, Düsseldorf, Germany; Department of Environment and Health, School of Public Health, Bielefeld University, Bielefeld, Germany.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Elsey', 'Affiliation': 'Department of Health Sciences, Faculty of Sciences, University of York, York, UK.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Kralikova', 'Affiliation': '3rd Medical Department, First Faculty of Medicine, Charles University and General University Hospital, Prague, Czech Republic; Institute of Hygiene and Epidemiology, First Faculty of Medicine, Charles University and General University Hospital, Prague, Czech Republic.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Parrott', 'Affiliation': 'Department of Health Sciences, Faculty of Sciences, University of York, York, UK.'}, {'ForeName': 'Jinshuo', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Health Sciences, Faculty of Sciences, University of York, York, UK.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Readshaw', 'Affiliation': 'Department of Health Sciences, Faculty of Sciences, University of York, York, UK.'}, {'ForeName': 'Aziz', 'Initials': 'A', 'LastName': 'Sheikh', 'Affiliation': 'Usher Institute, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Kamran', 'Initials': 'K', 'LastName': 'Siddiqi', 'Affiliation': 'Department of Health Sciences, Faculty of Sciences, University of York, York, UK; Hull York Medical School, University of York, York, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Global health,['10.1016/S2214-109X(20)30312-0']
1408,33069302,"Patterns of individual non-treatment during multiple rounds of mass drug administration for control of soil-transmitted helminths in the TUMIKIA trial, Kenya: a secondary longitudinal analysis.","BACKGROUND


Few studies have been done of patterns of treatment during mass drug administration (MDA) to control neglected tropical diseases. We used routinely collected individual-level treatment records that had been collated for the Tuangamize Minyoo Kenya Imarisha Afya (Swahili for Eradicate Worms in Kenya for Better Health [TUMIKIA]) trial, done in coastal Kenya from 2015 to 2017. In this analysis we estimate the extent of and factors associated with the same individuals not being treated over multiple rounds of MDA, which we term systematic non-treatment.
METHODS


We linked the baseline population of the TUMIKIA trial randomly assigned to receive biannual community-wide MDA for soil-transmitted helminthiasis to longitudinal records on receipt of treatment in any of the four treatment rounds of the study. We fitted logistic regression models to estimate the association of non-treatment in a given round with non-treatment in the previous round, controlling for identified predictors of non-treatment. We also used multinomial logistic regression to identify factors associated with part or no treatment versus complete treatment.
FINDINGS


36 327 participants were included in our analysis: 16 236 children aged 2-14 years and 20 091 adults aged 15 years or older. The odds of having no treatment recorded was higher if a participant was not treated during the previous round of MDA (adjusted odds ratio [OR] 3·60, 95% CI 3·08-4·20 for children and 5·58, 5·01-6·21 for adults). For children, school attendance and rural residence reduced the odds of receiving part or no treatment, whereas odds were increased by least poor socioeconomic status and living in an urban or periurban household. Women had higher odds than men of receiving part or no treatment. However, when those with pregnancy or childbirth in the previous 2 weeks were excluded, women became more likely to receive complete treatment. Adults aged 20-25 years were the age group with the highest odds of receiving part (OR 1·41, 95% CI 1·22-1·63) or no treatment (OR 1·81, 95% CI 1·53-2·14).
INTERPRETATION


Non-treatment was associated with specific sociodemographic groups and characteristics and did not occcur at random. This finding has important implications for MDA programme effectiveness, the relevance of which will intensify as disease prevalence decreases and infections become increasingly clustered.
FUNDING


Bill & Melinda Gates Foundation, Joint Global Health Trials Scheme of the Medical Research Council, UK Department for International Development, Wellcome Trust, Children's Investment Fund Foundation, and London Centre for Neglected Tropical Diseases.",2020,"For children, school attendance and rural residence reduced the odds of receiving part or no treatment, whereas odds were increased by least poor socioeconomic status and living in an urban or periurban household.","['327 participants were included in our analysis: 16\u2008236 children aged 2-14 years and 20\u2008091 adults aged 15 years or older', '36', 'Adults aged 20-25 years were the age group with the highest odds of receiving part (OR 1·41, 95% CI 1·22-1·63) or no treatment (OR 1·81, 95% CI 1·53-2·14', 'routinely collected individual-level treatment records that had been collated for the Tuangamize Minyoo Kenya Imarisha Afya (Swahili for Eradicate Worms in Kenya for Better Health [TUMIKIA]) trial, done in coastal Kenya from 2015 to 2017', 'Women had higher odds than men of receiving part or no treatment']",['biannual community-wide MDA'],[],"[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C0038977', 'cui_str': 'Swahili language'}, {'cui': 'C0018889', 'cui_str': 'Helminth infection'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C4505223', 'cui_str': 'Mass Administration'}]",[],36327.0,0.0564094,"For children, school attendance and rural residence reduced the odds of receiving part or no treatment, whereas odds were increased by least poor socioeconomic status and living in an urban or periurban household.","[{'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Oswald', 'Affiliation': 'Department of Disease Control, Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, London, UK. Electronic address: william.oswald@lshtm.ac.uk.'}, {'ForeName': 'Stella', 'Initials': 'S', 'LastName': 'Kepha', 'Affiliation': 'Department of Disease Control, Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, London, UK; Eastern and Southern Africa Centre of International Parasite Control, Kenya Medical Research Institute, Nairobi, Kenya; Pwani University Bioscience Research Centre, Pwani University, Kilifi, Kenya.'}, {'ForeName': 'Katherine E', 'Initials': 'KE', 'LastName': 'Halliday', 'Affiliation': 'Department of Disease Control, Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Mcharo', 'Affiliation': 'Eastern and Southern Africa Centre of International Parasite Control, Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': ""Th'uva"", 'Initials': 'T', 'LastName': 'Safari', 'Affiliation': 'Eastern and Southern Africa Centre of International Parasite Control, Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Witek-McManus', 'Affiliation': 'Department of Disease Control, Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Hardwick', 'Affiliation': ""London Centre for Neglected Tropical Disease Research, Faculty of Medicine, Department of Infectious Disease Epidemiology, School of Public Health, St Mary's Campus, Imperial College London, London, UK.""}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Allen', 'Affiliation': 'Department of Medical Statistics, Faculty of Epidemiology and Population Health, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Sultani H', 'Initials': 'SH', 'LastName': 'Matendechero', 'Affiliation': 'Neglected Tropical Diseases Unit, Division of Communicable Disease Prevention and Control, Ministry of Health, Nairobi, Kenya.'}, {'ForeName': 'Simon J', 'Initials': 'SJ', 'LastName': 'Brooker', 'Affiliation': 'Department of Disease Control, Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Sammy M', 'Initials': 'SM', 'LastName': 'Njenga', 'Affiliation': 'Eastern and Southern Africa Centre of International Parasite Control, Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Charles S', 'Initials': 'CS', 'LastName': 'Mwandawiro', 'Affiliation': 'Eastern and Southern Africa Centre of International Parasite Control, Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Roy M', 'Initials': 'RM', 'LastName': 'Anderson', 'Affiliation': ""London Centre for Neglected Tropical Disease Research, Faculty of Medicine, Department of Infectious Disease Epidemiology, School of Public Health, St Mary's Campus, Imperial College London, London, UK.""}, {'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'Pullan', 'Affiliation': 'Department of Disease Control, Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, London, UK.'}]",The Lancet. Global health,['10.1016/S2214-109X(20)30344-2']
1409,33069317,"Amisulpride, aripiprazole, and olanzapine in patients with schizophrenia-spectrum disorders (BeSt InTro): a pragmatic, rater-blind, semi-randomised trial.","BACKGROUND


Amisulpride, aripiprazole, and olanzapine are first-line atypical antipsychotics that have not previously been compared head-to-head in a pragmatic trial. We aimed to compare the efficacy and safety of these agents in a controlled trial.
METHODS


This pragmatic, rater-blind, randomised controlled trial was done in three academic centres of psychiatry in Norway, and one in Austria. Eligible patients were aged 18 years or older, met ICD-10 criteria for schizophrenia-spectrum disorders (F20-29), and had symptoms of active psychosis. Eligible patients were randomly assigned to receive oral amisulpride, aripiprazole, or olanzapine. Treatment allocation was open to patients and staff, and starting dose, treatment changes, and adjustments were left to the discretion of the treating physician. Computer-generated randomisation lists for each study centre were prepared by independent statisticians. Patients were followed up for 52 weeks after random assignment, during which assessments were done 8 times by researchers masked to treatment. The primary outcome was reduction of the Positive And Negative Syndrome Scale (PANSS) total score at 52 weeks, and primary analyses were done in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, number NCT01446328.
FINDINGS


Between Oct 20, 2011, and Dec 30, 2016, we assessed 359 patients for eligibility. 215 patients were excluded (107 did not meet inclusion criteria, 82 declined to participate, 26 other reasons). 144 patients (mean baseline PANSS total estimated score 78·4 [SD 1·4]) were randomly assigned 1:1:1 to receive amisulpride (44 patients), aripiprazole (48 patients) or olanzapine (52 patients). After 52 weeks, the patients allocated to amisulpride had a PANSS total score reduction of 32·7 points (SD 3·1) compared with 21·9 points reduction with aripiprazole (SD 3·9, p=0·027) and 23·3 points with olanzapine (2·9, p=0·025). We observed weight gain and increases of serum lipids and prolactin in all groups. 26 serious adverse events (SAEs) among 20 patients were registered (four [9%] of 44 patients allocated to amisulpride, ten [21%] of 48 patients allocated to aripiprazole, and six [12%] of 52 patients allocated to olanzapine), with no statistically significant differences between the study drugs. 17 (65%) of the 26 SAEs occurred during the use of the study drug, with readmission or protracted hospital admission accounting for 13 SAEs. One death by suicide, one unspecified death, and one life-threatening accident occurred during follow-up, after cessation of treatment.
INTERPRETATION


Amisulpride was more efficacious than aripiprazole or olanzapine for reducing the PANSS total scores in adults with schizophrenia-spectrum disorders. Side-effect differences among the groups were generally small. This study supports the notion that clinically relevant efficacy differences exist between antipsychotic drugs. Future research should aim to compare first-line antipsychotics directly in pragmatic clinical trials that reflect everyday clinical practice.
FUNDING


The Research Council of Norway, the Western Norway Regional Health Trust, and participating hospitals and universities.",2020,"INTERPRETATION


Amisulpride was more efficacious than aripiprazole or olanzapine for reducing the PANSS total scores in adults with schizophrenia-spectrum disorders.","['Eligible patients', '359 patients for eligibility', '144 patients (mean baseline PANSS total estimated score 78·4', 'adults with schizophrenia-spectrum disorders', 'three academic centres of psychiatry in Norway, and one in Austria', 'Eligible patients were aged 18 years or older, met ICD-10 criteria for schizophrenia-spectrum disorders (F20-29), and had symptoms of active psychosis', '215 patients were excluded (107 did not meet inclusion criteria, 82 declined to participate, 26 other reasons', 'patients with schizophrenia-spectrum disorders (BeSt InTro']","['olanzapine', 'amisulpride', 'aripiprazole', 'oral amisulpride, aripiprazole, or olanzapine', 'Amisulpride, aripiprazole, and olanzapine', 'aripiprazole or olanzapine']","['weight gain', 'efficacy and safety', 'reduction of the Positive And Negative Syndrome Scale (PANSS) total score', 'PANSS total score reduction', 'serum lipids and prolactin', '26 serious adverse events (SAEs', 'PANSS total scores', 'readmission or protracted hospital admission', 'One death by suicide, one unspecified death, and one life-threatening accident']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0028423', 'cui_str': 'Norway'}, {'cui': 'C0004348', 'cui_str': 'Austria'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C1137110', 'cui_str': 'ICD-10'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C4709308', 'cui_str': '215'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C1136454', 'cui_str': 'Refusal to Participate'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}]","[{'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C0103045', 'cui_str': 'Amisulpride'}, {'cui': 'C0299792', 'cui_str': 'aripiprazole'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0428462', 'cui_str': 'Measurement of serum lipid level'}, {'cui': 'C0033371', 'cui_str': 'Prolactin'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038661', 'cui_str': 'Suicide'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0000924', 'cui_str': 'Accident'}]",359.0,0.250627,"INTERPRETATION


Amisulpride was more efficacious than aripiprazole or olanzapine for reducing the PANSS total scores in adults with schizophrenia-spectrum disorders.","[{'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Johnsen', 'Affiliation': 'Haukeland University Hospital, Bergen, Norway; University of Bergen, Bergen, Norway; The Norwegian Centre for Mental Disorders Research Centre of Excellence, Bergen, Norway. Electronic address: erik.johnsen@helse-bergen.no.'}, {'ForeName': 'Rune A', 'Initials': 'RA', 'LastName': 'Kroken', 'Affiliation': 'Haukeland University Hospital, Bergen, Norway; University of Bergen, Bergen, Norway; The Norwegian Centre for Mental Disorders Research Centre of Excellence, Bergen, Norway.'}, {'ForeName': 'Else-Marie', 'Initials': 'EM', 'LastName': 'Løberg', 'Affiliation': 'Haukeland University Hospital, Bergen, Norway; University of Bergen, Bergen, Norway; The Norwegian Centre for Mental Disorders Research Centre of Excellence, Bergen, Norway.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Rettenbacher', 'Affiliation': 'Medizinische Universität Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Joa', 'Affiliation': 'Stavanger University Hospital, Stavanger, Norway.'}, {'ForeName': 'Tor Ketil', 'Initials': 'TK', 'LastName': 'Larsen', 'Affiliation': 'Stavanger University Hospital, Stavanger, Norway; University of Bergen, Bergen, Norway.'}, {'ForeName': 'Solveig Klæbo', 'Initials': 'SK', 'LastName': 'Reitan', 'Affiliation': ""St Olav's University Hospital, Trondheim, Norway; Norges teknisk-naturvitenskapelige universitet, Trondheim, Norway.""}, {'ForeName': 'Berit', 'Initials': 'B', 'LastName': 'Walla', 'Affiliation': ""St Olav's University Hospital, Trondheim, Norway.""}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Alisauskiene', 'Affiliation': 'Haukeland University Hospital, Bergen, Norway; University of Bergen, Bergen, Norway.'}, {'ForeName': 'Liss Gøril', 'Initials': 'LG', 'LastName': 'Anda', 'Affiliation': 'Stavanger University Hospital, Stavanger, Norway.'}, {'ForeName': 'Christoffer', 'Initials': 'C', 'LastName': 'Bartz-Johannessen', 'Affiliation': 'Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Jan Øystein', 'Initials': 'JØ', 'LastName': 'Berle', 'Affiliation': 'Haukeland University Hospital, Bergen, Norway; University of Bergen, Bergen, Norway; The Norwegian Centre for Mental Disorders Research Centre of Excellence, Bergen, Norway.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Bjarke', 'Affiliation': 'Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Farivar', 'Initials': 'F', 'LastName': 'Fathian', 'Affiliation': 'Norske Kvinners Sanitetsforening Olaviken Gerontopsychiatric Hospital, Erdal, Norway; The Norwegian Centre for Mental Disorders Research Centre of Excellence, Bergen, Norway.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Hugdahl', 'Affiliation': 'Haukeland University Hospital, Bergen, Norway; University of Bergen, Bergen, Norway.'}, {'ForeName': 'Eirik', 'Initials': 'E', 'LastName': 'Kjelby', 'Affiliation': 'Haukeland University Hospital, Bergen, Norway; University of Bergen, Bergen, Norway; The Norwegian Centre for Mental Disorders Research Centre of Excellence, Bergen, Norway.'}, {'ForeName': 'Igne', 'Initials': 'I', 'LastName': 'Sinkeviciute', 'Affiliation': 'Haukeland University Hospital, Bergen, Norway; University of Bergen, Bergen, Norway; The Norwegian Centre for Mental Disorders Research Centre of Excellence, Bergen, Norway.'}, {'ForeName': 'Silje', 'Initials': 'S', 'LastName': 'Skrede', 'Affiliation': 'Haukeland University Hospital, Bergen, Norway; University of Bergen, Bergen, Norway.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Stabell', 'Affiliation': 'Haukeland University Hospital, Bergen, Norway; University of Bergen, Bergen, Norway; The Norwegian Centre for Mental Disorders Research Centre of Excellence, Bergen, Norway.'}, {'ForeName': 'Vidar M', 'Initials': 'VM', 'LastName': 'Steen', 'Affiliation': 'Haukeland University Hospital, Bergen, Norway; University of Bergen, Bergen, Norway; The Norwegian Centre for Mental Disorders Research Centre of Excellence, Bergen, Norway.'}, {'ForeName': 'W Wolfgang', 'Initials': 'WW', 'LastName': 'Fleischhacker', 'Affiliation': 'Medizinische Universität Innsbruck, Innsbruck, Austria.'}]",The lancet. Psychiatry,['10.1016/S2215-0366(20)30341-2']
1410,33069319,Brain-based mediation of non-conscious reduction of phobic avoidance in young women during functional MRI: a randomised controlled experiment.,"BACKGROUND


Exposure therapy is the treatment of choice for anxiety disorders but requires people to confront feared situations and can be distressing. We tested the hypothesis that exposure without conscious awareness would reduce fear in participants with specific phobia by harnessing the neural circuitry supporting the automatic extinction of fear.
METHODS


In this single-centre, randomised controlled experiment, we recruited women aged 18-29 years from an ethnically diverse, community-based population in northeastern USA, between Sept 1, 2013, and Aug 1, 2016. Eligible participants classified as having phobia met the DSM-5 criteria for specific phobia but not for any other disorder, had scores in the top 10% of respondents to the Fear of Spiders Questionnaire, and exhibited impairing avoidance of a live tarantula. Eligible controls met no criteria for any disorder, were in the bottom 30% of questionnaire respondents, and displayed no avoidance of the tarantula. The randomisation schedule was generated with the open source Research Randomizer Tool. A research assistant randomly assigned participants to the active intervention of very brief exposure (VBE)-the repeated presentation of masked phobic stimuli (ie, spiders)-or the control intervention which used masked flowers (VBF). VBE and VBF were given code numbers to prevent staff from knowing which intervention they were administering. During a 10 min functional MRI (fMRI) task, each participant was exposed to 16 blocks of ten masked target stimuli (spiders or flowers), alternating with 16 blocks of ten masked neutral stimuli. A few minutes after fMRI, participants with spider phobia approached the tarantula again so we could measure changes in phobic behaviour. The primary outcome was real-time changes in brain activity measured by fMRI. All analyses were done by intention to treat.
RESULTS


We recruited 82 women, of whom 42 had spider phobia and 40 were controls. VBE generated stronger neural activity in participants with spider phobia than in controls, particularly in regions supporting emotion, emotion regulation, and attention systems, such as the inferior frontal cortex (Cohen's d 0·95, 95% CI 0·93-0·98, Bayesian posterior probability 99·5%) and the caudate nucleus (1·16, 1·14-1·18, 100·0%). In participants with phobia, VBE also generated stronger activity in these regions than did VBF (eg, dorsal anterior cingulate cortex Cohen's d 0·80, 95% CI 0·78-0·80, Bayesian posterior probability 98·5%; caudate nucleus 1·0, 0·98-1·02, 99·5%). VBE reduced avoidance of the live tarantula in participants with phobia. Regions supporting fear extinction (including ventral medial prefrontal cortex) and emotional salience processing mediated this effect. No adverse events occurred.
INTERPRETATION


VBE reduced fear non-consciously in participants with spider phobia by recruiting brain regions supporting automatic fear extinction, emotion regulation, and top-down attentional processing. Future studies should explore the use of VBE in other fear-based disorders.
FUNDING


National Institutes of Mental Health and Brain & Behavior Research Foundation.",2020,"VBE generated stronger neural activity in participants with spider phobia than in controls, particularly in regions supporting emotion, emotion regulation, and attention systems, such as the inferior frontal cortex (Cohen's d 0·95, 95% CI 0·93-0·98, Bayesian posterior probability 99·5%) and the caudate nucleus (1·16, 1·14-1·18, 100·0%).","['young women during functional MRI', 'Eligible participants classified as having phobia met the DSM-5 criteria for specific phobia but not for any other disorder, had scores in the top 10% of respondents to the Fear of Spiders Questionnaire, and exhibited impairing avoidance of a live tarantula', 'participants with spider phobia', 'participants with phobia', '82 women, of whom 42 had spider phobia and 40 were controls', 'recruited women aged 18-29 years from an ethnically diverse, community-based population in northeastern USA, between Sept 1, 2013, and Aug 1, 2016', 'participants with specific phobia by harnessing the neural circuitry supporting the automatic extinction of fear']","['VBE', 'active intervention of very brief exposure (VBE)-the repeated presentation of masked phobic stimuli (ie, spiders)-or the control intervention which used masked flowers (VBF', 'Brain-based mediation of non-conscious reduction']","['phobic avoidance', 'real-time changes in brain activity measured by fMRI', 'neural activity', 'adverse events', 'VBE reduced avoidance of the live tarantula', 'phobic behaviour']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0349231', 'cui_str': 'Phobia'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0236801', 'cui_str': 'Simple phobia'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0392331', 'cui_str': 'Arachnophobia'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0015272', 'cui_str': 'Exhibits as Topic'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C3873748', 'cui_str': 'Harness'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0015347', 'cui_str': 'Psychological Extinction'}, {'cui': 'C0015726', 'cui_str': 'Fear'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0037913', 'cui_str': 'Order Araneae'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0330090', 'cui_str': 'Flowers'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0680727', 'cui_str': 'Mediation'}, {'cui': 'C0234421', 'cui_str': 'Consciousness'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]","[{'cui': 'C0564500', 'cui_str': 'Phobic avoidance - mental defense mechanism'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0443158', 'cui_str': 'Brain activity'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",82.0,0.222815,"VBE generated stronger neural activity in participants with spider phobia than in controls, particularly in regions supporting emotion, emotion regulation, and attention systems, such as the inferior frontal cortex (Cohen's d 0·95, 95% CI 0·93-0·98, Bayesian posterior probability 99·5%) and the caudate nucleus (1·16, 1·14-1·18, 100·0%).","[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Siegel', 'Affiliation': 'School of Natural and Social Sciences, Purchase College, State University of New York (SUNY), Purchase, NY, USA. Electronic address: paul.siegel@purchase.edu.'}, {'ForeName': 'Zhishun', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'New York State Psychiatric Institute, Columbia University, New York, NY, USA.'}, {'ForeName': 'Lilly', 'Initials': 'L', 'LastName': 'Murray', 'Affiliation': 'School of Natural and Social Sciences, Purchase College, State University of New York (SUNY), Purchase, NY, USA.'}, {'ForeName': 'Julianna', 'Initials': 'J', 'LastName': 'Campos', 'Affiliation': 'School of Natural and Social Sciences, Purchase College, State University of New York (SUNY), Purchase, NY, USA.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Sims', 'Affiliation': 'School of Natural and Social Sciences, Purchase College, State University of New York (SUNY), Purchase, NY, USA.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Leighton', 'Affiliation': 'School of Natural and Social Sciences, Purchase College, State University of New York (SUNY), Purchase, NY, USA.'}, {'ForeName': 'Bradley S', 'Initials': 'BS', 'LastName': 'Peterson', 'Affiliation': ""Institute for the Developing Mind, Children's Hospital Los Angeles, Los Angeles, CA, USA; Department of Psychiatry, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.""}]",The lancet. Psychiatry,['10.1016/S2215-0366(20)30285-6']
1411,33069511,Lower nocturnal blood glucose response to a potato-based mixed evening meal compared to rice in individuals with type 2 diabetes.,"BACKGROUND & AIMS


Guidelines for reducing postprandial blood glucose concentrations include avoiding high glycemic index (GI) foods, such as white potatoes. However, GI testing is often undertaken in the morning with foods consumed in isolation by non-clinical cohorts. We investigated the impact of potato preparation and consumption as part of a mixed-evening meal on postprandial and nocturnal glycemic responses, and postprandial insulin response, in individuals with Type 2 Diabetes Mellitus (T2DM).
METHODS


In a randomized, cross-over design, 24 males and females (age 58.3 ± 9.3 y; BMI: 31.7 ± 6.8 kg/m 2 ) with T2DM (diet or metformin controlled) completed four experimental trials after consuming a standardized breakfast (25% daily energy intake (EI)) and lunch (35% EI). Dinner (40% EI) was consumed at 1800 h being either: 1) boiled potato (BOIL); 2) roasted potato (ROAST); 3) boiled potato cooled for 24 h (COOLED); or 4) basmati rice (CONTROL). Each meal contained 50% carbohydrate, 30% fat and 20% protein. Blood samples were collected prior to, immediately post meal and at 30-min intervals for a further 120 min. A continuous glucose monitor was worn to assess nocturnal interstitial glucose concentrations.
RESULTS


No differences were detected in postprandial venous glucose area under the curve (iAUC) between CONTROL and all three potato conditions. Postprandial insulin iAUC was greater following COOLED compared to CONTROL (P = 0.003; 95% CI: 18.9-111.72 miU/mL). No significant differences between CONTROL and BOIL or ROAST were detected for postprandial insulin concentrations. All potato meals resulted in lower nocturnal glucose AUC than CONTROL (P < 0.001; 95% CI 4.15-15.67 mmol/L x h).
CONCLUSION


Compared to an isoenergetic rice meal, boiled, roasted or boiled then cooled potato-based meals were not associated with unfavourable postprandial glucose responses or nocturnal glycemic control, and can be considered suitable for individuals with T2DM when consumed as part of a mixed-evening meal.
CLINICAL TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry https://www.anzctr.org.au/, ACTRN 12618000480280.",2020,No differences were detected in postprandial venous glucose area under the curve (iAUC) between CONTROL and all three potato conditions.,"['24 males and females (age 58.3\xa0±\xa09.3\xa0y; BMI: 31.7\xa0±\xa06.8\xa0kg/m 2 ) with', 'individuals with type 2 diabetes', 'individuals with Type 2 Diabetes Mellitus (T2DM']","['boiled potato (BOIL); 2) roasted potato (ROAST); 3) boiled potato cooled for 24\xa0h (COOLED); or 4) basmati rice', 'potato-based mixed evening meal', 'T2DM (diet or metformin', 'isoenergetic rice meal, boiled, roasted or boiled then cooled potato-based meals']","['Postprandial insulin iAUC', 'postprandial insulin concentrations', 'nocturnal blood glucose response', 'BOIL or ROAST', 'nocturnal glucose AUC', 'postprandial and nocturnal glycemic responses, and postprandial insulin response', 'nocturnal interstitial glucose concentrations', 'postprandial venous glucose area under the curve (iAUC']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4708784', 'cui_str': '31.7'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]","[{'cui': 'C0453152', 'cui_str': 'Boiled potato'}, {'cui': 'C0453170', 'cui_str': 'Roast potato'}, {'cui': 'C0035567', 'cui_str': 'Rice'}, {'cui': 'C0032846', 'cui_str': 'Potato'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0585040', 'cui_str': 'Evening meal'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0242301', 'cui_str': 'Furuncle'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0242301', 'cui_str': 'Furuncle'}, {'cui': 'C1522203', 'cui_str': 'Interstitial route'}, {'cui': 'C0427743', 'cui_str': 'Glucose concentration, test strip measurement'}]",24.0,0.0221104,No differences were detected in postprandial venous glucose area under the curve (iAUC) between CONTROL and all three potato conditions.,"[{'ForeName': 'Brooke L', 'Initials': 'BL', 'LastName': 'Devlin', 'Affiliation': 'Exercise and Nutrition Research Program, Mary MacKillop Institute for Health Research, Australian Catholic University, Melbourne, 3000, Australia; Department of Dietetics, Nutrition and Sport, La Trobe University, Melbourne, Australia. Electronic address: b.devlin@latrobe.edu.au.'}, {'ForeName': 'Evelyn B', 'Initials': 'EB', 'LastName': 'Parr', 'Affiliation': 'Exercise and Nutrition Research Program, Mary MacKillop Institute for Health Research, Australian Catholic University, Melbourne, 3000, Australia.'}, {'ForeName': 'Bridget E', 'Initials': 'BE', 'LastName': 'Radford', 'Affiliation': 'Exercise and Nutrition Research Program, Mary MacKillop Institute for Health Research, Australian Catholic University, Melbourne, 3000, Australia.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Hawley', 'Affiliation': 'Exercise and Nutrition Research Program, Mary MacKillop Institute for Health Research, Australian Catholic University, Melbourne, 3000, Australia.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2020.09.049']
1412,33069563,Weight-for-height Z-score improves in half of undernourished children hospitalized in surgical wards.,"BACKGROUND


Overall, 10-15% of hospitalized children are undernourished. The present study focuses on pediatric surgical wards. We assessed the impact of undernutrition upon admission on the weight-for-height Z-score (Z-WFH) during hospitalization for surgery. Secondary aims were to investigate the influence of associated factors and to report on the use of nutritional support.
METHODS


All children hospitalized for a surgical procedure between July 2015 and March 2016 were included in this monocentric, prospective study. Children were divided into two groups: whether the Z-WFH upon admission was below -2 standard deviations (undernourished) or not (not undernourished).
RESULTS


A total of 161 of 278 eligible children were included; 27 were undernourished (17%). The change in Z-WFH during hospitalization was greater in undernourished children (0.31±0.11 vs. -0.05±0.05, P=0.005). Of undernourished children, 49% recovered a Z-WFH above -2 SD during hospitalization. There was no difference between undernourished children and not undernourished children regarding age, length of hospital stay, pre- and post-operative duration of nil per os, duration of surgical procedure, ASA score, emergency level of the surgical procedure, and enteral/parenteral nutrition.
CONCLUSION


Our data suggest that the Z-WFH of undernourished children upon admission improved during hospitalization.",2020,"There was no difference between undernourished children and not undernourished children regarding age, length of hospital stay, pre- and post-operative duration of nil per os, duration of surgical procedure, ASA score, emergency level of the surgical procedure, and enteral/parenteral nutrition.
","['A total of 161 of 278 eligible children were included; 27 were undernourished (17', 'undernourished children hospitalized in surgical wards', 'All children hospitalized for a surgical procedure between July 2015 and March 2016', 'pediatric surgical wards']",['Z-WFH'],"['change in Z-WFH during hospitalization', 'length of hospital stay, pre- and post-operative duration of nil per os, duration of surgical procedure, ASA score, emergency level of the surgical procedure, and enteral/parenteral nutrition']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0008098', 'cui_str': 'Children, Hospitalized'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}]",[],"[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0419179', 'cui_str': 'Nil by mouth'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1304890', 'cui_str': 'Enteral'}, {'cui': 'C0030547', 'cui_str': 'Parenteral nutrition'}]",278.0,0.025511,"There was no difference between undernourished children and not undernourished children regarding age, length of hospital stay, pre- and post-operative duration of nil per os, duration of surgical procedure, ASA score, emergency level of the surgical procedure, and enteral/parenteral nutrition.
","[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Wallon', 'Affiliation': 'Unité mobile de nutrition, CHRU de Tours, 2, boulevard Tonnellé, 37044 Tours cedex 9, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Binet', 'Affiliation': 'Service de chirurgie viscérale, urologique, plastique et brûlés, CHRU de Tours, 49, boulevard Béranger, 37044 Tours cedex 9, France.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Bernardo', 'Affiliation': 'Unité mobile de nutrition, CHRU de Tours, 2, boulevard Tonnellé, 37044 Tours cedex 9, France; UMR 1069 «\xa0Nutrition Croissance et Cancer\xa0», Inserm, université de Tours, 10, boulevard Tonnellé, 37000 Tours, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Le Touze', 'Affiliation': 'Service de chirurgie viscérale, urologique, plastique et brûlés, CHRU de Tours, 49, boulevard Béranger, 37044 Tours cedex 9, France.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Lesage', 'Affiliation': 'Service anesthésie-réanimation 1, CHRU de Tours, 2, boulevard Tonnellé, 37044 Tours cedex 9, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Laffon', 'Affiliation': 'Service anesthésie-réanimation 1, CHRU de Tours, 2, boulevard Tonnellé, 37044 Tours cedex 9, France; Université de Tours, 37044 Tours, France.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Lardy', 'Affiliation': 'Service de chirurgie viscérale, urologique, plastique et brûlés, CHRU de Tours, 49, boulevard Béranger, 37044 Tours cedex 9, France; HUGOPEREN, PEDSTART, Inserm, F-CRIN, 2, boulevard Tonnellé, 37044 Tours cedex 9, France; Université de Tours, 37044 Tours, France.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Hankard', 'Affiliation': 'Unité mobile de nutrition, CHRU de Tours, 2, boulevard Tonnellé, 37044 Tours cedex 9, France; UMR 1069 «\xa0Nutrition Croissance et Cancer\xa0», Inserm, université de Tours, 10, boulevard Tonnellé, 37000 Tours, France; HUGOPEREN, PEDSTART, Inserm, F-CRIN, 2, boulevard Tonnellé, 37044 Tours cedex 9, France; Université de Tours, 37044 Tours, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'De Luca', 'Affiliation': 'Unité mobile de nutrition, CHRU de Tours, 2, boulevard Tonnellé, 37044 Tours cedex 9, France; UMR 1069 «\xa0Nutrition Croissance et Cancer\xa0», Inserm, université de Tours, 10, boulevard Tonnellé, 37000 Tours, France. Electronic address: arnaud.deluca@univ-tours.fr.'}]",Archives de pediatrie : organe officiel de la Societe francaise de pediatrie,['10.1016/j.arcped.2020.09.008']
1413,33069584,"Treatment with benfotiamine in patients with diabetic sensorimotor polyneuropathy: A double-blind, randomized, placebo-controlled, parallel group pilot study over 12 months.",,2020,,['patients with diabetic sensorimotor polyneuropathy'],"['benfotiamine', 'placebo']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0271682', 'cui_str': 'Mixed sensory-motor polyneuropathy'}]","[{'cui': 'C0053116', 'cui_str': 'benphothiamine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.552718,,"[{'ForeName': 'Ovidiu Alin', 'Initials': 'OA', 'LastName': 'Stirban', 'Affiliation': 'Internistische Fachklinik Dr. Steger, Nürnberg, Germany. Electronic address: stirban@web.de.'}, {'ForeName': 'Helga', 'Initials': 'H', 'LastName': 'Zeller-Stefan', 'Affiliation': 'Diabetes Zentrum, Essen, Germany.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Schumacher', 'Affiliation': 'Diabetes Zentrum, Essen, Germany.'}, {'ForeName': 'Wilhelm', 'Initials': 'W', 'LastName': 'Gaus', 'Affiliation': 'Institute for Epidemiology and Medical Biometry, University of Ulm, Germany.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Ziegler', 'Affiliation': 'Institute for Clinical Diabetology, German Diabetes Center (DDZ), Leibniz Center for Diabetes Research at Heinrich Heine University, Division of Endocrinology and Diabetology, Medical Faculty, Heinrich Heine University, Düsseldorf, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Schuerholz', 'Affiliation': 'Wörwag Pharma GmbH & Co. KG, Böblingen, Germany; InnoDiab Forschung GmbH, Essen, Germany.'}, {'ForeName': 'Rodica', 'Initials': 'R', 'LastName': 'Pop-Busui', 'Affiliation': 'Department of Internal Medicine, Division of Metabolism, Endocrinology and Diabetes, University of Michigan, USA.'}]",Journal of diabetes and its complications,['10.1016/j.jdiacomp.2020.107757']
1414,33069589,Effect of warming and infusion of red blood cell concentrates on markers of haemolysis: An ex vivo simulation study.,"BACKGROUND


Transfusion of red blood cell (RBC) concentrates is a common procedure to restore blood volume and tissue oxygen delivery in patients with trauma. Although RBC warmers may prevent hypothermia, some warming or infusion equipment may lead to haemolysis and patient injury.
OBJECTIVES


The aim of this study was to test the effect of (i) RBC warming and (ii) administration via manual vs. pump infusion on haemolysis.
METHODS


This experimental ex vivo study studied haemolysis markers of RBC injury. The sample consisted of 90 RBC infusions in two simulations, randomly, 45 warmed RBC infusions and 45 nonwarmed RBC infusions, in two or three stages: before the intervention (baseline-warming, N= 45; nonwarming, N= 45), after water bath warming at 42 °C (warmed, N= 45), and then after the warmed or nonwarmed RBCs were infused by manual or pump infusion at a rate of 100 mL/h (infusion-warming, N= 45; nonwarming, N= 45).
RESULTS


Warmed RBCs showed significantly lower total haemoglobin (Hb) and haematocrit levels and increase in free Hb levels, haemolysis levels, and lactate dehydrogenase (LDH) activity (all p<0.05) than baseline RBCs. Pump infusion RBCs were associated with reduced total Hb and increased free Hb, haemolysis, and potassium (K) levels (all p<0.05) compared with warmed RBCs. In contrast, manual infusion of warmed RBCs resulted in significantly reduced total Hb levels and increased LDH activity (both <0.05). After infusion, total Hb, free Hb, haematocrit, haemolysis, and LDH values were significantly different for warmed vs. nonwarmed RBCs (p<0.05).
CONCLUSIONS


Haemolysis biomarkers increase with RBC warming and infusion, especially when using infusion pumps. Critically ill patients should be carefully monitored for possible complications during and after RBC infusion.",2020,"Pump infusion RBCs were associated with reduced total Hb and increased free Hb, haemolysis, and potassium (K) levels (all p<0.05) compared with warmed RBCs.","['patients with trauma', 'Critically ill patients']","['warming and infusion of red blood cell concentrates', 'RBC warming\xa0and (ii) administration via manual vs. pump infusion', 'i']","['total haemoglobin (Hb) and haematocrit levels and increase\xa0in free Hb levels, haemolysis levels, and lactate dehydrogenase (LDH) activity', 'total Hb, free Hb, haematocrit, haemolysis, and LDH values', 'reduced total Hb and increased free Hb, haemolysis, and potassium (K) levels', 'total Hb levels and increased LDH activity', 'markers of haemolysis']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}]","[{'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0182537', 'cui_str': 'Pump'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0369320', 'cui_str': 'Hemoglobin, free measurement'}, {'cui': 'C0019054', 'cui_str': 'Haemolysis'}, {'cui': 'C0022917', 'cui_str': 'Lactate dehydrogenase'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0202194', 'cui_str': 'Potassium measurement'}, {'cui': 'C0151754', 'cui_str': '[D]Lactic acid dehydrogenase raised'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",,0.0361675,"Pump infusion RBCs were associated with reduced total Hb and increased free Hb, haemolysis, and potassium (K) levels (all p<0.05) compared with warmed RBCs.","[{'ForeName': 'Maria Paula Oliveira', 'Initials': 'MPO', 'LastName': 'Pires', 'Affiliation': 'Safety, Technology and Care Research Group, Department of Paediatric Nursing, Universidade Federal de São Paulo (Federal University of Sao Paulo), R. Napoleão de Barros, 754 - Vila Clementino, Sao Paulo, SP, 04024-002, Brazil; Alliance for Vascular Access Teaching and Research Group, School of Nursing and Midwifery, Menzies Health Institute Queensland, Griffith University, 170 Kessels Road Nathan, Qld, 4111, Brisbane, Queensland, Australia; Paulista University, Health Sciences Institution, R. Vergueiro, 1211 - Aclimação, Sao Paulo, SP, 01533-000, Brazil. Electronic address: mp.pires2@gmail.com.'}, {'ForeName': 'Maria Angélica Sorgini', 'Initials': 'MAS', 'LastName': 'Peterlini', 'Affiliation': 'Safety, Technology and Care Research Group, Department of Paediatric Nursing, Universidade Federal de São Paulo (Federal University of Sao Paulo), R. Napoleão de Barros, 754 - Vila Clementino, Sao Paulo, SP, 04024-002, Brazil. Electronic address: maria.angelica@unifesp.br.'}, {'ForeName': 'Amanda J', 'Initials': 'AJ', 'LastName': 'Ullman', 'Affiliation': 'Alliance for Vascular Access Teaching and Research Group, School of Nursing and Midwifery, Menzies Health Institute Queensland, Griffith University, 170 Kessels Road Nathan, Qld, 4111, Brisbane, Queensland, Australia. Electronic address: a.ullman@griffith.edu.au.'}, {'ForeName': 'Andrew C', 'Initials': 'AC', 'LastName': 'Bulmer', 'Affiliation': 'Alliance for Vascular Access Teaching and Research Group, School of Medical Science, Menzies Health Institute Queensland, Griffith University, Parklands Dr Southport, Qld, 4215, Gold Coast, Queensland, Australia. Electronic address: a.bulmer@griffith.edu.au.'}, {'ForeName': 'Claire M', 'Initials': 'CM', 'LastName': 'Rickard', 'Affiliation': 'Alliance for Vascular Access Teaching and Research Group, School of Nursing and Midwifery, Menzies Health Institute Queensland, Griffith University, 170 Kessels Road Nathan, Qld, 4111, Brisbane, Queensland, Australia. Electronic address: c.rickard@griffith.edu.au.'}, {'ForeName': 'Mavilde Luz Gonçalves', 'Initials': 'MLG', 'LastName': 'Pedreira', 'Affiliation': 'Safety, Technology and Care Research Group, Department of Paediatric Nursing, Universidade Federal de São Paulo (Federal University of Sao Paulo), R. Napoleão de Barros, 754 - Vila Clementino, Sao Paulo, SP, 04024-002, Brazil; Alliance for Vascular Access Teaching and Research Group, School of Nursing and Midwifery, Menzies Health Institute Queensland, Griffith University, 170 Kessels Road Nathan, Qld, 4111, Brisbane, Queensland, Australia. Electronic address: mpedreira@unifesp.br.'}]",Australian critical care : official journal of the Confederation of Australian Critical Care Nurses,['10.1016/j.aucc.2020.08.003']
1415,33069606,A consumer co-created infographic improves short-term knowledge about physical activity and self-efficacy to exercise in women with gestational diabetes mellitus: a randomised trial.,"QUESTION


In women with gestational diabetes mellitus, does the addition of a consumer co-created infographic to usual education about gestational diabetes mellitus improve knowledge about physical activity and self-efficacy to exercise?
DESIGN


A randomised trial with concealed allocation, a blinded assessor and intention-to-treat analysis.
PARTICIPANTS


Sixty-nine women diagnosed with gestational diabetes mellitus.
INTERVENTION


In addition to gestational diabetes education, the experimental group received a paper copy of a consumer co-created infographic about physical activity during a gestational diabetes pregnancy. The control group received gestational diabetes education alone.
OUTCOME MEASURES


Participants completed outcome measures at baseline and again 1 week later. Knowledge of physical activity in a gestational diabetes mellitus pregnancy was assessed using a 19-item questionnaire modified to reflect current physical activity guidelines, with a total score from 0% (worst) to 100% (best). Self-efficacy was measured using the nine-item Self-Efficacy for Exercise Scale, with a total score from 0 (not confident) to 10 (very confident).
RESULTS


Provision of the infographic led to a clinically important between-group difference in knowledge (MD 12%, 95% CI 10 to 15) and self-efficacy (MD 2.5 units, 95% CI 1.9 to 3.0).
CONCLUSION


In women with gestational diabetes mellitus, short-term knowledge about physical activity and self-efficacy to exercise were improved when usual education was supplemented with a consumer co-created infographic that provided specific and relevant information about physical activity during a gestational diabetes mellitus pregnancy.
TRIAL REGISTRATION


ACTRN12619001207101.",2020,"In women with gestational diabetes mellitus, short-term knowledge about physical activity and self-efficacy to exercise were improved when usual education was supplemented with a consumer co-created infographic that provided specific and relevant information about physical activity during a gestational diabetes mellitus pregnancy.
","['women with gestational diabetes mellitus', 'Sixty-nine women diagnosed with gestational diabetes mellitus']","['gestational diabetes education alone', 'paper copy of a consumer co-created infographic about physical activity']","['Self-efficacy', 'self-efficacy']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0450388', 'cui_str': '69'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",69.0,0.135428,"In women with gestational diabetes mellitus, short-term knowledge about physical activity and self-efficacy to exercise were improved when usual education was supplemented with a consumer co-created infographic that provided specific and relevant information about physical activity during a gestational diabetes mellitus pregnancy.
","[{'ForeName': 'Anne L', 'Initials': 'AL', 'LastName': 'Harrison', 'Affiliation': 'Department of Physiotherapy, Podiatry and Prosthetics and Orthotics, La Trobe University, Melbourne, Australia; Physiotherapy Department, Werribee Mercy Hospital, Melbourne, Australia. Electronic address: AHarrison@mercy.com.au.'}, {'ForeName': 'Nicholas F', 'Initials': 'NF', 'LastName': 'Taylor', 'Affiliation': 'Department of Physiotherapy, Podiatry and Prosthetics and Orthotics, La Trobe University, Melbourne, Australia; Allied Health Clinical Research Office, Eastern Health, Melbourne, Australia.'}, {'ForeName': 'Helena C', 'Initials': 'HC', 'LastName': 'Frawley', 'Affiliation': 'School of Primary and Allied Health Care, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia.'}, {'ForeName': 'Nora', 'Initials': 'N', 'LastName': 'Shields', 'Affiliation': 'Department of Physiotherapy, Podiatry and Prosthetics and Orthotics, La Trobe University, Melbourne, Australia.'}]",Journal of physiotherapy,['10.1016/j.jphys.2020.09.010']
1416,33069608,"Feedback-guided exercises performed on a tablet touchscreen improve return to work, function, strength and healthcare usage more than an exercise program prescribed on paper for people with wrist, hand or finger injuries: a randomised trial.","QUESTION


In people with bone and soft tissue injuries of the wrist, hand and/or fingers, do feedback-guided exercises performed on a tablet touchscreen hasten return to work, reduce healthcare usage and improve clinical recovery more than a home exercise program prescribed on paper?
DESIGN


Randomised, parallel-group trial with concealed allocation, assessor blinding and intention-to-treat analysis.
PARTICIPANTS


Seventy-four workers with limited functional ability due to bone and soft tissue injuries of the wrist, hand and/or fingers.
INTERVENTION


Participants in the experimental and control groups received the same in-patient physiotherapy and occupational therapy. Participants in the experimental group received a home exercise program using the ReHand tablet application, which guides exercises performed on a tablet touchscreen with feedback, monitoring and progression. Participants in the control group were prescribed an evidence-based home exercise program on paper.
OUTCOME MEASURES


The primary outcome was the time taken to return to work. Secondary outcomes included: healthcare usage (number of clinical appointments); and functional ability, pain intensity, and grip and pinch strength 2 and 4 weeks after randomisation.
RESULTS


Compared with the control group, the experimental group: returned to work sooner (MD -18 days, 95% CI -33 to -3); required fewer physiotherapy sessions (MD -7.4, 95% CI -13.1 to -1.6), rehabilitation consultations (MD -1.9, 95% CI -3.6 to 0.3) and plastic surgery consultations (MD -3.6, 95% CI -6.3 to -0.9); and had better short-term recovery of functional ability and pinch strength.
CONCLUSION


In people with bone and soft-tissue injuries of the wrist, hand and/or fingers, prescribing a feedback-guided home exercise program using a tablet-based application instead of a conventional program on paper hastened return to work and improved the short-term recovery of functional ability and pinch strength, while reducing the number of required healthcare appointments.
TRIAL REGISTRATION


ACTRN12619000344190.",2020,"Compared with the control group, the experimental group: returned to work sooner (MD -18 days, 95% CI -33 to -3); required fewer physiotherapy sessions (MD -7.4, 95% CI -13.1 to -1.6), rehabilitation consultations (MD -1.9, 95% CI -3.6 to 0.3) and plastic surgery consultations (MD -3.6, 95% CI -6.3 to -0.9); and had better short-term recovery of functional ability and pinch strength.
","['people with wrist, hand or finger injuries', 'Seventy-four workers with limited functional ability due to bone and soft tissue injuries of the wrist, hand and/or fingers']","['home exercise program using the ReHand tablet application, which guides exercises performed on a tablet touchscreen with feedback, monitoring and progression', 'Feedback-guided exercises', 'same in-patient physiotherapy and occupational therapy', 'evidence-based home exercise program on paper', 'exercise program']","['rehabilitation consultations', 'healthcare usage (number of clinical appointments); and functional ability, pain intensity, and grip and pinch strength 2 and 4 weeks after randomisation', 'plastic surgery consultations', 'functional ability and pinch strength', 'time taken to return to work']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0016124', 'cui_str': 'Injury of finger'}, {'cui': 'C4517867', 'cui_str': '74'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0037578', 'cui_str': 'Soft tissue injury'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}]","[{'cui': 'C0475647', 'cui_str': 'Home exercise program'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C1318464', 'cui_str': 'Occupational therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0220843', 'cui_str': 'Grasp'}, {'cui': 'C1720876', 'cui_str': 'Pinch Strength'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0038911', 'cui_str': 'Plastic surgery - specialty'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0425105', 'cui_str': 'Returned to work'}]",74.0,0.0831718,"Compared with the control group, the experimental group: returned to work sooner (MD -18 days, 95% CI -33 to -3); required fewer physiotherapy sessions (MD -7.4, 95% CI -13.1 to -1.6), rehabilitation consultations (MD -1.9, 95% CI -3.6 to 0.3) and plastic surgery consultations (MD -3.6, 95% CI -6.3 to -0.9); and had better short-term recovery of functional ability and pinch strength.
","[{'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Blanquero', 'Affiliation': 'Physiotherapy Department, University of Seville, Seville, Spain.'}, {'ForeName': 'María-Dolores', 'Initials': 'MD', 'LastName': 'Cortés-Vega', 'Affiliation': 'Physiotherapy Department, University of Seville, Seville, Spain. Electronic address: mdcortes@us.es.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Rodríguez-Sánchez-Laulhé', 'Affiliation': 'Physiotherapy Department, University of Seville, Seville, Spain.'}, {'ForeName': 'Berta-Pilar', 'Initials': 'BP', 'LastName': 'Corrales-Serra', 'Affiliation': 'Physiotherapy Department, Ibermutua, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Gómez-Patricio', 'Affiliation': 'Occupational Therapy Department, Ibermutua, Spain.'}, {'ForeName': 'Noemi', 'Initials': 'N', 'LastName': 'Díaz-Matas', 'Affiliation': 'Physiotherapy Department, Ibermutua, Spain.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Suero-Pineda', 'Affiliation': 'Physiotherapy Department, University of Seville, Seville, Spain.'}]",Journal of physiotherapy,['10.1016/j.jphys.2020.09.012']
1417,33069623,Longitudinal Evaluation of Perineogenital Pain and Postoperative Complications After One-stage Buccal Mucosal Graft Urethroplasty: A Secondary Analysis of a Randomized Controlled Trial.,"BACKGROUND


Little is known about patient-reported intensity and quality of pain at the receiver site as well as postoperative complications following one-stage buccal mucosal graft urethroplasty (BMGU).
OBJECTIVE


To evaluate perineogenital pain intensity and quality as well as short-term complications after BMGU, and to describe the impact of pain and complications on stricture recurrence.
DESIGN, SETTING, AND PARTICIPANTS


A secondary analysis of a randomized controlled trial including 135 patients, who underwent BMGU from 2014 to 2015, was performed.
INTERVENTION


One-stage BMGU.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS


Patient-reported perineogenital pain was assessed by the Numeric Pain Rating Scale and the Short-form McGill Pain Questionnaire preoperatively and at 1, 5, and 21 d, and 3, 6, and 12 mo postoperatively. Complications were assessed by the Clavien-Dindo classification and the Comprehensive Complication Index. Pain and complications were compared according to stricture recurrence.
RESULTS AND LIMITATIONS


At a mean follow-up of 21±15 mo, 29 patients (21%) had stricture recurrence. Pain intensity as well as sensory and affective pain quality decreased over time, reaching a minimum at 6 mo. Postoperative complications at days 5 (95% of patients) and 21 (27% of patients) were predominantly ""minor"" (Clavien-Dindo classification grade≤IIIa). Neither patient-reported perineogenital pain nor cumulative morbidity burden was different between patients with and those without stricture recurrence (all p ≥ 0.05).
CONCLUSIONS


Perineogenital pain is frequent after BMGU, but pain intensity and quality decrease over time. The same holds true for postoperative complications, which are frequent but mostly present as minor events. Current findings allow for thorough preoperative patient counseling regarding the expected perineogenital pain intensity and quality over time as well as complications following BMGU.
PATIENT SUMMARY


In this study, we looked at pain intensity and pain quality as well as complications following buccal mucosal graft urethroplasty. We found that pain in the perineogenital region is frequent, but pain intensity and quality decrease over time. Similarly, postoperative complications are frequent, but mainly present as minor events.",2020,"Neither patient-reported perineogenital pain nor cumulative morbidity burden was different between patients with and those without stricture recurrence (all p ≥ 0.05).
","['135 patients, who underwent BMGU from 2014 to 2015, was performed', 'After One-stage Buccal Mucosal Graft Urethroplasty']",[],"['Pain intensity as well as sensory and affective pain quality', 'Clavien-Dindo classification and the Comprehensive Complication Index', 'Perineogenital Pain and Postoperative Complications', 'postoperative complications', 'Postoperative complications', 'Complications', 'Pain and complications', 'pain intensity and pain quality', 'perineogenital pain intensity and quality', 'perineogenital pain', 'stricture recurrence', 'perineogenital pain nor cumulative morbidity burden', 'pain intensity and quality decrease over time', 'Numeric Pain Rating Scale and the Short-form McGill Pain Questionnaire']","[{'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C0450135', 'cui_str': 'Mucosal graft'}, {'cui': 'C0161922', 'cui_str': 'Repair of urethra'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]",[],"[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C1261287', 'cui_str': 'Stenosis'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0457972', 'cui_str': 'Short form McGill pain questionnaire'}]",135.0,0.180189,"Neither patient-reported perineogenital pain nor cumulative morbidity burden was different between patients with and those without stricture recurrence (all p ≥ 0.05).
","[{'ForeName': 'Constantin', 'Initials': 'C', 'LastName': 'Fuehner', 'Affiliation': 'Department of Urology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Malte W', 'Initials': 'MW', 'LastName': 'Vetterlein', 'Affiliation': 'Department of Urology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Lesske', 'Affiliation': 'Department of Urology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Rink', 'Affiliation': 'Department of Urology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Silke', 'Initials': 'S', 'LastName': 'Riechardt', 'Affiliation': 'Department of Urology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Frederik', 'Initials': 'F', 'LastName': 'König', 'Affiliation': 'Department of Urology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Gild', 'Affiliation': 'Department of Urology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Hans O', 'Initials': 'HO', 'LastName': 'Pinnschmidt', 'Affiliation': 'Institute of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Christian P', 'Initials': 'CP', 'LastName': 'Meyer', 'Affiliation': 'Department of Urology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Tim A', 'Initials': 'TA', 'LastName': 'Ludwig', 'Affiliation': 'Department of Urology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Engel', 'Affiliation': 'Department of Urology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Margit', 'Initials': 'M', 'LastName': 'Fisch', 'Affiliation': 'Department of Urology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Dahlem', 'Affiliation': 'Department of Urology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Soave', 'Affiliation': 'Department of Urology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany. Electronic address: a.soave@uke.de.'}]",European urology focus,['10.1016/j.euf.2020.09.018']
1418,33069664,Wide awake at bedtime? Effects of caffeine on sleep and circadian timing in male adolescents - a randomized crossover trial.,"Adolescents often suffer from short and mistimed sleep. To counteract the resulting daytime sleepiness they frequently consume caffeine. However, caffeine intake may exaggerate sleep problems by disturbing sleep and circadian timing. In a 28-hour double-blind randomized crossover study, we investigated to what extent caffeine disturbs slow-wave sleep (SWS) and delays circadian timing in teenagers. Following a 6-day ambulatory phase of caffeine abstinence and fixed sleep-wake-cycles, 18 male teenagers (14-17 years old) ingested 80 mg caffeine vs. placebo in the laboratory four hours prior to an electro-encephalographically (EEG) monitored nighttime sleep episode. Data were analyzed using both frequentist and Bayesian statistics. The analyses suggest that subjective sleepiness is reduced after caffeine compared to placebo. However, we did not observe a substantial influence of the given dose neither on subjective sleep quality nor on SWS, but rather a high inter-individual variability in caffeine-induced SWS changes. Exploratory analyses suggest that particularly those individuals with a higher level of SWS during placebo reduced SWS in response to caffeine. Regarding salivary melatonin onsets, caffeine-induced delays were not evident at group level, and only observed in participants exposed to a higher caffeine dose relative to individual bodyweight (i.e., a dose >1.3mg/kg). Together, the results suggest that 80 mg caffeine are sufficient to induce alertness at a subjective level. However, particularly teenagers with a strong need for deep sleep might pay for these subjective benefits by a loss of SWS during the night. Thus, caffeine-induced sleep-disruptions might change along with the maturation of sleep need.",2020,Exploratory analyses suggest that particularly those individuals with a higher level of SWS during placebo reduced SWS in response to caffeine.,"['male adolescents', 'Adolescents often suffer from short and mistimed sleep', '18 male teenagers (14-17 years old', 'teenagers']","['caffeine abstinence and fixed sleep-wake-cycles', 'caffeine', 'ingested 80 mg caffeine vs. placebo', 'caffeine disturbs slow-wave sleep (SWS', 'placebo']","['subjective sleep quality', 'daytime sleepiness', 'sleep and circadian timing', 'subjective sleepiness']","[{'cui': 'C0001589', 'cui_str': 'Adolescents, Male'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0234451', 'cui_str': 'Non-rapid eye movement sleep'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0449243', 'cui_str': 'Timing'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}]",,0.0515205,Exploratory analyses suggest that particularly those individuals with a higher level of SWS during placebo reduced SWS in response to caffeine.,"[{'ForeName': 'Carolin F', 'Initials': 'CF', 'LastName': 'Reichert', 'Affiliation': 'Centre for Chronobiology, Psychiatric Hospital of the University of Basel, Basel, Switzerland; Transfaculty Research Platform Molecular and Cognitive Neurosciences, University of Basel, Basel, Switzerland. Electronic address: carolin.reichert@upk.ch.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Veitz', 'Affiliation': 'Centre for Chronobiology, Psychiatric Hospital of the University of Basel, Basel, Switzerland; Transfaculty Research Platform Molecular and Cognitive Neurosciences, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Bühler', 'Affiliation': 'Centre for Chronobiology, Psychiatric Hospital of the University of Basel, Basel, Switzerland; Transfaculty Research Platform Molecular and Cognitive Neurosciences, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Gruber', 'Affiliation': 'The Siesta Group, Vienna, Austria.'}, {'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Deuring', 'Affiliation': 'Department of Forensic Psychiatry, Psychiatric Hospital of the University of Basel, Basel, Switzerland.'}, {'ForeName': 'Sophia S', 'Initials': 'SS', 'LastName': 'Rehm', 'Affiliation': 'Laboratory Medicine, University Hospital Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Rentsch', 'Affiliation': 'Laboratory Medicine, University Hospital Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Corrado', 'Initials': 'C', 'LastName': 'Garbazza', 'Affiliation': 'Centre for Chronobiology, Psychiatric Hospital of the University of Basel, Basel, Switzerland; Transfaculty Research Platform Molecular and Cognitive Neurosciences, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Meyer', 'Affiliation': 'Clinical Sleep Laboratory, Psychiatric Hospital of the University of Basel, Basel, Switzerland.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Slawik', 'Affiliation': 'Clinical Sleep Laboratory, Psychiatric Hospital of the University of Basel, Basel, Switzerland.'}, {'ForeName': 'Yu-Shiuan', 'Initials': 'YS', 'LastName': 'Lin', 'Affiliation': 'Centre for Chronobiology, Psychiatric Hospital of the University of Basel, Basel, Switzerland; Transfaculty Research Platform Molecular and Cognitive Neurosciences, University of Basel, Basel, Switzerland; Neuropsychiatry and Brain Imaging, Psychiatric Hospital of the University of Basel, Basel, Switzerland.'}, {'ForeName': 'Janine', 'Initials': 'J', 'LastName': 'Weibel', 'Affiliation': 'Centre for Chronobiology, Psychiatric Hospital of the University of Basel, Basel, Switzerland; Transfaculty Research Platform Molecular and Cognitive Neurosciences, University of Basel, Basel, Switzerland.'}]",Biochemical pharmacology,['10.1016/j.bcp.2020.114283']
1419,33069667,The effectiveness of early parental coaching in the autism spectrum disorder.,"OBJECTIVE


Analysis of the effectiveness of early Parental Coaching in the Autism Spectrum Disorder.
METHOD


Randomized, controlled and blinded clinical trial to analyze parent-child interaction videos.
RESULTS


The sample consisted of 18 children being followed up at the Autism Outpatient Clinic of a Neuropediatric Center in southern Brazil diagnosed with Autism Spectrum Disorder, between 29 and 42 months of age, randomly allocated to two groups: the Study Group (SG; n = 9), which received Parental Coaching performed by a professional certified by the ESDM (Early Start Denver Model); and the Control Group (CG; n = 9), which was in a routine follow-up, without treatment and training of parents by a trained professional. The parents of the SG were willing to attend weekly meetings and to apply the instructional techniques at home with their children. It took 12 weeks and an average of 2 h per meeting.
CONCLUSIONS


The learning rate for comprehensive development skills in the ESDM checklist, such as receptive communication, expressive communication, social capacity, imitation, cognition, games, fine motor skills, gross motor skills, behavior, and personal independence was significantly higher in the SG, as well as the strategies and the quality of interaction between parents and children. Thus, Parental Coaching presents as a possibility of early intervention in children with Autism Spectrum Disorder.",2020,"The learning rate for comprehensive development skills in the ESDM checklist, such as receptive communication, expressive communication, social capacity, imitation, cognition, games, fine motor skills, gross motor skills, behavior, and personal independence was significantly higher in the SG, as well as the strategies and the quality of interaction between parents and children.","['children with Autism Spectrum Disorder', '18 children being followed up at the Autism Outpatient Clinic of a Neuropediatric Center in southern Brazil diagnosed with Autism Spectrum Disorder, between 29 and 42 months of age', 'autism spectrum disorder']","['Parental Coaching performed by a professional certified by the ESDM (Early Start Denver Model); and the Control Group (CG; n\u202f=\u202f9), which was in a routine follow-up, without treatment and training of parents by a trained professional', 'early parental coaching', 'early Parental Coaching']","['receptive communication, expressive communication, social capacity, imitation, cognition, games, fine motor skills, gross motor skills, behavior, and personal independence']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0007836', 'cui_str': 'Certification'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}]","[{'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205232', 'cui_str': 'Fine'}, {'cui': 'C0026612', 'cui_str': 'Motor Skills'}, {'cui': 'C0439806', 'cui_str': 'Gross'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",18.0,0.0346392,"The learning rate for comprehensive development skills in the ESDM checklist, such as receptive communication, expressive communication, social capacity, imitation, cognition, games, fine motor skills, gross motor skills, behavior, and personal independence was significantly higher in the SG, as well as the strategies and the quality of interaction between parents and children.","[{'ForeName': 'Edilici R S', 'Initials': 'ERS', 'LastName': 'Malucelli', 'Affiliation': 'Universidade Federal do Paraná, Hospital das Clínicas, Centro de Neurologia Pediátrica (CHC-UFPR), Curitiba, PR, Brazil. Electronic address: edilici@espacocomunicar.com.br.'}, {'ForeName': 'Sérgio Antônio', 'Initials': 'SA', 'LastName': 'Antoniuk', 'Affiliation': 'Universidade Federal do Paraná, Hospital das Clínicas, Centro de Neurologia Pediátrica (CHC-UFPR), Curitiba, PR, Brazil.'}, {'ForeName': 'Nicole Oliveira', 'Initials': 'NO', 'LastName': 'Carvalho', 'Affiliation': 'Universidade Federal de Minas Gerais, Belo Horizonte, MG, Brazil.'}]",Jornal de pediatria,['10.1016/j.jped.2020.09.004']
1420,33069668,A Pilot Randomized Controlled Trial of Early Targeted Patent Ductus Arteriosus Treatment Using a Risk Based Severity Score (The PDA RCT).,"OBJECTIVES


To evaluate the feasibility of recruiting preterm infants to a randomized controlled trial of patent ductus arteriosus (PDA) treatment based on a PDA severity score (PDAsc) and to characterize challenges in obtaining consent, compliance with the protocol, and PDA closure rates.
STUDY DESIGN


This was a single center, randomized control pilot study of 60 infants <29 weeks' gestation with a high PDAsc (≥5.0) at 36-48 hours of age receiving either Ibuprofen or Placebo intravenously. The study protocol did not allow for additional PDA therapy within the first two weeks. We reported the rate of consent, open label treatment and PDA closure rates. The primary outcome was chronic lung disease/Death.
RESULTS


83 families were approached for enrollment with 73 (88%) providing consent; 13 infants had a PDAsc < 5; of the remaining infants, 30 were assigned Ibuprofen and 30 received placebo. Eight infants received open label treatment in the first two weeks (12%). The overall PDA closure rate after treatment was 57% in the Intervention Group and 17% in the Control Group (p<0.01). There was no difference in the primary clinical outcome (odds ratio 0.8, 95% confidence interval 0.3-2.1).
CONCLUSION


Using a PDA severity score for infant recruitment to a PDA treatment RCT is feasible. There is a high rate of consent and relatively low rate of open label PDA treatment. The overall PDA closure rate in the intervention arm was low placing the emphasis on devising more effective PDA closure strategies in future RCTs.
TRIAL REGISTRATION


ISRCTN (13281214) and European Union Drug Regulating Authorities Clinical Trials Database (2015-004526-33).",2020,"There was no difference in the primary clinical outcome (odds ratio 0.8, 95% confidence interval 0.3-2.1).
","['Early Targeted Patent Ductus', 'preterm infants', ""60 infants <29 weeks' gestation with a high PDAsc (≥5.0) at 36-48 hours of age receiving either"", '83 families were approached for enrollment with 73 (88%) providing consent; 13 infants had a PDAsc < 5; of the remaining infants, 30 were assigned']","['patent ductus arteriosus (PDA', 'Ibuprofen', 'Ibuprofen or Placebo intravenously', 'open label treatment', 'placebo', 'Arteriosus Treatment']","['chronic lung disease/Death', 'PDA severity score (PDAsc', 'overall PDA closure rate']","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0030650', 'cui_str': 'Patents'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0013274', 'cui_str': 'Patent ductus arteriosus'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0013274', 'cui_str': 'Patent ductus arteriosus'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0746102', 'cui_str': 'Chronic lung disease'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0013274', 'cui_str': 'Patent ductus arteriosus'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}]",83.0,0.162098,"There was no difference in the primary clinical outcome (odds ratio 0.8, 95% confidence interval 0.3-2.1).
","[{'ForeName': 'Afif', 'Initials': 'A', 'LastName': 'El-Khuffash', 'Affiliation': 'Department of Neonatology, The Rotunda Hospital, Dublin, Ireland; Department of Pediatrics, The Royal College of Surgeons in Ireland, Dublin, Ireland. Electronic address: afifelkhuffash@rcsi.com.'}, {'ForeName': 'Neidín', 'Initials': 'N', 'LastName': 'Bussmann', 'Affiliation': 'Department of Neonatology, The Rotunda Hospital, Dublin, Ireland.'}, {'ForeName': 'Colm R', 'Initials': 'CR', 'LastName': 'Breatnach', 'Affiliation': 'Department of Neonatology, The Rotunda Hospital, Dublin, Ireland.'}, {'ForeName': 'Aisling', 'Initials': 'A', 'LastName': 'Smith', 'Affiliation': 'Department of Neonatology, The Rotunda Hospital, Dublin, Ireland.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Tully', 'Affiliation': 'Department of Obstetrics & Gynecology, The Royal College of Surgeons in Ireland, Dublin, Ireland.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Griffin', 'Affiliation': 'Department of Research & Academic Affairs, The Rotunda Hospital, Dublin, Ireland.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'McCallion', 'Affiliation': 'Department of Neonatology, The Rotunda Hospital, Dublin, Ireland; Department of Pediatrics, The Royal College of Surgeons in Ireland, Dublin, Ireland.'}, {'ForeName': 'John David', 'Initials': 'JD', 'LastName': 'Corcoran', 'Affiliation': 'Department of Neonatology, The Rotunda Hospital, Dublin, Ireland; Department of Pediatrics, The Royal College of Surgeons in Ireland, Dublin, Ireland.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Fernandez', 'Affiliation': 'Department of Pharmacy, The Rotunda Hospital, Dublin, Ireland.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Looi', 'Affiliation': 'Department of Pharmacy, The Rotunda Hospital, Dublin, Ireland.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Cleary', 'Affiliation': 'Department of Pharmacy, The Rotunda Hospital, Dublin, Ireland; School of Pharmacy, Royal College of Surgeons in Ireland.'}, {'ForeName': 'Orla', 'Initials': 'O', 'LastName': 'Franklin', 'Affiliation': ""Department of Pediatric Cardiology, Our Lady's Children's Hospital Crumlin, Ireland.""}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'McNamara', 'Affiliation': ""Division of Neonatology, Stead Family Children's Hospital, Iowa City, IA, USA; Departments of Pediatrics, University of Iowa, IA, USA; Departments of Cardiology, University of Iowa, IA, USA.""}]",The Journal of pediatrics,['10.1016/j.jpeds.2020.10.024']
1421,33069714,Predominant DNMT and TET mediate effects of allergen on the human bronchial epithelium in a controlled air pollution exposure study.,"BACKGROUND


Epidemiological data show that traffic-related air pollution contributes to the increasing prevalence and severity of asthma. DNA methylation (DNAm) changes may elucidate adverse health effects of environmental exposures.
OBJECTIVES


To assess the effects of allergen and diesel exhaust (DE) exposures on global DNAm and its regulation enzymes in human airway epithelium.
METHODS


11 participants, including 7 with and 4 without airway hyperresponsiveness (AHR), were recruited for a randomized, double-blinded crossover study. Each participant had 3 exposures: filtered air + saline (FA-S), filtered air + allergen (FA-A), and DE + allergen (DE-A). 48 hours post-exposure, endobronchial biopsies and bronchoalveolar lavages (BAL) were collected. Levels of DNA methyltransferases (DNMTs) and ten-eleven translocation enzymes (TETs), 5-methylcytosine (5mC), and 5-hydroxymethylcytosine (5hmC) were determined by immunohistochemistry. Cytokines and chemokines in BAL were measured by electrochemiluminescence multiplex assays.
RESULTS


Predominant DNMT (pDNMT, the most abundant among DNMT1, DNMT3A, and DNMT3B), and predominant TET (pTET, the most abundant among TET1, TET2, and TET3) were participant-dependent. 5mC and its regulation enzymes differed between participants with and without AHR at baseline (FA-S) and in response to allergen challenge (regardless of DE exposure). pDNMT and pTET correlated with lung function. Allergen challenge effect on interleukin-8 in BAL was modified by TET2 baseline levels in the epithelium.
CONCLUSIONS


Response to allergen challenge is associated with key DNAm regulation enzymes. This relationship is generally unaltered by DE co-exposure but is rather dependent on AHR status. These enzymes therefore warranted further inquiry regarding their potential in diagnosis, prognosis, and treatment of asthma.",2020,"Levels of DNA methyltransferases (DNMTs) and ten-eleven translocation enzymes (TETs), 5-methylcytosine (5mC), and 5-hydroxymethylcytosine (5hmC) were determined by immunohistochemistry.","['participants with and without AHR at baseline (FA-S', 'human airway epithelium', '11 participants, including 7 with and 4 without airway hyperresponsiveness (AHR']","['allergen and diesel exhaust (DE', 'filtered air + saline (FA-S), filtered air + allergen (FA-A), and DE + allergen (DE-A']","['Levels of DNA methyltransferases (DNMTs) and ten-eleven translocation enzymes (TETs), 5-methylcytosine (5mC), and 5-hydroxymethylcytosine (5hmC', 'Cytokines and chemokines in BAL', 'endobronchial biopsies and bronchoalveolar lavages (BAL']","[{'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0180860', 'cui_str': 'Filter'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0014609', 'cui_str': 'Epithelium'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0002092', 'cui_str': 'Allergen'}, {'cui': 'C0012151', 'cui_str': 'Diesel Exhaust'}, {'cui': 'C0180860', 'cui_str': 'Filter'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic acid'}, {'cui': 'C0040715', 'cui_str': 'Chromosomal translocation'}, {'cui': 'C0014442', 'cui_str': 'Enzyme'}, {'cui': 'C0049308', 'cui_str': '5-Methylcytosine'}, {'cui': 'C0049241', 'cui_str': '5-hydroxymethylcytosine'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0282554', 'cui_str': 'Cytokines, Chemotactic'}, {'cui': 'C1535502', 'cui_str': 'Bronchoalveolar lavage'}, {'cui': 'C0444471', 'cui_str': 'Endobronchial'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}]",11.0,0.101868,"Levels of DNA methyltransferases (DNMTs) and ten-eleven translocation enzymes (TETs), 5-methylcytosine (5mC), and 5-hydroxymethylcytosine (5hmC) were determined by immunohistochemistry.","[{'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Otolaryngology, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China; Air Pollution Exposure Laboratory, Department of Medicine, Division of Respiratory Medicine, The University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Min Hyung', 'Initials': 'MH', 'LastName': 'Ryu', 'Affiliation': 'Air Pollution Exposure Laboratory, Department of Medicine, Division of Respiratory Medicine, The University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Christopher F', 'Initials': 'CF', 'LastName': 'Rider', 'Affiliation': 'Air Pollution Exposure Laboratory, Department of Medicine, Division of Respiratory Medicine, The University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Wayne', 'Initials': 'W', 'LastName': 'Tse', 'Affiliation': 'Air Pollution Exposure Laboratory, Department of Medicine, Division of Respiratory Medicine, The University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'Clifford', 'Affiliation': 'Nottingham NIHR Biomedical Research Centre, Nottingham MRC Molecular Pathology Node, Division of Respiratory Medicine, University of Nottingham, Nottingham University Hospitals NHS Trust, City Hospital, Nottingham, UK.'}, {'ForeName': 'Maria J', 'Initials': 'MJ', 'LastName': 'Aristizabal', 'Affiliation': ""Centre for Molecular Medicine and Therapeutics, BC Children's Hospital Research Institute, Department of Medical Genetics, University of British Columbia, Vancouver, British Columbia V5Z 4H4, Canada. Department of Ecology and Evolutionary Biology, University of Toronto, 25 Willcocks Street, Toronto, Ontario M5S 3B2, Canada. Child and Brain Development Program, Canadian Institute for Advanced Research (CIFAR), 180 Dundas Street West, Suite 1400, Toronto, Ontario M5G 1Z8, Canada.""}, {'ForeName': 'Weiping', 'Initials': 'W', 'LastName': 'Wen', 'Affiliation': 'Department of Otolaryngology, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China. Electronic address: wenwp@mail.sysu.edu.cn.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Carlsten', 'Affiliation': 'Air Pollution Exposure Laboratory, Department of Medicine, Division of Respiratory Medicine, The University of British Columbia, Vancouver, British Columbia, Canada. Electronic address: carlsten@mail.ubc.ca.'}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2020.08.044']
1422,33069784,"Rationale and design of a multicenter, randomized, patients-blinded two-stage clinical trial on effects of endothelial function test in patients with non-obstructive coronary artery disease (ENDOFIND).","Abnormal peripheral and coronary endothelial function has been associated with increased risk of major adverse cardiovascular events (MACE) in cross-sectional retrospective and observational studies. However, prognostic value of routine clinical evaluation, diagnosis and treatment of endothelial dysfunction on incident MACE in patients with non-obstructive coronary artery disease (NOCAD) remains unknown. Endothelial Function Guided Management in Patients with NOCAD (ENDOFIND) is a multicenter, randomized, patients-blinded, parallel-controlled, two-stage clinical trial evaluating the impact of routine clinical peripheral endothelial function testing on initiation and/or intensification of cardiovascular preventive therapies in Stage I, and on the risk of MACE in Stage II in patients with NOCAD. One thousand participants with NOCAD on clinically indicated coronary computed tomography or invasive angiography will be enrolled and randomized 1:1, after baseline peripheral endothelial function evaluation, to either endothelial function guided treatment group or standard of care control group. In Stage I, patients will be followed for 12 months and primary outcome will be the proportion of patients receiving prescriptions for cardiovascular evidence-based lipid, blood pressure and glucose lowering medications at the clinic visit immediately after endothelial function evaluation. Secondary outcomes are change in endothelial function measured as reactive hyperemia index and patients' adherence to evidence-based medications in 12 months. Study will be extended into Stage II where sample size and follow up duration will be reevaluated to ensure statistical power, and primary outcome will be incident MACE. ENDOFIND is proof-of-concept clinical trial of a disruptive endothelial function guided clinical intervention with potential benefits to NOCAD patients. CONDENSED ABSTRACT: ENDOFIND is a proof-of-concept clinical trial of a disruptive endothelial function guided clinical intervention with potential benefits to patients with no obstructive coronary artery disease (NOCAD). It is a multicenter, randomized, patients-blinded, parallel controlled two-stage clinical trial to evaluate the impact of routine clinical peripheral endothelial function testing on initiation and/or intensification of cardiovascular disease preventive therapies in Stage I, and on the risk of MACE in Stage II.",2020,Abnormal peripheral and coronary endothelial function has been associated with increased risk of major adverse cardiovascular events (MACE) in cross-sectional retrospective and observational studies.,"['One thousand participants with NOCAD on clinically indicated coronary computed tomography or invasive angiography', 'Patients with NOCAD', 'patients with non-obstructive coronary artery disease (NOCAD', 'patients with no obstructive coronary artery disease (NOCAD', 'patients with non-obstructive coronary artery disease (ENDOFIND', 'NOCAD patients', 'patients with NOCAD']","['endothelial function test', 'endothelial function guided treatment group or standard of care control group']","['proportion of patients receiving prescriptions for cardiovascular evidence-based lipid, blood pressure and glucose lowering medications', ""change in endothelial function measured as reactive hyperemia index and patients' adherence to evidence-based medications""]","[{'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205304', 'cui_str': 'Non-obstructive'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0178824', 'cui_str': 'Reactive Hyperemia'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",1000.0,0.232493,Abnormal peripheral and coronary endothelial function has been associated with increased risk of major adverse cardiovascular events (MACE) in cross-sectional retrospective and observational studies.,"[{'ForeName': 'Huan', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Vascular Medicine Center, Peking University Shougang Hospital, Beijing, PR China; Vascular Health Research Center of Peking University Health Science Center(VHRC-PKUHSC), Beijing, PR China.'}, {'ForeName': 'Gaoqiang', 'Initials': 'G', 'LastName': 'Xie', 'Affiliation': 'Peking University Clinical Research Institute, Peking University Health Science Center, Beijing, PR China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Huang', 'Affiliation': 'Vascular Medicine Center, Peking University Shougang Hospital, Beijing, PR China.'}, {'ForeName': 'Jinbo', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Vascular Medicine Center, Peking University Shougang Hospital, Beijing, PR China; Vascular Health Research Center of Peking University Health Science Center(VHRC-PKUHSC), Beijing, PR China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Zhao', 'Affiliation': 'Vascular Medicine Center, Peking University Shougang Hospital, Beijing, PR China.'}, {'ForeName': 'Michel T', 'Initials': 'MT', 'LastName': 'Corban', 'Affiliation': 'Department of Cardiovascular Diseases, Mayo Clinic College of Medicine and Science, Rochester, MN, USA.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Lerman', 'Affiliation': 'Department of Cardiovascular Diseases, Mayo Clinic College of Medicine and Science, Rochester, MN, USA.'}, {'ForeName': 'Yangfeng', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Vascular Health Research Center of Peking University Health Science Center(VHRC-PKUHSC), Beijing, PR China; Peking University Clinical Research Institute, Peking University Health Science Center, Beijing, PR China. Electronic address: wuyf@bjmu.edu.cn.'}, {'ForeName': 'Hongyu', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Vascular Medicine Center, Peking University Shougang Hospital, Beijing, PR China; Vascular Health Research Center of Peking University Health Science Center(VHRC-PKUHSC), Beijing, PR China; Peking University Clinical Research Institute, Peking University Health Science Center, Beijing, PR China; Key Laboratory of Molecular Cardiovascular Sciences (Peking University), Ministry of Education, Beijing, PR China. Electronic address: dr.hongyuwang@foxmail.com.'}]",International journal of cardiology,['10.1016/j.ijcard.2020.10.033']
1423,33069847,Percutaneous Coronary Intervention for Vulnerable Coronary Atherosclerotic Plaque.,"BACKGROUND


Acute coronary syndromes most commonly arise from thrombosis of lipid-rich coronary atheromas that have large plaque burden despite angiographically appearing mild.
OBJECTIVES


We sought to examine the outcomes of percutaneous coronary intervention (PCI) of non-flow-limiting vulnerable plaques.
METHODS


Three-vessel imaging was performed with a combination intravascular ultrasound (IVUS) and near-infrared spectroscopy (NIRS) catheter after successful PCI of all flow-limiting coronary lesions in 898 patients presenting with myocardial infarction (MI). Patients with an angiographically non-obstructive stenosis not intended for PCI but with IVUS plaque burden ≥65% were randomized to treatment of the lesion with a bioresorbable vascular scaffold (BVS) plus guideline-directed medical therapy (GDMT) vs. GDMT alone. The primary powered effectiveness endpoint was the IVUS-derived minimum lumen area (MLA) at protocol-driven 25-month follow-up. The primary (non-powered) safety endpoint was randomized target lesion failure (TLF; cardiac death, target vessel-related MI or clinically-driven target lesion revascularization) at 24 months. The secondary (non-powered) clinical effectiveness endpoint was randomized lesion-related major adverse cardiac events (MACE; cardiac death, MI, unstable angina, or progressive angina) at latest follow-up.
RESULTS


A total of 182 patients were randomized (93 BVS, 89 GDMT alone) at 15 centers. The median angiographic diameter stenosis of the randomized lesions was 41.6%; by NIRS-IVUS median plaque burden was 73.7%, median MLA was 2.9 mm 2 , and median maximum lipid plaque content was 33.4%. Angiographic follow-up at 25 months was completed in 167 patients (91.8%), and median clinical follow-up was 4.1 years. The follow-up MLA in BVS-treated lesions was 6.9±2.6 mm 2  compared with 3.0±1.0 mm 2  in GDMT alone-treated lesions (least square means difference 3.9 mm 2 , 95% CI 3.3-4.5, P<0.0001). TLF at 24 months occurred in similar rates of BVS-treated and GDMT alone-treated patients (4.3% vs. 4.5%; P=0.96). Randomized lesion-related MACE occurred in 4.3% BVS-treated patients vs. 10.7% GDMT alone-treated patients (OR 0.38, 95% CI 0.11-1.28, P=0.12).
CONCLUSIONS


PCI of angiographically mild lesions with large plaque burden was safe, substantially enlarged the follow-up MLA and was associated with favorable long-term clinical outcomes, warranting the performance of an adequately powered randomized trial.",2020,"GDMT alone-treated patients (OR 0.38, 95% CI 0.11-1.28, P=0.12).
","['Patients with an angiographically non-obstructive stenosis not intended for PCI but with IVUS plaque burden ≥65', '898 patients presenting with myocardial infarction (MI', '182 patients were randomized (93 BVS, 89 GDMT alone) at 15 centers']","['combination intravascular ultrasound (IVUS) and near-infrared spectroscopy (NIRS) catheter', 'bioresorbable vascular scaffold (BVS) plus guideline-directed medical therapy (GDMT) vs. GDMT alone', 'percutaneous coronary intervention (PCI', 'GDMT', 'TLF', 'Percutaneous Coronary Intervention']","['median maximum lipid plaque content', 'NIRS-IVUS median plaque burden', 'IVUS-derived minimum lumen area (MLA', 'adverse cardiac events (MACE; cardiac death, MI, unstable angina, or progressive angina) at latest follow-up', 'median MLA', 'median angiographic diameter stenosis', 'lesion failure (TLF; cardiac death, target vessel-related MI or clinically-driven target lesion revascularization']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205304', 'cui_str': 'Non-obstructive'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}, {'cui': 'C1283932', 'cui_str': 'Unintentional'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0442123', 'cui_str': 'Intravascular'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0337143', 'cui_str': 'Scaffold'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0442123', 'cui_str': 'Intravascular'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0376519', 'cui_str': 'Near-infrared spectroscopy'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0337143', 'cui_str': 'Scaffold'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0231174', 'cui_str': 'Failure'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0376519', 'cui_str': 'Near-infrared spectroscopy'}, {'cui': 'C0442123', 'cui_str': 'Intravascular'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0524461', 'cui_str': 'Structure of lumen of body system'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0002965', 'cui_str': 'Impending infarction'}, {'cui': 'C1299435', 'cui_str': 'Progressive angina'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0449618', 'cui_str': 'Target vessel'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}]",898.0,0.261215,"GDMT alone-treated patients (OR 0.38, 95% CI 0.11-1.28, P=0.12).
","[{'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA; The Cardiovascular Research Foundation, New York, NY, USA. Electronic address: Gregg.Stone@mountsinai.org.'}, {'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Maehara', 'Affiliation': 'The Cardiovascular Research Foundation, New York, NY, USA; New York-Presbyterian Hospital/Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Ziad A', 'Initials': 'ZA', 'LastName': 'Ali', 'Affiliation': 'The Cardiovascular Research Foundation, New York, NY, USA; New York-Presbyterian Hospital/Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Claes', 'Initials': 'C', 'LastName': 'Held', 'Affiliation': 'Uppsala University and Uppsala Clinical Research, Uppsala, Sweden.'}, {'ForeName': 'Mitsuaki', 'Initials': 'M', 'LastName': 'Matsumura', 'Affiliation': 'The Cardiovascular Research Foundation, New York, NY, USA.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Kjøller-Hansen', 'Affiliation': 'Zealand University Hospital, Roskilde, Denmark.'}, {'ForeName': 'Hans Erik', 'Initials': 'HE', 'LastName': 'Bøtker', 'Affiliation': 'Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Maeng', 'Affiliation': 'Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Engstrøm', 'Affiliation': 'University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Rune', 'Initials': 'R', 'LastName': 'Wiseth', 'Affiliation': 'St. Olavs Hospital, Trondheim University Hospital, Trondheim, Norway.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Persson', 'Affiliation': 'Danderyd Hospital, Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Thor', 'Initials': 'T', 'LastName': 'Trovik', 'Affiliation': 'University Hospital of North Norway, Tromsö, Norway.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Jensen', 'Affiliation': 'Södersjukhuset AB, Stockholm, Sweden.'}, {'ForeName': 'Stefan K', 'Initials': 'SK', 'LastName': 'James', 'Affiliation': 'Uppsala University and Uppsala Clinical Research, Uppsala, Sweden.'}, {'ForeName': 'Gary S', 'Initials': 'GS', 'LastName': 'Mintz', 'Affiliation': 'The Cardiovascular Research Foundation, New York, NY, USA.'}, {'ForeName': 'Ovidiu', 'Initials': 'O', 'LastName': 'Dressler', 'Affiliation': 'The Cardiovascular Research Foundation, New York, NY, USA.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Crowley', 'Affiliation': 'The Cardiovascular Research Foundation, New York, NY, USA.'}, {'ForeName': 'Ori', 'Initials': 'O', 'LastName': 'Ben-Yehuda', 'Affiliation': 'The Cardiovascular Research Foundation, New York, NY, USA; University of California San Diego, San Diego, CA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Erlinge', 'Affiliation': 'Clinical Sciences, Lund University, Lund, Sweden.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2020.09.547']
1424,33069871,A pilot randomized trial of contrast-rebalanced binocular treatment for deprivation amblyopia.,"BACKGROUND


Binocular neural architecture may be preserved in children with deprivation amblyopia due to unilateral cataract. The purpose of this study was to investigate whether a contrast-rebalanced binocular treatment, recently used with success to treat the interocular suppression and amblyopia in strabismic and anisometropic children, can contribute to rehabilitation of visual acuity in children with deprivation amblyopia secondary to monocular cataract.
METHODS


In a pilot randomized trial, 15 children (4-13 years of age) were enrolled and randomized to continue with their current treatment only (n = 7) or to continue with their current treatment and add contrast-rebalanced binocular iPad game play 5 hours/week for 4 weeks (n = 8). The primary outcome was change in visual acuity at 4 weeks.
RESULTS


Although 10 of 15 participants were patching, there was little change in visual acuity during the 3 months prior to enrollment. At the 4-week primary outcome visit, the mean improvement in visual acuity for the binocular game group was significantly greater than that for the current-treatment group (0.08 ± 0.10 logMAR vs -0.03 ± 0.05 logMAR [t 10.2  = 2.53, P = 0.03]). None of the children who had dense congenital cataract achieved improved visual acuity with binocular treatment.
CONCLUSIONS


In this study cohort, visual acuity improved over 8 weeks in children with unilateral deprivation amblyopia who played a binocular contrast-rebalanced binocular iPad game.",2020,"At the 4-week primary outcome visit, the mean improvement in visual acuity for the binocular game group was significantly greater than that for the current-treatment group (0.08 ± 0.10 logMAR vs -0.03 ± 0.05 logMAR [t 10.2  = 2.53, P = 0.03]).","['children with deprivation amblyopia due to unilateral cataract', 'children with unilateral deprivation amblyopia who played a binocular contrast-rebalanced binocular iPad game', 'deprivation amblyopia', 'strabismic and anisometropic children', 'children with deprivation amblyopia secondary to monocular cataract', '15 children (4-13 years of age']","['contrast-rebalanced binocular treatment', 'continue with their current treatment and add contrast-rebalanced binocular iPad game play']","['mean improvement in visual acuity', 'visual acuity']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0152189', 'cui_str': 'Stimulus deprivation amblyopia'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0521706', 'cui_str': 'Unilateral cataract'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C2594855', 'cui_str': 'Binoculars'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}, {'cui': 'C0086543', 'cui_str': 'Cataract'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C2594855', 'cui_str': 'Binoculars'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0032214', 'cui_str': 'Play'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}]",15.0,0.213266,"At the 4-week primary outcome visit, the mean improvement in visual acuity for the binocular game group was significantly greater than that for the current-treatment group (0.08 ± 0.10 logMAR vs -0.03 ± 0.05 logMAR [t 10.2  = 2.53, P = 0.03]).","[{'ForeName': 'Eileen E', 'Initials': 'EE', 'LastName': 'Birch', 'Affiliation': 'Retina Foundation of the Southwest, Dallas, Texas; Department of Ophthalmology, UT Southwestern Medical Center, Dallas, Texas. Electronic address: ebirch@rfsw.org.'}, {'ForeName': 'Reed M', 'Initials': 'RM', 'LastName': 'Jost', 'Affiliation': 'Retina Foundation of the Southwest, Dallas, Texas.'}, {'ForeName': 'Serena X', 'Initials': 'SX', 'LastName': 'Wang', 'Affiliation': 'Department of Ophthalmology, UT Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Krista R', 'Initials': 'KR', 'LastName': 'Kelly', 'Affiliation': 'Retina Foundation of the Southwest, Dallas, Texas; Department of Ophthalmology, UT Southwestern Medical Center, Dallas, Texas.'}]",Journal of AAPOS : the official publication of the American Association for Pediatric Ophthalmology and Strabismus,['10.1016/j.jaapos.2020.07.009']
1425,33070170,Horticultural Therapy Reduces Biomarkers of Immunosenescence and Inflammaging in Community-Dwelling Older Adults: A Feasibility Pilot Randomized Controlled Trial.,"BACKGROUND


With the challenges that aging populations pose to healthcare, interventions that facilitate alleviation of age-related morbidities are imperative. A prominent risk factor for developing age-related morbidities is immunosenescence, characterized by increased chronic low-grade inflammation, resulting in T-cell exhaustion and senescence. Contact with nature and associated physical activities have been shown to boost immunity in older adults and may be promoted in the form of Horticultural Therapy (HT). We aimed to examine the effects of HT on immunosenescence.
METHODS


We conducted a randomized controlled trial with 59 older adults assigned to either the HT intervention or waitlist control group. Older adults in the HT intervention group underwent HT intervention program over six months. Venous blood was drawn at baseline and at the 3 rd and 6 th month from the commencement of this study. For participants who attended all three blood collection time points (HT: n=22, waitlist: n=24), flow cytometry analysis was performed on whole blood samples to evaluate the kinetics of lymphocyte subsets over the intervention period, revealing the composition of CD4+ and CD8+ subsets expressing exhaustion markers - CD57, CTLA4, and KLRG1. Enzyme-linked immunosorbent assays were employed to measure changes in plasma IL-6 levels.
RESULTS


HT is associated with increased numbers of naïve CD8+ T cells and fewer CTLA4-expressing terminally differentiated effector CD4+ and CD8+ memory T cells re-expressing CD45RA (TEMRA). Furthermore, IL-6 levels were reduced during HT, and the frequencies of naive and TEMRA CD8+ T cells were found to be associated with IL-6 levels.
CONCLUSION


HT is associated with a reduction in the levels of biomarkers that measure the extent of T-cell exhaustion and inflammaging in older adults. The positive effects of HT on T-cell exhaustionwere associated with the reduction of IL-6 levels.",2020,HT is associated with a reduction in the levels of biomarkers that measure the extent of T-cell exhaustion and inflammaging in older adults.,"['older adults', 'Older adults', 'Community-Dwelling Older Adults', 'For participants who attended all three blood collection time points (HT: n=22, waitlist', '59 older adults']","['Horticultural Therapy', 'HT intervention', 'HT', 'HT intervention or waitlist control group', 'HT intervention program', 'KLRG1']","['Furthermore, IL-6 levels', 'Venous blood', 'plasma IL-6 levels', 'frequencies of naive and TEMRA CD8+ T cells', 'numbers of naïve CD8+ T cells and fewer CTLA4-expressing terminally differentiated effector CD4+ and CD8+ memory T cells re-expressing CD45RA (TEMRA', 'IL-6 levels']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0454057', 'cui_str': 'Horticultural therapy'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}]","[{'cui': 'C0454057', 'cui_str': 'Horticultural therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229667', 'cui_str': 'Venous blood'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0242629', 'cui_str': 'Lymphocyte positive for CD8 antigen'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205388', 'cui_str': 'Few'}, {'cui': 'C2350360', 'cui_str': 'CTLA4 protein, human'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0205615', 'cui_str': 'Well differentiated'}, {'cui': 'C4543203', 'cui_str': 'Effector'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0108789', 'cui_str': 'Lymphocyte antigen CD45RA'}]",59.0,0.0553324,HT is associated with a reduction in the levels of biomarkers that measure the extent of T-cell exhaustion and inflammaging in older adults.,"[{'ForeName': 'Glenn Choon Lim', 'Initials': 'GCL', 'LastName': 'Wong', 'Affiliation': 'Singapore Immunology Network, Agency for Science, Technology and Research, Singapore.'}, {'ForeName': 'Ted Kheng Siang', 'Initials': 'TKS', 'LastName': 'Ng', 'Affiliation': 'Department of Psychological Medicine, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'Jia Le', 'Initials': 'JL', 'LastName': 'Lee', 'Affiliation': 'Singapore Immunology Network, Agency for Science, Technology and Research, Singapore.'}, {'ForeName': 'Pei Yi', 'Initials': 'PY', 'LastName': 'Lim', 'Affiliation': 'Department of Biological Sciences, Singapore Polytechnic, Singapore.'}, {'ForeName': 'Sean Kai Jie', 'Initials': 'SKJ', 'LastName': 'Chua', 'Affiliation': 'Department of Biological Sciences, Singapore Polytechnic, Singapore.'}, {'ForeName': 'Crystal', 'Initials': 'C', 'LastName': 'Tan', 'Affiliation': 'Singapore Immunology Network, Agency for Science, Technology and Research, Singapore.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Chua', 'Affiliation': 'Singapore Immunology Network, Agency for Science, Technology and Research, Singapore.'}, {'ForeName': 'Janice', 'Initials': 'J', 'LastName': 'Tan', 'Affiliation': 'Singapore Immunology Network, Agency for Science, Technology and Research, Singapore.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Department of Biological Sciences, Singapore Polytechnic, Singapore.'}, {'ForeName': 'Angelia', 'Initials': 'A', 'LastName': 'Sia', 'Affiliation': 'Centre for Urban Greenery and Ecology Research, National Parks Board, Singapore.'}, {'ForeName': 'Maxel K W', 'Initials': 'MKW', 'LastName': 'Ng', 'Affiliation': 'Horticulture & Community Gardening Division, National Parks Board, Singapore.'}, {'ForeName': 'Rathi', 'Initials': 'R', 'LastName': 'Mahendran', 'Affiliation': 'Department of Psychological Medicine, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'Ee Heok', 'Initials': 'EH', 'LastName': 'Kua', 'Affiliation': 'Department of Psychological Medicine, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'Roger C M', 'Initials': 'RCM', 'LastName': 'Ho', 'Affiliation': 'Department of Psychological Medicine, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'Anis', 'Initials': 'A', 'LastName': 'Larbi', 'Affiliation': 'Singapore Immunology Network, Agency for Science, Technology and Research, Singapore.'}]","The journals of gerontology. Series A, Biological sciences and medical sciences",['10.1093/gerona/glaa271']
1426,33070223,Treatment with Laevo (L)-carnitine reverses the mitochondrial function of human embryos.,"PURPOSE


Laevo (l)-carnitine plays important roles in reducing the cytotoxic effects of free fatty acids by forming acyl-carnitine and promoting beta-oxidation, leading to alleviation of cell damage. Recently, the mitochondrial functions in morula has been shown to decrease with the maternal age. Here, we assessed the effect of l-carnitine on mitochondrial function in human embryos and embryo development.
METHODS


To examine the effect of L-carnitine on mitochondrial function in morulae, 38 vitrified-thawed embryos at the 6-11-cell stage on day 3 after ICSI were donated from 19 couples. Each couple donated two embryos. Two siblings from each couple were divided randomly into two groups and were cultured in medium with or without 1 mM L-carnitine. The oxygen consumption rates (OCRs) were measured at morula stage. The development of 1029 zygotes cultured in medium with or without L-carnitine was prospectively analyzed.
RESULTS


Addition of L-carnitine to the culture medium significantly increased the OCRs of morulae and improved the morphologically-good blastocyst formation rate per zygote compared with sibling embryos. Twenty healthy babies were born from embryos cultured in L-carnitine-supplemented medium after single embryo transfers.
CONCLUSION(S)


L-carnitine is a promising culture medium supplement that might be able to counteract the decreased mitochondrial function in human morula stage embryos.",2020,"RESULTS


Addition of L-carnitine to the culture medium significantly increased the OCRs of morulae and improved the morphologically-good blastocyst formation rate per zygote compared with sibling embryos.","['Twenty healthy babies were born from embryos cultured in L-carnitine-supplemented medium after single embryo transfers', 'human embryos and embryo development', 'Two siblings from each couple', 'morulae, 38 vitrified-thawed embryos at the 6-11-cell stage on day 3 after ICSI were donated from 19 couples']","['1029 zygotes cultured in medium with or without L-carnitine', 'cultured in medium with or without 1 mM L-carnitine', 'Laevo (L)-carnitine', 'l-carnitine', 'L-carnitine']","['oxygen consumption rates (OCRs', 'OCRs of morulae and improved the morphologically-good blastocyst formation rate per zygote', 'mitochondrial function of human embryos', 'mitochondrial function']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0920489', 'cui_str': 'Culture of embryo'}, {'cui': 'C0087163', 'cui_str': 'Levocarnitine'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C2717901', 'cui_str': 'Single Embryo Transfer'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0013935', 'cui_str': 'Embryos'}, {'cui': 'C0013936', 'cui_str': 'Embryo Development'}, {'cui': 'C0037047', 'cui_str': 'Sibling'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0455164', 'cui_str': 'IVF - In vitro fertilization with intracytoplasmic sperm injection (ICSI)'}]","[{'cui': 'C0043544', 'cui_str': 'Structure of zygote'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0087163', 'cui_str': 'Levocarnitine'}, {'cui': 'C0007258', 'cui_str': 'Carnitine'}]","[{'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1281743', 'cui_str': 'Blastocyst structure'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0043544', 'cui_str': 'Structure of zygote'}, {'cui': 'C0026237', 'cui_str': 'Mitochondrion'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0013935', 'cui_str': 'Embryos'}]",1029.0,0.0234196,"RESULTS


Addition of L-carnitine to the culture medium significantly increased the OCRs of morulae and improved the morphologically-good blastocyst formation rate per zygote compared with sibling embryos.","[{'ForeName': 'Naoharu', 'Initials': 'N', 'LastName': 'Morimoto', 'Affiliation': 'IVF Namba Clinic, Osaka, 550-0015, Japan.'}, {'ForeName': 'Shu', 'Initials': 'S', 'LastName': 'Hashimoto', 'Affiliation': 'Graduate School of Medicine, Osaka City University, Osaka, 545-8585, Japan. hashimoto@ivfnamba.com.'}, {'ForeName': 'Masaya', 'Initials': 'M', 'LastName': 'Yamanaka', 'Affiliation': 'IVF Namba Clinic, Osaka, 550-0015, Japan.'}, {'ForeName': 'Manabu', 'Initials': 'M', 'LastName': 'Satoh', 'Affiliation': 'IVF Namba Clinic, Osaka, 550-0015, Japan.'}, {'ForeName': 'Yoshiharu', 'Initials': 'Y', 'LastName': 'Nakaoka', 'Affiliation': 'IVF Namba Clinic, Osaka, 550-0015, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Fukui', 'Affiliation': 'Department of Obstetrics and Gynecology, Hyogo College of Medicine, Nishinomiya, Hyogo, 663-8501, Japan.'}, {'ForeName': 'Yoshiharu', 'Initials': 'Y', 'LastName': 'Morimoto', 'Affiliation': 'HORAC Grand Front Osaka Clinic, Osaka, 530-0011, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Shibahara', 'Affiliation': 'Department of Obstetrics and Gynecology, Hyogo College of Medicine, Nishinomiya, Hyogo, 663-8501, Japan.'}]",Journal of assisted reproduction and genetics,['10.1007/s10815-020-01973-6']
1427,33070235,"Intraoperative findings, complications, and short-term results after lumbar microdiscectomy with or without implantation of annular closure device.","BACKGROUND


Standard microscopic lumbar discectomy (MLD) is a short operation with minimal blood loss, and a low rate of peri- and intraoperative complications. The objective of this study was to evaluate intraoperative findings, complications, and early postoperative neurological outcome (< 105 days) in patients undergoing MLD with or without implantation of an annular closure device (ACD).
METHODS


This study is based on data analysis of a post-marketing, prospective, multicenter RCT in Europe including patients undergoing standard MLD with or without implantation of an ACD (Barricaid®, Intrinsic Therapeutics, Inc., Woburn, MA). Enrollment of 554 patients in 21 centers in Europe (Germany, Switzerland, Austria, Belgium, The Netherlands, and France) started in 2010 and was completed in October 2014, with 276 patients randomized to the ACD group and 278 to the control group.
RESULTS


Mean operation time was 70 min in the ACD group and 52 min in the control group (p < 0.0001). Intraoperative fluoroscopy time was 24 s in the ACD group and 7 s in the control group (p < 0.0001). Average blood loss was 94.2 ml in the ACD group and 64.7 ml in the control group (p = 0.0001). Serious device- or procedure-related adverse events occurred in 3.7% (10/272) of the ACD group and 7.9% (22/278) of the control group. Dural injuries occurred in 13 (4.8%) patients in the ACD group and 7 (2.5%) in the control group. There was one device-related nerve root injury resulting in a nerve root amputation. Surgical complications included 3 hematomas in the ACD group and 4 in the control group; 3 infections occurred in both groups. Device migrations were documented in 3 patients in the ACD group. Patients in the ACD group (n = 7, 2.6%) underwent fewer reoperations compared with that in the control group (n = 16, 5.8%, OR = 2.3 (0.9-5.7)). Mean VAS leg pain at 3 months was 11.9 in the ACD and 15.1 in the control group, respectively.
CONCLUSION


Short-term outcome after MLD with or without implantation of ACD was similar in both groups. Patients included in the ACD group underwent fewer reoperations in the first 3 months after surgery. Nevertheless, longer operation time, higher amount of blood loss, and risk of nerve root lesion during device implantation should be considered additional risks in patients undergoing ACD implantation after MLD.",2020,"Mean VAS leg pain at 3 months was 11.9 in the ACD and 15.1 in the control group, respectively.
","['patients undergoing ACD implantation after MLD', '554 patients in 21 centers in Europe (Germany, Switzerland, Austria, Belgium, The Netherlands, and France) started in 2010 and was completed in October 2014, with 276 patients randomized to the ACD group and 278 to the control group', 'Europe including patients undergoing standard MLD with or without implantation of an ACD (Barricaid®, Intrinsic Therapeutics, Inc., Woburn, MA', 'patients undergoing MLD with or without implantation of an annular closure device (ACD']","['ACD', 'microscopic lumbar discectomy (MLD']","['Dural injuries', 'Mean operation time', 'Mean VAS leg pain', 'Average blood loss', 'Device migrations', 'Serious device- or procedure-related adverse events', 'longer operation time, higher amount of blood loss, and risk of nerve root lesion', 'intraoperative findings, complications, and early postoperative neurological outcome', 'Intraoperative fluoroscopy time']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002873', 'cui_str': 'Anemia of chronic disease'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0205288', 'cui_str': 'Microscopic'}, {'cui': 'C0408632', 'cui_str': 'Excision of lumbar intervertebral disc'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0004348', 'cui_str': 'Austria'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0105231', 'cui_str': 'Periodontal pack - light-curing system'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0521164', 'cui_str': 'Annular shape'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0002873', 'cui_str': 'Anemia of chronic disease'}, {'cui': 'C0205288', 'cui_str': 'Microscopic'}, {'cui': 'C0408632', 'cui_str': 'Excision of lumbar intervertebral disc'}]","[{'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0023222', 'cui_str': 'Pain in lower limb'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0549474', 'cui_str': 'Device migration'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0235919', 'cui_str': 'Nerve root lesion'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}]",276.0,0.0522238,"Mean VAS leg pain at 3 months was 11.9 in the ACD and 15.1 in the control group, respectively.
","[{'ForeName': 'Jenny C', 'Initials': 'JC', 'LastName': 'Kienzler', 'Affiliation': 'Department of Neurosurgery, Kantonsspital Aarau, Aarau, Switzerland.'}, {'ForeName': 'Volkmar', 'Initials': 'V', 'LastName': 'Heidecke', 'Affiliation': 'Department of Neurosurgery, Klinikum Augsburg, Augsburg, Germany.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Assaker', 'Affiliation': 'Department of Neurosurgery, Centre Hospitalier Régional Universitaire of Lille, Lille, France.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Fandino', 'Affiliation': 'Department of Neurosurgery, Kantonsspital Aarau, Aarau, Switzerland. fandino@neurochirurgie-ag.ch.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Barth', 'Affiliation': 'Department of Neurosurgery, Klinikum Frankfurt, Frankfurt, Germany.'}]",Acta neurochirurgica,['10.1007/s00701-020-04612-2']
1428,33070244,Preventing the Onset of Anxiety Disorders in Offspring of Anxious Parents: A Six-Year Follow-up.,"This study examined the effects of a family-based intervention Coping and Promoting Strength (CAPS) relative to a control condition, information-monitoring (IM), to prevent the onset of anxiety disorders in offspring of anxious parents six years after their initial assessment. One hundred thirty six families participated in the original randomized trial; 113 (83%) completed the one time follow-up assessment. Presence of anxiety disorders and severity of symptoms in offspring were assessed by masked evaluators using the Anxiety Disorders Interview Schedule; parents and offspring also completed questionnaires assessing offspring anxiety. Using the intention to treat sample from the original trial, Cox regression models showed significant intervention main effects in the rate of onset of anxiety disorders from baseline to follow-up (anxiety disorder: hazard ratio (HR) = 2.55, 95% CI: 1.54, 4.21) but growth curves suggest effects occurred within the first year after program completion. No group differences were found in the cumulative incidence of anxiety disorders at the six-year follow-up. Additional intervention appears needed to maintain the initial positive effects long-term to reduce the risk for downstream disability.Clinical Trials Registration: NCT00847561.",2020,No group differences were found in the cumulative incidence of anxiety disorders at the six-year follow-up.,"['One hundred thirty six families participated in the original randomized trial; 113 (83%) completed the one time follow-up assessment', 'offspring of anxious parents six\xa0years after their initial assessment', 'Offspring of Anxious Parents']","['family-based intervention Coping and Promoting Strength (CAPS) relative to a control condition, information-monitoring (IM']","['cumulative incidence of anxiety disorders', 'rate of onset of anxiety disorders']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0577602', 'cui_str': 'Parental anxiety'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}]",136.0,0.0346083,No group differences were found in the cumulative incidence of anxiety disorders at the six-year follow-up.,"[{'ForeName': 'Golda S', 'Initials': 'GS', 'LastName': 'Ginsburg', 'Affiliation': 'Department of Psychiatry, University of Connecticut School of Medicine, 65 Kane Street Room 2033, West Hartford, CT, 06119, USA. gginsburg@uchc.edu.'}, {'ForeName': 'Jenn-Yun', 'Initials': 'JY', 'LastName': 'Tein', 'Affiliation': 'Department of Psychology, Arizona State University, Tempe, USA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Riddle', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, The Johns Hopkins University School of Medicine, Baltimore, USA.'}]",Child psychiatry and human development,['10.1007/s10578-020-01080-8']
1429,33070249,"Recombinant human endostatin plus paclitaxel/nedaplatin for recurrent or metastatic advanced esophageal squamous cell carcinoma: a prospective, single-arm, open-label, phase II study.","Background The prognosis of esophageal squamous cell carcinoma (ESCC) are still poor. Nedaplatin/paclitaxel regimen has shown activity with lower toxicity in metastatic ESCC. Recombinant human endostatin (Rh-endostatin), an inhibitor of angiogenesis, has shown inhibitory effects on ESCC xenograft. We assessed the activity and safety of Rh-endostatin plus paclitaxel/nedaplatin in patients with recurrent or metastatic advanced ESCC. Methods In this single-center, open-label, single-arm, phase II study, patients with recurrent/metastatic or unresectable advanced ESCC were recruited. Eligible patients received the multidrug combination therapy with Rh-endostatin (30 mg/day on days 1-14), paclitaxel (150 mg/m 2  on day 4) and nedaplatin (80 mg/m 2  on day 4) every 3 weeks. The primary endpoint was progression-free survival. Secondary endpoints included objective response rate, disease control rate, overall survival. Results Between Jan 29, 2015 and Dec 31, 2019, 53 patients were enrolled and received at least one dose of Rh-endostatin. Median progression-free survival was 5.1 months (95% CI: 3.7-6.6), with a 6 month progression-free survival of 41% (95% CI: 25-56). Median overall survival was 13.2 months (95% CI: 8.0-18.4), with a 1-year overall survival of 51% (95% CI: 36-67). 21 (42%, 95% CI: 28-56) of 50 patients had an objective response and 35 (70.00%, 95% CI: 57-83) had a disease control. Treatment-related adverse events of grade 3 or worse were reported in 13 (24.5%) patients. The most common grade 3 or 4 treatment-related adverse events were neutropenia (9 patients [17%]) and anaemia (2 [3.8%]). No treatment-related death occurred. Conclusions Rh-endostatin plus paclitaxel/nedaplatin has anti-tumour activity with acceptable tolerability in patients with recurrent or metastatic advanced ESCC. Randomized controlled trial is needed to confirm the efficacy of this regimen.",2020,"Median progression-free survival was 5.1 months (95% CI: 3.7-6.6), with a 6 month progression-free survival of 41% (95% CI: 25-56).","['patients with recurrent or metastatic advanced ESCC', 'Between Jan 29, 2015 and Dec 31, 2019, 53 patients were enrolled and received at least one dose of', 'recurrent or metastatic advanced esophageal squamous cell carcinoma', 'patients with recurrent/metastatic or unresectable advanced ESCC were recruited']","['Recombinant human endostatin (Rh-endostatin', 'Nedaplatin/paclitaxel', 'multidrug combination therapy with Rh-endostatin', 'Rh-endostatin plus paclitaxel/nedaplatin', 'paclitaxel', 'Recombinant human endostatin plus paclitaxel/nedaplatin', 'nedaplatin', 'Rh-endostatin']","['objective response rate, disease control rate, overall survival', 'activity and safety', 'objective response', 'disease control', 'neutropenia', 'anaemia', 'Median overall survival', 'progression-free survival', '1-year overall survival', 'Median progression-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0279626', 'cui_str': 'Squamous cell carcinoma of esophagus'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0534628', 'cui_str': 'Endostatin'}, {'cui': 'C0093999', 'cui_str': 'nedaplatin'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0439234', 'cui_str': 'year'}]",53.0,0.195389,"Median progression-free survival was 5.1 months (95% CI: 3.7-6.6), with a 6 month progression-free survival of 41% (95% CI: 25-56).","[{'ForeName': 'Zhi-Qiang', 'Initials': 'ZQ', 'LastName': 'Wang', 'Affiliation': 'Department of Medical Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, No. 651, Dongfeng Road East, 510060, Guangzhou, China.'}, {'ForeName': 'De-Shen', 'Initials': 'DS', 'LastName': 'Wang', 'Affiliation': 'Department of Medical Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, No. 651, Dongfeng Road East, 510060, Guangzhou, China.'}, {'ForeName': 'Feng-Hua', 'Initials': 'FH', 'LastName': 'Wang', 'Affiliation': 'Department of Medical Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, No. 651, Dongfeng Road East, 510060, Guangzhou, China.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Ren', 'Affiliation': 'Department of Medical Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, No. 651, Dongfeng Road East, 510060, Guangzhou, China.'}, {'ForeName': 'Qiong', 'Initials': 'Q', 'LastName': 'Tan', 'Affiliation': 'Department of Medical Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, No. 651, Dongfeng Road East, 510060, Guangzhou, China.'}, {'ForeName': 'Yu-Hong', 'Initials': 'YH', 'LastName': 'Li', 'Affiliation': 'Department of Medical Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, No. 651, Dongfeng Road East, 510060, Guangzhou, China. liyh@sysucc.org.cn.'}]",Investigational new drugs,['10.1007/s10637-020-01021-1']
1430,33070253,RANKL as a therapeutic target of rheumatoid arthritis.,"Rheumatoid arthritis (RA) is an inflammatory disorder characterized by progressive joint destruction. Recent studies have demonstrated that osteoclasts are responsible for bone destruction in RA. Receptor activator of nuclear factor kappa B ligand (RANKL), an osteoclast differentiation factor, belongs to the tumor necrosis factor superfamily and plays a critical role in osteoclast differentiation. RANKL is highly expressed in the synovial tissues in patients with RA and is involved in osteoclast development and thus bone destruction in RA. Denosumab, a specific antibody to human RANKL, efficiently suppressed the progression of bone destruction in patients with RA in a randomized controlled study and is considered a putative therapeutic option for RA.",2020,"Denosumab, a specific antibody to human RANKL, efficiently suppressed the progression of bone destruction in patients with RA in a randomized controlled study and is considered a putative therapeutic option for RA.",['patients with RA'],['Denosumab'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}]","[{'cui': 'C1690432', 'cui_str': 'denosumab'}]",[],,0.0149089,"Denosumab, a specific antibody to human RANKL, efficiently suppressed the progression of bone destruction in patients with RA in a randomized controlled study and is considered a putative therapeutic option for RA.","[{'ForeName': 'Sakae', 'Initials': 'S', 'LastName': 'Tanaka', 'Affiliation': 'Department of Orthopaedic Surgery, Faculty of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan. TANAKAS-ORT@h.u-tokyo.ac.jp.'}, {'ForeName': 'Yoshiya', 'Initials': 'Y', 'LastName': 'Tanaka', 'Affiliation': 'First Department of Internal Medicine, University of Occupational and Environmental Health, 1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu, Fukuoka, 807-8555, Japan.'}]",Journal of bone and mineral metabolism,['10.1007/s00774-020-01159-1']
1431,33070271,Comparison of medial rectus resection and plication in exotropic patients.,"PURPOSE


To compare the surgical outcomes of the plication technique with the resection method to treat exotropic patients.
METHODS


In this prospective randomized clinical trial, a total of 52 exotropic patients (27 females and 25 males) who were candidates for medial rectus resection were randomly classified into the plication (n = 24) and resection (n = 28) groups. Comprehensive ophthalmic examination included cyclorefraction, assessment of the best corrected visual acuity (BCVA), evaluation of the extraocular muscle, ocular deviation measurement and stereopsis measured using a Titmus test. Ocular anterior and posterior segments were examined using slit-lamp and indirect ophthalmoscopy. Patients were randomly divided to medial rectus plication and medial rectus resection groups. The plication technique was the same as for resection, but in the last step the muscle was folded. Examinations were repeated at the 1- and 3-day as well as 1-, 2-, 3- and 6-month follow-ups. If the postoperative ocular deviation was in the range of 5 PD esotropia to 10 PD exotropia, it was considered a successful surgical outcome.
RESULTS


Results show that there was no statistically significant difference between the two groups regarding near and far deviations (P N  = 0.298, P F  = 0.103), surgical dose response (P = 0.904) and postoperative success rate (plication, 87% and resection, 89.3%, P > 0.99). Reoperation was needed in 13% and 10.7% of the plication and resection groups, respectively (P > 0.05).
CONCLUSIONS


Medial rectus plication is an effective and appropriate alternative option for medial rectus resection in exotropic patients.",2020,"Reoperation was needed in 13% and 10.7% of the plication and resection groups, respectively (P > 0.05).
","['exotropic patients', '52 exotropic patients (27 females and 25 males) who were candidates for medial rectus resection were randomly classified into the plication (n\u2009=\u200924) and resection (n\u2009=\u200928) groups']","['Medial rectus plication', 'medial rectus resection and plication', 'plication technique', 'medial rectus plication and medial rectus resection groups']","['surgical dose response', 'corrected visual acuity (BCVA), evaluation of the extraocular muscle, ocular deviation measurement and stereopsis measured using a Titmus test', 'Reoperation', 'postoperative success rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0395297', 'cui_str': 'Medial rectus resection'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0185026', 'cui_str': 'Plication'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0582820', 'cui_str': 'Medial rectus muscle structure'}, {'cui': 'C0185026', 'cui_str': 'Plication'}, {'cui': 'C0395297', 'cui_str': 'Medial rectus resection'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0028863', 'cui_str': 'Structure of extraocular muscle'}, {'cui': 'C1112602', 'cui_str': 'Ocular deviation'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0011586', 'cui_str': 'Stereoscopic vision'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",52.0,0.0217536,"Reoperation was needed in 13% and 10.7% of the plication and resection groups, respectively (P > 0.05).
","[{'ForeName': 'Zhale', 'Initials': 'Z', 'LastName': 'Rajavi', 'Affiliation': 'Negah Specialty Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Saideh', 'Initials': 'S', 'LastName': 'Arabikhalilabad', 'Affiliation': 'Ophthalmic Research Center, Research Institute for Ophthalmology and Vision Science, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hamideh', 'Initials': 'H', 'LastName': 'Sabbaghi', 'Affiliation': 'Ophthalmic Epidemiology Research Center, Research Institute for Ophthalmology and Vision Science, Shahid Beheshti University of Medical Sciences, 23 Paidar Fard, Bostan 9, Pasdaran Ave., Tehran, 16666, Iran. Sabbaghi.opt@gmail.com.'}, {'ForeName': 'Bahareh', 'Initials': 'B', 'LastName': 'Kheiri', 'Affiliation': 'Ophthalmic Research Center, Research Institute for Ophthalmology and Vision Science, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Saied', 'Initials': 'S', 'LastName': 'Abdi', 'Affiliation': 'Department of Optometry, School of Rehabilitation, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",International ophthalmology,['10.1007/s10792-020-01546-7']
1432,33070326,Effectiveness of water as the neutralising agent for glycolic acid peels in skin phototypes IV-V.,"The aim of the study is to evaluate the effectiveness of water as a substitute for sodium bicarbonate plus solution in the neutralisation process of chemical peeling using a 35% glycolic acid solution. This randomised, double-blind, split-face, controlled trial was conducted in an outpatient setting. A total of 126 healthy patients with skin phototypes IV-V aged between 18 and 60 years old were recruited. Chemical peeling was performed with 35% glycolic acid solution. One side of the face was neutralised with water, and the other side of the face was neutralised with a sodium bicarbonate plus solution. The main outcome of this study was measured by the degree of erythema, pruritus and pain scores. Significant difference in the pain score immediately after the neutralisation process of the chemical peeling with glycolic acid was seen. However, there were no significant differences in the degree of erythema or the pruritus score. These results indicate that water can be used as a substitute for sodium bicarbonate plus solution in the neutralisation process of chemical peeling with 35% glycolic acid in patients with skin phototypes IV-V.",2020,Significant difference in the pain score immediately after the neutralisation process of the chemical peeling with glycolic acid was seen.,"['126 healthy patients with skin phototypes IV-V aged between 18 and 60\xa0years old were recruited', 'patients with skin phototypes IV-V', 'skin phototypes IV-V']","['sodium bicarbonate plus solution', 'Chemical peeling was performed with 35% glycolic acid solution']","['pain score', 'degree of erythema or the pruritus score', 'degree of erythema, pruritus and pain scores']","[{'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0074722', 'cui_str': 'Sodium Bicarbonate'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0411412', 'cui_str': 'Chemical peeling of skin lesion'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C1533643', 'cui_str': 'Glycolic acid'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",126.0,0.0527254,Significant difference in the pain score immediately after the neutralisation process of the chemical peeling with glycolic acid was seen.,"[{'ForeName': 'Irma Bernadette S', 'Initials': 'IBS', 'LastName': 'Sitohang', 'Affiliation': 'Department of Dermatology and Venereology, Faculty of Medicine Universitas Indonesia, dr. Cipto Mangunkusumo Hospital, Jakarta, Indonesia.'}, {'ForeName': 'Githa', 'Initials': 'G', 'LastName': 'Rahmayunita', 'Affiliation': 'Department of Dermatology and Venereology, Faculty of Medicine Universitas Indonesia, dr. Cipto Mangunkusumo Hospital, Jakarta, Indonesia.'}, {'ForeName': 'Vashty Amanda', 'Initials': 'VA', 'LastName': 'Hosfiar', 'Affiliation': 'Department of Dermatology and Venereology, Faculty of Medicine Universitas Indonesia, dr. Cipto Mangunkusumo Hospital, Jakarta, Indonesia.'}, {'ForeName': 'Shafira', 'Initials': 'S', 'LastName': 'Ninditya', 'Affiliation': 'Department of Dermatology and Venereology, Faculty of Medicine Universitas Indonesia, dr. Cipto Mangunkusumo Hospital, Jakarta, Indonesia.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Augustin', 'Affiliation': 'Department of Dermatology and Venereology, Faculty of Medicine Universitas Indonesia, dr. Cipto Mangunkusumo Hospital, Jakarta, Indonesia.'}]",The Australasian journal of dermatology,['10.1111/ajd.13486']
1433,33070354,"Adherence to and acceptability of three alcohol-free, antiseptic oral rinses: A community-based pilot randomized controlled trial among pregnant women in rural Nepal.","OBJECTIVES


Antiseptic oral rinses have been evaluated as interventions to reduce the risk of adverse pregnancy outcomes associated with periodontal disease in pregnant women. Oral rinse use is not common in Nepal or other countries in South Asia, where the prevalence of adverse pregnancy outcomes is high. Understanding whether pregnant women in rural communities in this region would incorporate rinse use into their daily teeth cleaning routine is an important prerequisite to future research on this topic in South Asia.
METHODS


We conducted a community-based pilot randomized controlled trial of three alcohol-free, antiseptic oral rinses among pregnant women <22 weeks pregnant in rural Nepal with the aim of assessing rinse acceptability, adherence, and effect on clinical periodontal measures. At baseline, participants underwent a clinical periodontal examination, and then were classified as healthy or having at least mild gingivitis (≥1 site with probing depth (PD) 3 mm and bleeding on probing (BOP) or ≥4 mm (PD)). Participants were stratified by periodontal status and randomized within each exposure category to chlorhexidine (CHX) (0.12%), cetylpyridinium chloride (CPC) (0.05%), salt and water (NaCl), or control (no rinse). Rinse participants were followed weekly for 12 weeks, and all participants underwent a second periodontal examination and answered a questionnaire.
RESULTS


Pregnant women in the rural Terai region of Nepal showed high adherence to (mean weekly rinse use: 185 mL (standard deviation: 66 mL)) a recommended 210 mL and acceptability of all three rinses. Participants reported greater frequency of tooth brushing with toothpaste and improvements in other recommended oral hygiene behaviours. CHX significantly reduced rates of gingivitis (defined as a participant with BOP ≥ 10% of sites) and the extent of BOP (gingivitis at the end of follow-up for CHX vs control: RR 0.37, 95% CI: 0.16, 0.84). CPC and NaCl rinse groups had rates of gingivitis and extent of BOP similar to the control group (gingivitis at the end of follow-up for CPC: RR 0.81, 95% CI: 0.47, 1.38; NaCl: RR 0.92, 95% CI: 0.55, 1.56).
CONCLUSIONS


Adherence to and acceptability of three alcohol-free, antiseptic oral rinses were high among pregnant women in rural Nepal. Among participants with mild gingivitis at baseline, CHX rinse was most effective at reducing signs of disease compared to the control group. Oral rinse should be considered as a supplement to current oral self-care routines for pregnant women in settings where rinse use is uncommon and access to oral health services is limited.",2020,"CPC and NaCl rinse groups had rates of gingivitis and extent of BOP similar to the control group (gingivitis at the end of follow-up for CPC: RR 0.81, 95% CI: 0.47, 1.38; NaCl: RR 0.92, 95% CI: 0.55, 1.56).
","['participants with mild gingivitis', 'Pregnant women in the rural Terai region of Nepal', 'pregnant women in rural communities', 'pregnant women', 'pregnant women in rural Nepal', 'participants underwent a clinical periodontal examination, and then were classified as healthy or having at least mild gingivitis (≥1 site with probing depth (PD) 3\xa0mm and bleeding on probing (BOP) or ≥4\xa0mm (PD', 'pregnant women <22\xa0weeks pregnant in rural Nepal']","['chlorhexidine (CHX', 'alcohol-free, antiseptic oral rinses', 'cetylpyridinium chloride (CPC) (0.05%), salt and water (NaCl), or control (no rinse', 'CPC and NaCl rinse', 'CHX']","['BOP (gingivitis', 'rates of gingivitis and extent of BOP', 'frequency of tooth brushing', 'rates of gingivitis']","[{'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0027689', 'cui_str': 'Nepal'}, {'cui': 'C0086944', 'cui_str': 'Rural Communities'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0460089', 'cui_str': 'Finding of length of gestation'}]","[{'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0003205', 'cui_str': 'Antiseptic agent'}, {'cui': 'C0026647', 'cui_str': 'Oromucosal solution for gargle'}, {'cui': 'C0007907', 'cui_str': 'Cetylpyridinium chloride'}, {'cui': 'C4517411', 'cui_str': '0.05'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1701810', 'cui_str': 'Rinse'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}]","[{'cui': 'C0796232', 'cui_str': 'Bohring Opitz syndrome'}, {'cui': 'C0008684', 'cui_str': 'Chronic gingivitis'}, {'cui': 'C0439792', 'cui_str': 'Extent'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0040461', 'cui_str': 'Brushing of teeth'}]",3.0,0.121734,"CPC and NaCl rinse groups had rates of gingivitis and extent of BOP similar to the control group (gingivitis at the end of follow-up for CPC: RR 0.81, 95% CI: 0.47, 1.38; NaCl: RR 0.92, 95% CI: 0.55, 1.56).
","[{'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Erchick', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Nitin K', 'Initials': 'NK', 'LastName': 'Agrawal', 'Affiliation': 'Department of Dentistry, Institute of Medicine, Tribhuhvan University, Kathmandu, Nepal.'}, {'ForeName': 'Subarna K', 'Initials': 'SK', 'LastName': 'Khatry', 'Affiliation': 'Nepal Nutrition Intervention Project - Sarlahi (NNIPS), Kathmandu, Nepal.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Katz', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Steven C', 'Initials': 'SC', 'LastName': 'LeClerq', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Reynolds', 'Affiliation': 'Department of Advanced Oral Sciences and Therapeutics, University of Maryland School of Dentistry, Baltimore, MD, USA.'}, {'ForeName': 'Luke C', 'Initials': 'LC', 'LastName': 'Mullany', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}]",Community dentistry and oral epidemiology,['10.1111/cdoe.12562']
1434,33070366,Randomized trial of 3 maintenance regimens (tac/srl vs. tac/mmf vs. csa/srl) with low dose corticosteroids in primary kidney transplantation: 18 year results.,"A randomized trial of 150 primary kidney transplant recipients, initiated in May,2000, compared tacrolimus(TAC)/sirolimus(SRL) vs. TAC/mycophenolate mofetil(MMF) vs. cyclosporine microemulsion(CSA)/SRL(N=50/group). All patients received daclizumab induction and maintenance corticosteroids. With current median follow-up of 18yr post-transplant, biopsy-proven acute rejection(BPAR) occurred less often in TAC/MMF, 26%(13/50), vs. the TAC/SRL (36%(18/50)) and CSA/SRL (34%(17/50)) arms combined(P=.23), with statistical significance favoring TAC/MMF(P=.05) after controlling for the multivariable(Cox model) effects of recipient age, recipient race/ethnicity, and donor age. First BPAR rate was clearly more favorable for TAC/MMF after stratifying patients by having 0-1(N=72) vs. 2-3(N=78) unfavorable baseline characteristics(recipient age<50yr, African-American or Hispanic recipient, and donor age≥50yr)(P=.02). Mean estimated glomerular filtration rate(eGFR), using the CKD-EPI formula, was consistently higher for TAC/MMF, particularly after controlling for the multivariable effect of donor age, throughout the first 96mo post-transplant(P≤.008). These differences translated into an observed more favorable graft failure due-to-immunologic cause(CAI/TG) rate for TAC/MMF(P=.06), although no significant differences in overall death-uncensored graft loss were observed. Previously reported significantly higher study drug discontinuation and requirement-for-anti-lipid therapy rates in the SRL-assigned arms were maintained over time. Overall, these results at 18yr post-transplant more definitively show that TAC/MMF should be the gold standard for achieving optimal, long-term maintenance immunosuppression in kidney transplantation.",2020,"arms combined(P=.23), with statistical significance favoring TAC/MMF(P=.05) after controlling for the multivariable(Cox model) effects of recipient age, recipient race/ethnicity, and donor age.","['primary kidney transplantation', '150 primary kidney transplant recipients, initiated in May,2000, compared']","['daclizumab induction and maintenance corticosteroids', 'TAC/MMF', 'tacrolimus(TAC)/sirolimus(SRL) vs. TAC/mycophenolate mofetil(MMF) vs. cyclosporine microemulsion(CSA)/SRL(N=50/group', 'maintenance regimens (tac/srl vs. tac/mmf vs. csa/srl) with low dose corticosteroids']","['overall death-uncensored graft loss', 'TAC/SRL (36%(18/50)) and CSA/SRL (34%(17/50', 'First BPAR rate', 'Mean estimated glomerular filtration rate(eGFR', 'study drug discontinuation and requirement-for-anti-lipid therapy rates']","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C4321486', 'cui_str': '150'}]","[{'cui': 'C0663182', 'cui_str': 'Daclizumab'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0883242', 'cui_str': 'MYCOPHENOLATE'}, {'cui': 'C1577018', 'cui_str': 'cyclosporine microemulsion'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C3489891', 'cui_str': 'TAC Alternate'}, {'cui': 'C0083765', 'cui_str': 'NMF protocol'}, {'cui': 'C0010592', 'cui_str': 'Cyclosporine'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0877042', 'cui_str': 'Graft loss'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0010592', 'cui_str': 'Cyclosporine'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0035015', 'cui_str': 'Rejection (Psychology)'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0232809', 'cui_str': 'Glomerular filtration'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]",150.0,0.0733256,"arms combined(P=.23), with statistical significance favoring TAC/MMF(P=.05) after controlling for the multivariable(Cox model) effects of recipient age, recipient race/ethnicity, and donor age.","[{'ForeName': 'Gaetano', 'Initials': 'G', 'LastName': 'Ciancio', 'Affiliation': 'Miami Transplant Institute, Department of Medicine, Leonard M. Miller School of Medicine, University of Miami, USA.'}, {'ForeName': 'Jeffrey J', 'Initials': 'JJ', 'LastName': 'Gaynor', 'Affiliation': 'Miami Transplant Institute, Department of Medicine, Leonard M. Miller School of Medicine, University of Miami, USA.'}, {'ForeName': 'Giselle', 'Initials': 'G', 'LastName': 'Guerra', 'Affiliation': 'Miami Transplant Institute, Department of Medicine, Leonard M. Miller School of Medicine, University of Miami, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Roth', 'Affiliation': 'Miami Transplant Institute, Department of Medicine, Leonard M. Miller School of Medicine, University of Miami, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Miami Transplant Institute, Department of Medicine, Leonard M. Miller School of Medicine, University of Miami, USA.'}, {'ForeName': 'Warren', 'Initials': 'W', 'LastName': 'Kupin', 'Affiliation': 'Miami Transplant Institute, Department of Medicine, Leonard M. Miller School of Medicine, University of Miami, USA.'}, {'ForeName': 'Adela', 'Initials': 'A', 'LastName': 'Mattiazzi', 'Affiliation': 'Miami Transplant Institute, Department of Medicine, Leonard M. Miller School of Medicine, University of Miami, USA.'}, {'ForeName': 'Mariella', 'Initials': 'M', 'LastName': 'Ortigosa-Goggins', 'Affiliation': 'Miami Transplant Institute, Department of Medicine, Leonard M. Miller School of Medicine, University of Miami, USA.'}, {'ForeName': 'Lissett', 'Initials': 'L', 'LastName': 'Moni', 'Affiliation': 'Miami Transplant Institute, Department of Medicine, Leonard M. Miller School of Medicine, University of Miami, USA.'}, {'ForeName': 'George W', 'Initials': 'GW', 'LastName': 'Burke', 'Affiliation': 'Miami Transplant Institute, Department of Medicine, Leonard M. Miller School of Medicine, University of Miami, USA.'}]",Clinical transplantation,['10.1111/ctr.14123']
1435,33070419,Efficacy and safety of tafamidis doses in the Tafamidis in Transthyretin Cardiomyopathy Clinical Trial (ATTR-ACT) and long-term extension study.,"AIMS


Tafamidis is an effective treatment for transthyretin amyloid cardiomyopathy (ATTR-CM) in the Tafamidis in Transthyretin Cardiomyopathy Clinical Trial (ATTR-ACT). While ATTR-ACT was not designed for a dose-specific assessment, further analysis from ATTR-ACT and its long-term extension study (LTE) can guide determination of the optimal dose.
METHODS AND RESULTS


In ATTR-ACT, patients were randomized (2:1:2) to tafamidis 80mg, 20mg, or placebo for 30 months. Patients completing ATTR-ACT could enrol in the LTE (with placebo-treated patients randomized to tafamidis 80mg or 20mg; 2:1) and all patients were subsequently switched to high-dose tafamidis. All-cause mortality was assessed in ATTR-ACT combined with the LTE (median follow-up 51 months). In ATTR-ACT, the combination of all-cause mortality and cardiovascular-related hospitalizations over 30 months was significantly reduced with tafamidis 80mg (P =0.0030) and 20mg (P=0.0048) vs. placebo. All-cause mortality vs. placebo was reduced with tafamidis 80mg (Cox hazards model [95% CI]: 0.690 [0.487-0.979], P=0.0378) and 20mg (0.715 [0.450-1.137], P=0.1564). The mean (SE) change in NT-proBNP from baseline to Month 30 was -1170.51 (587.31), P=0.0468 with tafamidis 80mg vs. 20mg. In ATTR-ACT combined with the LTE there was a significantly greater survival benefit with tafamidis 80mg vs 20mg (0.700 [0.501-0.979], P=0.0374). Incidence of adverse events in both tafamidis doses were comparable to placebo.
CONCLUSION


Tafamidis, both 80mg and 20mg, effectively reduced mortality and cardiovascular-related hospitalizations in patients with ATTR-CM. The longer-term survival data, and the lack of dose-related safety concerns, support tafamidis 80mg as the optimal dose. This article is protected by copyright. All rights reserved.",2020,"All-cause mortality vs. placebo was reduced with tafamidis 80mg (Cox hazards model [95% CI]: 0.690 [0.487-0.979], P=0.0378) and 20mg (0.715 [0.450-1.137], P=0.1564).",['patients with ATTR-CM'],['placebo'],"['Incidence of adverse events', 'longer-term survival data', 'Efficacy and safety', 'mortality and cardiovascular-related hospitalizations', 'mean (SE) change in NT-proBNP', 'survival benefit']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032923', 'cui_str': 'Prealbumin'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}]",,0.153542,"All-cause mortality vs. placebo was reduced with tafamidis 80mg (Cox hazards model [95% CI]: 0.690 [0.487-0.979], P=0.0378) and 20mg (0.715 [0.450-1.137], P=0.1564).","[{'ForeName': 'Thibaud', 'Initials': 'T', 'LastName': 'Damy', 'Affiliation': 'French Referral Center for Cardiac Amyloidosis, Amyloidosis Mondor Network, GRC Amyloid Research Institute and Department of Cardiology, all at APHP, CHU Henri Mondor; and INSERM U955, Clinical Investigation Center 006, and DHU ATVB, all at Créteil, France.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Garcia-Pavia', 'Affiliation': 'Hospital Universitario Puerta de Hierro Majadahonda, CIBERCV, Madrid, Spain.'}, {'ForeName': 'Mazen', 'Initials': 'M', 'LastName': 'Hanna', 'Affiliation': 'Amyloidosis Centre, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Judge', 'Affiliation': 'Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Giampaolo', 'Initials': 'G', 'LastName': 'Merlini', 'Affiliation': 'Amyloidosis Center, IRCCS Policlinico San Matteo and University of Pavia, Pavia, Italy.'}, {'ForeName': 'Balarama', 'Initials': 'B', 'LastName': 'Gundapaneni', 'Affiliation': 'Pfizer, Groton, CT, USA; 8Pfizer Inc, New York, NY, USA.'}, {'ForeName': 'Terrell A', 'Initials': 'TA', 'LastName': 'Patterson', 'Affiliation': 'Pfizer, Groton, CT, USA; 8Pfizer Inc, New York, NY, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Riley', 'Affiliation': 'Pfizer, Groton, CT, USA; 8Pfizer Inc, New York, NY, USA.'}, {'ForeName': 'Jeffrey H', 'Initials': 'JH', 'LastName': 'Schwartz', 'Affiliation': ''}, {'ForeName': 'Marla B', 'Initials': 'MB', 'LastName': 'Sultan', 'Affiliation': ''}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Witteles', 'Affiliation': 'Stanford University School of Medicine, Stanford, CA, USA.'}]",European journal of heart failure,['10.1002/ejhf.2027']
1436,33070469,Comparing propofol with placebo for early resolution of acute migraine in adult emergency department patients: A double-blind randomised controlled trial.,"OBJECTIVE


To compare propofol with placebo in adult ED patients with acute migraine. Primary outcome was headache resolution by 1 h. Secondary outcome was reduction in headache severity by two or more points on a numerical rating scale.
METHODS


Double-blind randomised controlled clinical trial comparing propofol (10 mg/mL) with placebo (20% intralipid). Adults with acute migraine without aura were included. The study drug was administered as an initial dose of 4 mL followed by up to five doses of 2 mL, delivered 5 min apart. Pain scores were taken prior to each dose and further administration was ceased when either the pain score was zero or the maximum dosage reached (140 mg of propofol or 14 mL of 20% intralipid).
RESULTS


Of 40 recruited patients, 21 received propofol and 19 placebo. Headache resolution occurred for 5 (24%, 95% CI 13-57) and 6 (32%, 95% CI 13-57) patients, respectively, difference 8% (95% CI -20 to 36). Headache severity reduction by two or more numerical rating scale points was reported by 17 (81%, 95% CI 58-95) and 7 (37%, 95% CI 16-62) patients, respectively, difference 44% (95% CI 17-71).
CONCLUSIONS


Propofol was not superior to placebo for the primary outcome of early headache resolution. Superiority of propofol for the secondary outcome of headache severity reduction suggests that further research may be warranted.",2020,"Headache severity reduction by two or more numerical rating scale points was reported by 17 (81%, 95% CI 58-95) and 7 (37%, 95% CI 16-62) patients, respectively, difference 44% (95% CI 17-71).
","['Adults with acute migraine without aura were included', 'adult ED patients with acute migraine', 'Of 40 recruited patients, 21 received', 'adult emergency department patients']","['propofol with placebo', 'placebo (20% intralipid', 'propofol', 'placebo', 'propofol or 14\u2009mL of 20% intralipid', 'Propofol']","['headache resolution', 'numerical rating scale points', 'Pain scores', 'numerical rating scale', 'headache severity', 'pain score', 'Headache resolution', 'Headache severity reduction', 'early headache resolution']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1740836', 'cui_str': 'Acute migraine'}, {'cui': 'C0236018', 'cui_str': 'Aura'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0733854', 'cui_str': 'Intralipid'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1279919', 'cui_str': 'Early'}]",40.0,0.759168,"Headache severity reduction by two or more numerical rating scale points was reported by 17 (81%, 95% CI 58-95) and 7 (37%, 95% CI 16-62) patients, respectively, difference 44% (95% CI 17-71).
","[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Meek', 'Affiliation': 'Emergency Department, Dandenong Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Andis', 'Initials': 'A', 'LastName': 'Graudins', 'Affiliation': 'Emergency Department, Dandenong Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Micah', 'Initials': 'M', 'LastName': 'McDonald', 'Affiliation': 'Emergency Department, Dandenong Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'McGannon', 'Affiliation': 'Emergency Department, Dandenong Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Ezra', 'Initials': 'E', 'LastName': 'Limm', 'Affiliation': 'Emergency Department, Dandenong Hospital, Melbourne, Victoria, Australia.'}]",Emergency medicine Australasia : EMA,['10.1111/1742-6723.13659']
1437,33070517,Attentional and neurophysiologic effects of repetitive transcranial magnetic stimulation.,"Twenty-seven healthy subjects were randomly assigned to 1 of 2 equal groups : (1) experimental group (active stimulation) and (2) control group (sham stimulation). A total of 10 Hz repetitive transcranial magnetic stimulation was delivered to the left dorsolateral prefrontal cortex at 80% of the resting motor threshold. The reaction time of the correct response, omission error, and commission error of the auditory and visual continuous performance test scores were measured. The motor evoked potentials, resting motor threshold, short-interval intracortical inhibition, and intracortical facilitation was recorded in the right first dorsal interosseous muscle to determine motor cortex excitability. The reaction time and commission error of the auditory continuous performance test were reduced significantly after 10 Hz repetitive transcranial magnetic stimulation ( P  < 0.05). Resting motor threshold and short-interval intracortical inhibition was significantly decreased after active repetitive transcranial magnetic stimulation ( P  < 0.05), with no changes in the latency and amplitude of the motor evoked potentials and intracortical facilitation. In conclusion, high-frequency repetitive transcranial magnetic stimulation to the left dorsolateral prefrontal cortex is shown to improve the attentional function and may be simultaneously associated with changes in neurophysiological activity.",2020,The reaction time and commission error of the auditory continuous performance test were reduced significantly after 10 Hz repetitive transcranial magnetic stimulation ( P  < 0.05).,['Twenty-seven healthy subjects'],"['10 Hz repetitive transcranial magnetic stimulation', 'repetitive transcranial magnetic stimulation', 'experimental group (active stimulation) and (2) control group (sham stimulation']","['reaction time and commission error of the auditory continuous performance test', 'latency and amplitude of the motor evoked potentials and intracortical facilitation', 'reaction time of the correct response, omission error, and commission error of the auditory and visual continuous performance test scores', 'Resting motor threshold and short-interval intracortical inhibition', 'motor evoked potentials, resting motor threshold, short-interval intracortical inhibition, and intracortical facilitation', 'attentional function']","[{'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0282617', 'cui_str': 'Motor Evoked Potentials'}, {'cui': 'C0037415', 'cui_str': 'Social Facilitation'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",,0.0390494,The reaction time and commission error of the auditory continuous performance test were reduced significantly after 10 Hz repetitive transcranial magnetic stimulation ( P  < 0.05).,"[{'ForeName': 'Yeong-Wook', 'Initials': 'YW', 'LastName': 'Kim', 'Affiliation': 'Department of Rehabilitation Medicine, Chungnam National University Hospital, Daejeon, 35015, Republic of Korea.'}, {'ForeName': 'Juan-Xiu', 'Initials': 'JX', 'LastName': 'Cui', 'Affiliation': 'Department of Rehabilitation Medicine, School of Medicine, Chungnam National University, Daejeon, 35015, Republic of Korea.'}, {'ForeName': 'Sheng-Lan', 'Initials': 'SL', 'LastName': 'Jin', 'Affiliation': 'Department of Rehabilitation Medicine, Yanbian University Hospital, Yanji, 133001, P. R. China.'}, {'ForeName': 'Sung-Ju', 'Initials': 'SJ', 'LastName': 'Jee', 'Affiliation': 'Department of Rehabilitation Medicine, Chungnam National University Hospital, Daejeon, 35015, Republic of Korea.'}, {'ForeName': 'Min-Kyun', 'Initials': 'MK', 'LastName': 'Sohn', 'Affiliation': 'Department of Rehabilitation Medicine, Chungnam National University Hospital, Daejeon, 35015, Republic of Korea.'}]",Journal of integrative neuroscience,['10.31083/j.jin.2020.03.134']
1438,33070582,Endotracheal intubation in patients undergoing open abdominal surgery in the lateral position: a comparison between intubating video stylet and fiberoptic intubating bronchoscopy.,"Background


We compared elective endotracheal intubation in lateral decubitus position using a video stylet device with fiberoptic bronchoscope device in patients undergoing laparotomy abdominal surgery.
Methods


Overall, 50 patients were enrolled in this prospective, randomised study. They were randomly classified into either video stylet (VS) intubation group or fiberoptic (FO) intubating bronchoscope group. After anaesthesia induction, patients were placed in lateral decubitus position, and a single investigator well versed in the use of the VS and FO bronchoscope performed the intubation. The primary outcome was the time taken for intubation. Secondary outcomes included intubation success rate, hemodynamic response at specific time points, overall user satisfaction and perioperative complications.
Results


The average time taken for intubation was significantly lower in the VS group than that in the FO group, with values of 39.5 ± 10 and 75.6 ± 16.2 s, respectively (P < 0.001). Incidence of successful first attempt intubation in the VS group was 88% vs. 100% in the FO group, which was statistically not different. There was a negligible difference in complications between the groups except sore throat, which showed a higher incidence in the VS group than that in the FO group (P = 0.013).
Conclusions


In laterally positioned patients, elective endotracheal intubation with VS provides less intubation time and incidence of success rate for a single intubation trial [88%]; however, its use is accompanied by a significant increase in hemodynamic response after intubation and an increased incidence of sore throat.",2020,"There was a negligible difference in complications between the groups except sore throat, which showed a higher incidence in the VS group than that in the FO group (P = 0.013).
","['50 patients', 'patients undergoing open abdominal surgery in the lateral position', 'patients undergoing laparotomy abdominal surgery']","['intubating video stylet and fiberoptic intubating bronchoscopy', 'video stylet device with fiberoptic bronchoscope device', 'elective endotracheal intubation', 'Endotracheal intubation', 'video stylet (VS) intubation group or fiberoptic (FO) intubating bronchoscope group']","['intubation success rate, hemodynamic response at specific time points, overall user satisfaction and perioperative complications', 'time taken for intubation', 'intubation time and incidence of success rate', 'Incidence of successful first attempt intubation', 'average time taken for intubation', 'complications', 'hemodynamic response']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}, {'cui': 'C0444379', 'cui_str': 'Lateral decubitus position'}, {'cui': 'C0023038', 'cui_str': 'Laparotomy'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0183663', 'cui_str': 'Stylet'}, {'cui': 'C0006290', 'cui_str': 'Bronchoscopy'}, {'cui': 'C0179433', 'cui_str': 'Flexible bronchoscope'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0179432', 'cui_str': 'Bronchoscope'}]","[{'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C4545429', 'cui_str': 'Perioperative complication'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",50.0,0.137646,"There was a negligible difference in complications between the groups except sore throat, which showed a higher incidence in the VS group than that in the FO group (P = 0.013).
","[{'ForeName': 'Amr Samir', 'Initials': 'AS', 'LastName': 'Wahdan', 'Affiliation': 'Department of Anaesthesia, Surgical ICU and Pain Management, Faculty of medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Nesrine Abdel Rahman', 'Initials': 'NAR', 'LastName': 'Elrefai', 'Affiliation': 'Department of Anaesthesia, Surgical ICU and Pain Management, Faculty of medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Sohaila Hussien', 'Initials': 'SH', 'LastName': 'Omar', 'Affiliation': 'Department: of Anaesthesia, surgical ICU &Pain management, Theodor Bilharz Research Institute, Cairo, Egypt.'}, {'ForeName': 'Shady Amr', 'Initials': 'SA', 'LastName': 'Abdel Moneem', 'Affiliation': 'Department: of Anaesthesia, surgical ICU &Pain management, Theodor Bilharz Research Institute, Cairo, Egypt.'}, {'ForeName': 'Mennatallah Magdi', 'Initials': 'MM', 'LastName': 'Mohamed', 'Affiliation': 'Department of Anaesthesia, Surgical ICU and Pain Management, Faculty of medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Mohamed Mahmoud', 'Initials': 'MM', 'LastName': 'Hussien', 'Affiliation': 'Department: of Anaesthesia, surgical ICU &Pain management, Theodor Bilharz Research Institute, Cairo, Egypt.'}]",Korean journal of anesthesiology,['10.4097/kja.20384']
1439,33070649,A split-face comparative trial of photopneumatic therapy versus intense pulsed light for the treatment of acne vulgaris.,"A novel photopneumatic (PPX) technology, combining blue light-emitting diode (LED) and broadband intense pulsed light (IPL) with vacuum pressure, was developed for the treatment of acne vulgaris (AV). In this study, we enrolled 50 patients with mild to moderate AV. Five successive treatments were performed on one side of the face with a combined PPX device, and the opposite side was treated with only IPL with the same fluences at 2-week intervals. Clinical improvement was evaluated by inflammatory and non-inflammatory acne lesion counts. Additionally, patient self-assessment scores were assessed. The results showed that inflammatory and non-inflammatory acne lesion counts were significantly improved on both sides of the face after treatment ( p  < .001,  p  = .001, respectively). Both inflammatory and non-inflammatory lesion counts were significantly reduced on the side treated with PPX when compared to the side treated with IPL alone ( p  = .008,  p  = .045, respectively). Thirty-eight of 44 patients reported slight to moderate improvement on the patient self-assessment score. No significant side effect was observed during the study periods.In conclusion, PPX therapy is an effective and safe modality to treat mild to moderate AV. This study shows that PPX therapy has superior efficacy for the treatment of AV compared to IPL monotherapy.",2020,"Both inflammatory and non-inflammatory lesion counts were significantly reduced on the side treated with PPX when compared to the side treated with IPL alone ( p  = .008,  p  = .045, respectively).","['acne vulgaris', '50 patients with mild to moderate AV']","['photopneumatic therapy versus intense pulsed light', 'novel photopneumatic (PPX) technology, combining blue light-emitting diode (LED) and broadband intense pulsed light (IPL) with vacuum pressure', 'PPX therapy', 'IPL', 'PPX']","['Both inflammatory and non-inflammatory lesion counts', 'patient self-assessment scores', 'side effect', 'patient self-assessment score', 'inflammatory and non-inflammatory acne lesion counts']","[{'cui': 'C0001144', 'cui_str': 'Acne vulgaris'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0303896', 'cui_str': 'Blue light'}, {'cui': 'C0162676', 'cui_str': 'Enzyme-multiplied immunoassay technique'}, {'cui': 'C0042221', 'cui_str': 'Vacuum'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C1565646', 'cui_str': 'Propoxure'}]","[{'cui': 'C3872830', 'cui_str': 'Inflammatory lesion'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036591', 'cui_str': 'Self Assessment'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C1998083', 'cui_str': 'Inflammatory acne'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]",50.0,0.0130506,"Both inflammatory and non-inflammatory lesion counts were significantly reduced on the side treated with PPX when compared to the side treated with IPL alone ( p  = .008,  p  = .045, respectively).","[{'ForeName': 'Jeong Eun', 'Initials': 'JE', 'LastName': 'Kim', 'Affiliation': 'Department of Dermatology, Hanyang University College of Medicine , Seoul, Republic of Korea.'}, {'ForeName': 'Byeong Jin', 'Initials': 'BJ', 'LastName': 'Park', 'Affiliation': 'Department of Dermatology, Hanyang University College of Medicine , Seoul, Republic of Korea.'}, {'ForeName': 'Seo Rye', 'Initials': 'SR', 'LastName': 'Yu', 'Affiliation': 'Department of Dermatology, Lee Ji Ham Dermatologic Clinic , Seoul, Korea.'}, {'ForeName': 'Young Hoon', 'Initials': 'YH', 'LastName': 'Kim', 'Affiliation': 'Department of Dermatology, Lee Ji Ham Dermatologic Clinic , Seoul, Korea.'}, {'ForeName': 'Young Suck', 'Initials': 'YS', 'LastName': 'Ro', 'Affiliation': 'Department of Dermatology, Hanyang University College of Medicine , Seoul, Republic of Korea.'}, {'ForeName': 'Joo Yeon', 'Initials': 'JY', 'LastName': 'Ko', 'Affiliation': 'Department of Dermatology, Hanyang University College of Medicine , Seoul, Republic of Korea.'}]",Journal of cosmetic and laser therapy : official publication of the European Society for Laser Dermatology,['10.1080/14764172.2020.1827149']
1440,33070667,A randomized controlled trial of cognitive behavioral therapy compared with diabetes education for diabetic peripheral neuropathic pain.,"A randomized controlled trial compared cognitive behavioral therapy (CBT) and diabetes education (ED) as an adjunctive treatment for diabetic peripheral neuropathic pain (DPNP). We examined change from baseline to 12- and 36-week follow-up in overall pain intensity (NRS), neuropathic pain intensity/quality, pain interference, and mental health functioning, among others. Although CBT participants demonstrated improvement in pain intensity NRS, there were no between-condition differences at either follow-up. CBT reduced neuropathic pain intensity at 12-weeks more than ED. At 36-weeks, CBT was superior to ED for improving pain interference and mental health functioning. Results provide evidence of benefit of CBT for DPNP. ClinicalTrials.gov Identifier : NCT00830011.",2020,"Although CBT participants demonstrated improvement in pain intensity NRS, there were no between-condition differences at either follow-up.","['diabetic peripheral neuropathic pain (DPNP', 'diabetic peripheral neuropathic pain']","['CBT', 'diabetes education', 'cognitive behavioral therapy (CBT) and diabetes education (ED', 'cognitive behavioral therapy']","['overall pain intensity (NRS), neuropathic pain intensity/quality, pain interference, and mental health functioning', 'pain intensity NRS', 'pain interference and mental health functioning', 'neuropathic pain intensity']","[{'cui': 'C1963916', 'cui_str': 'Diabetic peripheral neuropathic pain'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0027796', 'cui_str': 'Neuralgia'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]",,0.216478,"Although CBT participants demonstrated improvement in pain intensity NRS, there were no between-condition differences at either follow-up.","[{'ForeName': 'Diana M', 'Initials': 'DM', 'LastName': 'Higgins', 'Affiliation': 'VA Boston Healthcare System, Boston, MA, USA.'}, {'ForeName': 'Alicia A', 'Initials': 'AA', 'LastName': 'Heapy', 'Affiliation': 'VA Connecticut Healthcare System, West Haven, CT, USA.'}, {'ForeName': 'Eugenia', 'Initials': 'E', 'LastName': 'Buta', 'Affiliation': 'Yale School of Public Health, New Haven, CT, USA.'}, {'ForeName': 'Kathryn M', 'Initials': 'KM', 'LastName': 'LaChappelle', 'Affiliation': 'VA Connecticut Healthcare System, West Haven, CT, USA.'}, {'ForeName': 'Kristin L', 'Initials': 'KL', 'LastName': 'Serowik', 'Affiliation': 'VA Connecticut Healthcare System, West Haven, CT, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Czlapinski', 'Affiliation': 'VA Connecticut Healthcare System, West Haven, CT, USA.'}, {'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'Kerns', 'Affiliation': 'VA Connecticut Healthcare System, West Haven, CT, USA.'}]",Journal of health psychology,['10.1177/1359105320962262']
1441,33070698,Acute effect of resistance exercise on cognitive function in people living with HIV.,"People living with HIV are at an increased risk of developing cognitive deficits. Physical exercise is an important strategy to improve the brain health of people living with HIV. This randomized, controlled study aimed to investigate the acute effect of a single resistance exercise session on the cognitive function of people living with HIV. Twenty-three people living with HIV were randomized (1:1) to a control group (n = 12) or the exercise group (n = 11). Cognitive function was assessed by the Stroop test and the Trail Making Test. The exercise group was evaluated before and after the exercise session; meanwhile, the control group was evaluated before and after a 40-minute rest period. No statistical difference was found on the effect of exercise on cognitive function ( p  > 0.05). This result suggests that one session of resistance exercise was not capable of improving the cognitive function of people with HIV.",2020,No statistical difference was found on the effect of exercise on cognitive function ( p  > 0.05).,"['Twenty-three people living with HIV', 'people with HIV', 'People living with HIV', 'people living with HIV']","['single resistance exercise session', 'Physical exercise', 'resistance exercise']","['Cognitive function', 'cognitive function']","[{'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",23.0,0.0426023,No statistical difference was found on the effect of exercise on cognitive function ( p  > 0.05).,"[{'ForeName': 'Dayane C', 'Initials': 'DC', 'LastName': 'de Souza', 'Affiliation': 'Department of Physical Education, Western State University of Parana, Marechal Cândido Rondon, Brazil.'}, {'ForeName': 'Wagner Jr', 'Initials': 'WJ', 'LastName': 'Domingues', 'Affiliation': 'Collegiate of Physical Education, Institute of Social Sciences, Education and Zootechnics, Federal University of Amazonas, Parintins, Brazil.'}, {'ForeName': 'Kauana B', 'Initials': 'KB', 'LastName': 'Marchini', 'Affiliation': 'Department of Physical Education, State University of Maringa, Maringa, Brazil.'}, {'ForeName': 'Pollyana M', 'Initials': 'PM', 'LastName': 'Nunhes', 'Affiliation': 'Department of Physical Education, State University of Maringa, Maringa, Brazil.'}, {'ForeName': 'Alesandro', 'Initials': 'A', 'LastName': 'Garcia', 'Affiliation': 'Maringá University Center, Maringa, Brazil.'}, {'ForeName': 'Lucas F', 'Initials': 'LF', 'LastName': 'Hey', 'Affiliation': 'Department of Physical Education, State University of Maringa, Maringa, Brazil.'}, {'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Ardengue', 'Affiliation': 'Department of Physical Education, State University of Maringa, Maringa, Brazil.'}, {'ForeName': 'Isabela', 'Initials': 'I', 'LastName': 'Pasinato', 'Affiliation': 'Department of Physical Education, State University of Maringa, Maringa, Brazil.'}, {'ForeName': 'Ademar', 'Initials': 'A', 'LastName': 'Avelar', 'Affiliation': 'Department of Physical Education, State University of Maringa, Maringa, Brazil.'}]",International journal of STD & AIDS,['10.1177/0956462420958578']
1442,33070770,Prenatal Administration of Betamethasone and Neonatal Respiratory Distress Syndrome in Multifetal Pregnancies: A Randomized Controlled Trial.,"BACKGROUND


Neonatal Respiratory Distress Syndrome (NRDS) is one of the most frequent causes of neonatal mortality especially in premature infants. Although it has been well established that maternal antenatal corticosteroid therapy has a positive effect on NRDS reduction, yet the effectiveness of this treatment in multifetal pregnancies is dubious.
OBJECTIVE


We aimed to investigate the effect of betamethasone therapy on the incidence of NRDS in multifetal pregnancies through a randomized controlled trial.
METHODS


140 women with a multifetal pregnancy at less than 28 weeks' gestational age were randomly allocated into intervention and control groups. Women at the intervention group received intramuscularly betamethasone (12 mg/kg/BW twice). Neonatal outcomes were evaluated between two groups of intervention and control, and two subgroups of preterm and term births. This study is registered with the Iranian Clinical Trials Registry, number IRCT20180227038879N1.
RESULTS


The incidence of NRDS was significantly lower in infants of betamethasone group than the ones in the control group (4.9% vs 18.1%, P=0.034) while it did not show a significant reduction in preterm infants compared to mature ones. Also, the intervention group presented a significant lower neonatal ventilation than the control group (47.2% vs 63.2%, P=0.041). Other neonatal outcomes, including age at birth, birth weight, Apgar score, NICU admission, and the number of mortalities were not significantly different between study groups.
CONCLUSION


Betamethasone therapy during 28-32 weeks of gestation in multifetal pregnancies was associated with better neonatal outcomes through significant reductions in NRDS incidence and requiring ventilator treatment. However, betamethasone administration did not reduce the chance of NRDS in premature infants.",2020,"The incidence of NRDS was significantly lower in infants of betamethasone group than the ones in the control group (4.9% vs 18.1%, P=0.034) while it did not show a significant reduction in preterm infants compared to mature ones.","['premature infants', 'multifetal pregnancies', ""140 women with a multifetal pregnancy at less than 28 weeks' gestational age"", 'Neonatal Respiratory Distress Syndrome (NRDS', 'Multifetal Pregnancies']","['betamethasone therapy', 'Betamethasone', 'intramuscularly betamethasone', 'betamethasone']","['incidence of NRDS', 'neonatal ventilation', 'chance of NRDS', 'age at birth, birth weight, Apgar score, NICU admission, and the number of mortalities']","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0035220', 'cui_str': 'Respiratory distress syndrome in the newborn'}]","[{'cui': 'C0005308', 'cui_str': 'Betamethasone'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0035220', 'cui_str': 'Respiratory distress syndrome in the newborn'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1744681', 'cui_str': 'Congenital'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0003533', 'cui_str': 'Finding of Apgar score'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",140.0,0.138976,"The incidence of NRDS was significantly lower in infants of betamethasone group than the ones in the control group (4.9% vs 18.1%, P=0.034) while it did not show a significant reduction in preterm infants compared to mature ones.","[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Abbasalizadeh', 'Affiliation': ""Department of Obstetrics and Gynecology, School of Medicine, Women's Reproductive Health Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.""}, {'ForeName': 'Khadijeh', 'Initials': 'K', 'LastName': 'Pouya', 'Affiliation': 'Department of Obstetrics and Gynecology, Ankara University School of Medicine, Ankara, Turkey.'}, {'ForeName': 'Raana', 'Initials': 'R', 'LastName': 'Zakeri', 'Affiliation': 'Department of Health Services Management, School of Management and Medical Informatics, Iranian International Safe Community Support Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Rana', 'Initials': 'R', 'LastName': 'Asgari-Arbat', 'Affiliation': ""Department of Obstetrics and Gynecology, School of Medicine, Women's Reproductive Health Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.""}, {'ForeName': 'Shamsi', 'Initials': 'S', 'LastName': 'Abbasalizadeh', 'Affiliation': ""Department of Obstetrics and Gynecology, School of Medicine, Women's Reproductive Health Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.""}, {'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'Parnianfard', 'Affiliation': 'Research Center for Evidence-Based Medicine, Drug Applied Research Center, Health Management and Safety Promotion Research Institute, Tabriz University of Medical Sciences, Tabriz, Iran.'}]",Current clinical pharmacology,['10.2174/1574884714666191007154936']
1443,33070796,Effect of acute citalopram on self-referential emotional processing and social cognition in healthy volunteers.,"BACKGROUND


Depression is characterised by negative views of the self. Antidepressant treatment may remediate negative self-schema through increasing processing of positive information about the self. Changes in affective processing during social interactions may increase expression of prosocial behaviours, improving interpersonal communications.
AIMS


To examine whether acute administration of citalopram is associated with an increase in positive affective learning biases about the self and prosocial behaviour.
METHOD


Healthy volunteers (n = 41) were randomised to either an acute 20 mg dose of citalopram or matched placebo in a between-subjects double-blind design. Participants completed computer-based cognitive tasks designed to measure referential affective processing, social cognition and expression of prosocial behaviours.
RESULTS


Participants administered citalopram made more cooperative choices than those administered placebo in a prisoner's dilemma task (β = 20%, 95% CI: 2%, 37%). Exploratory analyses indicated that participants administered citalopram showed a positive bias when learning social evaluations about a friend (β = 4.06, 95% CI: 0.88, 7.24), but not about the self or a stranger. Similarly, exploratory analyses found evidence of increased recall of positive words and reduced recall of negative words about others (β = 2.41, 95% CI: 0.89, 3.93), but not the self, in the citalopram group.
CONCLUSIONS


Participants administered citalopram showed greater prosocial behaviours, increased positive recall and increased positive learning of social evaluations towards others. The increase in positive affective bias and prosocial behaviours towards others may, at least partially, be a mechanism of antidepressant effect. However, we found no evidence that citalopram influenced self-referential processing.",2020,"RESULTS


Participants administered citalopram made more cooperative choices than those administered placebo in a prisoner's dilemma task (β = 20%, 95% CI: 2%, 37%).","['healthy volunteers', 'Healthy volunteers (n = 41']","['acute citalopram', 'citalopram', 'placebo', 'acute 20 mg dose of citalopram or matched placebo']","['learning social evaluations', 'positive affective bias and prosocial behaviours', 'positive recall and increased positive learning of social evaluations', 'self-referential emotional processing and social cognition', 'positive affective learning biases', 'cooperative choices', 'recall of positive words and reduced recall of negative words', 'self-referential processing', 'prosocial behaviours', 'referential affective processing, social cognition and expression of prosocial behaviours']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0008845', 'cui_str': 'Citalopram'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0679082', 'cui_str': 'Social Learning'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}]",41.0,0.184854,"RESULTS


Participants administered citalopram made more cooperative choices than those administered placebo in a prisoner's dilemma task (β = 20%, 95% CI: 2%, 37%).","[{'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Hobbs', 'Affiliation': 'Department of Psychology, University of Bath, UK.'}, {'ForeName': 'Susannah E', 'Initials': 'SE', 'LastName': 'Murphy', 'Affiliation': 'Department of Psychiatry, University of Oxford, and NHS Foundation Trust, Warneford Hospital, Oxford, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Wright', 'Affiliation': 'Department of Psychiatry, University of Oxford, and NHS Foundation Trust, Warneford Hospital, Oxford, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Carson', 'Affiliation': 'Department of Psychiatry, University of Oxford, and NHS Foundation Trust, Warneford Hospital, Oxford, UK.'}, {'ForeName': 'Indra Van', 'Initials': 'IV', 'LastName': 'Assche', 'Affiliation': 'Department of Psychiatry, University of Oxford, and NHS Foundation Trust, Warneford Hospital, Oxford, UK.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': ""O'Brien"", 'Affiliation': 'Department of Psychiatry, University of Oxford, and NHS Foundation Trust, Warneford Hospital, Oxford, UK.'}, {'ForeName': 'Mayowa', 'Initials': 'M', 'LastName': 'Oyesanya', 'Affiliation': 'Department of Psychiatry, University of Oxford, and NHS Foundation Trust, Warneford Hospital, Oxford, UK.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Sui', 'Affiliation': 'School of Psychology, University of Aberdeen, UK.'}, {'ForeName': 'Marcus R', 'Initials': 'MR', 'LastName': 'Munafò', 'Affiliation': 'School of Psychological Science, University of Bristol, MRC Integrative Epidemiology Unit at the University of Bristol, and National Institute of Health Research Biomedical Research Centre at the University Hospitals Bristol NHS Foundation Trust and the University of Bristol, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kessler', 'Affiliation': 'Population Health Sciences, University of Bristol.'}, {'ForeName': 'Catherine J', 'Initials': 'CJ', 'LastName': 'Harmer', 'Affiliation': 'Department of Psychiatry, University of Oxford, and NHS Foundation Trust, Warneford Hospital, Oxford, UK.'}, {'ForeName': 'Katherine S', 'Initials': 'KS', 'LastName': 'Button', 'Affiliation': 'Department of Psychology, University of Bath, UK.'}]",BJPsych open,['10.1192/bjo.2020.107']
1444,33070818,[Evaluation of effects of salt reducing intervention among catering units in Shandong Province].,"OBJECTIVE


To evaluate the effects of comprehensive intervention measures mainly consisting of salt reduction health education and labeling less salt foods among catering units.
METHODS


The total of 36 catering units were selected randomly and divided into intervention group A, B and control group in August of 2015. Health education was initiated in the intervention group A, including the training of knowledge on salt reduction for managers, cooks and service personnel of catering units every month; distribution of special salt control spoon for cooks; the arrangement of environment of salt reduction in catering units. And health education and labeling less salt foods was provided to the intervention group B, The control group C did not actively provide any intervention. The cook records the quantity of low-salt dishes sold, salt collection and the number of persons per meal in according to the requirements. Questionnaire survey and physical examination were performed to evaluate the effects of comprehensive intervention measures among catering units in the three groups of staffs in the catering units in a baseline study and an evaluation survey six months after the intervention.
RESULTS


Compared with group C, the knowledge, attitude and behavior of salt reduction was significantly improved in intervention group A and B(P&lt;0. 05). The behavior towards salt reduction improved much better in group B than in group A(P&lt;0. 05), and using salt spoon when cooking and recommending less salt food to customer improved 32. 1%(χ~2=51. 72, P&lt;0. 05)and 24. 2%(χ~2=30. 01, P&lt;0. 05)separately. The proportion of sales of low salt dishes in the unit canteen has increased steadily, reaching 16. 8% while the proportion of sales has dropped to 9. 2% in the hotel by the end of the intervention period(χ~2=44. 66, P&lt;0. 05).
CONCLUSION


The level of knowledge of reducing salt was improved by health education, and labeling less salt foods can promote reducing salt related behavior. The effect of comprehensive intervention measures for salt reduction in unit canteen is better than in the hotel. It was suggested that comprehensive intervention measures mainly consisting of salt reduction health education and labeling less salt foods should be used together in the catering units.",2020,"Compared with group C, the knowledge, attitude and behavior of salt reduction was significantly improved in intervention group A and B(P&lt;0.","['catering units in the three groups of staffs in the catering units in a baseline study and an evaluation survey six months after the intervention', '36 catering units', 'catering units in Shandong Province']","['training of knowledge on salt reduction for managers, cooks and service personnel of catering units every month; distribution of special salt control spoon', 'comprehensive intervention measures', 'salt reducing intervention']","['behavior towards salt reduction', 'knowledge, attitude and behavior of salt reduction', 'level of knowledge of reducing salt']","[{'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0335141', 'cui_str': 'Manager'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0581226', 'cui_str': 'Spoon'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]",,0.0122607,"Compared with group C, the knowledge, attitude and behavior of salt reduction was significantly improved in intervention group A and B(P&lt;0.","[{'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Ren', 'Affiliation': 'Department of Non-Communicable Disease Prevention, Shandong Province Center for Disease Control and Prevention, Jinan 250014, China.'}, {'ForeName': 'Xianxian', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Non-Communicable Disease Prevention, Shandong Province Center for Disease Control and Prevention, Jinan 250014, China.'}, {'ForeName': 'Jianwei', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'National Center for Chronic and Non-Communicable Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing 102206, China.'}, {'ForeName': 'Congcong', 'Initials': 'C', 'LastName': 'Gao', 'Affiliation': 'Department of Non-Communicable Disease Prevention, Shandong Province Center for Disease Control and Prevention, Jinan 250014, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Dong', 'Affiliation': 'Department of Non-Communicable Disease Prevention, Shandong Province Center for Disease Control and Prevention, Jinan 250014, China.'}, {'ForeName': 'Chunxiao', 'Initials': 'C', 'LastName': 'Xu', 'Affiliation': 'Department of Non-Communicable Disease Prevention, Shandong Province Center for Disease Control and Prevention, Jinan 250014, China.'}, {'ForeName': 'Jixiang', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'National Center for Chronic and Non-Communicable Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing 102206, China.'}, {'ForeName': 'Xiaolei', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': 'Department of Non-Communicable Disease Prevention, Shandong Province Center for Disease Control and Prevention, Jinan 250014, China.'}]",Wei sheng yan jiu = Journal of hygiene research,['10.19813/j.cnki.weishengyanjiu.2020.05.009']
1445,33070885,"Corrigendum to ""Effects of handwriting exercise on functional outcome in Parkinson disease: A randomized controlled trial"" [J Clin Neurosci 72C (2020) 298-303].",,2020,,['Parkinson disease'],['handwriting exercise'],[],"[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}]","[{'cui': 'C0018582', 'cui_str': 'Handwriting'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",[],,0.100355,,"[{'ForeName': 'Nisa', 'Initials': 'N', 'LastName': 'Vorasoot', 'Affiliation': 'Division of Neurology, Department of Medicine, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Pichet', 'Initials': 'P', 'LastName': 'Termsarasab', 'Affiliation': 'Division of Neurology, Department of Medicine, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Kunlawat', 'Initials': 'K', 'LastName': 'Thadanipon', 'Affiliation': 'Section for Clinical Epidemiology and Biostatistics, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Teeratorn', 'Initials': 'T', 'LastName': 'Pulkes', 'Affiliation': 'Division of Neurology, Department of Medicine, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand. Electronic address: teeratorn.pul@mahidol.ac.th.'}]",Journal of clinical neuroscience : official journal of the Neurosurgical Society of Australasia,['10.1016/j.jocn.2020.07.002']
1446,33071012,"Anthocyanins attenuate vascular and inflammatory responses to a high fat high energy meal challenge in overweight older adults: A cross-over, randomized, double-blind clinical trial.","BACKGROUND & AIMS


Postprandial metabolic imbalances are important indicators of later developing cardiovascular disease (CVD). This study investigated the effects of food anthocyanins on vascular and microvascular function, and CVD associated biomarkers following a high fat high energy (HFHE) meal challenge in overweight older adults.
METHODS


Sixteen subjects (13 female, 3 male, mean age 65.9 SD 6.0 and body mass index 30.6 kg/m 2  SD 3.9) participated in a crossover, randomized, controlled, double-blind clinical trial (registered under Australian New Zealand Clinical Trials Registry, identifier no. ACTRN12620000437965). Participants consumed a HFHE meal with a 250 mL dose of either intervention (anthocyanins-rich Queen Garnet Plum) or control (apricot) juice. Blood samples and blood pressure measures were collected at baseline, 2 h and 4 h following the HFHE meal. Vascular and microvascular function were evaluated at baseline and 2 h after the HFHE meal.
RESULTS


Participants had a higher 2 h postprandial flow-mediated dilatation (+1.14%) and a higher microvascular post-occlusive reactive hyperaemia (+0.10 perfusion units per mmHg) when allocated to the anthocyanin compared to the control arm (P = 0.019 and P = 0.049, respectively). C-reactive protein was lower 4 h postprandially in the anthocyanins (1.80 mg/L, IQR 0.90) vs control arm (2.30 mg/L, IQR 1.95) (P = 0.026), accompanied by a trend for lower concentrations of interleukin-6 (P = 0.075). No significant postprandial differences were observed between treatments for blood pressure, triacylglycerol, total cholesterol, serum derivatives of reactive oxidative metabolites, tumor necrosis factor alpha, interleukin-1 beta, or maximum microvascular perfusion following iontophoresis of acetylcholine.
CONCLUSION


Fruit-based anthocyanins attenuated the potential postprandial detrimental effects of a HFHE challenge on parameters of vascular and microvascular function, and inflammatory biomarkers in overweight older adults. Anthocyanins may reduce cardiovascular risk associated with endothelial dysfunction and inflammatory responses to a typical high fat 'Western' meal. Further studies are required to better elucidate the clinical implications of postprandial biomarkers of CVD.",2020,"C-reactive protein was lower 4 h postprandially in the anthocyanins (1.80 mg/L, IQR 0.90) vs control arm (2.30 mg/L, IQR 1.95)","['Sixteen subjects (13 female, 3 male, mean age 65.9 SD 6.0 and body mass index 30.6\xa0kg/m 2  SD 3.9', 'overweight older adults']","['food anthocyanins', 'HFHE meal', 'Anthocyanins', 'Fruit-based anthocyanins', 'intervention (anthocyanins-rich Queen Garnet Plum) or control (apricot) juice']","['C-reactive protein', 'vascular and microvascular function, and inflammatory biomarkers', 'higher 2\xa0h postprandial flow-mediated dilatation', 'microvascular post-occlusive reactive hyperaemia', 'blood pressure, triacylglycerol, total cholesterol, serum derivatives of reactive oxidative metabolites, tumor necrosis factor alpha, interleukin-1 beta, or maximum microvascular perfusion', 'Blood samples and blood pressure measures', 'Vascular and microvascular function']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517698', 'cui_str': '3.9'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0003161', 'cui_str': 'Anthocyanin'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0330660', 'cui_str': 'Prunus domestica'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1268568', 'cui_str': 'Juice'}]","[{'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0002940', 'cui_str': 'Aneurysm'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C1947917', 'cui_str': 'Occluded'}, {'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0020452', 'cui_str': 'Hyperemia'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0243072', 'cui_str': 'derivatives'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0021753', 'cui_str': 'interleukin-1, beta'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",,0.405399,"C-reactive protein was lower 4 h postprandially in the anthocyanins (1.80 mg/L, IQR 0.90) vs control arm (2.30 mg/L, IQR 1.95)","[{'ForeName': 'Vinicius A', 'Initials': 'VA', 'LastName': 'do Rosario', 'Affiliation': 'School of Medicine, Faculty of Science, Medicine and Health, University of Wollongong, Wollongong, NSW, 2522, Australia. Electronic address: vadr998@uowmail.edu.au.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Chang', 'Affiliation': 'School of Medicine, Faculty of Science, Medicine and Health, University of Wollongong, Wollongong, NSW, 2522, Australia; Illawarra Health & Medical Research Institute, Wollongong, NSW, 2522, Australia. Electronic address: cchang@uow.edu.au.'}, {'ForeName': 'Jaclyn', 'Initials': 'J', 'LastName': 'Spencer', 'Affiliation': 'School of Medicine, Faculty of Science, Medicine and Health, University of Wollongong, Wollongong, NSW, 2522, Australia. Electronic address: jes647@uowmail.edu.au.'}, {'ForeName': 'Thilani', 'Initials': 'T', 'LastName': 'Alahakone', 'Affiliation': 'School of Medicine, Faculty of Science, Medicine and Health, University of Wollongong, Wollongong, NSW, 2522, Australia. Electronic address: tsa598@uowmail.edu.au.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Roodenrys', 'Affiliation': 'School of Medicine, Faculty of Science, Medicine and Health, University of Wollongong, Wollongong, NSW, 2522, Australia. Electronic address: steven@uow.edu.au.'}, {'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'Francois', 'Affiliation': 'School of Medicine, Faculty of Science, Medicine and Health, University of Wollongong, Wollongong, NSW, 2522, Australia; Illawarra Health & Medical Research Institute, Wollongong, NSW, 2522, Australia. Electronic address: francois@uow.edu.au.'}, {'ForeName': 'Katrina', 'Initials': 'K', 'LastName': 'Weston-Green', 'Affiliation': 'School of Medicine, Faculty of Science, Medicine and Health, University of Wollongong, Wollongong, NSW, 2522, Australia; Illawarra Health & Medical Research Institute, Wollongong, NSW, 2522, Australia; Molecular Horizons, University of Wollongong, NSW, 2522, Australia. Electronic address: kweston@uow.edu.au.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Hölzel', 'Affiliation': 'Tasmanian Institute of Agriculture, University of Tasmania, Hobart, 7000, Australia. Electronic address: nadine.macha@utas.edu.au.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Nichols', 'Affiliation': 'Central Sciences Laboratory, University of Tasmania, Hobart, TAS, 7000, Australia. Electronic address: d.nichols@utas.edu.au.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Kent', 'Affiliation': 'Centre for Rural Health, University of Tasmania, Launceston, TAS, 7250, Australia. Electronic address: katherine.kent@utas.edu.au.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Williams', 'Affiliation': 'Department of Agriculture and Fisheries, QLD, 4108, Australia. Electronic address: david.williams@daf.qld.gov.au.'}, {'ForeName': 'Ian M R', 'Initials': 'IMR', 'LastName': 'Wright', 'Affiliation': 'School of Medicine, Faculty of Science, Medicine and Health, University of Wollongong, Wollongong, NSW, 2522, Australia; Illawarra Health & Medical Research Institute, Wollongong, NSW, 2522, Australia; College of Medicine and Dentistry, James Cook University, Cairns, QLD, 4870, Australia. Electronic address: ian.wright@jcu.edu.au.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Charlton', 'Affiliation': 'School of Medicine, Faculty of Science, Medicine and Health, University of Wollongong, Wollongong, NSW, 2522, Australia; Illawarra Health & Medical Research Institute, Wollongong, NSW, 2522, Australia. Electronic address: karenc@uow.edu.au.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2020.09.041']
1447,33071075,"Comparison of manual and mechanical chest compression techniques using cerebral oximetry in witnessed cardiac arrests at the emergency department: A prospective, randomized clinical study.","AIM


We aimed to compare regional cerebral oxygen saturation (rSO 2 ) levels during cardiopulmonary resuscitation (CPR), performed either manually or using a mechanical chest compression device (MCCD), in witnessed cardiac arrest cases in the emergency department (ED), and to evaluate the effects of both the CPR methods and perfusion levels on patient survival and neurological outcomes.
METHODS


This single-center, randomized study recruited patients aged ≥18 years who had witnessed a cardiopulmonary arrest in the ED. According to the relevant guidelines, CPR was performed either manually or using an MCCD. Simultaneously, rSO 2  levels were continually measured with near-infrared spectroscopy.
RESULTS


Seventy-five cases were randomly distributed between the MCCD (n = 40) and manual CPR (n = 35) groups. No significant difference in mean rSO 2  levels was found between the MCCD and manual CPR groups (46.35 ± 14.04 and 46.60 ± 12.09, respectively; p = 0.541). However, a significant difference in rSO 2  levels was found between patients without return of spontaneous circulation (ROSC) and those with ROSC (40.35 ± 10.05 and 50.50 ± 13.44, respectively; p < 0.001). In predicting ROSC, rSO 2  levels ≥24% provided 100% sensitivity (95% confidence interval [CI] 92-100), and rSO 2  levels ≥64% provided 100% specificity (95% CI 88-100). The area under the curve for ROSC prediction using rSO 2  levels during CPR was 0.74 (95% CI 0.62-0.83).
CONCLUSION


A relationship between ROSC and high rSO 2  levels in witnessed cardiac arrests exists. Monitoring rSO 2  levels during CPR would be useful in CPR management and ROSC prediction. During CPR, MCCD or manual chest compression has no distinct effect on oxygen delivery to the brain.
TRIAL REGISTRATION


clinicaltrials.gov identifier: NCT03238287.",2020,"No significant difference in mean rSO 2  levels was found between the MCCD and manual CPR groups (46.35 ± 14.04 and 46.60 ± 12.09, respectively; p = 0.541).","['Seventy-five cases', 'witnessed cardiac arrests at the emergency department', 'witnessed cardiac arrest cases in the emergency department (ED', 'patients aged ≥18\xa0years who had witnessed a cardiopulmonary arrest in the ED']","['cardiopulmonary resuscitation (CPR), performed either manually or using a mechanical chest compression device (MCCD', 'manual and mechanical chest compression techniques', 'MCCD', 'cerebral oximetry']","['mean rSO 2  levels', 'patient survival and neurological outcomes', 'regional cerebral oxygen saturation (rSO 2 ) levels', 'rSO 2  levels']","[{'cui': 'C4319621', 'cui_str': '75'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0600228', 'cui_str': 'Cardiorespiratory arrest'}]","[{'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456948', 'cui_str': 'Level 2'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C4273907', 'cui_str': 'Cerebral oxygen saturation'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",75.0,0.07811,"No significant difference in mean rSO 2  levels was found between the MCCD and manual CPR groups (46.35 ± 14.04 and 46.60 ± 12.09, respectively; p = 0.541).","[{'ForeName': 'Filiz', 'Initials': 'F', 'LastName': 'Baloglu Kaya', 'Affiliation': 'Eskisehir Osmangazi University, Faculty of Medicine, Department of Emergency Medicine, Buyukdere Mah, Prof. Dr. Nabi AVCI Bulvarı No: 4, 26040 Odunpazarı, Eskisehir, Turkey. Electronic address: fbaloglu@ogu.edu.tr.'}, {'ForeName': 'Nurdan', 'Initials': 'N', 'LastName': 'Acar', 'Affiliation': 'Eskisehir Osmangazi University, Faculty of Medicine, Department of Emergency Medicine, Buyukdere Mah, Prof. Dr. Nabi AVCI Bulvarı No: 4, 26040 Odunpazarı, Eskisehir, Turkey.'}, {'ForeName': 'Engin', 'Initials': 'E', 'LastName': 'Ozakin', 'Affiliation': 'Eskisehir Osmangazi University, Faculty of Medicine, Department of Emergency Medicine, Buyukdere Mah, Prof. Dr. Nabi AVCI Bulvarı No: 4, 26040 Odunpazarı, Eskisehir, Turkey.'}, {'ForeName': 'Mustafa Emin', 'Initials': 'ME', 'LastName': 'Canakci', 'Affiliation': 'Eskisehir Osmangazi University, Faculty of Medicine, Department of Emergency Medicine, Buyukdere Mah, Prof. Dr. Nabi AVCI Bulvarı No: 4, 26040 Odunpazarı, Eskisehir, Turkey.'}, {'ForeName': 'Caglar', 'Initials': 'C', 'LastName': 'Kuas', 'Affiliation': 'Eskisehir Osmangazi University, Faculty of Medicine, Department of Emergency Medicine, Buyukdere Mah, Prof. Dr. Nabi AVCI Bulvarı No: 4, 26040 Odunpazarı, Eskisehir, Turkey.'}, {'ForeName': 'Muzaffer', 'Initials': 'M', 'LastName': 'Bilgin', 'Affiliation': 'Eskisehir Osmangazi University, Faculty of Medicine, Department of Biostatistics, Buyukdere Mah, Prof. Dr. Nabi AVCI Bulvarı No: 4, 26040 Odunpazarı, Eskisehir, Turkey.'}]",The American journal of emergency medicine,['10.1016/j.ajem.2020.06.031']
1448,33071088,Intravenous magnesium sulfate vs. morphine sulfate in relieving renal colic: A randomized clinical trial.,"OBJECTIVE


Renal colic emerging from renal stone is virtually the most severe pain which is experienced. Intravenous infusion of morphine sulfate is known as a usual treatment for the disease. This study was designed to compare the efficacy of magnesium sulfate vs morphine sulfate in renal colic relief as for analgesic effect as well as lack of morphine sulfate side effects when using magnesium sulfate.
METHODS


We conducted a double-blind randomized clinical trial in renal colic patients who had referred to the emergency department of Shahid Sadoughi Hospital in Yazd, Iran. A total of 80 eligible patients were selected and randomly assigned into two groups; patients in the case group received 50 mg/kg intravenous magnesium sulfate, and those in the control group 0.1 mg/kg intravenous morphine. The primary outcome was the pain score measured on a numerical rating scale at 0, 10 and 20 minutes after infusion. Data were analyzed using SPSS 16 .
RESULTS


The two groups were similar in terms of demographic features and pain intensity at the time of referral (P <.0001). Ten minutes after drug administration, the pain mean score in the morphine group leveled at 4.88, and in the magnesium group 5.70, which proved to be greater in the morphine group (P- = 0.06). However, the pain mean score turned out to be 3.65 in the morphine group and 3.20 in the magnesium group thus significantly indifferent (P = .48).
CONCLUSIONS


In this study, we concluded that administration of intravenous 50 mg/kg magnesium sulfate could be as effective as morphine in reducing renal colic without any further complications.",2020,The two groups were similar in terms of demographic features and pain intensity at the time of referral (P <.0001).,"['renal colic patients who had referred to the emergency department of Shahid Sadoughi Hospital in Yazd, Iran', '80 eligible patients']","['magnesium', 'intravenous 50\xa0mg/kg magnesium sulfate', 'magnesium sulfate vs morphine sulfate', '50\xa0mg/kg intravenous magnesium sulfate, and those in the control group 0.1\xa0mg/kg intravenous morphine', 'morphine', 'Intravenous magnesium sulfate vs. morphine sulfate', 'morphine sulfate']","['demographic features and pain intensity', 'renal colic relief', 'relieving renal colic', 'renal colic', 'pain mean score', 'pain score measured on a numerical rating scale']","[{'cui': 'C0152169', 'cui_str': 'Renal colic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}, {'cui': 'C0066814', 'cui_str': 'Morphine sulfate'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0152169', 'cui_str': 'Renal colic'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0332303', 'cui_str': 'Relieved by'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",80.0,0.314047,The two groups were similar in terms of demographic features and pain intensity at the time of referral (P <.0001).,"[{'ForeName': 'Akram', 'Initials': 'A', 'LastName': 'Zolfaghari Sadrabad', 'Affiliation': 'Clinical Research Development Center, Imam Reza Hospital, School of Medicine, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Soheila', 'Initials': 'S', 'LastName': 'Azimi Abarghouei', 'Affiliation': 'Emergency Medicine Department, Shahid Sadoughi Hospital, Shahid Sadoughi University of Medical Sciences, Yazd, Iran. Electronic address: soheila.azimi1987@gmail.com.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Farahmand Rad', 'Affiliation': 'Clinical Research Development Center, Imam Reza Hospital, School of Medicine, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Yahya', 'Initials': 'Y', 'LastName': 'Salimi', 'Affiliation': 'Social Development and Health Promotion Research Center, Health Institute, Kermanshah University of Medical Sciences, Kermanshah, Iran; Department of Epidemiology, School of Public Health, Kermanshah University of Medical Sciences, Kermanshah, Iran. Electronic address: yahya.salimi@kums.ac.ir.'}]",The American journal of emergency medicine,['10.1016/j.ajem.2020.07.035']
1449,33071098,Variation in opioid analgesia administration and discharge prescribing for emergency department patients with suspected urolithiasis.,"OBJECTIVE


Previous research has suggested caution about opioid analgesic usage in the emergency department (ED) setting and raised concerns about variations in prescription opioid analgesic usage, both across institutions and for whom they are prescribed. We examined opioid analgesic usage in ED patients with suspected urolithiasis across fifteen participating hospitals.
METHODS


This is a secondary analysis of a clinical trial including adult ED patients with suspected urolithiasis. In multilevel models accounting for clustering by hospital, we assessed demographic, clinical, state-level, and hospital-level factors associated with opioid analgesic administration during the ED visit and prescription at discharge.
RESULTS


Of 2352 participants, 67% received an opioid analgesic during the ED visit and 61% were prescribed one at discharge. Opioid analgesic usage varied greatly across hospitals, ranging from 46% to 88% (during visit) and 34% to 85% (at discharge). Hispanic patients were less likely than non-Hispanic white patients to receive opioid analgesics during the ED visit (OR 0.72, 95% CI 0.55-0.94). Patients with higher education (OR 1.29, 95% CI 1.05-1.59), health insurance coverage (OR 1.27, 95% CI 1.02-1.60), or receiving care in states with a prescription drug monitoring program (OR 1.64, 95% CI 1.06-2.53) were more likely to receive an opioid analgesic prescription at ED discharge.
CONCLUSION


We found marked hospital-level differences in opioid analgesic administration and prescribing, as well as associations with education, healthcare insurance, and race/ethnicity groups. These data might compel clinicians and hospitals to examine their opioid use practices to ensure it is congruent with accepted medical practice.",2020,"Patients with higher education (OR 1.29, 95% CI 1.05-1.59), health insurance coverage (OR 1.27, 95% CI 1.02-1.60), or receiving care in states with a prescription drug monitoring program (OR 1.64, 95% CI 1.06-2.53) were more likely to receive an opioid analgesic prescription at ED discharge.
","['emergency department patients with suspected urolithiasis', 'Of 2352 participants, 67% received an', 'Hispanic patients', 'adult ED patients with suspected urolithiasis', 'ED patients with suspected urolithiasis across fifteen participating hospitals']",['opioid analgesic'],"['health insurance coverage', 'Opioid analgesic usage']","[{'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0451641', 'cui_str': 'Urolithiasis'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0002772', 'cui_str': 'OPIOIDS'}]","[{'cui': 'C0021682', 'cui_str': 'Health Insurance'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0457083', 'cui_str': 'Usage'}]",2352.0,0.101715,"Patients with higher education (OR 1.29, 95% CI 1.05-1.59), health insurance coverage (OR 1.27, 95% CI 1.02-1.60), or receiving care in states with a prescription drug monitoring program (OR 1.64, 95% CI 1.06-2.53) were more likely to receive an opioid analgesic prescription at ED discharge.
","[{'ForeName': 'Anna E', 'Initials': 'AE', 'LastName': 'Wentz', 'Affiliation': 'Brown University School of Public Health, Department of Epidemiology, Box G-121-3, Providence, RI 02912, USA. Electronic address: a_wentz@brown.edu.'}, {'ForeName': 'Ralph R C', 'Initials': 'RRC', 'LastName': 'Wang', 'Affiliation': 'Emergency Medicine, University of California, San Francisco, San Francisco, CA, USA. Electronic address: Ralph.Wang@ucsf.edu.'}, {'ForeName': 'Brandon D L', 'Initials': 'BDL', 'LastName': 'Marshall', 'Affiliation': 'Brown University School of Public Health, Department of Epidemiology, Providence, RI, USA. Electronic address: brandon_marshall@brown.edu.'}, {'ForeName': 'Theresa I', 'Initials': 'TI', 'LastName': 'Shireman', 'Affiliation': 'Brown University School of Public Health, Health Services Policy & Practice, Providence, RI, USA. Electronic address: theresa_shireman@brown.edu.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Liu', 'Affiliation': 'Brown University School of Public Health, Data & Statistics Core of Brown Alcohol Research Center on HIV (ARCH), Providence, RI, USA. Electronic address: tliu@stat.brown.edu.'}, {'ForeName': 'Roland C', 'Initials': 'RC', 'LastName': 'Merchant', 'Affiliation': ""Harvard Medical School, Brigham and Women's Hospital Department of Emergency Medicine, Boston, MA, USA. Electronic address: rmerchant@bwh.harvard.edu.""}]",The American journal of emergency medicine,['10.1016/j.ajem.2020.07.016']
1450,33071153,Effectiveness of two thermal activated orthodontic archwire sequences based on transition temperature range during alignment: A randomized non-controlled comparative study.,"INTRODUCTION


It has been suggested that heat-activated NiTi archwires (HANT) speed up crowding alleviation. HANT wires are available with different austenite finish temperatures.
OBJECTIVE


The aim of the present study was to compare the effectiveness of two alignment sequences using thermally activated archwires with different austenite activation temperatures for the correction of mandibular anterior crowding.
MATERIAL AND METHODS


The following NiTi archwire sequence was used for both groups: 0.012 in (conventional NiTi), 0.018 in (heat-activated NiTi archwires), 0.016×0.022 in (heat-activated NiTi archwires) and 0.019×0.025 in (conventional NiTi). The conventional NiTi used for both groups belongs to the same commercial brand. Two different austenite activation temperatures (35°C and 37°C) were used for the heat-activated archwires. The primary outcome was the degree of crowding correction measured on study models. The secondary outcome was crowding survival time over a six-month period. This RTC included fifty-four patients that were randomly allocated to the two different archwire sequences. A Mann-Whitney test was used to compare the groups regarding crowding alleviation. A survival curve was created using the Kaplan-Meier method to illustrate the reduction of crowding over time. A Mantel-Cox log-rank test was used to compare survival times (until correction of crowding).
RESULTS


No differences in crowding alleviation were identified between both groups (log-rank test; P=0.77).
CONCLUSIONS


The two alignment sequences with different thermal activated archwires at 35°C and 37°C achieved similar clinical results during the correction of mandibular anterior crowding.",2020,"No differences in crowding alleviation were identified between both groups (log-rank test; P=0.77).
",[],['thermal activated orthodontic archwire sequences'],"['survival times', 'degree of crowding correction', 'crowding alleviation', 'crowding survival time']",[],"[{'cui': 'C0399148', 'cui_str': 'Activate orthodontic archwire'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}]","[{'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0010383', 'cui_str': 'Crowding'}]",54.0,0.0359829,"No differences in crowding alleviation were identified between both groups (log-rank test; P=0.77).
","[{'ForeName': 'Júlio', 'Initials': 'J', 'LastName': 'de Araújo Gurgel', 'Affiliation': 'São Paulo State University, Department of Speech-Language Pathology, Marília, São Paulo, Brazil. Electronic address: julio.gurgel@unesp.br.'}, {'ForeName': 'Célia Regina Maio', 'Initials': 'CRM', 'LastName': 'Pinzan-Vercelino', 'Affiliation': 'Ceuma University, Department of Orthodontics, São Luís, Maranhão, Brazil.'}, {'ForeName': 'Meire Coelho', 'Initials': 'MC', 'LastName': 'Ferreira', 'Affiliation': 'Ceuma University, Department of Orthodontics, São Luís, Maranhão, Brazil.'}, {'ForeName': 'Daniella', 'Initials': 'D', 'LastName': 'de Oliveira da Silva', 'Affiliation': 'Ceuma University, Department of Orthodontics, São Luís, Maranhão, Brazil.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Flores-Mir', 'Affiliation': 'University of Alberta, School of Dentistry, Department of Orthodontics, Edmonton, Alberta, Canada.'}, {'ForeName': 'Edson Albano', 'Initials': 'EA', 'LastName': 'Schwartz', 'Affiliation': 'São Leopoldo Mandic Institute and Research Center Campinas, Department of Orthodontics, Campinas, São Paulo, Brazil.'}]",International orthodontics,['10.1016/j.ortho.2020.09.006']
1451,33071159,Patient Characteristics Are Not Associated With Documentation of Weight and Heart Failure Related Sign and Symptom Assessment in Skilled Nursing Facilities.,"OBJECTIVE


Monitoring body weight and signs and symptoms related to heart failure (HF) can alert clinicians to a patient's worsening condition but the degree to which these practices are performed in skilled nursing facilities (SNFs) is unknown. This study analyzed the frequency of these monitoring practices in SNFs and explored associated factors at both the patient and SNF level.
DESIGN


An observational study of data from the usual care arm of the SNF Connect Trial, a randomized cluster trial of a HF disease management intervention. The data extracted from charts were combined with publicly available facility data. A linear regression model was estimated to evaluate the frequency of HF disease management conditional on patient and facility covariates.
SETTING


Data from 28 SNFs in Colorado.
PARTICIPANTS


Patients discharged from hospital to SNFs with a primary or secondary diagnosis of HF.
MEASUREMENTS


Patient-level covariates included demographics, New York Heart Association class, type of HF, and Charlson comorbidity index. Facility-level covariates were from Nursing Home Compare.
RESULTS


The sample (n = 320) was majority female (66%), white (93%), with mean age 80 ± 10 years and a Charlson comorbidity index of 3.2 ± 1.5. Seventy percent had HF with preserved ejection fraction, mean ejection fraction of 50 ± 16% and 40% with a New York Heart Association class III-IV. On average, patients were weighed 40% of their days in the SNF and had documentation of at least 1 HF-related sign or symptom 70% of their days in the SNF. Patient-level factors were not associated with frequency of documenting weight and assessments of HF-related signs/symptoms. Health Inspection Star Rating was positively associated with weight monitoring (P < .05) but not associated with symptom assessment.
CONCLUSIONS AND IMPLICATIONS


Patient-level factors are not meaningfully associated with the documentation of weight tracking or sign/symptom assessment. Monitoring weight was instead associated with the Health Inspection Star Rating.",2020,"Health Inspection Star Rating was positively associated with weight monitoring (P < .05) but not associated with symptom assessment.
","['The sample (n\xa0=\xa0320) was majority female (66%), white (93%), with mean age 80\xa0±\xa010\xa0years and a Charlson comorbidity index of 3.2\xa0±\xa01.5', 'Skilled Nursing Facilities', 'Data from 28 SNFs in Colorado', 'Seventy percent had HF with preserved ejection fraction, mean ejection fraction of 50\xa0±\xa016% and 40% with a New York Heart Association class III-IV', 'Patients discharged from hospital to SNFs with a primary or secondary diagnosis of HF']",['HF disease management intervention'],"['Monitoring weight', 'Health Inspection Star Rating', 'demographics, New York Heart Association class, type of HF, and Charlson comorbidity index', 'Documentation of Weight and Heart Failure']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C4517711', 'cui_str': '320'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4546361', 'cui_str': 'Charlson Comorbidity Index'}, {'cui': 'C4517687', 'cui_str': '3.2'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0037265', 'cui_str': 'Skilled nursing facility'}, {'cui': 'C0009399', 'cui_str': 'Colorado'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C2960127', 'cui_str': 'Heart failure with normal ejection fraction'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0441887', 'cui_str': 'Class 3'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0332138', 'cui_str': 'Secondary diagnosis'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]","[{'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0513836', 'cui_str': 'Weight monitoring'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0199219', 'cui_str': 'Inspection'}, {'cui': 'C0282064', 'cui_str': 'Stars, Celestial'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C4546361', 'cui_str': 'Charlson Comorbidity Index'}, {'cui': 'C0175636', 'cui_str': 'Documentation procedure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]",,0.0206622,"Health Inspection Star Rating was positively associated with weight monitoring (P < .05) but not associated with symptom assessment.
","[{'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Morrow', 'Affiliation': 'Colorado School of Public Health, Anschutz Medical Campus, Aurora, CO. Electronic address: Cynthia.Morrow@CUAnschutz.edu.'}, {'ForeName': 'Marcelo Coca', 'Initials': 'MC', 'LastName': 'Perraillon', 'Affiliation': 'Colorado School of Public Health, Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': 'Andrea E', 'Initials': 'AE', 'LastName': 'Daddato', 'Affiliation': 'University of Colorado School of Medicine, Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': 'Blaine P', 'Initials': 'BP', 'LastName': 'Reeder', 'Affiliation': 'Sinclair School of Nursing, Informatics Institute, University of Missouri, Columbia, MO.'}, {'ForeName': 'Heidi L', 'Initials': 'HL', 'LastName': 'Wald', 'Affiliation': 'SCL Health, Broomfield, CO.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Battaglia', 'Affiliation': 'Colorado School of Public Health, Anschutz Medical Campus, Aurora, CO; Department of Veterans Affairs, Eastern Colorado Health Care System, Aurora, CO.'}, {'ForeName': 'Rebecca S', 'Initials': 'RS', 'LastName': 'Boxer', 'Affiliation': 'Institute for Health Research, Kaiser Permanente, Aurora, CO.'}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2020.08.033']
1452,33071178,Effect of surgical versus medical therapy on estimated cardiovascular event risk among adolescents with type 2 diabetes and severe obesity.,"BACKGROUND


Cardiovascular disease (CVD) remains the leading cause of mortality in type 2 diabetes (T2D). Better interventions are needed to mitigate the high lifetime risk for CVD in youth T2D.
OBJECTIVE


To compare 30-year risk for CVD events in 2 cohorts of adolescents with T2D and severe obesity undergoing medical or surgical treatment of T2D.
SETTING


Longitudinal multicenter studies at University hospitals.
METHODS


A secondary analysis of data collected from the participants with T2D enrolled in the Teen-Longitudinal Assessment of Bariatric Surgery (Teen-LABS, n = 30) and participants of similar age and racial distribution from the Treatment Options of Type 2 Diabetes in Adolescents and Youth (TODAY, n = 63) studies was performed. Teen-LABS participants underwent metabolic bariatric surgery (MBS). TODAY participants were randomized to metformin alone or in combination with rosiglitazone or intensive lifestyle intervention, with insulin therapy given for glycemic progression. A 30-year CVD event score developed by the Framingham Heart Study was the primary outcome, assessed at baseline (preoperatively for Teen-LABS), 1 year, and 5 years of follow-up.
RESULTS


Participants with T2D from Teen-LABS (n = 30; mean ± SD age = 16.9 ± 1.3 yr; 70% female; 60% white; body mass index (BMI) = 54.4 ± 9.5 kg/m 2 ) and TODAY (n = 63; 15.3 ± 1.3 yr; 56% female; 71% white; BMI 40.5 ± 4.9 kg/m 2 ) were compared. The likelihood of CVD events was higher in Teen-LABS versus TODAY at baseline (17.66 [1.59] versus 12.11 [.79]%, adjusted P = .002). One year after MBS, event risk was significantly lower in Teen-LABS versus TODAY (6.79 [1.33] versus 13.64 [0.96]%, adjusted P < .0001), and sustained at 5 years follow-up (adjusted P < .0001).
CONCLUSION


Despite higher pretreatment risk for CVD events, treatment with MBS resulted in a reduction in estimated CVD event risks, whereas medical therapy associated with an increase in risk among adolescents with T2D and severe obesity.",2020,"The likelihood of CVD events was higher in Teen-LABS versus TODAY at baseline (17.66 [1.59] versus 12.11 [.79]%, adjusted P = .002).","['adolescents with type 2 diabetes and severe obesity', 'participants with T2D enrolled in the Teen-Longitudinal Assessment of Bariatric Surgery (Teen-LABS, n = 30) and participants of similar age and racial distribution from the Treatment Options of Type 2 Diabetes in Adolescents and Youth (TODAY, n = 63) studies was performed', 'adolescents with T2D and severe obesity', '2 cohorts of adolescents with T2D and severe obesity undergoing medical or surgical treatment of T2D.\nSETTING\n\n\nLongitudinal multicenter studies at University hospitals', 'Participants with T2D from Teen-LABS (n = 30; mean ± SD age = 16.9 ± 1.3 yr; 70% female; 60% white; body mass index (BMI) = 54.4 ± 9.5 kg/m 2 ) and TODAY (n = 63; 15.3 ± 1.3 yr; 56% female; 71% white; BMI 40.5 ± 4.9 kg/m 2 ']","['metabolic bariatric surgery (MBS', 'surgical versus medical therapy', 'MBS', 'metformin alone or in combination with rosiglitazone or intensive lifestyle intervention, with insulin therapy']","['likelihood of CVD events', 'estimated CVD event risks', 'risk', 'event risk']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0028756', 'cui_str': 'Morbid obesity'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0310367', 'cui_str': 'Today'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C1096776', 'cui_str': 'Multicenter Studies'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517499', 'cui_str': '1.3'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517899', 'cui_str': '9.5'}, {'cui': 'C4517578', 'cui_str': '15.3'}]","[{'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0289313', 'cui_str': 'rosiglitazone'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",,0.0954744,"The likelihood of CVD events was higher in Teen-LABS versus TODAY at baseline (17.66 [1.59] versus 12.11 [.79]%, adjusted P = .002).","[{'ForeName': 'Justin R', 'Initials': 'JR', 'LastName': 'Ryder', 'Affiliation': 'University of Minnesota Medical School and Center for Pediatric Obesity Medicine, Minneapolis, Minnesota, United States.'}, {'ForeName': 'Peixin', 'Initials': 'P', 'LastName': 'Xu', 'Affiliation': ""University of Cincinnati, Cincinnati Children's Medical Center, Cincinnati, Ohio, United States.""}, {'ForeName': 'Kristen J', 'Initials': 'KJ', 'LastName': 'Nadeau', 'Affiliation': ""University of Colorado Anschutz Medical Campus and Children's Hospital Colorado, Aurora, Colorado, United States.""}, {'ForeName': 'Megan M', 'Initials': 'MM', 'LastName': 'Kelsey', 'Affiliation': ""University of Colorado Anschutz Medical Campus and Children's Hospital Colorado, Aurora, Colorado, United States.""}, {'ForeName': 'Changchun', 'Initials': 'C', 'LastName': 'Xie', 'Affiliation': ""University of Cincinnati, Cincinnati Children's Medical Center, Cincinnati, Ohio, United States.""}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Jenkins', 'Affiliation': ""University of Cincinnati, Cincinnati Children's Medical Center, Cincinnati, Ohio, United States.""}, {'ForeName': 'Thomas H', 'Initials': 'TH', 'LastName': 'Inge', 'Affiliation': ""University of Colorado Anschutz Medical Campus and Children's Hospital Colorado, Aurora, Colorado, United States.""}, {'ForeName': 'Petter', 'Initials': 'P', 'LastName': 'Bjornstad', 'Affiliation': ""University of Colorado Anschutz Medical Campus and Children's Hospital Colorado, Aurora, Colorado, United States. Electronic address: petter.bjornstad@childrenscolorado.org.""}]",Surgery for obesity and related diseases : official journal of the American Society for Bariatric Surgery,['10.1016/j.soard.2020.09.002']
1453,33071184,Does placebo effect exist in contact lens discomfort management?,"PURPOSE


To study the effect of daily disposable contact lens (DDCL) refitting in monthly contact lens (CL) wearers suffering from contact lens discomfort (CLD), and to assess if there is a placebo effect associated with this CLD intervention.
METHODS


Symptomatic CL wearers, according to the Contact Lens Dry Eye Questionnaire 8 (CLDEQ-8 ≥ 12 points), were divided into two groups. The study group was provided with DDCLs (delefilcon A) and the control group with a masked pair of their habitual monthly CLs (placebo effect) and were assessed after one month. Then, the control group was provided with the same DDCLs and evaluated one month later. The symptoms were recorded with the CLDEQ-8 and global rating of change scale (GRCS). Non-invasive tear break-up time (NITBUT), conjunctival hyperaemia, fluorescein staining, and lid wiper epitheliopathy (LWE) were evaluated. Changes between visits, groups, and the effect of each intervention were analysed.
RESULTS


Thirty-one participants (mean age: 23.2 ± 5.3 years) were recruited. The study group (n = 14) showed an improvement of -39.6 ± 25.8 % (p < 0.001) in CLDEQ-8 and 31.3 ± 14.6 points in GRCS (p < 0.001) after one month of DDCL use, while no changes in clinical tests were found. In the control group (n = 17), symptoms improved significantly after wearing the masked monthly CL (CLDEQ-8: -26.1 ± 31.0 %, p = 0.03; GRCS: 14.9 ± 17.0, p = 0.002), however a worsening in bulbar (26.5 ± 40.0 %; p = 0.02) and limbal hyperaemia (21.6 ± 34.7 %, p = 0.02) and an improvement of -19.1 ± 37.0 % (p = 0.049) in LWE was found. When the control group was fitted with the DDCL, improvements in GRCS (20.5 ± 25.5, p = 0.02), NITBUT (37.9 ± 42.3 %, p = 0.002), and conjunctival staining (-47.1 ± 59.9 %, p = 0.005) were noted.
CONCLUSIONS


Refitting symptomatic monthly CL wearers with Delefilcon A DDCL is effective in reducing symptoms related to CLD. However, clinicians and researchers must be aware of the existence of a placebo effect when assessing the effectiveness of any CL refitting.",2020,Refitting symptomatic monthly CL wearers with Delefilcon A DDCL is effective in reducing symptoms related to CLD.,"['Thirty-one participants (mean age: 23.2 ± 5.3 years) were recruited', 'monthly contact lens (CL) wearers suffering from contact lens discomfort (CLD', 'Symptomatic CL wearers, according to the Contact Lens Dry Eye Questionnaire 8 (CLDEQ-8 ≥ 12 points']","['DDCLs (delefilcon A) and the control group with a masked pair of their habitual monthly CLs (placebo effect', 'placebo', 'daily disposable contact lens (DDCL', 'Delefilcon A DDCL']","['CLDEQ-8 and global rating of change scale (GRCS). Non-invasive tear break-up time (NITBUT), conjunctival hyperaemia, fluorescein staining, and lid wiper epitheliopathy (LWE', 'limbal hyperaemia', 'conjunctival staining', 'worsening in bulbar']","[{'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4708663', 'cui_str': '5.3'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0009836', 'cui_str': 'Contact lenses'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0920138', 'cui_str': 'Contact lens wearer'}, {'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0006790', 'cui_str': 'Calusterone'}, {'cui': 'C0032041', 'cui_str': 'Placebo Effect'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C1444754', 'cui_str': 'Length'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1761613', 'cui_str': 'Conjunctival hyperemia'}, {'cui': 'C0060520', 'cui_str': 'Fluorescein'}, {'cui': 'C0423193', 'cui_str': 'Limbal hyperemia'}, {'cui': 'C3203718', 'cui_str': 'Conjunctival staining'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}]",31.0,0.062167,Refitting symptomatic monthly CL wearers with Delefilcon A DDCL is effective in reducing symptoms related to CLD.,"[{'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Arroyo-Del Arroyo', 'Affiliation': 'Instituto Universitario de Oftalmobiología Aplicada (IOBA), Universidad de Valladolid, Valladolid, Spain; Departamento de Física Teórica, Atómica y Óptica, Universidad de Valladolid, Valladolid, Spain.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Novo-Diez', 'Affiliation': 'Instituto Universitario de Oftalmobiología Aplicada (IOBA), Universidad de Valladolid, Valladolid, Spain; Departamento de Física Teórica, Atómica y Óptica, Universidad de Valladolid, Valladolid, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Blanco-Vázquez', 'Affiliation': 'Instituto Universitario de Oftalmobiología Aplicada (IOBA), Universidad de Valladolid, Valladolid, Spain.'}, {'ForeName': 'Itziar', 'Initials': 'I', 'LastName': 'Fernández', 'Affiliation': 'Instituto Universitario de Oftalmobiología Aplicada (IOBA), Universidad de Valladolid, Valladolid, Spain; Networking Research Center on Bioengineering, Biomaterials and Nanomedicine (CIBER-BBN), Valladolid, Spain.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'López-Miguel', 'Affiliation': 'Instituto Universitario de Oftalmobiología Aplicada (IOBA), Universidad de Valladolid, Valladolid, Spain; Redes temáticas de investigación cooperativa en salud (Oftared), Instituto de Salud Carlos III, Madrid, Spain. Electronic address: alopezm@ioba.med.uva.es.'}, {'ForeName': 'María Jesús', 'Initials': 'MJ', 'LastName': 'González-García', 'Affiliation': 'Instituto Universitario de Oftalmobiología Aplicada (IOBA), Universidad de Valladolid, Valladolid, Spain; Departamento de Física Teórica, Atómica y Óptica, Universidad de Valladolid, Valladolid, Spain; Networking Research Center on Bioengineering, Biomaterials and Nanomedicine (CIBER-BBN), Valladolid, Spain.'}]",Contact lens & anterior eye : the journal of the British Contact Lens Association,['10.1016/j.clae.2020.09.003']
1454,33071199,The impact of the mechanical whole-body vibration experienced during military land transit on the physical attributes underpinning dismounted combatant physical performance: A randomised controlled trial.,"OBJECTIVES


The aim of this randomised controlled trial was to explore the impact of the mechanical WBV experienced during simulated military land transit on the physical attributes that underpin tasks performed by dismounted combatants.
DESIGN


This study used a parallel group randomised control trial design.
METHODS


Sixty participants were randomly assigned to one of four, 2-h laboratory-based simulations (restricted posture, sealed road, cross country or a control condition). A smaller sample of 16 Australian Defence Force infantry personnel served as a validation group and were exposed to the same conditions. Neither the restricted posture nor the control conditions were exposed to any WBV, but the former were secured in place using the built-in seat harness. Prior to, and following the assigned condition, participants performed a series of battlefield relevant physical performance tests including; drop jump, 20-m sprint, reactive agility, arm-hand steadiness, isometric mid-thigh pull, and sit-and-reach.
RESULTS


Medium decreases in the drop jump were observed for both the sealed road (effect size [ES]=0.53) and cross-country (ES=0.97) simulation conditions indicating a decrease in performance of the jump phase. A large decrease in 20-m sprint performance was observed in both the sealed road (ES=1.37) and cross-country (ES=0.88) exposure conditions. Additionally, a large decrease in 20-m sprint performance was observed for the restricted posture (ES=1.02) exposure condition.
CONCLUSIONS


These findings indicate that exposure to WBV experienced during motorised land transit has a negative influence on aspects of lower body explosive strength.",2020,A large decrease in 20-m sprint performance was observed in both the sealed road (ES=1.37) and cross-country (ES=0.88) exposure conditions.,['Sixty participants'],"['2-h laboratory-based simulations (restricted posture, sealed road, cross country or a control condition', 'battlefield relevant physical performance tests including; drop jump, 20-m sprint, reactive agility, arm-hand steadiness, isometric mid-thigh pull, and sit-and-reach', 'mechanical whole-body vibration experienced during military land transit']",['20-m sprint performance'],[],"[{'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C0442650', 'cui_str': 'Road'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0039866', 'cui_str': 'Thigh structure'}, {'cui': 'C0580846', 'cui_str': 'Does pull'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0557668', 'cui_str': 'Landing'}, {'cui': 'C1301827', 'cui_str': 'In transit'}]",[],60.0,0.0737598,A large decrease in 20-m sprint performance was observed in both the sealed road (ES=1.37) and cross-country (ES=0.88) exposure conditions.,"[{'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Debenedictis', 'Affiliation': 'Alliance for Research in Exercise, Nutrition and Activity (ARENA), University of South Australia, Australia. Electronic address: thomas.debenedictis@mymail.unisa.edu.au.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Billing', 'Affiliation': 'Defence Science and Technology Group, Department of Defence, Australia.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Milanese', 'Affiliation': 'Alliance for Research in Exercise, Nutrition and Activity (ARENA), University of South Australia, Australia.'}, {'ForeName': 'Alistair', 'Initials': 'A', 'LastName': 'Furnell', 'Affiliation': 'Public Transport Victoria, Melbourne, Australia.'}, {'ForeName': 'Grant', 'Initials': 'G', 'LastName': 'Tomkinson', 'Affiliation': 'Alliance for Research in Exercise, Nutrition and Activity (ARENA), University of South Australia, Australia; Department of Kinesology and Public Health Education, University of North Dakota, Grand Forks, USA.'}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'Thewlis', 'Affiliation': 'Centre for Orthopaedic and Trauma Research, University of Adelaide, Australia.'}]",Journal of science and medicine in sport,['10.1016/j.jsams.2020.09.020']
1455,33071206,Mitigating the effects of COVID-19 pandemic on controlling vascular risk factors among participants in a carotid stenosis trial.,"INTRODUCTION


The COVID-19 pandemic has presented challenges to managing vascular risk factors with in-person follow-up of patients with asymptomatic carotid stenosis enrolled in the CREST2 trial. CREST2 is comparing intensive medical management alone versus intensive medical management plus revascularization with endarterectomy or stenting. We performed a study to evaluate the feasibility of a home-based program for testing blood pressure (BP) and low-density lipoprotein (LDL) in CREST2.
METHODS


This study involved 45 patients at 10 sites in the CREST2 trial. The initial patients were identified by the Medical Management Core (MMC) as high-risk patients defined by stage 2 hypertension, LDL > 90 mg/dl, or both. If a patient at the site declined participation, another was substituted. All patients who agreed to participate were sent a BP monitoring device and a commercially available at-home lipid test kit that uses a self-performed finger-stick blood sample that was resulted to the patient. Training on the use of the equipment and obtaining the risk factor results was done by the study coordinator by telephone.
RESULTS


Ten of the 130 currently active CREST2 sites participated, 8 in the LDL portion and 5 in the BP portion (3 sites did both). Twenty-six BP devices and 23 lipid tests were sent to patients. Of the 26 patients who obtained BP readings with the devices, 9 were out of the study target and adjustments in BP medications were made in 3. Of the 23 patients sent LDL tests, 13 were able to perform the test showing 7 were out of target, leading to adjustments in lipid medications in 4.
CONCLUSION


This study established the feasibility of at-home monitoring of BP and LDL in a clinical trial and identified implementation challenges prior to widespread use in the trial. (ClinicalTrials.gov number NCT02089217).",2020,"Of the 23 patients sent LDL tests, 13 were able to perform the test showing 7 were out of target, leading to adjustments in lipid medications in 4.
","['23 patients sent LDL tests, 13 were able to perform the test showing 7 were out of target, leading to adjustments in lipid medications in 4', 'participants in a carotid stenosis trial', 'patients with asymptomatic carotid stenosis enrolled in the CREST2 trial', '45 patients at 10 sites in the CREST2 trial', 'initial patients were identified by the Medical Management Core (MMC) as high-risk patients defined by stage 2 hypertension, LDL ', '26 patients who obtained BP readings with the devices, 9 were out of the study target and adjustments in BP medications were made in 3']","['COVID-19 pandemic', 'CREST2']",['testing blood pressure (BP) and low-density lipoprotein (LDL'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0303134', 'cui_str': 'Beryllium-7'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0007282', 'cui_str': 'Carotid artery stenosis'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0591126', 'cui_str': 'AT-10'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1615608', 'cui_str': 'Pandemics'}]","[{'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}]",45.0,0.0283477,"Of the 23 patients sent LDL tests, 13 were able to perform the test showing 7 were out of target, leading to adjustments in lipid medications in 4.
","[{'ForeName': 'Tanya N', 'Initials': 'TN', 'LastName': 'Turan', 'Affiliation': 'Neurology, Medical University of South Carolina (MUSC), 96 Jonathan Lucas Street, MSC 606, Charleston 29425, SC, United States. Electronic address: turan@musc.edu.'}, {'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Meschia', 'Affiliation': 'Neurology, Mayo Clinic, Jacksonville, FL, United States.'}, {'ForeName': 'Marc I', 'Initials': 'MI', 'LastName': 'Chimowitz', 'Affiliation': 'Neurology, MUSC, Charleston, SC, United States.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Roldan', 'Affiliation': 'Neurology, MUSC, Charleston, SC, United States.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'LeMatty', 'Affiliation': 'Neurology, MUSC, Charleston, SC, United States.'}, {'ForeName': 'Sothear', 'Initials': 'S', 'LastName': 'Luke', 'Affiliation': 'Neurology, Mayo Clinic, Jacksonville, FL, United States.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Breathitt', 'Affiliation': 'Neurology, Baptist Health Lexington, Lexington, KY, United States.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Eiland', 'Affiliation': 'Cardiovascular Associates, Brookwood Baptist Health, Birmingham, AL, United States.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Foley', 'Affiliation': 'Neurology, Oregon Health and Science University, Portland, OR, United States.'}, {'ForeName': 'Thomas G', 'Initials': 'TG', 'LastName': 'Brott', 'Affiliation': 'Neurology, Mayo Clinic, Jacksonville, FL, United States.'}]",Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association,['10.1016/j.jstrokecerebrovasdis.2020.105362']
1456,33071207,The use of non-surgical glue to repair perineal first-degree lacerations in normal birth: A non-inferiority randomised trial.,"BACKGROUND AND PROBLEM


Surgical glue has been indicated for uncomplicated operatory wounds; however, it has a considerable cost. Non-surgical glue, a commercially available and cheaper product, has not been studied for repairing postpartum lacerations.
AIM


To compare non-surgical glue to traditional sutures on perineal first-degree lacerations after normal birth.
METHODS


In a prospective, open-label, non-inferiority, randomised controlled trial, we selected childbearing women who were admitted for normal term births and in whom skin lacerations occurred. They were assigned to laceration repair using either non-surgical glue (ethyl 2-cyanoacrylate; Glue group) or catgut sutures (Suture group). The primary endpoint was the occurrence of dehiscence >3mm. Secondary endpoints were procedure runtime, pain score, satisfaction level, and aspects of perineal repair by the REEDA score (hyperaemia, oedema, ecchymosis, exudation, and coaptation) immediately (T0), 24-48h (T1), and 7-10 days (T2) after childbirth.
FINDINGS


We included 126 women, 63 in each group, and found a non-inferiority dehiscence rate in the Glue Group compared to the Control group (T1=1.6% vs. 1.6%, P=0.999 and P<0.001 for non-inferiority; and T2=2.2% vs. 4.3%, P=0.557). In the Glue Group, the procedure runtime was shorter, pain score was lower, and women's satisfaction was greater. No women had any allergic reaction in the study.
CONCLUSIONS


Non-surgical glue was not inferior to traditional sutures to repair postpartum first-degree lacerations. In addition, non-surgical glue was associated with less pain and greater satisfaction. Brazilian Clinical Trials Registry (www.ensaiosclinicos.gov.br/rg/RBR-5Z8MKC).",2020,"In the Glue Group, the procedure runtime was shorter, pain score was lower, and women's satisfaction was greater.","['normal birth', 'selected childbearing women who were admitted for normal term births and in whom skin lacerations occurred']","['laceration repair using either non-surgical glue (ethyl 2-cyanoacrylate; Glue group) or catgut sutures (Suture group', 'non-surgical glue to repair perineal first-degree lacerations', 'traditional sutures']","['pain and greater satisfaction', 'occurrence of dehiscence >3mm', 'non-inferiority dehiscence rate', 'pain score', 'allergic reaction', 'procedure runtime, pain score, satisfaction level, and aspects of perineal repair by the REEDA score (hyperaemia, oedema, ecchymosis, exudation, and coaptation) immediately (T0), 24-48h (T1), and 7-10 days (T2) after childbirth']","[{'cui': 'C0269694', 'cui_str': 'Normal delivery procedure'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0558401', 'cui_str': 'Laceration of skin'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}]","[{'cui': 'C3701948', 'cui_str': 'Laceration repair'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0017780', 'cui_str': 'Glue'}, {'cui': 'C0059742', 'cui_str': 'ethyl cyanoacrylate'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441205', 'cui_str': 'Catgut suture'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0031066', 'cui_str': 'Perineal'}, {'cui': 'C5191054', 'cui_str': 'First degree laceration'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0149663', 'cui_str': 'Dehiscence'}, {'cui': 'C0237666', 'cui_str': 'Inferiority feeling'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0031066', 'cui_str': 'Perineal'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0020452', 'cui_str': 'Hyperemia'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0013491', 'cui_str': 'Ecchymosis'}, {'cui': 'C0311437', 'cui_str': 'Exudation'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0005615', 'cui_str': 'Birth'}]",126.0,0.118261,"In the Glue Group, the procedure runtime was shorter, pain score was lower, and women's satisfaction was greater.","[{'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Ochiai', 'Affiliation': 'University of São Paulo, School of Arts, Sciences and Humanities, São Paulo, São Paulo, Brazil. Electronic address: angelaochiai@usp.br.'}, {'ForeName': 'N M', 'Initials': 'NM', 'LastName': 'Araújo', 'Affiliation': 'University of São Paulo, School of Arts, Sciences and Humanities, São Paulo, São Paulo, Brazil.'}, {'ForeName': 'S D T A', 'Initials': 'SDTA', 'LastName': 'Moraes', 'Affiliation': '""Amador Aguiar"" Municipal Hospital and Maternity, Osasco, São Paulo, Brazil.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Caroci-Becker', 'Affiliation': 'University of São Paulo, School of Arts, Sciences and Humanities, São Paulo, São Paulo, Brazil.'}, {'ForeName': 'L G', 'Initials': 'LG', 'LastName': 'Sparvoli', 'Affiliation': 'University of São Paulo, School of Pharmaceutical Sciences, São Paulo, São Paulo, Brazil.'}, {'ForeName': 'T T', 'Initials': 'TT', 'LastName': 'Teixeira', 'Affiliation': '""Casa Angela"" Freestanding Birth Centre, São Paulo, São Paulo, Brazil.'}, {'ForeName': 'R R', 'Initials': 'RR', 'LastName': 'Carvalho', 'Affiliation': '""Casa Angela"" Freestanding Birth Centre, São Paulo, São Paulo, Brazil.'}]",Women and birth : journal of the Australian College of Midwives,['10.1016/j.wombi.2020.09.018']
1457,33071253,Coelioscopic-assisted prefemoral ovariosalpingectomy in a d'Orbigny slider (Trachemys dorbigni) using a digital otoscope.,"The purpose of this study was to assess the unilateral prefemoral coelioscopic-assisted approach for ovariosalpingectomy in a d'Orbigny slider (Trachemys dorbigni) using a digital otoscope. Twenty healthy turtles were randomly assigned to one of two groups, for right (GR; n=10) or left (GL; n=10) prefemoral access, for coelioscopic-assisted ovariosalpingectomy. Anesthesia and surgery times, body weight, and ovary/oviduct weight data were recorded. Anesthesia and surgery times did not differ significantly between the groups. Wound closure was the most time-consuming surgical step. Ovary and body weights significantly affected the exposure time of the ipsilateral and contralateral ovaries, respectively. Two minor intraoperative complications were reported. All the animals recovered uneventfully. The digital otoscope can be safely and effectively used for coelioscopic-assisted single-access, unilateral prefemoral ovariosalpingectomy in d'Orbigny slider.",2020,"The digital otoscope can be safely and effectively used for coelioscopic-assisted single-access, unilateral prefemoral ovariosalpingectomy in d'Orbigny slider.",['Twenty healthy turtles'],"['Coelioscopic-assisted prefemoral ovariosalpingectomy', 'coelioscopic-assisted ovariosalpingectomy']","['Anesthesia and surgery times', 'Anesthesia and surgery times, body weight, and ovary/oviduct weight data', 'Ovary and body weights']","[{'cui': 'C0041412', 'cui_str': 'Turtle'}]","[{'cui': 'C0018896', 'cui_str': 'Helping Behavior'}]","[{'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0029939', 'cui_str': 'Ovarian structure'}, {'cui': 'C0015560', 'cui_str': 'Fallopian tube structure'}]",20.0,0.036281,"The digital otoscope can be safely and effectively used for coelioscopic-assisted single-access, unilateral prefemoral ovariosalpingectomy in d'Orbigny slider.","[{'ForeName': 'Bernardo Nascimento', 'Initials': 'BN', 'LastName': 'Antunes', 'Affiliation': 'Department of Small Animal Clinics, Center of Rural Science, Federal University of Santa Maria.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'da Costa', 'Affiliation': 'Veterinery Hospital of Passo Fundo, University of Passo Fundo (UPF).'}, {'ForeName': 'Michelli Westphal', 'Initials': 'MW', 'LastName': 'de Ataide', 'Affiliation': 'Department of Small Animal Clinics, Center of Rural Science, Federal University of Santa Maria.'}, {'ForeName': 'Allana Valau', 'Initials': 'AV', 'LastName': 'Moreira', 'Affiliation': 'Veterinery Hospital of Passo Fundo, University of Passo Fundo (UPF).'}, {'ForeName': 'Luis Fernando', 'Initials': 'LF', 'LastName': 'Pedrotti', 'Affiliation': 'Department of Small Animal Clinics, Center of Rural Science, Federal University of Santa Maria.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Schulz JÚnior', 'Affiliation': 'Veterinery Hospital of Passo Fundo, University of Passo Fundo (UPF).'}, {'ForeName': 'Cassiano Schmitz', 'Initials': 'CS', 'LastName': 'Nhoato', 'Affiliation': 'Veterinery Hospital of Passo Fundo, University of Passo Fundo (UPF).'}, {'ForeName': 'Renan Alves', 'Initials': 'RA', 'LastName': 'Stadler', 'Affiliation': 'Gramado Zoo.'}, {'ForeName': 'Marco Augusto Machado', 'Initials': 'MAM', 'LastName': 'Silva', 'Affiliation': 'Department of Veterinary Medicine, Federal University of Goiás.'}, {'ForeName': 'Maurício Veloso', 'Initials': 'MV', 'LastName': 'Brun', 'Affiliation': 'Department of Small Animal Clinics, Center of Rural Science, Federal University of Santa Maria.'}]",The Journal of veterinary medical science,['10.1292/jvms.20-0243']
1458,33071262,Effects of Active Learning Education on Arterial Stiffness of Older Adults with Low Health Literacy: A Randomized Controlled Trial.,"AIM


We examined the effects of active learning education on arterial stiffness and physical activity of community-dwelling older adults with low health literacy.
METHODS


This study is a secondary analysis of randomized controlled trial of 60 participants aged 65 and older with low health literacy. The intervention group (n=30) participated in a weekly 90-minute active learning program session for 24 weeks, which addressed health promotion in older age. The control group (n=30) attended a 90-minute health education class in a didactic manner. The outcomes were measured at baseline and in week 24. The degree of arterial stiffness was assessed based on the cardio-ankle vascular index (CAVI) using the VS-1500 device (Fukuda Denshi Co., Ltd., Tokyo, Japan). The shortened version of the self-reported International Physical Activity Questionnaire was used to assess the amount of total physical activity determined by the metabolic equivalent hours per week. We used analysis by intention-to-treat, with multiple imputation for missing data.
RESULTS


Seven participants (11.7%) dropped out prior to the post-intervention assessment. The multiple imputation analysis revealed that the intervention group showed significant improvement in CAVI [between-groups difference (95% confidence interval)=-0.78 (-1.25 to -0.31), Cohen's d=0.82] and physical activity [32.5 (0.3 to 64.7), Cohen's d=0.57] as compared with the control group. The sensitivity analysis for the complete cases showed similar results.
CONCLUSION


Active learning health education may be effective in improving arterial stiffness and physical activity in older adults with low health literacy.",2020,"The sensitivity analysis for the complete cases showed similar results.
","['60 participants aged 65 and older with low health literacy', 'community-dwelling older adults with low health literacy', 'older adults with low health literacy', 'Older Adults with Low Health Literacy']","['active learning education', 'Active Learning Education', '90-minute health education class in a didactic manner', '90-minute active learning program session']","['CAVI', 'cardio-ankle vascular index (CAVI', 'physical activity', 'degree of arterial stiffness', 'total physical activity', 'arterial stiffness and physical activity']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0243012', 'cui_str': 'Active Learning'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C4034558', 'cui_str': 'Cardio-ankle vascular index'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",60.0,0.0732693,"The sensitivity analysis for the complete cases showed similar results.
","[{'ForeName': 'Kazuki', 'Initials': 'K', 'LastName': 'Uemura', 'Affiliation': 'Center for Liberal Arts and Sciences, Faculty of Engineering, Toyama Prefectural University.'}, {'ForeName': 'Minoru', 'Initials': 'M', 'LastName': 'Yamada', 'Affiliation': 'Graduate School of Comprehensive Human Sciences, University of Tsukuba.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Kuzuya', 'Affiliation': 'Institutes of Innovation for Future Society, Nagoya University.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Okamoto', 'Affiliation': 'Center for Liberal Arts and Sciences, Faculty of Engineering, Toyama Prefectural University.'}]",Journal of atherosclerosis and thrombosis,['10.5551/jat.58354']
1459,33071273,Effects of resistance training using elastic bands on muscle strength with or without a leucine supplement for 48 weeks in elderly patients with type 2 diabetes.,"Type 2 diabetes is associated with sarcopenia. Resistance training and appropriate nutritional therapy are reported to be effective for muscle strength and mass. This study aimed to evaluate the effect of resistance training using elastic bands at home combined with a leucine-rich amino acid supplement on muscle strength, physical function, and muscle mass in elderly type 2 diabetes. We conducted a 48-week prospective single-center randomized controlled trial in 60 patients who were randomly allocated to one of three groups: control (C), resistance exercise (R), and resistance exercise plus supplement (RL). R and RL groups performed daily bodyweight resistance training with elastic bands exercises at home, and the RL group also took 6 g of a leucine-rich amino acid supplement daily. Knee extension strength (muscle strength), grip strength, usual gait speed (physical function), muscle mass, and cognitive function were assessed at 0 and 48 weeks. Although the change in knee extension strength from baseline was significantly increased by 6.4 Nm (95% CI 1.0, 11.7) in the RL group (p = 0.036), no significant difference was observed among the three groups (p = 0.090). Physical function, muscle mass, and cognitive function also had no changes during the study period among the three groups. No additive effect of a leucine-rich amino acid supplement on muscle strength or mass was observed. Although a post hoc analysis comparing with or without resistance training (C group vs. R + RL group) found that knee extension strength was significantly increased (p = 0.028), and cognitive decline was less (p = 0.046) than in the C group.",2020,"Although the change in knee extension strength from baseline was significantly increased by 6.4 Nm (95% CI 1.0, 11.7) in the RL group (p = 0.036), no significant difference was observed among the three groups (p = 0.090).","['60 patients who were randomly allocated to one of three groups', 'elderly patients with type 2 diabetes', 'elderly type 2 diabetes']","['resistance training', 'control (C), resistance exercise (R), and resistance exercise plus supplement (RL', 'leucine supplement', 'leucine-rich amino acid supplement', 'Resistance training and appropriate nutritional therapy']","['muscle strength, physical function, and muscle mass', 'Physical function, muscle mass, and cognitive function', 'cognitive decline', 'Knee extension strength (muscle strength), grip strength, usual gait speed (physical function), muscle mass, and cognitive function', 'knee extension strength', 'muscle strength or mass']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0023401', 'cui_str': 'Leucine'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0556082', 'cui_str': 'Amino acid supplement'}, {'cui': 'C0242739', 'cui_str': 'Nutritional support'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0234985', 'cui_str': 'Mental Deterioration'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}]",60.0,0.0260347,"Although the change in knee extension strength from baseline was significantly increased by 6.4 Nm (95% CI 1.0, 11.7) in the RL group (p = 0.036), no significant difference was observed among the three groups (p = 0.090).","[{'ForeName': 'Yutaro', 'Initials': 'Y', 'LastName': 'Yamamoto', 'Affiliation': 'Division of Metabolism and Endocrinology, Department of Internal Medicine, St. Marianna University School of Medicine, Kawasaki, Kanagawa, Japan.'}, {'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Nagai', 'Affiliation': 'Division of Metabolism and Endocrinology, Department of Internal Medicine, St. Marianna University School of Medicine, Kawasaki, Kanagawa, Japan.'}, {'ForeName': 'Shin', 'Initials': 'S', 'LastName': 'Kawanabe', 'Affiliation': 'Division of Metabolism and Endocrinology, Department of Internal Medicine, St. Marianna University School of Medicine, Kawasaki, Kanagawa, Japan.'}, {'ForeName': 'Yoshiaki', 'Initials': 'Y', 'LastName': 'Hishida', 'Affiliation': 'Division of Metabolism and Endocrinology, Department of Internal Medicine, St. Marianna University School of Medicine, Kawasaki, Kanagawa, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Hiraki', 'Affiliation': 'Department of Rehabilitation Medicine, St. Marianna University School of Medicine, Kawasaki, Kanagawa, Japan.'}, {'ForeName': 'Masakatsu', 'Initials': 'M', 'LastName': 'Sone', 'Affiliation': 'Division of Metabolism and Endocrinology, Department of Internal Medicine, St. Marianna University School of Medicine, Kawasaki, Kanagawa, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Tanaka', 'Affiliation': 'Division of Metabolism and Endocrinology, Department of Internal Medicine, St. Marianna University School of Medicine, Kawasaki, Kanagawa, Japan.'}]",Endocrine journal,['10.1507/endocrj.EJ20-0550']
1460,33071416,An Interactive Web-based Program for Stepfamilies: Development and Evaluation of Efficacy.,"This study evaluated the efficacy of a family life education program for stepfamilies that is self-administered, interactive, and web-based. The program uses behavior modeling videos to demonstrate effective couple, parenting, and stepparenting practices. A diverse sample of 300 parents/stepparents of a child age 11-15 years were randomized into either treatment or delayed-access control groups. Findings suggest that participation in the stepfamily education program positively influenced several key areas of parenting and family functioning at postprogram and at follow-up. No gender differences were noted in the findings.",2010,No gender differences were noted in the findings.,['300 parents/stepparents of a child age 11-15 years'],"['family life education program', 'delayed-access control groups']",[],"[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0282288', 'cui_str': 'Stepparent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0015608', 'cui_str': 'Family Relationship'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],300.0,0.0182437,No gender differences were noted in the findings.,"[{'ForeName': 'Vicky A', 'Initials': 'VA', 'LastName': 'Gelatt', 'Affiliation': 'Oregon Center for Applied Science, Eugene, Oregon.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Adler-Baeder', 'Affiliation': 'Auburn University.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Seeley', 'Affiliation': 'Oregon Research Institute, Eugene, Oregon.'}]",Family relations,['10.1111/j.1741-3729.2010.00624.x']
1461,33071496,A Randomized Control Trial to Assess Intraoperative and Postoperative Outcomes of Colorado Microdissection Needle Versus Conventional Surgical Knife in Neck Dissection.,"Aim


We designed a prospective randomized study to assess the outcome of Colorado microdissection needle in comparison with conventional surgical blade for performing neck dissections.
Materials and Methods


Sixty patients who underwent neck dissection for oral cancers were randomly allocated into two groups. The outcome measurements were in terms of cosmetic outcome of neck scar, intraoperative blood loss, over all operative time, and postoperative neck drain assessment.
Results


The use of microdissection needle in performing skin incision and neck dissection eliminates the need for local anesthetic with vasoconstrictor along with significant reduction in intraoperative blood loss, postoperative drainage and with acceptable cosmetic outcome. No significant difference was seen in perioperative and postoperative complications between both groups.",2020,No significant difference was seen in perioperative and postoperative complications between both groups.,"['Sixty patients who underwent neck dissection for oral cancers', 'Neck Dissection']","['conventional surgical blade', 'microdissection needle', 'Colorado Microdissection Needle Versus Conventional Surgical Knife', 'Colorado microdissection needle']","['perioperative and postoperative complications', 'cosmetic outcome of neck scar, intraoperative blood loss, over all operative time, and postoperative neck drain assessment']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0398395', 'cui_str': 'Block dissection of cervical lymph nodes'}, {'cui': 'C0153381', 'cui_str': 'Malignant tumor of oral cavity'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C1304643', 'cui_str': 'Surgical blade'}, {'cui': 'C0598304', 'cui_str': 'Microdissection'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0009399', 'cui_str': 'Colorado'}, {'cui': 'C0392220', 'cui_str': 'Scalpel'}]","[{'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0010164', 'cui_str': 'Cosmetic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0013103', 'cui_str': 'Drainage procedure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",60.0,0.0525377,No significant difference was seen in perioperative and postoperative complications between both groups.,"[{'ForeName': 'Praveen Satish', 'Initials': 'PS', 'LastName': 'Kumar', 'Affiliation': 'Department of OMFS, Goa Dental College and Hospital, Bambolim, Goa 403202 India.'}, {'ForeName': 'Edlyn', 'Initials': 'E', 'LastName': 'Rodrigues', 'Affiliation': 'Department of OMFS, Goa Dental College and Hospital, Bambolim, Goa 403202 India.'}, {'ForeName': 'Vikas', 'Initials': 'V', 'LastName': 'Dhupar', 'Affiliation': 'Department of OMFS, Goa Dental College and Hospital, Bambolim, Goa 403202 India.'}, {'ForeName': 'Sthita', 'Initials': 'S', 'LastName': 'Gurrala', 'Affiliation': 'Department of OMFS, Goa Dental College and Hospital, Bambolim, Goa 403202 India.'}]",Journal of maxillofacial and oral surgery,['10.1007/s12663-020-01377-0']
1462,33069881,Efficacy and Safety of Ornithine Phenylacetate for Treating Overt Hepatic Encephalopathy in a Randomized Trial.,"BACKGROUND & AIMS


Hepatic encephalopathy (HE) is associated with increased morbidity, mortality, and healthcare resource use. In this phase 2b study, we evaluated the efficacy and safety of ornithine phenylacetate (OP), an ammonia scavenger, in hospitalized patients with cirrhosis, increased levels of ammonia at screening, and acute or overt HE.
METHODS


We conducted a double-blind study of 231 patients with cirrhosis and HE at multiple sites in North America, Europe, Israel, and Australia from January 7, 2014, through December 29, 2016. Patients were randomly assigned to groups that received placebo or OP (10, 15, or 20 g/day, based on severity of liver disease), plus each institution's standard of care (for example, lactulose to achieve 2-3 bowel movements with or without rifaximin, in accordance with guidelines). The primary endpoint was time to confirmed clinical response, defined as reduction to HE staging tool (HEST) stage 2 from baseline HEST stage 3/4 or improvement to HEST stage 0/1 from baseline stage 2, in the intent to treat population (all patients with increased levels of ammonia at screening, determined by a local laboratory).
RESULTS


Median times to clinical improvement, based on ammonia measurements at local laboratories, did not differ significantly between the groups given OP vs the placebo group (P=.129). Analyses of central laboratory confirmed increases in levels of ammonia at baseline (n=201) revealed a clinical improvement in HE at a median of 21 hours sooner in groups given OP vs placebo. The percentages of patients with any specific adverse event did not differ significantly between groups. Serious adverse events occurred in 25% of patients in the OP group and 29% in the placebo group (P=.552).
CONCLUSIONS


In a randomized controlled trial of patients with cirrhosis and HE, we found no significant difference in time to clinical improvement between patients given OP vs placebo. However, OP appears to be safe and should undergo further testing for treatment of hyperammonemia in hospitalized patients receiving treatment for the underlying precipitant of acute or overt HE. ClinicalTrials.gov no: NCT01966419.",2020,Analyses of central laboratory confirmed increases in levels of ammonia at baseline (n=201) revealed a clinical improvement in HE at a median of 21 hours sooner in groups given OP vs placebo.,"['hospitalized patients with cirrhosis, increased levels of ammonia at screening, and acute or overt HE', '231 patients with cirrhosis and HE at multiple sites in North America, Europe, Israel, and Australia from January 7, 2014, through December 29, 2016', 'hospitalized patients receiving treatment for the underlying precipitant of acute or overt HE', 'patients with cirrhosis and HE']","['placebo or OP', ""institution's standard of care (for example, lactulose to achieve 2-3 bowel movements with or without rifaximin"", 'ornithine phenylacetate (OP', 'Ornithine Phenylacetate', 'placebo']","['time to clinical improvement', 'levels of ammonia', 'time to confirmed clinical response, defined as reduction to HE staging tool (HEST) stage 2 from baseline HEST stage 3/4 or improvement to HEST stage', 'efficacy and safety', 'Serious adverse events', 'Efficacy and Safety', 'clinical improvement in HE', 'morbidity, mortality, and healthcare resource use']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0002607', 'cui_str': 'Ammonia'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0019151', 'cui_str': 'Hepatic encephalopathy'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0022271', 'cui_str': 'Israel'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3492240', 'cui_str': 'ornithine phenylacetate'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0022957', 'cui_str': 'Lactulose'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0073374', 'cui_str': 'rifaximin'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0002607', 'cui_str': 'Ammonia'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0019151', 'cui_str': 'Hepatic encephalopathy'}, {'cui': 'C0332305', 'cui_str': 'With staging'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",231.0,0.642066,Analyses of central laboratory confirmed increases in levels of ammonia at baseline (n=201) revealed a clinical improvement in HE at a median of 21 hours sooner in groups given OP vs placebo.,"[{'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Rahimi', 'Affiliation': 'Baylor Scott and White Hospital, Baylor University Medical Center, Dallas, TX, USA. Electronic address: Robert.Rahimi@bswhealth.org.'}, {'ForeName': 'Rifaat', 'Initials': 'R', 'LastName': 'Safadi', 'Affiliation': 'The Liver Unit, Division of Medicine, Institute of Gastroenterology and Liver Diseases, Hadassah Medical Organization, Hadassah Hebrew University Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Thabut', 'Affiliation': 'Paris Sorbonne Université, Assistance Publique - Hôpitaux de Paris, Brain Liver Pitié-Salpêtrière (B-LIPS) Study Group, Paris, France.'}, {'ForeName': 'Kalyan Ram', 'Initials': 'KR', 'LastName': 'Bhamidimarri', 'Affiliation': 'University of Miami-Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Pyrsopoulos', 'Affiliation': 'Rutgers New Jersey Medical School and University Hospital, Newark, NJ, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Potthoff', 'Affiliation': 'Ocera Therapeutics, Inc., Redwood City, CA, USA (at the time of the study).'}, {'ForeName': 'Stan', 'Initials': 'S', 'LastName': 'Bukofzer', 'Affiliation': 'Ocera Therapeutics, Inc., Redwood City, CA, USA (at the time of the study).'}, {'ForeName': 'Jasmohan S', 'Initials': 'JS', 'LastName': 'Bajaj', 'Affiliation': 'Department of Medicine, Virginia Commonwealth University and McGuire VA Medical Center, Richmond, VA, USA.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2020.10.019']
1463,33069883,OCT signal enhancement with deep learning.,"PURPOSE


To establish whether deep learning methods are able to improve the signal-to-noise ratio of time-domain (TD) optical coherence tomography (OCT) images to approach that of spectral-domain (SD) OCT.
DESIGN


Method agreement study and progression-detection in a randomized, double-masked, placebo-controlled, multi-centre trial for open-angle glaucoma (OAG) [UK Glaucoma Treatment Study (UKGTS)].
PARTICIPANTS


Cohort for training and validation: 77 stable OAG participants with TDOCT and SDOCT imaging at up to 11 visits within 3 months. Cohort for testing: 284 newly-diagnosed OAG patients with TDOCT from a cohort of 516 recruited at 10 UK centres between 2007 and 2010.
METHODS


An ensemble of generative adversarial networks (GANs) was trained on TDOCT and SDOCT image pairs from the training dataset and applied to TDOCT images from the testing dataset. TDOCT were converted to synthesized SDOCT images and segmented via Bayesian fusion on the output of the GANs.
MAIN OUTCOME MEASURES


1) Bland-Altman analysis to assess agreement between TDOCT and synthesized SDOCT average retinal nerve fibre layer thickness (RNFLT) measurements and the SDOCT RNFLT. 2) Analysis of the distribution of the rates of RNFLT change in TDOCT and synthesized SDOCT in the two treatments arms of the UKGTS was compared. A Cox model for predictors of time-to-incident VF progression was computed with the TDOCT and the synthesized SDOCT.
RESULTS


The 95% limits of agreement between TDOCT and SDOCT were [26.64, -22.95], between synthesized SDOCT and SDOCT were [8.11, -6.73], and between SDOCT and SDOCT were [4.16, -4.04]. The mean difference in the rate of RNFL change between UKGTS treatment and placebo arms with TDOCT was 0.24 (p=0.11) and with synthesized SDOCT was 0.43 (p=0.0017). The hazard ratio for RNFLT slope in Cox regression modeling for time to incident VF progression was 1.09 (95% CI 1.02 to 1.21) (p=0.035) for TDOCT and 1.24 (95% CI 1.08 to 1.39) (p=0.011) for synthesized SDOCT.
CONCLUSIONS


Image enhancement significantly improved the agreement of TDOCT RNFLT measurements with SDOCT RNFLT measurements. The difference, and its significance, in rates of RNFLT change in the UKGTS treatment arms was enhanced and RNFLT change became a stronger predictor of VF progression.",2020,"The difference, and its significance, in rates of RNFLT change in the UKGTS treatment arms was enhanced and RNFLT change became a stronger predictor of VF progression.","['Cohort for training and validation: 77 stable OAG participants with TDOCT and SDOCT imaging at up to 11 visits within 3 months', 'Cohort for testing: 284 newly-diagnosed OAG patients with TDOCT from a cohort of 516 recruited at 10 UK centres between 2007 and 2010']",['placebo'],"['OCT signal enhancement', '1) Bland-Altman analysis to assess agreement between TDOCT and synthesized SDOCT average retinal nerve fibre layer thickness (RNFLT) measurements and the SDOCT RNFLT', 'rates of RNFLT change', 'VF progression', 'hazard ratio for RNFLT slope', 'rate of RNFL change']","[{'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0017612', 'cui_str': 'Open-angle glaucoma'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0591126', 'cui_str': 'AT-10'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C1720466', 'cui_str': 'Nerve fiber layer'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",,0.128628,"The difference, and its significance, in rates of RNFLT change in the UKGTS treatment arms was enhanced and RNFLT change became a stronger predictor of VF progression.","[{'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Lazaridis', 'Affiliation': ""NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, United Kingdom; Centre for Medical Image Computing, University College London, London, United Kingdom; School of Biomedical Engineering and Imaging Sciences, King's College London, London, United Kingdom.""}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Lorenzi', 'Affiliation': ""Université Côte d'Azur, Inria Sophia Antipolis, Epione Research Project, France.""}, {'ForeName': 'Jibran', 'Initials': 'J', 'LastName': 'Mohamed-Noriega', 'Affiliation': 'NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, United Kingdom; Departamento de Oftalmología, Hospital Universitario, UANL, México.'}, {'ForeName': 'Soledad', 'Initials': 'S', 'LastName': 'Aguilar-Munoa', 'Affiliation': 'NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, United Kingdom.'}, {'ForeName': 'Katsuyoshi', 'Initials': 'K', 'LastName': 'Suzuki', 'Affiliation': 'NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, United Kingdom.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Nomoto', 'Affiliation': 'NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, United Kingdom.'}, {'ForeName': 'Sebastien', 'Initials': 'S', 'LastName': 'Ourselin', 'Affiliation': ""School of Biomedical Engineering and Imaging Sciences, King's College London, London, United Kingdom.""}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Garway-Heath', 'Affiliation': 'NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Ophthalmology. Glaucoma,['10.1016/j.ogla.2020.10.008']
1464,33069888,Long-Term Overall Survival From KEYNOTE-021 Cohort G: Pemetrexed and Carboplatin With or Without Pembrolizumab as First-Line Therapy for Advanced Nonsquamous NSCLC.,"INTRODUCTION


In cohort G of KEYNOTE-021 (NCT02039674), first-line pembrolizumab plus pemetrexed-carboplatin significantly improved the objective response rate and progression-free survival versus chemotherapy alone with manageable toxicity in advanced nonsquamous NSCLC. We report the long-term outcomes from this study.
METHODS


Patients with previously untreated advanced nonsquamous NSCLC without sensitizing EGFR or ALK alterations were randomly assigned 1:1 to receive open-label pemetrexed 500 mg/m 2  plus carboplatin at area under the concentration-time curve of 5 mg/mL/min (four cycles) with or without pembrolizumab 200 mg (up to 2 years), with optional pemetrexed maintenance, each administered every 3 weeks. Eligible patients could crossover from the chemotherapy arm to pembrolizumab monotherapy after progression. Responses were assessed per the Response Evaluation Criteria in Solid Tumors version 1.1.
RESULTS


After the median time of 49.4 months from randomization to data cutoff, objective response rate (58% versus 33%) and progression-free survival (median: 24.5 versus 9.9 mo; hazard ratio: 0.54; 95% confidence interval: 0.35‒0.83) remained improved with pembrolizumab combination (n = 60) versus chemotherapy (n = 63), regardless of programmed death ligand 1 status. Median overall survival was 34.5 versus 21.1 months (hazard ratio: 0.71; 95% confidence interval: 0.45‒1.12), despite a 70% crossover rate from chemotherapy alone to anti‒programmed death (ligand) 1 therapy. Among the 12 patients who completed 2 years of pembrolizumab, 92% were alive at data cutoff; the estimated 3-year duration of response rate was 100%. Grade 3 to 5 treatment-related adverse events occurred in 39% of patients receiving pembrolizumab combination and 31% receiving chemotherapy.
CONCLUSIONS


First-line pembrolizumab plus pemetrexed-carboplatin continued to show improved response and survival versus chemotherapy alone in advanced nonsquamous NSCLC, with durable clinical benefit in patients who completed 2 years of therapy. No new safety signals were observed with longer follow-up.",2020,"Median OS was 34.5 versus 21.1 months (HR, 0.71; 95%CI, 0.45‒1.12), despite a 70% crossover rate from chemotherapy alone to anti‒PD-(L)1 therapy.","['advanced nonsquamous non‒small-cell lung cancer (NSCLC', 'Patients with previously untreated advanced nonsquamous NSCLC without sensitizing EGFR/ALK alterations', 'Advanced Nonsquamous Non-Small-Cell Lung Cancer']","['pembrolizumab combination', 'pembrolizumab', 'pembrolizumab plus pemetrexed-carboplatin', 'open-label pemetrexed 500 mg/m 2  plus carboplatin AUC 5 mg/mL/min (4 cycles) with or without pembrolizumab', 'pembrolizumab monotherapy', 'Pemetrexed and Carboplatin With or Without Pembrolizumab', 'chemotherapy']","['response and survival', 'adverse events', 'PFS', 'Median OS', '3-year DOR rate', 'objective response rate (ORR) and progression-free survival (PFS']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C1663627', 'cui_str': 'ALK protein, human'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0439294', 'cui_str': 'g/L'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0140057', 'cui_str': 'delta Opioid Receptor'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]",,0.218764,"Median OS was 34.5 versus 21.1 months (HR, 0.71; 95%CI, 0.45‒1.12), despite a 70% crossover rate from chemotherapy alone to anti‒PD-(L)1 therapy.","[{'ForeName': 'Mark M', 'Initials': 'MM', 'LastName': 'Awad', 'Affiliation': 'Medical Oncology, Lowe Center for Thoracic Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts. Electronic address: mark_awad@dfci.harvard.edu.'}, {'ForeName': 'Shirish M', 'Initials': 'SM', 'LastName': 'Gadgeel', 'Affiliation': 'Thoracic Oncology, Karmanos Cancer Institute, Wayne State University, Detroit, Michigan.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Borghaei', 'Affiliation': 'Hematology and Oncology, Fox Chase Cancer Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Amita', 'Initials': 'A', 'LastName': 'Patnaik', 'Affiliation': 'Clinical Research, START Center for Cancer Care, San Antonio, Texas.'}, {'ForeName': 'James Chih-Hsin', 'Initials': 'JC', 'LastName': 'Yang', 'Affiliation': 'Department of Oncology, National Taiwan University Hospital and National Taiwan University Cancer Center, Taipei, Republic of China.'}, {'ForeName': 'Steven F', 'Initials': 'SF', 'LastName': 'Powell', 'Affiliation': 'Oncology, Sanford Health, Sioux Falls, South Dakota.'}, {'ForeName': 'Ryan D', 'Initials': 'RD', 'LastName': 'Gentzler', 'Affiliation': 'Hematology/Oncology, University of Virginia Cancer Center, Charlottesville, Virginia.'}, {'ForeName': 'Renato G', 'Initials': 'RG', 'LastName': 'Martins', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, Washington.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Stevenson', 'Affiliation': 'Taussig Cancer Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Altan', 'Affiliation': 'Thoracic/Head and Neck Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Shadia I', 'Initials': 'SI', 'LastName': 'Jalal', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Panwalkar', 'Affiliation': 'Hematology/Oncology, Sanford Roger Maris Cancer Center, Fargo, North Dakota.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Gubens', 'Affiliation': 'Medical Oncology, University of California San Francisco, San Francisco, California.'}, {'ForeName': 'Lecia V', 'Initials': 'LV', 'LastName': 'Sequist', 'Affiliation': 'Hematology/Oncology, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Sanatan', 'Initials': 'S', 'LastName': 'Saraf', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Zhao', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Bilal', 'Initials': 'B', 'LastName': 'Piperdi', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Corey J', 'Initials': 'CJ', 'LastName': 'Langer', 'Affiliation': 'Department of Medicine, Abramson Cancer Center, University of Pennsylvania, Philadelphia, Pennsylvania.'}]",Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer,['10.1016/j.jtho.2020.09.015']
1465,33069970,Labor neuraxial analgesia and breastfeeding: An updated systematic review.,"INTRODUCTION


There have been numerous reports studying the effect of neuraxial analgesia on breastfeeding success, but the results are inconsistent.
METHODS


We performed a literature search in various databases for studies comparing neuraxial analgesia to non-neuraxial or no analgesia. Outcomes were the percentage of women breastfeeding fully or mixed with formula. Where possible, nulliparous parturients were analyzed separately. We conducted an analysis excluding studies of serious and critical risk of bias. Odds ratios and 95% confidence intervals were calculated.
RESULTS


We included 15 studies (13 observational studies, 1 secondary analysis of a randomized controlled trial, 1 case-control study) with 16,112 participants. Overall, there were 6 studies that found no difference between groups, 6 studies that showed a significantly lower incidence of breastfeeding in the neuraxial group and 3 studies finding mixed results (at some time-points statistically significant and at some time-point statistically non-significant results). In nulliparous only studies, 2 found no difference between study groups, 1 found a lower breastfeeding rate in the neuraxial group and 3 studies showed mixed results. Excluding studies with a serious and critical risk of bias, 1 study found no difference between study groups, 3 studies found a decrease of breastfeeding rates in the neuraxial group, and 1 study showed mixed results.
DISCUSSION


In our review we found a high disparity in results. One reason is probably the high potential of confounding (immediate skin to skin placement, maternity leave etc.). Education programs and breastfeeding support are likely more important in determining long term breastfeeding success.",2020,"Overall, there were 6 studies that found no difference between groups, 6 studies that showed a significantly lower incidence of breastfeeding in the neuraxial group and 3 studies finding mixed results (at some time-points statistically significant and at some time-point statistically non-significant results).","['nulliparous parturients', '15 studies (13 observational studies, 1 secondary analysis of a randomized controlled trial, 1 case-control study) with 16,112 participants']",['Labor neuraxial analgesia and breastfeeding'],"['breastfeeding rates', 'incidence of breastfeeding', 'breastfeeding rate']","[{'cui': 'C0425979', 'cui_str': 'Nulliparous'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1518527', 'cui_str': 'Observational Study'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0007328', 'cui_str': 'Case Control Studies'}]","[{'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}]","[{'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",16112.0,0.0676764,"Overall, there were 6 studies that found no difference between groups, 6 studies that showed a significantly lower incidence of breastfeeding in the neuraxial group and 3 studies finding mixed results (at some time-points statistically significant and at some time-point statistically non-significant results).","[{'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Heesen', 'Affiliation': 'Faculty of Medicine, University of Zurich, Winterthurerstrasse 190, 8057 Zurich, Switzerland. Electronic address: heesenphilip99@gmail.com.'}, {'ForeName': 'Stephen H', 'Initials': 'SH', 'LastName': 'Halpern', 'Affiliation': 'Department of Anesthesia, University of Toronto and Sunnybrook Health Sciences Centre, 2075 Bayview Avenue, Toronto, Ontario M4N 3M5, Canada. Electronic address: stephen.halpern@sunnybrook.ca.'}, {'ForeName': 'Yaakov', 'Initials': 'Y', 'LastName': 'Beilin', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, and Obstetrics, Gynecology and Reproductive Sciences, Icahn School of Medicine at Mount Sinai, 1468 Madison Avenue, New York, NY 10029, USA. Electronic address: yaakov.beilin@mountsinai.org.'}, {'ForeName': 'Paola A', 'Initials': 'PA', 'LastName': 'Mauri', 'Affiliation': ""School of Midwifery, Department of Clinical Sciences and Community Health, Università degli Studi di Milano, Via della Commenda 19, 20122 Milano, Italy; Department of Mother Child and Newborn Health, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Italy. Electronic address: paola.mauri@unimi.it.""}, {'ForeName': 'Leonid A', 'Initials': 'LA', 'LastName': 'Eidelman', 'Affiliation': 'Department of Anesthesia, Rabin Medical Center, Beilinson Hospital, Zeev Jabutinskiy Rd 39, Petah Tikva 49100, Israel. Electronic address: leidelman@clalit.org.il.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Heesen', 'Affiliation': 'Department of Anesthesia, Kantonsspital Baden, Im Ergel 1, 5404 Baden, Switzerland. Electronic address: michael.heesen@ksb.ch.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Orbach-Zinger', 'Affiliation': 'Department of Anesthesia, Rabin Medical Center, Beilinson Hospital, Zeev Jabutinskiy Rd 39, Petah Tikva 49100, Israel. Electronic address: sharonorbach@yahoo.com.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.110105']
1466,33069972,Efficacy of prothrombin complex concentrate for reversal of major bleeding due to rivaroxaban: A pilot randomized controlled trial.,,2020,,[],"['rivaroxaban', 'prothrombin complex concentrate']",[],[],"[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C4048712', 'cui_str': 'factor IX complex'}]",[],,0.158675,,"[{'ForeName': 'Kamran', 'Initials': 'K', 'LastName': 'Shadvar', 'Affiliation': 'Department of Anesthesiology and intensive care medicine, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Pariya', 'Initials': 'P', 'LastName': 'Sadaghi', 'Affiliation': 'Department of Anesthesiology and intensive care medicine, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Hadi', 'Initials': 'H', 'LastName': 'Hamishekar', 'Affiliation': 'Department of Clinical Pharmacy, Faculty of Pharmacy, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Ata', 'Initials': 'A', 'LastName': 'Mahmoodpoor', 'Affiliation': 'Department of Anesthesiology and intensive care medicine, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: amahmoodpoor@yahoo.com.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.110093']
1467,33070009,A trial of buspirone for anxiety in Parkinson's disease: Safety and tolerability.,"INTRODUCTION


In Parkinson's disease (PD), anxiety is common, associated with lower health-related quality of life, and undertreated. The primary objective of this study was to determine the tolerability of buspirone for the treatment of anxiety in PD.
METHODS


Individuals with PD and clinically significant anxiety were randomized 4:1 to flexible dosage buspirone or placebo for 12 weeks. Treatment was initiated at 7.5 mg twice daily and titrated based on response and tolerability to an optimal dosage (maximum 30 mg twice daily). The primary outcome was the proportion of participants who failed to complete the study on study drug. Secondary outcomes included adverse events, dosage reductions, motor function, dyskinesias, and anxiety.
RESULTS


A total of 21 participants enrolled, 4 were randomized to placebo and 17 to buspirone (mean (SD) age 65.5 (9.8), 76.5% male, 88% on concomitant antidepressant or anxiolytic). In the buspirone group, 7 (41%) failed to complete the study on drug, 5 due to intolerability. The median buspirone dosage was 7.5 mg twice daily. No serious adverse events occurred. A total of 9 (53%) buspirone participants experienced adverse events consistent with worsened motor function. In the buspirone group, mean (SD) improvement from baseline to week 12 in Hamilton Anxiety Rating Scale was -3.9 (3.8) and Parkinson Anxiety Scale -7.1 (6.4).
CONCLUSION


Tolerability concerns do not support moving immediately forward with a large-scale efficacy trial. However, concomitant anxiolytics may have affected tolerability and a signal of efficacy was seen suggesting that future studies of buspirone monotherapy be considered.",2020,"In the buspirone group, mean (SD) improvement from baseline to week 12 in Hamilton Anxiety Rating Scale was -3.9 (3.8) and Parkinson Anxiety Scale -7.1 (6.4).
","[""Parkinson's disease"", 'Individuals with PD and clinically significant anxiety', 'mean (SD) age 65.5 (9.8), 76.5% male, 88% on concomitant antidepressant or anxiolytic', 'A total of 21 participants enrolled, 4 were randomized to']","['flexible dosage buspirone or placebo', 'placebo', 'buspirone']","['Parkinson Anxiety Scale', 'adverse events', 'tolerability', 'Hamilton Anxiety Rating Scale', 'adverse events, dosage reductions, motor function, dyskinesias, and anxiety']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0040616', 'cui_str': 'Anxiolytic agent'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0006462', 'cui_str': 'Buspirone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0013384', 'cui_str': 'Dyskinesia'}]",21.0,0.0671081,"In the buspirone group, mean (SD) improvement from baseline to week 12 in Hamilton Anxiety Rating Scale was -3.9 (3.8) and Parkinson Anxiety Scale -7.1 (6.4).
","[{'ForeName': 'Ruth B', 'Initials': 'RB', 'LastName': 'Schneider', 'Affiliation': 'Department of Neurology, University of Rochester School of Medicine and Dentistry, 265 Crittenden Blvd, Box MIND, Rochester, NY, 14642, USA. Electronic address: ruth_schneider@urmc.rochester.edu.'}, {'ForeName': 'Peggy', 'Initials': 'P', 'LastName': 'Auinger', 'Affiliation': 'Center for Health and Technology, University of Rochester School of Medicine and Dentistry, 265 Crittenden Blvd, Box 694, Rochester, NY, USA. Electronic address: peggy.auinger@chet.rochester.edu.'}, {'ForeName': 'Christopher G', 'Initials': 'CG', 'LastName': 'Tarolli', 'Affiliation': 'Department of Neurology, University of Rochester School of Medicine and Dentistry, 265 Crittenden Blvd, Box MIND, Rochester, NY, 14642, USA. Electronic address: christopher_tarolli@urmc.rochester.edu.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Iourinets', 'Affiliation': 'Department of Neurology, University of Rochester School of Medicine and Dentistry, 919 Westfall Rd, Building C, Suite 100, Rochester, NY, 14618, USA. Electronic address: jiourine@u.rochester.edu.'}, {'ForeName': 'María Cristina', 'Initials': 'MC', 'LastName': 'Gil-Díaz', 'Affiliation': 'Department of Neuroscience, University of Rochester, 500 Joseph C. Wilson Blvd, Rochester, NY, 14627, USA. Electronic address: mgildiaz@u.rochester.edu.'}, {'ForeName': 'Irene H', 'Initials': 'IH', 'LastName': 'Richard', 'Affiliation': 'Department of Neurology, University of Rochester School of Medicine and Dentistry, 919 Westfall Rd, Building C, Suite 100, Rochester, NY, 14618, USA. Electronic address: irene_richard@urmc.rochester.edu.'}]",Parkinsonism & related disorders,['10.1016/j.parkreldis.2020.10.020']
1468,33070045,Effects of a light therapy intervention on diurnal salivary cortisol in fatigued cancer survivors: A secondary analysis of a randomized controlled trial.,"OBJECTIVE


Altered diurnal cortisol rhythms are a potential mechanism through which symptoms of fatigue are maintained in post-treatment cancer survivors. Exposure to early morning bright light may target this underlying dysregulation, resulting in improved diurnal cortisol patterns, subsequently improving symptoms of fatigue. This research investigates the effects of a 4-week light therapy intervention on the diurnal cortisol slopes and output in fatigued cancer survivors.
METHODS


Post-treatment adult cancer survivors who met diagnostic criteria for cancer-related fatigue were randomly assigned to receive either a bright white light (BWL) or dim red light (DRL) device, used daily for 30 min over four consecutive weeks. Assessments of fatigue and salivary cortisol were collected at baseline and post-intervention. Cortisol was sampled four times per day (waking, noon, 5 pm, bedtime) for three days at each timepoint. Diurnal cortisol slopes and total cortisol output were calculated at baseline and post-intervention. Linear mixed models were used to analyze the data.
RESULTS


Seventy-seven participants were included in this analysis (BWL n = 40; DRL n = 37). Participants in both groups displayed increased steepness in cortisol slope (B = -0.02, p = .01, Cohen's d = 0.57) and increased total cortisol output (B = 9.58, p = .03, Cohen's d = 0.49) from baseline to post-intervention, indicating only a moderate effect of time. Neither diurnal cortisol slopes nor total cortisol output mediated the relationship between the light therapy intervention and fatigue levels.
CONCLUSION


Though the results of this trial are promising for light therapy as an effective intervention to reduce fatigue in cancer survivors, this does not appear to be achieved through alterations in neuroendocrine function. ClinicalTrials.gov registration #: NCT01780623.",2020,"Participants in both groups displayed increased steepness in cortisol slope (B = -0.02, p = .01,","['Seventy-seven participants', 'cancer survivors', 'Post-treatment adult cancer survivors who met diagnostic criteria for cancer-related fatigue', 'fatigued cancer survivors']","['light therapy intervention', 'bright white light (BWL) or dim red light (DRL) device']","['diurnal cortisol slopes nor total cortisol output', 'Diurnal cortisol slopes and total cortisol output', 'total cortisol output', 'steepness in cortisol slope', 'fatigue and salivary cortisol', 'diurnal salivary cortisol', 'diurnal cortisol slopes']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C4274302', 'cui_str': 'Cancer-related fatigue'}]","[{'cui': 'C0031765', 'cui_str': 'Light therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0423899', 'cui_str': 'Above average intellect'}, {'cui': 'C0563228', 'cui_str': 'White light'}, {'cui': 'C0114346', 'cui_str': 'dimesna'}, {'cui': 'C0563227', 'cui_str': 'Red light'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}]",77.0,0.241495,"Participants in both groups displayed increased steepness in cortisol slope (B = -0.02, p = .01,","[{'ForeName': 'Jillian A', 'Initials': 'JA', 'LastName': 'Johnson', 'Affiliation': 'Department of Biobehavioral Health, Pennsylvania State University, State College, PA, USA. Electronic address: jaj53@psu.edu.'}, {'ForeName': 'Utkarsh', 'Initials': 'U', 'LastName': 'Subnis', 'Affiliation': 'Department of Oncology and Division of Psychosocial Oncology, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada. Electronic address: utkarsh.subnis@ucalgary.ca.'}, {'ForeName': 'Linda E', 'Initials': 'LE', 'LastName': 'Carlson', 'Affiliation': 'Department of Oncology and Division of Psychosocial Oncology, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada; Department of Psychology, University of Calgary, Calgary, AB, Canada. Electronic address: lcarlso@ucalgary.ca.'}, {'ForeName': 'Sheila N', 'Initials': 'SN', 'LastName': 'Garland', 'Affiliation': ""Departments of Psychology and Oncology, Memorial University, St. John's, Newfoundland, Canada. Electronic address: sheila.garland@mun.ca.""}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Santos-Iglesias', 'Affiliation': 'Department of Psychology, Cape Breton University, Sydney, NS, Canada. Electronic address: pablo_santos@cbu.ca.'}, {'ForeName': 'Katherine-Ann L', 'Initials': 'KL', 'LastName': 'Piedalue', 'Affiliation': 'Department of Oncology and Division of Psychosocial Oncology, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada. Electronic address: klpiedal@ucalgary.ca.'}, {'ForeName': 'Julie M', 'Initials': 'JM', 'LastName': 'Deleemans', 'Affiliation': 'Department of Oncology and Division of Psychosocial Oncology, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada; Division of Medical Science, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada. Electronic address: julie.deleemans@ucalgary.ca.'}, {'ForeName': 'Tavis S', 'Initials': 'TS', 'LastName': 'Campbell', 'Affiliation': 'Department of Oncology and Division of Psychosocial Oncology, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada; Department of Psychology, University of Calgary, Calgary, AB, Canada. Electronic address: t.s.campbell@ucalgary.ca.'}]",Journal of psychosomatic research,['10.1016/j.jpsychores.2020.110266']
1469,33070053,"Combination of gefitinib and olaparib versus gefitinib alone in EGFR mutant non-small-cell lung cancer (NSCLC): A multicenter, randomized phase II study (GOAL).","OBJECTIVES


Progression-free survival (PFS) and response rate to epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) varies in patients with non-small-cell lung cancer (NSCLC) driven byEGFR mutations, suggesting that other genetic alterations may influence oncogene addiction. Low BRCA1 mRNA levels correlate with longer PFS in erlotinib-treated EGFR-mutant NSCLC patients. Since the poly (ADP-ribose) polymerase (PARP) inhibitor, olaparib, may attenuate and/or prevent BRCA1 expression, the addition of olaparib to gefitinib could improve outcome in EGFR-mutant advanced NSCLC.
MATERIALS AND METHODS


GOAL was a multicenter, randomized phase IB/II study performed in two countries, Spain and Mexico. Eligible patients were 18 years or older, treatment-naïve, pathologically confirmed stage IV NSCLC, with centrally confirmed EGFR mutations and measurable disease. Patients were randomly allocated (1:1) to receive gefitinib 250 mg daily or gefitinib 250 mg daily plus olaparib 200 mg three times daily in 28-day cycles. The primary endpoint was PFS. Secondary endpoints included overall survival (OS), response rate, safety and tolerability.
RESULTS


Between September 2013, and July 2016, 182 patients underwent randomization, 91 received gefitinib and 91 received gefitinib plus olaparib. There were no differences in gender, age, smoking status, performance status, presence of bone and brain metastases or type ofEGFR mutation. Median PFS was 10.9 months (95 % CI 9.3-13.3) in the gefitinib arm and 12.8 months (95 % CI 9.1-14.7) in the gefitinib plus olaparib arm (HR 1.38, 95 % CI 1.00-1.92; p = 0.124). The most common adverse events were anemia, 78 % in gefitinib plus olaparib group, 38 % in gefitinib arm, diarrhea, 65 % and 60 %, and fatigue, 40 % and 32 %, respectively.
CONCLUSIONS


The gefitinib plus olaparib combination did not provide significant benefit over gefitinib alone. The combination's safety profile showed an increase in hematological and gastrointestinal toxicity, compared to gefitinib alone, however, no relevant adverse events were noted.",2020,"The combination's safety profile showed an increase in hematological and gastrointestinal toxicity, compared to gefitinib alone, however, no relevant adverse events were noted.","['182 patients underwent randomization, 91 received', 'Between September 2013, and July 2016', 'patients with non-small-cell lung cancer (NSCLC) driven byEGFR mutations', 'two countries, Spain and Mexico', 'EGFR mutant non-small-cell lung cancer (NSCLC', 'Eligible patients were 18 years or older, treatment-naïve, pathologically confirmed stage IV NSCLC, with centrally confirmed EGFR mutations and measurable disease']","['gefitinib 250\u202fmg daily or gefitinib 250\u202fmg daily plus olaparib 200\u202fmg three times daily in 28-day cycles', 'epidermal growth factor receptor', 'EGFR) tyrosine kinase inhibitors (TKIs', 'gefitinib', 'gefitinib plus olaparib', 'gefitinib and olaparib versus gefitinib alone']","['diarrhea', 'Median PFS', 'hematological and gastrointestinal toxicity', 'PFS', 'overall survival (OS), response rate, safety and tolerability', 'gender, age, smoking status, performance status, presence of bone and brain metastases or type ofEGFR mutation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0025885', 'cui_str': 'Mexico'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0278987', 'cui_str': 'Metastatic non-small cell lung cancer'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C1176914', 'cui_str': 'gefitinib 250 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2316164', 'cui_str': 'olaparib'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0556984', 'cui_str': 'Three times daily'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C1268567', 'cui_str': 'Protein-tyrosine kinase inhibitor'}, {'cui': 'C1122962', 'cui_str': 'gefitinib'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1142499', 'cui_str': 'Gastrointestinal toxicity'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0220650', 'cui_str': 'Secondary malignant neoplasm of brain'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}]",182.0,0.184564,"The combination's safety profile showed an increase in hematological and gastrointestinal toxicity, compared to gefitinib alone, however, no relevant adverse events were noted.","[{'ForeName': 'Rosario', 'Initials': 'R', 'LastName': 'Garcia-Campelo', 'Affiliation': 'University Hospital A Coruña (XXIAC-SERGAS), A Coruña, Spain.'}, {'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Arrieta', 'Affiliation': 'Instituto Nacional de Cancerología, Mexico City, Mexico.'}, {'ForeName': 'Bartomeu', 'Initials': 'B', 'LastName': 'Massuti', 'Affiliation': 'Alicante University Hospital, Alicante, Spain.'}, {'ForeName': 'Delvys', 'Initials': 'D', 'LastName': 'Rodriguez-Abreu', 'Affiliation': 'Hospital Universitario Insular De Gran Canaria, Las Palmas, Spain.'}, {'ForeName': 'Ana Laura Ortega', 'Initials': 'ALO', 'LastName': 'Granados', 'Affiliation': 'Complejo Hospitalario de Jaén, Jaén, Spain.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Majem', 'Affiliation': 'Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Vicente', 'Affiliation': 'Hospital Universitario Virgen Macarena, Seville, Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Lianes', 'Affiliation': 'Hospital de Mataró, Mataró, Spain.'}, {'ForeName': 'Joaquim', 'Initials': 'J', 'LastName': 'Bosch-Barrera', 'Affiliation': 'Catalan Institute of Oncology (ICO) and Girona Biomedical Research Institute (IDIBGi), Girona, Spain.'}, {'ForeName': 'Amelia', 'Initials': 'A', 'LastName': 'Insa', 'Affiliation': 'Hospital Clínico Universitario de Valencia, Valencia, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Dómine', 'Affiliation': 'Hospital Universitario Fundación Jimenez Diaz, Madrid, Spain.'}, {'ForeName': 'Noemí', 'Initials': 'N', 'LastName': 'Reguart', 'Affiliation': ""Hospital Clínic Barcelona, Barcelona, Spain; Translational Genomics and Targeted Therapeutics in Solid Tumors, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.""}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Guirado', 'Affiliation': 'Hospital General de Elche, Elche, Alicante, Spain.'}, {'ForeName': 'María Ángeles', 'Initials': 'MÁ', 'LastName': 'Sala', 'Affiliation': 'Hospital Universitario de Basurto, Bilbao, Spain.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Vázquez-Estevez', 'Affiliation': 'Hospital Universitario Lucus Augusti, Lugo, Spain.'}, {'ForeName': 'Reyes Bernabé', 'Initials': 'RB', 'LastName': 'Caro', 'Affiliation': 'Hospital Virgen Del Rocio, Sevilla, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Drozdowskyj', 'Affiliation': 'Germans Trias i Pujol Research Institute and Hospital (IGTP), Badalona, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Verdú', 'Affiliation': 'Spanish Lung Cancer Group Office, Barcelona, Spain.'}, {'ForeName': 'Niki', 'Initials': 'N', 'LastName': 'Karachaliou', 'Affiliation': 'Laboratory of Oncology/Pangaea Oncology, Quiron Dexeus University Hospital, Barcelona, Spain.'}, {'ForeName': 'Miguel Angel', 'Initials': 'MA', 'LastName': 'Molina-Vila', 'Affiliation': 'Laboratory of Oncology/Pangaea Oncology, Quiron Dexeus University Hospital, Barcelona, Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Rosell', 'Affiliation': 'Germans Trias i Pujol Research Institute and Hospital (IGTP), Badalona, Spain. Electronic address: rrosell@iconcologia.net.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lung cancer (Amsterdam, Netherlands)",['10.1016/j.lungcan.2020.09.018']
1470,33070057,Salivary measurement and mindfulness-based modulation of prescription opioid cue-reactivity.,"BACKGROUND


Chronic pain patients on long-term opioid therapy (LTOT) may be at elevated risk for developing conditioned opioid cue-reactivity as their prescribed dosing schedules simultaneously function as fixed reinforcement schedules. Since opioids are typically consumed orally during LTOT, it stands to reason that opioid cue exposure might elicit conditioned salivary responses. However, no study has examined salivary cue-reactivity among opioid users during in-vivo exposure to their own prescription opioid medication.
METHODS


Two samples (N = 68, N = 39) of chronic pain patients on LTOT were recruited from primary care and specialty care clinics. Study 1 aimed to determine whether chronic pain patients receiving LTOT exhibited salivary cue-reactivity to their prescribed opioid. Study 2 was a pilot study that aimed to assess the effects of behavioral treatment on chronic pain patients' salivary cue-reactivity.
RESULTS


In Study 1, exposure to the patient's own prescribed opioid resulted in significantly greater increases in salivation and cue-elicited craving than exposure to a neutral cue. In Study 2 participants who were randomized to an 8-week Mindfulness-Oriented Recovery Enhancement intervention evidenced significantly greater decreases in opioid cue-reactivity than participants in an active control condition as evidenced by both reduced salivation and craving ratings.
CONCLUSIONS


Study findings demonstrate salivation may serve as a useful, objective index of opioid cue-reactivity. With further refinement of this task, conditioned salivary response could be used to identify especially vulnerable patients, who then could be targeted with a personalized medicine approach for selective and intensive prevention/treatment interventions to preempt escalation of opioid use to opioid misuse and OUD.",2020,"In Study 2 participants who were randomized to an 8-week Mindfulness-Oriented Recovery Enhancement intervention evidenced significantly greater decreases in opioid cue-reactivity than participants in an active control condition as evidenced by both reduced salivation and craving ratings.
","['chronic pain patients receiving LTOT exhibited salivary cue-reactivity to their prescribed opioid', 'Chronic pain patients on long-term', ""chronic pain patients' salivary cue-reactivity"", 'Two samples (N = 68, N = 39) of chronic pain patients on LTOT were recruited from primary care and specialty care clinics']","['8-week Mindfulness-Oriented Recovery Enhancement intervention', 'behavioral treatment', 'opioid therapy (LTOT']","['salivation and cue-elicited craving', 'opioid cue-reactivity', 'salivation and craving ratings']","[{'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0015272', 'cui_str': 'Exhibits as Topic'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0037778', 'cui_str': 'Medical specialty'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]","[{'cui': 'C0036104', 'cui_str': 'Salivary secretion'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0449265', 'cui_str': 'Elicited by'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}]",2.0,0.0378235,"In Study 2 participants who were randomized to an 8-week Mindfulness-Oriented Recovery Enhancement intervention evidenced significantly greater decreases in opioid cue-reactivity than participants in an active control condition as evidenced by both reduced salivation and craving ratings.
","[{'ForeName': 'Adam W', 'Initials': 'AW', 'LastName': 'Hanley', 'Affiliation': 'Center on Mindfulness and Integrative Health Intervention Development, University of Utah, United States; College of Social Work, University of Utah, United States.'}, {'ForeName': 'Eric L', 'Initials': 'EL', 'LastName': 'Garland', 'Affiliation': 'Center on Mindfulness and Integrative Health Intervention Development, University of Utah, United States; College of Social Work, University of Utah, United States; Salt Lake City Veterans Administration Medical Center, United States. Electronic address: eric.garland@socwk.utah.edu.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108351']
1471,33070132,"Influence of Simvastatin as Augmentative Therapy in the Treatment of Generalized Anxiety Disorder: A Pilot Randomized, Placebo-Controlled Study.","BACKGROUND


Preliminary evidence is promising regarding the anxiolytic effects of statins in animal models of anxiety. Hence, this study aimed to evaluate the efficacy of simvastatin augmentation versus placebo in the treatment of patients with generalized anxiety disorder (GAD) with residual symptoms despite treatment with selective serotonin reuptake inhibitors (SSRIs).
METHODS


A double-blind, 8-week controlled trial was conducted from August 2018 to December 2019 in an outpatient psychiatry clinic in Hamadan, Iran. A total of 138 patients with a diagnosis of GAD were assessed for eligibility. Of them, 84 patients who met the study criteria were randomly assigned either to the adjuvant simvastatin (20 mg/day) or to the placebo group. Standard medication consisting of SSRIs was consistent 2 months prior to and during the study. The severity of anxiety symptoms for each patient was assessed based on the Hamilton Anxiety Rating Scale (HAM-A) score at baseline, week 4, and week 8 after treatment. Additionally, blood lipid values were assessed at baseline and on completion of the study.
RESULTS


Thirty-three out of 42 patients in the intervention group and 35 out of 42 patients in the control group completed the 8 weeks of the study period. Compared to the placebo group, in the simvastatin group cholesterol, triglycerides, and low-density lipoprotein significantly decreased, and high-density lipoprotein significantly increased over time. General linear model analysis demonstrated that although over time a higher decrease in mean HAM-A scores was observed in the intervention group compared to the control group, this difference was not statistically significant (p = 0.11). In addition, at the end of the study, the number of responders and remitters was comparable in the two groups.
CONCLUSIONS


The results from this clinical study did not support the potential efficacy of adjunctive simvastatin in the treatment of patients with GAD. Thus, large-scale and long-term clinical trials are required to more accurately assess the potential efficacy of statins in the treatment of patients with anxiety disorders.",2020,"General linear model analysis demonstrated that although over time a higher decrease in mean HAM-A scores was observed in the intervention group compared to the control group, this difference was not statistically significant (p = 0.11).","['patients with GAD', '84 patients who met the study criteria', 'Thirty-three out of 42 patients in the intervention group and 35 out of 42 patients', '138 patients with a diagnosis of GAD', 'patients with generalized anxiety disorder (GAD) with residual symptoms despite treatment with selective serotonin reuptake inhibitors (SSRIs', 'patients with anxiety disorders', 'August 2018 to December 2019 in an outpatient psychiatry clinic in Hamadan, Iran', 'Generalized Anxiety Disorder']","['adjunctive simvastatin', 'adjuvant simvastatin', 'simvastatin augmentation versus placebo', 'simvastatin', 'placebo', 'Simvastatin', 'Placebo']","['mean HAM-A scores', 'blood lipid values', 'Hamilton Anxiety Rating Scale (HAM-A) score', 'severity of anxiety symptoms', 'cholesterol, triglycerides, and low-density lipoprotein', 'high-density lipoprotein']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0360105', 'cui_str': 'Selective serotonin re-uptake inhibitor'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C3811913', 'cui_str': 'Psychiatry clinic'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0074554', 'cui_str': 'Simvastatin'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}]",138.0,0.0318887,"General linear model analysis demonstrated that although over time a higher decrease in mean HAM-A scores was observed in the intervention group compared to the control group, this difference was not statistically significant (p = 0.11).","[{'ForeName': 'Ehsan', 'Initials': 'E', 'LastName': 'Mirzaei', 'Affiliation': 'Department of Clinical Pharmacy, School of Pharmacy, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mahtabalsadat', 'Initials': 'M', 'LastName': 'Mirjalili', 'Affiliation': 'Department of Clinical Pharmacy, School of Pharmacy, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Jahangard', 'Affiliation': 'Research Center for Behavioral Disorders and Substance Abuse, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Haghighi', 'Affiliation': 'Research Center for Behavioral Disorders and Substance Abuse, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Yasrebifar', 'Affiliation': 'Department of Clinical Pharmacy, School of Pharmacy, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Younes', 'Initials': 'Y', 'LastName': 'Mohammadi', 'Affiliation': 'Modeling of Noncommunicable Diseases Research Center, School of Public Health, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Larki-Harchagani', 'Affiliation': 'Department of Toxicology and Pharmacology, School of Pharmacy, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Mehrpooya', 'Affiliation': 'Department of Clinical Pharmacy, School of Pharmacy, Hamadan University of Medical Sciences, Hamadan, Iran, m_mehrpooya2003@yahoo.com.'}]",Neuropsychobiology,['10.1159/000510853']
1472,33070152,"""Fenofibrate as an adjuvant to phototherapy in pathological unconjugated hyperbilirubinemia in neonates: a randomized control trial.""","BACKGROUND


Despite widespread phototherapy usage, many new-born infants remain in need of other invasive lines of therapy, such as intravenous immunoglobulins and exchange transfusions.
OBJECTIVE


Assessment of the efficacy and the safety of adding fenofibrate to phototherapy for the treatment of pathological jaundice in full-term infants.
DESIGN/METHODS


We conducted a double blinded randomized control study on 180 full-term infants with pathological unconjugated hyperbilirubinemia admitted to the NICU at Mansoura University Children's Hospital. They were randomly assigned to receive either oral fenofibrate 10 mg/kg/day for 1 day or 2 days or placebo in addition to phototherapy. The primary outcome was total serum bilirubin values after 12, 24, 36, 48, and 72 h from intervention. Secondary outcomes were total duration of treatment, need for exchange transfusions and intravenous immunoglobulin, exclusive breast-feeding on discharge, and adverse effects of fenofibrate. This study was registered at www.clinicaltrials.gov (NCT04418180).
RESULTS


A total of 180 full-term infants were included, 60 in each group. Infants in group I and II showed significant reduction of bilirubin levels at 36, 48, and 72 h from intervention compared to group III, respectively. Fenofibrate administration was associated with significantly shorter duration of phototherapy, shorter hospital stay, and higher frequency of exclusive breast-feeding compared to phototherapy alone.
CONCLUSION(S)


Fenofibrate as an adjuvant to phototherapy in term neonate with pathological jaundice is well tolerated and associated with significant reduction of serum bilirubin levels, a shorter duration of phototherapy, shorter hospital stay and higher frequency of exclusive breast-feeding, without significant adverse effects in either the single or double dosage.",2020,"I and II showed significant reduction of bilirubin levels at 36, 48, and 72 h from intervention compared to group III, respectively.","[""180 full-term infants with pathological unconjugated hyperbilirubinemia admitted to the NICU at Mansoura University Children's Hospital"", 'pathological jaundice in full-term infants', 'A total of 180 full-term infants were included, 60 in each group', 'pathological unconjugated hyperbilirubinemia in neonates']","['Fenofibrate', 'fenofibrate to phototherapy', 'placebo', 'oral fenofibrate']","['shorter duration of phototherapy, shorter hospital stay, and higher frequency of exclusive breast-feeding', 'total duration of treatment, need for exchange transfusions and intravenous immunoglobulin, exclusive breast-feeding on discharge, and adverse effects of fenofibrate', 'bilirubin levels', 'total serum bilirubin values', 'serum bilirubin levels']","[{'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C4551581', 'cui_str': 'Term baby'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0268306', 'cui_str': 'Unconjugated hyperbilirubinemia'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0022346', 'cui_str': 'Jaundice'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}]","[{'cui': 'C0033228', 'cui_str': 'Fenofibrate'}, {'cui': 'C0031765', 'cui_str': 'Light therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0439593', 'cui_str': 'Short duration'}, {'cui': 'C0031765', 'cui_str': 'Light therapy'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0242205', 'cui_str': 'Breastfeeding, Exclusive'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0444921', 'cui_str': 'Duration of treatment'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0015236', 'cui_str': 'Exchange transfusion'}, {'cui': 'C0085297', 'cui_str': 'Intravenous Immunoglobulins'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0033228', 'cui_str': 'Fenofibrate'}, {'cui': 'C0344395', 'cui_str': 'Bilirubin measurement'}, {'cui': 'C1278039', 'cui_str': 'Serum total bilirubin measurement'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0428441', 'cui_str': 'Serum bilirubin measurement'}]",180.0,0.341387,"I and II showed significant reduction of bilirubin levels at 36, 48, and 72 h from intervention compared to group III, respectively.","[{'ForeName': 'Mohammad Hosny', 'Initials': 'MH', 'LastName': 'Awad', 'Affiliation': ""Department of pediatrics, Mansoura University Children's Hospital, Mansoura, Egypt. mo7amed_hosny@hotmail.com.""}, {'ForeName': 'Sahar', 'Initials': 'S', 'LastName': 'Amer', 'Affiliation': 'Department of pediatrics, Insurance Hospital, Ministry of health, Mansoura, Egypt.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Hafez', 'Affiliation': ""Department of pediatrics, Mansoura University Children's Hospital, Mansoura, Egypt.""}, {'ForeName': 'Islam', 'Initials': 'I', 'LastName': 'Nour', 'Affiliation': ""Department of pediatrics, Mansoura University Children's Hospital, Mansoura, Egypt.""}, {'ForeName': 'AbdElaziz', 'Initials': 'A', 'LastName': 'Shabaan', 'Affiliation': ""Department of pediatrics, Mansoura University Children's Hospital, Mansoura, Egypt.""}]",Journal of perinatology : official journal of the California Perinatal Association,['10.1038/s41372-020-00861-2']
1473,33070154,"The effects of inhibition of fatty acid amide hydrolase (FAAH) by JNJ-42165279 in social anxiety disorder: a double-blind, randomized, placebo-controlled proof-of-concept study.","JNJ-42165279 is a selective inhibitor of fatty acid amide hydrolase (FAAH), the enzyme responsible for the degradation of fatty acid amides (FAA) including anandamide (AEA), palmitoylethanolamide (PEA), and N-oleoylethanolamide (OEA). We assessed the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of treatment with JNJ-42165279 in subjects with social anxiety disorder (SAD). This was a multicenter, double-blind, placebo-controlled study randomizing subjects to 12 weeks of treatment with either JNJ-42165279 (25 mg daily) or placebo (PBO). The primary endpoint was the change in the Liebowitz Social Anxiety Scale (LSAS) total score from baseline to end of study. Secondary endpoints included the Hamilton Anxiety Scale (HAM-A), Hamilton Depression Rating Scale (HDRS 17 ), and the Clinical Global Impression-Improvement (CGI-I). Samples were collected for plasma concentration of AEA, PEA, OEA, and JNJ-42165279. A total of 149 subjects were enrolled with a mean baseline LSAS total score of 102.6 (SD 16.84). The mean change from baseline (SD) in LSAS total score at week 12 was numerically greater for JNJ-42165279: -29.4 (27.47) compared to PBO: -22.4 (23.57) but not significant. The percentage of subjects with ≥30% improvement from baseline in the LSAS total score was significantly higher for JNJ-42165279 (42.4%) compared to PBO (23.6%) (p value = 0.04). The percentage of subjects with a CGI-I score of much or very much improved was also significantly higher for JNJ-42165279 (44.1%) than for PBO (23.6%) (p value = 0.02). The drug was well tolerated. JNJ-42165279 appears to elicit an anxiolytic effect in subjects with SAD although trough concentrations with 25 mg once daily appeared to be insufficient to completely inhibit FAAH activity which may have led to suboptimal efficacy. ClinicalTrials.gov Identifier: NCT02432703.",2020,The percentage of subjects with ≥30% improvement from baseline in the LSAS total score was significantly higher for JNJ-42165279 (42.4%) compared to PBO (23.6%) (p value = 0.04).,"['A total of 149 subjects were enrolled with a mean baseline LSAS total score of 102.6 (SD 16.84', 'social anxiety disorder', 'subjects with social anxiety disorder (SAD', 'subjects with SAD']","['placebo', 'JNJ-42165279', 'fatty acid amide hydrolase (FAAH', 'placebo (PBO']","['Liebowitz Social Anxiety Scale (LSAS) total score', 'anxiolytic effect', 'efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics', 'tolerated', 'plasma concentration of AEA, PEA, OEA, and JNJ-42165279', 'LSAS total score', 'Hamilton Anxiety Scale (HAM-A), Hamilton Depression Rating Scale (HDRS 17 ), and the Clinical Global Impression-Improvement (CGI-I', 'mean change from baseline (SD) in LSAS total score']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C5191071', 'cui_str': '149'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031572', 'cui_str': 'Social phobia'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C5139852', 'cui_str': 'JNJ-42165279'}, {'cui': 'C0531004', 'cui_str': 'fatty acid amide hydrolase'}]","[{'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3179404', 'cui_str': 'Anti-Anxiety Effects'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0002482', 'cui_str': 'Amide'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0211726', 'cui_str': 'anandamide'}, {'cui': 'C0069964', 'cui_str': 'palmidrol'}, {'cui': 'C1454896', 'cui_str': 'oleoylethanolamide'}, {'cui': 'C5139852', 'cui_str': 'JNJ-42165279'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C1840333', 'cui_str': 'Hypoparathyroidism, deafness, renal disease syndrome'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",149.0,0.0684413,The percentage of subjects with ≥30% improvement from baseline in the LSAS total score was significantly higher for JNJ-42165279 (42.4%) compared to PBO (23.6%) (p value = 0.04).,"[{'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Schmidt', 'Affiliation': 'Janssen Research & Development, Beerse, Belgium. mschmid4@its.jnj.com.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Liebowitz', 'Affiliation': 'The Medical Research Network, New York, NY, USA.'}, {'ForeName': 'Murray B', 'Initials': 'MB', 'LastName': 'Stein', 'Affiliation': 'University of California San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Grunfeld', 'Affiliation': 'Peninsula Therapeutic & Research Group, Frankston, VIC, Australia.'}, {'ForeName': 'Ilse', 'Initials': 'I', 'LastName': 'Van Hove', 'Affiliation': 'Janssen Research & Development, Beerse, Belgium.'}, {'ForeName': 'W Kyle', 'Initials': 'WK', 'LastName': 'Simmons', 'Affiliation': 'Janssen Research & Development, La Jolla, CA, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Van Der Ark', 'Affiliation': 'Janssen Research & Development, Beerse, Belgium.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Palmer', 'Affiliation': 'Janssen Research & Development, La Jolla, CA, USA.'}, {'ForeName': 'Ziad S', 'Initials': 'ZS', 'LastName': 'Saad', 'Affiliation': 'Janssen Research & Development, La Jolla, CA, USA.'}, {'ForeName': 'Darrel J', 'Initials': 'DJ', 'LastName': 'Pemberton', 'Affiliation': 'Janssen Research & Development, Beerse, Belgium.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Van Nueten', 'Affiliation': 'Janssen Research & Development, Beerse, Belgium.'}, {'ForeName': 'Wayne C', 'Initials': 'WC', 'LastName': 'Drevets', 'Affiliation': 'Janssen Research & Development, La Jolla, CA, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-00888-1']
1474,33076387,Effects of Yangsaeng (Health Management) Therapy for Korean Older Adults in Nursing Home.,"The number of older adults admitted to nursing homes is steadily increasing, and the health management for them is a very important issue in Korean society. This study aimed to examine the effects of Yangsaeng (health management) therapy on physical health status, depression, life satisfaction, and Yangsaeng (health management) of Korean older adults in nursing homes. A quasi-experimental study design using a pretest-posttest control group was employed. Study participants were a total of 80 older adults (intervention: n = 40, control: n = 40) in a nursing home in Seoul, South Korea. Yangsaeng therapy as an intervention consisted of the Meridian therapy and Qi-gong therapy. Yangsaeng therapy was conducted for 50 min per one time, twice a week, and for 10 weeks. Measures were general characteristics of study participants, Cornell Medical Index, Geriatric Depression Scale, life satisfaction scale, and Yangsaeng scale. Data were collected from April 2018 to March 2019. There were statistically significant differences on physical health status, depression, life satisfaction, and Yangsaeng between the two groups. Yangsaeng therapy was an effective intervention for improving physical health status, life satisfaction, and Yangsaeng, and for decreasing depression of older adults in nursing homes. Health care providers need to pay attention to Yangsaeng therapy as a Korean traditional intervention method for the health management of the older adults residing in nursing homes.",2020,"There were statistically significant differences on physical health status, depression, life satisfaction, and Yangsaeng between the two groups.","['Study participants were a total of 80 older adults (intervention: n = 40, control: n = 40) in a nursing home in Seoul, South Korea', 'older adults in nursing homes', 'Korean older adults in nursing homes', 'Korean Older Adults in Nursing Home', 'older adults residing in nursing homes', 'older adults admitted to nursing homes']","['Yangsaeng (health management) therapy', 'Yangsaeng (Health Management) Therapy', 'Yangsaeng therapy', 'Meridian therapy and Qi-gong therapy']","['Cornell Medical Index, Geriatric Depression Scale, life satisfaction scale, and Yangsaeng scale', 'physical health status, depression, life satisfaction, and Yangsaeng (health management', 'physical health status, life satisfaction, and Yangsaeng', 'physical health status, depression, life satisfaction, and Yangsaeng']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C3850150', 'cui_str': 'Seoul'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C1658399', 'cui_str': 'Admission to nursing home'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0085282', 'cui_str': 'Jingluo'}, {'cui': 'C0282077', 'cui_str': 'Qigong'}]","[{'cui': 'C0010045', 'cui_str': 'Cornell Medical Index'}, {'cui': 'C0451184', 'cui_str': 'Geriatric depression scale'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]",80.0,0.0188631,"There were statistically significant differences on physical health status, depression, life satisfaction, and Yangsaeng between the two groups.","[{'ForeName': 'Sohyune R', 'Initials': 'SR', 'LastName': 'Sok', 'Affiliation': 'College of Nursing Science, Kyung Hee University, Seoul 02447, Korea.'}, {'ForeName': 'Se Yun', 'Initials': 'SY', 'LastName': 'Kim', 'Affiliation': 'Department of Nursing, Graduate School, Kyung Hee University, Seoul 02447, Korea.'}, {'ForeName': 'Da Un', 'Initials': 'DU', 'LastName': 'Jung', 'Affiliation': 'Department of Nursing, Graduate School, Kyung Hee University, Seoul 02447, Korea.'}, {'ForeName': 'Youngmi', 'Initials': 'Y', 'LastName': 'Cho', 'Affiliation': 'Department of Nursing, Choonhae College of Health Sciences, Ulsan 44610, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17207507']
1475,33076411,Winter Exercise and Speleotherapy for Allergy and Asthma: A Randomized Controlled Clinical Trial.,"(1) Background: The prevalence of allergic respiratory diseases is still rising and efforts towards holistic treatments should be made. Although speleotherapy is widely applied in Europe to treat chronic airway diseases, the existing scientific evidence is rather low. Recreational winter exercise has been shown to improve allergic airway inflammation, but little is known about the combined effects of speleotherapy and recreational winter exercise. (2) Methods: In this clinical study we investigated the effects of winter exercise and speleotherapy on adults with allergic rhinitis and/or asthma. The speleotherapy group (n = 23) participated in a ten-day combined winter exercise and speleotherapy program and the exercise group (n = 18) joined a full-day winter sports program. The effects on allergic airway inflammation, quality of life, spirometry and cardiorespiratory fitness were assessed. (3) Results: No significant effects were found for fractional exhaled nitric oxide or nasal nitric oxide. Quality of life ( p  < 0.001 time effect) and allergic symptoms ( p  < 0.001 time effect) were improved in the speleotherapy and in the exercise group. (4) Conclusions: Winter exercise alone and winter exercise in combination with speleotherapy improve quality of life and allergic symptoms in adults with allergic rhinitis and/or asthma. Further studies are required to investigate the specific effects of speleotherapy. To our knowledge, this is the first investigation examining speleotherapy in combination with winter exercise. Recreational outdoor winter exercise and speleotherapy may be recommended for highly functioning patients with good disease control.",2020,Quality of life ( p  < 0.001 time effect) and allergic symptoms ( p  < 0.001 time effect) were improved in the speleotherapy and in the exercise group.,"['adults with allergic rhinitis and/or asthma', 'group (n = 23) participated in a ten', 'highly functioning patients with good disease control', 'Allergy and Asthma']","['Winter exercise alone and winter exercise in combination with speleotherapy', 'Winter Exercise and Speleotherapy', 'winter exercise and speleotherapy', 'Recreational outdoor winter exercise and speleotherapy', 'Recreational winter exercise', 'day combined winter exercise and speleotherapy program and the exercise group (n = 18) joined a full-day winter sports program', 'speleotherapy']","['fractional exhaled nitric oxide or nasal nitric oxide', 'allergic symptoms', 'Quality of life', 'allergic airway inflammation, quality of life, spirometry and cardiorespiratory fitness', 'quality of life and allergic symptoms']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0339510', 'cui_str': 'Vitelliform dystrophy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002111', 'cui_str': 'Allergy - specialty'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C2350293', 'cui_str': 'Speleotherapy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0038039', 'cui_str': 'Sport'}]","[{'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}]",23.0,0.0253318,Quality of life ( p  < 0.001 time effect) and allergic symptoms ( p  < 0.001 time effect) were improved in the speleotherapy and in the exercise group.,"[{'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Freidl', 'Affiliation': 'Institute of Ecomedicine, Paracelsus Medical University Salzburg, 5020 Salzburg, Austria.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Huber', 'Affiliation': 'Institute of Ecomedicine, Paracelsus Medical University Salzburg, 5020 Salzburg, Austria.'}, {'ForeName': 'Herbert', 'Initials': 'H', 'LastName': 'Braunschmid', 'Affiliation': 'Institute of Ecomedicine, Paracelsus Medical University Salzburg, 5020 Salzburg, Austria.'}, {'ForeName': 'Carina', 'Initials': 'C', 'LastName': 'Romodow', 'Affiliation': 'Institute of Ecomedicine, Paracelsus Medical University Salzburg, 5020 Salzburg, Austria.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Pichler', 'Affiliation': 'Institute of Ecomedicine, Paracelsus Medical University Salzburg, 5020 Salzburg, Austria.'}, {'ForeName': 'Renate', 'Initials': 'R', 'LastName': 'Weisböck-Erdheim', 'Affiliation': 'Institute of Ecomedicine, Paracelsus Medical University Salzburg, 5020 Salzburg, Austria.'}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Mayr', 'Affiliation': 'Institute of Ecomedicine, Paracelsus Medical University Salzburg, 5020 Salzburg, Austria.'}, {'ForeName': 'Arnulf', 'Initials': 'A', 'LastName': 'Hartl', 'Affiliation': 'Institute of Ecomedicine, Paracelsus Medical University Salzburg, 5020 Salzburg, Austria.'}]",Journal of clinical medicine,['10.3390/jcm9103311']
1476,33076693,Linked Color Imaging Focused on Neoplasm Detection in the Upper Gastrointestinal Tract : A Randomized Trial.,"BACKGROUND


Linked color imaging (LCI) is a new image-enhanced endoscopy technique that allows users to recognize slight differences in mucosal color.
OBJECTIVE


To compare the performance of LCI with white light imaging (WLI) in detecting neoplastic lesions in the upper gastrointestinal tract.
DESIGN


A controlled, multicenter trial with randomization using minimization. (University Hospital Medical Information Network Clinical Trials Registry: UMIN000023863).
SETTING


16 university hospitals and 3 tertiary care hospitals in Japan.
PATIENTS


1502 patients with known previous or current cancer of the gastrointestinal tract and undergoing surveillance for gastrointestinal cancer.
INTERVENTION


WLI followed by LCI examination (WLI group) or LCI followed by WLI examination (LCI group).
MEASUREMENTS


Diagnosis of 1 or more neoplastic lesions in the pharynx, esophagus, or stomach in the first examination (primary outcome) and 1 or more neoplastic lesions overlooked in the first examination (secondary outcome).
RESULTS


752 patients were assigned to the WLI group and 750 to the LCI group. The percentage of patients with 1 or more neoplastic lesions diagnosed in the first examination was higher with LCI than with WLI (60 of 750 patients or 8.0% [95% CI, 6.2% to 10.2%] vs. 36 of 752 patients or 4.8% [CI, 3.4% to 6.6%]; risk ratio, 1.67 [CI, 1.12 to 2.50;  P  = 0.011]). The proportion with overlooked neoplasms was lower in the LCI group than in the WLI group (5 of 750 patients or 0.67% [CI, 0.2% to 1.6%] vs. 26 of 752 patients or 3.5% [CI, 2.3% to 5.0%]; risk ratio, 0.19 [CI, 0.07 to 0.50]).
LIMITATION


Endoscopists were not blinded.
CONCLUSION


LCI is more effective than WLI for detecting neoplastic lesions in the pharynx, esophagus, and stomach.
PRIMARY FUNDING SOURCE


Fujifilm Corporation.",2020,"The proportion with overlooked neoplasms was lower in the LCI group than in the WLI group (5 of 750 patients or 0.67% [CI, 0.2% to 1.6%] vs. 26 of 752 patients or 3.5% [CI, 2.3% to 5.0%]; risk ratio, 0.19 [CI, 0.07 to 0.50]).
","['16 university hospitals and 3 tertiary care hospitals in Japan', 'Upper Gastrointestinal Tract ', '752 patients were assigned to the WLI group and 750 to the LCI group', '1502 patients with known previous or current cancer of the gastrointestinal tract and undergoing surveillance for gastrointestinal cancer']","['LCI with white light imaging (WLI', 'Linked color imaging (LCI', 'WLI followed by LCI examination (WLI group) or LCI followed by WLI examination (LCI group', 'LCI']","['proportion with overlooked neoplasms', 'Diagnosis of 1 or more neoplastic lesions in the pharynx, esophagus, or stomach']","[{'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C3203348', 'cui_str': 'Upper gastrointestinal tract structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0563228', 'cui_str': 'White light'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517868', 'cui_str': '750'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0685938', 'cui_str': 'Malignant neoplasm of gastrointestinal tract'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}]","[{'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0563228', 'cui_str': 'White light'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0031354', 'cui_str': 'Pharyngeal structure'}, {'cui': 'C0014876', 'cui_str': 'Esophageal structure'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}]",1502.0,0.112427,"The proportion with overlooked neoplasms was lower in the LCI group than in the WLI group (5 of 750 patients or 0.67% [CI, 0.2% to 1.6%] vs. 26 of 752 patients or 3.5% [CI, 2.3% to 5.0%]; risk ratio, 0.19 [CI, 0.07 to 0.50]).
","[{'ForeName': 'Shoko', 'Initials': 'S', 'LastName': 'Ono', 'Affiliation': 'Hokkaido University Hospital, Sapporo, Japan (S.O., M.T.).'}, {'ForeName': 'Kenro', 'Initials': 'K', 'LastName': 'Kawada', 'Affiliation': 'Tokyo Medical and Dental University, Tokyo, Japan (K.K.).'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Dohi', 'Affiliation': 'Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan (O.D., Y.N.).'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Kitamura', 'Affiliation': 'Tokushima University Graduate School of Biomedical Sciences, Tokushima, Japan (S.K.).'}, {'ForeName': 'Tomoyuki', 'Initials': 'T', 'LastName': 'Koike', 'Affiliation': 'Tohoku University Graduate School of Medicine, Sendai, Japan (T.K.).'}, {'ForeName': 'Shinichiro', 'Initials': 'S', 'LastName': 'Hori', 'Affiliation': 'National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan (S.H.).'}, {'ForeName': 'Hiromitsu', 'Initials': 'H', 'LastName': 'Kanzaki', 'Affiliation': 'Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Japan (H.K.).'}, {'ForeName': 'Takahisa', 'Initials': 'T', 'LastName': 'Murao', 'Affiliation': 'Kawasaki Medical School, Okayama, Japan (T.M.).'}, {'ForeName': 'Nobuaki', 'Initials': 'N', 'LastName': 'Yagi', 'Affiliation': 'Asahi University Hospital, Gifu, Japan (N.Y.).'}, {'ForeName': 'Fumisato', 'Initials': 'F', 'LastName': 'Sasaki', 'Affiliation': 'Kagoshima University Graduate School of Medical and Dental Sciences, Kagoshima, Japan (F.S.).'}, {'ForeName': 'Keiichi', 'Initials': 'K', 'LastName': 'Hashiguchi', 'Affiliation': 'Nagasaki University Hospital, Nagasaki, Japan (K.H., K.H.).'}, {'ForeName': 'Shiro', 'Initials': 'S', 'LastName': 'Oka', 'Affiliation': 'Hiroshima University Hospital, Hiroshima, Japan (S.O.).'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Katada', 'Affiliation': 'North Medical Center, Kyoto Prefectural University of Medicine, Kyoto, Japan (K.K.).'}, {'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Shimoda', 'Affiliation': 'Saga University, Saga, Japan (R.S.).'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Mizukami', 'Affiliation': 'Oita University, Oita, Japan (K.M., K.M.).'}, {'ForeName': 'Mitsuhiko', 'Initials': 'M', 'LastName': 'Suehiro', 'Affiliation': 'Kawasaki Medical School General Medical Center, Okayama, Japan (M.S.).'}, {'ForeName': 'Toshihisa', 'Initials': 'T', 'LastName': 'Takeuchi', 'Affiliation': 'Osaka Medical College, Osaka, Japan (T.T.).'}, {'ForeName': 'Shinichi', 'Initials': 'S', 'LastName': 'Katsuki', 'Affiliation': 'Otaru Ekisaikai Hospital, Otaru, Japan (S.K.).'}, {'ForeName': 'Momoko', 'Initials': 'M', 'LastName': 'Tsuda', 'Affiliation': 'Hokkaido University Hospital, Sapporo, Japan (S.O., M.T.).'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Naito', 'Affiliation': 'Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan (O.D., Y.N.).'}, {'ForeName': 'Tatsuyuki', 'Initials': 'T', 'LastName': 'Kawano', 'Affiliation': 'Soka Municipal Hospital, Soka, Japan (T.K.).'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Haruma', 'Affiliation': 'Nagasaki University Hospital, Nagasaki, Japan (K.H., K.H.).'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Ishikawa', 'Affiliation': 'Kyoto Prefectural University of Medicine, Osaka, Japan (H.I.).'}, {'ForeName': 'Keita', 'Initials': 'K', 'LastName': 'Mori', 'Affiliation': 'Oita University, Oita, Japan (K.M., K.M.).'}, {'ForeName': 'Mototsugu', 'Initials': 'M', 'LastName': 'Kato Md', 'Affiliation': 'National Hospital Organization Hakodate National Hospital, Hakodate,Japan (M.K.).'}]",Annals of internal medicine,['10.7326/M19-2561']
1477,33076707,"""Short- and mid-term effects of adding upper cervical manual therapy to a conventional physical therapy program in patients with chronic mechanical neck pain. Randomized controlled clinical trial.""","OBJECTIVE


To evaluate the effect of adding an Upper Cervical Translatoric Mobilization (UCTM) or an Inhibitory Suboccipital Technique (IST) to a physiotherapy treatment in the symptomatology and function of mechanical chronic neck pain patients.
DESIGN


Randomized controlled trial.
SETTING


Primary Care Center in Cornellà, Spain.
SUBJECTS


78 patients (64 women), with mean age (SD) of 59.96 (13.30) years with mechanical chronic neck pain were divided in three groups: control, IST and UCTM groups.
INTERVENTIONS


All groups received 15 physiotherapy sessions for three weeks. The UCTM and IST groups added 5 minutes of the assigned technique during six sessions.
MAIN MEASURES


Neck disability index (NDI) and numeric pain rating scale (NPRS) for neck pain were measured baseline, three-weeks and 15-weeks follow-up.
RESULTS


NDI (SD) at baseline, three-weeks and 15-weeks were 11.62 (7.08), 9.65 (6.25), 7.58 (5.64) for the control group, 14.38 (6.92), 8.50 (6.11), 7.12 (4.98) for the IST group and 13.19(7.23), 5.35(6.10), 4.35(2.76) for the UCTM group. NPRS (SD) at baseline, three-weeks and 15-weeks were 58.69 (19.46), 45.19 (23.43), 44.58 (24.08) for the control group; 64.08 (19.26), 42.19 (19.69), 34 (21.14) for the IST group; and 67.65 (20.65), 36.23 (20.10), 39.85 (25.44) for the UCTM group.
CONCLUSIONS


Compared with no treatment, both forms of mobilization were associated with reduced disability at three weeks, and UCTM remained better than control at 15 weeks; there were no significant differences between the two mobilization groups.
TRIAL REGISTRATION


This study was registered in Clinicaltrials.gov (NCT02832232).",2020,"Compared with no treatment, both forms of mobilization were associated with reduced disability at three weeks, and UCTM remained better than control at 15 weeks; there were no significant differences between the two mobilization groups.
","['78 patients (64 women), with mean age (SD) of 59.96 (13.30) years with mechanical chronic neck pain', 'Primary Care Center in Cornellà, Spain', 'patients with chronic mechanical neck pain', 'mechanical chronic neck pain patients']","['physiotherapy treatment', 'Upper Cervical Translatoric Mobilization (UCTM', 'control, IST and UCTM groups', 'Inhibitory Suboccipital Technique (IST', 'upper cervical manual therapy', 'conventional physical therapy program']","['Neck disability index (NDI) and numeric pain rating scale (NPRS) for neck pain', 'NPRS (SD', 'reduced disability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0746815', 'cui_str': 'Chronic neck pain'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}]","[{'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0442187', 'cui_str': 'Suboccipital approach'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0454525', 'cui_str': 'Manual therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}]",78.0,0.19135,"Compared with no treatment, both forms of mobilization were associated with reduced disability at three weeks, and UCTM remained better than control at 15 weeks; there were no significant differences between the two mobilization groups.
","[{'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'González-Rueda', 'Affiliation': 'Facultat de Medicina i Ciències de la Salut, Universitat Intenacional de Catalunya, Barcelona, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'López-de-Celis', 'Affiliation': 'Facultat de Medicina i Ciències de la Salut, Universitat Intenacional de Catalunya, Barcelona, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Bueno-Gracia', 'Affiliation': 'Unidad de Investigación en Fisioterapia, Facultad de Ciencias de la Salud, Universidad de Zaragoza, Zaragoza, Spain.'}, {'ForeName': 'Jacobo', 'Initials': 'J', 'LastName': 'Rodríguez-Sanz', 'Affiliation': 'Facultat de Medicina i Ciències de la Salut, Universitat Intenacional de Catalunya, Barcelona, Spain.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Pérez-Bellmunt', 'Affiliation': 'Facultat de Medicina i Ciències de la Salut, Universitat Intenacional de Catalunya, Barcelona, Spain.'}, {'ForeName': 'Martín Eusebio', 'Initials': 'ME', 'LastName': 'Barra-López', 'Affiliation': 'Facultat de Medicina i Ciències de la Salut, Universitat Intenacional de Catalunya, Barcelona, Spain.'}, {'ForeName': 'César', 'Initials': 'C', 'LastName': 'Hidalgo García', 'Affiliation': 'Unidad de Investigación en Fisioterapia, Facultad de Ciencias de la Salud, Universidad de Zaragoza, Zaragoza, Spain.'}]",Clinical rehabilitation,['10.1177/0269215520965054']
1478,33076764,The Effects of Heat Exposure During Intermittent Exercise on Physical and Cognitive Performance Among Team Sport Athletes.,"This study investigated the effects of heat exposure on physical and cognitive performance during an intermittent exercise protocol so as to reflect the incremental fatigue experienced during team sports. Twelve well-trained male team sport players completed an 80-minute cycling intermittent sprint protocol (CISP), alongside computerized vigilance and congruent (i.e., simple) and incongruent (i.e., complex) Stroop tasks of cognitive functioning, in two counterbalanced temperature conditions; hot (32°C[50%rh]) and control (18°C[50%rh]). Incongruent Stroop accuracy declined over time ( p  = .002), specifically in the second ( M diff  =  -3.75,  SD  = 0.90%,  p  = .009) and third ( M diff   = -4.58,  SD  = 1.22%,  p  = .019) quarters compared to the first quarter of the CISP; but there were no differences between temperature conditions. Congruent Stroop reaction time (RT) was quicker in the second quarter of exercise in the hot condition ( M  = 561.99,  SD  = 112.93 ms) compared to the control condition ( M =617.80,  SD  = 139.71 ms;  p  = .022), but no differences were found for congruent Stroop accuracy nor vigilance measures. Additionally, peak power output was lower during the third quarter of the CISP in the hot condition ( M  = 861.31,  SD  = 105.20 W) compared to the control condition ( M  = 900.68,  SD  = 114.84 W;  p  < .001). Plasma normetanephrine and metanephrine concentrations increased from pre- to post-CISP ( M diff  =  +616.90,  SD  = 306.99,  p  < .001; and  M diff   = +151.23,  SD  = 130.32,  p  = .002, respectively), with a marginal interaction suggesting a higher normetanephrine increase from pre- to post-CISP in the hot versus the control condition ( p  = .070). Our findings suggest that accuracy for more complex decisions suffered during prolonged high-intensity intermittent exercise, perhaps due to exercise-induced catecholamine increases. Athletes may have also reduced physical effort under increased heat exposure, indicating how cognitive performance may be sustained in physically demanding environments.",2020,"Incongruent Stroop accuracy declined over time ( p  = .002), specifically in the second ( M diff  =  -3.75,  SD  = 0.90%,  p  = .009) and third ( M diff   = -4.58,  SD  = 1.22%,  p  = .019) quarters compared to the first quarter of the CISP; but there were no differences between temperature conditions.","['Team Sport Athletes', 'Twelve well-trained male team sport players completed an']","['80-minute cycling intermittent sprint protocol (CISP), alongside computerized vigilance and congruent (i.e., simple) and incongruent (i.e., complex) Stroop tasks of cognitive functioning, in two counterbalanced temperature conditions; hot (32°C[50%rh]) and control (18°C[50%rh', 'heat exposure', 'Heat Exposure During Intermittent Exercise']","['Plasma normetanephrine and metanephrine concentrations', 'Physical and Cognitive Performance', 'Congruent Stroop reaction time (RT', 'Incongruent Stroop accuracy', 'peak power output', 'physical and cognitive performance']","[{'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0043012', 'cui_str': 'Wakefulness'}, {'cui': 'C0439853', 'cui_str': 'Congruent'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C1321310', 'cui_str': 'Incongruous'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C2718024', 'cui_str': 'Stroop Task'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0444519', 'cui_str': 'Hot'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0239930', 'cui_str': 'Heat exposure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0028385', 'cui_str': 'Normetanephrine'}, {'cui': 'C0025562', 'cui_str': 'Metanephrine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0439853', 'cui_str': 'Congruent'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C1321310', 'cui_str': 'Incongruous'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0445194', 'cui_str': 'Power output'}]",,0.040461,"Incongruent Stroop accuracy declined over time ( p  = .002), specifically in the second ( M diff  =  -3.75,  SD  = 0.90%,  p  = .009) and third ( M diff   = -4.58,  SD  = 1.22%,  p  = .019) quarters compared to the first quarter of the CISP; but there were no differences between temperature conditions.","[{'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Donnan', 'Affiliation': 'Carnegie School of Sport, Leeds Beckett University, Leeds, United Kingdom.'}, {'ForeName': 'Emily L', 'Initials': 'EL', 'LastName': 'Williams', 'Affiliation': 'Carnegie School of Sport, Leeds Beckett University, Leeds, United Kingdom.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Stanger', 'Affiliation': 'Carnegie School of Sport, Leeds Beckett University, Leeds, United Kingdom.'}]",Perceptual and motor skills,['10.1177/0031512520966522']
1479,33076805,Evaluation of plasma free amino acid and carnitine levels in patients with cesarean scar pregnancy.,"AIM AND OBJECTIVE


This study aimed to explore the plasma free amino acid (FAA) and carnitine levels in pregnant women with cesarean scar pregnancy (CSP), and to compare them with those of healthy pregnant women.
MATERIALS AND METHODS


This prospective and randomized controlled study was conducted in patients admitted to Harran University Medical Faculty Hospital Obstetrics Clinic between January 2018 and January 2019. A total of 60 patients were included in the study, and the patients were divided into two groups: CSP group (n = 30) and healthy pregnant group as the control group (n = 30). The blood samples were taken from the participants between 7 - 12 weeks of gestation. Twentyseven carnitines and their esters and 14 FAAs were analysed by liquid chromatography - mass spectrometry (LC-MS/MS).
RESULTS


The mean plasma concentrations of some carnitines, including C2, C5, C5-OH, C5-DC, C6, C8-1, C12, C14, C14- 1, C14-2, C16, C16-1, C18, and C18-1 were significantly higher in CSP group than in the control group. However, other carnitines, including C0, C3, C4, C4-DC, C5-1, C6-DC, C8, C8-DC, C10, C10-1, C18-1-OH, and C18-2 were similar in both groups. The plasma levels of some FAAs, including Methyl Glutaryl, Leu, Met, Phe, Arg, Orn, and Glu values were significantly higher in CSP group than in the control group. However, there was no statistically significance in other FAA levels, including Val, Asa, Tyr, Asp, Ala, Cit, and Gly between the two groups. Additionally, Pearson's correlation analysis showed that there were significantly positive correlations between many FAA and carnitine values.
CONCLUSION


Since several plasma carnitine and FAA levels were higher in CSP group than in the control group, we think that scar pregnancy increases metabolic need for myometrial invasion. Also, we think that these results may be useful in clinical practice for CSP diagnosis.",2020,"However, there was no statistically significance in other FAA levels, including Val, Asa, Tyr, Asp, Ala, Cit, and Gly between the two groups.","['A total of 60 patients', 'patients with cesarean scar pregnancy', 'patients admitted to Harran University Medical Faculty Hospital Obstetrics Clinic between January 2018 and January 2019', 'healthy pregnant women', 'pregnant women with cesarean scar pregnancy (CSP']",['CSP'],"['plasma free amino acid (FAA) and carnitine levels', 'FAA levels, including Val, Asa, Tyr, Asp, Ala, Cit, and Gly', 'mean plasma concentrations of some carnitines, including C2, C5, C5-OH, C5-DC, C6, C8-1, C12, C14, C14- 1, C14-2, C16, C16-1, C18, and C18-1', 'plasma carnitine and FAA levels', 'plasma levels of some FAAs, including Methyl Glutaryl, Leu, Met, Phe, Arg, Orn, and Glu values', 'C0, C3, C4, C4-DC, C5-1, C6-DC, C8, C8-DC, C10, C10-1, C18-1-OH, and C18-2', 'blood samples']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0015537', 'cui_str': 'Faculties, Medical'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}]","[{'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0002520', 'cui_str': 'amino acids'}, {'cui': 'C0007258', 'cui_str': 'Carnitine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1328436', 'cui_str': 'Amino acid level'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0042285', 'cui_str': 'Valine'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0041484', 'cui_str': 'Monophenol monooxygenase'}, {'cui': 'C0004015', 'cui_str': 'Aspartic Acid'}, {'cui': 'C0001898', 'cui_str': 'Alanine'}, {'cui': 'C0008864', 'cui_str': 'Citrulline'}, {'cui': 'C0017890', 'cui_str': 'Glycine'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0023401', 'cui_str': 'Leucine'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0031453', 'cui_str': 'Phenylalanine'}, {'cui': 'C0003761', 'cui_str': 'Argentina'}, {'cui': 'C0061055', 'cui_str': 'gamma-glutamyl-alpha-aminobutyrate'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0025250', 'cui_str': 'Lymphocyte antigen CD10'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}]",60.0,0.0270527,"However, there was no statistically significance in other FAA levels, including Val, Asa, Tyr, Asp, Ala, Cit, and Gly between the two groups.","[{'ForeName': 'Omer', 'Initials': 'O', 'LastName': 'Tammo', 'Affiliation': 'Department of Obstetrics and Gynecology, Harran University School of Medicine, Sanliurfa. Turkey.'}, {'ForeName': 'Hacer', 'Initials': 'H', 'LastName': 'Uyanikoglu', 'Affiliation': 'Department of Obstetrics and Gynecology, Harran University School of Medicine, Sanliurfa. Turkey.'}, {'ForeName': 'İsmail', 'Initials': 'İ', 'LastName': 'Koyuncu', 'Affiliation': 'Department of Biochemistry, Harran University School of Medicine, Sanliurfa. Turkey.'}]",Combinatorial chemistry & high throughput screening,['10.2174/1386207323666201019151530']
1480,33076866,Genotype-Informed Versus Empiric Management Of VirEmia (GIVE MOVE): study protocol of an open-label randomised clinical trial in children and adolescents living with HIV in Lesotho and Tanzania.,"BACKGROUND


Globally, the majority of people living with HIV have no or only limited access to HIV drug resistance testing to guide the selection of antiretroviral drugs. This is of particular concern for children and adolescents, who experience high rates of treatment failure. The GIVE MOVE trial assesses the clinical impact and cost-effectiveness of routinely providing genotypic resistance testing (GRT) to children and adolescents living with HIV who have an unsuppressed viral load (VL) while taking antiretroviral therapy (ART).
METHODS


GIVE MOVE is an open-label randomised clinical trial enrolling children and adolescents (≥6 months to <19 years) living with HIV with a VL ≥400 copies/mL (c/mL) while taking first-line ART. Recruitment takes place at sites in Lesotho and Tanzania. Participants are randomised in a 1:1 allocation to a control arm receiving the standard of care (3 sessions of enhanced adherence counselling, a follow-up VL test, continuation of the same regimen upon viral resuppression or empiric selection of a new regimen upon sustained elevated viremia) and an intervention arm (GRT to inform onward treatment). The composite primary endpoint is the occurrence of any one or more of the following events during the 36 weeks of follow-up period: i) death due to any cause; ii) HIV- or ART-related hospital admission of ≥24 h duration; iii) new clinical World Health Organisation stage 4 event (excluding lymph node tuberculosis, stunting, oral or genital herpes simplex infection and oesophageal candidiasis); and iv) no documented VL <50 c/mL at 36 weeks follow-up. Secondary and exploratory endpoints assess additional health-related outcomes, and a nested study will assess the cost-effectiveness of the intervention. Enrolment of a total of 276 participants is planned, with an interim analysis scheduled after the first 138 participants have completed follow-up.
DISCUSSION


This randomised clinical trial will assess if the availability of resistance testing improves clinical outcomes in children and adolescents with elevated viremia while taking ART.
TRIAL REGISTRATION


This trial is registered with ClinicalTrials.gov ( NCT04233242 ; registered 18.01.2020). More information: www.givemove.org .",2020,"This randomised clinical trial will assess if the availability of resistance testing improves clinical outcomes in children and adolescents with elevated viremia while taking ART.
","['children and adolescents living with HIV who have an unsuppressed viral load (VL) while taking antiretroviral therapy (ART', 'children and adolescents with elevated viremia while taking ART', 'children and adolescents, who experience high rates of treatment failure', 'children and adolescents (≥6\u2009months to <19\u2009years) living with HIV with a VL ≥400 copies/mL (c/mL) while taking first-line ART', '276 participants is planned, with an interim analysis scheduled after the first 138 participants have completed follow-up', 'children and adolescents living with HIV in Lesotho and Tanzania']","['control arm receiving the standard of care (3 sessions of enhanced adherence counselling', 'genotypic resistance testing (GRT']","['occurrence of any one or more of the following events during the 36\u2009weeks of follow-up period: i) death due to any cause; ii) HIV- or ART-related hospital admission of ≥24\u2009h duration; iii) new clinical World Health Organisation stage 4 event (excluding lymph node tuberculosis, stunting, oral or genital herpes simplex infection and oesophageal candidiasis); and iv) no documented VL']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0042749', 'cui_str': 'Viremia'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0023376', 'cui_str': 'Lesotho'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0392366', 'cui_str': 'Tests'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0043236', 'cui_str': 'Worldwide Health'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0041316', 'cui_str': 'Tuberculous adenitis'}, {'cui': 'C0018273', 'cui_str': 'Growth disorder'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0019342', 'cui_str': 'Genital herpes simplex'}, {'cui': 'C0228492', 'cui_str': 'Structure of posterior semilunar lobule'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0239295', 'cui_str': 'Candidiasis of the esophagus'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}]",276.0,0.292711,"This randomised clinical trial will assess if the availability of resistance testing improves clinical outcomes in children and adolescents with elevated viremia while taking ART.
","[{'ForeName': 'Jennifer Anne', 'Initials': 'JA', 'LastName': 'Brown', 'Affiliation': 'Swiss Tropical and Public Health Institute, Basel, Switzerland.'}, {'ForeName': 'Isaac', 'Initials': 'I', 'LastName': 'Ringera', 'Affiliation': 'SolidarMed, Partnerships for Health, Maseru, Lesotho.'}, {'ForeName': 'Ezekiel', 'Initials': 'E', 'LastName': 'Luoga', 'Affiliation': 'Ifakara Health Institute, Ifakara, Tanzania.'}, {'ForeName': 'Molisana', 'Initials': 'M', 'LastName': 'Cheleboi', 'Affiliation': 'Seboche Mission Hospital, Seboche, Lesotho.'}, {'ForeName': 'Namvua', 'Initials': 'N', 'LastName': 'Kimera', 'Affiliation': 'Ifakara Health Institute, Ifakara, Tanzania.'}, {'ForeName': 'Josephine', 'Initials': 'J', 'LastName': 'Muhairwe', 'Affiliation': 'SolidarMed, Partnerships for Health, Maseru, Lesotho.'}, {'ForeName': 'Buntshi Paulin', 'Initials': 'BP', 'LastName': 'Kayembe', 'Affiliation': ""Baylor College of Medicine Children's Foundation Lesotho, Maseru, Lesotho.""}, {'ForeName': 'Mosa', 'Initials': 'M', 'LastName': 'Molapo Hlasoa', 'Affiliation': ""Baylor College of Medicine Children's Foundation Lesotho, Maseru, Lesotho.""}, {'ForeName': 'Lorraine', 'Initials': 'L', 'LastName': 'Kabundi', 'Affiliation': ""Baylor College of Medicine Children's Foundation Lesotho, Maseru, Lesotho.""}, {'ForeName': 'Ching Wey David', 'Initials': 'CWD', 'LastName': 'Yav', 'Affiliation': ""Baylor College of Medicine Children's Foundation Lesotho, Maseru, Lesotho.""}, {'ForeName': 'Buoang', 'Initials': 'B', 'LastName': 'Mothobi', 'Affiliation': 'SolidarMed, Partnerships for Health, Maseru, Lesotho.'}, {'ForeName': 'Lineo', 'Initials': 'L', 'LastName': 'Thahane', 'Affiliation': ""Baylor College of Medicine Children's Foundation Lesotho, Maseru, Lesotho.""}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Amstutz', 'Affiliation': 'Swiss Tropical and Public Health Institute, Basel, Switzerland.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Bachmann', 'Affiliation': 'Swiss Tropical and Public Health Institute, Basel, Switzerland.'}, {'ForeName': 'Getrud Joseph', 'Initials': 'GJ', 'LastName': 'Mollel', 'Affiliation': 'Ifakara Health Institute, Ifakara, Tanzania.'}, {'ForeName': 'Moniek', 'Initials': 'M', 'LastName': 'Bresser', 'Affiliation': 'Swiss Tropical and Public Health Institute, Basel, Switzerland.'}, {'ForeName': 'Tracy Renée', 'Initials': 'TR', 'LastName': 'Glass', 'Affiliation': 'Swiss Tropical and Public Health Institute, Basel, Switzerland.'}, {'ForeName': 'Daniel Henry', 'Initials': 'DH', 'LastName': 'Paris', 'Affiliation': 'Swiss Tropical and Public Health Institute, Basel, Switzerland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Klimkait', 'Affiliation': 'Molecular Virology, Department of Biomedicine, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'Weisser', 'Affiliation': 'Swiss Tropical and Public Health Institute, Basel, Switzerland.'}, {'ForeName': 'Niklaus Daniel', 'Initials': 'ND', 'LastName': 'Labhardt', 'Affiliation': 'Swiss Tropical and Public Health Institute, Basel, Switzerland. n.labhardt@swisstph.ch.'}]",BMC infectious diseases,['10.1186/s12879-020-05491-9']
1481,33076878,"The effects of six months Persicaria minor extract supplement among older adults with mild cognitive impairment: a double-blinded, randomized, and placebo-controlled trial.","BACKGROUND


Persicaria minor extract exhibits antioxidant and anti-inflammatory properties and has potential effects on cognitive function and mood. However, the effects of P.minor on brain activation and biomarkers have not been studied among older adults. This multicentre, randomized, double-blinded, placebo-controlled study aimed to investigate the effect of 6 months P.minor extract supplement (Biokesum®) on cognition, mood, biomarkers, and brain activation among older adults with Mild Cognitive Impairment (MCI).
METHOD


A total of 36 Malaysian community-dwelling older adults with MCI (60-75-year-old) were randomized into Biokesum® (n = 18) and placebo group (n = 18). Each subject consumed one capsule of Biokesum® (250 mg/capsule) or placebo (maltodextrin, 280 mg/capsule) twice daily for 6 months. Cognitive function and mood were assessed at baseline, 3rd, and 6th-month using neuropsychological tests (MMSE, Digit Span, RAVLT, Digit Symbol, and Visual Reproduction) and Profile of Mood State (POMS) questionnaire. Blood lipid profile, fasting blood glucose, and biomarkers (MDA, LPO, COX-2, iNOS, and BDNF) were measured at baseline and 6th month. By the end of the intervention, there were 30 compliers (Biokesum®: N = 15; Placebo: N = 15) and 6 dropouts. For brain activation assessment, 15 subsamples (Biokesum®: N = 8; Placebo: N = 7) completed N-back and Stroop tasks during fMRI scanning at baseline and 6th month. The dorsolateral prefrontal cortex (Brodmann's area 9 and 46) was identified as a region of interest (ROI) for brain activation analysis using SPM software.
RESULTS


Two-way mixed ANOVA analysis showed significant improvements in Visual Reproduction II (p = 0.012, partial η 2  = 0.470), tension (p = 0.042, partial η 2  = 0.147), anger (p = 0.010, partial η 2  = 0.207), confusion (p = 0.041, partial η 2  = 0.148), total negative subscales (p = 0.043, partial η 2  = 0.145), BDNF (p = 0.020, partial η 2  = 0.179) and triglyceride (p = 0.029, partial η 2  = 0.237) following 6 months of Biokesum® supplementation. Preliminary finding also demonstrated significant improvement at 0-back task-induced right DLPFC activation (p = 0.028, partial η 2  = 0.652) among subsamples in Biokesum® group. No adverse events were reported at the end of the study.
CONCLUSION


Six months Biokesum® supplementation potentially improved visual memory, negative mood, BDNF, and triglyceride levels among older adults with MCI. Significant findings on brain activation at the right DPLFC must be considered as preliminary.
TRIAL REGISTRATION


Retrospectively registered on 30th August 2019 [ ISRC TN12417552 ].",2020,"Biokesum® supplementation potentially improved visual memory, negative mood, BDNF, and triglyceride levels among older adults with MCI.","['older adults', 'older adults with MCI', 'older adults with Mild Cognitive Impairment (MCI', 'Retrospectively registered on 30th August 2019', 'older adults with mild cognitive impairment', '36 Malaysian community-dwelling older adults with MCI (60-75-year-old']","['Biokesum®', '6\xa0months P.minor extract supplement (Biokesum®', 'six months Persicaria minor extract supplement', 'Biokesum® supplementation', 'Placebo: N\u2009=\u20097) completed N-back and Stroop tasks during fMRI scanning', 'placebo', 'placebo (maltodextrin', 'Placebo']","['cognition, mood, biomarkers, and brain activation', 'total negative subscales', '0-back task-induced right DLPFC activation', 'Visual Reproduction', 'BDNF', 'adverse events', 'visual memory, negative mood, BDNF, and triglyceride levels', 'brain activation', 'Cognitive function and mood', 'triglyceride', 'Blood lipid profile, fasting blood glucose, and biomarkers (MDA, LPO, COX-2, iNOS, and BDNF', 'neuropsychological tests (MMSE, Digit Span, RAVLT, Digit Symbol, and Visual Reproduction) and Profile of Mood State (POMS) questionnaire']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C2718024', 'cui_str': 'Stroop Task'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0542316', 'cui_str': 'Visual memory'}, {'cui': 'C0202236', 'cui_str': 'Triglycerides measurement'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0000379', 'cui_str': 'Methylenedioxyamphetamine'}, {'cui': 'C0023776', 'cui_str': 'Fatty Acid Hydroperoxides'}, {'cui': 'C1565860', 'cui_str': 'PTGS2 protein, human'}, {'cui': 'C0021528', 'cui_str': 'Inosine'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0451394', 'cui_str': 'Profile of mood states'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",36.0,0.430065,"Biokesum® supplementation potentially improved visual memory, negative mood, BDNF, and triglyceride levels among older adults with MCI.","[{'ForeName': 'Huijin', 'Initials': 'H', 'LastName': 'Lau', 'Affiliation': 'Center for Healthy Aging and Wellness, Faculty of Health Sciences, Universiti Kebangsaan Malaysia, Jalan Raja Muda Abdul Aziz, 50300, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Suzana', 'Initials': 'S', 'LastName': 'Shahar', 'Affiliation': 'Center for Healthy Aging and Wellness, Faculty of Health Sciences, Universiti Kebangsaan Malaysia, Jalan Raja Muda Abdul Aziz, 50300, Kuala Lumpur, Malaysia. suzana.shahar@ukm.edu.my.'}, {'ForeName': 'Mazlyfarina', 'Initials': 'M', 'LastName': 'Mohamad', 'Affiliation': 'Centre for Diagnostic and Applied Sciences, Faculty of Health Sciences, Universiti Kebangsaan Malaysia, Jalan Raja Muda Abdul Aziz, 50300, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Nor Fadilah', 'Initials': 'NF', 'LastName': 'Rajab', 'Affiliation': 'Center for Healthy Aging and Wellness, Faculty of Health Sciences, Universiti Kebangsaan Malaysia, Jalan Raja Muda Abdul Aziz, 50300, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Hanis Mastura', 'Initials': 'HM', 'LastName': 'Yahya', 'Affiliation': 'Center for Healthy Aging and Wellness, Faculty of Health Sciences, Universiti Kebangsaan Malaysia, Jalan Raja Muda Abdul Aziz, 50300, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Normah Che', 'Initials': 'NC', 'LastName': 'Din', 'Affiliation': 'Center for Rehabilitation Sciences, Faculty of Health Sciences, Universiti Kebangsaan Malaysia, Jalan Raja Muda Abdul Aziz, 50300, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Hamzaini Abdul', 'Initials': 'HA', 'LastName': 'Hamid', 'Affiliation': 'Department of Radiology, Faculty of Medicine, Universiti Kebangsaan Malaysia Medical Center, Jalan Yaacob Latif, Bandar Tun Razak, 56000 Batu 9 Cheras, Kuala Lumpur, Malaysia.'}]",BMC complementary medicine and therapies,['10.1186/s12906-020-03092-2']
1482,33076885,Design of a randomized controlled trial to evaluate effectiveness of methotrexate versus prednisone as first-line treatment for pulmonary sarcoidosis: the PREDMETH study.,"BACKGROUND


Treatment of pulmonary sarcoidosis is recommended in case of significant symptoms, impaired or deteriorating lung function. Evidence-based treatment recommendations are limited and largely based on expert opinion. Prednisone is currently the first-choice therapy and leads to short-term improvement of lung function. Unfortunately, prednisone often has side-effects and may be associated with impaired quality of life. Methotrexate is presently considered second-line therapy, and appears to have fewer side-effects.
OBJECTIVE


The primary objective of this trial is to investigate the effectiveness and tolerability of methotrexate as first-line therapy in patients with pulmonary sarcoidosis compared with prednisone. The primary endpoint of this study will be the change in hospital-measured Forced Vital Capacity (FVC) between baseline and 24 weeks. Secondary objectives are to gain more insights in response to therapy in individual patients by home spirometry and patient-reported outcomes. Blood biomarkers will be examined to find predictors of response to therapy, disease progression and chronicity, and to improve our understanding of the underlying disease mechanism.
METHODS/DESIGN


In this prospective, randomized, non-blinded, multi-center, non-inferiority trial, we plan to randomize 138 treatment-naïve patients with pulmonary sarcoidosis who are about to start treatment. Patients will be randomized in a 1:1 ratio to receive either prednisone or methotrexate in a predefined schedule for 24 weeks, after which they will be followed up in regular care for up to 2 years. Regular hospital visits will include pulmonary function assessment, completion of patient-reported outcomes, and blood withdrawal. Additionally, patients will be asked to perform weekly home spirometry, and record symptoms and side-effects via a home monitoring application for 24 weeks.
DISCUSSION


This study will be the first randomized controlled trial comparing first-line treatment of prednisone and methotrexate and provide valuable data on efficacy, safety, quality of life and biomarkers. If this study confirms the hypothesis that methotrexate is as effective as prednisone as first-line treatment for sarcoidosis but with fewer side-effects, this will lead to improvement in care and initiate a change in practice. Furthermore, insights into the immunological mechanisms underlying sarcoidosis pathology might reveal new therapeutic targets.
TRIAL REGISTRATION


The study was registered on the 19th of March 2020 in the International Clinical Trial Registry, www.clinicaltrials.gov; ID NCT04314193 .",2020,The primary endpoint of this study will be the change in hospital-measured Forced Vital Capacity (FVC) between baseline and 24 weeks.,"['pulmonary sarcoidosis', 'patients with pulmonary sarcoidosis compared with', '138 treatment-naïve patients with pulmonary sarcoidosis who are about to start treatment']","['prednisone', 'methotrexate', 'Methotrexate', 'Prednisone', 'methotrexate versus prednisone', 'prednisone or methotrexate', 'prednisone and methotrexate']","['efficacy, safety, quality of life and biomarkers', 'effectiveness and tolerability', 'change in hospital-measured Forced Vital Capacity (FVC']","[{'cui': 'C0036205', 'cui_str': 'Pulmonary sarcoidosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3874886', 'cui_str': 'Is about'}, {'cui': 'C0439659', 'cui_str': 'Origins'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}]",,0.0953442,The primary endpoint of this study will be the change in hospital-measured Forced Vital Capacity (FVC) between baseline and 24 weeks.,"[{'ForeName': 'Vivienne', 'Initials': 'V', 'LastName': 'Kahlmann', 'Affiliation': 'Department of Respiratory Medicine, Centre of Excellence for Interstitial Lung Diseases and Sarcoidosis, Erasmus Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Montse', 'Initials': 'M', 'LastName': 'Janssen Bonás', 'Affiliation': 'Department of Pulmonology, ILD Center of Excellence, St. Antonius Hospital, Nieuwegein, the Netherlands.'}, {'ForeName': 'Catharina C', 'Initials': 'CC', 'LastName': 'Moor', 'Affiliation': 'Department of Respiratory Medicine, Centre of Excellence for Interstitial Lung Diseases and Sarcoidosis, Erasmus Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Coline H M', 'Initials': 'CHM', 'LastName': 'van Moorsel', 'Affiliation': 'Department of Pulmonology, ILD Center of Excellence, St. Antonius Hospital, Nieuwegein, the Netherlands.'}, {'ForeName': 'Mirjam', 'Initials': 'M', 'LastName': 'Kool', 'Affiliation': 'Department of Respiratory Medicine, Centre of Excellence for Interstitial Lung Diseases and Sarcoidosis, Erasmus Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Raisa', 'Initials': 'R', 'LastName': 'Kraaijvanger', 'Affiliation': 'Department of Pulmonology, ILD Center of Excellence, St. Antonius Hospital, Nieuwegein, the Netherlands.'}, {'ForeName': 'Jan C', 'Initials': 'JC', 'LastName': 'Grutters', 'Affiliation': 'Department of Pulmonology, ILD Center of Excellence, St. Antonius Hospital, Nieuwegein, the Netherlands.'}, {'ForeName': 'Mayka', 'Initials': 'M', 'LastName': 'Overgaauw', 'Affiliation': 'Sarcoidosis patient association, Sarcoidose.nl, Alkmaar, the Netherlands.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Veltkamp', 'Affiliation': 'Department of Pulmonology, ILD Center of Excellence, St. Antonius Hospital, Nieuwegein, the Netherlands.'}, {'ForeName': 'Marlies S', 'Initials': 'MS', 'LastName': 'Wijsenbeek', 'Affiliation': 'Department of Respiratory Medicine, Centre of Excellence for Interstitial Lung Diseases and Sarcoidosis, Erasmus Medical Center, Rotterdam, the Netherlands. m.wijsenbeek-lourens@erasmusmc.nl.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMC pulmonary medicine,['10.1186/s12890-020-01290-9']
1483,33076888,Comparison of efficacy of corticosteroid injection versus extracorporeal shock wave therapy on inferior trigger points in the quadratus lumborum muscle: a randomized clinical trial.,"BACKGROUND


In this study, we aimed to compare the efficacy of corticosteroid trigger point injection (TPI) versus extracorporeal shock wave therapy (ESWT) on inferior trigger points in the quadratus lumborum (QL) muscle.
METHODS


In this single-blind randomized clinical trial, 54 low back pain patients with myofascial trigger points on QL muscle were investigated. Participants were randomly allocated into two groups with A and B pockets. Patients in group A underwent radial ESWT and received 5 treatment sessions (1 per week) and actually were not followed-up. However, patients in group B received corticosteroid TPI and received one session of corticosteroid treatment and followed-up for 4 weeks after injection. Oswestry Disability Index (ODI), visual analogue scale (VAS), pain pressure threshold (PPT) and short form (36) health survey (SF-36) were measured in both groups before, two weeks after and four weeks after intervention.
RESULTS


The between group comparison indicated that corticosteroid TPI leaded to significant higher improvements of ODI (P-value< 0.01), VAS (P value< 0.001), and PPT (P-value = 0.001) scores compared to the ESWT group at two-week follow-up time-point. ESWT group recorded significant higher improvement of ODI (P-value< 0.01) and SF-36 (P-value< 0.001) compared to the corticosteroid TPI at 4th week post treatment evaluation. At four-week follow-up time-point, the patients in the ESWT group were 1.46 times more likely to achieve 30% reduction in VAS, 2.67 times more likely to achieve 30% reduction in ODI, and 2.30 times more likely to achieve 20% improvement in SF-36 compared to the participants in corticosteroid TPI group. These results refer to large effect size for all study outcomes in ESWT group (d = 4.72, d = 1.58, d = 5.48, and d = 7.47 for ODI, PPT, SF-36, and VAS, respectively).
CONCLUSION


Corticosteroid TPI was more effective compared to ESWT in short-term controlling of pain and disability caused by myofascial pain syndrome of QL muscle. However, after 4 weeks treatment, ESWT further improved the quality of life and disability and was related with more probability of achievement the minimal clinically important difference concerning pain, disability and quality of life and large effect size for all study outcomes in treated patients compared to corticosteroid TPI.
TRIAL REGISTRATION


www.irct.ir , IRCT20100827004641N14 , retrospectively registered 2019-01-19.",2020,ESWT group recorded significant higher improvement of ODI (P-value< 0.01) and SF-36 (P-value< 0.001) compared to the corticosteroid TPI at 4th week post treatment evaluation.,"['quadratus lumborum muscle', '54 low back pain patients with myofascial trigger points on QL muscle']","['corticosteroid injection', 'radial ESWT', 'corticosteroid TPI', 'corticosteroid trigger point injection (TPI) versus extracorporeal shock wave therapy (ESWT', 'Corticosteroid TPI', 'extracorporeal shock wave therapy', 'ESWT']","['quality of life and disability', 'Oswestry Disability Index (ODI), visual analogue scale (VAS), pain pressure threshold (PPT) and short form (36) health survey (SF-36', 'ODI', 'VAS', 'SF-36', 'pain, disability and quality of life and large effect size']","[{'cui': 'C0224380', 'cui_str': 'Structure of quadratus lumborum muscle'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0458343', 'cui_str': 'Trigger point'}]","[{'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C1737238', 'cui_str': 'Extracorporeal shock wave therapy'}, {'cui': 'C0185340', 'cui_str': 'Injection of trigger points'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}]",54.0,0.0740207,ESWT group recorded significant higher improvement of ODI (P-value< 0.01) and SF-36 (P-value< 0.001) compared to the corticosteroid TPI at 4th week post treatment evaluation.,"[{'ForeName': 'Bina', 'Initials': 'B', 'LastName': 'Eftekharsadat', 'Affiliation': 'Physical Medicine and Rehabilitation Research Center, Aging Research Institute, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Negar', 'Initials': 'N', 'LastName': 'Fasaie', 'Affiliation': 'Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Dina', 'Initials': 'D', 'LastName': 'Golalizadeh', 'Affiliation': 'Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Babaei-Ghazani', 'Affiliation': 'Neuromusculoskeletal Research Center, Department of physical medicine and rehabilitation, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Jahanjou', 'Affiliation': 'Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Yashar', 'Initials': 'Y', 'LastName': 'Eslampoor', 'Affiliation': 'Palliative Care Medicine Department, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'Dolatkhah', 'Affiliation': 'Physical Medicine and Rehabilitation Research Center, Aging Research Institute, Tabriz University of Medical Sciences, Tabriz, Iran. neda_dolatkhah@yahoo.com.'}]",BMC musculoskeletal disorders,['10.1186/s12891-020-03714-3']
1484,33076902,Analysis of low-dose estrogen on callus BMD as measured by pQCT in postmenopausal women.,"BACKGROUND


Osteoporosis affects elderly patients of both sexes. It is characterized by an increased fracture risk due to defective remodeling of the bone microarchitecture. It affects in particular postmenopausal women due to their decreased levels of estrogen. Preclinical studies with animals demonstrated that loss of estrogen had a negative effect on bone healing and that increasing the estrogen level led to a better bone healing. We asked whether increasing the estrogen level in menopausal patients has a beneficial effect on bone mineral density (BMD) during callus formation after a bone fracture.
METHODS


To investigate whether estrogen has a beneficial effect on callus BMD of postmenopausal patients, we performed a prospective double-blinded randomized study with 76 patients suffering from distal radius fractures. A total of 31 patients (71.13 years ±11.99) were treated with estrogen and 45 patients (75.62 years ±10.47) served as untreated controls. Calculated bone density as well as cortical bone density were determined by peripheral quantitative computed tomography (pQCT) prior to and 6 weeks after the surgery. Comparative measurements were performed at the fractured site and at the corresponding position of the non-fractured arm.
RESULTS


We found that unlike with preclinical models, bone fracture healing of human patients was not improved in response to estrogen treatment. Furthermore, we observed no dependence between age-dependent bone tissue loss and constant callus formation in the patients.
CONCLUSIONS


Transdermally applied estrogen to postmenopausal women, which results in estrogen levels similar to the systemic level of premenopausal women, has no significant beneficial effect on callus BMD as measured by pQCT, as recently shown in preclinical animal models.
TRIAL REGISTRATION


Low dose estrogen has no significant effect on bone fracture healing measured by pQCT in postmenopausal women, DRKS00019858 . Registered 25th November 2019 - Retrospectively registered. Trial registration number DRKS00019858 .",2020,"TRIAL REGISTRATION


Low dose estrogen has no significant effect on bone fracture healing measured by pQCT in postmenopausal women, DRKS00019858 .","['particular postmenopausal women', 'menopausal patients', 'postmenopausal women', 'postmenopausal patients', '31 patients (71.13\u2009years ±11.99) were treated with estrogen and 45 patients (75.62\u2009years ±10.47) served as untreated controls', '76 patients suffering from distal radius fractures', 'Osteoporosis affects elderly patients of both sexes', 'November 2019']",['estrogen'],"['bone healing', 'bone mineral density (BMD', 'bone tissue loss and constant callus formation', 'fracture risk', 'cortical bone density', 'Calculated bone density', 'bone fracture healing', 'callus BMD']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0014939', 'cui_str': 'Estrogens'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}]","[{'cui': 'C0014939', 'cui_str': 'Estrogens'}]","[{'cui': 'C1321023', 'cui_str': 'Bone healing status'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0391978', 'cui_str': 'Bone (tissue) structure'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0006767', 'cui_str': 'Callus of bone'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0222652', 'cui_str': 'Cortex of bone'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}]",76.0,0.0820602,"TRIAL REGISTRATION


Low dose estrogen has no significant effect on bone fracture healing measured by pQCT in postmenopausal women, DRKS00019858 .","[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Jäckle', 'Affiliation': 'Department of Trauma Surgery, Orthopaedics and Plastic Surgery, University Medical Center Göttingen, Robert-Koch Str. 40, 37075, Göttingen, Germany. katharina.jaeckle@med.uni-goettingen.de.'}, {'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Kolb', 'Affiliation': 'Department of Trauma and Orthopaedic Surgery, University Medical Center Hamburg-Eppendorf, Martinistrasse 52, 20246, Hamburg, Germany.'}, {'ForeName': 'A F', 'Initials': 'AF', 'LastName': 'Schilling', 'Affiliation': 'Department of Trauma Surgery, Orthopaedics and Plastic Surgery, University Medical Center Göttingen, Robert-Koch Str. 40, 37075, Göttingen, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Schlickewei', 'Affiliation': 'Department of Trauma and Orthopaedic Surgery, University Medical Center Hamburg-Eppendorf, Martinistrasse 52, 20246, Hamburg, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Amling', 'Affiliation': 'Center for Biomechanics and Skeletal Biology, University Medical Center Hamburg-Eppendorf, Martinistrasse 52, 20246, Hamburg, Germany.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Rueger', 'Affiliation': 'Department of Trauma, Hand and Reconstructive Surgery, University Medical Center Hamburg-Eppendorf, Martinistrasse 52, 20246, Hamburg, Germany.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Lehmann', 'Affiliation': 'Department of Trauma Surgery, Orthopaedics and Plastic Surgery, University Medical Center Göttingen, Robert-Koch Str. 40, 37075, Göttingen, Germany.'}]",BMC musculoskeletal disorders,['10.1186/s12891-020-03713-4']
1485,33076932,The impact of hypothetical PErsonalised Risk Information on informed choice and intention to undergo Colorectal Cancer screening colonoscopy in Scotland (PERICCS)-a randomised controlled trial.,"BACKGROUND


There is currently no existing evidence on the effects of personalised risk information on uptake of colonoscopy following first line screening for colorectal cancer. This study aimed to measure the impact of providing risk information based on faecal haemoglobin concentration to allow a fully informed choice around whether or not to undergo colonoscopy.
METHODS


Two thousand seven hundred sixty-seven participants from the Scottish Bowel Screening Programme (SBoSP) database, who had not recently been invited for screening, were randomised to receive one of three types of hypothetical risk information materials: (1) numerical risk information (risk categories of one in 40, one in 1600 and one in 3500), (2) categorical risk information (highest, moderate and lowest risk), or (3) positive screening result letter (control group). The primary outcome was the impact of the risk materials on intention to undergo colonoscopy, to allow comparison with the current colonoscopy uptake of 77% for those with a positive screening result in the SBoSP. Secondary outcomes were knowledge, attitudes and emotional responses to the materials.
RESULTS


Four hundred thirty-four (15.7%) agreed to participate with 100 from the numerical risk group (69.0%), 104 from the categorical risk group (72.2%) and 104 from the control group (71.7%) returning completed materials. Intention to undergo colonoscopy was highest in the highest risk groups for the numerical and categorical study arms (96.8% and 95.3%, respectively), but even in the lowest risk groups was > 50% (58.1% and 60.7%, respectively). Adequate knowledge of colorectal screening and the risks and benefits of colonoscopy was found in ≥ 98% of participants in all three arms. All participants reported that they found the information easy-to-understand. 19.1%, 24.0% and 29.6% of those in the numerical, categorical and control group, respectively, reported that they found the information distressing (p > 0.05).
CONCLUSIONS


Applying the risk categories to existing SBoSP data shows that if all participants were offered an informed choice to have colonoscopy, over two thirds of participants would intend to have the test. Equating to an increase in the number of screening colonoscopies from approx. 14,000 to 400,000 per annum, this would place an unmanageable demand on colonoscopy services, with a very small proportion of cancers and pre-cancers detected. However, the response to the materials were very positive, suggesting that providing risk information to those in lowest and moderate risk groups along with advice that colonoscopy is not currently recommended may be an option. Future research would be required to examine actual uptake.
TRIAL REGISTRATION


Date applied 1 December 2017 ISRCTN number 14254582 .",2020,Adequate knowledge of colorectal screening and the risks and benefits of colonoscopy was found in ≥ 98% of participants in all three arms.,"['Two thousand seven hundred sixty-seven participants from the Scottish Bowel Screening Programme (SBoSP) database, who had not recently been invited for screening', 'Four hundred thirty-four (15.7%) agreed to participate with 100 from the numerical risk group (69.0%), 104 from the categorical risk group (72.2%) and 104 from the control group (71.7%) returning completed materials', 'colorectal cancer']","['hypothetical PErsonalised Risk Information', 'hypothetical risk information materials: (1) numerical risk information (risk categories of one in 40, one in 1600 and one in 3500), (2) categorical risk information (highest, moderate and lowest risk), or (3) positive screening result letter (control group']","['knowledge, attitudes and emotional responses to the materials', 'Intention to undergo colonoscopy', 'information distressing', 'impact of the risk materials on intention to undergo colonoscopy, to allow comparison with the current colonoscopy uptake']","[{'cui': 'C4517675', 'cui_str': '2700'}, {'cui': 'C4517852', 'cui_str': '67'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C4517592', 'cui_str': '1600'}, {'cui': 'C4517736', 'cui_str': '3500'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0521116', 'cui_str': 'Current'}]",2767.0,0.0988196,Adequate knowledge of colorectal screening and the risks and benefits of colonoscopy was found in ≥ 98% of participants in all three arms.,"[{'ForeName': 'Jayne', 'Initials': 'J', 'LastName': 'Digby', 'Affiliation': 'Centre for Research into Cancer Prevention and Screening, University of Dundee, Ninewells Hospital and Medical School, Dundee, DD1 9SY, Scotland, UK. jaynedigby@nhs.net.'}, {'ForeName': 'Ronan E', 'Initials': 'RE', 'LastName': ""O'Carroll"", 'Affiliation': 'Division of Psychology, University of Stirling, Stirling, FK9 4LA, Scotland, UK.'}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Chambers', 'Affiliation': 'Division of Psychology, University of Stirling, Stirling, FK9 4LA, Scotland, UK.'}, {'ForeName': 'Robert J C', 'Initials': 'RJC', 'LastName': 'Steele', 'Affiliation': 'Centre for Research into Cancer Prevention and Screening, University of Dundee, Ninewells Hospital and Medical School, Dundee, DD1 9SY, Scotland, UK.'}]",BMC medicine,['10.1186/s12916-020-01750-3']
1486,33076939,Effect of early prophylactic low-dose recombinant human erythropoietin on retinopathy of prematurity in very preterm infants.,"BACKGROUND


Very preterm infants are at risk of developing retinopathy of prematurity (ROP). Recombinant human erythropoietin (rhEPO) is routinely used to prevent anemia in preterm infants; however, the effect of rhEPO on ROP development is still controversial. The purpose of this study was to evaluate the effect of early prophylactic low-dose rhEPO administration on ROP development in very preterm infants.
METHODS


A total of 1898 preterm infants born before 32 weeks of gestation were included. Preterm infants received rhEPO (n = 950; 500 U/kg, rhEPO group) or saline (n = 948, control group) intravenously within 72 h of birth and then once every other day for 2 weeks.
RESULTS


The total incidence of ROP was not significantly different between the two groups (10.2% vs. 13.2%, p = 0.055). Further analysis showed that rhEPO group had lower rates of type 2 ROP than the control group (2.2% vs. 4.1%, RR 0.98; 95% CI 0.96-1.00; p = 0.021). Subgroup analysis found that rhEPO treatment significantly decreased the incidence of type 2 ROP in infant boys (1.8% vs. 4.3%, p = 0.021) and in those with a gestational age of 28-29 6/7  weeks (1.1% vs. 4.9%, p = 0.002) and birth weight of 1000-1499 g (1.2% vs. 4.2%, p = 0.002). There was a small increasing tendency for the incidence of ROP in infants with a gestational age of < 28 weeks after rhEPO treatment.
CONCLUSIONS


Repeated low-dose rhEPO administration has no significant influence on the development of ROP; however, it may be effective for type 2 ROP in infant boys or in infants with gestational age > 28 weeks and birth weight > 1500 g. Trial registration The data of this study were retrieved from two clinical studies registered ClinicalTrials.gov (NCT02036073) on January 14, 2014, https://clinicaltrials.gov/ct2/show/NCT02036073 ; and (NCT03919500) on April 18, 2019. https://clinicaltrials.gov/ct2/show/NCT03919500 .",2020,"The total incidence of ROP was not significantly different between the two groups (10.2% vs. 13.2%, p = 0.055).","['preterm infants', 'very preterm infants', 'infants with a gestational age of\u2009<\u200928\xa0weeks after rhEPO treatment', 'infant boys or in infants with gestational age\u2009', '1898 preterm infants born before 32\xa0weeks of gestation were included', '28\xa0weeks and birth weight\u2009>\u20091500']","['early prophylactic low-dose rhEPO', 'saline', 'Recombinant human erythropoietin (rhEPO', 'early prophylactic low-dose recombinant human erythropoietin', 'rhEPO']","['rates of type 2 ROP', 'incidence of ROP', 'birth weight', 'ROP development', 'retinopathy of prematurity', 'ROP', 'total incidence of ROP', 'incidence of type 2 ROP']","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C3897192', 'cui_str': 'Very preterm infant'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0014822', 'cui_str': 'erythropoietin'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C4517582', 'cui_str': '1500'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0014822', 'cui_str': 'erythropoietin'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0035344', 'cui_str': 'Retinopathy of prematurity'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",1898.0,0.134376,"The total incidence of ROP was not significantly different between the two groups (10.2% vs. 13.2%, p = 0.055).","[{'ForeName': 'Huiqing', 'Initials': 'H', 'LastName': 'Sun', 'Affiliation': ""Department of Neonatology, Children's Hospital Affiliated to Zhengzhou University, Henan Children's Hospital, Zhengzhou Children's Hospital, Zhengzhou, China.""}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Song', 'Affiliation': 'Henan Key Laboratory of Child Brain Injury, Institute of Neuroscience and Third Affiliated Hospital, Zhengzhou University, Zhengzhou, 450052, China.'}, {'ForeName': 'Wenqing', 'Initials': 'W', 'LastName': 'Kang', 'Affiliation': ""Department of Neonatology, Children's Hospital Affiliated to Zhengzhou University, Henan Children's Hospital, Zhengzhou Children's Hospital, Zhengzhou, China.""}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Henan Key Laboratory of Child Brain Injury, Institute of Neuroscience and Third Affiliated Hospital, Zhengzhou University, Zhengzhou, 450052, China.'}, {'ForeName': 'Xiantao', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': ""Department of Ophthalmology, Children's Hospital Affiliated to Zhengzhou University, Henan Children's Hospital, Zhengzhou, China.""}, {'ForeName': 'Chongchen', 'Initials': 'C', 'LastName': 'Zhou', 'Affiliation': ""Key Laboratories of Children's Genetic Metabolic Diseases, Henan Province, Children's Hospital Affiliated to Zhengzhou University, Henan Children's Hospital, Zhengzhou, China.""}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Xiong', 'Affiliation': ""Department of Neonatology, Children's Hospital Affiliated to Zhengzhou University, Henan Children's Hospital, Zhengzhou Children's Hospital, Zhengzhou, China.""}, {'ForeName': 'Falin', 'Initials': 'F', 'LastName': 'Xu', 'Affiliation': 'Henan Key Laboratory of Child Brain Injury, Institute of Neuroscience and Third Affiliated Hospital, Zhengzhou University, Zhengzhou, 450052, China.'}, {'ForeName': 'Mingchao', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': ""Department of Neonatology, Children's Hospital Affiliated to Zhengzhou University, Henan Children's Hospital, Zhengzhou Children's Hospital, Zhengzhou, China.""}, {'ForeName': 'Xiaoli', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Henan Key Laboratory of Child Brain Injury, Institute of Neuroscience and Third Affiliated Hospital, Zhengzhou University, Zhengzhou, 450052, China.'}, {'ForeName': 'Zengyuan', 'Initials': 'Z', 'LastName': 'Yu', 'Affiliation': ""Department of Neonatology, Children's Hospital Affiliated to Zhengzhou University, Henan Children's Hospital, Zhengzhou Children's Hospital, Zhengzhou, China.""}, {'ForeName': 'Xirui', 'Initials': 'X', 'LastName': 'Peng', 'Affiliation': 'Henan Key Laboratory of Child Brain Injury, Institute of Neuroscience and Third Affiliated Hospital, Zhengzhou University, Zhengzhou, 450052, China.'}, {'ForeName': 'Bingbing', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': 'Henan Key Laboratory of Child Brain Injury, Institute of Neuroscience and Third Affiliated Hospital, Zhengzhou University, Zhengzhou, 450052, China.'}, {'ForeName': 'Yiran', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Henan Key Laboratory of Child Brain Injury, Institute of Neuroscience and Third Affiliated Hospital, Zhengzhou University, Zhengzhou, 450052, China.'}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Xing', 'Affiliation': ""Department of Neonatology, Children's Hospital Affiliated to Zhengzhou University, Henan Children's Hospital, Zhengzhou Children's Hospital, Zhengzhou, China.""}, {'ForeName': 'Xiaoyang', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Henan Key Laboratory of Child Brain Injury, Institute of Neuroscience and Third Affiliated Hospital, Zhengzhou University, Zhengzhou, 450052, China.'}, {'ForeName': 'Changlian', 'Initials': 'C', 'LastName': 'Zhu', 'Affiliation': 'Henan Key Laboratory of Child Brain Injury, Institute of Neuroscience and Third Affiliated Hospital, Zhengzhou University, Zhengzhou, 450052, China. changlian.zhu@neuro.gu.se.'}]",Journal of translational medicine,['10.1186/s12967-020-02562-y']
1487,33076950,Is changing the postoperative pain management in total knee arthroplasty from femoral nerve block to local infiltration analgesia successful? Retrospective trial with the first and last 100 patients.,"PURPOSE


In recent years, there has been an increasing interest in local infiltration analgesia (LIA) as a technique to control postoperative pain. We compared this technique to the gold standard the 3 in 1 femoral nerve block (FNB) in postoperative pain management after total knee arthroplasty (TKA) in a large patient population. This trial analyzes in the early postoperative phase the pain, range of motion, and consumption of pain medications after TKA.
METHODS


We conducted a retrospective trial that included all patients who were undergoing primary TKA by one single surgeon in a high-volume arthroplasty center in 2015. Patients who have secondary osteoarthritis due to rheumatoid arthritis or previous knee arthrotomy, as well as revision cases, were excluded. The included patients were divided into 2 groups according to the applied pain management (group 1 FNB, group 2 LIA). Concerning the LIA group, a modified form of composition compared to the first describer without the use of adrenaline was carried out. Post-operative additional pain medications were given on a fixed scheme to the patient. The primary outcome was pain at rest over 7 days after surgery labeled by the numeric pain rating scale (NRS). The secondary outcome measures were the total amount of opioid consumption over the hospital stay and the additional need for non-opioid medication. The conversion of the opiate medications on the morphine preparation was carried out according to the conversion data from the literature. For functional recovery, we compared the range of motion in both groups, which was recorded from the second postoperative day by the attending physiotherapist.
RESULTS


In total, 202 patients were assessed for eligibility and included in this clinical trial. Hundred patients were allocated to the continuous FNB group (group 1) and 102 patients to the LIA group (group 2). No statistical difference was found between the two groups regarding demographic data. Primary outcome measurements: The LIA group had a significantly lower NRS score than the continuous FNB group for the measurement in the morning on days 1, 2, and 3 after surgery (day 1, 1.5; day 2, 1.6; day 3, 1.3; p < 0.05). Secondary outcome measurements: The total volume of morphine consumption for the first six postoperative days was significantly lower in the LIA group than the FNB group (FNB 159.8 vs. LIA 96.07). There is also a significant difference between the total morphine consumption of both groups in the direct postoperative course with respect to time and group (two way ANOVA, p < 0.05) On the day of the operation and on the first postoperative day, the intake of additional non-opioids in the LIA group was also significantly reduced compared to the FNB group. No significant difference was observed on the second to sixth postoperative day concerning an additional consumption of non-opioid medications. In terms of range of motion, the LIA group showed a higher active range of motion at the operated extremity than the FNB group during the hospital stay.
CONCLUSION


The local intraarticular infiltration therapy (LIA) is a sufficient alternative to regional anesthesia avoiding the known risks of regional procedures. The results of this study reflect the efficiency of this pain management with a lower consumption of analgesics, identical to reduced postoperative pain ratings and an improved ROM in the first postoperative days.
LEVEL OF EVIDENCE


Retrospective trial.",2020,The local intraarticular infiltration therapy (LIA) is a sufficient alternative to regional anesthesia avoiding the known risks of regional procedures.,"['Hundred patients', 'included all patients who were undergoing primary TKA by one single surgeon in a high-volume arthroplasty center in 2015', '100 patients', '202 patients were assessed for eligibility and included in this clinical trial', 'postoperative pain management after total knee arthroplasty (TKA) in a large patient population', 'Patients who have secondary osteoarthritis due to rheumatoid arthritis or previous knee arthrotomy, as well as revision cases, were excluded']","['applied pain management', 'LIA', 'adrenaline', 'local intraarticular infiltration therapy (LIA', 'femoral nerve block (FNB', 'continuous FNB']","['total morphine consumption', 'total volume of morphine consumption for the first six postoperative days', 'pain, range of motion, and consumption of pain medications', 'total amount of opioid consumption over the hospital stay and the additional need for non-opioid medication', 'additional consumption of non-opioid medications', 'NRS score', 'pain at rest over 7\u2009days after surgery labeled by the numeric pain rating scale (NRS', 'postoperative pain ratings']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0003893', 'cui_str': 'Arthroplasty'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C2732281', 'cui_str': 'Secondary osteoarthritis'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0187811', 'cui_str': 'Arthrotomy of knee'}, {'cui': 'C0439616', 'cui_str': 'Revisions'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}]","[{'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0442108', 'cui_str': 'Intra-articular'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0394739', 'cui_str': 'Local anesthetic femoral nerve block'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0234253', 'cui_str': 'Rest pain'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}]",0.0,0.0390386,The local intraarticular infiltration therapy (LIA) is a sufficient alternative to regional anesthesia avoiding the known risks of regional procedures.,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Najfeld', 'Affiliation': 'OCM Orthopädische Chirurgie München, Steinerstr. 6, 81369, Munich, Germany. michael.najfeld@ocm-muenchen.de.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Hube', 'Affiliation': 'OCM Orthopädische Chirurgie München, Steinerstr. 6, 81369, Munich, Germany.'}, {'ForeName': 'Ann-Kathrin', 'Initials': 'AK', 'LastName': 'Kujat', 'Affiliation': 'Centrum für Muskuloskeletale Chirurgie, Campus Mitte Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Hermann Otto', 'Initials': 'HO', 'LastName': 'Mayr', 'Affiliation': 'Klinik für Orthopädie und Traumatologie, Universität Freiburg, Freiburg, Germany.'}, {'ForeName': 'Kathi', 'Initials': 'K', 'LastName': 'Thiele', 'Affiliation': 'Centrum für Muskuloskeletale Chirurgie, Campus Mitte Universitätsmedizin Berlin, Berlin, Germany.'}]",Journal of orthopaedic surgery and research,['10.1186/s13018-020-01981-3']
1488,33076952,A comparison of the effects and usability of two exoskeletal robots with and without robotic actuation for upper extremity rehabilitation among patients with stroke: a single-blinded randomised controlled pilot study.,"BACKGROUND


Robotic rehabilitation of stroke survivors with upper extremity dysfunction may yield different outcomes depending on the robot type. Considering that excessive dependence on assistive force by robotic actuators may interfere with the patient's active learning and participation, we hypothesised that the use of an active-assistive robot with robotic actuators does not lead to a more meaningful difference with respect to upper extremity rehabilitation than the use of a passive robot without robotic actuators. Accordingly, we aimed to evaluate the differences in the clinical and kinematic outcomes between active-assistive and passive robotic rehabilitation among stroke survivors.
METHODS


In this single-blinded randomised controlled pilot trial, we assigned 20 stroke survivors with upper extremity dysfunction (Medical Research Council scale score, 3 or 4) to the active-assistive robotic intervention (ACT) and passive robotic intervention (PSV) groups in a 1:1 ratio and administered 20 sessions of 30-min robotic intervention (5 days/week, 4 weeks). The primary (Wolf Motor Function Test [WMFT]-score and -time: measures activity), and secondary (Fugl-Meyer Assessment [FMA] and Stroke Impact Scale [SIS] scores: measure impairment and participation, respectively; kinematic outcomes) outcome measures were determined at baseline, after 2 and 4 weeks of the intervention, and 4 weeks after the end of the intervention. Furthermore, we evaluated the usability of the robots through interviews with patients, therapists, and physiatrists.
RESULTS


In both the groups, the WMFT-score and -time improved over the course of the intervention. Time had a significant effect on the WMFT-score and -time, FMA-UE, FMA-prox, and SIS-strength; group × time interaction had a significant effect on SIS-function and SIS-social participation (all, p < 0.05). The PSV group showed better improvement in participation and smoothness than the ACT group. In contrast, the ACT group exhibited better improvement in mean speed.
CONCLUSIONS


There were no differences between the two groups regarding the impairment and activity domains. However, the PSV robots were more beneficial than ACT robots regarding participation and smoothness. Considering the high cost and complexity of ACT robots, PSV robots might be more suitable for rehabilitation in stroke survivors capable of voluntary movement. Trial registration The trial was registered retrospectively on 14 March 2018 at ClinicalTrials.gov (NCT03465267).",2020,"Time had a significant effect on the WMFT-score and -time, FMA-UE, FMA-prox, and SIS-strength; group × time interaction had a significant effect on SIS-function and SIS-social participation (all, p < 0.05).","['stroke survivors with upper extremity dysfunction', '20 stroke survivors with upper extremity dysfunction (Medical Research Council scale score, 3 or 4) to the', 'patients with stroke']","['active-assistive robotic intervention (ACT) and passive robotic intervention (PSV) groups in a 1:1 ratio and administered 20 sessions of 30-min robotic intervention', 'exoskeletal robots with and without robotic actuation', 'active-assistive and passive robotic rehabilitation', 'ACT']","['WMFT]-score and -time: measures activity), and secondary (Fugl-Meyer Assessment [FMA] and Stroke Impact Scale [SIS] scores: measure impairment and participation, respectively; kinematic outcomes) outcome measures', 'WMFT-score and -time, FMA-UE, FMA-prox, and SIS-strength', 'SIS-function and SIS-social participation', 'mean speed', 'WMFT-score and -time']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C1698635', 'cui_str': 'Upper extremity dysfunction'}, {'cui': 'C0079816', 'cui_str': 'Research, Medical'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C4319628', 'cui_str': 'Actuation'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0814554', 'cui_str': 'Social Participation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}]",,0.113419,"Time had a significant effect on the WMFT-score and -time, FMA-UE, FMA-prox, and SIS-strength; group × time interaction had a significant effect on SIS-function and SIS-social participation (all, p < 0.05).","[{'ForeName': 'Jin Ho', 'Initials': 'JH', 'LastName': 'Park', 'Affiliation': 'Department of Rehabilitation Medicine, National Rehabilitation Center, Ministry of Health and Welfare, 58, Samgaksan-ro, Gangbuk-gu, Seoul, Republic of Korea.'}, {'ForeName': 'Gyulee', 'Initials': 'G', 'LastName': 'Park', 'Affiliation': 'Translational Research Program for Rehabilitation Robots, National Rehabilitation Center, Ministry of Health and Welfare, Seoul, Republic of Korea.'}, {'ForeName': 'Ha Yeon', 'Initials': 'HY', 'LastName': 'Kim', 'Affiliation': 'Translational Research Program for Rehabilitation Robots, National Rehabilitation Center, Ministry of Health and Welfare, Seoul, Republic of Korea.'}, {'ForeName': 'Ji-Yeong', 'Initials': 'JY', 'LastName': 'Lee', 'Affiliation': 'Department of Rehabilitation Medicine, National Rehabilitation Center, Ministry of Health and Welfare, 58, Samgaksan-ro, Gangbuk-gu, Seoul, Republic of Korea.'}, {'ForeName': 'Yeajin', 'Initials': 'Y', 'LastName': 'Ham', 'Affiliation': 'Department of Rehabilitation Medicine, National Rehabilitation Center, Ministry of Health and Welfare, 58, Samgaksan-ro, Gangbuk-gu, Seoul, Republic of Korea.'}, {'ForeName': 'Donghwan', 'Initials': 'D', 'LastName': 'Hwang', 'Affiliation': 'Translational Research Program for Rehabilitation Robots, National Rehabilitation Center, Ministry of Health and Welfare, Seoul, Republic of Korea.'}, {'ForeName': 'Suncheol', 'Initials': 'S', 'LastName': 'Kwon', 'Affiliation': 'Translational Research Program for Rehabilitation Robots, National Rehabilitation Center, Ministry of Health and Welfare, Seoul, Republic of Korea.'}, {'ForeName': 'Joon-Ho', 'Initials': 'JH', 'LastName': 'Shin', 'Affiliation': 'Department of Rehabilitation Medicine, National Rehabilitation Center, Ministry of Health and Welfare, 58, Samgaksan-ro, Gangbuk-gu, Seoul, Republic of Korea. asfreelyas@gmail.com.'}]",Journal of neuroengineering and rehabilitation,['10.1186/s12984-020-00763-6']
1489,33076964,"TREAT Early Arthralgia to Reverse or Limit Impending Exacerbation to Rheumatoid arthritis (TREAT EARLIER): a randomized, double-blind, placebo-controlled clinical trial protocol.","BACKGROUND


We present a study protocol for a randomized, double-blind, placebo-controlled trial that investigates the hypothesis if intervention in the symptomatic phase preceding clinical arthritis (clinically suspect arthralgia (CSA)) is effective in preventing progression from subclinical inflammation to clinically apparent persistent arthritis. Currently, rheumatoid arthritis (RA) can be recognized and diagnosed when arthritis (joint swelling) has become detectable at physical examination. Importantly, at this time, the immune processes have already matured, chronicity is established, and patients require long-standing treatment with disease-modifying anti-rheumatic drugs. The TREAT EARLIER trial studies the hypothesis that intervention in the symptomatic phase preceding clinical arthritis is more often successful in permanent disease modification because of less matured underlying disease processes.
METHODS


A two-level definition to identify patients that are prone to develop RA is used. First, patients should have CSA and recent-onset arthralgia (< 1 year) that is suspect to progress to RA according to the expertise of the treating rheumatologist. Second, patients need to have subclinical inflammation of the hand or foot joints at 1.5 T MRI. The trial aims to recruit 230 participants from secondary care hospital settings across the south-west region of The Netherlands. Intervention will be randomly assigned and includes a single-dose of intramuscular 120 mg methylprednisolon followed by methotrexate (increasing dose to 25 mg/week orally) or placebo (both; injection and tablets) over the course of 1 year. Thereafter, participants are followed for another year. The primary endpoint is the development of clinically detectable arthritis, either fulfilling the 2010 criteria for RA or unclassified clinical arthritis of ≥ 2 joints, which persists for at least 2 weeks. DMARD-free status is a co-primary endpoint. The patient-reported outcomes functioning, along with workability and symptoms, are key secondary endpoints. Participants, caregivers (including those assessing the endpoints), and scientific staff are all blinded to the group assignment.
DISCUSSION


This proof-of-concept study is the logical consequence of pre-work on the identification of patients with CSA with MRI-detected subclinical joint inflammation. It will test the hypothesis whether intervention in patients in this early phase with the cornerstone treatment of classified RA (methotrexate) hampers the development of persistent RA and reduce the disease burden of RA.
TRIAL REGISTRATION


Dutch Trial Register NL4599 (NTR4853). Registered on 20 October 2014.",2020,"The TREAT EARLIER trial studies the hypothesis that intervention in the symptomatic phase preceding clinical arthritis is more often successful in permanent disease modification because of less matured underlying disease processes.
","['patients with CSA with MRI-detected subclinical joint inflammation', 'symptomatic phase preceding clinical arthritis (clinically suspect arthralgia (CSA', '230 participants from secondary care hospital settings across the south-west region of The Netherlands']","['placebo', 'methylprednisolon followed by methotrexate']","['development of clinically detectable arthritis, either fulfilling the 2010 criteria for RA or unclassified clinical arthritis of ≥\u20092 joints']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010592', 'cui_str': 'Cyclosporine'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0205211', 'cui_str': 'Subclinical'}, {'cui': 'C0003864', 'cui_str': 'Arthritis'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0003862', 'cui_str': 'Joint pain'}, {'cui': 'C0337953', 'cui_str': 'Secondary care hospital'}, {'cui': 'C0037769', 'cui_str': 'West syndrome'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}]","[{'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0003864', 'cui_str': 'Arthritis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0205426', 'cui_str': 'Unclassified'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}]",230.0,0.598756,"The TREAT EARLIER trial studies the hypothesis that intervention in the symptomatic phase preceding clinical arthritis is more often successful in permanent disease modification because of less matured underlying disease processes.
","[{'ForeName': 'Ellis', 'Initials': 'E', 'LastName': 'Niemantsverdriet', 'Affiliation': 'Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands. E.Niemantsverdriet@lumc.nl.'}, {'ForeName': 'Yousra J', 'Initials': 'YJ', 'LastName': 'Dakkak', 'Affiliation': 'Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Leonie E', 'Initials': 'LE', 'LastName': 'Burgers', 'Affiliation': 'Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Femke', 'Initials': 'F', 'LastName': 'Bonte-Mineur', 'Affiliation': 'Department of Rheumatology, Maasstad Hospital, Rotterdam, The Netherlands.'}, {'ForeName': 'Gerda M', 'Initials': 'GM', 'LastName': 'Steup-Beekman', 'Affiliation': 'Department of Rheumatology, Haaglanden Medical Center - Bronovo, The Hague, The Netherlands.'}, {'ForeName': 'Sjoerd M', 'Initials': 'SM', 'LastName': 'van der Kooij', 'Affiliation': 'Department of Rheumatology, Haga Hospital, The Hague, The Netherlands.'}, {'ForeName': 'Hido D', 'Initials': 'HD', 'LastName': 'Boom', 'Affiliation': 'Department of Rheumatology, Spaarne Gasthuis, Haarlem, The Netherlands.'}, {'ForeName': 'Cornelia F', 'Initials': 'CF', 'LastName': 'Allaart', 'Affiliation': 'Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Pascal H P', 'Initials': 'PHP', 'LastName': 'de Jong', 'Affiliation': 'Department of Rheumatology, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Annette H M', 'Initials': 'AHM', 'LastName': 'van der Helm-van Mil', 'Affiliation': 'Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands.'}]",Trials,['10.1186/s13063-020-04731-2']
1490,33076981,What are the effects of supporting early parenting by newborn behavioral observations (NBO)? A cluster randomised trial.,"BACKGROUND


Professional support to enhance the early parent-infant relationship in the first months after birth is recommended, but little is known about the effect of universal interventions. The objective was to investigate the effect of health visitors' use of the Newborn Behavioral Observations system in new families.
METHODS


A cluster-randomised study was conducted in four Danish municipalities. Health visitors' geographical districts constituted the units for randomisation (n = 17). In the intervention group, 1332 families received NBO from 3 weeks after birth; in the comparison group, 1234 received usual care. Self-administered questionnaires were collected at baseline one to two weeks after birth, and at follow-up three and nine months postpartum. The outcomes were change over time measured by The Karitane Parenting Confidence Scale (KPCS), The Major Depression Inventory (MDI), The Ages and Stages Questionnaire: social-emotional (ASQ:SE) and The Mother and Baby Interaction Scale (MABIC). Data were analysed with mixed-effects linear regression using the intention-to-treat approach.
RESULTS


At baseline, no significant differences between the two groups were seen regarding maternal and infant factors. At follow-up three and nine months after birth, the change in maternal confidence and mood, infant's socio-emotional behaviour, and early parent-infant relationship moved in a slightly more positive direction in the intervention group than in the comparison group, though not statistically significant. The only significant effect was that the intervention mothers reported higher level of knowledge about infant's communication skills, response to cues, and how to sooth and establish a relation with the infant, compared to the comparison group.
CONCLUSIONS


We found no effect of the NBO system delivered in a universal context to all families in a community setting. The only significant difference between groups was a higher maternal degree of knowledge regarding early parenting in the intervention group.
TRIAL REGISTRATION


ClinicalTrials.gov ID: NCT03070652 . Registrated February 22, 2017.",2020,"The only significant effect was that the intervention mothers reported higher level of knowledge about infant's communication skills, response to cues, and how to sooth and establish a relation with the infant, compared to the comparison group.
","['A cluster-randomised study was conducted in four Danish municipalities', 'new families', ""Health visitors' geographical districts constituted the units for randomisation (n\u2009=\u200917""]","['NBO', 'Newborn Behavioral Observations system']","['maternal degree of knowledge regarding early parenting', ""maternal confidence and mood, infant's socio-emotional behaviour"", 'change over time measured by The Karitane Parenting Confidence Scale (KPCS), The Major Depression Inventory (MDI), The Ages and Stages Questionnaire: social-emotional (ASQ:SE) and The Mother and Baby Interaction Scale (MABIC', ""higher level of knowledge about infant's communication skills, response to cues, and how to sooth and establish a relation with the infant""]","[{'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0010969', 'cui_str': 'Danish language'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0018765', 'cui_str': 'Health Visitors'}, {'cui': 'C0439148', 'cui_str': 'Unit'}]","[{'cui': 'C0410422', 'cui_str': 'Chronic multifocal osteomyelitis'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0558039', 'cui_str': 'Observation of behavior'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0870313', 'cui_str': 'Communication skills'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0080103', 'cui_str': 'Relative'}]",,0.0825297,"The only significant effect was that the intervention mothers reported higher level of knowledge about infant's communication skills, response to cues, and how to sooth and establish a relation with the infant, compared to the comparison group.
","[{'ForeName': 'Ingeborg Hedegaard', 'Initials': 'IH', 'LastName': 'Kristensen', 'Affiliation': 'Nursing and Health Care, Department of Public Health, Aarhus University, Bartholins Allé 2, 8000, Aarhus C, Denmark. Ihk@ph.au.dk.'}, {'ForeName': 'Svend', 'Initials': 'S', 'LastName': 'Juul', 'Affiliation': 'Epidemiology, Department of Public Health, Aarhus University, Bartholins Allé 2, 8000, Aarhus C, Denmark.'}, {'ForeName': 'Hanne', 'Initials': 'H', 'LastName': 'Kronborg', 'Affiliation': 'Nursing and Health Care, Department of Public Health, Aarhus University, Bartholins Allé 2, 8000, Aarhus C, Denmark.'}]",BMC psychology,['10.1186/s40359-020-00467-5']
1491,33076983,The impact of a multi-domain intervention on cerebral glucose metabolism: analysis from the randomized ancillary FDG PET MAPT trial.,"BACKGROUND


The Multidomain Alzheimer Preventive Trial (MAPT) was designed to assess the efficacy of omega-3 fatty acid supplementation, multidomain intervention (MI), or a combination of both on cognition. Although the MAPT study was negative, an effect of MI in maintaining cognitive functions compared to placebo group was showed in positive amyloid subjects. A FDG PET study (MAPT-NI) was implemented to test the impact of MI on brain glucose metabolism.
METHODS


MAPT-NI was a randomized, controlled parallel-group single-center study, exploring the effect of MI on brain glucose metabolism. Participants were non-demented and had memory complaints, limitation in one instrumental activity of daily living, or slow gait. Participants were randomly assigned (1:1) to ""MI group"" or ""No MI group."" The MI consisted of group sessions focusing on 3 domains: cognitive stimulation, physical activity, nutrition, and a preventive consultation. [ 18 F]FDG PET scans were performed at baseline, 6 months, and 12 months, and cerebral magnetic resonance imaging scans at baseline. The primary objective was to evaluate the MI effect on brain glucose metabolism assessed by [ 18 F]FDG PET imaging at 6 months. The primary outcome was the quantification of regional metabolism rate for glucose in cerebral regions involved early in Alzheimer disease by relative semi-quantitative SUVr (FDG-based AD biomarker). An exploratory voxel-wise analysis was performed to assess the effect of MI on brain glucose metabolism without anatomical hypothesis.
RESULTS


The intention-to-treat population included 67 subjects (34 in the MI group and 33 in the No MI group. No significant MI effect was observed on primary outcome at 6 months. In the exploratory voxel-wise analysis, we observed a difference in favor of MI group on the change of cerebral glucose metabolism in limbic lobe (right hippocampus, right posterior cingulate, left posterior parahippocampal gyrus) at 6 months.
CONCLUSIONS


MI failed to show an effect on metabolism in FDG-based AD biomarker, but exploratory analysis suggested positive effect on limbic system metabolism. This finding could suggest a delay effect of MI on AD progression.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier, NCT01513252 .",2020,No significant MI effect was observed on primary outcome at 6 months.,"['MAPT-NI', '67 subjects (34 in the MI group and 33 in the No MI group', 'Participants were non-demented and had memory complaints, limitation in one instrumental activity of daily living, or slow gait']","['multi-domain intervention', 'placebo', 'omega-3 fatty acid supplementation, multidomain intervention (MI), or a combination of both on cognition', 'MI group"" or ""No MI group']","['quantification of regional metabolism rate for glucose in cerebral regions involved early in Alzheimer disease by relative semi-quantitative SUVr (FDG-based AD biomarker', 'MI effect on brain glucose metabolism', 'cognitive functions', 'limbic system metabolism', 'MI effect', 'cerebral glucose metabolism', 'brain glucose metabolism']","[{'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0860630', 'cui_str': 'Demented'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0150641', 'cui_str': 'Instrumental activities of daily living'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0016928', 'cui_str': 'Gait'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0561929', 'cui_str': 'N-3 fatty acid supplementation'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0522525', 'cui_str': 'Semi-quantitative'}, {'cui': 'C0046056', 'cui_str': 'Fluorodeoxyglucose F18'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0023715', 'cui_str': 'Limbic system structure'}]",67.0,0.326449,No significant MI effect was observed on primary outcome at 6 months.,"[{'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Delrieu', 'Affiliation': 'Pôle gériatrie, Cité de la santé, Place Lange - TSA 60033, 31059, Toulouse Cedex 9, France. delrieu.j@chu-toulouse.fr.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Voisin', 'Affiliation': 'INSERM UMR 1027, Toulouse, France; University of Toulouse III, Toulouse, France.'}, {'ForeName': 'Laure', 'Initials': 'L', 'LastName': 'Saint-Aubert', 'Affiliation': 'Toulouse NeuroImaging Center, University of Toulouse III, INSERM, UPS, Toulouse, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Carrie', 'Affiliation': 'Gérontopôle, Department of Geriatrics, Toulouse (University Hospital) CHU, Purpan University Hospital, Toulouse, France.'}, {'ForeName': 'Christelle', 'Initials': 'C', 'LastName': 'Cantet', 'Affiliation': 'INSERM UMR 1027, Toulouse, France; University of Toulouse III, Toulouse, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Vellas', 'Affiliation': 'INSERM UMR 1027, Toulouse, France; University of Toulouse III, Toulouse, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Payoux', 'Affiliation': 'Department of Nuclear Medicine, Toulouse CHU, Purpan University Hospital, Toulouse, France.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Andrieu', 'Affiliation': 'INSERM UMR 1027, Toulouse, France; University of Toulouse III, Toulouse, France.'}]",Alzheimer's research & therapy,['10.1186/s13195-020-00683-6']
1492,33076997,Implementation of a stepped wedge cluster randomized trial to evaluate a hospital mobility program.,"BACKGROUND


Stepped wedge cluster randomized trials (SW-CRT) are increasingly used to evaluate new clinical programs, yet there is limited guidance on practical aspects of applying this design. We report our early experiences conducting a SW-CRT to examine an inpatient mobility program (STRIDE) in the Veterans Health Administration (VHA). We provide recommendations for future research using this design to evaluate clinical programs.
METHODS


Based on data from study records and reflections from the investigator team, we describe and assess the design and initial stages of a SW-CRT, from site recruitment to program launch in 8 VHA hospitals.
RESULTS


Site recruitment consisted of thirty 1-h conference calls with representatives from 22 individual VAs who expressed interest in implementing STRIDE. Of these, 8 hospitals were enrolled and randomly assigned in two stratified blocks (4 hospitals per block) to a STRIDE launch date. Block 1 randomization occurred in July 2017 with first STRIDE launch in December 2017; block 2 randomization occurred in April 2018 with first STRIDE launch in January 2019. The primary study outcome of discharge destination will be assessed using routinely collected data in the electronic health record (EHR). Within randomized blocks, two hospitals per sequence launched STRIDE approximately every 3 months with primary outcome assessment paused during the 3-month time period of program launch. All sites received 6-8 implementation support calls, according to a pre-specified schedule, from the time of recruitment to program launch, and all 8 sites successfully launched within their assigned 3-month window. Seven of the eight sites initially started with a limited roll out (for example on one ward) or modified version of STRIDE (for example, using existing staff to conduct walks until new positions were filled).
CONCLUSIONS


Future studies should incorporate sufficient time for site recruitment and carefully consider the following to inform design of SW-CRTs to evaluate rollout of a new clinical program: (1) whether a blocked randomization fits study needs, (2) the amount of time and implementation support sites will need to start their programs, and (3) whether clinical programs are likely to include a ""ramp-up"" period. Successful execution of SW-CRT designs requires both adherence to rigorous design principles and also careful consideration of logistical requirements for timing of program roll out.
TRIAL REGISTRATION


ClinicalsTrials.gov NCT03300336 . Prospectively registered on 3 October 2017.",2020,We report our early experiences conducting a SW-CRT to examine an inpatient mobility program (STRIDE) in the Veterans Health Administration (VHA).,['Veterans Health Administration (VHA'],[],"['electronic health record (EHR', 'discharge destination']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0178672', 'cui_str': 'Health administration'}]",[],"[{'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}]",,0.116039,We report our early experiences conducting a SW-CRT to examine an inpatient mobility program (STRIDE) in the Veterans Health Administration (VHA).,"[{'ForeName': 'Susan N', 'Initials': 'SN', 'LastName': 'Hastings', 'Affiliation': 'Center of Innovation to Accelerate Discovery and Practice Transformation, Durham VA Health Care System, Durham, NC, USA. Susan.Hastings@va.gov.'}, {'ForeName': 'Karen M', 'Initials': 'KM', 'LastName': 'Stechuchak', 'Affiliation': 'Center of Innovation to Accelerate Discovery and Practice Transformation, Durham VA Health Care System, Durham, NC, USA.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Choate', 'Affiliation': 'Center of Innovation to Accelerate Discovery and Practice Transformation, Durham VA Health Care System, Durham, NC, USA.'}, {'ForeName': 'Elizabeth P', 'Initials': 'EP', 'LastName': 'Mahanna', 'Affiliation': 'Center of Innovation to Accelerate Discovery and Practice Transformation, Durham VA Health Care System, Durham, NC, USA.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Van Houtven', 'Affiliation': 'Center of Innovation to Accelerate Discovery and Practice Transformation, Durham VA Health Care System, Durham, NC, USA.'}, {'ForeName': 'Kelli D', 'Initials': 'KD', 'LastName': 'Allen', 'Affiliation': 'Center of Innovation to Accelerate Discovery and Practice Transformation, Durham VA Health Care System, Durham, NC, USA.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Wang', 'Affiliation': 'Center of Innovation to Accelerate Discovery and Practice Transformation, Durham VA Health Care System, Durham, NC, USA.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Sperber', 'Affiliation': 'Center of Innovation to Accelerate Discovery and Practice Transformation, Durham VA Health Care System, Durham, NC, USA.'}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Zullig', 'Affiliation': 'Center of Innovation to Accelerate Discovery and Practice Transformation, Durham VA Health Care System, Durham, NC, USA.'}, {'ForeName': 'Hayden B', 'Initials': 'HB', 'LastName': 'Bosworth', 'Affiliation': 'Center of Innovation to Accelerate Discovery and Practice Transformation, Durham VA Health Care System, Durham, NC, USA.'}, {'ForeName': 'Cynthia J', 'Initials': 'CJ', 'LastName': 'Coffman', 'Affiliation': 'Center of Innovation to Accelerate Discovery and Practice Transformation, Durham VA Health Care System, Durham, NC, USA.'}]",Trials,['10.1186/s13063-020-04764-7']
1493,33077004,Targeted gown and glove use to prevent  Staphylococcus aureus  acquisition in community-based nursing homes: A pilot study.,"OBJECTIVE


To test the feasibility of targeted gown and glove use by healthcare personnel caring for high-risk nursing-home residents to prevent Staphylococcus aureus acquisition in short-stay residents.
DESIGN


Uncontrolled clinical trial.
SETTING


This study was conducted in 2 community-based nursing homes in Maryland.
PARTICIPANTS


The study included 322 residents on mixed short- and long-stay units.
METHODS


During a 2-month baseline period, all residents had nose and inguinal fold swabs taken to estimate S. aureus acquisition. The intervention was iteratively developed using a participatory human factors engineering approach. During a 2-month intervention period, healthcare personnel wore gowns and gloves for high-risk care activities while caring for residents with wounds or medical devices, and S. aureus acquisition was measured again. Whole-genome sequencing was used to assess whether the acquisition represented resident-to-resident transmission.
RESULTS


Among short-stay residents, the methicillin-resistant S. aureus acquisition rate decreased from 11.9% during the baseline period to 3.6% during the intervention period (odds ratio [OR], 0.28; 95% CI, 0.08-0.92; P = .026). The methicillin-susceptible S. aureus acquisition rate went from 9.1% during the baseline period to 4.0% during the intervention period (OR, 0.41; 95% CI, 0.12-1.42; P = .15). The S. aureus resident-to-resident transmission rate decreased from 5.9% during the baseline period to 0.8% during the intervention period.
CONCLUSIONS


Targeted gown and glove use by healthcare personnel for high-risk care activities while caring for residents with wounds or medical devices, regardless of their S. aureus colonization status, is feasible and potentially decreases S. aureus acquisition and transmission in short-stay community-based nursing-home residents.",2020,"The S. aureus resident-to-resident transmission rate decreased from 5.9% during the baseline period to 0.8% during the intervention period.
","['2 community-based nursing homes in Maryland', '322 residents on mixed short- and long-stay units', 'community-based nursing homes', 'high-risk nursing-home residents']",['healthcare personnel wore gowns and gloves for high-risk care activities while caring'],"['transmission rate', 'methicillin-susceptible S. aureus acquisition rate', 'methicillin-resistant S. aureus acquisition rate']","[{'cui': 'C0009471', 'cui_str': 'Nursing, Community Health'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0024858', 'cui_str': 'Maryland'}, {'cui': 'C4517712', 'cui_str': '322'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}]","[{'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0181064', 'cui_str': 'Gown'}, {'cui': 'C0206069', 'cui_str': 'Glove'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]","[{'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0025643', 'cui_str': 'methicillin'}, {'cui': 'C0231204', 'cui_str': 'Susceptible'}, {'cui': 'C0038172', 'cui_str': 'Staphylococcus aureus'}, {'cui': 'C1955827', 'cui_str': 'Methicillin-Resistant'}]",322.0,0.0521733,"The S. aureus resident-to-resident transmission rate decreased from 5.9% during the baseline period to 0.8% during the intervention period.
","[{'ForeName': 'Alison D', 'Initials': 'AD', 'LastName': 'Lydecker', 'Affiliation': 'Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Patience A', 'Initials': 'PA', 'LastName': 'Osei', 'Affiliation': 'Armstrong Institute Center for Health Care Human Factors, Johns Hopkins School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Pineles', 'Affiliation': 'Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'J Kristie', 'Initials': 'JK', 'LastName': 'Johnson', 'Affiliation': 'Department of Pathology, University of Maryland School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Jacquelyn', 'Initials': 'J', 'LastName': 'Meisel', 'Affiliation': 'Center for Bioinformatics and Computational Biology, University of Maryland, College Park, Maryland.'}, {'ForeName': 'O Colin', 'Initials': 'OC', 'LastName': 'Stine', 'Affiliation': 'Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Magder', 'Affiliation': 'Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Ayse P', 'Initials': 'AP', 'LastName': 'Gurses', 'Affiliation': 'Armstrong Institute Center for Health Care Human Factors, Johns Hopkins School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Hebden', 'Affiliation': 'Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Cagla', 'Initials': 'C', 'LastName': 'Oruc', 'Affiliation': 'Armstrong Institute Center for Health Care Human Factors, Johns Hopkins School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Lona', 'Initials': 'L', 'LastName': 'Mody', 'Affiliation': 'Division of Geriatric and Palliative Care Medicine, University of Michigan Medical School, Ann Arbor, Michigan.'}, {'ForeName': 'Kara', 'Initials': 'K', 'LastName': 'Jacobs Slifka', 'Affiliation': 'Division of Healthcare Quality Promotion, Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Nimalie D', 'Initials': 'ND', 'LastName': 'Stone', 'Affiliation': 'Division of Healthcare Quality Promotion, Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Mary-Claire', 'Initials': 'MC', 'LastName': 'Roghmann', 'Affiliation': 'Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore, Maryland.'}]",Infection control and hospital epidemiology,['10.1017/ice.2020.1219']
1494,33077017,"Cellular dehydration acutely degrades mood mainly in women: a counterbalanced, crossover trial.","It is unclear if mild-to-moderate dehydration independently affects mood without confounders like heat exposure or exercise. This study examined the acute effect of cellular dehydration on mood. Forty-nine adults (55 % female, age 39 (sd 8) years) were assigned to counterbalanced, crossover trials. Intracellular dehydration was induced with 2-h (0·1 ml/kg per min) 3 % hypertonic saline (HYPER) infusion or 0·9 % isotonic saline (ISO) as a control. Plasma osmolality increased in HYPER (pre 285 (sd 3), post 305 (sd 4) mmol/kg; P < 0·05) but remained unchanged in ISO (pre 285 (sd 3), post 288 (sd 3) mmol/kg; P > 0·05). Mood was assessed with the short version of the Profile of Mood States Questionnaire (POMS). The POMS sub-scale (confusion-bewilderment, depression-dejection, fatigue-inertia) increased in HYPER compared with ISO (P < 0·05). Total mood disturbance score (TMD) assessed by POMS increased from 10·3 (sd 0·9) to 16·6 (sd 1·7) in HYPER (P < 0·01), but not in ISO (P > 0·05). When TMD was stratified by sex, the increase in the HYPER trial was significant in females (P < 0·01) but not in males (P > 0·05). Following infusion, thirst and copeptin (surrogate for vasopressin) were also higher in females than in males (21·3 (sd 2·0), 14·1 (sd 1·4) pmol/l; P < 0·01) during HYPER. In conclusion, cellular dehydration acutely degraded specific aspects of mood mainly in women. The mechanisms underlying sex differences may be related to elevated thirst and vasopressin.",2020,"Following infusion, thirst and copeptin (surrogate for vasopressin) were also higher in females than in males (21·3 (sd 2·0),","['Forty-nine adults (55 % female, age 39 (sd 8) years', 'Cellular dehydration acutely degrades mood mainly in women']",['hypertonic saline (HYPER) infusion or 0·9 % isotonic saline (ISO'],"['ISO', 'POMS sub-scale (confusion-bewilderment, depression-dejection, fatigue-inertia', 'Intracellular dehydration', 'Profile of Mood States Questionnaire (POMS', 'Total mood disturbance score (TMD) assessed by POMS', 'Plasma osmolality']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0007634', 'cui_str': 'Cell structure'}, {'cui': 'C0011175', 'cui_str': 'Dehydration'}, {'cui': 'C0026516', 'cui_str': 'Mood'}]","[{'cui': 'C0036085', 'cui_str': 'sodium chloride, hypertonic'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0454287', 'cui_str': 'Isotonic exercise'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0454287', 'cui_str': 'Isotonic exercise'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0451394', 'cui_str': 'Profile of mood states'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0009676', 'cui_str': 'Confusional state'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0175996', 'cui_str': 'Protoplasm'}, {'cui': 'C0011175', 'cui_str': 'Dehydration'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C2939186', 'cui_str': 'Disturbance in mood'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0860721', 'cui_str': 'Plasma osmolality'}]",49.0,0.109317,"Following infusion, thirst and copeptin (surrogate for vasopressin) were also higher in females than in males (21·3 (sd 2·0),","[{'ForeName': 'HyunGyu', 'Initials': 'H', 'LastName': 'Suh', 'Affiliation': 'Arizona State University, College of Health Solutions, Hydration Science Lab, Phoenix, AZ85004, USA.'}, {'ForeName': 'Harris R', 'Initials': 'HR', 'LastName': 'Lieberman', 'Affiliation': 'Newton, MA, USA.'}, {'ForeName': 'Lisa T', 'Initials': 'LT', 'LastName': 'Jansen', 'Affiliation': 'Division of Endocrinology, New Balance Foundation Obesity Prevention Center, Boston, MA02215, USA.'}, {'ForeName': 'Abigail T', 'Initials': 'AT', 'LastName': 'Colburn', 'Affiliation': 'Arizona State University, College of Health Solutions, Hydration Science Lab, Phoenix, AZ85004, USA.'}, {'ForeName': 'J D', 'Initials': 'JD', 'LastName': 'Adams', 'Affiliation': 'Department of Health and Human Performance, College of Charleston, Charleston, SC29424, USA.'}, {'ForeName': 'Adam D', 'Initials': 'AD', 'LastName': 'Seal', 'Affiliation': 'Arizona State University, College of Health Solutions, Hydration Science Lab, Phoenix, AZ85004, USA.'}, {'ForeName': 'Cory L', 'Initials': 'CL', 'LastName': 'Butts', 'Affiliation': 'Department of Exercise & Nutrition Sciences, Weber State University, Ogden, UT84408-2805, USA.'}, {'ForeName': 'Tracie M', 'Initials': 'TM', 'LastName': 'Kirkland', 'Affiliation': 'Department of Nursing, University of Southern California, Los Angeles, CA90033, USA.'}, {'ForeName': 'Olle', 'Initials': 'O', 'LastName': 'Melander', 'Affiliation': 'Division of Hypertension and Cardiovascular Disease, Lund University, 221 00 Malmø, Sweden.'}, {'ForeName': 'Tiphaine', 'Initials': 'T', 'LastName': 'Vanhaecke', 'Affiliation': 'Health, Hydration & Nutrition Science Department, Danone Research, 91120Palaiseau, France.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Dolci', 'Affiliation': 'Health, Hydration & Nutrition Science Department, Danone Research, 91120Palaiseau, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Lemetais', 'Affiliation': 'Health, Hydration & Nutrition Science Department, Danone Research, 91120Palaiseau, France.'}, {'ForeName': 'Erica T', 'Initials': 'ET', 'LastName': 'Perrier', 'Affiliation': 'Health, Hydration & Nutrition Science Department, Danone Research, 91120Palaiseau, France.'}, {'ForeName': 'Stavros A', 'Initials': 'SA', 'LastName': 'Kavouras', 'Affiliation': 'Arizona State University, College of Health Solutions, Hydration Science Lab, Phoenix, AZ85004, USA.'}]",The British journal of nutrition,['10.1017/S0007114520003475']
1495,33077119,Low caffeine dose improves intermittent sprint performance in hot and humid environments.,"While the effects of caffeine have been evaluated in relation to endurance exercise, few studies have assessed the ergogenic effects of low caffeine doses on intermittent exercise performance in hot and humid environments. Thus, we aimed to determine the effects of low-dose caffeine supplementation on intermittent exercise performance under these conditions. Eight male soccer players (age, 19.9 ± 0.3 years; height, 173.7 ± 6.3 cm; body mass, 65.1 ± 5.5 kg; V˙O 2 max, 50.0 ± 3.1 mL ⋅ kg -1 ⋅ min -1 ) participated in this double-blind, randomized, cross-over study. Caffeine was orally administered at 60 min before exercise (dosage, 3 mg ⋅ kg -1 ). The participants completed a 90-min intermittent sprint cycling protocol under two conditions (after receiving caffeine and placebo) at 32 °C and at 70% relative humidity. A significant improvement in the total amount of work was observed in the caffeine condition compared to the placebo condition (155.0 ± 15.8 vs 150.8 ± 14.5 kJ, respectively; p < 0.05, d = 0.28). In contrast, the rectal temperature measured at the end of exercise showed no significant difference between the conditions (38.9 ± 0.4 °C and 38.7 ± 0.5 °C in the caffeine and placebo conditions, respectively; p > 0.05, d = 0.57). Other thermal responses, such as the mean skin temperature, heart rate, or sweat volume, were not significantly different between these conditions. These results suggested that a low caffeine dose improved the intermittent sprint performance and the reasons could be explained by the fact that a low caffeine dose ingestion did not affect the thermoregulatory responses compared to the placebo condition and, thus, did not attenuate its ergogenic effect on exercise in hot and humid environments.",2020,"Other thermal responses, such as the mean skin temperature, heart rate, or sweat volume, were not significantly different between these conditions.","['Eight male soccer players (age, 19.9\xa0±\xa00.3 years; height, 173.7\xa0±\xa06.3\xa0cm; body mass, 65.1\xa0±\xa05.5\xa0kg; V˙O 2 max, 50.0\xa0±\xa03.1\xa0mL', 'hot and humid environments']","['caffeine', 'Caffeine', '90-min intermittent sprint cycling protocol under two conditions (after receiving caffeine and placebo', 'Low caffeine', 'caffeine supplementation']","['total amount of work', 'thermoregulatory responses', 'rectal temperature', 'mean skin temperature, heart rate, or sweat volume', 'intermittent sprint performance']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4068885', 'cui_str': '0.3'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C4319697', 'cui_str': '6.3'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C4517683', 'cui_str': '3.1'}, {'cui': 'C0444519', 'cui_str': 'Hot'}, {'cui': 'C0563027', 'cui_str': 'Humid environment'}]","[{'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0489749', 'cui_str': 'Rectal temperature'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037294', 'cui_str': 'Temperature of skin'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C1278296', 'cui_str': 'Sweat volume'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}]",8.0,0.200553,"Other thermal responses, such as the mean skin temperature, heart rate, or sweat volume, were not significantly different between these conditions.","[{'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Nakamura', 'Affiliation': 'Rikkyo research institute of Wellness, Rikkyo University, 3-34-1 Nishiikebukuro, Toshima-ku, 171-8501 Tokyo, Japan; Wheathernews Inc., Makuhari Techno Garden, Nakase 1-3 Mihama-ku, Chiba-shi, 261-0023, Chiba, Japan. Electronic address: daisuke.nakamura@ac.cyberhome.ne.jp.'}, {'ForeName': 'Yoko', 'Initials': 'Y', 'LastName': 'Tanabe', 'Affiliation': 'Faculty of Health and Sport Sciences at University of Tsukuba, 1-1-1 Tennodai, Tsukuba, 305-8577, Ibaraki, Japan.'}, {'ForeName': 'Takuma', 'Initials': 'T', 'LastName': 'Arimitsu', 'Affiliation': 'Faculty of Health Care, Department of Human Health Hachinohe Gakuin University, 13-98 Oazamihono, Hachinohe, 031-8588, Aomori, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Hasegawa', 'Affiliation': 'Graduate School of Integrated Arts and Sciences, Hiroshima University, Hiroshima, 1-7-1 Kagamiyama, Higashi-Hiroshima City, Hiroshima, 739-8521, Japan.'}, {'ForeName': 'Hideyuki', 'Initials': 'H', 'LastName': 'Takahashi', 'Affiliation': 'Department of Sports Research, Japan Institute of Sports Sciences (JISS), 3-15-1 Nishigaoka Kita-ku, Tokyo, 115-0056, Japan.'}]",Journal of thermal biology,['10.1016/j.jtherbio.2020.102698']
1496,33077128,Effects of exercise in hot and humid conditions and bovine colostrum on salivary immune markers.,"The purpose of this study was to examine the effects of exercise in a hot and humid environment on salivary lactoferrin and lysozyme. A secondary aim was to quantify the effects of 14-day bovine colostrum (BC) supplementation on salivary lactoferrin and lysozyme at rest and following exercise in hot and humid conditions. Using a randomized, double-blind, and counterbalanced design, ten males (20 ± 2 years, VO 2max  55.8 ± 3.7 mL kg -1  min -1 , 11.8 ± 2.7% body fat) ran for 46 ± 7.7 min at 95% of ventilatory threshold in a 40 °C and 50% RH environment after 14-days of supplementation with either BC or placebo. Saliva was collected pre, post, 1-h, and 4-h post exercise, and was analyzed for lactoferrin and lysozyme using ELISA. There was an immediate increase in the concentration and secretion rate of lactoferrin and lysozyme (p < 0.05) with exercise, but BC had no effect (p > 0.05). Saliva flow rate was not different between conditions [(PLA: pre: 0.54 ± 0.3, post: 0.44 ± 0.3, 1-h: 0.67 ± 0.3, 4-h: 1.0 ± 0.4 mL min -1 ); (BC: pre: 0.58 ± 0.2, post: 0.37 ± 0.1, 1-h: 0.63 ± 0.2, 4-h: 0.83 ± 0.4 mL min -1 )]. There were no differences in thermoregulatory markers (core temperature or physiological strain index) between BC and placebo trials. Interestingly, exercise-induced heat stress did not impair mucosal immune parameters, instead participants showed a transient increase in salivary lactoferrin and lysozyme. Further, 14-day BC supplementation had no effect on mucosal immunity at any time point.",2020,"There was an immediate increase in the concentration and secretion rate of lactoferrin and lysozyme (p < 0.05) with exercise, but BC had no effect (p > 0.05).","['hot and humid conditions', 'ten males (20\xa0±\xa02 years, VO 2max', '55.8\xa0±\xa03.7']","['14-day BC supplementation', 'placebo', '14-day bovine colostrum (BC) supplementation']","['thermoregulatory markers (core temperature or physiological strain index', 'mucosal immunity', 'Saliva flow rate', 'concentration and secretion rate of lactoferrin and lysozyme', 'salivary immune markers', 'salivary lactoferrin and lysozyme']","[{'cui': 'C0444519', 'cui_str': 'Hot'}, {'cui': 'C0205381', 'cui_str': 'Wet'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517696', 'cui_str': '3.7'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'C0009413', 'cui_str': 'Colostrum'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0282558', 'cui_str': 'Mucosal Immunity'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0022942', 'cui_str': 'Lactoferrin'}, {'cui': 'C0026794', 'cui_str': 'Muramidase'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0162489', 'cui_str': 'Immunologic Marker'}]",,0.431405,"There was an immediate increase in the concentration and secretion rate of lactoferrin and lysozyme (p < 0.05) with exercise, but BC had no effect (p > 0.05).","[{'ForeName': 'Zachary', 'Initials': 'Z', 'LastName': 'McKenna', 'Affiliation': 'University of New Mexico, Department of Health, Exercise, and Sports Sciences, Albuquerque, NM, USA. Electronic address: zmckenna@unm.edu.'}, {'ForeName': 'Quint', 'Initials': 'Q', 'LastName': 'Berkemeier', 'Affiliation': 'University of New Mexico, Department of Health, Exercise, and Sports Sciences, Albuquerque, NM, USA.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Gorini', 'Affiliation': 'California Baptist University, Department of Kinesiology, Riverside, CA, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Kuennen', 'Affiliation': 'High Point University, Department of Exercise Science, High Point, NC, USA.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Naylor', 'Affiliation': 'California Baptist University, Department of Kinesiology, Riverside, CA, USA.'}, {'ForeName': 'Austin', 'Initials': 'A', 'LastName': 'Kleint', 'Affiliation': 'Western University of Health Sciences, College of Osteopathic Medicine, Lebanon, OR, USA.'}, {'ForeName': 'Trevor', 'Initials': 'T', 'LastName': 'Gillum', 'Affiliation': 'California Baptist University, Department of Kinesiology, Riverside, CA, USA.'}]",Journal of thermal biology,['10.1016/j.jtherbio.2020.102717']
1497,33077136,"Concurrent adaptations in maximal aerobic capacity, heat tolerance, microvascular blood flow and oxygen extraction following heat acclimation and ischemic preconditioning.","We investigated the effects of: 1) Ischemic pre-conditioning (IPC) plus a concurrent five-day heat acclimation + IPC (IPC + HA), 2) five-day HA with sham IPC (HA), or 3) control (CON) on thermoneutral measurements of endurance performance, resting measures of skeletal muscle oxygenation and blood flow. Twenty-nine participants were randomly allocated to three groups, which included: 1) five-days of repeated leg occlusion (4 x 5-min) IPC at limb occlusive pressure, plus fixed-intensity (55% V˙ O 2max ) cycling HA at ~36 °C/40% humidity; 2) HA plus sham IPC (20 mmHg) or 3) or CON (thermoneutral 55% V˙ O 2max  plus sham IPC). In IPC + HA and HA, there were increases in maximal oxygen consumption (O 2max ) (7.8% and 5.4%, respectively; P < 0.05), ventilatory threshold (V T ) (5.6% and 2.4%, respectively, P < 0.05), delta efficiency (DE) (2.0% and 1.4%, respectively; P < 0.05) and maximum oxygen pulse (O 2 pulse-Max) (7.0% and 6.9%, respectively; P < 0.05) during an exhaustive incremental test. There were no changes for CON (P > 0.05). Changes (P < 0.05) in resting core temperature (T C ), muscle oxygen consumption (m V˙ O 2 ), and limb blood flow (LBF) were also found pre-to-post intervention among the HA and IPC + HA groups, but not in CON (P > 0.05). Five-days of either HA or IPC + HA can enhance markers of endurance performance in cooler environments, alongside improved muscle oxygen extraction, blood flow, exercising muscle efficiency and O 2  pulse at higher intensities, thus suggesting the occurrence of peripheral adaptation. Both HA and IPC + HA enhance the adaptation of endurance capacity, which might partly relate to peripheral changes.",2020,"Changes (P < 0.05) in resting core temperature (T C ), muscle oxygen consumption (m V˙","['36', 'Twenty-nine participants']","['O 2max  plus sham IPC', 'sham IPC (HA), or 3) control (CON', 'repeated leg occlusion (4 x 5-min) IPC at limb occlusive pressure, plus fixed-intensity (55% V˙', 'HA or IPC\xa0', '1) Ischemic pre-conditioning (IPC) plus a concurrent five-day heat acclimation\xa0+\xa0IPC (IPC\xa0+\xa0HA), 2', 'CON']","['ventilatory threshold', 'maximal oxygen consumption (O 2max ', 'muscle oxygen extraction, blood flow, exercising muscle efficiency', 'delta efficiency (DE', 'limb blood flow (LBF', 'maximum oxygen pulse', 'resting core temperature (T C ), muscle oxygen consumption (m V˙', 'CON', 'V˙', 'skeletal muscle oxygenation and blood flow', 'maximal aerobic capacity, heat tolerance, microvascular blood flow and oxygen extraction']","[{'cui': 'C0450351', 'cui_str': '29'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C1947917', 'cui_str': 'Occluded'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0376466', 'cui_str': 'Ischemic Pre-Conditioning'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}]","[{'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0439471', 'cui_str': 'lbf - pound-force'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C3544386', 'cui_str': 'Heat Tolerance'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}]",29.0,0.0694245,"Changes (P < 0.05) in resting core temperature (T C ), muscle oxygen consumption (m V˙","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Waldron', 'Affiliation': 'A-STEM Centre, College of Engineering, Swansea University, Swansea, UK; School of Science and Technology, University of New England, NSW, Australia; Welsh Institute of Performance Science, Swansea University, Swansea, UK. Electronic address: mark.waldron@swansea.ac.uk.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Papavasileiou', 'Affiliation': ""Sport, Health and Applied Sciences, St Mary's University, London, UK.""}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Jeffries', 'Affiliation': 'School of Biomedical, Nutritional and Sport Sciences, Newcastle University, Newcastle Upon Tyne, UK.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Nevola', 'Affiliation': 'A-STEM Centre, College of Engineering, Swansea University, Swansea, UK; Defence Science and Technology Laboratory (Dstl), Fareham, Hampshire, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Heffernan S', 'Affiliation': 'A-STEM Centre, College of Engineering, Swansea University, Swansea, UK.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Kilduff', 'Affiliation': 'A-STEM Centre, College of Engineering, Swansea University, Swansea, UK; Welsh Institute of Performance Science, Swansea University, Swansea, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Tallent', 'Affiliation': ""Sport, Health and Applied Sciences, St Mary's University, London, UK.""}]",Journal of thermal biology,['10.1016/j.jtherbio.2020.102724']
1498,33077240,Effect of needle diameter on pain during oocyte retrieval-a randomized controlled trial.,"OBJECTIVE


To study pain in women undergoing oocyte retrieval with a reduced needle (20/17 gauge) compared to a standard needle (16 gauge).
DESIGN


Single-center randomized controlled trial.
SETTING


Fertility clinic.
PATIENTS


Women undergoing their first oocyte retrieval for in vitro fertilization or intracytoplasmic sperm injection.
INTERVENTIONS


Oocyte retrieval with a reduced needle (20/17 gauge) or with a standard needle (16 gauge).
MAIN OUTCOME MEASURES


The primary outcome measure was intraoperative pain on an 11-point visual analogue scale (VAS). Secondary outcome measures included the following: dosage of fentanyl requested; pain at 5, 15 and 30 minutes after retrieval; and pain and analgesia until 4 days after retrieval.
RESULTS


A total of 47 women were randomized for the reduced needle (RN) and 48 for the standard needle (SN). Pain scores were significantly lower during and after retrieval with the RN. During retrieval, mean VAS scores in the RN group were 4.3 versus 6.3 in the SN group. Pain remained significantly lower in the RN group after retrieval, with VAS-scores of 1.2 vs. 2.1 directly after retrieval, 0.0 versus 2.0 5 minutes after retrieval, and 0.0 versus 1.0 30 minutes after retrieval. In the RN group, three patients (6.4%) requested more fentanyl during the procedure, versus 16 (33.3%) in the SN group. A total of 79 patients submitted their follow-up questionnaire (response rate 83%). Pain on the first 2 days following retrieval was significantly less in the RN group, with VAS scores of 1.6 versus 2.4 in the SN group, and 1.2 versus 2.5. In line with this finding, fewer patients in the RN group took analgesia on the days after the procedure. This difference was statistically significant only on day 3.
CONCLUSION


Use of a thinner needle results in significantly and clinically relevant lower pain scores during oocyte retrieval, and patients in the reduced needle group requested significantly less analgesia during oocyte retrieval than patients in the standard needle group. Pain scores remained significantly lower up until 2 days after the procedure.
DUTCH TRIAL REGISTRATION NUMBER


NTR6064 (www.trialregister.nl).",2020,"Pain on the first 2 days following retrieval was significantly less in the RN group, with VAS scores of 1.6 versus 2.4 in the SN group, and 1.2 versus 2.5.","['79 patients submitted their follow-up questionnaire (response rate 83', 'Women undergoing their first oocyte retrieval for in\xa0vitro fertilization or intracytoplasmic sperm injection', 'women undergoing oocyte retrieval with a reduced needle (20/17 gauge', 'A total of 47 women were randomized for the reduced needle (RN) and 48 for the standard needle (SN', 'Fertility clinic']","['standard needle (16 gauge', 'Oocyte retrieval with a reduced needle (20/17 gauge) or with a standard needle (16 gauge', 'needle diameter']","['dosage of fentanyl requested; pain at 5, 15 and 30 minutes after retrieval; and pain and analgesia until 4 days after retrieval', 'VAS scores', 'mean VAS scores', 'intraoperative pain on an 11-point visual analogue scale (VAS', 'Pain scores', 'analgesia', 'Pain', 'pain scores', 'pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0404268', 'cui_str': 'Oocyte recovery'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0455164', 'cui_str': 'IVF - In vitro fertilization with intracytoplasmic sperm injection (ICSI)'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0456564', 'cui_str': 'Gauges'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C4760630', 'cui_str': 'Infertility Clinics'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0456564', 'cui_str': 'Gauges'}, {'cui': 'C0404268', 'cui_str': 'Oocyte recovery'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}]","[{'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",47.0,0.116534,"Pain on the first 2 days following retrieval was significantly less in the RN group, with VAS scores of 1.6 versus 2.4 in the SN group, and 1.2 versus 2.5.","[{'ForeName': 'Erato Terpsichori', 'Initials': 'ET', 'LastName': 'Iduna Antigoni Buisman', 'Affiliation': ""Department of Obstetrics and Gynaecology, Jeroen Bosch Hospital, 's-Hertogenbosch, the Netherlands; Department of Obstetrics and Gynaecology, Radboud University Medical Centre, Nijmegen, the Netherlands. Electronic address: e.buisman@jbz.nl.""}, {'ForeName': 'Jan Peter', 'Initials': 'JP', 'LastName': 'de Bruin', 'Affiliation': ""Department of Obstetrics and Gynaecology, Jeroen Bosch Hospital, 's-Hertogenbosch, the Netherlands.""}, {'ForeName': 'Didi Dorothea', 'Initials': 'DD', 'LastName': 'Maria Braat', 'Affiliation': 'Department of Obstetrics and Gynaecology, Radboud University Medical Centre, Nijmegen, the Netherlands.'}, {'ForeName': 'Jan Willem', 'Initials': 'JW', 'LastName': 'van der Steeg', 'Affiliation': ""Department of Obstetrics and Gynaecology, Jeroen Bosch Hospital, 's-Hertogenbosch, the Netherlands.""}]",Fertility and sterility,['10.1016/j.fertnstert.2020.06.040']
1499,33077241,Time to pregnancy after a prepregnancy very-low-energy diet program in women with obesity: substudy of a randomized controlled trial.,"OBJECTIVE


To examine the impact of a prepregnancy very-low-energy diet (VLED) program on time to pregnancy in women with obesity.
DESIGN


Substudy of a two-arm parallel group randomized controlled trial.
SETTING


Multiple tertiary care centers.
PATIENT(S)


Women 18-38 years old with obesity (body mass index 30-55 kg/m 2 ) and planning conception.
INTERVENTION(S)


One hundred sixty-four normoglycemic women with body mass index 30-55 kg/m 2 , aged 18-38 years, and planning pregnancy were recruited through a social media platform for a two-arm randomized controlled trial. Women were allocated to a 12-week standard dietary intervention (SDI) or modified VLED. Completers of the intervention were observed for up to 48 weeks, and time to pregnancy was recorded.
MAIN OUTCOME MEASURE(S)


The prespecified exploratory outcome for this substudy was time to pregnancy between the completion of the 12-week intervention and the date of conception.
RESULT(S)


Maternal weight loss at the end of the 12-week intervention was 3.1% in the SDI group and 11.9% in the VLED group. In completers of the 12-week intervention, time to pregnancy was significantly shorter in the women allocated to the VLED group than in the SDI group. Post hoc analysis showed that this difference in time to conception was particularly overt within 90 days of the intervention.
CONCLUSION(S)


A VLED program that achieves substantial weight loss before conception reduces time to pregnancy compared with an SDI in women with obesity.
TRIAL REGISTRATION NUMBER


ACTRN12614001160628.",2020,"In completers of the 12-week intervention, time to pregnancy was significantly shorter in the women allocated to the VLED group than in the SDI group.","['Women 18-38 years old with obesity (body mass index 30-55 kg/m 2 ) and planning conception', 'One hundred sixty-four normoglycemic women with body mass index 30-55 kg/m 2 , aged 18-38 years, and planning pregnancy were recruited through a social media platform for a two-arm randomized controlled trial', 'Multiple tertiary care centers', 'women with obesity']","['prepregnancy very-low-energy diet program', 'prepregnancy very-low-energy diet (VLED) program', 'VLED', 'standard dietary intervention (SDI) or modified VLED']","['substantial weight loss', 'time to conception', 'Maternal weight loss', 'time to pregnancy']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0009637', 'cui_str': 'Conception'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0580545', 'cui_str': 'Blood glucose normal'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0032992', 'cui_str': 'Pregnant - planned'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}]","[{'cui': 'C0452268', 'cui_str': 'Very low energy diet'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0009637', 'cui_str': 'Conception'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C3494204', 'cui_str': 'Time-to-Pregnancy'}]",164.0,0.167214,"In completers of the 12-week intervention, time to pregnancy was significantly shorter in the women allocated to the VLED group than in the SDI group.","[{'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Price', 'Affiliation': ""Department of Medicine (Austin), University of Melbourne, Melbourne, Victoria, Australia; Department of Endocrinology, Austin Health, Melbourne, Victoria, Australia; Department of Diabetes and Endocrinology, Royal Melbourne Hospital, Melbourne, Victoria, Australia; Department of Obstetrics and Gynaecology, Mercy Hospital for Women, Melbourne, Victoria, Australia; Department of Obstetrics and Gynaecology, Royal Women's Hospital, Melbourne, Victoria, Australia. Electronic address: Sarah.price@unimelb.edu.au.""}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Sumithran', 'Affiliation': 'Department of Medicine (Austin), University of Melbourne, Melbourne, Victoria, Australia; Department of Endocrinology, Austin Health, Melbourne, Victoria, Australia.'}, {'ForeName': 'Luke A', 'Initials': 'LA', 'LastName': 'Prendergast', 'Affiliation': 'Department of Mathematics and Statistics, La Trobe University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Alison J', 'Initials': 'AJ', 'LastName': 'Nankervis', 'Affiliation': ""Department of Diabetes and Endocrinology, Royal Melbourne Hospital, Melbourne, Victoria, Australia; Department of Obstetrics and Gynaecology, Royal Women's Hospital, Melbourne, Victoria, Australia.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Permezel', 'Affiliation': 'Department of Obstetrics and Gynaecology, Mercy Hospital for Women, Melbourne, Victoria, Australia.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Proietto', 'Affiliation': 'Department of Medicine (Austin), University of Melbourne, Melbourne, Victoria, Australia; Department of Endocrinology, Austin Health, Melbourne, Victoria, Australia.'}]",Fertility and sterility,['10.1016/j.fertnstert.2020.06.033']
1500,33077258,"A phase II randomised, placebo-controlled trial of low dose (metronomic) cyclophosphamide and nintedanib (BIBF1120) in advanced ovarian, fallopian tube or primary peritoneal cancer.","BACKGROUND


We investigated the safety and efficacy of a combination of the oral tyrosine kinase inhibitor, nintedanib (BIBF 1120) with oral cyclophosphamide in patients with relapsed ovarian cancer.
PATIENTS AND METHODS


Patients with relapsed ovarian, fallopian tube or primary peritoneal cancer received oral cyclophosphamide (100 mg o.d.) and were randomised (1,1) to also have either oral nintedanib or placebo. The primary endpoint was overall survival (OS). Secondary endpoints included progression free survival (PFS), response rate, toxicity, and quality of life.
RESULTS


117 patients were randomised, 3 did not start trial treatment, median age 64 years. Forty-five (39%) had received ≥5 lines chemotherapy. 30% had received prior bevacizumab. The median OS was 6.8 (nintedanib) versus 6.4 (placebo) months (hazard ratio 1.08; 95% confidence interval 0.72-1.62; P = 0.72). The 6-month PFS rate was 29.6% versus 22.8% (P = 0.57). Grade 3/4 adverse events occurred in 64% (nintedanib) versus 54% (placebo) of patients (P = 0.28); the most frequent G3/4 toxicities were lymphopenia (18.6% nintedanib versus 16.4% placebo), diarrhoea (13.6% versus 0%), neutropenia (11.9% versus 0%), fatigue (10.2% versus 9.1%), and vomiting (10.2% versus 7.3%). Patients who had received prior bevacizumab treatment had 52 days less time on treatment (P < 0.01). 26 patients (23%) took oral cyclophosphamide for ≥6 months. There were no differences in quality of life between treatment arms.
CONCLUSIONS


This is the largest reported cohort of patients with relapsed ovarian cancer treated with oral cyclophosphamide. Nintedanib did not improve outcomes when added to oral cyclophosphamide. Although not significant, more patients than expected remained on treatment for ≥6 months. This may reflect a higher proportion of patients with more indolent disease or the higher dose of cyclophosphamide used.
CLINICAL TRIAL REGISTRATION


Clinicaltrials.govNCT01610869.",2020,The 6-month PFS rate was 29.6% versus 22.8% (P = 0.57).,"['Patients with relapsed ovarian, fallopian tube or primary peritoneal cancer received', 'patients with relapsed ovarian cancer treated with', 'advanced ovarian, fallopian tube or primary peritoneal cancer', 'patients with relapsed ovarian cancer', '117 patients were randomised, 3 did not start trial treatment, median age 64\xa0years', '26 patients (23%) took']","['oral cyclophosphamide', 'cyclophosphamide', 'low dose (metronomic) cyclophosphamide and nintedanib (BIBF1120', 'bevacizumab', '≥5 lines chemotherapy', 'placebo', 'oral nintedanib or placebo', 'oral cyclophosphamide ', 'oral tyrosine kinase inhibitor, nintedanib (BIBF 1120) with oral cyclophosphamide']","['6-month PFS rate', 'lymphopenia', 'overall survival (OS', 'Grade 3/4 adverse events', 'diarrhoea', 'progression free survival (PFS), response rate, toxicity, and quality of life', 'fatigue', 'median OS', 'neutropenia', 'vomiting', 'quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0015560', 'cui_str': 'Fallopian tube structure'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0153467', 'cui_str': 'Malignant tumor of peritoneum'}, {'cui': 'C0278689', 'cui_str': 'Recurrent ovarian cancer'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1515187', 'cui_str': 'Take'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C2930789', 'cui_str': 'nintedanib'}, {'cui': 'C1879771', 'cui_str': 'BIBF 1120'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1268567', 'cui_str': 'Protein-tyrosine kinase inhibitor'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0024312', 'cui_str': 'Lymphocytopenia'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}]",117.0,0.486171,The 6-month PFS rate was 29.6% versus 22.8% (P = 0.57).,"[{'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'Hall', 'Affiliation': 'Mount Vernon Cancer Centre, Northwood, UK. Electronic address: Marcia.hall@nhs.net.'}, {'ForeName': 'H-M', 'Initials': 'HM', 'LastName': 'Dehbi', 'Affiliation': 'Comprehensive Clinical Trials Unit at UCL, London, UK. Electronic address: h.dehbi@ucl.ac.uk.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Banerjee', 'Affiliation': 'Royal Marsden NHS Foundation Trust and Institute of Cancer Research, London, UK. Electronic address: Susana.banerjee@rmh.nhs.uk.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Lord', 'Affiliation': 'Clatterbridge Cancer Centre, Liverpool, UK. Electronic address: Rosemary.lord@clatterbridgecc.nhs.uk.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Clamp', 'Affiliation': 'The Christie NHS Foundation Trust and University of Manchester, UK. Electronic address: Andrew.clamp@christie.nhs.uk.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Ledermann', 'Affiliation': 'Cancer Research UK & UCL Cancer Trials Centre, London, UK. Electronic address: j.ledermann@ucl.ac.uk.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Nicum', 'Affiliation': 'Churchill Hospital, Oxford, UK. Electronic address: snicum@nhs.net.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Lilleywhite', 'Affiliation': 'Cancer Research UK & UCL Cancer Trials Centre, London, UK. Electronic address: r.e.lillywhite@bham.ac.uk.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Bowen', 'Affiliation': 'Royal United Hospital, Bath, UK. Electronic address: Rebecca.bowen3@nhs.net.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Michael', 'Affiliation': 'Royal Surrey County Hospital, Guildford, UK. Electronic address: a.michael@surrey.ac.uk.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Feeney', 'Affiliation': 'Cancer Research UK & UCL Cancer Trials Centre, London, UK. Electronic address: a.feeney@ucl.ac.uk.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Glasspool', 'Affiliation': 'Beatson Institute, Glasgow, UK. Electronic address: ros.glasspool@ggc.scot.nhs.uk.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Hackshaw', 'Affiliation': 'Cancer Research UK & UCL Cancer Trials Centre, London, UK. Electronic address: a.hackshaw@ucl.ac.uk.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Rustin', 'Affiliation': 'Mount Vernon Cancer Centre, Northwood, UK. Electronic address: grustin@nhs.net.'}]",Gynecologic oncology,['10.1016/j.ygyno.2020.09.048']
1501,33077270,"Response to the letter: Comment on ""simo decoction versus domperidone suspension for post-pyloric spiral nasoenteric tube placement: A multicenter, randomized, non-inferiority trial"".",,2020,,['post-pyloric spiral nasoenteric tube placement'],"['simo decoction', 'domperidone suspension']",[],"[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0034196', 'cui_str': 'Pyloric structure of stomach'}, {'cui': 'C0522554', 'cui_str': 'Spiral shape'}, {'cui': 'C1446323', 'cui_str': 'Nasoenteric tube'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C2718122', 'cui_str': 'simo'}, {'cui': 'C0013015', 'cui_str': 'Domperidone'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}]",[],,0.0696699,,"[{'ForeName': 'Zhimei', 'Initials': 'Z', 'LastName': 'He', 'Affiliation': ""Department of Critical Care Medicine, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, 106 Zhongshan Er Road, Guangzhou, 510080, Guangdong, China. Electronic address: 1315178805@qq.com.""}, {'ForeName': 'Linhui', 'Initials': 'L', 'LastName': 'Hu', 'Affiliation': ""Department of Critical Care Medicine, Clinical Research Center, Maoming People's Hospital, 101 Weimin Road, Maoming, 525000, Guangdong, China. Electronic address: hulinhui@live.cn.""}, {'ForeName': 'Chunbo', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': ""Department of Intensive Care Unit of Cardiovascular Surgery, Guangdong Cardiovascular Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, 96 Dongchuan Road, Guangzhou, 510080, Guangdong, China. Electronic address: gghccm@163.com.""}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2020.09.055']
1502,33077275,"Increased bioavailability of phenolic acids and enhanced vascular function following intake of feruloyl esterase-processed high fibre bread: A randomized, controlled, single blind, crossover human intervention trial.","BACKGROUND & AIMS


Clinical trial data have indicated an association between wholegrain consumption and a reduction in surrogate markers of cardiovascular disease. Phenolics present in wholegrain bound to arabinoxylan fibre may contribute these effects, particularly when released enzymatically from the fiber prior to ingestion. The aim of the present study was therefore to determine whether the intake of high fibre bread containing higher free ferulic acid (FA) levels (enzymatically released during processing) enhances human endothelium-dependent vascular function.
METHODS


A randomized, single masked, controlled, crossover, human intervention study was conducted on 19 healthy men. Individuals consumed either a high fibre flatbread with enzymatically released free FA (14.22 mg), an equivalent standard high fibre bread (2.34 mg), or a white bread control (0.48 mg) and markers of vascular function and plasma phenolic acid concentrations were measured at baseline, 2, 5 and 7 h post consumption.
RESULTS


Significantly increased brachial arterial dilation was observed following consumption of the high free FA ('enzyme-treated') high fibre bread verses both a white bread (2 h: p < 0.05; 5 h: p < 0.01) and a standard high fibre bread (5 h: p < 0.05). Concurrently, significant increases in plasma FA levels were observed, at 2 h (p < 0.01) after consumption of the enzyme-treated bread, relative to control treatments. Blood pressure, heart rate, DVP-SI and DVP-RI were not significantly altered following intake of any of the breads (p > 0.05).
CONCLUSION


Dietary intake of bread, processed enzymatically to release FA from arabinoxylan fiber during production increases the bioavailability of FA, and induces acute endothelium-dependent vasodilation.
CLINICAL TRIAL REGISTRY


NO: NCT03946293. WEBSITE: www.clinicaltrials.gov.",2020,"Concurrently, significant increases in plasma FA levels were observed, at 2 h (p < 0.01) after consumption of the enzyme-treated bread, relative to control treatments.",['19 healthy men'],['feruloyl esterase-processed high fibre bread'],"['Blood pressure, heart rate, DVP-SI and DVP-RI', 'bioavailability of phenolic acids and enhanced vascular function', 'free ferulic acid (FA) levels', 'vascular function and plasma phenolic acid concentrations', 'bioavailability of FA', 'brachial arterial dilation', 'plasma FA levels']","[{'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0117605', 'cui_str': 'feruloyl esterase'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C0006138', 'cui_str': 'Bread'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0078144', 'cui_str': 'VDP protocol'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C2586298', 'cui_str': 'Hydroxybenzoic acid'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0060291', 'cui_str': 'ferulic acid'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0445456', 'cui_str': 'Brachial'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}]",19.0,0.147132,"Concurrently, significant increases in plasma FA levels were observed, at 2 h (p < 0.01) after consumption of the enzyme-treated bread, relative to control treatments.","[{'ForeName': 'Alice L', 'Initials': 'AL', 'LastName': 'Turner', 'Affiliation': 'Department of Food and Nutritional Sciences, School of Chemistry, Food and Pharmacy, University of Reading, Reading, UK (ALT, JPES).'}, {'ForeName': 'Louise V', 'Initials': 'LV', 'LastName': 'Michaelson', 'Affiliation': 'Department of Plant Sciences, Rothamsted Research, Harpenden, UK (LVM, PRS, AL).'}, {'ForeName': 'Peter R', 'Initials': 'PR', 'LastName': 'Shewry', 'Affiliation': 'Department of Plant Sciences, Rothamsted Research, Harpenden, UK (LVM, PRS, AL).; School of Agriculture, Policy and Development, University of Reading, Reading, Berks, UK (PRS).'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Lovegrove', 'Affiliation': 'Department of Plant Sciences, Rothamsted Research, Harpenden, UK (LVM, PRS, AL).'}, {'ForeName': 'Jeremy P E', 'Initials': 'JPE', 'LastName': 'Spencer', 'Affiliation': 'Department of Food and Nutritional Sciences, School of Chemistry, Food and Pharmacy, University of Reading, Reading, UK (ALT, JPES).. Electronic address: j.p.e.spencer@reading.ac.uk.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2020.07.026']
1503,33077284,"Effect of oat β-glucan of different molecular weights on fecal bile acids, urine metabolites and pressure in the digestive tract - A human cross over trial.","While the development of oat products often requires altered molecular weight (MW) of β-glucan, the resulting health implications are currently unclear. This 3-leg crossover trial (n = 14) investigated the effects of the consumption of oat bran with High, Medium and Low MW β-glucan (average > 1000, 524 and 82 kDa respectively) with 3 consequent meals on oat-derived phenolic compounds in urine (UHPLC-MS/MS), bile acids in feces (UHPLC-QTOF), gastrointestinal conditions (ingestible capsule), and perceived gut well-being. Urine excretion of ferulic acid was higher (p < 0.001, p < 0.001), and the fecal excretion of deoxycholic (p < 0.03, p < 0.02) and chenodeoxycholic (p < 0.06, p < 0.02) acids lower after consumption of Low MW β-glucan compared with both Medium and High MW β-glucan. Duodenal pressure was higher after consumption of High MW β-glucan compared to Medium (p < 0.041) and Low (p < 0.022) MW β-glucan. The MW of β-glucan did not affect gut well-being, but the perceptions between females and males differed.",2020,Duodenal pressure was higher after consumption of High MW β-glucan compared to Medium (p < 0.041) and Low (p < 0.022),[],"['chenodeoxycholic', 'consumption of oat bran with High, Medium and Low MW β-glucan (average\xa0>\xa01000, 524 and 82\xa0kDa respectively) with 3 consequent meals on oat-derived phenolic compounds in', 'oat β-glucan']","['fecal excretion of deoxycholic', 'urine (UHPLC-MS/MS), bile acids in feces (UHPLC-QTOF), gastrointestinal conditions (ingestible capsule), and perceived gut well-being', 'Duodenal pressure', 'fecal bile acids, urine metabolites and pressure', 'Urine excretion of ferulic acid']",[],"[{'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0795649', 'cui_str': 'OAT BRAN'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0026385', 'cui_str': 'Molecular Weight'}, {'cui': 'C0017692', 'cui_str': 'Glucan (BO)'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C1532717', 'cui_str': 'kDa'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0028753', 'cui_str': 'Oats'}, {'cui': 'C0359916', 'cui_str': 'Substance with phenol structure'}, {'cui': 'C0205198', 'cui_str': 'Compound'}]","[{'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0599748', 'cui_str': 'Mass Spectrometry-Mass Spectrometry'}, {'cui': 'C0005390', 'cui_str': 'Bile acid'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013303', 'cui_str': 'Duodenal'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0060291', 'cui_str': 'ferulic acid'}]",,0.0567573,Duodenal pressure was higher after consumption of High MW β-glucan compared to Medium (p < 0.041) and Low (p < 0.022),"[{'ForeName': 'Salla', 'Initials': 'S', 'LastName': 'Hakkola', 'Affiliation': 'Food Chemistry and Food Development, Department of Biochemistry, University of Turku, Turku, Finland.'}, {'ForeName': 'Lotta', 'Initials': 'L', 'LastName': 'Nylund', 'Affiliation': 'Food Chemistry and Food Development, Department of Biochemistry, University of Turku, Turku, Finland.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Rosa-Sibakov', 'Affiliation': 'VTT Technical Research Centre of Finland Ltd, Espoo, Finland.'}, {'ForeName': 'Baoru', 'Initials': 'B', 'LastName': 'Yang', 'Affiliation': 'Food Chemistry and Food Development, Department of Biochemistry, University of Turku, Turku, Finland.'}, {'ForeName': 'Emilia', 'Initials': 'E', 'LastName': 'Nordlund', 'Affiliation': 'VTT Technical Research Centre of Finland Ltd, Espoo, Finland.'}, {'ForeName': 'Tapio', 'Initials': 'T', 'LastName': 'Pahikkala', 'Affiliation': 'Department of Future Technologies, University of Turku, Turku, Finland.'}, {'ForeName': 'Marko', 'Initials': 'M', 'LastName': 'Kalliomäki', 'Affiliation': 'Department of Pediatrics, University of Turku, Turku, Finland; Department of Pediatrics and Adolescent Medicine, Turku University Hospital, Turku, Finland.'}, {'ForeName': 'Anna-Marja', 'Initials': 'AM', 'LastName': 'Aura', 'Affiliation': 'VTT Technical Research Centre of Finland Ltd, Espoo, Finland.'}, {'ForeName': 'Kaisa M', 'Initials': 'KM', 'LastName': 'Linderborg', 'Affiliation': 'Food Chemistry and Food Development, Department of Biochemistry, University of Turku, Turku, Finland. Electronic address: kaisa.linderborg@utu.fi.'}]",Food chemistry,['10.1016/j.foodchem.2020.128219']
1504,33077301,"Concomitant administration of a liquid formulation of human rotavirus vaccine (porcine circovirus-free) with routine childhood vaccines in infants in the United States: Results from a phase 3, randomized trial.","BACKGROUND


In response to the detection of porcine circovirus type 1 (PCV-1) in the human rotavirus vaccine (HRV), a PCV-free HRV (no detection of PCV-1 and PCV-2 according to the detection limit of tests used) was developed. Liquid (Liq) PCV-free HRV previously showed immunogenicity and safety profiles comparable to lyophilized (Lyo) HRV.
METHODS


This was a phase 3a, randomized, single-blind study (NCT03207750) conducted in the United States. Healthy infants aged 6-12 weeks received 2 doses (0, 2 months) of either Liq PCV-free HRV or Lyo HRV with routine vaccines (0, 2, 4 months): diphtheria-tetanus-acellular pertussis, hepatitis B and inactivated poliovirus combination vaccine (DTaP-HBV-IPV), monovalent tetanus toxoid-conjugated vaccine against Haemophilus influenzae type b (Hib-TT), and 13-valent pneumococcal conjugate vaccine. Co-primary objectives were: (i) to assess non-inferiority of immune responses to routine vaccine antigens 1 month post-dose 3 following co-administration with Liq PCV-free HRV compared to Lyo HRV; (ii) to rule out a 10% decrease in seroresponse to pertussis antigens after dose 3. Other objectives were to evaluate immunogenicity and safety of HRV vaccines.
RESULTS


Of 1272 vaccinated infants, 990 (489 in Liq PCV-free HRV and 501 in Lyo HRV group) were included in the per-protocol set. All statistical criteria were met, thus co-primary objectives were demonstrated. Seroprotection/seropositivity rates in both groups were high: 100% for diphtheria/tetanus, ≥99.3% for HBV, ≥99.8% for polio, ≥99.8% for each pertussis antigen, ≥90.8% for all pneumococcal serotypes except serotype 3 (≥69.1%), and ≥ 97.4% for Hib. Most infants seroconverted for anti-RV antibodies (76.3% of Liq PCV-free HRV and 78.9% of Lyo HRV recipients). Geometric mean concentrations/titers were comparable between groups. Incidences of adverse events and serious adverse events were similar between groups.
CONCLUSION


Routine pediatric vaccines co-administered with Liq PCV-free HRV showed non-inferior immune responses and similar safety profiles to those following co-administration with Lyo HRV.",2020,"Seroprotection/seropositivity rates in both groups were high: 100% for diphtheria/tetanus, ≥99.3% for HBV, ≥99.8% for polio, ≥99.8% for each pertussis antigen, ≥90.8% for all pneumococcal serotypes except serotype 3 (≥69.1%), and ≥ 97.4% for Hib.","['Healthy infants aged 6-12\xa0weeks', 'infants in the United States', '1272 vaccinated infants']","['Liq PCV-free HRV or Lyo HRV with routine vaccines (0, 2, 4\xa0months): diphtheria-tetanus-acellular pertussis, hepatitis B and inactivated poliovirus combination vaccine (DTaP-HBV-IPV), monovalent tetanus toxoid-conjugated vaccine against Haemophilus influenzae type b (Hib-TT), and 13-valent pneumococcal conjugate vaccine', 'liquid formulation of human rotavirus vaccine (porcine circovirus-free) with routine childhood vaccines', 'Routine pediatric vaccines co-administered with Liq PCV-free HRV', 'routine vaccine antigens 1\xa0month post-dose 3 following co-administration with Liq PCV-free HRV compared to Lyo HRV']","['Incidences of adverse events and serious adverse events', 'Geometric mean concentrations/titers', 'Seroprotection/seropositivity rates']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0318711', 'cui_str': 'Human rotavirus'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0012546', 'cui_str': 'Diphtheria'}, {'cui': 'C0039614', 'cui_str': 'Tetanus'}, {'cui': 'C0982332', 'cui_str': 'acellular pertussis vaccine, inactivated'}, {'cui': 'C0019163', 'cui_str': 'Type B viral hepatitis'}, {'cui': 'C0206435', 'cui_str': 'Human poliovirus'}, {'cui': 'C0206253', 'cui_str': 'Vaccines, Combination'}, {'cui': 'C0909900', 'cui_str': 'diphtheria-tetanus-acellular pertussis-Hib-hepatitis B vaccine'}, {'cui': 'C0718003', 'cui_str': 'Inactivated Poliovirus vaccine'}, {'cui': 'C0039620', 'cui_str': 'Tetanus vaccine'}, {'cui': 'C0206515', 'cui_str': 'Vaccines, Conjugate'}, {'cui': 'C0121772', 'cui_str': 'Haemophilus influenzae type b'}, {'cui': 'C0062082', 'cui_str': 'Haemophilus influenza type b polysaccharide vaccine-tetanus toxin conjugate'}, {'cui': 'C3152625', 'cui_str': 'Pneumococcal 13-valent conjugate vaccine'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0206411', 'cui_str': 'Porcine circovirus'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0003320', 'cui_str': 'Antigen'}, {'cui': 'C0439568', 'cui_str': 'Post-dose'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0475208', 'cui_str': 'Titer'}]",1272.0,0.0735363,"Seroprotection/seropositivity rates in both groups were high: 100% for diphtheria/tetanus, ≥99.3% for HBV, ≥99.8% for polio, ≥99.8% for each pertussis antigen, ≥90.8% for all pneumococcal serotypes except serotype 3 (≥69.1%), and ≥ 97.4% for Hib.","[{'ForeName': 'Remon', 'Initials': 'R', 'LastName': 'Abu-Elyazeed', 'Affiliation': 'Acevedo Clinical Research Associates, Miami 33142, Florida, United States. Electronic address: remon.abu-elyazeed@gsk.com.'}, {'ForeName': 'Nicola P', 'Initials': 'NP', 'LastName': 'Klein', 'Affiliation': 'PriMed Clinical Research, Dayton 45419, Ohio, United States. Electronic address: nicola.klein@kp.org.'}, {'ForeName': 'Leentje', 'Initials': 'L', 'LastName': 'Moerman', 'Affiliation': ""Midwest Children's Health Research Institute, Lincoln 68522, Nebraska, United States. Electronic address: leentje.f.moerman@gsk.com.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Povey', 'Affiliation': ""Midwest Children's Health Research Institute, Lincoln 68522, Nebraska, United States. Electronic address: michael.x.povey@gsk.com.""}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Pruitt', 'Affiliation': 'Gentle Medicine Associates, Boynton Beach 33435, Florida, United States. Electronic address: pruitt@rx-research.com.'}, {'ForeName': 'Shelly', 'Initials': 'S', 'LastName': 'Senders', 'Affiliation': 'The Pediatric Center of Frederick LLC, Frederick 21702, Maryland, United States. Electronic address: ssenders@senderspediatrics.com.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Silas', 'Affiliation': 'Utah Valley Pediatrics - Timpanogos, Orem 84057, Utah, United States. Electronic address: silas@rx-research.com.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Bi', 'Affiliation': ""Midwest Children's Health Research Institute, Lincoln 68522, Nebraska, United States. Electronic address: dan.x.bi@gsk.com.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Vaccine,['10.1016/j.vaccine.2020.08.070']
1505,33077341,Ropeginterferon Alfa-2b administered every two weeks for patients with genotype 2 chronic hepatitis C.,"BACKGROUND


Ropeginterferon alfa-2b is a novel mono-pegylated interferon that has only one major form as opposed to the 8 to 14 isomers of other on-market pegylated interferon products, allowing every-two-week injection with high tolerability. It received European Medicines Agency marketing authorization in 2019 and Taiwan Biologics License Applications Approval in 2020 for the treatment of polycythemia vera. This study aimed to evaluate the safety and efficacy of Ropeginterferon alfa-2b plus ribavirin in genotype 2 chronic hepatitis C (CHC) patients.
METHODS


Eighty-six treatment naive patients with genotype 2 CHC were randomized to weekly peginterferon alfa-2a (Peg-IFN-α2a) at 180 μg (n = 22), or every-two-week Ropeginterferon alfa-2b at 270 μg (n = 23), 360 μg (n = 21), 450 μg (n = 20), plus daily oral ribavirin 1000 mg (≤75 kg) or 1200 mg (>75 kg). Patients with rapid virologic response received 16-week regimen while those without RVR received 24-week regimen. The primary endpoint was sustained virologic response at 24 weeks post-treatment (SVR24).
RESULTS


SVR24 was achieved by 95.5%, 78.3%, 85.7%, and 60% of subjects in Peg-IFN-α2a 180 μg, Ropeginterferon alfa-2b 270 μg, 360 μg, and 450 μg groups, respectively. The safety profile was similar across 4 groups. The incidence rate of adverse event during the treatment period was 0.407, 0.252, 0.395, and 0.347 per patient-week, respectively.
CONCLUSION


Ropeginterferon alfa-2b, although at only half the number of injections, is as safe and effective as Peg-IFN-α2a for genotype 2 CHC. A phase 3 study to confirm safety and efficacy of Ropeginterferon alfa-2b in genotype 2 CHC is ongoing.",2020,"The incidence rate of adverse event during the treatment period was 0.407, 0.252, 0.395, and 0.347 per patient-week, respectively.
","['Eighty-six treatment naive patients with genotype 2 CHC', 'genotype 2 chronic hepatitis C (CHC) patients', 'patients with genotype 2 chronic hepatitis C', 'Patients with rapid virologic response']","['Ropeginterferon alfa-2b plus ribavirin', 'Ropeginterferon alfa-2b', 'plus daily oral ribavirin', 'peginterferon alfa-2a (Peg-IFN-α2a', 'Ropeginterferon Alfa-2b']","['sustained virologic response', 'safety profile', 'safety and efficacy', 'incidence rate of adverse event', 'SVR24']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C0524910', 'cui_str': 'Chronic hepatitis C'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0205466', 'cui_str': 'Virologic'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0035525', 'cui_str': 'Ribavirin'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0391001', 'cui_str': 'peginterferon alfa-2a'}, {'cui': 'C0032478', 'cui_str': 'Polyethylene Glycol 400'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}]","[{'cui': 'C4050171', 'cui_str': 'Sustained Viral Suppression'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",86.0,0.132366,"The incidence rate of adverse event during the treatment period was 0.407, 0.252, 0.395, and 0.347 per patient-week, respectively.
","[{'ForeName': 'Shih-Jer', 'Initials': 'SJ', 'LastName': 'Hsu', 'Affiliation': 'Department of Internal Medicine, National Taiwan University Hospital Yunlin Branch, Yunlin, Taiwan; Hepatology Medical Center, National Taiwan University Hospital Yunlin Branch, Yunlin, Taiwan. Electronic address: shihjer.hsu@gmail.com.'}, {'ForeName': 'Ming-Lung', 'Initials': 'ML', 'LastName': 'Yu', 'Affiliation': 'Hepatobiliary Division, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan; School of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan. Electronic address: fish6069@gmail.com.'}, {'ForeName': 'Chien-Wei', 'Initials': 'CW', 'LastName': 'Su', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Taipei Veterans General Hospital, Taipei, Taiwan. Electronic address: cwsu2@vghtpe.gov.tw.'}, {'ForeName': 'Cheng-Yuan', 'Initials': 'CY', 'LastName': 'Peng', 'Affiliation': 'Center for Digestive Medicine, Department of Internal Medicine, China Medical University Hospital, School of Medicine, China Medical University, Taichung, Taiwan. Electronic address: cypeng@mail.cmuh.org.tw.'}, {'ForeName': 'Rong-Nan', 'Initials': 'RN', 'LastName': 'Chien', 'Affiliation': 'Division of Hepatology, Department of Gastroenterology and Hepatology, Linkou Medical Center, Chang Gung Memorial Hospital, Taiwan. Electronic address: ronald@cgmh.org.tw.'}, {'ForeName': 'Hsien-Hong', 'Initials': 'HH', 'LastName': 'Lin', 'Affiliation': 'Division of Gastroenterology and Hepatology, Taipei Tzu Chi Hospital, Taipei, Taiwan. Electronic address: yoyo@tzuchi.com.tw.'}, {'ForeName': 'Gin-Ho', 'Initials': 'GH', 'LastName': 'Lo', 'Affiliation': 'Division of Gastroenterology, Department of Medical Research, E-DA Hospital, Kaohsiung, Taiwan. Electronic address: ed104676@edah.org.tw.'}, {'ForeName': 'Wei-Wen', 'Initials': 'WW', 'LastName': 'Su', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Changhua Christian Hospital, Changhua, Taiwan. Electronic address: 35301@cch.org.tw.'}, {'ForeName': 'Hsing-Tao', 'Initials': 'HT', 'LastName': 'Kuo', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Chi Mei Medical Center, Tainan, Taiwan. Electronic address: kuohsingtao@gmail.com.'}, {'ForeName': 'Chao-Wei', 'Initials': 'CW', 'LastName': 'Hsu', 'Affiliation': 'Division of Hepatology, Department of Gastroenterology and Hepatology, Linkou Medical Center, Chang Gung Memorial Hospital, Taiwan. Electronic address: hsu2406@cgmh.org.tw.'}, {'ForeName': 'Sien-Sing', 'Initials': 'SS', 'LastName': 'Yang', 'Affiliation': 'Liver Center, Cathay General Hospital Medical Center, Taipei, Taiwan. Electronic address: yangsien@hotmail.com.'}, {'ForeName': 'Sheng-Shun', 'Initials': 'SS', 'LastName': 'Yang', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, Taichung Veterans General Hospital, Taichung, Taiwan. Electronic address: yansh@vghtc.gov.tw.'}, {'ForeName': 'Kuan-Chiao', 'Initials': 'KC', 'LastName': 'Tseng', 'Affiliation': 'PharmaEssentia Corp., Taipei, Taiwan. Electronic address: joe.ktseng@gmail.com.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Qin', 'Affiliation': 'PharmaEssentia Corp., Taipei, Taiwan. Electronic address: albert_qin@pharmaessentia.com.'}, {'ForeName': 'Yi-Wen', 'Initials': 'YW', 'LastName': 'Huang', 'Affiliation': 'Liver Center, Cathay General Hospital Medical Center, Taipei, Taiwan; PharmaEssentia Corp., Taipei, Taiwan; School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan. Electronic address: yiwenhuang@ntu.edu.tw.'}, {'ForeName': 'Wan-Long', 'Initials': 'WL', 'LastName': 'Chuang', 'Affiliation': 'Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan. Electronic address: waloch@kmu.edu.tw.'}]",Journal of the Formosan Medical Association = Taiwan yi zhi,['10.1016/j.jfma.2020.09.018']
1506,33077355,The long-term costs and effects of tubal flushing with oil-based versus water-based contrast during hysterosalpingography.,"RESEARCH QUESTION


What are the long-term costs and effects of oil- versus water-based contrast in infertile women undergoing hysterosalpingography (HSG)?
DESIGN


This economic evaluation of a long-term follow-up of a multicentre randomized controlled trial involved 1119 infertile women randomized to HSG with oil- (n = 557) or water-based contrast (n = 562) in the Netherlands.
RESULTS


In the oil-based contrast group, 39.8% of women needed no other treatment, 34.6% underwent intrauterine insemination (IUI) and 25.6% had IVF/intracytoplasmic sperm injection (ICSI) in the 5 years following HSG. In the water-based contrast group, 35.0% of women had no other treatment, 34.2% had IUI and 30.8% had IVF/ICSI in the 5 years following HSG (P = 0.113). After 5 years of follow-up, HSG using oil-based contrast resulted in equivalent costs (mean cost difference -€144; 95% confidence interval [CI] -€579 to +€290; P = 0.515) for a 5% increase in the cumulative ongoing pregnancy rate compared with HSG using water-based contrast (80% compared with 75%, Relative Risk (RR) 1.07; 95% CI 1.00-1.14). Similarly, HSG with oil-based contrast resulted in equivalent costs (mean cost difference -€50; 95% CI -€576 to +€475; P = 0.850) for a 7.5% increase in the cumulative live birth rate compared with HSG with water-based contrast (74.8% compared with 67.3%, RR 1.11; 95% CI 1.03-1.20), making it the dominant strategy. Scenario analyses suggest that the oil-based contrast medium is the dominant strategy up to a price difference of €300.
CONCLUSION


Over a 5-year follow-up, HSG with an oil-based contrast was associated with a 5% increase in ongoing pregnancy rate, a 7.5% increase in live birth rate and similar costs to HSG with water-based contrast.",2020,"After 5 years of follow-up, HSG using oil-based contrast resulted in equivalent costs (mean cost difference -€144; 95% confidence interval [CI] -€579 to +€290; P = 0.515) for a 5% increase in the cumulative ongoing pregnancy rate compared with HSG using water-based contrast (80% compared with 75%, Relative Risk (RR) 1.07; 95% CI 1.00-1.14).","['1119 infertile women randomized to HSG with oil- (n\u202f=\u202f557) or water-based contrast (n\u202f=\u202f562) in the Netherlands', 'infertile women undergoing hysterosalpingography (HSG']",['tubal flushing with oil-based versus water-based contrast during hysterosalpingography'],"['cumulative live birth rate', 'ongoing pregnancy rate', 'IVF/ICSI', 'IVF/intracytoplasmic sperm injection (ICSI', 'cumulative ongoing pregnancy rate', 'equivalent costs', 'live birth rate']","[{'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0020709', 'cui_str': 'Hysterosalpingography'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}]","[{'cui': 'C4285925', 'cui_str': 'Tubal flushing'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0020709', 'cui_str': 'Hysterosalpingography'}]","[{'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0455164', 'cui_str': 'IVF - In vitro fertilization with intracytoplasmic sperm injection (ICSI)'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",1119.0,0.14394,"After 5 years of follow-up, HSG using oil-based contrast resulted in equivalent costs (mean cost difference -€144; 95% confidence interval [CI] -€579 to +€290; P = 0.515) for a 5% increase in the cumulative ongoing pregnancy rate compared with HSG using water-based contrast (80% compared with 75%, Relative Risk (RR) 1.07; 95% CI 1.00-1.14).","[{'ForeName': 'Nienke', 'Initials': 'N', 'LastName': 'van Welie', 'Affiliation': 'Department of Reproductive Medicine, Amsterdam UMC, Amsterdam Reproduction and Development Research Institute, Vrije Universiteit Amsterdam Amsterdam, the Netherlands. Electronic address: n.vanwelie@amsterdamumc.nl.'}, {'ForeName': 'Clarabelle T', 'Initials': 'CT', 'LastName': 'Pham', 'Affiliation': 'Flinders Health and Medical Research Institute, Flinders University, Adelaide, Australia.'}, {'ForeName': 'Joukje', 'Initials': 'J', 'LastName': 'van Rijswijk', 'Affiliation': 'Department of Reproductive Medicine, Amsterdam UMC, Amsterdam Reproduction and Development Research Institute, Vrije Universiteit Amsterdam Amsterdam, the Netherlands.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Dreyer', 'Affiliation': 'Department of Reproductive Medicine, Amsterdam UMC, Amsterdam Reproduction and Development Research Institute, Vrije Universiteit Amsterdam Amsterdam, the Netherlands.'}, {'ForeName': 'Harold R', 'Initials': 'HR', 'LastName': 'Verhoeve', 'Affiliation': 'Department of Obstetrics and Gynaecology, OLVG, Amsterdam, the Netherlands.'}, {'ForeName': 'Annemieke', 'Initials': 'A', 'LastName': 'Hoek', 'Affiliation': 'Department of Reproductive Medicine and Gynaecology, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Jan Peter', 'Initials': 'JP', 'LastName': 'de Bruin', 'Affiliation': ""Department of Obstetrics and Gynaecology, Jeroen Bosch Hospital, 's Hertogenbosch, the Netherlands.""}, {'ForeName': 'Annemiek W', 'Initials': 'AW', 'LastName': 'Nap', 'Affiliation': 'Department of Obstetrics and Gynaecology, Rijnstate Hospital, Arnhem, the Netherlands.'}, {'ForeName': 'Machiel H A', 'Initials': 'MHA', 'LastName': 'van Hooff', 'Affiliation': 'Department of Obstetrics and Gynaecology, Franciscus Hospital, Rotterdam, the Netherlands.'}, {'ForeName': 'Mariëtte', 'Initials': 'M', 'LastName': 'Goddijn', 'Affiliation': 'Centre for Reproductive Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Angelo B', 'Initials': 'AB', 'LastName': 'Hooker', 'Affiliation': 'Department of Obstetrics and Gynaecology, Zaans Medical Centre, Zaandam, the Netherlands.'}, {'ForeName': 'Anna P', 'Initials': 'AP', 'LastName': 'Gijsen', 'Affiliation': 'Department of Obstetrics and Gynaecology, Elkerliek Hospital, Helmond, the Netherlands.'}, {'ForeName': 'Maaike A F', 'Initials': 'MAF', 'LastName': 'Traas', 'Affiliation': 'Department of Obstetrics and Gynaecology, Gelre Hospitals, Apeldoorn, the Netherlands.'}, {'ForeName': 'Jesper M J', 'Initials': 'JMJ', 'LastName': 'Smeenk', 'Affiliation': 'Department of Obstetrics and Gynaecology, Elisabeth-TweeSteden Hospital, Tilburg, the Netherlands.'}, {'ForeName': 'Alexander V', 'Initials': 'AV', 'LastName': 'Sluijmer', 'Affiliation': 'Department of Obstetrics and Gynaecology, Wilhelmina Hospital, Assen, the Netherlands.'}, {'ForeName': 'Marieke J', 'Initials': 'MJ', 'LastName': 'Lambers', 'Affiliation': 'Department of Obstetrics and Gynaecology, Dijklander Hospital, Hoorn, the Netherlands.'}, {'ForeName': 'Gijsbertus A', 'Initials': 'GA', 'LastName': 'van Unnik', 'Affiliation': 'Department of Obstetrics and Gynaecology, Alrijne Hospital, Leiden, the Netherlands.'}, {'ForeName': 'Cornelia H', 'Initials': 'CH', 'LastName': 'de Koning', 'Affiliation': 'Department of Obstetrics and Gynaecology, Tergooi Hospital, Blaricum, the Netherlands.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Mozes', 'Affiliation': 'Department of Obstetrics and Gynaecology, Amstelland Hospital, Amstelveen, the Netherlands.'}, {'ForeName': 'Catharina C M', 'Initials': 'CCM', 'LastName': 'Timmerman', 'Affiliation': 'Department of Obstetrics and Gynaecology, Bravis Hospital, Roosendaal, the Netherlands.'}, {'ForeName': 'Cornelis B', 'Initials': 'CB', 'LastName': 'Lambalk', 'Affiliation': 'Department of Reproductive Medicine, Amsterdam UMC, Amsterdam Reproduction and Development Research Institute, Vrije Universiteit Amsterdam Amsterdam, the Netherlands.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Karnon', 'Affiliation': 'Flinders Health and Medical Research Institute, Flinders University, Adelaide, Australia.'}, {'ForeName': 'Velja', 'Initials': 'V', 'LastName': 'Mijatovic', 'Affiliation': 'Department of Reproductive Medicine, Amsterdam UMC, Amsterdam Reproduction and Development Research Institute, Vrije Universiteit Amsterdam Amsterdam, the Netherlands.'}, {'ForeName': 'Ben Willem J', 'Initials': 'BWJ', 'LastName': 'Mol', 'Affiliation': ""Department of Obstetrics and Gynaecology, Monash University, Clayton, Australia; Aberdeen Centre for Women's Health Research, University of Aberdeen, Aberdeen, United Kingdom.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Reproductive biomedicine online,['10.1016/j.rbmo.2020.09.015']
1507,33077437,"Ceftriaxone Plus Methylprednisolone Combination Therapy Versus Methylprednisolone Monotherapy in Patients With Acute Spinal Cord Injury: A Randomized, Triple-Blind Clinical Trial.","BACKGROUND


Guidelines do not suggest the routine use of methylprednisolone (MP) in patients with acute traumatic spinal cord injury (SCI). We tested the hypothesis regarding whether combination therapy with ceftriaxone and MP is superior to MP monotherapy in patients with acute traumatic SCI.
METHODS


In a randomized, triple-blind clinical trial, 60 patients with acute (first 8 hours of the injury) traumatic SCI were enrolled at the Tabriz University of Medical Sciences, Tabriz, Iran, between December 2016 and June 2017. Accordingly, the patients were randomly divided into 2 case and control groups (n = 30 each). Upon admission, all included patients received a bolus dose of MP at 33 mg/kg intravenously (IV) for 15 minutes. Then, after 45 minutes, MP infusion was continued for 24 to 48 hours at a 5.4 mg/kg IV dose. The case group received an additional dose of ceftriaxone at 1 g 2 times a day for 7 days through an IV route. Erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) were checked and compared between case and control groups upon admission and on the fourth and eighth days. Also, sensory and motor functions were evaluated according to the American Spinal Injury Association (ASIA) grading score upon admission, on the third and seventh days, upon discharge and 6 months after admission.
RESULTS


Analyses showed a significant statistical difference between groups in the changes in CRP levels during days 1 and 4 ( P  = .001) and also during days 4 and 8 ( P  = .001). However, no significant statistical difference was detected in ESR levels changes between groups during days 1 and 4 ( P  = .073), and during days 4 and 8 ( P  = .069). ASIA scale was found to be significantly different between the MP plus ceftriaxone group and MP monotherapy upon admission and 6 months after treatment ( P  = .001 for both comparisons). However, the number of variations in the ASIA score had no significant statistical difference between groups 6 months after intervention ( P  = .465).
CONCLUSION


The addition of ceftriaxone to the routine therapeutic protocol of acute SCI is accompanied by improved inflammation markers and functional outcomes 6 months after the intervention.",2020,ASIA scale was found to be significantly different between the MP plus ceftriaxone group and MP monotherapy upon admission and 6 months after treatment (,"['patients with acute traumatic SCI', 'patients with acute traumatic spinal cord injury (SCI', '60 patients with acute (first 8 hours of the injury) traumatic SCI were enrolled at the Tabriz University of Medical Sciences, Tabriz, Iran, between December 2016 and June 2017', 'Patients With Acute Spinal Cord Injury']","['methylprednisolone (MP', 'ceftriaxone', 'ceftriaxone and MP', 'Ceftriaxone Plus Methylprednisolone Combination Therapy Versus Methylprednisolone Monotherapy', 'MP monotherapy', 'MP']","['ASIA scale', 'CRP levels', 'ESR levels changes', 'sensory and motor functions', 'Erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C1292429', 'cui_str': '8 hours'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0007561', 'cui_str': 'Ceftriaxone'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}]","[{'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement'}, {'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}]",60.0,0.193406,ASIA scale was found to be significantly different between the MP plus ceftriaxone group and MP monotherapy upon admission and 6 months after treatment (,"[{'ForeName': 'Farhad', 'Initials': 'F', 'LastName': 'Mirzaei', 'Affiliation': 'Department of Neurosurgery, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Meshkini', 'Affiliation': 'Department of Neurosurgery, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Bohlool', 'Initials': 'B', 'LastName': 'Habibi', 'Affiliation': 'Department of Neurosurgery, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Firooz', 'Initials': 'F', 'LastName': 'Salehpour', 'Affiliation': 'Department of Neurosurgery, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Ebrahim', 'Initials': 'E', 'LastName': 'Rafei', 'Affiliation': 'Department of Neurosurgery, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Wouria', 'Initials': 'W', 'LastName': 'Fathi', 'Affiliation': 'Department of Neurosurgery, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Seyed Hamed Naseri', 'Initials': 'SHN', 'LastName': 'Alavi', 'Affiliation': 'Faculty of Medicine, Guilan University of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Majdi', 'Affiliation': 'Neuroscience Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Sepide', 'Initials': 'S', 'LastName': 'Rahigh-AghsaN', 'Affiliation': 'Department of Clinical Pharmacy, Faculty of Pharmacy, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Seyed Ahmad Naseri', 'Initials': 'SAN', 'LastName': 'Alavi', 'Affiliation': 'Department of Neurosurgery, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran.'}]",International journal of spine surgery,['10.14444/7102']
1508,33077559,Effectiveness of negative pressure wound therapy in the prevention of surgical wound complications in the cesarean section at-risk population: a parallel group randomised multicentre trial-the CYGNUS protocol.,"INTRODUCTION


Caesarean delivery is steadily becoming one of the more common surgical procedures in Australia with over 100 000 caesarean sections performed each year. Over the last 10 years in Australia, the caesarean section rate has increased from 28% in 2003 to 33% in 2013. On the international stage, the Australian caesarean delivery rates are higher than the average for the Organisation for Economic Co-operation and Development, Australia ranked as 8 out of 33 and is second to the USA. Postoperative surgical site infections (SSIs) and wound complications are the most common and costly event following a caesarean section. Globally, complication rates following a caesarean delivery vary from 4.9% to 9.8%. Complications such as infection and wound breakdown affect the postpartum mother's health and well-being, and contribute to healthcare costs for clinical management that often spans the acute, community and primary healthcare settings. Published level one studies using advanced wound dressings in the identified 'at-risk' population prior to surgery for prophylactic intervention are yet to be forthcoming.
METHODS AND ANALYSIS


A parallel group randomised control trial of 448 patients will be conducted across two metropolitan hospitals in Perth, Western Australia, which provide obstetric and midwifery services. We will recruit pregnant women in the last trimester, prior to their admission into the healthcare facility for delivery of their child. We will use a computer-generated block sequence to randomise the 448 participants to either the interventional (negative pressure wound therapy (NPWT) dressing, n=224) or comparator arm (non-NPWT dressing, n=224). The primary outcome measure is the occurrence of surgical wound dehiscence (SSWD) or SSI. The Centres for Disease Control reporting definition of either superficial or deep infection at 30 days will be used as the outcome measure definition. SWD will be classified as per the World Union of Wound Healing Societies grading system (grade I-IV). We will assess recruitment rate, and adherence to intervention and follow-up. We will assess the potential effectiveness of NPWT in the prevention of postpartum surgical wound complications at three time points during the study; postoperative days 5, 14 and 30, after which the participant will be closed out of the trial. We will use statistical methods to determine efficacy, and risk stratification will be conducted to determine the SWD risk profile of the participant. Follow-up at day 30 will assess superficial and deep infection, and wound dehiscence (grade I-IV) and the core outcome data set for wound complications. This study will collect health-related quality of life (European Quality of Life 5-Dimensions 5-Level Scale), mortality and late complications such as further surgery with a cost analysis conducted. The primary analysis will be by intention-to-treat. This clinical trial protocol follows the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) and the Consolidated Standards of Reporting Trials guidelines.
ETHICS AND DISSEMINATION


Ethics approval was obtained through St John of God Health Care (HREC1409), Western Australia Department of Health King Edward Memorial Hospital (HREC3111). Study findings will be published in peer-reviewed journals and presented at international conferences. We used the SPIRIT checklist when writing our study protocol.
TRIAL REGISTRATION NUMBER


Australian and New Zealand Clinical Trials Registry (ACTRN12618002006224p).",2020,Postoperative surgical site infections (SSIs) and wound complications are the most common and costly event following a caesarean section.,"['448 patients will be conducted across two metropolitan hospitals in Perth, Western Australia, which provide obstetric and midwifery services', 'cesarean section at-risk population', 'pregnant women in the last trimester, prior to their admission into the healthcare facility for delivery of their child', '448 participants to either the']","['NPWT', 'negative pressure wound therapy', 'interventional (negative pressure wound therapy (NPWT) dressing, n=224) or comparator arm (non-NPWT dressing']","['Postoperative surgical site infections (SSIs) and wound complications', 'occurrence of surgical wound dehiscence (SSWD) or SSI', 'caesarean section rate', 'surgical wound complications', 'complication rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0020029', 'cui_str': 'Urban Hospitals'}, {'cui': 'C0043128', 'cui_str': 'Western Australia'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0026082', 'cui_str': 'Midwifery'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0242444', 'cui_str': 'Populations at Risk'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0032981', 'cui_str': 'Third trimester pregnancy'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0332286', 'cui_str': 'Into'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0680063', 'cui_str': 'Child of'}]","[{'cui': 'C1956078', 'cui_str': 'Topical Negative-Pressure Therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0038940', 'cui_str': 'Dehiscence of surgical wound'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0332803', 'cui_str': 'Surgical wound'}]",448.0,0.122106,Postoperative surgical site infections (SSIs) and wound complications are the most common and costly event following a caesarean section.,"[{'ForeName': 'Kylie', 'Initials': 'K', 'LastName': 'Sandy-Hodgetts', 'Affiliation': 'Skin Integrity Research Institute, School of Biomedical Sciences, University of Western Australia, Crawley, Western Australia, Australia kylie.sandy-hodgetts@uwa.edu.au.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Parsons', 'Affiliation': 'School of Occupational Therapy, Social Work and Speech Pathology, Curtin University Faculty of Health Sciences, Perth, Western Australia, Australia.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Norman', 'Affiliation': 'School of Public Health, Curtin University Faculty of Health Sciences, Perth, Western Australia, Australia.'}, {'ForeName': 'Mark W', 'Initials': 'MW', 'LastName': 'Fear', 'Affiliation': 'Burn Injury Research Unit, School of Biomedical Sciences, University of Western Australia, Crawley, Western Australia, Australia.'}, {'ForeName': 'Fiona M', 'Initials': 'FM', 'LastName': 'Wood', 'Affiliation': 'Fiona Stanley and Princess Margaret Hospitals, Burns Service of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'Scott W', 'Initials': 'SW', 'LastName': 'White', 'Affiliation': 'Department of Obstetrics and Gynaecology, The University of Western Australia Faculty of Health and Medical Sciences, Perth, Western Australia, Australia.'}]",BMJ open,['10.1136/bmjopen-2019-035727']
1509,33077560,"Group-based intervention to improve developmental status among children age 6-18 months in rural Shanxi province, China: a study protocol for a cluster randomised controlled trial.","INTRODUCTION


Early childhood development (ECD) is a critical component for building the foundation of future physical and emotional health and subsequent academic success. The quality of the home environment to promote development is an important factor in ECD. Since large rural-urban disparities in the home environment exist in China, there is a critical need to develop and evaluate interventions to promote ECD in rural areas. Individual center-based or home-based interventions dominate the current ECD programmes in rural China. However, group-based interventions offer potential advantages in terms of both effectiveness and cost. Thus, we aim to: (1) evaluate the effectiveness of an integrated group-based intervention, the Care Group Intervention, in enhancing ECD among children age 6-18 months and (2) conduct a cost-effectiveness analysis.
METHODS AND ANALYSIS


The Care Group Intervention uses a cluster (by township) randomised controlled trial conducted in Fenxi county, Shanxi province, China, from July 2019, for 1 year. The intervention focuses on five key components of nurturing care including good health, adequate nutrition, responsive caregiving, security and safety, and opportunities for early learning. The intervention comprises small groups of 3-10 children within a certain age range and their primary caregivers that are led by well-trained local facilitators. Outcomes includes infants' developmental quotient (Bayley Scales of Infant Development III, Ages & Stages Questionnaire: Social-Emotional, second edition); anaemia (HemoCue Hb 301+); nurturing environment (Infant/Toddler Home Observation for Measurement of the Environment), parent-child interaction (Teaching Scale) and caregiver depression (Center for Epidemiological Studies Depression). Cost data are collected throughout the entire study to carry out a cost-effectiveness analysis.
ETHICS AND DISSEMINATION


This study was approved by the Ethical Committee of Capital Institute of Pediatrics, Beijing, China on 10 July 2018 (SHERLL2018014). Findings and results from this project will be disseminated via publications and presentations.
TRIAL REGISTRATION NUMBER


Chinese Clinical Trials Registry: ChiCTR1900022894. Registered on 30 April 2019.",2020,"The Care Group Intervention uses a cluster (by township) randomised controlled trial conducted in Fenxi county, Shanxi province, China, from July 2019, for 1 year.","['children age 6-18 months in rural Shanxi province, China', 'in rural China']","['Individual center-based or home-based interventions dominate the current ECD programmes', 'integrated group-based intervention, the Care Group Intervention']","[""infants' developmental quotient (Bayley Scales of Infant Development III, Ages & Stages Questionnaire: Social-Emotional, second edition); anaemia (HemoCue Hb 301+); nurturing environment (Infant/Toddler Home Observation for Measurement of the Environment), parent-child interaction (Teaching Scale) and caregiver depression (Center for Epidemiological Studies Depression""]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0599196', 'cui_str': 'Early childhood'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0458003', 'cui_str': 'Developmental'}, {'cui': 'C0451021', 'cui_str': 'Bayley scale of infant development'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0441795', 'cui_str': 'Second edition'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0682053', 'cui_str': 'Toddler'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0030542', 'cui_str': 'Parent-Child Relationship'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0002783', 'cui_str': 'Studies, Epidemiologic'}]",,0.0629444,"The Care Group Intervention uses a cluster (by township) randomised controlled trial conducted in Fenxi county, Shanxi province, China, from July 2019, for 1 year.","[{'ForeName': 'Mengxue', 'Initials': 'M', 'LastName': 'Xu', 'Affiliation': 'Department of Integrated Early Childhood Development, Capital Institute of Pediatrics, Beijing, China.'}, {'ForeName': 'Aihua', 'Initials': 'A', 'LastName': 'Liu', 'Affiliation': 'Department of Integrated Early Childhood Development, Capital Institute of Pediatrics, Beijing, China.'}, {'ForeName': 'Chunxia', 'Initials': 'C', 'LastName': 'Zhao', 'Affiliation': 'UNICEF China Office, Beijing, China.'}, {'ForeName': 'Hai', 'Initials': 'H', 'LastName': 'Fang', 'Affiliation': 'China Center for Health Development Studies, Peking University, Beijing, China.'}, {'ForeName': 'Xiaona', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': 'UNICEF China Office, Beijing, China.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Berman', 'Affiliation': 'Center for Global Health (CGH), Colorado School of Public Health, Aurora, Colorado, USA.'}, {'ForeName': 'Hongyan', 'Initials': 'H', 'LastName': 'Guan', 'Affiliation': 'Department of Integrated Early Childhood Development, Capital Institute of Pediatrics, Beijing, China cip_ghy@yeah.net.'}]",BMJ open,['10.1136/bmjopen-2020-037156']
1510,33077567,"Efficacy and safety of exogenous surfactant therapy in patients under 12 months of age invasively ventilated for severe bronchiolitis (SURFABRON): protocol for a multicentre, randomised, double-blind, controlled, non-profit trial.","INTRODUCTION


Some evidence indicates that exogenous surfactant therapy may be effective in infants with acute viral bronchiolitis, even though more confirmatory data are needed. To date, no large multicentre trials have evaluated the effectiveness and safety of exogenous surfactant in severe cases of bronchiolitis requiring invasive mechanical ventilation (IMV).
METHODS AND ANALYSIS


This is a multicentre randomised, placebo-controlled, double-blind study, performed in 19 Italian paediatric intensive care units (PICUs). Eligible participants are infants under the age of 12 months hospitalised in a PICU, suffering from severe acute hypoxaemic bronchiolitis, requiring IMV. We adopted a more restrictive definition of bronchiolitis, including only infants below 12 months of age, to maintain the population as much homogeneous as possible. The primary outcome is to evaluate whether exogenous surfactant therapy (Curosurf, Chiesi Pharmaceuticals, Italy) is effective compared with placebo (air) in reducing the duration of IMV in the first 14 days of hospitalisation, in infants suffering from acute hypoxaemic viral bronchiolitis. Secondary outcomes are duration of non-invasive mechanical ventilation in the post-extubation phase, number of cases requiring new intubation after previous extubation within 14 days from randomisation, PICU and hospital length of stay (LOS), duration of oxygen dependency, effects on oxygenation and ventilatory parameters during invasive mechanical respiratory support, need for repeating treatment within 24 hours of first treatment, use of other interventions (eg, high-frequency oscillatory ventilation, nitric oxide, extracorporeal membrane oxygenation), mortality within the first 14 days of PICU stay and before hospital discharge, side effects and serious adverse events.
ETHICS AND DISSEMINATION


The trial design and protocol have received approval by the Italian National Agency for Drugs (AIFA) and by the Regional Ethical Committee of Verona University Hospital (1494CESC). Findings will be disseminated through publication in peer-reviewed journals, conference/meeting presentations and media.
TRIAL REGISTRATION NUMBER


Clinicaltrials.gov, issue date 22 May 2019. NCT03959384.",2020,"To date, no large multicentre trials have evaluated the effectiveness and safety of exogenous surfactant in severe cases of bronchiolitis requiring invasive mechanical ventilation (IMV).
","['patients under 12 months of age invasively ventilated for severe bronchiolitis (SURFABRON', 'infants with acute viral bronchiolitis', 'severe cases of bronchiolitis requiring invasive mechanical ventilation (IMV', 'Italian National Agency for Drugs (AIFA) and by the Regional Ethical Committee of Verona University Hospital (1494CESC', '19 Italian paediatric intensive care units (PICUs', 'Eligible participants are infants under the age of 12 months hospitalised in a PICU, suffering from severe acute hypoxaemic bronchiolitis, requiring IMV']","['exogenous surfactant therapy', 'placebo', 'exogenous surfactant']","['Efficacy and safety', 'exogenous surfactant therapy (Curosurf, Chiesi Pharmaceuticals, Italy) is effective compared with placebo (air) in reducing the duration of IMV', 'duration of non-invasive mechanical ventilation in the post-extubation phase, number of cases requiring new intubation after previous extubation within 14 days from randomisation, PICU and hospital length of stay (LOS), duration of oxygen dependency, effects on oxygenation and ventilatory parameters during invasive mechanical respiratory support, need for repeating treatment within 24 hours of first treatment, use of other interventions (eg, high-frequency oscillatory ventilation, nitric oxide, extracorporeal membrane oxygenation), mortality within the first 14 days of PICU stay and before hospital discharge, side effects and serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0001311', 'cui_str': 'Acute bronchiolitis'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0339941', 'cui_str': 'Acute viral bronchiolitis'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0022275', 'cui_str': 'Italian language'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0026531', 'cui_str': 'Morality'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0021710', 'cui_str': 'Pediatric intensive care unit'}, {'cui': 'C1046445', 'cui_str': 'Picus'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]","[{'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0034085', 'cui_str': 'Lung surfactant'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0034085', 'cui_str': 'Lung surfactant'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0111318', 'cui_str': 'Curosurf'}, {'cui': 'C0013058', 'cui_str': 'Pharmaceutical dose form'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1046445', 'cui_str': 'Picus'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0011546', 'cui_str': 'Dependency, Psychology'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0419017', 'cui_str': 'High frequency oscillatory ventilation'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0015357', 'cui_str': 'Extracorporeal membrane oxygenation'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.538664,"To date, no large multicentre trials have evaluated the effectiveness and safety of exogenous surfactant in severe cases of bronchiolitis requiring invasive mechanical ventilation (IMV).
","[{'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Biban', 'Affiliation': 'Department of Neonatal and Paediatric Critical Care, Azienda Ospedaliera Universitaria Integrata Verona, Verona, Italy paolo.biban@aovr.veneto.it.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Conti', 'Affiliation': 'Paediatric Anesthesia and Intensive Care, Policlinico Universitario Agostino Gemelli, Roma, Italy.'}, {'ForeName': 'Andrea Michele', 'Initials': 'AM', 'LastName': 'Wolfler', 'Affiliation': 'Paediatric Anesthesia and Intensive Care, Ospedale dei Bambini Vittore Buzzi, Milano, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Carlassara', 'Affiliation': 'Department of Neonatal and Paediatric Critical Care, Azienda Ospedaliera Universitaria Integrata Verona, Verona, Italy.'}, {'ForeName': 'Eloisa', 'Initials': 'E', 'LastName': 'Gitto', 'Affiliation': 'Neonatal and Paediatric Intensive Care, Azienda Ospedaliera Universitaria G. Martino, Messina, Italy.'}, {'ForeName': 'Immacolata', 'Initials': 'I', 'LastName': 'Rulli', 'Affiliation': 'Neonatal and Paediatric Intensive Care, Azienda Ospedaliera Universitaria G. Martino, Messina, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Moscatelli', 'Affiliation': 'Paediatric Anesthesia and Intensive Care, Ospedale Giannina Gaslini, Genova, Italy.'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Micalizzi', 'Affiliation': 'Paediatric Anesthesia and Intensive Care, Ospedale Giannina Gaslini, Genova, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Savron', 'Affiliation': 'Paediatric Anesthesia and Intensive Care, IRCCS Materno Infantile Burlo Garofolo, Trieste, Italy.'}, {'ForeName': 'Raffaella', 'Initials': 'R', 'LastName': 'Sagredini', 'Affiliation': 'Paediatric Anesthesia and Intensive Care, IRCCS Materno Infantile Burlo Garofolo, Trieste, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Genoni', 'Affiliation': 'Neonatal and Paediatric Intensive Care, Azienda Ospedaliero-Universitaria Maggiore della Carità, Novara, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Binotti', 'Affiliation': 'Neonatal and Paediatric Intensive Care, Azienda Ospedaliero-Universitaria Maggiore della Carità, Novara, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Caramelli', 'Affiliation': ""Paediatric Anesthesia and Intensive Care, Azienda Ospedaliera-Universitaria Sant'Orsola-Malpighi, Bologna, Italy.""}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Fae', 'Affiliation': ""Paediatric Anesthesia and Intensive Care, Azienda Ospedaliera-Universitaria Sant'Orsola-Malpighi, Bologna, Italy.""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Pettenazzo', 'Affiliation': 'Paediatric Intensive Care, Azienda Ospedaliera Universitaria Padova, Padua, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Stritoni', 'Affiliation': 'Paediatric Intensive Care, Azienda Ospedaliera Universitaria Padova, Padua, Italy.'}, {'ForeName': 'Luigia', 'Initials': 'L', 'LastName': ""D'Amato"", 'Affiliation': 'Paediatric Anesthesia and Intensive Care, Ospedale Pediatrico Santobbono, Napoli, Italy.'}, {'ForeName': 'Geremia', 'Initials': 'G', 'LastName': 'Zito Marinosci', 'Affiliation': 'Paediatric Anesthesia and Intensive Care, Ospedale Pediatrico Santobbono, Napoli, Italy.'}, {'ForeName': 'Edoardo', 'Initials': 'E', 'LastName': 'Calderini', 'Affiliation': 'Paediatric Anesthesia and Intensive Care, Ospedale Maggiore Policlinico, Milano, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Scalia Catenacci', 'Affiliation': 'Paediatric Anesthesia and Intensive Care, Ospedale Maggiore Policlinico, Milano, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Berardi', 'Affiliation': 'Neonatal Intensive Care, Azienda Ospedaliero-Universitaria Policlinico, Modena, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Torcetta', 'Affiliation': 'Neonatal Intensive Care, Azienda Ospedaliero-Universitaria Policlinico, Modena, Italy.'}, {'ForeName': 'Ezio', 'Initials': 'E', 'LastName': 'Bonanomi', 'Affiliation': 'Paediatric Anesthesia and Intensive Care, ASST Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Bonacina', 'Affiliation': 'Paediatric Anesthesia and Intensive Care, ASST Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Ivani', 'Affiliation': ""Paediatric Anesthesia and Intensive Care, Ospedale Infantile Regina Margherita Sant'Anna, Torino, Italy.""}, {'ForeName': 'Pierantonio', 'Initials': 'P', 'LastName': 'Santuz', 'Affiliation': 'Department of Neonatal and Paediatric Critical Care, Azienda Ospedaliera Universitaria Integrata Verona, Verona, Italy.'}]",BMJ open,['10.1136/bmjopen-2020-038780']
1511,33077722,"Randomized, multicenter, open-label trial of autologous cytokine-induced killer cell immunotherapy plus chemotherapy for squamous non-small-cell lung cancer: NCT01631357.",,2020,,['squamous non-small-cell lung cancer'],['autologous cytokine-induced killer cell immunotherapy plus chemotherapy'],[],"[{'cui': 'C4509816', 'cui_str': 'Squamous non-small cell lung cancer'}]","[{'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C2348032', 'cui_str': 'CIK Cells'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]",[],,0.0658967,,"[{'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': ""Department of Immunology and Biotherapy, Key Laboratory of Cancer Immunology and Biotherapy, Key Laboratory of Cancer Prevention and Therapy, Tianjin's Clinical Research Center for Cancer, Tianjin Medical University Cancer Institute and Hospital, Tianjin, 300060, China.""}, {'ForeName': 'Quanli', 'Initials': 'Q', 'LastName': 'Gao', 'Affiliation': 'Department of Immunotherapy, Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital, Zhengzhou, 450008, Henan, China.'}, {'ForeName': 'Jingting', 'Initials': 'J', 'LastName': 'Jiang', 'Affiliation': 'Department of Tumor Biological Treatment, Third Affiliated Hospital of Soochow University, Changzhou, 213003, Jiangsu, China.'}, {'ForeName': 'Junping', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Oncology, Shanxi Bethune Hospital, Taiyuan, 030032, Shanxi, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Song', 'Affiliation': 'Cancer Biotherapy Center, Third Affiliated Hospital of Kunming Medical University (Tumor Hospital of Yunnan Province), Kunming, 650118, Yunnan, China.'}, {'ForeName': 'Jiuwei', 'Initials': 'J', 'LastName': 'Cui', 'Affiliation': 'Cancer Center, First Hospital of Jilin University, Changchun, 130021, Jilin, China.'}, {'ForeName': 'Yunbin', 'Initials': 'Y', 'LastName': 'Ye', 'Affiliation': 'Laboratory of Immuno-Oncology, Fujian Cancer Hospital & Fujian Medical University Cancer Hospital, Fuzhou, 350014, Fujian, China.'}, {'ForeName': 'Zhiyu', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Immuno-Oncology, Fourth Hospital of Hebei Medical University, Shijiazhuang, 050011, Hebei, China.'}, {'ForeName': 'Xinwei', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ""Department of Immunology and Biotherapy, Key Laboratory of Cancer Immunology and Biotherapy, Key Laboratory of Cancer Prevention and Therapy, Tianjin's Clinical Research Center for Cancer, Tianjin Medical University Cancer Institute and Hospital, Tianjin, 300060, China. zhangxinwei@tjmuch.com.""}, {'ForeName': 'Xiubao', 'Initials': 'X', 'LastName': 'Ren', 'Affiliation': ""Department of Immunology and Biotherapy, Key Laboratory of Cancer Immunology and Biotherapy, Key Laboratory of Cancer Prevention and Therapy, Tianjin's Clinical Research Center for Cancer, Tianjin Medical University Cancer Institute and Hospital, Tianjin, 300060, China. renxiubao@tjmuch.com.""}]",Signal transduction and targeted therapy,['10.1038/s41392-020-00337-x']
1512,33077724,Author Correction: A cluster-randomized trial of the effectiveness of a triple-faceted intervention promoting adherence to primary care physician visits by diabetes patients: J-DOIT2 large-scale trial (J-DOIT2-LT).,An amendment to this paper has been published and can be accessed via a link at the top of the paper.,2020,An amendment to this paper has been published and can be accessed via a link at the top of the paper.,['primary care physician visits by diabetes patients'],['triple-faceted intervention'],[],"[{'cui': 'C0033131', 'cui_str': 'Primary care physician'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0226341,An amendment to this paper has been published and can be accessed via a link at the top of the paper.,"[{'ForeName': 'Mitsuhiko', 'Initials': 'M', 'LastName': 'Noda', 'Affiliation': 'Department of Diabetes, Metabolism and Endocrinology, Ichikawa Hospital, International University of Health and Welfare, 6-1-14 Kounodai, Ichikawa, Chiba, Japan. noda-m@iuhw.ac.jp.'}, {'ForeName': 'Yasuaki', 'Initials': 'Y', 'LastName': 'Hayashino', 'Affiliation': 'Department of Endocrinology, Tenri Hospital, 200 Mishimacho, Tenri, Nara, Japan.'}, {'ForeName': 'Katsuya', 'Initials': 'K', 'LastName': 'Yamazaki', 'Affiliation': 'First Department of Internal Medicine, Faculty of Medicine, Toyama University, Sugitani, Toyama, Toyama, 2630, Japan.'}, {'ForeName': 'Hikari', 'Initials': 'H', 'LastName': 'Suzuki', 'Affiliation': 'First Department of Internal Medicine, Faculty of Medicine, Toyama University, Sugitani, Toyama, Toyama, 2630, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Goto', 'Affiliation': 'Diabetes Research Center, National Center for Global Health and Medicine, 1-21-1 Toyama, Shinjuku-ku, Tokyo, Japan.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Kato', 'Affiliation': 'Toranomon Hospital Health Management Center and Diagnostic Imaging Center, 2-2-2 Toranomon, Minato-ku, Tokyo, Japan.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Izumi', 'Affiliation': 'Center for Clinical Sciences, National Center for Global Health and Medicine, 1-21-1 Toyama, Shinjuku-ku, Tokyo, Japan.'}, {'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Kobayashi', 'Affiliation': 'First Department of Internal Medicine, Faculty of Medicine, Toyama University, Sugitani, Toyama, Toyama, 2630, Japan.'}]",Scientific reports,['10.1038/s41598-020-70072-4']
1513,33077817,Enhanced physical and cognitive performance in active duty Airmen: evidence from a randomized multimodal physical fitness and nutritional intervention.,"Achieving military mission objectives requires high levels of performance from Airmen who operate under extreme physical and cognitive demands. Thus, there is a critical need to establish scientific interventions to enhance physical fitness and cognitive performance-promoting the resilience of Airmen and aiding in mission success. We therefore conducted a comprehensive, 12-week randomized controlled trial in active-duty Air Force Airmen (n = 148) to compare the efficacy of a multimodal intervention comprised of high-intensity interval aerobic fitness and strength training paired with a novel nutritional supplement [comprised of β-hydroxy β-methylbutyrate (HMB), lutein, phospholipids, DHA and selected micronutrients including B12 and folic acid] to high-intensity interval aerobic fitness and strength training paired with a standard of care placebo beverage. The exercise intervention alone improved several dimensions of physical fitness [strength and endurance (+ 8.3%), power (+ 0.85%), mobility and stability (+ 22%), heart rate (- 1.1%) and lean muscle mass (+ 1.4%)] and cognitive function [(episodic memory (+ 9.5%), processing efficiency (+ 7.5%), executive function reaction time (- 4.8%) and fluid intelligence accuracy (+ 19.5%)]. Relative to exercise training alone, the multimodal fitness and nutritional intervention further improved working memory (+ 9.0%), fluid intelligence reaction time (- 7.7%), processing efficiency (+ 1.8%), heart rate (- 2.4%) and lean muscle mass (+ 1.5%). These findings establish the efficacy of a multimodal intervention that incorporates aerobic fitness and strength training with a novel nutritional supplement to enhance military performance objectives and to provide optimal exercise training and nutritional support for the modern warfighter.",2020,"Relative to exercise training alone, the multimodal fitness and nutritional intervention further improved working memory (+ 9.0%), fluid intelligence reaction time (- 7.7%), processing efficiency (+ 1.8%), heart rate (- 2.4%) and lean muscle mass (+ 1.5%).","['active duty Airmen', 'active-duty Air Force Airmen (n\u2009=\u2009148']","['multimodal intervention comprised of high-intensity interval aerobic fitness and strength training paired with a novel nutritional supplement [comprised of β-hydroxy β-methylbutyrate (HMB), lutein, phospholipids, DHA and selected micronutrients including B12 and folic acid']","['lean muscle mass', 'processing efficiency', 'executive function reaction time', 'cognitive function [(episodic memory', 'fluid intelligence reaction time', 'fluid intelligence accuracy', 'mobility and stability', 'working memory', 'heart rate', 'several dimensions of physical fitness [strength and endurance', 'Enhanced physical and cognitive performance']","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C4521691', 'cui_str': 'US Military enlisted E2'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0443221', 'cui_str': 'Forced'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0043328', 'cui_str': 'Lutein'}, {'cui': 'C0031676', 'cui_str': 'Phospholipids'}, {'cui': 'C0142831', 'cui_str': 'sodium dehydroacetate'}, {'cui': 'C0040577', 'cui_str': 'Trace element'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0042845', 'cui_str': 'Vitamin B 12'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}]","[{'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0561843', 'cui_str': 'Episodic memory'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0021704', 'cui_str': 'Intelligence'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",,0.0233174,"Relative to exercise training alone, the multimodal fitness and nutritional intervention further improved working memory (+ 9.0%), fluid intelligence reaction time (- 7.7%), processing efficiency (+ 1.8%), heart rate (- 2.4%) and lean muscle mass (+ 1.5%).","[{'ForeName': 'Christopher E', 'Initials': 'CE', 'LastName': 'Zwilling', 'Affiliation': 'Decision Neuroscience Laboratory, University of Illinois, 405 North Mathews Avenue, Urbana, IL, 61801, USA.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Strang', 'Affiliation': 'Applied Neuroscience Branch, Wright Patterson Air Force Base, Dayton, OH, USA.'}, {'ForeName': 'Evan', 'Initials': 'E', 'LastName': 'Anderson', 'Affiliation': 'Decision Neuroscience Laboratory, University of Illinois, 405 North Mathews Avenue, Urbana, IL, 61801, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Jurcsisn', 'Affiliation': 'Applied Neuroscience Branch, Wright Patterson Air Force Base, Dayton, OH, USA.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Johnson', 'Affiliation': 'Applied Neuroscience Branch, Wright Patterson Air Force Base, Dayton, OH, USA.'}, {'ForeName': 'Tapas', 'Initials': 'T', 'LastName': 'Das', 'Affiliation': 'Discovery Research, Abbott Nutrition, Columbus, OH, USA.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Kuchan', 'Affiliation': 'Discovery Research, Abbott Nutrition, Columbus, OH, USA.'}, {'ForeName': 'Aron K', 'Initials': 'AK', 'LastName': 'Barbey', 'Affiliation': 'Decision Neuroscience Laboratory, University of Illinois, 405 North Mathews Avenue, Urbana, IL, 61801, USA. barbey@illinois.edu.'}]",Scientific reports,['10.1038/s41598-020-74140-7']
1514,33077839,Adjuvant chemotherapy after radical nephroureterectomy improves the survival outcome of high-risk upper tract urothelial carcinoma patients with cardiovascular comorbidity.,"This prospective randomized comparative trial study aimed to evaluate the therapeutic outcomes of radical nephroureterectomy and adjuvant chemotherapy (ACT) used in combination in high risk upper tract urothelial carcinoma (UTUC) patients with cardiovascular comorbidity. Based on the inclusion criteria of high-risk UTUC in EAU guidelines (updated in 2014), all eligible patients treated in our hospital from January 2014 to March 2018 were included, and cases with late disease, renal dysfunction, severe cardiopulmonary disease or other malignant tumors were excluded. The cases were randomized into two groups based on treatment regimen. Multivariate analyses were performed to analyze the influencing factors of survival outcome in the enrolled patients. The Cox proportional-hazards model and the Kaplan-Meier method were employed to assess progression free survival (PFS), overall survival (OS) and cancer specific survival (CSS). In addition, the potential adverse effects of chemotherapy were actively monitored. A total of 176 high-risk UTUC individuals with cardiovascular comorbidity were enrolled and evaluated in this study. Median follow-up durations were 30 months (range 6-54) in the RNU (n = 82) group and 36 months (range 6-54) in the RNU + ACT (n = 94) group. Multivariable analysis indicated that peri-operative cardiovascular events risk grade was independent prognostic factor for OS. Tumor size was independent prognostic factor for PFS and CSS. BMI and lymphovacular invasion were significant predictors of PFS. Clinical stage, lymph node involvement, and tumor grade were significant predictors of PFS, OS and CSS in these patients. Especially, chemotherapy was helpful in improving PFS [P < 0.001, HR = 6.327 (5.115-7.793)], OS [P = 0.013, HR = 2.336 (1.956-2.883)] and CSS [P = 0.008, HR = 3.073 (2.533-3.738)]. Kaplan-Meier analysis demonstrated that the oncologic outcomes of RNU treated high-risk UTUC patients were improved much significantly by ACT, including PFS [P = 0.0033, HR = 3.78 (3.13-4.55)], OS [P = 0.0397, HR = 1.39 (1.01-1.75)] and CSS [P = 0.0255, HR = 1.26 (1.07-1.45)]. Further analysis of the lymph node positive subgroup showed that the median time of oncologic events was enhanced in RNU + ACT treated individuals in comparison with the RNU group, including PFS (11.4 months vs. 31.9 months, P = 0.0018), OS (26.8 months vs. 36.3 months, P = 0.0255) and CSS (28.2 months vs. 39.3 months, P = 0.0197). In the T3/4 cohort, significantly increased median PFS (13.9 months vs. 36.3 months, P = 0.0217), OS (20.6 months vs. 32.2 months, P = 0.0183) and CSS (21.9 months vs. 38.4 months, P = 0.0226) were obtained in the combination group. Additionally, no severe adverse events (over grade 4) associated with chemotherapy were detected in the RNU + ACT group. In conclusion, ACT after radical surgery has statistically significant therapeutic effects on PFS, OS and CSS in high-risk UTUC patients with cardiovascular comorbidity.",2020,"In the T3/4 cohort, significantly increased median PFS (13.9 months vs. 36.3 months, P = 0.0217), OS (20.6 months vs. 32.2 months, P = 0.0183) and CSS (21.9 months vs. 38.4 months, P = 0.0226) were obtained in the combination group.","['eligible patients treated in our hospital from January 2014 to March 2018 were included, and cases with late disease, renal dysfunction, severe cardiopulmonary disease or other malignant tumors were excluded', 'high-risk upper tract urothelial carcinoma patients with cardiovascular comorbidity', '176 high-risk UTUC individuals with cardiovascular comorbidity', 'high-risk UTUC patients with cardiovascular comorbidity', 'high risk upper tract urothelial carcinoma (UTUC) patients with cardiovascular comorbidity']","['radical nephroureterectomy and adjuvant chemotherapy (ACT', 'Adjuvant chemotherapy', 'radical nephroureterectomy']","['median time of oncologic events', 'survival outcome', 'BMI and lymphovacular invasion', 'progression free survival (PFS), overall survival (OS) and cancer specific survival (CSS', 'severe adverse events', 'OS', 'PFS', 'CSS', 'median PFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0034072', 'cui_str': 'Cor pulmonale'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0007138', 'cui_str': 'Transitional cell carcinoma'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0027732', 'cui_str': 'Nephroureterectomy'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205478', 'cui_str': 'Oncologic'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1269955', 'cui_str': 'Tumour invasion'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}]",176.0,0.0418238,"In the T3/4 cohort, significantly increased median PFS (13.9 months vs. 36.3 months, P = 0.0217), OS (20.6 months vs. 32.2 months, P = 0.0183) and CSS (21.9 months vs. 38.4 months, P = 0.0226) were obtained in the combination group.","[{'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Luo', 'Affiliation': ""Department of Urology, Beijing Anzhen Hospital, Capital Medical University, Anzhenli Street, Chaoyang District, Beijing, 100029, People's Republic of China. luoyonganzhen@163.com.""}, {'ForeName': 'Bingfu', 'Initials': 'B', 'LastName': 'Feng', 'Affiliation': ""Department of Urology, Beijing Anzhen Hospital, Capital Medical University, Anzhenli Street, Chaoyang District, Beijing, 100029, People's Republic of China.""}, {'ForeName': 'Dechao', 'Initials': 'D', 'LastName': 'Wei', 'Affiliation': ""Department of Urology, Beijing Anzhen Hospital, Capital Medical University, Anzhenli Street, Chaoyang District, Beijing, 100029, People's Republic of China.""}, {'ForeName': 'Yili', 'Initials': 'Y', 'LastName': 'Han', 'Affiliation': ""Department of Urology, Beijing Anzhen Hospital, Capital Medical University, Anzhenli Street, Chaoyang District, Beijing, 100029, People's Republic of China.""}, {'ForeName': 'Mingchuan', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': ""Department of Urology, Beijing Anzhen Hospital, Capital Medical University, Anzhenli Street, Chaoyang District, Beijing, 100029, People's Republic of China.""}, {'ForeName': 'Jiahui', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': ""Department of Urology, Beijing Anzhen Hospital, Capital Medical University, Anzhenli Street, Chaoyang District, Beijing, 100029, People's Republic of China.""}, {'ForeName': 'Yunhua', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': ""Department of Urology, Beijing Anzhen Hospital, Capital Medical University, Anzhenli Street, Chaoyang District, Beijing, 100029, People's Republic of China.""}, {'ForeName': 'Zhu', 'Initials': 'Z', 'LastName': 'Hou', 'Affiliation': ""Department of Urology, Beijing Anzhen Hospital, Capital Medical University, Anzhenli Street, Chaoyang District, Beijing, 100029, People's Republic of China.""}, {'ForeName': 'Yongguang', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': ""Department of Urology, Beijing Anzhen Hospital, Capital Medical University, Anzhenli Street, Chaoyang District, Beijing, 100029, People's Republic of China.""}]",Scientific reports,['10.1038/s41598-020-74940-x']
1515,33077895,"A phase 2/3 randomized clinical trial followed by an open-label extension to evaluate the effectiveness of elamipretide in Barth syndrome, a genetic disorder of mitochondrial cardiolipin metabolism.","PURPOSE


To evaluate effectiveness of elamipretide in Barth syndrome (BTHS), a genetic condition of defects in TAZ, which causes abnormal cardiolipin on the inner mitochondrial membrane.
METHODS


We performed a randomized, double-blind, placebo-controlled crossover trial followed by an open-label extension in BTHS to test the effect of elamipretide, a mitochondrial tetrapeptide that interacts with cardiolipin. In part 1, 12 subjects were randomized to 40 mg per day of elamipretide or placebo for 12 weeks, followed by a 4-week washout and then 12 weeks on the opposite arm. Ten subjects continued on the open-label extension (part 2) of 40 mg per day of elamipretide, with eight subjects reaching 36 weeks. Primary endpoints were improvement on the 6-minute walk test (6MWT) and improvement on a BTHS Symptom Assessment (BTHS-SA) scale.
RESULTS


In part 1 neither primary endpoint was met. At 36 weeks in part 2, there were significant improvements in 6MWT (+95.9 m, p = 0.024) and BTHS-SA (-2.1 points, p = 0.031). There were also significant improvements in secondary endpoints including knee extensor strength, patient global impression of symptoms, and some cardiac parameters.
CONCLUSION


In this interventional clinical trial in BTHS, daily administration of elamipretide led to improvement in BTHS symptoms.",2020,"Primary endpoints were improvement on the 6-minute walk test (6MWT) and improvement on a BTHS Symptom Assessment (BTHS-SA) scale.
",['12 subjects'],"['elamipretide', 'placebo', 'elamipretide or placebo']","['6-minute walk test (6MWT) and improvement on a BTHS Symptom Assessment (BTHS-SA) scale', '6MWT', 'BTHS symptoms', 'BTHS-SA', 'knee extensor strength, patient global impression of symptoms, and some cardiac parameters']",[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C0574083', 'cui_str': '3-Methylglutaconic aciduria type 2'}, {'cui': 'C3494437', 'cui_str': 'Symptom Assessment'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",12.0,0.297293,"Primary endpoints were improvement on the 6-minute walk test (6MWT) and improvement on a BTHS Symptom Assessment (BTHS-SA) scale.
","[{'ForeName': 'W', 'Initials': 'W', 'LastName': 'Reid Thompson', 'Affiliation': 'Department of Pediatric Cardiology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'Hornby', 'Affiliation': 'Department of Physical Therapy, Kennedy Krieger Institute, Baltimore, MD, USA.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Manuel', 'Affiliation': 'Department of Genetic Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Bradley', 'Affiliation': 'Department of Physical Therapy, Kennedy Krieger Institute, Baltimore, MD, USA.'}, {'ForeName': 'Janice', 'Initials': 'J', 'LastName': 'Laux', 'Affiliation': 'Department of Physical Therapy, Kennedy Krieger Institute, Baltimore, MD, USA.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Carr', 'Affiliation': 'Stealth BioTherapeutics Inc, Newton, MA, USA.'}, {'ForeName': 'Hilary J', 'Initials': 'HJ', 'LastName': 'Vernon', 'Affiliation': 'Department of Genetic Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA. hvernon1@jhmi.edu.'}]",Genetics in medicine : official journal of the American College of Medical Genetics,['10.1038/s41436-020-01006-8']
1516,33077900,The short-term effects of head-mounted virtual-reality on neuropathic pain intensity in people with spinal cord injury pain: a randomised cross-over pilot study.,"STUDY DESIGN


Within-subject, randomised cross-over trial.
OBJECTIVES


To determine whether a commercially available 3D head-mounted (HMD) virtual reality (VR) device results in significant reductions in neuropathic pain compared to using a 2D screen device in people with spinal cord injury (SCI).
SETTING


Greenwich Hospital, Sydney, Australia.
METHODS


Sixteen men with established SCI and chronic neuropathic pain participated in a single-session randomised cross-over trial. We compared the effects of 3D HMD VR and a 2D screen application on SCI neuropathic pain intensity and levels of perceived presence.
RESULTS


Participants reported significantly lower pain intensity after 3D HMD VR compared to 2D screen application (1.9 ± SD 1.8 versus 3.4 ± SD 1.6, mean 95% CI: 1.5, P < 0.0001). Participants reported significantly higher perceived levels of presence with the 3D HMD VR compared to 2D screen of (49.6 ± SD 8.9 versus 32.8 ± SD 11.1, mean 95% CI: 16.6, P < 0.0001). Increased perceived presence was associated with significantly lower pain intensity regardless of randomised sequencing of the two conditions (mean 95% CI: 0.06, P = 0.005). Effect size for pain reduction using 3D HMD VR was 0.80.
CONCLUSIONS


We suggest that 3D HMD VR may provide neuropathic pain relief for people with SCI. Given the lack of cybersickness and ease of access, we propose that immersive VR could be a helpful adjunct to current pharmacotherapy. Further research is required to show that VR can be effective for more long-term reductions in SCI pain.",2020,"Participants reported significantly higher perceived levels of presence with the 3D HMD VR compared to 2D screen of (49.6 ± SD 8.9 versus 32.8 ± SD 11.1, mean 95% CI: 16.6, P < 0.0001).","['people with spinal cord injury pain', 'people with SCI', 'Greenwich Hospital, Sydney, Australia', 'people with spinal cord injury (SCI', 'Sixteen men with established SCI and chronic neuropathic pain participated in a single-session randomised cross-over trial']","['head-mounted virtual-reality', '3D HMD VR and a 2D screen application', 'commercially available 3D head-mounted (HMD) virtual reality (VR) device', '3D HMD VR']","['neuropathic pain intensity', 'neuropathic pain relief', 'pain reduction using 3D HMD VR', 'SCI neuropathic pain intensity and levels of perceived presence', 'pain intensity', 'neuropathic pain']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C4544057', 'cui_str': 'Chronic neuropathic pain'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}]","[{'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0181909', 'cui_str': 'Mount'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0027796', 'cui_str': 'Neuralgia'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0181909', 'cui_str': 'Mount'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",16.0,0.2768,"Participants reported significantly higher perceived levels of presence with the 3D HMD VR compared to 2D screen of (49.6 ± SD 8.9 versus 32.8 ± SD 11.1, mean 95% CI: 16.6, P < 0.0001).","[{'ForeName': 'Philip D', 'Initials': 'PD', 'LastName': 'Austin', 'Affiliation': 'Department of Pain Management, HammondCare, Greenwich Hospital, Greenwich, Sydney, NSW, Australia. paustin@hammond.com.au.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Craig', 'Affiliation': 'John Walsh Centre for Rehabilitation Research, Northern Clinical School, Faculty of Medicine and Health, The University of Sydney, Kolling Institute, Royal North Shore Hospital, St Leonards, NSW, Australia.'}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Middleton', 'Affiliation': 'John Walsh Centre for Rehabilitation Research, Northern Clinical School, Faculty of Medicine and Health, The University of Sydney, Kolling Institute, Royal North Shore Hospital, St Leonards, NSW, Australia.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Tran', 'Affiliation': 'Centre of Healthcare Resilience and Implementation Science, Australian Institute of Health Innovation, Macquarie University, Sydney, NSW, Australia.'}, {'ForeName': 'Daniel S J', 'Initials': 'DSJ', 'LastName': 'Costa', 'Affiliation': 'Faculty of Medicine and Health, Pain Management Research Institute, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Wrigley', 'Affiliation': 'Faculty of Medicine and Health, Pain Management Research Institute, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Siddall', 'Affiliation': 'Department of Pain Management, HammondCare, Greenwich Hospital, Greenwich, Sydney, NSW, Australia.'}]",Spinal cord,['10.1038/s41393-020-00569-2']
1517,33078112,Subthreshold micropulse laser versus intravitreal anti-VEGF for diabetic macular edema patients with relatively better visual acuity.,"AIM


To compare the effects of yellow (577 nm) subthreshold micropulse laser (SML) and intravitreal (IV) anti-vascular endothelial growth factor (VEGF) treatment in patients with diabetic macular edema (DME) with relatively better visual acuity [best corrected visual acuity (BCVA) ≤0.15 logMAR].
METHODS


The medical records of 76 eyes of 47 patients underwent IV (0.5 mg) anti-VEGF injection or SML for the DME with relatively better BCVA were reviewed. The IV group received three consecutive monthly IV anti-VEGF injections, then were retreated as needed. The laser treatment group was treated at baseline and 3mo, and then retreated at 6 and 9mo if needed. All participants were followed up for one year. The mean BCVA and mean central macular thickness (CMT) values changes over the follow-up were evaluated.
RESULTS


Twenty-four and 23 patients were assigned to the SML and IV subgroups, respectively. The mean number of treatments was 3.64±0.76 in SML group and 5.85±1.38 in IV group ( P <0.05). The subgroups were similar with regard to the mean BCVA score at baseline and at the 1 st  and 3 rd  months, but the score of SML group was better than that of IV group at the 6 th , 9 th , and 12 th  months ( P <0.05). The decrease in the mean CMT values from baseline values was higher in SML group at the 6 th , 9 th , and 12 th  months ( P <0.05).
CONCLUSION


Yellow SML treatment is superior to IV anti-VEGF injection in DME patients with relatively better BCVA for increasing visual acuity and decreasing CMT at 6, 9, and 12mo. SML can be a good alternative first-line therapy for DME with BCVA ≤0.15 logMAR.",2020,"The subgroups were similar with regard to the mean BCVA score at baseline and at the 1 st  and 3 rd  months, but the score of SML group was better than that of IV group at the 6 th , 9 th , and 12 th  months ( P <0.05).","['patients with diabetic macular edema (DME) with relatively better visual acuity [best corrected visual acuity (BCVA) ≤0.15 logMAR', 'diabetic macular edema patients with relatively better visual acuity', 'Twenty-four and 23 patients', '76 eyes of 47 patients underwent']","['yellow (577 nm) subthreshold micropulse laser (SML) and intravitreal (IV) anti-vascular endothelial growth factor (VEGF) treatment', 'IV (0.5 mg) anti-VEGF injection or SML', 'SML', 'consecutive monthly IV anti-VEGF injections', 'Subthreshold micropulse laser versus intravitreal anti-VEGF']","['mean BCVA and mean central macular thickness (CMT) values', 'mean number of treatments', 'mean CMT values', 'mean BCVA score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0730285', 'cui_str': 'Macular edema due to diabetes mellitus'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}]","[{'cui': 'C0221205', 'cui_str': 'Yellow color'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",47.0,0.0224754,"The subgroups were similar with regard to the mean BCVA score at baseline and at the 1 st  and 3 rd  months, but the score of SML group was better than that of IV group at the 6 th , 9 th , and 12 th  months ( P <0.05).","[{'ForeName': 'Sezen', 'Initials': 'S', 'LastName': 'Akkaya', 'Affiliation': 'Departmant of Ophthalmology, Sağlık Bilimleri University, FSM Training and Research Hospital, İstanbul 34752, Turkey.'}, {'ForeName': 'Banu', 'Initials': 'B', 'LastName': 'Açıkalın', 'Affiliation': 'Departmant of Ophthalmology, Sağlık Bilimleri University, FSM Training and Research Hospital, İstanbul 34752, Turkey.'}, {'ForeName': 'Yusuf Emre', 'Initials': 'YE', 'LastName': 'Doğan', 'Affiliation': 'Departmant of Ophthalmology, Sağlık Bilimleri University, FSM Training and Research Hospital, İstanbul 34752, Turkey.'}, {'ForeName': 'Fatih', 'Initials': 'F', 'LastName': 'Çoban', 'Affiliation': 'Departmant of Ophthalmology, Sağlık Bilimleri University, FSM Training and Research Hospital, İstanbul 34752, Turkey.'}]",International journal of ophthalmology,['10.18240/ijo.2020.10.15']
1518,33078216,Passive Versus Active Intra-Abdominal Drainage Following Pancreaticoduodenectomy: A Retrospective Study Using The American College of Surgeons NSQIP Database.,"BACKGROUND


Prophylactic drainage following pancreaticoduodenectomy (PD) reduces morbidity and mortality. Little evidence exists to advise on whether passive gravity (PG) or active suction (AS) drainage systems result in superior outcomes. This study examines the relationship between drainage system and morbidity following PD.
METHODS


All patients undergoing elective PD with an operatively placed drain in the 2016 ACS-NSQIP database were included. Pre- and intra-operative factors were examined. Multivariable logistic regression and coarsened exact matching (CEM) were used to assess for an association between drainage system (PG vs. AS) and morbidity. The primary outcome was postoperative pancreatic fistula (POPF).
RESULTS


In total, 3430 patients were included: 563 (16.4%) with PG and 2867 (83.6%) with AS drainage system. On multivariable regression, 1787 patients were included. Drainage type was not associated with POPF, surgical site infection, delayed gastric emptying, or re-operation. AS drainage was protective against percutaneous drain insertion (OR 0.65, 95% CI 0.44-0.96, p = 0.033). In the CEM cohort (n = 268), superficial SSI was higher in the AS group (0.8% vs. 6.0%, p = 0.036). There was a trend toward higher rates of composite total SSI (PG 15.7%, AS 23.9%, p = 0.092) and organ space SSI (PG 14.2%, AS 20.2%, p = 0.195) in the AS group; this did not demonstrate statistical significance.
CONCLUSIONS


The findings of this study suggest that AS drainage is protective against percutaneous drain insertion, but may be associated with increased risk of SSI. There was no relation between drainage type and POPF. A prospective, randomized controlled trial is warranted to further explore these findings.",2020,"AS drainage was protective against percutaneous drain insertion (OR 0.65, 95% CI 0.44-0.96, p = 0.033).","['1787 patients were included', 'All patients undergoing elective PD with an operatively placed drain in the 2016 ACS-NSQIP database were included', '3430 patients were included: 563 (16.4%) with PG and 2867 (83.6%) with AS drainage system', 'American College of Surgeons NSQIP Database']","['Pancreaticoduodenectomy', 'pancreaticoduodenectomy (PD', 'passive gravity (PG) or active suction (AS) drainage systems', 'Passive Versus Active Intra-Abdominal Drainage']","['risk of SSI', 'superficial SSI', 'postoperative pancreatic fistula (POPF', 'POPF, surgical site infection, delayed gastric emptying, or re-operation', 'morbidity and mortality', 'rates of composite total SSI', 'organ space SSI', 'drainage type and POPF']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0085162', 'cui_str': 'Pancreaticoduodenectomy'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0013103', 'cui_str': 'Drainage procedure'}, {'cui': 'C0002455', 'cui_str': 'American Cancer Society'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0282189', 'cui_str': 'Gravity'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0038638', 'cui_str': 'Suction drainage'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}]","[{'cui': 'C0085162', 'cui_str': 'Pancreaticoduodenectomy'}, {'cui': 'C0282189', 'cui_str': 'Gravity'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0038638', 'cui_str': 'Suction drainage'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C1512911', 'cui_str': 'Intraabdominal route'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0030290', 'cui_str': 'Pancreatic fistula'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0152020', 'cui_str': 'Gastroparesis syndrome'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]",3430.0,0.286681,"AS drainage was protective against percutaneous drain insertion (OR 0.65, 95% CI 0.44-0.96, p = 0.033).","[{'ForeName': 'Madeline', 'Initials': 'M', 'LastName': 'Lemke', 'Affiliation': ""School of Medicine, Queen's University, Kingston, ON, Canada.""}, {'ForeName': 'Lily', 'Initials': 'L', 'LastName': 'Park', 'Affiliation': 'School of Medicine, University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'Fady K', 'Initials': 'FK', 'LastName': 'Balaa', 'Affiliation': 'School of Medicine, University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Martel', 'Affiliation': 'School of Medicine, University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'Jad Abou', 'Initials': 'JA', 'LastName': 'Khalil', 'Affiliation': 'School of Medicine, University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Bertens', 'Affiliation': 'School of Medicine, University of Ottawa, Ottawa, ON, Canada. kbertens@toh.ca.'}]",World journal of surgery,['10.1007/s00268-020-05823-5']
1519,33078318,"Reducing Seroma Formation and Its Sequelae After Mastectomy by Closure of the Dead Space: A Multi-center, Double-Blind Randomized Controlled Trial (SAM-Trial).","BACKGROUND


Seroma is a common complication after mastectomy, with an incidence of 3% to 85%. Seroma is associated with pain, delayed wound healing, and additional outpatient clinic visits, leading potentially to repeated seroma aspiration or even surgical interventions. This study aimed to assess the effect of flap fixation using sutures or tissue glue in preventing seroma formation and its sequelae.
METHODS


Between June 2014 and July 2018, 339 patients with an indication for mastectomy or modified radical mastectomy were enrolled in this randomized controlled trial in the Netherlands. Patients were randomly allocated to one of the three following arms: conventional wound closure (CON, n = 115), flap fixation using sutures (FFS, n = 111) or flap fixation using tissue glue (FFG, n = 113). The primary outcome was the need for seroma aspiration. The secondary outcomes were additional outpatient department visits, surgical-site infection, shoulder function and mobility, cosmesis, skin-dimpling, and postoperative pain scores.
RESULTS


Flap fixation after mastectomy leads to fewer seroma aspirations than conventional wound closure (CON 17.5% vs FFS 7.3% vs FFG 10.8%; p = 0.057), with a significant difference between flap fixation with sutures and conventional wound closure (odds ratio [OR], 0.37; 95% confidence interval [CI], 0.16-0.89; p = 0.025). Flap fixation has no significant negative effect on surgical-site infections, shoulder function and mobility, cosmesis, skin-dimpling, or postoperative pain.
CONCLUSION


Flap fixation using sutures leads to a significant reduction in aspirations of post-mastectomy seromas. The authors strongly advise surgeons to use sutures for flap fixation in patients undergoing mastectomy. (ClinicalTrials.gov no. NCT03305757).
PREREGISTRATION


The trial was registered after enrollment of the first participant. However, no specific explanation exists for this except that through the years more importance has been given to central trial registration. Our research team can ensure that after enrollment of the first participant, no changes were made to the trial, analysis plan, and/or study design.",2020,"Flap fixation has no significant negative effect on surgical-site infections, shoulder function and mobility, cosmesis, skin-dimpling, or postoperative pain.
","['Between June 2014 and July 2018', 'patients undergoing mastectomy', '339 patients with an indication for mastectomy or modified radical mastectomy']","['flap fixation using sutures or tissue glue', 'conventional wound closure (CON, n\u2009=\u2009115), flap fixation using sutures (FFS, n\u2009=\u2009111) or flap fixation using tissue glue (FFG, n\u2009=\u2009113', 'Flap fixation']","['seroma aspirations', 'pain, delayed wound healing, and additional outpatient clinic visits', 'flap fixation with sutures and conventional wound closure', 'need for seroma aspiration', 'surgical-site infections, shoulder function and mobility, cosmesis, skin-dimpling, or postoperative pain', 'Seroma Formation and Its Sequelae', 'additional outpatient department visits, surgical-site infection, shoulder function and mobility, cosmesis, skin-dimpling, and postoperative pain scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024881', 'cui_str': 'Mastectomy'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0024883', 'cui_str': 'Modified radical mastectomy'}]","[{'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0017780', 'cui_str': 'Glue'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0450015', 'cui_str': 'Method of wound closure'}, {'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C4517538', 'cui_str': '111'}]","[{'cui': 'C0262627', 'cui_str': 'Seroma'}, {'cui': 'C0004056', 'cui_str': 'Aspiration, Psychology'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0151692', 'cui_str': 'Impaired wound healing'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0450015', 'cui_str': 'Method of wound closure'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0243088', 'cui_str': 'sequels'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",339.0,0.27414,"Flap fixation has no significant negative effect on surgical-site infections, shoulder function and mobility, cosmesis, skin-dimpling, or postoperative pain.
","[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'de Rooij', 'Affiliation': 'Department of Surgery, Zuyderland Medical Center, Sittard, The Netherlands. l.derooij@zuyderland.nl.'}, {'ForeName': 'S M J', 'Initials': 'SMJ', 'LastName': 'van Kuijk', 'Affiliation': 'Department of Clinical Epidemiology and Medical Technology Assessment, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'R W Y', 'Initials': 'RWY', 'LastName': 'Granzier', 'Affiliation': 'Department of Surgery, Zuyderland Medical Center, Sittard, The Netherlands.'}, {'ForeName': 'K F H', 'Initials': 'KFH', 'LastName': 'Hintzen', 'Affiliation': 'Department of Surgery, Zuyderland Medical Center, Sittard, The Netherlands.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Heymans', 'Affiliation': 'Department of Surgery, Zuyderland Medical Center, Sittard, The Netherlands.'}, {'ForeName': 'L L B', 'Initials': 'LLB', 'LastName': 'Theunissen', 'Affiliation': 'Department of Surgery, Zuyderland Medical Center, Sittard, The Netherlands.'}, {'ForeName': 'E M', 'Initials': 'EM', 'LastName': 'von Meyenfeldt', 'Affiliation': 'Department of Surgery, Albert Schweitzer Hospital, Dordrecht, The Netherlands.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'van Essen', 'Affiliation': 'Department of Surgery, St. Jans Gasthuis Hospital, Weert, The Netherlands.'}, {'ForeName': 'E R M', 'Initials': 'ERM', 'LastName': 'van Haaren', 'Affiliation': 'Department of Surgery, Zuyderland Medical Center, Sittard, The Netherlands.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Janssen', 'Affiliation': 'Department of Surgery, Zuyderland Medical Center, Sittard, The Netherlands.'}, {'ForeName': 'Y L J', 'Initials': 'YLJ', 'LastName': 'Vissers', 'Affiliation': 'Department of Surgery, Zuyderland Medical Center, Sittard, The Netherlands.'}, {'ForeName': 'G L', 'Initials': 'GL', 'LastName': 'Beets', 'Affiliation': 'Department of Surgery, Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'van Bastelaar', 'Affiliation': 'Department of Surgery, Zuyderland Medical Center, Sittard, The Netherlands.'}]",Annals of surgical oncology,['10.1245/s10434-020-09225-8']
1520,33078322,Effectiveness of Menghini-Type Needles for Endoscopic Ultrasound-Guided Fine-Needle Aspiration of Pancreatic Masses.,"BACKGROUND


Cutting needles are thought to be effective as biopsy needles. A few types of cutting needles are available for endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA), and the Menghini-type needle is an end-type cutting needle.
AIMS


A prospective randomized controlled trial was conducted to compare the results of EUS-FNA using a Menghini-type needle (needle M) versus a conventional needle (needle S).
METHODS


The main eligibility criteria were as follows: patients with a pancreatic mass referred for EUS-FNA, ≥ 20 years old, and a performance status < 4. The primary outcome was the sample quality. The secondary outcomes were factors associated with the sample quality, diagnostic accuracy, and adverse events.
RESULTS


A total of 97 patients were enrolled in this study. The sample quality for total puncture with needle M (92.8%) was significantly higher than that with needle S (81.4%) (p = 0.0305). The tumor size (p = 0.033) and type of needle (p = 0.031) were significant factors associated with adequate tissue collection in univariate and multivariate analyses (odds ratio [OR] 2.71; 95% confidence interval [CI] 1.12-6.54; p = 0.027 for tumor size, and OR 2.93; 95% CI 1.23-8.21; p = 0.0153 for type of needle). The diagnostic accuracy of each needle was 88.7% (86/97) with needle M and 73.2% (71/97) with needle S. Adverse events occurred in 2 of the 97 patients (0.02%).
CONCLUSION


A Menghini-type needle was able to obtain core tissue for histology more effectively than a conventional aspiration needle.
TRIAL REGISTRATION NUMBERS


UMIN registration number of 000020668.",2020,The tumor size (p = 0.033) and type of needle (p = 0.031) were significant factors associated with adequate tissue collection in univariate and multivariate analyses (odds ratio [OR] 2.71; 95% confidence interval [CI] 1.12-6.54;,"['97 patients were enrolled in this study', 'The main eligibility criteria were as follows: patients with a pancreatic mass referred for EUS-FNA, ≥', '20\xa0years old, and a performance status\u2009<\u20094']","['Menghini-type needle (needle M', 'conventional needle (needle S', 'EUS-FNA', 'Menghini-Type Needles', 'Menghini-type needle']","['sample quality, diagnostic accuracy, and adverse events', 'sample quality for total puncture with needle M', 'diagnostic accuracy of each needle', 'needle S. Adverse events', 'sample quality', 'tumor size']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0877425', 'cui_str': 'Mass of pancreas'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C1880510', 'cui_str': 'EUS-FNA'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0449438', 'cui_str': 'Status'}]","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C1880510', 'cui_str': 'EUS-FNA'}]","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0475440', 'cui_str': 'Tumor size'}]",97.0,0.0416438,The tumor size (p = 0.033) and type of needle (p = 0.031) were significant factors associated with adequate tissue collection in univariate and multivariate analyses (odds ratio [OR] 2.71; 95% confidence interval [CI] 1.12-6.54;,"[{'ForeName': 'Sho', 'Initials': 'S', 'LastName': 'Mizukawa', 'Affiliation': 'Department of Gastroenterology and Hepatology, Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama University, 2-5-1 Shikata-cho, Kita-ku, Okayama, 700-8558, Japan.'}, {'ForeName': 'Hironari', 'Initials': 'H', 'LastName': 'Kato', 'Affiliation': 'Department of Gastroenterology and Hepatology, Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama University, 2-5-1 Shikata-cho, Kita-ku, Okayama, 700-8558, Japan. katou-h@cc.okayama-u.ac.jp.'}, {'ForeName': 'Kazuyuki', 'Initials': 'K', 'LastName': 'Matsumoto', 'Affiliation': 'Department of Gastroenterology and Hepatology, Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama University, 2-5-1 Shikata-cho, Kita-ku, Okayama, 700-8558, Japan.'}, {'ForeName': 'Shinichiro', 'Initials': 'S', 'LastName': 'Muro', 'Affiliation': 'Department of Gastroenterology and Hepatology, Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama University, 2-5-1 Shikata-cho, Kita-ku, Okayama, 700-8558, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Akimoto', 'Affiliation': 'Department of Gastroenterology and Hepatology, Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama University, 2-5-1 Shikata-cho, Kita-ku, Okayama, 700-8558, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Uchida', 'Affiliation': 'Department of Gastroenterology and Hepatology, Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama University, 2-5-1 Shikata-cho, Kita-ku, Okayama, 700-8558, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Tomoda', 'Affiliation': 'Department of Gastroenterology and Hepatology, Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama University, 2-5-1 Shikata-cho, Kita-ku, Okayama, 700-8558, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Gastroenterology and Hepatology, Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama University, 2-5-1 Shikata-cho, Kita-ku, Okayama, 700-8558, Japan.'}, {'ForeName': 'Shigeru', 'Initials': 'S', 'LastName': 'Horiguchi', 'Affiliation': 'Department of Gastroenterology and Hepatology, Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama University, 2-5-1 Shikata-cho, Kita-ku, Okayama, 700-8558, Japan.'}, {'ForeName': 'Koichiro', 'Initials': 'K', 'LastName': 'Tsutsumi', 'Affiliation': 'Department of Gastroenterology and Hepatology, Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama University, 2-5-1 Shikata-cho, Kita-ku, Okayama, 700-8558, Japan.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Inoue', 'Affiliation': 'Department of Diagnostic Pathology, Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama University, Okayama, Japan.'}, {'ForeName': 'Noriyuki', 'Initials': 'N', 'LastName': 'Tanaka', 'Affiliation': 'Department of Diagnostic Pathology, Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama University, Okayama, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Okada', 'Affiliation': 'Department of Gastroenterology and Hepatology, Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama University, 2-5-1 Shikata-cho, Kita-ku, Okayama, 700-8558, Japan.'}]",Digestive diseases and sciences,['10.1007/s10620-020-06628-1']
1521,33078386,Fenfluramine HCl (Fintepla ®  ) provides long-term clinically meaningful reduction in seizure frequency: Analysis of an ongoing open-label extension study.,"OBJECTIVE


Fenfluramine has been shown to provide clinically meaningful and statistically significant reductions in convulsive seizure frequency in children and adolescents (aged 2-18 years) with Dravet syndrome in two randomized, placebo-controlled clinical trials. The objective of this analysis was to assess longer-term safety and efficacy of fenfluramine in patients who completed one of the double-blind studies and entered an open-label extension (OLE) study.
METHODS


Patients enrolling in the OLE study initiated fenfluramine at 0.2 mg/kg/d regardless of their treatment assignment in the double-blind study. After 4 weeks, the fenfluramine dose could be titrated based on efficacy and tolerability to maximum of 0.7 mg/kg/d (absolute maximum 27 mg/d) or maximum of 0.4 mg/kg/d (absolute maximum 17 mg/d) in patients receiving concomitant stiripentol. The number and type of seizures were recorded daily in an electronic diary, and safety, including echocardiography, was assessed at Months 1, 2, and 3, and at 3-month intervals thereafter.
RESULTS


A total of 232 patients were enrolled as of March 13, 2018. During this analysis period, patients were treated for a median 256 days (range = 46-634 days). Over the entire OLE analysis period, the median decrease in convulsive seizure frequency compared to baseline in the double-blind studies was -66.8% (range = -100% to 234.9%; P < .001). The median reduction in seizure frequency was similar in patients <6 (-75.7%) and ≥6 years old (-64.7%). The most commonly reported adverse events included pyrexia (21.6%), nasopharyngitis (19.4%), and decreased appetite (-15.9%). No valvular heart disease (VHD) or pulmonary arterial hypertension (PAH) was observed.
SIGNIFICANCE


Study results demonstrate that fenfluramine provides clinically meaningful (≥50%) seizure frequency reduction over an extended period in patients with Dravet syndrome. No patient developed VHD or PAH, and fenfluramine was generally well tolerated.",2020,The median reduction in seizure frequency was similar in patients <6 (-75.7%) and ≥6 years old (-64.7%).,"['232 patients were enrolled as of March 13, 2018', 'children and adolescents (aged 2-18\xa0years) with Dravet syndrome', 'patients with Dravet syndrome', 'Patients enrolling in the OLE study initiated', 'seizure frequency', 'patients who completed one of the double-blind studies and entered an open-label extension (OLE) study']","['Fenfluramine', 'fenfluramine', 'placebo', 'Fenfluramine HCl (Fintepla ®  ', 'concomitant stiripentol']","['median reduction in seizure frequency', 'convulsive seizure frequency', 'longer-term safety and efficacy', 'appetite', 'tolerated', 'number and type of seizures', 'pyrexia', 'VHD or PAH', 'valvular heart disease (VHD) or pulmonary arterial hypertension (PAH', 'efficacy and tolerability', 'nasopharyngitis']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0751122', 'cui_str': 'Severe myoclonic epilepsy in infancy'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0149775', 'cui_str': 'Fit frequency'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}]","[{'cui': 'C0011786', 'cui_str': 'Dexfenfluramine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0282179', 'cui_str': 'Fenfluramine hydrochloride'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0075262', 'cui_str': 'stiripentol'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0149775', 'cui_str': 'Fit frequency'}, {'cui': 'C0751494', 'cui_str': 'Seizures, Convulsive'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0030123', 'cui_str': '4-Aminohippuric Acid'}, {'cui': 'C0018824', 'cui_str': 'Heart valve disorder'}, {'cui': 'C2973725', 'cui_str': 'Pulmonary arterial hypertension'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}]",232.0,0.545272,The median reduction in seizure frequency was similar in patients <6 (-75.7%) and ≥6 years old (-64.7%).,"[{'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Sullivan', 'Affiliation': ""Benioff Children's Hospital, University of California San Francisco, San Francisco, CA, USA.""}, {'ForeName': 'Ingrid E', 'Initials': 'IE', 'LastName': 'Scheffer', 'Affiliation': ""Austin Health and Royal Children's Hospital, University of Melbourne, Melbourne, VIC, Australia.""}, {'ForeName': 'Lieven', 'Initials': 'L', 'LastName': 'Lagae', 'Affiliation': 'Department of Paediatric Neurology, University of Leuven, Leuven, Belgium.'}, {'ForeName': 'Rima', 'Initials': 'R', 'LastName': 'Nabbout', 'Affiliation': 'Service de Neurologie Pédiatrique Centre de Référence Épilepsies Rares (CReER), Hôpital Universitaire Necker - Enfants Malades, Paris, France.'}, {'ForeName': 'Milka', 'Initials': 'M', 'LastName': 'Pringsheim', 'Affiliation': 'Department of Pediatric Cardiology, German Heart Centre Munich, Munich, Germany.'}, {'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Talwar', 'Affiliation': 'Center for Neurosciences, University of Arizona Health Sciences Center, Tucson, AZ, USA.'}, {'ForeName': 'Tilman', 'Initials': 'T', 'LastName': 'Polster', 'Affiliation': 'Department of Pediatric Epileptology, Bethel Epilepsy Center, Mara Hospital, Bielefeld, Germany.'}, {'ForeName': 'Bradley', 'Initials': 'B', 'LastName': 'Galer', 'Affiliation': 'Zogenix, Inc, Emeryville, CA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Lock', 'Affiliation': 'Zogenix, Inc, Emeryville, CA, USA.'}, {'ForeName': 'Anupam', 'Initials': 'A', 'LastName': 'Agarwal', 'Affiliation': 'Zogenix, Inc, Emeryville, CA, USA.'}, {'ForeName': 'Arnold', 'Initials': 'A', 'LastName': 'Gammaitoni', 'Affiliation': 'Zogenix, Inc, Emeryville, CA, USA.'}, {'ForeName': 'Glenn', 'Initials': 'G', 'LastName': 'Morrison', 'Affiliation': 'Zogenix, Inc, Emeryville, CA, USA.'}, {'ForeName': 'Gail', 'Initials': 'G', 'LastName': 'Farfel', 'Affiliation': 'Zogenix, Inc, Emeryville, CA, USA.'}]",Epilepsia,['10.1111/epi.16722']
1522,33078435,The effect of daily aerobic cycling exercise on sleep quality during inpatient cannabis withdrawal: A randomised controlled trial.,"Sleep disturbance is a common symptom encountered by cannabis-dependent individuals abstaining from cannabis use. In the present study, we investigated the effect of daily aerobic cycling exercise versus control stretching on sleep quality during inpatient cannabis withdrawal in treatment-seeking dependent cannabis users. The protocol incorporated three consecutive phases: a 4-Day (4-Night) (at-home) 'Baseline' phase, a 6-Day (5-Night) 'Treatment' phase (within a 7-Day inpatient hospital stay) and a 3-Day (4-Night) (at-home) 'Post-Treatment' phase. Participants performed 35 min of monitored activity per day during the Treatment phase. The intervention group (n = 19) cycled at ~60% aerobic capacity (VO 2max  ), while the control group (n = 12) performed a stretching routine. Objective sleep quality was measured nightly throughout the study using wrist actiography; ratings of subjective sleep quality were also recorded during the Treatment phase. There were no group differences in sleep measures during the Baseline phase (all p > .05). Objective sleep onset latency increased from the Baseline to the Treatment phase in the control (stretching) group (p = .042). In contrast, the Cycling group exhibited improvements in sleep duration (p = .008) and sleep efficiency (p = .023) during the Treatment phase compared to the Baseline phase. Cycling also increased sleep duration (p = .005), decreased average wake bout (p = .040) and tended to increase sleep efficiency (p = .051) compared to stretching during the Treatment phase. Subjective sleep quality ratings did not differ between groups (p > .10). These preliminary findings suggest that moderate-intensity aerobic exercise may attenuate the sleep disturbances associated with cannabis withdrawal.",2020,"Cycling also increased sleep duration (p = .005), decreased average wake bout (p = .040) and tended to increase sleep efficiency (p = .051) compared to stretching during the Treatment phase.","['inpatient cannabis withdrawal in treatment-seeking dependent cannabis users', 'inpatient cannabis withdrawal']","['daily aerobic cycling exercise versus control stretching', 'intervention group (n\xa0=\xa019) cycled at ~60% aerobic capacity (VO 2max  ), while the control group (n\xa0=\xa012) performed a stretching routine', 'daily aerobic cycling exercise']","['sleep efficiency', 'Subjective sleep quality ratings', 'subjective sleep quality', 'average wake bout', 'sleep measures', 'sleep duration', 'sleep disturbances', 'Sleep disturbance', 'Objective sleep onset latency', 'sleep quality', 'Objective sleep quality']","[{'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C3840212', 'cui_str': 'Cannabis withdrawal'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}]",,0.0265146,"Cycling also increased sleep duration (p = .005), decreased average wake bout (p = .040) and tended to increase sleep efficiency (p = .051) compared to stretching during the Treatment phase.","[{'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'McCartney', 'Affiliation': 'Lambert Initiative for Cannabinoid Therapeutics, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Ashling D', 'Initials': 'AD', 'LastName': 'Isik', 'Affiliation': 'Lambert Initiative for Cannabinoid Therapeutics, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Kieron', 'Initials': 'K', 'LastName': 'Rooney', 'Affiliation': 'Faculty of Medicine and Health, Discipline of Exercise and Sport Science, Charles Perkins Centre, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Jonathon C', 'Initials': 'JC', 'LastName': 'Arnold', 'Affiliation': 'Lambert Initiative for Cannabinoid Therapeutics, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Delwyn J', 'Initials': 'DJ', 'LastName': 'Bartlett', 'Affiliation': 'Woolcock Institute of Medical Research, Glebe, NSW, Australia.'}, {'ForeName': 'Bridin', 'Initials': 'B', 'LastName': 'Murnion', 'Affiliation': 'Drug and Alcohol Services, Central Coast Local Health District, Gosford, NSW, Australia.'}, {'ForeName': 'Elisha', 'Initials': 'E', 'LastName': 'Richards', 'Affiliation': 'Lambert Initiative for Cannabinoid Therapeutics, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Arkell', 'Affiliation': 'Lambert Initiative for Cannabinoid Therapeutics, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Lintzeris', 'Affiliation': 'Faculty of Medicine and Health, Discipline of Addiction Medicine, Central Clinical School, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Iain S', 'Initials': 'IS', 'LastName': 'McGregor', 'Affiliation': 'Lambert Initiative for Cannabinoid Therapeutics, University of Sydney, Sydney, NSW, Australia.'}]",Journal of sleep research,['10.1111/jsr.13211']
1523,33078447,"Use as directed: do standard drink labels on alcohol containers help consumers drink (ir)responsibly? Real-world evidence from a quasi-experimental study in Yukon, Canada.","INTRODUCTION AND AIMS


This paper examines the impact of an alcohol labelling intervention on recall of and support for standard drink (SD) labels, estimating the number of SDs in alcohol containers, and intended and unintended use of SD labels.
DESIGN AND METHODS


A quasi-experimental study was conducted in Canada where labels with a cancer warning, national drinking guidelines and SD information were applied to alcohol containers in the single liquor store in the intervention site, while usual labelling continued in the two liquor stores in the comparison site. Three waves of surveys were conducted in both sites before and at two time-points after the intervention with 2049 cohort participants. Generalised estimating equations were applied to estimate changes in all outcomes.
RESULTS


Participants in the intervention relative to the comparison site had greater odds of recalling [adjusted odds ratio (AOR) 5.69, 95% confidence interval (CI) 3.02, 10.71] and supporting SD labels (AOR 1.49, 95% CI 1.04, 2.12) and lower odds of reporting using SD labels to purchase high strength, low-cost alcohol (AOR 0.65, 95% CI 0.45, 0.93). Exposure to the labels had negligible effects on accurately estimating the number of SDs (AOR 1.06, 95% CI 0.59, 1.93) and using SD labels to drink within guidelines (AOR 1.04, 95% CI 0.75, 1.46).
DISCUSSION AND CONCLUSIONS


Evidence-informed labels increased support for and decreased unintended use of SD labels. Such labels can improve accuracy in estimating the number of SDs in alcohol containers and adherence to drinking guidelines.",2020,"Exposure to the labels had negligible effects on accurately estimating the number of SDs (AOR 1.06, 95% CI 0.59, 1.93) and using SD labels to drink within guidelines (AOR 1.04, 95% CI 0.75, 1.46).
","['A quasi-experimental study was conducted in Canada where labels with a cancer warning, national drinking guidelines and SD information']",['alcohol labelling intervention'],"['SD labels', 'number of SDs']","[{'cui': 'C2985410', 'cui_str': 'Controlled Clinical Trials, Non-Randomized'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0452428', 'cui_str': 'Drink'}]","[{'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0037506', 'cui_str': 'Sodium lauryl sulfate'}]",,0.0546647,"Exposure to the labels had negligible effects on accurately estimating the number of SDs (AOR 1.06, 95% CI 0.59, 1.93) and using SD labels to drink within guidelines (AOR 1.04, 95% CI 0.75, 1.46).
","[{'ForeName': 'Nour', 'Initials': 'N', 'LastName': 'Schoueri-Mychasiw', 'Affiliation': 'Health Promotion, Chronic Disease and Injury Prevention, Public Health Ontario, Toronto, Canada.'}, {'ForeName': 'Ashini', 'Initials': 'A', 'LastName': 'Weerasinghe', 'Affiliation': 'Health Promotion, Chronic Disease and Injury Prevention, Public Health Ontario, Toronto, Canada.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Stockwell', 'Affiliation': 'Canadian Institute for Substance Use Research, University of Victoria, Victoria, Canada.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Vallance', 'Affiliation': 'Canadian Institute for Substance Use Research, University of Victoria, Victoria, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hammond', 'Affiliation': 'School of Public Health and Health Systems, University of Waterloo, Waterloo, Canada.'}, {'ForeName': 'Thomas K', 'Initials': 'TK', 'LastName': 'Greenfield', 'Affiliation': 'Alcohol Research Group, Public Health Institute, Emeryville, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'McGavock', 'Affiliation': ""Children's Hospital Research Institute of Manitoba, University of Manitoba, Winnipeg, Canada.""}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Hobin', 'Affiliation': 'Health Promotion, Chronic Disease and Injury Prevention, Public Health Ontario, Toronto, Canada.'}]",Drug and alcohol review,['10.1111/dar.13165']
1524,33078467,The Impact of Hazardous Drinking Among Active Duty Military With Posttraumatic Stress Disorder: Does Cognitive Processing Therapy Format Matter?,"This study was a secondary data analysis of clinical trial data collected from 268 active duty U.S. military service members seeking cognitive processing therapy (CPT) for posttraumatic stress disorder (PTSD) at Fort Hood, Texas, related to combat operations following September 11, 2001. Our primary aim was to evaluate changes in PTSD symptom severity and alcohol misuse as a function of baseline hazardous drinking and treatment format (i.e., group or individual). At baseline and posttreatment, PTSD was assessed using the PTSD Symptom Scale-Interview Version and PTSD Checklist for DSM-5. Hazardous drinking was categorically defined as an Alcohol Use Disorder Identification Test total score of 8 or higher. Employing intent-to-treat, mixed-effects regression analysis, all groups reported reduced PTSD symptom severity, Hedges' gs = -0.33 to -1.01, except, unexpectedly, nonhazardous drinkers who were randomized to group CPT, Hedges' g = -0.12. Hazardous drinkers who were randomized to individual therapy had larger reductions in PTSD symptoms than nonhazardous drinkers who were randomized to group CPT, Hedges' g = -0.25. Hazardous drinkers also reported significant reductions in alcohol misuse, regardless of treatment format, Hedges' gs = -0.78 to -0.86. This study builds upon an emerging literature suggesting that individuals with PTSD and co-occurring alcohol use disorder can engage successfully in CPT, which appears to be an appropriate treatment for these individuals whether it is delivered individually or in a group format. However, as a portion of participants remained classified as hazardous drinkers at posttreatment, some individuals may benefit from integrated treatment.",2020,"Hazardous drinkers who were randomized to individual therapy had larger reductions in PTSD symptoms than nonhazardous drinkers who were randomized to group CPT, Hedges' g = -0.25.","['individuals with PTSD and co-occurring alcohol use disorder', '268 active duty U.S. military service members seeking cognitive processing therapy (CPT) for posttraumatic stress disorder (PTSD) at Fort Hood, Texas, related to combat operations following September 11, 2001', 'Active Duty Military With Posttraumatic Stress Disorder', 'Hazardous drinkers']",['Hazardous Drinking'],"['PTSD symptoms', 'PTSD Symptom Scale-Interview Version and PTSD Checklist for DSM-5']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C4517673', 'cui_str': '268'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0336524', 'cui_str': 'Military services member'}, {'cui': 'C0025361', 'cui_str': 'Form of thinking'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0039711', 'cui_str': 'Texas'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C3831794', 'cui_str': 'Active duty military'}]","[{'cui': 'C0001948', 'cui_str': 'Alcohol intake'}]","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}]",,0.0178156,"Hazardous drinkers who were randomized to individual therapy had larger reductions in PTSD symptoms than nonhazardous drinkers who were randomized to group CPT, Hedges' g = -0.25.","[{'ForeName': 'Casey L', 'Initials': 'CL', 'LastName': 'Straud', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center at San Antonio, San Antonio, Texas, USA.'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Dondanville', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center at San Antonio, San Antonio, Texas, USA.'}, {'ForeName': 'Willie J', 'Initials': 'WJ', 'LastName': 'Hale', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center at San Antonio, San Antonio, Texas, USA.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Wachen', 'Affiliation': ""Women's Health Sciences Division, National Center for PTSD, VA Boston Healthcare System, Boston, Massachusetts, USA.""}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Mintz', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center at San Antonio, San Antonio, Texas, USA.'}, {'ForeName': 'Brett T', 'Initials': 'BT', 'LastName': 'Litz', 'Affiliation': 'Department of Psychiatry, Boston University School of Medicine, Boston, Massachusetts, USA.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Roache', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center at San Antonio, San Antonio, Texas, USA.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Yarvis', 'Affiliation': 'Department of Behavioral Health, Carl R. Darnall Army Medical Center, Fort Hood, Texas, USA.'}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Young-McCaughan', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center at San Antonio, San Antonio, Texas, USA.'}, {'ForeName': 'Alan L', 'Initials': 'AL', 'LastName': 'Peterson', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center at San Antonio, San Antonio, Texas, USA.'}, {'ForeName': 'Patricia A', 'Initials': 'PA', 'LastName': 'Resick', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University, Durham, North Carolina, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of traumatic stress,['10.1002/jts.22609']
1525,33078479,Prescription Medication Use in Older Adults Without Major Cardiovascular Disease Enrolled in the Aspirin in Reducing Events in the Elderly (ASPREE) Clinical Trial.,"BACKGROUND


Efforts to minimize medication risks among older adults include avoidance of potentially inappropriate medications. Contemporary analysis of medication use in community-dwelling older people compared with the general population is lacking.
PARTICIPANTS


A total of 19,114 community-dwelling adults in Australia and the United States aged 70 years or older (65 years or older for U.S. minorities) without histories of major cardiovascular disease, cognitive impairment, or disability participated in a randomized, placebo-controlled trial of aspirin: ASPirin in Reducing Events in the Elderly study. Measurements Prescribed baseline medications obtained by self-report and medical record review were grouped by World Health Organization Anatomic and Therapeutic Chemical category. Potentially inappropriate medications were defined using a modified American Geriatrics Society Beers Criteria. Polypharmacy was defined as 5 or more medications, and hyperpolypharmacy defined as 10 or more medications. Cross-sectional descriptive statistics and adjusted odds ratios were computed.
RESULTS


The median number of prescription medications per participant was three, regardless of age. Women had a higher medication prevalence. Cardiovascular drugs (primarily antihypertensives) were the most commonly reported (64%). Overall, 39% of the cohort reported taking at least one potentially inappropriate medication, with proton-pump inhibitors being the most commonly reported (21.2% of cohort). Of the cohort, 27% had polypharmacy, and 2% hyperpolypharmacy. Age 75 years or older, less than 12 years of education, hypertension, diabetes mellitus, chronic kidney disease, frailty, gastrointestinal complaint, and depressive symptoms were associated with an increased likelihood of potentially inappropriate medications and polypharmacy. For almost all medication classes, prevalence was equivalent or lower than the general older population.
CONCLUSION


Overall medication burden and polypharmacy are low in older adults free of major cardiovascular disease, disability, and cognitive impairment. The prevalence of potentially inappropriate medications is higher than previously reported and similar to more vulnerable populations as a result of the introduction of proton-pump inhibitors to the American Geriatrics Society Beers Criteria. Longitudinal follow-up is required to further understand the balance of benefits and risks for potentially inappropriate medications and polypharmacy in community-dwelling older people.",2020,Women had a higher medication prevalence.,"['older adults', 'A total of 19,114 community-dwelling adults in Australia and the United States aged 70\xa0years or older (65 years or older for U.S. minorities) without histories of major cardiovascular disease, cognitive impairment, or disability participated in a randomized', 'community-dwelling older people', 'Age\xa075\xa0years or older, less than 12\xa0years of education, hypertension, diabetes mellitus, chronic kidney disease, frailty, gastrointestinal complaint, and depressive symptoms were associated with an increased likelihood of potentially inappropriate medications and polypharmacy', 'Older Adults Without Major Cardiovascular Disease']","['Aspirin', 'placebo', 'aspirin: ASPirin']","['Elderly (ASPREE', 'median number of prescription medications']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C4042848', 'cui_str': 'PIM List'}, {'cui': 'C2922974', 'cui_str': 'Polypharmacy'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",19114.0,0.072949,Women had a higher medication prevalence.,"[{'ForeName': 'Jessica E', 'Initials': 'JE', 'LastName': 'Lockery', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Ernst', 'Affiliation': 'Department of Pharmacy Practice and Science, College of Pharmacy and Department of Family Medicine, Carver College of Medicine, The University of Iowa, Iowa City, Iowa, USA.'}, {'ForeName': 'Jonathan C', 'Initials': 'JC', 'LastName': 'Broder', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Suzanne G', 'Initials': 'SG', 'LastName': 'Orchard', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Murray', 'Affiliation': 'Hennepin Healthcare Research Institute, Hennepin Healthcare, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Nelson', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Hobart, Tasmania, Australia.'}, {'ForeName': 'Nigel P', 'Initials': 'NP', 'LastName': 'Stocks', 'Affiliation': 'Discipline of General Practice, University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Rory', 'Initials': 'R', 'LastName': 'Wolfe', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Reid', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'Liew', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Robyn L', 'Initials': 'RL', 'LastName': 'Woods', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Pharmacotherapy,['10.1002/phar.2461']
1526,33078480,"The effect of crocin (the main active saffron constituent) on the cognitive functions, craving, and withdrawal syndrome in opioid patients under methadone maintenance treatment.","Individuals under methadone maintenance treatment (MMT) programs are susceptible to several complications, including withdrawal syndrome, craving, and cognitive deficits. This study was designed to elevate the effect of crocin administration on withdrawal syndrome, craving, and cognitive function in subjects under MMT programs. It was a clinical trial that was conducted among 60 patients referred to Soltan Mirahmad Clinic for addict patients in Kashan, Iran. The patients were allocated to two groups including placebo and intervention groups. The intervention group received 30 mg/day crocin (n = 30) and placebo (n = 30) once a day, in 12 weeks. Withdrawal syndrome, craving, and cognitive function parameters were measured before and after the intervention in subjects under MMT programs. Compared with the placebo group, crocin resulted in a significant improvement in craving score (p = .03), and withdrawal symptoms score (p = .01) in the intervention group. In addition, crocin supplementation did not affect cognitive function parameters (e.g., TMT, FAS test, and DGSP score). Overall, crocin supplementation for 12 weeks to patients under MMT programs had beneficial effects on craving and withdrawal symptoms score, but did not affect the cognitive function parameters.",2020,"Compared with the placebo group, crocin resulted in a significant improvement in craving score (p = .03), and withdrawal symptoms score (p = .01) in the intervention group.","['Individuals under', 'subjects under MMT programs', '60 patients referred to Soltan Mirahmad Clinic for addict patients in Kashan, Iran', 'opioid patients under methadone maintenance treatment']","['crocin supplementation', 'methadone maintenance treatment (MMT) programs', '30\u2009mg/day crocin', 'crocin', 'placebo']","['cognitive function parameters', 'withdrawal syndrome, craving, and cognitive function', 'craving and withdrawal symptoms score', 'Withdrawal syndrome, craving, and cognitive function parameters', 'cognitive function parameters (e.g., TMT, FAS test, and DGSP score', 'withdrawal symptoms score', 'cognitive functions, craving, and withdrawal syndrome', 'craving score']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0588202', 'cui_str': 'Drug addiction therapy - methadone'}]","[{'cui': 'C0056503', 'cui_str': 'crocin'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0588202', 'cui_str': 'Drug addiction therapy - methadone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0038587', 'cui_str': 'Withdrawal syndrome'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0087169', 'cui_str': 'Withdrawal symptom'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040604', 'cui_str': 'Trail making test'}, {'cui': 'C0015683', 'cui_str': 'Fatty-acid synthase'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",60.0,0.0656059,"Compared with the placebo group, crocin resulted in a significant improvement in craving score (p = .03), and withdrawal symptoms score (p = .01) in the intervention group.","[{'ForeName': 'Samira', 'Initials': 'S', 'LastName': 'Abbaszadeh-Mashkani', 'Affiliation': 'Trauma Nursing Research Center, Faculty of Nursing and Midwifery, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Shahanara Sunjida', 'Initials': 'SS', 'LastName': 'Hoque', 'Affiliation': 'Student Research Committee, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Hamid Reza', 'Initials': 'HR', 'LastName': 'Banafshe', 'Affiliation': 'Physiology Research Center, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Ghaderi', 'Affiliation': 'Department of Addiction studies, School of Medical, Kashan University of Medical Sciences, Kashan, Iran.'}]",Phytotherapy research : PTR,['10.1002/ptr.6913']
1527,33078518,Long-Term Effects of Self-Administered Transcranial Direct Current Stimulation in Episodic Migraine Prevention: Results of a Randomized Controlled Trial.,"BACKGROUND


Migraine is a multifactorial neurovascular disorder, which affects about 12% of the general population. In episodic migraine, the visual cortex revealed abnormal processing, most likely due to decreased preactivation level. Transcranial direct current stimulation (tDCS) is able to modify cortical excitability and might result in an alleviation of migraine occurrence if used repetitively.
OBJECTIVE


To test the hypothesis that self-administered anodal tDCS over the visual cortex significantly decreases the number of monthly migraine days in episodic migraine.
MATERIALS AND METHODS


The study was single-blind, randomized, and sham-controlled. Inclusion criteria were age 18-80 years and an ICHD-3 diagnosis of episodic migraine. Exclusion criteria were pregnancy, presence of a neurodegenerative disorder, a contraindication against MRI examinations, and less than two migraine days during the 28-day baseline period. Patients in whom the baseline period suggested chronic migraine were excluded. After baseline, participants applied daily either verum (anodal-1 mA to 20 min) or sham tDCS (anodal-1 mA to 30 sec) at Oz (reference Cz electrode) for 28 days. Headache diaries were used to record the number of migraine days at baseline, during the stimulation period, and during four subsequent 28-day periods.
RESULTS


Twenty-eight patients were included; two were excluded after the baseline period because less than two migraine days occurred; three were excluded because their headache diaries suggested the diagnosis of chronic migraine. Twenty-three datasets were taken for further analysis. Compared to sham tDCS (n = 12), verum tDCS (n = 11) resulted in a lower number of migraine days (p = 0.010) across all follow-up periods. We found no significant change in total headache days (p = 0.165), anxiety (p = 0.884), or depression scores (p = 0.535). No serious adverse events occurred; minor side effects were similar in both groups.
CONCLUSIONS


This study provides Class II evidence that self-administered anodal tDCS over the visual cortex in episodic migraine results in a significantly lower number of monthly migraine days. However, it has neither an immediate nor a long-term effect.",2020,"We found no significant change in total headache days (p = 0.165), anxiety (p = 0.884), or depression scores (p = 0.535).","['Inclusion criteria were age 18-80\u2009years and an ICHD-3 diagnosis of episodic migraine', 'Episodic Migraine Prevention']","['Transcranial direct current stimulation (tDCS', 'Self-Administered Transcranial Direct Current Stimulation', 'sham tDCS', 'verum (anodal-1 mA to 20\u2009min) or sham tDCS (anodal-1 mA to 30\u2009sec) at Oz (reference Cz electrode', 'verum tDCS', 'anodal tDCS']","['chronic migraine', 'Headache diaries', 'total headache days', 'depression scores', 'number of migraine days', 'anxiety']","[{'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C4760993', 'cui_str': 'Episodic migraine'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1172076', 'cui_str': '1-(1-phenylethyl)-2-methyleneaziridine'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0059387', 'cui_str': 'staphylococcal enterotoxin C'}, {'cui': 'C0013812', 'cui_str': 'Electrode'}]","[{'cui': 'C1960870', 'cui_str': 'Transformed migraine'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",28.0,0.115028,"We found no significant change in total headache days (p = 0.165), anxiety (p = 0.884), or depression scores (p = 0.535).","[{'ForeName': 'Heiko', 'Initials': 'H', 'LastName': 'Pohl', 'Affiliation': 'Department of Neurology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Marius', 'Initials': 'M', 'LastName': 'Moisa', 'Affiliation': 'Zurich Center for Neuroeconomics (ZNE), Department of Economics, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Hans-H', 'Initials': 'HH', 'LastName': 'Jung', 'Affiliation': 'Department of Neurology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Brenner', 'Affiliation': 'Department of Neuroradiology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Aschmann', 'Affiliation': 'Department of Neuroradiology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Franz', 'Initials': 'F', 'LastName': 'Riederer', 'Affiliation': 'Department of Neurology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Christian C', 'Initials': 'CC', 'LastName': 'Ruff', 'Affiliation': 'Zurich Center for Neuroeconomics (ZNE), Department of Economics, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Schoenen', 'Affiliation': 'Headache Research Unit, Department of Neurology-Citadelle Hospital, University of Liège, Liège, Belgium.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Luechinger', 'Affiliation': 'Institute for Biomedical Engineering, ETH Zurich and University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Widmer', 'Affiliation': 'Department of Neurology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Jens A', 'Initials': 'JA', 'LastName': 'Petersen', 'Affiliation': 'Neurozentrum Bern, Bern, Switzerland.'}, {'ForeName': 'Andreas R', 'Initials': 'AR', 'LastName': 'Gantenbein', 'Affiliation': 'Department of Neurology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Peter S', 'Initials': 'PS', 'LastName': 'Sandor', 'Affiliation': 'Department of Neurology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Michels', 'Affiliation': 'Department of Neuroradiology, University Hospital Zurich, Zurich, Switzerland.'}]",Neuromodulation : journal of the International Neuromodulation Society,['10.1111/ner.13292']
1528,33078599,The post-progression survival of patients with recurrent or persistent ovarian clear cell carcinoma: results from a randomized phase III study in JGOG3017/GCIG.,"OBJECTIVE


In this study we sought to investigate the clinical factors that affect post-progression survival (PPS) in patients with recurrent or persistent clear cell carcinoma (CCC). We utilized the JGOG3017/Gynecological Cancer InterGroup data to compare paclitaxel plus carboplatin (TC) and irinotecan plus cisplatin (CPT-P) in the treatment of stages I to IV CCC.
METHODS


We enrolled 166 patients with recurrent or persistent CCC and assessed the impact of variables, including platinum sensitivity, treatment arm, crossover chemotherapy, primary stage, residual tumor at primary surgery, performance status, ethnicity, and tumor reduction surgery at recurrence on the median of PPS in patients with recurrent or persistent CCC.
RESULTS


A total of 77 patients received TC, and 89 patients received CPT-P. The median PPS for patients with platinum-resistant disease was 10.9 months, compared with 18.8 months for patients with platinum-sensitive disease (hazard ratio [HR]=1.88; 95% confidence interval [CI]=1.30-2.72; log-rank p<0.001). In the multivariate analysis, the platinum sensitivity (resistant vs. sensitivity; HR=1.60; p=0.027) and primary stage (p=0.009) were identified as independent predictors of prognosis factors for PPS in recurrent or persistent CCC.
CONCLUSIONS


Our findings revealed that platinum sensitivity and primary stage are clinical factors that significantly affect PPS in patients with recurrent or persistent CCC as well as other histologic subtypes of ovarian cancer. PPS in patients with recurrent CCC should establish the basis for future clinical trials in this population.",2020,"In the multivariate analysis, the platinum sensitivity (resistant vs. sensitivity; HR=1.60; p=0.027) and primary stage (p=0.009) were identified as independent predictors of prognosis factors for PPS in recurrent or persistent CCC.
","['patients with recurrent CCC', 'patients with recurrent or persistent clear cell carcinoma (CCC', '77 patients received TC, and 89 patients received', 'patients with recurrent or persistent CCC', '166 patients with recurrent or persistent CCC and assessed the impact of variables, including platinum sensitivity, treatment arm, crossover chemotherapy, primary stage, residual tumor at primary surgery, performance status, ethnicity, and tumor reduction surgery at recurrence on the median of PPS in patients with recurrent or persistent CCC', 'patients with recurrent or persistent ovarian clear cell carcinoma']","['paclitaxel plus carboplatin (TC) and irinotecan plus cisplatin (CPT-P', 'CPT-P', 'JGOG3017/GCIG']","['progression survival (PPS', 'median PPS', 'platinum sensitivity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0007097', 'cui_str': 'Carcinoma'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0206681', 'cui_str': 'Clear cell adenocarcinoma'}, {'cui': 'C5191361', 'cui_str': '166'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0543478', 'cui_str': 'Residual Tumour'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C3544205', 'cui_str': 'Ovarian clear cell carcinoma'}]","[{'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0006938', 'cui_str': 'Captopril'}]","[{'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]",166.0,0.0744463,"In the multivariate analysis, the platinum sensitivity (resistant vs. sensitivity; HR=1.60; p=0.027) and primary stage (p=0.009) were identified as independent predictors of prognosis factors for PPS in recurrent or persistent CCC.
","[{'ForeName': 'Eiji', 'Initials': 'E', 'LastName': 'Kondo', 'Affiliation': 'Department of Obstetrics and Gynecology, Mie University School of medicine, Tsu, Japan. eijikon@clin.medic.mie-u.ac.jp.'}, {'ForeName': 'Tsutomu', 'Initials': 'T', 'LastName': 'Tabata', 'Affiliation': ""Department of Obstetrics and Gynecology, Tokyo Women's Medical University, Tokyo, Japan.""}, {'ForeName': 'Nao', 'Initials': 'N', 'LastName': 'Suzuki', 'Affiliation': 'Department of Obstetrics and Gynecology, St. Marianna University School of Medicine, Kawasaki, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Aoki', 'Affiliation': 'Department of Obstetrics and Gynecology, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Yahata', 'Affiliation': 'Department of Obstetrics and Gynecology, Kyushu University School of Medicine, Fukuoka, Japan.'}, {'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Kotera', 'Affiliation': 'Division of Clinical Research, Global Clinical Research Coordinating Center, Kitasato University, Tokyo, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Tokuyama', 'Affiliation': 'Department of Obstetrics and Gynecology, Osaka City General Hospital, Osaka, Japan.'}, {'ForeName': 'Keiichi', 'Initials': 'K', 'LastName': 'Fujiwara', 'Affiliation': 'Department of Obstetrics and Gynecology, Saitama Medical University International Medical Center, Hidaka, Japan.'}, {'ForeName': 'Eizo', 'Initials': 'E', 'LastName': 'Kimura', 'Affiliation': 'Department of Obstetrics and Gynecology, Kosei General Hospital, Kutchan, Japan.'}, {'ForeName': 'Fumitoshi', 'Initials': 'F', 'LastName': 'Terauchi', 'Affiliation': 'Department of Obstetrics and Gynecology, Tokyo Medical University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Toshiyuki', 'Initials': 'T', 'LastName': 'Sumi', 'Affiliation': 'Department of Obstetrics and Gynecology, Osaka City University School of Medicine, Osaka, Japan.'}, {'ForeName': 'Aikou', 'Initials': 'A', 'LastName': 'Okamoto', 'Affiliation': 'Department of Obstetrics and Gynecology, The Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Nobuo', 'Initials': 'N', 'LastName': 'Yaegashi', 'Affiliation': 'Department of Obstetrics and Gynecology, Tohoku University Graduate School of Medicine, Sendai, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Enomoto', 'Affiliation': 'Department of Obstetrics and Gynecology, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan.'}, {'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Sugiyama', 'Affiliation': 'Department of Obstetrics and Gynecology, Iwate Medical University School of Medicine, Morioka, Japan.'}]",Journal of gynecologic oncology,['10.3802/jgo.2020.31.e94']
1529,33078600,Olaparib and bevacizumab in front-line maintenance of ovarian cancer: an over reliance in unpowered subgroup analysis of the PAOLA-1 trial?,,2020,,['ovarian cancer'],['Olaparib and bevacizumab'],[],"[{'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}]","[{'cui': 'C2316164', 'cui_str': 'olaparib'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]",[],,0.211095,,"[{'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Paulino', 'Affiliation': 'Brazilian National Cancer Institute and Grupo Oncoclínicas, Rio de Janeiro, Brazil. dudupaulino@globo.com.'}, {'ForeName': 'Andreia Cristina', 'Initials': 'AC', 'LastName': 'de Melo', 'Affiliation': 'Brazilian National Cancer Institute and Grupo Oncoclínicas, Rio de Janeiro, Brazil.'}]",Journal of gynecologic oncology,['10.3802/jgo.2020.31.e95']
1530,33078615,"Ingestion of Fecal Bacteria along Multiple Pathways by Young Children in Rural Bangladesh Participating in a Cluster-Randomized Trial of Water, Sanitation, and Hygiene Interventions (WASH Benefits).","Quantifying the contribution of individual exposure pathways to a child's total ingestion of fecal matter could help prioritize interventions to reduce environmental enteropathy and diarrhea. This study used data on fecal contamination of drinking water, food, soil, hands, and objects and second-by-second data on children's contacts with these environmental reservoirs in rural Bangladesh to assess the relative contribution of different pathways to children's ingestion of fecal indicator bacteria and if ingestion decreased with the water, sanitation, and hygiene interventions implemented in the WASH Benefits Trial. Our model estimated that rural Bangladeshi children <36 months old consume 3.6-4.9 log 10  most probable number  E. coli /day. Among children <6 months, placing objects in the mouth accounted for 60% of  E. coli  ingested. For children 6-35 months old, mouthing their own hands, direct soil ingestion, and ingestion of contaminated food were the primary pathways of  E. coli  ingestion. The amount of  E. coli  ingested by children and the predominant pathways of  E. coli  ingestion were unchanged by the water, sanitation, and hygiene interventions. These results highlight contaminated soil, children's hands, food, and objects as primary pathways of  E. coli  ingestion and emphasize the value of intervening along these pathways.",2020,"The amount of  E. coli  ingested by children and the predominant pathways of  E. coli  ingestion were unchanged by the water, sanitation, and hygiene interventions.","[""children's contacts with these environmental reservoirs in rural Bangladesh"", 'Young Children in Rural Bangladesh', 'rural Bangladeshi children <36 months old consume 3.6-4.9 log 10  most probable number  E. coli /day']",[],"['fecal contamination of drinking water, food, soil, hands, and objects and second']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0442537', 'cui_str': 'Reservoir'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0422784', 'cui_str': 'Bangladeshi'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C4517694', 'cui_str': '3.6'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0014834', 'cui_str': 'Escherichia coli'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",[],"[{'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0599638', 'cui_str': 'Drinking Water'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0037592', 'cui_str': 'Soil'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0347997', 'cui_str': 'Physical object'}, {'cui': 'C0205436', 'cui_str': 'Second'}]",,0.0323596,"The amount of  E. coli  ingested by children and the predominant pathways of  E. coli  ingestion were unchanged by the water, sanitation, and hygiene interventions.","[{'ForeName': 'Laura H', 'Initials': 'LH', 'LastName': 'Kwong', 'Affiliation': 'Woods Institute for the Environment, Stanford University, Stanford, California 94305, United States.'}, {'ForeName': 'Ayse', 'Initials': 'A', 'LastName': 'Ercumen', 'Affiliation': 'Department of Forestry and Environmental Resources, North Carolina State University, Raleigh, North Carolina 27695, United States.'}, {'ForeName': 'Amy J', 'Initials': 'AJ', 'LastName': 'Pickering', 'Affiliation': 'Department of Civil and Environmental Engineering, Tufts University, Medford, Massachusetts 02155, United States.'}, {'ForeName': 'Joanne E', 'Initials': 'JE', 'LastName': 'Arsenault', 'Affiliation': 'Program in International Community Nutrition, University of California, Davis, California 95616, United States.'}, {'ForeName': 'Mahfuza', 'Initials': 'M', 'LastName': 'Islam', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka 1000, Bangladesh.'}, {'ForeName': 'Sarker M', 'Initials': 'SM', 'LastName': 'Parvez', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka 1000, Bangladesh.'}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Unicomb', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka 1000, Bangladesh.'}, {'ForeName': 'Mahbubur', 'Initials': 'M', 'LastName': 'Rahman', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka 1000, Bangladesh.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Davis', 'Affiliation': 'Woods Institute for the Environment, Stanford University, Stanford, California 94305, United States.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Luby', 'Affiliation': 'Woods Institute for the Environment, Stanford University, Stanford, California 94305, United States.'}]",Environmental science & technology,['10.1021/acs.est.0c02606']
1531,33078627,The Effect of 5-Minute Mindfulness of Peace on Suffering and Spiritual Well-Being Among Palliative Care Patients: A Randomized Controlled Study.,"BACKGROUND


Mindfulness practices may have a role in reducing suffering and improving spiritual well-being among patients with serious illness. The efficacy, feasibility and acceptability of such interventions warrant further exploration in the palliative care population.
OBJECTIVE


To investigate the effect of a brief mindfulness practice, the 5-minute mindfulness of peace intervention, on suffering and spiritual well-being among palliative care patients.
METHODS


A randomized controlled study was conducted on adult palliative care patients with moderate to severe levels of suffering. Participants in the intervention arm were guided through a 5-minute mindfulness of peace exercise while participants in the control arm received 5 minutes of active listening. Pre- and post-intervention suffering and spiritual well-being were measured using the Suffering Pictogram and the FACIT-Sp-12 questionnaire, respectively.
RESULTS


40 participants completed the study. 5-minute mindfulness of peace significantly reduced suffering (median = -3.00, IQR = 2.00) more than 5 minutes of active listening (median = -1.00, IQR = 1.75), U = 73.50, z = -3.48, p = 0.001, η 2  = 0.31. FACIT-Sp-12 score also significantly improved in the intervention arm (median = +5.00, IQR = 2.75) compared with the control arm after 5 minutes (median = +1.00, IQR = 3.00), U = 95.50, z = -2.85, p = 0.004, η 2  = 0.21.
CONCLUSIONS


A brief 5-minute mindfulness of peace exercise is effective in providing immediate relief of suffering and improving spiritual well-being. It is a useful and feasible intervention among patients receiving palliative care for rapidly and momentarily reducing spiritual suffering.",2020,"mindfulness of peace significantly reduced suffering (median = -3.00,","['40 participants completed the study', 'patients with serious illness', 'patients receiving palliative care for rapidly and momentarily reducing spiritual suffering', 'adult palliative care patients with moderate to severe levels of suffering', 'suffering and spiritual well-being among palliative care patients', 'on Suffering and Spiritual Well-Being Among Palliative Care Patients']","['5-Minute Mindfulness of Peace', 'peace exercise', '5-minute mindfulness of peace exercise while participants in the control arm received 5 minutes of active listening']","['FACIT-Sp-12 score', 'efficacy, feasibility and acceptability']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0518881', 'cui_str': 'Level of suffering'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0150122', 'cui_str': 'Active listening'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",40.0,0.0477533,"mindfulness of peace significantly reduced suffering (median = -3.00,","[{'ForeName': 'Lim Liang', 'Initials': 'LL', 'LastName': 'Yik', 'Affiliation': 'Palliative Care Unit, Faculty of Medicine, Department of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Look Mei', 'Initials': 'LM', 'LastName': 'Ling', 'Affiliation': 'Palliative Care Unit, Faculty of Medicine, Department of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Lim Min', 'Initials': 'LM', 'LastName': 'Ai', 'Affiliation': 'Palliative Care Unit, Faculty of Medicine, Department of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Ang Bin', 'Initials': 'AB', 'LastName': 'Ting', 'Affiliation': 'Palliative Care Unit, Faculty of Medicine, Department of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'David Paul', 'Initials': 'DP', 'LastName': 'Capelle', 'Affiliation': 'Palliative Care Unit, Faculty of Medicine, Department of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Sheriza Izwa', 'Initials': 'SI', 'LastName': 'Zainuddin', 'Affiliation': 'Palliative Care Unit, Faculty of Medicine, Department of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Tan Seng', 'Initials': 'TS', 'LastName': 'Beng', 'Affiliation': 'Palliative Care Unit, Faculty of Medicine, Department of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Loh Ee', 'Initials': 'LE', 'LastName': 'Chin', 'Affiliation': 'Palliative Care Unit, Faculty of Medicine, Department of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Lam Chee', 'Initials': 'LC', 'LastName': 'Loong', 'Affiliation': 'Palliative Care Unit, Faculty of Medicine, Department of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}]",The American journal of hospice & palliative care,['10.1177/1049909120965944']
1532,33078636,"Effects of Concurrent Training and a Multi-Ingredient Performance Supplement Containing  Rhodiola rosea  and  Cordyceps sinensis  on Body Composition, Performance, and Health in Active Men.","INTRODUCTION


Supplementation with  Rhodiola Rosea (RR)  and  Cordyceps Sinensis (CS)  has been shown to improve aerobic performance, but their influence on concurrent training (resistance training plus high intensity interval training) outcomes has not been established. The purpose of this study was to determine the effects of supplementation with a multi-ingredient performance supplement (MIPS) containing RR and CS during a 14-week training and testing program on body composition, weekly exercise training outcomes, overall training and performance outcomes, and hormone profiles.
METHODS


Active college-aged men ( N     =   21) were stratified into either a MIPS or a placebo (PLA) group. Both groups completed 14   weeks of training and testing. Body composition, overall training outcomes, and blood sample collection occurred at weeks 0, 7, and 14, while training performance was evaluated weekly.
RESULTS


Both groups improved ( p     <   0.05) percent body fat (-1.3%), bench press (+4%) and squat strength (+8%), with no difference between groups. Serum cortisol concentrations significantly decreased (-11%) but there were no differences between groups. No other changes in blood hormone profiles occurred. Weekly exercise performance data suggests that MIPS improved sprint performance, bench press lifting volume, and total workload, but this did not lead to improved overall training performance compared to PLA over the14-week study.
CONCLUSION


Despite MIPS improving certain aspects of weekly training performance, supplementation with MIPS for 14   weeks did not improve body composition, overall training and performance outcomes, or blood biomarkers of health in response to concurrent training in young men compared to PLA. This study was registered with clinicaltrials. gov (NCT02383017).",2020,"Both groups improved ( p     <   0.05) percent body fat (-1.3%), bench press (+4%) and squat strength (+8%), with no difference between groups.","['Active college-aged men ( N   \u2009 = \u2009 21', 'Active Men']","['Cordyceps Sinensis (CS', 'Concurrent Training', 'Supplementation with  Rhodiola Rosea (RR)  and', 'supplementation with a multi-ingredient performance supplement (MIPS) containing RR and CS', 'MIPS or a placebo (PLA']","['squat strength', 'sprint performance, bench press lifting volume, and total workload', 'blood hormone profiles', 'overall training performance', 'body fat', 'body composition, overall training and performance outcomes, or blood biomarkers of health in response to concurrent training', 'Body composition, overall training outcomes, and blood sample collection', 'body composition, weekly exercise training outcomes, overall training and performance outcomes, and hormone profiles', 'Serum cortisol concentrations', 'Body Composition, Performance, and Health']","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C1011843', 'cui_str': 'Cordyceps'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0950014', 'cui_str': 'Roseroot'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0376579', 'cui_str': 'Macrophage Inflammatory Proteins'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0456170', 'cui_str': 'Left atrial pressure'}]","[{'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0454326', 'cui_str': 'Bench press'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0236396', 'cui_str': 'Serum cortisol measurement'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",21.0,0.0704595,"Both groups improved ( p     <   0.05) percent body fat (-1.3%), bench press (+4%) and squat strength (+8%), with no difference between groups.","[{'ForeName': 'Vince C', 'Initials': 'VC', 'LastName': 'Kreipke PhD', 'Affiliation': 'Department of Nutrition, Food and Exercise Sciences, Institute of Sports Sciences and Medicine, Florida State University, Tallahassee, FL, USA.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Moffatt PhD', 'Affiliation': 'Department of Nutrition, Food and Exercise Sciences, Institute of Sports Sciences and Medicine, Florida State University, Tallahassee, FL, USA.'}, {'ForeName': 'Charles J', 'Initials': 'CJ', 'LastName': 'Tanner Ma', 'Affiliation': 'Department of Kinesiology, Human Performance Laboratory, East Carolina University, Greenville, NC, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Ormsbee PhD', 'Affiliation': 'Department of Nutrition, Food and Exercise Sciences, Institute of Sports Sciences and Medicine, Florida State University, Tallahassee, FL, USA.'}]",Journal of dietary supplements,['10.1080/19390211.2020.1822486']
1533,33078646,"The Effect of Multi-Vitamin/Multi-Mineral Supplementation on Nutritional Status in Older Adults Receiving Drug Therapies: A Double-Blind, Placebo-Controlled Trial.","Polypharmacy regimens may increase the susceptibility of older adults to micronutrient inadequacy and deficiency  via  impairment of nutritional status. We hypothesized that a multi-vitamin-mineral supplement (MVMS) could improve nutritional status in older adults prescribed diuretics, metformin, and/or proton pump inhibitors (PPIs). We conducted a randomized, double-blind, placebo controlled, parallel clinical trial in which eligible subjects were instructed to consume either a MVMS or placebo for 16 wk. Fasting blood was collected at baseline, 8, and 16 wk and the status of selected vitamins and minerals determined. Thirty-five and 19 men and women aged 45-75 yrs in the in MVMS and placebo arms, respectively, completed the trial. The mean total number of medications among the three drug classes taken by participants did not differ between two groups. The status of vitamins B1, B12, C and folate and calcium, copper, magnesium and zinc at baseline were within normal ranges. The MVMS group had a greater change in nutrient status after 16 wk compared to the placebo group for serum folate (7.5 vs. -1.6 ng/mL,  p  < 0.0001), vitamin B12 (159.2 vs. -33.9 pg/mL,  p  = 0.007), and plasma vitamin C (0.2 vs. 0.0 mg/dL,  p  = 0.004). Other measured vitamins and minerals were not significantly changed during the intervention. In conclusion, the status of vitamins B12, C and folate improved with MVMS but remained within normal ranges in older adults taking diuretics, metformin, and/or PPIs.",2020,"The MVMS group had a greater change in nutrient status after 16 wk compared to the placebo group for serum folate (7.5 vs. -1.6 ng/mL,  p  < 0.0001), vitamin B12 (159.2 vs. -33.9 pg/mL,  p  = 0.007), and plasma vitamin C (0.2 vs. 0.0 mg/dL,  p  = 0.004).","['Thirty-five and 19 men and women aged 45-75\u2009yrs in the in MVMS and placebo arms, respectively, completed the trial', 'Older Adults', 'older adults prescribed']","['Multi-Vitamin/Multi-Mineral Supplementation', 'multi-vitamin-mineral supplement (MVMS', 'MVMS', 'diuretics, metformin, and/or proton pump inhibitors (PPIs', 'Polypharmacy regimens', 'Receiving Drug Therapies', 'placebo', 'Placebo', 'MVMS or placebo']","['mean total number of medications', 'nutrient status', 'vitamin B12', 'serum folate', 'status of vitamins B1, B12, C and folate and calcium, copper, magnesium and zinc', 'Fasting blood', 'status of vitamins B12, C and folate improved with MVMS', 'plasma vitamin C']","[{'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}]","[{'cui': 'C0301532', 'cui_str': 'Multivitamin preparation'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0556112', 'cui_str': 'Mineral supplement'}, {'cui': 'C0012798', 'cui_str': 'Diuretic'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C2922974', 'cui_str': 'Polypharmacy'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0042845', 'cui_str': 'Vitamin B 12'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C0039840', 'cui_str': 'Thiamine'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0009968', 'cui_str': 'Copper'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}]",,0.589401,"The MVMS group had a greater change in nutrient status after 16 wk compared to the placebo group for serum folate (7.5 vs. -1.6 ng/mL,  p  < 0.0001), vitamin B12 (159.2 vs. -33.9 pg/mL,  p  = 0.007), and plasma vitamin C (0.2 vs. 0.0 mg/dL,  p  = 0.004).","[{'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Chen', 'Affiliation': 'Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University, Boston, MA, USA.'}, {'ForeName': 'Gail T', 'Initials': 'GT', 'LastName': 'Rogers', 'Affiliation': 'Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University, Boston, MA, USA.'}, {'ForeName': 'Diane L', 'Initials': 'DL', 'LastName': 'McKay', 'Affiliation': 'Friedman School of Nutrition Science and Policy, Tufts University, Boston, MA, USA.'}, {'ForeName': 'Kevin C', 'Initials': 'KC', 'LastName': 'Maki', 'Affiliation': 'Midwest Biomedical Research, Addison, IL, USA.'}, {'ForeName': 'Jeffrey B', 'Initials': 'JB', 'LastName': 'Blumberg', 'Affiliation': 'Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University, Boston, MA, USA.'}]",Journal of dietary supplements,['10.1080/19390211.2020.1834050']
1534,33078655,Home Visiting Effects on Breastfeeding and Bedsharing in a Low-Income Sample.,"BACKGROUND


Research suggests that home visiting interventions can promote breastfeeding initiation, though their effects on breastfeeding continuation are unclear. No known studies have assessed the impact of home visiting on bedsharing.
AIMS


To test the effects of home visiting on breastfeeding and bedsharing in a low-income, urban sample in the United States.
METHODS


During a field trial conducted in Milwaukee, Wisconsin, from April 2014 to March 2017, referrals to a public health department were randomized to a Healthy Families America (HFA) program or a prenatal care and coordination (PNCC) program. Of the 204 women who accepted services, 139 consented to the study and were allocated to the two treatment groups, which were compared with each other and a third quasi-experimental group of 100 women who did not accept services. Data were collected at four time points up to 12 months postpartum.
RESULTS


Breastfeeding initiation was higher among 72 HFA participants (88.4%; odds ratio [OR] = 2.7) and 67 PNCC participants (88.5%; OR = 2.2) than 100 comparison participants (76.5%). Similar results emerged for breastfeeding duration, though group differences were not statistically significant. Unexpectedly, bedsharing prevalence was higher among HFA participants (56.5%) than PNCC participants (31.1%; OR = 2.9) and comparison group participants (38.8%; OR = 2.0).
DISCUSSION


Home visiting was linked to increased breastfeeding, while effects on bedsharing varied by program. Progress toward  precision home visiting  will be advanced by identifying program components that promote breastfeeding and safe sleep.
CONCLUSION


Further research is needed to examine whether home visiting reduces disparities in breastfeeding and safe sleep practices.",2020,"RESULTS


Breastfeeding initiation was higher among 72 HFA participants (88.4%; odds ratio [OR] = 2.7) and 67 PNCC participants (88.5%; OR = 2.2) than 100 comparison participants (76.5%).","['204 women who accepted services, 139 consented to the study', '100 women who did not accept services', 'Milwaukee, Wisconsin, from April 2014 to March 2017, referrals to a public health department']","['Healthy Families America (HFA) program or a prenatal care and coordination (PNCC) program', 'home visiting']","['bedsharing prevalence', 'Breastfeeding initiation', 'breastfeeding duration']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1272684', 'cui_str': 'Accepted'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0043193', 'cui_str': 'Wisconsin'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0002454', 'cui_str': 'America'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0242414', 'cui_str': 'Coordination'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]","[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]",72.0,0.0349749,"RESULTS


Breastfeeding initiation was higher among 72 HFA participants (88.4%; odds ratio [OR] = 2.7) and 67 PNCC participants (88.5%; OR = 2.2) than 100 comparison participants (76.5%).","[{'ForeName': 'Joshua P', 'Initials': 'JP', 'LastName': 'Mersky', 'Affiliation': 'University of Wisconsin-Milwaukee, Milwaukee, WI, USA.'}, {'ForeName': 'Colleen E', 'Initials': 'CE', 'LastName': 'Janczewski', 'Affiliation': 'University of Wisconsin-Milwaukee, Milwaukee, WI, USA.'}, {'ForeName': 'ChienTi', 'Initials': 'C', 'LastName': 'Plummer Lee', 'Affiliation': 'University of Wisconsin-Milwaukee, Milwaukee, WI, USA.'}, {'ForeName': 'Ross M', 'Initials': 'RM', 'LastName': 'Gilbert', 'Affiliation': 'University of Wisconsin-Madison, Madison, WI, USA.'}, {'ForeName': 'Cali', 'Initials': 'C', 'LastName': 'McAtee', 'Affiliation': 'University of Wisconsin-Milwaukee, Milwaukee, WI, USA.'}, {'ForeName': 'Tajammal', 'Initials': 'T', 'LastName': 'Yasin', 'Affiliation': 'University of Wisconsin-Milwaukee, Milwaukee, WI, USA.'}]",Health education & behavior : the official publication of the Society for Public Health Education,['10.1177/1090198120964197']
1535,33078649,The Effect of Mindfulness-Based Stress Reduction Group Counseling on Psychological and Inflammatory Responses of the Women With Breast Cancer.,"Introduction:  Breast cancer is common among women and reduces their quality of life. The current study aimed to investigate the effectiveness of mindfulness-based stress reduction group counseling in alleviating psychological responses such as anxiety, depression, stress, and regulating laboratory tests including cortisol and C-reactive protein (CRP) in women with breast cancer.  Methods:  This randomized clinical trial was conducted based on convenience sampling. Participants were divided into 2 groups (control and intervention groups) with block randomization. The intervention group received mindfulness-based stress reduction group counseling during 8 weeks. The participants completed the Beck anxiety inventory, Beck-II depression inventory, and perceived stress scale before and after the intervention and their blood samples were taken to check their cortisol and CRP.  Results:  After the intervention, the MBSR group had significantly lower anxiety compared with the control group ( P  < .001). No significant difference was found between the 2 groups in the reduction of perceived stress and depression ( P  < .05). In addition, no significant difference was found between the 2 groups in CRP and cortisol levels after the intervention ( P  > .05).  Conclusion:  The present study showed the effectiveness of mindfulness-based cognitive therapy in improving anxiety rather than the stress, depression, and inflammatory laboratory factors such as cortisol and CRP in women with breast cancer. Therefore, the psychological symptoms of these patients can be improved at different stages of treatment by providing this type of training.",2020,No significant difference was found between the 2 groups in the reduction of perceived stress and depression ( P  < .05).,"['women with breast cancer', 'Women With Breast Cancer']","['mindfulness-based cognitive therapy', 'mindfulness-based stress reduction group counseling', 'Mindfulness-Based Stress Reduction Group Counseling']","['anxiety, depression, stress, and regulating laboratory tests including cortisol and C-reactive protein (CRP', 'CRP and cortisol levels', 'reduction of perceived stress and depression', 'Beck anxiety inventory, Beck-II depression inventory, and perceived stress scale', 'anxiety']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0237547', 'cui_str': 'Group counseling'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0582613', 'cui_str': 'Beck anxiety inventory'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0582653', 'cui_str': 'Perceived stress scale'}]",,0.0180893,No significant difference was found between the 2 groups in the reduction of perceived stress and depression ( P  < .05).,"[{'ForeName': 'Motahareh', 'Initials': 'M', 'LastName': 'Mirmahmoodi', 'Affiliation': 'Nursing Research Center, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Parvin', 'Initials': 'P', 'LastName': 'Mangalian', 'Affiliation': 'Nursing Research Center, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Atefeh', 'Initials': 'A', 'LastName': 'Ahmadi', 'Affiliation': 'Nursing Research Center, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Mahlagha', 'Initials': 'M', 'LastName': 'Dehghan', 'Affiliation': 'Nursing Research Center, Kerman University of Medical Sciences, Kerman, Iran.'}]",Integrative cancer therapies,['10.1177/1534735420946819']
1536,33078664,Effect of Albumin Addition to Cardiopulmonary Bypass Prime on Outcomes in Children Undergoing Open-Heart Surgery (EACPO Study)-A Randomized Controlled Trial.,"BACKGROUND


There is a paucity of literature regarding the association of high oncotic priming solutions for pediatric cardiopulmonary bypass (CPB) and outcomes, and no consensus exists regarding the composition of optimal CPB priming solution. This study aimed to examine the impact of high oncotic pressure priming by the addition of 20% human albumin on outcomes.
METHODS


Double-blinded, randomized controlled study was done in the pediatric cardiac intensive care unit of a tertiary care hospital. Consecutive children with congenital heart diseases admitted for open-heart surgery were randomized into two groups, where the study group received an additional 20% albumin to conventional blood prime before CPB initiation.
RESULTS


We enrolled 39 children in the high oncotic prime (added albumin) group and 37 children in the conventional prime group. In the first 24-hour postoperative period, children in the albumin group had significantly lower occurrence of hypotension (28.2% vs 54%,  P  = .02), requirement of fluid boluses (25.6% vs 54%,  P  = .006), and lactate clearance time (6 vs 9 hours,  P  < .001). Albumin group also had significantly higher platelet count (×10 3 /µL) at 24 hours (112 vs 91,  P  = .02). There was no significant difference in intra-CPB hemodynamic parameters and incidence of acute kidney injury. In subgroup analysis based on risk category, significantly decreased intensive care unit stay (4 vs 5 days,  P  = .04) and hospital stay (5 vs 7 days,  P  = .002) were found in the albumin group in low-risk category.
CONCLUSION


High oncotic pressure CPB prime using albumin addition might be beneficial over conventional blood prime, and our study does provide a rationale for further studies.",2020,"In subgroup analysis based on risk category, significantly decreased intensive care unit stay (4 vs 5 days,  P  = .04) and hospital stay (5 vs 7 days,  P  = .002) were found in the albumin group in low-risk category.
","['pediatric cardiac intensive care unit of a tertiary care hospital', '39 children in the high oncotic prime (added albumin) group and 37 children in the conventional prime group', 'Consecutive children with congenital heart diseases admitted for open-heart surgery', 'Children Undergoing Open-Heart Surgery (EACPO Study)-A Randomized Controlled Trial', 'pediatric cardiopulmonary bypass (CPB']","['Albumin', 'Albumin Addition to Cardiopulmonary Bypass Prime', 'additional 20% albumin to conventional blood prime before CPB initiation']","['requirement of fluid boluses', 'hospital stay', 'occurrence of hypotension', 'intra-CPB hemodynamic parameters and incidence of acute kidney injury', 'lactate clearance time', 'intensive care unit stay', 'platelet count']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0587446', 'cui_str': 'Cardiac intensive care unit'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0071973', 'cui_str': 'PRIME protocol'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0152021', 'cui_str': 'Congenital heart disease'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0189745', 'cui_str': 'Open heart surgery'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}]","[{'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0071973', 'cui_str': 'PRIME protocol'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}]","[{'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}]",39.0,0.28044,"In subgroup analysis based on risk category, significantly decreased intensive care unit stay (4 vs 5 days,  P  = .04) and hospital stay (5 vs 7 days,  P  = .002) were found in the albumin group in low-risk category.
","[{'ForeName': 'Abdul', 'Initials': 'A', 'LastName': 'Rauf', 'Affiliation': 'Department of Pediatric Intensive Care, 28928Sir Ganga Ram Hospital, New Delhi, Delhi, India.'}, {'ForeName': 'Reena K', 'Initials': 'RK', 'LastName': 'Joshi', 'Affiliation': 'Department of Pediatric Cardiac Sciences, 28928Sir Ganga Ram Hospital, New Delhi, Delhi, India.'}, {'ForeName': 'Neeraj', 'Initials': 'N', 'LastName': 'Aggarwal', 'Affiliation': 'Department of Pediatric Cardiac Sciences, 28928Sir Ganga Ram Hospital, New Delhi, Delhi, India.'}, {'ForeName': 'Mridul', 'Initials': 'M', 'LastName': 'Agarwal', 'Affiliation': 'Department of Pediatric Cardiac Sciences, 28928Sir Ganga Ram Hospital, New Delhi, Delhi, India.'}, {'ForeName': 'Manendra', 'Initials': 'M', 'LastName': 'Kumar', 'Affiliation': 'Department of Pediatric Cardiac Sciences, 28928Sir Ganga Ram Hospital, New Delhi, Delhi, India.'}, {'ForeName': 'Veronique', 'Initials': 'V', 'LastName': 'Dinand', 'Affiliation': 'Department of Research, 28928Sir Ganga Ram Hospital, New Delhi, Delhi, India.'}, {'ForeName': 'Raja', 'Initials': 'R', 'LastName': 'Joshi', 'Affiliation': 'Department of Pediatric Intensive Care, 28928Sir Ganga Ram Hospital, New Delhi, Delhi, India.'}]",World journal for pediatric & congenital heart surgery,['10.1177/2150135120959088']
1537,33078673,Validation of Colorectal Cancer Models on Long-Term Outcomes from a Randomized Controlled Trial.,"Microsimulation models are often used to predict long-term outcomes and guide policy decisions regarding cancer screening. The United Kingdom Flexible Sigmoidoscopy Screening (UKFSS) Trial examines a one-time intervention of flexible sigmoidoscopy that was implemented before a colorectal cancer (CRC) screening program was established. Long-term study outcomes, now a full 17 y following randomization, have been published. We use the outcomes from this trial to validate 3 microsimulation models for CRC to long-term study outcomes. We find that 2 of 3 models accurately predict the relative effect of screening (the hazard ratios) on CRC-specific incidence 17 y after screening. We find that all 3 models yield predictions of the relative effect of screening on CRC incidence and mortality (i.e., the hazard ratios) that are reasonably close to the UKFSS results. Two of the 3 models accurately predict the relative reduction in CRC incidence 17 y after screening. One model accurately predicted the absolute incidence and mortality rates in the screened group. The models differ in their estimates related to adenoma detection at screening. Although high-quality screening results help to inform models, trials are expensive, last many years, and can be complicated by ethical issues and technological changes across the duration of the trial. Thus, well-calibrated and validated models are necessary to predict outcomes for which data are not available. The results from this validation demonstrate the utility of models in predicting long-term outcomes and in collaborative modeling to account for uncertainty.",2020,We find that 2 of 3 models accurately predict the relative effect of screening (the hazard ratios) on CRC-specific incidence 17 y after screening.,[],"['flexible sigmoidoscopy', 'United Kingdom Flexible Sigmoidoscopy Screening (UKFSS']","['absolute incidence and mortality rates', 'CRC incidence and mortality']",[],"[{'cui': 'C0016234', 'cui_str': 'Flexible fiberoptic sigmoidoscopy'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}]",,0.0305501,We find that 2 of 3 models accurately predict the relative effect of screening (the hazard ratios) on CRC-specific incidence 17 y after screening.,"[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'DeYoreo', 'Affiliation': 'RAND Corporation, Santa Monica, CA, USA.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Lansdorp-Vogelaar', 'Affiliation': 'Department of Public Health, Erasmus MC, Rotterdam, Zuid-Holland, the Netherlands.'}, {'ForeName': 'Amy B', 'Initials': 'AB', 'LastName': 'Knudsen', 'Affiliation': 'Institute for Technology Assessment and Harvard Medical School, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Karen M', 'Initials': 'KM', 'LastName': 'Kuntz', 'Affiliation': 'Department of Health Policy and Management, University of Minnesota, School of Public Health, Minneapolis, MN, USA.'}, {'ForeName': 'Ann G', 'Initials': 'AG', 'LastName': 'Zauber', 'Affiliation': 'Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, NY, USA.'}, {'ForeName': 'Carolyn M', 'Initials': 'CM', 'LastName': 'Rutter', 'Affiliation': 'RAND Corporation, Santa Monica, CA, USA.'}]",Medical decision making : an international journal of the Society for Medical Decision Making,['10.1177/0272989X20961095']
1538,33078725,Comparison of medication acceptance of intranasal midazolam administered by parents versus doctors in children - A randomized trial.,"BACKGROUND


The positive effects of midazolam as a premedication in pediatric patients are well documented. Although there are many studies regarding the route and dosage of administration, literature does not have any evidence on the outcome of medication acceptance based on the person administering the drug.
AIM


The aim of this study was to compare the medication acceptance and preoperative anxiolysis of intranasal midazolam administered by parents and anesthesiologists.
MATERIALS AND METHODS


This prospective randomized study was conducted in sixty children belonging to the American Society of Anesthesiologists Class 1 or 2 belonging to either sex, aged between 1 and 9 years, undergoing elective surgeries. Group P received intranasal midazolam administered by parents, whereas Group D received intranasal midazolam administered by doctors. Various scores were assessed.
RESULTS


Children were more sedated in Group P. Clinically, medication acceptance was better in Group P when compared with Group D, but a statistically significant difference in medication acceptance was seen only in patients who are >4 years of age. Parental separation, Ramsay Sedation Score, and mask acceptance were better in Group P than in Group D.
CONCLUSION


Intranasal midazolam when given by parents produces better preoperative anxiolysis and easier parental separation as compared with administration by a medical staff.",2020,"RESULTS


Children were more sedated in Group P. Clinically, medication acceptance was better in Group P when compared with Group D, but a statistically significant difference in medication acceptance was seen only in patients who are >4 years of age.","['parents versus doctors in children ', 'sixty children belonging to the American Society of Anesthesiologists Class 1 or 2 belonging to either sex, aged between 1 and 9 years, undergoing elective surgeries', 'pediatric patients']","['Intranasal midazolam', 'midazolam', 'intranasal midazolam']","['medication acceptance and preoperative anxiolysis', 'medication acceptance', 'Parental separation, Ramsay Sedation Score, and mask acceptance', 'preoperative anxiolysis and easier parental separation']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0441885', 'cui_str': 'Class 1'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C1961138', 'cui_str': 'Induction of minimal sedation'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0036679', 'cui_str': 'Separation'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0332219', 'cui_str': 'Easy'}]",60.0,0.0595037,"RESULTS


Children were more sedated in Group P. Clinically, medication acceptance was better in Group P when compared with Group D, but a statistically significant difference in medication acceptance was seen only in patients who are >4 years of age.","[{'ForeName': 'M V S', 'Initials': 'MVS', 'LastName': 'Satya Prakash', 'Affiliation': 'Department of Anaesthesiology and CC, JIPMER, Puducherry, India.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Sivasankar', 'Affiliation': 'Department of Anaesthesiology and CC, JIPMER, Puducherry, India.'}, {'ForeName': 'Lenin Babu', 'Initials': 'LB', 'LastName': 'Elakkumanan', 'Affiliation': 'Department of Anaesthesiology and CC, JIPMER, Puducherry, India.'}, {'ForeName': 'V K', 'Initials': 'VK', 'LastName': 'Mohan', 'Affiliation': 'Department of Anaesthesiology and CC, JIPMER, Puducherry, India.'}, {'ForeName': 'Rithu Krishna', 'Initials': 'RK', 'LastName': 'Kamaladevi', 'Affiliation': 'Department of Anaesthesiology and CC, JIPMER, Puducherry, India.'}]",Indian journal of pharmacology,['10.4103/ijp.IJP_418_19']
1539,33078727,A comparative study of the effect of 10-day esomeprazole containing levofloxacin versus clarithromycin sequential regimens on the treatment of Iranian patients with  Helicobacter pylori  infection.,"OBJECTIVE


Helicobacter Pylori (H. pylori) treatment may be different depending on the host and microbial factors in each region. The study was planned to estimate the effect of two 10-day esomeprazole containing clarithromycin and levofloxacin sequential therapies on H. pylori treatment.
MATERIALS AND METHODS


Totally, 186 H. pylori-infected patients with gastro-duodenal ulcer who had not yet received treatment for infection, were enrolled. We randomly designated patients to group A (N = 94) who treated with esomeprazole 40 mg and amoxicillin 1 g bid during the early half of treatment, and continued the same dose of esomeprazole with levofloxacin 500 mg and tinidazole 500 mg bid during the second half of treatment and Group B (N = 92) who treated with the identical treatment excepting clarithromycin 500 mg bid as a substitute of levofloxacin. To assess eradication, C14-urea breath test was implemented 8 weeks afterward treatment.
RESULTS


Finally, 172 patients completed the trial. We calculated 85.1% (95% confidence interval [CI] = 77.9-92.3) and 83.7% (95% CI = 76.2-91.2) eradication intention-to-treat analysis (P = 0.302) and so, 93.0% (95% CI = 87.6-98.4) and 90.0% (95% CI = 83.6-96.3) eradication by per-protocol analysis (P = 0.420) for Group A and B, respectively. No significant difference was seen among regimens. Drug adverse reactions were not significantly different between regimens. Group A had a 97.8% adherence rate to treatment and Group B had 98.9%.
CONCLUSIONS


Both esomeprazole containing sequential regimens including levofloxacin and clarithromycin showed good eradication rates in spite of significant differences in antimicrobial resistance patterns in vitro. The efficacy of esomeprazole in lowering gastric acidity beside its antimicrobial effect should be considered in H. pylori regimens.",2020,Both esomeprazole containing sequential regimens including levofloxacin and clarithromycin showed good eradication rates in spite of significant differences in antimicrobial resistance patterns in vitro.,"['Iranian patients with  Helicobacter pylori  infection', 'Totally, 186 H. pylori-infected patients with gastro-duodenal ulcer who had not yet received treatment for infection, were enrolled', '172 patients completed the trial']","['levofloxacin and clarithromycin', 'esomeprazole containing clarithromycin and levofloxacin sequential therapies', 'esomeprazole', 'esomeprazole with levofloxacin 500 mg and tinidazole', 'clarithromycin sequential regimens', 'clarithromycin 500 mg bid as a substitute of levofloxacin', 'esomeprazole containing levofloxacin', 'esomeprazole 40 mg and amoxicillin']","['eradication intention-to-treat analysis', 'Drug adverse reactions', 'good eradication rates', 'adherence rate', 'eradication, C14-urea breath test', 'antimicrobial resistance patterns']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0850666', 'cui_str': 'Infection caused by Helicobacter pylori'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C0450199', 'cui_str': 'Gastroduodenal'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C4517601', 'cui_str': '172'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0282386', 'cui_str': 'Levofloxacin'}, {'cui': 'C0055856', 'cui_str': 'Clarithromycin'}, {'cui': 'C0937846', 'cui_str': 'Esomeprazole'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0992502', 'cui_str': 'Levofloxacin 500 MG'}, {'cui': 'C0040263', 'cui_str': 'Tinidazole'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0984982', 'cui_str': 'Clarithromycin 500 MG'}, {'cui': 'C0048106', 'cui_str': ""4-benzamido-4'-isothiocyanostilbene-2,2'-disulfonate""}, {'cui': 'C1127610', 'cui_str': 'Esomeprazole 40 MG'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}]","[{'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0430720', 'cui_str': 'C14 urea breath test'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}]",,0.0806581,Both esomeprazole containing sequential regimens including levofloxacin and clarithromycin showed good eradication rates in spite of significant differences in antimicrobial resistance patterns in vitro.,"[{'ForeName': 'Marjan', 'Initials': 'M', 'LastName': 'Mokhtare', 'Affiliation': 'Colorectal Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Nikkhah', 'Affiliation': 'Gastrointestinal and Liver Disease Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Behdad', 'Initials': 'B', 'LastName': 'Behnam', 'Affiliation': 'Gastrointestinal and Liver Disease Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shahram', 'Initials': 'S', 'LastName': 'Agah', 'Affiliation': 'Colorectal Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mansour', 'Initials': 'M', 'LastName': 'Bahardoust', 'Affiliation': 'Colorectal Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Masoodi', 'Affiliation': 'Colorectal Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Amirhosein', 'Initials': 'A', 'LastName': 'Faghihi', 'Affiliation': 'Colorectal Research Center, Iran University of Medical Sciences, Tehran, Iran.'}]",Indian journal of pharmacology,['10.4103/ijp.IJP_719_19']
1540,33078734,Change in jaw occlusive power by paralysis of masseter muscle with a neuromuscular blocker: Sion's masseter muscle paralysis.,"STUDY OBJECTIVE


We aimed to determine whether jaw occlusive power decreases with the injection of neuromuscular blocking agents in masseter muscle - a method we named Sion's masseter muscle paralysis (SMP).
METHODS


A randomized, placebo-controlled animal study was conducted in which researchers were blinded to group allocation. We used 12 male mongrel dogs aged 10-12 months and weighing 30-35 kg. Four groups were formed: a conventional dose (CD) group (0.004 mg/kg succinylcholine in 4 ml normal saline [NS]); a high dose (HD) group (0.04 mg/kg succinylcholine in 4 ml NS); a placebo group (4 ml NS); and no intervention group. To measure the jaw occlusive power, 1 kg weight was hung sequentially on a specifically designed device on the animal's lower jaw. At -4, -2, 0', +2, +4, +6, +8, +10, +20, and +30 min, we measured the jaw occlusive power, oxygen saturation (SpO 2 ), and end-tidal carbon dioxide (ETCO 2 ).
RESULTS


After SMP, jaw occlusive power began to decline in CD and HD group. The arithmetical mean jaw occlusive power values at -4, -2, 0', +2, +4, +6, +8, and +10 min were 9.7, 9.7, 9.7, 8.7, 8.3, 7.3, 6.7, and 6.3 kgw in the CD group and 9.7, 9.3, 8.7, 8.0, 6.7, 5.0, 5.0, and 5.3 kgw in the HD group. No abnormalities in SpO 2 or ETCO 2 were detected.
CONCLUSION


Jaw occlusive power was decreased after SMP with succinylcholine, without inducing respiratory complication.",2020,"No abnormalities in SpO 2 or ETCO 2 were detected.
",['12 male mongrel dogs aged 10-12 months and weighing 30-35 kg'],"['succinylcholine', 'neuromuscular blocker', 'neuromuscular blocking agents', 'placebo', 'succinylcholine in 4 ml normal saline [NS]); a high dose (HD) group (0.04 mg/kg succinylcholine']","['jaw occlusive power, oxygen saturation (SpO 2 ), and end-tidal carbon dioxide (ETCO 2 ', 'arithmetical mean jaw occlusive power values']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1269316', 'cui_str': 'Mixed breed dog'}, {'cui': 'C0012984', 'cui_str': 'Canis lupus familiaris'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient'}]","[{'cui': 'C0038627', 'cui_str': 'Succinylcholine'}, {'cui': 'C0027866', 'cui_str': 'Neuromuscular blocking agent'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517407', 'cui_str': '0.04'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}]","[{'cui': 'C0022359', 'cui_str': 'Jaw'}, {'cui': 'C1947917', 'cui_str': 'Occluded'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.191738,"No abnormalities in SpO 2 or ETCO 2 were detected.
","[{'ForeName': 'Sion', 'Initials': 'S', 'LastName': 'Jo', 'Affiliation': 'Department of Emergency Medicine, Chonbuk National University Hospital; Research Institute of Clinical Medicine of Chonbuk National University and Biomedical Research Institute of Chonbuk National University Hospital, Jeonju-si, Korea.'}, {'ForeName': 'Jae Baek', 'Initials': 'JB', 'LastName': 'Lee', 'Affiliation': 'Research Institute of Clinical Medicine of Chonbuk National University and Biomedical Research Institute of Chonbuk National University Hospital; Department of Emergency Medicine, Chonbuk National University, Jeonju-si, Korea.'}, {'ForeName': 'Youngho', 'Initials': 'Y', 'LastName': 'Jin', 'Affiliation': 'Department of Emergency Medicine, Chonbuk National University, Jeonju-si, Korea.'}, {'ForeName': 'Taeoh', 'Initials': 'T', 'LastName': 'Jeong', 'Affiliation': 'Department of Emergency Medicine, Chonbuk National University, Jeonju-si, Korea.'}, {'ForeName': 'Jae Chol', 'Initials': 'JC', 'LastName': 'Yoon', 'Affiliation': 'Department of Emergency Medicine, Chonbuk National University, Jeonju-si, Korea.'}, {'ForeName': 'Boyoung', 'Initials': 'B', 'LastName': 'Park', 'Affiliation': 'National Cancer Center, National Cancer Control Institute, Goyang-si, Kyunggi-do, Korea.'}]",Indian journal of pharmacology,['10.4103/ijp.IJP_569_18']
1541,33078913,Efficacy of Zhu's acupuncture techniques to improve muscle strength of motion limbs in stroke patients.,"AIM


To investigate the efficacy of Zhu acupuncture in motoric ability improvement of stroke patients. This research is a preliminary study in an effort to test the efficacy of Zhu's acupuncture technique in motor improvement in stroke patients.
METHODS


This quasi-experimental study, with the pretest and posttest approach without control group design was conducted from June to December 2019 at Holistica Medical Centre Complementary Clinic Palembang, Indonesia. Manual Muscle Testing (MMT) was used before and after the intervention. Zhu's acupuncture was given five times a week for four weeks. Results Eight patients (four males and four females), who were in the recovery phase (within a period of recovery less than 1 year) after stroke attack were involved. Seven patients experienced improvements in mild and moderate grades for shoulder joint movement after the intervention. Regarding the elbow joint movement, the majority of patients (seven) experienced mild and moderate improvements. Of the total patients who experienced improvement, the majority had mild grade improvements. Conclusion Zhu's acupuncture technique was effective in improving muscle strength of motion limbs on stroke patients.",2021,Seven patients experienced improvements in mild and moderate grades for shoulder joint movement after the intervention.,"['June to December 2019 at Holistica Medical Centre Complementary Clinic Palembang, Indonesia', 'stroke patients']","['Manual Muscle Testing (MMT', 'acupuncture', ""Zhu's acupuncture technique"", 'acupuncture technique', 'Zhu acupuncture', ""Zhu's acupuncture techniques""]","['muscle strength of motion limbs', 'shoulder joint movement']","[{'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0021247', 'cui_str': 'Indonesia'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0451362', 'cui_str': 'Oxford grading scale for muscle strength'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0575545', 'cui_str': 'Shoulder joint - range of movement'}]",8.0,0.0239002,Seven patients experienced improvements in mild and moderate grades for shoulder joint movement after the intervention.,"[{'ForeName': 'Indri', 'Initials': 'I', 'LastName': 'Seta Septadina', 'Affiliation': 'Department of Anatomy, Faculty of Medicine Universitas Sriwijaya, Indonesia.'}, {'ForeName': 'Erial', 'Initials': 'E', 'LastName': 'Bahar', 'Affiliation': 'Department of Anatomy, Faculty of Medicine Universitas Sriwijaya, Indonesia.'}]","Medicinski glasnik : official publication of the Medical Association of Zenica-Doboj Canton, Bosnia and Herzegovina",['10.17392/1152-21']
1542,33078917,Does low intensity direct current affect open fracture wound healing?,"Aim To explore the effects of a molecular pathway from the application of low-intensity direct current (LIDC) for wound healing through the pathway signalling growth factor and initiation of fibroblast activation. Methods This randomized clinical trial included 32 patients with open fracture wounds who came to Hasan Sadikin Hospital in Bandung, Indonesia. The patients were divided in the control and the treatment group. Extensive assessment of wound contractions, FGF2 and FGF7 levels, and fibroblast expression were evaluated before and after the treatment. Results This study showed a better wound area repair in the treatment group than the standard group, 3.17±0.11 and 0.78±0.07, respectively. The increase of FGF-2 level (42.69±3.5 and 15.09±1.8, respectively), FGF-7 level (42.99±3.55 and 14.67±1.9, respectively), and fibroblast group expression (7.62±0.79 and 3.54±0.6, respectively) were found to be higher in the treatment group (p <0.05). Conclusion Low-intensity direct current accelerates wound healing through the increase of growth factor and fibroblast activation.",2021,"Extensive assessment of wound contractions, FGF2 and FGF7 levels, and fibroblast expression were evaluated before and after the treatment.","['32 patients with open fracture wounds who came to Hasan Sadikin Hospital in Bandung, Indonesia']",['low-intensity direct current (LIDC'],"['wound contractions, FGF2 and FGF7 levels, and fibroblast expression', 'wound area repair', 'FGF-7 level', 'growth factor and fibroblast activation', 'FGF-2 level', 'fibroblast group expression']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0016662', 'cui_str': 'Fracture, open'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0205115', 'cui_str': 'Afferent'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0021247', 'cui_str': 'Indonesia'}]","[{'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0442831', 'cui_str': 'Direct current'}]","[{'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0380603', 'cui_str': 'Fibroblast Growth Factor-2'}, {'cui': 'C1565802', 'cui_str': 'FGF7 protein, human'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0016030', 'cui_str': 'Fibroblast'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0018284', 'cui_str': 'Growth factor'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]",32.0,0.0234897,"Extensive assessment of wound contractions, FGF2 and FGF7 levels, and fibroblast expression were evaluated before and after the treatment.","[{'ForeName': 'Yoyos', 'Initials': 'Y', 'LastName': 'Dias Ismiarto', 'Affiliation': 'Department of Orthopaedics and Traumatology, Faculty of Medicine, Universitas Padjadjaran, Indonesia.'}, {'ForeName': 'Kemas Abdul', 'Initials': 'KA', 'LastName': 'Mutholib Luthfi', 'Affiliation': 'Department of Orthopaedics and Traumatology, Faculty of Medicine, Universitas Padjadjaran, Indonesia.'}, {'ForeName': 'Mahyudin', 'Initials': 'M', 'LastName': 'Mahyudin', 'Affiliation': 'Department of Orthopaedics and Traumatology, Faculty of Medicine, Universitas Padjadjaran, Indonesia.'}, {'ForeName': 'Adriel', 'Initials': 'A', 'LastName': 'Benedict', 'Affiliation': 'Department of Orthopaedics and Traumatology, Faculty of Medicine, Universitas Padjadjaran, Indonesia.'}]","Medicinski glasnik : official publication of the Medical Association of Zenica-Doboj Canton, Bosnia and Herzegovina",['10.17392/1241-21']
1543,33078961,System providing automated feedback improves task learning outcomes during child restraint system (CRS) installations.,"OBJECTIVES


The objective was to build and test an automated, interactive educational system to teach adults how to install a child restraint system (CRS) into a vehicle seat.
METHODS


The automated feedback system (AFS) consisted of a mockup vehicle fixture, convertible CRS, and doll. Sensors were implemented into the equipment so that forward-facing (FF) CRS installation errors could be detected. An interactive display monitor guided users through the CRS installation process and alerted them when steps were done incorrectly. Sixty adult volunteers were recruited and randomized into either the treatment group or the control group. The treatment group used the AFS to guide them through a practice installation. The control group also completed a practice installation using the same equipment fixture without the feedback feature turned on; they only had standard printed instruction manuals to guide their tasks. Then, participants from both groups completed a second CRS installation in a real vehicle with standard instruction manuals only. The frequencies and types of errors in all the installations were evaluated by a Child Passenger Safety Technician (CPST). Error rates were compared between the treatment and control groups using lower-tailed t-tests and Pearson's chi-square tests. Error rates were evaluated considering minor and serious errors together and also considering serious errors alone.
RESULTS


Compared to the control group, participants who trained with the AFS exhibited fewer overall errors (minor and serious) in their fixture installations (p < 0.0001) as well as their follow-up vehicle installations (p < 0.0001). Specifically, participants in the treatment group had fewer errors in choosing an installation method, locking the seat belt (SB), tightening the SB or lower anchors (LA), and tightening the harness (p = 0.0002, p = 0.0003, p = 0.0084, and p = 0.0098, respectively, compared to control group during follow-up vehicle installations). The treatment group also performed significantly better than the control group when only serious errors were considered.
CONCLUSIONS


An automated feedback system is an effective way to teach basic CRS installation skills to users.",2020,"Compared to the control group, participants who trained with the AFS exhibited fewer overall errors (minor and serious) in their fixture installations (p < 0.0001) as well as their follow-up vehicle installations (p < 0.0001).","['Sixty adult volunteers', 'child restraint system (CRS) installations']","['System providing automated feedback', 'practice installation using the same equipment fixture without the feedback feature turned on; they only had standard printed instruction manuals to guide their tasks']","['overall errors', 'Error rates', 'errors in choosing an installation method, locking the seat belt (SB), tightening the SB or lower anchors (LA), and tightening the harness', 'task learning outcomes']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C2718030', 'cui_str': 'Child Restraint Systems'}]","[{'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0014672', 'cui_str': 'Equipment'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0541749', 'cui_str': 'Does turn'}, {'cui': 'C0033161', 'cui_str': 'Printing'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0036498', 'cui_str': 'Seat belt'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1293132', 'cui_str': 'Anchoring'}, {'cui': 'C3873748', 'cui_str': 'Harness'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",60.0,0.0470091,"Compared to the control group, participants who trained with the AFS exhibited fewer overall errors (minor and serious) in their fixture installations (p < 0.0001) as well as their follow-up vehicle installations (p < 0.0001).","[{'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Mansfield', 'Affiliation': 'Injury Biomechanics Research Center, School of Health and Rehabilitation Sciences, The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Bolte', 'Affiliation': 'Injury Biomechanics Research Center, School of Health and Rehabilitation Sciences, The Ohio State University, Columbus, Ohio.'}]",Traffic injury prevention,['10.1080/15389588.2020.1829607']
1544,33078978,Carboplatin and Paclitaxel for Advanced Endometrial Cancer: Final Overall Survival and Adverse Event Analysis of a Phase III Trial (NRG Oncology/GOG0209).,"PURPOSE


Limitations of the paclitaxel-doxorubicin-cisplatin (TAP) regimen in the treatment of endometrial cancer include tolerability and cumbersome scheduling. The Gynecologic Oncology Group studied carboplatin plus paclitaxel (TC) as a noninferior alternative to TAP.
METHODS


GOG0209 was a phase III, randomized, noninferiority, open-label trial. Inclusion criteria were stage III, stage IV, and recurrent endometrial cancers; performance status 0-2; and adequate renal, hepatic, and marrow function. Prior radiotherapy and/or hormonal therapy were permitted, but chemotherapy, including radiosensitization, was not. Patients were treated with doxorubicin 45 mg/m 2  and cisplatin 50 mg/m 2  (day 1), followed by paclitaxel 160 mg/m 2  (day 2) with granulocyte colony-stimulating factor or paclitaxel 175 mg/m 2  and carboplatin area under the curve 6 (day 1) every 21 days for seven cycles. The primary endpoint was overall survival (OS; modified intention to treat). Progression-free survival (PFS), health-related quality of life (HRQoL), and toxicity were secondary endpoints.
RESULTS


From 2003 to 2009, 1,381 women were enrolled. Noninferiority of TC to TAP was concluded for OS (median, 37  v  41 months, respectively; hazard ratio [HR], 1.002; 90% CI, 0.9 to 1.12), and PFS (median, 13  v  14 months; HR, 1.032; 90% CI, 0.93 to 1.15). Neutropenic fever was reported in 7% of patients receiving TAP and 6% of those receiving TC. Grade > 2 sensory neuropathy was recorded in 26% of patients receiving TAP and 20% receiving TC ( P  = .40). More grade ≥ 3 thrombocytopenia (23%  v  12%), vomiting (7%  v  4%), diarrhea (6%  v  2%), and metabolic (14%  v  8%) toxicities were reported with TAP. Neutropenia (52%  v  80%) was more common with TC. Small HRQoL differences favored TC.
CONCLUSION


With demonstrated noninferiority to TAP, TC is the global first-line standard for advanced endometrial cancer.",2020,Grade > 2 sensory neuropathy was recorded in 26% of patients receiving TAP and 20% receiving TC ( P  = .40).,"['From 2003 to 2009, 1,381 women were enrolled', 'Advanced Endometrial Cancer', 'Inclusion criteria were stage III, stage IV, and recurrent endometrial cancers; performance status 0-2; and adequate renal, hepatic, and marrow function']","['Carboplatin and Paclitaxel', 'carboplatin plus paclitaxel (TC', 'TC to TAP', 'paclitaxel 160 mg/m 2  (day 2) with granulocyte colony-stimulating factor or paclitaxel 175 mg/m 2  and carboplatin', 'paclitaxel-doxorubicin-cisplatin (TAP', 'Prior radiotherapy and/or hormonal therapy', 'doxorubicin 45 mg/m 2  and cisplatin']","['Progression-free survival (PFS), health-related quality of life (HRQoL), and toxicity', 'diarrhea', 'PFS', 'Neutropenia', 'overall survival (OS; modified intention to treat', 'grade ≥ 3 thrombocytopenia', 'Neutropenic fever', 'vomiting', 'Grade > 2 sensory neuropathy', 'toxicities']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007103', 'cui_str': 'Endometrial neoplasms malignant'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4'}, {'cui': 'C0278802', 'cui_str': 'Endometrial cancer recurrent'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}]","[{'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0079459', 'cui_str': 'Colony-stimulating factor, granulocytic'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0151313', 'cui_str': 'Sensory neuropathy'}]",1381.0,0.0759159,Grade > 2 sensory neuropathy was recorded in 26% of patients receiving TAP and 20% receiving TC ( P  = .40).,"[{'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Miller', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Virginia L', 'Initials': 'VL', 'LastName': 'Filiaci', 'Affiliation': 'NRG Oncology, Clinical Trial Development Division, Biostatistics and Bioinformatics, Roswell Park Comprehensive Cancer Center, Buffalo, NY.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Mannel', 'Affiliation': 'The Peggy and Charles Stephenson Cancer Center, The University of Oklahoma Health Sciences Center, Oklahoma City, OK.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Cohn', 'Affiliation': 'Arthur G. James Cancer Hospital and Solove Research Institute, Ohio State University, Columbus, OH.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Matsumoto', 'Affiliation': 'Ehime University School of Medicine, Ehime, Japan.'}, {'ForeName': 'Krishnansu S', 'Initials': 'KS', 'LastName': 'Tewari', 'Affiliation': 'Division of Obstetrics and Gynecology, University of California, Irvine Medical Center, Orange, CA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'DiSilvestro', 'Affiliation': 'Women and Infants Hospital, Providence, RI.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Pearl', 'Affiliation': 'Stony Brook University Hospital, Stony Brook, NY.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Argenta', 'Affiliation': 'University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Matthew A', 'Initials': 'MA', 'LastName': 'Powell', 'Affiliation': 'Gynecologic Oncology, Washington University School of Medicine, St Louis, MO.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Zweizig', 'Affiliation': 'University of Massachusetts Memorial Medical Center, Worcester, MA.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Warshal', 'Affiliation': 'Cooper Hospital/University Medical Center, Camden, NJ.'}, {'ForeName': 'Parviz', 'Initials': 'P', 'LastName': 'Hanjani', 'Affiliation': 'Hanjani Institute for Gynecologic Oncology, Abington Memorial Hospital, Abington, PA.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Carney', 'Affiliation': 'John A. Burns School of Medicine, University of Hawaii Cancer Center, Honolulu, HI.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Huang', 'Affiliation': 'NRG Oncology, Clinical Trial Development Division, Biostatistics and Bioinformatics, Roswell Park Comprehensive Cancer Center, Buffalo, NY.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cella', 'Affiliation': 'Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Zaino', 'Affiliation': 'Penn State University, Hershey, PA.'}, {'ForeName': 'Gini F', 'Initials': 'GF', 'LastName': 'Fleming', 'Affiliation': 'The University of Chicago Medicine, Chicago, IL.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.01076']
1545,33079009,Radiofrequency Ablation vs Electrocautery Blinded Randomized Trial: Impact on Clinically Meaningful Outcomes.,"OBJECTIVE


To analyze patients' return to normal activity, pain scores, narcotic use, and adverse events after undergoing tonsillectomy or adenotonsillectomy with monopolar electrocautery or radiofrequency ablation.
STUDY DESIGN


Randomized double-blinded clinical trial based on prospective parallel design.
SETTING


Academic medical center and tertiary children's hospital between March 2018 and July 2019.
METHODS


Inclusion criteria included patients aged ≥3 years with surgical indication of recurrent tonsillitis or airway obstruction/sleep-disordered breathing. Patients were randomly assigned to monopolar electrocautery or radiofrequency ablation. Patients were blinded to treatment assignment. Survey questions answered via text or email were collected daily until postoperative day 15. The primary outcome was the patient's return to normal activity. Secondary outcomes included daily pain score, total amount of postoperative narcotic use, and adverse events.
RESULTS


Of the 236 patients who met inclusion criteria and were randomly assigned to radiofrequency ablation or monopolar electrocautery, 230 completed the study (radiofrequency ablation, n = 112; monopolar electrocautery, n = 118). There was no statistically significant difference between the groups in the number of days for return to normal activity ( P  = .89), daily pain scores over 15 postoperative days ( P  = .46), postoperative narcotic use ( P  = .61), or return to hospital for any reason ( P  = .60), including bleeding as an adverse event ( P  = .13).
CONCLUSIONS


As one of the largest randomized controlled trials examining instrumentation in tonsillectomy, our data do not show a difference between monopolar electrocautery and radiofrequency ablation with regard to return to normal activity, daily pain scores, total postoperative narcotic use, or adverse events.",2020,"There was no statistically significant difference between the groups in the number of days for return to normal activity ( P  = .89), daily pain scores over 15 postoperative days ( P  = .46), postoperative narcotic use ( P  = .61), or return to hospital for any reason ( P  = .60), including bleeding as an adverse event ( P  = .13).
","[""Academic medical center and tertiary children's hospital between March 2018 and July 2019"", 'Inclusion criteria included patients aged ≥3 years with surgical indication of recurrent tonsillitis or airway obstruction/sleep-disordered breathing', '236 patients who met inclusion criteria']","['monopolar electrocautery or radiofrequency ablation', 'tonsillectomy or adenotonsillectomy with monopolar electrocautery or radiofrequency ablation', 'monopolar electrocautery and radiofrequency ablation', 'Radiofrequency Ablation', 'radiofrequency ablation or monopolar electrocautery']","['daily pain score, total amount of postoperative narcotic use, and adverse events', 'bleeding as an adverse event', ""patient's return to normal activity"", 'number of days for return to normal activity', 'daily pain scores', 'normal activity, pain scores, narcotic use, and adverse events', 'postoperative narcotic use', 'normal activity, daily pain scores, total postoperative narcotic use, or adverse events']","[{'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0740402', 'cui_str': 'Tonsillitis recurrent'}, {'cui': 'C0001883', 'cui_str': 'Respiratory obstruction'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}]","[{'cui': 'C0013804', 'cui_str': 'Electrocoagulation'}, {'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}, {'cui': 'C0040423', 'cui_str': 'Tonsillectomy'}, {'cui': 'C0193959', 'cui_str': 'Tonsillectomy and adenoidectomy'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0027415', 'cui_str': 'Narcotic'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",,0.225359,"There was no statistically significant difference between the groups in the number of days for return to normal activity ( P  = .89), daily pain scores over 15 postoperative days ( P  = .46), postoperative narcotic use ( P  = .61), or return to hospital for any reason ( P  = .60), including bleeding as an adverse event ( P  = .13).
","[{'ForeName': 'Aaron J', 'Initials': 'AJ', 'LastName': 'Prussin', 'Affiliation': 'Division of Otolaryngology, University of Utah Health, Salt Lake City, Utah, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Babajanian', 'Affiliation': 'Division of Otolaryngology, University of Utah Health, Salt Lake City, Utah, USA.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Error', 'Affiliation': 'Division of Otolaryngology, University of Utah Health, Salt Lake City, Utah, USA.'}, {'ForeName': 'J Fredrik', 'Initials': 'JF', 'LastName': 'Grimmer', 'Affiliation': 'Division of Otolaryngology, University of Utah Health, Salt Lake City, Utah, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Ku', 'Affiliation': 'Division of Otolaryngology, University of Utah Health, Salt Lake City, Utah, USA.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'McRae', 'Affiliation': 'Division of Otolaryngology, University of Utah Health, Salt Lake City, Utah, USA.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Meier', 'Affiliation': 'Division of Otolaryngology, University of Utah Health, Salt Lake City, Utah, USA.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Thiesset', 'Affiliation': 'Department of Surgery, University of Utah Health, Salt Lake City, Utah, USA.'}, {'ForeName': 'Jonathan R', 'Initials': 'JR', 'LastName': 'Skirko', 'Affiliation': 'Division of Otolaryngology, University of Utah Health, Salt Lake City, Utah, USA.'}]",Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery,['10.1177/0194599820964737']
1546,33079066,"Intervention to Improve Preschool Children's Fundamental Motor Skills: Protocol for a Parent-Focused, Mobile App-Based Comparative Effectiveness Trial.","BACKGROUND


Preschool age is an important time to master fundamental motor skills (FMS) through structured physical activity, yet many young children lag behind in motor skill development.
OBJECTIVE


The Promoting Lifelong Activity in Youth (PLAY) study is a pilot comparative effectiveness trial to test the acceptability, feasibility, and preliminary effectiveness of a mobile app delivered to parents to promote FMS development in their preschool children (aged 3-5 years).
METHODS


We conducted a 2-arm, parallel-design, randomized comparative effectiveness trial in 72 parent-child dyads from the southeastern United States. Experts in motor development and developmental psychology developed an app designed to deliver a 12-week program to parents of preschoolers using 1 of 2 curricula: an FMS program (intervention) that involved peer modeling, parent engagement, and structured skills-based activities and an unstructured physical activity (comparator) curriculum that provided suggestions for child-led physical activity (ie, free play). Primary outcomes are feasibility and acceptability of the app and child's FMS measured at end of intervention (week 12). Exploratory outcomes are child's objective physical activity, perceived movement competence, and parent report of self-regulation at the end of treatment (week 12) and sustained outcomes at follow-up (week 24).
RESULTS


This project was funded in September 2018, with institutional review board approval in August 2018. Data collection took place from May 2019 through February 2020. To date, the project team has completed data collection on 69 preschool-age children, and results are expected to be published by 2021.
CONCLUSIONS


The PLAY study examines the feasibility and preliminary effectiveness of a mobile app, parent-led curricula to promote FMS proficiency for preschool children. If found to be effective, the app has the potential for wide-scale dissemination to parents of preschoolers and to provide a model for the utilization of mobile apps to promote young children's motor skill development.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03901300; https://clinicaltrials.gov/ct2/show/NCT03901300.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/19943.",2020,"Experts in motor development and developmental psychology developed an app designed to deliver a 12-week program to parents of preschoolers using 1 of 2 curricula: an FMS program (intervention) that involved peer modeling, parent engagement, and structured skills-based activities and an unstructured physical activity (comparator) curriculum that provided suggestions for child-led physical activity (ie, free play).","['preschool children (aged 3-5 years', 'preschool children', '72 parent-child dyads from the southeastern United States', '69 preschool-age children']","['mobile app, parent-led curricula', 'FMS program (intervention) that involved peer modeling, parent engagement, and structured skills-based activities and an unstructured physical activity (comparator) curriculum that provided suggestions for child-led physical activity (ie, free play', 'mobile app delivered to parents to promote FMS development']","[""child's objective physical activity, perceived movement competence, and parent report of self-regulation"", ""feasibility and acceptability of the app and child's FMS""]","[{'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0442758', 'cui_str': '3/5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C0026612', 'cui_str': 'Motor Skills'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0038659', 'cui_str': 'Suggestion'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0026612', 'cui_str': 'Motor Skills'}]",,0.0622129,"Experts in motor development and developmental psychology developed an app designed to deliver a 12-week program to parents of preschoolers using 1 of 2 curricula: an FMS program (intervention) that involved peer modeling, parent engagement, and structured skills-based activities and an unstructured physical activity (comparator) curriculum that provided suggestions for child-led physical activity (ie, free play).","[{'ForeName': 'E Kipling', 'Initials': 'EK', 'LastName': 'Webster', 'Affiliation': 'Institute of Public and Preventive Health, Augusta University, Augusta, GA, United States.'}, {'ForeName': 'Chelsea L', 'Initials': 'CL', 'LastName': 'Kracht', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, United States.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Newton', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, United States.'}, {'ForeName': 'Robbie A', 'Initials': 'RA', 'LastName': 'Beyl', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, United States.'}, {'ForeName': 'Amanda E', 'Initials': 'AE', 'LastName': 'Staiano', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, United States.'}]",JMIR research protocols,['10.2196/19943']
1547,33079070,Health-Related Quality of Life Improvements in Systemic Lupus Erythematosus Derived from a Digital Therapeutic Plus Tele-Health Coaching Intervention: Randomized Controlled Pilot Trial.,"BACKGROUND


Systemic lupus erythematosus (SLE), a systemic autoimmune disease with no known cure, remains poorly understood and patients suffer from many gaps in care. Recent work has suggested that dietary and other lifestyle factors play an important role in triggering and propagating SLE in some susceptible individuals. However, the magnitude of influence of these triggers, how to identify pertinent triggers in individual patients, and whether removing these triggers confers clinical benefit is unknown.
OBJECTIVE


To demonstrate that a digital therapeutic intervention, utilizing a mobile app that allows self-tracking of dietary, environmental, and lifestyle triggers, paired with telehealth coaching, added to usual care, improves quality of life in patients with SLE compared with usual care alone.
METHODS


In this randomized controlled pilot study, adults with SLE were assigned to a 16-week digital therapeutic intervention plus usual care or usual care alone. Primary outcome measures were changes from baseline to 16 weeks on 3 validated health-related quality of life (HRQoL) tools: Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Brief Pain Inventory-Short Form (BPI-SF), and Lupus Quality of Life (LupusQoL).
RESULTS


A total of 50 patients were randomized (23 control, 27 intervention). In per-protocol analysis, the intervention group achieved significantly greater improvement than the control group in 9 of 11 domains: FACIT-F (34% absolute improvement for the intervention group vs -1% for the control group, P<.001), BPI-SF-Pain Interference (25% vs 0%, P=.02), LupusQoL-Planning (17% vs 0%, P=.004), LupusQoL-Pain (13% vs 0%, P=.004), LupusQoL-Emotional Health (21% vs 4%, P=.02), and LupusQoL-Fatigue (38% vs 13%, P<.001) were significant when controlling for multiple comparisons; BPI-SF-Pain Severity (13% vs -6%, P=.049), LupusQoL-Physical Health (17% vs 3%, P=.049), and LupusQoL-Burden to Others (33% vs 4%, P=.04) were significant at an unadjusted 5% significance level.
CONCLUSIONS


A digital therapeutic intervention that pairs self-tracking with telehealth coaching to identify and remove dietary, environmental, and lifestyle symptom triggers resulted in statistically significant, clinically meaningful improvements in HRQoL when added to usual care in patients with SLE.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03426384; https://clinicaltrials.gov/ct2/show/NCT03426384.",2020,"In per-protocol analysis, the intervention group achieved significantly greater improvement than the control group in 9 of 11 domains: FACIT-F (34% absolute improvement for the intervention group vs -1% for the control group, P<.001), BPI-SF-Pain Interference (25% vs 0%, P=.02), LupusQoL-Planning (17% vs 0%, P=.004), LupusQoL-Pain (13% vs 0%, P=.004), LupusQoL-Emotional Health (21% vs 4%, P=.02), and LupusQoL-Fatigue (38% vs 13%, P<.001) were significant when controlling for multiple comparisons; BPI-SF-Pain Severity (13% vs -6%, P=.049), LupusQoL-Physical Health (17% vs 3%, P=.049), and LupusQoL-Burden to Others (33% vs 4%, P=.04) were significant at an unadjusted 5% significance level.
","['patients with SLE compared with usual care alone', 'adults with SLE', 'Systemic Lupus Erythematosus', '50 patients', 'patients with SLE']","['digital therapeutic intervention plus usual care or usual care alone', 'Digital Therapeutic Plus Tele-Health Coaching Intervention']","['LupusQoL-Fatigue', 'multiple comparisons; BPI-SF-Pain Severity', 'LupusQoL-Emotional Health', 'LupusQoL-Pain', 'LupusQoL-Planning', 'LupusQoL-Physical Health', '3 validated health-related quality of life (HRQoL) tools: Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Brief Pain Inventory-Short Form (BPI-SF), and Lupus Quality of Life (LupusQoL', 'quality of life', 'BPI-SF-Pain Interference']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024141', 'cui_str': 'Systemic lupus erythematosus'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1515258', 'cui_str': 'Telephone number (property)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0024131', 'cui_str': 'Lupus vulgaris'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}]",50.0,0.175888,"In per-protocol analysis, the intervention group achieved significantly greater improvement than the control group in 9 of 11 domains: FACIT-F (34% absolute improvement for the intervention group vs -1% for the control group, P<.001), BPI-SF-Pain Interference (25% vs 0%, P=.02), LupusQoL-Planning (17% vs 0%, P=.004), LupusQoL-Pain (13% vs 0%, P=.004), LupusQoL-Emotional Health (21% vs 4%, P=.02), and LupusQoL-Fatigue (38% vs 13%, P<.001) were significant when controlling for multiple comparisons; BPI-SF-Pain Severity (13% vs -6%, P=.049), LupusQoL-Physical Health (17% vs 3%, P=.049), and LupusQoL-Burden to Others (33% vs 4%, P=.04) were significant at an unadjusted 5% significance level.
","[{'ForeName': 'Faiz', 'Initials': 'F', 'LastName': 'Khan', 'Affiliation': 'EVP, CityMD, Dix Hills, NY, United States.'}, {'ForeName': 'Nora', 'Initials': 'N', 'LastName': 'Granville', 'Affiliation': 'Independent Researcher, New York, NY, United States.'}, {'ForeName': 'Raja', 'Initials': 'R', 'LastName': 'Malkani', 'Affiliation': 'Independent Researcher, Austin, TX, United States.'}, {'ForeName': 'Yash', 'Initials': 'Y', 'LastName': 'Chathampally', 'Affiliation': 'Harris Health, Houston, TX, United States.'}]",Journal of medical Internet research,['10.2196/23868']
1548,33079071,Smartphone App to Address Loneliness Among College Students: Pilot Randomized Controlled Trial.,"BACKGROUND


Loneliness is a widespread and significant problem on college campuses. Prolonged loneliness in young adulthood is a risk factor for concurrent and future mental health problems and attrition, making college a critical time for support. Cognitive and behavioral interventions show promise for decreasing loneliness and can be widely disseminated through technology.
OBJECTIVE


This pilot randomized controlled trial was conducted to examine the initial efficacy, feasibility, and desirability of a smartphone app, Nod, designed to deliver cognitive and behavioral skill-building exercises to reduce loneliness during the transition to college.
METHODS


First-year college students (N=221, mean age 18.7 years, 59% female) were recruited online during incoming student orientation, and randomized to either receive immediate access to Nod (experimental group, n=100) or access after 4 weeks (control group, n=121). The app delivered skills via fully automated (1) ""social challenges,"" suggested activities designed to build social connections; (2) reflections, brief cognitive reframing exercises; and (3) student testimonials that encouraged a growth mindset toward social connection building. Main intention-to-treat analyses were used to compare the conditions on self-assessed loneliness, depressive symptoms, and other mental health and college adjustment outcomes at week 4, controlling for baseline values on those variables. Analyses were also performed to test the hypothesis that the treatment benefits would be particularly pronounced for participants with heightened psychological vulnerability at baseline (ie, higher baseline depressive symptoms and loneliness).
RESULTS


Retention was 97% at week 4, and participants viewed an average 36.7 pages of app content. There were no significant condition differences in loneliness at week 4 (F 1, 211 =0.05, P=.82; η p 2  <.001). However, there was a significant condition-by-baseline depression interaction to predict week-4 loneliness (F 1,209 =9.65, P=.002; η p 2  =.04). Simple slope analyses indicated that baseline depression positively predicted week-4 loneliness among control participants (r=0.30, t 209 =3.81, P<.001), but not among experimental participants (r=-0.09, t 209 =-0.84, P=.40), suggesting that Nod buffered participants with high baseline depression scores from experiencing heightened midquarter loneliness. Similarly, there were no significant condition differences in other week-4 outcomes. However, moderation by baseline vulnerability was found for week-4 depressive symptoms, sleep quality, and indices of college adjustment (eg, perceived social support and campus belonging).
CONCLUSIONS


Although Nod exposure did not impact outcomes for the full sample, these results provide initial evidence of its benefit for vulnerable students. The results of this trial suggest that cognitive and behavioral skills delivered via a mobile app can buffer psychologically vulnerable college students against heightened loneliness and depressive symptoms, as well as other negative college adjustment outcomes. Future work will aim to improve upon app engagement, and to address loneliness among other key populations.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04164654; https://clinicaltrials.gov/ct2/show/NCT04164654.",2020,"Although Nod exposure did not impact outcomes for the full sample, these results provide initial evidence of its benefit for vulnerable students.","['College Students', 'First-year college students (N=221, mean age 18.7 years, 59% female']","['smartphone app, Nod, designed to deliver cognitive and behavioral skill-building exercises', 'skills via fully automated (1) ""social challenges,"" suggested activities designed to build social connections; (2) reflections, brief cognitive reframing exercises; and (3) student testimonials that encouraged a growth mindset toward social connection building']","['Prolonged loneliness', 'self-assessed loneliness, depressive symptoms, and other mental health and college adjustment outcomes', 'week-4 depressive symptoms, sleep quality, and indices of college adjustment (eg, perceived social support and campus belonging', 'loneliness']","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0085243', 'cui_str': 'Mouse, Inbred NOD'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0449379', 'cui_str': 'Connection'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0018270', 'cui_str': 'Growth'}]","[{'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0037438', 'cui_str': 'Social support'}]",,0.176522,"Although Nod exposure did not impact outcomes for the full sample, these results provide initial evidence of its benefit for vulnerable students.","[{'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Bruehlman-Senecal', 'Affiliation': 'Hopelab, San Francisco, CA, United States.'}, {'ForeName': 'Cayce J', 'Initials': 'CJ', 'LastName': 'Hook', 'Affiliation': 'Hopelab, San Francisco, CA, United States.'}, {'ForeName': 'Jennifer H', 'Initials': 'JH', 'LastName': 'Pfeifer', 'Affiliation': 'Department of Psychology, University of Oregon, Eugene, OR, United States.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'FitzGerald', 'Affiliation': 'Hopelab, San Francisco, CA, United States.'}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'Davis', 'Affiliation': 'Department of Psychology, University of Oregon, Eugene, OR, United States.'}, {'ForeName': 'Kevin L', 'Initials': 'KL', 'LastName': 'Delucchi', 'Affiliation': 'Department of Psychiatry and Weill Institute for Neurosciences, University of California, San Francisco, San Francisco, CA, United States.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Haritatos', 'Affiliation': 'Hopelab, San Francisco, CA, United States.'}, {'ForeName': 'Danielle E', 'Initials': 'DE', 'LastName': 'Ramo', 'Affiliation': 'Hopelab, San Francisco, CA, United States.'}]",JMIR mental health,['10.2196/21496']
1549,33079152,Effect of Vericiguat vs Placebo on Quality of Life in Patients With Heart Failure and Preserved Ejection Fraction: The VITALITY-HFpEF Randomized Clinical Trial.,"Importance


Patients with heart failure and preserved ejection fraction (HFpEF) are at high risk of mortality, hospitalizations, and reduced functional capacity and quality of life.
Objective


To assess the efficacy of the oral soluble guanylate cyclase stimulator vericiguat on the physical limitation score (PLS) of the Kansas City Cardiomyopathy Questionnaire (KCCQ).
Design, Setting, and Participants


Phase 2b randomized, double-blind, placebo-controlled, multicenter trial of 789 patients with chronic HFpEF and left ventricular ejection fraction 45% or higher with New York Heart Association class II-III symptoms, within 6 months of a recent decompensation (HF hospitalization or intravenous diuretics for HF without hospitalization), and with elevated natriuretic peptides, enrolled at 167 sites in 21 countries from June 15, 2018, through March 27, 2019; follow-up was completed on November 4, 2019.
Interventions


Patients were randomized to receive vericiguat, up-titrated to 15-mg (n = 264) or 10-mg (n = 263) daily oral dosages, compared with placebo (n = 262) and randomized 1:1:1.
Main Outcomes and Measures


The primary outcome was change in the KCCQ PLS (range, 0-100; higher values indicate better functioning) after 24 weeks of treatment. The secondary outcome was 6-minute walking distance from baseline to 24 weeks.
Results


Among 789 randomized patients, the mean age was 72.7 (SD, 9.4) years; 385 (49%) were female; mean EF was 56%; and median N-terminal pro-brain natriuretic peptide level was 1403 pg/mL; 761 (96.5%) completed the trial. The baseline and 24-week KCCQ PLS means for the 15-mg/d vericiguat, 10-mg/d vericiguat, and placebo groups were 60.0 and 68.3, 57.3 and 69.0, and 59.0 and 67.1, respectively, and the least-squares mean changes were 5.5, 6.4, and 6.9, respectively. The least-squares mean difference in scores between the 15-mg/d vericiguat and placebo groups was -1.5 (95% CI, -5.5 to 2.5; P = .47) and between the 10-mg/d vericiguat and placebo groups was -0.5 (95% CI, -4.6 to 3.5; P = .80). The baseline and 24-week 6-minute walking distance mean scores in the 15-mg/d vericiguat, 10-mg/d vericiguat, and placebo groups were 295.0 m and 311.8m , 292.1 m and 318.3 m, and 295.8 m and 311.4 m, and the least-squares mean changes were 5.0 m, 8.7 m, and 10.5 m, respectively. The least-squares mean difference between the 15-mg/d vericiguat and placebo groups was -5.5 m (95% CI, -19.7 m to 8.8 m; P = .45) and between the 10-mg/d vericiguat and placebo groups was -1.8 m (95% CI, -16.2 m to 12.6 m; P = .81), respectively. The proportions of patients who experienced symptomatic hypotension were 6.4% in the 15-mg/d vericiguat group, 4.2% in the 10-mg/d vericiguat group, and 3.4% in the placebo group; those with syncope were 1.5%, 0.8%, and 0.4%, respectively.
Conclusions and Relevance


Among patients with HFpEF and recent decompensation, 24-week treatment with vericiguat at either 15-mg/d or 10-mg/d dosages compared with placebo did not improve the physical limitation score of the KCCQ.
Trial Registration


ClinicalTrials.gov Identifier: NCT03547583.",2020,"The baseline and 24-week 6-minute walking distance mean scores in the 15-mg/d vericiguat, 10-mg/d vericiguat, and placebo groups were 295.0 m and 311.8m , 292.1 m and 318.3 m, and 295.8 m and 311.4 m, and the least-squares mean changes were 5.0 m, 8.7 m, and 10.5 m, respectively.","['patients with HFpEF and recent decompensation', 'Importance\n\n\nPatients with heart failure and preserved ejection fraction (HFpEF', '789 randomized patients', 'Patients With Heart Failure and Preserved Ejection Fraction', 'mean age was 72.7 (SD, 9.4) years; 385 (49%) were female; mean EF was 56%; and median N-terminal pro-brain natriuretic peptide level was 1403 pg/mL; 761 (96.5%) completed the trial', '789 patients with chronic HFpEF and left ventricular ejection fraction 45% or higher with New York Heart Association class II-III symptoms, within 6 months of a recent decompensation (HF hospitalization or intravenous diuretics for HF without hospitalization), and with elevated natriuretic peptides, enrolled at 167 sites in 21 countries from June 15, 2018, through March 27, 2019; follow-up was completed on November 4, 2019']","['vericiguat, up-titrated to 15-mg (n\u2009=\u2009264) or 10-mg (n\u2009=\u2009263) daily oral dosages, compared with placebo', 'placebo', 'oral soluble guanylate cyclase stimulator vericiguat', 'Vericiguat vs Placebo']","['physical limitation score', 'Quality of Life', '6-minute walking distance mean scores', 'KCCQ PLS', 'symptomatic hypotension', '6-minute walking distance', 'physical limitation score (PLS) of the Kansas City Cardiomyopathy Questionnaire (KCCQ']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0231187', 'cui_str': 'Decompensation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517751', 'cui_str': '385'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1533071', 'cui_str': 'N terminal pro-brain natriuretic peptide level'}, {'cui': 'C0439297', 'cui_str': 'ng/L'}, {'cui': 'C4517907', 'cui_str': '96.5'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0441886', 'cui_str': 'Class 2'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0012798', 'cui_str': 'Diuretic'}, {'cui': 'C1144709', 'cui_str': 'Natriuretic Peptide Hormones'}, {'cui': 'C4517595', 'cui_str': '167'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C4078709', 'cui_str': 'vericiguat'}, {'cui': 'C4517671', 'cui_str': '263'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1097411', 'cui_str': 'Nitric Oxide Receptors'}, {'cui': 'C0175727', 'cui_str': 'Stimulator'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0022497', 'cui_str': 'Kansas'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}]",789.0,0.376166,"The baseline and 24-week 6-minute walking distance mean scores in the 15-mg/d vericiguat, 10-mg/d vericiguat, and placebo groups were 295.0 m and 311.8m , 292.1 m and 318.3 m, and 295.8 m and 311.4 m, and the least-squares mean changes were 5.0 m, 8.7 m, and 10.5 m, respectively.","[{'ForeName': 'Paul W', 'Initials': 'PW', 'LastName': 'Armstrong', 'Affiliation': 'Division of Cardiology, Canadian VIGOUR Centre, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Carolyn S P', 'Initials': 'CSP', 'LastName': 'Lam', 'Affiliation': 'National Heart Centre of Singapore, Duke-National University of Singapore, Singapore.'}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Anstrom', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Ezekowitz', 'Affiliation': 'Division of Cardiology, Canadian VIGOUR Centre, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Adrian F', 'Initials': 'AF', 'LastName': 'Hernandez', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': ""O'Connor"", 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Burkert', 'Initials': 'B', 'LastName': 'Pieske', 'Affiliation': 'Charité University Medicine and German Heart Center, Berlin, Germany.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Ponikowski', 'Affiliation': 'Wroclaw Medical University, Wroclaw, Poland.'}, {'ForeName': 'Sanjiv J', 'Initials': 'SJ', 'LastName': 'Shah', 'Affiliation': 'Feinberg School of Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Adriaan A', 'Initials': 'AA', 'LastName': 'Voors', 'Affiliation': 'University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Lilin', 'Initials': 'L', 'LastName': 'She', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Vanja', 'Initials': 'V', 'LastName': 'Vlajnic', 'Affiliation': 'Bayer US, Whippany, New Jersey.'}, {'ForeName': 'Francine', 'Initials': 'F', 'LastName': 'Carvalho', 'Affiliation': 'Bayer SA-Brazil, São Paulo, Brazil.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Bamber', 'Affiliation': 'Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Robert O', 'Initials': 'RO', 'LastName': 'Blaustein', 'Affiliation': 'Merck & Co Inc, Kenilworth, New Jersey.'}, {'ForeName': 'Lothar', 'Initials': 'L', 'LastName': 'Roessig', 'Affiliation': 'Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Butler', 'Affiliation': 'University of Mississippi Medical Center, Jackson.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2020.15922']
1550,33079154,Effect of Praliciguat on Peak Rate of Oxygen Consumption in Patients With Heart Failure With Preserved Ejection Fraction: The CAPACITY HFpEF Randomized Clinical Trial.,"Importance


Heart failure with preserved ejection fraction (HFpEF) is often characterized by nitric oxide deficiency.
Objective


To evaluate the efficacy and adverse effects of praliciguat, an oral soluble guanylate cyclase stimulator, in patients with HFpEF.
Design, Setting, and Participants


CAPACITY HFpEF was a randomized, double-blind, placebo-controlled, phase 2 trial. Fifty-nine sites enrolled 196 patients with heart failure and an ejection fraction of at least 40%, impaired peak rate of oxygen consumption (peak V̇o2), and at least 2 conditions associated with nitric oxide deficiency (diabetes, hypertension, obesity, or advanced age). The trial randomized patients to 1 of 3 praliciguat dose groups or a placebo group, but was refocused early to a comparison of the 40-mg praliciguat dose vs placebo. Participants were enrolled from November 15, 2017, to April 30, 2019, with final follow-up on August 19, 2019.
Interventions


Patients were randomized to receive 12 weeks of treatment with 40 mg of praliciguat daily (n = 91) or placebo (n = 90).
Main Outcomes and Measures


The primary efficacy end point was the change from baseline in peak V̇o2 in patients who completed at least 8 weeks of assigned dosing. Secondary end points included the change from baseline in 6-minute walk test distance and in ventilatory efficiency (ventilation/carbon dioxide production slope). The primary adverse event end point was the incidence of treatment-emergent adverse events (TEAEs).
Results


Among 181 patients (mean [SD] age, 70 [9] years; 75 [41%] women), 155 (86%) completed the trial. In the placebo (n = 78) and praliciguat (n = 65) groups, changes in peak V̇o2 were 0.04 mL/kg/min (95% CI, -0.49 to 0.56) and -0.26 mL/kg/min (95% CI, -0.83 to 0.31), respectively; the placebo-adjusted least-squares between-group difference in mean change from baseline was -0.30 mL/kg/min ([95% CI, -0.95 to 0.35]; P = .37). None of the 3 prespecified secondary end points were statistically significant. In the placebo and praliciguat groups, changes in 6-minute walk test distance were 58.1 m (95% CI, 26.1-90.1) and 41.4 m (95% CI, 8.2-74.5), respectively; the placebo-adjusted least-squares between-group difference in mean change from baseline was -16.7 m (95% CI, -47.4 to 13.9). In the placebo and praliciguat groups, the placebo-adjusted least-squares between-group difference in mean change in ventilation/carbon dioxide production slope was -0.3 (95% CI, -1.6 to 1.0). There were more dizziness (9.9% vs 1.1%), hypotension (8.8% vs 0%), and headache (11% vs 6.7%) TEAEs with praliciguat compared with placebo. The frequency of serious TEAEs was similar between the groups (10% in the praliciguat group and 11% in the placebo group).
Conclusions and Relevance


Among patients with HFpEF, the soluble guanylate cyclase stimulator praliciguat, compared with placebo, did not significantly improve peak V̇o2 from baseline to week 12. These findings do not support the use of praliciguat in patients with HFpEF.
Trial Registration


ClinicalTrials.gov Identifier: NCT03254485.",2020,"In the placebo and praliciguat groups, changes in 6-minute walk test distance were 58.1 m (95% CI, 26.1-90.1) and 41.4 m (95% CI, 8.2-74.5), respectively; the placebo-adjusted least-squares between-group difference in mean change from baseline was -16.7 m (95% CI, -47.4 to 13.9).","['Patients With Heart Failure With Preserved Ejection Fraction', 'Fifty-nine sites enrolled 196 patients with heart failure and an ejection fraction of at least 40%, impaired peak rate of oxygen consumption (peak V̇o2), and at least 2 conditions associated with nitric oxide deficiency (diabetes, hypertension, obesity, or advanced age', '70 [9] years; 75 [41%] women), 155 (86%) completed the trial', 'Participants were enrolled from November 15, 2017, to April 30, 2019, with final follow-up on August 19, 2019', 'patients with HFpEF', '181 patients (mean [SD] age']","['preserved ejection fraction (HFpEF', '40-mg praliciguat dose vs placebo', 'HFpEF', 'placebo', 'Praliciguat']","['headache', 'hypotension', '6-minute walk test distance', '6-minute walk test distance and in ventilatory efficiency (ventilation/carbon dioxide production slope', 'dizziness', 'mean change in ventilation/carbon dioxide production slope', 'incidence of treatment-emergent adverse events (TEAEs', 'Peak Rate of Oxygen Consumption', 'frequency of serious TEAEs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2960127', 'cui_str': 'Heart failure with normal ejection fraction'}, {'cui': 'C3830128', 'cui_str': '59'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C2960127', 'cui_str': 'Heart failure with normal ejection fraction'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",196.0,0.757863,"In the placebo and praliciguat groups, changes in 6-minute walk test distance were 58.1 m (95% CI, 26.1-90.1) and 41.4 m (95% CI, 8.2-74.5), respectively; the placebo-adjusted least-squares between-group difference in mean change from baseline was -16.7 m (95% CI, -47.4 to 13.9).","[{'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Udelson', 'Affiliation': 'Division of Cardiology and the CardioVascular Center, Tufts Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Gregory D', 'Initials': 'GD', 'LastName': 'Lewis', 'Affiliation': 'Massachusetts General Hospital and Harvard Medical School, Boston.'}, {'ForeName': 'Sanjiv J', 'Initials': 'SJ', 'LastName': 'Shah', 'Affiliation': 'Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Zile', 'Affiliation': 'Medical University of South Carolina and the RHJ Department of Veterans Affairs Medical Center, Charleston.'}, {'ForeName': 'Margaret M', 'Initials': 'MM', 'LastName': 'Redfield', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Burnett', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Parker', 'Affiliation': 'Division of Cardiology, University Health Network, Mount Sinai Hospital, Toronto, Ontario.'}, {'ForeName': 'Jelena P', 'Initials': 'JP', 'LastName': 'Seferovic', 'Affiliation': 'Cyclerion Therapeutics, Cambridge, Massachusetts.'}, {'ForeName': 'Phebe', 'Initials': 'P', 'LastName': 'Wilson', 'Affiliation': 'Cyclerion Therapeutics, Cambridge, Massachusetts.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Mittleman', 'Affiliation': 'Ironwood Pharmaceuticals, Cambridge, Massachusetts.'}, {'ForeName': 'Albert T', 'Initials': 'AT', 'LastName': 'Profy', 'Affiliation': 'Cyclerion Therapeutics, Cambridge, Massachusetts.'}, {'ForeName': 'Marvin A', 'Initials': 'MA', 'LastName': 'Konstam', 'Affiliation': 'Division of Cardiology and the CardioVascular Center, Tufts Medical Center, Boston, Massachusetts.'}]",JAMA,['10.1001/jama.2020.16641']
1551,33079196,Changes in Cigarette Consumption With Reduced Nicotine Content Cigarettes Among Smokers With Psychiatric Conditions or Socioeconomic Disadvantage: 3 Randomized Clinical Trials.,"Importance


This study is part of a programmatic effort evaluating the effects of reducing nicotine content of cigarettes to minimally addictive levels.
Objective


To examine whether very low-nicotine-content (VLNC) cigarettes decrease smoking rates and dependence severity among smokers with psychiatric disorders or socioeconomic disadvantage.
Design, Setting, and Participants


These 3 randomized clinical trials were performed at the University of Vermont, Brown University, and Johns Hopkins University between October 2016 and September 2019. Participants received 12 weeks of exposure to study cigarettes with nicotine content ranging from levels representative of commercial cigarettes (15.8 mg nicotine/g tobacco) to less than a hypothesized addiction threshold (2.4 mg/g and 0.4 mg/g). Daily smokers from 3 at-risk populations participated: individuals with affective disorders, exemplifying smokers with mental illness; individuals with opioid use disorder, exemplifying smokers with substance use disorders; and women with high school educations or less, exemplifying smokers with socioeconomic disadvantage. Data were analyzed from September 2019 to July 2020.
Interventions


Random assignment to 1 of 3 study cigarettes provided weekly at no cost for 12 weeks.
Main Outcomes and Measures


The primary outcome was between-group differences in mean total cigarettes smoked daily (CPD) during week 12; secondary outcomes included CPD for study and nonstudy cigarettes and dependence severity across weeks analyzed using analysis of covariance, random coefficients growth modeling, or repeated measures analysis of variance.
Results


A total of 775 participants were included (mean [SD] age, 35.59 [11.05] years; 551 [71.10%] women [owing to 1 population being exclusively women]); participants smoked a mean (SD) of 17.79 (9.18) CPD at study intake. A total of 286 participants were randomized to 0.4 mg/g, 235 participants were randomized to 2.4 mg/g, and 254 participants were randomized to 15.8 mg/g. Participants randomized to VLNC cigarettes had decreased mean [SEM] total CPD during week 12 across populations (Cohen d = 0.61; P < .001). At week 12, mean (SEM) CPD decreased to 17.96 (0.98) CPD in the 0.4 mg/g group and to 19.53 (1.07) CPD in the 2.4 mg/g group, both of which were significantly different from the 15.8 mg/g group (25.08 [1.08] CPD at week 12) but not each other (0.4 mg/g adjusted mean difference: -7.54 [95%CI, -9.51 to -5.57]; 2.4 mg/g adjusted mean difference: -5.34 [95% CI, 7.41 to -3.26]). Several secondary outcomes differed across populations randomized to VLNCs, including mean total CPD across weeks, with linear trends lower in participants receiving 0.4 mg/g (-0.28 [95%CI, -0.39 to -0.18]; P < .001) and 2.4 mg/g (-0.13 [95%CI, -0.25 to -0.01]; P < .001) doses compared with those receiving the 15.8 mg/g dose (0.30 [95% CI, 0.19 to 0.41]). Fagerström Test of Nicotine Dependence mean total scores were significantly lower in participants who received VLNCs (Cohen d = 0.12; P < .001), with those who received the 0.4 mg/g dose (mean [SD] score, 3.99 [0.06]; P < .001 vs 15.8 mg/g) or 2.4 mg/g dose (mean [SD] score, 4.07 [0.06]; P = .01 vs 15.8 mg/g) differing from those who received the 15.8 mg/g dose (mean [SD] score, 4.31 [0.06]) but not from each other.
Conclusions and Relevance


These findings demonstrate that decreasing the nicotine content of cigarettes to very low levels reduced smoking rate and nicotine-dependence severity in these high-risk populations, effects that may facilitate successful cessation.
Trial Registration


ClinicalTrials.gov Identifiers: NCT02232737, NCT02250664, NCT02250534.",2020,"Fagerström Test of Nicotine Dependence mean total scores were significantly lower in participants who received VLNCs (Cohen d = 0.12; P < .001), with those who received the 0.4 mg/g dose (mean [SD] score, 3.99 [0.06]; P < .001 vs 15.8 mg/g) or 2.4 mg/","[' participants smoked a mean (SD) of 17.79 (9.18', 'Participants\n\n\nThese 3 randomized clinical trials were performed at the University of Vermont, Brown University, and Johns Hopkins University between October 2016 and September 2019', 'smokers with psychiatric disorders or socioeconomic disadvantage', '286 participants were randomized to 0.4 mg/g, 235 participants were randomized to 2.4 mg/g, and 254 participants', 'Smokers With Psychiatric Conditions or Socioeconomic Disadvantage', 'A total of 775 participants were included (mean [SD] age, 35.59 [11.05] years', '551 [71.10%] women [owing to 1 population being exclusively women', 'Daily smokers from 3 at-risk populations participated: individuals with affective disorders, exemplifying smokers with mental illness; individuals with opioid use disorder, exemplifying smokers with substance use disorders; and women with high school educations or less, exemplifying smokers with socioeconomic disadvantage']","['VLNC cigarettes', 'nicotine content ranging from levels representative of commercial cigarettes (15.8 mg nicotine/g tobacco', 'Nicotine Content Cigarettes', 'nicotine-content (VLNC) cigarettes']","['mean total CPD', 'CPD', 'mean total cigarettes smoked daily (CPD', 'Cigarette Consumption', 'mean (SEM) CPD', 'SEM] total CPD', 'Fagerström Test of Nicotine Dependence mean total scores', 'CPD for study and nonstudy cigarettes and dependence severity']","[{'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0042537', 'cui_str': 'Vermont'}, {'cui': 'C0155339', 'cui_str': ""Brown's tendon sheath syndrome""}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0037464', 'cui_str': 'Factors, Socioeconomic'}, {'cui': 'C4517457', 'cui_str': '0.4'}, {'cui': 'C1300563', 'cui_str': 'g/kg'}, {'cui': 'C4517631', 'cui_str': '2.4'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517874', 'cui_str': '775'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C3266136', 'cui_str': 'Smokes tobacco daily'}, {'cui': 'C0242444', 'cui_str': 'Populations at Risk'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0525045', 'cui_str': 'Mood disorder'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0455002', 'cui_str': 'Education and schooling detail'}]","[{'cui': 'C0442811', 'cui_str': 'Very low'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C5191316', 'cui_str': '15.8'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0055816', 'cui_str': 'citrate phosphate dextrose'}, {'cui': 'C0239059', 'cui_str': 'Cigarette smoke'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0459840', 'cui_str': 'Cigarette consumption'}, {'cui': 'C0262878', 'cui_str': 'Scanning electron microscope'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0028043', 'cui_str': 'Nicotine dependence'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0011546', 'cui_str': 'Dependency, Psychology'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",775.0,0.177412,"Fagerström Test of Nicotine Dependence mean total scores were significantly lower in participants who received VLNCs (Cohen d = 0.12; P < .001), with those who received the 0.4 mg/g dose (mean [SD] score, 3.99 [0.06]; P < .001 vs 15.8 mg/g) or 2.4 mg/","[{'ForeName': 'Stephen T', 'Initials': 'ST', 'LastName': 'Higgins', 'Affiliation': 'UVM Tobacco Center of Regulatory Science, University of Vermont, Burlington.'}, {'ForeName': 'Jennifer W', 'Initials': 'JW', 'LastName': 'Tidey', 'Affiliation': 'Center for Alcohol and Addiction Studies, Brown University, Providence, Rhode Island.'}, {'ForeName': 'Stacey C', 'Initials': 'SC', 'LastName': 'Sigmon', 'Affiliation': 'UVM Tobacco Center of Regulatory Science, University of Vermont, Burlington.'}, {'ForeName': 'Sarah H', 'Initials': 'SH', 'LastName': 'Heil', 'Affiliation': 'UVM Tobacco Center of Regulatory Science, University of Vermont, Burlington.'}, {'ForeName': 'Diann E', 'Initials': 'DE', 'LastName': 'Gaalema', 'Affiliation': 'UVM Tobacco Center of Regulatory Science, University of Vermont, Burlington.'}, {'ForeName': 'Dustin', 'Initials': 'D', 'LastName': 'Lee', 'Affiliation': 'Yale University Tobacco Center of Regulatory Science, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Hughes', 'Affiliation': 'UVM Tobacco Center of Regulatory Science, University of Vermont, Burlington.'}, {'ForeName': 'Andrea C', 'Initials': 'AC', 'LastName': 'Villanti', 'Affiliation': 'UVM Tobacco Center of Regulatory Science, University of Vermont, Burlington.'}, {'ForeName': 'Janice Y', 'Initials': 'JY', 'LastName': 'Bunn', 'Affiliation': 'UVM Tobacco Center of Regulatory Science, University of Vermont, Burlington.'}, {'ForeName': 'Danielle R', 'Initials': 'DR', 'LastName': 'Davis', 'Affiliation': 'UVM Tobacco Center of Regulatory Science, University of Vermont, Burlington.'}, {'ForeName': 'Cecilia L', 'Initials': 'CL', 'LastName': 'Bergeria', 'Affiliation': 'UVM Tobacco Center of Regulatory Science, University of Vermont, Burlington.'}, {'ForeName': 'Joanna M', 'Initials': 'JM', 'LastName': 'Streck', 'Affiliation': 'UVM Tobacco Center of Regulatory Science, University of Vermont, Burlington.'}, {'ForeName': 'Maria A', 'Initials': 'MA', 'LastName': 'Parker', 'Affiliation': 'UVM Tobacco Center of Regulatory Science, University of Vermont, Burlington.'}, {'ForeName': 'Mollie E', 'Initials': 'ME', 'LastName': 'Miller', 'Affiliation': 'Center for Alcohol and Addiction Studies, Brown University, Providence, Rhode Island.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'DeSarno', 'Affiliation': 'UVM Tobacco Center of Regulatory Science, University of Vermont, Burlington.'}, {'ForeName': 'Jeff S', 'Initials': 'JS', 'LastName': 'Priest', 'Affiliation': 'UVM Tobacco Center of Regulatory Science, University of Vermont, Burlington.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Cioe', 'Affiliation': 'Center for Alcohol and Addiction Studies, Brown University, Providence, Rhode Island.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'MacLeod', 'Affiliation': 'UVM Tobacco Center of Regulatory Science, University of Vermont, Burlington.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Barrows', 'Affiliation': 'UVM Tobacco Center of Regulatory Science, University of Vermont, Burlington.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Markesich', 'Affiliation': 'UVM Tobacco Center of Regulatory Science, University of Vermont, Burlington.'}, {'ForeName': 'Roxanne F', 'Initials': 'RF', 'LastName': 'Harfmann', 'Affiliation': 'UVM Tobacco Center of Regulatory Science, University of Vermont, Burlington.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.19311']
1552,33079199,Factors Associated With US Adults' Likelihood of Accepting COVID-19 Vaccination.,"Importance


The development of a coronavirus disease 2019 (COVID-19) vaccine has progressed at unprecedented speed. Widespread public uptake of the vaccine is crucial to stem the pandemic.
Objective


To examine the factors associated with survey participants' self-reported likelihood of selecting and receiving a hypothetical COVID-19 vaccine.
Design, Setting, and Participants


A survey study of a nonprobability convenience sample of 2000 recruited participants including a choice-based conjoint analysis was conducted to estimate respondents' probability of choosing a vaccine and willingness to receive vaccination. Participants were asked to evaluate their willingness to receive each hypothetical vaccine individually. The survey presented respondents with 5 choice tasks. In each, participants evaluated 2 hypothetical COVID-19 vaccines and were asked whether they would choose vaccine A, vaccine B, or neither vaccine. Vaccine attributes included efficacy, protection duration, major adverse effects, minor adverse effects, US Food and Drug Administration (FDA) approval process, national origin of vaccine, and endorsement. Levels of each attribute for each vaccine were randomly assigned, and attribute order was randomized across participants. Survey data were collected on July 9, 2020.
Main Outcomes and Measures


Average marginal component effect sizes and marginal means were calculated to estimate the relationship between each vaccine attribute level and the probability of the respondent choosing a vaccine and self-reported willingness to receive vaccination.
Results


A total of 1971 US adults responded to the survey (median age, 43 [interquartile range, 30-58] years); 999 (51%) were women, 1432 (73%) White, 277 (14%) were Black, and 190 (10%) were Latinx. An increase in efficacy from 50% to 70% was associated with a higher probability of choosing a vaccine (coefficient, 0.07; 95% CI, 0.06-0.09), and an increase from 50% to 90% was associated with a higher probability of choosing a vaccine (coefficient, 0.16; 95% CI, 0.15-0.18). An increase in protection duration from 1 to 5 years was associated with a higher probability of choosing a vaccine (coefficient, 0.05 95% CI, 0.04-0.07). A decrease in the incidence of major adverse effects from 1 in 10 000 to 1 in 1 000 000 was associated with a higher probability of choosing a vaccine (coefficient, 0.07; 95% CI, 0.05-0.08). An FDA emergency use authorization was associated with a lower probability of choosing a vaccine (coefficient, -0.03; 95% CI, -0.04 to -0.01) compared with full FDA approval. A vaccine that originated from a non-US country was associated with a lower probability of choosing a vaccine (China: -0.13 [95% CI, -0.15 to -0.11]; UK: -0.04 [95% CI, -0.06 to -0.02]). Endorsements from the US Centers for Disease Control and Prevention (coefficient, 0.09; 95% CI, 0.07-0.11) and the World Health Organization (coefficient, 0.06; 95% CI, 0.04-0.08), compared with an endorsement from President Trump were associated with higher probabilities of choosing a vaccine. Analyses of participants' willingness to receive each vaccine when assessed individually yielded similar results. An increase in efficacy from 50% to 90% was associated with a 10% higher marginal mean willingness to receive a vaccine (from 0.51 to 0.61). A reduction in the incidence of major side effects was associated with a 4% higher marginal mean willingness to receive a vaccine (from 0.54 to 0.58). A vaccine originating in China was associated with a 10% lower willingness to receive a vaccine vs one developed in the US (from 0.60 to 0.50) Endorsements from the Centers for Disease Control and Prevention and World Health Organization were associated with increases in willingness to receive a vaccine (7% and 6%, respectively) from a baseline endorsement by President Trump (from 0.52 to 0.59 and from 0.52 to 0.58, respectively).
Conclusions and Relevance


In this survey study of US adults, vaccine-related attributes and political characteristics were associated with self-reported preferences for choosing a hypothetical COVID-19 vaccine and self-reported willingness to receive vaccination. These results may help inform public health campaigns to address vaccine hesitancy when a COVID-19 vaccine becomes available.",2020,A reduction in the incidence of major side effects was associated with a 4% higher marginal mean willingness to receive a vaccine (from 0.54 to 0.58).,"['White, 277 (14%) were Black, and 190 (10%) were Latinx', ""nonprobability convenience sample of 2000 recruited participants including a choice-based conjoint analysis was conducted to estimate respondents' probability of choosing a vaccine and willingness to receive vaccination"", '1971 US adults responded to the survey (median age, 43 [interquartile range, 30-58] years); 999 (51%) were women, 1432 (73']","['vaccine A, vaccine B, or neither vaccine']","['efficacy', 'incidence of major side effects', 'efficacy, protection duration, major adverse effects, minor adverse effects, US Food and Drug Administration (FDA) approval process, national origin of vaccine, and endorsement', 'incidence of major adverse effects', 'vaccine attribute level and the probability of the respondent choosing a vaccine and self-reported willingness to receive vaccination', 'World Health Organization', 'protection duration']","[{'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C4517622', 'cui_str': '190'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C5191069', 'cui_str': '999'}, {'cui': 'C4708917', 'cui_str': '1432'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0041714', 'cui_str': 'United States Food, Drug Administration'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0449234', 'cui_str': 'Attribute'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}]",2000.0,0.247281,A reduction in the incidence of major side effects was associated with a 4% higher marginal mean willingness to receive a vaccine (from 0.54 to 0.58).,"[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Kreps', 'Affiliation': 'Department of Government, Cornell University, Ithaca, New York.'}, {'ForeName': 'Sandip', 'Initials': 'S', 'LastName': 'Prasad', 'Affiliation': 'Atlantic Medical Group, Morristown Medical Center, Morris Township, New Jersey.'}, {'ForeName': 'John S', 'Initials': 'JS', 'LastName': 'Brownstein', 'Affiliation': 'Department of Pediatrics, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Yulin', 'Initials': 'Y', 'LastName': 'Hswen', 'Affiliation': ""Computational Epidemiology Lab, Boston Children's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Brian T', 'Initials': 'BT', 'LastName': 'Garibaldi', 'Affiliation': 'Johns Hopkins Biocontainment Unit, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Baobao', 'Initials': 'B', 'LastName': 'Zhang', 'Affiliation': 'Department of Government, Cornell University, Ithaca, New York.'}, {'ForeName': 'Douglas L', 'Initials': 'DL', 'LastName': 'Kriner', 'Affiliation': 'Department of Government, Cornell University, Ithaca, New York.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.25594']
1553,33079238,Evaluation of new motorized articulating laparoscopic instruments by laparoscopic novices using a standardized laparoscopic skills curriculum.,"BACKGROUND


Motorized articulating laparoscopic instruments (ALI) offer more degrees of freedom than conventional laparoscopic instruments (CLI). However, a difficult learning curve and complex instrument handling are still a problem of ALI. We compared the performance of new prototypes of motorized ALI with CLI in a series of standardized laparoscopic tasks performed by laparoscopic novices. Further, usability of the new ALI was assessed.
METHODS


A randomized cross-over study with 50 laparoscopic novices who either started with CLI and then changed to ALI (CA) or vice versa (AC) was conducted. All participants performed the European training in basic laparoscopic urological skills (E-BLUS) with each instrument in given order. Time and errors were measured for each exercise. Instrument usability was assessed.
RESULTS


Overall, using CLI was significantly faster (CLI 4:27 min vs. ALI 4:50 min; p-value 0.005) and associated with fewer exercise failures in needle guidance (CLI 0 vs. ALI 12; p-value 0.0005) than ALI. Median amount of errors was similar for both instruments. Instrument sequence did not matter, as CA and AC showed comparable completion times. Regarding the learning effect, participants were significantly faster in the second attempt of exercises than in the first. In the needle guidance task, participants using CLI last demonstrated a significant speed improvement, whereas ALI were significantly slower in the second run. Regarding usability, CLI were preferred over ALI due to lighter weight and easier handling. Nevertheless, participants valued ALI's additional degrees of freedom.
CONCLUSION


Using new motorized ALI in the E-BLUS examination by laparoscopic novices led to a worse performance compared to CLI. An explanation could be that participants felt overwhelmed by ALI and that ALI have an own distinct learning curve. As participants valued ALI's additional degrees of freedom, however, a future application of ALI could be for training purposes, ideally in combination with CLI.",2020,Using new motorized ALI in the E-BLUS examination by laparoscopic novices led to a worse performance compared to CLI.,['50 laparoscopic novices who either started with CLI and then changed to ALI (CA) or vice versa (AC) was conducted'],"['European training', 'motorized ALI with CLI', 'conventional laparoscopic instruments (CLI']","['Time and errors', 'exercise failures', 'ALI', 'Median amount of errors']","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0242488', 'cui_str': 'Acute lung injury'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",50.0,0.0292614,Using new motorized ALI in the E-BLUS examination by laparoscopic novices led to a worse performance compared to CLI.,"[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Uysal', 'Affiliation': 'Medical School, University of Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Gasch', 'Affiliation': 'Department of Urology, Heidelberg University Hospital, Im Neuenheimer Feld 420, 69120, Heidelberg, Germany. claudia.gasch@med.uni-heidelberg.de.'}, {'ForeName': 'Rouven', 'Initials': 'R', 'LastName': 'Behnisch', 'Affiliation': 'Institute of Medical Biometry and Informatics (IMBI), University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Nickel', 'Affiliation': 'Department of General, Visceral, and Transplantation Surgery, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Beat Peter', 'Initials': 'BP', 'LastName': 'Müller-Stich', 'Affiliation': 'Department of General, Visceral, and Transplantation Surgery, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Hohenfellner', 'Affiliation': 'Department of Urology, Heidelberg University Hospital, Im Neuenheimer Feld 420, 69120, Heidelberg, Germany.'}, {'ForeName': 'Dogu', 'Initials': 'D', 'LastName': 'Teber', 'Affiliation': 'Department of Urology, Heidelberg University Hospital, Im Neuenheimer Feld 420, 69120, Heidelberg, Germany.'}]",Surgical endoscopy,['10.1007/s00464-020-08086-2']
1554,33079303,Novel Technique for Single-Layer Pancreatojejunostomy is Not Inferior to Modified Blumgart Anastomosis in Robotic Pancreatoduodenectomy: Results of a Randomized Controlled Trial.,"BACKGROUND


A novel technique of single-layer continuous suturing (SCS) for pancreaticojejunostomy (PJ) during robotic pancreaticoduodenectomy (RPD), a technically straightforward procedure, has been shown to produce promising results in a previous study. The present RCT aims to show that SCS during RPD does not increase the incidence of clinically relevant postoperative pancreatic fistula (CR-POPF) when compared with modified Blumgart anastomosis (MBA).
PATIENTS AND METHODS


Between January 2019 and September 2019, consecutive patients (ASA score ≤ 2) who underwent RPD were enrolled and randomized to the SCS or the MBA group. The primary endpoint was the rate of CR-POPF. A noninferiority margin of 10% was chosen.
RESULTS


Of the 186 patients, 4 were excluded because PJ was not performed. The remaining 182 patients were randomized to the SCS group (n = 89) or MBA group (n = 93). CR-POPF rate was not inferior in the SCS group [SCS: 6.7%, MBA: 11.8%; 95% confidence interval (- 0.76, - 0.06), P = 0.0002]. PJ duration was significantly lower in the SCS group (P < 0.01). No significant differences were found between the two groups in operative time, estimated blood loss, postoperative hospital stay, or rates of conversion to laparotomy, morbidity, reoperation, or mortality. On subgroup analysis of patients with a soft pancreas and small main pancreatic duct, SCS significantly reduced the duration of PJ.
CONCLUSIONS


This study showed that SCS was not inferior to MBA in terms of the CR-POPF rate during RPD. Registration number: ChiCTR1800020086 ( www.Chictr.org.cn ).",2020,"No significant differences were found between the two groups in operative time, estimated blood loss, postoperative hospital stay, or rates of conversion to laparotomy, morbidity, reoperation, or mortality.","['186 patients', 'Robotic Pancreatoduodenectomy', '182 patients', 'Between January 2019 and September 2019, consecutive patients (ASA score\u2009≤\u20092) who underwent RPD were enrolled and randomized to the SCS or the MBA group']","['single-layer continuous suturing (SCS) for pancreaticojejunostomy (PJ) during robotic pancreaticoduodenectomy (RPD', 'SCS', 'MBA']","['CR-POPF rate', 'duration of PJ', 'operative time, estimated blood loss, postoperative hospital stay, or rates of conversion to laparotomy, morbidity, reoperation, or mortality', 'PJ duration', 'rate of CR-POPF']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0085162', 'cui_str': 'Pancreaticoduodenectomy'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0030303', 'cui_str': 'Pancreaticojejunostomy'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0085162', 'cui_str': 'Pancreaticoduodenectomy'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0030290', 'cui_str': 'Pancreatic fistula'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0030303', 'cui_str': 'Pancreaticojejunostomy'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C1443559', 'cui_str': 'Estimated blood loss'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0023038', 'cui_str': 'Laparotomy'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.153508,"No significant differences were found between the two groups in operative time, estimated blood loss, postoperative hospital stay, or rates of conversion to laparotomy, morbidity, reoperation, or mortality.","[{'ForeName': 'Qu', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': ""Faculty of Hepatopancreatobiliary Surgery, The First Medical Center of Chinese People's Liberation Army (PLA) General Hospital, Beijing, China.""}, {'ForeName': 'Zhiming', 'Initials': 'Z', 'LastName': 'Zhao', 'Affiliation': ""Faculty of Hepatopancreatobiliary Surgery, The First Medical Center of Chinese People's Liberation Army (PLA) General Hospital, Beijing, China.""}, {'ForeName': 'Yuanxing', 'Initials': 'Y', 'LastName': 'Gao', 'Affiliation': ""Faculty of Hepatopancreatobiliary Surgery, The First Medical Center of Chinese People's Liberation Army (PLA) General Hospital, Beijing, China.""}, {'ForeName': 'Guodong', 'Initials': 'G', 'LastName': 'Zhao', 'Affiliation': ""Faculty of Hepatopancreatobiliary Surgery, The First Medical Center of Chinese People's Liberation Army (PLA) General Hospital, Beijing, China.""}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Jiang', 'Affiliation': ""Faculty of Hepatopancreatobiliary Surgery, The First Medical Center of Chinese People's Liberation Army (PLA) General Hospital, Beijing, China.""}, {'ForeName': 'Wan Yee', 'Initials': 'WY', 'LastName': 'Lau', 'Affiliation': 'Faculty of Medicine, The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong, SAR, China.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Liu', 'Affiliation': ""Faculty of Hepatopancreatobiliary Surgery, The First Medical Center of Chinese People's Liberation Army (PLA) General Hospital, Beijing, China. Liurong301@126.com.""}]",Annals of surgical oncology,['10.1245/s10434-020-09204-z']
1555,33079329,Long-term follow-up 3 years after a randomized rehabilitation study among radiated prostate cancer survivors.,"PURPOSE


In the Rehabilitation of Prostate Cancer (RePCa) study, the intervention reduced early adverse effects in prostate cancer 6 months after radiotherapy. This 3-year follow-up study assesses late adverse effects, evaluates rehabilitative long-term effects and identifies patients who benefit the most.
DESIGN


RePCa was a randomized clinical trial with multidisciplinary rehabilitation (n = 79) or usual care (n = 82). The intervention during the first 6 months consisted of consultations by nurses and physiotherapists focusing on psychosocial support and physical activity, respectively. Here we report the 3-year follow-up. Data consisted of disease-specific quality of life (EPIC-26), general quality of life (SF-12) and pelvic floor strength measured by electromyography.
RESULTS


One hundred forty-three patients (92%) responded. The primary outcome urinary irritative sum-score was no longer significantly different between groups. In patients with moderate-severe urinary problems at baseline, we observed a significant long-term effect on the urinary irritative sum-score in favour of the intervention (+ 13.4 points P = .014). More patients had moderate-severe bowel problems in the control group (n = 10; 14%) compared to the intervention group (n = 2; 3%) (P = .016). Pelvic floor strength deteriorated significantly in both groups.
CONCLUSION


The short-term rehabilitation was beneficial but of limited benefit in the long term for all patients. A significant and clinically relevant effect was found in irradiated prostate cancer patients with moderate-severe urinary problems at baseline. In both groups, pelvic floor strength was weakened during follow-up.
IMPACT FOR CANCER SURVIVORS


Prior research showed patients benefit from early rehabilitation. Identification of patients with moderate-severe urinary problems followed by a focused rehabilitation during the first 6 months after radiotherapy results in long-term improvement. Radiated patients have to be aware of their pelvic floor strength.
IMPLICATIONS FOR CANCER SURVIVORS


Patients can be informed that they benefit from early rehabilitation, and they cannot expect larger changes in adverse effects within the first years, but they have to be aware of their pelvic floor strength. Future rehabilitation studies could be applied mainly to patients with assessed rehabilitation needs after radiotherapy and intensified with long-term follow-up.",2020,"Pelvic floor strength deteriorated significantly in both groups.
","['patients with moderate-severe urinary problems', 'irradiated prostate cancer patients with moderate-severe urinary problems at baseline', 'One hundred forty-three patients (92%) responded', 'radiated prostate cancer survivors']",['multidisciplinary rehabilitation (n\u2009=\u200979) or usual care'],"['disease-specific quality of life (EPIC-26), general quality of life (SF-12) and pelvic floor strength', 'urinary irritative sum-score', 'Pelvic floor strength deteriorated', 'pelvic floor strength', 'moderate-severe bowel problems']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0450368', 'cui_str': '43'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1273342', 'cui_str': 'Epithelial cell count'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0579086', 'cui_str': 'Bowel problem'}]",143.0,0.0687938,"Pelvic floor strength deteriorated significantly in both groups.
","[{'ForeName': 'Karin B', 'Initials': 'KB', 'LastName': 'Dieperink', 'Affiliation': 'Department of Oncology, Academy of Geriatric Cancer research, AgeCare, Odense University Hospital, Southern Boulevard 29, DK-5000, Odense, Denmark. Karin.dieperink@rsyd.dk.'}, {'ForeName': 'Steinbjørn', 'Initials': 'S', 'LastName': 'Hansen', 'Affiliation': 'Department of Oncology, Academy of Geriatric Cancer research, AgeCare, Odense University Hospital, Southern Boulevard 29, DK-5000, Odense, Denmark.'}, {'ForeName': 'Lis', 'Initials': 'L', 'LastName': 'Wagner', 'Affiliation': 'Farvergården, Farvergårdsvej 24, 3210, Vejby, Denmark.'}, {'ForeName': 'Lisbeth R', 'Initials': 'LR', 'LastName': 'Minet', 'Affiliation': 'Department of Clinical Research, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Olfred', 'Initials': 'O', 'LastName': 'Hansen', 'Affiliation': 'Department of Oncology, Academy of Geriatric Cancer research, AgeCare, Odense University Hospital, Southern Boulevard 29, DK-5000, Odense, Denmark.'}]",Journal of cancer survivorship : research and practice,['10.1007/s11764-020-00958-9']
1556,33079339,Enhancing Kangaroo Mother Care Uptake Through Implementation of an Education Protocol.,"OBJECTIVES


Kangaroo mother care (KMC) uptake is low despite KMC being an evidence based tool to decrease neonatal mortality. It is important that local strategies be developed to enhance KMC usage. This study aimed to assess the effect of implementing an education protocol on the usage of KMC in the NICU and at home after discharge.
METHODS


Preterm mother-infant dyads admitted to the NICU were enrolled prospectively. In initial 3 mo, baseline data on KMC usage in the unit and at home after discharge was collected. In the next three months, a KMC education protocol consisting of one-to-one counseling, education and sensitization of the mother and family members regarding benefits and procedure of KMC and focussed group discussions was implemented such that it became a unit work protocol. In the next 3 mo, data on KMC usage in the unit and at home after discharge was again collected and compared with the baseline data.
RESULTS


Implementation of the education protocol resulted in earlier initiation of KMC (2.49 ± 0.67 vs. 4.65 ± 0.99 d, p < 0.05); increased duration of KMC (8 h/d vs. 3 h/d, p < 0.05); a higher proportion of eligible preterms receiving KMC during hospital stay (100% vs. 75%, p < 0.05) and at home (87% vs. 28%, p < 0.05) and KMC being provided more often by other family members (27.1% vs. 5.7%, p < 0.05).
CONCLUSIONS


Implementation of a KMC education protocol resulted in improved KMC usage in the unit and at home 4 wk after discharge.",2020,"h/d, p < 0.05); a higher proportion of eligible preterms receiving KMC during hospital stay (100% vs. 75%, p < 0.05) and at home (87% vs. 28%, p < 0.05) and KMC being provided more often by other family members (27.1% vs. 5.7%, p < 0.05).
",['Preterm mother-infant dyads admitted to the NICU were enrolled prospectively'],[],"['earlier initiation of KMC', 'hospital stay', 'KMC usage', 'neonatal mortality', 'duration of KMC']","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}]",[],"[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C1257803', 'cui_str': 'Kangaroo-Mother Care'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0027616', 'cui_str': 'Neonatal Mortality'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]",,0.0408879,"h/d, p < 0.05); a higher proportion of eligible preterms receiving KMC during hospital stay (100% vs. 75%, p < 0.05) and at home (87% vs. 28%, p < 0.05) and KMC being provided more often by other family members (27.1% vs. 5.7%, p < 0.05).
","[{'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Kapoor', 'Affiliation': 'Department of Pediatrics, PGIMS, Rohtak, 124001, Haryana, India.'}, {'ForeName': 'Anjali', 'Initials': 'A', 'LastName': 'Verma', 'Affiliation': 'Department of Pediatrics, PGIMS, Rohtak, 124001, Haryana, India.'}, {'ForeName': 'Poonam', 'Initials': 'P', 'LastName': 'Dalal', 'Affiliation': 'Department of Pediatrics, PGIMS, Rohtak, 124001, Haryana, India.'}, {'ForeName': 'Geeta', 'Initials': 'G', 'LastName': 'Gathwala', 'Affiliation': 'Department of Pediatrics, PGIMS, Rohtak, 124001, Haryana, India. geetagathwala@gmail.com.'}, {'ForeName': 'Jagjit', 'Initials': 'J', 'LastName': 'Dalal', 'Affiliation': 'Department of Neonatology, PGIMS, Rohtak, Haryana, India.'}]",Indian journal of pediatrics,['10.1007/s12098-020-03537-z']
1557,33079379,Thromboprophylaxis for patients with newly diagnosed vs. recurrent cancers: a post-hoc analysis of the avert trial.,"Venous thromboembolic disease (VTE) is a common complication among patients with cancer. Data reporting risk of VTE among patients receiving chemotherapy for recurrent cancer compared to those with newly diagnosed tumors is scarce. Furthermore, it is unclear if thromboprophylaxis is beneficial and safe in these specific patient populations. Post-hoc analysis of the AVERT trial which was a randomized, placebo-controlled, double-blind trial comparing apixaban therapy to placebo for VTE prophylaxis among cancer patients who were intermediate-to-high risk for VTE and who were initiating chemotherapy. The HRs for recurrent VTE and major bleeding episodes in patients with newly diagnosed and recurrent cancers were calculated using a Cox regression model controlling for age, gender, and center. Of the 563 included patients 469 and 93 patients had newly diagnosed and recurrent cancers, respectively. Patients with recurrent cancer have a higher risk of VTE (Hazard ratio (HR): 1.53 (95% CI 1.0 to 2.33; p = 0.047) and major bleeding episodes (HR 2.89 (95% CI 1.52 to 5.49; p = 0.001) compared to those with newly diagnosed cancer. In patients with newly diagnosed cancers, the use of apixaban was associated with a significantly lower risk of VTE (HR 0.45; 95% CI 0.27-0.76; p = 0.002) and a higher rate of major bleeding (HR 2.10; 95% CI 1.09-4.08; p = 0.028). In patients with recurrent cancer, apixaban was associated with a significant lower rate of VTE (HR 0.26; 95% CI 0.13-0.53; p < 0.001) without an associated significantly increased risk of major bleeding (HR 1.82; 95% CI 0.36-9.15; p = 0.466). Patients with recurrent cancer seem to be at higher risk of recurrent VTE and major bleeding complications compared to those with newly diagnosed tumors. Apixaban appears to be safe and effective in these patient populations.",2020,Patients with recurrent cancer have a higher risk of VTE (Hazard ratio (HR): 1.53 (95% CI 1.0 to 2.33; p = 0.047) and major bleeding episodes (HR 2.89 (95% CI 1.52 to 5.49; p = 0.001) compared to those with newly diagnosed cancer.,"['patients receiving', 'patients with newly diagnosed and recurrent cancers', 'Patients with recurrent cancer', 'patients with newly diagnosed vs. recurrent cancers', '563 included patients 469 and 93 patients had newly diagnosed and recurrent cancers, respectively', 'cancer patients who were intermediate-to-high risk for VTE and who were initiating chemotherapy', 'patients with cancer']","['Apixaban', 'Thromboprophylaxis', 'placebo', 'apixaban therapy to placebo', 'chemotherapy']","['HRs for recurrent VTE and major bleeding episodes', 'major bleeding episodes', 'rate of major bleeding', 'rate of VTE', 'risk of major bleeding', 'recurrent VTE and major bleeding complications', 'risk of VTE']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0549379', 'cui_str': 'Recurrent cancer'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0630906', 'cui_str': 'vinyltriethoxysilane'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C1831808', 'cui_str': 'apixaban'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0630906', 'cui_str': 'vinyltriethoxysilane'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",563.0,0.283821,Patients with recurrent cancer have a higher risk of VTE (Hazard ratio (HR): 1.53 (95% CI 1.0 to 2.33; p = 0.047) and major bleeding episodes (HR 2.89 (95% CI 1.52 to 5.49; p = 0.001) compared to those with newly diagnosed cancer.,"[{'ForeName': 'James', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Institut du Savoir Montfort, Montfort Hospital, Ottawa, Canada.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Atalla', 'Affiliation': 'Department of Medicine, University of Ottawa, the Ottawa Hospital Research Institute, 501 Smyth Road, Box 201 a, Ottawa, ON, K1H 8L6, Canada.'}, {'ForeName': 'Ranjeeta', 'Initials': 'R', 'LastName': 'Mallick', 'Affiliation': 'Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'Philip S', 'Initials': 'PS', 'LastName': 'Wells', 'Affiliation': 'Department of Medicine, University of Ottawa, the Ottawa Hospital Research Institute, 501 Smyth Road, Box 201 a, Ottawa, ON, K1H 8L6, Canada.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Carrier', 'Affiliation': 'Department of Medicine, University of Ottawa, the Ottawa Hospital Research Institute, 501 Smyth Road, Box 201 a, Ottawa, ON, K1H 8L6, Canada. mcarrier@toh.ca.'}]",Journal of thrombosis and thrombolysis,['10.1007/s11239-020-02317-y']
1558,33079393,Health-related quality of life outcomes for the LEAP study-CALGB 70305 (Alliance): A lymphedema prevention intervention trial for newly diagnosed breast cancer patients.,"BACKGROUND


Lymphedema is an adverse effect of breast cancer treatment that causes swelling and pain in the arm and hand. We tested 2 lymphedema prevention interventions and their impact on health-related quality of life (HRQOL) in a group-randomized trial at 38 cooperative group sites within the United States.
METHODS


Patients were recruited before breast surgery. Sites were randomly assigned to education-only (EO) lymphedema prevention or education plus exercise and physical therapy (LEAP). Lymphedema was defined as a ≥10% difference in arm volume at any time from baseline to 18 months postsurgery. HRQOL was assessed using the Functional Assessment of Cancer Therapy-Breast plus 4 lymphedema items (FACT-B+4). Longitudinal mixed model regression analysis, adjusting for key demographic and clinical variables, examined participants' HRQOL by intervention group and lymphedema status.
RESULTS


A total of 547 patients (56% LEAP) were enrolled and completed HRQOL assessments. The results revealed no differences between the interventions in preventing lymphedema (P = .37) or HRQOL (FACT-B+4 total score; P = .8777). At 18 months, the presence of lymphedema was associated with HRQOL at borderline significance (P = .0825). However, African American patients reported greater lymphedema symptoms (P = .0002) and better emotional functioning (P = .0335) than patients of other races or ethnicities. Lower HRQOL during the intervention was associated with younger age (P ≤ .0001), Eastern Cooperative Oncology Group performance status >0 (P = .0002), ≥1 positive lymph nodes (P = .0009), having no education beyond high school (P < .0001), having undergone chemotherapy (P = .0242), and having had only axillary node dissection or sentinel node biopsy versus both (P = .0007).
CONCLUSION


The tested interventions did not differ in preventing lymphedema or in HRQOL outcomes. African American women reported greater HRQOL impacts due to lymphedema symptoms than women of other races or ethnicities.",2020,The results revealed no differences between the interventions in preventing lymphedema (P = .37) or HRQOL (FACT-B+4 total score; P = .8777).,"['38 cooperative group sites within the United States', '547 patients (56% LEAP) were enrolled and completed HRQOL assessments', 'African American women', 'newly diagnosed breast cancer patients', 'Patients were recruited before breast surgery']",['education-only (EO) lymphedema prevention or education plus exercise and physical therapy (LEAP'],"['axillary node dissection or sentinel node biopsy', 'presence of lymphedema', '≥1 positive lymph nodes', 'HRQOL', 'Lower HRQOL', 'lymphedema symptoms', 'Lymphedema', 'health-related quality of life (HRQOL', 'lymphedema', 'emotional functioning', 'lymphedema or in HRQOL outcomes']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0281588', 'cui_str': 'Assessment of quality of life'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0851312', 'cui_str': 'Breast surgery'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}]","[{'cui': 'C0193867', 'cui_str': 'Excision of axillary lymph nodes'}, {'cui': 'C0796693', 'cui_str': 'Sentinel lymph node biopsy'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",547.0,0.0909722,The results revealed no differences between the interventions in preventing lymphedema (P = .37) or HRQOL (FACT-B+4 total score; P = .8777).,"[{'ForeName': 'Michelle J', 'Initials': 'MJ', 'LastName': 'Naughton', 'Affiliation': 'Department of Internal Medicine, The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Heshan', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Drew K', 'Initials': 'DK', 'LastName': 'Seisler', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Le-Rademacher', 'Affiliation': 'Department of Health Sciences, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Jane M', 'Initials': 'JM', 'LastName': 'Armer', 'Affiliation': 'Department of Nursing Research, University of Missouri, Columbia, Missouri.'}, {'ForeName': 'Jill M', 'Initials': 'JM', 'LastName': 'Oliveri', 'Affiliation': 'Comprehensive Cancer Center, The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Sloan', 'Affiliation': 'Division of Oncology & Health Sciences Research, Mayo Clinic College of Medicine, Rochester, Minnesota.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Hock', 'Affiliation': 'Comprehensive Cancer Center, The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schwartz', 'Affiliation': 'Mount Sinai Medical Center, Miami Beach, Florida.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Unzeitig', 'Affiliation': 'City of Laredo, Laredo, Texas.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Melnik', 'Affiliation': 'Cancer Research Consortium of West Michigan, Grand Rapids, Michigan.'}, {'ForeName': 'Lisa D', 'Initials': 'LD', 'LastName': 'Yee', 'Affiliation': 'Division of Surgical Oncology, City of Hope, Duarte, California.'}, {'ForeName': 'Gini F', 'Initials': 'GF', 'LastName': 'Fleming', 'Affiliation': 'Department of Hematology/Oncology, University of Chicago, Chicago, Illinois.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Taylor', 'Affiliation': 'Alliance for Clinical Trials in Oncology Foundation, Protocol Operations Program Office, Chicago, Illinois.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Loprinzi', 'Affiliation': 'North Central Cancer Treatment Group, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Electra D', 'Initials': 'ED', 'LastName': 'Paskett', 'Affiliation': 'Department of Medicine, The Ohio State University, Columbus, Ohio.'}]",Cancer,['10.1002/cncr.33184']
1559,33079403,Chlorhexidine gluconate bathing in children with cancer or those undergoing hematopoietic stem cell transplantation: A double-blinded randomized controlled trial from the Children's Oncology Group.,"BACKGROUND


To the authors' knowledge, information regarding whether daily bathing with chlorhexidine gluconate (CHG) reduces central line-associated bloodstream infection (CLABSI) in pediatric oncology patients and those undergoing hematopoietic stem cell transplantation (HCT) is limited.
METHODS


In the current multicenter, randomized, double-blind, placebo-controlled trial, patients aged ≥2 months and <22 years with cancer or those undergoing allogeneic HCT were randomized 1:1 to once-daily bathing with 2% CHG-impregnated cloths or control cloths for 90 days. The primary outcome was CLABSI. Secondary endpoints included total positive blood cultures, acquisition of resistant organisms, and acquisition of cutaneous staphylococcal isolates with an elevated CHG mean inhibitory concentration.
RESULTS


The study was stopped early because of poor accrual. Among the 177 enrolled patients, 174 were considered as evaluable (88 were randomized to the CHG group and 86 were randomized to the control group). The rate of CLABSI per 1000 central line days in the CHG group was 5.44 versus 3.10 in the control group (risk difference, 2.37; 95% confidence interval, 0.05-4.69 [P = .049]). Post hoc conditional power analysis demonstrated a 0.2% chance that the results would have favored CHG had the study fully enrolled. The rate of total positive blood cultures did not differ between groups (risk difference, 2.37; 95% confidence interval, -0.41 to 5.14 [P = .078]). The number of patients demonstrating the new acquisition of resistant organisms did not differ between groups (P = .54). Patients in the CHG group were found to be more likely to acquire cutaneous staphylococcal isolates with an elevated CHG mean inhibitory concentration (P = .032).
CONCLUSIONS


The data from the current study do not support the use of routine CHG bathing in children with cancer or those undergoing allogeneic HCT.",2020,"The rate of total positive blood cultures did not differ between groups (risk difference, 2.37; 95% confidence interval, -0.41 to 5.14 [P = .078]).","['patients aged ≥2 months and <22 years with cancer or those undergoing allogeneic HCT', 'children with cancer or those undergoing allogeneic HCT', 'children with cancer or those undergoing hematopoietic stem cell transplantation', '177 enrolled patients, 174 were considered as evaluable (88 were randomized to the', 'pediatric oncology patients and those undergoing hematopoietic stem cell transplantation (HCT', ""Children's Oncology Group""]","['chlorhexidine gluconate (CHG', 'CHG', 'placebo', 'Chlorhexidine gluconate', 'daily bathing with 2% CHG-impregnated cloths or control cloths']","['rate of total positive blood cultures', 'total positive blood cultures, acquisition of resistant organisms, and acquisition of cutaneous staphylococcal isolates with an elevated CHG mean inhibitory concentration', 'new acquisition of resistant organisms', 'rate of CLABSI per 1000 central line days', 'elevated CHG mean inhibitory concentration']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4517604', 'cui_str': '174'}, {'cui': 'C1518931', 'cui_str': 'Pediatric oncology'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0055361', 'cui_str': 'Chlorhexidine gluconate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0039717', 'cui_str': 'Textiles'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0740299', 'cui_str': 'Blood culture positive for microorganism'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0029235', 'cui_str': 'Organism'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0055361', 'cui_str': 'Chlorhexidine gluconate'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C3161235', 'cui_str': 'CLABSI - central line associated bloodstream infection'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C1145640', 'cui_str': 'Central venous catheter'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",177.0,0.407035,"The rate of total positive blood cultures did not differ between groups (risk difference, 2.37; 95% confidence interval, -0.41 to 5.14 [P = .078]).","[{'ForeName': 'Danielle M', 'Initials': 'DM', 'LastName': 'Zerr', 'Affiliation': ""Seattle Children's Research Institute, Seattle, Washington.""}, {'ForeName': 'Aaron M', 'Initials': 'AM', 'LastName': 'Milstone', 'Affiliation': 'Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Christopher C', 'Initials': 'CC', 'LastName': 'Dvorak', 'Affiliation': 'Division of Pediatric Allergy, Immunology, and Blood and Marrow Transplantation, University of California at San Francisco, San Francisco, California.'}, {'ForeName': 'Amanda L', 'Initials': 'AL', 'LastName': 'Adler', 'Affiliation': ""Seattle Children's Research Institute, Seattle, Washington.""}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Division of Biostatistics, City of Hope, Duarte, California.'}, {'ForeName': 'Doojduen', 'Initials': 'D', 'LastName': 'Villaluna', 'Affiliation': ""Children's Oncology Group, Monrovia, California.""}, {'ForeName': 'Ha', 'Initials': 'H', 'LastName': 'Dang', 'Affiliation': 'Department of Preventive Medicine, University of Southern California, Los Angeles, California.'}, {'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'Qin', 'Affiliation': ""Seattle Children's Research Institute, Seattle, Washington.""}, {'ForeName': 'Amin', 'Initials': 'A', 'LastName': 'Addetia', 'Affiliation': ""Seattle Children's Research Institute, Seattle, Washington.""}, {'ForeName': 'Lolie C', 'Initials': 'LC', 'LastName': 'Yu', 'Affiliation': ""Department of Pediatrics, Children's Hospital, Louisiana State University Health New Orleans, New Orleans, Louisiana.""}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Conway Keller', 'Affiliation': ""Division of Hematology/Oncology, Connecticut Children's Medical Center, Hartford, Connecticut.""}, {'ForeName': 'Adam J', 'Initials': 'AJ', 'LastName': 'Esbenshade', 'Affiliation': ""Department of Pediatrics, the Monroe Carell Jr. Children's Hospital at Vanderbilt, Vanderbilt-Ingram Cancer Center, Vanderbilt University School of Medicine, Nashville, Tennessee.""}, {'ForeName': 'Keith J', 'Initials': 'KJ', 'LastName': 'August', 'Affiliation': ""Department of Pediatrics, Children's Mercy Hospital, Kansas City, Missouri.""}, {'ForeName': 'Brian T', 'Initials': 'BT', 'LastName': 'Fisher', 'Affiliation': ""Division of Pediatric Infectious Diseases, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.""}, {'ForeName': 'Lillian', 'Initials': 'L', 'LastName': 'Sung', 'Affiliation': 'Division of Haematology/Oncology, Program in Child Health Evaluative Sciences, The Hospital for Sick Children, Toronto, Ontario, Canada.'}]",Cancer,['10.1002/cncr.33271']
1560,33079411,A randomized study to prevent lymphedema in women treated for breast cancer: CALGB 70305 (Alliance).,"BACKGROUND


Lymphedema affects many women who are treated for breast cancer. We examined the effectiveness of an education-only (EO) versus education plus sleeve compression/exercise intervention (lymphedema education and prevention [LEAP]) on lymphedema incidence and range of motion (ROM) in a group-randomized trial across 38 cooperative group sites.
METHODS


The treating institution was randomly assigned to either EO or LEAP by a study statistician. All patients at a treating institution participated in the same intervention (EO or LEAP) to minimize contamination bias. Participants completed surveys, arm volume measurements, and self-reported ROM assessments before surgery and at 12 and 18 months after surgery. Lymphedema was defined as a ≥10% difference in limb volume at any time post-surgery up to 18 months after surgery or diagnosis by a health provider. Cochran-Mantel-Haenszel tests were used to compare lymphedema-free rates between groups, stratified by lymph node surgery type. Self-reported ROM differences were compared between groups.
RESULTS


A total of 554 participants (56% LEAP) were included in the analyses. At 18 months, lymphedema-free rates were 58% (EO) versus 55% (LEAP) (P = .37). ROM for both arms was greater in LEAP versus EO at 12 months; by 18 months, most women reported full ROM, regardless of group. In LEAP, only one-third wore a sleeve ≥75% of the time; 50% performed lymphedema exercises at least weekly.
CONCLUSION


Lymphedema incidence did not differ by intervention group at 18 months. Poor adherence in the LEAP group may have contributed. However, physical therapy may speed recovery of ROM. Further research is needed to effectively reduce the incidence and severity of lymphedema in patients who have breast cancer.",2020,Lymphedema was defined as a ≥10% difference in limb volume at any time post-surgery up to 18 months after surgery or diagnosis by a health provider.,"['All patients at a treating institution participated in the same intervention (EO or LEAP) to minimize contamination bias', '38 cooperative group sites', 'patients who have breast cancer', 'women treated for breast cancer: CALGB 70305 (Alliance', 'women who are treated for breast cancer', '554 participants (56% LEAP']","['education-only (EO) versus education plus sleeve compression/exercise intervention (lymphedema education and prevention [LEAP', 'EO or LEAP']","['lymphedema incidence and range of motion (ROM', 'lymphedema exercises', 'Lymphedema incidence', 'lymphedema-free rates', 'ROM', 'Lymphedema', 'limb volume', 'speed recovery of ROM']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0183336', 'cui_str': 'Sleeve'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}]","[{'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}]",554.0,0.0706027,Lymphedema was defined as a ≥10% difference in limb volume at any time post-surgery up to 18 months after surgery or diagnosis by a health provider.,"[{'ForeName': 'Electra D', 'Initials': 'ED', 'LastName': 'Paskett', 'Affiliation': 'The Ohio State University Comprehensive Cancer Center, Division of Cancer Prevention and Control, Department of Internal Medicine, College of Medicine, Columbus, Ohio.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Le-Rademacher', 'Affiliation': 'Department of Health Sciences Research, Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Jill M', 'Initials': 'JM', 'LastName': 'Oliveri', 'Affiliation': 'The Ohio State University Comprehensive Cancer Center, Population Sciences, Columbus, Ohio.'}, {'ForeName': 'Heshan', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of Health Sciences Research, Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Drew K', 'Initials': 'DK', 'LastName': 'Seisler', 'Affiliation': 'Department of Health Sciences Research, Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Sloan', 'Affiliation': 'Department of Health Sciences Research, Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Jane M', 'Initials': 'JM', 'LastName': 'Armer', 'Affiliation': 'University of Missouri Sinclair School of Nursing, Columbia, Missouri.'}, {'ForeName': 'Michelle J', 'Initials': 'MJ', 'LastName': 'Naughton', 'Affiliation': 'The Ohio State University Comprehensive Cancer Center, Division of Cancer Prevention and Control, Department of Internal Medicine, College of Medicine, Columbus, Ohio.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Hock', 'Affiliation': 'The Ohio State University Comprehensive Cancer Center, Stefanie Spielman Comprehensive Breast Center Oncology Rehabilitation, Columbus, Ohio.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schwartz', 'Affiliation': 'Department of Medicine, Division of Medical Oncology and Hematology, Mount Sinai Medical Center, Miami Beach, Florida.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Unzeitig', 'Affiliation': 'Doctors Hospital of Laredo, Laredo, Texas.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Melnik', 'Affiliation': 'Department of General Surgery, Division of Surgical Oncology and Breast Care Services, Spectrum Health, Grand Rapids, Michigan.'}, {'ForeName': 'Lisa D', 'Initials': 'LD', 'LastName': 'Yee', 'Affiliation': 'Division of Surgical Oncology, City of Hope, Duarte, California.'}, {'ForeName': 'Gini F', 'Initials': 'GF', 'LastName': 'Fleming', 'Affiliation': 'Department of Medicine, Section of Hematology/Oncology, University of Chicago Comprehensive Cancer Center, Chicago, Illinois.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Taylor', 'Affiliation': 'Biological Sciences Division, The University of Chicago, Alliance Protocol Operations Program Office, Chicago, Illinois.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Loprinzi', 'Affiliation': 'Department of Medical Oncology, Mayo Clinic, Rochester, Minnesota.'}]",Cancer,['10.1002/cncr.33183']
1561,33079474,"Effect of a nurse-led hypertension management program on quality of life, medication adherence and hypertension management in older adults: A randomized controlled trial.","AIM


This study evaluated the effects of a nurse-led hypertension management program on quality of life, medication adherence and hypertension management in older adults.
METHODS


A total of 74 hypertensive older adults residing in two different nursing homes were randomized to the intervention group (n = 37) or control group (n = 37). The intervention group participated in a training program consisting of 20 weeks of health education and motivational meetings. Data were collected using a hypertension management knowledge and behavior questionnaire, quality of life scale, Morisky Medication Adherence Scale, and measurements of blood pressure and anthropometric and biochemical parameters. Data were analyzed using the χ 2  -test, Wilcoxon signed-rank test and Mann-Whitney U-test.
RESULTS


Post-test systolic (118.64 ± 10.04 mmHg) and diastolic (77.83 ± 5.34 mmHg) blood pressures, and total cholesterol levels (178.43 ± 25.59 mg/dL) were significantly lower in the intervention group compared with the control group (130.54 ± 15.08 mmHg, 82.70 ± 7.69 mmHg, 200.7 ± 34.57 mg/dL, respectively). Post-test hypertension knowledge score (20.75 ± 1.01), medication adherence rate (100.0%), and quality of life scale physical component (58.42 ± 13.93) and mental component (64.24 ± 12.85) scores were significantly higher in the intervention group than in the control group (12.21 ± 2.48; 64.9%; 44.36 ± 16.73; 53.93 ± 15.71, respectively). In addition, mean post-test body mass index (27.19 ± 4.62 kg/m 2  ), weight (74.81 ± 15.33 kg), waist circumference (93.29 ± 15.20 cm), hip circumference (107.67 ± 14.05 cm) and total cholesterol (178.43 ± 25.59 mg/dL) values were lower than pretest (28.13 ± 4.96 kg/m 2  ; 77.37 ± 16.56 kg; 97.83 ± 16.23 cm; 112.89 ± 14.37 cm; 194.78 ± 38.64 mg/dL, respectively) in the intervention group.
CONCLUSIONS


The nurse-led hypertension management program implemented in this study provides an example of an effective program to guide nurses who work with older adults. Geriatr Gerontol Int 2020; ••: ••-••.",2020,"Post-test hypertension knowledge score (20.75 ± 1.01), medication adherence rate (100.0%), and quality of life scale physical component (58.42 ± 13.93) and mental component (64.24 ± 12.85) scores were significantly higher in the intervention group than in the control group (12.21 ± 2.48; 64.9%; 44.36 ± 16.73; 53.93 ± 15.71, respectively).","['older adults', '74 hypertensive older adults residing in two different nursing homes', 'nurses who work with older adults']","['nurse-led hypertension management program', 'training program consisting of 20\u2009weeks of health education and motivational meetings']","['total cholesterol', 'Post-test hypertension knowledge score', 'quality of life, medication adherence and hypertension management', 'waist circumference', 'medication adherence rate', 'hip circumference', 'blood pressures, and total cholesterol levels', 'quality of life scale physical component', 'hypertension management knowledge and behavior questionnaire, quality of life scale, Morisky Medication Adherence Scale, and measurements of blood pressure and anthropometric and biochemical parameters']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0043227', 'cui_str': 'Working'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0556656', 'cui_str': 'Meetings'}]","[{'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0562350', 'cui_str': 'Hip circumference'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0687753', 'cui_str': 'Knowledge Management'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",74.0,0.0372959,"Post-test hypertension knowledge score (20.75 ± 1.01), medication adherence rate (100.0%), and quality of life scale physical component (58.42 ± 13.93) and mental component (64.24 ± 12.85) scores were significantly higher in the intervention group than in the control group (12.21 ± 2.48; 64.9%; 44.36 ± 16.73; 53.93 ± 15.71, respectively).","[{'ForeName': 'Merve', 'Initials': 'M', 'LastName': 'Kolcu', 'Affiliation': 'Hamidiye Faculty of Nursing, Public Health Nursing Department, University of Health Sciences Turkey, Istanbul, Turkey.'}, {'ForeName': 'Ayse', 'Initials': 'A', 'LastName': 'Ergun', 'Affiliation': 'Faculty of Health Science, Division of Nursing, Public Health Nursing Department, Marmara University, Istanbul, Turkey.'}]",Geriatrics & gerontology international,['10.1111/ggi.14068']
1562,33074695,Children's evaluations of individually and structurally based inequalities: The role of status.,"Social inequalities limit important opportunities and resources for members of marginalized and disadvantaged groups. Understanding the origins of how children construct their understanding of social inequalities in the context of their everyday peer interactions has the potential to yield novel insights into when-and how-individuals respond to different types of social inequalities. The present study examined whether children ( N  = 176; 3- to 8-years-old; 52% female, 48% male; 70% European American, 16% African American, 10% Latinx, and 4% Asian American; middle-income backgrounds) differentiate between structurally based inequalities (e.g., based on gender) and individually based inequalities (e.g., based on merit). Children were randomly assigned to a group that received more (advantaged) or fewer (disadvantaged) resources than another group due to either their groups' meritorious performance on a task or the gender biases of the peer in charge of allocating resources. Overall, children evaluated structurally based inequalities to be more unfair and worthy of rectification than individually based inequalities, and disadvantaged children were more likely to view inequalities to be wrong and act to rectify them compared to advantaged children. With age, advantaged children became more likely to rectify the inequalities and judge perpetuating allocations to be unfair. Yet, the majority of children allocated equally in response to both types of inequality. The findings generated novel evidence regarding how children evaluate and respond to individually and structurally based inequalities, and how children's own status within the inequality informs these responses. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"With age, advantaged children became more likely to rectify the inequalities and judge perpetuating allocations to be unfair.","['members of marginalized and disadvantaged groups', 'children ( N  = 176; 3- to 8-years-old; 52% female, 48% male; 70% European American, 16% African American, 10% Latinx, and 4% Asian American; middle-income backgrounds) differentiate between structurally based inequalities (e.g., based on gender) and individually based inequalities (e.g., based on merit']","[""more (advantaged) or fewer (disadvantaged) resources than another group due to either their groups' meritorious performance on a task or the gender biases of the peer in charge of allocating resources""]",[],"[{'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0012613', 'cui_str': 'Disadvantaged'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0003988', 'cui_str': 'Asian Americans'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0205615', 'cui_str': 'Well differentiated'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0242503', 'cui_str': 'Unequal'}, {'cui': 'C0079399', 'cui_str': 'Gender'}]","[{'cui': 'C0205388', 'cui_str': 'Few'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0205906', 'cui_str': 'Gender Bias'}]",[],,0.0184298,"With age, advantaged children became more likely to rectify the inequalities and judge perpetuating allocations to be unfair.","[{'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Rizzo', 'Affiliation': 'New York University.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Killen', 'Affiliation': 'University of Maryland.'}]",Developmental psychology,['10.1037/dev0001118']
1563,33074709,Effect of Endoplasmic Reticulum Stress on Endothelial Ischemia-Reperfusion Injury in Humans.,"Endoplasmic reticulum stress contributes to ischemia-reperfusion (I/R) injury in rodent and cell models. However, the contribution of endoplasmic reticulum stress in the pathogenesis of endothelial I/R injury in humans is unknown. We tested the hypothesis that compared with placebo, inhibition of endoplasmic reticulum stress via ingestion of tauroursodeoxycholic acid would prevent the attenuation of endothelium-dependent vasodilation following I/R injury. Twelve young adults (six women) were studied following ingestion of a placebo or 1,500 mg tauroursodeoxycholic acid (TUDCA). Endothelium-dependent vasodilation was assessed via brachial artery flow-mediated dilation (duplex ultrasonography) before and after I/R injury, which was induced by 20 min of arm ischemia followed by 20 min of reperfusion. Endothelium-independent vasodilation (glyceryl trinitrate-mediated vasodilation) was also assessed after I/R injury. Compared with placebo, TUDCA ingestion increased circulating plasma concentrations by 145 ± 90 ng ml -1  and increased concentrations of the taurine unconjugated form, ursodeoxycholic acid by 560 ± 156 ng ml -1  (both P < 0.01). Ischemia-reperfusion injury attenuated endothelium-dependent vasodilation, an effect that did not differ between placebo (pre-I/R, 5.0 ± 2.1% vs. post-I/R 3.5 ± 2.2%) and TUDCA (pre-I/R, 5.6 ± 2.1% vs. post-I/R 3.9 ± 2.1%; P = 0.8) conditions. Similarly, endothelium-independent vasodilation did not differ between conditions (placebo, 19.6 ± 4.8% vs. TUDCA, 19.7 ± 6.1%; P = 0.9). Taken together, endoplasmic reticulum stress does not appear to contribute to endothelial I/R injury in healthy young adults.",2020,"Compared with placebo, TUDCA ingestion increased circulating plasma concentrations by 145 ± 90 ng ml -1  and increased concentrations of the taurine unconjugated form, ursodeoxycholic acid by 560 ± 156 ng ml -1  (both P < 0.01).","['healthy young adults', 'Twelve young adults (six women', 'Humans']","['tauroursodeoxycholic acid', 'placebo or 1,500 mg tauroursodeoxycholic acid (TUDCA', 'placebo', 'ursodeoxycholic acid', 'Endoplasmic Reticulum Stress', 'placebo, TUDCA ingestion']","['circulating plasma concentrations', 'Endothelial Ischemia-Reperfusion Injury', 'endothelium-independent vasodilation', 'Endothelium-dependent vasodilation was assessed via brachial artery flow-mediated dilation (duplex ultrasonography', 'Endothelium-independent vasodilation (glyceryl trinitrate-mediated vasodilation']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0075857', 'cui_str': 'tauroursodeoxycholic acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0042105', 'cui_str': 'ursodeoxycholic acid'}, {'cui': 'C3178870', 'cui_str': 'Stress, Endoplasmic Reticulum'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0035126', 'cui_str': 'Ischemia-reperfusion injury'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0042401', 'cui_str': 'Vasodilatation'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0442436', 'cui_str': 'Via brachial artery'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0444916', 'cui_str': 'Duplex'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0017887', 'cui_str': 'Nitroglycerin'}]",12.0,0.314787,"Compared with placebo, TUDCA ingestion increased circulating plasma concentrations by 145 ± 90 ng ml -1  and increased concentrations of the taurine unconjugated form, ursodeoxycholic acid by 560 ± 156 ng ml -1  (both P < 0.01).","[{'ForeName': 'Holden W', 'Initials': 'HW', 'LastName': 'Hemingway', 'Affiliation': 'Human Vascular Physiology Laboratory, Department of Physiology and Anatomy, University of North Texas Health Science Center, United States.'}, {'ForeName': 'Amy M', 'Initials': 'AM', 'LastName': 'Moore', 'Affiliation': 'Human Vascular Physiology Laboratory, Department of Physiology and Anatomy, University of North Texas Health Science Center, United States.'}, {'ForeName': 'Albert H', 'Initials': 'AH', 'LastName': 'Olivencia-Yurvati', 'Affiliation': 'Human Vascular Physiology Laboratory Department of Physiology and Anatomy; Department of Surgery, University of North Texas Health Science Center, United States.'}, {'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Romero', 'Affiliation': 'Human Vascular Physiology Laboratory, Department of Physiology and Anatomy, University of North Texas Health Science Center, United States.'}]","American journal of physiology. Regulatory, integrative and comparative physiology",['10.1152/ajpregu.00257.2020']
1564,33074729,Impact of Acutely Increased Endogenous- and Exogenous Ketone Bodies on FGF21 Levels in Humans.,"PURPOSE


Fibroblast growth factor (FGF) 21 is a circulating hormone with metabolic regulatory importance. In mice, FGF21 increases in response to a ketogenic diet and fasting. In humans, a similar increase is only observed after prolonged starvation. We aim to study the acute effects of ketone bodies on circulating FGF21 levels in humans.
METHODS


Participants from three randomized, placebo-controlled crossover studies, with increased endogenous or exogenous ketone bodies, were included. Study 1: patients with type 1 diabetes (T1D) (n = 9) were investigated after a) insulin deprivation and lipopolysaccharide (LPS) injection and b) insulin-controlled euglycemia. Study 2: patients with T1D (n = 9) were investigated after a) total insulin deprivation for 9 hours and b) insulin-controlled euglycemia. Study 3: Healthy adults (n = 9) were examined during a) 3-hydroxybutyrate (OHB) infusion and b) saline infusion. Plasma FGF21 was measured with immunoassay in serial samples.
RESULTS


Circulating OHB levels were significantly increased to 1.3, 1.5, and 5.5 mmol/l in the three studies, but no correlations with FGF21 levels were found. Also, no correlations between FGF21, insulin, or glucagon were found. Insulin deprivation and LPS injection resulted in increased plasma FGF21 levels at t = 120 min ( p  = .005) which normalized at t = 240 min.
CONCLUSION


We found no correlation between circulating FGF21 levels and levels of ketone bodies. This suggests that it is not ketosis  per se  which controls FGF21 production, but instead a rather more complex regulatory mechanism.
TRIAL REGISTRATION


clinicaltrials.gov ID number: Study 1: NCT02157155 (5/6-2014), study 2: NCT02077348 (4/3-2014), and study 3: NCT02357550 (6/2-2015).",2020,"Insulin deprivation and LPS injection resulted in increased plasma FGF21 levels at t = 120 min ( p  = .005) which normalized at t = 240 min.
","['humans', 'Participants from three randomized', 'Healthy adults (n\xa0=\xa09', 'Study 2: patients with T1D', 'Study 1: patients with type 1 diabetes (T1D) (n\xa0=\xa09', 'Humans']","['Insulin deprivation and LPS injection', 'insulin deprivation and lipopolysaccharide (LPS) injection and b) insulin-controlled euglycemia', 'Endogenous- and Exogenous Ketone Bodies', 'placebo', '3-hydroxybutyrate (OHB) infusion and b) saline infusion', 'ketone bodies', 'increased endogenous or exogenous ketone bodies']","['Plasma FGF21', 'FGF21 levels', 'plasma FGF21 levels', 'total insulin deprivation', 'circulating FGF21 levels and levels of ketone bodies', 'FGF21, insulin, or glucagon', 'circulating FGF21 levels', 'Circulating OHB levels']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0023810', 'cui_str': 'Lipopolysaccharide'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205227', 'cui_str': 'Endogenous'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0022631', 'cui_str': 'Ketone body'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0106006', 'cui_str': '3-hydroxybutyrate'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0972232', 'cui_str': 'fibroblast growth factor 21'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0022631', 'cui_str': 'Ketone body'}, {'cui': 'C0017687', 'cui_str': 'Glucagon'}, {'cui': 'C0036071', 'cui_str': 'salicylamide'}]",9.0,0.0303706,"Insulin deprivation and LPS injection resulted in increased plasma FGF21 levels at t = 120 min ( p  = .005) which normalized at t = 240 min.
","[{'ForeName': 'Esben Stistrup', 'Initials': 'ES', 'LastName': 'Lauritzen', 'Affiliation': 'Medical Research Laboratory, Aarhus University , Aarhus N, Denmark.'}, {'ForeName': 'Mads Vandsted', 'Initials': 'MV', 'LastName': 'Svart', 'Affiliation': 'Medical Research Laboratory, Aarhus University , Aarhus N, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Voss', 'Affiliation': 'Steno Diabetes Center Aarhus, Aarhus University Hospital , Aarhus N, Denmark.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Møller', 'Affiliation': 'Medical Research Laboratory, Aarhus University , Aarhus N, Denmark.'}, {'ForeName': 'Mette', 'Initials': 'M', 'LastName': 'Bjerre', 'Affiliation': 'Medical Research Laboratory, Aarhus University , Aarhus N, Denmark.'}]",Endocrine research,['10.1080/07435800.2020.1831015']
1565,33074755,"Letter by Siontis and Räber Regarding Article, ""Low-Attenuation Noncalcified Plaque on Coronary Computed Tomography Angiography Predicts Myocardial Infarction: Results From the Multicenter SCOT-HEART Trial (Scottish Computed Tomography of the HEART)"".",,2020,,['Myocardial Infarction'],[],[],"[{'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}]",[],[],,0.0247985,,"[{'ForeName': 'George C M', 'Initials': 'GCM', 'LastName': 'Siontis', 'Affiliation': 'Department of Cardiology, University Hospital Bern, Switzerland.'}, {'ForeName': 'Lorenz', 'Initials': 'L', 'LastName': 'Räber', 'Affiliation': 'Department of Cardiology, University Hospital Bern, Switzerland.'}]",Circulation,['10.1161/CIRCULATIONAHA.120.047472']
1566,33074756,"Letter by Alfonso et al Regarding Article, ""Low-Attenuation Noncalcified Plaque on Coronary Computed Tomography Angiography Predicts Myocardial Infarction: Results From the Multicenter SCOT-HEART Trial (Scottish Computed Tomography of the Heart)"".",,2020,,['Myocardial Infarction'],[],[],"[{'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}]",[],[],,0.0291932,,"[{'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Alfonso', 'Affiliation': 'Cardiology Department, Hospital Universitario de La Princesa, Universidad Autónoma de Madrid, IIS-IP, CIBER-CV, Madrid, Spain.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Cecconi', 'Affiliation': 'Cardiology Department, Hospital Universitario de La Princesa, Universidad Autónoma de Madrid, IIS-IP, CIBER-CV, Madrid, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Jiménez-Borreguero', 'Affiliation': 'Cardiology Department, Hospital Universitario de La Princesa, Universidad Autónoma de Madrid, IIS-IP, CIBER-CV, Madrid, Spain.'}]",Circulation,['10.1161/CIRCULATIONAHA.120.047361']
1567,33074760,"Response by Williams et al to Letter Regarding Article, ""Low-Attenuation Noncalcified Plaque on Coronary Computed Tomography Angiography Predicts Myocardial Infarction: Results From the Multicenter SCOT-HEART Trial (Scottish Computed Tomography of the HEART)"".",,2020,,['Myocardial Infarction'],[],[],"[{'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}]",[],[],,0.024603,,"[{'ForeName': 'Michelle C', 'Initials': 'MC', 'LastName': 'Williams', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science and Edinburgh Imaging, University of Edinburgh, United Kingdom (M.C.W., D.E.N., M.R.D.).'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Newby', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science and Edinburgh Imaging, University of Edinburgh, United Kingdom (M.C.W., D.E.N., M.R.D.).'}, {'ForeName': 'Damini', 'Initials': 'D', 'LastName': 'Dey', 'Affiliation': 'Cedars-Sinai Medical Center, Los Angeles, CA (D.D.).'}, {'ForeName': 'Marc R', 'Initials': 'MR', 'LastName': 'Dweck', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science and Edinburgh Imaging, University of Edinburgh, United Kingdom (M.C.W., D.E.N., M.R.D.).'}]",Circulation,['10.1161/CIRCULATIONAHA.120.049840']
1568,33074775,Primary Palliative Care for Patients with Advanced Hematologic Malignancies: A Pilot Trial of the SHARE Intervention.,"Objective:  Develop and pilot-test a nurse-led primary palliative care intervention for patients with advanced hematologic malignancies.  Background:  Nurse-led primary palliative care interventions may improve outpatient palliative care provision for patients with advanced hematologic malignancies.  Methods:  This two-phase, single-arm pilot study involved patients with recurrent or resistant hematologic malignancies, their caregivers, and oncology clinicians at two US-based urban, university-affiliated oncology clinics. Measurements included feasibility (enrollment rates, intervention fidelity, and outcome assessment rates) and acceptability (patient, caregiver, and clinician surveys).  Results:  In Phase 1 we developed and implemented an oncology nurse-led primary palliative care intervention for patients with recurrent or resistant hematologic malignancies and their caregivers. In Phase 2, we tested feasibility and acceptability. Twenty-six patient participants enrolled. Consent-to-approach rate was 78% and enrolled-to-consent rate was 84%. All enrolled participants received the intervention per protocol. Sixty-nine percent of patients and 100% of caregivers reported that the intervention helped them better understand the patient's illness and cope. Seventy-five percent of oncologists reported that the intervention improved their patients' quality of care, and 25% reported that it helped them take better care of patients.  Conclusions:  Although our pilot of oncology nurse-led primary palliative care for patients with advanced hematologic malignancies met some of its secondary feasibility endpoints, it did not meet its primary feasibility endpoint (enrollment) and acceptability was mixed. Protecting nursing staff time, increasing patient and clinician involvement in intervention development, and identifying patients with highest supportive needs may improve feasibility and acceptability of future primary palliative care in hematologic malignancy trials.",2020,Sixty-nine percent of patients and 100% of caregivers reported that the intervention helped them better understand the patient's illness and cope.,"['patients with recurrent or resistant hematologic malignancies and their caregivers', 'Twenty-six patient participants enrolled', 'patients with advanced hematologic malignancies', 'patients with recurrent or resistant hematologic malignancies, their caregivers, and oncology clinicians at two US-based urban, university-affiliated oncology clinics', 'Patients with Advanced Hematologic Malignancies']","['nurse-led primary palliative care intervention', 'oncology nurse-led primary palliative care intervention', 'Nurse-led primary palliative care interventions']","['feasibility and acceptability', 'feasibility (enrollment rates, intervention fidelity, and outcome assessment rates) and acceptability (patient, caregiver, and clinician surveys']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0376545', 'cui_str': 'Hematologic neoplasm'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C3839015', 'cui_str': 'Oncology clinic'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0557529', 'cui_str': 'Oncology nurse'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0085565', 'cui_str': 'Outcome Assessment (Health Care)'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]",,0.0623062,Sixty-nine percent of patients and 100% of caregivers reported that the intervention helped them better understand the patient's illness and cope.,"[{'ForeName': 'Judith M', 'Initials': 'JM', 'LastName': 'Resick', 'Affiliation': 'Section of Palliative Care and Medical Ethics, Division of General Internal Medicine, Palliative Research Center (PaRC), University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Sefcik', 'Affiliation': 'Section of Palliative Care and Medical Ethics, Division of General Internal Medicine, Palliative Research Center (PaRC), University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Arnold', 'Affiliation': 'Section of Palliative Care and Medical Ethics, Division of General Internal Medicine, Palliative Research Center (PaRC), University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Thomas W', 'Initials': 'TW', 'LastName': 'LeBlanc', 'Affiliation': 'Division of Hematologic Malignancies and Cellular Therapy, Duke University School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Bakitas', 'Affiliation': 'School of Nursing/Department of Medicine, The University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Margaret Quinn', 'Initials': 'MQ', 'LastName': 'Rosenzweig', 'Affiliation': 'School of Nursing, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Smith', 'Affiliation': 'Johns Hopkins Medical Institutions and Sidney Kimmel Comprehensive Cancer Center, Harry J. Duffey Family Professor of Palliative Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Kathleen A', 'Initials': 'KA', 'LastName': 'Dorritie', 'Affiliation': 'Division of Hematology-Oncology and Cancer Therapeutics Program, Department of Medicine, UPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Sehgal', 'Affiliation': 'Division of Hematology-Oncology and Cancer Therapeutics Program, Department of Medicine, UPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Im', 'Affiliation': 'Division of Hematology-Oncology and Cancer Therapeutics Program, Department of Medicine, UPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Rose', 'Initials': 'R', 'LastName': 'Folino', 'Affiliation': 'Division of Hematology-Oncology and Cancer Therapeutics Program, Department of Medicine, UPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Tarr', 'Affiliation': 'Primary Health Network, Sharon, Pennsylvania,, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Bress', 'Affiliation': 'Section of Palliative Care and Medical Ethics, Division of General Internal Medicine, Palliative Research Center (PaRC), University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Yael', 'Initials': 'Y', 'LastName': 'Schenker', 'Affiliation': 'Section of Palliative Care and Medical Ethics, Division of General Internal Medicine, Palliative Research Center (PaRC), University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}]",Journal of palliative medicine,['10.1089/jpm.2020.0407']
1569,32687081,The role of entropy monitoring in reducing propofol requirements during open heart surgeries. A prospective randomized study.,"Background


Hypotension, which is commonly associated with propofol induction of general anesthesia in coronary artery bypass grafting (CABG) surgery, may cause adverse consequences in patients with coronary artery diseases undergoing this type of surgeries. The clinical absence of verbal response and eyelash reflex was used as an endpoint for hypnosis. Spectral entropy, as a novel monitoring method for the endpoint of hypnosis, affect the dose of required anesthetic agents for induction as well as the hemodynamic profile during general anesthesia in CABG surgery.
Aims


We hypothesized that entropy monitoring might reduce the dose of propofol required for induction of anesthesia during CABG surgery and could maintain hemodynamic stability when compared with the conventional clinical monitoring.
Materials and Methods


Sixty adult patients of both sexes, aged 30-60 years, ASA II and III, and scheduled for CABG surgery were enrolled in this prospective, controlled, randomized, double-blind study. These patients were randomly divided into two equal groups to receive intravenous propofol for induction of anesthesia guided by either the patients' clinical response (Group I) or by entropy monitoring (Group II). The total dose of propofol used for induction of anesthesia was recorded. Hemodynamic parameters and entropy values were also recorded.
Results


Propofol consumption was significantly reduced in Group II than Group I (P = 0.000*). Heart rate showed no statistical significance between the two groups, whereas the mean arterial pressure significantly decreased at induction in group I compared to Group II (P = 0.000*). The entropy values were significantly lower in Group I than Group II at induction (P = 0.036* for state entropy; 0.002* for response entropy). However, during intubation, and after 1 and 5 min, entropy indices displayed a significant increase in Group I than Group II.
Conclusions


Entropy monitoring significantly reduced the dose of propofol required for induction of anesthesia and maintained hemodynamic stability compared to the conventional clinical monitoring during CABG surgeries.",2020,The entropy values were significantly lower in Group I than Group II at induction (P = 0.036,"['Sixty adult patients of both sexes, aged 30-60 years, ASA II and III, and scheduled for CABG surgery', 'open heart surgeries', 'patients with coronary artery diseases undergoing this type of surgeries']","['coronary artery bypass grafting (CABG) surgery', ""intravenous propofol for induction of anesthesia guided by either the patients' clinical response (Group I) or by entropy monitoring"", 'propofol', 'entropy monitoring']","['Propofol consumption', 'entropy values', 'propofol requirements', 'Heart rate', 'mean arterial pressure', 'verbal response and eyelash reflex', 'Hemodynamic parameters and entropy values']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0189745', 'cui_str': 'Open heart surgery'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}]","[{'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0853212', 'cui_str': 'Induction of anaesthesia'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0441843', 'cui_str': 'Group I'}, {'cui': 'C0376522', 'cui_str': 'Entropy'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0376522', 'cui_str': 'Entropy'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0422906', 'cui_str': 'Eyelash reflex'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",60.0,0.0314859,The entropy values were significantly lower in Group I than Group II at induction (P = 0.036,"[{'ForeName': 'Ahmed Said', 'Initials': 'AS', 'LastName': 'Elgebaly', 'Affiliation': 'Department of Anesthesia and PSICUD, Faculty of Medicine, Tanta University, Egypt.'}, {'ForeName': 'Mona B', 'Initials': 'MB', 'LastName': 'El Mourad', 'Affiliation': 'Department of Anesthesia and PSICUD, Faculty of Medicine, Tanta University, Egypt.'}, {'ForeName': 'Sameh Mohamad', 'Initials': 'SM', 'LastName': 'Fathy', 'Affiliation': 'Department of Anesthesia and PSICUD, Faculty of Medicine, Tanta University, Egypt.'}]",Annals of cardiac anaesthesia,['10.4103/aca.ACA_184_18']
1570,32687088,"Comparison of postoperative cognitive decline in patients undergoing conventional vs miniaturized cardiopulmonary bypass: A randomized, controlled trial.","Background


Neurocognitive dysfunction is a common complication of coronary artery bypass grafting (CABG) with incidence of 19-38%. The miniaturized cardiopulmonary bypass (MCPB) system was developed to reduce hemodilution and inflammation and provides better cerebral protection than conventional cardiopulmonary bypass (CCPB). In a meta-analysis, MCPB was associated with a 10-fold reduction in the incidence of strokes. However, its effect on postoperative cognitive decline (POCD) is unknown. We assessed if MCPB decreases POCD after CABG and compared the risk factors.
Methods


A total of 71 Asian patients presenting for elective CABG at a tertiary center were enrolled. They were randomly assigned to MCPB (n = 36) or CCPB group (n = 35) and followed up in a single-blinded, prospective, randomized controlled trial. The primary outcome was POCD as measured by the repeatable battery of neuropsychological status (RBANS). Inflammatory markers (tumor necrosis factor-alpha and interleukin-6), hematocrit levels, and neutron-specific enolase (NSE) levels were studied.
Results


Overall, the incidence of POCD at 3 months was 50%, and this was not significantly different between both groups (51.4 vs 50.0%, P = 0.90). Having <6 years of formal education [risk ratio (RR) = 3.014, 95% confidence interval (CI) = 1.054-8.618, P = 0.040] was significantly associated with POCD in the CCPB group, while the lowest hematocrit during cardiopulmonary bypass was independently associated with POCD in the MCPB group (RR = 0.931, 95% CI = 0.868-0.998, P = 0.044). The postoperative inflammatory markers and NSE levels were similar between the two groups.
Conclusions


This study shows that the MCPB was not superior to CCPB with cell salvage and biocompatible tubing with regard to the neurocognitive outcomes measured by the RBANS.",2020,This study shows that the MCPB was not superior to CCPB with cell salvage and biocompatible tubing with regard to the neurocognitive outcomes measured by the RBANS.,"['patients undergoing', '71 Asian patients presenting for elective CABG at a tertiary center were enrolled']","['conventional cardiopulmonary bypass (CCPB', 'MCPB', 'coronary artery bypass grafting (CABG', 'conventional vs miniaturized cardiopulmonary bypass', 'miniaturized cardiopulmonary bypass (MCPB) system', 'CCPB']","['POCD', 'postoperative cognitive decline (POCD', 'Inflammatory markers (tumor necrosis factor-alpha and interleukin-6), hematocrit levels, and neutron-specific enolase (NSE) levels', 'postoperative inflammatory markers and NSE levels', 'POCD as measured by the repeatable battery of neuropsychological status (RBANS', 'incidence of POCD']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0234985', 'cui_str': 'Mental Deterioration'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0518014', 'cui_str': 'Hematocrit - finding'}, {'cui': 'C0027946', 'cui_str': 'Neutron'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0031691', 'cui_str': 'Enolase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",71.0,0.232063,This study shows that the MCPB was not superior to CCPB with cell salvage and biocompatible tubing with regard to the neurocognitive outcomes measured by the RBANS.,"[{'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Yuhe', 'Affiliation': 'Department of Anesthesiology, Singapore General Hospital, 20 College Road, Academia, Level 5, Singapore.'}, {'ForeName': 'Sophia Tsong', 'Initials': 'ST', 'LastName': 'Huey Chew', 'Affiliation': 'Department of Anesthesiology, Singapore General Hospital, 20 College Road, Academia, Level 5; Department of Cardiovascular and Metabolic Disorders, Duke-National University of Singapore Graduate Medical School, 8 College Road, Singapore.'}, {'ForeName': 'An Shing', 'Initials': 'AS', 'LastName': 'Ang', 'Affiliation': 'Yong Loo Lin School of Medicine, National University of Singapore, 1E Kent Ridge Road, NUHS Tower Block, Level 11,, Singapore.'}, {'ForeName': 'Roderica Rui', 'Initials': 'RR', 'LastName': 'Ge Ng', 'Affiliation': 'Department of Anesthesiology, Singapore General Hospital, 20 College Road, Academia, Level 5; Department of Cardiac, Thoracic and Vascular Surgery, National University Hospital Singapore, 5 Lower Kent Ridge Road, Singapore.'}, {'ForeName': 'Nantawan', 'Initials': 'N', 'LastName': 'Boonkiangwong', 'Affiliation': 'Department of Cardiac, Thoracic and Vascular Surgery, National University Hospital Singapore, Singapore.'}, {'ForeName': 'Weiling', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'Yong Loo Lin School of Medicine, National University of Singapore, 1E Kent Ridge Road, NUHS Tower Block, Level 11; Department of Anesthesia, National University Health System, 5 Lower Kent Ridge Road, Singapore.'}, {'ForeName': 'Anastasia Han', 'Initials': 'AH', 'LastName': 'Hao Toh', 'Affiliation': 'Department of Psychological Medicine, National University Health System, 5 Lower Kent Ridge Road, Singapore.'}, {'ForeName': 'Michael George', 'Initials': 'MG', 'LastName': 'Caleb', 'Affiliation': 'Department of Anesthesiology, Singapore General Hospital, 20 College Road, Academia, Level 5; Department of Cardiac, Thoracic and Vascular Surgery, National University Hospital Singapore, 5 Lower Kent Ridge Road, Singapore.'}, {'ForeName': 'Roger Chun', 'Initials': 'RC', 'LastName': 'Man Ho', 'Affiliation': 'Yong Loo Lin School of Medicine, National University of Singapore, 1E Kent Ridge Road, NUHS Tower Block, Level 11; Department of Psychological Medicine, National University Health System, 5 Lower Kent Ridge Road, Singapore.'}, {'ForeName': 'Lian Kah', 'Initials': 'LK', 'LastName': 'Ti', 'Affiliation': 'Yong Loo Lin School of Medicine, National University of Singapore, 1E Kent Ridge Road, NUHS Tower Block, Level 11; Department of Anesthesia, National University Health System, 5 Lower Kent Ridge Road, Singapore.'}]",Annals of cardiac anaesthesia,['10.4103/aca.ACA_192_18']
1571,32687091,Pharmacological preconditioning with intralipid in patients undergoing off-pump coronary artery bypass surgery.,"Aims and Objectives


The objective of the study was to determine the preconditioning myocardial protective effects of intralipid (IL) in off-pump coronary artery bypass (OPCAB) surgery by measuring highly sensitive troponin T (hsTnT) and cardiac-specific creatine kinase (CK-MB) as markers of myocardial injury.
Materials and Methods


: Thirty patients, scheduled to undergo elective OPCAB surgery, were randomly assigned to the IL group (n = 15) or control (C) group (n = 15); the IL group received an infusion of 20% IL 2 ml/kg, 30 min prior to revascularization and the control group received an equivalent volume of normal saline. Serum levels of hsTnT and CK-MB were measured before surgery and at 6 h, 24 h, 48 h, and 72 h postoperatively. Also, intraoperative hemodynamic parameters, inotrope use, ventilatory hours, ICU stay, postoperative left ventricular ejection fraction, postoperative lipid profile, renal and hepatic function tests were measured.
Results


The hsTnT values at the 24 h, 48 h, and 72 h in IL group were significantly lower as compared with the control group. The decline in plasma levels of CK-MB mirrored the hsTnT levels post revascularization at 24 h and 48 h in the IL group compared with the control group; however, at 72 h, level was comparable in both the groups. None of the treated patients had abnormal lipid metabolism, deranged renal, and hepatic function.
Conclusion


The study revealed Intralipid as a safe pharmacological preconditioning agent for OPCAB surgeries which can reduce the postischemic myocardial injury indicated by the reduction in postischemic cardiac enzymes hsTnT and CK-MB.",2020,"The hsTnT values at the 24 h, 48 h, and 72 h in IL group were significantly lower as compared with the control group.","['patients undergoing off-pump coronary artery bypass surgery', 'Thirty patients, scheduled to undergo elective OPCAB surgery']","['pump coronary artery bypass (OPCAB) surgery', 'intralipid (IL', 'Materials and Methods\n\n\n', 'IL group received an infusion of 20% IL 2 ml/kg, 30 min prior to revascularization and the control group received an equivalent volume of normal saline', 'Pharmacological preconditioning with intralipid']","['Serum levels of hsTnT and CK-MB', 'intraoperative hemodynamic parameters, inotrope use, ventilatory hours, ICU stay, postoperative left ventricular ejection fraction, postoperative lipid profile, renal and hepatic function tests', 'plasma levels of CK-MB', 'abnormal lipid metabolism, deranged renal, and hepatic function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1449706', 'cui_str': 'Off-pump coronary artery bypass'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}]","[{'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C1449706', 'cui_str': 'Off-pump coronary artery bypass'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0733854', 'cui_str': 'Intralipid'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C1300574', 'cui_str': 'mL/kg'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439822', 'cui_str': 'Highly sensitive'}, {'cui': 'C0077404', 'cui_str': 'Troponin T'}, {'cui': 'C0010290', 'cui_str': 'Creatine kinase isoenzyme, MB fraction'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}]",,0.0830948,"The hsTnT values at the 24 h, 48 h, and 72 h in IL group were significantly lower as compared with the control group.","[{'ForeName': 'Gegal', 'Initials': 'G', 'LastName': 'Pruthi', 'Affiliation': 'Department of Cardiac Anaesthesiology, Sri Jayadeva Institute of Cardiovascular Sciences and Research, Jayanagar, Karnataka, India.'}, {'ForeName': 'Naveen G', 'Initials': 'NG', 'LastName': 'Singh', 'Affiliation': 'Department of Cardiac Anaesthesiology, Sri Jayadeva Institute of Cardiovascular Sciences and Research, Jayanagar, Karnataka, India.'}, {'ForeName': 'P S', 'Initials': 'PS', 'LastName': 'Nagaraja', 'Affiliation': 'Department of Cardiac Anaesthesiology, Sri Jayadeva Institute of Cardiovascular Sciences and Research, Jayanagar, Karnataka, India.'}, {'ForeName': 'Rohini Mayur', 'Initials': 'RM', 'LastName': 'Balaji', 'Affiliation': 'Department of Cardiac Anaesthesiology, Sri Jayadeva Institute of Cardiovascular Sciences and Research, Jayanagar, Karnataka, India.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Manjunatha', 'Affiliation': 'Department of Cardiac Anaesthesiology, Sri Jayadeva Institute of Cardiovascular Sciences and Research, Jayanagar, Karnataka, India.'}, {'ForeName': 'P K', 'Initials': 'PK', 'LastName': 'Choudhary', 'Affiliation': 'Department of Sports Medicine, Sports Authority of Karnataka, Bengaluru, Karnataka, India.'}, {'ForeName': 'M Kurinchi', 'Initials': 'MK', 'LastName': 'Raja', 'Affiliation': 'Department of Cardiac Anaesthesiology, Sri Jayadeva Institute of Cardiovascular Sciences and Research, Jayanagar, Karnataka, India.'}]",Annals of cardiac anaesthesia,['10.4103/aca.ACA_251_18']
1572,33066061,How does the Execution of the Pilates Method and Therapeutic Exercise Influence Back Pain and Postural Alignment in Children Who Play String Instruments? A Randomized Controlled Pilot Study.,"BACKGROUND


Inappropriate posture in children while playing some string instruments can cause back pain and alterations of the spine. To date, there is no research on the effect of exercise on children who play a musical instrument, although it is known that transversus abdominis muscle control through the Pilates method has shown pain reduction and posture improvement in this population.
OBJECTIVE


To assess the effectiveness of the Pilates method combined with therapeutic exercise with respect to therapeutic exercise exclusively in reducing pain and improving postural alignment in children playing string instruments applying a protocol of low dose to increase children's adherence to training.
METHODS


A randomized controlled pilot study was designed with two parallel intervention groups. Twenty-five children (10-14 years old) were randomized in two intervention groups: Pilates method with therapeutic exercise (experimental) and therapeutic exercise (control) for 4 weeks (50 min per day, one day per week). Two assessments were performed (before and after treatment) to assess back pain and shoulders and hips alignment using a visual analog scale and the Kinovea program.
RESULTS


Statistically significant differences were obtained for pain reduction before ( p  = 0.04) and after ( p  = 0.01) playing the instrument in the experimental group. There were no significant changes in alignment improvement in any of the two groups.
CONCLUSION


The application of a low dose of the Pilates method combined with therapeutic exercise could be a beneficial intervention for pain reduction before and after musical practice in children who play string instruments.",2020,Statistically significant differences were obtained for pain reduction before ( p  = 0.04) and after ( p  = 0.01) playing the instrument in the experimental group.,"['children playing string instruments', 'children who play string instruments', 'Children', 'Twenty-five children (10-14 years old']","['Pilates method with therapeutic exercise (experimental) and therapeutic exercise (control', 'Pilates method combined with therapeutic exercise']","['Back Pain and Postural Alignment', 'pain reduction', 'back pain and shoulders and hips alignment using a visual analog scale', 'pain and improving postural alignment']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0443313', 'cui_str': 'Stringing'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",25.0,0.0647546,Statistically significant differences were obtained for pain reduction before ( p  = 0.04) and after ( p  = 0.01) playing the instrument in the experimental group.,"[{'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Poncela-Skupien', 'Affiliation': 'Integral Rehabilitation Center, CRI. 38001, Santa Cruz de Tenerife, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Pinero-Pinto', 'Affiliation': 'Department of Physical Therapy, Faculty of Nursery, Physiotherapy and Podiatry, University of Seville, 41004 Seville, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Martínez-Cepa', 'Affiliation': 'Department of Physiotherapy, Faculty of Medicine, CEU-San Pablo University, 28003 Madrid, Spain.'}, {'ForeName': 'Juan Carlos', 'Initials': 'JC', 'LastName': 'Zuil-Escobar', 'Affiliation': 'Department of Physiotherapy, Faculty of Medicine, CEU-San Pablo University, 28003 Madrid, Spain.'}, {'ForeName': 'Rita Pilar', 'Initials': 'RP', 'LastName': 'Romero-Galisteo', 'Affiliation': 'Department of Physiotherapy, Faculty of Science Health, University of Málaga, 29016 Málaga, Spain.'}, {'ForeName': 'Rocío', 'Initials': 'R', 'LastName': 'Palomo-Carrión', 'Affiliation': 'Department of Nursery, Physiotherapy and Occupational Therapy, Faculty of Physiotherapy and Nursery, University of Castilla-La Mancha, 45071 Toledo, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17207436']
1573,33066081,Leukocyte Activation and Antioxidative Defense Are Interrelated and Moderately Modified by n-3 Polyunsaturated Fatty Acid-Enriched Eggs Consumption-Double-Blind Controlled Randomized Clinical Study.,"This placebo-controlled, double-blind, randomized, interventional study investigated the effects of low/intermediate doses of n-3 polyunsaturated fatty acids (PUFAs) on the endothelial function, markers of leukocyte activation, and oxidative status following dietary intake of n-3 PUFA-enriched hen eggs in young healthy individuals. Twenty young healthy adults of both sexes who consumed n-3 PUFA-enriched hen eggs (two eggs per day, for three weeks, total of approximately 407 mg/day n-3 PUFAs) or regular eggs (two eggs per day for three weeks, total of approximately 75 mg/day n-3 PUFAs) participated in this study. Skin microvascular endothelium-independent and endothelium-dependent vasodilation were assessed by laser Doppler flowmetry. Serum lipid profile and content of free fatty acids, markers of leukocyte activation, biochemical parameters of oxidative stress, as well as antioxidative enzymes serum activity were measured before and after respective dietary protocol. The results of this study revealed significant differences in the markers of leukocyte activation (such as CD11a/LFA-1) and antioxidative defense, which are related to increased intake of n-3 PUFAs, providing the evidence that consumption of nutritionally enriched hen eggs may affect physiological processes related to oxidative balance. The absence of significant changes in microvascular reactivity following supplementation with a low-intermediate dose of n-3 PUFAs, unlike in our previous studies where functional eggs contained ~1 g of n-3 PUFA, suggests the existence of a dose-dependent effect.",2020,"Serum lipid profile and content of free fatty acids, markers of leukocyte activation, biochemical parameters of oxidative stress, as well as antioxidative enzymes serum activity were measured before and after respective dietary protocol.","['young healthy individuals', 'Twenty young healthy adults of both sexes who consumed n-3 PUFA-enriched hen eggs (two eggs per day, for three weeks, total of approximately 407 mg/day n-3 PUFAs) or regular eggs (two eggs per day for three weeks, total of approximately 75 mg/day n-3 PUFAs) participated in this study']","['n-3 PUFA-enriched hen eggs', 'n-3 polyunsaturated fatty acids (PUFAs', 'placebo']","['endothelial function, markers of leukocyte activation, and oxidative status', 'Skin microvascular endothelium-independent and endothelium-dependent vasodilation', 'Serum lipid profile and content of free fatty acids, markers of leukocyte activation, biochemical parameters of oxidative stress, as well as antioxidative enzymes serum activity', 'microvascular reactivity']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0440466', 'cui_str': ""Hen's egg""}, {'cui': 'C0013710', 'cui_str': 'Eggs (edible)'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C4082109', 'cui_str': 'Three weeks'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0440466', 'cui_str': ""Hen's egg""}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0042401', 'cui_str': 'Vasodilatation'}, {'cui': 'C0428462', 'cui_str': 'Measurement of serum lipid level'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0015688', 'cui_str': 'Unesterified fatty acid'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0014442', 'cui_str': 'Enzyme'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}]",20.0,0.195935,"Serum lipid profile and content of free fatty acids, markers of leukocyte activation, biochemical parameters of oxidative stress, as well as antioxidative enzymes serum activity were measured before and after respective dietary protocol.","[{'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Mihalj', 'Affiliation': 'Department of Physiology and Immunology, Faculty of Medicine, Josip Juraj Strossmayer University of Osijek, J. Huttlera 4, HR-31000 Osijek, Croatia.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Stupin', 'Affiliation': 'Department of Physiology and Immunology, Faculty of Medicine, Josip Juraj Strossmayer University of Osijek, J. Huttlera 4, HR-31000 Osijek, Croatia.'}, {'ForeName': 'Nikolina', 'Initials': 'N', 'LastName': 'Kolobarić', 'Affiliation': 'Department of Physiology and Immunology, Faculty of Medicine, Josip Juraj Strossmayer University of Osijek, J. Huttlera 4, HR-31000 Osijek, Croatia.'}, {'ForeName': 'Ivana Tartaro', 'Initials': 'IT', 'LastName': 'Bujak', 'Affiliation': 'Radiation Chemistry and Dosimetry Laboratory, Division of Materials Chemistry, IRB, 10000 Zagreb, Croatia.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Matić', 'Affiliation': 'Department of Physiology and Immunology, Faculty of Medicine, Josip Juraj Strossmayer University of Osijek, J. Huttlera 4, HR-31000 Osijek, Croatia.'}, {'ForeName': 'Zlata', 'Initials': 'Z', 'LastName': 'Kralik', 'Affiliation': 'Department of Animal Production and Biotechnology, Faculty of Agrobiotechnical Sciences, Vladimira Preloga 1, HR-31000 Osijek, Croatia.'}, {'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Jukić', 'Affiliation': 'Department of Physiology and Immunology, Faculty of Medicine, Josip Juraj Strossmayer University of Osijek, J. Huttlera 4, HR-31000 Osijek, Croatia.'}, {'ForeName': 'Marko', 'Initials': 'M', 'LastName': 'Stupin', 'Affiliation': 'Department of Physiology and Immunology, Faculty of Medicine, Josip Juraj Strossmayer University of Osijek, J. Huttlera 4, HR-31000 Osijek, Croatia.'}, {'ForeName': 'Ines', 'Initials': 'I', 'LastName': 'Drenjančević', 'Affiliation': 'Department of Physiology and Immunology, Faculty of Medicine, Josip Juraj Strossmayer University of Osijek, J. Huttlera 4, HR-31000 Osijek, Croatia.'}]",Nutrients,['10.3390/nu12103122']
1574,33066103,Transcutaneous Spinal Cord Stimulation Enhances Quadriceps Motor Evoked Potential in Healthy Participants: A Double-Blind Randomized Controlled Study.,"Transcutaneous electrical spinal cord stimulation (tSCS) is a non-invasive technique for neuromodulation and has therapeutic potential for motor rehabilitation following spinal cord injury. The main aim of the present study is to quantify the effect of a single session of tSCS on lower limb motor evoked potentials (MEPs) in healthy participants. A double-blind, sham-controlled, randomized, crossover, clinical trial was carried out in 15 participants. Two 10-min sessions of tSCS (active-tSCS and sham-tSCS) were applied at the T11-T12 vertebral level. Quadriceps (Q) and tibialis anterior (TA) muscle MEPs were recorded at baseline, during and after tSCS. Q and TA isometric maximal voluntary contraction was also recorded. A significant increase of the Q-MEP amplitude was observed during active-tSCS (1.96 ± 0.3 mV) when compared from baseline (1.40 ± 0.2 mV;  p  = 0.01) and when compared to sham-tSCS at the same time-point (1.13 ± 0.3 mV;  p  = 0.03). No significant modulation was identified for TA-MEP amplitude or for Q and TA isometric maximal voluntary isometric strength. In conclusion, tSCS applied over the T11-T12 vertebral level increased Q-MEP but not TA-MEP compared to sham stimulation. The specific neuromodulatory effect of tSCS on Q-MEP may reflect optimal excitation of this motor response at the interneuronal or motoneuronal level.",2020,No significant modulation was identified for TA-MEP amplitude or for Q and TA isometric maximal voluntary isometric strength.,"['15 participants', 'healthy participants', 'Healthy Participants']","['tSCS', 'Transcutaneous Spinal Cord Stimulation', 'tSCS (active-tSCS and sham-tSCS', 'Transcutaneous electrical spinal cord stimulation (tSCS']","['TA-MEP amplitude or for Q and TA isometric maximal voluntary isometric strength', 'Q-MEP amplitude', 'lower limb motor evoked potentials (MEPs', 'T11-T12 vertebral level increased Q-MEP', 'Q and TA isometric maximal voluntary contraction', 'Quadriceps (Q) and tibialis anterior (TA) muscle MEPs']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0394477', 'cui_str': 'Neurostimulation of spinal cord tissue'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0054871', 'cui_str': 'Cathepsin L'}, {'cui': 'C0242690', 'cui_str': 'Tibialis anterior muscle structure'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0282617', 'cui_str': 'Motor Evoked Potentials'}, {'cui': 'C0054967', 'cui_str': 'Lymphocyte antigen CD6'}, {'cui': 'C0446409', 'cui_str': 'Vertebral level'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}]",15.0,0.247662,No significant modulation was identified for TA-MEP amplitude or for Q and TA isometric maximal voluntary isometric strength.,"[{'ForeName': 'Álvaro', 'Initials': 'Á', 'LastName': 'Megía-García', 'Affiliation': 'Biomechanical and Technical Aids Unit, National Hospital for Paraplegia, SESCAM, 45071 Toledo, Spain.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Serrano-Muñoz', 'Affiliation': 'Toledo Physiotherapy Research Group (GIFTO), Faculty of Physiotherapy and Nursing, Castilla La Mancha University, 45071 Toledo, Spain.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Taylor', 'Affiliation': 'Sensorimotor Function Group, National Hospital for Paraplegia, SESCAM, 45071 Toledo, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Avendaño-Coy', 'Affiliation': 'Toledo Physiotherapy Research Group (GIFTO), Faculty of Physiotherapy and Nursing, Castilla La Mancha University, 45071 Toledo, Spain.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Comino-Suárez', 'Affiliation': 'Toledo Physiotherapy Research Group (GIFTO), Faculty of Physiotherapy and Nursing, Castilla La Mancha University, 45071 Toledo, Spain.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Gómez-Soriano', 'Affiliation': 'Toledo Physiotherapy Research Group (GIFTO), Faculty of Physiotherapy and Nursing, Castilla La Mancha University, 45071 Toledo, Spain.'}]",Journal of clinical medicine,['10.3390/jcm9103275']
1575,33066107,Effects of  Bifidobacterium animalis  Subsp.  lactis  (BPL1) Supplementation in Children and Adolescents with Prader-Willi Syndrome: A Randomized Crossover Trial.,"Prader-Willi syndrome (PWS) is a rare genetic disorder characterized by a wide range of clinical manifestations, including obesity, hyperphagia, and behavioral problems.  Bifidobacterium animalis  subsp.  lactis  strain BPL1 has been shown to improve central adiposity in adults with simple obesity. To evaluate BPL1's effects in children with PWS, we performed a randomized crossover trial among 39 patients (mean age 10.4 years). Participants were randomized to placebo-BPL1 ( n  = 19) or BPL1-placebo ( n  = 20) sequences and underwent a 12-week period with placebo/BPL1 treatments, a 12-week washout period, and a 12-week period with the crossover treatment. Thirty-five subjects completed the study. The main outcome was changes in adiposity, measured by dual-energy X-ray absorptiometry. Secondary outcomes included lipid and glucose metabolism, hyperphagia, and mental health symptoms. Generalized linear modeling was applied to assess differences between treatments. While BPL1 did not modify total fat mass compared to placebo, BPL1 decreased abdominal adiposity in a subgroup of patients older than 4.5 years ( n  = 28). BPL1 improved fasting insulin concentration and insulin sensitivity. Furthermore, we observed modest improvements in some mental health symptoms. A follow-up trial with a longer treatment period is warranted to determine whether BPL1 supplementation can provide a long-term therapeutic approach for children with PWS (ClinicalTrials.gov NCT03548480).",2020,"While BPL1 did not modify total fat mass compared to placebo, BPL1 decreased abdominal adiposity in a subgroup of patients older than 4.5 years ( n  = 28).","['Children and Adolescents with Prader-Willi Syndrome', 'children with PWS', '39 patients (mean age 10.4 years', 'adults with simple obesity', 'Thirty-five subjects completed the study']","['lactis  strain', 'BPL1-placebo', 'lactis  (BPL1) Supplementation', 'placebo/BPL1 treatments', 'placebo-BPL1', 'BPL1', 'placebo, BPL1', 'BPL1 supplementation']","['fasting insulin concentration and insulin sensitivity', 'abdominal adiposity', 'total fat mass', 'lipid and glucose metabolism, hyperphagia, and mental health symptoms', 'mental health symptoms', 'central adiposity', 'changes in adiposity, measured by dual-energy X-ray absorptiometry']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0032897', 'cui_str': 'Prader-Willi syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C5191376', 'cui_str': '10.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0451819', 'cui_str': 'Simple obesity'}, {'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0020505', 'cui_str': 'Overeating'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4551560', 'cui_str': 'Central obesity'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}]",39.0,0.241297,"While BPL1 did not modify total fat mass compared to placebo, BPL1 decreased abdominal adiposity in a subgroup of patients older than 4.5 years ( n  = 28).","[{'ForeName': 'Montse', 'Initials': 'M', 'LastName': 'Amat-Bou', 'Affiliation': 'Institut de Recerca Sant Joan de Déu, 08950 Barcelona, Spain.'}, {'ForeName': 'Sonika', 'Initials': 'S', 'LastName': 'Garcia-Ribera', 'Affiliation': 'Institut de Recerca Sant Joan de Déu, 08950 Barcelona, Spain.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Climent', 'Affiliation': 'Archer Daniels Midland Co-Biopolis, 46980 Valencia, Spain.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Piquer-Garcia', 'Affiliation': 'Department of Endocrinology and Nutrition, Germans Trias i Pujol Research Institute, 08916 Barcelona, Spain.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Corripio', 'Affiliation': ""Service of Pediatric Endocrinology, Parc Taulí Hospital Universitari, Institut d'Investigació i Innovació Parc Taulí I3PT, Universitat Autònoma de Barcelona, 08208 Sabadell, Spain.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Sanchez-Infantes', 'Affiliation': 'Department of Endocrinology and Nutrition, Germans Trias i Pujol Research Institute, 08916 Barcelona, Spain.'}, {'ForeName': 'Laia', 'Initials': 'L', 'LastName': 'Villalta', 'Affiliation': 'Institut de Recerca Sant Joan de Déu, 08950 Barcelona, Spain.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Elias', 'Affiliation': 'Institut de Recerca Sant Joan de Déu, 08950 Barcelona, Spain.'}, {'ForeName': 'Josep C', 'Initials': 'JC', 'LastName': 'Jiménez-Chillarón', 'Affiliation': 'Institut de Recerca Sant Joan de Déu, 08950 Barcelona, Spain.'}, {'ForeName': 'Empar', 'Initials': 'E', 'LastName': 'Chenoll', 'Affiliation': 'Archer Daniels Midland Co-Biopolis, 46980 Valencia, Spain.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Ramón', 'Affiliation': 'Archer Daniels Midland Co-Biopolis, 46980 Valencia, Spain.'}, {'ForeName': 'Lourdes', 'Initials': 'L', 'LastName': 'Ibañez', 'Affiliation': 'Institut de Recerca Sant Joan de Déu, 08950 Barcelona, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Ramon-Krauel', 'Affiliation': 'Institut de Recerca Sant Joan de Déu, 08950 Barcelona, Spain.'}, {'ForeName': 'Carles', 'Initials': 'C', 'LastName': 'Lerin', 'Affiliation': 'Institut de Recerca Sant Joan de Déu, 08950 Barcelona, Spain.'}]",Nutrients,['10.3390/nu12103123']
1576,33066601,Acute Effects of Self-Selected Music Intervention on Golf Performance and Anxiety Level in Collegiate Golfers: A Crossover Study.,"Music has been reported as a positive intervention for improving psychophysiological conditions and exercise performance. However, the effects of music intervention on golf performance in association with psychophysiological responses have not been well examined in the literature. The purpose of the study was to investigate the acute effects of self-selected music intervention on golf swing and putting performance, heart rate (HR), HR variability (HRV), and anxiety. Twenty collegiate golfers voluntarily participated in this study (age = 20.2 ± 1.4 years, height = 171.7 ± 8.0 cm, body weight = 69.5 ± 14.6 kg, golf experience = 7.5 ± 2.1 years). A cross-over and within-subject design was used in this study. Participants performed a non-music trial (T1), pre-exercise music trial (T2), and simultaneous music trial (T3) in a randomized order with 48-72 h apart. The participants were attached to a HR monitor to record the HR and HRV during the measurement. The golf swing and putting performance was assessed by using the Golfzon golf simulator system. The state-trait anxiety inventory-state questionnaire (STAI-S) was used to evaluate anxiety state. All measurements were taken during baseline (phase one) and after resting or music intervention (phase two). Repeated measurement of analysis of variance (ANOVA) and Cohen's effect size (ES) were used for statistical analyses. The results show no significant differences in golf swing and putting performance ( p  > 0.05). However, significant decrease in STAI-S score was found in T2 ( p  = 0.047, ES = 0.32). A significant increase in the standard deviation of normal R-R interval (SDNN), low-frequency power spectrum (LF), standard deviation of along the line-of-identity (SD2) in T2 and T3 were observed ( p  < 0.05). In conclusion, a single pre-exercise or simultaneous self-selected music intervention contributes minor effects to golf performance in collegiate golfers. The positive benefits of self-selected music intervention on the psychological condition and cardia-related modulation while practicing golf is warranted.",2020,"A significant increase in the standard deviation of normal R-R interval (SDNN), low-frequency power spectrum (LF), standard deviation of along the line-of-identity (SD2) in T2 and T3 were observed ( p  < 0.05).","['Twenty collegiate golfers voluntarily participated in this study (age = 20.2 ± 1.4 years, height = 171.7 ± 8.0 cm, body weight = 69.5 ± 14.6 kg, golf experience = 7.5 ± 2.1 years', 'Collegiate Golfers']","['Self-Selected Music Intervention', 'self-selected music intervention', 'music intervention']","['STAI-S score', 'golf swing and putting performance', 'standard deviation of normal R-R interval (SDNN), low-frequency power spectrum (LF), standard deviation of along the line-of-identity (SD2', 'Golf Performance and Anxiety Level', 'golf swing and putting performance, heart rate (HR), HR variability (HRV), and anxiety', 'state-trait anxiety inventory-state questionnaire (STAI-S']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517642', 'cui_str': '20.2'}, {'cui': 'C4517503', 'cui_str': '1.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0018041', 'cui_str': 'Golfing'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C4068876', 'cui_str': '2.1'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018041', 'cui_str': 'Golfing'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0424215', 'cui_str': 'Sense of identity'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.0512171,"A significant increase in the standard deviation of normal R-R interval (SDNN), low-frequency power spectrum (LF), standard deviation of along the line-of-identity (SD2) in T2 and T3 were observed ( p  < 0.05).","[{'ForeName': 'Hung-Tsung', 'Initials': 'HT', 'LastName': 'Wang', 'Affiliation': 'Graduate Institute of Sports Training, University of Taipei, Taipei 11153, Taiwan.'}, {'ForeName': 'Hsia-Ling', 'Initials': 'HL', 'LastName': 'Tai', 'Affiliation': 'Department of Physical Education, University of Taipei, Taipei 10048, Taiwan.'}, {'ForeName': 'Chia-Chen', 'Initials': 'CC', 'LastName': 'Yang', 'Affiliation': 'Graduate Institute of Sports Training, University of Taipei, Taipei 11153, Taiwan.'}, {'ForeName': 'Yung-Sheng', 'Initials': 'YS', 'LastName': 'Chen', 'Affiliation': 'Department of Exercise and Health Sciences, University of Taipei, Taipei 11153, Taiwan.'}]",International journal of environmental research and public health,['10.3390/ijerph17207478']
1577,33066735,The skill of tracheal intubation with rigid scopes - a randomised controlled trial comparing learning curves in 740 intubations.,"BACKGROUND


Rigid scopes are successfully used for management of difficult airways, but learning curves have not been established.
METHODS


This randomised controlled trial was performed at the University Hospital Bern in Switzerland to establish learning curves for the rigid scopes Bonfils and SensaScope and to assess their performance. Fifteen consultant anaesthetists and 15 anaesthesia registrars performed a total of 740 intubations (10 to 20 intubations with each device per physician) in adult patients without predictors of a difficult airway under general anaesthesia. According to randomisation, physicians intubated the patient's trachea with either the Bonfils or the SensaScope. A maximum of three intubation attempts was allowed. Primary outcome was overall time to successful intubation. Secondary outcome parameters included first attempt success, first attempt success within 60 s, failures and adverse events.
RESULTS


A clear learning effect was demonstrated: Over 20 trials, intubations became 2.5-times quicker and first attempt intubation success probability increased by 21-28 percentage points. Fourteen and 20 trials were needed with the Bonfils and the SensaScope, respectively, to reach a 90% first attempt success probability. Intubation times were 23% longer (geometric mean ratio 1.23, 95% confidence interval 1.12-1.36, p < 0.001) and first attempt success was less likely (odds ratio 0.64, 95% confidence interval 0.45-0.92, p = 0.016) with the SensaScope. Consultants showed a tendency for a better first attempt success compared to registrars. Overall, 23 intubations (10 Bonfils, 13 SensaScope) failed. Adverse events were rare and did not differ between devices.
CONCLUSIONS


A clear learning effect was demonstrated for both rigid scopes. Fourteen intubations with the Bonfils and 20 intubations with the SensaScope were required to reach a 90% first attempt success probability. Learning of the technique seemed more complex with the SensaScope compared to the Bonfils.
TRIAL REGISTRATION


Current Controlled Trials, ISRCTN14429285 . Registered 28 September 2011, retrospectively registered.",2020,"Intubation times were 23% longer (geometric mean ratio 1.23, 95% confidence interval 1.12-1.36, p < 0.001) and first attempt success was less likely (odds ratio 0.64, 95% confidence interval 0.45-0.92, p = 0.016) with the SensaScope.","['Fifteen consultant anaesthetists and 15 anaesthesia registrars performed a total of 740 intubations (10 to 20 intubations with each device per physician) in adult patients without predictors of a difficult airway under general anaesthesia', '740 intubations']",[],"['overall time to successful intubation', 'Intubation times', 'intubation success probability', 'Adverse events', 'first attempt success, first attempt success within 60\u2009s, failures and adverse events']","[{'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0557514', 'cui_str': 'Registrar'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332218', 'cui_str': 'Difficult'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]",[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0231174', 'cui_str': 'Failure'}]",,0.176883,"Intubation times were 23% longer (geometric mean ratio 1.23, 95% confidence interval 1.12-1.36, p < 0.001) and first attempt success was less likely (odds ratio 0.64, 95% confidence interval 0.45-0.92, p = 0.016) with the SensaScope.","[{'ForeName': 'Lorenz', 'Initials': 'L', 'LastName': 'Theiler', 'Affiliation': 'Department of Anaesthesia, Cantonal Hospital Aarau, Aarau, Switzerland.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Greif', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Inselspital, Bern University Hospital, University of Bern, 3010, Bern, Switzerland.'}, {'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Bütikofer', 'Affiliation': 'CTU Bern, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Kristopher', 'Initials': 'K', 'LastName': 'Arheart', 'Affiliation': 'Department of Public Health Sciences, University of Miami Miller School of Medicine, Miami, Florida, USA.'}, {'ForeName': 'Maren', 'Initials': 'M', 'LastName': 'Kleine-Brueggeney', 'Affiliation': ""Department of Anaesthesia, University Children's Hospital Zurich - Eleonore Foundation and University of Zurich, Steinwiesstrasse 75, 8032, Zurich, Switzerland. maren.kleinebrueggeney@gmail.com.""}]",BMC anesthesiology,['10.1186/s12871-020-01181-w']
1578,33066746,Collaborative model of care between Orthopaedics and allied healthcare professionals in knee osteoarthritis (CONNACT): study protocol for an effectiveness-implementation hybrid randomized control trial.,"BACKGROUND


Knee Osteoarthritis (OA) is a leading cause of global disability. The Collaborative Model of Care between Orthopaedics and Allied Healthcare Professionals (CONNACT) Model of Care (MoC) was developed by optimizing evidence-based non-surgical treatments to deliver value-based care for people with knee OA. The primary aim of this study is to determine the clinical effectiveness of the CONNACT MoC (3 months) compared to usual care. The secondary aims are: a) To determine the cost-effectiveness and b) To develop an evaluation and implementation framework to inform large scale implementation for this MoC.
METHODOLOGY


Type 1 Effectiveness-Implementation Hybrid Trial using an explanatory sequential mixed-method approach. The study consists of 3 components. The first component is the pragmatic, parallel-arm, single-blinded randomized control trial. Inclusion criteria are patients with knee OA based on the National Institute of Health and Care Excellence (NICE) criteria with radiographic severity of greater than Kellgren-Lawrence 1, and Knee Injury and OA Outcome Score (KOOS 4 ) of equal or less than 75. Exclusion criteria include other forms of arthritis, history of previous knee arthroplasty or wheelchair-bound patient. KOOS 4  is the primary outcome measure at 3 months, 6 months and 1 year. Secondary outcomes include KOOS individual subscales, quality of life scoring, functional performance, global, diet and psychological related outcomes. The second component is an economic evaluation of the cost-effectiveness of the CONNACT MoC using a societal perspective. The third component is an implementation and evaluation framework using process evaluation under the RE-AIM framework using a mixed-method approach. Sample size of 100 patients has been calculated.
DISCUSSION


CONNACT MoC is a complex intervention. In line with the MRC guidance for developing and evaluating complex interventions, a pilot feasibility study was completed and a comprehensive approach including an RCT, economic evaluation and process evaluation is described in this study protocol. Results from this study will help clinicians, healthcare administrators and policymakers guide the sustainable and effective implementation of the CONNACT MoC for knee OA and serve as a basis for similar multidisciplinary MoC for chronic degenerative musculoskeletal conditions to be developed.
TRIAL REGISTRATION


Clinicaltrials.gov Identifier: NCT03809975 . Registered January 182,019.",2020,The Collaborative Model of Care between Orthopaedics and Allied Healthcare Professionals (CONNACT),"['Knee Osteoarthritis (OA', 'patients with knee OA based on the National Institute of Health and Care Excellence (NICE) criteria with radiographic severity of greater than Kellgren-Lawrence 1, and Knee Injury and OA Outcome Score (KOOS 4 ) of equal or less than 75', 'knee osteoarthritis (CONNACT', 'people with knee OA']","['CONNACT MoC', 'Allied Healthcare Professionals (CONNACT']","['KOOS individual subscales, quality of life scoring, functional performance, global, diet and psychological related outcomes']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0022744', 'cui_str': 'Injury of knee'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0018724', 'cui_str': 'Health Care Providers'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.0937334,The Collaborative Model of Care between Orthopaedics and Allied Healthcare Professionals (CONNACT),"[{'ForeName': 'Bryan Yijia', 'Initials': 'BY', 'LastName': 'Tan', 'Affiliation': 'Department of Orthopaedic Surgery, Woodlands Health Campus, National Healthcare Group, Singapore, Singapore. btanyj@hotmail.com.'}, {'ForeName': 'Michelle Jessica', 'Initials': 'MJ', 'LastName': 'Pereira', 'Affiliation': 'Health Services Outcome Research, National Healthcare Group, Singapore City, Singapore.'}, {'ForeName': 'Su-Yin', 'Initials': 'SY', 'LastName': 'Yang', 'Affiliation': 'Department of Orthopaedic Surgery, Woodlands Health Campus, National Healthcare Group, Singapore, Singapore.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Hunter', 'Affiliation': 'Institute of Bone and Joint Research, Kolling Institute, University of Sydney and Rheumatology Department, Royal North Shore Hospital, Sydney, Australia.'}, {'ForeName': 'Soren Thorgaard', 'Initials': 'ST', 'LastName': 'Skou', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, Research Unit for Musculoskeletal Function and Physiotherapy, University of Southern Denmark, Odense M, Denmark.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Thumboo', 'Affiliation': 'Singapore General Hospital, Singapore City, Singapore.'}, {'ForeName': 'Josip', 'Initials': 'J', 'LastName': 'Car', 'Affiliation': 'Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore City, Singapore.'}]",BMC musculoskeletal disorders,['10.1186/s12891-020-03695-3']
1579,33067121,Mobile health technology-supported atrial fibrillation screening and integrated care: A report from the mAFA-II trial Long-term Extension Cohort.,"BACKGROUND


In the mobile Atrial Fibrillation App (mAFA)-II trial, the use of mobile health (mHealth) technology, incorporating AF screening and integrated management strategy, was associated with improved short-term clinical outcomes. The aim of this study was to report adherence/persistence and long term (≥1 year) clinical outcomes of the mAFA-II trial, with mHealth-supported optimised stroke prevention, symptom control and comorbidity management.
METHODS


We studied an adult population screened for AF, where identified patients could enter a structured program of holistic and integrated care based on the ABC (Atrial fibrillation Better Care) pathway using mHealth with a mAFA intervention. In this cluster randomised trial, comparing mHeath intervention to usual care, the primary composite outcome was 'stroke/thromboembolism, all-cause death and rehospitalization'.
RESULTS


The 1261 subjects (mean age 67.0 years, 38.0% female) who were followed up over one year (mean follow-up 687 (standard deviation, SD 191) days) in the intervention arm, had a lower risk of the composite outcome of 'ischaemic stroke/systemic thromboembolism, death, and rehospitalization' (hazard ratio, HR 0.18, 95% confidence interval, CI: 0.13-0.25, P < 0.001), compared to usual care (1212 subjects, mean age 70.1 years, 42.1% female). Of 842 patients using their smart devices for 'Better symptom management', 70.8% had good management adherence (monitoring time/follow-up since initial monitoring ≥ 70%), with the persistence of use of 91.7%.
CONCLUSION


Amongst AF patients with long term use (≥1 year) of mHealth technology for optimising stroke prevention, symptom control and comorbidity management, adherence/persistence was good and associated with a reduction in adverse clinical outcomes.",2020,"Amongst AF patients with long term use (≥1 year) of mHealth technology for optimising stroke prevention, symptom control and comorbidity management, adherence/persistence was good and associated with a reduction in adverse clinical outcomes.","[""842 patients using their smart devices for 'Better symptom management', 70.8% had"", '1261 subjects (mean age 67.0 years, 38.0% female', 'hazard ratio, HR 0.18, 95% confidence interval, CI: 0.13-0.25, P < 0.001), compared to usual care (1212 subjects, mean age 70.1 years, 42.1% female', 'adult population screened for AF, where identified patients could enter a structured program of holistic and integrated care based on the ABC (Atrial fibrillation Better Care) pathway using mHealth with a mAFA intervention']",['Mobile health technology-supported atrial fibrillation screening and integrated care'],"['stroke/thromboembolism, all-cause death and rehospitalization', 'good management adherence', ""lower risk of the composite outcome of 'ischaemic stroke/systemic thromboembolism, death, and rehospitalization""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C4517433', 'cui_str': '0.18'}, {'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}, {'cui': 'C4517428', 'cui_str': '0.13'}, {'cui': 'C4517443', 'cui_str': '0.25'}, {'cui': 'C4517385', 'cui_str': '0.001'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1269815', 'cui_str': 'Patient identification'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0152244', 'cui_str': 'Aneurysmal bone cyst'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}]",,0.11083,"Amongst AF patients with long term use (≥1 year) of mHealth technology for optimising stroke prevention, symptom control and comorbidity management, adherence/persistence was good and associated with a reduction in adverse clinical outcomes.","[{'ForeName': 'Yutao', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Department of Cardiology, Chinese PLA General Hospital, Beijing, China; Liverpool Centre for Cardiovascular Sciences, University of Liverpool, Liverpool, United Kingdom; and Aalborg Thrombosis Research Unit, Department of Clinical Medicine, Aalborg University, Aalborg, Denmark. Electronic address: dor_guoyt@hotmail.com.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': 'Department of Cardiology, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Xiangmin', 'Initials': 'X', 'LastName': 'Shi', 'Affiliation': 'Department of Cardiology, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Yao', 'Affiliation': 'Institute for Hospital Management Research, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Yihong', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Yunlong', 'Initials': 'Y', 'LastName': 'Xia', 'Affiliation': 'Department of Cardiology, First Affiliated Hospital of Dalian Medical University, Dalian, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Yu', 'Affiliation': 'Department of Cardiology, First Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Liu', 'Affiliation': 'Tianjin Key Laboratory of Ionic-Molecular Function of Cardiovascular Disease, Tianjin Institute of Cardiology, Second Hospital of Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Yundai', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiology, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Gregory Y H', 'Initials': 'GYH', 'LastName': 'Lip', 'Affiliation': 'Department of Cardiology, Chinese PLA General Hospital, Beijing, China; Liverpool Centre for Cardiovascular Sciences, University of Liverpool, Liverpool, United Kingdom; and Aalborg Thrombosis Research Unit, Department of Clinical Medicine, Aalborg University, Aalborg, Denmark. Electronic address: gregory.lip@liverpool.ac.uk.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European journal of internal medicine,['10.1016/j.ejim.2020.09.024']
1580,33067278,Effect of 12-week pulmonary rehabilitation on cognitive function in patients with stable chronic obstructive pulmonary disease: study protocol for a single-center randomised controlled trial.,"INTRODUCTION


Cognitive impairment, an important complication in patients with chronic obstructive pulmonary disease (COPD), seriously affects self-management of the disease and quality of life (QoL). As an exercise-based intervention programme, pulmonary rehabilitation (PR)-especially aerobic exercise (mainly mind-body exercise) and resistance exercise (RE)-has been proposed for its potential effectiveness in improving cognitive function. However, there is still a lack of strong evidence for PR's effectiveness. In this study, we expect to clarify the effects of pulmonary-based Qigong exercise and elastic band-based RE on cognitive function in patients with COPD and to fill in the relevant evidence blanks.
METHODS AND ANALYSIS


This study is a single-centre randomised controlled trial with assessor and data analyst blinding. We will recruit 108 participants with stable COPD starting on 23 December 2019, and randomly allocate them into the pulmonary-based Qigong exercise group, elastic band-based RE group, pulmonary-based Qigong exercise and elastic band-based RE combined group, or control group at a 1:1:1:1 ratio. Participants in intervention groups will perform 30 min of exercise two times per day, 5 days a week, for 12 weeks. The primary outcome will be the global cognitive function as assessed by the Montreal Cognitive Assessment and auditory event-related potential P300. Secondary outcomes will include the specific cognitive domains-attention, memory, executive function, verbal fluency and mental-processing speed; psychological functions and QoL. Exploratory outcomes will include grey matter volume and levels of inflammatory mediators. Outcomes will be measured before and after the interventions.
ETHICS AND DISSEMINATION


Ethics approval has been granted by the Ethics Committee of Yue-Yang Integrative Medicine Hospital, an affiliate of Shanghai University of Traditional Chinese Medicine, Shanghai, China (Grant No. 2019-141). Written informed consent will be obtained from each participant before any procedures are performed. The findings will be published in peer-reviewed journals and presented at academic conferences.
TRIAL REGISTRATION NUMBER


ChiCTR1900026869; pre-results.",2020,"Secondary outcomes will include the specific cognitive domains-attention, memory, executive function, verbal fluency and mental-processing speed; psychological functions and QoL. Exploratory outcomes will include grey matter volume and levels of inflammatory mediators.","['108 participants with stable COPD starting on 23 December 2019', 'patients with stable chronic obstructive pulmonary disease', 'patients with COPD and to fill in the relevant evidence blanks', 'patients with chronic obstructive pulmonary disease (COPD']","['pulmonary-based Qigong exercise and elastic band-based RE', 'pulmonary-based Qigong exercise group, elastic band-based RE group, pulmonary-based Qigong exercise and elastic band-based RE combined group, or control group', 'pulmonary rehabilitation', 'exercise-based intervention programme, pulmonary rehabilitation (PR)-especially aerobic exercise (mainly mind-body exercise) and resistance exercise (RE)-has']","['specific cognitive domains-attention, memory, executive function, verbal fluency and mental-processing speed; psychological functions and QoL. Exploratory outcomes will include grey matter volume and levels of inflammatory mediators', 'global cognitive function as assessed by the Montreal Cognitive Assessment and auditory event-related potential P300', 'cognitive function']","[{'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0282077', 'cui_str': 'Qigong'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0221839', 'cui_str': 'Orthodontic band, elastic'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0025361', 'cui_str': 'Form of thinking'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0233398', 'cui_str': 'Psychological function'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0018220', 'cui_str': 'Grey Matter'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0282171', 'cui_str': 'Event-related potentials'}, {'cui': 'C0444781', 'cui_str': 'P300 (P3)'}]",108.0,0.121401,"Secondary outcomes will include the specific cognitive domains-attention, memory, executive function, verbal fluency and mental-processing speed; psychological functions and QoL. Exploratory outcomes will include grey matter volume and levels of inflammatory mediators.","[{'ForeName': 'Hongxia', 'Initials': 'H', 'LastName': 'Duan', 'Affiliation': 'School of Rehabilitation Science, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Peijun', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': 'Department of Sports Medicine, Shanghai University of Sport, Shanghai, China.'}, {'ForeName': 'Zhenwei', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Respiratory Medicine, Shanghai University of Traditional Chinese Medicine Yueyang Hospital of Integrated Traditional Chinese Medicine and Western Medicine, Shanghai, China.'}, {'ForeName': 'Haixia', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Sports Medicine, Shanghai University of Sport, Shanghai, China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': 'Department of Sports Medicine, Shanghai University of Sport, Shanghai, China.'}, {'ForeName': 'Weibing', 'Initials': 'W', 'LastName': 'Wu', 'Affiliation': 'Department of Sports Medicine, Shanghai University of Sport, Shanghai, China.'}, {'ForeName': 'Xiaodan', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'School of Rehabilitation Science, Shanghai University of Traditional Chinese Medicine, Shanghai, China hzhp403@126.com.'}]",BMJ open,['10.1136/bmjopen-2020-037307']
1581,33068344,[Immediate effect of acupuncture and moxibustion at Guanyuan (CV 4) and Zusanli (ST 36) on heart rate variability in patients with  qi  deficiency syndrome].,"OBJECTIVE


To compare the immediate effect of acupuncture and moxibustion at Guanyuan (CV 4) and Zusanli (ST 36) on heart rate variability index in patients with  qi  deficiency syndrome.
METHODS


Ninety patients with  qi  deficiency syndrome were randomly divided into an acupuncture group, a moxibustion group and a blank group, 30 patients in each group. The patients in the acupuncture group were treated with acupuncture at Guanyuan (CV 4) and Zusanli (ST 36) for 15 min; acupuncture was given once. The patients in the moxibustion group were treated with moxibustion with identical acupoints and treatment duration. The patients in the blank group received no intervention. The symptom scores of  qi  deficiency syndrome in each group before and after treatment were recorded. The average heart rate and index of heart rate variability including total power, low frequency (LF), high frequency (HF) and logarithm of LF/HF (log LF/HF) were tested 5 min before treatment, 5 min, 10 min, 15 min into treatment, and 5 min after treatment.
RESULTS


The symptom scores of  qi  deficiency syndrome were reduced in the acupuncture group and moxibustion group after treatment ( P <0.05). Compared before treatment, in the acupuncture group, the HF was increased 5 min into treatment ( P <0.05), but was reduced 15 min into treatment and 5 min after treatment ( P <0.05,  P <0.01). The log LF/HF was increased 5 min and 10 min into treatment and 5 min after treatment ( P <0.01). The difference of average heart rate between 5 min before treatment and 5 min after treatment in the acupuncture group was higher than that in the moxibustion group and blank group ( P <0.05), and the difference of log LF/HF was higher than that in the moxibustion group and blank group ( P <0.05,  P <0.01).
CONCLUSION


Acupuncture and moxibustion has immediate effects on heart rate variability in patients with  qi  deficiency syndrome, and the effect of acupuncture is superior to moxibustion, which may be related to the benign regulation of acupuncture on autonomic nervous system.",2020,"Compared before treatment, in the acupuncture group, the HF was increased 5 min into treatment ( P <0.05), but was reduced 15 min into treatment and 5 min after treatment ( P <0.05,  P <0.01).","['patients with  qi  deficiency syndrome', 'Ninety patients with  qi  deficiency syndrome']","['Acupuncture and moxibustion', 'moxibustion with identical acupoints and treatment duration', 'acupuncture and moxibustion at Guanyuan (CV 4) and Zusanli (ST 36', 'acupuncture', 'acupuncture at Guanyuan (CV 4) and Zusanli (ST 36) for 15 min; acupuncture', 'moxibustion group and a blank group']","['log LF/HF', 'symptom scores of  qi  deficiency syndrome', 'average heart rate', 'heart rate variability index', 'average heart rate and index of heart rate variability including total power, low frequency (LF), high frequency (HF) and logarithm of LF/HF', 'HF', 'heart rate variability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C3816959', 'cui_str': '90'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0026652', 'cui_str': 'Moxibustion'}, {'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C0001302', 'cui_str': 'Acupuncture point'}, {'cui': 'C0444921', 'cui_str': 'Duration of treatment'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}]",90.0,0.0477659,"Compared before treatment, in the acupuncture group, the HF was increased 5 min into treatment ( P <0.05), but was reduced 15 min into treatment and 5 min after treatment ( P <0.05,  P <0.01).","[{'ForeName': 'Yan-Juan', 'Initials': 'YJ', 'LastName': 'Song', 'Affiliation': 'College of Acupuncture-Moxibustion and Orthopaedics of Hubei University of CM, Preventive Treatment of Acupuncture and Moxibustion of Hubei Provincial Collaborative Innovation Center, Wuhan 430061, China.'}, {'ForeName': 'Feng-Xia', 'Initials': 'FX', 'LastName': 'Liang', 'Affiliation': 'College of Acupuncture-Moxibustion and Orthopaedics of Hubei University of CM, Preventive Treatment of Acupuncture and Moxibustion of Hubei Provincial Collaborative Innovation Center, Wuhan 430061, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'College of Acupuncture-Moxibustion and Orthopaedics of Hubei University of CM, Preventive Treatment of Acupuncture and Moxibustion of Hubei Provincial Collaborative Innovation Center, Wuhan 430061, China.'}, {'ForeName': 'Litscher', 'Initials': 'L', 'LastName': 'Gerhard', 'Affiliation': 'Traditional Medicine Research Center, Medical University of Graz, Graz 8036, Austria.'}, {'ForeName': 'Song', 'Initials': 'S', 'LastName': 'Wu', 'Affiliation': 'College of Acupuncture-Moxibustion and Orthopaedics of Hubei University of CM, Preventive Treatment of Acupuncture and Moxibustion of Hubei Provincial Collaborative Innovation Center, Wuhan 430061, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'College of Acupuncture-Moxibustion and Orthopaedics of Hubei University of CM, Preventive Treatment of Acupuncture and Moxibustion of Hubei Provincial Collaborative Innovation Center, Wuhan 430061, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Huang', 'Affiliation': 'College of Acupuncture-Moxibustion and Orthopaedics of Hubei University of CM, Preventive Treatment of Acupuncture and Moxibustion of Hubei Provincial Collaborative Innovation Center, Wuhan 430061, China.'}, {'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'College of Acupuncture-Moxibustion and Orthopaedics of Hubei University of CM, Preventive Treatment of Acupuncture and Moxibustion of Hubei Provincial Collaborative Innovation Center, Wuhan 430061, China.'}, {'ForeName': 'Ru-Feng', 'Initials': 'RF', 'LastName': 'Teng', 'Affiliation': 'College of Acupuncture-Moxibustion and Orthopaedics of Hubei University of CM, Preventive Treatment of Acupuncture and Moxibustion of Hubei Provincial Collaborative Innovation Center, Wuhan 430061, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'College of Acupuncture-Moxibustion and Orthopaedics of Hubei University of CM, Preventive Treatment of Acupuncture and Moxibustion of Hubei Provincial Collaborative Innovation Center, Wuhan 430061, China.'}, {'ForeName': 'Xiang-Lin', 'Initials': 'XL', 'LastName': 'Chen', 'Affiliation': 'College of Acupuncture-Moxibustion and Orthopaedics of Hubei University of CM, Preventive Treatment of Acupuncture and Moxibustion of Hubei Provincial Collaborative Innovation Center, Wuhan 430061, China.'}]",Zhongguo zhen jiu = Chinese acupuncture & moxibustion,['10.13703/j.0255-2930.20190727-k0003']
1582,33068345,[Scraping on head and face combined with stepping technique of  tuina  along lower limbs for chronic fatigue syndrome].,"OBJECTIVE


To observe the effect of scraping on head and face combined with stepping technique of  tuina  along lower limbs on fatigue symptom and mental state in patients with chronic fatigue syndrome.
METHODS


A total of 100 patients with chronic fatigue syndrome were randomized into an observation group (50 cases, 2 cases dropped off) and a control group (50 cases, 2 cases dropped off). In the control group, oryzanol tablets and compound vitamin B tablets were taken orally, both 2 tablets every time, 3 times every day for 30 days. On the basis of the treatment in the control group, scraping on head and face combined with stepping technique of  tuina  along lower limbs of three  yin  meridians of foot were applied in the observation group, once every 3 days, 10 times were required. Before and after treatment, the scores of fatigue scale-14 (FS-14) and somatic and psychological health report (SPHERE) were observed, and the clinical therapeutic effect was evaluated in the two groups.
RESULTS


After treatment, the scores of FS-14 and SPHERE were reduced in the two groups ( P <0.05), and the changes of those indexes in the observation group were larger than the control group ( P <0.05). The total effective rate was 91.7% (44/48) in the observation group, which was superior to 54.2% (26/48) in the control group ( P <0.05).
CONCLUSION


Scraping on head and face combined with stepping technique of  tuina  along lower limbs can improve fatigue symptom and mental state in patients with chronic fatigue syndrome.",2020,"After treatment, the scores of FS-14 and SPHERE were reduced in the two groups ( P <0.05), and the changes of those indexes in the observation group were larger than the control group ( P <0.05).","['100 patients with chronic fatigue syndrome', 'patients with chronic fatigue syndrome', 'chronic fatigue syndrome']","['stepping technique of  tuina  along lower limbs', 'oryzanol tablets and compound vitamin B tablets', 'Scraping on head and face combined with stepping technique of  tuina']","['total effective rate', 'clinical therapeutic effect', 'fatigue symptom and mental state', 'scores of FS-14 and SPHERE', 'scores of fatigue scale-14 (FS-14) and somatic and psychological health report (SPHERE']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015674', 'cui_str': 'Chronic fatigue syndrome'}]","[{'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0061081', 'cui_str': 'gamma-oryzanol'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0205198', 'cui_str': 'Compound'}, {'cui': 'C0042849', 'cui_str': 'Vitamin B Complex'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0278060', 'cui_str': 'Mental state'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332501', 'cui_str': 'Spherical shape'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1257909', 'cui_str': 'Diploid Cell'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0684224', 'cui_str': 'Report'}]",100.0,0.0230917,"After treatment, the scores of FS-14 and SPHERE were reduced in the two groups ( P <0.05), and the changes of those indexes in the observation group were larger than the control group ( P <0.05).","[{'ForeName': 'Long-Ming', 'Initials': 'LM', 'LastName': 'Lei', 'Affiliation': 'Department of Tuina, First Affiliated Hospital of Guangxi University of CM, Nanning 530023, China.'}, {'ForeName': 'Qiong-Yuan', 'Initials': 'QY', 'LastName': 'Wu', 'Affiliation': 'First Clinical Medical College, Guangxi University of CM.'}, {'ForeName': 'Yu-Feng', 'Initials': 'YF', 'LastName': 'He', 'Affiliation': 'Department of Tuina, First Affiliated Hospital of Guangxi University of CM, Nanning 530023, China.'}]",Zhongguo zhen jiu = Chinese acupuncture & moxibustion,['10.13703/j.0255-2930.20190801-k0006']
1583,33068346,"[Acupuncture of ""Zhibian (BL 54) through Shuidao (ST 28)"" for female stress urinary incontinence: a randomized controlled trial].","OBJECTIVE


To observe effect of ""Zhibian (BL 54) through Shuidao (ST 28)"" acupuncture for quality of life of female patients with stress urinary incontinence.
METHODS


A total of 90 female patients were randomly divided into an observation group and a control group, 45 cases in each group. The patients in the observation group were treated with ""Zhibian (BL 54) through Shuidao (ST 28)"" acupuncture method, and the patients in the control group were treated with non-permeable sham acupuncture at Zhibian (BL 54). The needles were retained for 30 min in both groups, once a day, and the treatment was totally given 10 times. The score of urinary incontinence quality of life questionnaire (I-QOL) was recorded before and after treatment and during the follow-up 1 month after treatment in the two groups, and the 1 h urine pad test and the 72 h urination diary card were used to evaluate the 1 h urine leakage and the 24 h urine leakage frequency of the two groups.
RESULTS


After treatment and during follow-up, the I-QOL scores in the observation group were higher than those before treatment ( P <0.05), and were higher than those in the control group ( P <0.05). After treatment and during follow-up, the 1 h urine leakage and the 24 h urine leakage frequency in the observation group were lower than those before treatment ( P <0.05), and less than those in the control group ( P <0.05).
CONCLUSION


Acupuncture of ""Zhibian (BL 54) through Shuidao (ST 28)"" can improve the quality of life of female patients with stress urinary incontinence, and improve the volume and frequency of urine leakage.",2020,"After treatment and during follow-up, the I-QOL scores in the observation group were higher than those before treatment ( P <0.05), and were higher than those in the control group ( P <0.05).","['female patients with stress urinary incontinence', 'female stress urinary incontinence', '90 female patients']","['Acupuncture of ""Zhibian (BL 54) through Shuidao (ST 28', 'non-permeable sham acupuncture', 'Zhibian (BL 54) through Shuidao (ST 28)"" acupuncture', 'Zhibian (BL 54) through Shuidao (ST 28)"" acupuncture method']","['quality of life', 'QOL scores', 'score of urinary incontinence quality of life questionnaire (I-QOL', 'urine leakage frequency']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042025', 'cui_str': 'Genuine stress incontinence'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0332242', 'cui_str': 'Non-permeable'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0152245', 'cui_str': 'Extravasation of urine'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",90.0,0.0210558,"After treatment and during follow-up, the I-QOL scores in the observation group were higher than those before treatment ( P <0.05), and were higher than those in the control group ( P <0.05).","[{'ForeName': 'Hai-Jun', 'Initials': 'HJ', 'LastName': 'Wang', 'Affiliation': 'Third Clinical College of Shanxi University of CM, Jinzhong 030619, China.'}, {'ForeName': 'Yu-Xia', 'Initials': 'YX', 'LastName': 'Cao', 'Affiliation': 'Third Department of Acupuncture and Moxibustion, Acupuncture Hospital of Shanxi Province.'}, {'ForeName': 'Jun-Qiang', 'Initials': 'JQ', 'LastName': 'Ji', 'Affiliation': 'Department of Neurology, Shanxi Province Hospital of Integrated Traditional and Western Medcine.'}, {'ForeName': 'Pei-Rui', 'Initials': 'PR', 'LastName': 'Nie', 'Affiliation': 'Third Department of Acupuncture and Moxibustion, Acupuncture Hospital of Shanxi Province.'}, {'ForeName': 'Jian-Chao', 'Initials': 'JC', 'LastName': 'Wang', 'Affiliation': 'Third Department of Acupuncture and Moxibustion, Acupuncture Hospital of Shanxi Province.'}, {'ForeName': 'Xiao-Yan', 'Initials': 'XY', 'LastName': 'Chen', 'Affiliation': 'Third Department of Acupuncture and Moxibustion, Acupuncture Hospital of Shanxi Province.'}, {'ForeName': 'Rang-Qian', 'Initials': 'RQ', 'LastName': 'Li', 'Affiliation': 'Third Department of Acupuncture and Moxibustion, Acupuncture Hospital of Shanxi Province.'}, {'ForeName': 'Xiao-Ying', 'Initials': 'XY', 'LastName': 'Zhang', 'Affiliation': 'Third Department of Acupuncture and Moxibustion, Acupuncture Hospital of Shanxi Province.'}, {'ForeName': 'Lai-Xi', 'Initials': 'LX', 'LastName': 'Ji', 'Affiliation': 'Third Clinical College of Shanxi University of CM, Jinzhong 030619, China.'}]",Zhongguo zhen jiu = Chinese acupuncture & moxibustion,['10.13703/j.0255-2930.20200410-k0005']
1584,33068347,[Medicated plaster at Dazhui (GV 14) for preventing perioperative hypothermia in patients undergoing PKRP and ureteroscopic laser lithotripsy].,"OBJECTIVE


To observe the preventive effect of medicated plaster at Dazhui (GV 14) on preventing perioperative hypothermia in patients undergoing plasmakinetic resection of prostate (PKRP) and ureteroscopic laser lithotripsy.
METHODS


A total of 300 patients with ASA gradeⅠorⅡreceiving ureteroscopic laser lithotripsy or PKRP under total intravenous anesthesia (TIVA) were randomly divided into an observation group and a control group, 150 cases in each group. The patients in the control group received routine heat preservation measures, while on the basis of the control group, the patients in the observation group were treated with medicated plaster at Dazhui (GV 14) 30 min before operation. The temperature (ear temperature), mean arterial pressure (MAP), heart rate and blood oxygen saturation (SpO 2 ) at each time point (resting state before operation, 5, 10 min into operation, at the end of operation, 5 and 10 min after operation) were recorded; the number of hypothermia, the classification of postoperative shivering degree, operation time, propofol dosage, intraoperative infusion volume and intraoperative flushing fluid volume were recorded.
RESULTS


The temperature at 5 and 10 min into operation as well as at the end of operation in the two groups was all lower than that before operation and at previous time point ( P <0.01). The temperature at 5 and 10 min after operation in the two groups was all higher than that at previous time point ( P <0.01), but still lower than that before operation ( P <0.01). The temperature at 10 min into operation, at the end of operation, 5 and 10 min after operation in the observation group was higher than that in the control group ( P <0.01,  P <0.05). The total incidence rate of hypothermia in the observation group was 2.0% (3/150), which was significantly lower than 13.3% (20/150) in the control group ( P <0.01). The total incidence rate of shivering was 18.0% (27/150) in the observation group and 28.7% (43/150) in the control group ( P >0.05).
CONCLUSION


The medicated plaster at Dazhui (GV 14) can effectively prevent perioperative hypothermia and improve comfort in patients undergoing PKRP and ureteroscopic laser lithotripsy.",2020,The medicated plaster at Dazhui (GV 14) can effectively prevent perioperative hypothermia and improve comfort in patients undergoing PKRP and ureteroscopic laser lithotripsy.,"['300 patients with ASA gradeⅠorⅡreceiving ureteroscopic laser lithotripsy or PKRP under total intravenous anesthesia (TIVA', 'patients undergoing PKRP and', 'patients undergoing PKRP and ureteroscopic laser lithotripsy', 'patients undergoing plasmakinetic resection of prostate (PKRP) and ureteroscopic laser lithotripsy']","['Medicated plaster at Dazhui (GV 14', 'medicated plaster at Dazhui (GV 14', 'routine heat preservation measures', 'ureteroscopic laser lithotripsy', 'medicated plaster at Dazhui (GV 14) 30 min before operation']","['temperature (ear temperature), mean arterial pressure (MAP), heart rate and blood oxygen saturation (SpO 2 ) at each time point (resting state before operation, 5, 10 min into operation', 'total incidence rate of shivering', 'total incidence rate of hypothermia', 'perioperative hypothermia', 'number of hypothermia, the classification of postoperative shivering degree, operation time, propofol dosage, intraoperative infusion volume and intraoperative flushing fluid volume']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0206099', 'cui_str': 'Laser Lithotripsy'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0473965', 'cui_str': 'Total intravenous anesthesia'}]","[{'cui': 'C0460977', 'cui_str': 'Plasters'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0206099', 'cui_str': 'Laser Lithotripsy'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0013443', 'cui_str': 'Ear structure'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0428174', 'cui_str': 'Hemoglobin saturation with oxygen'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0036973', 'cui_str': 'Shivering or rigors'}, {'cui': 'C0020672', 'cui_str': 'Hypothermia'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C1736186', 'cui_str': 'Postoperative shivering'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0005874', 'cui_str': 'Blushing'}, {'cui': 'C0449971', 'cui_str': 'Volume of fluid used'}]",300.0,0.0127513,The medicated plaster at Dazhui (GV 14) can effectively prevent perioperative hypothermia and improve comfort in patients undergoing PKRP and ureteroscopic laser lithotripsy.,"[{'ForeName': 'Gui-Jie', 'Initials': 'GJ', 'LastName': 'Yu', 'Affiliation': 'Department of Anesthesiology, Shuguang Hospital Affiliated to Shanghai University of TCM, Shanghai 200021, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Shuguang Hospital Affiliated to Shanghai University of TCM, Shanghai 200021, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Song', 'Affiliation': 'Department of Anesthesiology, Shuguang Hospital Affiliated to Shanghai University of TCM, Shanghai 200021, China.'}, {'ForeName': 'Ya-Lan', 'Initials': 'YL', 'LastName': 'Zhou', 'Affiliation': 'Department of Anesthesiology, Shuguang Hospital Affiliated to Shanghai University of TCM, Shanghai 200021, China.'}, {'ForeName': 'Xiao-Hui', 'Initials': 'XH', 'LastName': 'Wu', 'Affiliation': 'Department of Anesthesiology, Shuguang Hospital Affiliated to Shanghai University of TCM, Shanghai 200021, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': 'Department of Anesthesiology, Shuguang Hospital Affiliated to Shanghai University of TCM, Shanghai 200021, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Shuguang Hospital Affiliated to Shanghai University of TCM, Shanghai 200021, China.'}]",Zhongguo zhen jiu = Chinese acupuncture & moxibustion,['10.13703/j.0255-2930.20190915-0001']
1585,33075067,"Anthelminthic treatment receipt and its predictors in Lake Victoria fishing communities, Uganda: Intervention coverage results from the LaVIISWA cluster randomised trial.","BACKGROUND


Mass drug administration (MDA) is a cornerstone of control of parasitic helminths. In schistosomiasis-endemic areas with >50% of school-aged children infected, community-wide MDA with praziquantel is recommended by the World Health Organisation (WHO), with target coverage of >75%. Using data from a cluster-randomised trial of MDA treatment strategies, we aimed to describe the proportion of eligible residents who received MDA and predictors of treatment receipt, and to assess associations with helminth prevalence.
METHODS


In the Koome islands of Lake Victoria, Uganda, where baseline schistosomiasis prevalence (by single stool sample, Kato-Katz) was 52% overall (all ages) and 67% among school-aged children, we conducted a cluster-randomised trial of community-wide, intensive MDA (quarterly single-dose praziquantel 40mg/kg; triple-dose albendazole 400mg) versus standard, Uganda government intervention (annual single-dose praziquantel 40mg/kg; 6-monthly single-dose albendazole). Twenty-six fishing villages were randomised, 13 per trial arm, for four years. At each treatment round, praziquantel treatment and the first dose of albendazole treatment were directly observed by the study team, registers of village residents were updated and the proportion receiving treatment among those eligible recorded.
RESULTS


During the four-year MDA, at each treatment round an average of 13,382 people were registered in the 26 villages (7,153 and 6,229 in standard and intensive intervention villages, respectively). Overall, the proportion of those eligible receiving praziquantel was lower than for albendazole (60% versus 65%), particularly in the standard arm (61% versus 71%) compared to the intensive arm (60% versus 62%). Albendazole receipt was lower when given concurrently with praziquantel. Absence was the commonest reason for non-receipt of treatment (81% albendazole, 77% praziquantel), followed by refusal (14% albendazole, 18% praziquantel). Proportions receiving treatment were lowest among school-aged children, but did not differ by sex. Longitudinal analysis of a subgroup of residents who did not move during the study period found that persistent non-receipt of treatment in this subgroup was rare. Refusal to receive treatment was highest among adults and more common among females.
CONCLUSION


In schistosomiasis high-risk communities, a combination of approaches to increasing treatment coverage, such as extended periods of treatment delivery, and the provision of incentives, may be required to achieve WHO targets.",2020,"Absence was the commonest reason for non-receipt of treatment (81% albendazole, 77% praziquantel), followed by refusal (14% albendazole, 18% praziquantel).","['Twenty-six fishing villages', '13,382 people were registered in the 26 villages (7,153 and 6,229 in standard and intensive intervention villages, respectively']","['MDA', 'Albendazole', 'albendazole, 18% praziquantel', 'albendazole 400mg) versus standard, Uganda government intervention (annual single-dose praziquantel 40mg/kg; 6-monthly single-dose albendazole', 'albendazole', 'praziquantel']",[],"[{'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C4505223', 'cui_str': 'Mass Administration'}, {'cui': 'C0001911', 'cui_str': 'Albendazole'}, {'cui': 'C0032911', 'cui_str': 'Praziquantel'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}, {'cui': 'C0018104', 'cui_str': 'Government'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",[],,0.133095,"Absence was the commonest reason for non-receipt of treatment (81% albendazole, 77% praziquantel), followed by refusal (14% albendazole, 18% praziquantel).","[{'ForeName': 'Hellen', 'Initials': 'H', 'LastName': 'Akurut', 'Affiliation': 'Immunomodulation and Vaccines Programme, MRC/UVRI and LSHTM Uganda Research Unit Entebbe, Uganda.'}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Sanya', 'Affiliation': 'Immunomodulation and Vaccines Programme, MRC/UVRI and LSHTM Uganda Research Unit Entebbe, Uganda.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Lubyayi', 'Affiliation': 'Immunomodulation and Vaccines Programme, MRC/UVRI and LSHTM Uganda Research Unit Entebbe, Uganda.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Nampijja', 'Affiliation': 'Immunomodulation and Vaccines Programme, MRC/UVRI and LSHTM Uganda Research Unit Entebbe, Uganda.'}, {'ForeName': 'Moses', 'Initials': 'M', 'LastName': 'Kizza', 'Affiliation': 'Immunomodulation and Vaccines Programme, MRC/UVRI and LSHTM Uganda Research Unit Entebbe, Uganda.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Kaweesa', 'Affiliation': 'Vector Control Division, Uganda Ministry of Health, Kampala, Uganda.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Kizindo', 'Affiliation': 'Immunomodulation and Vaccines Programme, MRC/UVRI and LSHTM Uganda Research Unit Entebbe, Uganda.'}, {'ForeName': 'Moses', 'Initials': 'M', 'LastName': 'Sewankambo', 'Affiliation': 'Immunomodulation and Vaccines Programme, MRC/UVRI and LSHTM Uganda Research Unit Entebbe, Uganda.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Nsubuga', 'Affiliation': 'Immunomodulation and Vaccines Programme, MRC/UVRI and LSHTM Uganda Research Unit Entebbe, Uganda.'}, {'ForeName': 'Edridah', 'Initials': 'E', 'LastName': 'Tukahebwa', 'Affiliation': 'Vector Control Division, Uganda Ministry of Health, Kampala, Uganda.'}, {'ForeName': 'Narcis B', 'Initials': 'NB', 'LastName': 'Kabatereine', 'Affiliation': 'Vector Control Division, Uganda Ministry of Health, Kampala, Uganda.'}, {'ForeName': 'Alison M', 'Initials': 'AM', 'LastName': 'Elliott', 'Affiliation': 'Immunomodulation and Vaccines Programme, MRC/UVRI and LSHTM Uganda Research Unit Entebbe, Uganda.'}, {'ForeName': 'Emily L', 'Initials': 'EL', 'LastName': 'Webb', 'Affiliation': 'MRC Tropical Epidemiology Group, London School of Hygiene and Tropical Medicine, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",PLoS neglected tropical diseases,['10.1371/journal.pntd.0008718']
1586,33075100,Fitbit wear-time and patterns of activity in cancer survivors throughout a physical activity intervention and follow-up: Exploratory analysis from a randomised controlled trial.,"OBJECTIVE


There has been growing interest in the use of smart wearable technology to promote physical activity (PA) behaviour change. However, little is known concerning PA patterns throughout an intervention or engagement with trackers. The objective of the study was to explore patterns of Fitbit-measured PA and wear-time over 24-weeks and their relationship to changes in Actigraph-derived moderate-to-vigorous PA (MVPA).
METHODS


Twenty-nine intervention participants (88%) from the wearable activity technology and action-planning (WATAAP) trial in colorectal and endometrial cancer survivors accepted a Fitbit friend request from the research team to permit monitoring of Fitbit activity. Daily steps and active minutes were recorded for each participant over the 12-week intervention and throughout the follow-up period to 24-weeks. Accelerometer (GT9X) derived MVPA was assessed at end of intervention (12-weeks) and end of follow-up (24-weeks).
RESULTS


Fitbit wear-time over the 24-weeks of data was remarkably consistent, with median adherence score of 100% for all weeks. During the intervention, participants recorded a median 8006 steps/day. Daily step count was slightly increased through week-13 to week-24 with a median of 8191 steps/day (p = 0.039). Actigraph and Fitbit derived measures were highly correlated but demonstrated poor agreement overall. Fitbit measured activity was closest to MVPA measured using Freedson cut-points as no bias was observed.
CONCLUSIONS


Step count was maintained throughout the trial displaying promise for the effectiveness of smart-wearable interventions to reduce sedentary behaviour beyond the intervention period. Further worthwhile work should compare more advanced smart-wearable technology with accelerometers in order to improve agreement and explore less resource-intensive methods to assess PA that could be scalable.",2020,Daily step count was slightly increased through week-13 to week-24 with a median of 8191 steps/day (p = 0.039).,"['Twenty-nine intervention participants (88%) from the', 'cancer survivors', 'in colorectal and endometrial cancer survivors']","['physical activity intervention', 'wearable activity technology and action-planning (WATAAP) trial']","['median adherence score', 'Daily step count']","[{'cui': 'C0450351', 'cui_str': '29'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C0007103', 'cui_str': 'Endometrial neoplasms malignant'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439157', 'cui_str': 'counts'}]",,0.051742,Daily step count was slightly increased through week-13 to week-24 with a median of 8191 steps/day (p = 0.039).,"[{'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Hardcastle', 'Affiliation': 'School of Health and Human Performance, Dublin City University, Dublin, Ireland.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Jiménez-Castuera', 'Affiliation': 'Faculty of Sport Sciences, University of Extremadura, Cáceres, Spain.'}, {'ForeName': 'Chloé', 'Initials': 'C', 'LastName': 'Maxwell-Smith', 'Affiliation': 'School of Psychology, Curtin University, Bentley, Perth, Western Australia, Australia.'}, {'ForeName': 'Max K', 'Initials': 'MK', 'LastName': 'Bulsara', 'Affiliation': 'Institute for Health Research, University of Notre Dame, Fremantle, Western Australia, Australia.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Hince', 'Affiliation': 'Institute for Health Research, University of Notre Dame, Fremantle, Western Australia, Australia.'}]",PloS one,['10.1371/journal.pone.0240967']
1587,33075131,Comparing Occupational Adaptation-Based and Traditional Training Programs for Dementia Care Teams: An Embedded Mixed-Methods Study.,"BACKGROUND AND OBJECTIVES


With growing demand for a dementia-capable workforce, attention shifts from disseminating knowledge of care strategies to facilitating teams translating knowledge in practice. Occupational Adaptation (OA) is a theoretical framework used to facilitate people resolving real-world challenges through active problem solving, using relative mastery as its measure. This pilot study evaluated if and how OA-based training improves dementia care teams' relative mastery and team development more than a skills-based (SB) program.
RESEARCH DESIGN AND METHODS


We report results of an embedded mixed-methods study with 28 employees of a continuing care retirement community (two groups randomly assigned to nine-week programs). Data collection entailed two surveys conducted pre, mid, and post-intervention; observations; journals; and follow-up interviews. We extended beyond quantitative and qualitative analyses with cross-cutting analyses exploring exemplar and exceptional cases.
RESULTS


The OA group reported significantly greater improvements in relative mastery and team development (p < .05). Qualitative data supported the statistical findings and illuminated processes that led OA to out-perform SB. OA participants, those who analyzed real cases and alternated collaborative planning with cooperative action, were more likely to indicate pre-post differences in relative mastery and team development.
DISCUSSION AND IMPLICATIONS


We identified features of the OA program that diverse participants deemed effective; features that suggest how OA could underpin clinically relevant learning for workers. Further research is required to develop evidence of clinical effectiveness; however, our findings have relevance for agencies wishing to promote knowledge translation and collaborative problem solving in dementia workforce training.",2020,The OA group reported significantly greater improvements in relative mastery and team development (p < .05).,"['Dementia Care Teams', '28 employees of a continuing care retirement community (two groups randomly assigned to nine-week programs']","['Occupational Adaptation-Based and Traditional Training Programs', 'Occupational Adaptation (OA', 'OA-based training']",['relative mastery and team development'],"[{'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C4520469', 'cui_str': 'Continuing care retirement community'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0521127', 'cui_str': 'Occupational'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}]",28.0,0.0522396,The OA group reported significantly greater improvements in relative mastery and team development (p < .05).,"[{'ForeName': 'M Heather', 'Initials': 'MH', 'LastName': 'McKay', 'Affiliation': 'Partnerships for Health, Hillsborough, North Carolina.'}, {'ForeName': 'Noralyn D', 'Initials': 'ND', 'LastName': 'Pickens', 'Affiliation': ""School of Occupational Therapy, Texas Woman's University, Dallas, Texas.""}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Medley', 'Affiliation': ""School of Physical Therapy, Texas Woman's University, Denton, Texas.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cooper', 'Affiliation': 'School of Education, Elon University, Elon, North Carolina.'}, {'ForeName': 'Cynthia L', 'Initials': 'CL', 'LastName': 'Evetts', 'Affiliation': ""School of Occupational Therapy, Texas Woman's University, Dallas, Texas.""}]",The Gerontologist,['10.1093/geront/gnaa160']
1588,33075157,Cost-effectiveness of a telehealth intervention for in-home dementia care support: Findings from the FamTechCare clinical trial.,"Determining the cost-effectiveness of technological interventions is a crucial aspect in assuring these interventions can be adopted. The FamTechCare intervention is an innovative telehealth support that links family caregivers of persons living with dementia to tailored feedback from dementia care experts based on caregiver-initiated video recordings of challenging care situations. The FamTechCare intervention has demonstrated significant reductions in caregiver depression and increases in caregiver competence when compared to standard telephone support. The purpose of this article is to report on the cost-effectiveness of the FamTechCare telehealth intervention. Process-based costing and a cost-effectiveness analysis using the incremental cost-effectiveness ratio (ICER) was completed with 68 caregiver and person living dementia with dyads. The cost of the 12-week FamTechCare telehealth intervention was found to be greater ($48.43 per dyad per week) due to the telehealth equipment, recording application, and expert panel time compared with the telephone support intervention ($6.96 per dyad per week). The ICER was $18.51 for caregiver depression and $36.31 for caregiver competence indicating that it cost no more than $36.38 per dyad per week over 12 weeks to achieve significant improvement in depression and competence in the FamTechCare caregivers compared to the telephone support caregivers. The FamTechCare intervention appears to be cost-effective when compared to the telephone support intervention and remains near the willingness-to-pay threshold for caregivers providing in-home dementia care support.",2020,The FamTechCare intervention has demonstrated significant reductions in caregiver depression and increases in caregiver competence when compared to standard telephone support.,['68 caregiver and person living dementia with dyads'],"['telephone support intervention', 'FamTechCare intervention', 'technological interventions', 'telehealth intervention', 'FamTechCare telehealth intervention']","['depression and competence', 'incremental cost-effectiveness ratio (ICER', 'caregiver depression', 'caregiver competence', 'Cost-effectiveness', 'ICER']","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}]",,0.0188988,The FamTechCare intervention has demonstrated significant reductions in caregiver depression and increases in caregiver competence when compared to standard telephone support.,"[{'ForeName': 'Clarissa A', 'Initials': 'CA', 'LastName': 'Shaw', 'Affiliation': 'College of Nursing, University of Iowa, Iowa City, Iowa, USA.'}, {'ForeName': 'Kristine N', 'Initials': 'KN', 'LastName': 'Williams', 'Affiliation': 'School of Nursing, University of Kansas, Kansas City, Kansas, USA.'}, {'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Lee', 'Affiliation': 'Kansas Medical Center, University of Kansas, Kansas City, Kansas, USA.'}, {'ForeName': 'Carissa K', 'Initials': 'CK', 'LastName': 'Coleman', 'Affiliation': 'School of Nursing, University of Kansas, Kansas City, Kansas, USA.'}]",Research in nursing & health,['10.1002/nur.22076']
1589,33075159,Drug treatments for managing cystic fibrosis-related diabetes.,"BACKGROUND


The Cystic Fibrosis Foundation recommends both short-term and long-acting insulin therapy when cystic fibrosis-related diabetes (CFRD) has been diagnosed. Diagnosis is based on: an elevated fasting blood glucose level greater than 6.94 mmol/L (125 mg/dL); or oral glucose tolerance tests greater than 11.11 mmol/L (200 mg/dL) at two hours; or symptomatic diabetes for random glucose levels greater than 11.11 mmol/L (200 mg/dL); or glycated hemoglobin levels of at least 6.5%. This is an update of a previously published review.
OBJECTIVES


To establish the effectiveness of insulin and oral agents for managing diabetes in people with cystic fibrosis in relation to blood sugar levels, lung function and weight management.
SEARCH METHODS


We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Trials Register comprising references identified from comprehensive electronic database searches and handsearches of relevant journals and abstract books of conference proceedings. We also handsearched abstracts from pulmonary symposia and the North American Cystic Fibrosis Conferences. Date of most recent register search: 10 September 2020. We searched online trials registries; date of most recent searches: 21 March 2020.
SELECTION CRITERIA


Randomized controlled trials comparing all methods of pharmacological diabetes therapy in people with diagnosed CFRD.
DATA COLLECTION AND ANALYSIS


Two authors independently extracted data and assessed the risk of bias in the included studies. Authors also used GRADE to assess the quality of the evidence.
MAIN RESULTS


The searches identified 29 trials (45 references). Four included trials provide results: one short-term single-center cross-over trial (seven adults) comparing insulin with oral repaglinide and no medication in adults with CFRD and normal fasting glucose; one long-term multicenter trial (61 adults with CFRD) comparing insulin with oral repaglinide and placebo; one long-term multicenter trial (67 adults) comparing insulin with oral repaglinide; and one 12-week single-center cross-over trial (20 adults) comparing the long-acting insulin glargine to short-term neutral protamine Hagedorn insulin. Two ongoing trials of newly approved incretin mimics have been noted for possible future inclusion. Downgrading of the quality of the evidence was mainly due to risks of bias across all domains, but particularly due to concerns surrounding allocation concealment and selective reporting. There were also some concerns due to imprecision from small sample sizes and low event rates. Finally, there may be some bias due to the amounts of insulin and repaglinide given not being comparable. Data from one trial comparing insulin to placebo (39 participants) did not show any difference between groups for the primary outcomes of blood glucose levels (very low-quality evidence), lung function (low-quality evidence) or nutritional status (low-quality evidence). Similarly, no differences between groups were seen for the secondary outcomes of number of hypoglycemic episodes (low-quality evidence), secondary infection complications or quality of life (QoL). These results were mirrored in the narrative reports for the second trial in this comparison (seven participants). Data from the one-year trial comparing repaglinide to placebo (38 participants), showed no differences between groups for the primary outcomes of blood glucose levels (very low-quality evidence), lung function (low-quality evidence) and nutritional status (low-quality evidence). Also, no differences were seen between groups for the secondary outcomes of number of hypoglycemic episodes (low-quality evidence), secondary infection complications or QoL. These findings were mirrored in the narrative reports for the second trial (n = 7) in this comparison. Three trials compared insulin to repaglinide (119 participants). Data from one trial (n = 67) showed no difference in blood glucose levels at either 12 months (high-quality evidence) or 24 months; narrative reports from one trial (45 participants) reported no difference between groups, but the second trial (7 participants) reported a beneficial effect of insulin over repaglinide. Two trials (112 participants) found no difference between insulin and repaglinide in lung function or nutritional status (moderate-quality evidence). Two trials (56 participants) reported no difference in the number of hypoglycemic episodes (low-quality evidence). One trial (45 participants) reported no difference between groups in secondary infections and cystic fibrosis QoL. The single trial comparing glargine to neutral protamine Hagedorn insulin did not report directly on the review's primary outcomes, but did report no differences between groups in post-prandial glucose values and weight; neither group reported infectious complications. There was no difference in episodes of hypoglycemia (very low-quality evidence) and while there was no difference reported in QoL, all participants opted to continue treatment with glargine after the trial was completed. Mortality was not reported by any trial in any comparison, but death was not given as a reason for withdrawal in any trial.
AUTHORS' CONCLUSIONS


This review has not found any conclusive evidence that any agent has a distinct advantage over another in controlling hyperglycemia or the clinical outcomes associated with CFRD. Given the treatment burden already experienced by people with cystic fibrosis, oral therapy may be a viable treatment option. While some cystic fibrosis centers use oral medications to help control diabetes, the Cystic Fibrosis Foundation (USA) clinical practice guidelines support the use of insulin therapy and this remains the most widely-used treatment method. Randomized controlled trials specifically related to controlling diabetes and its impact on the course of pulmonary disease process in cystic fibrosis continue to be a high priority. Specifically, investigators should evaluate adherence to different therapies and also whether there is benefit in using additional hypoglycemic agents as well as the newly approved incretin mimics. Agents that potentiate insulin action, especially agents with additional anti-inflammatory potential should also be further investigated as adjuvant therapy to insulin.",2020,"Data from one trial comparing insulin to placebo (39 participants) did not show any difference between groups for the primary outcomes of blood glucose levels (very low-quality evidence), lung function (low-quality evidence) or nutritional status (low-quality evidence).","['people with diagnosed CFRD', '119 participants', 'in adults with CFRD and normal fasting glucose; one long-term multicenter trial (61 adults with CFRD) comparing', 'people with cystic fibrosis', 'managing cystic fibrosis-related diabetes', 'cystic fibrosis-related diabetes (CFRD']","['glargine', 'insulin and oral agents', 'insulin with oral repaglinide', 'pharmacological diabetes therapy', 'repaglinide', 'insulin with oral repaglinide and no medication', 'insulin with oral repaglinide and placebo', 'placebo', 'insulin and repaglinide', 'long-acting insulin glargine to short-term neutral protamine Hagedorn insulin', 'repaglinide to placebo']","['blood glucose levels (very low-quality evidence), lung function (low-quality evidence) and nutritional status (low-quality evidence', 'infectious complications', 'Mortality', 'number of hypoglycemic episodes (low-quality evidence), secondary infection complications or QoL', 'glycated hemoglobin levels', 'episodes of hypoglycemia', 'blood glucose levels', 'elevated fasting blood glucose level', 'blood glucose levels (very low-quality evidence), lung function (low-quality evidence) or nutritional status (low-quality evidence', 'beneficial effect of insulin over repaglinide', 'lung function or nutritional status (moderate-quality evidence', 'number of hypoglycemic episodes (low-quality evidence', 'secondary infections and cystic fibrosis QoL', 'oral glucose tolerance tests', 'number of hypoglycemic episodes (low-quality evidence), secondary infection complications or quality of life (QoL']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C2242728', 'cui_str': 'Cystic fibrosis related diabetes'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0206012', 'cui_str': 'Multicentre Trials'}, {'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}]","[{'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0246689', 'cui_str': 'repaglinide'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0304870', 'cui_str': 'Long-acting insulin'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0021658', 'cui_str': 'insulin, isophane'}]","[{'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0442811', 'cui_str': 'Very low'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0745153', 'cui_str': 'Hypoglycaemic episode'}, {'cui': 'C0442886', 'cui_str': 'Secondary infection'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0246689', 'cui_str': 'repaglinide'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}]",61.0,0.164958,"Data from one trial comparing insulin to placebo (39 participants) did not show any difference between groups for the primary outcomes of blood glucose levels (very low-quality evidence), lung function (low-quality evidence) or nutritional status (low-quality evidence).","[{'ForeName': 'Gary M', 'Initials': 'GM', 'LastName': 'Onady', 'Affiliation': 'Boonshoft School of Medicine, Wright State University, Dayton, Ohio, USA.'}, {'ForeName': 'Adrienne', 'Initials': 'A', 'LastName': 'Stolfi', 'Affiliation': ""Department of Pediatrics, Children's Medical Center, Dayton, Ohio, USA.""}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD004730.pub5']
1590,33075197,Sinecatechins ointment as a potential novel treatment for usual type vulval intraepithelial neoplasia: a single center double-blind randomised control study.,"OBJECTIVE


To compare the safety and efficacy of 10% sinecatechins (Veregen®) ointment against placebo in the treatment of usual type vulvar intraepithelial neoplasia (uVIN).
DESIGN


A Phase II double-blind randomised control trial.
SETTING


A tertiary gynaecological oncology referral center.
POPULATION


All women diagnosed with primary and recurrent uVIN.
METHODS


Eligible patients were randomised 1:1 to receive either sinecatechins or placebo ointment (applied 3 times daily for 16 weeks), and were followed up at 2, 4, 8, 16, 32 and 52 weeks.
MAIN OUTCOME MEASURES


The primary outcome measure, recorded at 16 and 32 weeks, was histological response (HR). Secondary outcome measures included clinical (CR) response, toxicity, quality of life and pain scores.
RESULTS


There was no observed difference in HR between the two arms. However, of the 26 patients who were randomised, all 13 patients who received sinecatechins showed either complete (n=5) or partial (n=8) CR, when best CR was evaluated. In placebo group, 3 patients had complete CR, 2 had partial CR, 6 had stable disease and 2 were lost to follow up. Patients in the sinecatechins group showed a statistically significant improvement in best observed CR as compared to the placebo group (P=0.002). There was no difference in toxicity reported in both groups.
CONCLUSION


Although we did not observe a difference in HR between the two treatment arms, we found that 10% sinecatechins application is safe and shows promise in inducing clinical resolution of uVIN lesions and symptom improvement, thus warranting further investigation in a larger multicentre study.",2020,Patients in the sinecatechins group showed a statistically significant improvement in best observed CR as compared to the placebo group (P=0.002).,"['usual type vulval intraepithelial neoplasia', 'Eligible patients', '26 patients who were randomised, all 13 patients who received sinecatechins showed either complete (n=5) or partial (n=8) CR', 'usual type vulvar intraepithelial neoplasia (uVIN', 'All women diagnosed with primary and recurrent uVIN', 'A tertiary gynaecological oncology referral center']","['10% sinecatechins (Veregen®) ointment against placebo', 'placebo', 'Sinecatechins ointment', 'sinecatechins or placebo ointment']","['HR', 'safety and efficacy', 'histological response (HR', 'clinical (CR) response, toxicity, quality of life and pain scores', 'CR', 'toxicity']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0346210', 'cui_str': 'Dysplasia of vulva'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1960121', 'cui_str': 'Sinecatechins'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0495107', 'cui_str': 'Vulval intraepithelial neoplasia grade 2'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C1321164', 'cui_str': 'Gynecological oncology'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C1960121', 'cui_str': 'Sinecatechins'}, {'cui': 'C1816306', 'cui_str': 'Veregen'}, {'cui': 'C0028912', 'cui_str': 'Ointment'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",,0.68127,Patients in the sinecatechins group showed a statistically significant improvement in best observed CR as compared to the placebo group (P=0.002).,"[{'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Yap', 'Affiliation': 'Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Edgbaston, B15 2TT, United Kingdom.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Slade', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, University of Birmingham, Edgbaston, B15 2TT, United Kingdom.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'Goddard', 'Affiliation': 'Pan Birmingham Gynaecological Cancer Centre, City Hospital, Birmingham, B18 7QH, United Kingdom.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Dawson', 'Affiliation': 'Department of Microbiology & Infection, Warwick Medical School, University of Warwick, Coventry, CV4 7AL, England.'}, {'ForeName': 'Raji', 'Initials': 'R', 'LastName': 'Ganesan', 'Affiliation': ""Department of Histopathology, Birmingham Women's NHS Foundation Trust, Mindelsohn Way, Edgbaston, Birmingham, B15 2TG, UK.""}, {'ForeName': 'Shireen', 'Initials': 'S', 'LastName': 'Velangi', 'Affiliation': 'Department of Dermatology, Queen Elizabeth Hospital, Mindelsohn Way, Edgbaston, Birmingham, B15 2GW.'}, {'ForeName': 'Banchhita', 'Initials': 'B', 'LastName': 'Sahu', 'Affiliation': 'Department of Obstetrics and Gynaecology, The Shrewsbury and Telford Hospital NHS Trust. Mytton Oak Rd, Shrewsbury SY3 8XQ.'}, {'ForeName': 'Baljit', 'Initials': 'B', 'LastName': 'Kaur', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, University of Birmingham, Edgbaston, B15 2TT, United Kingdom.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Hughes', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, University of Birmingham, Edgbaston, B15 2TT, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Luesley', 'Affiliation': 'Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Edgbaston, B15 2TT, United Kingdom.'}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16574']
1591,33075257,"In adults with severe acute GI bleeding, tranexamic acid did not reduce death due to bleeding at 5 days.","SOURCE CITATION


The HALT-IT Trial Collaborators.  Effects of a high-dose 24-h infusion of tranexamic acid on death and thromboembolic events in patients with acute gastrointestinal bleeding (HALT-IT): an international randomised, double-blind, placebo-controlled trial.  Lancet. 2020;395:1927-36. 32563378.",2020,"Effects of a high-dose 24-h infusion of tranexamic acid on death and thromboembolic events in patients with acute gastrointestinal bleeding (HALT-IT): an international randomised, double-blind, placebo-controlled trial.  ","['patients with acute gastrointestinal bleeding (HALT-IT', 'adults with severe acute GI bleeding']","['placebo', 'tranexamic acid']",['death and thromboembolic events'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0266807', 'cui_str': 'Acute gastrointestinal hemorrhage'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}]",,0.56969,"Effects of a high-dose 24-h infusion of tranexamic acid on death and thromboembolic events in patients with acute gastrointestinal bleeding (HALT-IT): an international randomised, double-blind, placebo-controlled trial.  ","[{'ForeName': 'Laura C', 'Initials': 'LC', 'LastName': 'Horton', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts, USA (L.C.H.).""}, {'ForeName': 'Joseph D', 'Initials': 'JD', 'LastName': 'Feuerstein', 'Affiliation': 'Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA (J.D.F.).'}]",Annals of internal medicine,['10.7326/ACPJ202010200-046']
1592,33075259,"In adults exposed to COVID-19, hydroxychloroquine did not reduce confirmed or probable COVID-19; trial stopped for futility.","SOURCE CITATION


Boulware DR, Pullen MF, Bangdiwala AS, et al.  A randomized trial of hydroxychloroquine as postexposure prophylaxis for COVID-19.  N Engl J Med. 2020;383:517-25. 32492293.",2020,A randomized trial of hydroxychloroquine as postexposure prophylaxis for COVID-19.  ,[],"['COVID-19, hydroxychloroquine', 'hydroxychloroquine']",[],[],"[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}]",[],,0.0523778,A randomized trial of hydroxychloroquine as postexposure prophylaxis for COVID-19.  ,"[{'ForeName': 'Ameeta', 'Initials': 'A', 'LastName': 'Singh', 'Affiliation': 'University of Alberta, Edmonton, Alberta, Canada (A.S., A.S.).'}, {'ForeName': 'Ashlesha', 'Initials': 'A', 'LastName': 'Sonpar', 'Affiliation': 'University of Alberta, Edmonton, Alberta, Canada (A.S., A.S.).'}]",Annals of internal medicine,['10.7326/ACPJ202010200-041']
1593,33075261,"In ACS treated with drug-eluting stents and 3 mo of DAPT, ticagrelor monotherapy reduced clinical events at 1 y vs. DAPT.","SOURCE CITATION


Kim BK, Hong SJ, Cho YH, et al.  Effect of ticagrelor monotherapy vs ticagrelor with aspirin on major bleeding and cardiovascular events in patients with acute coronary syndrome: the TICO randomized clinical trial.  JAMA. 2020;323:2407-16. 32543684.",2020,Effect of ticagrelor monotherapy vs ticagrelor with aspirin on major bleeding and cardiovascular events in patients with acute coronary syndrome,['patients with acute coronary syndrome'],"['DAPT, ticagrelor monotherapy', 'ticagrelor monotherapy vs ticagrelor with aspirin']","['major bleeding and cardiovascular events', 'clinical events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}]","[{'cui': 'C0634829', 'cui_str': '1,2-dilinolenoyl-3-(4-aminobutyryl)propane-1,2,3-triol'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",,0.0193733,Effect of ticagrelor monotherapy vs ticagrelor with aspirin on major bleeding and cardiovascular events in patients with acute coronary syndrome,"[{'ForeName': 'Chirag', 'Initials': 'C', 'LastName': 'Bavishi', 'Affiliation': 'Lifespan Cardiovascular Institute, Warren Alpert Medical School of Brown University, Providence, Rhode Island, USA (C.B.).'}]",Annals of internal medicine,['10.7326/ACPJ202010200-043']
1594,33075263,"In adults with chest pain, a troponin limit of detection strategy did not increase early discharge rate.","SOURCE CITATION


Carlton EW, Ingram J, Taylor H, et al.  Limit of detection of troponin discharge strategy versus usual care: randomised controlled trial.  Heart. 2020. [Epub ahead of print.] 32371401.",2020,"SOURCE CITATION


Carlton EW, Ingram J, Taylor H, et al.  ",['adults with chest pain'],['troponin discharge strategy'],['discharge rate'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008031', 'cui_str': 'Chest pain'}]","[{'cui': 'C0041199', 'cui_str': 'Troponin'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}]","[{'cui': 'C0012621', 'cui_str': 'Discharge'}]",,0.0874098,"SOURCE CITATION


Carlton EW, Ingram J, Taylor H, et al.  ","[{'ForeName': 'James', 'Initials': 'J', 'LastName': 'Brophy', 'Affiliation': 'McGill University Health Center, Montreal, Quebec, Canada (J.B.).'}]",Annals of internal medicine,['10.7326/ACPJ202010200-045']
1595,33075332,A randomized controlled trial of methylergonovine prophylaxis after dilation and evacuation abortion.,"OBJECTIVE


To evaluate the efficacy of intramuscular methylergonovine maleate as prophylaxis against excessive bleeding when given after dilation and evacuation (D&E) at 20 to 24 weeks.
STUDY DESIGN


We performed a randomized, double-blinded, placebo-controlled trial in patients without excessive bleeding requiring intervention after D&E completion. We administered study treatment within one minute of the end of the procedure. We primarily compared outcomes using a composite of indicators of excessive post-procedure blood loss (post-procedure measured blood loss exceeding 125 mL, uterine massage or compression for at least two minutes, administration of additional uterotonic medication, intrauterine balloon tamponade, uterine re-aspiration, blood transfusion, uterine artery embolization, hospital admission for bleeding, or major surgery). Secondary outcomes included individual indicator occurrences, satisfaction, and side effects.
RESULTS


From March 3, 2015 to March 31, 2017, we randomized 284 participants (n=140 methylergonovine, n=144 placebo), five before we registered the trial with clinicaltrials.gov. Baseline characteristics were similar between groups. The composite outcome occurred in 78 (56%) methylergonovine and 75 (52%) placebo participants (p=0.5). Methylergonovine recipients required more intrauterine balloon use (n=20 [14%]) versus placebo (n=10 [7%]), p=0.04. We also observed a non-significant trend towards more uterotonic administration (n=56 [40%] versus n=43 [30%], p=0.07) and hospital admissions for bleeding (n=4 [3%] versus n=0, p=0.06) in the methylergonovine group compared to placebo.
CONCLUSION


We observed no improvement in the composite outcome for excessive bleeding with prophylactic post-procedure methylergonovine. In addition, individual excessive bleeding outcomes occurred more frequently in the methylergonovine group, potentially indicating harm with its prophylactic use after D&E.",2020,"Methylergonovine recipients required more intrauterine balloon use (n=20 [14%]) versus placebo (n=10 [7%]), p=0.04.","['284 participants (n=140', 'patients without excessive bleeding requiring intervention after D&E completion']","['methylergonovine', 'uterine massage or compression for at least two minutes, administration of additional uterotonic medication, intrauterine balloon tamponade, uterine re-aspiration, blood transfusion, uterine artery embolization, hospital admission for bleeding, or major surgery', 'methylergonovine maleate', 'methylergonovine prophylaxis', 'placebo', 'methylergonovine, n=144 placebo', 'Methylergonovine']","['individual indicator occurrences, satisfaction, and side effects', 'hospital admissions for bleeding', 'intrauterine balloon use', 'individual excessive bleeding outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442802', 'cui_str': 'Excessive'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C1282573', 'cui_str': 'Evacuation procedure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0025760', 'cui_str': 'Methylergonovine'}, {'cui': 'C0404386', 'cui_str': 'Uterine massage'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C3653843', 'cui_str': 'UTEROTONICS'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0181374', 'cui_str': 'Intrauterine balloon'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0004056', 'cui_str': 'Aspiration, Psychology'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0729536', 'cui_str': 'Embolization of uterine artery'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0289432', 'cui_str': 'Methylergonovine maleate'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0181374', 'cui_str': 'Intrauterine balloon'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0442802', 'cui_str': 'Excessive'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",284.0,0.773533,"Methylergonovine recipients required more intrauterine balloon use (n=20 [14%]) versus placebo (n=10 [7%]), p=0.04.","[{'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Kerns', 'Affiliation': 'University of California, San Francisco, Department of Obstetrics, Gynecology and Reproductive Sciences, Zuckerberg San Francisco General, 1001 Potrero Avenue, Ward 6D, San Francisco, CA 94110, USA. Electronic address: Jennifer.kerns@ucsf.edu.'}, {'ForeName': 'Geffan', 'Initials': 'G', 'LastName': 'Pearlson', 'Affiliation': 'University of California, San Francisco, Department of Obstetrics, Gynecology and Reproductive Sciences, Zuckerberg San Francisco General, 1001 Potrero Avenue, Ward 6D, San Francisco, CA 94110, USA.'}, {'ForeName': 'Biftu', 'Initials': 'B', 'LastName': 'Mengesha', 'Affiliation': 'University of California, San Francisco, Department of Obstetrics, Gynecology and Reproductive Sciences, Zuckerberg San Francisco General, 1001 Potrero Avenue, Ward 6D, San Francisco, CA 94110, USA.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Harter', 'Affiliation': 'University of California, San Francisco, School of Pharmacy; Zuckerberg San Francisco General; 1001 Potrero Avenue, Ward 6D, San Francisco, CA 94110, USA.'}, {'ForeName': 'Rebecca A', 'Initials': 'RA', 'LastName': 'Jackson', 'Affiliation': 'University of California, San Francisco, Department of Obstetrics, Gynecology and Reproductive Sciences, Zuckerberg San Francisco General, 1001 Potrero Avenue, Ward 6D, San Francisco, CA 94110, USA.'}, {'ForeName': 'Eleanor A', 'Initials': 'EA', 'LastName': 'Drey', 'Affiliation': 'University of California, San Francisco, Department of Obstetrics, Gynecology and Reproductive Sciences, Zuckerberg San Francisco General, 1001 Potrero Avenue, Ward 6D, San Francisco, CA 94110, USA.'}]",Contraception,['10.1016/j.contraception.2020.10.009']
1596,33075376,Association Between Anticoagulation and Survival in Interstitial Lung Disease: An Analysis of the Pulmonary Fibrosis Foundation (PFF) Registry.,"BACKGROUND


Aberrations in the coagulation system have been implicated in the pathogenesis of interstitial lung disease (ILD). Anticoagulants have been proposed as a potential therapy in ILD; however, a randomized control trial examining warfarin as a treatment for IPF was terminated early for harm. This has led some to speculate that warfarin specifically may be harmful in ILD, and use of direct oral anticoagulants (DOACs) may result in superior outcomes.
RESEARCH QUESTION


We sought to delineate the relationship between anticoagulation and outcomes in patients with ILD through an analysis of the Pulmonary Fibrosis Foundation (PFF) registry.
STUDY DESIGN


and Methods: An analysis of all patients in the PFF registry was performed. Patients were stratified into three groups: no anticoagulation (AC), DOAC use, or warfarin use. Survival was analyzed using both Kaplan Meier curves and Cox proportional hazards models.
RESULTS


Of 1,911 patients included in the analysis, 174 (9.1%) were anticoagulated, 93 (4.9%) with DOACs, and 81 (4.2%) with warfarin. There was a two-fold increased risk of death or transplant for patients receiving DOACS, while for warfarin this was over a two and half times greater risk. DOACs were not associated with an increased risk of mortality after adjustment for confounding variables. However, even after adjustment, patients anticoagulated with warfarin remained at increased risk of mortality. In patients with IPF, warfarin was associated with reduced transplant free survival, but DOACs were not. There was no statistically significant difference in survival between those receiving warfarin and those receiving a DOAC.
INTERPRETATION


The need for anticoagulation is associated with an increased risk for death or transplant in patients with ILD, in both the IPF and non-IPF population. Further research is required to determine if warfarin and DOACs present varying safety profiles in ILD patients. (292 words).",2020,"The need for anticoagulation is associated with an increased risk for death or transplant in patients with ILD, in both the IPF and non-IPF population.","['and Methods', '1,911 patients included in the analysis', 'ILD patients', 'Interstitial Lung Disease', 'patients with ILD through an analysis of the Pulmonary Fibrosis Foundation (PFF) registry']","['warfarin', 'no anticoagulation (AC), DOAC use, or warfarin use']","['risk of death or transplant', 'risk of mortality', 'reduced transplant free survival', 'Survival', 'survival']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0206062', 'cui_str': 'Interstitial lung disease'}, {'cui': 'C0034069', 'cui_str': 'Fibrosis of lung'}, {'cui': 'C0016617', 'cui_str': 'Foundations'}, {'cui': 'C0034975', 'cui_str': 'Registries'}]","[{'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",1911.0,0.0847699,"The need for anticoagulation is associated with an increased risk for death or transplant in patients with ILD, in both the IPF and non-IPF population.","[{'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'King', 'Affiliation': 'Inova Fairfax Hospital Advanced Lung Disease and Transplant Clinic. Electronic address: Christopher.king@inova.org.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Freiheit', 'Affiliation': 'University of Michigan School of Public Health, Department of Biostatistics.'}, {'ForeName': 'A Whitney', 'Initials': 'AW', 'LastName': 'Brown', 'Affiliation': 'Inova Fairfax Hospital Advanced Lung Disease and Transplant Clinic.'}, {'ForeName': 'Oksana A', 'Initials': 'OA', 'LastName': 'Shlobin', 'Affiliation': 'Inova Fairfax Hospital Advanced Lung Disease and Transplant Clinic.'}, {'ForeName': 'Shambhu', 'Initials': 'S', 'LastName': 'Aryal', 'Affiliation': 'Inova Fairfax Hospital Advanced Lung Disease and Transplant Clinic.'}, {'ForeName': 'Kareem', 'Initials': 'K', 'LastName': 'Ahmad', 'Affiliation': 'Inova Fairfax Hospital Advanced Lung Disease and Transplant Clinic.'}, {'ForeName': 'Vikramjit', 'Initials': 'V', 'LastName': 'Khangoora', 'Affiliation': 'Inova Fairfax Hospital Advanced Lung Disease and Transplant Clinic.'}, {'ForeName': 'Kevin R', 'Initials': 'KR', 'LastName': 'Flaherty', 'Affiliation': 'University Of Michigan Division of Pulmonary & Critical Care Medicine.'}, {'ForeName': 'Drew', 'Initials': 'D', 'LastName': 'Venuto', 'Affiliation': 'Inova Fairfax Hospital Advanced Lung Disease and Transplant Clinic.'}, {'ForeName': 'Steven D', 'Initials': 'SD', 'LastName': 'Nathan', 'Affiliation': 'Inova Fairfax Hospital Advanced Lung Disease and Transplant Clinic.'}]",Chest,['10.1016/j.chest.2020.10.019']
1597,33075444,Fostering infant food texture acceptance: A pilot intervention promoting food texture introduction between 8 and 15 months.,"Healthy infant feeding practices form the basis of healthy eating behaviour later in life. The effect of providing parents with recommendations on textured food introduction between 8 and 15 months on children's experience with and acceptance of textured foods was studied. Sixty parent/child dyads were randomly assigned to a control group (CG) receiving current French recommendations and an intervention group (IG) receiving a brochure with supplementary advice, tips and monthly counselling on food texture introduction. After the intervention, parents completed self-report measures about the introduction of 188 food items, including purees, soft/small pieces, hard/large pieces and double textures. Children's acceptance of eight textured foods was assessed in a laboratory setting. Parents in the IG introduced more soft/small food pieces (P = 0.004) but not more complex textures (P = 0.15). There was no group difference in children acceptance for any of the textured foods offered in the laboratory. Independent of their study group, children's exposure to texture was associated with birth order, self-feeding with fingers, low gagging frequency and seldom use of commercial baby foods. Higher acceptance was associated with higher exposure to food pieces but not to pureed foods (either smooth or rough) and with children's eating behavioural traits (high food enjoyment, high food responsiveness and low food fussiness). This pilot intervention demonstrated that providing information can be effective in promoting the introduction of small and soft food pieces, but the most effective way to influence the introduction of more challenging textures (hard pieces and double texture) is uncertain. Further research should focus on the identification of barriers to complex texture introduction and on how building on this knowledge for a population-based public health intervention.",2020,Parents in the IG introduced more soft/small food pieces (P = 0.004) but not more complex textures (P = 0.15).,"['Healthy infant feeding practices form the basis of healthy eating behaviour later in life', 'Sixty parent/child dyads']","['control group (CG) receiving current French recommendations and an intervention group (IG) receiving a brochure with supplementary advice, tips and monthly counselling on food texture introduction']","['soft/small food pieces', 'children acceptance']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0376246', 'cui_str': 'French language'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0339897', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0449582', 'cui_str': 'With texture'}]","[{'cui': 'C0205358', 'cui_str': 'Soft'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}]",,0.0391997,Parents in the IG introduced more soft/small food pieces (P = 0.004) but not more complex textures (P = 0.15).,"[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Tournier', 'Affiliation': ""Centre des Sciences du Goût et de L'Alimentation, AgroSup Dijon, CNRS, INRAE, Université Bourgogne Franche-Comté, F-21000, Dijon, France. Electronic address: carole.tournier@inrae.fr.""}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Bernad', 'Affiliation': ""Centre des Sciences du Goût et de L'Alimentation, AgroSup Dijon, CNRS, INRAE, Université Bourgogne Franche-Comté, F-21000, Dijon, France.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Madrelle', 'Affiliation': ""Centre des Sciences du Goût et de L'Alimentation, AgroSup Dijon, CNRS, INRAE, Université Bourgogne Franche-Comté, F-21000, Dijon, France.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Delarue', 'Affiliation': 'Universite Paris-Saclay, INRAE, AgroParisTech, UMR SayFood, F-91300, Massy, France.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Cuvelier', 'Affiliation': 'Universite Paris-Saclay, INRAE, AgroParisTech, UMR SayFood, F-91300, Massy, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Schwartz', 'Affiliation': ""Centre des Sciences du Goût et de L'Alimentation, AgroSup Dijon, CNRS, INRAE, Université Bourgogne Franche-Comté, F-21000, Dijon, France.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Nicklaus', 'Affiliation': ""Centre des Sciences du Goût et de L'Alimentation, AgroSup Dijon, CNRS, INRAE, Université Bourgogne Franche-Comté, F-21000, Dijon, France.""}]",Appetite,['10.1016/j.appet.2020.104989']
1598,33075592,Quantifying regional variations in components of acute stroke unit (ASU) care in the international HeadPoST study.,"OBJECTIVE


Access to acute stroke unit (ASU) care is known to vary worldwide. We aimed to quantify regional variations in the various components of ASU care.
METHOD


Secondary analysis of the Head Positioning in acute Stroke Trial (HeadPoST), an international, multicentre, cluster crossover trial of head-up versus head-down positioning in 11,093 acute stroke patients at 114 hospitals in 9 countries. Patients characteristics and 11 standard components of processes of care were described according to ASU admission within and across four economically-defined regional groups (Australia/UK, China [includes Taiwan], India/Sri Lanka, and South America [Brazil/Chile/Colombia]). Variations in process of ASU care estimates were obtained in hierarchical mixed models, with adjustment for study design and potential patient- and hospital-level confounders.
RESULTS


Of 11,086 patients included in analyses, 59.7% (n = 6620) had an ASU admission. In China, India/Sri Lanka and South America, ASU patients were older, had greater neurological severity and more premorbid conditions than non-ASU patients. ASU patients were more likely to receive reperfusion therapy and multidisciplinary care within regions, but the components of care varied across regions. With Australia/UK as reference, patients in other regions had a lower probability of receiving reperfusion therapy, especially in India/Sri Lanka (adjusted odds ratio [aOR] 0.27, 95% confidence interval [CI] 0.12-0.63) and multidisciplinary care (mainly in formal dysphagia assessment, physiotherapy and occupational therapy).
CONCLUSION


There is significant variation in the components of stroke care across economically-defined regions of the world. Ongoing efforts are required to reduce disparities and optimise health outcomes, especially in resource poor areas.
CLINICAL TRIAL REGISTRATION


HeadPoST is registered at ClinicalTrials.gov (NCT02162017).",2020,"With Australia/UK as reference, patients in other regions had a lower probability of receiving reperfusion therapy, especially in India/Sri Lanka (adjusted odds ratio [aOR] 0.27, 95% confidence interval [CI] 0.12-0.63) and multidisciplinary care (mainly in formal dysphagia assessment, physiotherapy and occupational therapy).
","['Patients characteristics and 11 standard components of processes of care were described according to ASU admission within and across four economically-defined regional groups (Australia/UK, China [includes Taiwan], India/Sri Lanka, and South America', 'Secondary analysis of the Head Positioning in acute Stroke Trial ', '11,093 acute stroke patients at 114 hospitals in 9 countries', 'Of 11,086 patients included in analyses, 59.7% (n\xa0=\xa06620) had an ASU admission']","['HeadPoST', 'head-up versus head-down positioning']",['probability of receiving reperfusion therapy'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0751956', 'cui_str': 'Acute stroke'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0038088', 'cui_str': 'Sri Lanka'}, {'cui': 'C0037713', 'cui_str': 'South America'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0150305', 'cui_str': 'Positioning - therapy'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0454664', 'cui_str': 'Country'}]","[{'cui': 'C0582540', 'cui_str': 'Head position finding'}, {'cui': 'C0751956', 'cui_str': 'Acute stroke'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1293898', 'cui_str': 'Head up'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0150305', 'cui_str': 'Positioning - therapy'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0035124', 'cui_str': 'Reperfusion'}]",,0.177773,"With Australia/UK as reference, patients in other regions had a lower probability of receiving reperfusion therapy, especially in India/Sri Lanka (adjusted odds ratio [aOR] 0.27, 95% confidence interval [CI] 0.12-0.63) and multidisciplinary care (mainly in formal dysphagia assessment, physiotherapy and occupational therapy).
","[{'ForeName': 'Menglu', 'Initials': 'M', 'LastName': 'Ouyang', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia; The George Institute China at Peking University Health Science Center, Beijing, China.'}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Department of Neurology, Shenyang First People's Hospital, Shenyang, China.""}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Song', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia; The George Institute China at Peking University Health Science Center, Beijing, China.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Billot', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Thompson', 'Initials': 'T', 'LastName': 'Robinson', 'Affiliation': 'Department of Cardiovascular Sciences and NIHR Leicester Biomedical Research Centre, University of Leicester, Leicester, UK.'}, {'ForeName': 'Pablo M', 'Initials': 'PM', 'LastName': 'Lavados', 'Affiliation': 'Unidad de Neurología Vascular, Servicio de Neurología, Departmento de Neurologia y Psiquiatria, Clínica Alemana de Santiago, Facultad de Medicina, Clínica Alemana, Universidad del Desarrollo, Chile.'}, {'ForeName': 'Hisatomi', 'Initials': 'H', 'LastName': 'Arima', 'Affiliation': 'Department of Preventive Medicine and Public Health, Faculty of Medicine, Fukuoka University, Fukuoka, Japan.'}, {'ForeName': 'Maree L', 'Initials': 'ML', 'LastName': 'Hackett', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia; Faculty of Health and Wellbeing, University of Central Lancashire, Preston, Lancashire, UK.'}, {'ForeName': 'Verónica V', 'Initials': 'VV', 'LastName': 'Olavarría', 'Affiliation': 'Unidad de Neurología Vascular, Servicio de Neurología, Departmento de Neurologia y Psiquiatria, Clínica Alemana de Santiago, Facultad de Medicina, Clínica Alemana, Universidad del Desarrollo, Chile.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Muñoz-Venturelli', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia; Centro de Estudios Clínicos, Instituto de Ciencias e Innovación en Medicina, Facultad de Medicina Clínica Alemana Universidad del Desarrollo, Santiago, Chile.'}, {'ForeName': 'Sandy', 'Initials': 'S', 'LastName': 'Middleton', 'Affiliation': ""Nursing Research Institute, St Vincent's Health Network Sydney, St Vincent's Hospital, Melbourne and Australian Catholic University, Sydney, Australia.""}, {'ForeName': 'Caroline L', 'Initials': 'CL', 'LastName': 'Watkins', 'Affiliation': 'Faculty of Health and Wellbeing, University of Central Lancashire, Preston, Lancashire, UK.'}, {'ForeName': 'Octavio M', 'Initials': 'OM', 'LastName': 'Pontes-Neto', 'Affiliation': 'Stroke Service - Neurology Division, Department of Neuroscience and Behavioral Sciences, Ribeirão Preto Medical School, University of Sao Paulo, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Tsong-Hai', 'Initials': 'TH', 'LastName': 'Lee', 'Affiliation': 'Stroke Center and Department of Neurology, Linkou Chang Gung Memorial Hospital and College of Medicine, Chang Gung University, Taoyuan, Taiwan.'}, {'ForeName': 'Alejandro M', 'Initials': 'AM', 'LastName': 'Brunser', 'Affiliation': 'Unidad de Neurología Vascular, Servicio de Neurología, Departmento de Neurologia y Psiquiatria, Clínica Alemana de Santiago, Facultad de Medicina, Clínica Alemana, Universidad del Desarrollo, Chile.'}, {'ForeName': 'Craig S', 'Initials': 'CS', 'LastName': 'Anderson', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia; The George Institute China at Peking University Health Science Center, Beijing, China; Centro de Estudios Clínicos, Instituto de Ciencias e Innovación en Medicina, Facultad de Medicina Clínica Alemana Universidad del Desarrollo, Santiago, Chile; Neurology Department, Royal Prince Alfred Hospital, Sydney Health Partners, Sydney, Australia; Heart Health Research Center, Beijing, China. Electronic address: canderson@georgeinstitute.org.au.'}]",Journal of the neurological sciences,['10.1016/j.jns.2020.117187']
1599,33075621,Co-ingested vinegar-soaked or preloaded dried apple mitigated acute postprandial glycemia of rice meal in healthy subjects under equicarbohydrate conditions.,"This study investigated 2 possible approaches to dietary control of acute postprandial responses to a rice-based meal under equicarbohydrate conditions: (1) a dried apple (DA) preload and (2) co-ingestion of vinegar-soaked DA. We hypothesized that both approaches would counteract hyperglycemia with no negative effect on satiety, possibly explained by an inhibitory effect on digestive enzyme activity and/or the effect of the sugar component of the DA. Fifteen healthy female subjects consumed (1) rice, (2) co-ingestion of DA and rice (DA + R), (3) DA preload and rice (PDA + R), (4) rice with sugar solution (same sugar profile as in DA) preloaded (PSS + R), or (5) co-ingestion of rice with vinegar-soaked DA (VDA + R) in a randomized crossover trial. Acute postprandial glycemic response tests and subjective satiety tests were conducted for each test meal. Compared with rice reference, the PA + R and PSS + R achieved 31.4% and 36.3% reduction of the incremental area under the curve 0-120 , 24.3% and 27.0% decreases in the average glucose peak, along with 21.6% and 27.0% decreases in glycemic excursion in 240 minutes, whereas the VDA + R resulted 42.4%, 27.0%, and 29.7% reductions in the incremental area under the curve 0-120 , peak, and glycemic excursion, respectively. The DA-containing meals had no effect or a favorable effect on satiety. The in vitro assay found larger resistant starch and smaller rapid digestible starch fractions in DA + R and VDA + R meals compared to those of the rice reference (P < .001). The result of this study supported the research hypothesis, and the DA-containing meals could be considered as a potential dietary approach for glycemic management.",2020,The DA-containing meals had no effect or a favorable effect on satiety.,"['Fifteen healthy female subjects consumed (1) rice, (2', 'healthy subjects under equicarbohydrate conditions']","['co-ingestion of DA and rice (DA\u202f+\u202fR), (3) DA preload and rice (PDA\u202f+\u202fR), (4) rice with sugar solution (same sugar profile as in DA) preloaded (PSS\u202f+\u202fR), or (5) co-ingestion of rice with vinegar-soaked DA (VDA\u202f+\u202fR', 'rice-based meal under equicarbohydrate conditions: (1) a dried apple (DA) preload and (2) co-ingestion of vinegar-soaked DA', 'Co-ingested vinegar-soaked or preloaded dried apple']","['satiety', 'larger resistant starch and smaller rapid digestible starch fractions', 'Acute postprandial glycemic response tests and subjective satiety tests', 'average glucose peak', 'glycemic excursion']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0035567', 'cui_str': 'Rice'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0453298', 'cui_str': 'Dried apple'}, {'cui': 'C0035567', 'cui_str': 'Rice'}, {'cui': 'C0013274', 'cui_str': 'Patent ductus arteriosus'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0148405', 'cui_str': 'Vinegar'}, {'cui': 'C0204774', 'cui_str': 'Soak'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0036239', 'cui_str': 'Satiety'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0038179', 'cui_str': 'Starch'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0444505', 'cui_str': 'Peak'}]",15.0,0.0183585,The DA-containing meals had no effect or a favorable effect on satiety.,"[{'ForeName': 'Wenqi', 'Initials': 'W', 'LastName': 'Zhao', 'Affiliation': 'College of Food Science and nutritional Engineering, China Agricultural University, Beijing 100083, China. Electronic address: zhaowenqi@cau.edu.cn.'}, {'ForeName': 'Linlin', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'College of Food Science and nutritional Engineering, China Agricultural University, Beijing 100083, China. Electronic address: lynn9523@126.com.'}, {'ForeName': 'Zhihong', 'Initials': 'Z', 'LastName': 'Fan', 'Affiliation': 'College of Food Science and nutritional Engineering, China Agricultural University, Beijing 100083, China; Key Laboratory of Precision Nutrition and Food Quality, Department of Nutrition and Health, China Agricultural University, Beijing 100083. Electronic address: daisyfan@cau.edu.cn.'}, {'ForeName': 'Jiachan', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': 'College of Food Science and nutritional Engineering, China Agricultural University, Beijing 100083, China. Electronic address: jiacanlu0613@163.com.'}, {'ForeName': 'Ruixing', 'Initials': 'R', 'LastName': 'Zhu', 'Affiliation': 'College of Food Science and nutritional Engineering, China Agricultural University, Beijing 100083, China. Electronic address: zhuruixin07@126.com.'}, {'ForeName': 'Yixue', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'College of Food Science and nutritional Engineering, China Agricultural University, Beijing 100083, China. Electronic address: xiaoc0105@126.com.'}, {'ForeName': 'Xuejiao', 'Initials': 'X', 'LastName': 'Lu', 'Affiliation': 'College of Food Science and nutritional Engineering, China Agricultural University, Beijing 100083, China. Electronic address: feirlu@163.com.'}]","Nutrition research (New York, N.Y.)",['10.1016/j.nutres.2020.09.003']
1600,33075644,Additive effectiveness and feasibility of a theory-driven instant assessment and feedback system in brief cannabis intervention: A randomised controlled trial.,"Assessment and personalised feedback are important components of brief interventions (BIs) for cannabis use. A key outcome is to increase motivation to change during this short interaction. The diversity of available assessments and time burden scoring them pose a challenge for routine use in clinical practice. An instant assessment and feedback (iAx) system was developed to administer assessments informed by bioSocial Cognitive Theory, that were instantly scored and benchmarked against clinical norms, to provide patient feedback and guide treatment planning. This study evaluated the feasibility and additive effectiveness of the iAx on motivation to change cannabis use, when compared to treatment as usual (TAU), in a single-session BI. A randomised controlled trial was conducted in a public hospital alcohol and drug outpatient clinic. Eighty-seven cannabis users (M age  = 26.41; 66% male) were assigned to the BI utilising the iAx (iAx; n = 44) or to the standard BI (TAU; n = 43). Patients completed pre- and post-BI assessments of motivation to change and a post-BI measure of treatment satisfaction. Practitioners completed a feedback survey. Patients receiving iAx reported a significantly greater increase in motivation to change from pre- to post-BI compared to patients receiving TAU (d = 0.49, p = .03). Treatment satisfaction was high across both conditions, with no significant difference between groups (p = .57). Practitioners also reported a high level of satisfaction with the iAx system. In summary, findings support the feasibility and additive effectiveness of the iAx to enhance patient motivation during cannabis BI.",2020,"Treatment satisfaction was high across both conditions, with no significant difference between groups (p = .57).","['Eighty-seven cannabis users (M age \xa0=\xa026.41; 66% male', 'brief cannabis intervention', 'public hospital alcohol and drug outpatient clinic']",['theory-driven instant assessment and feedback system'],"['Treatment satisfaction', 'motivation']","[{'cui': 'C4517895', 'cui_str': '87'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0020022', 'cui_str': 'Public Hospitals'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}]",87.0,0.0509742,"Treatment satisfaction was high across both conditions, with no significant difference between groups (p = .57).","[{'ForeName': 'Zoë E', 'Initials': 'ZE', 'LastName': 'Papinczak', 'Affiliation': 'National Centre for Youth Substance Use Research, The University of Queensland, Brisbane, QLD 4072, Australia; School of Psychology, The University of Queensland, Brisbane, QLD 4072, Australia.'}, {'ForeName': 'Jason P', 'Initials': 'JP', 'LastName': 'Connor', 'Affiliation': 'National Centre for Youth Substance Use Research, The University of Queensland, Brisbane, QLD 4072, Australia; Discipline of Psychiatry, School of Medicine, The University of Queensland, Brisbane, QLD 4029, Australia; Alcohol and Drug Assessment Unit, Princess Alexandra Hospital, Brisbane, QLD 4102, Australia.'}, {'ForeName': 'Gerald F X', 'Initials': 'GFX', 'LastName': 'Feeney', 'Affiliation': 'National Centre for Youth Substance Use Research, The University of Queensland, Brisbane, QLD 4072, Australia; Alcohol and Drug Assessment Unit, Princess Alexandra Hospital, Brisbane, QLD 4102, Australia.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Gullo', 'Affiliation': 'National Centre for Youth Substance Use Research, The University of Queensland, Brisbane, QLD 4072, Australia; Alcohol and Drug Assessment Unit, Princess Alexandra Hospital, Brisbane, QLD 4102, Australia. Electronic address: m.gullo@uq.edu.au.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106690']
1601,33075711,The effect of dry needling on gastrocnemius muscle stiffness and strength in participants with latent trigger points.,"Abnormal muscle stiffness is a potential complication after injury and identifying interventions that modify muscle stiffness may be useful to promote recovery. The purpose of this study was to identify the short-term effects of dry needling (DN) on resting and contracted gastrocnemius muscle stiffness and strength of the triceps surae in individuals with latent myofascial trigger points (MTrPs). In this randomized controlled trial, 52 individuals received two DN treatment sessions to latent MTrPs and 50 individuals received two sham needling sessions. Resting and contracted muscle stiffness were assessed both at the treatment site and a standardized central site in the medial gastrocnemius head immediately post-treatment and one week after the last session. There were significant group by time interactions for resting muscle stiffness at the site of the MTrP (p = .03), but not at the central site (p = .29). Post-needling between group comparison indicated that the DN group had significantly lower resting muscle stiffness at the site of the MTrP than the sham group after adjusting for baseline differences. There were no significant between group differences in contracted muscle stiffness or muscle strength. Identifying strategies that can reduce aberrant muscle stiffness may help to guide management of individuals with neuromuscular pain-related conditions. Level of evidence: Therapy, level 2.",2020,"There were significant group by time interactions for resting muscle stiffness at the site of the MTrP (p = .03), but not at the central site (p = .29).","['participants with latent trigger points', '52 individuals received two DN treatment sessions to latent MTrPs and 50 individuals received two', 'individuals with latent myofascial trigger points (MTrPs', 'individuals with neuromuscular pain-related conditions']","['sham needling sessions', 'dry needling', 'dry needling (DN']","['resting muscle stiffness', 'contracted muscle stiffness or muscle strength', 'gastrocnemius muscle stiffness and strength', 'Level of evidence', 'Resting and contracted muscle stiffness', 'time interactions for resting muscle stiffness']","[{'cui': 'C0205275', 'cui_str': 'Latent'}, {'cui': 'C0458343', 'cui_str': 'Trigger point'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0394648', 'cui_str': 'Dry needle acupuncture'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1405031', 'cui_str': 'Neuromuscular pain'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0394648', 'cui_str': 'Dry needle acupuncture'}]","[{'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0221170', 'cui_str': 'Muscular stiffness'}, {'cui': 'C0332522', 'cui_str': 'Contracts'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0242691', 'cui_str': 'Gastrocnemius muscle structure'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}]",52.0,0.067405,"There were significant group by time interactions for resting muscle stiffness at the site of the MTrP (p = .03), but not at the central site (p = .29).","[{'ForeName': 'S R', 'Initials': 'SR', 'LastName': 'Albin', 'Affiliation': 'Regis University, School of Physical Therapy, Denver, CO, United States.'}, {'ForeName': 'S L', 'Initials': 'SL', 'LastName': 'Koppenhaver', 'Affiliation': 'Baylor University Doctoral Program in Physical Therapy, Waco, TX, United States.'}, {'ForeName': 'C W', 'Initials': 'CW', 'LastName': 'MacDonald', 'Affiliation': 'Regis University, School of Physical Therapy, Denver, CO, United States.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Capoccia', 'Affiliation': 'Regis University, School of Physical Therapy, Denver, CO, United States.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Ngo', 'Affiliation': 'Regis University, School of Physical Therapy, Denver, CO, United States.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Phippen', 'Affiliation': 'Regis University, School of Physical Therapy, Denver, CO, United States.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Pineda', 'Affiliation': 'Regis University, School of Physical Therapy, Denver, CO, United States.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Wendlandt', 'Affiliation': 'Regis University, School of Physical Therapy, Denver, CO, United States.'}, {'ForeName': 'L R', 'Initials': 'LR', 'LastName': 'Hoffman', 'Affiliation': 'Regis University, School of Physical Therapy, Denver, CO, United States.'}]",Journal of electromyography and kinesiology : official journal of the International Society of Electrophysiological Kinesiology,['10.1016/j.jelekin.2020.102479']
1602,33075775,Dose-Response Effect of Fluoride Dentifrices on De-/Remineralization of Root Dentine in situ.,"The present study aimed to evaluate the effect of fluoride (F) dentifrice with different F concentrations on root dentine de-/remineralization. Ten healthy volunteers took part in this randomized, double-blinded, cross-over, and split-mouth in situ experimental study. During 4 phases of 7 days, they wore a palatal appliance containing 4 bovine dentine blocks (2 sound and 2 with caries) of 4 × 4 × 2 mm. Treatments were performed with silica-based dentifrices containing 0, 700, 1,300, and 5,000 µg F/g (F as NaF). To provide a cariogenic challenge, a 20% sucrose solution was dripped 3 and 8 times daily on the carious-like and sound blocks, respectively. After each experimental phase, the percentage of surface hardness loss (%SHL) or recovery (%SHR) was calculated and the fluoride concentration in the biofilm was determined. The statistical analysis was performed using ANOVA and the Tukey post hoc test with p at 5%. The relationship between variables was analyzed by linear regression. The results showed a lower %SHL when 5,000 µg F/g dentifrice was used but without a statistically significant difference from the conventional one (1,300 µg F/g). Regarding remineralization and F in biofilms, the high-fluoride dentifrice was expressively superior in mineral replacement on the surface and in the F concentration in the biofilms, respectively, compared to the other 3 products (p < 0.05). Also, a significant linear fit between mineral loss/gain, F in biofilms, and fluoride concentration in the dentifrices could be observed. In conclusion, a dose-response F effect was observed, and the high-fluoride dentifrice was effective in enhancing root dentine remineralization in this short-term in situ study.",2020,"Regarding remineralization and F in biofilms, the high-fluoride dentifrice was expressively superior in mineral replacement on the surface and in the F concentration in the biofilms, respectively, compared to the other 3 products (p < 0.05).",['Ten healthy volunteers'],"['Fluoride Dentifrices', 'palatal appliance containing 4 bovine dentine blocks', 'fluoride (F) dentifrice']","['root dentine remineralization', 'percentage of surface hardness loss (%SHL) or recovery (%SHR', 'mineral loss/gain, F in biofilms, and fluoride concentration', 'De-/Remineralization of Root Dentine']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C0011427', 'cui_str': 'Dentifrice'}, {'cui': 'C0700374', 'cui_str': 'Palatal'}, {'cui': 'C1542418', 'cui_str': 'Appliance'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}]","[{'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0018599', 'cui_str': 'Hard'}, {'cui': 'C1439030', 'cui_str': 'SHORT ROOT protein, Arabidopsis'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0081786', 'cui_str': 'Biofilm'}, {'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",10.0,0.0777632,"Regarding remineralization and F in biofilms, the high-fluoride dentifrice was expressively superior in mineral replacement on the surface and in the F concentration in the biofilms, respectively, compared to the other 3 products (p < 0.05).","[{'ForeName': 'José', 'Initials': 'J', 'LastName': 'Leal', 'Affiliation': 'Department of Restorative Dentistry, Federal University of Piaui, Teresina, Brazil.'}, {'ForeName': 'Robson', 'Initials': 'R', 'LastName': 'Ferreira', 'Affiliation': 'Department of Restorative Dentistry, Federal University of Piaui, Teresina, Brazil.'}, {'ForeName': 'Cinthia', 'Initials': 'C', 'LastName': 'Tabchoury', 'Affiliation': 'Piracicaba Dental School, UNICAMP, Piracicaba, Brazil.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lingström', 'Affiliation': 'Department of Cariology, Institute of Odontology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Glauber', 'Initials': 'G', 'LastName': 'Vale', 'Affiliation': 'Department of Restorative Dentistry, Federal University of Piaui, Teresina, Brazil, glauber@ufpi.edu.br.'}]",Caries research,['10.1159/000510535']
1603,33075782,The Acute Effect of Meal Timing on the Gut Microbiome and the Cardiometabolic Health of the Host: A Crossover Randomized Control Trial.,"PURPOSE


The interaction of diet with gut microbiome has been implicated in the onset of cardiovascular disease. The gut microbiome displays diurnal rhythms, which may be influenced by meal timing.
OBJECTIVE


This study aimed to investigate the effect of the timing of main meal consumption on the microbiome and cardiometabolic biomarkers of the host.
METHODS


Seventeen healthy adults randomly consumed an isocaloric diet for 7 days, twice, by alternating lunch with dinner meals, and with a 2-week washout in-between. Sixty percent of the participants' daily energy requirements was consumed either as lunch or dinner, respectively. Meals were provided free to the participants. All fecal samples produced the last 3 days of each intervention were collected and analyzed for microbial profiling (16S rRNA gene amplicon sequencing), quantitative estimation of representative bacterial groups (qPCR) of the gut microbiome, and the output of short-chain fatty acids (SCFA) in feces. Fasted blood samples were analyzed for low-grade inflammatory biomarkers, blood lipids, insulin, and glucose levels. Cumulative energy loss in feces was measured over the collection period using bomb calorimetry.
RESULTS


Meal timing had no significant effects on fecal SCFA output, energy loss in feces, microbial community profiling, and bacterial species relative abundance. The absolute concentration of Escherichia coli was significantly higher after the large lunch intervention (p = 0.02). No effects on blood biomarkers of cardiometabolic health were observed.
CONCLUSIONS


In a well-controlled study, main meal timing displayed minimal acute effects on the gut microbiome composition, its diet-related function, and blood biomarkers of cardiometabolic health.",2020,The absolute concentration of Escherichia coli was significantly higher after the large lunch intervention (p = 0.02).,"['Gut Microbiome and the Cardiometabolic Health of the Host', 'Seventeen healthy adults randomly consumed an']","['main meal consumption', 'isocaloric diet']","['blood biomarkers of cardiometabolic health', 'gut microbiome composition, its diet-related function, and blood biomarkers of cardiometabolic health', 'low-grade inflammatory biomarkers, blood lipids, insulin, and glucose levels', 'Cumulative energy loss in feces', 'fecal SCFA output, energy loss in feces, microbial community profiling, and bacterial species relative abundance', 'absolute concentration of Escherichia coli']","[{'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1962916', 'cui_str': 'Low grade (lymphoma)'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0014834', 'cui_str': 'Escherichia coli'}]",17.0,0.054198,The absolute concentration of Escherichia coli was significantly higher after the large lunch intervention (p = 0.02).,"[{'ForeName': 'Rodanthi Thalia', 'Initials': 'RT', 'LastName': 'Papadopoulou', 'Affiliation': 'Human Nutrition, School of Medicine, Dentistry and Nursing, University of Glasgow, New Lister Building, Glasgow, United Kingdom.'}, {'ForeName': 'Maria Rafailia', 'Initials': 'MR', 'LastName': 'Theodorou', 'Affiliation': 'Human Nutrition, School of Medicine, Dentistry and Nursing, University of Glasgow, New Lister Building, Glasgow, United Kingdom.'}, {'ForeName': 'Chi San', 'Initials': 'CS', 'LastName': 'Ieong', 'Affiliation': 'Human Nutrition, School of Medicine, Dentistry and Nursing, University of Glasgow, New Lister Building, Glasgow, United Kingdom.'}, {'ForeName': 'Katrina', 'Initials': 'K', 'LastName': 'Ballantyne', 'Affiliation': 'Human Nutrition, School of Medicine, Dentistry and Nursing, University of Glasgow, New Lister Building, Glasgow, United Kingdom.'}, {'ForeName': 'Danae', 'Initials': 'D', 'LastName': 'Marshall', 'Affiliation': 'Human Nutrition, School of Medicine, Dentistry and Nursing, University of Glasgow, New Lister Building, Glasgow, United Kingdom.'}, {'ForeName': 'Anais', 'Initials': 'A', 'LastName': 'Verney', 'Affiliation': 'Human Nutrition, School of Medicine, Dentistry and Nursing, University of Glasgow, New Lister Building, Glasgow, United Kingdom.'}, {'ForeName': 'Marine', 'Initials': 'M', 'LastName': 'Roig', 'Affiliation': 'Human Nutrition, School of Medicine, Dentistry and Nursing, University of Glasgow, New Lister Building, Glasgow, United Kingdom.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Nichols', 'Affiliation': 'Human Nutrition, School of Medicine, Dentistry and Nursing, University of Glasgow, New Lister Building, Glasgow, United Kingdom.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Gerasimidis', 'Affiliation': 'Human Nutrition, School of Medicine, Dentistry and Nursing, University of Glasgow, New Lister Building, Glasgow, United Kingdom, konstantinos.gerasimidis@glasgow.ac.uk.'}]",Annals of nutrition & metabolism,['10.1159/000510646']
1604,33075788,Low FODMAP Diet Is Not Effective in Children with Functional Abdominal Pain: A Randomized Controlled Trial.,"INTRODUCTION


A diet low in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAP) has been shown to reduce symptoms among adult patients and children with irritable bowel syndrome. There are no studies investigating the effectiveness of the low FODMAP diet in pediatric patients with functional abdominal pain (FAP).
OBJECTIVE


The study aimed to evaluate the effectiveness of the low FODMAP diet in reducing gastrointestinal symptoms in children with FAP in comparison to the control diet based on the National Institute for Health and Care Excellence (NICE) guidelines.
METHODS


Twenty-seven children with diagnosed FAP were randomized to 2 groups. Each group received an intervention: the low FODMAP diet or the diet based on NICE. All food was prepared and delivered by a catering company. Data regarding gastrointestinal symptoms were recorded by participants during the 2-week baseline assessment and 4-week dietary intervention. The frequencies of abdominal pain and stools were reported as a number of events per day. The severity of abdominal pain was assessed using the Wong-Baker FACES Pain Rating Scale. The assessment of stool consistency was based on the Bristol Stool Form Scale.
RESULTS


The tendency toward the improvement in abdominal symptoms was noted in the low FODMAP group but without statistical significance. No significant differences in stool consistency were observed in this group. The NICE group experienced significant reduction in abdominal pain intensity and frequency (p < 0.01) and improvement in stool consistency (93% reporting normal stool, p < 0.05).
CONCLUSIONS


The results of this pilot study suggest that the low FODMAP diet is not effective in the reduction of symptoms in children with FAP.",2020,"The NICE group experienced significant reduction in abdominal pain intensity and frequency (p < 0.01) and improvement in stool consistency (93% reporting normal stool, p < 0.05).
","['children with FAP in comparison to the control diet based on the National Institute for Health and Care Excellence (NICE) guidelines', 'pediatric patients with functional abdominal pain (FAP', 'children with FAP', 'adult patients and children with irritable bowel syndrome', 'Children with Functional Abdominal Pain', 'Twenty-seven children with diagnosed FAP']","['Low FODMAP Diet', 'intervention: the low FODMAP diet or the diet based on NICE', 'low FODMAP diet']","['abdominal symptoms', 'gastrointestinal symptoms', 'abdominal pain intensity and frequency', 'severity of abdominal pain', 'Baker FACES Pain Rating Scale', 'frequencies of abdominal pain and stools', 'stool consistency']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1609533', 'cui_str': 'Functional abdominal pain'}, {'cui': 'C0743195', 'cui_str': 'Dietary control'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0028959', 'cui_str': 'Oligosaccharide'}, {'cui': 'C0012611', 'cui_str': 'Disaccharide'}, {'cui': 'C0026492', 'cui_str': 'Monosaccharide'}, {'cui': 'C0071629', 'cui_str': 'polyol'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0740651', 'cui_str': 'Abdominal symptom'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0238749', 'cui_str': 'Baker, general'}, {'cui': 'C0015468', 'cui_str': 'Pain in face'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0426740', 'cui_str': 'Consistency of stool'}]",27.0,0.0363635,"The NICE group experienced significant reduction in abdominal pain intensity and frequency (p < 0.01) and improvement in stool consistency (93% reporting normal stool, p < 0.05).
","[{'ForeName': 'Katarzyna Mirosława', 'Initials': 'KM', 'LastName': 'Boradyn', 'Affiliation': 'Department of Human Nutrition, Faculty of Food Sciences, University of Warmia and Mazury in Olsztyn, Olsztyn, Poland, katarzyna.boradyn@uwm.edu.pl.'}, {'ForeName': 'Katarzyna Eufemia', 'Initials': 'KE', 'LastName': 'Przybyłowicz', 'Affiliation': 'Department of Human Nutrition, Faculty of Food Sciences, University of Warmia and Mazury in Olsztyn, Olsztyn, Poland.'}, {'ForeName': 'Elżbieta', 'Initials': 'E', 'LastName': 'Jarocka-Cyrta', 'Affiliation': 'Department of Pediatrics, Gastroenterology and Nutrition, Faculty of Medicine Collegium Medicum, University of Warmia and Mazury in Olsztyn, Olsztyn, Poland.'}]",Annals of nutrition & metabolism,['10.1159/000510795']
1605,33075789,Efficacy and Safety of Intravenous Tramadol versus Intravenous Paracetamol for Relief of Acute Pain of Primary Dysmenorrhea: A Randomized Controlled Trial.,"INTRODUCTION


Many pharmaceutical, surgical, and complementary medical interventions are used for primary dysmenorrhea treatment. However, no consensus has been reached about the most effective intervention.
OBJECTIVE


To compare the efficacy and safety of IV tramadol versus IV paracetamol in relieving acute pain of primary dysmenorrhea.
METHODS


This randomized controlled trial was conducted in a tertiary referral hospital and included 100 patients between 18 and 35 years old diagnosed with primary dysmenorrhea. Patients received either 1-g paracetamol or 100-mg tramadol in 100-mL normal saline as an IV infusion over 10 min. Pain intensity was measured by using a visual analog scale at 15, 30, 60 min, and 2 h. We recorded drug side effects and requirements for rescue analgesics.
RESULTS


Pain scores were significantly lower in the tramadol group compared with the paracetamol group at 15, 30, 60 min, and 2 h (p < 0.001). Fewer patients in the tramadol group needed rescue analgesics compared with the paracetamol group (p = 0.04). No significant differences were reported in side effects between both groups.
CONCLUSIONS


IV tramadol is superior to IV paracetamol in relieving acute pain of primary dysmenorrhea with a comparable side effect profile.",2020,Fewer patients in the tramadol group needed rescue analgesics compared with the paracetamol group (p = 0.04).,"['Acute Pain of Primary Dysmenorrhea', 'tertiary referral hospital and included 100 patients between 18 and 35 years old diagnosed with primary dysmenorrhea']","['Tramadol', 'tramadol', 'IV tramadol', 'Paracetamol', '1-g paracetamol or 100-mg tramadol', 'paracetamol']","['efficacy and safety', 'Pain scores', 'Efficacy and Safety', 'side effects', 'rescue analgesics', 'Pain intensity']","[{'cui': 'C0184567', 'cui_str': 'Acute pain'}, {'cui': 'C0149875', 'cui_str': 'Primary dysmenorrhea'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",100.0,0.0958528,Fewer patients in the tramadol group needed rescue analgesics compared with the paracetamol group (p = 0.04).,"[{'ForeName': 'Nevein Kamal', 'Initials': 'NK', 'LastName': 'Ghamry', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Ahmed Said', 'Initials': 'AS', 'LastName': 'Ali', 'Affiliation': 'Department of Histology, Faculty of Medicine, Al-Azhar University, Cairo, Egypt, ahmedsaidali987@gmail.com.'}, {'ForeName': 'Mohammad Abrar', 'Initials': 'MA', 'LastName': 'Shareef', 'Affiliation': 'Department of Family Medicine, Sebasticook Valley Hospital, Pittsfield, Maine, USA.'}, {'ForeName': 'Abdulhadi A', 'Initials': 'AA', 'LastName': 'AlAmodi', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public School, Jackson State University, Jackson, Mississippi, USA.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Hamza', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Abbas', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Hammad Ali', 'Initials': 'HA', 'LastName': 'Fadlalmola', 'Affiliation': 'Nursing College, Taibah University, Medina, Saudi Arabia.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Alalfy', 'Affiliation': 'Reproductive Health and Family Planning Department, National Research Centre, Giza, Egypt.'}, {'ForeName': 'Ahmed Omar', 'Initials': 'AO', 'LastName': 'Mahmoud', 'Affiliation': 'Department of Anesthesiology and Intensive Care Unit, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Yomna', 'Initials': 'Y', 'LastName': 'Islam', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}]",Gynecologic and obstetric investigation,['10.1159/000510268']
1606,33075796,What Should Clinicians Tell Patients about Placebo and Nocebo Effects? Practical Considerations Based on Expert Consensus.,"INTRODUCTION


Clinical and laboratory studies demonstrate that placebo and nocebo effects influence various symptoms and conditions after the administration of both inert and active treatments.
OBJECTIVE


There is an increasing need for up-to-date recommendations on how to inform patients about placebo and nocebo effects in clinical practice and train clinicians how to disclose this information.
METHODS


Based on previous clinical recommendations concerning placebo and nocebo effects, a 3-step, invitation-only Delphi study was conducted among an interdisciplinary group of internationally recognized experts. The study consisted of open- and closed-ended survey questions followed by a final expert meeting. The surveys were subdivided into 3 parts: (1) informing patients about placebo effects, (2) informing patients about nocebo effects, and (3) training clinicians how to communicate this information to the patients.
RESULTS


There was consensus that communicating general information about placebo and nocebo effects to patients (e.g., explaining their role in treatment) could be beneficial, but that such information needs to be adjusted to match the specific clinical context (e.g., condition and treatment). Experts also agreed that training clinicians to communicate about placebo and nocebo effects should be a regular and integrated part of medical education that makes use of multiple formats, including face-to-face and online modalities.
CONCLUSIONS


The current 3-step Delphi study provides consensus-based recommendations and practical considerations for disclosures about placebo and nocebo effects in clinical practice. Future research is needed on how to optimally tailor information to specific clinical conditions and patients' needs, and on developing standardized disclosure training modules for clinicians.",2020,"There is an increasing need for up-to-date recommendations on how to inform patients about placebo and nocebo effects in clinical practice and train clinicians how to disclose this information.
",[],['placebo'],[],[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.0715086,"There is an increasing need for up-to-date recommendations on how to inform patients about placebo and nocebo effects in clinical practice and train clinicians how to disclose this information.
","[{'ForeName': 'Andrea W M', 'Initials': 'AWM', 'LastName': 'Evers', 'Affiliation': 'Health, Medical and Neuropsychology Unit, Institute of Psychology, Leiden University, Leiden, The Netherlands, a.evers@fsw.leidenuniv.nl.'}, {'ForeName': 'Luana', 'Initials': 'L', 'LastName': 'Colloca', 'Affiliation': 'Departments of Pain Translational Symptoms Science and Anesthesiology, School of Nursing and Medicine, University of Maryland Baltimore, Baltimore, Maryland, USA.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Blease', 'Affiliation': 'General Medicine and Primary Care, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Gaab', 'Affiliation': 'Faculty of Psychology, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Karin B', 'Initials': 'KB', 'LastName': 'Jensen', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Lauren Y', 'Initials': 'LY', 'LastName': 'Atlas', 'Affiliation': 'National Center for Complementary and Integrative Health, National Institute of Mental Health, and National Institute on Drug Abuse, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Chris J', 'Initials': 'CJ', 'LastName': 'Beedie', 'Affiliation': 'School of Psychology, University of Kent, Canterbury, United Kingdom.'}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'Benedetti', 'Affiliation': 'Physiology and Neuroscience, University of Turin Medical School, Turin, Italy.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Bingel', 'Affiliation': 'Department of Neurology, University Hospital Essen, Essen, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Büchel', 'Affiliation': 'Department of Systems Neuroscience, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Jet', 'Initials': 'J', 'LastName': 'Bussemaker', 'Affiliation': 'Public Health and Primary Care, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Colagiuri', 'Affiliation': 'School of Psychology, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Alia J', 'Initials': 'AJ', 'LastName': 'Crum', 'Affiliation': 'Department of Psychology, Stanford University, Stanford, California, USA.'}, {'ForeName': 'Damien G', 'Initials': 'DG', 'LastName': 'Finniss', 'Affiliation': 'Royal North Shore Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Andrew L', 'Initials': 'AL', 'LastName': 'Geers', 'Affiliation': 'Department of Psychology, University of Toledo, Toledo, Ohio, USA.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Howick', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Regine', 'Initials': 'R', 'LastName': 'Klinger', 'Affiliation': 'Center for Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Stefanie H', 'Initials': 'SH', 'LastName': 'Meeuwis', 'Affiliation': 'Health, Medical and Neuropsychology Unit, Institute of Psychology, Leiden University, Leiden, The Netherlands.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Meissner', 'Affiliation': 'Division of Health Promotion, University of Applied Sciences, Coburg, Germany.'}, {'ForeName': 'Vitaly', 'Initials': 'V', 'LastName': 'Napadow', 'Affiliation': 'Athinoula A. Martinos Center for Biomedical Imaging, Charlestown, Massachusetts, USA.'}, {'ForeName': 'Keith J', 'Initials': 'KJ', 'LastName': 'Petrie', 'Affiliation': 'Department of Psychological Medicine, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Winfried', 'Initials': 'W', 'LastName': 'Rief', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Philipps University of Marburg, Marburg, Germany.'}, {'ForeName': 'Ionica', 'Initials': 'I', 'LastName': 'Smeets', 'Affiliation': 'Science Communication and Society, Institute of Biology, Leiden University, Leiden, The Netherlands.'}, {'ForeName': 'Tor D', 'Initials': 'TD', 'LastName': 'Wager', 'Affiliation': 'Department of Psychological and Brain Sciences, Dartmouth College, Hanover, New Hampshire, USA.'}, {'ForeName': 'Vishvarani', 'Initials': 'V', 'LastName': 'Wanigasekera', 'Affiliation': 'Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Lene', 'Initials': 'L', 'LastName': 'Vase', 'Affiliation': 'Department of Psychology and Behavioural Sciences, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Kelley', 'Affiliation': 'Beth Israel Deaconess Medical Center, Harvard Medical School, Program in Placebo Studies, Boston, Massachusetts, USA.'}, {'ForeName': 'Irving', 'Initials': 'I', 'LastName': 'Kirsch', 'Affiliation': 'Beth Israel Deaconess Medical Center, Harvard Medical School, Program in Placebo Studies, Boston, Massachusetts, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Psychotherapy and psychosomatics,['10.1159/000510738']
1607,33075806,Dapagliflozin Added to Verinurad Plus Febuxostat Further Reduces Serum Uric Acid in Hyperuricemia: The QUARTZ Study.,"CONTEXT


Combining a sodium-glucose cotransporter 2 (SGLT2) inhibitor with a xanthine oxidase inhibitor (XOI) and a urate transporter 1 (URAT1) inhibitor may enhance serum uric acid (sUA) lowering. However, concerns exist regarding high urinary UA (uUA) excretion rates and subsequent crystallization in renal tubules.
OBJECTIVE


To assess whether dapagliflozin added to verinurad, a selective URAT1 inhibitor, and febuxostat, an XOI, increases uUA excretion.
DESIGN


Randomized, placebo-controlled, 2-way crossover study (NCT03316131).
PATIENTS


Adults with asymptomatic hyperuricemia.
INTERVENTIONS


Subjects (N = 36) were randomized to oral once-daily 9 mg verinurad plus 80 mg febuxostat plus 10 mg dapagliflozin for 7 days and 7 days' oral once-daily 9 mg verinurad plus 80 mg febuxostat plus placebo with an intervening 7- to 21-day washout period.
MAIN OUTCOME MEASURE


Difference in peak uUA excretion between groups from baseline to Day 7. Secondary outcomes included changes in sUA levels and 24-hour uUA excretion.
RESULTS


Both regimens lowered mean peak uUA excretion (least squares mean changes from baseline: -12.9 mg/h [95% CI: -21.0 to -4.7] [dapagliflozin]; -13.2 mg/h [95% CI -21.3 to -5.0] [placebo]). sUA concentrations were lower with dapagliflozin (mean treatment difference -62.3 µmol/L [95% CI -82.8 to -41.8]). Dapagliflozin did not impact verinurad pharmacokinetics, its main metabolites, or febuxostat; or fasting plasma glucose levels versus verinurad plus febuxostat. There were no clinically relevant changes in safety parameters.
CONCLUSIONS


Dapagliflozin further reduced sUA without influencing uUA excretion, suggesting that its combination with verinurad and febuxostat at the doses tested does not adversely affect kidney function.",2020,"There were no clinically relevant changes in safety parameters.
","['Subjects (N = 36', 'Hyperuricemia', 'Adults with asymptomatic hyperuricemia']","['sodium-glucose cotransporter 2 (SGLT2) inhibitor with a xanthine oxidase inhibitor (XOI) and a urate transporter 1 (URAT1) inhibitor', 'febuxostat plus 10\xa0mg dapagliflozin', 'placebo', 'Dapagliflozin', 'Dapagliflozin Added to Verinurad Plus Febuxostat', 'febuxostat plus placebo', 'dapagliflozin']","['urinary UA (uUA) excretion rates', 'changes in sUA levels and 24-hour uUA excretion', 'fasting plasma glucose levels', 'sUA concentrations', 'mean peak uUA excretion', 'peak uUA excretion', 'kidney function']","[{'cui': 'C0740394', 'cui_str': 'Hyperuricemia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0348944', 'cui_str': 'Hyperuricemia without signs of inflammatory arthritis and tophaceous disease'}]","[{'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0302609', 'cui_str': 'Xanthine oxidase inhibitor'}, {'cui': 'C0534759', 'cui_str': 'urate transporter'}, {'cui': 'C0249529', 'cui_str': 'febuxostat'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C4519235', 'cui_str': 'verinurad'}]","[{'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0455272', 'cui_str': 'Serum urate measurement'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0232804', 'cui_str': 'Renal function'}]",36.0,0.176941,"There were no clinically relevant changes in safety parameters.
","[{'ForeName': 'Austin G', 'Initials': 'AG', 'LastName': 'Stack', 'Affiliation': 'University Hospital Limerick, School of Medicine and Health Research Institute (HRI), University of Limerick , Limerick, \xa0Ireland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Han', 'Affiliation': 'Parexel International, Glendale , California, \xa0USA.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Goldwater', 'Affiliation': 'Parexel International, Baltimore , Maryland, \xa0USA.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Johansson', 'Affiliation': 'AstraZeneca BioPharmaceuticals Research and Development , Gothenburg, \xa0Sweden.'}, {'ForeName': 'Nalina', 'Initials': 'N', 'LastName': 'Dronamraju', 'Affiliation': 'AstraZeneca BioPharmaceuticals Research and Development, Gaithersburg , Maryland, USA.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Oscarsson', 'Affiliation': 'AstraZeneca BioPharmaceuticals Research and Development , Gothenburg, \xa0Sweden.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Johnsson', 'Affiliation': 'AstraZeneca BioPharmaceuticals Research and Development , Gothenburg, \xa0Sweden.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Parkinson', 'Affiliation': 'AstraZeneca BioPharmaceuticals Research and Development , Gothenburg, \xa0Sweden.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Erlandsson', 'Affiliation': 'AstraZeneca BioPharmaceuticals Research and Development , Gothenburg, \xa0Sweden.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa748']
1608,33075807,The Effects of Kisspeptin on Brain Response to Food Images and Psychometric Parameters of Appetite in Healthy Men.,"CONTEXT


The hormone kisspeptin has crucial and well-characterised roles in reproduction. Emerging data from animal models also suggest that kisspeptin has important metabolic effects including modulation of food intake. However, to date there have been no studies exploring the effects of kisspeptin on brain responses to food stimuli in humans.
OBJECTIVE


To investigate the effects of kisspeptin administration on brain responses to visual food stimuli and psychometric parameters of appetite in healthy men.
DESIGN


Double-blinded, randomized, placebo-controlled crossover study.
PARTICIPANTS


Twenty-seven healthy, right-handed, eugonadal men (mean±SEM: age 26.5±1.1 yrs; BMI 23.9±0.4 kg/m 2).
INTERVENTION


Intravenous infusion of 1 nmol/kg/hr of kisspeptin or rate-matched vehicle over 75 minutes.Main Outcome Measures: Change in brain activity on functional MRI in response to visual food stimuli and change in psychometric parameters of appetite during kisspeptin administration compared to vehicle.
RESULTS


Kisspeptin administration at a bioactive dose did not affect brain responses to visual food stimuli or psychometric parameters of appetite compared to vehicle.
CONCLUSIONS


This is the first study in humans investigating the effects of kisspeptin on brain regions regulating appetite and demonstrates that peripheral administration of kisspeptin does not alter brain responses to visual food stimuli or psychometric parameters of appetite in healthy men. These data provide key translational insights to further our understanding of the interaction between reproduction and metabolism.",2020,"RESULTS


Kisspeptin administration at a bioactive dose did not affect brain responses to visual food stimuli or psychometric parameters of appetite compared to vehicle.
","['Healthy Men', 'healthy men', 'Twenty-seven healthy, right-handed, eugonadal men (mean±SEM: age 26.5±1.1 yrs; BMI 23.9±0.4\xa0kg/m 2']","['placebo', 'kisspeptin', 'Intravenous infusion of 1 nmol/kg/hr of kisspeptin or rate-matched vehicle', 'Kisspeptin']","['brain activity on functional MRI in response to visual food stimuli and change in psychometric parameters of appetite', 'Brain Response to Food Images and Psychometric Parameters of Appetite', 'brain responses to visual food stimuli or psychometric parameters of appetite']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0230370', 'cui_str': 'Structure of right hand'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0540309', 'cui_str': 'KISS1 protein, human'}, {'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}, {'cui': 'C0439283', 'cui_str': 'nmol/kg'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}]","[{'cui': 'C0443158', 'cui_str': 'Brain activity'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0033920', 'cui_str': 'Psychometric testing'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}]",27.0,0.0651705,"RESULTS


Kisspeptin administration at a bioactive dose did not affect brain responses to visual food stimuli or psychometric parameters of appetite compared to vehicle.
","[{'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Division of Diabetes, Endocrinology and Metabolism, Imperial College London, London, UK.'}, {'ForeName': 'Lysia', 'Initials': 'L', 'LastName': 'Demetriou', 'Affiliation': 'Invicro London, UK.'}, {'ForeName': 'Matthew B', 'Initials': 'MB', 'LastName': 'Wall', 'Affiliation': 'Invicro London, UK.'}, {'ForeName': 'Edouard G', 'Initials': 'EG', 'LastName': 'Mills', 'Affiliation': 'Division of Diabetes, Endocrinology and Metabolism, Imperial College London, London, UK.'}, {'ForeName': 'Victoria C', 'Initials': 'VC', 'LastName': 'Wing', 'Affiliation': 'Division of Diabetes, Endocrinology and Metabolism, Imperial College London, London, UK.'}, {'ForeName': 'Layla', 'Initials': 'L', 'LastName': 'Thurston', 'Affiliation': 'Division of Diabetes, Endocrinology and Metabolism, Imperial College London, London, UK.'}, {'ForeName': 'Caroline N', 'Initials': 'CN', 'LastName': 'Schaufelberger', 'Affiliation': 'Invicro London, UK.'}, {'ForeName': 'Bryn M', 'Initials': 'BM', 'LastName': 'Owen', 'Affiliation': 'Division of Diabetes, Endocrinology and Metabolism, Imperial College London, London, UK.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Abbara', 'Affiliation': 'Division of Diabetes, Endocrinology and Metabolism, Imperial College London, London, UK.'}, {'ForeName': 'Eugenii A', 'Initials': 'EA', 'LastName': 'Rabiner', 'Affiliation': 'Invicro London, UK.'}, {'ForeName': 'Alexander N', 'Initials': 'AN', 'LastName': 'Comninos', 'Affiliation': 'Division of Diabetes, Endocrinology and Metabolism, Imperial College London, London, UK.'}, {'ForeName': 'Waljit S', 'Initials': 'WS', 'LastName': 'Dhillo', 'Affiliation': 'Division of Diabetes, Endocrinology and Metabolism, Imperial College London, London, UK.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa746']
1609,33075842,A Model to Predict Vaginal Delivery and Maternal and Neonatal Morbidity in Low-Risk Nulliparous Patients at Term.,"OBJECTIVE


This study aimed to develop and validate a model to predict the probability of vaginal delivery (VD) in low-risk term nulliparous patients, and to determine whether it can predict the risk of severe maternal and neonatal morbidity.
METHODS


Secondary analysis of an obstetric cohort of patients and their neonates born in 25 hospitals across the United States ( n  = 115,502). Trained and certified research personnel abstracted the maternal and neonatal records. Nulliparous patients with singleton, nonanomalous vertex fetuses, admitted with an intent for VD ≥ 37 weeks were included in this analysis. Patients in active labor (cervical exam > 5 cm), those with prior cesarean and other comorbidities were excluded. Eligible patients were randomly divided into a training and test sets. Based on the training set, and using factors available at the time of admission for delivery, we developed and validated a logistic regression model to predict the probability of VD, and then estimated the prevalences of severe morbidity according to the predicted probability of VD.
RESULTS


A total of 19,611 patients were included. Based on the training set ( n  = 9,739), a logistic regression model was developed that included maternal age, body mass index (BMI), cervical dilatation, and gestational age on admission. The model was internally validated on the test set ( n  = 9,872 patients) and yielded a receiver operating characteristic-area under the curve (ROC-AUC) of 0.71 (95% confidence interval [CI]: 0.70-0.72). Based on a subset of 18,803 patients with calculated predicted probabilities, we demonstrated that the prevalences of severe morbidity decreased as the predicted probability of VD increased ( p  < 0.01).
CONCLUSION


In a large cohort of low-risk nulliparous patients in early labor or undergoing induction of labor, at term with singleton gestations, we developed and validated a model to calculate the probability of VD, and maternal and neonatal morbidity. If externally validated, this calculator may be clinically useful in helping to direct level of care, staffing, and adjustment for case-mix among various systems.
KEY POINTS


· A model to predict the probability of vaginal delivery in low-risk nulliparous patients at term.. · The model also predicts the risk of severe maternal and neonatal morbidity.. · The prevalences of severe morbidity decrease as the probability of vaginal delivery increases..",2020,"The model was internally validated on the test set ( n  = 9,872 patients) and yielded a receiver operating characteristic-area under the curve (ROC-AUC) of 0.71 (95% confidence interval [CI]: 0.70-0.72).","['low-risk term nulliparous patients', 'Nulliparous patients with singleton, nonanomalous vertex fetuses, admitted with an intent for VD\u2009≥\u200937 weeks', 'Eligible patients', 'Patients in active labor (cervical exam\u2009>\u20095\u2009cm), those with prior cesarean and other comorbidities were excluded', 'low-risk nulliparous patients at term.. ·', 'A total of 19,611 patients were included', 'Secondary analysis of an obstetric cohort of patients and their neonates born in 25 hospitals across the United States ( n \u2009=\u2009115,502', 'Low-Risk Nulliparous Patients at Term', 'low-risk nulliparous patients in early labor or undergoing induction of labor, at term with singleton gestations']",[],"['Vaginal Delivery and Maternal and Neonatal Morbidity', 'probability of vaginal delivery', 'probability of vaginal delivery (VD', 'probability of VD, and maternal and neonatal morbidity', 'probability of VD', 'severe morbidity']","[{'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0425979', 'cui_str': 'Nulliparous'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0230003', 'cui_str': 'Vertex structure'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0566690', 'cui_str': 'Vaginal delivery'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0233081', 'cui_str': 'Normal labor'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0582103', 'cui_str': 'Medical assessment'}, {'cui': 'C0439084', 'cui_str': '>5'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0022876', 'cui_str': 'Premature labor'}, {'cui': 'C0259787', 'cui_str': 'Induction of labor'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]",[],"[{'cui': 'C0566690', 'cui_str': 'Vaginal delivery'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",19611.0,0.0573934,"The model was internally validated on the test set ( n  = 9,872 patients) and yielded a receiver operating characteristic-area under the curve (ROC-AUC) of 0.71 (95% confidence interval [CI]: 0.70-0.72).","[{'ForeName': 'Maged M', 'Initials': 'MM', 'LastName': 'Costantine', 'Affiliation': 'Departments of Obstetrics and Gynecology of University of Texas Medical Branch, Galveston, Texas.'}, {'ForeName': 'Grecio', 'Initials': 'G', 'LastName': 'Sandoval', 'Affiliation': 'The George Washington University Biostatistics Center, Washington, Dist. of Columbia.'}, {'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Grobman', 'Affiliation': 'Department of Obstetrics and Gynecology, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Bailit', 'Affiliation': 'Department of Obstetrics and Gynecology, MetroHealth Medical Center-Case Western Reserve University, Cleveland, Ohio.'}, {'ForeName': 'Uma M', 'Initials': 'UM', 'LastName': 'Reddy', 'Affiliation': 'Department of Obstetrics and Gynecology, The Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.'}, {'ForeName': 'Ronald J', 'Initials': 'RJ', 'LastName': 'Wapner', 'Affiliation': 'Department of Obstetrics and Gynecology, Columbia University, New York, New York.'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Varner', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Utah Health Sciences Center, Salt Lake City, Utah.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Thorp', 'Affiliation': 'Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Steve N', 'Initials': 'SN', 'LastName': 'Caritis', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Prasad', 'Affiliation': 'Department of Obstetrics and Gynecology, The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Alan T N', 'Initials': 'ATN', 'LastName': 'Tita', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Yoram', 'Initials': 'Y', 'LastName': 'Sorokin', 'Affiliation': 'Department of Obstetrics and Gynecology, Wayne State University, Detroit, Michigan.'}, {'ForeName': 'Dwight J', 'Initials': 'DJ', 'LastName': 'Rouse', 'Affiliation': 'Department of Obstetrics and Gynecology, Brown University, Providence, Rhode Island.'}, {'ForeName': 'Sean C', 'Initials': 'SC', 'LastName': 'Blackwell', 'Affiliation': ""Department of Obstetrics and Gynecology, The University of Texas Health Science Center at Houston, McGovern Medical School-Children's Memorial Hermann Hospital, Houston, Texas.""}, {'ForeName': 'Jorge E', 'Initials': 'JE', 'LastName': 'Tolosa', 'Affiliation': 'Department of Obstetrics and Gynecology, Oregon Health and Science University, Portland, Oregon.'}]",American journal of perinatology,['10.1055/s-0040-1718704']
1610,33075844,The Safety of Low-Dose Aspirin on the Mode of Delivery: Secondary Analysis of the Effect of Aspirin in Gestation and Reproduction Randomized Controlled Trial.,"OBJECTIVE


This study aimed to examine whether prenatal low-dose aspirin (LDA) therapy affects risk of cesarean versus vaginal delivery.
STUDY DESIGN


This study is a secondary analysis of the randomized clinical effects of aspirin in gestation and reproduction (EAGeR) trial. Women received 81-mg daily aspirin or placebo from preconception to 36 weeks of gestation. Mode of delivery and obstetric complications were abstracted from records. Log-binomial regression models estimated relative risk (RR) of cesarean versus vaginal delivery. Data were analyzed among the total preconception cohort, as well as restricted to women who had a live birth.
RESULTS


Among 1,228 women, 597 had a live birth. In the intent-to-treat analysis, preconception-initiated LDA was not associated with risk of cesarean (RR = 1.02; 95% confidence interval [CI]: 0.98-1.07) compared with placebo. Findings were similar in just women with a live birth and when accounting prior cesarean delivery and parity.
CONCLUSION


Preconception-initiated daily LDA was not associated with mode of delivery among women with one to two prior losses.
KEY POINTS


· Aspirin was not associated with risk of cesarean section.. · Aspirin was not associated with mode of delivery.. · No increased risk of bleeding with use of aspirin..",2020,Aspirin was not associated with risk of cesarean section.. ·,"['1,228 women, 597 had a live birth', 'women who had a live birth']","['prenatal low-dose aspirin (LDA) therapy', 'Preconception-initiated daily LDA', 'aspirin or placebo', 'Low-Dose Aspirin', 'Aspirin', 'placebo', 'aspirin']","['risk of bleeding', 'risk of cesarean']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}]","[{'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",1228.0,0.331762,Aspirin was not associated with risk of cesarean section.. ·,"[{'ForeName': 'Allison A', 'Initials': 'AA', 'LastName': 'Eubanks', 'Affiliation': 'Department of Obstetrics and Gynecology, Walter Reed National Military Medical Center, Bethesda, Maryland.'}, {'ForeName': 'Carrie J', 'Initials': 'CJ', 'LastName': 'Nobles', 'Affiliation': 'Division of Intramural Population Health Research, Epidemiology Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.'}, {'ForeName': 'Sunni L', 'Initials': 'SL', 'LastName': 'Mumford', 'Affiliation': 'Division of Intramural Population Health Research, Epidemiology Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.'}, {'ForeName': 'Keewan', 'Initials': 'K', 'LastName': 'Kim', 'Affiliation': 'Division of Intramural Population Health Research, Epidemiology Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.'}, {'ForeName': 'Micah J', 'Initials': 'MJ', 'LastName': 'Hill', 'Affiliation': 'Reproductive and Adult Endocrinology, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Alan H', 'Initials': 'AH', 'LastName': 'Decherney', 'Affiliation': 'Reproductive and Adult Endocrinology, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Lindsey A', 'Initials': 'LA', 'LastName': 'Sjaarda', 'Affiliation': 'Division of Intramural Population Health Research, Epidemiology Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.'}, {'ForeName': 'Aijun', 'Initials': 'A', 'LastName': 'Ye', 'Affiliation': 'Glotech, Inc., Rockville, Maryland.'}, {'ForeName': 'Jeannie G', 'Initials': 'JG', 'LastName': 'Radoc', 'Affiliation': 'Division of Intramural Population Health Research, Epidemiology Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.'}, {'ForeName': 'Neil J', 'Initials': 'NJ', 'LastName': 'Perkins', 'Affiliation': 'Division of Intramural Population Health Research, Epidemiology Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Silver', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Utah Health Sciences Center, Salt Lake City, Utah.'}, {'ForeName': 'Enrique F', 'Initials': 'EF', 'LastName': 'Schisterman', 'Affiliation': 'Division of Intramural Population Health Research, Epidemiology Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.'}]",American journal of perinatology,['10.1055/s-0040-1718581']
1611,32801696,Development and Characterization of A New Dimethicone Nanoemulsion and its Application for Electronic Gastroscopy Examination.,"Purpose


Although the effective and safe medical defoamers, dimethicone (DM) and simethicone (SM) are widely used in electronic gastroscope examination (EGE), their preparations are presented in the form of suspensions or emulsions, these are untransparent or milk-like in appearance and can easily cause misdiagnosis as a result of an unclear field of vision if the doctor does not master the amount of defoamer or operates incorrectly. At the same time, it is also difficult to wash out the camera and pipeline, due to the large oil droplets of preparations. The purpose of this study was to develop a new clear and transparent oil in water (O/W) DM nanoemulsions (DMNs) and observe the effect of application in EGE.
Methods


The oil phase was chosen for its antifoaming activity and viscosity. The emulsifier and co-emulsifier were selected according to the solubility of the oil phase in them. The water titration method was used to make the pseudoternary phase diagrams of nanoemulsions and optimize the prescription composition. DM-in-water nanoemulsion was prepared by the low energy method and evaluated for appearance, antifoaming ability, droplet size, and stability. The effect of DMNs utilized in EGEs was also observed.
Results


The optimal formulation of DMNs contained CRH-40 as an emulsifier, PEG-400 as a co-emulsifier, DM as oil phase with the viscosity of 10 mPa.s, and their proportion was 4.5:4.5:1, respectively. DMNs obtained the average particle size of 67.98 nm with the polydispersity index (PDI) of 0.332, and 57.14% defoaming rate. The result of using an EGE showed that DMNs were superior in comparison to the emulsions with regard to the defoaming effect, visual clarity, and easy cleanup.
Conclusion


DMNs were found to provide excellent visual clarity to its other preparations. The novel DMNs is a promising substitute for DM emulsions or suspensions in EGEs.",2020,"The result of using an EGE showed that DMNs were superior in comparison to the emulsions with regard to the defoaming effect, visual clarity, and easy cleanup.
",[],"['dimethicone (DM) and simethicone (SM', 'transparent oil in water (O/W) DM nanoemulsions (DMNs']",[],[],"[{'cui': 'C0721771', 'cui_str': 'Moisturel'}, {'cui': 'C0037138', 'cui_str': 'Simethicone'}, {'cui': 'C0522503', 'cui_str': 'Translucent'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}]",[],,0.0145137,"The result of using an EGE showed that DMNs were superior in comparison to the emulsions with regard to the defoaming effect, visual clarity, and easy cleanup.
","[{'ForeName': 'Suo-Min', 'Initials': 'SM', 'LastName': 'Feng', 'Affiliation': ""Shaanxi Key Laboratory of Ischemic Cardiovascular Disease, Xi'an Medical University, Xi'an 710021, People's Republic of China.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': ""School of Life Science and Biopharmaceutics, Shenyang Pharmaceutical University, Shenyang 110016, People's Republic of China.""}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Xu', 'Affiliation': ""College of Life Sciences, Northwest University, Xi'an 710069, People's Republic of China.""}, {'ForeName': 'Hui-Min', 'Initials': 'HM', 'LastName': 'Li', 'Affiliation': ""Public Course Teaching Department, Shangluo Vocational and Technical College, Shangzhou, 726000, People's Republic of China.""}, {'ForeName': 'Yu-Xiu', 'Initials': 'YX', 'LastName': 'Huang', 'Affiliation': ""Department of English, Xi'an Medical University, Xi'an 710021, People's Republic of China.""}, {'ForeName': 'Huan-Huan', 'Initials': 'HH', 'LastName': 'Liu', 'Affiliation': ""Shaanxi Key Laboratory of Ischemic Cardiovascular Disease, Xi'an Medical University, Xi'an 710021, People's Republic of China.""}, {'ForeName': 'Cang-Bao', 'Initials': 'CB', 'LastName': 'Xu', 'Affiliation': ""Shaanxi Key Laboratory of Ischemic Cardiovascular Disease, Xi'an Medical University, Xi'an 710021, People's Republic of China.""}]",International journal of nanomedicine,['10.2147/IJN.S251113']
1612,33076217,Long Term Dietary Restriction of Advanced Glycation End-Products (AGEs) in Older Adults with Type 2 Diabetes Is Feasible and Efficacious-Results from a Pilot RCT.,"INTRODUCTION


High serum concentrations of advanced glycation end-products (AGEs) in older adults and diabetics are associated with an increased risk of cognitive impairment. The aim of this pilot study was to assess the feasibility of long-term adherence to a dietary intervention designed to decrease intake and exposure to circulating AGEs among older adults with type 2 diabetes.
METHODS


Herein, 75 participants were randomized to either a standard of care (SOC) control arm or to an intervention arm receiving instruction on reducing dietary AGEs intake. The primary outcome was a change in serum AGEs at the end of the intervention. Secondary and exploratory outcomes included adherence to diet and its association with circulating AGEs. Cognitive function and brain imaging were also assessed but were out of the scope of this article (ClinicalTrials.gov Identifier: NCT02739971).
RESULTS


The intervention resulted in a significant change over time in several serum AGEs compared to the SOC guidelines. Very high adherence (above 80%) to the AGE-lowering diet was associated with a greater reduction in serum AGEs levels. There were no significant differences between the two arms in any other metabolic markers.
CONCLUSIONS


A long-term dietary intervention to reduce circulating AGEs is feasible in older adults with type 2 diabetes, especially in those who are highly adherent to the AGE-lowering diet.",2020,Very high adherence (above 80%) to the AGE-lowering diet was associated with a greater reduction in serum AGEs levels.,"['Herein, 75 participants', 'older adults and diabetics', 'older adults with type 2 diabetes', 'Older Adults with Type 2 Diabetes']","['standard of care (SOC) control arm or to an intervention arm receiving instruction on reducing dietary AGEs intake', 'dietary intervention', 'Advanced Glycation End-Products (AGEs']","['change in serum AGEs', 'time in several serum AGEs', 'Cognitive function and brain imaging', 'adherence to diet and its association with circulating AGEs', 'serum AGEs levels']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0162574', 'cui_str': 'Advanced Glycation End Products'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0162574', 'cui_str': 'Advanced Glycation End Products'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0203860', 'cui_str': 'Imaging of brain'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",75.0,0.0412427,Very high adherence (above 80%) to the AGE-lowering diet was associated with a greater reduction in serum AGEs levels.,"[{'ForeName': 'Roni', 'Initials': 'R', 'LastName': 'Lotan', 'Affiliation': 'The Nutrition and Brain Health Laboratory, The Institute of Biochemistry, Food and Nutrition Science, The Robert H. Smith Faculty of Agriculture Food and the Environment, The Hebrew University of Jerusalem, 7610001 Rehovot, Israel.'}, {'ForeName': 'Ithamar', 'Initials': 'I', 'LastName': 'Ganmore', 'Affiliation': 'The Joseph Sagol Neuroscience Center, Sheba Medical Center, 5265601 Tel Hashomer, Israel.'}, {'ForeName': 'Shahar', 'Initials': 'S', 'LastName': 'Shelly', 'Affiliation': 'The Joseph Sagol Neuroscience Center, Sheba Medical Center, 5265601 Tel Hashomer, Israel.'}, {'ForeName': 'Moran', 'Initials': 'M', 'LastName': 'Zacharia', 'Affiliation': 'The Joseph Sagol Neuroscience Center, Sheba Medical Center, 5265601 Tel Hashomer, Israel.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Uribarri', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY 10029, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Beisswenger', 'Affiliation': 'PreventAGE Healthcare, Lebanon, NH 03766, USA.'}, {'ForeName': 'Weijing', 'Initials': 'W', 'LastName': 'Cai', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY 10029, USA.'}, {'ForeName': 'Aron M', 'Initials': 'AM', 'LastName': 'Troen', 'Affiliation': 'The Nutrition and Brain Health Laboratory, The Institute of Biochemistry, Food and Nutrition Science, The Robert H. Smith Faculty of Agriculture Food and the Environment, The Hebrew University of Jerusalem, 7610001 Rehovot, Israel.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Schnaider Beeri', 'Affiliation': 'The Joseph Sagol Neuroscience Center, Sheba Medical Center, 5265601 Tel Hashomer, Israel.'}]",Nutrients,['10.3390/nu12103143']
1613,33076229,"A Randomized Controlled Trial Testing the Effectiveness of Coping with Cancer in the Kitchen, a Nutrition Education Program for Cancer Survivors.","Following a diet rich in whole grains, vegetables, fruit, and beans may reduce cancer incidence and mortality. The aim of this study was to investigate the effect of Coping with Cancer in the Kitchen (CCK), an 8 week in-person program offering education, culinary demonstrations and food tasting, and psychosocial group support, compared to receiving CCK printed materials by mail on knowledge, confidence, and skills in implementing a plant-based diet. A total of 54 adult cancer survivors were randomly assigned to intervention ( n  = 26) and control groups ( n  = 27) with assessments at baseline, 9, and 15 weeks via self-administered survey. The response rate was 91% at 9 weeks and 58% at 15 weeks. The majority of our study participants were female breast cancer survivors (58%) who had overweight or obesity (65%). Compared with the control, there were significant ( p  < 0.05) increases in intervention participants' knowledge about a plant-based diet at weeks 9 and 15, reductions in perceived barriers to eating more fruits and vegetables at week 9, and enhanced confidence and skills in preparing a plant-based diet at week 15. There was a significant reduction in processed meat intake but changes in other food groups and psychosocial measures were modest. Participation in CCK in person increased knowledge, skills, and confidence and reduced barriers to adopting a plant-based diet. Positive trends in intake of plant-based foods and quality of life warrant further investigation in larger-scale studies and diverse populations.",2020,"Compared with the control, there were significant ( p  < 0.05) increases in intervention participants' knowledge about a plant-based diet at weeks 9 and 15, reductions in perceived barriers to eating more fruits and vegetables at week 9, and enhanced confidence and skills in preparing a plant-based diet at week 15.","['Cancer Survivors', 'participants were female breast cancer survivors (58%) who had overweight or obesity (65', '54 adult cancer survivors']",['Coping with Cancer in the Kitchen (CCK'],"['processed meat intake', 'response rate', 'cancer incidence and mortality']","[{'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0235653', 'cui_str': 'Malignant neoplasm of female breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0557653', 'cui_str': 'Kitchen'}]","[{'cui': 'C0556213', 'cui_str': 'Processed meat intake'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",54.0,0.0413395,"Compared with the control, there were significant ( p  < 0.05) increases in intervention participants' knowledge about a plant-based diet at weeks 9 and 15, reductions in perceived barriers to eating more fruits and vegetables at week 9, and enhanced confidence and skills in preparing a plant-based diet at week 15.","[{'ForeName': 'Melissa Farmer', 'Initials': 'MF', 'LastName': 'Miller', 'Affiliation': 'Department of Public Health, College of Health Sciences, Arcadia University, Glenside, PA 19038, USA.'}, {'ForeName': 'Zhongyu', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health, Baltimore, MD 21205, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Habedank', 'Affiliation': 'American Institute for Cancer Research, Arlington, VA 22209, USA.'}]",Nutrients,['10.3390/nu12103144']
1614,33076263,Carbohydrate-Induced Insulin Signaling Activates Focal Adhesion Kinase: A Nutrient and Mechanotransduction Crossroads.,"Research has suggested that nutrient, exercise, and metabolism-related proteins interact to regulate mammalian target of rapamycin complex one (mTOR) post-exercise and their interactions needs clarification. In a double-blind, cross-over, repeated measures design, ten participants completed four sets to failure at 70% of 1-repitition maximum (1-RM) with 45 s rest on angled leg press with or without pre-exercise maltodextrin (2 g/kg) after a 3 h fast. Vastus lateralis biopsies were collected at baseline before supplementation and 1 h post-exercise to analyze Focal Adhesion Kinase (FAK), ribosomal protein S6 kinase beta-1 (p70S6K), insulin receptor substrate 1 (IRS-1), phosphatidylinositol 3-kinase (PI3K), and 5' AMP-activated protein kinase (AMPK) activation. FAK and IRS-1 activity were only elevated 1 h post-exercise with carbohydrate ingestion ( p  < 0.05). PI3K and p70S6K activation were both elevated after exercise in both conditions ( p  < 0.05). However, AMPK activity did not change from baseline in both conditions ( p  > 0.05). We conclude that FAK does not induce mTOR activation through PI3K crosstalk in response to exercise alone. In addition, FAK may not be regulated by AMPK catalytic activity, but this needs further research. Interestingly, carbohydrate-induced insulin signaling appears to activate FAK at the level of IRS-1 but did not enhance mTOR activity 1 h post-exercise greater than the placebo condition. Future research should investigate these interactions under different conditions and within different time frames to clearly understand the interactions between these signaling molecules.",2020,FAK and IRS-1 activity were only elevated 1 h post-exercise with carbohydrate ingestion ( p  < 0.05).,[],"['FAK', 'Carbohydrate-Induced Insulin Signaling Activates Focal Adhesion Kinase', '1-repitition maximum (1-RM) with 45 s rest on angled leg press with or without pre-exercise maltodextrin']","['AMPK activity', 'mTOR activity', 'PI3K and p70S6K activation', 'Focal Adhesion Kinase (FAK), ribosomal protein S6 kinase beta-1 (p70S6K), insulin receptor substrate 1 (IRS-1), phosphatidylinositol 3-kinase', ""PI3K), and 5' AMP-activated protein kinase (AMPK) activation"", 'FAK and IRS-1 activity']",[],"[{'cui': 'C0059239', 'cui_str': 'Endogenous Substrate pp120'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}]","[{'cui': 'C2350345', 'cui_str': 'AMP-Activated Protein Kinase'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0293060', 'cui_str': 'FKBP12-Rapamycin Associated Protein'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0044602', 'cui_str': '1-phosphatidylinositol 3-kinase'}, {'cui': 'C1136240', 'cui_str': 'p70 S6 Kinase'}, {'cui': 'C0059239', 'cui_str': 'Endogenous Substrate pp120'}, {'cui': 'C2827383', 'cui_str': 'ribosomal protein S6 kinase beta 1'}, {'cui': 'C0123658', 'cui_str': 'Insulin Receptor Substrate-1'}]",10.0,0.113269,FAK and IRS-1 activity were only elevated 1 h post-exercise with carbohydrate ingestion ( p  < 0.05).,"[{'ForeName': 'Dylan T', 'Initials': 'DT', 'LastName': 'Wilburn', 'Affiliation': 'Exercise and Biochemical Nutrition Laboratory, Department of Health, Human Performance, and Recreation, Baylor University, Waco, TX 76706, USA.'}, {'ForeName': 'Steven B', 'Initials': 'SB', 'LastName': 'Machek', 'Affiliation': 'Exercise and Biochemical Nutrition Laboratory, Department of Health, Human Performance, and Recreation, Baylor University, Waco, TX 76706, USA.'}, {'ForeName': 'Thomas D', 'Initials': 'TD', 'LastName': 'Cardaci', 'Affiliation': 'Exercise and Biochemical Nutrition Laboratory, Department of Health, Human Performance, and Recreation, Baylor University, Waco, TX 76706, USA.'}, {'ForeName': 'Darryn S', 'Initials': 'DS', 'LastName': 'Willoughby', 'Affiliation': 'Exercise and Biochemical Nutrition Laboratory, Department of Health, Human Performance, and Recreation, Baylor University, Waco, TX 76706, USA.'}]",Nutrients,['10.3390/nu12103145']
1615,32686744,The impact of vitamin D supplementation on VDR gene expression and body composition in monozygotic twins: randomized controlled trial.,"Vitamin D supplementation is widely used. However, there is no consensus on the use and dosage of this supplement and the existing recommendations arise from studies based on the benefits that this nutrient can facilitate in bones. In addition, individual genetics can influence the response to supplementation, therefore, research involving monozygotic twins aims to reduce these differences in phenotypic responses. The objective of this randomised controlled study is to examine the effect of vitamin D supplementation on body composition and the expression of the vitamin D receptor (VDR) mRNA. An intervention was performed through supplementation with cholecalciferol at the concentration of 2000 IU in 90 healthy adult monozygotic twins (male or female pairs) for 2 months. The findings showed that serum vitamin D concentration increased by 65% and VDR gene expression sixty times (p = 0.001). Changes in body composition parameters were observed regarding body fat and lean mass. Our results indicate that an increase in serum vitamin D concentration may have potential therapeutic implications.",2020,The findings showed that serum vitamin D concentration increased by 65% and VDR gene expression sixty times (p = 0.001).,"['monozygotic twins', '90 healthy adult monozygotic twins (male or female pairs) for 2\xa0months']","['cholecalciferol', 'vitamin D supplementation', 'Vitamin D supplementation']","['body composition and the expression of the vitamin D receptor (VDR) mRNA', 'VDR gene expression and body composition', 'serum vitamin D concentration', 'body composition parameters']","[{'cui': 'C0041432', 'cui_str': 'Monozygotic twins'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0108082', 'cui_str': 'Vitamin D3 Receptor'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0428586', 'cui_str': 'Serum vitamin D measurement'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",90.0,0.199654,The findings showed that serum vitamin D concentration increased by 65% and VDR gene expression sixty times (p = 0.001).,"[{'ForeName': 'Jeane Franco Pires', 'Initials': 'JFP', 'LastName': 'Medeiros', 'Affiliation': 'Department of Health Sciences, Federal University of Rio Grande Do Norte, Av. General Cordeiro de Farias, S/N - Petrópolis, Natal, RN, 59012-570, Brazil. jeanefpires@hotmail.com.'}, {'ForeName': 'Michelle Vasconcelos', 'Initials': 'MV', 'LastName': 'de Oliveira Borges', 'Affiliation': 'Department of Health Sciences, Federal University of Rio Grande Do Norte, Av. General Cordeiro de Farias, S/N - Petrópolis, Natal, RN, 59012-570, Brazil.'}, {'ForeName': 'Aline Alves', 'Initials': 'AA', 'LastName': 'Soares', 'Affiliation': 'Department of Health Sciences, Federal University of Rio Grande Do Norte, Av. General Cordeiro de Farias, S/N - Petrópolis, Natal, RN, 59012-570, Brazil.'}, {'ForeName': 'Jessica Cavalcante', 'Initials': 'JC', 'LastName': 'Dos Santos', 'Affiliation': 'Department of Pharmaceutical Sciences, Faculty of Pharmacy, Federal University of Rio Grande Do Norte, Natal, RN, Brazil.'}, {'ForeName': 'Ana Beatriz Bezerra', 'Initials': 'ABB', 'LastName': 'de Oliveira', 'Affiliation': 'Department of Pharmaceutical Sciences, Faculty of Pharmacy, Federal University of Rio Grande Do Norte, Natal, RN, Brazil.'}, {'ForeName': 'Conceição Horrana Belo', 'Initials': 'CHB', 'LastName': 'da Costa', 'Affiliation': 'Department of Pharmaceutical Sciences, Faculty of Pharmacy, Federal University of Rio Grande Do Norte, Natal, RN, Brazil.'}, {'ForeName': 'Marina Sampaio', 'Initials': 'MS', 'LastName': 'Cruz', 'Affiliation': 'Department of Health Sciences, Federal University of Rio Grande Do Norte, Av. General Cordeiro de Farias, S/N - Petrópolis, Natal, RN, 59012-570, Brazil.'}, {'ForeName': 'Raul Hernandes', 'Initials': 'RH', 'LastName': 'Bortolin', 'Affiliation': 'Department of Clinical and Toxicological Analyses, School of Pharmaceutical Sciences, University of Sao Paulo, Sao Paulo, SP, Brazil.'}, {'ForeName': 'Renata Caroline Costa', 'Initials': 'RCC', 'LastName': 'de Freitas', 'Affiliation': 'Department of Clinical and Toxicological Analyses, School of Pharmaceutical Sciences, University of Sao Paulo, Sao Paulo, SP, Brazil.'}, {'ForeName': 'Paulo Moreira Silva', 'Initials': 'PMS', 'LastName': 'Dantas', 'Affiliation': 'Department of Health Sciences, Federal University of Rio Grande Do Norte, Av. General Cordeiro de Farias, S/N - Petrópolis, Natal, RN, 59012-570, Brazil.'}, {'ForeName': 'Mario Hiroyuki', 'Initials': 'MH', 'LastName': 'Hirata', 'Affiliation': 'Department of Clinical and Toxicological Analyses, School of Pharmaceutical Sciences, University of Sao Paulo, Sao Paulo, SP, Brazil.'}, {'ForeName': 'Vivian Nogueira', 'Initials': 'VN', 'LastName': 'Silbiger', 'Affiliation': 'Graduate Program in Pharmaceutical Sciences, Faculty of Pharmacy, Federal University of Rio Grande Do Norte, Natal, RN, Brazil.'}, {'ForeName': 'André Ducati', 'Initials': 'AD', 'LastName': 'Luchessi', 'Affiliation': 'Department of Health Sciences, Federal University of Rio Grande Do Norte, Av. General Cordeiro de Farias, S/N - Petrópolis, Natal, RN, 59012-570, Brazil.'}]",Scientific reports,['10.1038/s41598-020-69128-2']
1616,33065817,Utilizing placebos to leverage effects of cognitive-behavioral therapy in patients with depression.,"BACKGROUND


Patients with depression often experience difficulties with completing homework assignments during cognitive-behavioral therapy (CBT). In the present study, we investigated the effects of a specific placebo which aimed at improving the practice of a daily relaxation exercise during a four-week outpatient program.
METHODS


A total of 126 patients diagnosed with major depressive disorder were randomly assigned to one of three groups: 'Coping with Depression' course, 'Coping with Depression' course with additional daily placebo treatment, and waiting-list group. The placebo (sunflower oil) was introduced as a natural medicine to help the patients focus on their inner strengths and to mobilize their bodies' natural healing powers. The placebo was taken orally before the daily relaxation exercise.
RESULTS


The placebo improved homework quantity and quality (both p < .001). The placebo group practiced more often and experienced greater relaxation effects than the no-placebo group. Additionally, the placebo group showed a greater reduction of depression symptoms (p < .001).
LIMITATIONS


The primary limitation of the study is the lack of a psychophysiological measure of relaxation.
CONCLUSIONS


Placebos can be used to leverage CBT effects in patients with depression.",2020,The placebo improved homework quantity and quality (both p < .001).,"['patients with depression', '126 patients diagnosed with major depressive disorder']","['cognitive-behavioral therapy (CBT', 'specific placebo', 'placebo', 'cognitive-behavioral therapy', 'Placebos', ""Coping with Depression' course, 'Coping with Depression' course with additional daily placebo treatment, and waiting-list group"", 'placebo (sunflower oil']","['reduction of depression symptoms', 'leverage CBT effects', 'relaxation effects', 'homework quantity and quality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0947381', 'cui_str': 'Helianthus annuus'}, {'cui': 'C0028908', 'cui_str': 'Oil'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0589414', 'cui_str': 'Homework'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0332306', 'cui_str': 'Quality'}]",126.0,0.205786,The placebo improved homework quantity and quality (both p < .001).,"[{'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Jurinec', 'Affiliation': 'University of Graz, Department of Clinical Psychology, Graz, Austria; Community Health Center Gornja Radgona, Gornja Radgona, Slovenia.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Schienle', 'Affiliation': 'University of Graz, Department of Clinical Psychology, Graz, Austria. Electronic address: anne.schienle@uni-graz.at.'}]",Journal of affective disorders,['10.1016/j.jad.2020.08.087']
1617,33065818,Differential effects of cranial electrotherapy stimulation on changes in anxiety and depression symptoms over time in patients with generalized anxiety disorder.,"BACKGROUND


Cranial electrotherapy stimulation (CES) is a safe and well-tolerated 6-12 week treatment that is clinically and cost effective on both anxiety and depression symptoms resulting in sustained remission of these symptoms at 12 and 24 weeks in generalized anxiety disorder (GAD) patients. The aim of the current report was to explore whether the effectiveness of CES was related to its effects on depression or anxiety over time METHODS: A consecutive sample of 161 eligible patients with GAD was recruited from two publicly funded services in England while they waited for individual cognitive behaviour therapy (CBT) after failing to achieve remission on the GAD-7 with computerised CBT. They received 60 minutes per day Alpha-Stim CES for 6-12 weeks. Outcomes were changes in PHQ-9, GAD-7 score from baseline to 4, 6, 8, 12 and 24 weeks. Latent variable cross-lagged panel analysis permitted an analysis of the differential effects of anxiety and depression with CES treatment over time.
RESULTS


Anxiety at baseline significantly predicted depression at week 4 (standardized regression weight = .40, p<0.001). Depression at week 12 significantly predicted anxiety at week 24 (standardized regression weight = .28, p<0.05).
LIMITATIONS


Not a randomized controlled trial but further analysis of a prospective observational cohort. High rates of loss to follow up by 24 weeks.
CONCLUSION


Sustained effectiveness required a CES response to anxiety symptoms in first 4 weeks and improvement in depression symptoms by 12 weeks.",2020,"Depression at week 12 significantly predicted anxiety at week 24 (standardized regression weight = .28, p<0.05).
","['patients with generalized anxiety disorder', ' A consecutive sample of 161 eligible patients with GAD was recruited from two publicly funded services in England while they waited for individual cognitive behaviour therapy (CBT) after failing to achieve remission on the GAD-7 with computerised CBT']","['CES', 'cranial electrotherapy stimulation', 'Cranial electrotherapy stimulation (CES']","['Depression', 'anxiety', 'PHQ-9, GAD-7 score', 'depression symptoms', 'anxiety and depression symptoms', 'CES response to anxiety symptoms', 'depression or anxiety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0016820', 'cui_str': 'Funds'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0542399', 'cui_str': 'Patient waiting for'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0037303', 'cui_str': 'Bone structure of cranium'}, {'cui': 'C0013787', 'cui_str': 'Electrotherapy'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0037303', 'cui_str': 'Bone structure of cranium'}, {'cui': 'C0013787', 'cui_str': 'Electrotherapy'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}]",161.0,0.0584754,"Depression at week 12 significantly predicted anxiety at week 24 (standardized regression weight = .28, p<0.05).
","[{'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Morriss', 'Affiliation': 'Professor of Psychiatry, Institute of Mental Health and NIHR MindTech MTEC, University of Nottingham, Triumph Road, Nottingham, NG7 2TU, United Kingdom. Electronic address: richard.morriss@nottingham.ac.uk.'}, {'ForeName': 'Larry', 'Initials': 'L', 'LastName': 'Price', 'Affiliation': 'Professor/Director Methodology, Measurement and Statistical Analysis, Texas State University, Texas, US.'}]",Journal of affective disorders,['10.1016/j.jad.2020.09.006']
1618,33065820,Cognitive behavioral social rhythm group therapy versus present centered group therapy for veterans with posttraumatic stress disorder and major depressive disorder: A randomized controlled pilot trial.,"BACKGROUND


Cognitive Behavioral Social Rhythm Group Therapy (CBSRT) is a chronobiologically-informed group therapy designed to stabilize social rhythms in veterans with comorbid combat-related PTSD and major depressive disorder (MDD). This randomized controlled pilot trial is the first to examine feasibility and preliminary efficacy of group CBSRT as compared to group Present Centered Therapy (PCT), a well-characterized active attention, psychotherapy condition.
METHODS


A total of 43 male veterans with combat-related PTSD, MDD, and disruptions in sleep or daily routine were randomly assigned to CBSRT or PCT. Therapy was provided weekly in a group modality for 12 weeks. Follow-up feasibility and gold-standard PTSD, MDD, and subjective/objective sleep assessments were conducted at post-treatment, 3 months, and 6 months post-treatment.
RESULTS


Feasibility results demonstrated that veterans assigned to CBSRT had higher rates of attendance than veterans assigned to PCT. Both CBSRT and PCT were associated with improvements in PTSD and MDD symptoms, sleep efficiency, and number of awakenings; there were no differences between group therapies on these indices. Veterans in the CBSRT group had a greater reduction in the number of nightmares than veterans in the PCT group.
LIMITATIONS


Preliminary results must be qualified by the small sample size.
CONCLUSIONS


Group CBSRT may be more feasible for veterans than PCT. Both CBSRT and PCT were associated with improvements in psychiatric symptoms with few differences between conditions. CBSRT is a promising new group therapy that may help address the high-rate of PTSD therapy attrition in combat veterans.
CLINICAL TRIAL REGISTRATION


NCT00984698.",2020,"Veterans in the CBSRT group had a greater reduction in the number of nightmares than veterans in the PCT group.
","['veterans with comorbid combat-related PTSD and major depressive disorder (MDD', '43 male veterans with combat-related PTSD, MDD, and disruptions in sleep or daily routine', 'veterans with posttraumatic stress disorder and major depressive disorder']","['Cognitive Behavioral Social Rhythm Group Therapy (CBSRT', 'CBSRT', 'Centered Therapy (PCT', 'CBSRT or PCT', 'Cognitive behavioral social rhythm group therapy']","['number of nightmares', 'PTSD and MDD symptoms, sleep efficiency, and number of awakenings', 'rates of attendance', 'psychiatric symptoms']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0033971', 'cui_str': 'Group psychotherapy'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0150312', 'cui_str': 'Present'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0028084', 'cui_str': 'Nightmares'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0233401', 'cui_str': 'Psychiatric symptom'}]",43.0,0.0336254,"Veterans in the CBSRT group had a greater reduction in the number of nightmares than veterans in the PCT group.
","[{'ForeName': 'Patricia L', 'Initials': 'PL', 'LastName': 'Haynes', 'Affiliation': 'Department of Health Promotion Sciences, University of Arizona, Tucson, USA; Department of Psychiatry, University of Arizona, Tucson, USA; Southern Arizona VA Health Care System, Tucson, USA. Electronic address: thaynes@email.arizona.edu.'}, {'ForeName': 'Sarah B', 'Initials': 'SB', 'LastName': 'Burger', 'Affiliation': 'Department of Health Promotion Sciences, University of Arizona, Tucson, USA.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Kelly', 'Affiliation': 'Department of Psychiatry, University of Arizona, Tucson, USA; Southern Arizona VA Health Care System, Tucson, USA; Geriatric Research, Education and Clinical Center, VA Greater Los Angeles Healthcare System, Los Angeles, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Emert', 'Affiliation': 'Department of Psychiatry, University of Arizona, Tucson, USA; Biomedical Research Foundation of Southern Arizona, Tucson, USA; Department of Psychology, University of Alabama, Tuscaloosa, USA.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Perkins', 'Affiliation': 'Southern Arizona VA Health Care System, Tucson, USA.'}, {'ForeName': 'M Tracie', 'Initials': 'MT', 'LastName': 'Shea', 'Affiliation': 'Providence VA Medical Center, Rhode Island, USA; Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Rhode Island, USA.'}]",Journal of affective disorders,['10.1016/j.jad.2020.09.009']
1619,33065822,A tailored online intervention to improve parenting risk and protective factors for child anxiety and depression: Medium-term findings from a randomized controlled trial.,"BACKGROUND


Despite considerable evidence on parenting risk and protective factors for child anxiety and depressive disorders, the development of interventions based on this evidence is still lagging behind. To address this gap, the web-based Parenting Resilient Kids (PaRK) program was developed to target these risk and protective factors. This study evaluated the effects of the program at 12-month follow-up.
METHODS


A randomized controlled trial was conducted with a community sample of 355 parents and 342 children (M child age  = 9.79). Parents randomized into the web-based PaRK intervention condition received a personalized feedback report about their parenting and were recommended a tailored course of up to 12 interactive modules. Parents in the control condition received a standard set of web-based educational factsheets.
RESULTS


Parents in the intervention group demonstrated significantly greater improvement in self-reported parenting compared to control group parents from baseline to 12-month follow-up, d = 0.24, 95% CI [0.03, 0.45]. Both groups showed reductions in child anxiety and depressive symptoms, parental psychological control and unhealthy family functioning; and improvements in parental acceptance, child- and parent- health-related quality of life.
LIMITATIONS


The PaRK intervention was tailored based on the parents' own report of their parenting behaviors. There was an over-representation of highly-educated mothers and only one parent-child dyad was included per family.
CONCLUSIONS


PaRK improved parenting for up to 12 months, but had no superior effect on children's mental health outcomes compared with an educational-factsheet intervention. Further follow-up is needed to assess longer-term effects.",2020,"RESULTS


Parents in the intervention group demonstrated significantly greater improvement in self-reported parenting compared to control group parents from baseline to 12-month follow-up, d ","['child anxiety and depressive disorders', 'community sample of 355 parents and 342 children (M child age \u202f=\u202f9.79']","['standard set of web-based educational factsheets', 'PaRK intervention', 'web-based PaRK intervention condition received a personalized feedback report about their parenting']","[""children's mental health outcomes"", 'child anxiety and depressive symptoms, parental psychological control and unhealthy family functioning; and improvements in parental acceptance, child- and parent- health-related quality of life', 'self-reported parenting']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Depressive disorder'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C5191280', 'cui_str': '342'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0680051', 'cui_str': 'Family functioning capacity'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}]",355.0,0.105364,"RESULTS


Parents in the intervention group demonstrated significantly greater improvement in self-reported parenting compared to control group parents from baseline to 12-month follow-up, d ","[{'ForeName': 'Wan Hua', 'Initials': 'WH', 'LastName': 'Sim', 'Affiliation': 'School of Psychological Sciences and Turner Institute for Brain and Mental Health, Monash University, Victoria, Australia.'}, {'ForeName': 'Luwishennadige Madhawee N', 'Initials': 'LMN', 'LastName': 'Fernando', 'Affiliation': 'School of Psychological Sciences and Turner Institute for Brain and Mental Health, Monash University, Victoria, Australia.'}, {'ForeName': 'Anthony F', 'Initials': 'AF', 'LastName': 'Jorm', 'Affiliation': 'Melbourne School of Population and Global Health, University of Melbourne, Victoria, Australia.'}, {'ForeName': 'Ronald M', 'Initials': 'RM', 'LastName': 'Rapee', 'Affiliation': 'Centre for Emotional Health, Macquarie University, New South Wales, Australia.'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Lawrence', 'Affiliation': 'School of Psychological Sciences and Turner Institute for Brain and Mental Health, Monash University, Victoria, Australia.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Mackinnon', 'Affiliation': 'Black Dog Institute, University of New South Wales, New South Wales, Australia.'}, {'ForeName': 'Marie B H', 'Initials': 'MBH', 'LastName': 'Yap', 'Affiliation': 'School of Psychological Sciences and Turner Institute for Brain and Mental Health, Monash University, Victoria, Australia; Melbourne School of Population and Global Health, University of Melbourne, Victoria, Australia. Electronic address: marie.yap@monash.edu.'}]",Journal of affective disorders,['10.1016/j.jad.2020.09.019']
1620,33066338,"Effect of a Short-Time Probiotic Supplementation on the Abundance of the Main Constituents of the Gut Microbiota of Term Newborns Delivered by Cesarean Section-A Randomized, Prospective, Controlled Clinical Trial.","The gut microbiota plays a pivotal role in the maintenance of human health. Numerous factors, including the mode of delivery, impact early gut colonization in newborns. Recent research focuses on the use of probiotics in the prevention of gut dysbiosis in newborns delivered by cesarean section (CS). The objective of this study was to determine whether a probiotic supplement given to newborns delivered by CS during their stay in the maternity ward alters the pattern of early gut colonization by lactic acid bacteria versus potential pathogens. A prospective, randomized trial was conducted. In total, 150 newborns, born at 38-40 weeks gestational age and delivered by CS, were included in the study. They were randomized into the intervention group, supplemented orally with a probiotic containing  Bifidobacterium breve  PB04 and  Lactobacillus rhamnosus  KL53A, and the control group. Stool samples were obtained on days 5 and 6 of life and after one month of life and were analyzed for the presence and abundance of the main groups of bacteria. An application of two probiotic bacteria during the first days of life after CS resulted in quick and abundant colonization by days 5 and 6, with high populations of  L. rhamnosus  and  B. breve . The applied bacterial strains were present in the majority of neonates one month after. The supplementation of term neonates delivered by cesarean section immediately after birth with a mixture of  L. rhamnosus  and  B. breve  enriched the gut microbiota composition with lactic acid bacteria.",2020,Recent research focuses on the use of probiotics in the prevention of gut dysbiosis in newborns delivered by cesarean section (CS).,"['In total, 150 newborns, born at 38-40 weeks gestational age and delivered by CS, were included in the study', 'newborns delivered by cesarean section (CS', 'newborns']","['probiotic supplement', 'Short-Time Probiotic Supplementation', 'cesarean section immediately after birth with a mixture of', 'probiotic containing  Bifidobacterium breve  PB04 and  Lactobacillus rhamnosus  KL53A, and the control group', 'L. rhamnosus  and  B']",['quick and abundant colonization'],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0314975', 'cui_str': 'Bifidobacterium breve'}, {'cui': 'C0317597', 'cui_str': 'Lactobacillus casei rhamnosus'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0456962', 'cui_str': 'Rapid'}]",150.0,0.035509,Recent research focuses on the use of probiotics in the prevention of gut dysbiosis in newborns delivered by cesarean section (CS).,"[{'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Hurkala', 'Affiliation': 'Neonatology Clinic, University Hospital, Medical College, Jagiellonian University, Kopernika 23 Str, 31-501 Kraków, Poland.'}, {'ForeName': 'Ryszard', 'Initials': 'R', 'LastName': 'Lauterbach', 'Affiliation': 'Neonatology Clinic, University Hospital, Medical College, Jagiellonian University, Kopernika 23 Str, 31-501 Kraków, Poland.'}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Radziszewska', 'Affiliation': 'Neonatology Clinic, University Hospital, Medical College, Jagiellonian University, Kopernika 23 Str, 31-501 Kraków, Poland.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Strus', 'Affiliation': 'Chair of Microbiology, Medical College, Jagiellonian University, Kraków, Czysta 18 Str, 31-121 Kraków, Poland.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Heczko', 'Affiliation': 'Chair of Microbiology, Medical College, Jagiellonian University, Kraków, Czysta 18 Str, 31-121 Kraków, Poland.'}]",Nutrients,['10.3390/nu12103128']
1621,33066348,An Acute Application of Cerebellar Transcranial Direct Current Stimulation Does Not Improve Motor Performance in Parkinson's Disease.,"Transcranial direct current stimulation of the cerebellum (c-tDCS) improves motor performance in young and old adults. Based on the cerebellar involvement in Parkinson's disease (PD), c-tDCS could have potential to improve motor function in PD. The purpose was to determine the effects of c-tDCS on motor performance in PD while participants were on medications. The study was a randomized, double-blind, SHAM-controlled, between-subjects design. Twenty-two participants with PD were allocated to either a c-tDCS group or a SHAM group. All participants completed one experimental session and performed two motor tasks with their most affected hand in a Baseline condition (no stimulation) and an Experimental condition. The motor tasks were a visuomotor isometric precision grip task (PGT) and a rapid arm movement task (AMT). The primary dependent variables were force error and endpoint error in the PGT and AMT, respectively. There were no significant differences in force error or endpoint error in the Experimental condition between the c-tDCS and SHAM groups. These results indicate that an acute application of c-tDCS does not enhance motor performance in hand and arm tasks in PD. Longer-term c-tDCS application over multiple days may be needed to enhance motor function in PD.",2020,There were no significant differences in force error or endpoint error in the Experimental condition between the c-tDCS and SHAM groups.,"[""Parkinson's Disease"", 'Twenty-two participants with PD', 'young and old adults']","['SHAM', 'Transcranial direct current stimulation of the cerebellum (c-tDCS', 'c-tDCS', 'Cerebellar Transcranial Direct Current Stimulation']","['Motor Performance', 'visuomotor isometric precision grip task (PGT) and a rapid arm movement task (AMT', 'force error and endpoint error', 'motor performance']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0007765', 'cui_str': 'Cerebellar structure'}]","[{'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0220843', 'cui_str': 'Grasp'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0443221', 'cui_str': 'Forced'}]",22.0,0.189365,There were no significant differences in force error or endpoint error in the Experimental condition between the c-tDCS and SHAM groups.,"[{'ForeName': 'Lidio', 'Initials': 'L', 'LastName': 'Lima de Albuquerque', 'Affiliation': 'Department of Kinesiology and Nutrition Sciences, University of Nevada Las Vegas, Las Vegas, NV 89154, USA.'}, {'ForeName': 'Milan', 'Initials': 'M', 'LastName': 'Pantovic', 'Affiliation': 'Department of Kinesiology and Nutrition Sciences, University of Nevada Las Vegas, Las Vegas, NV 89154, USA.'}, {'ForeName': 'Mitchel', 'Initials': 'M', 'LastName': 'Clingo', 'Affiliation': 'School of Medicine, University of Nevada Las Vegas, Las Vegas, NV 89102, USA.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Fischer', 'Affiliation': 'Department of Kinesiology and Nutrition Sciences, University of Nevada Las Vegas, Las Vegas, NV 89154, USA.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Jalene', 'Affiliation': 'Department of Kinesiology and Nutrition Sciences, University of Nevada Las Vegas, Las Vegas, NV 89154, USA.'}, {'ForeName': 'Merrill', 'Initials': 'M', 'LastName': 'Landers', 'Affiliation': 'Department of Physical Therapy, University of Nevada Las Vegas, Las Vegas, NV 89154, USA.'}, {'ForeName': 'Zoltan', 'Initials': 'Z', 'LastName': 'Mari', 'Affiliation': 'Movement Disorders Program, Cleveland Clinic Lou Ruvo Center for Brain Health, Las Vegas, NV 89106, USA.'}, {'ForeName': 'Brach', 'Initials': 'B', 'LastName': 'Poston', 'Affiliation': 'Department of Kinesiology and Nutrition Sciences, University of Nevada Las Vegas, Las Vegas, NV 89154, USA.'}]",Brain sciences,['10.3390/brainsci10100735']
1622,33066469,Chemically Activated Cooling Vest's Effect on Cooling Rate Following Exercise-Induced Hyperthermia: A Randomized Counter-Balanced Crossover Study.,"Background and objectives:  Exertional heat stroke (EHS) is a potentially lethal, hyperthermic condition that warrants immediate cooling to optimize the patient outcome. The study aimed to examine if a portable cooling vest meets the established cooling criteria (0.15 °C·min -1  or greater) for EHS treatment. It was hypothesized that a cooling vest will not meet the established cooling criteria for EHS treatment.  Materials and Methods:  Fourteen recreationally active participants (mean ± SD; male,  n  = 8; age, 25 ± 4 years; body mass, 86.7 ± 10.5 kg; body fat, 16.5 ± 5.2%; body surface area, 2.06 ± 0.15 m 2 . female,  n  = 6; 22 ± 2 years; 61.3 ± 6.7 kg; 22.8 ± 4.4%; 1.66 ± 0.11 m 2 ) exercised on a motorized treadmill in a hot climatic chamber (ambient temperature 39.8 ± 1.9 °C, relative humidity 37.4 ± 6.9%) until they reached rectal temperature (T RE ) >39 °C (mean T RE , 39.59 ± 0.38 °C). Following exercise, participants were cooled using either a cooling vest (VEST) or passive rest (PASS) in the climatic chamber until T RE  reached 38.25 °C. Trials were assigned using randomized, counter-balanced crossover design.  Results:  There was a main effect of cooling modality type on cooling rates (F[1, 24] = 10.46,  p  < 0.01, η 2 p  = 0.30), with a greater cooling rate observed in VEST (0.06 ± 0.02 °C·min -1 ) than PASS (0.04 ± 0.01 °C·min -1 ) (MD = 0.02, 95% CI = [0.01, 0.03]). There were also main effects of sex (F[1, 24] = 5.97,  p  = 0.02, η 2 p  = 0.20) and cooling modality type (F[1, 24] = 4.38,  p  = 0.047, η 2 p  = 0.15) on cooling duration, with a faster cooling time in female (26.9 min) than male participants (42.2 min) (MD = 15.3 min, 95% CI = [2.4, 28.2]) and faster cooling duration in VEST than PASS (MD = 13.1 min, 95% CI = [0.2, 26.0]). An increased body mass was associated with a decreased cooling rate in PASS (r = -0.580,  p  = 0.03); however, this association was not significant in vest (r = -0.252,  p  = 0.39).  Conclusions:  Although VEST exhibited a greater cooling capacity than PASS, VEST was far below an acceptable cooling rate for EHS treatment. VEST should not replace immediate whole-body cold-water immersion when EHS is suspected.",2020,"There was a main effect of cooling modality type on cooling rates (F[1, 24] = 10.46,  p  < 0.01, η 2 p  = 0.30), with a greater cooling rate observed in VEST (0.06 ± 0.02","['female,  n  = 6; 22 ± 2 years; 61.3 ± 6.7 kg; 22.8 ± 4.4%; 1.66 ± 0.11 m 2 ) exercised on a', 'Fourteen recreationally active participants (mean ± SD; male,  n  = 8; age, 25 ± 4 years; body mass, 86.7 ± 10.5 kg; body fat, 16.5 ± 5.2%; body surface area, 2.06 ± 0.15 m 2 ']","['VEST', '°C·min -1 ', 'cooling vest (VEST) or passive rest (PASS', 'Exercise-Induced Hyperthermia', 'motorized treadmill in a hot climatic chamber']","['cooling rate', 'cooling rates', 'faster cooling duration', 'cooling rate in PASS', 'Cooling Rate', 'faster cooling time in female', 'cooling capacity', 'cooling duration', 'body mass']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517761', 'cui_str': '4.4'}, {'cui': 'C4517510', 'cui_str': '1.66'}, {'cui': 'C4517425', 'cui_str': '0.11'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C4517521', 'cui_str': '10.5'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C4517790', 'cui_str': '5.2'}, {'cui': 'C0005902', 'cui_str': 'Body surface area'}, {'cui': 'C4068886', 'cui_str': '0.15'}]","[{'cui': 'C0453884', 'cui_str': 'Vest'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0444519', 'cui_str': 'Hot'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}]",,0.144512,"There was a main effect of cooling modality type on cooling rates (F[1, 24] = 10.46,  p  < 0.01, η 2 p  = 0.30), with a greater cooling rate observed in VEST (0.06 ± 0.02","[{'ForeName': 'Yuri', 'Initials': 'Y', 'LastName': 'Hosokawa', 'Affiliation': 'Faculty of Sport Sciences, Waseda University, Saitama 359-1192, Japan.'}, {'ForeName': 'Luke N', 'Initials': 'LN', 'LastName': 'Belval', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas and University of Texas Southwestern Medical Center, Dallas, TX 75231, USA.'}, {'ForeName': 'William M', 'Initials': 'WM', 'LastName': 'Adams', 'Affiliation': 'Department of Kinesiology, University of North Carolina at Greensboro, Greensboro, NC 27412, USA.'}, {'ForeName': 'Lesley W', 'Initials': 'LW', 'LastName': 'Vandermark', 'Affiliation': 'Department of Health, Human Performance, and Recreation, University of Arkansas, Fayetteville, AR 72701, USA.'}, {'ForeName': 'Douglas J', 'Initials': 'DJ', 'LastName': 'Casa', 'Affiliation': 'Korey Stringer Institute, Department of Kinesiology, University of Connecticut, Storrs, CT 06269, USA.'}]","Medicina (Kaunas, Lithuania)",['10.3390/medicina56100539']
1623,33066554,The Impact of Time-Restricted Diet on Sleep and Metabolism in Obese Volunteers.,"Background and objectives:  A time-restricted diet is one of the various ways to improve metabolic condition and weight control. However, until now, there have been few pieces of evidence and research to verify the methods and effectiveness of time-restricted diets on metabolic improvement and health promoting. We designed this study to make a healthy diet program and to verify the effectiveness of a time-restricted diet on general health, including sleep and metabolism, in healthy volunteers.  Materials and Methods : This study was conducted in healthy adults who are obese but do not have related metabolic disease. Fifteen participants were recruited. Before and after this program, serologic tests including ketone level, questionnaires-daytime sleepiness evaluation such as the Epworth sleepiness scale and the Stanford sleepiness scale, the Korean version of the Pittsburgh sleep questionnaire index, STOP BANG to evaluate sleep apnea, the Hospital Anxiety and Depression Scale for emotion/sleep-and polysomnography (PSG) were conducted to evaluate the effects on sleep of the program. They were divided into two groups based on ketone levels that could reflect the constancy of participation in this study. We analyzed the before and after results of each group.  Results:  Fifteen participants (nine males and six females) completed this program without significant adverse events. Body weight after this program decreased to 78.2 ± 14.1 from 82.0 ± 15.6 kg ( p  = 0.539), and BMI decreased to 27.9 ± 3.8 from 29.3 ± 4.6 kg/m 2  ( p  = 0.233). Weight loss was observed in 14 subjects except 1 participant. The results from questionnaires before and after this were not significant changes. They were classified into high/low-ketone groups according to the ketone level of the participants. In the results of the PSG, the apnea hypopnea index (25.27 ± 12.67→15.11 ± 11.50/hr,  p  = 0.25) and oxygen desaturation (18.43 ± 12.79→10.69 ± 10.0/hr,  p  = 0.004), which are indicators of sleep apnea, also improved in the high-ketone group, compared with the low-ketone group. Satisfaction interviews for this restricted diet program showed that 86% of the participants were willing to participate in the same program again.  Conclusion:  The time-restricted diet was successful in weight loss for a period of 4 weeks in obese participants, which did not affect the efficiency and architecture of sleep. In addition, successful weight loss and significant improvement of sleep apnea were showed in the high-ketone group. Further research is needed to demonstrate mechanisms for weight loss, sleep apnea, and time-restricted diets.",2020,"The time-restricted diet was successful in weight loss for a period of 4 weeks in obese participants, which did not affect the efficiency and architecture of sleep.","['14 subjects except 1 participant', 'Fifteen participants (nine males and six females', 'healthy volunteers', 'healthy adults who are obese but do not have related metabolic disease', 'Fifteen participants were recruited', 'Obese Volunteers']","['healthy diet program', 'Materials and Methods ', 'Time-Restricted Diet', 'time-restricted diet']","['BMI', 'Sleep and Metabolism', 'weight loss', 'apnea hypopnea index', 'sleep apnea', 'oxygen desaturation', 'successful weight loss', 'efficiency and architecture of sleep', 'ketone level, questionnaires-daytime sleepiness evaluation such as the Epworth sleepiness scale and the Stanford sleepiness scale, the Korean version of the Pittsburgh sleep questionnaire index, STOP BANG to evaluate sleep apnea, the Hospital Anxiety and Depression Scale for emotion/sleep-and polysomnography (PSG', 'Weight loss', 'Body weight']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0025517', 'cui_str': 'Metabolic disease'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}, {'cui': 'C0037315', 'cui_str': 'Sleep apnea'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0003737', 'cui_str': 'Architecture'}, {'cui': 'C0022634', 'cui_str': 'Ketone'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C3541276', 'cui_str': 'Epworth Sleepiness Scale'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0302363', 'cui_str': 'Infection due to Brucella abortus'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]",15.0,0.0125746,"The time-restricted diet was successful in weight loss for a period of 4 weeks in obese participants, which did not affect the efficiency and architecture of sleep.","[{'ForeName': 'Hyeyun', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': ""The Convergence Institute of Healthcare and Medical Science, Department of Neurology, Catholic Kwandong University, International St. Mary's Hospital, Incheon 22711, Korea.""}, {'ForeName': 'Bong Jin', 'Initials': 'BJ', 'LastName': 'Jang', 'Affiliation': 'Department of Medical Business Administration, Daegu Hanny University, Gyeongsangbuk-Do 38610, Korea.'}, {'ForeName': 'A Ram', 'Initials': 'AR', 'LastName': 'Jung', 'Affiliation': ""Department of Nutrition Management, Catholic Kwandong University, International St. Mary's Hospital, Incheon 22711, Korea.""}, {'ForeName': 'Jayoung', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': ""Department of Laboratory Medicine, Catholic Kwandong University, International St. Mary's Hospital, Incheon 22711, Korea.""}, {'ForeName': 'Hyo Jin', 'Initials': 'HJ', 'LastName': 'Ju', 'Affiliation': 'The Convergence Institute of Healthcare and Medical Science, College of Medicine, Catholic Kwandong University, Incheon 22711, Korea.'}, {'ForeName': 'Yeong In', 'Initials': 'YI', 'LastName': 'Kim', 'Affiliation': ""The Convergence Institute of Healthcare and Medical Science, Department of Neurology, Catholic Kwandong University, International St. Mary's Hospital, Incheon 22711, Korea.""}]","Medicina (Kaunas, Lithuania)",['10.3390/medicina56100540']
1624,33066593,Exercise Intensity May Not Moderate the Acute Effects of Functional Circuit Training on Cognitive Function: A Randomized Crossover Trial.,"Functional circuit training (FCT) has been demonstrated to acutely enhance cognitive performance (CP). However, the moderators of this observation are unknown. This study aimed to elucidate the role of exercise intensity. According to an a priori sample size calculation,  n  = 24 healthy participants (26 ± 3 years, 13 females), in randomized order, performed a single 15-min bout of FCT with low (20-39% of the heart rate reserve/HRR), moderate (40-59% HRR) or high intensity (maximal effort). Immediately pre- and post-workout, CP was measured by use of the Digit Span test, Stroop test and Trail Making test. Non-parametric data analyses did not reveal significant differences between conditions ( p  > 0.05) although parameter-free 95% confidence intervals showed pre-post improvements in some outcomes at moderate and high intensity only. The effort level does not seem to be a major effect modifier regarding short-term increases in CP following HCT in young active adults.",2020,The effort level does not seem to be a major effect modifier regarding short-term increases in CP following HCT in young active adults.,"['24 healthy participants (26 ± 3 years, 13 females', 'young active adults']","['Functional Circuit Training', 'Functional circuit training (FCT']",['Cognitive Function'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C2712423', 'cui_str': 'Circuit Training'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",24.0,0.0300091,The effort level does not seem to be a major effect modifier regarding short-term increases in CP following HCT in young active adults.,"[{'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Wilke', 'Affiliation': 'Department of Sports Medicine, Goethe University Frankfurt, 60488 Frankfurt am Main, Germany.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Royé', 'Affiliation': 'Department of Sports Medicine, Goethe University Frankfurt, 60488 Frankfurt am Main, Germany.'}]",Brain sciences,['10.3390/brainsci10100738']
1625,33066895,Remote Ischemic Post-Conditioning may Improve Post-Stroke Cognitive Impairment: A Pilot Single Center Randomized Controlled Trial.,"BACKGROUND AND PURPOSE


We aimed to demonstrate the tolerability and feasibility and the effect of remote ischemic post-conditioning on cognitive functioning in patients with post-stroke cognitive impairment.
METHODS


This was a single-center, randomized, outcome-blinded, placebo-controlled trial, randomized 1:1 to receive 4 cycles of remote ischemic post-conditioning or a sham procedure for 7 days. The primary outcome measure was tolerability and feasibility of remote ischemic post-conditioning. Secondary outcomes to measure the neurological function with national institute of health stroke scale and the cognitive impairment with Montreal Cognitive Assessment scale and Alzheimer's disease assessment scale-cognitive (at baseline, 90 days, 180 days).
RESULTS


48 patients (24 RIPC and 24 Control) were recruited. remote ischemic post-conditioning was well tolerated with 90 out of 96 cycles completed in full. 4 patients experienced vascular events in the control group: 3 cerebrovascular and 1 cardiovascular event versus only 2 cerebrovascular events in the RIPC group. We showed the similar result in the neurological function with national institute of health stroke scale score with no statistically significant differences between RIPC and control group at baseline (P = 0.796) and 90 days (P = 0.401) and 180 days (P = 0.695). But compare with baseline, it was significantly difference in the control and RIPC group at 90 days (P < 0.05) and 180 days (P < 0.05). The comparison of Montreal Cognitive Assessment scale between two groups both showed that P > 0.05 at baseline which was no statistical difference, but P < 0.05 at 90 days and 180 days which were significant statistical difference. The comparison of Alzheimer's disease assessment scale-cognitive between two groups showed that P > 0.05 at baseline (P = 0.955) and 90 days (P = 0.138) was no statistical difference, but P = 0.005<0.05 at 180 days was significant statistical difference.
CONCLUSIONS


The remote ischemic post-conditioning for post-stroke cognitive impairment was well tolerated, safe and feasible. The remote ischemic post-conditioning may improve neurological and cognitive outcomes in patients with post-stroke cognitive impairment. A larger trial is warranted. (Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: ChiCTR1800015231.).",2020,"The comparison of Alzheimer's disease assessment scale-cognitive between two groups showed that P > 0.05 at baseline (P = 0.955) and 90 days (P = 0.138) was no statistical difference, but P = 0.005<0.05 at 180 days was significant statistical difference.
","['patients with post-stroke cognitive impairment', 'Post-Stroke Cognitive Impairment', '48 patients (24 RIPC and 24 Control']","['Remote Ischemic Post-Conditioning', 'placebo', 'remote ischemic post-conditioning']","['Montreal Cognitive Assessment scale', 'neurological and cognitive outcomes', 'neurological function with national institute of health stroke scale score', 'cognitive functioning', 'tolerability and feasibility of remote ischemic post-conditioning', ""neurological function with national institute of health stroke scale and the cognitive impairment with Montreal Cognitive Assessment scale and Alzheimer's disease assessment scale-cognitive"", 'vascular events', ""Alzheimer's disease assessment scale-cognitive"", 'tolerated, safe and feasible', 'cerebrovascular and 1 cardiovascular event versus only 2 cerebrovascular events', 'tolerability and feasibility']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C2936234', 'cui_str': 'Ischemic Post-Conditioning'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0027767', 'cui_str': 'Nervous system function'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C2936234', 'cui_str': 'Ischemic Post-Conditioning'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0450989', 'cui_str': ""Alzheimer's Disease Assessment Scale""}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",,0.221334,"The comparison of Alzheimer's disease assessment scale-cognitive between two groups showed that P > 0.05 at baseline (P = 0.955) and 90 days (P = 0.138) was no statistical difference, but P = 0.005<0.05 at 180 days was significant statistical difference.
","[{'ForeName': 'Yue-Juan', 'Initials': 'YJ', 'LastName': 'Li', 'Affiliation': 'Yellow River Central Hospital of Yellow River Conservany Commission, Zhengzhou 450003, China.'}, {'ForeName': 'Ke-Ke', 'Initials': 'KK', 'LastName': 'Liang', 'Affiliation': ""The Department of Neurology, Zheng-Zhou University Province People's Hospital, Zhengzhou 450000, China.""}, {'ForeName': 'Long', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': ""The Department of Neurology, Zheng-Zhou University Province People's Hospital, Zhengzhou 450000, China.""}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Pan', 'Affiliation': ""The Department of Neurology, Zheng-Zhou University Province People's Hospital, Zhengzhou 450000, China.""}, {'ForeName': 'Ya-Mei', 'Initials': 'YM', 'LastName': 'Hu', 'Affiliation': ""Director of Department. The Department of Neurology, Zheng-Zhou University Province People's Hospital, Zhengzhou 450000, China.""}, {'ForeName': 'Jian-Hua', 'Initials': 'JH', 'LastName': 'Zhao', 'Affiliation': ""The Department of Neurology, Zheng-Zhou University Province People's Hospital, Zhengzhou 450000, China. Electronic address: sjnk2011@163.com.""}]",Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association,['10.1016/j.jstrokecerebrovasdis.2020.105217']
1626,33066921,Clinical Trial Based Rationale for the Successful Use of DOAC in the Treatment of Cerebral Venous Sinus Thrombosis (CVST): A Case Report.,"In cerebral venous sinus thrombosis (CVST), venous sinus occlusion increases venous pressure and disrupts venous return, resulting in progression to venous infarction and venous hemorrhage, with poor neurologic outcome. Therefore, early recanalization of the major venous sinus is critical. Anticoagulant therapy with continuous intravenous infusion of heparin and subsequent oral anticoagulant administration is the recommended first line of treatment for CVST. Some large clinical trials for venous thromboembolism (VTE) have shown that direct oral anticoagulant (DOAC) is non-inferior to the standard therapy with heparin or warfarin and causes less bleeding. In contrast, there are only a few reports on CVST treatment with DOAC such as Dabigatran, Rivaroxaban and Edoxaban describing good efficacy and safety. And there is one randomized clinical trial on DOAC treatment for CVST after acute phase. We report a successfully treated case of CVST in acute phase with progressive neurologic symptoms that achieved early recanalization of the obstructed sinus by an early switch from continuous intravenous infusion of heparin to oral Edoxaban.",2020,Some large clinical trials for venous thromboembolism (VTE) have shown that direct oral anticoagulant (DOAC) is non-inferior to the standard therapy with heparin or warfarin and causes less bleeding.,['Cerebral Venous Sinus Thrombosis (CVST'],"['CVST', 'Rivaroxaban and Edoxaban', 'heparin or warfarin', 'DOAC', 'heparin to oral Edoxaban', 'heparin']",[],"[{'cui': 'C0338573', 'cui_str': 'Cerebral venous sinus thrombosis'}]","[{'cui': 'C0338573', 'cui_str': 'Cerebral venous sinus thrombosis'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C2975435', 'cui_str': 'edoxaban'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}]",[],,0.0255968,Some large clinical trials for venous thromboembolism (VTE) have shown that direct oral anticoagulant (DOAC) is non-inferior to the standard therapy with heparin or warfarin and causes less bleeding.,"[{'ForeName': 'Toshiaki', 'Initials': 'T', 'LastName': 'Bando', 'Affiliation': 'Department of Neurosurgery and Stroke Center, Shinko Hospital, 1-4-47 Wakinohamacho, Chuo-ku, Kobe, Hyogo 651-0073, Japan. Electronic address: toshiakibando4@gmail.com.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Ueno', 'Affiliation': 'Department of Neurosurgery and Stroke Center, Shinko Hospital, 1-4-47 Wakinohamacho, Chuo-ku, Kobe, Hyogo 651-0073, Japan. Electronic address: yweno@hotmail.co.jp.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Shimo', 'Affiliation': 'Department of Neurosurgery and Stroke Center, Shinko Hospital, 1-4-47 Wakinohamacho, Chuo-ku, Kobe, Hyogo 651-0073, Japan. Electronic address: dmail.smail.com@gmail.com.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Kuroyama', 'Affiliation': 'Department of Neurosurgery and Stroke Center, Shinko Hospital, 1-4-47 Wakinohamacho, Chuo-ku, Kobe, Hyogo 651-0073, Japan. Electronic address: s02m025@yahoo.co.jp.'}, {'ForeName': 'Kazuyuki', 'Initials': 'K', 'LastName': 'Mikami', 'Affiliation': 'Department of Neurosurgery and Stroke Center, Shinko Hospital, 1-4-47 Wakinohamacho, Chuo-ku, Kobe, Hyogo 651-0073, Japan. Electronic address: k.co28vit.puls31@gmail.com.'}, {'ForeName': 'Shinya', 'Initials': 'S', 'LastName': 'Hori', 'Affiliation': 'Department of Neurosurgery and Stroke Center, Shinko Hospital, 1-4-47 Wakinohamacho, Chuo-ku, Kobe, Hyogo 651-0073, Japan. Electronic address: js_ely_5050@yahoo.co.jp.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Hirai', 'Affiliation': 'Department of Neurosurgery and Stroke Center, Shinko Hospital, 1-4-47 Wakinohamacho, Chuo-ku, Kobe, Hyogo 651-0073, Japan. Electronic address: hiraio@shinkohp.or.jp.'}]",Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association,['10.1016/j.jstrokecerebrovasdis.2020.105261']
1627,33066944,Comprehensive Use of Dynamic Electrical Neurostimulation and Botulinum Toxin Therapy in Patients with Post-Stroke Spasticity.,"BACKGROUND


Acute cerebrovascular accident poses a threat to the health of the nation. Dynamic electric neurostimulation decreases the excitability of the receptor apparatus, optimize microcirculatory processes, analgesic and antispasmodic effects.
METHODS


This article discusses the rehabilitation of 96 men and women with post-stroke spasticity, mean age of 60.51 ± 4.9 years, in the early recovery period after ischemic stroke, randomized into 4 equal groups: Group 1 received botulinum toxin therapy in combination with dynamic electric neurostimulation and basic therapy, including massage and therapeutic exercises; Group 2 -botulinum toxin therapy and basic therapy; Group 3 - dynamic electric neurostimulation and basic therapy; Group 4 - basic therapy only. Study methods included the use of the Modified Asworth Scale to assess spasticity, the Rivemead Motor Assessment test, and goniometry to assess the range of joint movements.
RESULTS


During a three-week observation, it was found that the inclusion of botulinum toxin therapy and dynamic electrical neurostimulation in the standard therapy of post-stroke spasticity in patients after ischemic stroke in the early recovery period contributed to patients' recovery.
CONCLUSIONS


Botulinum toxin therapy and dynamic electrical neurostimulation contributed to a more significant decrease in spasticity in the proximal and distal parts of the paretic upper extremity. It is also increased the amplitude of voluntary movements in the affected shoulder, elbow, and wrist joints, compared to the separate use of botulinum toxin therapy and dynamic electric neurostimulation as part of basic rehabilitation.",2020,"CONCLUSIONS


Botulinum toxin therapy and dynamic electrical neurostimulation contributed to a more significant decrease in spasticity in the proximal and distal parts of the paretic upper extremity.","['96 men and women with post-stroke spasticity, mean age of 60.51 ± 4.9 years, in the early recovery period after ischemic stroke', 'Patients with Post-Stroke Spasticity']","['botulinum toxin therapy', 'Botulinum toxin therapy', 'botulinum toxin therapy in combination with dynamic electric neurostimulation and basic therapy, including massage and therapeutic exercises; Group 2 -botulinum toxin therapy and basic therapy; Group 3 - dynamic electric neurostimulation and basic therapy; Group 4 - basic therapy only', 'botulinum toxin therapy and dynamic electrical neurostimulation', 'Dynamic Electrical Neurostimulation and Botulinum Toxin Therapy']","['amplitude of voluntary movements', 'spasticity']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0026838', 'cui_str': 'Spasticity'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0006055', 'cui_str': 'botulinum toxin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0521307', 'cui_str': 'Neurostimulation procedure'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0441876', 'cui_str': 'Group 4'}]","[{'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0026838', 'cui_str': 'Spasticity'}]",96.0,0.0191548,"CONCLUSIONS


Botulinum toxin therapy and dynamic electrical neurostimulation contributed to a more significant decrease in spasticity in the proximal and distal parts of the paretic upper extremity.","[{'ForeName': 'Stanislav G', 'Initials': 'SG', 'LastName': 'Abramovich', 'Affiliation': 'Department of Physical and Rehabilitation Medicine, Irkutsk State Medical Academy of Postgraduate Education - Branch of the FGBOU DPO RMANPO of the Ministry of Health of Russia, 664049, 100 Yubileynyy Microdistrict, Irkutsk, Russian Federation. Electronic address: abramovich5456@uoel.uk.'}, {'ForeName': 'Viktor A', 'Initials': 'VA', 'LastName': 'Drobyshev', 'Affiliation': 'Department of Hospital Therapy and Medical Rehabilitation, Novosibirsk State Medical University, 630091, 52 Krasnyy Ave., Novosibirsk, Russian Federation.'}, {'ForeName': 'Anna E', 'Initials': 'AE', 'LastName': 'Pyatova', 'Affiliation': 'City Center for the Rehabilitation of Patients with the Consequences of Cerebrovascular Accident, City Clinical Hospital No. 2, 630075, 21 Polzunov Str., Novosibirsk, Russian Federation.'}, {'ForeName': 'Alexei V', 'Initials': 'AV', 'LastName': 'Yumashev', 'Affiliation': 'Department of Prosthetic Dentistry, I.M. Sechenov First Moscow State Medical University (Sechenov University), 119991, 8-2 Trubetskaya Str., Moscow, Russian Federation.'}, {'ForeName': 'Elizaveta S', 'Initials': 'ES', 'LastName': 'Koneva', 'Affiliation': 'Department of Sports Medicine and Medical Rehabilitation, I.M. Sechenov First Moscow State Medical University (Sechenov University), 119991, 8-2 Trubetskaya Str., Moscow, Russian Federation.'}]",Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association,['10.1016/j.jstrokecerebrovasdis.2020.105189']
1628,33067298,Protocol for a definitive randomised controlled trial and economic evaluation of a community-based rehabilitation programme following hip fracture: fracture in the elderly multidisciplinary rehabilitation-phase III (FEMuR III).,"INTRODUCTION


Proximal femoral (hip) fracture is common, serious and costly. Rehabilitation may improve functional recovery but evidence of effectiveness and cost-effectiveness are lacking. An enhanced rehabilitation intervention was previously developed and a feasibility study tested the methods used for this randomised controlled trial (RCT). The objectives are to compare the effectiveness and cost-effectiveness of the enhanced rehabilitation programme following surgical repair of proximal femoral fracture in older people compared with usual care.
METHODS AND ANALYSIS


Protocol for phase III, parallel-group, two-armed, superiority, pragmatic RCT with 1:1 allocation ratio; allocation sequence by minimisation programme with a built-in random element; secure web-based allocation concealment. The two treatments will be usual care (control) and usual care plus an enhanced rehabilitation programme (intervention). The enhanced rehabilitation will consist of a patient-held information workbook, goal setting diary and up to six additional therapy sessions. Outcome assessment and statistical analysis will be performed blind; patient and carer participants will be unblinded. Outcomes will be measured at baseline, 17 and 52 weeks' follow-up. Primary outcome at 52 weeks will be the Nottingham Extended Activities of Daily Living scale. Secondary outcomes will measure anxiety and depression, health utility, cognitive status, hip pain intensity, falls self-efficacy, fear of falling, grip strength and physical function. Carer strain, anxiety and depression will be measured in carers. All safety events will be recorded, and serious adverse events will be assessed to determine whether they are related to the intervention and expected. Concurrent economic evaluation will be a cost-utility analysis from a health service and personal social care perspective. An embedded process evaluation will determine the mechanisms and processes that explain the implementation and impacts of the enhanced rehabilitation programme.
ETHICS AND DISSEMINATION


National Health Service research ethics approval reference 18/NE/0300. Results will be disseminated by peer-reviewed publication.
TRIAL REGISTRATION NUMBER


ISRCTN28376407; Pre-results registered on 23 November 2018.",2020,An enhanced rehabilitation intervention was previously developed and a feasibility study tested the methods used for this randomised controlled trial (RCT).,"['older people compared with usual care', 'hip fracture: fracture in the elderly multidisciplinary rehabilitation-phase III (FEMuR III']","['pragmatic RCT with 1:1 allocation ratio; allocation sequence by minimisation programme with a built-in random element; secure web-based allocation concealment', 'enhanced rehabilitation programme', 'community-based rehabilitation programme', 'usual care (control) and usual care plus an enhanced rehabilitation programme (intervention']","['effectiveness and cost-effectiveness', 'Carer strain, anxiety and depression', 'anxiety and depression, health utility, cognitive status, hip pain intensity, falls self-efficacy, fear of falling, grip strength and physical function', 'Nottingham Extended Activities of Daily Living scale']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0013879', 'cui_str': 'Chemical element'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0019559', 'cui_str': 'Hip pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0877040', 'cui_str': 'Fear of falling'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.127749,An enhanced rehabilitation intervention was previously developed and a feasibility study tested the methods used for this randomised controlled trial (RCT).,"[{'ForeName': 'Nefyn', 'Initials': 'N', 'LastName': 'Williams', 'Affiliation': 'Department of Primary Care and Mental Health, University of Liverpool Faculty of Health and Life Sciences, Liverpool, UK nefyn.williams@liverpool.ac.uk.'}, {'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Dodd', 'Affiliation': 'Liverpool Clinical Trials Centre, University of Liverpool Faculty of Health and Life Sciences, Liverpool, UK.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Hardwick', 'Affiliation': 'Liverpool Clinical Trials Centre, University of Liverpool Faculty of Health and Life Sciences, Liverpool, UK.'}, {'ForeName': 'Dannii', 'Initials': 'D', 'LastName': 'Clayton', 'Affiliation': 'Liverpool Clinical Trials Centre, University of Liverpool Faculty of Health and Life Sciences, Liverpool, UK.'}, {'ForeName': 'Rhiannon Tudor', 'Initials': 'RT', 'LastName': 'Edwards', 'Affiliation': 'Centre for Health Economics & Medicines Evaluation, Bangor University College of Human Sciences, Bangor, Gwynedd, UK.'}, {'ForeName': 'Joanna Mary', 'Initials': 'JM', 'LastName': 'Charles', 'Affiliation': 'Centre for Health Economics & Medicines Evaluation, Bangor University College of Human Sciences, Bangor, Gwynedd, UK.'}, {'ForeName': 'Phillipa', 'Initials': 'P', 'LastName': 'Logan', 'Affiliation': 'Division of Rehabilitation and Ageing, University of Nottingham Faculty of Medicine and Health Sciences, Nottingham, UK.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Busse', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Lewis', 'Affiliation': 'North Wales Centre for Primary Care Research, Bangor University College of Human Sciences, Bangor, Gwynedd, UK.'}, {'ForeName': 'Toby O', 'Initials': 'TO', 'LastName': 'Smith', 'Affiliation': 'School of Health Sciences, University of East Anglia Faculty of Medicine and Health Sciences, Norwich, Norfolk, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Sackley', 'Affiliation': 'University of Nottingham Faculty of Medicine and Health Sciences, Nottingham, UK.'}, {'ForeName': 'Val', 'Initials': 'V', 'LastName': 'Morrison', 'Affiliation': 'School of Psychology, Bangor University College of Human Sciences, Bangor, Gwynedd, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Lemmey', 'Affiliation': 'School of Sports, Health and Exercise Science, Bangor University College of Human Sciences, Bangor, Gwynedd, UK.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Masterson-Algar', 'Affiliation': 'School of Healthcare Sciences, Bangor University College of Human Sciences, Bangor, Gwynedd, UK.'}, {'ForeName': 'Lola', 'Initials': 'L', 'LastName': 'Howard', 'Affiliation': 'Liverpool Clinical Trials Centre, University of Liverpool Faculty of Health and Life Sciences, Liverpool, UK.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Hennessy', 'Affiliation': 'Liverpool Clinical Trials Centre, University of Liverpool Faculty of Health and Life Sciences, Liverpool, UK.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Soady', 'Affiliation': 'Liverpool Clinical Trials Centre, University of Liverpool Faculty of Health and Life Sciences, Liverpool, UK.'}, {'ForeName': 'Penelope', 'Initials': 'P', 'LastName': 'Ralph', 'Affiliation': 'Department of Primary Care and Mental Health, University of Liverpool Faculty of Health and Life Sciences, Liverpool, UK.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Dobson', 'Affiliation': 'Department of Primary Care and Mental Health, University of Liverpool Faculty of Health and Life Sciences, Liverpool, UK.'}, {'ForeName': 'Shanaz', 'Initials': 'S', 'LastName': 'Dorkenoo', 'Affiliation': 'Involving People Network, Health and Care Research Wales, Cardiff, UK.'}]",BMJ open,['10.1136/bmjopen-2020-039791']
1629,33067301,Effect of wheelchair-modified rowing exercise on cardiometabolic risk factors in spinal cord injured wheelchair users: protocol for a randomised controlled trial.,"INTRODUCTION


Cardiovascular and metabolic diseases are a growing concern for individuals with spinal cord injury (SCI). Physical inactivity contributes to cardiometabolic morbidity and mortality in the SCI population. However, previous studies have shown mixed results regarding the effects of exercise on cardiometabolic risk factors in individuals with SCI. This discrepancy could be influenced by insufficient exercise stimuli. Recent guidelines recommend 30 min of moderate-to-vigorous intensity aerobic exercise, three times per week, for improvement in cardiometabolic health in individuals with SCI. However, to date, no studies have implemented an exercise intervention matching the new recommendations to examine the effects on cardiometabolic risk factors. Therefore, the primary objective of this study is to determine the effects of 12 weeks of wheelchair user-modified upper-body rowing exercise on both traditional (constituents of the metabolic syndrome) and novel (eg, vascular structure and function) cardiometabolic risk factors in manual wheelchair users with SCI.
METHODS AND ANALYSIS


A randomised controlled trial will compare 12 weeks of upper-body rowing exercise, 30 min three times per week, with a control group continuing their normal lifestyle. Outcome measurements will be performed immediately before (baseline), after 6 weeks (halfway), 12 weeks of training (post) and 6 months after the termination of the intervention period (follow-up). Outcomes will include inflammatory (eg, C reactive protein) and metabolic biomarkers determined from venous blood (with serum fasting insulin as primary outcome), body composition, arterial blood pressure, cardiorespiratory fitness level, brachial artery vascular structure and function and autonomic nervous system function.
ETHICS AND DISSEMINATION


This trial is reported to the Danish Data Protection Agency (J.nr. 2019-899/10-0406) and approved by the Committees on Health Research Ethics in The North Denmark Region on 12 December 2019 (J.nr. N-20190053). The principal investigator will collect written informed consent from all participants prior to inclusion. Irrespective of study outcomes, the results will be submitted to peer-reviewed scientific journals for publication.
TRIAL REGISTRATION NUMBER


NCT04390087.",2020,"A randomised controlled trial will compare 12 weeks of upper-body rowing exercise, 30 min three times per week, with a control group continuing their normal lifestyle.","['individuals with SCI', 'manual wheelchair users with SCI', 'individuals with spinal cord injury (SCI', 'spinal cord injured wheelchair users']","['wheelchair user-modified upper-body rowing exercise', 'wheelchair-modified rowing exercise', 'upper-body rowing exercise']","['cardiometabolic risk factors', 'novel (eg, vascular structure and function) cardiometabolic risk factors', 'cardiometabolic health', 'inflammatory (eg, C reactive protein) and metabolic biomarkers determined from venous blood (with serum fasting insulin as primary outcome), body composition, arterial blood pressure, cardiorespiratory fitness level, brachial artery vascular structure and function and autonomic nervous system function', 'cardiometabolic morbidity and mortality']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0184423', 'cui_str': 'Manual wheelchair'}, {'cui': 'C0037925', 'cui_str': 'Spinal cord structure'}, {'cui': 'C0853966', 'cui_str': 'Wheelchair user'}]","[{'cui': 'C0853966', 'cui_str': 'Wheelchair user'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1268087', 'cui_str': 'Upper body structure'}, {'cui': 'C4505111', 'cui_str': 'Rowing'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0043143', 'cui_str': 'Wheelchair'}]","[{'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0229667', 'cui_str': 'Venous blood'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C1272641', 'cui_str': 'Systemic arterial pressure'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0006087', 'cui_str': 'Structure of brachial artery'}, {'cui': 'C0234593', 'cui_str': 'Autonomic nervous system function'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.0895916,"A randomised controlled trial will compare 12 weeks of upper-body rowing exercise, 30 min three times per week, with a control group continuing their normal lifestyle.","[{'ForeName': 'Rasmus Kopp', 'Initials': 'RK', 'LastName': 'Hansen', 'Affiliation': 'Sport Sciences - Performance and Technology, Department of Health Science and Technology, Aalborg University, Aalborg, Denmark rkopp@hst.aau.dk.'}, {'ForeName': 'Afshin', 'Initials': 'A', 'LastName': 'Samani', 'Affiliation': 'Sport Sciences - Performance and Technology, Department of Health Science and Technology, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Uffe', 'Initials': 'U', 'LastName': 'Laessoe', 'Affiliation': 'Department of Research and Development, University College of Northern Jutland (UCN), Aalborg, Denmark.'}, {'ForeName': 'Aase', 'Initials': 'A', 'LastName': 'Handberg', 'Affiliation': 'Department of Clinical Biochemistry, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Ryan Godsk', 'Initials': 'RG', 'LastName': 'Larsen', 'Affiliation': 'Sport Sciences - Performance and Technology, Department of Health Science and Technology, Aalborg University, Aalborg, Denmark.'}]",BMJ open,['10.1136/bmjopen-2020-040727']
1630,33067319,"Axitinib plus avelumab in the treatment of recurrent glioblastoma: a stratified, open-label, single-center phase 2 clinical trial (GliAvAx).","BACKGROUND


No treatment demonstrated to improve survival in patients with recurrent glioblastoma (rGB) in a randomized trial. Combining axitinib with the programmed cell death ligand 1 blocking monoclonal antibody avelumab may result in synergistic activity against rGB.
METHODS


Adult patients with rGB following prior surgery, radiation therapy and temozolomide chemotherapy were stratified according to their baseline use of corticosteroids. Patients with a daily dose of ≤8 mg of methylprednisolone (or equivalent) initiated treatment with axitinib (5 mg oral two times per day) plus avelumab (10 mg/kg intravenous every 2 weeks) (Cohort-1). Patients with a higher baseline corticosteroid dose initiated axitinib monotherapy; avelumab was added after 6 weeks of therapy if the corticosteroid dose could be tapered to ≤8 mg of methylprednisolone (Cohort-2). Progression-free survival at 6 months (6-m-PFS%), per immunotherapy response assessment for neuro-oncology criteria, served as the primary endpoint.
RESULTS


Between June 2017 and August 2018, 54 patients (27 per cohort) were enrolled and initiated study treatment (median age: 55 years; 63% male; 91% Eastern Cooperative Oncology Group Performance Status 0-1). Seventeen (63%) patients treated in Cohort-2 received at least one dose of avelumab. The 6-m-PFS% was 22.2% (95% CI 6.5% to 37.9%) and 18.5% (95% CI 3.8% to 33.2%) in Cohort-1 and Cohort-2, respectively; median overall survival was 26.6 weeks (95% CI 20.8 to 32.4) in Cohort-1 and 18.0 weeks (95% CI 12.5 to 23.5) in Cohort-2. The best objective response rate was 33.3% and 22.2% in Cohort-1 and Cohort-2, respectively, with a median duration of response of 17.9 and 19.0 weeks. The most frequent treatment-related adverse events were dysphonia (67%), lymphopenia (50%), arterial hypertension and diarrhea (both 48%). There were no grade 5 adverse events.
CONCLUSION


The combination of avelumab plus axitinib has an acceptable toxicity profile but did not meet the prespecified threshold for activity justifying further investigation of this treatment in an unselected population of patients with rGB.",2020,"The best objective response rate was 33.3% and 22.2% in Cohort-1 and Cohort-2, respectively, with a median duration of response of 17.9 and 19.0 weeks.","['Adult patients with rGB following prior surgery', 'patients with recurrent glioblastoma (rGB', 'recurrent glioblastoma', 'Between June 2017 and August 2018, 54 patients (27 per cohort) were enrolled and initiated study treatment (median age: 55 years; 63% male; 91% Eastern Cooperative Oncology Group Performance Status 0-1']","['radiation therapy and temozolomide chemotherapy', 'methylprednisolone', 'Axitinib plus avelumab', 'avelumab', 'avelumab plus axitinib', 'axitinib']","['lymphopenia', '6-m-PFS', 'Progression-free survival', 'arterial hypertension and diarrhea', 'median overall survival', 'objective response rate', 'survival']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0017636', 'cui_str': 'Glioblastoma'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0455610', 'cui_str': 'H/O: surgery'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0076080', 'cui_str': 'temozolomide'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C1700874', 'cui_str': 'axitinib'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4055417', 'cui_str': 'avelumab'}]","[{'cui': 'C0024312', 'cui_str': 'Lymphocytopenia'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]",,0.226783,"The best objective response rate was 33.3% and 22.2% in Cohort-1 and Cohort-2, respectively, with a median duration of response of 17.9 and 19.0 weeks.","[{'ForeName': 'Gil', 'Initials': 'G', 'LastName': 'Awada', 'Affiliation': 'Medical Oncology, Universitair Ziekenhuis Brussel, Brussels, Belgium.'}, {'ForeName': 'Laila', 'Initials': 'L', 'LastName': 'Ben Salama', 'Affiliation': 'Medical Oncology, Universitair Ziekenhuis Brussel, Brussels, Belgium.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'De Cremer', 'Affiliation': 'Psychology, Vrije Universiteit Brussel, Brussels, Brussels, Belgium.'}, {'ForeName': 'Julia Katharina', 'Initials': 'JK', 'LastName': 'Schwarze', 'Affiliation': 'Medical Oncology, Universitair Ziekenhuis Brussel, Brussels, Belgium.'}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Fischbuch', 'Affiliation': 'Medical Oncology, Universitair Ziekenhuis Brussel, Brussels, Belgium.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Seynaeve', 'Affiliation': 'Neurology, Universitair Ziekenhuis Brussel, Brussels, Belgium.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Du Four', 'Affiliation': 'Neurosurgery, Universitair Ziekenhuis Brussel, Brussels, Belgium.'}, {'ForeName': 'Anne-Marie', 'Initials': 'AM', 'LastName': 'Vanbinst', 'Affiliation': 'Radiology, Universitair Ziekenhuis Brussel, Brussels, Belgium.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Michotte', 'Affiliation': 'Pathology, Universitair Ziekenhuis Brussel, Brussels, Belgium.'}, {'ForeName': 'Hendrik', 'Initials': 'H', 'LastName': 'Everaert', 'Affiliation': 'Nuclear Medicine, Universitair Ziekenhuis Brussel, Brussels, Belgium.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Rogiers', 'Affiliation': 'Psychiatry, Centre Hospitalier Universitaire Brugmann, Brussels, Belgium.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Theuns', 'Affiliation': 'Psychology, Vrije Universiteit Brussel, Brussels, Brussels, Belgium.'}, {'ForeName': 'Johnny', 'Initials': 'J', 'LastName': 'Duerinck', 'Affiliation': 'Neurosurgery, Universitair Ziekenhuis Brussel, Brussels, Belgium.'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'Neyns', 'Affiliation': 'Medical Oncology, Universitair Ziekenhuis Brussel, Brussels, Belgium bart.neyns@uzbrussel.be.'}]",Journal for immunotherapy of cancer,['10.1136/jitc-2020-001146']
1631,31228190,Genetic variation at the coronary artery disease risk locus GUCY1A3 modifies cardiovascular disease prevention effects of aspirin.,"AIMS


Efficacy of aspirin in primary prevention of cardiovascular disease (CVD) may be influenced by a common allele in guanylate cyclase GUCY1A3, which has been shown to modify platelet function and increase CVD risk.
METHODS AND RESULTS


We investigated whether homozygotes of the GUCY1A3 rs7692387 risk (G) allele benefited from aspirin in two long-term, randomized placebo-controlled trials of aspirin in primary CVD prevention: the Women's Genome Health Study (WGHS, N = 23 294) and a myocardial infarction (MI, N = 550) and stroke (N = 382) case-control set from the Physician's Health Study (PHS, N = 22 071). Bleeding risk was evaluated in the WGHS. In the placebo group of the WGHS, the GUCY1A3 risk (G) allele was confirmed to increase CVD risk [hazard ratio 1.38; 95% confidence interval (CI) 1.08-1.78; P = 0.01]. Random-effects meta-analysis of the WGHS and PHS revealed that aspirin reduced CVD events among risk allele homozygotes [G/G: odds ratio (OR) 0.79; 95% CI 0.65-0.97; P = 0.03] but increased CVD events among non-risk allele carriers (e.g. G/A: OR 1.39; 95% CI 1.03-1.87; P = 0.03) thus implying an interaction between genotype stratum and aspirin intake (Pinteraction = 0.01). Bleeding associated with aspirin increased in all genotype groups, with higher risks in heterozygotes.
CONCLUSION


In two randomized placebo-controlled trials in the setting of primary prevention, aspirin reduced the incidence of CVD events in individuals homozygous for the GUCY1A3 risk (G) allele, whereas heterozygote individuals had more events when taking aspirin.",2019,"Bleeding associated with aspirin increased in all genotype groups, with higher risks in heterozygotes.
","['individuals homozygous for the GUCY1A3 risk (G) allele, whereas heterozygote individuals', ""primary CVD prevention: the Women's Genome Health Study (WGHS, N\u2009"", ""23\xa0294) and a myocardial infarction (MI, N\u2009=\u2009550) and stroke (N\u2009=\u2009382) case-control set from the Physician's Health Study (PHS, N\u2009=\u200922\xa0071""]","['placebo', 'aspirin']","['incidence of CVD events', 'CVD risk', 'CVD events', 'Bleeding risk']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019904', 'cui_str': 'Homozygote'}, {'cui': 'C1519418', 'cui_str': 'GUCY1A3 protein, human'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0002085', 'cui_str': 'Genetic alleles'}, {'cui': 'C0019425', 'cui_str': 'Heterozygote'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0017428', 'cui_str': 'Genome'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C3844103', 'cui_str': '550'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C4517750', 'cui_str': '382'}, {'cui': 'C0007328', 'cui_str': 'Case Control Studies'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0031831', 'cui_str': 'Physician'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",,0.283633,"Bleeding associated with aspirin increased in all genotype groups, with higher risks in heterozygotes.
","[{'ForeName': 'Kathryn T', 'Initials': 'KT', 'LastName': 'Hall', 'Affiliation': ""Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, 900 Commonwealth Avenue, Boston, MA 02146, USA.""}, {'ForeName': 'Thorsten', 'Initials': 'T', 'LastName': 'Kessler', 'Affiliation': 'Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen, Technische Universität München, Deutsches Zentrum für Herz- und Kreislauf-Forschung (DZHK) e.V., Partner Site Munich Heart Alliance, Lazarettstrasse 36, 80636 Munich, Germany.'}, {'ForeName': 'Julie E', 'Initials': 'JE', 'LastName': 'Buring', 'Affiliation': ""Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, 900 Commonwealth Avenue, Boston, MA 02146, USA.""}, {'ForeName': 'Dani', 'Initials': 'D', 'LastName': 'Passow', 'Affiliation': ""Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, 900 Commonwealth Avenue, Boston, MA 02146, USA.""}, {'ForeName': 'Howard D', 'Initials': 'HD', 'LastName': 'Sesso', 'Affiliation': ""Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, 900 Commonwealth Avenue, Boston, MA 02146, USA.""}, {'ForeName': 'Robert Y L', 'Initials': 'RYL', 'LastName': 'Zee', 'Affiliation': 'Department of Pediatric Dentistry, Tufts University School of Dental Medicine, Boston, MA, USA.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Ridker', 'Affiliation': ""Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, 900 Commonwealth Avenue, Boston, MA 02146, USA.""}, {'ForeName': 'Daniel I', 'Initials': 'DI', 'LastName': 'Chasman', 'Affiliation': ""Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, 900 Commonwealth Avenue, Boston, MA 02146, USA.""}, {'ForeName': 'Heribert', 'Initials': 'H', 'LastName': 'Schunkert', 'Affiliation': 'Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen, Technische Universität München, Deutsches Zentrum für Herz- und Kreislauf-Forschung (DZHK) e.V., Partner Site Munich Heart Alliance, Lazarettstrasse 36, 80636 Munich, Germany.'}]",European heart journal,['10.1093/eurheartj/ehz384']
1632,31293563,Duration of Humoral and Cellular Immunity 8 Years After Administration of Reduced Doses of the 17DD-Yellow Fever Vaccine.,"The present study aims to determine whether 17DD-YF-specific humoral and cellular immunological memory is maintained 8-years after primary vaccination with subdoses (10,447IU;3,013IU;587IU;158IU;31IU). For this purpose, this follow-up study was carried out in a subset of volunteers ( n  = 98) originally enrolled in the dose-response study in 2009 and 46 non-vaccinated controls. Our results demonstrated that vaccinees, who had seroconverted following primary vaccination and had not been revaccinated, present similar neutralizing antibodies levels and YF-specific cellular memory, particularly CMCD4 and EMCD8 as compared to the reference full dose (27,476IU). Although, PRNT seropositivity rates were similar across subgroups (94, 82, 83, 94, 80, and 91%, correspondingly), only doses above 587IU elicited similar iterative proportion of seropositivity rates, calculated as a progressive decrease on seropositivity rates along time (89, 80, 80, and 91%, respectively) as compared to 158IU and 31IU (68 and 46%, respectively). Noteworthy were the strong positive correlations (""EMCD4,EMCD8"" and ""TNFCD8,IFNCD8"") observed in most subdoses, except for 31IU. Major similarities underscored the preserved antibody titers and the outstanding levels of EMCD8, relevant correlates of protection for YF-specific immunity. These findings provide evidences to support the regular use of dose sparing strategy for YF vaccine in adults.",2019,"Noteworthy were the strong positive correlations (""EMCD4,EMCD8"" and ""TNFCD8,IFNCD8"") observed in most subdoses, except for 31IU.","['adults', 'maintained 8-years after primary vaccination with subdoses (10,447IU;3,013IU;587IU;158IU;31IU', 'subset of volunteers ( n  = 98) originally enrolled in the dose-response study in 2009 and 46 non-vaccinated controls']",[],"['Duration of Humoral and Cellular Immunity 8 Years', 'seropositivity rates', 'PRNT seropositivity rates']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],"[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0020966', 'cui_str': 'Cell-Mediated Immunity'}, {'cui': 'C0439234', 'cui_str': 'year'}]",,0.0503876,"Noteworthy were the strong positive correlations (""EMCD4,EMCD8"" and ""TNFCD8,IFNCD8"") observed in most subdoses, except for 31IU.","[{'ForeName': 'Ismael Artur', 'Initials': 'IA', 'LastName': 'da Costa-Rocha', 'Affiliation': 'Grupo Integrado de Pesquisas em Biomarcadores, Instituto René Rachou, Fundação Oswaldo Cruz - FIOCRUZ-Minas, Belo Horizonte, Brazil.'}, {'ForeName': 'Ana Carolina', 'Initials': 'AC', 'LastName': 'Campi-Azevedo', 'Affiliation': 'Grupo Integrado de Pesquisas em Biomarcadores, Instituto René Rachou, Fundação Oswaldo Cruz - FIOCRUZ-Minas, Belo Horizonte, Brazil.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Peruhype-Magalhães', 'Affiliation': 'Grupo Integrado de Pesquisas em Biomarcadores, Instituto René Rachou, Fundação Oswaldo Cruz - FIOCRUZ-Minas, Belo Horizonte, Brazil.'}, {'ForeName': 'Jordana Grazziela', 'Initials': 'JG', 'LastName': 'Coelho-Dos-Reis', 'Affiliation': 'Grupo Integrado de Pesquisas em Biomarcadores, Instituto René Rachou, Fundação Oswaldo Cruz - FIOCRUZ-Minas, Belo Horizonte, Brazil.'}, {'ForeName': 'Jordana Rodrigues Barbosa', 'Initials': 'JRB', 'LastName': 'Fradico', 'Affiliation': 'Grupo Integrado de Pesquisas em Biomarcadores, Instituto René Rachou, Fundação Oswaldo Cruz - FIOCRUZ-Minas, Belo Horizonte, Brazil.'}, {'ForeName': 'Thalles', 'Initials': 'T', 'LastName': 'Souza-Lopes', 'Affiliation': 'Grupo Integrado de Pesquisas em Biomarcadores, Instituto René Rachou, Fundação Oswaldo Cruz - FIOCRUZ-Minas, Belo Horizonte, Brazil.'}, {'ForeName': 'Laise Rodrigues', 'Initials': 'LR', 'LastName': 'Reis', 'Affiliation': 'Grupo Integrado de Pesquisas em Biomarcadores, Instituto René Rachou, Fundação Oswaldo Cruz - FIOCRUZ-Minas, Belo Horizonte, Brazil.'}, {'ForeName': 'Larissa Chaves', 'Initials': 'LC', 'LastName': 'Freire', 'Affiliation': 'Grupo Integrado de Pesquisas em Biomarcadores, Instituto René Rachou, Fundação Oswaldo Cruz - FIOCRUZ-Minas, Belo Horizonte, Brazil.'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Costa-Pereira', 'Affiliation': 'Grupo Integrado de Pesquisas em Biomarcadores, Instituto René Rachou, Fundação Oswaldo Cruz - FIOCRUZ-Minas, Belo Horizonte, Brazil.'}, {'ForeName': 'Juliana Vaz de Melo', 'Initials': 'JVM', 'LastName': 'Mambrini', 'Affiliation': 'Núcleo de Estudos em Saúde Pública e Envelhecimento, Instituto René Rachou, Fundação Oswaldo Cruz - FIOCRUZ-Minas, Belo Horizonte, Brazil.'}, {'ForeName': 'Maria de Lourdes de Sousa', 'Initials': 'MLS', 'LastName': 'Maia', 'Affiliation': 'Assessoria Clínica, Instituto de Tecnologia em Imunobiológicos Bio-Manguinhos - FIOCRUZ, Rio de Janeiro, Brazil.'}, {'ForeName': 'Sheila Maria Barbosa', 'Initials': 'SMB', 'LastName': 'de Lima', 'Affiliation': 'Laboratório de Tecnologia Virológica, Instituto de Tecnologia em Imunobiológicos Bio-Manguinhos - FIOCRUZ, Rio de Janeiro, Brazil.'}, {'ForeName': 'Tatiana Guimarães', 'Initials': 'TG', 'LastName': 'de Noronha', 'Affiliation': 'Assessoria Clínica, Instituto de Tecnologia em Imunobiológicos Bio-Manguinhos - FIOCRUZ, Rio de Janeiro, Brazil.'}, {'ForeName': 'Janaina Reis', 'Initials': 'JR', 'LastName': 'Xavier', 'Affiliation': 'Assessoria Clínica, Instituto de Tecnologia em Imunobiológicos Bio-Manguinhos - FIOCRUZ, Rio de Janeiro, Brazil.'}, {'ForeName': 'Luiz Antonio Bastos', 'Initials': 'LAB', 'LastName': 'Camacho', 'Affiliation': 'Departamento de Epidemiologia e Métodos Quantitativos em Saúde - Escola Nacional de Saúde Pública - FIOCRUZ, Rio de Janeiro, Brazil.'}, {'ForeName': 'Elizabeth Maciel', 'Initials': 'EM', 'LastName': 'de Albuquerque', 'Affiliation': 'Assessoria Clínica, Instituto de Tecnologia em Imunobiológicos Bio-Manguinhos - FIOCRUZ, Rio de Janeiro, Brazil.'}, {'ForeName': 'Roberto Henrique Guedes', 'Initials': 'RHG', 'LastName': 'Farias', 'Affiliation': 'Instituto de Biologia do Exército, Rio de Janeiro, Brazil.'}, {'ForeName': 'Thalita da Matta', 'Initials': 'TDM', 'LastName': 'de Castro', 'Affiliation': 'Assessoria Clínica, Instituto de Tecnologia em Imunobiológicos Bio-Manguinhos - FIOCRUZ, Rio de Janeiro, Brazil.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Homma', 'Affiliation': 'Assessoria Clínica, Instituto de Tecnologia em Imunobiológicos Bio-Manguinhos - FIOCRUZ, Rio de Janeiro, Brazil.'}, {'ForeName': 'Alessandro Pecego Martins', 'Initials': 'APM', 'LastName': 'Romano', 'Affiliation': 'Departamento de Vigilância das Doenças Transmissíveis, Secretaria de Vigilância em Saúde, Ministério da Saúde, Brasília, Brazil.'}, {'ForeName': 'Carla Magda', 'Initials': 'CM', 'LastName': 'Domingues', 'Affiliation': 'Departamento de Vigilância das Doenças Transmissíveis, Secretaria de Vigilância em Saúde, Ministério da Saúde, Brasília, Brazil.'}, {'ForeName': 'Reinaldo de Menezes', 'Initials': 'RM', 'LastName': 'Martins', 'Affiliation': 'Assessoria Clínica, Instituto de Tecnologia em Imunobiológicos Bio-Manguinhos - FIOCRUZ, Rio de Janeiro, Brazil.'}, {'ForeName': 'Andréa', 'Initials': 'A', 'LastName': 'Teixeira-Carvalho', 'Affiliation': 'Grupo Integrado de Pesquisas em Biomarcadores, Instituto René Rachou, Fundação Oswaldo Cruz - FIOCRUZ-Minas, Belo Horizonte, Brazil.'}, {'ForeName': 'Olindo Assis', 'Initials': 'OA', 'LastName': 'Martins-Filho', 'Affiliation': 'Grupo Integrado de Pesquisas em Biomarcadores, Instituto René Rachou, Fundação Oswaldo Cruz - FIOCRUZ-Minas, Belo Horizonte, Brazil.'}]",Frontiers in immunology,['10.3389/fimmu.2019.01211']
1633,31545357,THEMIS and THEMIS-PCI.,,2019,,[],[],[],[],[],[],,0.0190572,,"[{'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Brigham and Women's Hospital Heart & Vascular Center Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Philippe Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'French Alliance for Cardiovascular Trials Assistance Publique-Hôpitaux de Paris Hôpital Bichat, Université de Paris Institut National de la Santé et de la Recherche Médicale U-1148 Paris, France.'}]",European heart journal,['10.1093/eurheartj/ehz707']
1634,31731109,Safety of retigabine in adults with partial-onset seizures after long-term exposure: focus on unexpected ophthalmological and dermatological events.,"BACKGROUND


Retigabine is an antiepileptic drug developed for the adjunctive treatment of adults with epilepsy and partial-onset seizures (POS). Following its approval in 2011, reports of ophthalmological/dermatological pigmentation/discoloration led to a restriction of the indication in 2013, and in 2017, retigabine was voluntarily withdrawn from the market because of its limited usage. Here, data are reported from four open-label extension studies focusing on long-term safety with particular emphasis on ophthalmological and dermatological events.
METHODS


Studies 113413 (NCT01336621), 114873 (NCT01777139), 115097 (NCT00310388), and 115098 (NCT00310375) were multicenter, open-label extension studies of retigabine (300-1200 mg/day) for the adjunctive treatment of adults with POS. Safety assessments included monitoring treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs). When new safety issues were identified, protocols were amended to include additional on-treatment safety evaluations, including ophthalmological and dermatological examinations. Patients who had abnormal retinal pigmentation, unexplained vision change, pigmentation of nonretinal ocular tissue, or abnormal discoloration of skin, lips, nails, and/or mucosa at the end of the treatment phase were asked to enter a safety follow-up continuation phase comprising 6-monthly ophthalmological/dermatological assessments.
RESULTS


The safety population (patients receiving ≥1 dose of retigabine in the open-label phase) comprised 98, 30, 376, and 181 patients for studies 113413, 114873, 115097, and 115098, respectively. Mean (standard deviation) treatment exposure ranged from 529 (424) to 1129 (999) days. In total, 68%-96% and 4%-27% of patients across the studies experienced TEAEs and TE SAEs, respectively. There were seven on-treatment deaths and two after discontinuation. Overall, 14%-73% of patients had an on-treatment eye examination, of whom 8/53, 4/22, 17/54, and 14/36 had abnormal retinal pigmentation and 15/53, 7/22, 15/54, and 11/36 had nonretinal ocular pigmentation in studies 113413, 114873, 115097, and 115098, respectively. Four patients had confirmed acquired vitelliform maculopathy. In patients with unresolved events at discontinuation and ≥1 posttreatment follow-up, retinal pigmentation resolved completely in 1/3, 0/3, 0/10, and 1/7 patients and nonretinal ocular pigmentation in 1/4, 0/3, 8/10, and 4/6 patients, respectively. Overall, 12%-83% of patients had an on-treatment dermatological examination, of whom 11/58, 0/25, 23/46, and 23/37 had any-tissue discoloration, respectively. In patients with unresolved events at discontinuation and ≥1 posttreatment follow-up, discoloration of skin, lips, nails, and/or mucosa resolved completely in 2/3, 0/0, 7/13, and 1/11 patients, respectively.
CONCLUSIONS


The safety profile of retigabine in adults with POS across four open-label studies was generally consistent with data from previous placebo-controlled studies. Discoloration of various tissues occurred in a proportion of patients treated with retigabine and resolved completely in a small number of these patients following treatment discontinuation. In addition, comprehensive eye examination identified a new adverse reaction of acquired vitelliform maculopathy in a limited number of patients.",2020,"In patients with unresolved events at discontinuation and ≥1 posttreatment follow-up, retinal pigmentation resolved completely in 1/3, 0/3, 0/10, and 1/7 patients and nonretinal ocular pigmentation in 1/4, 0/3, 8/10, and 4/6 patients, respectively.","['adults with POS', 'adults with partial-onset seizures after long-term exposure', 'population (patients receiving ≥1 dose of retigabine in the open-label phase) comprised 98, 30, 376, and 181 patients for studies 113413, 114873, 115097, and 115098, respectively', 'adults with epilepsy and partial-onset seizures (POS', 'Four patients had confirmed acquired vitelliform maculopathy', 'Patients who had abnormal retinal pigmentation, unexplained vision change, pigmentation of nonretinal ocular tissue, or abnormal discoloration of skin, lips, nails, and/or mucosa at the end of the treatment phase were asked to enter a safety follow-up continuation phase comprising 6-monthly ophthalmological/dermatological assessments', 'Studies 113413 (NCT01336621), 114873']",['retigabine'],"['discoloration of skin, lips, nails, and/or mucosa resolved completely', 'Safety assessments included monitoring treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs', 'nonretinal ocular pigmentation', 'retinal pigmentation', 'Discoloration of various tissues', 'abnormal retinal pigmentation']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0530684', 'cui_str': 'ezogabine'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0439661', 'cui_str': 'Acquired'}, {'cui': 'C0024437', 'cui_str': 'Degenerative disorder of macula'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0151892', 'cui_str': 'Retinal pigmentation'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0031911', 'cui_str': 'Pigmentation'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0151907', 'cui_str': 'Discoloration of skin'}, {'cui': 'C0023759', 'cui_str': 'Lip structure'}, {'cui': 'C0027342', 'cui_str': 'Nail plate structure'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1172410', 'cui_str': 'ASK protein, human'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C2013096', 'cui_str': 'OPHTHALMOLOGICALS'}, {'cui': 'C0011625', 'cui_str': 'DERMATOLOGICALS'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0530684', 'cui_str': 'ezogabine'}]","[{'cui': 'C0151907', 'cui_str': 'Discoloration of skin'}, {'cui': 'C0023759', 'cui_str': 'Lip structure'}, {'cui': 'C0027342', 'cui_str': 'Nail plate structure'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C3714811', 'cui_str': 'Resolved'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0031911', 'cui_str': 'Pigmentation'}, {'cui': 'C0151892', 'cui_str': 'Retinal pigmentation'}, {'cui': 'C0332572', 'cui_str': 'Abnormal color'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}]",,0.0798079,"In patients with unresolved events at discontinuation and ≥1 posttreatment follow-up, retinal pigmentation resolved completely in 1/3, 0/3, 0/10, and 1/7 patients and nonretinal ocular pigmentation in 1/4, 0/3, 8/10, and 4/6 patients, respectively.","[{'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Brickel', 'Affiliation': 'GSK, Uxbridge, Middlesex, UK.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Hewett', 'Affiliation': 'GSK, Stevenage, Hertfordshire, UK.'}, {'ForeName': 'Kirsty', 'Initials': 'K', 'LastName': 'Rayner', 'Affiliation': 'Probabilitas Consulting Limited, Berkhamsted, Hertfordshire, UK.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'McDonald', 'Affiliation': 'GSK, Research Triangle Park, NC, USA. Electronic address: susan.a.mcdonald@gsk.com.'}, {'ForeName': 'Jeni', 'Initials': 'J', 'LastName': ""De'Ath"", 'Affiliation': 'GSK, Uxbridge, Middlesex, UK.'}, {'ForeName': 'Jerzy', 'Initials': 'J', 'LastName': 'Daniluk', 'Affiliation': 'GSK, Warsaw, Poland. Electronic address: jerzy.2.daniluk@gsk.com.'}, {'ForeName': 'Kalpesh', 'Initials': 'K', 'LastName': 'Joshi', 'Affiliation': 'GSK, Mumbai, India. Electronic address: kalpesh.k.joshi@gsk.com.'}, {'ForeName': 'Marie Catherine', 'Initials': 'MC', 'LastName': 'Boll', 'Affiliation': 'Instituto Nacional de Neurologia y Neurocirugia ""Manuel Velasco Suarez"", Tlalpan, Mexico.'}, {'ForeName': 'Somsak', 'Initials': 'S', 'LastName': 'Tiamkao', 'Affiliation': 'Division of Neurology, Department of Medicine, Faculty of Medicine, Integrated Epilepsy Research Group, Khon Kaen University, Thailand.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Vorobyeva', 'Affiliation': 'Central Clinical Hospital #2 OAO RZD, Rehabilitation Department, Moscow, Russia; IM Sechenov First Moscow State Medical University (Sechenovskiy University), Ministry of Health, Russia.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Cooper', 'Affiliation': 'GSK, Brentford, Middlesex, UK. Electronic address: james.5.cooper@gsk.com.'}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2019.106580']
1635,31811456,Three-dimensional imaging improved the laparoscopic performance of inexperienced operators: a prospective trial.,"BACKGROUND


Three-dimensional (3-D) high-definition (HD) stereovision and two-dimensional (2-D) ultra-high-resolution (4K) monitors have recently become available for laparoscopic surgery. The aim of this study was to compare laparoscopic performance between inexperienced participants using 3-D/HD and 2-D/4K monitors and those using conventional 2-D/HD monitors.
METHODS


The study enrolled 66 participants with no previous surgical experience or medical training. They were randomly divided into three equal groups, each using a different type of monitor (2-D/HD, 2-D/4K, or 3-D/HD), to perform three phantom tasks using a laparoscopic simulator: Task 1, touching markers on a non-flat surface; Task 2, bimanual peg transfer; and Task 3, passing a straight rod through a loop. Each task was performed three times. The performance scores (operative time, path length of the forceps, and technical errors) were compared for each monitor type and by age group (< 30 vs. > 30 years).
RESULTS


For all three tasks, scores using the 3-D monitor were significantly better than those using either 2-D monitor, with no difference between the 2-D/4K and 2-D/HD monitors. Using the 2-D monitors, the performance of Task 3 by the participants > 30 years was worse than that by the younger participants; however, there was no difference between the age groups when using the 3-D monitor.
CONCLUSION


Participants with no prior experience using a 3-D monitor showed better laparoscopic performance than those using 2-D monitors, even with 4K resolution. This improvement was more marked in older participants, suggesting a greater loss of depth perception in a 2-D environment.",2020,"For all three tasks, scores using the 3-D monitor were significantly better than those using either 2-D monitor, with no difference between the 2-D/4K and 2-D/HD monitors.","['inexperienced participants using', 'Participants with no prior experience', 'older participants', '66 participants with no previous surgical experience or medical training']","['3-D/HD and 2-D/4K monitors and those using conventional 2-D/HD monitors', 'laparoscopic simulator: Task 1, touching markers on a non-flat surface; Task 2, bimanual peg transfer; and Task 3, passing a straight rod through a loop']","['laparoscopic performance', 'loss of depth perception', 'performance scores (operative time, path length of the forceps, and technical errors']","[{'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0183309', 'cui_str': 'Simulator'}, {'cui': 'C0152054', 'cui_str': 'Touch'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205324', 'cui_str': 'Flat'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0032478', 'cui_str': 'Polyethylene Glycol 400'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0019421', 'cui_str': 'Heterosexuality'}, {'cui': 'C0035086', 'cui_str': 'Renal osteodystrophy'}, {'cui': 'C4505203', 'cui_str': 'A-Loop'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0011586', 'cui_str': 'Stereoscopic vision'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0016533', 'cui_str': 'Forceps'}, {'cui': 'C0449851', 'cui_str': 'Technique'}]",66.0,0.0377614,"For all three tasks, scores using the 3-D monitor were significantly better than those using either 2-D monitor, with no difference between the 2-D/4K and 2-D/HD monitors.","[{'ForeName': 'Shingo', 'Initials': 'S', 'LastName': 'Kanaji', 'Affiliation': 'IRCAD, Research Institute Against Digestive Cancer, Strasbourg, France. kanashin@med.kobe-u.ac.jp.'}, {'ForeName': 'Ryohei', 'Initials': 'R', 'LastName': 'Watanabe', 'Affiliation': 'IRCAD, Research Institute Against Digestive Cancer, Strasbourg, France.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Mascagni', 'Affiliation': 'IHU-Strasbourg, Institute of Image-Guided Surgery, Strasbourg, France.'}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Trauzettel', 'Affiliation': 'IHU-Strasbourg, Institute of Image-Guided Surgery, Strasbourg, France.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Urade', 'Affiliation': 'IHU-Strasbourg, Institute of Image-Guided Surgery, Strasbourg, France.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Longo', 'Affiliation': 'IHU-Strasbourg, Institute of Image-Guided Surgery, Strasbourg, France.'}, {'ForeName': 'Ludovica', 'Initials': 'L', 'LastName': 'Guerriero', 'Affiliation': 'IHU-Strasbourg, Institute of Image-Guided Surgery, Strasbourg, France.'}, {'ForeName': 'Silvana', 'Initials': 'S', 'LastName': 'Perretta', 'Affiliation': 'IRCAD, Research Institute Against Digestive Cancer, Strasbourg, France.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Dallemagne', 'Affiliation': 'IRCAD, Research Institute Against Digestive Cancer, Strasbourg, France.'}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Kakeji', 'Affiliation': 'Division of Gastrointestinal Surgery, Department of Surgery, Graduate School of Medicine, Kobe University, Kobe, Japan.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Marescaux', 'Affiliation': 'IRCAD, Research Institute Against Digestive Cancer, Strasbourg, France.'}]",Surgical endoscopy,['10.1007/s00464-019-07308-6']
1636,33084205,Three-dimensional analysis of dimensional changes after alveolar ridge preservation with bone substitutes or plasma rich in growth factors: Randomized and controlled clinical trial.,"OBJECTIVES


To evaluate alveolar ridge dimensional changes of different alveolar ridge preservation techniques after 3 months of tooth extraction and to compare the efficacy of autologous plasma rich in growth factor (PRGF) to the bone substitutes in alveolar ridge preservation and sites left to heal spontaneously.
MATERIALS AND METHODS


Forty patients requiring tooth extraction in the anterior maxilla were randomly allocated to the four following treatment modalities: spontaneous healing (control), natural bovine bone mineral covered with resorbable native collagen membrane (BBM/CM), freeze-dried bone allograft covered with resorbable native collagen membrane (FDBA/CM) and PRGF alone. Cone beam computed tomography (CBCT) scans were taken after surgery and 3 months later. The measurements of height and width (at 1, 3, and 5 mm below the crest) were performed after superimposing the 2 consecutive CBCT scans.
RESULTS


The greatest horizontal alveolar bone resorption at 1 mm below bone crest was observed in the control group (-1.61 ± 1.76 mm, P = .037), whereas the least reduction in width was found in the BBM/CM group (-0.68 ± 0.67 mm, P = .037). The most pronounced alveolar height reduction was observed in the control group (-0.86 ± 0.43 mm), whereas alveolar ridge preservation with BBMC/CM (-0.26 ± 0.91 mm) and PRGF (-0.54 ± 0.86 mm) successfully reduced the alveolar height reduction as compared to the control group.
CONCLUSIONS


Alveolar ridge preservation technique in the esthetic zone using BBM/CM or using PRGF is beneficial to reduce horizontal and vertical bone changes.",2020,"The most pronounced alveolar height reduction was observed in the control group (-0.86 ± 0.43 mm), whereas alveolar ridge preservation with BBMC/CM (-0.26 ± 0.91 mm) and PRGF (-0.54 ± 0.86 mm) successfully reduced the alveolar height reduction as compared to the control group.
","['growth factors', 'Forty patients requiring tooth extraction in the anterior maxilla']","['Cone beam computed tomography (CBCT) scans', 'spontaneous healing (control), natural bovine bone mineral covered with resorbable native collagen membrane (BBM/CM), freeze-dried bone allograft covered with resorbable native collagen membrane (FDBA/CM) and PRGF alone']","['least reduction in width', 'alveolar ridge preservation with BBMC/CM', 'greatest horizontal alveolar bone resorption', 'alveolar height reduction']","[{'cui': 'C0018284', 'cui_str': 'Growth factor'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040440', 'cui_str': 'Tooth extraction'}, {'cui': 'C0459697', 'cui_str': 'Anterior segment of maxilla'}]","[{'cui': 'C1956110', 'cui_str': 'Cone beam CT'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0016698', 'cui_str': 'Lyophilization'}, {'cui': 'C0407564', 'cui_str': 'Allogeneic bone graft'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0018284', 'cui_str': 'Growth factor'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0447411', 'cui_str': 'Alveolar ridge structure'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C3805122', 'cui_str': 'Alveolar bone resorption'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}]",40.0,0.0231365,"The most pronounced alveolar height reduction was observed in the control group (-0.86 ± 0.43 mm), whereas alveolar ridge preservation with BBMC/CM (-0.26 ± 0.91 mm) and PRGF (-0.54 ± 0.86 mm) successfully reduced the alveolar height reduction as compared to the control group.
","[{'ForeName': 'Arturas', 'Initials': 'A', 'LastName': 'Stumbras', 'Affiliation': 'Oral and Maxillofacial Surgery, Lithuanian University of Health Sciences, Kaunas, Lithuania.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Galindo-Moreno', 'Affiliation': 'Oral Surgery and Implant Dentistry Department, University of Granada, Granada, Andalucía, Spain.'}, {'ForeName': 'Gintaras', 'Initials': 'G', 'LastName': 'Januzis', 'Affiliation': 'Oral and Maxillofacial Surgery, Lithuanian University of Health Sciences, Kaunas, Lithuania.'}, {'ForeName': 'Gintaras', 'Initials': 'G', 'LastName': 'Juodzbalys', 'Affiliation': 'Oral and Maxillofacial Surgery, Lithuanian University of Health Sciences, Kaunas, Lithuania.'}]",Clinical implant dentistry and related research,['10.1111/cid.12950']
1637,33084215,Time trial of dry box laparoscopic surgical training improves laparoscopic surgical skills and surgical outcomes.,"INTRODUCTION


The present study assessed the utility of a dry box time trial during laparoscopic surgical training to improve laparoscopic surgical skills and surgical outcomes.
METHODS


In a monthly time trial, surgeon trainees twice completed a set task that involved grasping a suture, aligning a needle with a needle holder, passing the suture, making three knots, and cutting the two tails of the suture. The mean suturing time was then analyzed. To assess the utility of this time trial, we analyzed the short-term outcomes of patients with stage I to III colon cancer who had undergone laparoscopic colectomy before and after the introduction of the time trial.
RESULTS


The monthly time trial was introduced in October 2018, and 52 surgeon trainees participated in the trials examined in this study. Within 6 months of the program's introduction, the mean suturing time had significantly declined to less than 70% of the time trial, while the standard deviations had declined to less than 30%. In comparisons of the short-term outcomes of laparoscopic colon cancer surgery before (n = 49) and after (n = 46) the introduction of the time trial, the operative time tended to decline (P = .074) after the introduction of the time trial, and blood loss was significantly reduced (P = .018). The rate of postoperative complications was similar before and after the introduction.
CONCLUSION


Regular time trials of laparoscopic surgical suture training using a dry box can be useful for improving laparoscopic surgical skills and surgical outcomes. Moreover, time trials can keep trainees motivated.",2020,Regular time trials of laparoscopic surgical suture training using a dry box can be useful for improving laparoscopic surgical skills and surgical outcomes.,"['October 2018, and 52 surgeon trainees participated in the trials examined in this study', 'patients with stage']","['surgeon trainees twice completed a set task that involved grasping a suture, aligning a needle with a needle holder, passing the suture, making three knots, and cutting the two tails of the suture', 'laparoscopic colectomy', 'dry box laparoscopic surgical training', 'laparoscopic surgical training', 'laparoscopic surgical suture training']","['rate of postoperative complications', 'laparoscopic surgical skills and surgical outcomes', 'laparoscopic colon cancer surgery', 'blood loss', 'mean suturing time']","[{'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0220843', 'cui_str': 'Grasp'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C2369992', 'cui_str': 'Align'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0181952', 'cui_str': 'Needle holder'}, {'cui': 'C0560032', 'cui_str': 'knot'}, {'cui': 'C0000925', 'cui_str': 'Incised wound'}, {'cui': 'C0039259', 'cui_str': 'Tail'}, {'cui': 'C1517722', 'cui_str': 'Laparoscopic colectomy'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0006080', 'cui_str': 'Boxing'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0038969', 'cui_str': 'Surgical suture'}]","[{'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0007102', 'cui_str': 'Malignant tumor of colon'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.072545,Regular time trials of laparoscopic surgical suture training using a dry box can be useful for improving laparoscopic surgical skills and surgical outcomes.,"[{'ForeName': 'Yukiharu', 'Initials': 'Y', 'LastName': 'Hiyoshi', 'Affiliation': 'Department of Gastroenterological Surgery, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Miyamoto', 'Affiliation': 'Department of Gastroenterological Surgery, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan.'}, {'ForeName': 'Takahiko', 'Initials': 'T', 'LastName': 'Akiyama', 'Affiliation': 'Department of Gastroenterological Surgery, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan.'}, {'ForeName': 'Nobuya', 'Initials': 'N', 'LastName': 'Daitoku', 'Affiliation': 'Department of Gastroenterological Surgery, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Sakamoto', 'Affiliation': 'Department of Gastroenterological Surgery, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan.'}, {'ForeName': 'Ryuma', 'Initials': 'R', 'LastName': 'Tokunaga', 'Affiliation': 'Department of Gastroenterological Surgery, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan.'}, {'ForeName': 'Kojiro', 'Initials': 'K', 'LastName': 'Eto', 'Affiliation': 'Department of Gastroenterological Surgery, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan.'}, {'ForeName': 'Yohei', 'Initials': 'Y', 'LastName': 'Nagai', 'Affiliation': 'Department of Gastroenterological Surgery, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan.'}, {'ForeName': 'Masaaki', 'Initials': 'M', 'LastName': 'Iwatsuki', 'Affiliation': 'Department of Gastroenterological Surgery, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan.'}, {'ForeName': 'Shiro', 'Initials': 'S', 'LastName': 'Iwagami', 'Affiliation': 'Department of Gastroenterological Surgery, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan.'}, {'ForeName': 'Yoshifumi', 'Initials': 'Y', 'LastName': 'Baba', 'Affiliation': 'Department of Gastroenterological Surgery, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan.'}, {'ForeName': 'Naoya', 'Initials': 'N', 'LastName': 'Yoshida', 'Affiliation': 'Department of Gastroenterological Surgery, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan.'}, {'ForeName': 'Hideo', 'Initials': 'H', 'LastName': 'Baba', 'Affiliation': 'Department of Gastroenterological Surgery, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan.'}]",Asian journal of endoscopic surgery,['10.1111/ases.12871']
1638,33084254,"A Randomized, Placebo-Controlled Trial of Mirtazapine for the Treatment of Posttraumatic Stress Disorder in Veterans.","OBJECTIVE


The aim of this study was to determine the efficacy of mirtazapine, a tetracyclic antidepressant, as monotherapy for the treatment of posttraumatic stress disorder (PTSD).
METHODS


This multisite, randomized, double-blind, placebo-controlled trial was conducted between April 2006 and November 2010 at the Tuscaloosa and Birmingham Veterans Affairs Medical Centers in Alabama. US military veterans who met DSM-IV criteria for PTSD were randomly assigned to placebo (n = 39) or mirtazapine (n = 39) titrated up to 45 mg/d for an 8-week double-blind period followed by an 8-week open-label phase of mirtazapine treatment. The primary outcome efficacy measure was the Structured Interview for Posttraumatic Stress Disorder (SIP). Secondary measures included other measures of PTSD, depression, and sleep. Analyses of treatment groups involved mixed-model procedures using a random intercept to test the hypotheses that mirtazapine would be more effective than placebo in reducing symptoms of PTSD and depression and improving quality of sleep.
RESULTS


Seventy-eight participants were randomized with 61 completing the 8-week controlled phase and 48 completing the open-label phase. No significant differences were observed between groups on the primary outcome of SIP scores during the controlled phase (P = .418). In secondary outcomes, significant improvements per the Clinical Global Impressions-Improvement scale were found for the mirtazapine group compared to the placebo group (P = .041). The 8-week open-label phase demonstrated significant symptom improvement in SIP total score (P = .0003) and in scores on the SIP re-experiencing (P = .0007), avoidance (P = .0309), and hyperarousal (P = .0014) subscales. There were no significant differences in the occurrence of adverse events between groups.
CONCLUSIONS


This study did not show efficacy of mirtazapine monotherapy in the treatment of PTSD. Identification of more effective treatments, either as monotherapy or adjunctive, for PTSD is imperative.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT00302107.",2020,"The 8-week open-label phase demonstrated significant symptom improvement in SIP total score (P = .0003) and in scores on the SIP re-experiencing (P = .0007), avoidance (P = .0309), and hyperarousal (P = .0014) subscales.","['posttraumatic stress disorder (PTSD', 'April 2006 and November 2010 at the Tuscaloosa and Birmingham Veterans Affairs Medical Centers in Alabama', 'Seventy-eight participants were randomized with 61 completing the 8-week controlled phase and 48 completing the open-label phase', 'Posttraumatic Stress Disorder in Veterans', 'US military veterans who met DSM-IV criteria for PTSD']","['mirtazapine monotherapy', 'mirtazapine', 'Mirtazapine', 'placebo', 'mirtazapine treatment', 'Placebo']","['hyperarousal', 'occurrence of adverse events', 'Structured Interview for Posttraumatic Stress Disorder (SIP', 'Clinical Global Impressions-Improvement scale', 'symptoms of PTSD and depression and improving quality of sleep', 'measures of PTSD, depression, and sleep', 'SIP scores', 'SIP total score']","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0001895', 'cui_str': 'Alabama'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0521125', 'cui_str': 'For'}]","[{'cui': 'C0049506', 'cui_str': 'Mirtazapine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C4552570', 'cui_str': 'Hyperarousal'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",78.0,0.0597893,"The 8-week open-label phase demonstrated significant symptom improvement in SIP total score (P = .0003) and in scores on the SIP re-experiencing (P = .0007), avoidance (P = .0309), and hyperarousal (P = .0014) subscales.","[{'ForeName': 'Lori L', 'Initials': 'LL', 'LastName': 'Davis', 'Affiliation': 'VA Medical Center, 3701 Loop Rd East, Tuscaloosa, AL 35404. lori.davis@va.gov.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Pilkinton', 'Affiliation': 'Research and Development Service, VA Medical Center, Tuscaloosa, Alabama, USA.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Lin', 'Affiliation': 'Department of Neurology, Birmingham VA Medical Center, Birmingham, Alabama, USA.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Parker', 'Affiliation': 'Department of Psychiatry and Behavioral Neurobiology, University of Alabama School of Medicine, Birmingham, Alabama, USA.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Estes', 'Affiliation': 'Research and Development Service, VA Medical Center, Tuscaloosa, Alabama, USA.'}, {'ForeName': 'Al', 'Initials': 'A', 'LastName': 'Bartolucci', 'Affiliation': 'Department of Biostatistics, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}]",The Journal of clinical psychiatry,['10.4088/JCP.20m13267']
1639,33084335,Increased Intestinal Permeability in Older Subjects Impacts the Beneficial Effects of Dietary Polyphenols by Modulating Their Bioavailability.,"Polyphenols have great potential in regulating intestinal health and ameliorating pathological conditions related to increased intestinal permeability (IP). However, the efficacy of dietary interventions with these phytochemicals may significantly be influenced by interindividual variability factors affecting their bioavailability and consequent biological activity. In the present study, urine samples collected from older subjects undergoing a crossover intervention trial with polyphenol-rich foods were subjected to metabolomics analysis for investigating the impact of increased IP on the bioavailability of polyphenols. Interestingly, urinary levels of phase II and microbiota-derived metabolites were significantly different between subjects with healthier intestinal barrier integrity and those with increased IP disruption. Our results support that this IP-dependent impaired bioavailability of polyphenols could be attributed to disturbances in the gut microbial metabolism and phase II methylation processes. Furthermore, we also observed that microbiota-derived metabolites could be largely responsible for the biological activity elicited by dietary polyphenols against age-related disrupted IP.",2020,"Interestingly, urinary levels of phase II and microbiota-derived metabolites were significantly different between subjects with healthier intestinal barrier integrity and those with increased IP disruption.","['Older Subjects', 'older subjects undergoing a crossover intervention trial with']","['Polyphenols', 'Dietary Polyphenols', 'polyphenol-rich foods']","['Intestinal Permeability', 'urinary levels of phase II and microbiota-derived metabolites']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0071649', 'cui_str': 'Polyphenol'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0453861', 'cui_str': 'Rich food'}]","[{'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}, {'cui': 'C0243173', 'cui_str': 'urinary levels'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}]",,0.0234876,"Interestingly, urinary levels of phase II and microbiota-derived metabolites were significantly different between subjects with healthier intestinal barrier integrity and those with increased IP disruption.","[{'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Hidalgo-Liberona', 'Affiliation': 'Biomarkers and Nutrimetabolomics Laboratory, Department of Nutrition, Food Sciences and Gastronomy, Food Technology Reference Net (XaRTA), Nutrition and Food Safety Research Institute (INSA), Faculty of Pharmacy and Food Sciences, University of Barcelona, 08028 Barcelona, Spain.'}, {'ForeName': 'Raúl', 'Initials': 'R', 'LastName': 'González-Domínguez', 'Affiliation': 'Biomarkers and Nutrimetabolomics Laboratory, Department of Nutrition, Food Sciences and Gastronomy, Food Technology Reference Net (XaRTA), Nutrition and Food Safety Research Institute (INSA), Faculty of Pharmacy and Food Sciences, University of Barcelona, 08028 Barcelona, Spain.'}, {'ForeName': 'Esteban', 'Initials': 'E', 'LastName': 'Vegas', 'Affiliation': 'CIBER Fragilidad y Envejecimiento Saludable (CIBERfes), Instituto de Salud Carlos III, 28029 Barcelona, Spain.'}, {'ForeName': 'Patrizia', 'Initials': 'P', 'LastName': 'Riso', 'Affiliation': 'Università degli Studi di Milano, Department of Food, Environmental and Nutritional Sciences (DeFENS), 20133 Milano, Italy.'}, {'ForeName': 'Cristian', 'Initials': 'C', 'LastName': ""Del Bo'"", 'Affiliation': 'Università degli Studi di Milano, Department of Food, Environmental and Nutritional Sciences (DeFENS), 20133 Milano, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Bernardi', 'Affiliation': 'Università degli Studi di Milano, Department of Food, Environmental and Nutritional Sciences (DeFENS), 20133 Milano, Italy.'}, {'ForeName': 'Gregorio', 'Initials': 'G', 'LastName': 'Peron', 'Affiliation': 'Biomarkers and Nutrimetabolomics Laboratory, Department of Nutrition, Food Sciences and Gastronomy, Food Technology Reference Net (XaRTA), Nutrition and Food Safety Research Institute (INSA), Faculty of Pharmacy and Food Sciences, University of Barcelona, 08028 Barcelona, Spain.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Guglielmetti', 'Affiliation': 'Università degli Studi di Milano, Department of Food, Environmental and Nutritional Sciences (DeFENS), 20133 Milano, Italy.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Gargari', 'Affiliation': 'Università degli Studi di Milano, Department of Food, Environmental and Nutritional Sciences (DeFENS), 20133 Milano, Italy.'}, {'ForeName': 'Paul Antony', 'Initials': 'PA', 'LastName': 'Kroon', 'Affiliation': 'Quadram Institute Bioscience, Norwich Research Park, NR4 7UQ Norwich, United Kingdom.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Cherubini', 'Affiliation': ""Geriatria, Accettazione Geriatrica e Centro di Ricerca per l'Invecchiamento, IRCCS INRCA, 60127 Ancona, Italy.""}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Andrés-Lacueva', 'Affiliation': 'Biomarkers and Nutrimetabolomics Laboratory, Department of Nutrition, Food Sciences and Gastronomy, Food Technology Reference Net (XaRTA), Nutrition and Food Safety Research Institute (INSA), Faculty of Pharmacy and Food Sciences, University of Barcelona, 08028 Barcelona, Spain.'}]",Journal of agricultural and food chemistry,['10.1021/acs.jafc.0c04976']
1640,33084584,Feasibility and Acceptability of a Counseling- and mHealth-Based Physical Activity Intervention for Pregnant Women With Diabetes: The Fit for Two Pilot Study.,"BACKGROUND


Diabetes during pregnancy poses serious health risks to both mother and child. Regular physical activity can reduce these risks, yet few clinic-based interventions of physical activity for pregnant women with diabetes have been attempted.
OBJECTIVE


The purpose of this single-arm pilot trial is to assess the feasibility and acceptability, and explore the potential efficacy of a counseling- and mobile health-based physical activity intervention for pregnant women with diabetes.
METHODS


Participants (N=17) who had type 2 or gestational diabetes, could read and speak in English or Spanish, and were between 10 and 27 weeks of gestation were recruited from the University of California San Diego Diabetes and Pregnancy Program. Participants engaged in a one-on-one counseling and goal-setting session immediately following a clinic visit with their physician. They were given a Fitbit and shown how to use the Fitbit app, including entering personalized step goals, and were encouraged to build up to 10,000 daily steps. Daily steps were recorded for 12 weeks, until they were 36 weeks' gestation, or until 1 week before they gave birth, whichever came first. Feasibility was measured by recruitment, retention, and adherence, and acceptability was measured using consumer satisfaction questionnaires and follow-up interviews. Potential efficacy was explored by examining changes in daily steps over time.
RESULTS


The participants were primarily Hispanic (13/17, 76%), had public insurance (15/17, 88%), and had type 2 diabetes (12/17, 71%). Of the 17 patients who began the intervention, 76% (13/17) completed a follow-up visit, and 71% (12/17) continued wearing the Fitbit regularly after 8 weeks in the intervention. Adherence in wearing the Fitbit was relatively high, with a median wear adherence of 90% of days. The intervention was generally well accepted, with 85% (11/13) indicating that they were motivated to exercise more following the counseling session, 85% (11/13) indicating that the Fitbit helped increase their activity, and 92% (12/13) recommending the program overall. Mean daily steps increased from baseline (mean 6122, SD 2439) to week 3 (mean 6269, SD 2166) and then decreased through week 12 (mean 4191, SD 2228).
CONCLUSIONS


High acceptability, retention, and adherence suggest that this may be a promising approach to delivering a simple, low-burden intervention in a clinical setting to a high-risk, underserved population. A randomized controlled trial is needed to determine whether this approach is effective in slowing the reduction in activity typically seen throughout pregnancy.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03302377; https://clinicaltrials.gov/ct2/show/NCT03302377.",2020,"The intervention was generally well accepted, with 85% (11/13) indicating that they were motivated to exercise more following the counseling session, 85% (11/13) indicating that the Fitbit helped increase their activity, and 92% (12/13) recommending the program overall.","['17 patients who began the intervention, 76% (13/17) completed a follow-up visit, and 71% (12/17) continued wearing the Fitbit regularly after 8 weeks in the intervention', 'pregnant women with diabetes', 'Participants (N=17) who had type 2 or gestational diabetes, could read and speak in English or Spanish, and were between 10 and 27 weeks of gestation were recruited from the University of California San Diego Diabetes and Pregnancy Program', 'Pregnant Women With Diabetes', 'participants were primarily Hispanic (13/17, 76%), had public insurance (15/17, 88%), and had type 2 diabetes (12/17, 71', 'Participants engaged in a one-on-one counseling and goal-setting session immediately following a clinic visit with their physician']","['Counseling- and mHealth-Based Physical Activity Intervention', 'counseling- and mobile health-based physical activity intervention']","['Feasibility and Acceptability', 'recruitment, retention, and adherence, and acceptability', 'Potential efficacy', 'Mean daily steps', 'feasibility and acceptability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589121', 'cui_str': 'Follow-up visit'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0234856', 'cui_str': 'Speaking'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0021672', 'cui_str': 'Insurance'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0150598', 'cui_str': 'Goal setting'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}, {'cui': 'C0031831', 'cui_str': 'Physician'}]","[{'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}]",,0.063377,"The intervention was generally well accepted, with 85% (11/13) indicating that they were motivated to exercise more following the counseling session, 85% (11/13) indicating that the Fitbit helped increase their activity, and 92% (12/13) recommending the program overall.","[{'ForeName': 'Britta', 'Initials': 'B', 'LastName': 'Larsen', 'Affiliation': 'Department of Family Medicine & Public Health, University of California, San Diego, San Diego, CA, United States.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Micucci', 'Affiliation': 'Department of Family Medicine & Public Health, University of California, San Diego, San Diego, CA, United States.'}, {'ForeName': 'Sheri J', 'Initials': 'SJ', 'LastName': 'Hartman', 'Affiliation': 'Department of Family Medicine & Public Health, University of California, San Diego, San Diego, CA, United States.'}, {'ForeName': 'Gladys', 'Initials': 'G', 'LastName': 'Ramos', 'Affiliation': 'Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Diego, San Diego, CA, United States.'}]",JMIR mHealth and uHealth,['10.2196/18915']
1641,33084613,Similar Lung Function Impairment In Auto Mechanics Operating In Stand-alone Auto Repair and Auto Repair Shops Shared with Spray Painters.,"Automotive mechanics are reported to have lower lung function indices. Spray painting is associated with impairment of lung function among spray painters. It is a common practice by auto repairers in Calabar to operate in the vicinity of spray painting shops. Whether such dual exposure to auto repair and spray painting environments worsens the lung function of auto mechanics is not documented. Lung function was evaluated in 300 males divided into three groups: control (group1), auto mechanics in stand-alone auto repair shops (group 2) and auto mechanics working in the vicinity of spray painting shops (group 3). Each group consisted of 100 subjects. Forced vital capacity (FVC), forced expiratory volume in the first second (FEV1), peak expiratory flow rate (PEFR) and forced expiratory volume in the first second expressed as percentage of FVC (FEV1%) were assessed using a Vitalograph spirometer. Percentage oxygen saturation was evaluated using a pulse oximeter. Results showed no significant differences in age, weight and height among various groups. FVC was significantly reduced in groups 2 and 3 (p< 0.05 and p<0.001 respectively) compared to control but not between groups 2 and 3. FEV1 was significantly reduced in groups 2 and 3 (P <0.001 each) compared with control but not significantly different between groups 2 and 3. FEV1% was significantly lower in groups 2 and 3 (p< 0.001 each) compared with control but not between groups 2 and 3. The PEFR was significantly reduced in groups 2 and 3 (p<0.001 each) compared with control but not significantly different between groups 2 and 3. Percentage oxygen saturation was significantly reduced in groups 2 and 3 (p<0.05 and p<0.001 respectively) and also significantly lower in group 2 compared with group 3 (p<0.01). In conclusion, auto mechanics in auto repair only and auto repair shops shared with spray painters have lower lung function compared with control but no significant difference in lung function between auto mechanics in stand-alone auto repair shops compared with those in auto repair shops shared with spray painters.",2020,The PEFR was significantly reduced in groups 2 and 3 (p<0.001 each) compared with control but not significantly different between groups 2 and 3.,['300 males divided into three groups'],"['control (group1), auto mechanics in stand-alone auto repair\xa0shops (group 2) and auto mechanics working in the vicinity of spray painting shops', 'Auto Mechanics Operating In Stand-alone Auto Repair and Auto Repair Shops']","['Lung function', 'PEFR', 'Percentage oxygen saturation', 'FEV1', 'lung function', 'Forced vital capacity (FVC), forced expiratory volume in the first second (FEV1), peak expiratory flow rate (PEFR) and forced expiratory volume in the first second expressed as percentage of FVC (FEV1', 'Similar Lung Function Impairment', 'FVC']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0376706', 'cui_str': 'Mechanics'}, {'cui': 'C0560204', 'cui_str': 'Does stand alone'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0041472', 'cui_str': 'Murine typhus'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0557351', 'cui_str': 'Employed'}, {'cui': 'C1154182', 'cui_str': 'Spray dose form'}, {'cui': 'C0030208', 'cui_str': 'Paintings'}]","[{'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0030735', 'cui_str': 'Peak expiratory flow rate'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}]",300.0,0.0322002,The PEFR was significantly reduced in groups 2 and 3 (p<0.001 each) compared with control but not significantly different between groups 2 and 3.,"[{'ForeName': 'Ekpe', 'Initials': 'E', 'LastName': 'Aribo', 'Affiliation': 'University of Calabar. ekpearibo@gmail.com.'}]",Nigerian journal of physiological sciences : official publication of the Physiological Society of Nigeria,[]
1642,33084746,Maximal Oxygen Uptake and Ventilation Improvement Following Sacubitril-Valsartan Therapy.,"BACKGROUND


Sacubitril/valsartan had its prognosis benefit confirmed in the PARADIGM-HF trial. However, data on cardiopulmonary exercise testing (CPET) changes with sacubitril-valsartan therapy are scarce.
OBJECTIVE


This study aimed to compare CPET parameters before and after sacubitril-valsartan therapy.
METHODS


Prospective evaluation of chronic heart failure (HF) patients with left ventricular ejection fraction ≤40% despite optimized standard of care therapy, who started sacubitril-valsartan therapy, expecting no additional HF treatment. CPET data were gathered in the week before and 6 months after sacubitril-valsartan therapy. Statistical differences with a p-value <0.05 were considered significant.
RESULTS


Out of 42 patients, 35 (83.3%) completed the 6-month follow-up, since 2 (4.8%) patients died and 5 (11.9%) discontinued treatment for adverse events. Mean age was 58.6±11.1 years. New York Heart Association class improved in 26 (74.3%) patients. Maximal oxygen uptake (VO2max) (14.4 vs. 18.3 ml/kg/min, p<0.001), VE/VCO2slope (36.7 vs. 31.1, p<0.001), and exercise duration (487.8 vs. 640.3 sec, p<0.001) also improved with sacubitril-valsartan. Benefit was maintained even with the 24/26 mg dose (13.5 vs. 19.2 ml/kg/min, p=0.018) of sacubitril-valsartan, as long as this was the highest tolerated dose.
CONCLUSIONS


Sacubitril-valsartan therapy is associated with marked CPET improvement in VO2max, VE/VCO2slope, and exercise duration. (Arq Bras Cardiol. 2020; [online].ahead print, PP.0-0).",2020,"Maximal oxygen uptake (VO2max) (14.4 vs. 18.3 ml/kg/min, p<0.001), VE/VCO2slope (36.7 vs. 31.1, p<0.001), and exercise duration (487.8 vs. 640.3 sec, p<0.001) also improved with sacubitril-valsartan.","['chronic heart failure (HF) patients with left ventricular ejection fraction ≤40% despite optimized standard of care therapy, who started sacubitril-valsartan therapy, expecting no additional HF treatment']","['Sacubitril-Valsartan Therapy', 'sacubitril-valsartan', 'valsartan', 'sacubitril-valsartan therapy']","['Maximal Oxygen Uptake and Ventilation Improvement', 'VE/VCO2slope', 'exercise duration', 'Maximal oxygen uptake (VO2max', 'New York Heart Association class', 'marked CPET improvement in VO2max, VE/VCO2slope, and exercise duration']","[{'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C4033631', 'cui_str': 'valsartan and sacubitril'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C4033631', 'cui_str': 'valsartan and sacubitril'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0216784', 'cui_str': 'valsartan'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C2959886', 'cui_str': 'Cardiopulmonary exercise test'}]",42.0,0.0336562,"Maximal oxygen uptake (VO2max) (14.4 vs. 18.3 ml/kg/min, p<0.001), VE/VCO2slope (36.7 vs. 31.1, p<0.001), and exercise duration (487.8 vs. 640.3 sec, p<0.001) also improved with sacubitril-valsartan.","[{'ForeName': 'António Valentim', 'Initials': 'AV', 'LastName': 'Gonçalves', 'Affiliation': 'Hospital de Santa Marta, Lisboa - Portugal.'}, {'ForeName': 'Tiago', 'Initials': 'T', 'LastName': 'Pereira-da-Silva', 'Affiliation': 'Hospital de Santa Marta, Lisboa - Portugal.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Galrinho', 'Affiliation': 'Hospital de Santa Marta, Lisboa - Portugal.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Rio', 'Affiliation': 'Hospital de Santa Marta, Lisboa - Portugal.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Soares', 'Affiliation': 'Hospital de Santa Marta, Lisboa - Portugal.'}, {'ForeName': 'Joana', 'Initials': 'J', 'LastName': 'Feliciano', 'Affiliation': 'Hospital de Santa Marta, Lisboa - Portugal.'}, {'ForeName': 'Rita Ilhão', 'Initials': 'RI', 'LastName': 'Moreira', 'Affiliation': 'Hospital de Santa Marta, Lisboa - Portugal.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Silva', 'Affiliation': 'Hospital de Santa Marta, Lisboa - Portugal.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Alves', 'Affiliation': 'Hospital de Santa Marta, Lisboa - Portugal.'}, {'ForeName': 'Eunice', 'Initials': 'E', 'LastName': 'Capilé', 'Affiliation': 'Hospital de Santa Marta, Lisboa - Portugal.'}, {'ForeName': 'Rui Cruz', 'Initials': 'RC', 'LastName': 'Ferreira', 'Affiliation': 'Hospital de Santa Marta, Lisboa - Portugal.'}]",Arquivos brasileiros de cardiologia,['10.36660/abc.20190443']
1643,33066857,"Effectiveness and safety of electrical moxibustion for knee osteoarthritis: A multicenter, randomized, assessor-blinded, parallel-group clinical trial.","BACKGROUND


The prevalence of knee osteoarthritis (KOA) is increasing, and it has emerged as a major health issue. Studies have been reported that moxibustion is effective for treating KOA, but conventional moxibustion is difficult to control the intensity of stimulation and causes smoke, harmful gases, or odors. An electrical moxibustion (EM) device was developed to solve these problems, so we conducted this study to evaluate the effectiveness and safety of EM as a treatment for KOA.
METHODS


This is a multicenter, randomized, assessor-blinded, parallel-group clinical trial. Participants with KOA were randomly allocated into EM, traditional indirect moxibustion (TIM), or usual care groups. The moxibustion groups were received 12 sessions of moxibustion treatment at six acupuncture points (ST36, ST35, ST34, SP9, EX-LE4, SP10) over a period of 6 weeks. The usual care group was received usual treatment and self-care. The primary outcome was the degree of pain measured by numerical rating scale (NRS). The second outcomes were measured using visual analog scale, Korean version of the Western Ontario and McMaster Universities osteoarthritis index, patient global assessment, European quality of life five dimension five level scale, and warm sense threshold and heat pain threshold. For safety assessment, laboratory test and adverse events (AEs) were recorded.
RESULTS


A total of 138 participants were assigned. While there was no significant NRS change in the usual care, EM and TIM showed significant decrease after treatment. Compared to the usual care, the mean change of NRS in the EM and TIM was significantly different, but there was no significance between two groups. Regarding secondary outcomes, EM and TIM also showed significant difference compared to the usual care, but there was no significance between two groups. Regarding safety assessment, while usual care showed significant safety among three groups, EM showed seven treatment-related AEs by four participants compared TIM's 10 events by 10 participants. In addition, there was no blister caused by burns in the EM, which occurred four cases in the TIM.
CONCLUSION


This study shows that EM is effective to improve the pain and function by KOA with a certain level of safety.",2020,"Regarding secondary outcomes, EM and TIM also showed significant difference compared to the usual care, but there was no significance between two groups.","['A total of 138 participants were assigned', 'knee osteoarthritis', 'Participants with KOA']","['electrical moxibustion', 'electrical moxibustion (EM) device', 'EM, traditional indirect moxibustion (TIM), or usual care groups', 'moxibustion treatment at six acupuncture points (ST36, ST35, ST34, SP9, EX-LE4, SP10', 'usual treatment and self-care']","['For safety assessment, laboratory test and adverse events (AEs', 'Effectiveness and safety', 'visual analog scale, Korean version of the Western Ontario and McMaster Universities osteoarthritis index, patient global assessment, European quality of life five dimension five level scale, and warm sense threshold and heat pain threshold', 'degree of pain measured by numerical rating scale (NRS', 'mean change of NRS in the EM and TIM']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}]","[{'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0026652', 'cui_str': 'Moxibustion'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0439852', 'cui_str': 'Indirect'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001302', 'cui_str': 'Acupuncture point'}, {'cui': 'C0450533', 'cui_str': 'ST36'}, {'cui': 'C0450532', 'cui_str': 'ST35'}, {'cui': 'C0450531', 'cui_str': 'ST34'}, {'cui': 'C0450551', 'cui_str': 'SP9'}, {'cui': 'C0450552', 'cui_str': 'SP10'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0026652', 'cui_str': 'Moxibustion'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0439852', 'cui_str': 'Indirect'}]",138.0,0.0803553,"Regarding secondary outcomes, EM and TIM also showed significant difference compared to the usual care, but there was no significance between two groups.","[{'ForeName': 'Ha-Ra', 'Initials': 'HR', 'LastName': 'Kang', 'Affiliation': 'Department of Korean Medicine, Dongguk University Graduate School, Goyang, Republic of Korea. Electronic address: gkfk29@hanmail.net.'}, {'ForeName': 'Yeon-Sun', 'Initials': 'YS', 'LastName': 'Lee', 'Affiliation': 'Department of Acupuncture & Moxibustion, Dongguk University Ilsan Oriental Hospital, Goyang, Republic of Korea. Electronic address: ewslys@naver.com.'}, {'ForeName': 'Seon-Hye', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'Department of Acupuncture & Moxibustion, Dongguk University Bundang Oriental Hospital, Seongnam, Republic of Korea. Electronic address: seonhye620@hanmail.net.'}, {'ForeName': 'Won-Suk', 'Initials': 'WS', 'LastName': 'Sung', 'Affiliation': 'Department of Acupuncture & Moxibustion, Dongguk University Bundang Oriental Hospital, Seongnam, Republic of Korea. Electronic address: 1984sws@hanmail.net.'}, {'ForeName': 'Chan-Yung', 'Initials': 'CY', 'LastName': 'Jung', 'Affiliation': 'Institute of Oriental Medicine, College of Korean Medicine, Dongguk University, Goyang, Republic of Korea. Electronic address: yyoung81@hanmail.net.'}, {'ForeName': 'Hyun-Seok', 'Initials': 'HS', 'LastName': 'Cho', 'Affiliation': 'Department of Acupuncture & Moxibustion, Dongguk University Bundang Oriental Hospital, Seongnam, Republic of Korea. Electronic address: good-doctor@hanmail.net.'}, {'ForeName': 'Seung-Deok', 'Initials': 'SD', 'LastName': 'Lee', 'Affiliation': 'Institute of Oriental Medicine, College of Korean Medicine, Dongguk University, Goyang, Republic of Korea. Electronic address: chunkman@dongguk.edu.'}, {'ForeName': 'Kyung-Ho', 'Initials': 'KH', 'LastName': 'Kim', 'Affiliation': 'Department of Acupuncture & Moxibustion, Dongguk University Ilsan Oriental Hospital, Goyang, Republic of Korea. Electronic address: omdkkh@hanmail.net.'}, {'ForeName': 'Eun-Jung', 'Initials': 'EJ', 'LastName': 'Kim', 'Affiliation': 'Department of Acupuncture & Moxibustion, Dongguk University Bundang Oriental Hospital, Seongnam, Republic of Korea. Electronic address: hanijjung@naver.com.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102523']
1644,33066859,Evaluation of the effect of vitamin D3 supplementation on quantitative and qualitative parameters of spermograms and hormones in infertile men: A Randomized controlled trial.,"BACKGROUND


25-Hydroxy Vitamin D3 is known to have an effect on reproductive system in both genders and may change the semen parameters in men.
OBJECTIVE


Our study aimed to evaluate the effect of oral vitamin D3 supplementation on spermogram quantitative and qualitative parameters in infertile men.
MATERIALS AND METHODS


This study was a triple-blind randomized controlled trial involving 62 infertile men with impaired spermatogonial tests. They were randomly divided into placebo and D3-supplemented groups. Spermograms and tests for LH (Luteinizing Hormone), FSH (Follicle Stimulating Hormone), TT (Total Testosterone), FT (Free Testosterone), SHBG (Sex Hormone Bonding Globulin), FAI (Free Androgen Index) and vitamin D3 levels were performed before and after the intervention.
RESULTS


There were no significant differences between the two groups in parameters of the spermograms or serum levels of LH, FSH, TT, and FAI. In the intervention group, SHBG was significantly decreased after intervention (p = 0.01) and there was a significant increase in FT in the placebo group (p = 0.03).
CONCLUSION


The intake of vitamin D3 did not change the quality and quantity of spermograms and serum levels of LH, FSH, TT, and FAI but affected FT and SHBG. Further studies are still needed to clarify the biological role of vitamin D3 on fertility particularly on male fertility. This study lays a foundation for more extensive studies on male infertility.",2020,"The intake of vitamin D3 did not change the quality and quantity of spermograms and serum levels of LH, FSH, TT, and FAI but affected FT and SHBG.","['men', 'male infertility', 'infertile men', '62 infertile men with impaired spermatogonial tests']","['oral vitamin D3 supplementation', 'LH', 'vitamin D3', 'placebo', 'vitamin D3 supplementation']","['quality and quantity of spermograms and serum levels of LH, FSH, TT, and FAI but affected FT and SHBG', 'spermogram quantitative and qualitative parameters', 'FT', 'Luteinizing Hormone), FSH (Follicle Stimulating Hormone), TT (Total Testosterone), FT (Free Testosterone), SHBG (Sex Hormone Bonding Globulin), FAI (Free Androgen Index) and vitamin D3 levels', 'spermograms or serum levels of LH, FSH, TT, and FAI', 'SHBG']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0021364', 'cui_str': 'Male infertility'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0202022', 'cui_str': 'Follicle stimulating hormone measurement'}, {'cui': 'C0428629', 'cui_str': 'Free androgen index measurement'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0036883', 'cui_str': 'Sex steroid binding globulin'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0205556', 'cui_str': 'Qualitative'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0733758', 'cui_str': 'Follicle Stimulating Hormone'}, {'cui': 'C0202227', 'cui_str': 'Testosterone measurement, total'}, {'cui': 'C0202228', 'cui_str': 'Testosterone measurement, unbound'}, {'cui': 'C0036884', 'cui_str': 'Sex hormone'}, {'cui': 'C0017649', 'cui_str': 'Globulin'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}]",62.0,0.172834,"The intake of vitamin D3 did not change the quality and quantity of spermograms and serum levels of LH, FSH, TT, and FAI but affected FT and SHBG.","[{'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Amini', 'Affiliation': 'Department of Midwifery, School of Nursing and Midwifery, Iran University of Medical Sciences, Tehran, Iran. Electronic address: amini.l@iums.ac.ir.'}, {'ForeName': 'Robabe', 'Initials': 'R', 'LastName': 'Mohammadbeigi', 'Affiliation': 'Clinical Research Development Unit (ShACkRDU), Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Vafa', 'Affiliation': 'School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Haghani', 'Affiliation': 'Department of Biostatistics, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Vahedian-Azimi', 'Affiliation': 'Trauma Research Center, Nursing Faculty, Baqiyatallah University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Karimi', 'Affiliation': 'Behavioral Sciences Research Center, Life Style Institute, Nursing Faculty, Baqiyatallah University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shayesteh', 'Initials': 'S', 'LastName': 'Jahanfar', 'Affiliation': 'MPH Program, Central Michigan University, USA.'}, {'ForeName': 'Tannaz', 'Initials': 'T', 'LastName': 'Jamialahmadi', 'Affiliation': 'Biotechnology Research Center, Pharmaceutical Technology Institute, Mashhad University of Medical Sciences, Mashhad, Iran; Department of Food Science and Technology, Quchan Branch, Islamic Azad University, Quchan, Iran; Department of Nutrition, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Afsaneh', 'Initials': 'A', 'LastName': 'Talebi', 'Affiliation': 'Department of Midwifery, School of Nursing and Midwifery, Iran University of Medical Sciences, Tehran, Iran. Electronic address: afsanehtalebi68@gmail.com.'}, {'ForeName': 'Amirhossein', 'Initials': 'A', 'LastName': 'Sahebkar', 'Affiliation': ""Halal Research Center of IRI, FDA, Tehran, Iran; Neurogenic Inflammation Research Center, Mashhad University of Medical Sciences, Mashhad, Iran; Biotechnology Research Center, Pharmaceutical Technology Institute, Mashhad University of Medical Sciences, Mashhad 9177948564, Iran; Polish Mother's Memorial Hospital Research Institute (PMMHRI), 93338 Lodz, Poland. Electronic address: sahebkara@mums.ac.ir.""}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102529']
1645,33066862,Efficacy of Nardostachys jatamansi (D.Don) DC in essential hypertension: A randomized controlled study.,"BACKGROUND


Nardostachys jatamansi (D.Don) DC, commonly known as muskroot and Indian spikenard, is a small, perennial, flowering, rhizomatous species of the Caprifoliaceae family. Nardostachys jatamansi (D.Don) DC (Sumbul-ut-teeb) has been used in Unani Medicine since antiquity. It is one of the important drugs mentioned by Ibn-e-Sina (Avicenna) in his treatise ""Kitab al-Adwiya al- Qalbiya"" for cardiac diseases. The drug has been shown to exhibit anxiolytic, sedative, antispasmodic, tranquillizing, and anti hypertensive activity.
AIM


The aim of the present study was to examine the efficacy of Nardostachys jatamansi in reducing blood pressure in hypertensive patients.
METHODS


The single blind randomized, placebo controlled study was conducted with 40 patients aged between 35-70 years. The participants were randomly allocated to receive either a total of 3 g of N. Jatamansi (1capsule 3 times a day) or placebo for 4 weeks. Patients using ≤ 2 antihypertensive drugs with stage 1 hypertension were included in the study. Systolic and diastolic Blood pressure was recorded at baseline and at every week for four weeks. MINICHAL score (for Quality of Life) was recorded at baseline and at the end of the trial.
RESULTS


After the four weeks of treatment, there was a statistically significant reduction in average systolic blood pressure 144.20 ± 11.35 mmHg (CI, 138.89-149.51) to 134.30 ± 10.08 mmHg (CI, 129.58-139.02), p < 0.001) and diastolic blood pressure (94.9. ± 3.4 mmHg (CI 93.30-96.49) to 83.10 ± 5.29 mmHg (CI 80.62-85.57), p < 0.001) in the N. Jatamansi group whereas there was no significant difference in systolic blood pressure (143.40 ± 8.39 mmHg (CI, 139.47-147.33) to 142. ± 11.68 mmHg (CI, 136.53-147.47) p = 0.148) and diastolic blood pressure 95.10 ± 3.70 mmHg (CI, 93.37-96.83) to 94.80 ± 3.69 mmHg, (CI93.07-96.52) p = 0.186) in placebo group. A comparison between baseline and post treatment, MINICHAL score in N. Jatamansi group showed significant reduction 10.85 ± 1.27 (CI, 10.25-11.44) to 6.20 ± 1.77, (CI, 5.37-7.02) p < 0.001) whereas there was no significant difference in placebo group 11.05 ± 1.50 (CI, 10.34-11.75) to 10.85 ± 1.26, 95 % (CI, 10.25-11.44) p = 0.103).
CONCLUSION


The present findings suggest that N. Jatamansi is effective in reducing both systolic and diastolic blood pressure in essential hypertension. Moreover studies on efficacy of different doses and treatment duration of test drug are required to finetune these observations.",2020,"After the four weeks of treatment, there was a statistically significant reduction in average systolic blood pressure 144.20 ± 11.35 mmHg (CI, 138.89-149.51) to 134.30 ± 10.08 mmHg (CI, 129.58-139.02), p < 0.001) and diastolic blood pressure (94.9. ± 3.4 mmHg (CI 93.30-96.49) to 83.10 ± 5.29 mmHg (CI 80.62-85.57), p < 0.001) in the N. Jatamansi group whereas there was no significant difference in systolic blood pressure (143.40 ± 8.39 mmHg (CI, 139.47-147.33) to 142.","['Patients using ≤ 2 antihypertensive drugs with stage 1 hypertension were included in the study', '40 patients aged between 35-70 years', 'essential hypertension', 'hypertensive patients']","['Nardostachys jatamansi', 'placebo', 'Nardostachys jatamansi (D.Don) DC']","['systolic and diastolic blood pressure', 'blood pressure', 'systolic blood pressure', 'Systolic and diastolic Blood pressure', 'diastolic blood pressure', 'average systolic blood pressure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0085580', 'cui_str': 'Essential hypertension'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}]","[{'cui': 'C1021351', 'cui_str': 'Nardostachys'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C1282151', 'cui_str': 'Average systolic blood pressure'}]",40.0,0.25321,"After the four weeks of treatment, there was a statistically significant reduction in average systolic blood pressure 144.20 ± 11.35 mmHg (CI, 138.89-149.51) to 134.30 ± 10.08 mmHg (CI, 129.58-139.02), p < 0.001) and diastolic blood pressure (94.9. ± 3.4 mmHg (CI 93.30-96.49) to 83.10 ± 5.29 mmHg (CI 80.62-85.57), p < 0.001) in the N. Jatamansi group whereas there was no significant difference in systolic blood pressure (143.40 ± 8.39 mmHg (CI, 139.47-147.33) to 142.","[{'ForeName': 'Muzafar Din Ahmad', 'Initials': 'MDA', 'LastName': 'Bhat', 'Affiliation': 'Dept. of Moalajat (Medicine), National Institute of Unani Medicine Bangalore 560091, India. Electronic address: drmuzaffar79@gmail.com.'}, {'ForeName': 'Shah Agaz', 'Initials': 'SA', 'LastName': 'Malik', 'Affiliation': 'Dept. of Moalajat (Medicine), National Institute of Unani Medicine Bangalore 560091, India. Electronic address: draghaz.malik@gmail.com.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102532']
1646,33066865,Tai Chi training for attention deficit hyperactivity disorder: A feasibility trial in college students.,"OBJECTIVE


Many young adults are affected by attention deficit hyperactivity disorder (ADHD) and often desire non-pharmacological treatment options. Mind-body techniques might serve as complementary therapies to first-line stimulant medications, but studies are limited. Tai Chi is an increasingly popular practice that integrates movement with cognitive skills relevant to ADHD. We performed a feasibility trial of Tai Chi training in undergraduates to inform the design of a fully powered randomized controlled trial (RCT).
METHOD


Undergraduates with ADHD were recruited, screened, enrolled, and assessed at baseline. They were assigned to three parallel seven-week intervention arms, Tai Chi, Active Control (cardio-aerobic fitness), and Inactive Control (no contact), with follow-up assessments. Feasibility of a larger clinical trial was evaluated, especially with respect to enrollment and retention. Additionally, potential clinical outcome measures were examined for practicality and reliability.
RESULTS


21 participants were assessed at baseline and 19 at follow-up (90 % retention). The primary clinical outcome measure, self-reported inattention symptoms (Conners' CAARS-S:L DSM-IV Inattentive Symptoms subscale), exhibited good test-retest reliability in controls (r = 0.87, n = 10) and correlated with reduced mindfulness (FFMQ acting with awareness subscale) at baseline (r = -0.74, n = 20). Class attendance and self-reported daily practice time were variable. Randomization to group classes was hindered by the college students' restricted schedules.
CONCLUSION


The high retention rate and good data quality suggest that an RCT of Tai Chi for ADHD is feasible. Further measures are identified to improve enrollment rates, adherence, and randomization procedures. Future work might extend to other young adult populations and high school students.",2020,"They were assigned to three parallel seven-week intervention arms, Tai Chi, Active Control (cardio-aerobic fitness), and Inactive Control (no contact), with follow-up assessments.","['college students', 'attention deficit hyperactivity disorder', 'young adults', 'young adult populations and high school students', 'Undergraduates with ADHD were recruited, screened, enrolled, and assessed at baseline']","['Tai Chi, Active Control (cardio-aerobic fitness), and Inactive Control (no contact), with follow-up assessments', 'Tai Chi training']","[""self-reported inattention symptoms (Conners' CAARS-S:L DSM-IV Inattentive Symptoms subscale), exhibited good test-retest reliability"", 'Class attendance and self-reported daily practice time', 'practicality and reliability', 'reduced mindfulness (FFMQ acting with awareness subscale']","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]","[{'cui': 'C0376403', 'cui_str': 'Tai-chi'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0424101', 'cui_str': 'Inattention'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0015272', 'cui_str': 'Exhibits as Topic'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}]",21.0,0.0515994,"They were assigned to three parallel seven-week intervention arms, Tai Chi, Active Control (cardio-aerobic fitness), and Inactive Control (no contact), with follow-up assessments.","[{'ForeName': 'Alexander K', 'Initials': 'AK', 'LastName': 'Converse', 'Affiliation': 'Waisman Center, University of Wisconsin-Madison, United States. Electronic address: akconverse@wisc.edu.'}, {'ForeName': 'Bruce P', 'Initials': 'BP', 'LastName': 'Barrett', 'Affiliation': 'Department of Family Medicine and Community Health, University of Wisconsin-Madison, United States.'}, {'ForeName': 'Betty A', 'Initials': 'BA', 'LastName': 'Chewning', 'Affiliation': 'School of Pharmacy, University of Wisconsin-Madison, United States.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Wayne', 'Affiliation': ""Osher Center for Integrative Medicine, Harvard Medical School and Brigham and Women's Hospital, United States.""}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102538']
1647,33068342,[Acupuncture technique of  Jingou Diaoyu  combined with speech rehabilitation training for post-stroke motor aphasia].,"OBJECTIVE


To compare the clinical efficacy of the acupuncture technique of  Jingou Diaoyu  combined with speech rehabilitation training and speech rehabilitation training alone for post-stroke motor aphasia.
METHODS


A total of 70 patients with post-stroke motor aphasia were randomly divided into an observation group and a control group, 35 cases in each group. The patients in the control group were treated with basic treatment and speech rehabilitation training; on the basis of the control group, the patients in the observation group were treated with the acupuncture technique of  Jingou Diaoyu  at Yamen (GV 15), Jinjin (EX-HN 12), Yuye (EX-HN 13), and Hegu (LI 4) etc., once a day, 6 days per week, for a total of 4 weeks. The speech function score, aphasia grade, daily life speech ability score of the two groups before and after treatment were observed, and the clinical efficacy was evaluated.
RESULTS


The total effective rate was 94.3% (33/35) in the observation group, which was superior to 80.0% (28/35) in the control group ( P <0.05). In addition to listening comprehension, each score of speech function in the two groups was significantly increased after treatment ( P <0.05), and the increasing in the observation group was greater than that in the control group ( P <0.05). After treatment, the aphasia grade of the two groups were improved ( P <0.05), and the aphasia grade in the observation group was significantly better than that in the control group ( P <0.05). After treatment, the scores of daily life speech ability in the two groups were significantly improved ( P <0.05), and the increasing in the observation group was greater than that in the control group ( P <0.05).
CONCLUSION


The acupuncture technique of  Jingou Diaoyu  combined with speech rehabilitation training could improve the speech function of patients with post-stroke motor aphasia, and its curative effect is superior to the speech rehabilitation training alone.",2020,"After treatment, the scores of daily life speech ability in the two groups were significantly improved ( P <0.05), and the increasing in the observation group was greater than that in the control group ( P <0.05).
","['70 patients with post-stroke motor aphasia', 'patients with post-stroke motor aphasia', 'post-stroke motor aphasia']","['acupuncture technique of  Jingou Diaoyu  at Yamen (GV 15), Jinjin (EX-HN 12), Yuye (EX-HN 13), and Hegu', 'basic treatment and speech rehabilitation training', 'Acupuncture technique of  Jingou Diaoyu  combined with speech rehabilitation training', 'acupuncture technique of  Jingou Diaoyu  combined with speech rehabilitation training and speech rehabilitation training alone', 'speech rehabilitation training']","['total effective rate', 'clinical efficacy', 'scores of daily life speech ability', 'score of speech function', 'speech function score, aphasia grade, daily life speech ability score', 'speech function', 'aphasia grade']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0003550', 'cui_str': 'Motor aphasia'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0919925', 'cui_str': 'Speech rehabilitation'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0003537', 'cui_str': 'Aphasia'}, {'cui': 'C0441800', 'cui_str': 'Grade'}]",70.0,0.0230044,"After treatment, the scores of daily life speech ability in the two groups were significantly improved ( P <0.05), and the increasing in the observation group was greater than that in the control group ( P <0.05).
","[{'ForeName': 'Chao-Zhan', 'Initials': 'CZ', 'LastName': 'Ren', 'Affiliation': 'First Department of Acupuncture and Moxibustion, Gansu Hospital of TCM, Lanzhou 730050, China.'}, {'ForeName': 'Xi-Yan', 'Initials': 'XY', 'LastName': 'Lv', 'Affiliation': 'Department of Rehabilitation Medicine, Gansu Hospital of TCM, Lanzhou 730050, China.'}, {'ForeName': 'Xi-Juan', 'Initials': 'XJ', 'LastName': 'Zhang', 'Affiliation': 'Department of Rehabilitation Therapy, Gansu Rehabilitation Center Hospital.'}, {'ForeName': 'Xing-Hua', 'Initials': 'XH', 'LastName': 'Zhang', 'Affiliation': 'First Department of Acupuncture and Moxibustion, Gansu Hospital of TCM, Lanzhou 730050, China.'}, {'ForeName': 'Hong-Tao', 'Initials': 'HT', 'LastName': 'Zhang', 'Affiliation': 'First Department of Acupuncture and Moxibustion, Gansu Hospital of TCM, Lanzhou 730050, China.'}]",Zhongguo zhen jiu = Chinese acupuncture & moxibustion,['10.13703/j.0255-2930.20190811-k0002']
1648,33068343,[Impact of abdominal moxibustion in a period of day from 7 am to 9 am on improvement in post-stroke lower limb spasticity and muscle architecture parameter].,"OBJECTIVE


To compare the therapeutic effect on post-stroke lower limb spasticity between the combined treatment of abdominal moxibustion from 7 am to 9 am and rehabilitation training and the simple rehabilitation training.
METHODS


A total of 100 patients with post-stroke lower limb spasticity were randomized into an observation group (50 cases, 3 cases dropped off) and a control group (50 cases, 4 cases dropped off ). In the control group, the basic treatment of internal medicine and rehabilitation training of the limbs were adopted. In the observation group, on the basis of the treatment in the control group, at the time zone from 7 am to 9 am, moxibustion on the abdomen with ""eight-trigram"" moxa box [the central moxa box accurately facing Shenque (CV 8)] was given, lasting for 2 h, once every two days. Both groups were treated for 6 weeks. Separately, before and after treatment, the score of Fugl-Meyer assessment of the lower extremity (FMA-LE) and the grade of modified Ashworth scale (MAS) of ankle joint were evaluated on the affected side in patients of the two groups. Muscle skeleton ultrasound (MSUS) was adopted to determine the first layer muscle thickness (MT) anterior to the tibia, the number of pennation angle (PA) and the length of muscle fibers in the medial head of gastrocnemius muscle on the affected side. Besides, after treatment, the therapeutic effect was evaluated in the two groups.
RESULTS


After treatment, the score of FMA-LE and the grade of MAS of ankle joint on the affected side were both improved as compared with those before treatment in patients of the two groups ( P <0.01,  P <0.05). The improvements in the observation group were better than those in the control group ( P <0.01,  P <0.05). After treatment, MT anterior to the tibia, the number of PA and the length of muscle fibers in the medial head of gastrocnemius muscle on the affected side were all increased as compared with before treatment in patients of the two groups ( P <0.01). The increase degree in the observation group was larger than that in the control group ( P <0.01). The total effective rate was 93.6% (44/47) in the observation group, better than 80.4% (37/46) in the control group ( P <0.05).
CONCLUSION


The combined treatment of abdominal moxibustion from 7 am to 9 am and rehabilitation training effectively relieves post-stroke lower limb spasticity and improves the limb functions and muscle structure. The total effective rate of this combined treatment is better than that of simple rehabilitation training.",2020,"The improvements in the observation group were better than those in the control group ( P <0.01,  P <0.05).",['100 patients with post-stroke lower limb spasticity'],"['Muscle skeleton ultrasound (MSUS', 'abdominal moxibustion', 'abdominal moxibustion from 7 am to 9 am and rehabilitation training and the simple rehabilitation training', 'abdominal moxibustion from 7 am to 9 am and rehabilitation training']","['limb functions and muscle structure', 'therapeutic effect', 'total effective rate', 'score of Fugl-Meyer assessment of the lower extremity (FMA-LE) and the grade of modified Ashworth scale (MAS) of ankle joint', 'score of FMA-LE and the grade of MAS of ankle joint', 'number of PA and the length of muscle fibers in the medial head of gastrocnemius muscle on the affected side']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C1271100', 'cui_str': 'Lower limb spasticity'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0037253', 'cui_str': 'Skeletal system structure'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0026652', 'cui_str': 'Moxibustion'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205352', 'cui_str': 'Simple'}]","[{'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1305763', 'cui_str': 'Muscle structure'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C4707572', 'cui_str': 'Modified Ashworth Scale'}, {'cui': 'C0003087', 'cui_str': 'Ankle joint structure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0224460', 'cui_str': 'Structure of medial head of gastrocnemius muscle'}, {'cui': 'C0392760', 'cui_str': 'Affecting'}]",100.0,0.0224451,"The improvements in the observation group were better than those in the control group ( P <0.01,  P <0.05).","[{'ForeName': 'Zi-Han', 'Initials': 'ZH', 'LastName': 'Lin', 'Affiliation': 'Department of Acupuncture-Moxibustion and Rehabilitation, Quanzhou Hospital of TCM Affiliated to Fujian University of TCM, Quanzhou 362000, China.'}, {'ForeName': 'Chuan-Liang', 'Initials': 'CL', 'LastName': 'Ruan', 'Affiliation': 'Department of Acupuncture-Moxibustion and Rehabilitation, Quanzhou Hospital of TCM Affiliated to Fujian University of TCM, Quanzhou 362000, China.'}, {'ForeName': 'Wen-Qiang', 'Initials': 'WQ', 'LastName': 'Zhou', 'Affiliation': 'Department of Acupuncture-Moxibustion and Rehabilitation, Quanzhou Hospital of TCM Affiliated to Fujian University of TCM, Quanzhou 362000, China.'}, {'ForeName': 'Li-Rong', 'Initials': 'LR', 'LastName': 'Zeng', 'Affiliation': 'Department of Acupuncture-Moxibustion and Rehabilitation, Quanzhou Hospital of TCM Affiliated to Fujian University of TCM, Quanzhou 362000, China.'}, {'ForeName': 'Chun-Yan', 'Initials': 'CY', 'LastName': 'Chen', 'Affiliation': 'Department of Acupuncture-Moxibustion and Rehabilitation, Quanzhou Hospital of TCM Affiliated to Fujian University of TCM, Quanzhou 362000, China.'}, {'ForeName': 'Ping-Ping', 'Initials': 'PP', 'LastName': 'Zeng', 'Affiliation': 'Department of Acupuncture-Moxibustion and Rehabilitation, Quanzhou Hospital of TCM Affiliated to Fujian University of TCM, Quanzhou 362000, China.'}]",Zhongguo zhen jiu = Chinese acupuncture & moxibustion,['10.13703/j.0255-2930.20190904-k0001']
1649,33067293,"School-based, two-arm, parallel, controlled trial of a culturally adapted resilience intervention to improve adolescent mental health in Vietnam: study protocol.","INTRODUCTION


The Resourceful Adolescent Program (RAP) is an evidence-based resilience intervention for adolescents. Operating in a strength-focused paradigm, the programme uses an integration of cognitive behavioural therapy and interpersonal psychotherapy to improve coping skills and build resilience. This study aims to establish whether a culturally and linguistically adapted intervention informed by RAP principles is effective in increasing resilience, enhancing coping skills and preventing symptoms of depression and anxiety.
METHODS AND ANALYSIS


We will translate, back-translate and culturally adapt the RAP for adolescents and training materials for facilitators, and the adapted intervention will be called Happy House. A two-arm parallel controlled trial will be conducted in eight high schools in the north of Vietnam. In each of the selected schools, all students from four randomly selected grade 10 classes (an estimation of about 1204 students) will be invited to participate. The control group will receive the usual curriculum. The intervention group will receive six weekly 90 min school-based group sessions of Happy House in addition to the usual curriculum. The primary outcome, depressive symptoms, will be measured using a locally validated version of the Centre for Epidemiologic Studies Depression Scale Revised. Secondary outcomes are mental well-being, coping self-efficacy, school connectedness, anger management and health risk behaviours. Data will be collected at recruitment, and at two weeks and six months post intervention. Mixed-effect logistic regression for the main outcome and mixed-effect linear and logistic regression models for the secondary outcomes will be conducted to estimate the effects of the intervention on the outcomes.
ETHICS AND DISSEMINATION


This trial has been approved by Monash University Human Research Ethics Committee (No. 21455) and the Institutional Review Board of the Hanoi School of Public Health (488/2019/YTCC-HD3). Dissemination of findings will include peer-reviewed publications, international and national conferences, seminar and media presentations, national policy briefings in Vietnam, local language reports and lay language summaries for participants.
TRIAL REGISTRATION NUMBERS


Registered with the Australian New Zealand Clinical Trials Registry, registration number: ACTRN12620000088943 (3/2/2020).WHO Universal Trial Number: U1111-1246-4079.",2020,"The primary outcome, depressive symptoms, will be measured using a locally validated version of the Centre for Epidemiologic Studies Depression Scale Revised.","['adolescent mental health in Vietnam', 'adolescents', 'eight high schools in the north of Vietnam', 'selected schools, all students from four randomly selected grade 10 classes (an estimation of about 1204 students']","['culturally adapted resilience intervention', 'cognitive behavioural therapy and interpersonal psychotherapy', 'Resourceful Adolescent Program (RAP']","['mental well-being, coping self-efficacy, school connectedness, anger management and health risk behaviours', 'depressive symptoms, will be measured using a locally validated version of the Centre for Epidemiologic Studies Depression Scale Revised']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0042658', 'cui_str': 'Vietnam'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}]","[{'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0871787', 'cui_str': 'Interpersonal psychotherapy'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0557992', 'cui_str': 'Anger management therapy'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0002783', 'cui_str': 'Studies, Epidemiologic'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}]",4.0,0.126691,"The primary outcome, depressive symptoms, will be measured using a locally validated version of the Centre for Epidemiologic Studies Depression Scale Revised.","[{'ForeName': 'Thach', 'Initials': 'T', 'LastName': 'Tran', 'Affiliation': ""Global and Women's Health, Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.""}, {'ForeName': 'Huong Thanh', 'Initials': 'HT', 'LastName': 'Nguyen', 'Affiliation': 'Department of Health Education, Faculty of Social Science, Behavior and Health Education, Hanoi University of Public Health, Hanoi, Vietnam.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Shochet', 'Affiliation': 'School of Psychology and Counselling, Queensland University of Technology, Brisbane, Queensland, Australia.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Wurfl', 'Affiliation': 'School of Psychology and Counselling, Queensland University of Technology, Brisbane, Queensland, Australia.'}, {'ForeName': 'Jayne', 'Initials': 'J', 'LastName': 'Orr', 'Affiliation': 'School of Psychology and Counselling, Queensland University of Technology, Brisbane, Queensland, Australia.'}, {'ForeName': 'Nga', 'Initials': 'N', 'LastName': 'Nguyen', 'Affiliation': 'Department of Health Education, Faculty of Social Science, Behavior and Health Education, Hanoi University of Public Health, Hanoi, Vietnam.'}, {'ForeName': 'Nga', 'Initials': 'N', 'LastName': 'La', 'Affiliation': 'Department of Health Education, Faculty of Social Science, Behavior and Health Education, Hanoi University of Public Health, Hanoi, Vietnam.'}, {'ForeName': 'Hau', 'Initials': 'H', 'LastName': 'Nguyen', 'Affiliation': ""Global and Women's Health, Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.""}, {'ForeName': 'Ruby', 'Initials': 'R', 'LastName': 'Stocker', 'Affiliation': ""Global and Women's Health, Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.""}, {'ForeName': 'Trang', 'Initials': 'T', 'LastName': 'Nguyen', 'Affiliation': ""Global and Women's Health, Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.""}, {'ForeName': 'Minh', 'Initials': 'M', 'LastName': 'Le', 'Affiliation': ""Global and Women's Health, Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.""}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Fisher', 'Affiliation': ""Global and Women's Health, Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia jane.fisher@monash.edu.""}]",BMJ open,['10.1136/bmjopen-2020-039343']
1650,33068425,Hydroxychloroquine as pre-exposure prophylaxis for COVID-19 in healthcare workers: a randomized trial.,"BACKGROUND


Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a rapidly emerging virus causing the ongoing Covid-19 pandemic with no known effective prophylaxis. We investigated whether hydroxychloroquine could prevent SARS-CoV-2 in healthcare workers at high risk of exposure.
METHODS


We conducted a randomized, double-blind, placebo-controlled clinical trial of healthcare workers with ongoing exposure to persons with SARS-CoV-2, including those working in emergency departments, intensive care units, Covid-19 hospital wards, and first responders. Participants across the United States and in the Canadian province of Manitoba were randomized to hydroxychloroquine 400mg once weekly or twice weekly for 12 weeks. The primary endpoint was confirmed or probable Covid-19-compatible illness. We measured hydroxychloroquine whole blood concentrations.
RESULTS


We enrolled 1483 healthcare workers, of which 79% reported performing aerosol-generating procedures. The incidence of Covid-19 (laboratory-confirmed or symptomatic compatible illness) was 0.27 events per person-year with once-weekly and 0.28 events per person-year with twice-weekly hydroxychloroquine compared with 0.38 events per person-year with placebo. For once weekly hydroxychloroquine prophylaxis, the hazard ratio was 0.72 (95%CI 0.44 to 1.16; P=0.18), and for twice-weekly was 0.74 (95%CI 0.46 to 1.19; P=0.22) as compared with placebo. Median hydroxychloroquine concentrations in whole blood were 98 ng/mL (IQR, 82-120) with once-weekly and 200 ng/mL (IQR, 159-258) with twice-weekly dosing. Hydroxychloroquine concentrations did not differ between participants who developed Covid-19-compatible illness (154 ng/mL) versus participants without Covid-19 (133 ng/mL; P=0.08).
CONCLUSIONS


Pre-exposure prophylaxis with hydroxychloroquine once or twice weekly did not significantly reduce laboratory-confirmed Covid-19 or Covid-19-compatible illness among healthcare workers.",2020,Pre-exposure prophylaxis with hydroxychloroquine once or twice weekly did not significantly reduce laboratory-confirmed Covid-19 or Covid-19-compatible illness among healthcare workers.,"['healthcare workers', 'healthcare workers at high risk of exposure', 'Participants across the United States and in the Canadian province of Manitoba', 'We enrolled 1483 healthcare workers, of which 79% reported performing aerosol-generating procedures', 'healthcare workers with ongoing exposure to persons with SARS-CoV-2, including those working in emergency departments, intensive care units, Covid-19 hospital wards, and first responders']","['placebo', 'hydroxychloroquine', 'Hydroxychloroquine']","['Covid-19-compatible illness', 'probable Covid-19-compatible illness', 'Hydroxychloroquine concentrations', 'Median hydroxychloroquine concentrations', 'incidence of Covid-19 (laboratory-confirmed or symptomatic compatible illness']","[{'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0024726', 'cui_str': 'Manitoba'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0001712', 'cui_str': 'Aerosol'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0557351', 'cui_str': 'Employed'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C3178988', 'cui_str': 'Emergency First Responders'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}]","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0332290', 'cui_str': 'Consistent with'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}]",1483.0,0.743112,Pre-exposure prophylaxis with hydroxychloroquine once or twice weekly did not significantly reduce laboratory-confirmed Covid-19 or Covid-19-compatible illness among healthcare workers.,"[{'ForeName': 'Radha', 'Initials': 'R', 'LastName': 'Rajasingham', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Ananta S', 'Initials': 'AS', 'LastName': 'Bangdiwala', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Melanie R', 'Initials': 'MR', 'LastName': 'Nicol', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Caleb P', 'Initials': 'CP', 'LastName': 'Skipper', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Katelyn A', 'Initials': 'KA', 'LastName': 'Pastick', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Margaret L', 'Initials': 'ML', 'LastName': 'Axelrod', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Matthew F', 'Initials': 'MF', 'LastName': 'Pullen', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Alanna A', 'Initials': 'AA', 'LastName': 'Nascene', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Darlisha A', 'Initials': 'DA', 'LastName': 'Williams', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Nicole W', 'Initials': 'NW', 'LastName': 'Engen', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Okafor', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Brian I', 'Initials': 'BI', 'LastName': 'Rini', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Ingrid A', 'Initials': 'IA', 'LastName': 'Mayer', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Emily G', 'Initials': 'EG', 'LastName': 'McDonald', 'Affiliation': 'Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal.'}, {'ForeName': 'Todd C', 'Initials': 'TC', 'LastName': 'Lee', 'Affiliation': 'Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': 'Oregon Health & Science University, Portland, OR.'}, {'ForeName': 'Lauren J', 'Initials': 'LJ', 'LastName': 'MacKenzie', 'Affiliation': 'Section of Infectious Diseases, Department of Internal Medicine, University of Manitoba, Winnipeg, Manitoba.'}, {'ForeName': 'Justin M', 'Initials': 'JM', 'LastName': 'Balko', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Dunlop', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Katherine H', 'Initials': 'KH', 'LastName': 'Hullsiek', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Boulware', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Sarah M', 'Initials': 'SM', 'LastName': 'Lofgren', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciaa1571']
1651,33068901,"Facilitating Activity and Self-management for people with Arthritic knee, hip or lower back pain (FASA): A cluster randomised controlled trial.","BACKGROUND


Chronic musculoskeletal pain including osteoarthritis (OA) can significantly limit the functional independence of individuals. The spine and hip and knee are predominantly affected; management guidelines for each recommend exercise and education to support self-management.
OBJECTIVES


This study investigated the effectiveness of a generic exercise and self-management intervention for people over-50 with hip/knee OA and/or lower back pain compared to continued GP management.
DESIGN


Single blind, cluster randomised controlled trial.
METHOD


Participants who had previously consulted with hip/knee OA and/or chronic lower back pain were recruited from 45 GP practices in SW England. Practices were randomly allocated to receive continued GP care (control) or continued GP care and a 6-week group exercise and self-management intervention facilitated by a physiotherapist and located in a community-based physiotherapy department. The primary outcome measure was the Dysfunction Index of the Short Musculoskeletal Functional Assessment (DI-SMFA) measured at six month post-rehabilitation.
RESULTS


349 participants were recruited and allocated to the intervention (n = 170) or control (n = 179) arms; the attrition rate was 13% at the 6 month primary end-point. One minor adverse event in the intervention group that required no medical input was reported. Intervention arm participants reported better function at 6 months compared with continued GP management alone (-3.01 difference in DI-SMFA [95%CI -5.25, -0.76], p = 0.01).
CONCLUSIONS


A generic exercise and self-management intervention resulted in statistically significant changes in function after six-months compared with GP management alone, but clinical significance of these findings is less clear. This may be an effective way of managing group interventions for lower limb OA and chronic lower back pain.",2020,"A generic exercise and self-management intervention resulted in statistically significant changes in function after six-months compared with GP management alone, but clinical significance of these findings is less clear.","['people with Arthritic knee, hip or lower back pain (FASA', 'people over-50 with hip/knee OA and/or lower back pain', '349 participants', 'Participants who had previously consulted with hip/knee OA and/or chronic lower back pain were recruited from 45\xa0GP practices in SW England', 'Chronic musculoskeletal pain including osteoarthritis (OA']","['generic exercise and self-management intervention', 'continued GP care (control) or continued GP care and a 6-week group exercise and self-management intervention facilitated by a physiotherapist and located in a community-based physiotherapy department', 'continued GP management alone']","['Dysfunction Index of the Short Musculoskeletal Functional Assessment (DI-SMFA', 'attrition rate']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0746683', 'cui_str': 'Chronic musculoskeletal pain'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}]","[{'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0587975', 'cui_str': 'Physiotherapy department'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}]",349.0,0.105192,"A generic exercise and self-management intervention resulted in statistically significant changes in function after six-months compared with GP management alone, but clinical significance of these findings is less clear.","[{'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Walsh', 'Affiliation': 'Faculty of Health and Applied Sciences, University of the West of England, Bristol, UK. Electronic address: Nicola.walsh@uwe.ac.uk.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Jones', 'Affiliation': 'Faculty of Health and Applied Sciences, University of the West of England, Bristol, UK.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Phillips', 'Affiliation': 'Faculty of Health and Applied Sciences, University of the West of England, Bristol, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Thomas', 'Affiliation': 'Faculty of Health and Applied Sciences, University of the West of England, Bristol, UK.'}, {'ForeName': ""Lang'o"", 'Initials': 'L', 'LastName': 'Odondi', 'Affiliation': 'Division of Cardiovascular Medicine, University of Nottingham, UK.'}, {'ForeName': 'Shea', 'Initials': 'S', 'LastName': 'Palmer', 'Affiliation': 'Faculty of Health and Applied Sciences, University of the West of England, Bristol, UK.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Cramp', 'Affiliation': 'Faculty of Health and Applied Sciences, University of the West of England, Bristol, UK.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Pollock', 'Affiliation': 'Faculty of Health and Applied Sciences, University of the West of England, Bristol, UK.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Hurley', 'Affiliation': ""Faculty for Health, Social Care and Education. St George's University of London & Kingston University, UK.""}]",Musculoskeletal science & practice,['10.1016/j.msksp.2020.102271']
1652,33071501,Efficacy of Prednisolone Mouthwash in Management of Grade III Oral Submucous Fibrosis: A Newer Drug Regimen.,"Introduction


This clinical randomized controlled trial evaluates the effectiveness of prednisolone mouthwash as a treatment modality for moderately advanced cases of oral submucous fibrosis.
Materials and Method


Sixty-four patients were enrolled for the study and randomized into two groups ( n  = 32 in each group). The experimental group was treated with prednisolone mouthwash and antioxidant capsule as per GDCH Nagpur protocol, and control group was treated with antioxidant capsule only. The primary outcome variables were interincisal mouth opening, burning sensation, and recurrent ulceration. Clinical responses were obtained at the time of the allocation, at 1, 3, 6, and 9 months into the intervention, and 6 months thereafter.
Results


The average increased mouth opening achieved was 10.46 mm ( p  < 0.5) in group A (experimental group) and only 1.04 mm ( p  < 0.5) mm in group B (control group). In addition, there was a significant difference in relief of burning sensation and recurrent ulceration. Relief of burning sensation and recurrent ulceration was within 12.81 and 10.93 days, respectively, in group A when compared to group B which was within 21.56 and 20.06 days, respectively.
Conclusion


We conclude that in our trial, prednisolone mouthwash with antioxidants was seen to be efficacious, safe, and reliable in the management of oral submucous fibrosis.",2020,The average increased mouth opening achieved was 10.46 mm ( p  < 0.5) in group A (experimental group) and only 1.04 mm ( p  < 0.5) mm in group B (control group).,"['Materials and Method\n\n\nSixty-four patients were enrolled for the study and randomized into two groups ( n \u2009=\u200932 in each group', 'moderately advanced cases of oral submucous fibrosis', 'Grade III Oral Submucous Fibrosis']","['prednisolone mouthwash and antioxidant capsule as per GDCH Nagpur\xa0protocol, and control group was treated with antioxidant capsule only', 'Prednisolone Mouthwash', 'prednisolone mouthwash with antioxidants', 'prednisolone mouthwash']","['average increased mouth opening', 'interincisal mouth opening, burning sensation, and recurrent ulceration', 'Relief of burning sensation and recurrent ulceration', 'relief of burning sensation and recurrent ulceration']","[{'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0029172', 'cui_str': 'Oral submucosal fibrosis'}, {'cui': 'C0205617', 'cui_str': 'Poorly differentiated'}]","[{'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0026647', 'cui_str': 'Oromucosal solution for gargle'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0240379', 'cui_str': 'Open mouth'}, {'cui': 'C0085624', 'cui_str': 'Burning sensation'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}]",64.0,0.0721379,The average increased mouth opening achieved was 10.46 mm ( p  < 0.5) in group A (experimental group) and only 1.04 mm ( p  < 0.5) mm in group B (control group).,"[{'ForeName': 'Abhay', 'Initials': 'A', 'LastName': 'Datarkar', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Government Dental College & Hospital, Medical Campus, Medical Square, Nagpur, Maharashtra 440003 India.'}, {'ForeName': 'Abhishek', 'Initials': 'A', 'LastName': 'Akare', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Government Dental College & Hospital, Medical Campus, Medical Square, Nagpur, Maharashtra 440003 India.'}, {'ForeName': 'Shikha', 'Initials': 'S', 'LastName': 'Tayal', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Government Dental College & Hospital, Medical Campus, Medical Square, Nagpur, Maharashtra 440003 India.'}]",Journal of maxillofacial and oral surgery,['10.1007/s12663-019-01248-3']
1653,33071503,Comparative Study on the Efficacy of Postsurgical Oral Prophylactic Antibiotic Versus Antimicrobial Suture Placement Alone in Preventing Surgical Site Infection After Removal of Impacted Mandibular Third Molar.,"Aim


To evaluate the efficacy of postsurgical oral prophylactic antibiotic versus antimicrobial suture placement in preventing infection after removal of an impacted mandibular third molar.
Materials and methods


This was a prospective, single-blind study including 150 individuals of 18-40 years divided into two groups with 75 patients each. The patients in Group 1 were administered oral amoxicillin tablets 500 mg for 5 days postsurgery with 3-0 polyglactin sutures for closure and in group 2 with (3-0) antimicrobial chlorhexidine diacetate-impregnated polyglactin sutures only. Evaluation was done on 3rd, 7th, 15th days and 1 month.
Results


There was no significant difference in rates of infection between the groups. Abnormal erythema, pain and trismus showed statistically better results in group 2 on 3rd and 7th days. An antibiotic side effect assessment showed 17.65% patients with minor side effects.
Conclusion


Chlorhexidine diacetate-impregnated polyglactin sutures showed reduced erythema, pain and trismus in healthy patients undergoing surgical removal of third molar.",2020,There was no significant difference in rates of infection between the groups.,"['150 individuals of 18-40\xa0years divided into two groups with 75 patients each', 'healthy patients undergoing surgical removal of third molar']","['oral amoxicillin tablets 500\xa0mg for 5\xa0days postsurgery with 3-0 polyglactin sutures for closure and in group 2 with (3-0) antimicrobial chlorhexidine diacetate-impregnated polyglactin sutures only', 'Postsurgical Oral Prophylactic Antibiotic Versus Antimicrobial Suture Placement Alone', 'postsurgical oral prophylactic antibiotic versus antimicrobial suture placement', 'Chlorhexidine diacetate-impregnated polyglactin sutures']","['rates of infection', 'Abnormal erythema, pain and trismus', 'erythema, pain and trismus', 'Surgical Site Infection']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1244600', 'cui_str': 'Amoxicillin Oral Tablet'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0183740', 'cui_str': 'Polyglactin suture'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0521947', 'cui_str': 'Chlorhexidine diacetate'}, {'cui': 'C0362063', 'cui_str': 'Other prophylactic chemotherapy'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0041105', 'cui_str': 'Trismus'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}]",,0.0820965,There was no significant difference in rates of infection between the groups.,"[{'ForeName': 'Shama', 'Initials': 'S', 'LastName': 'Mohan', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Coorg Institute of Dental Sciences, Virajpet, Karnataka India.'}, {'ForeName': 'B S', 'Initials': 'BS', 'LastName': 'Jayanth', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Coorg Institute of Dental Sciences, Virajpet, Karnataka India.'}, {'ForeName': 'Shruthi', 'Initials': 'S', 'LastName': 'Saralaya', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Coorg Institute of Dental Sciences, Virajpet, Karnataka India.'}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Sunil', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Coorg Institute of Dental Sciences, Virajpet, Karnataka India.'}, {'ForeName': 'A S Mohamed', 'Initials': 'ASM', 'LastName': 'Sageer', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Coorg Institute of Dental Sciences, Virajpet, Karnataka India.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Harikrishnan', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Coorg Institute of Dental Sciences, Virajpet, Karnataka India.'}]",Journal of maxillofacial and oral surgery,['10.1007/s12663-019-01267-0']
1654,33071504,Comparison of Immediate Implant Placement Following Extraction with and Without Socket-Shield Technique in Esthetic Region.,"Introduction


Immediate implant with socket shield and immediate implant without socket shield are the two techniques which can be used to preserve the already thin labial bone in the esthetic region, thus eliminating the need for graft materials.
Aim


To compare the efficacy of immediate implant placement after extraction without socket-shield technique and with socket-shield technique in the esthetic region.
Materials and Methods


Sixteen patients who reported with unsalvageable maxillary anterior teeth with labial bone thickness of less than 2 mm, depicted on preoperative CBCT, were chosen for the study and randomly assigned one of the two groups: Group A comprising socket-shield technique patients and Group B comprising immediate implant placement without socket shield. The labial bone thickness was analyzed along its entire length through CBCT scan at definite follow-up intervals up to a period of 12 months after the procedure.
Results


Follow-up of 1 year demonstrated a statistically significant reduction in the labial bone thickness at the crest in Group B after 8th and 12th months of implant placement.
Conclusion


The two techniques need further comparison though our study results demonstrated better preservation of bone through the socket-shield technique, thus eliminating the need for any bony substitutes.",2020,"Results


Follow-up of 1 year demonstrated a statistically significant reduction in the labial bone thickness at the crest in Group B after 8th and 12th months of implant placement.
","['Sixteen patients who reported with unsalvageable maxillary anterior teeth with labial bone thickness of less than 2\xa0mm, depicted on preoperative CBCT']","['Immediate Implant Placement', 'immediate implant placement after extraction without socket-shield technique and with socket-shield technique', 'socket-shield technique patients and Group B comprising immediate implant placement without socket shield']",['labial bone thickness'],"[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0023759', 'cui_str': 'Lip structure'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0224517', 'cui_str': 'Gomphosis structure'}, {'cui': 'C0183251', 'cui_str': 'Shield'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}]","[{'cui': 'C0023759', 'cui_str': 'Lip structure'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}]",16.0,0.0325692,"Results


Follow-up of 1 year demonstrated a statistically significant reduction in the labial bone thickness at the crest in Group B after 8th and 12th months of implant placement.
","[{'ForeName': 'Shamita', 'Initials': 'S', 'LastName': 'Tiwari', 'Affiliation': 'Department of OMFS, Saraswati Dental College and Hospital, Lucknow, Uttar Pradesh India.'}, {'ForeName': 'Ravinder Singh', 'Initials': 'RS', 'LastName': 'Bedi', 'Affiliation': 'Department of OMFS, Saraswati Dental College and Hospital, Lucknow, Uttar Pradesh India.'}, {'ForeName': 'Puneet', 'Initials': 'P', 'LastName': 'Wadhwani', 'Affiliation': 'Department of OMFS, Saraswati Dental College and Hospital, Lucknow, Uttar Pradesh India.'}, {'ForeName': 'Jitender Kumar', 'Initials': 'JK', 'LastName': 'Aurora', 'Affiliation': 'Department of OMFS, Saraswati Dental College and Hospital, Lucknow, Uttar Pradesh India.'}, {'ForeName': 'Himanshu', 'Initials': 'H', 'LastName': 'Chauhan', 'Affiliation': 'Department of OMFS, Saraswati Dental College and Hospital, Lucknow, Uttar Pradesh India.'}]",Journal of maxillofacial and oral surgery,['10.1007/s12663-019-01272-3']
1655,33071512,A Comparative Study Between Ondansetron and Gabapentin for Prevention of Postoperative Nausea and Vomiting Following Maxillofacial Surgery.,"Background and Aim


Gabapentin is an antiepileptic drug with antiemetic properties. We evaluated prophylactic oral gabapentin as compared with ondansetron for postoperative nausea and vomiting (PONV) in patients undergoing maxillo facial surgery.
Settings and Design


A double-blind, randomized study in a teaching hospital.
Materials and Methods


Seventy patients of ASA physical status I and II, scheduled to undergo maxillofacial surgery, were randomly assigned into two groups to receive 300 mg gabapentin or 8 mg ondansetron 1 h before surgery. Standard anaesthesia technique was used in all patients. Students' t test for difference of means between two groups was used for continuous variables. Chi square or Fisher's exact test was used for comparing proportion between two groups. Kaplan-Meier survival analysis was performed to compare the time to event observed between ondansetron and gabapentin groups. Log-rank test was performed to detect statistical significance of time to events between two groups.
Results


There was no significant difference in incidence of PONV between two groups within 2 h postoperatively. No incidence of PONV was observed in gabapentin group within 2-24 h as compared to ondansetron group in which PONV was observed in five cases.
Conclusion


Gabapentin effectively suppresses PONV in maxillo facial surgery.",2020,"No incidence of PONV was observed in gabapentin group within 2-24 h as compared to ondansetron group in which PONV was observed in five cases.
","['Seventy patients of ASA physical status I and II, scheduled to undergo maxillofacial surgery', 'patients undergoing maxillo facial surgery']","['Gabapentin', 'gabapentin or 8\xa0mg ondansetron', 'Ondansetron and Gabapentin', 'gabapentin', 'ondansetron']","['postoperative nausea and vomiting (PONV', 'incidence of PONV', 'Postoperative Nausea and Vomiting']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0038908', 'cui_str': 'Oral surgery'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0060926', 'cui_str': 'gabapentin'}, {'cui': 'C0061851', 'cui_str': 'Ondansetron'}]","[{'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",,0.123845,"No incidence of PONV was observed in gabapentin group within 2-24 h as compared to ondansetron group in which PONV was observed in five cases.
","[{'ForeName': 'Preksha', 'Initials': 'P', 'LastName': 'Dubey', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, ITS Dental College and Research Centre, Greater Noida, 201308 India.'}, {'ForeName': 'Gopal K', 'Initials': 'GK', 'LastName': 'Thapliyal', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, ITS Dental College and Research Centre, Greater Noida, 201308 India.'}, {'ForeName': 'Alok', 'Initials': 'A', 'LastName': 'Ranjan', 'Affiliation': 'Department of Social and Preventive Medicine, All India Institute of Medical Sciences, Patna, India.'}]",Journal of maxillofacial and oral surgery,['10.1007/s12663-020-01366-3']
1656,33071908,"Mindfulness-Based Stress Reduction Benefits Psychological Well-Being, Sleep Quality, and Athletic Performance in Female Collegiate Rowers.","Factors such as psychological well-being, sleep quality, and athletic coping skills can influence athletic performance. Mindfulness-based interventions, including mindfulness-based stress reduction (MBSR), have been shown to benefit these factors, suggesting they may, at least indirectly, benefit athletic performance. Moreover, while mindfulness training has been linked to better accuracy in some high-precision sports, whether it can improve non-precision elements of athletic performance is unclear. The objective of this study was to investigate the influence of MBSR on psychological well-being, sleep, athletic coping skills, and rowing performance in collegiate rowers in a controlled experimental design. Members of a Division I NCAA Women's Rowing team completed either an 8-week MBSR course along with their regular athletic training program (Intervention group) or the athletic training program alone (Control group). Measurements of interest were taken at baseline and again either during or shortly following the intervention. In contrast to the Control group, the Intervention group showed improvements in psychological well-being, subjective and objective sleep quality, athletic coping skills, and rowing performance as measured by a 6,000-m ergometer test. Improvements in athletic coping skills, psychological well-being, and subjective sleep quality were all correlated with increases in mindfulness in the Intervention group. These results suggest that mindfulness training may benefit non-precision aspects of athletic performance. Incorporating mindfulness training into athletic training programs may benefit quality of life and performance in student athletes.",2020,"In contrast to the Control group, the Intervention group showed improvements in psychological well-being, subjective and objective sleep quality, athletic coping skills, and rowing performance as measured by a 6,000-m ergometer test.","['Female Collegiate Rowers', 'Members of a Division', 'collegiate rowers', 'student athletes']","['mindfulness training', 'MBSR', 'NCAA', 'regular athletic training program (Intervention group) or the athletic training program alone (Control group', 'Mindfulness-based interventions, including mindfulness-based stress reduction (MBSR']","['Psychological Well-Being, Sleep Quality, and Athletic Performance', 'athletic coping skills, psychological well-being, and subjective sleep quality', 'psychological well-being, subjective and objective sleep quality, athletic coping skills, and rowing performance as measured by a 6,000-m ergometer test', 'psychological well-being, sleep, athletic coping skills, and rowing performance', 'Mindfulness-Based Stress Reduction Benefits']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C1293097', 'cui_str': 'Division'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C1510656', 'cui_str': 'Athletics'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0424578', 'cui_str': 'Well in self'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0871966', 'cui_str': 'Sports Performance'}, {'cui': 'C1510656', 'cui_str': 'Athletics'}, {'cui': 'C0086059', 'cui_str': 'Coping Skills'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C4505111', 'cui_str': 'Rowing'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",,0.0126605,"In contrast to the Control group, the Intervention group showed improvements in psychological well-being, subjective and objective sleep quality, athletic coping skills, and rowing performance as measured by a 6,000-m ergometer test.","[{'ForeName': 'Bethany J', 'Initials': 'BJ', 'LastName': 'Jones', 'Affiliation': 'Department of Psychological and Brain Sciences, University of Massachusetts, Amherst, MA, United States.'}, {'ForeName': 'Sukhmanjit', 'Initials': 'S', 'LastName': 'Kaur', 'Affiliation': 'Department of Psychological and Brain Sciences, University of Massachusetts, Amherst, MA, United States.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Miller', 'Affiliation': 'Amherst Mindfulness, Amherst, MA, United States.'}, {'ForeName': 'Rebecca M C', 'Initials': 'RMC', 'LastName': 'Spencer', 'Affiliation': 'Department of Psychological and Brain Sciences, University of Massachusetts, Amherst, MA, United States.'}]",Frontiers in psychology,['10.3389/fpsyg.2020.572980']
1657,33071935,Neurothrombectomy for Acute Ischemic Stroke Across Clinical Trial Design and Technique: A Single Center Pooled Analysis.,"Introduction:  The practice of endovascular therapy has evolved dramatically over the last 10 years with randomized clinical trials investigating the benefit of thrombectomy in select patient populations based on time of presentation, imaging criteria, and procedural technique. We sought to understand the benefit of thrombectomy in patients treated within the context of a clinical trial at a single academic center.  Methods:  Patient-level data recorded in case forms and core-lab adjudicated data were analyzed from patients enrolled in RCTs investigating the benefit of endovascular thrombectomy over medical management (IMSIII, MR RESCUE, ESCAPE, SWIFT PRIME, and DAWN) between 2007 and 2017 at a single academic referral center.  Results:  A total of 134 patients (intervention group,  n  = 81; medical group,  n  = 53) were identified across five clinical trials (IMSIII,  n  = 46; MR RESCUE,  n  = 4; ESCAPE,  n  = 24; SWIFT PRIME,  n  = 14; DAWN,  n  = 46). There were no significant differences between the treatment arm and control arm in terms of age, gender, baseline NIHSS, ASPECTS, and site of occlusion. Rates of good outcome were superior in the intervention group with early neurological recovery (NIHSS of 0-1 or increase NIHSS of 8 points at 24 h) at a higher rate of 49% vs. 17% ( p  = <0.001) and higher rates of functional independence (90 day mRS 0-2 of 53% vs. 26%,  p  = 0.002). In multivariate logistic regression analysis, lower NIHSS and younger age were predictors of good outcome. There were comparable rates of good outcome irrespective of clinical trial, imaging selection criteria (CTP vs. MRI), early vs. late time window (0-6 h vs. 6-24 h) and procedural technique (Merci vs. Solitaire/Trevo device). There were no differences in rates of sICH, PH-2 or mortality in the intervention group vs. medical group.  Conclusions:  At a large academic center, the benefit of endovascular therapy over medical therapy is observed irrespective of clinical trial design, patient selection or procedural technique.",2020,"There were no significant differences between the treatment arm and control arm in terms of age, gender, baseline NIHSS, ASPECTS, and site of occlusion.","['Methods:  Patient-level data recorded in case forms and core-lab adjudicated data were analyzed from patients enrolled in RCTs investigating the benefit of endovascular thrombectomy over medical management (IMSIII, MR RESCUE, ESCAPE, SWIFT PRIME, and DAWN) between 2007 and 2017 at a single academic referral center', 'patients treated within the context of a clinical trial at a single academic center', '134 patients (intervention group,  n  = 81; medical group,  n  = 53']",['Neurothrombectomy'],"['rates of functional independence', 'rates of sICH, PH-2 or mortality', 'early neurological recovery (NIHSS of 0-1 or increase NIHSS']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1292732', 'cui_str': 'Investigates'}, {'cui': 'C0162578', 'cui_str': 'Removal of thrombus'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0001198', 'cui_str': 'Acrodynia due to mercury'}, {'cui': 'C0071973', 'cui_str': 'PRIME protocol'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0449255', 'cui_str': 'Context'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]",[],"[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C1697238', 'cui_str': 'NIH stroke scale'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",134.0,0.110862,"There were no significant differences between the treatment arm and control arm in terms of age, gender, baseline NIHSS, ASPECTS, and site of occlusion.","[{'ForeName': 'Tudor G', 'Initials': 'TG', 'LastName': 'Jovin', 'Affiliation': 'Department of Neurology, University of Pittsburgh Medical Center, Pittsburgh, PA, United States.'}, {'ForeName': 'Shashvat M', 'Initials': 'SM', 'LastName': 'Desai', 'Affiliation': 'Department of Neurology, University of Pittsburgh Medical Center, Pittsburgh, PA, United States.'}, {'ForeName': 'Amin', 'Initials': 'A', 'LastName': 'Aghaebrahim', 'Affiliation': 'Department of Neurology, University of Pittsburgh Medical Center, Pittsburgh, PA, United States.'}, {'ForeName': 'Andrew F', 'Initials': 'AF', 'LastName': 'Ducruet', 'Affiliation': 'Department of Neurology, University of Pittsburgh Medical Center, Pittsburgh, PA, United States.'}, {'ForeName': 'Dan-Victor', 'Initials': 'DV', 'LastName': 'Giurgiutiu', 'Affiliation': 'Department of Neurology, University of Pittsburgh Medical Center, Pittsburgh, PA, United States.'}, {'ForeName': 'Bradley A', 'Initials': 'BA', 'LastName': 'Gross', 'Affiliation': 'Department of Neurology, University of Pittsburgh Medical Center, Pittsburgh, PA, United States.'}, {'ForeName': 'Maxim', 'Initials': 'M', 'LastName': 'Hammer', 'Affiliation': 'Department of Neurology, University of Pittsburgh Medical Center, Pittsburgh, PA, United States.'}, {'ForeName': 'Brian T', 'Initials': 'BT', 'LastName': 'Jankowitz', 'Affiliation': 'Department of Neurology, University of Pittsburgh Medical Center, Pittsburgh, PA, United States.'}, {'ForeName': 'Mouhammad A', 'Initials': 'MA', 'LastName': 'Jumaa', 'Affiliation': 'Department of Neurology, University of Pittsburgh Medical Center, Pittsburgh, PA, United States.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Kenmuir', 'Affiliation': 'Department of Neurology, University of Pittsburgh Medical Center, Pittsburgh, PA, United States.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Linares', 'Affiliation': 'Department of Neurology, University of Pittsburgh Medical Center, Pittsburgh, PA, United States.'}, {'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Reddy', 'Affiliation': 'Department of Neurology, University of Pittsburgh Medical Center, Pittsburgh, PA, United States.'}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Rocha', 'Affiliation': 'Department of Neurology, University of Pittsburgh Medical Center, Pittsburgh, PA, United States.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Starr', 'Affiliation': 'Department of Neurology, University of Pittsburgh Medical Center, Pittsburgh, PA, United States.'}, {'ForeName': 'Viktoria', 'Initials': 'V', 'LastName': 'Totoraitis', 'Affiliation': 'Department of Neurology, University of Pittsburgh Medical Center, Pittsburgh, PA, United States.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Wechsler', 'Affiliation': 'Department of Neurology, University of Pittsburgh Medical Center, Pittsburgh, PA, United States.'}, {'ForeName': 'Syed', 'Initials': 'S', 'LastName': 'Zaidi', 'Affiliation': 'Department of Neurology, University of Pittsburgh Medical Center, Pittsburgh, PA, United States.'}, {'ForeName': 'Ashutosh P', 'Initials': 'AP', 'LastName': 'Jadhav', 'Affiliation': 'Department of Neurology, University of Pittsburgh Medical Center, Pittsburgh, PA, United States.'}]",Frontiers in neurology,['10.3389/fneur.2020.01047']
1658,33071982,Independent and Distinct Associations of FABP4 and FABP5 With Metabolic Parameters in Type 2 Diabetes Mellitus.,"Objective:  Among fatty acid-binding proteins (FABPs), secreted forms of FABP4 and FABP5, which are expressed in adipocytes and macrophages, act as bioactive molecules. We investigated concentrations of FABP4 and FABP5 in patients with type 2 diabetes mellitus.  Methods:  As a sub-analysis study of the Randomized Evaluation of Anagliptin vs. Sitagliptin On low-density lipoproteiN cholesterol in diabetes (REASON) trial, 256 patients (male/female: 146/110, age: 68 ± 10 years) with type 2 diabetes mellitus and dyslipidemia who were receiving statin therapy were recruited. Patients who had been treated with a thiazolidinedione were excluded.  Results:  Several drugs which may modulate FABP4 levels including statins, dipeptidyl peptidase-4 inhibitors and angiotensin II receptor blockers had been administered in 100, 81, and 51% of the recruited patients, respectively. The level of FABP4, but not that of FABP5, was significantly higher in females than in males. Multivariable linear regression analysis demonstrated that waist circumference (β = 0.21), estimated glomerular filtration rate (β = -0.31), triglycerides (β = 0.16), and FABP5 (β = 0.39) were independent predictors of FABP4 level after adjusting age and sex. On the other hand, FABP5 level was independently associated with levels of FABP4 (β = 0.57) and high-density lipoprotein (HDL) cholesterol (β = -0.12).  Conclusions:  Concentrations of FABP4 and FABP5 are independent predictors of each other in patients with type 2 diabetes mellitus. There are distinct independent associations of FABP4 with renal dysfunction, adiposity and hypertriglyceridemia and there is a distinct independent association of FABP5 with a low HDL cholesterol level in type 2 diabetic patients with dyslipidemia at high risks for cardiovascular disease who are receiving statin therapy.",2020,"The level of FABP4, but not that of FABP5, was significantly higher in females than in males.","['patients with type 2 diabetes mellitus', 'Type 2 Diabetes Mellitus', 'Patients who had been treated with a thiazolidinedione were excluded', '256 patients (male/female: 146/110, age: 68 ± 10 years) with type 2 diabetes mellitus and dyslipidemia who were receiving statin therapy were recruited', 'diabetic patients with dyslipidemia at high risks for cardiovascular disease who are receiving statin therapy']","['Anagliptin vs. Sitagliptin', 'FABP5', 'FABP4 and FABP5', 'fatty acid-binding proteins (FABPs']","['level of FABP4', 'glomerular filtration rate', 'levels of FABP4 (β = 0.57) and high-density lipoprotein (HDL) cholesterol', 'FABP4 level']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0289779', 'cui_str': '2,4-thiazolidinedione'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}]","[{'cui': 'C3272640', 'cui_str': 'anagliptin'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C1312695', 'cui_str': 'FABP5 protein, human'}, {'cui': 'C1312689', 'cui_str': 'FABP4 protein, human'}, {'cui': 'C0060095', 'cui_str': 'Fatty Acid-Binding Proteins'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1312689', 'cui_str': 'FABP4 protein, human'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}]",256.0,0.0574567,"The level of FABP4, but not that of FABP5, was significantly higher in females than in males.","[{'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Furuhashi', 'Affiliation': 'Department of Cardiovascular, Renal and Metabolic Medicine, Sapporo Medical University School of Medicine, Sapporo, Japan.'}, {'ForeName': 'Ichiro', 'Initials': 'I', 'LastName': 'Sakuma', 'Affiliation': 'Caress Sapporo Hokko Memorial Clinic, Sapporo, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Morimoto', 'Affiliation': 'Department of Clinical Epidemiology, Hyogo College of Medicine, Nishinomiya, Japan.'}, {'ForeName': 'Yukimura', 'Initials': 'Y', 'LastName': 'Higashiura', 'Affiliation': 'Department of Cardiovascular, Renal and Metabolic Medicine, Sapporo Medical University School of Medicine, Sapporo, Japan.'}, {'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Sakai', 'Affiliation': 'Department of Cardiovascular, Renal and Metabolic Medicine, Sapporo Medical University School of Medicine, Sapporo, Japan.'}, {'ForeName': 'Megumi', 'Initials': 'M', 'LastName': 'Matsumoto', 'Affiliation': 'Department of Cardiovascular, Renal and Metabolic Medicine, Sapporo Medical University School of Medicine, Sapporo, Japan.'}, {'ForeName': 'Mio', 'Initials': 'M', 'LastName': 'Sakuma', 'Affiliation': 'Department of Clinical Epidemiology, Hyogo College of Medicine, Nishinomiya, Japan.'}, {'ForeName': 'Michio', 'Initials': 'M', 'LastName': 'Shimabukuro', 'Affiliation': 'Department of Diabetes, Endocrinology and Metabolism, Fukushima Medical University, Fukushima, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Nomiyama', 'Affiliation': 'Department of Diabetes, Metabolism and Endocrinology, International University of Health and Welfare Ichikawa Hospital, Ichikawa, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Arasaki', 'Affiliation': 'Department of Cardiology, Tomishiro Central Hospital, Tomigusuku, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Node', 'Affiliation': 'Department of Cardiovascular Medicine, Saga University, Saga, Japan.'}, {'ForeName': 'Shinichiro', 'Initials': 'S', 'LastName': 'Ueda', 'Affiliation': 'Department of Pharmacology and Therapeutics, University of the Ryukyus, Okinawa, Japan.'}]",Frontiers in endocrinology,['10.3389/fendo.2020.575557']
1659,33071986,"Effects of a Chinese Patent Medicine Gushen'antai Pills on Ongoing Pregnancy Rate of Hormone Therapy FET Cycles: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Clinical Trial.","In the past decade, the number of frozen-thawed embryo transfer (FET) has increased dramatically with the expansion of surgical indications and the improvement of freezing related technologies. How to improve the success rate and reduce the adverse effects of FET is our research priorities. This study aimed to investigate the safety and effectiveness of Gushen'antai pills (GSATP) by measuring the ongoing pregnancy rate (OPR) in patients from FET and hormone therapy (HT) cycle. From November 2019 to May 2020, 5 Chinese hospitals conducted a multi-center, randomized, double-blind, placebo-controlled study. In total, 271 HT FET cycles in patients were randomly divided (1:1 ratio) to receive GSATP (6 g, tid) or placebo (6g, tid) for 12 weeks of pregnancy. Patients, clinicians, and researchers were blinded to treatment allocation. The primary endpoint was the OPR at week 12 of pregnancy. The secondary endpoints were vaginal bleeding or brown discharge rate, implantation rate (IR), clinical pregnancy rate (CPR) and abortion rate (AR). Adverse events were recorded during the treatment period. The results showed that the OPR remained higher in the GSATP group when compared to placebo group (56.62% vs. 44.44%,  p  = 0.045). Vaginal bleeding or brown discharge rate was lower in the GSATP group than the placebo group (10% vs. 23.08%,  p  = 0.032), while the IR (35.16% vs. 27.64%,  p  = 0.070), CPR (58.82% vs. 48.15%,  p  = 0.078), incidence of total adverse events (8.09% vs. 3.22%,  p  = 0.051) and AR (3.75% vs. 7.69%,  p  = 0.504) were similar between GSATP and placebo groups. Subgroup analysis showed that there were significant differences in CPR (74.19% vs. 54.17%,  p  = 0.004) and OPR (72.04% vs. 51.04%,  p  = 0.003) between GSATP group and Placebo group when the patient was younger than 35 years old. This multi-center, randomized, double-blinded, placebo-controlled clinical study showed for the first evidence that GSATP may have potential to improve the OPR and decrease vaginal bleeding or brown discharge rate in HT FET cycle patients.",2020,"Vaginal bleeding or brown discharge rate was lower in the GSATP group than the placebo group (10% vs. 23.08%,  p  = 0.032), while the IR (35.16% vs. 27.64%,  p  = 0.070), CPR (58.82% vs. 48.15%,  p  = 0.078), incidence of total adverse events (8.09% vs. 3.22%,  p  = 0.051) and AR (3.75% vs. 7.69%,  p  = 0.504) were similar between GSATP and placebo groups.","['From November 2019 to May 2020, 5 Chinese hospitals conducted a multi-center', 'patients from FET and hormone therapy (HT) cycle', 'Hormone Therapy FET Cycles']","['FET', 'GSATP', ""Gushen'antai pills (GSATP"", 'placebo', ""Chinese Patent Medicine Gushen'antai Pills"", 'Placebo']","['incidence of total adverse events', 'ongoing pregnancy rate (OPR', 'OPR', 'Adverse events', 'AR', 'Vaginal bleeding or brown discharge rate', 'vaginal bleeding or brown discharge rate, implantation rate (IR), clinical pregnancy rate (CPR) and abortion rate (AR', 'CPR']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0016701', 'cui_str': 'Freezing'}, {'cui': 'C0013938', 'cui_str': 'Embryo transfer'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}]","[{'cui': 'C0016701', 'cui_str': 'Freezing'}, {'cui': 'C0013938', 'cui_str': 'Embryo transfer'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0013231', 'cui_str': 'Drugs, Non-Prescription'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0000794', 'cui_str': 'Abortion Rate'}, {'cui': 'C2979982', 'cui_str': 'Vaginal bleeding'}, {'cui': 'C0155339', 'cui_str': ""Brown's tendon sheath syndrome""}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]",,0.582995,"Vaginal bleeding or brown discharge rate was lower in the GSATP group than the placebo group (10% vs. 23.08%,  p  = 0.032), while the IR (35.16% vs. 27.64%,  p  = 0.070), CPR (58.82% vs. 48.15%,  p  = 0.078), incidence of total adverse events (8.09% vs. 3.22%,  p  = 0.051) and AR (3.75% vs. 7.69%,  p  = 0.504) were similar between GSATP and placebo groups.","[{'ForeName': 'Xian-Ling', 'Initials': 'XL', 'LastName': 'Cao', 'Affiliation': 'College of Traditional Chinese Medicine, Shandong University of Traditional Chinese Medicine, Jinan, China.'}, {'ForeName': 'Jing-Yan', 'Initials': 'JY', 'LastName': 'Song', 'Affiliation': 'College of Traditional Chinese Medicine, Shandong University of Traditional Chinese Medicine, Jinan, China.'}, {'ForeName': 'Xing-Xing', 'Initials': 'XX', 'LastName': 'Zhang', 'Affiliation': 'Reproductive Medicine Center, Maternity and Child Health Care of ZaoZhuang, ZaoZhuang, China.'}, {'ForeName': 'Yan-Hua', 'Initials': 'YH', 'LastName': 'Chen', 'Affiliation': 'Shanxi Maternal and Child Health Care Hospital, Taiyuan, China.'}, {'ForeName': 'Yi-Li', 'Initials': 'YL', 'LastName': 'Teng', 'Affiliation': 'The First Affiliated Hospital of Wenzhou Medical University, WenZhou, China.'}, {'ForeName': 'Hai-Ping', 'Initials': 'HP', 'LastName': 'Liu', 'Affiliation': 'The 960th Hospital of the PLA Joint Logistics Support Force, Jinan, China.'}, {'ForeName': 'Tai-You', 'Initials': 'TY', 'LastName': 'Deng', 'Affiliation': 'College of Pharmacy, China Pharmaceutical University, Nanjing, China.'}, {'ForeName': 'Zhen-Gao', 'Initials': 'ZG', 'LastName': 'Sun', 'Affiliation': 'College of Traditional Chinese Medicine, Shandong University of Traditional Chinese Medicine, Jinan, China.'}]",Frontiers in endocrinology,['10.3389/fendo.2020.581719']
1660,33084903,"Use of smokeless tobacco before conception and its relationship with maternal and fetal outcomes of pregnancy in Thatta, Pakistan: Findings from Women First study.","INTRODUCTION


Smokeless tobacco (SLT) consumption during pregnancy has adverse consequences for the mother and fetus. We aimed to investigate the effects of maternal pre-pregnancy SLT consumption on maternal and fetal outcomes in the district of Thatta, Pakistan.
METHODS


We conducted a secondary data analysis of an individual randomized controlled trial of preconception maternal nutrition. Study participants were women of reproductive age residing in the district of Thatta, Pakistan. Participants were asked questions regarding the usage of commonly consumed SLT known as gutka (exposure variable). Study outcomes included maternal anemia, miscarriage, preterm births, stillbirths, and low birth weight. We performed a cox-regression analysis by controlling for confounders such as maternal age, education, parity, working status, body mass index, and geographic clusters.
RESULTS


The study revealed that 71.5% of the women reported using gutka, with a higher proportion residing in rural areas as compared to urban areas in the district of Thatta, Pakistan. In the multivariable analysis, we did not find a statistically significant association between gutka usage and anemia [(RR: 1.04, 95% CI (0.92-1.16)]; miscarriage [(RR: 1.08, 95% CI (0.75-1.54)]; preterm birth [(RR: 1.37, 95% CI (0.64-2.93)]; stillbirth [(RR: 1.02, 95% CI (0.39-2.61)] and low birth weight [(RR: 0.96, 95% CI (0.72-1.28)].
CONCLUSION


The study did not find an association between gutka usage before pregnancy and adverse maternal and fetal outcomes. In the future, robust epidemiological studies are required to detect true differences with a dose-response relationship between gutka usage both before and during pregnancy and adverse feto-maternal outcomes.
IMPLICATIONS


While most epidemiological studies conducted in Pakistan have focused on smoking and its adverse outcomes among males, none of the studies have measured the burden of SLT among women of reproductive age (WRA) and its associated adverse outcomes. In addition, previously conducted studies have primarily assessed the effect of SLT usage during pregnancy rather than before pregnancy on adverse fetal and maternal outcomes. The current study is unique because it provides an insight into the usage of SLT among WRA before pregnancy and investigated the association between pre-pregnancy SLT usage and its adverse feto-maternal outcomes in rural Pakistan.",2020,"In the multivariable analysis, we did not find a statistically significant association between gutka usage and anemia [(RR: 1.04, 95% CI (0.92-1.16)]; miscarriage [(RR: 1.08, 95% CI (0.75-1.54)]; preterm birth [(RR: 1.37, 95% CI (0.64-2.93)]; stillbirth [(RR: 1.02, 95% CI (0.39-2.61)] and low birth weight [(RR: 0.96, 95% CI (0.72-1.28)].
","['Study participants were women of reproductive age residing in the district of Thatta, Pakistan', 'district of Thatta, Pakistan']","['maternal pre-pregnancy SLT consumption', 'preconception maternal nutrition', 'Smokeless tobacco (SLT) consumption']","['maternal anemia, miscarriage, preterm births, stillbirths, and low birth weight', 'gutka usage and anemia', 'stillbirth', 'preterm birth', 'low birth weight']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0040338', 'cui_str': 'Smokeless Tobacco'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1720845', 'cui_str': 'Maternal Nutritional Physiological Phenomenon'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0595939', 'cui_str': 'Stillbirth'}, {'cui': 'C0024032', 'cui_str': 'Low Birth Weights'}, {'cui': 'C4289021', 'cui_str': 'Gutka Tobacco'}, {'cui': 'C0457083', 'cui_str': 'Usage'}]",,0.163725,"In the multivariable analysis, we did not find a statistically significant association between gutka usage and anemia [(RR: 1.04, 95% CI (0.92-1.16)]; miscarriage [(RR: 1.08, 95% CI (0.75-1.54)]; preterm birth [(RR: 1.37, 95% CI (0.64-2.93)]; stillbirth [(RR: 1.02, 95% CI (0.39-2.61)] and low birth weight [(RR: 0.96, 95% CI (0.72-1.28)].
","[{'ForeName': 'Sumera', 'Initials': 'S', 'LastName': 'Aziz Ali', 'Affiliation': 'Department of Epidemiology, Columbia University New York, NY, USA.'}, {'ForeName': 'Umber', 'Initials': 'U', 'LastName': 'Khan', 'Affiliation': 'Department of Community Health Sciences, Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Farina', 'Initials': 'F', 'LastName': 'Abrejo', 'Affiliation': 'Department of Community Health Sciences, Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Brandi', 'Initials': 'B', 'LastName': 'Vollmer', 'Affiliation': 'Department of Epidemiology, Columbia University New York, NY, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Saleem', 'Affiliation': 'Department of Community Health Sciences, Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Hambidge', 'Affiliation': 'Department of Pediatrics, Section of Nutrition, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Nancy F', 'Initials': 'NF', 'LastName': 'Krebs', 'Affiliation': 'Department of Pediatrics, Section of Nutrition, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Jamie E', 'Initials': 'JE', 'LastName': 'Westcott', 'Affiliation': 'Department of Pediatrics, Section of Nutrition, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Goldenberg', 'Affiliation': 'Department of Obstetrics and Gynecology, Columbia University, New York, NY, USA.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'McClure', 'Affiliation': 'RTI International, 3040 E. Cornwallis Road, Research Triangle Park, NC, USA.'}, {'ForeName': 'Omrana', 'Initials': 'O', 'LastName': 'Pasha', 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health, Baltimore, USA.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntaa215']
1661,33084980,"Bovine surfactant in the treatment of pneumonia-induced-neonatal acute respiratory distress syndrome (NARDS) in neonates beyond 34 weeks of gestation: a multicentre, randomized, assessor-blinded, placebo-controlled trial.","Neonatal acute respiratory distress syndrome (NARDS) reflects pulmonary surfactant dysfunction, and the usage of bovine surfactant (Calsurf) supplement may therefore be beneficial. To determine whether bovine surfactant given in NARDS can improve oxygenation and survival rate, we conducted a multicenter, randomized trial between January 2018 and June 2019, and we compared Calsurf treatment to controls in neonates with pneumonia accompanied by NARDS. Neonates who met the Montreux criteria definition of NARDS were included, and those with congenital heart and lung malformations were excluded. Primary outcomes were oxygenation index (OI) after Calsurf administration, and secondary outcomes were mortality, and duration of ventilator and oxygen between the two groups, and also other morbidities. Cumulatively, 328 neonates were recruited and analyzed, 162 in the control group, and 166 in the Calsurf group. The results shows that OI in the Calsurf group were significantly lower than that in the control group at 4 h (7.2 ± 2.7 and 11.4 ± 9.1, P = 0.001); similarly, OI in the Calsurf group were significantly lower than in the control group at 12 h ( 7.5 ± 3.1 and 11.2 ± 9.2, P = 0.001). Mortality and duration of ventilator support or oxygen use between the two groups were not significantly different.Conclusion: Calsurf acutely improved OI immediately after administration in pneumonia-induced NARDS; although, we observed no significant decrease in mortality, duration of ventilator or oxygen, or major morbidity. What is known: • The definition proposed as the Monteux criteria for neonatal acute respiratory distress syndrome (NARDS). • Surfactant acutely improved oxygenation and significantly decreased mortality in children and adolescents with acute lung injury. What is new: • This is the first large randomized controlled trail to study on surfactant treatment of neonates with acute respiratory distress syndromes. • Surfactant acutely improved oxygenation immediately after administration in pneumonia-induced NARDS at a gestational age beyond 34 weeks.",2020,Mortality and duration of ventilator support or oxygen use between the two groups were not significantly different.,"['Neonates who met the Montreux criteria definition of NARDS were included, and those with congenital heart and lung malformations', 'neonates with acute respiratory distress syndromes', 'pneumonia-induced-neonatal acute respiratory distress syndrome (NARDS) in neonates beyond 34 weeks of gestation', 'Neonatal acute respiratory distress syndrome (NARDS', 'neonatal acute respiratory distress syndrome (NARDS', 'neonates with pneumonia accompanied by NARDS', '328 neonates were recruited and analyzed, 162 in the control group, and 166 in the Calsurf group', 'children and adolescents with acute lung injury']","['bovine surfactant (Calsurf) supplement', 'placebo', 'Bovine surfactant', 'bovine surfactant given in NARDS']","['Mortality and duration of ventilator support or oxygen use', 'oxygenation and survival rate', 'mortality, duration of ventilator or oxygen, or major morbidity', 'oxygenation index (OI) after Calsurf administration, and secondary outcomes were mortality, and duration of ventilator and oxygen', 'mortality']","[{'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009678', 'cui_str': 'congenital'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C5191360', 'cui_str': '162'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C5191361', 'cui_str': '166'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0242488', 'cui_str': 'Acute lung injury'}]","[{'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'C0034085', 'cui_str': 'Lung surfactant'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C1278185', 'cui_str': 'Oxygenation index measurement'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",328.0,0.0738327,Mortality and duration of ventilator support or oxygen use between the two groups were not significantly different.,"[{'ForeName': 'Zhihui', 'Initials': 'Z', 'LastName': 'Rong', 'Affiliation': 'Department of Neonatology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China.'}, {'ForeName': 'Luxia', 'Initials': 'L', 'LastName': 'Mo', 'Affiliation': 'Department of Neonatology, Wuhan Maternal and Child Healthcare Hospital, Tongji Medical College, Huazhong University of Science & Technology, Wuhan, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Pan', 'Affiliation': 'Department of Neonatology, Xiangyang Central Hospital, Affiliated Hospital of Hubei University of Arts and Science, Xiangyang, China.'}, {'ForeName': 'Xiaofang', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Department of Neonatology, Jingzhou Central Hospital, Jingzhou, China.'}, {'ForeName': 'Hongbin', 'Initials': 'H', 'LastName': 'Cheng', 'Affiliation': 'Department of Neonatology, HuangShi Maternal and Child Healthcare Hospital, Huangshi, China.'}, {'ForeName': 'Maojun', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': ""Department of Neonatology, Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospital, Sichuan, China.""}, {'ForeName': 'Lubiao', 'Initials': 'L', 'LastName': 'Yan', 'Affiliation': 'Department of Neonatology, Maternal and Child Healthcare Hospital, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Yujie', 'Initials': 'Y', 'LastName': 'Lang', 'Affiliation': ""Department of Neonatology, Children's Hospital of Jinan, Jinan, China.""}, {'ForeName': 'Xiaoshan', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': ""Department of Neonatology, Anhui Provincial Children's Hospital, Hefei, China.""}, {'ForeName': 'Liping', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': ""Department of Neonatology, Jiangxi Provincial Children's Hospital, Jiangxi, China.""}, {'ForeName': 'Shiwen', 'Initials': 'S', 'LastName': 'Xia', 'Affiliation': 'Department of Neonatology, Hubei Maternity and Child Heath Hospital, Wuhan, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Han', 'Affiliation': 'Department of Neonatology, The First Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Liwen', 'Initials': 'L', 'LastName': 'Chang', 'Affiliation': 'Department of Neonatology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China. 13871530925@163.com.'}]",European journal of pediatrics,['10.1007/s00431-020-03821-2']
1662,33085021,Risk factors for early reherniation after lumbar discectomy with or without annular closure: results of a multicenter randomized controlled study.,"BACKGROUND


Reherniation after lumbar discectomy is classified as a failure and occurs in 3 to 18% of cases. Various risk factors for reherniation such as age, sex, body mass index, smoking, and size of annular defect have been reported. The aim of this study was to identify risk factors for early reherniation after one-level lumbar discectomy with or without annular closure within 3 months after surgery.
METHODS


This study is based on data analysis of a prospective, multicenter randomized controlled trial in Europe. Patients included underwent standard lumbar discectomy-with or without implantation of an annular closure device (ACD). Enrollment of 554 patients in 21 centers in Europe (Germany, Switzerland, Austria, Belgium, The Netherlands, and France) started in 2010 and was completed in October 2014. A total of 276 patients were randomized to the ACD group (ACG) and 278 patients to the control group (CG).
RESULTS


Four (1.5%) symptomatic reherniations occurred in the ACG and 18 (6.5%) in the CG. In the overall population, a significant correlation was found with recurrent herniation for disc degeneration (Pfirrmann p = 0.009) and a trend for current smoker status (p = 0.07). In CG, age ≥ 50 years (p = 0.05) and disc degeneration (Pfirrmann p = 0.026, Kellgren and Lawrence p = 0.013) were predictive factors for reherniation.
CONCLUSION


In the current study, risk factors for early recurrent disc herniation after lumbar discectomy were age ≥ 50 years and moderate disc degeneration. The annular closure device reduced the risk of early reherniation.
TRIAL REGISTRATION


Clinicaltrials.gov NCT01283438.",2020,"50 years (p = 0.05) and disc degeneration (Pfirrmann p = 0.026, Kellgren and Lawrence p = 0.013) were predictive factors for reherniation.
","['early recurrent disc herniation after lumbar discectomy were age ≥', '50\xa0years and moderate disc degeneration', '276 patients', '554 patients in 21 centers in Europe (Germany, Switzerland, Austria, Belgium, The Netherlands, and France) started in 2010 and was completed in October 2014']","['lumbar discectomy with or without annular closure', 'ACD group (ACG', 'standard lumbar discectomy-with or without implantation of an annular closure device (ACD', 'control group (CG']","['current smoker status', 'risk of early reherniation', 'recurrent herniation for disc degeneration', 'disc degeneration', 'symptomatic reherniations']","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0408632', 'cui_str': 'Excision of lumbar intervertebral disc'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0158266', 'cui_str': 'Degeneration of intervertebral disc'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0004348', 'cui_str': 'Austria'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0408632', 'cui_str': 'Excision of lumbar intervertebral disc'}, {'cui': 'C0521164', 'cui_str': 'Annular shape'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002873', 'cui_str': 'Anemia of chronic disease'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0158266', 'cui_str': 'Degeneration of intervertebral disc'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}]",276.0,0.093442,"50 years (p = 0.05) and disc degeneration (Pfirrmann p = 0.026, Kellgren and Lawrence p = 0.013) were predictive factors for reherniation.
","[{'ForeName': 'Jenny C', 'Initials': 'JC', 'LastName': 'Kienzler', 'Affiliation': 'Department of Neurosurgery, Kantonsspital Aarau, Tellstrasse, 5001, Aarau, Switzerland.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Fandino', 'Affiliation': 'Department of Neurosurgery, Kantonsspital Aarau, Tellstrasse, 5001, Aarau, Switzerland. fandino@neurochirurgie-ag.ch.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Van de Kelft', 'Affiliation': 'Department of Neurosurgery, AZ Nikolaas, Sint-Niklaas and Faculty of Medicine and Health Sciences, University of Antwerp, Antwerpen, Belgium.'}, {'ForeName': 'Sandro', 'Initials': 'S', 'LastName': 'Eustacchio', 'Affiliation': 'Department of Neurosurgery, University Hospital Graz, Graz, Austria.'}, {'ForeName': 'Gerrit Joan', 'Initials': 'GJ', 'LastName': 'Bouma', 'Affiliation': 'Department of Neurosurgery, OLVG Locatie West, Amsterdam, The Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Acta neurochirurgica,['10.1007/s00701-020-04505-4']
1663,33085032,Analysis of subsequent therapy in Japanese patients with hormone receptor‒positive/human epidermal growth factor receptor 2‒negative advanced breast cancer who received palbociclib plus endocrine therapy in PALOMA-2 and -3.,"BACKGROUND


In the double-blind, phase 3 PALOMA-2 and PALOMA-3 studies, palbociclib plus endocrine therapy (ET) demonstrated significant improvement in progression-free survival versus placebo plus ET in patients with hormone receptor‒positive/human epidermal growth factor receptor 2‒negative advanced breast cancer. This analysis assessed subsequent treatment patterns after palbociclib therapy in Japanese patients enrolled in the PALOMA-2 and PALOMA-3 studies.
METHODS


PALOMA-2 included postmenopausal women who had not received prior systemic therapy for advanced disease. PALOMA-3 included pre- or postmenopausal women who had progressed on previous ET. Types of subsequent therapy were assessed, and treatment durations of subsequent therapy were estimated using the Kaplan-Meier method.
RESULTS


Japanese patients were enrolled in PALOMA-2 (n = 46) and PALOMA-3 (n = 35). In both studies, the most common first subsequent therapy was ET (PALOMA-2, 77% in the palbociclib group and 75% in the placebo group; PALOMA-3, 55% and 43%, respectively), followed by chemotherapy (PALOMA-2, 18% and 8%; PALOMA-3, 32% and 57%). The median (95% CI) duration of first subsequent therapy was 6.4 (2.3‒13.9) months with palbociclib plus letrozole and 6.7 (2.8‒13.0) months with placebo plus letrozole in PALOMA-2 and 3.8 (2.4‒5.7) months with palbociclib plus fulvestrant and 9.7 (1.0‒not estimable) months with placebo plus fulvestrant in PALOMA-3.
CONCLUSIONS


The types of first subsequent therapy received by Japanese patients in the palbociclib plus ET and placebo plus ET groups were similar. Further evaluation of subsequent therapy data in the real-world setting is warranted considering the small sample size of this analysis.",2020,The types of first subsequent therapy received by Japanese patients in the palbociclib plus ET and placebo plus ET groups were similar.,"['Japanese patients with hormone receptor‒positive/human epidermal growth factor receptor 2‒negative advanced breast cancer who received', 'patients with hormone receptor‒positive/human epidermal growth factor receptor 2‒negative advanced breast cancer', 'Japanese patients enrolled in the PALOMA-2 and PALOMA-3 studies', 'PALOMA-2 included postmenopausal women who had not received prior systemic therapy for advanced disease', 'PALOMA-3 included pre- or postmenopausal women who had progressed on previous ET', 'Japanese patients']","['placebo plus ET', 'letrozole', 'palbociclib plus endocrine therapy (ET', 'palbociclib plus endocrine therapy', 'palbociclib therapy', 'placebo plus letrozole', 'placebo', 'placebo plus fulvestrant']",[],"[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C1509244', 'cui_str': 'human epidermal growth factor'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C3853822', 'cui_str': 'palbociclib'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0935916', 'cui_str': 'fulvestrant'}]",[],,0.0733096,The types of first subsequent therapy received by Japanese patients in the palbociclib plus ET and placebo plus ET groups were similar.,"[{'ForeName': 'Norikazu', 'Initials': 'N', 'LastName': 'Masuda', 'Affiliation': 'National Hospital Organization Osaka National Hospital, 2-1-14, Hoenzaka, Chuou-ku, Osaka-City, 540-0006, Japan. nmasuda@alpha.ocn.ne.jp.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Mukai', 'Affiliation': 'National Cancer Center Hospital East, 6-5-1, Kashiwanoha, Kashiwa-shi, Chiba, 277-8577, Japan.'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Inoue', 'Affiliation': 'Saitama Cancer Center, 780, Komuro, Ina-machi, Kitaadachi-gun, Saitama, 362-0806, Japan.'}, {'ForeName': 'Yoshiaki', 'Initials': 'Y', 'LastName': 'Rai', 'Affiliation': 'Sagara Hospital, 3-31, Matsubara-cho, Kagoshima City, 892-0833, Japan.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Ohno', 'Affiliation': 'The Cancer Institute Hospital of JFCR, 3-8-31, Ariake, Koto-ku, Tokyo, 135-8550, Japan.'}, {'ForeName': 'Shoichiro', 'Initials': 'S', 'LastName': 'Ohtani', 'Affiliation': 'Hiroshima City Hiroshima Citizens Hospital, 7-33, Motomachi, Naka-ku, Hiroshima, 730-8518, Japan.'}, {'ForeName': 'Chikako', 'Initials': 'C', 'LastName': 'Shimizu', 'Affiliation': 'National Center for Global Health and Medicine, 1-21-1, Toyama, Shinjuku-ku, Tokyo, 162-8655, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Hashigaki', 'Affiliation': 'Pfizer R&D Japan, 3-22-7, Yoyogi, Shibuya-ku, Tokyo, 151-8589, Japan.'}, {'ForeName': 'Yasuaki', 'Initials': 'Y', 'LastName': 'Muramatsu', 'Affiliation': 'Pfizer Japan Inc, 3-22-7, Yoyogi, Shibuya-ku, Tokyo, 151-8589, Japan.'}, {'ForeName': 'Yoshiko', 'Initials': 'Y', 'LastName': 'Umeyama', 'Affiliation': 'Pfizer R&D Japan, 3-22-7, Yoyogi, Shibuya-ku, Tokyo, 151-8589, Japan.'}, {'ForeName': 'Hiroji', 'Initials': 'H', 'LastName': 'Iwata', 'Affiliation': 'Aichi Cancer Center Hospital, 1-1, Kanokoden, Chikusa-ku, Nagoya, 464-8681, Japan.'}, {'ForeName': 'Masakazu', 'Initials': 'M', 'LastName': 'Toi', 'Affiliation': 'Kyoto University Graduate School of Medicine, 54, Kawaharacho, Shogoin, Sakyo-ku, Kyoto, 606-8507, Japan.'}]","Breast cancer (Tokyo, Japan)",['10.1007/s12282-020-01162-4']
1664,33085094,"A single, clinically relevant dose of the GABA B  agonist baclofen impairs visuomotor learning.","KEY POINTS


Baclofen is a GABA B  agonist prescribed as a treatment for spasticity in stroke, brain injury and multiple sclerosis patients, who are often undergoing concurrent motor rehabilitation. Decreasing GABAergic inhibition is a key feature of motor learning and so there is a possibility that GABA agonist drugs, like baclofen, could impair these processes, potentially impacting rehabilitation. Here we examined the effect of 10mg baclofen, in 20 young healthy individuals, and found that the drug impaired retention of visuomotor learning with no significant effect on motor sequence learning. Overall baclofen did not alter TMS-measured GABA B  inhibition, but the change in GABA B  inhibition correlated with aspects of visuomotor learning retention. Further work is needed to investigate whether taking baclofen impacts motor rehabilitation in patients.
ABSTRACT


The GABA B  agonist baclofen is taken daily as a treatment for spasticity by millions of stroke, brain injury and multiple sclerosis patients, many of whom are also undergoing motor rehabilitation. However, multiple studies suggest that decreases in GABA are a key feature of human motor learning (Floyer-Lea et al. 2006; Stagg et al. 2011; Kolasinski et al. 2018), which raises questions about whether drugs increasing GABAergic activity may impair motor learning and rehabilitation. In this double-blind, placebo-controlled study we investigate whether a single 10mg dose of the GABA B  agonist baclofen impaired motor sequence learning and visuomotor learning in 20 young healthy participants of both sexes. Participants trained on visuomotor and sequence learning tasks using their right hand. Transcranial magnetic stimulation (TMS) measures of corticospinal excitability, GABA A  (SICI 2.5ms  ) and GABA B  (LICI 150ms  ) receptor activation were recorded from left M1. Behaviourally, baclofen caused a significant reduction of visuomotor aftereffect (F(1,137.8) = 6.133, p = 0.014) and retention (F(1,130.7) = 4.138, p = 0.044), with no significant changes to sequence learning. There were no overall changes to TMS measured GABAergic inhibition with this low dose of baclofen. This result confirms the causal importance of GABA B  inhibition in mediating visuomotor learning and suggests that chronic baclofen use could negatively impact aspects motor rehabilitation. This article is protected by copyright. All rights reserved.",2020,"Behaviourally, baclofen caused a significant reduction of visuomotor aftereffect (F(1,137.8) = 6.133, p = 0.014) and retention (F(1,130.7) =","['20 young healthy individuals', '20 young healthy participants of both sexes', 'patients']","['Baclofen', 'placebo', 'GABA B  agonist baclofen', 'Transcranial magnetic stimulation (TMS']","['visuomotor aftereffect', 'sequence learning', 'visuomotor learning', 'Overall baclofen', 'motor sequence learning', 'TMS-measured GABA B  inhibition', 'corticospinal excitability, GABA A  (SICI 2.5ms  ) and GABA B  (LICI 150ms  ) receptor activation', 'motor sequence learning and visuomotor learning']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0004609', 'cui_str': 'Baclofen'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0016904', 'cui_str': 'Gamma-aminobutyric acid'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}]","[{'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0004609', 'cui_str': 'Baclofen'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0016904', 'cui_str': 'Gamma-aminobutyric acid'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0235169', 'cui_str': 'Excitability'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}]",20.0,0.0721447,"Behaviourally, baclofen caused a significant reduction of visuomotor aftereffect (F(1,137.8) = 6.133, p = 0.014) and retention (F(1,130.7) =","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Johnstone', 'Affiliation': 'Wellcome Centre for Integrative Neuroimaging, FMRIB, Nuffield Department of Clinical Neurosciences, University of Oxford.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Grigoras', 'Affiliation': 'Wellcome Centre for Integrative Neuroimaging, FMRIB, Nuffield Department of Clinical Neurosciences, University of Oxford.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Petitet', 'Affiliation': 'Wellcome Centre for Integrative Neuroimaging, FMRIB, Nuffield Department of Clinical Neurosciences, University of Oxford.'}, {'ForeName': 'L P', 'Initials': 'LP', 'LastName': 'Capitão', 'Affiliation': 'Department of Psychiatry, University of Oxford.'}, {'ForeName': 'C J', 'Initials': 'CJ', 'LastName': 'Stagg', 'Affiliation': 'Wellcome Centre for Integrative Neuroimaging, FMRIB, Nuffield Department of Clinical Neurosciences, University of Oxford.'}]",The Journal of physiology,['10.1113/JP280378']
1665,33085099,The Novel Use of Point-of-Care Ultrasound to Predict Resting Energy Expenditure in Critically Ill Patients.,"OBJECTIVES


Accurate estimation of a critically ill patient's caloric requirements is essential for a proper nutritional plan. This study aimed to evaluate the use of point-of-care ultrasound (US) to predict the resting energy expenditure (REE) in critically ill patients.
METHODS


In 69 critically ill patients, we measured the REE using indirect calorimetry (REE_IC), muscle layer thicknesses (MLTs), and cardiac output (CO). Muscle thickness was measured at the biceps and the quadriceps muscles. Patients were randomly split into a model development group (n = 46) and a cross-validation group (n = 23). In the model development group, a multiple regression analysis was applied to generate REE using US (REE_US) values. In the cross-validation group, REE was calculated by the REE_US and the resting energy expenditure using the Harris-Benedict equation (REE_HB), and both were compared to the REE_IC.
RESULTS


In the model development group, the REE_US was predicted by the following formula: predicted REE_US (kcal/d) = 206 + 173.5 × CO (L/min) + 137 × MLT (cm) - 230 × (women = 1; men = 0) (R 2  = 0.8; P < .0001). In the cross-validated group, the REE_IC and REE_US values were comparable (mean difference, -66 [-3.3%] kcal/d; P = .14). However, the difference between the mean REE_IC and the mean REE_HB was 455.8 (26%) kcal/d (P < .001). According to a Bland-Altman analysis, the REE_US agreed well with the REE_IC, whereas the REE_HB did not.
CONCLUSIONS


Resting energy expenditure could be estimated from US measurements of MLTs and CO. Our point-of-care US model explains 80% of the change in the REE in critically ill patients.",2020,"In the cross-validated group, the REE_IC and REE_US values were comparable (mean difference, -66","['69 critically ill patients', 'Critically Ill Patients', 'critically ill patients']",['point-of-care ultrasound (US'],"['REE using indirect calorimetry (REE_IC), muscle layer thicknesses (MLTs), and cardiac output (CO', 'Muscle thickness']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0282664', 'cui_str': 'Point-of-Care'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}]","[{'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0006781', 'cui_str': 'Indirect calorimetry'}, {'cui': 'C0225358', 'cui_str': 'Muscularis propria'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}]",69.0,0.0365351,"In the cross-validated group, the REE_IC and REE_US values were comparable (mean difference, -66","[{'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Mukhtar', 'Affiliation': 'Department of Anesthesia and Critical Care Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Abdelghany', 'Affiliation': 'Department of Anesthesia and Critical Care Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Hasanin', 'Affiliation': 'Department of Anesthesia and Critical Care Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Walid', 'Initials': 'W', 'LastName': 'Hamimy', 'Affiliation': 'Department of Anesthesia and Critical Care Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Ayman', 'Initials': 'A', 'LastName': 'Abougabal', 'Affiliation': 'Department of Anesthesia and Critical Care Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Haytham', 'Initials': 'H', 'LastName': 'Nasser', 'Affiliation': 'Department of Radiology, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Allam', 'Initials': 'A', 'LastName': 'Elsayed', 'Affiliation': 'Department of Radiology, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Eslam', 'Initials': 'E', 'LastName': 'Ayman', 'Affiliation': 'Department of Anesthesia and Critical Care Medicine, Cairo University, Cairo, Egypt.'}]",Journal of ultrasound in medicine : official journal of the American Institute of Ultrasound in Medicine,['10.1002/jum.15538']
1666,33085106,When the physical coldness in the viewer's environment leads to identification with a suffering protagonist.,"Based on theories of narrative engagement and embodied cognition, we hypothesised that a fit between the psychological state of a protagonist and the physical sensation of the viewer would enhance the subsequent identification with the protagonist, but not para-social relationship with him (seeing the protagonist as a friend). We also hypothesised that identification and a para-social relationship would lead to distinct effects on attitudes related to the narrative. Participants (N = 60) were randomly assigned to either a warmed or cooled room where they watched a movie clip alone in which a suffering protagonist wanted to undergo euthanasia while his close others wanted him to stay alive. Then, the participants answered a questionnaire measuring their identification and para-social relationship with the protagonist and their attitudes toward euthanasia. In accordance with the hypotheses, the results demonstrated that feeling cold enhanced identification with the suffering protagonist. However, the environmental temperature did not affect the development of para-social relationships. Moreover, identification with the suffering protagonist contributed to acceptance of his attitudes, reflected in more positive views of euthanasia. In contrast, having a para-social relationship with the protagonist resulted in negative attitudes toward euthanasia.",2020,We also hypothesised that identification and a para-social relationship would lead to distinct effects on attitudes related to the narrative.,"['60', 'Participants (N\xa0']",['warmed or cooled room where they watched a movie clip alone'],['development of para-social relationships'],[],"[{'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C0175722', 'cui_str': 'Clip'}, {'cui': 'C0205171', 'cui_str': 'Singular'}]","[{'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0030563', 'cui_str': 'Parity'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}]",60.0,0.0125865,We also hypothesised that identification and a para-social relationship would lead to distinct effects on attitudes related to the narrative.,"[{'ForeName': 'Nurit', 'Initials': 'N', 'LastName': 'Tal-Or', 'Affiliation': 'Department of Communication, University of Haifa, Haifa, Israel.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Razpurker-Apfeld', 'Affiliation': 'Department of Behavioral Sciences, Zefat Academic College, Safed, Israel.'}]",International journal of psychology : Journal international de psychologie,['10.1002/ijop.12722']
1667,33085123,VVI Pacing with normal QRS duration and ventricular function: MOST trial findings relevant to leadless pacemakers.,"BACKGROUND


Leadless pacemakers (LPs) provide ventricular pacing without the risks associated with transvenous leads and device pockets. LPs are appealing for patients who need pacing, but do not need defibrillator or cardiac resynchronization therapy. Most implanted LPs provide right ventricular pacing without atrioventricular synchrony (VVIR mode). The Mode Selection Trial in Sinus Node Dysfunction Trial (MOST) showed similar outcomes in patients randomized to dual chamber (DDDR) vs ventricular pacing (VVIR). We compared outcomes by pacing mode in LP-eligible patients from MOST.
METHODS


Patients enrolled in the MOST study with an LVEF >35%, QRSd <120ms and no history of ventricular arrhythmias or prior implantable cardioverter defibrillators were included (LP-eligible population). Cox proportional hazards models were used to test the association between pacing mode and death, stroke or heart failure hospitalization and atrial fibrillation (AF).
RESULTS


Of the 2,010 patients enrolled in MOST, 1,284 patients (64%) met inclusion criteria. Baseline characteristics were well balanced across included patients randomized to DDDR (N = 630) and VVIR (N = 654). Over four years of follow-up, there was no association between pacing mode and death, stroke or heart failure hospitalization (VVIR HR 1.28 [0.92-1.75]). VVIR pacing was associated with higher risk of AF (HR 1.32 [1.08-1.61], p = 0.007), particularly in patients with no history of AF (HR 2.38 [1.52-3.85], p<0.001).
CONCLUSION


In patients without reduced LVEF or prolonged QRS duration who would be eligible for LP, DDDR and VVIR pacing demonstrated similar rates of death, stroke or heart failure hospitalization; however, VVIR pacing significantly increased the risk of AF development. This article is protected by copyright. All rights reserved.",2020,"VVIR pacing was associated with higher risk of AF (HR 1.32 [1.08-1.61], p = 0.007), particularly in patients with no history of AF (HR 2.38 [1.52-3.85], p<0.001).
","['2,010 patients enrolled in MOST, 1,284 patients (64%) met inclusion criteria', 'LP-eligible patients from MOST', 'Patients enrolled in the MOST study with an LVEF >35%, QRSd <120ms and no history of ventricular arrhythmias or prior implantable cardioverter defibrillators were included (LP-eligible population']","['dual chamber (DDDR) vs ventricular pacing (VVIR', 'VVI Pacing']","['pacing mode and death, stroke or heart failure hospitalization', 'rates of death, stroke or heart failure hospitalization', 'pacing mode and death, stroke or heart failure hospitalization and atrial fibrillation (AF', 'LVEF or prolonged QRS duration']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031222', 'cui_str': 'Personnel Selection'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0428908', 'cui_str': 'Sinus node dysfunction'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0332122', 'cui_str': 'No history of'}, {'cui': 'C0085612', 'cui_str': 'Ventricular arrhythmia'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0162589', 'cui_str': 'Implantable defibrillator'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0562458', 'cui_str': 'Pacing up and down'}]","[{'cui': 'C0287990', 'cui_str': 'Furin'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0429025', 'cui_str': 'QRS complex duration'}]",2010.0,0.0306833,"VVIR pacing was associated with higher risk of AF (HR 1.32 [1.08-1.61], p = 0.007), particularly in patients with no history of AF (HR 2.38 [1.52-3.85], p<0.001).
","[{'ForeName': 'Zak', 'Initials': 'Z', 'LastName': 'Loring', 'Affiliation': 'Division of Cardiology, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'North', 'Affiliation': 'Department of Statistics, North Carolina State University, Raleigh, NC.'}, {'ForeName': 'Anne S', 'Initials': 'AS', 'LastName': 'Hellkamp', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC.'}, {'ForeName': 'Brett D', 'Initials': 'BD', 'LastName': 'Atwater', 'Affiliation': 'Division of Cardiology, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Camille G', 'Initials': 'CG', 'LastName': 'Frazier-Mills', 'Affiliation': 'Division of Cardiology, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Kevin P', 'Initials': 'KP', 'LastName': 'Jackson', 'Affiliation': 'Division of Cardiology, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Sean D', 'Initials': 'SD', 'LastName': 'Pokorney', 'Affiliation': 'Division of Cardiology, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Gervasio A', 'Initials': 'GA', 'LastName': 'Lamas', 'Affiliation': 'Division of Cardiology, Mount Sinai Medical Center, Miami Beach, FL.'}, {'ForeName': 'Jonathan P', 'Initials': 'JP', 'LastName': 'Piccini', 'Affiliation': 'Division of Cardiology, Duke University Medical Center, Durham, NC.'}]",Pacing and clinical electrophysiology : PACE,['10.1111/pace.14100']
1668,33071901,Recognizing Decision-Making Using Eye Movement: A Case Study With Children.,"The use of visual attention for evaluating consumer behavior has become a relevant field in recent years, allowing researchers to understand the decision-making processes beyond classical self-reports. In our research, we focused on using eye-tracking as a method to understand consumer preferences in children. Twenty-eight subjects with ages between 7 and 12 years participated in the experiment. Participants were involved in two consecutive phases. The initial phase consisted of the visualization of a set of stimuli for decision-making in an eight-position layout called Alternative Forced-choice. Then the subjects were asked to freely analyze the set of stimuli, they needed to choose the best in terms of preference. The sample was randomly divided into two groups balanced by gender. One group visualized a set of icons and the other a set of toys. The final phase was an independent assessment of each stimulus viewed in the initial phase in terms of liking/disliking using a 7-point Likert scale. Sixty-four stimuli were designed for each of the groups. The visual attention was measured using a non-obstructive eye-tracking device. The results revealed two novel insights. Firstly, the time of fixation during the last four visits to each stimulus before the decision-making instant allows us to recognize the icon or toy chosen from the eight alternatives with a 71.2 and 67.2% of accuracy, respectively. The result supports the use of visual attention measurements as an implicit tool to analyze decision-making and preferences in children. Secondly, eye movement and the choice of liking/disliking choice are influenced by stimuli design dimensions. The icon observation results revealed how gender samples have different fixation and different visit times which depend on stimuli design dimension. The toy observations results revealed how the materials determinate the largest amount fixations, also, the visit times were differentiated by gender. This research presents a relevant empirical data to understand the decision-making phenomenon by analyzing eye movement behavior. The presented method can be applied to recognize the choice likelihood between several alternatives. Finally, children's opinions represent an extra difficulty judgment to be determined, and the eye-tracking technique seen as an implicit measure to tackle it.",2020,The final phase was an independent assessment of each stimulus viewed in the initial phase in terms of liking/disliking using a 7-point Likert scale.,"['children', 'Twenty-eight subjects with ages between 7 and 12 years participated in the experiment']",['Recognizing Decision-Making Using Eye Movement'],['visual attention'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0015413', 'cui_str': 'Eye Movements'}]","[{'cui': 'C0589102', 'cui_str': 'Visual attention'}]",28.0,0.0115745,The final phase was an independent assessment of each stimulus viewed in the initial phase in terms of liking/disliking using a 7-point Likert scale.,"[{'ForeName': 'Juan-Carlos', 'Initials': 'JC', 'LastName': 'Rojas', 'Affiliation': 'Escuela de Arquitectura, Arte y Diseño, Tecnologico de Monterrey, Monterrey, Mexico.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Marín-Morales', 'Affiliation': 'I3B - Instituto de Investigación e Innovación en Bioingeniería, Universitat Politècnica de València, Valencia, Spain.'}, {'ForeName': 'Jose Manuel', 'Initials': 'JM', 'LastName': 'Ausín Azofra', 'Affiliation': 'I3B - Instituto de Investigación e Innovación en Bioingeniería, Universitat Politècnica de València, Valencia, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Contero', 'Affiliation': 'I3B - Instituto de Investigación e Innovación en Bioingeniería, Universitat Politècnica de València, Valencia, Spain.'}]",Frontiers in psychology,['10.3389/fpsyg.2020.570470']
1669,33072183,Educational supportive group therapy and the quality of life of hemodialysis patients.,"Background


In addition to physical, mental, and social condition, ESRD and hemodialysis affect the quality of life of patients as well. Psychotherapy and non-pharmaceutical interventions are effective measures to add meaning to life, create a goal and motivation in life, and improve the quality of life in chronic patients. The effect of educational and supportive group therapy on the quality of life (QOL) of hemodialysis patients was examined.
Methods


The study was carried out as an interventional quasi-experimental study with the participation of 64 patients who were selected through convenience sampling and based on the patient's hemodialysis days (Saturday, Monday, and Wednesday patients as an experimental group and Sunday, Tuesday, and Thursday patients as a control group). There were 32 patients in each group. The experimental group received eight 50 min sessions including two sessions per week. The control group received the normal interventions. The participants were assessed using a demographics form and Kidney Disease Quality of Life Short Form before, immediately after, and 1 month after the intervention. The collected data was analyzed using SPSS (v.24).
Results


The mean QOL scores of the experimental group before, immediately after, and 4 weeks after the intervention were 36.99, 43.3, and 44.9 respectively. Those of the control group were 36.39, 37.2, and 37.1 respectively. There was no significant difference between the two groups before the intervention ( P  > 0.05); however, the difference between the two groups was significant immediately after and 4 weeks after the intervention ( P  = 0.0001). The trend of score change in the experimental group was also significant ( p  < 0.05), and Tukey ad-hoc test showed significant differences between the scores before intervention and those immediately after and 4 weeks after the intervention ( p  < 0.05).
Conclusion


In general, educational and supportive group therapy can expand the interpersonal relationships of hemodialysis patients and positively affect their quality of life.",2020,"In general, educational and supportive group therapy can expand the interpersonal relationships of hemodialysis patients and positively affect their quality of life.","['hemodialysis patients', 'chronic patients', ""64 patients who were selected through convenience sampling and based on the patient's hemodialysis days (Saturday, Monday, and Wednesday patients as an experimental group and Sunday, Tuesday, and Thursday patients as a control group""]","['Educational supportive group therapy', 'normal interventions', 'educational and supportive group therapy', 'Psychotherapy and non-pharmaceutical interventions']","['quality of life (QOL', 'quality of life', 'mean QOL scores']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0585030', 'cui_str': 'Saturday'}, {'cui': 'C0585024', 'cui_str': 'Monday'}, {'cui': 'C0585027', 'cui_str': 'Wednesday'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0585025', 'cui_str': 'Sunday'}, {'cui': 'C0585026', 'cui_str': 'Tuesday'}, {'cui': 'C0585028', 'cui_str': 'Thursday'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0033971', 'cui_str': 'Group psychotherapy'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0013058', 'cui_str': 'Pharmaceutical dose form'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0215464,"In general, educational and supportive group therapy can expand the interpersonal relationships of hemodialysis patients and positively affect their quality of life.","[{'ForeName': 'Sajad', 'Initials': 'S', 'LastName': 'Mansouri', 'Affiliation': 'Department of Geriatric and Psychiatric Nursing, School of Nursing and Midwifery, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Jalali', 'Affiliation': 'Substance Abuse Prevention Research Center, Research Institute for Health, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Rahmati', 'Affiliation': 'Department of Geriatric and Psychiatric Nursing, School of Nursing and Midwifery, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Nader', 'Initials': 'N', 'LastName': 'Salari', 'Affiliation': 'Department of Biostatistics, Faculty of Public Health, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}]",BioPsychoSocial medicine,['10.1186/s13030-020-00200-z']
1670,33072186,Effect of intraoperative dexmedetomidine infusion during functional endoscopic sinus surgery: a prospective cohort study.,"Background


Dexmedetomidine, an α2 agonist, has well-known anesthetic and analgesic-sparing effects. We designed this study to evaluate the effect of intraoperative dexmedetomidine infusion on intra operative blood loss and postoperative pain in functional endoscopic sinus surgery.
Methods


This prospective cohort study included 90 patients planning to undergo endoscopic sinus surgery, who were randomly divided into three groups. 2 to 2.5 mg/kg of propofol was used in all groups to induce anesthesia. One group received dexmedetomidine 0.2 μg/kg per hour infusion whereas the other group received dexmedetomidine 0.5 μg/kg per hour infusion. The control group received normal saline infusion.
Results


The mean age of patients was 41.02 ± 11.93. 33 patients in the dexmedetomidine 0.2 μg/kg/h group, 30 patients in the dexmedetomidine 0.5 μg/kg/h group and 27 patients in the placebo group. The lowest amount of bleeding was related to the dexmedetomidine 0.5 μg/kg/h group. The volume of bleeding between the three groups was significantly different ( p  = 0.012). The satisfaction of the surgeon in the dexmedetomidine 0.5 μg/kg/h group was more than other groups. There was a significant relationship between the satisfaction of the surgeon and the treatment groups ( p  < 0.001). The lowest duration of surgery was related to the dexmedetomidine 0.2 μg/kg/h group. The most Trinitroglycerin (TNG) consumption was in the placebo group and the highest dose of labetalol was in the dexmedetomidine 0.5 μg/kg/h group. There was no significant difference in the TNG and labetalol consumption between three groups. The lowest consumption of morphine and pethidine in the dexmedetomidine 0.5 μg/kg/h group.
Conclusions


Infusion of dexmedetomidine 0.5 μg/kg/h decreased blood loss and consumption of morphine and pethidine in patients who underwent endoscopic sinus surgery.",2020,There was a significant relationship between the satisfaction of the surgeon and the treatment groups ( p  < 0.001).,"['functional endoscopic sinus surgery', '33 patients in the', '90 patients planning to undergo endoscopic sinus surgery', 'patients who underwent endoscopic sinus surgery']","['dexmedetomidine 0.5\u2009μg/kg per hour infusion', 'normal saline infusion', 'morphine and pethidine', 'propofol', 'intraoperative dexmedetomidine infusion', 'pethidine', 'Dexmedetomidine', 'placebo', 'dexmedetomidine', 'labetalol']","['blood loss and consumption of morphine', 'lowest amount of bleeding', 'TNG and labetalol consumption', 'Trinitroglycerin (TNG) consumption', 'volume of bleeding', 'lowest duration of surgery']","[{'cui': 'C0442968', 'cui_str': 'Functional endoscopic sinus surgery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0748725', 'cui_str': 'Sinus operation'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0564385', 'cui_str': '/hour'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0025376', 'cui_str': 'Meperidine'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0022860', 'cui_str': 'Labetalol'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0022860', 'cui_str': 'Labetalol'}, {'cui': 'C0017887', 'cui_str': 'Nitroglycerin'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]",90.0,0.11233,There was a significant relationship between the satisfaction of the surgeon and the treatment groups ( p  < 0.001).,"[{'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Fazel', 'Affiliation': 'Department of Radiology, Faculty of Medicine, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Zeynab Sadat', 'Initials': 'ZS', 'LastName': 'Ahmadi', 'Affiliation': 'Research Center of Biochemistry and Nutrition in Metabolic Disorder, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Akbari', 'Affiliation': 'Department of Radiology, Faculty of Medicine, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Fahimeh', 'Initials': 'F', 'LastName': 'Abam', 'Affiliation': 'Department of Radiology, Faculty of Medicine, Kashan University of Medical Sciences, Kashan, Iran.'}]",Patient safety in surgery,['10.1186/s13037-020-00264-4']
1671,33072188,The Effect of Early Treatment with Intravenous Magnesium Sulfate on the Incidence of Cardiac Comorbidities in Hospitalized Stroke Patients.,"Background


Cardiac adverse events are common among patients presenting with acute stroke and contribute to overall morbidity and mortality. Prophylactic measures for the reduction of cardiac adverse events in hospitalized stroke patients have not been well understood. We sought to investigate the effect of early initiation of high-dose intravenous magnesium sulfate on cardiac adverse events in stroke patients.
Methods


This is a secondary analysis of the prehospital Field Administration of Stroke Therapy-Magnesium (FAST-MAG) randomized phase-3 clinical trial, conducted from 2005-2013. Consecutive patients with suspected acute stroke and a serum magnesium level within 72 hours of enrollment were selected. Twenty grams of magnesium sulfate or placebo was administered in the ambulance starting with a 15-minute loading dose intravenous infusion followed by a 24-hour maintenance infusion in the hospital.
Results


Among 1126 patients included in the analysis of this study, 809 (71.8%) patients had ischemic stroke, 277 (24.6%) had hemorrhagic stroke, and 39 (3.5%) with stroke mimics. The mean age was 69.5 (SD13.4) and 42% were female. 565 (50.2%) received magnesium treatment, and 561 (49.8%) received placebo. 254 (22.6%) patients achieved the target, and 872 (77.4%) did not achieve the target, regardless of their treatment group. Among 1126 patients, 159 (14.1%) had at least one CAE. Treatment with magnesium was not associated with fewer cardiac adverse events. A multivariate binary logistic regression for predictors of CAEs showed a positive association of older age and frequency of CAEs ( R  = 1.04, 95% CI 1.03-1.06,  p  < 0.0001). Measures of early and 90-day outcomes did not differ significantly between the magnesium and placebo groups among patients who had CAEs.
Conclusion


Treatment of acute stroke patients with magnesium did not result in a reduction in the number or severity of cardiac serious adverse events.",2020,"Measures of early and 90-day outcomes did not differ significantly between the magnesium and placebo groups among patients who had CAEs.
","['1126 patients, 159 (14.1%) had at least one CAE', 'Consecutive patients with suspected acute stroke and a serum magnesium level within 72 hours of enrollment were selected', 'patients presenting with acute stroke', 'Hospitalized Stroke Patients', 'stroke patients', 'patients who had CAEs', '1126 patients included in the analysis of this study, 809 (71.8%) patients had ischemic stroke, 277 (24.6%) had hemorrhagic stroke, and 39 (3.5%) with stroke mimics', 'hospitalized stroke patients', 'acute stroke patients with', 'The mean age was 69.5 (SD13.4) and 42% were female']","['magnesium treatment', 'magnesium', 'Stroke Therapy-Magnesium (FAST-MAG', 'placebo', 'Intravenous Magnesium Sulfate', 'magnesium sulfate or placebo', 'magnesium sulfate', 'magnesium and placebo']","['Incidence of Cardiac Comorbidities', 'number or severity of cardiac serious adverse events', 'cardiac adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0108844', 'cui_str': 'CDE protocol'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0751956', 'cui_str': 'Acute stroke'}, {'cui': 'C0202125', 'cui_str': 'Magnesium measurement, serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1292423', 'cui_str': '72 hours'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0553692', 'cui_str': 'Haemorrhagic stroke'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.489966,"Measures of early and 90-day outcomes did not differ significantly between the magnesium and placebo groups among patients who had CAEs.
","[{'ForeName': 'Kameron', 'Initials': 'K', 'LastName': 'Bechler', 'Affiliation': 'Keck School of Medicine, USA.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Shkirkova', 'Affiliation': 'Zilkha Neurogenetic Institute, University of Southern California, USA.'}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Saver', 'Affiliation': 'Stroke Center and Department of Neurology, University of California, Los Angeles, USA.'}, {'ForeName': 'Sidney', 'Initials': 'S', 'LastName': 'Starkman', 'Affiliation': 'Stroke Center and Department of Neurology, University of California, Los Angeles, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Hamilton', 'Affiliation': 'Stanford University, USA.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Liebeskind', 'Affiliation': 'Stroke Center and Department of Neurology, University of California, Los Angeles, USA.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Eckstein', 'Affiliation': 'Department of Neurology, University of Southern California, USA.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Stratton', 'Affiliation': 'Stroke Center and Department of Neurology, University of California, Los Angeles, USA.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Pratt', 'Affiliation': 'Stroke Center and Department of Neurology, University of California, Los Angeles, USA.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Conwit', 'Affiliation': 'Division of Extramural Research, NIH/NINDS, USA.'}, {'ForeName': 'Nerses', 'Initials': 'N', 'LastName': 'Sanossian', 'Affiliation': 'Keck School of Medicine, USA.'}]",Cardiovascular therapeutics,['10.1155/2020/1494506']
1672,33072215,Comparing Cooperative Flipped Learning with Individual Flipped Learning in a Biochemistry Course.,"The aim of this study was to compare a cooperative flipped learning method with an individual flipped learning method in a biochemistry course. In a quasi-experiment, convenience sampling was employed to select 61 biochemistry students, who were then randomly divided into three groups. The experimental groups were trained separately using the cooperative flipped learning and individual flipped learning methods in seven sessions. The control group was trained using the conventional method. The groups were given teacher-made academic achievement tests, used as pretest and posttest. The ANCOVA test was employed to analyze data. According to the results, the cooperative flipped learning method improved academic performance more than the individual flipped learning method in the posttest scores. The results also indicated that the flipped learning implementation both outside and inside the classroom has effects on learning. In fact, the optimal implementation of flipped learning improves in-depth learning to solve problems and carry out experiments in a biochemistry course.",2020,"According to the results, the cooperative flipped learning method improved academic performance more than the individual flipped learning method in the posttest scores.",['61 biochemistry students'],[],['academic performance'],"[{'cui': 'C0005477', 'cui_str': 'Biochemistry'}, {'cui': 'C0038492', 'cui_str': 'Student'}]",[],"[{'cui': 'C0036373', 'cui_str': 'Academic Test Performance'}]",,0.0125993,"According to the results, the cooperative flipped learning method improved academic performance more than the individual flipped learning method in the posttest scores.","[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Jafarkhani', 'Affiliation': ""Department of Educational Technology, Faculty of Psychology and Educational Sciences,Allameh Tabataba'i University, Tehran, Iran.""}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Jamebozorg', 'Affiliation': ""Department of Educational Technology, Faculty of Psychology and Educational Sciences,Allameh Tabataba'i University, Tehran, Iran.""}]",Journal of medicine and life,['10.25122/jml-2019-0149']
1673,33072220,Comparison of the Laryngoscopic View using Macintosh and Miller Blades in Children Less than Four Years Old.,"This study aimed to compare Miller and Macintosh laryngoscopes in zero to 4-year-old children. A total of 72 children with a score of I and II, according to the American Society of Anesthesiologists (ASA) physical status classification, who were candidates for elective surgery with general anesthesia and tracheal intubation were enrolled in the study. The children were divided into two equal groups (36 persons) according to used laryngoscope: Miller laryngoscope (group 1) and Macintosh laryngoscope (group 2). Observations and all laryngoscopies were performed by a single experienced anesthesiologist. Heart rate, systolic blood pressure, non-invasive arterial blood pressure, and hemoglobin saturation were measured and recorded. The number of endotracheal intubation attempts and complications were also recorded for both groups. In terms of gender, the first group consisted of 88.9% boys and 11.1% girls, and the second group consisted of 66.6% boys and 33.3% girls (p-value=0.05). The mean age was 16.7 months in the first group and 17.7 months in the second group (p-value=0.5). The mean weight of the children was 16988.5 g and 16300 g in the Miller and Macintosh groups, respectively (p-value=0.9). Regarding the Cormack-Lehane classification system, 5 patients were classified as grade 1 (13.9%), 14 patients as grade 2 (38.9%), 15 patients as grade 3 (41.7%), and 2 patients as grade 4 (5.6%) in the Macintosh group. In contrast, in the Miller group, 5 patients were classified as grade 1 (13.9%), 27 patients as grade 2 (75%), and 4 patients as grade 3 (11.1%) (p-value=0.004). These results can provide more data about the tracheal intubation method with the Macintosh and Miller laryngoscopes, the ease of intubation, and the best laryngoscopic view with each blade.",2020,The mean age was 16.7 months in the first group and 17.7 months in the second group (p-value=0.5).,"['Children Less than Four Years Old', 'zero to 4-year-old children', '72 children with a score of I and II, according to the American Society of Anesthesiologists (ASA) physical status classification, who were candidates for elective surgery with general anesthesia and tracheal intubation were enrolled in the study']","['laryngoscope: Miller laryngoscope (group 1) and Macintosh laryngoscope', 'Laryngoscopic View using Macintosh and Miller Blades']","['mean weight', 'Heart rate, systolic blood pressure, non-invasive arterial blood pressure, and hemoglobin saturation', 'number of endotracheal intubation attempts and complications']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0919414', 'cui_str': '0'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0180453', 'cui_str': 'Laryngoscope'}, {'cui': 'C0402830', 'cui_str': 'Miller'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C2948008', 'cui_str': 'Blade'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C1272641', 'cui_str': 'Systemic arterial pressure'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",72.0,0.0163621,The mean age was 16.7 months in the first group and 17.7 months in the second group (p-value=0.5).,"[{'ForeName': 'Alireza Ebrahim', 'Initials': 'AE', 'LastName': 'Soltani', 'Affiliation': ""Anaesthesiology Department, Children's Hospital Medical Centre, Tehran University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Anahid', 'Initials': 'A', 'LastName': 'Maleki', 'Affiliation': ""Anaesthesiology Department, Children's Hospital Medical Centre, Tehran University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Ebrahim', 'Initials': 'E', 'LastName': 'Espahbodi', 'Affiliation': ""Anaesthesiology Department, Children's Hospital Medical Centre, Tehran University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Mehrdad', 'Initials': 'M', 'LastName': 'Goudarzi', 'Affiliation': ""Anaesthesiology Department, Children's Hospital Medical Centre, Tehran University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Parastou', 'Initials': 'P', 'LastName': 'Ariana', 'Affiliation': ""Anaesthesiology Department, Children's Hospital Medical Centre, Tehran University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Takzare', 'Affiliation': ""Anaesthesiology Department, Children's Hospital Medical Centre, Tehran University of Medical Sciences, Tehran, Iran.""}]",Journal of medicine and life,['10.25122/jml-2020-0039']
1674,33072395,Does synbiotic supplementation affect the quality of life in children with cystic fibrosis? A pilot randomized controlled clinical trial.,"Background


There is no clinical trial that assesses the effect synbiotic supplementation on HRQOL in CF children. Considering the importance of HRQOL as an essential primary outcome and determinant of therapeutic benefit in chronic diseases like cystic fibrosis, the present clinical trial aimed to determine the efficacy of synbiotic supplementation on HRQOL in children with CF.
Methods


In the present double-blind randomized clinical trial, 40 CF children were randomly allocated to the two groups. The intervention group was supplemented with synbiotics supplements and the patients in the placebo group received maltodextrin for 6 months. Demographic data and information about antibiotic use were recorded using the questionnaire. The health-related quality of life was assessed using the Persian version of quality of life inventory questionnaires. Paired t-test and ANCOVA were used for statistical analysis.
Results


Totally, 36 participants completed the trial. The mean score of HRQOL was 76.34 ± 17.33. There were no significant differences between synbiotic and placebo groups regarding baseline demographic and quality of life characteristics. Compared with baseline values, the mean total score and subscores of quality of life did not change significantly after synbiotic and placebo supplementation ( p  > 0.05). Moreover, the results of ANCOVA showed that there were no significant differences between the two groups regarding the post-trial value of HRQOL total score and subscores.
Conclusion


According to results, six-month supplementation with synbiotic did not have a significant effect on the HRQOL in children with CF. However, further studies with larger sample sizes and using more disease-specific questionnaires are needed for a more precise conclusion.The protocol of the study was registered at Iranian registry clinical trials (Registration code: IRCT2017011732004N1; Registration date: 2017-02-14).",2020,"Compared with baseline values, the mean total score and subscores of quality of life did not change significantly after synbiotic and placebo supplementation ( p  > 0.05).","['40 CF children', '36 participants completed the trial', 'children with CF', 'CF children', 'children with cystic fibrosis', 'chronic diseases like cystic fibrosis']","['synbiotic supplementation', 'synbiotics supplements', 'synbiotic and placebo', 'placebo', 'maltodextrin']","['HRQOL', 'baseline demographic and quality of life characteristics', 'health-related quality of life', 'mean score of HRQOL', 'mean total score and subscores of quality of life', 'Persian version of quality of life inventory questionnaires', 'quality of life', 'HRQOL total score and subscores']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}]","[{'cui': 'C2936470', 'cui_str': 'Synbiotics'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}]","[{'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0031188', 'cui_str': 'Persian language'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",40.0,0.494687,"Compared with baseline values, the mean total score and subscores of quality of life did not change significantly after synbiotic and placebo supplementation ( p  > 0.05).","[{'ForeName': 'Nemat', 'Initials': 'N', 'LastName': 'Bilan', 'Affiliation': 'Pediatric Health Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Effat', 'Initials': 'E', 'LastName': 'Marefat', 'Affiliation': 'Pediatric Health Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Nikniaz', 'Affiliation': 'Tabriz Health Services Management Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Mahdieh', 'Initials': 'M', 'LastName': 'Abbasalizad Farhangi', 'Affiliation': 'Drug applied research center, Tabriz University of medical sciences, Tabriz, Iran.'}, {'ForeName': 'Zeinab', 'Initials': 'Z', 'LastName': 'Nikniaz', 'Affiliation': 'Liver and Gastrointestinal Diseases Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}]",BMC nutrition,['10.1186/s40795-020-00373-4']
1675,33072396,Weekly group tummy time classes are feasible and acceptable to mothers with infants: a pilot cluster randomized controlled trial.,"Background


The World Health Organization recommends 30 min of tummy time daily for improved motor development and reduced likelihood of plagiocephaly. As only 30% of infants meet this recommendation, parents require strategies and support to increase this proportion.
Methods


The aim of this study was to determine the feasibility, acceptability, and potential efficacy of a group intervention to promote tummy time. The design is a cluster randomized controlled trial with concealed allocation, assessor blinding, and intention-to-treat analysis. Five groups of healthy infants ( N  = 35, baseline mean (SD) age 5.9 (2.8) weeks) and their mothers attending local mother's groups (Australia) were randomly allocated to the intervention or control group. The intervention group received group tummy time classes in addition to usual care. The control group received usual care with their child and family health nurse. Primary outcomes were intervention feasibility and acceptability. Secondary outcomes were tummy time duration (accelerometry), adherence to physical activity guidelines, head shape, and motor development. Measures were taken at baseline, post-intervention, and when infants were 6 months of age. Analyses were by linear mixed models and Cohen's  d  statistic.
Results


Recruitment, retention, and collection of objective data met feasibility targets. Acceptability was also met with intervention mothers reporting the information, goal planning, and handouts significantly more useful and relevant than control group mothers ( p  < 0.01). Moderate effect sizes were also found at post-intervention for tummy time duration, adherence to physical activity guidelines and infant ability in prone and supine favoring the intervention group (intervention infants had a mean of 30 min and 30% adherence to guidelines (95% CI 0 to 60.6 min) compared to the control infants who had a mean of 16.6 min and 13% adherence to the guidelines (95% CI 0 to 42.1 min, Cohen's  d  = 0.5). Limitations were the small sample size, 4-week intervention, limited accelerometer use, and a homogenous sample of participants.
Conclusion


Group tummy time classes delivered in a mother's group setting were shown to be feasible and acceptable. A larger randomized controlled trial is warranted.
Trial registration


ANZCTR, ACTRN12617001298303p. Registered 11 September 2017.",2020,"Moderate effect sizes were also found at post-intervention for tummy time duration, adherence to physical activity guidelines and infant ability in prone and supine favoring the intervention group (intervention infants had a mean of 30 min and 30% adherence to guidelines (95% CI 0 to 60.6 min) compared to the control infants who had a mean of 16.6 min and 13% adherence to the guidelines (95% CI 0 to 42.1 min, Cohen's  d  = 0.5).","['mothers with infants', ""Five groups of healthy infants ( N  = 35, baseline mean (SD) age 5.9 (2.8) weeks) and their mothers attending local mother's groups (Australia""]","['usual care with their child and family health nurse', 'intervention group received group tummy time classes in addition to usual care']","['intervention feasibility and acceptability', 'feasibility, acceptability, and potential efficacy', 'Acceptability', 'tummy time duration (accelerometry), adherence to physical activity guidelines, head shape, and motor development', 'tummy time duration, adherence to physical activity guidelines and infant ability in prone and supine', 'motor development and reduced likelihood of plagiocephaly']","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0600220', 'cui_str': 'Family health status'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0033422', 'cui_str': 'Prone body position'}, {'cui': 'C0038846', 'cui_str': 'Supine body position'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0265529', 'cui_str': 'Plagiocephaly'}]",,0.133351,"Moderate effect sizes were also found at post-intervention for tummy time duration, adherence to physical activity guidelines and infant ability in prone and supine favoring the intervention group (intervention infants had a mean of 30 min and 30% adherence to guidelines (95% CI 0 to 60.6 min) compared to the control infants who had a mean of 16.6 min and 13% adherence to the guidelines (95% CI 0 to 42.1 min, Cohen's  d  = 0.5).","[{'ForeName': 'Lyndel', 'Initials': 'L', 'LastName': 'Hewitt', 'Affiliation': 'Early Start, Faculty of Social Sciences, University of Wollongong, Wollongong, New South Wales 2522 Australia.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Stephens', 'Affiliation': 'Early Start, Faculty of Social Sciences, University of Wollongong, Wollongong, New South Wales 2522 Australia.'}, {'ForeName': 'Abbe', 'Initials': 'A', 'LastName': 'Spencer', 'Affiliation': 'Illawarra Shoalhaven Local Health District, Illawarra and Shoalhaven Regions, New South Wales Australia.'}, {'ForeName': 'Rebecca M', 'Initials': 'RM', 'LastName': 'Stanley', 'Affiliation': 'Early Start, Faculty of Social Sciences, University of Wollongong, Wollongong, New South Wales 2522 Australia.'}, {'ForeName': 'Anthony D', 'Initials': 'AD', 'LastName': 'Okely', 'Affiliation': 'Early Start, Faculty of Social Sciences, University of Wollongong, Wollongong, New South Wales 2522 Australia.'}]",Pilot and feasibility studies,['10.1186/s40814-020-00695-x']
1676,33072397,Contextual interference in children with brain lesions: protocol of a pilot study investigating blocked vs. random practice order of an upper limb robotic exergame.,"Background


If adults practice several motor tasks together, random practice leads to better transfer and retention compared to blocked practice. Knowledge about this contextual interference (CI) effect could be valuable to improve neurorehabilitation of children. We present the protocol of a randomised controlled pilot study investigating the feasibility of blocked practice vs. random practice of robot-assisted upper limb reaching in children with brain lesions undergoing neurorehabilitation.
Methods


Children with affected upper limb function due to congenital or acquired brain lesions undergoing neurorehabilitation will be recruited for a randomised controlled pilot study with a 3-week procedure. In the control week (1), two assessment blocks (robot-assisted reaching tasks, Melbourne assessment 2, subscale fluency), 2 days apart, take place. In the practice week (2), participants are randomly allocated to blocked practice or random practice and perform 480 reaching and backward movements in the horizontal and vertical plane using exergaming with an exoskeleton robot per day during three consecutive days. Assessments are performed before, directly after and 1 day after the practice sessions. In the follow-up week (3), participants perform the assessments 1 week after the final practice session. The primary outcome is the immediate transfer of the Melbourne Assessment 2, subscale fluency. Secondary outcomes are the immediate retention, 1-day and 1-week delayed transfer and retention and acquisition during the practice sessions. We will evaluate the feasibility of the inclusion criteria, the recruitment rate, the scheduling procedure, the randomisation procedure, the procedure for the participants, the handling of the robot, the handling of the amount of data, the choice of the outcome measures and the influence of other therapies. Furthermore, we will perform a power calculation using the data to estimate the sample size for the main trial.
Discussion


The protocol of the pilot study is a first step towards a future main randomised controlled trial. This low risk pilot study might induce some benefits for the participants. However, we need to place its results into perspective, especially concerning the generalisability, as it remains questionable whether improving reaching constrained within a robotic device will ameliorate daily life reaching tasks.
Trial registration


ClinicalTrials.gov Identifier: NCT02443857.",2020,"Secondary outcomes are the immediate retention, 1-day and 1-week delayed transfer and retention and acquisition during the practice sessions.","['Methods\n\n\nChildren with affected upper limb function due to congenital or acquired brain lesions undergoing neurorehabilitation', 'children with brain lesions', 'children with brain lesions undergoing neurorehabilitation']","['blocked practice or random practice and perform 480 reaching and backward movements in the horizontal and vertical plane using exergaming with an exoskeleton robot', 'blocked practice vs. random practice of robot-assisted upper limb reaching']","['immediate retention, 1-day and 1-week delayed transfer and retention and acquisition during the practice sessions', 'Contextual interference', 'immediate transfer of the Melbourne Assessment 2, subscale fluency']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0392760', 'cui_str': 'Affecting'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0009678', 'cui_str': 'congenital'}, {'cui': 'C0439661', 'cui_str': 'Acquired'}, {'cui': 'C0221505', 'cui_str': 'Lesion of brain'}, {'cui': 'C0204096', 'cui_str': 'Neurological rehabilitation'}]","[{'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C4319609', 'cui_str': '480'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0439781', 'cui_str': 'Backward'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0439790', 'cui_str': 'Horizontal and vertical'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",,0.0741595,"Secondary outcomes are the immediate retention, 1-day and 1-week delayed transfer and retention and acquisition during the practice sessions.","[{'ForeName': 'Judith V', 'Initials': 'JV', 'LastName': 'Graser', 'Affiliation': ""Research Department, Swiss Children's Rehab, University Children's Hospital Zurich, Mühlebergstrasse 104, 8910 Affoltern am Albis, Switzerland.""}, {'ForeName': 'Caroline H G', 'Initials': 'CHG', 'LastName': 'Bastiaenen', 'Affiliation': 'Research Group Function, Participation and Rehabilitation CAPHRI, Department of Epidemiology, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Urs', 'Initials': 'U', 'LastName': 'Keller', 'Affiliation': ""Research Department, Swiss Children's Rehab, University Children's Hospital Zurich, Mühlebergstrasse 104, 8910 Affoltern am Albis, Switzerland.""}, {'ForeName': 'Hubertus J A', 'Initials': 'HJA', 'LastName': 'van Hedel', 'Affiliation': ""Research Department, Swiss Children's Rehab, University Children's Hospital Zurich, Mühlebergstrasse 104, 8910 Affoltern am Albis, Switzerland.""}]",Pilot and feasibility studies,['10.1186/s40814-020-00694-y']
1677,33072415,Comparing the Therapeutic Effects of  Aloe vera  and Olive Oil Combination Cream versus Topical Betamethasone for Atopic Dermatitis: A Randomized Double-blind Clinical Trial.,"Objectives


Atopic dermatitis (AD) is a prevalent and chronic, pruritic inflammatory skin condition that can influence all age groups. AD is associated with a poor health-related quality of life. This randomized clinical trial was performed to compare the effectiveness of Olivederma (combination of  aloe vera  and virgin olive oil) or betamethasone regarding disease severity, quality of life, serum IgE and eosinophil count.
Methods


Thirty-six AD patients were randomly allocated to topical Olivederma or betamethasone, and were followed for 6 weeks.
Results


Total SCORAD severity scores showed significant decrease in both groups, while it was more prominent in Olivederma group (64.5% improvement in Olivederma vs. 13.5% improvement in Betamethasone, p-value < 0.001). Quality of life (DLQI questionnaire) of AD patients was significantly improved after 6 weeks treatment with Betamethasone (22.3%, p < 0.001) and Olivederma (60.7%, p-value < 0.001). Olivederma group showed a significantly lower DLQI score in comparison with Betamethasone treated patients after 6 weeks of therapy (p < 0.001). Improvements in eosinophil count and serum IgE was observed.
Conclusion


In summary, this study shows that Olivederma is superior to topical Betamethasone after 6 weeks of therapy with regard to disease severity, quality of life and eosinophil count.",2020,"Quality of life (DLQI questionnaire) of AD patients was significantly improved after 6 weeks treatment with Betamethasone (22.3%, p < 0.001) and Olivederma (60.7%, p-value < 0.001).","['Methods\n\n\nThirty-six AD patients', 'Atopic Dermatitis']","['topical Betamethasone', 'betamethasone', 'Aloe vera  and Olive Oil Combination Cream', 'topical Olivederma or betamethasone', 'Topical Betamethasone', 'Olivederma (combination of  aloe vera  and virgin olive oil', 'Betamethasone']","['disease severity, quality of life and eosinophil count', 'Total SCORAD severity scores', 'DLQI score', 'Quality of life (DLQI questionnaire', 'eosinophil count and serum IgE', 'disease severity, quality of life, serum IgE and eosinophil count', 'Olivederma']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0005308', 'cui_str': 'Betamethasone'}, {'cui': 'C0718405', 'cui_str': 'Aloe vera'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0555061', 'cui_str': 'Virgin'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0200638', 'cui_str': 'Eosinophil count'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0020846', 'cui_str': 'Immunoglobulin E'}]",36.0,0.151335,"Quality of life (DLQI questionnaire) of AD patients was significantly improved after 6 weeks treatment with Betamethasone (22.3%, p < 0.001) and Olivederma (60.7%, p-value < 0.001).","[{'ForeName': 'Yunes', 'Initials': 'Y', 'LastName': 'Panahi', 'Affiliation': 'Pharmacotherapy Department, Faculty of Pharmacy, Baqiyatallah University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Nassim', 'Initials': 'N', 'LastName': 'Rastgar', 'Affiliation': 'Department of Pharmaceutics, Faculty of Pharmacy, Pharmaceutical Science Branch, Islamic Azad University, Tehran, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Zamani', 'Affiliation': 'Pharmacotherapy Department, Faculty of Pharmacy, Baqiyatallah University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Amirhossein', 'Initials': 'A', 'LastName': 'Sahebkar', 'Affiliation': 'Halal Research Center of IRI, FDA, Tehran, Iran.'}]",Journal of pharmacopuncture,['10.3831/KPI.2020.23.3.173']
1678,33072714,"The Urban Built Environment, Walking and Mental Health Outcomes Among Older Adults: A Pilot Study.","The benefits of walking in older age include improved cognitive health (e.g., mental alertness, improved memory functioning) and a reduced risk of stress, depression and dementia. However, research capturing the benefits of walking among older people in real-time as they navigate their world is currently very limited. This study explores cognitive health and well-being outcomes in older people as they walk in their local neighborhood environment. Residents from an independent living facility for older people (mean age 65,  n  = 11) walked from their home in two dichotomous settings, selected on the basis of significantly different infrastructure, varying levels of noise, traffic and percentage of green space. Employing a repeated-measures, cross over design, participants were randomly allocated to one of two groups, and walked on different days in an urban busy ""gray"" district (a busy, built up commercial street) vs. an urban quiet ""green"" district (a quiet residential area with front gardens and street trees). Our study captured real-time air quality and noise data using hand-held Airbeam sensors and physiologic health data using a smart watch to capture heart rate variability (a biomarker of stress). Cognitive health outcome measures were a pre- and post-walk short cognitive reaction time (SRT) test and memory recall of the route walked (captured via a drawn mental map). Emotional well-being outcomes were a pre- and post-walk mood scale capturing perceived stress, happiness and arousal levels. Findings showed significant positive health benefits from walking in the urban green district on emotional well-being (happiness levels) and stress physiology ( p  < 0.05), accompanied by faster cognitive reaction times post-walk, albeit not statistically significant in this small sample. Cognitive recall of the route varied between urban gray and urban green conditions, as participants were more likely to rely on natural features to define their routes when present. The environmental and physiologic data sets were converged to show a significant effect of ambient noise and urban conditions on stress activation as measured by heart rate variability. Findings are discussed in relation to the complexity of combining real-time environmental and physiologic data and the implications for follow-on studies. Overall, our study demonstrates the viability of using older people as citizen scientists in the capture of environmental and physiologic stress data and establishes a new protocol for exploring relationships between the built environment and cognitive health in older people.",2020,"Findings showed significant positive health benefits from walking in the urban green district on emotional well-being (happiness levels) and stress physiology ( p  < 0.05), accompanied by faster cognitive reaction times post-walk, albeit not statistically significant in this small sample.","['Residents from an independent living facility for older people (mean age 65,  n  = 11) walked from their home in two dichotomous settings, selected on the basis of significantly different infrastructure, varying levels of noise, traffic and percentage of green space', 'Older Adults', 'older people', 'older people as they walk in their local neighborhood environment']","['urban busy ""gray"" district (a busy, built up commercial street) vs. an urban quiet ""green"" district (a quiet residential area with front gardens and street trees']","['risk of stress, depression and dementia', 'cognitive health (e.g., mental alertness, improved memory functioning', 'emotional well-being (happiness levels) and stress physiology', 'stress activation', 'Cognitive recall', 'pre- and post-walk short cognitive reaction time (SRT) test and memory recall of the route walked (captured via a drawn mental map', 'stress, happiness and arousal levels']","[{'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0021189', 'cui_str': 'Independent Living'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0014406', 'cui_str': 'Environment'}]","[{'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0556636', 'cui_str': 'Gy'}, {'cui': 'C0442658', 'cui_str': 'Street'}, {'cui': 'C0439654', 'cui_str': 'Quiet'}, {'cui': 'C0332583', 'cui_str': 'Green color'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0868963', 'cui_str': 'Gardening'}, {'cui': 'C0040811', 'cui_str': 'Tree'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0549164', 'cui_str': 'Mental alertness'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0031842', 'cui_str': 'Physiology'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0679063', 'cui_str': 'Memory recall'}, {'cui': 'C0013153', 'cui_str': 'Route of administration'}, {'cui': 'C0013113', 'cui_str': 'Drawings'}, {'cui': 'C0024779', 'cui_str': 'Maps'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}]",,0.0423352,"Findings showed significant positive health benefits from walking in the urban green district on emotional well-being (happiness levels) and stress physiology ( p  < 0.05), accompanied by faster cognitive reaction times post-walk, albeit not statistically significant in this small sample.","[{'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Roe', 'Affiliation': 'Center for Design & Health, School of Architecture, University of Virginia, Charlottesville, VA, United States.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Mondschein', 'Affiliation': 'Department of Urban and Environmental Planning, School of Architecture, University of Virginia, Charlottesville, VA, United States.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Neale', 'Affiliation': 'Center for Design & Health, School of Architecture, University of Virginia, Charlottesville, VA, United States.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Barnes', 'Affiliation': 'Engineering Systems and Environment Department, School of Engineering, University of Virginia, Charlottesville, VA, United States.'}, {'ForeName': 'Medhi', 'Initials': 'M', 'LastName': 'Boukhechba', 'Affiliation': 'Engineering Systems and Environment Department, School of Engineering, University of Virginia, Charlottesville, VA, United States.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Lopez', 'Affiliation': 'Department of Urban and Environmental Planning, School of Architecture, University of Virginia, Charlottesville, VA, United States.'}]",Frontiers in public health,['10.3389/fpubh.2020.575946']
1679,33072795,"Sodium Ingestion Improves Groundstroke Performance in Nationally-Ranked Tennis Players: A Randomized, Placebo-Controlled Crossover Trial.","This study examined the dose-response effects of ingesting different sodium concentrations on markers of hydration and tennis skill. Twelve British nationally-ranked tennis players (age: 21.5 ± 3.1 years; VO 2peak : 45.5 ± 4.4 ml . kg . min -1 ) completed four identical in-door tennis training sessions in a cluster randomized, single-blind, placebo-controlled, crossover design. Twenty-minutes prior to each training session, participants consumed a 250 ml sodium-containing beverage (10, 20, 50 mmol/L) or a placebo (0 mmol/L), and continued to consume 1,000 ml of the same beverage at set periods during the 1-h training session. Tennis groundstroke and serve performance, agility, urine osmolality, fluid loss, sodium sweat loss and perceptual responses (rating of perceived exertion (RPE), thirst, and gastrointestinal (GI) discomfort) were assessed. Results showed that ingesting 50 mmol/L sodium reduced urine osmolality (-119 mOsmol/kg;  p  = 0.037) and improved groundstroke performance (5.4;  p  < 0.001) compared with placebo. This was associated with a reduction in RPE (-0.42;  p  = 0.029), perception of thirst (-0.58;  p  = 0.012), and GI discomfort (-0.55;  p  = 0.019) during the 50 mmol/L trial compared with placebo. Linear trend analysis showed that ingesting greater concentrations of sodium proportionately reduced urine osmolality (β = -147 mOsmol/kg;  p  = 0.007) and improved groundstroke performance (β = 5.6;  p  < 0.001) in a dose response manner. Perceived thirst also decreased linearly as sodium concentration increased (β = -0.51;  p  = 0.044). There was no evidence for an effect of sodium consumption on fluid loss, sweat sodium loss, serve or agility performance ( p  > 0.05). In conclusion, consuming 50 mmol/L of sodium before and during a 1-h tennis training session reduced urine osmolality and improved groundstroke performance in nationally-ranked tennis players. There was also evidence of dose response effects, showing that ingesting greater sodium concentrations resulted in greater improvements in groundstroke performance. The enhancement in tennis skill may have resulted from an attenuation of symptomologic distracters associated with hypohydration, such as RPE, thirst and GI discomfort.",2020,"There was no evidence for an effect of sodium consumption on fluid loss, sweat sodium loss, serve or agility performance ( p  > 0.05).","['Twelve British nationally-ranked tennis players (age: 21.5 ± 3.1 years; VO 2peak : 45.5 ± 4.4 ml ', 'Nationally-Ranked Tennis Players']","['placebo', 'Placebo', 'Sodium Ingestion']","['Groundstroke Performance', 'fluid loss, sweat sodium loss, serve or agility performance', 'urine osmolality', 'urine osmolality and improved groundstroke performance', 'groundstroke performance', 'Tennis groundstroke and serve performance, agility, urine osmolality, fluid loss, sodium sweat loss and perceptual responses (rating of perceived exertion (RPE), thirst, and gastrointestinal (GI) discomfort', 'GI discomfort', 'markers of hydration and tennis skill', 'sodium concentration', 'RPE']","[{'cui': 'C0667477', 'cui_str': 'TNFRSF11A protein, human'}, {'cui': 'C0039515', 'cui_str': 'Tennis'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517683', 'cui_str': '3.1'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517761', 'cui_str': '4.4'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}]","[{'cui': 'C0235395', 'cui_str': 'Fluid loss'}, {'cui': 'C0428292', 'cui_str': 'Sweat sodium measurement'}, {'cui': 'C0740085', 'cui_str': 'Osmolality measurement, urine'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0039515', 'cui_str': 'Tennis'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0039971', 'cui_str': 'Thirst'}, {'cui': 'C1096250', 'cui_str': 'Gastrointestinal discomfort'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1321013', 'cui_str': 'Hydration status'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0035322', 'cui_str': 'Structure of retinal pigment epithelium'}]",,0.27929,"There was no evidence for an effect of sodium consumption on fluid loss, sweat sodium loss, serve or agility performance ( p  > 0.05).","[{'ForeName': 'Edward H', 'Initials': 'EH', 'LastName': 'Munson', 'Affiliation': 'Department of Sport, Health and Exercise Science, Faculty of Health Sciences, University of Hull, Hull, United Kingdom.'}, {'ForeName': 'Samuel T', 'Initials': 'ST', 'LastName': 'Orange', 'Affiliation': 'School of Biomedical, Nutritional, and Sport Sciences, Faculty of Medical Sciences, The Medical School, Newcastle University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Bray', 'Affiliation': 'Department of Sport, Health and Exercise Science, Faculty of Health Sciences, University of Hull, Hull, United Kingdom.'}, {'ForeName': 'Shane', 'Initials': 'S', 'LastName': 'Thurlow', 'Affiliation': 'Institute for Sport, Physical Activity and Leisure, Leeds Beckett University, Leeds, United Kingdom.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Marshall', 'Affiliation': 'Department of Sport, Health and Exercise Science, Faculty of Health Sciences, University of Hull, Hull, United Kingdom.'}, {'ForeName': 'Rebecca V', 'Initials': 'RV', 'LastName': 'Vince', 'Affiliation': 'Department of Sport, Health and Exercise Science, Faculty of Health Sciences, University of Hull, Hull, United Kingdom.'}]",Frontiers in nutrition,['10.3389/fnut.2020.549413']
1680,33072798,"Prevalence of Underweight, Overweight, and Obesity in Adults in Bhaktapur, Nepal in 2015-2017.","Introduction:  There is an increase in the double burden of malnutrition globally, with a particular rise documented in Asia. In Nepal, undernutrition has been prevalent for decades. Today, however, the incidence of overweight and obesity (OWOB) in the country has increased substantially. There is a need to conduct local studies reporting on the concurrent burden of both underweight and OWOB across adult populations. This study addresses this need by describing the distribution of body mass index (BMI) in a defined population of adults living in the peri-urban community of Bhaktapur, Nepal.  Material and methods:  For this cross-sectional analysis, we used data that were available from 600 women and 445 men whose children were enrolled in an individually randomized, double-blind, placebo-controlled trial assessing the effect of daily vitamin B12 supplementation. Upon enrolment of their 6-11-month old children, mothers and fathers were interviewed about their socio-demographic details. In addition, their weight and height were measured by trained field workers. Each parent's BMI was calculated as the ratio of body weight (in kg) and height squared (in m), expressed as kg/m 2 , and categorized according to the WHO recommendation. We used linear and multinomial logistic regression models to assess associations between the BMI of the mothers and fathers, and their baseline characteristics.  Results:  The mean BMI was 23.7 kg/m 2  for both the mothers and fathers with a standard deviation (SD) of 3.6 and 3.7, respectively. The proportion categorized as underweight, overweight, and obese was also similar in the two groups with around 5% being underweight, 30% being overweight and 5% being obese. Age was positively associated with BMI in both groups. Those categorized as daily wage earner had a lower mean BMI than those in other occupational groups.  Conclusion:  Our results contribute to documenting the burden of both under- and overnutrition in a selected group of young adults living in a peri-urban community in Nepal. As Nepal is undergoing an improvement in its economic situation, as well as a nutrition transition, it is important to provide sufficient information to enable timely action, and evidence-based decision-making to prevent a further increase in Nepal's growing double burden of malnutrition.",2020,Age was positively associated with BMI in both groups.,"['600 women and 445 men whose children', 'Prevalence of Underweight, Overweight, and Obesity in Adults in Bhaktapur, Nepal in 2015-2017', 'adults living in the peri-urban community of Bhaktapur, Nepal', 'young adults living in a peri-urban community in Nepal']","['vitamin B12 supplementation', 'placebo']","['ratio of body weight', 'overweight and obesity (OWOB', 'mean BMI']","[{'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0041667', 'cui_str': 'Underweight'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0027689', 'cui_str': 'Nepal'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C4524262', 'cui_str': 'Vitamin B12 supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",600.0,0.106921,Age was positively associated with BMI in both groups.,"[{'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Schwinger', 'Affiliation': 'Department of Global Public Health and Primary Care, Centre for Intervention Science in Maternal and Child Health, Centre for International Health, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Ram K', 'Initials': 'RK', 'LastName': 'Chandyo', 'Affiliation': 'Department of Community Medicine, Kathmandu Medical College, Kathmandu, Nepal.'}, {'ForeName': 'Manjeswori', 'Initials': 'M', 'LastName': 'Ulak', 'Affiliation': 'Department of Global Public Health and Primary Care, Centre for Intervention Science in Maternal and Child Health, Centre for International Health, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Hysing', 'Affiliation': 'Department of Psychosocial Science, Faculty of Psychology, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Merina', 'Initials': 'M', 'LastName': 'Shrestha', 'Affiliation': 'Department of Community Medicine, Kathmandu Medical College, Kathmandu, Nepal.'}, {'ForeName': 'Suman', 'Initials': 'S', 'LastName': 'Ranjitkar', 'Affiliation': 'Department of Community Medicine, Kathmandu Medical College, Kathmandu, Nepal.'}, {'ForeName': 'Tor A', 'Initials': 'TA', 'LastName': 'Strand', 'Affiliation': 'Department of Global Public Health and Primary Care, Centre for Intervention Science in Maternal and Child Health, Centre for International Health, University of Bergen, Bergen, Norway.'}]",Frontiers in nutrition,['10.3389/fnut.2020.567164']
1681,33072799,BMI Is Associated With Increased Plasma and Urine Appearance of Glucosinolate Metabolites After Consumption of Cooked Broccoli.,"Introduction:  Preclinical studies suggest that brassica vegetable diets decrease cancer risk, but epidemiological studies show varied effects, resulting in uncertainty about any health impact of brassicas. Factors controlling absorption of glucosinolate metabolites may relate to inconsistent results. We reported previously that subjects with BMI > 26 kg/m 2  (HiBMI), given cooked broccoli plus raw daikon radish (as a source of plant myrosinase) daily for 17 days, had lower glucosinolate metabolite absorption than subjects given a single broccoli meal. This difference was not seen in subjects with BMI < 26 kg/m 2  (LoBMI). Our objective in this current study was to determine whether a similar response occurred when cooked broccoli was consumed without a source of plant myrosinase.  Methods:  In a randomized crossover study ( n  = 18), subjects consumed no broccoli for 16 days or the same diet with 200 g of cooked broccoli daily for 15 days and 100 g of broccoli on day 16. On day 17, all subjects consumed 200 g of cooked broccoli. Plasma and urine were collected for 24 h and analyzed for glucosinolate metabolites by LC-MS.  Results:  There was no effect of diet alone or interaction of diet with BMI. However, absorption doubled in HiBMI subjects (AUC 219%, plasma mass of metabolites 202% compared to values for LoBMI subjects) and time to peak plasma metabolite values and 24-h urinary metabolites also increased, to 127 and 177% of LoBMI values, respectively.  Conclusion:  BMI impacts absorption and metabolism of glucosinolates from cooked broccoli, and this association must be further elucidated for more efficacious dietary recommendations.  Clinical Trial Registration:  This trial was registered at clinicaltrials.gov (NCT03013465).",2020,This difference was not seen in subjects with BMI < 26 kg/m 2  (LoBMI).,"['subjects with BMI > 26 kg/m 2  (HiBMI), given']","['subjects consumed no broccoli for 16 days or the same diet with 200 g of cooked broccoli daily for 15 days and 100 g of broccoli', 'single broccoli meal', 'Cooked Broccoli', 'brassica vegetable diets', 'cooked broccoli', 'cooked broccoli plus raw daikon radish']","['Plasma and Urine Appearance of Glucosinolate Metabolites', 'glucosinolate metabolite absorption', 'Plasma and urine', 'peak plasma metabolite values and 24-h urinary metabolites']","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1947971', 'cui_str': 'Give'}]","[{'cui': 'C0330498', 'cui_str': 'Brassica oleracea'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0453113', 'cui_str': 'Brassica vegetable'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0001884', 'cui_str': 'Airway Resistance'}, {'cui': 'C3486747', 'cui_str': 'Raphanus sativa extract'}, {'cui': 'C0330515', 'cui_str': 'Raphanus'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0578511', 'cui_str': 'Urine appearance'}, {'cui': 'C0017767', 'cui_str': 'Glucosinolate'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.0788997,This difference was not seen in subjects with BMI < 26 kg/m 2  (LoBMI).,"[{'ForeName': 'Craig S', 'Initials': 'CS', 'LastName': 'Charron', 'Affiliation': 'US Department of Agriculture, Agricultural Research Service, Beltsville Human Nutrition Research Center, Beltsville, MD, United States.'}, {'ForeName': 'Bryan T', 'Initials': 'BT', 'LastName': 'Vinyard', 'Affiliation': 'Statistics Group, US Department of Agriculture, Agricultural Research Service, Beltsville, MD, United States.'}, {'ForeName': 'Elizabeth H', 'Initials': 'EH', 'LastName': 'Jeffery', 'Affiliation': 'Department of Food Science and Human Nutrition, University of Illinois, Urbana, IL, United States.'}, {'ForeName': 'Sharon A', 'Initials': 'SA', 'LastName': 'Ross', 'Affiliation': 'Division of Cancer Protection, National Institutes of Health, National Cancer Institute, Rockville, MD, United States.'}, {'ForeName': 'Harold E', 'Initials': 'HE', 'LastName': 'Seifried', 'Affiliation': 'Division of Cancer Protection, National Institutes of Health, National Cancer Institute, Rockville, MD, United States.'}, {'ForeName': 'Janet A', 'Initials': 'JA', 'LastName': 'Novotny', 'Affiliation': 'US Department of Agriculture, Agricultural Research Service, Beltsville Human Nutrition Research Center, Beltsville, MD, United States.'}]",Frontiers in nutrition,['10.3389/fnut.2020.575092']
1682,33072814,Prolonged Low-Dose Methylprednisolone in Patients With Severe COVID-19 Pneumonia.,"Background


In hospitalized patients with coronavirus disease 2019 (COVID-19) pneumonia, progression to acute respiratory failure requiring invasive mechanical ventilation (MV) is associated with significant morbidity and mortality. Severe dysregulated systemic inflammation is the putative mechanism. We hypothesize that early prolonged methylprednisolone (MP) treatment could accelerate disease resolution, decreasing the need for intensive care unit (ICU) admission and mortality.
Methods


We conducted a multicenter observational study to explore the association between exposure to prolonged, low-dose MP treatment and need for ICU referral, intubation, or death within 28 days (composite primary end point) in patients with severe COVID-19 pneumonia admitted to Italian respiratory high-dependency units. Secondary outcomes were invasive MV-free days and changes in C-reactive protein (CRP) levels.
Results


Findings are reported as MP (n = 83) vs control (n = 90). The composite primary end point was met by 19 vs 40 (adjusted hazard ratio [aHR], 0.41; 95% CI, 0.24-0.72). Transfer to ICU and invasive MV were necessary in 15 vs 27 ( P  = .07) and 14 vs 26 ( P  = .10), respectively. By day 28, the MP group had fewer deaths (6 vs 21; aHR, 0.29; 95% CI, 0.12-0.73) and more days off invasive MV (24.0 ± 9.0 vs 17.5 ± 12.8;  P  = .001). Study treatment was associated with rapid improvement in PaO 2 :FiO 2  and CRP levels. The complication rate was similar for the 2 groups ( P  = .84).
Conclusion


In patients with severe COVID-19 pneumonia, early administration of prolonged MP treatment was associated with a significantly lower hazard of death (71%) and decreased ventilator dependence. Treatment was safe and did not impact viral clearance. A large randomized controlled trial (RECOVERY trial) has been performed that validates these findings.  Clinical trial registration.  ClinicalTrials.gov NCT04323592.",2020,"Transfer to ICU and invasive MV were necessary in 15 vs 27 ( P  = .07) and 14 vs 26 ( P  = .10), respectively.","['Patients With Severe COVID-19 Pneumonia', 'patients with severe COVID-19 pneumonia admitted to Italian respiratory high-dependency units', 'hospitalized patients with coronavirus disease 2019']","['methylprednisolone (MP', 'invasive mechanical ventilation (MV', 'Prolonged Low-Dose Methylprednisolone']","['days off invasive MV', 'deaths', 'hazard of death', 'Transfer to ICU and invasive MV', 'invasive MV-free days and changes in C-reactive protein (CRP) levels', 'complication rate', 'ventilator dependence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0022275', 'cui_str': 'Italian language'}, {'cui': 'C1627345', 'cui_str': 'Stepdown unit'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}]","[{'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0011546', 'cui_str': 'Dependency, Psychology'}]",,0.439876,"Transfer to ICU and invasive MV were necessary in 15 vs 27 ( P  = .07) and 14 vs 26 ( P  = .10), respectively.","[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Salton', 'Affiliation': 'Department of Pulmonology, University Hospital of Cattinara, Trieste, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Confalonieri', 'Affiliation': 'Department of Pulmonology, University Hospital of Cattinara, Trieste, Italy.'}, {'ForeName': 'G Umberto', 'Initials': 'GU', 'LastName': 'Meduri', 'Affiliation': 'Pulmonary, Critical Care, and Sleep Medicine Service and Research Service, Memphis VA Medical Center and Department of Medicine, University of Tennessee Health Science Center, Memphis, Tennessee, USA.'}, {'ForeName': 'Pierachille', 'Initials': 'P', 'LastName': 'Santus', 'Affiliation': 'Department of Biomedical and Clinical Sciences (DIBIC), Università degli Studi di Milano, ""L. Sacco"" University Hospital, ASST-Fatebenefratelli-Sacco, Milano, Italy.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Harari', 'Affiliation': 'Department of Medical Sciences, San Giuseppe Hospital MultiMedica IRCCS, and Department of Clinical Sciences and Community Health, Università degli Studi di Milano, Milan, Italy.'}, {'ForeName': 'Raffaele', 'Initials': 'R', 'LastName': 'Scala', 'Affiliation': 'Pulmonology and Respiratory Intensive Care Unit, S. Donato Hospital, Arezzo, Italy.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Lanini', 'Affiliation': 'National Institute for the Infectious Diseases ""L. Spallanzani,"" Rome, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Vertui', 'Affiliation': 'Pulmonology Unit, Policlinico San Matteo IRCCS, Pavia, Italy.'}, {'ForeName': 'Tiberio', 'Initials': 'T', 'LastName': 'Oggionni', 'Affiliation': 'Pulmonology Unit, Policlinico San Matteo IRCCS, Pavia, Italy.'}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Caminati', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, San Giuseppe Hospital MultiMedica IRCCS, Milan, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Patruno', 'Affiliation': 'Pulmonology Department, S. Maria della Misericordia University Hospital, Udine, Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Tamburrini', 'Affiliation': 'S.C. Pneumologia, Azienda Ospedaliera Friuli Occidentale, Pordenone, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Scartabellati', 'Affiliation': 'Department of Pulmonology and Respiratory High-Dependency Unit, Ospedale Maggiore, Crema, Italy.'}, {'ForeName': 'Mara', 'Initials': 'M', 'LastName': 'Parati', 'Affiliation': 'Department of Pulmonology and Respiratory High-Dependency Unit, Ospedale Maggiore, Crema, Italy.'}, {'ForeName': 'Massimiliano', 'Initials': 'M', 'LastName': 'Villani', 'Affiliation': 'Department of Pulmonology and Respiratory High-Dependency Unit, Ospedale Maggiore, Crema, Italy.'}, {'ForeName': 'Dejan', 'Initials': 'D', 'LastName': 'Radovanovic', 'Affiliation': 'Department of Biomedical and Clinical Sciences (DIBIC), Università degli Studi di Milano, ""L. Sacco"" University Hospital, ASST-Fatebenefratelli-Sacco, Milano, Italy.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Tomassetti', 'Affiliation': 'Department of Experimental and Clinical Medicine, Careggi University Hospital, Florence, Italy.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Ravaglia', 'Affiliation': 'Department of Respiratory and Thorax Diseases, GB Morgagni Hospital, Forlì, Italy.'}, {'ForeName': 'Venerino', 'Initials': 'V', 'LastName': 'Poletti', 'Affiliation': 'Department of Respiratory and Thorax Diseases, GB Morgagni Hospital, Forlì, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Vianello', 'Affiliation': 'Division of Respiratory Pathophysiology and Intensive Care, University-City Hospital, Padova, Italy.'}, {'ForeName': 'Anna Talia', 'Initials': 'AT', 'LastName': 'Gaccione', 'Affiliation': 'Pulmonology Department, Vittorio Veneto Hospital, Vittorio Veneto, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Guidelli', 'Affiliation': 'Pulmonology and Respiratory Intensive Care Unit, S. Donato Hospital, Arezzo, Italy.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Raccanelli', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, San Giuseppe Hospital MultiMedica IRCCS, Milan, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Lucernoni', 'Affiliation': 'Pulmonology Department, Vittorio Veneto Hospital, Vittorio Veneto, Italy.'}, {'ForeName': 'Donato', 'Initials': 'D', 'LastName': 'Lacedonia', 'Affiliation': 'Department of Medical and Surgical Science-University of Foggia, Policlinico Riuniti, Italy.'}, {'ForeName': 'Maria Pia', 'Initials': 'MP', 'LastName': 'Foschino Barbaro', 'Affiliation': 'Department of Medical and Surgical Science-University of Foggia, Policlinico Riuniti, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Centanni', 'Affiliation': 'Pulmonology Department, S. Paolo Hospital, Milan, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Mondoni', 'Affiliation': 'Pulmonology Department, S. Paolo Hospital, Milan, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Davì', 'Affiliation': 'Pulmonology Department, S. Paolo Hospital, Milan, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Fantin', 'Affiliation': 'Pulmonology Department, S. Maria della Misericordia University Hospital, Udine, Italy.'}, {'ForeName': 'Xueyuan', 'Initials': 'X', 'LastName': 'Cao', 'Affiliation': 'Department of Acute and Tertiary Care, College of Nursing, University of Tennessee Health Science Center, Memphis, Tennessee, USA.'}, {'ForeName': 'Lucio', 'Initials': 'L', 'LastName': 'Torelli', 'Affiliation': 'Department of Clinical, Surgery and Health Sciences, University of Trieste, Trieste, Italy.'}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Zucchetto', 'Affiliation': 'Scientific Directorate, Centro di Riferimento Oncologico di Aviano (CRO) IRCCS, Aviano, Italy.'}, {'ForeName': 'Marcella', 'Initials': 'M', 'LastName': 'Montico', 'Affiliation': 'Scientific Directorate, Centro di Riferimento Oncologico di Aviano (CRO) IRCCS, Aviano, Italy.'}, {'ForeName': 'Annalisa', 'Initials': 'A', 'LastName': 'Casarin', 'Affiliation': 'Centre for Health Services and Clinical Research, University of Hertfordshire, Hatfield, UK.'}, {'ForeName': 'Micaela', 'Initials': 'M', 'LastName': 'Romagnoli', 'Affiliation': 'Pulmonary Unit, Treviso Hospital, Treviso, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Gasparini', 'Affiliation': 'Department of Biomedical Sciences and Public Health, Polytechnic University of Marche Region-Azienda Ospedali Riuniti, Ancona, Italy.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Bonifazi', 'Affiliation': 'Department of Biomedical Sciences and Public Health, Polytechnic University of Marche Region-Azienda Ospedali Riuniti, Ancona, Italy.'}, {'ForeName': 'Pierlanfranco', 'Initials': 'P', 'LastName': ""D'Agaro"", 'Affiliation': 'Laboratorio di Riferimento per SARS-CoV-2, Regione Friuli-Venezia Giulia, Azienda Sanitaria Universitaria Integrata Giuliano Isontina (ASUGI), University of Trieste, Trieste, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Marcello', 'Affiliation': 'Laboratory of Molecular Virology, International Centre for Genetic Engineering and Biotechnology (ICGEB), Trieste, Italy.'}, {'ForeName': 'Danilo', 'Initials': 'D', 'LastName': 'Licastro', 'Affiliation': 'ARGO Open Lab Platform for Genome Sequencing, Area Science Park, Trieste, Italy.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Ruaro', 'Affiliation': 'Department of Pulmonology, University Hospital of Cattinara, Trieste, Italy.'}, {'ForeName': 'Maria Concetta', 'Initials': 'MC', 'LastName': 'Volpe', 'Affiliation': 'University of Trieste, Trieste, Italy.'}, {'ForeName': 'Reba', 'Initials': 'R', 'LastName': 'Umberger', 'Affiliation': 'Department of Acute and Tertiary Care, College of Nursing, University of Tennessee Health Science Center, Memphis, Tennessee, USA.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Confalonieri', 'Affiliation': 'Department of Pulmonology, University Hospital of Cattinara, Trieste, Italy.'}]",Open forum infectious diseases,['10.1093/ofid/ofaa421']
1683,33072852,Mediators of Effects of Cooperative Learning on Prosocial Behavior in Middle School.,"In this study, we tested the effects of cooperative learning on students' prosocial behavior. Cooperative learning is a small-group instructional technique that establishes positive interdependence among students and, unlike most current school-based programs, does not mandate a formal curriculum. Given the emphasis in cooperative learning on peer reinforcement for positive and helpful behavior during learning activities, we hypothesized that cooperative learning would promote higher levels of prosocial behavior, and that these effects would be mediated by peer relatedness. Using a sample of 1,890 students (47.1% female, 75.2% White) from a cluster randomized trial of 15 middle schools, we found that cooperative learning significantly enhanced prosocial behavior across two years. Mediation was only partial, however, suggesting that additional mechanisms were at work, such as changes to social norms or teacher behavior. Given that cooperative learning has been shown to enhance student engagement and academic achievement in prior research, we argue that cooperative learning should be a central component of teacher training and professional development.",2020,"Mediation was only partial, however, suggesting that additional mechanisms were at work, such as changes to social norms or teacher behavior.","['1,890 students (47.1% female, 75.2% White) from a cluster randomized trial of 15 middle schools', 'Prosocial Behavior in Middle School', ""students' prosocial behavior""]","['Cooperative learning', 'cooperative learning', 'Cooperative Learning']",['prosocial behavior'],"[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0557797', 'cui_str': 'Middle school'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",15.0,0.0405536,"Mediation was only partial, however, suggesting that additional mechanisms were at work, such as changes to social norms or teacher behavior.","[{'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Van Ryzin', 'Affiliation': 'Oregon Research Institute, Eugene, OR.'}, {'ForeName': 'Cary J', 'Initials': 'CJ', 'LastName': 'Roseth', 'Affiliation': 'Michigan State University, East Lansing, MI.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Biglan', 'Affiliation': 'Oregon Research Institute, Eugene, OR.'}]",International journal of applied positive psychology,['10.1007/s41042-020-00026-8']
1684,33072884,Protocol: The Lacunar Intervention Trial 2 (LACI-2). A trial of two repurposed licenced drugs to prevent progression of cerebral small vessel disease.,"Background


Small vessel disease causes a quarter of ischaemic strokes (lacunar subtype), up to 45% of dementia either as vascular or mixed types, cognitive impairment and physical frailty. However, there is no specific treatment to prevent progression of small vessel disease.
Aim


We designed the LACunar Intervention Trial-2 (LACI-2) to test feasibility of a large trial testing cilostazol and/or isosorbide mononitrate (ISMN) by demonstrating adequate participant recruitment and retention in follow-up, drug tolerability, safety and confirm outcome event rates required to power a phase 3 trial.
Methods and design


LACI-2 is an investigator-initiated, prospective randomised open label blinded endpoint (PROBE) trial aiming to recruit 400 patients with prior lacunar syndrome due to a small subcortical infarct. We randomise participants to cilostazol v no cilostazol and ISMN or no ISMN, minimising on key prognostic factors. All patients receive guideline-based best medical therapy. Patients commence trial drug at low dose, increment to full dose over 2-4 weeks, continuing on full dose for a year. We follow-up participants to one year for symptoms, tablet compliance, safety, recurrent vascular events, cognition and functional outcomes, Trails B and brain MRI. LACI-2 is registered ISRCTN 14911850, EudraCT 2016-002277-35. Trial outcome:  Primary outcome is feasibility of recruitment and compliance; secondary outcomes include safety (cerebral or systemic bleeding, falls, death), efficacy (recurrent cerebral and cardiac vascular events, cognition on TICS, Trails B) and tolerability.
Summary


LACI-2 will determine feasibility, tolerability and provide outcome rates to power a large phase 3 trial to prevent progression of cerebral small vessel disease.",2020,"Primary outcome is feasibility of recruitment and compliance; secondary outcomes include safety (cerebral or systemic bleeding, falls, death), efficacy (recurrent cerebral and cardiac vascular events, cognition on TICS, Trails B) and tolerability.
",['400 patients with prior lacunar syndrome due to a small subcortical infarct'],"['cilostazol and/or isosorbide mononitrate (ISMN', 'guideline-based best medical therapy', 'Protocol', 'LACunar Intervention Trial-2 (LACI-2', 'cilostazol v no cilostazol and ISMN or no ISMN']","['symptoms, tablet compliance, safety, recurrent vascular events, cognition and functional outcomes, Trails B and brain MRI', 'progression of cerebral small vessel disease', 'feasibility of recruitment and compliance; secondary outcomes include safety (cerebral or systemic bleeding, falls, death), efficacy (recurrent cerebral and cardiac vascular events, cognition on TICS, Trails B) and tolerability']","[{'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C3178801', 'cui_str': 'Lacunar stroke'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}]","[{'cui': 'C0055729', 'cui_str': 'cilostazol'}, {'cui': 'C0064079', 'cui_str': 'isosorbide mononitrate'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C4028269', 'cui_str': 'Nuclear magnetic resonance imaging brain'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C2733158', 'cui_str': 'Small vessel cerebrovascular disease'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0040188', 'cui_str': 'Tic disorder'}]",400.0,0.125337,"Primary outcome is feasibility of recruitment and compliance; secondary outcomes include safety (cerebral or systemic bleeding, falls, death), efficacy (recurrent cerebral and cardiac vascular events, cognition on TICS, Trails B) and tolerability.
","[{'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Wardlaw', 'Affiliation': 'The University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Philip M W', 'Initials': 'PMW', 'LastName': 'Bath', 'Affiliation': 'Stroke Trials Unit, Division of Clinical Neuroscience, The University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Fergus', 'Initials': 'F', 'LastName': 'Doubal', 'Affiliation': 'The University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Heye', 'Affiliation': 'The University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Nikola', 'Initials': 'N', 'LastName': 'Sprigg', 'Affiliation': 'Stroke Trials Unit, Division of Clinical Neuroscience, The University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Lisa J', 'Initials': 'LJ', 'LastName': 'Woodhouse', 'Affiliation': 'University Hospital Coventry and Warwickshire, Coventry, UK.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Blair', 'Affiliation': 'The University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Appleton', 'Affiliation': 'University of Nottingham, Derby, UK.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Cvoro', 'Affiliation': 'The University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'England', 'Affiliation': 'Leeds General Infirmary, Leeds, UK.'}, {'ForeName': 'Ahamad', 'Initials': 'A', 'LastName': 'Hassan', 'Affiliation': 'University College London Institute of Neurology, London, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'John Werring', 'Affiliation': 'University College London Institute of Neurology, London, UK.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Montgomery', 'Affiliation': 'Stroke Trials Unit, Division of Clinical Neuroscience, The University of Nottingham, Nottingham, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European stroke journal,['10.1177/2396987320920110']
1685,33079901,Influence of Femoral Component Design on Proximal Femoral Bone Mass After Total Hip Replacement: A Randomized Controlled Trial.,"BACKGROUND


In this randomized controlled trial (RCT), we compared bone remodeling and bone turnover between 2 total hip arthroplasty implants-the short, proximally porous-coated Tri-Lock Bone-Preservation Stem and a conventional, fully-coated Corail prosthesis-over a 2-year postoperative period.
METHODS


Forty-six participants received the Tri-Lock prosthesis and 40 received the Corail prosthesis. At baseline, the 2 groups had similar demographics, proximal femoral bone mineral density (BMD), bone turnover markers, radiographic canal flare index, and patient-reported outcome measure (PROM) scores. Outcomes were measured at weeks 26, 52, and 104.
RESULTS


Loss of periprosthetic bone, measured by high-sensitivity dual x-ray absorptiometry region-free analysis (DXA-RFA), was identified at the calcar and proximal-lateral aspect of the femur in both prosthesis groups (p < 0.05). However, the conventional prosthesis was associated with a smaller reduction in BMD compared with the bone-preservation prosthesis (p < 0.001). This effect was most prominent in the region of the femoral calcar and greater trochanter. A small gain in BMD was also identified in some areas, and this gain was greater with the conventional than the bone-preservation prosthesis (p < 0.001). The 2 groups had similar changes in bone turnover markers and improvement in PROM scores over the study period (p > 0.05). The adverse-event rate was also similar between the groups (p > 0.05).
CONCLUSIONS


This RCT shows that prostheses intended to preserve proximal femoral bone do not necessarily perform better in this regard than conventional cementless designs. DXA-RFA is a sensitive tool for detecting spatially complex patterns of periprosthetic bone remodeling.
LEVEL OF EVIDENCE


Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.",2020,The 2 groups had similar changes in bone turnover markers and improvement in PROM scores over the study period (p > 0.05).,"['Forty-six participants received the', 'After Total Hip Replacement']","['DXA-RFA', 'Tri-Lock prosthesis and 40 received the Corail prosthesis', 'Femoral Component Design']","['PROM scores', 'bone remodeling and bone turnover', 'Loss of periprosthetic bone', 'bone turnover markers', 'Proximal Femoral Bone Mass', 'similar demographics, proximal femoral bone mineral density (BMD), bone turnover markers, radiographic canal flare index, and patient-reported outcome measure (PROM) scores', 'adverse-event rate', 'BMD']","[{'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}]","[{'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0065404', 'cui_str': 'lysyl-5-fluorotryptophyl-lysine'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}, {'cui': 'C0449434', 'cui_str': 'Femoral component'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}]","[{'cui': 'C4277735', 'cui_str': 'Patient Reported Outcome Measures'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0086881', 'cui_str': 'Pulp canal'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.162008,The 2 groups had similar changes in bone turnover markers and improvement in PROM scores over the study period (p > 0.05).,"[{'ForeName': 'Pablo A', 'Initials': 'PA', 'LastName': 'Slullitel', 'Affiliation': 'Division of Orthopaedic Surgery, The Ottawa Hospital, Ottawa, Ontario, Canada.'}, {'ForeName': 'Mohit M', 'Initials': 'MM', 'LastName': 'Mahatma', 'Affiliation': 'Department of Oncology and Metabolism, University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Farzi', 'Affiliation': 'Centre for Computational Imaging and Simulation Technologies in Bioscience, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Grammatopoulos', 'Affiliation': 'Division of Orthopaedic Surgery, The Ottawa Hospital, Ottawa, Ontario, Canada.'}, {'ForeName': 'J Mark', 'Initials': 'JM', 'LastName': 'Wilkinson', 'Affiliation': 'Department of Oncology and Metabolism, University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'Paul E', 'Initials': 'PE', 'LastName': 'Beaulé', 'Affiliation': 'Division of Orthopaedic Surgery, The Ottawa Hospital, Ottawa, Ontario, Canada.'}]",The Journal of bone and joint surgery. American volume,['10.2106/JBJS.20.00351']
1686,33079921,Cross-Linking Assisted Infection Reduction (CLAIR): A Randomized Clinical Trial Evaluating the Effect of Adjuvant Cross-Linking on Bacterial Keratitis.,"PURPOSE


To determine whether there is a benefit to adjuvant corneal cross-linking (CXL) for bacterial keratitis.
METHODS


This is an outcome-masked, randomized controlled clinical trial. Consecutive patients presenting with a smear-positive bacterial ulcer at Aravind Eye Hospitals at Madurai, Pondicherry, and Coimbatore in India were enrolled. Study eyes were randomized to topical moxifloxacin 0.5% or topical moxifloxacin 0.5% plus CXL. The primary outcome of the trial was microbiological cure at 24 hours on repeat culture. Secondary outcomes included best spectacle corrected visual acuity at 3 weeks and 3 months, percentage of study participants with epithelial healing at 3 weeks and 3 months, infiltrate and/or scar size at 3 weeks and 3 months, 3-day smear and culture, and adverse events.
RESULTS


Those randomized to CXL had 0.60 decreased odds of culture positivity at 24 hours (95% confidence interval [CI]: 0.10-3.50; P = 0.65), 0.9 logarithm of the minimum angle of resolution lines worse visual acuity (95% CI: -2.8 to 4.6; P = 0.63), and 0.41-mm larger scar size (95% CI: -0.48 to 1.30; P = 0.38) at 3 months. We note fewer corneal perforations or need for therapeutic penetrating keratoplasty in the CXL group.
CONCLUSIONS


We were unable to confirm a benefit to adjuvant CXL in the primary treatment of moderate bacterial keratitis. However, CXL may reduce culture positivity and complication rates; therefore, a larger trial to fully evaluate this is warranted.
TRIAL REGISTRATION


NCT02570321.",2020,Those randomized to CXL had 0.60 decreased odds of culture positivity at 24 hours (95% confidence interval [CI]:,"['Consecutive patients presenting with a smear-positive bacterial ulcer at Aravind Eye Hospitals at Madurai, Pondicherry, and Coimbatore in India were enrolled']","['Adjuvant Cross-Linking on Bacterial Keratitis', 'Cross-Linking Assisted Infection Reduction (CLAIR', 'adjuvant corneal cross-linking (CXL', 'topical moxifloxacin 0.5% or topical moxifloxacin 0.5% plus CXL', 'CXL']","['spectacle corrected visual acuity at 3 weeks and 3 months, percentage of study participants with epithelial healing at 3 weeks and 3 months, infiltrate and/or scar size at 3 weeks and 3 months, 3-day smear and culture, and adverse events', 'scar size', 'microbiological cure at 24 hours on repeat culture', 'visual acuity', 'culture positivity and complication rates', 'culture positivity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0444186', 'cui_str': 'Smear test'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0021201', 'cui_str': 'India'}]","[{'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0332220', 'cui_str': 'Cross-linking'}, {'cui': 'C0854211', 'cui_str': 'Bacterial keratitis'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C4728129', 'cui_str': 'Corneal cross linking'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0536495', 'cui_str': 'moxifloxacin'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0015421', 'cui_str': 'Eyeglasses'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0444186', 'cui_str': 'Smear test'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0025953', 'cui_str': 'microbiology'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",,0.372954,Those randomized to CXL had 0.60 decreased odds of culture positivity at 24 hours (95% confidence interval [CI]:,"[{'ForeName': 'N Venkatesh', 'Initials': 'NV', 'LastName': 'Prajna', 'Affiliation': 'Aravind Eye Hospitals, Madurai, Coimbatore, Pondicherry, India.'}, {'ForeName': 'Naveen', 'Initials': 'N', 'LastName': 'Radhakrishnan', 'Affiliation': 'Aravind Eye Hospitals, Madurai, Coimbatore, Pondicherry, India.'}, {'ForeName': 'Prajna', 'Initials': 'P', 'LastName': 'Lalitha', 'Affiliation': 'Aravind Eye Hospitals, Madurai, Coimbatore, Pondicherry, India.'}, {'ForeName': 'Revathi', 'Initials': 'R', 'LastName': 'Rajaraman', 'Affiliation': 'Aravind Eye Hospitals, Madurai, Coimbatore, Pondicherry, India.'}, {'ForeName': 'Shivananda', 'Initials': 'S', 'LastName': 'Narayana', 'Affiliation': 'Aravind Eye Hospitals, Madurai, Coimbatore, Pondicherry, India.'}, {'ForeName': 'Ariana F', 'Initials': 'AF', 'LastName': 'Austin', 'Affiliation': 'Francis I. Proctor Foundation, University of California San Francisco, CA.'}, {'ForeName': 'Zijun', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Francis I. Proctor Foundation, University of California San Francisco, CA.'}, {'ForeName': 'Jeremy D', 'Initials': 'JD', 'LastName': 'Keenan', 'Affiliation': 'Francis I. Proctor Foundation, University of California San Francisco, CA.'}, {'ForeName': 'Travis C', 'Initials': 'TC', 'LastName': 'Porco', 'Affiliation': 'Francis I. Proctor Foundation, University of California San Francisco, CA.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Lietman', 'Affiliation': 'Francis I. Proctor Foundation, University of California San Francisco, CA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Rose-Nussbaumer', 'Affiliation': 'Francis I. Proctor Foundation, University of California San Francisco, CA.'}]",Cornea,['10.1097/ICO.0000000000002510']
1687,33079935,Randomized nutrient bar supplementation improves exercise-associated changes in plasma metabolome in adolescents and adult family members at cardiometabolic risk.,"BACKGROUND


Poor diets contribute to metabolic complications of obesity, insulin resistance and dyslipidemia. Metabolomic biomarkers may serve as early nutrition-sensitive health indicators. This family-based lifestyle change program compared metabolic outcomes in an intervention group (INT) that consumed 2 nutrient bars daily for 2-months and a control group (CONT).
METHODS


Overweight, predominantly minority and female adolescent (Teen)/parent adult caretaker (PAC) family units were recruited from a pediatric obesity clinic. CONT (8 Teen, 8 PAC) and INT (10 Teen, 10 PAC) groups randomized to nutrient bar supplementation attended weekly classes that included group nutrition counseling and supervised exercise. Pre-post physical and behavioral parameters, fasting traditional biomarkers, plasma sphingolipids and amino acid metabolites were measured.
RESULTS


In the full cohort, a baseline sphingolipid ceramide principal component composite score correlated with adiponectin, triglycerides, triglyceride-rich very low density lipoproteins, and atherogenic small low density lipoprotein (LDL) sublasses. Inverse associations were seen between a sphingomyelin composite score and C-reactive protein, a dihydroceramide composite score and diastolic blood pressure, and the final principal component that included glutathionone with fasting insulin and the homeostatic model of insulin resistance. In CONT, plasma ceramides, sphinganine, sphingosine and amino acid metabolites increased, presumably due to increased physical activity. Nutrient bar supplementation (INT) blunted this rise and significantly decreased ureagenic, aromatic and gluconeogenic amino acid metabolites. Metabolomic changes were positively correlated with improvements in clinical biomarkers of dyslipidemia.
CONCLUSION


Nutrient bar supplementation with increased physical activity in obese Teens and PAC elicits favorable metabolomic changes that correlate with improved dyslipidemia. The trial from which the analyses reported upon herein was part of a series of nutrient bar clinical trials registered at clinicaltrials.gov as NCT02239198.",2020,"Nutrient bar supplementation (INT) blunted this rise and significantly decreased ureagenic, aromatic and gluconeogenic amino acid metabolites.","['Overweight, predominantly minority and female adolescent (Teen)/parent adult caretaker (PAC) family units were recruited from a pediatric obesity clinic', 'adolescents and adult family members at cardiometabolic risk']","['Nutrient bar supplementation', 'nutrient bar supplementation attended weekly classes that included group nutrition counseling and supervised exercise', 'Nutrient bar supplementation (INT']","['Pre-post physical and behavioral parameters, fasting traditional biomarkers, plasma sphingolipids and amino acid metabolites', 'plasma ceramides, sphinganine, sphingosine and amino acid metabolites', 'sphingomyelin composite score and C-reactive protein, a dihydroceramide composite score and diastolic blood pressure', 'clinical biomarkers of dyslipidemia', 'physical activity', 'dyslipidemia', 'ureagenic, aromatic and gluconeogenic amino acid metabolites', 'adiponectin, triglycerides, triglyceride-rich very low density lipoproteins, and atherogenic small low density lipoprotein (LDL) sublasses', 'plasma metabolome']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0335350', 'cui_str': 'Building caretaker'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C2362324', 'cui_str': 'Childhood obesity'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]","[{'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0001643', 'cui_str': 'Beta-2 adrenergic receptor'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3714365', 'cui_str': 'Nutrition counseling'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4039165', 'cui_str': 'Increased physical activity'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0037900', 'cui_str': 'Sphingolipid'}, {'cui': 'C0002520', 'cui_str': 'amino acids'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0007745', 'cui_str': 'Ceramides'}, {'cui': 'C0074987', 'cui_str': 'sphinganine'}, {'cui': 'C0037907', 'cui_str': 'Sphingosine'}, {'cui': 'C0037906', 'cui_str': 'Sphingomyelin'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0668446', 'cui_str': 'dihydroceramide'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0023825', 'cui_str': 'Very low density lipoprotein'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C2350399', 'cui_str': 'Metabolome'}]",,0.038699,"Nutrient bar supplementation (INT) blunted this rise and significantly decreased ureagenic, aromatic and gluconeogenic amino acid metabolites.","[{'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Mietus-Snyder', 'Affiliation': ""Division of Cardiology, Department of Pediatrics, Children's National Hospital, George Washington University School of Medicine and Health Sciences, Washington DC, United States of America.""}, {'ForeName': 'Nisha', 'Initials': 'N', 'LastName': 'Narayanan', 'Affiliation': 'Weill Cornell Medical College, Cornell University, New York, New York, United States of America.'}, {'ForeName': 'Ronald M', 'Initials': 'RM', 'LastName': 'Krauss', 'Affiliation': ""University of California Benioff Children's Hospital San Francisco, San Francisco, California, United States of America.""}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Laine-Graves', 'Affiliation': ""University of California Benioff Children's Hospital Oakland Research Institute, Oakland, California, United States of America.""}, {'ForeName': 'Joyce C', 'Initials': 'JC', 'LastName': 'McCann', 'Affiliation': ""University of California Benioff Children's Hospital Oakland Research Institute, Oakland, California, United States of America.""}, {'ForeName': 'Mark K', 'Initials': 'MK', 'LastName': 'Shigenaga', 'Affiliation': ""University of California Benioff Children's Hospital Oakland Research Institute, Oakland, California, United States of America.""}, {'ForeName': 'Tara H', 'Initials': 'TH', 'LastName': 'McHugh', 'Affiliation': 'United States Department of Agriculture, Western Regional Research Center, Albany, California, United States of America.'}, {'ForeName': 'Bruce N', 'Initials': 'BN', 'LastName': 'Ames', 'Affiliation': ""University of California Benioff Children's Hospital Oakland Research Institute, Oakland, California, United States of America.""}, {'ForeName': 'Jung H', 'Initials': 'JH', 'LastName': 'Suh', 'Affiliation': ""University of California Benioff Children's Hospital Oakland Research Institute, Oakland, California, United States of America.""}]",PloS one,['10.1371/journal.pone.0240437']
1688,33079959,Homologous and heterologous re-challenge with Salmonella Typhi and Salmonella Paratyphi A in a randomised controlled human infection model.,"Enteric fever is a systemic infection caused by Salmonella Typhi or Paratyphi A. In many endemic areas, these serovars co-circulate and can cause multiple infection-episodes in childhood. Prior exposure is thought to confer partial, but incomplete, protection against subsequent attacks of enteric fever. Empirical data to support this hypothesis are limited, and there are few studies describing the occurrence of heterologous-protection between these closely related serovars. We performed a challenge-re-challenge study using a controlled human infection model (CHIM) to investigate the extent of infection-derived immunity to Salmonella Typhi or Paratyphi A infection. We recruited healthy volunteers into two groups: naïve volunteers with no prior exposure to Salmonella Typhi/Paratyphi A and volunteers previously-exposed to Salmonella Typhi or Paratyphi A in earlier CHIM studies. Within each group, participants were randomised 1:1 to oral challenge with either Salmonella Typhi (104 CFU) or Paratyphi A (103 CFU). The primary objective was to compare the attack rate between naïve and previously challenged individuals, defined as the proportion of participants per group meeting the diagnostic criteria of temperature of ≥38°C persisting for ≥12 hours and/or S. Typhi/Paratyphi bacteraemia up to day 14 post challenge. The attack-rate in participants who underwent homologous re-challenge with Salmonella Typhi was reduced compared with challenged naïve controls, although this reduction was not statistically significant (12/27[44%] vs. 12/19[63%]; Relative risk 0.70; 95% CI 0.41-1.21; p = 0.24). Homologous re-challenge with Salmonella Paratyphi A also resulted in a lower attack-rate than was seen in challenged naïve controls (3/12[25%] vs. 10/18[56%]; RR0.45; 95% CI 0.16-1.30; p = 0.14). Evidence of protection was supported by a post hoc analysis in which previous exposure was associated with an approximately 36% and 57% reduced risk of typhoid or paratyphoid disease respectively on re-challenge. Individuals who did not develop enteric fever on primary exposure were significantly more likely to be protected on re-challenge, compared with individuals who developed disease on primary exposure. Heterologous re-challenge with Salmonella Typhi or Salmonella Paratyphi A was not associated with a reduced attack rate following challenge. Within the context of the model, prior exposure was not associated with reduced disease severity, altered microbiological profile or boosting of humoral immune responses. We conclude that prior Salmonella Typhi and Paratyphi A exposure may confer partial but incomplete protection against subsequent infection, but with a comparable clinical and microbiological phenotype. There is no demonstrable cross-protection between these serovars, consistent with the co-circulation of Salmonella Typhi and Paratyphi A. Collectively, these data are consistent with surveillance and modelling studies that indicate multiple infections can occur in high transmission settings, supporting the need for vaccines to reduce the burden of disease in childhood and achieve disease control. Trial registration NCT02192008; clinicaltrials.gov.",2020,"The attack-rate in participants who underwent homologous re-challenge with Salmonella Typhi was reduced compared with challenged naïve controls, although this reduction was not statistically significant (12/27[44%] vs. 12/19[63%]; Relative risk 0.70; 95% CI 0.41-1.21; p = 0.24).",['healthy volunteers into two groups: naïve volunteers with no prior exposure to Salmonella Typhi/Paratyphi A and volunteers previously-exposed to Salmonella Typhi or Paratyphi A in earlier CHIM studies'],"['Salmonella Typhi (104 CFU) or Paratyphi A (103 CFU', 'Salmonella Typhi or Salmonella Paratyphi', 'Salmonella Typhi and Salmonella Paratyphi']","['lower attack-rate', 'attack rate', 'attack-rate']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C2732504', 'cui_str': 'Exposure to Salmonella'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0036125', 'cui_str': 'Salmonella Typhi'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0036125', 'cui_str': 'Salmonella Typhi'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0553561', 'cui_str': 'colony-forming unit'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0036115', 'cui_str': 'Salmonella Paratyphi C'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0004063', 'cui_str': 'Assault'}]",,0.0655881,"The attack-rate in participants who underwent homologous re-challenge with Salmonella Typhi was reduced compared with challenged naïve controls, although this reduction was not statistically significant (12/27[44%] vs. 12/19[63%]; Relative risk 0.70; 95% CI 0.41-1.21; p = 0.24).","[{'ForeName': 'Malick M', 'Initials': 'MM', 'LastName': 'Gibani', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, United Kingdom.'}, {'ForeName': 'Celina', 'Initials': 'C', 'LastName': 'Jin', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, United Kingdom.'}, {'ForeName': 'Sonu', 'Initials': 'S', 'LastName': 'Shrestha', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, United Kingdom.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Moore', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, United Kingdom.'}, {'ForeName': 'Lily', 'Initials': 'L', 'LastName': 'Norman', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, United Kingdom.'}, {'ForeName': 'Merryn', 'Initials': 'M', 'LastName': 'Voysey', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, United Kingdom.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Jones', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, United Kingdom.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Blackwell', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, United Kingdom.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Thomaides-Brears', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, United Kingdom.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Hill', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, United Kingdom.'}, {'ForeName': 'Christoph J', 'Initials': 'CJ', 'LastName': 'Blohmke', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, United Kingdom.'}, {'ForeName': 'Hazel C', 'Initials': 'HC', 'LastName': 'Dobinson', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, United Kingdom.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Baker', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, United Kingdom.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Jones', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, United Kingdom.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Campbell', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, United Kingdom.'}, {'ForeName': 'Yama F', 'Initials': 'YF', 'LastName': 'Mujadidi', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, United Kingdom.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Plested', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, United Kingdom.'}, {'ForeName': 'Lorena', 'Initials': 'L', 'LastName': 'Preciado-Llanes', 'Affiliation': 'Institute for Infection and Global Health, University of Liverpool, United Kingdom.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Napolitani', 'Affiliation': 'Medical Research Council Human Immunology Unit, Radcliffe Department of Medicine, University of Oxford, United Kingdom.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Simmons', 'Affiliation': 'Medical Research Council Human Immunology Unit, Radcliffe Department of Medicine, University of Oxford, United Kingdom.'}, {'ForeName': 'Melita A', 'Initials': 'MA', 'LastName': 'Gordon', 'Affiliation': 'Institute for Infection and Global Health, University of Liverpool, United Kingdom.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Angus', 'Affiliation': 'Nuffield Department of Medicine, University of Oxford, United Kingdom.'}, {'ForeName': 'Thomas C', 'Initials': 'TC', 'LastName': 'Darton', 'Affiliation': 'Department of Infection, Immunity and Cardiovascular Disease, University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Cerundulo', 'Affiliation': 'Medical Research Council Human Immunology Unit, Radcliffe Department of Medicine, University of Oxford, United Kingdom.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Pollard', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, United Kingdom.'}]",PLoS neglected tropical diseases,['10.1371/journal.pntd.0008783']
1689,33080034,The effects of bright light treatment on subjective and objective sleepiness during three consecutive night shifts among hospital nurses - a counter-balanced placebo-controlled crossover study.,"Objectives The objective was to investigate effects of timed bright light treatment on subjective and objective measures of sleepiness during three consecutive night shifts among hospital nurses. Methods Thirty-five nurses were exposed to bright light (10,000 lux) and red dim light (100 lux) during three consecutive night shifts in a counter-balanced crossover trial lasting nine days, which included three days before and three days after the three night shifts. Light exposure for 30 minutes was scheduled between 02:00-03:00 hours on night 1, and thereafter delayed by one hour per night in order to delay the circadian rhythm. Subjective sleepiness was measured daily (heavy eyelids, reduced performance) and every second hour while awake (Karolinska Sleepiness Scale, KSS). Objective sleepiness (Psychomotor Vigilance Task, PVT) was measured at 05:00 hours during each night shift. Beyond nocturnal light exposure on the night shifts, no behavioral restrictions or recommendations were given at or off work. Results Bright light treatment significantly reduced heavy eyelids during night shifts. However, results on KSS and PVT were unaffected by bright light. There were no differences in subjective sleepiness during the three days following the night shifts. Conclusions This bright light treatment protocol did not convincingly reduce sleepiness among nurses during three consecutive night shifts. Nor did bright light impede the readaptation back to a day-oriented rhythm following the night shift period. Too few consecutive night shifts, inappropriate timing of light, and possible use of other countermeasures are among the explanations for the limited effects of bright light in the present study.",2020,There were no differences in subjective sleepiness during the three days following the night shifts.,['sleepiness during three consecutive night shifts among hospital nurses'],"['bright light (10,000 lux) and red dim light', 'bright light treatment', 'timed bright light treatment']","['heavy eyelids', 'KSS and PVT', 'Objective sleepiness (Psychomotor Vigilance Task, PVT', 'Subjective sleepiness was measured daily (heavy eyelids, reduced performance) and every second hour while awake (Karolinska Sleepiness Scale, KSS', 'subjective sleepiness', 'subjective and objective sleepiness']","[{'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C1271036', 'cui_str': 'Hospital nurse'}]","[{'cui': 'C0423899', 'cui_str': 'Above average intellect'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0024176', 'cui_str': 'Luxembourg'}, {'cui': 'C0332575', 'cui_str': 'Red color'}, {'cui': 'C0114346', 'cui_str': 'dimesna'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0040223', 'cui_str': 'Time'}]","[{'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0015426', 'cui_str': 'Eyelid structure'}, {'cui': 'C0022541', 'cui_str': 'Kearns-Sayre syndrome'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0043012', 'cui_str': 'Wakefulness'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0585312', 'cui_str': 'Every second'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0234422', 'cui_str': 'Awake'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",35.0,0.0158712,There were no differences in subjective sleepiness during the three days following the night shifts.,"[{'ForeName': 'Bjørn', 'Initials': 'B', 'LastName': 'Bjorvatn', 'Affiliation': 'Department of Global Public Health and Primary Care, University of Bergen, Kalfarveien 31, N-5018 Bergen, Norway. bjorn.bjorvatn@uib.no.'}, {'ForeName': 'Ståle', 'Initials': 'S', 'LastName': 'Pallesen', 'Affiliation': ''}, {'ForeName': 'Siri', 'Initials': 'S', 'LastName': 'Waage', 'Affiliation': ''}, {'ForeName': 'Eirunn', 'Initials': 'E', 'LastName': 'Thun', 'Affiliation': ''}, {'ForeName': 'Kjersti M', 'Initials': 'KM', 'LastName': 'Blytt', 'Affiliation': ''}]","Scandinavian journal of work, environment & health",['10.5271/sjweh.3930']
1690,33080085,Effect of prucalopride on sildenafil-induced inhibition of esophageal peristalsis in healthy adults.,"BACKGROUND AND AIM


Prucalopride, a high-affinity 5-hydroxytryptamine 4 (5-HT 4  ) receptor agonist, promotes esophageal peristalsis, while phosphodiesterase type 5 (PDE5) inhibitor sildenafil inhibits esophageal peristalsis. The present study was aimed to evaluate whether prucalopride would augment esophageal peristalsis subsequent to the application of sildenafil.
METHODS


Seventeen healthy adults underwent high resolution manometry by a catheter with one injection port located in mid-esophagus. Secondary peristalsis was assessed by rapid air injections after water swallows. Two sessions were randomly performed including acute administration of sildenafil 50 mg after pre-treatment with prucalopride or the placebo.
RESULTS


The frequency of primary peristalsis subsequent to the administration of sildenafil was significantly increased by prucalopride (P = 0.02). Prucalopride also significantly increased distal contractile integral (DCI) of primary peristalsis subsequent to the administration of sildenafil (P = 0.03). No difference in the frequency of secondary peristalsis subsequent to the administration of sildenafil for air injects of 10 mL (P = 0.14) or 20 mL (P = 0.21) was found between prucalopride and placebo. Prucalopride didn't change DCI of secondary peristalsis subsequent to the administration of sildenafil for air injections of 10 mL (P = 0.09) or 20 mL (P = 0.12).
CONCLUSIONS


Prucalopride modulates sildenafil-induced inhibition of primary peristalsis by increasing its effectiveness and peristaltic wave amplitude. Our findings suggest that activation of 5-HT 4  receptors plays a role in mediating sildenafil-induced inhibition of esophageal primary peristalsis rather than secondary peristalsis.",2020,No difference in the frequency of secondary peristalsis subsequent to the administration of sildenafil for air injects of 10 mL (P = 0.14) or 20 mL (P = 0.21) was found between prucalopride and placebo.,"['Seventeen healthy adults underwent high resolution manometry by a catheter with one injection port located in mid-esophagus', 'healthy adults']","['prucalopride', 'sildenafil', 'placebo', 'sildenafil 50 mg after pre-treatment with prucalopride or the placebo']",['distal contractile integral (DCI'],"[{'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0024751', 'cui_str': 'Manometry'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0452253', 'cui_str': 'Port'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0014876', 'cui_str': 'Esophageal structure'}]","[{'cui': 'C0913506', 'cui_str': 'prucalopride'}, {'cui': 'C0529793', 'cui_str': 'sildenafil'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0989894', 'cui_str': 'sildenafil 50 MG'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0026820', 'cui_str': 'Muscle contraction'}, {'cui': 'C0443238', 'cui_str': 'Integral'}]",17.0,0.115889,No difference in the frequency of secondary peristalsis subsequent to the administration of sildenafil for air injects of 10 mL (P = 0.14) or 20 mL (P = 0.21) was found between prucalopride and placebo.,"[{'ForeName': 'Ming-Wun', 'Initials': 'MW', 'LastName': 'Wong', 'Affiliation': 'Department of Medicine, Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation and Tzu Chi University, Hualien, Taiwan.'}, {'ForeName': 'Tso-Tsai', 'Initials': 'TT', 'LastName': 'Liu', 'Affiliation': 'Department of Medicine, Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation and Tzu Chi University, Hualien, Taiwan.'}, {'ForeName': 'Chih-Hsun', 'Initials': 'CH', 'LastName': 'Yi', 'Affiliation': 'Department of Medicine, Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation and Tzu Chi University, Hualien, Taiwan.'}, {'ForeName': 'Jui-Sheng', 'Initials': 'JS', 'LastName': 'Hung', 'Affiliation': 'Department of Medicine, Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation and Tzu Chi University, Hualien, Taiwan.'}, {'ForeName': 'Wei-Yi', 'Initials': 'WY', 'LastName': 'Lei', 'Affiliation': 'Department of Medicine, Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation and Tzu Chi University, Hualien, Taiwan.'}, {'ForeName': 'Shu-Wei', 'Initials': 'SW', 'LastName': 'Liang', 'Affiliation': 'Department of Medicine, Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation and Tzu Chi University, Hualien, Taiwan.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Orr', 'Affiliation': 'Lynn Institute for Healthcare Research, University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, USA.'}, {'ForeName': 'Chien-Lin', 'Initials': 'CL', 'LastName': 'Chen', 'Affiliation': 'Department of Medicine, Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation and Tzu Chi University, Hualien, Taiwan.'}]",Journal of gastroenterology and hepatology,['10.1111/jgh.15305']
1691,33080088,Efficacy and safety of dronedarone by atrial fibrillation history duration: Insights from the ATHENA study.,"BACKGROUND


Atrial fibrillation/atrial flutter (AF/AFL) burden increases with increasing duration of AF/AFL history.
HYPOTHESIS


Outcomes with dronedarone may also be impacted by duration of AF/AFL history.
METHODS


In this post hoc analysis of ATHENA, efficacy and safety of dronedarone vs placebo were assessed in groups categorized by time from first known AF/AFL episode to randomization (ie, duration of AF/AFL history): <3 months (short), 3 to <24 months (intermediate), and ≥ 24 months (long).
RESULTS


Of 2859 patients with data on duration of AF/AFL history, 45.3%, 29.6%, and 25.1% had short, intermediate, and long histories, respectively. Patients in the long history group had the highest prevalence of structural heart disease and were more likely to be in AF/AFL at baseline. Placebo-treated patients in the long history group also had the highest incidence of AF/AFL recurrence and cardiovascular (CV) hospitalization during the study. The risk of first CV hospitalization/death from any cause was lower with dronedarone vs placebo in patients with short (hazard ratio, 0.79 [95% confidence interval: 0.65-0.96]) and intermediate (0.72 [0.56-0.92]) histories; a trend favoring dronedarone was also observed in patients with long history (0.84 [0.66-1.07]). A similar pattern was observed for first AF/AFL recurrence. No new drug-related safety issues were identified.
CONCLUSIONS


Patients with long AF/AFL history had the highest burden of AF/AFL at baseline and during the study. Dronedarone significantly improved efficacy vs placebo in patients with short and intermediate AF/AFL histories. While exploratory, these results support the potential value in initiating rhythm control treatment early in patients with AF/AFL.",2020,"The risk of first CV hospitalization/death from any cause was lower with dronedarone vs placebo in patients with short (hazard ratio, 0.79 [95% confidence interval: 0.65-0.96]) and intermediate (0.72 [0.56-0.92]) histories; a trend favoring dronedarone was also observed in patients with long history (0.84 [0.66-1.07]).","['groups categorized by time from first known AF/AFL episode to randomization (ie, duration of AF/AFL history', 'patients with AF/AFL', 'patients with short and intermediate AF/AFL histories', '2859 patients with data on duration of AF/AFL history, 45.3%, 29.6%, and 25.1% had short, intermediate, and long histories, respectively']","['Dronedarone', 'dronedarone', 'placebo', 'Placebo', 'dronedarone vs placebo']","['efficacy', 'highest prevalence of structural heart disease', 'highest burden of AF/AFL', 'efficacy and safety', 'Efficacy and safety', 'risk of first CV hospitalization/death', 'highest incidence of AF/AFL recurrence and cardiovascular (CV) hospitalization']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0205166', 'cui_str': 'Long'}]","[{'cui': 'C0766326', 'cui_str': 'dronedarone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0018799', 'cui_str': 'Heart disease'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]",2859.0,0.0325847,"The risk of first CV hospitalization/death from any cause was lower with dronedarone vs placebo in patients with short (hazard ratio, 0.79 [95% confidence interval: 0.65-0.96]) and intermediate (0.72 [0.56-0.92]) histories; a trend favoring dronedarone was also observed in patients with long history (0.84 [0.66-1.07]).","[{'ForeName': 'Carina', 'Initials': 'C', 'LastName': 'Blomström-Lundqvist', 'Affiliation': 'Department of Medical Science and Cardiology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Nassir', 'Initials': 'N', 'LastName': 'Marrouche', 'Affiliation': 'Section of Cardiology, Tulane University Heart and Vascular Institute, New Orleans, Louisiana, USA.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Connolly', 'Affiliation': 'Population Health Research Institute, Hamilton, Canada.'}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Corp Dit Genti', 'Affiliation': 'Sanofi-Aventis, Paris, France.'}, {'ForeName': 'Mattias', 'Initials': 'M', 'LastName': 'Wieloch', 'Affiliation': 'Sanofi-Aventis, Paris, France.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Koren', 'Affiliation': 'Sanofi, Bridgewater, New Jersey, at the time of the study, USA.'}, {'ForeName': 'Stefan H', 'Initials': 'SH', 'LastName': 'Hohnloser', 'Affiliation': 'Department of Cardiology, Division of Clinical Electrophysiology, J. W. Goethe University, Frankfurt, Germany.'}]",Clinical cardiology,['10.1002/clc.23463']
1692,33080122,"Walking in multiple sclerosis improves with tDCS: a randomized, double-blind, sham-controlled study.","OBJECTIVE


To evaluate whether multiple sessions of transcranial direct current stimulation (tDCS) applied to the primary motor (M1) cortex paired with aerobic exercise can improve walking functions in multiple sclerosis (MS).
METHODS


MS participants were recruited for a double-blind, parallel-arm, randomized, sham-controlled trial and assigned to 10 sessions (5 d/wk for 2 weeks) of either active or sham tDCS paired with unloaded cycling for 20 minutes. Stimulation was administered over the left M1 cortex (2.5 mA; anode over C3/cathode over FP2). Gait spatiotemporal parameters were assessed using a wearable inertial sensor (10-meter and 2-minute walking tests). Measurements were collected at baseline, end of tDCS intervention, and 4-week postintervention to test for duration of any benefits.
RESULTS


A total of 15 participants completed the study, nine in the active and six in the sham condition. The active and sham groups were matched according to gender (50% vs. 40% female), neurologic disability (median EDSS 5.5 vs. 5), and age (mean 52.1 ± 12.9 vs. 53.7 ± 9.8 years). The active group had a significantly greater increase in gait speed (0.87 vs. 1.20 m/s, p < 0.001) and distance covered during the 2-minute walking test (118.53 vs. 133.06 m, p < 0.001) at intervention end compared to baseline. At 4-week follow-up, these improvements were maintained (baseline vs. follow-up: gait speed 0.87 vs. 1.18 m/s, p < 0.001; distance traveled 118.53 vs. 143.82 m, p < 0.001).
INTERPRETATION


Multiple sessions of tDCS paired with aerobic exercise lead to cumulative and persisting improvements in walking and endurance in patients with MS.",2020,"The active group had a significantly greater increase in gait speed (0.87 vs. 1.20 m/s, p < 0.001) and distance covered during the 2-minute walking test (118.53 vs. 133.06 m, p < 0.001) at intervention end compared to baseline.","['multiple sclerosis (MS', '15 participants completed the study, nine in the active and six in the sham condition', 'median EDSS 5.5 vs. 5), and age (mean 52.1\xa0±\xa012.9 vs. 53.7\xa0±\xa09.8\xa0years', 'patients with MS', 'MS participants']","['transcranial direct current stimulation (tDCS', 'tDCS', 'aerobic exercise', 'active or sham tDCS paired with unloaded cycling for 20\xa0minutes']","['walking functions', 'neurologic disability', 'Gait spatiotemporal parameters', 'duration of any benefits', 'gait speed']","[{'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0439232', 'cui_str': 'min'}]","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}]",15.0,0.418567,"The active group had a significantly greater increase in gait speed (0.87 vs. 1.20 m/s, p < 0.001) and distance covered during the 2-minute walking test (118.53 vs. 133.06 m, p < 0.001) at intervention end compared to baseline.","[{'ForeName': 'Giuseppina', 'Initials': 'G', 'LastName': 'Pilloni', 'Affiliation': 'Department of Neurology, NYU Langone Health, New York, NY, USA.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Choi', 'Affiliation': 'Department of Medicine, SUNY Downstate, New York, NY, USA.'}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Shaw', 'Affiliation': 'Department of Psychology, Binghamton University, New York, NY, USA.'}, {'ForeName': 'Giancarlo', 'Initials': 'G', 'LastName': 'Coghe', 'Affiliation': 'Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Krupp', 'Affiliation': 'Department of Neurology, NYU Langone Health, New York, NY, USA.'}, {'ForeName': 'Marilyn', 'Initials': 'M', 'LastName': 'Moffat', 'Affiliation': 'Department of Physical Therapy, New York University, New York, NY, USA.'}, {'ForeName': 'Eleonora', 'Initials': 'E', 'LastName': 'Cocco', 'Affiliation': 'Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Massimiliano', 'Initials': 'M', 'LastName': 'Pau', 'Affiliation': 'Department of Mechanical, Chemical and Materials Engineering, University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Leigh', 'Initials': 'L', 'LastName': 'Charvet', 'Affiliation': 'Department of Neurology, NYU Langone Health, New York, NY, USA.'}]",Annals of clinical and translational neurology,['10.1002/acn3.51224']
1693,33080208,Comparing the Effects of Tongue-In-Groove and Septocolumellar Suture With Short and Floating Columellar Strut of Open Rhinoplasty on Nasal Tip Rotation and Projection.,"PURPOSE


In rhinoplasty, it is important to maintain the desired tip projection and rotation. The aim of the present study was to compare tongue-in-groove (TIG) method and the septocolumellar suture method with short and floating columellar strut methods over a six-month follow-up period.
METHODS


A total of 69 patients were evaluated. The TIG method was used on 39 patients (group 1, TIG group), and the remaining 30 patients received septocolumellar suture supported with short and floating columellar strut (group 2, suture + graft group). Standardized right profile images were taken preoperatively and six months after the operations. Goode's method and nasofacial angle were used to evaluate nasal tip projection, and the nasolabial angle was measured to evaluate tip rotation. The outcomes of the two surgical approaches were compared, and P values lower than 0.05 were considered significant.
RESULTS


Although nasal tip rotation in the postoperative sixth month was higher than that in the preoperative period in both groups (TIG: 96.8° vs 108.2° and suture + graft: 100.8° vs 104.2°, respectively), this change was significant only in the TIG group (P < .001). Goode's ratio increased significantly in both groups compared with the postoperative period (TIG: 0.62 vs 0.57 and suture + graft: 0.62 vs 0.58; P < .001 and .047, respectively). On the other hand, nasofacial angle decreased significantly in both groups compared with the postoperative period (TIG: 147.8° vs 144.0° and suture + graft: 149.1° vs 146.3°; P < .001).
CONCLUSIONS


As per the results of the present study, both studied methods can be safely used in nasal tip surgery. Compared with the septocolumellar suture + columellar strut method, the TIG method resulted in a higher rotation increase. Both methods led to significant increases in projection, and these increases did not differ between the groups.",2020,"Goode's ratio increased significantly in both groups compared with the postoperative period (TIG: 0.62 vs 0.57 and suture + graft: 0.62 vs 0.58; P < .001 and .047, respectively).",['A total of 69 patients were evaluated'],"['septocolumellar suture method with short and floating columellar strut methods', 'suture\xa0+\xa0graft', 'Tongue-In-Groove and Septocolumellar Suture With Short and Floating Columellar Strut of Open Rhinoplasty', 'septocolumellar suture supported with short and floating columellar strut (group 2, suture\xa0+\xa0graft group']","['nasofacial angle', ""Goode's ratio""]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0441295', 'cui_str': 'Strut'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0040408', 'cui_str': 'Tongue structure'}, {'cui': 'C0396086', 'cui_str': 'Open rhinoplasty'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",69.0,0.021764,"Goode's ratio increased significantly in both groups compared with the postoperative period (TIG: 0.62 vs 0.57 and suture + graft: 0.62 vs 0.58; P < .001 and .047, respectively).","[{'ForeName': 'Ceyhun', 'Initials': 'C', 'LastName': 'Aksakal', 'Affiliation': 'Associate Professor, Department of Otorhinolaryngology, Gaziosmanpaşa University Medical School, Tokat, Turkey. Electronic address: aksakalceyhun@gmail.com.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2020.09.030']
1694,33080291,Effects of nicotine on pupil size and performance during multiple-object tracking in non-nicotine users.,"Nicotine has been commonly used in pyschopharmacological studies, showing its benefits as a pharmacological stimulant on cognitive performance. In the current study, we investigated the effects of 2 mg (Experiment 1) and 4 mg (Experiment 2) of nicotine on performance on a multiple-object-tracking task. Participants were young non-smoking adults with no pre-existing attentional deficits. Nicotine and placebo were administered through nicotine and nicotine-free taste-matched chewing gum, respectively. Additionally, we compared pupil size between nicotine and placebo conditions in both experiments. Although we found that pupil size was considerably smaller in the nicotine conditions, nicotine administration did not appear to facilitate behavioural performance. We speculate that nicotine might enhance performance only for certain cognitive functions, and only for specific populations, such as nicotine-deprived smokers.",2020,"Although we found that pupil size was considerably smaller in the nicotine conditions, nicotine administration did not appear to facilitate behavioural performance.","['Participants were young non-smoking adults with no pre-existing attentional deficits', 'non-nicotine users']","['nicotine', 'Nicotine', 'nicotine and nicotine-free taste-matched chewing gum', 'Nicotine and placebo']","['behavioural performance', 'pupil size and performance during multiple-object tracking', 'pupil size']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C4302494', 'cui_str': 'Nicotine user'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0039336', 'cui_str': 'Finding of sense of taste'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0008037', 'cui_str': 'Chewing Gum'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0517965', 'cui_str': 'Size of pupil'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0347997', 'cui_str': 'Physical object'}]",,0.0190549,"Although we found that pupil size was considerably smaller in the nicotine conditions, nicotine administration did not appear to facilitate behavioural performance.","[{'ForeName': 'I K', 'Initials': 'IK', 'LastName': 'Wardhani', 'Affiliation': 'Department of Psychology, University of Oslo, Forskningsveien 3A, 0373 Oslo, Norway; Department of Experimental Psychology, University of Groningen, Grote Kruisstraat 2/1, 9712 TS Groningen, the Netherlands; Department of Experimental Psychology, Ghent University, Henri Dunantlaan 2, 9000 Ghent, Belgium. Electronic address: intankusuma.wardhani@ugent.be.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Mathôt', 'Affiliation': 'Department of Experimental Psychology, University of Groningen, Grote Kruisstraat 2/1, 9712 TS Groningen, the Netherlands.'}, {'ForeName': 'C N', 'Initials': 'CN', 'LastName': 'Boehler', 'Affiliation': 'Department of Experimental Psychology, Ghent University, Henri Dunantlaan 2, 9000 Ghent, Belgium.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Laeng', 'Affiliation': 'Department of Psychology, University of Oslo, Forskningsveien 3A, 0373 Oslo, Norway.'}]",International journal of psychophysiology : official journal of the International Organization of Psychophysiology,['10.1016/j.ijpsycho.2020.09.005']
1695,33080294,The effects of an internet-based mindfulness meditation intervention on electrophysiological markers of attention.,"Evidence suggests that mindfulness meditation training has the potential to train aspects of attention. However, the neurophysiological mechanisms underpinning the attentional benefits from mindfulness remain unclear. This randomized controlled trial examined changes in electrophysiological markers of attention before and after completion of a 6-week internet-based mindfulness intervention. EEG and ERP data were collected from 64 generally healthy, mildly stressed older adults. Participants were randomized to an internet-based mindfulness-based stress reduction course (IMMI), an internet-based health and wellness education course, or a wait list control condition. Attentional N2 and P3 evoked potentials were derived from active and passive auditory oddball paradigms. Participants in the IMMI group showed significantly greater differences in P3 peak-trough amplitude between the active and passive oddball paradigms at endpoint relative to controls. There were no significant relationships between the intervention and N2 potentials. Our data demonstrate a measurable increase in attentional control when discriminating or directing attention away from auditory stimuli for older adult participants who received mindfulness training. These findings lend support to the use of the P3 as a neurophysiological measure of meditation engagement and intervention efficacy.",2020,Participants in the IMMI group showed significantly greater differences in P3 peak-trough amplitude between the active and passive oddball paradigms at endpoint relative to controls.,"['64 generally healthy, mildly stressed older adults']","['internet-based mindfulness meditation intervention', 'mindfulness meditation training', 'internet-based mindfulness-based stress reduction course (IMMI), an internet-based health and wellness education course, or a wait list control condition', '6-week internet-based mindfulness intervention']","['attentional control', 'P3 peak-trough amplitude', 'Attentional N2 and P3 evoked potentials']","[{'cui': 'C2945599', 'cui_str': 'Mild'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}]",64.0,0.0204774,Participants in the IMMI group showed significantly greater differences in P3 peak-trough amplitude between the active and passive oddball paradigms at endpoint relative to controls.,"[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Klee', 'Affiliation': 'Oregon Health & Science University, Department of Neurology, United States of America. Electronic address: klee@ohsu.edu.'}, {'ForeName': 'Dana Dharmakaya', 'Initials': 'DD', 'LastName': 'Colgan', 'Affiliation': 'Oregon Health & Science University, Department of Neurology, United States of America.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Hanes', 'Affiliation': 'National University of Natural Medicine, United States of America.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Oken', 'Affiliation': 'Oregon Health & Science University, Department of Neurology, United States of America; Oregon Health & Science University, Departments of Behavioral Neuroscience and Biomedical Engineering, United States of America.'}]",International journal of psychophysiology : official journal of the International Organization of Psychophysiology,['10.1016/j.ijpsycho.2020.10.002']
1696,33080376,Comparison of Adverse Events Between Cervical Disc Arthroplasty and Anterior Cervical Discectomy and Fusion: A 10-year Follow-up.,"BACKGROUND CONTEXT


Cervical disc arthroplasty (CDA) has been advocated as an alternative to anterior cervical discectomy and fusion (ACDF) with the added potential to reduce the risk of adjacent level disc degeneration and segmental instability. However, the long-term adverse events of arthroplasty have yet to be fully reported.
PURPOSE


To investigate the 10 year follow-up adverse events rates between CDA and ACDF.
STUDY DESIGN/SETTING


The study was a randomized, prospective, multicenter Investigational Device Exemption (IDE) trial and its continued follow-up as a post-approval study (PAS). Single level surgeries were performed for cervical disc pathologies between May 2002 and October 2004.
PATIENT SAMPLE


n=463 patients.
OUTCOME MEASURES


Adverse events comparison of CDA and ACDF from self-reported and physiologic measures.
METHODS


At each evaluation time point, subjects were queried for adverse events since their last visit; and all adverse events were documented, regardless of whether or not they appeared related to the surgery or device. Adverse events were recorded, categorized, and assessed for severity and relationship to the study device and/or surgical procedure. The 10-year cumulative rates for each type of adverse events were summarized using a life-table method for the time-to-event analysis. A log-rank test was used to compare the two treatment groups.
RESULTS


A total of 242 patients received CDA and 221 patients received ACDF. At 10 years follow up, 54% (130/242) of CDA patients and 47% (104/221) of the ACDF subjects were evaluated. At up to 10-year follow-up, 231 patients in the CDA group (cumulative rate 98.4%) and 199 patients in the ACDF group (cumulative rate 98.7%) had at least one adverse event. Overall, the difference in the cumulative rate of all adverse events over 10 years was not statistically different (p = 0.166). The cumulative rates of the following adverse events were not different between the two groups for cancer, cardiovascular, death, dysphonia/dysphagia, gastrointestinal, infection, urogenital, respiratory, implant displacement/loosening, implant malposition, neck and arm pain, neurological, other pain, spinal events, urogenital and intraoperative vascular injury. However, there were more adverse events in the CDA group resulting from trauma (p = 0.012) and more spinal events at the index level (p = 0.006). The ACDF group had significantly more non-union events (p = 0.019), and non-union outcome pending (p = 0.034), adjacent level spinal events (p = 0.033), and events that fell into the ""other"" category (p = 0.015).
CONCLUSIONS


The cumulative rates of patients who had any adverse events were not different between the artificial cervical disc and the anterior cervical arthrodesis groups. In addition, the cumulative rates were not different between the two groups for the majority of categories as well.",2020,"However, there were more adverse events in the CDA group resulting from trauma (p = 0.012) and more spinal events at the index level (p = 0.006).","['SAMPLE\n\n\nn=463 patients', 'Cervical Disc Arthroplasty and Anterior Cervical Discectomy and Fusion', '242 patients received CDA and 221 patients received']","['CDA', 'Cervical disc arthroplasty (CDA', 'ACDF']","['adjacent level spinal events', '10-year cumulative rates', 'spinal events', 'cumulative rate of all adverse events', 'Adverse events', 'adverse events', 'cumulative rates', 'non-union events', 'cancer, cardiovascular, death, dysphonia/dysphagia, gastrointestinal, infection, urogenital, respiratory, implant displacement/loosening, implant malposition, neck and arm pain, neurological, other pain, spinal events, urogenital and intraoperative vascular injury']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0003893', 'cui_str': 'Arthroplasty'}, {'cui': 'C0442011', 'cui_str': 'Anterior cervical spine approach'}, {'cui': 'C0206078', 'cui_str': 'Discectomy of spine'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}]","[{'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0003893', 'cui_str': 'Arthroplasty'}, {'cui': 'C4552416', 'cui_str': 'ACDF'}]","[{'cui': 'C0205117', 'cui_str': 'Juxta-posed'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019825', 'cui_str': 'Hoarse'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0042066', 'cui_str': 'Structure of genitourinary system'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C0333050', 'cui_str': 'Loosening'}, {'cui': 'C4552558', 'cui_str': 'Implant malposition'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0239377', 'cui_str': 'Pain in upper limb'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0178324', 'cui_str': 'Injury of blood vessel'}]",242.0,0.0632128,"However, there were more adverse events in the CDA group resulting from trauma (p = 0.012) and more spinal events at the index level (p = 0.006).","[{'ForeName': 'Travis', 'Initials': 'T', 'LastName': 'Loidolt', 'Affiliation': 'Travis Loidolt: Department of Orthopedic Surgery, SUNY Upstate Medical University, 750 E. Adams St., Syracuse, NY 13210 USA. Electronic address: drloidolt@toscnorcal.com.'}, {'ForeName': 'Swamy', 'Initials': 'S', 'LastName': 'Kurra', 'Affiliation': 'Swamy Kurra: Department of Orthopedic Surgery, SUNY Upstate Medical University, 750 E. Adams St., Syracuse, NY 13210 USA. Electronic address: swamy_mbbs@yahoo.com.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Daniel Riew', 'Affiliation': 'K. Daniel Riew: Professor of Orthopedic Surgery, Columbia University Medical Center, 51 W. 51(st) St, #370, New York, NY 10019 USA. Electronic address: kr2637@cumc.columbia.edu.'}, {'ForeName': 'Allan D', 'Initials': 'AD', 'LastName': 'Levi', 'Affiliation': 'Allan D. Levi: Department of Neurological Surgery, University of Miami, Miller School of Medicine, 1095 NW 14(th) Terrace, Miami, FL 33136 USA. Electronic address: alevi@med.miami.edu.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Florman', 'Affiliation': 'Jeffrey Florman: Neurological Surgery, Maine Medical Center, 49 Spring St. Scarborough, ME 04074 USA. Electronic address: flormj@mmc.org.'}, {'ForeName': 'William F', 'Initials': 'WF', 'LastName': 'Lavelle', 'Affiliation': 'Travis Loidolt: Department of Orthopedic Surgery, SUNY Upstate Medical University, 750 E. Adams St., Syracuse, NY 13210 USA. Electronic address: lavellew@upstate.edu.'}]",The spine journal : official journal of the North American Spine Society,['10.1016/j.spinee.2020.10.013']
1697,33080406,Atelectasis prevention during anaesthesia using high-flow nasal cannula therapy: A paediatric randomised trial using MRI images.,"BACKGROUND


Atelectasis frequently occurs early on during anaesthesia in children. We hypothesised that positive expiratory pressure (PEP) generated via high-flow nasal cannula (HFNC) could prevent atelectasis in non-intubated children under general anaesthesia. The objective was to compare the volume of atelectasis present in patients treated via HFNC to that of patients treated via a face bag-mask without PEP. The outcome used for this comparison was the ratio of the atelectasis volume to the total pulmonary volume.
METHODS


A prospective single-centre, single-blind, randomised trial was conducted in a tertiary hospital from November 2018 through May 2019. The trial subjects were infants and children between six months and six years of age who required anaesthesia for an MRI. The children were randomised to receive sevoflurane for maintenance of anaesthesia either via a classic face bag mask or by HFNC. The atelectasis volume was measured from thoracic MRI images. The judgment criterion was the ratio of the atelectasis volume to the lung volume.
RESULTS


Of a trial group of 42 patients, 21 received anaesthesia via a face bag-mask and 21 via HFNC. After three patients were excluded for technical issues, the data for 39 patients were analysed. The atelectasis volume to the lung volume ratio in the HFNC group was significantly smaller than the ratio for the face bag-mask group (1.6% vs 6.8%, respectively; p=0.002).
CONCLUSION


HFNC was associated with a lower atelectasis lung ratio compared to using a face bag-mask during anaesthesia for children maintained with spontaneous ventilation.",2020,HFNC was associated with a lower atelectasis lung ratio compared to using a face bag-mask during anaesthesia for children maintained with spontaneous ventilation.,"['42 patients, 21 received anaesthesia via a face bag-mask and 21 via HFNC', 'tertiary hospital from November 2018 through May 2019', 'patients treated via HFNC to that of patients treated via a face bag-mask without PEP', 'children', 'trial subjects were infants and children between six months and six years of age who required anaesthesia for an MRI']","['anaesthesia either via a classic face bag mask or by HFNC', 'HFNC', 'Atelectasis prevention during anaesthesia using high-flow nasal cannula therapy', 'positive expiratory pressure (PEP) generated via high-flow nasal cannula (HFNC', 'sevoflurane']","['ratio of the atelectasis volume to the total pulmonary volume', 'atelectasis volume to the lung volume ratio', 'atelectasis volume']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0179196', 'cui_str': 'Bag'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannulae'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0439658', 'cui_str': 'Classic'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0179196', 'cui_str': 'Bag'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannulae'}, {'cui': 'C0004144', 'cui_str': 'Atelectasis'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0004144', 'cui_str': 'Atelectasis'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0231953', 'cui_str': 'Lung volume'}]",39.0,0.0737043,HFNC was associated with a lower atelectasis lung ratio compared to using a face bag-mask during anaesthesia for children maintained with spontaneous ventilation.,"[{'ForeName': 'César', 'Initials': 'C', 'LastName': 'Roncin', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Hôpital Nord, Assistance Publique Hôpitaux de Marseille, 13015 Marseille, France. Electronic address: cesarroncin@gmail.com.'}, {'ForeName': 'Ugo', 'Initials': 'U', 'LastName': 'Scemama', 'Affiliation': 'Department of Medical Imaging, Hôpital Nord, Hôpital Nord, Assistance Publique Hôpitaux de Marseille, 13015 Marseille, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Zieleskiewicz', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Hôpital Nord, Assistance Publique Hôpitaux de Marseille, 13015 Marseille, France.'}, {'ForeName': 'Anderson', 'Initials': 'A', 'LastName': 'Loundou', 'Affiliation': 'Methodological Assistance to Clinical Research, Department of Public Health, Faculty of Medicine, Aix-Marseille University, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Lesavre', 'Affiliation': 'Clinical Investigations Center, CIC 1409, Hôpital Nord, Assitance Publique Hôpitaux de Marseille, Aix-Marseille University, France.'}, {'ForeName': 'Renaud', 'Initials': 'R', 'LastName': 'Vialet', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Hôpital Nord, Assistance Publique Hôpitaux de Marseille, 13015 Marseille, France.'}]","Anaesthesia, critical care & pain medicine",['10.1016/j.accpm.2020.08.009']
1698,33080411,The effect of dietary nitrate on exercise capacity in chronic kidney disease a randomized Controlled pilot study.,"BACKGROUND


Chronic Kidney Disease (CKD) patients exhibit a reduced exercise capacity that impacts quality of life. Dietary nitrate supplementation has been shown to have favorable effects on exercise capacity in disease populations by reducing the oxygen cost of exercise. This study investigated whether dietary nitrates would acutely improve exercise capacity in CKD patients.
METHODS AND RESULTS


In this randomized, double-blinded crossover study, 12 Stage 3-4 CKD patients (Mean±SEM: Age, 60 ± 5yrs; eGFR, 50.3 ± 4.6ml/min/1.73m 2 ) received an acute dose of 12.6 mmol of dietary nitrate in the form of concentrated beetroot juice (BRJ) and a nitrate depleted placebo (PLA). Skeletal muscle mitochondrial oxidative function was assessed using near-infrared spectroscopy. Cardiopulmonary exercise testing was performed on a cycle ergometer, with intensity increased by 25W every 3 minutes until volitional fatigue. Plasma Nitric Oxide (NO) metabolites (NOm; nitrate, nitrite, low molecular weight S-nitrosothiols, and metal bound NO) were determined by gas-phase chemiluminescence. Plasma NOm values were significantly increased following BRJ (BRJ vs. PLA: 1074.4±120.4 uM vs. 28.4±6.6 μM, p<0.001). Total work performed (44.4 ± 10.6 vs 39.6 ± 9.9kJ, p=0.03) and total exercise time (674 ± 85 vs 627 ± 86s, p=0.04) were significantly greater following BRJ. Oxygen consumption at the ventilatory threshold was also improved by BRJ (0.90 ± 0.08 vs. 0.74 ± 0.06L/min, p=0.04). These changes occurred in the absence of improved skeletal muscle mitochondrial oxidative capacity (p=0.52) and VO 2peak  (p=0.35).
CONCLUSIONS


Our findings demonstrate that inorganic nitrate can acutely improve exercise capacity in CKD patients. The effects of chronic nitrate supplementation on CKD related exercise intolerance should be investigated in future studies.",2020,"These changes occurred in the absence of improved skeletal muscle mitochondrial oxidative capacity (p=0.52) and VO 2peak  (p=0.35).
","['12 Stage 3-4 CKD patients (Mean±SEM: Age, 60 ± 5yrs; eGFR, 50.3 ± 4.6ml/min/1.73m 2 ) received an', 'Chronic Kidney Disease (CKD) patients', 'CKD patients', 'chronic kidney disease']","['chronic nitrate supplementation', 'dietary nitrate', 'acute dose of 12.6 mmol of dietary nitrate in the form of concentrated beetroot juice (BRJ) and a nitrate depleted placebo (PLA', 'BRJ (BRJ vs. PLA', 'dietary nitrates', 'Dietary nitrate supplementation', 'inorganic nitrate']","['total exercise time', 'Oxygen consumption', 'skeletal muscle mitochondrial oxidative capacity', 'Plasma NOm values', 'Plasma Nitric Oxide (NO) metabolites (NOm; nitrate, nitrite, low molecular weight S-nitrosothiols, and metal bound', 'exercise capacity', 'Skeletal muscle mitochondrial oxidative function']","[{'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}]","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4517545', 'cui_str': '12.6'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C1095905', 'cui_str': 'Beets preparation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0429931', 'cui_str': 'Total exercise time'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0026237', 'cui_str': 'Mitochondrion'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0028137', 'cui_str': 'Nitrite salt'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0026385', 'cui_str': 'Molecular Weight'}, {'cui': 'C0141313', 'cui_str': 'S-Nitrosothiol'}, {'cui': 'C0025552', 'cui_str': 'Metal'}, {'cui': 'C0332297', 'cui_str': 'Bounded by'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",,0.142506,"These changes occurred in the absence of improved skeletal muscle mitochondrial oxidative capacity (p=0.52) and VO 2peak  (p=0.35).
","[{'ForeName': 'Meghan G', 'Initials': 'MG', 'LastName': 'Ramick', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, Newark, DE; Department of Kinesiology, West Chester University, West Chester, PA.'}, {'ForeName': 'Danielle L', 'Initials': 'DL', 'LastName': 'Kirkman', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, Newark, DE; Department of Kinesiology and Health Sciences, Virginia Commonwealth University, Richmond, VA.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Stock', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, Newark, DE.'}, {'ForeName': 'Bryce J', 'Initials': 'BJ', 'LastName': 'Muth', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, Newark, DE; School of Health Sciences, Stockton University, Stockton, NJ.'}, {'ForeName': 'William B', 'Initials': 'WB', 'LastName': 'Farquhar', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, Newark, DE.'}, {'ForeName': 'Julio A', 'Initials': 'JA', 'LastName': 'Chirinos', 'Affiliation': 'Division of Cardiovascular Medicine. Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Paschalis-Thomas', 'Initials': 'PT', 'LastName': 'Doulias', 'Affiliation': ""Laboratory of Biochemistry, Department of Chemistry, School of Sciences, University of Ioannina, Ioannina, 45110, Greece; Children's Hospital of Philadelphia Research Institute, Philadelphia, PA.""}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Ischiropoulos', 'Affiliation': ""Laboratory of Biochemistry, Department of Chemistry, School of Sciences, University of Ioannina, Ioannina, 45110, Greece; Children's Hospital of Philadelphia Research Institute, Philadelphia, PA.""}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Edwards', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, Newark, DE. Electronic address: dge@udel.edu.'}]",Nitric oxide : biology and chemistry,['10.1016/j.niox.2020.10.002']
1699,33080415,Prevention of hypotension during elective cesarean section with a fixed-rate norepinephrine infusion versus a fixed-rate phenylephrine infusion. Α double-blinded randomized controlled trial.,"BACKGROUND


Spinal anesthesia for cesarean section can be complicated by hypotension, with untoward effects for both the mother and fetus. Frequently used phenylephrine can lead to baroreceptor-mediated reflex bradycardia. The aim of the present study was to compare a fixed-rate prophylactic norepinephrine infusion to a fixed-rate prophylactic phenylephrine infusion during elective cesarean section under combined spinal-epidural anesthesia.
MATERIALS AND METHODS


Eighty-two parturients were randomized to either norepinephrine 4 μg/min or phenylephrine 50 μg/min fixed-rate infusions, starting simultaneously with the administration of the subarachnoid solution. The primary endpoint was the incidence of maternal bradycardia. Maternal hemodynamics at specific timepoints, the incidence of hypotension or hypertension, the requirement for ephedrine or atropine bolus administration as well as the acid-base status and Apgar score of the neonate were recorded.
RESULTS


The incidence of bradycardia as well as the requirement for atropine administration was lower in the norepinephrine group (4.8% vs. 31.7%, p = 0.004 and 2.4% vs. 24.3%, p = 0.01, respectively). Fetal pH, and fetal blood glucose concentration were higher in the norepinephrine group (p = 0.027 and 0.019, respectively). No difference in the occurrence of hypotension, hypertension, in the requirement for bolus vasoconstrictive medication or in Apgar scores was demonstrated.
CONCLUSIONS


A fixed-rate infusion of norepinephrine is as effective in the management of hypotension during regional anesthesia for cesarean section as a fixed-rate infusion of phenylephrine, with the avoidance of phenylephrine-induced bradycardia. The more favourable neonatal acid-base profile of noradrenaline might be due to better maintenance of placental blood flow in the noradrenaline group due to its beta action, while the higher fetal glucose concentration in the same group might result from a catecholamine-stimulated glucose metabolism increase and a β-receptor mediated insulin decrease.",2020,"No difference in the occurrence of hypotension, hypertension, in the requirement for bolus vasoconstrictive medication or in Apgar scores was demonstrated.
","['Eighty-two parturients', 'hypotension during elective cesarean section with a']","['norepinephrine', 'fixed-rate norepinephrine infusion versus a fixed-rate phenylephrine', 'norepinephrine 4 μg/min or phenylephrine 50 μg/min fixed-rate infusions, starting simultaneously with the administration of the subarachnoid solution', 'phenylephrine', 'phenylephrine infusion']","['Maternal hemodynamics', 'incidence of hypotension or hypertension', 'incidence of bradycardia', 'occurrence of hypotension, hypertension, in the requirement for bolus vasoconstrictive medication or in Apgar scores', 'fetal glucose concentration', 'Fetal pH, and fetal blood glucose concentration', 'incidence of maternal bradycardia', 'placental blood flow']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}]","[{'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0031469', 'cui_str': 'Phenylephrine'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0038527', 'cui_str': 'Subarachnoid space structure'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0003533', 'cui_str': 'Finding of Apgar score'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0427743', 'cui_str': 'Glucose concentration, test strip measurement'}, {'cui': 'C2585282', 'cui_str': 'Blood glucose concentration'}, {'cui': 'C0032043', 'cui_str': 'Placental structure'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}]",82.0,0.245385,"No difference in the occurrence of hypotension, hypertension, in the requirement for bolus vasoconstrictive medication or in Apgar scores was demonstrated.
","[{'ForeName': 'Kassiani', 'Initials': 'K', 'LastName': 'Theodoraki', 'Affiliation': '1st Department of Anesthesiology, Aretaieion University Hospital, National and Kapodistrian University of Athens, Greece. Electronic address: ktheodoraki@hotmail.com.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Hadzilia', 'Affiliation': 'Department of Anesthesiology, Alexandra General Hospital of Athens, Greece.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Valsamidis', 'Affiliation': 'Department of Anesthesiology, Alexandra General Hospital of Athens, Greece.'}, {'ForeName': 'Emmanouil', 'Initials': 'E', 'LastName': 'Stamatakis', 'Affiliation': 'Department of Anesthesiology, Alexandra General Hospital of Athens, Greece.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.10.006']
1700,33080562,Effect of Modified Constrain Induced Movement Therapy on Fatigue and Motor Performance in Sub Acute Stroke.,"OBJECTIVES


There is a little available information about the fatigue status among people receiving modified constraint induced movement therapy. The study examined such changes. The effect of using restraint on motor performance was also evaluated in sub acute phase after stroke.
MATERIALS AND METHODS


The study was designed as two group pretest and post-test study. The experimental design included a pretest and post test measures of dependent variables fatigue and motor function. All patients were recruited from the Safdurjung Hospital. 20 patients in subacute phase of stroke (3-9 months), (N = 10) mean age±SD 51.90±15.27, MAS score mean ± SD 1.90±.316 and post stroke duration mean ±SD 6.45±2.26 were included in the experimental group and (N = 10) mean age ± SD 54.10±17.42, MAS score mean ±SD 1.52±0.52 and post stroke duration mean±SD score 4.55± 2.52 were included in the control group. The subjects in the experimental group were restrained for six hours every week day with task training for 2 h per day five times a week for three weeks and the subjects in the controlled group received task training for 2 h per day five times a week for three weeks with no restrain. Motor Performance and fatigue were measured on day to day basis by Wolf Motor Function Test Scores (WMFT) and 11th item of Barrow Neurological Institute (BNI) scale in both experimental and controlled group.
RESULTS


The restraint group exhibited significant better motor performance than the controlled group. Mean difference between Pre- WMFT scores and Post WMFT scores were (0.533±.362) as compared to controlled group (0.192±.23). No significant statistical difference was observed in the difference of mean Pre- BNI and Post - BNI scores in either of the two groups (p = .57). Difference between the experimental and controlled group in motor performance and fatigue scores were nonsignificant.
CONCLUSIONS


Restraint improves motor performance in subacute therapy group and the intensive practice associated with m-CIMT may be administered without the exacerbation of fatigue.",2020,No significant statistical difference was observed in the difference of mean Pre- BNI and Post - BNI scores in either of the two groups (p = .57).,"['sub acute phase after stroke', 'Sub Acute Stroke', '20 patients in subacute phase of stroke (3-9 months), (N = 10) mean', 'All patients were recruited from the Safdurjung Hospital', 'mean ±SD 6.45±2.26 were included in the experimental group and (N = 10']","['task training', 'Modified Constrain Induced Movement Therapy', 'Restraint']","['Motor Performance and fatigue', 'motor performance', 'motor performance and fatigue scores', 'mean Pre- BNI and Post - BNI scores', 'MAS score mean ± SD 1.90±.316 and post stroke duration', 'Pre- WMFT scores and Post WMFT scores', 'Wolf Motor Function Test Scores (WMFT) and 11th item of Barrow Neurological Institute (BNI) scale', 'Fatigue and Motor Performance']","[{'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0439557', 'cui_str': 'Acute phase'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0751956', 'cui_str': 'Acute stroke'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205365', 'cui_str': 'Subacute'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0454279', 'cui_str': 'Movement therapy'}, {'cui': 'C0035260', 'cui_str': 'Physical restraint'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0325001', 'cui_str': 'Wolf'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",20.0,0.0452297,No significant statistical difference was observed in the difference of mean Pre- BNI and Post - BNI scores in either of the two groups (p = .57).,"[{'ForeName': 'Wassim', 'Initials': 'W', 'LastName': 'Mushtaq', 'Affiliation': 'Jamia Hamdard, India. Electronic address: Woohaw88@yahoo.com.'}, {'ForeName': 'Nusrat', 'Initials': 'N', 'LastName': 'Hamdani', 'Affiliation': 'Jamia Hamdard University, India. Electronic address: nhamdani@jamiahamdard.ac.in.'}, {'ForeName': 'Majumi M', 'Initials': 'MM', 'LastName': 'Noohu', 'Affiliation': 'Centre for Physiotherapy and Rehablitation Sciences, Jamia Milia University, New Delhi, India. Electronic address: majuminoohu@gmail.com.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Raghavan', 'Affiliation': 'Safdurjung Hospital New Delhi, India. Electronic address: raghavansamudrala@yahoo.com.'}]",Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association,['10.1016/j.jstrokecerebrovasdis.2020.105378']
1701,33080594,"Characteristics of Patients in Treatment for Alcohol and Drug Addiction Who Succeed in Changing Smoking, Weight, and Physical Activity: A Secondary Analysis of an RCT on Combined Lifestyle Interventions.","INTRODUCTION


Patients addicted to alcohol or drug often have additional unhealthy lifestyles, adding to the high mortality and morbidity in this patient group. Therefore, it is important to consider lifestyle interventions as part of the usual addiction treatment.
OBJECTIVE


The aim was to identify predictors of successful changes in lifestyle risk factors among patients in treatment for alcohol or drug addiction.
METHODS


We conducted a secondary analysis of a trial using a 6-week intensive integrated lifestyle intervention: The very integrated program (VIP). Patients were recruited in Addiction Centres Malmö and Psychiatry Skåne, Sweden. The primary outcome was successful changes in lifestyle, measured as quitting tobacco, exercising 30 min per day, and not being over- or underweight after 6 weeks and 12 months.
RESULTS


A total of 212 patients were included in the RCT, and 128 were included in this secondary analysis: 108 at 6 weeks and 89 at 12 months of follow-up. A total of 69 patients were respondents at both follow-ups. The follow-up rates were 51 and 42%, respectively. More education, having at least 2 lifestyle risk factors and having a high quality of life were predictors of a successful change in lifestyle after 6 weeks. After 12 months, the predictors for a successful outcome were having 3 or more risk factors, while an education level up to 3 years was a negative predictor.
CONCLUSIONS


Having several unhealthy lifestyles in addition to alcohol and drug addiction was a significant predictor of successful lifestyle changes in the short- and long term after the VIP for lifestyle interventions. Likewise, education was significant. The results should be considered in future development and research among this vulnerable group of patients.",2020,"More education, having at least 2 lifestyle risk factors and having a high quality of life were predictors of a successful change in lifestyle after 6 weeks.","['A total of 212 patients were included in the RCT, and 128 were included in this secondary analysis: 108 at 6 weeks and 89 at 12 months of follow-up', 'Patients were recruited in Addiction Centres Malmö and Psychiatry Skåne, Sweden', '69 patients were respondents at both follow-ups', 'Patients in Treatment for Alcohol and Drug Addiction', 'patients in treatment for alcohol or drug addiction']",['intensive integrated lifestyle intervention'],"['Changing Smoking, Weight, and Physical Activity', 'successful changes in lifestyle, measured as quitting tobacco, exercising 30 min per day, and not being over- or underweight']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0085281', 'cui_str': 'Addiction'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C1510472', 'cui_str': 'Drug dependence'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0041667', 'cui_str': 'Underweight'}]",212.0,0.036991,"More education, having at least 2 lifestyle risk factors and having a high quality of life were predictors of a successful change in lifestyle after 6 weeks.","[{'ForeName': 'Mette', 'Initials': 'M', 'LastName': 'Rasmussen', 'Affiliation': 'Department of Health Sciences, Clinical Health Promotion Centre, WHO-CC, Lund University, Lund, Sweden, mette.rasmussen.03@regionh.dk.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Hovhannisyan', 'Affiliation': 'Clinical Health Promotion Centre, WHO-CC, The Parker Institute, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Adami', 'Affiliation': 'Sophiahemmet University, Stockholm, Sweden.'}, {'ForeName': 'Hanne', 'Initials': 'H', 'LastName': 'Tønnesen', 'Affiliation': 'Department of Health Sciences, Clinical Health Promotion Centre, WHO-CC, Lund University, Lund, Sweden.'}]",European addiction research,['10.1159/000510608']
1702,33080604,Tempeh Consumption and Cognitive Improvement in Mild Cognitive Impairment.,"INTRODUCTION


Tempeh consumption has been linked to the improvement of cognitive function in older people. However, to what extent the amount of microorganism or the size of tempeh serving consumed per day influences the benefit to cognitive functions has not yet been studied.
METHODS


This experimental study involved a total of 90 respondents, who were divided into 3 groups: group A (consuming 100 g of Tempeh A/day), group B (consuming 100 g of Tempeh B/day), and group C (control). Intervention was given for 6 months. Cognitive assessments were done before and after the intervention. Blood uric acid level was checked at the end of intervention to examine the effect of tempeh consumption on this. The inclusion criteria were respondents aged 60 years or over with mild cognitive impairment (MCI) who agreed not to consume other fermented food during the study period. Respondents with diabetes were excluded.
RESULTS


There were 84 subjects at the end of the study, majority being female (71.4%) and aged over 65 years (72.6%). An increase in global cognitive scores was found in both groups A and B. The increase in language domain scores was found only in group A.
CONCLUSION


Both Tempeh A or Tempeh B consumption for 6 months appeared to be beneficial in improving global cognitive function of older people with MCI. Consuming Tempeh A, which had a lower number of microorganisms, was also associated with an improvement in the language domain.",2020,"Consuming Tempeh A, which had a lower number of microorganisms, was also associated with an improvement in the language domain.","['older people with MCI', '90 respondents', 'Mild Cognitive Impairment', 'older people', '84 subjects at the end of the study, majority being female (71.4%) and aged over 65 years (72.6', 'Respondents with diabetes were excluded', 'The inclusion criteria were respondents aged 60 years or over with mild cognitive impairment (MCI) who agreed not to consume other fermented food during the study period']",[],"['global cognitive scores', 'global cognitive function', 'Blood uric acid level', 'language domain scores']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0016452', 'cui_str': 'Foods'}]",[],"[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0373739', 'cui_str': 'Blood uric acid'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}]",,0.0226059,"Consuming Tempeh A, which had a lower number of microorganisms, was also associated with an improvement in the language domain.","[{'ForeName': 'Yvonne Suzy', 'Initials': 'YS', 'LastName': 'Handajani', 'Affiliation': 'Center of Health Research, Atma Jaya Catholic University of Indonesia, Jakarta, Indonesia.'}, {'ForeName': 'Yuda', 'Initials': 'Y', 'LastName': 'Turana', 'Affiliation': 'Department of Neurology, School of Medicine and Health Sciences, Atma Jaya Catholic University of Indonesia, Jakarta, Indonesia, yuda.turana@atmajaya.ac.id.'}, {'ForeName': 'Yogiara', 'Initials': 'Y', 'LastName': 'Yogiara', 'Affiliation': 'Faculty of Biotechnology, Atma Jaya Catholic University of Indonesia, Jakarta, Indonesia.'}, {'ForeName': 'Nelly Tina', 'Initials': 'NT', 'LastName': 'Widjaja', 'Affiliation': 'Center of Health Research, Atma Jaya Catholic University of Indonesia, Jakarta, Indonesia.'}, {'ForeName': 'Tara Puspitarini', 'Initials': 'TP', 'LastName': 'Sani', 'Affiliation': 'Department of Neurology, School of Medicine and Health Sciences, Atma Jaya Catholic University of Indonesia, Jakarta, Indonesia.'}, {'ForeName': 'Geovannie Audrey Moniqe', 'Initials': 'GAM', 'LastName': 'Christianto', 'Affiliation': 'Faculty of Biotechnology, Atma Jaya Catholic University of Indonesia, Jakarta, Indonesia.'}, {'ForeName': 'Antonius', 'Initials': 'A', 'LastName': 'Suwanto', 'Affiliation': 'Faculty of Biotechnology, Atma Jaya Catholic University of Indonesia, Jakarta, Indonesia.'}]",Dementia and geriatric cognitive disorders,['10.1159/000510563']
1703,33080623,Isatuximab as monotherapy and combined with dexamethasone in patients with relapsed/refractory multiple myeloma.,"This Phase 2 study evaluated isatuximab as monotherapy or combined with dexamethasone in relapsed/refractory multiple myeloma (RRMM). Patients had RRMM refractory to an immunomodulatory drug (IMiD) and a proteasome inhibitor (PI) or had received ≥3 prior lines of therapy incorporating an IMiD and PI. Patients received isatuximab either as monotherapy (20 mg/kg on days 1, 8, 15, and 22 [once weekly] of cycle 1 followed by 20 mg/kg on days 1 and 15 of subsequent cycles; Isa group) or in combination with dexamethasone (40 mg/day [20 mg/day in patients ≥75 years] once weekly; Isa-dex group). Treated patients (N = 164) had received a median of 4 (range, 2-10) prior treatment lines. Patients received a median of 5 (1-24) and 7 (1-22) treatment cycles; at data cut-off, 13/109 (11.9%) and 15/55 (27.3%) patients remained on treatment in the Isa and Isa-dex arms, respectively. Overall response rate (primary efficacy endpoint) was 23.9% in the Isa arm and 43.6% in the Isa-dex arm (odds ratio, 0.405; 95% confidence interval, 0.192-0.859, P = 0.008). Median progression-free survival and overall survival were 4.9 and 18.9 months for Isa, and 10.2 and 17.3 months for Isa-dex. Infusion reactions (mostly grade 1/2) and hematologic abnormalities were the most common adverse events. There was a similar incidence of grade ≥3 infections in both groups (22.0% and 21.8%). In conclusion, addition of dexamethasone to isatuximab increased response rates and survival outcomes with no detrimental effect on safety. This trial was registered at www.clinicaltrials.gov as NCT01084252.",2020,There was a similar incidence of grade ≥3 infections in both groups (22.0% and 21.8%).,"['Patients had RRMM refractory to an immunomodulatory drug (IMiD) and a proteasome inhibitor (PI) or had received ≥3 prior lines of therapy incorporating an IMiD and PI', 'patients with relapsed/refractory multiple myeloma', 'relapsed/refractory multiple myeloma (RRMM']","['dexamethasone', 'isatuximab either as monotherapy']","['Overall response rate', 'Median progression-free survival and overall survival', 'grade ≥3 infections', 'response rates and survival outcomes', 'hematologic abnormalities']","[{'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1443643', 'cui_str': 'Proteasome inhibitor'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C4551538', 'cui_str': 'Plasma cell myeloma refractory'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C4330502', 'cui_str': 'isatuximab'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0018943', 'cui_str': 'Hematology'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}]",164.0,0.190506,There was a similar incidence of grade ≥3 infections in both groups (22.0% and 21.8%).,"[{'ForeName': 'Meletios A', 'Initials': 'MA', 'LastName': 'Dimopoulos', 'Affiliation': 'National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Bringhen', 'Affiliation': 'University of Torino, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Torino, Italy.'}, {'ForeName': 'Pekka M', 'Initials': 'PM', 'LastName': 'Anttila', 'Affiliation': 'Helsinki University and Helsinki University Hospital, Helksinki, Finland.'}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Capra', 'Affiliation': 'Hospital Mãe de Deus, Porto Alegre, Brazil.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Cavo', 'Affiliation': 'Seràgnoli Institute of Hematology, Bologna, Italy.'}, {'ForeName': 'Craig Emmitt', 'Initials': 'CE', 'LastName': 'Cole', 'Affiliation': 'Michigan State University, East Lansing, Michigan, United States.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Gasparetto', 'Affiliation': 'Duke University.'}, {'ForeName': 'Vania Tietsche de Moraes', 'Initials': 'VTM', 'LastName': 'Hungria', 'Affiliation': 'Clinica Sao Germano, São Paulo, Brazil.'}, {'ForeName': 'Matthew W', 'Initials': 'MW', 'LastName': 'Jenner', 'Affiliation': 'University Hospital Southampton, Southampton, United Kingdom.'}, {'ForeName': 'Vladimir I', 'Initials': 'VI', 'LastName': 'Vorobyev', 'Affiliation': 'S.P. Botkin Hospital, Moscow, Russian Federation.'}, {'ForeName': 'Eduardo Patricio', 'Initials': 'EP', 'LastName': 'Yanez Ruiz', 'Affiliation': 'Universidad de la Frontera, Temuco, Chile.'}, {'ForeName': 'Jian Y', 'Initials': 'JY', 'LastName': 'Yin', 'Affiliation': 'Sanofi, Bridgewater, New Jersey, United States.'}, {'ForeName': 'Rao', 'Initials': 'R', 'LastName': 'Saleem', 'Affiliation': 'Sanofi, Bridgewater, New Jersey, United States.'}, {'ForeName': 'Maeva', 'Initials': 'M', 'LastName': 'Hellet', 'Affiliation': 'Ividata (for Sanofi), Paris, France.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Macé', 'Affiliation': 'Sanofi, Paris, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Paiva', 'Affiliation': 'Clinica Universidad de Navarra, Pamplona, Spain.'}, {'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Vij', 'Affiliation': 'Washington University, St Louis, Missouri, United States.'}]",Blood,['10.1182/blood.2020008209']
1704,33080693,The long-term effect of acupuncture for patients with knee osteoarthritis: Study protocol for a randomized controlled trial.,"INTRODUCTION


Whether there is the long-term effect of acupuncture on patients with knee osteoarthritis (KOA) or not is controversial. According to the basic theory of traditional acupuncture, deqi is the key to the efficacy of acupuncture. This randomized controlled trial aims to evaluate the existence of long-term effects caused by deqi in patients with KOA.
METHODS AND ANALYSIS


A three-armed, parallel-design, randomized controlled trial is underway in China.108 KOA patients recruited by the rehabilitation center of the First Affiliated Hospital of Henan University of Traditional Chinese Medicine will be randomly assigned to the acupuncture with deqi group (A group), the acupuncture without deqi group (B group) and the waiting-list group (C group). Each patient will receive 5 30-minute sessions per week for 4 consecutive weeks and rest for 2 days between treatments, and undergo a 20-week follow-up. The primary outcome is the Western Ontario and McMaster Universities Osteoarthritis index (WOMAC score). The secondary outcomes include Western Ontario and McMaster Universities Osteoarthritis index (WOMAC score), Knee Injury and Osteoarthritis Outcome Score (KOOS), arthritis quality of life measurement scale simplified scale (AIMS2-SF), emotional monitoring and expectation scale. The pain visual analogue scale (VAS) and the Chinese version of modified Massachusetts General Hospital Acupuncture Sensation Scale (C-MMASS) will be used to evaluate the deqi sensation after each acupuncture treatment. At the same time, adverse events (AEs) occurred in the whole process will be recorded and analyzed. We will perform an intention-to-treat analysis and protocol (PP) analysis to statistically analyze the results of the trial.
DISCUSSION


This trial will be useful to study the long-term effect of acupuncture and the influence of the deqi sensation on the long-term in the treatment of KOA, and to provide a clinical basis for treatment of patients with mild to moderate knee osteoarthritis in clinic.
TRIAL REGISTRATION


Chinese Clinical Trial Registry, IDF: ChiCTR2000029291. Registered on January 21, 2020.",2020,The pain visual analogue scale (VAS) and the Chinese version of modified Massachusetts General Hospital Acupuncture Sensation Scale (C-MMASS) will be used to evaluate the deqi sensation after each acupuncture treatment.,"['patients with mild to moderate knee osteoarthritis in clinic', 'patients with KOA', 'patients with knee osteoarthritis', 'patients with knee osteoarthritis (KOA', 'China.108 KOA patients recruited by the rehabilitation center of the First Affiliated Hospital of Henan University of Traditional Chinese Medicine']","['acupuncture without deqi group (B group) and the waiting-list group', 'acupuncture with deqi', 'acupuncture']","['pain visual analogue scale (VAS) and the Chinese version of modified Massachusetts General Hospital Acupuncture Sensation Scale (C-MMASS', 'Western Ontario and McMaster Universities Osteoarthritis index (WOMAC score', 'deqi sensation', 'Western Ontario and McMaster Universities Osteoarthritis index (WOMAC score), Knee Injury and Osteoarthritis Outcome Score (KOOS), arthritis quality of life measurement scale simplified scale (AIMS2-SF), emotional monitoring and expectation scale', 'adverse events (AEs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0034993', 'cui_str': 'Centers, Rehabilitation'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0024874', 'cui_str': 'Massachusetts'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3476088', 'cui_str': 'Knee Injury and Osteoarthritis Outcome Score'}, {'cui': 'C0003864', 'cui_str': 'Arthritis'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0681887', 'cui_str': 'Measurement scales'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.114547,The pain visual analogue scale (VAS) and the Chinese version of modified Massachusetts General Hospital Acupuncture Sensation Scale (C-MMASS) will be used to evaluate the deqi sensation after each acupuncture treatment.,"[{'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Wu', 'Affiliation': 'School of Rehabilitation Medicine, Henan University of Chinese Medicine.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'School of Rehabilitation Medicine, Henan University of Chinese Medicine.'}, {'ForeName': 'Xuguang', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'School of Rehabilitation Medicine, Henan University of Chinese Medicine.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': 'The Rehabilitation Center, First Affiliated Hospital of Henan University of Chinese Medicine.'}, {'ForeName': 'Feilai', 'Initials': 'F', 'LastName': 'Liu', 'Affiliation': 'The Rehabilitation Center, First Affiliated Hospital of Henan University of Chinese Medicine.'}, {'ForeName': 'Yujing', 'Initials': 'Y', 'LastName': 'Gu', 'Affiliation': 'The Rehabilitation Center, First Affiliated Hospital of Henan University of Chinese Medicine.'}, {'ForeName': 'Yongtao', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'The Rehabilitation Center, First Affiliated Hospital of Henan University of Chinese Medicine.'}, {'ForeName': 'Zhenhua', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'School of Rehabilitation Medicine, Henan University of Chinese Medicine.'}, {'ForeName': 'Shuai', 'Initials': 'S', 'LastName': 'Yin', 'Affiliation': 'The Rehabilitation Center, First Affiliated Hospital of Henan University of Chinese Medicine.'}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Feng', 'Affiliation': 'The Rehabilitation Center, First Affiliated Hospital of Henan University of Chinese Medicine.'}]",Medicine,['10.1097/MD.0000000000022599']
1705,33080728,Uniportal versus multiportal thoracoscopic lobectomy: Ergonomic evaluation and perioperative outcomes from a randomized and controlled trial.,"BACKGROUND


To compare perioperative outcomes and surgeon physical and mental stress when performing lobectomy through uniportal and multiportal video-assisted thoracoscopic surgery (VATS) on patients with non-small-cell lung cancer (NSCLC).
METHODS


Patients aged 41 to 73 years with resectable NSCLC were randomly assigned via a computer-generated randomisation sequence to receive either uniportal VATS (UVATS) or multiportal VATS (MVATS) lobectomy and lymphadenectomy between December 2015 and October 2016. Overall, we randomly assigned 35 patients to the UVATS and 34 to the MVATS group. Patients and the investigators undertaking interventions, assessing short-term outcomes, performing ergonomic evaluations, and analyzing data were not masked to group assignment.
RESULTS


Patient demographics of the 2 groups were comparable. The ergonomic evaluation considered eye blink rate and the NASA Task Load Index (NASA-TLX), better results were observed in UVATS than in MVATS. The operative time, number of lymph nodes harvested, chest tube duration, length of hospital stay, and lung function were not significantly different between the groups. Compared with MVATS lobectomy, UVATS lobectomy was associated with less intraoperative blood loss and less volume of total drainage in the 24 hours. No conversion, no reoperation, and no in-hospital mortality occurred in either group.
CONCLUSIONS


UVATS lobectomy is a safe and programmable technique with some better perioperative outcomes and ergonomic results than MVATS. Further studies based on large numbers of patients and with long-term follow-up are required to confirm its benefits towards patients.
TRIAL REGISTRATION


ClinicalTrials.gov ID:NCT02462356. Registered May 27, 2015.",2020,"Compared with MVATS lobectomy, UVATS lobectomy was associated with less intraoperative blood loss and less volume of total drainage in the 24 hours.","['Patients aged 41 to 73 years with resectable NSCLC', 'patients with non-small-cell lung cancer (NSCLC']","['uniportal VATS (UVATS) or multiportal VATS (MVATS) lobectomy and lymphadenectomy', 'MVATS lobectomy, UVATS lobectomy', 'lobectomy through uniportal and multiportal video-assisted thoracoscopic surgery (VATS', 'Uniportal versus multiportal thoracoscopic lobectomy', 'UVATS lobectomy']","['eye blink rate and the NASA Task Load Index (NASA-TLX', 'hospital mortality', 'intraoperative blood loss and less volume of total drainage', 'operative time, number of lymph nodes harvested, chest tube duration, length of hospital stay, and lung function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}]","[{'cui': 'C4304660', 'cui_str': 'Uniportal VATS - video assisted thoracoscopic surgery'}, {'cui': 'C0042427', 'cui_str': 'Vatican City'}, {'cui': 'C0752151', 'cui_str': 'Surgery, Thoracic, Video-Assisted'}, {'cui': 'C0023928', 'cui_str': 'Lobectomy'}, {'cui': 'C0024203', 'cui_str': 'Excision of lymph node'}]","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0005757', 'cui_str': 'Blinking'}, {'cui': 'C0242776', 'cui_str': 'National Aeronautics and Space Administration'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}, {'cui': 'C0008034', 'cui_str': 'Chest drain'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}]",35.0,0.0965214,"Compared with MVATS lobectomy, UVATS lobectomy was associated with less intraoperative blood loss and less volume of total drainage in the 24 hours.","[{'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Yao', 'Affiliation': 'Department of Thoracic Surgery, Second Affiliated Hospital of Zhejiang University, School of Medicine, Hangzhou, China.'}, {'ForeName': 'Zhibo', 'Initials': 'Z', 'LastName': 'Chang', 'Affiliation': ''}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': ''}, {'ForeName': 'Junqiang', 'Initials': 'J', 'LastName': 'Fan', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000022719']
1706,33080730,Effects of positive dispatcher encouragement on the maintenance of bystander cardiopulmonary resuscitation quality.,"BACKGROUND


Implementation of dispatcher-assisted cardiopulmonary resuscitation (DACPR) has increased the likelihood of bystander CPR upon cardiac arrest. However, the quality of CPR has been found to be very low. In this study, we aimed to compare CPR quality between the current DACPR practices and the interventional instruction of adding verbal encouragement from the dispatcher.
METHODS


In this randomized controlled trial, we recruited adult (age ≥18) laypersons who were non-health care providers and had never received any previous verified CPR training. They were randomly selected to perform DACPR using metronome sounds (mDACPR) as per the standard protocol, or DACPR with metronome sounds along with human encouragement (mheDACPR). The ratio of accurate compression rate, depth, and complete release for each CPR phase was examined.
RESULTS


Sixty nine records (34, mDACPR; 35, mheDACPR) were taken. The median proportion of accurate chest compression rate was initially 29.5% with mDACPR, and significantly increased to 71% after 2 minutes of CPR administration (P = .046). However, the median ratio of accurate chest compression depth was 61.5% in the first phase, and significantly decreased to 0% in the last phase (P < .001). In contrast, for the mheDACPR group, a high accurate compression rate was maintained throughout the 2 minutes of CPR administration (91%, 100%, 100%, 100%).
CONCLUSION


To maintain the quality of CPR administered by bystanders, continuous feedback and repeated human encouragement should be provided during DACPR. Active dispatcher intervention reduces the time required to reach an appropriate CPR rate and allows for the maintenance of accurate compression rates.",2020,Active dispatcher intervention reduces the time required to reach an appropriate CPR rate and allows for the maintenance of accurate compression rates.,['recruited adult (age ≥18) laypersons who were non-health care providers and had never received any previous verified CPR training'],"['dispatcher-assisted cardiopulmonary resuscitation (DACPR', 'DACPR using metronome sounds (mDACPR) as per the standard protocol, or DACPR with metronome sounds along with human encouragement (mheDACPR', 'positive dispatcher encouragement', 'Active dispatcher intervention']","['accurate compression rate', 'median proportion of accurate chest compression rate', 'median ratio of accurate chest compression depth', 'bystander cardiopulmonary resuscitation quality', 'ratio of accurate compression rate, depth, and complete release', 'time required to reach an appropriate CPR rate', 'CPR quality']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0037709', 'cui_str': 'Sonic Radiation'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}]",,0.0236743,Active dispatcher intervention reduces the time required to reach an appropriate CPR rate and allows for the maintenance of accurate compression rates.,"[{'ForeName': 'Bo Na', 'Initials': 'BN', 'LastName': 'Hwang', 'Affiliation': 'Emergency Medicine Research Foundation, Seoul.'}, {'ForeName': 'Eun Hae', 'Initials': 'EH', 'LastName': 'Lee', 'Affiliation': 'Department of Emergency Medicine, Hallym University Dongtan Sacred Heart Hospital, Hwaseong-si, Gyeonggi-do, Korea.'}, {'ForeName': 'Hang A', 'Initials': 'HA', 'LastName': 'Park', 'Affiliation': 'Department of Emergency Medicine, Hallym University Dongtan Sacred Heart Hospital, Hwaseong-si, Gyeonggi-do, Korea.'}, {'ForeName': 'Ju Ok', 'Initials': 'JO', 'LastName': 'Park', 'Affiliation': 'Department of Emergency Medicine, Hallym University Dongtan Sacred Heart Hospital, Hwaseong-si, Gyeonggi-do, Korea.'}, {'ForeName': 'Choung Ah', 'Initials': 'CA', 'LastName': 'Lee', 'Affiliation': 'Department of Emergency Medicine, Hallym University Dongtan Sacred Heart Hospital, Hwaseong-si, Gyeonggi-do, Korea.'}]",Medicine,['10.1097/MD.0000000000022728']
1707,33080734,Will purposely seeking detect more colorectal polyps than routine performing during colonoscopy?,"BACKGROUND & GOALS


We observed that the number of colorectal polyps found intraoperatively was often higher than that encountered preoperatively during elective colonoscopic polypectomy. To evaluate whether more polyps can be detected when they are purposely sought than when they are routinely examined during colonoscopy.
MATERIALS AND METHODS


Patients undergoing colonoscopy were randomized into groups A and B. Before colonoscopy was performed, endoscopists were instructed to seek polyps for group A purposely but not for group B. Polypectomy was electively completed. In groups A and B, the cases of elective polypectomy were named groups AR and BR, including groups AR-1 and BR-1, during the first colonoscopy and groups AR-2 and BR-2 during the second colonoscopy for polypectomy, respectively. The following data were calculated: the number of polyps detected (NPD) and the polyp detection rate (PDR) in all cases and the number of polyps missed (NPM) and partial polyp miss rate (PPMR) in the cases of colorectal polyps.
RESULTS


A total of 419 cases were included in group A, 421 in group B, 43 in group AR, and 35 in group BR. No significant differences in PDR were found between groups A and B and in PPMR between groups AR-1 and BR-1 (P > .05), although PPMR in group AR-1 was higher than in group AR-2 (P < .05), similar results were found in PPMR between groups BR-1 and BR-2 (P < .05).
CONCLUSION


Purposely seeking for colorectal polyps did not result in more polyps detected compared with routine colonoscopy.",2020,"No significant differences in PDR were found between groups A and B and in PPMR between groups AR-1 and BR-1 (P > .05), although PPMR in group AR-1 was higher than in group AR-2 (P < .05), similar results were found in PPMR between groups BR-1 and BR-2 (P < .05).
","['Patients undergoing colonoscopy', 'A total of 419 cases were included in group A, 421 in group B, 43 in group AR, and 35 in group BR']",[],"['PPMR in group AR-1', 'number of polyps missed (NPM) and partial polyp miss rate (PPMR', 'number of polyps detected (NPD) and the polyp detection rate (PDR', 'PDR', 'PPMR between groups BR-1 and BR-2']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]",[],"[{'cui': 'C0032584', 'cui_str': 'Polyp'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0103931', 'cui_str': 'AR-1'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}]",419.0,0.0195262,"No significant differences in PDR were found between groups A and B and in PPMR between groups AR-1 and BR-1 (P > .05), although PPMR in group AR-1 was higher than in group AR-2 (P < .05), similar results were found in PPMR between groups BR-1 and BR-2 (P < .05).
","[{'ForeName': 'Yanliu', 'Initials': 'Y', 'LastName': 'Chu', 'Affiliation': 'Department of Hepatology and Gastroenterology, Chinese PLA General Hospital, Beijing.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Gastroenterology, Weihai Municipal Hospital, Cheeloo College of Medicine, Shandong University, Weihai, Shandong Province, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Wang', 'Affiliation': 'Department of Gastroenterology, Weihai Municipal Hospital, Cheeloo College of Medicine, Shandong University, Weihai, Shandong Province, China.'}, {'ForeName': 'Tian', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'Department of Gastroenterology, Weihai Municipal Hospital, Cheeloo College of Medicine, Shandong University, Weihai, Shandong Province, China.'}, {'ForeName': 'Shuyi', 'Initials': 'S', 'LastName': 'Jiang', 'Affiliation': 'Department of Gastroenterology, Weihai Municipal Hospital, Cheeloo College of Medicine, Shandong University, Weihai, Shandong Province, China.'}, {'ForeName': 'Qinfu', 'Initials': 'Q', 'LastName': 'Zhao', 'Affiliation': 'Department of Gastroenterology, Weihai Municipal Hospital, Cheeloo College of Medicine, Shandong University, Weihai, Shandong Province, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Liu', 'Affiliation': 'Department of Gastroenterology, Weihai Municipal Hospital, Cheeloo College of Medicine, Shandong University, Weihai, Shandong Province, China.'}, {'ForeName': 'Xiaozhong', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': 'Department of Gastroenterology, Weihai Municipal Hospital, Cheeloo College of Medicine, Shandong University, Weihai, Shandong Province, China.'}, {'ForeName': 'Xiuli', 'Initials': 'X', 'LastName': 'Qiao', 'Affiliation': 'Department of Gastroenterology, Weihai Municipal Hospital, Cheeloo College of Medicine, Shandong University, Weihai, Shandong Province, China.'}, {'ForeName': 'Xiaofeng', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Gastroenterology, Weihai Municipal Hospital, Cheeloo College of Medicine, Shandong University, Weihai, Shandong Province, China.'}, {'ForeName': 'Zhenhe', 'Initials': 'Z', 'LastName': 'Song', 'Affiliation': 'Department of Gastroenterology, Weihai Municipal Hospital, Cheeloo College of Medicine, Shandong University, Weihai, Shandong Province, China.'}, {'ForeName': 'Heye', 'Initials': 'H', 'LastName': 'Liang', 'Affiliation': 'Department of Gastroenterology, Weihai Municipal Hospital, Cheeloo College of Medicine, Shandong University, Weihai, Shandong Province, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Yue', 'Affiliation': 'Department of Gastroenterology, Weihai Municipal Hospital, Cheeloo College of Medicine, Shandong University, Weihai, Shandong Province, China.'}, {'ForeName': 'Enqiang', 'Initials': 'E', 'LastName': 'Linghu', 'Affiliation': 'Department of Hepatology and Gastroenterology, Chinese PLA General Hospital, Beijing.'}]",Medicine,['10.1097/MD.0000000000022738']
1708,33080740,The effect of preoperative intravenous lidocaine on postoperative pain following hysteroscopy: A randomized controlled trial.,"BACKGROUND


The use of hysteroscopy for the diagnosis and treatment of uterine and endometrial abnormalities is often associated with postoperative pain. This randomized controlled trial aimed to assess the efficacy of preoperative intravenous (IV) lidocaine in reducing pain after hysteroscopy.
METHODS


In total, 138 patients undergoing elective hysteroscopy at the CHA Bundang Medical Center, Seongnam, Korea were randomly assigned to a control group (n = 69) or a lidocaine group (n = 69), which received normal saline or IV lidocaine at 1.5 mg/kg, respectively. The primary outcome was the incidence of postoperative pain.
RESULTS


The incidence of pain was significantly lower in the IV lidocaine group than in the control group at the post-anesthesia care unit (27.3% vs 68.2%, P < .001). The visual analog scale (0-10) score (median [interquartile range]) was lower in the IV lidocaine group than in the control group (0 [0-2]) vs 2 [0-4]), P < .001). The use of rescue analgesics and postoperative nausea and vomiting were similar between the 2 groups. This study demonstrated that administering 1.5 mg/kg of preoperative IV lidocaine can be a simple method to reduce incidence of pain after hysteroscopy.
CONCLUSION


Preoperative bolus administration of 1.5 mg/kg of IV lidocaine may be used to decrease incidence of pain after hysteroscopy under general anesthesia.",2020,"The incidence of pain was significantly lower in the IV lidocaine group than in the control group at the post-anesthesia care unit (27.3% vs 68.2%, P < .001).","['following hysteroscopy', '138 patients undergoing elective hysteroscopy at the CHA Bundang Medical Center, Seongnam, Korea']","['normal saline or IV lidocaine', 'preoperative intravenous (IV) lidocaine', 'lidocaine']","['visual analog scale', 'postoperative nausea and vomiting', 'incidence of pain', 'incidence of postoperative pain', 'postoperative pain', 'pain']","[{'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0020710', 'cui_str': 'Hysteroscopy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0574369', 'cui_str': 'Chamorro language'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0022771', 'cui_str': 'Korea'}]","[{'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}]",138.0,0.190699,"The incidence of pain was significantly lower in the IV lidocaine group than in the control group at the post-anesthesia care unit (27.3% vs 68.2%, P < .001).","[{'ForeName': 'Jiyoung', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, CHA Bundang Medical Center, CHA University, Seongnam.'}, {'ForeName': 'Seunghoon', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, CHA Bundang Medical Center, CHA University, Seongnam.'}, {'ForeName': 'Heungwoo', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, CHA Bundang Medical Center, CHA University, Seongnam.'}, {'ForeName': 'Hyeon Chul', 'Initials': 'HC', 'LastName': 'Kim', 'Affiliation': 'Department of Obstetrics and Gynecology, CHA Bundang Medical Center, CHA University, Seongnam.'}, {'ForeName': 'Chunghyun', 'Initials': 'C', 'LastName': 'Park', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, CHA Bundang Medical Center, CHA University, Seongnam.'}, {'ForeName': 'Jong Yeop', 'Initials': 'JY', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine, Suwon, Korea.'}]",Medicine,['10.1097/MD.0000000000022751']
1709,33080746,Neuromuscular electrical stimulation in early rehabilitation of patients with postoperative complications after cardiovascular surgery: A randomized controlled trial.,"BACKGROUND


To evaluate the effectiveness of neuromuscular electrical stimulation (NMES) in early rehabilitation of patients with postoperative complications after cardiovascular surgery.
METHODS


37 patients (25 men and 12 women) aged 45 to 70 years with postoperative complications after cardiovascular surgery were included in the study. Eighteen patients underwent NMES daily since postoperative day 3 until discharge in addition to standard rehabilitation program (NMES group), and 19 patients underwent standard rehabilitation program only (non-NMES group). The primary outcome was the knee extensors strength at discharge in NMES group and in control. Secondary outcomes were the handgrip strength, knee flexor strength, and cross-sectional area (CSA) of the quadriceps femoris in groups at discharge.
RESULTS


Baseline characteristics were not different between the groups. Knee extensors strength at discharge was significantly higher in the NMES group (28.1 [23.8; 36.2] kg on the right and 27.45 [22.3; 33.1] kg on the left) than in the non-NMES group (22.3 [20.1; 27.1] and 22.5 [20.1; 25.9] kg, respectively; P < .001). Handgrip strength, knee flexor strength, quadriceps CSA, and 6 minute walk distance at discharge in the groups had no significant difference.
CONCLUSIONS


This pilot study shows a beneficial effect of NMES on muscle strength in patients with complications after cardiovascular surgery. The use of NMES showed no effect on strength of non-stimulated muscle, quadriceps CSA, and distance of 6-minute walk test at discharge.Further blind randomized controlled trials should be performed with emphasis on the effectiveness of NEMS in increasing muscle strength and structure in these patients.",2020,Knee extensors strength at discharge was significantly higher in the NMES group (28.1 [23.8; 36.2] kg on the right and 27.45,"['37 patients (25 men and 12 women) aged 45 to 70 years with postoperative complications after cardiovascular surgery were included in the study', 'Eighteen patients underwent NMES daily since postoperative day 3 until discharge in addition to standard rehabilitation program (NMES group), and 19 patients underwent', 'patients with complications after cardiovascular surgery', 'patients with postoperative complications after cardiovascular surgery']","['NMES', 'Neuromuscular electrical stimulation', 'neuromuscular electrical stimulation (NMES', 'NEMS', 'standard rehabilitation program']","['handgrip strength, knee flexor strength, and cross-sectional area (CSA) of the quadriceps femoris in groups at discharge', 'muscle strength', 'Knee extensors strength at discharge', 'strength of non-stimulated muscle, quadriceps CSA, and distance of 6-minute walk test at discharge', 'Handgrip strength, knee flexor strength, quadriceps CSA, and 6 minute walk distance at discharge', 'knee extensors strength at discharge']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0038897', 'cui_str': 'Cardiovascular surgical procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]","[{'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}]","[{'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3871203', 'cui_str': 'At discharge'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}]",18.0,0.182019,Knee extensors strength at discharge was significantly higher in the NMES group (28.1 [23.8; 36.2] kg on the right and 27.45,"[{'ForeName': 'Alexey Nikolaevich', 'Initials': 'AN', 'LastName': 'Sumin', 'Affiliation': ''}, {'ForeName': 'Pavel Alexandrovich', 'Initials': 'PA', 'LastName': 'Oleinik', 'Affiliation': ''}, {'ForeName': 'Andrey Viktorovich', 'Initials': 'AV', 'LastName': 'Bezdenezhnykh', 'Affiliation': ''}, {'ForeName': 'Anna Valeryvena', 'Initials': 'AV', 'LastName': 'Ivanova', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000022769']
1710,33080765,Effects of Thrower's Ten exercises on upper extremity performance: A randomized controlled study.,"OBJECTIVES


The Thrower's Ten Exercise program is an exercise program especially designed to improve the strength, power and endurance of the shoulder complex. The aim of this study was to investigate the effects of the Thrower's Ten exercises on the upper extremity performance in healthy sedentary individuals.
METHODS


36 healthy sedentary individuals completed this study conducted with a randomized controlled design. The subjects were divided into 2 groups: exercise and control. The exercise group received a training of the Thrower's Ten exercises of 50-minute sessions 3 times a week for a duration of 8 weeks. Before and after the study, the subjects were tested for dynamic balance on the upper extremity with the Upper Limp Y balance test and for explosive power with the medicine ball throw test. Moreover, the strength of the shoulder internal and external rotator muscles was measured with an isokinetic dynamometer at a speed of 60°/second. The study was registered on the Clinical Trials website by the number NCT04162886.
RESULTS


A comparison between the groups showed significant differences in terms of dynamic balance and explosive power (P < .05), but not in terms of isokinetic muscle strength and body composition (P > .05). On the other hand, comparisons of the dynamic equilibrium, explosive power and isokinetic muscle strength parameters within the exercise group returned statistically different results (P < .05).
CONCLUSIONS


The Thrower's Ten exercises represent an effective method to improve the balance on the upper extremity, explosive power and isokinetic strength in healthy sedentary individuals.",2020,"A comparison between the groups showed significant differences in terms of dynamic balance and explosive power (P < .05), but not in terms of isokinetic muscle strength and body composition (P > .05).","['healthy sedentary individuals', '36 healthy sedentary individuals']",['exercise and control'],"['dynamic balance and explosive power', 'dynamic equilibrium, explosive power and isokinetic muscle strength parameters', 'upper extremity performance', 'strength of the shoulder internal and external rotator muscles', 'isokinetic muscle strength and body composition']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0015330', 'cui_str': 'Explosive device'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0224320', 'cui_str': 'Structure of rotator muscle'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}]",36.0,0.0170843,"A comparison between the groups showed significant differences in terms of dynamic balance and explosive power (P < .05), but not in terms of isokinetic muscle strength and body composition (P > .05).","[{'ForeName': 'Ozge', 'Initials': 'O', 'LastName': 'Gokalp', 'Affiliation': 'Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Eastern Mediterranean University, Famagusta, North Cyprus, 99628, via Mersin-10, Turkey.'}, {'ForeName': 'Berkiye', 'Initials': 'B', 'LastName': 'Kirmizigil', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000022837']
1711,33080806,Rehabilitation Improves Mitochondrial Energetics in Progressive Multiple Sclerosis: The Significant Role of Robot-Assisted Gait Training and of the Personalized Intensity.,"Abnormal levels of pyruvate and lactate were reported in multiple sclerosis (MS). We studied the response of markers of mitochondrial function to rehabilitation in relation to type, intensity and endurance performance in severely disabled MS patients. Forty-six progressive MS patients were randomized to receive 12 walking sessions of robot-assisted gait training (RAGT,  n  = 23) or conventional overground therapy (CT,  n  = 23). Ten healthy subjects were also studied. Blood samples were collected to determine lactate, pyruvate, and glutathione levels and lactate/pyruvate ratio pre-post rehabilitation. In vivo muscle metabolism and endurance walking capacity were assessed by resting muscle oxygen consumption (rmVO 2 ) using near-infrared spectroscopy and by six-minute walking distance (6MWD), respectively. The levels of mitochondrial biomarkers and rmVO 2 , altered at baseline with respect to healthy subjects, improved after rehabilitation in the whole population. In the two groups, an enhanced response was observed after RAGT compared to CT for lactate ( p  = 0.012), glutathione (<0.001), lactate/pyruvate ratio ( p  = 0.08) and rmVO 2  ( p  = 0.07). Metabolic biomarkers and 6MWD improvements were exclusively correlated with a training speed markedly below individual gait speed. In severely disabled MS patients, rehabilitation rebalanced altered serum metabolic and muscle parameters, with RAGT being more effective than CT. A determinable slow training speed was associated with better metabolic and functional recovery. Trial Registration: ClinicalTrials.gov NCT02421731.",2020,"The levels of mitochondrial biomarkers and rmVO 2 , altered at baseline with respect to healthy subjects, improved after rehabilitation in the whole population.","['Progressive Multiple Sclerosis', 'Ten healthy subjects', 'Forty-six progressive MS patients', 'severely disabled MS patients']","['12 walking sessions of robot-assisted gait training (RAGT,  n  = 23) or conventional overground therapy', 'Robot-Assisted Gait Training', 'Rehabilitation']","['lactate/pyruvate ratio', 'metabolic and functional recovery', 'lactate, pyruvate, and glutathione levels and lactate/pyruvate ratio pre-post rehabilitation', 'Metabolic biomarkers and 6MWD improvements', 'Abnormal levels of pyruvate and lactate', 'enhanced response']","[{'cui': 'C1095979', 'cui_str': 'Progressive multiple sclerosis'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018576', 'cui_str': 'Handicapped'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}]","[{'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C0428617', 'cui_str': 'Lactate/pyruvate ratio measurement'}, {'cui': 'C0599766', 'cui_str': 'Recovery of Function'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0034354', 'cui_str': 'Pyruvates'}, {'cui': 'C0202053', 'cui_str': 'Glutathione measurement'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",10.0,0.0175828,"The levels of mitochondrial biomarkers and rmVO 2 , altered at baseline with respect to healthy subjects, improved after rehabilitation in the whole population.","[{'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Manfredini', 'Affiliation': 'Department of Neuroscience and rehabilitation, University of Ferrara, 44121 Ferrara, Italy.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Straudi', 'Affiliation': 'Department of Neuroscience/Rehabilitation, Unit of Rehabilitation Medicine, University Hospital of Ferrara, 44124 Ferrara, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Lamberti', 'Affiliation': 'Department of Neuroscience and rehabilitation, University of Ferrara, 44121 Ferrara, Italy.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Patergnani', 'Affiliation': 'Department of Medical Sciences, Laboratory for Technologies of Advanced Therapies (LTTA), University of Ferrara, 44121 Ferrara, Italy.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Tisato', 'Affiliation': 'Department of Morphology, Surgery and Experimental Medicine and LTTA Centre, University of Ferrara, 44121 Ferrara, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Secchiero', 'Affiliation': 'Department of Morphology, Surgery and Experimental Medicine and LTTA Centre, University of Ferrara, 44121 Ferrara, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Bernardi', 'Affiliation': 'Department of Life Sciences and Biotechnology, University of Ferrara, 44121 Ferrara, Italy.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Ziliotto', 'Affiliation': 'School of Medicine and Surgery, University of Milano-Bicocca, 20900 Monza, Italy.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Marchetti', 'Affiliation': 'Department of Neuroscience and rehabilitation, University of Ferrara, 44121 Ferrara, Italy.'}, {'ForeName': 'Nino', 'Initials': 'N', 'LastName': 'Basaglia', 'Affiliation': 'Department of Neuroscience/Rehabilitation, Unit of Rehabilitation Medicine, University Hospital of Ferrara, 44124 Ferrara, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Bonora', 'Affiliation': 'Department of Medical Sciences, Laboratory for Technologies of Advanced Therapies (LTTA), University of Ferrara, 44121 Ferrara, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Pinton', 'Affiliation': 'Department of Medical Sciences, Laboratory for Technologies of Advanced Therapies (LTTA), University of Ferrara, 44121 Ferrara, Italy.'}]","Diagnostics (Basel, Switzerland)",['10.3390/diagnostics10100834']
1712,33080817,Novel Resistance Training Approach to Monitoring the Volume in Older Adults: The Role of Movement Velocity.,"We analyzed the effects of velocity-monitored resistance training (RT) with a velocity loss of 20% on strength and functional capacity in institutionalized older adults. Thirty-nine participants (78.8 ± 6.7 years) were divided into a control group (CG;  n  = 20) or an RT group ( n  = 19). Over 10 weeks, the RT group performed two sessions per week, and the mean velocity of each repetition was monitored in the leg-press and chest-press exercises at 40-65% of one-repetition maximum (1RM). The set ended when the participants reached a velocity loss of 20%. The CG maintained their daily routine. At pre- and post-test, both groups were assessed in the 1RM leg-press, 1RM chest-press, handgrip strength, medicine ball throw (MBT), walking speed, and sit-to-stand (STS). At baseline, we did not find significant differences between groups. After 10 weeks, we observed significant differences ( p  < 0.001-0.01) between groups in the 1RM leg-press, 1RM chest-press, MBT-1 kg, and STS. The RT group performed a total number of repetitions of 437.6 ± 66.1 in the leg-press and 296.4 ± 78.9 in the chest-press. Our results demonstrate that velocity loss effectively prescribes the volume in older adults and that a threshold of 20% improves strength-related variables in this population.",2020,"After 10 weeks, we observed significant differences ( p  < 0.001-0.01) between groups in the 1RM leg-press, 1RM chest-press, MBT-1 kg, and STS.","['older adults', 'Thirty-nine participants (78.8 ± 6.7 years', 'institutionalized older adults', 'Older Adults']","['velocity-monitored resistance training (RT', 'Novel Resistance Training Approach']","['velocity loss', '1RM leg-press, 1RM chest-press, handgrip strength, medicine ball throw (MBT), walking speed, and sit-to-stand (STS', 'mean velocity of each repetition']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C3816447', 'cui_str': '39'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0562359', 'cui_str': 'Institutionalized'}]","[{'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0039597', 'cui_str': 'Testis structure'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}]",39.0,0.0241822,"After 10 weeks, we observed significant differences ( p  < 0.001-0.01) between groups in the 1RM leg-press, 1RM chest-press, MBT-1 kg, and STS.","[{'ForeName': 'Diogo L', 'Initials': 'DL', 'LastName': 'Marques', 'Affiliation': 'Department of Sport Sciences, University of Beira Interior, 6201-001 Covilhã, Portugal.'}, {'ForeName': 'Henrique P', 'Initials': 'HP', 'LastName': 'Neiva', 'Affiliation': 'Department of Sport Sciences, University of Beira Interior, 6201-001 Covilhã, Portugal.'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Marinho', 'Affiliation': 'Department of Sport Sciences, University of Beira Interior, 6201-001 Covilhã, Portugal.'}, {'ForeName': 'Mário C', 'Initials': 'MC', 'LastName': 'Marques', 'Affiliation': 'Department of Sport Sciences, University of Beira Interior, 6201-001 Covilhã, Portugal.'}]",International journal of environmental research and public health,['10.3390/ijerph17207557']
1713,33080822,Effect of an Additional 30 Minutes Spent Outdoors during Summer on Daily Steps and Individually Experienced Heat Index.,"Spending time outdoors is associated with increased physical activity; however, high ambient temperature/humidity, together with built environment features in urban versus rural environments, may influence physical activity. We conducted an intervention trial with 89 urban and 88 rural participants performing normal activities on Days 1-2 (baseline) and spending an additional 30 min outdoors on Days 3-7 (intervention) in the summer. Participants wore a pedometer with real-time visual feedback to track daily steps taken and a thermometer clipped to their shoe to track temperatures experienced individually. Hygrometer-thermometers were deployed in participants' neighborhoods to collect finer resolution ambient heat indexes in addition to regional weather station measurements. Using linear mixed effects models and adjusting for ambient conditions and individual-level factors, participants on average walked 637 (95%CI (83, 1192)) more steps and had a 0.59 °C (95%CI (0.30, 0.88)) lower daily mean individually experienced heat index during intervention days compared to baseline days. The intervention benefit of increased physical activity was greater in rural residents who were less active at baseline, compared to urban residents. Our results suggest adding a small amount of additional time outdoors may improve physical activity without increasing participants' heat exposure, even during summer in a humid subtropical climate.",2020,"The intervention benefit of increased physical activity was greater in rural residents who were less active at baseline, compared to urban residents.","['89 urban and 88 rural participants performing normal activities on Days 1-2 (baseline) and spending an additional 30 min outdoors on Days 3-7 (intervention) in the summer', 'rural residents who were less active at baseline, compared to urban residents']",[],['physical activity'],"[{'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",[],"[{'cui': 'C0015259', 'cui_str': 'Exercise'}]",,0.0877572,"The intervention benefit of increased physical activity was greater in rural residents who were less active at baseline, compared to urban residents.","[{'ForeName': 'Suwei', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Translational Biology, Medicine, and Health (TBMH), Virginia Polytechnic Institute and State University, Blacksburg, VA 24061, USA.'}, {'ForeName': 'Molly B', 'Initials': 'MB', 'LastName': 'Richardson', 'Affiliation': 'Department of Medicine, University of Alabama at Birmingham, Birmingham, AL 35205, USA.'}, {'ForeName': 'Connor Y H', 'Initials': 'CYH', 'LastName': 'Wu', 'Affiliation': 'Department of Geospatial Informatics, Troy University, Troy, AL 36082, USA.'}, {'ForeName': 'Benjamin F', 'Initials': 'BF', 'LastName': 'Zaitchik', 'Affiliation': 'Department of Earth and Planetary Sciences, Johns Hopkins University, Baltimore, MD 21218, USA.'}, {'ForeName': 'Julia M', 'Initials': 'JM', 'LastName': 'Gohlke', 'Affiliation': 'Department of Population Health Sciences, Virginia Polytechnic Institute and State University, Blacksburg, VA 24061, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph17207558']
1714,33080839,Vitamin D Status Impacts Genital Mucosal Immunity and Markers of HIV-1 Susceptibility in Women.,"While vitamin D insufficiency is known to impact a multitude of health outcomes, including HIV-1, little is known about the role of vitamin D-mediated immune regulation in the female reproductive tract (FRT). We performed a pilot clinical study of 20 women with circulating 25(OH)D levels <62.5 nmol/L. Participants were randomized into either weekly or daily high-dose oral vitamin D supplementation groups. In addition to serum vitamin D levels, genital mucosal endpoints, including soluble mediators, immune cell populations, gene expression, and ex vivo HIV-1 infection, were assessed. While systemic vitamin D levels showed a significant increase following supplementation, these changes translated into modest effects on the cervicovaginal factors studied. Paradoxically, post-supplementation vitamin D levels were decreased in cervicovaginal fluids. Given the strong correlation between vitamin D status and HIV-1 infection and the widespread nature of vitamin D deficiency, further understanding of the role of vitamin D immunoregulation in the female reproductive tract is important.",2020,"While systemic vitamin D levels showed a significant increase following supplementation, these changes translated into modest effects on the cervicovaginal factors studied.","['Women', '20 women with circulating 25(OH)D levels <62.5 nmol/L. Participants']",['daily high-dose oral vitamin D supplementation'],"['post-supplementation vitamin D levels', 'serum vitamin D levels, genital mucosal endpoints, including soluble mediators, immune cell populations, gene expression, and ex vivo HIV-1 infection', 'Vitamin D Status Impacts Genital Mucosal Immunity and Markers of HIV-1 Susceptibility']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4517836', 'cui_str': '62.5'}, {'cui': 'C0439282', 'cui_str': 'nmol/L'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}]","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0302837', 'cui_str': 'Vitamin supplement agent'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0428586', 'cui_str': 'Serum vitamin D measurement'}, {'cui': 'C0017420', 'cui_str': 'Reproductive System'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C2363741', 'cui_str': 'HIV-1 infection'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0282558', 'cui_str': 'Mucosal Immunity'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}]",20.0,0.15141,"While systemic vitamin D levels showed a significant increase following supplementation, these changes translated into modest effects on the cervicovaginal factors studied.","[{'ForeName': 'Sharon M', 'Initials': 'SM', 'LastName': 'Anderson', 'Affiliation': 'CONRAD, Eastern Virginia Medical School, Norfolk, VA 23507, USA.'}, {'ForeName': 'Andrea R', 'Initials': 'AR', 'LastName': 'Thurman', 'Affiliation': 'CONRAD, Eastern Virginia Medical School, Norfolk, VA 23507, USA.'}, {'ForeName': 'Neelima', 'Initials': 'N', 'LastName': 'Chandra', 'Affiliation': 'CONRAD, Eastern Virginia Medical School, Norfolk, VA 23507, USA.'}, {'ForeName': 'Suzanne S', 'Initials': 'SS', 'LastName': 'Jackson', 'Affiliation': 'CONRAD, Eastern Virginia Medical School, Norfolk, VA 23507, USA.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Asin', 'Affiliation': 'V.A. Medical Center, White River Junction, VT 05009, USA.'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Rollenhagen', 'Affiliation': 'V.A. Medical Center, White River Junction, VT 05009, USA.'}, {'ForeName': 'Mimi', 'Initials': 'M', 'LastName': 'Ghosh', 'Affiliation': 'Milken Institute School of Public Health and Health Services, George Washington University, Washington, DC 20052, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Daniels', 'Affiliation': 'Milken Institute School of Public Health and Health Services, George Washington University, Washington, DC 20052, USA.'}, {'ForeName': 'Nikolas C', 'Initials': 'NC', 'LastName': 'Vann', 'Affiliation': 'CONRAD, Eastern Virginia Medical School, Norfolk, VA 23507, USA.'}, {'ForeName': 'Meredith R', 'Initials': 'MR', 'LastName': 'Clark', 'Affiliation': 'CONRAD, Eastern Virginia Medical School, Norfolk, VA 23507, USA.'}, {'ForeName': 'Gustavo F', 'Initials': 'GF', 'LastName': 'Doncel', 'Affiliation': 'CONRAD, Eastern Virginia Medical School, Norfolk, VA 23507, USA.'}]",Nutrients,['10.3390/nu12103176']
1715,33080845,Wearable Biofeedback Improves Human-Robot Compliance during Ankle-Foot Exoskeleton-Assisted Gait Training: A Pre-Post Controlled Study in Healthy Participants.,"The adjunctive use of biofeedback systems with exoskeletons may accelerate post-stroke gait rehabilitation. Wearable patient-oriented human-robot interaction-based biofeedback is proposed to improve patient-exoskeleton compliance regarding the interaction torque's direction (joint motion strategy) and magnitude (user participation strategy) through auditory and vibrotactile cues during assisted gait training, respectively. Parallel physiotherapist-oriented strategies are also proposed such that physiotherapists can follow in real-time a patient's motor performance towards effective involvement during training. A preliminary pre-post controlled study was conducted with eight healthy participants to conclude about the biofeedback's efficacy during gait training driven by an ankle-foot exoskeleton and guided by a technical person. For the study group, performance related to the interaction torque's direction increased during ( p -value = 0.07) and after ( p -value = 0.07) joint motion training. Further, the performance regarding the interaction torque's magnitude significantly increased during ( p -value = 0.03) and after ( p -value = 68.59×10 -3 ) user participation training. The experimental group and a technical person reported promising usability of the biofeedback and highlighted the importance of the timely cues from physiotherapist-oriented strategies. Less significant improvements in patient-exoskeleton compliance were observed in the control group. The overall findings suggest that the proposed biofeedback was able to improve the participant-exoskeleton compliance by enhancing human-robot interaction; thus, it may be a powerful tool to accelerate post-stroke ankle-foot deformity recovery.",2020,"Further, the performance regarding the interaction torque's magnitude significantly increased during ( p -value = 0.03) and after ( p -value = 68.59×10 -3 ) user participation training.","['eight healthy participants', 'Healthy Participants']","['Wearable Biofeedback Improves Human-Robot Compliance during Ankle-Foot Exoskeleton-Assisted Gait Training', 'gait training driven by an ankle-foot exoskeleton and guided by a technical person']",['patient-exoskeleton compliance'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}]",8.0,0.0170267,"Further, the performance regarding the interaction torque's magnitude significantly increased during ( p -value = 0.03) and after ( p -value = 68.59×10 -3 ) user participation training.","[{'ForeName': 'Cristiana', 'Initials': 'C', 'LastName': 'Pinheiro', 'Affiliation': 'Center for MicroElectroMechanical Systems (CMEMS), Department of Industrial Electronics, School of Engineering, University of Minho, 4800-058 Guimarães, Portugal.'}, {'ForeName': 'Joana', 'Initials': 'J', 'LastName': 'Figueiredo', 'Affiliation': 'Center for MicroElectroMechanical Systems (CMEMS), Department of Industrial Electronics, School of Engineering, University of Minho, 4800-058 Guimarães, Portugal.'}, {'ForeName': 'Nuno', 'Initials': 'N', 'LastName': 'Magalhães', 'Affiliation': 'Center for MicroElectroMechanical Systems (CMEMS), Department of Industrial Electronics, School of Engineering, University of Minho, 4800-058 Guimarães, Portugal.'}, {'ForeName': 'Cristina P', 'Initials': 'CP', 'LastName': 'Santos', 'Affiliation': 'Center for MicroElectroMechanical Systems (CMEMS), Department of Industrial Electronics, School of Engineering, University of Minho, 4800-058 Guimarães, Portugal.'}]","Sensors (Basel, Switzerland)",['10.3390/s20205876']
1716,33080863,Effects of Combining High-Definition Transcranial Direct Current Stimulation with Short-Foot Exercise on Chronic Ankle Instability: A Pilot Randomized and Double-Blinded Study.,"(1) Background: Balance decline is highly prevalent in people suffering from chronic ankle instability (CAI). The control of balance depends upon multiple neurophysiologic systems including the activation of cortical brain regions (e.g., the primary sensorimotor cortex). The excitability of this region, however, is diminished in people with CAI. In this pilot double-blinded randomized controlled trial, we tested the effects of high-definition transcranial direct current stimulation (HD-tDCS) designed to facilitate the excitability of M1 and S1 in combination with short-foot exercise (SFE) training on proprioception and dynamic balance performance in individuals with CAI. (2) Methods: Thirty young adults completed baseline assessments including the Active Movement Extent Discrimination Apparatus (AMEDA), Joint Position Reproduction (JPR) test, Y-balance test, and the Sensory Organization Test (SOT). They were then randomized to receive a four-week intervention of SFE in combination with tDCS (i.e., HD-tDCS+SFE) or sham (i.e., control) stimulation. Baseline assessments were repeated once-weekly throughout the intervention and during a two-week follow-up period. (3) Results: Twenty-eight participants completed this study. Blinding procedures were successful and no adverse events were reported. As compared to the control group, the HD-tDCS+SFE group exhibited significant improvements in the JPR test, the Y balance test, and the SOT at different time points. No group by time interaction was observed in AMEDA test performance. (4) Conclusions: HD-tDCS combined with SFE may improve dynamic balance and proprioception in CAI. Larger, more definitive trials with extended follow-up are warranted.",2020,"As compared to the control group, the HD-tDCS+SFE group exhibited significant improvements in the JPR test, the Y balance test, and the SOT at different time points.","['people with CAI', 'individuals with CAI', 'Thirty young adults', 'Chronic Ankle Instability', 'people suffering from chronic ankle instability (CAI']","['SFE in combination with tDCS (i.e., HD-tDCS+SFE) or sham (i.e., control) stimulation', 'HD-tDCS+SFE', 'Combining High-Definition Transcranial Direct Current Stimulation with Short-Foot Exercise', 'SFE', 'short-foot exercise (SFE) training', 'high-definition transcranial direct current stimulation (HD-tDCS']","['successful and no adverse events', 'JPR test, the Y balance test, and the SOT', 'dynamic balance and proprioception in CAI', 'Active Movement Extent Discrimination Apparatus (AMEDA), Joint Position Reproduction (JPR) test, Y-balance test, and the Sensory Organization Test (SOT', 'proprioception and dynamic balance performance']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3840097', 'cui_str': 'Chronic ankle instability'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0576226', 'cui_str': 'Short foot'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0442348', 'cui_str': 'Transcranial approach'}, {'cui': 'C0442831', 'cui_str': 'Direct current'}, {'cui': 'C0454370', 'cui_str': 'Foot exercises'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C1963761', 'cui_str': 'No adverse event'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C4720873', 'cui_str': 'Sensory organization test'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0033499', 'cui_str': 'Proprioception'}, {'cui': 'C3840097', 'cui_str': 'Chronic ankle instability'}, {'cui': 'C0231481', 'cui_str': 'Active movement'}, {'cui': 'C0439792', 'cui_str': 'Extent'}, {'cui': 'C0012632', 'cui_str': 'Cognitive discrimination'}, {'cui': 'C0243111', 'cui_str': 'apparatus'}]",30.0,0.261914,"As compared to the control group, the HD-tDCS+SFE group exhibited significant improvements in the JPR test, the Y balance test, and the SOT at different time points.","[{'ForeName': 'Yuanbo', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': 'School of Kinesiology, Shanghai University of Sport, Shanghai 200438, China.'}, {'ForeName': 'Keyi', 'Initials': 'K', 'LastName': 'Yin', 'Affiliation': 'School of Kinesiology, Shanghai University of Sport, Shanghai 200438, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhuang', 'Affiliation': 'School of Kinesiology, Shanghai University of Sport, Shanghai 200438, China.'}, {'ForeName': 'Cui', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'School of Kinesiology, Shanghai University of Sport, Shanghai 200438, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'School of Kinesiology, Shanghai University of Sport, Shanghai 200438, China.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'School of Kinesiology, Shanghai University of Sport, Shanghai 200438, China.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Manor', 'Affiliation': 'The Hinda and Arthur Marcus Institute for Aging Research, Hebrew Senior Life, Boston, MA 02131, USA.'}, {'ForeName': 'Junhong', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'The Hinda and Arthur Marcus Institute for Aging Research, Hebrew Senior Life, Boston, MA 02131, USA.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'School of Kinesiology, Shanghai University of Sport, Shanghai 200438, China.'}]",Brain sciences,['10.3390/brainsci10100749']
1717,33080924,The Effects of Strength and Conditioning in Physical Education on Athletic Motor Skill Competencies and Psychological Attributes of Secondary School Children: A Pilot Study.,"Leading global physical activity guidelines advocate that young children need to engage in activities that strengthen musculoskeletal tissues and improve movement skill competency. The purpose of this study was to examine the effects of delivering strength and conditioning as part of the physical education curriculum on athletic motor skill competencies (AMSC), physical performance, and psychosocial factors. Forty-six school children aged 11-14 were included in the study, and sub-divided firstly by sex and then into intervention and control groups. Intervention groups received nine lessons of strength and conditioning based activities over a six-week period, while the control groups continued with traditional physical education curricula. The resistance training skills battery (RTSB) and tuck jump assessment (TJA) assessed AMSC. Standing long jump distance assessed lower limb strength, and online surveys examined motivation, physical self-efficacy and self-esteem. Male and female intervention groups significantly improved RTSB ( p  > 0.05) whereas no changes were observed in the control groups. No changes were observed in the intervention groups TJA and only trivial and small non-significant changes in standing long jump performance. Significant increases in motivation of the male intervention group occurred. Strength and conditioning integrated in physical education can improve AMSC in short-term interventions.",2020,No changes were observed in the intervention groups TJA and only trivial and small non-significant changes in standing long jump performance.,"['young children', 'Forty-six school children aged 11-14 were included in the study, and sub-divided firstly by sex and then into intervention and control groups', 'Secondary School Children']","['Strength and Conditioning in Physical Education', 'nine lessons of strength and conditioning based activities over a six-week period, while the control groups continued with traditional physical education curricula']","['Standing long jump distance assessed lower limb strength, and online surveys examined motivation, physical self-efficacy and self-esteem', 'standing long jump performance', 'resistance training skills battery (RTSB) and tuck jump assessment (TJA) assessed AMSC', 'motivation', 'RTSB', 'athletic motor skill competencies (AMSC), physical performance, and psychosocial factors']","[{'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0260267', 'cui_str': 'School child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C1279901', 'cui_str': 'Firstly'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036530', 'cui_str': 'Secondary school'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0031805', 'cui_str': 'Education, Physical'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}]","[{'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0185026', 'cui_str': 'Plication'}, {'cui': 'C1510656', 'cui_str': 'Athletics'}, {'cui': 'C0026612', 'cui_str': 'Motor Skills'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0033963', 'cui_str': 'Psychosocial Factors'}]",46.0,0.013785,No changes were observed in the intervention groups TJA and only trivial and small non-significant changes in standing long jump performance.,"[{'ForeName': 'Ben J', 'Initials': 'BJ', 'LastName': 'Pullen', 'Affiliation': 'Youth Physical Development Centre, Cardiff Metropolitan University, Cyncoed Campus, Cardiff CF23 6XB, Wales, UK.'}, {'ForeName': 'Jon L', 'Initials': 'JL', 'LastName': 'Oliver', 'Affiliation': 'Youth Physical Development Centre, Cardiff Metropolitan University, Cyncoed Campus, Cardiff CF23 6XB, Wales, UK.'}, {'ForeName': 'Rhodri S', 'Initials': 'RS', 'LastName': 'Lloyd', 'Affiliation': 'Youth Physical Development Centre, Cardiff Metropolitan University, Cyncoed Campus, Cardiff CF23 6XB, Wales, UK.'}, {'ForeName': 'Camilla J', 'Initials': 'CJ', 'LastName': 'Knight', 'Affiliation': 'Welsh Institute of Performance Science, Sport Wales, Sophia Gardens, Cardiff CF11 9SW, Wales, UK.'}]","Sports (Basel, Switzerland)",['10.3390/sports8100138']
1718,33080934,Plasma and Urinary (Poly)phenolic Profiles after 4-Week Red Raspberry ( Rubus idaeus  L.) Intake with or without Fructo-Oligosaccharide Supplementation.,"Red raspberries (RRB) are high in anthocyanin- and ellagitannin- type (poly)phenols. This study aimed to investigate the effect of 4-week RRB supplementation on (poly)phenolic metabolism in adults with prediabetes and insulin-resistance (PreDM-IR); and whether adding fructo-oligosaccharides (FOS), prebiotics, would augment the microbial metabolites of RRB (poly)phenols. In a randomized crossover clinical trial, subjects (n = 35: PreDM-IR, n = 25; healthy Reference group, n = 10) consumed 1 cup RRB (fresh weight equivalence) per day and RRB with 8 g FOS per day each for 4 weeks in random order separated by 4-week washout. Plasma and urinary (poly)phenolic metabolites were characterized after (0-24h) consuming a RRB-based test drink (2 cups RRB) at baseline/week 0 and again after 4-week supplementations. A total of 123 (poly)phenolic metabolites were quantified. After 4-week RRB supplementation, several metabolite groups were significantly increased ( p  < 0.05), including urolithins, phenyl-γ-valerolactones, and phenolic acids. Supplementing FOS with RRB for 4 weeks enhanced benzoic acid derivatives compared to the baseline ( p  < 0.05). Specific effects of supplementation by metabolic status indicated 4-week RRB supplementation significantly increased microbial metabolites that were lower in PreDM-IR group. Our results suggest alterations in the capacity of PreDM-IR group to metabolize and render bioavailable raspberry-derived (poly)phenols when consumed regularly.",2020,"After 4-week RRB supplementation, several metabolite groups were significantly increased ( p  < 0.05), including urolithins, phenyl-γ-valerolactones, and phenolic acids.","['adults with prediabetes and insulin-resistance (PreDM-IR', 'subjects (n = 35: PreDM-IR, n = 25; healthy Reference group, n = 10']","['4-Week Red Raspberry ( Rubus idaeus  L', '4-week RRB supplementation', 'RRB supplementation', 'consumed 1 cup RRB', 'Intake with or without Fructo-Oligosaccharide Supplementation']","['Plasma and urinary (poly)phenolic metabolites', 'Red raspberries (RRB', 'benzoic acid derivatives', 'Plasma and Urinary (Poly)phenolic Profiles', 'microbial metabolites', 'urolithins, phenyl-γ-valerolactones, and phenolic acids']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332575', 'cui_str': 'Red color'}, {'cui': 'C0453292', 'cui_str': 'Raspberries'}, {'cui': 'C1446808', 'cui_str': 'Rubus idaeus'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0220647', 'cui_str': 'Carcinoma of unknown primary'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0873033', 'cui_str': 'fructooligosaccharide'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0359916', 'cui_str': 'Substance with phenol structure'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0332575', 'cui_str': 'Red color'}, {'cui': 'C0453292', 'cui_str': 'Raspberries'}, {'cui': 'C0053225', 'cui_str': 'Benzoic acid'}, {'cui': 'C0243072', 'cui_str': 'derivatives'}, {'cui': 'C0443441', 'cui_str': 'Valerolactone'}, {'cui': 'C2586298', 'cui_str': 'Hydroxybenzoic acid'}]",123.0,0.020923,"After 4-week RRB supplementation, several metabolite groups were significantly increased ( p  < 0.05), including urolithins, phenyl-γ-valerolactones, and phenolic acids.","[{'ForeName': 'Xuhuiqun', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Food Science and Nutrition and Center for Nutrition Research, Institute for Food Safety and Health, Illinois Institute of Technology, Chicago, IL 60616, USA.'}, {'ForeName': 'Amandeep', 'Initials': 'A', 'LastName': 'Sandhu', 'Affiliation': 'Department of Food Science and Nutrition and Center for Nutrition Research, Institute for Food Safety and Health, Illinois Institute of Technology, Chicago, IL 60616, USA.'}, {'ForeName': 'Indika', 'Initials': 'I', 'LastName': 'Edirisinghe', 'Affiliation': 'Department of Food Science and Nutrition and Center for Nutrition Research, Institute for Food Safety and Health, Illinois Institute of Technology, Chicago, IL 60616, USA.'}, {'ForeName': 'Britt M', 'Initials': 'BM', 'LastName': 'Burton-Freeman', 'Affiliation': 'Department of Food Science and Nutrition and Center for Nutrition Research, Institute for Food Safety and Health, Illinois Institute of Technology, Chicago, IL 60616, USA.'}]","Molecules (Basel, Switzerland)",['10.3390/molecules25204777']
1719,33081069,"Effectiveness of a Multicomponent Treatment for Fibromyalgia Based on Pain Neuroscience Education, Exercise Therapy, Psychological Support, and Nature Exposure (NAT-FM): A Pragmatic Randomized Controlled Trial.","A recent study (FIBROWALK has supported the effectiveness of a multicomponent treatment based on pain neuroscience education (PNE), exercise therapy (TE), cognitive behavioral therapy (CBT), and mindfulness in patients with fibromyalgia. The aim of the present RCT was: (a) to analyze the effectiveness of a 12-week multicomponent treatment (nature activity therapy for fibromyalgia, NAT-FM) based on the same therapeutic components described above plus nature exposure to maximize improvements in functional impairment (primary outcome), as well as pain, fatigue, anxiety-depression, physical functioning, positive and negative affect, self-esteem, and perceived stress (secondary outcomes), and kinesiophobia, pain catastrophizing thoughts, personal perceived competence, and cognitive emotion regulation (process variables) compared with treatment as usual (TAU); (b) to preliminarily assess the effects of the nature-based activities included (yoga, Nordic walking, nature photography, and Shinrin Yoku); and (c) to examine whether the positive effects of TAU + NAT-FM on primary and secondary outcomes at post-treatment were mediated through baseline to six-week changes in process variables. A total of 169 FM patients were randomized into two study arms: TAU + NAT-FM vs. TAU alone. Data were collected at baseline, at six-week of treatment, at post-treatment, and throughout treatment by ecological momentary assessment (EMA). Using an intention to treat (ITT) approach, linear mixed-effects models and mediational models through path analyses were computed. Overall, TAU + NAT-FM was significantly more effective than TAU at posttreatment for the primary and secondary outcomes evaluated, as well as for the process variables. Moderate-to-large effect sizes were achieved at six-weeks for functional impairment, anxiety, kinesiophobia, perceived competence, and positive reappraisal. The number needed to treat (NNT) was 3 (95%CI = 1.6-3.2). The nature activities yielded an improvement in affective valence, arousal, dominance, fatigue, pain, stress, and self-efficacy. Kinesiophobia and perceived competence were the mediators that could explain a significant part of the improvements obtained with TAU + NAT-FM treatment. TAU + NAT-FM is an effective co-adjuvant multicomponent treatment for improving FM-related symptoms.",2020,"Moderate-to-large effect sizes were achieved at six-weeks for functional impairment, anxiety, kinesiophobia, perceived competence, and positive reappraisal.","['169 FM patients', 'patients with fibromyalgia']","['Multicomponent Treatment', 'exercise therapy (TE), cognitive behavioral therapy (CBT', 'multicomponent treatment (nature activity therapy', 'TAU + NAT-FM vs. TAU alone', 'TAU + NAT-FM']","['Pain Neuroscience Education, Exercise Therapy, Psychological Support, and Nature Exposure (NAT-FM', 'pain, fatigue, anxiety-depression, physical functioning, positive and negative affect, self-esteem, and perceived stress (secondary outcomes), and kinesiophobia, pain catastrophizing thoughts, personal perceived competence, and cognitive emotion regulation (process variables', 'number needed to treat (NNT', 'affective valence, arousal, dominance, fatigue, pain, stress, and self-efficacy', 'usual (TAU']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0349590', 'cui_str': 'Nature'}, {'cui': 'C0150123', 'cui_str': 'Activity care'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}, {'cui': 'C0067787', 'cui_str': 'N-acetyltalosaminuronic acid'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0027910', 'cui_str': 'Neurosciences'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0600015', 'cui_str': 'Emotional support'}, {'cui': 'C0349590', 'cui_str': 'Nature'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0067787', 'cui_str': 'N-acetyltalosaminuronic acid'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0338908', 'cui_str': 'Mixed anxiety and depressive disorder'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}, {'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}, {'cui': 'C0039869', 'cui_str': 'Thinking'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C3179138', 'cui_str': 'Numbers Needed To Treat'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C1287621', 'cui_str': 'Eye dominance - finding'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}]",169.0,0.0817792,"Moderate-to-large effect sizes were achieved at six-weeks for functional impairment, anxiety, kinesiophobia, perceived competence, and positive reappraisal.","[{'ForeName': 'Mayte', 'Initials': 'M', 'LastName': 'Serrat', 'Affiliation': ""Unitat d'Expertesa en Síndromes de Sensibilització Central, Servei de Reumatologia, Vall d'Hebron Hospital Universitari, Vall d'Hebron Barcelona Hospital Campus, Passeig Vall d'Hebron 119-129, 08035 Barcelona, Spain.""}, {'ForeName': 'Míriam', 'Initials': 'M', 'LastName': 'Almirall', 'Affiliation': ""Unitat d'Expertesa en Síndromes de Sensibilització Central, Servei de Reumatologia, Vall d'Hebron Hospital Universitari, Vall d'Hebron Barcelona Hospital Campus, Passeig Vall d'Hebron 119-129, 08035 Barcelona, Spain.""}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Musté', 'Affiliation': ""Unitat d'Expertesa en Síndromes de Sensibilització Central, Servei de Reumatologia, Vall d'Hebron Hospital Universitari, Vall d'Hebron Barcelona Hospital Campus, Passeig Vall d'Hebron 119-129, 08035 Barcelona, Spain.""}, {'ForeName': 'Juan P', 'Initials': 'JP', 'LastName': 'Sanabria-Mazo', 'Affiliation': ""Stress and Health Research Group, Departament de Psicologia Bàsica, Evolutiva i de l'Educació, Universitat Autònoma de Barcelona, 08193 Bellaterra, Spain.""}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Feliu-Soler', 'Affiliation': ""Stress and Health Research Group, Departament de Psicologia Bàsica, Evolutiva i de l'Educació, Universitat Autònoma de Barcelona, 08193 Bellaterra, Spain.""}, {'ForeName': 'Jorge L', 'Initials': 'JL', 'LastName': 'Méndez-Ulrich', 'Affiliation': 'Research Group on Socioeducative Interventions in Childhood and Youth (GRISIJ), Department of Methods of Research and Diagnosis in Education, Faculty on Education, University of Barcelona, 08007 Barcelona, Spain.'}, {'ForeName': 'Juan V', 'Initials': 'JV', 'LastName': 'Luciano', 'Affiliation': 'Institut de Recerca Sant Joan de Déu, Esplugues de Llobregat, 08950 Catalonia, Spain.'}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Sanz', 'Affiliation': ""Stress and Health Research Group, Departament de Psicologia Bàsica, Evolutiva i de l'Educació, Universitat Autònoma de Barcelona, 08193 Bellaterra, Spain.""}]",Journal of clinical medicine,['10.3390/jcm9103348']
1720,33081070,"Recruitment and Baseline Characteristics of Participants in the ""Sanadak"" Trial: A Self-Help App for Syrian Refugees with Post-traumatic Stress.","Many Syrian refugees residing in Germany have been exposed to traumatizing events, while treatment options are scarce. Therefore, the self-help app ""Sanadak"" was developed to target post-traumatic stress in Syrian refugees. We aimed to inspect the recruitment and baseline characteristics of the participants in the trial, which is conducted to evaluate the app. Analyses were based on the recruitment sample ( n  = 170) and the trial sample ( n  = 133). Data were collected during structured face-to-face interviews in the Arabic language. Targeted outcomes included post-traumatic stress (primary; Post-traumatic Diagnostic Scale for DSM-5/PDS-5) and depressive symptoms, anxiety, resilience, among others (secondary). Recruited individuals were  M  = 32.8 (SD = 11.2, range = 18-65) years old; 38.8% were women. The average PDS-5 score was 23.6 (SD = 13.2) regarding trauma exposure, which was most frequently related to experiencing military- or combat-related events (32.9%). Moreover, 46.5% had major depression and 51.8% showed low resilience. Anxiety was present in 40.6% of the trial participants. Psychological distress was high in Syrian refugees residing in Germany, enrolled in a trial targeting post-traumatic stress. This underlines the need for intervention. Our results provide important figures on the mental health of a not well-studied population group in Germany.",2020,"Psychological distress was high in Syrian refugees residing in Germany, enrolled in a trial targeting post-traumatic stress.","['M  = 32.8 (SD = 11.2, range = 18-65) years old; 38.8% were women', 'Recruited individuals were']",[],"['Psychological distress', 'post-traumatic stress (primary; Post-traumatic Diagnostic Scale for DSM-5/PDS-5) and depressive symptoms, anxiety, resilience, among others (secondary', 'Anxiety', 'major depression', 'average PDS-5 score']","[{'cui': 'C4517531', 'cui_str': '11.2'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",[],"[{'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0271829', 'cui_str': ""Pendred's syndrome""}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.14662,"Psychological distress was high in Syrian refugees residing in Germany, enrolled in a trial targeting post-traumatic stress.","[{'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Röhr', 'Affiliation': 'Institute of Social Medicine, Occupational Health and Public Health (ISAP), Medical Faculty, University of Leipzig, 04103 Leipzig, Germany.'}, {'ForeName': 'Franziska U', 'Initials': 'FU', 'LastName': 'Jung', 'Affiliation': 'Institute of Social Medicine, Occupational Health and Public Health (ISAP), Medical Faculty, University of Leipzig, 04103 Leipzig, Germany.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Renner', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Medical Center Leipzig, 04103 Leipzig, Germany.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Plexnies', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Medical Center Leipzig, 04103 Leipzig, Germany.'}, {'ForeName': 'Rahel', 'Initials': 'R', 'LastName': 'Hoffmann', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Medical Center Leipzig, 04103 Leipzig, Germany.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Dams', 'Affiliation': 'Department of Health Economics and Health Services Research, Hamburg Center for Health Economics, University Medical Center Hamburg-Eppendorf, 20246 Hamburg, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Grochtdreis', 'Affiliation': 'Department of Health Economics and Health Services Research, Hamburg Center for Health Economics, University Medical Center Hamburg-Eppendorf, 20246 Hamburg, Germany.'}, {'ForeName': 'Hans-Helmut', 'Initials': 'HH', 'LastName': 'König', 'Affiliation': 'Department of Health Economics and Health Services Research, Hamburg Center for Health Economics, University Medical Center Hamburg-Eppendorf, 20246 Hamburg, Germany.'}, {'ForeName': 'Anette', 'Initials': 'A', 'LastName': 'Kersting', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Medical Center Leipzig, 04103 Leipzig, Germany.'}, {'ForeName': 'Steffi G', 'Initials': 'SG', 'LastName': 'Riedel-Heller', 'Affiliation': 'Institute of Social Medicine, Occupational Health and Public Health (ISAP), Medical Faculty, University of Leipzig, 04103 Leipzig, Germany.'}]",International journal of environmental research and public health,['10.3390/ijerph17207578']
1721,33081083,A Rose Extract Protects the Skin against Stress Mediators: A Potential Role of Olfactory Receptors.,"Olfactory receptors (ORs) are expressed and active in various human tissues, including the skin. Although the sense of smell plays an important physiological role in the regulation of mood and stress, a link between olfactive compounds, ORs, and skin stress has yet to be established. This study aims to investigate the role of newly identified skin ORs and agonists in the modulation of skin stress. Screening for odorant molecules was done with cAMP functional assay to identify OR agonists. RT-qPCR and immunofluorescence microscopy were conducted to identify and quantify ORs in epidermal keratinocytes (NHEKs) and human skin explants, as well as to evaluate specific markers (G6PDH, loricrin, and γH2AX) of stress-induced skin alterations. A randomized double-blinded, split-face clinical study was performed on a panel of stressed women to measure the benefits of OR agonist treatment for skin. Three new ORs (OR10A6, OR2AG2, and OR11H4) were identified in skin. A specific Rose extract and its major constituent (phenylethyl alcohol) were found to activate these ORs. The extract composition was revealed by both GC/FID and GC/MS analyses simultaneously and showed the presence of 34 volatiles molecules. Moreover, epinephrine induces a skin stress response characterized by increased expression of G6PD, loricrin, and γH2AX biomarkers, and a decrease of OR expression. These effects were prevented in the presence of rose extract and its benefits were confirmed clinically by a decrease in the appearance of under-eye dark circles. Altogether, our findings suggest that ORs may represent a new, promising way to treat stress-associated skin disorders.",2020,These effects were prevented in the presence of rose extract and its benefits were confirmed clinically by a decrease in the appearance of under-eye dark circles.,[],['epinephrine'],"['appearance of under-eye dark circles', 'Skin against Stress Mediators', 'extract composition', 'skin stress response', 'OR expression', 'expression of G6PD, loricrin, and γH2AX biomarkers']",[],"[{'cui': 'C0014563', 'cui_str': 'Epinephrine'}]","[{'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0332582', 'cui_str': 'Dark color'}, {'cui': 'C0231706', 'cui_str': 'Circling gait'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0017757', 'cui_str': 'Glucose-6-phosphate dehydrogenase'}, {'cui': 'C0083258', 'cui_str': 'loricrin'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",,0.0258105,These effects were prevented in the presence of rose extract and its benefits were confirmed clinically by a decrease in the appearance of under-eye dark circles.,"[{'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Duroux', 'Affiliation': 'Department of Research and Development, International Flavors and Fragrances-Lucas Meyer Cosmetics, 31036 Toulouse CEDEX, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Mandeau', 'Affiliation': 'Department of Research and Development, International Flavors and Fragrances-Lucas Meyer Cosmetics, 31036 Toulouse CEDEX, France.'}, {'ForeName': 'Gaelle', 'Initials': 'G', 'LastName': 'Guiraudie-Capraz', 'Affiliation': 'Institute of Neurophysiopathology, CNRS, Aix-Marseille University, UMR 7051, CEDEX 15, F-13344 Marseille, France.'}, {'ForeName': 'Yannick', 'Initials': 'Y', 'LastName': 'Quesnel', 'Affiliation': 'ChemCom S.A., B-1070 Brussels, Belgium.'}, {'ForeName': 'Estelle', 'Initials': 'E', 'LastName': 'Loing', 'Affiliation': 'Department of Research and Development, International Flavors and Fragrances-Lucas Meyer Cosmetics, Quebec, QC G1V 4M6, Canada.'}]","Molecules (Basel, Switzerland)",['10.3390/molecules25204743']
1722,33081299,Could Fecal Microbiota Be a Useful Indicator of Serum Cholesterol Levels among Men?,"Trepidation with blood tests among men may result in fewer routine screening and examination of their cardiovascular risk factors. Associations between fecal microbiota and serum cholesterols have not been well-established. The aim of this study was to explore such association in order to determine the potential of fecal microbiota as a non-invasive alternate predictor of serum cholesterols. Secondary data from a cross-over trial were analyzed. Associations between fecal microbiota, mainly  Bifidobacterium  and  Clostridial  group, of healthy men ( n  = 16) and their total cholesterols, low and high-density lipoprotein cholesterols (LDL-C and HDL-C) were assessed using generalized estimating equations, adjusted for diet intervention, diet order, frequency of defecation and flatulence level. For every two-fold increase in fecal  Bifidobacterium , geometric mean of LDL-C increases by a factor of 1.23 (95% CI: 1.01, 1.49) whilst that of HDL-C increases by a factor of 1.07 (95% CI: 1.03, 1.10). For every two-fold increase in  Clostridial  group ( C. ramosum ,  C. spiroforme  and  C. cocleatum ), geometric mean of HDL-C decreases by a factor of 1.10 (95% CI: -1.16, -1.03). No association was found between total bacteria and serum cholesterols. Fecal  Bifidobacterium  spp. and  Clostridium  spp., are potential non-invasive surrogate markers of men's serum cholesterols.",2020,No association was found between total bacteria and serum cholesterols.,[],[],"['total bacteria and serum cholesterols', 'fecal  Bifidobacterium , geometric mean of LDL-C', 'Serum Cholesterol Levels', 'total cholesterols, low and high-density lipoprotein cholesterols (LDL-C and HDL-C']",[],[],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0587184', 'cui_str': 'Serum cholesterol measurement'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}]",,0.0219465,No association was found between total bacteria and serum cholesterols.,"[{'ForeName': 'HuiJun', 'Initials': 'H', 'LastName': 'Chih', 'Affiliation': 'School of Public Health, Curtin University, Bentley, WA 6102, Australia.'}, {'ForeName': 'Stuart C', 'Initials': 'SC', 'LastName': 'Smith', 'Affiliation': 'School of Exercise and Nutrition Sciences, Deakin University, Burwood, VIC 3216, Australia.'}, {'ForeName': 'Ramon S', 'Initials': 'RS', 'LastName': 'Hall', 'Affiliation': 'School of Exercise and Nutrition Sciences, Deakin University, Burwood, VIC 3216, Australia.'}, {'ForeName': 'Stuart K', 'Initials': 'SK', 'LastName': 'Johnson', 'Affiliation': 'School of Molecular and Life Sciences, Curtin University, Bentley, WA 6102, Australia.'}]",Journal of personalized medicine,['10.3390/jpm10040175']
1723,33081425,"A Multicentre, Multinational, Open-Label, 52-Week Extension Study of Gemigliptin (LC15-0444) Monotherapy in Patients with Type 2 Diabetes Mellitus.","The purpose of this extension study was to assess the long-term efficacy and safety of gemigliptin 50 mg in patients with type 2 diabetes mellitus (T2DM). Patients with T2DM who had completed the initial 24-week study comparing gemigliptin monotherapy with placebo were eligible to enrol. In the open-label, 28-week extension study, all enrolled patients received gemigliptin, regardless of the treatment received during the initial 24-week study period. The mean reduction±standard deviation (SD) in glycosylated hemoglobin (HbA1c) observed after 24 weeks of treatment (-0.6%±1.1%) was further decreased for the gemi-gemi group and the mean change in HbA1c at week 52 from baseline was -0.9%±1.2% (P<0.0001). For the pbo-gemi group, HbA1c decreased after they were switched to gemigliptin, and the mean change in HbA1c at week 52 from baseline was -0.7%±1.2% (P<0.0001). Furthermore, the overall incidence of adverse events demonstrated that gemigliptin was safe and well tolerated up to 52 weeks.",2020,"Furthermore, the overall incidence of adverse events demonstrated that gemigliptin was safe and well tolerated up to 52 weeks.","['Patients with T2DM who had completed the initial 24-week study comparing', 'Patients with Type 2 Diabetes Mellitus', 'patients with type 2 diabetes mellitus (T2DM']","['gemigliptin monotherapy with placebo', 'gemigliptin', 'Gemigliptin (LC15-0444) Monotherapy']","['mean change in HbA1c', 'mean reduction±standard deviation (SD) in glycosylated hemoglobin (HbA1c', 'safe and well tolerated']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2607564', 'cui_str': 'LC15-0444'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0017853', 'cui_str': 'Glycosylated hemoglobin'}]",,0.024857,"Furthermore, the overall incidence of adverse events demonstrated that gemigliptin was safe and well tolerated up to 52 weeks.","[{'ForeName': 'Sae Jeong', 'Initials': 'SJ', 'LastName': 'Yang', 'Affiliation': ""Department of Endocrinology, Daerim St. Mary's Hospital, Seoul, Korea.""}, {'ForeName': 'Kyung Wan', 'Initials': 'KW', 'LastName': 'Min', 'Affiliation': 'Department of Internal Medicine, Nowon Eulji Medical Center, Eulji University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Sandeep Kumar', 'Initials': 'SK', 'LastName': 'Gupta', 'Affiliation': 'M.V. Hospital and Research Centre, Lucknow, India.'}, {'ForeName': 'Joong Yeol', 'Initials': 'JY', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Vyankatesh', 'Initials': 'V', 'LastName': 'K Shivane', 'Affiliation': 'Research Health Institute in Diabetes, Endocrinology and Metabolism (RHIDEM), Mumbai, India.'}, {'ForeName': 'Pankaj Kumar', 'Initials': 'PK', 'LastName': 'Agarwal', 'Affiliation': 'Hormone Care and Research Center, Ghaziabad, India.'}, {'ForeName': 'Doo Man', 'Initials': 'DM', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Hallym University Kangdong Sacred Heart Hospital, Seoul, Korea.'}, {'ForeName': 'Yong Esong', 'Initials': 'YE', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Inha University Hospital, Inha University College of Medicine, Incheon, Korea.'}, {'ForeName': 'Sei Hyun', 'Initials': 'SH', 'LastName': 'Baik', 'Affiliation': 'Department of Endocrinology, Korea University Guro Hospital, Seoul, Korea.'}]",Diabetes & metabolism journal,['10.4093/dmj.2020.0047']
1724,33081432,The Effect of Melatonin on the Serum Level of Interleukin 6 and Interleukin 9 in Coronary Artery Bypass Grafting Surgery.,"OBJECTIVE


Cardiopulmonary bypass has been recognized as one of the main causes of systemic inflammatory response syndrome, leading to post-operative complications. The aim of this study was to investigate the effect of melatonin on the serum levels of interleukin 6 (IL-6) and IL-9 in patients undergoing coronary artery bypass grafting surgery.
METHODS


Forty-four patients undergoing elective coronary artery bypass surgery were randomly allocated into two study groups of melatonin (n = 23) and placebo (n = 21). Patients in the melatonin group received two melatonin tablet, 5 mg daily for 3 days before surgery, 10 mg tablet (two doses of 5 mg) 1 h before induction of anesthesia and finally, 10 mg melatonin tablet in the intensive care unit, placebo group patients received placebo at the same time periods. Serum levels of IL-9 and IL-6 were measured as baseline (T1), before induction of anesthesia (T2), 6 and 24 h after off pump (T3, T4). Data were analyzed using SPSS 23 software (IBM Corp., Armonk, NY, USA).
RESULTS


The mean serum level of IL-6 was significantly lower in the melatonin group at T3 and T4 (p ＜ 0.05). Also, in both groups, serum levels of IL-6 in T3 showed a significant increase compared to T1. Serum levels of IL-9 had no significant difference between the two groups at T1, T2, T3, and T4.
CONCLUSION


The results of this study showed that pre-operative melatonin administration could modify inflammatory cytokines secretion such as IL-6 while it has no significant effect on the serum levels of IL- 9. Neither of the changes was clinically significant.",2020,"Serum levels of IL-9 had no significant difference between the two groups at T1, T2, T3, and T4.
","['Forty-four patients undergoing elective coronary artery bypass surgery', 'patients undergoing coronary artery bypass grafting surgery', 'Coronary Artery Bypass Grafting Surgery']","['melatonin', 'placebo', 'Melatonin', 'melatonin tablet']","['mean serum level of IL-6', 'Serum levels of IL-9', 'Serum Level of Interleukin 6 and Interleukin 9', 'serum levels of IL-6', 'serum levels of interleukin 6 (IL-6) and IL-9', 'Serum levels of IL-9 and IL-6']","[{'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}]","[{'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0085424', 'cui_str': 'Interleukin-9'}]",44.0,0.380128,"Serum levels of IL-9 had no significant difference between the two groups at T1, T2, T3, and T4.
","[{'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Jouybar', 'Affiliation': 'Assistant Professor of Cardiac Anesthesia, Anesthesiology and Critical Care Research Center, Shiraz University of Medical Science, Shiraz, Iran.'}, {'ForeName': 'Mahtab', 'Initials': 'M', 'LastName': 'Setoodeh', 'Affiliation': 'MD Anesthesiologist, Anesthesiology and Critical Care Research Center, Shiraz University of Medical Science, Shiraz, Iran.'}, {'ForeName': 'Zeinabsadat Fattahi', 'Initials': 'ZF', 'LastName': 'Saravi', 'Affiliation': 'Assistant Professor of Anesthesia and Critical Care, Anesthesiology and Critical Care Research Center, Shiraz University of Medical Science, Shiraz, Iran.'}, {'ForeName': 'Sedigheh', 'Initials': 'S', 'LastName': 'Ahmadi', 'Affiliation': 'Assistant Professor of Cardiac Anesthesia, Fasa University of Medical Science, Fasa, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Karami', 'Affiliation': 'Assistant Professor of Cardiac Anesthesia, Anesthesiology and Critical Care Research Center, Shiraz University of Medical Science, Shiraz, Iran.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Khademi', 'Affiliation': 'Assosiated Professor of Cardiac Anesthesia, Anesthesiology and Critical Care Research Center, Shiraz University of Medical Science, Shiraz, Iran.'}, {'ForeName': 'Ahad', 'Initials': 'A', 'LastName': 'Izadpanah', 'Affiliation': 'MD Anesthesiologist, Anesthesiology and Critical Care Research Center, Shiraz University of Medical Science, Shiraz, Iran.'}, {'ForeName': 'Mansour', 'Initials': 'M', 'LastName': 'Jannati', 'Affiliation': 'Assosiated Professor of Cardiovascular Surgery, Cardiovascular Research Center, Shiraz University of Medical Science, Shiraz, Iran.'}, {'ForeName': 'Masih', 'Initials': 'M', 'LastName': 'Shafa', 'Affiliation': 'Assosiated Professor of Cardiovascular Surgery, Cardiovascular Research Center, Shiraz University of Medical Science, Shiraz, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Asadpour', 'Affiliation': 'Assosiated Professor of Pharmacology, Anesthesiology and Critical Care Research Center, Shiraz University of Medical Science, Shiraz, Iran.'}, {'ForeName': 'Farzaneh', 'Initials': 'F', 'LastName': 'Masih', 'Affiliation': 'Anesthesiology and Critical Care Research Center, Shiraz University of Medical Science, Shiraz, Iran.'}, {'ForeName': 'Mahyar', 'Initials': 'M', 'LastName': 'Malekzadeh', 'Affiliation': 'Shiraz Institute for Cancer Research, School of Medicine, Shiraz University of Medical Science, Shiraz, Iran.'}]",Asian journal of anesthesiology,['10.6859/aja.202003_58(1).0005']
1725,33081444,[Developmental disorders of academic skills in children: the efficacy and safety of Tenoten for children in the multicenter double-blind placebo-controlled randomized study].,"OBJECTIVE


To evaluate the efficacy and safety of tenoten for children in the treatment of specific developmental disorders of academic skills in children of 1-3 grades.
MATERIAL AND METHODS


Two hundred and forty children, aged 7-9 years, (Total set, Safety population) with verified specific reading disorder (F81.0), specific spelling disorder (F81.1), specific disorder of arithmetical skills (F81.2), mixed disorder of scholastic skills (F81.3; F81.2+F81.0, or F81.2+F81.1, or F81.2+F81.0+F81.1), diagnosed with the use of logopedic or psychological testing (15-35 scores in Fotekova T.A. and Akhutina T.V. reading and writing tests; 5-15 scores in arithmetical subscale of the Wechsler Intelligence Scale for Children) were enrolled in the study. CT was conducted in 10 clinical centers in Russian Federation in 2015- 2019. Patients were randomized into two groups. The first one ( n =122) received tenoten for children in a dose of 1 tablet 3 times a day, the second one ( n =118) was administered placebo in the same dosage regimen. The clinical data on 237 children (121 of the tenoten group and 116 of the placebo group) were used for Intention-to-treat efficacy analysis. Data on 220 children (115 of the tenoten group and 105 of the placebo group) were included in Per-protocol analysis. The duration of study was 12 weeks. The mean total academic skills (reading, spelling, and counting) score in groups after 12 weeks of treatment was set as the primary efficacy endpoint.
RESULTS


The mean total academic skills score increased by 18.55±15.87 points. The significant total difference between the median changes in the total score in the tenoten and placebo groups was 5 points. There was a trend towards positive changes in reading and spelling mean scores in tests that didn't reach statistical significance due to lack of normal distribution of points in samples. There were 73 adverse events (AEs) in 42 patients of the tenoten group and 95 AEs in 31 children of the placebo group. No serious or severe AEs were registered in the tenoten group. No AEs definitely related to the study treatment were registered. No negative drug interactions were observed in the tenoten group.
CONCLUSIONS


Tenoten for children is an effective and safe treatment for specific developmental disorders of academic skills in primary school children. Tenoten for children is well tolerated. The treatment is characterized by a high level of adherence of children and their parents to therapy.",2020,There was a trend towards positive changes in reading and spelling mean scores in tests that didn't reach statistical significance due to lack of normal distribution of points in samples.,"['10 clinical centers in Russian Federation in 2015- 2019', '237 children (121 of the tenoten group and 116 of the', 'Two hundred and forty children, aged 7-9 years, (Total set, Safety population) with verified specific reading disorder (F81.0), specific spelling disorder (F81.1), specific disorder of arithmetical skills (F81.2), mixed disorder of scholastic skills (F81.3; F81.2+F81.0, or F81.2+F81.1, or F81.2+F81.0+F81.1), diagnosed with the use of logopedic or psychological testing (15-35 scores in Fotekova T.A. and Akhutina T.V. reading and writing tests', 'children of 1-3 grades', 'primary school children', 'children', '220 children (115 of the tenoten group and 105 of the placebo group) were included in Per-protocol analysis', '5-15 scores in arithmetical subscale of the Wechsler Intelligence Scale for Children']","['CT', 'placebo']","['mean total academic skills score', 'total score', 'efficacy and safety', 'serious or severe AEs', 'negative drug interactions', 'tolerated', 'mean total academic skills (reading, spelling, and counting) score']","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0035970', 'cui_str': 'Russian federation - Europe'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C2354538', 'cui_str': 'tenoten'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0037789', 'cui_str': 'Specific reading disorder'}, {'cui': 'C0349326', 'cui_str': 'Specific spelling disorder'}, {'cui': 'C0494427', 'cui_str': 'Specific disorder of arithmetical skills'}, {'cui': 'C0349327', 'cui_str': 'Mixed disorder of scholastic skills'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0033905', 'cui_str': 'Psychologic test'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0018582', 'cui_str': 'Handwriting'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0204457', 'cui_str': 'Wechsler intelligence scale for children'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0678798', 'cui_str': 'Adverse drug interaction'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0439157', 'cui_str': 'counts'}]",237.0,0.109164,There was a trend towards positive changes in reading and spelling mean scores in tests that didn't reach statistical significance due to lack of normal distribution of points in samples.,"[{'ForeName': 'N N', 'Initials': 'NN', 'LastName': 'Zavadenko', 'Affiliation': 'Pirogov Russian National Research Medical University, Moscow, Russia.'}, {'ForeName': 'N V', 'Initials': 'NV', 'LastName': 'Skripchenko', 'Affiliation': ""Scientific Research Institute of Children's Infections of the Federal Medical and Biological Agency, St. Petersburg, Russia.""}, {'ForeName': 'D D', 'Initials': 'DD', 'LastName': 'Gaynetdinova', 'Affiliation': 'Kazan State Medical University, Kazan, Russia.'}, {'ForeName': 'O V', 'Initials': 'OV', 'LastName': 'Khaletskaya', 'Affiliation': 'Privolzhsky Research Medical University, Nizhniy Novgorod, Russia.'}, {'ForeName': 'O B', 'Initials': 'OB', 'LastName': 'Doronina', 'Affiliation': 'Novosibirsk State Medical University, Novosibirsk, Russia.'}, {'ForeName': 'N Yu', 'Initials': 'NY', 'LastName': 'Suvorinova', 'Affiliation': 'Pirogov Russian National Research Medical University, Moscow, Russia.'}, {'ForeName': 'E Sh', 'Initials': 'ES', 'LastName': 'Sagautdinova', 'Affiliation': ""Sverdlovsk Region Children's Clinical Hospital of Rehabilitation The Scientific and Practical Center Bonum, Ekaterinburg, Russia.""}, {'ForeName': 'Yu O', 'Initials': 'YO', 'LastName': 'Boychevskaya', 'Affiliation': 'Specialized Clinical Psychiatric Hospital No. 1 of the Ministry of Health of the Krasnodar Region, Krasnodar, Russia.'}, {'ForeName': 'M V', 'Initials': 'MV', 'LastName': 'Panteleeva', 'Affiliation': 'Moscow Regional Research and Clinical Institute («MONIKI»), Moscow, Russia.'}, {'ForeName': 'E D', 'Initials': 'ED', 'LastName': 'Teplyakova', 'Affiliation': ""«Children's city polyclinic No. 4» of Rostov-on-Don, Rostov-on-Don, Russia.""}, {'ForeName': 'T I', 'Initials': 'TI', 'LastName': 'Antonova', 'Affiliation': ""St. Petersburg «Children's city clinic No. 35», St. Petersburg, Russia.""}]",Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova,['10.17116/jnevro202012009128']
1726,33081445,[The optimization of differential diagnosis and treatment of cervical radiculopathy (SHERPA study)].,"OBJECTIVE


To improve the algorithm of differential diagnosis and complex treatment of patients with CR.
MATERIAL AND METHODS


Forty-two patients with CR were divided into 2 groups. Patients of the first group ( n =21) received basic treatment (NSAID, myorelaxants, local injections with glucocorticoids (on demand), B vitamins and non-pharmacological methods) and the anticholinesterase drug ipidacrine. The second group ( n =21) had only basic treatment. The total duration of the study was 45 days. The effectiveness of treatment was evaluated with VAS, NDI, GROC and total duration of disability period.
RESULTS


A battery of tests for the diagnosis of CR that included Spurling test, motor strength deficiency, ULTT, pain pattern, shoulder adduction test (diagnostic complex SPASIBO), has been developed. A positive result of all 5 tests guarantees the 94.7% accuracy of CR diagnosis. The application of ipidacrine has allowed a significant ( p <0.05) reduction of pain, enhancement of daily living activities and subjective improvement of well-being of patients after 1 month of treatment and mostly after 45 days. Besides, there was a considerable ( p <0.05) reduction of the disability period in the first group of patients compared to the control one.
CONCLUSION


The diagnostic complex SPASIBO should be used in diagnosis of CR. It is highly recommended to include ipidacrine in the complex treatment of CR.",2020,"The application of ipidacrine has allowed a significant ( p <0.05) reduction of pain, enhancement of daily living activities and subjective improvement of well-being of patients after 1 month of treatment and mostly after 45 days.","['patients with CR', 'Forty-two patients with CR']","['basic treatment (NSAID, myorelaxants, local injections with glucocorticoids (on demand), B vitamins and non-pharmacological methods) and the anticholinesterase drug ipidacrine', 'ipidacrine']","['pain, enhancement of daily living activities and subjective improvement', 'VAS, NDI, GROC and total duration of disability period', 'disability period']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319566', 'cui_str': '42'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0042849', 'cui_str': 'Vitamin B Complex'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0008425', 'cui_str': 'Cholinesterase inhibitor'}, {'cui': 'C0051691', 'cui_str': 'ipidacrine'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1563705', 'cui_str': 'Diabetes Insipidus, Nephrogenic, Type I'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0231170', 'cui_str': 'Disability'}]",42.0,0.0135411,"The application of ipidacrine has allowed a significant ( p <0.05) reduction of pain, enhancement of daily living activities and subjective improvement of well-being of patients after 1 month of treatment and mostly after 45 days.","[{'ForeName': 'I N', 'Initials': 'IN', 'LastName': 'Samartsev', 'Affiliation': 'Military Medical Academy, St-Petersburg, Russia.'}, {'ForeName': 'S A', 'Initials': 'SA', 'LastName': 'Zhivolupov', 'Affiliation': 'Military Medical Academy, St-Petersburg, Russia.'}, {'ForeName': 'M N', 'Initials': 'MN', 'LastName': 'Vorobyova', 'Affiliation': 'Military Medical Academy, St-Petersburg, Russia.'}, {'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'Parshin', 'Affiliation': 'City Hospital No. 26, St-Petersburg, Russia.'}, {'ForeName': 'R Z', 'Initials': 'RZ', 'LastName': 'Nazhmudinov', 'Affiliation': 'Clinical Hospital of St. Luka, St-Petersburg, Russia.'}]",Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova,['10.17116/jnevro202012009137']
1727,33081446,[The assessment of the clinical efficacy and tolerability of complex treatment of patients with acute low-back pain].,"OBJECTIVE


To compare the efficacy and tolerability of different combinations of domestic generics meloxicam (amelotex), tolperisone (calmirex) and B vitamins (compligam B) in the treatment of acute low-back pain.
MATERIAL AND METHODS


Ninety patients with acute low-back pain (ICD-10 M54.5) were studied. Indications and prescribing of the drugs was carried out under the international generic name. Pain was assessed using a visual analog pain scale in mm (VAS). To relieve pain, all patients received the non-steroidal anti-inflammatory drug with a favorable safety profile meloxicam (amelotex). With the aim of optimization, 3 therapy regimens were proposed: group 1 ( n =30) received amelotex, calmirex, and B vitamins (compligam B). Group 2 ( n =30) received amelotex and calmirex. Group 3 ( n =30) was treated with amelotex and compligam B. With a decrease in pain by 50% or more from the baseline level and a VAS <40 mm, patients could reduce the dose of amelotex from 15 to 7.5 mg or stop taking it.
RESULTS


During treatment, all groups showed a significant regression of pain according to VAS: in group 1 from 77 to 9 mm, in group 2 from 74 to 12 mm, in group 3 from 69 to 14 mm. The maximum statistically significant reduction in pain and the degree of muscle tone was observed in group 1. Adverse reactions occurred in all groups, but they were weak and transient, and did not require correction or discontinuation of therapy. Only one patient from group 3 had a persistent rise in blood pressure. The average duration of temporary disability was 5.8 days in group 1, 7.4 in group 2, and 9.5 days in group 3. High efficacy and good tolerability of all 3 therapy regimens were noted. The combination of amelotex, calmirex and compligam B received the highest rating in the opinion of doctors and patients.
CONCLUSION


All 3 treatment regimens optimize therapy in patients with acute low-back pain, reduce the dose and timing of the NSAID administration as well as the risk of adverse reactions. The results indicate that the combination of amelotex, calmirex and compligam B is a synergy of three pain relief systems due to the effect on different pathogenetic mechanisms, thereby providing the maximum analgesic effect, shortening the course of treatment and duration of temporary disability, reducing the risk of relapse and chronicity of pain.",2020,"Adverse reactions occurred in all groups, but they were weak and transient, and did not require correction or discontinuation of therapy.","['Ninety patients with acute low-back pain (ICD-10 M54.5', 'patients with acute low-back pain', 'acute low-back pain']","['domestic generics meloxicam (amelotex), tolperisone (calmirex) and B vitamins (compligam B', 'amelotex and calmirex', 'meloxicam (amelotex', 'amelotex, calmirex, and B vitamins (compligam B', 'amelotex and compligam B']","['clinical efficacy and tolerability', 'average duration of temporary disability', 'visual analog pain scale', 'pain and the degree of muscle tone', 'blood pressure', 'High efficacy and good tolerability', 'Pain', 'Adverse reactions', 'pain according to VAS', 'efficacy and tolerability', 'pain']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0457950', 'cui_str': 'Acute low back pain'}, {'cui': 'C1137110', 'cui_str': 'ICD-10'}]","[{'cui': 'C0003063', 'cui_str': 'Domestic Animals'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C0083381', 'cui_str': 'meloxicam'}, {'cui': 'C0040382', 'cui_str': 'Tolperisone'}, {'cui': 'C0042849', 'cui_str': 'Vitamin B Complex'}]","[{'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205374', 'cui_str': 'Transitory'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0026841', 'cui_str': 'Muscle Tension'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}]",90.0,0.0386491,"Adverse reactions occurred in all groups, but they were weak and transient, and did not require correction or discontinuation of therapy.","[{'ForeName': 'M N', 'Initials': 'MN', 'LastName': 'Dadasheva', 'Affiliation': 'Vladimirsky Moscow Regional Research Clinical Institute, Moscow, Russia.'}, {'ForeName': 'R V', 'Initials': 'RV', 'LastName': 'Gorenkov', 'Affiliation': 'Semashko National Research Institute of Public Health, Moscow, Russia.'}, {'ForeName': 'I A', 'Initials': 'IA', 'LastName': 'Zolotovskaya', 'Affiliation': 'Samara State Medical University, Samara, Russia.'}, {'ForeName': 'K N', 'Initials': 'KN', 'LastName': 'Dadasheva', 'Affiliation': 'Vladimirsky Moscow Regional Research Clinical Institute, Moscow, Russia.'}]",Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova,['10.17116/jnevro202012009147']
1728,33081449,[The double-blind randomized placebo-controlled trial of N-acetylcysteine use in schizophrenia: preliminary results].,"BACKGROUND


Currently, oxidative stress as part of the pathogenesis of schizophrenia attracts much attention. In this regard, it becomes relevant to assess the level of redox imbalance in patients with schizophrenia, its impact on existing symptoms and the possibility of its treatment. The antioxidant N-acetylcysteine is one of the potential drugs that affects oxidative stress.
OBJECTIVE


To study the possibilities of the use of N-acetylcysteine in patients with schizophrenia.
MATERIAL AND METHODS


The study included 20 patients diagnosed with paranoid schizophrenia with the disease duration of less than 3 years, randomly assigned to the main group (taking N-acetylcysteine at a dose of 2000 mg per day for 60 days) and a comparison group (placebo) in a double-blinded manner. At the beginning and end of the study, cognitive functions were evaluated using the specialized instrument BACS, the severity of psychopathological symptoms was evaluated using PANSS, and blood was collected to determine the level of glutathione (GSH), which is a metabolite of N-acetylcysteine.
RESULTS


There was a significant decrease in positive PANSS score ( p =0.013), negative PANSS score ( p =0.002) and the general pathology PANSS score ( p =0.004) in the main group. Compared with the comparison group, the dynamics of the negative PANSS score ( p =0.005) and the general psychopathology PANSS score ( p =0.004) was significantly different. When assessing the dynamics of cognitive functions in the main group, a significant improvement in indicators was established in the task for a sequence of numbers that characterizes working memory ( p =0.037). The level of GSH significantly increased in the main group ( p =0.01), however, there were no statistically significant differences between groups at the final visit.
CONCLUSION


N-acetylcysteine has a positive effect on the negative, general psychopathology PANSS scores, some cognitive functions, in particular, working memory, that allows considering this drug as a promising method of augmentation of schizophrenia therapy and requires further attentive study.",2020,"There was a significant decrease in positive PANSS score ( p =0.013), negative PANSS score ( p =0.002) and the general pathology PANSS score ( p =0.004) in the main group.","['20 patients diagnosed with paranoid schizophrenia with the disease duration of less than 3 years', 'patients with schizophrenia', 'schizophrenia']","['N-acetylcysteine', 'placebo', 'main group (taking N-acetylcysteine at a dose of 2000 mg per day for 60 days) and a comparison group (placebo', 'antioxidant N-acetylcysteine']","['negative PANSS score', 'level of GSH', 'general psychopathology PANSS score', 'positive PANSS score', 'general pathology PANSS score', 'dynamics of cognitive functions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0036349', 'cui_str': 'Paranoid schizophrenia'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}]","[{'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}]","[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0420637', 'cui_str': 'General pathology'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",20.0,0.0952515,"There was a significant decrease in positive PANSS score ( p =0.013), negative PANSS score ( p =0.002) and the general pathology PANSS score ( p =0.004) in the main group.","[{'ForeName': 'A S', 'Initials': 'AS', 'LastName': 'Pyatoykina', 'Affiliation': 'Clinical Psychiatric Hospital No. 1, Nizhny Novgorod, Russia.'}, {'ForeName': 'T V', 'Initials': 'TV', 'LastName': 'Zhilyaeva', 'Affiliation': 'Privolzhsky Research Medical University, Nizhny Novgorod, Russia.'}, {'ForeName': 'I V', 'Initials': 'IV', 'LastName': 'Semennov', 'Affiliation': 'Privolzhsky Research Medical University, Nizhny Novgorod, Russia.'}, {'ForeName': 'G A', 'Initials': 'GA', 'LastName': 'Mishanov', 'Affiliation': 'Privolzhsky Research Medical University, Nizhny Novgorod, Russia.'}, {'ForeName': 'A S', 'Initials': 'AS', 'LastName': 'Blagonravova', 'Affiliation': 'Privolzhsky Research Medical University, Nizhny Novgorod, Russia.'}, {'ForeName': 'G E', 'Initials': 'GE', 'LastName': 'Mazo', 'Affiliation': 'Bekhterev National Medical Research Center for Psychiatry and Neurology, St. Petersburg, Russia.'}]",Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova,['10.17116/jnevro202012009166']
1729,33081476,Efficacy of modified rubber band ligation in the treatment of grade III internal hemorrhoids.,"BACKGROUND


Traditional rubber band ligation can improve the symptoms of hemorrhoids, the techniques used vary among centers and the degree of hemorrhoids may also affect the therapeutic efficacy and postoperative outcome, especially for patients with grade III hemorrhoids (hemorrhoid prolapses). This study aimed to investigate the clinical efficacy of modified rubber band ligation (MRBL) in the treatment of grade III internal hemorrhoids.
METHODS


A total of 120 patients with grade III internal hemorrhoids were randomly assigned to receive MRBL or Milligan-Morgan haemorrhoidectomy (MMH) (n=60 per group). The post-operative pain, bleeding, urine retention and feeling of anal distension were recorded, and the resting anal pressure (RAP) and post-operative recurrence rate were compared between two groups.
RESULTS


The post-operative pain, bleeding and urine retention in the MRBL group were improved significantly as compared with the MMH group (P<0.05), but the feeling of anal distension was similar between them (P>0.05). The RAP remained unchanged after MRBL, but the RAP at 1 month after surgery in the MMH group increased markedly (P<0.01) as compared with that before surgery and was significantly higher than that in the MRBL group (P<0.01). The post-operative recurrence rate was comparable between two groups (P>0.05).
CONCLUSIONS


As compared with traditional MMH, MRBL is effective to attenuate the post-operative pain and other discomforts and stabilize the RA. Thus, MRBL is an ideal choice for the treatment of grade III internal hemorrhoids.",2020,"The post-operative pain, bleeding and urine retention in the MRBL group were improved significantly as compared with the MMH group (P<0.05), but the feeling of anal distension was similar between them (P>0.05).","['120 patients with grade III internal hemorrhoids', 'patients with grade III hemorrhoids (hemorrhoid prolapses', 'grade III internal hemorrhoids']","['modified rubber band ligation', 'MRBL or Milligan-Morgan haemorrhoidectomy (MMH', 'MRBL', 'MMH', 'modified rubber band ligation (MRBL']","['resting anal pressure (RAP) and post-operative recurrence rate', 'post-operative pain, bleeding and urine retention', 'feeling of anal distension', 'post-operative recurrence rate', 'post-operative pain, bleeding, urine retention and feeling of anal distension', 'RAP']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0265034', 'cui_str': 'Internal hemorrhoids'}, {'cui': 'C0019112', 'cui_str': 'Hemorrhoids'}, {'cui': 'C0239942', 'cui_str': 'Prolapsed hemorrhoids'}, {'cui': 'C0860132', 'cui_str': 'Internal hemorrhoids grade III'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0221839', 'cui_str': 'Orthodontic band, elastic'}, {'cui': 'C0023690', 'cui_str': 'Ligation'}, {'cui': 'C0582521', 'cui_str': 'Morgan'}, {'cui': 'C0019108', 'cui_str': 'Hemorrhoidectomy'}]","[{'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0003461', 'cui_str': 'Anal structure'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0080274', 'cui_str': 'Bladder retention of urine'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}]",120.0,0.0301356,"The post-operative pain, bleeding and urine retention in the MRBL group were improved significantly as compared with the MMH group (P<0.05), but the feeling of anal distension was similar between them (P>0.05).","[{'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Jin', 'Affiliation': 'Department of Coloproctology, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Haojie', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'Department of Coloproctology, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Kaijian', 'Initials': 'K', 'LastName': 'Qin', 'Affiliation': 'Department of Coloproctology, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Coloproctology, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Can', 'Initials': 'C', 'LastName': 'Cui', 'Affiliation': 'Department of Coloproctology, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Renjie', 'Initials': 'R', 'LastName': 'Wu', 'Affiliation': 'Department of Coloproctology, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Zhenyi', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Coloproctology, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China. drxinhuo@163.com.'}, {'ForeName': 'Jiong', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Coloproctology, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China. tcmoctober9@163.com.'}]",Annals of palliative medicine,['10.21037/apm-19-657']
1730,33081496,Outcomes in non-ST-segment elevation myocardial infarction patients according to heart failure at admission: Insights from a large trial with systematic early invasive strategy.,"BACKGROUND


Previous studies published before the era of systematic early invasive strategy have reported a higher mortality in non-ST-segment elevation myocardial infarction patients with heart failure. The aim of our study was to compare the clinical characteristics, outcomes and causes of death of patients according to their heart failure status at admission in a large non-ST-segment elevation myocardial infarction population with planned early invasive management.
METHODS


We performed a post-hoc analysis of the Treatment of Acute Coronary Syndrome with Otamixaban randomised trial which included non-ST-segment elevation myocardial infarction patients with systematic coronary angiography within 72 h. Patients were categorised according to presence or absence of heart failure (Killip grade ≥2) at admission.
RESULTS


A total of 13,172 patients were enrolled, of whom 944 (7.2%) had heart failure. At day 30, death occurred in 213 patients (1.6%) and cardiovascular death was the dominant cause of death in both groups ((with vs without heart failure) 78.8% vs 78.4%,  p  = 0.94). At six months, death occurred in 90/944 (9.5%) patients with heart failure and 258/12228 patients without heart failure (2.1%) ( p  < 0.001). After adjustment on Global Registry of Acute Coronary Events risk score, heart failure was an independent predictor of all-cause mortality at day 30 (odds ratio: 1.58; 95% confidence interval, 1.06-2.36,  p  = 0.02) and at day 180 (odds ratio: 1.77; 95% confidence interval, 1.3-2.42,  p  < 0.001) as well as of ischaemic complications (cardiovascular death, myocardial infarction, stent thrombosis or stroke at day 30 (odds ratio: 1.28; 95% confidence interval, 1.01-1.62,  p  = 0.04).
CONCLUSION


Non-ST-segment elevation myocardial infarction patients with heart failure at admission still have worse outcomes than those without heart failure, even with systematic early invasive strategy. Further efforts are needed to improve the prognosis of these high risk patients.",2020,"After adjustment on Global Registry of Acute Coronary Events risk score, heart failure was an independent predictor of all-cause mortality at day 30 (odds ratio: 1.58; 95% confidence interval, 1.06-2.36,  p  = 0.02) and at day 180 (odds ratio: 1.77; 95% confidence interval, 1.3-2.42,  p  < 0.001) as well as of ischaemic complications (cardiovascular death, myocardial infarction, stent thrombosis or stroke at day 30 (odds ratio: 1.28; 95% confidence interval, 1.01-1.62,  p  = 0.04).
","['patients according to their heart failure status at admission in a large non-ST-segment elevation myocardial infarction population with planned early invasive management', 'non-ST-segment elevation myocardial infarction patients according to heart failure at admission', 'A total of 13,172 patients were enrolled, of whom 944 (7.2%) had heart failure', 'myocardial infarction patients with heart failure', 'Acute Coronary Syndrome with Otamixaban randomised trial which included non-ST-segment elevation myocardial infarction patients with systematic coronary angiography within 72 h. Patients were categorised according to presence or absence of heart failure (Killip grade ≥2) at admission']",[],"['Global Registry of Acute Coronary Events risk score, heart failure', 'death', 'heart failure', 'ischaemic complications (cardiovascular death, myocardial infarction, stent thrombosis or stroke', 'cardiovascular death']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C1536221', 'cui_str': 'Non ST segment elevation myocardial infarction'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517857', 'cui_str': '7.2'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C1097497', 'cui_str': 'otamixaban'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0441800', 'cui_str': 'Grade'}]",[],"[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]",13172.0,0.131281,"After adjustment on Global Registry of Acute Coronary Events risk score, heart failure was an independent predictor of all-cause mortality at day 30 (odds ratio: 1.58; 95% confidence interval, 1.06-2.36,  p  = 0.02) and at day 180 (odds ratio: 1.77; 95% confidence interval, 1.3-2.42,  p  < 0.001) as well as of ischaemic complications (cardiovascular death, myocardial infarction, stent thrombosis or stroke at day 30 (odds ratio: 1.28; 95% confidence interval, 1.01-1.62,  p  = 0.04).
","[{'ForeName': 'Batric', 'Initials': 'B', 'LastName': 'Popovic', 'Affiliation': 'Université de Lorraine, CHRU de Nancy, Département de cardiologie, Nancy, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Sorbets', 'Affiliation': 'Université de Paris, puis APHP, Hotel Dieu, Centre de diagnostic et de Thérapeutique; French Alliance for Cardiovascular Trials (FACT); INSERM LVTS-U1148.'}, {'ForeName': 'Jeremie', 'Initials': 'J', 'LastName': 'Abtan', 'Affiliation': 'Université de Paris, puis APHP, Hotel Dieu, Centre de diagnostic et de Thérapeutique; French Alliance for Cardiovascular Trials (FACT); INSERM LVTS-U1148.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Cohen', 'Affiliation': 'APHP, Department of cardiology, Hôpital Bichat, France; French Alliance for Cardiovascular Trials (FACT); INSERM LVTS-U1148; DHU FIRE, University of Paris.'}, {'ForeName': 'Charles V', 'Initials': 'CV', 'LastName': 'Pollack', 'Affiliation': 'Division of Cardiology, Newark Beth Israel Medical Center, Mount Sinai School of Medicine, Newark, New Jersey, USA.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Bode', 'Affiliation': 'Sidney Kimmel Medical College, USA.'}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Wiviott', 'Affiliation': 'Medizinische Universitatsklinik, Freiburg, Germany.'}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Sabatine', 'Affiliation': 'Medizinische Universitatsklinik, Freiburg, Germany.'}, {'ForeName': 'Shamir R', 'Initials': 'SR', 'LastName': 'Mehta', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Witold', 'Initials': 'W', 'LastName': 'Ruzyllo', 'Affiliation': 'Institute of Cardiology, Warsaw, Poland.'}, {'ForeName': 'Sunil V', 'Initials': 'SV', 'LastName': 'Rao', 'Affiliation': 'The Duke Clinical Research Institute, Durham, North Carolina, USA.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'French', 'Affiliation': 'David Geffen School of Medicine at UCLA, Torrance, California, USA.'}, {'ForeName': 'Prafulla', 'Initials': 'P', 'LastName': 'Kerkar', 'Affiliation': 'Seth GS Medical College, India.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Kiss', 'Affiliation': 'Department of Cardiology, Military Hospital, Budapest, Hungary.'}, {'ForeName': 'Jose Luis N', 'Initials': 'JLN', 'LastName': 'Estrada', 'Affiliation': 'Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.'}, {'ForeName': 'Yedid', 'Initials': 'Y', 'LastName': 'Elbez', 'Affiliation': 'Université de Paris, puis APHP, Hotel Dieu, Centre de diagnostic et de Thérapeutique; French Alliance for Cardiovascular Trials (FACT); INSERM LVTS-U1148.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Ducrocq', 'Affiliation': 'Université de Paris, puis APHP, Hotel Dieu, Centre de diagnostic et de Thérapeutique; French Alliance for Cardiovascular Trials (FACT); INSERM LVTS-U1148.'}, {'ForeName': 'Philippe Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'Université de Paris, puis APHP, Hotel Dieu, Centre de diagnostic et de Thérapeutique; French Alliance for Cardiovascular Trials (FACT); INSERM LVTS-U1148.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European heart journal. Acute cardiovascular care,['10.1177/2048872619896205']
1731,33081505,Impact of exergames on psychiatric symptoms in older adults with serious mental illness.,"OBJECTIVES


Older adults with serious mental illness (SMI) are more likely to have high body mass index (BMI) and chronic conditions such as cardiovascular disease and diabetes. A sedentary lifestyle, which may be attributed to pharmacologic side effects and the symptoms of mental illness, has been difficult to treat. Patients experiencing negative symptoms (e.g. apathy, anhedonia) may be more likely to exercise in a group setting with activities that are designed to stimulate the mind and encourage engagement. ""Exergames,"" or exercise-based videogames, are an interactive and stimulating method to provide aerobic activities. Exercise has also been shown to reduce the symptoms of depression. The purpose of this study is to evaluate the impact of a 10-week exergame program on depressive and negative symptoms in older adults with SMI.
MATERIALS AND METHODS


A single-group pretest posttest study was conducted with 52 older adults diagnosed with SMI. Participants engaged in group exergame activities for 50-minute sessions three times a week for 10 weeks. The Patient Reported Outcome Measurement Information System (PROMIS) and the Scale for the Assessment of Negative Symptoms (SANS) were conducted at enrollment, 5 weeks, and 10 weeks.
RESULTS


Participants achieved statistically significant reductions in self-reported depressive symptoms (-0.83, LL -1.46, UL -0.12) and observed negative symptoms (-5.29, LL -7.67, UL -3.14) over a 10-week period.
CONCLUSIONS


Our results suggest utilization of exergames as an adjunct treatment can be an effective, engaging, and cost-efficient method to reducing depressive and negative symptoms in older adults with SMI.",2020,"RESULTS


Participants achieved statistically significant reductions in self-reported depressive symptoms (-0.83, LL -1.46, UL -0.12) and observed negative symptoms (-5.29, LL -7.67, UL -3.14) over a 10-week period.
","['Patients experiencing negative symptoms (e.g. apathy, anhedonia', 'older adults with SMI', 'Older adults with serious mental illness (SMI', 'older adults with serious mental illness', '52 older adults diagnosed with SMI']",['exergame program'],"['self-reported depressive symptoms', 'Outcome Measurement Information System (PROMIS) and the Scale for the Assessment of Negative Symptoms (SANS', 'psychiatric symptoms', 'depressive and negative symptoms', 'negative symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0085632', 'cui_str': 'Indifference'}, {'cui': 'C0178417', 'cui_str': 'Anhedonia'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0021428', 'cui_str': 'Information system'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0233401', 'cui_str': 'Psychiatric symptom'}]",52.0,0.0877167,"RESULTS


Participants achieved statistically significant reductions in self-reported depressive symptoms (-0.83, LL -1.46, UL -0.12) and observed negative symptoms (-5.29, LL -7.67, UL -3.14) over a 10-week period.
","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Heinbach', 'Affiliation': 'UCSF Medical Center, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Block', 'Affiliation': 'Department of Physiological Nursing, School of Nursing, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Hubbard', 'Affiliation': 'Department of Physiological Nursing, School of Nursing, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Janine', 'Initials': 'J', 'LastName': 'Cataldo', 'Affiliation': 'Department of Physiological Nursing, School of Nursing, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Cooper', 'Affiliation': 'Department of Physiological Nursing, School of Nursing, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Leutwyler', 'Affiliation': 'Department of Physiological Nursing, School of Nursing, University of California San Francisco, San Francisco, CA, USA.'}]",Aging & mental health,['10.1080/13607863.2020.1832442']
1732,33081502,Rationale and design of the LIBERATES trial: Protocol for a randomised controlled trial of flash glucose monitoring for optimisation of glycaemia in individuals with type 2 diabetes and recent myocardial infarction.,"Hyperglycaemia in individuals with type 2 diabetes (T2D) and myocardial infarction (MI) is associated with guarded clinical prognosis. Studies improving glucose levels in T2D following MI relied on HbA1c as the main glycaemic marker, failing to address potential adverse effects of hypoglycaemia and glucose variability. We describe the design of the LIBERATES trial that investigates the role of flash glucose monitoring in optimising glycaemic markers in high vascular risk individuals with T2D. This multicentre trial is designed to recruit up to 150 insulin and/or sulphonylurea-treated T2D patients, within 5 days of a proven MI. Individuals will be randomised 1:1 into intervention and control groups using flash glucose monitoring sensors and traditional self-monitoring of blood glucose, respectively. The control group will also wear a blinded continuous glucose monitoring sensor. The primary outcome is the difference in time spent in euglycaemia (defined as glucose levels between 3.9-10.0 mmol/l), comparing study groups 3 months following recruitment, assessed daily for 14 days and as an average. Secondary and exploratory end points include time spent in hypoglycaemia and hyperglycaemia, HbA1c, quality of life measures, major adverse cardiac events and cost-effectiveness of the intervention. This study will establish the role of flash glucose monitoring in glycaemic management of individuals with T2D sustaining a cardiac event.(Trial Registration: ISRCTN14974233, registered 12th June 2017).",2020,Hyperglycaemia in individuals with type 2 diabetes (T2D) and myocardial infarction (MI) is associated with guarded clinical prognosis.,"['individuals with type 2 diabetes (T2D) and myocardial infarction (MI', 'individuals with T2D sustaining a cardiac event.(Trial Registration', 'high vascular risk individuals with T2D', '150 insulin and/or sulphonylurea-treated T2D patients, within 5\u2009days of a proven MI', 'individuals with type 2 diabetes and recent myocardial infarction']",['flash glucose monitoring'],"['Hyperglycaemia', 'time spent in euglycaemia (defined as glucose levels', 'time spent in hypoglycaemia and hyperglycaemia, HbA1c, quality of life measures, major adverse cardiac events and cost-effectiveness of the intervention']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0038766', 'cui_str': 'Sulfonylurea'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1998297', 'cui_str': 'Recent myocardial infarction'}]","[{'cui': 'C0085635', 'cui_str': 'Photopsia'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}]","[{'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",,0.0771015,Hyperglycaemia in individuals with type 2 diabetes (T2D) and myocardial infarction (MI) is associated with guarded clinical prognosis.,"[{'ForeName': 'Colin C', 'Initials': 'CC', 'LastName': 'Everett', 'Affiliation': 'Clinical Trials Research Unit, University of Leeds, Leeds, West Yorkshire, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Reynolds', 'Affiliation': 'Clinical Trials Research Unit, University of Leeds, Leeds, West Yorkshire, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Fernandez', 'Affiliation': 'Clinical Trials Research Unit, University of Leeds, Leeds, West Yorkshire, UK.'}, {'ForeName': 'Deborah D', 'Initials': 'DD', 'LastName': 'Stocken', 'Affiliation': 'Clinical Trials Research Unit, University of Leeds, Leeds, West Yorkshire, UK.'}, {'ForeName': 'Linda D', 'Initials': 'LD', 'LastName': 'Sharples', 'Affiliation': 'London School of Hygiene and Tropical Medicine, University of London, Bloomsbury, London, UK.'}, {'ForeName': 'Thozhukat', 'Initials': 'T', 'LastName': 'Sathyapalan', 'Affiliation': 'Hull Work Medical School, University of Hull, Hull, East Yorkshire, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Heller', 'Affiliation': 'Department of Oncology and Metabolism, Sheffield Teaching Hospitals Trust, Sheffield, South Yorkshire, UK.'}, {'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Storey', 'Affiliation': 'Department of Infection, Immunity and Cardiovascular Disease, University of Sheffield, Sheffield, South Yorkshire, UK.'}, {'ForeName': 'Ramzi A', 'Initials': 'RA', 'LastName': 'Ajjan', 'Affiliation': 'Leeds Institute for Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, West Yorkshire, UK.'}]",Diabetes & vascular disease research,['10.1177/1479164120957934']
1733,33081531,Effect of Empagliflozin on the Clinical Stability of Patients with Heart Failure and a Reduced Ejection Fraction: The EMPEROR-Reduced Trial.,"Background:  Empagliflozin reduces the risk of cardiovascular death or hospitalization for heart failure in patients with heart failure and a reduced ejection fraction, with or without diabetes, but additional data are needed about the effect of the drug on inpatient and outpatient events that reflect worsening heart failure.  Methods:  We randomly assigned 3730 patients with class II-IV heart failure with an ejection fraction of ≤40% to double-blind treatment with placebo or empagliflozin (10 mg once daily), in addition to recommended treatments for heart failure, for a median of 16 months. We prospectively collected information on inpatient and outpatient events reflecting worsening heart failure and prespecified their analysis in individual and composite endpoints.  Results:  Empagliflozin reduced the combined risk of death, hospitalization for heart failure or an emergent/urgent heart failure visit requiring intravenous treatment (415 vs 519 patients; empagliflozin vs placebo, respectively; hazard ratio 0.76, 95% CI: 0.67-0.87), P <0.0001. This benefit reached statistical significance at 12 days after randomization. Empagliflozin reduced the total number of heart failure hospitalizations that required intensive care (hazard ratio 0.67, 95% CI 0.50-0.90, P=0.008) and that required a vasopressor or positive inotropic drug or mechanical or surgical intervention (hazard ratio 0.64, 95% CI: 0.47-0.87, P=0.005). As compared with placebo, fewer patients in the empagliflozin group reported intensification of diuretics (297 vs 414), hazard ratio 0.67, 95% CI: 0.56-0.78, P<0.0001. Additionally, patients assigned to empagliflozin were 20-40% more likely to experience an improvement in NYHA functional class and were 20-40% less likely to experience worsening of NYHA functional class, with statistically significant effects that were apparent 28 days after randomization and maintained during long-term follow-up. The risk of any inpatient or outpatient worsening heart failure event in the placebo group was high (48.1 per 100 patient-years of follow-up), and it was reduced by empagliflozin (hazard ratio 0.70, 95% CI: 0.63-0.78), P<0.0001.  Conclusions:  In patients with heart failure and a reduced ejection fraction, empagliflozin reduced the risk and total number of inpatient and outpatient worsening heart failure events, with benefits seen early after initiation of treatment and sustained for the duration of double-blind therapy.  Clinical Trial Registration:  URL: https://clinicaltrials.gov Unique Identifier: NCT03057977.",2020,"Empagliflozin reduced the combined risk of death, hospitalization for heart failure or an emergent/urgent heart failure visit requiring intravenous treatment (415 vs 519 patients; empagliflozin vs placebo, respectively; hazard ratio 0.76, 95% CI: 0.67-0.87), P <0.0001.","['patients with heart failure and a reduced ejection fraction', '3730 patients with class II-IV heart failure with an ejection fraction of ≤40% to double-blind treatment with', 'patients with heart failure and a reduced ejection fraction, with or without diabetes', 'Patients with Heart Failure and a Reduced Ejection Fraction']","['empagliflozin', 'placebo or empagliflozin', 'placebo', 'Empagliflozin', 'empagliflozin vs placebo']","['NYHA functional class', 'risk of any inpatient or outpatient worsening heart failure event', 'combined risk of death, hospitalization for heart failure or an emergent/urgent heart failure visit requiring intravenous treatment', 'intensification of diuretics', 'risk and total number of inpatient and outpatient worsening heart failure events', 'total number of heart failure hospitalizations']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0441886', 'cui_str': 'Class 2'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1275491', 'cui_str': 'New York Heart Association Classification'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0012798', 'cui_str': 'Diuretic'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",3730.0,0.565204,"Empagliflozin reduced the combined risk of death, hospitalization for heart failure or an emergent/urgent heart failure visit requiring intravenous treatment (415 vs 519 patients; empagliflozin vs placebo, respectively; hazard ratio 0.76, 95% CI: 0.67-0.87), P <0.0001.","[{'ForeName': 'Milton', 'Initials': 'M', 'LastName': 'Packer', 'Affiliation': ''}, {'ForeName': 'Stefan D', 'Initials': 'SD', 'LastName': 'Anker', 'Affiliation': 'Department of Cardiology (CVK), and Berlin Institute of Health Center for Regenerative Therapies, German Centre for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin, Germany.'}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Butler', 'Affiliation': 'Department of Medicine, University of Mississippi School of Medicine, Jackson, MS.'}, {'ForeName': 'Gerasimos S', 'Initials': 'GS', 'LastName': 'Filippatos', 'Affiliation': 'National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens, Greece.'}, {'ForeName': 'João Pedro', 'Initials': 'JP', 'LastName': 'Ferreira', 'Affiliation': 'Université de Lorraine, Inserm INI-CRCT, CHRU, Nancy, France.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Pocock', 'Affiliation': 'Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London UK.'}, {'ForeName': 'Peter E', 'Initials': 'PE', 'LastName': 'Carson', 'Affiliation': 'Washington DC Veterans Affairs Medical Center, Washington DC.'}, {'ForeName': 'Inder S', 'Initials': 'IS', 'LastName': 'Anand', 'Affiliation': 'Department of Cardiology, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Wolfram', 'Initials': 'W', 'LastName': 'Doehner', 'Affiliation': 'Department of Cardiology (CVK), and Berlin Institute of Health Center for Regenerative Therapies, German Centre for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Haass', 'Affiliation': 'Theresienkrankenhaus and St.Hedwig-Klinik, Mannheim, Germany.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Komajda', 'Affiliation': 'Department of Cardiology, Hospital Saint Joseph, Paris, France.'}, {'ForeName': 'Alan B', 'Initials': 'AB', 'LastName': 'Miller', 'Affiliation': 'University of Florida, Jacksonville, FL.'}, {'ForeName': 'Steen', 'Initials': 'S', 'LastName': 'Pehrson', 'Affiliation': 'Department of Cardiology, University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Teerlink', 'Affiliation': 'Section of Cardiology, San Francisco Veterans Affairs Medical Center and School of Medicine, University of California, San Diego, CA.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Brueckmann', 'Affiliation': 'Boehringer Ingelheim International GmbH and Faculty of Medicine Mannheim, University of Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Waheed', 'Initials': 'W', 'LastName': 'Jamal', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Cordula', 'Initials': 'C', 'LastName': 'Zeller', 'Affiliation': 'Biostatistics and Data Sciences, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Schnaidt', 'Affiliation': 'Biostatistics and Data Sciences, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany.'}, {'ForeName': 'Faiez', 'Initials': 'F', 'LastName': 'Zannad', 'Affiliation': 'Université de Lorraine, Inserm INI-CRCT, CHRU, Nancy, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation,['10.1161/CIRCULATIONAHA.120.051783']
1734,33081550,"The effects of kangaroo mother care and music listening on physiological parameters, oxygen saturation, crying, awake state and sleep in infants in NICU.","OBJECTIVE


Kangaroo mother care and musical stimulation are recommended nursing interventions in the NICU. However, there is little research on the combination of kangaroo care with musical stimulation and their relationship with the health condition of infants. The aim of the study was to compare the parameters of the physiological state and behavior of infants during kangaroo mother care as well as kangaroo mother care and musical stimulation.
STUDY DESIGN


The study included 100 infants, with corrected gestational ages of 35 weeks, with an average body weight of 2704 g. During kangaroo care the child was supported by their parent, then musical stimulation was added to kangaroo care. Measurements were made in an incubator after the 1st and the 15th minute of each intervention.
RESULTS


Neonatal parameters differed in the incubator and during each intervention. During kangaroo care and kangaroo care and musical stimulation, heart rate ( p  < .0001), respiration rate ( p  < .0001), crying ( p  < .0001) and awake state ( p  < .0001) decreased, oxygen saturation levels ( p  < .0001) and the number of children who fell asleep ( p  < .0001) increased. During kangaroo care and musical stimulation significantly fewer children were awake ( p  = .0003) and more fell asleep ( p  < .0001) than after kangaroo care alone ( p  < .0001).
CONCLUSIONS


This study suggests that kangaroo care and kangaroo care and musical stimulation can be used to stabilize the physiological functions of infants. Kangaroo care and musical stimulation can be one of the most effective nursing interventions in the neonatal intensive care unit for the care of infants.",2020,"During kangaroo care and musical stimulation significantly fewer children were awake ( p  = .0003) and more fell asleep ( p  < .0001) than after kangaroo care alone ( p  < .0001).
","['infants in NICU', '100 infants, with corrected gestational ages of 35 weeks, with an average body weight of 2704\u2009g']","['Kangaroo care and musical stimulation', 'kangaroo care and kangaroo care and musical stimulation', 'kangaroo mother care and music listening']","['crying', 'oxygen saturation levels', 'physiological parameters, oxygen saturation, crying, awake state and sleep', 'awake state', 'heart rate', 'respiration rate', 'number of children who fell asleep', 'fell asleep']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]","[{'cui': 'C0262705', 'cui_str': 'Kangaroo care'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C1257803', 'cui_str': 'Kangaroo-Mother Care'}, {'cui': 'C0026867', 'cui_str': 'Music'}]","[{'cui': 'C0010399', 'cui_str': 'Crying'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0234422', 'cui_str': 'Awake'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0424522', 'cui_str': 'Asleep'}]",100.0,0.0239978,"During kangaroo care and musical stimulation significantly fewer children were awake ( p  = .0003) and more fell asleep ( p  < .0001) than after kangaroo care alone ( p  < .0001).
","[{'ForeName': 'Grażyna', 'Initials': 'G', 'LastName': 'Gebuza', 'Affiliation': 'Faculty of Health Sciences, Nicolaus Copernicus University in Torun, Torun, Poland.'}, {'ForeName': 'Marzena', 'Initials': 'M', 'LastName': 'Kaźmierczak', 'Affiliation': 'Faculty of Health Sciences, Nicolaus Copernicus University in Torun, Torun, Poland.'}, {'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Leńska', 'Affiliation': 'Neonatal Intensive Care Unit, University Hospital No 2, Bydgoszcz, Poland.'}]","The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians",['10.1080/14767058.2020.1836619']
1735,33081586,Supervised Valsalva Maneuver after Burr Hole Evacuation of Chronic Subdural Hematomas: a Prospective Cohort Study.,"Research on chronic subdural hematoma (cSDH) management has primarily focused on potential recurrence after surgical evacuation. Herein, we present a novel postoperative/non-invasive treatment that includes a supervised Valsalva maneuver (SVM) which may serve to reduce SDH recurrence. Accordingly, the aims of the study were to investigate the effects of SVM on SDH recurrence rates and functional outcomes. A prospective study was conducted from December 2016 until December 2019 at our institution. Of the 204 adult patients with surgically treated cSDH that had subdural drains placed, 94 patients were assigned to the SVM group and 82 patients were assigned to the control group. The SVM was performed by having patients blow into a self-made SVM-device at least 2 times/hour for 12 hours/day. The primary endpoint was SDH recurrence rate whilst secondary outcomes were morbidity and functional outcomes at 3-months of follow-up. SDH recurrence was observed in 16 of 94 patients (17%) in the SVM group which was a significant reduction as compared to the control group which had 24 of 82 patients (29.3%; p=0.05) develop recurrent SDHs. Furthermore, the infection rate (e.g.pneumonia) was significantly lower in the SVM group (1.1%) compared to the control group (13.4%; p<0.001; Odds ratio [OR] 0.1). At the 3-month follow-up, 85 of 94 patients (90.4%) achieved favorable outcomes in the SVM group compared to 62 of 82 patients (75.6%) in the control group (p=0.008; OR 3.0). Independent predictors for favorable outcome at follow-up were age (OR 0.9) and infection (OR 0.2). SVM appears to be safe and effective in the postoperative management of cSDHs, reducing both recurrence rates and infections after surgical evacuation thereby resulting in favorable outcomes at follow-up.",2020,SDH recurrence was observed in 16 of 94 patients (17%) in the SVM group which was a significant reduction as compared to the control group which had 24 of 82 patients (29.3%; p=0.05) develop recurrent SDHs.,"['204 adult patients with surgically treated cSDH that had subdural drains placed, 94 patients were assigned to the SVM group and 82 patients', 'December 2016 until December 2019 at our institution']","['SVM', 'supervised Valsalva maneuver (SVM', 'Supervised Valsalva Maneuver after Burr Hole Evacuation']","['infection rate (e.g.pneumonia', 'SDH recurrence rate', 'morbidity and functional outcomes', 'SDH recurrence rates and functional outcomes', 'SDH recurrence', 'recurrent SDHs', 'favorable outcomes']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0749095', 'cui_str': 'Subdural Hematoma, Chronic'}, {'cui': 'C0038541', 'cui_str': 'Subdural space structure'}, {'cui': 'C0013103', 'cui_str': 'Drainage procedure'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0042293', 'cui_str': 'Valsalva maneuver'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}]","[{'cui': 'C0042293', 'cui_str': 'Valsalva maneuver'}, {'cui': 'C0040836', 'cui_str': 'Trephination of cranium'}, {'cui': 'C1282573', 'cui_str': 'Evacuation procedure'}]","[{'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0018946', 'cui_str': 'Subdural hematoma'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}]",204.0,0.0287251,SDH recurrence was observed in 16 of 94 patients (17%) in the SVM group which was a significant reduction as compared to the control group which had 24 of 82 patients (29.3%; p=0.05) develop recurrent SDHs.,"[{'ForeName': 'Sae-Yeon', 'Initials': 'SY', 'LastName': 'Won', 'Affiliation': 'Goethe-Universitat Frankfurt am Main Fachbereich 16 Medizin, 144867, Neurosurgery, Schleusenweg, 2-16, Frankfurt am Main, Germany, 60590; sae-yeon.won@kgu.de.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Dubinski', 'Affiliation': 'Goethe-Universitat Frankfurt am Main, 9173, Neurosurgery, Frankfurt am Main, Hessen, Germany; daniel.dubinski@kgu.de.'}, {'ForeName': 'Bedjan', 'Initials': 'B', 'LastName': 'Behmanesh', 'Affiliation': 'Hospital of the Goethe University Frankfurt, 14984, Neurosurgery, Frankfurt am Main, Hessen, Germany; bedjan.behmanesh@kgu.de.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Bernstock', 'Affiliation': ""Brigham and Women's Hospital, 1861, Neurosurgery, Boston, Massachusetts, United States; jbernstock@gmail.com.""}, {'ForeName': 'Fee', 'Initials': 'F', 'LastName': 'Keil', 'Affiliation': 'Hospital of the Goethe University Frankfurt, 14984, Neuroradiology, Frankfurt am Main, Hessen, Germany; fee.keil@kgu.de.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Freiman', 'Affiliation': 'Goethe-Universitat Frankfurt am Main, 9173, Neurosurgery, Frankfurt am Main, Hessen, Germany; thomas.freiman@med.uni-rostock.de.'}, {'ForeName': 'Juergen', 'Initials': 'J', 'LastName': 'Konczalla', 'Affiliation': 'Goethe-Universitat Frankfurt am Main, 9173, Neurosurgery, Frankfurt am Main, Hessen, Germany; J.konczalla@med.uni-frankfurt.de.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Seifert', 'Affiliation': 'Goethe-Universitat Frankfurt am Main, 9173, Neurosurgery, Frankfurt am Main, Hessen, Germany; Volker.Seifert@kgu.de.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Gessler', 'Affiliation': 'Hospital of the Goethe University Frankfurt, 14984, Neurosurgery, Frankfurt am Main, Hessen, Germany; florian.gessler@kgu.de.'}]",Journal of neurotrauma,['10.1089/neu.2020.7391']
1736,33081596,A nutritional web-based approach in obesity and diabetes before and during COVID-19 lockdown.,"INTRODUCTION


Obesity and type 2 diabetes (T2D) are two closely related pandemic conditions. Novel technologies represent promising tools for their management, the use of which has been greatly encouraged during the COVID-19 pandemic. The aim of the present study is to compare a web-based nutritional intervention versus a traditional one, before and during the Italian 'lockdown' period due to the COVID-19 outbreak, in overweight and obese subjects affected by T2D or impaired glucose regulation (IGR).
METHODS


For the study, 36 subjects were randomly allocated into two arms: a  traditional  arm, providing face-to-face individual and group-based intervention; and a  web  arm, deploying the in-presence traditional approach with intervention provided through web technologies. The outcomes were the data resulting from the comparison between the subjects' anthropometric and clinical parameters as well as PREDIMED scores at baseline with those at 3 months (T3), 6 months (T6) and at lockdown.
RESULTS


In the  web  arm we detected a progressive reduction in weight and body mass index (BMI) from baseline to T6 and a minimal increase of both parameters during the lockdown. Improvement of these parameters compared with baseline was observed in controls during the lockdown. The PREDIMED score improved at T6 compared with baseline in both arms. Significant variations were observed considering weight ( p  < 0.001), BMI ( p  = 0.001) and PREDIMED scores ( p  = 0.023) over time.
DISCUSSION


The study showed the effectiveness and feasibility of a short-term nutritional web-based intervention in patients affected by T2D or IGR before and during the COVID 19 pandemic. Clinical Trial registration number:  NCT04386200, ClinicalTrials.gov.",2020,"Significant variations were observed considering weight ( p  < 0.001), BMI ( p  = 0.001) and PREDIMED scores ( p  = 0.023) over time.
","['36 subjects', 'overweight and obese subjects affected by T2D or impaired glucose regulation (IGR', 'patients affected by T2D or IGR before and during the COVID 19 pandemic']","['short-term nutritional web-based intervention', 'traditional  arm, providing face-to-face individual and group-based intervention; and a  web  arm, deploying the in-presence traditional approach with intervention provided through web technologies']","['BMI', 'progressive reduction in weight and body mass index (BMI', 'effectiveness and feasibility']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0522476', 'cui_str': 'Patient affected'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1615608', 'cui_str': 'Pandemics'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C3898714', 'cui_str': 'Internet Intervention'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",36.0,0.0359143,"Significant variations were observed considering weight ( p  < 0.001), BMI ( p  = 0.001) and PREDIMED scores ( p  = 0.023) over time.
","[{'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Fraticelli', 'Affiliation': 'Department of Medicine and Aging, School of Medicine and Health Sciences, ""G. d\'Annunzio"" University of Chieti-Pescara, Italy.'}, {'ForeName': 'Marta Di', 'Initials': 'MD', 'LastName': 'Nicola', 'Affiliation': 'Laboratory of Biostatistics, Department of Medical, Oral and Biotechnological Sciences, ""G. d\'Annunzio"" University of Chieti-Pescara, Italy.'}, {'ForeName': 'Ester', 'Initials': 'E', 'LastName': 'Vitacolonna', 'Affiliation': 'Department of Medicine and Aging, School of Medicine and Health Sciences, ""G. d\'Annunzio"" University of Chieti-Pescara, Italy.'}]",Journal of telemedicine and telecare,['10.1177/1357633X20966933']
1737,33081606,"Effect of once-daily fluticasone furoate/vilanterol  versus  vilanterol alone on bone mineral density in patients with COPD: a randomized, controlled trial.","BACKGROUND


The relationship between inhaled corticosteroids and bone mineral density (BMD) remains uncertain despite extensive research.
METHODS


This was an international, multicenter, randomized, double-blind, parallel-group, 3-year noninferiority study. Patients with chronic obstructive pulmonary disease (COPD) (⩾40 years of age; smoking history ⩾10 pack years) and at least one native hip evaluable for BMD were enrolled and randomized 1:1, stratified by sex, to treatment with vilanterol (VI) 25 µg or fluticasone furoate/vilanterol (FF/VI) 100 µg/25 µg. BMD measurements were taken  via  dual-energy X-ray absorptiometry every 6 months. The primary endpoint was assessment of the noninferiority of change from baseline in total hip BMD per year at the -1% noninferiority level. Change from baseline in BMD at the lumbar spine and BMD measurements by sex were secondary endpoints. Incidences of COPD exacerbations and bone fractures throughout the study were also recorded.
RESULTS


Of 283 randomized patients, 170 (60%) completed the study. Noninferiority was demonstrated for FF/VI  versus  VI with regards to change from baseline in total hip BMD per year, with changes of -0.27% and 0.18%, respectively, and a treatment difference of -0.46% per year [95% confidence interval (CI) -0.97 to 0.06]. The treatment difference for FF/VI  versus  VI regarding lumbar spine BMD was -0.51% per year (95% CI -1.11 to 0.10). COPD exacerbations and bone fracture rates were similar between treatment groups.
CONCLUSION


FF/VI showed noninferiority to VI for change from baseline in total hip BMD per year, when assessed at the -1% noninferiority margin in a combined sample of men and women with COPD. The reviews of this paper are available via the supplemental material section.",2020,"Noninferiority was demonstrated for FF/VI  versus  VI with regards to change from baseline in total hip BMD per year, with changes of -0.27% and 0.18%, respectively, and a treatment difference of -0.46% per year [95% confidence interval (CI) -0.97 to 0.06].","['Patients with chronic obstructive pulmonary disease (COPD) (⩾40\u2009years of age; smoking history ⩾10 pack years) and at least one native hip evaluable for BMD', 'patients with COPD', 'Of 283 randomized patients, 170 (60%) completed the study']","['fluticasone furoate/vilanterol  versus  vilanterol alone', 'fluticasone furoate/vilanterol (FF/VI) 100', 'vilanterol (VI) 25']","['COPD exacerbations and bone fracture rates', 'bone mineral density', 'lumbar spine BMD', 'BMD measurements', 'total hip BMD', 'Incidences of COPD exacerbations and bone fractures']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C1277691', 'cui_str': 'Pack years'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C4708786', 'cui_str': '283'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C1948374', 'cui_str': 'fluticasone furoate'}, {'cui': 'C2935023', 'cui_str': 'vilanterol'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C3508933', 'cui_str': 'Chronic obstructive pulmonary disease exacerbation'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030786', 'cui_str': 'Hip Bone'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",283.0,0.775402,"Noninferiority was demonstrated for FF/VI  versus  VI with regards to change from baseline in total hip BMD per year, with changes of -0.27% and 0.18%, respectively, and a treatment difference of -0.46% per year [95% confidence interval (CI) -0.97 to 0.06].","[{'ForeName': 'Francois', 'Initials': 'F', 'LastName': 'Maltais', 'Affiliation': 'Centre de Recherche, Institut universitaire de cardiologie et de pneumologie de Québec, 2725 Chemin Sainte Foy, Québec City, QC, G1V 4G5, Canada.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Schenkenberger', 'Affiliation': 'Klinische Forschung Berlin GbR, Berlin, Germany.'}, {'ForeName': 'Pascal L M L', 'Initials': 'PLML', 'LastName': 'Wielders', 'Affiliation': 'Department of Pulmonary Diseases, Catharina Hospital, Eindhoven, The Netherlands.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Ortiz de Saracho', 'Affiliation': 'Department of Pulmonary Diseases, El Bierzo Hospital, Ponferrada (León), Spain.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Chinsky', 'Affiliation': 'Chest Diseases of Northwestern PA, Erie, PA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Watkins', 'Affiliation': 'Respiratory Research and Development, GlaxoSmithKline plc., Research Triangle Park, NC, USA.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Millar', 'Affiliation': 'Biostatistics, GlaxoSmithKline plc., Uxbridge, UK.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Crim', 'Affiliation': 'Research and Development, GlaxoSmithKline plc., Research Triangle Park, NC, USA.'}]",Therapeutic advances in respiratory disease,['10.1177/1753466620965145']
1738,32915063,Cost-Effectiveness of an Antibacterial Envelope for Cardiac Implantable Electronic Device Infection Prevention in the US Healthcare System From the WRAP-IT Trial.,"BACKGROUND


In the WRAP-IT trial (Worldwide Randomized Antibiotic Envelope Infection Prevention), adjunctive use of an absorbable antibacterial envelope resulted in a 40% reduction of major cardiac implantable electronic device infection without increased risk of complication in 6983 patients undergoing cardiac implantable electronic device revision, replacement, upgrade, or initial cardiac resynchronization therapy defibrillator implant. There is limited information on the cost-effectiveness of this strategy. As a prespecified objective, we evaluated antibacterial envelope cost-effectiveness compared with standard-of-care infection prevention strategies in the US healthcare system.
METHODS


A decision tree model was used to compare costs and outcomes of antibacterial envelope (TYRX) use adjunctive to standard-of-care infection prevention versus standard-of-care alone over a lifelong time horizon. The analysis was performed from an integrated payer-provider network perspective. Infection rates, antibacterial envelope effectiveness, infection treatment costs and patterns, infection-related mortality, and utility estimates were obtained from the WRAP-IT trial. Life expectancy and long-term costs associated with device replacement, follow-up, and healthcare utilization were sourced from the literature. Costs and quality-adjusted life years were discounted at 3%. An upper willingness-to-pay threshold of $150 000 per quality-adjusted life year was used to determine cost-effectiveness, in alignment with the American College of Cardiology/American Heart Association practice guidelines and as supported by the World Health Organization and contemporary literature.
RESULTS


The base case incremental cost-effectiveness ratio of the antibacterial envelope compared with standard-of-care was $112 603/quality-adjusted life year. The incremental cost-effectiveness ratio remained lower than the willingness-to-pay threshold in 74% of iterations in the probabilistic sensitivity analysis and was most sensitive to the following model inputs: infection-related mortality, life expectancy, and infection cost.
CONCLUSIONS


The absorbable antibacterial envelope was associated with a cost-effectiveness ratio below contemporary benchmarks in the WRAP-IT patient population, suggesting that the envelope provides value for the US healthcare system by reducing the incidence of cardiac implantable electronic device infection. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02277990.",2020,"The absorbable antibacterial envelope was associated with a cost-effectiveness ratio below contemporary benchmarks in the WRAP-IT patient population, suggesting that the envelope provides value for the US healthcare system by reducing the incidence of cardiac implantable electronic device infection.","['6983 patients undergoing cardiac implantable electronic device revision, replacement, upgrade, or initial cardiac resynchronization therapy defibrillator implant']",['antibacterial envelope (TYRX) use adjunctive to standard-of-care infection prevention versus standard-of-care alone'],"['Infection rates, antibacterial envelope effectiveness, infection treatment costs and patterns, infection-related mortality, and utility estimates', 'Costs and quality-adjusted life years', 'mortality, life expectancy, and infection cost', 'Life expectancy and long-term costs', 'incremental cost-effectiveness ratio']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0439616', 'cui_str': 'Revisions'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C1167956', 'cui_str': 'Cardiac resynchronisation therapy'}, {'cui': 'C0180307', 'cui_str': 'Defibrillator'}]","[{'cui': 'C0279516', 'cui_str': 'Antibacterial'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}]","[{'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0279516', 'cui_str': 'Antibacterial'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0087112', 'cui_str': 'Treatment Costs'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0023671', 'cui_str': 'Life Expectancy'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",6983.0,0.0976023,"The absorbable antibacterial envelope was associated with a cost-effectiveness ratio below contemporary benchmarks in the WRAP-IT patient population, suggesting that the envelope provides value for the US healthcare system by reducing the incidence of cardiac implantable electronic device infection.","[{'ForeName': 'Bruce L', 'Initials': 'BL', 'LastName': 'Wilkoff', 'Affiliation': 'Cleveland Clinic, OH (B.L.W., K.G.T.).'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Boriani', 'Affiliation': 'University of Modena and Reggio Emilia, Modena, Italy (G.B.).'}, {'ForeName': 'Suneet', 'Initials': 'S', 'LastName': 'Mittal', 'Affiliation': 'Valley Health System, Ridgewood, NJ (S.M.).'}, {'ForeName': 'Jeanne E', 'Initials': 'JE', 'LastName': 'Poole', 'Affiliation': 'University of Washington School of Medicine, Seattle (J.E.P.).'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Kennergren', 'Affiliation': 'Sahlgrenska University Hospital, Göteborg, Sweden (C.K.).'}, {'ForeName': 'G Ralph', 'Initials': 'GR', 'LastName': 'Corey', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC (G.R.C.).'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Krahn', 'Affiliation': 'University of British Colombia, Canada (A.D.K.).'}, {'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': 'Schloss', 'Affiliation': 'The Christ Hospital, Cincinnati, OH (E.J.S.).'}, {'ForeName': 'Jose L', 'Initials': 'JL', 'LastName': 'Gallastegui', 'Affiliation': 'Clearwater Cardiovascular and Interventional Consultants, Safety Harbor, FL (J.L.G.).'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Pickett', 'Affiliation': 'Saint Thomas Research Institute, LLC, Nashville, TN (R.A.P.).'}, {'ForeName': 'Rudolph F', 'Initials': 'RF', 'LastName': 'Evonich', 'Affiliation': 'Upper Michigan Cardiovascular Associates, Marquette (R.F.E.).'}, {'ForeName': 'Steven F', 'Initials': 'SF', 'LastName': 'Roark', 'Affiliation': 'Cardiology Associates of Gainesville, FL (S.F.R.).'}, {'ForeName': 'Denise M', 'Initials': 'DM', 'LastName': 'Sorrentino', 'Affiliation': 'Iowa Heart Center, Ames (D.M.S.).'}, {'ForeName': 'Darius P', 'Initials': 'DP', 'LastName': 'Sholevar', 'Affiliation': 'Virtua Health System, Camden, NJ (D.P.S.).'}, {'ForeName': 'Edmond M', 'Initials': 'EM', 'LastName': 'Cronin', 'Affiliation': 'Temple University Hospital, Philadelphia, PA (E.M.C.).'}, {'ForeName': 'Brett J', 'Initials': 'BJ', 'LastName': 'Berman', 'Affiliation': 'Chula Vista Cardiac Center, CA (B.J.B.).'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Riggio', 'Affiliation': 'Arizona Arrhythmia Consultants, Scottsdale (D.W.R.).'}, {'ForeName': 'Hafiza H', 'Initials': 'HH', 'LastName': 'Khan', 'Affiliation': 'Baylor Research Institute, Plano, TX (H.H.K.).'}, {'ForeName': 'Marc T', 'Initials': 'MT', 'LastName': 'Silver', 'Affiliation': 'WakeMed Heart and Vascular, WakeMed Health and Hospitals, Raleigh, NC (M.T.S.).'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Collier', 'Affiliation': 'Oklahoma Heart Hospital (J.C.).'}, {'ForeName': 'Zayd', 'Initials': 'Z', 'LastName': 'Eldadah', 'Affiliation': 'MedStar Heart and Vascular Institute, Washington, DC (Z.E.).'}, {'ForeName': 'Reece', 'Initials': 'R', 'LastName': 'Holbrook', 'Affiliation': 'Medtronic, Inc, Mounds View, MN (R.H., J.D.L., D.R.L., S.S.).'}, {'ForeName': 'Jeff D', 'Initials': 'JD', 'LastName': 'Lande', 'Affiliation': 'Medtronic, Inc, Mounds View, MN (R.H., J.D.L., D.R.L., S.S.).'}, {'ForeName': 'Daniel R', 'Initials': 'DR', 'LastName': 'Lexcen', 'Affiliation': 'Medtronic, Inc, Mounds View, MN (R.H., J.D.L., D.R.L., S.S.).'}, {'ForeName': 'Swathi', 'Initials': 'S', 'LastName': 'Seshadri', 'Affiliation': 'Medtronic, Inc, Mounds View, MN (R.H., J.D.L., D.R.L., S.S.).'}, {'ForeName': 'Khaldoun G', 'Initials': 'KG', 'LastName': 'Tarakji', 'Affiliation': 'Cleveland Clinic, OH (B.L.W., K.G.T.).'}]",Circulation. Arrhythmia and electrophysiology,['10.1161/CIRCEP.120.008503']
1739,30979682,[Effectiveness and safety of two phototherapy devices for the humanised management of neonatal jaundice].,"INTRODUCTION


Neonatal jaundice is common, especially in premature infants. Compliance with treatment protocols and standard serum bilirubin curves forces the clinician to separate the child from the mother after birth for short phototherapy. The objective of this study is to evaluate the effectiveness and safety of two innovative devices for phototherapy including a LED light mesh: one sleeping bag and one blanket compared to conventional hospital or ambulatory phototherapy.
METHODS


Two randomised clinical trials were conducted: one with newborns >2,000g at birth in the Neonatal Care Unit and the other with premature infants followed-up in an outpatient clinic (PMC). The gold standard for bilirubin measurement was serum bilirubin, and ambulatory controls were performed with the Bilicheck®. Parents and health personnel completed a questionnaire on comfort and perceptions.
RESULTS


In the study using the bag, a linear regression was performed for the decrease in bilirubin in mg/dL/h, controlling by early jaundice (<36h) and the device type. The results were similar between the 2 devices. For the blanket trial in the PMC, the decrease in bilirubin levels with the new device was significantly greater with no differences in temperatures, duration of phototherapy, re-admission, mortality, or side effects for both trials. Parents and staff satisfaction with the two devices was identical for the 2 trials.
CONCLUSION


These 2 small studies add a 'grain of sand' to humanisation of newborn care, avoiding the mother-and-child separation for both the intra-hospital high-risk hyperbilirubinaemia, as well as for the lower-risk hyperbilirubinaemia in an outpatient clinic.",2020,"Parents and staff satisfaction with the two devices was identical for the 2 trials.
","['premature infants', 'Two randomised clinical trials were conducted: one with newborns >2,000g at birth in the Neonatal Care Unit and the other with premature infants followed-up in an outpatient clinic (PMC', 'neonatal jaundice']",['phototherapy devices'],"['temperatures, duration of phototherapy, re-admission, mortality, or side effects', 'bilirubin levels']","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1744681', 'cui_str': 'Congenital'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0070689', 'cui_str': 'phenylmercuric chloride'}, {'cui': 'C0022353', 'cui_str': 'Neonatal jaundice'}]","[{'cui': 'C0031765', 'cui_str': 'Light therapy'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0031765', 'cui_str': 'Light therapy'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0344395', 'cui_str': 'Bilirubin measurement'}]",,0.0383333,"Parents and staff satisfaction with the two devices was identical for the 2 trials.
","[{'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Montealegre', 'Affiliation': 'Hospital Universitario San Ignacio, Bogotá, Colombia; Pontificia Universidad Javeriana, Bogotá, Colombia; Fundación Canguro, Bogotá, Colombia. Electronic address: Montealegre.a@javeriana.edu.co.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Charpak', 'Affiliation': 'Pontificia Universidad Javeriana, Bogotá, Colombia; Fundación Canguro, Bogotá, Colombia; Programa Madre Canguro Integral, Hospital Universitario San Ignacio, Bogotá, Colombia.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Parra', 'Affiliation': 'Programa Madre Canguro Integral, Hospital Universitario San Ignacio, Bogotá, Colombia.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Devia', 'Affiliation': 'Hospital Universitario San Ignacio, Bogotá, Colombia; Pontificia Universidad Javeriana, Bogotá, Colombia.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Coca', 'Affiliation': 'Hospital Universitario San Ignacio, Bogotá, Colombia; Pontificia Universidad Javeriana, Bogotá, Colombia.'}, {'ForeName': 'Ana María', 'Initials': 'AM', 'LastName': 'Bertolotto', 'Affiliation': 'Hospital Universitario San Ignacio, Bogotá, Colombia; Pontificia Universidad Javeriana, Bogotá, Colombia.'}]","Anales de pediatria (Barcelona, Spain : 2003)",['10.1016/j.anpedi.2019.02.008']
1740,31241441,Therapeutic Value of Vitamin D as an Adjuvant Therapy in Neonates with Sepsis.,"Sepsis is unusual systemic reaction to an ordinary infection, and it probably represents a pattern of response by the immune system to the injury. Vitamin D is a fat-soluble steroid hormone that contributes to the maintenance of normal calcium homeostasis and skeletal mineralization. Vitamin D has an important role in the regulation of both innate and adaptive immune systems.
AIM OF THE WORK


The current study aimed to evaluate the therapeutic value of vitamin D supplementation as an adjuvant therapy in neonates with sepsis.
SUBJECTS AND METHOD


This study included 60 neonates with sepsis who were randomly divided into 2 equal groups; group I: 30 neonates with sepsis who received antibiotic only, Group II: 30 neonates with sepsis who received antibiotic therapy and vitamin D. This study also included 30 healthy neonates as a control group. For all patients and controls, serum level of 25 (OH) vitamin D and highly sensitive C reactive protein (hs-CRP) were immunoassayed.
RESULTS


There is no significant difference between groups I, II and controls regarding weight, gestational age, sex and mode of delivery. There were significant differences between groups I and II in sepsis score and hs-CRP after 3, 7, 10 days of treatment (p values for sepsis score were 0.009, 0.006, 0.004 respectively and for hs-CRP were 0.015, 0.001, 0.001 respectively). There was a significant difference in immature /total (I/T) ratio after 7, and 10 days of treatment (p value= 0.045, 0.025, respectively,) while there was no significant difference in immature /total (I/T) ratio after 3 days of treatment (p value = 0.624).Serum 25(OH) vitamin D levels were significantly lower in neonates with sepsis (group I and II) than the controls (p value < 0.05, while there were no significant differences between the three groups considering serum calcium and phosphorus levels (P =1.000, 1.000, respectively). Isolated organisms from blood culture in neonates with sepsis (group I and group II) were most commonly B- hemolytic streptococci, E-coli, hemophilus influenza and staphylococcus aurous. There was a significant negative correlation between hs-CRP and serum 25 (OH) vitamin in group II on entry (r = - 0.832 and P value = 0.001) and after 2 weeks (r = - 0.590 and P value = 0.021). ROC curve of specificity and sensitivity of 25 (OH) vitamin D level in prediction of early-onset neonatal sepsis showed that cutoff value of vitamin D was ≤20 ng/ml, sensitivity was 100%, specificity was 73%, positive predictive value was 73%, negative predictive value was 100% and accuracy was 87.
CONCLUSION AND RECOMMENDATION


Serum 25 (OH) vitamin D levels of neonates with the early onset neonatal sepsis were significantly lower than the healthy controls. Vitamin D supplementation improved sepsis score and decrease high levels of hs-CRP; this reflects the role of vitamin D as a target therapy for neonatal sepsis. Further studies are warranted to confirm the therapeutic value of vitamin D in neonatal sepsis.",2020,"There were significant differences between groups I and II in sepsis score and hs-CRP after 3, 7, 10 days of treatment (p values for sepsis score were 0.009, 0.006, 0.004 respectively and for hs-CRP were 0.015, 0.001, 0.001 respectively).","['neonates with sepsis', '30 healthy neonates as a control group', 'Neonates with Sepsis', '60 neonates with sepsis who were randomly divided into 2 equal groups; group I: 30 neonates with sepsis who received antibiotic only, Group II: 30 neonates with sepsis who received']","['vitamin D supplementation', 'Vitamin D', 'vitamin D', 'antibiotic therapy and vitamin D', 'Vitamin D supplementation']","['immature', 'immature /total', 'serum calcium and phosphorus levels', 'serum level of 25 (OH) vitamin D and highly sensitive C reactive protein (hs-CRP', 'ROC curve of specificity and sensitivity of 25 (OH) vitamin D level', 'Serum 25 (OH) vitamin D levels of neonates with the early onset neonatal sepsis', 'sepsis score and hs-CRP', 'negative correlation between hs-CRP and serum 25 (OH) vitamin', 'total', '25(OH) vitamin D levels', 'sepsis score']","[{'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441843', 'cui_str': 'Group I'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}]","[{'cui': 'C0205252', 'cui_str': 'Immature'}, {'cui': 'C0728876', 'cui_str': 'Serum calcium measurement'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0439822', 'cui_str': 'Highly sensitive'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0035787', 'cui_str': 'ROC Analysis'}, {'cui': 'C0036668', 'cui_str': 'Sensitivity and Specificity'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C1096452', 'cui_str': 'Early-onset neonatal sepsis'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0010101', 'cui_str': 'Correlation Studies'}, {'cui': 'C0042890', 'cui_str': 'Vitamin'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",60.0,0.0773886,"There were significant differences between groups I and II in sepsis score and hs-CRP after 3, 7, 10 days of treatment (p values for sepsis score were 0.009, 0.006, 0.004 respectively and for hs-CRP were 0.015, 0.001, 0.001 respectively).","[{'ForeName': 'Adel A', 'Initials': 'AA', 'LastName': 'Hagag', 'Affiliation': 'Pediatric Department, Faculty of Medicine, Tanta University, Egypt'}, {'ForeName': 'Mohamed S', 'Initials': 'MS', 'LastName': 'El Frargy', 'Affiliation': 'Pediatric Department, Faculty of Medicine, Tanta University, Egypt'}, {'ForeName': 'Hoassam A', 'Initials': 'HA', 'LastName': 'Houdeeb', 'Affiliation': 'Clinical Pathology Department, Faculty of Medicine, Tanta University, Egypt'}]",Infectious disorders drug targets,['10.2174/1871526519666190626141859']
1741,33073847,"Survival, Dependency, and Health-Related Quality of Life in Patients With Ruptured Intracranial Aneurysm: 10-Year Follow-up of the United Kingdom Cohort of the International Subarachnoid Aneurysm Trial.","BACKGROUND


Previous analyses of the International Subarachnoid Aneurysm Trial (ISAT) cohort have reported on clinical outcomes after treatment of a ruptured intracranial aneurysm with either neurosurgical clipping or endovascular coiling.
OBJECTIVE


To evaluate the long-term quality-adjusted life years (QALYs) gained of endovascular coiling compare to neurosurgical clipping in the UK cohort of ISAT.
METHODS


Between September 12, 1994 and May 1, 2002, patients with ruptured intracranial aneurysms who were assumed treatment equipoise were randomly allocated to either neurosurgical clipping or endovascular coiling. We followed-up 1644 patients in 22 UK neurosurgical centers for a minimum of 10 yr. Health-related quality of life (HRQoL) was collected through yearly questionnaires, measured by utilities calculated from the EQ-5D-3L. We compared HRQoL between the 2 treatment groups over a period of 10 yr. In all, 1-yr, 5-yr, and 10-yr QALYs were estimated by combining utility and survival information.
RESULTS


Higher average utility values were found in the endovascular group throughout the follow-up period, with mean differences between groups statistically significant in most years. The 10-yr QALYs were estimated to be 6.68 (95% CI: 6.45-6.90) in the coiling group and 6.32 (95% CI: 6.10-6.55) in the clipping group, respectively, a significant mean difference of 0.36 (95% CI: 0.04-0.66). A third of this mean QALYs gain was estimated to derive solely from HRQoL differences.
CONCLUSION


HRQoL after treatment of a ruptured intracranial aneurysm was better after endovascular coiling compared to neurosurgical clipping, which contributed significantly to the QALYs gained over a 10-yr period.",2020,"CONCLUSION


HRQoL after treatment of a ruptured intracranial aneurysm was better after endovascular coiling compared to neurosurgical clipping, which contributed significantly to the QALYs gained over a 10-yr period.","['Patients With Ruptured Intracranial Aneurysm', 'patients with ruptured intracranial aneurysms who were assumed treatment equipoise', 'Between September 12, 1994 and May 1, 2002', '1644 patients in 22 UK neurosurgical centers for a minimum of 10 yr']","['endovascular coiling compare to neurosurgical clipping', 'neurosurgical clipping or endovascular coiling']","['Health-related quality of life (HRQoL', 'Survival, Dependency, and Health-Related Quality of Life', 'mean QALYs gain', 'average utility values', 'long-term quality-adjusted life years']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443294', 'cui_str': 'Ruptured'}, {'cui': 'C0007766', 'cui_str': 'Intracranial aneurysm'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0702057', 'cui_str': 'Equipoise'}, {'cui': 'C0205099', 'cui_str': 'Central'}]",[],"[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0011546', 'cui_str': 'Dependency, Psychology'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]",,0.179777,"CONCLUSION


HRQoL after treatment of a ruptured intracranial aneurysm was better after endovascular coiling compared to neurosurgical clipping, which contributed significantly to the QALYs gained over a 10-yr period.","[{'ForeName': 'Xinyang', 'Initials': 'X', 'LastName': 'Hua', 'Affiliation': 'National Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Alastair', 'Initials': 'A', 'LastName': 'Gray', 'Affiliation': 'Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Wolstenholme', 'Affiliation': 'Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Clarke', 'Affiliation': 'Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Molyneux', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Richard S C', 'Initials': 'RSC', 'LastName': 'Kerr', 'Affiliation': 'Department of Neurosurgery, John Radcliffe Hospital, Oxford, United Kingdom.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Clarke', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Sneade', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Rivero-Arias', 'Affiliation': 'National Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom.'}]",Neurosurgery,['10.1093/neuros/nyaa454']
1742,33073857,Prolonged antithrombotic therapy in patients after acute coronary syndrome: A critical appraisal of current European Society of Cardiology guidelines.,"The increased risk of non-cardiovascular death in patients receiving clopidogrel or prasugrel in comparison with the placebo group in the dual antiplatelet therapy (DAPT) trial in contrast to the decreased risk of cardiovascular death and all-cause death seen in patients treated with low-dose ticagrelor in the EU label population of the PEGASUS-TIMI 54 trial, resulted in inclusion in the 2020 ESC NSTE-ACS guidelines the recommendation for use of clopidogrel or prasugrel only if the patient is not eligible for treatment with ticagrelor. The prevalence of the primary outcome composed of cardiovascular death, stroke, or myocardial infarction was lower in the low-dose rivaroxaban and acetylsalicylic acid (ASA) group than in the ASA-alone group in the COMPASS trial. Moreover, all-cause mortality and cardiovascular mortality rates were lower in the rivaroxaban-plus-ASA group. Comparison of the PEGASUS-TIMI 54 and COMPASS trial patient characteristics clearly shows that each of these treatment strategies should be addressed at different groups of patients. A greater benefit in post-acute coronary syndrome (ACS) patients with a high risk of ischemic events and without high bleeding risk may be expected with ASA and ticagrelor 60 mg b.i.d. when the therapy is continued without interruption or with short interruption only after ACS. On the other hand, ASA and rivaroxaban 2.5 mg b.i.d. seems to be a better option when indications for dual antithrombotic treatment (DATT) appear after a longer time from ACS (more than two years) and/or from cessation of DAPT (more than one year) and in patients with multiple vascular bed atherosclerosis. Thus, both options of DATTs complement each other rather than compete, as can be presumed from the recommendations. However, a direct comparison between these strategies should be tested in future clinical trials.",2020,"Moreover, all-cause mortality and cardiovascular mortality rates were lower in the rivaroxaban-plus-ASA group.","['patients after acute coronary syndrome', 'patients receiving']","['rivaroxaban', 'rivaroxaban and acetylsalicylic acid (ASA', 'Prolonged antithrombotic therapy', 'rivaroxaban-plus-ASA', 'ASA and ticagrelor', 'placebo', 'ticagrelor', 'clopidogrel or prasugrel']","['mortality and cardiovascular mortality rates', 'risk of cardiovascular death', 'increased risk of non-cardiovascular death', 'cardiovascular death, stroke, or myocardial infarction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}]","[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C1620287', 'cui_str': 'prasugrel'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}]",,0.074908,"Moreover, all-cause mortality and cardiovascular mortality rates were lower in the rivaroxaban-plus-ASA group.","[{'ForeName': 'Jacek', 'Initials': 'J', 'LastName': 'Kubica', 'Affiliation': 'Collegium Medicum, Nicolaus Copernicus University, Ul. Skłodowskiej-Curie 9, 85-094 Bydgoszcz, Poland. jwkubica@gmail.com.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Adamski', 'Affiliation': 'Collegium Medicum, Nicolaus Copernicus University, Ul. Skłodowskiej-Curie 9, 85-094 Bydgoszcz, Poland.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Niezgoda', 'Affiliation': 'Collegium Medicum, Nicolaus Copernicus University, Ul. Skłodowskiej-Curie 9, 85-094 Bydgoszcz, Poland.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Alexopoulos', 'Affiliation': 'National and Kapodistrian University of Athens Medical School, Attikon University Hospital, Athens, Greece.'}, {'ForeName': 'Jolita', 'Initials': 'J', 'LastName': 'Badarienė', 'Affiliation': 'Clinic of Cardiac and Vascular diseases, Institute of Clinical Medicine, Faculty of Medicine, Vilnius University, Vilnius, Lithuania.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Budaj', 'Affiliation': 'Department of Cardiology, Centre of Postgraduate Medical Education, Grochowski Hospital, Warsaw, Poland.'}, {'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Buszko', 'Affiliation': ''}, {'ForeName': 'Dariusz', 'Initials': 'D', 'LastName': 'Dudek', 'Affiliation': 'Institute of Cardiology, Jagiellonian University Medical College, Krakow, Poland.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Fabiszak', 'Affiliation': 'Collegium Medicum, Nicolaus Copernicus University, Ul. Skłodowskiej-Curie 9, 85-094 Bydgoszcz, Poland.'}, {'ForeName': 'Mariusz', 'Initials': 'M', 'LastName': 'Gąsior', 'Affiliation': 'IIIrd Department of Cardiology, Silesian Center for Heart Diseases, Faculty of Medicine in Zabrze, Medical University of Silesia, Zabrze, Poland.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Gil', 'Affiliation': 'Department of Invasive Cardiology, Centre of Postgraduate Medical Education, Central Hospital of the Internal Affairs and Administration Ministry, Warsaw, Poland.'}, {'ForeName': 'Diana A', 'Initials': 'DA', 'LastName': 'Gorog', 'Affiliation': 'Postgraduate Medicine, University of Hertfordshire, United Kingdom and Faculty of Medicine, National Heart and Lung Institute, Imperial College, London, United Kingdom.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Grajek', 'Affiliation': 'Department of Cardiology, Poznan University of Medical Sciences, Poznan, Poland.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Gurbel', 'Affiliation': 'Sinai Center for Thrombosis Research and Drug Development, Sinai Hospital of Baltimore, Baltimore, MD, USA.'}, {'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Gruchała', 'Affiliation': '1st Department of Cardiology, Medical University of Gdańsk, Poland.'}, {'ForeName': 'Miłosz J', 'Initials': 'MJ', 'LastName': 'Jaguszewski', 'Affiliation': '1st Department of Cardiology, Medical University of Gdańsk, Poland.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'James', 'Affiliation': 'Department of Medical Sciences and Uppsala Clinical Research Center, Uppsala University Hospital, Uppsala, Sweden.'}, {'ForeName': 'Young-Hoon', 'Initials': 'YH', 'LastName': 'Jeong', 'Affiliation': 'Department of Internal Medicine, Gyeongsang National University School of Medicine and Cardiovascular Center, Gyeongsang National University Changwon Hospital, Changwon, South Korea.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Jilma', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Austria.'}, {'ForeName': 'Jarosław D', 'Initials': 'JD', 'LastName': 'Kasprzak', 'Affiliation': '1st Department and Chair of Cardiology, Medical University of Lodz Bieganski Hospital, Lodz Poland.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Kleinrok', 'Affiliation': 'University of Information Technology and Management in Rzeszow, Poland.'}, {'ForeName': 'Aldona', 'Initials': 'A', 'LastName': 'Kubica', 'Affiliation': 'Department of Health Promotion, Collegium Medicum, Nicolaus Copernicus University, Bydgoszcz, Poland.'}, {'ForeName': 'Wiktor', 'Initials': 'W', 'LastName': 'Kuliczkowski', 'Affiliation': 'Department of Cardiology, Medical University of Wrocław, Poland.'}, {'ForeName': 'Jacek', 'Initials': 'J', 'LastName': 'Legutko', 'Affiliation': 'Department of Interventional Cardiology, Institute of Cardiology, Jagiellonian University Medical College, John Paul II Hospital in Krakow, Poland.'}, {'ForeName': 'Maciej', 'Initials': 'M', 'LastName': 'Lesiak', 'Affiliation': 'Postgraduate Medicine, University of Hertfordshire, United Kingdom and Faculty of Medicine, National Heart and Lung Institute, Imperial College, London, United Kingdom.'}, {'ForeName': 'Jolanta M', 'Initials': 'JM', 'LastName': 'Siller-Matula', 'Affiliation': 'Department of Experimental and Clinical Pharmacology, Medical University of Warsaw, Poland.'}, {'ForeName': 'Klaudiusz', 'Initials': 'K', 'LastName': 'Nadolny', 'Affiliation': 'Department of Emergency Medical Service, Strategic Planning University of Dabrowa Gornicza, Dabrowa Gornicza, Poland.'}, {'ForeName': 'Krzysztof', 'Initials': 'K', 'LastName': 'Pstrągowski', 'Affiliation': 'Collegium Medicum, Nicolaus Copernicus University, Ul. Skłodowskiej-Curie 9, 85-094 Bydgoszcz, Poland.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Di Somma', 'Affiliation': 'Department of Medical-Surgery Sciences and Translational Medicine, University La Sapienza, Rome, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Specchia', 'Affiliation': 'Pavia, Italy.'}, {'ForeName': 'Janina', 'Initials': 'J', 'LastName': 'Stępińska', 'Affiliation': 'Department of Intensive Cardiac Therapy, National Institute of Cardiology, Warsaw, Poland.'}, {'ForeName': 'Udaya', 'Initials': 'U', 'LastName': 'Tantry', 'Affiliation': 'Sinai Center for Thrombosis Research and Drug Development, Sinai Hospital of Baltimore, Baltimore, MD, USA.'}, {'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Tycińska', 'Affiliation': 'Department of Cardiology, Medical University of Bialystok, Poland.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Verdoia', 'Affiliation': 'Division of Cardiology, Ospedale degli Infermi ASL Biella, Università del Piemonte Orientale, Italy.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Wojakowski', 'Affiliation': 'Division of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland.'}, {'ForeName': 'Eliano P', 'Initials': 'EP', 'LastName': 'Navarese', 'Affiliation': 'Collegium Medicum, Nicolaus Copernicus University, Ul. Skłodowskiej-Curie 9, 85-094 Bydgoszcz, Poland.'}]",Cardiology journal,['10.5603/CJ.a2020.0132']
1743,33073879,"Randomized, Controlled Study of Opicapone in Japanese Parkinson's Patients With Motor Fluctuations.","OBJECTIVES


This placebo-controlled, randomized study evaluated the efficacy and safety of opicapone 25-mg and 50-mg tablets in Japanese levodopa-treated patients with Parkinson's disease and motor fluctuations.
METHODS


Japanese adults (n = 437, age 39-83 years) with Parkinson's disease (United Kingdom Parkinson's Disease Society criteria) received opicapone 25-mg (n = 145), opicapone 50-mg (n = 145), or placebo (n = 147) tablets over the double-blind treatment period (14-15 weeks). The primary efficacy assessment was change in OFF-time; secondary efficacy assessments included OFF/ON-time responders (≥1 hour change from baseline), total ON-time, ON-time with and without troublesome dyskinesia, and Unified Parkinson's Disease Rating Scale.
RESULTS


The least squares mean (standard error) change in OFF-time from baseline to the last visit was -0.42 (0.21) hour for the placebo group, -1.16 (0.22) hour for the opicapone 25 mg group, and -1.04 (0.21) hour for the opicapone 50 mg group. The percentage of ON-time responders, changes in total ON-time/ON-time without troublesome dyskinesia, and Unified Parkinson's Disease Rating Scale II (at OFF) all showed statistically significant improvements versus placebo for both opicapone tablet doses (P < 0.05). Unified Parkinson's Disease Rating Scale III (at ON) was improved versus placebo in patients who received opicapone 50 mg (P < 0.05). Adverse events were more common in patients treated with opicapone 25 mg (60.0%) or opicapone 50 mg (54.5%) versus placebo (48.3%). The most commonly reported adverse event was dyskinesia (placebo, 2.7%; opicapone 25 mg, 9.0%; opicapone 50 mg, 12.4%).
CONCLUSIONS


In Japanese patients, both opicapone 25 and 50 mg were significantly more effective than placebo with no dose-dependent difference in efficacy, and both doses were well tolerated. © 2020 International Parkinson and Movement Disorder Society.",2020,Unified Parkinson's Disease Rating Scale III (at ON) was improved versus placebo in patients who received opicapone 50 mg (P < 0.05).,"[""Japanese adults (n = 437, age 39-83\u2009years) with Parkinson's disease (United Kingdom Parkinson's Disease Society criteria"", ""Japanese Parkinson's Patients With Motor Fluctuations"", ""Japanese levodopa-treated patients with Parkinson's disease and motor fluctuations""]","['opicapone 25-mg and 50-mg tablets', 'opicapone', 'placebo', 'Opicapone', 'opicapone 25-mg (n\u2009=\u2009145), opicapone 50-mg']","[""Unified Parkinson's Disease Rating Scale III (at ON"", 'efficacy and safety', 'Adverse events', ""OFF-time; secondary efficacy assessments included OFF/ON-time responders (≥1\u2009hour change from baseline), total ON-time, ON-time with and without troublesome dyskinesia, and Unified Parkinson's Disease Rating Scale"", ""percentage of ON-time responders, changes in total ON-time/ON-time without troublesome dyskinesia, and Unified Parkinson's Disease Rating Scale II"", 'tolerated', 'least squares mean (standard error) change in OFF-time']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1868976', 'cui_str': 'Motor fluctuations'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C2933912', 'cui_str': 'opicapone'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4517577', 'cui_str': '145'}]","[{'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0013384', 'cui_str': 'Dyskinesia'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0023189', 'cui_str': 'Analysis, Least-Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0038137', 'cui_str': 'standards'}]",,0.128247,Unified Parkinson's Disease Rating Scale III (at ON) was improved versus placebo in patients who received opicapone 50 mg (P < 0.05).,"[{'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Takeda', 'Affiliation': 'National Hospital Organization, Sendai-Nishitaga Hospital, Sendai, Japan.'}, {'ForeName': 'Ryosuke', 'Initials': 'R', 'LastName': 'Takahashi', 'Affiliation': 'Department of Neurology, Kyoto University Graduate School of Medicine, Kyoto, Japan.'}, {'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Tsuboi', 'Affiliation': 'Department of Neurology, Fukuoka University Hospital, Fukuoka, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Nomoto', 'Affiliation': 'Department of Neurology and Clinical Pharmacology, Ehime University Graduate School of Medicine, Toon, Japan.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Maeda', 'Affiliation': 'Division of Neurology and Gerontology, Department of Internal Medicine, School of Medicine, Iwate Medical University, Shiwa, Japan.'}, {'ForeName': 'Akihisa', 'Initials': 'A', 'LastName': 'Nishimura', 'Affiliation': 'Department of Clinical Development, Ono Pharmaceutical Co., Ltd., Osaka, Japan.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Yoshida', 'Affiliation': 'Department of Clinical Development, Ono Pharmaceutical Co., Ltd., Osaka, Japan.'}, {'ForeName': 'Nobutaka', 'Initials': 'N', 'LastName': 'Hattori', 'Affiliation': 'Department of Neurology, Juntendo University Graduate School of Medicine, Tokyo, Japan.'}]",Movement disorders : official journal of the Movement Disorder Society,['10.1002/mds.28322']
1744,33073933,Evaluation of Improvement in Skin and Nail Psoriasis in Bio-naïve Patients With Active Psoriatic Arthritis Treated With Golimumab: Results Through Week 52 of the GO-VIBRANT Study.,"OBJECTIVE


To evaluate whether intravenous (IV) golimumab produces improvements in skin and nail symptoms that are concomitant with improvements in quality of life (QoL) and joint symptoms in patients with psoriatic arthritis.
METHODS


Patients were randomized to either IV golimumab 2 mg/kg at weeks 0, 4, then every 8 weeks (q8w) through week 52 or placebo at weeks 0, 4, then q8w, with crossover to IV golimumab 2 mg/kg at weeks 24, 28, and then q8w through week 52. Assessments included Psoriasis Area and Severity Index (PASI), modified Nail Psoriasis Severity Index (mNAPSI), Dermatology Life Quality Index (DLQI), and American College of Rheumatology (ACR) rheumatoid arthritis response criteria.
RESULTS


Through week 24, achievement of PASI 75/90/100 responses (P ≤ .0098) and mean improvements in mNAPSI (-11.4 vs -3.7; P < .0001) and DLQI (-9.8 vs -2.9; P < .0001) were significantly greater with golimumab versus placebo. Responses were maintained in patients treated with golimumab through week 52. In placebo-crossover patients, increases in the proportion of patients achieving PASI 75/90/100 responses were observed from weeks 24 to 52, and mean improvements in mNAPSI (from -3.7 to -12.9) and DLQI (from -2.9 to -7.8) increased from weeks 24 to 52. Simultaneous achievement of PASI and DLQI responses, PASI and ACR responses, and mNAPSI and DLQI responses were also observed. Similar responses were observed for all assessments regardless of concomitant methotrexate use.
CONCLUSION


Improvements in skin and nail psoriasis symptoms with IV golimumab in patients with psoriatic arthritis were concomitant with improvements in QoL and arthritis disease activity through 1 year.",2020,"Through week 24, achievement of PASI 75/90/100 responses (P ≤ .0098) and mean improvements in mNAPSI (-11.4 vs -3.7; P < .0001) and DLQI (-9.8 vs -2.9; P < .0001) were significantly greater with golimumab versus placebo.","['Patients', 'patients with psoriatic arthritis']","['Golimumab', 'placebo', 'IV golimumab', 'intravenous (IV) golimumab']","['mean improvements in mNAPSI', 'mNAPSI', 'proportion of patients achieving PASI 75/90/100 responses', 'QoL and arthritis disease activity', 'Psoriasis Area and Severity Index (PASI), modified Nail Psoriasis Severity Index (mNAPSI), Dermatology Life Quality Index (DLQI), and American College of Rheumatology (ACR) rheumatoid arthritis response criteria', 'Skin and Nail Psoriasis', 'quality of life (QoL) and joint symptoms', 'PASI and DLQI responses, PASI and ACR responses, and mNAPSI and DLQI responses', 'DLQI', 'skin and nail symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic arthritis'}]","[{'cui': 'C2353893', 'cui_str': 'golimumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0406322', 'cui_str': 'Psoriasis of nail'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0003864', 'cui_str': 'Arthritis'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0451112', 'cui_str': 'Dermatology life quality index'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0027342', 'cui_str': 'Nail plate structure'}]",,0.081377,"Through week 24, achievement of PASI 75/90/100 responses (P ≤ .0098) and mean improvements in mNAPSI (-11.4 vs -3.7; P < .0001) and DLQI (-9.8 vs -2.9; P < .0001) were significantly greater with golimumab versus placebo.","[{'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Mease', 'Affiliation': 'Swedish Medical Center, Seattle, Washington and University of Washington School of Medicine, Seattle.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Elaine Husni', 'Affiliation': 'Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Soumya D', 'Initials': 'SD', 'LastName': 'Chakravarty', 'Affiliation': 'Janssen Scientific Affairs, LLC, Horsham, Pennsylvania, and, Drexel University College of Medicine, Philadelphia, PA.'}, {'ForeName': 'Shelly', 'Initials': 'S', 'LastName': 'Kafka', 'Affiliation': 'Janssen Scientific Affairs, LLC, Horsham, Pennsylvania.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Parenti', 'Affiliation': 'Janssen Scientific Affairs, LLC, Horsham, Pennsylvania.'}, {'ForeName': 'Lilianne', 'Initials': 'L', 'LastName': 'Kim', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, Pennsylvania.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Hung Lo', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, Pennsylvania.'}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Hsia', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, Pennsylvania, and University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'Kavanaugh', 'Affiliation': 'University of California, San Diego.'}]",ACR open rheumatology,['10.1002/acr2.11180']
1745,33073938,"Effect of Pentoxifylline on Inflammatory Cytokines, Adequacy of Dialysis, Anemia and Biochemical Markers of Hemodialysis Patients: a Randomized Controlled Trial.","BACKGROUND


The main cause of death in hemodialysis patients is cardiovascular disease (CVD). Chronic inflammation is strongly related with CVD, atherosclerosis, and malnutrition in end-stage renal disease (ESRD) patients. We aimed to investigate the effect of pentoxifylline on adequacy of dialysis, anemia, inflammatory cytokines, and biochemical markers in patients with ESRD on hemodialysis.
METHODS


This was a randomized controlled trial with a negative result conducted on 42 hemodialysis patients. The patients were randomly divided to two groups; intervention group (400 mg pentoxifylline every night for three months) and control group (followed up without taking pentoxifylline). The blood samples were taken to measure the levels of inflammatory cytokines, anemia-related parameters, and biochemical markers at baseline and the end of treatment.
RESULTS


Thirty-six patients finished the study (18 patients in each group). There was significant reduction in C-reactive protein (CRP) [9.25 (4.60, 17.62) vs. 5.60 (1.90, 11.52), p = 0.048] and TNF-α [28.06 (19.76, 61.22) vs. 18.06 (14.39, 28.97), p = 0.029], and significant increase of albumin levels (4.05 ± 0.25 vs. 4.35 ± 0.24, p = 0.000) in the intervention group, but these changes were not significant in comparison with the control group. No statistically significant difference was observed between intervention and control groups in other parameters.
CONCLUSIONS


Although pentoxifylline administration had caused significant reduction in CRP and TNF-α, as well as significant increase of albumin levels in the intervention group, but these changes were not significant in comparison with control group. The current study does not support the use of pentoxifylline in hemodialysis patients.",2020,"There was significant reduction in C-reactive protein (CRP) [9.25 (4.60, 17.62) vs. 5.60 (1.90, 11.52), p = 0.048] and TNF-α [28.06 (19.76, 61.22) vs. 18.06 (14.39, 28.97), p = 0.029], and significant increase of albumin levels (4.05 ± 0.25 vs. 4.35 ± 0.24, p = 0.000) in the intervention group, but these changes were not significant in comparison with the control group.","['patients with ESRD on hemodialysis', 'hemodialysis patients', '42 hemodialysis patients', 'Hemodialysis Patients', 'hemodialysis patients is cardiovascular disease (CVD']","['Pentoxifylline', 'pentoxifylline', 'intervention group (400 mg pentoxifylline every night for three months) and control group (followed up without taking pentoxifylline']","['levels of inflammatory cytokines, anemia-related parameters, and biochemical markers', 'albumin levels', 'CRP and TNF-α', 'adequacy of dialysis, anemia, inflammatory cytokines, and biochemical markers', 'Chronic inflammation', 'Inflammatory Cytokines, Adequacy of Dialysis, Anemia and Biochemical Markers', 'TNF-α', 'C-reactive protein (CRP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}]","[{'cui': 'C0030899', 'cui_str': 'Pentoxifylline'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C4082119', 'cui_str': 'Three months'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C1515187', 'cui_str': 'Take'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0206015', 'cui_str': 'Biochemical Markers'}, {'cui': 'C0201838', 'cui_str': 'Albumin measurement'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0429660', 'cui_str': 'Adequacy of dialysis'}, {'cui': 'C0021376', 'cui_str': 'Chronic inflammation'}]",42.0,0.0476202,"There was significant reduction in C-reactive protein (CRP) [9.25 (4.60, 17.62) vs. 5.60 (1.90, 11.52), p = 0.048] and TNF-α [28.06 (19.76, 61.22) vs. 18.06 (14.39, 28.97), p = 0.029], and significant increase of albumin levels (4.05 ± 0.25 vs. 4.35 ± 0.24, p = 0.000) in the intervention group, but these changes were not significant in comparison with the control group.","[{'ForeName': 'Moslem', 'Initials': 'M', 'LastName': 'Sedaghattalab', 'Affiliation': ''}, {'ForeName': 'Valiollah', 'Initials': 'V', 'LastName': 'Talebi', 'Affiliation': ''}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Manzouri', 'Affiliation': ''}, {'ForeName': 'Rozina A', 'Initials': 'RA', 'LastName': 'Larki', 'Affiliation': ''}, {'ForeName': 'Amir H', 'Initials': 'AH', 'LastName': 'Doustimotlagh', 'Affiliation': ''}]",Clinical laboratory,['10.7754/Clin.Lab.2020.191257']
1746,33074237,Benfotiamine and Cognitive Decline in Alzheimer's Disease: Results of a Randomized Placebo-Controlled Phase IIa Clinical Trial.,"BACKGROUND


In preclinical models, benfotiamine efficiently ameliorates the clinical and biological pathologies that define Alzheimer's disease (AD) including impaired cognition, amyloid-β plaques, neurofibrillary tangles, diminished glucose metabolism, oxidative stress, increased advanced glycation end products (AGE), and inflammation.
OBJECTIVE


To collect preliminary data on feasibility, safety, and efficacy in individuals with amnestic mild cognitive impairment (aMCI) or mild dementia due to AD in a placebo-controlled trial of benfotiamine.
METHODS


A twelve-month treatment with benfotiamine tested whether clinical decline would be delayed in the benfotiamine group compared to the placebo group. The primary clinical outcome was the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog). Secondary outcomes were the clinical dementia rating (CDR) score and fluorodeoxyglucose (FDG) uptake, measured with brain positron emission tomography (PET). Blood AGE were examined as an exploratory outcome.
RESULTS


Participants were treated with benfotiamine (34) or placebo (36). Benfotiamine treatment was safe. The increase in ADAS-Cog was 43% lower in the benfotiamine group than in the placebo group, indicating less cognitive decline, and this effect was nearly statistically significant (p = 0.125). Worsening in CDR was 77% lower (p = 0.034) in the benfotiamine group compared to the placebo group, and this effect was stronger in the APOEɛ4 non-carriers. Benfotiamine significantly reduced increases in AGE (p = 0.044), and this effect was stronger in the APOEɛ4 non-carriers. Exploratory analysis derivation of an FDG PET pattern score showed a treatment effect at one year (p = 0.002).
CONCLUSION


Oral benfotiamine is safe and potentially efficacious in improving cognitive outcomes among persons with MCI and mild AD.",2020,"The increase in ADAS-Cog was 43% lower in the benfotiamine group than in the placebo group, indicating less cognitive decline, and this effect was nearly statistically significant (p = 0.125).","[""Alzheimer's Disease"", 'persons with MCI and mild AD', 'individuals with amnestic mild cognitive impairment (aMCI) or mild dementia due to AD in a placebo-controlled trial of benfotiamine', 'Participants were treated with benfotiamine (34) or']","['Oral benfotiamine', 'benfotiamine', 'placebo', 'Benfotiamine', 'Placebo']","['Worsening in CDR', ""Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog"", 'AGE', 'FDG PET pattern score', 'cognitive outcomes', 'clinical dementia rating (CDR) score and fluorodeoxyglucose (FDG) uptake, measured with brain positron emission tomography (PET', 'Blood AGE', 'ADAS-Cog', 'feasibility, safety, and efficacy']","[{'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0560005', 'cui_str': 'mCi'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C3494623', 'cui_str': 'Mild dementia'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0053116', 'cui_str': 'benphothiamine'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0053116', 'cui_str': 'benphothiamine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0451074', 'cui_str': 'Clinical dementia rating scale'}, {'cui': 'C0450989', 'cui_str': ""Alzheimer's Disease Assessment Scale""}, {'cui': 'C0162574', 'cui_str': 'Advanced Glycation End Products'}, {'cui': 'C3641247', 'cui_str': 'FDG PET scan'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0046056', 'cui_str': 'Fluorodeoxyglucose F18'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0032743', 'cui_str': 'Positron emission tomography'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.417553,"The increase in ADAS-Cog was 43% lower in the benfotiamine group than in the placebo group, indicating less cognitive decline, and this effect was nearly statistically significant (p = 0.125).","[{'ForeName': 'Gary E', 'Initials': 'GE', 'LastName': 'Gibson', 'Affiliation': 'Brain and Mind Research Institute, Weil Cornell Medicine, New York, NY, USA.'}, {'ForeName': 'José A', 'Initials': 'JA', 'LastName': 'Luchsinger', 'Affiliation': 'Departments of Medicine and Epidemiology, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Rosanna', 'Initials': 'R', 'LastName': 'Cirio', 'Affiliation': 'Burke Neurological Institute, White Plains, NY, USA.'}, {'ForeName': 'Huanlian', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Burke Neurological Institute, White Plains, NY, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Franchino-Elder', 'Affiliation': 'Burke Neurological Institute, White Plains, NY, USA.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Hirsch', 'Affiliation': 'Burke Neurological Institute, White Plains, NY, USA.'}, {'ForeName': 'Lucien', 'Initials': 'L', 'LastName': 'Bettendorff', 'Affiliation': 'Laboratory of Neurophysiology, GIGA-Neurosciences, University of Liege, Belgium.'}, {'ForeName': 'Zhengming', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Healthcare Policy and Research, Weill Cornell Medicine, New York, NY, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Flowers', 'Affiliation': 'Department of Neuroscience, Georgetown University, Washington, DC, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Gerber', 'Affiliation': 'Department of Public Health, Weill Cornell Medicine, New York, NY, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Grandville', 'Affiliation': 'Burke Rehabilitation Hospital, White Plains, NY, USA.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Schupf', 'Affiliation': ""Mailman School of Public Health, The Taub Institute for Research on Alzheimer's Disease and the Aging Brain, Columbia University Irvine Medical Center, New York, NY, USA.""}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Burke Neurological Institute, White Plains, NY, USA.'}, {'ForeName': 'Yaakov', 'Initials': 'Y', 'LastName': 'Stern', 'Affiliation': ""Departments of Neurology, Psychiatry, and Psychology, and the Taub Institute for the Research on Alzheimer's Disease and the Aging Brain, Columbia University Irvine Medical Center, New York, NY, USA.""}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Habeck', 'Affiliation': ""Department of Neurology and the Taub Institute for Research on Alzheimer's Disease and the Aging Brain, Columbia University Irvine Medical Center, New York, NY, USA.""}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Jordan', 'Affiliation': 'Rancho Los Amigos National Rehabilitation Center, Downey, CA, USA.'}, {'ForeName': 'Pasquale', 'Initials': 'P', 'LastName': 'Fonzetti', 'Affiliation': 'Einstein College of Medicine, Westmed Medical Group, Bronx, NY, USA.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-200896']
1747,33074282,Short-term Outcomes of the Study of Refeeding to Optimize Inpatient Gains for Patients With Anorexia Nervosa: A Multicenter Randomized Clinical Trial.,"Importance


The standard of care for refeeding inpatients with anorexia nervosa, starting with low calories and advancing cautiously, is associated with slow weight gain and protracted hospital stay. Limited data suggest that higher-calorie refeeding improves these outcomes with no increased risk of refeeding syndrome.
Objective


To compare the short-term efficacy, safety, and cost of lower-calorie vs higher-calorie refeeding for malnourished adolescents and young adults with anorexia nervosa.
Design, Setting, and Participants


In this multicenter randomized clinical trial with prospective follow-up conducted at 2 inpatient eating disorder programs at large tertiary care hospitals, 120 adolescents and young adults aged 12 to 24 years hospitalized with anorexia nervosa or atypical anorexia nervosa and 60% or more of median body mass index were enrolled from February 8, 2016, to March 7, 2019. The primary analysis was a modified intent-to-treat approach.
Interventions


Higher-calorie refeeding, beginning at 2000 kcal/d and increasing by 200 kcal/d vs lower-calorie refeeding, beginning at 1400 k/cal and increasing by 200 kcal every other day.
Main Outcomes and Measures


Main outcomes were end-of-treatment outcomes; the primary end point of this trial will be clinical remission over 12 months. Short-term efficacy was defined a priori as time to restore medical stability in the hospital, measured by the following 6 indices: 24-hour heart rate of 45 beats/min or more, systolic blood pressure of 90 mm Hg or more, temperature of 35.6 °C or more, orthostatic increase in heart rate of 35 beats/min or less, orthostatic decrease in systolic blood pressure of 20 mm Hg or less, and 75% or more of median body mass index for age and sex. The prespecified safety outcome was incidence of electrolyte abnormalities; cost efficacy was defined as savings associated with length of stay.
Results


Because 9 participants withdrew prior to treatment, the modified intention-to-treat analyses included 111 participants (93%; 101 females [91%]; mean [SD] age, 16.4 [2.5] years). Higher-calorie refeeding restored medical stability significantly earlier than lower-calorie refeeding (hazard ratio, 1.67 [95% CI, 1.10-2.53]; P = .01). Electrolyte abnormalities and other adverse events did not differ by group. Hospital stay was 4.0 days shorter (95% CI, -6.1 to -1.9 days) among the group receiving higher-calorie refeeding, which was associated with a savings of $19 056 (95% CI, -$28 819 to -$9293) in hospital charges per participant.
Conclusions and Relevance


In the first randomized clinical trial in the US to compare refeeding approaches in patients with anorexia nervosa and atypical anorexia nervosa, higher-calorie refeeding demonstrated short-term efficacy with no increase in safety events during hospitalization.
Trial Registration


ClinicalTrials.gov Identifier: NCT02488109.",2020,"Hospital stay was 4.0 days shorter (95% CI, -6.1 to -1.9 days) among the group receiving higher-calorie refeeding, which was associated with a savings of $19 056 (95% CI, -$28 819 to -$9293) in hospital charges per participant.
","['refeeding inpatients with anorexia nervosa', 'malnourished adolescents and young adults with anorexia nervosa', 'participants withdrew prior to treatment, the modified intention-to-treat analyses included 111 participants (93%; 101 females [91%]; mean [SD] age, 16.4 [2.5] years', 'Patients With Anorexia Nervosa', 'patients with anorexia nervosa and atypical anorexia nervosa', '2 inpatient eating disorder programs at large tertiary care hospitals, 120 adolescents and young adults aged 12 to 24 years hospitalized with anorexia nervosa or atypical anorexia nervosa and 60% or more of median body mass index were enrolled from February 8, 2016, to March 7, 2019']",['lower-calorie vs higher-calorie refeeding'],"['incidence of electrolyte abnormalities; cost efficacy', 'savings associated with length of stay', 'orthostatic increase in heart rate', 'clinical remission', '24-hour heart rate of 45 beats/min or more, systolic blood pressure', 'risk of refeeding syndrome', 'safety events', 'orthostatic decrease in systolic blood pressure', 'Hospital stay', 'Electrolyte abnormalities and other adverse events']","[{'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0003125', 'cui_str': 'Anorexia nervosa'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0338959', 'cui_str': 'Atypical anorexia nervosa'}, {'cui': 'C0013473', 'cui_str': 'Eating disorder'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0151613', 'cui_str': 'Electrolytes abnormal'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036245', 'cui_str': 'Savings'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0039231', 'cui_str': 'Tachycardia'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0860549', 'cui_str': 'Refeeding syndrome'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.187957,"Hospital stay was 4.0 days shorter (95% CI, -6.1 to -1.9 days) among the group receiving higher-calorie refeeding, which was associated with a savings of $19 056 (95% CI, -$28 819 to -$9293) in hospital charges per participant.
","[{'ForeName': 'Andrea K', 'Initials': 'AK', 'LastName': 'Garber', 'Affiliation': 'Division of Adolescent and Young Adult Medicine, Department of Pediatrics, University of California, San Francisco.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Cheng', 'Affiliation': 'Department of Preventive and Restorative Dental Sciences, University of California, San Francisco.'}, {'ForeName': 'Erin C', 'Initials': 'EC', 'LastName': 'Accurso', 'Affiliation': 'Department of Psychiatry and Behavioral Medicine, University of California, San Francisco.'}, {'ForeName': 'Sally H', 'Initials': 'SH', 'LastName': 'Adams', 'Affiliation': 'Division of Adolescent and Young Adult Medicine, Department of Pediatrics, University of California, San Francisco.'}, {'ForeName': 'Sara M', 'Initials': 'SM', 'LastName': 'Buckelew', 'Affiliation': 'Division of Adolescent and Young Adult Medicine, Department of Pediatrics, University of California, San Francisco.'}, {'ForeName': 'Cynthia J', 'Initials': 'CJ', 'LastName': 'Kapphahn', 'Affiliation': 'Division of Adolescent Medicine, Department of Pediatrics, Stanford University, Stanford, California.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Kreiter', 'Affiliation': 'Division of Adolescent Medicine, Department of Pediatrics, Stanford University, Stanford, California.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Le Grange', 'Affiliation': 'Division of Adolescent and Young Adult Medicine, Department of Pediatrics, University of California, San Francisco.'}, {'ForeName': 'Vanessa I', 'Initials': 'VI', 'LastName': 'Machen', 'Affiliation': 'Division of Adolescent and Young Adult Medicine, Department of Pediatrics, University of California, San Francisco.'}, {'ForeName': 'Anna-Barbara', 'Initials': 'AB', 'LastName': 'Moscicki', 'Affiliation': 'Division of Adolescent and Young Adult Medicine, Department of Pediatrics, University of California, Los Angeles.'}, {'ForeName': 'Allyson', 'Initials': 'A', 'LastName': 'Sy', 'Affiliation': 'Division of Adolescent Medicine, Department of Pediatrics, Stanford University, Stanford, California.'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Wilson', 'Affiliation': 'Department of Clinical Pharmacy, University of California, San Francisco.'}, {'ForeName': 'Neville H', 'Initials': 'NH', 'LastName': 'Golden', 'Affiliation': 'Division of Adolescent Medicine, Department of Pediatrics, Stanford University, Stanford, California.'}]",JAMA pediatrics,['10.1001/jamapediatrics.2020.3359']
1748,33074283,Association of Medicaid-Focused or Commercial Medicaid Managed Care Plan Type With Outpatient and Acute Care.,"Importance


Enrollment in Medicaid managed care plans has increased rapidly, particularly in national commercial insurance plans. Whether the type of managed care plan is associated with the use of health services for Medicaid beneficiaries is unknown.
Objective


To compare the use of outpatient and acute care between Medicaid enrollees randomly assigned to a national commercial managed care plan or a local Medicaid-focused managed care plan.
Design, Setting, and Participants


This natural experiment of a cohort of Medicaid enrollees randomly assigned to 2 managed care plans in a Northeastern US state was conducted from June 30, 2009, to June 30, 2013. Statistical analysis was performed from September 1, 2019, to August 30, 2020.
Interventions


Assignment to a Medicaid-focused insurance plan or a commercial managed care plan.
Main Outcomes and Measures


Outpatient visits, emergency department visits, and total inpatient and ambulatory care-sensitive hospitalizations.
Results


A total of 8010 patients were included in the analysis: 4737 were assigned to a Medicaid-focused plan (2795 female [59.0%]; mean [SD] age, 17.8 [3.2] years) and 3273 to a commercial managed care plan (1915 female [58.5%]; mean [SD] age, 17.9 [3.3] years). Those randomly assigned to the Medicaid-focused plan had a mean (SD) of 6.67 (9.18) annual outpatient visits per person, and those assigned to the commercial plan had a mean (SD) of 8.36 (11.77) annual outpatient visits per person (adjusted absolute difference, 1.72 [95% CI, 1.31-2.13]; 22% relative difference). The increased use of outpatient visits in the commercial plan was associated with an increase in specialty care visits (mean [SD], 2.34 [6.31] visits in Medicaid-focused plan vs 3.75 [9.32] visits in commerical plan; adjusted absolute difference, 1.43 visits [95% CI, 1.25-1.56 visits]; 61% relative difference). Mean (SD) annual emergency department visits were 0.49 (1.39) per person in the Medicaid-focused plan and 0.51 (1.40) in the commercial plan (adjusted absolute difference, 0.02 [95% CI, -0.02 to 0.05]). Mean (SD) annual inpatient admissions were 0.067 (0.45) per person in the Medicaid-focused plan and 0.069 (0.53) in the commercial plan (adjusted absolute difference, 0.003 [95% CI, -0.01 to 0.02]). Plan assignment was not significantly associated with ambulatory care-sensitive admissions. Results were consistent in instrumental variables analyses that accounted for disenrollment and switching.
Conclusions and Relevance


Compared with Medicaid managed care enrollees assigned to a Medicaid-focused plan, those assigned to a commercial plan had more outpatient visits, particularly for specialty care, but had similar rates of emergency department visits and hospitalizations. These findings suggest that the type of managed care plan may be associated with health services use and spending among Medicaid beneficiaries and that random assignment may help states understand how well different plans perform for enrollees.",2020,"The increased use of outpatient visits in the commercial plan was associated with an increase in specialty care visits (mean [SD], 2.34","['mean [SD] age, 17.8 [3.2] years) and 3273 to a commercial managed care plan (1915 female [58.5%]; mean [SD] age, 17.9 [3.3] years', 'A total of 8010 patients were included in the analysis: 4737 were assigned to a Medicaid-focused plan (2795 female [59.0', 'cohort of Medicaid enrollees randomly assigned to 2 managed care plans in a Northeastern US state was conducted from June 30, 2009, to June 30, 2013']","['national commercial managed care plan or a local Medicaid-focused managed care plan', 'Medicaid-focused insurance plan or a commercial managed care plan']","['Mean (SD) annual inpatient admissions', 'specialty care visits', 'Mean (SD) annual emergency department visits', 'Measures\n\n\nOutpatient visits, emergency department visits, and total inpatient and ambulatory care-sensitive hospitalizations']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517687', 'cui_str': '3.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086583', 'cui_str': 'Managed Care'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517688', 'cui_str': '3.3'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0025071', 'cui_str': 'Medicaid coverage'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}]","[{'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0086583', 'cui_str': 'Managed Care'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0025071', 'cui_str': 'Medicaid coverage'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0021672', 'cui_str': 'Insurance'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0037778', 'cui_str': 'Medical specialty'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0002423', 'cui_str': 'Outpatient Care'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",8010.0,0.0869955,"The increased use of outpatient visits in the commercial plan was associated with an increase in specialty care visits (mean [SD], 2.34","[{'ForeName': 'Shailender', 'Initials': 'S', 'LastName': 'Swaminathan', 'Affiliation': 'Leveraging Evidence for Access and Development, Krea University, Sricity, India.'}, {'ForeName': 'Chima D', 'Initials': 'CD', 'LastName': 'Ndumele', 'Affiliation': 'Department of Health Policy and Management, Yale School of Public Health, New Haven, Connecticut.'}, {'ForeName': 'Sarah H', 'Initials': 'SH', 'LastName': 'Gordon', 'Affiliation': 'Department of Health Law, Policy, and Management, Boston University School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Yoojin', 'Initials': 'Y', 'LastName': 'Lee', 'Affiliation': 'Department of Health Services, Policy and Practice, Brown University, Providence, Rhode Island.'}, {'ForeName': 'Amal N', 'Initials': 'AN', 'LastName': 'Trivedi', 'Affiliation': 'Department of Health Services, Policy and Practice, Brown University, Providence, Rhode Island.'}]",JAMA internal medicine,['10.1001/jamainternmed.2020.5408']
1749,33074284,Microbleeds and the Effect of Anticoagulation in Patients With Embolic Stroke of Undetermined Source: An Exploratory Analysis of the NAVIGATE ESUS Randomized Clinical Trial.,"Importance


The reported associations of cerebral microbleeds with recurrent stroke and intracerebral hemorrhage have raised concerns regarding antithrombotic treatment in patients with a history of stroke and microbleeds on magnetic resonance imaging.
Objective


To characterize microbleeds in embolic strokes of undetermined source (ESUS) and report interactions between microbleeds and the effects of random assignment to anticoagulant vs antiplatelet therapy.
Design, Setting, and Participants


Subgroup analyses of the New Approach Rivaroxaban Inhibition of Factor Xa in a Global Trial vs Aspirin to Prevent Embolism in ESUS (NAVIGATE ESUS) international, double-blind, randomized, event-driven phase 3 clinical trial. Participants were enrolled between December 2014 and September 2017 and followed up for a median of 11 months. The study setting included 459 stroke recruitment centers in 31 countries. Patients aged 50 years or older who had neuroimaging-confirmed ESUS between 7 days and 6 months before screening were eligible. Of these 7213 NAVIGATE ESUS participants, 3699 (51%) had information on cerebral microbleeds reported on their baseline clinical magnetic resonance imaging and were eligible for these analyses. Patients with a prior history of symptomatic intracerebral hemorrhage were excluded from the NAVIGATE ESUS trial.
Interventions


Rivaroxaban, 15 mg, compared with aspirin, 100 mg, daily.
Main Outcomes and Measures


The primary outcome was recurrent stroke. Secondary outcomes were ischemic stroke, intracerebral hemorrhage, and all-cause mortality.
Results


Microbleeds were present in 395 of 3699 participants (11%). Of patients with cerebral microbleeds, mean (SD) age was 69.5 (9.4) years, 241 were men (61%), and 201 were White (51%). Advancing age (odds ratio [OR] per year, 1.03; 95% CI, 1.01-1.04), East Asian race/ethnicity (OR, 1.57; 95% CI, 1.04-2.37), hypertension (OR, 2.20; 95% CI, 1.54-3.15), multiterritorial infarcts (OR, 1.95; 95% CI, 1.42-2.67), chronic infarcts (OR, 1.78; 95% CI, 1.42-2.23), and occult intracerebral hemorrhage (OR, 5.23; 95% CI, 2.76-9.90) were independently associated with microbleeds. The presence of microbleeds was associated with a 1.5-fold increased risk of recurrent stroke (hazard ratio [HR], 1.5; 95% CI, 1.0-2.3), a 4-fold risk of intracerebral hemorrhage (HR, 4.2; 95% CI, 1.3-13.9), a 2-fold risk of all-cause mortality (HR, 2.1; 95% CI, 1.1-4.3), and strictly lobar microbleeds with an approximately 2.5-fold risk of ischemic stroke (HR, 2.3; 95% CI, 1.3-4.3). There were no interactions between microbleeds and treatment assignments for recurrent stroke, ischemic stroke, or all-cause mortality. The HR of intracerebral hemorrhage on rivaroxaban was similar between persons with microbleeds (HR, 3.1; 95% CI, 0.3-30.0) and persons without microbleeds (HR, 3.0; 95% CI, 0.6-14.7; interaction P > .99).
Conclusions and Relevance


Microbleeds mark an increased risk of recurrent stroke, ischemic stroke, intracerebral hemorrhage, and mortality in ESUS but do not appear to influence effects of rivaroxaban on clinical outcomes.
Trial Registration


ClinicalTrials.gov Identifier: NCT02313909.",2020,"There were no interactions between microbleeds and treatment assignments for recurrent stroke, ischemic stroke, or all-cause mortality.","['Participants were enrolled between December 2014 and September 2017 and followed up for a median of 11 months', 'Patients With Embolic Stroke of Undetermined Source', 'Patients aged 50 years or older who had neuroimaging-confirmed ESUS between 7 days and 6 months before screening were eligible', '459 stroke recruitment centers in 31 countries', 'Of patients with cerebral microbleeds, mean (SD) age was 69.5 (9.4) years, 241 were men (61%), and 201 were White (51', 'Patients with a prior history of symptomatic intracerebral hemorrhage', 'patients with a history of stroke and microbleeds on magnetic resonance imaging']","['Aspirin', 'rivaroxaban', 'Rivaroxaban', 'aspirin']","['chronic infarcts', 'occult intracerebral hemorrhage', '4-fold risk of intracerebral hemorrhage', 'recurrent stroke, ischemic stroke, or all-cause mortality', 'ischemic stroke', 'multiterritorial infarcts', 'risk of recurrent stroke', 'ischemic stroke, intracerebral hemorrhage, and all-cause mortality', 'hypertension', 'recurrent stroke', 'HR of intracerebral hemorrhage']","[{'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3888970', 'cui_str': 'Embolic stroke of undetermined source'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}]","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0028794', 'cui_str': 'Occultism'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0185026', 'cui_str': 'Plication'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1836785', 'cui_str': 'Recurrent stroke'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]",,0.476199,"There were no interactions between microbleeds and treatment assignments for recurrent stroke, ischemic stroke, or all-cause mortality.","[{'ForeName': 'Ashkan', 'Initials': 'A', 'LastName': 'Shoamanesh', 'Affiliation': 'Division of Neurology, McMaster University / Population Health Research Institute, Hamilton, Ontario, Canada.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Hart', 'Affiliation': 'Division of Neurology, McMaster University / Population Health Research Institute, Hamilton, Ontario, Canada.'}, {'ForeName': 'Stuart J', 'Initials': 'SJ', 'LastName': 'Connolly', 'Affiliation': 'Division of Neurology, McMaster University / Population Health Research Institute, Hamilton, Ontario, Canada.'}, {'ForeName': 'Scott E', 'Initials': 'SE', 'LastName': 'Kasner', 'Affiliation': 'Department of Neurology, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Eric E', 'Initials': 'EE', 'LastName': 'Smith', 'Affiliation': 'Department of Clinical Neurosciences, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Martí-Fàbregas', 'Affiliation': 'Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.'}, {'ForeName': 'Yan Yun', 'Initials': 'YY', 'LastName': 'Liu', 'Affiliation': 'Department of Statistics, Population Health Research Institute, Hamilton, Ontario, Canada.'}, {'ForeName': 'Shinichiro', 'Initials': 'S', 'LastName': 'Uchiyama', 'Affiliation': 'Department of Neurology, Clinical Research Center for Medicine, International University of Health and Welfare, Tokyo, Japan.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Mikulik', 'Affiliation': ""International Clinical Research Center and Department of Neurology, St. Anne's University Hospital and Masaryk University, Brno, Czech Republic.""}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Veltkamp', 'Affiliation': 'Department of Neurology, Imperial College Healthcare NHS Trust, London, United Kingdom.'}, {'ForeName': 'Martin J', 'Initials': 'MJ', 'LastName': ""O'Donnell"", 'Affiliation': 'Division of Neurology, McMaster University / Population Health Research Institute, Hamilton, Ontario, Canada.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Ntaios', 'Affiliation': 'Department of Internal Medicine, University of Thessaly, Larissa, Greece.'}, {'ForeName': 'Keith W', 'Initials': 'KW', 'LastName': 'Muir', 'Affiliation': 'Institute of Neuroscience & Psychology, University of Glasgow, Glasgow, Scotland.'}, {'ForeName': 'Thalia S', 'Initials': 'TS', 'LastName': 'Field', 'Affiliation': 'Division of Neurology, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Gustavo C', 'Initials': 'GC', 'LastName': 'Santo', 'Affiliation': 'Department of Neurology, Hospitais da Universidade de Coimbra, Coimbra, Portugal.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Olavarria', 'Affiliation': 'Department of Neurology and Psychiatry, Clínica Alemana de Santiago, Facultad de Medicina, Clínica Alemana Universidad del Desarrollo, Santiago, Chile.'}, {'ForeName': 'Hardi', 'Initials': 'H', 'LastName': 'Mundl', 'Affiliation': 'Pharmaceuticals Development, TA Cardiovascular, Bayer Pharma AG, Wuppertal, Germany.'}, {'ForeName': 'Helmi', 'Initials': 'H', 'LastName': 'Lutsep', 'Affiliation': 'Department of Neurology, Oregon Health and Science University, Portland.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Berkowitz', 'Affiliation': 'Thrombosis Group, Pharmaceuticals Research and Development, Bayer, Whippany, New Jersey.'}, {'ForeName': 'Mukul', 'Initials': 'M', 'LastName': 'Sharma', 'Affiliation': 'Division of Neurology, McMaster University / Population Health Research Institute, Hamilton, Ontario, Canada.'}]",JAMA neurology,['10.1001/jamaneurol.2020.3836']
1750,33074590,"Efficacy and safety of linagliptin as add-on therapy to insulin in Chinese patients with type 2 diabetes mellitus: A randomized, double-blind, placebo-controlled trial.","This 24-week, double-blind, placebo-controlled, phase III trial evaluated the efficacy and safety of linagliptin in 206 Chinese patients with inadequately controlled (glycated hemoglobin [HbA1c] 7.5-10.0%) type 2 diabetes mellitus (T2DM) receiving insulin (basal or premixed) ± metformin. Patients were randomized (1:1) to receive linagliptin 5 mg/day or placebo. The decrease from baseline in HbA1c (primary endpoint) was greater with linagliptin than placebo (-0.61% versus -0.20%; adjusted mean difference, -0.40%; P = 0.0016). Linagliptin demonstrated significantly greater improvement in 2-hour postprandial glucose (-31.95 mg/dL; P <0.001), and a numerical reduction in fasting plasma glucose (-6.2 mg/dL; P = 0.2241) versus placebo. Proportionally more patients on linagliptin achieved HbA1c ≥0.5% reduction versus placebo (odds ratio, 2.293; P <0.01). Adverse events in both groups were similar, with no new safety findings or clinically relevant changes in body weight. Among investigator-defined hypoglycemic events (linagliptin, 17.3%; placebo, 12.7%; odds ratio, 1.48; P = 0.337), none were severe. In Chinese patients with T2DM, linagliptin add-on to insulin improves glycemic control and is well tolerated, without increased risk for hypoglycemia or weight gain. This article is protected by copyright. All rights reserved.",2020,"Linagliptin demonstrated significantly greater improvement in 2-hour postprandial glucose (-31.95 mg/dL; P <0.001), and a numerical reduction in fasting plasma glucose (-6.2 mg/dL; P = 0.2241) versus placebo.","['206 Chinese patients with inadequately controlled (glycated hemoglobin [HbA1c] 7.5-10.0%) type 2 diabetes mellitus (T2DM) receiving', 'Chinese patients with type 2 diabetes mellitus', 'Chinese patients with']","['linagliptin 5 mg/day or placebo', 'T2DM, linagliptin', 'Linagliptin', 'placebo', 'linagliptin', 'insulin (basal or premixed) ± metformin']","['2-hour postprandial glucose', 'efficacy and safety', 'Adverse events', 'hypoglycemic events', 'Efficacy and safety', 'body weight', 'fasting plasma glucose']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C3153993', 'cui_str': 'Linagliptin 5 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C2746078', 'cui_str': 'Linagliptin'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C1292425', 'cui_str': '2 hours'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}]",206.0,0.519777,"Linagliptin demonstrated significantly greater improvement in 2-hour postprandial glucose (-31.95 mg/dL; P <0.001), and a numerical reduction in fasting plasma glucose (-6.2 mg/dL; P = 0.2241) versus placebo.","[{'ForeName': 'Wenying', 'Initials': 'W', 'LastName': 'Yang', 'Affiliation': ""China-Japan Friendship Hospital, Beijing, People's Republic of China.""}, {'ForeName': 'Xiangjin', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': ""The 900th Hospital of Joint Logistic Support Force, PLA, Fujian, People's Republic of China.""}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Lei', 'Affiliation': ""Putuo Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, People's Republic of China.""}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': ""Nanjing First Hospital, Nanjing Medical University, Nanjing, People's Republic of China.""}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': ""Shengjing Hospital of China Medical University Endocrinology, Liaoning, People's Republic of China.""}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Shen', 'Affiliation': ""Boehringer Ingelheim (China) Investment Co. Ltd, Shanghai, People's Republic of China.""}, {'ForeName': 'Binqi', 'Initials': 'B', 'LastName': 'Ye', 'Affiliation': ""Boehringer Ingelheim (China) Investment Co. Ltd, Shanghai, People's Republic of China.""}, {'ForeName': 'Sandy', 'Initials': 'S', 'LastName': 'Zhu', 'Affiliation': ""Boehringer Ingelheim (China) Investment Co. Ltd, Shanghai, People's Republic of China.""}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Meinicke', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14231']
1751,33074597,Copper nanoparticles as nanofillers in an adhesive resin system: An in vitro study.,"BACKGROUND


The incorporation of an antibacterial agent into an adhesive could improve its clinical performance. Some nanoparticles (NPs), including copper nanoparticles (Cu NPs), display an antibacterial effect. Therefore, Cu NPs could act as a nanofiller when added to an adhesive.
OBJECTIVES


The aim of this study was to evaluate the antibacterial activity, cytotoxicity and shear bond strength (SBS) of an experimental dental adhesive with Cu NPs.
MATERIAL AND METHODS


Different concentrations (0.0050 wt%, 0.0075 wt% and 0.0100 wt%) of Cu NPs were added to the adhesive. The distribution of Cu NPs in the polymer matrix was observed based on transmission electron microscope (TEM) images. The antimicrobial activity of the adhesive + Cu NPs was evaluated with the agar disk diffusion test against Staphylococcus aureus (S. aureus), Escherichia coli (E. coli) and Streptococcus mutans (S. mutans). The cytotoxicity assay was performed by means of the MTT (3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide) method with human pulp cells (HPC). Additionally, the SBS tests were carried out (n = 31) and the modes of fracture were registered. The vestibular and lingual surfaces of each tooth were randomly assigned to the study groups (group I - control adhesive; group II - adhesive + 0.0100 wt% Cu NPs). The samples were statistically analyzed (p ≤ 0.05).
RESULTS


The adhesive + 0.0100 wt% Cu NPs showed inhibition zones against the strains under study that were similar to, or slightly smaller than, the halos produced by chlorhexidine (CHX) and specific drugs for each strain (30 μg of cefotaxime against S. mutans and S. aureus, and 1.25/3.75 μg of sulfamethoxazole/ trimethoprim against E. coli). The control adhesive was moderately cytotoxic (relative cell viability of 36.7 ±0.8%), being more cytotoxic than Cu NPs themselves (58.3 ±0.1%). A significantly higher SBS was obtained for the adhesive + 0.0100 wt% Cu NPs (6.038 ±2.95 MPa) than for the control group (3.278 ±1.75 MPa). The modes of fracture in group I were almost equally distributed between adhesive and cohesive failures whereas in group II, the failure was mainly cohesive.
CONCLUSIONS


The results of this study suggest that incorporating Cu NPs into an adhesive improves its SBS and provides it with antibacterial properties, without increasing its inherent cytotoxicity - 2 desirable characteristics for the dental adhesives of composites.",2020,"The modes of fracture in group I were almost equally distributed between adhesive and cohesive failures whereas in group II, the failure was mainly cohesive.
",['adhesive resin system'],"['control adhesive; group II - adhesive + 0.0100 wt', 'adhesive ', 'MTT (3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide) method with human pulp cells (HPC', 'chlorhexidine (CHX']","['antimicrobial activity', 'antibacterial activity, cytotoxicity and shear bond strength (SBS', 'SBS']","[{'cui': 'C0001516', 'cui_str': 'Adhesive'}, {'cui': 'C0035191', 'cui_str': 'Resins, Plant'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001516', 'cui_str': 'Adhesive'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0647210', 'cui_str': 'monooxyethylene trimethylolpropane tristearate'}, {'cui': 'C0094912', 'cui_str': '3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0011399', 'cui_str': 'Structure of pulp of tooth'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}]","[{'cui': 'C1271650', 'cui_str': 'Antimicrobial activity'}, {'cui': 'C0279516', 'cui_str': 'Antibacterial'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0175735', 'cui_str': 'Scissors'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}]",31.0,0.028001,"The modes of fracture in group I were almost equally distributed between adhesive and cohesive failures whereas in group II, the failure was mainly cohesive.
","[{'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Torres-Rosas', 'Affiliation': 'Laboratory of Biomaterials, Center for Studies in Health and Disease Sciences, School of Dentistry, Benito Juárez Autonomous University of Oaxaca, Oaxaca de Juárez, Mexico.'}, {'ForeName': 'Nayely', 'Initials': 'N', 'LastName': 'Torres-Gómez', 'Affiliation': 'Technological Institute of Toluca, Metepec, Mexico.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'García-Contreras', 'Affiliation': 'Laboratory of Interdisciplinary Research, Area of Nanostructures and Biomaterials, National School of Higher Studies León Unit, National Autonomous University of Mexico, Mexico City, Mexico.'}, {'ForeName': 'Rogelio José', 'Initials': 'RJ', 'LastName': 'Scougall-Vilchis', 'Affiliation': 'Department of Orthodontics, Center for Research and Advanced Studies in Dentistry, Autonomous University of Mexico State, Mexico City, Mexico.'}, {'ForeName': 'Luis Roberto', 'Initials': 'LR', 'LastName': 'Domínguez-Díaz', 'Affiliation': 'National Technological Institute of Mexico, Mexico City, Mexico.'}, {'ForeName': 'Liliana', 'Initials': 'L', 'LastName': 'Argueta-Figueroa', 'Affiliation': 'Cátedras CONACYT - School of Dentistry, Benito Juárez Autonomous University of Oaxaca, Oaxaca de Juárez, Mexico.'}]",Dental and medical problems,['10.17219/dmp/121973']
1752,33069214,"Impact of galcanezumab on total pain burden: findings from phase 3 randomized, double-blind, placebo-controlled studies in patients with episodic or chronic migraine (EVOLVE-1, EVOLVE-2, and REGAIN trials).","BACKGROUND


Focus on the frequency of migraine pain may undervalue the total burden of migraine as pain duration and severity may present unique, additive burden. A composite measure of total pain burden (TPB; frequency, severity, and duration) may provide a more comprehensive characterization of pain burden and treatment response in patients with episodic migraine (EM) or chronic migraine (CM). The impact of galcanezumab versus placebo on TPB among patients with EM or CM was analyzed.
METHODS


Patients from randomized, double-blind, placebo-controlled episodic (two 6-month studies pooled) and chronic migraine (3-month) studies received once-monthly subcutaneous injection of galcanezumab 120 mg or placebo. A post hoc analysis of TPB for a given month was calculated as severity-weighted duration by multiplying duration (hours) and maximum pain severity (0 = none, 1 = mild, 2 = moderate, 3 = severe) of migraine for each day and summing these over the days in a month. Least square mean change from baseline in monthly TPB across Months 1-6 (EM, N = 444 galcanezumab, N = 894 placebo) and Months 1-3 (CM, N = 278 galcanezumab, N = 558 placebo) were compared using a mixed-model repeated measures model. Correlation of the Migraine Specific Quality of Life Questionnaire (MSQ) and Migraine Disability Assessment Scale (MIDAS) to TPB at baseline was assessed.
RESULTS


At baseline, the duration of migraine on a given migraine headache day accounted for the greatest unique proportion of variability (EM, 57.4% and CM, 61.1%) to TPB after adjusting for frequency of migraine headache days and maximum pain severity. The decrease from baseline in monthly TPB was greater with galcanezumab than placebo for patients with EM (68.6 versus 36.2) and CM (102.6 versus 44.4). The average percent reduction of TPB from baseline was significantly greater with galcanezumab compared with placebo in patients with EM (50.8% versus 17.2%) and CM (29.7% versus 11.0%). In patients with EM and CM, TPB correlated with MSQ total score (r = - 0.35 and r = - 0.37) and MIDAS (r = 0.34 and r = 0.32).
CONCLUSIONS


Greater reduction in TPB was seen in patients with EM and CM treated with galcanezumab 120 mg once-monthly injection relative to placebo. Discussing TPB supports patient-centric conversations regarding treatment expectations when clinicians are evaluating options for migraine prevention.
TRIAL REGISTRATION


ClinicalTrials.gov : # NCT02614183 (I5Q-MC-CGAG; EVOLVE-1), # NCT02614196 (I5Q-MC-CGAH; EVOLVE-2), and # NCT02614261 (I5Q-MC-CGAI; REGAIN) - all 3 trials were registered on 23 November 2015.",2020,"In patients with EM and CM, TPB correlated with MSQ total score (r = - 0.35 and r = - 0.37) and MIDAS (r = 0.34 and r = 0.32).
","['patients with episodic or chronic migraine (EVOLVE-1, EVOLVE-2, and REGAIN trials', 'patients with EM or CM was analyzed', 'patients with episodic migraine (EM) or chronic migraine (CM']","['galcanezumab versus placebo', 'placebo-controlled episodic', 'galcanezumab', 'placebo', 'galcanezumab 120\u2009mg or placebo']","['total pain burden', 'duration of migraine on a given migraine headache', 'migraine headache days and maximum pain severity', 'MSQ total score', 'total pain burden (TPB; frequency, severity, and duration', 'Migraine Specific Quality of Life Questionnaire (MSQ) and Migraine Disability Assessment Scale (MIDAS) to TPB', 'TPB', 'monthly TPB', 'severity-weighted duration by multiplying duration (hours) and maximum pain severity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C1960870', 'cui_str': 'Transformed migraine'}, {'cui': 'C0332253', 'cui_str': 'Evolving'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4760993', 'cui_str': 'Episodic migraine'}]","[{'cui': 'C4694273', 'cui_str': 'galcanezumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C4319550', 'cui_str': '120'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C3854497', 'cui_str': 'Disability assessment scale'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1719797', 'cui_str': 'Multiply'}]",,0.524674,"In patients with EM and CM, TPB correlated with MSQ total score (r = - 0.35 and r = - 0.37) and MIDAS (r = 0.34 and r = 0.32).
","[{'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Ailani', 'Affiliation': 'Georgetown University, 3800 Reservoir Rd NW, Washington, DC, 20007, USA. Jessica.X.Ailani@gunet.georgetown.edu.'}, {'ForeName': 'J Scott', 'Initials': 'JS', 'LastName': 'Andrews', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Mallikarjuna', 'Initials': 'M', 'LastName': 'Rettiganti', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Nicholson', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}]",The journal of headache and pain,['10.1186/s10194-020-01190-7']
1753,33069281,"Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBIBP-CorV: a randomised, double-blind, placebo-controlled, phase 1/2 trial.","BACKGROUND


The ongoing COVID-19 pandemic warrants accelerated efforts to test vaccine candidates. We aimed to assess the safety and immunogenicity of an inactivated severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine candidate, BBIBP-CorV, in humans.
METHODS


We did a randomised, double-blind, placebo-controlled, phase 1/2 trial at Shangqiu City Liangyuan District Center for Disease Control and Prevention in Henan Province, China. In phase 1, healthy people aged 18-80 years, who were negative for serum-specific IgM/IgG antibodies against SARS-CoV-2 at the time of screening, were separated into two age groups (18-59 years and ≥60 years) and randomly assigned to receive vaccine or placebo in a two-dose schedule of 2 μg, 4 μg, or 8 μg on days 0 and 28. In phase 2, healthy adults (aged 18-59 years) were randomly assigned (1:1:1:1) to receive vaccine or placebo on a single-dose schedule of 8 μg on day 0 or on a two-dose schedule of 4 μg on days 0 and 14, 0 and 21, or 0 and 28. Participants within each cohort were randomly assigned by stratified block randomisation (block size eight) and allocated (3:1) to receive vaccine or placebo. Group allocation was concealed from participants, investigators, and outcome assessors. The primary outcomes were safety and tolerability. The secondary outcome was immunogenicity, assessed as the neutralising antibody responses against infectious SARS-CoV-2. This study is registered with www.chictr.org.cn, ChiCTR2000032459.
FINDINGS


In phase 1, 192 participants were enrolled (mean age 53·7 years [SD 15·6]) and were randomly assigned to receive vaccine (2 μg [n=24], 4 μg [n=24], or 8 μg [n=24] for both age groups [18-59 years and ≥60 years]) or placebo (n=24). At least one adverse reaction was reported within the first 7 days of inoculation in 42 (29%) of 144 vaccine recipients. The most common systematic adverse reaction was fever (18-59 years, one [4%] in the 2 μg group, one [4%] in the 4 μg group, and two [8%] in the 8 μg group; ≥60 years, one [4%] in the 8 μg group). All adverse reactions were mild or moderate in severity. No serious adverse event was reported within 28 days post vaccination. Neutralising antibody geometric mean titres were higher at day 42 in the group aged 18-59 years (87·7 [95% CI 64·9-118·6], 2 μg group; 211·2 [158·9-280·6], 4 μg group; and 228·7 [186·1-281·1], 8 μg group) and the group aged 60 years and older (80·7 [65·4-99·6], 2 μg group; 131·5 [108·2-159·7], 4 μg group; and 170·87 [133·0-219·5], 8 μg group) compared with the placebo group (2·0 [2·0-2·0]). In phase 2, 448 participants were enrolled (mean age 41·7 years [SD 9·9]) and were randomly assigned to receive the vaccine (8 μg on day 0 [n=84] or 4 μg on days 0 and 14 [n=84], days 0 and 21 [n=84], or days 0 and 28 [n=84]) or placebo on the same schedules (n=112). At least one adverse reaction within the first 7 days was reported in 76 (23%) of 336 vaccine recipients (33 [39%], 8 μg day 0; 18 [21%], 4 μg days 0 and 14; 15 [18%], 4 μg days 0 and 21; and ten [12%], 4 μg days 0 and 28). One placebo recipient in the 4 μg days 0 and 21 group reported grade 3 fever, but was self-limited and recovered. All other adverse reactions were mild or moderate in severity. The most common systematic adverse reaction was fever (one [1%], 8 μg day 0; one [1%], 4 μg days 0 and 14; three [4%], 4 μg days 0 and 21; two [2%], 4 μg days 0 and 28). The vaccine-elicited neutralising antibody titres on day 28 were significantly greater in the 4 μg days 0 and 14 (169·5, 95% CI 132·2-217·1), days 0 and 21 (282·7, 221·2-361·4), and days 0 and 28 (218·0, 181·8-261·3) schedules than the 8 μg day 0 schedule (14·7, 11·6-18·8; all p<0·001).
INTERPRETATION


The inactivated SARS-CoV-2 vaccine, BBIBP-CorV, is safe and well tolerated at all tested doses in two age groups. Humoral responses against SARS-CoV-2 were induced in all vaccine recipients on day 42. Two-dose immunisation with 4 μg vaccine on days 0 and 21 or days 0 and 28 achieved higher neutralising antibody titres than the single 8 μg dose or 4 μg dose on days 0 and 14.
FUNDING


National Program on Key Research Project of China, National Mega projects of China for Major Infectious Diseases, National Mega Projects of China for New Drug Creation, and Beijing Science and Technology Plan.",2020,"Neutralising antibody geometric mean titres were higher at day 42 in the group aged 18-59 years (87·7 [95% CI 64·9-118·6], 2 μg group; 211·2 [158·9-280·6], 4 μg group; and 228·7 [186·1-281·1], 8 μg group) and the group aged 60 years and older (80·7 [65·4-99·6], 2 μg group; 131·5 [108·2-159·7], 4 μg group; and 170·87 [133·0-219·5], 8 μg group) compared with the placebo group (2·0","['192 participants were enrolled (mean age 53·7 years [SD 15·6', 'n=24], 4 μg [n=24], or 8 μg [n=24] for both age groups [18-59 years and ≥60 years]) or', 'group (2·0', 'n=84] or 4 μg on days 0 and 14 [n=84], days 0 and 21 [n=84], or days 0 and 28 [n=84]) or', '448 participants were enrolled (mean age 41·7 years [SD 9·9', 'n=24', 'healthy adults (aged 18-59 years', 'group aged 60 years and older (80·7 [65·4-99·6], 2 μg group; 131·5 [108·2-159·7], 4 μg group; and 170·87 [133·0-219·5], 8 μg group) compared with the', 'Shangqiu City Liangyuan District Center for Disease Control and Prevention in Henan Province, China', 'healthy people aged 18-80 years, who were negative for serum-specific IgM/IgG antibodies against SARS-CoV-2 at the time of screening, were separated into two age groups (18-59 years and ≥60 years']","['inactivated SARS-CoV-2 vaccine', 'vaccine', 'placebo', 'vaccine or placebo']","['Safety and immunogenicity', 'safety and tolerability', 'neutralising antibody responses against infectious SARS-CoV-2', ' BBIBP-CorV', 'grade 3 fever', 'neutralising antibody titres', 'safe and well tolerated', 'Neutralising antibody geometric mean titres', 'adverse reaction', 'serious adverse event', 'Humoral responses against SARS-CoV-2', 'safety and immunogenicity']","[{'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0007670', 'cui_str': 'Centers for Disease Control and Prevention (U.S.)'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0020861', 'cui_str': 'Immunoglobulin M'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0443299', 'cui_str': 'Separate'}]","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0475463', 'cui_str': 'Neutralizing antibody'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",448.0,0.626224,"Neutralising antibody geometric mean titres were higher at day 42 in the group aged 18-59 years (87·7 [95% CI 64·9-118·6], 2 μg group; 211·2 [158·9-280·6], 4 μg group; and 228·7 [186·1-281·1], 8 μg group) and the group aged 60 years and older (80·7 [65·4-99·6], 2 μg group; 131·5 [108·2-159·7], 4 μg group; and 170·87 [133·0-219·5], 8 μg group) compared with the placebo group (2·0","[{'ForeName': 'Shengli', 'Initials': 'S', 'LastName': 'Xia', 'Affiliation': 'Henan Provincial Center for Disease Control and Prevention, Henan, China.'}, {'ForeName': 'Yuntao', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Beijing Institute of Biological Products, Beijing, China.'}, {'ForeName': 'Yanxia', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Henan Provincial Center for Disease Control and Prevention, Henan, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Beijing Institute of Biological Products, Beijing, China.'}, {'ForeName': 'Yunkai', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Beijing Institute of Biological Products, Beijing, China.'}, {'ForeName': 'George Fu', 'Initials': 'GF', 'LastName': 'Gao', 'Affiliation': 'Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Wenjie', 'Initials': 'W', 'LastName': 'Tan', 'Affiliation': 'Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Guizhen', 'Initials': 'G', 'LastName': 'Wu', 'Affiliation': 'Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Miao', 'Initials': 'M', 'LastName': 'Xu', 'Affiliation': 'National Institute for Food and Drug Control, Beijing, China.'}, {'ForeName': 'Zhiyong', 'Initials': 'Z', 'LastName': 'Lou', 'Affiliation': 'MOE Key Laboratory of Protein Science & Collaborative Innovation Center of Biotherapy, School of Medicine, Tsinghua University, Beijing, China.'}, {'ForeName': 'Weijin', 'Initials': 'W', 'LastName': 'Huang', 'Affiliation': 'National Institute for Food and Drug Control, Beijing, China.'}, {'ForeName': 'Wenbo', 'Initials': 'W', 'LastName': 'Xu', 'Affiliation': 'Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Baoying', 'Initials': 'B', 'LastName': 'Huang', 'Affiliation': 'Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Huijuan', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Beijing Institute of Biological Products, Beijing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Beijing Institute of Biological Products, Beijing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Henan Provincial Center for Disease Control and Prevention, Henan, China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'Beijing Institute of Biological Products, Beijing, China.'}, {'ForeName': 'Zhiqiang', 'Initials': 'Z', 'LastName': 'Xie', 'Affiliation': 'Henan Provincial Center for Disease Control and Prevention, Henan, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Ding', 'Affiliation': 'Beijing Institute of Biological Products, Beijing, China.'}, {'ForeName': 'Wangyang', 'Initials': 'W', 'LastName': 'You', 'Affiliation': 'Henan Provincial Center for Disease Control and Prevention, Henan, China.'}, {'ForeName': 'Yuxiu', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Beijing Institute of Biological Products, Beijing, China.'}, {'ForeName': 'Xuqin', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Beijing Institute of Biological Products, Beijing, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Beijing Institute of Biological Products, Beijing, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Beijing Institute of Biological Products, Beijing, China.'}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': 'Henan Provincial Center for Disease Control and Prevention, Henan, China.'}, {'ForeName': 'Yongli', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Epidemiology and Biostatistics, College of Public Health, Zhengzhou University, Zhengzhou, Henan, China.'}, {'ForeName': 'Guangxue', 'Initials': 'G', 'LastName': 'Xu', 'Affiliation': 'MOE Key Laboratory of Protein Science & Collaborative Innovation Center of Biotherapy, School of Medicine, Tsinghua University, Beijing, China.'}, {'ForeName': 'Bojian', 'Initials': 'B', 'LastName': 'Luo', 'Affiliation': 'Beijing Zhongsheng Hengyi Pharmaceutical Technology, Beijing, China.'}, {'ForeName': 'Wenling', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Peipei', 'Initials': 'P', 'LastName': 'Liu', 'Affiliation': 'Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Wanshen', 'Initials': 'W', 'LastName': 'Guo', 'Affiliation': 'Henan Provincial Center for Disease Control and Prevention, Henan, China. Electronic address: cdcgws@163.com.'}, {'ForeName': 'Xiaoming', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Beijing Institute of Biological Products, Beijing, China. Electronic address: yangxiaoming@sinopharm.com.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(20)30831-8']
1754,33081705,Sleep-HD trial: short and long-term effectiveness of existing insomnia therapies for patients undergoing hemodialysis.,"BACKGROUND


Patients with end-stage kidney disease (ESKD) treated with hemodialysis (HD) experience many distressing symptoms. One frequently reported symptom is insomnia. There are unique issues about HD treatments and schedules that disrupt regular sleep/wake routines and possibly contribute to the high severity of insomnia. Despite evidence for broad-ranging health effects of insomnia, very few clinical trials have tested the efficacy of treatments for HD patients. Cognitive-behavioral therapy for insomnia (CBT-I) is a recommended first-line therapy but largely inaccessible to HD patients in the United States, partly because they commit considerable amounts of time to thrice-weekly dialysis treatments. Another important reason could be the logistical and reimbursement challenges associated with providing behavioral health care at the dialysis center. CBT-I delivered by telehealth can overcome barriers to access, but its efficacy has never been rigorously tested for these patients. Pharmacotherapy is the most widely used treatment for insomnia; however, some drugs presently used are unsafe as they are associated with a higher risk for death for HD patients (benzodiazepines and zolpidem-like drugs). The efficacy and safety of other medications (trazodone) for the treatment of insomnia has never been tested for patients treated with HD.
METHODS


This trial tests the short- and long-term comparative effectiveness of 6-week treatment with telehealth CBT-I, trazodone, or medication placebo. This will be accomplished with a randomized controlled trial (RCT) in which 126 participants treated with HD in community-based dialysis facilities with chronic insomnia will be assigned 1:1:1 to telehealth CBT-I, trazodone, or medication placebo, respectively; short-term effectiveness of each treatment arm will be determined at the end of 6-weeks of treatment and long-term effectiveness at 25-weeks. The primary and secondary patient-reported outcomes will be assessed with computer-based telephone interviewing by research scientists blinded to treatment assignment; additional secondary outcomes will be assessed by participant interview and actigraphy.
DISCUSSION


This clinical RCT will provide the first evidence for the comparative effectiveness of two distinct approaches for treating chronic insomnia and other patient-reported outcomes for patients receiving maintenance HD.
TRIAL REGISTRATION


NCT03534284 May 23, 2018. SLEEP-HD Protocol Version: 1.3.4 (7/22/2020).",2020,"CBT-I delivered by telehealth can overcome barriers to access, but its efficacy has never been rigorously tested for these patients.","['Patients with end-stage kidney disease (ESKD) treated with hemodialysis (HD) experience many distressing symptoms', '126 participants treated with HD in community-based dialysis facilities with chronic insomnia', 'patients receiving maintenance HD', 'HD patients', 'patients undergoing hemodialysis', 'patients treated with HD']","['existing insomnia therapies', 'medications (trazodone', 'telehealth CBT-I, trazodone, or medication placebo', 'trazodone, or medication placebo', 'Cognitive-behavioral therapy']",['efficacy and safety'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0751249', 'cui_str': 'Chronic insomnia'}, {'cui': 'C4040576', 'cui_str': 'Maintenance hemodialysis'}]","[{'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0040805', 'cui_str': 'Trazodone'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0569076,"CBT-I delivered by telehealth can overcome barriers to access, but its efficacy has never been rigorously tested for these patients.","[{'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Unruh', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, University of New Mexico, Albuquerque, NM, USA. MUnruh@salud.unm.edu.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Cukor', 'Affiliation': 'The Rogosin Institute, New York, NY, USA.'}, {'ForeName': 'Tessa', 'Initials': 'T', 'LastName': 'Rue', 'Affiliation': 'Center for Biomedical Statistics, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Kashif', 'Initials': 'K', 'LastName': 'Abad', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, University of New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'Maria-Eleni', 'Initials': 'ME', 'LastName': 'Roumelioti', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, University of New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'McCurry', 'Affiliation': 'Child, Family, and Population Health Nursing, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Heagerty', 'Affiliation': 'Center for Biomedical Statistics, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Rajnish', 'Initials': 'R', 'LastName': 'Mehrotra', 'Affiliation': 'Division of Nephrology, Kidney Research Institute, University of Washington, Seattle, WA, USA.'}]",BMC nephrology,['10.1186/s12882-020-02107-x']
1755,33081715,The MIPAM trial: a 12-week intervention with motivational interviewing and physical activity monitoring to enhance the daily amount of physical activity in community-dwelling older adults - a study protocol for a randomized controlled trial.,"BACKGROUND


Physical Activity Monitors (PAMs) have been shown to effectively enhance level of physical activity (PA) in older adults. Motivational interviewing is a person-centred model where participants are guided using self-reflection and counselling, and addresses the behavioural and psychological aspects of why people initiate health behaviour change by prompting increases in motivation and self-efficacy. The addition of motivational interviewing to PA interventions may increase the effectiveness of PAMs for older adults.
METHODS


This motivational interviewing and PA monitoring trial is designed as an investigator-blinded, two arm parallel group, randomized controlled superiority trial with primary endpoint after 12 weeks of intervention. The intervention group will receive a PAM-based intervention and motivational interviewing and the control group will only receive the PAM-based intervention. The primary outcome is PA, objectively measured as the average daily number of steps throughout the intervention period. Secondary outcome measures include self-reported PA health-related quality of life, loneliness, self-efficacy for exercise, outcome expectancy for exercise, and social relations. The outcomes will be analysed with a linear regression model investigating between-group differences, adjusted for baseline scores. Following the intention to treat principle, multiple imputation will be performed to handle missing values.
DISCUSSION


A moderate effect of daily PA measured using PAMs is expected in this superiority RCT investigating the effect of adding motivational interviewing to a PAM intervention. According to the World Health Organization, walking and cycling are key activities in regular PA and should be promoted. To increase the general public health and lower the burden of inactivity in older adults, cost-beneficial solutions should be investigated further. If this RCT shows that motivational interviewing can enhance the effect of PAM-based interventions, it might be included as an add-on intervention when appropriate. No matter what the results of this study will be, the conclusions will be relevant for clinicians as the dependence on technology is increasing, especially in relation to public health promotion.
TRIAL REGISTRATION


NCT03906162 , April 1, 2019.",2020,"Secondary outcome measures include self-reported PA health-related quality of life, loneliness, self-efficacy for exercise, outcome expectancy for exercise, and social relations.","['older adults', 'community-dwelling older adults']","['Physical Activity Monitors (PAMs', 'motivational interviewing and physical activity monitoring to enhance the daily amount of physical activity', 'Motivational interviewing', 'PAM-based intervention and motivational interviewing and the control group will only receive the PAM-based intervention', 'motivational interviewing to PA interventions']","['general public health', 'PA, objectively measured as the average daily number of steps', 'self-reported PA health-related quality of life, loneliness, self-efficacy for exercise, outcome expectancy for exercise, and social relations']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2931826', 'cui_str': 'Potassium aggravated myotonia'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0080103', 'cui_str': 'Relative'}]",,0.0699643,"Secondary outcome measures include self-reported PA health-related quality of life, loneliness, self-efficacy for exercise, outcome expectancy for exercise, and social relations.","[{'ForeName': 'Rasmus Tolstrup', 'Initials': 'RT', 'LastName': 'Larsen', 'Affiliation': 'Department of Public Health, Section of Social Medicine, University of Copenhagen, Copenhagen, Denmark. rala@sund.ku.dk.'}, {'ForeName': 'Christoffer Bruun', 'Initials': 'CB', 'LastName': 'Korfitsen', 'Affiliation': 'Department of Public Health, Section of Social Medicine, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Carsten Bogh', 'Initials': 'CB', 'LastName': 'Juhl', 'Affiliation': 'Research Unit of Musculoskeletal Function and Physiotherapy, Institute of Sports Science and Clinical Biomechanics, Faculty of Health Sciences, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Henning Boje', 'Initials': 'HB', 'LastName': 'Andersen', 'Affiliation': 'Technical University of Denmark, DTU Management Engineering Inst, Lyngby, Denmark.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Christensen', 'Affiliation': 'Department of Occupational- and Physiotherapy, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Langberg', 'Affiliation': 'Department of Public Health, Section for Health Services Research, University of Copenhagen, Copenhagen, Denmark.'}]",BMC geriatrics,['10.1186/s12877-020-01815-1']
1756,33081717,A hypocaloric high-protein diet supplemented with β-cryptoxanthin improves non-alcoholic fatty liver disease: a randomized controlled trial.,"BACKGROUND


Despite promising animal data, there is no randomized controlled trial (RCT) on the effects of high protein (HP)-diet and/or β-cryptoxanthin in non-alcoholic fatty liver disease (NAFLD).
AIMS


Safety and efficacy assessment of a hypocaloric HP-diet supplemented with β-cryptoxanthin in NAFLD.
METHODS


Ninety-two Iranian NAFLD outpatients were recruited for this 12-week, single-center, parallel-group, double-blind RCT and randomized into 4 arms (n = 23): HP-diet and β-cryptoxanthin (hypocaloric HP-diet + β-cryptoxanthin), HP-diet (hypocaloric HP-diet + placebo), β-cryptoxanthin (standard hypocaloric diet + β-cryptoxanthin), and control (standard hypocaloric diet + placebo). Serum levels of liver enzymes and grade of hepatic steatosis were assessed at baseline and study endpoint as outcome measures.
RESULTS


In the intention-to-treat population (N = 92), HP-diet and β-cryptoxanthin group experienced greater 12-week reductions in serum levels of liver enzymes than control group (mean difference for alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, and gamma-glutamyl transferase: - 27.2, - 7.2, - 39.2, and - 16.3 IU/L, respectively; all p < 0.010). Clinical remission rate (achieving grade 0 hepatic steatosis) in HP-diet and β-cryptoxanthin group (82.6%) was also higher than other groups (13.0%, 17.4%, and 0.0% in HP-diet, β-cryptoxanthin, and control groups, respectively; p < 0.001). Sixteen patients reported minor adverse events.
CONCLUSION


A hypocaloric HP-diet supplemented with β-cryptoxanthin safely and efficaciously improves NAFLD.
TRIAL REGISTRATION NUMBER


This trial was registered at https://www.irct.ir as IRCT2017060210181N10.",2020,"Sixteen patients reported minor adverse events.
","['non-alcoholic fatty liver disease (NAFLD', 'Ninety-two Iranian NAFLD outpatients']","['hypocaloric HP-diet supplemented with β-cryptoxanthin', 'high protein ', 'HP-diet and β-cryptoxanthin (hypocaloric HP-diet\u2009+\u2009β-cryptoxanthin), HP-diet (hypocaloric HP-diet\u2009+\u2009placebo), β-cryptoxanthin (standard hypocaloric diet\u2009+\u2009β-cryptoxanthin), and control (standard hypocaloric diet\u2009+\u2009placebo', 'HP-diet and β-cryptoxanthin', 'hypocaloric high-protein diet supplemented with β-cryptoxanthin', 'HP)-diet', 'β-cryptoxanthin']","['non-alcoholic fatty liver disease', 'Serum levels of liver enzymes and grade of hepatic steatosis', 'minor adverse events', 'alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, and gamma-glutamyl transferase', 'Clinical remission rate', 'serum levels of liver enzymes']","[{'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}]","[{'cui': 'C0425403', 'cui_str': 'Increased protein diet'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C3850081', 'cui_str': 'Cryptoxanthin'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0015695', 'cui_str': 'Fatty Liver'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0002059', 'cui_str': 'Alkaline phosphatase'}, {'cui': 'C0017040', 'cui_str': 'Gamma-glutamyltransferase'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}]",92.0,0.115261,"Sixteen patients reported minor adverse events.
","[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Haidari', 'Affiliation': 'Department of Nutrition Sciences, Nutrition and Metabolic Diseases Research Center, School of Paramedical Sciences, Ahvaz Jundishapur University of Medical Sciences, 61357-15794, Ahvaz, Iran.'}, {'ForeName': 'Abdollah', 'Initials': 'A', 'LastName': 'Hojhabrimanesh', 'Affiliation': 'Department of Nutrition Sciences, Nutrition and Metabolic Diseases Research Center, School of Paramedical Sciences, Ahvaz Jundishapur University of Medical Sciences, 61357-15794, Ahvaz, Iran. hozhabri.a@ajums.ac.ir.'}, {'ForeName': 'Bizhan', 'Initials': 'B', 'LastName': 'Helli', 'Affiliation': 'Department of Nutrition Sciences, Nutrition and Metabolic Diseases Research Center, School of Paramedical Sciences, Ahvaz Jundishapur University of Medical Sciences, 61357-15794, Ahvaz, Iran.'}, {'ForeName': 'Seyed-Saeed', 'Initials': 'SS', 'LastName': 'Seyedian', 'Affiliation': 'Department of Gastroenterology, School of Medicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Kambiz', 'Initials': 'K', 'LastName': 'Ahmadi-Angali', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Health, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Behnaz', 'Initials': 'B', 'LastName': 'Abiri', 'Affiliation': 'Department of Nutrition, Faculty of Paramedicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}]",BMC gastroenterology,['10.1186/s12876-020-01502-w']
1757,33081736,Implementation outcomes of a culturally adapted diabetes self-management education intervention for Native Hawaiians and Pacific islanders.,"BACKGROUND


Native Hawaiians and Pacific Islanders (NHPIs) experience a disproportionate burden of type 2 diabetes and related complications. Although diabetes self-management education and support (DSMES) interventions have generally yielded positive results, few NHPIs have been included in these studies, and even fewer studies have been evaluated using a randomized controlled trial design and/or implementation research methods. The purpose of this pilot study was to evaluate implementation outcomes of a culturally adapted diabetes self-management education intervention delivered by peer educators to Native Hawaiians and Pacific Islanders residing in Honolulu, Hawai'i.
METHODS


In three study sites, the peer educators and 48 participants randomized to the intervention were invited to participate in the mixed methods implementation research. We used a convergent parallel design to collect implementation data including fidelity, feasibility, acceptability, appropriateness, adoption, and sustainability. Data were collected from class observations, participants' class feedback, and post-intervention focus groups with participants and peer educators.
RESULTS


In 314 end-of-class feedback surveys, 97% of respondents expressed that they were satisfied or highly satisfied with the class content and activities, 98% reported that the classes and materials were very useful, 94% reported very applicable, and 93% reported materials were culturally appropriate. Respondents identified several aspects of the program as especially enjoyable: interactions with peer educators, meeting in groups, learning about other participants' experiences with diabetes, and the information presented in each class. Major themes that emerged from the end-of-intervention focus groups were the relevance of the educational materials, strategies to manage blood glucose, hands-on activities, cultural aspects of the program, including the stories and analogies used to convey information, and appreciation of the group format and peer educators.
CONCLUSIONS


Results from this research support a culturally tailored, peer educator approach to DSMES among NHPIs. Delivery of the Partners in Care program is feasible in health care and community settings and is a reimbursable DSMES program.
TRIAL REGISTRATION


Clinicaltrials.gov Identifier: NCT01093924 prospectively registered 01.20.09.",2020,"Delivery of the Partners in Care program is feasible in health care and community settings and is a reimbursable DSMES program.
",['Native Hawaiians and Pacific islanders'],"[""culturally adapted diabetes self-management education intervention delivered by peer educators to Native Hawaiians and Pacific Islanders residing in Honolulu, Hawai'i"", 'culturally adapted diabetes self-management education intervention']","['relevance of the educational materials, strategies to manage blood glucose, hands-on activities, cultural aspects of the program, including the stories and analogies used to convey information, and appreciation of the group format and peer educators', 'fidelity, feasibility, acceptability, appropriateness, adoption, and sustainability']","[{'cui': 'C0337920', 'cui_str': 'Hawaiians'}, {'cui': 'C0242191', 'cui_str': 'Pacific Island Americans'}]","[{'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C1319140', 'cui_str': 'Diabetes self-management behavior'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0337920', 'cui_str': 'Hawaiians'}, {'cui': 'C0242191', 'cui_str': 'Pacific Island Americans'}, {'cui': 'C0018619', 'cui_str': 'Hawaii state'}]","[{'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0220814', 'cui_str': 'culture'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1301627', 'cui_str': 'Format'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0001593', 'cui_str': 'Adoption'}]",,0.0480082,"Delivery of the Partners in Care program is feasible in health care and community settings and is a reimbursable DSMES program.
","[{'ForeName': 'Kaʻimi A', 'Initials': 'KA', 'LastName': 'Sinclair', 'Affiliation': 'Institute for Research and Education to Advance Community Health, College of Nursing, Washington State University, 1100 Olive Way, Suite 1200, Seattle, WA, 98101, USA. Kaimi.sinclair@wsu.edu.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Zamora-Kapoor', 'Affiliation': 'Institute for Research and Education to Advance Community Health, Washington State University, 1100 Olive Way, Suite 1200, Seattle, WA, 98101, USA.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Townsend-Ing', 'Affiliation': ""Department of Native Hawaiian Health, John A. Burns School of Medicine, University of Hawai'i, 677 Ala Moana Blvd, Suite 1016, Honolulu, Hawai'i, 96813, USA.""}, {'ForeName': 'Pearl A', 'Initials': 'PA', 'LastName': 'McElfish', 'Affiliation': 'University of Arkansas Medical Sciences, 1125 N. College Avenue, Fayetteville, AR, 72703-1908, USA.'}, {'ForeName': 'Joseph Keaweʻaimoku', 'Initials': 'JK', 'LastName': 'Kaholokula', 'Affiliation': ""Department of Native Hawaiian Health, John A. Burns School of Medicine, University of Hawai'i, 677 Ala Moana Blvd, Suite 1016, Honolulu, Hawai'i, 96813, USA.""}]",BMC public health,['10.1186/s12889-020-09690-6']
1758,33081903,[Application of folding transfer shelf in the transportation of critically ill patients].,"OBJECTIVE


To explore the application of folding transfer shelf in the transportation of critically ill patients.
METHODS


Patients transferred from the emergency department to the intensive care unit (ICU) admitted to the First Hospital of Jiaxing from January 1st to December 31st in 2019 were enrolled. The patients were divided into study group and control group by whether or not using the self-developed folding transfer shelf. The incidence of adverse events, the stability rate of vital signs and the transport time were compared between the two group.
RESULTS


A total of 437 patients were enrolled in the study, with 222 in the study group (which used the self-developed folding transfer shelf) and 215 in the control group (which used the conventional stretcher). The baseline data such as gender, age, disease status and disease severity were balanced between the two groups. The stability rate of vital signs in the study group was higher than that in the control group (89.19% vs. 82.33%, P < 0.05). The transfer time in the study group was shorter than that in the control group (minutes: 6.39±1.35 vs. 7.61±1.34, P < 0.01). The total incidence of adverse transport events in the study group was lower than that in the control group (2.25% vs. 10.23%, P < 0.01). The incidence of miscarriage of emergent materials and instrument falling in the study group were lower than those in the control group (0% vs. 2.79%, 0% vs. 2.33%, both P < 0.05).
CONCLUSIONS


The folding transfer shelf could reduce the transport risk of critical ill patients, especially the risk of miscarriage and falling of rescue instrument. The application of folding transfer shelf could regulate the management of transport, keep the vital signs of patients stable during transport, shorten the transport time, and facilitate an efficient and high-quality transport.",2020,"The incidence of miscarriage of emergent materials and instrument falling in the study group were lower than those in the control group (0% vs. 2.79%, 0% vs. 2.33%, both P < 0.05).
","['A total of 437 patients were enrolled in the study, with 222 in the study group (which used the self-developed folding transfer shelf) and 215 in the control group (which used the conventional stretcher', 'Patients transferred from the emergency department to the intensive care unit (ICU) admitted to the First Hospital of Jiaxing from January 1st to December 31st in 2019 were enrolled', 'critically ill patients']",[],"['total incidence of adverse transport events', 'stability rate of vital signs', 'incidence of miscarriage of emergent materials and instrument falling', 'transfer time', 'incidence of adverse events, the stability rate of vital signs and the transport time']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0185026', 'cui_str': 'Plication'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C4709308', 'cui_str': '215'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0150789', 'cui_str': 'Stretcher'}, {'cui': 'C0030704', 'cui_str': 'Patient transfer'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205435', 'cui_str': 'First'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}]",[],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0005528', 'cui_str': 'Biological transport'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",437.0,0.0167764,"The incidence of miscarriage of emergent materials and instrument falling in the study group were lower than those in the control group (0% vs. 2.79%, 0% vs. 2.33%, both P < 0.05).
","[{'ForeName': 'Xianjiang', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Intensive Care Unit, First Hospital of Jiaxing, Jiaxing 314000, Zhejiang, China. Corresponding author: Cheng Junya, Email: 812762418@qq.com.'}, {'ForeName': 'Junya', 'Initials': 'J', 'LastName': 'Cheng', 'Affiliation': ''}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': ''}, {'ForeName': 'Dongmei', 'Initials': 'D', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Yunchao', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': ''}, {'ForeName': 'Huijie', 'Initials': 'H', 'LastName': 'Yu', 'Affiliation': ''}]",Zhonghua wei zhong bing ji jiu yi xue,['10.3760/cma.j.cn121430-20200310-00212']
1759,33081982,"A plant-based meal affects thalamus perfusion differently than an energy- and macronutrient-matched conventional meal in men with type 2 diabetes, overweight/obese, and healthy men: A three-group randomized crossover study.","BACKGROUND & AIMS


Reward circuitry in the brain plays a key role in weight regulation. We tested the effects of a plant-based meal on these brain regions.
METHODS


A randomized crossover design was used to test the effects of two energy- and macronutrient-matched meals: a vegan (V-meal) and a conventional meat (M-meal) on brain activity, gastrointestinal hormones, and satiety in participants with type 2 diabetes (T2D; n = 20), overweight/obese participants (O; n = 20), and healthy controls (H; n = 20). Brain perfusion was measured, using arterial spin labeling functional brain imaging; satiety was assessed using a visual analogue scale; and plasma concentrations of gut hormones were determined at 0 and 180 min. Repeated-measures ANOVA was used for statistical analysis. Bonferroni correction for multiple comparisons was applied. The Hedge's g statistic was used to measure the effect size for means of paired difference between the times (180-0 min) and meal types (M-V meal) for each group.
RESULTS


Thalamus perfusion was the highest in patients with T2D and the lowest in overweight/obese individuals (p = 0.001). Thalamus perfusion decreased significantly after ingestion of the M-meal in men with T2D (p = 0.04) and overweight/obese men (p = 0.004), and it decreased significantly after ingestion of the V-meal in healthy controls (p < 0.001; Group x Meal x Time: F = 3.4; p = 0.035). The effect size was -0.41 (95% CI, -1.14 to 0.31; p = 0.26) for men with diabetes; -0.72 (95% CI, -1.48 to 0.01; p = 0.05) for overweight/obese men; and 0.82 (95% CI, 0.09 to 1.59; p = 0.03) for healthy men. Postprandial secretion of active GLP-1 increased after the V-meal compared with the M-meal by 42% (95% CI 25-62%; p = 0.003) in men with T2D and by 41% (95% CI 24-61%; p = 0.002) in healthy controls. Changes in thalamus perfusion after ingestion of both test meals correlated with changes in satiety (r = +0.68; p < 0.01), fasting plasma insulin (r = +0.40; p < 0.01), C-peptide (r = +0.48; p < 0.01) and amylin (r = +0.55; p < 0.01), and insulin secretion at 5 mmol/l (r = +0.77; p < 0.05).
CONCLUSIONS


The higher postprandial GLP-1 secretion after the V-meal in men with T2D, with concomitant greater satiety and changes in thalamus perfusion, suggest a potential use of plant-based meals in addressing the key pathophysiologic mechanisms of food intake regulation. Trial registration ClinicalTrials.gov number, NCT02474147.",2020,"Thalamus perfusion decreased significantly after ingestion of the M-meal in men with T2D (p = 0.04) and overweight/obese men (p = 0.004), and it decreased significantly after ingestion of the V-meal in healthy controls (p < 0.001; Group x Meal x Time: F = ","['men with type 2 diabetes, overweight/obese, and healthy men', 'participants with type 2 diabetes (T2D; n\xa0=\xa020), overweight/obese participants (O; n\xa0=\xa020), and healthy controls (H; n\xa0=\xa020', 'men with diabetes;\xa0-0.72']","['plant-based meal', 'energy- and macronutrient-matched conventional meal', 'energy- and macronutrient-matched meals: a vegan (V-meal) and a conventional meat (M-meal']","['brain activity, gastrointestinal hormones, and satiety', 'visual analogue scale; and plasma concentrations of gut hormones', 'satiety', 'fasting plasma insulin', 'Thalamus perfusion', 'Brain perfusion', 'insulin secretion', 'higher postprandial GLP-1 secretion', 'Postprandial secretion of active GLP-1']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C4517475', 'cui_str': '0.72'}]","[{'cui': 'C0032098', 'cui_str': 'Kingdom Viridiplantae'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0344353', 'cui_str': 'Vegan'}, {'cui': 'C0025017', 'cui_str': 'Meat'}]","[{'cui': 'C0443158', 'cui_str': 'Brain activity'}, {'cui': 'C0017182', 'cui_str': 'Gastrointestinal hormone'}, {'cui': 'C0036239', 'cui_str': 'Satiety'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0857690', 'cui_str': 'Plasma insulin'}, {'cui': 'C0039729', 'cui_str': 'Thalamic structure'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C1256369', 'cui_str': 'Insulin Secretion'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0205177', 'cui_str': 'Active'}]",,0.0847429,"Thalamus perfusion decreased significantly after ingestion of the M-meal in men with T2D (p = 0.04) and overweight/obese men (p = 0.004), and it decreased significantly after ingestion of the V-meal in healthy controls (p < 0.001; Group x Meal x Time: F = ","[{'ForeName': 'Hana', 'Initials': 'H', 'LastName': 'Kahleova', 'Affiliation': 'Institute for Clinical and Experimental Medicine, Prague, Czech Republic; Physicians Committee for Responsible Medicine, Washington, DC, USA. Electronic address: hkahleova@pcrm.org.'}, {'ForeName': 'Jaroslav', 'Initials': 'J', 'LastName': 'Tintera', 'Affiliation': 'Institute for Clinical and Experimental Medicine, Prague, Czech Republic.'}, {'ForeName': 'Lenka', 'Initials': 'L', 'LastName': 'Thieme', 'Affiliation': 'Institute for Clinical and Experimental Medicine, Prague, Czech Republic.'}, {'ForeName': 'Jiri', 'Initials': 'J', 'LastName': 'Veleba', 'Affiliation': 'Institute for Clinical and Experimental Medicine, Prague, Czech Republic.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Klementova', 'Affiliation': 'Institute for Clinical and Experimental Medicine, Prague, Czech Republic.'}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Kudlackova', 'Affiliation': 'Institute for Clinical and Experimental Medicine, Prague, Czech Republic.'}, {'ForeName': 'Hana', 'Initials': 'H', 'LastName': 'Malinska', 'Affiliation': 'Institute for Clinical and Experimental Medicine, Prague, Czech Republic.'}, {'ForeName': 'Olena', 'Initials': 'O', 'LastName': 'Oliyarnyk', 'Affiliation': 'Institute for Clinical and Experimental Medicine, Prague, Czech Republic.'}, {'ForeName': 'Irena', 'Initials': 'I', 'LastName': 'Markova', 'Affiliation': 'Institute for Clinical and Experimental Medicine, Prague, Czech Republic.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Haluzik', 'Affiliation': 'Institute for Clinical and Experimental Medicine, Prague, Czech Republic.'}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Pavlovicova', 'Affiliation': 'Institute for Clinical and Experimental Medicine, Prague, Czech Republic.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Hill', 'Affiliation': 'Institute of Endocrinology, Prague, Czech Republic.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Tura', 'Affiliation': 'Metabolic Unit, CNR Institute of Neuroscience, Padua, Italy.'}, {'ForeName': 'Terezie', 'Initials': 'T', 'LastName': 'Pelikanova', 'Affiliation': 'Institute for Clinical and Experimental Medicine, Prague, Czech Republic.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2020.10.005']
1760,33081983,Effect of nutritional support in patients with lower respiratory tract infection: Secondary analysis of a randomized clinical trial.,"BACKGROUND


In polymorbid patients with bronchopulmonary infection, malnutrition is an independent risk factor for mortality. There is a lack of interventional data investigating whether providing nutritional support during the hospital stay in patients at risk for malnutrition presenting with lower respiratory tract infection lowers mortality.
METHODS


For this secondary analysis of a randomized clinical trial (EFFORT), we analyzed data of a subgroup of patients with confirmed lower respiratory tract infection from an initial cohort of 2028 patients. Patients at nutritional risk (Nutritional Risk Screening [NRS] score ≥3 points) were randomized to receive protocol-guided individualized nutritional support to reach protein and energy goals (intervention group) or standard hospital food (control group). The primary endpoint of this analysis was all-cause 30-day mortality.
RESULTS


We included 378 of 2028 EFFORT patients (mean age 74.4 years, 24% with COPD) into this analysis. Compared to usual care hospital nutrition, individualized nutritional support to reach caloric and protein goals showed a similar beneficial effect of on the risk of mortality in the subgroup of respiratory tract infection patients as compared to the main EFFORT trial (odds ratio 0.47 [95%CI 0.17 to 1.27, p = 0.136] vs 0.65 [95%CI 0.47 to 0.91, p = 0.011]) with no evidence of a subgroup effect (p for interaction 0.859). Effects were also similar among different subgroups based on etiology and type of respiratory tract infection and for other secondary endpoints.
CONCLUSION


This subgroup analysis from a large nutrition support trial suggests that patients at nutritional risk as assessed by NRS 2002 presenting with bronchopulmonary infection to the hospital likely have a mortality benefit from individualized inhospital nutritional support. The small sample size and limited statistical power calls for larger nutritional studies focusing on this highly vulnerable patient population.
CLINICAL TRIAL REGISTRATION


Registered under ClinicalTrials.gov Identifier no. NCT02517476.",2020,p = 0.011]) with no evidence of a subgroup effect (p for interaction 0.859).,"['Patients at nutritional risk (Nutritional Risk Screening [NRS] score ≥3 points', '378 of 2028 EFFORT patients (mean age 74.4 years, 24% with COPD) into this analysis', 'patients with confirmed lower respiratory tract infection from an initial cohort of 2028 patients', 'patients with lower respiratory tract infection', 'patients at risk for malnutrition presenting with lower respiratory tract infection lowers mortality']","['protocol-guided individualized nutritional support to reach protein and energy goals (intervention group) or standard hospital food (control group', 'nutritional support']","['etiology and type of respiratory tract infection', 'cause 30-day mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1268620', 'cui_str': 'At risk for nutritional problem'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0149725', 'cui_str': 'Lower respiratory tract infection'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0184549', 'cui_str': 'At risk for imbalanced nutrition, less than body requirements'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]","[{'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0242739', 'cui_str': 'Nutritional support'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0035243', 'cui_str': 'Respiratory tract infection'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",2028.0,0.157558,p = 0.011]) with no evidence of a subgroup effect (p for interaction 0.859).,"[{'ForeName': 'Annic', 'Initials': 'A', 'LastName': 'Baumgartner', 'Affiliation': 'Medical University Department, Division of General Internal and Emergency Medicine, Kantonsspital Aarau, Aarau, Switzerland; Medical Faculty of the University of Basel, Switzerland.'}, {'ForeName': 'Flavia', 'Initials': 'F', 'LastName': 'Hasenboehler', 'Affiliation': 'Medical University Department, Division of General Internal and Emergency Medicine, Kantonsspital Aarau, Aarau, Switzerland; Medical Faculty of the University of Basel, Switzerland.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Cantone', 'Affiliation': 'Medical University Department, Division of General Internal and Emergency Medicine, Kantonsspital Aarau, Aarau, Switzerland; Medical Faculty of the University of Basel, Switzerland.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Hersberger', 'Affiliation': 'Medical University Department, Division of General Internal and Emergency Medicine, Kantonsspital Aarau, Aarau, Switzerland; Medical Faculty of the University of Basel, Switzerland.'}, {'ForeName': 'Annika', 'Initials': 'A', 'LastName': 'Bargetzi', 'Affiliation': 'Medical University Department, Division of General Internal and Emergency Medicine, Kantonsspital Aarau, Aarau, Switzerland; Medical Faculty of the University of Basel, Switzerland.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Bargetzi', 'Affiliation': 'Medical University Department, Division of General Internal and Emergency Medicine, Kantonsspital Aarau, Aarau, Switzerland; Medical Faculty of the University of Basel, Switzerland.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Kaegi-Braun', 'Affiliation': 'Medical University Department, Division of General Internal and Emergency Medicine, Kantonsspital Aarau, Aarau, Switzerland.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Tribolet', 'Affiliation': 'Internal Medicine, Spital Lachen, Switzerland; Department of Health Professions, Bern University of Applied Sciences, Bern, Switzerland.'}, {'ForeName': 'Filomena', 'Initials': 'F', 'LastName': 'Gomes', 'Affiliation': 'Medical University Department, Division of General Internal and Emergency Medicine, Kantonsspital Aarau, Aarau, Switzerland; The New York Academy of Sciences, New York City, NY, USA.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Hoess', 'Affiliation': 'Internal Medicine, Kantonsspital Muensterlingen, Switzerland.'}, {'ForeName': 'Vojtech', 'Initials': 'V', 'LastName': 'Pavlicek', 'Affiliation': 'Internal Medicine, Kantonsspital Muensterlingen, Switzerland.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Bilz', 'Affiliation': 'Internal Medicine & Endocrinology/Diabetes, Kantonsspital St.Gallen, Switzerland.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Sigrist', 'Affiliation': 'Internal Medicine & Endocrinology/Diabetes, Kantonsspital St.Gallen, Switzerland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Brändle', 'Affiliation': 'Internal Medicine & Endocrinology/Diabetes, Kantonsspital St.Gallen, Switzerland.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Henzen', 'Affiliation': 'Internal Medicine, Kantonsspital Luzern, Switzerland.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Thomann', 'Affiliation': 'Department of Internal Medicine, Buergerspital Solothurn, Switzerland.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Rutishauser', 'Affiliation': 'Internal Medicine, Kantonsspital Baselland, Switzerland.'}, {'ForeName': 'Drahomir', 'Initials': 'D', 'LastName': 'Aujesky', 'Affiliation': 'Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Switzerland.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Rodondi', 'Affiliation': 'Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Switzerland; Institute of Primary Health Care (BIHAM), University of Bern, Switzerland.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Donzé', 'Affiliation': ""Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Switzerland; Division of General Internal Medicine, Brigham and Women's Hospital, Boston, MA, USA; Department of Medicine, Neuchâtel Hospital Network, Neuchâtel, Switzerland.""}, {'ForeName': 'Zeno', 'Initials': 'Z', 'LastName': 'Stanga', 'Affiliation': 'Division of Diabetology, Endocrinology, Nutritional Medicine & Metabolism, Inselspital, Bern University Hospital, University of Bern, Switzerland.'}, {'ForeName': 'Beat', 'Initials': 'B', 'LastName': 'Mueller', 'Affiliation': 'Medical University Department, Division of General Internal and Emergency Medicine, Kantonsspital Aarau, Aarau, Switzerland; Medical Faculty of the University of Basel, Switzerland.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Schuetz', 'Affiliation': 'Medical University Department, Division of General Internal and Emergency Medicine, Kantonsspital Aarau, Aarau, Switzerland; Medical Faculty of the University of Basel, Switzerland. Electronic address: schuetzph@gmail.com.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2020.10.009']
1761,33082016,Mood and cognition after administration of low LSD doses in healthy volunteers: A placebo controlled dose-effect finding study.,"There is a popular interest in microdosing with psychedelics such as LSD. This practice of using one-tenth of a full psychedelic dose according to a specific dosing schedule, anecdotally enhances mood and performance. Nonetheless, controlled research on the efficacy of microdosing is scarce. The main objective of the present dose-finding study was to determine the minimal dose of LSD needed to affect mood and cognition. A placebo-controlled within-subject study including 24 healthy participants, was conducted to assess the acute effects of three LSD doses (5, 10, and 20 mcg) on measures of cognition, mood, and subjective experience, up until 6 h after administration. Cognition and subjective experience were assessed using the Psychomotor Vigilance Task, Digit Symbol Substitution Test, Cognitive Control Task, Profile of Mood States, and 5-Dimensional Altered States of Consciousness rating scale. LSD showed positive effects in the majority of observations by increasing positive mood (20 mcg), friendliness (5, 20 mcg), arousal (5 mcg), and decreasing attentional lapses (5, 20 mcg). Negative effects manifested as an increase in confusion (20 mcg) and anxiety (5, 20 mcg). Psychedelic-induced changes in waking consciousness were also present (10, 20 mcg). Overall, the present study demonstrated selective, beneficial effects of low doses of LSD on mood and cognition in the majority of observations. The minimal LSD dose at which subjective and performance effects are notable is 5 mcg and the most apparent effects were visible after 20 mcg.",2020,"LSD showed positive effects in the majority of observations by increasing positive mood (20 mcg), friendliness (5, 20 mcg), arousal (5 mcg), and decreasing attentional lapses (5, 20 mcg).","['healthy volunteers', '24 healthy participants']","['low LSD', 'placebo', 'LSD']","['attentional lapses', 'Cognition and subjective experience', 'Psychomotor Vigilance Task, Digit Symbol Substitution Test, Cognitive Control Task, Profile of Mood States, and 5-Dimensional Altered States of Consciousness rating scale', 'waking consciousness', 'confusion (20 mcg) and anxiety', 'measures of cognition, mood, and subjective experience', 'Mood and cognition']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0024334', 'cui_str': 'Lysergic acid diethylamide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0043012', 'cui_str': 'Wakefulness'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0451394', 'cui_str': 'Profile of mood states'}, {'cui': 'C0150450', 'cui_str': 'Altered state of consciousness'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0009791', 'cui_str': 'Consciousness related finding'}, {'cui': 'C0009676', 'cui_str': 'Confusional state'}, {'cui': 'C0439211', 'cui_str': 'mcg'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0026516', 'cui_str': 'Mood'}]",24.0,0.0446701,"LSD showed positive effects in the majority of observations by increasing positive mood (20 mcg), friendliness (5, 20 mcg), arousal (5 mcg), and decreasing attentional lapses (5, 20 mcg).","[{'ForeName': 'Nadia R P W', 'Initials': 'NRPW', 'LastName': 'Hutten', 'Affiliation': 'Department of Neuropsychology & Psychopharmacology, Faculty of Psychology & Neuroscience, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Natasha L', 'Initials': 'NL', 'LastName': 'Mason', 'Affiliation': 'Department of Neuropsychology & Psychopharmacology, Faculty of Psychology & Neuroscience, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Patrick C', 'Initials': 'PC', 'LastName': 'Dolder', 'Affiliation': 'Department of Neuropsychology & Psychopharmacology, Faculty of Psychology & Neuroscience, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Eef L', 'Initials': 'EL', 'LastName': 'Theunissen', 'Affiliation': 'Department of Neuropsychology & Psychopharmacology, Faculty of Psychology & Neuroscience, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Friederike', 'Initials': 'F', 'LastName': 'Holze', 'Affiliation': 'Division of Clinical Pharmacology and Toxicology, Department of Biomedicine and Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Matthias E', 'Initials': 'ME', 'LastName': 'Liechti', 'Affiliation': 'Division of Clinical Pharmacology and Toxicology, Department of Biomedicine and Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Feilding', 'Affiliation': 'The Beckley Foundation, Beckley Park, Oxford, UK.'}, {'ForeName': 'Johannes G', 'Initials': 'JG', 'LastName': 'Ramaekers', 'Affiliation': 'Department of Neuropsychology & Psychopharmacology, Faculty of Psychology & Neuroscience, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Kim P C', 'Initials': 'KPC', 'LastName': 'Kuypers', 'Affiliation': 'Department of Neuropsychology & Psychopharmacology, Faculty of Psychology & Neuroscience, Maastricht University, Maastricht, the Netherlands.'}]",European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology,['10.1016/j.euroneuro.2020.10.002']
1762,33082187,Effects of external inspections on sepsis detection and treatment: a stepped-wedge study with cluster-level randomisation.,"OBJECTIVE


To evaluate the effects of external inspections on (1) hospital emergency departments' clinical processes for detecting and treating sepsis and (2) length of hospital stay and 30-day mortality.
DESIGN


Incomplete cluster-randomised stepped-wedge design using data from patient records and patient registries. We compared care processes and patient outcomes before and after the intervention using regression analysis.
SETTING


Nationwide inspections of sepsis care in emergency departments in Norwegian hospitals.
PARTICIPANTS


7407 patients presenting to hospital emergency departments with sepsis.
INTERVENTION


External inspections of sepsis detection and treatment led by a public supervisory institution.
MAIN OUTCOME MEASURES


Process measures for sepsis diagnostics and treatment, length of hospital stay and 30-day all-cause mortality.
RESULTS


After the inspections, there were significant improvements in the proportions of patients examined by a physician within the time frame set in triage (OR 1.28, 95% CI 1.07 to 1.53), undergoing a complete set of vital measurements within 1 hour (OR 1.78, 95% CI 1.10 to 2.87), having lactate measured within 1 hour (OR 2.75, 95% CI 1.83 to 4.15), having an adequate observation regimen (OR 2.20, 95% CI 1.51 to 3.20) and receiving antibiotics within 1 hour (OR 2.16, 95% CI 1.83 to 2.55). There was also significant reduction in mortality and length of stay, but these findings were no longer significant when controlling for time.
CONCLUSIONS


External inspections were associated with improvement of sepsis detection and treatment. These findings suggest that policy-makers and regulatory agencies should prioritise assessing the effects of their inspections and pay attention to the mechanisms by which the inspections might contribute to improve care for patients.
TRIAL REGISTRATION


NCT02747121.",2020,"There was also significant reduction in mortality and length of stay, but these findings were no longer significant when controlling for time.
","['Nationwide inspections of sepsis care in emergency departments in Norwegian hospitals', '7407 patients presenting to hospital emergency departments with sepsis']",['external inspections'],"['having lactate', 'mortality and length of stay', 'sepsis diagnostics and treatment, length of hospital stay and 30-day all-cause mortality', 'receiving antibiotics', 'hospital stay and 30-day mortality']","[{'cui': 'C0199219', 'cui_str': 'Inspection'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0028424', 'cui_str': 'Norwegian language'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}]","[{'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0199219', 'cui_str': 'Inspection'}]","[{'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",7407.0,0.101613,"There was also significant reduction in mortality and length of stay, but these findings were no longer significant when controlling for time.
","[{'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Husabø', 'Affiliation': 'Department of Social Science, Western Norway University of Applied Sciences, Sogndal, Norway.'}, {'ForeName': 'Roy Miodini', 'Initials': 'RM', 'LastName': 'Nilsen', 'Affiliation': 'Department of Health and Functioning, Western Norway University of Applied Sciences, Bergen, Norway.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Solligård', 'Affiliation': 'Clinic of Anesthesia and Intensive Care, St. Olavs Hospital University Hospital in Trondheim, Trondheim, Norway.'}, {'ForeName': 'Hans Kristian', 'Initials': 'HK', 'LastName': 'Flaatten', 'Affiliation': 'Department of Clinical Medicine, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Kieran', 'Initials': 'K', 'LastName': 'Walshe', 'Affiliation': 'Alliance Manchester Business School, The University of Manchester, Manchester, UK.'}, {'ForeName': 'Jan C', 'Initials': 'JC', 'LastName': 'Frich', 'Affiliation': 'Institute of Health and Society, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Gunnar Tschudi', 'Initials': 'GT', 'LastName': 'Bondevik', 'Affiliation': 'Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Geir Sverre', 'Initials': 'GS', 'LastName': 'Braut', 'Affiliation': 'Department of Research, Stavanger University Hospital, Stavanger, Norway.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Helgeland', 'Affiliation': 'Norwegian Institute of Public Health, Oslo, Norway.'}, {'ForeName': 'Stig', 'Initials': 'S', 'LastName': 'Harthug', 'Affiliation': 'Department of Research and Development, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Einar', 'Initials': 'E', 'LastName': 'Hovlid', 'Affiliation': 'Department of Social Science, Western Norway University of Applied Sciences, Sogndal, Norway einar.hovlid@hvl.no.'}]",BMJ open,['10.1136/bmjopen-2020-037715']
1763,33082191,(Rad 8)Caffeine prophylaxis to improve intermittent hypoxaemia in infants born late preterm: a randomised controlled dosage trial (Latte Dosage Trial).,"INTRODUCTION


Infants born late preterm (34+0 to 36+6 weeks' gestational age) have frequent episodes of intermittent hypoxaemia compared with term infants. Caffeine citrate reduces apnoea and intermittent hypoxaemia and improves long-term neurodevelopmental outcomes in infants born very preterm and may have similar effects in late preterm infants. Clearance of caffeine citrate increases with gestational age and late preterm infants are likely to need a higher dose than very preterm infants. Our aim is to determine the most effective and best-tolerated dose of caffeine citrate to reduce transient intermittent hypoxaemia events in late preterm infants.
METHODS AND ANALYSIS


A phase IIB, double-blind, five-arm, parallel, randomised controlled trial to compare the effect of four doses of oral caffeine citrate versus placebo on the frequency of intermittent hypoxaemia. Late preterm infants will be enrolled within 72 hours of birth and randomised to receive 5, 10, 15 or 20 mg/kg/day caffeine citrate or matching placebo daily until term corrected age. The frequency of intermittent hypoxaemia (events/hour where oxygen saturation concentration is ≥10% below baseline for ≤2 min) will be assessed with overnight oximetry at baseline, 2 weeks after randomisation (primary outcome) and at term corrected age. Growth will be measured at these timepoints, and effects on feeding and sleeping will be assessed by parental report. Data will be analysed using generalised linear mixed models.
ETHICS AND DISSEMINATION


This trial has been approved by the Health and Disability Ethics Committees of New Zealand (reference 18/NTA/129) and the local institutional research review committees. Findings will be disseminated to peer-reviewed journals to clinicians and researchers at local and international conferences and to the public. The findings of the trial will inform the design of a large multicentre trial of prophylactic caffeine in late preterm infants, by indicating the most appropriate dose to use and providing information on feasibility.
TRIAL REGISTRATION NUMBER


ACTRN12618001745235; Pre-results.",2020,Caffeine citrate reduces apnoea and intermittent hypoxaemia and improves long-term neurodevelopmental outcomes in infants born very preterm and may have similar effects in late preterm infants.,"['Late preterm infants', 'late preterm infants', 'infants born late preterm', 'infants born very preterm']","['8)Caffeine prophylaxis', 'Caffeine citrate', 'caffeine citrate or matching placebo', 'oral caffeine citrate versus placebo', 'caffeine citrate', 'prophylactic caffeine']","['intermittent hypoxaemia', 'frequency of intermittent hypoxaemia (events/hour where oxygen saturation concentration', 'apnoea and intermittent hypoxaemia and improves long-term neurodevelopmental outcomes', 'frequency of intermittent hypoxaemia', 'transient intermittent hypoxaemia events']","[{'cui': 'C3898619', 'cui_str': 'Late preterm infant'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0205087', 'cui_str': 'Late'}]","[{'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0054436', 'cui_str': 'Caffeine citrate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0040704', 'cui_str': 'Transients'}]",,0.496593,Caffeine citrate reduces apnoea and intermittent hypoxaemia and improves long-term neurodevelopmental outcomes in infants born very preterm and may have similar effects in late preterm infants.,"[{'ForeName': 'Elizabeth Anne', 'Initials': 'EA', 'LastName': 'Oliphant', 'Affiliation': 'Department of Paediatrics: Child and Youth Health, The University of Auckland, Auckland, New Zealand e.oliphant@auckland.ac.nz.'}, {'ForeName': 'Christopher J D', 'Initials': 'CJD', 'LastName': 'McKinlay', 'Affiliation': 'Liggins Institute, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'McNamara', 'Affiliation': ""Paediatrics Respiratory Services, Starship Children's Health, Auckland District Health Board, Auckland, New Zealand.""}, {'ForeName': 'Jane Marie', 'Initials': 'JM', 'LastName': 'Alsweiler', 'Affiliation': 'Department of Paediatrics: Child and Youth Health, The University of Auckland, Auckland, New Zealand.'}]",BMJ open,['10.1136/bmjopen-2020-038271']
1764,33082194,"Natalizumab versus fingolimod for patients with active relapsing-remitting multiple sclerosis: results from REVEAL, a prospective, randomised head-to-head study.","OBJECTIVE


To directly compare the efficacy of natalizumab and fingolimod in patients with active relapsing-remitting multiple sclerosis.
METHODS


This phase 4, randomised, rater- and sponsor-blinded, prospective, parallel-group, clinic-based head-to-head study was conducted at 43 sites in nine countries. Patients were randomised (1:1) to intravenous natalizumab 300 mg every 4 weeks or oral fingolimod 0.5 mg once daily for ≤52 weeks. Enrolment-related early study termination precluded assessment of the primary endpoint (evolution of new on-treatment gadolinium-enhancing (Gd+) lesions to persistent black holes). Unplanned exploratory analyses of secondary endpoints evaluated the effects of treatment on the development of new T1 Gd+ lesions and new/newly enlarging T2 lesions, lesion volumes and relapse outcomes.
RESULTS


The intent-to-treat population comprised 108 patients (natalizumab, n=54; fingolimod, n=54); 63 completed ≥24 weeks of treatment. Due to the limited numbers of events and patients at risk, MRI and relapse outcomes were reported over up to 24 and 36 weeks, respectively. The mean number of new T1 Gd+ lesions was numerically lower with natalizumab than with fingolimod by 4 weeks; accumulation rates were 0.02 and 0.09 per week, respectively, over 24 weeks (p=0.004). The cumulative probability of developing ≥1 lesion at 24 weeks was 40.7% with natalizumab versus 58.0% with fingolimod (HR=0.60; 95% CI 0.31-1.16; p=0.126); the corresponding probabilities for ≥2 lesions were 11.5% vs 48.5% (HR=0.25; 95% CI 0.09-0.68; p=0.007). No significant between-group differences were observed for the other MRI outcomes at 24 weeks. The cumulative probability of relapse over follow-up was 1.9% with natalizumab versus 22.3% with fingolimod (HR=0.08; 95% CI 0.01-0.64; p=0.017). Adverse events were consistent with known safety profiles.
CONCLUSIONS


These results suggest that natalizumab is more efficacious than fingolimod in reducing multiple sclerosis relapses and T1 Gd+ lesion accumulation in patients with active disease.
TRIAL REGISTRATION NUMBERS


NCT02342704; EUCTR2013-004622-29-IT; Post-results.",2020,"The mean number of new T1 Gd+ lesions was numerically lower with natalizumab than with fingolimod by 4 weeks; accumulation rates were 0.02 and 0.09 per week, respectively, over 24 weeks (p=0.004).","['patients with active disease', 'patients with active relapsing-remitting multiple sclerosis', '108 patients (natalizumab, n=54; fingolimod, n=54); 63 completed ≥24 weeks of treatment']","['natalizumab', 'Natalizumab versus fingolimod', 'intravenous natalizumab 300\u2009mg every 4 weeks or oral fingolimod 0.5\u2009mg once daily for ≤52 weeks', 'natalizumab and fingolimod']","['development of new T1 Gd+ lesions\u2009and new/newly enlarging T2 lesions, lesion volumes and relapse outcomes', 'multiple sclerosis relapses and T1 Gd+ lesion accumulation', 'accumulation rates', 'Adverse events', 'cumulative probability of developing ≥1 lesion', 'cumulative probability of relapse', 'mean number of new T1 Gd+ lesions', 'MRI outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0751967', 'cui_str': 'Relapsing remitting multiple sclerosis'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C1172734', 'cui_str': 'natalizumab'}, {'cui': 'C1699926', 'cui_str': 'fingolimod'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C1172734', 'cui_str': 'natalizumab'}, {'cui': 'C1699926', 'cui_str': 'fingolimod'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C1275555', 'cui_str': 'Every four weeks'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C2938759', 'cui_str': 'fingolimod 0.5 MG'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0442800', 'cui_str': 'Enlarged'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0856120', 'cui_str': 'Multiple sclerosis relapse'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]",,0.201654,"The mean number of new T1 Gd+ lesions was numerically lower with natalizumab than with fingolimod by 4 weeks; accumulation rates were 0.02 and 0.09 per week, respectively, over 24 weeks (p=0.004).","[{'ForeName': 'Helmut', 'Initials': 'H', 'LastName': 'Butzkueven', 'Affiliation': 'Department of Neuroscience, Central Clinical School, Alfred Campus, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Licata', 'Affiliation': 'Biogen, Cambridge, Massachusetts, USA stephanie.licata@biogen.com.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Jeffery', 'Affiliation': 'Piedmont HealthCare, Mooresville, North Carolina, USA.'}, {'ForeName': 'Douglas L', 'Initials': 'DL', 'LastName': 'Arnold', 'Affiliation': 'Montreal Neurological Institute and Hospital, Montreal, Québec, Canada.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Filippi', 'Affiliation': 'Neuroimaging Research Unit, Institute of Experimental Neurology, Division of Neuroscience, San Raffaele Scientific Institute, Vita-Salute San Raffaele University, Milan, Italy.'}, {'ForeName': 'Jeroen Jg', 'Initials': 'JJ', 'LastName': 'Geurts', 'Affiliation': 'Department of Anatomy and Neurosciences, Section of Clinical Neuroscience, VUmc MS Center Amsterdam, VU University Medical Centre Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Sourav', 'Initials': 'S', 'LastName': 'Santra', 'Affiliation': 'Biogen (at the time of these analyses), Cambridge, Massachusetts, USA.'}, {'ForeName': 'Nolan', 'Initials': 'N', 'LastName': 'Campbell', 'Affiliation': 'Biogen, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Pei-Ran', 'Initials': 'PR', 'LastName': 'Ho', 'Affiliation': 'Biogen (at the time of these analyses), Cambridge, Massachusetts, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2020-038861']
1765,33082202,Assessing 10-year safety of a single negative HPV test for cervical cancer screening: Evidence from FOCAL-DECADE cohort.,"BACKGROUND


Long-term safety of a single negative human papillomavirus (HPV) test for cervical cancer screening is unclear. The HPV FOr cerviCAL Cancer Trial (FOCAL) was a randomized trial comparing HPV testing to cytology. The FOCAL-DECADE cohort tracked women who received one HPV test during FOCAL, and were HPV negative, for up to 10 years to identify cervical intraepithelial neoplasia grade 2 or worse (CIN2+) and grade 3 or worse (CIN3+) detected through a provincial screening program.
METHODS


FOCAL participants who received one HPV test and were negative and had at least one post-FOCAL cervix screen were included (N = 5537). We constructed cumulative incidence curves of CIN2+/CIN3+ detection, analyzed cumulative risk of detection at intervals post-HPV test, calculated average incidence rates for detection, and compared hazard across ages.
RESULTS


Ten years after one negative HPV test, the probability of CIN2+ detection was lower than 1%, with most lesions detected seven years or later. Average incidence rates of CIN2+/CIN3+ lesions over follow-up were 0.50 (95% CI: 0.31, 0.78) and 0.18 (0.07, 0.36) per 1000 person-years, respectively. Hazards were higher for younger ages (non-significant trend).
CONCLUSIONS


Among women with a single negative HPV test, long-term risk of CIN2+ detection was low, particularly through seven years of follow-up; thus, one negative HPV test appears to confer long-term protection from precancerous lesions. Even 10-year risk is sufficiently low to support extended testing intervals in average-risk populations.
IMPACT


Our findings support the safety of screening policies using HPV testing alone at five-year or longer intervals.",2020,"Average incidence rates of CIN2+/CIN3+ lesions over follow-up were 0.50 (95% CI: 0.31, 0.78) and 0.18 (0.07, 0.36) per 1000 person-years, respectively.","['cervical cancer screening', 'FOCAL participants who received one HPV test and were negative and had at least one post-FOCAL cervix screen were included (N = 5537']","['single negative HPV test', 'single negative human papillomavirus (HPV) test']","['probability of CIN2+ detection', 'Average incidence rates of CIN2+/CIN3+ lesions', 'cervical intraepithelial neoplasia grade 2 or worse (CIN2+) and grade 3 or worse (CIN3']","[{'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0007874', 'cui_str': 'Cervix uteri structure'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0349459', 'cui_str': 'Cervical intraepithelial neoplasia grade 2'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0851140', 'cui_str': 'Carcinoma in situ of uterine cervix'}]",5537.0,0.184968,"Average incidence rates of CIN2+/CIN3+ lesions over follow-up were 0.50 (95% CI: 0.31, 0.78) and 0.18 (0.07, 0.36) per 1000 person-years, respectively.","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Gottschlich', 'Affiliation': 'Faculty of Medicine, University of British Columbia anna.gottschlich@cw.bc.ca.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'van Niekerk', 'Affiliation': 'BC Cancer Agency.'}, {'ForeName': 'Laurie W', 'Initials': 'LW', 'LastName': 'Smith', 'Affiliation': 'Cancer Control Research, BC Cancer Agency.'}, {'ForeName': 'Lovedeep', 'Initials': 'L', 'LastName': 'Gondara', 'Affiliation': 'BC Cancer Agency.'}, {'ForeName': 'Joy', 'Initials': 'J', 'LastName': 'Melinikow', 'Affiliation': 'Department of Family and Community Medicine, University of California, Davis.'}, {'ForeName': 'Darrel A', 'Initials': 'DA', 'LastName': 'Cook', 'Affiliation': 'Clinical Prevention Services, BC Centre for Disease Control.'}, {'ForeName': 'Marette', 'Initials': 'M', 'LastName': 'Lee', 'Affiliation': 'Cervical cancer screening program, BC Cancer Agency.'}, {'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Stuart', 'Affiliation': 'Faculty of Medicine, University of British Columbia.'}, {'ForeName': 'Ruth E', 'Initials': 'RE', 'LastName': 'Martin', 'Affiliation': 'Faculty of Medicine, University of British Columbia.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Peacock', 'Affiliation': 'Canadian Centre for Applied Research in Cancer Control, British Columbia Cancer Agency.'}, {'ForeName': 'Eduardo L', 'Initials': 'EL', 'LastName': 'Franco', 'Affiliation': 'Department of Oncology, McGill University.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Coldman', 'Affiliation': 'BC Cancer Agency.'}, {'ForeName': 'Mel', 'Initials': 'M', 'LastName': 'Krajden', 'Affiliation': 'Clinical Prevention Services, BC Centre for Disease Control.'}, {'ForeName': 'Gina', 'Initials': 'G', 'LastName': 'Ogilvie', 'Affiliation': 'School of Population and Public Health, University of British Columbia.'}]","Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology",['10.1158/1055-9965.EPI-20-1177']
1766,33082286,"Transmuscular quadratus lumborum block for total laparoscopic hysterectomy: a double-blind, randomized, placebo-controlled trial.","BACKGROUND


The population of patients scheduled for total laparoscopic hysterectomy at our surgical center is heterogeneous concerning a multitude of demographic variables such as age, collateral surgery and malign or benign pathogenesis. A common denominator is moderate to severe postoperative pain and a substantial opioid consumption. A recent procedure specific postoperative pain management (PROSPECT) review found no gain from the regional techniques included. The transmuscular quadratus lumborum (TQL) block has shown promising results in recent trials for other types of surgery. The aim of the current study was to investigate the analgesic efficacy of the ultrasound-guided TQL block for total laparoscopic hysterectomy.
METHODS


We enrolled 70 patients and randomly allocated participants to preoperative bilateral ultrasound-guided TQL block with either 60 mL 0.375% ropivacaine or 60 mL isotonic saline. Preoperatively, all patients received the TQL block (active or placebo) as well as a standardized multimodal analgesic regimen consisting of oral paracetamol, ibuprofen and dexamethasone. Intraoperatively, intravenous sufentanil 0.2 µg/kg was administered 30 min prior to emergence.
PRIMARY OUTCOME


Opioid consumption during the first 12 postoperative hours.
SECONDARY OUTCOMES


Pain scores, times to first opioid demand and first ambulation, nausea and vomiting, and total opioid consumption during the first 24 postoperative hours.
RESULTS


No significant intergroup differences were observed for any outcome. Mean (SD) oral morphine equivalent consumption the first 12 postoperative hours was 58.4 mg (48.3) vs 62.9 mg (48.5), p=0.70, for group ropivacaine versus group saline.
CONCLUSION


Preoperative bilateral ultrasound-guided TQL block did not reduce opioid consumption after total laparoscopic hysterectomy.
TRIAL REGISTRATION NUMBERS


NCT03650998, EudraCT (2017-004593-34).",2020,No significant intergroup differences were observed for any outcome.,['70 patients and randomly allocated participants to'],"['sufentanil', 'total laparoscopic hysterectomy', 'ropivacaine', 'paracetamol, ibuprofen and dexamethasone', 'ultrasound-guided TQL block', 'Preoperative bilateral ultrasound-guided TQL block', 'preoperative bilateral ultrasound-guided TQL block with either 60\u2009mL 0.375% ropivacaine or 60\u2009mL isotonic saline', 'placebo', 'TQL block (active or placebo', 'Transmuscular quadratus lumborum block']","['Opioid consumption during the first 12 postoperative hours', 'Pain scores, times to first opioid demand and first ambulation, nausea and vomiting, and total opioid consumption', 'Mean (SD) oral morphine equivalent consumption', 'opioid consumption', 'analgesic efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0404089', 'cui_str': 'Laparoscopic hysterectomy'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0224380', 'cui_str': 'Structure of quadratus lumborum muscle'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C4517455', 'cui_str': '0.375'}, {'cui': 'C0454287', 'cui_str': 'Isotonic exercise'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0360457', 'cui_str': 'Morphine-containing product in oral dose form'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",70.0,0.651425,No significant intergroup differences were observed for any outcome.,"[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hansen', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Zealand University Hospital, Roskilde, Denmark.'}, {'ForeName': 'Mette', 'Initials': 'M', 'LastName': 'Dam', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Zealand University Hospital, Roskilde, Denmark.'}, {'ForeName': 'Martin Vedel', 'Initials': 'MV', 'LastName': 'Nielsen', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Zealand University Hospital, Roskilde, Denmark.'}, {'ForeName': 'Katrine B', 'Initials': 'KB', 'LastName': 'Tanggaard', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Zealand University Hospital, Roskilde, Denmark.'}, {'ForeName': 'Troels Dirch', 'Initials': 'TD', 'LastName': 'Poulsen', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Zealand University Hospital, Roskilde, Denmark.'}, {'ForeName': 'Thomas Fichtner', 'Initials': 'TF', 'LastName': 'Bendtsen', 'Affiliation': 'Department of Anesthesiology, Aarhus Universitetshospital, Aarhus, Denmark.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Børglum', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Zealand University Hospital, Roskilde, Denmark jens.borglum@gmail.com.'}]",Regional anesthesia and pain medicine,['10.1136/rapm-2020-101931']
1767,33082342,A pragmatic randomized controlled trial reports lack of efficacy of hydroxychloroquine on coronavirus disease 2019 viral kinetics.,"Here, we randomized 53 patients hospitalized with coronavirus disease 2019 (COVID-19) to hydroxychloroquine therapy (at a dose of 400 mg twice daily for seven days) in addition to standard care or standard care alone (ClinicalTrials.gov Identifier, NCT04316377). All severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) positive patients 18 years of age or older were eligible for study inclusion if they had moderately severe COVID-19 at admission. Treatment with hydroxychloroquine did not result in a significantly greater rate of decline in SARS-CoV-2 oropharyngeal viral load compared to standard care alone during the first five days. Our results suggest no important antiviral effect of hydroxychloroquine in humans infected with SARS-CoV-2.",2020,Treatment with hydroxychloroquine did not result in a significantly greater rate of decline in SARS-CoV-2 oropharyngeal viral load compared to standard care alone during the first five days.,"['53 patients hospitalized with coronavirus disease 2019 (COVID-19) to', 'All severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2', 'coronavirus disease 2019 viral kinetics', 'positive patients 18 years of age or older were eligible for study inclusion if they had moderately severe COVID-19 at admission']","['hydroxychloroquine', 'hydroxychloroquine therapy (at a dose of 400\u2009mg twice daily for seven days) in addition to standard care or standard care alone']",['rate of decline in SARS-CoV-2 oropharyngeal viral load'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C5190549', 'cui_str': 'Hydroxychloroquine therapy'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}]",53.0,0.292815,Treatment with hydroxychloroquine did not result in a significantly greater rate of decline in SARS-CoV-2 oropharyngeal viral load compared to standard care alone during the first five days.,"[{'ForeName': 'Magnus Nakrem', 'Initials': 'MN', 'LastName': 'Lyngbakken', 'Affiliation': 'Division of Medicine, Akershus University Hospital, Lørenskog, Norway.'}, {'ForeName': 'Jan-Erik', 'Initials': 'JE', 'LastName': 'Berdal', 'Affiliation': 'Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Eskesen', 'Affiliation': 'Department of Infectious Diseases, Division of Medicine, Akershus University Hospital, Lørenskog, Norway.'}, {'ForeName': 'Dag', 'Initials': 'D', 'LastName': 'Kvale', 'Affiliation': 'Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Inge Christoffer', 'Initials': 'IC', 'LastName': 'Olsen', 'Affiliation': 'Department of Research Support for Clinical Trials, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Corina Silvia', 'Initials': 'CS', 'LastName': 'Rueegg', 'Affiliation': 'Department of Research Support for Clinical Trials, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Anbjørg', 'Initials': 'A', 'LastName': 'Rangberg', 'Affiliation': 'Center for Laboratory Medicine, Østfold Hospital Trust, Grålum, Norway.'}, {'ForeName': 'Christine Monceyron', 'Initials': 'CM', 'LastName': 'Jonassen', 'Affiliation': 'Center for Laboratory Medicine, Østfold Hospital Trust, Grålum, Norway.'}, {'ForeName': 'Torbjørn', 'Initials': 'T', 'LastName': 'Omland', 'Affiliation': 'Division of Medicine, Akershus University Hospital, Lørenskog, Norway.'}, {'ForeName': 'Helge', 'Initials': 'H', 'LastName': 'Røsjø', 'Affiliation': 'Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway. helge.rosjo@medisin.uio.no.'}, {'ForeName': 'Olav', 'Initials': 'O', 'LastName': 'Dalgard', 'Affiliation': 'Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway.'}]",Nature communications,['10.1038/s41467-020-19056-6']
1768,33082407,On the robustness of the hybrid qubit computational gates through simulated randomized benchmarking protocols.,"One of the main challenges in building a quantum processor is to characterize the environmental noise. Noise characterization can be achieved by exploiting different techniques, such as randomization where several sequences of random quantum gates are applied to the qubit under test to derive statistical characteristics about the affecting noises. A scalable and robust algorithm able to benchmark the full set of Clifford gates using randomization techniques is called randomized benchmarking. In this study, we simulated randomized benchmarking protocols in a semiconducting all-electrical three-electron double-quantum dot qubit, i.e. hybrid qubit, under different error models, that include quasi-static Gaussian and the more realistic 1/f noise model, for the input controls. The average error of specific quantum computational gates is extracted through interleaved randomized benchmarking obtained including Clifford gates between the gate of interest. It provides an estimate of the fidelity as well as theoretical bounds for the average error of the gate under test.",2020,A scalable and robust algorithm able to benchmark the full set of Clifford gates using randomization techniques is called randomized benchmarking.,[],[],[],[],[],[],,0.0409053,A scalable and robust algorithm able to benchmark the full set of Clifford gates using randomization techniques is called randomized benchmarking.,"[{'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Ferraro', 'Affiliation': 'CNR-IMM Agrate Unit, Via C. Olivetti 2, 20864, Agrate Brianza, MB, Italy. elena.ferraro@mdm.imm.cnr.it.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'De Michielis', 'Affiliation': 'CNR-IMM Agrate Unit, Via C. Olivetti 2, 20864, Agrate Brianza, MB, Italy. marco.demichielis@mdm.imm.cnr.it.'}]",Scientific reports,['10.1038/s41598-020-74817-z']
1769,33082512,"A multicenter prospective, randomized, placebo-controlled phase II/III trial for preemptive acute graft-versus-host disease therapy.","Acute graft-versus-host disease (aGvHD) contributes to about 50% of transplant-related mortality (non-relapse mortality) after allogeneic hematopoietic stem cell transplantation (HSCT). Here the predictive value of a urinary proteomic profile (aGvHD_MS17) was tested together with preemptive prednisolone therapy. Two-hundred and fifty-nine of 267 patients were eligible for analysis. Ninety-two patients were randomized upon aGvHD_MS17 classification factor above 0.1 to receive either prednisolone (2-2.5 mg/kg, N = 44) or placebo (N = 47; N = 1 randomization failure) for 5 days followed by tapering. The remaining 167 patients formed the observation group. The primary endpoint of the randomized trial was incidence of aGvHD grade II between randomization and day +100 post HSCT. Analysis of the short-term preemptive prednisolone therapy in the randomized patients showed no significant difference in incidence or severity of acute GvHD (HR: 1.69, 95% CI: 0.66-4.32, P = 0.27). Prednisolone as preemptive treatment did not lead to an increase in relapse (20.2% in the placebo and 14.0% in the prednisolone group (P = 0.46)). The frequency of adverse events was slightly higher in the placebo group (64.4% versus 50%, respectively). Taken together, the results of the Pre-GvHD trial demonstrated the feasibility and safety of preemptive prednisolone treatment in the randomized patients.",2020,"The frequency of adverse events was slightly higher in the placebo group (64.4% versus 50%, respectively).",['Two-hundred and fifty-nine of 267 patients were eligible for analysis'],"['Prednisolone', 'preemptive acute graft-versus-host disease therapy', 'allogeneic hematopoietic stem cell transplantation (HSCT', 'placebo', 'prednisolone']","['frequency of adverse events', 'incidence or severity of acute GvHD', 'relapse', 'feasibility and safety', 'incidence of aGvHD grade']","[{'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C4517672', 'cui_str': '267'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0856825', 'cui_str': 'Acute graft-versus-host disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0856825', 'cui_str': 'Acute graft-versus-host disease'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441800', 'cui_str': 'Grade'}]",267.0,0.326088,"The frequency of adverse events was slightly higher in the placebo group (64.4% versus 50%, respectively).","[{'ForeName': 'Eva M', 'Initials': 'EM', 'LastName': 'Weissinger', 'Affiliation': 'Department of Hematology, Hemostasis, Oncology and Stem Cell Transplantation, Hannover Medical School, Hannover, Germany. Mischak-weissinger.eva@mh-hannover.de.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Metzger', 'Affiliation': 'Mosaiques Diagnostics GmbH, Hannover, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schleuning', 'Affiliation': 'Deutsche Klinik fuer Diagnostik, Wiesbaden, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Schmid', 'Affiliation': 'Klinikum Augsburg, Augsburg, Germany.'}, {'ForeName': 'Diethelm', 'Initials': 'D', 'LastName': 'Messinger', 'Affiliation': 'Prometris, Mannheim, Germany.'}, {'ForeName': 'Gernot', 'Initials': 'G', 'LastName': 'Beutel', 'Affiliation': 'Department of Hematology, Hemostasis, Oncology and Stem Cell Transplantation, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Eva-Maria', 'Initials': 'EM', 'LastName': 'Wagner-Drouet', 'Affiliation': 'III. Department of Medicine-Hematology, Internal Oncology & Pneumology, Johannes Gutenberg-University Medical Center, Mainz, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Schetelig', 'Affiliation': 'Technical University Dresden, Dresden, Germany.'}, {'ForeName': 'Herrad', 'Initials': 'H', 'LastName': 'Baurmann', 'Affiliation': 'Helios Klinikum Berlin-Buch, Berlin, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Rank', 'Affiliation': 'Klinikum Augsburg, Augsburg, Germany.'}, {'ForeName': 'Friedrich', 'Initials': 'F', 'LastName': 'Stolzl', 'Affiliation': 'Technical University Dresden, Dresden, Germany.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Schäfer-Eckart', 'Affiliation': 'Klinikum Nürnberg, Paracelsus Medizinische Privatuniversität, Nuremberg, Germany.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Westphal', 'Affiliation': 'Klinikum Nürnberg, Paracelsus Medizinische Privatuniversität, Nuremberg, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Bethge', 'Affiliation': 'University of Tuebingen Medical Center, Tuebingen, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'von Harsdorf', 'Affiliation': 'Department of Internal Medicine III, University of Ulm, Ulm, Germany.'}, {'ForeName': 'Donald W', 'Initials': 'DW', 'LastName': 'Bunjes', 'Affiliation': 'Department of Internal Medicine III, University of Ulm, Ulm, Germany.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Heidenreich', 'Affiliation': 'Department of Hematology and Oncology, University Hospital Mannheim, Heidelberg University, Heidelberg, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Klein', 'Affiliation': 'Department of Hematology and Oncology, University Hospital Mannheim, Heidelberg University, Heidelberg, Germany.'}, {'ForeName': 'Ernst', 'Initials': 'E', 'LastName': 'Holler', 'Affiliation': 'Department of Internal Medicine III, University Hospital Regensburg, Regensburg, Germany.'}, {'ForeName': 'Hans H', 'Initials': 'HH', 'LastName': 'Kreipe', 'Affiliation': 'Institute of Pathology, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'Jonigk', 'Affiliation': 'Institute of Pathology, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Türüchanow', 'Affiliation': 'Department of Hematology, Hemostasis, Oncology and Stem Cell Transplantation, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Raad', 'Affiliation': 'Mosaiques Diagnostics GmbH, Hannover, Germany.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Papkalla', 'Affiliation': 'Hannover Clinical Trial Center (HCTC), Hannover Medical School, Hanover, Germany.'}, {'ForeName': 'Heiko', 'Initials': 'H', 'LastName': 'von der Leyen', 'Affiliation': 'Hannover Clinical Trial Center (HCTC), Hannover Medical School, Hanover, Germany.'}, {'ForeName': 'Lothar', 'Initials': 'L', 'LastName': 'Hambach', 'Affiliation': 'Department of Hematology, Hemostasis, Oncology and Stem Cell Transplantation, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Iyas', 'Initials': 'I', 'LastName': 'Hamwi', 'Affiliation': 'Department of Hematology, Hemostasis, Oncology and Stem Cell Transplantation, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Ehrlich', 'Affiliation': 'Department of Hematology, Hemostasis, Oncology and Stem Cell Transplantation, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Jurgen', 'Initials': 'J', 'LastName': 'Krauter', 'Affiliation': 'Department of Hematology, Hemostasis, Oncology and Stem Cell Transplantation, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Stadler', 'Affiliation': 'Department of Hematology, Hemostasis, Oncology and Stem Cell Transplantation, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Arnold', 'Initials': 'A', 'LastName': 'Ganser', 'Affiliation': 'Department of Hematology, Hemostasis, Oncology and Stem Cell Transplantation, Hannover Medical School, Hannover, Germany.'}]",Leukemia,['10.1038/s41375-020-01059-3']
1770,33082649,"Re: Bansal D, Nayak B, Singh P, Nayyar R, Ramachandran R, Kumar R,  et al.  Randomized controlled trial to compare outcomes with and without the enhanced recovery after surgery protocol in patients undergoing radical cystectomy. Indian J Urol 2020;36:95-100.",,2020,,['patients undergoing radical cystectomy'],[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0194401', 'cui_str': 'Complete cystectomy'}]",[],[],,0.138067,,"[{'ForeName': 'Ankit', 'Initials': 'A', 'LastName': 'Misra', 'Affiliation': 'Department of Urology, AIIMS, Bhubaneshwar, Odisha, India.'}, {'ForeName': 'Swarnendu', 'Initials': 'S', 'LastName': 'Mandal', 'Affiliation': 'Department of Urology, AIIMS, Bhubaneshwar, Odisha, India.'}, {'ForeName': 'Manoj K', 'Initials': 'MK', 'LastName': 'Das', 'Affiliation': 'Department of Urology, AIIMS, Bhubaneshwar, Odisha, India.'}, {'ForeName': 'Prasant', 'Initials': 'P', 'LastName': 'Nayak', 'Affiliation': 'Department of Urology, AIIMS, Bhubaneshwar, Odisha, India.'}]",Indian journal of urology : IJU : journal of the Urological Society of India,['10.4103/iju.IJU_174_20']
1771,33082650,"Author Reply Re: Bansal D, Nayak B, Singh P, Nayyar R, Ramachandran R, Kumar R, Seth A. Randomized controlled trial to compare outcomes with and without the enhanced recovery after surgery protocol in patients undergoing radical cystectomy. Indian J Urol 2020;36:95-100.",,2020,,['patients undergoing radical cystectomy'],[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0194401', 'cui_str': 'Complete cystectomy'}]",[],[],,0.143224,,"[{'ForeName': 'Devanshu', 'Initials': 'D', 'LastName': 'Bansal', 'Affiliation': 'Department of Urology, Uro-Oncology and Renal Transplant, Max Hospital, New Delhi, India.'}, {'ForeName': 'Brusabhanu', 'Initials': 'B', 'LastName': 'Nayak', 'Affiliation': 'Department of Urology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Prabhjot', 'Initials': 'P', 'LastName': 'Singh', 'Affiliation': 'Department of Urology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Rishi', 'Initials': 'R', 'LastName': 'Nayyar', 'Affiliation': 'Department of Urology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Rashmi', 'Initials': 'R', 'LastName': 'Ramachandran', 'Affiliation': 'Department of Anesthesiology, Pain Medicine and Critical Care, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Rajeev', 'Initials': 'R', 'LastName': 'Kumar', 'Affiliation': 'Department of Urology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Amlesh', 'Initials': 'A', 'LastName': 'Seth', 'Affiliation': 'Department of Urology, All India Institute of Medical Sciences, New Delhi, India.'}]",Indian journal of urology : IJU : journal of the Urological Society of India,['10.4103/iju.IJU_195_20']
1772,33082658,Effect of bromelain enzyme on the microleakage of composite resin restorations after external tooth bleaching: An  in vitro  study.,"Aims


The aim of this study is to evaluate  in vitro  the effect of application of bromelain enzyme on the microleakage of composite resin restorations after external tooth bleaching using spectrophotometric evaluation.
Subjects and Methods


Buccal Class V cavities were prepared on the surface of fifty intact premolars, which were randomly divided into five groups. All cavities were filled with composite resin. Group I: Teeth were not bleached but restored ( n  = 10). External bleaching with 35% hydrogen peroxide was carried out for the rest of the specimensGroup II: Cavities were restored immediately after bleaching ( n  = 10)Group III: Cavities were restored after a delay of 3 weeks ( n  = 10)Group IV: Cavities were treated with sodium ascorbate after bleaching and then restored ( n  = 10)Group V: Cavities were treated with bromelain enzyme solution after bleaching and then restored ( n  = 10). Microleakage was assessed by the dye extraction method using a spectrophotometer.
Statistical Analysis Used


The data were analyzed statistically by comparison of mean microleakage and post hoc test using SPSS 2.0 software.
Results


Group I displayed the least amount of microleakage, whereas Group II showed the greatest amount of microleakage ( P  < 0.05). Groups III, IV, and V showed a significantly lower amount of microleakage compared to Group II ( P  < 0.05). There was no statistically significant difference between Groups IV and V.
Conclusions


Microleakage increased significantly after external bleaching with 35% hydrogen peroxide, and decreased when the bleached teeth were treated with antioxidants. Ten percent bromelain enzyme was effective in decreasing microleakage; however, its efficacy was similar to 10% sodium ascorbate.",2019,"Groups III, IV, and V showed a significantly lower amount of microleakage compared to Group II ( P  < 0.05).","['Subjects and Methods\n\n\nBuccal Class V cavities were prepared on the surface of fifty intact premolars', 'composite resin restorations after external tooth bleaching']","['sodium ascorbate after bleaching and then restored ( n  = 10)Group V: Cavities were treated with bromelain enzyme solution', 'bromelain enzyme', 'external bleaching with 35% hydrogen peroxide', 'antioxidants', 'External bleaching with 35% hydrogen peroxide']","['microleakage', 'least amount of microleakage', 'greatest amount of microleakage', 'Microleakage', 'amount of microleakage']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C0457166', 'cui_str': 'Class 5'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}, {'cui': 'C0009570', 'cui_str': 'Composite Resins'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0040431', 'cui_str': 'Bleaching of discolored tooth'}]","[{'cui': 'C0887557', 'cui_str': 'Sodium Ascorbate'}, {'cui': 'C0303749', 'cui_str': 'Bleach'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0006217', 'cui_str': 'Bromelains'}, {'cui': 'C0014442', 'cui_str': 'Enzyme'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0020281', 'cui_str': 'Hydrogen Peroxide'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}]","[{'cui': 'C0205393', 'cui_str': 'Most'}]",,0.0136569,"Groups III, IV, and V showed a significantly lower amount of microleakage compared to Group II ( P  < 0.05).","[{'ForeName': 'Aarti', 'Initials': 'A', 'LastName': 'Mulgaonkar', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Goa Dental College and Hospital, Bambolim, Goa, India.'}, {'ForeName': 'Ida de Noronha', 'Initials': 'IN', 'LastName': 'de Ataide', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Goa Dental College and Hospital, Bambolim, Goa, India.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Fernandes', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Goa Dental College and Hospital, Bambolim, Goa, India.'}, {'ForeName': 'Rajan', 'Initials': 'R', 'LastName': 'Lambor', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Goa Dental College and Hospital, Bambolim, Goa, India.'}, {'ForeName': 'Renita', 'Initials': 'R', 'LastName': 'Soares', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Goa Dental College and Hospital, Bambolim, Goa, India.'}]",Journal of conservative dentistry : JCD,['10.4103/JCD.JCD_340_19']
1773,33082667,Evaluation of the effect of collagen stabilizing agents like chitosan and proanthocyanidin on the shear bond strength to dentin and microleakage of resin composite at enamel and cemental walls: An  in vitro  study.,"Objectives


The objective is to evaluate the effect of collagen stabilizing agents-chitosan and proanthocyanidin (PA) on the shear bond strength to dentin and microleakage of resin composite at enamel and cemental walls.
Materials and Methods


Thirty premolars were decoronated 2 mm above cemento-enamel junction and restored with composite resin. Teeth were then randomly divided into three groups: Group I - Control, Group II - Pre-treatment with chitosan, and Group III - Pre-treatment with PA. Samples were then subjected to thermocycling for 500 cycles at 5°C and 55°C with the dwell time of 30 s and transfer time of 5-10 s. Then, the samples were subjected to shear bond strength evaluation on Universal testing machine. Shear load was applied until failure occurred. The load to failure was recorded individually and statistical analysis was done. Microleakage was determined by methylene blue dye penetration method and subjected to stereomicroscopic evaluation. Statistical analysis was carried out using Mann-Whitney test and Chi-square test.
Results


Group II specimens produced the highest median shear bond strength and group I showed the least. In addition, Group I, Group II, and Group III showed no statistically significant difference in microleakage.
Conclusions


Application of Chitosan and PA improved the shear bond strength to dentin as compared to the control. However, no significant difference in shear bond strength and microleakage was found between them.",2019,"However, no significant difference in shear bond strength and microleakage was found between them.",['dentin and microleakage of resin composite at enamel and cemental walls'],"['collagen stabilizing agents-chitosan and proanthocyanidin (PA', 'collagen stabilizing agents like chitosan and proanthocyanidin', 'Group I - Control, Group II - Pre-treatment with chitosan, and Group III - Pre-treatment with PA']","['load to failure', 'microleakage', 'shear bond strength', 'highest median shear bond strength', 'shear bond strength and microleakage']","[{'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0009570', 'cui_str': 'Composite Resins'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C0205380', 'cui_str': 'Walled'}]","[{'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0038113', 'cui_str': 'Stabilizing Agents'}, {'cui': 'C0162969', 'cui_str': 'Chitosan'}, {'cui': 'C0072018', 'cui_str': 'Proanthocyanidin'}, {'cui': 'C0441843', 'cui_str': 'Group I'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0175735', 'cui_str': 'Scissors'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",30.0,0.0166358,"However, no significant difference in shear bond strength and microleakage was found between them.","[{'ForeName': 'Lukram', 'Initials': 'L', 'LastName': 'Nivedita', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Sree Balaji Dental College and Hospital, Bharath Institute of Higher Education and Research, Chennai, Tamil Nadu, India.'}, {'ForeName': 'Venkatachalam', 'Initials': 'V', 'LastName': 'Prakash', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Sree Balaji Dental College and Hospital, Bharath Institute of Higher Education and Research, Chennai, Tamil Nadu, India.'}, {'ForeName': 'Suresh', 'Initials': 'S', 'LastName': 'Mitthra', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Sree Balaji Dental College and Hospital, Bharath Institute of Higher Education and Research, Chennai, Tamil Nadu, India.'}, {'ForeName': 'Newbegin Selvakumar Gold', 'Initials': 'NSG', 'LastName': 'Pearlin Mary', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Sree Balaji Dental College and Hospital, Bharath Institute of Higher Education and Research, Chennai, Tamil Nadu, India.'}, {'ForeName': 'Alagarsamy', 'Initials': 'A', 'LastName': 'Venkatesh', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Sree Balaji Dental College and Hospital, Bharath Institute of Higher Education and Research, Chennai, Tamil Nadu, India.'}, {'ForeName': 'Arunajatesan', 'Initials': 'A', 'LastName': 'Subbiya', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Sree Balaji Dental College and Hospital, Bharath Institute of Higher Education and Research, Chennai, Tamil Nadu, India.'}]",Journal of conservative dentistry : JCD,['10.4103/JCD.JCD_195_20']
1774,33082712,Essential Oil and Juice from Bergamot and Sweet Orange Improve Acne Vulgaris Caused by Excessive Androgen Secretion.,"Acne vulgaris is one of the most common chronic inflammatory skin diseases. Bergamot and sweet orange are rich in nutritional and functional components, which exhibit antioxidant, anti-inflammatory, and antiapoptotic effect. The aim of this study was to evaluate the potential effect of bergamot and sweet orange (juice and essential oil) on acne vulgaris caused by excessive secretion of androgen. Eighty male golden hamsters were randomly divided into 10 groups and received low or high dose of bergamot and sweet orange juice and essential oil, physiological saline, and positive drugs for four weeks, respectively. Results showed that all interventions could improve acne vulgaris by reducing the growth rate of sebaceous gland spots, inhibiting TG accumulation, decreasing the release of inflammatory cytokines (notably reducing IL-1 α  levels), promoting apoptosis in the sebaceous gland, and decreasing the ratio of T/E 2 . Among them, bergamot and orange essential oil may have better effects (dose dependent) on alleviating acne vulgaris than the corresponding juice. In view of the large population of acne patients and the widespread use of sweet orange and bergamot, this study is likely to exert an extensive and far-reaching influence.",2020,"Results showed that all interventions could improve acne vulgaris by reducing the growth rate of sebaceous gland spots, inhibiting TG accumulation, decreasing the release of inflammatory cytokines (notably reducing IL-1 α  levels), promoting apoptosis in the sebaceous gland, and decreasing the ratio of T/E 2 .","['Improve Acne Vulgaris', 'Eighty male golden hamsters']","['low or high dose of bergamot and sweet orange juice and essential oil, physiological saline', 'bergamot and sweet orange (juice and essential oil', 'Essential Oil and Juice from Bergamot and Sweet Orange']","['acne vulgaris', 'release of inflammatory cytokines', 'growth rate of sebaceous gland spots, inhibiting TG accumulation']","[{'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0001144', 'cui_str': 'Acne vulgaris'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0018561', 'cui_str': 'Mesocricetus auratus'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C3715207', 'cui_str': 'Bergamot orange extract'}, {'cui': 'C0522462', 'cui_str': 'Citrus sinensis'}, {'cui': 'C1268568', 'cui_str': 'Juice'}, {'cui': 'C0028910', 'cui_str': 'Volatile oil'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0001144', 'cui_str': 'Acne vulgaris'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0449249', 'cui_str': 'Growth rate'}, {'cui': 'C0036505', 'cui_str': 'Sebaceous gland structure'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}]",80.0,0.0334803,"Results showed that all interventions could improve acne vulgaris by reducing the growth rate of sebaceous gland spots, inhibiting TG accumulation, decreasing the release of inflammatory cytokines (notably reducing IL-1 α  levels), promoting apoptosis in the sebaceous gland, and decreasing the ratio of T/E 2 .","[{'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Sun', 'Affiliation': 'Beijing Key Laboratory of Functional Food from Plant Resources, College of Food Science and Nutritional Engineering, China Agricultural University, Beijing 100083, China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': 'Beijing Advance Innovation Center for Food Nutrition and Human Health, Beijing Engineering and Technology Research Center of Food Additives, Beijing Technology and Business University, Beijing 100048, China.'}, {'ForeName': 'Nanhai', 'Initials': 'N', 'LastName': 'Zhang', 'Affiliation': 'Beijing Key Laboratory of Functional Food from Plant Resources, College of Food Science and Nutritional Engineering, China Agricultural University, Beijing 100083, China.'}, {'ForeName': 'Chengtao', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Beijing Advance Innovation Center for Food Nutrition and Human Health, Beijing Engineering and Technology Research Center of Food Additives, Beijing Technology and Business University, Beijing 100048, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wu', 'Affiliation': 'College of Engineering, China Agricultural University, Beijing 100083, China.'}, {'ForeName': 'Arshad', 'Initials': 'A', 'LastName': 'Mehmood', 'Affiliation': 'Beijing Advance Innovation Center for Food Nutrition and Human Health, Beijing Engineering and Technology Research Center of Food Additives, Beijing Technology and Business University, Beijing 100048, China.'}, {'ForeName': 'Liebing', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Beijing Key Laboratory of Functional Food from Plant Resources, College of Food Science and Nutritional Engineering, China Agricultural University, Beijing 100083, China.'}, {'ForeName': 'Baoping', 'Initials': 'B', 'LastName': 'Ji', 'Affiliation': 'Beijing Key Laboratory of Functional Food from Plant Resources, College of Food Science and Nutritional Engineering, China Agricultural University, Beijing 100083, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Zhou', 'Affiliation': 'Beijing Key Laboratory of Functional Food from Plant Resources, College of Food Science and Nutritional Engineering, China Agricultural University, Beijing 100083, China.'}]",Mediators of inflammation,['10.1155/2020/8868107']
1775,33082830,"Effectiveness of Hydrogalvanic Bath on Improving Pain, Disability, and Quality of Life in Individuals with Chronic Nonspecific Neck Pain: A Randomized Controlled Trial.","Background


Neck pain is one of the world's leading factors in years lived with disability. Ambiguity in the effect of electrotherapy modalities for the treatment of chronic nonspecific neck pains (CNSNP) needs to be examined further. This study sought to elucidate the effectiveness of hydrogalvanic bath on improving pain, disability, and quality of life among individuals with CNSNP.
Methods


Thirty-four individuals with a diagnosis of CNSNP were selected through convenient sampling and randomly divided into two groups by block randomization. The control group treatment underwent low Transcutaneous Electrical Nerve Stimulation (TENS) and exercise, and the experimental group was subjected to hydrogalvanic bath therapy (HGBT) and exercise. Individuals were evaluated for pain using a visual analog scale (VAS), disability with the Neck Disability Index (NDI), and quality of life with Short Form-36 (SF-36). These measures were applied at baseline and after 12 weeks of treatment.
Results


The pretreatment and posttreatment results for VAS, NDI, and SF-36 were compared for both control and experimental groups. We found that all the three variables showed significant differences between the two time points with  p  < 0.05 in both the groups but the experimental group improvements were more significant than the control group with  p  < 0.05.
Conclusion


Twelve weeks of low TENS or HGBT along with exercises can decrease pain and neck disability and increase the quality of life in individuals with CNSNP. However, HGBT along with exercise has superior effects relative to low TENS along with exercise. This randomized controlled trial was registered in the International Standard Randomized Controlled Trials Number-ISRCTN29695190 and registered on 05/02/2020. This study is a retrospective registration.",2020,"The pretreatment and posttreatment results for VAS, NDI, and SF-36 were compared for both control and experimental groups.","['individuals with CNSNP', 'Methods\n\n\nThirty-four individuals with a diagnosis of CNSNP', 'years lived with disability', 'chronic nonspecific neck pains (CNSNP', 'Individuals with Chronic Nonspecific Neck Pain']","['low Transcutaneous Electrical Nerve Stimulation (TENS) and exercise, and the experimental group was subjected to hydrogalvanic bath therapy (HGBT) and exercise', 'hydrogalvanic bath', 'Hydrogalvanic Bath', 'low TENS or HGBT', 'electrotherapy modalities', 'HGBT']","['Pain, Disability, and Quality of Life', 'pain and neck disability', 'pain, disability, and quality of life', 'pain using a visual analog scale (VAS), disability with the Neck Disability Index (NDI), and quality of life with Short Form-36 (SF-36', 'VAS, NDI, and SF-36', 'quality of life']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0231170', 'cui_str': 'Disability'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0040654', 'cui_str': 'Percutaneous electrical nerve stimulation'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1504484', 'cui_str': 'Bath therapy'}, {'cui': 'C0013787', 'cui_str': 'Electrotherapy'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}]",34.0,0.097988,"The pretreatment and posttreatment results for VAS, NDI, and SF-36 were compared for both control and experimental groups.","[{'ForeName': 'Mastour Saeed', 'Initials': 'MS', 'LastName': 'Alshahrani', 'Affiliation': 'Department of Medical Rehabilitation Sciences, College of Applied Medical Sciences, King Khalid University, Abha, Saudi Arabia.'}, {'ForeName': 'Jaya Shanker', 'Initials': 'JS', 'LastName': 'Tedla', 'Affiliation': 'Department of Medical Rehabilitation Sciences, College of Applied Medical Sciences, King Khalid University, Abha, Saudi Arabia.'}, {'ForeName': 'Ravi Shankar', 'Initials': 'RS', 'LastName': 'Reddy', 'Affiliation': 'Department of Medical Rehabilitation Sciences, College of Applied Medical Sciences, King Khalid University, Abha, Saudi Arabia.'}, {'ForeName': 'Faisal', 'Initials': 'F', 'LastName': 'Asiri', 'Affiliation': 'Department of Medical Rehabilitation Sciences, College of Applied Medical Sciences, King Khalid University, Abha, Saudi Arabia.'}]",Evidence-based complementary and alternative medicine : eCAM,['10.1155/2020/7974816']
1776,33082832,"A Randomized, Triple-Blind, Placebo-Controlled, Add-On Clinical Trial to Evaluate the Efficacy of  Emblica officinalis  in Uncontrolled Hypertension.","Introduction. Emblica officinalis  (EO) has some cardiovascular effects, and there are some animal studies that show its antihypertensive effect. This study was conducted to determine the effect of combination of EO with standard therapy on the systolic blood pressure (SBP) and diastolic blood pressure (DBP) in patients with uncontrolled hypertension.  Materials and Methods.  This was a randomized, triple-blind, placebo-controlled, 8-week study. Ninety-two patients with uncontrolled hypertension despite taking hypotensive drugs were randomly assigned into two groups to take EO (500 mg/TDS after meal) or placebo in combination with standard antihypertensive drugs. After 2, 4, 6, and 8 weeks of intervention, SBP and DBP and heart rate (HR) were measured. Data were analyzed by SPSS software using repeated measures ANOVA.  Results.  Eighty-one patients (41 in the drug group and 40 in the placebo group) completed the study for 8 weeks and were analyzed. The mean ± standard deviation of age was 53.64 ± 10.01 years. SBP decreased as 15.6 ± 8.23% in the EO group and 6.3 ± 7.49% in the placebo group ( P  < 0.001). DBP decreased as 12.3 ± 7.87% and 3.88 ± 7.98%, respectively ( P  < 0.001). Time effect was not significant, but the group effect was significant ( F  = 13.875,  P =0.001 for systolic BP and  F  = 18.948,  P  < 0.001 for diastolic BP). No side effects were reported during the study.  Conclusion.  Eight-week combination therapy of EO with standard antihypertensive drugs significantly reduced the SBP and DBP more than placebo in patients with uncontrolled hypertension.",2020,"Time effect was not significant, but the group effect was significant ( F  = 13.875,  P =0.001 for systolic BP and  F  = 18.948,  P  < 0.001 for diastolic BP).","['Uncontrolled Hypertension', 'patients with uncontrolled hypertension', 'Ninety-two patients with uncontrolled hypertension despite taking hypotensive drugs', 'Eighty-one patients (41 in the drug group and 40 in the placebo group) completed the study for 8 weeks and were analyzed']","['EO with standard therapy', 'EO (500\u2009mg/TDS after meal) or placebo in combination with standard antihypertensive drugs', 'Placebo-Controlled, Add', 'placebo', 'Emblica officinalis  (EO']","['DBP', 'SBP and DBP', 'SBP and DBP and heart rate (HR', 'side effects', 'Time effect', 'systolic blood pressure (SBP) and diastolic blood pressure (DBP', 'SBP']","[{'cui': 'C1868885', 'cui_str': 'Uncontrolled hypertension'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C4517884', 'cui_str': '81'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0172161', 'cui_str': 'tyramine-deoxysorbitol'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0969742', 'cui_str': 'Amla'}]","[{'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}]",92.0,0.164625,"Time effect was not significant, but the group effect was significant ( F  = 13.875,  P =0.001 for systolic BP and  F  = 18.948,  P  < 0.001 for diastolic BP).","[{'ForeName': 'Samad', 'Initials': 'S', 'LastName': 'Ghaffari', 'Affiliation': 'Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Navabzadeh', 'Affiliation': 'Research Institute for Islamic and Complementary Medicine, School of Persian Medicine, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mojtaba', 'Initials': 'M', 'LastName': 'Ziaee', 'Affiliation': 'Medicinal Plants Research Center, Maragheh University of Medical Sciences, Maragheh, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Ghobadi', 'Affiliation': 'Research Institute for Islamic and Complementary Medicine, School of Persian Medicine, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Roshanak', 'Initials': 'R', 'LastName': 'Ghods', 'Affiliation': 'Research Institute for Islamic and Complementary Medicine, School of Persian Medicine, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Fataneh', 'Initials': 'F', 'LastName': 'Hashem-Dabaghian', 'Affiliation': 'Research Institute for Islamic and Complementary Medicine, School of Persian Medicine, Iran University of Medical Sciences, Tehran, Iran.'}]",Evidence-based complementary and alternative medicine : eCAM,['10.1155/2020/8592869']
1777,33082834,Antarctic Krill Oil Attenuates Oxidative Stress via the KEAP1-NRF2 Signaling in Patients with Coronary Heart Disease.,"Background


Antarctic krill oil (AKO) has strong antioxidant activities and is effective for alleviating coronary heart disease (CHD). Kelch-like ECH-associated protein 1-NF-E2-related factor 2 (KEAP1-NRF2) axis is a crucial antioxidant signaling pathway. Thus, AKO may exert its antioxidant effects on CHD patients via KEAP1-NRF2 signaling.
Methods


AKO fatty acid (FA) profiles were analyzed by using gas chromatography (GC). One hundred CHD patients were divided into the intervention (IG, AKO) and control (CG, placebo) groups. Before and after 1, 2, and 3 months of intervention, we measured serum levels of reactive oxygen species (ROS), 8-hydroxy-2-deoxyguanosine (8-OHdG), nitric oxide (NO), malondialdehyde (MDA), superoxide dismutase (SOD), reduced glutathione (GSH), and glutathione peroxidase (GPx), and KEAP1 and NRF2 levels in peripheral blood leukocytes (PBLs). Serum FAs were measured by GC at baseline and after 3-month intervention.
Results


AKO contains rich eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), which is more than 27% of total FA. The levels of EPA and DHA, KEAP1, and NRF2 in the IG group were higher than those in the CG group ( p  < 0.05). Serum levels of ROS, 8-OHdG, NO, and MDA in the IG group were lower than those in the CG group, whereas the levels of SOD, GSH, and GPx in the IG group were higher than those in the CG group ( p  < 0.05). Serum levels of saturated fatty acids (UFA) in the IG group were higher than those in the CG group, whereas reverse results were obtained for the levels of saturated fatty acids (SFA). Serum levels of EPA and DHA had a strong negative relationship with the level of ROS, whereas the ROS level had a strong negative relationship with the levels of KEAP1-NRF2.
Conclusion


AKO increases antioxidant capacities of CHD patients via the KEAP1-NRF2 signaling in the PBL.",2020,"Serum levels of saturated fatty acids (UFA) in the IG group were higher than those in the CG group, whereas reverse results were obtained for the levels of saturated fatty acids (SFA).","['One hundred CHD patients', 'Patients with Coronary Heart Disease']","['eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA', 'intervention (IG, AKO) and control (CG, placebo', '\n\n\nAntarctic krill oil (AKO', 'Antarctic Krill Oil']","['Serum levels of EPA and DHA', 'serum levels of reactive oxygen species (ROS), 8-hydroxy-2-deoxyguanosine (8-OHdG), nitric oxide (NO), malondialdehyde (MDA), superoxide dismutase (SOD), reduced glutathione (GSH), and glutathione peroxidase (GPx), and KEAP1 and NRF2 levels in peripheral blood leukocytes (PBLs', 'levels of EPA and DHA, KEAP1, and NRF2', 'levels of SOD, GSH, and GPx', 'Serum FAs', 'antioxidant capacities', 'Serum levels of ROS, 8-OHdG, NO, and MDA', 'Serum levels of saturated fatty acids (UFA', 'Methods\n\n\nAKO fatty acid (FA) profiles']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0454691', 'cui_str': 'Antarctica'}, {'cui': 'C2725341', 'cui_str': 'krill oil'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0162772', 'cui_str': 'Oxygen Species, Reactive'}, {'cui': 'C0050078', 'cui_str': '8-hydroxy-deoxyguanosine'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0017822', 'cui_str': 'Glutathione peroxidase'}, {'cui': 'C0967993', 'cui_str': 'KEAP1 protein, human'}, {'cui': 'C1565078', 'cui_str': 'NFE2L2 protein, human'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0597423', 'cui_str': 'Saturated fat'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0454691', 'cui_str': 'Antarctica'}, {'cui': 'C2725341', 'cui_str': 'krill oil'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}]",100.0,0.0320814,"Serum levels of saturated fatty acids (UFA) in the IG group were higher than those in the CG group, whereas reverse results were obtained for the levels of saturated fatty acids (SFA).","[{'ForeName': 'Chengfei', 'Initials': 'C', 'LastName': 'Wen', 'Affiliation': 'Department of Cardiology, The First Hospital of Jilin University, Changchun 130021, China.'}, {'ForeName': 'Mi', 'Initials': 'M', 'LastName': 'Jiang', 'Affiliation': 'Department of Cardiac Surgery, The First Hospital of Jilin University, Changchun 130021, China.'}, {'ForeName': 'Weixin', 'Initials': 'W', 'LastName': 'Huang', 'Affiliation': 'Department of Geriatrics, The First Hospital of Jilin University, Changchun 130021, China.'}, {'ForeName': 'Shumei', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Department of Endocrinology, The First Hospital of Jilin University, Changchun 130031, China.'}]",Evidence-based complementary and alternative medicine : eCAM,['10.1155/2020/9534137']
1778,33082862,Comparison of the efficacy of ambroxol hydrochloride and  N  -acetylcysteine in the treatment of children with bronchopneumonia and their influence on prognosis.,"The aim of the present study was to compare the efficacy of ambroxol hydrochloride and  N -acetylcysteine in the treatment of children with bronchial pneumonia and their influence on prognosis. A total of 120 children with bronchial pneumonia, admitted to The Affiliated Yantai Yuhuangding Hospital of Qingdao University from July 2015 to August 2018, were enrolled in the study. Among them, 58 children were treated with  N -acetylcysteine and comprised the experimental group, and 62 children were treated with ambroxol hydrochloride and comprised the control group. Children's physical signs (such as fever, short breath, cough and pulmonary rales) and the adverse reactions to treatment were observed, and the disappearance time of the signs was recorded. In addition, the cellular immune function indicators and the quality of life after treatment were investigated. There was no significant difference in clinical data between the two groups (P>0.05). The effective rate in the experimental group was significantly higher than that in the control group (P<0.05). The disappearance time of symptoms, such as fever, cough, asthma and rales in the lung, was significantly shorter in the experimental group than that in the control group (P<0.05). The hospitalization time of patients in the experimental group was shorter than that in the control group (P<0.05). After treatment, immunoglobulin A (IgA), immunoglobulin G (IgG), immunoglobulin M (IgM) and complement C3 were significantly increased in the experimental group (P<0.01), and the IgA and IgG in the experimental group were significantly higher than those in the control group (P<0.01). The incidence of adverse reactions in the experimental group was significantly lower than that in the control group (P<0.05). In conclusion,  N -acetylcysteine has a significant effect on the treatment of bronchopneumonia in children providing a quick relief from symptoms, such as lung rales, and therefore is worthy of use in clinic.",2020,The effective rate in the experimental group was significantly higher than that in the control group (P<0.05).,"['children with bronchopneumonia and their influence on prognosis', '58 children were treated with  N -acetylcysteine and comprised the experimental group, and 62 children', 'children with bronchial pneumonia and their influence on prognosis', '120 children with bronchial pneumonia, admitted to The Affiliated Yantai Yuhuangding Hospital of Qingdao University from July 2015 to August 2018, were enrolled in the study']","['ambroxol hydrochloride and  N  -acetylcysteine', 'ambroxol hydrochloride and  N -acetylcysteine', 'ambroxol hydrochloride']","['disappearance time of symptoms, such as fever, cough, asthma and rales in the lung', ""Children's physical signs (such as fever, short breath, cough and pulmonary rales"", 'clinical data', 'immunoglobulin A (IgA), immunoglobulin G (IgG), immunoglobulin M (IgM) and complement C3', 'IgA and IgG', 'incidence of adverse reactions', 'hospitalization time', 'quality of life', 'effective rate']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0006285', 'cui_str': 'Bronchopneumonia'}, {'cui': 'C0033325', 'cui_str': 'Determination of prognosis'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C1367795', 'cui_str': 'Ambroxol hydrochloride'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0225386', 'cui_str': 'Breath'}, {'cui': 'C0034642', 'cui_str': 'Respiratory crackles'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0020861', 'cui_str': 'Immunoglobulin M'}, {'cui': 'C0009506', 'cui_str': 'Complement component C3'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",120.0,0.0161817,The effective rate in the experimental group was significantly higher than that in the control group (P<0.05).,"[{'ForeName': 'Hongbo', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of Pediatrics, The Affiliated Yantai Yuhuangding Hospital of Qingdao University, Yantai, Shandong 264000, P.R. China.'}, {'ForeName': 'Wenxiao', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Pediatrics, The Affiliated Yantai Yuhuangding Hospital of Qingdao University, Yantai, Shandong 264000, P.R. China.'}, {'ForeName': 'Xingjuan', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': 'Department of Pediatrics, The Affiliated Yantai Yuhuangding Hospital of Qingdao University, Yantai, Shandong 264000, P.R. China.'}]",Experimental and therapeutic medicine,['10.3892/etm.2020.9260']
1779,33074857,0.1. Association of plasma sVCAM-1 and sCD14 with mortality in HIV-1 infected West African adults with high CD4 counts.,"BACKGROUND


Several biomarkers of inflammation and coagulation were reported to be associated with HIV disease progression in different settings. Here we report the association between eleven biomarkers and medium-term mortality in HIV-infected West Africa adults.
METHODS


In Temprano ANRS 12136, ART-naïve HIV-infected adults with high CD4 counts were randomly assigned either to start ART immediately or defer ART until the WHO criteria were met. Participants who completed the 30-month trial follow-up were invited to participate in a post-trial phase (PTP). The PTP endpoint was all-cause death. We used multivariate Cox proportional models to analyze the association between baseline plasma biomarkers (IL-1ra, IL-6, sVCAM-1, sCD14, D-dimer, Fibrinogen, IP-10, sCD163, albumin, hsCRP, 16S rDNA) and all-cause death in the Temprano participants randomized to defer ART.
RESULTS


477 patients (median age 35, 78% women, median CD4 count: 379 cells/mm) were randomly assigned to defer starting ART until the WHO criteria were met. The participants were followed for 2646 person-years (median 5.8 years). In the follow-up, 89% of participants started ART and 30 died. In the multivariate analysis adjusted for the study center, sex, baseline CD4 count, isoniazid preventive therapy, plasma HIV-1 RNA, PBMC HIV-1 DNA and ART, the risk of death was significantly associated with baseline sVCAM-1 (≥ 1458 vs. < 1458: adjusted hazard ratio [aHR] 2.57, 95% CI 1.13-5.82) and sCD14 (≥ 2187 vs. < 2187: aHR 2.79, IQR 1.29-6.02) levels.
CONCLUSION


In these sub-Saharan African adults with high CD4 counts, pre-ART plasma sVCAM-1 and sCD14 levels were independently associated with mortality.",2020,"We used multivariate Cox proportional models to analyze the association between baseline plasma biomarkers (IL-1ra, IL-6, sVCAM-1, sCD14, D-dimer, Fibrinogen, IP-10, sCD163, albumin, hsCRP, 16S rDNA) and all-cause death in the Temprano participants randomized to defer ART.
","['Participants who completed the 30-month trial follow-up were invited to participate in a post-trial phase (PTP', 'HIV-infected West Africa adults', 'participants were followed for 2646 person-years (median 5.8 years', 'HIV-1 infected West African adults with high CD4 counts', 'In Temprano ANRS 12136, ART-naïve HIV-infected adults with high CD4 counts', '477 patients (median age 35, 78% women, median CD4 count: 379 cells/mm']",[],"['high CD4 counts, pre-ART plasma sVCAM-1 and sCD14 levels', 'baseline CD4 count, isoniazid preventive therapy, plasma HIV-1 RNA, PBMC HIV-1 DNA and ART, the risk of death', 'baseline plasma biomarkers (IL-1ra, IL-6, sVCAM-1, sCD14, D-dimer, Fibrinogen, IP-10, sCD163, albumin, hsCRP, 16S rDNA) and all-cause death']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0001747', 'cui_str': 'Western Africa'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C4517796', 'cui_str': '5.8'}, {'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C0037769', 'cui_str': 'West syndrome'}, {'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}]",[],"[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0022209', 'cui_str': 'isoniazid'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0369499', 'cui_str': 'Human immunodeficiency virus 1 RNA'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C0486948', 'cui_str': 'Human immunodeficiency virus 1 DNA'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0245109', 'cui_str': 'anakinra'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0060323', 'cui_str': 'D-dimer'}, {'cui': 'C0016006', 'cui_str': 'Fibrinogen'}, {'cui': 'C1308752', 'cui_str': 'CXCL10 protein, human'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0012931', 'cui_str': 'Recombinant DNA'}]",,0.303143,"We used multivariate Cox proportional models to analyze the association between baseline plasma biomarkers (IL-1ra, IL-6, sVCAM-1, sCD14, D-dimer, Fibrinogen, IP-10, sCD163, albumin, hsCRP, 16S rDNA) and all-cause death in the Temprano participants randomized to defer ART.
","[{'ForeName': 'Roseline', 'Initials': 'R', 'LastName': 'Affi', 'Affiliation': ""CeDReS, CHU de Treichville, Abidjan, Côte d'Ivoire.""}, {'ForeName': 'Delphine', 'Initials': 'D', 'LastName': 'Gabillard', 'Affiliation': ""PACCI-ANRS research site, Côte d'Ivoire.""}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Dunyach-Remy', 'Affiliation': 'VBMI, INSERM U1047, Université de Montpellier, Service de Microbiologie et Hygiène Hospitalière, CHU de Carémeau, Nîmes, France.'}, {'ForeName': 'Jean-Baptiste', 'Initials': 'JB', 'LastName': 'Ntakpe', 'Affiliation': ""PACCI-ANRS research site, Côte d'Ivoire.""}, {'ForeName': 'Raoul', 'Initials': 'R', 'LastName': 'Moh', 'Affiliation': ""PACCI-ANRS research site, Côte d'Ivoire.""}, {'ForeName': 'Anani', 'Initials': 'A', 'LastName': 'Badje', 'Affiliation': ""PACCI-ANRS research site, Côte d'Ivoire.""}, {'ForeName': 'Gérard M', 'Initials': 'GM', 'LastName': 'Kouame', 'Affiliation': ""PACCI-ANRS research site, Côte d'Ivoire.""}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Karcher', 'Affiliation': ""PACCI-ANRS research site, Côte d'Ivoire.""}, {'ForeName': 'Jérome', 'Initials': 'J', 'LastName': 'Le Carrou', 'Affiliation': ""PACCI-ANRS research site, Côte d'Ivoire.""}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Danel', 'Affiliation': ""PACCI-ANRS research site, Côte d'Ivoire.""}, {'ForeName': 'Mathieu F', 'Initials': 'MF', 'LastName': 'Chevalier', 'Affiliation': 'INSERM U976, Laboratory of Human Immunology, Pathophysiology and Immunotherapy, Hôpital Saint-Louis, Paris, France.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Rouzioux', 'Affiliation': 'AP-HP, CHU Necker Enfants Malades, EA 7327 Université Paris Descartes, Paris, France.'}, {'ForeName': 'Serge P', 'Initials': 'SP', 'LastName': 'Eholie', 'Affiliation': ""PACCI-ANRS research site, Côte d'Ivoire.""}, {'ForeName': 'Jean-Philippe', 'Initials': 'JP', 'LastName': 'Lavigne', 'Affiliation': 'VBMI, INSERM U1047, Université de Montpellier, Service de Microbiologie et Hygiène Hospitalière, CHU de Carémeau, Nîmes, France.'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Inwoley', 'Affiliation': ""CeDReS, CHU de Treichville, Abidjan, Côte d'Ivoire.""}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Anglaret', 'Affiliation': ""PACCI-ANRS research site, Côte d'Ivoire.""}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Weiss', 'Affiliation': 'Université de Paris, Institut de Recherche Saint Louis, Hôpital Saint-Louis, Paris, France.'}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002533']
1780,33074880,"Comment on ""Efficacy and Safety of Complete Mesocolic Excision in Patients With Colon Cancer: Three-Year Results From a Prospective, Nonrandomized, Double-Blind, Controlled Trial"".",,2020,,['Patients With Colon Cancer'],['Complete Mesocolic Excision'],['Efficacy and Safety'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007102', 'cui_str': 'Malignant tumor of colon'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.211155,,"[{'ForeName': 'Amine', 'Initials': 'A', 'LastName': 'Souadka', 'Affiliation': 'Surgical Oncology Department, National Institute of Oncology, Faculté de Médecine, Mohammed V University in Rabat, Morocco Surgical Oncology Department, National Institute of Oncology, Faculté de Médecine, Mohammed V University in Rabat, Morocco Surgical Oncology Department, National Institute of Oncology, Faculté de Médecine, Mohammed V University in Rabat, Morocco Surgical Oncology Department, National Institute of Oncology, Faculté de Médecine, Mohammed V University in Rabat, Morocco Surgical Oncology Department, National Institute of Oncology, Faculté de Médecine, Mohammed V University in Rabat, Morocco Surgical Oncology Department, National Institute of Oncology, Faculté de Médecine, Mohammed V University in Rabat, Morocco Colorectal Surgical Department, Hôpital Beaujon (AP-HP). Université Paris 7. 100 bd du général Leclerc, 92110 CLICHY France.'}, {'ForeName': 'Mohammed Anass', 'Initials': 'MA', 'LastName': 'Majbar', 'Affiliation': ''}, {'ForeName': 'Hajar', 'Initials': 'H', 'LastName': 'Essangri', 'Affiliation': ''}, {'ForeName': 'Amine', 'Initials': 'A', 'LastName': 'Benkabbou', 'Affiliation': ''}, {'ForeName': 'Laila', 'Initials': 'L', 'LastName': 'Amrani', 'Affiliation': ''}, {'ForeName': 'Raouf', 'Initials': 'R', 'LastName': 'Mohsine', 'Affiliation': ''}, {'ForeName': 'Leon', 'Initials': 'L', 'LastName': 'Maggiori', 'Affiliation': ''}]",Annals of surgery,['10.1097/SLA.0000000000004284']
1781,33074892,A Health Economic Evaluation of the World Health Organization Surgical Safety Checklist: A Single Center Assessment.,"OBJECTIVES


To evaluate cost-effectiveness of the WHO Surgical Safety Checklist.
BACKGROUND


The clinical effectiveness of surgical checklists is largely understood. Few studies to-date have evaluated the cost-effectiveness of checklist use.
METHODS


An economic evaluation was carried out using data from the only available randomized controlled trial of the checklist. Analyses were based on 3702 procedures. Costs considered included checklist implementation costs and length and cost of hospital stay, costs of warming blanket use, blood transfusions and antibiotics used in the operating room, and the cost of clinical time in the operating room - all calculated for each procedure and its associated admission. Nonparametric bootstrapping was used to simulate an empirical distribution of the mean effect of the checklist on total admission costs and the probability of observing a complication-free admission and to quantify sampling uncertainty around mean cost estimates.
RESULTS


The overall cost of checklist implementation was calculated to be $900 per 100 admissions. Implementation of the WHO checklist resulted in an additional 5.9 complication-free admissions per 100 admissions and an average of 110 bed-days saved per 100 admissions. Accounting for all costs included in the analysis, for every 100 admissions, use of the WHO checklist was estimated to save $55,899.
CONCLUSIONS


Implementation of the WHO checklist was a cost-effective strategy for improving surgical safety.",2020,Implementation of the WHO checklist resulted in an additional 5.9 complication-free admissions per 100 admissions and an average of 110 bed-days saved per 100 admissions.,[],[],"['total admission costs', 'surgical safety', 'overall cost of checklist implementation', 'checklist implementation costs and length and cost of hospital stay, costs of warming blanket use, blood transfusions and antibiotics used in the operating room, and the cost of clinical time']",[],[],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0184351', 'cui_str': 'Warming blanket'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.025763,Implementation of the WHO checklist resulted in an additional 5.9 complication-free admissions per 100 admissions and an average of 110 bed-days saved per 100 admissions.,"[{'ForeName': 'Andy', 'Initials': 'A', 'LastName': 'Healey', 'Affiliation': ""Center for Implementation Science, Health Service, and Population Research Department, King's College London, London, United Kingdom.""}, {'ForeName': 'Eirik', 'Initials': 'E', 'LastName': 'Søfteland', 'Affiliation': 'Department of Anesthesia and Intensive Care, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Stig', 'Initials': 'S', 'LastName': 'Harthug', 'Affiliation': 'Department of Clinical Science, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Rune', 'Initials': 'R', 'LastName': 'Haaverstad', 'Affiliation': 'Department of Clinical Science, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Rupavathana', 'Initials': 'R', 'LastName': 'Mahesparan', 'Affiliation': 'Department of Neurosurgery, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Bjørg Merete', 'Initials': 'BM', 'LastName': 'Hjallen', 'Affiliation': 'Department of Orthopedic Surgery, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Geir Egil', 'Initials': 'GE', 'LastName': 'Eide', 'Affiliation': 'Center for Clinical Research, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Sevdalis', 'Affiliation': ""Center for Implementation Science, Health Service, and Population Research Department, King's College London, London, United Kingdom.""}, {'ForeName': 'Arvid Steinar', 'Initials': 'AS', 'LastName': 'Haugen', 'Affiliation': 'Department of Anesthesia and Intensive Care, Haukeland University Hospital, Bergen, Norway.'}]",Annals of surgery,['10.1097/SLA.0000000000004300']
1782,33074913,Breastfeeding Monitoring Improves Maternal Self-Efficacy and Satisfaction.,"PURPOSE


The purpose of this study was to determine the effects of an interactive web-based breastfeeding monitoring system on breastfeeding self-efficacy and satisfaction among mothers of full-term infants at 1, 2, and 3 months after hospital discharge.
STUDY DESIGN


We conducted a secondary data analysis of our two-arm, repeated-measures randomized controlled trial that took place in three Midwestern hospitals. Participants were assigned to either control or intervention groups using random numbers. Of the 141 mother-baby dyads enrolled and randomized, 35 dropped out of the study, leaving 57 mothers in the control group and 49 in the intervention group. Mothers in both groups received care based on the hospital protocol, but mothers in the intervention group were also given access to an interactive web-based breastfeeding monitoring system prior to discharge. Participants were asked to enter breastfeeding data, receive educational messages for 30 days, and complete the Breastfeeding Self-Efficacy Scale (BFSE) at 1, 2, and 3 months and the Maternal Breastfeeding Evaluation Scale (MBFES) at 3 months. Mothers received feedback in case of breastfeeding problems.
RESULTS


A significant difference between groups in BFSE at the 2 and 3 months (p = 0.04; p = 0.04) with medium effect size (0.52, 0.53) was found. There was a significant difference between groups in the total score of MBFES (p = 0.02, effect size 0.53). Mean scores were 122.2, SD = 17.68 for intervention and 112.8, SD = 18.03 for control group. The MBFES scores were positively correlated to BFSE scores among intervention group at all time points (r = .714, n = 45, p < .00; r = .611, n = 41, p < .00; r = .637, n = 39, p < .00).
CLINICAL IMPLICATIONS


Interactive web-based breastfeeding monitoring improved maternal breastfeeding self-efficacy and satisfaction and may be a promising innovation to promote maternal breastfeeding self-efficacy and satisfaction.",2020,"There was a significant difference between groups in the total score of MBFES (p = 0.02, effect size 0.53).","['141 mother-baby dyads enrolled and randomized, 35 dropped out of the study, leaving 57 mothers in the control group and 49 in the intervention group', 'three Midwestern hospitals', 'mothers of full-term infants at 1, 2, and 3 months after hospital discharge']","['interactive web-based breastfeeding monitoring system', 'interactive web-based breastfeeding monitoring system prior to discharge']","['Maternal Breastfeeding Evaluation Scale (MBFES', 'BFSE', 'Mean scores', 'Breastfeeding Self-Efficacy Scale (BFSE', 'total score of MBFES', 'MBFES scores', 'BFSE scores', 'maternal breastfeeding self-efficacy and satisfaction', 'Maternal Self-Efficacy and Satisfaction', 'breastfeeding self-efficacy and satisfaction']","[{'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C4551581', 'cui_str': 'Term baby'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",,0.0609126,"There was a significant difference between groups in the total score of MBFES (p = 0.02, effect size 0.53).","[{'ForeName': 'Azza H', 'Initials': 'AH', 'LastName': 'Ahmed', 'Affiliation': 'Dr. Azza H. Ahmed is an Associate Professor, School of Nursing, Purdue University, West Lafayette, IN. Dr. Ahmed can be reached via email at ahmedah@purdue.edu Dr. Ali M. Roumani is an Assistant Professor, Department of Computer Science, Gulf University for Science & Technology, Mishref, Kuwait.'}, {'ForeName': 'Ali M', 'Initials': 'AM', 'LastName': 'Roumani', 'Affiliation': ''}]",MCN. The American journal of maternal child nursing,['10.1097/NMC.0000000000000658']
1783,33074940,Intravenously injected lidocaine or magnesium improves the quality of early recovery after laparoscopic cholecystectomy: A randomised controlled trial.,"BACKGROUND


Previous data show that lidocaine or magnesium has unique characteristics of stress inhibition and antiinflammation.
OBJECTIVE


We aimed to observe the effects of lidocaine or magnesium on the quality of recovery (QoR) after laparoscopic cholecystectomy.
DESIGN


Single-centre, prospective, randomised, double-blind study.
SETTING


The Affiliated Hospital of Xuzhou Medical University from March 2019 to October 2019.
PATIENTS


One hundred and fourteen patients scheduled for laparoscopic cholecystectomy.
INTERVENTION


The enrolled patients were randomly divided into three groups. Lidocaine (group L), magnesium sulphate (group M) or 0.9% saline (group C) was administered intravenously 10 min before induction.
MAIN OUTCOME MEASURES


The quality of recovery 15 (QoR-15) score, the Hospital Anxiety and Depression Scale (HADS), and the Numerical Rating Scale (NRS) score were selected. The usage of propofol and remifentanil, haemodynamic parameters, anaesthesia recovery parameters and adverse events were also evaluated.
RESULTS


The QoR-15 scores for group L (132.0) and group M (134.0) were 6 and 8 points higher than that of group C (126.0) on POD1 (postoperative day 1) (adjP < 0.05). However, the decrease of QoR-15 in Group L is less than the minimal clinically important difference (8).The NRS scores on POD1 in group C 3, were higher than other two groups (adjP < 0.05). The dosage of remifentanil in group L was lower than other two groups (adjP < 0.05).The physical independence of group L and group M and physical comfort of group M were improved compared with group C.
CONCLUSION


The results show that magnesium sulphate improved the QoR through improving physical comfort and physical independence in patients after laparoscopic cholecystectomy. However, lidocaine had limited effects on QoR under current conditions.
TRIAL REGISTRATION


ChiCTR1800019092 (www.chictr.org.cn).
CLINICAL TRIAL NUMBER AND REGISTRY URL


The study was registered in the Chinese Clinical Trials Register (ChiCTR1800019092) https://www.chictr.org.cn.",2020,The results show that magnesium sulphate improved the QoR through improving physical comfort and physical independence in patients after laparoscopic cholecystectomy.,"['patients after laparoscopic cholecystectomy', 'One hundred and fourteen patients scheduled for laparoscopic cholecystectomy', 'after laparoscopic cholecystectomy', 'The Affiliated Hospital of Xuzhou Medical University from March 2019 to October 2019']","['propofol and remifentanil', 'lidocaine', 'magnesium sulphate (group M) or 0.9% saline', 'magnesium sulphate', 'remifentanil', 'Lidocaine', 'lidocaine or magnesium']","['QoR-15', 'quality of early recovery', 'quality of recovery (QoR', 'physical comfort and physical independence', 'QoR-15 scores', 'quality of recovery 15 (QoR-15) score, the Hospital Anxiety and Depression Scale (HADS), and the Numerical Rating Scale (NRS) score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}, {'cui': 'C0441847', 'cui_str': 'Group M'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",114.0,0.0540343,The results show that magnesium sulphate improved the QoR through improving physical comfort and physical independence in patients after laparoscopic cholecystectomy.,"[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': ""From the The Yancheng Clinical College of Xuzhou Medical University, The First people's Hospital of Yancheng, Yancheng (JL, BQ), The Affiliated Hospital of Xuzhou Medical University (JL, QY, WC), Xuzhou Central Hospital (JFW) and the People's Hospital of Kizilsu Kirghiz Autonomous Prefecture, Xinjiang, PR China (CLG, WC).""}, {'ForeName': 'Jin-Feng', 'Initials': 'JF', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Chao-Lin', 'Initials': 'CL', 'LastName': 'Guo', 'Affiliation': ''}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Yin', 'Affiliation': ''}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Cheng', 'Affiliation': ''}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Qian', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001348']
1784,33074943,"Comparison of adequacy of anaesthesia monitoring with standard clinical practice monitoring during routine general anaesthesia: An international, multicentre, single-blinded randomised controlled trial.","BACKGROUND


Previous studies have suggested that monitoring the levels of both hypnosis and antinociception could reduce periods of inadequate anaesthesia. However, the evidence regarding associated benefits of this monitoring is still limited.
OBJECTIVE


The primary objective of this study was to confirm that guidance of anaesthesia by depth of hypnosis and antinociception monitoring decreases the number of inadequate anaesthesia events in comparison with standard clinical practice.
DESIGN


A multicentre, single-blinded, randomised controlled trial.
SETTING


The study was conducted in four European University hospitals in four different countries between December 2013 and November 2016.
PATIENTS


The study population consisted of a total of 494 adult patients undergoing elective surgery requiring tracheal intubation.
INTERVENTIONS


The patients were allocated to one of two groups. The first group was treated using Entropy for depth of hypnosis and surgical pleth index to determine depth of antinociception (adequacy of anaesthesia group; AoA group). The second group was monitored using standard monitoring alone (control group). Anaesthesia was conducted with target-controlled infusions of propofol and remifentanil.
MAIN OUTCOME MEASURES


The primary outcome of the study was the number of total unwanted events for example signs of inadequately light or unintentionally deep anaesthesia.
RESULTS


Evidence of inadequate anaesthesia had an incidence of around 0.7 events per patient in both groups with no difference between groups (P = 0.519). In the AoA group, the overall consumption of propofol was significantly reduced (6.9 vs. 7.5 mg kg h, P = 0.008) in comparison with the control group. The consumption of remifentanil was equal in both groups. The times to emergence [8.0 vs. 9.6 min (P = 0.005)] and full recovery in the postanaesthesia care unit (P = 0.043) were significantly shorter in the AoA group. No differences were seen in postoperative pain scores or in the use of analgesics.
CONCLUSION


In the current study, the guidance of total intravenous anaesthesia by Entropy and surgical pleth index in comparison with standard monitoring alone was not able to validate reduction of unwanted anaesthesia events. However, there was a reduction in the use of propofol, and shorter times for emergence and time spent in the postanaesthesia care unit.
TRIAL REGISTRATION


at ClinicalTrials.gov NCT01928875.",2020,The times to emergence [8.0 vs. 9.6 min (P = 0.005)] and full recovery in the postanaesthesia care unit (P = 0.043) were significantly shorter in the AoA group.,"['routine general anaesthesia', '494 adult patients undergoing elective surgery requiring tracheal intubation', 'four European University hospitals in four different countries between December 2013 and November 2016']","['propofol', 'propofol and remifentanil', 'anaesthesia monitoring with standard clinical practice monitoring']","['number of total unwanted events for example signs of inadequately light or unintentionally deep anaesthesia', 'overall consumption of propofol', 'consumption of remifentanil', 'postoperative pain scores', 'number of inadequate anaesthesia events']","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0454664', 'cui_str': 'Country'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0475747', 'cui_str': 'Deep anesthesia'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}]",494.0,0.101793,The times to emergence [8.0 vs. 9.6 min (P = 0.005)] and full recovery in the postanaesthesia care unit (P = 0.043) were significantly shorter in the AoA group.,"[{'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Gruenewald', 'Affiliation': 'From the Department of Anaesthesiology and Intensive Care Medicine, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany (MG, FR, BB), Department of Anaesthesiology, Tampere University Hospital, Tampere, Finland (JH, AY-H), Department of Anesthesiology, Amsterdam UMC, Location Academic Medical Center, Amsterdam, The Netherlands (BP, LK), Institute for Translational Medicine, Medical School, University of Pécs, Pécs, Hungary (ZM), Department of Anesthesiology and Intensive Therapy, Poznan University for Medical Sciences, Poznan, Poland (ZM), Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland (AY-H), Department of Anesthesiology and Intensive Therapy, University of Szeged, Szeged, Hungary (AO) and Department of Anaesthesiology and Intensive Care Medicine, Asklepios Hospital St. Georg, Hamburg, Germany (BB).'}, {'ForeName': 'Jarkko', 'Initials': 'J', 'LastName': 'Harju', 'Affiliation': 'From the Department of Anaesthesiology and Intensive Care Medicine, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany (MG, FR, BB), Department of Anaesthesiology, Tampere University Hospital, Tampere, Finland (JH, AY-H), Department of Anesthesiology, Amsterdam UMC, Location Academic Medical Center, Amsterdam, The Netherlands (BP, LK), Institute for Translational Medicine, Medical School, University of Pécs, Pécs, Hungary (ZM), Department of Anesthesiology and Intensive Therapy, Poznan University for Medical Sciences, Poznan, Poland (ZM), Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland (AY-H), Department of Anesthesiology and Intensive Therapy, University of Szeged, Szeged, Hungary (AO) and Department of Anaesthesiology and Intensive Care Medicine, Asklepios Hospital St. Georg, Hamburg, Germany (BB).'}, {'ForeName': 'Benedikt', 'Initials': 'B', 'LastName': 'Preckel', 'Affiliation': 'From the Department of Anaesthesiology and Intensive Care Medicine, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany (MG, FR, BB), Department of Anaesthesiology, Tampere University Hospital, Tampere, Finland (JH, AY-H), Department of Anesthesiology, Amsterdam UMC, Location Academic Medical Center, Amsterdam, The Netherlands (BP, LK), Institute for Translational Medicine, Medical School, University of Pécs, Pécs, Hungary (ZM), Department of Anesthesiology and Intensive Therapy, Poznan University for Medical Sciences, Poznan, Poland (ZM), Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland (AY-H), Department of Anesthesiology and Intensive Therapy, University of Szeged, Szeged, Hungary (AO) and Department of Anaesthesiology and Intensive Care Medicine, Asklepios Hospital St. Georg, Hamburg, Germany (BB).'}, {'ForeName': 'Zsolt', 'Initials': 'Z', 'LastName': 'Molnár', 'Affiliation': 'From the Department of Anaesthesiology and Intensive Care Medicine, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany (MG, FR, BB), Department of Anaesthesiology, Tampere University Hospital, Tampere, Finland (JH, AY-H), Department of Anesthesiology, Amsterdam UMC, Location Academic Medical Center, Amsterdam, The Netherlands (BP, LK), Institute for Translational Medicine, Medical School, University of Pécs, Pécs, Hungary (ZM), Department of Anesthesiology and Intensive Therapy, Poznan University for Medical Sciences, Poznan, Poland (ZM), Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland (AY-H), Department of Anesthesiology and Intensive Therapy, University of Szeged, Szeged, Hungary (AO) and Department of Anaesthesiology and Intensive Care Medicine, Asklepios Hospital St. Georg, Hamburg, Germany (BB).'}, {'ForeName': 'Arvi', 'Initials': 'A', 'LastName': 'Yli-Hankala', 'Affiliation': 'From the Department of Anaesthesiology and Intensive Care Medicine, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany (MG, FR, BB), Department of Anaesthesiology, Tampere University Hospital, Tampere, Finland (JH, AY-H), Department of Anesthesiology, Amsterdam UMC, Location Academic Medical Center, Amsterdam, The Netherlands (BP, LK), Institute for Translational Medicine, Medical School, University of Pécs, Pécs, Hungary (ZM), Department of Anesthesiology and Intensive Therapy, Poznan University for Medical Sciences, Poznan, Poland (ZM), Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland (AY-H), Department of Anesthesiology and Intensive Therapy, University of Szeged, Szeged, Hungary (AO) and Department of Anaesthesiology and Intensive Care Medicine, Asklepios Hospital St. Georg, Hamburg, Germany (BB).'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Rosskopf', 'Affiliation': 'From the Department of Anaesthesiology and Intensive Care Medicine, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany (MG, FR, BB), Department of Anaesthesiology, Tampere University Hospital, Tampere, Finland (JH, AY-H), Department of Anesthesiology, Amsterdam UMC, Location Academic Medical Center, Amsterdam, The Netherlands (BP, LK), Institute for Translational Medicine, Medical School, University of Pécs, Pécs, Hungary (ZM), Department of Anesthesiology and Intensive Therapy, Poznan University for Medical Sciences, Poznan, Poland (ZM), Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland (AY-H), Department of Anesthesiology and Intensive Therapy, University of Szeged, Szeged, Hungary (AO) and Department of Anaesthesiology and Intensive Care Medicine, Asklepios Hospital St. Georg, Hamburg, Germany (BB).'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Koers', 'Affiliation': 'From the Department of Anaesthesiology and Intensive Care Medicine, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany (MG, FR, BB), Department of Anaesthesiology, Tampere University Hospital, Tampere, Finland (JH, AY-H), Department of Anesthesiology, Amsterdam UMC, Location Academic Medical Center, Amsterdam, The Netherlands (BP, LK), Institute for Translational Medicine, Medical School, University of Pécs, Pécs, Hungary (ZM), Department of Anesthesiology and Intensive Therapy, Poznan University for Medical Sciences, Poznan, Poland (ZM), Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland (AY-H), Department of Anesthesiology and Intensive Therapy, University of Szeged, Szeged, Hungary (AO) and Department of Anaesthesiology and Intensive Care Medicine, Asklepios Hospital St. Georg, Hamburg, Germany (BB).'}, {'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'Orban', 'Affiliation': 'From the Department of Anaesthesiology and Intensive Care Medicine, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany (MG, FR, BB), Department of Anaesthesiology, Tampere University Hospital, Tampere, Finland (JH, AY-H), Department of Anesthesiology, Amsterdam UMC, Location Academic Medical Center, Amsterdam, The Netherlands (BP, LK), Institute for Translational Medicine, Medical School, University of Pécs, Pécs, Hungary (ZM), Department of Anesthesiology and Intensive Therapy, Poznan University for Medical Sciences, Poznan, Poland (ZM), Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland (AY-H), Department of Anesthesiology and Intensive Therapy, University of Szeged, Szeged, Hungary (AO) and Department of Anaesthesiology and Intensive Care Medicine, Asklepios Hospital St. Georg, Hamburg, Germany (BB).'}, {'ForeName': 'Berthold', 'Initials': 'B', 'LastName': 'Bein', 'Affiliation': 'From the Department of Anaesthesiology and Intensive Care Medicine, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany (MG, FR, BB), Department of Anaesthesiology, Tampere University Hospital, Tampere, Finland (JH, AY-H), Department of Anesthesiology, Amsterdam UMC, Location Academic Medical Center, Amsterdam, The Netherlands (BP, LK), Institute for Translational Medicine, Medical School, University of Pécs, Pécs, Hungary (ZM), Department of Anesthesiology and Intensive Therapy, Poznan University for Medical Sciences, Poznan, Poland (ZM), Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland (AY-H), Department of Anesthesiology and Intensive Therapy, University of Szeged, Szeged, Hungary (AO) and Department of Anaesthesiology and Intensive Care Medicine, Asklepios Hospital St. Georg, Hamburg, Germany (BB).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001357']
1785,33074950,Comparison of Right Colon Adenoma Miss Rates Between Water Exchange and Carbon Dioxide Insufflation: A Prospective Randomized Controlled Trial.,"GOALS


To test the hypothesis that water exchange (WE), when compared with carbon dioxide (CO2) insufflation, significantly reduces the right colon adenoma miss rate (rAMR) in a blinded randomized controlled trial with cap-assisted colonoscopy.
BACKGROUND


The unblinded consecutive group observational data showed that WE significantly decreased rAMR. The unblinded data are limited by potential bias.
STUDY


Consecutive patients aged 45 years or more were randomized to undergo insertion with WE or CO2. Withdrawal and polypectomy were performed with CO2 in both groups to the hepatic flexure. The colonoscope was reinserted to the cecum. A second colonoscopist re-examined the right colon. The second colonoscopist was unaware, but made a guess, of the initial insertion method. The number of additional adenomas divided by the total number detected in both examinations equaled rAMR.
RESULTS


Among 262 patients (131/group), demographic variables were similar. The body mass index was significantly higher in the WE group. Compared with CO2, WE significantly decreased rAMR [18.0% (33/183) vs. 34.6% (62/179), P=0.0025] and right colon serrated polyp miss rate [17.4% (27/155) vs. 39.3% (33/84), P=0.002]. Multivariate logistic regression analysis showed that WE was an independent predictor of rAMR (odds ratio, 0.42; 95% confidence interval, 0.21-0.86), and so was ≥2 adenomas in the right colon (odds ratio, 2.35; 95% confidence interval, 1.17-4.76). Whether the second colonoscopist guessed the insertion method correctly or not, and demographic and procedure variables were not associated with rAMR.
CONCLUSIONS


The randomized controlled trial validated unblinded observational data showing that WE significantly decreased rAMR and right colon serrated polyp miss rate (clinical trial registration number: NCT03845933).",2020,"Compared with CO2, WE significantly decreased rAMR [18.0% (33/183) vs. 34.6% (62/179), P=0.0025] and right colon serrated polyp miss rate [17.4% (27/155) vs. 39.3% (33/84), P=0.002].","['Consecutive patients aged 45 years or more', '262 patients (131/group']","['carbon dioxide (CO2) insufflation', 'Water Exchange and Carbon Dioxide Insufflation', 'CO2']","['body mass index', 'right colon serrated polyp miss rate', 'rAMR and right colon serrated polyp miss rate', 'right colon adenoma miss rate (rAMR', 'rAMR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0021634', 'cui_str': 'Insufflation'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1305188', 'cui_str': 'Right colon structure'}, {'cui': 'C3266123', 'cui_str': 'Serrated polyp'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}]",262.0,0.166332,"Compared with CO2, WE significantly decreased rAMR [18.0% (33/183) vs. 34.6% (62/179), P=0.0025] and right colon serrated polyp miss rate [17.4% (27/155) vs. 39.3% (33/84), P=0.002].","[{'ForeName': 'Chi-Liang', 'Initials': 'CL', 'LastName': 'Cheng', 'Affiliation': 'Department of Medicine, Evergreen General Hospital, Taoyuan.'}, {'ForeName': 'Yen-Lin', 'Initials': 'YL', 'LastName': 'Kuo', 'Affiliation': 'Department of Medicine, Evergreen General Hospital, Taoyuan.'}, {'ForeName': 'Yu-Hsi', 'Initials': 'YH', 'LastName': 'Hsieh', 'Affiliation': 'Division of Gastroenterology, Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Chiayi.'}, {'ForeName': 'Jui-Hsiang', 'Initials': 'JH', 'LastName': 'Tang', 'Affiliation': 'Department of Internal Medicine, Division of Gastroenterology and Hepatology, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Felix W', 'Initials': 'FW', 'LastName': 'Leung', 'Affiliation': 'Department of Medicine, Division of Gastroenterology, Sepulveda Ambulatory Care Center, Veterans Affairs Greater Los Angeles Healthcare System and David Geffen School of Medicine at UCLA, North Hills and Los Angeles, CA.'}]",Journal of clinical gastroenterology,['10.1097/MCG.0000000000001454']
1786,33075037,Cost Study of a Cluster Randomized Trial on a Clinical Decision Rule Guiding Antibiotic Treatment in Children With Suspected Lower Respiratory Tract Infections in the Emergency Department.,"BACKGROUND


Children with fever and respiratory symptoms represent a large patient group at the emergency department (ED). A decision rule-based treatment strategy improved targeting of antibiotics in these children in a recent clinical trial. This study aims to evaluate the impact of the decision rule on healthcare and societal costs, and to describe costs of children with suspected lower respiratory tract infections (RTIs) in the ED in general.
METHODS


In a stepped-wedge, cluster randomized trial, we collected cost data of children 1 month to 5 years of age with fever and cough/dyspnea in 8 EDs in The Netherlands (2016-2018). We calculated medical costs and societal costs per patient, during usual care (n = 597), and when antibiotic prescription was guided by the decision rule (n = 402). We calculated cost-of-illness of this patient group and estimated their annual costs at national level.
RESULTS


The cost-of-illness of children under 5 years with suspected lower RTIs in the ED was on average &OV0556;2130 per patient. At population level this is &OV0556;15 million per year in The Netherlands (&OV0556;1.7 million/100,000 children under 5). Mean costs per patient in usual care (&OV0556;2300) were reduced to &OV0556;1870 in the intervention phase (P = 0.01). Main cost drivers were hospitalization and lost parental workdays.
CONCLUSIONS


Implementation of a decision rule-based treatment strategy in children with suspected lower RTI was cost-saving, due to a reduction in hospitalization and parental absenteeism. Given the high frequency of this disease in children, the decision rule has the potential to result in a considerable cost reduction at population level.",2020,Mean costs per patient in usual care (&OV0556;2300) were reduced to &OV0556;1870 in the intervention phase (P = 0.01).,"['children with suspected lower RTI', 'Children With Suspected Lower Respiratory Tract Infections in the Emergency Department', 'children with suspected lower respiratory tract infections (RTIs) in the ED in general', 'Children with fever and respiratory symptoms represent a large patient group at the emergency department (ED', 'children 1 month to 5 years of age with fever and cough/dyspnea in 8 EDs in The Netherlands (2016-2018']",[],"['cost-of-illness', 'Mean costs per patient in usual care']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0035243', 'cui_str': 'Respiratory tract infection'}, {'cui': 'C0149725', 'cui_str': 'Lower respiratory tract infection'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0037090', 'cui_str': 'Respiratory symptom'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}]",[],"[{'cui': 'C0162698', 'cui_str': 'Cost of Sickness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",,0.0805656,Mean costs per patient in usual care (&OV0556;2300) were reduced to &OV0556;1870 in the intervention phase (P = 0.01).,"[{'ForeName': 'Josephine', 'Initials': 'J', 'LastName': 'van de Maat', 'Affiliation': ""From the Department of General Paediatrics, Erasmus MC - Sophia Children's Hospital, Rotterdam, The Netherlands.""}, {'ForeName': 'Michaël', 'Initials': 'M', 'LastName': 'van der Ven', 'Affiliation': 'Department of Pediatrics, Flevoziekenhuis, Almere, The Netherlands.'}, {'ForeName': 'Gertjan', 'Initials': 'G', 'LastName': 'Driessen', 'Affiliation': ""Department of Pediatrics, HAGA-Juliana Children's Hospital, Den Haag, The Netherlands.""}, {'ForeName': 'Anne-Marie', 'Initials': 'AM', 'LastName': 'van Wermeskerken', 'Affiliation': 'Department of Pediatrics, Flevoziekenhuis, Almere, The Netherlands.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Smit', 'Affiliation': 'Department of Pediatrics, Maasstad Ziekenhuis, Rotterdam, The Netherlands.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Noordzij', 'Affiliation': 'Department of Pediatrics, Reinier de Graaf Gasthuis, Delft, The Netherlands.'}, {'ForeName': 'Gerdien', 'Initials': 'G', 'LastName': 'Tramper-Stranders', 'Affiliation': 'Department of Pediatrics, Franciscus Gasthuis & Vlietland, Rotterdam, The Netherlands.'}, {'ForeName': 'Charlie', 'Initials': 'C', 'LastName': 'Obihara', 'Affiliation': 'Department of Pediatrics, Elisabeth Tweestedenziekenhuis, Tilburg, The Netherlands.'}, {'ForeName': 'Jeanine', 'Initials': 'J', 'LastName': 'Punt', 'Affiliation': 'Department of Pediatrics, Langeland Ziekenhuis, Zoetermeer, The Netherlands.'}, {'ForeName': 'Henriette', 'Initials': 'H', 'LastName': 'Moll', 'Affiliation': ""From the Department of General Paediatrics, Erasmus MC - Sophia Children's Hospital, Rotterdam, The Netherlands.""}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Polinder', 'Affiliation': 'Department of Public Health, Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'Rianne', 'Initials': 'R', 'LastName': 'Oostenbrink', 'Affiliation': ""From the Department of General Paediatrics, Erasmus MC - Sophia Children's Hospital, Rotterdam, The Netherlands.""}]",The Pediatric infectious disease journal,['10.1097/INF.0000000000002794']
1787,33075061,"Immune activation of Bio-Germanium in a randomized, double-blind, placebo-controlled clinical trial with 130 human subjects: Therapeutic opportunities from new insights.","REGISTERED CLINICAL TRIAL


[NCT03677921]; www.clinicaltrials.gov [KCT0002726]; https://cris.nih.go.kr.",2020,"REGISTERED CLINICAL TRIAL


[NCT03677921]; www.clinicaltrials.gov [KCT0002726]; https://cris.nih.go.kr.",['130 human subjects'],['placebo'],[],"[{'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0080105', 'cui_str': 'Human Subjects'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.631299,"REGISTERED CLINICAL TRIAL


[NCT03677921]; www.clinicaltrials.gov [KCT0002726]; https://cris.nih.go.kr.","[{'ForeName': 'Jung Min', 'Initials': 'JM', 'LastName': 'Cho', 'Affiliation': 'National Leading Research Laboratory of Clinical Nutrigenetics/Nutrigenomics, Department of Food and Nutrition, College of Human Ecology, Yonsei University, Seoul, Republic of Korea.'}, {'ForeName': 'Jisuk', 'Initials': 'J', 'LastName': 'Chae', 'Affiliation': 'National Leading Research Laboratory of Clinical Nutrigenetics/Nutrigenomics, Department of Food and Nutrition, College of Human Ecology, Yonsei University, Seoul, Republic of Korea.'}, {'ForeName': 'Sa Rang', 'Initials': 'SR', 'LastName': 'Jeong', 'Affiliation': 'National Leading Research Laboratory of Clinical Nutrigenetics/Nutrigenomics, Department of Food and Nutrition, College of Human Ecology, Yonsei University, Seoul, Republic of Korea.'}, {'ForeName': 'Min Jung', 'Initials': 'MJ', 'LastName': 'Moon', 'Affiliation': 'National Leading Research Laboratory of Clinical Nutrigenetics/Nutrigenomics, Department of Food and Nutrition, College of Human Ecology, Yonsei University, Seoul, Republic of Korea.'}, {'ForeName': 'Dong Yeob', 'Initials': 'DY', 'LastName': 'Shin', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jong Ho', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'National Leading Research Laboratory of Clinical Nutrigenetics/Nutrigenomics, Department of Food and Nutrition, College of Human Ecology, Yonsei University, Seoul, Republic of Korea.'}]",PloS one,['10.1371/journal.pone.0240358']
1788,33075160,Drugs for preventing postoperative nausea and vomiting in adults after general anaesthesia: a network meta-analysis.,"BACKGROUND


Postoperative nausea and vomiting (PONV) is a common adverse effect of anaesthesia and surgery. Up to 80% of patients may be affected. These outcomes are a major cause of patient dissatisfaction and may lead to prolonged hospital stay and higher costs of care along with more severe complications. Many antiemetic drugs are available for prophylaxis. They have various mechanisms of action and side effects, but there is still uncertainty about which drugs are most effective with the fewest side effects.
OBJECTIVES


• To compare the efficacy and safety of different prophylactic pharmacologic interventions (antiemetic drugs) against no treatment, against placebo, or against each other (as monotherapy or combination prophylaxis) for prevention of postoperative nausea and vomiting in adults undergoing any type of surgery under general anaesthesia • To generate a clinically useful ranking of antiemetic drugs (monotherapy and combination prophylaxis) based on efficacy and safety • To identify the best dose or dose range of antiemetic drugs in terms of efficacy and safety SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP), ClinicalTrials.gov, and reference lists of relevant systematic reviews. The first search was performed in November 2017 and was updated in April 2020. In the update of the search, 39 eligible studies were found that were not included in the analysis (listed as awaiting classification).
SELECTION CRITERIA


Randomized controlled trials (RCTs) comparing effectiveness or side effects of single antiemetic drugs in any dose or combination against each other or against an inactive control in adults undergoing any type of surgery under general anaesthesia. All antiemetic drugs belonged to one of the following substance classes: 5-HT₃ receptor antagonists, D₂ receptor antagonists, NK₁ receptor antagonists, corticosteroids, antihistamines, and anticholinergics. No language restrictions were applied. Abstract publications were excluded.
DATA COLLECTION AND ANALYSIS


A review team of 11 authors independently assessed trials for inclusion and risk of bias and subsequently extracted data. We performed pair-wise meta-analyses for drugs of direct interest (amisulpride, aprepitant, casopitant, dexamethasone, dimenhydrinate, dolasetron, droperidol, fosaprepitant, granisetron, haloperidol, meclizine, methylprednisolone, metoclopramide, ondansetron, palonosetron, perphenazine, promethazine, ramosetron, rolapitant, scopolamine, and tropisetron) compared to placebo (inactive control). We performed network meta-analyses (NMAs) to estimate the relative effects and ranking (with placebo as reference) of all available single drugs and combinations. Primary outcomes were vomiting within 24 hours postoperatively, serious adverse events (SAEs), and any adverse event (AE). Secondary outcomes were drug class-specific side effects (e.g. headache), mortality, early and late vomiting, nausea, and complete response. We performed subgroup network meta-analysis with dose of drugs as a moderator variable using dose ranges based on previous consensus recommendations. We assessed certainty of evidence of NMA treatment effects for all primary outcomes and drug class-specific side effects according to GRADE (CINeMA, Confidence in Network Meta-Analysis). We restricted GRADE assessment to single drugs of direct interest compared to placebo.
MAIN RESULTS


We included 585 studies (97,516 randomized participants). Most of these studies were small (median sample size of 100); they were published between 1965 and 2017 and were primarily conducted in Asia (51%), Europe (25%), and North America (16%). Mean age of the overall population was 42 years. Most participants were women (83%), had American Society of Anesthesiologists (ASA) physical status I and II (70%), received perioperative opioids (88%), and underwent gynaecologic (32%) or gastrointestinal surgery (19%) under general anaesthesia using volatile anaesthetics (88%). In this review, 44 single drugs and 51 drug combinations were compared. Most studies investigated only single drugs (72%) and included an inactive control arm (66%). The three most investigated single drugs in this review were ondansetron (246 studies), dexamethasone (120 studies), and droperidol (97 studies). Almost all studies (89%) reported at least one efficacy outcome relevant for this review. However, only 56% reported at least one relevant safety outcome. Altogether, 157 studies (27%) were assessed as having overall low risk of bias, 101 studies (17%) overall high risk of bias, and 327 studies (56%) overall unclear risk of bias. Vomiting within 24 hours postoperatively Relative effects from NMA for vomiting within 24 hours (282 RCTs, 50,812 participants, 28 single drugs, and 36 drug combinations) suggest that 29 out of 36 drug combinations and 10 out of 28 single drugs showed a clinically important benefit (defined as the upper end of the 95% confidence interval (CI) below a risk ratio (RR) of 0.8) compared to placebo. Combinations of drugs were generally more effective than single drugs in preventing vomiting. However, single NK₁ receptor antagonists showed treatment effects similar to most of the drug combinations. High-certainty evidence suggests that the following single drugs reduce vomiting (ordered by decreasing efficacy): aprepitant (RR 0.26, 95% CI 0.18 to 0.38, high certainty, rank 3/28 of single drugs); ramosetron (RR 0.44, 95% CI 0.32 to 0.59, high certainty, rank 5/28); granisetron (RR 0.45, 95% CI 0.38 to 0.54, high certainty, rank 6/28); dexamethasone (RR 0.51, 95% CI 0.44 to 0.57, high certainty, rank 8/28); and ondansetron (RR 0.55, 95% CI 0.51 to 0.60, high certainty, rank 13/28). Moderate-certainty evidence suggests that the following single drugs probably reduce vomiting: fosaprepitant (RR 0.06, 95% CI 0.02 to 0.21, moderate certainty, rank 1/28) and droperidol (RR 0.61, 95% CI 0.54 to 0.69, moderate certainty, rank 20/28). Recommended and high doses of granisetron, dexamethasone, ondansetron, and droperidol showed clinically important benefit, but low doses showed no clinically important benefit. Aprepitant was used mainly at high doses, ramosetron at recommended doses, and fosaprepitant at doses of 150 mg (with no dose recommendation available). Frequency of SAEs Twenty-eight RCTs were included in the NMA for SAEs (10,766 participants, 13 single drugs, and eight drug combinations). The certainty of evidence for SAEs when using one of the best and most reliable anti-vomiting drugs (aprepitant, ramosetron, granisetron, dexamethasone, ondansetron, and droperidol compared to placebo) ranged from very low to low. Droperidol (RR 0.88, 95% CI 0.08 to 9.71, low certainty, rank 6/13) may reduce SAEs. We are uncertain about the effects of aprepitant (RR 1.39, 95% CI 0.26 to 7.36, very low certainty, rank 11/13), ramosetron (RR 0.89, 95% CI 0.05 to 15.74, very low certainty, rank 7/13), granisetron (RR 1.21, 95% CI 0.11 to 13.15, very low certainty, rank 10/13), dexamethasone (RR 1.16, 95% CI 0.28 to 4.85, very low certainty, rank 9/13), and ondansetron (RR 1.62, 95% CI 0.32 to 8.10, very low certainty, rank 12/13). No studies reporting SAEs were available for fosaprepitant. Frequency of any AE Sixty-one RCTs were included in the NMA for any AE (19,423 participants, 15 single drugs, and 11 drug combinations). The certainty of evidence for any AE when using one of the best and most reliable anti-vomiting drugs (aprepitant, ramosetron, granisetron, dexamethasone, ondansetron, and droperidol compared to placebo) ranged from very low to moderate. Granisetron (RR 0.92, 95% CI 0.80 to 1.05, moderate certainty, rank 7/15) probably has no or little effect on any AE. Dexamethasone (RR 0.77, 95% CI 0.55 to 1.08, low certainty, rank 2/15) and droperidol (RR 0.89, 95% CI 0.81 to 0.98, low certainty, rank 6/15) may reduce any AE. Ondansetron (RR 0.95, 95% CI 0.88 to 1.01, low certainty, rank 9/15) may have little or no effect on any AE. We are uncertain about the effects of aprepitant (RR 0.87, 95% CI 0.78 to 0.97, very low certainty, rank 3/15) and ramosetron (RR 1.00, 95% CI 0.65 to 1.54, very low certainty, rank 11/15) on any AE. No studies reporting any AE were available for fosaprepitant. Class-specific side effects For class-specific side effects (headache, constipation, wound infection, extrapyramidal symptoms, sedation, arrhythmia, and QT prolongation) of relevant substances, the certainty of evidence for the best and most reliable anti-vomiting drugs mostly ranged from very low to low. Exceptions were that ondansetron probably increases headache (RR 1.16, 95% CI 1.06 to 1.28, moderate certainty, rank 18/23) and probably reduces sedation (RR 0.87, 95% CI 0.79 to 0.96, moderate certainty, rank 5/24) compared to placebo. The latter effect is limited to recommended and high doses of ondansetron. Droperidol probably reduces headache (RR 0.76, 95% CI 0.67 to 0.86, moderate certainty, rank 5/23) compared to placebo. We have high-certainty evidence that dexamethasone (RR 1.00, 95% CI 0.91 to 1.09, high certainty, rank 16/24) has no effect on sedation compared to placebo. No studies assessed substance class-specific side effects for fosaprepitant. Direction and magnitude of network effect estimates together with level of evidence certainty are graphically summarized for all pre-defined GRADE-relevant outcomes and all drugs of direct interest compared to placebo in http://doi.org/10.5281/zenodo.4066353.
AUTHORS' CONCLUSIONS


We found high-certainty evidence that five single drugs (aprepitant, ramosetron, granisetron, dexamethasone, and ondansetron) reduce vomiting, and moderate-certainty evidence that two other single drugs (fosaprepitant and droperidol) probably reduce vomiting, compared to placebo. Four of the six substance classes (5-HT₃ receptor antagonists, D₂ receptor antagonists, NK₁ receptor antagonists, and corticosteroids) were thus represented by at least one drug with important benefit for prevention of vomiting. Combinations of drugs were generally more effective than the corresponding single drugs in preventing vomiting. NK₁ receptor antagonists were the most effective drug class and had comparable efficacy to most of the drug combinations. 5-HT₃ receptor antagonists were the best studied substance class. For most of the single drugs of direct interest, we found only very low to low certainty evidence for safety outcomes such as occurrence of SAEs, any AE, and substance class-specific side effects. Recommended and high doses of granisetron, dexamethasone, ondansetron, and droperidol were more effective than low doses for prevention of vomiting. Dose dependency of side effects was rarely found due to the limited number of studies, except for the less sedating effect of recommended and high doses of ondansetron. The results of the review are transferable mainly to patients at higher risk of nausea and vomiting (i.e. healthy women undergoing inhalational anaesthesia and receiving perioperative opioids). Overall study quality was limited, but certainty assessments of effect estimates consider this limitation. No further efficacy studies are needed as there is evidence of moderate to high certainty for seven single drugs with relevant benefit for prevention of vomiting. However, additional studies are needed to investigate potential side effects of these drugs and to examine higher-risk patient populations (e.g. individuals with diabetes and heart disease).",2020,"Droperidol probably reduces headache (RR 0.76, 95% CI 0.67 to 0.86, moderate certainty, rank 5/23) compared to placebo.","['585 studies (97,516 randomized participants', 'small (median sample size of 100); they were published between 1965 and 2017 and were primarily conducted in Asia (51%), Europe (25%), and North America (16', 'adults undergoing any type of surgery under general anaesthesia', 'adults after general anaesthesia', 'Frequency of any AE Sixty-one RCTs were included in the NMA for any AE (19,423 participants, 15 single drugs, and 11 drug combinations', '39 eligible studies were found that were not included in the analysis (listed as awaiting classification', 'healthy women undergoing inhalational anaesthesia and receiving perioperative opioids', 'adults undergoing any type of surgery under general anaesthesia •', 'Most participants were women (83%), had American Society of Anesthesiologists (ASA) physical status']","['placebo (inactive control', 'granisetron', 'Dexamethasone', 'perioperative opioids', 'droperidol', 'gastrointestinal surgery (19%) under general anaesthesia using volatile anaesthetics', 'dexamethasone', 'placebo', 'Granisetron', 'direct interest (amisulpride, aprepitant, casopitant, dexamethasone, dimenhydrinate, dolasetron, droperidol, fosaprepitant, granisetron, haloperidol, meclizine, methylprednisolone, metoclopramide, ondansetron, palonosetron, perphenazine, promethazine, ramosetron, rolapitant, scopolamine, and tropisetron', 'antiemetic drugs (monotherapy and combination prophylaxis', 'Droperidol', 'ramosetron, granisetron, dexamethasone, ondansetron, and droperidol', 'placebo, or against each other (as monotherapy or combination prophylaxis', 'prophylactic pharmacologic interventions (antiemetic drugs', 'ramosetron', 'NMA', 'Ondansetron', 'ramosetron, granisetron, dexamethasone, and ondansetron', 'ondansetron', 'granisetron, dexamethasone, ondansetron, and droperidol']","['reduce SAEs', 'headache', 'Vomiting', 'postoperative nausea and vomiting', 'vomiting within 24 hours postoperatively, serious adverse events (SAEs), and any adverse event (AE', 'efficacy and safety', 'nausea and vomiting', 'sedation', 'drug class-specific side effects (e.g. headache), mortality, early and late vomiting, nausea, and complete response', 'vomiting', 'efficacy and safety •', 'headache, constipation, wound infection, extrapyramidal symptoms, sedation, arrhythmia, and QT prolongation']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4517832', 'cui_str': '61'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0069477', 'cui_str': 'NG-Monomethyl-L-Arginine'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0013162', 'cui_str': 'Drug Combinations'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0061863', 'cui_str': 'Granisetron'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0013136', 'cui_str': 'Droperidol'}, {'cui': 'C0524722', 'cui_str': 'Gastrointestinal surgery'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0443769', 'cui_str': 'Volatile agent'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0103045', 'cui_str': 'Amisulpride'}, {'cui': 'C1176306', 'cui_str': 'aprepitant'}, {'cui': 'C2347566', 'cui_str': 'casopitant'}, {'cui': 'C0012381', 'cui_str': 'Dimenhydrinate'}, {'cui': 'C0209210', 'cui_str': 'Dolasetron'}, {'cui': 'C2349941', 'cui_str': 'fosaprepitant'}, {'cui': 'C0018546', 'cui_str': 'Haloperidol'}, {'cui': 'C0025039', 'cui_str': 'Meclizine'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0025853', 'cui_str': 'Metoclopramide'}, {'cui': 'C0061851', 'cui_str': 'Ondansetron'}, {'cui': 'C0220578', 'cui_str': 'palonosetron'}, {'cui': 'C0031184', 'cui_str': 'Perphenazine'}, {'cui': 'C0033405', 'cui_str': 'Promethazine'}, {'cui': 'C0526950', 'cui_str': 'ramosetron'}, {'cui': 'C3273719', 'cui_str': 'rolapitant'}, {'cui': 'C0036442', 'cui_str': 'Scopolamine'}, {'cui': 'C0063322', 'cui_str': 'tropisetron'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic agent'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0069477', 'cui_str': 'NG-Monomethyl-L-Arginine'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0043241', 'cui_str': 'Local infection of wound'}, {'cui': 'C0234133', 'cui_str': 'Extrapyramidal sign'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0151878', 'cui_str': 'Prolonged QT interval'}]",97516.0,0.375643,"Droperidol probably reduces headache (RR 0.76, 95% CI 0.67 to 0.86, moderate certainty, rank 5/23) compared to placebo.","[{'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Weibel', 'Affiliation': 'Department of Anesthesiology and Critical Care, University Hospital Wuerzburg, Wuerzburg, Germany.'}, {'ForeName': 'Gerta', 'Initials': 'G', 'LastName': 'Rücker', 'Affiliation': 'Institute of Medical Biometry and Statistics, Faculty of Medicine and Medical Center - University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Leopold Hj', 'Initials': 'LH', 'LastName': 'Eberhart', 'Affiliation': 'Department of Anaesthesiology & Intensive Care Medicine, Philipps-University Marburg, Marburg, Germany.'}, {'ForeName': 'Nathan L', 'Initials': 'NL', 'LastName': 'Pace', 'Affiliation': 'Department of Anesthesiology, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Hannah M', 'Initials': 'HM', 'LastName': 'Hartl', 'Affiliation': 'Department of Anesthesiology and Critical Care, University Hospital Wuerzburg, Wuerzburg, Germany.'}, {'ForeName': 'Olivia L', 'Initials': 'OL', 'LastName': 'Jordan', 'Affiliation': 'Department of Anesthesiology and Critical Care, University Hospital Wuerzburg, Wuerzburg, Germany.'}, {'ForeName': 'Debora', 'Initials': 'D', 'LastName': 'Mayer', 'Affiliation': 'Department of Anesthesiology and Critical Care, University Hospital Wuerzburg, Wuerzburg, Germany.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Riemer', 'Affiliation': 'Department of Anesthesiology and Critical Care, University Hospital Wuerzburg, Wuerzburg, Germany.'}, {'ForeName': 'Maximilian S', 'Initials': 'MS', 'LastName': 'Schaefer', 'Affiliation': 'Department of Anaesthesiology, University Hospital Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Raj', 'Affiliation': 'Department of Anaesthesia, Intensive Care Medicine and Pain Medicine, Queen Elizabeth University Hospital, Glasgow, UK.'}, {'ForeName': 'Insa', 'Initials': 'I', 'LastName': 'Backhaus', 'Affiliation': 'Department of Public Health and Infectious Diseases, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Helf', 'Affiliation': 'Department of Anesthesiology and Critical Care, University Hospital Wuerzburg, Wuerzburg, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Schlesinger', 'Affiliation': 'Department of Anesthesiology and Critical Care, University Hospital Wuerzburg, Wuerzburg, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Kienbaum', 'Affiliation': 'Department of Anaesthesiology, University Hospital Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Kranke', 'Affiliation': 'Department of Anesthesiology and Critical Care, University Hospital Wuerzburg, Wuerzburg, Germany.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD012859.pub2']
1789,33075170,"A Phase I Trial of the Safety, Tolerability, and Pharmacokinetics of Cannabidiol Administered as Single-dose Oil Solution and Single and Multiple doses of a Sublingual Wafer in Healthy Volunteers.","AIMS


This study investigated the safety, tolerability, and PK after administration of a specific Cannabis sativa cultivar extract, standardised to CBD content as sublingual wafer or oil formulation compared to nabiximols oromucosal spray.
METHODS


For the single-dose study, the design was an open-label, four-way crossover in 12 healthy volunteers randomised to receive a sequence of four different single doses of CBD as a sublingual wafer (25 or 50 mg CBD), oil solution (50 mg CBD), or nabiximols oromucosal spray (20 mg CBD, 21.6 mg THC). For the multiple-dose study, sublingual wafer (50 mg CBD) was administered twice a day for five days.
RESULTS


The extract was generally well tolerated by participants when administered in either wafer or oil form, with some adverse events, including mild or moderate somnolence, sedation and altered mood. The relative bioavailability of CBD after administration as a sublingual wafer was comparable with that of oil solution with 90% confidence interval of 83-131%. The median maximum concentrations of CBD after administration of oil solution and wafer was 9.4 and 11.9 ng mL -1  , respectively. Maximum concentrations of CBD occurred 4 hours after administration, with an estimated terminal elimination half-life of 6 hours. There was no statistically significant difference between the AUC 0-t  of CBD after administration of oil solution or wafer compared with nabiximols oromucosal spray.
CONCLUSION


Oil solution and sublingual wafer formulations of the extract standardised with CBD were well tolerated and achieved equivalent concentrations of CBD when compared to an available commercial nabiximols formulation.",2020,"There was no statistically significant difference between the AUC 0-t  of CBD after administration of oil solution or wafer compared with nabiximols oromucosal spray.
","['12 healthy volunteers', 'Healthy Volunteers']","['oil solution (50 mg CBD), or nabiximols oromucosal spray', 'oil solution', 'Oil solution', 'CBD']","['relative bioavailability of CBD', 'Safety, Tolerability, and Pharmacokinetics', 'median maximum concentrations of CBD', 'Maximum concentrations of CBD', 'tolerated and achieved equivalent concentrations of CBD', 'mild or moderate somnolence, sedation and altered mood', 'safety, tolerability, and PK']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0006863', 'cui_str': 'Cannabidiol'}, {'cui': 'C2347556', 'cui_str': 'nabiximols'}, {'cui': 'C1273657', 'cui_str': 'Oromucosal spray'}]","[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0006863', 'cui_str': 'Cannabidiol'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0085633', 'cui_str': 'Mood swings'}]",12.0,0.080618,"There was no statistically significant difference between the AUC 0-t  of CBD after administration of oil solution or wafer compared with nabiximols oromucosal spray.
","[{'ForeName': 'Adele', 'Initials': 'A', 'LastName': 'Hosseini', 'Affiliation': 'BOD Australia Pty Ltd, Sydney, Australia.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'McLachlan', 'Affiliation': 'Sydney Pharmacy School, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Jason D', 'Initials': 'JD', 'LastName': 'Lickliter', 'Affiliation': 'Nucleus Network Pty Ltd, Melbourne, Australia.'}]",British journal of clinical pharmacology,['10.1111/bcp.14617']
1790,33075179,Randomized Control Trial of Oral Arginine Therapy for Children with Sickle Cell Anemia Hospitalized for Pain in Nigeria.,"Low arginine bioavailability is associated with vaso-occlusive painful crisis (VOC) severity in sickle cell anemia (SCA) and predicts need for pediatric hospitalization. Intravenous arginine therapy has opioid-sparing effects and was found to significantly decrease pain scores in children hospitalized with SCA-VOC in a phase-2 randomized placebo-controlled trial (RCT). Efficacy of oral arginine is unknown. Our objective was to determine the safety and efficacy of oral arginine therapy in Nigerian children with SCA. A double-blind RCT of oral  L  -arginine-hydrochloride (100mg/kg TID) was conducted in children with SCA-VOC, aged 5-17 years, hospitalized at 2 Nigerian sites. The primary outcome measure was analgesic usage, quantified by difference in the mean Analgesic Medication Quantification Scale (MQS). Secondary outcomes included daily pain scores, time-to-crisis-resolution and length-of-hospital-stay. An intention-to-treat analysis was performed. Sixty-eight children (age 5-17years, mean 10.6±0.4 years; 56% male), were randomized to receive  L  -arginine (35 patients) or placebo (33 patients). The mean total MQS for the arginine group was 73.4 [95% CI, 62.4-84.3] versus 120.0 [96.7-143.3] for placebo (p<0.001). The mean rate of decline in worst pain scores was faster in the arginine arm versus placebo (1.50 [1.23-1.77] vs. 1.09 [0.94-1.24] point/day, p=0.009). Children receiving arginine had a shorter time-to-crisis-resolution (p=0.02), shorter hospital-stay (p=0.002) and experienced no serious adverse event. Pain control was more rapid, total analgesic requirement was significantly reduced, and most notably, time-to-crisis-resolution and length-of-hospital-stay were shorter in children with SCA-VOC receiving arginine versus placebo. Given the established safety and low cost, oral arginine is a promising adjuvant therapy for SCA-VOC management. This article is protected by copyright. All rights reserved.",2020,"Children receiving arginine had a shorter time-to-crisis-resolution (p=0.02), shorter hospital-stay (p=0.002) and experienced no serious adverse event.","['mean 10.6±0.4\u2009years; 56% male', 'children with SCA-VOC, aged 5-17\u2009years, hospitalized at 2 Nigerian sites', 'Nigerian children with SCA', 'Sixty-eight children (age 5-17years', 'sickle cell anemia (SCA', 'Children with Sickle Cell Anemia Hospitalized for Pain in Nigeria', 'children hospitalized with SCA-VOC']","['oral arginine therapy', 'Intravenous arginine therapy', 'oral arginine', 'oral  L  -arginine-hydrochloride', 'Oral Arginine Therapy', 'placebo', 'L  -arginine']","['Pain control', 'mean total MQS', 'total analgesic requirement', 'analgesic usage, quantified by difference in the mean Analgesic Medication Quantification Scale (MQS', 'safety and efficacy', 'shorter time-to-crisis-resolution', 'shorter hospital-stay', 'pain scores', 'time-to-crisis-resolution and length-of-hospital-stay', 'mean rate of decline in worst pain scores', 'daily pain scores, time-to-crisis-resolution and length-of-hospital-stay']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0002895', 'cui_str': 'Sickling disorder due to hemoglobin S'}, {'cui': 'C1947917', 'cui_str': 'Occluded'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231224', 'cui_str': 'Crisis'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C1556089', 'cui_str': 'Nigerians'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0450387', 'cui_str': '68'}, {'cui': 'C0028075', 'cui_str': 'Nigeria'}, {'cui': 'C0008098', 'cui_str': 'Children, Hospitalized'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0231224', 'cui_str': 'Crisis'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",68.0,0.351062,"Children receiving arginine had a shorter time-to-crisis-resolution (p=0.02), shorter hospital-stay (p=0.002) and experienced no serious adverse event.","[{'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Onalo', 'Affiliation': 'Department of Paediatrics, Faculty of Clinical Sciences, University of Abuja, Nigeria.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Cooper', 'Affiliation': 'Department of Paediatrics, Faculty of Clinical Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Antoinette', 'Initials': 'A', 'LastName': 'Cilliers', 'Affiliation': 'Department of Paediatrics, Chris Hani Baragwanath Academic Hospital, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Barend C', 'Initials': 'BC', 'LastName': 'Vorster', 'Affiliation': 'Centre for Human Metabolomics, North West University, Potchefstroom, South Africa.'}, {'ForeName': 'Nnebe-Agumadu', 'Initials': 'NA', 'LastName': 'Uche', 'Affiliation': 'Department of Paediatrics, Faculty of Clinical Sciences, University of Abuja, Nigeria.'}, {'ForeName': 'Oniyangi O', 'Initials': 'OO', 'LastName': 'Oluseyi', 'Affiliation': 'Abuja.'}, {'ForeName': 'Victoria D', 'Initials': 'VD', 'LastName': 'Onalo', 'Affiliation': 'Emergency Paediatric Pharmacy, University of Abuja Teaching Hospital, Abuja.'}, {'ForeName': 'Yunusa', 'Initials': 'Y', 'LastName': 'Zubairu', 'Affiliation': 'Emergency Paediatric Pharmacy, University of Abuja Teaching Hospital, Abuja.'}, {'ForeName': 'Alice U', 'Initials': 'AU', 'LastName': 'Ayodele-Kehinde', 'Affiliation': 'Department of Pharmacy, University of Abuja Teaching Hospital, Abuja.'}, {'ForeName': 'Oladimeji M', 'Initials': 'OM', 'LastName': 'Damilare', 'Affiliation': 'Biostatistician, Independent Consultant.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Figueroa', 'Affiliation': 'Department of Pediatrics, Biostatistical Core, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Claudia R', 'Initials': 'CR', 'LastName': 'Morris', 'Affiliation': 'Department of Pediatrics, Division of Pediatric Emergency Medicine, Emory University School of Medicine, Atlanta, Georgia, USA.'}]",American journal of hematology,['10.1002/ajh.26028']
1791,33075192,"Pelvic floor morphometrical and functional changes immediately after pelvic floor muscle training and at 1-year follow-up, in older incontinent women.","AIMS


To compare the effects of group-based and individual physiotherapy for stress or mixed urinary incontinence (UI) on pelvic floor morphometry, pelvic floor muscle (PFM) function, and related self-efficacy, immediately after treatment and at 1 year.
METHODS


This is a planned secondary analysis of the group rehabilitation or individual physiotherapy study, an assessor-blinded, randomized, noninferiority trial. Eligible participants included 362 community-dwelling older women with symptoms of stress/mixed UI. After learning how to contract PFMs, participants completed 12 weeks of PFM training, either individually (one-on-one) or as part of a group (eight women). Pelvic floor transperineal ultrasound volumes (morphometry), PFM intravaginal dynamometric data (function), and self-efficacy in performing PFM exercises were acquired at baseline, posttreatment, and at 1 year.
RESULTS


Groups were comparable at all time points. Immediately posttreatment, both groups demonstrated significant changes in pelvic floor morphometry during coughs, and in PFM function during contractions and coughs. Participants also reported improved self-efficacy in performing PFM exercises. Results were sustained at 1 year. When participants coughed, pelvic floor structures were better supported (reflected by less caudal movement of the puborectalis sling and a smaller opening of the levator hiatus) in a pattern consistent with the ""knack"" strategy. Furthermore, both interventions resulted in stronger, faster, more coordinated, and more endurant PFMs.
CONCLUSION


In older women with stress or mixed UI, both individual and group-based PFM training resulted in comparable improvements in overall PFM function, pelvic floor morphometry during coughs, and related self-efficacy in performing PFM exercises, which were sustained at 1 year.",2020,"Immediately posttreatment, both groups demonstrated significant changes in pelvic floor morphometry during coughs, and in PFM function during contractions and coughs.","['Eligible participants included 362 community-dwelling older women with symptoms of stress/mixed UI', 'older incontinent women', 'older women with stress or mixed UI']","['group-based and individual physiotherapy', 'pelvic floor muscle training', 'PFM training']","['Pelvic floor transperineal ultrasound volumes (morphometry), PFM intravaginal dynamometric data (function), and self-efficacy', 'PFM function', 'overall PFM function, pelvic floor morphometry during coughs, and related self-efficacy', 'stress or mixed urinary incontinence (UI) on pelvic floor morphometry, pelvic floor muscle (PFM) function, and related self-efficacy', 'pelvic floor morphometry', 'self-efficacy']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0521991', 'cui_str': 'Symptoms of stress'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C0231238', 'cui_str': 'Incontinent'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0869256', 'cui_str': 'Mixed urinary incontinence'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}]","[{'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0205500', 'cui_str': 'Perineal approach'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0442122', 'cui_str': 'Intravaginal'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0231484', 'cui_str': 'Muscle function'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0200760', 'cui_str': 'Morphometric analysis'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0869256', 'cui_str': 'Mixed urinary incontinence'}, {'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",362.0,0.0374342,"Immediately posttreatment, both groups demonstrated significant changes in pelvic floor morphometry during coughs, and in PFM function during contractions and coughs.","[{'ForeName': 'Licia P', 'Initials': 'LP', 'LastName': 'Cacciari', 'Affiliation': 'School of Rehabilitation, Faculty of Medicine, Université de Montréal and Research Center of the Institut Universitaire de Gériatrie de Montréal, Montréal, Québec, Canada.'}, {'ForeName': 'Mélanie', 'Initials': 'M', 'LastName': 'Morin', 'Affiliation': ""School of Rehabilitation, Faculty of Medicine and Health Sciences, Université de Sherbrooke, Research Center of the Centre Hospitalier de l'Université de Sherbrooke, Sherbrooke, Québec, Canada.""}, {'ForeName': 'Marie-Hélène', 'Initials': 'MH', 'LastName': 'Mayrand', 'Affiliation': ""Departments of Obstetrics and Gynecology and Social and Preventive Medicine, Université de Montréal and Research Center of the Centre hospitalier de l'Université de Montréal, Montréal, Québec, Canada.""}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Tousignant', 'Affiliation': ""School of Rehabilitation, Faculty of Medicine and Health Sciences, Université de Sherbrooke, Research Center of the Centre Hospitalier de l'Université de Sherbrooke, Sherbrooke, Québec, Canada.""}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Abrahamowicz', 'Affiliation': 'Department of Epidemiology, Biostatistics, and Occupational Health, McGill University and Research Institute of the McGill University Health Center, Montreal, Québec, Canada.'}, {'ForeName': 'Chantale', 'Initials': 'C', 'LastName': 'Dumoulin', 'Affiliation': 'School of Rehabilitation, Faculty of Medicine, Université de Montréal and Research Center of the Institut Universitaire de Gériatrie de Montréal, Montréal, Québec, Canada.'}]",Neurourology and urodynamics,['10.1002/nau.24542']
1792,33083644,Quantitative 3-Dimensional Photographic Assessment of Breast Cosmesis After Whole Breast Irradiation for Early Stage Breast Cancer: A Secondary Analysis of a Randomized Clinical Trial.,"Purpose


Our purpose was to use 3-dimensional (3D) surface photography to quantitatively measure breast cosmesis within the framework of a randomized clinical trial of conventionally fractionated (CF) and hypofractionated (HF) whole breast irradiation (WBI); to identify how 3D measurements are associated with patient- and physician-reported cosmesis; and to determine whether objective measures of breast symmetry varied by WBI treatment arm or transforming growth factor β 1 ( TGFβ1 ) status.
Methods and Materials


From 2011 to 2014, 287 women age ≥40 with ductal carcinoma in situ or early-stage invasive breast cancer were enrolled in a multicenter trial and randomized to HF-WBI or CF-WBI with a boost. Three-dimensional surface photography was performed at 3 years posttreatment. Patient-reported cosmetic outcomes were recorded with the Breast Cancer Treatment Outcome Scale. Physician-reported cosmetic outcomes were assessed by the Radiation Therapy Oncology Group scale. Volume ratios and 6 quantitative measures of breast symmetry, termed F1-6C, were calculated using the breast contour and fiducial points assessed on 3D surface images. Associations between all metrics, patient- and physician-reported cosmesis, treatment arm, and  TGFβ1  genotype were performed using the Kruskal-Wallis test and multivariable logistic regression models.
Results


Among 77 (39 CF-WBI and 38 HF-WBI) evaluable patients, both patient- and physician-reported cosmetic outcomes were significantly associated with the F1C vertical symmetry measure (both  P  < .05). Higher dichotomized F1C and volumetric symmetry measures were associated with improved patient- and physician-reported cosmesis on multivariable logistic regression (both  P  ≤ .05). There were no statistically significant differences in vertical symmetry or volume measures between treatment arms. Increased F6C horizontal symmetry was observed in the CF-WBI arm ( P  = .05). Patients with the  TGFβ1  C-509T variant allele had lower F2C vertical symmetry measures ( P  = .02).
Conclusions


Quantitative 3D image-derived measures revealed comparable cosmetic outcomes with HF-WBI compared with CF-WBI. Our findings suggest that 3D surface imaging may be a more sensitive method for measuring subtle cosmetic changes than global patient- or physician-reported assessments.",2020,Higher dichotomized F1C and volumetric symmetry measures were associated with improved patient- and physician-reported cosmesis on multivariable logistic regression (both  P  ≤ .05).,"['Early Stage Breast Cancer', '287 women age ≥40 with ductal carcinoma in situ or early-stage invasive breast cancer']","['3-dimensional (3D) surface photography', 'conventionally fractionated (CF) and hypofractionated (HF) whole breast irradiation (WBI']","['cosmetic outcomes', 'vertical symmetry or volume measures', 'F1C vertical symmetry measure', 'Volume ratios and 6 quantitative measures of breast symmetry, termed F1-6C', 'F2C vertical symmetry measures', 'Increased F6C horizontal symmetry', 'Quantitative 3-Dimensional Photographic Assessment of Breast Cosmesis']","[{'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C4517682', 'cui_str': '287'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0007124', 'cui_str': 'Intraductal carcinoma, noninfiltrating'}, {'cui': 'C0853879', 'cui_str': 'Invasive carcinoma of breast'}]","[{'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0031749', 'cui_str': 'Photography'}, {'cui': 'C0457102', 'cui_str': 'Whole breast'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}]","[{'cui': 'C0010164', 'cui_str': 'Cosmetic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0332516', 'cui_str': 'Symmetrical'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",287.0,0.0244282,Higher dichotomized F1C and volumetric symmetry measures were associated with improved patient- and physician-reported cosmesis on multivariable logistic regression (both  P  ≤ .05).,"[{'ForeName': 'Bhavana V', 'Initials': 'BV', 'LastName': 'Chapman', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Xiudong', 'Initials': 'X', 'LastName': 'Lei', 'Affiliation': 'Health Services Research, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Prithvi', 'Initials': 'P', 'LastName': 'Patil', 'Affiliation': 'Department of Engineering Technology, University of Houston, Houston, Texas.'}, {'ForeName': 'Shikha', 'Initials': 'S', 'LastName': 'Tripathi', 'Affiliation': 'Department of Engineering Technology, University of Houston, Houston, Texas.'}, {'ForeName': 'Krista M', 'Initials': 'KM', 'LastName': 'Nicklaus', 'Affiliation': 'Department of Plastic Surgery, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Aaron J', 'Initials': 'AJ', 'LastName': 'Grossberg', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Simona F', 'Initials': 'SF', 'LastName': 'Shaitelman', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Alastair M', 'Initials': 'AM', 'LastName': 'Thompson', 'Affiliation': 'Breast Surgical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Kelly K', 'Initials': 'KK', 'LastName': 'Hunt', 'Affiliation': 'Breast Surgical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Buchholz', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Fatima', 'Initials': 'F', 'LastName': 'Merchant', 'Affiliation': 'Department of Engineering Technology, University of Houston, Houston, Texas.'}, {'ForeName': 'Mia K', 'Initials': 'MK', 'LastName': 'Markey', 'Affiliation': 'Department of Biomedical Engineering, The University of Texas at Austin, Austin, Texas.'}, {'ForeName': 'Benjamin D', 'Initials': 'BD', 'LastName': 'Smith', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Jay P', 'Initials': 'JP', 'LastName': 'Reddy', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}]",Advances in radiation oncology,['10.1016/j.adro.2020.04.035']
1793,33083676,Erratum: Comparing smoking behavior between female-tomale and male-to-female transgender adults.,[This corrects the article DOI: 10.18332/tpc/114513.].,2020,[This corrects the article DOI: 10.18332/tpc/114513.].,"['female-tomale and male-to-female transgender adults', 'Erratum']",[],[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0558141', 'cui_str': 'Transsexual'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]",[],[],,0.0120902,[This corrects the article DOI: 10.18332/tpc/114513.].,"[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Tobacco prevention & cessation,['10.18332/tpc/125471']
1794,33083790,Efficacy of Neurohormonal Therapies in Preventing Cardiotoxicity in Patients with Cancer Undergoing Chemotherapy.,"Background


Various cardioprotective approaches have been evaluated to prevent chemotherapy-related cardiotoxicity; however, their overall utility remains uncertain.
Objectives


To assess the effects of neurohormonal therapies in preventing cardiotoxicity in patients receiving chemotherapy.
Methods


This meta-analysis included randomized clinical trials of adult patients that underwent chemotherapy and neurohormonal therapies (beta-blockers, mineralocorticoid receptor antagonists, or ACE inhibitors/ARBs) vs. placebo with follow-up ≥4 weeks. The primary outcome was change in left ventricular ejection fraction (LVEF) from baseline to the end of trial. Other outcomes of interest were measures of LV size, strain, and diastolic function. Pooled estimates for each outcome were reported as standardized mean difference (SMD) and weighted mean difference (WMD) between the neurohormonal therapy and placebo groups using random effects models.
Results


We included 17 trials, collectively enrolling 1,984 participants. In pooled analysis, neurohormonal therapy (vs. placebo) was associated with significantly higher LVEF on follow-up [SMD(95% CI): +1.04(0.57 to 1.50)] but with significant heterogeneity in the pooled estimate (I 2  = 96%). Compared with placebo-treated patients, those randomized to neurohormonal therapies experienced a 3.96% (95%CI: 2.9% to 5.0%) less decline in LVEF estimated by WMD, but with significant heterogeneity (I 2  = 98%). There was a trend towards lower adverse clinical events with neurohormonal therapy (vs. placebo) without statistical significance [risk ratio(95%CI): 0.80(0.53-1.20) I 2  = 71%].
Conclusions


Neurohormonal therapies are associated with higher LVEF in follow-up among cancer patients receiving chemotherapy, although absolute changes in LVEF are small and may be within inter-test variability. Furthermore, significant heterogeneity is observed in the treatment effects across studies highlighting the need for larger trials of cardioprotective strategies.",2019,There was a trend towards lower adverse clinical events with neurohormonal therapy (vs. placebo) without statistical significance [risk ratio(95%CI): 0.80(0.53-1.20),"['cancer patients receiving', 'adult patients that underwent', '17 trials, collectively enrolling 1,984 participants', 'patients receiving chemotherapy', 'Patients with Cancer Undergoing Chemotherapy']","['chemotherapy', 'neurohormonal therapies', 'chemotherapy and neurohormonal therapies (beta-blockers, mineralocorticoid receptor antagonists, or ACE inhibitors/ARBs) vs. placebo', 'placebo', 'Neurohormonal Therapies', 'neurohormonal therapy (vs. placebo']","['Cardiotoxicity', 'change in left ventricular ejection fraction (LVEF', 'LV size, strain, and diastolic function']","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0001645', 'cui_str': 'Beta adrenergic receptor antagonist'}, {'cui': 'C1579268', 'cui_str': 'Mineralocorticoid Antagonists'}, {'cui': 'C0003015', 'cui_str': 'Angiotensin-converting enzyme inhibitor'}, {'cui': 'C0521942', 'cui_str': 'Angiotensin II receptor antagonist'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0876994', 'cui_str': 'Cardiotoxicity'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",1984.0,0.517703,There was a trend towards lower adverse clinical events with neurohormonal therapy (vs. placebo) without statistical significance [risk ratio(95%CI): 0.80(0.53-1.20),"[{'ForeName': 'Muthiah', 'Initials': 'M', 'LastName': 'Vaduganathan', 'Affiliation': ""Brigham and Women's Hospital Heart & Vascular Center & Harvard Medical School, Boston, MA.""}, {'ForeName': 'Sameer A', 'Initials': 'SA', 'LastName': 'Hirji', 'Affiliation': ""Division of Cardiac Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Arman', 'Initials': 'A', 'LastName': 'Qamar', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Navkaranbir', 'Initials': 'N', 'LastName': 'Bajaj', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Ankur', 'Initials': 'A', 'LastName': 'Gupta', 'Affiliation': 'Division of Cardiology, University of Texas Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Vlad', 'Initials': 'V', 'LastName': 'Zaha', 'Affiliation': 'Division of Cardiology, University of Texas Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Alvin', 'Initials': 'A', 'LastName': 'Chandra', 'Affiliation': ""Brigham and Women's Hospital Heart & Vascular Center & Harvard Medical School, Boston, MA.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Haykowsky', 'Affiliation': 'College of Nursing and Health Innovation, University of Texas at Arlington, Arlington, TX.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Ky', 'Affiliation': 'Cardiovascular Institute, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Javid', 'Initials': 'J', 'LastName': 'Moslehi', 'Affiliation': 'Cardio-Oncology Program, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Anju', 'Initials': 'A', 'LastName': 'Nohria', 'Affiliation': ""Brigham and Women's Hospital Heart & Vascular Center & Harvard Medical School, Boston, MA.""}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Butler', 'Affiliation': 'Department of Medicine, University of Mississippi, Jackson, MS.'}, {'ForeName': 'Ambarish', 'Initials': 'A', 'LastName': 'Pandey', 'Affiliation': 'Division of Cardiology, University of Texas Southwestern Medical Center, Dallas, TX.'}]",JACC. CardioOncology,['10.1016/j.jaccao.2019.08.006']
1795,33083852,Effect of Lactobacillus brevis CD2 containing lozenges and plaque pH and cariogenic bacteria in diabetic children: a randomised clinical trial.,"OBJECTIVE


The short-term effect (60 days) of Lactobacillus brevis CD2 lozenges vs placebo on variables related to caries and gingivitis in type 1 diabetic children was evaluated.
MATERIAL AND METHODS


Eight diabetics (4-14 years old) were assigned to two groups (n = 34 subjects each), probiotic lozenges and placebo. Stimulated saliva for microbiological analysis and plaque pH were assessed at baseline (t 0 ), 30 days (t 1 ), 60 days (t 2 ) and in the follow-up period (90 days from baseline, t 3 ). Gingival status was assessed at t 0 , t 2  and t 3 . Two-way ANOVA assessed differences between groups.
RESULTS


In the probiotic group, Streptococcus mutans bacterial density mean scores dropped from 3.11 ± 1.13 at baseline to 1.82 ± 0.72 (t 2 ) and to 2.06 ± 0.56 (t 3 ), while in the placebo group, the scores were 3.09 ± 0.8 (t 0 ), 2.82 ± 0.47 (t 2 ) and 3.11 ± 0.43 (t 3 ) (p < 0.01). Lowest and maximum pH fall increased in the probiotic group, from 5.37 ± 0.41 at baseline to 5.49 ± 0.24 at t 3  (p < 0.01) and from 1.20 ± 0.46 to 0.98 ± 0.29 (p = 0.02). Bleeding score decreased significantly in both groups, showing a statistically significant lower bleeding score at t 2  in the probiotic group (25.6%, 95% CI 21.5-32.7 vs 29.5%, 95% CI 25.2-34.9, p = 0.02).
CONCLUSIONS


Lactobacillus brevis CD2 has shown to improve caries-related risk factors and gingival health in diabetic children.
CLINICAL RELEVANCE


Lactobacillus brevis CD2 might contribute to improved oral health in type 1 diabetic children.",2020,"In the probiotic group, Streptococcus mutans bacterial density mean scores dropped from 3.11 ± 1.13 at baseline to 1.82 ± 0.72 (t 2 ) and to 2.06 ± 0.56 (t 3 ), while in the placebo group, the scores were 3.09 ± 0.8 (t 0 ), 2.82 ± 0.47 (t 2 ) and 3.11 ± 0.43 (t 3 ) (p < 0.01).","['type 1 diabetic children', 'Eight diabetics (4-14 years old', 'diabetic children']","['Lactobacillus brevis CD2 lozenges vs placebo', 'Lactobacillus brevis CD2 containing lozenges and plaque pH and cariogenic bacteria', 'Lactobacillus brevis CD2', 'probiotic lozenges and placebo', 'Lactobacillus']","['Bleeding score', 'Streptococcus mutans bacterial density mean scores', 'Gingival status', 'Stimulated saliva for microbiological analysis and plaque pH', 'maximum pH fall', 'bleeding score', 'oral health']","[{'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0425067', 'cui_str': 'Diabetic child'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0317604', 'cui_str': 'Lactobacillus brevis'}, {'cui': 'C0108773', 'cui_str': 'Lymphocyte antigen CD2'}, {'cui': 'C0991564', 'cui_str': 'Lozenge'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0022938', 'cui_str': 'Lactobacillus'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0038402', 'cui_str': 'Streptococcus'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0025953', 'cui_str': 'microbiology'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",,0.186119,"In the probiotic group, Streptococcus mutans bacterial density mean scores dropped from 3.11 ± 1.13 at baseline to 1.82 ± 0.72 (t 2 ) and to 2.06 ± 0.56 (t 3 ), while in the placebo group, the scores were 3.09 ± 0.8 (t 0 ), 2.82 ± 0.47 (t 2 ) and 3.11 ± 0.43 (t 3 ) (p < 0.01).","[{'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Lai', 'Affiliation': 'Department of Biomedical Sciences-Medical School, University of Sassari, Sassari, Italy.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lingström', 'Affiliation': 'Department of Cariology, Institute of Odontology, The Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Maria Grazia', 'Initials': 'MG', 'LastName': 'Cagetti', 'Affiliation': 'Department of Biomedical, Surgical and Dental Sciences, University of Milan, Milan, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Cocco', 'Affiliation': 'Department of Surgery, Medical and Experimental Sciences, University of Sassari, Sassari, Italy. fcocco@uniss.it.'}, {'ForeName': 'Gianfranco', 'Initials': 'G', 'LastName': 'Meloni', 'Affiliation': 'Department of Surgery, Medical and Experimental Sciences, University of Sassari, Sassari, Italy.'}, {'ForeName': 'Maria Antonietta', 'Initials': 'MA', 'LastName': 'Arrica', 'Affiliation': 'Department of Surgery, Medical and Experimental Sciences, University of Sassari, Sassari, Italy.'}, {'ForeName': 'Guglielmo', 'Initials': 'G', 'LastName': 'Campus', 'Affiliation': 'Department of Surgery, Medical and Experimental Sciences, University of Sassari, Sassari, Italy.'}]",Clinical oral investigations,['10.1007/s00784-020-03342-0']
1796,33083901,Comment on Cheng et al.: Intramedullary nailing via suprapatellar approach versus locked plating of proximal extra-articular tibial fractures: a randomized control trial.,,2020,,['proximal extra-articular tibial fractures'],[' Intramedullary nailing via suprapatellar approach versus locked plating'],[],"[{'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0205135', 'cui_str': 'Extra-articular'}, {'cui': 'C0040185', 'cui_str': 'Fracture of tibia'}]","[{'cui': 'C0021885', 'cui_str': 'Bone nailing'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0407295', 'cui_str': 'Fixation of fracture using plate'}]",[],,0.0274446,,"[{'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Yin', 'Affiliation': 'Department of Orthopaedics, The Third Affiliated Hospital of An Hui Medical University, Hefei, China. helloyh2008@126.com.'}]",International orthopaedics,['10.1007/s00264-020-04861-x']
1797,32960632,"Evaluation of the acceptability of low glycaemic index preparations, formulated by replicating traditional Chilean culinary preparations with a high glycaemic index.","Introduction


The aim of this study was to determine the acceptability of low glycaemic index (GI) preparations, equivalent to the traditional high GI ones in Chile, elaborated with minimal changes in the ingredients and culinary techniques that significantly diminish the GI and maintain acceptability level. Twelve high-GI traditional lunches and their low GI counterparts were prepared. For 12 days, 20 apparently healthy women randomly tasted 2 paired preparations per day (low and high GI). The attributes of appearance, taste, smell, and texture of salads, main course, and desserts, as well as those of the full lunch, were evaluated using a hedonic scale of 7 and 9 points. Lunches with a high GI (90 ± 20.5 %) were modified by changing types of food ingredients, and/or by using culinary techniques to provide a low-GI counterpart with 47 ± 5.9 % GI (p < 0.001). All the preparations were classified as optimal, exceeding the established cut-off point. The ""Legume with CHO"" lunch had a higher acceptability level in its low GI version (p = 0.006), while the ""Chicken with corn"" lunch had it in its high GI version (p = 0.004). There was a preference for low-GI salad appearance (p = 0.003) and dessert flavour (p = 0.024), while high-GI main dishes were better praised for flavour (p = 0.034) and texture (p = 0.012). It is therefore possible to prepare low-GI menus equivalent to their traditional counterparts that are received as generally acceptable, with components and sensory attributes equal to, or even better than typical Chilean cuisine dishes.",2020,"The ""Legume with CHO"" lunch had a higher acceptability level in its low GI version (p = 0.006), while the ""Chicken with corn"" lunch had it in its high GI version (p = 0.004).",['20 apparently healthy women'],"['CHO"" lunch']","['appearance, taste, smell, and texture of salads, main course, and desserts', 'acceptability level', 'acceptability of low glycaemic index (GI) preparations', 'low-GI salad appearance']","[{'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0054889', 'cui_str': 'CAV protocol'}, {'cui': 'C2697949', 'cui_str': 'Lunch'}]","[{'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0039336', 'cui_str': 'Finding of sense of taste'}, {'cui': 'C0037361', 'cui_str': 'Sense of smell, function'}, {'cui': 'C0449582', 'cui_str': 'With texture'}, {'cui': 'C0453740', 'cui_str': 'Salad'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0453505', 'cui_str': 'Dessert'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",20.0,0.0235228,"The ""Legume with CHO"" lunch had a higher acceptability level in its low GI version (p = 0.006), while the ""Chicken with corn"" lunch had it in its high GI version (p = 0.004).","[{'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Vega', 'Affiliation': 'Universidad de Valparaíso.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Priken Figueroa', 'Affiliation': 'Universidad de Valparaíso.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Venegas', 'Affiliation': 'Universidad de Valparaíso.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Vera Fontecha', 'Affiliation': 'Universidad de Valparaíso.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Pincheira Ruiz', 'Affiliation': 'Universidad de Valparaíso.'}, {'ForeName': 'Marcela', 'Initials': 'M', 'LastName': 'Alviña Walker', 'Affiliation': 'Universidad de Valparaíso.'}]",Nutricion hospitalaria,['10.20960/nh.02963']
1798,32985439,High uptake of an innovative mobile phone application among community health workers in rural India: An implementation study.,"Background


We assessed the uptake, feasibility and effectiveness of an mHealth intervention in improving the performance of village-based frontline workers, called accredited social health activists (ASHAs), to increase the coverage of maternal, newborn and child health services in rural India.
Methods


A new mobile phone application-Innovative Mobile-phone Technology for Community Health Operations (ImTeCHO)-was implemented in all the 45 villages of two primary health centres in Jhagadia, Gujarat (population ~45 000), between August 2013 and February 2014 after training 45 ASHAs. After 9 months of implementation, 99 mothers of young infants between the ages of 1 and 4 months and 187 mothers of infants between the ages of 6 and 9 months were interviewed during the household survey to assess the coverage of maternal, newborn and child health services in the project and similar control villages. Fifteen ASHAs were purposively selected and interviewed.
Results


The coverage of home-based newborn care (56% v. 10%), exclusive breastfeeding (44% v. 23%), care-seeking for maternal (77% v. 57%) and neonatal complications (78% v. 27%) and pneumonia (41% v. 24%) improved in the interventional area compared to the control area. The ASHAs logged into the mobile phone application on 88% of working days. Of a total of 10 774 forms required to be completed, the ASHAs completed 7710 forms. During the interviews, all ASHAs demonstrated sufficient competency to use ImTeCHO and expressed a high level of acceptability and utility of all components of the intervention.
Conclusion


A high degree of acceptability, feasibility and effectiveness for the mHealth intervention among ASHAs was supported by its widespread use.",2019,"During the interviews, all ASHAs demonstrated sufficient competency to use ImTeCHO and expressed a high level of acceptability and utility of all components of the intervention.
","['rural India', '45 villages of two primary health centres in Jhagadia, Gujarat (population ~45 000), between August 2013 and February 2014 after training 45 ASHAs', '99 mothers of young infants between the ages of 1 and 4 months and 187 mothers of infants between the ages of 6 and 9 months were interviewed during the household survey to assess the coverage of maternal, newborn and child health services in the project and similar control villages', 'Of a total of 10 774 forms required to be completed, the ASHAs completed 7710 forms', 'community health workers in rural India', 'Fifteen ASHAs were purposively selected and interviewed']",['mHealth intervention'],"['pneumonia', 'exclusive breastfeeding', 'acceptability, feasibility and effectiveness', 'neonatal complications', 'coverage of home-based newborn care', 'care-seeking for maternal']","[{'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4517618', 'cui_str': '187'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0008079', 'cui_str': 'Health Services, Child'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0242205', 'cui_str': 'Breastfeeding, Exclusive'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0204792', 'cui_str': 'Routine care of newborn'}, {'cui': 'C0026591', 'cui_str': 'Mother'}]",15.0,0.027687,"During the interviews, all ASHAs demonstrated sufficient competency to use ImTeCHO and expressed a high level of acceptability and utility of all components of the intervention.
","[{'ForeName': 'Pankaj', 'Initials': 'P', 'LastName': 'Shah', 'Affiliation': 'Community Health Department, SEWA-Rural, Jhagadia, Bharuch 393110, Gujarat, India.'}, {'ForeName': 'Neha', 'Initials': 'N', 'LastName': 'Madhiwala', 'Affiliation': 'Independent Consultant.'}, {'ForeName': 'Shobha', 'Initials': 'S', 'LastName': 'Shah', 'Affiliation': 'Community Health Department, SEWA-Rural, Jhagadia, Bharuch 393110, Gujarat, India.'}, {'ForeName': 'Gayatri', 'Initials': 'G', 'LastName': 'Desai', 'Affiliation': 'Community Health Department, SEWA-Rural, Jhagadia, Bharuch 393110, Gujarat, India.'}, {'ForeName': 'Kapilkumar', 'Initials': 'K', 'LastName': 'Dave', 'Affiliation': 'Community Health Department, SEWA-Rural, Jhagadia, Bharuch 393110, Gujarat, India.'}, {'ForeName': 'Nishith', 'Initials': 'N', 'LastName': 'Dholakia', 'Affiliation': 'Family Welfare, Commissionerate of Health, Government of Gujarat, Block 5, Dr Jivraj Mehta Bhavan, Gandhinagar, Gujarat 382010, India.'}, {'ForeName': 'Shivani', 'Initials': 'S', 'LastName': 'Patel', 'Affiliation': 'Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'Shrey', 'Initials': 'S', 'LastName': 'Desai', 'Affiliation': 'Community Health Department, SEWA-Rural, Jhagadia, Bharuch 393110, Gujarat, India.'}, {'ForeName': 'Dhiren', 'Initials': 'D', 'LastName': 'Modi', 'Affiliation': 'Community Health Department, SEWA-Rural, Jhagadia, Bharuch 393110, Gujarat, India.'}]",The National medical journal of India,['10.4103/0970-258X.295956']
1799,33066763,"Prevalence and determinants of undernutrition among under-five children residing in urban slums and rural area, Maharashtra, India: a community-based cross-sectional study.","BACKGROUND


Undernutrition among under five children in India is a major public health problem. Despite India's growth in the economy, the child mortality rate due to undernutrition is still high in both urban and rural areas. Studies that focus on urban slums are scarce. Hence the present study was carried out to assess the prevalence and determinants of undernutrition in children under five in Maharashtra, India.
METHODS


A community-based cross-sectional study was conducted in 16 randomly selected clusters in two districts of Maharashtra state, India. Data were collected through house to house survey by interviewing mothers of under five children. Total 2929 mothers and their 3671 under five children were covered. Multivariate logistic regression analysis was carried out to identify the determinants of child nutritional status seperately in urban and rural areas.
RESULTS


The mean age of the children was 2.38 years (±SD 1.36) and mean age of mothers was 24.25 years (± SD 6.37). Overall prevalence of stunting among children under five was 45.9%, wasting was 17.1 and 35.4% children were underweight. Prevalence of wasting, stunting and underweight were more seen in an urban slum than a rural area. In the rural areas exclusive breast feeding (p < 0.001) and acute diarrhea (p = 0.001) were associated with wasting, children with birth order 2 or less than 2 were associated with stunting and exclusive breast feeding (p < 0.05) and low maternal education were associated with underweight. Whereas in the urban slums exclusive breast feeding (p < 0.05) was associated with wasting, sex of the child (p < 0.05) and type of family (p < 0.05) were associated with stunting,and low income of the family (p < 0.05) was associated with underweight.
CONCLUSIONS


Factors like sex of the child, birth order,exclusive breast feeding,economic status of the family, type of family,acute diarrhea and maternal education have influence on nutritional status of the child. Improvement of maternal education will improve the nutritional status of the child. Strategies are needed to improve the economic status of the community.
TRIAL REGISTRATION


Trial registration number: CTRI/2017/12/010881 ; Registration date:14/12/2017. Retrospectively registered.",2020,"Prevalence of wasting, stunting and underweight were more seen in an urban slum than a rural area.","['children under five in Maharashtra, India', 'A community-based cross-sectional study was conducted in 16 randomly selected clusters in two districts of Maharashtra state, India', 'The mean age of the children was 2.38\u2009years (±SD 1.36) and mean age of mothers was 24.25\u2009years (± SD 6.37', 'Total 2929 mothers and their 3671 under five children were covered']",[],"['Prevalence of wasting, stunting and underweight', 'low maternal education', 'acute diarrhea', 'stunting and exclusive breast feeding', 'Overall prevalence of stunting']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4708912', 'cui_str': '1.36'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0439844', 'cui_str': 'Covered'}]",[],"[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0006625', 'cui_str': 'Cachexia'}, {'cui': 'C0018273', 'cui_str': 'Growth disorder'}, {'cui': 'C0041667', 'cui_str': 'Underweight'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0740441', 'cui_str': 'Acute diarrhea'}, {'cui': 'C0242205', 'cui_str': 'Breastfeeding, Exclusive'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",16.0,0.027812,"Prevalence of wasting, stunting and underweight were more seen in an urban slum than a rural area.","[{'ForeName': 'Sujata', 'Initials': 'S', 'LastName': 'Murarkar', 'Affiliation': 'Department of Community Medicine, Bharati Vidyapeeth Deemed to be University Medical College, Off Pune Satara Road, Pune, 411043, India.'}, {'ForeName': 'Jayashree', 'Initials': 'J', 'LastName': 'Gothankar', 'Affiliation': 'Department of Community Medicine, Bharati Vidyapeeth Deemed to be University Medical College, Off Pune Satara Road, Pune, 411043, India. Jayashreesg@rediffmail.com.'}, {'ForeName': 'Prakash', 'Initials': 'P', 'LastName': 'Doke', 'Affiliation': 'Department of Community Medicine, Bharati Vidyapeeth Deemed to be University Medical College, Off Pune Satara Road, Pune, 411043, India.'}, {'ForeName': 'Prasad', 'Initials': 'P', 'LastName': 'Pore', 'Affiliation': 'Department of Community Medicine, Bharati Vidyapeeth Deemed to be University Medical College, Off Pune Satara Road, Pune, 411043, India.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Lalwani', 'Affiliation': 'Department of Pediatrics, Bharati Vidyapeeth Deemed to be University Medical College, Pune, India.'}, {'ForeName': 'Girish', 'Initials': 'G', 'LastName': 'Dhumale', 'Affiliation': 'Department of Community Medicine, Bharati Vidyapeeth Deemed to be University Medical College, Sangli, India.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Quraishi', 'Affiliation': 'Department of Community Medicine, Bharati Vidyapeeth Deemed to be University Medical College, Sangli, India.'}, {'ForeName': 'Reshma', 'Initials': 'R', 'LastName': 'Patil', 'Affiliation': 'Department of Community Medicine, Symbiosis Medical College for women, Pune, Maharashtra, India.'}, {'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Waghachavare', 'Affiliation': 'Department of Community Medicine, Bharati Vidyapeeth Deemed to be University Medical College, Sangli, India.'}, {'ForeName': 'Randhir', 'Initials': 'R', 'LastName': 'Dhobale', 'Affiliation': 'Department of Community Medicine, Bharati Vidyapeeth Deemed to be University Medical College, Sangli, India.'}, {'ForeName': 'Kirti', 'Initials': 'K', 'LastName': 'Rasote', 'Affiliation': 'Department of Community Medicine, Bharati Vidyapeeth Deemed to be University Medical College, Sangli, India.'}, {'ForeName': 'Sonali', 'Initials': 'S', 'LastName': 'Palkar', 'Affiliation': 'Department of Community Medicine, Bharati Vidyapeeth Deemed to be University Medical College, Off Pune Satara Road, Pune, 411043, India.'}, {'ForeName': 'Nandini', 'Initials': 'N', 'LastName': 'Malshe', 'Affiliation': 'Department of Pediatrics, Bharati Vidyapeeth Deemed to be University Medical College, Pune, India.'}]",BMC public health,['10.1186/s12889-020-09642-0']
1800,33082989,The role of psychological attribution in responses to weight stigma.,"Objective


Weight discrimination is associated with numerous negative health consequences. Little is known about early-stage psychological mechanisms that explain variability in responses to weight discrimination among people with obesity. This study tested the hypothesis that attributing negative social evaluation to one's weight would be associated with stigma-related stress responses (eg, reduced cognitive functioning and self-esteem, increased negative affect and cortisol), especially among people who had experienced frequent weight discrimination in the past.
Methods


Adults (N = 109) with obesity were randomly assigned to receive a mildly positive (control) versus negative social evaluation. The extent to which participants attributed the negative evaluation to their physical appearance was assessed, along with negative affect, social and appearance self-esteem, cognitive functioning and salivary cortisol.
Results


Participants who had experienced frequent weight discrimination in the past were more likely to attribute the negative evaluation to their appearance. Participants who attributed the negative evaluation to their appearance in turn experienced elevated negative affect, lower appearance self-esteem and worse cognitive functioning.
Conclusions


This study is among the first to identify attribution as an early-stage process underlying responses to weight stigma. Attribution may be a key psychological factor conferring risk for or protection from the negative effects of weight stigma.",2020,"Participants who attributed the negative evaluation to their appearance in turn experienced elevated negative affect, lower appearance self-esteem and worse cognitive functioning.
","['people who had experienced frequent weight discrimination in the past', 'people with obesity', 'Methods\n\n\nAdults (N = 109) with obesity']",['mildly positive (control) versus negative social evaluation'],"['frequent weight discrimination', 'appearance self-esteem and worse cognitive functioning', 'social and appearance self-esteem, cognitive functioning and salivary cortisol']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0012632', 'cui_str': 'Cognitive discrimination'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C2945599', 'cui_str': 'Mild'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}]","[{'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0012632', 'cui_str': 'Cognitive discrimination'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}]",109.0,0.0206514,"Participants who attributed the negative evaluation to their appearance in turn experienced elevated negative affect, lower appearance self-esteem and worse cognitive functioning.
","[{'ForeName': 'Mary A', 'Initials': 'MA', 'LastName': 'Gerend', 'Affiliation': 'Department of Behavioral Sciences and Social Medicine, College of Medicine Florida State University Tallahassee Florida USA.'}, {'ForeName': 'Angelina R', 'Initials': 'AR', 'LastName': 'Sutin', 'Affiliation': 'Department of Behavioral Sciences and Social Medicine, College of Medicine Florida State University Tallahassee Florida USA.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Terracciano', 'Affiliation': 'Department of Geriatrics, College of Medicine Florida State University Tallahassee Florida USA.'}, {'ForeName': 'Jon K', 'Initials': 'JK', 'LastName': 'Maner', 'Affiliation': 'Department of Psychology, College of Arts and Sciences Florida State University Tallahassee Florida USA.'}]",Obesity science & practice,['10.1002/osp4.437']
1801,33083016,Gut microbiota patterns associated with somatostatin in patients undergoing pancreaticoduodenectomy: a prospective study.,"Postoperative pancreatic fistula (POPF) is a common and dreaded complication after pancreaticoduodenectomy (PD). The gut microbiota has been considered as an crucial mediator of postoperative complications, however, the precise roles of gut microbiota in POPF are unclear. A prospective study was developed to explore the effects of somatostatin on gut microbiota and we aim to identify the microbial alterations in the process of POPF. A total of 45 patients were randomly divided into PD group or additional somatostatin therapy group. The fecal sample of each patient was collected preoperatively and postoperatively and the gut microbiota was analyzed by 16S rRNA sequencing. Our study found that somatostatin therapy was independent risk factor for the occurrence of POPF, and it reduced the microbial diversity and richness in patients. At genus level, somatostatin therapy led to a decreased abundance in Bifidobacterium, Subdoligranulum and Dubosiella, whereas the abundance of Akkermansia, Enterococcus and Enterobacter were increased. The abundance levels of certain bacteria in the gut microbiota have significantly shifted in patients with POPF. The LEfSe analysis revealed that Ruminococcaceae could be used as microbial markers for distinguishing patients with high risk of POPF. Furthermore, Verrucomicrobia and Akkermansia could be used as preoperative biomarkers for identifying patients without POPF. Our prospective study highlights the specific communities related with somatostatin therapy and discovers POPF-associated microbial marker, which suggests that gut microbiota may become a diagnostic biomarker and potential therapeutic target for POPF.",2020,"At genus level, somatostatin therapy led to a decreased abundance in Bifidobacterium, Subdoligranulum and Dubosiella, whereas the abundance of Akkermansia, Enterococcus and Enterobacter were increased.","['patients undergoing pancreaticoduodenectomy', 'patients with POPF', '45 patients']","['PD group or additional somatostatin therapy group', 'somatostatin', 'somatostatin therapy']","['Postoperative pancreatic fistula (POPF', 'abundance in Bifidobacterium, Subdoligranulum and Dubosiella, whereas the abundance of Akkermansia, Enterococcus and Enterobacter']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085162', 'cui_str': 'Pancreaticoduodenectomy'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0030290', 'cui_str': 'Pancreatic fistula'}]","[{'cui': 'C0085162', 'cui_str': 'Pancreaticoduodenectomy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0037659', 'cui_str': 'Somatostatin'}, {'cui': 'C1527374', 'cui_str': 'Group Therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0030290', 'cui_str': 'Pancreatic fistula'}, {'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}, {'cui': 'C1503440', 'cui_str': 'Subdoligranulum'}, {'cui': 'C1490589', 'cui_str': 'Akkermansia'}, {'cui': 'C0085494', 'cui_str': 'Genus Enterococcus'}, {'cui': 'C0014344', 'cui_str': 'Enterobacter'}]",45.0,0.0160419,"At genus level, somatostatin therapy led to a decreased abundance in Bifidobacterium, Subdoligranulum and Dubosiella, whereas the abundance of Akkermansia, Enterococcus and Enterobacter were increased.","[{'ForeName': 'Guan-Qun', 'Initials': 'GQ', 'LastName': 'Li', 'Affiliation': 'Department of Pancreatic and Biliary Surgery, The First Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': 'Department of Pancreatic and Biliary Surgery, The First Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang China.'}, {'ForeName': 'Wei-Guang', 'Initials': 'WG', 'LastName': 'Yang', 'Affiliation': 'Department of Pancreatic and Biliary Surgery, The First Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang China.'}, {'ForeName': 'Hao-Liang', 'Initials': 'HL', 'LastName': 'Zhong', 'Affiliation': 'Department of Pancreatic and Biliary Surgery, The First Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Xiao', 'Affiliation': 'Department of Pancreatic and Biliary Surgery, The First Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang China.'}, {'ForeName': 'Li-Wei', 'Initials': 'LW', 'LastName': 'Liu', 'Affiliation': 'Department of Pancreatic and Biliary Surgery, The First Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang China.'}, {'ForeName': 'Yong-Wei', 'Initials': 'YW', 'LastName': 'Wang', 'Affiliation': 'Department of Pancreatic and Biliary Surgery, The First Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Pancreatic and Biliary Surgery, The First Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Kong', 'Affiliation': 'Department of Pancreatic and Biliary Surgery, The First Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'Department of Pancreatic and Biliary Surgery, The First Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang China.'}, {'ForeName': 'Hong-Tao', 'Initials': 'HT', 'LastName': 'Tan', 'Affiliation': 'Department of Pancreatic and Biliary Surgery, The First Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang China.'}, {'ForeName': 'Xue-Wei', 'Initials': 'XW', 'LastName': 'Bai', 'Affiliation': 'Department of Pancreatic and Biliary Surgery, The First Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang China.'}, {'ForeName': 'Yi-Long', 'Initials': 'YL', 'LastName': 'Li', 'Affiliation': 'Department of Pancreatic and Biliary Surgery, The First Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang China.'}, {'ForeName': 'Le', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Pancreatic and Biliary Surgery, The First Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang China.'}, {'ForeName': 'Bei', 'Initials': 'B', 'LastName': 'Sun', 'Affiliation': 'Department of Pancreatic and Biliary Surgery, The First Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang China.'}]",Cell death discovery,['10.1038/s41420-020-00329-4']
1802,33083047,Intracorneal Stromal Ring Can Affect the Biomechanics of Ectatic Cornea.,"Purpose


The biomechanical properties of ecstatic cornea undergo changes. This study evaluates the biomechanical changes of ecstatic cornea after implantation of two types of intracorneal stromal ring (ICR).
Methods


For doing this prospective cross-sectional study, 32 patients with keratoconus (KCN) were randomly divided into two 16-member groups (group I: MyoRing, group II: KeraRing). The main inclusion criteria were transparent cornea with no scar in the central part, corneal thickness >450  µ  in the incision region, keratometry within 48-52 diopters, and progressive course of corneal thinning. Biomechanics of the cornea was evaluated by ""ORA"" and ""Corvis"" devices. All of the data were recorded and analyzed before implantation of the rings and 6 months thereafter.
Results


The mean ages of patients of groups I and II were 26 ± 6.55 and 33.86 ± 8.5, respectively. The postoperative change of sphere refraction was significant in both groups. However, reduction in the astigmatism was significant only in group I. In addition, the change of flat meridian keratometry (Kf) was significant before and after ring implantation in group I, unlike group II. The changes in CH and CRF parameters (ORA) were not significant in either group before and after the operation. Besides, only HRC parameter (Corvis) decreased significantly in both groups before and after the operation.
Conclusion


Both MyoRing and KeraRings have positive effects on the biomechanics of cornea at least during the first year after implantation. Comparison of these two types of ICR did not show significant differences in Corvis and ORA parameters.",2020,Both MyoRing and KeraRings have positive effects on the biomechanics of cornea at least during the first year after implantation.,['32 patients with keratoconus (KCN'],['intracorneal stromal ring (ICR'],"['change of flat meridian keratometry (Kf', 'Biomechanics of Ectatic Cornea', 'changes in CH and CRF parameters (ORA', 'HRC parameter (Corvis', 'Corvis and ORA parameters', 'corneal thickness', 'postoperative change of sphere refraction', 'progressive course of corneal thinning']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022578', 'cui_str': 'Keratoconus'}]","[{'cui': 'C0521164', 'cui_str': 'Annular shape'}]","[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205324', 'cui_str': 'Flat'}, {'cui': 'C0085282', 'cui_str': 'Jingluo'}, {'cui': 'C0430885', 'cui_str': 'Keratometry'}, {'cui': 'C0700124', 'cui_str': 'Ectatic'}, {'cui': 'C0010031', 'cui_str': 'Corneal structure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0010132', 'cui_str': 'Corticotropin-Releasing Hormone'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0429493', 'cui_str': 'Corneal thickness'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332501', 'cui_str': 'Spherical shape'}, {'cui': 'C0429585', 'cui_str': 'Refraction measurement - finding'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C1096274', 'cui_str': 'Corneal thinning'}]",32.0,0.016743,Both MyoRing and KeraRings have positive effects on the biomechanics of cornea at least during the first year after implantation.,"[{'ForeName': 'Shahram', 'Initials': 'S', 'LastName': 'Bamdad', 'Affiliation': 'Poostchi Ophthalmology Research Center, Department of Ophthalmology, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Sedaghat', 'Affiliation': 'Department of Ophthalmology, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Yasemi', 'Affiliation': 'Poostchi Ophthalmology Research Center, Department of Ophthalmology, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mehrnoosh', 'Initials': 'M', 'LastName': 'Maalhagh', 'Affiliation': 'Poostchi Ophthalmology Research Center, Department of Ophthalmology, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",Journal of ophthalmology,['10.1155/2020/4274037']
1803,33083052,Reporting of Safety Events during Anti-VEGF Treatment: Pharmacovigilance in a Noninterventional Trial.,"Aim


The prospective, noninterventional OCEAN study assessed the safety of intravitreal ranibizumab injections for treatment of neovascular age-related macular degeneration, diabetic macular edema, and retinal vein occlusion under real-world conditions in Germany.
Methods


Adults receiving ≥1 ranibizumab (0.5 mg) injections were recruited by 369 ophthalmologists and followed for 24 months. Information on adverse events (AEs) was reported by the treating physician or detected by the data management team. Collected information included observed AE, AE start and end date, intensity, causal relationship, outcome, severity, suspected drug, and actions taken.
Results


2,687 AEs were reported for 1,176 of the 5,781 patients who had received a total of 32,621 injections: 27.4% nonserious AEs, 30.3% serious AEs, 27.3% nonserious adverse drug reactions (ADRs), and 15.0% serious ADRs. Most patients reported no AEs (79.7%) or only 1 AE (10.3%). AEs were most commonly reported in the Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) Eye disorders (9.4% of patients) and General disorders and administration site conditions (5.8%). The most frequent AEs by MedDRA preferred term (PT) were visual acuity reduced (3.5% of patients), intraocular pressure increased (2.5%), and drug ineffective (2.1%). AEs occurred most frequently after 3 or 4 injections (1,129 of 2,687 AEs). The proportion of AEs in the SOC Eye disorders decreased slightly with increasing number of injections, from 39.8% of events after 1 or 2 injections to 29.1% after 5 or more injections. Rates of the most frequently reported PTs did not show any consistent increase with increasing number of injections. A decrease in overall AE rates was observed over the study course.
Conclusions


The results did not raise any new safety concerns for ranibizumab. The findings allow conclusions to be drawn on how pharmacovigilance data can be collected even more effectively in real-world studies to facilitate discussion on benefit-risk ratio.",2020,The results did not raise any new safety concerns for ranibizumab.,"['neovascular age-related macular degeneration, diabetic macular edema, and retinal vein occlusion under real-world conditions in Germany', '2,687 AEs were reported for 1,176 of the 5,781 patients who had received a total of 32,621 injections: 27.4% nonserious AEs, 30.3% serious AEs, 27.3% nonserious adverse drug reactions (ADRs), and 15.0% serious ADRs', '0.5\u2009mg) injections were recruited by 369 ophthalmologists and followed for 24 months']","['intravitreal ranibizumab injections', 'ranibizumab', 'Anti-VEGF Treatment']","['AE, AE start and end date, intensity, causal relationship, outcome, severity, suspected drug, and actions taken', 'visual acuity', 'number of injections', 'intraocular pressure', 'Regulatory Activities (MedDRA) System Organ Class (SOC) Eye disorders', 'adverse events (AEs', 'overall AE rates']","[{'cui': 'C0271084', 'cui_str': 'Exudative age-related macular degeneration'}, {'cui': 'C0730285', 'cui_str': 'Macular edema due to diabetes mellitus'}, {'cui': 'C0035328', 'cui_str': 'Retinal vein occlusion'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C5192328', 'cui_str': '27.4'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C1704292', 'cui_str': 'Ophthalmologist'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C4050112', 'cui_str': 'ranibizumab Injection'}, {'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0806020', 'cui_str': 'End date'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0012113', 'cui_str': 'Dictionary, Medical'}, {'cui': 'C0460002', 'cui_str': 'Body system structure'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0015397', 'cui_str': 'Disorder of eye'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",2687.0,0.104377,The results did not raise any new safety concerns for ranibizumab.,"[{'ForeName': 'Focke', 'Initials': 'F', 'LastName': 'Ziemssen', 'Affiliation': 'Centre for Ophthalmology, Eberhard-Karls-University Tuebingen, 72076 Tuebingen, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hammer', 'Affiliation': 'Augenzentrum Halle, Dessauer Str. 194, 06118 Halle, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Grueb', 'Affiliation': 'Centre for Ophthalmology, Eberhard-Karls-University Tuebingen, 72076 Tuebingen, Germany.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Mueller', 'Affiliation': 'Novartis Pharma GmbH, 90429 Nuremberg, Germany.'}, {'ForeName': 'Hüsnü', 'Initials': 'H', 'LastName': 'Berk', 'Affiliation': 'St. Elisabeth Klinik Hohenlind, Cologne, Germany.'}, {'ForeName': 'Maria-Andreea', 'Initials': 'MA', 'LastName': 'Gamulescu', 'Affiliation': 'Universitätsaugenklinik Regensburg, Franz-Josef-Strauss Allee 11, 93051 Regensburg, Germany.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Voegeler', 'Affiliation': 'Novartis Pharma GmbH, 90429 Nuremberg, Germany.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Wachtlin', 'Affiliation': 'Departement of Ophthalmology, Sankt-Gertrauden Krankenhaus, Paretzer Str. 12, 10713 Berlin, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Ocean Study Group', 'Affiliation': 'Centre for Ophthalmology, Eberhard-Karls-University Tuebingen, 72076 Tuebingen, Germany.'}]",Journal of ophthalmology,['10.1155/2020/8652370']
1804,33083194,Impact of Early Urine Specimen Collection on Emergency Department Time to Disposition: A Randomized Controlled Trial.,"Background Diagnostic testing in the ED increases the length of stay (LOS). Urinalysis testing is highlighted specifically as a source of delays. We aim to determine whether a triage-initiated urine specimen collection process decreases ED time to disposition (TTD) in ambulatory patients with abdominal pain. Methods This prospective, randomized controlled study was implemented at a Suburban Level One trauma ED with greater than 120,000 annual visits. A convenience sample of patients was recruited. Adult, non-ambulance patients presenting with abdominal pain were eligible. Participants were randomized into experimental and control groups. Patients in the control group provided a urine sample after physician evaluation, if ordered by the provider. Patients in the experimental group were prompted to provide a urine sample in the triage restrooms immediately after screening at the greeter desk. The UA sample was transported to the treatment area and sent to the laboratory after physician evaluation. Results A total of 125 control patients and 124 experimental patients were enrolled. Forty-two patients were excluded because they were unable to provide a urine sample. Patients who had a urinalysis ordered were included in statistical analysis. Final data set included 65 patients in the experimental group and 96 patients in the control group. No significant difference (p=0.5072) in disposition time between subjects in the experimental group (n=65, mean=5:17 [hours:min]) and subjects in the control group (n=96, mean=5:30) was found. Conclusions The triage protocol for urine specimen collection did not significantly reduce ED TTD. Further research in overcrowded EDs with long patient waiting room times may benefit from implementing a triage protocol for urine specimen collection.",2020,No significant difference (p=0.5072) in disposition time between subjects in the experimental group,"['ambulatory patients with abdominal pain', 'Suburban Level One trauma ED with greater than 120,000 annual visits', '125 control patients and 124 experimental patients were enrolled', 'Patients who had a urinalysis ordered were included in statistical analysis', '65 patients in the experimental group and 96 patients in the control group', 'Emergency Department Time to Disposition', 'Forty-two patients were excluded because they were unable to provide a urine sample', 'Adult, non-ambulance patients presenting with abdominal pain were eligible']",['disposition (TTD'],"['disposition time', 'length of stay (LOS']","[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0042014', 'cui_str': 'Urinalysis'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0184758', 'cui_str': 'Patient disposition'}, {'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C1610733', 'cui_str': 'Urine specimen'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0002422', 'cui_str': 'Ambulance'}, {'cui': 'C0150312', 'cui_str': 'Present'}]","[{'cui': 'C0184758', 'cui_str': 'Patient disposition'}, {'cui': 'C0040223', 'cui_str': 'Time'}]","[{'cui': 'C0184758', 'cui_str': 'Patient disposition'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",42.0,0.060011,No significant difference (p=0.5072) in disposition time between subjects in the experimental group,"[{'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Bahl', 'Affiliation': 'Emergency Medicine, Beaumont Hospital, Royal Oak, USA.'}, {'ForeName': 'Ameen M', 'Initials': 'AM', 'LastName': 'Jamali', 'Affiliation': 'Emergency Medicine, Medical Center Health System, Odessa, USA.'}, {'ForeName': 'Gautam', 'Initials': 'G', 'LastName': 'Ramesh', 'Affiliation': 'Emergency Medicine, Michigan State University College of Human Medicine, Lansing, USA.'}]",Cureus,['10.7759/cureus.10495']
1805,33083301,"Efficacy of Pumpkin Ointment in Treatment of Chronic Hand Eczema: A Randomized, Active-Controlled, Double Blind Clinical Trial.","Background


Hand Eczema (HE) is chronic skin disease with a high prevalence in population. It has negative impact on the quality of life. Due to the public interest in herbal remedies, we attempt to assess the efficacy of pumpkin ointment in treatment of chronic HE in this research.
Methods


This study was conducted in an outpatient clinic at Imam-Khomeini Hospital in Tehran (Iran) from May 2015 to Nov 2016. We performed a double-blind trial on 60 patients with chronic HE randomized to four groups included pumpkin, betamethasone, eucerin and almond ointment (n=15 for each group) for 28 days. Patients were ordered to apply ointments twice a day. Hand Eczema Severity Index (HECSI) and Dermatology Life Quality Index (DLQI) of the patients were evaluated by a dermatologist on the 1st, 14th and 28th d after the start of treatment.
Results


Patients' DLQI scores in pumpkin and betamethasone group was significant and pumpkin group showed a better response in quality of life ( P =0.001). Betamethasone and pumpkin ointment were effective and showed significant improvement compared with almond and eucerin and reduce HECSI scores ( P =0.002 and  P =0.012 respectively). Betamethasone ointment outcome on HECSI scores in comparison with topical pumpkin was significant ( P <0.001). No clinically adverse effects were observed.
Conclusion


Although pumpkin ointment showed a better response in patients' DLQI in HE but it was less effective than betamethasone in decreasing HECSI.",2020,Betamethasone ointment outcome on HECSI scores in comparison with topical pumpkin was significant ( P <0.001).,"['outpatient clinic at Imam-Khomeini Hospital in Tehran (Iran) from May 2015 to Nov 2016', 'chronic skin disease with a high prevalence in population', 'Chronic Hand Eczema', '60 patients with chronic HE randomized to four groups included']","['pumpkin ointment', 'Pumpkin Ointment', 'betamethasone', 'pumpkin, betamethasone, eucerin and almond ointment', 'Betamethasone', 'Betamethasone and pumpkin ointment']","['Hand Eczema Severity Index (HECSI) and Dermatology Life Quality Index (DLQI', 'adverse effects', 'HECSI scores', 'quality of life', 'DLQI scores']","[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0521321', 'cui_str': 'Imam'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C1290009', 'cui_str': 'Chronic disease of skin'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1276092', 'cui_str': 'Chronic hand eczema'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0330477', 'cui_str': 'Genus Cucurbita'}, {'cui': 'C0028912', 'cui_str': 'Ointment'}, {'cui': 'C0005308', 'cui_str': 'Betamethasone'}, {'cui': 'C0164056', 'cui_str': 'eucerin'}, {'cui': 'C0440286', 'cui_str': 'Almond'}]","[{'cui': 'C0239816', 'cui_str': 'Hand eczema'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0451112', 'cui_str': 'Dermatology life quality index'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C4706308', 'cui_str': 'DLQI (Dermatology Life Quality Index) score'}]",60.0,0.140076,Betamethasone ointment outcome on HECSI scores in comparison with topical pumpkin was significant ( P <0.001).,"[{'ForeName': 'Alemeh', 'Initials': 'A', 'LastName': 'Khademi', 'Affiliation': 'Department of Traditional Medicine, School of Persian Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Parvin', 'Initials': 'P', 'LastName': 'Mansuri', 'Affiliation': 'Skin and Stem Cell Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Daryoush', 'Initials': 'D', 'LastName': 'Pahlevan', 'Affiliation': 'Research Center for Social Determinants of Health, Semnan University of Medical Sciences, Semnan, Iran.'}, {'ForeName': 'Mahbubeh', 'Initials': 'M', 'LastName': 'Bozorgi', 'Affiliation': 'Department of Traditional Pharmacy, School of Iranian Traditional Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Malihe', 'Initials': 'M', 'LastName': 'Nasiri', 'Affiliation': 'Department of Biostatistics, School of Paramedical, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Somayeh', 'Initials': 'S', 'LastName': 'Hejazi', 'Affiliation': 'Skin and Stem Cell Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Azizian', 'Affiliation': 'Department of Dermatology, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Laila', 'Initials': 'L', 'LastName': 'Shirbeigi', 'Affiliation': 'Department of Traditional Medicine, School of Persian Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}]",Iranian journal of public health,['10.18502/ijph.v49i7.3588']
1806,33083465,"Impact of Dexmedetomidine on Tourniquet-Induced Systemic Effects in Total Knee Arthroplasty under Spinal Anesthesia: a Prospective Randomized, Double-Blinded Study.","Background


Clinical studies on the impact of dexmedetomidine on tourniquet-induced systemic effects have been inconsistent. We investigated the impact of dexmedetomidine on tourniquet-induced systemic effects in total knee arthroplasty.
Methods


Eighty patients were randomly assigned to either control (CON) or dexmedetomidine (DEX) group. The DEX group received an intravenous loading dose of 0.5  μ g/kg DEX over 10 minutes, followed by a continuous infusion of 0.5  μ g/kg/h from 10 minutes before the start of surgery until completion. The CON group received the same calculated volume of normal saline. Pain outcomes and metabolic and coagulative changes after tourniquet application and after tourniquet release were investigated.
Results


The frequency of fentanyl administration postoperatively, patient-controlled analgesia (PCA) volume at 24 hours postoperatively, total PCA volume consumed in 48 hours postoperatively, and VAS score for pain at 24 and 48 hours postoperatively were significantly lower in the DEX group than in the CON group. Ten minutes after the tourniquet release, the DEX group showed significantly higher pH and lower lactate level than those in the CON group. Antithrombin III activity and body temperature 10 minutes after tourniquet release were significantly lower in the DEX group than in the CON group. Ca 2+ , K + , HCO 3   - , base excess, and PCO 2  levels 10 minutes after tourniquet release were not significantly different between the two groups.
Conclusion


We showed that DEX attenuated pain and hemodynamic, metabolic, and coagulative effects induced by the tourniquet. However, these metabolic and coagulative changes were within normal limits. Therefore, DEX could be used as an analgesic adjuvant, but should not be considered for routine use to prevent the systemic effects induced by tourniquet use.",2020,Antithrombin III activity and body temperature 10 minutes after tourniquet release were significantly lower in the DEX group than in the CON group.,"['Total Knee Arthroplasty under Spinal Anesthesia', 'Methods\n\n\nEighty patients', 'total knee arthroplasty']","['DEX', 'Dexmedetomidine', 'intravenous loading dose of 0.5\u2009 μ g/kg DEX', 'control (CON) or dexmedetomidine (DEX', 'dexmedetomidine', 'CON']","['Antithrombin III activity and body temperature 10 minutes after tourniquet release', 'Pain outcomes and metabolic and coagulative changes', 'VAS score for pain', 'frequency of fentanyl administration postoperatively, patient-controlled analgesia (PCA) volume', 'pain and hemodynamic, metabolic, and coagulative effects', 'total PCA volume', 'higher pH and lower lactate level']","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C1300563', 'cui_str': 'g/kg'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0200416', 'cui_str': 'Antithrombin III assay'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0412803', 'cui_str': 'Tourniquet release'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0860761', 'cui_str': 'pH high'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0428445', 'cui_str': 'D-lactate measurement'}]",80.0,0.102866,Antithrombin III activity and body temperature 10 minutes after tourniquet release were significantly lower in the DEX group than in the CON group.,"[{'ForeName': 'Cheol', 'Initials': 'C', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Wonkwang University School of Medicine, 895 Muwang-ro, Iksan, Jeonllabuk-do, 54538, Republic of Korea.'}, {'ForeName': 'Cheolhyeong', 'Initials': 'C', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Wonkwang University School of Medicine, 895 Muwang-ro, Iksan, Jeonllabuk-do, 54538, Republic of Korea.'}, {'ForeName': 'Cheolhwan', 'Initials': 'C', 'LastName': 'So', 'Affiliation': 'Department of Pediatrics, Wonkwang University School of Medicine, 895 Muwang-ro, Iksan, Jeonlabuk-do 54538, Republic of Korea.'}, {'ForeName': 'Jiheui', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Korea Cancer Center Hospital, 75 Nowon-ro, Nowon-gu, Seoul 01812, Republic of Korea.'}, {'ForeName': 'Insung', 'Initials': 'I', 'LastName': 'Choi', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Korea Cancer Center Hospital, 75 Nowon-ro, Nowon-gu, Seoul 01812, Republic of Korea.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Ma', 'Affiliation': 'Department of Orthopaedic Surgery, Hallym University Gangnam Sacred Heart Hospital, Seoul 07441, Republic of Korea.'}, {'ForeName': 'Jihyo', 'Initials': 'J', 'LastName': 'Hwang', 'Affiliation': 'Department of Orthopaedic Surgery, Hallym University Gangnam Sacred Heart Hospital, Seoul 07441, Republic of Korea.'}]",BioMed research international,['10.1155/2020/4208597']
1807,33083468,Effect of Dexmedetomidine on Postoperative Lung Injury during One-Lung Ventilation in Thoracoscopic Surgery.,"Objective


To investigate the effect of dexmedetomidine on postoperative lung injury in patients undergoing thoracoscopic surgery.
Methods


From March 2019 to October 2019, 40 patients were randomly divided into two groups: dexmedetomidine group (group D) and control group (group C). Except recording the general condition of the patients in both groups preoperatively and intraoperatively, the oxygenation index (OI) and alveolar-arterial oxygen partial pressure difference (A-aDO 2 ) were monitored at admission (T0), immediately after one-lung ventilation (T1), 0.5 h after one-lung ventilation (T2), and 15 minutes after inhaling air before leaving the room (T3). The content of IL-8 in arterial blood was measured by enzyme-linked immunosorbent assay (ELISA) at T0 and T2, and the expression of AQP1 protein in isolated lung tissue was measured by immunohistochemistry and Western blot. The incidence of postoperative pulmonary complications (atelectasis, pneumonia, and acute respiratory distress syndrome) was used as the index of lung injury.
Results


There was no significant difference in the general condition before and during operation between the two groups. There was no significant difference in arterial blood IL-8 content between the two groups at the T0 time point, but the arterial blood IL-8 content at the T2 time point was significantly higher than that at the T0 time point, especially in group C. The results of immunohistochemistry and Western blot showed that the expression level of AQP1 protein in the isolated lung tissue of group D was significantly higher than that of group C ( P  < 0 05). At T3, the OI of group D was significantly higher than that of group C, and the A-aDO 2  of group D was significantly lower than that of group C ( P  < 0.05). There was no significant difference in the incidence of postoperative PPCs between the two groups.
Conclusion


Dexmedetomidine can reduce the level of plasma IL-8 and upregulate the expression of AQP1 in the lung tissue of patients undergoing thoracoscopic surgery under one-lung ventilation, but it has no significant effect on the incidence of postoperative PPCs. Dexmedetomidine can be safely used in thoracoscopic surgery and has a certain protective effect on lung injury.",2020,"There was no significant difference in arterial blood IL-8 content between the two groups at the T0 time point, but the arterial blood IL-8 content at the T2 time point was significantly higher than that at the T0 time point, especially in group C.","['Methods\n\n\nFrom March 2019 to October 2019, 40 patients', 'patients undergoing thoracoscopic surgery', 'Thoracoscopic Surgery']","['Dexmedetomidine', 'dexmedetomidine']","['postoperative lung injury', 'postoperative pulmonary complications (atelectasis, pneumonia, and acute respiratory distress syndrome', 'expression level of AQP1 protein', 'content of IL-8 in arterial blood', 'arterial blood IL-8 content', 'oxygenation index (OI) and alveolar-arterial oxygen partial pressure difference (A-aDO 2 ', 'Postoperative Lung Injury', 'incidence of postoperative PPCs', 'level of plasma IL-8']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0751551', 'cui_str': 'Thoracoscopic Surgical Procedures'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0273115', 'cui_str': 'Injury of lung'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0004144', 'cui_str': 'Atelectasis'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0109329', 'cui_str': 'Aquaporin-1'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0229665', 'cui_str': 'Arterial blood'}, {'cui': 'C1278185', 'cui_str': 'Oxygenation index measurement'}, {'cui': 'C0202155', 'cui_str': 'Oxygen measurement, partial pressure, arterial'}, {'cui': 'C0001443', 'cui_str': 'Adenosine'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}]",40.0,0.0167799,"There was no significant difference in arterial blood IL-8 content between the two groups at the T0 time point, but the arterial blood IL-8 content at the T2 time point was significantly higher than that at the T0 time point, especially in group C.","[{'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Meng', 'Affiliation': 'Department of Cardiovascular Surgery, First Affiliated Hospital of Kunming Medical University, Kunming 650032, China.'}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Lv', 'Affiliation': 'Department of Anaesthesiology, First Affiliated Hospital of Kunming Medical University, Kunming 650032, China.'}, {'ForeName': 'Jiaxiang', 'Initials': 'J', 'LastName': 'Yao', 'Affiliation': 'Department of Anaesthesiology, First Affiliated Hospital of Kunming Medical University, Kunming 650032, China.'}, {'ForeName': 'Siyu', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Department of Anaesthesiology, First Affiliated Hospital of Kunming Medical University, Kunming 650032, China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Yang', 'Affiliation': 'Department of Anaesthesiology, First Affiliated Hospital of Kunming Medical University, Kunming 650032, China.'}]",BioMed research international,['10.1155/2020/4976205']
1808,33083487,"Effects of Deep Cervical Flexor Training on Forward Head Posture, Neck Pain, and Functional Status in Adolescents Using Computer Regularly.","In contemporary societies, computer use by children is a necessity and thus highly prevalent. Using computers for long hours is related to a higher risk of computer-related muscular disorders like forward head posture (FHP) and neck pain (NP). Deep cervical flexor (DCF) muscles are important head-on-neck posture stabilizers; thus, their training may lead to an improvement in FHP and NP. The aim of this study was to determine if 4 weeks of DCF training is effective in alleviating NP, improving FHP, and functional status in adolescent children using computers regularly, a pretest-posttest experimental group design was used. Subjects were randomly assigned into the experimental group (receiving DCF training and postural education) and the control group (receiving postural education only). 30 subjects with a mean age of 15.7 ± 1.725 years with NP and FHP using computers regularly participated in the study. Dependent variables were measured on day 1 (at baseline) and after 4 weeks of training. Photographic analysis was used for measuring FHP, visual analog scale for NP intensity, and neck disability index for functional status. Data analysis showed that in both groups, no significant improvement occurred in FHP. In both groups, there was a significant improvement in functional status and NP. There was no significant difference between both groups for FHP and NP. There was a significant improvement in functional status in the experimental group in comparison to the control group. Four weeks of DCF training does not cause a significant improvement in FHP in 13 to 18 years old adolescent children using computers regularly.",2020,Four weeks of DCF training does not cause a significant improvement in FHP in 13 to 18 years old adolescent children using computers regularly.,"['30 subjects with a mean age of 15.7 ± 1.725 years with NP and FHP using computers regularly participated in the study', 'Adolescents Using Computer Regularly', 'adolescent children', '18 years old adolescent children']","['Deep Cervical Flexor Training', 'DCF training and postural education) and the control group (receiving postural education only', 'DCF training']","['Forward Head Posture, Neck Pain, and Functional Status', 'alleviating NP, improving FHP, and functional status', 'functional status and NP', 'FHP, visual analog scale for NP intensity, and neck disability index for functional status', 'functional status', 'FHP']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0439780', 'cui_str': 'Forward'}, {'cui': 'C1536116', 'cui_str': 'Head posture abnormal'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0439780', 'cui_str': 'Forward'}, {'cui': 'C1536116', 'cui_str': 'Head posture abnormal'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",30.0,0.0172013,Four weeks of DCF training does not cause a significant improvement in FHP in 13 to 18 years old adolescent children using computers regularly.,"[{'ForeName': 'Isha', 'Initials': 'I', 'LastName': 'Sikka', 'Affiliation': 'Optum, Noida 201304, India.'}, {'ForeName': 'Chandan', 'Initials': 'C', 'LastName': 'Chawla', 'Affiliation': 'Ability Physiotherapy and Sports Injury Clinic, Hauz Khas, New Delhi 110016, India.'}, {'ForeName': 'Shveta', 'Initials': 'S', 'LastName': 'Seth', 'Affiliation': 'AIIMS, New Delhi 110029, India.'}, {'ForeName': 'Ahmad H', 'Initials': 'AH', 'LastName': 'Alghadir', 'Affiliation': 'Rehabilitation Research Chair, College of Applied Medical Sciences, King Saud University, P.O. Box 10219, Riyadh 11433, Saudi Arabia.'}, {'ForeName': 'Masood', 'Initials': 'M', 'LastName': 'Khan', 'Affiliation': 'Rehabilitation Research Chair, College of Applied Medical Sciences, King Saud University, P.O. Box 10219, Riyadh 11433, Saudi Arabia.'}]",BioMed research international,['10.1155/2020/8327565']
1809,33083489,"Efficacy of Curcumin Gel on Zinc, Magnesium, Copper, IL-1 β , and TNF- α  in Chronic Periodontitis Patients.","Curcumin exhibits antibacterial, antioxidant, and anti-inflammatory effects and has been suggested as a treatment for inflammatory diseases. The study is aimed at evaluating the effect of curcumin gel on serum levels of micronutrients (zinc, copper, and magnesium) and proinflammatory cytokines (IL-1 β  and TNF- α ) in chronic periodontitis patients. Ninety subjects with an age of 25-54 were included in this study. From the total number, 30 subjects with healthy periodontium (control group) (mean age = 37.30 ± 7.08) were employed for the sole purpose of obtaining the normal mean values of clinical, chemical, and immunological parameters, and 60 with chronic periodontitis (mean age = 36.73 ± 6.22) were divided randomly into 2 groups, of which each group included 30 subjects. Group A received scaling and root planing SRP and curcumin gel injection covered by Coe pack for 7 days, and group B received SRP alone covered by Coe pack. Clinical parameters (plaque index, gingival index, bleeding on probing, pocket depth, and clinical attachment loss measurements) and blood samples were collected before and after 1 month of treatment to measure serum levels of zinc, copper, magnesium, IL-1 β , and TNF- α . The results showed significant micronutrient alteration and increase of proinflammatory cytokines in the chronic periodontitis group as compared to healthy control ( P  ≤ 0.05), and curcumin gel had a significant effect on the reduction of IL-1 β , TNF- α , copper, and clinical parameters ( P  ≤ 0.05) and increase of zinc and magnesium levels after 1 month as compared to baseline ( P  ≤ 0.05), nearly the same pattern for group B but with nonsignificant differences for Zn ( P  > 0.05). In conclusion, curcumin gel resulted in a more significant reduction in clinical parameters, inflammatory mediators, and copper and increase of zinc and magnesium levels as compared to SRP alone.",2020,"The results showed significant micronutrient alteration and increase of proinflammatory cytokines in the chronic periodontitis group as compared to healthy control ( P  ≤ 0.05), and curcumin gel had a significant effect on the reduction of IL-1 β , TNF- α , copper, and clinical parameters ( P  ≤ 0.05) and increase of zinc and magnesium levels after 1 month as compared to baseline ( P  ≤ 0.05), nearly the same pattern for group B but with nonsignificant differences for Zn ( P  > 0.05).","['Chronic Periodontitis Patients', 'Ninety subjects with an age of 25-54 were included in this study', 'chronic periodontitis patients', '30 subjects with healthy periodontium (control group) (mean\u2009age = 37.30 ± 7.08) were employed for the sole purpose of obtaining the normal mean values of clinical, chemical, and immunological parameters, and 60 with chronic periodontitis (mean\u2009age = 36.73 ± 6.22']","['scaling and root planing SRP and curcumin gel injection covered by Coe pack', 'curcumin gel', 'SRP alone covered by Coe pack', 'Curcumin Gel']","['Zinc, Magnesium, Copper, IL-1 β , and TNF- α', 'serum levels of zinc, copper, magnesium, IL-1 β , and TNF- α ', 'reduction of IL-1 β , TNF- α , copper, and clinical parameters', 'proinflammatory cytokines', 'clinical parameters, inflammatory mediators, and copper and increase of zinc and magnesium levels', 'zinc and magnesium levels', 'Clinical parameters (plaque index, gingival index, bleeding on probing, pocket depth, and clinical attachment loss measurements) and blood samples', 'serum levels of micronutrients (zinc, copper, and magnesium) and proinflammatory cytokines (IL-1 β  and TNF- α ']","[{'cui': 'C0266929', 'cui_str': 'Chronic periodontitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0031093', 'cui_str': 'Periodontal ligament'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517856', 'cui_str': '7.08'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}, {'cui': 'C1285529', 'cui_str': 'Purpose'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0220806', 'cui_str': 'Chemical'}, {'cui': 'C0205470', 'cui_str': 'Immunologic'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]","[{'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0085287', 'cui_str': 'Root planing of tooth'}, {'cui': 'C0074512', 'cui_str': 'SRP (Signal Recognition Particle)'}, {'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0184967', 'cui_str': 'Insertion of pack'}]","[{'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0009968', 'cui_str': 'Copper'}, {'cui': 'C0021755', 'cui_str': 'Interleukin-1'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0202125', 'cui_str': 'Magnesium measurement, serum'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0040577', 'cui_str': 'Trace element'}]",90.0,0.0427928,"The results showed significant micronutrient alteration and increase of proinflammatory cytokines in the chronic periodontitis group as compared to healthy control ( P  ≤ 0.05), and curcumin gel had a significant effect on the reduction of IL-1 β , TNF- α , copper, and clinical parameters ( P  ≤ 0.05) and increase of zinc and magnesium levels after 1 month as compared to baseline ( P  ≤ 0.05), nearly the same pattern for group B but with nonsignificant differences for Zn ( P  > 0.05).","[{'ForeName': 'Chenar Anwar', 'Initials': 'CA', 'LastName': 'Mohammad', 'Affiliation': 'Department of Periodontology, College of Dentistry, Hawler Medical University, Erbil, Kurdistan Region, Iraq.'}]",BioMed research international,['10.1155/2020/8850926']
1810,33083515,"Safety, pharmacokinetics, and pharmacodynamics of Gln-1062, a prodrug of galantamine.","Introduction


Gln-1062 (MEMOGAIN) is an intranasally administered lipophilic prodrug of galantamine. Based on high brain-to-blood concentrations observed in pre-clinical studies, Gln-1062 is expected to have superior cognitive efficacy compared to oral galantamine.
Methods


Forty-eight healthy elderly subjects were randomized 12:4 to Gln-1062 (5.5, 11, or 22 mg, b.i.d., for 7 days) or placebo. Safety, tolerability, pharmacokinetics, and pharmacodynamics were assessed repeatedly. Pharmacokinetics were compared with 16 mg oral galantamine.
Results


Gln-1062 up to 22 mg, b.i.d., was well tolerated. Gln-1062 plasma concentrations increased immediately following dosing (median T max  of 0.5 hour [range 0.5-1.0]). C max  and AUC 0-last  increased in a dose-linear manner over all three dose levels. Gln-1062 was rapidly cleaved into galantamine. Gln-1062 significantly improved adaptive tracking (sustained attention) with 1.95% (95% confidence interval [CI] 0.630-3.279,  P  = 0.0055) compared to placebo after correction for individual baseline performance.
Discussion


Gln-1062 was considered to be safe and caused fewer gastrointestinal side effects than oral galantamine. Gln-1062 behaved pharmacokinetically as expected and improved performance on cognitive tests.",2020,"Gln-1062 significantly improved adaptive tracking (sustained attention) with 1.95% (95% confidence interval [CI] 0.630-3.279,  P  = 0.0055) compared to placebo after correction for individual baseline performance.
",['Methods\n\n\nForty-eight healthy elderly subjects'],"['galantamine', 'placebo']","['Safety, pharmacokinetics, and pharmacodynamics', 'Gln-1062 plasma concentrations', 'Safety, tolerability, pharmacokinetics, and pharmacodynamics', 'tolerated', 'adaptive tracking (sustained attention', 'C max  and AUC 0-last']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0016967', 'cui_str': 'Galantamine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C2933307', 'cui_str': 'memogain'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0589099', 'cui_str': 'Sustained attention'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}]",48.0,0.0305928,"Gln-1062 significantly improved adaptive tracking (sustained attention) with 1.95% (95% confidence interval [CI] 0.630-3.279,  P  = 0.0055) compared to placebo after correction for individual baseline performance.
","[{'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Bakker', 'Affiliation': 'Centre for Human Drug Research Leiden The Netherlands.'}, {'ForeName': 'Jasper', 'Initials': 'J', 'LastName': 'van der Aart', 'Affiliation': 'Centre for Human Drug Research Leiden The Netherlands.'}, {'ForeName': 'Ellen P', 'Initials': 'EP', 'LastName': 'Hart', 'Affiliation': 'Centre for Human Drug Research Leiden The Netherlands.'}, {'ForeName': 'Erica S', 'Initials': 'ES', 'LastName': 'Klaassen', 'Affiliation': 'Centre for Human Drug Research Leiden The Netherlands.'}, {'ForeName': 'Kirsten R', 'Initials': 'KR', 'LastName': 'Bergmann', 'Affiliation': 'Centre for Human Drug Research Leiden The Netherlands.'}, {'ForeName': 'Michiel J', 'Initials': 'MJ', 'LastName': 'van Esdonk', 'Affiliation': 'Centre for Human Drug Research Leiden The Netherlands.'}, {'ForeName': 'Denis G', 'Initials': 'DG', 'LastName': 'Kay', 'Affiliation': 'Alpha Cognition Inc Vancouver BC Canada.'}, {'ForeName': 'Geert Jan', 'Initials': 'GJ', 'LastName': 'Groeneveld', 'Affiliation': 'Centre for Human Drug Research Leiden The Netherlands.'}]","Alzheimer's & dementia (New York, N. Y.)",['10.1002/trc2.12093']
1811,33083523,Subthalamic deep brain stimulation improves sleep and excessive sweating in Parkinson's disease.,"Parkinson's disease (PD) is a complex multisystem disorder with motor and non-motor symptoms (NMS). NMS may have an even greater impact on quality of life than motor symptoms. Subthalamic nucleus deep brain stimulation (STN-DBS) has been shown to improve motor fluctuations and quality of life, whereas the effects on different NMS have been less examined. Sleep disturbances and autonomic dysfunction are among the most prevalent NMS. We here report the efficacy of STN-DBS on sleep disturbances and autonomic dysfunction. In the parent trial, 60 patients were included in a single-center randomized prospective study, with MDS-UPDRS III and PDQ-39 as primary endpoints at 12 months of STN-DBS. Preplanned assessments at baseline and postoperatively at 3 and 12 months also included Parkinson's Disease Sleep Scale (PDSS); Scopa-Aut; and MDS-UPDRS I, II, and IV. We found that STN-DBS had a significant and lasting positive effect on overall sleep quality, nocturnal motor symptoms and restlessness, and daytime dozing. Several aspects of autonomic dysfunction were also improved at 3 months postoperatively, although at 12 months only thermoregulation (sudomotor symptoms) remained significantly improved. We could not identify preoperative factors that predicted improvement in PDSS or Scopa-Aut. There was a close relationship between improved autonomic symptoms and improved quality of life after 1 year. NMS and especially sleep and autonomic dysfunction deserve more focus to improve patient outcomes further.",2020,"We found that STN-DBS had a significant and lasting positive effect on overall sleep quality, nocturnal motor symptoms and restlessness, and daytime dozing.","['60 patients', ""Parkinson's disease""]","['MDS-UPDRS III and PDQ-39', 'Subthalamic deep brain stimulation', 'NMS', 'STN-DBS', 'Subthalamic nucleus deep brain stimulation (STN-DBS']","['overall sleep quality, nocturnal motor symptoms and restlessness, and daytime dozing', 'autonomic dysfunction', 'sleep and excessive sweating', 'Sleep disturbances and autonomic dysfunction', 'sleep disturbances and autonomic dysfunction', 'autonomic symptoms and improved quality of life', 'motor fluctuations and quality of life', 'quality of life', ""Parkinson's Disease Sleep Scale (PDSS); Scopa-Aut; and MDS-UPDRS""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}]","[{'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}, {'cui': 'C0426980', 'cui_str': 'Motor symptoms'}, {'cui': 'C0152355', 'cui_str': 'Nucleus of Luys'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0426980', 'cui_str': 'Motor symptoms'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0013363', 'cui_str': 'Dysautonomia'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0020458', 'cui_str': 'Hyperhidrosis'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1868976', 'cui_str': 'Motor fluctuations'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0004348', 'cui_str': 'Austria'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}]",60.0,0.0200891,"We found that STN-DBS had a significant and lasting positive effect on overall sleep quality, nocturnal motor symptoms and restlessness, and daytime dozing.","[{'ForeName': 'Silje', 'Initials': 'S', 'LastName': 'Bjerknes', 'Affiliation': 'Department of Neurology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Inger Marie', 'Initials': 'IM', 'LastName': 'Skogseid', 'Affiliation': 'Department of Neurology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Tuva Jin', 'Initials': 'TJ', 'LastName': 'Hauge', 'Affiliation': 'Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Espen', 'Initials': 'E', 'LastName': 'Dietrichs', 'Affiliation': 'Department of Neurology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Toft', 'Affiliation': 'Department of Neurology, Oslo University Hospital, Oslo, Norway.'}]",NPJ Parkinson's disease,['10.1038/s41531-020-00131-0']
1812,33083554,Safety of eyeglasses wear for visual acuity among middle school students in northwestern rural China: a cluster-randomised controlled trial.,"Objective


To assess the effect of free eyeglasses provision on visual acuity among middle school students in northwestern rural China.
Methods and analysis


Among 31 middle schools randomly selected from 47 middle schools in northwestern rural China, students were randomly allocated by school to one of two interventions: free eyeglasses (intervention group), and eyeglasses prescriptions given only to the parents (control group). The main outcome of this study is uncorrected visual acuity after 9 months, adjusted for baseline visual acuity.
Results


Among 2095 students from 31 middle schools, 995 (47.5%) failed the visual acuity screening, 515 (51.8%, 15 schools) of which were randomly assigned to the intervention group, with the remaining 480 students (48.2%, 16 schools) assigned to the control group. Among these, a total of 910 students were followed up and analysed. Endline eyeglasses wear in the intervention group was 44%, and 36% in the control group. Endline visual acuity of students in the intervention group was significantly better than students in the control group, adjusting for other variables (0.045 LogMAR units, 95% CI 0.006 to 0.084, equivalent to 0.45 lines, p=0.027), and insignificantly better only for baseline visual acuity (difference of 0.008 LogMAR units, 95% CI -0.018 to 0.034, equivalent to 0.08 lines).
Conclusion


We found no evidence that receiving free eyeglasses worsened visual acuity among middle school students in northwestern rural China.
Trial registration number


ISRCTN17141957.",2020,"Endline visual acuity of students in the intervention group was significantly better than students in the control group, adjusting for other variables (0.045 LogMAR units, 95% CI 0.006 to 0.084, equivalent to 0.45 lines, p=0.027), and insignificantly better only for baseline visual acuity (difference of 0.008 LogMAR units, 95% CI -0.018 to 0.034, equivalent to 0.08 lines).
","['31 middle schools randomly selected from 47 middle schools in northwestern rural China, students', 'middle school students in northwestern rural China', '2095 students from 31 middle schools, 995 (47.5%) failed the visual acuity screening, 515 (51.8%, 15 schools) of which were randomly assigned to the intervention group, with the remaining 480 students (48.2%, 16 schools) assigned to the control group']","['free eyeglasses (intervention group), and eyeglasses prescriptions given only to the parents (control group', 'free eyeglasses provision']","['baseline visual acuity', 'visual acuity', 'Endline visual acuity', 'uncorrected visual acuity']","[{'cui': 'C0557797', 'cui_str': 'Middle school'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4319609', 'cui_str': '480'}, {'cui': 'C5191314', 'cui_str': '48.2'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0419275', 'cui_str': 'Prescription of spectacles'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C1637380', 'cui_str': 'Uncorrected visual acuity'}]",910.0,0.224201,"Endline visual acuity of students in the intervention group was significantly better than students in the control group, adjusting for other variables (0.045 LogMAR units, 95% CI 0.006 to 0.084, equivalent to 0.45 lines, p=0.027), and insignificantly better only for baseline visual acuity (difference of 0.008 LogMAR units, 95% CI -0.018 to 0.034, equivalent to 0.08 lines).
","[{'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': 'Rural Education Action Program, Stanford University Freeman Spogli Institute for International Studies, Stanford, California, USA.'}, {'ForeName': 'Xinwu', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ""School of Public Administration, Northwest University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Haoyang', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Rural Education Action Program, Stanford University Freeman Spogli Institute for International Studies, Stanford, California, USA.'}, {'ForeName': 'Xiaochen', 'Initials': 'X', 'LastName': 'Ma', 'Affiliation': 'China Center for Health Development Studies, Peking University, Beijing, China.'}, {'ForeName': 'Dimitris', 'Initials': 'D', 'LastName': 'Friesen', 'Affiliation': 'Rural Education Action Program, Stanford University Freeman Spogli Institute for International Studies, Stanford, California, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Rozelle', 'Affiliation': 'Rural Education Action Program, Stanford University Freeman Spogli Institute for International Studies, Stanford, California, USA.'}, {'ForeName': 'Xiaopeng', 'Initials': 'X', 'LastName': 'Pang', 'Affiliation': 'School of Agricultural Economics and Rural Development, Renmin University of China, Beijing, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Zhou', 'Affiliation': ""School of Public Administration, Northwest University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Congdon', 'Affiliation': 'Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, Guangdong, China.'}]",BMJ open ophthalmology,['10.1136/bmjophth-2020-000572']
1813,33090368,Neuromagnetic Amygdala Response to Pain-Related Fear as a Brain Signature of Fibromyalgia.,"INTRODUCTION


Fibromyalgia (FM) is a chronic pain condition characterized by impaired emotional regulation. This study explored the brain response to pain-related fear as a potential brain signature of FM.
METHODS


We used a conditioned fear task and magnetoencephalography to record pain-related fear responses in patients with FM. Two blocks of 30 fear responses were collected to compute the response strength in the first block and the strength difference between the first and second blocks (fear habituation). These measurements were investigated for their clinical relevance and compared with measurements obtained from healthy controls and patients with chronic migraine (CM), a different chronic pain condition often comorbid with FM.
RESULTS


Pain-related fear clearly activated the bilateral amygdala and anterior insula in patients with FM (n = 52), patients with CM (n = 50), and the controls (n = 30); the response strength in the first block was consistent across groups. However, fear habituation in the right amygdala decreased in the FM group (vs. CM and control groups, both p ≤ 0.001, no difference between CM and control groups). At the 3-month follow-up, the patients with FM reporting < 30% improvement in pain severity (n = 15) after pregabalin treatment exhibited lower fear habituation in the left amygdala at baseline (vs. ≥ 30% improvement, n = 22, p = 0.019). Receiver operating characteristic analysis confirmed that amygdala fear habituation is a suitable predictor of diagnosis and treatment outcomes of FM (area under the curve > 0.7).
CONCLUSIONS


Amygdala activation to pain-related fear is maladaptive and linked to treatment outcomes in patients with FM. Because the aberrant amygdala response was not observed in the CM group, this response is a potential brain signature of FM.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier, NCT02747940.",2020,"RESULTS


Pain-related fear clearly activated the bilateral amygdala and anterior insula in patients with FM (n = 52), patients with CM (n = 50), and the controls (n = 30); the response strength in the first block was consistent across groups.","['healthy controls and patients with chronic migraine (CM), a different chronic pain condition often comorbid with FM', 'patients with FM']",['conditioned fear task and magnetoencephalography'],"['fear habituation in the right amygdala', 'response strength', 'fear habituation', 'aberrant amygdala response', 'pain severity']","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1960870', 'cui_str': 'Transformed migraine'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}]","[{'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0024489', 'cui_str': 'Magnetoencephalography'}]","[{'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0013170', 'cui_str': 'Drug habituation'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid structure'}, {'cui': 'C0443127', 'cui_str': 'Aberrant'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",,0.0711474,"RESULTS


Pain-related fear clearly activated the bilateral amygdala and anterior insula in patients with FM (n = 52), patients with CM (n = 50), and the controls (n = 30); the response strength in the first block was consistent across groups.","[{'ForeName': 'Fu-Jung', 'Initials': 'FJ', 'LastName': 'Hsiao', 'Affiliation': 'Brain Research Center, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Wei-Ta', 'Initials': 'WT', 'LastName': 'Chen', 'Affiliation': 'Brain Research Center, National Yang-Ming University, Taipei, Taiwan. wtchen@vghtpe.gov.tw.'}, {'ForeName': 'Yu-Chieh', 'Initials': 'YC', 'LastName': 'Ko', 'Affiliation': 'School of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Hung-Yu', 'Initials': 'HY', 'LastName': 'Liu', 'Affiliation': 'School of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Yen-Feng', 'Initials': 'YF', 'LastName': 'Wang', 'Affiliation': 'School of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Shih-Pin', 'Initials': 'SP', 'LastName': 'Chen', 'Affiliation': 'Brain Research Center, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Kuan-Lin', 'Initials': 'KL', 'LastName': 'Lai', 'Affiliation': 'School of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Hsiao-Yi', 'Initials': 'HY', 'LastName': 'Lin', 'Affiliation': 'Department of Allergy, Immunology and Rheumatology, Cheng Hsin General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Coppola', 'Affiliation': 'Department of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome Polo Pontino, Latina, Italy.'}, {'ForeName': 'Shuu-Jiun', 'Initials': 'SJ', 'LastName': 'Wang', 'Affiliation': 'Brain Research Center, National Yang-Ming University, Taipei, Taiwan. sjwang@vghtpe.gov.tw.'}]",Pain and therapy,['10.1007/s40122-020-00206-z']
1814,33090380,Neuroprotective role of phosphoserine in primary open-angle glaucoma patients.,"OBJECTIVE


To evaluate the neuroprotective role of phosphoserine (P-Ser) in primary open-angle glaucoma (POAG) patients and to compare its therapeutic effectiveness to placebo treatment.
PATIENTS AND METHODS


Fifty-one patients (24 males and 27 females) between 35 and 61 years (average 46 years ± 3.8 SD) affected by POAG were enrolled in this study. Patients were divided in two groups: group A included 28 subjects that received an oral P-Ser treatment for 12 months; and group B included 23 subjects that received an oral placebo treatment for 12 months. Complete ophthalmological examination, standard automated perimetric examination, analysis of ON fibers via scanning laser polarimetry and glaucoma staging was performed in all patients at enrolment and 1, 3, 6, and 12 months after. Statistical analysis was performed using STATA 14.0 (Collage Station, TX, USA).
RESULTS


Mean deviation (MD) and pattern standard deviation (PSD) analysis by means of 30-2 full threshold of the visual fields (VFs), retinal nerve fiber layer (RNFL) thickness by means of GDx, and IOP were considered to evaluate P-Ser therapy effectiveness in both groups. A statistically significant improvement (p<0.05) in VF, RNFL thickness and IOP compared to pre-treatment was found in patients in group A.
CONCLUSIONS


Our study shows a significant improvement in several variables in patients with glaucoma treated with P-Ser compared to placebo and suggests a potential neuroprotective effect of P-Ser in treating glaucoma patients in association with the traditional hypotonic topical therapy.",2020,"A statistically significant improvement (p<0.05) in VF, RNFL thickness and IOP compared to pre-treatment was found in patients in group A.
CONCLUSIONS


","['Fifty-one patients (24 males and 27 females) between 35 and 61 years (average 46 years ± 3.8 SD) affected by POAG were enrolled in this study', 'primary open-angle glaucoma patients', 'primary open-angle glaucoma (POAG) patients', 'patients with glaucoma']","['oral placebo', 'phosphoserine', 'placebo', 'phosphoserine (P-Ser', 'oral P-Ser treatment']","['Mean deviation (MD) and pattern standard deviation (PSD) analysis by means of 30-2 full threshold of the visual fields (VFs), retinal nerve fiber layer (RNFL', 'VF, RNFL thickness and IOP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0339573', 'cui_str': 'Primary open angle glaucoma'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0031721', 'cui_str': 'Phosphoserine'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C1828170', 'cui_str': 'Mean deviation'}, {'cui': 'C1720055', 'cui_str': 'Pattern standard deviation'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0042826', 'cui_str': 'Visual field'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C1720466', 'cui_str': 'Nerve fiber layer'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0578862', 'cui_str': 'Intraocular pressure finding'}]",,0.0347308,"A statistically significant improvement (p<0.05) in VF, RNFL thickness and IOP compared to pre-treatment was found in patients in group A.
CONCLUSIONS


","[{'ForeName': 'S Z', 'Initials': 'SZ', 'LastName': 'Scalinci', 'Affiliation': 'Department of Medical and Surgical Sciences (DIMEC) University of Bologna, Bologna, Italy. t.samanta@yahoo.it.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Lugaresi', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Scorolli', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ralli', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Greco', 'Affiliation': ''}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Pantaleone', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Taurone', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Franzone', 'Affiliation': ''}]",European review for medical and pharmacological sciences,['10.26355/eurrev_202010_23186']
1815,33090465,"Lost in Translation: True Clinical Impact of RCM Overlooked in ""Biopsy outperforms Reflectance Confocal Microscopy in Diagnosing and Subtyping Basal Cell Carcinoma: Results and Experiences from a Randomized Controlled Multicentre Trial"".","In 'Biopsy Outperforms Reflectance Confocal Microscopy in Diagnosing and Subtyping Basal Cell Carcinoma: Results and Experiences from a Randomized Controlled Multicentre Trial', the authors found that reflectance confocal microscopy (RCM) identifies basal cell carcinoma (BCC) with 99% sensitivity and, impressively, distinguishes superficial BCCs from more aggressive BCCs with 88.9% sensitivity compared to punch biopsy (PB) at 91%, 1  a difference without statistical significance.",2020,"In 'Biopsy Outperforms Reflectance Confocal Microscopy in Diagnosing and Subtyping Basal Cell Carcinoma: Results and Experiences from a Randomized Controlled Multicentre Trial', the authors found that reflectance confocal microscopy (RCM) identifies basal cell carcinoma (BCC) with 99% sensitivity and, impressively, distinguishes superficial BCCs from more aggressive BCCs with 88.9% sensitivity compared to punch biopsy (PB) at 91%, 1  a difference without statistical significance.",['Lost in Translation'],['Biopsy Outperforms Reflectance Confocal Microscopy'],[],"[{'cui': 'C0040712', 'cui_str': 'Translations'}]","[{'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0242842', 'cui_str': 'Confocal Microscopy'}]",[],,0.0664728,"In 'Biopsy Outperforms Reflectance Confocal Microscopy in Diagnosing and Subtyping Basal Cell Carcinoma: Results and Experiences from a Randomized Controlled Multicentre Trial', the authors found that reflectance confocal microscopy (RCM) identifies basal cell carcinoma (BCC) with 99% sensitivity and, impressively, distinguishes superficial BCCs from more aggressive BCCs with 88.9% sensitivity compared to punch biopsy (PB) at 91%, 1  a difference without statistical significance.","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Gill', 'Affiliation': 'Department of Pathology, SUNY Downstate Medical Center, Brooklyn, NY, USA.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Pellacani', 'Affiliation': 'Department of Dermatology, University of Modena and Reggio Emilia, Modena, Italy.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Grant-Kels', 'Affiliation': 'Dermatology Department, University of Connecticut Health Center, Farmington, Connecticut, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ardigò', 'Affiliation': 'San Gallicano Institute IRCCS, Rome, Italy.'}, {'ForeName': 'C-S J', 'Initials': 'CJ', 'LastName': 'Chen', 'Affiliation': 'Dermatology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Gonzalez', 'Affiliation': 'Faculty of Medicine and Health Sciences, University of Alcala de Henares, Madrid, Spain.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Guitera', 'Affiliation': 'Sydney Melanoma Diagnostics Centre, Royal Prince Alfred Hospital, Camperdown, NSW, Australia.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Longo', 'Affiliation': 'Centro Oncologico ad Alta Tecnologia Diagnostica, Azienda Unità Sanitaria Locale-Istituto di Ricovero e Cura a Carattere Scientifico di Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Malvehy', 'Affiliation': ""Melanoma Unit, Dermatology Department, Hospital Clinic, Universitat de Barcelona, Institut d'investigacions biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.""}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Markowitz', 'Affiliation': 'Icahn School of Medicine, Kimberly and Eric J, Waldman Department of Dermatology, Mount Sinai Hospital System, New York, NY.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Puig', 'Affiliation': ""Melanoma Unit, Dermatology Department, Hospital Clinic, Universitat de Barcelona, Institut d'investigacions biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.""}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Rabinovitz', 'Affiliation': 'Skin and Cancer Associates, Plantation, Florida, USA.'}, {'ForeName': 'B K', 'Initials': 'BK', 'LastName': 'Rao', 'Affiliation': 'Departments of Dermatology and Pathology, Rutgers Robert Wood Johnson Medical School, Somerset.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Scope', 'Affiliation': 'The Kittner Skin Cancer Screening & Research Institute, Sheba Medical Center, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ulrich', 'Affiliation': 'CMB Collegium Medicum Berlin, Berlin, Germany.'}]",The British journal of dermatology,['10.1111/bjd.19602']
1816,33090505,Family monetary incentives as a value-based care model for oral hygiene: rationale and design of the BEhavioral EConomics for Oral health iNnovation (BEECON) trial.,"BACKGROUND


Effective prevention-focused, value-based strategies are needed to improve oral health. Despite evidence that monetary incentives can motivate healthy behavior, well-powered studies have yet to examine incentives for improving children's oral hygiene.
AIM


Describe the rationale and design of the BEhavioral EConomics for Oral health iNnovation (BEECON) trial, which tests lottery-based monetary incentives as a consumer-oriented, value-based care model for improving children's oral hygiene.
DESIGN


Phase II, stratified, permuted block randomized, controlled, two-arm, parallel groups, prevention trial.
SETTING


Study visits occur at three Los Angeles, CA health clinics.
PARTICIPANTS


Two hundred and forty-four parent-child dyads with a child aged 6-48 months.
INTERVENTIONS


Eligible dyads were randomized in equal allocation to one of two groups: lottery incentive group or waitlist (delayed incentive) control group. Weekly lottery incentives were offered for 6 months based on Bluetooth-recorded toothbrushing frequency. Both groups received weekly text message feedback on toothbrushing performance.
OUTCOMES


The primary outcome was toothbrushing performance from baseline to 6 months, measured as the mean number of qualifying half-day Bluetooth-recorded episodes per week when the child's teeth were brushed. Secondary outcomes included toothbrushing performance sustainability through 12 months and dental caries status.
CONCLUSIONS


BEECON offers a consumer-oriented approach to promoting value-based oral health care. We hypothesize that lottery-based incentives can improve oral hygiene in young children. Study results will inform programming efforts to enhance oral disease prevention in young children.
TRIAL REGISTRATION


ClinicalTrials.gov identifier NCT03576326.",2020,"The primary outcome was toothbrushing performance from baseline to 6 months, measured as the mean number of qualifying half-day Bluetooth-recorded episodes per week when the child's teeth were brushed.","['young children', 'Two hundred and forty-four parent-child dyads with a child aged 6-48\u2009months', 'Study visits occur at three Los Angeles, CA health clinics', ""children's oral hygiene""]","['lottery incentive group or waitlist (delayed incentive) control group', 'weekly text message feedback']","['oral hygiene', 'toothbrushing performance sustainability through 12\u2009months and dental caries status', 'toothbrushing performance from baseline to 6\u2009months, measured as the mean number of qualifying half-day Bluetooth-recorded episodes']","[{'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C4517660', 'cui_str': '244'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0029164', 'cui_str': 'Dental Hygiene'}]","[{'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]","[{'cui': 'C0029164', 'cui_str': 'Dental Hygiene'}, {'cui': 'C0183975', 'cui_str': 'Toothbrush'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}]",,0.0880776,"The primary outcome was toothbrushing performance from baseline to 6 months, measured as the mean number of qualifying half-day Bluetooth-recorded episodes per week when the child's teeth were brushed.","[{'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Ramos-Gomez', 'Affiliation': ""Center to Address Disparities in Children's Oral Health, University of California San Francisco, San Francisco, CA, USA.""}, {'ForeName': 'Justin S', 'Initials': 'JS', 'LastName': 'White', 'Affiliation': ""Center to Address Disparities in Children's Oral Health, University of California San Francisco, San Francisco, CA, USA.""}, {'ForeName': 'Helen E', 'Initials': 'HE', 'LastName': 'Lindau', 'Affiliation': 'Section of Pediatric Dentistry, School of Dentistry, University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Tracy K', 'Initials': 'TK', 'LastName': 'Lin', 'Affiliation': 'Institute for Health & Aging, Department of Social and Behavioral Sciences, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Tracy L', 'Initials': 'TL', 'LastName': 'Finlayson', 'Affiliation': ""Center to Address Disparities in Children's Oral Health, University of California San Francisco, San Francisco, CA, USA.""}, {'ForeName': 'Jenny X', 'Initials': 'JX', 'LastName': 'Liu', 'Affiliation': ""Center to Address Disparities in Children's Oral Health, University of California San Francisco, San Francisco, CA, USA.""}, {'ForeName': 'Stuart A', 'Initials': 'SA', 'LastName': 'Gansky', 'Affiliation': ""Center to Address Disparities in Children's Oral Health, University of California San Francisco, San Francisco, CA, USA.""}]",Journal of public health dentistry,['10.1111/jphd.12406']
1817,33090506,The efficacy of group logotherapy on community-dwelling older adults with depressive symptoms: A mixed methods study.,"PURPOSE


This mixed-methods study evaluated a group logotherapy program's efficacy on Korean older adults with depressive symptoms.
DESIGN AND METHODS


An intervention group (n = 23) participated in eight sessions of group logotherapy; a control group (n = 21) received the usual care. Participants completed the pretest, posttest, and 4-week follow-up questionnaires. Ten participants also had focus group or individual interviews.
FINDINGS


A linear mixed model showed significant differences between groups in terms of changes in purpose in life, depression, self-esteem, and quality of life over time. These quantitative findings were supported and enriched by qualitative data.",2020,"FINDINGS


A linear mixed model showed significant differences between groups in terms of changes in purpose in life, depression, self-esteem, and quality of life over time.","['community-dwelling older adults with depressive symptoms', 'Ten participants also had focus group or individual interviews', 'Korean older adults with depressive symptoms']","['group logotherapy', 'usual care']","['life, depression, self-esteem, and quality of life over time']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C1285542', 'cui_str': 'Has focus'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0204524', 'cui_str': 'Logotherapy'}]","[{'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",23.0,0.0335566,"FINDINGS


A linear mixed model showed significant differences between groups in terms of changes in purpose in life, depression, self-esteem, and quality of life over time.","[{'ForeName': 'Chanhee', 'Initials': 'C', 'LastName': 'Kim', 'Affiliation': 'College of Nursing, Dong-A University, Busan, South Korea.'}, {'ForeName': 'Heeseung', 'Initials': 'H', 'LastName': 'Choi', 'Affiliation': 'College of Nursing and the Research Institute of Nursing Science, Seoul National University, Seoul, South Korea.'}]",Perspectives in psychiatric care,['10.1111/ppc.12635']
1818,33090597,Sleep restriction alters physiological and emotional responses to emotion induction.,"NEW FINDINGS


The aim of the present study was to assess the effects of sleep restriction on self report and autonomic responses to neutral and sad film clips. Ratings of sadness and heart rate deceleration were greater while watching the sad clip, with no effect of sleep restriction; whereas heart rate variability and skin conductance were impacted by sleep restriction and to a lesser extent by film clips. Results suggest that autonomic function was adaptively altered by sleep restriction, so as to maintain a 'normal' response to emotional cues, despite mounting fatigue.
ABSTRACT


Habitual insufficient sleep has long-term health consequences via its impact on the autonomic nervous system (ANS) function and on emotion regulation. To our knowledge, the effects of insufficient sleep on emotion-induced ANS function has not been tested. The present study aimed to address this lacuna. Using an emotion induction procedure, the effects of sleep restriction on physiological responses to validated neutral and sad film clips were assessed in a 2-by-2, pseudo-randomized, cross-over design. Thirty-one participants, ages 20-33, were assessed after sleeping either 5 hrs (sleep restricted, SR) or 8 hrs (well rested, WR) per night, three consecutive nights. Physiological measures included heart rate (HR), heart rate variability (HRV), skin conductance response (SCR), and participants' ratings of affect and fatigue. There was no effect of sleep condition on self-reported negative affect, however watching the sad clip reduced self-reported fatigue in the SR condition. There was greater HR deceleration while watching sad relative to neutral clips, independent of the sleep condition. SR increased HRV measures with no effect of emotion induction. There was an interaction of emotion induction by sleep condition for SCR, with more SCRs to sad relative to neutral clips in the WR condition, and the opposite effect in the SR condition. Combined the results suggest that ANS response to an emotional cue was altered by sleep restriction. The results suggest an adaptive ANS response to mild, but chronic, sleep restriction, resulting in constant HR response and self-reported experience across well-rested and sleep deprived conditions, despite mounting fatigue. This article is protected by copyright. All rights reserved.",2020,"Ratings of sadness and heart rate deceleration were greater while watching the sad clip, with no effect of sleep restriction; whereas heart rate variability and skin conductance were impacted by sleep restriction and to a lesser extent by film clips.","['Thirty-one participants, ages 20-33, were assessed after sleeping either 5 hrs (sleep restricted, SR) or 8 hrs (well rested, WR) per night, three consecutive nights']",['neutral and sad film clips'],"['HR deceleration', 'adaptive ANS response to mild, but chronic, sleep restriction, resulting in constant HR response and self-reported experience across well-rested and sleep deprived conditions, despite mounting fatigue', 'HRV measures', 'heart rate variability and skin conductance', 'autonomic function', ""heart rate (HR), heart rate variability (HRV), skin conductance response (SCR), and participants' ratings of affect and fatigue"", 'Ratings of sadness and heart rate deceleration']","[{'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0240526', 'cui_str': 'Night time'}]","[{'cui': 'C0085159', 'cui_str': 'Seasonal affective disorder'}, {'cui': 'C1704608', 'cui_str': 'Film'}, {'cui': 'C0175722', 'cui_str': 'Clip'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0011100', 'cui_str': 'Deceleration'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C1997754', 'cui_str': 'Heart rate response'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0181909', 'cui_str': 'Mount'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C3536794', 'cui_str': 'Unhappiness'}]",33.0,0.0208879,"Ratings of sadness and heart rate deceleration were greater while watching the sad clip, with no effect of sleep restriction; whereas heart rate variability and skin conductance were impacted by sleep restriction and to a lesser extent by film clips.","[{'ForeName': 'Ilana S', 'Initials': 'IS', 'LastName': 'Hairston', 'Affiliation': 'Psychiatry Department, University of Michigan, Ann Arbor, Israel.'}, {'ForeName': 'Mairav', 'Initials': 'M', 'LastName': 'Cohen-Zion', 'Affiliation': 'School of Behavioral Sciences, Tel Aviv Yafo Academic College, Israel.'}]",Experimental physiology,['10.1113/EP088931']
1819,33090616,Perceptions of provider's epistemic authority in response to variant of uncertain significance-related recommendations.,"Uncertain genetic information such as variants of uncertain significance (VUS) is often encountered by patients in clinical cancer genetic testing. Although healthcare providers facilitate patient's understanding of VUS-associated empirical risk and its medical implications, patients' understanding and perceptions of risk often differ and may be based on subjective evaluations such as their perception of provider's epistemic authority (EA). This study examines the hypothesis that individuals attribute greater EA to genetic counselors (GCs) (compared to gastrointestinal oncologists) and to providers who recommend more active VUS-related recommendations (compared to inactive). In a factorial experiment, 652 adult participants recruited on Amazon Mechanical Turk were block-randomized to read one of 10 different types of VUS-related scenarios in the context of colon cancer (5 recommendation types × 2 provider types). GCs were attributed higher EA than gastrointestinal oncologists (p = <.001). Active recommendations (comprehensive, check back, wrong) were attributed lower EA (M = 3.67, SD = 0.79) compared to the inactive (stand by, disregard) (M = 3.89, SD = 0.67) (p-value = <.001). The wrong recommendation was attributed lowest EA compared to the four correct recommendations (mean difference = -0.34, -0.45, -0.35, and -0.44, respectively; p = .002), which, when dropped from the analysis, showed no difference between the correct active and inactive recommendations (3.78 vs. 3.89, p = .095). The higher EA attributed to GCs is encouraging and possibly explained by increased public awareness of the genetic counseling profession. The lack of difference in EA attributed to various correct, yet incomplete forms of VUS-related recommendation indicates that individuals may be unaware of and thus completely rely on providers for complex medical topics like VUS. Communicating VUS-related uncertainty warrants caution and further research to elucidate best practices and outcomes.",2020,GCs were attributed higher EA than gastrointestinal oncologists (p = <.001).,['652 adult participants recruited on Amazon Mechanical Turk were block-randomized to read one of 10 different types of VUS-related scenarios in the context of colon cancer (5 recommendation types\xa0×\xa02 provider types'],[],['correct active and inactive recommendations'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0325969', 'cui_str': 'Genus Amazona'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0337911', 'cui_str': 'Turks'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205419', 'cui_str': 'Variant'}, {'cui': 'C0087130', 'cui_str': 'Uncertain'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0449255', 'cui_str': 'Context'}, {'cui': 'C0007102', 'cui_str': 'Malignant tumor of colon'}]",[],"[{'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}]",652.0,0.0420725,GCs were attributed higher EA than gastrointestinal oncologists (p = <.001).,"[{'ForeName': 'Sukh', 'Initials': 'S', 'LastName': 'Makhnoon', 'Affiliation': 'Department of Behavioral Science, UT MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Mork', 'Affiliation': 'Department of Clinical Cancer Genetics, UT MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Banu', 'Initials': 'B', 'LastName': 'Arun', 'Affiliation': 'Department of Clinical Cancer Genetics, UT MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Volk', 'Affiliation': 'Department of Health Services Research, UT MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Susan K', 'Initials': 'SK', 'LastName': 'Peterson', 'Affiliation': 'Department of Behavioral Science, UT MD Anderson Cancer Center, Houston, TX, USA.'}]",Journal of genetic counseling,['10.1002/jgc4.1337']
1820,33090733,"Population Pharmacokinetic Analysis of BMS-986166, a Novel Selective Sphingosine-1-Phosphate-1 Receptor Modulator, and Exposure-Response Assessment of Lymphocyte Counts and Heart Rate in Healthy Participants.","Sphingosine-1-phosphate (S1P) binding to the S1P-1 receptor (S1P1R) controls the egress of lymphocytes from lymphoid organs and targets modulation of immune responses in autoimmune diseases. Pharmacologic modulation of S1P receptors has been linked to heart rate reduction. BMS-986166, a prodrug of the active phosphorylated metabolite BMS-986166-P, presents an improved cardiac safety profile in preclinical studies compared to other S1P1R modulators. The pharmacokinetics, safety, and pharmacodynamics of BMS-986166 versus placebo after single (0.75-5.0 mg) and repeated (0.25-1.5 mg/day) oral administration were assessed in healthy participants after a 1-day lead-in placebo period. A population model was developed to jointly describe BMS-986166 and BMS-986166-P pharmacokinetics and predict individual exposures. Inhibitory sigmoid models described the relationships between average daily BMS-986166-P concentrations and nadir of time-matched (day -1) placebo-corrected heart rate on day 1 (nDDHR, where DD represents ∆∆) and nadir of absolute lymphocyte count (nALC). Predicted decreases in nDDHR and nALC were 9 bpm and 20% following placebo, with maximum decreases of 10 bpm in nDDHR due to drug effect, and approximately 80% in nALC due to drug and placebo. A 0.5-mg/day dose regimen achieves the target 65% reduction in nALC associated with a 2-bpm decrease in nDDHR over placebo.",2020,"The pharmacokinetics, safety, and pharmacodynamics of BMS-986166 versus placebo after single (0.75-5.0 mg) and repeated (0.25-1.5 mg/day) oral administration were assessed in healthy participants after a 1-day lead-in placebo period.","['healthy participants after a 1-day lead-in placebo period', 'Healthy Participants']","['placebo', 'BMS-986166 versus placebo', 'Sphingosine-1-phosphate (S1P', 'BMS-986166']","['nDDHR', 'pharmacokinetics, safety, and pharmacodynamics', 'nDDHR and nALC']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0074992', 'cui_str': 'sphingosine 1-phosphate'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}]",,0.12168,"The pharmacokinetics, safety, and pharmacodynamics of BMS-986166 versus placebo after single (0.75-5.0 mg) and repeated (0.25-1.5 mg/day) oral administration were assessed in healthy participants after a 1-day lead-in placebo period.","[{'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Bihorel', 'Affiliation': 'Cognigen Corporation, a SimulationsPlus Company, Buffalo, New York, USA.'}, {'ForeName': 'Shalabh', 'Initials': 'S', 'LastName': 'Singhal', 'Affiliation': 'Bristol Myers Squibb, Princeton, New Jersey, USA.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Shevell', 'Affiliation': 'Bristol Myers Squibb, Princeton, New Jersey, USA.'}, {'ForeName': 'Huadong', 'Initials': 'H', 'LastName': 'Sun', 'Affiliation': 'Previously employed at Bristol Myers Squibb, Princeton, New Jersey, USA.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Xie', 'Affiliation': 'Bristol Myers Squibb, Princeton, New Jersey, USA.'}, {'ForeName': 'Shenita', 'Initials': 'S', 'LastName': 'Basdeo', 'Affiliation': 'Bristol Myers Squibb, Princeton, New Jersey, USA.'}, {'ForeName': 'Ang', 'Initials': 'A', 'LastName': 'Liu', 'Affiliation': 'Bristol Myers Squibb, Princeton, New Jersey, USA.'}, {'ForeName': 'Santanu', 'Initials': 'S', 'LastName': 'Dutta', 'Affiliation': 'Bristol Myers Squibb, Princeton, New Jersey, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Ludwig', 'Affiliation': 'Cognigen Corporation, a SimulationsPlus Company, Buffalo, New York, USA.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Huang', 'Affiliation': 'Cognigen Corporation, a SimulationsPlus Company, Buffalo, New York, USA.'}, {'ForeName': 'Kuan-Ju', 'Initials': 'KJ', 'LastName': 'Lin', 'Affiliation': 'Previously employed at Cognigen Corporation, a SimulationPlus Company, Buffalo, New York, USA.'}, {'ForeName': 'Aberra', 'Initials': 'A', 'LastName': 'Fura', 'Affiliation': 'Bristol Myers Squibb, Princeton, New Jersey, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Throup', 'Affiliation': 'Bristol Myers Squibb, Princeton, New Jersey, USA.'}, {'ForeName': 'Ihab G', 'Initials': 'IG', 'LastName': 'Girgis', 'Affiliation': 'Bristol Myers Squibb, Princeton, New Jersey, USA.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.878']
1821,33090739,Placebo 2.0: the impact of expectations on analgesic treatment outcome.,,2020,,[],['Placebo'],[],[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.16047,,"[{'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Bingel', 'Affiliation': 'Klinik für Neurologie, Universitätsklinikum Essen, Universität Duisburg-Essen, Duisburg, Germany.'}]",Pain,['10.1097/j.pain.0000000000001981']
1822,33085510,"Effect of a Novel Smartphone Application on Breastfeeding Rates Among Low-Income, First-Time Mothers Intending to Exclusively Breastfeed: Secondary Analysis of a Randomized Controlled Trial.","Objective:  To examine the effect of a novel smartphone application (app)-BreastFeeding Friend (BFF)-on breastfeeding rates among low-income first-time mothers planning exclusive breastfeeding.  Methods:  A recent randomized controlled trial (RCT) randomized low-income first-time mothers to BFF or control app. BFF contained breastfeeding education and videos. The control app contained digital breastfeeding handouts. Outcomes included breastfeeding rates until 6 months postpartum and patient-reported best breastfeeding resource. After enrollment, nearly half the participants reported planning formula feeding after breastfeeding initiation, potentially confounding the RCT results. In this secondary analysis, women planning formula feeding were excluded. Outcomes between study groups were compared by intent-to-treat.  Results:  Of the original 170 participants, 41 in BFF and 46 in control group planned exclusively breastfeeding and were included. Exclusive breastfeeding rates were similar from 2 days postpartum (BFF:  n  = 19 [48.7%] versus control app:  n  = 21 [46.7%]; relative risk [RR] = 1.04, 95% confidence interval, CI = 0.67-1.63]) until 6 months postpartum. At 6 weeks postpartum, the majority of BFF users ( n  = 23 [62.2%]) believed an app provided the best breastfeeding support compared with 39% of control app users ( n  = 16; RR = 1.59 [95% CI = 1.01-2.52]). BFF users were 2.5 times more likely to deny having breastfeeding challenges compared with control app users ( n  = 12 [42.9%] versus  n  = 6 [16.7%]; RR = 2.57 [95% CI = 1.10-6.00]).  Conclusion:  BFF reduced self-reported breastfeeding challenges and was perceived as the best breastfeeding resource at home but did not increase breastfeeding rates among low-income first-time mothers desiring to exclusively breastfeed. BFF shows promise but must be further optimized to ultimately impact breastfeeding rates. Trial Identification Number: NCT03167073.",2020,BFF users were 2.5 times more likely to deny having breastfeeding challenges compared with control app users ( n  = 12 [42.9%] versus  n  = 6 [16.7%];,"['170 participants, 41 in BFF and 46 in control group planned exclusively breastfeeding and were included', 'rates among low-income first-time mothers planning exclusive breastfeeding', 'First-Time Mothers Intending to Exclusively Breastfeed']","['novel smartphone application (app)-BreastFeeding Friend (BFF)-on breastfeeding', 'Novel Smartphone Application']","['Exclusive breastfeeding rates', 'breastfeeding rates until 6 months postpartum and patient-reported best breastfeeding resource', 'Breastfeeding Rates', 'breastfeeding rates']","[{'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0242205', 'cui_str': 'Breastfeeding, Exclusive'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0079382', 'cui_str': 'Friend'}]","[{'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0035201', 'cui_str': 'Resources'}]",170.0,0.150521,BFF users were 2.5 times more likely to deny having breastfeeding challenges compared with control app users ( n  = 12 [42.9%] versus  n  = 6 [16.7%];,"[{'ForeName': 'Adam K', 'Initials': 'AK', 'LastName': 'Lewkowitz', 'Affiliation': 'Department of Obstetrics and Gynecology, Warren Alpert Medical School at Brown University, Providence, Rhode Island, USA.'}, {'ForeName': 'Julia D', 'Initials': 'JD', 'LastName': 'López', 'Affiliation': 'Department of Medicine, Washington University in St. Louis, St. Louis, Missouri, USA.'}, {'ForeName': 'Erika F', 'Initials': 'EF', 'LastName': 'Werner', 'Affiliation': 'Department of Obstetrics and Gynecology, Warren Alpert Medical School at Brown University, Providence, Rhode Island, USA.'}, {'ForeName': 'Megan L', 'Initials': 'ML', 'LastName': 'Ranney', 'Affiliation': 'Department of Emergency Medicine, Warren Alpert Medical School at Brown University, Providence, Rhode Island, USA.'}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Macones', 'Affiliation': ""Department of Women's Health, Dell Medical School, University of Texas at Austin, Austin, Texas, USA.""}, {'ForeName': 'Dwight J', 'Initials': 'DJ', 'LastName': 'Rouse', 'Affiliation': 'Department of Obstetrics and Gynecology, Warren Alpert Medical School at Brown University, Providence, Rhode Island, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Savitz', 'Affiliation': 'Department of Epidemiology, Brown School of Public Health, Providence, Rhode Island, USA.'}, {'ForeName': 'Alison G', 'Initials': 'AG', 'LastName': 'Cahill', 'Affiliation': 'Department of Emergency Medicine, Warren Alpert Medical School at Brown University, Providence, Rhode Island, USA.'}]",Breastfeeding medicine : the official journal of the Academy of Breastfeeding Medicine,['10.1089/bfm.2020.0240']
1823,33085532,A Randomized Controlled Trial: The Effect of Own Mother's Breast Milk Odor and Another Mother's Breast Milk Odor on Pain Level of Newborn Infants.,"Objective:  Our research was conducted empirically to determine whether another mother's breast milk could be used to reduce the pain of newborns who were not able to access their own mother's milk for any reason.  Materials and Methods:  The sample group of the research included 90 newborns [smell of own mother's milk (30), smell of another mother's milk (30), and the control group (30)] hospitalized in the unit. A neonatal information form was used as the data collection tool, the Neonatal Pain, Agitation, and Sedation Scale (N-PASS) was used to assess the newborn's pain, and an evaluation form prepared by the researcher was used to record the findings.  Results:  The group which was exposed to their own mothers' milk had a significantly lower N-PASS mean score compared to other groups and the group which was exposed to another mother's milk was observed to have a significantly lower N-PASS mean score compared to the control group ( p  < 0.05). While the median values for the total time spent crying of the ""own mother's milk"" group and the ""another mother's milk"" group were similar; the total time spent crying of the control group had a significantly higher median value.  Conclusion:  Our research determined that, while the most effective method for reducing pain in newborns was the smell of their own mothers' breast milk, for newborns who were not able to access their own mother's breast milk, the smell of breast milk from a different mother could also be used.",2020,The group which was exposed to their own mothers' milk had a significantly lower N-PASS mean score compared to other groups and the group which was exposed to another mother's milk was observed to have a significantly lower N-PASS mean score compared to the control group ( p  < 0.05).,"['on Pain Level of Newborn Infants', ""90 newborns [smell of own mother's milk (30), smell of another mother's milk (30), and the control group (30)] hospitalized in the unit""]","[""Own Mother's Breast Milk Odor and Another Mother's Breast Milk Odor""]","['total time spent crying', 'Neonatal Pain, Agitation, and Sedation Scale (N-PASS', 'N-PASS mean score', 'pain']","[{'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0037361', 'cui_str': 'Sense of smell, function'}, {'cui': 'C0026140', 'cui_str': 'Breast milk'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0439148', 'cui_str': 'Unit'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0028884', 'cui_str': 'With odor'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0010399', 'cui_str': 'Crying'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",90.0,0.0206279,The group which was exposed to their own mothers' milk had a significantly lower N-PASS mean score compared to other groups and the group which was exposed to another mother's milk was observed to have a significantly lower N-PASS mean score compared to the control group ( p  < 0.05).,"[{'ForeName': 'Merve', 'Initials': 'M', 'LastName': 'Cakirli', 'Affiliation': 'Department of Child Health and Disease Nursing, Faculty of Health Sciences, Eskisehir Osmangazi University, Eskisehir, Turkey.'}, {'ForeName': 'Ayfer', 'Initials': 'A', 'LastName': 'Acikgoz', 'Affiliation': 'Department of Child Health and Disease Nursing, Faculty of Health Sciences, Eskisehir Osmangazi University, Eskisehir, Turkey.'}]",Breastfeeding medicine : the official journal of the Academy of Breastfeeding Medicine,['10.1089/bfm.2020.0222']
1824,33085560,Lateral rectus resection versus lateral rectus plication in patients with residual Esotropia.,"This study was aimed to compare the surgical outcomes of lateral rectus plication and resection techniques on patients with residual esotropia. In this randomized clinical trial, a total of 57 patients with residual esotropia (31 females) who were candidates for lateral rectus resection were randomized into plication (n = 27) and resection (n = 30) groups. The inclusion criteria were residual Esotropia after uni- or bilateral medial rectus recession. Subjects with a history of prematurity, lack of central fixation, extraocular muscle palsy, systemic, ocular disorders, history of lateral rectus operation, or follow up less than 3 months were excluded. Ophthalmic examinations were conducted preoperatively and at 1, 3-, and 6-month follow-ups. Surgical success rate was considered postoperative eso- or exotropia ≤10 pd. Based on the study results, there was no statistically significant difference between the two groups regarding the pre- (plication: 27.9 ± 9.8 pd and resection: 26.4 ± 7.6 pd; P = .52) and postoperative mean angle of deviation at far distance in month 3 (plication: 5.1 ± 7.1 pd and resection: 5.4 ± 3.2 pd; P = .82). Postoperative success rate also showed similarity between these two groups at all postoperative follow-ups of months 1, 3, and 6.There was no statistically significant difference between dose responses of these groups in uni- or bilateral operations. In conclusion, lateral rectus plication and resection showed statistically similar results. Each surgical method could be selected according to surgeon's skill and comfort. We recommend plication method for patients with postoperative probability of anterior segment ischemia.",2020,"Postoperative success rate also showed similarity between these two groups at all postoperative follow-ups of months 1, 3, and 6.There was no statistically significant difference between dose responses of these groups in uni- or bilateral operations.","['patients with residual esotropia', 'Subjects with a history of prematurity, lack of central fixation, extraocular muscle palsy, systemic, ocular disorders, history of lateral rectus operation, or follow up less than 3 months were excluded', 'patients with residual Esotropia', 'patients with postoperative probability of anterior segment ischemia', '57 patients with residual esotropia (31 females) who were candidates for lateral rectus resection were randomized into plication (n = 27) and resection (n = 30) groups']","['Lateral rectus resection versus lateral rectus plication', 'lateral rectus plication and resection techniques']","['Surgical success rate', 'Postoperative success rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0339626', 'cui_str': 'Residual esotropia'}, {'cui': 'C4041123', 'cui_str': 'History of prematurity'}, {'cui': 'C0332268', 'cui_str': 'Lacking'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0751401', 'cui_str': 'Ophthalmoparesis'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0582821', 'cui_str': 'Lateral rectus muscle structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C1531582', 'cui_str': 'Anterior segment ischemia'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0395312', 'cui_str': 'Lateral rectus resection'}, {'cui': 'C0185026', 'cui_str': 'Plication'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0395312', 'cui_str': 'Lateral rectus resection'}, {'cui': 'C0582821', 'cui_str': 'Lateral rectus muscle structure'}, {'cui': 'C0185026', 'cui_str': 'Plication'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",57.0,0.0164512,"Postoperative success rate also showed similarity between these two groups at all postoperative follow-ups of months 1, 3, and 6.There was no statistically significant difference between dose responses of these groups in uni- or bilateral operations.","[{'ForeName': 'Zhale', 'Initials': 'Z', 'LastName': 'Rajavi', 'Affiliation': 'Negah Specialty Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences , Tehran.'}, {'ForeName': 'Hamideh', 'Initials': 'H', 'LastName': 'Sabbaghi', 'Affiliation': 'Ophthalmic Epidemiology Research Center, Research Institute for Ophthalmology and Vision Science, Shahid Beheshti University of Medical Sciences , Tehran.'}, {'ForeName': 'Bahareh', 'Initials': 'B', 'LastName': 'Kheiri', 'Affiliation': 'Ophthalmic Research Center, Research Institute for Ophthalmology and Vision Science, Shahid Beheshti University of Medical Sciences , Tehran.'}, {'ForeName': 'Kourosh', 'Initials': 'K', 'LastName': 'Sheibani', 'Affiliation': 'Basir Eye Health Research Center, Basir Eye Clinic , Tehran.'}]",Strabismus,['10.1080/09273972.2020.1832544']
1825,33085578,Evaluation of a Proactive Smoking Cessation Electronic Visit to Extend the Reach of Evidence-Based Cessation Treatment via Primary Care.,"Background:   Best practice guidelines for smoking cessation treatment through primary care advise the 5As model. However, compliance with these guidelines is poor, leaving many smokers untreated. The purpose of this study was to develop and preliminarily evaluate an asynchronous smoking cessation electronic visit (e-visit) that could be delivered proactively through the electronic health record (EHR) to adult smokers treated within primary care. The goal of the e-visit is to automate 5As delivery to ensure that all smokers receive evidence-based cessation treatment. As such, the aims of this study were twofold: (1) to examine acceptability, feasibility, and treatment metrics associated with e-visit utilization and (2) to preliminarily examine efficacy relative to treatment as usual (TAU) within primary care.   Methods:   Participants ( n  = 51) were recruited from primary care practices between November 2018 and October 2019 and randomized 2:1 to receive either the smoking cessation e-visit or TAU. Participants completed assessments of cessation outcomes 1-month and 3-months postenrollment and e-visit analytics data were gathered from the EHR.   Results:   Self-report feedback from e-visit participants indicated satisfaction with the intervention and interest in using e-visits again in the future. Nearly all e-visits resulted in prescription of a U.S. Food and Drug Administration (FDA)-approved smoking cessation medication. In general, smoking cessation outcomes favored the e-visit condition at both 1 (odds ratios [ORs]: 2.10-5.39) and 3 months (ORs: 1.31-4.67).   Conclusions:   These results preliminarily indicate the feasibility, acceptability, and efficacy of this smoking cessation e-visit within primary care. Future studies should focus on larger scale examination of effectiveness and implementation across settings. The clinicaltrials.gov registration number for this trial is NCT04316260.",2020,Self-report feedback from e-visit participants indicated satisfaction with the intervention and interest in using e-visits again in the future.,"['Participants ( n \u2009=\u200951) were recruited from primary care practices between November 2018 and October 2019', 'adult smokers treated within primary care']","['asynchronous smoking cessation electronic visit (e-visit', 'smoking cessation e-visit or TAU']","['feasibility, acceptability, and efficacy']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0439581', 'cui_str': 'Asynchronous'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.0402341,Self-report feedback from e-visit participants indicated satisfaction with the intervention and interest in using e-visits again in the future.,"[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Dahne', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': 'Marty', 'Initials': 'M', 'LastName': 'Player', 'Affiliation': 'Department of Family Medicine, Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Carpenter', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': 'Dee W', 'Initials': 'DW', 'LastName': 'Ford', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': 'Vanessa A', 'Initials': 'VA', 'LastName': 'Diaz', 'Affiliation': 'Department of Family Medicine, Medical University of South Carolina, Charleston, South Carolina, USA.'}]",Telemedicine journal and e-health : the official journal of the American Telemedicine Association,['10.1089/tmj.2020.0167']
1826,33085581,Periodic Kinesthetic Guidance Cannot Expedite Learning Surgical Skills.,"Introduction.  Connecting multiple haptic devices in a master-slave fashion enables us to deliver kinesthetic (haptic) feedback from 1 person to another. This study examined whether inter-user feedback delivered from an expert to a novice would facilitate skill acquisition of the novice in learning laparoscopic surgery and expedite it compared to traditional methods.  Methods.  We recruited fourteen novices and divided them into 1 of 2 training groups with 6 half-hour training sessions. The task was precision cutting adopted from one of the tasks listed in Fundamentals of Laparoscopic Surgery using laparoscopic instruments. In the haptic feedback group (haptic), 8 subjects had the chance to passively feel an expert's performance before they started to practice in each training session. In the self-learning group (control), 6 subjects watched a video before practicing. Each session was video recorded, and task performance was measured by task completion time, number of grasper adjustments, and instrument crossings. Cutting accuracy, defined as the percentage of deviation of the cutting line from the predefined line, was analyzed via computer analysis.  Results.  Results show no significant difference among performance measures between the 2 groups. Participants performed similarly when practicing alone or with periodic haptic feedback.  Discussion.  Further research will be needed for improving our way of integrating between-person haptic feedback with skills training protocol.",2020,This study examined whether inter-user feedback delivered from an expert to a novice would facilitate skill acquisition of the novice in learning laparoscopic surgery and expedite it compared to traditional methods.  ,[],"['Periodic Kinesthetic Guidance', 'practicing alone or with periodic haptic feedback', 'haptic feedback group (haptic']",['performance measures'],[],"[{'cui': 'C0332182', 'cui_str': 'Periodic'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0079809', 'cui_str': 'Measure'}]",14.0,0.0199412,This study examined whether inter-user feedback delivered from an expert to a novice would facilitate skill acquisition of the novice in learning laparoscopic surgery and expedite it compared to traditional methods.  ,"[{'ForeName': 'Fangshi', 'Initials': 'F', 'LastName': 'Lu', 'Affiliation': 'Surgical Simulation Research Lab, Department of Surgery, 3158University of Alberta, Canada.'}, {'ForeName': 'Betty', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Surgical Simulation Research Lab, Department of Surgery, 3158University of Alberta, Canada.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Sanchez', 'Affiliation': 'Surgical Simulation Research Lab, Department of Surgery, 3158University of Alberta, Canada.'}, {'ForeName': 'Ahmad I', 'Initials': 'AI', 'LastName': 'Kathrada', 'Affiliation': 'Surgical Simulation Research Lab, Department of Surgery, 3158University of Alberta, Canada.'}, {'ForeName': 'Mahdi', 'Initials': 'M', 'LastName': 'Tavakoli', 'Affiliation': 'Electrical and Computer Engineering, 3158University of Alberta, Canada.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Zheng', 'Affiliation': 'Surgical Simulation Research Lab, Department of Surgery, 3158University of Alberta, Canada.'}]",Surgical innovation,['10.1177/1553350620967852']
1827,33085647,"Repetitive transcranial magnetic stimulation of the cerebellum improves ataxia and cerebello-fronto plasticity in multiple system atrophy: a randomized, double-blind, sham-controlled and TMS-EEG study.","Cerebellar ataxia is the predominant motor feature of multiple system atrophy cerebellar subtype (MSA-C). Although repetitive transcranial magnetic stimulation (TMS) of the cerebellum is growingly applied in MSA, the mechanism is unknown. We examined dynamic connectivity changes of 20 patients with MSA and 25 healthy controls using TMS combined with electroencephalography. Observations that significantly decreased dynamic cerebello-frontal connectivity in patients have inspired attempts to modulate cerebellar connectivity in order to benefit MSA. We further explore the therapeutic potential of a 10-day treatment of cerebellar intermittent theta burst stimulation (iTBS) in MSA by a randomized, double-blind, sham-controlled trial. The functional reorganization of cerebellar networks was investigated after the end of treatment in active and sham groups. The severity of the symptoms was evaluated using the Scale for Assessment and Rating of Ataxia scores. Patients treated with active stimulation showed an improvement of cerebello-frontal connectivity and balance functions, as revealed by a significant decrease in the ataxia scores (P < 0.01). Importantly, the neural activity of frontal connectivity from 80 to 100 ms after a single TMS was significantly related to the severity of the disease. Our study provides new proof that cerebellar iTBS improves motor imbalance in MSA by acting on cerebello-cortical plasticity.",2020,"Patients treated with active stimulation showed an improvement of cerebello-frontal connectivity and balance functions, as revealed by a significant decrease in the ataxia scores (P < 0.01).","['20 patients with MSA and 25 healthy controls using', 'multiple system atrophy']","['repetitive transcranial magnetic stimulation (TMS', 'Repetitive transcranial magnetic stimulation', 'cerebellar intermittent theta burst stimulation (iTBS', 'TMS combined with electroencephalography']","['ataxia scores', 'functional reorganization of cerebellar networks', 'Scale for Assessment and Rating of Ataxia scores', 'neural activity of frontal connectivity', 'cerebello-frontal connectivity and balance functions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0000294', 'cui_str': 'Mesna'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0393571', 'cui_str': 'Multiple system atrophy'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C0007765', 'cui_str': 'Cerebellar structure'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}]","[{'cui': 'C0004134', 'cui_str': 'Ataxia'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0007765', 'cui_str': 'Cerebellar structure'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",,0.100909,"Patients treated with active stimulation showed an improvement of cerebello-frontal connectivity and balance functions, as revealed by a significant decrease in the ataxia scores (P < 0.01).","[{'ForeName': 'Penghui', 'Initials': 'P', 'LastName': 'Song', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Siran', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Suobin', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Wei', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Lin', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Yuping', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}]",Aging,['10.18632/aging.103946']
1828,33085686,An experimental study of messages communicating potential harms of electronic cigarettes.,"There has been an upsurge of e-cigarette use in the United States in recent years. While e-cigarettes may contain lower levels of toxic chemicals than combusted cigarettes, they still pose serious health hazards, including increased risk for heart and respiratory disease. Despite these risks, public awareness of the health harms of e-cigarettes remains low. Thus, it is important to educate the public about the potential harms of e-cigarettes. This study took themes commonly found in antismoking messages and used them to develop messages about harms of e-cigarettes. A national sample of 2801 current smokers and nonsmokers (aged 18+ years) were randomized to view one of four e-cigarette messages (harmful effect of chemicals, uncertainty about ingredients, distrust of big tobacco, or cost of vaping) or a control message (bottled water ad). Participants' reactions to the messages and behavioral intentions were assessed immediately following the exposure. MANOVA examined effects of the messages on blocks of the outcome variables and univariate analyses estimated adjusted means for each experimental condition for each outcome. The message about harmful chemicals was perceived as the most informative and effective and elicited the highest levels of negative emotions (Ps<0.05). However, on measures of actual effectiveness, the other messages performed equally well. Specifically, messages with different themes (harmful chemicals, uncertainty about ingredients, anti-industry, or financial cost) increased perceived risk of e-cigarettes, support for e-cigarette control, and lowered self-exempting beliefs and intentions to use e-cigarettes (Ps<0.05). Themes commonly used in anti-smoking messages may be effective in educating the public about the potential harm of e-cigarettes. The observed differential effects of the messages suggest the need to use multiple themes in a public education campaign about e-cigarettes.",2020,The message about harmful chemicals was perceived as the most informative and effective and elicited the highest levels of negative emotions (Ps<0.05).,['2801 current smokers and nonsmokers (aged 18+ years'],"['cigarette messages (harmful effect of chemicals, uncertainty about ingredients, distrust of big tobacco, or cost of vaping) or a control message (bottled water ad']","['risk of e-cigarettes, support for e-cigarette control, and lowered self-exempting beliefs and intentions to use e-cigarettes', 'actual effectiveness']","[{'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0337672', 'cui_str': 'Non-smoker'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0220806', 'cui_str': 'Chemical'}, {'cui': 'C0087130', 'cui_str': 'Uncertain'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0052148', 'cui_str': 'APEL protocol'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1572482', 'cui_str': 'Bottled Water'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",2801.0,0.0207487,The message about harmful chemicals was perceived as the most informative and effective and elicited the highest levels of negative emotions (Ps<0.05).,"[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Owusu', 'Affiliation': 'School of Public Health, Georgia State University, Atlanta, Georgia, United States of America.'}, {'ForeName': 'Zachary', 'Initials': 'Z', 'LastName': 'Massey', 'Affiliation': 'School of Public Health, Georgia State University, Atlanta, Georgia, United States of America.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Popova', 'Affiliation': 'School of Public Health, Georgia State University, Atlanta, Georgia, United States of America.'}]",PloS one,['10.1371/journal.pone.0240611']
1829,33085707,Does the size of rewards influence performance in cognitively demanding tasks?,"Classic micro-economic and psychology theories propose different implications of monetary incentives on performance. Empirical studies in sports settings show that athletes generally perform worse when the stakes are higher, while a range of lab studies involving cognitively demanding tasks have led to diverging results, supporting positive, negative and null-effects of higher (vs. lower) stakes. In order to further investigate this issue, we present a pre-registered, randomized, controlled trial of 149 participants solving both anagrams and math addition tasks. We do not find a statistically significant effect of the size of the reward on neither performance, self-reported effort nor intrinsic motivation. We propose that future studies should contrast the potential impact of rewards on different kinds of task, e.g. compare tasks that solely require cognitive effort vs. tasks that require motor skills, as in sports.",2020,"We do not find a statistically significant effect of the size of the reward on neither performance, self-reported effort nor intrinsic motivation.",['149 participants solving both anagrams and math addition tasks'],[],[],"[{'cui': 'C5191071', 'cui_str': '149'}, {'cui': 'C0024934', 'cui_str': 'Mathematics'}, {'cui': 'C0332287', 'cui_str': 'With'}]",[],[],149.0,0.0711794,"We do not find a statistically significant effect of the size of the reward on neither performance, self-reported effort nor intrinsic motivation.","[{'ForeName': 'Joachim A', 'Initials': 'JA', 'LastName': 'Holst-Hansen', 'Affiliation': 'Department of Management, BSS, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Bergenholtz', 'Affiliation': 'Department of Management, BSS, Aarhus University, Aarhus, Denmark.'}]",PloS one,['10.1371/journal.pone.0240291']
1830,33076273,Effect of New Zealand Blackcurrant Extract on Isometric Contraction-Induced Fatigue and Recovery: Potential Muscle-Fiber Specific Effects.,"New Zealand blackcurrant (NZBC) extract has shown performance-enhancing effects during cycling, running and sport climbing. We examined effects of NZBC extract on (1) voluntary and twitch force of the  quadriceps femoris muscles  during repeated isometric contraction-induced fatigue, (2) twitch force during recovery and (3) muscle fiber-specific effects. Familiarized recreationally active males (n = 12, age: 24 ± 5 yrs; height: 180 ± 5 cm; body mass: 89 ± 11 kg) performed sixteen, 5-s voluntary maximal isometric contractions (iMVC) separated by 3-s rest. Twitch force was recorded before, during the 3-s rests and 5-min recovery. Supplementation consisted of 7-days intake of NZBC extract (600 mg∙day -1  containing 210 mg anthocyanin) in a double-blind, randomized, placebo-controlled crossover design with a 14-days washout. NZBC extract allowed for greater force in the first quartile of the iMVCs. Twitch force at baseline was 12% higher with NZBC extract ( p  = 0.05). However, there was no effect of NZBC for twitch force during the 16-iMVCs and recovery. Based on the maximum post-activation potentiation during the placebo 16-iMVCs, four subjects were classified of having a predominant type I or II muscle fiber typology. In type II, NZBC extract provided a trend for increased MVC force (~14%) in the first quartile and for type I in the fourth quartile (~10%). In type I, NZBC extract seemed to have higher twitch forces during the fatiguing exercise protocol and recovery, indicating increased fatigue resistance. New Zealand blackcurrant extract affects force during repeated maximal isometric contractions. Future work on mechanisms by NZBC extract for muscle fiber-specific fatigue-induced force responses is warranted.",2020,Twitch force at baseline was 12% higher with NZBC extract ( p  = 0.05).,"['Familiarized recreationally active males (n = 12, age: 24 ± 5 yrs; height: 180 ± 5 cm; body mass: 89 ± 11 kg) performed sixteen']","['New Zealand blackcurrant (NZBC) extract', 'NZBC', 'placebo', 'NZBC extract', 'New Zealand Blackcurrant Extract', 'NZBC extract (600 mg∙day -1  containing 210 mg anthocyanin', '5-s voluntary maximal isometric contractions (iMVC) separated by 3-s rest']","['twitch forces', 'fatigue resistance', 'Twitch force', 'fatigue, (2) twitch force during recovery and (3) muscle fiber-specific effects', 'MVC force']","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C3715157', 'cui_str': '16'}]","[{'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0453277', 'cui_str': 'Blackcurrants'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0003161', 'cui_str': 'Anthocyanin'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0022205', 'cui_str': 'Muscle isometric contraction'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0035253', 'cui_str': 'Rest'}]","[{'cui': 'C0231530', 'cui_str': 'Muscle twitch'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",4.0,0.172571,Twitch force at baseline was 12% higher with NZBC extract ( p  = 0.05).,"[{'ForeName': 'Mark E T', 'Initials': 'MET', 'LastName': 'Willems', 'Affiliation': 'Institute of Sport, University of Chichester, College Lane, Chichester PO19 6PE, UK.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Bradley', 'Affiliation': 'Institute of Sport, University of Chichester, College Lane, Chichester PO19 6PE, UK.'}, {'ForeName': 'Sam D', 'Initials': 'SD', 'LastName': 'Blacker', 'Affiliation': 'Institute of Sport, University of Chichester, College Lane, Chichester PO19 6PE, UK.'}, {'ForeName': 'Ian C', 'Initials': 'IC', 'LastName': 'Perkins', 'Affiliation': 'Institute of Sport, University of Chichester, College Lane, Chichester PO19 6PE, UK.'}]","Sports (Basel, Switzerland)",['10.3390/sports8100135']
1831,32107929,Cost-Effectiveness Analysis of First-Line FOLFIRI Combined With Cetuximab or Bevacizumab in Patients With RAS Wild-Type Left-Sided Metastatic Colorectal Cancer.,"BACKGROUND


The FIRE-3 phase III clinical trial demonstrated the marked advantage of prolonging the median overall survival of patients with final RAS wild-type (WT) left-sided metastatic colorectal cancer (mCRC) by 38.3 months after treatment with irinotecan, fluorouracil, and leucovorin (FOLFIRI) plus cetuximab and by 28.0 months after treatment with FOLFIRI plus bevacizumab. However, the substantial cost increase and economic impact of using cetuximab imposes a considerable burden on patients and society.
METHODS


A Markov model based on the data collected in the FIRE-3 trial was developed to investigate the cost-effectiveness of treating patients with FOLFIRI plus either cetuximab or bevacizumab from the perspective of the Chinese health-care system. Costs, quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios (ICERs) were calculated over a lifetime horizon. One-way and probabilistic sensitivity analyses were performed by varying potentially modifiable parameters.
RESULTS


In our analysis, the total treatment costs in the bevacizumab and cetuximab groups were $92 549.31 and $94 987.31, respectively, and the QALYs gained were 1.58 and 2.05. In the base-case analysis, compared with bevacizumab, left-sided RAS WT patients receiving cetuximab gained 0.47 more QALYs at an ICER of $5187.23/QALY ($3166.23/LY). The 1-way sensitivity analysis showed that the most influential parameter was the cost of cetuximab. Probabilistic sensitivity analysis indicated that the cost-effective probability of cetuximab group was 92.8% under the willingness-to-pay threshold of $24 081.
CONCLUSIONS


Treatment with FOLFIRI plus cetuximab in Chinese patients with left-sided RAS WT mCRC may improve health outcomes and use financial resources more efficiently than FOLFIRI plus bevacizumab.",2020,"Probabilistic sensitivity analysis indicated that the cost-effective probability of cetuximab group was 92.8% under the willingness-to-pay threshold of $24 081.
","['Chinese patients with left-sided RAS WT mCRC', 'patients with final RAS wild-type (WT) left-sided metastatic colorectal cancer (mCRC) by 38.3 months after treatment with', 'Patients']","['irinotecan, fluorouracil, and leucovorin (FOLFIRI) plus cetuximab', 'Cetuximab or Bevacizumab', 'bevacizumab', 'cetuximab', 'First-Line FOLFIRI', 'FOLFIRI plus cetuximab', 'bevacizumab and cetuximab', 'FOLFIRI plus bevacizumab', 'cetuximab or bevacizumab']","['total treatment costs', 'cost-effective probability', 'Costs, quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios (ICERs']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0445392', 'cui_str': 'Wild'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}]","[{'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0205132', 'cui_str': 'Linear'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0087112', 'cui_str': 'Treatment Costs'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",,0.0255634,"Probabilistic sensitivity analysis indicated that the cost-effective probability of cetuximab group was 92.8% under the willingness-to-pay threshold of $24 081.
","[{'ForeName': 'Jiaqi', 'Initials': 'J', 'LastName': 'Han', 'Affiliation': 'Department of Oncology, Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Desheng', 'Initials': 'D', 'LastName': 'Xiao', 'Affiliation': 'Department of Pathology, Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Chongqing', 'Initials': 'C', 'LastName': 'Tan', 'Affiliation': 'Department of Pharmacy, The Second Xiangya Hospital of Central South University, Changsha, China.'}, {'ForeName': 'Xiaohui', 'Initials': 'X', 'LastName': 'Zeng', 'Affiliation': 'PET-CT Center, The Second Xiangya Hospital of Central South University, Changsha, China.'}, {'ForeName': 'Huabin', 'Initials': 'H', 'LastName': 'Hu', 'Affiliation': 'Department of Medical Oncology, The Sixth Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Zeng', 'Affiliation': 'Department of Oncology, Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Jiang', 'Affiliation': 'Department of Oncology, Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Longjiang', 'Initials': 'L', 'LastName': 'She', 'Affiliation': 'Department of Oncology, Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Linli', 'Initials': 'L', 'LastName': 'Yao', 'Affiliation': 'Department of Oncology, Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Oncology, Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Lanhua', 'Initials': 'L', 'LastName': 'Tang', 'Affiliation': 'Department of Oncology, Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Cancer Research Institute, Hunan Key Laboratory of Nonresolving Inflammation and Cancer, Central South University, Changsha, China.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Department of Oncology, Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Liangfang', 'Initials': 'L', 'LastName': 'Shen', 'Affiliation': 'Department of Oncology, Xiangya Hospital, Central South University, Changsha, China.'}]",Cancer control : journal of the Moffitt Cancer Center,['10.1177/1073274820902271']
1832,32109881,"The Prevalence and 5-Year Incidence Rate of Low Physical Activity in an Urban Population of 10,000 in Southeastern Iran: Relationship With Other Cardiovascular Risk Factors.","BACKGROUND


Because of high prevalence of coronary artery diseases (CADs) in Iran and their relationship with low physical activity (LPA), this study aimed to measure the epidemic size of LPA, its incidence rate, and its relationship with other CAD risk factors in Kerman, Iran.
METHODS


About 10,000 adults were randomly recruited through single-stage cluster sampling. Demographic characteristics, biochemical variables, smoking, opium use, mental status, and physical activities were assessed. The relationship between LPA and 7 other CAD risk factors was measured. Five-year incidence rate of LPA was calculated according to the data from the physically active participants in the first phase of the study (n = 3416) who attended the second phase after 5 years.
RESULTS


The prevalence of low, moderate, and intense physical activity was 47.2%, 34.8%, and 18.0%, respectively. LPA rose from 45.1% to 62.2% after the age of 25 years. Women had higher LPA than men. Participants with LPA had significantly higher chance of cigarette smoking, diabetes, overweight/obesity, hypertension, and opium addiction. Five-year incidence rate of LPA was 5.1 persons/100 person-years among physically active population.
CONCLUSION


Almost half of the studied population suffering from LPA was at risk of CAD. Such risky lifestyle pattern while worsened in the last 5 years makes the emerging of CAD epidemic unavoidable, if appropriate timely interventions not being in place accordingly.",2020,"Participants with LPA had significantly higher chance of cigarette smoking, diabetes, overweight/obesity, hypertension, and opium addiction.","['Urban Population of 10,000 in Southeastern Iran', 'About 10,000 adults were randomly recruited through single-stage cluster sampling', 'Kerman, Iran', 'Participants with']",['LPA'],"['Prevalence and 5-Year Incidence Rate of Low Physical Activity', 'prevalence of low, moderate, and intense physical activity', 'Demographic characteristics, biochemical variables, smoking, opium use, mental status, and physical activities', 'LPA', 'chance of cigarette smoking, diabetes, overweight/obesity, hypertension, and opium addiction']","[{'cui': 'C0041935', 'cui_str': 'Urban Population'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C4704679', 'cui_str': 'Opium Use'}, {'cui': 'C0278060', 'cui_str': 'Mental state'}, {'cui': 'C0239059', 'cui_str': 'Cigarette smoke'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0338777', 'cui_str': 'Opium dependence'}]",10000.0,0.0514732,"Participants with LPA had significantly higher chance of cigarette smoking, diabetes, overweight/obesity, hypertension, and opium addiction.","[{'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Najafipour', 'Affiliation': ''}, {'ForeName': 'Masoomeh', 'Initials': 'M', 'LastName': 'Kahnooji', 'Affiliation': ''}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Baneshi', 'Affiliation': ''}, {'ForeName': 'Mahboobeh', 'Initials': 'M', 'LastName': 'Yeganeh', 'Affiliation': ''}, {'ForeName': 'Milad', 'Initials': 'M', 'LastName': 'Ahmadi Gohari', 'Affiliation': ''}, {'ForeName': 'Mitra', 'Initials': 'M', 'LastName': 'Shadkam Farokhi', 'Affiliation': ''}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Mirzazadeh', 'Affiliation': ''}]",Journal of physical activity & health,['10.1123/jpah.2019-0426']
1833,32148655,Vagus Nerve Stimulation Ameliorates Renal Ischemia-Reperfusion Injury through Inhibiting NF- κ B Activation and iNOS Protein Expression.,"Objective


In renal ischemia/reperfusion injury (RIRI), nuclear factor  κ B (NF- κ B (NF- κ B (NF.
Methods


Eighteen male Sprague-Dawley rats were randomly allocated into the sham group, the I/R group, and the VNS+I/R group, 6 rats per group. An RIRI model was induced by a right nephrectomy and blockade of the left renal pedicle vessels for 45 min. After 6 h of reperfusion, the blood samples and renal samples were collected. The VNS treatment was performed throughout the I/R process in the VNS+I/R group using specific parameters (20 Hz, 0.1 ms in duration, square waves) known to produce a small but reliable bradycardia. Blood was used for evaluation of renal function and inflammatory state. Renal injury was evaluated via TUNEL staining. Renal samples were harvested to evaluate renal oxidative stress, NF- κ B (NF.
Results


The VNS treatment reduces serum creatinine (Cr) and blood urea nitrogen (BUN) levels. Simultaneously, the levels of tumor necrosis factor alpha (TNF- α ), interleukin 6 (IL-6), and interleukin 1-beta (IL-1 β ) were significantly increased in the I/R group, but VNS treatment markedly ameliorated this inflammatory response. Furthermore, the VNS ameliorated oxidant stress and renal injury, indicated by a decrease in 3-nitrotyrosine (3-NT) formation and MDA and MPO levels and an increase in the SOD level compared to that in the I/R group. Finally, the VNS also significantly decreases NF- κ B (NF.
Conclusion


Our findings indicate that NF- κ B activation increased iNOS expression and promoted RIRI and that VNS treatment attenuated RIRI by inhibiting iNOS expression, oxidative stress, and inflammation via NF- κ B inactivation. κ B (NF- κ B (NF.",2020,"Furthermore, the VNS ameliorated oxidant stress and renal injury, indicated by a decrease in 3-nitrotyrosine (3-NT) formation and MDA and MPO levels and an increase in the SOD level compared to that in the I/R group.",['Eighteen male Sprague-Dawley rats'],"['NF- κ B (NF- κ B', 'κ B (NF- κ B (NF']","['inflammatory response', 'renal ischemia/reperfusion injury (RIRI), nuclear factor  κ B', 'blood samples and renal samples', 'iNOS expression, oxidative stress, and inflammation via NF- κ B inactivation', 'iNOS expression', 'levels of tumor necrosis factor alpha (TNF- α ), interleukin 6 (IL-6), and interleukin 1-beta (IL-1 β ', 'renal oxidative stress, NF- κ B (NF.\nResults', 'SOD level', 'serum creatinine (Cr) and blood urea nitrogen (BUN) levels', '3-nitrotyrosine (3-NT) formation and MDA and MPO levels', 'oxidant stress and renal injury']","[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0034715', 'cui_str': 'Sprague-Dawley rat'}]",[],"[{'cui': 'C0920646', 'cui_str': 'Ischemia of kidney'}, {'cui': 'C0035126', 'cui_str': 'Ischemia-reperfusion injury'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0669372', 'cui_str': 'NOS2A protein, human'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0021753', 'cui_str': 'interleukin-1, beta'}, {'cui': 'C0021755', 'cui_str': 'Interleukin-1'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0005845', 'cui_str': 'Blood urea nitrogen measurement'}, {'cui': 'C0047645', 'cui_str': '3-nitrotyrosine'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0000379', 'cui_str': 'Methylenedioxyamphetamine'}, {'cui': 'C0027021', 'cui_str': 'Peroxidase'}, {'cui': 'C0085403', 'cui_str': 'Oxidizing Agents'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0160420', 'cui_str': 'Injury of kidney'}]",18.0,0.0210879,"Furthermore, the VNS ameliorated oxidant stress and renal injury, indicated by a decrease in 3-nitrotyrosine (3-NT) formation and MDA and MPO levels and an increase in the SOD level compared to that in the I/R group.","[{'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, Renmin Hospital of Wuhan University, Wuhan, 430060 Hubei, China.'}, {'ForeName': 'Jielin', 'Initials': 'J', 'LastName': 'Deng', 'Affiliation': 'Department of Cardiology, Renmin Hospital of Wuhan University, Wuhan, 430060 Hubei, China.'}, {'ForeName': 'Huanzhu', 'Initials': 'H', 'LastName': 'Lai', 'Affiliation': 'Department of Cardiology, First Hospital of Jilin University, Changchun, 130021 Jilin, China.'}, {'ForeName': 'Yanqiu', 'Initials': 'Y', 'LastName': 'Lai', 'Affiliation': 'Department of Cardiology, Renmin Hospital of Wuhan University, Wuhan, 430060 Hubei, China.'}, {'ForeName': 'Guannan', 'Initials': 'G', 'LastName': 'Meng', 'Affiliation': 'Department of Cardiology, Renmin Hospital of Wuhan University, Wuhan, 430060 Hubei, China.'}, {'ForeName': 'Zhenya', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, Renmin Hospital of Wuhan University, Wuhan, 430060 Hubei, China.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'Department of Cardiology, Renmin Hospital of Wuhan University, Wuhan, 430060 Hubei, China.'}, {'ForeName': 'Hu', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiology, Renmin Hospital of Wuhan University, Wuhan, 430060 Hubei, China.'}, {'ForeName': 'Zhiyao', 'Initials': 'Z', 'LastName': 'Yu', 'Affiliation': 'Department of Cardiology, Renmin Hospital of Wuhan University, Wuhan, 430060 Hubei, China.'}, {'ForeName': 'Shuyan', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, First Hospital of Jilin University, Changchun, 130021 Jilin, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Jiang', 'Affiliation': 'Department of Cardiology, Renmin Hospital of Wuhan University, Wuhan, 430060 Hubei, China.'}]",Oxidative medicine and cellular longevity,['10.1155/2020/7106525']
1834,30928658,Dupilumab improves patient-reported outcomes in patients with chronic rhinosinusitis with nasal polyps and comorbid asthma.,,2019,,['patients with chronic rhinosinusitis with nasal polyps and comorbid asthma'],['Dupilumab'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0027430', 'cui_str': 'Polyp of nasal cavity'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}]","[{'cui': 'C3660996', 'cui_str': 'dupilumab'}]",[],,0.02062,,"[{'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Bachert', 'Affiliation': 'Upper Airway Research Laboratory, Department of Otorhinolaryngology, Ghent University Hospital, Ghent, Belgium; CLINTEC, Karolinska Institute, Stockholm, Sweden. Electronic address: Claus.Bachert@UGent.be.'}, {'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'Hellings', 'Affiliation': 'Laboratory of Experimental Immunology, Department of Otorhinolaryngology-Head and Neck Surgery, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Joaquim', 'Initials': 'J', 'LastName': 'Mullol', 'Affiliation': 'IDIBAPS, Hospital Clínic Barcelona, University of Barcelona, CIBERES, Barcelona, Catalonia, Spain.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Naclerio', 'Affiliation': 'Johns Hopkins Hospital, Baltimore, Md.'}, {'ForeName': 'Jingdong', 'Initials': 'J', 'LastName': 'Chao', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY.'}, {'ForeName': 'Nikhil', 'Initials': 'N', 'LastName': 'Amin', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Grabher', 'Affiliation': 'Sanofi, Bridgewater, NJ.'}, {'ForeName': 'Brian N', 'Initials': 'BN', 'LastName': 'Swanson', 'Affiliation': 'Sanofi, Bridgewater, NJ.'}, {'ForeName': 'Jennifer D', 'Initials': 'JD', 'LastName': 'Hamilton', 'Affiliation': 'Sanofi, Bridgewater, NJ.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Guillonneau', 'Affiliation': 'Sanofi, Chilly-Mazarin, France.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Taniou', 'Affiliation': 'Altran Technologies, Vélizy-Villacoublay, France.'}, {'ForeName': 'Donghui', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'Sanofi, Bridgewater, NJ.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Pirozzi', 'Affiliation': 'Sanofi, Bridgewater, NJ.'}, {'ForeName': 'Neil M H', 'Initials': 'NMH', 'LastName': 'Graham', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY.'}, {'ForeName': 'Heribert', 'Initials': 'H', 'LastName': 'Staudinger', 'Affiliation': 'Sanofi, Bridgewater, NJ.'}, {'ForeName': 'Leda P', 'Initials': 'LP', 'LastName': 'Mannent', 'Affiliation': 'Sanofi, Chilly-Mazarin, France.'}, {'ForeName': 'Asif', 'Initials': 'A', 'LastName': 'Khan', 'Affiliation': 'Sanofi, Chilly-Mazarin, France.'}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2019.03.023']
1835,31812457,The effect of retroactive memory interference on the P300-based Complex Trial Protocol (CTP).,"In a P300-based concealed information test (CIT), an increased response to a crime-related ""probe"" item of interest suggests concealed knowledge. Because the CIT's detection ability is based on knowledgeable parties recognizing the key item, weakening the crime memory might decrease probe identifiability and reduce diagnostic power. Research on retroactive memory interference (RI) has shown that acquiring new information after encoding a memory can degrade the original memory, which suggests that RI might pose a threat to CITs. To test this, Gronau et al. (2015) had participants complete a mock-crime, followed by either a control task or a RI manipulation task, intended to impair the crime memory. Both the simple guilty control and RI groups were subdivided into three time delay conditions: 1/3 of participants immediately completed the task and CIT, another 1/3 completed the task and returned a week later for the CIT, and the remaining participants completed both the task and CIT a week later. Results showed that RI reduced memory of crime details and skin conductance responses, while respiration line length was unaffected. Here, we extend Gronau et al. (2015), using the Complex Trial Protocol (CTP) version of the P300-based CIT, to investigate the influence of RI on recognition. The CIT effect was obvious in all six group × time delay subconditions, as evidenced by their significantly larger probe vs. irrelevant amplitudes, high percentage of bootstrapped iterations where probe > irrelevants, bootstrapped mean amplitude differences, and satisfactory hit rates. However, these indices of the CIT effect did not differ based on group or time delay, as was the case for target response error rates and P300 latencies. The only outcome of interest to vary by group or time delay was behavioral response times: both probe and combined irrelevant responses were delayed in the control (simple guilty) group. Thus, the evidence suggests that the RI manipulation used here does not threaten the P300-based CTP's accuracy. Results are considered as they compare to previous work, and limitations and possible explanations for our results are discussed.",2020,"The CIT effect was obvious in all six group × time delay subconditions, as evidenced by their significantly larger probe vs. irrelevant amplitudes, high percentage of bootstrapped iterations where probe > irrelevants,",[],['control task or a RI manipulation task'],"['behavioral response times: both probe and combined irrelevant responses', 'RI reduced memory of crime details and skin conductance responses, while respiration line length', 'CIT effect']",[],"[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0010325', 'cui_str': 'Crime'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0443189', 'cui_str': 'Concealed'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",,0.017092,"The CIT effect was obvious in all six group × time delay subconditions, as evidenced by their significantly larger probe vs. irrelevant amplitudes, high percentage of bootstrapped iterations where probe > irrelevants,","[{'ForeName': 'Anne C', 'Initials': 'AC', 'LastName': 'Ward', 'Affiliation': 'Department of Psychology, Northwestern University, Evanston, IL, USA. Electronic address: anneward2013@u.northwstern.edu.'}, {'ForeName': 'J Peter', 'Initials': 'JP', 'LastName': 'Rosenfeld', 'Affiliation': 'Department of Psychology, Northwestern University, Evanston, IL, USA.'}, {'ForeName': 'Evan J', 'Initials': 'EJ', 'LastName': 'Sitar', 'Affiliation': 'Department of Psychology, Northwestern University, Evanston, IL, USA.'}, {'ForeName': 'Joshua D', 'Initials': 'JD', 'LastName': 'Wasserman', 'Affiliation': 'Department of Psychology, Northwestern University, Evanston, IL, USA.'}]",International journal of psychophysiology : official journal of the International Organization of Psychophysiology,['10.1016/j.ijpsycho.2019.10.016']
1836,31833543,Antibiotic Cocktail for Pediatric Acute Severe Colitis and the Microbiome: The PRASCO Randomized Controlled Trial.,"BACKGROUND


Alterations in the microbiome have been postulated to drive inflammation in IBD. In this pilot randomized controlled trial, we evaluated the effectiveness of quadruple antibiotic cocktail in addition to intravenous-corticosteroids (IVCSs) in acute severe colitis (ASC).
METHODS


Hospitalized children with ASC (pediatric ulcerative colitis activity index [PUCAI] ≥65) were randomized into 2 arms: the first received antibiotics in addition to IVCS (amoxicillin, vancomycin, metronidazole, doxycycline/ciprofloxacin [IVCS+AB]), whereas the other received only IVCS for 14 days. The primary outcome was disease activity (PUCAI) at day 5. Microbiome was analyzed using 16S rRNA gene and metagenome.
RESULTS


Twenty-eight children were included: 16 in the AB + IVCS arm and 12 in the IVCS arm (mean age 13.9 ± 4.1 years and 23 [82%] with extensive colitis). The mean day-5 PUCAI was 25 ± 16.7 vs 40.4 ± 20.4, respectively (P = 0.037). Only 3 and 2 children, respectively, required colectomy during 1-year follow-up (P = 0.89). Microbiome data at time of admission were analyzed for 25 children, of whom 17 (68%) had a predominant bacterial species (>33% abundance); response was not associated with the specific species, whereas decreased microbiome diversity at admission was associated with day-5 response in the IVCS arm.
CONCLUSION


Patients with ASC have alterations in the microbiome characterized by loss of diversity and presence of predominant bacterial species. Quadruple therapy in addition to IVCS improved disease activity on day 5, but larger studies are needed to determine whether this is associated with improved long-term outcomes (clinicaltrials.gov NCT02033408).",2020,"Only 3 and 2 children, respectively, required colectomy during 1-year follow-up (P = 0.89).","['Pediatric Acute Severe Colitis and the Microbiome', 'acute severe colitis (ASC', 'Hospitalized children with ASC (pediatric ulcerative colitis activity index [PUCAI] ≥65', 'mean age 13.9\u2005±\u20054.1 years and 23 [82%] with extensive colitis', 'Twenty-eight children were included: 16 in the AB\u2005+\u2005IVCS arm and 12 in the IVCS arm']","['quadruple antibiotic cocktail', 'Antibiotic Cocktail', 'IVCS (amoxicillin, vancomycin, metronidazole, doxycycline/ciprofloxacin [IVCS+AB', 'intravenous-corticosteroids (IVCSs']","['mean day-5 PUCAI', 'Microbiome data at time of admission', 'disease activity (PUCAI', 'disease activity']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009319', 'cui_str': 'Colitis'}, {'cui': 'C1956108', 'cui_str': 'Microbiome'}, {'cui': 'C0008098', 'cui_str': 'Children, Hospitalized'}, {'cui': 'C2931173', 'cui_str': 'Pediatric ulcerative colitis'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517562', 'cui_str': '13.9'}, {'cui': 'C4517756', 'cui_str': '4.1'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205231', 'cui_str': 'Extensive'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0205175', 'cui_str': 'Quadruple'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0678420', 'cui_str': 'Cocktail'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0042313', 'cui_str': 'Vancomycin'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C0013090', 'cui_str': 'Doxycycline'}, {'cui': 'C0008809', 'cui_str': 'Ciprofloxacin'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1956108', 'cui_str': 'Microbiome'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]",28.0,0.157772,"Only 3 and 2 children, respectively, required colectomy during 1-year follow-up (P = 0.89).","[{'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Turner', 'Affiliation': 'Shaare Zedek Medical Center, The Hebrew University of Jerusalem, Israel.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Bishai', 'Affiliation': 'The Broad Institute of MIT and Harvard, Cambridge, MA, USA.'}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Reshef', 'Affiliation': 'School of Molecular Cell Biology and Biotechnology, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Guila', 'Initials': 'G', 'LastName': 'Abitbol', 'Affiliation': 'Shaare Zedek Medical Center, The Hebrew University of Jerusalem, Israel.'}, {'ForeName': 'Gili', 'Initials': 'G', 'LastName': 'Focht', 'Affiliation': 'Shaare Zedek Medical Center, The Hebrew University of Jerusalem, Israel.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Marcus', 'Affiliation': 'Shaare Zedek Medical Center, The Hebrew University of Jerusalem, Israel.'}, {'ForeName': 'Oren', 'Initials': 'O', 'LastName': 'Ledder', 'Affiliation': 'Shaare Zedek Medical Center, The Hebrew University of Jerusalem, Israel.'}, {'ForeName': 'Raffi', 'Initials': 'R', 'LastName': 'Lev-Tzion', 'Affiliation': 'Shaare Zedek Medical Center, The Hebrew University of Jerusalem, Israel.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Orlanski-Meyer', 'Affiliation': 'Shaare Zedek Medical Center, The Hebrew University of Jerusalem, Israel.'}, {'ForeName': 'Baruch', 'Initials': 'B', 'LastName': 'Yerushalmi', 'Affiliation': 'Pediatric Gastroenterology Unit, Soroka University Medical Center and Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Aloi', 'Affiliation': 'Sapienza University of Rome, Italy.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Griffiths', 'Affiliation': 'The Hospital for Sick Children (SickKids), Toronto, Canada.'}, {'ForeName': 'Lindsey', 'Initials': 'L', 'LastName': 'Albenberg', 'Affiliation': ""The Children's Hospital of Philadelphia (CHOP), Philadelphia, PA, USA.""}, {'ForeName': 'Kaija-Leena', 'Initials': 'KL', 'LastName': 'Kolho', 'Affiliation': 'Hospital for Children and Adolescents, Children´s Hospital, Helsinki University, Helsinki, Finland.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Assa', 'Affiliation': ""Schneider Children's Medical Center, Petah Tikvah, Israel.""}, {'ForeName': 'Shlomi', 'Initials': 'S', 'LastName': 'Cohen', 'Affiliation': ""Dana-Dwek Children's Hospital, Tel Aviv Sourasky Medical Center, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.""}, {'ForeName': 'Uri', 'Initials': 'U', 'LastName': 'Gophna', 'Affiliation': 'School of Molecular Cell Biology and Biotechnology, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Hera', 'Initials': 'H', 'LastName': 'Vlamakis', 'Affiliation': 'The Broad Institute of MIT and Harvard, Cambridge, MA, USA.'}, {'ForeName': 'Eberhard', 'Initials': 'E', 'LastName': 'Lurz', 'Affiliation': 'Wolfson Medical Center, Holon, Israel.'}, {'ForeName': 'Arie', 'Initials': 'A', 'LastName': 'Levine', 'Affiliation': ""Dr. von Hauner Children's Hospital, Ludwig Maximilians-University, Munich, Germany.""}]",Inflammatory bowel diseases,['10.1093/ibd/izz298']
1837,33084082,Drinking Motives as Moderators of In-the-Moment Drinking Risks in Response to Trauma-Related Distress.,"BACKGROUND


Trauma exposure and PTSD symptomatology are linked to increased risk for problematic drinking, yet the factors that increase such risk remain largely unknown. Theoretical models suggest that affectively-oriented drinking motives may be central to trauma-related drinking. Specifically, individual-level motivations to drink to regulate affect may be important for moderating drinking urges that occur acutely in response to trauma cues. Further, elevated distress associated with PTSD symptomatology may increase any affectively-motivated, momentary drinking risks. However, research has yet to examine these dynamic affective processes. In a large experimental sample, the current study tested whether affective (i.e., coping and enhancement) drinking motives and PTSD symptomatology moderated individuals' drinking urge in response to a trauma cue in a laboratory cue reactivity paradigm.
METHODS


College drinkers (n = 611, 53% female) were recruited and selected across levels of trauma exposure and PTSD symptomatology by a structured clinical interview. Participants were randomized to a personalized trauma or neutral cue, reporting on their urge to drink alcohol before and after cue exposure. Drinking motives were assessed at the end of the experimental session.
RESULTS


Trauma cue associations with drinking urge were moderated by coping, but not enhancement, motives. Specifically, stronger coping motives were associated with increases in urge to drink alcohol following exposure to a trauma but not neutral cue. PTSD classification did not significantly moderate these associations.
CONCLUSIONS


Coping motives may increase drinking urge immediately following exposure to trauma cues and may differentiate individuals most at risk for problematic drinking during trauma-associated distress. Findings support momentary negative affect processes driving dynamic, immediate trauma-related drinking risks.",2020,"Specifically, stronger coping motives were associated with increases in urge to drink alcohol following exposure to a trauma but not neutral cue.","['College drinkers (n = 611, 53% female) were recruited and selected across levels of trauma exposure and PTSD symptomatology by a structured clinical interview']","['personalized trauma or neutral cue, reporting on their urge to drink alcohol before and after cue exposure']",['Drinking motives'],"[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0199182', 'cui_str': 'History taking'}]","[{'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]","[{'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}]",,0.0142726,"Specifically, stronger coping motives were associated with increases in urge to drink alcohol following exposure to a trauma but not neutral cue.","[{'ForeName': 'Michelle J', 'Initials': 'MJ', 'LastName': 'Zaso', 'Affiliation': 'Clinical and Research Institute on Addictions, University at Buffalo, The State University of New York, Buffalo, New York, USA.'}, {'ForeName': 'Jennifer P', 'Initials': 'JP', 'LastName': 'Read', 'Affiliation': 'Department of Psychology, University at Buffalo, The State University of New York, Buffalo, New York, USA.'}]","Alcoholism, clinical and experimental research",['10.1111/acer.14487']
1838,33084081,"Low-dose ketamine affects blood pressure, but not muscle sympathetic nerve activity, during progressive central hypovolemia without altering tolerance.","KEY POINTS


Haemorrhage is the leading cause of battlefield and civilian trauma deaths. Given that a haemorrhagic injury on the battlefield is almost always associated with pain, it is paramount that the administered pain medication does not disrupt the physiological mechanisms that are beneficial in defending against the haemorrhagic insult. Current guidelines from the US Army's Committee on Tactical Combat Casualty Care (CoTCCC) for the selection of pain medications administered to a haemorrhaging soldier are based upon limited scientific evidence, with the clear majority of supporting studies being conducted on anaesthetized animals. Specifically, the influence of low-dose ketamine, one of three analgesics employed in the pre-hospital setting by the US Army, on haemorrhagic tolerance in humans is unknown. For the first time in conscious males and females, the findings of the present study demonstrate that the administration of an analgesic dose of ketamine does not compromise tolerance to a simulated haemorrhagic insult. Increases in muscle sympathetic nerve activity during progressive lower-body negative pressure were not different between trials. Despite the lack of differences for muscle sympathetic nerve activity responses, mean blood pressure and heart rate were higher during moderate hypovolemia after ketamine vs. placebo administration.
ABSTRACT


Haemorrhage is the leading cause of battlefield and civilian trauma deaths. For a haemorrhaging soldier, there are several pain medications (e.g. ketamine) recommended for use in the prehospital, field setting. However, the data to support these recommendations are primarily limited to studies in animals. Therefore, it is unknown whether ketamine adversely affects physiological mechanisms responsible for maintenance of arterial blood pressure (BP) during haemorrhage in humans. In humans, ketamine has been demonstrated to raise resting BP, although it has not been studied with the concomitant central hypovolemia that occurs during haemorrhage. Thus, the present study aimed to test the hypothesis that ketamine does not impair haemorrhagic tolerance in humans. Thirty volunteers (15 females) participated in this double-blinded, randomized, placebo-controlled trial. A pre-syncopal limited progressive lower-body negative pressure (LBNP; a validated model for simulating haemorrhage) test was conducted following the administration of ketamine (20 mg) or placebo (saline). Tolerance was quantified as a cumulative stress index and compared between trials using a paired, two-tailed t test. We compared muscle sympathetic nerve activity (MSNA; microneurography), beat-to-beat BP (photoplethysmography) and heart rate (electrocardiogram) responses during the LBNP test using a mixed effects model (time [LBNP stage] × drug). Tolerance to the LBNP test was not different between trials (Ketamine: 635 ± 391 vs. Placebo: 652 ± 360 mmHg‧min, p = 0.77). Increases in MSNA burst frequency (time: P < 0.01, trial: p = 0.27, interaction: p = 0.39) during LBNP stages were no different between trials. Despite the lack of differences for MSNA responses, mean BP (time: P < 0.01, trial: P < 0.01, interaction: p = 0.01) and heart rate (time: P < 0.01, trial: P < 0.01, interaction: P < 0.01) were higher during moderate hypovolemia after ketamine vs. placebo administration (P < 0.05 for all, post hoc), but not at the end of LBNP. These data, which are the first to be obtained in conscious humans, demonstrate that the administration of low-dose ketamine does not impair tolerance to simulated haemorrhage or mechanisms responsible for maintenance of BP.",2020,"Increases in MSNA burst frequency (time: P < 0.01, trial: p = 0.27, interaction: p = 0.39) during LBNP stages were no different between trials.","['humans', 'Thirty volunteers (15 females', 'conscious males and females']","['placebo (saline', 'Low-dose ketamine', 'ketamine', 'placebo', 'muscle sympathetic nerve activity (MSNA; microneurography', 'Placebo', 'ketamine vs. placebo']","['Tolerance', 'MSNA responses, mean BP', 'MSNA burst frequency', 'blood pressure', 'muscle sympathetic nerve activity responses, mean blood pressure and heart rate', 'beat-to-beat BP (photoplethysmography) and heart rate (electrocardiogram) responses', 'moderate hypovolemia', 'heart rate', 'muscle sympathetic nerve activity', 'arterial blood pressure (BP', 'haemorrhagic tolerance', 'cumulative stress index']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0234421', 'cui_str': 'Consciousness'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0459521', 'cui_str': 'Sympathetic nerve structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]","[{'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0459521', 'cui_str': 'Sympathetic nerve structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C1997754', 'cui_str': 'Heart rate response'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0546884', 'cui_str': 'Hypovolemia'}, {'cui': 'C1272641', 'cui_str': 'Systemic arterial pressure'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",30.0,0.244271,"Increases in MSNA burst frequency (time: P < 0.01, trial: p = 0.27, interaction: p = 0.39) during LBNP stages were no different between trials.","[{'ForeName': 'Mu', 'Initials': 'M', 'LastName': 'Huang', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas, Dallas, TX, USA.'}, {'ForeName': 'Joseph C', 'Initials': 'JC', 'LastName': 'Watso', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas, Dallas, TX, USA.'}, {'ForeName': 'Gilbert', 'Initials': 'G', 'LastName': 'Moralez', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas, Dallas, TX, USA.'}, {'ForeName': 'Matthew N', 'Initials': 'MN', 'LastName': 'Cramer', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas, Dallas, TX, USA.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Hendrix', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas, Dallas, TX, USA.'}, {'ForeName': 'Jeung-Ki', 'Initials': 'JK', 'LastName': 'Yoo', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas, Dallas, TX, USA.'}, {'ForeName': 'Mark B', 'Initials': 'MB', 'LastName': 'Badrov', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas, Dallas, TX, USA.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Fu', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas, Dallas, TX, USA.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Hinojosa-Laborde', 'Affiliation': 'US Army Institute of Surgical Research, JBSA Fort Sam Houston, TX, USA.'}, {'ForeName': 'Craig G', 'Initials': 'CG', 'LastName': 'Crandall', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas, Dallas, TX, USA.'}]",The Journal of physiology,['10.1113/JP280491']
1839,33084088,Cerebral effects of GLP-1 receptor blockade before and after Roux-en-Y Gastric Bypass in obese women: a proof-of-concept resting-state fMRI study.,"AIMS


Roux-en-Y Gastric Bypass (RYGB) is an intervention to achieve long term weight loss in obesity. RYGB provokes increases in glucagon-like peptide-1 (GLP-1) production and sensitivity, which have been implicated in RYGB-related changes in brain responses to food cues and food intake. The effects of these RYGB-related changes in GLP-1 on cerebral resting-state functioning are unknown.
MATERIALS AND METHODS


In 9 middle-aged obese females in the fasted state, we studied the effects of RYGB and GLP-1 on 5 a priori selected networks implicated in food- and reward-related processes as well as environment monitoring (default mode, right frontoparietal, basal ganglia, insula/anterior cingulate, and anterior cingulate/orbitofrontal networks).
RESULTS


Before surgery, GLP-1 receptor blockade (using exendin9-39), was associated with increased right caudate nucleus (basal ganglia network) and decreased right middle frontal (right frontoparietal network) connectivity compared to placebo. RYGB resulted in decreased right orbitofrontal (insula/anterior cingulate network) connectivity. In the default mode network, after surgery, GLP-1 receptor blockade had a larger effect on connectivity in this region than GLP-1 receptor blockade before RYGB (all P FWE  <0.05). Results remained similar after correction for changes in body weight. Default mode and right frontoparietal network connectivity changes were related to changes in BMI and food scores after RYGB.
CONCLUSIONS


These findings suggest GLP-1 involvement in resting-state networks related to food and reward processes and monitoring of the internal and external environment, pointing to a potential role for GLP-1 induced changes in resting-state connectivity in RYGB-mediated weight loss and appetite control. This article is protected by copyright. All rights reserved.",2020,"Default mode and right frontoparietal network connectivity changes were related to changes in BMI and food scores after RYGB.
","['obese women', '9 middle-aged obese females']","['GLP-1 receptor blockade', 'Roux-en-Y Gastric Bypass', 'Roux-en-Y Gastric Bypass (RYGB', 'RYGB', 'placebo']","['BMI and food scores', 'right caudate nucleus (basal ganglia network) and decreased right middle frontal (right frontoparietal network) connectivity', 'body weight', 'right orbitofrontal (insula/anterior cingulate network) connectivity', 'glucagon-like peptide-1']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}]","[{'cui': 'C0378073', 'cui_str': 'GLP-1R Receptor'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0007461', 'cui_str': 'Caudate nucleus structure'}, {'cui': 'C0004781', 'cui_str': 'Basal ganglion structure'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0021640', 'cui_str': 'Insular structure'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate Gyrus'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}]",,0.0226995,"Default mode and right frontoparietal network connectivity changes were related to changes in BMI and food scores after RYGB.
","[{'ForeName': 'Eelco', 'Initials': 'E', 'LastName': 'van Duinkerken', 'Affiliation': 'Department of Medical Psychology, Amsterdam University Medical Centers, Vrije Universiteit, Amsterdam, The Netherlands.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Bernardes', 'Affiliation': 'Departament of Psychology, Pontifícia Universidade Católica do Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Liselotte', 'Initials': 'L', 'LastName': 'van Bloemendaal', 'Affiliation': 'Amsterdam Diabetes Center / Department of Internal Medicine, Amsterdam University Medical Centers, Vrije Universiteit, Amsterdam, The Netherlands.'}, {'ForeName': 'Dick J', 'Initials': 'DJ', 'LastName': 'Veltman', 'Affiliation': 'Department of Psychiatry, Amsterdam University Medical Centers, Vrije Universiteit, Amsterdam, The Netherlands.'}, {'ForeName': 'Frederik', 'Initials': 'F', 'LastName': 'Barkhof', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Amsterdam University Medical Centers, Vrije Universiteit, Amsterdam, The Netherlands.'}, {'ForeName': 'Daniel C', 'Initials': 'DC', 'LastName': 'Mograbi', 'Affiliation': 'Departament of Psychology, Pontifícia Universidade Católica do Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Victor Ea', 'Initials': 'VE', 'LastName': 'Gerdes', 'Affiliation': 'Department of Internal Medicine, Spaarne Gasthuis, Hoofddorp, The Netherlands.'}, {'ForeName': 'Carolyn F', 'Initials': 'CF', 'LastName': 'Deacon', 'Affiliation': 'Novo Nordisk Foundation Center for Basic Metabolic Research and Department of Biomedical Sciences, Panum Institute, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jens J', 'Initials': 'JJ', 'LastName': 'Holst', 'Affiliation': 'Novo Nordisk Foundation Center for Basic Metabolic Research and Department of Biomedical Sciences, Panum Institute, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Madeleine L', 'Initials': 'ML', 'LastName': 'Drent', 'Affiliation': 'Amsterdam Diabetes Center / Department of Internal Medicine, Amsterdam University Medical Centers, Vrije Universiteit, Amsterdam, The Netherlands.'}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Diamant', 'Affiliation': 'Amsterdam Diabetes Center / Department of Internal Medicine, Amsterdam University Medical Centers, Vrije Universiteit, Amsterdam, The Netherlands.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Ten Kulve', 'Affiliation': 'Amsterdam Diabetes Center / Department of Internal Medicine, Amsterdam University Medical Centers, Vrije Universiteit, Amsterdam, The Netherlands.'}, {'ForeName': 'Richard G', 'Initials': 'RG', 'LastName': 'IJzerman', 'Affiliation': 'Amsterdam Diabetes Center / Department of Internal Medicine, Amsterdam University Medical Centers, Vrije Universiteit, Amsterdam, The Netherlands.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14233']
1840,33084149,"Empagliflozin treatment effects across categories of baseline HbA1c, body weight and blood pressure as an add-on to metformin in patients with type 2 diabetes.","AIMS


In EMPA-REG MET, in patients with type 2 diabetes mellitus (T2DM) on stable background metformin (≥1500 mg/day), empagliflozin versus placebo significantly improved glycated haemoglobin (HbA1c), body weight (BW), and systolic blood pressure (SBP) over 24 and ≤76 weeks. This analysis investigated empagliflozin treatment effects by baseline cardio-metabolic factors.
MATERIALS AND METHODS


Patients aged ≥18 years with HbA1c ≥7.0 to ≤10.0% were included. Analysis of covariance compared change from baseline to weeks 24 and 76 in HbA1c, BW, and SBP by respective baseline categories (HbA1c <8.5/≥8.5%; BW <80/80-90/>90 kg, SBP <130/130-140/>140 mmHg). Analyses were also conducted with a model using continuous covariates of cardio-metabolic factors.
RESULTS


In total, 637 patients (56.7% males; mean [SD] age 55.7 [9.9] years, HbA1c 7.9 [0.9] %, BW 81.2 [18.8] kg, SBP 129.4 [14.6] mmHg) received ≥1 dose of either empagliflozin 10 mg (n=217), or 25 mg (n=213), or placebo (n=207). At both time points, empagliflozin 10/25 mg versus placebo significantly (P<0.0001) reduced HbA1c and BW, with greater reductions in HbA1c at higher baseline HbA1c (P interaction week 24/76 categorical and continuous models: 0.0290/0.1431 and 0.0004/0.0042, respectively) and in BW (P interaction 0.1340/0.0012 and 0.0202/<0.0001, respectively). Both empagliflozin doses also significantly lowered SBP versus placebo at both time points, with similar efficacy by subgroups of baseline SBP. Adverse events were consistent with established empagliflozin safety profile across treatment groups.
CONCLUSIONS


Empagliflozin, as add-on to metformin, decreases HbA1c and BW, particularly in patients with higher HbA1c and BW baseline values, and effectively lowers SBP. This article is protected by copyright. All rights reserved.",2020,"At both time points, empagliflozin 10/25 mg versus placebo significantly (P<0.0001) reduced HbA1c and BW, with greater reductions in HbA1c at higher baseline HbA1c (P interaction week","['637 patients (56.7% males; mean [SD] age 55.7 [9.9] years, HbA1c 7.9 [0.9] %, BW 81.2 [18.8] kg, SBP 129.4 [14.6] mmHg', 'patients with type 2 diabetes', 'patients with type 2 diabetes mellitus (T2DM) on stable background', 'Patients aged ≥18\u2009years with HbA1c ≥7.0 to ≤10.0% were included']","['empagliflozin', 'empagliflozin versus placebo', 'metformin', 'placebo', 'Empagliflozin']","['glycated haemoglobin (HbA1c), body weight (BW), and systolic blood pressure (SBP', 'baseline HbA1c, body weight and blood pressure', 'Adverse events', 'HbA1c and BW', 'SBP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C4068881', 'cui_str': '0.9'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",637.0,0.142777,"At both time points, empagliflozin 10/25 mg versus placebo significantly (P<0.0001) reduced HbA1c and BW, with greater reductions in HbA1c at higher baseline HbA1c (P interaction week","[{'ForeName': 'Silvio E', 'Initials': 'SE', 'LastName': 'Inzucchi', 'Affiliation': 'Yale School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Melanie J', 'Initials': 'MJ', 'LastName': 'Davies', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester, UK.'}, {'ForeName': 'Kamlesh', 'Initials': 'K', 'LastName': 'Khunti', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester, UK.'}, {'ForeName': 'Prabhav', 'Initials': 'P', 'LastName': 'Trivedi', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Jyothis T', 'Initials': 'JT', 'LastName': 'George', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Zwiener', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.'}, {'ForeName': 'Odd Erik', 'Initials': 'OE', 'LastName': 'Johansen', 'Affiliation': 'Boehringer Ingelheim Norway KS, Asker, Norway.'}, {'ForeName': 'Naveed', 'Initials': 'N', 'LastName': 'Sattar', 'Affiliation': 'Institute of Cardiovascular & Medical Sciences, University of Glasgow, Glasgow, UK.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14234']
1841,33084475,A One-Session Treatment of PTSD After Single Sexual Assault Trauma. A Pilot Study of the WONSA MLI Project: A Randomized Controlled Trial.,"Sexual abuse is a crime with devastating health consequences. Accessible, acceptable and affordable treatment of PTSD after sexual abuse is important. In this pilot study, a one-session PTSD treatment and a modified perspective to PTSD treatment is introduced. The aim of the study was to test the efficacy of one session of Modified Lifespan Integration (MLI) on reduction of symptoms of PTSD in individuals with PTSD after one sexual assault. This was a single-center, individually randomized waitlist-controlled treatment study with 1:1 allocation, with the intervention of one 90 - 140 minutes session of MLI and with post-treatment follow-up at 3 weeks (time point two). All participants were females, mean age 24, with PTSD symptoms after one sexual assault during the past 5 years. Exclusion criteria were poor understanding of Swedish, multiple traumas, active substance abuse, active psychosis, ADHD, or autism spectrum disorder. Of 135 interested participants, 38 were finally included, 36 completed baseline measures and were included in the intent to treat analyses and 33 were analyzed per protocol. The primary outcome was the difference between the two trial arms in mean PTSD symptoms as measured by the Impact of Event Scale Revised (IES-R) at time point two. In the intervention arm, 72% no longer scored PTSD in per-protocol analysis, compared to 6% in the waiting list arm. IES-R scores were on average halved in the intervention arm (F=21.37, P<0.001), but were essentially unchanged in the waiting list arm. No adverse effects or drop-outs were seen. One session of Modified Lifespan Integration was an effective treatment with a low drop-out rate for females aged 15-65 with PTSD after one sexual assault. Provided that this result can be replicated, MLI should be offered to these patients in clinical settings. Registration number NCT03141047 was given 03/25/2016 at ClinicalTrials.gov (https://register.clinicaltrials.gov/).",2020,One session of Modified Lifespan Integration was an effective treatment with a low drop-out rate for females aged 15-65 with PTSD after one sexual assault.,"['females aged 15-65 with PTSD after one sexual assault', 'WONSA MLI Project', 'individuals with PTSD after one sexual assault', 'All participants were females, mean age 24, with PTSD symptoms after one sexual assault during the past 5 years', 'Of 135 interested participants, 38 were finally included, 36 completed baseline measures and were included in the intent to treat analyses and 33 were analyzed per protocol']","['Modified Lifespan Integration (MLI', 'PTSD']","['Impact of Event Scale Revised (IES-R', 'scored PTSD', 'mean PTSD symptoms', 'IES-R scores']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0237236', 'cui_str': 'Sexual assault'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0023980', 'cui_str': 'Longevity'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0023980', 'cui_str': 'Longevity'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}]","[{'cui': 'C3472482', 'cui_str': 'Impact of event scale revised'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",135.0,0.059394,One session of Modified Lifespan Integration was an effective treatment with a low drop-out rate for females aged 15-65 with PTSD after one sexual assault.,"[{'ForeName': 'Gita', 'Initials': 'G', 'LastName': 'Rajan', 'Affiliation': 'Karolinska Institutet, Huddinge, Sweden.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Wachtler', 'Affiliation': 'Karolinska Institutet, Huddinge, Sweden.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Svenska Kognitiva Institutet, Stockholm, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Wändell', 'Affiliation': 'Karolinska Institutet, Huddinge, Sweden.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Philips', 'Affiliation': 'Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Wahlström', 'Affiliation': 'Karolinska Institutet, Huddinge, Sweden.'}, {'ForeName': 'Carl Göran', 'Initials': 'CG', 'LastName': 'Svedin', 'Affiliation': 'Ersta Sköndal Bräcke University College, Stockholm, Sweden.'}, {'ForeName': 'Axel C', 'Initials': 'AC', 'LastName': 'Carlsson', 'Affiliation': 'Karolinska Institutet, Huddinge, Sweden.'}]",Journal of interpersonal violence,['10.1177/0886260520965973']
1842,33084477,Effects of a Physical Exercise Program on Patients Affected with Fibromyalgia.,"BACKGROUND


physical activity has been used for a number of years in the treatment of fibromyalgia (FM). The main objective of this study is to compare the effects of physical activity on 2 groups of women diagnosed with FM in terms of pain, quality of life and the impact of the condition on their daily lives.
METHODS


this was a randomized clinical trial to assess the effects of physical activity performed by subjects assigned to one of 2 groups on the scores of 3 questionnaires, the pain Visual Analog Scale (EVA), the Fibromyalgia Impact Questionnaire (FIQ) and the SF-36 health questionnaire administered before and after the intervention.
RESULTS


A total of 24 subjects were randomly assigned to each of the 2 study groups. No significant differences were found after the program of 3 months of physical activity ended.
CONCLUSIONS


Our study shows that a physical activity program with duration of less than 3 months does not significantly improve any of the factors studied.",2020,"No significant differences were found after the program of 3 months of physical activity ended.
","['Patients Affected with Fibromyalgia', '24 subjects']","['physical activity', 'Physical Exercise Program']","['pain, quality of life', 'pain Visual Analog Scale (EVA), the Fibromyalgia Impact Questionnaire (FIQ) and the SF-36 health questionnaire']","[{'cui': 'C0522476', 'cui_str': 'Patient affected'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",24.0,0.0615218,"No significant differences were found after the program of 3 months of physical activity ended.
","[{'ForeName': 'Glòria', 'Initials': 'G', 'LastName': 'Sauch Valmaña', 'Affiliation': ""Unitat de Suport a la Recerca Catalunya Central, Fundació Institut Universitari per a la recerca a l'Atenció Primària de Salut Jordi Gol i Gurina, (IDIAPJGol), Barcelona, Spain.""}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Vidal-Alaball', 'Affiliation': ""Unitat de Suport a la Recerca Catalunya Central, Fundació Institut Universitari per a la recerca a l'Atenció Primària de Salut Jordi Gol i Gurina, (IDIAPJGol), Barcelona, Spain.""}, {'ForeName': 'Pere Roura', 'Initials': 'PR', 'LastName': 'Poch', 'Affiliation': 'Consorci Hospitalari de Vic., Vic, (Barcelona), Spain.'}, {'ForeName': 'Jacobo Mendiroz', 'Initials': 'JM', 'LastName': 'Peña', 'Affiliation': ""Unitat de Suport a la Recerca Catalunya Central, Fundació Institut Universitari per a la recerca a l'Atenció Primària de Salut Jordi Gol i Gurina, (IDIAPJGol), Barcelona, Spain.""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Panadés Zafra', 'Affiliation': ""Centre d'Atenció Primària Anoia Rural. Institut Català de la Salut, Catalunya Central, Igualada, (Barcelona), Spain.""}, {'ForeName': 'Francesc Xavier', 'Initials': 'FX', 'LastName': 'Cantero Gómez', 'Affiliation': ""Centre d'Atenció Primària Igualada Urbà. Institut Català de la Salut, Catalunya Central, Igualada (Barcelona), Spain.""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Ruíz Comellas', 'Affiliation': 'Health Promotion in Rural Areas Research Group, Gerència Territorial de la Catalunya Central, Institut Català de la Salut, Sant Fruitós de Bages (Barcelona), Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Barranco Reixachs', 'Affiliation': 'Universitat de Lleida. Campus Igualada, Igualada (Barcelona), Spain.'}]",Journal of primary care & community health,['10.1177/2150132720965071']
1843,33084524,"Sleep Restriction in Elite Soccer Players: Effects on Explosive Power, Wellbeing, and Cognitive Function.","Purpose : To investigate the cognitive, physical, and perceptual effects of sleep restriction (SR) in soccer players following a night match.  Methods : In a crossover design, nine male soccer players from the English Premier League 2 (age, 21 ± 5 years; height, 1.80 ± 0.75 m; body mass, 74.2 ± 6.8 kg) recorded their sleep quality and quantity with sleep logs and a subjective survey after two night matches (19:00); one where sleep duration was not altered (CON) and one where sleep was restricted by a later bed-time (SR). Countermovement jump height (CMJ), subjective wellbeing (1-5 likert scale for mood, stress, fatigue, sleep, and soreness), and cognitive function were measured at baseline and the morning following the match (+12 h; M + 1).  Results : Bed-time was later in SR than CON (02:36 ± 0.17 vs. 22:43 ± 29;  P  = .0001; ηp 2  = 0.999) and sleep duration was shorter in SR than CON (5.37 ± 0.16 vs. 8.59 h ± 0.36;  P  = .0001; ηp 2  = 0.926). CMJ decreased by ~8% after the match in both SR and CON ( P  = .0001; ηp 2  = 0.915) but there were no differences between the conditions ( P  > .05; ηp 2  = 0.041-0.139). Wellbeing was rated worse after both matches ( P  = .0001; ηp 2  = 0.949) but there were no differences between the trials ( P  > .05; ηp 2  = 0.172-257). SR did not influence cognitive function ( P  > .05; interaction effects, ηp 2  = 0.172-257).  Conclusion : SR following a nighttime soccer match does not impair CMJ performance, subjective wellbeing, or cognitive function the following morning.",2020,Wellbeing was rated worse after both matches ( P  = .0001; ηp 2  = 0.949) but there were no differences between the trials ( P  > .05; ηp 2  = 0.172-257).,"['nine male soccer players from the English Premier League 2 (age, 21\xa0±\xa05\xa0years; height, 1.80\xa0±\xa00.75 m; body mass, 74.2\xa0±\xa06.8 kg) recorded their', 'Elite Soccer Players', 'soccer players following a night match']",['sleep restriction (SR'],"['Bed-time', 'CMJ', 'Explosive Power, Wellbeing, and Cognitive Function', 'Countermovement jump height (CMJ), subjective wellbeing (1-5 likert scale for mood, stress, fatigue, sleep, and soreness), and cognitive function', 'cognitive function', 'sleep duration', 'sleep quality and quantity with sleep logs and a subjective survey', 'CMJ performance, subjective wellbeing, or cognitive function']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C4068882', 'cui_str': '0.75'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}]","[{'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015330', 'cui_str': 'Explosive device'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0451267', 'cui_str': 'Likert scale'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0234233', 'cui_str': 'Soreness'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]",9.0,0.037743,Wellbeing was rated worse after both matches ( P  = .0001; ηp 2  = 0.949) but there were no differences between the trials ( P  > .05; ηp 2  = 0.172-257).,"[{'ForeName': 'W', 'Initials': 'W', 'LastName': 'Abbott', 'Affiliation': 'Brighton and Hove Albion F.C.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Brett', 'Affiliation': 'Brighton and Hove Albion F.C.'}, {'ForeName': 'A W', 'Initials': 'AW', 'LastName': 'Watson', 'Affiliation': 'Newcastle University.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Brooker', 'Affiliation': 'University of Exeter Medical School.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Clifford', 'Affiliation': 'Newcastle University.'}]",Research quarterly for exercise and sport,['10.1080/02701367.2020.1834071']
1844,33084560,Clinical handover from emergency medical services to the trauma team: A gap analysis.,"OBJECTIVES


There has been limited evaluation of handover from emergency medical services (EMS) to the trauma team. We sought to characterize these handover practices to identify areas of improvement and determine if handover standardization might be beneficial for trauma team performance.
METHODS


Data were prospectively collected over a nine-week period by a trained observer at a Canadian level one trauma centre. A randomized scheduled was used to capture a representative breadth of handovers. Data collected included outcome measures such as duration of handover, structure of the handover, and information shared, process measures such as questions and interruptions from the trauma team, and perceptions of the handover from nurses, trauma team leaders and EMS according to a bidirectional Likert scale.
RESULTS


79 formal verbal handovers were observed. Information was often missing regarding airway (present 22%), breathing (54%), medications (59%), and allergies (54%). Handover structure lacked consistency beyond the order of identification and mechanism of injury. Of all questions asked, 35% were questioning previously given information. The majority of handovers (61%) involved parallel conversations between team members while EMS was speaking. There was a statistically significant disparity between the self-evaluation of EMS handovers and the perceived quality determined by nurses and trauma team leaders.
CONCLUSIONS


We have identified the need to standardize handover due to poor information content, a lack of structure and active listening, information repetition, and discordant expectations between team members. These data will guide the development of a co-constructed framework integrating the perspectives of all team members.",2020,"There was a statistically significant disparity between the self-evaluation of EMS handovers and the perceived quality determined by nurses and trauma team leaders.
",['Data were prospectively collected over a nine-week period by a trained observer at a Canadian level one trauma centre'],[],"['duration of handover, structure of the handover, and information shared, process measures such as questions and interruptions from the trauma team, and perceptions of the handover from nurses, trauma team leaders and EMS according to a bidirectional Likert scale']","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040786', 'cui_str': 'Trauma center'}]",[],"[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0086850', 'cui_str': 'Process Measures'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0013961', 'cui_str': 'Emergency medical services'}, {'cui': 'C0451267', 'cui_str': 'Likert scale'}]",79.0,0.0591182,"There was a statistically significant disparity between the self-evaluation of EMS handovers and the perceived quality determined by nurses and trauma team leaders.
","[{'ForeName': 'Arshia P', 'Initials': 'AP', 'LastName': 'Javidan', 'Affiliation': 'Faculty of Medicine, University of Toronto, Toronto, ON.'}, {'ForeName': 'Avery B', 'Initials': 'AB', 'LastName': 'Nathens', 'Affiliation': 'Tory Regional Trauma Program and the Evaluative Clinical Sciences Program, Sunnybrook Research Institute, Toronto, ON.'}, {'ForeName': 'Homer', 'Initials': 'H', 'LastName': 'Tien', 'Affiliation': 'Tory Regional Trauma Program and the Evaluative Clinical Sciences Program, Sunnybrook Research Institute, Toronto, ON.'}, {'ForeName': 'Luis T', 'Initials': 'LT', 'LastName': 'da Luz', 'Affiliation': 'Tory Regional Trauma Program and the Evaluative Clinical Sciences Program, Sunnybrook Research Institute, Toronto, ON.'}]",CJEM,['10.1017/cem.2019.438']
1845,33086137,Effect of resin coating on highly viscous glass ionomer cements: A dynamic analysis.,"OBJECTIVES


This study determined the effects of self-adhesive resin coatings on viscoelastic properties of highly viscous glass ionomer cements (HVGICs) using dynamic mechanical analysis.
MATERIALS AND METHODS


The HVGICs evaluated were Zirconomer [ZR] (Shofu), Equia Forte [EQ] (GC) and Riva [RV] (SDI). Sixty specimens (12mm x 2mm x 2mm) of each material were fabricated using customized Teflon molds. After initial set, the specimens were removed from their molds, finished, measured and randomly divided into 3 groups of 20. Half the specimens in each group were left uncoated while the remaining half was covered with the respective manufacturers' resin coating. The specimens were subsequently conditioned in distilled water, artificial saliva or citric acid at 37°C for 7 days. The uncoated and coated specimens (n=10) were then subjected to dynamic mechanical testing in flexure mode at 37°C with a frequency of 0.1 to 10Hz. Storage modulus, loss modulus and loss tangent data were subjected to normality testing and statistical analysis using one-way ANOVA/Scheffe's post-hoc test and Ttest at significance level p<0.05.
RESULTS


Mean storage modulus ranged from 1.39 ± 0.36 to 10.80 ± 0.86 GPa while mean loss modulus varied from 0.13 ± 0.03 to 0.70 ± 0.14 GPa after conditioning in the different mediums. Values for loss tangent ranged from 39.4 ± 7.75 to 213.2 ± 20.11 (x10 -3 ). Significant differences in visco-elastic properties were observed between mediums and materials. When conditioned in distilled water and artificial saliva,storage modulus was significantly improved when ZR, EQ and RV were uncoated. Significantly higher values were, however, observed with resin coating when the materials were exposed to citric acid.
CONCLUSION


The visco-elastic properties of HVGICs were influenced by both resin coating and chemical environment.",2020,"When conditioned in distilled water and artificial saliva,storage modulus was significantly improved when ZR, EQ and RV were uncoated.",['highly viscous glass ionomer cements'],"['resin coating', 'self-adhesive resin coatings', 'distilled water, artificial saliva or citric acid']","['ZR, EQ and RV', 'Storage modulus, loss modulus and loss tangent data', 'visco-elastic properties', 'Zirconomer [ZR] (Shofu), Equia Forte [EQ] (GC) and Riva [RV] (SDI']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0017597', 'cui_str': 'Glass-ionomer dental material'}]","[{'cui': 'C0035191', 'cui_str': 'Resins, Plant'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0001516', 'cui_str': 'Adhesive'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0036088', 'cui_str': 'Artificial saliva'}, {'cui': 'C0055819', 'cui_str': 'Citric Acid'}]","[{'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0221839', 'cui_str': 'Orthodontic band, elastic'}, {'cui': 'C0871161', 'cui_str': 'Property'}]",,0.033953,"When conditioned in distilled water and artificial saliva,storage modulus was significantly improved when ZR, EQ and RV were uncoated.","[{'ForeName': 'A U', 'Initials': 'AU', 'LastName': 'Yap', 'Affiliation': 'Department of Dentistry, Ng Teng Fong General Hospital, National University Health System, Singapore; Department of Restorative Dentistry, Faculty of Dentistry, University of Malaya, Malaysia; Faculty of Dentistry, National University of Singapore, Singapore; Duke-NUS Medical School, Singapore; National Dental Research Institute Singapore, National Dental Centre Singapore, Singapore.'}, {'ForeName': 'J E', 'Initials': 'JE', 'LastName': 'Ong', 'Affiliation': 'Department of Restorative Dentistry, Faculty of Dentistry, University of Malaya, Malaysia.'}, {'ForeName': 'N A', 'Initials': 'NA', 'LastName': 'Yahya', 'Affiliation': 'Department of Restorative Dentistry, Faculty of Dentistry, University of Malaya, Malaysia. Electronic address: nazlin@um.edu.my.'}]",Journal of the mechanical behavior of biomedical materials,['10.1016/j.jmbbm.2020.104120']
1846,33086144,Behavioral activation with mindfulness in treating subthreshold depression in primary care: A cost-utility and cost-effectiveness analysis alongside a randomized controlled trial.,"This study aimed to assess the cost-utility and cost-effectiveness of group-based behavioral activation with mindfulness (BAM) versus care as usual (CAU) for treating subthreshold depression in primary care. Adults aged 18 years or older with subthreshold depression were randomized into two arms and were followed up for 12 months. BAM group was provided with eight 2-h weekly treatment by trained allied healthcare workers. CAU group could access to usual medical care but did not receive extra interventions. The health service cost in the past 12 months was self-reported by the participants. Quality-adjusted Life Years (QALYs) and clinical outcome (incidence of major depressive disorder progression) were measured. Willingness-to-pay ratio for cost-utility analysis (CUA) and cost-effectiveness analysis (CEA) was US$50,000 per QALY and US$20,000 per prevented major depression case, respectively. These ratios were used in the cost-effective acceptability curve analyses to estimate the probability of cost-effectiveness of the estimated incremental cost effectiveness ratios (ICER) of BAM versus CAU. A total of 115 and 116 participants were included in the BAM group and CAU respectively. The estimated CUA ICER was US5,979 per QALY and had a probability of 0.93 that BAM was cost-effective when compared to CAU. Furthermore, when compared to CAU, BAM was cost-effective in preventing progression of major depression: the estimated CEA ICER was US$1046 per preventable case of major progression with a probability of 0.99 to be cost-effective. Group-based BAM is considered as a cost-effective alternative treatment for treating subthreshold depression by preventing major depressive disorder.",2020,"The estimated CUA ICER was US5,979 per QALY and had a probability of 0.93 that BAM was cost-effective when compared to CAU.","['A total of 115 and 116 participants were included in the BAM group and CAU respectively', 'primary care', 'Adults aged 18 years or older with subthreshold depression']","['group-based behavioral activation with mindfulness (BAM) versus care as usual (CAU', 'CAU', 'BAM']","['estimated CUA ICER', 'health service cost', 'Quality-adjusted Life Years (QALYs) and clinical outcome (incidence of major depressive disorder progression', 'Willingness-to-pay ratio for cost-utility analysis (CUA) and cost-effectiveness analysis (CEA', 'cost-utility and cost-effectiveness']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]","[{'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C3853052', 'cui_str': 'Cost-Utility Analysis'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0018747', 'cui_str': 'Services, Health'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C1511536', 'cui_str': 'Cost-Effectiveness Analysis'}]",,0.0462248,"The estimated CUA ICER was US5,979 per QALY and had a probability of 0.93 that BAM was cost-effective when compared to CAU.","[{'ForeName': 'Yuying', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'The Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong, Hong Kong SAR, China; School of Public Health, The University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Samuel Y S', 'Initials': 'SYS', 'LastName': 'Wong', 'Affiliation': 'The Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Dexing', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'The Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Cynthia H J', 'Initials': 'CHJ', 'LastName': 'Chen', 'Affiliation': 'Saw Swee Hock School of Public Health, National University of Singapore, Singapore.'}, {'ForeName': 'Benjamin H K', 'Initials': 'BHK', 'LastName': 'Yip', 'Affiliation': 'The Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong, Hong Kong SAR, China. Electronic address: benyip@cuhk.edu.hk.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.10.006']
1847,33086145,Bifrontal high-frequency transcranial random noise stimulation is not effective as an add-on treatment in depression.,"BACKGROUND


Depressive disorders are linked to dysfunction in prefrontal cortical areas. Hence, non-invasive neurostimulation of the prefrontal cortex has demonstrated antidepressant efficacy. In the present study, we investigated the efficacy of high frequency transcranial random noise stimulation (hf-tRNS) as an add-on treatment for depression in a sham-controlled randomized trial.
METHODS


Forty in-patients with depression were randomized and treated with real or sham hf-tRNS (100-650 Hz) with 0 mA offset. The electrodes were mounted over the left and right dorsolateral prefrontal cortex. The Hamilton Depression Rating Scale (primary outcome), the Major Depression Inventory, the Clinical Global Impression scale and the Global Assessment of Functioning scale were used for assessment at baseline, after 3 weeks of intervention (end of treatment), and 9 weeks after intervention. Safety parameters included cognitive functioning and reported side-effects.
RESULTS


Comparison of real and sham treatment at the planned interim analysis showed an amelioration of symptoms in both groups for all outcomes with numeric but not statistically significant superiority of the sham arm for the primary outcome. Thus, the study was terminated prematurely after an interim analysis. There were no systematic differences with respect to safety parameters.
LIMITATIONS


The negative finding might be related to the specific stimulation parameters used in this study.
CONCLUSIONS


Our study suggests that prefrontal hf-tRNS is safe but not effective as an add-on treatment of depression. The challenge for future studies employing transcranial electric stimulation remains to identify effective stimulation parameters for the treatment of depression.",2020,"The Hamilton Depression Rating Scale (primary outcome), the Major Depression Inventory, the Clinical Global Impression scale and the Global Assessment of Functioning scale were used for assessment at baseline, after 3 weeks of intervention (end of treatment), and 9 weeks after intervention.",['Forty in-patients with depression'],"['transcranial electric stimulation', 'real or sham hf-tRNS', 'high frequency transcranial random noise stimulation (hf-tRNS']","['Hamilton Depression Rating Scale (primary outcome), the Major Depression Inventory, the Clinical Global Impression scale and the Global Assessment of Functioning scale', 'cognitive functioning and reported side-effects', 'amelioration of symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0442348', 'cui_str': 'Transcranial approach'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C3852967', 'cui_str': 'Transcranial Random Noise Stimulation'}]","[{'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C3639708', 'cui_str': 'Clinical global impression scale'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0424188,"The Hamilton Depression Rating Scale (primary outcome), the Major Depression Inventory, the Clinical Global Impression scale and the Global Assessment of Functioning scale were used for assessment at baseline, after 3 weeks of intervention (end of treatment), and 9 weeks after intervention.","[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Schecklmann', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Regensburg, Germany. Electronic address: martin.schecklmann@medbo.de.'}, {'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Nejati', 'Affiliation': 'Department of Psychology, Shahid Beheshti University, Iran.'}, {'ForeName': 'Timm B', 'Initials': 'TB', 'LastName': 'Poeppl', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Regensburg, Germany; Department of Psychiatry, Psychotherapy and Psychosomatics, Medical Faculty, RWTH Aachen University, Germany.'}, {'ForeName': 'Juliette', 'Initials': 'J', 'LastName': 'Peytard', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Regensburg, Germany.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Rupprecht', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Regensburg, Germany.'}, {'ForeName': 'Thomas C', 'Initials': 'TC', 'LastName': 'Wetter', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Regensburg, Germany.'}, {'ForeName': 'Berthold', 'Initials': 'B', 'LastName': 'Langguth', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Regensburg, Germany.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Kreuzer', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Regensburg, Germany.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.10.011']
1848,33086156,Model and approach for assessing implementation context and fidelity in the HEALing Communities Study.,"BACKGROUND


In response to the U.S. opioid epidemic, the HEALing (Helping to End Addiction Long-term SM ) Communities Study (HCS) is a multisite, wait-listed, community-level cluster-randomized trial that aims to test the novel Communities That HEAL (CTH) intervention, in 67 communities. CTH will expand an integrated set of evidence-based practices (EBPs) across health care, behavioral health, justice, and other community-based settings to reduce opioid overdose deaths. We present the rationale for and adaptation of the RE-AIM/PRISM framework and methodological approach used to capture the CTH implementation context and to evaluate implementation fidelity.
METHODS


HCS measures key domains of the internal and external CTH implementation context with repeated annual surveys and qualitative interviews with community coalition members and key stakeholders. Core constructs of fidelity include dosage, adherence, quality, and program differentiation-the adaptation of the CTH intervention to fit each community's needs. Fidelity measures include a monthly CTH checklist, collation of artifacts produced during CTH activities, coalition and workgroup attendance, and coalition meeting minutes. Training and technical assistance delivered by the research sites to the communities are tracked monthly.
DISCUSSION


To help attenuate the nation's opioid epidemic, the adoption of EBPs must be increased in communities. The HCS represents one of the largest and most complex implementation research experiments yet conducted. Our systematic examination of implementation context and fidelity will significantly advance understanding of how to best evaluate community-level implementation of EBPs and assess relations among implementation context, fidelity, and intervention impact.",2020,"CTH will expand an integrated set of evidence-based practices (EBPs) across health care, behavioral health, justice, and other community-based settings to reduce opioid overdose deaths.",[],"['CTH intervention', 'HEAL (CTH) intervention', 'CTH']","['monthly CTH checklist, collation of artifacts produced during CTH activities, coalition and workgroup attendance, and coalition meeting minutes']",[],"[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0085089', 'cui_str': 'Artifact'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0556656', 'cui_str': 'Meetings'}, {'cui': 'C0439232', 'cui_str': 'min'}]",,0.0247065,"CTH will expand an integrated set of evidence-based practices (EBPs) across health care, behavioral health, justice, and other community-based settings to reduce opioid overdose deaths.","[{'ForeName': 'Hannah K', 'Initials': 'HK', 'LastName': 'Knudsen', 'Affiliation': 'Department of Behavioral Science and Center on Drug and Alcohol Research, University of Kentucky, 845 Angliana Avenue, Room 204, Lexington, KY, 40508, USA. Electronic address: hannah.knudsen@uky.edu.'}, {'ForeName': 'Mari-Lynn', 'Initials': 'ML', 'LastName': 'Drainoni', 'Affiliation': 'Section of Infectious Diseases and Evans Center for Implementation and Improvement Sciences, Department of Medicine, Boston University School of Medicine, Department of Health Law, Policy and Management, Boston University School of Public Health, 801 Massachusetts Avenue, Room 2014, Boston, MA, 02118, USA. Electronic address: drainoni@bu.edu.'}, {'ForeName': 'Louisa', 'Initials': 'L', 'LastName': 'Gilbert', 'Affiliation': 'Social Intervention Group, Columbia University School of Social Work, 1255 Amsterdam Avenue, New York, NY, 10027, USA. Electronic address: lg123@columbia.edu.'}, {'ForeName': 'Timothy R', 'Initials': 'TR', 'LastName': 'Huerta', 'Affiliation': 'College of Medicine, The Ohio State University, 460 Medical Center Drive, Suite 530, Columbus, OH, 43210, USA. Electronic address: timothy.huerta@osumc.edu.'}, {'ForeName': 'Carrie B', 'Initials': 'CB', 'LastName': 'Oser', 'Affiliation': 'Department of Sociology and Center on Drug and Alcohol Research, University of Kentucky, 1531 Patterson Office Tower, Lexington, KY, 40506, USA. Electronic address: carrie.oser@uky.edu.'}, {'ForeName': 'Alison M', 'Initials': 'AM', 'LastName': 'Aldrich', 'Affiliation': 'CATALYST, the Center for the Advancement of Team Science, Analytics, and Systems Thinking in Health Services and Implementation Science Research, College of Medicine, The Ohio State University, 460 Medical Center Drive, Suite 530, Columbus, OH, 43210, USA. Electronic address: alison.aldrich@osumc.edu.'}, {'ForeName': 'Aimee N C', 'Initials': 'ANC', 'LastName': 'Campbell', 'Affiliation': 'Columbia University Irving Medical Center, Department of Psychiatry and New York State Psychiatric Institute, 1051 Riverside Drive, Box 120, New York, NY, 10032, USA. Electronic address: anc2002@cumc.columbia.edu.'}, {'ForeName': 'Erika L', 'Initials': 'EL', 'LastName': 'Crable', 'Affiliation': 'Evans Center for Implementation and Improvement Sciences, Department of Medicine, Boston University School of Medicine, Department of Health Law, Policy and Management, Boston University School of Public Health, 801 Massachusetts Avenue, Room 2030, Boston, MA, 02118, USA. Electronic address: ecrable@bu.edu.'}, {'ForeName': 'Bryan R', 'Initials': 'BR', 'LastName': 'Garner', 'Affiliation': 'RTI International, 3040 East Cornwallis Road, Research Triangle Park, NC, 27709-2194, USA. Electronic address: bgarner@rti.org.'}, {'ForeName': 'LaShawn M', 'Initials': 'LM', 'LastName': 'Glasgow', 'Affiliation': 'RTI International, 3040 East Cornwallis Road, Research Triangle Park, NC, 27709-2194, USA. Electronic address: lglasgow@rti.org.'}, {'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Goddard-Eckrich', 'Affiliation': 'Social Intervention Group, Columbia University School of Social Work, 1255 Amsterdam Avenue, New York, NY, 10027, USA. Electronic address: dg2121@columbia.edu.'}, {'ForeName': 'Katherine R', 'Initials': 'KR', 'LastName': 'Marks', 'Affiliation': 'Department of Behavioral Science, University of Kentucky, 1100 Veterans Drive, Medical Behavioral Science Building Room 108, Lexington, KY, 40536, USA. Electronic address: katie.marks@uky.edu.'}, {'ForeName': 'Ann Scheck', 'Initials': 'AS', 'LastName': 'McAlearney', 'Affiliation': 'Department of Family and Community Medicine and CATALYST, the Center for the Advancement of Team Science, Analytics, and Systems Thinking in Health Services and Implementation Science Research, College of Medicine, The Ohio State University, 460 Medical Center Drive, Suite 530, Columbus, OH, 43210, USA. Electronic address: ann.mcalearney@osumc.edu.'}, {'ForeName': 'Emmanuel A', 'Initials': 'EA', 'LastName': 'Oga', 'Affiliation': 'RTI International, 3040 East Cornwallis Road, Research Triangle Park, NC, 27709-2194, USA. Electronic address: eoga@rti.org.'}, {'ForeName': 'Ariel L', 'Initials': 'AL', 'LastName': 'Scalise', 'Affiliation': 'Department of Infectious Disease, Boston Medical Center, 801 Massachusetts Avenue, Boston, MA, 02118, USA. Electronic address: ariel.scalise@bmc.org.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Walker', 'Affiliation': 'Department of Family and Community Medicine, College of Medicine, The Ohio State University, 460 Medical Center Drive, Suite 520, Columbus, OH, 43210, USA. Electronic address: daniel.walker@osumc.edu.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108330']
1849,33086159,Using artificial intelligence tools in answering important clinical questions: The KEYNOTE-183 multiple myeloma experience.,"The phase III, randomized, active-controlled, multicenter, open-label KEYNOTE-183 study (NCT02576977) evaluating pomalidomide and low dose dexamethasone (standard-of-care [SOC]) with or without pembrolizumab in patients with refractory or relapsed and refractory multiple myeloma (rrMM) was placed on full clinical hold by the US FDA on July 03, 2017 due to an imbalance in the number of deaths between arms. Clinically-led subgroup analyses are typically used to shed light on clinical findings. However, this approach is not always successful. We propose a systematic approach using the artificial intelligence tools to identifying risk factors and subgroups contributing to the overall death (prognostic) or to the excess death observed in the pembrolizumab plus SOC arm (predictive) of the KEYNOTE-183 study. In KEYNOTE-183, with a data cutoff date of June 02, 2017, we identified plasmacytoma as a prognostic factor, and ECOG performance status as a predictive factor of death. In addition, a qualitative interaction was observed between ECOG performance status and the treatment arm. The subsequent subgroup analysis based on ECOG performance status confirmed that more deaths were associated with pembrolizumab plus SOC versus SOC alone in patients with ECOG performance status 1.",2020,The subsequent subgroup analysis based on ECOG performance status confirmed that more deaths were associated with pembrolizumab plus SOC versus SOC alone in patients with ECOG performance status 1.,['patients with refractory or relapsed and refractory multiple myeloma (rrMM'],['dexamethasone (standard-of-care [SOC]) with or without pembrolizumab'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C4551538', 'cui_str': 'Plasma cell myeloma refractory'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}]",[],,0.0440892,The subsequent subgroup analysis based on ECOG performance status confirmed that more deaths were associated with pembrolizumab plus SOC versus SOC alone in patients with ECOG performance status 1.,"[{'ForeName': 'Jason J Z', 'Initials': 'JJZ', 'LastName': 'Liao', 'Affiliation': 'Merck Sharp & Dohme Corp, a subsidiary of Merck & Co., Inc, Kenilworth, NJ, USA. Electronic address: a4statistics@gmail.com.'}, {'ForeName': 'Mohammed Z H', 'Initials': 'MZH', 'LastName': 'Farooqui', 'Affiliation': 'Merck Sharp & Dohme Corp, a subsidiary of Merck & Co., Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Marinello', 'Affiliation': 'Merck Sharp & Dohme Corp, a subsidiary of Merck & Co., Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Hartzel', 'Affiliation': 'Merck Sharp & Dohme Corp, a subsidiary of Merck & Co., Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Keaven', 'Initials': 'K', 'LastName': 'Anderson', 'Affiliation': 'Merck Sharp & Dohme Corp, a subsidiary of Merck & Co., Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Junshui', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Merck Sharp & Dohme Corp, a subsidiary of Merck & Co., Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Christine K', 'Initials': 'CK', 'LastName': 'Gause', 'Affiliation': 'Merck Sharp & Dohme Corp, a subsidiary of Merck & Co., Inc, Kenilworth, NJ, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106179']
1850,33084773,Effect of cryotherapy in preventing mucositis associated with the use of 5-fluorouracil.,"OBJECTIVE


to evaluate the effect of oral cryotherapy compared to physiological serum on the development of oral mucositis in outpatient cancer patients using the 5-fluorouracil antineoplastic agent.
METHOD


this is a controlled, randomized, double-blind, and multi-center clinical trial, conducted with 60 patients undergoing chemotherapy. The experimental group (n=30) used oral cryotherapy during the infusion of the 5-FU antineoplastic agent, while the control group (n=30) performed mouthwash with physiological serum at their homes. The oral cavity of the participants was assessed at three times: before randomization, and on the 7th and 14th days after using 5-FU. For data analysis, descriptive analyses and the ANOVA, paired t, and McNemar tests were used.
RESULTS


there was no statistically significant difference between the experimental and control groups in the assessments regarding the grade of mucositis. However, cryotherapy presented the chance to reduce the presence of intragroup mucositis, between the first and second assessments (p=0.000126).
CONCLUSION


cryotherapy did not obtain statistical significance in relation to oral hygiene with serum, but it proved to be effective intragroup. Record number: RBR-4k7zh3.",2020,there was no statistically significant difference between the experimental and control groups in the assessments regarding the grade of mucositis.,"['outpatient cancer patients using the 5-fluorouracil antineoplastic agent', '60 patients undergoing chemotherapy']","['5-fluorouracil', '5-FU', 'oral cryotherapy', '5-FU antineoplastic agent, while the control group (n=30) performed mouthwash with physiological serum at their homes', 'cryotherapy']","['oral mucositis', 'grade of mucositis', 'mucositis', 'presence of intragroup mucositis']","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0003392', 'cui_str': 'Antineoplastic agent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C4551716', 'cui_str': 'Cryotherapy'}, {'cui': 'C0003392', 'cui_str': 'Antineoplastic agent'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0026647', 'cui_str': 'Oromucosal solution for gargle'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]","[{'cui': 'C0038362', 'cui_str': 'Stomatitis'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0333355', 'cui_str': 'Inflammatory disease of mucous membrane'}, {'cui': 'C0150312', 'cui_str': 'Present'}]",60.0,0.0313439,there was no statistically significant difference between the experimental and control groups in the assessments regarding the grade of mucositis.,"[{'ForeName': 'Andrea Bezerra', 'Initials': 'AB', 'LastName': 'Rodrigues', 'Affiliation': 'Universidade Federal do Ceará, Departamento de Enfermagem, Fortaleza, CE, Brazil.'}, {'ForeName': 'Maria Isis Freire De', 'Initials': 'MIF', 'LastName': 'Aguiar', 'Affiliation': 'Universidade Federal do Ceará, Departamento de Enfermagem, Fortaleza, CE, Brazil.'}, {'ForeName': 'Patrícia Peres De', 'Initials': 'PP', 'LastName': 'Oliveira', 'Affiliation': 'Universidade Federal de São João Del Rey, Departamento de Enfermagem, Divinópolis, MG, Brazil.'}, {'ForeName': 'Naiana Pacifico', 'Initials': 'NP', 'LastName': 'Alves', 'Affiliation': 'Universidade Federal do Ceará, Departamento de Enfermagem, Fortaleza, CE, Brazil.'}, {'ForeName': 'Renan Alves', 'Initials': 'RA', 'LastName': 'Silva', 'Affiliation': 'Universidade Federal do Espírito Santo, Departamento de Ciências da Saúde, São Mateus, ES, Brazil.'}, {'ForeName': 'Willame De Oliveira', 'Initials': 'WO', 'LastName': 'Vitorino', 'Affiliation': 'Universidade Federal do Ceará, Departamento de Enfermagem, Fortaleza, CE, Brazil.'}, {'ForeName': 'Thays Silva De Souza', 'Initials': 'TSS', 'LastName': 'Lopes', 'Affiliation': 'Universidade Federal do Ceará, Departamento de Enfermagem, Fortaleza, CE, Brazil.'}]",Revista latino-americana de enfermagem,['10.1590/1518-8345.3953.3363']
1851,33084814,"Aqueous humor heat-shock protein 70, periostin, and irisin levels in patients with pseudoexfoliation syndrome.","PURPOSE


To measure humor heat-shock protein 70, periostin, and irisin levels in patients with pseudoexfoliation syndrome and cataract (without glaucoma), and compare them with those of patients with cataract but without pseudoexfoliation.
METHODS


We examined 31 eyes of 31 patients with pseudoexfoliation and cataract (without glaucoma) and 30 eyes of 30 patients with cataract. We collected aqueous humor samples from all patients at the time of cataract surgery through a limbal paracentesis via a 25-gauge cannula mounted on a tuberculin syringe that received 100 to 150 µL of aqueous humor. We measured levels of aqueous humor Heat shock protein 70, periostin, and irisin using enzyme-linked immunosorbent assay methods.
RESULTS


The age (p=0.221) and gender (p=0.530) means were similar between the pseudoexfoliation and control groups. The mean Heat shock protein 70 level (29.22 ± 9.46 ng/mL; 17.88-74.46) in the pseudoexfoliation group was significantly higher than that in the control group (19.03 ± 7.05 ng/mL; 9.93-35.52; p<0.0001). The mean periostin level was significantly higher (6017.32 ± 1271.79 pg/mL; 3787.50-10803.57) in the pseu doexfoliation group than that in the control group (4073.63 ± 1422.79 pg/mL; 2110.44-7490.64; p<0.0001). The mean irisin level (53.77 ± 10.19 ng/mL; 29.46-71.16) was significantly higher than that in the control group (39.29 ± 13.58 ng/mL; 19.41-70.56; p<0.0001).
CONCLUSIONS


Heat shock protein 70, periostin, and irisin levels increase in the aqueous humor of patients with pseudoexfoliation without glaucoma.",2020,The mean Heat shock protein 70 level (29.22 ± 9.46 ng/mL; 17.88-74.46) in the pseudoexfoliation group was significantly higher than that in the control group (19.03 ± 7.05 ng/mL; 9.93-35.52; p<0.0001).,"['31 eyes of 31 patients with pseudoexfoliation and cataract (without glaucoma) and 30 eyes of 30 patients with cataract', 'patients with pseudoexfoliation syndrome', 'patients with pseudoexfoliation without glaucoma', 'patients with cataract but without pseudoexfoliation', 'patients with pseudoexfoliation syndrome and cataract (without glaucoma']",['limbal paracentesis via a 25-gauge cannula mounted on a tuberculin syringe that received 100 to 150 µL of aqueous humor'],"['mean periostin level', 'mean irisin level', 'levels of aqueous humor Heat shock protein 70, periostin, and irisin using enzyme-linked immunosorbent assay methods', 'mean Heat shock protein 70 level']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086543', 'cui_str': 'Cataract'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0206368', 'cui_str': 'Pseudoexfoliation glaucoma'}]","[{'cui': 'C0443251', 'cui_str': 'Limbal'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0456638', 'cui_str': '25G'}, {'cui': 'C0520453', 'cui_str': 'Cannula'}, {'cui': 'C0181909', 'cui_str': 'Mount'}, {'cui': 'C0041289', 'cui_str': 'Tuberculin'}, {'cui': 'C0039142', 'cui_str': 'Syringe'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0003662', 'cui_str': 'Aqueous humor'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0219433', 'cui_str': 'POSTN protein, human'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0003662', 'cui_str': 'Aqueous humor'}, {'cui': 'C0243043', 'cui_str': 'Heat-Shock Proteins 70'}, {'cui': 'C0014441', 'cui_str': 'Enzyme-linked immunosorbent assay'}, {'cui': 'C0025663', 'cui_str': 'Method'}]",31.0,0.0729697,The mean Heat shock protein 70 level (29.22 ± 9.46 ng/mL; 17.88-74.46) in the pseudoexfoliation group was significantly higher than that in the control group (19.03 ± 7.05 ng/mL; 9.93-35.52; p<0.0001).,"[{'ForeName': 'Mete', 'Initials': 'M', 'LastName': 'Güler', 'Affiliation': 'Department of Ophthalmology, School of Medicine, Kahramanmaraş Sütçü İmam University, Kahramanmaraş, Turkey.'}, {'ForeName': 'Süleyman', 'Initials': 'S', 'LastName': 'Aydın', 'Affiliation': 'Department of Biochemistry, School of Medicine, Fırat University, Elazığ, Turkey.'}, {'ForeName': 'Selma', 'Initials': 'S', 'LastName': 'Urfalıoğlu', 'Affiliation': 'Department of Ophthalmology, School of Medicine, Kahramanmaraş Sütçü İmam University, Kahramanmaraş, Turkey.'}, {'ForeName': 'Meltem', 'Initials': 'M', 'LastName': 'Yardım', 'Affiliation': 'Department of Biochemistry, School of Medicine, Fırat University, Elazığ, Turkey.'}]",Arquivos brasileiros de oftalmologia,['10.5935/0004-2749.20200046']
1852,33084817,Three versus five intravitreal aflibercept injections as the initial loading phase in the treatment of diabetic macular edema: one-year results.,"PURPOSE


To compare the efficacy of three initial monthly intravitreal aflibercept injections followed by pro re nata (3+PRN) dosing versus five initial monthly intravitreal aflibercept injections followed by pro re nata (5+PRN) dosing in patients with diabetic macular edema.
METHODS


A total of 60 treatment-naïve patients with macular edema who underwent intravitreal aflibercept injections (2 mg/0.05 mL) with at least one year of follow-up were analyzed in this retrospective and comparative study. The patients were divided into two groups according to the number of intravitreal aflibercept injections administered in the loading phase. The 3+PRN group comprised 27 patients, whereas the 5+PRN group comprised 33 patients. The visual and anatomical outcomes were compared between the two groups at baseline and at 3, 6, 9, and 12 months.
RESULTS


Both 3+PRN and 5+PRN, showed statistically significant improvements in the best-corrected visual acuity and central macular thicknesse throughout the study period (p<0.001 and, p<0.001, respectively). There were no significant differences between the two groups in terms of changes in the best-corrected visual acuity and central macular thickness (p=0.453 and, p=0.784, respectively). The mean number of intravitreal aflibercept injections was significantly greater in the 5+PRN group (6.1 ± 0.8) than in the 3+PRN group (3.9 ± 0.8) (p<0.001).
CONCLUSION


The 3+PRN and 5+PRN regimens showed similar 12-month visual and anatomical outcomes following treatment with intravitreal aflibercept injections in patients with macular edema.",2020,"There were no significant differences between the two groups in terms of changes in the best-corrected visual acuity and central macular thickness (p=0.453 and, p=0.784, respectively).","['patients with macular edema', 'diabetic macular edema', 'patients with diabetic macular edema', '60 treatment-naïve patients with macular edema who underwent']","['5+PRN', 'intravitreal aflibercept injections', 'intravitreal aflibercept injections followed by pro re nata (3+PRN', 'aflibercept injections followed by pro re nata (5+PRN', '3+PRN']","['best-corrected visual acuity and central macular thickness', 'visual and anatomical outcomes', 'best-corrected visual acuity and central macular thicknesse', 'mean number of intravitreal aflibercept injections']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0271051', 'cui_str': 'Macular retinal edema'}, {'cui': 'C0730285', 'cui_str': 'Macular edema due to diabetes mellitus'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C4050106', 'cui_str': 'aflibercept Injection'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0067792', 'cui_str': 'N-acetyltryptophanamide'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C4050106', 'cui_str': 'aflibercept Injection'}]",60.0,0.0149357,"There were no significant differences between the two groups in terms of changes in the best-corrected visual acuity and central macular thickness (p=0.453 and, p=0.784, respectively).","[{'ForeName': 'Akin', 'Initials': 'A', 'LastName': 'Cakir', 'Affiliation': 'Department of Ophthalmology, University of Health Sciences, Okmeydani Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Burak', 'Initials': 'B', 'LastName': 'Erden', 'Affiliation': 'Department of Ophthalmology, University of Health Sciences, Okmeydani Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Selim', 'Initials': 'S', 'LastName': 'Bolukbasi', 'Affiliation': 'Department of Ophthalmology, University of Health Sciences, Okmeydani Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Ozkan', 'Initials': 'O', 'LastName': 'Sever', 'Affiliation': 'Department of Ophthalmology, Namik Kemal University, Tekirdağ, Turkey.'}, {'ForeName': 'Sezin Ozdogan', 'Initials': 'SO', 'LastName': 'Erkul', 'Affiliation': 'Department of Ophthalmology, University of Health Sciences, Istanbul Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Ozen Ayranci', 'Initials': 'OA', 'LastName': 'Osmanbasoglu', 'Affiliation': 'Department of Ophthalmology, University of Health Sciences, Istanbul Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Gulderen', 'Initials': 'G', 'LastName': 'Karaca', 'Affiliation': 'Department of Ophthalmology, University of Health Sciences, Okmeydani Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Mustafa Nuri', 'Initials': 'MN', 'LastName': 'Elcioglu', 'Affiliation': 'Department of Ophthalmology, University of Health Sciences, Okmeydani Training and Research Hospital, Istanbul, Turkey.'}]",Arquivos brasileiros de oftalmologia,['10.5935/0004-2749.20200078']
1853,33084818,"Immune modulator therapy compared with vitrectomy for management of complicated intermediate uveitis: a prospective, randomized clinical study.","PURPOSE


To compare the benefits and side effects of pars plana vitrectomy with those of systemic immune modulator therapy for patients with complicated intermediate uveitis.
METHODS


This prospective clinical trial enrolled patients with recurrent intermediate uveitis who exhibited minimal improvement of visual acuity, despite injections of periocular steroids. Twenty patients were randomized to the pars plana vitrectomy group or oral steroid and cyclosporine-A group (10 eyes of 10 patients per group). Follow-up was performed for 24 months to study changes in visual acuity, binocular indirect ophthalmoscopy score, fluorescein angiography, and optical coherence tomography findings.
RESULTS


Visual acuity (logarithm of the minimal angle of resolution) significantly improved from 0.71 to 0.42 (p=0.001) in the surgical group, whereas it improved from 0.68 to 0.43 (p=0.001) in the immune modulator therapy group. Seven patients (70%) in the surgical group gained ≥2 lines, and six patients (60%) in the immune modulator therapy group gained ≥2 lines (p=0.970). Fluorescein angiography and optical coherence tomography studies showed that six of seven pars plana vitrectomy patients who had cystoid macular edema experienced improvement, whereas two patients with diffuse macular edema did not experience improvement. In the immune modulator therapy group, three of six patients with cystoid macular edema did not experience improvement, whereas two patients with diffuse macular edema experienced improvement.
CONCLUSIONS


Pars plana vitrectomy and immune modulator therapy resulted in significant improvement in visual function in patients with persistent inflammation secondary to chronic intermediate uveitis. Despite this success, there remains a need for the determination of optimal indications for the use of each modality. Immune modulator therapy was successful for the treatment of diffuse macular edema associated with chronic intermediate uveitis, whereas pars plana vitrectomy was not.",2020,"CONCLUSIONS


Pars plana vitrectomy and immune modulator therapy resulted in significant improvement in visual function in patients with persistent inflammation secondary to chronic intermediate uveitis.","['complicated intermediate uveitis', 'patients with complicated intermediate uveitis', 'patients with persistent inflammation secondary to chronic intermediate uveitis', 'Twenty patients', 'patients with recurrent intermediate uveitis who exhibited minimal improvement of visual acuity, despite injections of periocular steroids']","['Immune modulator therapy', 'pars plana vitrectomy', 'Pars plana vitrectomy and immune modulator therapy', 'vitrectomy', 'Fluorescein angiography', 'systemic immune modulator therapy', 'pars plana vitrectomy group or oral steroid and cyclosporine-A group']","['Visual acuity (logarithm of the minimal angle of resolution', 'visual function', 'visual acuity, binocular indirect ophthalmoscopy score, fluorescein angiography, and optical coherence tomography findings', 'cystoid macular edema']","[{'cui': 'C0231242', 'cui_str': 'Complicated'}, {'cui': 'C0042166', 'cui_str': 'Intermediate uveitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1265824', 'cui_str': 'Persistent inflammation'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0015272', 'cui_str': 'Exhibits as Topic'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}]","[{'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0563537', 'cui_str': 'Mechanical vitrectomy by pars plana approach'}, {'cui': 'C0042903', 'cui_str': 'Vitrectomy'}, {'cui': 'C0016313', 'cui_str': 'Fluorescein angiography of eye'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0010592', 'cui_str': 'Cyclosporine'}]","[{'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C1444584', 'cui_str': 'Binocular indirect ophthalmoscopy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0016313', 'cui_str': 'Fluorescein angiography of eye'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0024440', 'cui_str': 'Cystoid macular edema'}]",20.0,0.026986,"CONCLUSIONS


Pars plana vitrectomy and immune modulator therapy resulted in significant improvement in visual function in patients with persistent inflammation secondary to chronic intermediate uveitis.","[{'ForeName': 'Osama', 'Initials': 'O', 'LastName': 'Shalaby', 'Affiliation': 'Ophthalmology department, Faculty of Medicine, Benha University, Benha City, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Saeed', 'Affiliation': 'Ophthalmology department, Faculty of Medicine, Benha University, Benha City, Egypt.'}, {'ForeName': 'Mohamed Nagy', 'Initials': 'MN', 'LastName': 'Elmohamady', 'Affiliation': 'Ophthalmology department, Faculty of Medicine, Benha University, Benha City, Egypt.'}]",Arquivos brasileiros de oftalmologia,['10.5935/0004-2749.20200079']
1854,33084829,Problematization educational intervention to promote healthy habits in elderly people with diabetes: randomized clinical trial.,"OBJECTIVE


to assess the effects of a problematization educational intervention to promote healthy habits in elderly people with diabetes.
METHODS


a randomized clinical trial conducted with 202 individuals drawn for the intervention group and the control group. The intervention consisted of problematization educational activities on a monthly basis for over six months. The control group participated in conventional monitoring at the health unit. Data were collected through semi-structured interviews before and after the intervention, in addition to laboratory tests.
RESULTS


after the intervention, when compared to the control group, there was an increase in knowledge about the disease (p<0.001), positive attitude towards self-care (p=0.011), physical activity (p=0.020), diet variety (p=0.002), and lower consumption of oils and fats (p<0.05).
CONCLUSION


the intervention performed has a beneficial effect to promote healthy habits.",2020,"RESULTS


after the intervention, when compared to the control group, there was an increase in knowledge about the disease (p<0.001), positive attitude towards self-care (p=0.011), physical activity (p=0.020), diet variety (p=0.002), and lower consumption of oils and fats (p<0.05).
","['202 individuals drawn for the intervention group and the control group', 'elderly people with diabetes']","['problematization educational intervention', 'problematization educational activities', 'conventional monitoring at the health unit', 'Problematization educational intervention']","['knowledge about the disease (p<0.001), positive attitude towards self-care (p=0.011), physical activity (p=0.020), diet variety (p=0.002), and lower consumption of oils and fats (p<0.05']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0013113', 'cui_str': 'Drawings'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013652', 'cui_str': 'Educational activities'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439148', 'cui_str': 'Unit'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0237428', 'cui_str': 'Positive attitude'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0452829', 'cui_str': 'Dietary fats and oils'}]",202.0,0.0642729,"RESULTS


after the intervention, when compared to the control group, there was an increase in knowledge about the disease (p<0.001), positive attitude towards self-care (p=0.011), physical activity (p=0.020), diet variety (p=0.002), and lower consumption of oils and fats (p<0.05).
","[{'ForeName': 'Anna Karla de Oliveira Tito', 'Initials': 'AKOT', 'LastName': 'Borba', 'Affiliation': 'Universidade Federal de Pernambuco. Recife, Pernambuco, Brazil.'}, {'ForeName': 'Ilma Kruze Grande de', 'Initials': 'IKG', 'LastName': 'Arruda', 'Affiliation': 'Universidade Federal de Pernambuco. Recife, Pernambuco, Brazil.'}, {'ForeName': 'Ana Paula de Oliveira', 'Initials': 'APO', 'LastName': 'Marques', 'Affiliation': 'Universidade Federal de Pernambuco. Recife, Pernambuco, Brazil.'}, {'ForeName': 'Márcia Carrera Campos', 'Initials': 'MCC', 'LastName': 'Leal', 'Affiliation': 'Universidade Federal de Pernambuco. Recife, Pernambuco, Brazil.'}, {'ForeName': 'Alcides da Silva', 'Initials': 'ADS', 'LastName': 'Diniz', 'Affiliation': 'Universidade Federal de Pernambuco. Recife, Pernambuco, Brazil.'}, {'ForeName': 'Francisca Márcia Pereira', 'Initials': 'FMP', 'LastName': 'Linhares', 'Affiliation': 'Universidade Federal de Pernambuco. Recife, Pernambuco, Brazil.'}]",Revista brasileira de enfermagem,['10.1590/0034-7167-2019-0719']
1855,33084880,Rationale and design of the genotype-blinded trial of torasemide for the treatment of hypertension (BHF UMOD).,"BACKGROUND


There is evidence from genome wide association study that single-nucleotide polymorphisms (SNPs) in the 5' end of the uromodulin gene (UMOD) affect uromodulin excretion and blood pressure (BP). Uromodulin is almost exclusively expressed in the thick ascending limb of the loop of Henle (TAL) and its effect on BP appear to be mediated via the TAL sodium transporter, NKCC2. Loop-diuretics block NKCC2 but are not commonly used in hypertension management. As volume overload is considered as one of the primary drivers for uncontrolled hypertension, targeting loop-diuretics to individuals who are more likely to respond to this drug class, using UMOD genotype, could be an efficient precision medicine strategy.
METHODS


A genotype-blinded, multi-centre trial comparing the BP response to torasemide between individuals possessing the AA genotype of the SNP rs13333226 and those possessing the G allele. 240 participants with uncontrolled BP aged ≥18 years, on ≥1 antihypertensive agent for ≥3 months, will be included. Uncontrolled BP is average systolic BP (SBP) >135mmHg and/or diastolic BP >85mmHg on home monitoring. Torasemide, 5mg daily, is taken for 16 weeks. The primary outcome is the change in 24h ambulatory SBP area under the curve between baseline and end of treatment. Sample size was calculated to detect a 4mmHg difference between groups at 90% power. Approval by West of Scotland Research Ethics Committee 5 (16/WS/0160). Registration at https://clinicaltrials.gov/ct2/show/NCT03354897.
RESULTS


The study should conclude August 2021.
CONCLUSIONS


If hypothesis confirmed, a targeted strategy will improve BP control and could reduce the burden of uncontrolled hypertension.",2020,"Uromodulin is almost exclusively expressed in the thick ascending limb of the loop of Henle (TAL) and its effect on BP appear to be mediated via the TAL sodium transporter, NKCC2.","['240 participants with uncontrolled BP aged ≥18 years, on ≥1 antihypertensive agent for ≥3 months, will be included', 'individuals possessing the AA genotype of the SNP rs13333226 and those possessing the G allele', 'hypertension (BHF UMOD']","['torasemide', 'Torasemide']","['uromodulin excretion and blood pressure (BP', 'change in 24h ambulatory SBP area under the curve between baseline and end of treatment', 'average systolic BP (SBP) ', 'Sample size']","[{'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C0752046', 'cui_str': 'Single Nucleotide Polymorphism'}, {'cui': 'C0002085', 'cui_str': 'Genetic alleles'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0077918', 'cui_str': 'Uromucoid protein'}, {'cui': 'C0017337', 'cui_str': 'Gene'}]","[{'cui': 'C0076840', 'cui_str': 'torsemide'}]","[{'cui': 'C0077918', 'cui_str': 'Uromucoid protein'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1282151', 'cui_str': 'Average systolic blood pressure'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}]",240.0,0.257686,"Uromodulin is almost exclusively expressed in the thick ascending limb of the loop of Henle (TAL) and its effect on BP appear to be mediated via the TAL sodium transporter, NKCC2.","[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'McCallum', 'Affiliation': 'Institute for Cardiovascular and Medical Sciences, BHF Glasgow Cardiovascular Research Centre, University Place, Glasgow.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Brooksbank', 'Affiliation': 'Institute for Cardiovascular and Medical Sciences, BHF Glasgow Cardiovascular Research Centre, University Place, Glasgow.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'McConnachie', 'Affiliation': 'Robertson Centre for Biostatistics, Institute of Health and Wellbeing, University of Glasgow, Boyd Orr Building, University Avenue, Glasgow.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Aman', 'Affiliation': 'Institute for Cardiovascular and Medical Sciences, BHF Glasgow Cardiovascular Research Centre, University Place, Glasgow.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Lip', 'Affiliation': 'Institute for Cardiovascular and Medical Sciences, BHF Glasgow Cardiovascular Research Centre, University Place, Glasgow.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Dawson', 'Affiliation': 'Institute for Cardiovascular and Medical Sciences, BHF Glasgow Cardiovascular Research Centre, University Place, Glasgow.'}, {'ForeName': 'I M', 'Initials': 'IM', 'LastName': 'MacIntyre', 'Affiliation': 'Clinical Pharmacology Unit and Research Centre, University of Edinburgh/BHF Centre of Research Excellence, Edinburgh Bioquarter, Edinburgh.'}, {'ForeName': 'T M', 'Initials': 'TM', 'LastName': 'MacDonald', 'Affiliation': 'MEMO Research, University of Dundee, Ninewells Hospital and Medical School, Dundee.'}, {'ForeName': 'D J', 'Initials': 'DJ', 'LastName': 'Webb', 'Affiliation': 'Clinical Pharmacology Unit and Research Centre, University of Edinburgh/BHF Centre of Research Excellence, Edinburgh Bioquarter, Edinburgh.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Padmanabhan', 'Affiliation': 'Institute for Cardiovascular and Medical Sciences, BHF Glasgow Cardiovascular Research Centre, University Place, Glasgow.'}]",American journal of hypertension,['10.1093/ajh/hpaa166']
1856,33084881,Patient-Reported Outcomes of Robotic vs Laparoscopic Ventral Hernia Repair With Intraperitoneal Mesh: The PROVE-IT Randomized Clinical Trial.,"Importance


Despite rapid adoption of the robotic platform for ventral hernia repair with intraperitoneal mesh in the United States, there is no level I evidence comparing it with the traditional laparoscopic approach. This randomized clinical trial sought to demonstrate a clinical benefit to the robotic approach.
Objective


To determine whether robotic approach to ventral hernia repair with intraperitoneal mesh would result in less postoperative pain.
Design, Setting, and Participants


A registry-based, single-blinded, prospective randomized clinical trial at the Cleveland Clinic Center for Abdominal Core Health, Cleveland, Ohio, completed between September 2017 and January 2020, with a minimum follow-up duration of 30 days. Two surgeons at 1 academic tertiary care hospital. Patients with primary or incisional midline ventral hernias of an anticipated width of 7 cm or less presenting in the elective setting and able to tolerate a minimally invasive repair.
Interventions


Patients were randomized to a standardized laparoscopic or robotic ventral hernia repair with fascial closure and intraperitoneal mesh.
Main Outcomes and Measures


The trial was powered to detect a 30% difference in the Numerical Rating Scale (NRS-11) on the first postoperative day. Secondary end points included the Patient-Reported Outcomes Measurement Information System Pain Intensity short form (3a), hernia-specific quality of life, operative time, wound morbidity, recurrence, length of stay, and cost.
Results


Seventy-five patients completed their minimally invasive hernia repair: 36 laparoscopic and 39 robotic. Baseline demographics and hernia characteristics were comparable. Robotic operations had a longer median operative time (146 vs 94 minutes; P < .001). There were 2 visceral injuries in each cohort but no full-thickness enterotomies or unplanned reoperations. There were no significant differences in NRS-11 scores preoperatively or on postoperative days 0, 1, 7, or 30. Specifically, median NRS-11 scores on the first postoperative day were the same (5 vs 5; P = .61). Likewise, postoperative Patient-Reported Outcomes Measurement Information System 3a and hernia-specific quality-of-life scores, as well as length of stay and complication rates, were similar. The robotic platform adds cost (total cost ratio, 1.13 vs 0.97; P = .03), driven by the cost of additional operating room time (1.25 vs 0.85; P < .001).
Conclusions and Relevance


Laparoscopic and robotic ventral hernia repair with intraperitoneal mesh have comparable outcomes. The increased operative time and proportional cost of the robotic approach are not offset by a measurable clinical benefit.
Trial Registration


ClinicalTrials.gov Identifier: NCT03283982.",2020,There were 2 visceral injuries in each cohort but no full-thickness enterotomies or unplanned reoperations.,"['Patients with primary or incisional midline ventral hernias of an anticipated width of 7 cm or less presenting in the elective setting and able to tolerate a minimally invasive repair', 'Two surgeons at 1 academic tertiary care hospital']","['standardized laparoscopic or robotic ventral hernia repair with fascial closure and intraperitoneal mesh', 'Robotic vs Laparoscopic Ventral Hernia Repair With Intraperitoneal Mesh', 'robotic platform', 'robotic approach to ventral hernia repair with intraperitoneal mesh', 'Laparoscopic and robotic ventral hernia repair with intraperitoneal mesh']","['median operative time', 'NRS-11 scores', 'Likewise, postoperative Patient-Reported Outcomes Measurement Information System 3a and hernia-specific quality-of-life scores', 'Baseline demographics and hernia characteristics', 'Numerical Rating Scale (NRS-11', 'median NRS-11 scores', 'Patient-Reported Outcomes Measurement Information System Pain Intensity short form (3a), hernia-specific quality of life, operative time, wound morbidity, recurrence, length of stay, and cost', 'length of stay and complication rates', 'cost of additional operating room time', 'operative time and proportional cost']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0019326', 'cui_str': 'Hernia of anterior abdominal wall'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0019334', 'cui_str': 'Repair of ventral hernia'}, {'cui': 'C0015641', 'cui_str': 'Fascial'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0442120', 'cui_str': 'Intraperitoneal'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0021428', 'cui_str': 'Information system'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205351', 'cui_str': 'Proportional'}]",,0.4073,There were 2 visceral injuries in each cohort but no full-thickness enterotomies or unplanned reoperations.,"[{'ForeName': 'Clayton C', 'Initials': 'CC', 'LastName': 'Petro', 'Affiliation': 'Cleveland Clinic Center for Abdominal Core Health, Digestive Diseases and Surgery Institute, The Cleveland Clinic Foundation, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Zolin', 'Affiliation': 'Cleveland Clinic Center for Abdominal Core Health, Digestive Diseases and Surgery Institute, The Cleveland Clinic Foundation, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Krpata', 'Affiliation': 'Cleveland Clinic Center for Abdominal Core Health, Digestive Diseases and Surgery Institute, The Cleveland Clinic Foundation, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Hemasat', 'Initials': 'H', 'LastName': 'Alkhatib', 'Affiliation': 'Cleveland Clinic Center for Abdominal Core Health, Digestive Diseases and Surgery Institute, The Cleveland Clinic Foundation, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Tu', 'Affiliation': 'Lerner Research Institute, Department of Quantitative Health Sciences, The Cleveland Clinic Foundation, Cleveland, Ohio.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Rosen', 'Affiliation': 'Cleveland Clinic Center for Abdominal Core Health, Digestive Diseases and Surgery Institute, The Cleveland Clinic Foundation, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Ajita S', 'Initials': 'AS', 'LastName': 'Prabhu', 'Affiliation': 'Cleveland Clinic Center for Abdominal Core Health, Digestive Diseases and Surgery Institute, The Cleveland Clinic Foundation, Cleveland Clinic, Cleveland, Ohio.'}]",JAMA surgery,['10.1001/jamasurg.2020.4569']
1857,33084901,Effect of the Wingman-Connect Upstream Suicide Prevention Program for Air Force Personnel in Training: A Cluster Randomized Clinical Trial.,"Importance


Suicide has been a leading manner of death for US Air Force personnel in recent years. Universal prevention programs that reduce suicidal thoughts and behaviors in military populations have not been identified.
Objectives


To determine whether the Wingman-Connect program for Airmen-in-training reduces suicidal ideation, depression, and occupational problems compared with a stress management program and to test the underlying network health model positing that cohesive, healthy units are protective against suicidal ideation.
Design, Setting, and Participants


This cluster randomized clinical trial was conducted from October 2017 to October 2019 and compared classes of personnel followed up for 6 months. The setting was a US Air Force technical training school, with participants studied to their first base assignment, whether US or international. Participants in 216 classes were randomized, with an 84% retention rate. Data analysis was performed from November 2019 to May 2020.
Interventions


The Wingman-Connect program used group skill building for cohesion, shared purpose, and managing career and personal stressors (3 blocks of 2 hours each). Stress management training covered cognitive and behavioral strategies (2 hours). Both conditions had a 1-hour booster session, plus text messages.
Main Outcomes and Measures


The primary outcomes were scores on the suicidal ideation and depression scales of the Computerized Adaptive Test for Mental Health and self-reports of military occupational impairment. Class network protective factors hypothesized to mediate the effect of Wingman-Connect were assessed with 4 measures: cohesion assessed perceptions that classmates cooperate, work well together, and support each other; morale was measured with a single item used in other studies with military samples; healthy class norms assessed perceptions of behaviors supported by classmates; and bonds to classmates were assessed by asking each participant to name classmates whom they respect and would choose to spend time with.
Results


A total of 215 classes including 1485 individuals (1222 men [82.3%]; mean [SD] age, 20.9 [3.1] years) participated; 748 individuals were enrolled in the Wingman-Connect program and 737 individuals were enrolled in the stress management program. At 1 month, the Wingman-Connect group reported lower suicidal ideation severity (effect size [ES], -0.23; 95% CI, -0.39 to -0.09; P = .001) and depression symptoms (ES, -0.24; 95% CI, -0.41 to -0.08; P = .002) and fewer occupational problems (ES, -0.14; 95% CI, -0.31 to -0.02; P = .02). At 6 months, the Wingman-Connect group reported lower depression symptoms (ES, -0.16; 95% CI, -0.34 to -0.02; P = .03), whereas the difference in suicidal ideation severity was not significant (ES, -0.13; 95% CI, -0.29 to 0.01; P = .06). The number needed to treat to produce 1 fewer participant with elevated depression at either follow-up point was 21. The benefits of the training on occupational problems did not extend past 1 month. The Wingman-Connect program strengthened cohesive, healthy class units, which helped reduce suicidal ideation severity (estimate, -0.035; 95% CI, -0.07 to -0.01; P = .02) and depression symptom scores (estimate, -0.039; 95% CI, -0.07 to -0.01; P = .02) at 1 month.
Conclusions and Relevance


Wingman-Connect is the first universal prevention program to reduce suicidal ideation and depression symptoms in a general Air Force population. Group training that builds cohesive, healthy military units is promising for upstream suicide prevention and may be essential for ecological validity. Extension of the program to the operational Air Force is recommended for maintaining continuity and testing the prevention impact on suicidal behavior.
Trial Registration


ClinicalTrials.gov Identifier: NCT04067401.",2020,"At 6 months, the Wingman-Connect group reported lower depression symptoms (ES, -0.16; 95% CI, -0.34 to -0.02; P = .03), whereas the difference in suicidal ideation severity was not significant (ES, -0.13; 95% CI, -0.29 to 0.01; P = .06).","['Air Force Personnel in Training', 'Participants in 216 classes', 'A total of 215 classes including 1485 individuals (1222 men [82.3%]; mean [SD] age, 20.9 [3.1] years) participated; 748 individuals were enrolled in the Wingman-Connect program and 737 individuals were enrolled in the stress management program']",['Wingman-Connect Upstream Suicide Prevention Program'],"['occupational problems', 'depression symptoms', 'suicidal ideation, depression, and occupational problems', 'suicidal ideation severity', 'depression symptom scores', 'suicidal ideation and depression symptoms', 'suicidal thoughts and behaviors', 'suicidal ideation and depression scales of the Computerized Adaptive Test for Mental Health and self-reports of military occupational impairment']","[{'cui': 'C0392328', 'cui_str': 'Air Force Personnel'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C4708905', 'cui_str': '216'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4709308', 'cui_str': '215'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517683', 'cui_str': '3.1'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0150788', 'cui_str': 'Stress management'}]","[{'cui': 'C0522505', 'cui_str': 'Upstream'}, {'cui': 'C0204732', 'cui_str': 'Suicide prevention'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0521127', 'cui_str': 'Occupational'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}]",216.0,0.160435,"At 6 months, the Wingman-Connect group reported lower depression symptoms (ES, -0.16; 95% CI, -0.34 to -0.02; P = .03), whereas the difference in suicidal ideation severity was not significant (ES, -0.13; 95% CI, -0.29 to 0.01; P = .06).","[{'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Wyman', 'Affiliation': 'Department of Psychiatry, University of Rochester School of Medicine and Dentistry, Rochester, New York.'}, {'ForeName': 'Anthony R', 'Initials': 'AR', 'LastName': 'Pisani', 'Affiliation': 'Department of Psychiatry, University of Rochester School of Medicine and Dentistry, Rochester, New York.'}, {'ForeName': 'C Hendricks', 'Initials': 'CH', 'LastName': 'Brown', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Yates', 'Affiliation': 'Department of Psychiatry, University of Rochester School of Medicine and Dentistry, Rochester, New York.'}, {'ForeName': 'Lacy', 'Initials': 'L', 'LastName': 'Morgan-DeVelder', 'Affiliation': 'Department of Psychiatry, University of Rochester School of Medicine and Dentistry, Rochester, New York.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Schmeelk-Cone', 'Affiliation': 'Department of Psychiatry, University of Rochester School of Medicine and Dentistry, Rochester, New York.'}, {'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'Gibbons', 'Affiliation': 'Department of Medicine, Biological Sciences, The University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Caine', 'Affiliation': 'Department of Psychiatry, University of Rochester School of Medicine and Dentistry, Rochester, New York.'}, {'ForeName': 'Mariya', 'Initials': 'M', 'LastName': 'Petrova', 'Affiliation': 'Department of Psychiatry, University of Rochester School of Medicine and Dentistry, Rochester, New York.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Neal-Walden', 'Affiliation': ""US Air Force Surgeon General's Office, Falls Church, Virginia.""}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Linkh', 'Affiliation': ""US Air Force Surgeon General's Office, Falls Church, Virginia.""}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Matteson', 'Affiliation': 'US Air Force, Head Quarters Air Force, Washington, DC.'}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Simonson', 'Affiliation': 'US Air Force, Head Quarters Air Force, Washington, DC.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Pflanz', 'Affiliation': ""US Air Force Surgeon General's Office, Falls Church, Virginia.""}]",JAMA network open,['10.1001/jamanetworkopen.2020.22532']
1858,33085033,"Pharmacokinetics and Pharmacodynamics of JNJ-55920839, an Antibody Targeting Interferon α/ω, in Healthy Subjects and Subjects with Mild-to-Moderate Systemic Lupus Erythematosus.","BACKGROUND


The interferon (IFN) pathway has been correlated with clinical and serological markers of disease activity in patients with systemic lupus erythematosus (SLE).
OBJECTIVE


The pharmacokinetics and pharmacodynamics of JNJ-55920839, a fully human immunoglobulin G1κ antibody targeting IFNα/ω, were investigated.
METHODS


In a double-blind, first-in-human study, Part A enrolled 48 healthy adults who received a single dose of placebo/JNJ-55920839 between 0.3 and 15 mg/kg intravenous (IV) or at 1 mg/kg subcutaneous (SC). Part B enrolled 26 adults with SLE who received placebo or JNJ-55920839 10 mg/kg IV 6 times biweekly. Pharmacokinetic parameters were calculated by noncompartmental analysis (NCA) and estimated by nonlinear mixed-effects modeling.
RESULTS


JNJ-55920839 pharmacokinetics following a single IV infusion exhibited a biphasic disposition in healthy subjects. Maximum plasma concentration (C max ) and area under the concentration-time curve values increased dose-proportionally. Mean clearance (CL) after a single IV infusion ranged between 2.28 and 3.09 mL/kg/day. Absolute bioavailability after a single SC injection was ≥ 80.0%. Mean terminal elimination half-life (t 1/2 ) was similar after IV (20.7 to 24.6 days) and SC administration (22.6 days). Steady state of JNJ-55920839 was achieved 6 weeks after multiple 10 mg/kg IV doses in subjects with SLE. Mean steady-state CL and t 1/2  were 4.73 mL/kg/day and 14.8 days, respectively. A linear 2-compartment population pharmacokinetic model with 1st-order absorption and elimination adequately characterized the pharmacokinetics; parameters were consistent with NCA estimates. Higher CL was estimated in subjects with SLE compared with healthy subjects, after correcting for body weight. A trend of increased total IFNα/ω levels was observed after treatment with JNJ-55920839.
CONCLUSION


Pharmacokinetic and pharmacodynamic analyses of the data from this study demonstrated that there was biphasic disposition in both healthy subjects and subjects with SLE, CL was faster in subjects with SLE, and increases in total IFNα/ω levels were observed in both healthy subjects and subjects with SLE after treatment with JNJ-55920839, thus further development is supported. The study is registered at ClinicalTrials.gov NCT02609789.",2020,Maximum plasma concentration (C max ) and area under the concentration-time curve values increased dose-proportionally.,"['patients with systemic lupus erythematosus (SLE', 'Part\xa0B enrolled 26\xa0adults with SLE who received', 'healthy subjects', 'Healthy Subjects and Subjects with Mild-to-Moderate Systemic Lupus Erythematosus', '48 healthy adults who received a single dose of']","['placebo or JNJ-55920839', 'placebo/JNJ-55920839 between 0.3 and 15\xa0mg/kg intravenous (IV) or at 1\xa0mg/kg subcutaneous\xa0(SC']","['Maximum plasma concentration (C max ) and area under the concentration-time curve values', 'Mean steady-state CL', 'biphasic disposition', 'Pharmacokinetic parameters', 'Higher CL', 'total IFNα/ω levels', 'Mean terminal elimination half-life', 'Mean clearance (CL', 'Absolute bioavailability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024141', 'cui_str': 'Systemic lupus erythematosus'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4068885', 'cui_str': '0.3'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0205184', 'cui_str': 'Biphasic'}, {'cui': 'C0184758', 'cui_str': 'Patient disposition'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0018517', 'cui_str': 'Halflife'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}]",48.0,0.142169,Maximum plasma concentration (C max ) and area under the concentration-time curve values increased dose-proportionally.,"[{'ForeName': 'Zhenling', 'Initials': 'Z', 'LastName': 'Yao', 'Affiliation': 'Janssen Research and Development, LLC, Clin Pharm TA PA, SH32-10590, Welsh & McKean Road, Spring House, PA, 19477, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Loggia', 'Affiliation': 'Janssen Research and Development, LLC, Clin Pharm TA PA, SH32-10590, Welsh & McKean Road, Spring House, PA, 19477, USA.'}, {'ForeName': 'Damien', 'Initials': 'D', 'LastName': 'Fink', 'Affiliation': 'Janssen Research and Development, LLC, Clin Pharm TA PA, SH32-10590, Welsh & McKean Road, Spring House, PA, 19477, USA.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Chevrier', 'Affiliation': 'Janssen Research and Development, LLC, Clin Pharm TA PA, SH32-10590, Welsh & McKean Road, Spring House, PA, 19477, USA.'}, {'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Marciniak', 'Affiliation': 'Janssen Research and Development, LLC, Clin Pharm TA PA, SH32-10590, Welsh & McKean Road, Spring House, PA, 19477, USA.'}, {'ForeName': 'Amarnath', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'Janssen Research and Development, LLC, Clin Pharm TA PA, SH32-10590, Welsh & McKean Road, Spring House, PA, 19477, USA.'}, {'ForeName': 'Zhenhua', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'Janssen Research and Development, LLC, Clin Pharm TA PA, SH32-10590, Welsh & McKean Road, Spring House, PA, 19477, USA. ZXu5@its.jnj.com.'}]",Clinical drug investigation,['10.1007/s40261-020-00978-4']
1859,33085056,"Role of GLP-1 Receptor Agonists in Pediatric Obesity: Benefits, Risks, and Approaches to Patient Selection.","PURPOSE OF REVIEW


Effective treatments for pediatric obesity are limited. Glucagon-like peptide-1 receptor (GLP-1R) agonists have emerged as therapeutic agents for obesity in adults and have shown benefits outside of weight loss. Here we explore the evidence for GLP-1R agonist use in pediatric obesity.
RECENT FINDINGS


Emerging evidence suggests that GLP-1R agonists have a role in pediatric obesity treatment. A recently published, randomized, placebo-controlled trial found a greater reduction in BMI z-score (- 0.22 SDs) in adolescents receiving liraglutide compared with placebo. As in adults, gastrointestinal adverse effects were commonly seen. GLP-1R agonists appear to perform favorably compared with other approved pharmacological agents for pediatric obesity. However, heterogeneity in weight loss response, cost, side effects, and need for injections may limit their use in many pediatric patients. Rather than broadly applying this therapy if it is approved, we suggest careful patient selection and monitoring by clinicians pending further studies.",2020,Glucagon-like peptide-1 receptor (GLP-1R) agonists have emerged as therapeutic agents for obesity in adults and have shown benefits outside of weight loss.,"['adolescents receiving', 'Pediatric Obesity']","['liraglutide', 'placebo', 'GLP-1 Receptor Agonists', 'Glucagon-like peptide-1 receptor (GLP-1R) agonists']","['BMI z-score', 'weight loss response, cost, side effects', 'gastrointestinal adverse effects']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C2362324', 'cui_str': 'Childhood obesity'}]","[{'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}, {'cui': 'C0378073', 'cui_str': 'GLP-1R Receptor'}, {'cui': 'C0243192', 'cui_str': 'agonists'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",,0.059442,Glucagon-like peptide-1 receptor (GLP-1R) agonists have emerged as therapeutic agents for obesity in adults and have shown benefits outside of weight loss.,"[{'ForeName': 'Laura C', 'Initials': 'LC', 'LastName': 'Page', 'Affiliation': 'Division of Pediatric Endocrinology and Diabetes, Duke University Medical Center, 3000 Erwin Road, Suite 200, Durham, NC, 27705, USA. laura.page@duke.edu.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Freemark', 'Affiliation': 'Division of Pediatric Endocrinology and Diabetes, Duke University Medical Center, 3000 Erwin Road, Suite 200, Durham, NC, 27705, USA.'}]",Current obesity reports,['10.1007/s13679-020-00409-7']
1860,33085058,"Safety and efficacy of S-1 plus oxaliplatin 130 mg/m 2  combination therapy in patients with previously untreated HER2-negative unresectable, advanced, or recurrent gastric/gastroesophageal junction cancer: a phase II trial (KSCC1501A).","BACKGROUND


In a randomized pivotal global phase III study, S-1 and oxaliplatin 100 mg/m 2  (SOX100) combination chemotherapy was as effective as S-1 and cisplatin for advanced gastric cancer (AGC) and showed a favorable safety profile. In this phase II study, we analyzed survival outcomes to assess the efficacy and safety of the SOX regimen with oxaliplatin 130 mg/m 2  (SOX130) in AGC.
METHODS


Patients with HER2-negative AGC received 80 mg/m 2 /day S-1 orally on days 1-14 and 130 mg/m 2  oxaliplatin intravenously on day 1 of each 21-day cycle until the criteria for treatment withdrawal were fulfilled. The primary endpoint was the response rate (RR), and the null hypothesis of RR in the current trial was 45%. The secondary endpoints were progression-free survival (PFS) and overall survival (OS). Adverse events (AEs) were recorded according to CTCAE version 4.0.
RESULTS


Seventy-one patients were enrolled from June 2015 to November 2016, but eight were excluded for ineligibility. Therefore, all final analyses were conducted with 63 patients. The confirmed RR was 46.0% (90% confidence interval [CI]: 36.1-56.3), and the disease control rate was 77.8% (90% CI: 68.1-85.1). The median PFS and OS were 4.9 (95% CI: 4.2-7.1) and 14.8 (95% CI: 11.1-18.9) months, respectively. Incidences of grade 3-4 AEs > 10% were anorexia (19.0%), peripheral neuropathy (12.7%), nausea (11.1%), and thrombocytopenia (11.1%).
CONCLUSIONS


This study represents the first evaluation of SOX130 in patients with HER2-negative AGC. SOX130 showed an acceptable safety profile, but the prespecified statistical efficacy targets were not achieved.",2020,"Incidences of grade 3-4 AEs > 10% were anorexia (19.0%), peripheral neuropathy (12.7%), nausea (11.1%), and thrombocytopenia (11.1%).
","['Seventy-one patients were enrolled from June 2015 to November 2016, but eight were excluded for ineligibility', 'patients with HER2-negative AGC', 'patients with previously untreated HER2-negative unresectable, advanced, or recurrent gastric/gastroesophageal junction cancer', 'Patients with', '63 patients', 'advanced gastric cancer (AGC']","['HER2-negative AGC received 80\xa0mg/m 2 /day S-1 orally on days 1-14 and 130\xa0mg/m 2  oxaliplatin', 'SOX130', 'S-1 and oxaliplatin 100\xa0mg/m 2  (SOX100) combination chemotherapy', 'S-1 and cisplatin', 'S-1 plus oxaliplatin 130', 'oxaliplatin 130']","['disease control rate', 'anorexia', 'median PFS and OS', 'Safety and efficacy', 'efficacy and safety', 'progression-free survival (PFS) and overall survival (OS', 'thrombocytopenia', 'Adverse events (AEs', 'nausea', 'response rate (RR), and the null hypothesis of RR', 'peripheral neuropathy']","[{'cui': 'C0450389', 'cui_str': '71'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C4087376', 'cui_str': 'HER2 negative'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0014871', 'cui_str': 'Cardioesophageal junction structure'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}]","[{'cui': 'C4087376', 'cui_str': 'HER2 negative'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0879262', 'cui_str': 'S 1 (combination)'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C4081033', 'cui_str': 'oxaliplatin 100 MG'}, {'cui': 'C0013218', 'cui_str': 'Combination Drug Therapy'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003123', 'cui_str': 'Anorexia'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0456148', 'cui_str': 'Null'}, {'cui': 'C1869037', 'cui_str': 'Peripheral neuropathy (SMQ)'}]",71.0,0.258397,"Incidences of grade 3-4 AEs > 10% were anorexia (19.0%), peripheral neuropathy (12.7%), nausea (11.1%), and thrombocytopenia (11.1%).
","[{'ForeName': 'Tomomi', 'Initials': 'T', 'LastName': 'Kashiwada', 'Affiliation': 'Division Hematology, Respiratory Medical and Oncology, Department of Medical Oncology, Saga University, 5-1-1 Nabeshima, Saga, 849-8501, Japan.'}, {'ForeName': 'Katsunori', 'Initials': 'K', 'LastName': 'Shinozaki', 'Affiliation': 'Division of Clinical Oncology, Hirosima Prefectural Hospital, Hirosima, Japan.'}, {'ForeName': 'Shohei', 'Initials': 'S', 'LastName': 'Ueno', 'Affiliation': 'Department of Hematology/Oncology, Japan Community Healthcare Organization Kyushu Hospital, Kitakyushu, Japan.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Kawanaka', 'Affiliation': 'Clinical Research Institute and Department of Surgery, National Hospital Organization, Beppu Medical Center, Beppu, Japan.'}, {'ForeName': 'Futoshi', 'Initials': 'F', 'LastName': 'Uno', 'Affiliation': 'Department of Surgery, Okayama Rosai Hospital, Okayama, Japan.'}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Okita', 'Affiliation': 'Kagawa University Hospital Cancer Center, Takamatsu, Japan.'}, {'ForeName': 'Masaru', 'Initials': 'M', 'LastName': 'Fukahori', 'Affiliation': 'Multidisciplinary Treatment Cancer Center, Kurume University Hospital, Kurume, Japan.'}, {'ForeName': 'Hidenobu', 'Initials': 'H', 'LastName': 'Matsushita', 'Affiliation': 'Department of Surgery, Tosei General Hospital, Seto, Japan.'}, {'ForeName': 'Yasunori', 'Initials': 'Y', 'LastName': 'Emi', 'Affiliation': 'Department of Surgery, Saiseikai Fukuoka General Hospital, Fukuoka, Japan.'}, {'ForeName': 'Mototsugu', 'Initials': 'M', 'LastName': 'Shimokawa', 'Affiliation': 'Department of Biostatistics, Cancer Biostatistics Laboratory, Yamaguchi University Graduate School of Medicine, Clinical Research Institute, Yamaguchi, Japan.'}, {'ForeName': 'Akitaka', 'Initials': 'A', 'LastName': 'Makiyama', 'Affiliation': 'Department of Hematology/Oncology, Japan Community Healthcare Organization Kyushu Hospital, Kitakyushu, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Saeki', 'Affiliation': 'Department of General Surgical Science, Graduate School of Medicine, Gunma University, Maebashi, Japan.'}, {'ForeName': 'Eiji', 'Initials': 'E', 'LastName': 'Oki', 'Affiliation': 'Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan. okieiji@surg2.med.kyushu-u.ac.jp.'}, {'ForeName': 'Yoshihiko', 'Initials': 'Y', 'LastName': 'Maehara', 'Affiliation': 'Department of Surgery, Kyushu Central Hospital of the Mutual Aid Association of PublicSchool Teachers, Fukuoka, Japan.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Mori', 'Affiliation': 'Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan.'}, {'ForeName': 'Eishi', 'Initials': 'E', 'LastName': 'Baba', 'Affiliation': 'Department of Oncology and Social Medicine, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",International journal of clinical oncology,['10.1007/s10147-020-01803-w']
1861,33085088,Minimally invasive parathyroidectomy guided by intraoperative parathyroid hormone monitoring (IOPTH) and preoperative imaging versus bilateral neck exploration for primary hyperparathyroidism in adults.,"BACKGROUND


Bilateral neck exploration (BNE) is the traditional approach to sporadic primary hyperparathyroidism. With the availability of the preoperative imaging techniques and intraoperative parathyroid hormone assays, minimally invasive parathyroidectomy (MIP) is fast becoming the favoured surgical approach.
OBJECTIVES


To assess the effects of minimally invasive parathyroidectomy (MIP) guided by preoperative imaging and intraoperative parathyroid hormone monitoring versus bilateral neck exploration (BNE) for the surgical management of primary hyperparathyroidism.
SEARCH METHODS


We searched CENTRAL, MEDLINE, WHO ICTRP and ClinicalTrials.gov. The date of the last search of all databases was 21 October 2019. There were no language restrictions applied.
SELECTION CRITERIA


We included randomised controlled trials comparing MIP to BNE for the treatment of sporadic primary hyperparathyroidism in persons undergoing surgery for the first time.
DATA COLLECTION AND ANALYSIS


Two review authors independently screened titles and abstracts for relevance. Two review authors independently screened for inclusion, extracted data and carried out risk of bias assessment. The content expert senior author resolved conflicts. We assessed studies for overall certainty of the evidence using the GRADE instrument. We conducted meta-analyses using a random-effects model and performed statistical analyses according to the guidelines in the latest version of the Cochrane Handbook for Systematic Reviews of Interventions.
MAIN RESULTS


We identified five eligible studies, all conducted in European university hospitals. They included 266 adults, 136 participants were randomised to MIP and 130 participants to BNE. Data were available for all participants post-surgery up to one year, with the exception of missing data for two participants in the MIP group and for one participant in the BNE group at one year. Nine participants in the MIP group and 11 participants in the BNE group had missing data at five years. No study had a low risk of bias in all risk of bias domains. The risk ratio (RR) for success rate (eucalcaemia) at six months in the MIP group compared to the BNE group was 0.98 (95% confidence interval (CI) 0.94 to 1.03; P = 0.43; 5 studies, 266 participants; very low-certainty evidence). A total of 132/136 (97.1%) participants in the MIP group compared with 129/130 (99.2%) participants in the BNE group were judged as operative success. At five years, the RR was 0.94 (95% CI 0.83 to 1.08; P = 0.38; 1 study, 77 participants; very low-certainty evidence). A total of 34/38 (89.5%) participants in the MIP group compared with 37/39 (94.9%) participants in the BNE group were judged as operative success. The RR for the total incidence of perioperative adverse events was 0.50, in favour of MIP (95% CI 0.33 to 0.76; P = 0.001; 5 studies, 236 participants; low-certainty evidence). Perioperative adverse events occurred in 23/136 (16.9%) participants in the MIP group compared with 44/130 (33.9%) participants in the BNE group. The 95% prediction interval ranged between 0.25 and 0.99. These adverse events included symptomatic hypocalcaemia, vocal cord palsy, bleeding, fever and infection. Fifteen of 104 (14.4%) participants experienced symptomatic hypocalcaemia in the MIP group compared with 26/98 (26.5%) participants in the BNE group. The RR for this event comparing MIP with BNE at two days was 0.54 (95% CI 0.32 to 0.92; P = 0.02; 4 studies, 202 participants). Statistical significance was lost in sensitivity analyses, with a 95% prediction interval ranging between 0.17 and 1.74. Five out of 133 (3.8%) participants in the MIP group experienced vocal cord paralysis compared with 2/128 (1.6%) participants in the BNE group. The RR for this event was 1.87 (95% CI 0.47 to 7.51; P = 0.38; 5 studies, 261 participants). The 95% prediction interval ranged between 0.20 and 17.87. The effect on all-cause mortality was not explicitly reported and could not be adequately assessed (very low-certainty evidence). There was no clear difference for health-related quality of life between the treatment groups in two studies, but studies did not report numerical data (very low-certainty evidence). There was a possible treatment benefit for MIP compared to BNE in terms of cosmetic satisfaction (very low-certainty evidence). The mean difference (MD) for duration of surgery comparing BNE with MIP was in favour of the MIP group (-18 minutes, 95% CI -31 to -6; P = 0.004; 3 studies, 171 participants; very low-certainty evidence). The 95% prediction interval ranged between -162 minutes and 126 minutes. The studies did not report length of hospital stay. Four studies reported intraoperative conversion rate from MIP to open procedure information. Out of 115 included participants, there were 24 incidences of conversion, amounting to a conversion rate of 20.8%.
AUTHORS' CONCLUSIONS


The success rates of MIP and BNE at six months were comparable. There were similar results at five years, but these were only based on one study. The incidence of perioperative symptomatic hypocalcaemia was lower in the MIP compared to the BNE group, whereas the incidence of vocal cord paralysis tended to be higher. Our systematic review did not provide clear evidence for the superiority of MIP over BNE. However, it was limited by low-certainty to very low-certainty evidence.",2020,There was a possible treatment benefit for MIP compared to BNE in terms of cosmetic satisfaction (very low-certainty evidence).,"['Nine participants in the MIP group and 11 participants in the BNE group had missing data at five years', 'They included 266 adults, 136 participants were randomised to MIP and 130 participants to BNE', 'primary hyperparathyroidism in adults', 'persons undergoing surgery for the first time']","['MIP to BNE', 'Minimally invasive parathyroidectomy guided by intraoperative parathyroid hormone monitoring (IOPTH) and preoperative imaging versus bilateral neck exploration', 'Bilateral neck exploration (BNE', 'minimally invasive parathyroidectomy (MIP) guided by preoperative imaging and intraoperative parathyroid hormone monitoring versus bilateral neck exploration (BNE']","['total incidence of perioperative adverse events', 'vocal cord paralysis', 'operative success', 'risk ratio (RR) for success rate (eucalcaemia', 'health-related quality of life', 'cosmetic satisfaction', 'success rates of MIP and BNE', 'symptomatic hypocalcaemia', 'Perioperative adverse events', 'symptomatic hypocalcaemia, vocal cord palsy, bleeding, fever and infection', 'perioperative symptomatic hypocalcaemia']","[{'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0079989', 'cui_str': 'Parathyroidectomy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C1096695', 'cui_str': 'Neck exploration'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0221002', 'cui_str': 'Primary hyperparathyroidism'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0079989', 'cui_str': 'Parathyroidectomy'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C1096695', 'cui_str': 'Neck exploration'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0020063', 'cui_str': 'PTH protein, human'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0042928', 'cui_str': 'Vocal cord paralysis'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0010164', 'cui_str': 'Cosmetic'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0079989', 'cui_str': 'Parathyroidectomy'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C1096695', 'cui_str': 'Neck exploration'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0020598', 'cui_str': 'Hypocalcemia'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]",136.0,0.208146,There was a possible treatment benefit for MIP compared to BNE in terms of cosmetic satisfaction (very low-certainty evidence).,"[{'ForeName': 'Hala', 'Initials': 'H', 'LastName': 'Ahmadieh', 'Affiliation': 'Department of Internal Medicine, Beirut Arab University, Beirut, Lebanon.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Kreidieh', 'Affiliation': ""Department of Medicine, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston MA, Massachusetts, USA.""}, {'ForeName': 'Elie A', 'Initials': 'EA', 'LastName': 'Akl', 'Affiliation': 'Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon.'}, {'ForeName': 'Ghada', 'Initials': 'G', 'LastName': 'El-Hajj Fuleihan', 'Affiliation': 'Department of Internal Medicine, Calcium Metabolism and Osteoporosis Program, WHO Collaborating Center for Metabolic Bone Disorders, Division of Endocrinology, American University of Beirut Medical Centre, Beirut, Lebanon.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD010787.pub2']
1862,33085237,[Clinical effects of scaling and root planing with an adjunctive periodontal endoscope for residual pockets: a randomized controlled clinical study].,"OBJECTIVE


To evaluate the efficacy of scaling and root planing (SRP) with a periodontal endoscope in the treatment of residual pockets in patients with periodontitis after initial periodontal therapy.
METHODS


Patients with residual pockets [probing depth (PD)≥5 mm] were included and randomly assigned to the endoscope group (SRP with a periodontal endoscope) or SRP group (SRP alone). The PD, attachment loss (AL), and bleeding on probing (BOP) of residual pockets were recorded before treatment and at 3 and 6 months after treatment. Data were analyzed with SPSS 20.0 software.
RESULTS


Compared with the baseline values, the percentage of PD≥5 mm sites, PD, AL, and BOP (+)% in the endoscope group and SRP group at 3 and 6 months after treatment decreased (P<0.05). Compared with the values at 3 months after treatment, the percentage of PD≥5 mm sites, PD, AL, and BOP (+)% at 3 and 6 months after treatment decreased in the endoscope group (P<0.05), whereas no statistical difference in these values was observed in the SRP group (P>0.05). Compared with those in the SRP group, the percentage of PD≥5 mm sites and PD at 3 and 6 months after treatment and AL and BOP (+)% at 6 months after treatment in the endoscope group decreased (P<0.05).
CONCLUSIONS


SRP with a periodontal endoscope shows a better effect in improving the PD, AL, and BOP of residual pockets (PD≥5 mm) in patients with periodontitis after initial periodontal therapy and has advantages in improving the long-term curative effect of this therapy.",2020,"The PD, attachment loss (AL), and bleeding on probing (BOP) of residual pockets were recorded before treatment and at 3 and 6 months after treatment.","['residual pockets', 'patients with periodontitis', 'patients with periodontitis after initial periodontal therapy', 'Patients with residual pockets [probing depth (PD)≥5 mm']","['scaling and root planing', 'periodontal endoscope', 'endoscope group (SRP with a periodontal endoscope) or SRP group (SRP alone', 'scaling and root planing (SRP', 'adjunctive periodontal endoscope']","['PD, attachment loss (AL), and bleeding on probing (BOP) of residual pockets', 'percentage of PD≥5 mm sites and PD', 'percentage of PD≥5 mm sites, PD, AL, and BOP ']","[{'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}]","[{'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0085287', 'cui_str': 'Root planing of tooth'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0014243', 'cui_str': 'Endoscope'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}]","[{'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0205145', 'cui_str': 'Site'}]",,0.0303457,"The PD, attachment loss (AL), and bleeding on probing (BOP) of residual pockets were recorded before treatment and at 3 and 6 months after treatment.","[{'ForeName': 'Yang-Heng', 'Initials': 'YH', 'LastName': 'Zhang', 'Affiliation': 'Dept. of Periodontology, Nanjing Stomatological Hospital, Medical School of Nanjing University, Nanjing 210008, China.'}, {'ForeName': 'Hou-Xuan', 'Initials': 'HX', 'LastName': 'Li', 'Affiliation': 'Dept. of Periodontology, Nanjing Stomatological Hospital, Medical School of Nanjing University, Nanjing 210008, China.'}, {'ForeName': 'Fu-Hua', 'Initials': 'FH', 'LastName': 'Yan', 'Affiliation': 'Dept. of Periodontology, Nanjing Stomatological Hospital, Medical School of Nanjing University, Nanjing 210008, China.'}, {'ForeName': 'Bao-Chun', 'Initials': 'BC', 'LastName': 'Tan', 'Affiliation': 'Dept. of Periodontology, Nanjing Stomatological Hospital, Medical School of Nanjing University, Nanjing 210008, China.'}]",Hua xi kou qiang yi xue za zhi = Huaxi kouqiang yixue zazhi = West China journal of stomatology,['10.7518/hxkq.2020.05.010']
1863,33079611,Integrated telehealth-assisted home-based specialist palliative care in rural Australia: A feasibility study.,"INTRODUCTION


This study assessed the feasibility of integrating telehealth-assisted home-based specialist palliative care (TH-SPC) into a rural community setting.
METHODS


This was a prospective mixed-methods pilot study conducted in rural Victoria, Australia. Newly engaged adult patients and their caregivers of a community palliative-care service received video consultations with metropolitan-located specialist palliative-care physicians, alongside standard care. Those eligible patients who failed to receive TH-SPC were treated as a control group upon analysis. Data were collected over three months and at 30 days prior to death. Feasibility outcomes included efficiency of process, user satisfaction, clinical outcome and health-care metrics.
RESULTS


A total of 21 patients completed the study, with an average age of 70.4 years and an average survival of 5.8 months. Fourteen patients received TH-SPC, and seven received standard care alone. Patient-caregiver feedback for TH-SPC showed a high level of overall satisfaction. Compared to standard care, the TH-SPC group demonstrated less functional decline from baseline at two weeks (Australia-modified Karnofsky Performance Status: -1.35 vs. -12.30,  p  = 0.067) and three months (8.48 vs. -10.79,  p  = 0.04) after the intervention. At 30 days prior to death, functional status remained better in the TH-SPC group, with fewer per capita community palliative-care nursing visits (5.46 vs. 9.32, effect size = 0.7), general practitioner visits (0.13 vs. 3.88, effect size = 1.34) and hospital admissions (0.02 vs. 0.2, effect size = 0.65).
DISCUSSION


TH-SPC was successfully integrated into rural community-based palliative care, with potential benefits in performance status preservation and health-care resource utilisation.",2020,"This study assessed the feasibility of integrating telehealth-assisted home-based specialist palliative care (TH-SPC) into a rural community setting.
","['Newly engaged adult patients and their caregivers of a community palliative-care service received', 'rural Victoria, Australia', '21 patients completed the study, with an average age of 70.4 years and an average survival of 5.8 months', 'rural Australia']","['TH-SPC', 'Integrated telehealth-assisted home-based specialist palliative care', 'standard care alone', 'integrating telehealth-assisted home-based specialist palliative care (TH-SPC', 'video consultations with metropolitan-located specialist palliative-care physicians, alongside standard care']","['general practitioner visits', 'efficiency of process, user satisfaction, clinical outcome and health-care metrics', 'functional decline', 'hospital admissions']","[{'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0587605', 'cui_str': 'Palliative care service'}, {'cui': 'C0042645', 'cui_str': 'Victoria'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C4517796', 'cui_str': '5.8'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1273400', 'cui_str': 'Specialist palliative care'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0031831', 'cui_str': 'Physician'}]","[{'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]",21.0,0.071387,"This study assessed the feasibility of integrating telehealth-assisted home-based specialist palliative care (TH-SPC) into a rural community setting.
","[{'ForeName': 'Beisi', 'Initials': 'B', 'LastName': 'Jiang', 'Affiliation': 'Monash Medical Centre, Faculty of Medicine, Nursing and Health Science, Monash University, Australia.'}, {'ForeName': 'Maryann', 'Initials': 'M', 'LastName': 'Bills', 'Affiliation': 'Supportive and Palliative Care Unit, Monash Health, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Poon', 'Affiliation': 'Monash Medical Centre, Faculty of Medicine, Nursing and Health Science, Monash University, Australia.'}]",Journal of telemedicine and telecare,['10.1177/1357633X20966466']
1864,33079705,"Individualized homeopathic medicines and Urtica urens mother tincture in treatment of hyperuricemia: an open, randomized, pragmatic, pilot trial.","Objectives The quality of management of hyperuricemia has remained sub-optimal owing to unavoidable toxicities, limitations, and dearth of novel advances. Homeopathy has remained under-researched in hyperuricemia. We investigated the clinical effectiveness of three treatment regimens - individualized homeopathy (IH), Urtica urens mother tincture (UUMT), and both (IH + UUMT) along with lifestyle modifications in a sample of 90 patients with hyperuricemia. Methods An open, randomized (1:1:1), 3 parallel arms (IH, UUMT, and IH + UUMT), pragmatic trial was conducted at National Institute of Homoeopathy, Kolkata. Outcome measures were serum uric acid (primary), Gout Assessment Questionnaire version 2 (GAQ2, secondary), and Measure Yourself Medical Outcome Profile version 2 (MYMOP2, secondary); all measured at baseline, and after 3 and 6 months. Intention- to-treat sample was analyzed to detect group differences by unpaired t tests. Results Attrition rate was 8.9% (IH: 3, UUMT: 3, IH + UUMT: 2). Groups were comparable at baseline. Reductions in serum uric acid over 3 months were comparatively higher (p=0.057) in the UUMT group than others, however, the differences were narrowed over 6 months (p=0.119). Per protocol analysis of serum uric acid level revealed similar trend of significantly higher reduction in the UUMT group than the other two (3 months: p=0.001; 6 months: p=0.007). No significant differences existed in reductions of GAQ2 scores among the three groups. Few significant differences were detected in MYMOP scores over 3 months favoring IH against others (symptom 2, p=0.001 and wellbeing score, p=0.002), and also over 6 months favoring IH + UUMT against others (symptom 1, p<0.001). Conclusion Although all three therapies showed similar improvements, the IH + UUMT group had more positive direction of effects than IH or UUMT alone; however, no definite conclusion could be arrived at. Further trials are warranted with larger sample size. Trial registration: CTRI/2018/05/014026.",2020,"Reductions in serum uric acid over 3 months were comparatively higher (p=0.057) in the UUMT group than others, however, the differences were narrowed over 6 months (p=0.119).","['hyperuricemia', '90 patients with hyperuricemia']","['UUMT', 'Individualized homeopathic medicines and Urtica urens mother tincture', ' individualized homeopathy (IH), Urtica urens mother tincture (UUMT), and both (IH\xa0+\xa0UUMT', 'IH\xa0+\xa0UUMT']","['serum uric acid (primary), Gout Assessment Questionnaire version 2 (GAQ2, secondary), and Measure Yourself Medical Outcome Profile version 2 (MYMOP2, secondary', 'Attrition rate', 'serum uric acid', 'GAQ2 scores', 'MYMOP scores', 'serum uric acid level']","[{'cui': 'C0740394', 'cui_str': 'Hyperuricemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0684199', 'cui_str': 'Homeopathic therapy'}, {'cui': 'C0330546', 'cui_str': 'Genus Urtica'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0991583', 'cui_str': 'Tincture'}]","[{'cui': 'C0455272', 'cui_str': 'Serum urate measurement'}, {'cui': 'C0018099', 'cui_str': 'Gout'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",90.0,0.0944028,"Reductions in serum uric acid over 3 months were comparatively higher (p=0.057) in the UUMT group than others, however, the differences were narrowed over 6 months (p=0.119).","[{'ForeName': 'Chintamani', 'Initials': 'C', 'LastName': 'Nayak', 'Affiliation': 'Shree Guru Gobind Singh Tricentenary University, Gurgaon, Gurugram, Haryana 122505, India.'}, {'ForeName': 'Nivedita', 'Initials': 'N', 'LastName': 'Pattanaik', 'Affiliation': 'Dept. of Materia Medica, Rajasthan Vidyapeeth Homoeopathic Medical College and Hospital, Udaipur, Rajasthan, India.'}, {'ForeName': 'Abhijit', 'Initials': 'A', 'LastName': 'Chattopadhyay', 'Affiliation': 'Dept. of Materia Medica, National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India, Block GE, Sector 3, Salt Lake, Kolkata 700106, West Bengal, India.'}, {'ForeName': 'Pankhuri', 'Initials': 'P', 'LastName': 'Misra', 'Affiliation': 'Dept. of Materia Medica, National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India, Block GE, Sector 3, Salt Lake, Kolkata 700106, West Bengal, India.'}, {'ForeName': 'Koushik', 'Initials': 'K', 'LastName': 'Bhar', 'Affiliation': 'Dept. of Materia Medica, National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India, Block GE, Sector 3, Salt Lake, Kolkata 700106, West Bengal, India.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Michael', 'Affiliation': 'Dept. of Organon of Medicine and Homoeopathic Philosophy, National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India, Kolkata, West Bengal, India.'}, {'ForeName': 'Munmun', 'Initials': 'M', 'LastName': 'Koley', 'Affiliation': 'Champsara, West Bengal, India.'}, {'ForeName': 'Subhranil', 'Initials': 'S', 'LastName': 'Saha', 'Affiliation': 'Howrah, West Bengal, India.'}]",Journal of complementary & integrative medicine,['10.1515/jcim-2020-0129']
1865,33086286,Trauma-focused cognitive behavioural therapy and exercise for chronic whiplash with comorbid posttraumatic stress disorder: a randomised controlled trial.,"Many people with chronic whiplash associated disorders (WAD) also have symptoms of posttraumatic stress disorder (PTSD), but this is rarely considered in usual predominantly exercise based interventions. We aimed to investigate the effectiveness of combined trauma focused cognitive behavioural therapy (TF-CBT) and exercise compared to supportive therapy (ST) and exercise for people with chronic WAD and PTSD. A randomised controlled multi-centre trial with concealed allocation, assessor blinding, and blinded analysis was conducted. 103 participants with chronic WAD (>3 months and <5 years, grade II) and PTSD were randomised to TF-CBT and exercise (n=53) or ST and exercise (n=50). Both interventions comprised 10 weeks of TF-CBT or ST followed by 6 weeks of exercise. Outcomes were measured at baseline, 10 weeks, 16 weeks, 6 months, and 12 months post-randomisation. Analysis was intention to treat using linear mixed models. There was no difference between the interventions on the primary outcome of neck pain related disability at any time point. At 16 weeks, the treatment effect on the 0-100 Neck Disability Index was 0.59 (95% CI 5.51 to -4.33), at 6 months 1.18 (6.15 to -3.78), and at 12 months 1.85 (6.81 to -3.11). In addition, there was no difference between the interventions for the majority of secondary outcomes at any time. Exceptions were in favour of TF-CBT and exercise, where improvements in PTSD symptoms were found at 16 weeks. From 16 weeks onwards, both groups achieved a clinically important improvement in neck pain related disability. However, both groups remained moderately disabled.",2020,"At 16 weeks, the treatment effect on the 0-100 Neck Disability Index was 0.59 (95% CI 5.51 to -4.33), at 6 months 1.18 (6.15 to -3.78), and at 12 months 1.85 (6.81 to -3.11).","['chronic whiplash with comorbid posttraumatic stress disorder', '103 participants with chronic WAD (>3 months and <5 years, grade II) and PTSD', 'Many people with chronic whiplash associated disorders (WAD', 'people with chronic WAD and PTSD']","['TF-CBT and exercise (n=53) or ST and exercise', 'TF-CBT or ST', 'Trauma-focused cognitive behavioural therapy and exercise', 'combined trauma focused cognitive behavioural therapy (TF-CBT) and exercise compared to supportive therapy (ST) and exercise']","['neck pain related disability', 'PTSD symptoms', '0-100 Neck Disability Index']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0043145', 'cui_str': 'Whiplash injury to neck'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C1292726', 'cui_str': 'Associated disorder'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0344211', 'cui_str': 'Support'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",103.0,0.171547,"At 16 weeks, the treatment effect on the 0-100 Neck Disability Index was 0.59 (95% CI 5.51 to -4.33), at 6 months 1.18 (6.15 to -3.78), and at 12 months 1.85 (6.81 to -3.11).","[{'ForeName': 'Tonny Elmose', 'Initials': 'TE', 'LastName': 'Andersen', 'Affiliation': 'Department of Psychology, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Sophie Lykkegaard', 'Initials': 'SL', 'LastName': 'Ravn', 'Affiliation': 'Department of Psychology, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Armfield', 'Affiliation': 'RECOVER Injury Research Centre and NHMRC CRE in Road Traffic Injury Recovery, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Annick', 'Initials': 'A', 'LastName': 'Maujean', 'Affiliation': 'Centre for Applied Health Economics, Menzies Health Institute Queensland, School of Medicine, Griffith University, Australia.'}, {'ForeName': 'Simone Scotti', 'Initials': 'SS', 'LastName': 'Requena', 'Affiliation': 'RECOVER Injury Research Centre and NHMRC CRE in Road Traffic Injury Recovery, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Sterling', 'Affiliation': 'RECOVER Injury Research Centre and NHMRC CRE in Road Traffic Injury Recovery, The University of Queensland, Brisbane, Australia.'}]",Pain,['10.1097/j.pain.0000000000002117']
1866,33086290,Effect of anti-inflammatory regimen on early postoperative inflammation after cataract surgery.,"PURPOSE


To investigate if a combination of topical nonsteroid anti-inflammatory drugs (NSAIDs) and steroids were superior in controlling early postoperative inflammation after cataract surgery compared with topical NSAIDs alone and with dropless surgery where a subtenon depot of steroid was placed during surgery.
SETTING


Department of Ophthalmology, Rigshospitalet-Glostrup, Denmark.
DESIGN


Prospective randomized controlled trial with masked statistical analyses.
METHODS


Patients undergoing phacoemulsification for age-related cataract were randomized to 1 of 5 regimens: ketorolac and prednisolone eyedrops combined (groups Pred+NSAID-Pre [control group] and Pred+NSAID-Post) vs ketorolac monotherapy (groups NSAID-Pre and NSAID-Post) vs subtenon depot of dexamethasone (Dropless group). Drops were used until 3 weeks postoperatively, starting 3 days before surgery in the ""Pre"" groups and on the day of surgery in the ""Post"" groups. Aqueous flare was measured at baseline and 3 days postoperatively.
RESULTS


456 participants, mean age 72.1 (SD 7.0) years, 283 (62%) females, were included. Flare increased significantly more in the Dropless group compared with control (Pred+NSAID-Pre), but none of the other groups differed significantly from the control. Intraocular pressure decreased in all groups but significantly less in groups receiving prednisolone eyedrops (Pred+NSAID-Pre and Pred+NSAID-Post) compared with NSAID monotherapy and Drop-less. No differences in postoperative visual acuity were found compared with control.
CONCLUSIONS


No differences were found between groups randomized to NSAID monotherapy or combination of NSAID and steroid in controlling early inflammation after cataract surgery but subtenon depot of dexamethasone was less efficient. Initiating prophylactic eyedrops prior to surgery did not influence early postoperative anterior chamber inflammation.",2020,No differences were found between groups randomized to NSAID monotherapy or combination of NSAID and steroid in controlling early inflammation after cataract surgery but subtenon depot of dexamethasone was less efficient.,"['Patients undergoing phacoemulsification for age-related cataract', 'early postoperative inflammation after cataract surgery', '456 participants, mean age 72.1 (SD 7.0) years, 283 (62%) females, were included', 'Department of Ophthalmology, Rigshospitalet-Glostrup, Denmark']","['topical NSAIDs alone and with dropless surgery', 'NSAID monotherapy', 'dexamethasone', 'anti-inflammatory regimen', 'NSAID and steroid', 'topical nonsteroid anti-inflammatory drugs (NSAIDs) and steroids', 'prednisolone eyedrops', 'ketorolac and prednisolone eyedrops combined (groups Pred+NSAID-Pre [control group] and Pred+NSAID-Post) vs ketorolac monotherapy (groups NSAID-Pre and NSAID-Post) vs subtenon depot of dexamethasone']","['Aqueous flare', 'postoperative anterior chamber inflammation', 'Intraocular pressure', 'postoperative visual acuity', 'Flare']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0282545', 'cui_str': 'Phacoemulsification'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086543', 'cui_str': 'Cataract'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C1306068', 'cui_str': 'Secondary cataract'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4708786', 'cui_str': '283'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0029087', 'cui_str': 'Ophthalmology'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0015399', 'cui_str': 'Eye drops'}, {'cui': 'C0073631', 'cui_str': 'Ketorolac'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0687676', 'cui_str': 'After values'}]","[{'cui': 'C0423281', 'cui_str': 'Anterior chamber flare'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1096278', 'cui_str': 'Anterior chamber inflammation'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}]",456.0,0.0691359,No differences were found between groups randomized to NSAID monotherapy or combination of NSAID and steroid in controlling early inflammation after cataract surgery but subtenon depot of dexamethasone was less efficient.,"[{'ForeName': 'Jesper H', 'Initials': 'JH', 'LastName': 'Erichsen', 'Affiliation': 'From the Department of Ophthalmology, Rigshospitalet-Glostrup, Glostrup, Denmark (Erichsen, Holm, Kessel); Section of Biostatistics, Department of Public Health, University of Copenhagen, Copenhagen. Denmark (Forman); Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark (Holm, Kessel).'}, {'ForeName': 'Julie L', 'Initials': 'JL', 'LastName': 'Forman', 'Affiliation': ''}, {'ForeName': 'Lars M', 'Initials': 'LM', 'LastName': 'Holm', 'Affiliation': ''}, {'ForeName': 'Line', 'Initials': 'L', 'LastName': 'Kessel', 'Affiliation': ''}]",Journal of cataract and refractive surgery,['10.1097/j.jcrs.0000000000000455']
1867,33086328,"Comment on ""Primary Open Versus Closed Implantation Strategy for Totally Implantable Venous Access Ports. The Multicentre Randomized Controlled PORTAS-3 Trial"".",,2020,,[],['Primary Open Versus Closed Implantation Strategy'],[],[],"[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]",[],,0.089569,,"[{'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Biffi', 'Affiliation': 'Department of Gastrointestinal Surgery, IRCCS European Institute of Oncology, Milan, Italy Department of Surgical Sciences, University of Genova and National Cancer Institute, Genoa, Italy Department of Surgery, Catholic University Hospital, Rome, Italy.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Bertoglio', 'Affiliation': ''}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Pittiruti', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of surgery,['10.1097/SLA.0000000000004409']
1868,33086370,Screen-Based Simulation for Training and Automated Assessment of Teamwork Skills: Comparing 2 Modes With Different Interactivity.,"INTRODUCTION


The need for teamwork training is well documented; however, teaching these skills is challenging given the logistics of assembling individual team members together to train in person. We designed 2 modes of screen-based simulation for training teamwork skills to assess whether interactivity with nonplayer characters was necessary for in-game performance gains or for player satisfaction with the experience.
METHODS


Mixed, randomized, repeated measures study with licensed healthcare providers block-stratified and randomized to evaluation-participant observes and evaluates the team player in 3 scenarios-and game play-participant is immersed as the leader in the same 3 scenarios. Teamwork construct scores (leadership, communication, situation monitoring, mutual support) from an ontology-based, Bayesian network assessment model were analyzed using mixed randomized repeated measures analyses of variance to compare performance, across scenarios and modes. Learning was measured by pretest and posttest quiz scores. User experience was evaluated using χ analyses.
RESULTS


Among 166 recruited and randomized participants, 120 enrolled in the study and 109 had complete data for analysis. Mean composite teamwork Bayesian network scores improved for successive scenarios in both modes, with evaluation scores statistically higher than game play for every teamwork construct and scenario (r = 0.73, P = 0.000). Quiz scores improved from pretest to posttest (P = 0.004), but differences between modes were not significant.
CONCLUSIONS


For training teamwork skills using screen-based simulation, interactivity of the player with the nonplayer characters is not necessary for in-game performance gains or for player satisfaction with the experience.",2020,"Mean composite teamwork Bayesian network scores improved for successive scenarios in both modes, with evaluation scores statistically higher than game play for every teamwork construct and scenario (r = 0.73, P = 0.000).","['Teamwork Skills', '166 recruited and randomized participants, 120 enrolled in the study and 109 had complete data for analysis']",['licensed healthcare providers block-stratified and randomized to evaluation-participant observes and evaluates the team player in 3 scenarios-and game play-participant'],"['Teamwork construct scores (leadership, communication, situation monitoring, mutual support', 'Learning', 'Mean composite teamwork Bayesian network scores', 'Quiz scores']","[{'cui': 'C5191361', 'cui_str': '166'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0032214', 'cui_str': 'Play'}]","[{'cui': 'C0012931', 'cui_str': 'Recombinant DNA'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0023181', 'cui_str': 'Leadership'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}]",166.0,0.0428119,"Mean composite teamwork Bayesian network scores improved for successive scenarios in both modes, with evaluation scores statistically higher than game play for every teamwork construct and scenario (r = 0.73, P = 0.000).","[{'ForeName': 'Randolph H', 'Initials': 'RH', 'LastName': 'Steadman', 'Affiliation': ""From the Department of Anesthesiology and Critical Care (R.H.S.), Houston Methodist Hospital, Houston, TX; Department of Anesthesiology and Perioperative Medicine (Y.M.H.), David Geffen School of Medicine at UCLA; UCLA Simulation Center (Y.M.H.); National Center for Research on Evaluation, Standards, and Student Testing (CRESST) (M.R.I.); CRESST (J.J.L., A.D.K.), Los Angeles, CA; Department of Surgery (A.T.), David Geffen School of Medicine at UCLA; UCLA Center for Advanced Surgical & Interventional Technology Accredited Education Institute (A.T.), Los Angeles; Consultant, (M.D.D.R.) Claremont, CA; UCLA Graduate School of Education and Information Studies (R.L.); David Geffen School of Medicine at UCLA Dean's Office/UCLA Simulation Center (R.K.); UCLA Graduate School of Education and Information Studies (F.R.); Department of Medicine (F.R.), David Geffen School of Medicine at UCLA, Los Angeles, CA; Department of Culture & Communication (S.M.S.), Linköping Universitet, Linköping, Sweden; Department of Surgery (Y.-Y.J.), David Geffen School of Medicine at UCLA, Los Angeles; Community Memorial Health System (C.R.), Ventura; Department of Anesthesiology and Perioperative Medicine (S.P.P.), David Geffen School of Medicine at UCLA; and UCLA Graduate School of Education and Information Studies (N.M.W.), Los Angeles, CA.""}, {'ForeName': 'Yue Ming', 'Initials': 'YM', 'LastName': 'Huang', 'Affiliation': ''}, {'ForeName': 'Markus R', 'Initials': 'MR', 'LastName': 'Iseli', 'Affiliation': ''}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Areti', 'Initials': 'A', 'LastName': 'Tillou', 'Affiliation': ''}, {'ForeName': 'Maria D D', 'Initials': 'MDD', 'LastName': 'Rudolph', 'Affiliation': ''}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Lewin', 'Affiliation': ''}, {'ForeName': 'Alan D', 'Initials': 'AD', 'LastName': 'Koenig', 'Affiliation': ''}, {'ForeName': 'Rukhsana', 'Initials': 'R', 'LastName': 'Khan', 'Affiliation': ''}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Raia', 'Affiliation': ''}, {'ForeName': 'S Michael', 'Initials': 'SM', 'LastName': 'Smith', 'Affiliation': ''}, {'ForeName': 'Yen-Yi', 'Initials': 'YY', 'LastName': 'Juo', 'Affiliation': ''}, {'ForeName': 'Cameron', 'Initials': 'C', 'LastName': 'Rice', 'Affiliation': ''}, {'ForeName': 'Sophia P', 'Initials': 'SP', 'LastName': 'Poorsattar', 'Affiliation': ''}, {'ForeName': 'Noreen M', 'Initials': 'NM', 'LastName': 'Webb', 'Affiliation': ''}]",Simulation in healthcare : journal of the Society for Simulation in Healthcare,['10.1097/SIH.0000000000000510']
1869,33086425,"Randomized, ""head-to-head"" studies comparing different SGLT2 inhibitors are definitely needed.",,2020,,[],[],[],[],[],[],,0.0366493,,"[{'ForeName': 'Kazuomi', 'Initials': 'K', 'LastName': 'Kario', 'Affiliation': 'Jichi Medical University School of Medicine, Tochigi, Japan.'}, {'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Harada', 'Affiliation': 'Jichi Medical University School of Medicine, Tochigi, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Hoshide', 'Affiliation': 'Jichi Medical University School of Medicine, Tochigi, Japan.'}]","Journal of clinical hypertension (Greenwich, Conn.)",['10.1111/jch.14077']
1870,33086435,The therapy with icosapent ethyl after the EVAPORATE trial: Between hope and skepticism.,,2020,,[],[],[],[],[],[],,0.0241034,,"[{'ForeName': 'Marijana', 'Initials': 'M', 'LastName': 'Tadic', 'Affiliation': 'University Hospital ""Dr. Dragisa Misovic - Dedinje"" Department of Cardiology, Belgrade, Serbia.'}, {'ForeName': 'Cesare', 'Initials': 'C', 'LastName': 'Cuspidi', 'Affiliation': 'University of Milan-Bicocca, Milan, Italy.'}]","Journal of clinical hypertension (Greenwich, Conn.)",['10.1111/jch.14082']
1871,33086438,Ustekinumab is effective and safe for ulcerative colitis through 2 years of maintenance therapy.,"BACKGROUND


The ongoing UNIFI long-term extension evaluates subcutaneous ustekinumab for moderate-to-severe ulcerative colitis (UC) from weeks 44 through 220.
AIMS


To assess efficacy (through week 92) and safety (through week 96) during the long-term extension METHODS: Overall, 399 responders to intravenous ustekinumab induction and who were randomised to maintenance therapy were treated in the long-term extension (115 received subcutaneous placebo, 141 received ustekinumab 90 mg every 12 weeks [q12w], and 143 received ustekinumab 90 mg q8w). Placebo treatment was discontinued at unblinding after week 44. Partial Mayo scores were collected every 12 weeks and at each dosing visit after unblinding. Safety was evaluated throughout.
RESULTS


Among all patients randomised in maintenance, symptomatic remission rates (stool frequency = 0/1; rectal bleeding = 0) at week 92 were, 64.5% and 67.6% in the ustekinumab q12w and q8w groups, respectively. Among randomised patients treated in the long-term extension, 78.7% and 83.2% of patients receiving q12w and q8w, respectively, attained symptomatic remission at week 92; >95% of patients in symptomatic remission at week 92 were corticosteroid-free. Both ustekinumab groups maintained efficacy through week 92. From weeks 44 to 96, adverse events (AEs) per hundred patient-years (PY) of follow-up for combined ustekinumab vs placebo were: 255.68 vs 267.93; serious AEs, 9.34 vs 12.69; malignancies (including non-melanoma skin cancers), 0.93 vs 1.49; and serious infections, 2.33 vs 2.99. One patient with multiple comorbidities who received one ustekinumab dose after dose adjusting from placebo experienced a fatal cardiac arrest.
CONCLUSIONS


The efficacy of ustekinumab in patients with UC was sustained through 92 weeks. No new safety signals were observed (ClinicalTrials.gov number, NCT02407236).",2020,"Among all patients randomised in maintenance, symptomatic remission rates (stool frequency = 0/1; rectal bleeding = 0) at week 92 were, 64.5% and 67.6% in the ustekinumab q12w and q8w groups, respectively.","['moderate-to-severe ulcerative colitis (UC) from weeks 44 through 220', 'patients with UC']","['subcutaneous placebo', 'Ustekinumab', 'ustekinumab', 'placebo', 'ustekinumab 90\xa0mg every 12\xa0weeks [q12w], and 143 received ustekinumab 90\xa0mg q8w', 'Placebo']","['Safety', 'serious infections', 'Partial Mayo scores', 'symptomatic remission rates', 'fatal cardiac arrest', 'new safety signals', 'symptomatic remission']","[{'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1608841', 'cui_str': 'ustekinumab'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4517573', 'cui_str': '143'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0454788', 'cui_str': 'Mayo'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}]",,0.361164,"Among all patients randomised in maintenance, symptomatic remission rates (stool frequency = 0/1; rectal bleeding = 0) at week 92 were, 64.5% and 67.6% in the ustekinumab q12w and q8w groups, respectively.","[{'ForeName': 'Remo', 'Initials': 'R', 'LastName': 'Panaccione', 'Affiliation': 'Calgary, AB, Canada.'}, {'ForeName': 'Silvio', 'Initials': 'S', 'LastName': 'Danese', 'Affiliation': 'Milan, Italy.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Sandborn', 'Affiliation': 'La Jolla, CA, USA.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': ""O'Brien"", 'Affiliation': 'Spring House, PA, USA.'}, {'ForeName': 'Yiying', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Spring House, PA, USA.'}, {'ForeName': 'Hongyan', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Spring House, PA, USA.'}, {'ForeName': 'Omoniyi J', 'Initials': 'OJ', 'LastName': 'Adedokun', 'Affiliation': 'Spring House, PA, USA.'}, {'ForeName': 'Ilia', 'Initials': 'I', 'LastName': 'Tikhonov', 'Affiliation': 'Spring House, PA, USA.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Targan', 'Affiliation': 'Los Angeles, CA, USA.'}, {'ForeName': 'Maria T', 'Initials': 'MT', 'LastName': 'Abreu', 'Affiliation': 'Miami, FL, USA.'}, {'ForeName': 'Tadakazu', 'Initials': 'T', 'LastName': 'Hisamatsu', 'Affiliation': 'Tokyo, Japan.'}, {'ForeName': 'Ellen J', 'Initials': 'EJ', 'LastName': 'Scherl', 'Affiliation': 'New York, NY, USA.'}, {'ForeName': 'Rupert W', 'Initials': 'RW', 'LastName': 'Leong', 'Affiliation': 'Concord, NSW, Australia.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Rowbotham', 'Affiliation': 'Auckland, New Zealand.'}, {'ForeName': 'Ramesh P', 'Initials': 'RP', 'LastName': 'Arasaradnam', 'Affiliation': 'Coventry, UK.'}, {'ForeName': 'Bruce E', 'Initials': 'BE', 'LastName': 'Sands', 'Affiliation': 'New York, NY, USA.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Marano', 'Affiliation': 'Spring House, PA, USA.'}]",Alimentary pharmacology & therapeutics,['10.1111/apt.16119']
1872,33086450,[Short-term effect of sodium zirconium cyclosilicate on potassium lowering in chronic kidney disease patients with hyperkalemia].,"Objective:  To investigate the efficacy of sodium zirconium cyclosilicate on emergency correction of hyperkalemia in chronic kidney disease patients.  Methods:  Patients with chronic kidney disease who were admitted to the Department of Nephrology of the First Affiliated Hospital of Zhengzhou University from May to June 2020 were selected. Those who had hyperkalemia and took sodium zirconium cyclosilicate powder were finally included. The patient's clinical data and laboratory results were collected.  Results:  A total of 24 results were included from 21 patients. The age of patients was (48.9±13.5) years old. Fourteen patients were male, and 7 patients were female. After 2 hours of administration, the venous potassium level decreased from (5.85±0.52) mmol/L to (5.15±0.43) mmol/L ( P< 0.001,  n= 21), with an average decline of (0.71±0.43) mmol/L. Meanwhile, the arterial potassium level decreased from (5.50±0.40) mmol/L to (4.88±0.33) mmol/L ( P< 0.001,  n= 10), with an average decline of (0.62±0.29) mmol/L. Based on the initial venous potassium level, the patients were further divided into three groups. The average potassium decrease in < 5.5 mmol/L group (4 patients), 5.5-<6.0 mmol/L group (11 patients) and ≥6.0 mmol/L group (6 patients) was (0.46±0.26) mmol/L, (0.62±0.38) mmol/L and (1.04±0.45) mmol/L, respectively. There was statistically significant difference of potassium reduction among the three groups ( P= 0.045). Moreover, the extent of potassium reduction was positively correlated with baseline venous potassium level ( r= 0.603,  P= 0.004,  n= 21). The study did not reveal any treatment-related adverse event.  Conclusion:  Sodium zirconium cyclosilicate powder can rapidly and effectively reduce the serum potassium level in chronic kidney disease patients with hyperkalemia.",2020,There was statistically significant difference of potassium reduction among the three groups ( P= 0.045).,"['The age of patients was (48.9±13.5) years old', 'Fourteen patients were male, and 7 patients were female', 'Those who had hyperkalemia and took sodium zirconium cyclosilicate powder were finally included', 'chronic kidney disease patients', 'Patients with chronic kidney disease who were admitted to the Department of Nephrology of the First Affiliated Hospital of Zhengzhou University from May to June 2020 were selected', 'A total of 24 results were included from 21 patients', 'chronic kidney disease patients with hyperkalemia']","['Sodium zirconium cyclosilicate powder', 'sodium zirconium cyclosilicate']","['average potassium decrease', 'potassium reduction', 'serum potassium level', 'baseline venous potassium level', 'venous potassium level', 'arterial potassium level']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0020461', 'cui_str': 'Hyperkalemia'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C4045824', 'cui_str': 'sodium zirconium cyclosilicate'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0027712', 'cui_str': 'Nephrology'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]","[{'cui': 'C4045824', 'cui_str': 'sodium zirconium cyclosilicate'}, {'cui': 'C0032861', 'cui_str': 'Powder'}]","[{'cui': 'C0860866', 'cui_str': 'Potassium low'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0302353', 'cui_str': 'Serum potassium measurement'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0202194', 'cui_str': 'Potassium measurement'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}]",14.0,0.0112349,There was statistically significant difference of potassium reduction among the three groups ( P= 0.045).,"[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Bai', 'Affiliation': 'Department of Nephrology, the First Affiliated Hospital of Zhengzhou University, Zhengzhou 450052, China.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Shang', 'Affiliation': 'Department of Nephrology, the First Affiliated Hospital of Zhengzhou University, Zhengzhou 450052, China.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Kang', 'Affiliation': 'Department of Nephrology, the First Affiliated Hospital of Zhengzhou University, Zhengzhou 450052, China.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Yu', 'Affiliation': 'Department of Nephrology, the First Affiliated Hospital of Zhengzhou University, Zhengzhou 450052, China.'}, {'ForeName': 'F L', 'Initials': 'FL', 'LastName': 'Zhang', 'Affiliation': 'Department of Nephrology, the First Affiliated Hospital of Zhengzhou University, Zhengzhou 450052, China.'}, {'ForeName': 'W F', 'Initials': 'WF', 'LastName': 'Zhang', 'Affiliation': 'Department of Nephrology, the First Affiliated Hospital of Zhengzhou University, Zhengzhou 450052, China.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Wu', 'Affiliation': 'Department of Nephrology, the First Affiliated Hospital of Zhengzhou University, Zhengzhou 450052, China.'}, {'ForeName': 'R X', 'Initials': 'RX', 'LastName': 'Guo', 'Affiliation': 'Department of Nephrology, the First Affiliated Hospital of Zhengzhou University, Zhengzhou 450052, China.'}, {'ForeName': 'Y D', 'Initials': 'YD', 'LastName': 'Zhang', 'Affiliation': 'Department of Nephrology, the First Affiliated Hospital of Zhengzhou University, Zhengzhou 450052, China.'}, {'ForeName': 'Z Z', 'Initials': 'ZZ', 'LastName': 'Zhao', 'Affiliation': 'Department of Nephrology, the First Affiliated Hospital of Zhengzhou University, Zhengzhou 450052, China.'}]",Zhonghua yi xue za zhi,['10.3760/cma.j.cn112137-20200629-01990']
1873,33086453,[Evaluation of the analgesic effect of Acute Pain Service in thoracic surgery].,"Objective:  To observe the analgesic effect, complication and patient satisfaction of Acute Pain Service (APS) after thoracic surgery.  Methods:  The clinical data were collected from 264 patients who underwent different thoracic surgery from January 2017 until December 2019 retrospectively. They were divided into thoracotomy group (group O) and thoracoscopy surgery group (group T). There were 90 cases in group O and 174 cases in group T. According to the use of APS, the group O is divided into the no-APS group (group O1) and the APS group (group O2), the group T is divided into the no-APS group (group T1) and the APS group (group T2). The effect of postoperative analgesia, the incidence of nausea and vomiting and the satisfaction of patients were compared between group O1 and group O2, group T1 and group T2, respectively.  Results:  In the resting state, the Numeric Rating Scales (NRS) scores of the group O2 at 0 h (0.92±0.50 vs 1.59±0.62), 4 h (0.92±0.50 vs 2.06±1.03), 8 h (0.92±0.50 vs 2.18±1.13), 12 h (0.92±0.50 vs 2.47±1.42), 24 h (1.00±0.71 vs 2.53±1.42), and 48 h (1.00±0.71 vs 2.35±1.80) after leaving the Anesthesia Recovery Room (PACU) were significantly lower than those of the group O1 (all  P< 0.05), and in the active state, the NRS scores of the group O2 at 0 h ( P= 0.023), 4 h ( P= 0.001), 8 h ( P= 0.000), 12 h ( P= 0.001), 24 h ( P= 0.000), 48 h ( P= 0.000), and 72 h ( P= 0.019) after leaving the PACU were significantly lower than those of the group O1 (all  P< 0.05). In the resting state, the NRS scores of the group T2 at 4 h ( P= 0.029), 8 h ( P= 0.008), 12 h ( P= 0.006), and 24 h ( P= 0.013) after leaving the PACU were significantly lower than those of the group T1 (all  P< 0.05). In the active state, the NRS scores of the group T2 at 4 h ( P= 0.019), 8 h ( P= 0.000), 12 h ( P= 0.001), 24 h ( P= 0.002), and 48 h ( P= 0.002) after leaving the PACU were significantly lower than those of the group T1 (all  P< 0.05).  Conclusion:  APS can significantly reduce the NRS scores after thoracotomy and thoracoscopic surgery compared to ordinary analgesia model.",2020,"In the active state, the NRS scores of the group T2 at 4 h ( P= 0.019), 8 h ( P= 0.000), 12 h ( P= 0.001), 24 h ( P= 0.002), and 48 h ( P= 0.002) after leaving the PACU were significantly lower than those of the group T1 (all  P< 0.05).  ","['264 patients who underwent different thoracic surgery from January 2017 until December 2019 retrospectively', 'thoracic surgery']","['thoracoscopy surgery', 'Acute Pain Service']","['analgesic effect, complication and patient satisfaction of Acute Pain Service (APS', 'nausea and vomiting and the satisfaction', 'Numeric Rating Scales (NRS) scores', 'NRS scores', 'Anesthesia Recovery Room (PACU']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039986', 'cui_str': 'Thoracic surgery'}]","[{'cui': 'C0039989', 'cui_str': 'Thoracoscopy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0242934', 'cui_str': 'Acute pain service'}]","[{'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0242934', 'cui_str': 'Acute pain service'}, {'cui': 'C0001468', 'cui_str': ""Adenosine 5'-Phosphosulfate""}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0034871', 'cui_str': 'Postoperative anesthesia care unit'}]",,0.0384931,"In the active state, the NRS scores of the group T2 at 4 h ( P= 0.019), 8 h ( P= 0.000), 12 h ( P= 0.001), 24 h ( P= 0.002), and 48 h ( P= 0.002) after leaving the PACU were significantly lower than those of the group T1 (all  P< 0.05).  ","[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': 'Department of Anesthesiology, Zhejiang Hospital, Hangzhou, 310030, China.'}, {'ForeName': 'Y F', 'Initials': 'YF', 'LastName': 'Xia', 'Affiliation': 'Department of Anesthesiology, Zhejiang Hospital, Hangzhou, 310030, China.'}, {'ForeName': 'X M', 'Initials': 'XM', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesiology, Special Medical Center of PLA Air Force, Beijing, 100142, China.'}, {'ForeName': 'H M', 'Initials': 'HM', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Zhejiang Hospital, Hangzhou, 310030, China.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Qian', 'Affiliation': 'Department of Anesthesiology, Zhejiang Hospital, Hangzhou, 310030, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, Zhejiang Hospital, Hangzhou, 310030, China.'}]",Zhonghua yi xue za zhi,['10.3760/cma.j.cn112137-20200701-02011']
1874,33086512,Use of Metabolomic Profiling to Understand Variability in Adiposity Changes Following an Intentional Weight Loss Intervention in Older Adults.,"Inter-individual response to dietary interventions remains a major challenge to successful weight loss among older adults. This study applied metabolomics technology to identify small molecule signatures associated with a loss of fat mass and overall weight in a cohort of older adults on a nutritionally complete, high-protein diet. A total of 102 unique metabolites were measured using liquid chromatography-mass spectrometry (LC-MS) for 38 adults aged 65-80 years randomized to dietary intervention and 36 controls. Metabolite values were analyzed in both baseline plasma samples and samples collected following the six-month dietary intervention to consider both metabolites that could predict the response to diet and those that changed in response to diet or weight loss.Eight metabolites changed over the intervention at a nominally significant level: D-pantothenic acid, L-methionine, nicotinate, aniline, melatonin, deoxycarnitine, 6-deoxy-L-galactose, and 10-hydroxydecanoate. Within the intervention group, there was broad variation in the achieved weight-loss and dual-energy x-ray absorptiometry (DXA)-defined changes in total fat and visceral adipose tissue (VAT) mass. Change in the VAT mass was significantly associated with the baseline abundance of α-aminoadipate ( p  = 0.0007) and an additional mass spectrometry peak that may represent D-fructose, myo-inositol, mannose, α-D-glucose, allose, D-galactose, D-tagatose, or L-sorbose ( p  = 0.0001). This hypothesis-generating study reflects the potential of metabolomic biomarkers for the development of personalized dietary interventions.",2020,"Eight metabolites changed over the intervention at a nominally significant level: D-pantothenic acid, L-methionine, nicotinate, aniline, melatonin, deoxycarnitine, 6-deoxy-L-galactose, and 10-hydroxydecanoate.","['older adults', '38 adults aged 65-80 years randomized to', 'Older Adults']","['liquid chromatography-mass spectrometry (LC-MS', 'Intentional Weight Loss Intervention', 'dietary intervention']","['weight-loss and dual-energy x-ray absorptiometry (DXA)-defined changes in total fat and visceral adipose tissue (VAT) mass', 'Metabolite values']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0008565', 'cui_str': 'Liquid chromatography measurement'}, {'cui': 'C0037813', 'cui_str': 'Mass spectrometry measurement'}, {'cui': 'C1563041', 'cui_str': 'Intentional weight loss'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",38.0,0.03014,"Eight metabolites changed over the intervention at a nominally significant level: D-pantothenic acid, L-methionine, nicotinate, aniline, melatonin, deoxycarnitine, 6-deoxy-L-galactose, and 10-hydroxydecanoate.","[{'ForeName': 'Ellen E', 'Initials': 'EE', 'LastName': 'Quillen', 'Affiliation': 'Internal Medicine, Section on Molecular Medicine, Wake Forest School of Medicine, Winston-Salem, NC 27157, USA.'}, {'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Beavers', 'Affiliation': 'Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, NC 27101, USA.'}, {'ForeName': 'Anderson', 'Initials': 'A', 'LastName': ""O'Brien Cox"", 'Affiliation': 'Proteomics and Metabolomics Shared Resource, Comprehensive Cancer Center, Wake Forest School of Medicine, Winston-Salem, NC 27157, USA.'}, {'ForeName': 'Cristina M', 'Initials': 'CM', 'LastName': 'Furdui', 'Affiliation': 'Internal Medicine, Section on Molecular Medicine, Wake Forest School of Medicine, Winston-Salem, NC 27157, USA.'}, {'ForeName': 'Jingyun', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Internal Medicine, Section on Molecular Medicine, Wake Forest School of Medicine, Winston-Salem, NC 27157, USA.'}, {'ForeName': 'Ryan M', 'Initials': 'RM', 'LastName': 'Miller', 'Affiliation': 'Internal Medicine, Section on Gerontology and Geriatric Medicine, Wake Forest School of Medicine, Winston-Salem, NC 27157, USA.'}, {'ForeName': 'Hanzhi', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'Internal Medicine, Section on Molecular Medicine, Wake Forest School of Medicine, Winston-Salem, NC 27157, USA.'}, {'ForeName': 'Kristen M', 'Initials': 'KM', 'LastName': 'Beavers', 'Affiliation': 'Health and Exercise Science, Wake Forest University, Winston-Salem, NC 27109, USA.'}]",Nutrients,['10.3390/nu12103188']
1875,33087055,Selenium supplementation in patients with peripartum cardiomyopathy: a proof-of-concept trial.,"BACKGROUND


We studied the efficacy and safety of selenium supplementation in patients who had peripartum cardiomyopathy (PPCM) and selenium deficiency.
METHODS


We randomly assigned 100 PPCM patients with left ventricular ejection fraction (LVEF) < 45% and selenium deficiency (< 70 μg/L) to receive either oral Selenium (L-selenomethionine) 200 μg/day for 3 months or nothing, in addition to recommended therapy, in an open-label randomised trial. The primary outcome was a composite of persistence of heart failure (HF) symptoms, unrecovered LV systolic function (LVEF < 55%) or death from any cause.
RESULTS


Over a median of 19 months, the primary outcome occurred in 36 of 46 patients (78.3%) in the selenium group and in 43 of 54 patients (79.6%) in the control group (hazard ratio [HR] 0.69; 95% confidence interval [CI] 0.43-1.09; p = 0.113). Persistence of HF symptoms occurred in 18 patients (39.1%) in the selenium group and in 37 patients (68.5%) in the control group (HR 0.53; 95% CI 0.30-0.93; p = 0.006). LVEF < 55% occurred in 33 patients (71.7%) in the selenium group and in 38 patients (70.4%) in the control group (HR 0.91; 95% CI 0.57-1.45; p = 0.944). Death from any cause occurred in 3 patients (6.5%) in the selenium group and in 9 patients (16.7%) in the control group (HR 0.37; 95% CI 0.10-1.37; p = 0.137).
CONCLUSIONS


In this study, selenium supplementation did not reduce the risk of the primary outcome, but it significantly reduced HF symptoms, and there was a trend towards a reduction of all-cause mortality.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT03081949.",2020,"Over a median of 19 months, the primary outcome occurred in 36 of 46 patients (78.3%) in the selenium group and in 43 of 54 patients (79.6%) in the control group (hazard ratio [HR] 0.69; 95% confidence interval [CI] 0.43-1.09; p = 0.113).","['patients with peripartum cardiomyopathy', '100 PPCM patients with left ventricular ejection fraction (LVEF)\u2009<\u200945% and selenium deficiency (<\u200970\xa0μg/L', 'patients who had peripartum cardiomyopathy (PPCM) and selenium deficiency']","['selenium supplementation', 'LVEF\u2009', 'oral Selenium (L-selenomethionine) 200\xa0μg/day for 3\xa0months or nothing, in addition to recommended therapy', 'Selenium supplementation']","['Death', 'HF symptoms', 'composite of persistence of heart failure (HF) symptoms, unrecovered LV systolic function (LVEF\u2009<\u200955%) or death from any cause', 'Persistence of HF symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0877208', 'cui_str': 'Dilated cardiomyopathy secondary to peripartum heart disease'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0238421', 'cui_str': 'Selenium deficiency'}]","[{'cui': 'C0036581', 'cui_str': 'Selenium'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0036584', 'cui_str': 'Selenomethionine'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0546816', 'cui_str': 'Persistence'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}]",100.0,0.327032,"Over a median of 19 months, the primary outcome occurred in 36 of 46 patients (78.3%) in the selenium group and in 43 of 54 patients (79.6%) in the control group (hazard ratio [HR] 0.69; 95% confidence interval [CI] 0.43-1.09; p = 0.113).","[{'ForeName': 'Kamilu M', 'Initials': 'KM', 'LastName': 'Karaye', 'Affiliation': 'Department of Medicine, Bayero University, PO Box 4445, Kano, Nigeria. kkaraye@yahoo.co.uk.'}, {'ForeName': 'Hadiza', 'Initials': 'H', 'LastName': ""Sa'idu"", 'Affiliation': 'Department of Medicine, Bayero University, PO Box 4445, Kano, Nigeria.'}, {'ForeName': 'Suleiman A', 'Initials': 'SA', 'LastName': 'Balarabe', 'Affiliation': 'Department of Medicine, Muhammad Abdullahi Wase Specialist Hospital, Kano, Nigeria.'}, {'ForeName': 'Naser A', 'Initials': 'NA', 'LastName': 'Ishaq', 'Affiliation': 'Department of Medicine, Aminu Kano Teaching Hospital, Kano, Nigeria.'}, {'ForeName': 'Bushra', 'Initials': 'B', 'LastName': 'Sanni', 'Affiliation': 'Department of Medicine, Aminu Kano Teaching Hospital, Kano, Nigeria.'}, {'ForeName': 'Haruna', 'Initials': 'H', 'LastName': 'Abubakar', 'Affiliation': 'Department of Medicine, Aminu Kano Teaching Hospital, Kano, Nigeria.'}, {'ForeName': 'Baba Lawan', 'Initials': 'BL', 'LastName': 'Mohammed', 'Affiliation': 'Department of Medicine, Aminu Kano Teaching Hospital, Kano, Nigeria.'}, {'ForeName': 'Tijjani', 'Initials': 'T', 'LastName': 'Abdulsalam', 'Affiliation': 'Department of Medicine, Aminu Kano Teaching Hospital, Kano, Nigeria.'}, {'ForeName': 'Jamilu', 'Initials': 'J', 'LastName': 'Tukur', 'Affiliation': 'Department of Obstetrics and Gynaecology, Bayero University and Aminu Kano Teaching Hospital, Kano, Nigeria.'}, {'ForeName': 'Idris Y', 'Initials': 'IY', 'LastName': 'Mohammed', 'Affiliation': 'Department of Chemical Pathology, Bayero University and Aminu Kano Teaching Hospital, Kano, Nigeria.'}]",BMC cardiovascular disorders,['10.1186/s12872-020-01739-z']
1876,33087061,Evaluating the efficacy of an Advanced Care Planning Program for Health Decisions in patients with advanced heart failure: protocol for a Randomized Clinical Trial.,"BACKGROUND


An Advanced Care Planning (ACP) program of health decisions is the result of a process of reflection and relationship-building between the patient, their relatives and health professionals. It is based on respect for patients' autonomy, involving them in making decisions about their disease in a way that is shared between the medical team, the patient and their relatives. Up until now, the efficacy of an ACP has not been measured in the existing literature, and therefore it is unknown if these programs reach their goal. The main objective of our study is to evaluate the efficacy of an ACP program for decision-making in patients with advanced heart failure (HF) in comparison to usual follow up and care. This objective will be evaluated by the Patient Activation Measure test, which measures the participation and self-management of the patient in decision-making. Secondary objectives: to evaluate the effect of the program on quality of life, to know if the patients wishes expressed through the ACP program are fulfilled, to measure the impact of the program on patients' caregivers, to determine the satisfaction of patients included in the program and to evaluate the effect on quality of death.
METHODS


Randomized multicentre clinical trial at four hospitals in Madrid. Once they are included in the study, patients' allocation to groups (control vs intervention) will be made by alternative sampling. ACP will be applied to the intervention group, whereas in the Control Group usual follow-up will be carried out in HF units. All patients will fulfil questionnaires and tests related to the objectives of the study again after a 12-month follow-up period in order to gauge the effect of ACP in patients with advanced HF.
DISCUSSION


The characteristics of patients with advanced HF make them a model for designing ACP programs, given the high prevalence of this disease, the progressive increase in its incidence and it's clinical characteristics. Until now, the efficacy of this type of program has not been measured, so this Clinical Trial can provide relevant data for future ACP projects. Trial registration ClinicalTrials.gov Identifier: NCT04424680. Registered 9 June 2020. Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT04424680?term=NCT04424680&draw=2&rank=1 .",2020,"This objective will be evaluated by the Patient Activation Measure test, which measures the participation and self-management of the patient in decision-making.","['patients with advanced HF', 'patients with advanced heart failure (HF', 'patients with advanced heart failure', 'Randomized multicentre clinical trial at four hospitals in Madrid']","['Advanced Care Planning Program', 'ACP', 'ACP program']","['quality of death', 'quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0178916', 'cui_str': 'Care plan'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.0856781,"This objective will be evaluated by the Patient Activation Measure test, which measures the participation and self-management of the patient in decision-making.","[{'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Sánchez', 'Affiliation': 'Unidad de Medicina Interna, Hospital Universitario Fundación Alcorcón, Calle Budapest 1, 28922, Alcorcón, Madrid, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Guijarro', 'Affiliation': 'Unidad de Medicina Interna, Hospital Universitario Fundación Alcorcón, Calle Budapest 1, 28922, Alcorcón, Madrid, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Velasco', 'Affiliation': 'Unidad de Medicina Interna, Hospital Universitario Fundación Alcorcón, Calle Budapest 1, 28922, Alcorcón, Madrid, Spain.'}, {'ForeName': 'María Jesús', 'Initials': 'MJ', 'LastName': 'Vicente', 'Affiliation': 'Unidad de Medicina Interna, Hospital Universitario Fundación Alcorcón, Calle Budapest 1, 28922, Alcorcón, Madrid, Spain.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Galán', 'Affiliation': 'Unidad de Medicina Interna, Hospital Universitario Fundación Alcorcón, Calle Budapest 1, 28922, Alcorcón, Madrid, Spain.'}, {'ForeName': 'Benjamín', 'Initials': 'B', 'LastName': 'Herreros', 'Affiliation': 'Unidad de Medicina Interna, Hospital Universitario Fundación Alcorcón, Calle Budapest 1, 28922, Alcorcón, Madrid, Spain. benjaminherreros@gmail.com.'}]",BMC cardiovascular disorders,['10.1186/s12872-020-01738-0']
1877,33087074,"Effect of a telemedicine intervention for diabetes-related foot ulcers on health, well-being and quality of life: secondary outcomes from a cluster randomized controlled trial (DiaFOTo).","BACKGROUND


Follow-up care provided via telemedicine (TM) is intended to be a more integrated care pathway to manage diabetes-related foot ulcers (DFU) than traditionally-delivered healthcare. However, knowledge of the effect of TM follow-up on PROMs including self-reported health, well-being and QOL in patients with DFUs is lacking and often neglected in RCT reports in general. Therefore, in this study of secondary outcomes from the DiaFOTo trial, the aim was to compare changes in self-reported health, well-being and QOL between patients with DFUs receiving telemedicine follow-up care in primary healthcare in collaboration with specialist healthcare, and patients receiving standard outpatient care.
METHODS


The current study reports secondary endpoints from a cluster randomized controlled trial whose primary endpoint was ulcer healing time. The trial included 182 adults with diabetes-related foot ulcers (94/88 in the telemedicine/standard care groups) in 42 municipalities/districts, recruited from three clinical sites in Western Norway. Mean (SD) diabetes duration for the study population was 20.8 (15.0). The intervention group received care in the community in collaboration with specialist healthcare using an asynchronous telemedicine intervention. The intervention included an interactive web-based ulcer record and a mobile phone enabling counseling and communication between the community nurses and specialist healthcare; the control group received standard outpatient care. In total 156 participants (78/78) reported on secondary endpoints: self-reported health, well-being and quality of life evaluated by generic and disease-specific patient-reported outcome measures (e.g. Euro-QOL, the Hospital Anxiety and Depression Scale (HADS), Problem Areas in Diabetes (PAID), Neuropathy and Foot Ulcer-Specific Quality of Life Instrument (NeuroQOL)). Linear mixed-effects regression was used to investigate possible differences in changes in the scores between the intervention and control group at the end of follow-up.
RESULTS


In intention to treat analyses, differences between treatment groups were small and non-significant for the health and well-being scale scores, as well as for diabetes-related distress and foot ulcer-specific quality of life.
CONCLUSIONS


There were no significant differences in changes in scores for the patient reported outcomes between the intervention and control group, indicating that the intervention did not affect the participants' health, well-being and quality of life.
TRIAL REGISTRATION


Clinicaltrials.gov , NCT01710774 . Registered October 19th, 2012.",2020,"In intention to treat analyses, differences between treatment groups were small and non-significant for the health and well-being scale scores, as well as for diabetes-related distress and foot ulcer-specific quality of life.
","['patients with DFUs receiving telemedicine follow-up care in primary healthcare in collaboration with specialist healthcare, and patients receiving standard outpatient care', 'In total 156 participants (78/78) reported on', '182 adults with diabetes-related foot ulcers (94/88 in the telemedicine/standard care groups) in 42 municipalities/districts, recruited from three clinical sites in Western Norway']","['interactive web-based ulcer record and a mobile phone enabling counseling and communication between the community nurses and specialist healthcare; the control group received standard outpatient care', 'care in the community in collaboration with specialist healthcare using an asynchronous telemedicine intervention', 'telemedicine intervention', 'telemedicine (TM']","['diabetes-related foot ulcers on health, well-being and quality of life', 'diabetes-related distress and foot ulcer-specific quality of life', 'ulcer healing time', ""participants' health, well-being and quality of life"", 'Mean (SD) diabetes duration', 'secondary endpoints: self-reported health, well-being and quality of life evaluated by generic and disease-specific patient-reported outcome measures (e.g. Euro-QOL, the Hospital Anxiety and Depression Scale (HADS), Problem Areas in Diabetes (PAID), Neuropathy and Foot Ulcer-Specific Quality of Life Instrument (NeuroQOL']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C3899107', 'cui_str': 'Follow-Up Care'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0002423', 'cui_str': 'Outpatient Care'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0085119', 'cui_str': 'Ulcer of foot'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0028423', 'cui_str': 'Norway'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0562342', 'cui_str': 'Empowered'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0557521', 'cui_str': 'Community nurse'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0002423', 'cui_str': 'Outpatient Care'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0439581', 'cui_str': 'Asynchronous'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0085119', 'cui_str': 'Ulcer of foot'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C4277735', 'cui_str': 'Patient Reported Outcome Measures'}, {'cui': 'C1533125', 'cui_str': 'Euro'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}]",182.0,0.111224,"In intention to treat analyses, differences between treatment groups were small and non-significant for the health and well-being scale scores, as well as for diabetes-related distress and foot ulcer-specific quality of life.
","[{'ForeName': 'Marjolein M', 'Initials': 'MM', 'LastName': 'Iversen', 'Affiliation': 'Faculty of Health and Social Sciences, Department of Health and Caring Sciences, Western Norway University of Applied Sciences, N-5020, Bergen, Norway. miv@hvl.no.'}, {'ForeName': 'Jannicke', 'Initials': 'J', 'LastName': 'Igland', 'Affiliation': 'Faculty of Health and Social Sciences, Department of Health and Caring Sciences, Western Norway University of Applied Sciences, N-5020, Bergen, Norway.'}, {'ForeName': 'Hilde', 'Initials': 'H', 'LastName': 'Smith-Strøm', 'Affiliation': 'Faculty of Health and Social Sciences, Department of Health and Caring Sciences, Western Norway University of Applied Sciences, N-5020, Bergen, Norway.'}, {'ForeName': 'Truls', 'Initials': 'T', 'LastName': 'Østbye', 'Affiliation': 'Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Grethe S', 'Initials': 'GS', 'LastName': 'Tell', 'Affiliation': 'Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Svein', 'Initials': 'S', 'LastName': 'Skeie', 'Affiliation': 'Department of Research, Stavanger University Hospital, Stavanger, Norway.'}, {'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'Cooper', 'Affiliation': 'Department of Medicine, Section of Endocrinology, Stavanger University Hospital, Stavanger, Norway.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Peyrot', 'Affiliation': 'Faculty of Health and Social Sciences, Department of Health and Caring Sciences, Western Norway University of Applied Sciences, N-5020, Bergen, Norway.'}, {'ForeName': 'Marit', 'Initials': 'M', 'LastName': 'Graue', 'Affiliation': 'Faculty of Health and Social Sciences, Department of Health and Caring Sciences, Western Norway University of Applied Sciences, N-5020, Bergen, Norway.'}]",BMC endocrine disorders,['10.1186/s12902-020-00637-x']
1878,33087078,"Train the brain with music (TBM): brain plasticity and cognitive benefits induced by musical training in elderly people in Germany and Switzerland, a study protocol for an RCT comparing musical instrumental practice to sensitization to music.","BACKGROUND


Recent data suggest that musical practice prevents age-related cognitive decline. But experimental evidence remains sparse and no concise information on the neurophysiological bases exists, although cognitive decline represents a major impediment to healthy aging. A challenge in the field of aging is developing training regimens that stimulate neuroplasticity and delay or reverse symptoms of cognitive and cerebral decline. To be successful, these regimens should be easily integrated in daily life and intrinsically motivating. This study combines for the first-time protocolled music practice in elderly with cutting-edge neuroimaging and behavioral approaches, comparing two types of musical education.
METHODS


We conduct a two-site Hannover-Geneva randomized intervention study in altogether 155 retired healthy elderly (64-78) years, (63 in Geneva, 92 in Hannover), offering either piano instruction (experimental group) or musical listening awareness (control group). Over 12 months all participants receive weekly training for 1 hour, and exercise at home for ~ 30 min daily. Both groups study different music styles. Participants are tested at 4 time points (0, 6, and 12 months & post-training (18 months)) on cognitive and perceptual-motor aptitudes as well as via wide-ranging functional and structural neuroimaging and blood sampling.
DISCUSSION


We aim to demonstrate positive transfer effects for faculties traditionally described to decline with age, particularly in the piano group: executive functions, working memory, processing speed, abstract thinking and fine motor skills. Benefits in both groups may show for verbal memory, hearing in noise and subjective well-being. In association with these behavioral benefits we anticipate functional and structural brain plasticity in temporal (medial and lateral), prefrontal and parietal areas and the basal ganglia. We intend exhibiting for the first time that musical activities can provoke important societal impacts by diminishing cognitive and perceptual-motor decline supported by functional and structural brain plasticity.
TRIAL REGISTRATION


The Ethikkomission of the Leibniz Universität Hannover approved the protocol on 14.08.17 (no. 3604-2017), the neuroimaging part and blood sampling was approved by the Hannover Medical School on 07.03.18. The full protocol was approved by the Commission cantonale d'éthique de la recherche de Genève (no. 2016-02224) on 27.02.18 and registered at clinicaltrials.gov on 17.09.18 ( NCT03674931 , no. 81185).",2020,"We aim to demonstrate positive transfer effects for faculties traditionally described to decline with age, particularly in the piano group: executive functions, working memory, processing speed, abstract thinking and fine motor skills.","['altogether 155 retired healthy elderly (64-78) years, (63 in Geneva, 92 in Hannover), offering either', 'elderly people in Germany and Switzerland', 'elderly with cutting-edge neuroimaging and behavioral approaches']","['musical training', 'piano instruction (experimental group) or musical listening awareness (control group', 'Leibniz Universität']","['verbal memory, hearing in noise and subjective well-being', 'cognitive and perceptual-motor aptitudes as well as via wide-ranging functional and structural neuroimaging and blood sampling']","[{'cui': 'C0035345', 'cui_str': 'Retired'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0000925', 'cui_str': 'Incised wound'}, {'cui': 'C0205154', 'cui_str': 'Along edge'}, {'cui': 'C0679575', 'cui_str': 'Neuroimaging'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0004309', 'cui_str': 'Auditory Perception'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0679575', 'cui_str': 'Neuroimaging'}, {'cui': 'C0005834', 'cui_str': 'Collection of blood specimen for laboratory'}]",,0.046533,"We aim to demonstrate positive transfer effects for faculties traditionally described to decline with age, particularly in the piano group: executive functions, working memory, processing speed, abstract thinking and fine motor skills.","[{'ForeName': 'Clara E', 'Initials': 'CE', 'LastName': 'James', 'Affiliation': 'Geneva School of Health Sciences, Geneva Musical Minds Lab (GEMMI Lab), University of Applied Sciences and Arts Western Switzerland HES-SO, Avenue de Champel 47, 1206, Geneva, Switzerland. clara.james@hesge.ch.'}, {'ForeName': 'Eckart', 'Initials': 'E', 'LastName': 'Altenmüller', 'Affiliation': ""Institute for Music Physiology and Musicians' Medecine, Hannover University of Music, Drama and Media, Neues Haus 1, 30175, Hannover, Germany.""}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Kliegel', 'Affiliation': ""Faculty of Psychology and Educational Sciences, University of Geneva, Boulevard du Pont-d'Arve 40, 1205, Geneva, Switzerland.""}, {'ForeName': 'Tillmann H C', 'Initials': 'THC', 'LastName': 'Krüger', 'Affiliation': 'Center for Systems Neuroscience, Bünteweg 2, 30559, Hannover, Germany.'}, {'ForeName': 'Dimitri', 'Initials': 'D', 'LastName': 'Van De Ville', 'Affiliation': 'Swiss Federal Institute of Technology Lausanne (EPFL), Route Cantonale, 1015, Lausanne, Switzerland.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Worschech', 'Affiliation': ""Institute for Music Physiology and Musicians' Medecine, Hannover University of Music, Drama and Media, Neues Haus 1, 30175, Hannover, Germany.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Abdili', 'Affiliation': 'Geneva School of Health Sciences, Geneva Musical Minds Lab (GEMMI Lab), University of Applied Sciences and Arts Western Switzerland HES-SO, Avenue de Champel 47, 1206, Geneva, Switzerland.'}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Scholz', 'Affiliation': ""Institute for Music Physiology and Musicians' Medecine, Hannover University of Music, Drama and Media, Neues Haus 1, 30175, Hannover, Germany.""}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Jünemann', 'Affiliation': 'Center for Systems Neuroscience, Bünteweg 2, 30559, Hannover, Germany.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Hering', 'Affiliation': ""Faculty of Psychology and Educational Sciences, University of Geneva, Boulevard du Pont-d'Arve 40, 1205, Geneva, Switzerland.""}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Grouiller', 'Affiliation': 'Swiss Center for Affective Sciences, University of Geneva, 1205 Geneva, Switzerland. Campus Biotech, Chemin des Mines 9, 1202, Geneva, Switzerland.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Sinke', 'Affiliation': 'Center for Systems Neuroscience, Bünteweg 2, 30559, Hannover, Germany.'}, {'ForeName': 'Damien', 'Initials': 'D', 'LastName': 'Marie', 'Affiliation': 'Geneva School of Health Sciences, Geneva Musical Minds Lab (GEMMI Lab), University of Applied Sciences and Arts Western Switzerland HES-SO, Avenue de Champel 47, 1206, Geneva, Switzerland.'}]",BMC geriatrics,['10.1186/s12877-020-01761-y']
1879,33087119,"DESTINATION: a phase 3, multicentre, randomized, double-blind, placebo-controlled, parallel-group trial to evaluate the long-term safety and tolerability of tezepelumab in adults and adolescents with severe, uncontrolled asthma.","BACKGROUND


Tezepelumab is a human monoclonal antibody that blocks the activity of the epithelial cytokine thymic stromal lymphopoietin. The efficacy, safety and oral corticosteroid-sparing potential of tezepelumab are being investigated in two ongoing, phase 3, randomized, double-blind, placebo-controlled studies (NAVIGATOR [NCT03347279] and SOURCE [NCT03406078]). DESTINATION (NCT03706079) is a long-term extension (LTE) of these studies.
METHODS


DESTINATION is a randomized, double-blind, placebo-controlled LTE study in adults (18-80 years old) and adolescents (12-17 years old) with severe, uncontrolled asthma who are receiving treatment with medium- or high-dose inhaled corticosteroids plus at least one additional controller medication with or without oral corticosteroids. The study population will comprise patients who complete the 52- and 48-week NAVIGATOR and SOURCE studies, respectively. Patients who were randomized to receive tezepelumab 210 mg every 4 weeks (Q4W) in either predecessor study will continue to receive this regimen for 1 year; those who were previously randomized to receive placebo will be re-randomized (1:1) to receive either tezepelumab 210 mg Q4W or placebo for 1 year. Patients will receive their prescribed controller medications throughout DESTINATION and study physicians will have the opportunity to down- or up-titrate dosage of these medications, if appropriate. The primary objective is to evaluate the long-term safety and tolerability of tezepelumab over 104 weeks (inclusive of the treatment period of either predecessor study). The secondary objective is to assess the long-term effect of tezepelumab on asthma exacerbations. Patients recruited from SOURCE will be followed up post-treatment for 12 weeks. Patients recruited from NAVIGATOR who complete 100 weeks of tezepelumab treatment will be eligible for either 12 weeks of follow-up or a 36-week extended follow-up during which the clinical benefit of tezepelumab after treatment cessation will be investigated.
DISCUSSION


DESTINATION will evaluate the long-term safety, tolerability and efficacy of tezepelumab versus placebo with continued dosing for up to 2 years. DESTINATION will also evaluate the clinical effect of tezepelumab after treatment cessation. This LTE study aims to elucidate the long-term safety implications of receiving tezepelumab and to assess its potential long-term treatment benefits in patients with severe, uncontrolled asthma.
TRIAL REGISTRATION


NCT03706079 (ClinicalTrials.gov). Registered 15 October 2018.",2020,Patients who were randomized to receive tezepelumab 210 mg every 4 weeks (Q4W) in either predecessor study will continue to receive this regimen for 1 year; those who were previously randomized to receive placebo will be re-randomized (1:1) to receive either tezepelumab 210 mg Q4W or placebo for 1 year.,"['patients with severe, uncontrolled asthma', 'adults (18-80\xa0years old) and adolescents (12-17\xa0years old) with severe, uncontrolled asthma who are receiving treatment with medium- or high-dose inhaled corticosteroids plus at least one additional controller medication with or without oral corticosteroids', 'adults and adolescents with severe, uncontrolled asthma']","['tezepelumab 210\xa0mg Q4W or placebo', 'tezepelumab versus placebo', 'tezepelumab treatment', 'tezepelumab 210\xa0mg every 4\xa0weeks (Q4W', 'placebo', 'placebo-controlled LTE', 'tezepelumab']",['asthma exacerbations'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C4550163', 'cui_str': 'tezepelumab'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1275555', 'cui_str': 'Every four weeks'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0231448', 'cui_str': 'Extension'}]","[{'cui': 'C0349790', 'cui_str': 'Exacerbation of asthma'}]",,0.594677,Patients who were randomized to receive tezepelumab 210 mg every 4 weeks (Q4W) in either predecessor study will continue to receive this regimen for 1 year; those who were previously randomized to receive placebo will be re-randomized (1:1) to receive either tezepelumab 210 mg Q4W or placebo for 1 year.,"[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Menzies-Gow', 'Affiliation': 'Royal Brompton Hospital, Sydney Street, London, SW3 6NP, UK. A.Menzies-Gow@rbht.nhs.uk.'}, {'ForeName': 'Sandhia', 'Initials': 'S', 'LastName': 'Ponnarambil', 'Affiliation': 'Late Respiratory and Immunology, BioPharmaceuticals R&D, AstraZeneca, Cambridge, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Downie', 'Affiliation': 'Amgen, Thousand Oaks, CA, USA.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Bowen', 'Affiliation': 'Biometrics, Late Respiratory and Immunology, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Åsa', 'Initials': 'Å', 'LastName': 'Hellqvist', 'Affiliation': 'Biometrics, Late Respiratory and Immunology, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Gene', 'Initials': 'G', 'LastName': 'Colice', 'Affiliation': 'Late Respiratory and Immunology, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA.'}]",Respiratory research,['10.1186/s12931-020-01541-7']
1880,33087145,Re-esterified DHA improves ventilatory threshold 2 in competitive amateur cyclists.,"BACKGROUND


Fish oils were studied as ergogenic aids in a number of mixed physical trial designs showing promising results. However, the heterogeneous purity of the studied supplements, combined with the variety of physical tests employed call for more studies to confirm these findings, ideally with standardised supplements. Our aim was to test a supplement highly concentrated in DHA (DHA:EPA ratio equal to approximately 8:1) on a maximal cycling test to elucidate performance improvements mainly due to DHA.
METHODS


A double-blind, placebo controlled, randomised balanced, parallel design, in competitive amateur cyclists was employed. They were all male, older than 18 years old, with training routine of 2 to 4 sessions per week lasting at least one hour each. A ramp cycling test to exhaustion with a subsequent 5 min recovery phase was employed before and after treatment to analyse aerobic metabolism and lactate clearance after the bout. After 30 days of supplementation with 975 mg of re-esterified DHA, the thirty-eight cyclist who completed the study were finally included for statistical analysis.
RESULTS


Mean power output at ventilatory threshold 2 (VT2) improved after DHA supplementation both as absolute (△DHA versus △PLA: 6.33-26.54 Watts; CI 95%) and relative (p=0.006) values, paralleled with higher oxygen consumption at VT2 both for absolute (DHA 2729.4 ±304.5, 3045.9 ±335.0; PLA 2792.3 ±339.5, 2845.5 ±357.1; ml·min -1  baseline versus post p=0.025) and relative values (DHA 36.6 ±5.0, 41.2 ±5.4; PLA 37.2 ±5.7, 38.1 ±5.2; ml·kg -1 ·min -1  baseline versus post p=0.024). Heart rate recovery rate improved during the recovery phase in the DHA group compared to PLA (p=0.005).
CONCLUSION


DHA is capable of improving mean power output at the ventilatory threshold 2 (anaerobic ventilatory threshold) in amateur competitive cyclists. It is unclear if these findings are the result of the specific DHA supplement blend or another factor.",2020,"Heart rate recovery rate improved during the recovery phase in the DHA group compared to PLA (p=0.005).
","['competitive amateur cyclists', 'They were all male, older than 18 years old, with training routine of 2 to 4 sessions per week lasting at least one hour each', 'thirty-eight cyclist who completed the study were finally included for statistical analysis']","['Re-esterified DHA', 'placebo']","['Heart rate recovery rate', 'higher oxygen consumption', 'aerobic metabolism and lactate clearance']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C1457900', 'cui_str': 'Each'}, {'cui': 'C0450361', 'cui_str': '38'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0142831', 'cui_str': 'sodium dehydroacetate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0282636', 'cui_str': 'Respiration, Cell'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}]",,0.199896,"Heart rate recovery rate improved during the recovery phase in the DHA group compared to PLA (p=0.005).
","[{'ForeName': 'Vicente', 'Initials': 'V', 'LastName': 'Ávila-Gandía', 'Affiliation': 'Sports Physiology department, San Antonio Catholic University of Murcia (UCAM), Avenida de los Jerónimos, 135, Guadalupe (Murcia), 30107, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Torregrosa-García', 'Affiliation': 'Sports Physiology department, San Antonio Catholic University of Murcia (UCAM), Avenida de los Jerónimos, 135, Guadalupe (Murcia), 30107, Spain. atorregrosa@ucam.edu.'}, {'ForeName': 'Antonio J', 'Initials': 'AJ', 'LastName': 'Luque-Rubia', 'Affiliation': 'Sports Physiology department, San Antonio Catholic University of Murcia (UCAM), Avenida de los Jerónimos, 135, Guadalupe (Murcia), 30107, Spain.'}, {'ForeName': 'María Salud', 'Initials': 'MS', 'LastName': 'Abellán-Ruiz', 'Affiliation': 'Sports Physiology department, San Antonio Catholic University of Murcia (UCAM), Avenida de los Jerónimos, 135, Guadalupe (Murcia), 30107, Spain.'}, {'ForeName': 'Desirée', 'Initials': 'D', 'LastName': 'Victoria-Montesinos', 'Affiliation': 'Sports Physiology department, San Antonio Catholic University of Murcia (UCAM), Avenida de los Jerónimos, 135, Guadalupe (Murcia), 30107, Spain.'}, {'ForeName': 'F Javier', 'Initials': 'FJ', 'LastName': 'López-Román', 'Affiliation': 'Sports Physiology department, San Antonio Catholic University of Murcia (UCAM), Avenida de los Jerónimos, 135, Guadalupe (Murcia), 30107, Spain.'}]",Journal of the International Society of Sports Nutrition,['10.1186/s12970-020-00379-0']
1881,33087156,Getting to implementation: a protocol for a Hybrid III stepped wedge cluster randomized evaluation of using data-driven implementation strategies to improve cirrhosis care for Veterans.,"BACKGROUND


Cirrhosis is a rapidly increasing cause of global mortality. To improve cirrhosis care, the Veterans Health Administration (VHA) developed the Hepatic Innovation Team (HIT) Collaborative to support VA Medical Centers (VAMCs) to deliver evidence-based cirrhosis care. This randomized HIT program evaluation aims to develop and assess a novel approach for choosing and applying implementation strategies to improve the quality of cirrhosis care.
METHODS


Evaluation aims are to (1) empirically determine which combinations of implementation strategies are associated with successful implementation of evidence-based practices (EBPs) for Veterans with cirrhosis, (2) manualize these ""data-driven"" implementation strategies, and (3) assess the effectiveness of data-driven implementation strategies in increasing cirrhosis EBP uptake. Aim 1 will include an online survey of all VAMCs' use of 73 implementations strategies to improve cirrhosis care, as defined by the Expert Recommendations for Implementing Change taxonomy. Traditional statistical as well as configurational comparative methods will both be employed to determine which combinations of implementation strategies are associated with site-level adherence to EBPs for cirrhosis. In aim 2, semi-structured interviews with high-performing VAMCs will be conducted to operationalize successful implementation strategies for cirrhosis care. These data will be used to inform the creation of a step-by-step guide to tailoring and applying the implementation strategies identified in aim 1. In aim 3, this manualized implementation intervention will be assessed using a hybrid type III stepped-wedge cluster randomized design. This evaluation will be conducted in 12 VAMCs, with four VAMCs crossing from control to intervention every 6 months, in order to assess the effectiveness of using data-driven implementation strategies to improve guideline-concordant cirrhosis care.
DISCUSSION


Successful completion of this innovative evaluation will establish the feasibility of using early evaluation data to inform a manualized, user-friendly implementation intervention for VAMCs with opportunities to improve care. This evaluation will provide implementation support tools that can be applied to enhance the implementation of other evidence-based practices.
TRIAL REGISTRATION


This project was registered at ClinicalTrials.Gov ( NCT04178096 ) on 4/29/20.",2020,"Successful completion of this innovative evaluation will establish the feasibility of using early evaluation data to inform a manualized, user-friendly implementation intervention for VAMCs with opportunities to improve care.",['Veterans'],[],[],"[{'cui': 'C0042610', 'cui_str': 'Veterans'}]",[],[],,0.109469,"Successful completion of this innovative evaluation will establish the feasibility of using early evaluation data to inform a manualized, user-friendly implementation intervention for VAMCs with opportunities to improve care.","[{'ForeName': 'Shari S', 'Initials': 'SS', 'LastName': 'Rogal', 'Affiliation': 'Center for Health Equity Research and Promotion, VA Pittsburgh Healthcare System, Research Office Building (151R), University Drive C, Pittsburgh, PA, 15240, USA. Shari.Rogal@va.gov.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Yakovchenko', 'Affiliation': 'Center for Healthcare Organization and Implementation Research, Edith Nourse Rogers Memorial VA Hospital, Bedford, MA, USA.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Morgan', 'Affiliation': 'Gastroenterology Section, VA Long Beach Healthcare System, Long Beach, CA, USA.'}, {'ForeName': 'Jasmohan S', 'Initials': 'JS', 'LastName': 'Bajaj', 'Affiliation': 'Division of Gastroenterology, Hepatology, and Nutrition, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Gonzalez', 'Affiliation': 'Department of Veterans Affairs, Sierra Pacific Veterans Integrated Service Network, Pharmacy Benefits Management, Mather, CA, USA.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Park', 'Affiliation': 'Office of Healthcare Transformation, Veterans Engineering Resource Center, Washington, DC, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Beste', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, VA Puget Sound Healthcare System, Seattle, WA, USA.'}, {'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': 'Miech', 'Affiliation': 'Department of Veterans Affairs, Roudebush VA Medical Center, HSR&D Center for Health Information & Communication, VA PRIS-M QUERI, Indianapolis, IN, USA.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Lamorte', 'Affiliation': 'Center for Health Equity Research and Promotion, VA Pittsburgh Healthcare System, Research Office Building (151R), University Drive C, Pittsburgh, PA, 15240, USA.'}, {'ForeName': 'Brittney', 'Initials': 'B', 'LastName': 'Neely', 'Affiliation': 'Center for Health Equity Research and Promotion, VA Pittsburgh Healthcare System, Research Office Building (151R), University Drive C, Pittsburgh, PA, 15240, USA.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Gibson', 'Affiliation': 'Center for Health Equity Research and Promotion, VA Pittsburgh Healthcare System, Research Office Building (151R), University Drive C, Pittsburgh, PA, 15240, USA.'}, {'ForeName': 'Patrick S', 'Initials': 'PS', 'LastName': 'Malone', 'Affiliation': 'Duke University, Durham, NC, USA.'}, {'ForeName': 'Maggie', 'Initials': 'M', 'LastName': 'Chartier', 'Affiliation': 'HIV, Hepatitis and Related Conditions Programs, Office of Specialty Care Services, Veterans Health Administration, Washington, DC, USA.'}, {'ForeName': 'Tamar', 'Initials': 'T', 'LastName': 'Taddei', 'Affiliation': 'VA Connecticut Healthcare System, West Haven, CT, USA.'}, {'ForeName': 'Guadalupe', 'Initials': 'G', 'LastName': 'Garcia-Tsao', 'Affiliation': 'VA Connecticut Healthcare System, West Haven, CT, USA.'}, {'ForeName': 'Byron J', 'Initials': 'BJ', 'LastName': 'Powell', 'Affiliation': 'Brown School, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Jason A', 'Initials': 'JA', 'LastName': 'Dominitz', 'Affiliation': 'Gastroenterology Section, VA Puget Sound Health Care System, Seattle, WA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Ross', 'Affiliation': 'HIV, Hepatitis and Related Conditions Programs, Office of Specialty Care Services, Veterans Health Administration, Washington, DC, USA.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Chinman', 'Affiliation': 'Center for Health Equity Research and Promotion, VA Pittsburgh Healthcare System, Research Office Building (151R), University Drive C, Pittsburgh, PA, 15240, USA.'}]",Implementation science : IS,['10.1186/s13012-020-01050-7']
1882,33087159,"ASP5094, a humanized monoclonal antibody against integrin alpha-9, did not show efficacy in patients with rheumatoid arthritis refractory to methotrexate: results from a phase 2a, randomized, double-blind, placebo-controlled trial.","BACKGROUND


Rheumatoid arthritis (RA) is a chronic, debilitating autoimmune condition characterized by joint synovial inflammation. Current treatments include methotrexate (MTX), biologic agents, and Janus kinase (JAK) inhibitors. However, these agents are not efficacious in all patients and there are concerns regarding side effects and risk of infection as these treatments target immune-related pathways. Overexpression and activation of integrin alpha-9 (α9) on fibroblast-like synoviocytes are associated with RA disease onset and exacerbation. The humanized immunoglobulin G1 monoclonal antibody ASP5094 was designed to inhibit human α9 and is currently under investigation for the treatment of RA.
METHODS


This phase 2a, multicenter, randomized, placebo-controlled, double-blind, parallel-group study (NCT03257852) evaluated the efficacy, safety, and biological activity of intravenous ASP5094 10 mg/kg in patients with moderate to severe RA that was refractory to MTX. Patients received ASP5094 or placebo every 4 weeks for a total of three administrations. Both treatment groups used concomitant MTX. The primary efficacy endpoint was the proportion of patients who responded per American College of Rheumatology 50% improvement using C-reactive protein (ACR50-CRP) after 12 weeks of treatment. Biological activity of ASP5094 was assessed via pharmacokinetics and pharmacodynamics of known downstream effectors of α9. Safety was also assessed.
RESULTS


Sixty-six patients were enrolled and randomized to placebo (n = 33) or ASP5094 (n = 33). In the primary efficacy analysis, ACR50-CRP response rates were 6.3% and 18.2% at week 12 in the ASP5094 and placebo groups, respectively; a difference of - 11.9, which was not significant (2-sided P value = 0.258). No trends in ACR50 response rates were observed in subgroups based on demographics or baseline disease characteristics, and no significant differences between placebo and ASP5094 were identified in secondary efficacy or pharmacodynamic endpoints, despite achievement of target serum concentrations of ASP5094. Most treatment-emergent adverse events were mild to moderate in severity, and ASP5094 was considered safe and well tolerated overall.
CONCLUSION


Although no notable safety signals were observed in this study, ASP5094 was not efficacious in patients with moderate to severe RA with an inadequate response to MTX.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03257852 . Registered on 22 Aug. 2017.",2020,"No trends in ACR50 response rates were observed in subgroups based on demographics or baseline disease characteristics, and no significant differences between placebo and ASP5094 were identified in secondary efficacy or pharmacodynamic endpoints, despite achievement of target serum concentrations of ASP5094.","['patients with moderate to severe RA that was refractory to MTX', 'patients with rheumatoid arthritis refractory to', 'Sixty-six patients']","['ASP5094', 'methotrexate', 'intravenous ASP5094', 'concomitant MTX', 'methotrexate (MTX), biologic agents, and Janus kinase (JAK) inhibitors', 'placebo', 'ASP5094 or placebo']","['Safety', 'Overexpression and activation of integrin alpha-9', 'efficacy, safety, and biological activity', 'secondary efficacy or pharmacodynamic endpoints, despite achievement of target serum concentrations of ASP5094', 'proportion of patients who responded per American College of Rheumatology 50% improvement using C-reactive protein (ACR50-CRP', 'safe and well tolerated overall', 'ACR50 response rates', 'ACR50-CRP response rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C4517841', 'cui_str': '66'}]","[{'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0597721', 'cui_str': 'JAK Kinases'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2717020', 'cui_str': 'integrin alpha 9, human'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",66.0,0.623446,"No trends in ACR50 response rates were observed in subgroups based on demographics or baseline disease characteristics, and no significant differences between placebo and ASP5094 were identified in secondary efficacy or pharmacodynamic endpoints, despite achievement of target serum concentrations of ASP5094.","[{'ForeName': 'Tsutomu', 'Initials': 'T', 'LastName': 'Takeuchi', 'Affiliation': 'Keio University School of Medicine, 35 Shinanomachi, Shinjuku City, Tokyo, 160-8582, Japan. tsutake@z5.keio.jp.'}, {'ForeName': 'Yoshiya', 'Initials': 'Y', 'LastName': 'Tanaka', 'Affiliation': 'The First Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan.'}, {'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Erdman', 'Affiliation': 'Astellas Pharma Global Development, Northbrook, IL, USA.'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Kaneko', 'Affiliation': 'Astellas Pharma, Inc., Tokyo, Japan.'}, {'ForeName': 'Masako', 'Initials': 'M', 'LastName': 'Saito', 'Affiliation': 'Astellas Pharma, Inc., Tokyo, Japan.'}, {'ForeName': 'Chieri', 'Initials': 'C', 'LastName': 'Higashitani', 'Affiliation': 'Astellas Pharma, Inc., Tokyo, Japan.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Smulders', 'Affiliation': 'Astellas Pharma Global Development, Northbrook, IL, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Lademacher', 'Affiliation': 'Astellas Pharma Global Development, Northbrook, IL, USA.'}]",Arthritis research & therapy,['10.1186/s13075-020-02336-3']
1883,33087164,Mailed self-sample HPV testing kits to improve cervical cancer screening in a safety net health system: protocol for a hybrid effectiveness-implementation randomized controlled trial.,"BACKGROUND


Almost 20% of U.S. women remain at risk for cervical cancer due to their inability or unwillingness to participate in periodic clinic-based screening. Self-sampling has been shown to be an effective strategy for screening women for high-risk human papillomavirus (HR-HPV) infection in specific contexts. However, its effectiveness among medically underserved women in safety net health systems has not been evaluated. Furthermore, it is also unclear whether implementation strategies such as patient navigation can be used to improve the success of self-sample screening programs by addressing patient-level barriers to participation.
METHODS/DESIGN


The Prospective Evaluation of Self-Testing to Increase Screening (PRESTIS) trial is a hybrid type 2 effectiveness-implementation pragmatic randomized controlled trial of mailed self-sample HPV testing. The aim is to assess the effectiveness of mailed self-sample HPV testing kits to improve cervical cancer screening participation among patients in a safety net health system who are overdue for clinic-based screening, while simultaneously assessing patient navigation as an implementation strategy. Its setting is a large, urban safety net health system that serves a predominantly racial/ethnic minority patient population. The trial targets recruitment of 2268 participants randomized to telephone recall (enhanced usual care, n = 756), telephone recall with mailed self-sample HPV testing kit (intervention, n = 756), or telephone recall with mailed self-sample HPV testing kit and patient navigation (intervention + implementation strategy, n = 756). The primary effectiveness outcome is completion of primary screening, defined as completion and return of mailed self-sample kit or completion of a clinic-based Pap test. Secondary effectiveness outcomes are predictors of screening and attendance for clinical follow-up among women with a positive screening test. Implementation outcomes are reach, acceptability, fidelity, adaptations, and cost-effectiveness.
DISCUSSION


Hybrid designs are needed to evaluate the clinical effectiveness of self-sample HPV testing in specific populations and settings, while incorporating and evaluating methods to optimize its real-world implementation. The current manuscript describes the rationale and design of a hybrid type 2 trial of self-sample HPV testing in a safety net health system. Trial findings are expected to provide meaningful data to inform screening strategies to ultimately realize the global goal of eliminating cervical cancer.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03898167 . Registered on 01 April 2019.
TRIAL STATUS


Study start data: February 13, 2020. Recruitment status: Enrolling by invitation. Estimated primary completion date: February 15, 2023. Estimated study completion date: May 31, 2024. Protocol version 1.6 (February 25, 2020).",2020,Self-sampling has been shown to be an effective strategy for screening women for high-risk human papillomavirus (HR-HPV) infection in specific contexts.,"['Study start data: February 13, 2020', 'patients in a safety net health system who are overdue for clinic-based screening', '2268 participants randomized to', 'Recruitment status', 'medically underserved women']","['telephone recall (enhanced usual care, n\u2009=\u2009756), telephone recall with mailed self-sample HPV testing kit (intervention, n\u2009=\u2009756), or telephone recall with mailed self-sample HPV testing kit and patient navigation (intervention + implementation strategy, n\u2009=\u2009756', 'mailed self-sample HPV testing kits', 'Mailed self-sample HPV testing kits']","['predictors of screening and attendance for clinical follow-up among women with a positive screening test', 'completion of primary screening, defined as completion and return of mailed self-sample kit or completion of a clinic-based Pap test', 'reach, acceptability, fidelity, adaptations, and cost-effectiveness']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0812225', 'cui_str': 'Device kit'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3494323', 'cui_str': 'Patient Navigation'}]","[{'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0871311', 'cui_str': 'Screening test'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0812225', 'cui_str': 'Device kit'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0079104', 'cui_str': 'Smear cervix'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",2268.0,0.137692,Self-sampling has been shown to be an effective strategy for screening women for high-risk human papillomavirus (HR-HPV) infection in specific contexts.,"[{'ForeName': 'Jane R', 'Initials': 'JR', 'LastName': 'Montealegre', 'Affiliation': 'Center for Epidemiology and Population Health, Department of Pediatrics, Baylor College of Medicine, One Baylor Plaza, MS: 305, Houston, TX, 77030, USA. jrmontea@bcm.edu.'}, {'ForeName': 'Matthew L', 'Initials': 'ML', 'LastName': 'Anderson', 'Affiliation': 'Department of Obstetrics and Gynecology, Morsani College of Medicine, University of South Florida, Tampa, FL, USA.'}, {'ForeName': 'Susan G', 'Initials': 'SG', 'LastName': 'Hilsenbeck', 'Affiliation': 'Dan L Duncan Comprehensive Cancer Center, Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'Elizabeth Y', 'Initials': 'EY', 'LastName': 'Chiao', 'Affiliation': 'Department of Epidemiology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Scott B', 'Initials': 'SB', 'LastName': 'Cantor', 'Affiliation': 'Department of Health Services Research, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Parker', 'Affiliation': 'Dan L Duncan Comprehensive Cancer Center, Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Daheri', 'Affiliation': 'Harris Health System, Houston, TX, USA.'}, {'ForeName': 'Shaun', 'Initials': 'S', 'LastName': 'Bulsara', 'Affiliation': 'Dan L Duncan Comprehensive Cancer Center, Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'Betsy', 'Initials': 'B', 'LastName': 'Escobar', 'Affiliation': 'Dan L Duncan Comprehensive Cancer Center, Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'Ashish A', 'Initials': 'AA', 'LastName': 'Deshmukh', 'Affiliation': 'Center for Health Services Research, Department of Management, Policy, and Community Health, The University of Texas School of Public Health, Houston, TX, USA.'}, {'ForeName': 'Maria L', 'Initials': 'ML', 'LastName': 'Jibaja-Weiss', 'Affiliation': 'Dan L Duncan Comprehensive Cancer Center, Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Zare', 'Affiliation': 'Harris Health System, Houston, TX, USA.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Scheurer', 'Affiliation': 'Center for Epidemiology and Population Health, Department of Pediatrics, Baylor College of Medicine, One Baylor Plaza, MS: 305, Houston, TX, 77030, USA.'}]",Trials,['10.1186/s13063-020-04790-5']
1884,33087250,Metabolomic basis for response to high dose vitamin D in critical illness.,"BACKGROUND & AIMS


It is unclear if intervention can mitigate the dramatic alterations of metabolic homeostasis present in critical illness. Our objective was to determine the associations between increased 25-hydroxyvitamin D levels following high dose vitamin D 3  and more favorable metabolomic profiles in critical illness.
METHODS


We performed a post-hoc metabolomics study of the VITdAL-ICU randomized double-blind, placebo-controlled trial. Trial patients from Medical and Surgical Intensive Care Units at a tertiary university hospital with 25-hydroxyvitamin D level ≤20 ng/mL received either high dose oral vitamin D 3  (540,000 IU) or placebo. We performed an analysis of 578 metabolites from 1215 plasma samples from 428 subjects at randomization (day 0), day 3 and 7. Using mixed-effects modeling, we studied changes in metabolite profiles in subjects receiving intervention or placebo relative to absolute increases in 25-hydroxyvitamin D levels from day 0 to day 3.
RESULTS


55.2% of subjects randomized to high dose vitamin D 3  demonstrated an absolute increase in 25-hydroxyvitamin D ≥ 15 ng/ml from day 0 to day 3. With an absolute increase in 25-hydroxyvitamin D ≥ 15 ng/ml, multiple members of the sphingomyelin, plasmalogen, lysoplasmalogen and lysophospholipid metabolite classes had significantly positive Bonferroni corrected associations over time. Further, multiple representatives of the acylcarnitine and phosphatidylethanolamine metabolite classes had significantly negative Bonferroni corrected associations over time with an absolute increase in 25-hydroxyvitamin D ≥ 15 ng/ml. Changes in these highlighted metabolite classes were associated with decreased 28-day mortality.
CONCLUSIONS


Increases in 25-hydroxyvitamin D following vitamin D 3  intervention are associated with favorable changes in metabolites involved in endothelial protection, enhanced innate immunity and improved mitochondrial function.",2020,55.2% of subjects randomized to high dose vitamin D 3  demonstrated an absolute increase in 25-hydroxyvitamin D ≥ ,"['Trial patients from Medical and Surgical Intensive Care Units at a tertiary university hospital with 25-hydroxyvitamin D level ≤20\xa0ng/mL received either', '578 metabolites from 1215 plasma samples from 428 subjects at randomization (day 0), day 3 and 7', 'subjects receiving intervention or', '15']","['placebo', 'high dose oral vitamin D 3  (540,000 IU) or placebo']","['28-day mortality', '25-hydroxyvitamin D levels', '25-hydroxyvitamin D\xa0≥', 'metabolite profiles']","[{'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1948041', 'cui_str': 'Surgical and medical procedures'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0444263', 'cui_str': 'Plasma specimen'}, {'cui': 'C4517775', 'cui_str': '428'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}]",,0.65149,55.2% of subjects randomized to high dose vitamin D 3  demonstrated an absolute increase in 25-hydroxyvitamin D ≥ ,"[{'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Amrein', 'Affiliation': 'Division of Endocrinology and Diabetology, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Jessica A', 'Initials': 'JA', 'LastName': 'Lasky-Su', 'Affiliation': ""Channing Division of Network Medicine, Brigham and Women's Hospital, USA.""}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Dobnig', 'Affiliation': 'Thyroid Endocrinology Osteoporosis Institute Dobnig, Graz, Austria.'}, {'ForeName': 'Kenneth B', 'Initials': 'KB', 'LastName': 'Christopher', 'Affiliation': ""Division of Renal Medicine, Channing Division of Network Medicine, Brigham and Women's Hospital, USA. Electronic address: kbchristopher@bwh.harvard.edu.""}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2020.09.028']
1885,33087330,Expanded low allele frequency RAS and BRAF V600E testing in metastatic colorectal cancer as predictive biomarkers for cetuximab in the randomized CO.17 trial.,"BACKGROUND


Expanded RAS/BRAF mutations have not been assessed as predictive for single-agent cetuximab in metastatic colorectal cancer (mCRC) and low mutant allele frequency (MAF) mutations are of unclear significance. We aimed to establish cetuximab efficacy in optimally selected patients using highly sensitive BEAMing, capable of detecting alterations below standard clinical assays.
METHODS


CO.17 compared cetuximab versus best supportive care (BSC) in RAS/BRAF unselected mCRC. We performed RAS/BRAF analysis on micro-dissected tissue of 242 patients in CO.17 using BEAMing for KRAS/NRAS (codons 12/13/59/61/117/146) and BRAF V600E. Patients without BEAMing but with previous Sanger sequencing detected mutations were included.
RESULTS


KRAS, NRAS, and BRAF mutations were present in 53%, 4%, and 3% of tumors, respectively. Cetuximab improved overall survival (OS) (HR 0.51, 95% CI 0.32-0.81, P=0.004) and progression free survival (PFS) (HR 0.25, 95% CI 0.15-0.41, P<0.0001) compared to BSC in RAS/BRAF wild type patients. Cetuximab did not improve OS/PFS for KRAS, NRAS, or BRAF mutated tumors and tests of interaction confirmed expanded KRAS (P=0.0002) and NRAS (P=0.006) as predictive, while BRAF mutations were not (P=0.089). BEAMing identified 14% more tumors as RAS mutant than Sanger sequencing and cetuximab lacked activity in these patients. Mutations at MAF<5% were noted in 6/242 patients (2%). One patient with a KRAS A59T mutation (MAF=2%) responded to cetuximab. More NRAS than KRAS mutations were low MAF (OR 20.50, 95% CI 3.88-96.85, P=0.0038).
CONCLUSIONS


We establish single-agent cetuximab efficacy in optimally selected patients and show that subclonal RAS/BRAF alterations are uncommon and remain of indeterminate significance.",2020,"Cetuximab improved overall survival (OS) (HR 0.51, 95% CI 0.32-0.81, P=0.004) and progression free survival (PFS) (HR 0.25, 95% CI 0.15-0.41, P<0.0001) compared to BSC in RAS/BRAF wild type patients.",['metastatic colorectal cancer (mCRC) and'],"['Cetuximab', 'cetuximab versus best supportive care (BSC', 'cetuximab']","['overall survival (OS', 'KRAS, NRAS, and BRAF mutations', 'progression free survival (PFS', 'NRAS', 'OS/PFS for KRAS, NRAS, or BRAF mutated tumors and tests of interaction confirmed expanded KRAS']","[{'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}]","[{'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0344211', 'cui_str': 'Support'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1259929', 'cui_str': 'BRAF protein, human'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0205229', 'cui_str': 'Expanding'}]",242.0,0.136332,"Cetuximab improved overall survival (OS) (HR 0.51, 95% CI 0.32-0.81, P=0.004) and progression free survival (PFS) (HR 0.25, 95% CI 0.15-0.41, P<0.0001) compared to BSC in RAS/BRAF wild type patients.","[{'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Loree', 'Affiliation': 'Medical Oncology, BC Cancer.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Dowers', 'Affiliation': 'University of Melbourne.'}, {'ForeName': 'Dongsheng', 'Initials': 'D', 'LastName': 'Tu', 'Affiliation': ""Canadian Cancer Trials Group, Queen's University.""}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Jonker', 'Affiliation': 'Division of Medical Oncology, University of Ottawa, Ottawa Hospital Research Institute.'}, {'ForeName': 'Daniel L', 'Initials': 'DL', 'LastName': 'Edelstein', 'Affiliation': 'Medical Scientific Affairs, Sysmex Innostics.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Quinn', 'Affiliation': 'Sysmex Inostics.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Holtrup', 'Affiliation': 'Research & Development, Sysmex Inostics GmbH.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Price', 'Affiliation': 'Oncology, Queen Elizabeth Hospital.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Zalcberg', 'Affiliation': 'Alfred Health and School of Public Health and Preventive Medicine (SPHPM), Monash University.'}, {'ForeName': 'Malcolm J', 'Initials': 'MJ', 'LastName': 'Moore', 'Affiliation': 'BC Cancer Agency.'}, {'ForeName': 'Christos S', 'Initials': 'CS', 'LastName': 'Karapetis', 'Affiliation': 'Medical Oncology, Flinders University and Flinders Medical Centre.'}, {'ForeName': 'Chris J', 'Initials': 'CJ', 'LastName': ""O'Callaghan"", 'Affiliation': 'Public Health Sciences, Canadian Cancer Trials Group.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Waring', 'Affiliation': 'Department of Pathology, University of Melbourne.'}, {'ForeName': 'Hagen F', 'Initials': 'HF', 'LastName': 'Kennecke', 'Affiliation': 'Department of Medical Oncology,, BC Cancer Agency.'}, {'ForeName': 'Stanley R', 'Initials': 'SR', 'LastName': 'Hamilton', 'Affiliation': 'Pathology, City of Hope.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Kopetz', 'Affiliation': 'Gastrointestinal Medical Oncology, University of Texas MD Anderson Cancer Center skopetz@mdanderson.org.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-2710']
1886,33087377,Brief compression-only cardiopulmonary resuscitation and automated external defibrillator course for secondary school students: a multischool feasibility study.,"OBJECTIVES


This study assessed the feasibility and preliminary efficacy of a 2-hour compression-only cardiopulmonary resuscitation and automated external defibrillator (CO-CPRAED) course in secondary school students.
DESIGN


Prospective pre-post feasibility study.
SETTING AND PARTICIPANTS


128 students (12-15 years old) without prior basic life support (BLS) training at four secondary schools in Hong Kong. All students were followed up at 3 months after training.
INTERVENTIONS


Emergency medicine-trained nurse and physicians taught the 2-hour CO-CPRAED course using the American Heart Association 'CPR in School Training Kit' programme. Students were trained in groups up to 40 students/session, with an instructor to student ratio not exceeding 1:10. To practise hands-on compressions, the manikin to student ratio was 1:1. For a simulated cardiac arrest, the manikin and AED to student ratio was 1:10.
PRIMARY AND SECONDARY OUTCOMES


CPR and AED knowledge, attitude statements towards bystander CPR and AED, quality of BLS performance skills during training and at 3 months.
RESULTS


Some students (46%) knew how deep to push on an adult chest when doing CO-CPR before training. The course was associated with an increase in knowledge score (pretraining 55%, post-training 93%; adjusted mean difference (MD) 38%, 95% CI 33% to 43%; p<0.001). Most students (68%) thought that CPR education in senior secondary school was essential before training. The students had a very positive attitude towards CPR; no change in the mean (SD) attitude score out of 30 over time (pretraining 27.2 (2.5), post-training 27.6 (2.7); adjusted MD 0.5, 95% CI -0.1 to 1.0; p=0.132). Most students were competent in performing BLS immediately after training (77%) and at 3 months (83%) (adjusted MD 6%, 95% CI -4% to 15%; p=0.268).
CONCLUSIONS


The results demonstrate the feasibility of scaling up the number of secondary schools trained in a brief CO-CPRAED course within the local school curriculum.",2020,"Most students were competent in performing BLS immediately after training (77%) and at 3 months (83%) (adjusted MD 6%, 95% CI -4% to 15%; p=0.268).
","['128 students (12-15 years old) without prior basic life support', 'secondary school students']","[""Emergency medicine-trained nurse and physicians taught the 2-hour CO-CPRAED course using the American Heart Association 'CPR in School Training Kit' programme"", 'Brief compression-only cardiopulmonary resuscitation and automated external defibrillator course', '2-hour compression-only cardiopulmonary resuscitation and automated external defibrillator (CO-CPRAED']","['CPR and AED knowledge, attitude statements towards bystander CPR and AED, quality of BLS performance skills', 'mean (SD) attitude score', 'knowledge score']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0085873', 'cui_str': 'Basic life support'}, {'cui': 'C0036530', 'cui_str': 'Secondary school'}]","[{'cui': 'C0013964', 'cui_str': 'Emergency medicine'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C1292425', 'cui_str': '2 hours'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0180309', 'cui_str': 'Automated External Defibrillators'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0002458', 'cui_str': 'American Heart Association'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0812225', 'cui_str': 'Device kit'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}]","[{'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0180309', 'cui_str': 'Automated External Defibrillators'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0085873', 'cui_str': 'Basic life support'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",128.0,0.0220888,"Most students were competent in performing BLS immediately after training (77%) and at 3 months (83%) (adjusted MD 6%, 95% CI -4% to 15%; p=0.268).
","[{'ForeName': 'Kit Ying', 'Initials': 'KY', 'LastName': 'So', 'Affiliation': 'Accident and Emergency Medicine, Queen Elizabeth Hospital, Kowloon, Hong Kong SAR, China.'}, {'ForeName': 'Hiu Fai', 'Initials': 'HF', 'LastName': 'Ko', 'Affiliation': 'Accident and Emergency Medicine, Queen Elizabeth Hospital, Kowloon, Hong Kong SAR, China.'}, {'ForeName': 'Cindy Sin Yui', 'Initials': 'CSY', 'LastName': 'Tsui', 'Affiliation': 'Anaesthesia and Intensive Care, Prince of Wales Hospital, Shatin, Hong Kong SAR, China.'}, {'ForeName': 'Chi Yeung', 'Initials': 'CY', 'LastName': 'Yeung', 'Affiliation': 'Accident and Emergency Medicine, Queen Elizabeth Hospital, Kowloon, Hong Kong SAR, China.'}, {'ForeName': 'Yee Ching', 'Initials': 'YC', 'LastName': 'Chu', 'Affiliation': 'Accident and Emergency Medicine, Queen Elizabeth Hospital, Kowloon, Hong Kong SAR, China.'}, {'ForeName': 'Veronica Ka Wai', 'Initials': 'VKW', 'LastName': 'Lai', 'Affiliation': 'Anaesthesia and Intensive Care, The Chinese University of Hong Kong, Shatin, Hong Kong SAR, China.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Lee', 'Affiliation': 'Anaesthesia and Intensive Care, The Chinese University of Hong Kong, Shatin, Hong Kong SAR, China annalee@cuhk.edu.hk.'}]",BMJ open,['10.1136/bmjopen-2020-040469']
1887,33087406,A Cognitive Aid for Neonatal Epinephrine Dosing.,"OBJECTIVES


Errors are common when preparing epinephrine for neonatal resuscitation. Epinephrine is available in two concentrations (1 mg/mL and 1 mg/10 mL) and requires weight-based calculations, which increases the risk of dosing errors. We developed a printed cognitive aid to assist with dose preparation. We hypothesized that the cognitive aid would result in a 25% difference in errors in preparing the dose of epinephrine during simulated neonatal resuscitation.
METHODS


Nurses ( N  = 100) in a large academic and community hospital were randomly assigned to calculate the intended dose and prepare epinephrine for neonatal resuscitation with or without the cognitive aid. Scenarios were video recorded and timed. Secondary outcomes included errors in the written intended dose, errors in choosing the correct epinephrine concentration, and time required to prepare the final dose. Proportions were compared by using Fisher's exact test. Variables influencing dosing errors were investigated by using logistic regression.
RESULTS


Using the cognitive aid significantly decreased the proportion of doses prepared incorrectly (24% vs 50%;  P  = .01). The aid also decreased errors in choosing the correct epinephrine concentration (12% vs 44%;  P  < .001), but there was no difference in the written intended dose or the time to prepare the dose. Years of experience, self-perceived math comfort, and anxiety were not predictive of dosing errors.
CONCLUSIONS


A simple cognitive aid decreased epinephrine dosing errors during simulated neonatal resuscitation but did not improve efficiency. Despite the effectiveness of the cognitive aid, errors were not completely eliminated. This is a serious safety risk for newborns and requires additional interventions.",2020,Using the cognitive aid significantly decreased the proportion of doses prepared incorrectly (24% vs 50%;  P  = .01).,['Nurses ( N  = 100) in a large academic and community hospital'],"['epinephrine', 'Epinephrine', 'epinephrine for neonatal resuscitation with or without the cognitive aid']","['Years of experience, self-perceived math comfort, and anxiety', 'errors in the written intended dose, errors in choosing the correct epinephrine concentration, and time required to prepare the final dose', 'correct epinephrine concentration']","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0020003', 'cui_str': 'Community hospital'}]","[{'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0024934', 'cui_str': 'Mathematics'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}]",,0.0443206,Using the cognitive aid significantly decreased the proportion of doses prepared incorrectly (24% vs 50%;  P  = .01).,"[{'ForeName': 'Kate D', 'Initials': 'KD', 'LastName': 'Brune', 'Affiliation': 'Department of Pediatrics, St Joseph Mercy Hospital, Ann Arbor, Michigan.'}, {'ForeName': 'Varsha', 'Initials': 'V', 'LastName': 'Bhatt-Mehta', 'Affiliation': 'Department of Clinical Pharmacy, College of Pharmacy and.'}, {'ForeName': 'Deborah M', 'Initials': 'DM', 'LastName': 'Rooney', 'Affiliation': 'Department of Learning Health Sciences, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'John T', 'Initials': 'JT', 'LastName': 'Adams', 'Affiliation': ""Department of Pediatrics, Ascension St John Children's Hospital, Detroit, Michigan; and.""}, {'ForeName': 'Gary M', 'Initials': 'GM', 'LastName': 'Weiner', 'Affiliation': ""Division of Neonatal-Perinatal Medicine, Department of Pediatrics, Michigan Medicine, University of Michigan and C.S. Mott Children's Hospital, Ann Arbor, Michigan gweiner@med.umich.edu.""}]",Hospital pediatrics,['10.1542/hpeds.2020-000299']
1888,33087441,Beta blockers versus calcium channel blockers for provocation of vasospastic angina after drug-eluting stent implantation: a multicentre prospective randomised trial.,"BACKGROUND


Drug-eluting stent-induced vasospastic angina (DES-VSA) has emerged as a novel complication in the modern era of percutaneous coronary intervention (PCI). Although beta blockers (BBs) are generally recommended for coronary heart disease, they may promote incidence of DES-VSA. This study aimed to compare the effects of calcium channel blockers (CCBs) perceived to be protective against DES-VSA and BBs on subsequent coronary events after second-generation drug-eluting stent implantation.
METHODS


In this multicentre prospective, randomised study, 52 patients with coronary artery disease who underwent PCI for a single-vessel lesion with everolimus-eluting stent placement were randomised into post-stenting BB (N=26) and CCB (N=26) groups and followed for 24 months to detect any major cardiovascular events (MACE). A positive result on acetylcholine provocation testing during diagnostic coronary angiography (CAG) at 9 months was the primary endpoint for equivalence. MACE included all-cause death, non-fatal myocardial infarction, unstable angina, cerebrovascular disease or coronary revascularisation for stable coronary artery disease after index PCI.
RESULTS


At 9 months, 42 patients (80.8%) underwent diagnostic coronary angiography and acetylcholine provocation testing. Among them, seven patients in each group were diagnosed with definite vasospasm (intention-to-treat analysis 26.9% vs 26.9%, risk difference 0 (-0.241, 0.241)). Meanwhile, the secondary endpoint, 24-month MACE, was higher in the CCB group (19.2%) than in the BB group (3.8%) (p=0.01). In detail, coronary revascularisation for stable coronary artery disease was the predominant endpoint that contributed to the greater proportion of MACE in the CCB group (CCB (19.2%) vs BB (3.8%), p=0.03).
CONCLUSIONS


The incidence of acetylcholine-induced coronary artery spasms did not differ between patients receiving BBs or CCBs at 9 months after PCI. However, a higher incidence of 2-year MACE was observed in the CCB group, suggesting the importance of BB administration.
TRIAL REGISTRATION NUMBER


This study was registered at the Japanese University Hospital Medical Information Network (UMIN) Clinical Trial Registry (The Prospective Randomized Trial for Optimizing Medical Therapy After Stenting: Calcium-Beta Trial; UMIN000008321, https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009536).",2020,The incidence of acetylcholine-induced coronary artery spasms did not differ between patients receiving BBs or CCBs at 9 months after PCI.,"['Japanese University Hospital Medical Information Network (UMIN', '52 patients with coronary artery disease who underwent PCI for a single-vessel lesion with everolimus-eluting stent placement', 'vasospastic angina after drug-eluting stent implantation']","['MACE', 'calcium channel blockers', 'CCB', 'post-stenting BB', 'calcium channel blockers (CCBs', 'beta blockers (BBs', 'Medical Therapy', 'diagnostic coronary angiography and acetylcholine provocation testing', 'Beta blockers', 'diagnostic coronary angiography (CAG']","['incidence of acetylcholine-induced coronary artery spasms', 'diagnosed with definite vasospasm', 'cause death, non-fatal myocardial infarction, unstable angina, cerebrovascular disease or coronary revascularisation', '2-year MACE']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0021419', 'cui_str': 'Information Networks'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0522776', 'cui_str': 'Placement of stent'}, {'cui': 'C0002963', 'cui_str': 'Prinzmetal angina'}, {'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0006684', 'cui_str': 'Calcium channel blocker'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0001645', 'cui_str': 'Beta adrenergic receptor antagonist'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C0001041', 'cui_str': 'Acetylcholine'}, {'cui': 'C0449428', 'cui_str': 'Provocation'}, {'cui': 'C0392366', 'cui_str': 'Tests'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0001041', 'cui_str': 'Acetylcholine'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0010073', 'cui_str': 'Coronary artery spasm'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0439544', 'cui_str': 'Definite'}, {'cui': 'C0042396', 'cui_str': 'Vascular constriction'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0002965', 'cui_str': 'Impending infarction'}, {'cui': 'C0007820', 'cui_str': 'Cerebrovascular disease'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",52.0,0.125692,The incidence of acetylcholine-induced coronary artery spasms did not differ between patients receiving BBs or CCBs at 9 months after PCI.,"[{'ForeName': 'Mitsuaki', 'Initials': 'M', 'LastName': 'Sawano', 'Affiliation': 'Department of Cardiology, Keio University School of Medicine, Shinjuku-ku, Tokyo, Japan.'}, {'ForeName': 'Toshiomi', 'Initials': 'T', 'LastName': 'Katsuki', 'Affiliation': 'Department of Cardiology, Keio University School of Medicine, Shinjuku-ku, Tokyo, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Kitai', 'Affiliation': 'Department of Cardiovascular Medicine, Kobe City Medical Center General Hospital, Kobe, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Tamita', 'Affiliation': 'Department of Cardiology, Nishinomiya Watanabe Cardiovascular Center, Nishinomiya, Hyogo, Japan.'}, {'ForeName': 'Kotaro', 'Initials': 'K', 'LastName': 'Obunai', 'Affiliation': 'Department of Cardiology, Tokyo Bay Urayasu Ichikawa Medical Center, Ichikawa, Japan.'}, {'ForeName': 'Yukinori', 'Initials': 'Y', 'LastName': 'Ikegami', 'Affiliation': 'Department of Cardiology, National Hospital Organisation Tokyo Medical Center, Meguro-ku, Tokyo, Japan.'}, {'ForeName': 'Takafumi', 'Initials': 'T', 'LastName': 'Yamane', 'Affiliation': 'Department of Cardiovascular Medicine, Kobe City Medical Center General Hospital, Kobe, Japan.'}, {'ForeName': 'Ikuko', 'Initials': 'I', 'LastName': 'Ueda', 'Affiliation': 'Department of Cardiology, Keio University School of Medicine, Shinjuku-ku, Tokyo, Japan.'}, {'ForeName': 'Ayaka', 'Initials': 'A', 'LastName': 'Endo', 'Affiliation': 'Department of Cardiology, Saiseikai Central Hospital, Minato-ku, Tokyo, Japan.'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Maekawa', 'Affiliation': 'Division of Cardiology, Internal Medicine III, Hamamatsu University School of Medicine, Hamamatsu, Shizuoka, Japan.'}, {'ForeName': 'Akio', 'Initials': 'A', 'LastName': 'Kawamura', 'Affiliation': 'Department of Cardiology, International University of Health and Welfare Faculty of Medicine Graduate School of Medicine, Narita, Chiba, Japan.'}, {'ForeName': 'Keiichi', 'Initials': 'K', 'LastName': 'Fukuda', 'Affiliation': 'Department of Cardiology, Keio University School of Medicine, Shinjuku-ku, Tokyo, Japan.'}, {'ForeName': 'Shun', 'Initials': 'S', 'LastName': 'Kohsaka', 'Affiliation': 'Department of Cardiology, Keio University School of Medicine, Shinjuku-ku, Tokyo, Japan sk@keio.jp.'}]",Open heart,['10.1136/openhrt-2020-001406']
1889,33087480,Total knee arthroplasty under quadruple nerve block with ropivacaine 0.32%: effect of addition of intravenous dexmedetomidine to intravenous dexamethasone on analgesic duration.,"BACKGROUND AND OBJECTIVES


Peripheral nerve blocks reduce postoperative pain and enhance recovery after total knee arthroplasty (TKA). This study aims to assess the benefits of addition of intravenous dexmedetomidine (DexM) to intravenous dexamethasone on the analgesic duration of quadruple nerve blocks.
METHODS


This double-blind, randomized, controlled trial prospectively enrolled 90 patients scheduled for TKA under quadruple nerve blocks (sciatic, femoral, obturator, and lateral femoral cutaneous nerves blocks) with 70 mL, 0.32% ropivacaine. All patients received systemic dexamethasone 10 mg. Patients were randomized to receive DexM (2 µg/kg, intravenous) or placebo (1:1 ratio). The primary endpoint was the duration of analgesia defined as the time to first request for rescue analgesia (oxycodone).
RESULTS


Kaplan-Meier curves for the first analgesic request were similar between groups (log-rank test; p=0.27). Median (IQR) duration of analgesia was similar between placebo (1575 min (1211-1952)) and DexM (1470 min (1263-1700)) groups (p=0.56). Cumulative consumption of oxycodone at the 48th hour was 20 mg (10-30) and 30 mg (20-40) in placebo and DexM groups, respectively (p=0.14). The day after surgery, 93% and 89% of patients were able to walk in placebo and DexM groups, respectively (p=0.46). Intravenous DexM was associated with bradycardia, hypotension and longer recovery room stay (p<0.05 for all comparisons).
CONCLUSIONS


In a multimodal analgesic regimen, addition of systemic DexM (2 µg/kg) to systemic dexamethasone does not prolong the analgesic duration of quadruple nerve block with ropivacaine 0.32% after TKA.
TRIAL REGISTRATION NUMBER


NCT03834129.",2020,"Intravenous DexM was associated with bradycardia, hypotension and longer recovery room stay (p<0.05 for all comparisons).
","['total knee arthroplasty (TKA', 'enrolled 90 patients scheduled for TKA under quadruple nerve blocks (sciatic, femoral, obturator, and lateral femoral cutaneous nerves blocks) with 70\u2009mL, 0.32']","['ropivacaine', 'Intravenous DexM', 'DexM', 'dexamethasone', 'placebo', 'dexmedetomidine (DexM', 'dexmedetomidine', 'systemic dexamethasone']","['duration of analgesia defined as the time to first request for rescue analgesia (oxycodone', 'bradycardia, hypotension and longer recovery room stay', 'Median (IQR) duration of analgesia', 'analgesic duration of quadruple nerve block', 'Cumulative consumption of oxycodone', 'analgesic duration']","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0205175', 'cui_str': 'Quadruple'}, {'cui': 'C0027741', 'cui_str': 'Nerve block'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0182021', 'cui_str': 'Obturator'}, {'cui': 'C0394740', 'cui_str': 'Local anesthetic lateral femoral cutaneous nerve block'}, {'cui': 'C4517448', 'cui_str': '0.32'}]","[{'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0686900', 'cui_str': 'Request for'}, {'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0034871', 'cui_str': 'Postoperative anesthesia care unit'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0205175', 'cui_str': 'Quadruple'}, {'cui': 'C0027741', 'cui_str': 'Nerve block'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",90.0,0.738115,"Intravenous DexM was associated with bradycardia, hypotension and longer recovery room stay (p<0.05 for all comparisons).
","[{'ForeName': 'Clement', 'Initials': 'C', 'LastName': 'Chassery', 'Affiliation': 'Anesthesia, Clinique Medipole Garonne, Toulouse, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Marty', 'Affiliation': 'Anesthesia, Clinique Medipole Garonne, Toulouse, France philippemarty@hotmail.com.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Rontes', 'Affiliation': 'Anesthesia, Clinique Medipole Garonne, Toulouse, France.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Chaubard', 'Affiliation': 'Anesthesia, Clinique Medipole Garonne, Toulouse, France.'}, {'ForeName': 'Corine', 'Initials': 'C', 'LastName': 'Vuillaume', 'Affiliation': 'Anesthesia, Clinique Medipole Garonne, Toulouse, France.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Basset', 'Affiliation': 'Anesthesia, Clinique Medipole Garonne, Toulouse, France.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Merouani', 'Affiliation': 'Anesthesia, Clinique Medipole Garonne, Toulouse, France.'}, {'ForeName': 'Constance', 'Initials': 'C', 'LastName': 'Marquis', 'Affiliation': 'Anesthesia, Clinique Medipole Garonne, Toulouse, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'De Lussy', 'Affiliation': 'Anesthesia, Clinique Medipole Garonne, Toulouse, France.'}, {'ForeName': 'Marie-Claude', 'Initials': 'MC', 'LastName': 'Delbos', 'Affiliation': 'Anesthesia, Clinique Medipole Garonne, Toulouse, France.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Casalprim', 'Affiliation': 'Anesthesia, Clinique Medipole Garonne, Toulouse, France.'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Bataille', 'Affiliation': 'Department of Anesthesia and Intensive Care, Narbonne general Hospital, Narbonne, France.'}, {'ForeName': 'Cecile', 'Initials': 'C', 'LastName': 'Naudin', 'Affiliation': 'Clinical Research Department, Ambroise Pare Hospital Group, Neuilly-sur-Seine, France.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Ferre', 'Affiliation': 'Department of Anesthesia, CHU Purpan, Toulouse, France.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Delbos', 'Affiliation': 'Anesthesia, Clinique Medipole Garonne, Toulouse, France.'}]",Regional anesthesia and pain medicine,['10.1136/rapm-2020-101749']
1890,33087494,Neurofilament light chain (NfL) as a biomarker of hereditary transthyretin-mediated amyloidosis.,"OBJECTIVE


To identify changes in the proteome associated with onset and progression of ATTRv amyloidosis, we performed an observational, case-controlled study which compared proteomes of patients with ATTRv amyloidosis and healthy controls.
METHODS


Plasma levels of >1,000 proteins were measured in patients with ATTRv amyloidosis with polyneuropathy who received either placebo or patisiran in the APOLLO study and in healthy controls. The impact of patisiran on the time profile of each protein was determined by linear mixed model at 0, 9, and 18 months. Neurofilament light chain (NfL) was further assessed using an orthogonal quantitative approach.
RESULTS


Levels of 66 proteins were significantly changed with patisiran vs placebo, with NfL change most significant ( p  < 10 -20 ). Analysis of changes in protein levels demonstrated that the proteome of patisiran-treated patients trended toward healthy controls at 18 months. Healthy controls' NfL levels were 4-fold lower than in patients with ATTRv amyloidosis with polyneuropathy (16.3 vs 69.4 pg/mL, effect: -53.1 pg/mL, 95% CI [-60.5 to -45.9]). NfL levels at 18 months increased with placebo (99.5 vs 63.2 pg/mL, 36.3 pg/mL, [16.5-56.1]) and decreased with patisiran treatment (48.8 vs 72.1 pg/mL, -23.3 pg/mL, [-33.4 to -13.1]) from baseline. At 18 months, improvement in modified Neuropathy Impairment Score +7 following patisiran significantly correlated with reduced NfL ( R  = 0.43, [0.29-0.55]).
CONCLUSIONS


Findings suggest NfL may serve as a biomarker of nerve damage and polyneuropathy in ATTRv amyloidosis, may enable earlier diagnosis of patients with ATTRv amyloidosis, and facilitate monitoring of disease progression.
CLASSIFICATION OF EVIDENCE


This study provides Class III evidence that NfL levels may enable earlier diagnosis of polyneuropathy in patients with ATTRv amyloidosis and facilitate monitoring of disease progression.",2020,"Healthy controls' NfL levels were 4-fold lower than in patients with ATTRv amyloidosis with polyneuropathy (16.3 vs 69.4 pg/mL, effect: -53.1 pg/mL, 95% CI [-60.5 to -45.9]).","['patients with ATTRv amyloidosis and healthy controls', 'Plasma levels of >1,000 proteins were measured in patients with ATTRv amyloidosis with polyneuropathy who received either', 'or patisiran in the APOLLO study and in healthy controls']","['Neurofilament light chain (NfL', 'placebo']","['NfL levels', 'protein levels', 'modified Neuropathy Impairment Score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002726', 'cui_str': 'Amyloidosis'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0152025', 'cui_str': 'Polyneuropathy'}, {'cui': 'C3896714', 'cui_str': 'patisiran'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0027834', 'cui_str': 'Neurofilaments'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0027834', 'cui_str': 'Neurofilaments'}, {'cui': 'C1562562', 'cui_str': 'Light chain level'}, {'cui': 'C0428479', 'cui_str': 'Protein level - finding'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",1000.0,0.139476,"Healthy controls' NfL levels were 4-fold lower than in patients with ATTRv amyloidosis with polyneuropathy (16.3 vs 69.4 pg/mL, effect: -53.1 pg/mL, 95% CI [-60.5 to -45.9]).","[{'ForeName': 'Simina', 'Initials': 'S', 'LastName': 'Ticau', 'Affiliation': 'From Alnylam Pharmaceuticals, Cambridge, MA, USA (S.T., G.V.S., S.T., W.L.C., A.C., J.A.G., D.E., E.A., K.F., A.V., P.N.); MRC Centre for Neuromuscular Diseases, UCL Queen Square Institute of Neurology, London, UK (M.M.R.); AP-HP. Université Paris-Saclay, CHU Bicêtre, INSERM U1195, Le Kremlin Bicêtre, France (D.A.); and Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, MD, USA (M.P.).'}, {'ForeName': 'Gautham V', 'Initials': 'GV', 'LastName': 'Sridharan', 'Affiliation': 'From Alnylam Pharmaceuticals, Cambridge, MA, USA (S.T., G.V.S., S.T., W.L.C., A.C., J.A.G., D.E., E.A., K.F., A.V., P.N.); MRC Centre for Neuromuscular Diseases, UCL Queen Square Institute of Neurology, London, UK (M.M.R.); AP-HP. Université Paris-Saclay, CHU Bicêtre, INSERM U1195, Le Kremlin Bicêtre, France (D.A.); and Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, MD, USA (M.P.).'}, {'ForeName': 'Shira', 'Initials': 'S', 'LastName': 'Tsour', 'Affiliation': 'From Alnylam Pharmaceuticals, Cambridge, MA, USA (S.T., G.V.S., S.T., W.L.C., A.C., J.A.G., D.E., E.A., K.F., A.V., P.N.); MRC Centre for Neuromuscular Diseases, UCL Queen Square Institute of Neurology, London, UK (M.M.R.); AP-HP. Université Paris-Saclay, CHU Bicêtre, INSERM U1195, Le Kremlin Bicêtre, France (D.A.); and Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, MD, USA (M.P.).'}, {'ForeName': 'William L', 'Initials': 'WL', 'LastName': 'Cantley', 'Affiliation': 'From Alnylam Pharmaceuticals, Cambridge, MA, USA (S.T., G.V.S., S.T., W.L.C., A.C., J.A.G., D.E., E.A., K.F., A.V., P.N.); MRC Centre for Neuromuscular Diseases, UCL Queen Square Institute of Neurology, London, UK (M.M.R.); AP-HP. Université Paris-Saclay, CHU Bicêtre, INSERM U1195, Le Kremlin Bicêtre, France (D.A.); and Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, MD, USA (M.P.).'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Chan', 'Affiliation': 'From Alnylam Pharmaceuticals, Cambridge, MA, USA (S.T., G.V.S., S.T., W.L.C., A.C., J.A.G., D.E., E.A., K.F., A.V., P.N.); MRC Centre for Neuromuscular Diseases, UCL Queen Square Institute of Neurology, London, UK (M.M.R.); AP-HP. Université Paris-Saclay, CHU Bicêtre, INSERM U1195, Le Kremlin Bicêtre, France (D.A.); and Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, MD, USA (M.P.).'}, {'ForeName': 'Jason A', 'Initials': 'JA', 'LastName': 'Gilbert', 'Affiliation': 'From Alnylam Pharmaceuticals, Cambridge, MA, USA (S.T., G.V.S., S.T., W.L.C., A.C., J.A.G., D.E., E.A., K.F., A.V., P.N.); MRC Centre for Neuromuscular Diseases, UCL Queen Square Institute of Neurology, London, UK (M.M.R.); AP-HP. Université Paris-Saclay, CHU Bicêtre, INSERM U1195, Le Kremlin Bicêtre, France (D.A.); and Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, MD, USA (M.P.).'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Erbe', 'Affiliation': 'From Alnylam Pharmaceuticals, Cambridge, MA, USA (S.T., G.V.S., S.T., W.L.C., A.C., J.A.G., D.E., E.A., K.F., A.V., P.N.); MRC Centre for Neuromuscular Diseases, UCL Queen Square Institute of Neurology, London, UK (M.M.R.); AP-HP. Université Paris-Saclay, CHU Bicêtre, INSERM U1195, Le Kremlin Bicêtre, France (D.A.); and Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, MD, USA (M.P.).'}, {'ForeName': 'Emre', 'Initials': 'E', 'LastName': 'Aldinc', 'Affiliation': 'From Alnylam Pharmaceuticals, Cambridge, MA, USA (S.T., G.V.S., S.T., W.L.C., A.C., J.A.G., D.E., E.A., K.F., A.V., P.N.); MRC Centre for Neuromuscular Diseases, UCL Queen Square Institute of Neurology, London, UK (M.M.R.); AP-HP. Université Paris-Saclay, CHU Bicêtre, INSERM U1195, Le Kremlin Bicêtre, France (D.A.); and Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, MD, USA (M.P.).'}, {'ForeName': 'Mary M', 'Initials': 'MM', 'LastName': 'Reilly', 'Affiliation': 'From Alnylam Pharmaceuticals, Cambridge, MA, USA (S.T., G.V.S., S.T., W.L.C., A.C., J.A.G., D.E., E.A., K.F., A.V., P.N.); MRC Centre for Neuromuscular Diseases, UCL Queen Square Institute of Neurology, London, UK (M.M.R.); AP-HP. Université Paris-Saclay, CHU Bicêtre, INSERM U1195, Le Kremlin Bicêtre, France (D.A.); and Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, MD, USA (M.P.).'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Adams', 'Affiliation': 'From Alnylam Pharmaceuticals, Cambridge, MA, USA (S.T., G.V.S., S.T., W.L.C., A.C., J.A.G., D.E., E.A., K.F., A.V., P.N.); MRC Centre for Neuromuscular Diseases, UCL Queen Square Institute of Neurology, London, UK (M.M.R.); AP-HP. Université Paris-Saclay, CHU Bicêtre, INSERM U1195, Le Kremlin Bicêtre, France (D.A.); and Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, MD, USA (M.P.).'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Polydefkis', 'Affiliation': 'From Alnylam Pharmaceuticals, Cambridge, MA, USA (S.T., G.V.S., S.T., W.L.C., A.C., J.A.G., D.E., E.A., K.F., A.V., P.N.); MRC Centre for Neuromuscular Diseases, UCL Queen Square Institute of Neurology, London, UK (M.M.R.); AP-HP. Université Paris-Saclay, CHU Bicêtre, INSERM U1195, Le Kremlin Bicêtre, France (D.A.); and Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, MD, USA (M.P.).'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Fitzgerald', 'Affiliation': 'From Alnylam Pharmaceuticals, Cambridge, MA, USA (S.T., G.V.S., S.T., W.L.C., A.C., J.A.G., D.E., E.A., K.F., A.V., P.N.); MRC Centre for Neuromuscular Diseases, UCL Queen Square Institute of Neurology, London, UK (M.M.R.); AP-HP. Université Paris-Saclay, CHU Bicêtre, INSERM U1195, Le Kremlin Bicêtre, France (D.A.); and Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, MD, USA (M.P.).'}, {'ForeName': 'Akshay', 'Initials': 'A', 'LastName': 'Vaishnaw', 'Affiliation': 'From Alnylam Pharmaceuticals, Cambridge, MA, USA (S.T., G.V.S., S.T., W.L.C., A.C., J.A.G., D.E., E.A., K.F., A.V., P.N.); MRC Centre for Neuromuscular Diseases, UCL Queen Square Institute of Neurology, London, UK (M.M.R.); AP-HP. Université Paris-Saclay, CHU Bicêtre, INSERM U1195, Le Kremlin Bicêtre, France (D.A.); and Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, MD, USA (M.P.).'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Nioi', 'Affiliation': 'From Alnylam Pharmaceuticals, Cambridge, MA, USA (S.T., G.V.S., S.T., W.L.C., A.C., J.A.G., D.E., E.A., K.F., A.V., P.N.); MRC Centre for Neuromuscular Diseases, UCL Queen Square Institute of Neurology, London, UK (M.M.R.); AP-HP. Université Paris-Saclay, CHU Bicêtre, INSERM U1195, Le Kremlin Bicêtre, France (D.A.); and Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, MD, USA (M.P.). pnioi@alnylam.com.'}]",Neurology,['10.1212/WNL.0000000000011090']
1891,33087584,Music Can Reduce the Need for Pharmacologic Conscious Sedation During Invasive Coronary Angiography.,"OBJECTIVES


Opiates and benzodiazepines are commonly used during invasive coronary angiography (ICA) to address pain and anxiety. In the United States (US), these medications are used in more than 90% of such cases. The utility of these medications during ICA has not been addressed by the scientific societies. The goals of this study were to evaluate the impact of music on the use of opiates and benzodiazepines and levels of pain and anxiety in patients undergoing ICA.
METHODS


In this prospective pilot study, a total of 72 subjects undergoing elective ICA were randomized to receive planned pharmacologic standard conscious sedation (SCS), including opiates and/or benzodiazepines pre-ICA vs music plus opiates and/or benzodiazepines as needed. Pain and anxiety levels, as well as use of SCS medications, were monitored during the periprocedural period.
RESULTS


Baseline characteristics, including rates of anxiety, depression, and other psychiatric disorders, were similar between the SCS and music groups. The levels of pain and anxiety were relatively low and similar between the two cohorts during the peri-ICA period. There was a trend toward less frequent use of SCS medications in the music group (62.2% in the SCS group vs 40.0% in the music group; P=.06) and significantly less use of midazolam per case in the music group (0.68 mg in the SCS group vs 0.37 mg in the music group; P=.048). SCS medication use also differed significantly between the two operators.
CONCLUSIONS


Listening to patient-selected music during the peri-ICA period may reduce the need for pharmacologic conscious sedation without adversely affecting pain and anxiety levels.",2020,There was a trend toward less frequent use of SCS medications in the music group (62.2% in the SCS group vs 40.0% in the music group; P=.06) and significantly less use of midazolam per case in the music group (0.68 mg in the SCS group vs 0.37 mg in the music group; P=.048).,"['72 subjects undergoing elective ICA', 'patients undergoing ICA']","['benzodiazepines', 'planned pharmacologic standard conscious sedation (SCS), including opiates and/or benzodiazepines pre-ICA vs music plus opiates and/or benzodiazepines', 'invasive coronary angiography (ICA', 'SCS', 'midazolam']","['pain and anxiety', 'pain and anxiety levels', 'Pain and anxiety levels', 'SCS medications', 'rates of anxiety, depression, and other psychiatric disorders', 'Pharmacologic Conscious Sedation', 'levels of pain and anxiety']","[{'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0079159', 'cui_str': 'Conscious sedation'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0242401', 'cui_str': 'Opiates'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0079159', 'cui_str': 'Conscious sedation'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",72.0,0.0630958,There was a trend toward less frequent use of SCS medications in the music group (62.2% in the SCS group vs 40.0% in the music group; P=.06) and significantly less use of midazolam per case in the music group (0.68 mg in the SCS group vs 0.37 mg in the music group; P=.048).,"[{'ForeName': 'Ramin', 'Initials': 'R', 'LastName': 'Ebrahimi', 'Affiliation': 'Veterans Affairs Greater Los Angeles Healthcare System, 11301 Wilshire Blvd, mail code 111E, Los Angeles, CA 90073 USA. Ebrahimi@ucla.edu.'}, {'ForeName': 'A Laurie', 'Initials': 'AL', 'LastName': 'Shroyer', 'Affiliation': ''}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Dennis', 'Affiliation': ''}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Currier', 'Affiliation': ''}, {'ForeName': 'Dora', 'Initials': 'D', 'LastName': 'Lendvai Wischik', 'Affiliation': ''}]",The Journal of invasive cardiology,[]
1892,33087595,Can a Chatbot Increase the Motivation to Provide Personal Health Information?,"In healthcare settings, questionnaires are used to collect information from a patient. A standard method for this are paper-based questionnaires, but they are often complex to understand or long and frustrating to fill. To increase motivation, we developed a chatbot-based system Ana that asks questions that are normally asked using paper forms or in face-to-face encounters. Ana has been developed for the specific use case of collecting the music biography in the context of music therapy. In this paper, we compare user motivation, relevance of answers and time needed to answer the questions depending on the data entry method (i.e. app Ana versus paper-based questionnaire). A randomised trial was performed with 26 students of music therapy. The results show that the chatbot is more motivating and answers are given faster than on paper. No differences in answer relevance could be determined between the two means. We conclude that a chatbot could become an additional data entry method for collecting personal health information.",2020,No differences in answer relevance could be determined between the two means.,['26 students of music therapy'],[],[],"[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0026868', 'cui_str': 'Music therapy'}]",[],[],,0.0460109,No differences in answer relevance could be determined between the two means.,"[{'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Denecke', 'Affiliation': 'Bern University of Applied Sciences, Bern, Switzerland.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'May', 'Affiliation': 'Bern University of Applied Sciences, Bern, Switzerland.'}, {'ForeName': 'Annkathrin', 'Initials': 'A', 'LastName': 'Pöpel', 'Affiliation': 'Sanatorium Kilchberg, Zurich, Switzerland.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Lutz Hochreutener', 'Affiliation': 'Zurich University of Arts, Zurich, Switzerland.'}]",Studies in health technology and informatics,['10.3233/SHTI200619']
1893,33085170,"Efficacy and safety of a new hyaluronic acid filler for nasolabial folds: A 52-week, multicenter, randomized, evaluator/subject-blind, split-face study.","BACKGROUND


Hyaluronic acid fillers are known to be effective for correction of nasolabial folds. Recently, a novel biphasic hyaluronic acid filler incorporating lidocaine, DIVAVIVA medium has been introduced.
OBJECTIVES


We compared the efficacy and safety between DIVAVIVA medium and Restylane Perlane Lidocaine for moderate to severe nasolabial folds.
METHODS


This was a multicenter, randomized, evaluator/subject-blind, active-controlled, split-face study. A study 1 evaluated the efficacy and safety until 24 weeks. Extension study, study 2, included subjects who wanted to enroll and evaluated the efficacy and safety until 52 weeks. The Wrinkle Severity Rating Scale (WSRS) score, Global Aesthetic Improvement Scale, and Visual Analogue Scale measuring pain were evaluated. All adverse events were monitored.
RESULTS


The mean change of WSRS at week 24 was -0.61 ± 0.54 in DIVAVIVA medium group and -0.59 ± 0.49 in Restylane Perlane Lidocaine group. The difference between two groups was 0.08, which was lower than noninferior limit. In study 2, the mean change of WSRS score at week 52 from baseline was -0.01 ± 0.62 in DIVAVIVA group, 0.06 ± 0.57 in Restylane Perlane Lidocaine group. The primary and secondary efficacy outcomes were also achieved in study 1 and 2. There was no significant difference in the incidence of adverse events between the two groups.
CONCLUSION


DIVAVIVA medium has comparable efficacy and safety with Restylane Perlane Lidocaine for correction of moderate to severe nasolabial folds.",2020,"The Wrinkle Severity Rating Scale (WSRS) score, Global Aesthetic Improvement Scale, and Visual Analogue Scale measuring pain were evaluated.","['included subjects who wanted to enroll and evaluated the efficacy and safety until 52\xa0weeks', 'nasolabial folds', 'moderate to severe nasolabial folds']","['DIVAVIVA medium and Restylane Perlane Lidocaine', 'Restylane Perlane Lidocaine', 'lidocaine', 'new hyaluronic acid filler', 'Lidocaine']","['mean change of WSRS', 'Wrinkle Severity Rating Scale (WSRS) score, Global Aesthetic Improvement Scale, and Visual Analogue Scale measuring pain', 'efficacy and safety', 'mean change of WSRS score', 'Efficacy and safety', 'incidence of adverse events']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1444647', 'cui_str': 'Wanted'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0221328', 'cui_str': 'Nasolabial sulcus structure'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]","[{'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C3177977', 'cui_str': 'Restylane Perlane'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0729441', 'cui_str': 'Filler'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0037301', 'cui_str': 'Wrinkled skin'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0304328,"The Wrinkle Severity Rating Scale (WSRS) score, Global Aesthetic Improvement Scale, and Visual Analogue Scale measuring pain were evaluated.","[{'ForeName': 'Hye In', 'Initials': 'HI', 'LastName': 'Cheon', 'Affiliation': 'Department of Dermatology, Konkuk University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Jin Hee', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Department of Dermatology, Konkuk University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Beom Joon', 'Initials': 'BJ', 'LastName': 'Kim', 'Affiliation': 'Department of Dermatology, Chung-Ang University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Yang Won', 'Initials': 'YW', 'LastName': 'Lee', 'Affiliation': 'Department of Dermatology, Konkuk University School of Medicine, Seoul, Korea.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13773']
1894,33079754,An Evolutionary Medicine Perspective on Treatment of Pediatric Functional Abdominal Pain.,"In a recent issue, Kovacic et al. analyze data from a randomized sham-controlled trial and show that pretreatment vagal efficiency, an index related to respiratory sinus arrhythmia, is a predictor of pain improvement in adolescents with functional abdominal pain when treated with auricular percutaneous electrical nerve field stimulation. The underlying premise is the polyvagal hypothesis, an explanatory framework for the evolution of the mammalian autonomic nervous system, which proposes that functional gastrointestinal disorders can result from a chronic maladaptive state of autonomic neural control mechanisms after traumatic stress. This is an opportunity for us to stimulate physicians' interest in evolutionary medicine.",2020,"The underlying premise is the polyvagal hypothesis, an explanatory framework for the evolution of the mammalian autonomic nervous system, which proposes that functional gastrointestinal disorders can result from a chronic maladaptive state of autonomic neural control mechanisms after traumatic stress.","['adolescents with functional abdominal pain when treated with auricular percutaneous electrical nerve field stimulation', 'Pediatric Functional Abdominal Pain']",[],[],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1609533', 'cui_str': 'Functional abdominal pain'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1522191', 'cui_str': 'Otic route'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}]",[],[],,0.0257708,"The underlying premise is the polyvagal hypothesis, an explanatory framework for the evolution of the mammalian autonomic nervous system, which proposes that functional gastrointestinal disorders can result from a chronic maladaptive state of autonomic neural control mechanisms after traumatic stress.","[{'ForeName': 'Grigorios I', 'Initials': 'GI', 'LastName': 'Leontiadis', 'Affiliation': 'Division of Gastroenterology and Farncombe Family Digestive Health Research Institute, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'George F', 'Initials': 'GF', 'LastName': 'Longstreth', 'Affiliation': 'Department of Gastroenterology, Kaiser Permanente Southern California, San Diego, California, USA.'}]",The American journal of gastroenterology,['10.14309/ajg.0000000000001024']
1895,33079803,The Effects of an Infant Calming Intervention on Mothers' Parenting Self-Efficacy and Satisfaction During the Postpartum Period: A Randomized Controlled Trial.,"The aim of this study was to evaluate the effects of a behavioral infant calming technique to support mothers' parenting self-efficacy and parenting satisfaction. The methods of this randomized controlled trial are based on the CONSORT guidelines. Data were collected during March 1 to May 20, 2019, from 3 postpartum units in 1 university-level hospital in Finland. A total of 250 mothers agreed to participate, of which 120 were randomly allocated to the intervention group and 130 to the control group. All mothers completed a baseline questionnaire before randomization. Mothers in the intervention group were taught the 5 S's infant calming technique. The control group received standard care. Follow-up data were collected 6 to 8 weeks postpartum. The primary outcome measure was the change in parenting self-efficacy and parenting satisfaction scores over the follow-up period. The intervention group showed significantly larger improvements in parenting self-efficacy scores. There were no statistically significant differences in median improvements in parenting satisfaction. The 5 S's infant calming technique is feasible. These study findings may assist midwifery and neonatal nursing staff to support mothers and families during the postpartum period, whether the infants are fussy or not.",2020,The intervention group showed significantly larger improvements in parenting self-efficacy scores.,"['250 mothers agreed to participate, of which 120 were randomly allocated to the intervention group and 130 to the control group']","['Infant Calming Intervention', 'standard care', 'behavioral infant calming technique']","['median improvements in parenting satisfaction', ""Mothers' Parenting Self-Efficacy and Satisfaction"", 'change in parenting self-efficacy and parenting satisfaction scores', 'parenting self-efficacy scores']","[{'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",250.0,0.0876972,The intervention group showed significantly larger improvements in parenting self-efficacy scores.,"[{'ForeName': 'Elina', 'Initials': 'E', 'LastName': 'Botha', 'Affiliation': 'Faculty of Social Sciences, Health Sciences, Tampere University, Tampere, Finland (Ms Botha, Mr Helminen, and Drs Kaunonen and Joronen); Research, Development and Innovation Centre, Tampere University Hospital, Tampere, Finland (Mr Helminen); General Administration, Pirkanmaa Hospital District, Tampere University, Tampere, Finland (Dr Kaunonen); and School of Nursing Science/NuMIQ Research Unit, North-West University, Potchefstroom, South Africa (Dr Lubbe).'}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Helminen', 'Affiliation': ''}, {'ForeName': 'Marja', 'Initials': 'M', 'LastName': 'Kaunonen', 'Affiliation': ''}, {'ForeName': 'Welma', 'Initials': 'W', 'LastName': 'Lubbe', 'Affiliation': ''}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Joronen', 'Affiliation': ''}]",The Journal of perinatal & neonatal nursing,['10.1097/JPN.0000000000000510']
1896,33079804,The Effects of an Infant Calming Intervention on Mothers' Parenting Self-Efficacy and Satisfaction During the Postpartum Period: A Randomized Controlled Trial.,,2020,,[],['Infant Calming Intervention'],"[""Mothers' Parenting Self-Efficacy and Satisfaction""]",[],"[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",,0.0620798,,[],The Journal of perinatal & neonatal nursing,['10.1097/JPN.0000000000000531']
1897,33079807,Comparing the Analgesic Effects of Four Nonpharmacologic Interventions on Term Newborns Undergoing Heel Lance: A Randomized Controlled Trial.,,2020,,['Term Newborns Undergoing Heel Lance'],['Four Nonpharmacologic Interventions'],[],"[{'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0018870', 'cui_str': 'Heel structure'}, {'cui': 'C0522666', 'cui_str': 'Lance'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.300007,,[],The Journal of perinatal & neonatal nursing,['10.1097/JPN.0000000000000532']
1898,33079877,Arterial Catheters for Early Detection and Treatment of Hypotension During Major Noncardiac Surgery: A Randomized Trial.,"BACKGROUND


Continuous blood pressure monitoring may facilitate early detection and prompt treatment of hypotension. We tested the hypothesis that area under the curve (AUC) mean arterial pressure (MAP) <65 mm Hg is reduced by continuous invasive arterial pressure monitoring.
METHODS


Adults having noncardiac surgery were randomly assigned to continuous invasive arterial pressure or intermittent oscillometric blood pressure monitoring. Arterial catheter pressures were recorded at 1-minute intervals; oscillometric pressures were typically recorded at 5-minute intervals. We estimated the arterial catheter effect on AUC-MAP <65 mm Hg using a multivariable proportional odds model adjusting for imbalanced baseline variables and duration of surgery. Pressures <65 mm Hg were categorized as 0, 1-17, 18-91, and >91 mm Hg × minutes of AUC-MAP <65 mm Hg (ie, no hypotension and 3 equally sized groups of increasing hypotension).
RESULTS


One hundred fifty-two patients were randomly assigned to arterial catheter use and 154 to oscillometric monitoring. For various clinical reasons, 143 patients received an arterial catheter, while 163 were monitored oscillometrically. There were a median [Q1, Q3] of 246 [187, 308] pressure measurements in patients with arterial catheters versus 55 (46, 75) measurements in patients monitored oscillometrically. In the primary intent-to-treat analysis, catheter-based monitoring increased detection of AUC-MAP <65 mm Hg, with an estimated proportional odds ratio (ie, odds of being in a worse hypotension category) of 1.78 (95% confidence interval [CI], 1.18-2.70; P = .006). The result was robust over an as-treated analysis and for sensitivity analyses with thresholds of 60 and 70 mm Hg.
CONCLUSIONS


Intraoperative blood pressure monitoring with arterial catheters detected nearly twice as much hypotension as oscillometric measurements.",2020,"In the primary intent-to-treat analysis, catheter-based monitoring increased detection of AUC-MAP <65 mm Hg, with an estimated proportional odds ratio (ie, odds of being in a worse hypotension category) of 1.78 (95% confidence interval [CI], 1.18-2.70; P = .006).","['Adults having noncardiac surgery', 'One hundred fifty-two patients', '143 patients received an arterial catheter, while 163 were monitored oscillometrically', 'Hypotension During Major Noncardiac Surgery']","['continuous invasive arterial pressure or intermittent oscillometric blood pressure monitoring', 'arterial catheter use and 154 to oscillometric monitoring', 'AUC-MAP']","['hypotension', 'Arterial catheter pressures', 'area under the curve (AUC) mean arterial pressure (MAP']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517573', 'cui_str': '143'}, {'cui': 'C0581447', 'cui_str': 'Arterial catheter'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0428890', 'cui_str': 'Invasive arterial pressure'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0026426', 'cui_str': 'Blood pressure monitoring'}, {'cui': 'C0581447', 'cui_str': 'Arterial catheter'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}]","[{'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0581447', 'cui_str': 'Arterial catheter'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}]",152.0,0.286559,"In the primary intent-to-treat analysis, catheter-based monitoring increased detection of AUC-MAP <65 mm Hg, with an estimated proportional odds ratio (ie, odds of being in a worse hypotension category) of 1.78 (95% confidence interval [CI], 1.18-2.70; P = .006).","[{'ForeName': 'Amanda J', 'Initials': 'AJ', 'LastName': 'Naylor', 'Affiliation': 'From the Departments of Outcomes Research.'}, {'ForeName': 'Daniel I', 'Initials': 'DI', 'LastName': 'Sessler', 'Affiliation': 'From the Departments of Outcomes Research.'}, {'ForeName': 'Kamal', 'Initials': 'K', 'LastName': 'Maheshwari', 'Affiliation': 'From the Departments of Outcomes Research.'}, {'ForeName': 'Ashish K', 'Initials': 'AK', 'LastName': 'Khanna', 'Affiliation': 'From the Departments of Outcomes Research.'}, {'ForeName': 'Dongsheng', 'Initials': 'D', 'LastName': 'Yang', 'Affiliation': 'From the Departments of Outcomes Research.'}, {'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': 'Mascha', 'Affiliation': 'From the Departments of Outcomes Research.'}, {'ForeName': 'Iman', 'Initials': 'I', 'LastName': 'Suleiman', 'Affiliation': 'From the Departments of Outcomes Research.'}, {'ForeName': 'Eric M', 'Initials': 'EM', 'LastName': 'Reville', 'Affiliation': 'From the Departments of Outcomes Research.'}, {'ForeName': 'Devan', 'Initials': 'D', 'LastName': 'Cote', 'Affiliation': 'From the Departments of Outcomes Research.'}, {'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Hutcherson', 'Affiliation': 'From the Departments of Outcomes Research.'}, {'ForeName': 'Bianka M', 'Initials': 'BM', 'LastName': 'Nguyen', 'Affiliation': 'From the Departments of Outcomes Research.'}, {'ForeName': 'Hesham', 'Initials': 'H', 'LastName': 'Elsharkawy', 'Affiliation': 'From the Departments of Outcomes Research.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Kurz', 'Affiliation': 'From the Departments of Outcomes Research.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000004370']
1899,33079883,Comparison of Pupillometry With Surgical Pleth Index Monitoring on Perioperative Opioid Consumption and Nociception During Propofol-Remifentanil Anesthesia: A Prospective Randomized Controlled Trial.,"BACKGROUND


Intraoperative monitoring with pupillometry has shown promising results for nociception/antinociception balance monitoring. However, its benefits in clinical practice remain unproven. The aim of this study was to evaluate the efficacy of intraoperative pupillometry monitoring on intraoperative opioid consumption and postoperative pain compared to surgical pleth index (SPI), another widely investigated monitoring.
METHODS


American Society of Anesthesiologists (ASA) I-II patients scheduled for elective laparoscopic cholecystectomy were included. This prospective, parallel-arm, single-center study was conducted in 2 steps. First, we evaluated the feasibility of using pupillometry and SPI monitoring compared with conventional hemodynamic monitoring. Next, a parallel-arm, double-blind randomized study compared the peak postoperative pain measured with numerical rating scale (NRS) from 0 (no pain) to 10 (extreme pain) as a primary outcome between pupillometry (pupillometry group, n = 43) and SPI monitoring (SPI group, n = 43) using Mann-Whitney U test. Secondary outcomes included intraoperative remifentanil consumption, postoperative opioid responsiveness (a decrease in NRS by ≥1 after fentanyl administrations), number of analgesic administrations, and opioid-related complications.
RESULTS


In the preliminary study (n = 50), remifentanil consumption was less under pupillometry monitoring compared to SPI monitoring, and peak postoperative pain was lower under pupillometry compared to conventional monitoring. In the main study (n = 86), peak postoperative pain and intraoperative remifentanil consumption were lower in the pupillometry group (median [first to third quartile], 5 [4-6]; mean ± standard deviation [SD], 0.078 ± 0.019 μg·kg·minute) compared to the SPI group (7 [5-8] and 0.0130 ± 0.051 μg·kg·minute; P < .001), with the median difference in peak postoperative pain of -1 and its 95% confidence interval between -2 and -0.5. The pupillometry group had better responsiveness to fentanyl (84.6% vs 61.0%; P = .005) and lower number of analgesic administrations (2 [1-2] vs 2 [1-3]; P = .048) compared to the SPI group.
CONCLUSIONS


Intraoperative pupillometry monitoring reduced intraoperative remifentanil consumption and postoperative pain. It may be an alternative option for intraoperative opioid control under general anesthesia in adult patients.",2020,"The pupillometry group had better responsiveness to fentanyl (84.6% vs 61.0%; P = .005) and lower number of analgesic administrations (2 [1-2] vs 2 [1-3]; P = .048) compared to the SPI group.
","['adult patients', 'American Society of Anesthesiologists (ASA']","['surgical pleth index (SPI', 'elective laparoscopic cholecystectomy', 'intraoperative pupillometry monitoring', 'pupillometry and SPI monitoring', 'conventional hemodynamic monitoring', 'Pupillometry With Surgical Pleth Index Monitoring', 'Propofol-Remifentanil Anesthesia']","['better responsiveness to fentanyl', 'intraoperative remifentanil consumption, postoperative opioid responsiveness (a decrease in NRS by ≥1 after fentanyl administrations), number of analgesic administrations, and opioid-related complications', 'Perioperative Opioid Consumption and Nociception', 'intraoperative opioid consumption and postoperative pain', 'peak postoperative pain measured with numerical rating scale (NRS', 'peak postoperative pain and intraoperative remifentanil consumption', 'peak postoperative pain', 'number of analgesic administrations', 'intraoperative remifentanil consumption and postoperative pain']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C4082936', 'cui_str': 'Hemodynamic monitoring'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}]","[{'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0262176', 'cui_str': 'Administration of analgesic'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0234194', 'cui_str': 'Nociperception'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",,0.251762,"The pupillometry group had better responsiveness to fentanyl (84.6% vs 61.0%; P = .005) and lower number of analgesic administrations (2 [1-2] vs 2 [1-3]; P = .048) compared to the SPI group.
","[{'ForeName': 'Jong Hae', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'From the Department of Anesthesiology and Pain Medicine, Daegu Catholic University Medical Center, School of Medicine, Daegu Catholic University, Daegu, Republic of Korea.'}, {'ForeName': 'Eun Kyung', 'Initials': 'EK', 'LastName': 'Jwa', 'Affiliation': 'Division of Hepatobiliary Surgery, Department of Surgery, Daegu Catholic University Medical Center, School of Medicine, Daegu Catholic University, Daegu, Republic of Korea.'}, {'ForeName': 'Youjin', 'Initials': 'Y', 'LastName': 'Choung', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Hanyang University Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Hyo Jin', 'Initials': 'HJ', 'LastName': 'Yeon', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Hanyang University Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Soo Yeon', 'Initials': 'SY', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Hanyang University Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Hanyang University Medical Center, College of Medicine, Hanyang University, Seoul, Republic of Korea.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000004958']
1900,33079965,The effect of etidronate on choroidal neovascular activity in patients with pseudoxanthoma elasticum.,"AIM


To assess the effect of the bisphosphonate etidronate on choroidal neovascular (CNV) activity in patients with pseudoxanthoma elasticum (PXE).
METHODS


This is an ancillary study in a single center, randomized, double-blind placebo-controlled trial (RCT) in which 74 patients with PXE were assigned to either one-year etidronate or placebo treatment. Spectral domain optical coherence tomography (SD-OCT) imaging and color fundus photography were performed every three months for one year and were systematically assessed on signs of CNV activity.
RESULTS


In the etidronate group, 11 (30%) of the patients had CNV activity at baseline, compared to 25 (67%) of the patients in the placebo group (P = 0.005). The proportion of eyes with CNV activity during the study ranged from 18-33% in the etidronate group and 42-56% in the placebo group and no significant difference in improvement or worsening of CNV activity was found (P = 0.168). Using a generalized mixed model for repeated measures, there was a protective effect of etidronate in crude analysis (RR 0.86, 95% CI 0.75-0.98) that disappeared when adjusting for baseline CNV activity (RR 0.97, 95% CI 0.84-1.13).
CONCLUSION


In this post-hoc RCT analysis we did not observe a protecting or deteriorating effect of etidronate on CNV activity in patients with PXE after adjustment for baseline CNV.",2020,The proportion of eyes with CNV activity during the study ranged from 18-33% in the etidronate group and 42-56% in the placebo group and no significant difference in improvement or worsening of CNV activity was found (P = 0.168).,"['patients with pseudoxanthoma elasticum (PXE', 'patients with pseudoxanthoma elasticum', '74 patients with PXE']","['etidronate', 'placebo', 'bisphosphonate etidronate', 'etidronate or placebo']","['CNV activity', 'choroidal neovascular activity', 'improvement or worsening of CNV activity', 'choroidal neovascular (CNV) activity', 'proportion of eyes with CNV activity', 'baseline CNV activity ']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033847', 'cui_str': 'Pseudoxanthoma elasticum'}]","[{'cui': 'C0086268', 'cui_str': 'Etidronate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0012544', 'cui_str': 'Bisphosphonate'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",74.0,0.315344,The proportion of eyes with CNV activity during the study ranged from 18-33% in the etidronate group and 42-56% in the placebo group and no significant difference in improvement or worsening of CNV activity was found (P = 0.168).,"[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Risseeuw', 'Affiliation': 'Department of Ophthalmology, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Redmer', 'Initials': 'R', 'LastName': 'van Leeuwen', 'Affiliation': 'Department of Ophthalmology, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Saskia M', 'Initials': 'SM', 'LastName': 'Imhof', 'Affiliation': 'Department of Ophthalmology, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Pim A', 'Initials': 'PA', 'LastName': 'de Jong', 'Affiliation': 'Department of Radiology and Nuclear Medicine, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Willem P Th M', 'Initials': 'WPTM', 'LastName': 'Mali', 'Affiliation': 'Department of Radiology and Nuclear Medicine, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Wilko', 'Initials': 'W', 'LastName': 'Spiering', 'Affiliation': 'Department of Vascular Medicine, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Jeannette', 'Initials': 'J', 'LastName': 'Ossewaarde-van Norel', 'Affiliation': 'Department of Ophthalmology, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}]",PloS one,['10.1371/journal.pone.0240970']
1901,33079968,Predicting overdose among individuals prescribed opioids using routinely collected healthcare utilization data.,"INTRODUCTION


With increasing rates of opioid overdoses in the US, a surveillance tool to identify high-risk patients may help facilitate early intervention.
OBJECTIVE


To develop an algorithm to predict overdose using routinely-collected healthcare databases.
METHODS


Within a US commercial claims database (2011-2015), patients with ≥1 opioid prescription were identified. Patients were randomly allocated into the training (50%), validation (25%), or test set (25%). For each month of follow-up, pooled logistic regression was used to predict the odds of incident overdose in the next month based on patient history from the preceding 3-6 months (time-updated), using elastic net for variable selection. As secondary analyses, we explored whether using simpler models (few predictors, baseline only) or different analytic methods (random forest, traditional regression) influenced performance.
RESULTS


We identified 5,293,880 individuals prescribed opioids; 2,682 patients (0.05%) had an overdose during follow-up (mean: 17.1 months). On average, patients who overdosed were younger and had more diagnoses and prescriptions. The elastic net model achieved good performance (c-statistic 0.887, 95% CI 0.872-0.902; sensitivity 80.2, specificity 80.1, PPV 0.21, NPV 99.9 at optimal cutpoint). It outperformed simpler models based on few predictors (c-statistic 0.825, 95% CI 0.808-0.843) and baseline predictors only (c-statistic 0.806, 95% CI 0.787-0.26). Different analytic techniques did not substantially influence performance. In the final algorithm based on elastic net, the strongest predictors were age 18-25 years (OR: 2.21), prior suicide attempt (OR: 3.68), opioid dependence (OR: 3.14).
CONCLUSIONS


We demonstrate that sophisticated algorithms using healthcare databases can be predictive of overdose, creating opportunities for active monitoring and early intervention.",2020,"The elastic net model achieved good performance (c-statistic 0.887, 95% CI 0.872-0.902; sensitivity 80.2, specificity 80.1, PPV 0.21, NPV 99.9 at optimal cutpoint).","['5,293,880 individuals prescribed opioids; 2,682 patients (0.05%) had an overdose during follow-up (mean: 17.1 months']",[],[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517411', 'cui_str': '0.05'}, {'cui': 'C0029944', 'cui_str': 'Drug overdose'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",[],[],2682.0,0.0579435,"The elastic net model achieved good performance (c-statistic 0.887, 95% CI 0.872-0.902; sensitivity 80.2, specificity 80.1, PPV 0.21, NPV 99.9 at optimal cutpoint).","[{'ForeName': 'Jenny W', 'Initials': 'JW', 'LastName': 'Sun', 'Affiliation': ""Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, United States of America.""}, {'ForeName': 'Jessica M', 'Initials': 'JM', 'LastName': 'Franklin', 'Affiliation': ""Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, United States of America.""}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Rough', 'Affiliation': ""Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, United States of America.""}, {'ForeName': 'Rishi J', 'Initials': 'RJ', 'LastName': 'Desai', 'Affiliation': ""Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, United States of America.""}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Hernández-Díaz', 'Affiliation': 'Department of Epidemiology, Harvard T. H. Chan School of Public Health, Boston, MA, United States of America.'}, {'ForeName': 'Krista F', 'Initials': 'KF', 'LastName': 'Huybrechts', 'Affiliation': ""Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, United States of America.""}, {'ForeName': 'Brian T', 'Initials': 'BT', 'LastName': 'Bateman', 'Affiliation': ""Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, United States of America.""}]",PloS one,['10.1371/journal.pone.0241083']
1902,33080005,Effect of Tocilizumab vs Standard Care on Clinical Worsening in Patients Hospitalized With COVID-19 Pneumonia: A Randomized Clinical Trial.,"Importance


The coronavirus disease 2019 (COVID-19) pandemic is threatening billions of people worldwide. Tocilizumab has shown promising results in retrospective studies in patients with COVID-19 pneumonia with a good safety profile.
Objective


To evaluate the effect of early tocilizumab administration vs standard therapy in preventing clinical worsening in patients hospitalized with COVID-19 pneumonia.
Design, Setting, and Participants


Prospective, open-label, randomized clinical trial that randomized patients hospitalized between March 31 and June 11, 2020, with COVID-19 pneumonia to receive tocilizumab or standard of care in 24 hospitals in Italy. Cases of COVID-19 were confirmed by polymerase chain reaction method with nasopharyngeal swab. Eligibility criteria included COVID-19 pneumonia documented by radiologic imaging, partial pressure of arterial oxygen to fraction of inspired oxygen (Pao2/Fio2) ratio between 200 and 300 mm Hg, and an inflammatory phenotype defined by fever and elevated C-reactive protein.
Interventions


Patients in the experimental arm received intravenous tocilizumab within 8 hours from randomization (8 mg/kg up to a maximum of 800 mg), followed by a second dose after 12 hours. Patients in the control arm received supportive care following the protocols of each clinical center until clinical worsening and then could receive tocilizumab as a rescue therapy.
Main Outcome and Measures


The primary composite outcome was defined as entry into the intensive care unit with invasive mechanical ventilation, death from all causes, or clinical aggravation documented by the finding of a Pao2/Fio2 ratio less than 150 mm Hg, whichever came first.
Results


A total of 126 patients were randomized (60 to the tocilizumab group; 66 to the control group). The median (interquartile range) age was 60.0 (53.0-72.0) years, and the majority of patients were male (77 of 126, 61.1%). Three patients withdrew from the study, leaving 123 patients available for the intention-to-treat analyses. Seventeen patients of 60 (28.3%) in the tocilizumab arm and 17 of 63 (27.0%) in the standard care group showed clinical worsening within 14 days since randomization (rate ratio, 1.05; 95% CI, 0.59-1.86). Two patients in the experimental group and 1 in the control group died before 30 days from randomization, and 6 and 5 patients were intubated in the 2 groups, respectively. The trial was prematurely interrupted after an interim analysis for futility.
Conclusions and Relevance


In this randomized clinical trial of hospitalized adult patients with COVID-19 pneumonia and Pao2/Fio2 ratio between 200 and 300 mm Hg who received tocilizumab, no benefit on disease progression was observed compared with standard care. Further blinded, placebo-controlled randomized clinical trials are needed to confirm the results and to evaluate possible applications of tocilizumab in different stages of the disease.
Trial Registration


ClinicalTrials.gov Identifier: NCT04346355; EudraCT Identifier: 2020-001386-37.",2020,"Seventeen patients of 60 (28.3%) in the tocilizumab arm and 17 of 63 (27.0%) in the standard care group showed clinical worsening within 14 days since randomization (rate ratio, 1.05; 95% CI, 0.59-1.86).","['patients with COVID-19 pneumonia with a good safety profile', 'Eligibility criteria included COVID-19 pneumonia documented by radiologic imaging, partial pressure of arterial oxygen to fraction of inspired oxygen (Pao2/Fio2) ratio between 200 and 300 mm Hg, and an inflammatory phenotype defined by fever and elevated C-reactive protein', 'Patients Hospitalized With COVID-19 Pneumonia', 'patients hospitalized with COVID-19 pneumonia', 'A total of 126 patients', 'or standard of care in 24 hospitals in Italy', 'hospitalized adult patients with COVID-19 pneumonia and Pao2/Fio2 ratio between 200 and 300 mm Hg who received', 'patients hospitalized between March 31 and June 11, 2020, with COVID-19 pneumonia to receive']","['intravenous tocilizumab', 'supportive care', 'tocilizumab administration vs standard therapy', 'Tocilizumab vs Standard Care', 'Tocilizumab', 'placebo', 'tocilizumab']","['disease progression', 'entry into the intensive care unit with invasive mechanical ventilation, death from all causes, or clinical aggravation documented by the finding of a Pao2/Fio2 ratio less', 'clinical worsening']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0034599', 'cui_str': 'Radiology - specialty'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0030604', 'cui_str': 'Partial pressure'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0428167', 'cui_str': 'Fraction of inspired oxygen'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0031437', 'cui_str': 'Phenotype'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0742906', 'cui_str': 'Elevated C-reactive protein'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C1609165', 'cui_str': 'tocilizumab'}, {'cui': 'C0344211', 'cui_str': 'Support'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",126.0,0.323061,"Seventeen patients of 60 (28.3%) in the tocilizumab arm and 17 of 63 (27.0%) in the standard care group showed clinical worsening within 14 days since randomization (rate ratio, 1.05; 95% CI, 0.59-1.86).","[{'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Salvarani', 'Affiliation': 'SOC Reumatologia, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Dolci', 'Affiliation': 'Unità di Malattie Infettive, Università degli Studi di Modena e Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Massari', 'Affiliation': 'SOC Malattie Infettive, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Domenico Franco', 'Initials': 'DF', 'LastName': 'Merlo', 'Affiliation': 'SC Infrastruttura Ricerca e Statistica, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Silvio', 'Initials': 'S', 'LastName': 'Cavuto', 'Affiliation': 'SC Infrastruttura Ricerca e Statistica, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Luisa', 'Initials': 'L', 'LastName': 'Savoldi', 'Affiliation': 'SC Infrastruttura Ricerca e Statistica, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Bruzzi', 'Affiliation': 'SC Epidemiologia Clinica, IRCCS Ospedale Policlinico San Martino, Genova, Italy.'}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'Boni', 'Affiliation': 'SOC Internistica Multidisciplinare, Ospedale Civile Guastalla, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Braglia', 'Affiliation': 'SC Infrastruttura Ricerca e Statistica, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Caterina', 'Initials': 'C', 'LastName': 'Turrà', 'Affiliation': 'SOC Farmacia, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Pier Ferruccio', 'Initials': 'PF', 'LastName': 'Ballerini', 'Affiliation': 'UOC Medicina Generale Ospedale di Vittorio Veneto, Treviso, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Sciascia', 'Affiliation': 'UOC Medicina Generale Ospedale di Vittorio Veneto, Treviso, Italy.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Zammarchi', 'Affiliation': 'Dipartimento di Medicina Sperimentale e Clinica, Università degli Studi di Firenze, SOD Malattie infettive e tropicali, AOU Careggi, Firenze, Italy.'}, {'ForeName': 'Ombretta', 'Initials': 'O', 'LastName': 'Para', 'Affiliation': 'Medicina Interna 1, Dipartimento Emergenza ed Accettazione, AOU Careggi, Firenze, Italy.'}, {'ForeName': 'Pier Giorgio', 'Initials': 'PG', 'LastName': 'Scotton', 'Affiliation': ""UO di Malattie Infettive, Ospedale Regionale Ca' Foncello di Treviso, Treviso, Italy.""}, {'ForeName': 'Walter Omar', 'Initials': 'WO', 'LastName': 'Inojosa', 'Affiliation': ""UO di Malattie Infettive, Ospedale Regionale Ca' Foncello di Treviso, Treviso, Italy.""}, {'ForeName': 'Viviana', 'Initials': 'V', 'LastName': 'Ravagnani', 'Affiliation': 'SSD Centro DH Allergologia e Immunologia Clinica, ASST-Mantova, Mantva, Italy.'}, {'ForeName': 'Nicola Duccio', 'Initials': 'ND', 'LastName': 'Salerno', 'Affiliation': 'UOC Malattie Infettive e Tropicali, AOUI di Verona, Verona, Italy.'}, {'ForeName': 'Pier Paolo', 'Initials': 'PP', 'LastName': 'Sainaghi', 'Affiliation': 'SS Reumatologia, SC Medicina Interna, DIMET, Università del Piemonte Orientale e AOU Maggiore della Carità di Novara.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Brignone', 'Affiliation': 'Reumatologia, Medicina Interna, Ospedale S. Andrea, La Spezia, Italy.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Codeluppi', 'Affiliation': 'UOC Malattie Infettive, AUSL di Piacenza, Piacenza, Italy.'}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': 'Teopompi', 'Affiliation': 'SOC Internistica Multidisciplinare, Ospedale Civile Guastalla, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Milesi', 'Affiliation': 'Unità di malattie Infettive, ASST di Cremona, Cremona, Italy.'}, {'ForeName': 'Perla', 'Initials': 'P', 'LastName': 'Bertomoro', 'Affiliation': 'UOC Medicina Generale, ULSS6 Euganea Ospedali Riuniti Padova Sud, Padova, Italy.'}, {'ForeName': 'Norbiato', 'Initials': 'N', 'LastName': 'Claudio', 'Affiliation': 'SC Medicina Interna, AO Ordine Mauriziano, Torino, Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Salio', 'Affiliation': ""SC Malattie dell'Apparato Respiratorio, AO SS. Antonio e Biagio e C. Arrigo, Alessandria, Italy.""}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Falcone', 'Affiliation': 'Unità di Malattie Infettive, Dipartimento di Medicina Clinica e Sperimentale, Università di Pisa, Pisa, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Cenderello', 'Affiliation': 'SC Malattie Infettive, ASL1 Imperia, Impersia, Italy.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Donghi', 'Affiliation': 'UO Malattie Infettive ed Epatologia, AOU Parma, Parma, Italy.'}, {'ForeName': 'Valerio', 'Initials': 'V', 'LastName': 'Del Bono', 'Affiliation': 'Malattie Infettive e Tropicali, AO S. Croce e Carle, Cuneo, Italy.'}, {'ForeName': 'Paolo Luigi', 'Initials': 'PL', 'LastName': 'Colombelli', 'Affiliation': 'UO Medicina, Ospedale di Treviglio, ASST Bergamo Ovest, Bergamo, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Angheben', 'Affiliation': 'Dipartimento di Malattie Infettive, Tropicali e Microbiologia, IRCCS Ospedale Sacro Cuore-Don Calabria, Negrar di Valpolicella, Verona, Italy.'}, {'ForeName': 'Angelina', 'Initials': 'A', 'LastName': 'Passaro', 'Affiliation': 'Medicina Interna Universitaria, AOU Ferrara, Ferrara, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Secondo', 'Affiliation': 'Medicina Interna, Ospedale Evangelico, Genoa, Italy.'}, {'ForeName': 'Renato', 'Initials': 'R', 'LastName': 'Pascale', 'Affiliation': 'UO Malattie Infettive, Dipartimento di scienze mediche e chirurgiche, Università di Bologna, Bologna, Italy.'}, {'ForeName': 'Ilaria', 'Initials': 'I', 'LastName': 'Piazza', 'Affiliation': 'UOC Medicina Interna, AUSSS3 Serenissima, Dolo, Venezia, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Facciolongo', 'Affiliation': 'SOC Pneumologia, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Costantini', 'Affiliation': 'Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA internal medicine,['10.1001/jamainternmed.2020.6615']
1903,33080012,Effect of Therapeutic Hypothermia on the Outcome in Term Neonates with Hypoxic Ischemic Encephalopathy-A Randomized Controlled Trial.,"OBJECTIVE


To assess the effect of therapeutic hypothermia on the outcome in term neonates with hypoxic ischemic encephalopathy (HIE).
METHODS


A randomized controlled trial was conducted in a tertiary care teaching hospital in south India. Term infants with moderate to severe HIE were randomized to be treated with normothermia or hypothermia. Mortality, neurological abnormality or normal outcome was recorded at hospital discharge or 28 days of age, whichever was earlier, and at 18 months of age.
RESULTS


The baseline maternal and neonatal characteristics in the two groups were similar. The 78 infants in the hypothermia group had more normal survivors at discharge (38%) than the 84 infants in the normothermia group (30%), ratio 1.29 (95% confidence interval 0.84-1.99), and at 18 months of age (65% vs. 42%), ratio 1.54 (1.13-2.10). When these results were combined with those of a previous randomized trial in the same neonatal unit, there were significantly more normal survivors with hypothermia compared to normothermia at discharge, ratio 1.49 (1.18-1.88) and at 6-18 months of age, ratio 1.37 (1.17-1.60).
CONCLUSION


In term infants with HIE, therapeutic hypothermia reduced mortality and neurological abnormalities, and resulted in more normal survivors.
LAY SUMMARY


Babies who do not breathe immediately after they are born are likely to die or have brain damage. Previous studies have suggested that cooling these babies after birth might reduce the number who die or have brain damage. In this resource-limited setting, babies who were cooled were less likely to die or survive with brain damage.",2020,"The 78 infants in the hypothermia group had more normal survivors at discharge (38%) than the 84 infants in the normothermia group (30%), ratio 1.29","['Term Neonates with Hypoxic Ischemic Encephalopathy', 'Term infants with moderate to severe HIE', 'term neonates with hypoxic ischemic encephalopathy (HIE', 'tertiary care teaching hospital in south India']","['therapeutic hypothermia', 'normothermia or hypothermia', 'Therapeutic Hypothermia']","['Mortality, neurological abnormality or normal outcome', 'normal survivors at discharge', 'mortality and neurological abnormalities', 'normal survivors with hypothermia', 'baseline maternal and neonatal characteristics']","[{'cui': 'C4551581', 'cui_str': 'Term baby'}, {'cui': 'C0752304', 'cui_str': 'Hypoxic ischemic encephalopathy'}, {'cui': 'C0456128', 'cui_str': 'Term infant'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0021201', 'cui_str': 'India'}]","[{'cui': 'C0020674', 'cui_str': 'Induction of hypothermia'}, {'cui': 'C0445103', 'cui_str': 'Normothermia'}, {'cui': 'C0020672', 'cui_str': 'Hypothermia'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0497552', 'cui_str': 'Congenital anomaly of nervous system'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C3871203', 'cui_str': 'At discharge'}, {'cui': 'C0020672', 'cui_str': 'Hypothermia'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}]",,0.192373,"The 78 infants in the hypothermia group had more normal survivors at discharge (38%) than the 84 infants in the normothermia group (30%), ratio 1.29","[{'ForeName': 'R Christina', 'Initials': 'RC', 'LastName': 'Catherine', 'Affiliation': 'Department of Neonatology, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry 605006, India.'}, {'ForeName': 'Vishnu Bhat', 'Initials': 'VB', 'LastName': 'Ballambattu', 'Affiliation': 'Pediatrics and Neonatology, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry 605006, India.'}, {'ForeName': 'Bethou', 'Initials': 'B', 'LastName': 'Adhisivam', 'Affiliation': 'Department of Neonatology, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry 605006, India.'}, {'ForeName': 'Shruthi K', 'Initials': 'SK', 'LastName': 'Bharadwaj', 'Affiliation': 'Department of Neonatology, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry 605006, India.'}, {'ForeName': 'Chinnakali', 'Initials': 'C', 'LastName': 'Palanivel', 'Affiliation': 'Department of Preventive & Social Medicine, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry 605006, India.'}]",Journal of tropical pediatrics,['10.1093/tropej/fmaa073']
1904,33080017,Effect of Tocilizumab vs Usual Care in Adults Hospitalized With COVID-19 and Moderate or Severe Pneumonia: A Randomized Clinical Trial.,"Importance


Severe pneumonia with hyperinflammation and elevated interleukin-6 is a common presentation of coronavirus disease 2019 (COVID-19).
Objective


To determine whether tocilizumab (TCZ) improves outcomes of patients hospitalized with moderate-to-severe COVID-19 pneumonia.
Design, Setting, and Particpants


This cohort-embedded, investigator-initiated, multicenter, open-label, bayesian randomized clinical trial investigating patients with COVID-19 and moderate or severe pneumonia requiring at least 3 L/min of oxygen but without ventilation or admission to the intensive care unit was conducted between March 31, 2020, to April 18, 2020, with follow-up through 28 days. Patients were recruited from 9 university hospitals in France. Analyses were performed on an intention-to-treat basis with no correction for multiplicity for secondary outcomes.
Interventions


Patients were randomly assigned to receive TCZ, 8 mg/kg, intravenously plus usual care on day 1 and on day 3 if clinically indicated (TCZ group) or to receive usual care alone (UC group). Usual care included antibiotic agents, antiviral agents, corticosteroids, vasopressor support, and anticoagulants.
Main Outcomes and Measures


Primary outcomes were scores higher than 5 on the World Health Organization 10-point Clinical Progression Scale (WHO-CPS) on day 4 and survival without need of ventilation (including noninvasive ventilation) at day 14. Secondary outcomes were clinical status assessed with the WHO-CPS scores at day 7 and day 14, overall survival, time to discharge, time to oxygen supply independency, biological factors such as C-reactive protein level, and adverse events.
Results


Of 131 patients, 64 patients were randomly assigned to the TCZ group and 67 to UC group; 1 patient in the TCZ group withdrew consent and was not included in the analysis. Of the 130 patients, 42 were women (32%), and median (interquartile range) age was 64 (57.1-74.3) years. In the TCZ group, 12 patients had a WHO-CPS score greater than 5 at day 4 vs 19 in the UC group (median posterior absolute risk difference [ARD] -9.0%; 90% credible interval [CrI], -21.0 to 3.1), with a posterior probability of negative ARD of 89.0% not achieving the 95% predefined efficacy threshold. At day 14, 12% (95% CI -28% to 4%) fewer patients needed noninvasive ventilation (NIV) or mechanical ventilation (MV) or died in the TCZ group than in the UC group (24% vs 36%, median posterior hazard ratio [HR] 0.58; 90% CrI, 0.33-1.00), with a posterior probability of HR less than 1 of 95.0%, achieving the predefined efficacy threshold. The HR for MV or death was 0.58 (90% CrI, 0.30 to 1.09). At day 28, 7 patients had died in the TCZ group and 8 in the UC group (adjusted HR, 0.92; 95% CI 0.33-2.53). Serious adverse events occurred in 20 (32%) patients in the TCZ group and 29 (43%) in the UC group (P = .21).
Conclusions and Relevance


In this randomized clinical trial of patients with COVID-19 and pneumonia requiring oxygen support but not admitted to the intensive care unit, TCZ did not reduce WHO-CPS scores lower than 5 at day 4 but might have reduced the risk of NIV, MV, or death by day 14. No difference on day 28 mortality was found. Further studies are necessary for confirming these preliminary results.
Trial Registration


ClinicalTrials.gov Identifier: NCT04331808.",2020,"At day 14, 12% (95% CI -28% to 4%) fewer patients needed noninvasive ventilation (NIV) or mechanical ventilation (MV) or died in the TCZ group than in the UC group (24% vs 36%, median posterior hazard ratio [HR] 0.58; 90% CrI, 0.33-1.00), with a posterior probability of HR less than 1 of 95.0%, achieving the predefined efficacy threshold.","['130 patients, 42 were women (32%), and median (interquartile range) age was 64 (57.1-74.3) years', 'patients hospitalized with moderate-to-severe COVID-19 pneumonia', '64 patients', '131 patients', 'patients with COVID-19 and pneumonia requiring oxygen support but not admitted to the intensive care unit', 'Adults Hospitalized With COVID-19 and Moderate or Severe Pneumonia', 'Patients were recruited from 9 university hospitals in France', 'patients with COVID-19 and moderate or severe pneumonia requiring at least 3 L/min of oxygen but without ventilation or admission to the intensive care unit was conducted between March 31, 2020, to April 18, 2020, with follow-up through 28 days']","['antibiotic agents, antiviral agents, corticosteroids, vasopressor support, and anticoagulants', 'Tocilizumab vs Usual Care', 'TCZ', 'tocilizumab (TCZ', 'TCZ, 8 mg/kg, intravenously plus usual care on day 1 and on day 3 if clinically indicated (TCZ group) or to receive usual care alone (UC group']","['overall survival, time to discharge, time to oxygen supply independency, biological factors such as C-reactive protein level, and adverse events', 'HR for MV or death', 'WHO-CPS scores', 'day 28 mortality', 'clinical status assessed with the WHO-CPS scores', 'Serious adverse events', 'posterior probability of negative ARD', 'posterior probability of HR less', 'risk of NIV, MV, or death', 'scores higher than 5 on the World Health Organization 10-point Clinical Progression Scale (WHO-CPS) on day 4 and survival without need of ventilation (including noninvasive ventilation', 'noninvasive ventilation (NIV) or mechanical ventilation (MV) or died', 'WHO-CPS score']","[{'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0439393', 'cui_str': 'L/min'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0003451', 'cui_str': 'Antiviral'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0042397', 'cui_str': 'Vasoconstrictor agent'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}, {'cui': 'C1609165', 'cui_str': 'tocilizumab'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0429622', 'cui_str': 'Oxygen delivery'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0449440', 'cui_str': 'Clinical status'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0751673', 'cui_str': 'Nipah virus'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}]",64.0,0.173704,"At day 14, 12% (95% CI -28% to 4%) fewer patients needed noninvasive ventilation (NIV) or mechanical ventilation (MV) or died in the TCZ group than in the UC group (24% vs 36%, median posterior hazard ratio [HR] 0.58; 90% CrI, 0.33-1.00), with a posterior probability of HR less than 1 of 95.0%, achieving the predefined efficacy threshold.","[{'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Hermine', 'Affiliation': 'Department of Hematology, Hôpital Necker, Assistance Publique - Hôpitaux de Paris, France.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Mariette', 'Affiliation': 'Department of Rheumatology, Hôpital Bicêtre, Assistance Publique-Hôpitaux de Paris, France.'}, {'ForeName': 'Pierre-Louis', 'Initials': 'PL', 'LastName': 'Tharaux', 'Affiliation': 'Paris Cardiovascular Center-PARCC, Université de Paris, INSERM, F-75015 Paris, France.'}, {'ForeName': 'Matthieu', 'Initials': 'M', 'LastName': 'Resche-Rigon', 'Affiliation': 'Université de Paris, ECSTRRA Team-CRESS-UMR 1153, INSERM, 75010, Paris, France.'}, {'ForeName': 'Raphaël', 'Initials': 'R', 'LastName': 'Porcher', 'Affiliation': 'Université de Paris, Centre of Research Epidemiology and Statistics (CRESS), INSERM U1153, Paris, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Ravaud', 'Affiliation': 'Université de Paris, Centre of Research Epidemiology and Statistics (CRESS), INSERM U1153, Paris, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA internal medicine,['10.1001/jamainternmed.2020.6820']
1905,33080378,Study protocol for a randomized controlled trial of mindfulness-based relapse prevention for opioid use disorders.,"The opioid misuse epidemic has reached a crisis level in the United States. Though mindfulness-based relapse prevention (MBRP) has been shown as effective in treating substance use disorders, there is limited research on its application to opioid use disorders specifically, and there is a need to understand the underlying mechanisms. This paper outlines a protocol for a randomized controlled trial of MBRP for opioid use disorders. MBRP is a group aftercare program that integrates mindfulness skills training with cognitive-behavioral relapse prevention strategies. We will recruit 240 participants who have completed opioid use disorder treatment, and randomize them to an 8-week MBRP group intervention or treatment as usual (TAU) control group. The TAU control group will complete the intervention after 8 weeks. Assessments will take place at baseline, 8 weeks, and 16 weeks. The primary outcome is frequency of opioid use. The secondary outcomes include craving and withdrawal symptoms, time to first opioid use, adherence to medication-assisted treatment plans, perceived stress, quality of life, posttraumatic stress symptoms, and chronic pain. We will also examine the following potential moderators and correlates of intervention outcomes: comorbid diagnoses, life events history, and MBRP intervention adherence. In addition, we will examine the following mediators of intervention outcome: mindfulness skills, emotion regulation skills, executive functioning skills, savoring, and positive and negative affect. This study will contribute to the evidence base regarding MBRP's efficacy in reducing opioid use, as well as contribute to the understanding of the causal mechanisms and factors that modify treatment outcome for MBRP for substance use disorders.",2020,"The secondary outcomes include craving and withdrawal symptoms, time to first opioid use, adherence to medication-assisted treatment plans, perceived stress, quality of life, posttraumatic stress symptoms, and chronic pain.","['240 participants who have completed opioid use disorder treatment, and randomize them to an 8-week']","['MBRP', 'mindfulness-based relapse prevention (MBRP', 'MBRP group intervention or treatment as usual (TAU) control group']","['craving and withdrawal symptoms, time to first opioid use, adherence to medication-assisted treatment plans, perceived stress, quality of life, posttraumatic stress symptoms, and chronic pain', 'frequency of opioid use', 'emotion regulation skills, executive functioning skills, savoring, and positive and negative affect']","[{'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0679867', 'cui_str': 'Relapse prevention'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0087169', 'cui_str': 'Withdrawal symptom'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0521991', 'cui_str': 'Symptoms of stress'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001721', 'cui_str': 'Affect'}]",240.0,0.0377418,"The secondary outcomes include craving and withdrawal symptoms, time to first opioid use, adherence to medication-assisted treatment plans, perceived stress, quality of life, posttraumatic stress symptoms, and chronic pain.","[{'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Zinzow', 'Affiliation': 'Department of Psychology, Clemson University, Clemson, SC 29634, USA. Electronic address: hzinzow@clemson.edu.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Shi', 'Affiliation': 'Department of Public Health Sciences, Clemson University, 500 Edwards Hall, Clemson, SC 29634, USA.'}, {'ForeName': 'Lior', 'Initials': 'L', 'LastName': 'Rennert', 'Affiliation': 'Department of Public Health Sciences, Clemson University, 500 Edwards Hall, Clemson, SC 29634, USA.'}, {'ForeName': 'Liwei', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Epidemiology, University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Snehal', 'Initials': 'S', 'LastName': 'Lopes', 'Affiliation': 'Department of Public Health Sciences, Clemson University, 500 Edwards Hall, Clemson, SC 29634, USA.'}, {'ForeName': 'Lingling', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'College of Nursing and Health Sciences, University of Massachusetts Boston, Boston, MA, USA.'}, {'ForeName': 'Karyn', 'Initials': 'K', 'LastName': 'Jones', 'Affiliation': 'Department of Public Health Sciences, Clemson University, 500 Edwards Hall, Clemson, SC 29634, USA.'}, {'ForeName': 'Meenu', 'Initials': 'M', 'LastName': 'Jindal', 'Affiliation': 'Department of Internal Medicine, Prisma Health System, 701 Grove Road, Greenville, SC, 29605, USA. Electronic address: mjindal@ghs.org.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Stam', 'Affiliation': 'Office of Sponsored Programs, Prisma Health System. Electronic address: Claire.Stam@PrismaHealth.org.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Mclain', 'Affiliation': 'The Phoenix Center, 1400 Cleveland St., Greenville, SC 29602, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106182']
1906,33080379,Decídetexto: Mobile cessation support for latino smokers. study protocol for a randomized clinical trial.,"INTRODUCTION


Latinos, the largest minority group in the U.S., experience tobacco-related disparities, including limited access to cessation resources. Evidence supports the efficacy of mobile interventions for smoking cessation, which may be greater among Latinos, the highest users of text messaging.
OBJECTIVES


To describe the methodology of a randomized clinical trial to evaluate the impact of Decídetexto, a culturally appropriate mobile smoking cessation intervention versus standard care on smoking abstinence (cotinine-verified 7-day point prevalence abstinence) at Month 6 among Latino smokers.
METHODS


Latino smokers (N = 618) will be randomized to one of two conditions: 1) Decídetexto or 2) standard of care. Decídetexto is a mobile smoking cessation intervention (available in English and Spanish) that incorporates 3 integrated components: 1) a tablet-based software that collects smoking-related information to develop an individualized quit plan, 2) a 24-week text messaging counseling program with interactive capabilities, and 3) pharmacotherapy support. Decídetexto follows the Social Cognitive Theory as theoretical framework. Standard of care consists of printed smoking cessation materials along with referral to telephone quitline. Participants in both groups are given access to free pharmacotherapy (nicotine patches or gum) by calling study phone number. Promotores de Salud will rely on community-based approaches and clinical settings to recruit smokers into the study. All participants will complete follow-up assessments at Week 12 and Month 6.
DISCUSSION


If successful, Decídetexto will be ready to be implemented in different community- and clinic-based settings to reduce tobacco-related disparities.",2020,"Evidence supports the efficacy of mobile interventions for smoking cessation, which may be greater among Latinos, the highest users of text messaging.
","['Latino smokers', 'latino smokers', 'Latino smokers (N\u202f=\u202f618']","['Decídetexto or 2) standard of care', 'Decídetexto', 'pharmacotherapy (nicotine patches or gum', 'Decídetexto, a culturally appropriate mobile smoking cessation intervention versus standard care on smoking abstinence (cotinine-verified 7-day point prevalence abstinence']",[],"[{'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0358855', 'cui_str': 'Nicotine Transdermal Patch'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C1692317', 'cui_str': 'Smoking cessation assistance'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0010194', 'cui_str': 'Cotinine'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}]",[],618.0,0.0411656,"Evidence supports the efficacy of mobile interventions for smoking cessation, which may be greater among Latinos, the highest users of text messaging.
","[{'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Cartujano-Barrera', 'Affiliation': 'James P. Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, NY, United States of America. Electronic address: fco_Carbar@hotmail.com.'}, {'ForeName': 'Evelyn', 'Initials': 'E', 'LastName': 'Arana-Chicas', 'Affiliation': 'James P. Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, NY, United States of America.'}, {'ForeName': 'Delwyn', 'Initials': 'D', 'LastName': 'Catley', 'Affiliation': ""Center for Children's Healthy Lifestyles & Nutrition, Children's Mercy Kansas City, Kansas City, MO, United States of America.""}, {'ForeName': 'Lisa Sanderson', 'Initials': 'LS', 'LastName': 'Cox', 'Affiliation': 'Department of Population Health, University of Kansas Medical Center, Kansas City, KS, United States of America.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Diaz', 'Affiliation': 'Department of Biostatistics, University of Kansas Medical Center, Kansas City, KS, United States of America.'}, {'ForeName': 'Edward F', 'Initials': 'EF', 'LastName': 'Ellerbeck', 'Affiliation': 'Department of Population Health, University of Kansas Medical Center, Kansas City, KS, United States of America.'}, {'ForeName': 'Kristi D', 'Initials': 'KD', 'LastName': 'Graves', 'Affiliation': 'Department of Oncology, Georgetown University, Washington, D.C., United States of America.'}, {'ForeName': 'Chinwe', 'Initials': 'C', 'LastName': 'Ogedegbe', 'Affiliation': 'Emergency and Trauma Center, Hackensack University Medical Center, Hackensack, NJ, United States of America.'}, {'ForeName': 'Ana Paula', 'Initials': 'AP', 'LastName': 'Cupertino', 'Affiliation': 'James P. Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, NY, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106188']
1907,33080380,Effectiveness and cost-effectiveness of rubber band ligation versus sutured mucopexy versus haemorrhoidectomy in patients with recurrent haemorrhoidal disease (Napoleon trial): Study protocol for a multicentre randomized controlled trial.,"BACKGROUND


Currently, there is no consensus regarding the best treatment option in recurrent haemorrhoidal disease (HD), due to a lack of solid evidence. The Napoleon trial aims to provide high-level evidence on the comparative effectiveness and cost-effectiveness of repeat rubber band ligation (RBL) versus sutured mucopexy versus haemorrhoidectomy in patients with recurrent HD.
METHODS


This is a multicentre randomized controlled trial. Patients with recurrent HD grade II and III, ≥18 years of age and who had at least two RBL treatments in the last three years are eligible for inclusion. Exclusion criteria include previous rectal or anal surgery, rectal radiation, pre-existing sphincter injury or otherwise pathologies of the colon and rectum, pregnancy, presence of hypercoagulability disorders, and medically unfit for surgery (ASA > III). Between June 2020 and May 2022, 558 patients will be randomized to receive either: (1) RBL, (2) sutured mucopexy, or (3) haemorrhoidectomy. The primary outcomes are recurrence after 52 weeks and patient-reported symptoms measured by the PROM-HISS. Secondary outcomes are impact on daily life, treatment satisfaction, early and late complication rates, health-related quality of life, costs and cost-effectiveness, and budget impact. Cost-effectiveness will be expressed in societal costs per Quality Adjusted Life Year (QALY) (based on EQ-5D-5L), and healthcare costs per recurrence avoided.
DISCUSSION


The best treatment option for recurrent HD remains unknown. The comparison of three generally accepted treatment strategies in a randomized controlled trial will provide high-level evidence on the most (cost-) effective treatment.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT04101773.",2020,"Secondary outcomes are impact on daily life, treatment satisfaction, early and late complication rates, health-related quality of life, costs and cost-effectiveness, and budget impact.","['Between June 2020 and May 2022, 558 patients', 'patients with recurrent haemorrhoidal disease (Napoleon trial', 'patients with recurrent HD', 'Patients with recurrent HD grade II and III, ≥18\u202fyears of age and who had at least two RBL treatments in the last three years are eligible for inclusion']","['repeat rubber band ligation (RBL) versus sutured mucopexy versus haemorrhoidectomy', 'RBL, (2) sutured mucopexy, or (3) haemorrhoidectomy', 'rubber band ligation versus sutured mucopexy versus haemorrhoidectomy']","['recurrence after 52\u202fweeks and patient-reported symptoms', 'daily life, treatment satisfaction, early and late complication rates, health-related quality of life, costs and cost-effectiveness, and budget impact', 'Cost-effectiveness', 'Effectiveness and cost-effectiveness']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0221839', 'cui_str': 'Orthodontic band, elastic'}, {'cui': 'C0023690', 'cui_str': 'Ligation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}]","[{'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0221839', 'cui_str': 'Orthodontic band, elastic'}, {'cui': 'C0023690', 'cui_str': 'Ligation'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0019108', 'cui_str': 'Hemorrhoidectomy'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0006347', 'cui_str': 'Budgets'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",558.0,0.219787,"Secondary outcomes are impact on daily life, treatment satisfaction, early and late complication rates, health-related quality of life, costs and cost-effectiveness, and budget impact.","[{'ForeName': 'Sara Z', 'Initials': 'SZ', 'LastName': 'Kuiper', 'Affiliation': 'Department of Surgery, Maastricht University, School of Nutrition and Translational Research in Metabolism (NUTRIM), Universiteitssingel 50, 6229, ER, Maastricht, the Netherlands. Electronic address: s.kuiper@maastrichtuniversity.nl.'}, {'ForeName': 'Carmen D', 'Initials': 'CD', 'LastName': 'Dirksen', 'Affiliation': 'Department of Clinical Epidemiology and Medical Technology, Care and Public Health Research Institute (CAPHRI), Maastricht University Medical Centre, Oxfordlaan 10, 6202, AZ, Maastricht, the Netherlands.'}, {'ForeName': 'Merel L', 'Initials': 'ML', 'LastName': 'Kimman', 'Affiliation': 'Department of Clinical Epidemiology and Medical Technology, Care and Public Health Research Institute (CAPHRI), Maastricht University Medical Centre, Oxfordlaan 10, 6202, AZ, Maastricht, the Netherlands.'}, {'ForeName': 'Sander M J', 'Initials': 'SMJ', 'LastName': 'Van Kuijk', 'Affiliation': 'Department of Clinical Epidemiology and Medical Technology, Care and Public Health Research Institute (CAPHRI), Maastricht University Medical Centre, Oxfordlaan 10, 6202, AZ, Maastricht, the Netherlands.'}, {'ForeName': 'Robin R', 'Initials': 'RR', 'LastName': 'Van Tol', 'Affiliation': 'Department of Surgery, Diakonessenhuis Medical Centre, Bosboomstraat 1, 3582, KE, Utrecht, the Netherlands.'}, {'ForeName': 'Jean W M', 'Initials': 'JWM', 'LastName': 'Muris', 'Affiliation': 'Department of Family Medicine, Maastricht University, Care and Public Health Research Institute (CAPHRI), Universiteitssingel 40, 6229, ER, Maastricht, the Netherlands.'}, {'ForeName': 'Angus J M', 'Initials': 'AJM', 'LastName': 'Watson', 'Affiliation': 'Department of Surgery, Raigmore Hospital, Old Perth Road, IV2 3UJ Inverness, United Kingdom.'}, {'ForeName': 'Jose M C', 'Initials': 'JMC', 'LastName': 'Maessen', 'Affiliation': 'Department of Quality and Safety, Maastricht University Medical Centre, P. Debyelaan 25, 6229 HX Maastricht, the Netherlands.'}, {'ForeName': 'Jarno', 'Initials': 'J', 'LastName': 'Melenhorst', 'Affiliation': 'Department of Surgery, Maastricht University Medical Centre, P. Debyelaan 25, 6229 HX Maastricht, the Netherlands.'}, {'ForeName': 'Stéphanie O', 'Initials': 'SO', 'LastName': 'Breukink', 'Affiliation': 'Department of Surgery, Maastricht University Medical Centre, P. Debyelaan 25, 6229 HX Maastricht, the Netherlands; Department of Surgery, Maastricht University, School of Nutrition and Translational Research in Metabolism (NUTRIM), School for Oncology and Developmental Biology (GROW), Universiteitssingel 50, 6229, ER, Maastricht, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Contemporary clinical trials,['10.1016/j.cct.2020.106177']
1908,33080393,"Influence of disinfection of caries affected dentin with different concentration of silver diamine fluoride, Curcumin and Er, Cr:YSGG on adhesive bond strength to resin composite.","AIM


The aim of the study was to determine the effect of various disinfectants (CP, MB, 3.8% SDF, 38% SDF and ECL) on caries affected dentine (CAD) and its bond strength to composite restoration MATERIAL AND METHODS: Fifty carious mandibular teeth were collected based on the criteria of ICDAS (International Caries Detection and Assessment system). Specimens up to cement enamel junction were fixed in poly vinyl pipes. All caries molars were grinded using silicon grinding carbon disk and randomly assigned into five groups based on disinfecting regimes (n = 10). Group 1, Caries affected dentin (CAD) treated with MBP [100 mg/L]; Group 2, CAD treated with Curcumin photosensitizer (CP) [500 mg/L]; Group 3, CAD treated with 3.8% SDF Group 4, CAD treated with 38% SDF and group 5 sterile with Er,Cr:YSGG (ECL).Self-etch adhesive bond was smeared over the surface of all specimens followed by application of composite incrementally and light cured. Samples were debonded in a universal testing machine and shear bond strength (SBS) was noted in MegaPascal (MPa). The debonded surfaces were evaluated under stereomicroscope to determine the failure mode. For inter group comparison analysis of variance (ANOVA). Tukey HSD was applied for multiple group comparison. The significance level was kept at p < 0.05 RESULTS: The maximum bond strength was observed in group 2 CAD disinfected with CP (17.57 ± 0.85 MPa). Whereas, minimum bond strength values were presented by group 3 CAD disinfected with 38% SDF (11.14 ± 0.29 MPa). CAD treated with MBP (14.21 ± 0.22 MPa) was comparable to group 5 (p > 0.05). Similarly, group 2 was found to be comparable to group 4 CAD disinfected with 3.8% SDF (16.22±0.53 MPa) (p > 0.05).
CONCLUSION


3.8% SDF and PDT with CP have shown potential to be adopted for dentin disinfection treatment without adversely affecting bond strength of CAD to composite resin.",2020,CAD treated with MBP (14.21 ± 0.22 MPa) was comparable to group 5 (p > 0.05).,[' Fifty carious mandibular teeth were collected based on the criteria of ICDAS (International Caries Detection and Assessment system'],"['various disinfectants (CP, MB, 3.8% SDF, 38% SDF and ECL', 'silver diamine fluoride, Curcumin and Er, Cr:YSGG']","['minimum bond strength values', 'caries affected dentine (CAD', 'maximum bond strength']","[{'cui': 'C0227029', 'cui_str': 'Structure of mandibular teeth'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0012682', 'cui_str': 'Disinfectant'}, {'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C0162713', 'cui_str': 'Photosensitizing agent'}, {'cui': 'C0074538', 'cui_str': 'Silver diamine fluoride'}]","[{'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0806909', 'cui_str': 'Max'}]",,0.0343486,CAD treated with MBP (14.21 ± 0.22 MPa) was comparable to group 5 (p > 0.05).,"[{'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Alrahlah', 'Affiliation': 'Department of Restorative Dental Sciences, College of Dentistry, King Saud University, P. O. Box 60169, Riyadh 11545. Saudi Arabia; Engr. Abdullah Bugshan research chair for Dental and Oral Rehabilitation, King Saud University, Riyadh 11545, Saudi Arabia. Electronic address: alrahlaha@gmail.com.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Naseem', 'Affiliation': 'Department of Community and Preventive Dental Sciences, College of Dentistry Dow International Dental College, Pakistan. Electronic address: Mustafa.naseem@duhs.edu.pk.'}, {'ForeName': 'Syeda A', 'Initials': 'SA', 'LastName': 'Tanveer', 'Affiliation': 'Department of Oral Biology, College of Dentistry, Dow international Dental College, Pakistan. Electronic address: tanvirabeerah@gmail.com.'}, {'ForeName': 'Eisha', 'Initials': 'E', 'LastName': 'Abrar', 'Affiliation': 'Department of Operative Dentistry, Dow International Dental College, Dow University of Health Sciences, Karachi, Pakistan.'}, {'ForeName': 'Amynah C', 'Initials': 'AC', 'LastName': 'Shaikh', 'Affiliation': 'Department of Oral Biology, College of Dentistry, Dow international Dental College, Pakistan. Electronic address: eishaabrar75@gmail.com.'}, {'ForeName': 'Mohammed Q', 'Initials': 'MQ', 'LastName': 'AlRifaiy', 'Affiliation': 'Department of Prosthetic Dental Sciences, College of Dentistry, King Saud University, P. O. Box 60169, Riyadh 11545. Saudi Arabia. Electronic address: resrecprof@gmail.com.'}, {'ForeName': 'Fahim', 'Initials': 'F', 'LastName': 'Vohra', 'Affiliation': 'Engr. Abdullah Bugshan research chair for Dental and Oral Rehabilitation, King Saud University, Riyadh 11545, Saudi Arabia; Department of Prosthetic Dental Sciences, College of Dentistry, King Saud University, P. O. Box 60169, Riyadh 11545. Saudi Arabia. Electronic address: fvohra@ksu.edu.sa.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2020.102065']
1909,33088063,Effectiveness of polyacrylic acid-bioactive glass air abrasion preconditioning with NovaMin remineralization on the microhardness of incipient enamel-like lesion.,"Background


Bioactive glass (BAG) remineralization is a promising method for dental hard tissue regeneration. The aim of this study was to evaluate the microhardness of incipient enamel-like lesions with or without preconditioning by air abrasion using polyacrylic acid (PAA)-BAG before application of NovaMin remineralizing agent.
Materials and Methods


Forty extracted human molars were selected, sectioned mesiodistally obtaining buccal and lingual halves, and embedded in resin molds. Specimens were randomly assigned to four groups ( n  = 10) according to the remineralization protocol: G1 (control, artificial saliva), G2 (preconditioning), G3 (NovaMin), and G4 (preconditioning and NovaMin). Enamel windows 4 mm × 4 mm were done on the buccal and lingual surfaces. Specimens were immersed in a daily renewed demineralizing solution to create white spot lesions. Remineralizing agents were applied according to the manufacturer's instructions, and specimens were stored in a daily renewed artificial saliva. Microhardness was assessed using Vickers hardness number (VHN) at baseline (positive control), after demineralization (negative control), and after 24-h and 1-month remineralization.
Results


The preconditioning/NovaMin group after 1 month showed a statistically significant high VHN, with no statistically significant difference between it and the positive control. This was followed by the NovaMin group after 1 month, while the lowest VHN was found in the demineralized group, with no statistically significant difference between it and the preconditioning group, whether after 24 h or 1 month.
Conclusions


Enamel preconditioning with PAA-BAG air abrasion play a major role in enhancement of remineralization when it is accompanied with NovaMin. Furthermore, an extended period of time had helped to attain more benefits from NovaMin remineralization.
Clinical Significance


Enamel remineralization with NovaMin after conditioning by bioactive glass air abrasion, provides the patients with a fast and durable treatment of incipient enamel lesions, which would reduce the possibility of future progression of demineralization and caries occurrence.",2019,"The preconditioning/NovaMin group after 1 month showed a statistically significant high VHN, with no statistically significant difference between it and the positive control.","['Materials and Methods\n\n\nForty extracted human molars were selected, sectioned mesiodistally obtaining buccal and lingual halves, and embedded in resin molds']","['\n\n\nBioactive glass (BAG) remineralization', 'remineralization protocol: G1 (control, artificial saliva), G2 (preconditioning), G3 (NovaMin), and G4 (preconditioning and NovaMin', 'without preconditioning by air abrasion using polyacrylic acid (PAA)-BAG', 'polyacrylic acid-bioactive glass air abrasion preconditioning with NovaMin remineralization']",['microhardness of incipient enamel-like lesion'],"[{'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C0040408', 'cui_str': 'Tongue structure'}, {'cui': 'C0035191', 'cui_str': 'Resins, Plant'}, {'cui': 'C0369241', 'cui_str': 'Filamentous fungus'}]","[{'cui': 'C0015421', 'cui_str': 'Eyeglasses'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036088', 'cui_str': 'Artificial saliva'}, {'cui': 'C1722474', 'cui_str': 'NovaMin'}, {'cui': 'C1709632', 'cui_str': 'Precondition'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0518443', 'cui_str': 'Abrasion and/or friction burn of skin'}, {'cui': 'C0054720', 'cui_str': 'Carbomer-940'}]","[{'cui': 'C0205256', 'cui_str': 'Incipient'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]",40.0,0.0287373,"The preconditioning/NovaMin group after 1 month showed a statistically significant high VHN, with no statistically significant difference between it and the positive control.","[{'ForeName': 'Abdullah', 'Initials': 'A', 'LastName': 'Alafifi', 'Affiliation': 'Department of Operative Dentistry, Faculty of Oral and Dental Medicine, Misr International University, Cairo, Egypt.'}, {'ForeName': 'Asmaa Aly', 'Initials': 'AA', 'LastName': 'Yassen', 'Affiliation': 'Department of Conservative Dentistry, Faculty of Dentistry, Cairo University, Giza, Egypt.'}, {'ForeName': 'Olfat Elsayed', 'Initials': 'OE', 'LastName': 'Hassanein', 'Affiliation': 'Department of Conservative Dentistry, Faculty of Dentistry, Cairo University, Giza, Egypt.'}]",Journal of conservative dentistry : JCD,['10.4103/JCD.JCD_195_19']
1910,33088069,Effect of different obturating techniques and sealers on the removal of filling materials during endodontic retreatment.,"Background


Adequate removal of previous root filling materials is an important objective during endodontic retreatment.
Aim


This study was aimed to evaluate the influence of obturation quality and sealer type on the removal of root filling materials during endodontic retreatment using micro-computed tomography (μ-CT).
Materials and Methods


Ninety extracted mandibular premolars were randomly assigned to two groups ( n  = 45) based on the type of sealer (AH Plus and BioRoot RCS) and three sub-groups based on the obturating technique used, i.e., cold lateral condensation, warm vertical compaction, and thermoplasticized injectable techniques. Specimens were scanned using μ-CT before and after retreatment to assess the amount of filling material, and time taken for removal was recorded.
Statistical Analysis


Data were analyzed using two-way analysis of variance and Tukey's multiple  post hoc  test at 5% significance level.
Results


Filling debris percentage and retreatment time were not significantly affected by the type of sealer ( P  ≥ 0.05). The percentage of remaining filling material was higher in teeth obturated with thermoplasticized technique ( P  < 0.05). Significantly more filling material debris was observed in apical third ( P  < 0.05).
Conclusions


The type of obturating technique used for initial root canal treatment has influenced the amount of remaining filling material and retreatment time. Retreatability of the BioRoot RCS sealer was similar to the AH Plus sealer.",2019,Filling debris percentage and retreatment time were not significantly affected by the type of sealer ( P  ≥ 0.05).,['Materials and Methods\n\n\nNinety extracted mandibular premolars'],"['BioRoot RCS sealer', 'sealer (AH', 'endodontic retreatment using micro-computed tomography (μ-CT', 'Plus and BioRoot RCS']","['percentage of remaining filling material', 'Filling debris percentage and retreatment time', 'removal of filling materials', 'filling material debris']","[{'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}]","[{'cui': 'C0449942', 'cui_str': 'Sealer'}, {'cui': 'C0332274', 'cui_str': 'Endodontic'}, {'cui': 'C0376495', 'cui_str': 'Retreatments'}, {'cui': 'C0085672', 'cui_str': 'Microbiology procedure'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0440266', 'cui_str': 'Debris'}, {'cui': 'C0376495', 'cui_str': 'Retreatments'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0440137', 'cui_str': 'Filling material'}]",90.0,0.0278311,Filling debris percentage and retreatment time were not significantly affected by the type of sealer ( P  ≥ 0.05).,"[{'ForeName': 'Srividya', 'Initials': 'S', 'LastName': 'Athkuri', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, GITAM Dental College and Hospital, Visakhapatnam, Andhra Pradesh, India.'}, {'ForeName': 'Jyothi', 'Initials': 'J', 'LastName': 'Mandava', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, GITAM Dental College and Hospital, Visakhapatnam, Andhra Pradesh, India.'}, {'ForeName': 'Uma', 'Initials': 'U', 'LastName': 'Chalasani', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, GITAM Dental College and Hospital, Visakhapatnam, Andhra Pradesh, India.'}, {'ForeName': 'Ravi Chandra', 'Initials': 'RC', 'LastName': 'Ravi', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, GITAM Dental College and Hospital, Visakhapatnam, Andhra Pradesh, India.'}, {'ForeName': 'Vamsi Krishna', 'Initials': 'VK', 'LastName': 'Munagapati', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, GITAM Dental College and Hospital, Visakhapatnam, Andhra Pradesh, India.'}, {'ForeName': 'Anusha Reddy', 'Initials': 'AR', 'LastName': 'Chennareddy', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, GITAM Dental College and Hospital, Visakhapatnam, Andhra Pradesh, India.'}]",Journal of conservative dentistry : JCD,['10.4103/JCD.JCD_241_19']
1911,33088070,Evaluation of temperature rise and efficacy of cavity disinfection with diode laser: An  in vivo  study.,"Background


Management of caries using minimally invasive dentistry is prevalent in dentistry today. A newer technology is to disinfect/sterilize caries in depth of the dental tissue with diode laser. However, to have a bactericidal effect, increased energy density of light amplification by stimulated emission of radiation (LASER) may be required which in turn may lead to higher thermal load causing harmful effects on vital pulpal tissue.
Aims


The aim was to evaluate temperature rise and efficacy of cavity disinfection with diode laser.
Materials and Methods


Twenty permanent molar teeth with dentinal caries were randomly assigned into two groups on the basis of LASER irradiation: Group 1 - at 1 W, Group 2 - at 2 W. The elevation of subsurface temperature during irradiation was measured using thermocouples positioned in the center of a prepared cavity. Dentinal samples were collected before and after disinfection of the cavity. These samples were subjected to microbiological evaluation for  Streptococcus mutans  on Mutans-Sanguis agar and  Lactobacilli  on Rogosa agar.
Statistical Analysis


Log transformed "" t ""-test and paired "" t ""-test were used for the statistical analysis.
Results


Although the reduction in microbial count revealed insignificant difference at two different wattages, the rise in temperature with 1 W was less than that with 2 W.
Conclusion


Efficacy of 1 W and 2 W is similar, but 1 W causes less thermal changes, thus, 1 W is recommended over 2 W.",2019,"Although the reduction in microbial count revealed insignificant difference at two different wattages, the rise in temperature with 1 W was less than that with 2 W.
Conclusion


Efficacy of 1 W and 2 W is similar, but 1 W causes less thermal changes, thus, 1 W is recommended over 2 W.",['Twenty permanent molar teeth with dentinal caries'],"['cavity disinfection with diode laser', 'LASER irradiation']",['elevation of subsurface temperature'],"[{'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}]","[{'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0012683', 'cui_str': 'Disinfection'}, {'cui': 'C0392254', 'cui_str': 'Semiconductor laser device'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0233929', 'cui_str': 'Emission'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}]","[{'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}]",20.0,0.0461597,"Although the reduction in microbial count revealed insignificant difference at two different wattages, the rise in temperature with 1 W was less than that with 2 W.
Conclusion


Efficacy of 1 W and 2 W is similar, but 1 W causes less thermal changes, thus, 1 W is recommended over 2 W.","[{'ForeName': 'Sakshi', 'Initials': 'S', 'LastName': 'Jain', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, I.T.S Centre for Dental Studies and Research, Ghaziabad, Uttar Pradesh, India.'}, {'ForeName': 'Shivani', 'Initials': 'S', 'LastName': 'Mathur', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, I.T.S Centre for Dental Studies and Research, Ghaziabad, Uttar Pradesh, India.'}, {'ForeName': 'Pulkit', 'Initials': 'P', 'LastName': 'Jhingan', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, I.T.S Centre for Dental Studies and Research, Ghaziabad, Uttar Pradesh, India.'}, {'ForeName': 'Vinod', 'Initials': 'V', 'LastName': 'Sachdev', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, I.T.S Centre for Dental Studies and Research, Ghaziabad, Uttar Pradesh, India.'}]",Journal of conservative dentistry : JCD,['10.4103/JCD.JCD_78_19']
1912,33088071,Evaluation of remaining dentin thickness following use of three different rotary nickel-titanium retreatment files: A cone-beam computed tomography study.,"Aim


The aim of the study is to measure the amount of remaining dentin thickness (RDT) following retreatment using three different rotary nickel-titanium (NiTi) systems.
Methodology


Mesiobuccal roots of 45 extracted maxillary first molars were prepared up to F 2  ProTaper File and obturated. After cone-beam computed tomography (CBCT) imaging, to evaluate the obturation, the samples were randomly assigned to three retreatment groups ( n  = 15). Group I was retreated with ProTaper Universal retreatment kit, Group II and III with M TWO  and D-Race retreatment files, respectively. Postoperatively, all samples were subjected to CBCT imaging and evaluated with AutoCAD software (AutoDesk, Inc.) Mill Valley, California, U.S. to calculate the RDT. Data were statistically analyzed using one-way ANOVA and Tukey's  post hoc  tests, and the level of significance was set at  P  = 0.05.
Results


The amount of RDT was significantly more in D-Race and M TWO  groups when compared to ProTaper group.
Conclusion


D-Race and M TWO  instruments were associated with significantly more RDT than ProTaper.",2019,"The amount of RDT was significantly more in D-Race and M TWO  groups when compared to ProTaper group.
",['45 extracted maxillary first molars'],"['rotary nickel-titanium (NiTi) systems', 'cone-beam computed tomography (CBCT) imaging']","['remaining dentin thickness (RDT', 'amount of RDT']","[{'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0227056', 'cui_str': 'Structure of mandibular left first molar tooth'}]","[{'cui': 'C0068790', 'cui_str': 'nitinol'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C1956110', 'cui_str': 'Cone beam CT'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}]","[{'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}]",45.0,0.0267567,"The amount of RDT was significantly more in D-Race and M TWO  groups when compared to ProTaper group.
","[{'ForeName': 'Nishita Rajeev', 'Initials': 'NR', 'LastName': 'Kulkarni', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Bharati Vidyapeeth Deemed University, Dental College and Hospital, Sangli, Maharashtra, India.'}, {'ForeName': 'Sharad Basavraj', 'Initials': 'SB', 'LastName': 'Kamat', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Bharati Vidyapeeth Deemed University, Dental College and Hospital, Sangli, Maharashtra, India.'}, {'ForeName': 'Santosh Irappa', 'Initials': 'SI', 'LastName': 'Hugar', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Bharati Vidyapeeth Deemed University, Dental College and Hospital, Sangli, Maharashtra, India.'}, {'ForeName': 'Girish Shankar', 'Initials': 'GS', 'LastName': 'Nanjannawar', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Bharati Vidyapeeth Deemed University, Dental College and Hospital, Sangli, Maharashtra, India.'}, {'ForeName': 'Pranav Devendra', 'Initials': 'PD', 'LastName': 'Patil', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Bharati Vidyapeeth Deemed University, Dental College and Hospital, Sangli, Maharashtra, India.'}]",Journal of conservative dentistry : JCD,['10.4103/JCD.JCD_269_19']
1913,33088072,Comparative evaluation of push-out bond strength of gutta-percha using different sealers with lateral condensation and thermoplasticized obturation technique: An  in vitro  study.,"Aim


The study aimed to evaluate and compare the push-out bond strength of gutta-percha using AH plus, Endosequence BC, and Roeko seal sealer with lateral condensation and thermoplasticized obturation technique.
Materials and Methods


Sixty single-rooted premolars were instrumented and samples were randomly assigned into three groups based on the sealer used (Group A-AH Plus, Group B-Endosequence BC, Group C-Roeko Seal) which were further divided into two subgroups-A1, B1, and C1 were obturated by the lateral condensation technique and A2, B2, and C2 using the thermoplasticized technique. Each sample was sectioned horizontally using a diamond disc, representing apical, middle, and coronal thirds, respectively. Root segments were then mounted on an acrylic block, and push-out bond strength of each sample was tested using the universal testing machine.
Statistical Analysis


One-way ANOVA, Tukey's test, and unpaired  t -test.
Results


For mandibular premolar teeth with a single canal using lateral condensation technique, the highest push-out bond strength was found in the A1 group (7.30 ± 0.61 MPa) at the apical level. While using the thermoplasticized technique, the highest push-out bond strength was found in the B2 group (3.71 ± 0.81 MPa) at the apical level. Overall results showed that the lateral condensation technique showed significantly higher push-out bond strength than thermoplasticized technique ( P  < 0.028).
Conclusions


The push-out bond strength of AH Plus sealer was higher than the Endosequence BC sealer and Roeko seal sealer. Lateral condensation technique has shown higher push-out bond strength than the thermoplasticized technique.",2019,"Overall results showed that the lateral condensation technique showed significantly higher push-out bond strength than thermoplasticized technique ( P  < 0.028).
",['Materials and Methods\n\n\nSixty single-rooted premolars were instrumented and samples'],"['push-out bond strength of gutta-percha using different sealers with lateral condensation and thermoplasticized obturation technique', 'sealer used (Group A-AH Plus, Group B-Endosequence BC, Group C-Roeko Seal', 'gutta-percha using AH plus, Endosequence BC, and Roeko seal sealer with lateral condensation and thermoplasticized obturation technique']","['highest push-out bond strength', 'higher push-out bond strength']","[{'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0580841', 'cui_str': 'Does push'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}, {'cui': 'C0018407', 'cui_str': 'Gutta percha'}, {'cui': 'C0449942', 'cui_str': 'Sealer'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0233656', 'cui_str': 'Mental condensation'}, {'cui': 'C0449861', 'cui_str': 'Obturation technique'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0673096', 'cui_str': 'AH Plus'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C1143479', 'cui_str': 'roeko seal'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0580841', 'cui_str': 'Does push'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}]",60.0,0.0116787,"Overall results showed that the lateral condensation technique showed significantly higher push-out bond strength than thermoplasticized technique ( P  < 0.028).
","[{'ForeName': 'Naushad', 'Initials': 'N', 'LastName': 'Ali', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, College of Dental Science and Hospital, Indore, Madhya Pradesh, India.'}, {'ForeName': 'Suparna Ganguly', 'Initials': 'SG', 'LastName': 'Saha', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, College of Dental Science and Hospital, Indore, Madhya Pradesh, India.'}, {'ForeName': 'Prashansa', 'Initials': 'P', 'LastName': 'Vijayvargiya', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, College of Dental Science and Hospital, Indore, Madhya Pradesh, India.'}, {'ForeName': 'Anuj', 'Initials': 'A', 'LastName': 'Bhardwaj', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, College of Dental Science and Hospital, Indore, Madhya Pradesh, India.'}, {'ForeName': 'Saurabh', 'Initials': 'S', 'LastName': 'Shrivastava', 'Affiliation': 'Department of Prosthodontics, Mansarovar Dental College, Bhopal, Madhya Pradesh, India.'}, {'ForeName': 'Vini', 'Initials': 'V', 'LastName': 'Sharma', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, College of Dental Science and Hospital, Indore, Madhya Pradesh, India.'}, {'ForeName': 'Harmeet Singh', 'Initials': 'HS', 'LastName': 'Sachdeva', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, College of Dental Science and Hospital, Indore, Madhya Pradesh, India.'}]",Journal of conservative dentistry : JCD,['10.4103/JCD.JCD_553_18']
1914,33088326,Efficacy of synbiotic supplementation in improving rheumatoid arthritis.,"Background and purpose


Today, improving rheumatoid arthritis (RA) as a chronic inflammatory disease is attributed to the proper status of the gut microbiota. Although some supplements containing beneficial live microorganisms (probiotics) can reduce inflammation by altering the bacterial composition of the gut, there is limited information on the effect of synbiotic (probiotics mixed with prebiotics) supplements on RA. Therefore, this study aimed to evaluate the anti-inflammatory effects of a synbiotic supplement as an adjuvant therapy in rheumatic patients. Moreover, for the first time, it was attempted to investigate whether addition of a synbiotic (1000 mg/day) to the combination of methotrexate and prednisolone increases the effectiveness of these antirheumatic drugs.
Experimental approach


Eligible patients (186 subjects) were randomly divided into two groups. Both groups received their standard routine antirheumatic drugs, methotrexate and prednisolone. Moreover, the first group received a daily oral synbiotic supplement (1000 mg) for 3 months while the second group received a placebo. Various parameters indicating RA status were evaluated at baseline (time 0) and 3 months after the treatment.
Findings / Results


The results showed the changes in the level of RA indicators, including tender joint count with a range of 0 to 28 joints, swollen joint count with a range of 0 to 28 joints, visual analog scale, erythrocyte sedimentation rate, CRP, and disease activity score based on 28 joints, after 3 months.
Conclusion and implications


Overall, no significant differences in the measured parameters were observed between synbiotic and placebo groups probably due to the short duration of the treatment period, and it is suggested to extend the treatment period to six months.",2020,"Overall, no significant differences in the measured parameters were observed between synbiotic and placebo groups probably due to the short duration of the treatment period, and it is suggested to extend the treatment period to six months.","['rheumatic patients', 'Experimental approach\n\n\nEligible patients (186 subjects']","['synbiotic supplementation', 'synbiotic', 'synbiotic supplement', 'placebo', 'methotrexate and prednisolone', 'daily oral synbiotic supplement']","['rheumatoid arthritis', 'level of RA indicators, including tender joint count with a range of 0 to 28 joints, swollen joint count with a range of 0 to 28 joints, visual analog scale, erythrocyte sedimentation rate, CRP, and disease activity score', 'RA status']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C2936470', 'cui_str': 'Synbiotics'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0451530', 'cui_str': 'Tender joint count'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0451521', 'cui_str': 'Swollen joint count'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",,0.0315122,"Overall, no significant differences in the measured parameters were observed between synbiotic and placebo groups probably due to the short duration of the treatment period, and it is suggested to extend the treatment period to six months.","[{'ForeName': 'Farah', 'Initials': 'F', 'LastName': 'Esmaeili', 'Affiliation': 'Rheumatology Clinic of the Internal Medicine Department, School of Medicine, Isfahan university of Medical Science, Isfahan, I.R. Iran.'}, {'ForeName': 'Mansour', 'Initials': 'M', 'LastName': 'Salesi', 'Affiliation': 'Rheumatology Clinic of the Internal Medicine Department, School of Medicine, Isfahan university of Medical Science, Isfahan, I.R. Iran.'}, {'ForeName': 'Gholamreza', 'Initials': 'G', 'LastName': 'Askari', 'Affiliation': 'Department of Community Nutrition, School of Nutrition and Food Sciences, Isfahan university of Medical Science, Isfahan, I.R. Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Esmaeilisharif', 'Affiliation': 'Rheumatology Clinic of the Internal Medicine Department, School of Medicine, Isfahan university of Medical Science, Isfahan, I.R. Iran.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Maracy', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Health, Isfahan university of Medical Science, Isfahan, I.R. Iran.'}, {'ForeName': 'Hadi', 'Initials': 'H', 'LastName': 'Karimzadeh', 'Affiliation': 'Rheumatology Clinic of the Internal Medicine Department, School of Medicine, Isfahan university of Medical Science, Isfahan, I.R. Iran.'}, {'ForeName': 'Behrokh', 'Initials': 'B', 'LastName': 'Shojaie', 'Affiliation': 'Department of Biology, Faculty of Science, University of Isfahan, Isfahan, I.R. Iran.'}]",Research in pharmaceutical sciences,['10.4103/1735-5362.288432']
1915,33088361,Effects of Nintedanib on Quantitative Lung Fibrosis Score in Idiopathic Pulmonary Fibrosis.,"Background


Nintedanib slows disease progression in patients with Idiopathic Pulmonary Fibrosis (IPF) by reducing decline in Forced Vital Capacity (FVC). The effects of nintedanib on abnormalities on high-resolution computed tomography scans have not been previously studied.
Objective


We conducted a Phase IIIb trial to assess the effects of nintedanib on changes in Quantitative Lung Fibrosis (QLF) score and other measures of disease progression in patients with IPF.
Methods


113 patients were randomized 1:1 to receive nintedanib 150 mg bid or placebo double-blind for ≥6 months, followed by open-label nintedanib. The primary endpoint was the relative change from baseline in QLF score (%) at month 6. Analyses were descriptive and exploratory.
Results


Adjusted mean relative changes from baseline in QLF score at month 6 were 11.4% in the nintedanib group (n=42) and 14.6% in the placebo group (n=45) (difference 3.2% [95% CI: -9.2, 15.6]). Adjusted mean absolute changes from baseline in QLF score at month 6 were 0.98% and 1.33% in these groups, respectively (difference 0.35% [95% CI: -1.27, 1.96]). Adjusted mean absolute changes from baseline in FVC at month 6 were -14.2 mL and -83.2 mL in the nintedanib (n=54) and placebo (n=54) groups, respectively (difference 69.0 mL [95% CI: -8.7, 146.8]).
Conclusion


Exploratory data suggest that in patients with IPF, 6 months' treatment with nintedanib was associated with a numerically smaller degree of fibrotic change in the lungs and reduced FVC decline versus placebo. These data support previous findings that nintedanib slows the progression of IPF.",2020,"Adjusted mean absolute changes from baseline in FVC at month 6 were -14.2 mL and -83.2 mL in the nintedanib (n=54) and placebo (n=54) groups, respectively (difference 69.0 mL","['Idiopathic Pulmonary Fibrosis', '113 patients', 'patients with Idiopathic Pulmonary Fibrosis (IPF', 'patients with IPF']","['nintedanib 150 mg bid or placebo double-blind for ≥6 months, followed by open-label nintedanib', 'Nintedanib', 'placebo', 'nintedanib']","['relative change from baseline in QLF score', 'Quantitative Lung Fibrosis (QLF) score', 'QLF score', 'Quantitative Lung Fibrosis Score']","[{'cui': 'C1800706', 'cui_str': 'Idiopathic pulmonary fibrosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C3859348', 'cui_str': 'nintedanib 150 MG'}, {'cui': 'C0048106', 'cui_str': ""4-benzamido-4'-isothiocyanostilbene-2,2'-disulfonate""}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C2930789', 'cui_str': 'nintedanib'}]","[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0034069', 'cui_str': 'Fibrosis of lung'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",113.0,0.276847,"Adjusted mean absolute changes from baseline in FVC at month 6 were -14.2 mL and -83.2 mL in the nintedanib (n=54) and placebo (n=54) groups, respectively (difference 69.0 mL","[{'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Lancaster', 'Affiliation': 'Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Goldin', 'Affiliation': 'Department of Radiology, University of California, Los Angeles, California, USA.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Trampisch', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Grace Hyun', 'Initials': 'GH', 'LastName': 'Kim', 'Affiliation': 'Department of Radiology, University of California, Los Angeles, California, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Ilowite', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Medicine, Hofstra North Shore-LIJ School of Medicine, New Hyde Park, New York.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Homik', 'Affiliation': 'Department of Respiratory Medicine and Bronchoscopy, Winnipeg Clinic, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Hotchkin', 'Affiliation': 'The Oregon Clinic, Division of Pulmonary, Critical Care & Sleep Medicine, Portland, Oregon, USA.'}, {'ForeName': 'Mitchell', 'Initials': 'M', 'LastName': 'Kaye', 'Affiliation': 'Department of Pulmonary Medicine, Minnesota Lung Center, Ltd., Minneapolis, Minnesota, USA.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Ryerson', 'Affiliation': 'Department of Medicine & Centre for Heart Lung Innovation, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Nesrin', 'Initials': 'N', 'LastName': 'Mogulkoc', 'Affiliation': 'Department of Pulmonology, Ege University Hospital, Bornova, Izmir, Turkey.'}, {'ForeName': 'Craig S', 'Initials': 'CS', 'LastName': 'Conoscenti', 'Affiliation': 'Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut, USA.'}]",The open respiratory medicine journal,['10.2174/1874306402014010022']
1916,33088443,Antenatal Care and Weight Gain in Adolescent Compared to Adult Pregnancy.,"Background


The aim of this study is to compare the antenatal care, body weight, and weight gain in pregnancy between the adolescent and adult pregnancies and, thus, examine the impact of adolescence on the studied parameters.
Methods


This prospective study includes 300 pregnant women who were the patients of University Clinical Center Tuzla, Clinic for Gynecology and Obstetrics from January 2011 to December 2014. The women were divided into two groups: an experimental group consisted of 150 adolescent pregnant women aged 13-19 years and a control group consisted of 150 adult pregnant women aged 20-35 years. The following parameters were analyzed: age of pregnant women, number of antenatal controls in pregnancy, prepregnancy body weight, weight gain in pregnancy, parity, and obstetric history data.
Results


A significantly higher number of adolescent pregnant women belongs to a subgroup from one to two examinations during pregnancy ( P  < 0.000013) and to subgroups from three to five examinations ( P  < 0.000001). A significantly smaller number of adolescent pregnant women performed their first antenatal control in the first 2 lunar months ( P  < 0.01). A subgroup with optimal body weight (from 51 to 69 kg) are the most prevalent among adolescent pregnant women ( P  < 0.000001). A significantly larger number of adolescent pregnant women had an optimal weight gain of 7.8 to 12.99 kg ( P  < 0.001).
Conclusions


The adolescent pregnant women have suboptimal antenatal care, which could lead to adverse maternal and birth outcomes, but have optimal body weight and weight gain during pregnancy.",2020,A significantly higher number of adolescent pregnant women belongs to a subgroup from one to two examinations during pregnancy ( P  < 0.000013) and to subgroups from three to five examinations ( P  < 0.000001).,"['150 adolescent pregnant women aged 13-19 years and a control group consisted of 150 adult pregnant women aged 20-35 years', 'pregnant women, number of antenatal controls in pregnancy, prepregnancy body weight, weight gain in pregnancy, parity, and obstetric history data', '300 pregnant women who were the patients of University Clinical Center Tuzla, Clinic for Gynecology and Obstetrics from January 2011 to December 2014', 'adolescent pregnant women', 'Adolescent']",[],"['optimal weight gain', 'antenatal care, body weight, and weight gain']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0030563', 'cui_str': 'Parity'}, {'cui': 'C0425963', 'cui_str': 'Obstetric history'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}]",[],"[{'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]",150.0,0.0336619,A significantly higher number of adolescent pregnant women belongs to a subgroup from one to two examinations during pregnancy ( P  < 0.000013) and to subgroups from three to five examinations ( P  < 0.000001).,"[{'ForeName': 'Sergije', 'Initials': 'S', 'LastName': 'Marković', 'Affiliation': 'Department of Histology and Embryology, School of Medicine, University of Tuzla, Tuzla, Bosnia and Herzegovina.'}, {'ForeName': 'Anis', 'Initials': 'A', 'LastName': 'Cerovac', 'Affiliation': 'Department of Gynaecology and Obstetrics, General Hospital Tešanj, Tešanj, Bosnia and Herzegovina.'}, {'ForeName': 'Elmedina', 'Initials': 'E', 'LastName': 'Cerovac', 'Affiliation': 'Department of Anesthesiology, Reanimatology and Intensive Care, General Hospital Tešanj, Tešanj, Bosnia and Herzegovina.'}, {'ForeName': 'Dragana', 'Initials': 'D', 'LastName': 'Marković', 'Affiliation': 'Department of Anesthesiology, Reanimatology and Perioperative medicine, University Clinical Center Ljubljana, Ljubljana, Republic of Slovenia.'}, {'ForeName': 'Gordana', 'Initials': 'G', 'LastName': 'Bogdanović', 'Affiliation': 'Clinic for Gynecology and Obstetrics, University Clinical Center Tuzla, Tuzla, Bosnia and Herzegovina.'}, {'ForeName': 'Suad', 'Initials': 'S', 'LastName': 'Kunosić', 'Affiliation': 'Department of Physics, School of Natural Sciences and Mathematics, University of Tuzla, Tuzla, Bosnia and Herzegovina.'}]",International journal of preventive medicine,['10.4103/ijpvm.IJPVM_374_19']
1917,33088456,Effects of Aquatic Exercise on Dimensions of Quality of Life and Blood Indicators in Patients with Beta-Thalassemia Major.,"Background


Thalassemia is considered as a group of genetic blood disorders, characterized by anemia. The present research aimed at evaluating the effects of aquatic exercise on quality of life and blood indices in patients with beta-thalassemia major.
Methods


A clinical trial study involving 40 patients with thalassemia major, divided into two groups: experimental and control. The tools used to collect the data included demographic information questionnaire, blood indicators questionnaire, and SF-36 quality of life questionnaire. The experimental group performed exercise in water three times per week for 8 weeks in the pool after obtaining the consent. In this research, the quality of life questionnaire was filled out 24 h before the intervention, 24 h after the last session of the exercise program, and 2 months after the end of the exercise program.
Results


The current research revealed that exercise in water affected the quality of life, hemoglobin, hematocrit, iron and ferritin of serum such that the mean score of quality of life and blood indicators in the study showed a significant difference in the experimental group.
Conclusions


The use of a regular exercise program combined with drug therapy and blood transfusion can be useful in the treatment of beta-thalassemia patients.",2020,"The current research revealed that exercise in water affected the quality of life, hemoglobin, hematocrit, iron and ferritin of serum such that the mean score of quality of life and blood indicators in the study showed a significant difference in the experimental group.
","['Patients with Beta-Thalassemia Major', 'patients with beta-thalassemia major', 'beta-thalassemia patients', '40 patients with thalassemia major, divided into two groups: experimental and control']","['regular exercise program combined with drug therapy and blood transfusion', 'Aquatic Exercise', 'aquatic exercise']","['Dimensions of Quality of Life and Blood Indicators', 'quality of life questionnaire', 'quality of life, hemoglobin, hematocrit, iron and ferritin of serum such that the mean score of quality of life and blood indicators', 'demographic information questionnaire, blood indicators questionnaire, and SF-36 quality of life questionnaire', 'quality of life and blood indices']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002875', 'cui_str': 'Homozygous beta thalassemia'}, {'cui': 'C0005283', 'cui_str': 'beta Thalassemia'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0582191', 'cui_str': 'Regular exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0015879', 'cui_str': 'Ferritin'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",40.0,0.024859,"The current research revealed that exercise in water affected the quality of life, hemoglobin, hematocrit, iron and ferritin of serum such that the mean score of quality of life and blood indicators in the study showed a significant difference in the experimental group.
","[{'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Hasanpour Dehkordi', 'Affiliation': 'Social Determinants of Health Research Center, School of Allied Medical Sciences, Shahrekord University of Medical Sciences, Shahrekord, Iran.'}, {'ForeName': 'Toba', 'Initials': 'T', 'LastName': 'Hasani', 'Affiliation': 'Student Research Committee, Shahrekord University of Medical Sciences, Shahrekord, Iran.'}, {'ForeName': 'Kiavash', 'Initials': 'K', 'LastName': 'Fekri', 'Affiliation': 'Cancer Research Development Center, Shahrekord University of Medical Sciences, Shahrekord, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Deris', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Health, Shahrekord University of Medical Sciences (SKUMS), Shahrekord, Iran.'}, {'ForeName': 'Shahram', 'Initials': 'S', 'LastName': 'Etemadifar', 'Affiliation': 'Department of Adult and Elderly Nursing, Faculty of Nursing and Midwifery, Shahrekord University of Medical Sciences, Shahrekord, Iran.'}]",International journal of preventive medicine,['10.4103/ijpvm.IJPVM_290_19']
1918,33088648,"Effect of tasteless calorie-free gum chewing before meal on postprandial plasma glucose, insulin, glucagon, and gastrointestinal hormones in Japanese men without diagnosed glucose metabolism disorder: a pilot randomized crossover trial.","This pilot study aimed to examine the effect of pre-meal tasteless calorie-free gum chewing on post-meal blood levels of glucose, insulin, glucagon, and gastrointestinal hormones. This was an open-label, randomized, 2-sequence, 3-period, 2-treatment crossover trial with a 1:1 allocation. Sixteen Japanese adult male volunteers aged between 30 and 49 years without diagnosed glucose metabolism disorder were enrolled. Ingestion of 200-g cooked rice after 15-min tasteless calorie-free gum chewing (GUM+ treatment) was compared to that without preceding gum chewing (GUM- treatment). Cooked rice was divided into twelve equally sized portions and consumed by chewing each portion 30 times before swallowing. Treatment sessions were separated by an at least 1-week interval and attended after an overnight fast. Circulating levels of glucose, insulin, glucagon, active glucagon-like peptide (GLP)-1 and ghrelin were measured at baseline (before treatment) and 0, 15, 30, 60, and 120 min after completion of the meal ingestion, and the postprandial change from baseline was assessed. As a result, the change in glucose levels at 0 min was significantly lower in the GUM+ treatment than in the GUM- treatment ( P  = 0.004). Furthermore, the GUM+ treatment demonstrated higher incremental insulin levels at 15 min ( P  = 0.041) and higher incremental active GLP-1 levels at 30 and 60 min ( P  = 0.018 and 0.021, respectively); whereas, postprandial glucagon and ghrelin levels were not significantly different. In conclusion, the current pilot study demonstrated that tasteless calorie-free gum chewing before rice eating had a significant but limited impact on the increase of postprandial active GLP-1 levels in male individuals without diagnosed glucose metabolism disorder.",2020,"Furthermore, the GUM+ treatment demonstrated higher incremental insulin levels at 15 min ( P  = 0.041) and higher incremental active GLP-1 levels at 30 and 60 min ( P  = 0.018 and 0.021, respectively); whereas, postprandial glucagon and ghrelin levels were not significantly different.","['Japanese men without diagnosed glucose metabolism disorder', 'Sixteen Japanese adult male volunteers aged between 30 and 49\xa0years without diagnosed glucose metabolism disorder\xa0were enrolled', 'male individuals without diagnosed glucose metabolism disorder']","['tasteless calorie-free gum chewing before meal', 'GUM', 'pre-meal tasteless calorie-free gum chewing']","['Circulating levels of glucose, insulin, glucagon, active glucagon-like peptide (GLP)-1 and ghrelin', 'postprandial plasma glucose, insulin, glucagon, and gastrointestinal hormones', 'postprandial glucagon and ghrelin levels', 'postprandial active GLP-1 levels', 'change in glucose levels', 'post-meal blood levels of glucose, insulin, glucagon, and gastrointestinal hormones', 'incremental active GLP-1 levels', 'incremental insulin levels']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1257958', 'cui_str': 'Disorder of glucose metabolism'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0024888', 'cui_str': 'Mastication'}, {'cui': 'C1550738', 'cui_str': 'Before food'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C1998602', 'cui_str': 'Meals'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0017687', 'cui_str': 'Glucagon'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0017182', 'cui_str': 'Gastrointestinal hormone'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement'}]",16.0,0.0311784,"Furthermore, the GUM+ treatment demonstrated higher incremental insulin levels at 15 min ( P  = 0.041) and higher incremental active GLP-1 levels at 30 and 60 min ( P  = 0.018 and 0.021, respectively); whereas, postprandial glucagon and ghrelin levels were not significantly different.","[{'ForeName': 'Mitsuyoshi', 'Initials': 'M', 'LastName': 'Takahara', 'Affiliation': 'Department of Diabetes Care Medicine, Osaka University Graduate School of Medicine, 2-2 Yamada-oka, Suita, Osaka 565-0871 Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Fukuda', 'Affiliation': 'Fukuda Clinic, 1-6-1 Miyahara, Yodogawa-ku, Osaka, Osaka 532-0003 Japan.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Matsuzawa', 'Affiliation': 'Sumitomo Hospital, 5-3-20 Nakanoshima, Osaka, Osaka 530-0005 Japan.'}, {'ForeName': 'Iichiro', 'Initials': 'I', 'LastName': 'Shimomura', 'Affiliation': 'Department of Metabolic Medicine, Osaka University Graduate School of Medicine, 2-2 Yamada-oka, Suita, Osaka 565-0871 Japan.'}]",Diabetology international,['10.1007/s13340-020-00435-9']
1919,33088738,"In Vivo  Effects of Nonselective, Partially Selective, and Selective Non Steroidal Anti-Inflammatory Drugs on Lipid Peroxidation and Antioxidant Enzymes in Patients with Rheumatoid Arthritis: A Clinical Study.","Background


The relationship between oxidative stress, decreased antioxidant status, and rheumatoid arthritis (RA) has been widely investigated. To date, few clinical studies have assessed the role of conventional nonsteroidal anti-inflammatory drugs (NSAIDs) in the modulation of oxidative stress in patients with RA.
Aim


The aim of this study was to compare the effects of nonselective, partially selective, and selective cyclooxygenase (COX) inhibitors on markers of oxidative stress in patients with RA.
Materials and Methods


Thirty RA patients were enrolled in this open label, prospective study for 12 weeks and randomly assigned to either group receiving diclofenac 100 mg, meloxicam 15 mg, or celecoxib 200 mg daily ( n  = 10 in each group). Patients were evaluated for superoxide dismutase (SOD) and serum malondialdehyde (MDA) as oxidative markers at the baseline and at the end of 12 weeks. Various parameters for efficacy were also assessed.
Results


The baseline values of the SOD enzyme were significantly lower and MDA values were significantly elevated in patients randomized to the three treatment groups as compared to the control group ( P  < 0.05). MDA level was significantly decreased in patients across all the treatment groups ( P  < 0.05) after 12 weeks. There was an improvement in mean SOD enzyme levels at the end of 12 weeks; the difference for SOD was significant as compared to the baseline in the meloxicam group only ( P  < 0.05) but not in diclofenac- and celecoxib-treated patients. Significant improvement was observed in all the treatment groups as regards patient assessment of pain visual analog scale, tender and swollen joint count, and patient global assessment.
Conclusions


Diclofenac, meloxicam, and celecoxib carry antioxidant effects to a variable extent. NSAID possesses additional mechanism independent of COX inhibition which modulates oxidative stress.",2020,The baseline values of the SOD enzyme were significantly lower and MDA values were significantly elevated in patients randomized to the three treatment groups as compared to the control group ( P  < 0.05).,"['Materials and Methods\n\n\nThirty RA patients', 'patients with RA', 'Patients with Rheumatoid Arthritis']","['Diclofenac, meloxicam, and celecoxib', 'celecoxib', 'diclofenac 100 mg, meloxicam 15 mg, or celecoxib', 'meloxicam', 'Nonselective, Partially Selective, and Selective Non Steroidal Anti-Inflammatory Drugs', 'nonselective, partially selective, and selective cyclooxygenase (COX) inhibitors']","['mean SOD enzyme levels', 'superoxide dismutase (SOD) and serum malondialdehyde (MDA) as oxidative markers', 'baseline values of the SOD enzyme', 'MDA level', 'oxidative stress', 'MDA values', 'SOD', 'pain visual analog scale, tender and swollen joint count, and patient global assessment', 'Lipid Peroxidation and Antioxidant Enzymes']","[{'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0012091', 'cui_str': 'Diclofenac'}, {'cui': 'C0083381', 'cui_str': 'meloxicam'}, {'cui': 'C0538927', 'cui_str': 'celecoxib'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C1128682', 'cui_str': 'meloxicam 15 MG'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C0085387', 'cui_str': 'Cyclooxygenase inhibitor'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0014440', 'cui_str': 'Enzyme measurement'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0014442', 'cui_str': 'Enzyme'}, {'cui': 'C0000379', 'cui_str': 'Methylenedioxyamphetamine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0234234', 'cui_str': 'Tender'}, {'cui': 'C0451521', 'cui_str': 'Swollen joint count'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0023775', 'cui_str': 'Lipid peroxidation'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}]",30.0,0.0288061,The baseline values of the SOD enzyme were significantly lower and MDA values were significantly elevated in patients randomized to the three treatment groups as compared to the control group ( P  < 0.05).,"[{'ForeName': 'Alok', 'Initials': 'A', 'LastName': 'Dixit', 'Affiliation': 'Department of Pharmacology, UP University of Medical Sciences, Etawah, Uttar Pradesh, India.'}, {'ForeName': 'Pinki', 'Initials': 'P', 'LastName': 'Pandey', 'Affiliation': 'Department of Pathology, UP University of Medical Sciences, Etawah, Uttar Pradesh, India.'}, {'ForeName': 'D C', 'Initials': 'DC', 'LastName': 'Dhasmana', 'Affiliation': 'Department of Pharmacology, Himalayan Institute of Medical Sciences, Dehradun, Uttarakhand, India.'}]",International journal of applied & basic medical research,['10.4103/ijabmr.IJABMR_344_19']
1920,33088776,Quest for the Ideal Nasal Pack in Post Operative Cases of Septo-Turbinoplasty: Study in a Tertiary Care Hospital.,"To compare the efficacies and post operative outcomes of patients with nasal packing with merocel, intranasal splints and merocel along with intra-nasal infant feeding tubes following septo-turbinoplasty, in patients with nasal obstruction secondary to septal deviation and inferior turbinate hypertrophy. A prospective study was done in 60 patients of symptomatic deviated nasal septum with inferior turbinate hypertrophy. Septoturbinoplasty was performed. Patients' nasal cavity was packed for 48 h after being randomly divided into 3 groups: (1) packing using merocel, (2) intra-intra nasal septal silicone splint, (3) packing using truncated merocel along with infant feeding tube. Patients were given a questionnaire 24 h post operatively and their reponse was analysed to compare nasal blockage, epistaxis, epiphora and headache. Pain on pack removal was recorded after 48 h. We found that merocel with infant feeding tube had better tolerance than plain merocel in almost all cases, with symptoms of nasal blockage, epiphora, headache and pain on pack removal being lesser than with plain merocel, and comparable to the results produced by nasal splints. Also the epistaxis control in merocel with infant feeding tube was better than with nasal splints. Truncated merocel with infant feeding tubes provides a suitable and cheap replacement for nasal splints which may not be affordable to a lot of patients, or may not in available in many settings. The results are superior to plain merocel and the control of post operative bleeding is better than with intra nasal splints.",2020,The results are superior to plain merocel and the control of post operative bleeding is better than with intra nasal splints.,"['60 patients of symptomatic deviated nasal septum with inferior turbinate hypertrophy', 'patients with nasal packing with merocel, intranasal splints and merocel along with intra-nasal infant feeding tubes following septo-turbinoplasty, in patients with nasal obstruction secondary to septal deviation and inferior turbinate hypertrophy']","['packing using merocel, (2) intra-intra nasal septal silicone splint, (3) packing using truncated merocel along with infant feeding tube']","['nasal blockage, epistaxis, epiphora and headache', 'nasal blockage, epiphora, headache and pain on pack removal', 'Pain on pack removal']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0264262', 'cui_str': 'Acquired deviated nasal septum'}, {'cui': 'C0225434', 'cui_str': 'Inferior nasal turbinate bone structure'}, {'cui': 'C0020564', 'cui_str': 'Hypertrophy'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0127601', 'cui_str': 'Merocel'}, {'cui': 'C1283141', 'cui_str': 'Intranasal splint'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C2945625', 'cui_str': 'Feeding tube'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C4087115', 'cui_str': 'Turbinoplasty'}, {'cui': 'C0027429', 'cui_str': 'Nasal obstruction'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}, {'cui': 'C0549397', 'cui_str': 'Deviated nasal septum'}]","[{'cui': 'C0184967', 'cui_str': 'Insertion of pack'}, {'cui': 'C0127601', 'cui_str': 'Merocel'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0027432', 'cui_str': 'Nasal septum structure'}, {'cui': 'C0450086', 'cui_str': 'Silicone splint'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0041281', 'cui_str': 'Tube feeding of patient'}]","[{'cui': 'C0027429', 'cui_str': 'Nasal obstruction'}, {'cui': 'C0014591', 'cui_str': 'Bleeding from nose'}, {'cui': 'C0152227', 'cui_str': 'Epiphora'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0184967', 'cui_str': 'Insertion of pack'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]",,0.0183488,The results are superior to plain merocel and the control of post operative bleeding is better than with intra nasal splints.,"[{'ForeName': 'A R', 'Initials': 'AR', 'LastName': 'Babu', 'Affiliation': 'Department of ENT, JSS Academy of Higher Education and Research (JSSAHER), Ramachandra Agrahara, Mysuru, Karnataka 570004 India.'}, {'ForeName': 'Kumar', 'Initials': 'K', 'LastName': 'Shankar De', 'Affiliation': 'Department of ENT, JSS Academy of Higher Education and Research (JSSAHER), Ramachandra Agrahara, Mysuru, Karnataka 570004 India.'}, {'ForeName': 'B G', 'Initials': 'BG', 'LastName': 'Prakash', 'Affiliation': 'Department of ENT, JSS Academy of Higher Education and Research (JSSAHER), Ramachandra Agrahara, Mysuru, Karnataka 570004 India.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Sreenivas Kamath', 'Affiliation': 'Department of ENT, JSS Academy of Higher Education and Research (JSSAHER), Ramachandra Agrahara, Mysuru, Karnataka 570004 India.'}]",Indian journal of otolaryngology and head and neck surgery : official publication of the Association of Otolaryngologists of India,['10.1007/s12070-020-01919-5']
1921,33088777,Efficacy and Comparison of Vestibular Rehabilitation Exercises on Quality of Life in Patients with Vestibular Disorders.,"Vertigo is the sensation of spinning or having one's surroundings spin about them. It represents about 25% of cases of occurrences of dizziness Yardley et al. (Br J Gen Pract 48(429):1131-1135, 1998). About 40% patients have peripheral vestibular dysfunction (Neuhauser in Curr Opin Neurol 20:40-46, 2007). Quality of life (QOL) is significantly impaired by vertigo (Patatas et al. in Braz J Otorhinolaryngol 75:387-394, 2009). To study the effect and compare vestibular exercises on QOL in patients with vestibular disorders. 120 individuals with vestibular disorders like acoustic neuroma, vestibular neuritis, labyrinthitis, Meniere's disease, vestibulopathy, ISSNHL and ototoxicity were included. Four groups adaptation exercises, habituation exercises, substitution exercises, and combined exercises were formed and 30 individuals were selected in each group randomly. Vestibular activities and participation (VAP) was administered before and after exercises to fulfill the aim. VAP Scale results revealed significant difference between pre and post treatment score in all groups, suggestive of positive effect on QOL in patients with vestibular disorders. Improvements in VAP Score between all groups were compared and significant difference was observed. Combined exercises group found to be best out of 4 exercises group.",2020,Improvements in VAP Score between all groups were compared and significant difference was observed.,"['patients with vestibular disorders', 'Patients with Vestibular Disorders', ""120 individuals with vestibular disorders like acoustic neuroma, vestibular neuritis, labyrinthitis, Meniere's disease, vestibulopathy, ISSNHL and ototoxicity were included""]","['adaptation exercises, habituation exercises, substitution exercises, and combined exercises', 'Vestibular Rehabilitation Exercises', 'vestibular exercises']","['Vestibular activities and participation (VAP', 'Quality of Life', 'Quality of life (QOL', 'peripheral vestibular dysfunction', 'VAP Score', 'VAP Scale']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042594', 'cui_str': 'Vestibular disorder'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0027859', 'cui_str': 'Acoustic neuroma'}, {'cui': 'C0751908', 'cui_str': 'Epidemic vertigo'}, {'cui': 'C0022890', 'cui_str': 'Labyrinthine disorder'}, {'cui': 'C0025281', 'cui_str': ""Ménière's disease""}, {'cui': 'C0235280', 'cui_str': 'Ototoxicity'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0013170', 'cui_str': 'Drug habituation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0200324', 'cui_str': 'Vestibular rehabilitation'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",120.0,0.0134671,Improvements in VAP Score between all groups were compared and significant difference was observed.,"[{'ForeName': 'Kumar Gourav', 'Initials': 'KG', 'LastName': 'Sharma', 'Affiliation': 'Department of ENT, Geetanjali Medical College and Hospital, Udaipur, Rajasthan 313001 India.'}, {'ForeName': 'Ashok Kumar', 'Initials': 'AK', 'LastName': 'Gupta', 'Affiliation': 'Department of ENT, Geetanjali Medical College and Hospital, Udaipur, Rajasthan 313001 India.'}]",Indian journal of otolaryngology and head and neck surgery : official publication of the Association of Otolaryngologists of India,['10.1007/s12070-020-01920-y']
1922,33089005,"Design, rationale, and baseline characteristics of a pilot randomized clinical trial of nicotine treatment for pulmonary sarcoidosis.","Introduction


Sarcoidosis is a systemic granulomatous disease of unknown cause afflicting young to middle-aged adults. The majority of patients with active pulmonary sarcoidosis complain of overwhelming fatigue, which often persists despite administration of immune-modulating drugs typically used to treat sarcoidosis. Nicotine offers an alternative to conventional treatments, which are associated with a spectrum of serious untoward effects, including diabetes mellitus, osteoporosis, bone marrow suppression, severe infections, cirrhosis. The described pilot randomized trial aims to provide preliminary data required to design subsequent Phase II/III trials to formally evaluate nicotine as a novel low-cost and highly-effective, safe treatment option for patients with active pulmonary sarcoidosis.
Methods


and Design: This is a randomized double-blind controlled trial of adults with confirmed pulmonary sarcoidosis, allocated in equal proportion to sustained release transdermal nicotine or placebo patch. The primary objective outcome is the improvement in forced vital capacity at study week 26 from baseline measurement. Secondary measures include lung texture score, and self-reported outcomes including the Fatigue Assessment Scale, the St George's Respiratory Questionnaire, and the Sarcoidosis Assessment Tool.
Discussion


Current therapies for active pulmonary sarcoidosis, remain either expensive and often with numerous side-effects, as with novel industry developed therapies, or with reduced quality of life, as with corticosteroids. Nicotine therapy provides promise as a safe, available, and cost-effective intervention strategy, which we expect to be acceptable to patients.
ClinicalTrialsgov


NCT02265874.",2020,"Secondary measures include lung texture score, and self-reported outcomes including the Fatigue Assessment Scale, the St George's Respiratory Questionnaire, and the Sarcoidosis Assessment Tool.
","['pulmonary sarcoidosis', 'patients with active pulmonary sarcoidosis', 'adults with confirmed pulmonary sarcoidosis, allocated in equal proportion to sustained release', 'unknown cause afflicting young to middle-aged adults']","['nicotine', 'Nicotine', 'transdermal nicotine or placebo patch', 'Nicotine therapy']","[""lung texture score, and self-reported outcomes including the Fatigue Assessment Scale, the St George's Respiratory Questionnaire, and the Sarcoidosis Assessment Tool"", 'improvement in forced vital capacity']","[{'cui': 'C0036205', 'cui_str': 'Pulmonary sarcoidosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0040652', 'cui_str': 'Transdermal route'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0449582', 'cui_str': 'With texture'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0036202', 'cui_str': 'Sarcoidosis'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}]",,0.104467,"Secondary measures include lung texture score, and self-reported outcomes including the Fatigue Assessment Scale, the St George's Respiratory Questionnaire, and the Sarcoidosis Assessment Tool.
","[{'ForeName': 'Erinn M', 'Initials': 'EM', 'LastName': 'Hade', 'Affiliation': 'Center for Biostatistics, Department of Biomedical Informatics, The Ohio State University, Columbus, OH, 43210, USA.'}, {'ForeName': 'Rachel M', 'Initials': 'RM', 'LastName': 'Smith', 'Affiliation': 'Center for Biostatistics, Department of Biomedical Informatics, The Ohio State University, Columbus, OH, 43210, USA.'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Culver', 'Affiliation': 'Department of Pulmonary Medicine, Respiratory Institute, Cleveland Clinic, Cleveland, OH, 44195, USA.'}, {'ForeName': 'Elliott D', 'Initials': 'ED', 'LastName': 'Crouser', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, Department of Internal Medicine, The Ohio State University, Columbus, OH, 43210, USA.'}]",Contemporary clinical trials communications,['10.1016/j.conctc.2020.100669']
1923,33089024,Intranasal midazolam sedation as an effective sedation route in pediatric patients for radiologic imaging in the emergency ward: A single-blind randomized trial.,"OBJECTIVES


Prevention and reduction of pain, anxiety, and fear during medical procedures is one of the most important factors that should be considered in pediatric emergencies. The aim of this study was to compare the efficacy of oral versus intranasal midazolam in sedation during radiologic imaging in the largest province of Iran, Kerman.
MATERIALS AND METHODS


Eighty children were enrolled in this single-blind clinical trial based on convenience sampling and were divided into two groups receiving 0.5 mg/kg midazolam in oral route administration and 0.2 mg/kg midazolam in intranasal route administration. Finally, 75 patients remained for evaluating medication acceptability, sedation level, onset time of sedation, additional sedative dose, adverse effects of sedation, and provider satisfaction.
RESULTS


Children in the intranasal group accepted medication more easily (89.8% vs. 36.9%;  P  ≤ 0.001), while these children received a lower sedation dose, but the sedation level in both methods was similar ( P  = 0.72). Our findings showed that children in the intranasal sedation group had a faster onset of sedation compared to the oral group (17.94 ± 8.99 vs. 34.50 ± 11.45;  P  ≤ 0.001). The frequency of midazolam side effects had no difference between the groups (29.7% vs. 15.8%;  P  = 0.15).
CONCLUSION


Intranasal midazolam with a lower sedation dose induces a faster onset and better acceptance. Intranasal midazolam can be used as an effective sedative method for pediatric patients, especially in emergency wards.",2020,"RESULTS


Children in the intranasal group accepted medication more easily (89.8% vs. 36.9%;  P  ≤ 0.001), while these children received a lower sedation dose, but the sedation level in both methods was similar ( P  = 0.72).","['largest province of Iran, Kerman', 'pediatric patients for radiologic imaging in the emergency ward', 'pediatric patients, especially in emergency wards', 'Eighty children']","['Intranasal midazolam', 'midazolam in oral route administration and 0.2 mg/kg midazolam', 'intranasal midazolam', 'Intranasal midazolam sedation']","['pain, anxiety, and fear', 'sedation level', 'medication acceptability, sedation level, onset time of sedation, additional sedative dose, adverse effects of sedation, and provider satisfaction', 'faster onset of sedation', 'frequency of midazolam side effects']","[{'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034599', 'cui_str': 'Radiology - specialty'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C1527415', 'cui_str': 'Oral route'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0449244', 'cui_str': 'Time of onset'}, {'cui': 'C0020592', 'cui_str': 'HYPNOTICS AND SEDATIVES'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}]",80.0,0.108177,"RESULTS


Children in the intranasal group accepted medication more easily (89.8% vs. 36.9%;  P  ≤ 0.001), while these children received a lower sedation dose, but the sedation level in both methods was similar ( P  = 0.72).","[{'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Mayel', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Mehdi Ahmadi', 'Initials': 'MA', 'LastName': 'Nejad', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Mehdi Sadeghi', 'Initials': 'MS', 'LastName': 'Khabaz', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Maliheh Sadat', 'Initials': 'MS', 'LastName': 'Bazrafshani', 'Affiliation': 'Student Research Committee, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Ehsan', 'Initials': 'E', 'LastName': 'Mohajeri', 'Affiliation': 'Department of Pharmaceutics, Faculty of Pharmacy, Kerman University of Medical Sciences, Kerman, Iran.'}]",Turkish journal of emergency medicine,['10.4103/2452-2473.297461']
1924,33089033,Effectiveness of proprioceptive training versus conventional exercises on postural sway in patients with early knee osteoarthritis - A randomized controlled trial protocol.,"Introduction


In recent times, 'early osteoarthritis' (EOA) has achieved recognition as a disease entity. The importance of defining EOA is in the fact that a variety of joint preservation treatments are available. Development of the sense of proprioception is a known vital element of most exercise rehabilitation programmes. Postural sways have been found to be prevalent in arthritic patients. It follows therefore that correction of early postural aberrations should help patients with EOA. The current study aims to determine the effectiveness of such proprioceptive training versus conventional exercises in patients with EOA.
Method


This study is a randomized controlled trial. A total of 100 participants between the age of 20-45 years will be recruited. Participants will be randomly assigned to conventional or interventional group. Participants in both the groups will receive 12 session of treatment over a period of four weeks. Outcome measure considered are center of pressure excursion, joint position sense, hand held dynamometer, visual analog scale and knee injury and osteoarthritis Outcome Score for functional outcome.
Results


Data collected will be analyzed by mean, SD and 2 factor ANOVA for repeated measure, followed by Bonferroni post hoc analysis. Data will be analyzed using SPSS package version 17.0, p < 0.05 will be considered as significant.
Conclusion


The authors hope to determine whether proprioceptive training improves outcome better than conventional exercise therapy and hope to contribute to an improved targeted treatment for patients with Early osteoarthritis.",2020,"Outcome measure considered are center of pressure excursion, joint position sense, hand held dynamometer, visual analog scale and knee injury and osteoarthritis Outcome Score for functional outcome.
","['patients with early knee osteoarthritis ', 'patients with Early osteoarthritis', 'patients with EOA', '100 participants between the age of 20-45\xa0years will be recruited', 'arthritic patients']","['proprioceptive training versus conventional exercises', 'proprioceptive training', 'conventional exercise therapy']","['center of pressure excursion, joint position sense, hand held dynamometer, visual analog scale and knee injury and osteoarthritis Outcome Score for functional outcome', 'postural sway']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}]","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0423561', 'cui_str': 'Joint position sense'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0675390', 'cui_str': 'ARID1A protein, human'}, {'cui': 'C0180572', 'cui_str': 'Dynamometer'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C3476088', 'cui_str': 'Knee Injury and Osteoarthritis Outcome Score'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205278', 'cui_str': 'Postural'}]",100.0,0.0965517,"Outcome measure considered are center of pressure excursion, joint position sense, hand held dynamometer, visual analog scale and knee injury and osteoarthritis Outcome Score for functional outcome.
","[{'ForeName': 'Ashish', 'Initials': 'A', 'LastName': 'John Prabhakar', 'Affiliation': 'Department of Physiotherapy, Kasturba Medical College, Mangalore, Manipal Academy of Higher Education, India.'}, {'ForeName': 'Abraham M', 'Initials': 'AM', 'LastName': 'Joshua', 'Affiliation': 'Department of Physiotherapy, Kasturba Medical College, Mangalore, Manipal Academy of Higher Education, India.'}, {'ForeName': 'Srikanth', 'Initials': 'S', 'LastName': 'Prabhu', 'Affiliation': 'Department of Computer Science & Engineering, Manipal Institute of Technology, Manipal Academy of Higher Education, Manipal, India.'}, {'ForeName': 'Yogeesh', 'Initials': 'Y', 'LastName': 'Dattakumar Kamat', 'Affiliation': 'Consultant Knee & Hip Surgeon, KMC Hospital, Ambedkar Circle, Mangaluru. Adjunct Faculty, MAHE, India.'}]",International journal of surgery protocols,['10.1016/j.isjp.2020.09.002']
1925,33089081,"Comparison of effectiveness of different kinesiological taping techniques in patients with chronic low back pain: A double-blind, randomized-controlled study.","Objectives


This study aims to investigate the effects of kinesiological taping (KT) method combined with physiotherapy modalities and exercise therapy on the severity of pain, range of lumbar motion, and degree of disability.
Patients and methods


Between November 2015 and November 2016, a total of 125 patients (63 males, 62 females; mean age 45 years; range, 20 to 65 years) who were diagnosed with chronic non-specific low back pain were included in this double-blind, randomized, placebo-controlled study. The patients were randomly assigned to four groups. All groups received the same physiotherapy modalities and exercise therapy. Group 1 received physiotherapy modalities and exercise therapy alone; Group 2 received additional sham KT; Group 3 received additional KT with a space correction technique; and Group 4 received additional KT with a fascia correction technique. Kinesiological taping was applied for three weeks with five-day intervals and four times in total. The patients were evaluated at baseline (Day 0), at the end of the treatment (Day 21), and on Day 51. Pain severity using the Visual Analog Scale (VAS), ranges of lumbar motion using the fingertip-to-floor distances and modified lumbar Schober test, and the degree of disability using the Oswestry Disability Index (ODI) and Roland Morris Disability Questionnaire (RMDQ) were evaluated.
Results


We found a significant difference among the groups in terms of VAS motion T0-51 changes (p<0.05). There was also a significant difference among the groups in terms of T0-21 and T0-51 changes in the ODI and RMDQ (p<0.05).
Conclusion


Our study results suggest that KT ensures reduction in pain and disability, irrespective of the technique of taping, with sustainable short-term effects following the end of the treatment.",2020,"There was also a significant difference among the groups in terms of T0-21 and T0-51 changes in the ODI and RMDQ (p<0.05).
","['Patients and methods\n\n\nBetween November 2015 and November 2016, a total of 125 patients (63 males, 62 females; mean age 45 years; range, 20 to 65 years) who were diagnosed with chronic non-specific low back pain', 'patients with chronic low back pain']","['additional KT with a space correction technique; and Group 4 received additional KT with a fascia correction technique', 'kinesiological taping techniques', 'placebo', 'KT', 'physiotherapy modalities and exercise therapy', 'Kinesiological taping', 'kinesiological taping (KT) method combined with physiotherapy modalities and exercise therapy', 'physiotherapy modalities and exercise therapy alone; Group 2 received additional sham KT']","['pain and disability', 'Pain severity using the Visual Analog Scale (VAS), ranges of lumbar motion using the fingertip-to-floor distances and modified lumbar Schober test, and the degree of disability using the Oswestry Disability Index (ODI) and Roland Morris Disability Questionnaire (RMDQ', 'severity of pain, range of lumbar motion, and degree of disability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}]","[{'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0441876', 'cui_str': 'Group 4'}, {'cui': 'C0015641', 'cui_str': 'Fascial'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0729895', 'cui_str': 'Tip of finger'}, {'cui': 'C0016249', 'cui_str': 'Walking surface of room'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0430750', 'cui_str': 'Modified Schober test'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",125.0,0.103771,"There was also a significant difference among the groups in terms of T0-21 and T0-51 changes in the ODI and RMDQ (p<0.05).
","[{'ForeName': 'Alper', 'Initials': 'A', 'LastName': 'Mengi', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Gaziosmanpaşa Taksim Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Şenay', 'Initials': 'Ş', 'LastName': 'Özdolap', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Bülent Ecevit University Faculty of Medicine, Zonguldak, Turkey.'}, {'ForeName': 'Tuğçe', 'Initials': 'T', 'LastName': 'Köksal', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Bülent Ecevit University Faculty of Medicine, Zonguldak, Turkey.'}, {'ForeName': 'Fürüzan', 'Initials': 'F', 'LastName': 'Köktürk', 'Affiliation': 'Department of Biostatistics, Bülent Ecevit University Faculty of Medicine, Zonguldak, Turkey.'}, {'ForeName': 'Selda', 'Initials': 'S', 'LastName': 'Sarıkaya', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Bülent Ecevit University Faculty of Medicine, Zonguldak, Turkey.'}]",Turkish journal of physical medicine and rehabilitation,['10.5606/tftrd.2020.3712']
1926,33089083,"The effect of static and dynamic core exercises on dynamic balance, spinal stability, and hip mobility in female office workers.","Objectives


This study aims to compare the effect of static and dynamic core exercises in terms of dynamic balance, spinal stability, and hip mobility in female office workers.
Patients and methods


Between May 2018 and June 2018, a total of 34 women (mean age 36.4±6.5 years; range, 28 to 54 years) who worked for a bank and exercised in the fitness center of the work place were recruited. The women were divided into two groups including 17 women in each as static and dynamic core groups and administered sessions of 20 to 30 min twice a week for six weeks. Both groups were tested for dynamic balance (Y-balance test), spinal stability (functional reach test), and hip mobility (active flexion and extension) before and after six weeks of exercise.
Results


A statistically significant improvement was found in both groups between the pre- and post-test results in terms of spinal stability, hip mobility, and dynamic balance (p<0.05). The only exception was the right and left leg anterior balance in the static core group. Dynamic core exercises seemed to be more effective than static core exercises in improving the right and left leg anterior balance. There were no statistically significant differences between the groups in terms of spinal stability, hip mobility, and dynamic balance according to the mean absolute change (p>0.05).
Conclusion


Our study results indicate that both types of exercises are effective in improving dynamic balance, spinal stability, and hip mobility in female office workers. Therefore, the expected benefits from core exercises are to enhance dynamic balance, spinal stability, and hip mobility. Female workers can perform both types of exercises safely and effectively.",2020,"A statistically significant improvement was found in both groups between the pre- and post-test results in terms of spinal stability, hip mobility, and dynamic balance (p<0.05).","['Female workers', 'female office workers', 'Patients and methods\n\n\nBetween May 2018 and June 2018, a total of 34 women (mean age 36.4±6.5 years; range, 28 to 54 years) who worked for a bank and exercised in the fitness center of the work place were recruited']",['static and dynamic core exercises'],"['right and left leg anterior balance', 'dynamic balance, spinal stability, and hip mobility', 'spinal stability, hip mobility, and dynamic balance', 'spinal stability, hip mobility, and dynamic balance (p<0.05', 'dynamic balance (Y-balance test), spinal stability (functional reach test), and hip mobility (active flexion and extension']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0442598', 'cui_str': 'Bank'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0600623', 'cui_str': 'Fitness Centers'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}]","[{'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1998271', 'cui_str': 'Functional reach test'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0231448', 'cui_str': 'Extension'}]",34.0,0.0180472,"A statistically significant improvement was found in both groups between the pre- and post-test results in terms of spinal stability, hip mobility, and dynamic balance (p<0.05).","[{'ForeName': 'Emre', 'Initials': 'E', 'LastName': 'Örgün', 'Affiliation': 'Department Sports Physiology, Okan University, Health Sciences Institute, Istanbul, Turkey.'}, {'ForeName': 'Cem', 'Initials': 'C', 'LastName': 'Kurt', 'Affiliation': 'Trakya University, Kırkpınar School of Physical Education and Sport, Edirne, Turkey.'}, {'ForeName': 'İlbilge', 'Initials': 'İ', 'LastName': 'Özsu', 'Affiliation': 'Uşak University, Sports Science Faculty, Uşak, Turkey.'}]",Turkish journal of physical medicine and rehabilitation,['10.5606/tftrd.2020.4317']
1927,33089087,"Comparing the efficiency of ultrasound, ketoprofen, and mucopolysaccharide polysulfate phonophoresis in the treatment of lateral epicondylitis: A randomized-controlled clinical study.","Objectives


In this study, we aimed to compare the efficiency of ultrasound, mucopolysaccharide polysulfate phonophoresis, ketoprofen phonophoresis and exercise combinations in terms of pain, functionality, disability, and strength in patients with lateral epicondylitis (LE).
Patients and methods


This prospective, parallel-group, randomized-controlled clinical study included a total of 60 patients (42 males, 18 females; mean age 38.08 years; range, 21 to 50 years) with LE between April 2016 and October 2017. The patients were equally randomized into four groups based on the time of admission to the outpatient clinic. The Visual Analog Scale (VAS), painless weight lifting, the Patient- Rated Tennis Elbow Evaluation (PRTEE), and Quick Disabilities of Arm, Shoulder and Hand (QuickDASH) were used to measure the outcomes. The measurements were performed at baseline, at the end of 10 daily sessions, and after a six-week follow-up period.
Results


The resting VAS scores in the ketoprofen phonophoresis group and lifted weights in the MPS and ketoprofen phonophoresis groups showed a significant improvement both after 10 days of treatment and at six-week follow-up visits (p<0.001). In the QuickDASH model, there was no significant improvement in the control group after 10 days of treatment (p>0.05); however, a significant improvement was observed after six weeks (p<0.001). Except for these variables, significant improvements were found in all groups for all variables at six-week follow-up (p<0.05). However, improvements were similar in all groups (p>0.05).
Conclusion


Based on our study results, for LE patients who are unable to adhere to exercise and splint use and are given a physical treatment plan, inclusion of ketoprofen and MPS phonophoresis in the treatment program may yield additional benefits in their daily living activities, functionality, and working life.",2020,"Except for these variables, significant improvements were found in all groups for all variables at six-week follow-up (p<0.05).","['60 patients (42 males, 18 females; mean age 38.08 years; range, 21 to 50 years) with LE between April 2016 and October 2017', 'patients with lateral epicondylitis (LE', 'lateral epicondylitis']","['ultrasound, ketoprofen, and mucopolysaccharide polysulfate phonophoresis', 'ketoprofen phonophoresis', 'ketoprofen and MPS phonophoresis', 'ultrasound, mucopolysaccharide polysulfate phonophoresis, ketoprofen phonophoresis and exercise combinations']","['Visual Analog Scale (VAS), painless weight lifting, the Patient', 'lifted weights', 'Rated Tennis Elbow Evaluation (PRTEE), and Quick Disabilities of Arm, Shoulder and Hand (QuickDASH', 'pain, functionality, disability, and strength', 'resting VAS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0039516', 'cui_str': 'Lateral epicondylitis'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0022635', 'cui_str': 'Ketoprofen'}, {'cui': 'C0066923', 'cui_str': 'mucopolysaccharide polysulfate'}, {'cui': 'C0031582', 'cui_str': 'Phonophoresis therapy'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0234226', 'cui_str': 'Painless'}, {'cui': 'C0043095', 'cui_str': 'Weight Lifting'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0039516', 'cui_str': 'Lateral epicondylitis'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C1997924', 'cui_str': 'Disability of arm'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",60.0,0.0209475,"Except for these variables, significant improvements were found in all groups for all variables at six-week follow-up (p<0.05).","[{'ForeName': 'Sevil', 'Initials': 'S', 'LastName': 'Okan', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Tokat State Hospital, Tokat, Turkey.'}, {'ForeName': 'Ayla', 'Initials': 'A', 'LastName': 'Çağlıyan Türk', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Hitit University Faculty of Medicine, Çorum, Turkey.'}]",Turkish journal of physical medicine and rehabilitation,['10.5606/tftrd.2020.4433']
1928,33089088,"Occupational therapy assessment and treatment approach in patients with subacute and chronic stroke: A single-blind, prospective, randomized clinical trial.","Objectives


The aim of this study was to examine the effects of occupational therapy (OT) combined with standard rehabilitation (SR) on the activities of daily living, quality of life, and psychological symptoms of hemiplegic patients.
Patients and methods


Between August 2014 and February 2016, a total of 35 hemiplegic patients with post-diagnostic periods (19 males, 16 females; mean age 58.3 years; range 37 to 77 years) were included. The patients were randomized into two groups as OT+SR group (n=17) and SR only group (n=18). The study was completed by 16 patients in each group. The patients in the OT group were given 45-min SR five days a week plus 45-min OT three days a week over an eight-week period, while the patients in the SR group received SR only (of the same duration and frequency as the OT group). The patients were assessed at enrolment (pre-treatment), and again after eight weeks of treatment using the Pinch and Grip Strength and the Purdue Pegboard tests, Global Daily Living Activities Scale, Performance Assessment of Self-care Skills (PASS), Nottingham Extended Activities of Daily Living (NEADL) Scale, Quality of Life Short Form (SF-36) Questionnaire, and Hospital Anxiety and Depression Scale (HAD) for their psychological state.
Results


Significant improvements were observed in within-group scores for PASS, Pinch and Grip Strength Test, NEADL Scale, and Purdue Pegboard test (p<0.05). After treatment, a significant increase was found in the SF-36 physical function, general health and physical total in-group scores of the OT group, whereas a significant increase was observed only in the physical total scores of the SR group (p<0.05). There was no significant improvement in the HAD scores within both groups (p>0.05). Inter-group comparisons revealed a further significant improvement in PASS instrumental daily activity index-physical subscale and Purdue Pegboard Test scores of the OT group (p<0.05). However, there was no significant difference in PASS activity, self-care and instrumental daily activity cognitive subscale, SF-36, HAD and hand grip and pinch strength scores between the groups (p>0.05).
Conclusion


Occupational therapy combined with SR applications has a beneficial impact on certain daily living activities and hand functions. Occupational therapy does not have any additional benefits on the quality of life, pinch and grip strength, and the psychological state.",2020,"Results


Significant improvements were observed in within-group scores for PASS, Pinch and Grip Strength Test, NEADL Scale, and Purdue Pegboard test (p<0.05).","['hemiplegic patients', 'patients with subacute and chronic stroke', '16 patients in each group', 'Patients and methods\n\n\nBetween August 2014 and February 2016, a total of 35 hemiplegic patients with post-diagnostic periods (19 males, 16 females; mean age 58.3 years; range 37 to 77 years']","['Occupational therapy assessment and treatment approach', 'OT+SR', 'occupational therapy (OT) combined with standard rehabilitation (SR', 'Occupational therapy combined with SR applications']","['PASS instrumental daily activity index-physical subscale and Purdue Pegboard Test scores', 'physical total scores', 'quality of life, pinch and grip strength', 'Pinch and Grip Strength and the Purdue Pegboard tests, Global Daily Living Activities Scale, Performance Assessment of Self-care Skills (PASS), Nottingham Extended Activities of Daily Living (NEADL', 'PASS, Pinch and Grip Strength Test, NEADL Scale, and Purdue Pegboard test (p<0.05', 'HAD scores', 'PASS activity, self-care and instrumental daily activity cognitive subscale, SF-36, HAD and hand grip and pinch strength scores', 'Scale, Quality of Life Short Form (SF-36) Questionnaire, and Hospital Anxiety and Depression Scale (HAD) for their psychological state', 'activities of daily living, quality of life, and psychological symptoms', 'SF-36 physical function, general health and physical total']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205365', 'cui_str': 'Subacute'}, {'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]","[{'cui': 'C1444296', 'cui_str': 'Occupational therapy assessment'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0521127', 'cui_str': 'Occupational'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C1318464', 'cui_str': 'Occupational therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C1161151', 'cui_str': 'Assessment of self care'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0204462', 'cui_str': 'Purdue pegboard test'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0418416', 'cui_str': 'Pinched'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0430765', 'cui_str': 'Manual muscle-testing of hand'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C1293900', 'cui_str': 'Hand grip'}, {'cui': 'C1720876', 'cui_str': 'Pinch Strength'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0233397', 'cui_str': 'Psychological symptom'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}]",35.0,0.0158261,"Results


Significant improvements were observed in within-group scores for PASS, Pinch and Grip Strength Test, NEADL Scale, and Purdue Pegboard test (p<0.05).","[{'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Eroğlu', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Medicine Faculty of Ege University, Izmir, Turkey.'}, {'ForeName': 'Hale', 'Initials': 'H', 'LastName': 'Karapolat', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Medicine Faculty of Ege University, Izmir, Turkey.'}, {'ForeName': 'Funda', 'Initials': 'F', 'LastName': 'Atamaz', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Medicine Faculty of Ege University, Izmir, Turkey.'}, {'ForeName': 'Göksel', 'Initials': 'G', 'LastName': 'Tanıgör', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Medicine Faculty of Ege University, Izmir, Turkey.'}, {'ForeName': 'Yeşim', 'Initials': 'Y', 'LastName': 'Kirazlı', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Medicine Faculty of Ege University, Izmir, Turkey.'}]",Turkish journal of physical medicine and rehabilitation,['10.5606/tftrd.2020.4321']
1929,33089092,A comparison of dry needling and kinesiotaping therapies in myofascial pain syndrome: A randomized clinical study.,"Objectives


This study aims to compare the effectiveness of dry needling (DN) and kinesiotaping (KT) therapies on pain, quality of life, depression, and physical function in the treatment of myofascial pain syndrome (MPS).
Patients and methods


The study included a total of 60 patients (4 males, 56 females; mean age 31.2±9.8 years; range, 18 to 56 years) diagnosed with MPS between January 2014 and June 2014. The patients were randomly divided into two treatment groups: the DN group (n=30) and KT group (n=30). Both groups performed stretching and postural exercises. The scales used for measurements were the Visual Analog Scale (VAS) for pain, a pressure algometer for the pressure-pain threshold, the Short Form-36 (SF-36) for the quality of life, Beck Depression Inventory (BDI) for depression, and the Neck Pain and Disability Scale (NPDS) for physical function. The patients were evaluated by a single assessor three times: pre-treatment, at the end of the treatment, and two months after the treatment.
Results


Both DN and KT provided significant improvements for all baseline measurements (VAS, pressure pain threshold, all subscales of SF-36, BDI, and NPDS scores) at the end of the treatment and two months after the treatment (p<0.05). However, there was no significant difference between the groups in all measurements (p>0.05).
Conclusion


Kinesiotaping is as an effective method as DN in the treatment of MPS. It can be served as a non-invasive alternative to patients with needle phobia.",2020,"Both DN and KT provided significant improvements for all baseline measurements (VAS, pressure pain threshold, all subscales of SF-36, BDI, and NPDS scores) at the end of the treatment and two months after the treatment (p<0.05).","['60 patients (4 males, 56 females; mean age 31.2±9.8 years; range, 18 to 56 years) diagnosed with MPS between January 2014 and June 2014', 'patients with needle phobia', 'myofascial pain syndrome', 'myofascial pain syndrome (MPS']","['dry needling (DN) and kinesiotaping (KT) therapies', 'dry needling and kinesiotaping therapies', 'stretching and postural exercises']","['Visual Analog Scale (VAS) for pain, a pressure algometer for the pressure-pain threshold, the Short Form-36 (SF-36) for the quality of life, Beck Depression Inventory (BDI) for depression, and the Neck Pain and Disability Scale (NPDS) for physical function', 'baseline measurements (VAS, pressure pain threshold, all subscales of SF-36, BDI, and NPDS scores', 'pain, quality of life, depression, and physical function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0338906', 'cui_str': 'Needle phobia'}]","[{'cui': 'C0394648', 'cui_str': 'Dry needle acupuncture'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0150716', 'cui_str': 'Postural exercises'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",60.0,0.029348,"Both DN and KT provided significant improvements for all baseline measurements (VAS, pressure pain threshold, all subscales of SF-36, BDI, and NPDS scores) at the end of the treatment and two months after the treatment (p<0.05).","[{'ForeName': 'Nurdan', 'Initials': 'N', 'LastName': 'Yılmaz', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Medicine Faculty of Gaziosmanpaşa University, Tokat, Turkey.'}, {'ForeName': 'Akın', 'Initials': 'A', 'LastName': 'Erdal', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Medicine Faculty of Atatürk University, Erzurum, Turkey.'}, {'ForeName': 'Osman', 'Initials': 'O', 'LastName': 'Demir', 'Affiliation': 'Department of Biostatistics, Medicine Faculty of Gaziosmanpaşa University, Tokat, Turkey.'}]",Turkish journal of physical medicine and rehabilitation,['10.5606/tftrd.2020.3917']
1930,33089127,"A developmental and sequenced one-to-one educational intervention (DS1-EI) for autism spectrum disorder and intellectual disability: A three-year randomized, single-blind controlled trial.","Background


Children with autism spectrum disorder (ASD) and intellectual disability (ID) are an understudied population whose school inclusion is challenging.
Methods


We assessed the effects of ""Developmental and Sequenced one-to-one Educational Intervention"" (DS1-EI), a ten-hour-per-week adapted instruction programme for five- to nine-year-old children with ASD and ID treated in outpatient health care institutions. A single-blind multisite randomized controlled trial was conducted to compare DS1-EI given for three years with treatment as usual (TAU)(trial registration numbers: ANSM130282B-31 (April 16, 2013) and ACTRN12616000592448). The primary outcome was the change in the psycho-educational profile (PEP). Secondary variables included the Childhood Autism Rating Scale (CARS), Autism Diagnostic Interview-Revised (ADI-R), Vineland Adaptive Behaviour Scale-II (VABS-II), Children's Global Assessment Scale (CGAS) and annual assessment of educational achievement. Statistical analyses used linear mixed models.
Findings


Seventy-two participants with severe ASD and ID were recruited. Intention-to-treat and per-protocol analyses showed no significant group*time interaction for the PEP, CARS, ADI-R, VABS-II and CGAS but a significant effect for educational achievement with a better improvement in the DS1-EI group. At the 36-month time point, more DS1-EI children were included in mainstream classrooms. Additional analyses using multivariate models taking into account moderating variables at the baseline (e.g., Developmental Quotient) confirmed that DS1-EI had a significant effect on educational outcomes.
Interpretation


DS1-EI did not improve communication or social skills in children with ASD and ID compared with TAU. However, DS1-EI enhanced school skills in four domains (language, mathematics, inter modality, and school autonomy) favouring inclusion in mainstream classrooms more than TAU. Providing such adapted instruction is feasible and should be encouraged.
Funding


CNSA; Fondation Bettencourt-Schueller; Fondation EDF.",2020,"Intention-to-treat and per-protocol analyses showed no significant group*time interaction for the PEP, CARS, ADI-R, VABS-II and CGAS but a significant effect for educational achievement with a better improvement in the DS1-EI group.","['\n\n\nChildren with autism spectrum disorder (ASD) and intellectual disability (ID', 'Findings\n\n\nSeventy-two participants with severe ASD and ID were recruited', 'five- to nine-year-old children with ASD and ID treated in outpatient health care institutions', 'children with ASD', 'autism spectrum disorder and intellectual disability']","['Developmental and Sequenced one-to-one Educational Intervention"" (DS1-EI', 'educational intervention (DS1-EI']","['PEP, CARS, ADI-R, VABS-II and CGAS', ""Childhood Autism Rating Scale (CARS), Autism Diagnostic Interview-Revised (ADI-R), Vineland Adaptive Behaviour Scale-II (VABS-II), Children's Global Assessment Scale (CGAS) and annual assessment of educational achievement"", 'change in the psycho-educational profile (PEP', 'communication or social skills']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C3714756', 'cui_str': 'Intellectual disability'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C4319632', 'cui_str': '72'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}]","[{'cui': 'C0458003', 'cui_str': 'Developmental'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0031642', 'cui_str': 'Phosphoenolpyruvate'}, {'cui': 'C0004381', 'cui_str': 'Automobile'}, {'cui': 'C0077959', 'cui_str': 'VAB II protocol'}, {'cui': 'C0055633', 'cui_str': 'Chromogranin A'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0582680', 'cui_str': 'Vineland adaptive behavior scales'}, {'cui': 'C3472495', 'cui_str': ""Children's global assessment scale""}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0013658', 'cui_str': 'Educational achievement'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0679005', 'cui_str': 'Social Abilities'}]",72.0,0.103811,"Intention-to-treat and per-protocol analyses showed no significant group*time interaction for the PEP, CARS, ADI-R, VABS-II and CGAS but a significant effect for educational achievement with a better improvement in the DS1-EI group.","[{'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Saint-Georges', 'Affiliation': 'Institut des Systèmes Intelligents et de Robotiques, Sorbonne Université, 75005, Paris, France.'}, {'ForeName': 'Maryse', 'Initials': 'M', 'LastName': 'Pagnier', 'Affiliation': ""Département de Psychiatrie de l'Enfant et de l'Adolescent, APHP, Groupe Hospitalier Pitié-Salpêtrière et Sorbonne Université, 47 bd de l'Hôpital, 75013 Paris, France.""}, {'ForeName': 'Zeineb', 'Initials': 'Z', 'LastName': 'Ghattassi', 'Affiliation': ""Département de Psychiatrie de l'Enfant et de l'Adolescent, APHP, Groupe Hospitalier Pitié-Salpêtrière et Sorbonne Université, 47 bd de l'Hôpital, 75013 Paris, France.""}, {'ForeName': 'Annick', 'Initials': 'A', 'LastName': 'Hubert-Barthelemy', 'Affiliation': ""Département de Psychiatrie de l'Enfant et de l'Adolescent, APHP, Groupe Hospitalier Pitié-Salpêtrière et Sorbonne Université, 47 bd de l'Hôpital, 75013 Paris, France.""}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Tanet', 'Affiliation': ""Département de Psychiatrie de l'Enfant et de l'Adolescent, APHP, Groupe Hospitalier Pitié-Salpêtrière et Sorbonne Université, 47 bd de l'Hôpital, 75013 Paris, France.""}, {'ForeName': 'Marie-Noëlle', 'Initials': 'MN', 'LastName': 'Clément', 'Affiliation': 'Hôpital de jour André Boulloche, Association Cerep-Phymentin, 56 rue du Faubourg Poissonnière, 75010 Paris, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Soumille', 'Affiliation': ""Association Régionale pour l'Intégration, 26 rue Saint Sébastien, 13006 Marseille, France.""}, {'ForeName': 'Graciela C', 'Initials': 'GC', 'LastName': 'Crespin', 'Affiliation': ""Association Programme de Recherche et d'Etudes sur l'Autisme, 7, Square Dunois, 75013 Paris, France.""}, {'ForeName': 'Hugues', 'Initials': 'H', 'LastName': 'Pellerin', 'Affiliation': ""Département de Psychiatrie de l'Enfant et de l'Adolescent, APHP, Groupe Hospitalier Pitié-Salpêtrière et Sorbonne Université, 47 bd de l'Hôpital, 75013 Paris, France.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cohen', 'Affiliation': 'Institut des Systèmes Intelligents et de Robotiques, Sorbonne Université, 75005, Paris, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",EClinicalMedicine,['10.1016/j.eclinm.2020.100537']
1931,33089201,Auditory Countermeasures for Sleep Inertia: Exploring the Effect of Melody and Rhythm in an Ecological Context.,"Sleep inertia is a decline in cognition one may experience upon and following awakening. A recent study revealed that an alarm sound perceived as melodic by participants displayed a significant relationship to reports of reductions in perceived sleep inertia. This current research builds on these findings by testing the effect melody and rhythm exhibit on sleep inertia for subjects awakening in their habitual environments. Two test Groups (A and B;  N  = 10 each) completed an online psychomotor experiment and questionnaire in two separate test sessions immediately following awakening from nocturnal sleep. Both groups responded to a control stimulus in the first session, while in the second session, Group A experienced a melodic treatment, and Group B a rhythmic treatment. The results show that the melodic treatment significantly decreased attentional lapses, false starts, and had a significantly improved psychomotor vigilance test (PVT) performance score than the control. There was no significant result for reaction time or response speed. Additionally, no significant difference was observed for all PVT metrics between the control-rhythmic conditions. The results from this analysis support melodies' potential to counteract symptoms of sleep inertia by the observed increase in participant vigilance following waking from nocturnal sleep.",2020,"The results show that the melodic treatment significantly decreased attentional lapses, false starts, and had a significantly improved psychomotor vigilance test (PVT) performance score than the control.","['subjects awakening in their habitual environments', 'Sleep Inertia']","['online psychomotor experiment and questionnaire', 'melodic treatment, and Group B a rhythmic treatment']","['PVT metrics', 'attentional lapses, false starts', 'psychomotor vigilance test (PVT) performance score', 'reaction time or response speed']","[{'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C1963765', 'cui_str': 'Sleep inertia'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}]","[{'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0205237', 'cui_str': 'False'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0043012', 'cui_str': 'Wakefulness'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}]",,0.0195983,"The results show that the melodic treatment significantly decreased attentional lapses, false starts, and had a significantly improved psychomotor vigilance test (PVT) performance score than the control.","[{'ForeName': 'Stuart J', 'Initials': 'SJ', 'LastName': 'McFarlane', 'Affiliation': 'School of Media and Communication, RMIT University, Melbourne 3001, Australia; jair.garcia@rmit.edu.au (J.E.G.); adrian.dyer@rmit.edu.au (A.G.D.).'}, {'ForeName': 'Jair E', 'Initials': 'JE', 'LastName': 'Garcia', 'Affiliation': 'School of Media and Communication, RMIT University, Melbourne 3001, Australia; jair.garcia@rmit.edu.au (J.E.G.); adrian.dyer@rmit.edu.au (A.G.D.).'}, {'ForeName': 'Darrin S', 'Initials': 'DS', 'LastName': 'Verhagen', 'Affiliation': 'School of Design, RMIT University, Melbourne 3001, Australia; darrin.verhagen@rmit.edu.au.'}, {'ForeName': 'Adrian G', 'Initials': 'AG', 'LastName': 'Dyer', 'Affiliation': 'School of Media and Communication, RMIT University, Melbourne 3001, Australia; jair.garcia@rmit.edu.au (J.E.G.); adrian.dyer@rmit.edu.au (A.G.D.).'}]",Clocks & sleep,['10.3390/clockssleep2020017']
1932,33089202,Can Special Light Glasses Reduce Sleepiness and Improve Sleep of Nightshift Workers? A Placebo-Controlled Explorative Field Study.,"Nightshift workers go against the natural sleep-wake rhythm. Light can shift the circadian clock but can also induce acute alertness. This placebo-controlled exploratory field study examined the effectiveness of light glasses to improve alertness while reducing the sleep complaints of hospital nurses working nightshifts. In a crossover within-subjects design, 23 nurses participated, using treatment glasses and placebo glasses. Sleepiness and sleep parameters were measured. A linear mixed model analysis on sleepiness revealed no significant main effect of the light intervention. An interaction effect was found indicating that under the placebo condition, sleepiness was significantly higher on the first nightshift than on the last night, while under the treatment condition, sleepiness remained stable across nightshift sessions. Sleepiness during the commute home also showed a significant interaction effect, demonstrating that after the first nightshift, driver sleepiness was higher for placebo than for treatment. Subjective sleep quality showed a negative main effect of treatment vs. placebo, particularly after the first nightshift. In retrospect, both types of light glasses were self-rated as effective. The use of light glasses during the nightshift may help to reduce driver sleepiness during the commute home, which is relevant, as all participants drove home by car or (motor) bike.",2020,"Subjective sleep quality showed a negative main effect of treatment vs. placebo, particularly after the first nightshift.","['23 nurses participated, using treatment glasses and placebo glasses', 'hospital nurses working nightshifts']","['light glasses', 'placebo', 'Placebo']","['Sleepiness', 'Sleepiness and sleep parameters', 'driver sleepiness', 'Subjective sleep quality']","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1271036', 'cui_str': 'Hospital nurse'}, {'cui': 'C0043227', 'cui_str': 'Working'}]","[{'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0684312', 'cui_str': 'Vehicle driver'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}]",23.0,0.0361448,"Subjective sleep quality showed a negative main effect of treatment vs. placebo, particularly after the first nightshift.","[{'ForeName': 'Mariëlle P J', 'Initials': 'MPJ', 'LastName': 'Aarts', 'Affiliation': 'Department of the Built Environment, Eindhoven University of Technology, P.O. Box 513, 5600 MB Eindhoven, The Netherlands; K.Morsink@tue.nl (K.M.); H.S.M.Kort@tue.nl (H.S.M.K.).'}, {'ForeName': 'Steffen L', 'Initials': 'SL', 'LastName': 'Hartmeyer', 'Affiliation': 'Department of Industrial Engineering and Innovation Sciences, Eindhoven University of Technology, P.O. Box 513, 5600 MB Eindhoven, The Netherlands; S.L.Hartmeyer@student.tue.nl (S.L.H.); Y.A.W.d.Kort@tue.nl (Y.A.W.d.K.).'}, {'ForeName': 'Kars', 'Initials': 'K', 'LastName': 'Morsink', 'Affiliation': 'Department of the Built Environment, Eindhoven University of Technology, P.O. Box 513, 5600 MB Eindhoven, The Netherlands; K.Morsink@tue.nl (K.M.); H.S.M.Kort@tue.nl (H.S.M.K.).'}, {'ForeName': 'Helianthe S M', 'Initials': 'HSM', 'LastName': 'Kort', 'Affiliation': 'Department of the Built Environment, Eindhoven University of Technology, P.O. Box 513, 5600 MB Eindhoven, The Netherlands; K.Morsink@tue.nl (K.M.); H.S.M.Kort@tue.nl (H.S.M.K.).'}, {'ForeName': 'Yvonne A W', 'Initials': 'YAW', 'LastName': 'de Kort', 'Affiliation': 'Department of Industrial Engineering and Innovation Sciences, Eindhoven University of Technology, P.O. Box 513, 5600 MB Eindhoven, The Netherlands; S.L.Hartmeyer@student.tue.nl (S.L.H.); Y.A.W.d.Kort@tue.nl (Y.A.W.d.K.).'}]",Clocks & sleep,['10.3390/clockssleep2020018']
1933,33089220,"Protocol for an economic evaluation and budget impact assessment of a randomised, stepped-wedge controlled trial for practice change support to increase routine provision of antenatal care for maternal alcohol consumption.","Background


Antenatal clinical practice guidelines recommend routine assessment of women's alcohol consumption during pregnancy. The delivery of advice and referral when necessary are also recommended. However, evidence suggests there are barriers to the uptake of best-care guidelines. Effective, cost-effective and affordable implementation strategies are needed to ensure the intended benefits of guidelines are realised through addressing identified barriers. This paper describes the protocol for evaluating the efficiency and affordability of a practice change intervention compared to the usual practice in an implementation trial.
Methods


The effectiveness of the intervention will be evaluated in a stepped-wedge randomised controlled implementation trial, conducted in an Australian setting. An economic evaluation will be conducted alongside the trial to assess intervention efficiency. A budget impact assessment will be conducted to assess affordability. The prospective trial-based economic evaluation will identify, measure and value key resource and outcome impacts arising from the multi-strategy practice change intervention compared with usual practice. The evaluation will comprise (i) cost-consequence analyses, where a scorecard approach will be used to show the costs and benefits given the multiple primary outcomes included in the trial, and (ii) cost-effectiveness analyses, where the primary outcome will be incremental cost per percent increase in participants reporting receipt of antenatal care for maternal alcohol consumption consistent with the guideline recommendations. Intervention affordability will be evaluated using budget impact assessment and will estimate the financial implications of adoption and diffusion of this implementation strategy from the perspective of relevant fundholders. Results will be extrapolated to estimate the cost and cost-effectiveness of rolling out the model of care.
Discussion


Uptake of clinical guidelines requires practice change support. It is hypothesized that the implementation strategy, if found to be effective, will also be cost-effective, affordable and scalable. This protocol describes the economic evaluation that will address these hypotheses.
Trial registration


Australian and New Zealand Clinical Trials Registry, ACTRN12617000882325. Registered on 16 June 2017.",2020,"The effectiveness of the intervention will be evaluated in a stepped-wedge randomised controlled implementation trial, conducted in an Australian setting.","[""women's alcohol consumption during pregnancy"", 'antenatal care for maternal alcohol consumption']",[],"['Effective, cost-effective', 'cost and cost-effectiveness']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1959897', 'cui_str': 'Alcohol consumption during pregnancy'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}]",[],"[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.0866675,"The effectiveness of the intervention will be evaluated in a stepped-wedge randomised controlled implementation trial, conducted in an Australian setting.","[{'ForeName': 'Penny', 'Initials': 'P', 'LastName': 'Reeves', 'Affiliation': 'Hunter Medical Research Institute (HMRI), Lot 1, Kookaburra Circuit, New Lambton Heights, New South Wales 2305 Australia.'}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Szewczyk', 'Affiliation': 'Hunter Medical Research Institute (HMRI), Lot 1, Kookaburra Circuit, New Lambton Heights, New South Wales 2305 Australia.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Kingsland', 'Affiliation': 'Hunter Medical Research Institute (HMRI), Lot 1, Kookaburra Circuit, New Lambton Heights, New South Wales 2305 Australia.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Doherty', 'Affiliation': 'Hunter Medical Research Institute (HMRI), Lot 1, Kookaburra Circuit, New Lambton Heights, New South Wales 2305 Australia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Elliott', 'Affiliation': 'Faculty of Medicine and Health and Discipline of Child and Adolescent Health, University of Sydney, Sydney, New South Wales Australia.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Dunlop', 'Affiliation': 'Drug and Alcohol Clinical Services, Hunter New England Local Health District, Newcastle, New South Wales Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Searles', 'Affiliation': 'Hunter Medical Research Institute (HMRI), Lot 1, Kookaburra Circuit, New Lambton Heights, New South Wales 2305 Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Wiggers', 'Affiliation': 'Hunter Medical Research Institute (HMRI), Lot 1, Kookaburra Circuit, New Lambton Heights, New South Wales 2305 Australia.'}]",Implementation science communications,['10.1186/s43058-020-00079-5']
1934,33089247,Effect of Three Wavelengths of Diode Laser on the Efficacy of Bleaching of Stained Teeth.,"Objectives


Light irradiation and heat have been used to accelerate the process of tooth bleaching. This study aimed to assess the efficacy of conventional bleaching compared to laser-bleaching using three different wavelengths of diode lasers.
Materials and Methods


In this in-vitro experimental study, 40 extracted human central incisors were immersed in a coloring solution made of tea, coffee, and cola for 21 days. The L*, a*, and b* color parameters were measured before and after the immersion using spectrophotometry. The teeth were then randomly divided into four groups (n=10) as follows: group 1: 810-nm diode laser + Biolase Laser White 20, group 2: 940-nm diode laser + Biolase Laser White 20, group 3: 980-nm diode laser + Biolase Laser White 20, and group 4: conventional bleaching with Opalescence Boost without laser irradiation. One-way analysis of variance (ANOVA) was used to assess the effect of laser type and bleaching technique on color parameters.
Results


The 940-nm (ΔE=28.5896) and 810-nm laser groups (ΔE=21.2382) showed the highest and the lowest bleaching efficacy, respectively; however, the groups were not significantly different in terms of bleaching efficacy (P>0.05).
Conclusion


Laser-bleaching with 810-, 940- and 980-nm wavelengths of diode laser has an efficacy similar to that of conventional bleaching but in a shorter period. No difference was noted between different laser wavelengths in terms of bleaching efficacy.",2019,No difference was noted between different laser wavelengths in terms of bleaching efficacy.,['40 extracted human central incisors'],"['810-nm diode laser + Biolase Laser White 20, group 2: 940-nm diode laser + Biolase Laser White 20, group 3: 980-nm diode laser + Biolase Laser White 20, and group 4: conventional bleaching with Opalescence Boost without laser irradiation', 'Laser-bleaching with 810-, 940- and 980-nm wavelengths of diode laser', 'laser type and bleaching technique', 'Diode Laser', 'Bleaching of Stained Teeth', 'laser-bleaching', 'conventional bleaching']",['bleaching efficacy'],"[{'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0021156', 'cui_str': 'Structure of incisor tooth'}]","[{'cui': 'C0392254', 'cui_str': 'Semiconductor laser device'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C4517905', 'cui_str': '940'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0441876', 'cui_str': 'Group 4'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0296695', 'cui_str': 'tooth-bleaching agent, Opalescence'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0303749', 'cui_str': 'Bleach'}, {'cui': 'C0449819', 'cui_str': 'Wavelength'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0040434', 'cui_str': 'Staining of tooth'}]","[{'cui': 'C0303749', 'cui_str': 'Bleach'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",40.0,0.0245451,No difference was noted between different laser wavelengths in terms of bleaching efficacy.,"[{'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Saeedi', 'Affiliation': 'Department of Operative Dentistry, School of Dentistry, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Ladan Ranjbar', 'Initials': 'LR', 'LastName': 'Omrani', 'Affiliation': 'Laser Research Center of Dentistry, Dentistry Research Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mahdi', 'Initials': 'M', 'LastName': 'Abbasi', 'Affiliation': 'Laser Research Center of Dentistry, Dentistry Research Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Nasim', 'Initials': 'N', 'LastName': 'Chiniforush', 'Affiliation': 'Laser Research Center of Dentistry, Dentistry Research Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mojgan', 'Initials': 'M', 'LastName': 'Kargar', 'Affiliation': 'Department of Pediatric Dentistry, School of Dentistry, Tehran University of Medical Sciences, Tehran, Iran.'}]",Frontiers in dentistry,['10.18502/fid.v16i6.3445']
1935,33089287,[Clinical study of digital clear aligner treatment of 33 adult periodontal disease patients with malocclusion].,"PURPOSE


The purpose of this study was to investigate the periodontal status in adult periodontal disease patients with malocclusion treated with digital clear aligners.
METHODS


Thirty-three patients with periodontal disease who needed orthodontic treatment were selected. The patients were randomly divided into 2 groups, digital clear aligners group (experimental group, 16 patients) and fixed appliances group (control group, 17 patients). Bleeding index (BI), probing depth(PD), plaque index(PLI) and gingival index(GI) were recorded at baseline and 1, 3, 6 and 9 months during orthodontic treatment. SPSS 17.0 software package was used to analyze and compare the data of periodontal status between two groups.
RESULTS


1, 3, 6, and 9 months after orthodontic treatment, clinical parameters of the control group were significantly higher than baseline(P<0.05). The same measurements of the experimental group showed no significant differences at 1, 3, 6, and 9 months of treatment (P>0.05). After 1, 3, 6, and 9 months of treatment, the clinical parameters of BI, PLI and GI in the experimental group were significantly lower than the control group(P<0.05); PD in the experimental group was smaller than the control group, but there was no significant difference(P>0.05).
CONCLUSIONS


Compared with conventional fixed appliance, clear aligner of digitalization can more effectively maintain periodontal heath in adult periodontal disease patients with malocclusion.",2020,"The same measurements of the experimental group showed no significant differences at 1, 3, 6, and 9 months of treatment (P>0.05).","['adult periodontal disease patients with malocclusion', 'Thirty-three patients with periodontal disease who needed orthodontic treatment were selected', 'adult periodontal disease patients with malocclusion treated with digital clear aligners', '33 adult periodontal disease patients with malocclusion']","['digital clear aligners group (experimental group, 16 patients) and fixed appliances group (control group', 'digital clear aligner treatment', 'conventional fixed appliance, clear aligner of digitalization']","['Bleeding index (BI), probing depth(PD), plaque index(PLI) and gingival index(GI', 'clinical parameters of BI, PLI and GI']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0031090', 'cui_str': 'Periodontal disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024636', 'cui_str': 'Malocclusion'}, {'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0204193', 'cui_str': 'Orthodontic procedure'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0521097', 'cui_str': 'Cleared by'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0521097', 'cui_str': 'Cleared by'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441421', 'cui_str': 'Fixed orthodontic appliance'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C2919279', 'cui_str': 'Administration of digitalis'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}]",33.0,0.0120566,"The same measurements of the experimental group showed no significant differences at 1, 3, 6, and 9 months of treatment (P>0.05).","[{'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Han', 'Affiliation': 'Department of Orthodontics, Hefei Stomatological Hospital. Hefei 230001, Anhui Province, China. E-mail:ellenhan623@126.com.'}, {'ForeName': 'Jun-Wei', 'Initials': 'JW', 'LastName': 'Zhao', 'Affiliation': ''}, {'ForeName': 'Hai-Qin', 'Initials': 'HQ', 'LastName': 'DA', 'Affiliation': ''}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Xia', 'Affiliation': ''}, {'ForeName': 'Bi-Xuan', 'Initials': 'BX', 'LastName': 'Qian', 'Affiliation': ''}]",Shanghai kou qiang yi xue = Shanghai journal of stomatology,[]
1936,33089290,[Therapeutic effect of chlorhexidine combined with mechanical debridement on peri-implantitis and its influence on patients' SF-36 score].,"PURPOSE


To study the effect of chlorhexidine combined with mechanical debridement on peri-implant inflammation and the influence on SF-36 score of patients.
METHODS


One hundred patients with peri-implantitis admitted to Zhejiang Provincial People's Hospital from January 2015 to January 2019 were selected and randomly divided into control group and combined group with 50 cases in each group according to random number table method.Patients in both groups were treated with mechanical debridement, and patients in the combined group were gargled with chlorhexidine gargle apart from mechanical debridement. Plaque biofilm average activity and modified plaque index (mPLI), bleeding on probing (BOP), modified sulcus bleeding index (mSBI), probing the depth (PPD), clinical attachment level(AL) were measured before and after treatment. Sf-36 scale and VAS visual pain score were used to evaluate the quality of life and pain degree of patients, and the therapeutic effect and incidence of complications were assessed. The data were analyzed with SPSS 20.0 software package.
RESULTS


There was no significant difference in average activity, mPLI, mSBI, AL, PPD, BOP, VAS and SF-36 scores between the two groups before treatment(P>0.05); after treatment, the average activity, mPLI, mSBI, AL, PPD, BOP and VAS scores of plaque biofilm in the combined group were significantly lower than those of the control group, and the total effective rate of SF-36 score was significantly higher than that of the control group. The total effective rate of the combined group was significantly higher than that of the control group(P<0.05). The incidence of complications in the combined group was significantly lower than that in the control group(P<0.05).
CONCLUSIONS


Chlorhexidine combined with mechanical debridement is an effective treatment of peri-implantitis, which can effectively inhibit plaque biofilm activity and plaque formation, alleviate pain and improve the quality of life of patients.",2020,"Plaque biofilm average activity and modified plaque index (mPLI), bleeding on probing (BOP), modified sulcus bleeding index (mSBI), probing the depth (PPD), clinical attachment level(AL) were measured before and after treatment.","['patients', ""One hundred patients with peri-implantitis admitted to Zhejiang Provincial People's Hospital from January 2015 to January 2019"", ""patients' SF-36 score""]","['Chlorhexidine combined with mechanical debridement', 'chlorhexidine gargle apart from mechanical debridement', 'chlorhexidine combined with mechanical debridement', 'mechanical debridement']","['Sf-36 scale and VAS visual pain score', 'Plaque biofilm average activity and modified plaque index (mPLI), bleeding on probing (BOP), modified sulcus bleeding index (mSBI), probing the depth (PPD), clinical attachment level(AL', 'total effective rate of SF-36 score', 'peri-implantitis', 'total effective rate', 'quality of life and pain degree', 'incidence of complications', 'average activity, mPLI, mSBI, AL, PPD, BOP, VAS and SF-36 scores', 'average activity, mPLI, mSBI, AL, PPD, BOP and VAS scores of plaque biofilm', 'peri-implant inflammation', 'SF-36 score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C2936258', 'cui_str': 'Dental peri-implantitis'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C0026647', 'cui_str': 'Oromucosal solution for gargle'}]","[{'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0081786', 'cui_str': 'Biofilm'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2936258', 'cui_str': 'Dental peri-implantitis'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0034131', 'cui_str': 'Purified Protein Derivative of Tuberculin'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",100.0,0.0217289,"Plaque biofilm average activity and modified plaque index (mPLI), bleeding on probing (BOP), modified sulcus bleeding index (mSBI), probing the depth (PPD), clinical attachment level(AL) were measured before and after treatment.","[{'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Cheng', 'Affiliation': ""Department of Stomatology, Zhejiang Provincial People's Hospital. Hangzhou 310014, Zhejiang Province, China. E-mail:chenggang201901@163.com.""}, {'ForeName': 'Liu-Hong', 'Initials': 'LH', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Xin-Tian', 'Initials': 'XT', 'LastName': 'Lou', 'Affiliation': ''}, {'ForeName': 'Yi-Lin', 'Initials': 'YL', 'LastName': 'Wang', 'Affiliation': ''}]",Shanghai kou qiang yi xue = Shanghai journal of stomatology,[]
1937,33089293,[Clinical study of Bio-Oss powder and Bio-Oss collagen for site preservation during implantology].,"PURPOSE


To investigate the effect of Bio-Oss bone powder combined with Heal-All Oral repair membrane and Bio-Oss collagen on site preservation during implantology.
METHODS


A total of 26 cases were randomly divided into 2 groups. In Bio-Oss bone powder group (13 cases), the sockets were filled with Bio-Oss bone powder, covering with Heal-All Oral repair membrane on the surface. In Bio-Oss collagen group (13 cases), the sockets were filled with Bio-Oss collagen only. The changes in alveolar bone density，height，width and new bone contour were evaluated with cone-beam CT(CBCT) after site preservation. The data were analyzed with SPSS 17.0 software package.
RESULTS


There was no significant difference in new bone contour between 2 groups(P>0.05). The changes in height, width and grey level of alveolar bone between the two groups were significantly different after 3 months of follow-up(P<0.01), but the curative effect was similar(P>0.05).
CONCLUSIONS


There is no significant difference in the efficacy of site preservation between the two materials. However, the site preservation technique using collagen is simple, less invasive and less costly.",2020,"The changes in height, width and grey level of alveolar bone between the two groups were significantly different after 3 months of follow-up(P<0.01), but the curative effect was similar(P>0.05).
",['A total of 26 cases'],"['Bio-Oss powder and Bio-Oss collagen', 'Bio-Oss bone powder combined with Heal-All Oral repair membrane and Bio-Oss collagen']","['efficacy of site preservation', 'new bone contour', 'alveolar bone density，height，width and new bone contour', 'height, width and grey level of alveolar bone']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0868928', 'cui_str': 'Case'}]","[{'cui': 'C0174021', 'cui_str': 'Bio-Oss'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C2945843', 'cui_str': 'Site of'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C1269776', 'cui_str': 'Gray color'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",26.0,0.0196675,"The changes in height, width and grey level of alveolar bone between the two groups were significantly different after 3 months of follow-up(P<0.01), but the curative effect was similar(P>0.05).
","[{'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Xu', 'Affiliation': ""Department of Stomatology, The Third Affiliated Hospital of Soochow University, The First People's Hospital of Changzhou City. Changzhou 213003, China. E-mail:xudan1984318@163.com.""}, {'ForeName': 'Chun', 'Initials': 'C', 'LastName': 'Yao', 'Affiliation': ''}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Gu', 'Affiliation': ''}]",Shanghai kou qiang yi xue = Shanghai journal of stomatology,[]
1938,33089296,[Changes of bone mass after implantation of Bio-Oss bone powder combined with platelet-rich fibrin for guided bone regeneration in alveolar bone defects].,"PURPOSE


To investigate the effect of Bio-Oss bone powder combined with platelet-rich fibrin on bone mass after implantation-guided bone regeneration in alveolar bone defects.
METHODS


One hundred and six patients with single anterior tooth loss and labial alveolar bone defect were selected for implant implantation and guided bone regeneration at the same time. Patients in the experimental group (n=53) were treated with Bio-Oss bone powder combined with platelet-rich fibrin and biofilm to guide bone regeneration, while patients in the control group(n=53) were treated with Bio-Oss bone powder combined with biofilm to guide bone regeneration. The success rate of implantation, complication rate, the thickness of labial bone wall and the regeneration of bone defect were observed. Statistical analysis was performed on the data using SPSS 25.0 software package.
RESULTS


There was no significant difference in the success rate of implants between the two groups(96.23% vs 88.68%, P>0.05). The thickness of the labial bone wall of the experimental group 12 months after implantation was significantly higher than that of the control group[(2.72±0.43) mm vs(2.51±0.36) mm], and the thickness of the labial wall of the implant at different sites was significantly greater than that of the control group(P<0.05). Bleeding index [(0.32±0.02) vs (0.42±0.03)], depth of probing [(3.31±0.69) mm vs (4.32±0.95) mm], loss of attachment [(3.06±0.52) mm vs (5.24±1.35) mm] was significantly smaller in the experimental group than in the control group (P<0.05); bone graft height [(2.61±0.52) mm vs (2.31±0.35) mm], osteogenesis height [(2.59±0.32) mm vs (2.01±0.16) mm] was significantly greater in the experimental group than in the control group(P<0.05). There was no significant difference in the incidence of complications between the two groups(1.89% vs 5.66%, P>0.05).
CONCLUSIONS


Bio-Oss bone powder combined with platelet-rich fibrin can reduce bone loss and promote bone defect regeneration after guided bone regeneration.",2020,"There was no significant difference in the incidence of complications between the two groups(1.89% vs 5.66%, P>0.05).
","['Patients in the experimental group (n=53', 'alveolar bone defects', 'One hundred and six patients with single anterior tooth loss and labial alveolar bone defect']","['Bio-Oss bone powder combined with platelet-rich fibrin', 'Bio-Oss bone powder combined with biofilm to guide bone regeneration', 'implant implantation and guided bone regeneration', 'Bio-Oss bone powder combined with platelet-rich fibrin and biofilm to guide bone regeneration']","['bone loss', 'depth of probing ', 'loss of attachment ', 'osteogenesis height', 'thickness of the labial bone wall', 'Bleeding index', 'incidence of complications', 'bone graft height', 'success rate of implantation, complication rate, the thickness of labial bone wall and the regeneration of bone defect', 'success rate of implants']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0080233', 'cui_str': 'Tooth loss'}, {'cui': 'C0023759', 'cui_str': 'Lip structure'}]","[{'cui': 'C0174021', 'cui_str': 'Bio-Oss'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C4505052', 'cui_str': 'Leukocyte- and Platelet-Rich Fibrin'}, {'cui': 'C0081786', 'cui_str': 'Biofilm'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0005972', 'cui_str': 'Bone Regeneration'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0029433', 'cui_str': 'Bone formation'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0023759', 'cui_str': 'Lip structure'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0205380', 'cui_str': 'Walled'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0005976', 'cui_str': 'Bone graft'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0034963', 'cui_str': 'Regeneration'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0021102', 'cui_str': 'Implant'}]",106.0,0.0587273,"There was no significant difference in the incidence of complications between the two groups(1.89% vs 5.66%, P>0.05).
","[{'ForeName': 'Shao-Shao', 'Initials': 'SS', 'LastName': 'Huang', 'Affiliation': ""Department of Stomatology, Baise People's Hospital. Baise 533000, Guangxi Zhuang Autonomous Region, China. E-mail:57296604@qq.com.""}, {'ForeName': 'Rong-Cai', 'Initials': 'RC', 'LastName': 'Tan', 'Affiliation': ''}, {'ForeName': 'Xiao-Lan', 'Initials': 'XL', 'LastName': 'Kuang', 'Affiliation': ''}]",Shanghai kou qiang yi xue = Shanghai journal of stomatology,[]
1939,31759877,Teres major transfer to restore external rotation of shoulder in Erb palsy patients.,"BACKGROUND


The lack of external rotation and shoulder abduction as sequelae of obstetric brachial plexus palsy requires a release of the subscapularis muscle associated with tendon transfer of the internal rotator of the shoulder. The aim of this study was to present the results of a teres major transfer to the infraspinatus tendon.
METHODS


This study included 20 patients (9 boys and 11 girls) with a mean age of 3 years 8 months (range, 1.5-14 years). The average follow-up time was 42 months (range, 12-48 months) to determine whether external rotation weakness and internal rotation contracture sequelae were managed by anterior release of the subscapularis and teres major tendon transfer to the infraspinatus tendon.
RESULTS


We found marked improvement in shoulder abduction from 67° before surgery to 158° after surgery. We also found marked improvements in active external rotation from 8° before surgery to 85° after surgery and in passive external rotation from 0° preoperatively to 72° postoperatively. Two cases showed a loss of the last degrees of internal rotation, but this improved after physiotherapy.
CONCLUSIONS


Anterior release of the subscapularis tendon with a teres major transfer to the infraspinatus tendon significantly improves shoulder function in Erb palsy patients with internal rotation contracture.",2020,We also found marked improvements in active external rotation from 8° before surgery to 85° after surgery and in passive external rotation from 0° preoperatively to 72° postoperatively.,"['Erb\xa0palsy patients', 'obstetric brachial plexus palsy', '20 patients (9 boys and 11 girls) with a mean age of 3 years 8 months (range, 1.5-14 years', 'Erb palsy patients with internal rotation contracture']",['external rotation and shoulder abduction'],"['shoulder function', 'active external rotation', 'external rotation weakness and internal rotation contracture sequelae', 'loss of the last degrees of internal rotation', 'shoulder abduction']","[{'cui': 'C0270897', 'cui_str': 'Erb-Duchenne paralysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0006090', 'cui_str': 'Brachial plexus structure'}, {'cui': 'C0522224', 'cui_str': 'Paralysis'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0231459', 'cui_str': 'Internal rotation'}, {'cui': 'C0009917', 'cui_str': 'Contracture'}]","[{'cui': 'C0231462', 'cui_str': 'External rotation'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0086505', 'cui_str': 'Kidnapping'}]","[{'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0231462', 'cui_str': 'External rotation'}, {'cui': 'C3714552', 'cui_str': 'Debility'}, {'cui': 'C0231459', 'cui_str': 'Internal rotation'}, {'cui': 'C0009917', 'cui_str': 'Contracture'}, {'cui': 'C0243088', 'cui_str': 'sequels'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0086505', 'cui_str': 'Kidnapping'}]",20.0,0.0195183,We also found marked improvements in active external rotation from 8° before surgery to 85° after surgery and in passive external rotation from 0° preoperatively to 72° postoperatively.,"[{'ForeName': 'Ashraf M', 'Initials': 'AM', 'LastName': 'Abdelaziz', 'Affiliation': 'Alzhraa University Hospital, Faculty of Medicine for Girls, Al-Azhar University, Cairo, Egypt. Electronic address: ashrafabdelaziz2010@yahoo.com.'}, {'ForeName': 'Wael', 'Initials': 'W', 'LastName': 'Aldahshan', 'Affiliation': 'Alzhraa University Hospital, Faculty of Medicine for Girls, Al-Azhar University, Cairo, Egypt.'}, {'ForeName': 'Faisal Ahmed', 'Initials': 'FA', 'LastName': 'Hashem Elsherief', 'Affiliation': 'Alzhraa University Hospital, Faculty of Medicine for Girls, Al-Azhar University, Cairo, Egypt.'}, {'ForeName': 'Mahmoud Ali', 'Initials': 'MA', 'LastName': 'Ismail', 'Affiliation': 'Alzhraa University Hospital, Faculty of Medicine for Girls, Al-Azhar University, Cairo, Egypt.'}, {'ForeName': 'Amro A', 'Initials': 'AA', 'LastName': 'Fouaad', 'Affiliation': 'Alzhraa University Hospital, Faculty of Medicine for Girls, Al-Azhar University, Cairo, Egypt.'}, {'ForeName': 'Wael Sh', 'Initials': 'WS', 'LastName': 'Mahmoud', 'Affiliation': 'Alzhraa University Hospital, Faculty of Medicine for Girls, Al-Azhar University, Cairo, Egypt.'}, {'ForeName': 'Tharwat', 'Initials': 'T', 'LastName': 'Al Akeed', 'Affiliation': 'Alzhraa University Hospital, Faculty of Medicine for Girls, Al-Azhar University, Cairo, Egypt.'}, {'ForeName': 'Mahmoud Mabrouk', 'Initials': 'MM', 'LastName': 'Said', 'Affiliation': 'Alzhraa University Hospital, Faculty of Medicine for Girls, Al-Azhar University, Cairo, Egypt.'}]",Journal of shoulder and elbow surgery,['10.1016/j.jse.2019.09.017']
1940,32359044,Group Versus Standard Behavioral Couples' Therapy for Alcohol Use Disorder Patients: Cost-Effectiveness.,"OBJECTIVE


The purpose of this study was to evaluate the costs and cost-effectiveness of two treatments for 101 alcohol use disorder patients and their intimate partners--group behavioral couples' therapy plus individual-based treatment (G-BCT), or standard behavioral couples' therapy plus individual-based treatment (S-BCT).
METHOD


We estimated the per-patient cost of each intervention using a microcosting approach that allowed us to estimate costs of specific components in each intervention as well as the overall total costs. Using simple means analysis and multiple regression models, we estimated the incremental effectiveness of G-BCT relative to S-BCT. Immediately after treatment and 12 months after treatment, we computed incremental cost-effectiveness ratios (ICER) and cost-effectiveness acceptability curves for percentage days abstinent, adverse consequences of alcohol and drugs, and overall relationship functioning.
RESULTS


The average per-patient cost of delivering G-BCT was $674, significantly less than the cost of S-BCT ($831). However, 12 months after treatment, S-BCT participants performed better on all outcomes compared with those in G-BCT, and the calculated ICER moving from G-BCT to S-BCT ranged from $10 to $12 across these outcomes. The current findings indicated that, except at very low willingness-to-pay values, S-BCT is a cost-effective option relative to G-BCT when considering 12-month posttreatment outcomes.
CONCLUSIONS


As expected, G-BCT was delivered at a lower cost per patient than S-BCT; however, S-BCT performed better over time on the clinical outcomes studied. These economic findings indicate that alcohol use disorder treatment providers should seriously consider S-BCT over G-BCT when deciding what format to use in behavioral couples' therapy.",2020,"However, 12 months after treatment, S-BCT participants performed better on all outcomes compared with those in G-BCT, and the calculated ICER moving from G-BCT to S-BCT ranged from $10 to $12 across these outcomes.",['101 alcohol use disorder patients and their intimate partners--group behavioral couples'],"[""Standard Behavioral Couples' Therapy"", ""therapy plus individual-based treatment (G-BCT), or standard behavioral couples' therapy plus individual-based treatment (S-BCT""]","['average per-patient cost of delivering G-BCT', 'costs and cost-effectiveness', 'incremental cost-effectiveness ratios (ICER) and cost-effectiveness acceptability curves for percentage days abstinent, adverse consequences of alcohol and drugs, and overall relationship functioning']","[{'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0010222', 'cui_str': 'Couples'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0917927', 'cui_str': 'Breast conserving surgery'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0917927', 'cui_str': 'Breast conserving surgery'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0457801', 'cui_str': 'Non - drinker'}, {'cui': 'C0686907', 'cui_str': 'Consequence of'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",,0.0223731,"However, 12 months after treatment, S-BCT participants performed better on all outcomes compared with those in G-BCT, and the calculated ICER moving from G-BCT to S-BCT ranged from $10 to $12 across these outcomes.","[{'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Dunlap', 'Affiliation': 'RTI International, Research Triangle Park, North Carolina.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': ""O'Farrell"", 'Affiliation': 'Veterans Affairs Boston Healthcare System, Brockton, Massachusetts.'}, {'ForeName': 'Jeremiah A', 'Initials': 'JA', 'LastName': 'Schumm', 'Affiliation': 'School of Professional Psychology, Wright State University, Ellis Human Development Institute, Dayton, Ohio.'}, {'ForeName': 'Stephen S', 'Initials': 'SS', 'LastName': 'Orme', 'Affiliation': 'RTI International, Washington, DC.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Murphy', 'Affiliation': 'Veterans Affairs Boston Healthcare System, Brockton, Massachusetts.'}, {'ForeName': 'Patrice M', 'Initials': 'PM', 'LastName': 'Murchowski', 'Affiliation': 'AdCare Hospital of Worcester, Worcester, Massachusetts.'}]",Journal of studies on alcohol and drugs,[]
1941,33081758,Reducing neonatal morbidity by discontinuing oxytocin during the active phase of first stage of labor: a multicenter randomized controlled trial STOPOXY.,"BACKGROUND


Oxytocin is effective in reducing labor duration, but can be associated with fetal and maternal complications such as neonatal acidosis and post-partum hemorrhage. When comparing discontinuing oxytocin in the active phase with continuing oxytocin infusion, previous studies were underpowered to show a reduction in neonatal morbidity. Thus, we aim at evaluating the impact of discontinuing oxytocin during the active phase of the first stage of labor on the neonatal morbidity rate.
METHODS


STOPOXY is a multicenter, randomized, open-label, controlled trial conducted in 20 maternity units in France. The first participant was recruited January 17th 2020. The trial includes women with a live term (≥37 weeks) singleton, in cephalic presentation, receiving oxytocin before 4 cm, after an induced or spontaneous labor. Women aged < 18 years, with a lack of social security coverage, a scarred uterus, a multiple pregnancy, a fetal congenital malformation, a growth retardation <3rd percentile or an abnormal fetal heart rate at randomization are excluded. Women are randomized before 6 cm when oxytocin is either continued or discontinued. Randomization is stratified by center and parity. The primary outcome, neonatal morbidity is assessed using a composite variable defined by an umbilical arterial pH at birth < 7.10 and/or a base excess > 10 mmol/L and/or umbilical arterial lactates> 7 mmol/L and/or a 5 min Apgar score < 7 and/or admission in neonatal intensive care unit. The primary outcome will be compared between the two groups using a chi-square test with a p-value of 0.05. Secondary outcomes include neonatal complications, duration of active phase, mode of delivery, fetal and maternal complications during labor and delivery, including cesarean delivery rate and postpartum hemorrhage, and birth experience. We aim at including 2475 women based on a reduction in neonatal morbidity from 8% in the control group to 5% in the experimental group, with a power of 80% and an alpha risk of 5%.
DISCUSSION


Discontinuing oxytocin during the active phase of labor could improve both child health, by reducing moderate to severe neonatal morbidity, and maternal health by reducing cesarean delivery and postpartum hemorrhage rates.
TRIAL REGISTRATION


Clinical trials NCT03991091 , registered June 19th, 2019.",2020,"We aim at including 2475 women based on a reduction in neonatal morbidity from 8% in the control group to 5% in the experimental group, with a power of 80% and an alpha risk of 5%.
","['2475 women', 'Women aged <\u200918\u2009years, with a lack of social security coverage, a scarred uterus, a multiple pregnancy, a fetal congenital malformation, a growth retardation <3rd percentile or an abnormal fetal heart rate at randomization are excluded', '20 maternity units in France', 'women with a live term (≥37\u2009weeks) singleton, in cephalic presentation, receiving oxytocin before 4\u2009cm, after an induced or spontaneous labor']","['discontinuing oxytocin', 'Oxytocin', 'oxytocin']","['labor duration', 'neonatal morbidity', 'neonatal morbidity rate', 'umbilical arterial pH at birth <\u20097.10 and/or a base excess >\u200910\u2009mmol/L and/or umbilical arterial lactates>\u20097\u2009mmol/L and/or a 5\u2009min Apgar score', 'neonatal complications, duration of active phase, mode of delivery, fetal and maternal complications during labor and delivery, including cesarean delivery rate and postpartum hemorrhage, and birth experience']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332268', 'cui_str': 'Lacking'}, {'cui': 'C0037435', 'cui_str': 'Social Insurance'}, {'cui': 'C0426015', 'cui_str': 'Scarring of uterus'}, {'cui': 'C0032989', 'cui_str': 'Multiple pregnancy'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0151686', 'cui_str': 'Growth retardation'}, {'cui': 'C0205437', 'cui_str': 'Third'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0730018', 'cui_str': 'Abnormal fetal heart rate'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205096', 'cui_str': 'Cephalic'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0474461', 'cui_str': 'Spontaneous onset of labor'}]","[{'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}]","[{'cui': 'C0566679', 'cui_str': 'Duration of labor'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0041638', 'cui_str': 'Umbilical structure'}, {'cui': 'C0428199', 'cui_str': 'pH measurement, arterial'}, {'cui': 'C1744681', 'cui_str': 'Congenital'}, {'cui': 'C1143779', 'cui_str': '2-amino-7-deazaadenine'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0003533', 'cui_str': 'Finding of Apgar score'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0032797', 'cui_str': 'Postpartum hemorrhage'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]",2475.0,0.268088,"We aim at including 2475 women based on a reduction in neonatal morbidity from 8% in the control group to 5% in the experimental group, with a power of 80% and an alpha risk of 5%.
","[{'ForeName': 'Aude', 'Initials': 'A', 'LastName': 'Girault', 'Affiliation': 'Université de Paris, INSERM UMR 1153, Equipe EPOPé, 123 boulevard Port Royal, 75014, Paris, France. aude.girault@aphp.fr.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Goffinet', 'Affiliation': 'Université de Paris, INSERM UMR 1153, Equipe EPOPé, 123 boulevard Port Royal, 75014, Paris, France.'}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Le Ray', 'Affiliation': 'Université de Paris, INSERM UMR 1153, Equipe EPOPé, 123 boulevard Port Royal, 75014, Paris, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMC pregnancy and childbirth,['10.1186/s12884-020-03331-x']
1942,33081762,Clinical efficacy of enhanced recovery after surgery in percutaneous nephrolithotripsy: a randomized controlled trial.,"BACKGROUND


To evaluate the feasibility, safety, applied value and efficacy of enhanced recovery after surgery (ERAS) for PCNL for the treatment of renal calculi. Although the ERAS is applied for many urological diseases, its application in percutaneous nephrolithotripsy (PCNL) is still limited.
METHODS


This was a prospective study of patients admitted to hospital January and December 2018 and who were only diagnosed with renal calculi and excepted for serious or uncontrollable basic diseases and patients with multiple operation history and medication history. Patients were randomized 1:1 to the ERAS and traditional operation groups starting on the day before operation and end on the day of discharge. Each group was 118 cases. The stone clearance rate, visual analogue scale (VAS) pain score, the occurrence of perirenal hematoma and effusion, the incidence of extravasation of urine, the incidence of fever, bleeding and blood transfusion, and postoperative hospital stay were observed.
RESULTS


The stone clearance rates were similar between the two groups (ERAS: 93.2% (109/117) vs. traditional: 89.8% (106/118), P = 0.800). The operation time was similar in the two groups (ERAS: 54 ± 12 vs. traditional: 58 ± 11 min, P = 0.656). VAS pain score that was 0.79 ± 0.76 in the ERAS group at 4 h after surgery and was significantly lower than 2.79 ± 0.98 in the traditional group (P < 0.0001). The total complication rate was 15 cases in the ERAS group and 22 cases in the traditional group (P = 0.573). There were no difference in costs (21,348 ± 2404 vs. 21,597 ± 2293 RMB, P = 0.529).
CONCLUSIONS


ERAS perioperative management in PCNL was feasible, was without additional complications, and had well economic and social benefits. It is worth of clinical promotion and application.",2020,"The stone clearance rates were similar between the two groups (ERAS: 93.2% (109/117) vs. traditional: 89.8% (106/118), P = 0.800).","['patients admitted to hospital January and December 2018 and who were only diagnosed with renal calculi and excepted for serious or uncontrollable basic diseases and patients with multiple operation history and medication history', 'percutaneous nephrolithotripsy', 'renal calculi']",['ERAS'],"['VAS pain score', 'stone clearance rate, visual analogue scale (VAS) pain score, the occurrence of perirenal hematoma and effusion, the incidence of extravasation of urine, the incidence of fever, bleeding and blood transfusion, and postoperative hospital stay', 'operation time', 'stone clearance rates', 'total complication rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0022650', 'cui_str': 'Kidney stone'}, {'cui': 'C0332300', 'cui_str': 'Except for'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}]","[{'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0025515', 'cui_str': 'Metabolic clearance rate'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0473124', 'cui_str': 'Perinephric hematoma'}, {'cui': 'C0013687', 'cui_str': 'Effusion'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0152245', 'cui_str': 'Extravasation of urine'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",,0.0236877,"The stone clearance rates were similar between the two groups (ERAS: 93.2% (109/117) vs. traditional: 89.8% (106/118), P = 0.800).","[{'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Urology, The Fifth Affiliated Hospital of Southern Medical University, Guangzhou, 510900, China. liq73@163.com.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wan', 'Affiliation': 'Department of Urology, The First Affiliated Hospital of University of South China, Hengyang, 421001, China.'}, {'ForeName': 'Shucheng', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Department of Urology, The First Affiliated Hospital of University of South China, Hengyang, 421001, China.'}, {'ForeName': 'Mingyong', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Department of Urology, The First Affiliated Hospital of University of South China, Hengyang, 421001, China.'}, {'ForeName': 'Libo', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Urology, The First Affiliated Hospital of University of South China, Hengyang, 421001, China.'}, {'ForeName': 'Zhengwu', 'Initials': 'Z', 'LastName': 'Hou', 'Affiliation': 'Department of Urology, The First Affiliated Hospital of University of South China, Hengyang, 421001, China.'}, {'ForeName': 'Wang', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Department of Urology, The First Affiliated Hospital of University of South China, Hengyang, 421001, China.'}]",BMC urology,['10.1186/s12894-020-00728-w']
1943,33081774,The impact of multi-person virtual reality competitive learning on anatomy education: a randomized controlled study.,"BACKGROUND


Anatomy is one of the core subjects in medical education. Students spend considerable time and effort on learning the requisite anatomy knowledge. This study explored the effect of a multiple-player virtual reality (VR) gaming system on anatomy learning.
METHODS


18 participants were randomly assigned into 3 learning conditions: (1) a textbook reading control group (CG), (2) a single-player VR (SP) group; and (3) a multiple-player VR (MP) group. The participants studied anatomy for 5 days, and completed a multiple-choice test on Days 1, 5, and 12. In the VR environment, the participants used handheld controllers to move the simulated tissues. The mission of the game was to complete puzzles of a human body. The SP and MP groups filled out a motivation inventory on Day 5. The scores on the multiple-choice test, the correct assembly rates, and the motivation inventory scores were analyzed using the 2-way ANOVA or independent t-test to compare group differences.
RESULTS


There was a significant interaction effect of group and timepoint (p = 0.003) in the multiple-choice test. In the CG, the scores on Day 1, Day 5, and Day 12 were significantly different (p < 0.001). The scores on Day 5 were significantly higher than those on Day 1 (p < 0.001). Although the scores declined slightly on Day 12, they were still significantly higher than those on Day 1 (p < 0.001). The SP and MP groups had similar results (p < 0.001, p < 0.001). The differences between the groups were only significant on Day 12 (p = 0.003), not Day 5 (p = 0.06). On Day 12, the scores of the MP group were higher than those of the CG (p = 0.002). The SP group and MP group had high scores on the interest, competence, and importance subscales of the motivation inventory. Both VR groups considered the system to be fun and beneficial to their learning. However, the MP group reported higher stress levels than the SP group.
CONCLUSION


The results indicated that the proposed VR learning system had a positive impact on the anatomy learning. Although the between-player competition caused higher stress levels for the VR groups, the stress could have been a mediator of their learning outcomes.
TRIAL REGISTRATION


ETRD, ETRD-D-19-00573. Registered 20 December 2018, http://www.edah.org.tw/irb/index.htm.",2020,"The SP and MP groups had similar results (p < 0.001, p < 0.001).",['18 participants'],"['multi-person virtual reality competitive learning', 'textbook reading control group (CG), (2) a single-player VR (SP) group; and (3) a multiple-player VR (MP', 'multiple-player virtual reality (VR) gaming system']","['motivation inventory scores', 'anatomy learning', 'stress levels']",[],"[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0039712', 'cui_str': 'Textbooks'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0002808', 'cui_str': 'Anatomy'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}]",18.0,0.0181788,"The SP and MP groups had similar results (p < 0.001, p < 0.001).","[{'ForeName': 'Yi-Chun', 'Initials': 'YC', 'LastName': 'Du', 'Affiliation': 'Department of Biomedical Engineering, National Cheng Kung University, No. 1, University Rd., Tainan, 70105, Taiwan.'}, {'ForeName': 'Shih-Chen', 'Initials': 'SC', 'LastName': 'Fan', 'Affiliation': 'Department of Occupational Therapy, College of Medicine, I-Shou University, No.8, E-Da Rd., Kaohsiung, 82445, Taiwan. maggiefan15@isu.edu.tw.'}, {'ForeName': 'Li-Cheng', 'Initials': 'LC', 'LastName': 'Yang', 'Affiliation': 'Department of Electrical Engineering, Southern Taiwan University of Science and Technology, No. 1, Nantai St., Yungkang Dist., Tainan, 71005, Taiwan.'}]",BMC medical education,['10.1186/s12909-020-02155-9']
1944,33081783,Relationships between accelerometry and general compensatory movements of the upper limb after stroke.,"BACKGROUND


Standardized assessments are used in rehabilitation clinics after stroke to measure restoration versus compensatory movements of the upper limb. Accelerometry is an emerging tool that can bridge the gap between in- and out-of-clinic assessments of the upper limb, but is limited in that it currently does not capture the quality of a person's movement, an important concept to assess compensation versus restoration. The purpose of this analysis was to characterize how accelerometer variables may reflect upper limb compensatory movement patterns after stroke.
METHODS


This study was a secondary analysis of an existing data set from a Phase II, single-blind, randomized, parallel dose-response trial (NCT0114369). Sources of data utilized were: (1) a compensatory movement score derived from video analysis of the Action Research Arm Test (ARAT), and (2) calculated accelerometer variables quantifying time, magnitude and variability of upper limb movement from the same time point during study participation for both in-clinic and out-of-clinic recording periods.
RESULTS


Participants had chronic upper limb paresis of mild to moderate severity. Compensatory movement scores varied across the sample, with a mean of 73.7 ± 33.6 and range from 11.5 to 188. Moderate correlations were observed between the compensatory movement score and each accelerometer variable. Accelerometer variables measured out-of-clinic had stronger relationships with compensatory movements, compared with accelerometer variables in-clinic. Variables quantifying time, magnitude, and variability of upper limb movement out-of-clinic had relationships to the compensatory movement score.
CONCLUSIONS


Accelerometry is a tool that, while measuring movement quantity, can also reflect the use of general compensatory movement patterns of the upper limb in persons with chronic stroke. Individuals who move their limbs more in daily life with respect to time and variability tend to move with less movement compensations and more typical movement patterns. Likewise, individuals who move their paretic limbs less and their non-paretic limb more in daily life tend to move with more movement compensations at all joints in the paretic limb and less typical movement patterns.",2020,Individuals who move their limbs more in daily life with respect to time and variability tend to move with less movement compensations and more typical movement patterns.,['persons with chronic stroke'],[],['Compensatory movement scores'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}]",[],"[{'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0394398,Individuals who move their limbs more in daily life with respect to time and variability tend to move with less movement compensations and more typical movement patterns.,"[{'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Barth', 'Affiliation': 'Washington University School of Medicine, Program in Physical Therapy, St. Louis, MO, USA.'}, {'ForeName': 'Joeseph W', 'Initials': 'JW', 'LastName': 'Klaesner', 'Affiliation': 'Washington University School of Medicine, Program in Physical Therapy, St. Louis, MO, USA.'}, {'ForeName': 'Catherine E', 'Initials': 'CE', 'LastName': 'Lang', 'Affiliation': 'Washington University School of Medicine, Program in Physical Therapy, St. Louis, MO, USA. langc@wustl.edu.'}]",Journal of neuroengineering and rehabilitation,['10.1186/s12984-020-00773-4']
1945,33081817,Proactive prophylaxis with azithromycin and hydroxychloroquine in hospitalized patients with COVID-19 (ProPAC-COVID): a statistical analysis plan.,"BACKGROUND


There is an urgent need for treatments that can shorten hospitalization and lower the risk of secondary infection and death in patients with corona disease. The ProPac-COVID trial evaluates whether combination therapy with macrolide azithromycin and hydroxychloroquine via anti-inflammation/immune modulation, antiviral efficacy, and pre-emptive treatment of supra-infections can shorten hospitalization duration and reduce the risk of non-invasive ventilation, treatment in the intensive care unit, and death in patients with acute hospital admission and a positive test for 2019-nCoV and symptoms of COVID-19 disease.
METHODS


The ProPAC-COVID is a multi-center, randomized, placebo-controlled, double-blinded clinical trial. The primary outcome is number of days spent alive and out of hospital within 14 days from randomization. Randomization will be in blocks of unknown size, and the final allocation will be stratified for age, site of recruitment, and whether the patient has any chronic lung diseases. Data is analyzed using intention-to-treat (ITT) principles, and main analyses will also be subject to modified ITT analysis and per protocol analysis.
DISCUSSION


This paper describes the detailed statistical analysis plan for the evaluation of primary and secondary endpoints of the ProPAC-COVID study. Enrolment of patients to the ProPAC-COVID study is still ongoing. The purpose of this paper is to provide primary publication of study results to prevent selective reporting of outcomes, data-driven analysis, and to increase transparency.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04322396 . Registered on 26 March 2020.",2020,"BACKGROUND


There is an urgent need for treatments that can shorten hospitalization and lower the risk of secondary infection and death in patients with corona disease.","['hospitalized patients with COVID-19 (ProPAC-COVID', 'patients with corona disease', 'patients with acute hospital admission and a positive test for 2019-nCoV and symptoms of COVID-19 disease']","['azithromycin and hydroxychloroquine', 'placebo', 'macrolide azithromycin and hydroxychloroquine']",['number of days spent alive and out of hospital'],"[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0033518', 'cui_str': 'PROPAC'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0003240', 'cui_str': 'Macrolide antibiotic product'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]",,0.301302,"BACKGROUND


There is an urgent need for treatments that can shorten hospitalization and lower the risk of secondary infection and death in patients with corona disease.","[{'ForeName': 'Pradeesh', 'Initials': 'P', 'LastName': 'Sivapalan', 'Affiliation': 'Herlev and Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark. Pradeesh.s@dadlnet.dk.'}, {'ForeName': 'Charlotte Suppli', 'Initials': 'CS', 'LastName': 'Ulrik', 'Affiliation': 'Amager and Hvidovre Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Therese Sophie', 'Initials': 'TS', 'LastName': 'Lappere', 'Affiliation': 'Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Josefin Viktoria', 'Initials': 'JV', 'LastName': 'Eklöf', 'Affiliation': 'Herlev and Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Saher Burhan', 'Initials': 'SB', 'LastName': 'Shaker', 'Affiliation': 'Herlev and Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Uffe Christian Steinholtz', 'Initials': 'UCS', 'LastName': 'Bødtger', 'Affiliation': 'Næstved, Slagelse and Ringsted Hospitals, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Browatzki', 'Affiliation': 'Nordsjællands Hospital Hillerød, University of Copenhagen, Hillerød, Denmark.'}, {'ForeName': 'Christian Niels', 'Initials': 'CN', 'LastName': 'Meyer', 'Affiliation': 'Zeeland University Hospital, Roskilde, Denmark.'}, {'ForeName': 'Ulla Møller', 'Initials': 'UM', 'LastName': 'Weinreich', 'Affiliation': 'Aalborg University Hospital, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Christian B', 'Initials': 'CB', 'LastName': 'Laursen', 'Affiliation': 'Odense University Hospital, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Tor', 'Initials': 'T', 'LastName': 'Biering-Sørensen', 'Affiliation': 'Herlev and Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Filip Krag', 'Initials': 'FK', 'LastName': 'Knop', 'Affiliation': 'Herlev and Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jens D', 'Initials': 'JD', 'LastName': 'Lundgren', 'Affiliation': 'Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jens-Ulrik Stæhr', 'Initials': 'JS', 'LastName': 'Jensen', 'Affiliation': 'Herlev and Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark.'}]",Trials,['10.1186/s13063-020-04795-0']
1946,33081825,High levels of interleukin-6 in patients with rheumatoid arthritis are associated with greater improvements in health-related quality of life for sarilumab compared with adalimumab.,"BACKGROUND


Increased levels of cytokines, including interleukin-6 (IL-6), reflect inflammation and have been shown to be predictive of therapeutic responses, fatigue, pain, and depression in patients with rheumatoid arthritis (RA), but limited data exist on associations between IL-6 levels and health-related quality of life (HRQoL). This post hoc analysis of MONARCH phase III randomized controlled trial data evaluated the potential of baseline IL-6 levels to differentially predict HRQoL improvements with sarilumab, a fully human monoclonal antibody directed against both soluble and membrane-bound IL-6 receptor α (anti-IL-6Rα) versus adalimumab, a tumor necrosis factor α inhibitor, both approved for treatment of active RA.
METHODS


Baseline serum IL-6 levels in 300/369 randomized patients were categorized into low (1.6-7.1 pg/mL), medium (7.2-39.5 pg/mL), and high (39.6-692.3 pg/mL) tertiles. HRQoL was measured at baseline and week (W)24 and W52 by Short Form 36 (SF-36) physical/mental component summary (PCS/MCS) and domain scores, Functional Assessment of Chronic Illness Therapy -fatigue, and duration of morning stiffness visual analog scale (AM-stiffness VAS). Linear regression of changes from baseline in HRQoL (IL-6 tertile, treatment, region as a stratification factor, and IL-6 tertile-by-treatment interaction as fixed effects) assessed predictivity of baseline IL-6 levels, with low tertile as reference. Pairwise comparisons of improvements between treatment groups were performed by tertile; least squares mean differences and 95% CIs were calculated. Similar analyses evaluated W24 patient-level response on minimum clinically important differences (MCID).
RESULTS


At baseline, patients with high versus medium or low IL-6 levels (n = 100, respectively) reported worse (nominal p < 0.05) SF-36 MCS and role-physical, bodily pain, social functioning, role-emotional domain, and AM-stiffness VAS scores. There was a greater treatment effect with sarilumab versus adalimumab in high tertile versus low tertile groups in SF-36 PCS, physical functioning domain, and AM-stiffness VAS (nominal interaction p < 0.05). PCS improvements ≥MCID were higher in high (odds ratio [OR] 6.31 [2.37, 16.81]) versus low (OR 0.97 [0.43, 2.16]) tertiles with sarilumab versus adalimumab (nominal interaction p < 0.05). Adverse events between IL-6 tertiles were similar.
CONCLUSIONS


Patients with high baseline IL-6 levels reported better improvements in PCS, physical functioning domain, and AM-stiffness scores with sarilumab versus adalimumab and safety consistent with IL-6R blockade.
TRIAL REGISTRATION


NCT02332590 . Registered on 5 January 2015.",2020,"There was a greater treatment effect with sarilumab versus adalimumab in high tertile versus low tertile groups in SF-36 PCS, physical functioning domain, and AM-stiffness VAS (nominal interaction p < 0.05).","['patients with rheumatoid arthritis (RA', '300/369 randomized patients were categorized into low (1.6-7.1\u2009pg/mL), medium (7.2-39.5\u2009pg/mL), and high (39.6-692.3\u2009pg/mL) tertiles', 'patients with rheumatoid arthritis']","['sarilumab versus adalimumab', 'adalimumab']","['domain scores, Functional Assessment of Chronic Illness Therapy -fatigue, and duration of morning stiffness visual analog scale (AM-stiffness VAS', 'health-related quality of life', 'SF-36 MCS and role-physical, bodily pain, social functioning, role-emotional domain, and AM-stiffness VAS scores', 'HRQoL (IL-6 tertile, treatment, region as a stratification factor, and IL-6 tertile-by-treatment interaction as fixed effects) assessed predictivity of baseline IL-6 levels', 'PCS, physical functioning\xa0domain, and AM-stiffness scores', 'PCS improvements ≥MCID', 'HRQoL', 'SF-36 PCS, physical functioning domain, and AM-stiffness VAS', 'low IL-6 levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C4517508', 'cui_str': '1.6'}, {'cui': 'C0439297', 'cui_str': 'ng/L'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C4517857', 'cui_str': '7.2'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C3885145', 'cui_str': 'sarilumab'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}]","[{'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0457086', 'cui_str': 'Morning stiffness - joint'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0036221', 'cui_str': 'Mast cell sarcoma'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1882368', 'cui_str': 'Dynamic Light Scattering'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",,0.169191,"There was a greater treatment effect with sarilumab versus adalimumab in high tertile versus low tertile groups in SF-36 PCS, physical functioning domain, and AM-stiffness VAS (nominal interaction p < 0.05).","[{'ForeName': 'Vibeke', 'Initials': 'V', 'LastName': 'Strand', 'Affiliation': 'Stanford University, Palo Alto, CA, USA.'}, {'ForeName': 'Susan H', 'Initials': 'SH', 'LastName': 'Boklage', 'Affiliation': 'Formerly, Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.'}, {'ForeName': 'Toshio', 'Initials': 'T', 'LastName': 'Kimura', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Joly', 'Affiliation': 'Sanofi, 1 Avenue Pierre Brossolette, 91385, Chilly-Mazarin, France.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Boyapati', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.'}, {'ForeName': 'Jérôme', 'Initials': 'J', 'LastName': 'Msihid', 'Affiliation': 'Sanofi, 1 Avenue Pierre Brossolette, 91385, Chilly-Mazarin, France. Jerome.Msihid@sanofi.com.'}]",Arthritis research & therapy,['10.1186/s13075-020-02344-3']
1947,33081828,"Interleukin-6 Receptor Antibodies for Modulating the Systemic Inflammatory Response after Out-of-Hospital Cardiac Arrest (IMICA): study protocol for a double-blinded, placebo-controlled, single-center, randomized clinical trial.","BACKGROUND


Resuscitated out-of-hospital cardiac arrest (OHCA) patients who remain comatose at admission are at high risk of morbidity and mortality. This has been attributed to the post-cardiac arrest syndrome (PCAS) which encompasses multiple interacting components, including systemic inflammation. Elevated levels of circulating interleukin-6 (IL-6), a pro-inflammatory cytokine, is associated with worse outcomes in OHCA patients, including higher vasopressor requirements and higher mortality rates. In this study, we aim to reduce systemic inflammation after OHCA by administering a single infusion of tocilizumab, an IL-6 receptor antibody approved for use for other indications.
METHODS


Investigator-initiated, double-blinded, placebo-controlled, single-center, randomized clinical trial in comatose OHCA patients admitted to an intensive cardiac care unit. Brief inclusion criteria: OHCA of presumed cardiac cause, persistent unconsciousness, age ≥ 18 years.
INTERVENTION


80 patients will be randomized in a 1:1 ratio to a single 1-h intravenous infusion of either tocilizumab or placebo (NaCl). During the study period, patients will receive standard of care, including sedation and targeted temperature management of 36 ° for at least 24 h, vasopressors and/or inotropes as/if needed, prophylactic antibiotics, and any additional treatment at the discretion of the treating physician. Blood samples are drawn for measurements of biomarkers included in the primary and secondary endpoints during the initial 72 h. Primary endpoint: reduction in C-reactive protein (CRP). Secondary endpoints (abbreviated): cytokine levels, markers of brain, cardiac, kidney and liver damage, hemodynamic and hemostatic function, adverse events, and follow-up assessment of cerebral function and mortality.
DISCUSSION


We hypothesize that reducing the effect of circulating IL-6 by administering an IL-6 receptor antibody will mitigate the systemic inflammatory response and thereby modify the severity of PCAS, in turn leading to lessened vasopressor use, more normal hemodynamics, and better organ function. This will be assessed by primarily focusing on hemodynamics and biomarkers of organ damage during the initial 72 h. In addition, pro-inflammatory and anti-inflammatory cytokines will be measured to assess if cytokine patterns are modulated by IL-6 receptor blockage.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT03863015 ; submitted February 22, 2019, first posted March 5, 2019. EudraCT: 2018-002686-19; date study was authorized to proceed: November 7, 2018.",2020,"Elevated levels of circulating interleukin-6 (IL-6), a pro-inflammatory cytokine, is associated with worse outcomes in OHCA patients, including higher vasopressor requirements and higher mortality rates.","['80 patients', 'comatose OHCA patients admitted to an intensive cardiac care unit']","['standard of care, including sedation and targeted temperature management of 36\xa0° for at least 24\u2009h, vasopressors and/or inotropes as/if needed, prophylactic antibiotics, and any additional treatment at the discretion of the treating physician', 'placebo', 'tocilizumab', 'tocilizumab or placebo (NaCl', 'EudraCT']","['systemic inflammation', 'Elevated levels of circulating interleukin-6 (IL-6), a pro-inflammatory cytokine', 'mortality rates', 'cytokine levels, markers of brain, cardiac, kidney and liver damage, hemodynamic and hemostatic function, adverse events, and follow-up assessment of cerebral function and mortality', 'C-reactive protein (CRP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009421', 'cui_str': 'Coma'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0150158', 'cui_str': 'Cardiac care'}, {'cui': 'C0439148', 'cui_str': 'Unit'}]","[{'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0020674', 'cui_str': 'Induction of hypothermia'}, {'cui': 'C0042397', 'cui_str': 'Vasoconstrictor agent'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0362063', 'cui_str': 'Other prophylactic chemotherapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1609165', 'cui_str': 'tocilizumab'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0151763', 'cui_str': 'Liver damage'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0234386', 'cui_str': 'Cerebral function'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}]",80.0,0.655694,"Elevated levels of circulating interleukin-6 (IL-6), a pro-inflammatory cytokine, is associated with worse outcomes in OHCA patients, including higher vasopressor requirements and higher mortality rates.","[{'ForeName': 'Martin A S', 'Initials': 'MAS', 'LastName': 'Meyer', 'Affiliation': 'Department of Cardiology, The Heart Centre, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark. martin.abild.stengaard.meyer@regionh.dk.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Wiberg', 'Affiliation': 'Department of Cardiology, The Heart Centre, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Grand', 'Affiliation': 'Department of Cardiology, The Heart Centre, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Jesper', 'Initials': 'J', 'LastName': 'Kjaergaard', 'Affiliation': 'Department of Cardiology, The Heart Centre, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hassager', 'Affiliation': 'Department of Cardiology, The Heart Centre, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.'}]",Trials,['10.1186/s13063-020-04783-4']
1948,33081849,Safety and efficacy of antiviral combination therapy in symptomatic patients of Covid-19 infection - a randomised controlled trial (SEV-COVID Trial): A structured summary of a study protocol for a randomized controlled trial.,"OBJECTIVES


1. To compare the safety and efficacy of Hydroxychloroquine with Ribavirin and standard treatment in patients with non-severe COVID-19 infection 2. To compare the safety and efficacy of standard treatment, Lopinavir-ritonavir with Ribavarin, and Hydroxychloroquine with Ribavirin in patients with severe COVID-19 infection TRIAL DESIGN: The study is an Open label, Parallel arm design, stratified randomised controlled trial. Patients will be categorised as non-severe or severe based on predefined criteria. Those who satisfy all inclusion criteria and no exclusion criteria in the respective categories, will be randomly assigned to one of the three treatment groups in a ratio of 1:1 in the non-severe category and 1:1:1 in the severe category.
PARTICIPANTS


The trial will be undertaken in a tertiary care center of the country where both Covid and non-Covid patients are getting treated. All patients who are confirmed positive and admitted will be screened for the eligibility criteria and will be enrolled in the study after a written informed consent. Patients will be categorised as non-severe or severe based on predefined criteria.
INCLUSION CRITERIA (ALL REQUIRED)


1. Age ≥18 years at time of participation in the study 2. Laboratory (RT-PCR) confirmed infection with SARS-CoV-2 3. Symptomatic (severe or non-severe) Covid-19 disease 4. Willingness of study participant to accept randomization to any assigned treatment arm EXCLUSION CRITERIA: 1. Use of medications that are contraindicated with Lopinavir/Ritonavir, Hydroxychloroquine/Chloroquine, or Ribavirin and that cannot be replaced or stopped 2. Patient already on antiretroviral therapy with Lopinavir-Ritonavir based regimen or on Hydroxychloroquine/Chloroquine or on Ribavirin 3. Any known contraindication to test drugs such as retinopathy and QT prolongation 4. Known allergic reaction or inability to take orally of Lopinavir-ritonavir, Hydroxychloroquine/ Chloroquine, Ribavarin 5. Pregnant or breastfeeding females 6. Receipt of any experimental treatment for 2019-nCoV (off-label, compassionate use, or trial related) within 30 days prior to participation in the present study or want to participate after enrolment INTERVENTION AND COMPARATOR: Two therapeutic interventions for non-severe category and three for severe category as described below NON-SEVERE TREATMENT ARMS (NS-GROUP): Treatment Arm Drug A Standard Treatment (ST NS ) B Hydroxychloroquine 400 mg twice on first day followed by 400 mg per oral daily for 10 days + Ribavirin (1.2 g orally as a loading dose followed by 600mg orally every 12 hours) for 10 days + Standard Treatment (ST NS ) Standard Treatment for non-severe cases (STNS): Strict Isolation, Standard Precautions (Hand hygiene, Cough Etiquette, Wear surgical mask), Hydration, Proper Nutrition, Supportive Pharmacotherapy (Antipyretic, Antiallergic, Cough Suppressant), Treatment of Comorbid Diseases, Oseltamivir (75 mg BD) for patients who are tested positive for H1N1.
SEVERE GROUP TREATMENT ARMS (S-GROUP)


Treatment Arm Drug A Standard Treatment (ST s ) B Hydroxychloroquine 400mg BD on day1 followed by 400 mg once daily + Ribavirin (1.2 g orally as a loading dose followed by 600mg orally every 12 hours) for 10 days + Standard Treatment (ST s ) C Lopinavir(200mg) + Ritonavir (50mg) two tablets twice daily+ Ribavirin (1.2g orally as a loading dose followed by 600mg orally every 12 hours) for 10 days + Standard Treatment (ST s ) 6  Standard Treatment for severe patients (STs): Strict Isolation, Standard Precautions (Hand hygiene, Cough Etiquette, Wear surgical mask), Fluid Therapy, Supportive Pharmacotherapy (Antipyretic, Antiallergic, Cough Suppressant), Oxygen supplementation (As required), Invasive ventilation (As required), Antibiotic agents for other associated infections (according to 2019 ATS/IDSA guidelines for non-ICU and ICU patients), Vasopressor support, Renal-replacement therapy, Treatment of Comorbid Diseases, Oseltamivir (75 mg BD) for patients who are tested positive for H1N1.
MAIN OUTCOMES


Primary endpoints: (1) Time to Clinical recovery (TTCR) defined as the time (in hours) from initiation of study treatment (active or placebo) until normalisation of fever, respiratory rate, oxygen saturation, and alleviation of cough, sustained for at least 72 hours. (2) Time to SARS-CoV-2 RT-PCR negative in upper respiratory tract specimen, time to laboratory recovery of each organ involvement. Secondary Endpoints: All causes mortality, Frequency of respiratory progression (defined as SPO2≤ 94% on room air or PaO2/FiO2 <300mmHg and requirement for supplemental oxygen or more advanced ventilator support), time to defervescence (in those with fever at enrolment), frequency of requirement for supplemental oxygen or non-invasive ventilation, frequency of requirement for mechanical ventilation, frequency of serious adverse events as per DAIDS table grade of severity. Outcomes are monitored for 28 days from the time of enrolment into the study OR until the patient is discharged or death whichever is longer.
RANDOMIZATION


The randomization will be done using a secured central computer-based randomization using a secure website using a central, computer-based randomisation program in a ratio of 1:1 in the non-severe category and 1:1:1 in the severe category.
BLINDING (MASKING)


This is an open labelled study i.e. Study assigned treatment will be known to the research team, the investigators and participants.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)


Since it is an exploratory trial as COVID-19 being a new disease, all patients who came under the purview of the inclusion criteria within the study period (5 months duration of the recruitment period of the total 6 months duration of the study i.e. from the month of June, 2020 to October 2020) and who have consented for the study will be included.
TRIAL STATUS


Protocol version:1.0 Recruitment start: June 3 rd , 2020 (Ongoing) Recruitment finish (expected): October 31 st , 2020 TRIAL REGISTRATION: Clinical Trial Registry of India (CTRI): CTRI/2020/06/025575 . Registration on 03 June 2020 FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this letter serves as a summary of the key elements of the full protocol.",2020,Laboratory (RT-PCR) confirmed infection with SARS-CoV-2 3.,"['patients with non-severe COVID-19 infection 2', 'Age ≥18 years at time of participation in the study 2', 'patients with severe COVID-19 infection', 'patients who came under the purview of the inclusion criteria within the study period (5 months duration of the recruitment period of the total 6 months duration of the study i.e. from the month of June, 2020 to October 2020) and who have consented for the study will be included', '03 June 2020', 'Pregnant or breastfeeding females 6', 'symptomatic patients of Covid-19 infection - a randomised controlled trial (SEV-COVID Trial', 'All patients who are confirmed positive and admitted will be screened for the eligibility criteria and will be enrolled in the study after a written informed consent', 'patients who are tested positive for H1N1', 'non-severe cases (STNS']","['antiviral combination therapy', 'B Hydroxychloroquine', 'Hydroxychloroquine/Chloroquine', 'Lopinavir-ritonavir with Ribavarin, and Hydroxychloroquine with Ribavirin', 'Fluid Therapy, Supportive Pharmacotherapy (Antipyretic, Antiallergic, Cough Suppressant), Oxygen supplementation (As required), Invasive ventilation (As required), Antibiotic agents for other associated infections (according to 2019 ATS/IDSA guidelines for non-ICU and ICU patients), Vasopressor support, Renal-replacement therapy, Treatment of Comorbid Diseases, Oseltamivir', 'Hydroxychloroquine with Ribavirin', 'Hydroxychloroquine', ' Ribavirin', 'Ribavirin 3', 'Ritonavir', 'Ribavirin', 'Lopinavir/Ritonavir, Hydroxychloroquine/Chloroquine, or Ribavirin', 'daily+ Ribavirin', 'Lopinavir-Ritonavir', 'Drug A Standard Treatment (ST NS ', 'Lopinavir-ritonavir, Hydroxychloroquine/ Chloroquine, Ribavarin 5']","['Safety and efficacy', 'safety and efficacy', 'mortality, Frequency of respiratory progression', '1) Time to Clinical recovery (TTCR) defined as the time (in hours) from initiation of study treatment (active or placebo) until normalisation of fever, respiratory rate, oxygen saturation, and alleviation of cough, sustained for at least 72 hours']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0960273', 'cui_str': 'CAME'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0580264', 'cui_str': 'H1N1'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0003451', 'cui_str': 'Antiviral'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0008269', 'cui_str': 'Chloroquine'}, {'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}, {'cui': 'C0035525', 'cui_str': 'Ribavirin'}, {'cui': 'C0016286', 'cui_str': 'Therapy, Fluid'}, {'cui': 'C0436313', 'cui_str': 'Supportive pharmacotherapy'}, {'cui': 'C0003419', 'cui_str': 'Antipyretic Agents'}, {'cui': 'C0282555', 'cui_str': 'Antiallergy Agents'}, {'cui': 'C0003449', 'cui_str': 'Antitussive agent'}, {'cui': 'C0919655', 'cui_str': 'Oxygen supplementation'}, {'cui': 'C0558288', 'cui_str': 'As required'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042397', 'cui_str': 'Vasoconstrictor agent'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0874161', 'cui_str': 'Oseltamivir'}, {'cui': 'C0292818', 'cui_str': 'Ritonavir'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C1292423', 'cui_str': '72 hours'}]",,0.180975,Laboratory (RT-PCR) confirmed infection with SARS-CoV-2 3.,"[{'ForeName': 'Prasan Kumar', 'Initials': 'PK', 'LastName': 'Panda', 'Affiliation': 'General Medicine, AIIMS Rishikesh, Rishikesh, India. prasan.med@aiimsrishikesh.edu.in.'}, {'ForeName': 'Arkapal', 'Initials': 'A', 'LastName': 'Bandyopadhyay', 'Affiliation': 'Department of Pharmacology, AIIMS Rishikesh, Rishikesh, India.'}, {'ForeName': 'Budha Charan', 'Initials': 'BC', 'LastName': 'Singh', 'Affiliation': 'Department of Medicine, AIIMS Rishikesh, Rishikesh, India.'}, {'ForeName': 'Bikram', 'Initials': 'B', 'LastName': 'Moirangthem', 'Affiliation': 'Department of Medicine, AIIMS Rishikesh, Rishikesh, India.'}, {'ForeName': 'Gaurav', 'Initials': 'G', 'LastName': 'Chikara', 'Affiliation': 'Department of Pharmacology, AIIMS Rishikesh, Rishikesh, India.'}, {'ForeName': 'Sarama', 'Initials': 'S', 'LastName': 'Saha', 'Affiliation': 'Biochemistry, AIIMS Rishikesh, Rishikesh, India.'}, {'ForeName': 'Yogesh Arvind', 'Initials': 'YA', 'LastName': 'Bahurupi', 'Affiliation': 'Community and Family Medicine, AIIMS Rishikesh, Rishikesh, India.'}]",Trials,['10.1186/s13063-020-04774-5']
1949,33081894,[Effect of different fluid resuscitation strategies on renal function in patients with septic shock induced acute kidney injury].,"OBJECTIVE


To compare the therapeutic effect of fluid resuscitation strategy guided by pulse-indicated continuous cardiac output (PiCCO) monitoring and early goal-directed therapy (EGDT) on renal function of acute kidney injury (AKI) patients caused by septic shock.
METHODS


Septic shock patients with AKI admitted to the intensive care unit (ICU) of Tianjin Fifth Central Hospital and Teda International Cardiovascular Hospital from March 2017 to February 2020 were enrolled. All patients were given fluid resuscitation. Patients were divided into PiCCO-guided fluid resuscitation group [PiCCO group, intrathoracic blood volume index (ITBVI) was maintained between 850-1 000 mL/m 2 ] and EGDT-guided fluid resuscitation group [EGDT group, central venous pressure (CVP) was maintained between 8-12 mmHg (1 mmHg = 0.133 kPa) or CVP ≤ 15 mmHg when patients received mechanical ventilation (MV)] according to both the patient's condition and the informed consent of the patient's family. The changes of heart rate (HR), mean arterial pressure (MAP), CVP, blood lactic acid (Lac), fluid balance, urine volume and serum creatinine (SCr) at 6, 24, and 48 hours after fluid resuscitation in the two groups were observed, and the renal replacement therapy (RRT), duration of MV, length of ICU stay and 28-day mortality between the two group were compared.
RESULTS


(1) A total of 94 patients were enrolled, including 51 in the EGDT group and 43 in the PiCCO group. There was no significant difference in gender, age, acute physiology and chronic health evaluation II (APACHE II) score, sequential organ failure assessment (SOFA) score, procalcitonin (PCT), HR, MAP, CVP, Lac or SCr at ICU admission between the two groups. (2) The parameters of hemodynamics, fluid balance, urine volume and SCr were improved with the time of resuscitation in the two groups, and there was no significant difference in HR, MAP or Lac between the two groups. Compared with the EGDT group, the CVP decreased significantly at 24 hours and 48 hours after fluid resuscitation in the PiCCO group (mmHg: 9.1±0.9 vs. 12.0±1.3 at 24 hours, 8.0±1.0 vs. 10.2±1.3 at 48 hours), the fluid balance significantly decreased (mL: 2 929.8±936.3 vs. 3 898.4±923.5 at 24 hours, 3 143.5±1 325.4 vs. 4 843.8±1 326.7 at 48 hours), and the condition of urine volume and SCr were better in the PiCCO group [urine volume (mL×kg -1 ×h -1 ): 1.02±0.21 vs. 0.79±0.14 at 24 hours, 1.28±0.18 vs. 0.94±0.22 at 48 hours; SCr (μmol/L): 145.7±37.6 vs. 164.3±46.4 at 24 hours, 128.4±33.6 vs. 143.5±37.7 at 48 hours), with significant differences (all P < 0.05). (3) Compared with the EGDT group, the rate of RRT in the PiCCO group was lower [11.6% (5/43) vs. 17.6% (9/51)], the duration of MV and the length of ICU stay were shorter [duration of MV (days): 4.64±1.31 vs. 6.50±2.19, length of ICU stay (days): 10.35±3.50 vs. 14.50±5.78), with significant differences (all P < 0.05). There was no significant difference in the 28-day mortality between the PiCCO group and EGDT group [14.0% (6/43) vs. 15.7% (8/51), P > 0.05].
CONCLUSIONS


Fluid resuscitation strategy guided by PiCCO in septic shock patients with AKI can reduce the amount of fluid load, improve renal function, shorten the MV duration and length of ICU stay, and shows clinical significance.",2020,"There was no significant difference in gender, age, acute physiology and chronic health evaluation II (APACHE II) score, sequential organ failure assessment (SOFA) score, procalcitonin (PCT), HR, MAP, CVP, Lac or SCr at ICU admission between the two groups.","['Septic shock patients with AKI admitted to the intensive care unit (ICU) of Tianjin Fifth Central Hospital and Teda International Cardiovascular Hospital from March 2017 to February 2020 were enrolled', 'septic shock patients with AKI', 'acute kidney injury (AKI) patients caused by septic shock', '94 patients were enrolled, including 51 in the EGDT group and 43 in the PiCCO group', 'patients with septic shock induced acute kidney injury']","['fluid resuscitation strategy guided by pulse-indicated continuous cardiac output (PiCCO) monitoring and early goal-directed therapy (EGDT', 'PiCCO-guided fluid resuscitation group [PiCCO group, intrathoracic blood volume index (ITBVI) was maintained between 850-1 000 mL/m 2 ] and EGDT-guided fluid resuscitation group [EGDT group, central venous pressure (CVP', 'CVP', 'mechanical ventilation (MV', 'EGDT', 'PiCCO', 'fluid resuscitation strategies']","['parameters of hemodynamics, fluid balance, urine volume and SCr', 'renal function', 'renal replacement therapy (RRT), duration of MV, length of ICU stay and 28-day mortality', 'CVP', 'renal function, shorten the MV duration and length of ICU stay', 'rate of RRT', '28-day mortality', 'HR, MAP or Lac', 'gender, age, acute physiology and chronic health evaluation II (APACHE II) score, sequential organ failure assessment (SOFA) score, procalcitonin (PCT), HR, MAP, CVP, Lac or SCr at ICU admission', 'heart rate (HR), mean arterial pressure (MAP), CVP, blood lactic acid (Lac), fluid balance, urine volume and serum creatinine (SCr', 'condition of urine volume and SCr', 'duration of MV and the length of ICU stay', 'fluid balance']","[{'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0205439', 'cui_str': 'Fifth'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4505227', 'cui_str': 'Early Goal-Directed Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]","[{'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C4505227', 'cui_str': 'Early Goal-Directed Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0595836', 'cui_str': 'Intrathoracic route'}, {'cui': 'C0005850', 'cui_str': 'Blood volume'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C3840657', 'cui_str': '850'}, {'cui': 'C0199666', 'cui_str': 'Measurement of central venous pressure'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0016284', 'cui_str': 'Fluid balance'}, {'cui': 'C0232856', 'cui_str': 'Rate of urine output, function'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0199666', 'cui_str': 'Measurement of central venous pressure'}, {'cui': 'C0441636', 'cui_str': 'Surgical shortening - action'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0064582', 'cui_str': 'lactic acid'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0243028', 'cui_str': 'Acute physiology and chronic health evaluation II'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3494459', 'cui_str': 'Sequential organ failure assessment score'}, {'cui': 'C0072027', 'cui_str': 'Procalcitonin'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0853170', 'cui_str': 'Blood lactic acid'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",94.0,0.0406967,"There was no significant difference in gender, age, acute physiology and chronic health evaluation II (APACHE II) score, sequential organ failure assessment (SOFA) score, procalcitonin (PCT), HR, MAP, CVP, Lac or SCr at ICU admission between the two groups.","[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Intensive Care Unit, Teda International Cardiovascular Hospital, Tianjin 300450, China.'}, {'ForeName': 'Qingguo', 'Initials': 'Q', 'LastName': 'Feng', 'Affiliation': 'Department of Critical Care Medicine, the Fifth Central Hospital in Tianjin, Tianjin 300457, China. Corresponding author: Yang Wanjie, Email: yangwanjie0709@126.com.'}, {'ForeName': 'Wanjie', 'Initials': 'W', 'LastName': 'Yang', 'Affiliation': 'Department of Critical Care Medicine, the Fifth Central Hospital in Tianjin, Tianjin 300457, China. Corresponding author: Yang Wanjie, Email: yangwanjie0709@126.com.'}, {'ForeName': 'Yanxu', 'Initials': 'Y', 'LastName': 'Liang', 'Affiliation': 'Department of Critical Care Medicine, the Fifth Central Hospital in Tianjin, Tianjin 300457, China. Corresponding author: Yang Wanjie, Email: yangwanjie0709@126.com.'}, {'ForeName': 'Zhipeng', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Intensive Care Unit, Teda International Cardiovascular Hospital, Tianjin 300450, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Intensive Care Unit, Teda International Cardiovascular Hospital, Tianjin 300450, China.'}]",Zhonghua wei zhong bing ji jiu yi xue,['10.3760/cma.j.cn121430-20200717-00529']
1950,33082033,"Corrigendum to ""Fixed-dose combination of indacaterol/glycopyrronium/mometasone furoate once-daily versus salmeterol/fluticasone twice-daily plus tiotropium once-daily in patients with uncontrolled asthma: A randomised, Phase IIIb, non-inferiority study (ARGON)"" [Respir. Med. 170 (Aug-Sep 2020) 106021].",,2020,,"['170', 'patients with uncontrolled asthma']","['indacaterol/glycopyrronium/mometasone furoate', 'salmeterol/fluticasone twice-daily plus tiotropium']",[],"[{'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}]","[{'cui': 'C1722260', 'cui_str': 'indacaterol'}, {'cui': 'C3814772', 'cui_str': 'glycopyrronium'}, {'cui': 'C0066700', 'cui_str': 'Mometasone furoate'}, {'cui': 'C0073992', 'cui_str': 'salmeterol'}, {'cui': 'C0082607', 'cui_str': 'fluticasone'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0213771', 'cui_str': 'tiotropium'}]",[],,0.307449,,"[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Gessner', 'Affiliation': 'Universitätsklinikum Leipzig, Germany POIS Leipzig GbR, Leipzig, Germany. Electronic address: studien@pois-le.de.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Kornmann', 'Affiliation': 'IKF Pneumologie Frankfurt, Clinical Research Centre Respiratory Diseases, Frankfurt, Germany.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Maspero', 'Affiliation': 'Allergy and Respiratory Research Unit, Fundación CIDEA, Buenos Aires, Argentina.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'van Zyl-Smit', 'Affiliation': 'Division of Pulmonology and UCT Lung Institute, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Krüll', 'Affiliation': 'Institut für Allergie- und Asthmaforschung Berlin, IAAB, Germany.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Salina', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Pritam', 'Initials': 'P', 'LastName': 'Gupta', 'Affiliation': 'Novartis Healthcare Pvt. Ltd, Hyderabad, India.'}, {'ForeName': 'Sebastien', 'Initials': 'S', 'LastName': 'Bostel', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Fucile', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, United States.'}, {'ForeName': 'Lorena Garcia', 'Initials': 'LG', 'LastName': 'Conde', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Pfister', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}]",Respiratory medicine,['10.1016/j.rmed.2020.106186']
1951,33082099,Population pharmacokinetic and exposure-response analyses of d-amphetamine after administration of lisdexamfetamine dimesylate in Japanese pediatric ADHD patients.,"Lisdexamfetamine dimesylate, a prodrug of d-amphetamine, has been approved for treatment of attention-deficit/hyperactivity disorder (ADHD). The purposes of this study were constructing a population pharmacokinetic model of d-amphetamine after dosing of lisdexamfetamine dimesylate and assessing influential factors on the pharmacokinetics of d-amphetamine in Japanese pediatric patients with ADHD. Additionally, the exposure-response relationship was evaluated for Japanese pediatric patients with ADHD using a clinical rating scale, the ADHD Rating Scale IV (ADHD RS-IV, efficacy endpoint) total score as a response index. A total of 1365 points of plasma d-amphetamine concentrations from pediatric patients (6-17 years) with ADHD in clinical studies conducted in Japan and the US were employed for the population pharmacokinetic analysis. The plasma concentrations of d-amphetamine in pediatric patients with ADHD were well described by a one-compartment model with first-order absorption and lag time. The effects of body weight and ethnicity (Japanese or non-Japanese) on apparent total body clearance and the effect of body weight on apparent volume of distribution were incorporated into the final model. No clear exposure-dependent reduction was evident from the ADHD RS-IV total score, whereas the reductions were greater for the lisdexamfetamine dimesylate treatment groups compared with the placebo group regardless of exposure to d-amphetamine.",2020,The plasma concentrations of d-amphetamine in pediatric patients with ADHD were well described by a one-compartment model with first-order absorption and lag time.,"['Japanese pediatric ADHD patients', 'pediatric patients (6-17 years) with ADHD in clinical studies conducted in Japan and the US were employed for the population pharmacokinetic analysis', 'pediatric patients with ADHD', 'Japanese pediatric patients with ADHD']","['body weight and ethnicity (Japanese or non-Japanese', 'Lisdexamfetamine dimesylate', 'placebo', 'amphetamine', 'lisdexamfetamine dimesylate']","['clinical rating scale, the ADHD Rating Scale IV (ADHD RS-IV, efficacy endpoint) total score as a response index', 'plasma concentrations of d-amphetamine', 'ADHD RS-IV total score']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C1739826', 'cui_str': 'Lisdexamfetamine dimesylate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0002658', 'cui_str': 'Amphetamine'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0011812', 'cui_str': 'Dextroamphetamine'}]",,0.0131383,The plasma concentrations of d-amphetamine in pediatric patients with ADHD were well described by a one-compartment model with first-order absorption and lag time.,"[{'ForeName': 'Yoshiyuki', 'Initials': 'Y', 'LastName': 'Tsuda', 'Affiliation': 'Clinical Pharmacology & Pharmacokinetics, Shionogi & Co., Ltd., Japan.'}, {'ForeName': 'Yumiko', 'Initials': 'Y', 'LastName': 'Matsuo', 'Affiliation': 'Clinical Pharmacology & Pharmacokinetics, Shionogi & Co., Ltd., Japan.'}, {'ForeName': 'Sayaka', 'Initials': 'S', 'LastName': 'Matsumoto', 'Affiliation': 'Clinical Pharmacology & Pharmacokinetics, Shionogi & Co., Ltd., Japan.'}, {'ForeName': 'Toshihiro', 'Initials': 'T', 'LastName': 'Wajima', 'Affiliation': 'Clinical Pharmacology & Pharmacokinetics, Shionogi & Co., Ltd., Japan. Electronic address: toshihiro.wajima@shionogi.co.jp.'}]",Drug metabolism and pharmacokinetics,['10.1016/j.dmpk.2020.08.005']
1952,33082178,Promoting early treatment for mild traumatic brain injury in primary care with a guideline implementation tool: a pilot cluster randomised trial.,"OBJECTIVES


New clinical practice guidelines for the management of mild traumatic brain injury (mTBI) emphasise that family physicians should proactively screen and initiate treatment for depression/anxiety, insomnia and headaches. This study aimed to evaluate the feasibility of delivering an implementation intervention to family physicians.
DESIGN


Pilot cluster randomised controlled trial.
SETTING


Specialty outpatient clinic (recruitment) and primary care (implementation).
PARTICIPANTS


114 primary care clinics were randomised. These clinics were associated with 137 unique family physicians caring for 148 adult patients who sustained an mTBI within the previous 3 months and were seeking care for persistent symptoms.
INTERVENTIONS


Patients completed self-report screening measures for depression/anxiety, insomnia and headaches. A tailored letter that incorporates the patient's screening test results and associated treatment algorithms was sent to their family physician (or walk-in clinic). Physicians at clinics assigned to the control condition received a generic letter, without the screening test results.
PRIMARY OUTCOME MEASURES


Feasibility outcomes included the frequency of primary care follow-up, retention rates and reliability of patient recall of their physicians' actions (primary mechanistic outcome). The primary efficacy outcome was the Rivermead Post-Concussion Symptom Questionnaire (RPQ).
RESULTS


Most patients (97.8%; 128 of 131) followed up at the primary care clinic they planned to. Retention rates were 88% (131 of 148) and 78% (116 of 148) at the 1-month and 3-month assessments, respectively. Agreement between patient recall of their physicians' actions and medical chart audits was moderate (intraclass correlation coefficient=0.48-0.65). Patients in the experimental group reported fewer symptoms on the RPQ compared with those in the control group, whose physician received a general letter (B=-4.0, 95% CI: -7.3 to -0.7).
CONCLUSIONS


A larger trial will need to address minor feasibility challenges to evaluate the effectiveness of this guideline implementation tool for improving mTBI clinical outcomes and confirm the mechanism(s) of intervention benefit.
TRIAL REGISTRATION NUMBER


NCT03221218.",2020,"Patients in the experimental group reported fewer symptoms on the RPQ compared with those in the control group, whose physician received a general letter (B=-4.0, 95% CI: -7.3 to -0.7).
","['Specialty outpatient clinic (recruitment) and primary care (implementation', '114 primary care clinics', '148 adult patients who sustained an mTBI within the previous 3 months and were seeking care for persistent symptoms']",['Patients completed self-report screening measures'],"[""frequency of primary care follow-up, retention rates and reliability of patient recall of their physicians' actions (primary mechanistic outcome"", 'RPQ', 'Retention rates', 'Rivermead Post-Concussion Symptom Questionnaire (RPQ', 'depression/anxiety, insomnia and headaches']","[{'cui': 'C0037778', 'cui_str': 'Medical specialty'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0006107', 'cui_str': 'Concussion injury of brain'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0546983', 'cui_str': 'Postconcussion syndrome'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0018681', 'cui_str': 'Headache'}]",148.0,0.0807941,"Patients in the experimental group reported fewer symptoms on the RPQ compared with those in the control group, whose physician received a general letter (B=-4.0, 95% CI: -7.3 to -0.7).
","[{'ForeName': 'Noah D', 'Initials': 'ND', 'LastName': 'Silverberg', 'Affiliation': 'Department of Psychology, The University of British Columbia, Vancouver, British Columbia, Canada noah.silverberg@ubc.ca.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Panenka', 'Affiliation': 'Department of Psychiatry, The University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Pierre-Paul', 'Initials': 'PP', 'LastName': 'Lizotte', 'Affiliation': 'Department of Family Medicine, Providence Health Care, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Bayley', 'Affiliation': 'Hull-Ellis Concussion Research Center, Toronto Rehabilitation Institute, Toronto, Ontario, Canada.'}, {'ForeName': 'Derry', 'Initials': 'D', 'LastName': 'Dance', 'Affiliation': 'Division of Physical Medicine and Rehabilitation, The University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Linda C', 'Initials': 'LC', 'LastName': 'Li', 'Affiliation': 'Arthritis Research Canada, Richmond, British Columbia, Canada.'}]",BMJ open,['10.1136/bmjopen-2019-035527']
1953,33082181,"While you're waiting, a waiting room-based, cardiovascular disease-focused educational program: protocol for a randomised controlled trial.","INTRODUCTION


Patients with cardiovascular disease (CVD) frequently attend outpatient clinics and spend a significant amount of time in waiting rooms. Currently, this time is poorly used. This study aims to investigate whether providing CVD and cardiopulmonary resuscitation (CPR) education to waiting patients in a cardiology clinic of a large referral hospital improves motivation to change health behaviours, CPR knowledge, behaviours and clinic satisfaction post clinic, and whether there is any impact on reported CVD lifestyle behaviours or relevant CPR outcomes at 30 days.
METHODS AND ANALYSIS


Randomised controlled trial with parallel design to be conducted among 330 patients in the waiting room of a chest pain clinic in a tertiary referral hospital. Intervention (n=220) participants will receive a tablet-delivered series of educational videos catered to self-reported topics of interest (physical activity, blood pressure, diet, medications, smoking and general health) and level of health knowledge. Control (n=110) participants will receive usual care. In a substudy, intervention participants will be randomised 1:1 to receive an extra video on CPR or no extra video. The primary outcome will be the proportion of intervention and control participants who report high motivation to improve physical activity, diet and blood pressure monitoring at end of clinic. The primary outcome of the CPR study will be confidence to perform CPR post clinic. Secondary analysis will examine impact on clinic satisfaction, lifestyle behaviours, CPR knowledge and willingness to perform CPR post clinic and at 30-day follow-up.
ETHICS AND DISSEMINATION


Ethics approval has been received from the Western Sydney Local Health District Human Research Ethics Committee. All patients will provide informed consent via a tablet-based eConsent framework. Study results will be disseminated via the usual channels including peer-reviewed publications and presentations at national and international conferences.
TRIAL REGISTRATION NUMBER


ANZCTR12618001725257.",2020,"The primary outcome will be the proportion of intervention and control participants who report high motivation to improve physical activity, diet and blood pressure monitoring at end of clinic.","['waiting patients in a cardiology clinic of a large referral hospital', 'Intervention (n=220', '330 patients in the waiting room of a chest pain clinic in a tertiary referral hospital', 'Patients with cardiovascular disease (CVD) frequently attend outpatient clinics']","['Control (n=110) participants will receive usual care', 'extra video on CPR or no extra video', 'CVD and cardiopulmonary resuscitation (CPR) education', 'tablet-delivered series of educational videos catered to self-reported topics of interest (physical activity, blood pressure, diet, medications, smoking and general health']","['clinic satisfaction, lifestyle behaviours, CPR knowledge and willingness to perform CPR post clinic and at 30-day follow-up', 'physical activity, diet and blood pressure monitoring at end of clinic']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3810847', 'cui_str': 'Cardiology clinic'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4517719', 'cui_str': '330'}, {'cui': 'C0008031', 'cui_str': 'Chest pain'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C1456498', 'cui_str': 'Attended'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0205549', 'cui_str': 'Series'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C1522168', 'cui_str': 'Topical route'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}]","[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0026426', 'cui_str': 'Blood pressure monitoring'}, {'cui': 'C0444930', 'cui_str': 'End'}]",330.0,0.138456,"The primary outcome will be the proportion of intervention and control participants who report high motivation to improve physical activity, diet and blood pressure monitoring at end of clinic.","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Mcintyre', 'Affiliation': 'Westmead Applied Research Centre, University of Sydney, Westmead, New South Wales, Australia daniel.mcintyre@sydney.edu.au.'}, {'ForeName': 'Aravinda', 'Initials': 'A', 'LastName': 'Thiagalingam', 'Affiliation': 'Westmead Applied Research Centre, University of Sydney, Westmead, New South Wales, Australia.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Chow', 'Affiliation': 'Westmead Applied Research Centre, University of Sydney, Westmead, New South Wales, Australia.'}]",BMJ open,['10.1136/bmjopen-2020-036780']
1954,33082217,Mechanical Insufflation-Exsufflation With Oscillations in Amyotrophic Lateral Sclerosis With Home Ventilation via Tracheostomy.,"BACKGROUND


Mechanical insufflation-exsufflation (MI-E) applied via tracheostomy tubes in patients with amyotrophic lateral sclerosis (ALS) who are on home mechanical ventilation via tracheostomy is an effective procedure for respiratory secretion management. Nonetheless, tenacious secretions may remain and increase the risk of respiratory infections. The aim of this study was to determine whether adding oscillations to MI-E could reduce the rate of respiratory infections and the need for bronchoscopy to remove secretions in patients with ALS on home mechanical ventilation via tracheostomy.
METHODS


This was a 2-y, prospective, crossover study. Subjects were treated with conventional MI-E and MI-E with oscillations for 2 alternate 6-month periods. Data were collected on episodes of respiratory infections, hospital admission, and number of bronchoscopy procedures.
RESULTS


In the 19 ALS subjects enrolled, the median (interquartile range [IQR]) number of acute respiratory infections per subject was 1.0 (0.5-2.0) in the MI-E period and 0.0 (0.0-2.0) in the MI-E plus oscillations period ( P  = .92). The median (IQR) number of hospital stays was 0.0 (0.0-1.0) in the MI-E period and 0.0 (0.0-1.0) in the MI-E plus oscillations period ( P  = .80). The median (IQR) number of bronchoscopies per subject was 0.0 (0.0-1.0) in MI-E period and 0.0 (0.0-0.5) in the MI-E plus oscillations period ( P  = .26). MI-E plus oscillations treatment had no impact on the risk of respiratory infections (odds ratio 3.71, 95% CI 0.81-16.84,  P  = .09) or the need for bronchoscopy (odds ratio 2.70, 95% CI 0.44-16.68,  P  = .29).
CONCLUSIONS


Adding oscillations to MI-E therapy in subjects with ALS on home mechanical ventilation via tracheostomy did not decrease the risk of respiratory infections, hospital admission, or need for bronchoscopy.",2020,"MI-E plus oscillations treatment had no impact on the risk of respiratory infections (odds ratio 3.71, 95% CI 0.81-16.84,  P  = .09) or the need for bronchoscopy (odds ratio 2.70, 95% CI 0.44-16.68,  P  = .29).
","['Amyotrophic Lateral Sclerosis With Home Ventilation via Tracheostomy', '19 ALS subjects enrolled', 'patients with amyotrophic lateral sclerosis (ALS', 'patients with ALS on home mechanical ventilation via tracheostomy', 'subjects with ALS']","['Mechanical Insufflation-Exsufflation With Oscillations', 'Mechanical insufflation-exsufflation (MI-E) applied via tracheostomy tubes', 'conventional MI-E and MI-E with oscillations']","['rate of respiratory infections', 'risk of respiratory infections, hospital admission, or need for bronchoscopy', 'episodes of respiratory infections, hospital admission, and number of bronchoscopy procedures', 'risk of respiratory infections', 'acute respiratory infections', 'median (IQR) number of bronchoscopies per subject', 'median (IQR) number of hospital stays']","[{'cui': 'C0002736', 'cui_str': 'Amyotrophic lateral sclerosis'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0393370', 'cui_str': 'Approach via tracheostomy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}]","[{'cui': 'C5192599', 'cui_str': 'Mechanical insufflation exsufflation'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0442463', 'cui_str': 'Approach via tracheostomy tube'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0035243', 'cui_str': 'Respiratory tract infection'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0006290', 'cui_str': 'Bronchoscopy'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0238990', 'cui_str': 'Acute lower respiratory tract infection'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",,0.0861529,"MI-E plus oscillations treatment had no impact on the risk of respiratory infections (odds ratio 3.71, 95% CI 0.81-16.84,  P  = .09) or the need for bronchoscopy (odds ratio 2.70, 95% CI 0.44-16.68,  P  = .29).
","[{'ForeName': 'Jesus', 'Initials': 'J', 'LastName': 'Sancho', 'Affiliation': 'Respiratory Care Unit, Respiratory Medicine Department, Hospital Clínico Universitario, Valencia, Spain. jesus.sancho@uv.es.'}, {'ForeName': 'Enric', 'Initials': 'E', 'LastName': 'Burés', 'Affiliation': 'Research Group for Respiratory Problems in Neuromuscular Diseases, INCLIVA Health Research Institute, Valencia, Spain.'}, {'ForeName': 'Santos', 'Initials': 'S', 'LastName': 'Ferrer', 'Affiliation': 'Respiratory Care Unit, Respiratory Medicine Department, Hospital Clínico Universitario, Valencia, Spain.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Lahosa', 'Affiliation': 'Research Group for Respiratory Problems in Neuromuscular Diseases, INCLIVA Health Research Institute, Valencia, Spain.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Signes-Costa', 'Affiliation': 'Research Group for Respiratory Problems in Neuromuscular Diseases, INCLIVA Health Research Institute, Valencia, Spain.'}, {'ForeName': 'Emilio', 'Initials': 'E', 'LastName': 'Servera', 'Affiliation': 'Research Group for Respiratory Problems in Neuromuscular Diseases, INCLIVA Health Research Institute, Valencia, Spain.'}]",Respiratory care,['10.4187/respcare.08145']
1955,33082219,Closed-Loop Oxygen Control Using a Novel Nasal High-Flow Device: A Randomized Crossover Trial.,"BACKGROUND


Oxygen administration is recommended for patients with hypoxemia to achieve a target  S   pO 2  range. Strategies to achieve this in clinical practice are suboptimal. We investigated automatic oxygen titration using a novel nasal high-flow device with closed-loop oxygen control. The objective of this proof-of-concept study was to determine whether closed-loop control was able to respond to desaturation and subsequent recovery in a controlled laboratory-based environment.
METHODS


We conducted a single-blind randomized crossover trial in adults with chronic respiratory disease who had a resting  S   pO 2  ≥ 92% and desaturated to < 90% during a 6-min walk test (6MWT). Nasal high-flow was administered during a 6MWT and a subsequent 10-min rest period with either room air, a fixed concentration of 28% oxygen, or oxygen titrated automatically using closed-loop control.
RESULTS


The study involved 42 subjects. Closed-loop control maintained  S   pO 2  within the target range of 92-96% for a mean (SD) duration of 54.4 ± 30.1% of the 6MWT and 67.3 ± 26.8% of the recovery period. The proportion of time spent with an  S   pO 2  in the target range during the 6MWT was significantly greater for closed-loop control compared to room air, with a difference of 26.0% (95% CI 17.7-34.2,  P  < .001); this proportion of time was not significantly different compared to the fixed concentration of 28% oxygen, with a difference of -8.2% (95% CI -16.5 to 0.1,  P  = .052). The proportion of time spent in the target range during the rest period was significantly greater compared to 28% oxygen, with a difference of 19.3% (95% CI 8.9-29.7,  P  < .001); this proportion of time was not significantly different compared to room air, with a difference of -9.3% (95% CI -19.7 to 1.0,  P  = .08).
CONCLUSIONS


This study provides proof-of-concept evidence that the novel nasal high-flow device with closed-loop control can respond to changes in  S   pO 2  outside a target saturation range using a model of exercise-induced desaturation and subsequent recovery.",2020,"The proportion of time spent with an  S   pO 2  in the target range during the 6MWT was significantly greater for closed-loop control compared to room air, with a difference of 26.0% (95% CI 17.7-34.2,  P  < .001); this proportion of time was not significantly different compared to the fixed concentration of 28% oxygen, with a difference of -8.2% (95% CI -16.5 to 0.1,  P  = .052).","['42 subjects', 'adults with chronic respiratory disease who had a resting  S   pO 2  ≥ 92% and desaturated to < 90% during a 6-min walk test (6MWT', 'patients with hypoxemia']","['Closed-Loop Oxygen Control Using a Novel Nasal High-Flow Device', 'automatic oxygen titration using a novel nasal high-flow device with closed-loop oxygen control', '6MWT and a subsequent 10-min rest period with either room air, a fixed concentration of 28% oxygen, or oxygen titrated automatically using closed-loop control']","['proportion of time spent', 'proportion of time']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0264220', 'cui_str': 'Chronic disease of respiratory system'}, {'cui': 'C0297199', 'cui_str': 'PO-2'}, {'cui': 'C0439087', 'cui_str': '<90'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}]","[{'cui': 'C0443183', 'cui_str': 'Closed loop'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}]",42.0,0.293189,"The proportion of time spent with an  S   pO 2  in the target range during the 6MWT was significantly greater for closed-loop control compared to room air, with a difference of 26.0% (95% CI 17.7-34.2,  P  < .001); this proportion of time was not significantly different compared to the fixed concentration of 28% oxygen, with a difference of -8.2% (95% CI -16.5 to 0.1,  P  = .052).","[{'ForeName': 'James Cp', 'Initials': 'JC', 'LastName': 'Harper', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand. james.harper@mrinz.ac.nz.'}, {'ForeName': 'Nethmi A', 'Initials': 'NA', 'LastName': 'Kearns', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Maijers', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Grace E', 'Initials': 'GE', 'LastName': 'Bird', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Braithwaite', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Nicholas P', 'Initials': 'NP', 'LastName': 'Shortt', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Allie', 'Initials': 'A', 'LastName': 'Eathorne', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Weatherall', 'Affiliation': 'University of Otago Wellington, Wellington, New Zealand.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Beasley', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}]",Respiratory care,['10.4187/respcare.08087']
1956,33082244,"Effects of Low-Fat, Mediterranean, or Low-Carbohydrate Weight Loss Diets on Serum Urate and Cardiometabolic Risk Factors: A Secondary Analysis of the Dietary Intervention Randomized Controlled Trial (DIRECT).","OBJECTIVE


Weight loss diets may reduce serum urate (SU) by lowering insulin resistance while providing cardiometabolic benefits, something urate-lowering drugs have not shown in trials. We aimed to examine the effects of weight loss diets on SU and cardiometabolic risk factors.
RESEARCH DESIGN AND METHODS


This secondary study of the Dietary Intervention Randomized Controlled Trial (DIRECT) used stored samples from 235 participants with moderate obesity randomly assigned to low-fat, restricted-calorie ( n  = 85); Mediterranean, restricted-calorie ( n  = 76); or low-carbohydrate, non-restricted-calorie ( n  = 74) diets. We examined SU changes at 6 and 24 months overall and among those with hyperuricemia (SU ≥416 μmol/L), a relevant subgroup at risk for gout.
RESULTS


Among all participants, average SU decreases were 48 μmol/L at 6 months and 18 μmol/L at 24 months, with no differences between diets ( P  > 0.05). Body weight, HDL cholesterol (HDL-C), total cholesterol:HDL-C ratio, triglycerides, and insulin concentrations also improved in all three groups ( P  < 0.05 at 6 months). Adjusting for covariates, changes in weight and fasting plasma insulin concentrations remained associated with SU changes ( P  < 0.05). SU reductions among those with hyperuricemia were 113, 119, and 143 μmol/L at 6 months for low-fat, Mediterranean, and low-carbohydrate diets (all  P  for within-group comparison < 0.001;  P  > 0.05 for between-group comparisons) and 65, 77, and 83 μmol/L, respectively, at 24 months (all  P  for within-group comparison < 0.01;  P  > 0.05 for between-group comparisons).
CONCLUSIONS


Nonpurine-focused weight loss diets may simultaneously improve SU and cardiovascular risk factors likely mediated by reducing adiposity and insulin resistance. These dietary options could provide personalized pathways to suit patient comorbidity and preferences for adherence.",2020,"Adjusting for covariates, changes in weight and fasting plasma insulin concentrations remained associated with SU changes ( P  < 0.05).","['235 participants with moderate obesity randomly assigned to low-fat, restricted-calorie ( n  = 85']","['Mediterranean, restricted-calorie ( n  = 76); or low-carbohydrate, non-restricted-calorie ( n  = 74) diets', 'weight loss diets', 'Low-Fat, Mediterranean, or Low-Carbohydrate Weight Loss Diets']","['adiposity and insulin resistance', 'weight and fasting plasma insulin concentrations', 'Serum Urate and Cardiometabolic Risk Factors', 'Body weight, HDL cholesterol (HDL-C), total cholesterol:HDL-C ratio, triglycerides, and insulin concentrations', 'average SU decreases', 'SU reductions']","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0242970', 'cui_str': 'Low fat diet'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0439259', 'cui_str': 'kcal'}]","[{'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0012167', 'cui_str': 'Weight reduction diet'}, {'cui': 'C0242970', 'cui_str': 'Low fat diet'}]","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0857690', 'cui_str': 'Plasma insulin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0202239', 'cui_str': 'Uric acid measurement'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol in high density lipoprotein subfraction 2'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",235.0,0.0512083,"Adjusting for covariates, changes in weight and fasting plasma insulin concentrations remained associated with SU changes ( P  < 0.05).","[{'ForeName': 'Chio', 'Initials': 'C', 'LastName': 'Yokose', 'Affiliation': 'Clinical Epidemiology Program, Division of Rheumatology, Allergy, and Immunology, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'McCormick', 'Affiliation': 'Clinical Epidemiology Program, Division of Rheumatology, Allergy, and Immunology, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Sharan K', 'Initials': 'SK', 'LastName': 'Rai', 'Affiliation': 'Arthritis Research Canada, Richmond, British Columbia, Canada.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Lu', 'Affiliation': 'Arthritis Research Canada, Richmond, British Columbia, Canada.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Curhan', 'Affiliation': ""Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Schwarzfuchs', 'Affiliation': 'Department of Emergency Medicine, Soroka University Medical Center, and Faculty of Health, Ben-Gurion University of the Negev, Beer Sheva, Israel.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Shai', 'Affiliation': 'S. Daniel Abraham Center for Health and Nutrition, Ben-Gurion University of the Negev, Beer Sheva, Israel.'}, {'ForeName': 'Hyon K', 'Initials': 'HK', 'LastName': 'Choi', 'Affiliation': 'Clinical Epidemiology Program, Division of Rheumatology, Allergy, and Immunology, Massachusetts General Hospital, Boston, MA hchoi@mgh.harvard.edu.'}]",Diabetes care,['10.2337/dc20-1002']
1957,33082245,Effect of Dapagliflozin in DAPA-HF According to Background Glucose-Lowering Therapy.,"OBJECTIVE


To determine whether the benefits of dapagliflozin in patients with heart failure and reduced ejection fraction (HFrEF) and type 2 diabetes in the Dapagliflozin And Prevention of Adverse-Outcomes in Heart Failure trial (DAPA-HF) varied by background glucose-lowering therapy (GLT).
RESEARCH DESIGN AND METHODS


We examined the effect of study treatment by the use or not of GLT and by GLT classes and combinations. The primary outcome was a composite of worsening heart failure (hospitalization or urgent visit requiring intravenous therapy) or cardiovascular death.
RESULTS


In the 2,139 type 2 diabetes patients, the effect of dapagliflozin on the primary outcome was consistent by GLT use or no use (hazard ratio 0.72 [95% CI 0.58-0.88] vs. 0.86 [0.60-1.23]; interaction  P  = 0.39) and across GLT classes.
CONCLUSIONS


In DAPA-HF, dapagliflozin improved outcomes irrespective of use or no use of GLT or by GLT type used in patients with type 2 diabetes and HFrEF.",2020,"In DAPA-HF, dapagliflozin improved outcomes irrespective of use or no use of GLT or by GLT type used in patients with type 2 diabetes and HFrEF.","['DAPA-HF', '2,139 type 2 diabetes patients', 'patients with heart failure and reduced ejection fraction (HFrEF) and type 2 diabetes in the Dapagliflozin And Prevention of Adverse-Outcomes in Heart Failure trial (DAPA-HF) varied by background glucose-lowering therapy (GLT']","['GLT', 'Dapagliflozin', 'dapagliflozin']",['composite of worsening heart failure (hospitalization or urgent visit requiring intravenous therapy) or cardiovascular death'],"[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0455142', 'cui_str': 'Intravenous therapy'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.120672,"In DAPA-HF, dapagliflozin improved outcomes irrespective of use or no use of GLT or by GLT type used in patients with type 2 diabetes and HFrEF.","[{'ForeName': 'Kieran F', 'Initials': 'KF', 'LastName': 'Docherty', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, Glasgow, U.K.'}, {'ForeName': 'Pardeep S', 'Initials': 'PS', 'LastName': 'Jhund', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, Glasgow, U.K.'}, {'ForeName': 'Olof', 'Initials': 'O', 'LastName': 'Bengtsson', 'Affiliation': 'AstraZeneca R&D, Gothenburg, Sweden.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'DeMets', 'Affiliation': 'Department of Biostatistics and Medical Informatics, University of Wisconsin, Madison, WI.'}, {'ForeName': 'Silvio E', 'Initials': 'SE', 'LastName': 'Inzucchi', 'Affiliation': 'Section of Endocrinology, Yale University School of Medicine, New Haven, CT.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Køber', 'Affiliation': 'Rigshospitalet Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Mikhail N', 'Initials': 'MN', 'LastName': 'Kosiborod', 'Affiliation': ""Saint Luke's Mid America Heart Institute and University of Missouri-Kansas City, Kansas City, MO.""}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Langkilde', 'Affiliation': 'AstraZeneca R&D, Gothenburg, Sweden.'}, {'ForeName': 'Felipe A', 'Initials': 'FA', 'LastName': 'Martinez', 'Affiliation': 'National University of Cordoba, Cordoba, Argentina.'}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Sabatine', 'Affiliation': ""Thrombolysis in Myocardial Infarction Clinical Trials Study Group, Cardiovascular Division, Brigham and Women's Hospital and Harvard Medical School, Boston, MA.""}, {'ForeName': 'Mikaela', 'Initials': 'M', 'LastName': 'Sjöstrand', 'Affiliation': 'AstraZeneca R&D, Gothenburg, Sweden.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes care,['10.2337/dc20-1402']
1958,33089598,The appropriate cutoff gastric pH value for Helicobacter pylori eradication with bismuth-based quadruple therapy.,"BACKGROUND


This study aimed to investigate whether an increased proton pump inhibitor (PPI) dose enhanced the efficacy of Helicobacter pylori (H. pylori) eradication and determine the appropriate cutoff intragastric pH value that could predict H. pylori eradication with bismuth-based quadruple therapy.
MATERIALS AND METHODS


A total of 207 H. pylori infected, treatment naive patients were enrolled in this prospective, open-label, randomized controlled trial. Patients were randomly allocated into Eso40-group (esomeprazole 40 mg bid) and Eso20-group (esomeprazole 20 mg bid), and their CYP2C19 genotyping status was assessed. The 24-h intragastric pH monitoring on day 7 was performed, and percentage of time gastric pH ≥ 3, ≥4, ≥5, and ≥6 (pH holding time ratios; HTRs) were measured. H. pylori eradication was evaluated using  13  C-urea breath test.
RESULTS


No significant difference in the eradication rates was observed between two groups. The median 24-h intragastric pH value was not significant different between two groups but the Eso40 Group had a significant higher pH4 HTRs (91.11% [95%CI: 87.50%-95.83%] vs. 95.83% [95.83%-100%]; p = .002). Additionally, the median 24-h intragastric pH value showed significantly difference between two groups in EM genotype (Eso20 Group 6.00 [95%CI; 5.75-6.15] vs. Eso40 Group 6.30 [6.05-6.30]; p = .019). Similar results were observed in pH4 HTRs. There were significant differences in intragastric pH value (6.10 [95%CI: 4.40-7.00] vs. 5.65 [4.85-5.95], p = .038) and in pH4 HTRs (96% [95%CI: 92.00%-96.00%] vs. 87.5% [67.00%-100.0%], p = .019) between eradication-successful and eradication-failed patients. Statistical analysis suggested that the median intragastric pH = 5.7 could identify the success of H. pylori eradication.
CONCLUSIONS


Bismuth-based quadruple therapy resulted in high H. pylori eradication rates either in PPI standard or double doses. Double dose of esomeprazole is associated with better intragastric acid suppression. A median 24-h intragastric pH of 5.7 could be appropriate cutoff value for predicting the successful H. pylori eradication.",2020,The median 24-h intragastric pH value was not significant different between two groups but the Eso40 Group had a significant higher pH4 HTRs (91.11% [95%CI: 87.50%-95.83%] vs. 95.83% [95.83%-100%]; p = .002).,"['A total of 207 H.\xa0pylori infected, treatment naive patients']","['esomeprazole', 'Bismuth-based quadruple therapy', 'bismuth-based quadruple therapy', 'proton pump inhibitor (PPI', 'Eso40-group (esomeprazole 40\xa0mg bid) and Eso20-group (esomeprazole']","['median 24-h intragastric pH value', 'H.\xa0pylori eradication', 'pH4 HTRs', 'high H.\xa0pylori eradication rates', 'eradication rates', 'intragastric pH value', 'percentage of time gastric pH\xa0≥\xa03, ≥4, ≥5, and ≥6 (pH holding time ratios; HTRs']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0937846', 'cui_str': 'Esomeprazole'}, {'cui': 'C0005642', 'cui_str': 'Bismuth'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205175', 'cui_str': 'Quadruple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1127610', 'cui_str': 'Esomeprazole 40 MG'}, {'cui': 'C0048106', 'cui_str': ""4-benzamido-4'-isothiocyanostilbene-2,2'-disulfonate""}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0442113', 'cui_str': 'Intragastric'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1168023', 'cui_str': 'Gastric pH'}, {'cui': 'C0675390', 'cui_str': 'ARID1A protein, human'}, {'cui': 'C1264675', 'cui_str': 'Time ratio'}]",,0.0733339,The median 24-h intragastric pH value was not significant different between two groups but the Eso40 Group had a significant higher pH4 HTRs (91.11% [95%CI: 87.50%-95.83%] vs. 95.83% [95.83%-100%]; p = .002).,"[{'ForeName': 'Haoran', 'Initials': 'H', 'LastName': 'Ke', 'Affiliation': 'Department of Gastroenterology, State Key Laboratory of Organ Failure Research, Guangdong Provincial Key Laboratory of Gastroenterology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Gastroenterology, State Key Laboratory of Organ Failure Research, Guangdong Provincial Key Laboratory of Gastroenterology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Bingyun', 'Initials': 'B', 'LastName': 'Lu', 'Affiliation': 'Department of Gastroenterology, State Key Laboratory of Organ Failure Research, Guangdong Provincial Key Laboratory of Gastroenterology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Chenghai', 'Initials': 'C', 'LastName': 'Yang', 'Affiliation': 'Department of Gastroenterology, State Key Laboratory of Organ Failure Research, Guangdong Provincial Key Laboratory of Gastroenterology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Jiamin', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Gastroenterology, State Key Laboratory of Organ Failure Research, Guangdong Provincial Key Laboratory of Gastroenterology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Zhiqing', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Gastroenterology, State Key Laboratory of Organ Failure Research, Guangdong Provincial Key Laboratory of Gastroenterology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Le', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Gastroenterology, State Key Laboratory of Organ Failure Research, Guangdong Provincial Key Laboratory of Gastroenterology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Gastroenterology, State Key Laboratory of Organ Failure Research, Guangdong Provincial Key Laboratory of Gastroenterology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}]",Helicobacter,['10.1111/hel.12768']
1959,33089619,Thermocoagulation versus cryotherapy for the treatment of cervical precancers.,"AIM


To compare thermocoagulation and cryotherapy for treatment of high-grade cervical intraepithelial neoplasia (CIN).
METHODS


From May 2017 to May 2018, women with CIN2/3 were randomized to thermocoagulation or cryotherapy at Peking University Shenzhen Hospital. Follow-up at 4 and 8 months included cytology and human papillomavirus (HPV) testing. Women who were HPV-positive or had atypical squamous cells of undetermined significance or higher-grade disease underwent colposcopy/biopsy.
RESULTS


Among 149 women enrolled, 74 were randomized to thermocoagulation, and 75 to cryotherapy (excluded four were immediately referred for thermocoagulation due to large lesions). At follow-up, there was no difference between the thermocoagulation and cryotherapy groups in HPV-negative (4/8 months: 72.5%/86.2% vs 68.6%/80.6%) and pathology-negative (97.1%/98.5% vs 94.3%/92.3%) rates (all P > 0.05). The cytology-negative rate was similar for thermocoagulation and cryotherapy at 4 months (79.7% vs 78.9%, P > 0.05), but higher for thermocoagulation at 8 months (100% vs 88.7%, P < 0.05). No lesions were observed among the four referral women at follow-up. As compared with cryotherapy, thermocoagulation was associated with shorter duration of treatment and less vaginal discharge, but higher pain during application and longer bleeding after treatment.
CONCLUSION


Thermocoagulation was as effective and safe as cryotherapy and might be easily applied to treat high-grade cervical lesions.",2020,"At follow-up, there was no difference between the thermocoagulation and cryotherapy groups in HPV-negative (4/8 months: 72.5%/86.2% vs 68.6%/80.6%) and pathology-negative (97.1%/98.5% vs 94.3%/92.3%) rates (all P > 0.05).","['high-grade cervical intraepithelial neoplasia (CIN', '149 women enrolled, 74 were randomized to thermocoagulation, and 75 to cryotherapy (excluded four were immediately referred for thermocoagulation due to large lesions', 'cervical precancers', 'From May 2017 to May 2018, women with CIN2/3', 'Women who were HPV-positive or had atypical squamous cells of undetermined significance or higher-grade disease underwent colposcopy/biopsy']","['thermocoagulation and cryotherapy', 'thermocoagulation or cryotherapy', 'Thermocoagulation versus cryotherapy']","['HPV-negative', 'cytology-negative rate', 'shorter duration of treatment and less vaginal discharge', 'pain during application and longer bleeding', 'pathology-negative']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0206708', 'cui_str': 'Cervical intraepithelial neoplasia'}, {'cui': 'C5191071', 'cui_str': '149'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0013804', 'cui_str': 'Electrocoagulation'}, {'cui': 'C4551716', 'cui_str': 'Cryotherapy'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0007868', 'cui_str': 'Dysplasia of cervix'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0521184', 'cui_str': 'Atypical squamous cells of undetermined significance'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009417', 'cui_str': 'Colposcopy'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}]","[{'cui': 'C0013804', 'cui_str': 'Electrocoagulation'}, {'cui': 'C4551716', 'cui_str': 'Cryotherapy'}]","[{'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0010818', 'cui_str': 'Cytology'}, {'cui': 'C0439593', 'cui_str': 'Short duration'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0227791', 'cui_str': 'Vaginal discharge'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}]",149.0,0.0391455,"At follow-up, there was no difference between the thermocoagulation and cryotherapy groups in HPV-negative (4/8 months: 72.5%/86.2% vs 68.6%/80.6%) and pathology-negative (97.1%/98.5% vs 94.3%/92.3%) rates (all P > 0.05).","[{'ForeName': 'Lyufang', 'Initials': 'L', 'LastName': 'Duan', 'Affiliation': 'Department of Gynecology and Obstetrics, Peking University Shenzhen Hospital, Shenzhen, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Du', 'Affiliation': 'Department of Gynecology and Obstetrics, Peking University Shenzhen Hospital, Shenzhen, China.'}, {'ForeName': 'Jerome L', 'Initials': 'JL', 'LastName': 'Belinson', 'Affiliation': 'Preventive Oncology International, Cleveland Heights, Ohio, USA.'}, {'ForeName': 'Zhihong', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Department of Gynecology and Obstetrics, Peking University Shenzhen Hospital, Shenzhen, China.'}, {'ForeName': 'Aimin', 'Initials': 'A', 'LastName': 'Xiao', 'Affiliation': 'Department of Gynecology and Obstetrics, Peking University Shenzhen Hospital, Shenzhen, China.'}, {'ForeName': 'Shuangyan', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Department of Gynecology and Obstetrics, Peking University Shenzhen Hospital, Shenzhen, China.'}, {'ForeName': 'Liwei', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': 'Department of Gynecology and Obstetrics, Peking University Shenzhen Hospital, Shenzhen, China.'}, {'ForeName': 'Chun', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Gynecology and Obstetrics, Peking University Shenzhen Hospital, Shenzhen, China.'}, {'ForeName': 'Xinfeng', 'Initials': 'X', 'LastName': 'Qu', 'Affiliation': 'Sanming Project of Medicine in Shenzhen Peking University, Shenzhen Hospital, Shenzhen, China.'}, {'ForeName': 'Ruifang', 'Initials': 'R', 'LastName': 'Wu', 'Affiliation': 'Department of Gynecology and Obstetrics, Peking University Shenzhen Hospital, Shenzhen, China.'}]",The journal of obstetrics and gynaecology research,['10.1111/jog.14520']
1960,33089699,Validation of the cognitive stimulation therapy (CST) program for people with dementia in Portugal.,"BACKGROUND


Cognitive Stimulation Therapy (CST) is considered a gold-standard, evidence-based and cost-effective approach to improve cognitive function and quality of life of people with mild to moderate dementia.
AIMS


To validate CST for the Portuguese population and test its effectiveness.
METHODS


A single-blind, multi-center, randomized controlled trial recruited 112 older people with dementia. The primary outcome measure was cognition and secondary measures were quality of life, communication, autonomy, anxiety, depression, and global functioning. We also explored whether CST benefits people differently according to context, gender and level of cognitive reserve.
RESULTS


Fifty-five people were randomized to the intervention and 57 to the control group. In the post-test, the intervention group significantly improved relative to controls in cognition (ADAS-Cog,  p  = 0.013), communication (HCS,  p  = 0.045), behaviour (CAPE-BRS,  p  = 0.017) and in global dementia rating (CDR,  p  = 0.008). Quality of life, depression and anxiety had no significant differences. The estimated number needed to treat was four for one to benefit a cognitive improvement (ADAS-Cog).
CONCLUSIONS


Group CST is valid for the Portuguese population with benefits for people with mild to moderate dementia.",2020,"In the post-test, the intervention group significantly improved relative to controls in cognition (ADAS-Cog,  p  = 0.013), communication (HCS,  p  = 0.045), behaviour (CAPE-BRS,  p  = 0.017) and in global dementia rating (CDR,  p  = 0.008).","['Fifty-five people', 'people with dementia in Portugal', '112 older people with dementia', 'people with mild to moderate dementia']","['cognitive stimulation therapy (CST) program', 'Cognitive Stimulation Therapy (CST', 'CST']","['quality of life, communication, autonomy, anxiety, depression, and global functioning', 'cognitive function and quality of life', 'Quality of life, depression and anxiety', 'global dementia rating', 'relative to controls in cognition (ADAS-Cog', 'behaviour (CAPE-BRS']","[{'cui': 'C0450382', 'cui_str': '55'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0032729', 'cui_str': 'Portugal'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}]","[{'cui': 'C0150174', 'cui_str': 'Cognitive stimulation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001457', 'cui_str': 'Adenosine deaminase'}, {'cui': 'C0009738', 'cui_str': 'Congo'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0054434', 'cui_str': 'caffeic acid phenethyl ester'}]",112.0,0.12707,"In the post-test, the intervention group significantly improved relative to controls in cognition (ADAS-Cog,  p  = 0.013), communication (HCS,  p  = 0.045), behaviour (CAPE-BRS,  p  = 0.017) and in global dementia rating (CDR,  p  = 0.008).","[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Alvares-Pereira', 'Affiliation': 'Health Sciences Institute, Portuguese Catholic University, Lisboa, Portugal.'}, {'ForeName': 'M V', 'Initials': 'MV', 'LastName': 'Silva-Nunes', 'Affiliation': 'Health Sciences Institute, Portuguese Catholic University, Lisboa, Portugal.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Spector', 'Affiliation': 'Clinical, Educational & Health Psychology, University College London, London, UK.'}]",Aging & mental health,['10.1080/13607863.2020.1836473']
1961,33089713,CO 2  laser and the genitourinary syndrome of menopause: a randomized sham-controlled trial.,"PURPOSE


This study aimed to clarify the efficacy of intravaginal CO 2 -laser treatment in postmenopausal women with genitourinary syndrome of menopause (GSM).
MATERIALS AND METHODS


This double - blind, randomized, sham-controlled trial included postmenopausal women diagnosed with GSM and bothersome dryness and dyspareunia. Treatment consisted of three sessions. Active CO 2 -laser treatments (active group) were compared to sham treatments (sham group) with the primary endpoints being changes in dryness and dyspareunia intensity, as assessed by the 10-cm visual analog scale. Secondary endpoints were as follows: changes in Female Sexual Function Index (FSFI; total score and all domains), itching, burning, dysuria, and Urogenital Distress Inventory (UDI-6); incidence of symptoms; and presence of adverse events. All outcomes were evaluated at baseline and 4 months post baseline.
RESULTS


Fifty-eight women (28 in the active group and 30 in the sham group) were eligible for inclusion. In the active group, dryness, dyspareunia, FSFI (total score), itching, burning, dysuria, and UDI-6 were significantly improved (mean [standard deviation] -5.6 [2.8], -6 [2.6], 12.3 [8.9], -2.9 [2.8], -2.3 [2.8], -0.9 [2.1], and -8.0 [15.3], respectively). In the sham group, dryness, itching, and burning were significantly improved (-1.9 [2], -1.4 [1.9], and -1 [1.9], respectively). All changes were in favor of the active group. After completion of the protocol, the proportion of participants with dryness, dyspareunia, and sexual dysfunction was significantly lower in the active group compared to those in the sham group (all  p  < 0.005).
CONCLUSIONS


CO 2  laser could be proposed as an effective alternative treatment for the management of GSM as it is superior to sham treatments.",2020,"In the sham group, dryness, itching, and burning were significantly improved (-1.9 [2], -1.4 [1.9], and -1 [1.9], respectively).","['postmenopausal women with genitourinary syndrome of menopause (GSM', 'genitourinary syndrome of menopause', 'Fifty-eight women (28 in the active group and 30 in the sham group) were eligible for inclusion', 'postmenopausal women diagnosed with GSM and bothersome dryness and dyspareunia']","['CO 2  laser', 'intravaginal CO 2 -laser treatment']","['proportion of participants with dryness, dyspareunia, and sexual dysfunction', 'follows: changes in Female Sexual Function Index (FSFI; total score and all domains), itching, burning, dysuria, and Urogenital Distress Inventory (UDI-6); incidence of symptoms; and presence of adverse events', 'dryness and dyspareunia intensity', 'dryness, itching, and burning', 'dryness, dyspareunia, FSFI (total score), itching, burning, dysuria, and UDI-6']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C5192371', 'cui_str': 'Genitourinary syndrome of menopause'}, {'cui': 'C1300564', 'cui_str': 'g/m2'}, {'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0013394', 'cui_str': 'Pain in female genitalia on intercourse'}]","[{'cui': 'C0392251', 'cui_str': 'Carbon dioxide laser device'}, {'cui': 'C0442122', 'cui_str': 'Intravaginal'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0013394', 'cui_str': 'Pain in female genitalia on intercourse'}, {'cui': 'C0549622', 'cui_str': 'Sexual disorder'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0278098', 'cui_str': 'Female sexual function'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0013428', 'cui_str': 'Dysuria'}, {'cui': 'C0042066', 'cui_str': 'Structure of genitourinary system'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",58.0,0.231442,"In the sham group, dryness, itching, and burning were significantly improved (-1.9 [2], -1.4 [1.9], and -1 [1.9], respectively).","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Salvatore', 'Affiliation': 'Obstetrics and Gynecology Unit, IRCCS San Raffaele Hospital, Vita-Salute San Raffaele University, Milan, Italy.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Pitsouni', 'Affiliation': ""Urogynaecology Unit, 1st Department of Obstetrics and Gynecology, 'Alexandra' Hospital, National and Kapodistrian University of Athens, Athens, Greece.""}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Grigoriadis', 'Affiliation': ""Urogynaecology Unit, 1st Department of Obstetrics and Gynecology, 'Alexandra' Hospital, National and Kapodistrian University of Athens, Athens, Greece.""}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Zacharakis', 'Affiliation': ""Urogynaecology Unit, 1st Department of Obstetrics and Gynecology, 'Alexandra' Hospital, National and Kapodistrian University of Athens, Athens, Greece.""}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Pantaleo', 'Affiliation': 'UniSR-Social.Lab, Faculty of Psychology, Vita-Salute San Raffaele University, Milan, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Candiani', 'Affiliation': 'Obstetrics and Gynecology Unit, IRCCS San Raffaele Hospital, Vita-Salute San Raffaele University, Milan, Italy.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Athanasiou', 'Affiliation': ""Urogynaecology Unit, 1st Department of Obstetrics and Gynecology, 'Alexandra' Hospital, National and Kapodistrian University of Athens, Athens, Greece.""}]",Climacteric : the journal of the International Menopause Society,['10.1080/13697137.2020.1829584']
1962,32623087,Characteristics of paradoxical tuberculosis-associated immune reconstitution inflammatory syndrome and its influence on tuberculosis treatment outcomes in persons living with HIV.,"OBJECTIVE


The influence of tuberculosis (TB)-immune reconstitution inflammatory syndrome (IRIS) on TB treatment outcomes and its risk factors were investigated among people with human immunodeficiency virus (HIV) and co-infected with TB.
METHODS


Newly diagnosed, culture-confirmed, pulmonary TB patients with HIV and enrolled in a clinical trial (NCT00933790) were retrospectively analysed for IRIS occurrence. Risk factors and TB outcomes (up to 18 months after initiation of anti-TB treatment [ATT]) were compared between people who experienced IRIS (IRIS group) and those who did not (non-IRIS group).
RESULTS


TB-IRIS occurred in 82 of 292 (28%) participants. Significant baseline risk factors predisposing to TB-IRIS occurrence in univariate analysis were: lower CD4 +  T-cell count, CD4/CD8 ratio, haemoglobin levels, presence of extra-pulmonary TB focus, and higher HIV viral load; the last two retained significance in the multivariate analysis. After 2 months of ATT commencement, sputum smear conversion was documented in 45 of 80 (56.2%) vs. 124 of 194 (63.9%) (p=0.23), culture conversion was in 75 of 80 (93.7%) vs. 178 of 194 (91.7%) (p=0.57) and the median decline in viral load (log 10 copies/mm 3 ) was 2.7 in the IRIS vs. 1.1 in the non-IRIS groups (p<0.0001), respectively. An unfavourable response to TB therapy was detected in 17 of 82 (20.7%) and 28 of 210 (13.3%) in the IRIS and non-IRIS groups, respectively (p=0.14).
CONCLUSIONS


TB-IRIS frequently occurred in people with advanced HIV infection and in those who presented with extra-pulmonary TB lesions, without influencing subsequent TB treatment outcomes.",2020,"After 2 months of ATT commencement, sputum smear conversion was documented in 45 of 80 (56.2%) vs. 124 of 194 (63.9%) (p=0.23), culture conversion was in 75 of 80 (93.7%) vs. 178 of 194 (91.7%) (p=0.57) and the median decline in viral load (log 10 copies/mm 3 ) was 2.7 in the IRIS vs. 1.1 in the non-IRIS groups (p<0.0001), respectively.","['people with human immunodeficiency virus (HIV) and co-infected with TB.\nMETHODS\n\n\nNewly diagnosed, culture-confirmed, pulmonary TB patients with HIV and enrolled in a clinical trial (NCT00933790) were retrospectively analysed for IRIS occurrence', 'persons living with HIV']",['tuberculosis (TB)-immune reconstitution inflammatory syndrome (IRIS'],"['culture conversion', 'sputum smear conversion', 'TB-IRIS', 'median decline in viral load', 'Risk factors and TB outcomes', 'lower CD4 +  T-cell count, CD4/CD8 ratio, haemoglobin levels, presence of extra-pulmonary TB focus, and higher HIV viral load']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0041327', 'cui_str': 'Pulmonary tuberculosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1619738', 'cui_str': 'Immune reconstitution inflammatory syndrome'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}]","[{'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C1619738', 'cui_str': 'Immune reconstitution inflammatory syndrome'}]","[{'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C0444186', 'cui_str': 'Smear test'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C1619738', 'cui_str': 'Immune reconstitution inflammatory syndrome'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0679362', 'cui_str': 'Tuberculosis, extrapulmonary'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1168369', 'cui_str': 'HIV viral load'}]",,0.27395,"After 2 months of ATT commencement, sputum smear conversion was documented in 45 of 80 (56.2%) vs. 124 of 194 (63.9%) (p=0.23), culture conversion was in 75 of 80 (93.7%) vs. 178 of 194 (91.7%) (p=0.57) and the median decline in viral load (log 10 copies/mm 3 ) was 2.7 in the IRIS vs. 1.1 in the non-IRIS groups (p<0.0001), respectively.","[{'ForeName': 'Gopalan', 'Initials': 'G', 'LastName': 'Narendran', 'Affiliation': 'National Institute for Research in Tuberculosis, Indian Council of Medical Research Chennai, Tamil Nadu, India.'}, {'ForeName': 'Keerthana', 'Initials': 'K', 'LastName': 'Jyotheeswaran', 'Affiliation': 'National Institute for Research in Tuberculosis, Indian Council of Medical Research Chennai, Tamil Nadu, India.'}, {'ForeName': 'Thirumaran', 'Initials': 'T', 'LastName': 'Senguttuvan', 'Affiliation': 'National Institute for Research in Tuberculosis, Indian Council of Medical Research Chennai, Tamil Nadu, India.'}, {'ForeName': 'Caian L', 'Initials': 'CL', 'LastName': 'Vinhaes', 'Affiliation': 'Instituto Gonçalo Moniz, Fundação Oswaldo Cruz, Salvador, Brazil; Multinational Organization Network Sponsoring Translational and Epidemiological Research (MONSTER) Initiative, Salvador, Brazil; Curso de Medicina, Faculdade de Tecnologia e Ciências (UniFTC), Salvador, Brazil.'}, {'ForeName': 'Ramesh K', 'Initials': 'RK', 'LastName': 'Santhanakrishnan', 'Affiliation': 'National Institute for Research in Tuberculosis, Indian Council of Medical Research Chennai, Tamil Nadu, India.'}, {'ForeName': 'Tamizhselvan', 'Initials': 'T', 'LastName': 'Manoharan', 'Affiliation': 'National Institute for Research in Tuberculosis, Indian Council of Medical Research Chennai, Tamil Nadu, India.'}, {'ForeName': 'Anbhalagan', 'Initials': 'A', 'LastName': 'Selvaraj', 'Affiliation': 'National Institute for Research in Tuberculosis, Indian Council of Medical Research Chennai, Tamil Nadu, India.'}, {'ForeName': 'Padmapriyadarsini', 'Initials': 'P', 'LastName': 'Chandrasekaran', 'Affiliation': 'National Institute for Research in Tuberculosis, Indian Council of Medical Research Chennai, Tamil Nadu, India.'}, {'ForeName': 'Pradeep A', 'Initials': 'PA', 'LastName': 'Menon', 'Affiliation': 'National Institute for Research in Tuberculosis, Indian Council of Medical Research Chennai, Tamil Nadu, India.'}, {'ForeName': 'Kannabiran P', 'Initials': 'KP', 'LastName': 'Bhavani', 'Affiliation': 'National Institute for Research in Tuberculosis, Indian Council of Medical Research Chennai, Tamil Nadu, India.'}, {'ForeName': 'Devarajulu', 'Initials': 'D', 'LastName': 'Reddy', 'Affiliation': 'National Institute for Research in Tuberculosis, Indian Council of Medical Research Chennai, Tamil Nadu, India.'}, {'ForeName': 'Ravichandran', 'Initials': 'R', 'LastName': 'Narayanan', 'Affiliation': 'Government Hospital of Thoracic Medicine, Tambaram Sanatorium, Chennai, Tamil Nadu, India.'}, {'ForeName': 'Balaji', 'Initials': 'B', 'LastName': 'Subramanyam', 'Affiliation': 'National Institute for Research in Tuberculosis, Indian Council of Medical Research Chennai, Tamil Nadu, India.'}, {'ForeName': 'Sekhar', 'Initials': 'S', 'LastName': 'Sathyavelu', 'Affiliation': 'Rajiv Gandhi Government General Hospital, Park Town, Chennai, Tamil Nadu, India.'}, {'ForeName': 'Raja', 'Initials': 'R', 'LastName': 'Krishnaraja', 'Affiliation': 'Government Hospital of Thoracic Medicine, Tambaram Sanatorium, Chennai, Tamil Nadu, India.'}, {'ForeName': 'Pownraj', 'Initials': 'P', 'LastName': 'Kalirajan', 'Affiliation': 'National Institute for Research in Tuberculosis, Indian Council of Medical Research Chennai, Tamil Nadu, India.'}, {'ForeName': 'Dhanalakshmi', 'Initials': 'D', 'LastName': 'Angamuthu', 'Affiliation': 'National Institute for Research in Tuberculosis, Indian Council of Medical Research Chennai, Tamil Nadu, India.'}, {'ForeName': 'Stella Mary', 'Initials': 'SM', 'LastName': 'Susaimuthu', 'Affiliation': 'National Institute for Research in Tuberculosis, Indian Council of Medical Research Chennai, Tamil Nadu, India.'}, {'ForeName': 'Ranjit R K', 'Initials': 'RRK', 'LastName': 'Ganesan', 'Affiliation': 'Government Rajaji Hospital, Madurai, Tamil Nadu, India.'}, {'ForeName': 'Srikanth P', 'Initials': 'SP', 'LastName': 'Tripathy', 'Affiliation': 'National Institute for Research in Tuberculosis, Indian Council of Medical Research Chennai, Tamil Nadu, India.'}, {'ForeName': 'Soumya', 'Initials': 'S', 'LastName': 'Swaminathan', 'Affiliation': 'World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Bruno B', 'Initials': 'BB', 'LastName': 'Andrade', 'Affiliation': 'Instituto Gonçalo Moniz, Fundação Oswaldo Cruz, Salvador, Brazil; Multinational Organization Network Sponsoring Translational and Epidemiological Research (MONSTER) Initiative, Salvador, Brazil; Curso de Medicina, Faculdade de Tecnologia e Ciências (UniFTC), Salvador, Brazil; Universidade Salvador (UNIFACS), Laureate Universities, Salvador, Brazil; Escola Bahiana de Medicina e Saúde Pública (EBMSP), Salvador, Brazil; Wellcome Centre for Infectious Disease Research in Africa, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa. Electronic address: bruno.andrade@fiocruz.br.'}]",International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases,['10.1016/j.ijid.2020.06.097']
1963,32705504,Valsartan Versus Amlodipine Effect on Left Ventricular Multidirectional Deformation and Adipocytokines Levels in Hypertensive Patients: Speckle Tracking Echocardiography.,"INTRODUCTION


Structural and functional properties of the left ventricle (LV) wall have been reported to be altered in hypertension, even at early stages of the disease. Abnormal adipokine levels affect blood pressure regulation. Hypo-adiponectinaemia and hyper-leptinaemia were reported in hypertension.
AIM


To evaluate the effects of valsartan versus amlodipine on LV deformation also, on plasma adiponectin and leptin levels in hypertensive individuals.
METHODS


LV strain was measured by two-dimensional speckle tracking echocardiography, plasma levels of adiponectin and leptin was determined in 30 healthy individuals served as control group and in 200 hypertensive patients before and after treatment for 6 months with either valsartan 160 mg or amlodipine 10 mg.
RESULTS


Compared to control group longitudinal strain was significantly affected in hypertensive patients, adiponectin was significantly lower while TNF-α, hs-CRP and leptin levels were significantly higher in hypertensive group. A significant improvement in LV functions, along with a decrease in leptin and increase in adiponectin levels in valsartan group compared to amlodipine group.
CONCLUSIONS


Our results indicate that valsartan is superior to amlodipine when it comes to affecting the hormonal function of human adipose tissue. Valsartan has a beneficial effect on LV deformation and function presented in GLS.",2020,"Compared to control group longitudinal strain was significantly affected in hypertensive patients, adiponectin was significantly lower while TNF-α, hs-CRP and leptin levels were significantly higher in hypertensive group.","['hypertensive individuals', '30 healthy individuals served as control group and in 200 hypertensive patients before and after treatment for 6 months with either', 'Hypertensive Patients']","['Valsartan', 'valsartan', 'valsartan 160\xa0mg or amlodipine 10\xa0mg', 'amlodipine', 'Valsartan Versus Amlodipine', 'valsartan versus amlodipine']","['adiponectin levels', 'Left Ventricular Multidirectional Deformation and Adipocytokines Levels', 'LV functions', 'Abnormal adipokine levels affect blood pressure regulation', 'Hypo-adiponectinaemia and hyper-leptinaemia', 'leptin', 'hypertensive patients, adiponectin', 'plasma adiponectin and leptin levels', 'TNF-α, hs-CRP and leptin levels']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0216784', 'cui_str': 'valsartan'}, {'cui': 'C0991106', 'cui_str': 'valsartan 160 MG'}, {'cui': 'C1124794', 'cui_str': 'Amlodipine 10 MG'}, {'cui': 'C0051696', 'cui_str': 'Amlodipine'}]","[{'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0007799', 'cui_str': 'Brain ventricle structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C1955907', 'cui_str': 'Adipokine'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}]",200.0,0.0121217,"Compared to control group longitudinal strain was significantly affected in hypertensive patients, adiponectin was significantly lower while TNF-α, hs-CRP and leptin levels were significantly higher in hypertensive group.","[{'ForeName': 'Ibtsam', 'Initials': 'I', 'LastName': 'Khairat', 'Affiliation': 'Department of Cardiology, Faculty of Medicine, Tanta University, El-Gharbia, Egypt.'}, {'ForeName': 'Lamiaa', 'Initials': 'L', 'LastName': 'Khedr', 'Affiliation': 'Department of Cardiology, Faculty of Medicine, Tanta University, El-Gharbia, Egypt.'}, {'ForeName': 'Rehab', 'Initials': 'R', 'LastName': 'Werida', 'Affiliation': 'Department of Clinical Pharmacy, Faculty of Pharmacy, Damanhour University, El-Behaira, 22511, Egypt. rehabwrieda@pharm.dmu.edu.eg.'}]",High blood pressure & cardiovascular prevention : the official journal of the Italian Society of Hypertension,['10.1007/s40292-020-00398-7']
1964,33090016,Fast acting insulin aspart Compared to Insulin aspart in the Medtronic 670G Hybrid Closed Loop System in Type 1 Diabetes: An Open Label Crossover Study.,"This is a single-center, randomized, open label, active-controlled, cross-over trial comparing efficacy and safety of faster insulin aspart (FIASP®) (FA) versus insulin aspart (NovoLog®) (IAsp) when used in the Medtronic 670G system in Auto Mode in patients with type 1 diabetes. 40 patients were randomized to either IAsp or FA. Each treatment period was 7 weeks and a standardized meal test was administered 6 weeks after the start of each treatment period. The primary endpoint was PPG increment after the meal test at 1 hour. Treatment with FA using the MiniMed 670G HCL led to a greater reduction in one-hour post-prandial glucose increase compared to treatment with IAsp during the standardized mixed meal test. Change in glucose: [Estimated treatment difference (ETD±SD); 95% CI]: 70.27 (±17.36) mg/dl (3.9 ± 1.0 mmol/l) with FA vs. 98.42 (±17.36) mg/dl (5.5 ± 1.0 mmol/l) with IAsp (p=0.008). Patients spent 1.81% (p=0.016) more time (equivalent to 26 minutes per day) in the 70-180 mg/dl (3.89-9.99 mmol/l) range with FA than with IAsp. The entire sample spent only 0.5% of time <54 mg/dL (<3.0 mmol/l) range. The increment in the one hour post meal test glucose was significantly lower with FA vs IAsp. FA in a HCL setting is safe and effective with patients spending more time in the 70-180 mg/dl (3.89-9.99 mmol/l) target range than with IAsp. Key Words: Fast acting insulin aspart, Medtronic 670G hybrid closed loop, Type 1 Diabetes.",2020,Patients spent 1.81% (p=0.016) more time (equivalent to 26 minutes per day) in the 70-180 mg/dl (3.89-9.99 mmol/l) range with FA than with IAsp.,"['Type 1 Diabetes', 'patients with type 1 diabetes', '40 patients']","['Fast acting insulin aspart, Medtronic 670G hybrid closed loop, Type 1 Diabetes', 'IAsp or FA', 'faster insulin aspart (FIASP®) (FA) versus insulin aspart (NovoLog®) (IAsp', 'Insulin aspart', 'Medtronic 670G Hybrid Closed Loop System', 'Fast acting insulin aspart']","['PPG increment', 'Change in glucose']","[{'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0123677', 'cui_str': 'Insulin, Aspart, Human'}, {'cui': 'C4517853', 'cui_str': '670'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0445022', 'cui_str': 'Loop'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0939412', 'cui_str': 'NovoRapid'}, {'cui': 'C4529885', 'cui_str': 'Fiasp'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0049716', 'cui_str': ""6-thioguanosine 5'-diphosphate""}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}]",40.0,0.0308333,Patients spent 1.81% (p=0.016) more time (equivalent to 26 minutes per day) in the 70-180 mg/dl (3.89-9.99 mmol/l) range with FA than with IAsp.,"[{'ForeName': 'Kerem', 'Initials': 'K', 'LastName': 'Ozer', 'Affiliation': 'Texas Diabetes & Endocrinology, Austin, Texas, United States; kerem.ozer@texasdiabetes.com.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Cooper', 'Affiliation': 'Texas Diabetes & Endocrinology, 6500 N Mopac Expwy, Austin, Texas, United States, 78731; acooper@texasdiabetes.com.'}, {'ForeName': 'Lily', 'Initials': 'L', 'LastName': 'Ahn', 'Affiliation': 'Texas Diabetes & Endocrinology, 6500 N Mopac Expwy, Austin, Texas, United States, 78731; lahn@texasdiabetes.com.'}, {'ForeName': 'Cassidy', 'Initials': 'C', 'LastName': 'Waggonner', 'Affiliation': 'Texas Diabetes & Endocrinology, 6500 N Mopac Expwy, Bldg 3, Suite 200, Austin, Texas, United States, 78731; cwaggonner@texasdiabetes.com.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Blevins', 'Affiliation': 'Texas Diabetes & Endocrinology, 6500 N Mopac Expwy, Bldg 3, Suite 200, Austin, TX 78731, Austin, Texas, United States, 78731; blevins@texasdiabetes.com.'}]",Diabetes technology & therapeutics,['10.1089/dia.2020.0500']
1965,33090083,The Effect of Different Interventions for Lifestyle Modifications on the Number of Diagnostic Criteria and Clinical Aspects of Metabolic Syndrome.,"Background:  Lifestyle intervention programs comprise the first-choice therapy to reduce the cardiovascular risk factors in metabolic syndrome (MetS). Our aim was to compare the effects of three lifestyle modification programs on the number of diagnostic criteria and clinical parameters of MetS.  Methods:  Twelve-week clinical trial, including 125 adults who presented at least three of the criteria defined by the revised NCEP ATP III (National Cholesterol Education Program Adult Panel III) for MetS. Individuals were randomized into three multidisciplinary intervention groups: Standard Intervention (SI), Group Intervention (GI) and Individual Intervention (II).  Results:  Seventy-one individuals, aged 34-59 years, concluded the study: SI: 20, GI: 25, and II: 26. The GI and II groups presented a significant decrease of body mass index, abdominal circumference, diastolic and systolic arterial pressure after intervention. The number of diagnostic criteria for MetS decreased significantly. Within the GI and II groups, 16.0% and 15.4% of the individuals, respectively, did not meet the criteria for the clinical condition studied at the end of the interventions. In the II group, the percentage of individuals with five criteria reduced 83.5%. In the GI group, the percentage of individuals with five criteria remained the same, but the number of individuals with four criteria presented a 50.0% reduction.  Conclusions:  Results reinforce that nonpharmacological strategies for changing lifestyle affect the reduction of cardiovascular risk factors existing in MetS. They are also able to remove the population from this clinical condition by decreasing the diagnostic criteria. II or GI lead to a successful treatment of MetS, especially when conducted by multidisciplinary team. Brazilian Registry of Clinical Trials-ReBEC number: RBR-9wz5fc.",2020,"The GI and II groups presented a significant decrease of body mass index, abdominal circumference, diastolic and systolic arterial pressure after intervention.","['Seventy-one individuals, aged 34-59 years, concluded the study: SI: 20, GI: 25, and II: 26', 'metabolic syndrome (MetS', '125 adults who presented at least three of the criteria defined by the revised NCEP ATP III (National Cholesterol Education Program Adult Panel III) for MetS. Individuals']","['three lifestyle modification programs', 'multidisciplinary intervention groups: Standard Intervention (SI), Group Intervention (GI) and Individual Intervention (II']","['body mass index, abdominal circumference, diastolic and systolic arterial pressure', 'number of diagnostic criteria for MetS']","[{'cui': 'C0450389', 'cui_str': '71'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0917903', 'cui_str': 'Conclude Composite Resin'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0001480', 'cui_str': 'Adenosine Triphosphate'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0441833', 'cui_str': 'Groups'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1300813', 'cui_str': 'Abdominal circumference'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]",125.0,0.0223489,"The GI and II groups presented a significant decrease of body mass index, abdominal circumference, diastolic and systolic arterial pressure after intervention.","[{'ForeName': 'Carla Haas', 'Initials': 'CH', 'LastName': 'Piovesan', 'Affiliation': 'School of Health and Life Sciences, Pontifical Catholic University of Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Andréia', 'Initials': 'A', 'LastName': 'Gustavo', 'Affiliation': 'School of Health and Life Sciences, Pontifical Catholic University of Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Fabrício Edler', 'Initials': 'FE', 'LastName': 'Macagnan', 'Affiliation': 'Department of Physiotherapy, Federal University of Health Sciences of Porto Alegre, Porto Alegre, Brazil.'}, {'ForeName': 'Patricia Pozas', 'Initials': 'PP', 'LastName': 'Saboya', 'Affiliation': 'Cardiology Service of Hospital São Lucas, Faculty of Medicine, Pontifical Catholic University of Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Margareth da Silva', 'Initials': 'MDS', 'LastName': 'Oliveira', 'Affiliation': 'School of Health and Life Sciences, Pontifical Catholic University of Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Luiz Carlos', 'Initials': 'LC', 'LastName': 'Bodanese', 'Affiliation': 'Cardiology Service of Hospital São Lucas, Faculty of Medicine, Pontifical Catholic University of Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Martha Wallig Brusius', 'Initials': 'MWB', 'LastName': 'Ludwig', 'Affiliation': 'Department of Contextual Behavioral Therapies, Center for Family and Individual Studies, Porto Alegre, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Vera Elizabeth', 'Initials': 'VE', 'LastName': 'Closs', 'Affiliation': 'Biomedical Gerontology Graduate Program - Study Group on Cardiometabolic Risk, Aging and Nutrition - Institute of Geriatrics and Gerontology, Pontifical Catholic University of Rio Grande do Sul, Porto Alegre RS, Brazil.'}, {'ForeName': 'Ana Maria Pandolfo', 'Initials': 'AMP', 'LastName': 'Feoli', 'Affiliation': 'School of Health and Life Sciences, Pontifical Catholic University of Rio Grande do Sul, Porto Alegre, Brazil.'}]",Metabolic syndrome and related disorders,['10.1089/met.2019.0132']
1966,33090213,The effect of individual counseling intervention on health practices in pregnancy: a randomized controlled trial.,"This research was carried out to determine the effect of individual counseling intervention on health practices in pregnancy. This research is a single-blind randomized controlled experimental and follow-up design. Population of the research consisted of 126 pregnant women in total, with 64 of them being in the training group and 64 being in the control group. The research data were collected by using a 'Pregnant Identifying Information Form' and 'Health Practices in Pregnancy Questionnaire (HPQ)'. In this research, it was found that there was no significant difference in total score average of the HPQ before the individual counseling training between the pregnant women in the training and control groups (P > 0.05). It was also determined that there was a statistically significant difference in total score average of the HPQ after the individual counseling training during the second trimester between the two groups (P < 0.05). It was determined that there was a statistically significant difference in total score average of the HPQ during the third trimester between two groups (P < 0.05). It has been determined that the training provided with individual counseling to pregnant women is an effective initiative in increasing the health practices of pregnant women.",2020,It was also determined that there was a statistically significant difference in total score average of the HPQ after the individual counseling training during the second trimester between the two groups (P < 0.05).,"['pregnant women', 'health practices in pregnancy', '126 pregnant women in total, with 64 of them being in the training group and 64 being in the control group']",['individual counseling intervention'],['total score average of the HPQ'],"[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",126.0,0.0190173,It was also determined that there was a statistically significant difference in total score average of the HPQ after the individual counseling training during the second trimester between the two groups (P < 0.05).,"[{'ForeName': 'Gozde', 'Initials': 'G', 'LastName': 'Sezer', 'Affiliation': 'Health Science Institute, Celal Bayar University, Yunusemre, Manısa, Turkey.'}, {'ForeName': 'Selma', 'Initials': 'S', 'LastName': 'Sen', 'Affiliation': 'Midwifery Department, Faculty of Sciences, Celal Bayar University, Yunusemre, Manısa, Turkey.'}]",Health education research,['10.1093/her/cyaa025']
1967,32881968,Adjuvanted HIV-1 vaccine promotes antibody-dependent phagocytic responses and protects against heterologous SHIV challenge.,"To augment HIV-1 pox-protein vaccine immunogenicity using a next generation adjuvant, a prime-boost strategy of recombinant modified vaccinia virus Ankara and multimeric Env gp145 was evaluated in macaques with either aluminum (alum) or a novel liposomal monophosphoryl lipid A (MPLA) formulation adsorbed to alum, ALFA. Binding antibody responses were robust and comparable between arms, while antibody-dependent neutrophil and monocyte phagocytotic responses were greatly enhanced by ALFA. Per-exposure vaccine efficacy against heterologous tier 2 SHIV mucosal challenge was 90% in ALFA-adjuvanted males (P = 0.002), while alum conferred no protection. Half of the ALFA-adjuvanted males remained uninfected after the full challenge series, which spanned seven months after the last vaccination. Antibody-dependent monocyte and neutrophil phagocytic responses both strongly correlated with protection. Significant sex differences in infection risk were observed, with much lower infection rates in females than males. In humans, MPLA-liposome-alum adjuvanted gp120 also increased HIV-1-specific phagocytic responses relative to alum. Thus, next-generation liposome-based adjuvants can drive vaccine elicited antibody effector activity towards potent phagocytic responses in both macaques and humans and these responses correlate with protection. Future protein vaccination strategies aiming to improve functional humoral responses may benefit from such adjuvants.",2020,"Per-exposure vaccine efficacy against heterologous tier 2 SHIV mucosal challenge was 90% in ALFA-adjuvanted males (P = 0.002), while alum conferred no protection.",['macaques with either aluminum (alum) or a'],"['novel liposomal monophosphoryl lipid A (MPLA) formulation adsorbed to alum, ALFA']","['HIV-1-specific phagocytic responses', 'SHIV mucosal challenge', 'infection risk', 'Binding antibody responses', 'neutrophil and monocyte phagocytotic responses', 'infection rates']","[{'cui': 'C0024398', 'cui_str': 'Genus Macaca'}, {'cui': 'C0002367', 'cui_str': 'Aluminum'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0023828', 'cui_str': 'Liposomes'}, {'cui': 'C0066776', 'cui_str': 'monophosphoryl lipid A'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0002367', 'cui_str': 'Aluminum'}]","[{'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0582147', 'cui_str': 'At risk for infection'}, {'cui': 'C0332297', 'cui_str': 'Bounded by'}, {'cui': 'C0003261', 'cui_str': 'Antibody Production'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0026473', 'cui_str': 'Monocyte'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]",,0.0287061,"Per-exposure vaccine efficacy against heterologous tier 2 SHIV mucosal challenge was 90% in ALFA-adjuvanted males (P = 0.002), while alum conferred no protection.","[{'ForeName': 'Kier', 'Initials': 'K', 'LastName': 'Om', 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, Maryland, United States of America.'}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'Paquin-Proulx', 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, Maryland, United States of America.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Montero', 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, Maryland, United States of America.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Peachman', 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, Maryland, United States of America.'}, {'ForeName': 'Xiaoying', 'Initials': 'X', 'LastName': 'Shen', 'Affiliation': 'Duke Human Vaccine Institute, Duke University School of Medicine, Durham, North Carolina, United States of America.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Wieczorek', 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, Maryland, United States of America.'}, {'ForeName': 'Zoltan', 'Initials': 'Z', 'LastName': 'Beck', 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, Maryland, United States of America.'}, {'ForeName': 'Joshua A', 'Initials': 'JA', 'LastName': 'Weiner', 'Affiliation': 'Thayer School of Engineering, Dartmouth College, Hanover, New Hampshire, United States of America.'}, {'ForeName': 'Dohoon', 'Initials': 'D', 'LastName': 'Kim', 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, Maryland, United States of America.'}, {'ForeName': 'Yifan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, Maryland, United States of America.'}, {'ForeName': 'Thembi', 'Initials': 'T', 'LastName': 'Mdluli', 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, Maryland, United States of America.'}, {'ForeName': 'Zhanna', 'Initials': 'Z', 'LastName': 'Shubin', 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, Maryland, United States of America.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Bryant', 'Affiliation': 'EMMES, Rockville, Maryland, United States of America.'}, {'ForeName': 'Vishakha', 'Initials': 'V', 'LastName': 'Sharma', 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, Maryland, United States of America.'}, {'ForeName': 'Andrey', 'Initials': 'A', 'LastName': 'Tokarev', 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, Maryland, United States of America.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Dawson', 'Affiliation': 'EMMES, Rockville, Maryland, United States of America.'}, {'ForeName': 'Yohann', 'Initials': 'Y', 'LastName': 'White', 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, Maryland, United States of America.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Appelbe', 'Affiliation': 'Department of Pharmaceutics, University of Washington, Seattle, Washington, United States of America.'}, {'ForeName': 'Nichole R', 'Initials': 'NR', 'LastName': 'Klatt', 'Affiliation': 'Department of Pharmaceutics, University of Washington, Seattle, Washington, United States of America.'}, {'ForeName': 'Sodsai', 'Initials': 'S', 'LastName': 'Tovanabutra', 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, Maryland, United States of America.'}, {'ForeName': 'Jacob D', 'Initials': 'JD', 'LastName': 'Estes', 'Affiliation': 'AIDS and Cancer Virus Program, Frederick National Laboratory for Cancer Research, Leidos Biomedical Research, Inc., Frederick, Maryland, United States of America.'}, {'ForeName': 'Gary R', 'Initials': 'GR', 'LastName': 'Matyas', 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, Maryland, United States of America.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Ferrari', 'Affiliation': 'Duke Human Vaccine Institute, Duke University School of Medicine, Durham, North Carolina, United States of America.'}, {'ForeName': 'Carl R', 'Initials': 'CR', 'LastName': 'Alving', 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, Maryland, United States of America.'}, {'ForeName': 'Georgia D', 'Initials': 'GD', 'LastName': 'Tomaras', 'Affiliation': 'Duke Human Vaccine Institute, Duke University School of Medicine, Durham, North Carolina, United States of America.'}, {'ForeName': 'Margaret E', 'Initials': 'ME', 'LastName': 'Ackerman', 'Affiliation': 'Thayer School of Engineering, Dartmouth College, Hanover, New Hampshire, United States of America.'}, {'ForeName': 'Nelson L', 'Initials': 'NL', 'LastName': 'Michael', 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, Maryland, United States of America.'}, {'ForeName': 'Merlin L', 'Initials': 'ML', 'LastName': 'Robb', 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, Maryland, United States of America.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Polonis', 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, Maryland, United States of America.'}, {'ForeName': 'Morgane', 'Initials': 'M', 'LastName': 'Rolland', 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, Maryland, United States of America.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Eller', 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, Maryland, United States of America.'}, {'ForeName': 'Mangala', 'Initials': 'M', 'LastName': 'Rao', 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, Maryland, United States of America.'}, {'ForeName': 'Diane L', 'Initials': 'DL', 'LastName': 'Bolton', 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, Maryland, United States of America.'}]",PLoS pathogens,['10.1371/journal.ppat.1008764']
1968,32162530,Development and Validation of a Risk Score for Prediction of Venous Thromboembolism in Patients With Lung Cancer.,"This study aimed to develop and validate a risk score for early prediction of venous thromboembolism (VTE) in patients with lung cancer. A total of 827 patients with lung cancer from February 2013 to February 2018 in our hospital were retrospectively analyzed. Demographic and clinicopathological variables independently correlated to VTE were applied to develop the risk score in the development group while examined in the validation group. The regression coefficients of multivariable logistic regression test were applied to assign a risk score system. The incidence of VTE was 12.3%, 12.7%, and 11.8% in all patients, in the development and validation groups, respectively. The 496 patients in the development group were classified into 3 groups: low risk (scores ≤3), moderate risk (scores 4-5), and high risk (scores ≥6). The risk of VTE was significantly and positively related to the risk scores in both development and validation groups. The risk score system aided proper stratification of patients with either high or low risk of VTE in the development and validation groups ( c  statistic = 0.819 and 0.827, respectively). This risk score system based on the factors with most significant correlation showed good predictive ability and is potentially useful for predicting VTE in patients with lung cancer. However, it was developed and validated by a retrospective analysis and has significant limitations, and a prospective validation with all the classic variables assessing the thrombotic risk is needed for a solid conclusion.",2020,This risk score system based on the factors with most significant correlation showed good predictive ability and is potentially useful for predicting VTE in patients with lung cancer.,"['827 patients with lung cancer from February 2013 to February 2018 in our hospital were retrospectively analyzed', 'patients with lung cancer', '496 patients in the development group were classified into 3 groups: low risk (scores ≤3), moderate risk (scores 4-5), and high risk (scores ≥6', 'Patients With Lung Cancer']",[],"['risk of VTE', 'incidence of VTE']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}]",[],"[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",827.0,0.0141398,This risk score system based on the factors with most significant correlation showed good predictive ability and is potentially useful for predicting VTE in patients with lung cancer.,"[{'ForeName': 'Zilun', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Division of Vascular Surgery, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Guolong', 'Initials': 'G', 'LastName': 'Zhang', 'Affiliation': 'Guangzhou Institute of Respiratory Disease, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Mengping', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Mei', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Huiwen', 'Initials': 'H', 'LastName': 'Weng', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Zhenwei', 'Initials': 'Z', 'LastName': 'Peng', 'Affiliation': 'Department of Radiation Oncology, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}]",Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis,['10.1177/1076029620910793']
1969,32492734,Hemodynamic and Pressor Responses to Combination of Yoga and Blood Flow Restriction.,"A combination of yoga and blood flow restriction, each of which elicits marked pressor responses, may further increase blood pressure and myocardial oxygen demand. To determine the impact of a combination of yoga and blood flow restriction on hemodynamic responses, twenty young healthy participants performed 20 yoga poses with/without blood flow restriction bands placed on both legs. At baseline, there were no significant differences in any of the variables between the blood flow restriction and non-blood flow restriction conditions. Blood pressure and heart rate increased in response to the various yoga poses (p<0.01) but were not different between the blood flow restriction and non-blood flow restriction conditions. Rate-pressure products, an index of myocardial oxygen demand, increased significantly during yoga exercises with no significant differences between the two conditions. Rating of perceived exertion was not different between the conditions. Blood lactate concentration was significantly greater after performing yoga with blood flow restriction bands (p=0.007). Cardio-ankle vascular index, an index of arterial stiffness, decreased similarly after yoga exercise in both conditions while flow-mediated dilation remained unchanged. In conclusion, the use of lower body blood flow restriction bands in combination with yoga did not result in additive or synergistic hemodynamic and pressor responses.",2020,Blood lactate concentration was significantly greater after performing yoga with blood flow restriction bands (p=0.007).,['twenty young healthy participants performed 20 yoga poses with/without blood flow restriction bands placed on both legs'],"['yoga and blood flow restriction', 'Yoga and Blood Flow Restriction']","['blood flow restriction and non-blood flow restriction conditions', 'blood pressure and myocardial oxygen demand', 'Rating of perceived exertion', 'Cardio-ankle vascular index, an index of arterial stiffness', 'Blood pressure and heart rate', 'Rate-pressure products, an index of myocardial oxygen demand', 'additive or synergistic hemodynamic and pressor responses', 'Blood lactate concentration', 'Hemodynamic and Pressor Responses']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0230446', 'cui_str': 'Both lower legs'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}]","[{'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C4034558', 'cui_str': 'Cardio-ankle vascular index'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0442796', 'cui_str': 'Additive'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",20.0,0.0223985,Blood lactate concentration was significantly greater after performing yoga with blood flow restriction bands (p=0.007).,"[{'ForeName': 'Savannah V', 'Initials': 'SV', 'LastName': 'Wooten', 'Affiliation': 'Kinesiology and Health Education, The University of Texas at Austin, Austin, Texas, United States.'}, {'ForeName': 'Sten', 'Initials': 'S', 'LastName': 'Stray-Gundersen', 'Affiliation': 'Kinesiology and Health Education, The University of Texas at Austin, Austin, Texas, United States.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Tanaka', 'Affiliation': 'Kinesiology and Health Education, The University of Texas at Austin, Austin, Texas, United States.'}]",International journal of sports medicine,['10.1055/a-1171-1620']
1970,32505198,The relationship between depression risk perception and self-help behaviours in high risk Canadians: a cross-sectional study.,"BACKGROUND


Self-help may reduce the risk of depression, and risk perception of depression may influence initiating self-help. It is unknown how risk perception is associated with self-help behaviours. The objectives of this study are to (1) describe the self-help strategies used by high-risk Canadians in relation to the accuracy of perceived depression risk, by sex, and (2) identify demographic and clinical factors associated with self-help behaviours.
METHODS


Baseline data from a randomized controlled trial including 358 men and 356 women at high-risk of developing depression were used. Following methods used in cancer research, risk perception accuracy was determined by comparing the participant's self-perceived and objective risk of developing depression and classifying as accurate, over-estimation and under-estimation based on a ± 10% threshold. The participant's objective depression risk was assessed using sex-specific multivariable risk predictive algorithms. Frequency of using 14 self-help strategies was assessed. One-way ANOVA testing was used to detect if differences in risk perception accuracy groups existed, stratified by sex. Linear regression was used to investigate the clinical and demographic factors associated with self-help behaviours, also stratified.
RESULTS


Compared to accurate-estimators, male over-estimators were less likely to ""leave the house daily,"" and ""participate in activities they enjoy."" Male under-estimators were also less likely to ""participate in activities they enjoy."" Both male 'inaccurate' perception groups were more likely to 'create lists of strategies which have worked for feelings of depression in the past and use them'. There were no significant differences between self-help behaviours and risk perception accuracy in women. Regression modeling showed negative relationships between self-rated health and self-help scores, irrespective of sex. In women, self-help score was positively associated with age and educational attainment, and negatively associated with perceived risk. In men, a positive relationship with unemployment was also seen.
CONCLUSIONS


Sex differences exist in the factors associated with self-help. Risk perception accuracy, work status, and self-rated health is associated with self-help behaviours in high-risk men. In women, factors related to self-help included age, education, self-rated health status, and perceived risk. More research is needed to replicate findings.
TRIAL REGISTRATION


Prospectively registered at ClinicalTrials.gov (NCT02943876) as of 10/21/16.",2020,Both male 'inaccurate' perception groups were more likely to 'create lists of strategies which have worked for feelings of depression in the past and use them'.,"['high risk Canadians', 'high-risk men', '358 men and 356 women at high-risk of developing depression were used']",[],"['Risk perception accuracy, work status, and self-rated health', 'depression risk perception and self-help behaviours', 'self-help behaviours and risk perception accuracy']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",[],"[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",358.0,0.0362948,Both male 'inaccurate' perception groups were more likely to 'create lists of strategies which have worked for feelings of depression in the past and use them'.,"[{'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Warner', 'Affiliation': 'The Institute of Mental Health Research, University of Ottawa, Ottawa, Canada.'}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Nannarone', 'Affiliation': 'The Institute of Mental Health Research, University of Ottawa, Ottawa, Canada.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Smail-Crevier', 'Affiliation': 'The Institute of Mental Health Research, University of Ottawa, Ottawa, Canada.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Manuel', 'Affiliation': 'School of Epidemiology and Public Health, Faculty of Medicine, University of Ottawa, Ottawa, Canada.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Lashewicz', 'Affiliation': 'Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Canada.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Patten', 'Affiliation': 'Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Canada.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Schmitz', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine, McGill University, Montreal, Canada.'}, {'ForeName': 'Glenda', 'Initials': 'G', 'LastName': 'MacQueen', 'Affiliation': 'Department of Psychiatry, Cumming School of Medicine, University of Calgary, Calgary, Canada.'}, {'ForeName': 'Jian Li', 'Initials': 'JL', 'LastName': 'Wang', 'Affiliation': 'The Institute of Mental Health Research, University of Ottawa, Ottawa, Canada. JianLi.Wang@theroyal.ca.'}]",BMC public health,['10.1186/s12889-020-08983-0']
1971,30267864,Combination Therapy With Infliximab and Azathioprine Improves Infliximab Pharmacokinetic Features and Efficacy: A Post Hoc Analysis.,"BACKGROUND & AIMS


Among immunosuppressive- and biologic-naïve patients with moderately-to-severely active Crohn's disease (CD), a higher proportion of those treated with the combination of infliximab and azathioprine achieved corticosteroid-free remission at week 26 (CSFR26) than those given infliximab monotherapy; patients given the combination therapy also had higher serum concentrations of infliximab. Enhanced benefit of combination therapy may occur through synergistic modes of action or the influence of azathioprine on infliximab pharmacokinetics.
METHODS


We analyzed data from 206 patients from whom week 30 serum samples were available: 97 received infliximab monotherapy (5 mg/kg, n = 97) and 109 received combination therapy (2.5 mg/kg/day; n = 109). Proportions of patients achieving CSFR26 and mucosal healing (absence of ulcers) at week 26 were calculated for each quartile of serum concentrations of infliximab, and exposure-response relationships were compared.
RESULTS


Within quartiles of serum concentrations of infliximab, CSFR26 did not differ significantly between patients who received combination therapy vs monotherapy. However, among patients in the lowest quartile of serum concentration of infliximab, twice as many patients who received infliximab monotherapy achieved CSFR26 vs combination therapy. Anti-drug antibodies were detected only in the lowest quartile of serum concentrations of infliximab-in 35.9% of patients given monotherapy and 8.3% of patients given combination therapy.
CONCLUSION


Among patients with CD and similar serum concentrations of infliximab, combination therapy with azathioprine was not significantly more effective than infliximab monotherapy. Combination therapy with azathioprine appears to improve efficacy by increasing pharmacokinetic features of infliximab. ClinicalTrials.gov, NCT00094458.",2019,"Within quartiles of serum concentrations of infliximab, CSFR26 did not differ significantly between patients who received combination therapy vs monotherapy.","[""immunosuppressive- and biologic-naïve patients with moderately-to-severely active Crohn's disease (CD"", '206 patients from whom week 30 serum samples were available: 97\xa0received']","['combination therapy', 'Infliximab and Azathioprine', 'combination therapy vs monotherapy', 'infliximab', 'infliximab monotherapy', 'infliximab and azathioprine', 'azathioprine']","['CSFR26 and mucosal healing (absence of ulcers', 'Infliximab Pharmacokinetic Features and Efficacy', 'serum concentrations of infliximab, CSFR26', 'serum concentration of infliximab']","[{'cui': 'C0021081', 'cui_str': 'Immunosuppressant agent'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1550100', 'cui_str': 'Serum specimen'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}]","[{'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C0004482', 'cui_str': 'Azathioprine'}]","[{'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",206.0,0.0609832,"Within quartiles of serum concentrations of infliximab, CSFR26 did not differ significantly between patients who received combination therapy vs monotherapy.","[{'ForeName': 'Jean-Frédéric', 'Initials': 'JF', 'LastName': 'Colombel', 'Affiliation': 'Department of Gastroenterology, Icahn School of Medicine, Mount Sinai Medical Center, New York, New York. Electronic address: jean-frederic.colombel@mssm.edu.'}, {'ForeName': 'Omoniyi J', 'Initials': 'OJ', 'LastName': 'Adedokun', 'Affiliation': 'Janssen Research & Development, Spring House, Pennsylvania.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Gasink', 'Affiliation': 'Janssen Scientific Affairs, Horsham, Pennsylvania.'}, {'ForeName': 'Long-Long', 'Initials': 'LL', 'LastName': 'Gao', 'Affiliation': 'Janssen Scientific Affairs, Horsham, Pennsylvania.'}, {'ForeName': 'Freddy J', 'Initials': 'FJ', 'LastName': 'Cornillie', 'Affiliation': 'MSD International, Kriens, Switzerland.'}, {'ForeName': 'Geert R', 'Initials': 'GR', 'LastName': ""D'Haens"", 'Affiliation': 'Department of Gastroenterology, Academic Medical Centre, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Rutgeerts', 'Affiliation': 'Department of Gastroenterology, University Hospital Gasthuisberg, Leuven, Belgium.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Reinisch', 'Affiliation': 'Universitätsklinik für Innere Medizin III, Vienna, Austria.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Sandborn', 'Affiliation': 'Division of Gastroenterology and Department of Medicine, University of California, San Diego, San Diego, California.'}, {'ForeName': 'Stephen B', 'Initials': 'SB', 'LastName': 'Hanauer', 'Affiliation': 'Department of Medicine, Digestive Health Center, Northwestern University, Feinberg School of Medicine, Chicago, Illinois.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2018.09.033']
1972,30471456,Histologic Analysis of Endoscopic Ultrasound-Guided Through the Needle Microforceps Biopsies Accurately Identifies Mucinous Pancreas Cysts.,"BACKGROUND & AIMS


It is a challenge to accurately assess pancreatic cystic lesions (PCLs) and determine their risk. We compared the yield of tissue acquired with endoscopic ultrasound (EUS)-guided microforceps (through the needle tissue biopsy [TTNB]) with that of samples collected by EUS-guided fine-needle-aspiration (EUS-FNA), and the accuracy of analyses of each sample type in the diagnosis of mucinous PCLs.
METHODS


We performed a prospective open-label study of 114 consecutive adults (56.1% women; mean age, 64.2 y) undergoing EUS-FNA evaluation of PCLs (mean size, 35 mm) at 7 centers, from June 20, 2016, through August 31, 2018. Samples were collected from each cyst by FNA and microforceps; samples collected by FNA were analyzed by cytology and samples collected by TTNB were analyzed by histology. Acquisition yield was defined as the percentage of specimens collected that were adequate for cytologic or histologic analysis. Diagnoses of mucinous cysts were made based on identification of pancreatic mucinous epithelium by cytology analysis of FNA samples or histologic analysis of TTNB samples. Surgical specimens were used as the reference standard when available.
RESULTS


The EUS-guided microforceps were successfully inserted into 97.4% (111 of 114) of PCLs. Tissue acquisition yield was significantly higher with TTNB (95 of 114; 83.3%) than FNA (43 of 114; 37.7%) (P < .001). Sixty-one PCLs were determined to be mucinous based on TTNB analysis (53.5%) vs 11 with FNA analysis (9.6%) (P < .001). Among PCLs categorized as equivocal, based on the level of carcinoembryonic antigen, TTNB analysis found 50% (41 of 82) to be mucinous and FNA analysis found 8.5% (7 of 82) to be mucinous (P < .001). Findings from analyses of samples collected by TTNB were 100% concordant with findings from histologic analysis of surgical specimens (14 of 14), whereas only 3 of 14 findings from analysis of samples collected by FNA were in agreement with findings from surgical specimens (21.4%) (P < .001). Four of 5 mucinous PCLs with advanced neoplasia (80%) were detected with TTNB compared with none with FNA (P = .04). Self-limited intracystic bleeding occurred in 7 patients (6.1%), and acute pancreatitis in 6 patients (5.3%).
CONCLUSIONS


In a multicenter prospective study of patients undergoing EUS-FNA for evaluation of PCLs, we found TTNB collection of tissues for histologic analysis to be safe and feasible, with an acquisition yield of 83.3%. Histologic analysis of samples collected by TTNB identified a larger proportion of mucinous PCLs compared with cytologic analysis of samples collected by FNA-even among samples categorized as equivocal, based on the level of carcinoembryonic antigen. More samples collected by TTNB than FNA were found to have advanced neoplasia. Clinicaltrials.gov no: NCT02979509.",2019,The EUS-guided microforceps were successfully inserted into 97.4% (111 of 114) of PCLs.,"['114 consecutive adults (56.1% women; mean age, 64.2 y) undergoing EUS-FNA evaluation of PCLs (mean size, 35 mm) at 7 centers, from June 20, 2016, through August 31, 2018', 'patients undergoing EUS-FNA for evaluation of PCLs']","['endoscopic ultrasound (EUS)-guided microforceps (through the needle tissue biopsy [TTNB]) with that of samples collected by EUS-guided fine-needle-aspiration (EUS-FNA', 'Endoscopic Ultrasound-Guided Through the Needle Microforceps Biopsies']","['acute pancreatitis', 'advanced neoplasia', 'Tissue acquisition yield', 'Self-limited intracystic bleeding']","[{'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0376443', 'cui_str': 'Endoscopic ultrasonography'}, {'cui': 'C1510483', 'cui_str': 'Fine needle aspiration biopsy - action'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0030274', 'cui_str': 'Pancreatic structure'}, {'cui': 'C0205207', 'cui_str': 'Cystic'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0376443', 'cui_str': 'Endoscopic ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C1880510', 'cui_str': 'EUS-FNA'}, {'cui': 'C1510483', 'cui_str': 'Fine needle aspiration biopsy - action'}]","[{'cui': 'C0001339', 'cui_str': 'Acute pancreatitis'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439801', 'cui_str': 'Limited'}]",114.0,0.0385691,The EUS-guided microforceps were successfully inserted into 97.4% (111 of 114) of PCLs.,"[{'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Yang', 'Affiliation': 'Division of Gastroenterology and Hepatology, University of Florida, Gainesville, Florida. Electronic address: dennis.yang@medicine.ufl.edu.'}, {'ForeName': 'Arvind J', 'Initials': 'AJ', 'LastName': 'Trindade', 'Affiliation': 'Division of Gastroenterology, Zucker School of Medicine at Hofstra/Northwell, Long Island Jewish Medical Center, Northwell Health System, New Hyde Park, New York.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Yachimski', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Petros', 'Initials': 'P', 'LastName': 'Benias', 'Affiliation': 'Division of Gastroenterology, Zucker School of Medicine at Hofstra/Northwell, Long Island Jewish Medical Center, Northwell Health System, New Hyde Park, New York.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Nieto', 'Affiliation': 'Borland-Groover Clinic, Jacksonville, Florida.'}, {'ForeName': 'Amar', 'Initials': 'A', 'LastName': 'Manvar', 'Affiliation': 'Division of Gastroenterology, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York.'}, {'ForeName': 'Sammy', 'Initials': 'S', 'LastName': 'Ho', 'Affiliation': 'Division of Gastroenterology, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York.'}, {'ForeName': 'Ashwini', 'Initials': 'A', 'LastName': 'Esnakula', 'Affiliation': 'Department of Pathology, Immunology and Laboratory Medicine, University of Florida, Gainesville, Florida.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Gamboa', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Amrita', 'Initials': 'A', 'LastName': 'Sethi', 'Affiliation': 'Division of Digestive and Liver Disease, Columbia University, Medical Center-New York Presbyterian Hospital, New York, New York.'}, {'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Gupte', 'Affiliation': 'Division of Gastroenterology and Hepatology, University of Florida, Gainesville, Florida.'}, {'ForeName': 'Harshit S', 'Initials': 'HS', 'LastName': 'Khara', 'Affiliation': 'Department of Gastroenterology and Hepatology, Geisinger Medical Center, Danville, Pennsylvania.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Diehl', 'Affiliation': 'Department of Gastroenterology and Hepatology, Geisinger Medical Center, Danville, Pennsylvania.'}, {'ForeName': 'Abdul', 'Initials': 'A', 'LastName': 'El Chafic', 'Affiliation': 'Division of Gastroenterology and Hepatology, Ochsner Medical Center, New Orleans, Louisiana.'}, {'ForeName': 'Janak', 'Initials': 'J', 'LastName': 'Shah', 'Affiliation': 'Division of Gastroenterology and Hepatology, Ochsner Medical Center, New Orleans, Louisiana.'}, {'ForeName': 'Christopher E', 'Initials': 'CE', 'LastName': 'Forsmark', 'Affiliation': 'Division of Gastroenterology and Hepatology, University of Florida, Gainesville, Florida.'}, {'ForeName': 'Peter V', 'Initials': 'PV', 'LastName': 'Draganov', 'Affiliation': 'Division of Gastroenterology and Hepatology, University of Florida, Gainesville, Florida.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2018.11.027']
1973,31028746,STRONGkids validation: tool accuracy.,"OBJECTIVE


Validate the accuracy of the Screening Tool for Risk on Nutritional status and Growth (STRONGkids) and estimate the prevalence of malnutrition and nutritional risk in hospitalized children.
METHODS


Cross-sectional study of a representative sample of children admitted to ten public pediatric emergency rooms. The sample was randomly estimated in stages, including children older than 30 days and younger than 10 years of age, of both sexes, excluding syndromic children and those in whom it was impossible to directly measure anthropometry. Weight, height, and arm circumference were measured, as well as the Z-scores of the anthropometric indices weight-for-age, height-for-age, weight-for-height, body mass index for age, and arm circumference for age, classified according to the reference curves of the World Health Organization. After the tool was applied, its accuracy tests were performed in comparison with the anthropometric data, with the evaluation of sensitivity, specificity, and positive and negative predictive values.
RESULTS


A total of 271 children were evaluated, 56.46% males and 41.70% younger than 2 years of age. The prevalence rates of malnutrition, nutritional risk assessed by anthropometric measurements, and nutritional risk assessed by the tool were 12.18%, 33.95%, and 78.60%, respectively. Accuracy showed sensitivity of 84.8%, specificity of 26.7%, positive predictive value of 49.8%, and negative predictive value of 67.2%, when the patients at nutritional risk were identified by anthropometry.
CONCLUSION


Validation of the accuracy of STRONGkids was performed, showing high sensitivity, allowing the early identification of nutritional risk in similar populations.",2020,"Accuracy showed sensitivity of 84.8%, specificity of 26.7%, positive predictive value of 49.8%, and negative predictive value of 67.2%, when the patients at nutritional risk were identified by anthropometry.
","['271 children were evaluated, 56.46% males and 41.70% younger than 2 years of age', 'hospitalized children', 'Cross-sectional study of a representative sample of children admitted to ten public pediatric emergency rooms', 'children older than 30 days and younger than 10 years of age, of both sexes, excluding syndromic children and those in whom it was impossible to directly measure anthropometry']",[],"['Weight, height, and arm circumference', 'prevalence rates of malnutrition, nutritional risk assessed by anthropometric measurements, and nutritional risk']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008098', 'cui_str': 'Children, Hospitalized'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}]",[],"[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C1268620', 'cui_str': 'At risk for nutritional problem'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",271.0,0.0201806,"Accuracy showed sensitivity of 84.8%, specificity of 26.7%, positive predictive value of 49.8%, and negative predictive value of 67.2%, when the patients at nutritional risk were identified by anthropometry.
","[{'ForeName': 'Juliana Rolim Vieira', 'Initials': 'JRV', 'LastName': 'Maciel', 'Affiliation': 'Universidade de Brasília, Departamento de Nutrição, Programa de Pós-Graduação em Nutrição Humana, Brasília, DF, Brazil. Electronic address: juliana.rolim@gmail.com.'}, {'ForeName': 'Eduardo Yoshio', 'Initials': 'EY', 'LastName': 'Nakano', 'Affiliation': 'Universidade de Brasília, Departamento de Estatística, Brasília, DF, Brazil.'}, {'ForeName': 'Kênia Mara Baiocchi de', 'Initials': 'KMB', 'LastName': 'Carvalho', 'Affiliation': 'Universidade de Brasília, Departamento de Nutrição, Programa de Pós-Graduação em Nutrição Humana, Brasília, DF, Brazil.'}, {'ForeName': 'Eliane Said', 'Initials': 'ES', 'LastName': 'Dutra', 'Affiliation': 'Universidade de Brasília, Departamento de Nutrição, Programa de Pós-Graduação em Nutrição Humana, Brasília, DF, Brazil.'}]",Jornal de pediatria,['10.1016/j.jped.2018.12.012']
1974,31250180,Radiomics-based prediction of microsatellite instability in colorectal cancer at initial computed tomography evaluation.,"PURPOSE


To predict microsatellite instability (MSI) status of colon cancer on preoperative CT imaging using radiomic analysis.
METHODS


This retrospective study involved radiomic analysis of preoperative CT imaging of patients who underwent resection of stage II-III colon cancer from 2004 to 2012. A radiologist blinded to MSI status manually segmented the tumor region on CT images. 254 Intensity-based radiomic features were extracted from the tumor region. Three prediction models were developed with (1) only clinical features, (2) only radiomic features, and (3) ""combined"" clinical and radiomic features. Patients were randomly separated into training (n = 139) and test (n = 59) sets. The model was constructed from training data only; the test set was reserved for validation only. Model performance was evaluated using AUC, sensitivity, specificity, PPV, and NPV.
RESULTS


Of the total 198 patients, 134 (68%) patients had microsatellite stable tumors and 64 (32%) patients had MSI tumors. The combined model performed slightly better than the other models, predicting MSI with an AUC of 0.80 for the training set and 0.79 for the test set (specificity = 96.8% and 92.5%, respectively), whereas the model with only clinical features achieved an AUC of 0.74 and the model with only radiomic features achieved an AUC of 0.76. The model with clinical features alone had the lowest specificity (70%) compared with the model with radiomic features alone (95%) and the combined model (92.5%).
CONCLUSIONS


Preoperative prediction of MSI status via radiomic analysis of preoperative CT adds specificity to clinical assessment and could contribute to personalized treatment selection.",2019,"The model with clinical features alone had the lowest specificity (70%) compared with the model with radiomic features alone (95%) and the combined model (92.5%).
","['Of the total 198 patients, 134 (68', 'patients who underwent resection of stage II-III colon cancer from 2004 to 2012', 'patients had microsatellite stable tumors and 64 (32%) patients had MSI tumors']",['preoperative CT imaging'],"['AUC, sensitivity, specificity, PPV, and NPV']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0007102', 'cui_str': 'Malignant tumor of colon'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C1519302', 'cui_str': 'Short Tandem Repeats'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0796369', 'cui_str': 'Microsatellite instability'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}]","[{'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0028586', 'cui_str': 'Nucleopolyhedrovirus'}]",,0.0245261,"The model with clinical features alone had the lowest specificity (70%) compared with the model with radiomic features alone (95%) and the combined model (92.5%).
","[{'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Golia Pernicka', 'Affiliation': 'Body Imaging Service, Department of Radiology, Evelyn H. Lauder Breast Center, Memorial Sloan Kettering Cancer Center, 300 East 66th St., Suite 757, New York, NY, 10065, USA. goliapej@mskcc.org.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Gagniere', 'Affiliation': 'Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Jayasree', 'Initials': 'J', 'LastName': 'Chakraborty', 'Affiliation': 'Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Rikiya', 'Initials': 'R', 'LastName': 'Yamashita', 'Affiliation': 'Body Imaging Service, Department of Radiology, Evelyn H. Lauder Breast Center, Memorial Sloan Kettering Cancer Center, 300 East 66th St., Suite 757, New York, NY, 10065, USA.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Nardo', 'Affiliation': 'Body Imaging Service, Department of Radiology, Evelyn H. Lauder Breast Center, Memorial Sloan Kettering Cancer Center, 300 East 66th St., Suite 757, New York, NY, 10065, USA.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Creasy', 'Affiliation': 'Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Iva', 'Initials': 'I', 'LastName': 'Petkovska', 'Affiliation': 'Body Imaging Service, Department of Radiology, Evelyn H. Lauder Breast Center, Memorial Sloan Kettering Cancer Center, 300 East 66th St., Suite 757, New York, NY, 10065, USA.'}, {'ForeName': 'Richard R K', 'Initials': 'RRK', 'LastName': 'Do', 'Affiliation': 'Body Imaging Service, Department of Radiology, Evelyn H. Lauder Breast Center, Memorial Sloan Kettering Cancer Center, 300 East 66th St., Suite 757, New York, NY, 10065, USA.'}, {'ForeName': 'David D B', 'Initials': 'DDB', 'LastName': 'Bates', 'Affiliation': 'Body Imaging Service, Department of Radiology, Evelyn H. Lauder Breast Center, Memorial Sloan Kettering Cancer Center, 300 East 66th St., Suite 757, New York, NY, 10065, USA.'}, {'ForeName': 'Viktoriya', 'Initials': 'V', 'LastName': 'Paroder', 'Affiliation': 'Body Imaging Service, Department of Radiology, Evelyn H. Lauder Breast Center, Memorial Sloan Kettering Cancer Center, 300 East 66th St., Suite 757, New York, NY, 10065, USA.'}, {'ForeName': 'Mithat', 'Initials': 'M', 'LastName': 'Gonen', 'Affiliation': 'Department of Epidemiology & Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Martin R', 'Initials': 'MR', 'LastName': 'Weiser', 'Affiliation': 'Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Amber L', 'Initials': 'AL', 'LastName': 'Simpson', 'Affiliation': 'Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Marc J', 'Initials': 'MJ', 'LastName': 'Gollub', 'Affiliation': 'Body Imaging Service, Department of Radiology, Evelyn H. Lauder Breast Center, Memorial Sloan Kettering Cancer Center, 300 East 66th St., Suite 757, New York, NY, 10065, USA.'}]",Abdominal radiology (New York),['10.1007/s00261-019-02117-w']
1975,33082988,Using motivational interviewing to enhance emerging adults' engagement in weight loss: The Live Well RVA pilot randomized clinical trial.,"Background


Emerging adults (ages 18-25) are at high risk for overweight/obesity, yet traditional adult behavioural weight loss (BWL) interventions do not meet the needs of individuals at this developmental stage. Motivational interviewing (MI) is an evidence-based approach to promote behaviour change but has not been tested for weight loss in this population. The study aimed to test the feasibility and preliminary efficacy of an MI-enhanced weight loss programme to promote engagement, retention and weight loss in emerging adults.
Methods


Emerging adults with overweight/obesity ( N  = 47, 81% female, 47% racial/ethnic minority, body mass index [BMI] = 33.2 ± 4.6 kg/m 2 ) were randomized to either standard BWL or MI-enhanced BWL (MIBWL). Weight was assessed objectively at baseline and posttreatment (3 months). Engagement (in-person session attendance [weeks 1 and 2], online self-monitoring [weeks 3-12] and online content viewing [weeks 3-12]) was tracked throughout the program.
Results


Though results did not reach the level of statistical significance, participants in MIBWL demonstrated greater programme engagement (77% vs. 61.0%,  p  = .11; Cohen  d  = .48), retention (71% vs. 48.0%,  p  = .10; Cohen  h  = .47) and intent-to-treat weight loss (-3.3% vs. -2.2%,  p  = .37; Cohen  d  = .26) compared with those in BWL.
Conclusions


Effect sizes suggest that MI might be a viable approach to enhance engagement and retention in weight loss programmes targeting emerging adults. This finding is meaningful, given the documented challenges with engagement and retention in this vulnerable population and the relationship between engagement and better weight loss outcomes. The results of this small pilot study support efforts to replicate these findings within the context of a fully powered trial.",2020,"Cohen  d  = .48), retention (71% vs. 48.0%,  p  = .10; Cohen  h  = .47) and intent-to-treat weight loss (-3.3% vs. -2.2%,  p  = .37; Cohen  d  = .26) compared with those in BWL.
","['adults with overweight/obesity ( N  = 47, 81% female, 47% racial/ethnic minority, body mass index [BMI] = 33.2 ± 4.6 kg/m 2 ', '\n\n\nEmerging adults (ages 18-25']","['online self-monitoring', 'Motivational interviewing (MI', 'standard BWL or MI-enhanced BWL (MIBWL', 'motivational interviewing', 'MI-enhanced weight loss programme']","['weight loss', 'intent-to-treat weight loss', 'Weight', 'retention', 'programme engagement']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517764', 'cui_str': '4.6'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0450335', 'cui_str': '18/25'}]","[{'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}]",,0.0968275,"Cohen  d  = .48), retention (71% vs. 48.0%,  p  = .10; Cohen  h  = .47) and intent-to-treat weight loss (-3.3% vs. -2.2%,  p  = .37; Cohen  d  = .26) compared with those in BWL.
","[{'ForeName': 'Jessica Gokee', 'Initials': 'JG', 'LastName': 'LaRose', 'Affiliation': 'Department of Health Behavior and Policy Virginia Commonwealth University School of Medicine Richmond Virginia USA.'}, {'ForeName': 'Amy A', 'Initials': 'AA', 'LastName': 'Gorin', 'Affiliation': 'Department of Psychological Sciences University of Connecticut Mansfield Connecticut USA.'}, {'ForeName': 'Joseph L', 'Initials': 'JL', 'LastName': 'Fava', 'Affiliation': 'Weight Control and Diabetes Research Center The Miriam Hospital Providence Rhode Island USA.'}, {'ForeName': 'Melanie K', 'Initials': 'MK', 'LastName': 'Bean', 'Affiliation': ""Department of Pediatrics Children's Hospital of Richmond at Virginia Commonwealth University Richmond Virginia USA.""}, {'ForeName': 'Autumn', 'Initials': 'A', 'LastName': 'Lanoye', 'Affiliation': 'Department of Health Behavior and Policy Virginia Commonwealth University School of Medicine Richmond Virginia USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Robinson', 'Affiliation': ""Department of Pediatrics Children's Hospital of Richmond at Virginia Commonwealth University Richmond Virginia USA.""}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Carey', 'Affiliation': 'Department of Behavioral and Social Sciences Brown University School of Public Health Providence Rhode Island USA.'}]",Obesity science & practice,['10.1002/osp4.435']
1976,33083560,High dose oral rifampicin to improve survival from adult tuberculous meningitis: A randomised placebo-controlled double-blinded phase III trial (the HARVEST study).,"Background:  Tuberculous meningitis (TBM), the most severe form of tuberculosis (TB), results in death or neurological disability in >50%, despite World Health Organisation recommended therapy. Current TBM regimen dosages are based on data from pulmonary TB alone. Evidence from recent phase II pharmacokinetic studies suggests that high dose rifampicin (R) administered intravenously or orally enhances central nervous system penetration and may reduce TBM associated mortality. We hypothesize that, among persons with TBM, high dose oral rifampicin (35 mg/kg) for 8 weeks will improve survival compared to standard of care (10 mg/kg), without excess adverse events.  Protocol:  We will perform a parallel group, randomised, placebo-controlled, double blind, phase III multicentre clinical trial comparing high dose oral rifampicin to standard of care. The trial will be conducted across five clinical sites in Uganda, South Africa and Indonesia. Participants are HIV-positive or negative adults with clinically suspected TBM, who will be randomised (1:1) to one of two arms: 35 mg/kg oral rifampicin daily for 8 weeks (in combination with standard dose isoniazid [H], pyrazinamide [Z] and ethambutol [E]) or standard of care (oral HRZE, containing 10 mg/kg/day rifampicin). The primary end-point is 6-month survival. Secondary end points are: i) 12-month survival ii) functional and neurocognitive outcomes and iii) safety and tolerability. Tertiary outcomes are: i) pharmacokinetic outcomes and ii) cost-effectiveness of the intervention. We will enrol 500 participants over 2.5 years, with follow-up continuing until 12 months post-enrolment.  Discussion:  Our best TBM treatment still results in unacceptably high mortality and morbidity. Strong evidence supports the increased cerebrospinal fluid penetration of high dose rifampicin, however conclusive evidence regarding survival benefit is lacking. This study will answer the important question of whether high dose oral rifampicin conveys a survival benefit in TBM in HIV-positive and -negative individuals from Africa and Asia.  Trial registration:  ISRCTN15668391 (17/06/2019).",2019,Evidence from recent phase II pharmacokinetic studies suggests that high dose rifampicin (R) administered intravenously or orally enhances central nervous system penetration and may reduce TBM associated mortality.,"['five clinical sites in Uganda, South Africa and Indonesia', 'adult tuberculous meningitis', '500 participants over 2.5 years, with follow-up continuing until 12 months post-enrolment', 'HIV-positive and -negative individuals from Africa and Asia', 'Participants are HIV-positive or negative adults with clinically suspected TBM']","['rifampicin (R', 'isoniazid [H], pyrazinamide [Z] and ethambutol [E]) or standard of care (oral HRZE, containing 10 mg/kg/day rifampicin', 'placebo', 'rifampicin']","['i) 12-month survival ii) functional and neurocognitive outcomes and iii) safety and tolerability', 'i) pharmacokinetic outcomes and ii) cost-effectiveness of the intervention', 'death or neurological disability', 'survival', 'mortality and morbidity', '6-month survival']","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0021247', 'cui_str': 'Indonesia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0041318', 'cui_str': 'Tuberculosis of meninges'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0019699', 'cui_str': 'HIV positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001737', 'cui_str': 'Africa'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0040341', 'cui_str': 'Tobramycin'}]","[{'cui': 'C0035608', 'cui_str': 'Rifampin'}, {'cui': 'C0022209', 'cui_str': 'isoniazid'}, {'cui': 'C0034239', 'cui_str': 'Pyrazinamide'}, {'cui': 'C0014964', 'cui_str': 'Ethambutol'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C3665414', 'cui_str': 'mg/kg/day'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",500.0,0.631725,Evidence from recent phase II pharmacokinetic studies suggests that high dose rifampicin (R) administered intravenously or orally enhances central nervous system penetration and may reduce TBM associated mortality.,"[{'ForeName': 'Suzaan', 'Initials': 'S', 'LastName': 'Marais', 'Affiliation': 'Department of Neurology, Inkosi Albert Luthuli Central Hospital, Durban, 4091, South Africa.'}, {'ForeName': 'Fiona V', 'Initials': 'FV', 'LastName': 'Cresswell', 'Affiliation': 'Infectious Diseases Institute, Mulago College of Health Sciences, Kampala, PO Box 22418, Uganda.'}, {'ForeName': 'Raph L', 'Initials': 'RL', 'LastName': 'Hamers', 'Affiliation': 'Eijkman-Oxford Clinical Research Unit, Jakarta, Indonesia.'}, {'ForeName': 'Lindsey H M', 'Initials': 'LHM', 'LastName': 'Te Brake', 'Affiliation': 'Department of Pharmacy, Radboud Institute for Health Sciences, Radboud University Medical Centre, Nijmegen, The Netherlands.'}, {'ForeName': 'Ahmad R', 'Initials': 'AR', 'LastName': 'Ganiem', 'Affiliation': 'Department of Neurology, Faculty of Medicine, Universitas Padjadjaran/ Hasan Sadikin Hospital, Bandung, 40161, Indonesia.'}, {'ForeName': 'Darma', 'Initials': 'D', 'LastName': 'Imran', 'Affiliation': 'Department of Neurology, Faculty of Medicine, Universitas Indonesia, Dr Cipto Mangukusumo Hospital, Jakarta, 10430, Indonesia.'}, {'ForeName': 'Ananta', 'Initials': 'A', 'LastName': 'Bangdiwala', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, MN, 55455, USA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Martyn', 'Affiliation': 'Infectious Diseases Institute, Mulago College of Health Sciences, Kampala, PO Box 22418, Uganda.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Kasibante', 'Affiliation': 'Infectious Diseases Institute, Mulago College of Health Sciences, Kampala, PO Box 22418, Uganda.'}, {'ForeName': 'Enock', 'Initials': 'E', 'LastName': 'Kagimu', 'Affiliation': 'Infectious Diseases Institute, Mulago College of Health Sciences, Kampala, PO Box 22418, Uganda.'}, {'ForeName': 'Abdu', 'Initials': 'A', 'LastName': 'Musubire', 'Affiliation': 'Infectious Diseases Institute, Mulago College of Health Sciences, Kampala, PO Box 22418, Uganda.'}, {'ForeName': 'Kartika', 'Initials': 'K', 'LastName': 'Maharani', 'Affiliation': 'Department of Neurology, Faculty of Medicine, Universitas Indonesia, Dr Cipto Mangukusumo Hospital, Jakarta, 10430, Indonesia.'}, {'ForeName': 'Riwanti', 'Initials': 'R', 'LastName': 'Estiasari', 'Affiliation': 'Department of Neurology, Faculty of Medicine, Universitas Indonesia, Dr Cipto Mangukusumo Hospital, Jakarta, 10430, Indonesia.'}, {'ForeName': 'Ardiana', 'Initials': 'A', 'LastName': 'Kusumaningrum', 'Affiliation': 'Department of Microbiology, Faculty of Medicine, Universitas Indonesia, Dr Cipto Mangukusumo Hospital, Jakarta, 10430, Indonesia.'}, {'ForeName': 'Nadytia', 'Initials': 'N', 'LastName': 'Kusumadjayanti', 'Affiliation': 'Infectious Disease Research Centre, Faculty of Medicine, Universitas Padjadaran, Bandung, 40161, Indonesia.'}, {'ForeName': 'Vycke', 'Initials': 'V', 'LastName': 'Yunivita', 'Affiliation': 'Department of Neurology, Faculty of Medicine, Universitas Padjadjaran/ Hasan Sadikin Hospital, Bandung, 40161, Indonesia.'}, {'ForeName': 'Kogieleum', 'Initials': 'K', 'LastName': 'Naidoo', 'Affiliation': 'Centre for the AIDS programme of research in South Africa (CAPRISA), Doris Duke Medical Research Institute, Durban, 4041, South Africa.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Lessells', 'Affiliation': 'Centre for the AIDS programme of research in South Africa (CAPRISA), Doris Duke Medical Research Institute, Durban, 4041, South Africa.'}, {'ForeName': 'Yunus', 'Initials': 'Y', 'LastName': 'Moosa', 'Affiliation': 'Department of Infectious Diseases, Division of Internal Medicine, Nelson R Mandela School of Medicine, University of KwaZulu-Natal, Durban, 4013, South Africa.'}, {'ForeName': 'Elin M', 'Initials': 'EM', 'LastName': 'Svensson', 'Affiliation': 'Department of Pharmacy, Radboud Institute for Health Sciences, Radboud University Medical Centre, Nijmegen, The Netherlands.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Huppler Hullsiek', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, MN, 55455, USA.'}, {'ForeName': 'Rob E', 'Initials': 'RE', 'LastName': 'Aarnoutse', 'Affiliation': 'Department of Pharmacy, Radboud Institute for Health Sciences, Radboud University Medical Centre, Nijmegen, The Netherlands.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Boulware', 'Affiliation': 'Division of Medicine, University of Minnesota, Minneapolis, MN, 55455, USA.'}, {'ForeName': 'Reinout', 'Initials': 'R', 'LastName': 'van Crevel', 'Affiliation': 'Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Rovina', 'Initials': 'R', 'LastName': 'Ruslami', 'Affiliation': 'Infectious Disease Research Centre, Faculty of Medicine, Universitas Padjadaran, Bandung, 40161, Indonesia.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Meya', 'Affiliation': 'Infectious Diseases Institute, Mulago College of Health Sciences, Kampala, PO Box 22418, Uganda.'}]",Wellcome open research,['10.12688/wellcomeopenres.15565.2']
1977,33083628,Peri-implant soft tissue integration in humans - influence of materials: A study protocol for a randomised controlled trial and a pilot study results.,"Background


Recently, there has been a growing interest in mucointegration as the formation of an early and long-standing soft tissue barrier seems essential for both the initial healing and long-term implant survival.
Aim


To develop an experimental method to characterize the mucointegration of different transgingival materials (titanium (Ti), polyetheretherketone (PEEK), polymethylmethacrylate (PMMA), zirconia (Zi), polymer infiltrated ceramic network (PICN), cobalt-chrome (Co-Cr), and lithium disilicate (LD)) in a human model.
Methods


The study is designed as a multi-part randomized controlled clinical trial. Ninety bone level Straumann implants will randomly receive an experimental, custom-made abutment to allow for the removal of the abutment together with the surrounding soft tissues using a punch biopsy device at 8 weeks of healing (10 per material). The specimens will be further processed for non-decalcified histology, followed by histomorphometric analysis. The same protocol will be used for additional 90 implants-abutments, but during harvesting, soft tissues will be separated from the abutment and processed for immunohistochemistry in order to study tissue inflammation and vascularization, while the abutments will undergo SEM analysis. Additionally,  in vitro  analyses, including SEM and profilometry, will be performed in order to characterize surface topography of all experimental materials.
Conclusion


The limited number of pilot samples presented herein indicate that the use of custom-made abutments in humans is a reproducible method to study peri-implant soft tissue integration. This further intensifies the rationale to compare different abutment materials, used as transgingival components in daily practice, under the same conditions.",2020,"This further intensifies the rationale to compare different abutment materials, used as transgingival components in daily practice, under the same conditions.","['Ninety bone level Straumann implants', 'humans - influence of materials']","['Peri-implant soft tissue integration', 'transgingival materials (titanium (Ti), polyetheretherketone (PEEK), polymethylmethacrylate (PMMA), zirconia (Zi), polymer infiltrated ceramic network (PICN), cobalt-chrome (Co-Cr), and lithium disilicate (LD']",[],"[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0520510', 'cui_str': 'Material'}]","[{'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0040302', 'cui_str': 'Titanium'}, {'cui': 'C0084113', 'cui_str': 'polyetheretherketone'}, {'cui': 'C0005533', 'cui_str': 'Polymethyl methacrylate'}, {'cui': 'C0078814', 'cui_str': 'zirconium oxide'}, {'cui': 'C0032521', 'cui_str': 'Polymer'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0007742', 'cui_str': 'Ceramic'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0008576', 'cui_str': 'Cobalt-chromium alloy'}, {'cui': 'C1528812', 'cui_str': 'lithia disilicate'}]",[],90.0,0.0412248,"This further intensifies the rationale to compare different abutment materials, used as transgingival components in daily practice, under the same conditions.","[{'ForeName': 'Manon', 'Initials': 'M', 'LastName': 'Borie', 'Affiliation': 'Department of Periodontology and Oral Surgery, University Hospital of Liège, Belgium.'}, {'ForeName': 'Geoffrey', 'Initials': 'G', 'LastName': 'Lecloux', 'Affiliation': 'Department of Periodontology and Oral Surgery, University Hospital of Liège, Belgium.'}, {'ForeName': 'Dieter', 'Initials': 'D', 'LastName': 'Bosshardt', 'Affiliation': 'Robert K. Schenk Laboratory of Oral Histology, School of Dental Medicine, University of Bern, Switzerland.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Barrantes', 'Affiliation': 'Department of Biomaterials, Institute of Clinical Dentistry, Faculty of Dentistry, University of Oslo, Norway.'}, {'ForeName': 'Håvard Jostein', 'Initials': 'HJ', 'LastName': 'Haugen', 'Affiliation': 'Department of Biomaterials, Institute of Clinical Dentistry, Faculty of Dentistry, University of Oslo, Norway.'}, {'ForeName': 'France', 'Initials': 'F', 'LastName': 'Lambert', 'Affiliation': 'Dental Biomaterials Research Unit, Faculty of Medicine, University of Liège, Belgium; Department of Periodontology and Oral Surgery, University Hospital of Liège, Belgium.'}, {'ForeName': 'Miljana', 'Initials': 'M', 'LastName': 'Bacevic', 'Affiliation': 'Dental Biomaterials Research Unit, Faculty of Medicine, University of Liège, Belgium.'}]",Contemporary clinical trials communications,['10.1016/j.conctc.2020.100643']
1978,33083630,A randomized controlled trial of a home-based exercise program on prognostic biomarkers in men with prostate cancer: A study protocol.,"Background


Herein, we propose a novel RCT study to collect preliminary data on the impact of a 24-week home-based exercise program that can improve prognosis, physical function, and quality of life (QoL) in men with prostate cancer (PCa). This study will provide data on the feasibility of conducting a home-based exercise study and pilot data on the impact of exercise on circulating concentrations of biomarkers reported in the literature to be beneficial for the prognostication of PCa.
Methods/design


Thirty male patients, clinically-diagnosed with prostate cancer under active surveillance, will be recruited to participate in a 2-arm, 24-week home-based program .  Random allocation to each arm - intervention, and control - will be performed in a 1:1 ratio. Participants assigned to the intervention group will perform 30 min of light-to-moderate intensity walking five days a week (40-60% heart rate reserve) and three sets of 15 repetitions of light callisthenic exercises (bodyweight squats, incline push-ups, and hip thrusts) 3 days a week. Participants randomized to the control group will maintain normal activity throughout the 24 weeks. Four visits occurring at baseline, 12-, 18-, and 24-weeks will be used to assess QoL, body composition, prognostic biomarker concentrations, and overall physical function. Primary endpoints include significant changes in prognostic biomarkers. Secondary endpoints include changes in quality of life, physical function and body composition.
Discussion


This study should demonstrate preliminary evidence that a home-based exercise intervention can impact biomarkers of progression while improving quality of life, physical function and body composition. Results from this study have the potential to promote health and wellness while minimizing cancer progression in men with PCa.",2020,"This study should demonstrate preliminary evidence that a home-based exercise intervention can impact biomarkers of progression while improving quality of life, physical function and body composition.","['men with prostate cancer', 'men with PCa', 'men with prostate cancer (PCa', 'Thirty male patients, clinically-diagnosed with prostate cancer under active surveillance']","['home-based exercise intervention', 'intervention group will perform 30\xa0min of light-to-moderate intensity walking five days a week (40-60% heart rate reserve) and three sets of 15 repetitions of light callisthenic exercises (bodyweight squats, incline push-ups, and hip thrusts) 3 days a week', 'home-based exercise program']","['quality of life, physical function and body composition', 'QoL, body composition, prognostic biomarker concentrations, and overall physical function', 'prognostic biomarkers', 'changes in quality of life, physical function and body composition', 'prognosis, physical function, and quality of life (QoL']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0700325', 'cui_str': 'Patient status observation'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0580841', 'cui_str': 'Does push'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0033325', 'cui_str': 'Determination of prognosis'}]",30.0,0.073576,"This study should demonstrate preliminary evidence that a home-based exercise intervention can impact biomarkers of progression while improving quality of life, physical function and body composition.","[{'ForeName': 'Darpan I', 'Initials': 'DI', 'LastName': 'Patel', 'Affiliation': 'School of Nursing, University of Texas Health at San Antonio, San Antonio, TX, 78229, USA.'}, {'ForeName': 'Amber M', 'Initials': 'AM', 'LastName': 'Gallegos', 'Affiliation': 'School of Nursing, University of Texas Health at San Antonio, San Antonio, TX, 78229, USA.'}, {'ForeName': 'Bilal', 'Initials': 'B', 'LastName': 'Sheikh', 'Affiliation': 'School of Nursing, University of Texas Health at San Antonio, San Antonio, TX, 78229, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Vardeman', 'Affiliation': 'School of Nursing, University of Texas Health at San Antonio, San Antonio, TX, 78229, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Liss', 'Affiliation': 'Department of Urology, School of Medicine, University of Texas Health at San Antonio, San Antonio, TX, 78229, USA.'}]",Contemporary clinical trials communications,['10.1016/j.conctc.2020.100659']
1979,33083903,"Metasul vs Cerasul bearings: a prospective, randomized study at a mean eighteen years.","BACKGROUND


The aims of our study were to compare the clinical, radiographic outcomes and survivals between second-generation metal-on-metal (Metasul) and ceramic-on-ceramic (Cerasul) bearings at a very long-term follow-up.
METHODS


A prospective, randomized study was originally performed on a consecutive series of 250 cementless, 28-mm head and primary total hip arthroplasties between 1999 and 2002. For each bearing (Metasul or Cerasul), 125 THAs were initially included. All cases were evaluated both clinically and radiographically, and survival was assessed, considering revisions for aseptic loosening or for any reason as the end points for failure.
RESULTS


At a mean 18-year follow-up, clinical and radiographic outcomes were similar. Harris Hip Score increased 30% in the Metasul group and 32% in the Cerasul group (p = 0.6). Survival free of aseptic loosening was higher for Cerasul (100%), than for Metasul (94% [CI 88-99.9]) (p = 0.04). Survival free of any revision was 91% ([CI 84-98%]) for Cerasul and 91% ([CI 84-98%]) for Metasul. Fractures of Cerasul insert occurred in four cases (3%) at a mean 12.5 ± 3.3 years (range, 6 to 17 years).
CONCLUSION


At 18 years, Cerasul demonstrated higher survivorship than Metasul considering aseptic loosening as an end point. However, Cerasul liners had high rate of fracture because of its sandwich design (thin ceramic liner into polyethylene). These implants are no more available on the market.",2020,"Survival free of aseptic loosening was higher for Cerasul (100%), than for Metasul (94% [CI 88-99.9]) (p = 0.04).","['mean eighteen years', 'consecutive series of 250 cementless, 28-mm head and primary total hip arthroplasties between 1999 and 2002']","['second-generation metal-on-metal (Metasul) and ceramic-on-ceramic (Cerasul) bearings', 'Metasul vs Cerasul bearings']","['Harris Hip Score', 'Fractures of Cerasul insert', 'Survival free of any revision', 'Survival free of aseptic loosening']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205549', 'cui_str': 'Series'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}]","[{'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0025552', 'cui_str': 'Metal'}, {'cui': 'C0007742', 'cui_str': 'Ceramic'}]","[{'cui': 'C2919875', 'cui_str': 'Harris hip score'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0439616', 'cui_str': 'Revisions'}, {'cui': 'C0232920', 'cui_str': 'Sterile'}, {'cui': 'C0333050', 'cui_str': 'Loosening'}]",125.0,0.0378618,"Survival free of aseptic loosening was higher for Cerasul (100%), than for Metasul (94% [CI 88-99.9]) (p = 0.04).","[{'ForeName': 'Quentin', 'Initials': 'Q', 'LastName': 'Andeol', 'Affiliation': 'Hospices Civils de Lyon, Hôpital Lyon Sud, Service de Chirurgie Orthopédique et Traumatologique, 165 Chemin du Grand Revoyet, 69495, Pierre Bénite Cedex, France.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Viste', 'Affiliation': 'Hospices Civils de Lyon, Hôpital Lyon Sud, Service de Chirurgie Orthopédique et Traumatologique, 165 Chemin du Grand Revoyet, 69495, Pierre Bénite Cedex, France. anthony.viste@chu-lyon.fr.'}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Desmarchelier', 'Affiliation': 'Hospices Civils de Lyon, Hôpital Lyon Sud, Service de Chirurgie Orthopédique et Traumatologique, 165 Chemin du Grand Revoyet, 69495, Pierre Bénite Cedex, France.'}, {'ForeName': 'Jean-Luc', 'Initials': 'JL', 'LastName': 'Lerat', 'Affiliation': 'Hospices Civils de Lyon, Hôpital Lyon Sud, Service de Chirurgie Orthopédique et Traumatologique, 165 Chemin du Grand Revoyet, 69495, Pierre Bénite Cedex, France.'}, {'ForeName': 'Michel-Henri', 'Initials': 'MH', 'LastName': 'Fessy', 'Affiliation': 'Hospices Civils de Lyon, Hôpital Lyon Sud, Service de Chirurgie Orthopédique et Traumatologique, 165 Chemin du Grand Revoyet, 69495, Pierre Bénite Cedex, France.'}]",International orthopaedics,['10.1007/s00264-020-04855-9']
1980,33083913,Combination of TAS-102 and bevacizumab as third-line treatment for metastatic colorectal cancer: TAS-CC3 study.,"BACKGROUND


TAS-102 improved the overall survival of metastatic colorectal cancer (CRC) patients with a median progression-free survival (PFS) in the RECOURSE trial. Subsequently, the combination of TAS-102 and bevacizumab was shown to extend the median PFS (C-TASK FORCE study). However, the study included patients who received second- and third-line treatment. Our study exclusively examined patients receiving this combination as a third-line treatment to investigate the clinical impact beyond cytotoxic doublets.
METHODS


This investigator-initiated, open-label, single-arm, multi-centered phase II study was conducted in Japan. Eligible CRC patients were refractory or intolerant to fluoropyrimidine, irinotecan, and oxaliplatin in first- and second-line therapy. TAS-102 (35 mg/m 2 ) was given orally twice daily on days 1-5 and 8-12 in a 4-week cycle, and bevacizumab (5 mg/kg) was administered by intravenous infusion every 2 weeks. The primary endpoint was PFS and the secondary endpoints were time-to-treatment failure, response rate, overall survival (OS), and safety.
RESULTS


Between June 2016 and August 2017, 32 patients were enrolled. All patients previously received bevacizumab. The median PFS was 4.5 months; the median overall survival was 9.3 months. Partial response was observed in two patients. The most common adverse events above grade 3 were neutropenia followed by thrombocytopenia. There were no non-hematological adverse events above grade 3 and no treatment-related deaths occurred.
CONCLUSIONS


This study met its primary endpoint of PFS, which is comparable to the results of the C-TASK FORCE study. The TAS-102 and bevacizumab combination has the potential to be a therapeutic option for third-line treatment of metastatic CRC.",2020,"BACKGROUND


TAS-102 improved the overall survival of metastatic colorectal cancer (CRC) patients with a median progression-free survival (PFS) in the RECOURSE trial.","['metastatic colorectal cancer', 'Eligible CRC patients were refractory or intolerant to', 'metastatic colorectal cancer (CRC) patients with a median progression-free survival (PFS', 'Between June 2016 and August 2017, 32 patients were enrolled']","['fluoropyrimidine, irinotecan, and oxaliplatin in first- and second-line therapy', 'TAS-102 and bevacizumab', 'TAS-102', 'bevacizumab']","['hematological adverse events', 'time-to-treatment failure, response rate, overall survival (OS), and safety', 'Partial response', 'median overall survival', 'overall survival', 'median PFS']","[{'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]","[{'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C1710038', 'cui_str': 'Second line treatment'}, {'cui': 'C1451803', 'cui_str': 'TAS-102'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3494202', 'cui_str': 'Time to Treatment'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",32.0,0.0465772,"BACKGROUND


TAS-102 improved the overall survival of metastatic colorectal cancer (CRC) patients with a median progression-free survival (PFS) in the RECOURSE trial.","[{'ForeName': 'Yoichiro', 'Initials': 'Y', 'LastName': 'Yoshida', 'Affiliation': 'Department of Gastroenterological Surgery, Faculty of Medicine, Fukuoka University, Fukuoka University School of Medicine, 7-45-1 Nanakuma, Jonan-ku, Fukuoka, 814-0180, Japan. yyoshida@fukuoka-u.ac.jp.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Yamada', 'Affiliation': 'Department of Gastrointestinal and Hepato-Biliary-Pancreatic Surgery, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Hirohiko', 'Initials': 'H', 'LastName': 'Kamiyama', 'Affiliation': 'Department of Coloproctological Surgery, Faculty of Medicine, Juntendo University, Tokyo, Japan.'}, {'ForeName': 'Chihiro', 'Initials': 'C', 'LastName': 'Kosugi', 'Affiliation': 'Department of Surgery, Teikyo University Chiba Medical Center, Chiba, Japan.'}, {'ForeName': 'Keiichiro', 'Initials': 'K', 'LastName': 'Ishibashi', 'Affiliation': 'Department of Digestive Tract and General Surgery, Saitama Medical Center, Saitama Medical University, Saitama, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Yoshida', 'Affiliation': 'Department of Gastrointestinal and Hepato-Biliary-Pancreatic Surgery, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Hideyuki', 'Initials': 'H', 'LastName': 'Ishida', 'Affiliation': 'Department of Digestive Tract and General Surgery, Saitama Medical Center, Saitama Medical University, Saitama, Japan.'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Yamaguchi', 'Affiliation': 'Department of Surgical Oncology, Dokkyo Medical University, Tochigi, Japan.'}, {'ForeName': 'Hidekazu', 'Initials': 'H', 'LastName': 'Kuramochi', 'Affiliation': ""Department of Chemotherapy, Tokyo Women's Medical University Yachiyo Medical Center, Chiba, Japan.""}, {'ForeName': 'Atsuko', 'Initials': 'A', 'LastName': 'Fukazawa', 'Affiliation': 'Department of Gastroenterological Surgery, Iwata City Hospital, Shizuoka, Japan.'}, {'ForeName': 'Hiromichi', 'Initials': 'H', 'LastName': 'Sonoda', 'Affiliation': 'Department of Surgery, Shiga University of Medical Science, Shiga, Japan.'}, {'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Yoshimatsu', 'Affiliation': 'Department of Surgery, Saiseikai Kurihashi Hospital, Saitama, Japan.'}, {'ForeName': 'Akihisa', 'Initials': 'A', 'LastName': 'Matsuda', 'Affiliation': 'Department of Surgery, Nippon Medical School Chiba Hokuso Hospital, Chiba, Japan.'}, {'ForeName': 'Suguru', 'Initials': 'S', 'LastName': 'Hasegawa', 'Affiliation': 'Department of Gastroenterological Surgery, Faculty of Medicine, Fukuoka University, Fukuoka University School of Medicine, 7-45-1 Nanakuma, Jonan-ku, Fukuoka, 814-0180, Japan.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Sakamoto', 'Affiliation': 'Department of Coloproctological Surgery, Faculty of Medicine, Juntendo University, Tokyo, Japan.'}, {'ForeName': 'Toshiaki', 'Initials': 'T', 'LastName': 'Otsuka', 'Affiliation': 'Dept of Hygiene and Public Health, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Keiji', 'Initials': 'K', 'LastName': 'Koda', 'Affiliation': 'Department of Surgery, Teikyo University Chiba Medical Center, Chiba, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",International journal of clinical oncology,['10.1007/s10147-020-01794-8']
1981,33084019,"Education intervention with respect to the oral health knowledge, attitude, and behaviors of refugee families: A randomized clinical trial of effectiveness.","OBJECTIVES


The study assessed the effectiveness of an oral health educational and behavioral intervention program in improving the knowledge, attitudes, and behaviors of refugee families.
METHODS


This randomized 2-arms, controlled, single site, clinical trial assessed the dental knowledge, attitudes, and behaviors related to oral health at baseline and three times over the course of the 6 months of the intervention in recent refugee families. Participating families were educated on five topics in oral health in two 1-hour sessions utilizing existing oral health education materials adapted to be linguistically and culturally appropriate for demonstration and instruction. Culturally competent techniques and motivational interviewing styles were also implemented during sessions. Pre/post surveys were used to assess changes to knowledge, attitudes, and behavior among refugee family participants.
RESULTS


Out of the 66 families enrolled in the program, 52 (72 percent) completed visits over the course of 6 months. Differences between the intervention and control groups were not significant between baseline and 3 to 6 months later (P > 0.05).
CONCLUSIONS


A short-term, culturally informed oral health educational and behavioral intervention program did not improve oral health-related knowledge, attitudes, or behaviors in a diverse group of recent refugee families.",2020,"CONCLUSIONS


A short-term, culturally informed oral health educational and behavioral intervention program did not improve oral health-related knowledge, attitudes, or behaviors in a diverse group of recent refugee families.","['Out of the 66 families enrolled in the program, 52 (72 percent) completed visits over the course of 6 months']","['oral health educational and behavioral intervention program', 'Education intervention']","['knowledge, attitudes, and behavior among refugee family participants', 'knowledge, attitudes, and behaviors of refugee families', 'oral health-related knowledge, attitudes, or behaviors', 'dental knowledge, attitudes, and behaviors related to oral health']","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1446393', 'cui_str': 'Refugee family'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}]",66.0,0.019455,"CONCLUSIONS


A short-term, culturally informed oral health educational and behavioral intervention program did not improve oral health-related knowledge, attitudes, or behaviors in a diverse group of recent refugee families.","[{'ForeName': 'Murad', 'Initials': 'M', 'LastName': 'Alrashdi', 'Affiliation': 'Department of Orthodontic and Pediatric Dentistry, College of Dentistry, Qassim University, Buraydah, Saudi Arabia.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Hameed', 'Affiliation': 'Biology Department, University of Texas, San Antonio, TX, USA.'}, {'ForeName': 'Maria Jose', 'Initials': 'MJ', 'LastName': 'Cervantes Mendez', 'Affiliation': 'Department of Developmental Dentistry, School of Dentistry at the University of Texas Health Science Center at San Antonio, San Antonio, TX, USA.'}, {'ForeName': 'Moshtagh', 'Initials': 'M', 'LastName': 'Farokhi', 'Affiliation': 'Department of Comprehensive Dentistry, School of Dentistry at the University of Texas Health Science Center at San Antonio, San Antonio, TX, USA.'}]",Journal of public health dentistry,['10.1111/jphd.12415']
1982,33084049,Rectus femoris transfer in children with cerebral palsy: comparing a propensity score-matched observational study to a randomized controlled trial.,"AIM


To test whether an observational study employing propensity score matching could accurately estimate the causal treatment effects of rectus femoris transfer (RFT) as part of single-event multilevel surgery (SEMLS) in ambulatory children with cerebral palsy.
METHOD


We used a large clinical database to derive a propensity score for treatment assignment (SEMLS±RFT) and used this score to generate a matched patient cohort. We compared the causal treatment effects estimated from this matched cohort with a previously published randomized controlled trial (RCT).
RESULTS


The treated arms of the observational study and RCT were well matched. There were 129 limbs (81 males) with a mean age of 10 years 7 months (4y 7mo) in the treated arm of the observational study, and 129 limbs (68 males) with a mean age of 10 years 2 months (3y 9mo) in the control arm of the observational study. Differences between the observational study and RCT cohorts were clinically meaningless for knee flexion kinematics (1-4°), timing of knee angle extrema (<3% gait cycle), and speed (<5mm/s). Postoperative changes in the observational study matched those from the RCT. All but one of the observational study confidence intervals were completely contained within the corresponding RCT confidence interval; there were no meaningful differences in magnitude or sign of key outcomes related to stiff knee gait.
INTERPRETATION


Propensity score matching is an accurate method for estimating the causal treatment effects of RFT as part of an SEMLS. It seems reasonable to extend this approach to other common components of SEMLS treatment in this population.",2020,"Differences between the observational study and RCT cohorts were clinically meaningless for knee flexion kinematics (1-4°), timing of knee angle extrema (<3% gait cycle), and speed (<5mm/s).","['ambulatory children with cerebral palsy', 'There were 129 limbs (81 males) with a mean age of 10\xa0years 7\xa0months (4y 7mo) in the treated arm of the observational study, and 129 limbs (68 males) with a mean age of 10\xa0years 2\xa0months (3y 9mo) in the control arm of the observational study', 'children with cerebral palsy']","['rectus femoris transfer (RFT', 'single-event multilevel surgery (SEMLS']",['knee flexion kinematics'],"[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C1520439', 'cui_str': '129 Strain Mouse'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C1518527', 'cui_str': 'Observational Study'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0584894', 'cui_str': 'Rectus femoris muscle structure'}, {'cui': 'C0585347', 'cui_str': 'Single event'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}]",,0.0759319,"Differences between the observational study and RCT cohorts were clinically meaningless for knee flexion kinematics (1-4°), timing of knee angle extrema (<3% gait cycle), and speed (<5mm/s).","[{'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Schwartz', 'Affiliation': ""Center for Gait and Motion Analysis, Gillette Children's Specialty Healthcare, St Paul, MN, USA.""}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Ries', 'Affiliation': ""Center for Gait and Motion Analysis, Gillette Children's Specialty Healthcare, St Paul, MN, USA.""}]",Developmental medicine and child neurology,['10.1111/dmcn.14709']
1983,33082990,Feasibility and acceptability of a remotely-delivered behavioural health coaching intervention to limit gestational weight gain.,"Introduction


Gestational weight gain (GWG) and postpartum weight retention (PPWR) are significant, potentially modifiable, contributors to women's future weight and health trajectories. There is a need for feasible and patient-centered (i.e., convenient, remotely-delivered, technology-enhanced, and accessible through the prenatal care setting) behavioural interventions that limit GWG and PPWR. This study tests the feasibility and acceptability of a remotely-delivered behavioural health coaching intervention to limit gestational weight gain and postpartum weight retention.
Methods


Pregnant women (11-16 weeks gestation) were recruited from two prenatal clinics and randomized to the active intervention or health education comparison group. Completion of the program was monitored and perceived helpfulness was rated (0-100).
Results


Twenty-six women were randomized ( n  = 13 per arm; mean age = 31.6 years, SD = 3.6; mean BMI = 26.7 kg/m 2 , SD = 7.4). Participants completed a median of 18 coaching calls and 16/19 learning activities during pregnancy, and a median of 6 calls and 5/6 learning activities postpartum. They logged weights at least once/week for a median of 36/38 expected weeks and tracked daily calories and exercise for a median of 154/266 days and 72/266 days, respectively. Median (Q1, Q3) helpfulness ratings of the program during pregnancy were 80 (64, 91) and 62 (50, 81) postpartum; helpfulness ratings of coaching calls were 85 (58, 98). At 37 weeks gestation, 77% of participants achieved IOM weight gain recommendations compared to 54% in the comparison group.
Conclusions


This study provides evidence for the feasibility and acceptability of a remotely-delivered behavioural weight control intervention in pregnancy and postpartum.",2020,"At 37 weeks gestation, 77% of participants achieved IOM weight gain recommendations compared to 54% in the comparison group.
","['Methods\n\n\nPregnant women (11-16 weeks gestation', 'Twenty-six women were randomized ( n  = 13 per arm', 'Participants completed a median of 18 coaching calls and 16/19 learning activities during pregnancy, and a median of 6 calls and 5/6 learning activities postpartum', 'mean age = 31.6 years, SD = 3.6']","['behavioural weight control intervention', 'active intervention or health education comparison group', 'remotely-delivered behavioural health coaching intervention']","['Introduction\n\n\nGestational weight gain (GWG) and postpartum weight retention (PPWR', 'Feasibility and acceptability', 'Median (Q1, Q3) helpfulness ratings', 'IOM weight gain recommendations']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517694', 'cui_str': '3.6'}]","[{'cui': 'C0920298', 'cui_str': 'Weight maintenance regimen'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0870196', 'cui_str': 'Behavioral health'}]","[{'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}, {'cui': 'C4704811', 'cui_str': 'Postpartum Weight Retention'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}]",26.0,0.147434,"At 37 weeks gestation, 77% of participants achieved IOM weight gain recommendations compared to 54% in the comparison group.
","[{'ForeName': 'J W', 'Initials': 'JW', 'LastName': 'Coughlin', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences Johns Hopkins University School of Medicine Baltimore MD USA.'}, {'ForeName': 'L M', 'Initials': 'LM', 'LastName': 'Martin', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine Johns Hopkins University School of Medicine Baltimore MD USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Henderson', 'Affiliation': 'Department of Obstetrics and Gynecology Johns Hopkins University School of Medicine Baltimore MD USA.'}, {'ForeName': 'A T', 'Initials': 'AT', 'LastName': 'Dalcin', 'Affiliation': 'Welch Center for Prevention, Epidemiology and Clinical Research Johns Hopkins University Baltimore MD USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Fountain', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine Johns Hopkins University School of Medicine Baltimore MD USA.'}, {'ForeName': 'N-Y', 'Initials': 'NY', 'LastName': 'Wang', 'Affiliation': 'Welch Center for Prevention, Epidemiology and Clinical Research Johns Hopkins University Baltimore MD USA.'}, {'ForeName': 'L J', 'Initials': 'LJ', 'LastName': 'Appel', 'Affiliation': 'Welch Center for Prevention, Epidemiology and Clinical Research Johns Hopkins University Baltimore MD USA.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Clark', 'Affiliation': 'Welch Center for Prevention, Epidemiology and Clinical Research Johns Hopkins University Baltimore MD USA.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Bennett', 'Affiliation': 'Welch Center for Prevention, Epidemiology and Clinical Research Johns Hopkins University Baltimore MD USA.'}]",Obesity science & practice,['10.1002/osp4.438']
1984,33082991,Parents lose less weight than nonparents in an intensive lifestyle intervention.,"Objective


Understand whether parents lose less weight than nonparents in behavioural weight interventions.
Methods


The Look AHEAD (Action for Health in Diabetes) trial randomized adults with Type 2 diabetes and overweight to an intensive lifestyle intervention (ILI) or control (diabetes support and education [DSE]). Participants who reported living with a child under age 18 were designated as 'parents' for this analysis. Intention to treat analysis was performed of the effect of the ILI on change in weight at 1 year by parental status. Adherence to attending intervention visits was compared between parents and nonparents. Subgroup analyses were done based on previous subgroup findings in the Look AHEAD study.
Results


Among 4,547 participants, 15% were parents. Parents were younger and more likely to have self-identified as African American or Hispanic/Latino. Comparing ILI with DSE, parents lost less weight than nonparents (-7.1% vs. -8.3%,  p  = 0.021). African American female parents lost 4% body weight compared with 7% in African American female nonparents ( p  = 0.01).
Conclusions


In a randomized trial, parents lost less weight than nonparents, and this difference was largest for African American women. These findings suggest parents face unique challenges achieving weight loss; more research is needed to understand and optimize interventions for parents.",2020,"In a randomized trial, parents lost less weight than nonparents, and this difference was largest for African American women.","[""Participants who reported living with a child under age 18 were designated as 'parents' for this analysis"", 'Diabetes) trial randomized adults with Type 2 diabetes and overweight to an', 'African American female parents', 'African American women', '4,547 participants, 15% were parents']",['intensive lifestyle intervention (ILI) or control (diabetes support and education [DSE'],['body weight'],"[{'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}]",4547.0,0.0548091,"In a randomized trial, parents lost less weight than nonparents, and this difference was largest for African American women.","[{'ForeName': 'Carolyn T', 'Initials': 'CT', 'LastName': 'Bramante', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine University of Minnesota Minneapolis Minnesota USA.'}, {'ForeName': 'Rachel L J', 'Initials': 'RLJ', 'LastName': 'Thornton', 'Affiliation': 'Division of General Pediatrics and Adolescent Medicine, Department of Pediatrics Johns Hopkins School of Medicine Baltimore Maryland USA.'}, {'ForeName': 'Scott J', 'Initials': 'SJ', 'LastName': 'Pilla', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine Johns Hopkins University School of Medicine Baltimore Maryland USA.'}, {'ForeName': 'Nisa M', 'Initials': 'NM', 'LastName': 'Maruthur', 'Affiliation': 'Welch Center for Prevention, Epidemiology, and Clinical Research Johns Hopkins Medical Institutions Baltimore Maryland USA.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Venkataramani', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine Johns Hopkins University School of Medicine Baltimore Maryland USA.'}, {'ForeName': 'Jeanne M', 'Initials': 'JM', 'LastName': 'Clark', 'Affiliation': 'Welch Center for Prevention, Epidemiology, and Clinical Research Johns Hopkins Medical Institutions Baltimore Maryland USA.'}]",Obesity science & practice,['10.1002/osp4.436']
1985,33083000,Protocol for a randomised controlled feasibility trial of exercise rehabilitation for people with postural tachycardia syndrome: the PULSE study.,"Background


Postural orthostatic tachycardia syndrome (POTS) is an autonomic nervous system disorder causing an abnormal cardiovascular response to upright posture. It affects around 0.2% of the population, most commonly women aged 13 to 50 years. POTS can be debilitating; prolonged episodes of pre-syncope and fatigue can severely affect activities of daily living and health-related quality of life (HRQoL). Medical treatment is limited and not supported by randomised controlled trial (RCT) evidence. Lifestyle interventions are first-line treatment, including increased fluid and salt intake, compression tights and isometric counter-pressure manoeuvres to prevent fainting. Observational studies and small RCTs suggest exercise training may improve symptoms and HRQoL in POTS, but evidence quality is low.
Methods


Sixty-two people (aged 18-40 years) with a confirmed diagnosis of POTS will be invited to enrol on a feasibility RCT with embedded qualitative study. The primary outcome will be feasibility; process-related measures will include the number of people eligible, recruited, randomised and withdrawn, along with indicators of exercise programme adherence and acceptability. Secondary physiological, clinical and health-related outcomes including sub-maximal recumbent bike exercise test, active stand test and HRQoL will be measured at 4 and 7 months post-randomisation by researchers blinded to treatment allocation. The PostUraL tachycardia Syndrome Exercise (PULSE) intervention consists of (1) individual assessment; (2) 12-week, once to twice-weekly, supervised out-patient exercise training; (3) behavioural and motivational support; and (4) guided lifestyle physical activity. The control intervention will be best-practice usual care with a single 30-min, one-to-one practitioner appointment, and general advice on safe and effective physical activity. For the embedded qualitative study, participants ( n  = 10 intervention,  n  = 10 control) will be interviewed at baseline and 4 months post-randomisation to assess acceptability and the feasibility of progressing to a definitive trial.
Discussion


There is very little high-quality research investigating exercise rehabilitation for people with POTS. The PULSE study will be the first randomised trial to assess the feasibility of conducting a definitive multicentre RCT testing supervised exercise rehabilitation with behavioural and motivational support, compared to best-practice usual care, for people with POTS.
Trial registration


ISRCTN45323485 registered on 7 April 2020.",2020,"The PULSE study will be the first randomised trial to assess the feasibility of conducting a definitive multicentre RCT testing supervised exercise rehabilitation with behavioural and motivational support, compared to best-practice usual care, for people with POTS.
","['Methods\n\n\nSixty-two people (aged 18-40\u2009years) with a confirmed diagnosis of POTS will be invited to enrol on a feasibility RCT with embedded qualitative study', 'people with POTS', 'people with postural tachycardia syndrome']","['exercise rehabilitation', 'PostUraL tachycardia Syndrome Exercise (PULSE) intervention consists of (1) individual assessment', 'supervised out-patient exercise training', 'exercise training']","['feasibility; process-related measures will include the number of people eligible, recruited, randomised and withdrawn, along with indicators of exercise programme adherence and acceptability', 'activities of daily living and health-related quality of life (HRQoL', 'Secondary physiological, clinical and health-related outcomes including sub-maximal recumbent bike exercise test, active stand test and HRQoL']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4517835', 'cui_str': '62'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1299624', 'cui_str': 'Postural orthostatic tachycardia syndrome'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0949415', 'cui_str': 'Qualitative Research'}]","[{'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C1299624', 'cui_str': 'Postural orthostatic tachycardia syndrome'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0444334', 'cui_str': 'Recumbent body position'}, {'cui': 'C0005375', 'cui_str': 'Bicycle'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",,0.160747,"The PULSE study will be the first randomised trial to assess the feasibility of conducting a definitive multicentre RCT testing supervised exercise rehabilitation with behavioural and motivational support, compared to best-practice usual care, for people with POTS.
","[{'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'McGregor', 'Affiliation': 'Department of Cardiopulmonary Rehabilitation, Centre for Exercise & Health, University Hospitals Coventry & Warwickshire NHS Trust, Watch Close, Coventry, CV1 3LN UK.'}, {'ForeName': 'Siew Wan', 'Initials': 'SW', 'LastName': 'Hee', 'Affiliation': 'Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Eftekhari', 'Affiliation': 'Department of Cardiology, University Hospitals Coventry & Warwickshire NHS Trust, Coventry, UK.'}, {'ForeName': 'Nikki', 'Initials': 'N', 'LastName': 'Holliday', 'Affiliation': 'Centre for Sport, Exercise and Life Sciences, Coventry University, Coventry, UK.'}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Pearce', 'Affiliation': 'Centre for Sport, Exercise and Life Sciences, Coventry University, Coventry, UK.'}, {'ForeName': 'Harbinder', 'Initials': 'H', 'LastName': 'Sandhu', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Simmonds', 'Affiliation': 'UCL Great Ormond Street Institute of Child Health, Faculty of Population Health, University College London, London, UK.'}, {'ForeName': 'Shivam', 'Initials': 'S', 'LastName': 'Joshi', 'Affiliation': 'Research & Development, University Hospitals Coventry & Warwickshire NHS Trust, Coventry, UK.'}, {'ForeName': 'Lesley', 'Initials': 'L', 'LastName': 'Kavi', 'Affiliation': 'POTS UK, Birmingham, UK.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Bruce', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Sandeep', 'Initials': 'S', 'LastName': 'Panikker', 'Affiliation': 'Department of Cardiology, University Hospitals Coventry & Warwickshire NHS Trust, Coventry, UK.'}, {'ForeName': 'Boon', 'Initials': 'B', 'LastName': 'Lim', 'Affiliation': 'Department of Cardiology, Imperial College Healthcare NHS Trust, London, UK.'}, {'ForeName': 'Sajad', 'Initials': 'S', 'LastName': 'Hayat', 'Affiliation': 'Department of Cardiology, Hamad Medical Corporation, Doha, Qatar.'}]",Pilot and feasibility studies,['10.1186/s40814-020-00702-1']
1986,33083014,The influence of common polygenic risk and gene sets on social skills group training response in autism spectrum disorder.,"Social skills group training (SSGT) is a frequently used behavioral intervention in autism spectrum disorder (ASD), but the effects are moderate and heterogeneous. Here, we analyzed the effect of polygenic risk score (PRS) and common variants in gene sets on the intervention outcome. Participants from the largest randomized clinical trial of SSGT in ASD to date were selected ( N  = 188, 99 from SSGT, 89 from standard care) to calculate association between the outcomes in the SSGT trial and PRSs for ASD, attention-deficit hyperactivity disorder (ADHD), and educational attainment. In addition, specific gene sets were selected to evaluate their role on intervention outcomes. Among all participants in the trial, higher PRS for ADHD was associated with significant improvement in the outcome measure, the parental-rated Social Responsiveness Scale. The significant association was due to better outcomes in the standard care group for individuals with higher PRS for ADHD (post-intervention:  β  = -4.747,  P  = 0.0129; follow-up:  β  = -5.309,  P  = 0.0083). However, when contrasting the SSGT and standard care group, an inferior outcome in the SSGT group was associated with higher ADHD PRS at follow-up ( β  = 6.67,  P  = 0.016). Five gene sets within the synaptic category showed a nominal association with reduced response to interventions. We provide preliminary evidence that genetic liability calculated from common variants could influence the intervention outcomes. In the future, larger cohorts should be used to investigate how genetic contribution affects individual response to ASD interventions.",2020,"The significant association was due to better outcomes in the standard care group for individuals with higher PRS for ADHD (post-intervention:  β  = -4.747,  P  = 0.0129; follow-up:  β  = -5.309,  P  = 0.0083).","['autism spectrum disorder (ASD', 'autism spectrum disorder']","['Social skills group training (SSGT', 'SSGT']","['polygenic risk score (PRS', 'parental-rated Social Responsiveness Scale', 'higher ADHD PRS']","[{'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}]","[{'cui': 'C0679005', 'cui_str': 'Social Abilities'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}]",,0.0392016,"The significant association was due to better outcomes in the standard care group for individuals with higher PRS for ADHD (post-intervention:  β  = -4.747,  P  = 0.0129; follow-up:  β  = -5.309,  P  = 0.0083).","[{'ForeName': 'Danyang', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': ""Center of Neurodevelopmental Disorders (KIND), Centre for Psychiatry Research, Department of Women's and Children's Health, Karolinska Institutet, Stockholm County Council, Stockholm, Sweden.""}, {'ForeName': 'Nora', 'Initials': 'N', 'LastName': 'Choque-Olsson', 'Affiliation': ""Center of Neurodevelopmental Disorders (KIND), Centre for Psychiatry Research, Department of Women's and Children's Health, Karolinska Institutet, Stockholm County Council, Stockholm, Sweden.""}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Jiao', 'Affiliation': 'Department of Biosciences and Nutrition, Karolinska Institutet, and Clinical Research Centre, Karolinska University Hospital, Huddinge, Sweden.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Norgren', 'Affiliation': 'Department of Molecular Biology, National Bioinformatics Infrastructure Sweden (NBIS), Science for Life Laboratory, Umeå University, 901 87 Umeå, Sweden.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Jonsson', 'Affiliation': ""Center of Neurodevelopmental Disorders (KIND), Centre for Psychiatry Research, Department of Women's and Children's Health, Karolinska Institutet, Stockholm County Council, Stockholm, Sweden.""}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Bölte', 'Affiliation': ""Center of Neurodevelopmental Disorders (KIND), Centre for Psychiatry Research, Department of Women's and Children's Health, Karolinska Institutet, Stockholm County Council, Stockholm, Sweden.""}, {'ForeName': 'Kristiina', 'Initials': 'K', 'LastName': 'Tammimies', 'Affiliation': ""Center of Neurodevelopmental Disorders (KIND), Centre for Psychiatry Research, Department of Women's and Children's Health, Karolinska Institutet, Stockholm County Council, Stockholm, Sweden.""}]",NPJ genomic medicine,['10.1038/s41525-020-00152-x']
1987,33083247,Efficacy and Safety of All-oral Emitasvir and Sofosbuvir in Patients with Genotype 1b HCV Infections without Cirrhosis.,"Background and Aims:  Emitasvir is a new type of hepatitis C virus (HCV) nonstructural protein 5A (NS5A) inhibitor, and the data of phase 2 trial has shown emitasvir-sofosbuvir to have good safety and tolerance. We conducted this phase 3 trial to further verify the efficacy and safety.  Methods:  We evaluated the antiviral activity and safety of a 12-week regimen of emitasvir phosphate (100 mg) combined with sofosbuvir (400 mg) once daily in non-cirrhotic patients with genotype 1 HCV infection. The primary endpoint was a sustained virological response at 12 weeks (SVR12) after the end of treatment.  Results:  Of the 362 patients enrolled in the trial, 39.8% were male, 99.2% had HCV genotype 1b, 0.8% had genotype 1a and 79.8% were treatment-naïve. The average age was 47.2 years. All patients completed the treatment and follow-up. All 3 patients with genotype 1a achieved SVR. Two genotype 1b treatment-naïve patients experienced virologic relapse. The rate of SVR12 was 99.7% (358/359), and SVR24 was 99.4% (357/359) in genotype 1b. Overall, 36.2% had resistance-associated substitutions (RASs) in NS5A and 98.3% had RASs in NS5B at baseline. The RASs at baseline had no effect on the rates of response. Serious adverse events were reported in 16 patients and were not related to emitasvir-sofosbuvir. Most adverse events did not require therapy.  Conclusions:  The 12 weeks of treatment with emitasvir-sofosbuvir was a highly efficient and safe treatment for a wide range of patients with HCV genotype 1b infection without cirrhosis, who had not been treated or who had been treated with interferon-based regimen previously.",2020,"The rate of SVR12 was 99.7% (358/359), and SVR24 was 99.4% (357/359) in genotype 1b.","['362 patients enrolled in the trial, 39.8% were male, 99.2% had HCV genotype 1b, 0.8% had genotype 1a and 79.8% were treatment-naïve', 'patients with HCV genotype 1b infection without cirrhosis, who had not been treated or who had been treated with interferon-based regimen previously', 'Patients with Genotype 1b HCV Infections without Cirrhosis', 'non-cirrhotic patients with genotype 1 HCV infection']","['All-oral Emitasvir and Sofosbuvir', 'emitasvir phosphate (100 mg) combined with sofosbuvir', 'emitasvir-sofosbuvir']","['rates of response', 'efficacy and safety', 'sustained virological response', 'Serious adverse events', 'Efficacy and Safety', 'SVR24', 'resistance-associated substitutions (RASs', 'virologic relapse', 'antiviral activity and safety', 'SVR', 'rate of SVR12']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1533728', 'cui_str': 'Hepatitis C virus genotype determination'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0019196', 'cui_str': 'Viral hepatitis C'}, {'cui': 'C0439687', 'cui_str': 'Non-cirrhotic'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C2976303', 'cui_str': 'sofosbuvir'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0205466', 'cui_str': 'Virologic'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0003451', 'cui_str': 'Antiviral'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1258192', 'cui_str': 'Systemic vascular resistance'}]",3.0,0.0558653,"The rate of SVR12 was 99.7% (358/359), and SVR24 was 99.4% (357/359) in genotype 1b.","[{'ForeName': 'Huiying', 'Initials': 'H', 'LastName': 'Rao', 'Affiliation': ""Peking University People's Hospital, Peking University Hepatology Institute, National Clinical Research Center for Infectious Disease, Beijing Key Laboratory of Hepatitis C and Immunotherapy for Liver Diseases, Beijing International Cooperation Base for Science and Technology on NAFLD Diagnosis, Beijing, China.""}, {'ForeName': 'Xingxiang', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': ""Department of Infectious Diseases, Sichuan Provincial People's Hospital, Chengdu, Sichuan, China.""}, {'ForeName': 'Youwen', 'Initials': 'Y', 'LastName': 'Tan', 'Affiliation': ""Department of Hepatology, The Third People's Hospital of Zhenjiang, Zhenjiang, Jiangsu, China.""}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Ning', 'Affiliation': 'Department of Infectious Diseases, Tongji Hospital, Tongji Medical College Huazhong University of Science and Technology, Wuhan, Hubei, China.'}, {'ForeName': 'Daokun', 'Initials': 'D', 'LastName': 'Yang', 'Affiliation': 'Department of Infectious Diseases, The First Affiliated Hospital of Xinxiang Medical College, Xinxiang, Henan, China.'}, {'ForeName': 'Jiefei', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Shanghai Public Health Clinical Center, Shanghai, China.'}, {'ForeName': 'Yongfeng', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Hepatology, The Second Hospital of Nanjing, Nanjing, Jiangsu, China.'}, {'ForeName': 'Sujun', 'Initials': 'S', 'LastName': 'Zheng', 'Affiliation': 'Center of Artificial liver, Beijing Youan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Dongliang', 'Initials': 'D', 'LastName': 'Yang', 'Affiliation': 'Department of Infectious Disease, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China.'}, {'ForeName': 'Jinlin', 'Initials': 'J', 'LastName': 'Hou', 'Affiliation': 'Department of Infectious Diseases, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Xie', 'Affiliation': 'Department of Infectious Diseases, Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Caiyan', 'Initials': 'C', 'LastName': 'Zhao', 'Affiliation': 'Department of Infectious Diseases, The Third Hospital of Hebei Medical University, Shijiazhuang, Hebei, China.'}, {'ForeName': 'Lunli', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Infectious Diseases, The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China.'}, {'ForeName': 'Xiaorong', 'Initials': 'X', 'LastName': 'Mao', 'Affiliation': 'Department of Infectious Diseases, The First Hospital of Lanzhou University, Lanzhou, Gansu, China.'}, {'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Sun', 'Affiliation': ""Department of Infectious Diseases, Wuxi Fifth People's Hospital, Wuxi, Jiangsu, China.""}, {'ForeName': 'Lang', 'Initials': 'L', 'LastName': 'Bai', 'Affiliation': 'Infectious Diseases Center, West China Hospital, Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'Fuchun', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': ""Department of Hepatology, Guangzhou Eighth People's Hospital, Guangzhou, Guangdong, China.""}, {'ForeName': 'Jinglan', 'Initials': 'J', 'LastName': 'Jin', 'Affiliation': 'Department of Hepato-Biliary-Pancreatic Diseases, The First Hospital of Jilin University, Changchun, Jilin, China.'}, {'ForeName': 'Yingren', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': ""Department of Infectious Diseases, Xi'an Jiaotong University First Affiliated Hospital, Xi'an, Shaanxi, China.""}, {'ForeName': 'Maorong', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': ""Department of Infectious Diseases, DiBaYi Hospital of the Chinese People's Liberation Army, Nanjing, Jiangsu, China.""}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Xie', 'Affiliation': 'Hepatology Center, Beijing Ditan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yingjie', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': ""Department of Infectious Diseases, Zhengzhou People's Hospital, Zhengzhou, Henan, China.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Quan', 'Affiliation': 'Department of Infectious Diseases, Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Xuebing', 'Initials': 'X', 'LastName': 'Yan', 'Affiliation': 'Department of Infectious Diseases, Xuzhou Medical College Affiliated Hospital, Xuzhou, Jiangsu, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'An', 'Affiliation': ""Department of Infectious Diseases, Shenyang Sixth People's Hospital, Shenyang, Liaoning, China.""}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Lin', 'Affiliation': 'Department of Infectious Diseases, Hainan General Hospital, Haikou, Hainan, China.'}, {'ForeName': 'Jidong', 'Initials': 'J', 'LastName': 'Jia', 'Affiliation': 'Hepatology Center, Beijing Friendship Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Xiaoxuan', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': ""Department of Infectious Diseases, Hunan Provincial People's Hospital, Changsha, Hunan, China.""}, {'ForeName': 'Zuojiong', 'Initials': 'Z', 'LastName': 'Gong', 'Affiliation': 'Department of Infectious Diseases, Renmin Hospital of Wuhan University, Wuhan, Hubei, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Infectious Diseases, Wuhan central hospital, Wuhan, Hubei, China.'}, {'ForeName': 'Yongping', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Infectious Diseases, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China.'}, {'ForeName': 'Zhansheng', 'Initials': 'Z', 'LastName': 'Jia', 'Affiliation': ""Department of Infectious Diseases, Tangdu Hospital, The Fourth Military Medical University of the People's Liberation Army, Xi'an, Shaanxi, China.""}, {'ForeName': 'Minghua', 'Initials': 'M', 'LastName': 'Lin', 'Affiliation': 'Department of Hepatology, Meng Chao Hepatobiliary Hospital, Fujian Medical University, Fuzhou, Fujian, China.'}, {'ForeName': 'Guiqiang', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'Department of Infectious Diseases, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Yueyong', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Department of Infectious Diseases, The First Affiliated Hospital of Fujian Medical University, Fuzhou, Fujian, China.'}, {'ForeName': 'Yingjun', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'State Key Laboratory of Anti-Infective Drug Development (NO.2015DQ780357), Sunshine Lake Pharma Co., Ltd, Dongguan, Guangdong, China.'}, {'ForeName': 'Hongming', 'Initials': 'H', 'LastName': 'Xie', 'Affiliation': 'State Key Laboratory of Anti-Infective Drug Development (NO.2015DQ780357), Sunshine Lake Pharma Co., Ltd, Dongguan, Guangdong, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Luo', 'Affiliation': 'State Key Laboratory of Anti-Infective Drug Development (NO.2015DQ780357), Sunshine Lake Pharma Co., Ltd, Dongguan, Guangdong, China.'}, {'ForeName': 'Qingyun', 'Initials': 'Q', 'LastName': 'Ren', 'Affiliation': 'State Key Laboratory of Anti-Infective Drug Development (NO.2015DQ780357), Sunshine Lake Pharma Co., Ltd, Dongguan, Guangdong, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Huang', 'Affiliation': ""Peking University People's Hospital, Peking University Hepatology Institute, National Clinical Research Center for Infectious Disease, Beijing Key Laboratory of Hepatitis C and Immunotherapy for Liver Diseases, Beijing International Cooperation Base for Science and Technology on NAFLD Diagnosis, Beijing, China.""}, {'ForeName': 'Lai', 'Initials': 'L', 'LastName': 'Wei', 'Affiliation': 'Hepatopancreatobiliary Center, Beijing Tsinghua Changgung Hospital, Tsinghua University, Beijing, China.'}]",Journal of clinical and translational hepatology,['10.14218/JCTH.2020.00031']
1988,33083250,Histological Outcome of Fuzheng Huayu plus Entecavir Combination Therapy in Chronic Hepatitis B Patients with Significant Liver Fibrosis.,"Background and Aims:  To evaluate the efficacy of Fuzheng Huayu (FZHY), a Chinese herbal formula, plus entecavir (ETV) in regression of liver fibrosis in chronic hepatitis B (CHB) patients with significant fibrosis/cirrhosis.  Methods:  The current study was a two-center, randomized, double-blind and placebo-controlled pilot study. Fifty-two currently untreated chronic hepatitis B patients with Ishak fibrosis score ≥3 points were identified and 1:1 randomized into FZHY plus ETV combination and placebo plus ETV groups. The second liver biopsy was performed after 48-week treatment. Necroinflammatory improvement and regression of fibrosis were assessed. Fine changes in different collagen features in paired liver biopsies were evaluated by dual-photon microscopy for both groups.  Results:  Forty-nine patients completed the full course of treatment; forty-six of them underwent second liver biopsy (for which twenty-two were in the combination group and twenty-four were in the control group). Compared to those in the control group, patients in the combination group had significantly higher rate of fibrosis regression (82% vs. 54%) ( p <0.05). Furthermore, the necroinflammatory improvement was greater in the combination group than in the control group (59% vs. 25%,  p <0.05). Among the more than 80 collagen parameters in the dual-photon analysis, 5 decreased significantly in the combination group compared to the control group ( p <0.05). However, no significant improvement was detected in either biochemical, virologic or serologic responses between these two groups at week 48.  Conclusions:  The combination therapy of FZHY plus ETV for 48 weeks resulted in a higher rate of necroinflammatory improvement and fibrosis regression than ETV alone in chronic hepatitis B patients with significant fibrosis/cirrhosis. The clinical trial number is ChiCTR-TRC-11001377.",2020,"However, no significant improvement was detected in either biochemical, virologic or serologic responses between these two groups at week 48.  ","['chronic hepatitis B (CHB) patients with significant fibrosis/cirrhosis', 'Forty-nine patients completed the full course of treatment; forty-six of them underwent second liver biopsy (for which twenty-two were in the combination group and twenty-four were in the control group', 'Fifty-two currently untreated chronic hepatitis B patients with Ishak fibrosis score ≥3 points', 'Chronic Hepatitis B Patients with Significant Liver Fibrosis', 'chronic hepatitis B patients with significant fibrosis/cirrhosis']","['Fuzheng Huayu plus Entecavir Combination Therapy', 'FZHY plus ETV combination and placebo plus ETV', 'placebo', 'FZHY plus ETV', 'Fuzheng Huayu (FZHY), a Chinese herbal formula, plus entecavir (ETV']","['rate of necroinflammatory improvement and fibrosis regression', 'dual-photon analysis', 'necroinflammatory improvement', 'Necroinflammatory improvement and regression of fibrosis', 'biochemical, virologic or serologic responses', 'rate of fibrosis regression']","[{'cui': 'C0524909', 'cui_str': 'Chronic type B viral hepatitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0193388', 'cui_str': 'Biopsy of liver'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4319570', 'cui_str': '52'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0239946', 'cui_str': 'Hepatic fibrosis'}]","[{'cui': 'C2607355', 'cui_str': 'fuzheng huayu'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0971023', 'cui_str': 'entecavir'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0376667', 'cui_str': 'Herbals'}]","[{'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0684321', 'cui_str': 'Regression - mental defense mechanism'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0086805', 'cui_str': 'Photon'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0205466', 'cui_str': 'Virologic'}, {'cui': 'C0205473', 'cui_str': 'Serologic'}]",52.0,0.0570258,"However, no significant improvement was detected in either biochemical, virologic or serologic responses between these two groups at week 48.  ","[{'ForeName': 'Hong-Lian', 'Initials': 'HL', 'LastName': 'Gui', 'Affiliation': 'Department of Infectious Diseases, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Chang-Qing', 'Initials': 'CQ', 'LastName': 'Zhao', 'Affiliation': 'Department of Liver Cirrhosis, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Infectious Diseases, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Hong-Tu', 'Initials': 'HT', 'LastName': 'Gu', 'Affiliation': 'Department of Liver Cirrhosis, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Wei-Jing', 'Initials': 'WJ', 'LastName': 'Wang', 'Affiliation': 'Department of Infectious Diseases, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Cai', 'Affiliation': 'Department of Infectious Diseases, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Guo', 'Affiliation': 'Department of Infectious Diseases, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Shi-San', 'Initials': 'SS', 'LastName': 'Bao', 'Affiliation': 'Discipline of Pathology, School of Medicine Sciences and Bosch Institute, Charles Perkin Centre, University of Sydney, New South Wales, Australia.'}, {'ForeName': 'Lie-Ming', 'Initials': 'LM', 'LastName': 'Xu', 'Affiliation': 'Department of Liver Cirrhosis, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Xie', 'Affiliation': 'Department of Infectious Diseases, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}]",Journal of clinical and translational hepatology,['10.14218/JCTH.2020.00004']
1989,33083284,Real-World Efficacy and Safety of Lenvatinib in Korean Patients with Advanced Hepatocellular Carcinoma: A Multicenter Retrospective Analysis.,"Introduction/Objective


Lenvatinib demonstrated efficacy and safety in patients with advanced hepatocellular carcinoma (HCC) in the randomized phase III REFLECT trial. Considering the discrepancies in patients between clinical trial data and daily practice, an account of practical experience is needed.
Methods


We conducted a multicenter retrospective analysis in which 3 tertiary referral centers participated. A total of 92 patients with advanced HCC treated with lenvatinib between September 2018 and January 2020 were analyzed.
Results


Lenvatinib was used as the first-line therapy for 67 (72.8%) patients, and for 25 (27.2%) patients previously treated with other systemic therapy including immune checkpoint inhibitors. At the time of initiation of lenvatinib, 74 (80.4%) and 18 (19.6%) patients were classified as Child-Pugh A and B, respectively. Thirty-five patients (38.0%) had extensive disease that would have excluded them from the REFLECT trial. In the Child-Pugh A group, the response rate graded according to the Response Evaluation Criteria in Solid Tumors v1.1 was 21.1%, median progression-free survival (PFS) was 4.6 (95% confidence interval [CI] 3.1-6.1) months, and overall survival (OS) was 10.7 (95% CI 4.8-16.5) months for patients treated with first-line lenvatinib ( n  = 57). With second- or later-line lenvatinib ( n  = 17), median PFS and OS were 4.1 (95% CI 3.1-5.1) and 6.4 (95% CI 5.1-7.7) months, respectively. In the Child-Pugh B group ( n  = 18), median PFS and OS were 2.6 (95% CI 0.6-4.6) and 5.3 (95% CI 2.0-8.5) months, respectively. The most common grade 3-4 toxicities were hyperbilirubinemia ( n  = 8; 8.7%), AST elevation ( n  = 6; 6.5%), and diarrhea ( n  = 5; 5.4%) across all study patients.
Conclusions


In this real-world study, lenvatinib was found to be well tolerated and effective in more heterogeneous HCC patient populations.",2020,"The most common grade 3-4 toxicities were hyperbilirubinemia ( n  = 8; 8.7%), AST elevation ( n  = 6; 6.5%), and diarrhea ( n  = 5; 5.4%) across all study patients.
","['92 patients with advanced HCC treated with lenvatinib between September 2018 and January 2020 were analyzed', '3 tertiary referral centers participated', 'patients with advanced hepatocellular carcinoma (HCC', 'Korean Patients with Advanced Hepatocellular Carcinoma', 'Thirty-five patients (38.0%) had extensive disease']",['Lenvatinib'],"['diarrhea', 'overall survival (OS', 'median progression-free survival (PFS', 'median PFS and OS', 'efficacy and safety', 'tolerated and effective', 'AST elevation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C2986924', 'cui_str': 'lenvatinib'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0849867', 'cui_str': 'Generalized illness'}]","[{'cui': 'C2986924', 'cui_str': 'lenvatinib'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}]",92.0,0.149026,"The most common grade 3-4 toxicities were hyperbilirubinemia ( n  = 8; 8.7%), AST elevation ( n  = 6; 6.5%), and diarrhea ( n  = 5; 5.4%) across all study patients.
","[{'ForeName': 'Jaekyung', 'Initials': 'J', 'LastName': 'Cheon', 'Affiliation': 'Department of Internal Medicine, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, Republic of Korea.'}, {'ForeName': 'Hong Jae', 'Initials': 'HJ', 'LastName': 'Chon', 'Affiliation': 'Departments of Medical Oncology, CHA Bundang Medical Center, CHA University School of Medicine, Seongnam, Republic of Korea.'}, {'ForeName': 'Yeonghak', 'Initials': 'Y', 'LastName': 'Bang', 'Affiliation': 'Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Neung Hwa', 'Initials': 'NH', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, Republic of Korea.'}, {'ForeName': 'Jung Woo', 'Initials': 'JW', 'LastName': 'Shin', 'Affiliation': 'Department of Internal Medicine, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, Republic of Korea.'}, {'ForeName': 'Kang Mo', 'Initials': 'KM', 'LastName': 'Kim', 'Affiliation': 'Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Han Chu', 'Initials': 'HC', 'LastName': 'Lee', 'Affiliation': 'Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jooho', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Departments of Gastroenterology and Hepatology, CHA Bundang Medical Center, CHA University School of Medicine, Seongnam, Republic of Korea.'}, {'ForeName': 'Changhoon', 'Initials': 'C', 'LastName': 'Yoo', 'Affiliation': 'Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Baek-Yeol', 'Initials': 'BY', 'LastName': 'Ryoo', 'Affiliation': 'Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}]",Liver cancer,['10.1159/000508901']
1990,33083289,Effect of Perceptual Stress Reduction Control Intervention on the Level of Symptoms in Breast Cancer at Different Time Points.,"Background


To investigate the effect of perceptual stress reduction control intervention on the level of symptomatic groups at different time points in breast cancer.
Methods


A total of 124 breast cancer patients were divided into intervention group and control group, 62 cases in each group. Perioperative nursing and chemotherapy nursing were given to the control group, and the intervention group was given the interventional stress reduction control intervention. The level of symptom clusters of different time points were compared between the two groups.
Results


The incidence and severity of myelosuppression in the intervention group were slightly lower than those in the control group. The adverse reactions of bone marrow suppression at T3 were much lower than those in the control group, and the differences were significant ( P =0.003,  P =0.043). The control group had higher incidence and more severe symptoms of nausea, vomiting and diarrhea than the intervention group ( P =0.002,  P =0.042). The symptoms of breast pain and swelling at T1 in the intervention group were significantly lower than those in the control group ( P =0.000,  P =0.000). There was no significant difference in breast symptoms between the two groups at T2 and T3 ( p >0.05). At the time of T2 and T3 of chemotherapy, the health promotion behavior scores of the intervention group were higher than the control group, and the difference was statistically significant (P T2 =0.000, P T3 =0.000).
Conclusion


Perceptual stress reduction control intervention can effectively relieve bone marrow suppression, digestive tract discomfort and breast symptoms, and promote health promotion behavior.",2020,"The symptoms of breast pain and swelling at T1 in the intervention group were significantly lower than those in the control group ( P =0.000,  P =0.000).",['124 breast cancer patients'],"['perceptual stress reduction control intervention', 'Perceptual Stress Reduction Control Intervention', 'interventional stress reduction control intervention', 'Conclusion\n\n\nPerceptual stress reduction control intervention']","['bone marrow suppression, digestive tract discomfort and breast symptoms', 'level of symptom clusters', 'severe symptoms of nausea, vomiting and diarrhea', 'adverse reactions of bone marrow suppression', 'Level of Symptoms in Breast Cancer', 'symptoms of breast pain and swelling at T1', 'incidence and severity of myelosuppression', 'health promotion behavior scores', 'breast symptoms']","[{'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0854467', 'cui_str': 'Myelosuppression'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0436345', 'cui_str': 'Symptom severe'}, {'cui': 'C0151791', 'cui_str': 'Nausea, vomiting and diarrhea'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0024902', 'cui_str': 'Pain of breast'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0517496', 'cui_str': 'Health promotion behavior'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",124.0,0.0150264,"The symptoms of breast pain and swelling at T1 in the intervention group were significantly lower than those in the control group ( P =0.000,  P =0.000).","[{'ForeName': 'Zhongru', 'Initials': 'Z', 'LastName': 'Cao', 'Affiliation': 'Department of Medical Oncology, Harbin Medical University Cancer Hospital, Harbin 150040, P.R. China.'}, {'ForeName': 'Yuting', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Ward IV, Department of Breast Surgery, Harbin Medical University Cancer Hospital, Harbin 150040, P.R. China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Medical Oncology, Harbin Medical University Cancer Hospital, Harbin 150040, P.R. China.'}, {'ForeName': 'Yanhua', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Medical Oncology, Harbin Medical University Cancer Hospital, Harbin 150040, P.R. China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Medical Oncology, Harbin Medical University Cancer Hospital, Harbin 150040, P.R. China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Ma', 'Affiliation': 'Department of Medical Oncology, Harbin Medical University Cancer Hospital, Harbin 150040, P.R. China.'}, {'ForeName': 'Yunfei', 'Initials': 'Y', 'LastName': 'An', 'Affiliation': 'Department of Medical Oncology, Harbin Medical University Cancer Hospital, Harbin 150040, P.R. China.'}, {'ForeName': 'Yibo', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Medical Oncology, Harbin Medical University Cancer Hospital, Harbin 150040, P.R. China.'}, {'ForeName': 'Huiyan', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Nursing Department, Harbin Medical University Cancer Hospital, Harbin 150040, P.R. China.'}]",Iranian journal of public health,['10.18502/ijph.v49i7.3576']
1991,31512572,Obesity is associated with folate metabolism.,"Objective : The aim of the present study is to perform a systemic review of the previous studies executed on the association between obesity and folate.  Method : In the present research, the selected keywords were scanned on the PubMed, Web of Science, Cochrane and Lilac databases between May and June, 2017 through Gazi University's network. In total, 4236 clinical, randomized controlled, cross-sectional and prospective studies were determined and 17 of these that specifically fit the aims of the present research were reviewed. This study involved an electronic literature search of databases on folic acid and obesity published in the English language between 2000 and 2016.  Results : Of the 17 studies, 5 were based on folic acid supplementation and 12 were related with participants' folate status. As a general consequence of both intake and serum/status measurements of folic acid supplementation: It was found that obesity-associated metabolic changes might affect individual folate use and obese individuals had lower serum folate levels, although there was no change in folate intake.  Conclusion : Overweight and obese individuals have lower serum folate concentrations when compared with individuals with normal weight. It is explained by increased use of folic acid, urinary excretion, dilution of blood volume, different levels in different tissues and changes in the endocrine functions of folate. Individuals with higher Body Mass Indexes have less supplement use, unhealthier diets and donot consume sufficient vegetables and fruits, all of which can affect decrease in folate levels. Furthermore, adiposity may affect folate absorption by intestinal epithelium.",2020,"Individuals with higher Body Mass Indexes have less supplement use, unhealthier diets and donot consume sufficient vegetables and fruits, all of which can affect decrease in folate levels.","['Overweight and obese individuals', 'English language between 2000 and 2016']",['folic acid supplementation'],"['folate levels', 'serum folate concentrations', 'folic acid, urinary excretion, dilution of blood volume']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0470277', 'cui_str': '2000'}]","[{'cui': 'C0556110', 'cui_str': 'Folic acid supplement agent'}]","[{'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0079240', 'cui_str': 'Dilution'}, {'cui': 'C0005850', 'cui_str': 'Blood volume'}]",,0.0262196,"Individuals with higher Body Mass Indexes have less supplement use, unhealthier diets and donot consume sufficient vegetables and fruits, all of which can affect decrease in folate levels.","[{'ForeName': 'Süleyman', 'Initials': 'S', 'LastName': 'Köse', 'Affiliation': 'Gazi University, Faculty of Health Sciences, Department of Nutrition and Dietetics, 06560 Beşevler, Ankara, Turkey.'}, {'ForeName': 'Saniye', 'Initials': 'S', 'LastName': 'Sözlü', 'Affiliation': 'Gazi University, Faculty of Health Sciences, Department of Nutrition and Dietetics, 06560 Beşevler, Ankara, Turkey.'}, {'ForeName': 'Hatice', 'Initials': 'H', 'LastName': 'Bölükbaşi', 'Affiliation': 'Gazi University, Faculty of Health Sciences, Department of Nutrition and Dietetics, 06560 Beşevler, Ankara, Turkey.'}, {'ForeName': 'Nüket', 'Initials': 'N', 'LastName': 'Ünsal', 'Affiliation': 'Gazi University, Faculty of Health Sciences, Department of Nutrition and Dietetics, 06560 Beşevler, Ankara, Turkey.'}, {'ForeName': 'Makbule', 'Initials': 'M', 'LastName': 'Gezmen-Karadağ', 'Affiliation': 'Gazi University, Faculty of Health Sciences, Department of Nutrition and Dietetics, 06560 Beşevler, Ankara, Turkey.'}]",International journal for vitamin and nutrition research. Internationale Zeitschrift fur Vitamin- und Ernahrungsforschung. Journal international de vitaminologie et de nutrition,['10.1024/0300-9831/a000602']
1992,31534158,Visual dynamics cues in learning complex physical interactions.,"This study investigated the role of visual dynamics cues (VDCs) in learning to interact with a complex physical system. Manual gait training was used as an exemplary case, as it requires therapists to control the non-trivial locomotor dynamics of patients. A virtual analog was developed that allowed naïve subjects to manipulate the leg of a virtual stroke survivor (a virtual patient; VP) walking on a treadmill using a small robotic manipulandum. The task was to make the VP's leg pass through early, mid, and late swing gait targets. One group of subjects (n = 17) started practice seeing the VP's affected thigh and shank (i.e., VDCs); a second control group (n = 16) only saw the point-of-contact (VP ankle). It was hypothesized that, if seeing the VP's leg provides beneficial dynamics information, the VDC group would have better task performance and generalization than controls. Results were not supportive. Both groups had similar task performance, and for the late swing gait target, a decrement in manipulative accuracy was observed when VDCs were removed in a generalization task. This suggests that when learning to manipulate complex dynamics, VDCs can create a dependency that negatively affects generalization if the visual context is changed.",2019,"Both groups had similar task performance, and for the late swing gait target, a decrement in manipulative accuracy was observed when VDCs were removed in a generalization task.",[],"['Manual gait training', 'visual dynamics cues (VDCs']",['manipulative accuracy'],[],"[{'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0010439', 'cui_str': 'Cues'}]","[{'cui': 'C0947647', 'cui_str': 'Manipulation'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}]",,0.0142442,"Both groups had similar task performance, and for the late swing gait target, a decrement in manipulative accuracy was observed when VDCs were removed in a generalization task.","[{'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Hasson', 'Affiliation': 'Neuromotor Systems Laboratory, Northeastern University, Boston, MA, USA. c.hasson@northeastern.edu.'}, {'ForeName': 'Paneed F', 'Initials': 'PF', 'LastName': 'Jalili', 'Affiliation': 'Neuromotor Systems Laboratory, Northeastern University, Boston, MA, USA.'}]",Scientific reports,['10.1038/s41598-019-49637-5']
1993,31564356,Prospective evaluation of aflibercept in pigment epithelial detachments secondary to neovascular age related macular degeneration.,"OBJECTIVE


To assess the efficacy of intravitreal aflibercept in treating visual loss and structural changes in patients with pigment epithelial detachments (PED) secondary to neovascular age-related macular degeneration (nAMD).
METHODS


Prospective, exploratory, open-label study (ClinicalTrials.gov Identifier: NCT02142296). Participants with PED secondary to nAMD were enrolled and received intravitreal aflibercept injection on a monthly basis for 3 months, followed by injections on a bimonthly basis for another 9 months. Best-corrected visual acuity (BCVA), ophthalmic examinations, optical coherence tomography (OCT) imaging, and fluorescein angiography were performed based on a predetermined schedule.
RESULTS


Thirty-six participants (37 eyes) were enrolled. At the end of study, 74.3% eyes demonstrated PED height reduction of 25% or more and 34.3% demonstrated complete resolution. The average reduction in retinal thickness was 128.4 μm. Participant eyes who had at least a 25% reduction in PED height at month 4 were labelled as ""responders"" (73.0%, n = 27), and those who had less than 25% reduction in PED height were labelled as ""partial-responders"" (27.0%, n = 10). Responders demonstrated more significant reduction in PED height than partial-responders (p <0.0001). The average gain in BCVA was 10.1 Early Treatment Diabetic Retinopathy Study (ETDRS) letters. Responders demonstrated more gain in BCVA than partial-responders (p = 0.0018). Among the responders, 57.7% demonstrated disease recurrences with increase in PED height during bimonthly dosing.
CONCLUSIONS


Intravitreal aflibercept injection for patients with PEDs secondary to nAMD has high response rate with few adverse events. Responders demonstrated BCVA gains, as well as structural improvements. However, high recurrence rate was found on bimonthly maintenance dosing.",2019,Responders demonstrated more significant reduction in PED height than partial-responders (p <0.0001).,"['Participants with PED secondary to nAMD', 'pigment epithelial detachments secondary to neovascular age related macular degeneration', 'Thirty-six participants (37 eyes) were enrolled', 'patients with pigment epithelial detachments (PED) secondary to neovascular age-related macular degeneration (nAMD']","['intravitreal aflibercept injection', 'aflibercept', 'intravitreal aflibercept']","['Best-corrected visual acuity (BCVA), ophthalmic examinations, optical coherence tomography (OCT) imaging, and fluorescein angiography', 'average gain in BCVA', 'BCVA gains', 'retinal thickness', 'high recurrence rate', 'PED height reduction', 'disease recurrences', 'PED height', 'gain in BCVA']","[{'cui': 'C0339546', 'cui_str': 'Retinal pigment epithelial detachment'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}, {'cui': 'C0271084', 'cui_str': 'Exudative age-related macular degeneration'}, {'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C4050106', 'cui_str': 'aflibercept Injection'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0200149', 'cui_str': 'Ophthalmic examination and evaluation'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0016313', 'cui_str': 'Fluorescein angiography of eye'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0339546', 'cui_str': 'Retinal pigment epithelial detachment'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0679254', 'cui_str': 'Disease recurrence'}]",,0.0250675,Responders demonstrated more significant reduction in PED height than partial-responders (p <0.0001).,"[{'ForeName': 'Vlad', 'Initials': 'V', 'LastName': 'Diaconita', 'Affiliation': ""Ivey Eye Institute, St. Joseph's Health Care, London, Ont.""}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': ""Ivey Eye Institute, St. Joseph's Health Care, London, Ont.""}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Pal', 'Affiliation': ""Ivey Eye Institute, St. Joseph's Health Care, London, Ont.""}, {'ForeName': 'Faten', 'Initials': 'F', 'LastName': 'Bahnacy', 'Affiliation': ""Ivey Eye Institute, St. Joseph's Health Care, London, Ont.""}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Gonder', 'Affiliation': ""Ivey Eye Institute, St. Joseph's Health Care, London, Ont.. Electronic address: john.gonder@lhsc.on.ca.""}]",Canadian journal of ophthalmology. Journal canadien d'ophtalmologie,['10.1016/j.jcjo.2019.01.004']
1994,31633369,The correlations in experience principle: How culture shapes concepts of time and number.,"People use space to conceptualize abstract domains like time and number. This tendency may be a cognitive universal, but the specifics of people's implicit space-time and space-number associations vary across cultures. In Western cultures, both time and numbers are arranged in people's minds along an imaginary horizontal line, from left to right, but in other cultures the directions of the mental timeline (MTL) and mental number line (MNL) are reversed. How does culture shape our abstract concepts? Using time and number as a testbed, we propose and test a general principle, which we call the CORrelations in Experience (CORE) principle, according to which different aspects of experience should selectively affect different abstract concepts. Across 3 training experiments, the MTL was shaped by experiences that provide a correlation between space and time, whereas the MNL was shaped by experiences that provide a correlation between space and number. These findings reveal that the MTL and MNL have distinct experiential bases, supporting the CORE principle and challenging the widespread claim that both mappings are determined by a common set of cultural experiences (e.g., reading, writing, visual scanning). The CORE principle provides an account of how domains like time and number, universal fixtures of the natural world, can be conceptualized in culture-specific ways: People spatialize abstract domains in their minds according to the ways those domains are spatialized in their experience. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"Across 3 training experiments, the MTL was shaped by experiences that provide a correlation between space and time, whereas the MNL was shaped by experiences that provide a correlation between space and number.",[],[],[],[],[],[],,0.0319342,"Across 3 training experiments, the MTL was shaped by experiences that provide a correlation between space and time, whereas the MNL was shaped by experiences that provide a correlation between space and number.","[{'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Pitt', 'Affiliation': 'Department of Psychology, University of Chicago.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Casasanto', 'Affiliation': 'Department of Psychology, University of Chicago.'}]",Journal of experimental psychology. General,['10.1037/xge0000696']
1995,33090910,Whole body passive heating versus dynamic lower body exercise: A comparison of peripheral hemodynamic profiles.,"Passive heating has emerged as a therapeutic intervention for the treatment and prevention of cardiovascular disease. Like exercise, heating increases peripheral artery blood flow and shear rate which is thought to be a primary mechanism underpinning endothelium mediated vascular adaptation. However, few studies have compared the increase in arterial blood flow and shear rate between dynamic exercise and passive heating. In a fixed crossover design study, 15 moderately trained healthy participants (25.6 ± 3.4 years) (5 female) underwent 30 minutes of whole body passive heating (42 °C bath), followed on a separate day by 30 minutes of semi-recumbent stepping exercise performed at two workloads corresponding to the increase in cardiac output (Qc) (Δ3.72 l∙min -1 ) and heart rate (HR) (Δ38 bpm) recorded at the end of passive heating. Results: At the same Qc (Δ3.72 l∙min -1  vs 3.78 l∙min -1 ), femoral artery blood flow (1599 ml/min vs 1947 ml/min) (p=0.596) and shear rate (162 s  -1  vs 192 s -1 ) (p=0.471) measured by ultrasonography were similar between passive heating and stepping exercise. However, for the same HR matched intensity, femoral blood flow (1599 ml·min -1  vs 2588 ml·min -1 ) and shear rate (161s -1  vs 271s -1 ) were significantly greater during exercise, compared with heating (both P=<0.001). The results indicate that, for moderately trained individuals, passive heating increases common femoral artery blood flow and shear rate similar to low intensity continuous dynamic exercise (29% VO 2max ), however exercise performed at a higher intensity (53% VO 2max ) results in significantly larger shear rates towards the active skeletal muscle.",2020,"At the same Qc (Δ3.72 l∙min -1  vs 3.78 l∙min -1 ), femoral artery blood flow (1599 ml/min vs 1947 ml/min) (p=0.596) and shear rate (162 s  -1  vs 192 s -1 ) (p=0.471) measured by ultrasonography were similar between passive heating and stepping exercise.",['15 moderately trained healthy participants (25.6 ± 3.4 years) (5 female) underwent'],"['semi-recumbent stepping exercise', '30 minutes of whole body passive heating', 'Whole body passive heating versus dynamic lower body exercise']","['peripheral artery blood flow and shear rate', 'heart rate (HR', 'femoral artery blood flow and shear rate', 'shear rates', 'femoral blood flow', 'arterial blood flow and shear rate', 'femoral artery blood flow', 'shear rate', 'cardiac output (Qc']","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C4517692', 'cui_str': '3.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0444334', 'cui_str': 'Recumbent body position'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0018851', 'cui_str': 'Heating'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C1268088', 'cui_str': 'Lower body structure'}]","[{'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0175735', 'cui_str': 'Scissors'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0015801', 'cui_str': 'Structure of femoral artery'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0229665', 'cui_str': 'Arterial blood'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}]",15.0,0.03134,"At the same Qc (Δ3.72 l∙min -1  vs 3.78 l∙min -1 ), femoral artery blood flow (1599 ml/min vs 1947 ml/min) (p=0.596) and shear rate (162 s  -1  vs 192 s -1 ) (p=0.471) measured by ultrasonography were similar between passive heating and stepping exercise.","[{'ForeName': 'Sachin Bharat', 'Initials': 'SB', 'LastName': 'Amin', 'Affiliation': 'Department of Sport Science, University of Innsbruck, Austria.'}, {'ForeName': 'Alexander B', 'Initials': 'AB', 'LastName': 'Hansen', 'Affiliation': 'Department of Sport Science, University of Innsbruck, Austria.'}, {'ForeName': 'Hendrik', 'Initials': 'H', 'LastName': 'Mugele', 'Affiliation': 'Department of Sport Science, University of Innsbruck, Austria.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Willmer', 'Affiliation': 'Department of Sport Science, University of Innsbruck, Austria.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Gross', 'Affiliation': 'Department of Sport Science, University of Innsbruck, Austria.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Reimeir', 'Affiliation': 'Department of Sport Science, University of Innsbruck, Austria.'}, {'ForeName': 'William K', 'Initials': 'WK', 'LastName': 'Cornwell', 'Affiliation': 'Department of Medicine, University of Colorado Anschutz Medical Campus, United States.'}, {'ForeName': 'Lydia L', 'Initials': 'LL', 'LastName': 'Simpson', 'Affiliation': 'School of Sport, Health & Exercise Science, Bangor University, Austria.'}, {'ForeName': 'Jonathan P', 'Initials': 'JP', 'LastName': 'Moore', 'Affiliation': 'School of Sport, Health and Exercise Sciences, Bangor University, United Kingdom.'}, {'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Romero', 'Affiliation': 'Human Vascular Physiology Laboratory, Department of Physiology and Anatomy, University of North Texas Health Science Center, United States.'}, {'ForeName': 'Justin Stevan', 'Initials': 'JS', 'LastName': 'Lawley', 'Affiliation': 'Department of Sports Science, Division of Physiology, University of Innsbruck, Austria.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00291.2020']
1996,33090921,"Efficacy and Safety of Multilayer, Extended-Release Methylphenidate (PRC-063) in Children 6-12 Years of Age with Attention-Deficit/Hyperactivity Disorder: A Laboratory Classroom Study.","Objective:  To determine the safety and efficacy of PRC-063, a once-daily, multilayer, extended-release (ER) formulation of methylphenidate (MPH) hydrochloride, in the treatment of attention-deficit/hyperactivity disorder (ADHD) in children in a randomized, double-blind, parallel group, dose-optimized, placebo-controlled phase 3 study.  Methods:  Boys and girls aged 6-12 years diagnosed with ADHD were enrolled. During a 6-week, open-label, dose-optimization phase, subjects began treatment at 25 mg/day of PRC-063 and were titrated until an optimal dose (maximum 85 mg/day) was reached. During the double-blind period, subjects were randomized to receive treatment with their optimal dose of PRC-063 or placebo for 1 week. Efficacy was assessed in a laboratory classroom setting on the final day of the double-blind treatment using the Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Rating Scale and Permanent Product Measure of Performance (PERMP). Safety was assessed measuring adverse events (AEs), vital signs, and electrocardiograms.  Results:  The study was completed by 147 subjects. In the primary efficacy analysis, significant improvements were demonstrated with PRC-063 versus placebo ( p  < 0.0001) when SKAMP-Combined scores were averaged over the 13-hour full-day laboratory classroom (least squares mean difference = -8.6, 95% confidence interval = -10.6 to -6.6). Mean average PERMP-Total scores were also significantly improved with PRC-063 versus placebo at all time points postdose ( p  < 0.01). The onset of treatment effect was present by 1-hour postdose (the first time point measured) and duration of efficacy was up to and including 13 hours postdose. AEs reported in ≥5% of subjects during the dosing optimization period were decreased appetite, abdominal pain upper, affect lability, weight decreased, headache, irritability, and insomnia.  Conclusions:  PRC-063 was effective in improving attention and reducing symptoms of ADHD versus placebo and had a rapid onset and extended duration of effect. AEs were consistent to those reported with other ER MPH treatments. Clinical Trial Registry: NCT03172481.",2020,PRC-063 was effective in improving attention and reducing symptoms of ADHD versus placebo and had a rapid onset and extended duration of effect.,"['Boys and girls aged 6-12 years diagnosed with ADHD were enrolled', '147 subjects', 'Children 6-12 Years of Age with Attention-Deficit/Hyperactivity Disorder', 'attention-deficit/hyperactivity disorder (ADHD) in children']","['Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP', 'placebo', 'PRC-063 or placebo', 'PRC-063', 'methylphenidate (MPH) hydrochloride', 'Multilayer, Extended-Release Methylphenidate (PRC-063']","['SKAMP-Combined scores', 'duration of efficacy', 'Mean average PERMP-Total scores', 'Efficacy', 'Rating Scale and Permanent Product Measure of Performance (PERMP', 'adverse events (AEs), vital signs, and electrocardiograms', 'appetite, abdominal pain upper, affect lability, weight decreased, headache, irritability, and insomnia']","[{'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0700545', 'cui_str': 'Methylphenidate hydrochloride'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0025810', 'cui_str': 'Methylphenidate'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0232492', 'cui_str': 'Upper abdominal pain'}, {'cui': 'C0233472', 'cui_str': 'Labile affect'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0022107', 'cui_str': 'Feeling irritable'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}]",,0.387504,PRC-063 was effective in improving attention and reducing symptoms of ADHD versus placebo and had a rapid onset and extended duration of effect.,"[{'ForeName': 'Ann C', 'Initials': 'AC', 'LastName': 'Childress', 'Affiliation': 'Center for Psychiatry and Behavioral Medicine, Inc., Las Vegas, Nevada, USA.'}, {'ForeName': 'Matthew N', 'Initials': 'MN', 'LastName': 'Brams', 'Affiliation': 'Bayou City Research, Ltd., Houston, Texas, USA.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Cutler', 'Affiliation': 'Neuroscience Education Institute, Lakewood Ranch, Florida, USA.'}, {'ForeName': 'Graeme A E', 'Initials': 'GAE', 'LastName': 'Donnelly', 'Affiliation': 'Purdue Pharma (Canada), Pickering, Canada.'}, {'ForeName': 'Sailaja', 'Initials': 'S', 'LastName': 'Bhaskar', 'Affiliation': 'Imbrium Therapeutics L.P., a subsidiary of Purdue Pharma L.P., Stamford, Connecticut, USA.'}]",Journal of child and adolescent psychopharmacology,['10.1089/cap.2020.0109']
1997,33090945,Immediate Effect of Cervico-thoracic Mobilization on Deep Neck Flexors Strength in Individuals with Forward Head Posture: A Randomized Controlled Trial.,"INTRODUCTION


Forward head posture is the most frequently observed postural deviations and is said to be associated with shortening of posterior cervical extensors and weakening of the anterior deep cervical flexors. Manual therapy has the potential to achieve reflexogenic changes in muscle and enhance the motor activity and strength.
PURPOSE OF THE STUDY


To evaluate the immediate effect of grade IV cervicothoracic Maitland mobilization on deep neck flexors strength in individuals with forward head posture.
STUDY DESIGN


A Single-blinded randomized placebo-controlled trial.
METHOD


Sixty individuals were randomly divided into two groups. Placebo-controlled (PBO) group (n = 30) received the grade I and experimental (EXP) group (n = 30) received grade IV posteroanterior central and unilateral Maitland mobilization from the upper cervical to the upper thoracic spine.  Outcome measure : Clinical Cranio-cervical flexion test (CCFT) was used to measure the motor activity and the strength of deep neck flexors.
RESULTS


The strength of deep neck flexors effectively increased (p = <0.0001) after advocating grade IV mobilization.
CONCLUSION


This study concluded that grade IV central and unilateral posteroanterior Maitland mobilization demonstrated significant increase in the deep neck flexors strength in individuals with forward head posture.",2020,"The strength of deep neck flexors effectively increased (p = <0.0001) after advocating grade IV mobilization.
","['Sixty individuals', 'Individuals with Forward Head Posture', 'individuals with forward head posture']","['Cervico-thoracic Mobilization', 'grade IV posteroanterior central and unilateral Maitland mobilization from the upper cervical to the upper thoracic spine', 'Placebo-controlled (PBO', 'grade IV cervicothoracic Maitland mobilization', 'placebo']","['strength of deep neck flexors effectively', 'motor activity and the strength of deep neck flexors', 'Outcome measure : Clinical Cranio-cervical flexion test (CCFT', 'deep neck flexors strength', 'Deep Neck Flexors Strength']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439780', 'cui_str': 'Forward'}, {'cui': 'C1536116', 'cui_str': 'Head posture abnormal'}]","[{'cui': 'C0205064', 'cui_str': 'Cervical'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0581269', 'cui_str': 'Thoracic spine structure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0450195', 'cui_str': 'Cervicothoracic'}]","[{'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1627359', 'cui_str': 'Flexion test'}]",60.0,0.0436739,"The strength of deep neck flexors effectively increased (p = <0.0001) after advocating grade IV mobilization.
","[{'ForeName': 'Gauri Milind', 'Initials': 'GM', 'LastName': 'Ghan', 'Affiliation': ""Master of Physiotherapy (Musculoskeletal Sciences), MGM's Institute of Physiotherapy , Aurangabad, India.""}, {'ForeName': 'V Sarath', 'Initials': 'VS', 'LastName': 'Babu', 'Affiliation': ""Master in Physiotherapy (Sports), PhD, Professor and Principal, MGM's Institute of Physiotherapy , Aurangabad, India.""}]",The Journal of manual & manipulative therapy,['10.1080/10669817.2020.1834321']
1998,33091102,Screening for expired medications in automated dispensing cabinets.,"PURPOSE


Results of a study to quantify rates of identification of expired medications in automated dispensing cabinets (ADCs) are reported.
METHODS


A pre-post analysis was conducted to determine the effect of various types of ADC audits on rates of finding expired medications in ADCs. For the experimental phase of the study, 4 ADCs at the main campus of an academic medical center were randomly assigned to receive one of 4 interventions: (1) monthly audits of all ADC pockets, (2) monthly audits of matrix (open pocket) drawers only, (3) monthly audits of unassigned pockets only, and (4) no additional intervention.
RESULTS


At baseline, rates of finding expired medication doses in the 4 ADCs ranged from 0.4% to 0.7%. During the 3-month experimental period, rates of finding expired medication doses ranged from 0.1% to 0.3%. During a final audit 1 month later, the ADC targeted for monthly audits of all pockets was found to contain no expired doses, with an overall improvement in expired-dose rates for all audited ADCs observed over the course of the 4-month study. The average time to perform a full audit for an ADC with about 340 pockets was 1 hour, or 15 seconds per pocket. The average time to perform matrix drawer-only audits averaged around 45 minutes, or 11 seconds per pocket. The average time to perform audits of unassigned matrix drawers averaged 30 minutes, or 10 seconds per pocket.
CONCLUSION


Auditing of all ADC pockets on a monthly basis appears to be an effective method of reducing the rate of identificaiton of expired medications in ADC pockets.",2020,"The average time to perform audits of unassigned matrix drawers averaged 30 minutes, or 10 seconds per pocket.
",['4 ADCs at the main campus of an academic medical center'],"['matrix (open pocket) drawers only, (3) monthly audits of unassigned pockets only, and (4) no additional intervention']",['rates of finding expired medication doses'],"[{'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0179481', 'cui_str': 'Cabinet'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}]","[{'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0453897', 'cui_str': 'Drawers'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",,0.0354343,"The average time to perform audits of unassigned matrix drawers averaged 30 minutes, or 10 seconds per pocket.
","[{'ForeName': 'Alexis N', 'Initials': 'AN', 'LastName': 'Nanni', 'Affiliation': 'University of North Carolina Medical Center, Chapel Hill, NC.'}, {'ForeName': 'Trusha S', 'Initials': 'TS', 'LastName': 'Rana', 'Affiliation': 'University of North Carolina Medical Center, Chapel Hill, NC.'}, {'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'Schenkat', 'Affiliation': 'University of North Carolina Medical Center, Chapel Hill, NC.'}]",American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists,['10.1093/ajhp/zxaa318']
1999,33091142,PLIF surgery with titanium-coated PEEK or uncoated PEEK cages: a prospective randomised clinical and radiological study.,"PURPOSE


This study aimed to compare clinical results and fusion rates of uncoated polyetheretherketone (PEEK) cages with titanium-coated PEEK cages in posterior lumbar interbody fusion (PLIF) surgery.
METHODS


A prospective randomised study including 60 patients with one- or two-segment lumbar degenerative diseases. Patients received either titanium-coated PEEK cages (group A) or uncoated PEEK cages (group B). Fusion rates were evaluated on plain X-rays and CT scans after 6 and 12 months. Clinical follow-up (visual analogue scale, VAS; Oswestry Disability Index score, ODI; EQ-5D) was performed for 24 months.
RESULTS


Fifty-five patients (92%) (36 female, 19 male) had a complete follow-up. There were no statistically significant differences in demographic, peri- or intraoperative data between groups A and B. ODI, VAS and EQ-5D improved significantly (p < 0.001) after surgery without statistically significant differences between the two groups. Overall, 65 operated segments could be evaluated for fusion (group A: 29 segments, group B: 36 segments, p = 0.6). Osseous integration of the cage surface improved significantly (p < 0.001) in both groups between 6 and 12 months after surgery. At 12-month follow-up, neither radiolucency nor signs of instability or dislocation were noted. Fusion was present in CT scans as follows: (a) bone growth through cage pores (A: 100%, B: 100%); (b) bone growth outside the cages (A: 48%, B: 61%; p = 0.3).
CONCLUSIONS


PEEK and titanium-coated PEEK cages for PLIF produce equally favourable clinical and radiological results up to 24 months post-surgery. The fusion rate was not different.",2020,Osseous integration of the cage surface improved significantly (p < 0.001) in both groups between 6 and 12 months after surgery.,"['Fifty-five patients (92%) (36 female, 19 male) had a complete follow-up', '60 patients with one- or two-segment lumbar degenerative diseases']","['titanium-coated PEEK cages (group A) or uncoated PEEK cages', 'uncoated polyetheretherketone (PEEK) cages with titanium-coated PEEK cages', 'PLIF surgery with titanium-coated PEEK or uncoated PEEK cages']","['demographic, peri- or intraoperative data between groups A and B. ODI, VAS and EQ-5D', 'radiolucency nor signs of instability or dislocation', 'Clinical follow-up (visual analogue scale, VAS; Oswestry Disability Index score, ODI; EQ-5D', 'Osseous integration of the cage surface', 'fusion rate', 'Fusion rates']","[{'cui': 'C0450382', 'cui_str': '55'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C1285162', 'cui_str': 'Degenerative disorder'}]","[{'cui': 'C0040302', 'cui_str': 'Titanium'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0084113', 'cui_str': 'polyetheretherketone'}, {'cui': 'C0337189', 'cui_str': 'Cage'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0085633', 'cui_str': 'Mood swings'}, {'cui': 'C0012691', 'cui_str': 'Dislocation'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C2960603', 'cui_str': 'Oswestry disability index score'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0337189', 'cui_str': 'Cage'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}]",60.0,0.0456467,Osseous integration of the cage surface improved significantly (p < 0.001) in both groups between 6 and 12 months after surgery.,"[{'ForeName': 'Klaus John', 'Initials': 'KJ', 'LastName': 'Schnake', 'Affiliation': 'Center for Spinal and Scoliosis Surgery, Malteser Waldkrankenhaus St. Marien, Rathsberger Strasse 57, 91054, Erlangen, Germany. klaus.schnake@waldkrankenhaus.de.'}, {'ForeName': 'Nikolai', 'Initials': 'N', 'LastName': 'Fleiter', 'Affiliation': 'Orthopaedicum Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Hoffmann', 'Affiliation': 'Center for Spinal Surgery and Neurotraumatology, BG Unfallklinik Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Pingel', 'Affiliation': 'Center for Spinal Surgery and Neurotraumatology, BG Unfallklinik Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Matti', 'Initials': 'M', 'LastName': 'Scholz', 'Affiliation': 'Center for Spinal Surgery and Neurotraumatology, BG Unfallklinik Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Langheinrich', 'Affiliation': 'Department of Diagnostic and Interventional Radiology, BG Unfallklinik Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Kandziora', 'Affiliation': 'Center for Spinal Surgery and Neurotraumatology, BG Unfallklinik Frankfurt, Frankfurt am Main, Germany.'}]","European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society",['10.1007/s00586-020-06642-x']
2000,33091173,Predicted Cardiac Hemodynamic Consequences of the Renal Actions of SGLT2i in the DAPA-HF Study Population: A Mathematical Modeling Analysis.,"The Dapagliflozin and Prevention of Adverse Outcomes in Heart Failure (DAPA-HF) study demonstrated that dapagliflozin, a sodium-glucose cotransporter-2 inhibitor (SGLT2i), reduced heart failure hospitalization and cardiovascular death in patients with heart failure with reduced ejection fraction (HF-rEF), with and without type 2 diabetes mellitus. Multiple potential mechanisms have been proposed to explain this benefit, which may be multifactorial. This study aimed to quantify the contribution of the known natriuretic/diuretic effects of SGLT2is to changes in cardiac hemodynamics, remodeling, and fluid homeostasis in the setting of HF-rEF. An integrated cardiorenal mathematical model was used to simulate inhibition of SGLT2 and its consequences on cardiac hemodynamics in a virtual population of HF-rEF patients generated by varying model parameters over physiologically plausible ranges and matching to baseline characteristics of individual DAPA-HF trial patients. Cardiovascular responses to placebo and SGLT2i over time were then simulated. The baseline characteristics of the HF-rEF virtual population and DAPA-HF were in good agreement. SGLT2i-induced diuresis and natriuresis that reduced blood volume and interstitial fluid volume, relative to placebo within 14 days. This resulted in decreased left ventricular end-diastolic volume and pressure, indicating reduced cardiac preload. Thereafter, blood volume and interstitial fluid volume again began to accumulate, but pressures and volumes remained shifted lower relative to placebo. After 1 year, left ventricle mass was lower and ejection fraction was higher than placebo. These simulations considered only hemodynamic consequences of the natriuretic/diuretic effects of SGLT2i, as other mechanisms may contribute additional benefits besides those predictions.",2020,"Thereafter, blood volume and interstitial fluid volume again began to accumulate, but pressures and volumes remained shifted lower relative to placebo.","['Heart Failure ', 'patients with heart failure with reduced ejection fraction (HF-rEF), with and without type 2 diabetes mellitus']","['dapagliflozin, a sodium-glucose cotransporter-2 inhibitor (SGLT2i', 'placebo', 'SGLT2i-induced diuresis and natriuresis', 'placebo and SGLT2i']","['left ventricular end-diastolic volume and pressure, indicating reduced cardiac preload', 'left ventricle mass was lower and ejection fraction', 'Cardiovascular responses', 'blood volume and interstitial fluid volume again began to accumulate, but pressures and volumes', 'heart failure hospitalization and cardiovascular death', 'blood volume and interstitial fluid volume', 'cardiac hemodynamics, remodeling, and fluid homeostasis']","[{'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0012797', 'cui_str': 'Diuresis'}, {'cui': 'C0027477', 'cui_str': 'Natriuresis'}]","[{'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042509', 'cui_str': 'Ventricular End-Diastolic Volume'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0007799', 'cui_str': 'Brain ventricle structure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0005850', 'cui_str': 'Blood volume'}, {'cui': 'C0162367', 'cui_str': 'Intercellular Fluid'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}]",,0.107572,"Thereafter, blood volume and interstitial fluid volume again began to accumulate, but pressures and volumes remained shifted lower relative to placebo.","[{'ForeName': 'Hongtao', 'Initials': 'H', 'LastName': 'Yu', 'Affiliation': 'School of Chemical, Materials, and Biomedical Engineering, University of Georgia, Athens, Georgia, USA.'}, {'ForeName': 'Weifeng', 'Initials': 'W', 'LastName': 'Tang', 'Affiliation': 'Clinical Pharmacology and Quantitative Pharmacology, Clinical Pharmacology and Safety Sciences, R&D, AstraZeneca, Gaithersburg, Maryland, USA.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Greasley', 'Affiliation': 'Early Clinical Development, Research, and Early Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Penland', 'Affiliation': 'Clinical Pharmacology and Quantitative Pharmacology, Clinical Pharmacology & Safety Sciences, R&D, AstraZeneca, Boston, Massachusetts, USA.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Boulton', 'Affiliation': 'Clinical Pharmacology and Quantitative Pharmacology, Clinical Pharmacology and Safety Sciences, R&D, AstraZeneca, Gaithersburg, Maryland, USA.'}, {'ForeName': 'K Melissa', 'Initials': 'KM', 'LastName': 'Hallow', 'Affiliation': 'School of Chemical, Materials, and Biomedical Engineering, University of Georgia, Athens, Georgia, USA.'}]",Journal of clinical pharmacology,['10.1002/jcph.1769']
2001,33091174,"Effects of fiber intake on intestinal pH, transit and predicted oral mesalamine delivery in patients with ulcerative colitis.","BACKGROUND


Limited data are available on the effects of fermentable fiber in altering intestinal pH and transit to predict efficacy-based delivery profiles of pH-dependent mesalamine coatings in ulcerative colitis (UC).
AIMS


To examine regional pH and transit after acute changes in fermentable fiber intake in quiescent UC patients and their effects on drug release systems.
METHODS


In a randomized, double-blind study, 18 patients with quiescent UC and 10 healthy controls were supplied meals high (13 g) or low (≤2 g) in fermentable fiber and subsequently ingested a wireless pH-motility capsule. After a ≥3-day washout, they crossed over to the other diet. Measurements of intestinal pH and transit were used to predict drug release for the various pH-dependent coatings.
RESULTS


Increasing fermentable fiber intake lowered overall [median 6.2(6.1-6.7) vs low: 6.9(IQR:6.4-7.4); p=0.01] and distal pH [7.8(7.3-8.1) vs 8.2(8.0-8.5); p=0.04] in controls. In UC patients, only caecal pH was decreased [high:5.1(4.8-5.5) vs low:5.5(5.3-5.7); p<0.01]. Colonic transit in the UC cohort varied widely after a low fiber intake but tended to normalize after the high fermentable fiber intake. Hypothetical coating dissolution profiles were heterogeneous in UC patients, with a multi-matrix delayed release system having the highest likelihood of patients (20-40%) with incomplete dissolution, and predominant small intestinal dissolution predicted for Eudragit L (94% patients) and S (44-69%).
CONCLUSIONS


Patients with quiescent UC have abnormalities in intestinal pH and transit, and in response to acute changes in fermentable fiber intake. These have potentially detrimental effects on predicted luminal release patterns of pH-dependent 5-aminosalicylic acid release systems.",2020,"Hypothetical coating dissolution profiles were heterogeneous in UC patients, with a multi-matrix delayed release system having the highest likelihood of patients (20-40%) with incomplete dissolution, and predominant small intestinal dissolution predicted for Eudragit L (94% patients) and S (44-69%).
","['patients with ulcerative colitis', 'quiescent UC patients', '18 patients with quiescent UC and 10 healthy controls']","['supplied meals high (13 g) or low (≤2 g) in fermentable fiber and subsequently ingested a wireless pH-motility capsule', 'fiber intake']","['caecal pH', 'Colonic transit', 'intestinal pH, transit and predicted oral mesalamine delivery', 'Hypothetical coating dissolution profiles']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0007608', 'cui_str': 'Motility, Cell'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]","[{'cui': 'C0007531', 'cui_str': 'Cecum structure'}, {'cui': 'C0009368', 'cui_str': 'Colonic'}, {'cui': 'C1301827', 'cui_str': 'In transit'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0127615', 'cui_str': 'mesalamine'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0453946', 'cui_str': 'Coat'}]",18.0,0.0867818,"Hypothetical coating dissolution profiles were heterogeneous in UC patients, with a multi-matrix delayed release system having the highest likelihood of patients (20-40%) with incomplete dissolution, and predominant small intestinal dissolution predicted for Eudragit L (94% patients) and S (44-69%).
","[{'ForeName': 'Chu K', 'Initials': 'CK', 'LastName': 'Yao', 'Affiliation': 'Department of Gastroenterology, Monash University and Alfred Hospital, Melbourne, Australia.'}, {'ForeName': 'Rebecca E', 'Initials': 'RE', 'LastName': 'Burgell', 'Affiliation': 'Department of Gastroenterology, Monash University and Alfred Hospital, Melbourne, Australia.'}, {'ForeName': 'Kirstin M', 'Initials': 'KM', 'LastName': 'Taylor', 'Affiliation': 'Department of Gastroenterology, Monash University and Alfred Hospital, Melbourne, Australia.'}, {'ForeName': 'Mark G', 'Initials': 'MG', 'LastName': 'Ward', 'Affiliation': 'Department of Gastroenterology, Monash University and Alfred Hospital, Melbourne, Australia.'}, {'ForeName': 'Antony B', 'Initials': 'AB', 'LastName': 'Friedman', 'Affiliation': 'Department of Gastroenterology, Monash University and Alfred Hospital, Melbourne, Australia.'}, {'ForeName': 'Jacqueline S', 'Initials': 'JS', 'LastName': 'Barrett', 'Affiliation': 'Department of Gastroenterology, Monash University and Alfred Hospital, Melbourne, Australia.'}, {'ForeName': 'Jane G', 'Initials': 'JG', 'LastName': 'Muir', 'Affiliation': 'Department of Gastroenterology, Monash University and Alfred Hospital, Melbourne, Australia.'}, {'ForeName': 'Peter R', 'Initials': 'PR', 'LastName': 'Gibson', 'Affiliation': 'Department of Gastroenterology, Monash University and Alfred Hospital, Melbourne, Australia.'}]",Journal of gastroenterology and hepatology,['10.1111/jgh.15311']
2002,33091192,INEXAS: A Phase 2 Randomised Trial of On-Demand Inhaled Interferon Beta-1a in Severe Asthmatics.,"BACKGROUND


Upper respiratory tract infections (URTI) are important triggers for asthma exacerbations. We hypothesised that inhalation of the anti-viral cytokine, interferon (IFN)-β, during URTI, could prevent these exacerbations.",2020,"We hypothesised that inhalation of the anti-viral cytokine, interferon (IFN)-β, during URTI, could prevent these exacerbations.",['Severe Asthmatics'],['INEXAS'],[],"[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}]",[],[],,0.0925001,"We hypothesised that inhalation of the anti-viral cytokine, interferon (IFN)-β, during URTI, could prevent these exacerbations.","[{'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'McCrae', 'Affiliation': 'Translational Science and Experimental Medicine, Research and Early Development, Respiratory & Immunology, BioPharmaceuticals R&DRespiratory & Immunology, BioPharmaceuticals R&D AstraZeneca Gaithersburg, Maryland, USA.'}]",Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology,['10.1111/cea.13765']
2003,33091202,The efficacy and safety of topical tranexamic acid (liposomal or lotion with microneedling) versus conventional hydroquinone in the treatment of melisma.,"BACKGROUND


Robust evidence regarding the efficacy of topical tranexamic acid (TA) on melasma in Chinese population is lacking.
OBJECTIVE


To evaluate the efficacy and safety of 1.8% liposomal TA and microneedling with 5% TA solution on melasma.
METHODS


Sixty melasma patients were enrolled and randomized to receive 1.8% liposomal TA twice daily, microneedling with 5% TA solution weekly or 2% hydroquinone every night. Objective and subjective assessments were obtained at baseline, 4, 8 and 12 weeks.
RESULTS


27.8% of patients of liposomal TA group, 33.3% of microneedling with TA solution group and 30.0% of hydroquinone group were recognized as ""more than 50% improvement"". At the endpoint, the melanin index (MI) in all treatment groups were significantly decreased, while the improvement of MI in microneedling with TA solution group and hydroquinone group is higher than liposomal TA group. The erythema index (EI) was significantly diminished in liposomal TA group and microneedling with TA solution group. Dermatoscopy and reflectance confocal microscopy revealed decreased brown granules in all groups and reduced telangiectasia in liposomal TA group and microneedling with TA solution group.
CONCLUSION


1.8% liposomal TA and microneedling with 5% TA solution are both effective and safe on melasma.",2020,The erythema index (EI) was significantly diminished in liposomal TA group and microneedling with TA solution group.,['Sixty melasma patients'],"['hydroquinone', 'liposomal TA and microneedling with 5% TA solution', 'topical tranexamic acid (TA', 'liposomal TA', 'topical tranexamic acid (liposomal or lotion with microneedling) versus conventional hydroquinone', 'liposomal TA twice daily, microneedling with 5% TA solution weekly or 2% hydroquinone every night']","['Objective and subjective assessments', 'efficacy and safety', 'melanin index (MI', 'erythema index (EI', 'effective and safe on melasma']","[{'cui': 'C0025218', 'cui_str': 'Chloasma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0020306', 'cui_str': 'hydroquinone'}, {'cui': 'C0023828', 'cui_str': 'Liposomes'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0544341', 'cui_str': 'Lotion'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0240526', 'cui_str': 'Night time'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0025196', 'cui_str': 'Melanin'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0025218', 'cui_str': 'Chloasma'}]",60.0,0.0334802,The erythema index (EI) was significantly diminished in liposomal TA group and microneedling with TA solution group.,"[{'ForeName': 'Xiaoxue', 'Initials': 'X', 'LastName': 'Xing', 'Affiliation': 'Department of Dermatology, Huashan Hospital, Fudan University, Shanghai, 200040, PR China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Dermatology, Huashan Hospital, Fudan University, Shanghai, 200040, PR China.'}, {'ForeName': 'Zhongyi', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'Department of Dermatology, Huashan Hospital, Fudan University, Shanghai, 200040, PR China.'}, {'ForeName': 'Shanglin', 'Initials': 'S', 'LastName': 'Jin', 'Affiliation': 'Department of Dermatology, Huashan Hospital, Fudan University, Shanghai, 200040, PR China.'}, {'ForeName': 'Chengfeng', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Department of Dermatology, Huashan Hospital, Fudan University, Shanghai, 200040, PR China.'}, {'ForeName': 'Leihong', 'Initials': 'L', 'LastName': 'Xiang', 'Affiliation': 'Department of Dermatology, Huashan Hospital, Fudan University, Shanghai, 200040, PR China.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13810']
2004,33085801,Effectiveness of a targeted and tailored pharmacist-led intervention to improve adherence to antihypertensive drugs among patients with type 2 diabetes in Indonesia: a cluster randomised controlled trial.,"AIM


To assess the effects of a targeted and tailored pharmacist-led intervention among patients with type 2 diabetes (T2DM) who are non-adherent to antihypertensive drugs.
METHODS


A cluster-randomised controlled trial was conducted in 10 community health centres (CHCs) in Indonesia among T2DM patients aged ≥18 years who reported non-adherence to antihypertensive drugs according to the Medication Adherence Report Scale (MARS-5). Patients in CHCs randomised to the intervention group received a tailored intervention based on their adherence barriers (e.g., forgetfulness, lack of knowledge, lack of motivation, and/or other drug-related problems) using a simple question-based flowchart at baseline and 1-month follow-up. Patients in control CHCs received usual care. Primary outcome was the between-group difference in change in MARS-5 score from baseline to 3-months follow-up. Secondary outcomes included changes in patients' blood pressure and their medication beliefs. Differences in difference in primary and secondary outcomes between groups were assessed using General Linear Models.
RESULTS


In total, 201 patients were screened for eligibility, 113 met the inclusion criteria and participated; 89 (79%) patients had complete follow-up. Forgetfulness (42%) and lack of knowledge (18%) were the most common adherence barriers identified at baseline. The intervention improved medication adherence by 4.62 points on the MARS-5 scale [95%CI: 0.93 to 8.34, p-value = 0.008]. There were no significant changes in blood pressure levels and beliefs about antihypertensive drugs.
CONCLUSION


A tailored low-cost pharmacist-led intervention aimed at non-adherent T2DM patients resulted in an improvement in medication adherence to antihypertensive drugs. There were no significant changes in secondary outcomes.",2020,"The intervention improved medication adherence by 4.62 points on the MARS-5 scale [95%CI: 0.93 to 8.34, p-value = 0.008].","['patients with type 2 diabetes in Indonesia', '10 community health centres (CHCs) in Indonesia among T2DM patients aged ≥18 years who reported non-adherence to antihypertensive drugs according to the Medication Adherence Report Scale (MARS-5', 'patients with type 2 diabetes (T2DM) who are non-adherent to antihypertensive drugs', '201 patients were screened for eligibility, 113 met the inclusion criteria and participated; 89 (79%) patients had complete follow-up']","['tailored intervention based on their adherence barriers (e.g., forgetfulness, lack of knowledge, lack of motivation, and/or other drug-related problems) using a simple question-based flowchart at baseline and 1-month follow-up', 'targeted and tailored pharmacist-led intervention', 'usual care']","['blood pressure levels and beliefs about antihypertensive drugs', 'change in MARS-5 score', ""patients' blood pressure and their medication beliefs"", 'lack of knowledge', 'Forgetfulness', 'medication adherence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0021247', 'cui_str': 'Indonesia'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0376405', 'cui_str': 'Noncompliance with treatment'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0024782', 'cui_str': 'Marathi language'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0542476', 'cui_str': 'Forgetful'}, {'cui': 'C1998986', 'cui_str': 'Deficient knowledge'}, {'cui': 'C0456814', 'cui_str': 'Loss of motivation'}, {'cui': 'C0205394', 'cui_str': 'Other'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0016262', 'cui_str': 'Flowcharts'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0023175', 'cui_str': 'Lead'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0024782', 'cui_str': 'Marathi language'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1998986', 'cui_str': 'Deficient knowledge'}, {'cui': 'C0542476', 'cui_str': 'Forgetful'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}]",201.0,0.150538,"The intervention improved medication adherence by 4.62 points on the MARS-5 scale [95%CI: 0.93 to 8.34, p-value = 0.008].","[{'ForeName': 'Sofa D', 'Initials': 'SD', 'LastName': 'Alfian', 'Affiliation': 'University of Groningen, Groningen Research Institute of Pharmacy, Unit Pharmaco-Therapy, -Epidemiology & -Economics, Groningen, the Netherlands.'}, {'ForeName': 'Job F M', 'Initials': 'JFM', 'LastName': 'van Boven', 'Affiliation': 'University of Groningen, University Medical Centre Groningen, Department of Clinical Pharmacy and Pharmacology, Groningen, the Netherlands.'}, {'ForeName': 'Rizky', 'Initials': 'R', 'LastName': 'Abdulah', 'Affiliation': 'Universitas Padjadjaran, Faculty of Pharmacy, Department of Pharmacology and Clinical Pharmacy, Jatinangor, Indonesia.'}, {'ForeName': 'Hadyana', 'Initials': 'H', 'LastName': 'Sukandar', 'Affiliation': 'Universitas Padjadjaran, Faculty of Medicine, Department of Public Health, Bandung, Indonesia.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Denig', 'Affiliation': 'University of Groningen, University Medical Centre Groningen, Department of Clinical Pharmacy and Pharmacology, Groningen, the Netherlands.'}, {'ForeName': 'Eelko', 'Initials': 'E', 'LastName': 'Hak', 'Affiliation': 'University of Groningen, Groningen Research Institute of Pharmacy, Unit Pharmaco-Therapy, -Epidemiology & -Economics, Groningen, the Netherlands.'}]",British journal of clinical pharmacology,['10.1111/bcp.14610']
2005,33085857,Efficacy of Tocilizumab in Patients Hospitalized with Covid-19.,"BACKGROUND


The efficacy of interleukin-6 receptor blockade in hospitalized patients with coronavirus disease 2019 (Covid-19) who are not receiving mechanical ventilation is unclear.
METHODS


We performed a randomized, double-blind, placebo-controlled trial involving patients with confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, hyperinflammatory states, and at least two of the following signs: fever (body temperature >38°C), pulmonary infiltrates, or the need for supplemental oxygen in order to maintain an oxygen saturation greater than 92%. Patients were randomly assigned in a 2:1 ratio to receive standard care plus a single dose of either tocilizumab (8 mg per kilogram of body weight) or placebo. The primary outcome was intubation or death, assessed in a time-to-event analysis. The secondary efficacy outcomes were clinical worsening and discontinuation of supplemental oxygen among patients who had been receiving it at baseline, both assessed in time-to-event analyses.
RESULTS


We enrolled 243 patients; 141 (58%) were men, and 102 (42%) were women. The median age was 59.8 years (range, 21.7 to 85.4), and 45% of the patients were Hispanic or Latino. The hazard ratio for intubation or death in the tocilizumab group as compared with the placebo group was 0.83 (95% confidence interval [CI], 0.38 to 1.81; P = 0.64), and the hazard ratio for disease worsening was 1.11 (95% CI, 0.59 to 2.10; P = 0.73). At 14 days, 18.0% of the patients in the tocilizumab group and 14.9% of the patients in the placebo group had had worsening of disease. The median time to discontinuation of supplemental oxygen was 5.0 days (95% CI, 3.8 to 7.6) in the tocilizumab group and 4.9 days (95% CI, 3.8 to 7.8) in the placebo group (P = 0.69). At 14 days, 24.6% of the patients in the tocilizumab group and 21.2% of the patients in the placebo group were still receiving supplemental oxygen. Patients who received tocilizumab had fewer serious infections than patients who received placebo.
CONCLUSIONS


Tocilizumab was not effective for preventing intubation or death in moderately ill hospitalized patients with Covid-19. Some benefit or harm cannot be ruled out, however, because the confidence intervals for efficacy comparisons were wide. (Funded by Genentech; ClinicalTrials.gov number, NCT04356937.).",2020,"CONCLUSIONS


Tocilizumab was not effective for preventing intubation or death in moderately ill hospitalized patients with Covid-19.","['Patients Hospitalized with Covid-19', 'We enrolled 243 patients; 141 (58%) were men, and 102 (42%) were women', 'patients with confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, hyperinflammatory states, and at least two of the following signs: fever (body temperature >38°C), pulmonary infiltrates, or the need for supplemental oxygen in order to maintain an oxygen saturation greater than 92', 'hospitalized patients with coronavirus disease 2019 (Covid-19) who are not receiving', 'moderately ill hospitalized patients with Covid-19', 'The median age was 59.8 years (range, 21.7 to 85.4), and 45% of the patients were Hispanic or Latino']","['mechanical ventilation', 'Tocilizumab', 'placebo', 'interleukin-6 receptor blockade', 'tocilizumab']","['intubation or death, assessed in a time-to-event analysis', 'clinical worsening and discontinuation of supplemental oxygen', 'worsening of disease', 'serious infections', 'hazard ratio for disease worsening', 'still receiving supplemental oxygen', 'median time to discontinuation of supplemental oxygen', 'hazard ratio for intubation or death', 'intubation or death']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0235896', 'cui_str': 'Lung infiltration'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C5191366', 'cui_str': '21.7'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}]","[{'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C1609165', 'cui_str': 'tocilizumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0063717', 'cui_str': 'Lymphocyte antigen CD126'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}]","[{'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",243.0,0.755769,"CONCLUSIONS


Tocilizumab was not effective for preventing intubation or death in moderately ill hospitalized patients with Covid-19.","[{'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Stone', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Frigault', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Naomi J', 'Initials': 'NJ', 'LastName': 'Serling-Boyd', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Ana D', 'Initials': 'AD', 'LastName': 'Fernandes', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Liam', 'Initials': 'L', 'LastName': 'Harvey', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Andrea S', 'Initials': 'AS', 'LastName': 'Foulkes', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Nora K', 'Initials': 'NK', 'LastName': 'Horick', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Brian C', 'Initials': 'BC', 'LastName': 'Healy', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Ruta', 'Initials': 'R', 'LastName': 'Shah', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Ana Maria', 'Initials': 'AM', 'LastName': 'Bensaci', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Ann E', 'Initials': 'AE', 'LastName': 'Woolley', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Nikiforow', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Lin', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Manish', 'Initials': 'M', 'LastName': 'Sagar', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Schrager', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Huckins', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Axelrod', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Pincus', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Fleisher', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Chana A', 'Initials': 'CA', 'LastName': 'Sacks', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Dougan', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Crystal M', 'Initials': 'CM', 'LastName': 'North', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Yuan-Di', 'Initials': 'YD', 'LastName': 'Halvorsen', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Tara K', 'Initials': 'TK', 'LastName': 'Thurber', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Zeina', 'Initials': 'Z', 'LastName': 'Dagher', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Scherer', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Rachel S', 'Initials': 'RS', 'LastName': 'Wallwork', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Arthur Y', 'Initials': 'AY', 'LastName': 'Kim', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Schoenfeld', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Pritha', 'Initials': 'P', 'LastName': 'Sen', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Tomas G', 'Initials': 'TG', 'LastName': 'Neilan', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Cory A', 'Initials': 'CA', 'LastName': 'Perugino', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Sebastian H', 'Initials': 'SH', 'LastName': 'Unizony', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Deborah S', 'Initials': 'DS', 'LastName': 'Collier', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Matza', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Janeth M', 'Initials': 'JM', 'LastName': 'Yinh', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Kathryn A', 'Initials': 'KA', 'LastName': 'Bowman', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Meyerowitz', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Amna', 'Initials': 'A', 'LastName': 'Zafar', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Zsofia D', 'Initials': 'ZD', 'LastName': 'Drobni', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Marcy B', 'Initials': 'MB', 'LastName': 'Bolster', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Minna', 'Initials': 'M', 'LastName': 'Kohler', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Kristin M', 'Initials': 'KM', 'LastName': ""D'Silva"", 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Dau', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Megan M', 'Initials': 'MM', 'LastName': 'Lockwood', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Cubbison', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Brittany N', 'Initials': 'BN', 'LastName': 'Weber', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Mansour', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2028836']
2006,33085861,Anti-Siglec-8 Antibody for Eosinophilic Gastritis and Duodenitis.,"BACKGROUND


Eosinophilic gastritis and duodenitis are characterized by gastrointestinal mucosal eosinophilia, chronic symptoms, impaired quality of life, and a lack of adequate treatments. Mast-cell activity may contribute to the pathogenesis of the conditions. AK002 (lirentelimab) is an anti-Siglec-8 antibody that depletes eosinophils and inhibits mast cells and that has shown potential in animal models as a treatment for eosinophilic gastritis and duodenitis.
METHODS


In this phase 2 trial, we randomly assigned adults who had symptomatic eosinophilic gastritis, eosinophilic duodenitis, or both conditions in a 1:1:1 ratio to receive four monthly infusions of low-dose AK002, high-dose AK002, or placebo. The primary end point was the change in gastrointestinal eosinophil count from baseline to 2 weeks after the final dose; to maximize statistical power, we evaluated this end point in the placebo group as compared with the combined AK002 group. Secondary end points were treatment response (>30% reduction in total symptom score and >75% reduction in gastrointestinal eosinophil count) and the change in total symptom score.
RESULTS


Of the 65 patients who underwent randomization, 43 were assigned to receive AK002 and 22 were assigned to receive placebo. The mean percentage change in gastrointestinal eosinophil count was -86% in the combined AK002 group, as compared with 9% in the placebo group (least-squares mean difference, -98 percentage points; 95% confidence interval [CI], -121 to -76; P<0.001). Treatment response occurred in 63% of the patients who received AK002 and in 5% of the patients who received placebo (difference, 58 percentage points; 95% CI, 36 to 74; P<0.001). The mean change in total symptom score was -48% with AK002 and -22% with placebo (least-squares mean difference, -26 percentage points; 95% CI, -44 to -9; P = 0.004). Adverse events associated with AK002 were similar to those with placebo, with the exception of higher percentages of patients having mild-to-moderate infusion-related reactions with AK002 (60% in the combined AK002 group and 23% in the placebo group).
CONCLUSIONS


In patients with eosinophilic gastritis or duodenitis, AK002 reduced gastrointestinal eosinophils and symptoms. Infusion-related reactions were more common with AK002 than with placebo. (Funded by Allakos; ENIGMA ClinicalTrials.gov number, NCT03496571.).",2020,"Treatment response occurred in 63% of the patients who received AK002 and in 5% of the patients who received placebo (difference, 58 percentage points; 95% CI, 36 to 74; P<0.001).","['adults who had symptomatic eosinophilic gastritis, eosinophilic duodenitis, or both conditions in a 1:1:1 ratio to receive four monthly infusions of', '65 patients who underwent randomization']","['placebo', 'low-dose AK002, high-dose AK002, or placebo']","['gastrointestinal eosinophil count', 'total symptom score', 'gastrointestinal eosinophils and symptoms', 'mean change in total symptom score', 'change in gastrointestinal eosinophil count', 'Treatment response']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0267154', 'cui_str': 'Eosinophilic gastritis'}, {'cui': 'C4305493', 'cui_str': 'Eosinophilic duodenitis'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0444956', 'cui_str': 'High dose'}]","[{'cui': 'C0200638', 'cui_str': 'Eosinophil count'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",,0.46767,"Treatment response occurred in 63% of the patients who received AK002 and in 5% of the patients who received placebo (difference, 58 percentage points; 95% CI, 36 to 74; P<0.001).","[{'ForeName': 'Evan S', 'Initials': 'ES', 'LastName': 'Dellon', 'Affiliation': ""From the University of North Carolina, Chapel Hill (E.S.D.); the University of Utah, Salt Lake City (K.A.P.); Mayo Clinic Rochester, Rochester, MN (J.A.M., A.C.B.); the University of Pennsylvania Perelman School of Medicine, Philadelphia (G.W.F.); Northwestern University, Chicago (N.G., I.H.); the Icahn School of Medicine at Mount Sinai, New York (M.C.); Baylor College of Medicine, Houston (R.M.G.); Tufts University, Boston (J.L.); the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (P.K., A.D.K.); Ventura Clinical Trials, Ventura (S.H.), and Allakos, Redwood City (C.S., A.T.C., B.S., A.P.K., H.S.R.) - both in California; Vanderbilt University, Nashville (M.V.); the Division of Allergy and Immunology, Cincinnati Children's Hospital, University of Cincinnati College of Medicine, Cincinnati (S.R.D., M.E.R.); and Pharma Data Associates, Piscataway, NJ (C.W.).""}, {'ForeName': 'Kathryn A', 'Initials': 'KA', 'LastName': 'Peterson', 'Affiliation': ""From the University of North Carolina, Chapel Hill (E.S.D.); the University of Utah, Salt Lake City (K.A.P.); Mayo Clinic Rochester, Rochester, MN (J.A.M., A.C.B.); the University of Pennsylvania Perelman School of Medicine, Philadelphia (G.W.F.); Northwestern University, Chicago (N.G., I.H.); the Icahn School of Medicine at Mount Sinai, New York (M.C.); Baylor College of Medicine, Houston (R.M.G.); Tufts University, Boston (J.L.); the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (P.K., A.D.K.); Ventura Clinical Trials, Ventura (S.H.), and Allakos, Redwood City (C.S., A.T.C., B.S., A.P.K., H.S.R.) - both in California; Vanderbilt University, Nashville (M.V.); the Division of Allergy and Immunology, Cincinnati Children's Hospital, University of Cincinnati College of Medicine, Cincinnati (S.R.D., M.E.R.); and Pharma Data Associates, Piscataway, NJ (C.W.).""}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Murray', 'Affiliation': ""From the University of North Carolina, Chapel Hill (E.S.D.); the University of Utah, Salt Lake City (K.A.P.); Mayo Clinic Rochester, Rochester, MN (J.A.M., A.C.B.); the University of Pennsylvania Perelman School of Medicine, Philadelphia (G.W.F.); Northwestern University, Chicago (N.G., I.H.); the Icahn School of Medicine at Mount Sinai, New York (M.C.); Baylor College of Medicine, Houston (R.M.G.); Tufts University, Boston (J.L.); the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (P.K., A.D.K.); Ventura Clinical Trials, Ventura (S.H.), and Allakos, Redwood City (C.S., A.T.C., B.S., A.P.K., H.S.R.) - both in California; Vanderbilt University, Nashville (M.V.); the Division of Allergy and Immunology, Cincinnati Children's Hospital, University of Cincinnati College of Medicine, Cincinnati (S.R.D., M.E.R.); and Pharma Data Associates, Piscataway, NJ (C.W.).""}, {'ForeName': 'Gary W', 'Initials': 'GW', 'LastName': 'Falk', 'Affiliation': ""From the University of North Carolina, Chapel Hill (E.S.D.); the University of Utah, Salt Lake City (K.A.P.); Mayo Clinic Rochester, Rochester, MN (J.A.M., A.C.B.); the University of Pennsylvania Perelman School of Medicine, Philadelphia (G.W.F.); Northwestern University, Chicago (N.G., I.H.); the Icahn School of Medicine at Mount Sinai, New York (M.C.); Baylor College of Medicine, Houston (R.M.G.); Tufts University, Boston (J.L.); the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (P.K., A.D.K.); Ventura Clinical Trials, Ventura (S.H.), and Allakos, Redwood City (C.S., A.T.C., B.S., A.P.K., H.S.R.) - both in California; Vanderbilt University, Nashville (M.V.); the Division of Allergy and Immunology, Cincinnati Children's Hospital, University of Cincinnati College of Medicine, Cincinnati (S.R.D., M.E.R.); and Pharma Data Associates, Piscataway, NJ (C.W.).""}, {'ForeName': 'Nirmala', 'Initials': 'N', 'LastName': 'Gonsalves', 'Affiliation': ""From the University of North Carolina, Chapel Hill (E.S.D.); the University of Utah, Salt Lake City (K.A.P.); Mayo Clinic Rochester, Rochester, MN (J.A.M., A.C.B.); the University of Pennsylvania Perelman School of Medicine, Philadelphia (G.W.F.); Northwestern University, Chicago (N.G., I.H.); the Icahn School of Medicine at Mount Sinai, New York (M.C.); Baylor College of Medicine, Houston (R.M.G.); Tufts University, Boston (J.L.); the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (P.K., A.D.K.); Ventura Clinical Trials, Ventura (S.H.), and Allakos, Redwood City (C.S., A.T.C., B.S., A.P.K., H.S.R.) - both in California; Vanderbilt University, Nashville (M.V.); the Division of Allergy and Immunology, Cincinnati Children's Hospital, University of Cincinnati College of Medicine, Cincinnati (S.R.D., M.E.R.); and Pharma Data Associates, Piscataway, NJ (C.W.).""}, {'ForeName': 'Mirna', 'Initials': 'M', 'LastName': 'Chehade', 'Affiliation': ""From the University of North Carolina, Chapel Hill (E.S.D.); the University of Utah, Salt Lake City (K.A.P.); Mayo Clinic Rochester, Rochester, MN (J.A.M., A.C.B.); the University of Pennsylvania Perelman School of Medicine, Philadelphia (G.W.F.); Northwestern University, Chicago (N.G., I.H.); the Icahn School of Medicine at Mount Sinai, New York (M.C.); Baylor College of Medicine, Houston (R.M.G.); Tufts University, Boston (J.L.); the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (P.K., A.D.K.); Ventura Clinical Trials, Ventura (S.H.), and Allakos, Redwood City (C.S., A.T.C., B.S., A.P.K., H.S.R.) - both in California; Vanderbilt University, Nashville (M.V.); the Division of Allergy and Immunology, Cincinnati Children's Hospital, University of Cincinnati College of Medicine, Cincinnati (S.R.D., M.E.R.); and Pharma Data Associates, Piscataway, NJ (C.W.).""}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Genta', 'Affiliation': ""From the University of North Carolina, Chapel Hill (E.S.D.); the University of Utah, Salt Lake City (K.A.P.); Mayo Clinic Rochester, Rochester, MN (J.A.M., A.C.B.); the University of Pennsylvania Perelman School of Medicine, Philadelphia (G.W.F.); Northwestern University, Chicago (N.G., I.H.); the Icahn School of Medicine at Mount Sinai, New York (M.C.); Baylor College of Medicine, Houston (R.M.G.); Tufts University, Boston (J.L.); the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (P.K., A.D.K.); Ventura Clinical Trials, Ventura (S.H.), and Allakos, Redwood City (C.S., A.T.C., B.S., A.P.K., H.S.R.) - both in California; Vanderbilt University, Nashville (M.V.); the Division of Allergy and Immunology, Cincinnati Children's Hospital, University of Cincinnati College of Medicine, Cincinnati (S.R.D., M.E.R.); and Pharma Data Associates, Piscataway, NJ (C.W.).""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Leung', 'Affiliation': ""From the University of North Carolina, Chapel Hill (E.S.D.); the University of Utah, Salt Lake City (K.A.P.); Mayo Clinic Rochester, Rochester, MN (J.A.M., A.C.B.); the University of Pennsylvania Perelman School of Medicine, Philadelphia (G.W.F.); Northwestern University, Chicago (N.G., I.H.); the Icahn School of Medicine at Mount Sinai, New York (M.C.); Baylor College of Medicine, Houston (R.M.G.); Tufts University, Boston (J.L.); the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (P.K., A.D.K.); Ventura Clinical Trials, Ventura (S.H.), and Allakos, Redwood City (C.S., A.T.C., B.S., A.P.K., H.S.R.) - both in California; Vanderbilt University, Nashville (M.V.); the Division of Allergy and Immunology, Cincinnati Children's Hospital, University of Cincinnati College of Medicine, Cincinnati (S.R.D., M.E.R.); and Pharma Data Associates, Piscataway, NJ (C.W.).""}, {'ForeName': 'Paneez', 'Initials': 'P', 'LastName': 'Khoury', 'Affiliation': ""From the University of North Carolina, Chapel Hill (E.S.D.); the University of Utah, Salt Lake City (K.A.P.); Mayo Clinic Rochester, Rochester, MN (J.A.M., A.C.B.); the University of Pennsylvania Perelman School of Medicine, Philadelphia (G.W.F.); Northwestern University, Chicago (N.G., I.H.); the Icahn School of Medicine at Mount Sinai, New York (M.C.); Baylor College of Medicine, Houston (R.M.G.); Tufts University, Boston (J.L.); the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (P.K., A.D.K.); Ventura Clinical Trials, Ventura (S.H.), and Allakos, Redwood City (C.S., A.T.C., B.S., A.P.K., H.S.R.) - both in California; Vanderbilt University, Nashville (M.V.); the Division of Allergy and Immunology, Cincinnati Children's Hospital, University of Cincinnati College of Medicine, Cincinnati (S.R.D., M.E.R.); and Pharma Data Associates, Piscataway, NJ (C.W.).""}, {'ForeName': 'Amy D', 'Initials': 'AD', 'LastName': 'Klion', 'Affiliation': ""From the University of North Carolina, Chapel Hill (E.S.D.); the University of Utah, Salt Lake City (K.A.P.); Mayo Clinic Rochester, Rochester, MN (J.A.M., A.C.B.); the University of Pennsylvania Perelman School of Medicine, Philadelphia (G.W.F.); Northwestern University, Chicago (N.G., I.H.); the Icahn School of Medicine at Mount Sinai, New York (M.C.); Baylor College of Medicine, Houston (R.M.G.); Tufts University, Boston (J.L.); the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (P.K., A.D.K.); Ventura Clinical Trials, Ventura (S.H.), and Allakos, Redwood City (C.S., A.T.C., B.S., A.P.K., H.S.R.) - both in California; Vanderbilt University, Nashville (M.V.); the Division of Allergy and Immunology, Cincinnati Children's Hospital, University of Cincinnati College of Medicine, Cincinnati (S.R.D., M.E.R.); and Pharma Data Associates, Piscataway, NJ (C.W.).""}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Hazan', 'Affiliation': ""From the University of North Carolina, Chapel Hill (E.S.D.); the University of Utah, Salt Lake City (K.A.P.); Mayo Clinic Rochester, Rochester, MN (J.A.M., A.C.B.); the University of Pennsylvania Perelman School of Medicine, Philadelphia (G.W.F.); Northwestern University, Chicago (N.G., I.H.); the Icahn School of Medicine at Mount Sinai, New York (M.C.); Baylor College of Medicine, Houston (R.M.G.); Tufts University, Boston (J.L.); the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (P.K., A.D.K.); Ventura Clinical Trials, Ventura (S.H.), and Allakos, Redwood City (C.S., A.T.C., B.S., A.P.K., H.S.R.) - both in California; Vanderbilt University, Nashville (M.V.); the Division of Allergy and Immunology, Cincinnati Children's Hospital, University of Cincinnati College of Medicine, Cincinnati (S.R.D., M.E.R.); and Pharma Data Associates, Piscataway, NJ (C.W.).""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Vaezi', 'Affiliation': ""From the University of North Carolina, Chapel Hill (E.S.D.); the University of Utah, Salt Lake City (K.A.P.); Mayo Clinic Rochester, Rochester, MN (J.A.M., A.C.B.); the University of Pennsylvania Perelman School of Medicine, Philadelphia (G.W.F.); Northwestern University, Chicago (N.G., I.H.); the Icahn School of Medicine at Mount Sinai, New York (M.C.); Baylor College of Medicine, Houston (R.M.G.); Tufts University, Boston (J.L.); the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (P.K., A.D.K.); Ventura Clinical Trials, Ventura (S.H.), and Allakos, Redwood City (C.S., A.T.C., B.S., A.P.K., H.S.R.) - both in California; Vanderbilt University, Nashville (M.V.); the Division of Allergy and Immunology, Cincinnati Children's Hospital, University of Cincinnati College of Medicine, Cincinnati (S.R.D., M.E.R.); and Pharma Data Associates, Piscataway, NJ (C.W.).""}, {'ForeName': 'Adam C', 'Initials': 'AC', 'LastName': 'Bledsoe', 'Affiliation': ""From the University of North Carolina, Chapel Hill (E.S.D.); the University of Utah, Salt Lake City (K.A.P.); Mayo Clinic Rochester, Rochester, MN (J.A.M., A.C.B.); the University of Pennsylvania Perelman School of Medicine, Philadelphia (G.W.F.); Northwestern University, Chicago (N.G., I.H.); the Icahn School of Medicine at Mount Sinai, New York (M.C.); Baylor College of Medicine, Houston (R.M.G.); Tufts University, Boston (J.L.); the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (P.K., A.D.K.); Ventura Clinical Trials, Ventura (S.H.), and Allakos, Redwood City (C.S., A.T.C., B.S., A.P.K., H.S.R.) - both in California; Vanderbilt University, Nashville (M.V.); the Division of Allergy and Immunology, Cincinnati Children's Hospital, University of Cincinnati College of Medicine, Cincinnati (S.R.D., M.E.R.); and Pharma Data Associates, Piscataway, NJ (C.W.).""}, {'ForeName': 'Sandy R', 'Initials': 'SR', 'LastName': 'Durrani', 'Affiliation': ""From the University of North Carolina, Chapel Hill (E.S.D.); the University of Utah, Salt Lake City (K.A.P.); Mayo Clinic Rochester, Rochester, MN (J.A.M., A.C.B.); the University of Pennsylvania Perelman School of Medicine, Philadelphia (G.W.F.); Northwestern University, Chicago (N.G., I.H.); the Icahn School of Medicine at Mount Sinai, New York (M.C.); Baylor College of Medicine, Houston (R.M.G.); Tufts University, Boston (J.L.); the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (P.K., A.D.K.); Ventura Clinical Trials, Ventura (S.H.), and Allakos, Redwood City (C.S., A.T.C., B.S., A.P.K., H.S.R.) - both in California; Vanderbilt University, Nashville (M.V.); the Division of Allergy and Immunology, Cincinnati Children's Hospital, University of Cincinnati College of Medicine, Cincinnati (S.R.D., M.E.R.); and Pharma Data Associates, Piscataway, NJ (C.W.).""}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': ""From the University of North Carolina, Chapel Hill (E.S.D.); the University of Utah, Salt Lake City (K.A.P.); Mayo Clinic Rochester, Rochester, MN (J.A.M., A.C.B.); the University of Pennsylvania Perelman School of Medicine, Philadelphia (G.W.F.); Northwestern University, Chicago (N.G., I.H.); the Icahn School of Medicine at Mount Sinai, New York (M.C.); Baylor College of Medicine, Houston (R.M.G.); Tufts University, Boston (J.L.); the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (P.K., A.D.K.); Ventura Clinical Trials, Ventura (S.H.), and Allakos, Redwood City (C.S., A.T.C., B.S., A.P.K., H.S.R.) - both in California; Vanderbilt University, Nashville (M.V.); the Division of Allergy and Immunology, Cincinnati Children's Hospital, University of Cincinnati College of Medicine, Cincinnati (S.R.D., M.E.R.); and Pharma Data Associates, Piscataway, NJ (C.W.).""}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Shaw', 'Affiliation': ""From the University of North Carolina, Chapel Hill (E.S.D.); the University of Utah, Salt Lake City (K.A.P.); Mayo Clinic Rochester, Rochester, MN (J.A.M., A.C.B.); the University of Pennsylvania Perelman School of Medicine, Philadelphia (G.W.F.); Northwestern University, Chicago (N.G., I.H.); the Icahn School of Medicine at Mount Sinai, New York (M.C.); Baylor College of Medicine, Houston (R.M.G.); Tufts University, Boston (J.L.); the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (P.K., A.D.K.); Ventura Clinical Trials, Ventura (S.H.), and Allakos, Redwood City (C.S., A.T.C., B.S., A.P.K., H.S.R.) - both in California; Vanderbilt University, Nashville (M.V.); the Division of Allergy and Immunology, Cincinnati Children's Hospital, University of Cincinnati College of Medicine, Cincinnati (S.R.D., M.E.R.); and Pharma Data Associates, Piscataway, NJ (C.W.).""}, {'ForeName': 'Alan T', 'Initials': 'AT', 'LastName': 'Chang', 'Affiliation': ""From the University of North Carolina, Chapel Hill (E.S.D.); the University of Utah, Salt Lake City (K.A.P.); Mayo Clinic Rochester, Rochester, MN (J.A.M., A.C.B.); the University of Pennsylvania Perelman School of Medicine, Philadelphia (G.W.F.); Northwestern University, Chicago (N.G., I.H.); the Icahn School of Medicine at Mount Sinai, New York (M.C.); Baylor College of Medicine, Houston (R.M.G.); Tufts University, Boston (J.L.); the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (P.K., A.D.K.); Ventura Clinical Trials, Ventura (S.H.), and Allakos, Redwood City (C.S., A.T.C., B.S., A.P.K., H.S.R.) - both in California; Vanderbilt University, Nashville (M.V.); the Division of Allergy and Immunology, Cincinnati Children's Hospital, University of Cincinnati College of Medicine, Cincinnati (S.R.D., M.E.R.); and Pharma Data Associates, Piscataway, NJ (C.W.).""}, {'ForeName': 'Bhupinder', 'Initials': 'B', 'LastName': 'Singh', 'Affiliation': ""From the University of North Carolina, Chapel Hill (E.S.D.); the University of Utah, Salt Lake City (K.A.P.); Mayo Clinic Rochester, Rochester, MN (J.A.M., A.C.B.); the University of Pennsylvania Perelman School of Medicine, Philadelphia (G.W.F.); Northwestern University, Chicago (N.G., I.H.); the Icahn School of Medicine at Mount Sinai, New York (M.C.); Baylor College of Medicine, Houston (R.M.G.); Tufts University, Boston (J.L.); the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (P.K., A.D.K.); Ventura Clinical Trials, Ventura (S.H.), and Allakos, Redwood City (C.S., A.T.C., B.S., A.P.K., H.S.R.) - both in California; Vanderbilt University, Nashville (M.V.); the Division of Allergy and Immunology, Cincinnati Children's Hospital, University of Cincinnati College of Medicine, Cincinnati (S.R.D., M.E.R.); and Pharma Data Associates, Piscataway, NJ (C.W.).""}, {'ForeName': 'Amol P', 'Initials': 'AP', 'LastName': 'Kamboj', 'Affiliation': ""From the University of North Carolina, Chapel Hill (E.S.D.); the University of Utah, Salt Lake City (K.A.P.); Mayo Clinic Rochester, Rochester, MN (J.A.M., A.C.B.); the University of Pennsylvania Perelman School of Medicine, Philadelphia (G.W.F.); Northwestern University, Chicago (N.G., I.H.); the Icahn School of Medicine at Mount Sinai, New York (M.C.); Baylor College of Medicine, Houston (R.M.G.); Tufts University, Boston (J.L.); the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (P.K., A.D.K.); Ventura Clinical Trials, Ventura (S.H.), and Allakos, Redwood City (C.S., A.T.C., B.S., A.P.K., H.S.R.) - both in California; Vanderbilt University, Nashville (M.V.); the Division of Allergy and Immunology, Cincinnati Children's Hospital, University of Cincinnati College of Medicine, Cincinnati (S.R.D., M.E.R.); and Pharma Data Associates, Piscataway, NJ (C.W.).""}, {'ForeName': 'Henrik S', 'Initials': 'HS', 'LastName': 'Rasmussen', 'Affiliation': ""From the University of North Carolina, Chapel Hill (E.S.D.); the University of Utah, Salt Lake City (K.A.P.); Mayo Clinic Rochester, Rochester, MN (J.A.M., A.C.B.); the University of Pennsylvania Perelman School of Medicine, Philadelphia (G.W.F.); Northwestern University, Chicago (N.G., I.H.); the Icahn School of Medicine at Mount Sinai, New York (M.C.); Baylor College of Medicine, Houston (R.M.G.); Tufts University, Boston (J.L.); the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (P.K., A.D.K.); Ventura Clinical Trials, Ventura (S.H.), and Allakos, Redwood City (C.S., A.T.C., B.S., A.P.K., H.S.R.) - both in California; Vanderbilt University, Nashville (M.V.); the Division of Allergy and Immunology, Cincinnati Children's Hospital, University of Cincinnati College of Medicine, Cincinnati (S.R.D., M.E.R.); and Pharma Data Associates, Piscataway, NJ (C.W.).""}, {'ForeName': 'Marc E', 'Initials': 'ME', 'LastName': 'Rothenberg', 'Affiliation': ""From the University of North Carolina, Chapel Hill (E.S.D.); the University of Utah, Salt Lake City (K.A.P.); Mayo Clinic Rochester, Rochester, MN (J.A.M., A.C.B.); the University of Pennsylvania Perelman School of Medicine, Philadelphia (G.W.F.); Northwestern University, Chicago (N.G., I.H.); the Icahn School of Medicine at Mount Sinai, New York (M.C.); Baylor College of Medicine, Houston (R.M.G.); Tufts University, Boston (J.L.); the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (P.K., A.D.K.); Ventura Clinical Trials, Ventura (S.H.), and Allakos, Redwood City (C.S., A.T.C., B.S., A.P.K., H.S.R.) - both in California; Vanderbilt University, Nashville (M.V.); the Division of Allergy and Immunology, Cincinnati Children's Hospital, University of Cincinnati College of Medicine, Cincinnati (S.R.D., M.E.R.); and Pharma Data Associates, Piscataway, NJ (C.W.).""}, {'ForeName': 'Ikuo', 'Initials': 'I', 'LastName': 'Hirano', 'Affiliation': ""From the University of North Carolina, Chapel Hill (E.S.D.); the University of Utah, Salt Lake City (K.A.P.); Mayo Clinic Rochester, Rochester, MN (J.A.M., A.C.B.); the University of Pennsylvania Perelman School of Medicine, Philadelphia (G.W.F.); Northwestern University, Chicago (N.G., I.H.); the Icahn School of Medicine at Mount Sinai, New York (M.C.); Baylor College of Medicine, Houston (R.M.G.); Tufts University, Boston (J.L.); the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (P.K., A.D.K.); Ventura Clinical Trials, Ventura (S.H.), and Allakos, Redwood City (C.S., A.T.C., B.S., A.P.K., H.S.R.) - both in California; Vanderbilt University, Nashville (M.V.); the Division of Allergy and Immunology, Cincinnati Children's Hospital, University of Cincinnati College of Medicine, Cincinnati (S.R.D., M.E.R.); and Pharma Data Associates, Piscataway, NJ (C.W.).""}]",The New England journal of medicine,['10.1056/NEJMoa2012047']
2007,33085967,Ticagrelor alone vs. ticagrelor plus aspirin following percutaneous coronary intervention in patients with non-ST-segment elevation acute coronary syndromes: TWILIGHT-ACS.,"AIMS 


The aim of this study was to determine the effect of ticagrelor monotherapy on clinically relevant bleeding and major ischaemic events in relation to clinical presentation with and without non-ST elevation acute coronary syndromes (NSTE-ACS) among patients undergoing percutaneous coronary intervention (PCI) with drug-eluting stents (DES).
METHODS AND RESULTS 


We conducted a pre-specified subgroup analysis of The Ticagrelor With Aspirin or Alone in High Risk Patients After Coronary Intervention (TWILIGHT) trial, which enrolled 9006 patients with high-risk features undergoing PCI with DES. After 3 months of dual antiplatelet therapy (DAPT) with ticagrelor plus aspirin, 7119 adherent and event-free patients were randomized in a double-blind manner to ticagrelor plus placebo versus ticagrelor plus aspirin for 12 months. The primary outcome was Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding while the composite of all-cause death, myocardial infarction (MI), or stroke was the key secondary outcome. Among patients with NSTE-ACS (n = 4614), ticagrelor monotherapy reduced BARC 2, 3, or 5 bleeding by 53% [3.6% vs. 7.6%; hazard ratio (HR) 0.47; 95% confidence interval (CI) 0.36-0.61; P < 0.001) and in stable patients (n = 2503) by 24% (4.8% vs. 6.2%; HR 0.76; 95% CI 0.54-1.06; P = 0.11; nominal Pint = 0.03). Rates of all-cause death, MI, or stroke among those with (4.3% vs. 4.4%; HR 0.97; 95% CI 0.74-1.28; P = 0.84) and without (3.1% vs. 3.2%; HR 0.96; 95% CI 0.61-1.49; P = 0.85) NSTE-ACS were similar between treatment arms irrespective of clinical presentation (Pint = 0.96).
CONCLUSION 


Among patients with or without NSTE-ACS who have completed an initial 3-month course of DAPT following PCI with DES, ticagrelor monotherapy reduced clinically meaningful bleeding events without increasing ischaemic risk as compared with ticagrelor plus aspirin. The benefits of ticagrelor monotherapy with respect to bleeding events were more pronounced in patients with NSTE-ACS.
TRIAL REGISTRATION


Clinicaltrials.gov identifier: NCT02270242.",2020,"The benefits of ticagrelor monotherapy with respect to bleeding events were more pronounced in patients with NSTE-ACS.
","['patients undergoing percutaneous coronary intervention (PCI) with drug-eluting stents (DES', 'patients with or without NSTE-ACS', 'patients with non-ST-segment elevation acute coronary syndromes', 'High Risk Patients', '9006 patients with high-risk features undergoing PCI with DES', 'patients with NSTE-ACS']","['dual antiplatelet therapy (DAPT) with ticagrelor plus aspirin', 'ticagrelor plus aspirin', 'Ticagrelor With Aspirin', 'Coronary Intervention (TWILIGHT', 'ticagrelor plus placebo versus ticagrelor plus aspirin', 'ticagrelor monotherapy', 'Ticagrelor alone vs. ticagrelor plus aspirin']","['bleeding events', 'meaningful bleeding events', 'Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding while the composite of all-cause death, myocardial infarction (MI), or stroke', 'Rates of all-cause death, MI, or stroke']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}, {'cui': 'C0520886', 'cui_str': 'ST segment elevation'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C3160886', 'cui_str': 'Non ST segment elevation acute coronary syndrome'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]",9006.0,0.334593,"The benefits of ticagrelor monotherapy with respect to bleeding events were more pronounced in patients with NSTE-ACS.
","[{'ForeName': 'Usman', 'Initials': 'U', 'LastName': 'Baber', 'Affiliation': 'Department of Cardiology, The University of Oklahoma Health Sciences Center, Oklahoma City, OK 73104, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Dangas', 'Affiliation': 'Department of Cardiology, The Zena and Michael A. Wiener Cardiovascular Institute, Mount Sinai Hospital, One Gustave L. Levy Place, Box 1030, New York, NY 10029-6574, USA.'}, {'ForeName': 'Dominick Joseph', 'Initials': 'DJ', 'LastName': 'Angiolillo', 'Affiliation': 'Department of Cardiology, University of Florida-Shands, Jacksonville, FL 32218, USA.'}, {'ForeName': 'David Joel', 'Initials': 'DJ', 'LastName': 'Cohen', 'Affiliation': 'Department of Cardiology, University of Missouri-Kansas CIty, Kansas City, MO 64110, USA.'}, {'ForeName': 'Samin Kumar', 'Initials': 'SK', 'LastName': 'Sharma', 'Affiliation': 'Department of Cardiology, The Zena and Michael A. Wiener Cardiovascular Institute, Mount Sinai Hospital, One Gustave L. Levy Place, Box 1030, New York, NY 10029-6574, USA.'}, {'ForeName': 'Johny', 'Initials': 'J', 'LastName': 'Nicolas', 'Affiliation': 'Department of Cardiology, The Zena and Michael A. Wiener Cardiovascular Institute, Mount Sinai Hospital, One Gustave L. Levy Place, Box 1030, New York, NY 10029-6574, USA.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Briguori', 'Affiliation': 'Department of Cardiology, Clinica Mediterranea, 80122 Napoli NA, Italy.'}, {'ForeName': 'Jin Yu', 'Initials': 'JY', 'LastName': 'Cha', 'Affiliation': 'Department of Cardiology, The Zena and Michael A. Wiener Cardiovascular Institute, Mount Sinai Hospital, One Gustave L. Levy Place, Box 1030, New York, NY 10029-6574, USA.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Collier', 'Affiliation': 'Department of Cardiology, London School of Hygiene and Tropical Medicine, Keppel St, Bloomsbury, London WC1E 7HT, UK.'}, {'ForeName': 'Dariusz', 'Initials': 'D', 'LastName': 'Dudek', 'Affiliation': 'The 2nd Department of Cardiology Jagiellonian University Medical College, Swietej Anny 12, 31-008 Krakow, Poland.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Džavik', 'Affiliation': 'Department of Interventional Cardiology, Research and Innovation in Interventional Cardiology and Cardiac Intensive Care, Peter Munk Cardiac Centre, University Health Network, 200 Elizabeth St, Toronto, ON M5G 2CA, Canada.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Escaned', 'Affiliation': 'Department of Cardiology, Instituto de Investigacion Sanitaria del Hospital Clinico San Carlos and Complutense University, Calle del Prof Martin Lagos, s/n, 28040 Madrid, Spain.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Gil', 'Affiliation': 'Department of Invasive Cardiology, Center of Postgraduate Medical Education, Central Clinical Hospital of the Ministry of Interior and Administration, 137 Woloska Str, 02-507 Warsaw, Poland.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Gurbel', 'Affiliation': 'Department of Cardiology, Sinai Hospital of Baltimore System, Baltimore, MD 21215, USA.'}, {'ForeName': 'Christian W', 'Initials': 'CW', 'LastName': 'Hamm', 'Affiliation': 'Department of Cardiology, Kerckhoff Clinic, Benekestrabe 2-8, 61231 Bad Nauheim, Germany.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Henry', 'Affiliation': 'Department of Cardiology, The Carl and Edyth Lindner Center for Research and Education at the Christ Hospital, Cincinnati, OH 45219, USA.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Huber', 'Affiliation': 'Department of Cardiology, Wilhelminenhospital, Montleartstrabe 37, 1160 Wien, Austria.'}, {'ForeName': 'Adnan', 'Initials': 'A', 'LastName': 'Kastrati', 'Affiliation': 'Department of Cardiology, Deutsches Herzzentrum Munchen, Lazarettstrabe 36, 80636 Munchen, Germany.'}, {'ForeName': 'Upendra', 'Initials': 'U', 'LastName': 'Kaul', 'Affiliation': 'Department of Cardiology, Batra Hospital and Medical Research Centre, New Delhi 110062, India.'}, {'ForeName': 'Ran', 'Initials': 'R', 'LastName': 'Kornowski', 'Affiliation': 'Department of Cardiology, Rabin Medical Center, Zeev Jabutinsky Rd 39, Petach Tikva 49100, Israel.'}, {'ForeName': 'Mitchell', 'Initials': 'M', 'LastName': 'Krucoff', 'Affiliation': 'Department of Cardiology, Duke University Medical Center-Duke Clinical Research Institute, Durham, NC 27710, USA.'}, {'ForeName': 'Vijay', 'Initials': 'V', 'LastName': 'Kunadian', 'Affiliation': 'Department of Cardiology, Institute of Cellular Medicine, Faculty of Medical Sciences, Newcastle University, Freeman Road, High Heaton, NE7 7DN Newcastle upon Tyne, UK.'}, {'ForeName': 'Steven Owen', 'Initials': 'SO', 'LastName': 'Marx', 'Affiliation': 'Department of Cardiology, Columbia University Medical Center, New York, NY 10027, USA.'}, {'ForeName': 'Shamir', 'Initials': 'S', 'LastName': 'Mehta', 'Affiliation': 'Department of Cardiology, Hamilton Health Sciences, Hamilton, ON L8N 3Z5, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Moliterno', 'Affiliation': 'Department of Cardiology, University of Kentucky, Lexington, KY 40506, USA.'}, {'ForeName': 'Erik Magnus', 'Initials': 'EM', 'LastName': 'Ohman', 'Affiliation': 'Department of Cardiology, Duke University Medical Center-Duke Clinical Research Institute, Durham, NC 27710, USA.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Oldroyd', 'Affiliation': 'Department of Cardiology, The West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Agamemnon St, Clydebank G81 4DY, UK.'}, {'ForeName': 'Gennaro', 'Initials': 'G', 'LastName': 'Sardella', 'Affiliation': 'Department of Cardiology, Policlinico Umberto I University, 00161 Roma, Italy.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Sartori', 'Affiliation': 'Department of Cardiology, The Zena and Michael A. Wiener Cardiovascular Institute, Mount Sinai Hospital, One Gustave L. Levy Place, Box 1030, New York, NY 10029-6574, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Shlofmitz', 'Affiliation': 'Department of Cardiology, St. Francis Hospital, Roslyn, 100 Port Washington Blvd, Roslyn, NY 11576, USA.'}, {'ForeName': 'Philippe Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'Department of Cardiology, Groupe Hospitalier Bichat-Claude-Bernard, 46 Rue Henri Huchard, 75018 Paris, France.'}, {'ForeName': 'Giora', 'Initials': 'G', 'LastName': 'Weisz', 'Affiliation': 'Department of Cardiology, Montefiore Medical Center, The Bronx, NY 10467, USA.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Witzenbichler', 'Affiliation': 'Department of Cardiology, Helios Amper-Klinikum, Krankenhausstrabe 15, 85221 Dachau, Germany.'}, {'ForeName': 'Ya-Ling', 'Initials': 'YL', 'LastName': 'Han', 'Affiliation': 'Department of Cardiology, Shenyang North Hospital, Huanggu Qu, Shenyang Shi, Liaoning Sheng, China.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Pocock', 'Affiliation': 'Department of Cardiology, London School of Hygiene and Tropical Medicine, Keppel St, Bloomsbury, London WC1E 7HT, UK.'}, {'ForeName': 'Charles Michael', 'Initials': 'CM', 'LastName': 'Gibson', 'Affiliation': 'Department of Cardiology, Beth Israel Deaconess Medical Center, Boston, MA 02215, USA.'}, {'ForeName': 'Roxana', 'Initials': 'R', 'LastName': 'Mehran', 'Affiliation': 'Department of Cardiology, The Zena and Michael A. Wiener Cardiovascular Institute, Mount Sinai Hospital, One Gustave L. Levy Place, Box 1030, New York, NY 10029-6574, USA.'}]",European heart journal,['10.1093/eurheartj/ehaa670']
2008,33091586,Cognitive behavioral therapy for insomnia to enhance cognitive function and reduce the rate of Aβ deposition in older adults with symptoms of insomnia: A single-site randomized pilot clinical trial protocol.,"Lifestyle interventions to increase exercise and improve diet have been the focus of recent clinical trials to potentially prevent Alzheimer's disease (AD) [1,2]. However, despite the strong links between sleep disruptions, cognitive decline, and AD, sleep enhancement has yet to be targeted as a lifestyle intervention to prevent AD. A recent meta-analysis suggests that approximately 15% of AD may be prevented by an efficacious intervention aimed to reduce sleep disturbances and sleep disorders [3]. Chronic insomnia is the most frequent sleep disorder occurring in at least 40% of older adults [4]. Individuals with insomnia are more likely to be diagnosed with Alzheimer's Disease (AD) [5,6] and demonstrate decline in cognitive function [7] at long-term follow-up. AD is characterized by the accumulation of amyloid-β (Aβ) plaques and tau tangles in the brain, and growing evidence shows impaired sleep contributes to the accumulation of Aβ [8-10]. An intervention aimed at improving insomnia may be a critical opportunity for primary prevention to slow cognitive decline and potentially delay the onset of AD. Cognitive behavioral therapy for insomnia (CBT-I) is an efficacious treatment for insomnia [11-14], but the use of CBT-I to improve cognitive function and potentially reduce the rate of Aβ accumulation has never been examined. Therefore, the objective of the proposed study is to examine the efficacy of CBT-I on improving cognitive function in older adults with symptoms of insomnia. An exploratory aim is to assess the effect of CBT-I on rate of Aβ accumulation.",2020,Individuals with insomnia are more likely to be diagnosed with Alzheimer's Disease (AD),"[""Individuals with insomnia are more likely to be diagnosed with Alzheimer's Disease (AD"", 'older adults with symptoms of insomnia']","['CBT-I', 'Cognitive behavioral therapy']","['rate of Aβ deposition', 'Chronic insomnia', 'cognitive function']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}]","[{'cui': 'C0002716', 'cui_str': 'Amyloid Substance'}, {'cui': 'C0333562', 'cui_str': 'Deposition'}, {'cui': 'C0751249', 'cui_str': 'Chronic insomnia'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",,0.0637426,Individuals with insomnia are more likely to be diagnosed with Alzheimer's Disease (AD),"[{'ForeName': 'Catherine F', 'Initials': 'CF', 'LastName': 'Siengsukon', 'Affiliation': 'Department of Physical Therapy and Rehabilitation Science, University of Kansas Medical Center, Kansas City, KS, United States of America. Electronic address: csiengsukon@kumc.edu.'}, {'ForeName': 'Eryen', 'Initials': 'E', 'LastName': 'Nelson', 'Affiliation': 'Department of Physical Therapy and Rehabilitation Science, University of Kansas Medical Center, Kansas City, KS, United States of America.'}, {'ForeName': 'Cierra', 'Initials': 'C', 'LastName': 'Williams-Cooke', 'Affiliation': 'Department of Physical Therapy and Rehabilitation Science, University of Kansas Medical Center, Kansas City, KS, United States of America.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Ludwig', 'Affiliation': 'Department of Physical Therapy and Rehabilitation Science, University of Kansas Medical Center, Kansas City, KS, United States of America.'}, {'ForeName': 'Eber Silveira', 'Initials': 'ES', 'LastName': 'Beck', 'Affiliation': 'Department of Physical Therapy and Rehabilitation Science, University of Kansas Medical Center, Kansas City, KS, United States of America.'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Vidoni', 'Affiliation': ""University of Kansas Alzheimer's Disease Center, Fairway, KS, United States of America.""}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Mahnken', 'Affiliation': ""University of Kansas Alzheimer's Disease Center, Fairway, KS, United States of America; Department of Biostatistics & Data Science, University of Kansas Medical Center, Kansas City, KS, United States of America.""}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Stevens', 'Affiliation': 'Department of Neurology, University of Kansas Medical Center, Kansas City, KS, United States of America.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Drerup', 'Affiliation': 'Sleep Disorders Clinic, Cleveland Clinic, Cleveland, OH, United States of America.'}, {'ForeName': 'Jared', 'Initials': 'J', 'LastName': 'Bruce', 'Affiliation': 'Department of Biomedical and Health Informatics, University of Missouri - Kansas City School of Medicine, Kansas City, MO, United States of America.'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Burns', 'Affiliation': ""University of Kansas Alzheimer's Disease Center, Fairway, KS, United States of America.""}]",Contemporary clinical trials,['10.1016/j.cct.2020.106190']
2009,33091587,Safer use of antipsychotics in youth (SUAY) pragmatic trial protocol.,"BACKGROUND


Programs such as the Pediatric Access Line in Washington state have shown decreases in antipsychotic medication use by youth with non-psychotic disorders. Program outcomes have been studied with observational designs. This manuscript describes the protocol for Targeted and Safer Use of Antipsychotics in Youth (SUAY), a randomized controlled trial of psychiatrist review of prescriptions and facilitated access to psychosocial care. The aim of the intervention is to reduce the number of person-days of antipsychotic use among participants.
METHODS


Recruitment occurs at 4 health systems. Targeted enrollment is 800 youth aged 3-17 years. Clinicians are block randomized to intervention versus usual care prior to the study. Youth are nested within the arm of the prescribing clinician. Clinicians in the intervention group receive an EHR-based best practice alert with options to expedite access to psychosocial care and all medication orders are reviewed by a child and adolescent psychiatrist with feedback provided to the prescriber. The primary outcome is person-days of antipsychotic medication use in the 6 months following the initial order. All randomized individuals contribute data regardless of their level of participation (including declining all services).
DISCUSSION


The trial has been approved by the institutional review boards at each of the 4 sites. The intervention has 4 novel design features including automated recruitment using a best practice alert, psychiatrist medication order review and consultation, telephone navigation to psychosocial care, and telemental health visits. Recruitment began in March of 2018 and will be completed in June 2020. Follow-up will be completed December 31, 2020.
TRIAL REGISTRATION


Clinicaltrials.gov, NCT03448575.",2020,"The intervention has 4 novel design features including automated recruitment using a best practice alert, psychiatrist medication order review and consultation, telephone navigation to psychosocial care, and telemental health visits.","['Youth (SUAY', '800 youth aged 3-17\u202fyears', 'Recruitment occurs at 4 health systems', 'youth with non-psychotic disorders', 'participants']","['EHR-based best practice alert with options to expedite access to psychosocial care', 'antipsychotics']",['person-days of antipsychotic medication use'],"[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3179154', 'cui_str': 'Best Practices'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C1455743', 'cui_str': 'Psychosocial assessment'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",,0.0803332,"The intervention has 4 novel design features including automated recruitment using a best practice alert, psychiatrist medication order review and consultation, telephone navigation to psychosocial care, and telemental health visits.","[{'ForeName': 'Robert B', 'Initials': 'RB', 'LastName': 'Penfold', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA. Electronic address: Robert.B.Penfold@kp.org.'}, {'ForeName': 'Ella E', 'Initials': 'EE', 'LastName': 'Thompson', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Hilt', 'Affiliation': ""Seattle Children's Hospital, Seattle, WA, USA.""}, {'ForeName': 'Kelly J', 'Initials': 'KJ', 'LastName': 'Kelleher', 'Affiliation': ""Nationwide Children's Hospital, The Research Institute at Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Schwartz', 'Affiliation': ""Nationwide Children's Hospital, The Research Institute at Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Beck', 'Affiliation': 'Kaiser Permanente Colorado, Institute for Health Research, Denver, CO, USA.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Clarke', 'Affiliation': 'Kaiser Permanente Northwest, Portland, OR, USA.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Ralston', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA.'}, {'ForeName': 'Andrea L', 'Initials': 'AL', 'LastName': 'Hartzler', 'Affiliation': 'University of Washington, Seattle, WA, USA.'}, {'ForeName': 'R Yates', 'Initials': 'RY', 'LastName': 'Coley', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Akosile', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA.'}, {'ForeName': 'Benedetto', 'Initials': 'B', 'LastName': 'Vitiello', 'Affiliation': 'University of Turin, Turin, Italy.'}, {'ForeName': 'Gregory E', 'Initials': 'GE', 'LastName': 'Simon', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106184']
2010,33091589,Treatment of comorbid sleep disorders and posttraumatic stress disorder in active duty military: Design and methodology of a randomized clinical trial.,"Many individuals with posttraumatic stress disorder (PTSD) also suffer from insomnia and nightmares, which may be symptoms of PTSD or constitute partially independent comorbid disorders. Sleep disturbances are resistant to current treatments for PTSD, and those suffering from PTSD, insomnia, and nightmares have worse PTSD treatment outcomes. In addition, insomnia and nightmares are risk factors for depression, substance abuse, anxiety, and suicide. Cognitive-Behavioral Therapy for Insomnia and Nightmares (CBT-I&N) and Cognitive Processing Therapy (CPT) for PTSD are first line treatments of these conditions. CPT does not typically address insomnia or nightmares, and CBT-I&N does not typically address other symptoms of PTSD. There are limited scientific data on how best to provide these therapies to individuals suffering with all three disorders. This project aims to inform the most effective way to treat individuals suffering from PTSD, insomnia, and nightmares, potentially changing the standard of care. U.S. military personnel and recently discharged Veterans who served in support of combat operations following 9/11 aged 18-65 with PTSD, insomnia, and nightmares (N = 222) will be randomly assigned to one of the following 18-session individual treatment conditions delivered over 12-weeks: (1) 6 sessions of CBT-I&N followed by 12 sessions of CPT; (2) 12 sessions of CPT followed by 6 sessions of CBT-I&N; or (3) 12 sessions of CPT followed by an additional 6 sessions of CPT. All participants will be assessed at baseline, during treatment, and at 1-week, 1-month, 3-months, and 6-months posttreatment. The primary outcome will be PTSD symptom severity.",2020,Cognitive-Behavioral Therapy for Insomnia and Nightmares (CBT-I&N) and Cognitive Processing Therapy (CPT) for PTSD are first line treatments of these conditions.,"['individuals with posttraumatic stress disorder (PTSD', 'individuals suffering with all three disorders', 'comorbid sleep disorders and posttraumatic stress disorder in active duty military', 'U.S. military personnel and recently discharged Veterans who served in support of combat operations following 9/11 aged 18-65 with PTSD, insomnia, and nightmares (N\u202f=\u202f222']","['18-session individual treatment conditions delivered over 12-weeks', 'Cognitive-Behavioral Therapy', 'Cognitive Processing Therapy (CPT', 'CPT']","['Sleep disturbances', 'PTSD symptom severity']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0851578', 'cui_str': 'Sleep disorder'}, {'cui': 'C3831794', 'cui_str': 'Active duty military'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0028084', 'cui_str': 'Nightmares'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0025361', 'cui_str': 'Form of thinking'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}]",222.0,0.0167908,Cognitive-Behavioral Therapy for Insomnia and Nightmares (CBT-I&N) and Cognitive Processing Therapy (CPT) for PTSD are first line treatments of these conditions.,"[{'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Taylor', 'Affiliation': 'Department of Psychology, University of North Texas, 1155 Union Circle #311280, Denton, TX 76203-5017, USA; Behavioral Science Division, National Center for PTSD, VA Boston Healthcare System, 150 South Huntington Ave., Boston, MA 02130, USA. Electronic address: DanielJTaylor@arizona.edu.'}, {'ForeName': 'Kristi E', 'Initials': 'KE', 'LastName': 'Pruiksma', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, The University of Texas Health Science Center at San Antonio, 7703 Floyd Curl Dr., San Antonio, TX 78229, USA. Electronic address: Pruiksma@uthscsa.edu.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Mintz', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, The University of Texas Health Science Center at San Antonio, 7703 Floyd Curl Dr., San Antonio, TX 78229, USA. Electronic address: Mintz@uthscsa.edu.'}, {'ForeName': 'Danica C', 'Initials': 'DC', 'LastName': 'Slavish', 'Affiliation': 'Department of Psychology, University of North Texas, 1155 Union Circle #311280, Denton, TX 76203-5017, USA. Electronic address: Danica.Slavish@unt.edu.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Wardle-Pinkston', 'Affiliation': 'Department of Psychology, University of North Texas, 1155 Union Circle #311280, Denton, TX 76203-5017, USA. Electronic address: swpinkston@email.arizona.edu.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Tyler', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, The University of Texas Health Science Center at San Antonio, 7703 Floyd Curl Dr., San Antonio, TX 78229, USA. Electronic address: TylerH@uthscsa.edu.'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Dondanville', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, The University of Texas Health Science Center at San Antonio, 7703 Floyd Curl Dr., San Antonio, TX 78229, USA. Electronic address: Dondanville@uthscsa.edu.'}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Young-McCaughan', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, The University of Texas Health Science Center at San Antonio, 7703 Floyd Curl Dr., San Antonio, TX 78229, USA. Electronic address: Youngs1@uthscsa.edu.'}, {'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Scullin', 'Affiliation': 'Department of Psychology and Neuroscience, Baylor University, One Bear Place 97334, Waco, TX 76798, USA. Electronic address: Michael_Scullin@baylor.edu.'}, {'ForeName': 'Karin L', 'Initials': 'KL', 'LastName': 'Nicholson', 'Affiliation': 'Carl R. Darnall Army Medical Center, 36065 Santa Fe Ave., Fort Hood, TX 76544, USA. Electronic address: Karin.L.Nicholson.mil@mail.mil.'}, {'ForeName': 'Brett T', 'Initials': 'BT', 'LastName': 'Litz', 'Affiliation': 'Massachusetts Veterans Epidemiological Research and Information Center, VA Boston Healthcare System, 150 Hungtington Ave., Boston, MA 02130, USA; Department of Psychiatry, Boston University School of Medicine, 72 East Concord St., Boston, MA 02118, USA; Department of Psychological and Brain Sciences, Boston University, 64 Cummington Mall, Boston, MA 02215, USA. Electronic address: LitzB@bu.edu.'}, {'ForeName': 'Jessica R', 'Initials': 'JR', 'LastName': 'Dietch', 'Affiliation': 'Department of Psychology, University of North Texas, 1155 Union Circle #311280, Denton, TX 76203-5017, USA. Electronic address: Jessica.Dietch@va.gov.'}, {'ForeName': 'Douglas E', 'Initials': 'DE', 'LastName': 'Williamson', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, 1121 West Chapel Hill Street, Suite 201, Durham, NC 27701, USA; Durham VA Health Care System, Durham, NC, USA.'}, {'ForeName': 'Terence M', 'Initials': 'TM', 'LastName': 'Keane', 'Affiliation': 'Department of Psychiatry, Boston University School of Medicine, 72 East Concord St., Boston, MA 02118, USA; Durham VA Health Care System, Durham, NC, USA. Electronic address: Terry.Keane@va.gov.'}, {'ForeName': 'Alan L', 'Initials': 'AL', 'LastName': 'Peterson', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, The University of Texas Health Science Center at San Antonio, 7703 Floyd Curl Dr., San Antonio, TX 78229, USA; Research and Development Service, South Texas Veterans Health Care System, 7400 Merton Minter, San Antonio, TX 78229, USA; Department of Psychology, University of Texas at San Antonio, 1 UTSA Circle, San Antonio, TX 78249, USA. Electronic address: Petersona3@uthscsa.edu.'}, {'ForeName': 'Patricia A', 'Initials': 'PA', 'LastName': 'Resick', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, 1121 West Chapel Hill Street, Suite 201, Durham, NC 27701, USA. Electronic address: Patricia.Resick@duke.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Contemporary clinical trials,['10.1016/j.cct.2020.106186']
2011,33086160,An adaptive clinical trial design for cocaine use disorder: Extended-release amphetamine salts for early behavioral intervention non-responders.,"BACKGROUND/AIMS


Cocaine use disorder (CUD) persists as a major public health problem in the United States. Response to evidence-based behavioral treatment has been shown to be predicted by dopaminergic dysfunction. Amphetamine formulations modulate dopaminergic systems and are one of the few agents with positive clinical findings but are associated with unique risks. We aimed to find a model for determining the most appropriate patients for treatment with mixed amphetamine salts-extended-release (MAS-ER) for CUD using an adaptive trial design.
METHODS


We are enrolling treatment-seeking adults ages 18-60 years. All eligible participants receive bi-weekly individual counseling augmented with a computer-based intervention based on the community reinforcement approach with contingency management (CRA + CM) for 4 weeks. Participants who fail to achieve abstinence are additionally randomly assigned to 10 weeks of either MAS-ER, titrated up to 80 mg daily, or placebo. All participants complete a follow-up assessment after 12 weeks.
RESULTS


Frequency and amount of cocaine use, cravings, retention, and quality of life will be compared between groups. The primary outcome will be having at least 3 weeks of urine toxicology-confirmed self-reported abstinence. Analyses will also be conducted to identify variables that may help identify who is more or less likely respond to the behavioral intervention during the first 4-weeks of treatment.
CONCLUSIONS


This trial more closely mimics a personalized medicine approach that is often used in clinical practice. It will help us understand who may be appropriate for psychostimulant therapy as an enhancement to evidence-based behavioral interventions, while limiting exposure to those who would respond to a psychosocial intervention alone. ClinicalTrials.gov Identifier: NCT01986075.",2020,All eligible participants receive bi-weekly individual counseling augmented with a computer-based intervention based on the community reinforcement approach with contingency management (CRA + CM) for 4 weeks.,"['seeking adults ages 18-60\u202fyears', 'early behavioral intervention non-responders', 'Participants who fail to achieve abstinence']","['mixed amphetamine salts-extended-release (MAS-ER', 'bi-weekly individual counseling augmented with a computer-based intervention based on the community reinforcement approach with contingency management (CRA\u202f+\u202fCM', 'MAS-ER, titrated up to 80\u202fmg daily, or placebo', 'amphetamine salts', 'Amphetamine']","['cocaine use, cravings, retention, and quality of life', 'having at least 3\u202fweeks of urine toxicology-confirmed self-reported abstinence']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}]","[{'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0002658', 'cui_str': 'Amphetamine'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0035007', 'cui_str': 'Psychological Reinforcement'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0040541', 'cui_str': 'Toxicology'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}]",,0.173645,All eligible participants receive bi-weekly individual counseling augmented with a computer-based intervention based on the community reinforcement approach with contingency management (CRA + CM) for 4 weeks.,"[{'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Blevins', 'Affiliation': 'Department of Psychiatry, Columbia University Irving Medical Center, New York, NY, United States of America; Division on Substance Use Disorders, New York State Psychiatric Institute, New York, NY, United States of America. Electronic address: derek.blevins@nyspi.columbia.edu.'}, {'ForeName': 'Kenneth M', 'Initials': 'KM', 'LastName': 'Carpenter', 'Affiliation': 'Department of Psychiatry, Columbia University Irving Medical Center, New York, NY, United States of America; Division on Substance Use Disorders, New York State Psychiatric Institute, New York, NY, United States of America.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Martinez', 'Affiliation': 'Department of Psychiatry, Columbia University Irving Medical Center, New York, NY, United States of America; Division on Substance Use Disorders, New York State Psychiatric Institute, New York, NY, United States of America.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Mariani', 'Affiliation': 'Department of Psychiatry, Columbia University Irving Medical Center, New York, NY, United States of America; Division on Substance Use Disorders, New York State Psychiatric Institute, New York, NY, United States of America.'}, {'ForeName': 'Frances R', 'Initials': 'FR', 'LastName': 'Levin', 'Affiliation': 'Department of Psychiatry, Columbia University Irving Medical Center, New York, NY, United States of America; Division on Substance Use Disorders, New York State Psychiatric Institute, New York, NY, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106187']
2012,33086234,Unexpected interactions between dolutegravir and folate: randomised trial evidence from South Africa.,"OBJECTIVE


Dolutegravir exposure at conception was associated with a preliminary signal of increased infant neural tube defect (NTD) risk. As low maternal folate levels are linked with NTDs, we aimed to assess serum folate concentrations in women starting dolutegravir.
DESIGN


We analysed serum folate concentrations from stored plasma among women enrolled in the South African ADVANCE trial.
METHODS


We compared changes in mean serum folate and occurrence of low serum folate (<14.0 nmol/L) at weeks 0, 12 and 24 across study arms. In ADVANCE, 1,053 treatment-naïve participants were randomised to initiate tenofovir-alafenamide/emtricitabine + dolutegravir (TAF/FTC+DTG), tenofovir-disoproxil-fumarate (TDF)/FTC+DTG, or TDF/FTC/efavirenz (EFV).
RESULTS


Analysis includes 406 females, mean age 31.5 years and baseline CD4 count 356 cells/mm. At baseline, folate concentrations were similar across treatment arms. However, serum folate increased over 12 weeks in the TAF/FTC+DTG arm (+4.0 ± 8.1 nmol/L), while folate concentrations decreased slightly in the TDF/FTC+DTG arm (-1.8 ± 8.9 nmol/L) and decreased in the TDF/FTC/EFV arm (-5.9 ± 8.1 nmol/L). Women taking TDF/FTC/EFV had low folate concentrations at both 12 and 24 weeks compared with the other arms (p < 0.001). Of 26 women who became pregnant on study before week 24, folate concentrations increased between baseline and 12 weeks by a mean 2.4 ± 7.1 nmol/L in the TAF/FTC+DTG arm and 2.3 ± 8.4 nmol/L in the TDF/FTC+DTG arm, but decreased by -3.3 ± 8.1 with TDF/FTC/EFV arm.
CONCLUSIONS


Unexpectedly, no declines were noted in the dolutegravir-containing arms, and concentrations were considerably higher than in the efavirenz arm. The possibility that dolutegravir may block cellular uptake of folate warrants investigation.",2020,Women taking TDF/FTC/EFV had low folate concentrations at both 12 and 24 weeks compared with the other arms (p < 0.001).,"['26 women who became pregnant on study before week 24', 'women starting dolutegravir', '406 females, mean age 31.5 years and baseline CD4 count 356\u200acells/mm', '1,053 treatment-naïve participants', 'women enrolled in the South African ADVANCE trial']","['TAF/FTC+DTG', 'efavirenz', 'TDF/FTC+DTG', 'tenofovir-alafenamide/emtricitabine + dolutegravir (TAF/FTC+DTG), tenofovir-disoproxil-fumarate (TDF)/FTC+DTG, or TDF/FTC/efavirenz (EFV']","['low folate concentrations', 'mean serum folate and occurrence of low serum folate', 'folate concentrations', 'serum folate', 'serum folate concentrations']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C1450557', 'cui_str': 'IGFBP7 protein, human'}, {'cui': 'C0674428', 'cui_str': 'efavirenz'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C3713958', 'cui_str': 'tenofovir alafenamide'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}, {'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C0963398', 'cui_str': 'tenofovir disoproxil'}, {'cui': 'C0206682', 'cui_str': 'Follicular thyroid carcinoma'}]","[{'cui': 'C0239623', 'cui_str': 'Decreased folic acid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",1053.0,0.0787472,Women taking TDF/FTC/EFV had low folate concentrations at both 12 and 24 weeks compared with the other arms (p < 0.001).,"[{'ForeName': 'Nomathemba C', 'Initials': 'NC', 'LastName': 'Chandiwana', 'Affiliation': 'Ezintsha, Wits Reproductive Health and HIV Institute, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Chersich', 'Affiliation': 'Wits Reproductive Health and HIV Institute, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Willem Francois', 'Initials': 'WF', 'LastName': 'Venter', 'Affiliation': 'Ezintsha, Wits Reproductive Health and HIV Institute, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Godspower', 'Initials': 'G', 'LastName': 'Akpomiemie', 'Affiliation': 'Ezintsha, Wits Reproductive Health and HIV Institute, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Hill', 'Affiliation': 'Liverpool University, Pharmacology, Liverpool, United Kingdom.'}, {'ForeName': 'Bryony', 'Initials': 'B', 'LastName': 'Simmons', 'Affiliation': 'Department of Infectious Disease, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Shahin', 'Initials': 'S', 'LastName': 'Lockman', 'Affiliation': ""Brigham and Women's Hospital, Boston, USA.""}, {'ForeName': 'Celicia M', 'Initials': 'CM', 'LastName': 'Serenata', 'Affiliation': 'Ezintsha, Wits Reproductive Health and HIV Institute, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Fairlie', 'Affiliation': 'Wits Reproductive Health and HIV Institute, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Michelle A', 'Initials': 'MA', 'LastName': 'Moorhouse', 'Affiliation': 'Ezintsha, Wits Reproductive Health and HIV Institute, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}]","AIDS (London, England)",['10.1097/QAD.0000000000002741']
2013,33086238,"A Three-Way Crossover Study of Pregabalin, Placebo and the Histamine 3 Receptor Inverse Agonist AZD5213 in Combination with Pregabalin in Subjects with Painful Diabetic Neuropathy and Good Pain-Reporting Ability.","OBJECTIVES


In this study, patients with painful diabetic neuropathy (PDN) were trained using an experimental pain paradigm in an attempt to enroll a subset of patients who are ""pain connoisseurs"" and therefore more able to discriminate between active and placebo treatments.
METHODS


AZD5213, a novel histamine H3 receptor inverse agonist + pregabalin, pregabalin and placebo were then tested in a 3-period cross-over.
RESULTS


The study did not provide any evidence of clinical efficacy for AZD5213 when combined with pregabalin in the treatment of PDN.
DISCUSSION


The training of study subjects in pain reporting and subsequent enrichment with good pain reporters also did not enable the robust detection of efficacy of pregabalin relative to placebo in a small sample size. Further work is required before recommending the use of ""connoisseur"" subjects in future neuropathic pain studies.",2020,"The study did not provide any evidence of clinical efficacy for AZD5213 when combined with pregabalin in the treatment of PDN.
","['Subjects with Painful Diabetic Neuropathy and Good Pain-Reporting Ability', 'patients with painful diabetic neuropathy (PDN']","['experimental pain paradigm', 'pregabalin, pregabalin and placebo', 'Pregabalin, Placebo', 'pregabalin', 'placebo', 'Pregabalin', 'AZD5213']",[],"[{'cui': 'C0751074', 'cui_str': 'Neuralgia, Diabetic'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0657912', 'cui_str': 'pregabalin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.0859344,"The study did not provide any evidence of clinical efficacy for AZD5213 when combined with pregabalin in the treatment of PDN.
","[{'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Alexander', 'Affiliation': 'Takeda Pharmaceuticals International Co., 40 Landsdowne St.|Cambridge, MA| 02139.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Raudibaugh', 'Affiliation': ''}, {'ForeName': 'Egilius L H', 'Initials': 'ELH', 'LastName': 'Spierings', 'Affiliation': 'MedVadis Research Corporation, Waltham, MA.'}, {'ForeName': 'Nathaniel', 'Initials': 'N', 'LastName': 'Katz', 'Affiliation': 'WCG Analgesic Solutions, Wayland, MA.'}]",The Clinical journal of pain,['10.1097/AJP.0000000000000886']
2014,33086239,Greater Conditioned Pain Modulation Is Associated With Enhanced Morphine Analgesia in Healthy Individuals and Patients with Chronic Low Back Pain.,"OBJECTIVES


Conditioned pain modulation (CPM) protocols index magnitude of descending pain inhibition. This study evaluated whether degree of CPM, controlling for CPM expectancy confounds, was associated with analgesic and subjective responses to morphine, and whether chronic pain status or sex moderated these effects.
METHODS


Participants included 92 individuals with chronic low back pain (CLBP) and 99 healthy controls, none using daily opioid analgesics. In a crossover design, participants attended two identical laboratory sessions during which they received either intravenous morphine (0.08▒mg/kg) or saline placebo before undergoing evoked pain assessment. In each session, participants engaged in ischemic forearm and heat pain tasks, and a CPM protocol combining ischemic pain (conditioning stimulus) and heat pain (test stimulus). Placebo-controlled morphine outcomes were derived as differences in pain and subjective effects across drug conditions.
RESULTS


In hierarchical regressions controlling for CPM expectancies, greater placebo condition CPM was associated with less subjective morphine unpleasantness (P=0.001) and greater morphine analgesia (P's<0.05) on both the ischemic pain task (VAS Pain Intensity and Unpleasantness) and heat pain task (VAS Pain Intensity, McGill Pain Questionnaire-Sensory and Present Pain Intensity [PPI] subscales). There was no moderation by sex or CLBP status, except for the ischemic PPI outcome for which a significant 2-way interaction (P<0.05) was noted, with men showing a stronger positive relationship between CPM and morphine analgesia than women.
DISCUSSION


Result suggest that CPM might predict analgesic and subjective responses to opioid administration. Further evaluation of CPM as an element of precision pain medicine algorithms may be warranted.",2020,"In hierarchical regressions controlling for CPM expectancies, greater placebo condition CPM was associated with less subjective morphine unpleasantness (P=0.001) and greater morphine analgesia (P's<0.05) on both the ischemic pain task (VAS Pain Intensity and Unpleasantness) and heat pain task (VAS Pain Intensity, McGill Pain Questionnaire-Sensory and Present Pain Intensity [PPI] subscales).","['Healthy Individuals and Patients with Chronic Low Back Pain', 'Participants included 92 individuals with chronic low back pain (CLBP) and 99 healthy controls, none using daily opioid analgesics']","['saline placebo', 'intravenous morphine', 'Placebo-controlled morphine', 'morphine', 'CPM protocol combining ischemic pain (conditioning stimulus) and heat pain (test stimulus', 'Morphine Analgesia']","['pain and subjective effects', 'subjective morphine unpleasantness', 'ischemic pain task (VAS Pain Intensity and Unpleasantness) and heat pain task (VAS Pain Intensity, McGill Pain Questionnaire-Sensory and Present Pain Intensity [PPI] subscales', 'ischemic PPI outcome']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0445114', 'cui_str': 'None used'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}]","[{'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0024985', 'cui_str': 'McGill pain chart questionnaire'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",92.0,0.20887,"In hierarchical regressions controlling for CPM expectancies, greater placebo condition CPM was associated with less subjective morphine unpleasantness (P=0.001) and greater morphine analgesia (P's<0.05) on both the ischemic pain task (VAS Pain Intensity and Unpleasantness) and heat pain task (VAS Pain Intensity, McGill Pain Questionnaire-Sensory and Present Pain Intensity [PPI] subscales).","[{'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Bruehl', 'Affiliation': 'Department of Anesthesiology, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'France', 'Affiliation': 'Department of Psychology, Ohio University, Athens, OH, USA.'}, {'ForeName': 'Amanda L', 'Initials': 'AL', 'LastName': 'Stone', 'Affiliation': 'Department of Anesthesiology, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Rajnish', 'Initials': 'R', 'LastName': 'Gupta', 'Affiliation': 'Department of Anesthesiology, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Asokumar', 'Initials': 'A', 'LastName': 'Buvanendran', 'Affiliation': 'Department of Anesthesiology, Rush University, Chicago, IL, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Chont', 'Affiliation': 'Department of Anesthesiology, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Burns', 'Affiliation': 'Department of Behavioral Science, Rush University, Chicago, IL, USA.'}]",The Clinical journal of pain,['10.1097/AJP.0000000000000887']
2015,33086705,Effect of Dysphagia Rehabilitation Using Kinesiology Taping on Oropharyngeal Muscle Hypertrophy in Post-Stroke Patients: A Double Blind Randomized Placebo-Controlled Trial.,"BACKGROUND


It has recently been shown that suprahyoid muscle exercise using kinesiology taping (KT) increases the activation of the suprahyoid muscle in healthy adults, suggesting a potential therapeutic clinical exercise for dysphagia rehabilitation. This study investigated the effect of dysphagia rehabilitation using KT in stroke patients with dysphagia.
METHODS


Thirty subjects in South Korea were enrolled in this prospective placebo-controlled double-blind study. Participants were randomly assigned to the experimental and sham groups. In the experimental group, the tape was attached to the hyolaryngeal complex, pulled downward with approximately 70% tension, and then attached to the sternum and the clavicle bilaterally. In the sham group, the tape was applied similarly but without the tension. Both groups performed voluntary swallowing 50 times (10 times swallowing per set, times 5 sets) a day for 4 weeks with KT applied. Outcome measures were assessed using portable ultrasound equipment. The parameter measured was the change in thickness of the tongue muscle, mylohyoid muscle, and the anterior belly of the digastric muscle.
RESULTS


The experimental group showed statistically significant changes in the thickness of the tongue muscle, mylohyoid muscle, and anterior belly of the digastric muscle than the sham group ( p  = 0.007, 0.002, and 0.001).
CONCLUSION


Dysphagia rehabilitation using KT is a technique that may promote oropharyngeal muscle thickness in patients with dysphagia after stroke.",2020,"The experimental group showed statistically significant changes in the thickness of the tongue muscle, mylohyoid muscle, and anterior belly of the digastric muscle than the sham group ( p  = 0.007, 0.002, and 0.001).
","['Thirty subjects in South Korea', 'stroke patients with dysphagia', 'patients with dysphagia after stroke', 'Post-Stroke Patients', 'healthy adults']","['Dysphagia Rehabilitation Using Kinesiology Taping', 'suprahyoid muscle exercise using kinesiology taping (KT', 'placebo', 'dysphagia rehabilitation using KT', 'Placebo']","['thickness of the tongue muscle, mylohyoid muscle, and anterior belly of the digastric muscle', 'Oropharyngeal Muscle Hypertrophy']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C1744679', 'cui_str': 'Structure of suprahyoid muscle'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0040408', 'cui_str': 'Tongue structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0224159', 'cui_str': 'Structure of mylohyoid muscle'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0224086', 'cui_str': 'Belly of skeletal muscle'}, {'cui': 'C0224155', 'cui_str': 'Digastric muscle structure'}, {'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C0236033', 'cui_str': 'Muscle hypertrophy'}]",,0.0952411,"The experimental group showed statistically significant changes in the thickness of the tongue muscle, mylohyoid muscle, and anterior belly of the digastric muscle than the sham group ( p  = 0.007, 0.002, and 0.001).
","[{'ForeName': 'Young-Jin', 'Initials': 'YJ', 'LastName': 'Jung', 'Affiliation': 'Department of Radiological Science at Health Sciences Division, DongSeo University, 47 Jurye-ro, Sasang-gu, Busan 47011, Korea.'}, {'ForeName': 'Hee-Jeong', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Department of Occuptional Therapy, Kyungdong University, 815, Gyeonhwon-ro, Munmak-eup, Wonju, Gangwon-do 26495, Korea.'}, {'ForeName': 'Jong-Bae', 'Initials': 'JB', 'LastName': 'Choi', 'Affiliation': 'Department of Occupational Therapy, Sangji University, 83, Sangjidae-gil, Wonju, Gangwon-do 26339, Korea.'}, {'ForeName': 'Ji-Su', 'Initials': 'JS', 'LastName': 'Park', 'Affiliation': 'Advanced Human Resource Development Project Group for Health Care in Aging Friendly Industry, Dongseo University, 47 Jurye-ro, Sasang-gu, Busan 47011, Korea.'}, {'ForeName': 'Na-Kyoung', 'Initials': 'NK', 'LastName': 'Hwang', 'Affiliation': 'Department of Occupational Therapy, Seoul North Municipal Hospital, 38 Yangwonyeokro, Jungnang-gu, Seoul 02062, Korea.'}]","Healthcare (Basel, Switzerland)",['10.3390/healthcare8040411']
2016,33086749,Safety and Stability of Pulmonary Function in Patients with Decreased Respiratory Function Treated for Spasticity with OnabotulinumtoxinA.,"Two randomized, placebo-controlled studies evaluated the pulmonary function safety of onabotulinumtoxinA (onabotA) for treatment of upper and/or lower limb spasticity. Patients with stable baseline respiratory status received one or two treatments with placebo, 240 U, or 360 U of onabotA. Pulmonary function tests, adverse events, and efficacy were measured at least every 6 weeks for 18 weeks (Study 1) or 30 weeks (Study 2). Study 1 enrolled 109 patients ( n  = 36-37/group) and Study 2 enrolled 155 patients ( n  = 48-54/group). Mean baseline forced vital capacity (FVC) was 76-78% of predicted per group in Study 1 and 71% of predicted per group in Study 2. In Study 1, change from baseline FVC values were significantly ( p  < 0.05) decreased vs. placebo at weeks 3 (240 U -57 mL vs. placebo +110 mL) and 12 (360 U -6 mL vs. +167 mL placebo). In Study 2, change from baseline FVC values were significantly decreased in the 360 U group vs. placebo at weeks 6 (-78 mL vs. +49 mL placebo), 13 (-60 mL vs. +119 mL placebo), 18 (-128 mL vs. +80 mL placebo), and 24 (-82 mL vs. +149 mL placebo). Individual pulmonary function-related adverse events were not correlated with PFT decreases. The most frequent pulmonary-related adverse events were nasopharyngitis (Study 1) and upper respiratory tract infection (Study 2). Ashworth scores were significantly improved at multiple time points in both studies. Injection of onabotA for spasticity in patients with decreased pulmonary function, at single and repeated doses of up to 360 U, was associated with small but statistically significant decreases in FVC or forced expiratory volume 1 s (FEV1) (>12% and 200 mL) that were subclinical and not correlated with any adverse clinical pulmonary events.",2020,"In Study 1, change from baseline FVC values were significantly ( p  < 0.05) decreased vs. placebo at weeks 3","['Patients with Decreased Respiratory Function Treated for Spasticity with OnabotulinumtoxinA', 'Study 1 enrolled 109 patients ( n  = 36-37/group) and Study 2 enrolled 155 patients ( n  = 48-54/group', 'upper and/or lower limb spasticity', 'Patients with stable baseline respiratory status']","['placebo', 'onabotulinumtoxinA (onabotA']","['baseline FVC values', 'pulmonary function', 'Individual pulmonary function-related adverse events', 'Safety and Stability of Pulmonary Function', 'Mean baseline forced vital capacity (FVC', 'FVC or forced expiratory volume 1 s (FEV1']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C0026838', 'cui_str': 'Spasticity'}, {'cui': 'C2719767', 'cui_str': 'OnabotulinumtoxinA'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C1271100', 'cui_str': 'Lower limb spasticity'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0449438', 'cui_str': 'Status'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2719767', 'cui_str': 'OnabotulinumtoxinA'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C3714541', 'cui_str': 'Forced vital capacity'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}]",,0.315781,"In Study 1, change from baseline FVC values were significantly ( p  < 0.05) decreased vs. placebo at weeks 3","[{'ForeName': 'Ziyad', 'Initials': 'Z', 'LastName': 'Ayyoub', 'Affiliation': 'Rancho Los Amigos National Rehabilitation Center, Downey, CA 90242, USA.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Brashear', 'Affiliation': 'Department of Neurology, University of California, Sacramento, CA 95817, USA.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Banach', 'Affiliation': 'Department of Neurology, Jagiellonian University, 31-007 Krakow, Poland.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Schoene', 'Affiliation': 'Sound Physicians, San Francisco, CA 95116, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Stringer', 'Affiliation': 'Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Torrance, CA 90502, USA.'}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Boodhoo', 'Affiliation': 'Allergan plc, an AbbVie Company, Irvine, CA 92612, USA.'}, {'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Yushmanova', 'Affiliation': 'Allergan plc, an AbbVie Company, Irvine, CA 92612, USA.'}, {'ForeName': 'Rozalina', 'Initials': 'R', 'LastName': 'Dimitrova', 'Affiliation': 'Allergan plc, an AbbVie Company, Irvine, CA 92612, USA.'}, {'ForeName': 'Mitchell F', 'Initials': 'MF', 'LastName': 'Brin', 'Affiliation': 'Allergan plc, an AbbVie Company, Irvine, CA 92612, USA.'}]",Toxins,['10.3390/toxins12100661']
2017,33087047,The use of intravenous immunoglobulin gamma for the treatment of severe coronavirus disease 2019: a randomized placebo-controlled double-blind clinical trial.,"BACKGROUND


Coronavirus disease 2019 (COVID-19) has infected people in many countries worldwide. Discovering an effective treatment for this disease, particularly in severe cases, has become the subject of intense scientific investigation. Therefore, the objective of this study was to evaluate the efficacy of intravenous immunoglobulin (IVIg) in patients with severe COVID-19 infection.
METHODS


This study was conducted as a randomized placebo-controlled double-blind clinical trial. Fifty-nine patients with severe COVID-19 infection who did not respond to initial treatments were randomly assigned into two groups. One group received IVIg (human)-four vials daily for 3 days (in addition to initial treatment), while the other group received a placebo. Patients' demographic, clinical, and select laboratory test results, as well as the occurrence of in-hospital mortality, were recorded.
RESULTS


Among total study subjects, 30 patients received IVIg and 29 patients received a placebo. Demographics, clinical characteristics, and laboratory tests were not statistically different (P > 0.05) between the two groups. The in-hospital mortality rate was significantly lower in the IVIg group compared to the control group (6 [20.0%] vs. 14 [48.3%], respectively; P = 0.022). Multivariate regression analysis demonstrated that administration of IVIg did indeed have a significant impact on mortality rate (aOR = 0.003 [95% CI: 0.001-0.815]; P = 0.042).
CONCLUSIONS


Our study demonstrated that the administration of IVIg in patients with severe COVID-19 infection who did not respond to initial treatment could improve their clinical outcome and significantly reduce mortality rate. Further multicenter studies with larger sample sizes are nonetheless required to confirm the appropriateness of this medication as a standard treatment.
TRIAL REGISTRATION


A study protocol was registered at the Iranian Registry of Clinical Trials ( www.IRCT.ir ), number IRCT20200501047259N1 . It was registered retrospectively on May 17th, 2020.",2020,"Demographics, clinical characteristics, and laboratory tests were not statistically different (P > 0.05) between the two groups.","['patients with severe COVID-19 infection', 'severe coronavirus disease 2019', 'Fifty-nine patients with severe COVID-19 infection who did not respond to initial treatments']","['IVIg (human)-four vials daily', 'placebo', 'intravenous immunoglobulin gamma', 'intravenous immunoglobulin (IVIg']","['mortality rate', 'hospital mortality rate', 'occurrence of in-hospital mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C3830128', 'cui_str': '59'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0085297', 'cui_str': 'Intravenous Immunoglobulins'}, {'cui': 'C1706398', 'cui_str': 'Vial - unit of product usage'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0017011', 'cui_str': 'Gamma radiation'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}]",59.0,0.545188,"Demographics, clinical characteristics, and laboratory tests were not statistically different (P > 0.05) between the two groups.","[{'ForeName': 'Naser', 'Initials': 'N', 'LastName': 'Gharebaghi', 'Affiliation': 'Department of Infectious Diseases, Urmia University of Medical Sciences, Urmia, Iran.'}, {'ForeName': 'Rahim', 'Initials': 'R', 'LastName': 'Nejadrahim', 'Affiliation': 'Department of Infectious Diseases, Urmia University of Medical Sciences, Urmia, Iran.'}, {'ForeName': 'Seyed Jalil', 'Initials': 'SJ', 'LastName': 'Mousavi', 'Affiliation': 'Department of Infectious Diseases, Urmia University of Medical Sciences, Urmia, Iran.'}, {'ForeName': 'Seyyed-Reza', 'Initials': 'SR', 'LastName': 'Sadat-Ebrahimi', 'Affiliation': 'Cardiovascular Research Center, Tabriz University of Medical Sciences, Tabriz, Iran. Sadatr@tbzmed.ac.ir.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Hajizadeh', 'Affiliation': 'Department of Cardiology, Urmia University of Medical Sciences, Urmia, Iran. hajizadh.reza@gmail.com.'}]",BMC infectious diseases,['10.1186/s12879-020-05507-4']
2018,33087054,"Improving knowledge, self-efficacy and collective efficacy regarding the Brazilian dietary guidelines in primary health care professionals: a community controlled trial.","BACKGROUND


Capacity-building of health professionals regarding to nutrition is a strategy for qualifying public health work to promote healthy diets in primary health care (PHC) services.
OBJECTIVE


To evaluate the effect of an intervention based on Brazilian Dietary Guidelines (BDG) on the knowledge, self-efficacy (SE) and collective efficacy (CE) of interprofessional teams working in PHC.
METHODS


It refers to a pre-post intervention study involving 24 health professionals divided into a control group (CG) and intervention (IG). The IG received a 16-h educational workshop on the BDG, guided by a validated protocol. Knowledge, SE and CE for using the BDG were assessed via a self-administered scale, ranging from 0 to 16 and 0 to 36 points, respectively; the scale was previously validated, completed before and after 2 months of the intervention. The effects of the intervention were estimated by paired t-test for intragroup comparisons over time.
RESULTS


The mean difference in the knowledge and SE scores of the IG pre- and post-intervention was 2.0 (CI 0.49-3.51) and 6.75 (CI 4.05-9.45) points, respectively. These results means the IG participants obtained 59 and 52.8% more points in knowledge and in SE in relation to CG, with significative difference (p = 0.007 and p <  0.00, respectively). There was no significant variation in the CE scores in both groups.
CONCLUSIONS


Considering the results presented and due to the originality of the study in question, the educational workshop was effective in increasing the knowledge and SE of professionals working in PHC in using the Dietary Guidelines in their work routines. These findings can assist other research in developing nutrition interventions with interprofessional teams.",2020,"There was no significant variation in the CE scores in both groups.
","['24 health professionals divided into a', 'primary health care professionals']","['Brazilian Dietary Guidelines (BDG', 'Brazilian dietary guidelines', '16-h educational workshop', 'control group (CG) and intervention (IG']","['knowledge, self-efficacy (SE) and collective efficacy (CE', 'knowledge and SE scores', 'CE scores', 'Improving knowledge, self-efficacy and collective efficacy']","[{'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C3658297', 'cui_str': 'Dietary Guidelines'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",24.0,0.0252014,"There was no significant variation in the CE scores in both groups.
","[{'ForeName': 'C R', 'Initials': 'CR', 'LastName': 'Tramontt', 'Affiliation': 'Nutrition in Public Health Postgraduate Program, School of Public Health, University of São Paulo, Av. Dr. Arnaldo 715, São Paulo, SP, 01246-904, Brazil. claudiartramontt@gmail.com.'}, {'ForeName': 'P C', 'Initials': 'PC', 'LastName': 'Jaime', 'Affiliation': 'Department of Nutrition, School of Public Health, University of São Paulo, Av. Dr. Arnaldo 715, São Paulo, SP, 01246-904, Brazil.'}]",BMC family practice,['10.1186/s12875-020-01245-3']
2019,33087083,The effects of financial incentives on diabetes prevention program attendance and weight loss among low-income patients: the We Can Prevent Diabetes cluster-randomized controlled trial.,"BACKGROUND


Penetration and participation of real life implementation of lifestyle change programs to prevent type 2 diabetes has been challenging. This is particularly so among low income individuals in the United States. The purpose of this study is to examine the effectiveness of financial incentives on attendance and weight loss among Medicaid beneficiaries participating in the 12-month Diabetes Prevention Program (DPP).
METHODS


This is a cluster-randomized controlled trial with two financial incentive study arms and an attention control study arm. Medicaid beneficiaries with prediabetes from 13 primary care clinics were randomly assigned to individually earned incentives (IND; 33 groups; n = 309), a hybrid of individual- and group-earned incentives (GRP; 30 groups; n = 259), and an attention control (AC; 30 groups; n = 279). Up to $520 in incentives could be earned for attaining attendance and weight loss goals over 12 months. Outcomes are percent weight loss from baseline, achieving 5% weight loss from baseline, and attending 75% of core and 75% of maintenance DPP sessions. Linear mixed models were used to examine weight change and attendance rates over the 16 weeks and 12 months.
RESULTS


The percent weight change at 16 weeks for the IND, GRP, and AC participants were similar, at - 2.6, - 3.1%, and - 3.4%, respectively. However, participants achieving 5% weight loss in the IND, GRP, and AC groups was 21.5, 24.0% (GRP vs AC, P < 0.05), and 15.2%. Attendance at 75% of the DPP core sessions was significantly higher among IND (60.8%, P < 0.001) and GRP (64.0%, P < 0.001) participants than among AC (38.6%) participants. Despite substantial attrition over time, attendance at 75% of the DPP maintenance sessions was also significantly higher among IND (23.0%, P < 0.001) and GRP (26.1%, P < 0.001) participants than among AC (11.0%) participants.
CONCLUSIONS


Financial incentives can improve the proportion of Medicaid beneficiaries attending the 12-month DPP and achieving at least 5% weight loss.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02422420 ; retrospectively registered April 21, 2015.",2020,"Attendance at 75% of the DPP core sessions was significantly higher among IND (60.8%, P < 0.001) and GRP (64.0%, P < 0.001) participants than among AC (38.6%) participants.","['low-income patients', 'Medicaid beneficiaries participating in the 12-month Diabetes Prevention Program (DPP', 'Medicaid beneficiaries with prediabetes from 13 primary care clinics']","['financial incentives', 'hybrid of individual- and group-earned incentives (GRP; 30 groups; n\xa0=\u2009259), and an attention control (AC']","['Attendance', 'weight loss', 'attendance and weight loss', 'percent weight change', 'GRP', 'percent weight loss', 'weight change and attendance rates']","[{'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025071', 'cui_str': 'Medicaid coverage'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}]","[{'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0061132', 'cui_str': 'Gastrin-releasing peptide'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0061132', 'cui_str': 'Gastrin-releasing peptide'}]",2.0,0.114787,"Attendance at 75% of the DPP core sessions was significantly higher among IND (60.8%, P < 0.001) and GRP (64.0%, P < 0.001) participants than among AC (38.6%) participants.","[{'ForeName': 'Jay R', 'Initials': 'JR', 'LastName': 'Desai', 'Affiliation': 'HealthPartners Institute, Bloomington, MN, USA. Jay.Desai@state.mn.us.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Vazquez-Benitez', 'Affiliation': 'HealthPartners Institute, Bloomington, MN, USA.'}, {'ForeName': 'Gretchen', 'Initials': 'G', 'LastName': 'Taylor', 'Affiliation': 'Minnesota Department of Health, 85 East 7th Place, P.O. Box 64882, St. Paul, MN, 55164, USA.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Johnson', 'Affiliation': 'Minnesota Department of Health, 85 East 7th Place, P.O. Box 64882, St. Paul, MN, 55164, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Anderson', 'Affiliation': 'Minnesota Department of Health, 85 East 7th Place, P.O. Box 64882, St. Paul, MN, 55164, USA.'}, {'ForeName': 'Joyce E', 'Initials': 'JE', 'LastName': 'Garrett', 'Affiliation': 'Minnesota Department of Human Services, St. Paul, MN, USA.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Gilmer', 'Affiliation': 'University of California, La Jolla, San Diego, CA, USA.'}, {'ForeName': 'Houa', 'Initials': 'H', 'LastName': 'Vue-Her', 'Affiliation': 'Minnesota Department of Health, 85 East 7th Place, P.O. Box 64882, St. Paul, MN, 55164, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Rinn', 'Affiliation': 'Minnesota Department of Human Services, St. Paul, MN, USA.'}, {'ForeName': 'Katelyn', 'Initials': 'K', 'LastName': 'Engel', 'Affiliation': 'National Kidney Foundation, New York, NY, USA.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Schiff', 'Affiliation': 'Minnesota Department of Human Services, St. Paul, MN, USA.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': ""O'Connor"", 'Affiliation': 'HealthPartners Institute, Bloomington, MN, USA.'}]",BMC public health,['10.1186/s12889-020-09683-5']
2020,33087100,"The effect of infliximab in patients with chronic low back pain and Modic changes (the BackToBasic study): study protocol of a randomized, double blind, placebo-controlled, multicenter trial.","BACKGROUND


Low back pain is common and a significant number of patients experience chronic low back pain. Current treatment options offer small to moderate effects. Patients with vertebral bone marrow lesions visualized as Modic changes on magnetic resonance imaging may represent a subgroup within the low back pain population. There is evidence for inflammatory mediators being involved in development of Modic changes; hence, suppression of inflammation could be a treatment strategy for these patients. This study examines the effect of anti-inflammatory treatment with the TNF-α inhibitor infliximab in patients with chronic low back pain and Modic changes.
METHODS/DESIGN


The BackToBasic trial is a multicenter, double blind, randomized controlled trial conducted at six hospitals in Norway, comparing intravenous infusions with infliximab with placebo. One hundred twenty-six patients aged 18-65 with chronic low back pain and type 1 Modic changes will be recruited from secondary care outpatients' clinics. The primary outcome is back pain-specific disability at day 154 (5 months). The study is designed to detect a difference in change of 10 (SD 18) in the Oswestry Disability Index at day 154/ 5 months. The study also aims to refine MRI-assessment, investigate safety and cost-effectiveness and explore the underlying biological mechanisms of Modic changes.
DISCUSSION


Finding treatments that target underlying mechanisms could pose new treatment options for patients with low back pain. Suppression of inflammation could be a treatment strategy for patients with low back pain and Modic changes. This paper presents the design of the BackToBasic study, where we will assess the effect of an anti-inflammatory treatment versus placebo in patients with chronic low back pain and type 1 Modic changes. The study is registered at ClinicalTrials.gov under the identifier NCT03704363 . The EudraCT Number: 2017-004861-29.",2020,The study is designed to detect a difference in change of 10 (SD 18) in the Oswestry Disability Index at day 154/ 5 months.,"['patients with chronic low back pain and Modic changes (the BackToBasic study', 'patients with chronic low back pain and type 1 Modic changes', 'patients with low back pain', ""One hundred twenty-six patients aged 18-65 with chronic low back pain and type 1 Modic changes will be recruited from secondary care outpatients' clinics"", 'patients with low back pain and Modic changes', 'patients experience chronic low back pain', 'patients with chronic low back pain and Modic changes', 'six hospitals in Norway, comparing intravenous infusions with', 'Patients with vertebral bone marrow lesions']","['infliximab', 'infliximab with placebo', 'placebo', 'TNF-α inhibitor infliximab']","['safety and cost-effectiveness', 'Oswestry Disability Index', 'back pain-specific disability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3494402', 'cui_str': 'Secondary Care'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0028423', 'cui_str': 'Norway'}, {'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}, {'cui': 'C0229622', 'cui_str': 'Structure of bone marrow of vertebral body'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]","[{'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0231170', 'cui_str': 'Disability'}]",126.0,0.512019,The study is designed to detect a difference in change of 10 (SD 18) in the Oswestry Disability Index at day 154/ 5 months.,"[{'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Gjefsen', 'Affiliation': 'Research and Communication Unit for Musculoskeletal Health (FORMI), Oslo University Hospital HF, Ulleval, Bygg 37b, P.O. Box 4956 Nydalen, 0424, Oslo, Norway. e.gjefsen@gmail.com.'}, {'ForeName': 'Lars Christian Haugli', 'Initials': 'LCH', 'LastName': 'Bråten', 'Affiliation': 'Research and Communication Unit for Musculoskeletal Health (FORMI), Oslo University Hospital HF, Ulleval, Bygg 37b, P.O. Box 4956 Nydalen, 0424, Oslo, Norway.'}, {'ForeName': 'Guro Løvik', 'Initials': 'GL', 'LastName': 'Goll', 'Affiliation': 'Department of Rheumatology, Diakonhjemmet Hospital, Box 23 Vinderen, 0319, Oslo, Norway.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Wigemyr', 'Affiliation': 'Department of Research and Innovation, Division of Clinical Neuroscience, Oslo University Hospital, P.O. Box 4956 Nydalen, 0424, Oslo, Norway.'}, {'ForeName': 'Nils', 'Initials': 'N', 'LastName': 'Bolstad', 'Affiliation': 'Department of Medical Biochemistry, Oslo University Hospital, Radiumhospitalet, Box 4953 Nydalen, 0424, Oslo, Norway.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Valberg', 'Affiliation': 'Oslo Centre for Biostatistics and Epidemiology, Oslo University Hospital, Sogn Arena 3.etg, P.O.Box 4950 Nydalen, Oslo, Norway.'}, {'ForeName': 'Elina Iordanova', 'Initials': 'EI', 'LastName': 'Schistad', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Oslo University Hospital HF, P.O. Box 4956 Nydalen, 0424, Oslo, Norway.'}, {'ForeName': 'Gunn Hege', 'Initials': 'GH', 'LastName': 'Marchand', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, St. Olavs Hospital, Trondheim University Hospital, P.O. Box 3250 Torgarden, NO-7006, Trondheim, Norway.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Granviken', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, St. Olavs Hospital, Trondheim University Hospital, P.O. Box 3250 Torgarden, NO-7006, Trondheim, Norway.'}, {'ForeName': 'Kaja Kristine', 'Initials': 'KK', 'LastName': 'Selmer', 'Affiliation': 'Department of Research and Innovation, Division of Clinical Neuroscience, Oslo University Hospital, P.O. Box 4956 Nydalen, 0424, Oslo, Norway.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Froholdt', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Drammen Hospital, Vestre Viken Hospital Trust Drammen, P.O. Box 800, 3004, Drammen, Norway.'}, {'ForeName': 'Anne Julsrud', 'Initials': 'AJ', 'LastName': 'Haugen', 'Affiliation': 'Department of Rheumatology, Østfold Hospital Trust, P.O. Box 300, 1714 Grålum, Moss, Norway.'}, {'ForeName': 'Magnhild Hammersland', 'Initials': 'MH', 'LastName': 'Dagestad', 'Affiliation': 'Department of Radiology, Haukeland University Hospital, Jonas Liesvei 65, 5021, Bergen, Norway.'}, {'ForeName': 'Nils', 'Initials': 'N', 'LastName': 'Vetti', 'Affiliation': 'Department of Radiology, Haukeland University Hospital, Jonas Liesvei 65, 5021, Bergen, Norway.'}, {'ForeName': 'Gunnstein', 'Initials': 'G', 'LastName': 'Bakland', 'Affiliation': 'Department of Rheumatology, University Hospital of North Norway, P.O. Box 100, 9038, Tromsø, Norway.'}, {'ForeName': 'Benedicte Alexandra', 'Initials': 'BA', 'LastName': 'Lie', 'Affiliation': 'Department of Medical Genetics, University of Oslo and Oslo University Hospital, P.O. Box 4956 Nydalen, 0424, Oslo, Norway.'}, {'ForeName': 'Espen A', 'Initials': 'EA', 'LastName': 'Haavardsholm', 'Affiliation': 'Department of Rheumatology, Diakonhjemmet Hospital, Box 23 Vinderen, 0319, Oslo, Norway.'}, {'ForeName': 'Aksel Thuv', 'Initials': 'AT', 'LastName': 'Nilsen', 'Affiliation': 'Department of Rheumatology, University Hospital of North Norway, P.O. Box 100, 9038, Tromsø, Norway.'}, {'ForeName': 'Thor Einar', 'Initials': 'TE', 'LastName': 'Holmgard', 'Affiliation': 'Norwegian Back Pain Association, P.O.Box 9612 Fjellhagen, 3065, Drammen, Norway.'}, {'ForeName': 'Thomas Istvan', 'Initials': 'TI', 'LastName': 'Kadar', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Haukeland University Hospital, Helse Bergen HF, Box 1, 5021, Bergen, Norway.'}, {'ForeName': 'Tore', 'Initials': 'T', 'LastName': 'Kvien', 'Affiliation': 'Faculty of Medicine, University of Oslo, P.O. Box 1072 Blindern, 0316, Oslo, Norway.'}, {'ForeName': 'Jan Sture', 'Initials': 'JS', 'LastName': 'Skouen', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Haukeland University Hospital, Helse Bergen HF, Box 1, 5021, Bergen, Norway.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Grøvle', 'Affiliation': 'Department of Rheumatology, Østfold Hospital Trust, P.O. Box 300, 1714 Grålum, Moss, Norway.'}, {'ForeName': 'Jens Ivar', 'Initials': 'JI', 'LastName': 'Brox', 'Affiliation': 'Faculty of Medicine, University of Oslo, P.O. Box 1072 Blindern, 0316, Oslo, Norway.'}, {'ForeName': 'Ansgar', 'Initials': 'A', 'LastName': 'Espeland', 'Affiliation': 'Department of Radiology, Haukeland University Hospital, Jonas Liesvei 65, 5021, Bergen, Norway.'}, {'ForeName': 'Kjersti', 'Initials': 'K', 'LastName': 'Storheim', 'Affiliation': 'Research and Communication Unit for Musculoskeletal Health (FORMI), Oslo University Hospital HF, Ulleval, Bygg 37b, P.O. Box 4956 Nydalen, 0424, Oslo, Norway.'}, {'ForeName': 'John Anker', 'Initials': 'JA', 'LastName': 'Zwart', 'Affiliation': 'Faculty of Medicine, University of Oslo, P.O. Box 1072 Blindern, 0316, Oslo, Norway.'}]",BMC musculoskeletal disorders,['10.1186/s12891-020-03720-5']
2021,33087110,Sustainable waiting time reductions after introducing the STAT model for access and triage: 12-month follow up of a stepped wedge cluster randomised controlled trial.,"BACKGROUND


Timely access is a challenge for providers of outpatient and community-based health services, as seen by the often lengthy waiting lists to manage demand. The Specific Timely Appointments for Triage (STAT) model, an alternative approach for managing access and triage, reduced waiting time by 34% in a stepped wedge cluster randomised controlled trial involving 8 services and more than 3000 participants. Follow up periods ranged from 3 to 10 months across the participating services in accordance with the stepped wedge design. This study aimed to determine whether outcomes were sustained for a full 12 months after implementation of the STAT model at each site.
METHODS


Routinely collected service data were obtained for a total of 12 months following implementation of the STAT model at each of the 8 services that participated in a stepped wedge cluster randomised controlled trial. The primary outcome was time to first appointment. Secondary outcomes included non-attendance rates, time to second appointment and service use over 12 weeks. Outcomes were compared to pre-intervention data from the original trial, modelled using generalised linear mixed effects models accounting for clustering of sites.
RESULTS


A 29% reduction in waiting time could be attributed to STAT over 12 months, compared to 34% in the original trial. A reduction in variability in waiting time was sustained. There were no significant changes in time to second appointment or in the number of missed appointments in the extended follow up period.
CONCLUSIONS


STAT is an effective strategy for reducing waiting time in community-based outpatient services. At 12 months, small reductions in the overall effect are apparent, but reductions in variability are sustained, suggesting that people who previously waited the longest benefit most from the STAT model.
TRIAL REGISTRATION


This is a 12-month follow up of a stepped wedge cluster randomised controlled trial that was registered with the Australia and New Zealand Clinical Trials Registry ( ACTRN12615001016527 ).",2020,"There were no significant changes in time to second appointment or in the number of missed appointments in the extended follow up period.
","['3000 participants', 'Routinely collected service data were obtained for a total of 12\u2009months following implementation of the STAT model at each of the 8 services that participated in a stepped wedge cluster randomised controlled trial']",[],"['waiting time', 'time to first appointment', 'time to second appointment or in the number of missed appointments', 'non-attendance rates, time to second appointment and service use over 12\u2009weeks']","[{'cui': 'C0470279', 'cui_str': '3000'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0040861', 'cui_str': 'Triage'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439639', 'cui_str': 'Wedge'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],"[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0439230', 'cui_str': 'week'}]",8.0,0.355581,"There were no significant changes in time to second appointment or in the number of missed appointments in the extended follow up period.
","[{'ForeName': 'Katherine E', 'Initials': 'KE', 'LastName': 'Harding', 'Affiliation': 'Allied Health Clinical Rsearch Office, Eastern Health, Level 2/5 Arnold Street, Box Hill, VIC, 3128, Australia. katherine.harding@easternhealth.org.au.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Snowdon', 'Affiliation': 'Allied Health Clinical Rsearch Office, Eastern Health, Level 2/5 Arnold Street, Box Hill, VIC, 3128, Australia.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Prendergast', 'Affiliation': 'La Trobe University, Kingsbury Drive, Bundoora, VIC, 3086, Australia.'}, {'ForeName': 'Annie K', 'Initials': 'AK', 'LastName': 'Lewis', 'Affiliation': 'Allied Health Clinical Rsearch Office, Eastern Health, Level 2/5 Arnold Street, Box Hill, VIC, 3128, Australia.'}, {'ForeName': 'Bridie', 'Initials': 'B', 'LastName': 'Kent', 'Affiliation': 'Drake Circus, Plymouth University, Plymouth, Devon, PL4 8AA, UK.'}, {'ForeName': 'Sandy F', 'Initials': 'SF', 'LastName': 'Leggat', 'Affiliation': 'La Trobe University, Kingsbury Drive, Bundoora, VIC, 3086, Australia.'}, {'ForeName': 'Nicholas F', 'Initials': 'NF', 'LastName': 'Taylor', 'Affiliation': 'Allied Health Clinical Rsearch Office, Eastern Health, Level 2/5 Arnold Street, Box Hill, VIC, 3128, Australia.'}]",BMC health services research,['10.1186/s12913-020-05824-z']
2022,33087111,"Melatonin to prevent delirium in patients with advanced cancer: a double blind, parallel, randomized, controlled, feasibility trial.","BACKGROUND


Delirium is highly problematic in palliative care (PC). Preliminary data indicate a potential role for melatonin to prevent delirium, but no randomized controlled trials (RCTs) are reported in PC.
METHODS


Patients aged ≥18 years, with advanced cancer, admitted to an inpatient Palliative Care Unit (PCU), having a Palliative Performance Scale rating ≥ 30%, and for whom consent was obtained, were included in the study. Patients with delirium on admission were excluded. The main study objectives were to assess the feasibility issues of conducting a double-blind RCT of exogenous melatonin to prevent delirium in PC: recruitment, retention, procedural acceptability, appropriateness of outcome measures, and preliminary efficacy and safety data. Study participants were randomized in a double-blind, parallel designed study to receive daily melatonin 3 mg or placebo orally at 21:00 over 28 days or less if incident delirium, death, discharge or withdrawal occurred earlier. Delirium was diagnosed using the Confusion Assessment Method. Efficacy endpoints in the melatonin and placebo groups were compared using time-to-event analysis: days from study entry to onset of incident delirium.
RESULTS


Over 16 months, 60/616 (9.7%; 95% CI: 7.5-12.4%) screened subjects were enrolled. The respective melatonin (n = 30) vs placebo (n = 30) outcomes were: incident delirium in 11/30 (36.7%; 95%CI: 19.9-56.1%) vs 10/30 (33%; 95% CI: 17.3-52.8%); early discharge (6 vs 5); withdrawal (6 vs 3); death (0 vs 1); and 7 (23%) vs 11 (37%) reached the 28-day end point. The 25th percentile time-to-event were 9 and 18 days (log rank, χ 2  = 0.62, p = 0.43) in melatonin and placebo groups, respectively. No serious trial medication-related adverse effects occurred and the core study procedures were acceptable. Compared to those who remained delirium-free during their study participation, those who developed delirium (n = 21) had poorer functional (p = 0.036) and cognitive performance (p = 0.013), and in particular, poorer attentional capacity (p = 0.003) at study entry.
CONCLUSIONS


A larger double-blind RCT is feasible, but both subject accrual and withdrawal rates signal a need for multisite collaboration. The apparent trend for shorter time to incident delirium in the melatonin group bodes for careful monitoring in a larger trial.
TRIAL REGISTRATION


Registered on July 21st 2014 with ClinicalTrials.gov : NCT02200172 .",2020,"Over 16 months, 60/616 (9.7%; 95% CI: 7.5-12.4%) screened subjects were enrolled.","['Patients with delirium on admission were excluded', 'Patients aged ≥18\u2009years, with advanced cancer, admitted to an inpatient Palliative Care Unit (PCU), having a Palliative Performance Scale rating\u2009≥\u200930%, and for whom consent was obtained, were included in the study', 'patients with advanced cancer']","['melatonin and placebo', 'respective melatonin', 'melatonin', 'exogenous melatonin', 'placebo', 'daily melatonin 3\u2009mg or placebo', 'Melatonin']","['poorer functional', 'cognitive performance', 'poorer attentional capacity', 'Delirium', 'incident delirium', 'adverse effects', 'early discharge', '25th percentile time-to-event']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0457453', 'cui_str': 'On admission'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C4720846', 'cui_str': 'Palliative performance scale'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1124060', 'cui_str': 'Melatonin 3 MG'}]","[{'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",,0.819707,"Over 16 months, 60/616 (9.7%; 95% CI: 7.5-12.4%) screened subjects were enrolled.","[{'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Lawlor', 'Affiliation': 'Division of Palliative Care, Department of Medicine, University of Ottawa, 43 Bruyère Street, Ottawa, ON, K1N 5C8, Canada. plawlor@bruyere.org.'}, {'ForeName': 'Marie T', 'Initials': 'MT', 'LastName': 'McNamara-Kilian', 'Affiliation': 'Bruyère Research Institute, Ottawa, Canada.'}, {'ForeName': 'Alistair R', 'Initials': 'AR', 'LastName': 'MacDonald', 'Affiliation': 'Bruyère Research Institute, Ottawa, Canada.'}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Momoli', 'Affiliation': 'School of Epidemiology and Public Health, University of Ottawa, London, Canada.'}, {'ForeName': 'Sallyanne', 'Initials': 'S', 'LastName': 'Tierney', 'Affiliation': 'Bruyère Continuing Care, Ottawa, Canada.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Lacaze-Masmonteil', 'Affiliation': 'Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'Monidipa', 'Initials': 'M', 'LastName': 'Dasgupta', 'Affiliation': 'Department of Geriatric Medicine, Department of Medicine, University of Western Ontario, London, Canada.'}, {'ForeName': 'Meera', 'Initials': 'M', 'LastName': 'Agar', 'Affiliation': 'Centre of Cardiovascular and Chronic Care, Faculty of Health, University of Technology Sydney, Hamilton, Canada.'}, {'ForeName': 'Jose L', 'Initials': 'JL', 'LastName': 'Pereira', 'Affiliation': 'Division of Palliative Care, Department of Family Medicine, McMaster University, Hamilton, Canada.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Currow', 'Affiliation': 'Centre of Cardiovascular and Chronic Care, Faculty of Health, University of Technology Sydney, Hamilton, Canada.'}, {'ForeName': 'Shirley H', 'Initials': 'SH', 'LastName': 'Bush', 'Affiliation': 'Division of Palliative Care, Department of Medicine, University of Ottawa, 43 Bruyère Street, Ottawa, ON, K1N 5C8, Canada.'}]",BMC palliative care,['10.1186/s12904-020-00669-z']
2023,33087170,"Suicide Reduction in Schizophrenia via Exercise (SUnRISE): study protocol for a multi-site, single-blind, randomized clinical trial of aerobic exercise for suicide risk reduction in individuals with schizophrenia.","BACKGROUND


Suicide risk among individuals with schizophrenia (SZ) is intractably high, with over 40% of individuals attempting to take their own lives during their lifetime and an estimated 5-10% completing suicide. At present, available pharmacological and psychotherapeutic treatments offer limited risk reduction benefits, and thus, there remains an urgent need to explore novel interventions that will ameliorate this risk. Aerobic exercise (AE) has been shown to improve a number of predictors of suicide risk (e.g., depressed mood, sleeping difficulties). As individuals with SZ display a highly sedentary lifestyle, AE may reduce suicide risk.
METHODS


Employing a multi-site, single-blind, randomized clinical trial design, we will examine the impact of AE on risk for suicide and related variables in individuals with SZ. Participants will be randomized to one of two 12-week exercise interventions: AE or a stretching and toning (ST) control intervention. Primary outcome measures will include suicide risk (Columbia Suicide Severity Rating Scale, C-SSRS) and aerobic fitness (VO 2 max), along with additional measures of suicide risk, mood, emotion regulation, sleep, cognition, and physical activity, with assessments completed at baseline and after 6 and 12 weeks of interventions.
DISCUSSION


It is hypothesized that AE will reduce suicide risk among individuals with SZ. This study may offer support for a more efficacious treatment method for this population in addition to the pre-existing pharmacological and psychotherapeutic treatment regimens.
TRIAL REGISTRATION


Clinicaltrials.gov, NCT03270098 . Registered on September 1, 2017.",2020,"Primary outcome measures will include suicide risk (Columbia Suicide Severity Rating Scale, C-SSRS) and aerobic fitness (VO 2 max), along with additional measures of suicide risk, mood, emotion regulation, sleep, cognition, and physical activity, with assessments completed at baseline and after 6 and 12 weeks of interventions.
","['Suicide Reduction in Schizophrenia via Exercise (SUnRISE', 'individuals with schizophrenia (SZ', 'individuals with schizophrenia', 'individuals with SZ']","['Aerobic exercise (AE', 'aerobic exercise', 'AE', 'exercise interventions: AE or a stretching and toning (ST) control intervention']","['suicide risk reduction', 'suicide risk', 'suicide risk (Columbia Suicide Severity Rating Scale, C-SSRS) and aerobic fitness (VO 2 max), along with additional measures of suicide risk, mood, emotion regulation, sleep, cognition, and physical activity']","[{'cui': 'C0038661', 'cui_str': 'Suicide'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0563664', 'cui_str': 'At risk for suicide'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C3888485', 'cui_str': 'Columbia suicide severity rating scale'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",,0.115175,"Primary outcome measures will include suicide risk (Columbia Suicide Severity Rating Scale, C-SSRS) and aerobic fitness (VO 2 max), along with additional measures of suicide risk, mood, emotion regulation, sleep, cognition, and physical activity, with assessments completed at baseline and after 6 and 12 weeks of interventions.
","[{'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Beck-Felts', 'Affiliation': 'Department of Psychiatry, Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Place, Box 1230, New York, NY, 10029, USA.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Goodman', 'Affiliation': 'MIRECC, James J. Peters VA Medical Center, Bronx, NY, USA.'}, {'ForeName': 'Luz H', 'Initials': 'LH', 'LastName': 'Ospina', 'Affiliation': 'Department of Psychiatry, Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Place, Box 1230, New York, NY, 10029, USA.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Wall', 'Affiliation': 'Department of Psychiatry, Columbia University, New York, NY, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'McEvoy', 'Affiliation': 'Department of Psychiatry and Health Behavior, Georgia Regents University, Augusta, GA, USA.'}, {'ForeName': 'Lars F', 'Initials': 'LF', 'LastName': 'Jarskog', 'Affiliation': 'Department of Psychiatry, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Jacob S', 'Initials': 'JS', 'LastName': 'Ballon', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Palo Alto, CA, USA.'}, {'ForeName': 'Matthew N', 'Initials': 'MN', 'LastName': 'Bartels', 'Affiliation': 'Department of Rehabilitation Medicine, Albert Einstein College of Medicine/Montefiore Medical Center, Bronx, NY, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Buchsbaum', 'Affiliation': 'Department of Psychiatry, Columbia University, New York, NY, USA.'}, {'ForeName': 'Richard P', 'Initials': 'RP', 'LastName': 'Sloan', 'Affiliation': 'Department of Psychiatry, Columbia University, New York, NY, USA.'}, {'ForeName': 'T Scott', 'Initials': 'TS', 'LastName': 'Stroup', 'Affiliation': 'Department of Psychiatry, Columbia University, New York, NY, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kimhy', 'Affiliation': 'Department of Psychiatry, Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Place, Box 1230, New York, NY, 10029, USA. david.kimhy@mssm.edu.'}]",Trials,['10.1186/s13063-020-04788-z']
2024,33087178,Efficacy of an online cognitive behavioral therapy program developed for healthcare workers during the COVID-19 pandemic: the REduction of STress (REST) study protocol for a randomized controlled trial.,"BACKGROUND


The acknowledgment of the mental health toll of the COVID-19 epidemic in healthcare workers has increased considerably as the disease evolved into a pandemic status. Indeed, high prevalence rates of depression, sleep disorders, and post-traumatic stress disorder (PTSD) have been reported in Chinese healthcare workers during the epidemic peak. Symptoms of psychological distress are expected to be long-lasting and have a systemic impact on healthcare systems, warranting the need for evidence-based psychological treatments aiming at relieving immediate stress and preventing the onset of psychological disorders in this population. In the current COVID-19 context, internet-based interventions have the potential to circumvent the pitfalls of face-to-face formats and provide the flexibility required to facilitate accessibility to healthcare workers. Online cognitive behavioral therapy (CBT) in particular has proved to be effective in treating and preventing a number of stress-related disorders in populations other than healthcare workers. The aim of our randomized controlled trial study protocol is to evaluate the efficacy of the 'My Health too' CBT program-a program we have developed for healthcare workers facing the pandemic-on immediate perceived stress and on the emergence of psychiatric disorders at 3- and 6-month follow-up compared to an active control group (i.e., bibliotherapy).
METHODS


Powered for superiority testing, this six-site open trial involves the random assignment of 120 healthcare workers with stress levels > 16 on the Perceived Stress Scale (PSS-10) to either the 7-session online CBT program or bibliotherapy. The primary outcome is the decrease of PSS-10 scores at 8 weeks. Secondary outcomes include depression, insomnia, and PTSD symptoms; self-reported resilience and rumination; and credibility and satisfaction. Assessments are scheduled at pretreatment, mid-treatment (at 4 weeks), end of active treatment (at 8 weeks), and at 3-month and 6-month follow-up.
DISCUSSION


This is the first study assessing the efficacy and the acceptability of a brief online CBT program specifically developed for healthcare workers. Given the potential short- and long-term consequences of the COVID-19 pandemic on healthcare workers' mental health, but also on healthcare systems, our findings can significantly impact clinical practice and management of the ongoing, and probably long-lasting, health crisis.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04362358 , registered on April 24, 2020.",2020,"Given the potential short- and long-term consequences of the COVID-19 pandemic on healthcare workers' mental health, but also on healthcare systems, our findings can significantly impact clinical practice and management of the ongoing, and probably long-lasting, health crisis.
","['healthcare workers during the COVID-19 pandemic', 'healthcare workers', '120 healthcare workers with stress levels >\u200916 on the Perceived Stress Scale (PSS-10) to either the']","['Online cognitive behavioral therapy (CBT', 'online CBT program', '7-session online CBT program or bibliotherapy', 'online cognitive behavioral therapy program']","['depression, insomnia, and PTSD symptoms; self-reported resilience and rumination; and credibility and satisfaction', 'decrease of PSS-10 scores']","[{'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1615608', 'cui_str': 'Pandemics'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}, {'cui': 'C0582653', 'cui_str': 'Perceived stress scale'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0005365', 'cui_str': 'Bibliotherapy'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0154575', 'cui_str': 'Rumination disorder'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0582653', 'cui_str': 'Perceived stress scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0580722,"Given the potential short- and long-term consequences of the COVID-19 pandemic on healthcare workers' mental health, but also on healthcare systems, our findings can significantly impact clinical practice and management of the ongoing, and probably long-lasting, health crisis.
","[{'ForeName': 'Luisa', 'Initials': 'L', 'LastName': 'Weiner', 'Affiliation': ""Pôle de Psychiatrie, Santé Mentale et Addictologie, Hôpitaux Universitaires de Strasbourg, 1 place de l'hôpital, 67000, Strasbourg, France. weiner.l@gmail.com.""}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Berna', 'Affiliation': ""Pôle de Psychiatrie, Santé Mentale et Addictologie, Hôpitaux Universitaires de Strasbourg, 1 place de l'hôpital, 67000, Strasbourg, France.""}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Nourry', 'Affiliation': 'Faculté de Médecine, Université de Strasbourg, Strasbourg, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Severac', 'Affiliation': 'Département de Santé Publique, GMRC, Hôpitaux Universitaires de Strasbourg, Strasbourg, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Vidailhet', 'Affiliation': ""Pôle de Psychiatrie, Santé Mentale et Addictologie, Hôpitaux Universitaires de Strasbourg, 1 place de l'hôpital, 67000, Strasbourg, France.""}, {'ForeName': 'Amaury C', 'Initials': 'AC', 'LastName': 'Mengin', 'Affiliation': ""Pôle de Psychiatrie, Santé Mentale et Addictologie, Hôpitaux Universitaires de Strasbourg, 1 place de l'hôpital, 67000, Strasbourg, France.""}]",Trials,['10.1186/s13063-020-04772-7']
2025,33087220,Clinical and Radiographic Success of Low-Level Laser Therapy Compared with Formocresol Pulpotomy Treatment in Primary Molars.,"Purpose:  The purpose of this study was to assess and compare the clinical and radiographic success rates of low-level laser therapy (LLLT) and formocresol (FC) for pulpotomy in primary teeth.  Methods:  Utilizing a split-mouth technique, 106 primary molars of 36 five- to eight-year-olds were included. The teeth were selected according to specific clinical and radiographic inclusion criteria and randomly assigned to the LLLT group and FC group. A pulpotomy was performed on each molar; 53 teeth were treated with LLLT, and 53 teeth were treated using FC. Children were followed at six and 12 months for clinical and radiographic evaluation.  Results:  At six months, the clinical success rate was 98 percent for each group. Radiographic success was 100 percent for the LLLT group and 98 percent for the FC group. At 12 months, both groups showed a clinical success of 96.1 percent. Radiographic success at 12 months was 100 percent and 98 percent for LLLT and FC, respectively.  Conclusions:  Both low-level laser therapy and formocresol pulpotomy techniques showed favorable clinical and radiographic outcomes in human primary molar teeth over 12 months. Further longitudinal studies with longer follow-up periods and larger sample sizes are encouraged.",2020,Radiographic success was 100 percent for the LLLT group and 98 percent for the FC group.,"['106 primary molars of 36 five- to eight-year-olds were included', 'pulpotomy in primary teeth', 'Primary Molars']","['low-level laser therapy and formocresol pulpotomy techniques', 'low-level laser therapy (LLLT) and formocresol (FC', 'Low-Level Laser Therapy', 'LLLT', 'Formocresol Pulpotomy', 'FC']","['clinical success', 'Radiographic success', 'clinical success rate']","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0034104', 'cui_str': 'Pulpotomy'}, {'cui': 'C3266841', 'cui_str': 'All deciduous teeth'}]","[{'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}, {'cui': 'C0016583', 'cui_str': 'Formocresols'}, {'cui': 'C0034104', 'cui_str': 'Pulpotomy'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}]",53.0,0.0440837,Radiographic success was 100 percent for the LLLT group and 98 percent for the FC group.,"[{'ForeName': 'Najlaa', 'Initials': 'N', 'LastName': 'Alamoudi', 'Affiliation': 'Dr. Alamoudi is a professor, Department of Pediatric Dentistry, Faculty of Dentistry, King Abdulaziz University, Jeddah, Saudi Arabia;, Email: nalamoudi@kau.edu.sa.'}, {'ForeName': 'Alaa', 'Initials': 'A', 'LastName': 'Nadhreen', 'Affiliation': 'Dr. Nadhreen is a teacher assistant, Department of Pediatric Dentistry, Faculty of Dentistry, King Abdulaziz University, Jeddah, Saudi Arabia.'}, {'ForeName': 'Heba', 'Initials': 'H', 'LastName': 'Sabbagh', 'Affiliation': 'Dr. Sabbagh is an assistant professor, Department of Pediatric Dentistry, Faculty of Dentistry, King Abdulaziz University, Jeddah, Saudi Arabia.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'El Meligy', 'Affiliation': 'Dr. El Meligy is a professor, Department of Pediatric Dentistry, Faculty of Dentistry, King Abdulaziz University, Jeddah, Saudi Arabia; and a professor in the Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Alexandria University, Alexandria, Egypt.'}, {'ForeName': 'Amani', 'Initials': 'A', 'LastName': 'Al Tuwirqi', 'Affiliation': 'Dr. Al Tuwirqi is an associate professor, Department of Pediatric Dentistry, Faculty of Dentistry, King Abdulaziz University, Jeddah, Saudi Arabia.'}, {'ForeName': 'Heba', 'Initials': 'H', 'LastName': 'Elkhodary', 'Affiliation': 'Dr. Elkhodary is an associate professor, Pediatric Dentistry Department, Faculty of Dentistry, King Abdulaziz University, Jeddah, Saudi Arabia; and an assistant professor in the Pediatric Dentistry and Dental Public Health Department, Faculty of Dental Medicine for Girls, AlAzhar University, Cairo, Egypt.'}]",Pediatric dentistry,[]
2026,33087221,Clinical Comparison of Three Esthetic Full-Coverage Restorations in Primary Maxillary Incisors at 12 Months.,"Purpose:  The purpose of this study was to compare the 12-month clinical outcomes of primary maxillary incisors restored with composite strip crowns (CSCs), NuSmile preveneered stainless steel crowns (PVSSCs), and NuSmile zirconia crowns (ZCs).  Methods:  A total of 135 teeth in 49 two- to four-year-olds with early childhood caries were randomly assigned to crown groups. Demographic and tooth-related variables at baseline and 12 months were assessed by calibrated examiners. Fisher's exact or chi-square tests were used to test associations (P<0.05). Parental satisfaction of crown esthetics was evaluated by questionnaire.  Results:  Children were, on average, 3.4 years old, female (55 percent), and had a mean decayed, missing, and filled primary teeth (dmft) index score of 10.6. At 12 months, crown retention was significantly lower for CSCs versus PVSSCs or ZCs (79 percent, 100 percent, and 95 percent, respectively; P=0.002). Partial and complete loss of material was significantly higher in CSCs than PVSSCs or ZCs (29 percent, 11 percent, and zero percent, respectively; P<0.001). CSCs presented with increased marginal discrepancies and color change (P<0.001). Most parents were very satisfied (87 percent); those dissatisfied were concerned with the color of CSCs and PVSSCs (63 percent versus 37 percent; P=0.005).  Conclusions:  Composite strip crowns showed significantly reduced clinical success in retention, durability, marginal adaptation, and color compared to preveneered stainless steel crowns or zirconia crowns. Parental esthetic satisfaction was highest for NuSmile ZCs.",2020,CSCs presented with increased marginal discrepancies and color change (P<0.001).,"['A total of 135 teeth in 49 two- to four-year-olds with early childhood caries', 'Children were, on average, 3.4 years old, female (55 percent), and had a mean decayed, missing, and filled primary teeth (dmft) index score of 10.6', 'Primary Maxillary Incisors at 12 Months']","['composite strip crowns (CSCs', 'Esthetic Full-Coverage Restorations', 'Composite strip crowns']","['Parental esthetic satisfaction', 'Parental satisfaction of crown esthetics', 'Partial and complete loss of material', 'marginal discrepancies and color change', 'clinical success in retention, durability, marginal adaptation, and color', 'crown retention']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C3714731', 'cui_str': 'Early childhood caries'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4517692', 'cui_str': '3.4'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C3266841', 'cui_str': 'All deciduous teeth'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0021156', 'cui_str': 'Structure of incisor tooth'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0185047', 'cui_str': 'Stripping'}, {'cui': 'C0010384', 'cui_str': 'Crown'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0010384', 'cui_str': 'Crown'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C1290905', 'cui_str': 'Discrepancy'}, {'cui': 'C0475330', 'cui_str': 'Color change'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0009393', 'cui_str': 'Color'}]",135.0,0.175825,CSCs presented with increased marginal discrepancies and color change (P<0.001).,"[{'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Gill', 'Affiliation': 'Dr. Gill is a pediatric dentist in private practice, Toronto, Ontario, Canada;, Email: ashley.gill.ubc@gmail.com.'}, {'ForeName': 'Mariella', 'Initials': 'M', 'LastName': 'Garcia', 'Affiliation': 'Dr. Garcia is a clinical assistant professor, Department of Pediatric Dentistry, School of Dentistry, University of Washington, Seattle, Wash., USA.'}, {'ForeName': 'Se', 'Initials': 'S', 'LastName': 'Won An', 'Affiliation': 'Dr. An is a dentist in private practice, Seattle, Wash., USA.'}, {'ForeName': 'JoAnna', 'Initials': 'J', 'LastName': 'Scott', 'Affiliation': 'Dr. Scott is an assistant professor, Research and Graduate Program, School of Dentistry, at the University of Missouri-Kansas City, Kansas City, Mo., USA.'}, {'ForeName': 'Ana Lucia', 'Initials': 'AL', 'LastName': 'Seminario', 'Affiliation': 'Dr. Seminario is an associate professor, Department of Pediatric Dentistry, School of Dentistry, an adjunct associate professor, Department of Global Health, School of Public Health, and director of the UW Timothy A. DeRouen Center for Global Oral Health; University of Washington, Seattle, Wash., USA.'}]",Pediatric dentistry,[]
2027,33092327,"Eight-week equipment based Pilates exercises positively affects quality of life, and functional capacity in non-active adult women: a randomized controlled trial.","BACKGROUND


The Pilates exercises are popular for muscle conditioning among women. However, the effects on conditioning of healthy non-active adult women due to Pilates practicing are not fully explained.
OBJECTIVE


The purpose of this randomized controlled trial was to assess the effects of equipment based Pilates exercises on the percentage of body fat, weight, body mass index (BMI), functional capacity, and quality of life of adult healthy women.
METHODS


Seventy-eight non-active women were randomly assigned to 2 groups (Pilates or Control). The Pilates group performed a total of 16 exercise sessions (60 minutes each, performed twice a week for 8 consecutive weeks). The control group was instructed to perform no exercise. Percentage of body fat (DXA scans), weight, BMI, distance covered in the incremental shuttle walk test, maximal oxygen uptake (VO2max), and quality of life (SF-36 scores) were analyzed.
RESULTS


There were no significant between-group differences at baseline, but significant group-by-time interaction was observed for Pilates group post-intervention. Higher distance covered (p=0.01), VO2max (p=0.04), and quality of life (p=0.04) were observed after the intervention compared to the control group. No differences were observed for body composition.
CONCLUSIONS


Two months of equipment based Pilates training improved functional capacity and quality of life in healthy adult women.",2020,"Higher distance covered (p=0.01), VO2max (p=0.04), and quality of life (p=0.04) were observed after the intervention compared to the control group.","['non-active adult women', 'women', 'adult healthy women', 'Seventy-eight non-active women', 'healthy adult women']","['16 exercise sessions', 'equipment based Pilates exercises', 'equipment based Pilates training']","['quality of life, and functional capacity', 'functional capacity and quality of life', 'percentage of body fat, weight, body mass index (BMI), functional capacity, and quality of life', 'quality of life', 'body composition', 'Percentage of body fat (DXA scans), weight, BMI, distance covered in the incremental shuttle walk test, maximal oxygen uptake (VO2max), and quality of life (SF-36 scores']","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C3816957', 'cui_str': '70'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0014672', 'cui_str': 'Equipment'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1321049', 'cui_str': 'Pilates exercise'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C4280053', 'cui_str': 'Incremental Shuttle Walk Test'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",78.0,0.074949,"Higher distance covered (p=0.01), VO2max (p=0.04), and quality of life (p=0.04) were observed after the intervention compared to the control group.","[{'ForeName': 'Fábio M', 'Initials': 'FM', 'LastName': 'Martins', 'Affiliation': 'Department of Physical Therapy, Federal University of Jequitinhonha and Mucuri Valleys, Diamantina, Brazil.'}, {'ForeName': 'Ester G', 'Initials': 'EG', 'LastName': 'da Silva', 'Affiliation': 'Department of Physical Therapy, Federal University of Jequitinhonha and Mucuri Valleys, Diamantina, Brazil.'}, {'ForeName': 'Matheus A', 'Initials': 'MA', 'LastName': 'Souza', 'Affiliation': 'Department of Physical Therapy, Federal University of Juiz de Fora, Governador Valadares, Brazil.'}, {'ForeName': 'Edgar R', 'Initials': 'ER', 'LastName': 'Vieira', 'Affiliation': 'Department of Physical Therapy, Florida International University, Miami, FL, USA.'}, {'ForeName': 'Rubens A', 'Initials': 'RA', 'LastName': 'da Silva', 'Affiliation': 'Department of Health Sciences, Physical Therapy Program McGill-UQAC, Laboratory of research LabBioNR, Université du Québec à Chicoutimi (UQAC), Saguenay, QC, Canada.'}, {'ForeName': 'Alexandre W', 'Initials': 'AW', 'LastName': 'Barbosa', 'Affiliation': 'Department of Physical Therapy, Federal University of Juiz de Fora, Governador Valadares, Brazil - alexwbarbosa@hotmail.com.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.20.11327-6']
2028,33087990,THE SHORT-TERM IMPACT OF UNCONDITIONAL CASH TRANSFERS TO THE POOR: EXPERIMENTAL EVIDENCE FROM KENYA.,"We use a randomized controlled trial to study the response of poor households in rural Kenya to unconditional cash transfers from the NGO GiveDirectly. The transfers differ from other programs in that they are explicitly unconditional, large, and concentrated in time. We randomized at both the village and household levels; furthermore, within the treatment group, we randomized recipient gender (wife versus husband), transfer timing (lump-sum transfer versus monthly installments), and transfer magnitude (US$404 PPP versus US$1,525 PPP). We find a strong consumption response to transfers, with an increase in household monthly consumption from $158 PPP to $193 PPP nine months after the transfer began. Transfer recipients experience large increases in psychological well-being. We find no overall effect on levels of the stress hormone cortisol, although there are differences across some subgroups. Monthly transfers are more likely than lump-sum transfers to improve food security, whereas lump-sum transfers are more likely to be spent on durables, suggesting that households face savings and credit constraints. Together, these results suggest that unconditional cash transfers have significant impacts on economic outcomes and psychological well-being.",2016,"We find a strong consumption response to transfers, with an increase in household monthly consumption from $158 PPP to $193 PPP nine months after the transfer began.",['poor households in rural Kenya to unconditional cash transfers from the NGO GiveDirectly'],"['transfer timing (lump-sum transfer versus monthly installments), and transfer magnitude (US$404 PPP versus US$1,525 PPP']",[],"[{'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}]","[{'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0449243', 'cui_str': 'Timing'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0449286', 'cui_str': 'Degree'}, {'cui': 'C0031106', 'cui_str': 'Aggressive periodontitis'}]",[],,0.0373585,"We find a strong consumption response to transfers, with an increase in household monthly consumption from $158 PPP to $193 PPP nine months after the transfer began.","[{'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Haushofer', 'Affiliation': 'Princeton University and Busara Center for Behavioral Economics, Busara Center for Behavioral Economics.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Shapiro', 'Affiliation': 'Princeton University and Busara Center for Behavioral Economics, Busara Center for Behavioral Economics.'}]",The quarterly journal of economics,['10.1093/qje/qjw025']
2029,33088057,"Comparative evaluation of treatment of noncarious cervical hypersensitivity by a fluoride varnish, a dentin bonding agent, and Er, Cr:YSGG laser: An  in vivo  study.","Context


Dentin hypersensitivity is one of the most common dental problems encountered regularly. This commonly appearing condition is quite difficult to treat satisfactorily, and so, a large number of techniques and therapeutic alternatives constantly are being proposed to relieve it. However, till date, the search for an ideal agent is on. Various laser systems have been discussed as a new treatment option for dentin hypersensitivity. Researchers are claiming good prognosis with lasers. Treatment with soft tissue lasers is being practiced for some time and is well documented. However, the use of Er, Cr:YSGG laser for desensitization purpose is new, and the available data on clinical outcome are limited.
Aims


The purpose of this study was to test and compare the efficacy of a fluoride varnish, a dentin bonding agent, and Er, Cr: YSGG laser in treating noncarious cervical hypersensitivity,  in vivo .
Settings and Design


Fifty patients aged between 25 and 55 years complaining of dentinal hypersensitivity who reported to the Department of Conservative Dentistry and Endodontics, Dr. R. Ahmed Dental College and Hospital, Kolkata, participated in this study.
Subjects and Methods


Sensitive teeth in each patient were randomly divided into three treatment groups: Group 1 treated with fluoride varnishGroup 2 treated with dentin bonding agentGroup 3 treated with Er, Cr: YSGG laser. Hypersensitivity assessment was done pretreatment, immediately posttreatment, and 1 day, 1, 2, 3, and 4 weeks postoperatively.
Statistical Analysis Used


The data obtained were tabulated and subjected to statistical analysis using the paired and unpaired  t -test.
Results


In all the treatment groups, there was significant decrease in mean hypersensitivity scores from pretreatment values after 4 weeks. The posttreatment hypersensitivity scores of Group 3 were minimum for all three test stimuli followed by Group 2 and Group 1, respectively.
Conclusions


All the three treatment agents, namely fluoride varnish, dentin bonding agent, and Er, Cr:YSGG laser, were effective in treating dentin hypersensitivity. Least recurrence in hypersensitivity occurred in the laser-treated group. Even where recurrences did occur, hypersensitivity did not return to pretreatment value and occurred more in those cases exhibiting high pretreatment sensitivity.",2019,"The posttreatment hypersensitivity scores of Group 3 were minimum for all three test stimuli followed by Group 2 and Group 1, respectively.
","['Fifty patients aged between 25 and 55 years complaining of dentinal hypersensitivity who reported to the Department of Conservative Dentistry and Endodontics, Dr. R. Ahmed Dental College and Hospital, Kolkata, participated in this study', 'Subjects and Methods\n\n\nSensitive teeth in each patient']","['fluoride varnish, a dentin bonding agent, and Er, Cr:YSGG laser', 'fluoride varnish, dentin bonding agent, and Er, Cr:YSGG laser', 'soft tissue lasers', 'fluoride varnish, a dentin bonding agent, and Er, Cr: YSGG laser', 'fluoride varnishGroup 2 treated with dentin bonding agentGroup 3 treated with Er, Cr: YSGG laser']","['mean hypersensitivity scores', 'Hypersensitivity assessment', 'Least recurrence in hypersensitivity', 'posttreatment hypersensitivity scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0011438', 'cui_str': 'Dentistry'}, {'cui': 'C0332274', 'cui_str': 'Endodontic'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}]","[{'cui': 'C0016326', 'cui_str': 'Fluoride Varnishes'}, {'cui': 'C0162652', 'cui_str': 'Dentine bonding agent'}, {'cui': 'C0879167', 'cui_str': 'Yttrium-Scandium-Gallium Garnet Lasers'}, {'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]",50.0,0.0220692,"The posttreatment hypersensitivity scores of Group 3 were minimum for all three test stimuli followed by Group 2 and Group 1, respectively.
","[{'ForeName': 'Amrita', 'Initials': 'A', 'LastName': 'Ghosh', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Dr. R. Ahmed Dental College and Hospital, Kolkata, West Bengal, India.'}, {'ForeName': 'Dibyendu', 'Initials': 'D', 'LastName': 'Mazumder', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Dr. R. Ahmed Dental College and Hospital, Kolkata, West Bengal, India.'}]",Journal of conservative dentistry : JCD,['10.4103/JCD.JCD_215_20']
2030,33088058,Effect of two desensitizing agents on dentin hypersensitivity: A randomized split-mouth clinical trial.,"Background


Clinical research is important to evaluate the effect of desensitizing agents.
Aims


This randomized clinical trial evaluated the immediate and 1 week desensitizing effect of two desensitizing agents Uno Topical Gel and Profluorid.
Materials and Methods


Thirtyfive patients with teeth presenting with dentin hypersensitivity were included in this clinical trial. Each quadrant in a patient was randomly assigned to one of two groups: Uno Topical Gel or Profluorid Varnish. A VAS score was used to assess tooth sensitivity at baseline, immediately after application of desensitizer and after 1 week. Additionally, 30 dentin discs were prepared, divided into Group 1(Control Group), Group 2 (Profluorid Varnish) and Group 3 (Uno Topical Gel) and examined using scanning electron microscopy (SEM) after 1hour and 24 hours to evaluate tubule occlusion.
Statistical Analysis


Clinical data were analysed using Friedman's test and Mann - Whitney U test. SEM data was analysed using Student's 2-sample  t -test.
Results


Uno group was significantly better to evaporative stimuli immediately ( P =0.01) after application. After 1 week, Uno group was significantly better to tactile ( P =0.000) and evaporative ( P =0.000) stimuli than Profluorid. SEM images showed that 1 hour after application, Uno and Profluorid demonstrated more than 90% and 80% dentin tubule occlusion respectively. At 24 hours, Uno and Profluorid demonstrated more than 50% and 60% dentin tubule occlusion respectively.
Conclusions


Uno Topical Gel was significantly better than Profluorid in reducing pain of dentin hypersensitivity due to tactile and evaporative stimuli after 1 week.",2019,"After 1 week, Uno group was significantly better to tactile ( P =0.000) and evaporative ( P =0.000) stimuli than Profluorid.","['30 dentin discs', 'Thirtyfive patients with teeth presenting with dentin hypersensitivity']","['desensitizing agents Uno Topical Gel and Profluorid', 'Group 2 (Profluorid Varnish) and Group 3 (Uno Topical Gel) and examined using scanning electron microscopy (SEM', 'Uno Topical Gel or Profluorid Varnish']","['tooth sensitivity', 'pain of dentin hypersensitivity', 'dentin hypersensitivity', 'evaporative stimuli']","[{'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0457755', 'cui_str': 'Tooth presence - finding'}, {'cui': 'C0011432', 'cui_str': 'Sensitive dentin'}]","[{'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C1160728', 'cui_str': 'Cutaneous gel'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0042359', 'cui_str': 'Varnish'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C0026020', 'cui_str': 'Scanning Electron Microscopy'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0026019', 'cui_str': 'Electron microscopic study'}]","[{'cui': 'C0011432', 'cui_str': 'Sensitive dentin'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}]",,0.04464,"After 1 week, Uno group was significantly better to tactile ( P =0.000) and evaporative ( P =0.000) stimuli than Profluorid.","[{'ForeName': 'Angambakkam Rajasekaran', 'Initials': 'AR', 'LastName': 'PradeepKumar', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Thai Moogambigai Dental College and Hospital, Dr. MGR Educational and Research Institute (Deemed to be University), Toronto, Canada.'}, {'ForeName': 'Venkatnagaraj', 'Initials': 'V', 'LastName': 'Viswanath', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Thai Moogambigai Dental College and Hospital, Dr. MGR Educational and Research Institute (Deemed to be University), Toronto, Canada.'}, {'ForeName': 'Kamna', 'Initials': 'K', 'LastName': 'Singh', 'Affiliation': 'Dental Research Institute, Faculty of Dentistry, 124 Edward Street, Toronto, Canada.'}, {'ForeName': 'Kuzhanchinathan', 'Initials': 'K', 'LastName': 'Manigandan', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Faculty of Dental Sciences, Sri Ramachandra Institute of Higher Education and Research (Deemed to be University), Chennai, Tamilnadu, India.'}, {'ForeName': 'HaseenaBegum', 'Initials': 'H', 'LastName': 'Iqbal', 'Affiliation': 'Dental Clinic, Chennai, Tamilnadu, India.'}, {'ForeName': 'Anil', 'Initials': 'A', 'LastName': 'Kishen', 'Affiliation': 'Dental Research Institute, Faculty of Dentistry, 124 Edward Street, Toronto, Canada.'}]",Journal of conservative dentistry : JCD,['10.4103/JCD.JCD_22_20']
2031,33088060,Evaluation of alpha-adrenomimetic agents for gingival retraction: A randomized crossover clinical trial.,"Context


The displacement of the gingiva around the tooth allows proper access during preparation, precise impression taking, and cementation procedures that has a direct bearing on the health of the periodontium. Several methods and agents are used for this purpose.
Aims


The primary aim of the study was to clinically evaluate the efficacy of naphazoline as a gingival retraction agent. The secondary aim was to compare it with tetrahydrozoline and aluminum chloride.
Settings and Design


Fifteen patients participated in a randomized crossover clinical trial at the Army College of Dental Sciences, Secunderabad, Telangana, India.
Subjects and Methods


Preliminary maxillary impressions were made with irreversible hydrocolloid for all patients to fabricate custom trays. After that, baseline impressions and cast for control group measurements were prepared. Gingival displacement was carried out in the right maxillary central incisor for all, with retraction cord soaked in three agents, either, aluminum chloride, tetrahydrozoline, or naphazoline. These agents were used in all patients with a washout period of 14 days. Elastomeric monophase impressions and die stone casts were recorded for each group. The central incisors were sectioned, and gingival retraction was measured using a measuring stereomicroscope.
Statistical Analysis Used


The gingival displacement was statistically analyzed using one-way ANOVA and  post hoc  Bonferroni.
Results


Naphazoline had the highest retraction (138.160 μm) followed by tetrahydrozoline (136.039 μm) and aluminum chloride (130.759 μm).
Conclusions


Naphazoline, tetrahydrozoline, and aluminum chloride show a clinically and statistically significant amount of displacement when compared to control. Among the three agents, naphazoline showed maximum displacement and maybe a good alternative with fewer side effects.",2019,"Results


Naphazoline had the highest retraction (138.160 μm) followed by tetrahydrozoline (136.039 μm) and aluminum chloride (130.759 μm).
","['Fifteen patients participated in a randomized crossover clinical trial at the Army College of Dental Sciences, Secunderabad, Telangana, India', 'gingival retraction']","['irreversible hydrocolloid', 'naphazoline', 'tetrahydrozoline and aluminum chloride', 'tetrahydrozoline', 'alpha-adrenomimetic agents', 'aluminum chloride, tetrahydrozoline, or naphazoline', 'aluminum chloride']","['Elastomeric monophase impressions and die stone casts', 'gingival displacement', 'highest retraction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0332523', 'cui_str': 'Retraction'}]","[{'cui': 'C0020266', 'cui_str': 'Hydrocolloid'}, {'cui': 'C0027373', 'cui_str': 'Naphazoline'}, {'cui': 'C0076286', 'cui_str': 'tetrahydrozoline'}, {'cui': 'C0051512', 'cui_str': 'Aluminum chloride hexahydrate'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0001648', 'cui_str': 'Adrenergic receptor agonist'}, {'cui': 'C0450442', 'cui_str': 'Agent'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0179686', 'cui_str': 'Cast'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0332523', 'cui_str': 'Retraction'}]",15.0,0.032474,"Results


Naphazoline had the highest retraction (138.160 μm) followed by tetrahydrozoline (136.039 μm) and aluminum chloride (130.759 μm).
","[{'ForeName': 'Neha', 'Initials': 'N', 'LastName': 'Mehra', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Army College of Dental Sciences, Secunderabad, Telangana, India.'}, {'ForeName': 'Ajita', 'Initials': 'A', 'LastName': 'Rathi', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Army College of Dental Sciences, Secunderabad, Telangana, India.'}, {'ForeName': 'Roshni', 'Initials': 'R', 'LastName': 'Sharma', 'Affiliation': 'Private Practitioner, Vidyaranyapuram, Mysuru, Karnataka, India.'}, {'ForeName': 'Mamta', 'Initials': 'M', 'LastName': 'Kaushik', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Army College of Dental Sciences, Secunderabad, Telangana, India.'}, {'ForeName': 'Tanushree', 'Initials': 'T', 'LastName': 'Sood', 'Affiliation': ""Private Practitioner, Satwalekar's Multispeciality Dental Hospital, Hyderabad, Telangana, India.""}]",Journal of conservative dentistry : JCD,['10.4103/JCD.JCD_76_19']
2032,33088223,Cost-effectiveness analysis of Coblation versus mechanical shaver debridement in patients following knee chondroplasty.,"Background


To compare costs and outcomes following knee chondroplasty with Coblation versus mechanical shaver debridement (MSD) in patients with grade III articular cartilage lesions of the knee.
Methods


A decision-analytic model was developed to compare costs and outcomes of the two methods from a US payer perspective. We used published clinical data from a single-center randomized clinical trial (RCT) designed to compare outcomes between Coblation and MSD in patients with grade III articular cartilage lesions of the medial femoral condyle. Following primary knee chondroplasty, patients experienced either treatment success (no additional surgery required) or required a revision over the 4 year follow-up period. Costs associated with the initial chondroplasty, physical therapy sessions through the 6 week postoperative period, and revision rates at 4 years post-surgery were estimated using 2018 US Medicare Physician Fee Schedule. Sensitivity analyses including a 10 year time horizon and threshold analyses were performed to test the robustness of the model.
Results


The estimated total cost per patient was $4614 and $7886 for Coblation and MSD, respectively, resulting in cost-savings of $3272 in favor of Coblation, making it a dominant strategy because of lower costs and improved clinical outcomes. Threshold analysis showed that Coblation remained dominant even when revision rates were assumed to increase from the base case rate of 14-66%. Sensitivity analyses showed that cost-saving results were insensitive to variations in revision rates, number of physical therapy sessions and the time horizon used.
Conclusion


Coblation chondroplasty is a cost-saving procedure compared with MSD in the treatment of patients with grade III articular cartilage lesions of the knee.",2020,"Following primary knee chondroplasty, patients experienced either treatment success (no additional surgery required) or required a revision over the 4 year follow-up period.","['patients following knee chondroplasty', 'patients with grade III articular cartilage lesions of the medial femoral condyle', 'patients with grade III articular cartilage lesions of the knee']","['Coblation versus mechanical shaver debridement', 'Coblation and MSD', 'knee chondroplasty with Coblation versus mechanical shaver debridement (MSD', 'MSD']",['estimated total cost per patient'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0408200', 'cui_str': 'Chondroplasty'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0007303', 'cui_str': 'Structure of articular cartilage'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0448196', 'cui_str': 'Structure of medial condyle of femur'}]","[{'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0311227', 'cui_str': 'Aluminosis of lung'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0408200', 'cui_str': 'Chondroplasty'}]","[{'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",,0.0311742,"Following primary knee chondroplasty, patients experienced either treatment success (no additional surgery required) or required a revision over the 4 year follow-up period.","[{'ForeName': 'Ayoade', 'Initials': 'A', 'LastName': 'Adeyemi', 'Affiliation': 'Smith & Nephew, Inc, Andover, MA USA.'}, {'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'Nherera', 'Affiliation': 'Smith & Nephew, Inc, Hull, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Trueman', 'Affiliation': 'Smith & Nephew, Inc, Hull, UK.'}, {'ForeName': 'Anil', 'Initials': 'A', 'LastName': 'Ranawat', 'Affiliation': 'Department of Sports, Hospital for Special Surgery, New York, NY USA.'}]",Cost effectiveness and resource allocation : C/E,['10.1186/s12962-020-00240-w']
2033,33088296,Comparison of dialectical behavior therapy and anti-anxiety medication on anxiety and digestive symptoms in patients with functional dyspepsia.,"Background


Functional dyspepsia is a common chronic digestive disorder. The purpose of this study was to compare the effectiveness of dialectical behavior therapy and anti-anxiety medication in patients with functional dyspepsia.
Materials and Methods


The present study was a randomized, controlled clinical trial with sixty patients who were suffering from functional dyspepsia that identified by the ROME III criteria. Patients were divided into three groups by using pre- and posttest design, including Group A (dialectal treatment and pantoprazole), Group B (anxiolytic drug treatment and pantoprazole), and Group C (no intervention, only pantoprazole were used). The Beck Anxiety Inventory and the patient assessment of Gastrointestinal Symptom Severity Index Questionnaire were completed by the patients after receiving the written consent. Finally, the data were analyzed using the Statistical Package for the Social Sciences software version 20.
Results


There was a significant improvement in the severity of dyspepsia after intervention in all three groups. The greatest decrease in the severity of functional dyspepsia was observed in the dialectical behavioral therapy group as compared to the other groups (Group A: -15.4 ± 6.61, Group B: -3.85 ± 2.77, and Group C: -7.8 ± 4.02;  P  = 0.001). Furthermore, the Beck Anxiety Inventory scores were statistically significantly improved in all three groups (Group A: -5.75 ± 2.53, Group B: -7.3 ± 3.19, and Group C: -2.60 ± 1.5;  P  = 0.001). There was a positive correlation between the change in dyspepsia score and change in anxiety score across different intervention groups ( r  = 0.55;  P  < 0.001).
Conclusion


Dialectical behavioral therapy can be effective in reducing anxiety and improving the dyspepsia symptoms in patients with functional dyspepsia compared to anti-anxiety medication or conventional therapy. Therefore, communication between the physicians and psychologists and psychiatrists can have positive effects on the treatment of these patients.",2020,"Furthermore, the Beck Anxiety Inventory scores were statistically significantly improved in all three groups (Group A: -5.75 ± 2.53, Group B: -7.3 ± 3.19, and Group C: -2.60 ± 1.5;  P  = 0.001).","['patients with functional dyspepsia', 'sixty patients who were suffering from functional dyspepsia that identified by the ROME III criteria']","['dialectical behavior therapy and anti-anxiety medication', 'Dialectical behavioral therapy', 'Group A (dialectal treatment and pantoprazole), Group B (anxiolytic drug treatment and pantoprazole), and Group C (no intervention, only pantoprazole']","['severity of functional dyspepsia', 'Beck Anxiety Inventory scores', 'anxiety and digestive symptoms', 'dyspepsia score and change in anxiety score', 'severity of dyspepsia', 'dyspepsia symptoms', 'Beck Anxiety Inventory and the patient assessment of Gastrointestinal Symptom Severity Index Questionnaire']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0267167', 'cui_str': 'Nonulcer dyspepsia'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C1321145', 'cui_str': 'Dialectical behavior therapy'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0081876', 'cui_str': 'pantoprazole'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0040614', 'cui_str': 'Tranquilizer'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0267167', 'cui_str': 'Nonulcer dyspepsia'}, {'cui': 'C4274492', 'cui_str': 'Beck Anxiety Inventory score'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0476288', 'cui_str': 'Digestive symptom'}, {'cui': 'C0013395', 'cui_str': 'Indigestion'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0582613', 'cui_str': 'Beck anxiety inventory'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",60.0,0.0246106,"Furthermore, the Beck Anxiety Inventory scores were statistically significantly improved in all three groups (Group A: -5.75 ± 2.53, Group B: -7.3 ± 3.19, and Group C: -2.60 ± 1.5;  P  = 0.001).","[{'ForeName': 'Tahmine', 'Initials': 'T', 'LastName': 'Tavakoli', 'Affiliation': 'Department of Gastroenterology, Faculty of Medicine, Birjand University of Medical Sciences, Birjand, Iran.'}, {'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Hoseini', 'Affiliation': 'Department of Gastroenterology, Faculty of Medicine, Birjand University of Medical Sciences, Birjand, Iran.'}, {'ForeName': 'Toktam Sadat Jafar', 'Initials': 'TSJ', 'LastName': 'Tabatabaee', 'Affiliation': 'Birjand Science and Research Branch, Islamic Azad University, Birjand, Iran.'}, {'ForeName': 'Zeinab', 'Initials': 'Z', 'LastName': 'Rostami', 'Affiliation': 'Student Research Committee, Birjand University of Medical Sciences, Birjand, Iran.'}, {'ForeName': 'Homa', 'Initials': 'H', 'LastName': 'Mollaei', 'Affiliation': 'Department of Biology, Faculty of Sciences, University of Birjand, Birjand, Iran.'}, {'ForeName': 'Afsane', 'Initials': 'A', 'LastName': 'Bahrami', 'Affiliation': 'Cellular and Molecular Research Center, Birjand University of Medical Sciences, Birjand, Iran.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Ayati', 'Affiliation': 'Department of Gastroenterology, Faculty of Medicine, Birjand University of Medical Sciences, Birjand, Iran.'}, {'ForeName': 'Bita', 'Initials': 'B', 'LastName': 'Bijari', 'Affiliation': 'Department of Community Medicine, Cardiovascular Disease Research Center, Birjand University of Medical Sciences, Birjand, Iran.'}]",Journal of research in medical sciences : the official journal of Isfahan University of Medical Sciences,['10.4103/jrms.JRMS_673_19']
2034,33088309,"Comparison of the efficacy of sublingual, oral, and vaginal administration of misoprostol in the medical treatment of missed abortion during first trimester of pregnancy: A randomized clinical trial study.","Background


This study was aimed at comparing the efficacy of different routes of misoprostol administration, including sublingual, oral, and vaginal, on the induction of medical abortion in the first trimester of pregnancy.
Materials and Methods


This open-label, randomized clinical trial study was performed on 172 individuals in three parallel groups of vaginal, sublingual, and oral administration of misoprostol. The participants were randomized using permuted blocks of six. A dose of 600 μg of misoprostol every 6 h (maximum of 4 doses) was administrated to each group. Higham chart and demographic questionnaires were completed by the investigator. Data were analyzed using Stata software version 12.
Results


The mean age of the participants was 29.81 ± 6.7 years, and the mean gestational age was 8.45 ± 2.32 weeks. We found a significant difference regarding the abortion success rate and the time interval between the administration of the drug among three groups ( P  = 0.036 and < 0.001 in turn). There was no statistically significant difference between the three groups in terms of severity and duration of vaginal bleeding until day 7 after induction ( P  = 0.091 and 0.143, respectively). Furthermore, we found statistically significant differences in some drugs, which induced side effects namely vomiting and headache, between the three groups ( P  = 0.032 and 0.028 in turn).
Conclusion


The findings suggest that vaginal administration of misoprostol is more successful than the sublingual and oral route for complete abortion; vaginal administration of misoprostol is an appropriate alternative to curettage.",2020,"There was no statistically significant difference between the three groups in terms of severity and duration of vaginal bleeding until day 7 after induction ( P  = 0.091 and 0.143, respectively).","['missed abortion during first trimester of pregnancy', '172 individuals in three parallel groups of vaginal, sublingual, and oral administration of', 'The mean age of the participants was 29.81 ± 6.7 years, and the mean gestational age was 8.45 ± 2.32 weeks']","['misoprostol', 'sublingual, oral, and vaginal administration of misoprostol']","['severity and duration of vaginal bleeding', 'vomiting and headache', 'abortion success rate and the time interval']","[{'cui': 'C0000814', 'cui_str': 'Missed miscarriage'}, {'cui': 'C0032979', 'cui_str': 'First trimester pregnancy'}, {'cui': 'C4517601', 'cui_str': '172'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0001565', 'cui_str': 'Sublingual route'}, {'cui': 'C0001563', 'cui_str': 'Medication administration: oral'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0085174', 'cui_str': 'Misoprostol'}, {'cui': 'C0001565', 'cui_str': 'Sublingual route'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0001561', 'cui_str': 'Medication administration: vaginal'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C2979982', 'cui_str': 'Vaginal bleeding'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1272706', 'cui_str': 'Interval'}]",,0.0903802,"There was no statistically significant difference between the three groups in terms of severity and duration of vaginal bleeding until day 7 after induction ( P  = 0.091 and 0.143, respectively).","[{'ForeName': 'Behnaz', 'Initials': 'B', 'LastName': 'Souizi', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medicine, Sabzevar University of Medical Sciences, Sabzevar, Iran.'}, {'ForeName': 'Rahim', 'Initials': 'R', 'LastName': 'Akrami', 'Affiliation': 'Department of Community Medicine, School of Medicine, Dezful University of Medical Sciences, Dezful, Iran.'}, {'ForeName': 'Fateme', 'Initials': 'F', 'LastName': 'Borzoee', 'Affiliation': 'Department of Operating Room, School of Paramedics, Sabzevar University of Medical Sciences, Sabzevar, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Sahebkar', 'Affiliation': 'Department of Social Medicine, School of Medicine, Sabzevar University of Medical Sciences, Sabzevar, Iran.'}]",Journal of research in medical sciences : the official journal of Isfahan University of Medical Sciences,['10.4103/jrms.JRMS_393_19']
2035,33088318,Safety and efficacy of fentanyl versus pethidine in cataract surgery under propofol- based sedation: A double-blind randomized controlled clinical trial.,"Background


The study was aimed to evaluate the safety and efficacy of fentanyl and pethidine on the sedative quality of patients who underwent phacoemulsification cataract surgery with Propofol.
Materials and Methods


In this double-blind randomized controlled clinical trial, patients who were candidates for elective phacoemulsification surgery with topical anesthesia were enrolled. The selected patients were randomly allocated into the two groups for receiving sedation with Propofol-Pethidine (PP) or propofol-fentanyl (PF) combinations. Demographic characteristics, hemodynamic parameters before, during, and after the operation, sedation and pain scores, and patients' and surgeons' satisfaction scores were compared in the two studied groups.
Results


In this trial, 70 patients (35 patients in each group) have completed the study. Mean (standard deviation) operation time was 22.9 (6.8) and 25.46 (7.7) minutes in PF and PP groups ( P  = 0.118).Mean pain score in PF 0.46 (0.14) was significantly higher than PP groups 0.236 (0.06) ( P  = 0.011). The mean value of diastolic and systolic blood pressures, pulse rate, and mean arterial pressure dioxide were significantly decreased in both PF and PP groups ( P   Time  < 0.001), although there was no significant difference between groups.
Conclusion


Our findings indicated the equivalence effects on hemodynamic parameters for both pethidine and fentanyl in combination with propofol in which they could provide appropriate sedation and safe anesthesia with lower complications and acceptable patients' and surgeons' satisfaction.",2020,pain score in PF 0.46 (0.14) was significantly higher than PP groups 0.236,"['cataract surgery under propofol- based sedation', 'patients who underwent phacoemulsification cataract surgery with Propofol', '70 patients (35 patients in each group) have completed the study', 'patients who were candidates for elective phacoemulsification surgery with topical anesthesia were enrolled']","['fentanyl', 'sedation with Propofol-Pethidine (PP) or propofol-fentanyl (PF) combinations', 'propofol', 'fentanyl and pethidine', 'pethidine']","['sedative quality', 'Safety and efficacy', 'safety and efficacy', 'mean value of diastolic and systolic blood pressures, pulse rate, and mean arterial pressure dioxide', ""sedation and pain scores, and patients' and surgeons' satisfaction scores"", 'hemodynamic parameters', 'pain score', 'Mean (standard deviation) operation time']","[{'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0282545', 'cui_str': 'Phacoemulsification'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0472473', 'cui_str': 'Topical local anesthetic'}]","[{'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0025376', 'cui_str': 'Meperidine'}]","[{'cui': 'C0020592', 'cui_str': 'HYPNOTICS AND SEDATIVES'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0232117', 'cui_str': 'Pulse rate'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",70.0,0.10305,pain score in PF 0.46 (0.14) was significantly higher than PP groups 0.236,"[{'ForeName': 'Hamidreza', 'Initials': 'H', 'LastName': 'Shetabi', 'Affiliation': 'Department of Anesthesiology, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Seyed Jalal', 'Initials': 'SJ', 'LastName': 'Hashemi', 'Affiliation': 'Department of Anesthesiology, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Fariba', 'Initials': 'F', 'LastName': 'Haghi', 'Affiliation': 'Student Research Committee, Medical School, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Dariush', 'Initials': 'D', 'LastName': 'Moradi Farsani', 'Affiliation': 'Department of Anesthesiology, Isfahan University of Medical Sciences, Isfahan, Iran.'}]",Journal of research in medical sciences : the official journal of Isfahan University of Medical Sciences,['10.4103/jrms.JRMS_932_19']
2036,33088468,"Evaluation of the Effects of Acarbose on Weight and Metabolic, Inflammatory, and Cardiovascular Markers in Patients with Obesity and Overweight.","Background


Metabolic syndrome (MetS) refers to a cluster of risk factors for cardiovascular disease and type 2 diabetes. The aim of this study is to assess the effects of acarbose as an antihyperglycemic agent (drug) on late complications of MetS.
Methods


This double-blind randomized clinical trial was done on patients with MetS admitted to Isfahan Endocrine and Metabolism Research Center. They were assigned randomly to two groups: A who received acarbose ( n  = 32) and group B who received a placebo ( n  = 42) for 6 months. Cardiovascular indexes including flow-mediated dilation (FMD), intima-media thickness (IMT), epicardial fat thickness (EFT), and C-reactive protein (CRP) were measured at baseline and 6 months after the treatment and compared between the two groups.
Results


Post-intervention mean of weight (mean difference: -2.5 ± 0.89) and abdominal obesity (mean difference: -2.2 ± 0.64) in acarbose group were significantly decreased ( P  value < 0.001). High-density lipoprotein (HDL) level in acarbose group was significantly higher than control group (44.7 ± 7.6 vs 41.1 ± 6.4;  P  value = 0.043), while the other metabolic parameters were not significantly different between the two groups ( P  value > 0.05). In both groups, CRP and EFT decreased significantly after the intervention, and the levels of CRP, EFT, and IMT markers in the acarbose group were significantly lower than control group ( P  value < 0.05).
Conclusions


The administration of acarbose in patients with MetS can decrease weight and abdominal obesity as well as the reduction of inflammatory and cardiovascular markers, including CRP, EFT, and IMT and also increases HDL.",2020,"In both groups, CRP and EFT decreased significantly after the intervention, and the levels of CRP, EFT, and IMT markers in the acarbose group were significantly lower than control group ( P  value < 0.05).
","['patients with MetS admitted to Isfahan Endocrine and Metabolism Research Center', 'Patients with Obesity and Overweight', 'patients with MetS']","['Acarbose', 'placebo', 'acarbose']","['High-density lipoprotein (HDL) level', 'Weight and Metabolic, Inflammatory, and Cardiovascular Markers', 'Cardiovascular indexes including flow-mediated dilation (FMD), intima-media thickness (IMT), epicardial fat thickness (EFT), and C-reactive protein (CRP', 'levels of CRP, EFT, and IMT markers', 'abdominal obesity', 'CRP and EFT', 'weight and abdominal obesity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0014136', 'cui_str': 'Structure of endocrine system'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}]","[{'cui': 'C0050393', 'cui_str': 'Acarbose'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0162864', 'cui_str': 'Tunica intima'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0442016', 'cui_str': 'Epicardial'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0334121', 'cui_str': 'Inflammatory myofibroblastic tumor'}, {'cui': 'C0311277', 'cui_str': 'Abdominal Obesity'}]",,0.0680778,"In both groups, CRP and EFT decreased significantly after the intervention, and the levels of CRP, EFT, and IMT markers in the acarbose group were significantly lower than control group ( P  value < 0.05).
","[{'ForeName': 'Noushin', 'Initials': 'N', 'LastName': 'Khalili', 'Affiliation': 'Isfahan Endocrine and Metabolism Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Safavipour', 'Affiliation': 'Isfahan Endocrine and Metabolism Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}]",International journal of preventive medicine,['10.4103/ijpvm.IJPVM_229_19']
2037,33088573,"What is the optimal time-response window for the use of photobiomodulation therapy combined with static magnetic field (PBMT-sMF) for the improvement of exercise performance and recovery, and for how long the effects last? A randomized, triple-blinded, placebo-controlled trial.","Background


The optimal time-response window for photobiomodulation therapy (PBMT) using low-level laser therapy (LLLT) and/or light emitting diodes therapy (LEDT) combined with static magnetic fields (sMF) before physical activity still was not fully investigated. The aim of the present study was to investigate the better of four time-response windows for PBMT combined with sMF (PBMT-sMF) use before exercise in humans.
Methods


A prospectively registered, randomized, triple-blinded (volunteers, therapists and assessors) placebo-controlled trial was carried out. Sixty healthy untrained male subjects were randomly allocated to six experimental groups ( n  = 10 per group): PBMT-sMF 5 mins, PBMT-sMF 3 h, PBMT-sMF 6 h, PBMT-sMF 1-day, placebo, and control. The control group performed all procedures, however did not receive any kind of intervention. PBMT-sMF active or PBMT-sMF placebo was applied precisely in different time points after baseline MVC test to ensure that both MVC tests and eccentric exercise protocol would occur at the same hour of the day in all groups. Then, after five minutes, 3 h, 6 h or 1-day (24 h) of PBMT-sMF treatment (active or placebo) the eccentric exercise protocol was performed. The primary outcome was peak torque obtained from maximum voluntary contraction (MVC). The secondary outcomes were creatine kinase (CK), and delayed onset muscle soreness (DOMS). The primary and secondary outcomes were measured at baseline, immediately after, 1 h, 24 h and 48 h after the eccentric exercise protocol.
Results


Sixty patients were randomized and analyzed to each sequence. The outcomes in absolute values show that all active PBMT-sMF groups increased ( p  < 0.05) MVC from immediately after to 1 h after eccentric exercise, and decreased (p < 0.05) CK activity at all time points. However, PBMT-sMF 5 mins, 3 h and 6 h groups showed better results in MVC and CK analysis from 24 h to 48 h, and also to DOMS ( p  < 0.05) at all time points. Participants did not report any adverse events.
Conclusions


PBMT-sMF can be used from 5 min to 6 h before exercise, and the effects can last up to 54 h after treatment. However, the effects start to decrease when a 1-day (24 h) time-response window is used.
Trial registration


NCT03420391. Registered 05 February 2018.",2020,"The outcomes in absolute values show that all active PBMT-sMF groups increased ( p  < 0.05) MVC from immediately after to 1 h after eccentric exercise, and decreased (p < 0.05)","['Sixty healthy untrained male subjects', 'humans', 'Sixty patients']","['PBMT combined with sMF (PBMT-sMF', 'PBMT-sMF 5 mins, PBMT-sMF 3\u2009h, PBMT-sMF 6\u2009h, PBMT-sMF 1-day, placebo, and control', 'PBMT-sMF active or PBMT-sMF placebo', 'PBMT-sMF treatment (active or placebo', 'photobiomodulation therapy (PBMT) using low-level laser therapy (LLLT) and/or light emitting diodes therapy (LEDT) combined with static magnetic fields (sMF', 'placebo', 'photobiomodulation therapy combined with static magnetic field (PBMT-sMF']","['CK activity', 'peak torque obtained from maximum voluntary contraction (MVC', 'MVC and CK analysis', 'creatine kinase (CK), and delayed onset muscle soreness (DOMS']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C4019433', 'cui_str': 'Photobiomodulation Therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0563533', 'cui_str': 'Magnetic field'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0041119', 'cui_str': 'Tritium'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0013007', 'cui_str': 'Methyldimethoxyamphetamine'}]",60.0,0.271832,"The outcomes in absolute values show that all active PBMT-sMF groups increased ( p  < 0.05) MVC from immediately after to 1 h after eccentric exercise, and decreased (p < 0.05)","[{'ForeName': 'Ernesto Cesar Pinto', 'Initials': 'ECP', 'LastName': 'Leal-Junior', 'Affiliation': 'Laboratory of Phototherapy and Innovative Technologies in Health (LaPIT), Post-graduate Program in Rehabilitation Sciences, Nove de Julho University, Rua Vergueiro, 235/249, São Paulo, SP 01504-001 Brazil.'}, {'ForeName': 'Marcelo Ferreira Duarte', 'Initials': 'MFD', 'LastName': 'de Oliveira', 'Affiliation': 'Laboratory of Phototherapy and Innovative Technologies in Health (LaPIT), Post-graduate Program in Rehabilitation Sciences, Nove de Julho University, Rua Vergueiro, 235/249, São Paulo, SP 01504-001 Brazil.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Joensen', 'Affiliation': 'Physiotherapy Research Group, Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Martin Bjørn', 'Initials': 'MB', 'LastName': 'Stausholm', 'Affiliation': 'Physiotherapy Research Group, Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Jan Magnus', 'Initials': 'JM', 'LastName': 'Bjordal', 'Affiliation': 'Physiotherapy Research Group, Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Shaiane Silva', 'Initials': 'SS', 'LastName': 'Tomazoni', 'Affiliation': 'Physiotherapy Research Group, Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway.'}]","BMC sports science, medicine & rehabilitation",['10.1186/s13102-020-00214-8']
2038,33088583,Feasibility randomised controlled trial examining the effects of the Anti-Doping Values in Coach Education (ADVICE) mobile application on doping knowledge and attitudes towards doping among grassroots coaches.,"Objectives


Sports coaches are influential in whether athletes dope, but receive very little antidoping education, particularly within entry-level coaching qualifications. We tested the feasibility of an antidoping intervention, delivered via a mobile application, which was designed to increase coaches' knowledge of doping and to reduce favourable doping attitudes.
Methods


A two-arm randomised controlled trial, with grassroots coaches who coach young amateur athletes aged between 14 and 18 years of age, was conducted. The Anti-Doping Values in Coach Education (ADVICE) mobile application included modules on fair play, substances, nutritional supplements, rules and leadership. The primary outcome was the change in doping knowledge, 6 weeks after receiving the mobile application. The secondary outcome was changes in doping attitudes.
Results


Grassroots coaches (n=200; aged between 18 and 71 years, with between 1 and 42 years of coaching experience) from 29 different countries completed baseline assessments, and 85 completed follow-up assessments, and were included in mixed analysis of variance analyses. The intervention increased coaches' knowledge about doping and also reduced favourable doping attitudes in the experimental arm.
Conclusion


The ADVICE mobile application is a feasible method for delivering and increasing grassroots coaches' knowledge of banned substances and the potential side effects of doping. Mobile application-based resources could facilitate a much wider dissemination of antidoping education.",2020,The ADVICE mobile application is a feasible method for delivering and increasing grassroots coaches' knowledge of banned substances and the potential side effects of doping.,"['grassroots coaches', 'Results\n\n\nGrassroots coaches (n=200; aged between 18 and 71 years, with between 1 and 42 years of coaching experience) from 29 different countries completed baseline assessments, and 85 completed follow-up assessments', 'grassroots coaches who coach young amateur athletes aged between 14 and 18\xa0years of age, was conducted']",['Anti-Doping Values in Coach Education (ADVICE) mobile application'],"['change in doping knowledge', 'changes in doping attitudes']","[{'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0013039', 'cui_str': 'Doping in Sports'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0013039', 'cui_str': 'Doping in Sports'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]",,0.152171,The ADVICE mobile application is a feasible method for delivering and increasing grassroots coaches' knowledge of banned substances and the potential side effects of doping.,"[{'ForeName': 'Adam Robert', 'Initials': 'AR', 'LastName': 'Nicholls', 'Affiliation': 'Department of Sport, Health, and Exercise Science, University of Hull, Hull, UK.'}, {'ForeName': 'Lucas R W', 'Initials': 'LRW', 'LastName': 'Fairs', 'Affiliation': 'Department of Sport, Health, and Exercise Science, University of Hull, Hull, UK.'}, {'ForeName': 'Mar', 'Initials': 'M', 'LastName': 'Plata-Andrés', 'Affiliation': 'Agencia Española de Protección de la Salud en el Deporte, Madrid, Spain.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Bailey', 'Affiliation': 'RBES Ltd, Berlin, Germany.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Cope', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Madigan', 'Affiliation': 'School of Sport, York Saint John University, York, UK.'}, {'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Koenen', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Senate of Berlin, Berlin, UK.'}, {'ForeName': 'Iva', 'Initials': 'I', 'LastName': 'Glibo', 'Affiliation': 'Department of Sport and Health Sciences, Technical University of Munich, Munchen, Germany.'}, {'ForeName': 'Nikolaos C', 'Initials': 'NC', 'LastName': 'Theodorou', 'Affiliation': 'Athens, Greece.'}, {'ForeName': 'Jean-Francois', 'Initials': 'JF', 'LastName': 'Laurent', 'Affiliation': 'The Association for International Sport for All, Frankfurt, Germany.'}, {'ForeName': 'Gaetan', 'Initials': 'G', 'LastName': 'Garcia', 'Affiliation': 'The Association for International Sport for All, Frankfurt, Germany.'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Chanal', 'Affiliation': 'Agence Française de Lutte Contre le Dopage, Paris, France.'}]",BMJ open sport & exercise medicine,['10.1136/bmjsem-2020-000800']
2039,33088584,"Associations between fitness, physical activity and mental health in a community sample of young British adolescents: baseline data from the Fit to Study trial.","Objectives


To examine relationships between fitness, physical activity and psychosocial problems among English secondary school pupils and to explore how components of physically active lifestyles are associated with mental health and well-being.
Methods


A total of 7385 participants aged 11-13 took a fitness test and completed self-reported measures of physical activity, attitudes to activity, psychosocial problems and self-esteem during the Fit to Study trial. Multilevel regression, which modelled school-level cluster effects, estimated relationships between activity, fitness and psychosocial problems; canonical correlation analysis (CCA) explored modes of covariation between active lifestyle and mental health variables. Models were adjusted for covariates of sex, free school meal status, age, and time and location of assessments.
Results


Higher fitness was linked with fewer internalising problems (β=-0.23; 95% CI -0.26 to -0.21; p<0.001). More activity was also related to fewer internalising symptoms (β=-0.24; 95% CI -0.27 to -0.20; p<0.001); the relationship between activity and internalising problems was significantly stronger for boys than for girls. Fitness and activity were also favourably related to externalising symptoms, with smaller effect sizes. One significant CCA mode, with a canonical correlation of 0.52 (p=0.001), was characterised high cross-loadings for positive attitudes to activity (0.46) and habitual activity (0.42) among lifestyle variables; and for physical and global self-esteem (0.47 and 0.42) among mental health variables.
Conclusion


Model-based and data-driven analysis methods indicate fitness as well as physical activity are linked to adolescent mental health. If effect direction is established, fitness monitoring could complement physical activity measurement when tracking public health.",2020,More activity was also related to fewer internalising symptoms (β=-0.24; 95% CI -0.27 to -0.20; p<0.001); the relationship between activity and internalising problems was significantly stronger for boys than for girls.,"['English secondary school pupils', '7385 participants aged 11-13 took a fitness test and completed self-reported measures of', 'young British adolescents']",[],"['fitness, physical activity and mental health', 'internalising symptoms', 'habitual activity', 'physical and global self-esteem', 'physical activity, attitudes to activity, psychosocial problems and self-esteem', 'fitness, physical activity and psychosocial problems', 'Fitness and activity']","[{'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0036530', 'cui_str': 'Secondary school'}, {'cui': 'C0034121', 'cui_str': 'Pupil structure'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]",[],"[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0033213', 'cui_str': 'Problem'}]",7385.0,0.0255648,More activity was also related to fewer internalising symptoms (β=-0.24; 95% CI -0.27 to -0.20; p<0.001); the relationship between activity and internalising problems was significantly stronger for boys than for girls.,"[{'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Wheatley', 'Affiliation': 'Wellcome Centre for Integrative Neuroimaging, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Wassenaar', 'Affiliation': 'Wellcome Centre for Integrative Neuroimaging, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Piergiorgio', 'Initials': 'P', 'LastName': 'Salvan', 'Affiliation': 'Wellcome Centre for Integrative Neuroimaging, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Beale', 'Affiliation': 'Centre for Movement, Occupational and Rehabilitation Sciences, Oxford Institute of Nursing, Midwifery and Allied Health Research, Oxford Brookes University, Oxford, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Nichols', 'Affiliation': 'Nuffield Department of Population Health, Big Data Institute, University of Oxford, Oxford, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Dawes', 'Affiliation': 'Centre for Movement, Occupational and Rehabilitation Sciences, Oxford Institute of Nursing, Midwifery and Allied Health Research, Oxford Brookes University, Oxford, UK.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Johansen-Berg', 'Affiliation': 'Wellcome Centre for Integrative Neuroimaging, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK.'}]",BMJ open sport & exercise medicine,['10.1136/bmjsem-2020-000819']
2040,33088780,"Comparison of ""Lenticular Process of Incus Replacement Prosthesis [LPIRP]"" with ""Conventional Autologous Tissue Ossiculoplasty Techniques"" in Lenticular Process of Incus (LPI) Necrosis.","To compare the outcome of ossiculoplasty using 'lenticular process of incus replacement prosthesis [LPIRP]' with that of 'conventional autologous tissue ossiculoplasty techniques' in patients with lenticular process of incus necrosis [LPI] in terms of: 1. Hearing results. 2. Graft take-up. 3. Complications like extrusion. Total 16 patients found intraoperatively to have LPI necrosis were allocated randomly using (simple random sampling technique) in two groups. Total 8 patients in group A underwent ossicular chain reconstruction using titanium prosthesis-LPIRP (manufactured by Decibel's gold prosthesis pvt. ltd.) and total 8 patients in group B underwent ossicular chain reconstruction using autologous cartilage/cortical bone. At the end of 4 weeks status of graft uptake was assessed and follow up pure tone audiogram [PTA] was performed at average 4th, 12th and 24th post-operative week. No significant difference in mean hearing gain (i.e. air-bone conduction gap closure) between two groups at 1 month, 3 months and 6 months post operatively [p > 0.05]. However postoperative 3 months and 6 months results have better air bone conduction gap closure in group A as compared to group B. Titanium LPIRP prosthesis can be a good alternative in patients undergoing ossiculoplasty where autografts are not available for ossicular reconstruction or there is inadequate surgical expertise for remodelling autologous bone/cartilage.",2020,However postoperative 3 months and 6 months results have better air bone conduction gap closure in group A as compared to group B. Titanium LPIRP prosthesis can be a good alternative in patients undergoing ossiculoplasty where autografts are not available for ossicular reconstruction or there is inadequate surgical expertise for remodelling autologous bone/cartilage.,"['Total 16 patients found intraoperatively to have LPI necrosis', 'patients with lenticular process of incus necrosis [LPI']","['conventional autologous tissue ossiculoplasty techniques', 'Titanium LPIRP prosthesis', 'replacement prosthesis [LPIRP', ""ossicular chain reconstruction using titanium prosthesis-LPIRP (manufactured by Decibel's gold prosthesis pvt"", 'ossicular chain reconstruction using autologous cartilage/cortical bone']","['mean hearing gain (i.e. air-bone conduction gap closure', 'graft uptake']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0268647', 'cui_str': 'Lysinuric protein intolerance'}, {'cui': 'C0027540', 'cui_str': 'Necrosis'}, {'cui': 'C0229403', 'cui_str': 'Structure of lenticular process of incus'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C1261340', 'cui_str': 'Reconstruction of ossicular chain'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0040302', 'cui_str': 'Titanium'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0439497', 'cui_str': 'dB'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0007301', 'cui_str': 'Cartilage tissue'}, {'cui': 'C0222652', 'cui_str': 'Cortex of bone'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0005935', 'cui_str': 'Bone conduction'}, {'cui': 'C0061928', 'cui_str': 'GTPase-Activating Protein'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}]",16.0,0.0150281,However postoperative 3 months and 6 months results have better air bone conduction gap closure in group A as compared to group B. Titanium LPIRP prosthesis can be a good alternative in patients undergoing ossiculoplasty where autografts are not available for ossicular reconstruction or there is inadequate surgical expertise for remodelling autologous bone/cartilage.,"[{'ForeName': 'Rahulkumar Vijaykumar', 'Initials': 'RV', 'LastName': 'Shah', 'Affiliation': 'Department of E.N.T. & Head-Neck Surgery, Baroda Medical College, Vadodara, Gujarat India.'}, {'ForeName': 'Rahul Rajivkumar', 'Initials': 'RR', 'LastName': 'Gupta', 'Affiliation': 'Department of E.N.T. & Head-Neck Surgery, Baroda Medical College, Vadodara, Gujarat India.'}, {'ForeName': 'Ranjan G', 'Initials': 'RG', 'LastName': 'Aiyer', 'Affiliation': 'Department of E.N.T. & Head-Neck Surgery, Baroda Medical College, Vadodara, Gujarat India.'}]",Indian journal of otolaryngology and head and neck surgery : official publication of the Association of Otolaryngologists of India,['10.1007/s12070-020-02017-2']
2041,33088865,"Comparison of Clinical, Functional, and Radiological Outcomes of Total Knee Arthroplasty Using Conventional and Patient-Specific Instrumentation.","Background


Recently, patient-specific instrumentation (PSI) systems have been developed in order to increase the accuracy of component positioning during total knee arthroplasty (TKA); however, the findings of previous studies are controversial in this regard. In the current randomized clinical study, the outcomes of computer tomography (CT)-based PS (patient specific)-guided TKA were compared to the results of conventional instrumentation (CVI) TKA. The guides were designed on the basis of distal femoral and proximal tibial pin orientation of the conventional related guides.
Methods


The present study was carried out on 24 TKA candidates randomly assigned to two PSI (n=12) and CVI (n=12) groups. The patients were postoperatively followed for 2 years. Then, the hip-knee-ankle angle (HKAA), femoral component flexion, and orientation of components in the coronal plane were measured. In addition, the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index and Knee Society Score (KSS) questionnaire were completed for all the patients.
Results


The rate of the outliers of the HKAA was higher in the CVI group (41.7% and 8.3%;  P=0.077 ); nevertheless, the difference was not significant in this regard. The rate of the outliers of other radiographic measurements and operational time were similar in both groups. Furthermore, there was no significant difference between the two groups in terms of the WOMAC and KSS.
Conclusion


The CT-based PS-guided TKA may result in the improved postoperative mechanical alignment of the limb and should be considered in complicated TKAs. However, future studies should investigate whether the results of PSI TKA support the considerably higher costs of this technique.",2020,"Furthermore, there was no significant difference between the two groups in terms of the WOMAC and KSS.
",['24 TKA candidates randomly assigned to two PSI (n=12) and CVI (n=12) groups'],"['computer tomography (CT)-based PS (patient specific)-guided TKA', 'Total Knee Arthroplasty Using Conventional and Patient-Specific Instrumentation', 'conventional instrumentation (CVI) TKA', 'PSI TKA']","['rate of the outliers of other radiographic measurements and operational time', 'rate of the outliers of the HKAA', 'hip-knee-ankle angle (HKAA), femoral component flexion, and orientation of components in the coronal plane', 'Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index and Knee Society Score (KSS) questionnaire']","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0021632', 'cui_str': 'instrumentation'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0040395', 'cui_str': 'Diagnostic tomography'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0021632', 'cui_str': 'instrumentation'}]","[{'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0449434', 'cui_str': 'Femoral component'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0029266', 'cui_str': 'Orientation'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C4551585', 'cui_str': 'Coronal plane'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",24.0,0.0495866,"Furthermore, there was no significant difference between the two groups in terms of the WOMAC and KSS.
","[{'ForeName': 'Soheil', 'Initials': 'S', 'LastName': 'Mehdipour', 'Affiliation': 'Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohamad', 'Initials': 'M', 'LastName': 'Qoreishi', 'Affiliation': 'Boneoint and elated issues esearch enter, Akhtar ospital, Shaheed Beheshti niversity of edical ciences, Tehran, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Keipourfard', 'Affiliation': 'Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",The archives of bone and joint surgery,['10.22038/abjs.2020.41571.2124']
2042,33089003,"Effectiveness of a brief manualized intervention, Managing Cancer and Living Meaningfully (CALM), adapted to the Italian cancer care setting: Study protocol for a single-blinded randomized controlled trial.","Patients with advanced cancer suffer from psychosocial distress that may impair quality of life and that may be ameliorated by psychotherapeutic treatment. We describe here the methodology of a randomized controlled trial (RCT) to assess the effectiveness of a novel, brief, semi-structured psychotherapeutic intervention to reduce distress and increase well-being in patients with advanced or metastatic cancer. The intervention, called Managing Cancer and Living Meaningfully (CALM), was originally developed in Canada and we are now testing its Italian adaptation (CALM-IT). The study is a single-blinded phase III RCT with assessment at baseline, 3 and 6 months with two conditions: CALM-IT versus a nonspecific supportive intervention (SPI). Eligibility criteria include: ≥ 18 years of age; fluency in the Italian language; no cognitive deficit, and diagnosis of advanced or metastatic cancer with an expected survival of 12-18 months. CALM-IT includes up to 12 sessions, delivered over 6 months and covers 4 domains: i) Symptom Management and Communication with Health Care Providers; ii) Changes in Self and Relations with Close Others; iii) Sense of Meaning and Purpose; and iv) the Future and Mortality. The primary outcome is difference in severity of depressive symptoms between treatment arm and the primary endpoint is 6 months. The secondary endpoint is 3 months and secondary outcomes are: generalized anxiety, distress about dying and death, demoralization, spiritual well-being, attachment security, posttraumatic growth, communication with partners, quality of life, and satisfaction with clinical care. If shown to be effective, CALM-IT can be implemented nationally to relieve distress and to promote psychological well-being in patients with advanced cancer.",2020,"The secondary endpoint is 3 months and secondary outcomes are: generalized anxiety, distress about dying and death, demoralization, spiritual well-being, attachment security, posttraumatic growth, communication with partners, quality of life, and satisfaction with clinical care.","['patients with advanced or metastatic cancer', 'patients with advanced cancer', 'Patients with advanced cancer suffer from psychosocial distress', 'Eligibility criteria include: ≥ 18 years of age; fluency in the Italian language; no cognitive deficit, and diagnosis of advanced or metastatic cancer with an expected survival of 12-18 months']","['CALM-IT versus a nonspecific supportive intervention (SPI', 'brief manualized intervention, Managing Cancer and Living Meaningfully (CALM', 'Health Care Providers', 'semi-structured psychotherapeutic intervention']","['severity of depressive symptoms', 'generalized anxiety, distress about dying and death, demoralization, spiritual well-being, attachment security, posttraumatic growth, communication with partners, quality of life, and satisfaction with clinical care']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0022275', 'cui_str': 'Italian language'}, {'cui': 'C0009241', 'cui_str': 'Cognitive disorder'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0150157', 'cui_str': 'Calming'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0033978', 'cui_str': 'Psychotherapeutic agent'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0233498', 'cui_str': 'Demoralization'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C4704809', 'cui_str': 'Posttraumatic Growth'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]",,0.0687231,"The secondary endpoint is 3 months and secondary outcomes are: generalized anxiety, distress about dying and death, demoralization, spiritual well-being, attachment security, posttraumatic growth, communication with partners, quality of life, and satisfaction with clinical care.","[{'ForeName': 'Rosangela', 'Initials': 'R', 'LastName': 'Caruso', 'Affiliation': 'Institute of Psychiatry, Department of Biomedical and Specialty Surgical Sciences, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Maria Giulia', 'Initials': 'MG', 'LastName': 'Nanni', 'Affiliation': 'Institute of Psychiatry, Department of Biomedical and Specialty Surgical Sciences, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Rodin', 'Affiliation': 'Department of Supportive Care, Princess Margaret Cancer Center, University Health Network, 16th Floor, 610 University Avenue, Toronto, ON M5G 2M9, Canada.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Hales', 'Affiliation': 'Department of Supportive Care, Princess Margaret Cancer Center, University Health Network, 16th Floor, 610 University Avenue, Toronto, ON M5G 2M9, Canada.'}, {'ForeName': 'Carmine', 'Initials': 'C', 'LastName': 'Malfitano', 'Affiliation': 'Department of Supportive Care, Princess Margaret Cancer Center, University Health Network, 16th Floor, 610 University Avenue, Toronto, ON M5G 2M9, Canada.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'De Padova', 'Affiliation': 'Psycho-Oncology Unit, Istituto Scientifico Romagnolo per Lo Studio e La Cura Dei Tumori (IRST), IRCCS, Meldola, Italy.'}, {'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Bertelli', 'Affiliation': 'Psycho-Oncology Unit, Istituto Scientifico Romagnolo per Lo Studio e La Cura Dei Tumori (IRST), IRCCS, Meldola, Italy.'}, {'ForeName': 'Martino Belvederi', 'Initials': 'MB', 'LastName': 'Murri', 'Affiliation': 'Institute of Psychiatry, Department of Biomedical and Specialty Surgical Sciences, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Bovero', 'Affiliation': 'Clinical Psychology Unit, Department of Neuroscience, University of Turin, ""Città Della Salute e Della Scienza"" Hospital, Turin, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Miniotti', 'Affiliation': 'Clinical Psychology Unit, Department of Neuroscience, University of Turin, ""Città Della Salute e Della Scienza"" Hospital, Turin, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Leombruni', 'Affiliation': 'Clinical Psychology Unit, Department of Neuroscience, University of Turin, ""Città Della Salute e Della Scienza"" Hospital, Turin, Italy.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Zerbinati', 'Affiliation': 'Institute of Psychiatry, Department of Biomedical and Specialty Surgical Sciences, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Silvana', 'Initials': 'S', 'LastName': 'Sabato', 'Affiliation': 'Institute of Psychiatry, Department of Biomedical and Specialty Surgical Sciences, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Grassi', 'Affiliation': 'Institute of Psychiatry, Department of Biomedical and Specialty Surgical Sciences, University of Ferrara, Ferrara, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Contemporary clinical trials communications,['10.1016/j.conctc.2020.100661']
2043,33089004,The Sickle Cell Pro-Inflammatory Response to Interval Testing Study (SPRINTS) in children and young adults with sickle cell anemia - Study design and methodological strategies.,"The impact of sickle cell anemia (SCA) and its complications on physical functioning and cardiopulmonary/aerobic fitness in affected individuals is significant. Although limited data support the safety of maximal cardiopulmonary exercise testing (CPET) for children and adults with SCA, the safety of submaximal moderate and high intensity, and longer duration, exercise in this population is not clear. The Sickle Cell Pro-Inflammatory Response to Interval Testing Study (SPRINTS) is a multicenter, randomized, prospective trial. SPRINTS leverages unique collaborations between investigators in pediatric hematology and exercise science to evaluate the impact of exercise intensity on the acute phase inflammatory response to exercise and changes in airway dynamics in children and young adults with SCA. Here we describe the study design and methodological strategies employed in SPRINTS, including an exercise challenge that mimics real-life patterns of childhood physical activity, characterized by multiple moderate and high intensity brief bouts of exercise interspersed with rest periods. Primary outcomes comprise pre- and post-exercise biomarkers of inflammation and endothelial dysfunction and spirometry. Secondary outcomes include assessment of physical activity and functioning, genomic studies and near-infrared spectroscopy measurements to assess tissue oxygenation status during exercise. SPRINTS aims to enroll 70 subjects with SCA and 70 matched, healthy controls. We anticipate that data from SPRINTS will address gaps in our understanding of exercise responses and safety in SCA and support the future development of evidence-based, exercise prescription guidelines in this population.",2020,"The Sickle Cell Pro-Inflammatory Response to Interval Testing Study (SPRINTS) is a multicenter, randomized, prospective trial.","['children and young adults with sickle cell anemia', 'children and adults with SCA', 'enroll 70 subjects with SCA and 70 matched, healthy controls', 'children and young adults with SCA']",['maximal cardiopulmonary exercise testing (CPET'],"['pre- and post-exercise biomarkers of inflammation and endothelial dysfunction and spirometry', 'assessment of physical activity and functioning, genomic studies and near-infrared spectroscopy measurements to assess tissue oxygenation status during exercise', 'physical functioning and cardiopulmonary/aerobic fitness']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0002895', 'cui_str': 'Sickling disorder due to hemoglobin S'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C2959886', 'cui_str': 'Cardiopulmonary exercise test'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0856169', 'cui_str': 'Endothelial dysfunction'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0017428', 'cui_str': 'Genome'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0376519', 'cui_str': 'Near-infrared spectroscopy'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C1444752', 'cui_str': 'Status during'}]",70.0,0.0787219,"The Sickle Cell Pro-Inflammatory Response to Interval Testing Study (SPRINTS) is a multicenter, randomized, prospective trial.","[{'ForeName': 'R I', 'Initials': 'RI', 'LastName': 'Liem', 'Affiliation': ""Division of Hematology, Oncology & Stem Cell Transplant, Ann & Robert H. Lurie Children's Hospital of Chicago, 225 East Chicago Avenue, Box 30, Chicago, IL, 60611, USA.""}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Baynard', 'Affiliation': 'Integrative Physiology Laboratory, University of Illinois at Chicago, 1640 West Roosevelt Road, Chicago, IL, 60608, USA.'}, {'ForeName': 'L L', 'Initials': 'LL', 'LastName': 'Hsu', 'Affiliation': 'Division of Pediatric Hematology/Oncology, University of Illinois at Chicago, 840 South Wood Street, MC 856, Chicago, IL, 60612, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Garofano', 'Affiliation': 'Division of Pediatric Cardiology, Columbia University Medical Center, 3959 Broadway, New York, NY, 10032, USA.'}, {'ForeName': 'N S', 'Initials': 'NS', 'LastName': 'Green', 'Affiliation': 'Division of Pediatric Hematology, Oncology and Stem Cell Transplantation, Columbia University Medical Center, 3959 Broadway, New York, NY, 10032, USA.'}, {'ForeName': 'J S', 'Initials': 'JS', 'LastName': 'Hankins', 'Affiliation': ""Department of Hematology, St. Jude Children's Research Hospital, 262 Danny Thomas Place, MS 800, Memphis, TN, 38105, USA.""}, {'ForeName': 'K K', 'Initials': 'KK', 'LastName': 'Ness', 'Affiliation': ""Department of Epidemiology and Cancer Control, St. Jude Children's Research Hospital, 262 Danny Thomas Place, MS 735, Memphis, TN, 38105, USA.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rodeghier', 'Affiliation': 'Rodeghier Consulting, Inc, 6244 North Nordica Avenue, Chicago, IL, 60631, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Radom-Aizik', 'Affiliation': 'Pediatric Exercise and Genomics Research Center, University of California Irvine, 101 Academy, Irvine, CA, 92617, USA.'}]",Contemporary clinical trials communications,['10.1016/j.conctc.2020.100668']
2044,33092565,"Effectiveness of upgraded maternity waiting homes and local leader training on improving institutional births: a cluster-randomized controlled trial in Jimma, Ethiopia.","BACKGROUND


Maternity waiting homes (MWHs), residential spaces for pregnant women close to obstetric care facilities, are being used to tackle physical barriers to access. However, their effectiveness has not been rigorously assessed. The objective of this cluster randomized trial was to evaluate the effectiveness of functional MWHs combined with community mobilization by trained local leaders in improving institutional births in Jimma Zone, Ethiopia.
METHODS


A pragmatic, parallel arm cluster-randomized trial was conducted in three districts. Twenty-four primary health care units (PHCUs) were randomly assigned to either (i) upgraded MWHs combined with local leader training on safe motherhood strategies, (ii) local leader training only, or (iii) usual care. Data were collected using repeat cross-sectional surveys at baseline and 21 months after intervention to assess the effect of intervention on the primary outcome, defined as institutional births, at the individual level. Women who had a pregnancy outcome (livebirth, stillbirth or abortion) 12 months prior to being surveyed were eligible for interview. Random effects logistic regression was used to evaluate the effect of the interventions.
RESULTS


Data from 24 PHCUs and 7593 women were analysed using intention-to-treat. The proportion of institutional births was comparable at baseline between the three arms. At endline, institutional births were slightly higher in the MWH + training (54% [n = 671/1239]) and training only arms (65% [n = 821/1263]) compared to usual care (51% [n = 646/1271]). MWH use at baseline was 6.7% (n = 256/3784) and 5.8% at endline (n = 219/3809). Both intervention groups exhibited a non-statistically significant higher odds of institutional births compared to usual care (MWH +  & leader training odds ratio [OR] = 1.09, 97.5% confidence interval [CI] 0.67 to 1.75; leader training OR = 1.37, 97.5% CI 0.85 to 2.22).
CONCLUSIONS


Both the combined MWH +  & leader training and the leader training alone intervention led to a small but non-significant increase in institutional births when compared to usual care. Implementation challenges and short intervention duration may have hindered intervention effectiveness. Nevertheless, the observed increases suggest the interventions have potential to improve women's use of maternal healthcare services. Optimal distances at which MWHs are most beneficial to women need to be investigated.
TRIAL REGISTRATION


The trial was retrospectively registered on the Clinical Trials website ( https://clinicaltrials.gov ) on 3rd October 2017. The trial identifier is NCT03299491 .",2020,"Both intervention groups exhibited a non-statistically significant higher odds of institutional births compared to usual care (MWH +  & leader training odds ratio [OR] = 1.09, 97.5% confidence interval [CI] 0.67 to 1.75; leader training OR = 1.37, 97.5% CI 0.85 to 2.22).
","['Women who had a pregnancy outcome (livebirth, stillbirth or abortion) 12\u2009months prior to being surveyed were eligible for interview', 'Data from 24 PHCUs and 7593 women', 'Twenty-four primary health care units (PHCUs', 'Maternity waiting homes (MWHs), residential spaces for pregnant women close to obstetric care facilities', 'institutional births in Jimma Zone, Ethiopia']","['MWHs combined with local leader training on safe motherhood strategies, (ii) local leader training only, or (iii) usual care', 'upgraded maternity waiting homes and local leader training', 'combined MWH +  & leader training', 'functional MWHs combined with community mobilization by trained local leaders']","['proportion of institutional births', 'institutional births']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}, {'cui': 'C0419373', 'cui_str': 'Livebirth'}, {'cui': 'C0595939', 'cui_str': 'Stillbirth'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0015024', 'cui_str': 'Ethiopia'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0337490', 'cui_str': 'Motherhood'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}]","[{'cui': 'C0005615', 'cui_str': 'Birth'}]",7593.0,0.107904,"Both intervention groups exhibited a non-statistically significant higher odds of institutional births compared to usual care (MWH +  & leader training odds ratio [OR] = 1.09, 97.5% confidence interval [CI] 0.67 to 1.75; leader training OR = 1.37, 97.5% CI 0.85 to 2.22).
","[{'ForeName': 'Jaameeta', 'Initials': 'J', 'LastName': 'Kurji', 'Affiliation': 'School of Epidemiology and Public Health, University of Ottawa, 600 Peter Morand Crescent, Ottawa, Ontario, K1G 5Z3, Canada. jkurj022@uottawa.ca.'}, {'ForeName': 'Lakew Abebe', 'Initials': 'LA', 'LastName': 'Gebretsadik', 'Affiliation': 'Department of Health, Behaviour & Society, Jimma University, Jimma Town, Jimma Zone, Ethiopia.'}, {'ForeName': 'Muluemebet Abera', 'Initials': 'MA', 'LastName': 'Wordofa', 'Affiliation': 'Department of Population & Family Health, Jimma University, Jimma Town, Jimma Zone, Ethiopia.'}, {'ForeName': 'Sudhakar', 'Initials': 'S', 'LastName': 'Morankar', 'Affiliation': 'Department of Health, Behaviour & Society, Jimma University, Jimma Town, Jimma Zone, Ethiopia.'}, {'ForeName': 'Kunuz Haji', 'Initials': 'KH', 'LastName': 'Bedru', 'Affiliation': 'Jimma Zone Health Office, Jimma Town, Jimma Zone, Ethiopia.'}, {'ForeName': 'Gebeyehu', 'Initials': 'G', 'LastName': 'Bulcha', 'Affiliation': 'Jimma Zone Health Office, Jimma Town, Jimma Zone, Ethiopia.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Bergen', 'Affiliation': 'Faculty of Health Sciences, University of Ottawa, 600 Peter Morand Crescent, Ottawa, Ontario, K1G 5Z3, Canada.'}, {'ForeName': 'Getachew', 'Initials': 'G', 'LastName': 'Kiros', 'Affiliation': 'Department of Health, Behaviour & Society, Jimma University, Jimma Town, Jimma Zone, Ethiopia.'}, {'ForeName': 'Yisalemush', 'Initials': 'Y', 'LastName': 'Asefa', 'Affiliation': 'Department of Health Economics, Management & Policy, Jimma University, Jimma Town, Jimma Zone, Ethiopia.'}, {'ForeName': 'Shifera', 'Initials': 'S', 'LastName': 'Asfaw', 'Affiliation': 'Department of Health, Behaviour & Society, Jimma University, Jimma Town, Jimma Zone, Ethiopia.'}, {'ForeName': 'Abebe', 'Initials': 'A', 'LastName': 'Mamo', 'Affiliation': 'Department of Health, Behaviour & Society, Jimma University, Jimma Town, Jimma Zone, Ethiopia.'}, {'ForeName': 'Erko', 'Initials': 'E', 'LastName': 'Endale', 'Affiliation': 'Department of Health, Behaviour & Society, Jimma University, Jimma Town, Jimma Zone, Ethiopia.'}, {'ForeName': 'Kednapa', 'Initials': 'K', 'LastName': 'Thavorn', 'Affiliation': 'Ottawa Hospital Research Institute General Campus, University of Ottawa, Ottawa, Canada.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Labonte', 'Affiliation': 'School of Epidemiology and Public Health, University of Ottawa, 600 Peter Morand Crescent, Ottawa, Ontario, K1G 5Z3, Canada.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Taljaard', 'Affiliation': 'Ottawa Hospital Research Institute Civic Campus, University of Ottawa, Ottawa, Canada.'}, {'ForeName': 'Manisha A', 'Initials': 'MA', 'LastName': 'Kulkarni', 'Affiliation': 'School of Epidemiology and Public Health, University of Ottawa, 600 Peter Morand Crescent, Ottawa, Ontario, K1G 5Z3, Canada.'}]",BMC public health,['10.1186/s12889-020-09692-4']
2045,33092573,"The efficacy of specialised rehabilitation using the Op-reha Guide for cancer patients in palliative care units: protocol of a multicentre, randomised controlled trial (JORTC-RHB02).","BACKGROUND


Although rehabilitation is recommended for terminal cancer patients, the specific components and methods of such programs are poorly documented. No studies to date have examined the effectiveness of rehabilitation for terminal cancer patients. This study aims to evaluate the efficacy of a new intervention for rehabilitation therapists, using the Op-reha Guide (Guide to Optimal and Patient-Centred Rehabilitation Practice for Patients in Palliative Care Units [PCUs]) in rehabilitation practice. This guide consists of recommended actions and attitudes for rehabilitation therapists and aims to optimise therapists' actions according to the patient's needs and condition. It shares goals with terminal cancer patients to maintain their activities of daily living (ADL).
METHODS


This study uses a multicentre, prospective, randomised controlled trial (RCT) design with two parallel groups in PCUs where specialised rehabilitation will be routinely performed for terminal cancer patients by rehabilitation therapists. Participants will be randomised (1:1) to intervention (the Op-reha Guide) and control groups (usual rehabilitation). We will then conduct an observational study in PCUs that do not perform specialised rehabilitation for terminal cancer patients; this will be considered the usual care group, and the efficacy of usual rehabilitation will be quantitatively evaluated. Inclusion criteria are hospitalisation in PCU, European Cooperative Oncology Group Performance Status of 2 or 3, and clinical estimation of life expectancy of 3 weeks or more. Patients with severe symptom burden will be excluded. We hypothesise that the Op-reha Guide will be more effective in maintaining the ADL of terminal cancer patients hospitalised in PCUs than usual rehabilitation. The primary endpoint is defined as the change in (total) modified Barthel Index from baseline to Day 22. Quality of life will be a secondary endpoint. In total, 135 patients will be recruited from 16 Japanese sites between July 2019 and December 2021.
DISCUSSION


This will be the first trial to evaluate the efficacy of specialised rehabilitation for terminal cancer patients hospitalised in PCUs, and will contribute to the evidence on the efficacy of implementing rehabilitation for terminal cancer patients.
TRIAL REGISTRATION


UMIN-CTR, UMIN000037298 R000042525 (date of registration 7 July 2019).",2020,"This will be the first trial to evaluate the efficacy of specialised rehabilitation for terminal cancer patients hospitalised in PCUs, and will contribute to the evidence on the efficacy of implementing rehabilitation for terminal cancer patients.
","['terminal cancer patients', '135 patients will be recruited from 16 Japanese sites between July 2019 and December 2021', 'terminal cancer patients hospitalised in PCUs than usual rehabilitation', 'terminal cancer patients by rehabilitation therapists', 'Patients with severe symptom burden will be excluded', 'terminal cancer patients hospitalised in PCUs', 'Patients in Palliative Care Units [PCUs]) in rehabilitation practice', 'cancer patients in palliative care units']",['specialised rehabilitation'],"['Quality of life', 'change in (total) modified Barthel Index']","[{'cui': 'C0741884', 'cui_str': 'End stage cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0436345', 'cui_str': 'Symptom severe'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}]",135.0,0.111102,"This will be the first trial to evaluate the efficacy of specialised rehabilitation for terminal cancer patients hospitalised in PCUs, and will contribute to the evidence on the efficacy of implementing rehabilitation for terminal cancer patients.
","[{'ForeName': 'Nanako', 'Initials': 'N', 'LastName': 'Nishiyama', 'Affiliation': 'Graduate School of Comprehensive Rehabilitation, Osaka Prefecture University, 3-7-30, Habikino, Habikino-city, Osaka, 583-8555, Japan. rapeblossoms-chi75@outlook.jp.'}, {'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Matsuda', 'Affiliation': 'Department of Psychosomatic Internal Medicine, National Hospital Organization Kinki-Chuo Chest Medical Centre, Sakai, Japan.'}, {'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Fujiwara', 'Affiliation': 'IMSUT Hospital of the Institute of Medical Science, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Keisuke', 'Initials': 'K', 'LastName': 'Ariyoshi', 'Affiliation': 'JORTC Data Centre, NPO, Tokyo, Japan.'}, {'ForeName': 'Shunsuke', 'Initials': 'S', 'LastName': 'Oyamada', 'Affiliation': 'JORTC Data Centre, NPO, Tokyo, Japan.'}, {'ForeName': 'Keiichi', 'Initials': 'K', 'LastName': 'Narita', 'Affiliation': 'Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Ryouhei', 'Initials': 'R', 'LastName': 'Ishii', 'Affiliation': 'Graduate School of Comprehensive Rehabilitation, Osaka Prefecture University, 3-7-30, Habikino, Habikino-city, Osaka, 583-8555, Japan.'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Iwase', 'Affiliation': 'Department of Emergency & Palliative Medicine, Faculty of Medicine, Saitama Medical University, Saitama, Japan.'}]",BMC palliative care,['10.1186/s12904-020-00670-6']
2046,33092583,The effectiveness of the combined problem-based learning (PBL) and case-based learning (CBL) teaching method in the clinical practical teaching of thyroid disease.,"BACKGROUND


This study aimed to evaluate the effectiveness and efficiency of PBL-CBL combined teaching in thyroid surgery and make observations from the students' perspectives, based on their satisfaction with the learning process.
METHODS


We prospectively enrolled 354 fourth-year students majoring in clinical medicine, along with 232 residents, from September 2014 to June 2019. These participants were randomly allocated into either the combined PBL-CBL teaching group or the traditional lecture-based classroom group to attend a course about thyroid nodules. Both pre- and post-class quizzes were conducted. An anonymous questionnaire was also administered to both groups to evaluate the students' perceptions and experiences. We compared the two teaching methods among all the students as well as with the fourth-year students and residents in subgroups.
RESULTS


The traditional group's pre-class quiz scores were significantly higher than the PBL-CBL group's (as determined by a two-tailed t-test at a 95% confidence interval, T = 16.483, P < 0.001). After class, in the PBL-CBL group, the mean total quiz score and the basic knowledge and case analysis scores increased significantly (P < 0.001). The PBL-CBL group's performance improvement was significantly higher than the traditional group's (increasing from 52.76 to 70.51 vs. from 67.03 to 71.97). Furthermore, the scores for learning motivation, understanding, student-teacher interaction, the final examination, communication skills, clinical thinking skills, self-learning skills, teamwork skills, and knowledge absorption, as measured by the survey, were significantly higher in the PBL-CBL group than in the traditional group (P < 0.001). Meanwhile, the survey scores representing the amount of students' free time the course consumed were significantly lower in the PBL-CBL group than in the traditional group (P < 0.001).
CONCLUSIONS


PBL combined with CBL may be an effective method for improving medical students' and residents' performance and enhancing their clinical skills.",2020,"The traditional group's pre-class quiz scores were significantly higher than the PBL-CBL group's (as determined by a two-tailed t-test at a 95% confidence interval, T = 16.483, P < 0.001).","['enrolled 354 fourth-year students majoring in clinical medicine, along with 232 residents, from September 2014 to June 2019', 'students as well as with the fourth-year students and residents in subgroups']","['PBL-CBL combined teaching', 'combined problem-based learning (PBL) and case-based learning (CBL) teaching method', 'combined PBL-CBL teaching group or the traditional lecture-based classroom group to attend a course about thyroid nodules', 'PBL-CBL', 'PBL combined with CBL']","['pre-class quiz scores', 'mean total quiz score and the basic knowledge and case analysis scores', 'scores for learning motivation, understanding, student-teacher interaction, the final examination, communication skills, clinical thinking skills, self-learning skills, teamwork skills, and knowledge absorption']","[{'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0008964', 'cui_str': 'Medicine, Clinical'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}]","[{'cui': 'C3472614', 'cui_str': 'Plasmablastic lymphoma'}, {'cui': 'C0008163', 'cui_str': 'Chlorambucil'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0243013', 'cui_str': 'Problem-Based Learning'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0039403', 'cui_str': 'Teaching Methods'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0040137', 'cui_str': 'Thyroid nodule'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0870313', 'cui_str': 'Communication skills'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C4279942', 'cui_str': 'Thinking Skills'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}]",,0.0227956,"The traditional group's pre-class quiz scores were significantly higher than the PBL-CBL group's (as determined by a two-tailed t-test at a 95% confidence interval, T = 16.483, P < 0.001).","[{'ForeName': 'Wanjun', 'Initials': 'W', 'LastName': 'Zhao', 'Affiliation': 'Department of Thyroid Surgery, West China Hospital, Sichuan University, Chengdu, 610041, China.'}, {'ForeName': 'Linye', 'Initials': 'L', 'LastName': 'He', 'Affiliation': 'Department of Thyroid Surgery, West China Hospital, Sichuan University, Chengdu, 610041, China.'}, {'ForeName': 'Wenyi', 'Initials': 'W', 'LastName': 'Deng', 'Affiliation': 'West China School of Medicine, Sichuan University, Chengdu, 610041, China.'}, {'ForeName': 'Jingqiang', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Department of Thyroid Surgery, West China Hospital, Sichuan University, Chengdu, 610041, China.'}, {'ForeName': 'Anping', 'Initials': 'A', 'LastName': 'Su', 'Affiliation': 'Department of Thyroid Surgery, West China Hospital, Sichuan University, Chengdu, 610041, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Key Laboratory of Transplant Engineering and Immunology, MOH; West China-Washington Mitochondria and Metabolism Research Center, West China Hospital, Sichuan University, 37 Guo Xue Xiang, Chengdu, 610041, NO, China. nankai1989@foxmail.com.'}]",BMC medical education,['10.1186/s12909-020-02306-y']
2047,33092591,Salbutamol use in relation to maintenance bronchodilator efficacy in COPD: a prospective subgroup analysis of the EMAX trial.,"BACKGROUND


Short-acting β 2 -agonist (SABA) bronchodilators help alleviate symptoms in chronic obstructive pulmonary disease (COPD) and may be a useful marker of symptom severity. This analysis investigated whether SABA use impacts treatment differences between maintenance dual- and mono-bronchodilators in patients with COPD.
METHODS


The Early MAXimisation of bronchodilation for improving COPD stability (EMAX) trial randomised symptomatic patients with low exacerbation risk not receiving inhaled corticosteroids 1:1:1 to once-daily umeclidinium/vilanterol 62.5/25 μg, once-daily umeclidinium 62.5 μg or twice-daily salmeterol 50 μg for 24 weeks. Pre-specified subgroup analyses stratified patients by median baseline SABA use (low, < 1.5 puffs/day; high, ≥1.5 puffs/day) to examine change from baseline in trough forced expiratory volume in 1 s (FEV 1 ), change in symptoms (Transition Dyspnoea Index [TDI], Evaluating Respiratory Symptoms-COPD [E-RS]), daily SABA use and exacerbation risk. A post hoc analysis used fractional polynomial modelling with continuous transformations of baseline SABA use covariates.
RESULTS


At baseline, patients in the high SABA use subgroup (mean: 3.91 puffs/day, n = 1212) had more severe airflow limitation, were more symptomatic and had worse health status versus patients in the low SABA use subgroup (0.39 puffs/day, n = 1206). Patients treated with umeclidinium/vilanterol versus umeclidinium demonstrated statistically significant improvements in trough FEV 1  at Week 24 in both SABA subgroups (59-74 mL; p < 0.001); however, only low SABA users demonstrated significant improvements in TDI (high: 0.27 [p = 0.241]; low: 0.49 [p = 0.025]) and E-RS (high: 0.48 [p = 0.138]; low: 0.60 [p = 0.034]) scores. By contrast, significant reductions in mean SABA puffs/day with umeclidinium/vilanterol versus umeclidinium were observed only in high SABA users (high: - 0.56 [p < 0.001]; low: - 0.10 [p = 0.132]). Similar findings were observed when comparing umeclidinium/vilanterol and salmeterol. Fractional polynomial modelling showed baseline SABA use ≥4 puffs/day resulted in smaller incremental symptom improvements with umeclidinium/vilanterol versus umeclidinium compared with baseline SABA use < 4 puffs/day.
CONCLUSIONS


In high SABA users, there may be a smaller difference in treatment response between dual- and mono-bronchodilator therapy; the reasons for this require further investigation. SABA use may be a confounding factor in bronchodilator trials and in high SABA users; changes in SABA use may be considered a robust symptom outcome.
FUNDING


GlaxoSmithKline (study number 201749 [NCT03034915]).",2020,"Patients treated with umeclidinium/vilanterol versus umeclidinium demonstrated statistically significant improvements in trough FEV 1  at Week 24 in both SABA subgroups (59-74 mL; p < 0.001); however, only low SABA users demonstrated significant improvements in TDI (high: 0.27 [p = 0.241]; low: 0.49 [p = 0.025]) and E-RS (high: 0.48 [p = 0.138]; low: 0.60 [p = 0.034]) scores.","['symptomatic patients with low exacerbation risk not receiving inhaled corticosteroids 1:1:1 to once-daily umeclidinium/vilanterol 62.5/25', 'chronic obstructive pulmonary disease (COPD', 'patients with COPD', 'COPD']","['SABA', 'agonist (SABA) bronchodilators', 'Salbutamol', 'umeclidinium 62.5\u2009μg or twice-daily salmeterol', 'umeclidinium/vilanterol versus umeclidinium']","['severe airflow limitation', 'TDI', 'trough FEV', 'mean SABA puffs/day with umeclidinium/vilanterol versus umeclidinium', 'change in symptoms (Transition Dyspnoea Index [TDI], Evaluating Respiratory Symptoms-COPD [E-RS]), daily SABA use and exacerbation risk', 'health status']","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C3709478', 'cui_str': 'umeclidinium / vilanterol'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}]","[{'cui': 'C0047120', 'cui_str': 'serotonin azidobenzamidine'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0006280', 'cui_str': 'Bronchodilator agent'}, {'cui': 'C0001927', 'cui_str': 'Albuterol'}, {'cui': 'C3661274', 'cui_str': 'umeclidinium'}, {'cui': 'C4517836', 'cui_str': '62.5'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0073992', 'cui_str': 'salmeterol'}, {'cui': 'C3709478', 'cui_str': 'umeclidinium / vilanterol'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0231999', 'cui_str': 'Airflow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0205976', 'cui_str': 'Toluene di-isocyanate-containing product'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0047120', 'cui_str': 'serotonin azidobenzamidine'}, {'cui': 'C1533107', 'cui_str': 'Puff - unit of product usage'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3709478', 'cui_str': 'umeclidinium / vilanterol'}, {'cui': 'C3661274', 'cui_str': 'umeclidinium'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0037090', 'cui_str': 'Respiratory symptom'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0018759', 'cui_str': 'Health status'}]",,0.389575,"Patients treated with umeclidinium/vilanterol versus umeclidinium demonstrated statistically significant improvements in trough FEV 1  at Week 24 in both SABA subgroups (59-74 mL; p < 0.001); however, only low SABA users demonstrated significant improvements in TDI (high: 0.27 [p = 0.241]; low: 0.49 [p = 0.025]) and E-RS (high: 0.48 [p = 0.138]; low: 0.60 [p = 0.034]) scores.","[{'ForeName': 'F', 'Initials': 'F', 'LastName': 'Maltais', 'Affiliation': 'Centre de Pneumologie, Institut Universitaire de Cardiologie et de Pneumologie de Québec, Université Laval, Québec, QC, Canada. Francois.Maltais@fmed.ulaval.ca.'}, {'ForeName': 'I P', 'Initials': 'IP', 'LastName': 'Naya', 'Affiliation': 'GSK, Brentford, Middlesex, UK.'}, {'ForeName': 'C F', 'Initials': 'CF', 'LastName': 'Vogelmeier', 'Affiliation': 'Department of Medicine, Pulmonary and Critical Care Medicine, University Medical Center Giessen and Marburg, Philipps-Universität Marburg, Member of the German Center for Lung Research (DZL), Marburg, Germany.'}, {'ForeName': 'I H', 'Initials': 'IH', 'LastName': 'Boucot', 'Affiliation': 'GSK, Brentford, Middlesex, UK.'}, {'ForeName': 'P W', 'Initials': 'PW', 'LastName': 'Jones', 'Affiliation': 'GSK, Brentford, Middlesex, UK.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Bjermer', 'Affiliation': 'Respiratory Medicine and Allergology, Lund University, Lund, Sweden.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Tombs', 'Affiliation': 'Precise Approach Ltd, contingent worker on assignment at GSK, Stockley Park West, Uxbridge, Middlesex, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Compton', 'Affiliation': 'GSK, Brentford, Middlesex, UK.'}, {'ForeName': 'D A', 'Initials': 'DA', 'LastName': 'Lipson', 'Affiliation': 'Respiratory Clinical Sciences, GSK, Collegeville, PA, USA.'}, {'ForeName': 'E M', 'Initials': 'EM', 'LastName': 'Kerwin', 'Affiliation': 'Clinical Research Institute of Southern Oregon, Medford, OR, USA.'}]",Respiratory research,['10.1186/s12931-020-01451-8']
2048,33092705,NYHA Functional Classification and Outcomes After Transcatheter Mitral Valve Repair in Heart Failure: The COAPT Trial.,"OBJECTIVES


The aim of this study was to evaluate the outcomes of MitraClip implantation versus guideline-directed medical therapy (GDMT) in patients with secondary mitral regurgitation (SMR) according to baseline functional status as assessed by the widely used New York Heart Association (NYHA) functional classification.
BACKGROUND


Patients with heart failure (HF) and impaired functional status at baseline have poor prognosis. Whether the effects of transcatheter repair of secondary SMR in patients with HF are influenced by baseline functional status is unknown.
METHODS


In the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) trial, patients with HF with moderate to severe or severe SMR who remained symptomatic despite maximally tolerated GDMT were randomized to MitraClip implantation versus GDMT alone. Outcomes were evaluated according to baseline functional status as assessed using the NYHA functional classification. The primary endpoint of interest was the rate of death or HF-related hospitalization (HFH) at 2 years in time-to-first-event analyses.
RESULTS


Among 613 randomized patients, 240 were in NYHA functional class II (39.2%), 322 were in NYHA functional class III (52.5%), and 51 were in ambulatory NYHA functional class IV (8.3%). Rates of death or HFH were progressively higher with increasing NYHA functional class. Compared with GDMT alone, MitraClip implantation resulted in lower 2-year rates of death or HFH consistently in patients in NYHA functional class II (39.7% vs. 63.7%; hazard ratio [HR]: 0.54; 95% confidence interval [CI]: 0.37 to 0.77), NYHA functional class III (46.6% vs. 65.5%; HR: 0.60; 95% CI: 0.45 to 0.82), and NYHA functional class IV (66.7% vs. 85.2%; HR: 0.55; 95% CI: 0.28 to 1.10; p interaction  = 0.86). Greater improvements in quality of life at 2 years were observed in patients treated with the MitraClip compared with GDMT irrespective of baseline functional status.
CONCLUSIONS


The NYHA functional classification provides prognostic utility in patients with HF and moderate to severe or severe SMR. In the COAPT trial, the benefits of MitraClip implantation were consistent in patients with better or worse functional status as assessed by NYHA functional class. (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation [The COAPT Trial] [COAPT]; NCT01626079).",2020,"Greater improvements in quality of life at 2 years were observed in patients treated with the MitraClip compared with GDMT irrespective of baseline functional status.
","['Heart\xa0Failure Patients', 'Failure', 'patients with HF', '613 randomized patients, 240 were in NYHA functional class II (39.2%), 322 were in NYHA functional class III (52.5%), and 51 were in ambulatory NYHA functional class IV (8.3', 'patients with secondary mitral regurgitation (SMR', 'Heart\xa0Failure Patients with Functional Mitral Regurgitation) trial, patients with HF with moderate to severe or severe SMR who remained symptomatic despite maximally tolerated GDMT', 'patients with HF and moderate to severe or severe SMR', 'Patients with heart failure (HF']","['transcatheter repair of secondary SMR', 'MitraClip implantation', 'Percutaneous Therapy', 'MitraClip Percutaneous Therapy', 'MitraClip implantation versus GDMT', 'MitraClip', 'Functional Mitral Regurgitation', 'MitraClip implantation versus guideline-directed medical therapy (GDMT', 'GDMT alone, MitraClip implantation', 'Transcatheter Mitral Valve Repair in Heart']","['2-year rates of death or HFH', 'quality of life', 'Rates of death or HFH', 'rate of death or HF-related hospitalization (HFH']","[{'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0441886', 'cui_str': 'Class 2'}, {'cui': 'C4517712', 'cui_str': '322'}, {'cui': 'C0441887', 'cui_str': 'Class 3'}, {'cui': 'C4517802', 'cui_str': '52.5'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0441888', 'cui_str': 'Class 4'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0026266', 'cui_str': 'Mitral valve regurgitation'}, {'cui': 'C0340369', 'cui_str': 'Functional mitral regurgitation'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}]","[{'cui': 'C0442343', 'cui_str': 'Transcatheter approach'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0026266', 'cui_str': 'Mitral valve regurgitation'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}, {'cui': 'C0340369', 'cui_str': 'Functional mitral regurgitation'}, {'cui': 'C2921039', 'cui_str': 'Transcatheter mitral valve repair'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]",613.0,0.0682714,"Greater improvements in quality of life at 2 years were observed in patients treated with the MitraClip compared with GDMT irrespective of baseline functional status.
","[{'ForeName': 'Gennaro', 'Initials': 'G', 'LastName': 'Giustino', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'JoAnn', 'Initials': 'J', 'LastName': 'Lindenfeld', 'Affiliation': 'Advanced Heart Failure and Cardiac Transplantation Section, Vanderbilt Heart and Vascular Institute, Nashville, Tennessee.'}, {'ForeName': 'William T', 'Initials': 'WT', 'LastName': 'Abraham', 'Affiliation': 'Division of Cardiovascular Medicine, The Ohio State University College of Medicine, Columbus, Ohio.'}, {'ForeName': 'Saibal', 'Initials': 'S', 'LastName': 'Kar', 'Affiliation': 'Los Robles Regional Medical Center, Thousand Oaks, California; Bakersfield Heart Hospital, Bakersfield, California.'}, {'ForeName': 'D Scott', 'Initials': 'DS', 'LastName': 'Lim', 'Affiliation': 'Division of Cardiology, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Grayburn', 'Affiliation': 'Baylor University Medical Center, Baylor Heart and Vascular Institute, Dallas, Texas.'}, {'ForeName': 'Samir R', 'Initials': 'SR', 'LastName': 'Kapadia', 'Affiliation': 'Department of Cardiovascular Medicine, Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Cohen', 'Affiliation': 'University of Missouri-Kansas City School of Medicine, Kansas City, Missouri.'}, {'ForeName': 'Lak N', 'Initials': 'LN', 'LastName': 'Kotinkaduwa', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': 'Neil J', 'Initials': 'NJ', 'LastName': 'Weissman', 'Affiliation': 'MedStar Health Research Institute, Washington, DC; Georgetown University, Washington, DC.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Mack', 'Affiliation': 'Baylor Scott and White Heart Hospital Plano, Plano, Texas.'}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York; Clinical Trials Center, Cardiovascular Research Foundation, New York, New York. Electronic address: gregg.stone@mountsinai.org.'}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2020.06.058']
2049,33092707,Baseline Functional Capacity and Transcatheter Mitral Valve Repair in Heart Failure With Secondary Mitral Regurgitation.,"OBJECTIVES


The aim of this study was to determine the prognostic utility of baseline functional status and its impact on the outcomes of transcatheter mitral valve repair (TMVr) in patients with heart failure (HF) with secondary mitral regurgitation (SMR).
BACKGROUND


The COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation) trial demonstrated that TMVr with the MitraClip in patients with HF with moderate to severe or severe SMR improved health-related quality of life. The clinical utility of a baseline assessment of functional status for evaluating prognosis and identifying candidates likely to derive a robust benefit from TMVr has not been previously studied in patients with HF with SMR.
METHODS


The COAPT study was a multicenter, randomized, controlled, parallel-group, open-label trial of TMVr with the MitraClip plus guideline-directed medical therapy (GDMT) versus GDMT alone in patients with HF, left ventricular ejection fraction 20% to 50%, and moderate to severe or severe SMR. Baseline functional status was assessed by 6-min walk distance (6MWD).
RESULTS


Patients with 6MWD less than the median (240 m) were older, were more likely to be female, and had more comorbidities. After multivariate modeling, age (p = 0.005), baseline hemoglobin (p = 0.007), and New York Heart Association functional class III/IV symptoms (p < 0.0001) were independent clinical predictors of 6MWD. Patients with 6MWD <240 m versus ≥240 m had a higher unadjusted and adjusted rate of the 2-year composite of all-cause death or HF hospitalization (64.4% vs. 48.6%; adjusted hazard ratio: 1.53; 95% confidence interval: 1.19 to 1.98; p = 0.001). However, there was no interaction between baseline 6MWD and the relative effectiveness of TMVr plus GDMT versus GDMT alone with respect to the composite endpoint (p = 0.633).
CONCLUSIONS


Baseline assessment of functional capacity by 6MWD was a powerful discriminator of prognosis in patients with HF with SMR. TMVr with the MitraClip provided substantial improvements in clinical outcomes for this population irrespective of baseline functional capacity.",2020,"After multivariate modeling, age (p = 0.005), baseline hemoglobin (p = 0.007), and New York Heart Association functional class III/IV symptoms (p < 0.0001) were independent clinical predictors of 6MWD.","['Patients with 6MWD', 'Valve Repair in Heart', 'patients with HF with SMR', 'patients with HF, left ventricular ejection fraction 20% to 50%, and moderate to severe or severe SMR', 'Patients with 6MWD less than the median (240 m) were older', 'Heart', 'Failure With Secondary Mitral\xa0Regurgitation', 'patients with heart failure (HF) with secondary mitral regurgitation (SMR', 'Failure Patients With Functional Mitral Regurgitation']","['TMVr with the MitraClip plus guideline-directed medical therapy (GDMT) versus GDMT alone', 'TMVr', 'transcatheter mitral valve repair (TMVr', 'MitraClip Percutaneous Therapy']","['New York Heart Association functional class III/IV symptoms', 'baseline hemoglobin', '2-year composite of all-cause death or HF hospitalization', 'Baseline Functional Capacity and Transcatheter Mitral', 'severe or severe SMR improved health-related quality of life', 'Baseline functional status', '6-min walk distance (6MWD']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0026266', 'cui_str': 'Mitral valve regurgitation'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0340369', 'cui_str': 'Functional mitral regurgitation'}]","[{'cui': 'C2921039', 'cui_str': 'Transcatheter mitral valve repair'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0441887', 'cui_str': 'Class 3'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0442343', 'cui_str': 'Transcatheter approach'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0026266', 'cui_str': 'Mitral valve regurgitation'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}]",,0.104687,"After multivariate modeling, age (p = 0.005), baseline hemoglobin (p = 0.007), and New York Heart Association functional class III/IV symptoms (p < 0.0001) were independent clinical predictors of 6MWD.","[{'ForeName': 'Umar I', 'Initials': 'UI', 'LastName': 'Malik', 'Affiliation': 'Department of Cardiology, The Permanente Medical Group, San Francisco, California.'}, {'ForeName': 'Andrew P', 'Initials': 'AP', 'LastName': 'Ambrosy', 'Affiliation': 'Department of Cardiology, The Permanente Medical Group, San Francisco, California; Division of Research, Kaiser Permanente Northern California, Oakland, California.'}, {'ForeName': 'Ivy A', 'Initials': 'IA', 'LastName': 'Ku', 'Affiliation': 'Department of Cardiology, The Permanente Medical Group, San Francisco, California.'}, {'ForeName': 'Jacob M', 'Initials': 'JM', 'LastName': 'Mishell', 'Affiliation': 'Department of Cardiology, The Permanente Medical Group, San Francisco, California.'}, {'ForeName': 'Saibal', 'Initials': 'S', 'LastName': 'Kar', 'Affiliation': 'Los Robles Regional Medical Center, Thousand Oaks, California; Bakersfield Heart Hospital, Bakersfield, California.'}, {'ForeName': 'D Scott', 'Initials': 'DS', 'LastName': 'Lim', 'Affiliation': 'Division of Cardiology, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Brian K', 'Initials': 'BK', 'LastName': 'Whisenant', 'Affiliation': 'Intermountain Medical Center Heart Institute, Salt Lake City, Utah.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Cohen', 'Affiliation': 'University of Missouri-Kansas City School of Medicine, Kansas City, Missouri.'}, {'ForeName': 'Suzanne V', 'Initials': 'SV', 'LastName': 'Arnold', 'Affiliation': ""University of Missouri-Kansas City School of Medicine, Kansas City, Missouri; Saint Luke's Mid America Heart Institute, Kansas City, Missouri.""}, {'ForeName': 'Lak N', 'Initials': 'LN', 'LastName': 'Kotinkaduwa', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': 'JoAnn', 'Initials': 'J', 'LastName': 'Lindenfeld', 'Affiliation': 'Vanderbilt Heart and Vascular Institute, Nashville, Tennessee.'}, {'ForeName': 'William T', 'Initials': 'WT', 'LastName': 'Abraham', 'Affiliation': 'Division of Cardiovascular Medicine, The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Mack', 'Affiliation': 'Baylor Scott & White Health, Plano, Texas.'}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York. Electronic address: gregg.stone@mountsinai.org.'}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2020.07.030']
2050,33092714,Reply: The Randomized TIDES-ACS Trial.,,2020,,[],[],[],[],[],[],,0.0561738,,"[{'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Collet', 'Affiliation': ''}, {'ForeName': 'Pim A L', 'Initials': 'PAL', 'LastName': 'Tonino', 'Affiliation': ''}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Mizukami', 'Affiliation': ''}, {'ForeName': 'Nico H J', 'Initials': 'NHJ', 'LastName': 'Pijls', 'Affiliation': ''}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'De Bruyne', 'Affiliation': ''}, {'ForeName': 'Pasi P', 'Initials': 'PP', 'LastName': 'Karjalainen', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2020.09.009']
2051,33092715,The Randomized TIDES-ACS Trial.,,2020,,[],[],[],[],[],[],,0.070276,,"[{'ForeName': 'Toshiki', 'Initials': 'T', 'LastName': 'Kuno', 'Affiliation': ''}, {'ForeName': 'Mai', 'Initials': 'M', 'LastName': 'Takahashi', 'Affiliation': ''}, {'ForeName': 'Rikuta', 'Initials': 'R', 'LastName': 'Hamaya', 'Affiliation': ''}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2020.08.004']
2052,33092758,"Cardiac Resynchronization Therapy Guided by Echocardiography, MRI, and CT Imaging: A Randomized Controlled Study.","OBJECTIVES


This study evaluated if selecting the left ventricular (LV) target segment by echocardiography-derived late mechanical activation, with access to multimodality imaging for scar and venous anatomy, could help to increase responder rates to cardiac resynchronization therapy (CRT).
BACKGROUND


LV lead placement is important for clinical outcome, but the optimal strategy for LV lead placement in CRT is still debated.
METHODS


This study conducted a prospective, blinded randomized controlled trial on 102 patients with indication for CRT (27% women, 46% with ischemic cardiomyopathy, 63% in New York Heart Association functional class III, 74% with left bundle branch block, and with mean ejection fraction of 23%). Optimal LV lead location was defined as the latest mechanically activated available segment (free of transmural scar), determined by radial strain echocardiography, cardiac computed tomography, and cardiac magnetic resonance (n = 70). The primary endpoint was reduction of LV end-systolic volume by ≥15% at 6 months post-implantation.
RESULTS


Patients were followed for 47 ± 21 months. Based on imaging, optimal or adjacent lead placement was feasible in 96% of all cases and was obtained in 83% of the intervention group versus 80% of the control group. Fifty-six percent of the patients were LV end-systolic volume responders compared with the control group (55%) (p = 0.96), and 71% improved ≥1 New York Heart Association functional class (74% vs. 67%; p = 0.43). Death or heart failure hospitalization within 2 years occurred in 6% (2% of the intervention group vs. 10% of the control group; p = 0.07).
CONCLUSIONS


Radial strain-guided LV lead placement, in combination with multimodality imaging, did not result in increased clinical or echocardiographic response, nor in a significant reduction of death or heart failure hospitalization. (Combining Myocardial Strain and Cardiac CT to Optimize Left Ventricular Lead Placement in CRT Treatment [CRT Clinic]; NCT01426321).",2020,"Based on imaging, optimal or adjacent lead placement was feasible in 96% of all cases and was obtained in 83% of the intervention group versus 80% of the control group.","['Patients were followed for 47 ± 21\xa0months', '102 patients with indication for CRT (27% women, 46% with ischemic cardiomyopathy, 63% in New York Heart Association functional class III, 74% with left bundle branch block, and with mean ejection fraction of 23']","['Cardiac Resynchronization Therapy Guided by Echocardiography, MRI, and CT Imaging']","['≥1 New York Heart Association functional class', 'reduction of LV end-systolic volume', 'Death or heart failure hospitalization', 'death or heart failure hospitalization', 'clinical or echocardiographic response', 'LV end-systolic volume responders']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C1167956', 'cui_str': 'Cardiac resynchronisation therapy'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0349782', 'cui_str': 'Generalized ischemic myocardial dysfunction'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0441887', 'cui_str': 'Class 3'}, {'cui': 'C0006384', 'cui_str': 'Bundle branch block'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}]","[{'cui': 'C1167956', 'cui_str': 'Cardiac resynchronisation therapy'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}]","[{'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0455832', 'cui_str': 'Left ventricular end-systolic cavity size'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0080308', 'cui_str': 'Ventricular End-Systolic Volume'}]",102.0,0.085663,"Based on imaging, optimal or adjacent lead placement was feasible in 96% of all cases and was obtained in 83% of the intervention group versus 80% of the control group.","[{'ForeName': 'Rasmus', 'Initials': 'R', 'LastName': 'Borgquist', 'Affiliation': 'Cardiology Division, Arrhythmia Section, Department of Clinical Sciences Lund, Skane University Hospital, Lund University, Lund, Sweden. Electronic address: rasmus.borgquist@med.lu.se.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Carlsson', 'Affiliation': 'Clinical Physiology Section, Department of Clinical Sciences Lund, Skane University Hospital, Lund University, Lund, Sweden.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Markstad', 'Affiliation': 'Radiology Section, Department of Clinical Sciences Lund, Skane University Hospital, Lund University, Lund, Sweden.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Werther-Evaldsson', 'Affiliation': 'Heart Failure and Valvular Heart Disease Section, Skane University Hospital, Lund, Sweden.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Ostenfeld', 'Affiliation': 'Clinical Physiology Section, Department of Clinical Sciences Lund, Skane University Hospital, Lund University, Lund, Sweden; Radiology Section, Department of Clinical Sciences Lund, Skane University Hospital, Lund University, Lund, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Roijer', 'Affiliation': 'Heart Failure and Valvular Heart Disease Section, Skane University Hospital, Lund, Sweden.'}, {'ForeName': 'Zoltan', 'Initials': 'Z', 'LastName': 'Bakos', 'Affiliation': 'Cardiology Division, Arrhythmia Section, Department of Clinical Sciences Lund, Skane University Hospital, Lund University, Lund, Sweden.'}]",JACC. Clinical electrophysiology,['10.1016/j.jacep.2020.05.011']
2053,33092803,Deep neuromuscular block does not improve surgical conditions in patients receiving sevoflurane anaesthesia for laparoscopic renal surgery.,"BACKGROUND


Deep neuromuscular block is associated with improved working conditions during laparoscopic surgery when propofol is used as a general anaesthetic. However, whether deep neuromuscular block yields similar beneficial effects when anaesthesia is maintained using volatile inhalation anaesthesia has not been systematically investigated. Volatile anaesthetics, as opposed to intravenous agents, potentiate muscle relaxation, which potentially reduces the need for deep neuromuscular block to obtain optimal surgical conditions. We examined whether deep neuromuscular block improves surgical conditions over moderate neuromuscular block during sevoflurane anaesthesia.
METHODS


In this single-centre, prospective, randomised, double-blind study, 98 patients scheduled for elective renal surgery were randomised to receive deep (post-tetanic count 1-2 twitches) or a moderate neuromuscular block (train-of-four 1-2 twitches). Anaesthesia was maintained with sevoflurane and titrated to bispectral index values between 40 and 50. Pneumoperitoneum pressure was maintained at 12 mm Hg. The primary outcome was the difference in surgical conditions, scored at 15 min intervals by one of eight blinded surgeons using a 5-point Leiden-Surgical Rating Scale (L-SRS) that scores the quality of the surgical field from extremely poor 1  to optimal 5 .
RESULTS


Deep neuromuscular block did not improve surgical conditions compared with moderate neuromuscular block: mean (standard deviation) L-SRS 4.8 (0.3) vs 4.8 (0.4), respectively (P=0.94). Secondary outcomes, including unplanned postoperative readmissions and prolonged hospital admission, were not significantly different.
CONCLUSIONS


During sevoflurane anaesthesia, deep neuromuscular block did not improve surgical conditions over moderate neuromuscular block in normal-pressure laparoscopic renal surgery.
CLINICAL TRIAL REGISTRATION


NL7844 (www.trialregister.nl).",2020,"RESULTS


Deep neuromuscular block did not improve surgical conditions compared with moderate neuromuscular block: mean (standard deviation) L-SRS 4.8 (0.3) vs 4.8 (0.4), respectively (P=0.94).","['patients receiving sevoflurane anaesthesia for laparoscopic renal surgery', '98 patients scheduled for elective renal surgery']","['sevoflurane anaesthesia, deep neuromuscular block', 'propofol', 'moderate neuromuscular block (train-of-four 1-2 twitches', 'deep neuromuscular block', 'sevoflurane']","['unplanned postoperative readmissions and prolonged hospital admission', 'Pneumoperitoneum pressure', 'surgical conditions', 'surgical conditions, scored at 15 min intervals by one of eight blinded surgeons using a 5-point Leiden-Surgical Rating Scale (L-SRS) that scores the quality of the surgical field from extremely poor 1  to optimal 5 ']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0194053', 'cui_str': 'Kidney operation'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}]","[{'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0235062', 'cui_str': 'Induction of neuromuscular blockade'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0231530', 'cui_str': 'Muscle twitch'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0032320', 'cui_str': 'Pneumoperitoneum'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0205403', 'cui_str': 'Extreme'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}]",98.0,0.487235,"RESULTS


Deep neuromuscular block did not improve surgical conditions compared with moderate neuromuscular block: mean (standard deviation) L-SRS 4.8 (0.3) vs 4.8 (0.4), respectively (P=0.94).","[{'ForeName': 'G H Maarten', 'Initials': 'GHM', 'LastName': 'Honing', 'Affiliation': 'Department of Anaesthesiology, Leiden University Medical Centre, Leiden, The Netherlands.'}, {'ForeName': 'Christian H', 'Initials': 'CH', 'LastName': 'Martini', 'Affiliation': 'Department of Anaesthesiology, Leiden University Medical Centre, Leiden, The Netherlands.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Olofsen', 'Affiliation': 'Department of Anaesthesiology, Leiden University Medical Centre, Leiden, The Netherlands.'}, {'ForeName': 'Rob F M', 'Initials': 'RFM', 'LastName': 'Bevers', 'Affiliation': 'Department of Urology, Leiden University Medical Centre, Leiden, The Netherlands.'}, {'ForeName': 'Volkert A L', 'Initials': 'VAL', 'LastName': 'Huurman', 'Affiliation': 'Department of Transplant Surgery and Transplant Centre, Leiden University Medical Centre, Leiden, The Netherlands.'}, {'ForeName': 'Ian P J', 'Initials': 'IPJ', 'LastName': 'Alwayn', 'Affiliation': 'Department of Transplant Surgery and Transplant Centre, Leiden University Medical Centre, Leiden, The Netherlands.'}, {'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'van Velzen', 'Affiliation': 'Department of Anaesthesiology, Leiden University Medical Centre, Leiden, The Netherlands.'}, {'ForeName': 'Marieke', 'Initials': 'M', 'LastName': 'Niesters', 'Affiliation': 'Department of Anaesthesiology, Leiden University Medical Centre, Leiden, The Netherlands.'}, {'ForeName': 'Leon P H J', 'Initials': 'LPHJ', 'LastName': 'Aarts', 'Affiliation': 'Department of Anaesthesiology, Leiden University Medical Centre, Leiden, The Netherlands.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Dahan', 'Affiliation': 'Department of Anaesthesiology, Leiden University Medical Centre, Leiden, The Netherlands.'}, {'ForeName': 'Martijn', 'Initials': 'M', 'LastName': 'Boon', 'Affiliation': 'Department of Anaesthesiology, Leiden University Medical Centre, Leiden, The Netherlands. Electronic address: m.boon@lumc.nl.'}]",British journal of anaesthesia,['10.1016/j.bja.2020.09.024']
2054,33092805,"Impact of intraoperative goal-directed fluid therapy on major morbidity and mortality after transthoracic oesophagectomy: a multicentre, randomised controlled trial.","BACKGROUND


Transthoracic oesophagectomy is associated with major morbidity and mortality, which may be reduced by goal-directed therapy (GDT). The aim of this multicentre, RCT was to evaluate the impact of intraoperative GDT on major morbidity and mortality in patients undergoing transthoracic oesophagectomy.
METHODS


Adult patients undergoing transthoracic oesophagectomy were randomised to receive either minimally invasive intraoperative GDT (stroke volume variation <8%, plus systolic BP maintained >90 mm Hg by pressors as necessary) or haemodynamic management left to the discretion of attending senior anaesthetists (control group; systolic BP >90 mm Hg alone). The primary outcome was the incidence of death or major complications (reoperation for bleeding, anastomotic leakage, pneumonia, reintubation, >48 h ventilation). A Cox proportional hazard model was used to examine whether the effects of GDT on morbidity and mortality were independent of other potential confounders.
RESULTS


A total of 232 patients (80.6% male; age range: 36-83 yr) were randomised to either GDT (n=115) or to the control group (n=117). After surgery, major morbidity and mortality were less frequent in 22/115 (19.1%) subjects randomised to GDT, compared with 41/117 (35.0%) subjects assigned to the control group {absolute risk reduction: 15.9% (95% confidence interval [CI]: 4.7-27.2%); P=0.006}. GDT was also associated with fewer episodes of atrial fibrillation (odds ratio [OR]: 0.18 [95% CI: 0.05-0.65]), respiratory failure (OR: 0.27 [95% CI: 0.09-0.83]), use of mini-tracheotomy (OR: 0.29 [95% CI: 0.10-0.81]), and readmission to ICU (OR: 0.09 [95% CI: 0.01-0.67]). GDT was independently associated with morbidity and mortality (hazard ratio: 0.51 [95% CI: 0.30-0.87]; P=0.013).
CONCLUSIONS


Intraoperative GDT may reduce major morbidity and mortality, and shorten hospital stay, after transthoracic oesophagectomy.
CLINICAL TRIAL REGISTRATION


UMIN000018705.",2020,"After surgery, major morbidity and mortality were less frequent in 22/115 (19.1%) subjects randomised to GDT, compared with 41/117 (35.0%) subjects assigned to the control group {absolute risk reduction: 15.9% (95% confidence interval [CI]: 4.7-27.2%); P=0.006}. GDT was also associated with fewer episodes of atrial fibrillation (odds ratio [OR]: 0.18 [95% CI: 0.05-0.65]), respiratory failure (OR: 0.27 [95% CI: 0.09-0.83]), use of mini-tracheotomy (OR: 0.29 [95% CI: 0.10-0.81]), and readmission to ICU (OR: 0.09","['patients undergoing transthoracic oesophagectomy', 'Adult patients undergoing transthoracic oesophagectomy', '232 patients (80.6% male; age range: 36-83 yr']","['intraoperative goal-directed fluid therapy', 'Intraoperative GDT', 'Transthoracic oesophagectomy', 'GDT', 'intraoperative GDT', 'transthoracic oesophagectomy', 'minimally invasive intraoperative GDT (stroke volume variation <8%, plus systolic BP maintained >90 mm Hg by pressors as necessary) or haemodynamic management left to the discretion of attending senior anaesthetists (control group; systolic BP >90 mm Hg alone', 'RCT']","['major morbidity and mortality, and shorten hospital stay', 'episodes of atrial fibrillation', 'morbidity and mortality', 'major morbidity and mortality', 'respiratory failure', 'incidence of death or major complications (reoperation for bleeding, anastomotic leakage, pneumonia, reintubation, >48 h ventilation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205503', 'cui_str': 'Transthoracic approach'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0016286', 'cui_str': 'Therapy, Fluid'}, {'cui': 'C1271494', 'cui_str': 'Goal directed therapy'}, {'cui': 'C0205503', 'cui_str': 'Transthoracic approach'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C4518814', 'cui_str': 'Stroke volume variation'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0439083', 'cui_str': '>90'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0441636', 'cui_str': 'Surgical shortening - action'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0919691', 'cui_str': 'Anastomotic leak'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0860359', 'cui_str': 'Reintubate'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}]",232.0,0.492345,"After surgery, major morbidity and mortality were less frequent in 22/115 (19.1%) subjects randomised to GDT, compared with 41/117 (35.0%) subjects assigned to the control group {absolute risk reduction: 15.9% (95% confidence interval [CI]: 4.7-27.2%); P=0.006}. GDT was also associated with fewer episodes of atrial fibrillation (odds ratio [OR]: 0.18 [95% CI: 0.05-0.65]), respiratory failure (OR: 0.27 [95% CI: 0.09-0.83]), use of mini-tracheotomy (OR: 0.29 [95% CI: 0.10-0.81]), and readmission to ICU (OR: 0.09","[{'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Mukai', 'Affiliation': 'Department of Anaesthesiology, Osaka City University Graduate School of Medicine, Osaka City, Osaka, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Suehiro', 'Affiliation': 'Department of Anaesthesiology, Osaka City University Graduate School of Medicine, Osaka City, Osaka, Japan. Electronic address: suehirokoichi@yahoo.co.jp.'}, {'ForeName': 'Ryota', 'Initials': 'R', 'LastName': 'Watanabe', 'Affiliation': 'Department of Anaesthesiology, Osaka City General Hospital, Osaka City, Osaka, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Juri', 'Affiliation': 'Department of Anaesthesiology, Osaka City University Graduate School of Medicine, Osaka City, Osaka, Japan.'}, {'ForeName': 'Yasue', 'Initials': 'Y', 'LastName': 'Hayashi', 'Affiliation': 'Department of Anaesthesiology, Sumitomo Hospital, Osaka City, Osaka, Japan.'}, {'ForeName': 'Katsuaki', 'Initials': 'K', 'LastName': 'Tanaka', 'Affiliation': 'Department of Anaesthesiology, Osaka City University Graduate School of Medicine, Osaka City, Osaka, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Fujii', 'Affiliation': 'Department of Cardiovascular Anaesthesiology, Osaka Rosai Hospital, Sakai City, Osaka, Japan.'}, {'ForeName': 'Naoko', 'Initials': 'N', 'LastName': 'Ohira', 'Affiliation': 'Department of Anaesthesiology, Sumitomo Hospital, Osaka City, Osaka, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Oda', 'Affiliation': 'Department of Anaesthesiology, Osaka City Juso Hospital, Osaka City, Osaka, Japan.'}, {'ForeName': 'Ryu', 'Initials': 'R', 'LastName': 'Okutani', 'Affiliation': 'Department of Anaesthesiology, Osaka City General Hospital, Osaka City, Osaka, Japan.'}, {'ForeName': 'Kiyonobu', 'Initials': 'K', 'LastName': 'Nishikawa', 'Affiliation': 'Department of Anaesthesiology, Osaka City University Graduate School of Medicine, Osaka City, Osaka, Japan.'}]",British journal of anaesthesia,['10.1016/j.bja.2020.08.060']
2055,33092813,Biofeedback versus bilateral transcutaneous posterior tibial nerve stimulation in the treatment of functional non-retentive fecal incontinence in children: A randomized controlled trial.,"BACKGROUND


Biofeedback and transcutaneous posterior tibial nerve stimulation (TPTNS) can be used in treatment of Functional non-retentive fecal incontinence (FNRFI). Aim of this study was to evaluate the early effect of Biofeedback versus (TPTNS) and treatment by Kegal exercises and dietetic regulations in management of (FNRFI) in children.
METHODOLOGY


The current prospective randomized controlled study included 93 children with FNRFI who were randomly allocated into the 3 groups. Group A (n = 28) were treated by dietetic regulation and Kegal exercises. Group B (n = 34) received biofeedback while group C (n = 31) received (TPTNS) for 3 months. Follow up using St' Mark's incontinence score and high resolution manometry was done at 3 and 6 months and compared to the initial records.
RESULTS


There was statistically significant decrease in the incontinence score in Group B and C compared to Group A at 3 and 6 months (p ˂ 0.001). Resting and squeeze pressures showed significant increase group B and C (p ˂ 0.001). Patients in Group B and C showed significant decrease volume of balloon required for 1st sensation (p ˂ 0.001 and 0.034) respectively.
CONCLUSION


Biofeedback is more effective than TPTNS, Kegal exercises and dietetic regulations in treatment of FNRFI in children for short term follow-up.
LEVEL OF EVIDENCE


Level I.
TYPE OF STUDY


Treatment Study.",2020,There was statistically significant decrease in the incontinence score in Group B and C compared to Group A at 3 and 6 months (p ˂ 0.001).,"['functional non-retentive fecal incontinence in children', '93 children with FNRFI', 'children']","['Biofeedback versus (TPTNS', 'biofeedback while group C (n\u202f=\u202f31) received (TPTNS', 'Biofeedback and transcutaneous posterior tibial nerve stimulation (TPTNS', 'dietetic regulation and Kegal exercises', 'Biofeedback versus bilateral transcutaneous posterior tibial nerve stimulation', 'Kegal exercises and dietetic regulations']","['Resting and squeeze pressures', 'volume of balloon required for 1st sensation', 'incontinence score']","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C4303076', 'cui_str': 'Non-retentive fecal incontinence'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0040186', 'cui_str': 'Structure of tibial nerve'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0012180', 'cui_str': 'Dietetics'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}]","[{'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0413258', 'cui_str': 'Barotrauma of descent'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0205435', 'cui_str': 'First'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",93.0,0.0710779,There was statistically significant decrease in the incontinence score in Group B and C compared to Group A at 3 and 6 months (p ˂ 0.001).,"[{'ForeName': 'Emad M', 'Initials': 'EM', 'LastName': 'Abdelrahman', 'Affiliation': 'General Surgery Department, Faculty of Medicine, Benha University, Benha, Egypt. Electronic address: emadsahan301@gmail.com.'}, {'ForeName': 'Mohamed A', 'Initials': 'MA', 'LastName': 'Abdel Ghafar', 'Affiliation': 'Physical Therapy Program, Batterjee Medical College for science and technology, Jeddah, Saudi Arabia.'}, {'ForeName': 'Ali O', 'Initials': 'AO', 'LastName': 'Selim', 'Affiliation': 'Physical Therapy for Surgery Department, Faculty of Physical Therapy, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Olfat I', 'Initials': 'OI', 'LastName': 'Ali', 'Affiliation': 'Department of Basic Science, Faculty of Physical Therapy, Cairo University, Cairo, Egypt.'}, {'ForeName': 'M Ashraf', 'Initials': 'MA', 'LastName': 'Balbaa', 'Affiliation': 'General Surgery Department, Faculty of Medicine, Menoufia University, Shebin Elkom, Egypt.'}]",Journal of pediatric surgery,['10.1016/j.jpedsurg.2020.09.016']
2056,33089368,"Does balneotherapy provide additive effects to physical therapy in patients with subacute supraspinatus tendinopathy? A randomized, controlled, single-blind study.","This study assessed the additional contribution of balneotherapy on physical therapy in subacute supraspinatus tendinopathy. Ninety patients with subacute supraspinatus tendinopathy were included. They were randomized into two equal groups. In group 1 (n = 45), transcutaneous electrical nerve stimulation (TENS), hot pack, ultrasound treatments, and Codman's and range of motion (ROM) exercises were performed. In group 2 (n = 45), balneotherapy was added to the treatment program. In both groups, shoulder active ROM and handgrip strength were measured. Pain was evaluated using a Visual Analogue Scale (VAS) (rest, sleep, movement); functional assessment and quality of life were measured respectively with the Shortened Disabilities of the Arm, Shoulder and Hand Questionnaire (QuickDASH), and the Short Form-36 health survey (SF 36) form. All measurements were repeated before and after 15 treatment sessions. There were statistically significant differences between the before and after assessment parameters in group 1 (all p < 0.05), but not for SF-36 General Health Perceptions, SF-36 Mental Health sub-parameters, and handgrip strengths. However, there were statistically significant differences between all the evaluation before and after the treatment in group 2 (all p < 0.05). When the two groups were compared in terms of alpha gains, statistically significant differences were observed in favor of group 2 in all measurements (all p < 0.05) except for SF-36 Emotional Role Difficulty and SF-36 Mental Health sub-parameters. This study shows that the addition of balneotherapy to physical therapy for subacute supraspinatus tendinopathy can make additional contributions to shoulder ROM, pain, handgrip strength, functional status, and quality of life.",2020,"There were statistically significant differences between the before and after assessment parameters in group 1 (all p < 0.05), but not for SF-36 General Health Perceptions, SF-36 Mental Health sub-parameters, and handgrip strengths.","['Ninety patients with subacute supraspinatus tendinopathy were included', 'subacute supraspinatus tendinopathy', 'patients with subacute supraspinatus tendinopathy']","[""transcutaneous electrical nerve stimulation (TENS), hot pack, ultrasound treatments, and Codman's and range of motion (ROM) exercises"", 'balneotherapy']","['Shortened Disabilities of the Arm, Shoulder and Hand Questionnaire (QuickDASH), and the Short Form-36 health survey', 'Visual Analogue Scale (VAS) (rest, sleep, movement); functional assessment and quality of life', 'shoulder active ROM and handgrip strength', 'SF-36 Emotional Role Difficulty and SF-36 Mental Health sub-parameters', 'Pain', 'SF-36 General Health Perceptions, SF-36 Mental Health sub-parameters, and handgrip strengths']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205365', 'cui_str': 'Subacute'}, {'cui': 'C0584869', 'cui_str': 'Supraspinatus muscle structure'}, {'cui': 'C0151936', 'cui_str': 'Disorder of tendon'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0040654', 'cui_str': 'Percutaneous electrical nerve stimulation'}, {'cui': 'C0444519', 'cui_str': 'Hot'}, {'cui': 'C0184967', 'cui_str': 'Insertion of pack'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0085867', 'cui_str': 'Balneotherapy'}]","[{'cui': 'C0441636', 'cui_str': 'Surgical shortening - action'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",90.0,0.0234664,"There were statistically significant differences between the before and after assessment parameters in group 1 (all p < 0.05), but not for SF-36 General Health Perceptions, SF-36 Mental Health sub-parameters, and handgrip strengths.","[{'ForeName': 'Cihan', 'Initials': 'C', 'LastName': 'Koç', 'Affiliation': 'Bahçe Physical Therapy and Rehabilitation Hospital, Osmaniye, Turkey. pinoyoo@hotmail.com.'}, {'ForeName': 'Emine Eda', 'Initials': 'EE', 'LastName': 'Kurt', 'Affiliation': 'Ahi Evran University Faculty of Medicine, Kırşehir, Turkey.'}, {'ForeName': 'Fatmanur Aybala', 'Initials': 'FA', 'LastName': 'Koçak', 'Affiliation': 'Ahi Evran University Faculty of Medicine, Kırşehir, Turkey.'}, {'ForeName': 'Hatice Rana', 'Initials': 'HR', 'LastName': 'Erdem', 'Affiliation': 'Ahi Evran University Faculty of Medicine, Kırşehir, Turkey.'}, {'ForeName': 'Naime Meriç', 'Initials': 'NM', 'LastName': 'Konar', 'Affiliation': 'Ahi Evran University Faculty of Medicine, Kırşehir, Turkey.'}]",International journal of biometeorology,['10.1007/s00484-020-02032-6']
2057,33089386,Comparative Analysis of Efficacy of Lactic Acid with Ferulic Peel (Combination Peel) Vs Ferulic Peel Alone as a Monotherapy for Photoaging.,"OBJECTIVES


Chemical peels are used to treat fine lines, photoaging, skin discoloration and scars. The objective of this study is to do a comparative analysis of lactic acid 30 % with ferulic peel 12 % (combination peel) versus ferulic peel 12% alone as a monotherapy for photoaging.
MATERIALS AND METHODS


This is a prospective study from Feb 2016 to 2020 in which a total of 60 female patients with ages between 25 and 36 years were treated. Randomization of patients was done for both groups with 30 patients enrolled in each group. The first group of 30 patients was treated with ferulic peel 12 % (hydroalcohol base) with L-ascorbic acid 15% as a sealer alone (i.e., Group A). In the second group, 30 patients were treated with lactic acid 30 % with ferulic peel 12% (hydroalcohol base) with L-ascorbic acid 15% as a sealer (combination peel) (i.e., Group B). Inclusion and exclusion criteria have been defined for the study. Two scales have been used for assessing the results, Allergan Skin Roughness Scale (ASRS) and Allergan Fine Line Scale (AFLS). ASRS and AFLS scores were assessed at pre-treatment (pre) and post-treatment (post 1 month after last peel session) and compared using Student's paired t test and independent t test.
RESULTS


The results showed significant and higher improvement of 27% and 42%, respectively, in ASRS (1.37 ± 0.49 vs. 1.87 ± 0.51, diff = 0.50, 95% CI = 0.24 to 0.76, p < 0.001) and AFLS (1.20 ± 0.41 vs. 2.07 ± 0.58, diff = 0.87, 95% CI = 0.61-1.13, p < 0.001) scores in patients treated with lactic acid and ferulic peel as compared to patients treated with ferulic peel alone. No complications were observed in our study.
CONCLUSION


The study found the combination of lactic acid and ferulic peel significantly more effective than ferulic peel alone in the management of fine lines, photoaging and skin discoloration. The findings of this study may need to be further validated on a larger sample size and multicentric analysis. Initial results of our 4-year study have yielded promising results.
LEVEL OF EVIDENCE III


This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .",2020,"The results showed significant and higher improvement of 27% and 42%, respectively, in ASRS (1.37 ± 0.49 vs. 1.87 ± 0.51, diff = 0.50, 95% CI = 0.24 to 0.76, p < 0.001) and AFLS (1.20 ± 0.41 vs. 2.07 ± 0.58, diff = 0.87, 95% CI = 0.61-1.13, p < 0.001) scores in patients treated with lactic acid and ferulic peel as compared to patients treated with ferulic peel alone.","['Feb 2016 to 2020 in which a total of 60 female patients with ages between 25 and 36 years were treated', '30 patients enrolled in each group']","['ferulic peel 12\xa0% (hydroalcohol base) with L-ascorbic acid', 'lactic acid 30 % with ferulic peel 12% (hydroalcohol base) with L-ascorbic acid', 'ferulic peel 12\xa0% (combination peel) versus ferulic peel', 'ferulic peel alone', 'Lactic Acid with Ferulic Peel (Combination Peel', 'Vs Ferulic Peel Alone', 'lactic acid and ferulic peel']","['ASRS and AFLS scores', 'AFLS', 'fine lines, photoaging and skin discoloration', 'Allergan Skin Roughness Scale (ASRS) and Allergan Fine Line Scale (AFLS']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0237849', 'cui_str': 'Peeling of skin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0064582', 'cui_str': 'lactic acid'}]","[{'cui': 'C0859038', 'cui_str': 'Skin roughness'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205232', 'cui_str': 'Fine'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0151907', 'cui_str': 'Discoloration of skin'}]",60.0,0.0455024,"The results showed significant and higher improvement of 27% and 42%, respectively, in ASRS (1.37 ± 0.49 vs. 1.87 ± 0.51, diff = 0.50, 95% CI = 0.24 to 0.76, p < 0.001) and AFLS (1.20 ± 0.41 vs. 2.07 ± 0.58, diff = 0.87, 95% CI = 0.61-1.13, p < 0.001) scores in patients treated with lactic acid and ferulic peel as compared to patients treated with ferulic peel alone.","[{'ForeName': 'Ashish', 'Initials': 'A', 'LastName': 'Chauhan', 'Affiliation': 'Renaissance clinic, Jaipuria mall, Indirapuram, Ghaziabad, 201010, India.'}, {'ForeName': 'Sukhbir', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': 'Resplendent the cosmetic studio, R-9, Greater Kailash part 1, NewDelhi, 110048, India. sukhi_1@yahoo.com.'}]",Aesthetic plastic surgery,['10.1007/s00266-020-02004-6']
2058,33089408,Bioequivalence study of 20-mg and 100-mg temozolomide capsules (TOZ309 and Temodal ® ) in glioma patients in China.,"BACKGROUND


Temozolomide is an alkylating agent approved by the U.S. Food and Drug Administration in 1999 for the treatment of patients with primary brain tumors. The aim of this study was to confirm the bioequivalence and safety of two strengths (20-100 mg) of generic temozolomide in the form of TOZ039 and Temodal ®  capsules administered to brain tumor patients.
STUDY DESIGN


An open-label, randomized, two-phase, two-period, crossover pharmacokinetic study was performed in a single institution. The reference and test drugs were prescribed at a dose of 150 mg/m 2  daily from days 1 to 5 of a 28-day cycle in the first phase; in the second phase, either a 150- or 200-mg/m 2  dose was prescribed, depending on patient tolerance. On days 1 and 2 of each phase, a fixed 200-mg dose was administered either as ten 20-mg capsules in the first cycle or two 100-mg capsules in the second cycle. Drug administration in the first two days was randomized, i.e., if TOZ309 was administered on day 1, Temodal ®  was administered on day 2, and vice versa. The rest of the prescribed dose was administered in the form of Temodal ®  and spread equally over days 3-5. Blood samples were obtained for pharmacokinetic evaluation on days 1 and 2. Bioequivalence was demonstrated if the geometric means ratio of the three main pharmacokinetic parameters (mean maximum plasma concentration (C max ), area under the concentration-time curve (AUC) 0-t, AUC  0-∞ ) fell within the equivalence boundary of 80-125%.
RESULTS


Twenty-nine glioblastoma multiforme or anaplastic astrocytoma patients were enrolled and dosed with the test and reference formulations under fasting conditions. The 90% confidence interval of the geometric means ratio for C max  (91.08%, 106.18%), AUC 0-t  (98.62%,102.18%), and AUC 0-∞  (98.65%, 102.21%) was well within the 80%-125% range for the 20-mg capsule, as was the C max  (90.49%, 113.32%), AUC 0-t  (99.89%, 104.63%) and AUC 0-∞  (99.99%, 104.67%) for the 100-mg capsule drug product. Additionally, all the secondary pharmacokinetic parameters were not significantly different. After two cycles of treatment, there was no mortality among the 29 patients, treatment-related severe adverse events, or events that would require study discontinuation; however, one significant adverse effect (life-threatening seizures) occurred and was related to disease progression. Adverse events were reported in 82.8% (24/29) patients, and treatment emergent adverse events were reported in 72.4% (21/29) patients.
CONCLUSION


It can be concluded that 20-mg and 100-mg capsules of TOZ309 are bioequivalent to Temodal ®  capsules of the same strength under fasting conditions.
TRIAL REGISTRATION


https://www.chinadrugtrials.org.cn/index.html , CTR2017 0122.",2020,"After two cycles of treatment, there was no mortality among the 29 patients, treatment-related severe adverse events, or events that would require study discontinuation; however, one significant adverse effect (life-threatening seizures) occurred and was related to disease progression.","['Twenty-nine glioblastoma multiforme or anaplastic astrocytoma patients', 'glioma patients in China', 'patients with primary brain tumors']","['Temozolomide', 'generic temozolomide', 'TOZ309', '20-mg and 100-mg temozolomide capsules (TOZ309 and Temodal ® ']","['Adverse events', 'adverse events', 'no mortality', 'severe adverse events', 'adverse effect (life-threatening seizures', 'geometric means ratio of the three main pharmacokinetic parameters (mean maximum plasma concentration (C max ), area under the concentration-time curve (AUC) 0-t, AUC  0-∞ ) fell', 'AUC 0-t', 'geometric means ratio for C max']","[{'cui': 'C0450351', 'cui_str': '29'}, {'cui': 'C0017636', 'cui_str': 'Glioblastoma'}, {'cui': 'C0334579', 'cui_str': 'Astrocytoma, anaplastic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017638', 'cui_str': 'Glioma'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0750974', 'cui_str': 'Primary Brain Neoplasms'}]","[{'cui': 'C0076080', 'cui_str': 'temozolomide'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C1248697', 'cui_str': 'temozolomide Oral Capsule'}, {'cui': 'C4082706', 'cui_str': 'Temodal'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}]",,0.0671231,"After two cycles of treatment, there was no mortality among the 29 patients, treatment-related severe adverse events, or events that would require study discontinuation; however, one significant adverse effect (life-threatening seizures) occurred and was related to disease progression.","[{'ForeName': 'Chaoying', 'Initials': 'C', 'LastName': 'Hu', 'Affiliation': 'Department of Pharmacy Phase I Clinical Trial Center, National Clinical Research Center for Geriatric Diseases, Xuanwu Hospital of Capital Medical University, Beijing, 100053, China.'}, {'ForeName': 'Qingtang', 'Initials': 'Q', 'LastName': 'Lin', 'Affiliation': 'Department of Neurosurgery, National Clinical Research Center for Geriatric Diseases, Xuanwu Hospital of Capital Medical University, Beijing, 100053, China.'}, {'ForeName': 'Chuan', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Department of Geriatrics, National Clinical Research Center for Geriatric Diseases, Xuanwu Hospital of Capital Medical University, Beijing, 100053, China.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'TOT Biopharm Ltd, Suzhou, 215024, China.'}, {'ForeName': 'Xiaobao', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'TOT Biopharm Ltd, Suzhou, 215024, China.'}, {'ForeName': 'Xinxia', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'TOT Biopharm Ltd, Suzhou, 215024, China.'}, {'ForeName': 'Guoguang', 'Initials': 'G', 'LastName': 'Zhao', 'Affiliation': 'Department of Neurosurgery, National Clinical Research Center for Geriatric Diseases, Xuanwu Hospital of Capital Medical University, Beijing, 100053, China. ggzhao@xwhosp.org.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Pharmacy Phase I Clinical Trial Center, National Clinical Research Center for Geriatric Diseases, Xuanwu Hospital of Capital Medical University, Beijing, 100053, China. zhanglan@xwhosp.org.'}]",Cancer chemotherapy and pharmacology,['10.1007/s00280-020-04175-0']
2059,33089454,Reverse Trendelenburg position applied prior to pneumoperitoneum prevents excessive increase in optic nerve sheath diameter in laparoscopic cholecystectomy: randomized controlled trial.,"The aim of this randomized controlled trial was to determine whether applying the reverse Trendelenburg position before pneumoperitoneum has a preventive effect on increased intracranial pressure using optic nerve sheath diameter (ONSD) measurement as a noninvasive parameter. Seventy-nine patients were allocated to two groups according to whether pneumoperitoneum was applied in the supine position (group S, n = 40) or in the reverse Trendelenburg position (group RT, n = 39). The ONSD was measured at the following time points: T0: before anesthesia; T1: after endotracheal intubation; T2: after pneumoperitoneum in group S and after positioning in group RT; T3: after positioning in group S and after pneumoperitoneum in group RT; T4: 30 min after endotracheal intubation, and T5: after desufflation. The end-tidal carbon dioxide (EtCO 2 ), regional cerebral oxygen saturation (rSO 2 ), peripheral oxygen saturation (SpO 2 ), mean arterial pressure (MAP), heart rate (HR), peak inspiratory pressure (Ppeak), and dynamic compliance (Cdyn) were recorded. Background and perioperative characteristics were similar in both groups. In group S, the ONSD was higher at T2, T3, T4, and T5 than that in group RT (p < 0.001, p = 0.002, p = 0.001, and p = 0.012, respectively). In the same group, the number of patients with an ONSD above 5.8 mm was higher at T2, T3, and T4 (p < 0.001, p = 0.042, p = 0.036, respectively). The rSO2 and SpO2 were not different between the groups. The mean arterial pressure was lower in group RT at T2, and the HR was not different between the groups (p < 0.001). In group S, Ppeak was higher and Cdyn was lower at T2 (p < 0.001). The number of patients with nausea was higher in group S (p = 0.027). The present study demonstrates that applying the reverse Trendelenburg position before pneumoperitoneum prevented an increase in the ONSD in patients undergoing laparoscopic cholecystectomy.Trial registration The trial was registered prior to patient enrollment at https://register.clinicaltrials.gov (NCT04224532, Date of the registration: January 8, 2020).",2020,"In group S, Ppeak was higher and Cdyn was lower at T2 (p < 0.001).","['patients undergoing laparoscopic cholecystectomy', 'Seventy-nine patients']","['pneumoperitoneum was applied in the supine position (group S, n\u2009=\u200940) or in the reverse Trendelenburg position', 'Reverse Trendelenburg position applied prior to pneumoperitoneum']","['number of patients with nausea', 'ONSD', 'number of patients with an ONSD', 'end-tidal carbon dioxide (EtCO 2 ), regional cerebral oxygen saturation (rSO 2 ), peripheral oxygen saturation (SpO 2 ), mean arterial pressure (MAP), heart rate (HR), peak inspiratory pressure (Ppeak), and dynamic compliance (Cdyn', 'rSO2 and SpO2', 'mean arterial pressure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C3816957', 'cui_str': '70'}]","[{'cui': 'C0032320', 'cui_str': 'Pneumoperitoneum'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0038846', 'cui_str': 'Supine body position'}, {'cui': 'C0441853', 'cui_str': 'Group S'}, {'cui': 'C0277813', 'cui_str': 'Inverse Trendelenburg position'}, {'cui': 'C0332152', 'cui_str': 'Before'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0228673', 'cui_str': 'Optic nerve sheath structure'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C4273907', 'cui_str': 'Cerebral oxygen saturation'}, {'cui': 'C2317096', 'cui_str': 'Peripheral oxygen saturation'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0232021', 'cui_str': 'Peak inspiratory pressure'}, {'cui': 'C0429680', 'cui_str': 'Dynamic compliance'}]",79.0,0.0873351,"In group S, Ppeak was higher and Cdyn was lower at T2 (p < 0.001).","[{'ForeName': 'Serdar', 'Initials': 'S', 'LastName': 'Demirgan', 'Affiliation': 'Department of Anesthesiology, Bagcilar Training and Research Hospital, University of Health Sciences, Istanbul, Turkey. serdardemirgan@hotmail.com.'}, {'ForeName': 'Funda Gümüş', 'Initials': 'FG', 'LastName': 'Özcan', 'Affiliation': 'Department of Anesthesiology, Bagcilar Training and Research Hospital, University of Health Sciences, Istanbul, Turkey.'}, {'ForeName': 'Ezgi Kargı', 'Initials': 'EK', 'LastName': 'Gemici', 'Affiliation': 'Department of Anesthesiology, Bagcilar Training and Research Hospital, University of Health Sciences, Istanbul, Turkey.'}, {'ForeName': 'Hasan Cem', 'Initials': 'HC', 'LastName': 'Güneyli', 'Affiliation': 'Department of Anesthesiology, Bagcilar Training and Research Hospital, University of Health Sciences, Istanbul, Turkey.'}, {'ForeName': 'Erkan', 'Initials': 'E', 'LastName': 'Yavuz', 'Affiliation': 'Department of General Surgery, Bagcilar Training and Research Hospital, University of Health Sciences, Istanbul, Turkey.'}, {'ForeName': 'Osman Bilgin', 'Initials': 'OB', 'LastName': 'Gülçiçek', 'Affiliation': 'Department of General Surgery, Bagcilar Training and Research Hospital, University of Health Sciences, Istanbul, Turkey.'}, {'ForeName': 'Ayşin', 'Initials': 'A', 'LastName': 'Selcan', 'Affiliation': 'Department of Anesthesiology, Bagcilar Training and Research Hospital, University of Health Sciences, Istanbul, Turkey.'}]",Journal of clinical monitoring and computing,['10.1007/s10877-020-00608-6']
2060,33089472,Does Patient Race Affect Physical Therapy Treatment Recommendations?,"BACKGROUND


Racial disparities in the medical treatment of adults with arthritis are well-documented. Disparities with physical therapy treatment have yet to be thoroughly evaluated.
OBJECTIVE


To investigate the association of patient's race with physical therapy treatment recommendations for patients with arthritis.
DESIGN


Online survey.
METHODS


Physical therapists, physical therapist assistants, student physical therapists, and student physical therapist assistants within a Southern California county completed an online survey that presented a case vignette with a randomly assigned photograph of a White or Black woman. Recommendations for the plan of care included frequency of visits and number of exercises in the home exercise program (HEP), referrals to other healthcare professionals, and explicit ranking of how patient characteristics impacted the treatment planning were compared between respondents who viewed the Black or White patient.
RESULTS


Eighty-three participants completed the survey, and all participants reported that the patient was appropriate for physical therapy. Most participants (66.3%) reported that they would recommend a frequency of therapy of 2-3 times weekly. All participants recommended including a HEP. There were no statistically significant differences by patient race in recommendations for treatment frequency or referrals to other healthcare team members. HEP prescription was a median of four exercises, but participants who viewed the Black patient were more likely to recommend fewer exercises than those who viewed the White patient (p = 0.03). Explicitly, 96.1% of participants reported that race did not impact their treatment recommendations.
CONCLUSIONS


In most aspects of treatment planning, the patient's race did not impact recommendations by physical therapy professionals. The lower exercise prescription assigned to the Black patient may represent a disparity that merits further attention.",2020,There were no statistically significant differences by patient race in recommendations for treatment frequency or referrals to other healthcare team members.,"['Physical therapists, physical therapist assistants, student physical therapists, and student physical therapist assistants within a Southern California county completed an online survey that presented a case vignette with a randomly assigned photograph of a White or Black woman', 'patients with arthritis', 'adults with arthritis', 'respondents who viewed the Black or White patient']",[],[],"[{'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C1552307', 'cui_str': 'Physical Therapy Assistants'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003864', 'cui_str': 'Arthritis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0449911', 'cui_str': 'View'}]",[],[],83.0,0.0460072,There were no statistically significant differences by patient race in recommendations for treatment frequency or referrals to other healthcare team members.,"[{'ForeName': 'Alyson M', 'Initials': 'AM', 'LastName': 'Cavanaugh', 'Affiliation': 'San Diego State University/University of California San Diego, Joint Doctoral Program in Public Health, CA, San Diego, USA. alcavana@ucsd.edu.'}, {'ForeName': 'Mitchell J', 'Initials': 'MJ', 'LastName': 'Rauh', 'Affiliation': 'Doctor of Physical Therapy Program, San Diego State University, CA, San Diego, USA.'}]",Journal of racial and ethnic health disparities,['10.1007/s40615-020-00899-0']
2061,33089537,A self-management support intervention on knee functional status and health-related quality of life among middle-age women: A randomized controlled trial.,"AIM


To determine the effectiveness of a self-management support intervention on knee functional status and health-related quality of life among middle-age women with knee osteoarthritis.
DESIGN


Randomized controlled trial.
METHODS


The participants were 40 middle-aged women who had been clinically diagnosed with knee osteoarthritis for more than 3 months and randomly assigned into intervention and control groups equally. After IRB approval code 02-05-2562 was obtained, data collection was carried out from July - November 2019 at the Outpatient Department of Orthorpedics, Thasala Hospital, Thailand. The modified Thai version of the Western Ontario and McMaster University Osteoarthritis Index (WOMAC) and the Short Form Survey (SF-36) were used to measure knee functional status and health-related quality of life at baseline (T1), immediately after completing the intervention (T2) and 4 weeks after the intervention (T3). The participants in the intervention group received a self-management support program developed by the researcher based on the Individual and Family Self-Management Theory and a review of related literature plus routine care. The implementation consisted of eight sessions over 4 weeks. The control group received only routine care from the hospital. Two-way repeated measure ANOVAs were used to analyze the data.
RESULTS


The findings revealed that the participants in the intervention group had better knee functional status and HRQOL than those in the control group at follow-up. Additionally, in the intervention group, both knee functional status and HRQOL significantly improved from pre- to post-intervention and follow-up.
CONCLUSIONS


The findings indicate that this self-management support intervention is effective.
IMPACT


For women, the prevalence rate of knee OA rises dramatically post-menopause due to lower oestrogen levels. Policy makers and healthcare providers could obtain and promote this intervention as part of standard practice. This should lead to improved knee functional status and HRQOL among middle-aged women. Thai Trial Registration number: TCTR20191223003. on February 5th, 2019.",2020,The findings revealed that the participants in the intervention group had better knee functional status and HRQOL than those in the control group at follow-up.,"['middle-aged women', 'participants were 40 middle-aged women who had been clinically diagnosed with knee osteoarthritis for more than 3\xa0months', 'middle-age women', 'middle-age women with knee osteoarthritis']","['self-management support program developed by the researcher based on the Individual and Family Self-Management Theory and a review of related literature plus routine care', 'self-management support intervention']","['Western Ontario and McMaster University Osteoarthritis Index (WOMAC', 'knee functional status and health-related quality of life', 'prevalence rate of knee OA rises', 'knee functional status and HRQOL']","[{'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0026062', 'cui_str': 'Middle-age'}]","[{'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0699752', 'cui_str': 'Review of'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0023866', 'cui_str': 'Literature'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}]",,0.0614341,The findings revealed that the participants in the intervention group had better knee functional status and HRQOL than those in the control group at follow-up.,"[{'ForeName': 'Thippawan', 'Initials': 'T', 'LastName': 'Bunsanong', 'Affiliation': 'Faculty of Nursing, Walailak University, Nakhon Si Thammarat, Thailand.'}, {'ForeName': 'Nujjaree', 'Initials': 'N', 'LastName': 'Chaimongkol', 'Affiliation': 'Faculty of Nursing, Burapha University, Chon Buri, Thailand.'}]",Journal of advanced nursing,['10.1111/jan.14600']
2062,33089767,Does being accompanied make a difference in communication during breast cancer consultations? Results from a multi-centered randomized controlled trial.,"OBJECTIVES


This study is based on a multi-centered RCT conducted on breast cancer patients during their first consultation with an oncologist. The main aim was to evaluate whether the introduction of a communication tool (i.e., the Question Prompt Sheet or Question Listing), with or without a companion, impacted the number of questions asked by patients during the consultation, and subsequent psychological and relational outcomes.
METHODS


The sample consisted of 324 breast cancer patients who were randomly placed into one of the two intervention groups: Question Prompt Sheet or Question Listing. Before and after the consultation, patients completed a set of standardized instruments: Satisfaction with decisions made during the consultation (SWD), Shared Decision Making Questionnaire (SDMQ-9), Patient Enablement Instrument (PEI), Patient Health Questionnaire Depression scale (PHQ-9), General Health Questionnaire (GHQ-12).
RESULTS


The results indicate that the number of questions asked during the consultation was higher when a Question Listing was provided and when the patient was unaccompanied. Unaccompanied patients asked more questions in both groups and had significantly lower scores than accompanied on the GHQ-12 and on the PHQ-9, indicating lower clinical symptomatology.
CONCLUSIONS


Results are in contrast with previous literature, indicating that being unaccompanied help patients to interact more with the oncologist. Further studies are needed to evaluate how the presence or not of a companion really impacts breast cancer patients during their first consultation with an oncologist.
TRIAL REGISTRATION


ClinicalTrials.gov NCT01510964.",2020,"Unaccompanied patients asked more questions in both groups and had significantly lower scores than accompanied on the GHQ-12 and on the PHQ-9, indicating lower clinical symptomatology.
","['breast cancer patients during their first consultation with an oncologist', '324 breast cancer patients']",['Question Prompt Sheet or Question Listing'],"['consultation (SWD), Shared Decision Making Questionnaire (SDMQ-9), Patient Enablement Instrument (PEI), Patient Health Questionnaire Depression scale (PHQ-9), General Health Questionnaire (GHQ-12']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0259990', 'cui_str': 'Oncologists'}, {'cui': 'C4517713', 'cui_str': '324'}]","[{'cui': 'C0439643', 'cui_str': 'Sheets'}]","[{'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0451182', 'cui_str': 'General health questionnaire'}]",324.0,0.0378114,"Unaccompanied patients asked more questions in both groups and had significantly lower scores than accompanied on the GHQ-12 and on the PHQ-9, indicating lower clinical symptomatology.
","[{'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Buizza', 'Affiliation': 'Department of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Herald', 'Initials': 'H', 'LastName': 'Cela', 'Affiliation': 'Department of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Clarissa', 'Initials': 'C', 'LastName': 'Ferrari', 'Affiliation': 'Service of Statistics, IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, Brescia, Italy.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Goss', 'Affiliation': 'Department of Neurological, Biomedical and Movement Sciences, Section of Clinical Psychology, University of Verona, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Bottacini', 'Affiliation': 'Department of Neurological, Biomedical and Movement Sciences, Section of Clinical Psychology, University of Verona, Italy.'}, {'ForeName': 'Maria Angela', 'Initials': 'MA', 'LastName': 'Mazzi', 'Affiliation': 'Department of Neurological, Biomedical and Movement Sciences, Section of Clinical Psychology, University of Verona, Italy.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Del Piccolo', 'Affiliation': 'Department of Neurological, Biomedical and Movement Sciences, Section of Clinical Psychology, University of Verona, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Ghilardi', 'Affiliation': 'Department of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy.'}]",Journal of psychosocial oncology,['10.1080/07347332.2020.1829775']
2063,33089783,Sedentariness and back health in Western Cape school learners: a study protocol for pragmatic stepped wedge randomised feasibility trial.,"BACKGROUND


Despite growing evidence of deleterious health outcomes associated with sedentary behaviour, prolonged static sitting in classrooms remains ubiquitous in primary school classrooms. Sedentary behaviour is associated with the development of cardio-metabolic conditions and poor back health. Preventative strategies to reduce sedentary behaviour and its negative health effects may be required in a resource-constrained environment such as South Africa.
OBJECTIVE


Primary: To assess the feasibility of conducting a full trial to evaluate the effects of a multi-faceted intervention comprising novel multi-functional classroom furniture and a video-based curriculum versus usual care on sedentary behaviour among students aged between 10 and 11 years old in primary schools. Secondary: To assess the preliminary effects of the intervention on sedentary behaviour and postural dynamism.
METHODS


Participants: Eighty grade 5 or 6 learners, aged 10 and 11 years old, in mixed-gender, schools within the Cape Metro urban area are eligible to participate. Data to be collected at the schools. Intervention: The intervention will comprise multi-functional classroom furniture that allows for sitting and standing as well as a video-based curriculum on sedentary behaviour. Usual practice is the absence of the intervention. Setting: Western Cape Metropolitan Urban Area in South Africa. Trial design: A pilot cluster stepped-wedge trial design with classrooms as the unit of randomisation. Outcome: Primary: i) adherence to the intervention, and ii) project pragmatics. Secondary: i) sedentariness measured using activPAL3 micro sensors, and ii) postural dynamism measured using Noraxon Myomotion IMUs. Randomization: We randomized the school to the first or second start of the intervention. Blinding: This is an open-label trial and therefore not possible to blind any group. Analysis: Descriptive analysis of the feasibility and physiological outcomes will be presented. We will report the preliminary estimates of effects on sedentariness and postural dynamism using mean difference and 95% confidence interval.
RESULTS


At time of submission, two classrooms were recruited into the study. Baseline physical activity and postural dynamism data was collected from 10 participants from each class.
CONCLUSIONS


The results of this feasibility stepped-wedge cluster randomised controlled trial will be useful in informing the design on the main trial to assess whether this multifaceted intervention of multi-functional classroom furniture that allows for sitting and standing as well as a video-based curriculum versus usual care has any effects on sedentary behaviour in a low resource setting primary schools.
CLINICALTRIAL


Trial registration: PACTR201811799476016.",2020,To assess the feasibility of conducting a full trial to evaluate the effects of a multi-faceted intervention comprising novel multi-functional classroom furniture and a video-based curriculum versus usual care on sedentary behaviour among students aged between 10 and 11 years old in primary schools.,"['Western Cape school learners', 'Participants', 'Eighty grade 5 or 6 learners, aged 10 and 11 years old, in mixed-gender, schools within the Cape Metro urban area are eligible to participate', 'Setting: Western Cape Metropolitan Urban Area in South Africa', '10 participants from each class', 'students aged between 10 and 11 years old in primary schools']","['multi-faceted intervention comprising novel multi-functional classroom furniture and a video-based curriculum versus usual care', 'Intervention']","['Sedentariness and back health', 'activPAL3 micro sensors, and ii) postural dynamism measured using Noraxon Myomotion IMUs', 'Baseline physical activity and postural dynamism data', 'sedentary behaviour and postural dynamism']","[{'cui': 'C0054434', 'cui_str': 'caffeic acid phenethyl ester'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C1705232', 'cui_str': 'Common terminology criteria for adverse events grade 5'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0016858', 'cui_str': 'Furniture'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085672', 'cui_str': 'Microbiology procedure'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",2.0,0.160256,To assess the feasibility of conducting a full trial to evaluate the effects of a multi-faceted intervention comprising novel multi-functional classroom furniture and a video-based curriculum versus usual care on sedentary behaviour among students aged between 10 and 11 years old in primary schools.,"[{'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'Fisher', 'Affiliation': 'Department of Health and Rehabilitation Sciences, Stellenbosch University, Division of Physiotherapy, Faculty of Medicine and Health Sciences, Stellenbosch UniversityFrancie Zijl Avenue, P.O.Box 241, Cape town, ZA.'}, {'ForeName': 'Quinette', 'Initials': 'Q', 'LastName': 'Louw', 'Affiliation': 'Stellenbosch University, Cape town, ZA.'}, {'ForeName': 'Lehana', 'Initials': 'L', 'LastName': 'Thabane', 'Affiliation': 'McMaster University, Hamilton, CA.'}]",JMIR research protocols,['10.2196/18522']
2064,33089874,"Phase I study assessing the mass balance, pharmacokinetics, and excretion of [ 14 C]-pevonedistat, a NEDD8-activating enzyme inhibitor in patients with advanced solid tumors.","Pevonedistat (TAK-924/MLN4924) is an investigational small-molecule inhibitor of the NEDD8-activating enzyme that has demonstrated preclinical and clinical activity across solid tumors and hematological malignancies. Here we report the results of a phase I trial characterizing the mass balance, pharmacokinetics, and clearance pathways of [ 14 C]-pevonedistat in patients with advanced solid tumors (NCT03057366). In part A (n = 8), patients received a single 1-h intravenous infusion of [ 14 C]-pevonedistat 25 mg/m 2 . In part B (n = 7), patients received pevonedistat 25 or 20 mg/m 2  on days 1, 3, and 5 in combination with, respectively, docetaxel 75 mg/m 2  or carboplatin AUC5 plus paclitaxel 175 mg/m 2  on day 1 every 3 weeks. Following the single dose of [ 14 C]-pevonedistat 25 mg/m 2  in part A, there was a parallel log-linear decline in plasma and whole blood pevonedistat concentration, with systemic exposure of unchanged pevonedistat representing 41% of drug-related material (i.e., unchanged pevonedistat and its metabolites). The mean terminal half-life of pevonedistat and drug-related material in plasma was 8.4 and 15.6 h, respectively. Pevonedistat distributed preferentially in whole blood with a mean whole-blood-to-plasma ratio for pevonedistat AUC ∞  of 40.8. By 1 week post dose, the mean recovery of administered radioactivity was 94% (41% in urine and 53% in feces). The pevonedistat safety profile during both study parts was consistent with previous clinical experience, with no new safety signals observed. In part B, pevonedistat in combination with docetaxel or carboplatin plus paclitaxel was generally well tolerated. ClinicalTrials.gov identifier: NCT03057366 .",2020,Pevonedistat distributed preferentially in whole blood with a mean whole-blood-to-plasma ratio for pevonedistat AUC ∞  of 40.8.,"['patients with advanced solid tumors (NCT03057366', 'patients with advanced solid tumors']","['Pevonedistat (TAK-924/MLN4924', 'docetaxel or carboplatin plus paclitaxel', 'pevonedistat 25 or 20\xa0mg/m 2  on days 1, 3, and 5 in combination with, respectively, docetaxel 75\xa0mg/m 2  or carboplatin AUC5 plus paclitaxel']","['mean recovery of administered radioactivity', 'mean terminal half-life of pevonedistat and drug-related material in plasma', 'mass balance, pharmacokinetics, and excretion of [ 14 C]-pevonedistat', 'tolerated']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}]","[{'cui': 'C2703093', 'cui_str': 'pevonedistat'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0034553', 'cui_str': 'Radioactivity'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0018517', 'cui_str': 'Halflife'}, {'cui': 'C2703093', 'cui_str': 'pevonedistat'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0302945', 'cui_str': 'Carbon-14'}]",,0.0302712,Pevonedistat distributed preferentially in whole blood with a mean whole-blood-to-plasma ratio for pevonedistat AUC ∞  of 40.8.,"[{'ForeName': 'Xiaofei', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, 40 Landsdowne Street, Cambridge, MA, 02139, USA. xiaofei.zhou@takeda.com.'}, {'ForeName': 'Farhad', 'Initials': 'F', 'LastName': 'Sedarati', 'Affiliation': 'Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, 40 Landsdowne Street, Cambridge, MA, 02139, USA.'}, {'ForeName': 'Douglas V', 'Initials': 'DV', 'LastName': 'Faller', 'Affiliation': 'Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, 40 Landsdowne Street, Cambridge, MA, 02139, USA.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Zhao', 'Affiliation': 'Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, 40 Landsdowne Street, Cambridge, MA, 02139, USA.'}, {'ForeName': 'Hélène M', 'Initials': 'HM', 'LastName': 'Faessel', 'Affiliation': 'Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, 40 Landsdowne Street, Cambridge, MA, 02139, USA.'}, {'ForeName': 'Swapan', 'Initials': 'S', 'LastName': 'Chowdhury', 'Affiliation': 'Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, 40 Landsdowne Street, Cambridge, MA, 02139, USA.'}, {'ForeName': 'Jayaprakasam', 'Initials': 'J', 'LastName': 'Bolleddula', 'Affiliation': 'Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, 40 Landsdowne Street, Cambridge, MA, 02139, USA.'}, {'ForeName': 'Yuexian', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, 40 Landsdowne Street, Cambridge, MA, 02139, USA.'}, {'ForeName': 'Karthik', 'Initials': 'K', 'LastName': 'Venkatakrishnan', 'Affiliation': 'Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, 40 Landsdowne Street, Cambridge, MA, 02139, USA.'}, {'ForeName': 'Zsuzsanna', 'Initials': 'Z', 'LastName': 'Papai', 'Affiliation': 'Medical Center Hungarian Defense Forces, Budapest, Hungary.'}]",Investigational new drugs,['10.1007/s10637-020-01017-x']
2065,33089876,"Correction to: The effects of microdose LSD on time perception: a randomised, double-blind, placebo-controlled trial.","The manufacturer of the drug product was Onyx Scientific Limited UK, to cGMP standards.",2020,"The manufacturer of the drug product was Onyx Scientific Limited UK, to cGMP standards.",[],"['microdose LSD', 'placebo']",['time perception'],[],"[{'cui': 'C0024334', 'cui_str': 'Lysergic acid diethylamide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0040226', 'cui_str': 'Time Perception'}]",,0.307412,"The manufacturer of the drug product was Onyx Scientific Limited UK, to cGMP standards.","[{'ForeName': 'Steliana', 'Initials': 'S', 'LastName': 'Yanakieva', 'Affiliation': 'Department of Psychology, Goldsmiths, University of London, 8 Lewisham Way, New Cross, London, SE14 6NW, UK.'}, {'ForeName': 'Naya', 'Initials': 'N', 'LastName': 'Polychroni', 'Affiliation': 'Department of Psychology, Goldsmiths, University of London, 8 Lewisham Way, New Cross, London, SE14 6NW, UK.'}, {'ForeName': 'Neiloufar', 'Initials': 'N', 'LastName': 'Family', 'Affiliation': 'Eleusis Pharmaceuticals Ltd, London, UK.'}, {'ForeName': 'Luke T J', 'Initials': 'LTJ', 'LastName': 'Williams', 'Affiliation': 'Eleusis Pharmaceuticals Ltd, London, UK.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Luke', 'Affiliation': 'Department of Psychology, Social Work, & Counselling, University of Greenwich, London, UK.'}, {'ForeName': 'Devin B', 'Initials': 'DB', 'LastName': 'Terhune', 'Affiliation': 'Department of Psychology, Goldsmiths, University of London, 8 Lewisham Way, New Cross, London, SE14 6NW, UK. d.terhune@gold.ac.uk.'}]",Psychopharmacology,['10.1007/s00213-020-05682-x']
2066,33089943,The effect of 'I am Protecting my Child from the Sun' programme on parental sun protection behaviours: Randomized controlled trial.,"AIMS


This study aims to examine the effect of the 'I am Protecting my Child from the Sun' program based on the social cognitive theory, on parental use of sun protection products and sun avoidance behaviours.
DESIGN


Cluster randomized controlled trial.
METHODS


The study was conducted with three groups using a pre-test, post-test, and follow-up design. The study included 185 parents, of which 63 were in the education group, 62 were in the education + SMS group, and 60 were in the control group. The parents in the intervention group were engaged in the 'I am Protecting my Child from the Sun' program for a period of 6 weeks, while the education + SMS group, in addition to the program, also received. Primary outcomes include sunscreen use and sun avoidance behaviour and secondary outcomes were self-protection and protection of their children's behaviour. A repeated-measures ANOVA and marginal homogeneity were the main statistical tests.
RESULTS


The interventions made as part of the 'I am Protecting my Child from the Sun' program increased the following behavioural components of parents in the education group and the education + SMS group, compared with the control group: sun protection product use behaviours, sun avoidance behaviours, and behaviours related to protecting themselves and their children from the sun. There was an even higher increase in these behavioural components for those parents who also received short reminder text messages.
CONCLUSION


The 'I am Protecting my Child from the Sun' program and the receiving of short reminder messages had positive effects on the parents' behaviours related to protecting themselves and their children from the sun.
IMPACT


The 'I am Protecting my Child from the Sun' developed parents' sunscreen use self-efficacy, norms/attitudes about sunscreen use and sunscreen use expectancy behaviour, and reduced their impediments to sunscreen use behaviour. In addition, the program developed parents' sun avoidance self-efficacy, norms/attitudes about sun avoidance and sun avoidance expectancy behaviours, and reduced tanning expectancy behaviour. Receiving SMS messages following the training was effective in parental behaviours for use of sunscreen, sun avoidance, and protecting themselves and their children from the sun. Registration number: Study is registered at ClinicalTrials.gov NCT04251598.",2020,"Receiving SMS messages following the training was effective in parental behaviours for use of sunscreen, sun avoidance, and protecting themselves and their children from the sun.","['185 parents, of which 63 were in the education group, 62 were in the education\xa0+\xa0SMS group, and 60 were in the control group']","[""I am Protecting my Child from the Sun' programme"", ""I am Protecting my Child from the Sun' program"", ""I am Protecting my Child from the Sun' program increased the following behavioural components of parents in the education group and the education\xa0+\xa0SMS group, compared with the control group: sun protection product use behaviours, sun avoidance behaviours, and behaviours related to protecting themselves and their children from the sun""]","[""sunscreen use and sun avoidance behaviour and secondary outcomes were self-protection and protection of their children's behaviour"", ""parents' sun avoidance self-efficacy, norms/attitudes about sun avoidance and sun avoidance expectancy behaviours"", 'behavioural components', 'parental sun protection behaviours']","[{'cui': 'C4517617', 'cui_str': '185'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0150375', 'cui_str': 'Group education'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0795864', 'cui_str': 'Smith-Magenis syndrome'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0150375', 'cui_str': 'Group education'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0795864', 'cui_str': 'Smith-Magenis syndrome'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038817', 'cui_str': 'Sunlight'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0178494', 'cui_str': 'Avoidance behavior'}]","[{'cui': 'C0038818', 'cui_str': 'Sunscreen agent'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0038817', 'cui_str': 'Sunlight'}, {'cui': 'C0178494', 'cui_str': 'Avoidance behavior'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0237750', 'cui_str': 'Societal Norms'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0449432', 'cui_str': 'Component'}]",185.0,0.064995,"Receiving SMS messages following the training was effective in parental behaviours for use of sunscreen, sun avoidance, and protecting themselves and their children from the sun.","[{'ForeName': 'Adem', 'Initials': 'A', 'LastName': 'Sümen', 'Affiliation': 'Kumluca Faculty of Health Sciences, Department of Public Health Nursing, Akdeniz University, Antalya, Turkey.'}, {'ForeName': 'Selma', 'Initials': 'S', 'LastName': 'Öncel', 'Affiliation': 'Faculty of Nursing, Department of Public Health Nursing, Akdeniz University, Antalya, Turkey.'}]",Journal of advanced nursing,['10.1111/jan.14614']
2067,33090088,A Randomized Study Using Telepresence Robots for Behavioral Health in Interprofessional Practice and Education.,"Background:  The events of the coronavirus disease 2019 (COVID-19) pandemic forced the world to adopt telemedicine frameworks to comply with isolation and stay-at-home regulations. Telemedicine, in various forms, has been used by patients and medical professionals for quite some time, especially telepsychiatry. To examine the efficacy and role of telesimulation as a method to educate health sciences students via telepresence robots. The study recruited students from the above health science disciplines. All participants were trained to administer a contextual interview to a standardized patient (SP) for mental health concerns.  Methods:  The completion of the contextual interview observation form adult (CIOF-A), National Aeronautics and Space Administration Task Load Index, self-efficacy in patient centeredness questionnaire (SEPCQ), and communication skills attitude scale with or without a telepresence robot. All participants completed baseline metrics and were trained to conduct a contextual interview to an SP. Researchers block-randomized the participants to either the telepresence robot group (TP) or in-person (IP) group.  Results:   The study recruited  n  = 43 participants to the IP group ( n  = 21) or TP group ( n  = 22). Mean participant demographics of age were 25.3 (±1.9) years in the IP group and 24.3 (±2.1) years for the TP group. Mean and standard deviation scores with effect sizes in CIOF-A scores IP: 0.05 (±1.91) and TP: -0.45 (±1.71), Cohen's  d  = 0.28; SEPCQ-Patient Domain scores IP: 0.42 (±4.69) and TP: 0.50 (±7.18), Cohen's  d  = 0.01; change in SEPCQ-Sharing Domain scores IP: 0.53 (±5.10) and TP: 0.91 (±9.98), Cohen's  d  = 0.05. These effect sizes will inform future studies and appropriate sample sizes.   Conclusion:  These data indicate that health sciences students utilizing a telepresence robot in an SP scenario to perform a behavioral health screening felt as comfortable and competent as those health sciences students performing the same behavioral health screening in person. ClinicalTrials.gov Identifier: NCT03661372.",2020,The events of the coronavirus disease 2019 (COVID-19) pandemic forced the world to adopt telemedicine frameworks to comply with isolation and stay-at-home regulations.,"['educate health sciences students via telepresence robots', 'The study recruited  n \u2009=\u200943 participants to the IP group ( n \u2009=\u200921) or TP group ( n \u2009=\u200922', 'study recruited students from the above health science disciplines', 'Mean participant demographics of age were 25.3 (±1.9) years in the IP group and 24.3 (±2.1) years for the TP group']","['Telemedicine', 'Telepresence Robots', 'telepresence robot group (TP) or in-person (IP) group', 'contextual interview to a standardized patient (SP']","['Mean and standard deviation scores', 'contextual interview observation form adult (CIOF-A), National Aeronautics and Space Administration Task Load Index, self-efficacy in patient centeredness questionnaire (SEPCQ), and communication skills attitude scale']","[{'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0870313', 'cui_str': 'Communication skills'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.0443501,The events of the coronavirus disease 2019 (COVID-19) pandemic forced the world to adopt telemedicine frameworks to comply with isolation and stay-at-home regulations.,"[{'ForeName': 'John', 'Initials': 'J', 'LastName': 'Rosasco', 'Affiliation': 'College of Osteopathic Medicine, Pacific Northwest University of Health Sciences, Yakima, Washington, USA.'}, {'ForeName': 'Zachary', 'Initials': 'Z', 'LastName': 'Hanson', 'Affiliation': 'College of Osteopathic Medicine, Pacific Northwest University of Health Sciences, Yakima, Washington, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Kramer', 'Affiliation': 'College of Osteopathic Medicine, Pacific Northwest University of Health Sciences, Yakima, Washington, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Steele', 'Affiliation': 'Simulation Center, Pacific Northwest University of Health Sciences, Yakima, Washington, USA.'}, {'ForeName': 'Bridget', 'Initials': 'B', 'LastName': 'Beachy', 'Affiliation': 'Community Health of Central Washington, Yakima, Washington, USA.'}, {'ForeName': 'M David', 'Initials': 'MD', 'LastName': 'Gothard', 'Affiliation': 'Biostats, Inc., North Canton, Ohio, USA.'}, {'ForeName': 'Rami', 'Initials': 'R', 'LastName': 'Ahmed', 'Affiliation': 'Department of Emergency Medicine, Center of Interprofessional Education, Indiana University School of Medicine, Indianapolis, Indiana, USA.'}, {'ForeName': 'Michele L', 'Initials': 'ML', 'LastName': 'McCarroll', 'Affiliation': 'Strength-Based Solutions, LLC, Dallas, Texas, USA.'}]",Telemedicine journal and e-health : the official journal of the American Telemedicine Association,['10.1089/tmj.2020.0245']
2068,33090091,"Longitudinal trajectory analysis of antipsychotic response in patients with schizophrenia: 6-week, randomised, open-label, multicentre clinical trial.","BACKGROUND


Understanding the patterns of treatment response is critical for the treatment of patients with schizophrenia; one way to achieve this is through using a longitudinal dynamic process study design.
AIMS


This study aims to explore the response trajectory of antipsychotics and compare the treatment responses of seven different antipsychotics over 6 weeks in patients with schizoprenia (trial registration: Chinese Clinical Trials Registry Identifier: ChiCTR-TRC-10000934).
METHOD


Data were collected from a multicentre, randomised open-label clinical trial. Patients were evaluated with the Positive and Negative Syndrome Scale (PANSS) at baseline and follow-up at weeks 2, 4 and 6. Trajectory groups were classified by the method of k-means cluster modelling for longitudinal data. Trajectory analyses were also employed for the seven antipsychotic groups.
RESULTS


The early treatment response trajectories were classified into a high-trajectory group of better responders and a low-trajectory group of worse responders. The results of trajectory analysis showed differences compared with the classification method characterised by a 50% reduction in PANSS scores at week 6. A total of 349 patients were inconsistently grouped by the two methods, with a significant difference in the composition ratio of treatment response groups using these two methods (χ2 = 43.37, P < 0.001). There was no differential contribution of high- and low trajectories to different drugs (χ2 = 12.52, P = 0.051); olanzapine and risperidone, which had a larger proportion in the >50% reduction at week 6, performed better than aripiprazole, quetiapine, ziprasidone and perphenazine.
CONCLUSIONS


The trajectory analysis of treatment response to schizophrenia revealed two distinct trajectories. Comparing the treatment responses to different antipsychotics through longitudinal analysis may offer a new perspective for evaluating antipsychotics.",2020,"There was no differential contribution of high- and low trajectories to different drugs (χ2 = 12.52, P = 0.051); olanzapine and risperidone, which had a larger proportion in the >50% reduction at week 6, performed better than aripiprazole, quetiapine, ziprasidone and perphenazine.
","['patients with schizophrenia', '349 patients', 'patients with schizoprenia (trial registration']","['olanzapine', 'antipsychotics', 'aripiprazole, quetiapine, ziprasidone', 'risperidone']","['Positive and Negative Syndrome Scale (PANSS', 'composition ratio', 'PANSS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0299792', 'cui_str': 'aripiprazole'}, {'cui': 'C0123091', 'cui_str': 'quetiapine'}, {'cui': 'C0380393', 'cui_str': 'ziprasidone'}, {'cui': 'C0073393', 'cui_str': 'Risperidone'}]","[{'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",349.0,0.0729884,"There was no differential contribution of high- and low trajectories to different drugs (χ2 = 12.52, P = 0.051); olanzapine and risperidone, which had a larger proportion in the >50% reduction at week 6, performed better than aripiprazole, quetiapine, ziprasidone and perphenazine.
","[{'ForeName': 'Minhan', 'Initials': 'M', 'LastName': 'Dai', 'Affiliation': 'Mental Health Center and Psychiatric Laboratory, West China Hospital of Sichuan University, China; and West China Brain Research Center, West China Hospital of Sichuan University, China.'}, {'ForeName': 'Yulu', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Mental Health Center and Psychiatric Laboratory, West China Hospital of Sichuan University, China; and West China Brain Research Center, West China Hospital of Sichuan University, China.'}, {'ForeName': 'Yiguo', 'Initials': 'Y', 'LastName': 'Tang', 'Affiliation': 'Mental Health Center and Psychiatric Laboratory, West China Hospital of Sichuan University, China; and West China Brain Research Center, West China Hospital of Sichuan University, China.'}, {'ForeName': 'Weihua', 'Initials': 'W', 'LastName': 'Yue', 'Affiliation': 'Peking University Sixth Hospital (Institute of Mental Health), China; and National Clinical Research Center for Mental Disorders and Key Laboratory of Mental Health, Ministry of Health (Peking University), China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Yan', 'Affiliation': 'Peking University Sixth Hospital (Institute of Mental Health), China; and National Clinical Research Center for Mental Disorders and Key Laboratory of Mental Health, Ministry of Health (Peking University), China.'}, {'ForeName': 'Yamin', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Mental Health Center and Psychiatric Laboratory, West China Hospital of Sichuan University, China; West China Brain Research Center, West China Hospital of Sichuan University, China.'}, {'ForeName': 'Liwen', 'Initials': 'L', 'LastName': 'Tan', 'Affiliation': 'Second Xiangya Hospital, Central South University, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Deng', 'Affiliation': 'Mental Health Center and Psychiatric Laboratory, West China Hospital of Sichuan University, China; and West China Brain Research Center, West China Hospital of Sichuan University, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'Second Xiangya Hospital, Central South University, China.'}, {'ForeName': 'Guigang', 'Initials': 'G', 'LastName': 'Yang', 'Affiliation': 'Beijing Anding Hospital, Institute for Brain Disorders, Capital Medical University, China.'}, {'ForeName': 'Tianlan', 'Initials': 'T', 'LastName': 'Lu', 'Affiliation': 'Peking University Sixth Hospital (Institute of Mental Health), China; and National Clinical Research Center for Mental Disorders and Key Laboratory of Mental Health, Ministry of Health (Peking University), China.'}, {'ForeName': 'Lifang', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Peking University Sixth Hospital (Institute of Mental Health), China; and National Clinical Research Center for Mental Disorders and Key Laboratory of Mental Health, Ministry of Health (Peking University), China.'}, {'ForeName': 'Fude', 'Initials': 'F', 'LastName': 'Yang', 'Affiliation': 'Beijing HuiLongGuan Hospital, China.'}, {'ForeName': 'Fuquan', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': 'Wuxi Mental Health Center, Nanjing Medical University, China.'}, {'ForeName': 'Jianli', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Institute of Mental Health, Tianjin Anding Hospital, China; and Tianjin Medical University General Hospital, Tianjin Medical University, China.'}, {'ForeName': 'Keqing', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': 'Hebei Mental Health Center, China.'}, {'ForeName': 'Luxian', 'Initials': 'L', 'LastName': 'Lv', 'Affiliation': 'Second Affiliated Hospital of Xinxiang Medical University, China.'}, {'ForeName': 'Qingrong', 'Initials': 'Q', 'LastName': 'Tan', 'Affiliation': 'Department of Psychiatry, Xijing Hospital, Fourth Military Medical University, China.'}, {'ForeName': 'Hongyan', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Wuxi Mental Health Center, Nanjing Medical University, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Ma', 'Affiliation': 'Beijing Anding Hospital, Institute for Brain Disorders, Capital Medical University, China.'}, {'ForeName': 'Lingjiang', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Second Xiangya Hospital, Central South University, China.'}, {'ForeName': 'Chuanyue', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Beijing Anding Hospital, Institute for Brain Disorders, Capital Medical University, Beijing, China.'}, {'ForeName': 'Xiaohong', 'Initials': 'X', 'LastName': 'Ma', 'Affiliation': 'Mental Health Center and Psychiatric Laboratory, West China Hospital of Sichuan University, China; and West China Brain Research Center, West China Hospital of Sichuan University, China.'}, {'ForeName': 'Dai', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'Peking University Sixth Hospital (Institute of Mental Health), China; and National Clinical Research Center for Mental Disorders and Key Laboratory of Mental Health, Ministry of Health (Peking University), China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Yu', 'Affiliation': 'Department of Psychiatry, Jining Medical University, China.'}, {'ForeName': 'Liansheng', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': 'Mental Health Center and Psychiatric Laboratory, West China Hospital of Sichuan University, China; and West China Brain Research Center, West China Hospital of Sichuan University, China.'}, {'ForeName': 'Hongyan', 'Initials': 'H', 'LastName': 'Ren', 'Affiliation': 'Mental Health Center and Psychiatric Laboratory, West China Hospital of Sichuan University, China; West China Brain Research Center, West China Hospital of Sichuan University, China.'}, {'ForeName': 'Yingcheng', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Mental Health Center and Psychiatric Laboratory, West China Hospital of Sichuan University, China; and West China Brain Research Center, West China Hospital of Sichuan University, China.'}, {'ForeName': 'Xun', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'West China Brain Research Center, West China Hospital of Sichuan University, China; and Biobank, West China Hospital of Sichuan University, China.'}, {'ForeName': 'Guangya', 'Initials': 'G', 'LastName': 'Zhang', 'Affiliation': 'Suzhou Psychiatric Hospital, The Affiliated Guangji Hospital of Soochow University, China.'}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Du', 'Affiliation': 'Suzhou Psychiatric Hospital, The Affiliated Guangji Hospital of Soochow University, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Mental Health Center and Psychiatric Laboratory, West China Hospital of Sichuan University, China; and West China Brain Research Center, West China Hospital of Sichuan University, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'Mental Health Center and Psychiatric Laboratory, West China Hospital of Sichuan University, China; and West China Brain Research Center, West China Hospital of Sichuan University, China.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BJPsych open,['10.1192/bjo.2020.105']
2069,33090112,"A Telemonitoring and Hybrid Virtual Coaching Solution ""CAir"" for Patients with Chronic Obstructive Pulmonary Disease: Protocol for a Randomized Controlled Trial.","BACKGROUND


Chronic obstructive pulmonary disease (COPD) is one of the most common disorders in the world. COPD is characterized by airflow obstruction, which is not fully reversible. Patients usually experience breathing-related symptoms with periods of acute worsening and a substantial decrease in the health-related quality-of-life. Active and comprehensive disease management can slow down the progressive course of the disease and improve patients' disabilities. Technological progress and digitalization of medicine have the potential to make elaborate interventions easily accessible and applicable to a broad spectrum of patients with COPD without increasing the costs of the intervention.
OBJECTIVE


This study aims to develop a comprehensive telemonitoring and hybrid virtual coaching solution and to investigate its effects on the health-related quality of life of patients with COPD.
METHODS


A monocentric, assessor-blind, two-arm (intervention/control) randomized controlled trial will be performed. Participants randomized to the control group will receive usual care and a CAir Desk (custom-built home disease-monitoring device to telemonitor disease-relevant parameters) for 12 weeks, without feedback or scores of the telemonitoring efforts and virtual coaching. Participants randomized to the intervention group will receive a CAir Desk and a hybrid digital coaching intervention for 12 weeks. As a primary outcome, we will measure the delta in the health-related quality of life, which we will assess with the St. George Respiratory Questionnaire, from baseline to week 12 (the end of the intervention).
RESULTS


The development of the CAir Desk and virtual coach has been completed. Recruitment to the trial started in September 2020. We expect to start data collection by December 2020 and expect it to last for approximately 18 months, as we follow a multiwave approach. We expect to complete data collection by mid-2022 and plan the dissemination of the results subsequently.
CONCLUSIONS


To our knowledge, this is the first study investigating a combination of telemonitoring and hybrid virtual coaching in patients with COPD. We will investigate the effectiveness, efficacy, and usability of the proposed intervention and provide evidence to further develop app-based and chatbot-based disease monitoring and interventions in COPD.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT04373070; https://clinicaltrials.gov/ct2/show/NCT04373070.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/20412.",2020,"Technological progress and digitalization of medicine have the potential to make elaborate interventions easily accessible and applicable to a broad spectrum of patients with COPD without increasing the costs of the intervention.
","['Chronic obstructive pulmonary disease (COPD', 'patients with COPD', 'Patients with Chronic Obstructive Pulmonary Disease']","['CAir Desk and a hybrid digital coaching intervention', 'Telemonitoring and Hybrid Virtual Coaching Solution ""CAir', 'control group will receive usual care and a CAir Desk (custom-built home disease-monitoring device to telemonitor disease-relevant parameters) for 12 weeks, without feedback or scores of the telemonitoring efforts and virtual coaching', 'comprehensive telemonitoring and hybrid virtual coaching solution', 'telemonitoring and hybrid virtual coaching']","['health-related quality-of-life', 'delta in the health-related quality of life, which we will assess with the St. George Respiratory Questionnaire']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0054732', 'cui_str': 'carboxyaminoimidazole ribotide'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0162343', 'cui_str': 'Customs'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.150512,"Technological progress and digitalization of medicine have the potential to make elaborate interventions easily accessible and applicable to a broad spectrum of patients with COPD without increasing the costs of the intervention.
","[{'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Gross', 'Affiliation': 'Department of Management, Technology, and Economics, ETH Zürich, Zürich, Switzerland.'}, {'ForeName': 'Dario', 'Initials': 'D', 'LastName': 'Kohlbrenner', 'Affiliation': 'Department of Pulmonology, University Hospital of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Christian F', 'Initials': 'CF', 'LastName': 'Clarenbach', 'Affiliation': 'Department of Pulmonology, University Hospital of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Ivankay', 'Affiliation': 'Ecole Polytechnique Fédérale de Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Brunschwiler', 'Affiliation': 'IBM Research, Zürich, Rüschlikon, Switzerland.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Nordmann', 'Affiliation': 'docdok.health Ltd., Basel, Switzerland.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'V Wangenheim', 'Affiliation': 'Department of Management, Technology, and Economics, ETH Zürich, Zürich, Switzerland.'}]",JMIR research protocols,['10.2196/20412']
2070,33090208,"Dimethandrolone Undecanoate, a Novel Non-Aromatizable Androgen, Increases P1NP in Healthy Men over 28 days.","CONTEXT


Dimethandrolone undecanoate (DMAU) is being developed as a male contraceptive. Daily oral administration of DMAU, a potent androgen that is not aromatized, markedly suppresses serum testosterone (T) and estradiol (E2) in healthy men. E2 deficiency can increase bone resorption in men.
OBJECTIVE


Assess changes in bone turnover markers with DMAU administration in a 28-day study.
DESIGN


Randomized, double-blind, placebo-controlled study.
SETTING


Two academic medical centers.
PARTICIPANTS


Healthy men, 18-50 years old (n=81).
INTERVENTION


Men received 0, 100, 200 or 400 mg of oral DMAU for 28 days. Serum C-terminal telopeptide of type I collagen (CTX; bone resorption marker) and procollagen type I amino-terminal propeptide (P1NP; bone formation marker) were measured on days 1 and 28.
MAIN OUTCOME MEASURES


Changes in bone turnover markers and serum hormones over the treatment period.
RESULTS


On day 28, median serum T and E2 were markedly suppressed in all treatment groups versus placebo (p<0.0001 for both). Change (%) in serum P1NP significantly differed across treatment groups (p=0.007): serum P1NP significantly increased in the 200 mg (5%, IQR -7 to 27%) and 400 mg (22%, IQR -1 to 40%) groups relative to placebo (-8%, IQR -20 to 0%). Change (%) in serum CTX did not differ between groups (p=0.09).
CONCLUSIONS


DMAU administration for 28 days to healthy men leads to marked suppression of serum T and E2, yet increases P1NP, a serum marker of bone formation. Longer-term studies of the potent androgen DMAU are warranted to determine its impact on bone health in men.",2020,Change (%) in serum P1NP significantly differed across treatment groups (p=0.007):,"['healthy men', 'Healthy men, 18-50 years old (n=81', 'men', 'Two academic medical centers', 'Healthy Men over 28 days']","['I amino-terminal propeptide ', 'DMAU', 'Dimethandrolone Undecanoate', 'placebo', 'Dimethandrolone undecanoate (DMAU', 'oral DMAU']","['serum testosterone (T) and estradiol (E2', 'serum CTX', 'median serum T and E2', 'bone resorption', 'bone turnover markers and serum hormones', 'P1NP; bone formation marker', 'Serum C-terminal telopeptide of type I collagen (CTX; bone resorption marker) and procollagen type', 'serum P1NP']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C2974168', 'cui_str': 'dimethandrolone-undecanoate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0428413', 'cui_str': 'Serum testosterone measurement'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0010377', 'cui_str': 'Crotoxin'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0005974', 'cui_str': 'Bone resorption'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0072053', 'cui_str': 'Procollagen peptide, type 1 N-terminal'}, {'cui': 'C0029433', 'cui_str': 'Bone formation'}, {'cui': 'C1101784', 'cui_str': 'ICTP peptide'}, {'cui': 'C0033235', 'cui_str': 'Procollagen'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]",,0.323603,Change (%) in serum P1NP significantly differed across treatment groups (p=0.007):,"[{'ForeName': 'Arthi', 'Initials': 'A', 'LastName': 'Thirumalai', 'Affiliation': 'University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Yuen', 'Affiliation': 'The Lundquist Institute at Harbor UCLA Medical Center, Torrance, CA, USA.'}, {'ForeName': 'John K', 'Initials': 'JK', 'LastName': 'Amory', 'Affiliation': 'University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Andrew N', 'Initials': 'AN', 'LastName': 'Hoofnagle', 'Affiliation': 'University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Ronald S', 'Initials': 'RS', 'LastName': 'Swerdloff', 'Affiliation': 'The Lundquist Institute at Harbor UCLA Medical Center, Torrance, CA, USA.'}, {'ForeName': 'Peter Y', 'Initials': 'PY', 'LastName': 'Liu', 'Affiliation': 'The Lundquist Institute at Harbor UCLA Medical Center, Torrance, CA, USA.'}, {'ForeName': 'Jill E', 'Initials': 'JE', 'LastName': 'Long', 'Affiliation': 'NICHD, NIH, Bethesda, MD, USA.'}, {'ForeName': 'Diana L', 'Initials': 'DL', 'LastName': 'Blithe', 'Affiliation': 'NICHD, NIH, Bethesda, MD, USA.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'The Lundquist Institute at Harbor UCLA Medical Center, Torrance, CA, USA.'}, {'ForeName': 'Stephanie T', 'Initials': 'ST', 'LastName': 'Page', 'Affiliation': 'University of Washington, Seattle, WA, USA.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa761']
2071,33093056,Convalescent plasma in the management of moderate covid-19 in adults in India: open label phase II multicentre randomised controlled trial (PLACID Trial).,"OBJECTIVE


To investigate the effectiveness of using convalescent plasma to treat moderate coronavirus disease 2019 (covid-19) in adults in India.
DESIGN


Open label, parallel arm, phase II, multicentre, randomised controlled trial.
SETTING


39 public and private hospitals across India.
PARTICIPANTS


464 adults (≥18 years) admitted to hospital (screened 22 April to 14 July 2020) with confirmed moderate covid-19 (partial pressure of oxygen in arterial blood/fraction of inspired oxygen (PaO 2 /FiO 2 ) ratio between 200 mm Hg and 300 mm Hg or a respiratory rate of more than 24/min with oxygen saturation 93% or less on room air): 235 were assigned to convalescent plasma with best standard of care (intervention arm) and 229 to best standard of care only (control arm).
INTERVENTIONS


Participants in the intervention arm received two doses of 200 mL convalescent plasma, transfused 24 hours apart. The presence and levels of neutralising antibodies were not measured a priori; stored samples were assayed at the end of the study.
MAIN OUTCOME MEASURE


Composite of progression to severe disease (PaO 2 /FiO 2  <100 mm Hg) or all cause mortality at 28 days post-enrolment.
RESULTS


Progression to severe disease or all cause mortality at 28 days after enrolment occurred in 44 (19%) participants in the intervention arm and 41 (18%) in the control arm (risk difference 0.008 (95% confidence interval -0.062 to 0.078); risk ratio 1.04, 95% confidence interval 0.71 to 1.54).
CONCLUSION


Convalescent plasma was not associated with a reduction in progression to severe covid-19 or all cause mortality. This trial has high generalisability and approximates convalescent plasma use in real life settings with limited laboratory capacity. A priori measurement of neutralising antibody titres in donors and participants might further clarify the role of convalescent plasma in the management of covid-19.
TRIAL REGISTRATION


Clinical Trial Registry of India CTRI/2020/04/024775.",2020,"CONCLUSION


Convalescent plasma was not associated with a reduction in progression to severe covid-19 or all cause mortality.","['moderate covid-19 in adults in India', '464 adults (≥18 years) admitted to hospital (screened 22 April to 14 July 2020) with confirmed moderate covid-19 (partial pressure of oxygen in arterial blood/fraction of inspired oxygen (PaO 2 /FiO 2 ) ratio between 200 mm Hg and 300 mm Hg or a respiratory rate of more than 24/min with oxygen saturation 93% or less on room air): 235 were assigned to', 'moderate coronavirus disease 2019 (covid-19) in adults in India', '39 public and private hospitals across India']","['convalescent plasma with best standard of care (intervention arm) and 229 to best standard of care only (control arm', 'convalescent plasma']","['cause mortality', 'presence and levels of neutralising antibodies']","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C1822073', 'cui_str': 'PaO2'}, {'cui': 'C0428167', 'cui_str': 'Fraction of inspired oxygen'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0033173', 'cui_str': 'Private hospital'}]","[{'cui': 'C0740326', 'cui_str': 'Convalescent'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0475463', 'cui_str': 'Neutralizing antibody'}]",464.0,0.327069,"CONCLUSION


Convalescent plasma was not associated with a reduction in progression to severe covid-19 or all cause mortality.","[{'ForeName': 'Anup', 'Initials': 'A', 'LastName': 'Agarwal', 'Affiliation': 'Clinical Trial and Health Systems Research Unit, Indian Council of Medical Research, V Ramalingaswamy Bhawan, PO Box 4911, Ansari Nagar, New Delhi, 110029, India.'}, {'ForeName': 'Aparna', 'Initials': 'A', 'LastName': 'Mukherjee', 'Affiliation': 'Clinical Trial and Health Systems Research Unit, Indian Council of Medical Research, V Ramalingaswamy Bhawan, PO Box 4911, Ansari Nagar, New Delhi, 110029, India aparna.sinha.deb@icmr.gov.in.'}, {'ForeName': 'Gunjan', 'Initials': 'G', 'LastName': 'Kumar', 'Affiliation': 'Clinical Trial and Health Systems Research Unit, Indian Council of Medical Research, V Ramalingaswamy Bhawan, PO Box 4911, Ansari Nagar, New Delhi, 110029, India.'}, {'ForeName': 'Pranab', 'Initials': 'P', 'LastName': 'Chatterjee', 'Affiliation': 'Clinical Trial and Health Systems Research Unit, Indian Council of Medical Research, V Ramalingaswamy Bhawan, PO Box 4911, Ansari Nagar, New Delhi, 110029, India.'}, {'ForeName': 'Tarun', 'Initials': 'T', 'LastName': 'Bhatnagar', 'Affiliation': 'ICMR School of Public Health, Indian Council of Medical Research - National Institute of Epidemiology, Chennai, Tamil, India.'}, {'ForeName': 'Pankaj', 'Initials': 'P', 'LastName': 'Malhotra', 'Affiliation': 'Department of Internal Medicine, Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ (Clinical research ed.),['10.1136/bmj.m3939']
2072,33093133,Patients Requiring Conversion to General Anesthesia during Endovascular Therapy Have Worse Outcomes: A Post Hoc Analysis of Data from the SAGA Collaboration.,"BACKGROUND AND PURPOSE


Endovascular therapy for acute ischemic stroke is often performed with the patient under conscious sedation. Emergent conversion from conscious sedation to general anesthesia is sometimes necessary. The aim of this study was to assess the functional outcome in converted patients compared with patients who remained in conscious sedation and to identify predictors associated with the risk of conversion.
MATERIALS AND METHODS


Data from 368 patients, included in 3 trials randomizing between conscious sedation and general anesthesia before endovascular therapy (SIESTA, ANSTROKE, and GOLIATH) constituted the study cohort. Twenty-one (11%) of 185 patients randomized to conscious sedation were emergently converted to general anesthesia.
RESULTS


Absence of hyperlipidemia seemed to be the strongest predictor of conversion to general anesthesia, albeit a weak predictor (area under curve = 0.62). Sex, hypertension, diabetes, smoking status, atrial fibrillation, blood pressure, size of the infarct, and level and side of the occlusion were not significantly associated with conversion to general anesthesia. Neither age (mean age, 71.3   ± 13.8 years for conscious sedation versus 71.6  ± 12.3 years for converters,  P  = .58) nor severity of stroke (mean NIHSS score, 17 ± 4 versus 18 ± 4, respectively,  P  = .27) were significantly different between converters and those who tolerated conscious sedation. The converters had significantly worse outcome with a common odds ratio of 2.67 ( P  = .015) for a shift toward a higher mRS score compared with the patients remaining in the conscious sedation group.
CONCLUSIONS


Patients undergoing conversion had significantly worse outcome compared with patients remaining in conscious sedation. No factor was identified that predicted conversion from conscious sedation to general anesthesia.",2020,"The converters had significantly worse outcome with a common odds ratio of 2.67 ( P  = .015) for a shift toward a higher mRS score compared with the patients remaining in the conscious sedation group.
","['Data from 368 patients, included in 3 trials randomizing between conscious sedation and general anesthesia before endovascular therapy (SIESTA, ANSTROKE, and GOLIATH) constituted the study cohort', 'Twenty-one (11%) of 185 patients randomized to', 'patient under conscious sedation']",['conscious sedation'],"['Sex, hypertension, diabetes, smoking status, atrial fibrillation, blood pressure, size of the infarct, and level and side of the occlusion', 'functional outcome', 'tolerated conscious sedation', 'mRS score', 'severity of stroke']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0079159', 'cui_str': 'Conscious sedation'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C4517617', 'cui_str': '185'}]","[{'cui': 'C0079159', 'cui_str': 'Conscious sedation'}]","[{'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0079159', 'cui_str': 'Conscious sedation'}, {'cui': 'C0024487', 'cui_str': 'Magnetic resonance spectroscopy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]",185.0,0.0362995,"The converters had significantly worse outcome with a common odds ratio of 2.67 ( P  = .015) for a shift toward a higher mRS score compared with the patients remaining in the conscious sedation group.
","[{'ForeName': 'C Z', 'Initials': 'CZ', 'LastName': 'Simonsen', 'Affiliation': 'From the Department of Neurology (C.Z.S.) clasim@rm.dk.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Schönenberger', 'Affiliation': 'Department of Neurology (S.S.), Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'P L', 'Initials': 'PL', 'LastName': 'Hendén', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine (P.L.H.).'}, {'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'Yoo', 'Affiliation': 'Division of Neurointervention (A.J.Y.), Texas Stroke Institute, Dallas-Fort Worth, Texas.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Uhlmann', 'Affiliation': 'Institute of Medical Biometry and Informatics (L.U.), University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Rentzos', 'Affiliation': 'Radiology (A.R.), Sahlgrenska Academy, University of Gothenburg, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bösel', 'Affiliation': 'Department of Neurology (J.B.), Klinikum Kassel, Kassel, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Valentin', 'Affiliation': 'Department of Clinical Medicine, (J.V.), Danish Center for Clinical Health Services Research, Aalborg University and Aalborg University Hospital, North Denmark Region, Denmark.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rasmussen', 'Affiliation': 'Anesthesia (M.R.), Section of Neuroanesthesia, Aarhus University Hospital, Aarhus, Denmark.'}]",AJNR. American journal of neuroradiology,['10.3174/ajnr.A6823']
2073,33093216,Effects of metformin on disease flares in patients with systemic lupus erythematosus: post hoc analyses from two randomised trials.,"OBJECTIVE


To confirm that metformin prevents flares in patients with SLE with low disease activity, we performed a post hoc analysis combining our previous two randomised trials.
METHODS


Post hoc analyses were performed on data from the open-labelled proof-of-concept trial (n=113, ChiCTR-TRC-12002419) and placebo-controlled 'Met Lupus' trial (n=140, NCT02741960) comparing the efficacy of metformin versus placebo/nil add-on to standard therapy in patients with SLE with low disease activity (SELENA-SLEDAI ≤4). The primary endpoint was defined by the SELENA-SLEDAI Flare Index at 12-month follow-up. A subgroup analysis was performed.
RESULTS


Overall, 201 eligible patients were included, with 99 allocated to metformin group and 102 allocated to the placebo/nil group. By 12 months of follow-up, 21 patients (21.2%) flared in the metformin group, as compared with 36 (35.3%) in the placebo/nil group (p=0.027, risk ratio=0.68, 95% CI 0.46 to 0.96). Subgroup analysis showed that patients with negative anti-dsDNA antibody and normal complement at baseline, and a disease duration <5 years with concomitant use of hydroxychloroquine had a better response to metformin.
CONCLUSION


Post hoc pooled analyses suggested that metformin reduced subsequent disease flares in patients with SLE with low disease activity, especially for serologically quiescent patients.",2020,The primary endpoint was defined by the SELENA-SLEDAI Flare Index at 12-month follow-up.,"['201 eligible patients were included, with 99 allocated to', 'patients with SLE with low disease activity', 'patients with SLE with low disease activity (SELENA-SLEDAI ≤4', 'patients with systemic lupus erythematosus', 'patients with SLE']","['hydroxychloroquine', 'metformin versus placebo/nil add-on to standard therapy', 'metformin', 'placebo', 'placebo/nil group']","['disease flares', 'subsequent disease flares', 'SELENA-SLEDAI Flare Index']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0024141', 'cui_str': 'Systemic lupus erythematosus'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0451528', 'cui_str': 'Systemic lupus erythematosus disease activity index'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0442734', 'cui_str': 'Nil'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0451528', 'cui_str': 'Systemic lupus erythematosus disease activity index'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",201.0,0.230682,The primary endpoint was defined by the SELENA-SLEDAI Flare Index at 12-month follow-up.,"[{'ForeName': 'Fangfang', 'Initials': 'F', 'LastName': 'Sun', 'Affiliation': 'Rheumatology, Renji Hospital South Campus, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Shikai', 'Initials': 'S', 'LastName': 'Geng', 'Affiliation': 'Rheumatology, Renji Hospital South Campus, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Haiting', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Rheumatology, Renji Hospital South Campus, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Huijing', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Rheumatology, Renji Hospital South Campus, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Rheumatology, Renji Hospital South Campus, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Rheumatology, Renji Hospital South Campus, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'Rheumatology, Renji Hospital South Campus, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Weiguo', 'Initials': 'W', 'LastName': 'Wan', 'Affiliation': 'Rheumatology, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Liangjing', 'Initials': 'L', 'LastName': 'Lu', 'Affiliation': 'Rheumatology, Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Xiangyu', 'Initials': 'X', 'LastName': 'Teng', 'Affiliation': 'Pathology, Immunology, and Laboratory Medicine, University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Morel', 'Affiliation': 'Pathology, Immunology, and Laboratory Medicine, University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Ye', 'Affiliation': 'Rheumatology, Renji Hospital South Campus, Shanghai Jiaotong University School of Medicine, Shanghai, China ye_shuang2000@163.com.'}]",Lupus science & medicine,['10.1136/lupus-2020-000429']
2074,33093222,F2R  polymorphisms and clopidogrel efficacy and safety in patients with minor stroke or TIA.,"OBJECTIVE


To investigate the association between protease-activated receptors-1 (PAR-1) gene  F2R  polymorphisms and efficacy of clopidogrel for minor stroke or transient ischemic attack (TIA).
METHODS


Three single-nucleotide polymorphisms ( CYP2C19*2  [681G>A, rs4244285],  CYP2C19 * 3  [636G>A, rs4986893] and  F2R  [IVSn-14 A/T, rs168753] were genotyped among 2,924 patients randomized to clopidogrel plus aspirin (n = 1,461) or aspirin alone (n = 1,463). The primary efficacy outcome was new stroke (ischemic or hemorrhagic) and the safety outcome was any bleeding.
RESULTS


Overall, 859 (29.4%) were AA homozygotes, 1,479 (50.6%) were AT heterozygotes and 586 (20.0%) were TT homozygotes for  F2R  IVSn -14 polymorphisms; 1716 (58.7%) were carriers of at least one  CYP2C19  loss-of-function allele (*2 or *3). Compared with aspirin alone, patients with clopidogrel-aspirin treatment had a low risk of new stroke in patients with AT genotype (7.6% vs 11.3%; hazard ratio [HR], 0.63; 95% confidence interval [CI], 0.44-0.89) and TT genotype (5.8% vs 11.6%; HR, 0.46; 95% CI, 0.25-0.82) but not in carriers of the AA genotype (10.8% vs 11.6%; HR, 0.95; 95% CI, 0.63-1.44) ( p  = 0.03 for interaction). The association between  F2R  IVSn -14 A/T polymorphism and clopidogrel response was present regardless of the carrier status of the  CYP2C19  loss-of-function alleles. The  F2R  IVSn -14 genotypes were not associated with the risk of any bleeding for clopidogrel-aspirin treatment ( p  = 0.66 for interaction).
CONCLUSIONS


Among patients with minor ischemic stroke or TIA who were receiving clopidogrel and aspirin, those carrying  F2R  IVSn -14 T allele had a lower rate of recurrent stroke than those who were not.",2020,"genotypes were not associated with the risk of any bleeding for clopidogrel-aspirin treatment ( p  = 0.66 for interaction).
","['Three single-nucleotide polymorphisms ( CYP2C19*2  [681G>A, rs4244285],  CYP2C19', 'patients with minor stroke or TIA', 'n = 1,461) or', '2,924 patients randomized to', 'patients with minor ischemic stroke or TIA who were receiving']","['F2R  [IVSn-14 A/T, rs168753', 'clopidogrel plus aspirin', 'clopidogrel', 'aspirin alone', 'aspirin', 'clopidogrel-aspirin', 'clopidogrel and aspirin']","['rate of recurrent stroke', 'F2R  IVSn', 'low risk of new stroke', 'new stroke (ischemic or hemorrhagic) and the safety outcome was any bleeding', 'risk of any bleeding', 'F2R  polymorphisms and clopidogrel efficacy and safety']","[{'cui': 'C0752046', 'cui_str': 'Single Nucleotide Polymorphism'}, {'cui': 'C0960580', 'cui_str': 'CYP2C19 protein, human'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}]","[{'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}]","[{'cui': 'C1836785', 'cui_str': 'Recurrent stroke'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0032529', 'cui_str': 'Genetic polymorphism'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",2924.0,0.1557,"genotypes were not associated with the risk of any bleeding for clopidogrel-aspirin treatment ( p  = 0.66 for interaction).
","[{'ForeName': 'Yuesong', 'Initials': 'Y', 'LastName': 'Pan', 'Affiliation': ""From the Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, ChinaChina National Clinical Research Center for Neurological Diseases, Beijing, ChinaDepartment of Neurology, Duke University Medical Center, Durham, NC, USADell Medical School, University of Texas at Austin, Austin, USAAssistance Publique-Hôpitaux de Paris, Department of Clinical Pharmacology and Clinical Research Platform of East of Paris (URCEST-CRC-CRB), Hopital Saint Antoine (APHP.SU), Paris, FranceSorbonne Université, Paris, FranceFACT (French Alliance for Cardiovascular clinical Trials), Paris, FranceDepartment of Neurology, Barrow Neurological Institute, St. Joseph's Hospital and Medical Center, Phoenix, USA.""}, {'ForeName': 'Runqi', 'Initials': 'R', 'LastName': 'Wangqin', 'Affiliation': ""From the Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, ChinaChina National Clinical Research Center for Neurological Diseases, Beijing, ChinaDepartment of Neurology, Duke University Medical Center, Durham, NC, USADell Medical School, University of Texas at Austin, Austin, USAAssistance Publique-Hôpitaux de Paris, Department of Clinical Pharmacology and Clinical Research Platform of East of Paris (URCEST-CRC-CRB), Hopital Saint Antoine (APHP.SU), Paris, FranceSorbonne Université, Paris, FranceFACT (French Alliance for Cardiovascular clinical Trials), Paris, FranceDepartment of Neurology, Barrow Neurological Institute, St. Joseph's Hospital and Medical Center, Phoenix, USA.""}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': ""From the Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, ChinaChina National Clinical Research Center for Neurological Diseases, Beijing, ChinaDepartment of Neurology, Duke University Medical Center, Durham, NC, USADell Medical School, University of Texas at Austin, Austin, USAAssistance Publique-Hôpitaux de Paris, Department of Clinical Pharmacology and Clinical Research Platform of East of Paris (URCEST-CRC-CRB), Hopital Saint Antoine (APHP.SU), Paris, FranceSorbonne Université, Paris, FranceFACT (French Alliance for Cardiovascular clinical Trials), Paris, FranceDepartment of Neurology, Barrow Neurological Institute, St. Joseph's Hospital and Medical Center, Phoenix, USA.""}, {'ForeName': 'Yilong', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""From the Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, ChinaChina National Clinical Research Center for Neurological Diseases, Beijing, ChinaDepartment of Neurology, Duke University Medical Center, Durham, NC, USADell Medical School, University of Texas at Austin, Austin, USAAssistance Publique-Hôpitaux de Paris, Department of Clinical Pharmacology and Clinical Research Platform of East of Paris (URCEST-CRC-CRB), Hopital Saint Antoine (APHP.SU), Paris, FranceSorbonne Université, Paris, FranceFACT (French Alliance for Cardiovascular clinical Trials), Paris, FranceDepartment of Neurology, Barrow Neurological Institute, St. Joseph's Hospital and Medical Center, Phoenix, USA. yongjunwang@ncrcnd.org.cn.""}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Meng', 'Affiliation': ""From the Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, ChinaChina National Clinical Research Center for Neurological Diseases, Beijing, ChinaDepartment of Neurology, Duke University Medical Center, Durham, NC, USADell Medical School, University of Texas at Austin, Austin, USAAssistance Publique-Hôpitaux de Paris, Department of Clinical Pharmacology and Clinical Research Platform of East of Paris (URCEST-CRC-CRB), Hopital Saint Antoine (APHP.SU), Paris, FranceSorbonne Université, Paris, FranceFACT (French Alliance for Cardiovascular clinical Trials), Paris, FranceDepartment of Neurology, Barrow Neurological Institute, St. Joseph's Hospital and Medical Center, Phoenix, USA.""}, {'ForeName': 'S Claiborne', 'Initials': 'SC', 'LastName': 'Johnston', 'Affiliation': ""From the Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, ChinaChina National Clinical Research Center for Neurological Diseases, Beijing, ChinaDepartment of Neurology, Duke University Medical Center, Durham, NC, USADell Medical School, University of Texas at Austin, Austin, USAAssistance Publique-Hôpitaux de Paris, Department of Clinical Pharmacology and Clinical Research Platform of East of Paris (URCEST-CRC-CRB), Hopital Saint Antoine (APHP.SU), Paris, FranceSorbonne Université, Paris, FranceFACT (French Alliance for Cardiovascular clinical Trials), Paris, FranceDepartment of Neurology, Barrow Neurological Institute, St. Joseph's Hospital and Medical Center, Phoenix, USA.""}, {'ForeName': 'Tabassome', 'Initials': 'T', 'LastName': 'Simon', 'Affiliation': ""From the Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, ChinaChina National Clinical Research Center for Neurological Diseases, Beijing, ChinaDepartment of Neurology, Duke University Medical Center, Durham, NC, USADell Medical School, University of Texas at Austin, Austin, USAAssistance Publique-Hôpitaux de Paris, Department of Clinical Pharmacology and Clinical Research Platform of East of Paris (URCEST-CRC-CRB), Hopital Saint Antoine (APHP.SU), Paris, FranceSorbonne Université, Paris, FranceFACT (French Alliance for Cardiovascular clinical Trials), Paris, FranceDepartment of Neurology, Barrow Neurological Institute, St. Joseph's Hospital and Medical Center, Phoenix, USA.""}, {'ForeName': 'Jinxi', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': ""From the Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, ChinaChina National Clinical Research Center for Neurological Diseases, Beijing, ChinaDepartment of Neurology, Duke University Medical Center, Durham, NC, USADell Medical School, University of Texas at Austin, Austin, USAAssistance Publique-Hôpitaux de Paris, Department of Clinical Pharmacology and Clinical Research Platform of East of Paris (URCEST-CRC-CRB), Hopital Saint Antoine (APHP.SU), Paris, FranceSorbonne Université, Paris, FranceFACT (French Alliance for Cardiovascular clinical Trials), Paris, FranceDepartment of Neurology, Barrow Neurological Institute, St. Joseph's Hospital and Medical Center, Phoenix, USA.""}, {'ForeName': 'Xingquan', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': ""From the Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, ChinaChina National Clinical Research Center for Neurological Diseases, Beijing, ChinaDepartment of Neurology, Duke University Medical Center, Durham, NC, USADell Medical School, University of Texas at Austin, Austin, USAAssistance Publique-Hôpitaux de Paris, Department of Clinical Pharmacology and Clinical Research Platform of East of Paris (URCEST-CRC-CRB), Hopital Saint Antoine (APHP.SU), Paris, FranceSorbonne Université, Paris, FranceFACT (French Alliance for Cardiovascular clinical Trials), Paris, FranceDepartment of Neurology, Barrow Neurological Institute, St. Joseph's Hospital and Medical Center, Phoenix, USA.""}, {'ForeName': 'Liping', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': ""From the Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, ChinaChina National Clinical Research Center for Neurological Diseases, Beijing, ChinaDepartment of Neurology, Duke University Medical Center, Durham, NC, USADell Medical School, University of Texas at Austin, Austin, USAAssistance Publique-Hôpitaux de Paris, Department of Clinical Pharmacology and Clinical Research Platform of East of Paris (URCEST-CRC-CRB), Hopital Saint Antoine (APHP.SU), Paris, FranceSorbonne Université, Paris, FranceFACT (French Alliance for Cardiovascular clinical Trials), Paris, FranceDepartment of Neurology, Barrow Neurological Institute, St. Joseph's Hospital and Medical Center, Phoenix, USA.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': ""From the Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, ChinaChina National Clinical Research Center for Neurological Diseases, Beijing, ChinaDepartment of Neurology, Duke University Medical Center, Durham, NC, USADell Medical School, University of Texas at Austin, Austin, USAAssistance Publique-Hôpitaux de Paris, Department of Clinical Pharmacology and Clinical Research Platform of East of Paris (URCEST-CRC-CRB), Hopital Saint Antoine (APHP.SU), Paris, FranceSorbonne Université, Paris, FranceFACT (French Alliance for Cardiovascular clinical Trials), Paris, FranceDepartment of Neurology, Barrow Neurological Institute, St. Joseph's Hospital and Medical Center, Phoenix, USA. yongjunwang@ncrcnd.org.cn.""}, {'ForeName': 'Yongjun', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""From the Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, ChinaChina National Clinical Research Center for Neurological Diseases, Beijing, ChinaDepartment of Neurology, Duke University Medical Center, Durham, NC, USADell Medical School, University of Texas at Austin, Austin, USAAssistance Publique-Hôpitaux de Paris, Department of Clinical Pharmacology and Clinical Research Platform of East of Paris (URCEST-CRC-CRB), Hopital Saint Antoine (APHP.SU), Paris, FranceSorbonne Université, Paris, FranceFACT (French Alliance for Cardiovascular clinical Trials), Paris, FranceDepartment of Neurology, Barrow Neurological Institute, St. Joseph's Hospital and Medical Center, Phoenix, USA. yongjunwang@ncrcnd.org.cn.""}]",Neurology,['10.1212/WNL.0000000000011078']
2075,33093910,Effectiveness of transcutaneous electrical stimulation combined with artificial tears for the treatment of dry eye: A randomized controlled trial.,"There is currently no available cure or universally effective treatment for dry eye (DE). The aim of the present study was to investigate the clinical efficacy of transcutaneous electrical stimulation (TES) combined with artificial tears in treating DE. Patients diagnosed with DE were referred for therapy with TES combined with sodium hyaluronate (SH)-containing artificial tears. A total of 52 patients (104 eyes) with DE were enrolled in this randomized controlled trial. The patients were randomized 1:1 to the TES + SH or SH group. The patients in the TES + SH group were treated with 20 sessions (5 sessions per week for 4 weeks), and each session lasted for 20 min. The treatment was continued for 4 weeks in all cases. The Ocular Surface Disease Index (OSDI), tear film breakup time (BUT), Schirmer's I test and corneal fluorescein scores were used to assess treatment efficacy. A total of 90 eyes of 45 patients completed all aspects of the study: 22 patients (44 eyes) in the TES + SH group and 23 patients (46 eyes) in the SH group. There was no statistically significant difference in sex, age or course between the two groups. The mean OSDI scores, BUT, Schirmer's I test and corneal fluorescein scores exhibited a significant improvement in the TES + SH group compared with the SH group after treatment. No serious adverse events were recorded during TES treatment. In conclusion, TES combined with artificial tears appeared to be an effective treatment for DE. Therefore, TES may represent a new therapeutic option with promising potential applications.",2020,"The mean OSDI scores, BUT, Schirmer's I test and corneal fluorescein scores exhibited a significant improvement in the TES + SH group compared with the SH group after treatment.","['52 patients (104 eyes) with DE', 'A total of 90 eyes of 45 patients completed all aspects of the study: 22 patients (44 eyes) in the', 'dry eye', 'group and 23 patients (46 eyes) in the SH group', 'Patients diagnosed with DE were referred for therapy with TES combined with sodium hyaluronate (SH)-containing artificial tears']","['TES + SH', 'TES', 'SH', 'transcutaneous electrical stimulation combined with artificial tears', 'transcutaneous electrical stimulation (TES) combined with artificial tears', 'TES + SH or SH']","[""mean OSDI scores, BUT, Schirmer's I test and corneal fluorescein scores"", ""Ocular Surface Disease Index (OSDI), tear film breakup time (BUT), Schirmer's I test and corneal fluorescein scores"", 'serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0087000', 'cui_str': 'Hyaluronate sodium'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0040654', 'cui_str': 'Percutaneous electrical nerve stimulation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C2608262', 'cui_str': 'Artificial Tears'}]","[{'cui': 'C0040654', 'cui_str': 'Percutaneous electrical nerve stimulation'}, {'cui': 'C0087000', 'cui_str': 'Hyaluronate sodium'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C2608262', 'cui_str': 'Artificial Tears'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1557335', 'cui_str': 'Ocular surface disease'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1301514', 'cui_str': 'Schirmer I test'}, {'cui': 'C0016314', 'cui_str': 'Fluoresceins'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C1704608', 'cui_str': 'Film'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",52.0,0.023758,"The mean OSDI scores, BUT, Schirmer's I test and corneal fluorescein scores exhibited a significant improvement in the TES + SH group compared with the SH group after treatment.","[{'ForeName': 'Ming-Ming', 'Initials': 'MM', 'LastName': 'Cai', 'Affiliation': ""Department of Ophthalmology, The Ninth People's Hospital of Chongqing, Chongqing 400700, P.R. China.""}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ""Department of Urology, The Ninth People's Hospital of Chongqing, Chongqing 400700, P.R. China.""}]",Experimental and therapeutic medicine,['10.3892/etm.2020.9305']
2076,33093965,Modulation of Interleukin-8 Production by Vitamin D Supplementation in Indonesian Patients with Diabetic Polyneuropathy: A Randomized Clinical Trial.,"Objectives


We sought to assess the modulation of interleukin-8 (IL-8) production by vitamin D supplementation in Indonesian patients with diabetic polyneuropathy (DPN).
Methods


We conducted a cohort prospective, randomized, placebo-controlled, double-blind trial. This study was approved by the Local Ethical Committee and conducted from July 2018 to February 2019. We recruited 50 subjects with type 2 diabetes mellitus attending Haji Adam Malik General Hospital Medan, and divided them into two groups. The groups were treated for 10 weeks, either with placebo or vitamin D (D 3 ) supplementation of 50 000 IU/week. They were evaluated by routine nerve conduction study (NCS) in the upper and lower limbs, and their serum vitamin 25-hydroxyvitamin D (25(OH)D) and IL-8 levels before and 10 weeks after placebo or vitamin D supplementation were measured. The role of IL-8 and vitamin D supplementation on the NCS was analyzed using linear regression.
Results


There was a significant difference between the mean vitamin 25(OH)D ( p =  0.001) and IL-8 levels ( p =  0.002) before and after vitamin D supplementation. There was no significant correlation between changes in vitamin 25(OH)D and IL-8 levels ( p =  0.743). There was significant role of IL-8 on amplitude of the sensory sural nerve ( p =  0.047; B = -0.009) and the nerve conduction velocity (NCV) of the motor tibial nerve ( p =  0.007; B = -0.027). There was a significant role of vitamin D supplementation on NCSs.
Conclusions


Higher IL-8 levels were correlated with poorer amplitude of the sensory sural nerve and the NCV of motor tibial nerves. Lower vitamin 25(OH)D levels were correlated with poorer distal latencies, amplitudes, and NCVs. There was no significant correlation between vitamin 25(OH)D and IL-8 levels. Thus, no sufficient evidence that vitamin D supplementation modulates IL-8 in Indonesian patients with DPN. Vitamin D 3  improved NCSs in diabetic patients.",2020,There was significant role of IL-8 on amplitude of the sensory sural nerve ( p =  0.047; B = -0.009) and the nerve conduction velocity (NCV) of the motor tibial nerve ( p =  0.007;,"['Indonesian Patients with Diabetic Polyneuropathy', 'Indonesian patients with diabetic polyneuropathy (DPN', 'Indonesian patients with DPN', 'diabetic patients', 'July 2018 to February 2019', '50 subjects with type 2 diabetes mellitus attending Haji Adam Malik General Hospital Medan, and divided them into two groups']","['vitamin D supplementation', 'Vitamin D', 'placebo or vitamin D', 'placebo', 'placebo or vitamin D supplementation', 'Vitamin D Supplementation', 'IL-8 and vitamin D supplementation']","['IL-8 levels', 'IL-8 on amplitude of the sensory sural nerve', 'serum vitamin 25-hydroxyvitamin D (25(OH)D) and IL-8 levels', 'mean vitamin 25(OH)D', 'Lower vitamin 25(OH)D levels', 'modulation of interleukin-8 (IL-8) production', 'distal latencies, amplitudes, and NCVs', 'vitamin 25(OH)D and IL-8 levels', 'nerve conduction velocity (NCV) of the motor tibial nerve']","[{'cui': 'C0021248', 'cui_str': 'Indonesian language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0271680', 'cui_str': 'Diabetic polyneuropathy'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C1529905', 'cui_str': '(123I)ADAM'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}]","[{'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0038879', 'cui_str': 'Structure of sural nerve'}, {'cui': 'C0428581', 'cui_str': 'Serum vitamin A measurement'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0042890', 'cui_str': 'Vitamin'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0429381', 'cui_str': 'Nerve conduction velocity'}, {'cui': 'C0040186', 'cui_str': 'Structure of tibial nerve'}]",50.0,0.271029,There was significant role of IL-8 on amplitude of the sensory sural nerve ( p =  0.047; B = -0.009) and the nerve conduction velocity (NCV) of the motor tibial nerve ( p =  0.007;,"[{'ForeName': 'Aida', 'Initials': 'A', 'LastName': 'Fitri', 'Affiliation': 'Department of Neurology, Faculty of Medicine, Universitas Sumatera Utara, Medan, Indonesia.'}, {'ForeName': 'Hasan', 'Initials': 'H', 'LastName': 'Sjahrir', 'Affiliation': 'Department of Neurology, Faculty of Medicine, Universitas Sumatera Utara, Medan, Indonesia.'}, {'ForeName': 'Adang', 'Initials': 'A', 'LastName': 'Bachtiar', 'Affiliation': 'Faculty of Public Health, Universitas Indonesia, Depok, Indonesia.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Ichwan', 'Affiliation': 'Department of Pharmacology and Therapeutic, Faculty of Medicine, Universitas Sumatera Utara, Medan, Indonesia.'}]",Oman medical journal,['10.5001/omj.2020.110']
2077,33094004,Effectiveness of Progestogens as Maintenance Tocolysis and Urogenital Cultures: Secondary Analysis of the PROTECT Trial.,"Background   In a recently published multicenter randomized controlled trial, we demonstrated that progestogens are not effective as maintenance tocolysis.  Objective   This study was aimed to evaluate if previous finding may be affected by positive urine culture and/or vaginal swab.  Study Design   We performed a secondary analysis of the PROTECT trial (NCT01178788). Women with singleton pregnancy between 22 and 31  6/7  weeks' gestation, admitted for threatened preterm labor were considered. At admission, we collected urine culture and vaginal swabs. At discharge, women with a cervical length ≤25 mm were randomized to vaginal progesterone or 17α-hydroxyprogesterone caproate or observation group. We used Chi-square statistics, considering 97.5% CI (confidence interval) and  p  -value less than 0.025 for significance.  Results   Urine culture and vaginal swabs were collected in 232 out of 235 patients included in the primary analysis. Overall, 31 out of 232 women (13.4%) had positive urine culture and 60 out of 232 (25.9%) had positive vaginal swab. In women with negative urine culture, a higher rate of preterm birth was found in vaginal progesterone group (27/69, 39.7%) respect with controls (14/68, 20.6%; relative risk [RR] = 1.90; 97.5% CI: 1.01-3.57;  p   = 0.018).  Conclusion   Among women with negative urine culture, the rate of preterm birth <37 weeks' gestation was significantly increased in those receiving vaginal progesterone, reinforcing our previous findings in symptomatic women.",2020,"In women with negative urine culture, a higher rate of preterm birth was found in vaginal progesterone group (27/69, 39.7%) respect with controls (14/68, 20.6%; relative risk [RR] = 1.90; 97.5% CI: 1.01-3.57;  p   = 0.018).  ","[""Women with singleton pregnancy between 22 and 31  6/7  weeks' gestation, admitted for threatened preterm labor"", 'women with a cervical length ≤25\u2009mm', '232 out of 235 patients included in the primary analysis']","['vaginal progesterone or 17α-hydroxyprogesterone caproate or observation group', 'Progestogens']","['Urine culture and vaginal swabs', 'rate of preterm birth', ""rate of preterm birth <37 weeks' gestation"", 'positive urine culture', 'positive vaginal swab']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0022876', 'cui_str': 'Premature labor'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0044971', 'cui_str': 'Hydroxyprogesterone caproate'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0033306', 'cui_str': 'Progestational hormone'}]","[{'cui': 'C0430404', 'cui_str': 'Urine culture'}, {'cui': 'C0444207', 'cui_str': 'Vaginal swab'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C1446409', 'cui_str': 'Positive'}]",235.0,0.488839,"In women with negative urine culture, a higher rate of preterm birth was found in vaginal progesterone group (27/69, 39.7%) respect with controls (14/68, 20.6%; relative risk [RR] = 1.90; 97.5% CI: 1.01-3.57;  p   = 0.018).  ","[{'ForeName': 'Lucrezia', 'Initials': 'L', 'LastName': 'Pignatti', 'Affiliation': 'Department of Mother Infant, Obstetrics and Gynecology Unit, University of Modena and Reggio Emilia, Modena, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': ""D'Amico"", 'Affiliation': 'Department of Diagnostic, Clinical and Public Health Medicine, Statistics Unit, University of Modena and Reggio Emilia, Modena, Italy.'}, {'ForeName': 'Patrizia', 'Initials': 'P', 'LastName': 'Vergani', 'Affiliation': 'Department of Medicine and Surgery, Obstetrics Gynecology Branch, University of Milano-Bicocca Health Science, Milano, Lombardia, Italy.'}, {'ForeName': 'Mariarosaria', 'Initials': 'M', 'LastName': 'Di Tommaso', 'Affiliation': 'Department of Health Science, Obstetrics and Gynecology Branch, University of Florence, Florence, Italy.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Acaia', 'Affiliation': 'Obstetrics and Gynecology Unit, Istituto di Ricovero e Cura a Carattere Scientifico Policlinico, Milan, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Benedetto', 'Affiliation': 'Department of Surgical Sciences, Gynaecology and Obstetrics, University of Turin, Turin, Piemonte, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Facchinetti', 'Affiliation': 'Department of Mother Infant, Obstetrics and Gynecology Unit, University of Modena and Reggio Emilia, Modena, Italy.'}]",AJP reports,['10.1055/s-0040-1713788']
2078,33094142,A controlled trial of Gomco versus Plastibell for neonatal circumcisions in Saudi Arabia.,"Background


Gomco or Plastibell devices are the most widely used method for circumcision. The present work was aimed to assess the incidence of complications in infants of ages up to six months in two used methods.
Methods


It was a prospective randomized study conducted at a pediatric surgery clinic in 3 hospitals in Jeddah, Saudi Arabia. Eight hundred and five children, their ages were less than 6 months were enrolled for the present work. Children were randomized into two groups: Groups P and G using Plastibell and Gomco Circumcision methods, respectively. Statistical analysis of data was performed by using SPSS Version 17. Chi-square test and independent sample  t -test was applied to compare both qualitative and quantitative variables, respectively.  P -value was considered as significant difference at <0.05.
Results


Seven hundred eighty three children were were enrolled in this investigation. Plastibell method was concomitant with low volume of bleeding in comparison with Gomco method ( P     < 0.001). Incidence of complications including infection, penile edema, proximal migration and redundant skin was higher in Plastibell device method ( P <0.05).
Conclusion


Gomco circumcision is the safer method and is accompanied with lowest rate of complication.",2020,"Incidence of complications including infection, penile edema, proximal migration and redundant skin was higher in Plastibell device method ( P <0.05).
","['Saudi Arabia', 'pediatric surgery clinic in 3 hospitals in Jeddah, Saudi Arabia', 'Eight hundred and five children, their ages were less than 6 months were enrolled for the present work', 'Seven hundred eighty three children', 'infants of ages up to six months in two used methods']",['Gomco versus Plastibell'],"['Incidence of complications including infection, penile edema, proximal migration and redundant skin', 'incidence of complications']","[{'cui': 'C0036243', 'cui_str': 'Saudi Arabia'}, {'cui': 'C3839137', 'cui_str': 'Pediatric surgery clinic'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C4517862', 'cui_str': '700'}, {'cui': 'C4517888', 'cui_str': '83'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0574086', 'cui_str': 'Plastibell'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0156308', 'cui_str': 'Edema of penis'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0237731', 'cui_str': 'Human Migration'}, {'cui': 'C0581342', 'cui_str': 'Redundant skin'}]",805.0,0.0441137,"Incidence of complications including infection, penile edema, proximal migration and redundant skin was higher in Plastibell device method ( P <0.05).
","[{'ForeName': 'Osama A', 'Initials': 'OA', 'LastName': 'Bawazir', 'Affiliation': 'Department of Surgery Faculty of Medicine in Umm Al-Qura University Faculty of Medicine, KSA, P.O.box 715, Makkah, 21955, Saudi Arabia.'}]",International journal of pediatrics & adolescent medicine,['10.1016/j.ijpam.2019.03.002']
2079,33094406,Does a pretreatment with a dentine hypersensitivity mouth-rinse compensate the pain caused by professional mechanical plaque removal? A single-blind randomized controlled clinical trial.,"OBJECTIVES


Pain is affecting acceptance of supportive periodontal therapy and primary periodontitis prevention. Our objective was to evaluate the efficacy of a 1-week pre-treatment use of dentinal-hypersensitivity-reducing mouth-rinses (DHM) in periodontal maintenance (SPT) or dental prophylaxis patients.
MATERIAL AND METHODS


One hundred fifty-five participants attending for professional mechanical plaque removal (PMPR) were randomly assigned to use a mouth-rinse twice daily for 1 week prior to their next PMPR. Rinses were containing either potassium oxalate (n = 52), arginine (n = 52), or herbal extracts (n = 51). At baseline and reassessment, procedural pain was assessed by visual analogue scale (VAS) and verbal rating scale (VRS). Self-reported efficacy was documented.
RESULTS


No inter-group differences were estimated between both test groups and the control for baseline and reassessment means (VAS, VRS). In the SPT group, VAS reduction and self-reported efficacy were found (p < 0.05).
CONCLUSION


The 1-week use of DHM failed to show a predictable effect on discomfort during PMPR overall. Around 20% of the patients showed a quantifiable benefit from both test mouth-rinses, whereas more than 50% reported a subjective pain reduction. Focusing patients undergoing supportive periodontal therapy, quantifiable effects were found for both test groups. From a patient's point of view, DHM might be a suitable adjunct to enhance procedural comfort, especially in patients with a history of periodontitis.
CLINICAL RELEVANCE


The 1-week use of the dentinal-hypersensitivity-reducing mouth-rinses prior to professional-mechanical-plaque-removal showed to be a suitable adjunct to enhance procedural comfort during instrumentation, especially in patients undergoing supportive periodontal therapy. Registration number: DRKS00010811.",2020,"No inter-group differences were estimated between both test groups and the control for baseline and reassessment means (VAS, VRS).","['patients undergoing supportive periodontal therapy', 'patients with a history of periodontitis', 'periodontal maintenance (SPT) or dental prophylaxis patients', 'One hundred fifty-five participants attending for professional mechanical plaque removal (PMPR']","['dentinal-hypersensitivity-reducing mouth-rinses prior to professional-mechanical-plaque-removal', 'dentinal-hypersensitivity-reducing mouth-rinses (DHM', 'arginine', 'herbal extracts', 'potassium oxalate', 'DHM', 'supportive periodontal therapy']","['procedural pain', 'subjective pain reduction', 'visual analogue scale (VAS) and verbal rating scale (VRS', 'VAS reduction and self-reported efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0011393', 'cui_str': 'Prophylaxis, Dental'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]","[{'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0026647', 'cui_str': 'Oromucosal solution for gargle'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C0376667', 'cui_str': 'Herbals'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0032837', 'cui_str': 'Potassium oxalate'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C1619712', 'cui_str': 'Procedural pain'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0458261', 'cui_str': 'Verbal rating scale'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",155.0,0.0279804,"No inter-group differences were estimated between both test groups and the control for baseline and reassessment means (VAS, VRS).","[{'ForeName': 'Sonja H M', 'Initials': 'SHM', 'LastName': 'Derman', 'Affiliation': 'Department of Operative Dentistry and Periodontology, University of Cologne, Kerpener Str. 32, 50931, Cologne, Germany. sonja.derman@uk-koeln.de.'}, {'ForeName': 'Eva-Maria', 'Initials': 'EM', 'LastName': 'Lantwin', 'Affiliation': 'Department of Operative Dentistry and Periodontology, University of Cologne, Kerpener Str. 32, 50931, Cologne, Germany.'}, {'ForeName': 'Anna Greta', 'Initials': 'AG', 'LastName': 'Barbe', 'Affiliation': 'Department of Operative Dentistry and Periodontology, University of Cologne, Kerpener Str. 32, 50931, Cologne, Germany.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Noack', 'Affiliation': 'Department of Operative Dentistry and Periodontology, University of Cologne, Kerpener Str. 32, 50931, Cologne, Germany.'}]",Clinical oral investigations,['10.1007/s00784-020-03643-4']
2080,33094438,Open-Label Placebo Treatment: Outcome Expectations and General Acceptance in the Lay Population.,"BACKGROUND


Most physicians sometimes apply therapies without specific active ingredients. Although patients seem to judge such placebo treatments as acceptable under certain circumstances, deception is still an ethical problem. Open-label placebos (OLPs) might be a promising approach to solve this dilemma. This study compared general acceptance and outcome expectations of OLPs and deceptive placebos (DPs).
METHODS


In an experimental online study, 814 participants read a case vignette of a person with insomnia receiving a pill. The participants were then randomly allocated into two groups, where the second part of the vignette described the pill as either a deceptive placebo (DP group) or as an open-label placebo (OLP group). The Credibility/Expectancy Questionnaire (CEQ) assessed outcome expectations after the first (pre-assessment) and the second (post-assessment) parts of the vignette. Treatment acceptance was measured at post-assessment. Data from 798 participants were analyzed by a mixed multivariate analysis of variance (MANOVA), t-tests, and post-hoc mediation analyses.
RESULTS


The MANOVA revealed a significant group main effect and a significant time × group interaction effect. At post-assessment, outcome expectations were higher in the DP group than in the OLP group. Acceptance of the placebo treatment was also higher in the DP group than in the OLP group. Mediation analyses confirmed that higher acceptance in the DP group was mediated by higher expectations.
CONCLUSIONS


When laypersons read about placebo treatment, their outcome expectations toward DPs were higher than toward OLPs. Surprisingly, the application of DPs was rated as more acceptable than OLPs. This result might be explained by indirect effects of treatment expectations.",2020,"At post-assessment, outcome expectations were higher in the DP group than in the OLP group.","['814 participants read a case vignette of a person with insomnia receiving a pill', '798 participants']","['deceptive placebo (DP group) or as an open-label placebo (OLP group', 'OLPs and deceptive placebos (DPs', 'Open-label placebos (OLPs', 'Open-Label Placebo Treatment', 'placebo', 'OLP']","['Treatment acceptance', 'Credibility/Expectancy Questionnaire (CEQ) assessed outcome expectations']","[{'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",814.0,0.0963888,"At post-assessment, outcome expectations were higher in the DP group than in the OLP group.","[{'ForeName': 'Julia W', 'Initials': 'JW', 'LastName': 'Haas', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Philipps-University of Marburg, Marburg, Germany. julia.wittkowski@uni-marburg.de.'}, {'ForeName': 'Winfried', 'Initials': 'W', 'LastName': 'Rief', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Philipps-University of Marburg, Marburg, Germany.'}, {'ForeName': 'Bettina K', 'Initials': 'BK', 'LastName': 'Doering', 'Affiliation': 'Department of Clinical and Biological Psychology, Catholic University of Eichstätt-Ingolstadt, Eichstätt, Germany.'}]",International journal of behavioral medicine,['10.1007/s12529-020-09933-1']
2081,31699167,Does maternal smoking in pregnancy explain the differences in the body composition trajectory between breastfed and formula-fed infants?,"Growth patterns are known to differ between breastfed and formula-fed infants, but little is known about the relative impact of maternal smoking in pregnancy v. feeding mode on growth trajectory in infancy. We conducted a secondary analysis of a trial, the Tolerance of Infant Goat Milk Formula and Growth Assessment trial involving 290 healthy infants, to examine whether smoking in pregnancy modified the association between feeding mode and body composition of infants. Fat mass (FM) and fat-free mass (FFM) were estimated at 1, 2, 3, 4, 6 and 12 months of age using bioimpedance spectroscopy. Formula-fed infants (n 190) had a higher mean FFM at 4 months (mean difference (MD) 160 g, 95 % CI 50·4, 269·5 g, P < 0·05)) and 6 months (MD 179 g, 95 % CI 41·5, 316·9 g, P < 0·05) compared with the breastfed infants (n 100). Sub-group analysis of breastfed v. formula-fed infants by maternal smoking status in pregnancy showed that there were no differences in the FM and FFM between the breastfed and formula-fed infants whose mothers did not smoke in pregnancy. Formula-fed infants whose mothers smoked in pregnancy were smaller at birth and had a lower FM% and higher FFM% at 1 month compared with infants of non-smoking mothers regardless of feeding mode, but the differences were not significant at other time points. Adequately powered prospective studies with an appropriate design are warranted to better understand the relative impact of maternal smoking, feeding practice and the growth trajectory of infants.",2020,"Formula-fed infants whose mothers smoked in pregnancy were smaller at birth and had a lower FM% and higher FFM% at 1 month compared with infants of non-smoking mothers regardless of feeding mode, but the differences were not significant at other time points.","['290 healthy infants', '160 g']",[],"['mean FFM', 'FM and FFM', 'Fat mass (FM) and fat-free mass (FFM', 'lower FM% and higher FFM']","[{'cui': 'C5191218', 'cui_str': '290'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C4319554', 'cui_str': '160'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0271093', 'cui_str': ""Stargardt's disease""}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205250', 'cui_str': 'High'}]",290.0,0.0563229,"Formula-fed infants whose mothers smoked in pregnancy were smaller at birth and had a lower FM% and higher FFM% at 1 month compared with infants of non-smoking mothers regardless of feeding mode, but the differences were not significant at other time points.","[{'ForeName': 'Shao J', 'Initials': 'SJ', 'LastName': 'Zhou', 'Affiliation': 'School of Agriculture, Food and Wine, The University of Adelaide, Waite Campus, Urrbrae, SA 5064, Australia.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Hawke', 'Affiliation': 'South Australian Health and Medical Research Institute, Adelaide, SA 5000, Australia.'}, {'ForeName': 'Carmel T', 'Initials': 'CT', 'LastName': 'Collins', 'Affiliation': 'South Australian Health and Medical Research Institute, Adelaide, SA 5000, Australia.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Gibson', 'Affiliation': 'School of Agriculture, Food and Wine, The University of Adelaide, Waite Campus, Urrbrae, SA 5064, Australia.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Makrides', 'Affiliation': 'South Australian Health and Medical Research Institute, Adelaide, SA 5000, Australia.'}]",The British journal of nutrition,['10.1017/S0007114519002848']
2082,31711373,A posteriori dietary patterns and risk of inflammatory bowel disease: a meta-analysis of observational studies.,"Inflammatory bowel disease (IBD) is a chronic inflammatory disorder which affects the gastrointestinal tract. Many factors, such as genetics, stress, and dietary patterns have been related to the risk of this disease. Adherence to a prudent/healthy dietary pattern, due to its antioxidant and anti-inflammatory properties, help to reduce the risk of many chronic diseases such as IBD. The results from previous studies regarding the association between dietary patterns and risk of IBD, including Crohn's disease (CD) and ulcerative colitis (UC), are inconsistent. This meta-analysis was performed to evaluate the potential relations between dietary patterns and risk of CD and UC. PubMed and Scopus were searched up to October 2017 for eligible studies. Random-effects or fixed-effects models were used to pool the estimated risks for the highest versus the lowest category of extracted dietary patterns. A total of six studies, including four case-control and two cohort studies with 1099 cases and 263112 controls/participants were included in the meta-analysis. A decreased risk of CD was seen for the highest compared with the lowest categories of healthy dietary pattern (OR/RR = 0.39, 95%CI = 0.16-0.62), while no significant association with western dietary pattern was observed (OR/RR = 0.78, 95% CI: 0.51-1.04). Furthermore, no significant relationship was found between healthy (OR/RR = 0.61, 95%CI = 0.04-1.18, random effects) and western/unhealthy (OR/RR = 0.97, 95% CI: 0.67-1.26) dietary patterns and risk of UC. The results of the current meta-analysis showed that a healthy dietary pattern is associated with a lower risk of CD. Further studies are warranted to confirm these findings.",2020,"Furthermore, no significant relationship was found between healthy (OR/RR = 0.61, 95%CI = 0.04-1.18, random effects) and western/unhealthy (OR/RR = ","['A total of six studies, including four case-control and two cohort studies with 1099 cases and 263112 controls/participants were included in the meta-analysis']",[],"['Inflammatory bowel disease (IBD', ""dietary patterns and risk of IBD, including Crohn's disease (CD) and ulcerative colitis (UC"", 'risk of CD']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0007328', 'cui_str': 'Case Control Studies'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0282458', 'cui_str': 'Meta-Analysis'}]",[],"[{'cui': 'C0021390', 'cui_str': 'Inflammatory bowel disease'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}]",,0.0319231,"Furthermore, no significant relationship was found between healthy (OR/RR = 0.61, 95%CI = 0.04-1.18, random effects) and western/unhealthy (OR/RR = ","[{'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Khorshidi', 'Affiliation': 'Department of Clinical Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences (TUMS), Tehran, Iran.'}, {'ForeName': 'Kurosh', 'Initials': 'K', 'LastName': 'Djafarian', 'Affiliation': 'Department of Clinical Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences (TUMS), Tehran, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Aghayei', 'Affiliation': 'Department of Community Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences (TUMS), Tehran, Iran.'}, {'ForeName': 'Sakineh', 'Initials': 'S', 'LastName': 'Shab-Bidar', 'Affiliation': 'Department of Community Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences (TUMS), Tehran, Iran.'}]",International journal for vitamin and nutrition research. Internationale Zeitschrift fur Vitamin- und Ernahrungsforschung. Journal international de vitaminologie et de nutrition,['10.1024/0300-9831/a000508']
2083,31750709,Overestimating the valuations and preferences of others.,"People often make judgments about their own and others' valuations and preferences. Across 12 studies ( N  = 17,594), we find a robust bias in these judgments such that people overestimate the valuations and preferences of others. This overestimation arises because, when making predictions about others, people rely on their intuitive core representation of the experience (e.g., is the experience generally positive?) in lieu of a more complex representation that might also include countervailing aspects (e.g., is any of the experience negative?). We first demonstrate that the overestimation bias is pervasive for a wide range of positive (Studies 1-5) and negative experiences (Study 6). Furthermore, the bias is not merely an artifact of how preferences are measured (Study 7). Consistent with judgments based on core representations, the bias significantly reduces when the core representation is uniformly positive (Studies 8A-8B). Such judgments lead to a paradox in how people see others trade off between valuation and utility (Studies 9A-9B). Specifically, relative to themselves, people believe that an identically paying other will get more enjoyment from the same experience, but paradoxically, that an identically enjoying other will pay more for the same experience. Finally, consistent with a core representation explanation, explicitly prompting people to consider the entire distribution of others' preferences significantly reduced or eliminated the bias (Study 10). These findings suggest that social judgments of others' preferences are not only largely biased, but they also ignore how others make trade-offs between evaluative metrics. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"Consistent with judgments based on core representations, the bias significantly reduces when the core representation is uniformly positive (Studies 8A-8B).",[],[],[],[],[],[],,0.0363926,"Consistent with judgments based on core representations, the bias significantly reduces when the core representation is uniformly positive (Studies 8A-8B).","[{'ForeName': 'Minah H', 'Initials': 'MH', 'LastName': 'Jung', 'Affiliation': 'Department of Marketing.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Moon', 'Affiliation': 'Department of Operations, Information, and Decisions.'}, {'ForeName': 'Leif D', 'Initials': 'LD', 'LastName': 'Nelson', 'Affiliation': 'Haas School of Business.'}]",Journal of experimental psychology. General,['10.1037/xge0000700']
2084,31865785,Estimated Stroke-Free Survival of Folic Acid Therapy for Hypertensive Adults: Projection Based on the CSPPT.,"The CSPPT (China Stroke Primary Prevention Trial) demonstrated a significant risk reduction of first stroke in hypertensive patients treated with enalapril plus folic acid compared with those with enalapril alone, but the lifetime stroke-free survival associated with the treatment is unknown. By establishing adjusted models for competing risks and an age-based time scale using data from 19 053 participants of the CSPPT, we estimated lifetime incremental stroke-free survival for enalapril-folic acid versus enalapril alone. Compared with enalapril alone, the enalapril plus folic acid treatment projected a mean lifetime stroke-free survival gain of 1.75 months, with an interquartile range from 0.73 to 2.39 months and the maximum gain up to 12.95 months. Subgroup analyses showed greater gain in stroke-free survival in younger, male patients, those with lower baseline folate levels, higher baseline systolic blood pressure, higher baseline total cholesterol and blood glucose, and with MTHFR (methylenetetrahydrofolate reductase) C677T CT or TT genotype. Overall, besides significant benefit in certain subgroups, enalapril plus folic acid treatment for hypertensive patients is associated with a modest gain in lifetime stroke-free survival, compared with enalapril alone.",2020,"Subgroup analyses showed greater gain in stroke-free survival in younger, male patients, those with lower baseline folate levels, higher baseline systolic blood pressure, higher baseline total cholesterol and blood glucose, and with MTHFR (methylenetetrahydrofolate reductase)","['Hypertensive Adults', 'hypertensive patients']","['enalapril', 'enalapril-folic acid versus enalapril', 'enalapril plus folic acid', 'Folic Acid Therapy']","['gain in stroke-free survival', 'baseline systolic blood pressure, higher baseline total cholesterol and blood glucose, and with MTHFR (methylenetetrahydrofolate reductase', 'lifetime stroke-free survival', 'mean lifetime stroke-free survival gain']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0014025', 'cui_str': 'Enalapril'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C4274438', 'cui_str': 'Baseline systolic blood pressure'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0066357', 'cui_str': 'Methylenetetrahydrofolate reductase (NADPH)'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",19053.0,0.0756417,"Subgroup analyses showed greater gain in stroke-free survival in younger, male patients, those with lower baseline folate levels, higher baseline systolic blood pressure, higher baseline total cholesterol and blood glucose, and with MTHFR (methylenetetrahydrofolate reductase)","[{'ForeName': 'Tiantian', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': 'From the College of Pharmacy (T.Z., T.L., J.J.), Jinan University, Guangzhou, China.'}, {'ForeName': 'Tengfei', 'Initials': 'T', 'LastName': 'Lin', 'Affiliation': 'From the College of Pharmacy (T.Z., T.L., J.J.), Jinan University, Guangzhou, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Epidemiology, Fielding School of Public Health, University of California Los Angeles, CA (Y.W.).'}, {'ForeName': 'Binyan', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'National Clinical Research Study Center for Kidney Disease; the State Key Laboratory for Organ Failure Research; Renal Division, Nanfang Hospital, Southern Medical University, Guangzhou, China (B.W., X.Q.).'}, {'ForeName': 'Xianhui', 'Initials': 'X', 'LastName': 'Qin', 'Affiliation': 'National Clinical Research Study Center for Kidney Disease; the State Key Laboratory for Organ Failure Research; Renal Division, Nanfang Hospital, Southern Medical University, Guangzhou, China (B.W., X.Q.).'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Xie', 'Affiliation': 'Department of Clinical Epidemiology and Biostatistics (F.X.).'}, {'ForeName': 'Yimin', 'Initials': 'Y', 'LastName': 'Cui', 'Affiliation': 'Department of Pharmacy (Y.C.), Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Huo', 'Affiliation': 'Department of Cardiology (Y.H.), Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Xiaobin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Population, Family and Reproductive Health, Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland (X.W.).'}, {'ForeName': 'Zugui', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Christiana Care Health System, Newark, Delaware (Z.Z.).'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Jiang', 'Affiliation': 'From the College of Pharmacy (T.Z., T.L., J.J.), Jinan University, Guangzhou, China.'}]","Hypertension (Dallas, Tex. : 1979)",['10.1161/HYPERTENSIONAHA.119.14102']
2085,32060583,[Early salvage radiation therapy of the prostate bed appears to be equally effective compared to adjuvant radiation therapy after radical prostatectomy].,,2020,,[],[],[],[],[],[],,0.0106043,,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Shelan', 'Affiliation': 'Department of Radiation Oncology, Inselspital, Bern University Hospital, University of Bern, Bern, Schweiz.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Aebersold', 'Affiliation': 'Department of Radiation Oncology, Inselspital, Bern University Hospital, University of Bern, Bern, Schweiz.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Ghadjar', 'Affiliation': 'Klinik für Radioonkologie und Strahlentherapie, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany, Augustenburger Platz\xa01, 13353, Berlin, Deutschland. pirus.ghadjar@charite.de.'}]",Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al],['10.1007/s00066-020-01591-2']
2086,31455792,Acute Physical Exercise Can Influence the Accuracy of Metacognitive Judgments.,"Acute exercise generally benefits memory but little research has examined how exercise affects metacognition (knowledge of memory performance). We show that a single bout of exercise can influence metacognition in paired-associate learning. Participants completed 30-min of moderate-intensity exercise before or after studying a series of word pairs (cloud-ivory), and completed cued-recall (cloud-?; Experiments 1 & 2) and recognition memory tests (cloud-? spoon; ivory; drill; choir; Experiment 2). Participants made judgments of learning prior to cued-recall tests (JOLs; predicted likelihood of recalling the second word of each pair when shown the first) and feeling-of-knowing judgments prior to recognition tests (FOK; predicted likelihood of recognizing the second word from four alternatives). Compared to no-exercise control conditions, exercise before encoding enhanced cued-recall in Experiment 1 but not Experiment 2 and did not affect recognition. Exercise after encoding did not influence memory. In conditions where exercise did not benefit memory, it increased JOLs and FOK judgments relative to accuracy (Experiments 1 & 2) and impaired the relative accuracy of JOLs (ability to distinguish remembered from non-remembered items; Experiment 2). Acute exercise seems to signal likely remembering; this has implications for understanding the effects of exercise on metacognition, and for incorporating exercise into study routines.",2019,"Compared to no-exercise control conditions, exercise before encoding enhanced cued-recall in Experiment 1 but not Experiment 2 and did not affect recognition.",[],"['Acute Physical Exercise', 'moderate-intensity exercise']",['relative accuracy of JOLs'],[],"[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}]","[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0022423', 'cui_str': 'Judgement'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",4.0,0.0154391,"Compared to no-exercise control conditions, exercise before encoding enhanced cued-recall in Experiment 1 but not Experiment 2 and did not affect recognition.","[{'ForeName': 'Matthew A', 'Initials': 'MA', 'LastName': 'Palmer', 'Affiliation': 'Department of Psychology, School of Medicine, University of Tasmania, Hobart, Australia. matthew.palmer@utas.edu.au.'}, {'ForeName': 'Kayla', 'Initials': 'K', 'LastName': 'Stefanidis', 'Affiliation': 'Department of Psychology, School of Medicine, University of Tasmania, Hobart, Australia.'}, {'ForeName': 'Ashlee', 'Initials': 'A', 'LastName': 'Turner', 'Affiliation': 'Department of Psychology, School of Medicine, University of Tasmania, Hobart, Australia.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Tranent', 'Affiliation': 'Department of Psychology, School of Medicine, University of Tasmania, Hobart, Australia.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Breen', 'Affiliation': 'Department of Psychology, School of Medicine, University of Tasmania, Hobart, Australia.'}, {'ForeName': 'Talira', 'Initials': 'T', 'LastName': 'Kucina', 'Affiliation': 'Department of Psychology, School of Medicine, University of Tasmania, Hobart, Australia.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Brumby', 'Affiliation': 'Department of Psychology, School of Medicine, University of Tasmania, Hobart, Australia.'}, {'ForeName': 'Glenys A', 'Initials': 'GA', 'LastName': 'Holt', 'Affiliation': 'Department of Psychology, School of Medicine, University of Tasmania, Hobart, Australia.'}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Fell', 'Affiliation': 'School of Health Science, University of Tasmania, Hobart, Australia.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Sauer', 'Affiliation': 'Department of Psychology, School of Medicine, University of Tasmania, Hobart, Australia.'}]",Scientific reports,['10.1038/s41598-019-48861-3']
2087,33095469,Testing the Impact of FFC-AL-EIT on Psychosocial and Behavioral Outcomes in Assisted Living.,"BACKGROUND


This study tested the impact of Function Focused Care for Assisted Living Using the Evidence Integration Triangle (FFC-AL-EIT) on: (1) care interactions between residents and direct care staff; and (2) behavior and psychological symptoms associated with dementia among residents.
DESIGN


This was a randomized controlled trial.
SETTING


A total of 59 assisted living facilities in Maryland, Pennsylvania, and Massachusetts participated.
PARTICIPANTS


The sample included 550 mostly White (98%), female (69%) residents with a mean age of 89.30 (standard deviation = 7.63) years.
INTERVENTION


The four-step FFC-AL-EIT intervention was implemented by a function focused care nurse facilitator working with a facility champion over 12 months. The steps included: (1) environment and policy assessments; (2) education; (3) establishing resident function focused care service plans; and (4) mentoring and motivating.
MEASURES


Resident descriptive data (e.g., age, sex, education, and comorbidities), depression, agitation, resistiveness to care, and the quality of care interactions were obtained at baseline and 4 and 12 months. Treatment fidelity data included environment and policy assessments, performance of function focused care by staff, and service plan assessments.
RESULTS


There was a significant positive treatment effect related to depression, agitation, resistiveness to care, and quality of care interactions with either less decline or some improvement in these behaviors and symptoms in the treatment versus control group.
CONCLUSION


The study provides some statistical support, which may not necessarily be clinically significant evidence, for psychosocial outcomes of residents and care interactions between staff and residents in assisted living settings.",2020,"There was a significant positive treatment effect related to depression, agitation, resistiveness to care, and quality of care interactions with either less decline or some improvement in these behaviors and symptoms in the treatment versus control group.
","['residents and direct care staff; and (2) behavior and psychological symptoms associated with dementia among residents', 'A total of 59 assisted living facilities in Maryland, Pennsylvania, and Massachusetts participated.\nPARTICIPANTS\n\n\nThe sample included 550 mostly White (98%), female (69%) residents with a mean age of 89.30 (standard deviation = 7.63) years']","['environment and policy assessments; (2) education; (3) establishing resident function focused care service plans; and (4) mentoring and motivating', 'FFC-AL-EIT']","['environment and policy assessments, performance of function focused care by staff, and service plan assessments', 'Psychosocial and Behavioral Outcomes', 'depression, agitation, resistiveness to care, and quality of care interactions', 'Resident descriptive data (e.g., age, sex, education, and comorbidities), depression, agitation, resistiveness to care, and the quality of care interactions']","[{'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0233397', 'cui_str': 'Psychological symptom'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0872103', 'cui_str': 'Assisted living facility'}, {'cui': 'C0024858', 'cui_str': 'Maryland'}, {'cui': 'C0030853', 'cui_str': 'Pennsylvania'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C3844103', 'cui_str': '550'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0242456', 'cui_str': 'Policy'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0025369', 'cui_str': 'Mentors'}]","[{'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0242456', 'cui_str': 'Policy'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0034379', 'cui_str': 'Quality of Care'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}]",550.0,0.0428577,"There was a significant positive treatment effect related to depression, agitation, resistiveness to care, and quality of care interactions with either less decline or some improvement in these behaviors and symptoms in the treatment versus control group.
","[{'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Resnick', 'Affiliation': 'University of Maryland School of Nursing, Baltimore, Maryland, USA.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Boltz', 'Affiliation': 'Pennsylvania State University College of Nursing, University Park, Pennsylvania, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Galik', 'Affiliation': 'University of Maryland School of Nursing, Baltimore, Maryland, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Fix', 'Affiliation': 'Pennsylvania State University College of Nursing, University Park, Pennsylvania, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Holmes', 'Affiliation': 'University of Maryland School of Nursing, Baltimore, Maryland, USA.'}, {'ForeName': 'Shijun', 'Initials': 'S', 'LastName': 'Zhu', 'Affiliation': 'University of Maryland School of Nursing, Baltimore, Maryland, USA.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Barr', 'Affiliation': 'University of Maryland School of Nursing, Baltimore, Maryland, USA.'}]",Journal of the American Geriatrics Society,['10.1111/jgs.16886']
2088,33095509,Tolerability and Efficacy of Two Doses of Aerosolized Albuterol in Ventilated Infants with BPD: A Randomized Controlled Crossover Trial.,"RATIONALE


Aerosolized albuterol is widely used, but its tolerability and efficacy in infants with severe bronchopulmonary dysplasia (sBPD) is not well established.
OBJECTIVES


To compare the tolerability and efficacy of two dose levels of aerosolized albuterol to saline placebo in infants with sBPD.
METHODS


Single-center, multiple-crossover trial in 24 ventilated very preterm infants with sBPD. Albuterol (1.25mg, 2.5mg) and 3ml of normal saline were administered every 4 hours during separate 24-hour treatment periods assigned in random order with a 6-hour washout phase between periods. The primary outcome was the absolute change (post - pre therapy) in expiratory flow at 75% of exhalation (EF75). Secondary endpoints were changes in ventilator parameters, vital signs, and heart arrhythmia.
RESULTS


Average within subject EF75 values improved with each therapy: saline placebo (+0.45L/min ± 2.5, p=0.04), 1.25mg of albuterol (+0.70L/min ± 2.4, p<0.001), and 2.5mg of albuterol (+0.38L/min ± 2.4, p=0.06). However, 1.25mg of albuterol (0.26L/min; 95% CI -0.19, 0.72) and 2.5mg (-0.10L/min; 95% CI -0.77, 0.57) produced similar changes in EF75 when compared to saline. All secondary outcomes were similar between saline and 1.25mg of albuterol. Peak inspiratory pressure needed to deliver goal tidal volumes (7.5% relative decrease, 95% CI 2.6, 12.3) and heart rate (6.5% increase, 95% CI 2.2, 10.8) differed significantly between albuterol 2.5mg and saline.
CONCLUSION


Albuterol at 1.25mg and 2.5mg, compared to aerosolized saline, did not affect EF75 in infants with sBPD receiving invasive ventilation. Greater improvement in inspiratory pressures with albuterol 2.5mg suggests benefit, but close heart monitoring may be indicated. This article is protected by copyright. All rights reserved.",2020,"Albuterol at 1.25mg and 2.5mg, compared to aerosolized saline, did not affect EF75 in infants with sBPD receiving invasive ventilation.","['infants with sBPD receiving invasive ventilation', 'Ventilated Infants with BPD', 'infants with severe bronchopulmonary dysplasia (sBPD', 'infants with sBPD', '24 ventilated very preterm infants with sBPD']","['Aerosolized Albuterol', 'therapy: saline placebo', 'Albuterol', 'albuterol', 'aerosolized albuterol to saline placebo', 'aerosolized saline']","['Peak inspiratory pressure needed to deliver goal tidal volumes', 'changes in ventilator parameters, vital signs, and heart arrhythmia', 'tolerability and efficacy', 'absolute change (post - pre therapy) in expiratory flow at 75% of exhalation (EF75', 'Tolerability and Efficacy', 'inspiratory pressures', 'heart rate']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0006287', 'cui_str': 'Bronchopulmonary dysplasia of newborn'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0006012', 'cui_str': 'Borderline personality disorder'}, {'cui': 'C3897192', 'cui_str': 'Very preterm infant'}]","[{'cui': 'C0001927', 'cui_str': 'Albuterol'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0232021', 'cui_str': 'Peak inspiratory pressure'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",24.0,0.615451,"Albuterol at 1.25mg and 2.5mg, compared to aerosolized saline, did not affect EF75 in infants with sBPD receiving invasive ventilation.","[{'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Napolitano', 'Affiliation': ""Respiratory Therapy Department, Children's Hospital of Philadelphia.""}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Dysart', 'Affiliation': ""Division of Neonatology, Children's Hospital of Philadelphia.""}, {'ForeName': 'Leane', 'Initials': 'L', 'LastName': 'Soorikian', 'Affiliation': ""Respiratory Therapy Department, Children's Hospital of Philadelphia.""}, {'ForeName': 'Huayan', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': ""Division of Neonatology, Children's Hospital of Philadelphia.""}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Panitch', 'Affiliation': ""Division of Pulmonary Medicine, Children's Hospital of Philadelphia.""}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Jensen', 'Affiliation': ""Division of Neonatology, Children's Hospital of Philadelphia.""}]",Pediatric pulmonology,['10.1002/ppul.25131']
2089,33091332,Development and validation of prognostic nomogram for lung cancer patients below the age of 45 years.,"This study aimed to establish a nomogram for the prognostic prediction of patients with early-onset lung cancer (EOLC) in both overall survival (OS) and cancer-specific survival (CSS). We retrieved EOLC patients diagnosed between 2004 and 2015 from the Surveillance, Epidemiology, and End Results (SEER) database and further divided them into training and validation sets randomly. The prognostic nomogram for predicting 3-, 5- and 10-years OS and CSS was established based on the relative clinical variables determined by the multivariate Cox analysis results. Furthermore, the predictive performance of the nomogram was assessed by concordance index (C-index), calibration curve, receiver operating characteristic (ROC) curve and decision curve analysis (DCA) curve. A total of 1,822 EOLC patients were selected and randomized into a training cohort (1,275, 70%) and a validation cohort (547, 30%). The nomograms were established based on the statistical results of Cox analysis. In training set, the C-indexes for OS and CSS prediction were 0.797 (95% confidence interval [CI]: 0.773-0.818) and 0.794 (95%CI:0.771-0.816). Significant agreement in the calibration curves was noticed in the nomogram models. The results of ROC and DCA indicated nomograms possessed better predict performance compared with TNM-stage and SEER-stage. Furthermore, the areas under the curve (AUC) of the nomogram for OS and CSS prediction in ROC analysis were 0.766 (95%CI:0.745-0.787) and 0.782 (95%CI:0.760-0.804) respectively. In conclusion, the prognostic nomogram provided an accurate prediction of 3-, 5-, and 10-year OS and CSS of EOLC patients which contributed clinicians to optimize individualized treatment plans.",2020,"In training set, the C-indexes for OS and CSS prediction were 0.797 (95% confidence interval [CI]: 0.773-0.818) and 0.794 (95%CI:0.771-0.816).","['1,822 EOLC patients', 'EOLC patients diagnosed between 2004 and 2015 from the Surveillance, Epidemiology, and End Results (SEER) database and further divided them into training and validation sets randomly', 'lung cancer patients below the age of 45 years', 'patients with early-onset lung cancer (EOLC']",[],"['concordance index (C-index), calibration curve, receiver operating characteristic (ROC) curve and decision curve analysis (DCA) curve', 'overall survival (OS) and cancer-specific survival (CSS', 'calibration curves']","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0014507', 'cui_str': 'Epidemiology'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],"[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0006751', 'cui_str': 'Calibration'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}]",1822.0,0.0552124,"In training set, the C-indexes for OS and CSS prediction were 0.797 (95% confidence interval [CI]: 0.773-0.818) and 0.794 (95%CI:0.771-0.816).","[{'ForeName': 'Kaixin', 'Initials': 'K', 'LastName': 'Qu', 'Affiliation': ""Department of Respiratory Medicine, Funan County People's Hospital, Anhui, China.""}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Dai', 'Affiliation': ""Department of Medicine, Funan County People's Hospital, Anhui, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': ""Department of Respiratory Medicine, Funan County People's Hospital, Anhui, China.""}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Department of Endocrinology, Punan Hospital of Pudong District, Shanghai, China.'}, {'ForeName': 'Tongjia', 'Initials': 'T', 'LastName': 'Xia', 'Affiliation': 'Department of Endocrinology, The First Affiliated Hospital of Anhui Medical University, Anhui, China.'}, {'ForeName': 'Qikui', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Department of Chest Surgery, Anhui Chest Hospital, Anhui, China.'}, {'ForeName': 'Qingqing', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'Department of Tuberculosis, Anhui Chest Hospital, Anhui, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Zhu', 'Affiliation': 'Department of Respiratory Medicine, The Second Affiliated Hospital of Xuzhou Medical University, Jiangsu China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'Department of Interventional Aulmonary and Endoscopy Center, Anhui Chest Hospital, Anhui, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Yan', 'Affiliation': 'Department of Oncology, Anhui Cancer Hospital, Anhui, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Shu', 'Affiliation': 'Department of Respiratory Medicine, The Fourth Affiliated Hospital of Anhui Medical University, Anhui, China.'}]",Bosnian journal of basic medical sciences,['10.17305/bjbms.2020.5079']
2090,33091360,"Long-term efficacy and safety of drug-coated balloons versus drug-eluting stents for small coronary artery disease (BASKET-SMALL 2): 3-year follow-up of a randomised, non-inferiority trial.","BACKGROUND


In the treatment of de-novo coronary small vessel disease, drug-coated balloons (DCBs) are non-inferior to drug-eluting stents (DESs) regarding clinical outcome up to 12 months, but data beyond 1 year is sparse. We aimed to test the long-term efficacy and safety of DCBs regarding clinical endpoints in an all-comer population undergoing percutaneous coronary intervention.
METHODS


In this prespecified long-term follow-up of a multicentre, randomised, open-label, non-inferiority trial, patients from 14 clinical sites in Germany, Switzerland, and Austria with de-novo lesions in coronary vessels <3 mm and an indication for percutaneous coronary intervention were randomly assigned 1:1 to DCB or second-generation DES and followed over 3 years for major adverse cardiac events (ie, cardiac death, non-fatal myocardial infarction, and target-vessel revascularisation [TVR]), all-cause death, probable or definite stent thrombosis, and major bleeding (Bleeding Academic Research Consortium bleeding type 3-5). Analyses were performed on the full analysis set according to the modified intention-to-treat principle. Dual antiplatelet therapy was recommended for 1 month after DCB and 6 months after DES with stable symptoms, but 12 months with acute coronary syndromes. The study is registered with ClinicalTrials.gov, NCT01574534 and is ongoing.
FINDINGS


Between April 10, 2012, and Feb 1, 2017, of 883 patients assessed, 758 (86%) patients were randomly assigned to the DCB group (n=382) or the DES group (n=376). The Kaplan-Meier estimate of the rate of major adverse cardiac events was 15% in both the DCB and DES groups (hazard ratio [HR] 0·99, 95% CI 0·68-1·45; p=0·95). The two groups were also very similar concerning the single components of adverse cardiac events: cardiac death (Kaplan-Meier estimate 5% vs 4%, HR 1·29, 95% CI 0·63-2·66; p=0·49), non-fatal myocardial infarction (both Kaplan-Meier estimate 6%, HR 0·82, 95% CI 0·45-1·51; p=0·52), and TVR (both Kaplan-Meier estimate 9%, HR 0·95, 95% CI 0·58-1·56; p=0·83). Rates of all-cause death were very similar in DCB versus DES patients (both Kaplan-Meier estimate 8%, HR 1·05, 95% CI 0·62-1·77; p=0·87). Rates of probable or definite stent thrombosis (Kaplan-Meier estimate 1% vs 2%; HR 0·33, 95% CI 0·07-1·64; p=0·18) and major bleeding (Kaplan-Meier estimate 2% vs 4%, HR 0·43, 95% CI 0·17-1·13; p=0·088) were numerically lower in DCB versus DES, however without reaching significance.
INTERPRETATION


There is maintained efficacy and safety of DCB versus DES in the treatment of de-novo coronary small vessel disease up to 3 years.
FUNDING


Swiss National Science Foundation, Basel Cardiovascular Research Foundation, and B Braun Medical.",2020,"The two groups were also very similar concerning the single components of adverse cardiac events: cardiac death (Kaplan-Meier estimate 5% vs 4%, HR 1·29, 95% CI 0·63-2·66; p=0·49), non-fatal myocardial infarction (both Kaplan-Meier estimate 6%, HR 0·82, 95% CI 0·45-1·51; p=0·52), and TVR (both Kaplan-Meier estimate 9%, HR 0·95, 95% CI 0·58-1·56; p=0·83).","['patients from 14 clinical sites in Germany, Switzerland, and Austria with de-novo lesions in coronary vessels <3 mm and an indication for percutaneous coronary intervention', 'Between April 10, 2012, and Feb 1, 2017, of 883 patients assessed, 758 (86%) patients', 'all-comer population undergoing percutaneous coronary intervention']","['DCB versus DES', 'drug-coated balloons versus drug-eluting stents', 'DES', 'DCB or second-generation DES', 'DCB', 'DCBs']","['major bleeding', 'rate of major adverse cardiac events', 'single components of adverse cardiac events: cardiac death (Kaplan-Meier estimate', 'TVR', 'Rates of all-cause death', 'non-fatal myocardial infarction', 'Rates of probable or definite stent thrombosis']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0004348', 'cui_str': 'Austria'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0010075', 'cui_str': 'Coronary Vessels'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0000370', 'cui_str': ""3-3'dichlorobenzidine""}, {'cui': 'C0011702', 'cui_str': '4-(4-Amino-4-Carboxybutyl)-1-(5-Amino-5-Carboxypentyl)-3,5-bis(3-Amino-3-Carboxypropyl)pyridinium'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0079411', 'cui_str': 'Generations'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0439544', 'cui_str': 'Definite'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}]",,0.203546,"The two groups were also very similar concerning the single components of adverse cardiac events: cardiac death (Kaplan-Meier estimate 5% vs 4%, HR 1·29, 95% CI 0·63-2·66; p=0·49), non-fatal myocardial infarction (both Kaplan-Meier estimate 6%, HR 0·82, 95% CI 0·45-1·51; p=0·52), and TVR (both Kaplan-Meier estimate 9%, HR 0·95, 95% CI 0·58-1·56; p=0·83).","[{'ForeName': 'Raban V', 'Initials': 'RV', 'LastName': 'Jeger', 'Affiliation': 'University Hospital Basel, University of Basel, Basel, Switzerland. Electronic address: raban.jeger@usb.ch.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Farah', 'Affiliation': 'Knappschaftskrankenhaus, Klinikum Westfalen, Dortmund, Germany.'}, {'ForeName': 'Marc-Alexander', 'Initials': 'MA', 'LastName': 'Ohlow', 'Affiliation': 'Central Clinic, Bad Berka, Germany.'}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Mangner', 'Affiliation': 'Herzzentrum Dresden, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Möbius-Winkler', 'Affiliation': 'University Hospital Jena, Jena, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Weilenmann', 'Affiliation': 'Cantonal Hospital St Gallen, St Gallen, Switzerland.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Wöhrle', 'Affiliation': 'Klinikum Friedrichshafen, Medical Campus Lake Constance, Friedrichshafen, Germany.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Stachel', 'Affiliation': 'Heart Center Leipzig, University Hospital, Leipzig, Germany.'}, {'ForeName': 'Sinisa', 'Initials': 'S', 'LastName': 'Markovic', 'Affiliation': 'University Hospital Ulm, Ulm, Germany.'}, {'ForeName': 'Gregor', 'Initials': 'G', 'LastName': 'Leibundgut', 'Affiliation': 'Cantonal Hospital Baselland, Liestal, Switzerland.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Rickenbacher', 'Affiliation': 'University Hospital Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Osswald', 'Affiliation': 'University Hospital Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Cattaneo', 'Affiliation': 'University Hospital Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Gilgen', 'Affiliation': 'University Hospital Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Kaiser', 'Affiliation': 'University Hospital Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Scheller', 'Affiliation': 'University Hospital Saarland, Homburg, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(20)32173-5']
2091,33091438,The placebo effect in breath holding: a preliminary behavioral investigation.,"PURPOSE


This study seeks to evaluate effects of expectations and conditioning on dry breath holding.
METHODS


Sixty healthy volunteers were subdivided into 3 groups and were tested across 4 breath holding trials. Participants of the Control group (C) did not undergo any manipulation. Participants of the placebo (P) and nocebo (N) groups were told that they would inhale O2 (actually sham O2) or CO2 (actually sham CO2) along with opposite information that this would enhance or worsen their breath holding time, respectively. Opposite conditioning paradigms based on false visual feedback were employed to reinforce participants' positive (placebo) and negative (nocebo) beliefs.
RESULTS


The P group showed the greater increase in breath holding time from baseline to the last trial (p = 0.0001) and the longest breath holding time in the last trial compared to the C group (p = 0.02) and the N group (p = 0.0001). Additionally, in the last trial the P group showed a greater decrease in peripheral oxygen saturation (SpO2) as compared to the C group (p = 0.04) and the N group (p = 0.001). Heart rate (HR) was accelerated in the N group during breath holding (in comparison to the P group [p = 0.04] and C group [p = 0.04]).
CONCLUSIONS


Psychological components can affect behavioral and physiological parameters in breath holding. This study may inform future research about the role of placebo and nocebo effects for conditions in which critical functions are at play.",2020,The P group showed the greater increase in breath holding time from baseline to the last trial (p = 0.0001) and the longest breath holding time in the last trial compared to the C group (p = 0.02) and the N group (p = 0.0001).,['Sixty healthy volunteers'],"['placebo', 'placebo (P) and nocebo (N) groups were told that they would inhale O2 (actually sham O2) or CO2 (actually sham CO2']","['breath holding time', 'longest breath holding time', 'peripheral oxygen saturation (SpO2', 'Heart rate (HR']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3658218', 'cui_str': 'Nocebo'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}]","[{'cui': 'C0235744', 'cui_str': 'Interrupted breathing'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C2317096', 'cui_str': 'Peripheral oxygen saturation'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",60.0,0.145215,The P group showed the greater increase in breath holding time from baseline to the last trial (p = 0.0001) and the longest breath holding time in the last trial compared to the C group (p = 0.02) and the N group (p = 0.0001).,"[{'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Piedimonte', 'Affiliation': 'Department of Neuroscience ""Rita Levi Montalcini"", University of Turin, Italy. Electronic address: alessandro.piedimonte@unito.it.'}, {'ForeName': 'Diletta', 'Initials': 'D', 'LastName': 'Barbiani', 'Affiliation': 'Department of Neuroscience ""Rita Levi Montalcini"", University of Turin, Italy. Electronic address: diletta.barbiani@edu.unito.it.'}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'Benedetti', 'Affiliation': 'Department of Neuroscience ""Rita Levi Montalcini"", University of Turin, Italy; Medicine & Physiology of Hypoxia, Plateau Rosa Laboratories, Breuil-Cervinia, Italy, Zermatt, Switzerland. Electronic address: fabrizio.benedetti@unito.it.'}, {'ForeName': 'Denisa A', 'Initials': 'DA', 'LastName': 'Zamfira', 'Affiliation': 'Department of Neuroscience ""Rita Levi Montalcini"", University of Turin, Italy. Electronic address: denisa.zamfira@edu.unito.it.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Carlino', 'Affiliation': 'Department of Neuroscience ""Rita Levi Montalcini"", University of Turin, Italy. Electronic address: elisa.carlino@unito.it.'}]",Neuroscience letters,['10.1016/j.neulet.2020.135434']
2092,33091455,Combination of Non-Surgical Endodontic and Vital Pulp Therapy for Management of Mature Permanent Mandibular Molar Teeth with Symptomatic Irreversible Pulpitis and Apical Periodontitis.,"INTRODUCTION


This prospective study evaluated the outcome of a combination of non-surgical endodontic (NSET) and vital pulp therapy (VPT) for the management of mature permanent mandibular molar tooth with symptomatic irreversible pulpitis (SIP) and apical periodontitis (AP).
METHOD


Institutional ethical clearance was obtained. Mandibular molar teeth (n= 60) with a definitive diagnosis of SIP and AP with a radiographic periapical index score (PAI) of ≥3 in either one of the roots (mesial or distal) were included. Block randomization was used for allocation. In the NSET group (n=30), single visit NSET was performed using a standardized operating protocol. In NSET-VPT group (n=30), subsequent to full pulpotomy, the root orifice where a vital pulp was observed (as determined by the arrest of pulpal bleed on application of 2.5% sodium hypochlorite pressure pack), an MTA radicular barrier was placed, and it was covered with light-cured RMGIC. NSET was performed in the root exhibiting PAI score ≥3. The tooth was permanently restored. Postoperative pain was assessed at 24, 48 and 72- hours. Teeth were followed up clinically and radiographically at 12-months. Presence/absence of symptoms and change in PAI scores were noted. The data was statistically analyzed.
RESULTS


The success rate was 90% in the NSET group and 93.3% in the NSET-VPT group. On an inter-group comparison between the proportion of teeth healed and non-healed (radiographic), there was no significant difference (p>0.05).
CONCLUSION


The combination of NSET and VPT is a viable biologically based minimally invasive treatment option for multi-rooted mandibular teeth with SIP and AP.",2020,The success rate was 90% in the NSET group and 93.3% in the NSET-VPT group.,"['Mandibular molar teeth (n= 60) with a definitive diagnosis of SIP and AP with a radiographic periapical index score (PAI) of ≥3 in either one of the roots (mesial or distal) were included', 'mature permanent mandibular molar tooth with symptomatic irreversible pulpitis (SIP) and apical periodontitis (AP', 'Mature Permanent Mandibular Molar Teeth with Symptomatic Irreversible Pulpitis and Apical Periodontitis']","['NSET-VPT', 'NSET', 'combination of non-surgical endodontic (NSET) and vital pulp therapy (VPT', 'NSET and VPT', 'Combination of Non-Surgical Endodontic and Vital Pulp Therapy']","['success rate', 'Postoperative pain', 'PAI scores', 'proportion of teeth healed and non-healed (radiographic']","[{'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0443196', 'cui_str': 'Definitive'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0031030', 'cui_str': 'Apical periodontitis'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0729269', 'cui_str': 'Periapical'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205286', 'cui_str': 'Mature'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}]","[{'cui': 'C0398946', 'cui_str': 'Periapical surgery of tooth'}, {'cui': 'C0442732', 'cui_str': 'Vital'}, {'cui': 'C1306815', 'cui_str': 'Pulp treatment'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0729269', 'cui_str': 'Periapical'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0205301', 'cui_str': 'Non-healed'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}]",,0.0401866,The success rate was 90% in the NSET group and 93.3% in the NSET-VPT group.,"[{'ForeName': 'Bhawna', 'Initials': 'B', 'LastName': 'Koli', 'Affiliation': 'Division of Conservative Dentistry and Endodontics, Centre for Dental Education and Research, All India Institute of Medical Sciences , New Delhi-110029, India.'}, {'ForeName': 'Amrita', 'Initials': 'A', 'LastName': 'Chawla', 'Affiliation': 'Division of Conservative Dentistry and Endodontics, Centre for Dental Education and Research, All India Institute of Medical Sciences , New Delhi-110029, India. Electronic address: dr.amritachawla@gmail.com.'}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Logani', 'Affiliation': 'Division of Conservative Dentistry and Endodontics, Centre for Dental Education and Research, All India Institute of Medical Sciences , New Delhi-110029, India.'}, {'ForeName': 'Vijay', 'Initials': 'V', 'LastName': 'Kumar', 'Affiliation': 'Division of Conservative Dentistry and Endodontics, Centre for Dental Education and Research, All India Institute of Medical Sciences , New Delhi-110029, India.'}, {'ForeName': 'Sidhartha', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'Division of Conservative Dentistry and Endodontics, Centre for Dental Education and Research, All India Institute of Medical Sciences , New Delhi-110029, India.'}]",Journal of endodontics,['10.1016/j.joen.2020.10.010']
2093,33091468,"Translational research on the role of formula stability in Hetter's Phenol-Croton oil peels: analysis of chemical studies and clinical outcomes from a randomized, double-blinded, split-face controlled trial.",,2020,,"[""Hetter's""]",['Phenol-Croton oil peels'],[],[],"[{'cui': 'C0031428', 'cui_str': 'Phenols'}, {'cui': 'C0010372', 'cui_str': 'Croton Oil'}, {'cui': 'C0237849', 'cui_str': 'Peeling of skin'}]",[],,0.720571,,"[{'ForeName': 'Ideli Cristhina', 'Initials': 'IC', 'LastName': 'Neitzke', 'Affiliation': 'Department of Dermatology, Hospital Heliopolis, Sao Paulo, Brazil.'}, {'ForeName': 'Daniella', 'Initials': 'D', 'LastName': 'de Grande Curi', 'Affiliation': 'Department of Dermatology, Hospital Heliopolis, Sao Paulo, Brazil.'}, {'ForeName': 'Erica Miyake', 'Initials': 'EM', 'LastName': 'Lin', 'Affiliation': 'Department of Dermatology, The Warren Alpert Medical School of Brown University, Providence, RI.'}, {'ForeName': 'Kachiu Cecilia', 'Initials': 'KC', 'LastName': 'Lee', 'Affiliation': 'Department of Dermatology, Temple University, Philadelphia, PA.'}, {'ForeName': 'Seaver L', 'Initials': 'SL', 'LastName': 'Soon', 'Affiliation': 'The Skin Clinic MD, San Diego, CA.'}, {'ForeName': 'Ana Cecília', 'Initials': 'AC', 'LastName': 'Lunardelli Bittencourt', 'Affiliation': 'Department of Dermatology, Hospital Heliopolis, Sao Paulo, Brazil.'}, {'ForeName': 'Caroline Motta', 'Initials': 'CM', 'LastName': 'Aguiar', 'Affiliation': 'Department of Dermatology, Hospital Heliopolis, Sao Paulo, Brazil.'}, {'ForeName': 'Domingos Jordão', 'Initials': 'DJ', 'LastName': 'Neto', 'Affiliation': 'Department of Dermatology, Hospital Heliopolis, Sao Paulo, Brazil.'}, {'ForeName': 'Amanda Roderjan', 'Initials': 'AR', 'LastName': 'Cray da Costa Filha', 'Affiliation': 'Department of Pharmaceutical Sciences, State University of Ponta Grossa, Ponta Grossa, PR, Brazil.'}, {'ForeName': 'Flávio Luís', 'Initials': 'FL', 'LastName': 'Beltrame', 'Affiliation': 'Department of Pharmaceutical Sciences, State University of Ponta Grossa, Ponta Grossa, PR, Brazil.'}, {'ForeName': 'Patrícia Mathias', 'Initials': 'PM', 'LastName': 'Döll-Boscardin', 'Affiliation': 'Department of Pharmaceutical Sciences, State University of Ponta Grossa, Ponta Grossa, PR, Brazil.'}, {'ForeName': 'Carlos Gustavo', 'Initials': 'CG', 'LastName': 'Wambier', 'Affiliation': 'Department of Dermatology, The Warren Alpert Medical School of Brown University, Providence, RI. Electronic address: carlos_wambier@brown.edu.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2020.10.024']
2094,33091520,"Point of care, bone marrow mononuclear cell therapy in ischemic heart failure patients personalized for cell potency: 12-month feasibility results from CardiAMP heart failure roll-in cohort.","AIM


Heart failure following myocardial infarction (MI) is a potentially lethal problem with a staggering incidence. The CardiAMP Heart Failure trial represents the first attempt to personalize marrow-derived cell-based therapy to individuals with cell characteristics associated with beneficial responses in prior trials. Before the initiation of the randomized pivotal trial, an open-label ""roll-in cohort"" was completed to ensure the feasibility of the protocol's procedures.
METHODS


Patients with chronic post-MI heart failure (NYHA class II-III) receiving stable, guideline-directed medical therapy with a left ventricular ejection fraction between 20 and 40% were eligible. Two weeks prior to treatment, a ~ 5 ml bone marrow aspiration was performed to examine ""cell potency"". On treatment day, a 60 mL bone marrow aspiration, bone marrow mononuclear cell (BM MNC) enrichment and transendocardial injection of 200 million BM MNC's was performed in a single, point of care encounter. Patients were then followed to assess clinical outcomes.
RESULTS


The cell potency small volume bone marrow aspirate, the 60 mL bone marrow aspirate, and transendocardial injections were well tolerated in 10 patients enrolled. There were no serious adverse events related to bone marrow aspiration or cell delivery. Improvement in 6-min walk distance was observed at 6 months (+47.8 m, P = 0.01) and trended to improvement at 12 months (+46.4, P = 0.06). Similarly, trends to improved NYHA heart failure functional class, quality of life, left ventricular ejection fraction and recruitment of previously akinetic left ventricular wall segments were observed.
CONCLUSION


All CardiAMP HF protocol procedures were feasible and well tolerated. Favorable functional, echo and quality of life trends suggest this approach may offer promise for patients with post MI heart failure. The randomized CardiAMP Heart Failure pivotal trial is underway to confirm the efficacy of this approach.
CLINICAL TRIAL REGISTRATION


https://clinicaltrials.gov/ct2/show/NCT02438306.",2020,"Improvement in 6-min walk distance was observed at 6 months (+47.8 m, P = 0.01) and trended to improvement at 12 months (+46.4, P = 0.06).","['Patients with chronic post-MI heart failure (NYHA class II-III) receiving stable, guideline-directed medical therapy with a left ventricular ejection fraction between 20 and 40% were eligible', '10 patients enrolled', 'patients with post MI heart failure']","['bone marrow mononuclear cell therapy', ""60\u202fmL bone marrow aspiration, bone marrow mononuclear cell (BM MNC) enrichment and transendocardial injection of 200 million BM MNC's""]","['feasible and well tolerated', 'NYHA heart failure functional class, quality of life, left ventricular ejection fraction and recruitment of previously akinetic left ventricular wall segments', '6-min walk distance']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C1275491', 'cui_str': 'New York Heart Association Classification'}, {'cui': 'C0441886', 'cui_str': 'Class 2'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}]","[{'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C1294062', 'cui_str': 'Mononuclear cell count'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0398523', 'cui_str': 'Bone marrow aspiration procedure'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C1881839', 'cui_str': '1000000'}]","[{'cui': 'C1275491', 'cui_str': 'New York Heart Association Classification'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0233568', 'cui_str': 'Akinetic'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0205380', 'cui_str': 'Walled'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}]",10.0,0.0648568,"Improvement in 6-min walk distance was observed at 6 months (+47.8 m, P = 0.01) and trended to improvement at 12 months (+46.4, P = 0.06).","[{'ForeName': 'Amish N', 'Initials': 'AN', 'LastName': 'Raval', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, WI, United States of America. Electronic address: anr@medicine.wisc.edu.'}, {'ForeName': 'Peter V', 'Initials': 'PV', 'LastName': 'Johnston', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, United States of America.'}, {'ForeName': 'Henricus J', 'Initials': 'HJ', 'LastName': 'Duckers', 'Affiliation': 'BioCardia Inc., San Carlos, CA, United States of America.'}, {'ForeName': 'Thomas D', 'Initials': 'TD', 'LastName': 'Cook', 'Affiliation': 'Department of Biostatistics and Medical Informatics, University of Wisconsin, Madison, WI, United States of America.'}, {'ForeName': 'Jay H', 'Initials': 'JH', 'LastName': 'Traverse', 'Affiliation': 'Minneapolis Heart Institute Foundation at Abbott Northwestern Hospital, Minneapolis, MN, United States of America.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Altman', 'Affiliation': 'BioCardia Inc., San Carlos, CA, United States of America.'}, {'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Dhingra', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, WI, United States of America.'}, {'ForeName': 'Peiman', 'Initials': 'P', 'LastName': 'Hematti', 'Affiliation': 'Division of Hematology and Oncology, Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, WI, United States of America.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Borrello', 'Affiliation': 'Division of Immunology and Hematopoiesis, Department of Oncology, Johns Hopkins University School of Medicine, Baltimore, MD, United States of America.'}, {'ForeName': 'R David', 'Initials': 'RD', 'LastName': 'Anderson', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Medicine, University of Florida, Gainesville, FL, United States of America.'}, {'ForeName': 'Carl J', 'Initials': 'CJ', 'LastName': 'Pepine', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Medicine, University of Florida, Gainesville, FL, United States of America.'}]",International journal of cardiology,['10.1016/j.ijcard.2020.10.043']
2095,33091549,Intra-articular platelet-rich plasma combined with hyaluronic acid injection for knee osteoarthritis is superior to PRP or HA alone in inhibiting inflammation and improving pain and function.,"PURPOSE


The goal of this study was to evaluate the effectiveness and explore the therapeutic mechanisms of PRP combined with HA as a treatment for knee osteoarthritis (KOA).
METHODS


In total, 122 knees were randomly divided into HA (34 knees), PRP (40 knees), and PRP+HA (48 knees) groups. Platelet densities in whole blood and PRP were examined using Wright-Giemsa staining. Visual Analogue Scale (VAS), Lequesne, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Lysholm scores and postoperative complications were evaluated. High-frequency color Doppler imaging was used to observe the synovium and cartilage. Enzyme-linked immunosorbent assays (ELISAs) were used to quantify interleukin-1β (IL-1β), tumor necrosis factor-α (TNF-α), matrix metalloproteinase-3 (MMP-3), and tissue inhibitor of metalloproteinase-1 (TIMP-1) levels in synovial fluid.
RESULTS


The platelet density in PRP was 5.13-times that in whole blood (P = .002). At 24 months, pain and function scores in the PRP+HA group were better than those in the HA and PRP alone groups (P pain  = .000; P function  = .000). At 6 and 12 months, synovial hyperplasia in the PRP and PRP+HA groups was improved (P < .05). After 6 and 12 months, the synovial peak systolic velocity (PSV), synovial end diastolic velocity (EDV), systolic/diastolic ratio (S/D) and resistance index (RI) were improved in the PRP+HA group (P < .05). Complications were highest in the PRP group (P = .008). After 6 and 12 months, IL-1β, TNF-α, MMP-3, and TIMP-1 in the PRP and PRP+HA groups decreased (P < .05), with more apparent inhibition in the PRP+HA group (P < .05).
CONCLUSIONS


PRP combined with HA is more effective than PRP or HA alone at inhibiting synovial inflammation and can effectively improve pain and function and reduce adverse reactions. Its mechanism involves changes in the synovium and cytokine content.",2020,"At 6 and 12 months, synovial hyperplasia in the PRP and PRP+HA groups was improved (P < .05).","['knee osteoarthritis (KOA', '122 knees were randomly divided into HA (34 knees), PRP (40 knees), and PRP+HA (48 knees) groups']","['PRP combined with HA', 'hyaluronic acid injection']","['pain and function scores', 'interleukin-1β (IL-1β), tumor necrosis factor-α (TNF-α), matrix metalloproteinase-3 (MMP-3), and tissue inhibitor of metalloproteinase-1 (TIMP-1) levels', 'synovial hyperplasia', 'WOMAC), Lysholm scores and postoperative complications', 'synovial peak systolic velocity (PSV), synovial end diastolic velocity (EDV), systolic/diastolic ratio (S/D) and resistance index (RI', 'Complications', 'pain and function and reduce adverse reactions', 'platelet density', 'Lequesne, Western Ontario and McMaster Universities Osteoarthritis Index', 'Visual Analogue Scale (VAS', 'IL-1β, TNF-α, MMP-3, and TIMP-1']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0032027', 'cui_str': 'Pityriasis rubra pilaris'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0032027', 'cui_str': 'Pityriasis rubra pilaris'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0164371', 'cui_str': 'Stromelysin 1'}, {'cui': 'C0145947', 'cui_str': 'Tissue inhibitor of metalloproteinases 1'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0020507', 'cui_str': 'Hyperplasia'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0442710', 'cui_str': 'Peak systolic'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0451868', 'cui_str': 'Localized osteoporosis - Lequesne'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",122.0,0.0190107,"At 6 and 12 months, synovial hyperplasia in the PRP and PRP+HA groups was improved (P < .05).","[{'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'Department of Orthopaedics, The Affiliated Hospital of Guizhou Medical University, Guiyang 550004, China; Key Laboratory of Adult Stem Cell Transformation Research, Chinese Academy of Medical Sciences, Guiyang 550004, China; National-Local Joint Engineering Laboratory of Cell Engineering and Biomedicine, Guiyang 550004, China; Center for Tissue Engineering and Stem Cell Research, Guizhou Medical University, Guiyang 550004, China.'}, {'ForeName': 'Zhixu', 'Initials': 'Z', 'LastName': 'He', 'Affiliation': 'Key Laboratory of Adult Stem Cell Transformation Research, Chinese Academy of Medical Sciences, Guiyang 550004, China.'}, {'ForeName': 'Liping', 'Initials': 'L', 'LastName': 'Shu', 'Affiliation': 'Key Laboratory of Adult Stem Cell Transformation Research, Chinese Academy of Medical Sciences, Guiyang 550004, China; National-Local Joint Engineering Laboratory of Cell Engineering and Biomedicine, Guiyang 550004, China; Center for Tissue Engineering and Stem Cell Research, Guizhou Medical University, Guiyang 550004, China.'}, {'ForeName': 'Xuanze', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Orthopaedics, The Affiliated Hospital of Guizhou Medical University, Guiyang 550004, China; Center for Tissue Engineering and Stem Cell Research, Guizhou Medical University, Guiyang 550004, China.'}, {'ForeName': 'Minxian', 'Initials': 'M', 'LastName': 'Ma', 'Affiliation': 'Key Laboratory of Adult Stem Cell Transformation Research, Chinese Academy of Medical Sciences, Guiyang 550004, China; National-Local Joint Engineering Laboratory of Cell Engineering and Biomedicine, Guiyang 550004, China; Center for Tissue Engineering and Stem Cell Research, Guizhou Medical University, Guiyang 550004, China.'}, {'ForeName': 'Chuan', 'Initials': 'C', 'LastName': 'Ye', 'Affiliation': 'Department of Orthopaedics, The Affiliated Hospital of Guizhou Medical University, Guiyang 550004, China; Key Laboratory of Adult Stem Cell Transformation Research, Chinese Academy of Medical Sciences, Guiyang 550004, China; National-Local Joint Engineering Laboratory of Cell Engineering and Biomedicine, Guiyang 550004, China; Center for Tissue Engineering and Stem Cell Research, Guizhou Medical University, Guiyang 550004, China; China Orthopaedic Regenerative Medicine Group (CORMed), Hangzhou 310000, China. Electronic address: yechuanchina@hotmail.com.'}]",Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association,['10.1016/j.arthro.2020.10.013']
2096,33091585,Identification of undiagnosed atrial fibrillation patients using a machine learning risk prediction algorithm and diagnostic testing (PULsE-AI): Study protocol for a randomised controlled trial.,"Atrial fibrillation (AF) is associated with an increased risk of stroke, enhanced stroke severity, and other comorbidities. However, AF is often asymptomatic, and frequently remains undiagnosed until complications occur. Current screening approaches for AF lack either cost-effectiveness or diagnostic sensitivity; thus, there is interest in tools that could be used for population screening. An AF risk prediction algorithm, developed using machine learning from a UK dataset of 2,994,837 patients, was found to be more effective than existing models at identifying patients at risk of AF. Therefore, the aim of the trial is to assess the effectiveness of this risk prediction algorithm combined with diagnostic testing for the identification of AF in a real-world primary care setting. Eligible participants (aged ≥30 years and without an existing AF diagnosis) registered at participating UK general practices will be randomised into intervention and control arms. Intervention arm participants identified at highest risk of developing AF (algorithm risk score ≥ 7.4%) will be invited for a 12‑lead electrocardiogram (ECG) followed by two-weeks of home-based ECG monitoring with a KardiaMobile device. Control arm participants will be used for comparison and will be managed routinely. The primary outcome is the number of AF diagnoses in the intervention arm compared with the control arm during the research window. If the trial is successful, there is potential for the risk prediction algorithm to be implemented throughout primary care for narrowing the population considered at highest risk for AF who could benefit from more intensive screening for AF. Trial Registration: NCT04045639.",2020,"An AF risk prediction algorithm, developed using machine learning from a UK dataset of 2,994,837 patients, was found to be more effective than existing models at identifying patients at risk of AF.","['Eligible participants (aged ≥30\u202fyears and without an existing AF diagnosis) registered at participating UK general practices', 'undiagnosed atrial fibrillation patients']","['12‑lead electrocardiogram (ECG) followed by two-weeks of home-based ECG monitoring with a KardiaMobile device', 'machine learning risk prediction algorithm and diagnostic testing (PULsE-AI']",['number of AF diagnoses'],"[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C4082118', 'cui_str': 'Two weeks'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]",,0.124353,"An AF risk prediction algorithm, developed using machine learning from a UK dataset of 2,994,837 patients, was found to be more effective than existing models at identifying patients at risk of AF.","[{'ForeName': 'Nathan R', 'Initials': 'NR', 'LastName': 'Hill', 'Affiliation': 'Bristol Myers Squibb Pharmaceutical Ltd, Uxbridge, UK. Electronic address: Nathan.Hill@bms.com.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Arden', 'Affiliation': 'Park Surgery, Chandlers Ford, Hampshire, UK. Electronic address: chrisarden@nhs.net.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Beresford-Hulme', 'Affiliation': 'Health Economics and Outcomes Research Ltd, Cardiff, UK. Electronic address: lee.beresfordhulme@heor.co.uk.'}, {'ForeName': 'A John', 'Initials': 'AJ', 'LastName': 'Camm', 'Affiliation': ""Cardiology Clinical Academic Group, Molecular & Clinical Sciences Research Institute, St. George's University of London, London, UK. Electronic address: jcamm@sgul.ac.uk.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Clifton', 'Affiliation': 'Institute of Biomedical Engineering, Department of Engineering Science, University of Oxford, UK. Electronic address: davidc@robots.ox.ac.uk.'}, {'ForeName': 'D Wyn', 'Initials': 'DW', 'LastName': 'Davies', 'Affiliation': ""St Mary's Hospital, London, UK.""}, {'ForeName': 'Usman', 'Initials': 'U', 'LastName': 'Farooqui', 'Affiliation': 'Bristol Myers Squibb Pharmaceutical Ltd, Uxbridge, UK. Electronic address: Usman.Farooqui@bms.com.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Gordon', 'Affiliation': 'Health Economics and Outcomes Research Ltd, Cardiff, UK. Electronic address: jason.gordon@heor.co.uk.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Groves', 'Affiliation': 'Health Economics and Outcomes Research Ltd, Cardiff, UK. Electronic address: lara.groves@heor.co.uk.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hurst', 'Affiliation': 'Health Economics and Outcomes Research Ltd, Cardiff, UK. Electronic address: michael.hurst@heor.co.uk.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Lawton', 'Affiliation': 'School of Medicine, Keele University, Staffordshire, UK. Electronic address: s.a.lawton@keele.ac.uk.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Lister', 'Affiliation': 'Bristol Myers Squibb Pharmaceutical Ltd, Uxbridge, UK. Electronic address: Steven.Lister@bms.com.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Mallen', 'Affiliation': 'School of Medicine, Keele University, Staffordshire, UK. Electronic address: c.d.mallen@keele.ac.uk.'}, {'ForeName': 'Anne-Celine', 'Initials': 'AC', 'LastName': 'Martin', 'Affiliation': 'Université de Paris, Innovative Therapies in Haemostasis, INSERM, Hôpital Européen Georges Pompidou, Service de Cardiologie, 20 rue Leblanc, Paris, France.'}, {'ForeName': 'Phil', 'Initials': 'P', 'LastName': 'McEwan', 'Affiliation': 'Health Economics and Outcomes Research Ltd, Cardiff, UK. Electronic address: phil.mcewan@heor.co.uk.'}, {'ForeName': 'Kevin G', 'Initials': 'KG', 'LastName': 'Pollock', 'Affiliation': 'Bristol Myers Squibb Pharmaceutical Ltd, Uxbridge, UK. Electronic address: Kevin.Pollock@bms.com.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Rogers', 'Affiliation': 'PHASTAR, London, UK. Electronic address: jennifer.rogers@phastar.com.'}, {'ForeName': 'Belinda', 'Initials': 'B', 'LastName': 'Sandler', 'Affiliation': 'Bristol Myers Squibb Pharmaceutical Ltd, Uxbridge, UK. Electronic address: Belinda.Sandler@bms.com.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Sugrue', 'Affiliation': 'Health Economics and Outcomes Research Ltd, Cardiff, UK. Electronic address: daniel.sugrue@heor.co.uk.'}, {'ForeName': 'Alexander T', 'Initials': 'AT', 'LastName': 'Cohen', 'Affiliation': ""Department of Haematological Medicine, Guys and St Thomas' NHS Foundation Trust, King's College London, London, UK. Electronic address: alexander.cohen@kcl.ac.uk.""}]",Contemporary clinical trials,['10.1016/j.cct.2020.106191']
2097,33091681,Concreteness of thoughts and images during suppression and expression of worry.,"The avoidance theory of worry (Borkovec, Alcaine, & Behar, 2004) posits that the verbal-linguistic (versus imagery-based) nature of worry elicits abstract (versus concrete) processing, which inhibits affective responding and generates a host of negative consequences. Although suppression of worrisome thinking is maladaptive (Purdon, 1999), expression of worry using vivid imagery may increase concreteness of worrisome thinking and facilitate more adaptive emotional responding. The present study examined whether the valence, content, and expression of mentation impacts concreteness of thought. Participants (N = 62) were randomly assigned to verbalize their thoughts while engaging in either verbal-linguistic- or imagery-based mentation about both worrisome and neutral topics. Participants were also randomly assigned to engage in a 5-min period of suppressing or expressing the target stimuli before engaging in 5-min of freely expressing the targets. Verbalizations of mental content were coded for level of abstractness/concreteness. For neutral stimuli, imagery-based mentation led to greater concreteness than did verbal-linguistic mentation; however, for worrisome stimuli, imagery-based mentation did not enhance concreteness. In addition, for neutral (but not worrisome) stimuli, an initial period of suppression was associated with increased concreteness during subsequent expression. Imagery-based mentation about worrisome stimuli may not enhance concreteness; moreover, unlike suppression of neutral stimuli, suppression of worrisome stimuli may maintain, rather than ameliorate, abstractness of thought.",2020,"For neutral stimuli, imagery-based mentation led to greater concreteness than did verbal-linguistic mentation; however, for worrisome stimuli, imagery-based mentation did not enhance concreteness.",['Participants (N\xa0=\xa062'],"['verbalize their thoughts while engaging in either verbal-linguistic- or imagery-based mentation about both worrisome and neutral topics', 'Imagery-based mentation about worrisome stimuli']",['Concreteness of thoughts and images during suppression and expression of worry'],[],"[{'cui': 'C0023741', 'cui_str': 'Linguistics'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1522168', 'cui_str': 'Topical route'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}]","[{'cui': 'C0039869', 'cui_str': 'Thinking'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0233481', 'cui_str': 'Worried'}]",62.0,0.0172364,"For neutral stimuli, imagery-based mentation led to greater concreteness than did verbal-linguistic mentation; however, for worrisome stimuli, imagery-based mentation did not enhance concreteness.","[{'ForeName': 'Alexander A', 'Initials': 'AA', 'LastName': 'Jendrusina', 'Affiliation': 'University of Illinois at Chicago, USA; VA Ann Arbor Healthcare System, USA. Electronic address: alexanderjendrusina@gmail.com.'}, {'ForeName': 'Elizabeth S', 'Initials': 'ES', 'LastName': 'Stevens', 'Affiliation': 'University of Illinois at Chicago, USA.'}, {'ForeName': 'Erica R', 'Initials': 'ER', 'LastName': 'Nahin', 'Affiliation': 'University of Miami, USA.'}, {'ForeName': 'Alison C', 'Initials': 'AC', 'LastName': 'Legrand', 'Affiliation': 'University of Vermont, USA.'}, {'ForeName': 'Evelyn', 'Initials': 'E', 'LastName': 'Behar', 'Affiliation': 'City University of New York - Hunter College, USA.'}]",Behaviour research and therapy,['10.1016/j.brat.2020.103754']
2098,33091687,Facial emotion recognition in borderline patients is unaffected by acute psychosocial stress.,"Borderline Personality Disorder (BPD) is characterized by difficulties in social cognition and social interactions, which exacerbate under stress. A previous study found better facial emotion recognition (FER) in patients with personality disorders and healthy controls (HC) after stress. We recently reported that emotional empathy scores, i.e. the emotional response to another person's emotional state, were significantly lower in BPD patients than in HC after psychosocial stress. Cognitive empathy scores remained unaltered. The present study aims to further investigate the effect of psychosocial stress induced by the Trier Social Stress Test (TSST) on FER as part of social cognition in patients with BPD. We randomized 43 women with BPD and 46 female HC to either the TSST or a placebo condition. Afterwards, participants were asked in an emotion recognition test to identify emotions in faces showing anger or sadness at low and high intensity. Both groups recognized emotions better at high intensity compared with low intensity. There was no effect of stress on FER performance and we found no difference between groups. This is in line with prior research on social cognition in BPD patients demonstrating that the ability to understand another person's perspective might be unaffected by acute stress.",2020,Cognitive empathy scores remained unaltered.,"['43 women with BPD and 46 female HC to either the TSST or a placebo condition', 'borderline patients', 'patients with personality disorders and healthy controls (HC) after stress', 'patients with BPD', 'Borderline Personality Disorder (BPD', 'BPD patients']",['Trier Social Stress Test (TSST'],"['Cognitive empathy scores', 'FER performance', 'Facial emotion recognition', 'facial emotion recognition (FER']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0006012', 'cui_str': 'Borderline personality disorder'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0065404', 'cui_str': 'lysyl-5-fluorotryptophyl-lysine'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031212', 'cui_str': 'Personality disorder'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]","[{'cui': 'C0065404', 'cui_str': 'lysyl-5-fluorotryptophyl-lysine'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}]","[{'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}]",43.0,0.0136793,Cognitive empathy scores remained unaltered.,"[{'ForeName': 'Livia', 'Initials': 'L', 'LastName': 'Graumann', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt Universität zu Berlin, Berlin Institute of Health (BIH), Klinik für Psychiatrie und Psychotherapie, Campus Benjamin Franklin, Berlin, Germany.'}, {'ForeName': 'Moritz', 'Initials': 'M', 'LastName': 'Duesenberg', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt Universität zu Berlin, Berlin Institute of Health (BIH), Klinik für Psychiatrie und Psychotherapie, Campus Benjamin Franklin, Berlin, Germany.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Metz', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt Universität zu Berlin, Berlin Institute of Health (BIH), Klinik für Psychiatrie und Psychotherapie, Campus Benjamin Franklin, Berlin, Germany.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Schulze', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Freie Universität Berlin, Germany.'}, {'ForeName': 'Oliver T', 'Initials': 'OT', 'LastName': 'Wolf', 'Affiliation': 'Institute of Cognitive Neuroscience, Department of Cognitive Psychology, Ruhr University Bochum, Bochum, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Roepke', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt Universität zu Berlin, Berlin Institute of Health (BIH), Klinik für Psychiatrie und Psychotherapie, Campus Benjamin Franklin, Berlin, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Otte', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt Universität zu Berlin, Berlin Institute of Health (BIH), Klinik für Psychiatrie und Psychotherapie, Campus Benjamin Franklin, Berlin, Germany.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Wingenfeld', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt Universität zu Berlin, Berlin Institute of Health (BIH), Klinik für Psychiatrie und Psychotherapie, Campus Benjamin Franklin, Berlin, Germany. Electronic address: katja.wingenfeld@charite.de.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.10.007']
2099,33091706,Methylene blue reduces incidence of early postoperative cognitive disorders in elderly patients undergoing major non-cardiac surgery: An open-label randomized controlled clinical trial.,"STUDY OBJECTIVE


The purpose of the present study was to investigate whether methylene blue (MB) could reduce the incidences of postoperative delirium (POD) and early postoperative cognitive dysfunction (POCD) in elderly patients undergoing major non-cardiac surgery.
DESIGN


Prospective, randomized, open-label clinical trial.
SETTING


University-affiliated hospital.
PATIENTS


Two hundred and forty-eight elderly patients scheduled for non-cardiac surgery.
INTERVENTIONS


Elderly patients undergoing non-cardiac major surgery were randomly assigned to MB group (n = 124), who receiving intravenous infusion of 2 mg/kg MB within 60 min immediately after anesthetic induction, or control group (n = 124), who receiving equal volume saline in the same way.
MEASUREMENTS


All patients were evaluated with delirium and neuropsychological batteries before and after surgery, as well as perioperative adverse events. Two plasma biomarkers superoxide dismutase (SOD) and homocysteine (HCY) were measured pre- and post-operatively.
MAIN RESULTS


There were total 39 cases(15.7%)experienced POD. The incidence of POD in MB group was significantly less than that in control group (7.3% vs. 24.2%, OR = 0.24, 95%CI: 0.11-0.53, p < 0.001). The incidence of early POCD at postoperative 7th day in MB group was also less than that in control group (16.1% vs. 40.2%, OR = 0.30, 95% CI: 0.16-0.57, p < 0.001). The adverse events were comparable in both groups. In addition, there was no significant correlation between POD/POCD and levels of SOD or HCY.
CONCLUSION


We conclude that intraoperative intravenous 2 mg/kg MB could significantly reduce the incidences of POD and early POCD in elderly surgical patients, while not remarkably increase incidence of perioperative adverse events, suggesting MB may be clinically effective and safe for prevention of early postoperative neurocognitive disorders.",2020,"Two plasma biomarkers superoxide dismutase (SOD) and homocysteine (HCY) were measured pre- and post-operatively.
","['Two hundred and forty-eight elderly patients scheduled for non-cardiac surgery', 'elderly patients undergoing major non-cardiac surgery', 'elderly surgical patients', 'University-affiliated hospital', 'Elderly patients undergoing non-cardiac major surgery']","['methylene blue (MB', 'Methylene blue', 'intravenous infusion of 2\xa0mg/kg\xa0MB within 60\xa0min immediately after anesthetic induction, or control group (n\xa0=\xa0124), who receiving equal volume saline', 'MB']","['POD/POCD and levels of SOD or HCY', 'incidences of POD and early POCD', 'incidence of early POCD', 'postoperative delirium (POD) and early postoperative cognitive dysfunction (POCD', 'incidence of POD', 'delirium and neuropsychological batteries', 'adverse events', 'perioperative adverse events', 'Two plasma biomarkers superoxide dismutase (SOD) and homocysteine (HCY', 'early postoperative cognitive disorders']","[{'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0025746', 'cui_str': 'Methylene blue'}, {'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0853212', 'cui_str': 'Induction of anaesthesia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C4721772', 'cui_str': 'Postoperative delirium'}, {'cui': 'C4721773', 'cui_str': 'Postoperative cognitive dysfunction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0019878', 'cui_str': 'Homocysteine'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0451331', 'cui_str': 'Neuropsychological battery'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0009241', 'cui_str': 'Cognitive disorder'}]",248.0,0.0572685,"Two plasma biomarkers superoxide dismutase (SOD) and homocysteine (HCY) were measured pre- and post-operatively.
","[{'ForeName': 'Yixu', 'Initials': 'Y', 'LastName': 'Deng', 'Affiliation': 'Department of Anesthesiology, Shanghai Cancer Center, Fudan University, Shanghai 200032, PR China.'}, {'ForeName': 'Ruijing', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Huashan Hospital, Fudan University, Shanghai 200040, PR China.'}, {'ForeName': 'Shitong', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, Huashan Hospital, Fudan University, Shanghai 200040, PR China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Department of Psychiatry, Huashan Hospital, Fudan University, Shanghai 200040, PR China.'}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Huashan Hospital, Fudan University, Shanghai 200040, PR China.'}, {'ForeName': 'Jianjun', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Neurology, Huashan Hospital, Fudan University, Shanghai 200040, PR China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, Shanghai Cancer Center, Fudan University, Shanghai 200032, PR China; Department of Oncology, Shanghai Medical College, Fudan University,Shanghai 200032, PR China. Electronic address: snapzhang@aliyun.com.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.110108']
2100,33091760,The social curse: Evidence for a moderating effect of shared social identity on contagious stress reactions.,"Contagious stress describes the transmission of a stress response from a distressed individual (target) to an uninvolved observer. Building on social identity theory, we hypothesize that a shared social identity between the observer and the target as compared to a personal identity increases the likelihood of contagious endocrine and psychological stress responses. Participants underwent the experiment in groups of four or five individuals. After experimentally inducing either a shared social identity or a personal identity, one participant in each group (N target  = 27) was randomly chosen to undergo the Trier Social Stress Test (TSST), while being observed by the rest of the group (N observer  = 89). Salivary cortisol and psychological stress responses were assessed repeatedly during the experiment. As predicted, the likelihood of cortisol stress reactions was significantly higher in the social identity condition (25 %) as compared to the personal identity condition (7 %). No effect of our manipulation on psychological stress responses was found. We also tested whether observers' trait empathy moderates contagious stress and found no support for this moderation.",2020,"As predicted, the likelihood of cortisol stress reactions was significantly higher in the social identity condition (25 %) as compared to the personal identity condition (7 %).",[],['Trier Social Stress Test (TSST'],"['Salivary cortisol and psychological stress responses', 'psychological stress responses', 'likelihood of cortisol stress reactions']",[],"[{'cui': 'C0065404', 'cui_str': 'lysyl-5-fluorotryptophyl-lysine'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}]","[{'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0038443', 'cui_str': 'Psychological Stress'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0016664', 'cui_str': 'Stress fracture'}]",,0.00992355,"As predicted, the likelihood of cortisol stress reactions was significantly higher in the social identity condition (25 %) as compared to the personal identity condition (7 %).","[{'ForeName': 'Valerie A', 'Initials': 'VA', 'LastName': 'Schury', 'Affiliation': 'Justus-Liebig-University Giessen, Germany. Electronic address: Valerie.A.Schury@psychol.uni-giessen.de.'}, {'ForeName': 'Urs M', 'Initials': 'UM', 'LastName': 'Nater', 'Affiliation': 'University of Vienna, Austria.'}, {'ForeName': 'Jan A', 'Initials': 'JA', 'LastName': 'Häusser', 'Affiliation': 'Justus-Liebig-University Giessen, Germany.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104896']
2101,33092219,Effects of an Activity Tracker and App Intervention to Increase Physical Activity in Whole Families-The Step It Up Family Feasibility Study.,"(1) Background: Interventions using activity trackers and smartphone apps have demonstrated their ability to increase physical activity in children and adults. However, they have not been tested in whole families. Further, few family-centered interventions have actively involved both parents and assessed physical activity effects separately for children, mothers and fathers. Objective: To examine the feasibility and short-term effects of an activity tracker and app intervention to increase physical activity in the whole family (children, mothers and fathers). (2) Methods: This was a single-arm feasibility study with pre-post intervention measures. Between 2017-2018, 40 families (58 children aged 6-10 years, 39 mothers, 33 fathers) participated in the 6-week  Step it Up Family  program in Queensland, Australia. Using commercial activity trackers combined with apps (Garmin Vivofit Jr for children, Vivofit 3 for adults; Garmin Australasia Pty Ltd., Sydney, Australia), the intervention included individual and family-level goal-setting, self-monitoring, performance feedback, family step challenges, family social support and modelling, weekly motivational text messages and an introductory session. Parent surveys were used to assess physical activity effects measured as pre-post intervention changes in moderate-to-vigorous physical activity (MVPA) in children, mothers and fathers. Objective Garmin activity tracker data was recorded to assess physical activity levels (steps, active minutes) during the intervention. (3) Results: Thirty-eight families completed the post intervention survey (95% retention). At post intervention, MVPA had increased in children by 58 min/day (boys: 54 min/day, girls: 62 min/day; all  p  < 0.001). In mothers, MVPA increased by 27 min/day ( p  < 0.001) and in fathers, it increased by 31 min/day ( p  < 0.001). The percentage of children meeting Australia's physical activity guidelines for children (≥60 MVPA min/day) increased from 34% to 89% ( p  < 0.001). The percentage of mothers and fathers meeting Australia's physical activity guidelines for adults (≥150 MVPA min/week) increased from 8% to 57% ( p  < 0.001) in mothers and from 21% to 68% ( p  < 0.001) in fathers. The percentage of families with 'at least one child and both parents' meeting the physical activity guidelines increased from 0% to 41% ( p  < 0.001). Objective activity tracker data recorded during the intervention showed that the mean ( SD ) number of active minutes per day in children was 82.1 (17.1). Further, the mean ( SD ) steps per day was 9590.7 (2425.3) in children, 7397.5 (1954.2) in mothers and 8161.7 (3370.3) in fathers. (4) Conclusions: Acknowledging the uncontrolled study design, the large pre-post changes in MVPA and rather high step counts recorded during the intervention suggest that an activity tracker and app intervention can increase physical activity in whole families. The  Step it Up Family  program warrants further efficacy testing in a larger, randomized controlled trial.",2020,"In mothers, MVPA increased by 27 min/day ( p  < 0.001) and in fathers, it increased by 31 min/day ( p  < 0.001).","['Whole Families', 'Between 2017-2018, 40 families (58 children aged 6-10 years, 39 mothers, 33 fathers) participated in the 6-week  Step it Up Family  program in Queensland, Australia', 'children, mothers and fathers', 'whole family (children, mothers and fathers', 'children and adults']","['Activity Tracker and App Intervention', 'commercial activity trackers combined with apps (Garmin Vivofit Jr', 'activity trackers and smartphone apps', 'activity tracker and app intervention']","['Objective Garmin activity tracker data', 'physical activity guidelines', 'mean ( SD ) number of active minutes', ""percentage of mothers and fathers meeting Australia's physical activity guidelines"", 'Physical Activity', 'physical activity effects', 'physical activity', 'moderate-to-vigorous physical activity (MVPA', 'physical activity levels (steps, active minutes', ""percentage of children meeting Australia's physical activity guidelines"", 'Objective activity tracker data', 'MVPA']","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0015671', 'cui_str': 'Father'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0454366', 'cui_str': 'Step ups'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C4264352', 'cui_str': 'Activity Trackers'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C4264352', 'cui_str': 'Activity Trackers'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0015671', 'cui_str': 'Father'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0680063', 'cui_str': 'Child of'}]",58.0,0.0336325,"In mothers, MVPA increased by 27 min/day ( p  < 0.001) and in fathers, it increased by 31 min/day ( p  < 0.001).","[{'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Schoeppe', 'Affiliation': 'Physical Activity Research Group, School of Health, Medical and Applied Sciences, Appleton Institute, Central Queensland University, Building 77, Bruce Highway, Rockhampton, QLD 4702, Australia.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Salmon', 'Affiliation': 'School of Exercise and Nutrition Sciences, Institute for Physical Activity and Nutrition (IPAN), Deakin University, 221 Burwood Highway, Burwood, Geelong, VIC 3125, Australia.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Williams', 'Affiliation': 'Physical Activity Research Group, School of Health, Medical and Applied Sciences, Appleton Institute, Central Queensland University, Building 77, Bruce Highway, Rockhampton, QLD 4702, Australia.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Power', 'Affiliation': 'Physical Activity Research Group, School of Health, Medical and Applied Sciences, Appleton Institute, Central Queensland University, Building 77, Bruce Highway, Rockhampton, QLD 4702, Australia.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Alley', 'Affiliation': 'Physical Activity Research Group, School of Health, Medical and Applied Sciences, Appleton Institute, Central Queensland University, Building 77, Bruce Highway, Rockhampton, QLD 4702, Australia.'}, {'ForeName': 'Amanda L', 'Initials': 'AL', 'LastName': 'Rebar', 'Affiliation': 'Physical Activity Research Group, School of Health, Medical and Applied Sciences, Appleton Institute, Central Queensland University, Building 77, Bruce Highway, Rockhampton, QLD 4702, Australia.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Hayman', 'Affiliation': 'Physical Activity Research Group, School of Health, Medical and Applied Sciences, Appleton Institute, Central Queensland University, Building 77, Bruce Highway, Rockhampton, QLD 4702, Australia.'}, {'ForeName': 'Mitch J', 'Initials': 'MJ', 'LastName': 'Duncan', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, School of Medicine & Public Health, Faculty of Health and Medicine, The University of Newcastle, University Drive, Callaghan, Newcastle, NSW 2308, Australia.'}, {'ForeName': 'Corneel', 'Initials': 'C', 'LastName': 'Vandelanotte', 'Affiliation': 'Physical Activity Research Group, School of Health, Medical and Applied Sciences, Appleton Institute, Central Queensland University, Building 77, Bruce Highway, Rockhampton, QLD 4702, Australia.'}]",International journal of environmental research and public health,['10.3390/ijerph17207655']
2102,33092241,Electroacupuncture and Manual Acupuncture Increase Joint Flexibility but Reduce Muscle Strength.,"The objective of this study was to investigate the immediate effects of electroacupuncture and manual acupuncture on hip flexion range of motion (ROM), knee joint (flexion replication at 15° and 45°) and quadriceps (strength and activation) function. Forty-five neurologically healthy adults participated in this randomized controlled laboratory study. Straight leg raise test, modified Thomas test, and hip abductors strength test were performed to determine acupoints. Afterwards, one of three 15-min treatments (control-no treatment, electroacupuncture, or manual acupuncture) was randomly applied using determined acupoints. Measurements (hip flexion ROM, and knee joint and quadriceps function) were recorded at baseline, and at 0, 20, and 40 min post treatment. Both electroacupuncture (4.0°, ES = 0.41) and manual acupuncture (5.4°, ES = 0.95) treatment immediately increased hip flexion ROM, and the increased values persisted for 40-min ( p  = 0.01). Knee flexion replication (at 15°:  p  = 0.17; 45°:  p  = 0.19) and quadriceps activation ( p  = 0.71) did not change at any of the time points. Post-treatment, both electroacupuncture and manual acupuncture decreased quadriceps strength at 0-min (electroacupuncture: 9.2%,  p  < 0.0001, ES = 0.60) and 40-min (electroacupuncture: 7.3%,  p  = 0.005, ES = 0.55; manual acupuncture: 8.7%,  p  = 0.01, ES = 0.54). A single session of either electroacupuncture or manual acupuncture treatment (selected acupoints based on physical examination) may immediately improve joint flexibility but reduce muscle strength.",2020,Knee flexion replication (at 15°:  p  = 0.17; 45°:  p  = 0.19) and quadriceps activation ( p  = 0.71) did not change at any of the time points.,['Forty-five neurologically healthy adults'],"['electroacupuncture, or manual acupuncture', 'electroacupuncture', 'electroacupuncture and manual acupuncture', 'electroacupuncture or manual acupuncture treatment (selected acupoints based on physical examination', 'manual acupuncture', 'Electroacupuncture and Manual Acupuncture', '0-min (electroacupuncture']","['hip flexion range of motion (ROM), knee joint (flexion replication at 15° and 45°) and quadriceps (strength and activation) function', 'quadriceps activation', 'quadriceps strength', 'Measurements (hip flexion ROM, and knee joint and quadriceps function', 'hip flexion ROM', 'Knee flexion replication']","[{'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0394664', 'cui_str': 'Acupuncture'}, {'cui': 'C0001302', 'cui_str': 'Acupuncture point'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0439232', 'cui_str': 'min'}]","[{'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0022745', 'cui_str': 'Knee joint structure'}, {'cui': 'C0598312', 'cui_str': 'DNA replication'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}]",45.0,0.0463621,Knee flexion replication (at 15°:  p  = 0.17; 45°:  p  = 0.19) and quadriceps activation ( p  = 0.71) did not change at any of the time points.,"[{'ForeName': 'Daeho', 'Initials': 'D', 'LastName': 'Kim', 'Affiliation': 'Department of Sports Science and Rehabilitation, Woosong University, Daejeon 34606, Korea.'}, {'ForeName': 'Sein', 'Initials': 'S', 'LastName': 'Jang', 'Affiliation': 'Bareun Korean Medicine Clinic, Seoul 05616, Korea.'}, {'ForeName': 'Jihong', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': 'Department of Sports Medicine, Athletic Training Laboratory, Kyung Hee University, Yongin 17104, Korea.'}]","Healthcare (Basel, Switzerland)",['10.3390/healthcare8040414']
2103,33092315,Comparing the postoperative outcomes of single incision laparoscopic appendectomy and three port appendectomy with enhanced recovery after surgery protocol for acute appendicitis: A propensity score matching analysis.,"Purpose


The objective of this study was to compare the perioperative outcomes between single incision laparoscopic appendectomy (SILA) and three port appendectomy (CLA) in enhanced recovery after surgery (ERAS) protocol.
Methods


Of 101 laparoscopic appendectomy with ERAS protocol cases for appendicitis from March 2019 to April 2020, 54 patients underwent SILA with multimodal analgesic approach (group 1) while 47 patients received CLA with multimodal analgesic approach (group 2). SILA and CLA were compared with the single institution's ERAS protocol. To adjust for baseline differences and selection bias, operative outcomes and complications were compared after propensity score matching (PSM).
Results


After 1:1 PSM, well-matched 35 patients in each group were evaluated. Postoperative hospital stays for patients in group 1 (1.2±0.8 vs. 1.6±0.8 days, p =0.037) were significantly lesser than those for patients in group 2. However, opioid consumption (2.0 mg vs. 1.4 mg, p =0.1) and the postoperative visual analogue scores for pain at 6 hours (2.4±1.9 vs. 2.8±1.4, p = 0.260) and 12 hours (2.4±2.0 vs. 2.9±1.5, p=0.257) did not show significant difference between the two groups.
Conclusion


SILA resulted in shortening the length of hospitalization without increase in complications or readmission rates compared to CLA with ERAS protocol.",2020,"However, opioid consumption (2.0 mg vs. 1.4 mg, p =0.1) and the postoperative visual analogue scores for pain at 6 hours (2.4±1.9 vs. 2.8±1.4, p = 0.260) and 12 hours (2.4±2.0 vs. 2.9±1.5, p=0.257) did not show significant difference between the two groups.
","['54 patients underwent', '101 laparoscopic appendectomy with ERAS protocol cases for appendicitis from March 2019 to April 2020', 'acute appendicitis']","['single incision laparoscopic appendectomy (SILA) and three port appendectomy (CLA', 'single incision laparoscopic appendectomy and three port appendectomy', 'SILA with multimodal analgesic approach', 'CLA with multimodal analgesic approach']","['shortening the length of hospitalization', 'Postoperative hospital stays', 'opioid consumption', 'complications or readmission rates', 'postoperative visual analogue scores for pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0372525', 'cui_str': 'Laparoscopic appendectomy'}, {'cui': 'C5197734', 'cui_str': 'Enhanced Postsurgical Recovery'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0003615', 'cui_str': 'Appendicitis'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0372525', 'cui_str': 'Laparoscopic appendectomy'}, {'cui': 'C0452253', 'cui_str': 'Port'}, {'cui': 'C0003611', 'cui_str': 'Appendectomy'}, {'cui': 'C0050156', 'cui_str': '9,11-linoleic acid'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0441636', 'cui_str': 'Surgical shortening - action'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.0554726,"However, opioid consumption (2.0 mg vs. 1.4 mg, p =0.1) and the postoperative visual analogue scores for pain at 6 hours (2.4±1.9 vs. 2.8±1.4, p = 0.260) and 12 hours (2.4±2.0 vs. 2.9±1.5, p=0.257) did not show significant difference between the two groups.
","[{'ForeName': 'Won Jong', 'Initials': 'WJ', 'LastName': 'Kim', 'Affiliation': ""Department of Surgery, College of Medicine, Seoul St. Mary's Hospital, the Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Hyeong Yong', 'Initials': 'HY', 'LastName': 'Jin', 'Affiliation': ""Department of Surgery, College of Medicine, Seoul St. Mary's Hospital, the Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Hyojin', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': ""Department of Surgery, College of Medicine, Seoul St. Mary's Hospital, the Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Jung Hoon', 'Initials': 'JH', 'LastName': 'Bae', 'Affiliation': ""Department of Surgery, College of Medicine, Seoul St. Mary's Hospital, the Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Wooree', 'Initials': 'W', 'LastName': 'Koh', 'Affiliation': 'Department of Surgery, Hansol Hospital, Seoul, Korea.'}, {'ForeName': 'Ji Yeon', 'Initials': 'JY', 'LastName': 'Mun', 'Affiliation': ""Department of Surgery, College of Medicine, Seoul St. Mary's Hospital, the Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Hee Ju', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': ""Department of Surgery, College of Medicine, Seoul St. Mary's Hospital, the Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'In Kyu', 'Initials': 'IK', 'LastName': 'Lee', 'Affiliation': ""Department of Surgery, College of Medicine, Seoul St. Mary's Hospital, the Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Yoon Suk', 'Initials': 'YS', 'LastName': 'Lee', 'Affiliation': ""Department of Surgery, College of Medicine, Seoul St. Mary's Hospital, the Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Chul Seung', 'Initials': 'CS', 'LastName': 'Lee', 'Affiliation': ""Department of Surgery, College of Medicine, Seoul St. Mary's Hospital, the Catholic University of Korea, Seoul, Republic of Korea.""}]",Annals of coloproctology,['10.3393/ac.2020.09.15']
2104,33092320,Acute carnosine and β-alanine supplementation increases the compensated part of the ventilation vs work rate relationship during a ramp incremental cycle test in physically active men.,"BACKGROUND


Chronic supplementation with carnosine and β-alanine (Carn-βA) has been proposed to improve muscle contractility and reduce muscle fatigue mainly through an increase in intracellular pH buffering capacity. However, the acute ergogenic effects of Carn-βA supplementation are poorly investigated. This study aimed at evaluating the acute effects of a single Carn-βA supplementation on the cardiorespiratory and metabolic response during a ramp cycle-ergometric test.
METHODS


This randomized, double-blind, placebo-controlled study, involved 10 healthy males (age 22.2±1.9 years, body mass 72.5±7.9 kg, stature 1.72±0.08 m, body mass index, 24.47±1.91 kg/m2, mean±standard deviation). All the participants performed two maximal incremental ramp tests on a cycle ergometer, with a prior randomized assumption of 2.5 g L-carnosine plus 2.5 g β-alanine (Carn-βA) or placebo (PLA). During exercise, gas exchange parameters were measured breath-by-breath, heart rate was monitored by electrocardiography and rate perceived exertion was determined on Borg scales. From the ramp test, peak cardiorespiratory and metabolic parameters and ventilatory thresholds (VT1 and VT2) were calculated off-line.
RESULTS


No differences between the experimental conditions emerged at peak exercise. However, despite acute Carn-ßA supplementation did not affect the single ventilatory thresholds, the compensated portion of the ramp test (i.e., the difference between VT2 and VT1) was significantly larger (P= 0.043) in Carn-ßA.
CONCLUSIONS


These findings demonstrate a positive effect of acute Carn-ßA supplementation on the compensated part of the exercise. This should be taken into account by nutritionists and athletes searching for nutritional supplements, when a quick effect based on an acute dose is required.",2020,"From the ramp test, peak cardiorespiratory and metabolic parameters and ventilatory thresholds (VT1 and VT2) were calculated off-line.
","['10 healthy males (age 22.2±1.9 years, body mass 72.5±7.9 kg, stature 1.72±0.08 m, body mass index, 24.47±1.91 kg/m2, mean±standard deviation', 'physically active men']","['carnosine and β-alanine (Carn-βA', 'carnosine plus 2.5 g β-alanine (Carn-βA) or placebo (PLA', 'single Carn-βA supplementation', 'placebo', 'β-alanine supplementation']","['peak cardiorespiratory and metabolic parameters and ventilatory thresholds (VT1 and VT2', 'cardiorespiratory and metabolic response', 'breath-by-breath, heart rate']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0556453', 'cui_str': 'Physically active'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0007267', 'cui_str': 'Carnosine'}, {'cui': 'C0001898', 'cui_str': 'Alanine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0225386', 'cui_str': 'Breath'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",10.0,0.214535,"From the ramp test, peak cardiorespiratory and metabolic parameters and ventilatory thresholds (VT1 and VT2) were calculated off-line.
","[{'ForeName': 'Eloisa', 'Initials': 'E', 'LastName': 'Limonta', 'Affiliation': 'Department of Biomedical Sciences for Health, Università degli Studi di Milano, Milan, Italy - eloisa.limonta@unimi.it.'}, {'ForeName': 'Pietro L', 'Initials': 'PL', 'LastName': 'Invernizzi', 'Affiliation': 'Department of Biomedical Sciences for Health, Università degli Studi di Milano, Milan, Italy.'}, {'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Rampichini', 'Affiliation': 'Department of Biomedical Sciences for Health, Università degli Studi di Milano, Milan, Italy.'}, {'ForeName': 'Angela V', 'Initials': 'AV', 'LastName': 'Bisconti', 'Affiliation': 'Department of Biomedical Sciences for Health, Università degli Studi di Milano, Milan, Italy.'}, {'ForeName': 'Emiliano', 'Initials': 'E', 'LastName': 'CÉ', 'Affiliation': 'Department of Biomedical Sciences for Health, Università degli Studi di Milano, Milan, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Longo', 'Affiliation': 'Department of Biomedical Sciences for Health, Università degli Studi di Milano, Milan, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Coratella', 'Affiliation': 'Department of Biomedical Sciences for Health, Università degli Studi di Milano, Milan, Italy.'}, {'ForeName': 'Marcello F', 'Initials': 'MF', 'LastName': 'Iaia', 'Affiliation': 'Department of Biomedical Sciences for Health, Università degli Studi di Milano, Milan, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Esposito', 'Affiliation': 'Department of Biomedical Sciences for Health, Università degli Studi di Milano, Milan, Italy.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.20.10887-9']
2105,33094725,A randomized controlled trial of oxygen therapy for patients who do not respond to upper airway surgery for obstructive sleep apnea.,"STUDY OBJECTIVES


We aimed to determine if patients diagnosed with obstructive sleep apnea (OSA) who fail to respond to upper airway surgery may be successfully treated with supplemental oxygen and if we could identify baseline physiological endotypes (i.e. collapsibility, loop gain, arousal threshold and muscle compensation) that predict response to oxygen therapy.
METHODS


We conducted a single night, randomized double blinded cross over trial in which OSA patients who failed to respond to upper airway surgery were treated on separate nights with oxygen therapy (4 L/min) or placebo (medical air). Effect of oxygen/air on OSA on key polysomnography (PSG) outcomes were assessed: apnea-hypopnea index (AHI), AHI without desaturation (i.e. flow-based AHI [AHI fb ]), arousal index and morning blood pressure. OSA endotypes were estimated from the PSG signals to determine whether baseline OSA physiology could be used to predict response to oxygen therapy.
RESULTS


There was a statistically significant reduction in AHI and AHI fb  on oxygen versus placebo (AHI fb:  42.4±21.5 vs. 30.5±17.1 events/h, p = 0.008). Arousal index was also reduced on oxygen versus placebo (41.1±19.5 versus 33.0±15.3 events/h, p = 0.006). There was no significant difference in morning blood pressure between oxygen and placebo. While 7/20 subjects experienced a 50% reduction or greater in AHI fb  on oxygen (responders), there was no difference in the baseline OSA endotypes (or clinical characteristics) between responders and non-responders.
CONCLUSIONS


Our findings demonstrate that a proportion of patients who fail to respond to upper airway surgery for OSA respond acutely to treatment with supplemental oxygen.
CLINICAL TRIAL REGISTRATION


Registry: Australian New Zealand Clinical Trials Registry; title: Oxygen therapy for treating patients with residual obstructive sleep apnoea following upper airway surgery; identifier: ACTRN12617001361392; URL: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=373566.",2020,"There was a statistically significant reduction in AHI and AHI fb  on oxygen versus placebo (AHI fb:  42.4±21.5 vs. 30.5±17.1 events/h, p = 0.008).","['patients diagnosed with obstructive sleep apnea (OSA) who fail to respond to upper airway surgery', 'patients who do not respond to upper airway surgery for obstructive sleep apnea', 'OSA patients who failed to respond to upper airway surgery', 'patients with residual obstructive sleep apnoea following upper airway surgery']","['placebo', 'oxygen therapy', 'oxygen therapy (4 L/min) or placebo (medical air', 'oxygen/air on OSA']","['apnea-hypopnea index (AHI), AHI without desaturation (i.e. flow-based AHI [AHI fb ]), arousal index and morning blood pressure', 'baseline OSA endotypes', 'AHI and AHI fb  on oxygen', 'morning blood pressure', 'Arousal index']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0225377', 'cui_str': 'Structure of upper respiratory tract cavity'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}, {'cui': 'C0439393', 'cui_str': 'L/min'}, {'cui': 'C3536832', 'cui_str': 'Air'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}]","[{'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}]",,0.349102,"There was a statistically significant reduction in AHI and AHI fb  on oxygen versus placebo (AHI fb:  42.4±21.5 vs. 30.5±17.1 events/h, p = 0.008).","[{'ForeName': 'Simon A', 'Initials': 'SA', 'LastName': 'Joosten', 'Affiliation': 'Monash Lung and Sleep, Monash Medical Centre, Clayton, Victoria, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Tan', 'Affiliation': 'Monash Lung and Sleep, Monash Medical Centre, Clayton, Victoria, Australia.'}, {'ForeName': 'Ai-Ming', 'Initials': 'AM', 'LastName': 'Wong', 'Affiliation': 'Monash Lung and Sleep, Monash Medical Centre, Clayton, Victoria, Australia.'}, {'ForeName': 'Shane A', 'Initials': 'SA', 'LastName': 'Landry', 'Affiliation': 'Department of Physiology, School of Biomedical Sciences and Biomedical Discovery Institute, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Leong', 'Affiliation': 'Monash Lung and Sleep, Monash Medical Centre, Clayton, Victoria, Australia.'}, {'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'Sands', 'Affiliation': ""Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham & Women's Hospital & Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Beatty', 'Affiliation': 'Department of Physiology, School of Biomedical Sciences and Biomedical Discovery Institute, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Thomson', 'Affiliation': 'Department of Physiology, School of Biomedical Sciences and Biomedical Discovery Institute, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Stonehouse', 'Affiliation': 'Monash Lung and Sleep, Monash Medical Centre, Clayton, Victoria, Australia.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Turton', 'Affiliation': 'Monash Lung and Sleep, Monash Medical Centre, Clayton, Victoria, Australia.'}, {'ForeName': 'Garun S', 'Initials': 'GS', 'LastName': 'Hamilton', 'Affiliation': 'Monash Lung and Sleep, Monash Medical Centre, Clayton, Victoria, Australia.'}, {'ForeName': 'Bradley A', 'Initials': 'BA', 'LastName': 'Edwards', 'Affiliation': 'Department of Physiology, School of Biomedical Sciences and Biomedical Discovery Institute, Monash University, Melbourne, Victoria, Australia.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.8920']
2106,33094728,Effects of empagliflozin on proinflammatory cytokines and other coronary risk factors in patients with type 2 diabetes mellitus: A single-arm real-world observation.,"OBJECTIVE


This single-arm real-world observation aims to examine the effects of empagliflozin (EMPA) on coronary risk factors among subjects with known diabetes.
MATERIALS AND METHODS


Records of 63 subjects with type 2 diabetes mellitus, receiving EMPA were drawn for this study. Of 63 patients with diabetes, 6 were excluded, and the remaining 57 received EMPA (25 mg/day) for 24 weeks. Clinical data, dietary intakes, and physical activity were assessed by validated questionnaires.
RESULTS


Treatment with EMPA was associated with significant decline in fasting and 2-hour post-prandial blood glucose and Hb1c indicating that this agent has potential antidiabetic effects. Pro-inflammatory cytokines; C-reactive protein, TNF-α, and interleukin-6 showed significant reduction after treatment with EMPA, compared to baseline levels. Apart from these changes, parameters of oxidative stress, thiobarbituric acid reactive substances, malondialdehyde, and diene conjugates as well as uric acid, showed a significant decline with an increase in antioxidant vitamins A, E, and C and beta-carotene as well as nitrite. There was a significant decline in serum uric acid, systolic and diastolic blood pressures, and angiotensin-converting enzyme (ACE), with a non-significant reduction in body weight and body mass index as well as in waist circumference of modest significance, after intervention of 12 weeks compared to baseline levels. Total cholesterol, VLDL cholesterol and triglycerides showed non-significant decline compared to baseline levels.
CONCLUSION


It is possible that EMPA administration can cause a significant decline in pro-inflammatory cytokines along with blood glucose, Hb1c, oxidative stress, uric acid, blood pressures, and ACE with an increase in antioxidant vitamins and nitrite. Randomized, controlled intervention trials would be necessary to confirm our findings.",2020,"Pro-inflammatory cytokines; C-reactive protein, TNF-α, and interleukin-6 showed significant reduction after treatment with EMPA, compared to baseline levels.","['patients with type 2 diabetes mellitus', 'Records of 63 subjects with type 2 diabetes mellitus, receiving EMPA were drawn for this study', 'subjects with known diabetes', '63 patients with diabetes']","['EMPA', 'empagliflozin', 'empagliflozin (EMPA']","['serum uric acid, systolic and diastolic blood pressures, and angiotensin-converting enzyme (ACE', 'coronary risk factors', 'Total cholesterol, VLDL cholesterol and triglycerides', 'fasting and 2-hour post-prandial blood glucose', 'body weight and body mass index', 'oxidative stress, thiobarbituric acid reactive substances, malondialdehyde, and diene conjugates', 'Clinical data, dietary intakes, and physical activity', 'antioxidant vitamins A, E, and C and beta-carotene', 'proinflammatory cytokines and other coronary risk factors']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C2355580', 'cui_str': 'Record of'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0013113', 'cui_str': 'Drawings'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205309', 'cui_str': 'Known'}]","[{'cui': 'C3490348', 'cui_str': 'empagliflozin'}]","[{'cui': 'C0455272', 'cui_str': 'Serum urate measurement'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0022709', 'cui_str': 'Dipeptidyl carboxypeptidase I'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023826', 'cui_str': 'VLDL cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C1292425', 'cui_str': '2 hours'}, {'cui': 'C0428569', 'cui_str': 'Post-prandial blood glucose measurement'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0162781', 'cui_str': 'TBARs'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0301869', 'cui_str': 'Conjugate'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C0053396', 'cui_str': 'Beta Carotene'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}]",63.0,0.0443367,"Pro-inflammatory cytokines; C-reactive protein, TNF-α, and interleukin-6 showed significant reduction after treatment with EMPA, compared to baseline levels.","[{'ForeName': 'Ram B', 'Initials': 'RB', 'LastName': 'Singh', 'Affiliation': ''}, {'ForeName': 'Ghizal', 'Initials': 'G', 'LastName': 'Fatima', 'Affiliation': ''}, {'ForeName': 'Puneet', 'Initials': 'P', 'LastName': 'Kumar', 'Affiliation': ''}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Fedacko', 'Affiliation': ''}, {'ForeName': 'Viliam', 'Initials': 'V', 'LastName': 'Mojto', 'Affiliation': ''}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Isaza', 'Affiliation': ''}, {'ForeName': 'Nar', 'Initials': 'N', 'LastName': 'SinghVerma', 'Affiliation': ''}, {'ForeName': 'Anuj', 'Initials': 'A', 'LastName': 'Maheshwari', 'Affiliation': ''}, {'ForeName': 'Shashank', 'Initials': 'S', 'LastName': 'Joshi', 'Affiliation': ''}, {'ForeName': 'Banshi', 'Initials': 'B', 'LastName': 'Saboo', 'Affiliation': ''}, {'ForeName': 'Manoj', 'Initials': 'M', 'LastName': 'Saxena', 'Affiliation': ''}]",International journal of clinical pharmacology and therapeutics,['10.5414/CP203787']
2107,31196678,An Update on Regenerative Medicine Clinical Trials in Erectile Dysfunction: Have We Made Any Progress?,"Regenerative cell-based therapy for erectile dysfunction is probably safe, and may be functionally beneficial. Currently, phase 2 trials are under way that we hope will provide a better insight into the efficacy of this regenerative therapy.",2019,"Currently, phase 2 trials are under way that we hope will provide a better insight into the efficacy of this regenerative therapy.",['Erectile Dysfunction'],['Regenerative cell-based therapy'],[],"[{'cui': 'C0242350', 'cui_str': 'Impotence'}]","[{'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]",[],,0.0537074,"Currently, phase 2 trials are under way that we hope will provide a better insight into the efficacy of this regenerative therapy.","[{'ForeName': 'Mohit', 'Initials': 'M', 'LastName': 'Khera', 'Affiliation': 'Baylor College of Medicine, Houston, TX, USA. Electronic address: mkhera@bcm.edu.'}, {'ForeName': 'Trinity', 'Initials': 'T', 'LastName': 'Bivalacqua', 'Affiliation': 'The James Buchanan Brady Urological Institute, Johns Hopkins Hospital, Baltimore, MD, USA.'}, {'ForeName': 'Irwin', 'Initials': 'I', 'LastName': 'Goldstein', 'Affiliation': 'Sexual Medicine, Alvarado Hospital, San Diego, CA, USA.'}, {'ForeName': 'Maarten', 'Initials': 'M', 'LastName': 'Albersen', 'Affiliation': 'Laboratory of Experimental Urology, Department of Development and Regeneration, Leuven University, Leuven, Belgium; Department of Urology, University Hospitals Leuven, Leuven, Belgium.'}]",European urology focus,['10.1016/j.euf.2019.05.017']
2108,31351909,A randomized controlled 10 years follow up of a glass ionomer restorative material in class I and class II cavities.,"OBJECTIVE


To evaluate the durability of a glass ionomer restorative material in Class I and Class II cavities during 10 years compared with a micro filled composite resin.
METHODS


Fifty-nine participants (mean age 24 years) received 140 (80 Class I and 60 Class II) glass ionomer (GI) or composite resin (CR) restorations. Evaluation was performed with slightly modified USPHS criteria at baseline, and yearly during the 10 years. Data were analyzed with Cohran's Q and McNemar's tests.
RESULTS


Fifty-one patients and 124 restorations (61 GI / 38 Class I - 23 Class II, 63 CR / 38 Class I, 25 Class II) were evaluated after 10 years. The recall rate was 86.4%. The overall clinical recall rate of restorations was 88.6%. The success rate of Class I and II restorations were calculated as 100% for both materials. The cumulative failure rate (CRF) of all Cl I and Cl II GI restorations was 3.17% in total, but CFR was 8 % for Cl II GI restorations. A significant difference was observed between the marginal discoloration scores of restorations at 10 years (p = 0.022). No significant difference was seen between two restorative materials in terms of marginal adaptation (p > 0.05). A significant change was seen in color match of GI restorations at 10 years (p < 0.05). No significant change was found for the anatomical form, secondary caries, postoperative sensitivity, surface texture, and retention for either restorative material (p > 0.05).
CONCLUSIONS


Both tested restorative materials showed an acceptable success rate in the restoration of Class I and Class II cavities during the 10-year follow up.",2020,"No significant change was found for the anatomical form, secondary caries, postoperative sensitivity, surface texture, and retention for either restorative material (p > 0.05).
","['Fifty-nine participants (mean age 24 years) received 140 (80 Class I and 60 Class II) glass ionomer (GI) or composite resin (CR) restorations', 'Class I and Class II cavities during 10 years compared with a micro filled composite resin']",['glass ionomer restorative material in class'],"['marginal adaptation', 'color match of GI restorations', 'overall clinical recall rate of restorations', 'success rate of Class I and II restorations', 'recall rate', 'marginal discoloration scores of restorations', 'cumulative failure rate (CRF) of all Cl I and Cl II GI restorations', 'anatomical form, secondary caries, postoperative sensitivity, surface texture, and retention for either restorative material']","[{'cui': 'C3830128', 'cui_str': '59'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0441885', 'cui_str': 'Class 1'}, {'cui': 'C0441886', 'cui_str': 'Class 2'}, {'cui': 'C0061297', 'cui_str': 'glass ionomer'}, {'cui': 'C0009570', 'cui_str': 'Composite Resins'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0085672', 'cui_str': 'Microbiology procedure'}]","[{'cui': 'C0061297', 'cui_str': 'glass ionomer'}, {'cui': 'C0182981', 'cui_str': 'Dental restorative material'}, {'cui': 'C0456387', 'cui_str': 'Class'}]","[{'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0061297', 'cui_str': 'glass ionomer'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0441885', 'cui_str': 'Class 1'}, {'cui': 'C0332572', 'cui_str': 'Abnormal color'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C1882989', 'cui_str': 'Secondary caries'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0449582', 'cui_str': 'With texture'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0182981', 'cui_str': 'Dental restorative material'}]",59.0,0.0204612,"No significant change was found for the anatomical form, secondary caries, postoperative sensitivity, surface texture, and retention for either restorative material (p > 0.05).
","[{'ForeName': 'Sevil', 'Initials': 'S', 'LastName': 'Gurgan', 'Affiliation': 'Hacettepe University, Faculty of Dentistry, Department of Restorative Dentistry, Sıhhiye, Ankara Turkey.'}, {'ForeName': 'Zeynep Bilge', 'Initials': 'ZB', 'LastName': 'Kutuk', 'Affiliation': 'Hacettepe University, Faculty of Dentistry, Department of Restorative Dentistry, Sıhhiye, Ankara Turkey. Electronic address: zeynepbilge.kutuk@hacettepe.edu.tr.'}, {'ForeName': 'Filiz', 'Initials': 'F', 'LastName': 'Yalcin Cakir', 'Affiliation': 'Hacettepe University, Faculty of Dentistry, Department of Restorative Dentistry, Sıhhiye, Ankara Turkey.'}, {'ForeName': 'Esra', 'Initials': 'E', 'LastName': 'Ergin', 'Affiliation': 'Hacettepe University, Faculty of Dentistry, Department of Restorative Dentistry, Sıhhiye, Ankara Turkey.'}]",Journal of dentistry,['10.1016/j.jdent.2019.07.013']
2109,31452011,A cadaver pilot study to evaluate the impact of the needle bevel orientation on the ease of paravertebral catheter insertion.,,2019,,[],['needle bevel orientation'],[],[],"[{'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0029266', 'cui_str': 'Orientation'}]",[],,0.0160887,,"[{'ForeName': 'Maxim', 'Initials': 'M', 'LastName': 'Roy', 'Affiliation': ""Department of Anesthesiology, Centre Hospitalier de l'Université de Montréal (CHUM), Montreal, QC, Canada. maxim.roy20@gmail.com.""}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Robin', 'Affiliation': ""Department of Anesthesiology, Centre Hospitalier de l'Université de Montréal (CHUM), Montreal, QC, Canada.""}, {'ForeName': 'Detlev', 'Initials': 'D', 'LastName': 'Grabs', 'Affiliation': 'Department of Anatomy, Université du Québec à Trois-Rivières (UQTR), Trois-Rivières, QC, Canada.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Letourneau-Guillon', 'Affiliation': ""Department of Radiology, Centre Hospitalier de l'Université de Montréal (CHUM), Montreal, QC, Canada.""}, {'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'Ruel', 'Affiliation': ""Department of Anesthesiology, Centre Hospitalier de l'Université de Montréal (CHUM), Montreal, QC, Canada.""}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Girard', 'Affiliation': ""Department of Anesthesiology, Centre Hospitalier de l'Université de Montréal (CHUM), Montreal, QC, Canada.""}, {'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Garneau', 'Affiliation': ""Department of Anesthesiology, Centre Hospitalier de l'Université de Montréal (CHUM), Montreal, QC, Canada.""}]",Canadian journal of anaesthesia = Journal canadien d'anesthesie,['10.1007/s12630-019-01468-8']
2110,31504399,Estimating individual lifetime benefit and bleeding risk of adding rivaroxaban to aspirin for patients with stable cardiovascular disease: results from the COMPASS trial.,"AIMS


Adding rivaroxaban to aspirin in patients with stable atherosclerotic disease reduces the recurrence of cardiovascular disease (CVD) but increases the risk of major bleeding. The aim of this study was to estimate the individual lifetime treatment benefit and harm of adding low-dose rivaroxaban to aspirin in patients with stable cardiovascular disease.
METHODS AND RESULTS


Patients with established CVD from the COMPASS trial (n = 27 390) and SMART prospective cohort study (n = 8139) were used. Using the pre-existing lifetime SMART-REACH model for recurrent CVD, and a newly developed Fine and Gray competing risk-adjusted lifetime model for major bleeding, individual treatment effects from adding low-dose rivaroxaban to aspirin in patients with stable CVD were estimated, expressed in terms of (i) life-years free of stroke or myocardial infarction (MI) gained; and (ii) life-years free from major bleeding lost. Calibration of the SMART-REACH model for prediction of recurrent CVD events in the COMPASS study was good. The major bleeding risk model as derived in the COMPASS trial showed good external calibration in the SMART cohort. Predicted individual gain in life expectancy free of stroke or MI from added low-dose rivaroxaban had a median of 16 months (range 1-48 months), while predicted individualized lifetime lost in terms of major bleeding had a median of 2 months (range 0-20 months).
CONCLUSION


There is a wide distribution in lifetime gain and harm from adding low-dose rivaroxaban to aspirin in individual patients with stable CVD. Using these lifetime models, benefits and bleeding risk can be weighed for each individual patient, which could facilitate treatment decisions in clinical practice.",2019,There is a wide distribution in lifetime gain and harm from adding low-dose rivaroxaban to aspirin in individual patients with stable CVD.,"['patients with stable CVD', 'Patients with established CVD from the COMPASS trial (n\u2009=\u200927\xa0390) and SMART prospective cohort study (n\u2009=\u20098139', 'patients with stable atherosclerotic disease', 'individual patients with stable CVD', 'patients with stable cardiovascular disease']","['rivaroxaban', 'rivaroxaban to aspirin', 'aspirin']",['recurrence of cardiovascular disease (CVD'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0235048', 'cui_str': 'Smarting pain'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}]",,0.0243844,There is a wide distribution in lifetime gain and harm from adding low-dose rivaroxaban to aspirin in individual patients with stable CVD.,"[{'ForeName': 'Tamar I', 'Initials': 'TI', 'LastName': 'de Vries', 'Affiliation': 'Department of Vascular Medicine, University Medical Center Utrecht, University Utrecht, GA Utrecht, The Netherlands.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Eikelboom', 'Affiliation': 'Population Health Research Institute, McMaster University and Hamilton Health Sciences, 237 Barton Street East, Hamilton, ON, Canada.'}, {'ForeName': 'Jackie', 'Initials': 'J', 'LastName': 'Bosch', 'Affiliation': 'Population Health Research Institute, McMaster University and Hamilton Health Sciences, 237 Barton Street East, Hamilton, ON, Canada.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Westerink', 'Affiliation': 'Department of Vascular Medicine, University Medical Center Utrecht, University Utrecht, GA Utrecht, The Netherlands.'}, {'ForeName': 'Jannick A N', 'Initials': 'JAN', 'LastName': 'Dorresteijn', 'Affiliation': 'Department of Vascular Medicine, University Medical Center Utrecht, University Utrecht, GA Utrecht, The Netherlands.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Alings', 'Affiliation': 'Department of Cardiology, Amphia Hospital, Langendijk 75, EV Breda, The Netherlands.'}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Dyal', 'Affiliation': 'Population Health Research Institute, McMaster University and Hamilton Health Sciences, 237 Barton Street East, Hamilton, ON, Canada.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Berkowitz', 'Affiliation': 'Clinical Development, Thrombosis, Bayer U.S. LLC, Whippany, NJ, USA.'}, {'ForeName': 'Yolanda', 'Initials': 'Y', 'LastName': 'van der Graaf', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, University Utrecht, Universiteitsweg 100, CG Utrecht, The Netherlands.'}, {'ForeName': 'Keith A A', 'Initials': 'KAA', 'LastName': 'Fox', 'Affiliation': 'Centre for Cardiovascular Science, University of Edinburgh, 49 Little France Crescent, Edinburgh, UK.'}, {'ForeName': 'Frank L J', 'Initials': 'FLJ', 'LastName': 'Visseren', 'Affiliation': 'Department of Vascular Medicine, University Medical Center Utrecht, University Utrecht, GA Utrecht, The Netherlands.'}]",European heart journal,['10.1093/eurheartj/ehz404']
2111,33094931,Gabapentin for cessation of smoking and non-smoking tobacco habits in Indian population.,"BACKGROUND


The effectiveness of Gabapentin in tobacco dependence has been evaluated by many researchers.The randomized control trials, testing the efficacy of gabapentin in quitting the habit in smokers and users of smokeless tobacco have not been published yet.We attempt to address this lacuna in knowledge in reducing dependence on tobacco use by Gabapentin.
METHODS


Our study involves 150 study subjects, 75 of whom were identified as chronic users of tobacco and assigned randomly to one of the three groups consisting of 25 subjects each. Gabapentin in tablet form was prescribed thrice a day for 8 weeks wherein Group 1 received a dose of 300mg, Group-2 received 600mg, and Group-3 was prescribed 900 mg. An age and sex matched control group have received calcium tablets as placebo in three times daily dose for a period of 8 weeks.
RESULTS


Among the three doses of Gabapentin, stoppage of habit was reported to be highest in the group-2 followed by group 1 and group 3 respectively. In our study, we found differences in response to quitting tobacco use between duration of habit prior to pharmacologic intervention amongst both smokers and the users of smokeless tobacco.
CONCLUSIONS


Gabapentin at dose of 600mg TDS has optimum effect. Smokers having smoking for more than ten years showed notable benefit with Gabapentin. Among smokeless tobacco users who quit tobacco dependence was better having history of habit less than 2 years.",2020,"Among the three doses of Gabapentin, stoppage of habit was reported to be highest in the group-2 followed by group 1 and group 3 respectively.","['cessation of smoking and non-smoking tobacco habits in Indian population', 'smokers and users of smokeless tobacco', '150 study subjects, 75 of whom were identified as chronic users of tobacco and assigned randomly to one of the three groups consisting of 25 subjects each']","['Gabapentin', 'gabapentin', 'calcium tablets as placebo']",[],"[{'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0439994', 'cui_str': 'Tobacco smoke'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C4075678', 'cui_str': 'User of smokeless tobacco'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}]","[{'cui': 'C0060926', 'cui_str': 'gabapentin'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],150.0,0.0264647,"Among the three doses of Gabapentin, stoppage of habit was reported to be highest in the group-2 followed by group 1 and group 3 respectively.","[{'ForeName': 'Akhilanand', 'Initials': 'A', 'LastName': 'Chaurasia', 'Affiliation': 'Department of Oral Medicine and Radiology, King George Medical University, Lucknow, India - chaurasiaakhilanand49@gmail.com.'}, {'ForeName': 'Saman', 'Initials': 'S', 'LastName': 'Ishrat', 'Affiliation': 'Department of Oral Medicine and Radiology, Rama Dental College, Kanpur, India.'}, {'ForeName': 'Rini', 'Initials': 'R', 'LastName': 'Tiwari', 'Affiliation': 'Department of Conservative Dentistry, King George Medical University, Lucknow, India.'}]",Minerva stomatologica,['10.23736/S0026-4970.20.04410-6']
2112,33094956,Feasibility of a Very Low Calorie Diet to Achieve a Sustainable 10% Weight Loss in Patients With Nonalcoholic Fatty Liver Disease.,"INTRODUCTION


Nonalcoholic fatty liver disease (NAFLD) is the most common liver condition worldwide. A weight loss goal of ≥10% is the recommended treatment for NAFLD; however, only a minority of patients achieve this level of weight reduction with standard dietary approaches. This study aimed to determine whether a very low calorie diet (VLCD) is an acceptable and feasible therapy to achieve and maintain a ≥10% weight loss in patients with clinically significant NAFLD.
METHODS


Patients with clinically significant NAFLD were recruited to a VLCD (∼800 kcal/d) intervention using meal replacement products. Anthropometrics, blood tests (liver and metabolic), liver stiffness, and cardiovascular disease risk were measured at baseline, post-VLCD, and at 9-month follow-up.
RESULTS


A total of 45 patients were approached of which 30 were enrolled 27 (90%) completed the VLCD intervention, and 20 (67%) were retained at 9-month follow-up. The VLCD was acceptable to patients and feasible to deliver. Intention-to-treat analysis found that 34% of patients achieved and sustained ≥10% weight loss, 51% achieved ≥7% weight loss, and 68% achieved ≥5% weight loss at 9-month follow-up. For those completing the VLCD, liver health (liver enzymes and liver stiffness), cardiovascular disease risk (blood pressure and QRISK2), metabolic health (fasting glucose, HbA1c, and insulin), and body composition significantly improved post-VLCD and was maintained at 9 months.
DISCUSSION


VLCD offers a feasible treatment option for some patients with NAFLD to enable a sustainable ≥10%, weight loss, which can improve liver health, cardiovascular risk, and quality of life in those completing the intervention.",2020,"For those completing the VLCD, liver health (liver enzymes and liver stiffness), cardiovascular disease risk (blood pressure and QRISK2), metabolic health (fasting glucose, HbA1c, and insulin), and body composition significantly improved post-VLCD and was maintained at 9 months.
","['Patients With Nonalcoholic Fatty Liver Disease', 'patients with clinically significant NAFLD', 'A total of 45 patients were approached of which 30 were enrolled 27 (90%) completed the VLCD intervention, and 20 (67%) were retained at 9-month follow-up', 'Patients with clinically significant NAFLD']","['VLCD', 'low calorie diet (VLCD', 'Very Low Calorie Diet', 'VLCD (∼800 kcal/d) intervention using meal replacement products']","['weight loss', 'VLCD, liver health (liver enzymes and liver stiffness), cardiovascular disease risk (blood pressure and QRISK2), metabolic health (fasting glucose, HbA1c, and insulin), and body composition', 'Anthropometrics, blood tests (liver and metabolic), liver stiffness, and cardiovascular disease risk', 'liver health, cardiovascular risk, and quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0452268', 'cui_str': 'Very low energy diet'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0452268', 'cui_str': 'Very low energy diet'}, {'cui': 'C2930544', 'cui_str': 'Calorie restricted diet'}, {'cui': 'C0456649', 'cui_str': 'kcal/day'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0452268', 'cui_str': 'Very low energy diet'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0018941', 'cui_str': 'Blood test'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",45.0,0.0206811,"For those completing the VLCD, liver health (liver enzymes and liver stiffness), cardiovascular disease risk (blood pressure and QRISK2), metabolic health (fasting glucose, HbA1c, and insulin), and body composition significantly improved post-VLCD and was maintained at 9 months.
","[{'ForeName': 'Jadine', 'Initials': 'J', 'LastName': 'Scragg', 'Affiliation': '1Population Health Sciences Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom; 2Newcastle NIHR Biomedical Research Centre, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, United Kingdom; 3School of Health & Life Sciences, Teesside University, Tees Valley, United Kingdom; 4Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom; 5Liver Unit, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Avery', 'Affiliation': ''}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Cassidy', 'Affiliation': ''}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Taylor', 'Affiliation': ''}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Haigh', 'Affiliation': ''}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Boyle', 'Affiliation': ''}, {'ForeName': 'Michael I', 'Initials': 'MI', 'LastName': 'Trenell', 'Affiliation': ''}, {'ForeName': 'Quentin M', 'Initials': 'QM', 'LastName': 'Anstee', 'Affiliation': ''}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'McPherson', 'Affiliation': ''}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Hallsworth', 'Affiliation': ''}]",Clinical and translational gastroenterology,['10.14309/ctg.0000000000000231']
2113,33091614,Acute and chronic effects of high-intensity interval and moderate-intensity continuous exercise on heart rate and its variability after recent myocardial infarction: a randomized controlled trial.,"BACKGROUND


Resting heart rate (HR) and HR variability (HRV) are known to predict mortality in patients after myocardial infarction (MI).
OBJECTIVE


We assessed acute and chronic effects of high-intensity interval training (HIIT) versus moderate-intensity continuous exercise (MICE) on HR and HRV in individuals after acute ST-segment elevation MI (STEMI).
METHODS


Participants within 7 weeks after MI were randomly assigned to HIIT or MICE groups for a 9-week intervention. HR and the power spectrum of HRV were measured pre- and post-intervention by using orthostatic challenge and during sleep to assess chronic effects. Sleep measurements were performed at night after HIIT, MICE or no training to assess acute effects. Mixed models assessed time*group interaction for differences in chronic and acute effects, adjusted for beta-blocker dose and number of training sessions.
RESULTS


Overall, 34 of 37 and 35 of 36 participants in the HIIT and MICE groups completed the study. We found a trend for an acute increase in HR of 2.5 bpm (4%, p=0.023) during sleep after HIIT. We found a trend for a chronic decrease in HR during supine and standing position as well as during sleep in the MICE group but a trend for an increase in HR during supine and standing position in the HIIT group. Low- and high-frequency power (LF, HF) of the standing segment increased from pre- to post-intervention in the MICE group but decreased in the HIIT group (group*time interaction p=0.005 and p=0.026, respectively).
CONCLUSION


HR during sleep was increased acutely during the night after HIIT but not after MICE as compared with controls. Chronic effects on resting HR, HF and LF tended to be more beneficial after MICE than HIIT in individuals with recent STEMI.",2020,"Chronic effects on resting HR, HF and LF tended to be more beneficial after MICE than HIIT in individuals with recent STEMI.","['patients after myocardial infarction (MI', 'Participants within 7 weeks after MI', 'individuals after acute ST-segment elevation MI (STEMI']","['HIIT or MICE', 'high-intensity interval training (HIIT) versus moderate-intensity continuous exercise (MICE', 'high-intensity interval and moderate-intensity continuous exercise']","['Low- and high-frequency power (LF, HF) of the standing segment', 'heart rate', 'heart rate (HR) and HR variability (HRV', 'Sleep measurements']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1303258', 'cui_str': 'Acute ST segment elevation myocardial infarction'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}]","[{'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}]",,0.112169,"Chronic effects on resting HR, HF and LF tended to be more beneficial after MICE than HIIT in individuals with recent STEMI.","[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Eser', 'Affiliation': 'Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Switzerland. Electronic address: Prisca.eser@insel.ch.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Jaeger', 'Affiliation': 'Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Switzerland; Department of Sport, Exercise and Health, Medical Faculty, University of Basel, Basel, Switzerland.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Marcin', 'Affiliation': 'Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Switzerland.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Herzig', 'Affiliation': 'Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Switzerland; Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Bern University Hospital and University of Bern, Bern, Switzerland.'}, {'ForeName': 'L D', 'Initials': 'LD', 'LastName': 'Trachsel', 'Affiliation': 'Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Switzerland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Wilhelm', 'Affiliation': 'Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Switzerland.'}]",Annals of physical and rehabilitation medicine,['10.1016/j.rehab.2020.09.008']
2114,33091807,Modality effects in verbal working memory updating: Transcranial direct current stimulation over human inferior frontal gyrus and posterior parietal cortex.,"Verbal working memory (VWM) involves visual and auditory verbal information. Neuroimaging studies have shown significant modality effects for VWM in the left posterior parietal cortex (PPC). The left inferior frontal gyrus (IFG) is more sensitive to auditory and phonological information. However, much less is known about the effects of transcranial direct current stimulation (tDCS) over the left PPC and IFG on different sensory modalities of VWM (auditory vs. visual). Therefore, the present study aimed to examine whether tDCS over the left PPC and IFG affects visual and auditory VWM updating performance using a single-blind design. Fifty-one healthy participants were randomly assigned to three tDCS groups (left PPC/left IFG/sham) and were asked to complete both the visual and auditory letter 3-back tasks. Results showed that stimulating the left PPC enhanced the response efficiency of visual, but not auditory, VWM compared with the sham condition. Anodal stimulation to the left IFG improved the response efficiency of both tasks. The present study revealed a modality effect of VWM in the left PPC, while the left IFG had a causal role in VWM updating of different sensory modalities.",2020,"Results showed that stimulating the left PPC enhanced the response efficiency of visual, but not auditory, VWM compared with the sham condition.",['Fifty-one healthy participants'],"['tDCS', 'tDCS groups (left PPC/left IFG/sham) and were asked to complete both the visual and auditory letter 3-back tasks', 'transcranial direct current stimulation (tDCS']","['response efficiency of visual', 'Verbal working memory (VWM) involves visual and auditory verbal information']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0456856', 'cui_str': 'Left posterior'}, {'cui': 'C0030560', 'cui_str': 'Parietal lobe structure'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0152298', 'cui_str': 'Structure of inferior frontal gyrus'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1172410', 'cui_str': 'ASK protein, human'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}]","[{'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}]",51.0,0.031288,"Results showed that stimulating the left PPC enhanced the response efficiency of visual, but not auditory, VWM compared with the sham condition.","[{'ForeName': 'Rongjuan', 'Initials': 'R', 'LastName': 'Zhu', 'Affiliation': ""Key Laboratory for Behavior and Cognitive Neuroscience of Shaanxi Province, School of Psychology, Shaanxi Normal University, Xi'an 710062, China.""}, {'ForeName': 'Yangmei', 'Initials': 'Y', 'LastName': 'Luo', 'Affiliation': ""Key Laboratory for Behavior and Cognitive Neuroscience of Shaanxi Province, School of Psychology, Shaanxi Normal University, Xi'an 710062, China.""}, {'ForeName': 'Ziyu', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': ""Key Laboratory for Behavior and Cognitive Neuroscience of Shaanxi Province, School of Psychology, Shaanxi Normal University, Xi'an 710062, China.""}, {'ForeName': 'Xuqun', 'Initials': 'X', 'LastName': 'You', 'Affiliation': ""Key Laboratory for Behavior and Cognitive Neuroscience of Shaanxi Province, School of Psychology, Shaanxi Normal University, Xi'an 710062, China. Electronic address: youxuqun@snnu.edu.cn.""}]",Brain and cognition,['10.1016/j.bandc.2020.105630']
2115,33091844,Operationalizing and selecting outcome measures for the HEALing Communities Study.,"BACKGROUND


The Helping to End Addiction Long-term SM  (HEALing) Communities Study (HCS) is a multisite, parallel-group, cluster randomized wait-list controlled trial evaluating the impact of the Communities That HEAL intervention to reduce opioid overdose deaths and associated adverse outcomes. This paper presents the approach used to define and align administrative data across the four research sites to measure key study outcomes.
METHODS


Priority was given to using administrative data and established data collection infrastructure to ensure reliable, timely, and sustainable measures and to harmonize study outcomes across the HCS sites.
RESULTS


The research teams established multiple data use agreements and developed technical specifications for more than 80 study measures. The primary outcome, number of opioid overdose deaths, will be measured from death certificate data. Three secondary outcome measures will support hypothesis testing for specific evidence-based practices known to decrease opioid overdose deaths: (1) number of naloxone units distributed in HCS communities; (2) number of unique HCS residents receiving Food and Drug Administration-approved buprenorphine products for treatment of opioid use disorder; and (3) number of HCS residents with new incidents of high-risk opioid prescribing.
CONCLUSIONS


The HCS has already made an impact on existing data capacity in the four states. In addition to providing data needed to measure study outcomes, the HCS will provide methodology and tools to facilitate data-driven responses to the opioid epidemic, and establish a central repository for community-level longitudinal data to help researchers and public health practitioners study and understand different aspects of the Communities That HEAL framework.",2020,Three secondary outcome measures will support hypothesis testing for specific evidence-based practices known to decrease opioid overdose deaths:,[],"['buprenorphine', 'HEAL intervention']","['support hypothesis testing for specific evidence-based practices known to decrease opioid overdose deaths', 'number of opioid overdose deaths, will be measured from death certificate data']",[],"[{'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C1510541', 'cui_str': 'Evidence-Based Practice'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0029944', 'cui_str': 'Drug overdose'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0449770', 'cui_str': 'Measured from'}, {'cui': 'C0011066', 'cui_str': 'Death certificate'}]",,0.102551,Three secondary outcome measures will support hypothesis testing for specific evidence-based practices known to decrease opioid overdose deaths:,"[{'ForeName': 'Svetla', 'Initials': 'S', 'LastName': 'Slavova', 'Affiliation': 'Department of Biostatistics, University of Kentucky, Healthy Kentucky Research Building RB2, Suite 260, 760 Press Avenue, Lexington, KY, 40536, USA. Electronic address: ssslav2@email.uky.edu.'}, {'ForeName': 'Marc R', 'Initials': 'MR', 'LastName': 'LaRochelle', 'Affiliation': 'Clinical Addiction Research and Education Unit, Section of General Internal Medicine, Department of Medicine, Boston University School of Medicine and Boston Medical Center, 801 Massachusetts Avenue, 2nd Floor, Boston, MA, 02218, USA. Electronic address: marc.larochelle@bmc.org.'}, {'ForeName': 'Elisabeth D', 'Initials': 'ED', 'LastName': 'Root', 'Affiliation': 'Department of Geography and Division of Epidemiology, The Ohio State University, and Translational Data Analytics Institute Columbus, The Ohio State University, 1036 Derby Hall, 154 N. Oval Mall, Columbus, OH, 43210, USA. Electronic address: root.145@osu.edu.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Feaster', 'Affiliation': 'Department of Public Health Sciences, University of Miami Miller School of Medicine, 1120 NW 14th Street, Room 1059, Miami, FL, 33136, USA. Electronic address: dfeaster@med.miami.edu.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Villani', 'Affiliation': 'National Institutes of Health, National Institute on Drug Abuse, 3WFN, MSC 6025, 301 North Stonestreet Avenue, Bethesda, MD, 20892, USA. Electronic address: jennifer.villani@nih.gov.'}, {'ForeName': 'Charles E', 'Initials': 'CE', 'LastName': 'Knott', 'Affiliation': 'Social, Statistical and Environment Sciences Survey Research Division, RTI International, 3040 E. Cornwallis Road, Research Triangle Park, NC, 27709, USA. Electronic address: cknott@rti.org.'}, {'ForeName': 'Jeffery', 'Initials': 'J', 'LastName': 'Talbert', 'Affiliation': 'Division of Biomedical Informatics, University of Kentucky College of Medicine, 267 Healthy Kentucky Research Building, 760 Press Avenue, Lexington, KY, 40536, USA. Electronic address: jeff.talbert@uky.edu.'}, {'ForeName': 'Aimee', 'Initials': 'A', 'LastName': 'Mack', 'Affiliation': 'Ohio Colleges of Medicine Government Resource Center, The Ohio State University Wexner Medical Center, 150 Pressey Hall, 1070 Carmack Road, Columbus, OH, 43210, USA. Electronic address: Aimee.mack@osumc.edu.'}, {'ForeName': 'Dushka', 'Initials': 'D', 'LastName': 'Crane', 'Affiliation': 'Ohio Colleges of Medicine Government Resource Center, The Ohio State University Wexner Medical Center, 150 Pressey Hall, 1070 Carmack Road, Columbus, OH, 43210, USA. Electronic address: Dushka.crane@osumc.edu.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Bernson', 'Affiliation': 'Massachusetts Department of Public Health, 250 Washington Street, Boston, MA, 02108, USA. Electronic address: Dana.Bernson@mass.gov.'}, {'ForeName': 'Austin', 'Initials': 'A', 'LastName': 'Booth', 'Affiliation': 'Biostatistics and Epidemiology Division, RTI International, 6110 Executive Blvd, Suite 900, Rockville, MD, 20852, USA. Electronic address: abooth@rti.org.'}, {'ForeName': 'Sharon L', 'Initials': 'SL', 'LastName': 'Walsh', 'Affiliation': 'Department of Behavioral Science and Center on Drug and Alcohol Research, University of Kentucky College of Medicine, 845 Angliana Avenue, Lexington, KY, 40508, USA. Electronic address: sharon.walsh@uky.edu.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108328']
2116,33091856,"Efficacy of cinnamon patch treatment for alleviating symptoms of overactive bladder: A double-blind, randomized, placebo-controlled trial.","BACKGROUND


Current treatments for overactive bladder (OAB) have limited efficacy, low persistence and a high rate of adverse events commonly leading to treatment cessation in clinical practice. Clinicians in Asia commonly use traditional Chinese medicine as an alternative for OAB treatment despite it having uncertain efficacy and safety. To evaluate the efficacy and safety of cinnamon patch (CP) treatment for alleviating symptoms of OAB, a double-blind randomized, placebo-controlled trial was conducted in the present study.
MATERIALS AND METHODS


In this 6-week randomized clinical trial conducted in an outpatient setting, 66 subjects diagnosed as having OAB were enrolled and treated with a placebo (n=33) or CP (n=33). The OAB symptom score (OABSS) was selected as the primary end point, and a patient perception of bladder condition (PPBC), an urgency severity scale (USS), and post-voiding residual urine (PVR) volume were selected as secondary end points. Statistical analyses were performed with IBM SPSS Statistics 20. Groups were compared using an independent sample t-test, Fisher exact test, and Chi-squared test.
RESULTS


In total, 66 participants (40 women and 26 men), 60.35 ± 12.77 years of age, were included in the intention-to-treat analyses. Baseline characteristics were comparable between the CP (n ==33) and placebo (n ==33) groups. Treatment with a CP showed statistically significant differences in reductions in OABSS scores (9.70 ± 2.20 to 6.33 ± 2.42), PPBC scores (3.36 ± 0.60 to 2.15 ± 0.83), and USS scores (2.67 ± 0.54 to 1.64 ± 0.60).
CONCLUSIONS


Compared to a placebo, treatment with CP might be considered an effective and safe complementary therapy for OAB. Further studies employing a positive control, different dosage forms, larger sample sizes, and longer treatment periods are warranted.",2020,"Treatment with a CP showed statistically significant differences in reductions in OABSS scores (9.70 ± 2.20 to 6.33 ± 2.42), PPBC scores (3.36 ± 0.60 to 2.15 ± 0.83), and USS scores (2.67 ± 0.54 to 1.64 ± 0.60).
","['66 subjects diagnosed as having OAB were enrolled and treated with a', 'overactive bladder (OAB', 'n=33) or CP (n=33', '66 participants (40 women and 26 men), 60.35 ± 12.77 years of age, were included in the\xa0intention-to-treat analyses']","['placebo', 'cinnamon patch (CP', 'cinnamon patch treatment', 'CP']","['OAB symptom score (OABSS', 'efficacy and safety', 'patient perception of bladder condition (PPBC), an urgency severity scale (USS), and post-voiding residual urine (PVR) volume', 'alleviating symptoms of overactive bladder', 'OABSS scores', 'USS scores', 'PPBC scores']","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0008802', 'cui_str': 'Cinnamomum verum'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0008802', 'cui_str': 'Cinnamomum verum'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0005682', 'cui_str': 'Urinary bladder structure'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0278024', 'cui_str': 'Residual urine'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C1274136', 'cui_str': 'Symptom control'}]",66.0,0.50229,"Treatment with a CP showed statistically significant differences in reductions in OABSS scores (9.70 ± 2.20 to 6.33 ± 2.42), PPBC scores (3.36 ± 0.60 to 2.15 ± 0.83), and USS scores (2.67 ± 0.54 to 1.64 ± 0.60).
","[{'ForeName': 'Lih-Lian', 'Initials': 'LL', 'LastName': 'Chen', 'Affiliation': 'PhD Program in Clinical Drug Development of Herbal Medicine, College of Pharmacy, Taipei Medical University, 250 Wuxing Street, Taipei 11031, Taiwan; Department of Traditional Chinese Medicine, En Chu Kong Hospital, 399 Fuxing Road, New Taipei City 23702, Taiwan.'}, {'ForeName': 'Yuh-Chiang', 'Initials': 'YC', 'LastName': 'Shen', 'Affiliation': 'PhD Program in Clinical Drug Development of Herbal Medicine, College of Pharmacy, Taipei Medical University, 250 Wuxing Street, Taipei 11031, Taiwan; National Taipei University of Nursing and Health Sciences, 365 Mingde Road, Taipei 11219, Taiwan; National Research Institute of Chinese Medicine, Ministry of Health and Welfare, 155-1 Linong Street, Sec. 2, Taipei 11221, Taiwan.'}, {'ForeName': 'Chih-Chun', 'Initials': 'CC', 'LastName': 'Ke', 'Affiliation': 'Department of Urology, En Chu Kong Hospital, 399 Fuxing Road, New Taipei City 23702, Taiwan.'}, {'ForeName': 'Zuha', 'Initials': 'Z', 'LastName': 'Imtiyaz', 'Affiliation': 'PhD Program in Clinical Drug Development of Herbal Medicine, College of Pharmacy, Taipei Medical University, 250 Wuxing Street, Taipei 11031, Taiwan.'}, {'ForeName': 'Hui-I', 'Initials': 'HI', 'LastName': 'Chen', 'Affiliation': 'PhD Program in Clinical Drug Development of Herbal Medicine, College of Pharmacy, Taipei Medical University, 250 Wuxing Street, Taipei 11031, Taiwan.'}, {'ForeName': 'Chin-Hsien', 'Initials': 'CH', 'LastName': 'Chang', 'Affiliation': 'Department of Traditional Chinese Medicine, En Chu Kong Hospital, 399 Fuxing Road, New Taipei City 23702, Taiwan; Department of Cosmetic Science, Chang Gung University of Science and Technology, 261 Wenhua 1st road, Taoyuan City 33303, Taiwan.'}, {'ForeName': 'Mei-Hsien', 'Initials': 'MH', 'LastName': 'Lee', 'Affiliation': 'PhD Program in Clinical Drug Development of Herbal Medicine, College of Pharmacy, Taipei Medical University, 250 Wuxing Street, Taipei 11031, Taiwan; Graduate Institute of Pharmacognosy, College of Pharmacy, Taipei Medical University, 250 Wuxing Street, Taipei 11031, Taiwan; Center for Reproductive Medicine & Sciences, Taipei Medical University Hospital, 252 Wuxing Street, Taipei 11031, Taiwan. Electronic address: lmh@tmu.edu.tw.'}]",Phytomedicine : international journal of phytotherapy and phytopharmacology,['10.1016/j.phymed.2020.153380']
2117,33091857,"A standardized polyphenol mixture extracted from poplar-type propolis for remission of symptoms of uncomplicated upper respiratory tract infection (URTI): A monocentric, randomized, double-blind, placebo-controlled clinical trial.","BACKGROUND


The most common symptoms of mild upper respiratory tract infections (URTIs) are sore throat, muffled dysphonia, and swelling and redness of the throat, which result from the inflammation process following acute bacterial or viral infection.
HYPOTHESIS/PURPOSE


As propolis is a natural resinous substance traditionally used to maintain oral cavity and upper respiratory tract health due to its antimicrobial and anti-inflammatory properties, the aim of this study is to evaluate the efficacy of an oral spray based on poplar-type propolis extract with a known and standardized polyphenol content, on the remission of the symptoms associated with mild uncomplicated URTIs.
STUDY DESIGN


A monocentric, randomized, double-blind, placebo-controlled clinical trial was performed.
METHODS


This study was conducted in 122 healthy adults who had perceived mild upper respiratory tract infections. Participants, randomly assigned to receive either propolis oral spray (N = 58) or placebo (N = 64), underwent four visits (baseline = t0, after 3 days = t1 and after 5 days = t2 and after a follow-up of 15 days = t3) in an outpatient setting. Propolis oral spray total polyphenol content was 15 mg/ml. The dosage was 2-4 sprays, corresponding to 12-24 mg of polyphenols, three times for five days. The duration of the study was 8 weeks.
RESULTS


After 3 days of treatment, 83% of subjects treated with propolis oral spray had remission of symptoms, while 72% of subjects in the placebo group had at least one remaining symptom. After five days, all subjects had recovered from all symptoms. This means that resolution from mild uncomplicated URTIs took place two days earlier, instead of taking place in five days as recorded in the control group. There was no relationship between the ingestion of propolis oral spray or placebo and adverse reactions.
CONCLUSION


Propolis oral spray can be used to improve both bacterial and viral uncomplicated URTI symptoms in a smaller number of days without the use of pharmacological treatment, leading to a prompt symptom resolution.",2020,"There was no relationship between the ingestion of propolis oral spray or placebo and adverse reactions.
","['uncomplicated upper respiratory tract infection (URTI', '122 healthy adults who had perceived mild upper respiratory tract infections']","['propolis oral spray (N\xa0=\xa058) or placebo', 'standardized polyphenol mixture extracted from poplar-type propolis', 'placebo']",['remission of symptoms'],"[{'cui': 'C0041912', 'cui_str': 'Upper respiratory infection'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}]","[{'cui': 'C1154184', 'cui_str': 'Oral spray'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0522458', 'cui_str': 'Populus'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",122.0,0.301597,"There was no relationship between the ingestion of propolis oral spray or placebo and adverse reactions.
","[{'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Esposito', 'Affiliation': 'Department of Pharmacy, University of Naples Federico II, via Domenico Montesano 49, 80131 Naples, Italy.'}, {'ForeName': 'Emanuele Ugo', 'Initials': 'EU', 'LastName': 'Garzarella', 'Affiliation': 'Department of Pharmacy, University of Naples Federico II, via Domenico Montesano 49, 80131 Naples, Italy.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Bocchino', 'Affiliation': 'Samnium Medical Soc. Cooperative, 82100 Benevento, Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': ""D'Avino"", 'Affiliation': 'Department of Internal Medicine, Hospital Cardarelli, Via Antonio Cardarelli, 80131 Naples, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Caruso', 'Affiliation': 'Department of Internal Medicine, Hospital Cardarelli, Via Antonio Cardarelli, 80131 Naples, Italy.'}, {'ForeName': 'Antonio Riccardo', 'Initials': 'AR', 'LastName': 'Buonomo', 'Affiliation': 'Department of Clinical Medicine and Surgery - Section of Infectious Diseases, University of Naples Federico II, via Sergio Pansini 5, 80131 Naples, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Sacchi', 'Affiliation': 'Applied Statistic Unit, Department of Earth and Environmental Sciences, University of Pavia, viale Taramelli 24, 27100 Pavia, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Galeotti', 'Affiliation': 'Department of Life Sciences, University of Modena and Reggio Emilia, Via Campi 213/D, 41121 Modena, Italy.'}, {'ForeName': 'Gian Carlo', 'Initials': 'GC', 'LastName': 'Tenore', 'Affiliation': 'Department of Pharmacy, University of Naples Federico II, via Domenico Montesano 49, 80131 Naples, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Zaccaria', 'Affiliation': 'B Natural R&D Unit, via Gran Sasso 33, 20011 Corbetta (MI), Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Daglia', 'Affiliation': 'Department of Pharmacy, University of Naples Federico II, via Domenico Montesano 49, 80131 Naples, Italy; International Research Center for Food Nutrition and Safety, Jiangsu University, Zhenjiang 212013, China. Electronic address: maria.daglia@unina.it.'}]",Phytomedicine : international journal of phytotherapy and phytopharmacology,['10.1016/j.phymed.2020.153368']
2118,33091917,Efficacy of bandage contact lenses versus eye patching in early postoperative period of Müller's muscle-conjunctival resection.,"PURPOSE


Patients with blepharoptosis who are treated with Müller's muscle-conjunctival resection (MMCR) may experience postoperative pain and discomfort related to the suture material on the palpebral conjunctiva. This study aims to compare the postoperative subjective complaints, such as pain and discomfort, with a visual analog scale (VAS) and objectively evaluate the cornea with a tear break-up time (TBUT) test and fluorescein staining following MMCR that was managed by either a bandage contact lens (BCL) or eye patching.
METHODS


Forty patients who had undergone a unilateral MMCR were randomized into two groups. Group 1 (n = 20) received a BCL and group 2 (n = 20) received an eye patch following the MMCR. Patients were evaluated postoperatively at 1 and 7 days in this prospective study. The postoperative pain was measured using a VAS, and the requirement for anti-inflammatory medication was analyzed. A slit-lamp examination was performed to evaluate the cornea with a TBUT test and fluorescein staining by objectively using the National Eye Institute (NEI) classification.
RESULTS


BCL treatment decreased the VAS score, the need for anti-inflammatory medications, and fluorescein staining using the NEI score, and increased the TBUT score significantly compared with the eye patch treatment (p < 0.001).
CONCLUSIONS


Our findings suggest that the use of a BCL may be beneficial in terms of reducing early postoperative pain and eye stinging, protecting the cornea, and retaining the ability to perform daily activities following a MMCR.",2020,"RESULTS


BCL treatment decreased the VAS score, the need for anti-inflammatory medications, and fluorescein staining using the NEI score, and increased the TBUT score significantly compared with the eye patch treatment (p < 0.001).
","[""early postoperative period of Müller's muscle-conjunctival resection"", 'Forty patients who had undergone a unilateral MMCR', 'Patients with blepharoptosis who are treated with']","[""Müller's muscle-conjunctival resection (MMCR"", 'bandage contact lenses', 'BCL', 'bandage contact lens (BCL) or eye patching', 'eye patch following the MMCR']","['TBUT score', 'postoperative pain', 'postoperative subjective complaints, such as pain and discomfort, with a visual analog scale (VAS) and objectively evaluate the cornea with a tear break-up time (TBUT) test and fluorescein staining', 'VAS score, the need for anti-inflammatory medications, and fluorescein staining using the NEI score']","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0229264', 'cui_str': 'Structure of tarsal muscle'}, {'cui': 'C1720279', 'cui_str': 'Resection of conjunctiva'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0005745', 'cui_str': 'Ptosis of eyelid'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0229264', 'cui_str': 'Structure of tarsal muscle'}, {'cui': 'C1720279', 'cui_str': 'Resection of conjunctiva'}, {'cui': 'C1562032', 'cui_str': 'Bandage contact lens'}, {'cui': 'C0004726', 'cui_str': 'Bandage'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0776981', 'cui_str': 'Eye patch'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0010031', 'cui_str': 'Corneal structure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0060520', 'cui_str': 'Fluorescein'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1955969', 'cui_str': 'National Eye Institute'}]",40.0,0.0238251,"RESULTS


BCL treatment decreased the VAS score, the need for anti-inflammatory medications, and fluorescein staining using the NEI score, and increased the TBUT score significantly compared with the eye patch treatment (p < 0.001).
","[{'ForeName': 'Mehmet Serhat', 'Initials': 'MS', 'LastName': 'Mangan', 'Affiliation': ''}, {'ForeName': 'Hatice', 'Initials': 'H', 'LastName': 'Tekcan', 'Affiliation': ''}, {'ForeName': 'Serap', 'Initials': 'S', 'LastName': 'Yurttaser Ocak', 'Affiliation': ''}]",Ophthalmic research,['10.1159/000512470']
2119,33092404,Minocycline as adjunctive treatment for major depressive disorder: Pooled data from two randomized controlled trials.,"BACKGROUND


Randomized controlled clinical trials that have investigated minocycline as an adjunctive treatment for major depressive disorder have proved promising. Data from two studies were pooled to evaluate more definitively whether the addition of minocycline to standard treatment for major depressive disorder leads to an improvement of depressive symptoms when compared with placebo.
METHODS


Both studies were multi-site, double-blinded, placebo-controlled trials of minocycline 200 mg/day added to treatment as usual during a 12-week period. The primary outcome measure was change in depressive symptoms (Montgomery-Asberg Depression Rating Scale in Dean et al. and Hamilton Depression Rating Scale in Husain et al.). Secondary outcomes were change in depression severity (Montgomery-Asberg Depression Rating Scale for Dean et al. and 9-item Patient Health Questionnaire in Husain et al.), anxiety severity (Hamilton Anxiety Rating Scale in Dean et al. and Generalized Anxiety Disorder 7-item scale in Husain et al.) and functional status, which were also evaluated as potential mediators on the primary outcome.
RESULTS


A total of 112 participants were included in the pooled data (Dean et al.,  n  = 71; Husain et al.,  n  = 41). A significant change from baseline to week 12 was noted in depressive symptoms - differential change (Placebo vs Minocycline): 9.0, 95% confidence interval = [4.2, 13.9], Cohen's  D  (95% confidence interval): 0.71 [0.29, 1.14],  p  < 0.001 - anxiety severity - differential change (Placebo vs Minocycline): 0.38, confidence interval = [0.00, 0.75], Cohen's  D  (95% confidence interval): 0.41 [0.00, 0.82],  p  = 0.050) and functional status - differential change (Placebo vs Minocycline): 1.0, 95% confidence interval = [0.4, 1.5], Cohen's  D  (95% confidence interval): 0.76 [0.34, 1.19],  p  = 0.001). Duration of illness, current use of benzodiazepine and pain medication were identified as moderators, whereas functional status as a mediator/predictor.
CONCLUSION


The improvement of depressive symptoms, anxiety severity and functional status is promising and suggests that minocycline has potential as an adjunctive treatment for major depressive disorder. However, further studies are warranted to confirm therapeutic effects of minocycline in major depressive disorder.
TRIAL REGISTRATIONS


NCT02263872, registered October 2014, and ACTRN12612000283875, registered March 2012.",2020,A significant change from baseline to week 12 was noted in depressive symptoms - differential change (Placebo vs Minocycline):,"['major depressive disorder', 'A total of 112 participants were included in the pooled data (Dean et al.,  n \u2009=\u200971; Husain et al.,  n \u2009=\u200941']","['placebo', 'minocycline', 'Placebo vs Minocycline', 'Minocycline']","['change in depressive symptoms (Montgomery-Asberg Depression Rating Scale in Dean et al. and Hamilton Depression Rating Scale', 'functional status - differential change', 'change in depression severity (Montgomery-Asberg Depression Rating Scale', 'anxiety severity (Hamilton Anxiety Rating Scale', 'Duration of illness, current use of benzodiazepine and pain medication', 'and 9-item Patient Health Questionnaire', 'depressive symptoms, anxiety severity and functional status', 'depressive symptoms', 'depressive symptoms - differential change']","[{'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0337051', 'cui_str': 'Pool'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0026187', 'cui_str': 'Minocycline'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0443199', 'cui_str': 'Differential'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}]",112.0,0.523281,A significant change from baseline to week 12 was noted in depressive symptoms - differential change (Placebo vs Minocycline):,"[{'ForeName': 'Robson', 'Initials': 'R', 'LastName': 'Zazula', 'Affiliation': 'Latin American Institute for the Science of Life and Nature, Federal University of Latin American Integration, Foz do Iguacu, Brazil.'}, {'ForeName': 'Muhammad Ishrat', 'Initials': 'MI', 'LastName': 'Husain', 'Affiliation': 'Department of Psychiatry, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Mohebbi', 'Affiliation': 'Deakin University, iMPACT, the Institute for Mental and Physical Health and Clinical Translation, Barwon Health, Geelong, Australia.'}, {'ForeName': 'Adam J', 'Initials': 'AJ', 'LastName': 'Walker', 'Affiliation': 'Deakin University, iMPACT, the Institute for Mental and Physical Health and Clinical Translation, Barwon Health, Geelong, Australia.'}, {'ForeName': 'Imran B', 'Initials': 'IB', 'LastName': 'Chaudhry', 'Affiliation': 'Department of Psychiatry, Ziauddin University, Karachi, Pakistan.'}, {'ForeName': 'Ameer B', 'Initials': 'AB', 'LastName': 'Khoso', 'Affiliation': 'Pakistan Institute of Living and Learning, Karachi, Pakistan.'}, {'ForeName': 'Melanie M', 'Initials': 'MM', 'LastName': 'Ashton', 'Affiliation': 'Deakin University, iMPACT, the Institute for Mental and Physical Health and Clinical Translation, Barwon Health, Geelong, Australia.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Agustini', 'Affiliation': 'Deakin University, iMPACT, the Institute for Mental and Physical Health and Clinical Translation, Barwon Health, Geelong, Australia.'}, {'ForeName': 'Nusrat', 'Initials': 'N', 'LastName': 'Husain', 'Affiliation': 'University of Manchester, Manchester, UK.'}, {'ForeName': 'Jfw', 'Initials': 'J', 'LastName': 'Deakin', 'Affiliation': 'University of Manchester, Manchester, UK.'}, {'ForeName': 'Allan H', 'Initials': 'AH', 'LastName': 'Young', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, UK.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Berk', 'Affiliation': 'Deakin University, iMPACT, the Institute for Mental and Physical Health and Clinical Translation, Barwon Health, Geelong, Australia.'}, {'ForeName': 'Buranee', 'Initials': 'B', 'LastName': 'Kanchanatawan', 'Affiliation': 'Department of Psychiatry, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Chee H', 'Initials': 'CH', 'LastName': 'Ng', 'Affiliation': 'The Melbourne Clinic, Department of Psychiatry, University of Melbourne, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Maes', 'Affiliation': 'Deakin University, iMPACT, the Institute for Mental and Physical Health and Clinical Translation, Barwon Health, Geelong, Australia.'}, {'ForeName': 'Lesley', 'Initials': 'L', 'LastName': 'Berk', 'Affiliation': 'Deakin University, iMPACT, the Institute for Mental and Physical Health and Clinical Translation, Barwon Health, Geelong, Australia.'}, {'ForeName': 'Ajeet B', 'Initials': 'AB', 'LastName': 'Singh', 'Affiliation': 'Deakin University, iMPACT, the Institute for Mental and Physical Health and Clinical Translation, Barwon Health, Geelong, Australia.'}, {'ForeName': 'Gin S', 'Initials': 'GS', 'LastName': 'Malhi', 'Affiliation': 'The University of Sydney, Faculty of Medicine and Health, Northern Clinical School, Department of Psychiatry, Sydney, New South Wales, Australia.'}, {'ForeName': 'Olivia M', 'Initials': 'OM', 'LastName': 'Dean', 'Affiliation': 'Deakin University, iMPACT, the Institute for Mental and Physical Health and Clinical Translation, Barwon Health, Geelong, Australia.'}]",The Australian and New Zealand journal of psychiatry,['10.1177/0004867420965697']
2120,33092420,Delayed cord clamping for prevention of intraventricular hemorrhage in preterm neonates: a randomized control trial.,"BACKGROUND


Intraventricular hemorrhage (IVH) is a common condition in preterm neonates and is responsible for substantial adverse neurodevelopmental outcome in preterm neonates. Prevention of IVH is an important intervention for better neurological outcome in these preterm neonates.
AIMS AND OBJECTIVE


This study aimed to determine whether delayed cord clamping (DCC) was superior to immediate cord clamping (ICC) for the prevention of IVH in preterm neonates.
PATIENTS AND METHODS


In this two centered prospective double-blind randomized controlled trial, eligible neonates with gestational age from 26 to 34 weeks were randomized to receive either ICC (cord clamped in 10-15 s) or DCC (cord clamped in 30-45 s) groups. The grading and severity of IVH were evaluated by cranial ultrasound scan done on the 3-4th and 7-10th days after birth.
RESULTS


Among the 148 enrolled neonates, 79 were in the ICC group and 69 were in the DCC group. There was no difference in maternal and neonatal baseline characteristics except the neonates in the DCC group weighed more (ICC 1528.77 ± 365.5 g vs. DCC 1658.11 ± 419.52 g;  p  = .047) at birth. There was no significant difference in the incidence of any grade of IVH in both groups (ICC 12.8% vs. DCC 14.5%;  p  = .745). There was a significantly higher incidence of grade I IVH (ICC 2.5% vs. DCC 13%;  p  = .024) in the DCC group. The incidence of grade II IVH (ICC 5.1% vs. DCC 0%;  p  = .123); grade III IVH (ICC 3.8% vs. DCC 1.4%;  p  = .623); and grade IV IVH (ICC 1.3% vs. DCC 0%;  p >.999) were comparable between the two groups. The incidence of a significant IVH (grades II, III, and IV) was significantly less in the DCC group (ICC 10.1% vs. DCC 1.4%,  p  = .036). The mean initial hemoglobin levels were significantly higher in neonates enrolled in DCC (15.41 ± 2.1 vs. 16.46 ± 2.45 g/dL;  p   =  .007). There was a significant reduction in the number of days of hospital stay (ICC 18.78 ± 15.42 vs. DCC 13.21 ± 16.16;  p  = .002). There was no difference in initial hematocrit, platelet count, maximum bilirubin level, and Apgar score ( p >.05).
CONCLUSIONS


Although there was no reduction in any grade of IVH, the incidence of significant IVH (grades II, III, and IV) was significantly decreased with the use of DCC in preterm neonates. Delayed cord clamping also resulted in a significant increase in birth weight, higher hemoglobin levels, and shorter hospital stays without any increase in the risks of hyper-bilirubinemia, low Apgar score, and neonatal mortality.
TRIAL REGISTRY


IRCT2014031116936N1, https://www.irct.ir/trial/15707.",2020,ICC 2.5% vs. DCC 13%;  p  = .024) in the DCC group.,"['preterm neonates', 'eligible neonates with gestational age from 26 to 34\xa0weeks', '148 enrolled neonates, 79 were in the ICC group and 69 were in the DCC group']","['delayed cord clamping (DCC', 'immediate cord clamping (ICC', 'Delayed cord clamping', 'ICC (cord clamped in 10-15\u2009s) or DCC', 'DCC']","['grade III IVH', 'incidence of grade II IVH', 'grade I IVH ', 'incidence of any grade of IVH', 'initial hematocrit, platelet count, maximum bilirubin level, and Apgar score', 'incidence of a significant IVH (grades II, III, and IV', 'grading and severity of IVH', 'mean initial hemoglobin levels', 'grade of IVH, the incidence of significant IVH (grades II, III, and IV', 'risks of hyper-bilirubinemia, low Apgar score, and neonatal mortality', 'number of days of hospital stay', 'grade IV IVH', 'birth weight, higher hemoglobin levels, and shorter hospital stays']","[{'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C3489532', 'cui_str': 'Cone-Rod Dystrophy 2'}, {'cui': 'C0175721', 'cui_str': 'Clamp'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C3489532', 'cui_str': 'Cone-Rod Dystrophy 2'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0175721', 'cui_str': 'Clamp'}]","[{'cui': 'C0949144', 'cui_str': 'Intraventricular haemorrhage grade III'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0949143', 'cui_str': 'Intraventricular haemorrhage grade II'}, {'cui': 'C0949142', 'cui_str': 'Intraventricular haemorrhage grade I'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0240059', 'cui_str': 'Ventricular hemorrhage'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0344395', 'cui_str': 'Bilirubin measurement'}, {'cui': 'C0003533', 'cui_str': 'Finding of Apgar score'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0020433', 'cui_str': 'Hyperbilirubinemia'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0027616', 'cui_str': 'Neonatal Mortality'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0949145', 'cui_str': 'Intraventricular haemorrhage grade IV'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0549448', 'cui_str': 'Increased hemoglobin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}]",148.0,0.0966247,ICC 2.5% vs. DCC 13%;  p  = .024) in the DCC group.,"[{'ForeName': 'Hemmati', 'Initials': 'H', 'LastName': 'Fariba', 'Affiliation': 'Department of Pediatrics, School of Medicine, Neonatology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Deepak', 'Initials': 'D', 'LastName': 'Sharma', 'Affiliation': 'Department of Neonatology, National Institute of Medical Science, Jaipur, India.'}, {'ForeName': 'Namavar Jahromi', 'Initials': 'NJ', 'LastName': 'Bahia', 'Affiliation': 'Department of OB-GYN, School of Medicine, Maternal-Fetal Medicine Research Center, Infertility Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Salarian', 'Initials': 'S', 'LastName': 'Leila', 'Affiliation': 'Department of Pediatrics, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Nazanin', 'Initials': 'N', 'LastName': 'Farahbakhsh', 'Affiliation': ""Department of Pulmonology, Pediatric Department, Mofid Children's Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.""}]","The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians",['10.1080/14767058.2020.1836148']
2121,33092424,Predictive value of thromboelastography for postoperative lower extremity deep venous thrombosis in gastric cancer complicated with portal hypertension patients.,"BACKGROUND


To explore the predictive value of thromboelastography (TEG) for the occurrence of lower extremity deep venous thrombosis (LDVT) in gastric cancer combined with portal hypertension patients after operation.
METHODS


172 gastric cancer patients combined with portal hypertension were randomly divided into laparoscopic surgery or laparotomy groups. All patients were taken venous blood on an empty stomach 1 day before operation, 1 day, 3 days, and 5 days after operation.
RESULTS


There was no significant difference in R value, K value, α angle, and MA before and after operation ( P  > .05). Compared with the same group before operation, the R value and K value were decreased at 1, 3, and 5 days after operation, while the α angle and MA were increased ( P  < .05). Compared with the non-LDVT group, the postoperative R value and K value in the LDVT group were significantly lower, while the α angle and MA were significantly higher ( P  < .05). The AUC of R value, K value, α angle, and MA levels at 3 days after surgery to identify patients with LDVT was 0.778, 0.718, 0.881, and 0.781, respectively. The estimated probability of the final model for LDVT was 0.622. Compared with the estimated probability ≥0.622 group, the LDVT rate in the estimated probability <0.622 group was significantly increased ( χ 2   = 60.128,  P  < .001).
CONCLUSIONS


The combination of R value, K value, α angle, and MA at 3 days after surgery has a moderately effective predictive effect for the occurrence of LDVT in gastric cancer patients combined with portal hypertension.",2020,"There was no significant difference in R value, K value, α angle, and MA before and after operation ( P  > .05).","['gastric cancer combined with portal hypertension patients after operation', 'gastric cancer complicated with portal hypertension patients', '172 gastric cancer patients combined with portal hypertension', 'gastric cancer patients combined with portal hypertension']","['laparoscopic surgery or laparotomy groups', 'thromboelastography', 'thromboelastography (TEG']","['AUC of R value, K value, α angle, and MA levels', 'R value, K value, α angle, and MA', 'postoperative R value and K value', 'α angle and MA', 'R value and K value', 'LDVT rate']","[{'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0020541', 'cui_str': 'Portal hypertension'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}, {'cui': 'C4517601', 'cui_str': '172'}]","[{'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C0023038', 'cui_str': 'Laparotomy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040017', 'cui_str': 'Thromboelastography'}]","[{'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}]",172.0,0.0156727,"There was no significant difference in R value, K value, α angle, and MA before and after operation ( P  > .05).","[{'ForeName': 'Chunhong', 'Initials': 'C', 'LastName': 'Gong', 'Affiliation': 'Department of Blood Transfusion, Xianning Central Hospital, The First Affiliated Hospital of Hubei University of Science and Technology , Xianning, P.R. China.'}, {'ForeName': 'Kaihu', 'Initials': 'K', 'LastName': 'Yu', 'Affiliation': 'Department of Radiology, Xianning Central Hospital, The First Affiliated Hospital of Hubei University of Science and Technology , Xianning, P.R. China.'}, {'ForeName': 'Nianrong', 'Initials': 'N', 'LastName': 'Zhang', 'Affiliation': 'Department of Radiology, Xianning Central Hospital, The First Affiliated Hospital of Hubei University of Science and Technology , Xianning, P.R. China.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Department of Pediatrics, Xianning Central Hospital, The First Affiliated Hospital of Hubei University of Science and Technology , Xianning, P.R. China.'}]","Clinical and experimental hypertension (New York, N.Y. : 1993)",['10.1080/10641963.2020.1836194']
2122,33092479,Exploring the Environmental Manifestation of Types of Music on Reinforcing Mindfulness and Concurrent Calorie Intake.,"BACKGROUND


The role of music on energy intake is conflicting, and recent research has suggested a positive association between classical music listening and mindfulness.
OBJECTIVE


The purpose of the present study was to investigate the effect of music, specifically classical music on state mindfulness and calorie intake of energy-dense foods.
METHOD


One hundred participants were randomly assigned to either a classical, popular or no music condition, and were served a variety of sweet (i.e., chocolate and cookies) and savoury (i.e., crisps) energy-dense foods. Results: The results found no significant differences in state mindfulness, overall calorie intake, or intake of sweet foods across the three conditions. However, participants in the classical music condition did consume significantly less savoury food than those in the no music condition.
CONCLUSION


Playing classical music may be beneficial in reducing intake of savoury foods, but not through the association to changes in state mindfulness. Future research should explore extended sessions of music listening on state mindfulness and other experiential evaluations of mindfulness to conclude on the direct and indirect effects of music on sweet and savoury foods.",2020,"However, participants in the classical music condition did consume significantly less savoury food than those in the no music condition.
",['One hundred participants'],"['Playing classical music', 'classical, popular or no music condition, and were served a variety of sweet (i.e., chocolate and cookies) and savoury (i.e., crisps) energy-dense foods']","['state mindfulness, overall calorie intake, or intake of sweet foods']","[{'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0681251', 'cui_str': 'Classical Music'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0085077', 'cui_str': 'Acute febrile neutrophilic dermatosis'}, {'cui': 'C0006622', 'cui_str': 'Theobroma cacao'}, {'cui': 'C3853210', 'cui_str': 'Cookie'}, {'cui': 'C0349380', 'cui_str': 'Potato chips'}, {'cui': 'C0453831', 'cui_str': 'High energy food'}]","[{'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0453865', 'cui_str': 'Sweet food'}]",100.0,0.0543984,"However, participants in the classical music condition did consume significantly less savoury food than those in the no music condition.
","[{'ForeName': 'Misba', 'Initials': 'M', 'LastName': 'Hussain', 'Affiliation': 'Department of Psychology, Birmingham City University, Birmingham, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Egan', 'Affiliation': 'Department of Psychology, Birmingham City University, Birmingham, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Keyte', 'Affiliation': 'Department of Psychology, Birmingham City University, Birmingham, UK.'}, {'ForeName': 'Michail', 'Initials': 'M', 'LastName': 'Mantzios', 'Affiliation': 'Department of Psychology, Birmingham City University, Birmingham, UK.'}]",Psychological reports,['10.1177/0033294120967276']
2123,33092478,Combined Effect of Age and Baseline Alberta Stroke Program Early Computed Tomography Score on Post-Thrombectomy Clinical Outcomes in the MR CLEAN Registry.,"BACKGROUND AND PURPOSE


Ischemic brain tissue damage in patients with acute ischemic stroke, as measured by the Alberta Stroke Program Early CT Score (ASPECTS) may be more impactful in older than in younger patients, although this has not been studied. We aimed to investigate a possible interaction effect between age and ASPECTS on functional outcome in acute ischemic stroke patients undergoing endovascular treatment, and compared reperfusion benefit across age and ASPECTS subgroups.
METHODS


Patients with ischemic stroke from the MR CLEAN Registry (Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands; March 2014-November 2017) were included. Multivariable ordinal logistic regression was performed to obtain effect size estimates (adjusted common odds ratio) on functional outcome (modified Rankin Scale score) for continuous age and granular ASPECTS, with a 2-way multiplicative interaction term (age×ASPECTS). Outcomes in four patient subgroups based on age (< versus ≥ median age [71.8 years]) and baseline ASPECTS (6-10 versus 0-5) were assessed.
RESULTS


We included 3279 patients. There was no interaction between age and ASPECTS on modified Rankin Scale ( P =0.925). The highest proportion of modified Rankin Scale 5 to 6 was observed in patients >71.8 years with baseline ASPECTS 0 to 5 (68/107, 63.6%). There was benefit of reperfusion in all age-ASPECTS subgroups. Although the adjusted common odds ratio was lower in patients >71.8 years with ASPECTS 0 to 5 (adjusted common odds ratio, 1.60 [95% CI, 0.66-3.88], n=110), there was no significant difference from the main effect ( P =0.299).
CONCLUSIONS


Although the proportion of poor outcomes following endovascular treatment was highest in older patients with low baseline ASPECTS, outcomes did not significantly differ from the main effect. These results do not support withholding endovascular treatment based n a combination of high age and low ASPECTS.",2020,There was no interaction between age and ASPECTS on modified Rankin Scale ( P =0.925).,"['3279 patients', 'acute ischemic stroke patients undergoing endovascular treatment, and compared reperfusion benefit across age and ASPECTS subgroups', 'patients with acute ischemic stroke', 'four patient subgroups based on age (< versus ≥ median age [71.8 years]) and baseline ASPECTS (6-10 versus 0-5) were assessed', 'Patients with ischemic stroke from the MR CLEAN Registry ', 'Acute Ischemic Stroke in the Netherlands; March 2014-November 2017']",['Endovascular Treatment'],"['modified Rankin Scale', 'functional outcome (modified Rankin Scale score', 'highest proportion of modified Rankin Scale']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0035124', 'cui_str': 'Reperfusion'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0001914', 'cui_str': 'Alberta'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205250', 'cui_str': 'High'}]",3279.0,0.0687244,There was no interaction between age and ASPECTS on modified Rankin Scale ( P =0.925).,"[{'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Ospel', 'Affiliation': 'Clinical Neurosciences, University of Calgary, Alberta, Canada. (J.O., M.G.).'}, {'ForeName': 'Manon', 'Initials': 'M', 'LastName': 'Kappelhof', 'Affiliation': 'Radiology & Nuclear Medicine, Amsterdam UMC, University of Amsterdam, the Netherlands. (M.K., L.F.M.B., C.B.L.M.M.).'}, {'ForeName': 'Adrien E', 'Initials': 'AE', 'LastName': 'Groot', 'Affiliation': 'Neurology, Amsterdam UMC, University of Amsterdam, the Netherlands. (A.E.G., N.E.L., J.M.C., Y.B.W.E.M.R.).'}, {'ForeName': 'Natalie E', 'Initials': 'NE', 'LastName': 'LeCouffe', 'Affiliation': 'Neurology, Amsterdam UMC, University of Amsterdam, the Netherlands. (A.E.G., N.E.L., J.M.C., Y.B.W.E.M.R.).'}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Coutinho', 'Affiliation': 'Neurology, Amsterdam UMC, University of Amsterdam, the Netherlands. (A.E.G., N.E.L., J.M.C., Y.B.W.E.M.R.).'}, {'ForeName': 'Albert J', 'Initials': 'AJ', 'LastName': 'Yoo', 'Affiliation': 'Radiology, Texas Stroke Institute, Dallas (A.J.Y.).'}, {'ForeName': 'Lonneke S F', 'Initials': 'LSF', 'LastName': 'Yo', 'Affiliation': 'Radiology, Catharina Hospital, Eindhoven, the Netherlands (L.S.F.Y.).'}, {'ForeName': 'Ludo F M', 'Initials': 'LFM', 'LastName': 'Beenen', 'Affiliation': 'Radiology & Nuclear Medicine, Amsterdam UMC, University of Amsterdam, the Netherlands. (M.K., L.F.M.B., C.B.L.M.M.).'}, {'ForeName': 'Wim H', 'Initials': 'WH', 'LastName': 'van Zwam', 'Affiliation': 'Radiology and Nuclear Medicine, Cardiovascular Research Institute Maastricht, School for Mental Health and Sciences, Maastricht University Medical Center, the Netherlands (W.H.v.Z., A.A.P.).'}, {'ForeName': 'Aad', 'Initials': 'A', 'LastName': 'van der Lugt', 'Affiliation': 'Radiology and Nuclear Medicine, Erasmus MC - University Medical Center, Rotterdam, the Netherlands (A.v.d.L.).'}, {'ForeName': 'Alida A', 'Initials': 'AA', 'LastName': 'Postma', 'Affiliation': 'Radiology and Nuclear Medicine, Cardiovascular Research Institute Maastricht, School for Mental Health and Sciences, Maastricht University Medical Center, the Netherlands (W.H.v.Z., A.A.P.).'}, {'ForeName': 'Yvo B W E M', 'Initials': 'YBWEM', 'LastName': 'Roos', 'Affiliation': 'Neurology, Amsterdam UMC, University of Amsterdam, the Netherlands. (A.E.G., N.E.L., J.M.C., Y.B.W.E.M.R.).'}, {'ForeName': 'Mayank', 'Initials': 'M', 'LastName': 'Goyal', 'Affiliation': 'Clinical Neurosciences, University of Calgary, Alberta, Canada. (J.O., M.G.).'}, {'ForeName': 'Charles B L M', 'Initials': 'CBLM', 'LastName': 'Majoie', 'Affiliation': 'Radiology & Nuclear Medicine, Amsterdam UMC, University of Amsterdam, the Netherlands. (M.K., L.F.M.B., C.B.L.M.M.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Stroke,['10.1161/STROKEAHA.120.031773']
2124,33092501,Evaluation of the Cardioprotective Effect of Granulocyte Colony Stimulating Factor in Patients with Carbon Monoxide Poisoning.,"BACKGROUND


Carbon monoxide (CO), which is well known as silent killer, has many toxic effects on organs with high rate of metabolism such as heart and brain. CO-induced cardiotoxicity resulted in a wide range of disabilities including electrocardiogram (ECG) abnormalities, elevation in level of cardiac enzymes, arrhythmias, impairment of left ventricular and myocardial infarction (MI). Cardio-protective effects of Granulocyte colony-stimulating factor (G-CSF) on infarcted heart was proved previously in various reports.
OBJECTIVE


In this study, possible effect of G-CSF on cardiac function of patients with moderate to severe acute CO poisoning was investigated.
METHODS


Cardioprotective effects of G-CSF in CO-poisoned patients was evaluated through ECG, Holter monitoring, echocardiography, and biochemical studies. Continuous intravenous infusion of G-CSF (90 µg/kg) and normal saline were administered respectively to treatment and placebo groups.
RESULTS


The results demonstrated that in moderate to severe CO poisoning, myocardial injury is common. ECG changes (e.g., ST-segment and T-wave changes, QTC), cardiac arrhythmias (e.g., heart blocks and ventricular arrhythmias), serum level of Troponin I, left ventricular ejection fraction were determined after G-CSF administration. Frequencies of ST depression, inversion or flatting of T wave and QTC in ECG were significantly reduced after G-CSF treatment. In addition, in-cidence of cardiac arrhythmias due to CO poisoning were reduced after G-CSF treatment. However, G-CSF did not exert protective effects on TPI level and function of left ventricular in CO-poisoned patients.
CONCLUSION


GCSF could probably reduce CO-induced cardiac ischemia in patients with acute CO poisoning.",2020,"Frequencies of ST depression, inversion or flatting of T wave and QTC in ECG were significantly reduced after G-CSF treatment.","['patients with acute CO poisoning', 'Patients with Carbon Monoxide Poisoning', 'patients with moderate to severe acute CO poisoning']","['GCSF', 'Carbon monoxide (CO', 'Granulocyte colony-stimulating factor (G-CSF', 'Granulocyte Colony Stimulating Factor', 'CO-induced cardiotoxicity', 'placebo', 'G-CSF', 'normal saline']","['ECG changes (e.g., ST-segment and T-wave changes, QTC), cardiac arrhythmias (e.g., heart blocks and ventricular arrhythmias), serum level of Troponin I, left ventricular ejection fraction', 'TPI level and function of left ventricular', 'electrocardiogram (ECG) abnormalities, elevation in level of cardiac enzymes, arrhythmias, impairment of left ventricular and myocardial infarction (MI', 'CO-induced cardiac ischemia', 'cardiac function', 'Frequencies of ST depression, inversion or flatting of T wave and QTC in ECG', 'CO poisoning']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0007020', 'cui_str': 'Carbon monoxide poisoning'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]","[{'cui': 'C0079459', 'cui_str': 'Colony-stimulating factor, granulocytic'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0876994', 'cui_str': 'Cardiotoxicity'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}]","[{'cui': 'C0855329', 'cui_str': 'Electrocardiogram change'}, {'cui': 'C0429029', 'cui_str': 'ST segment'}, {'cui': 'C0429103', 'cui_str': 'T wave feature'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0860814', 'cui_str': 'QTc'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0018794', 'cui_str': 'Heart block'}, {'cui': 'C0085612', 'cui_str': 'Ventricular arrhythmia'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0077401', 'cui_str': 'Troponin I'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0201934', 'cui_str': 'Cardiac enzymes/isoenzymes measurement'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0520887', 'cui_str': 'ST segment depression'}, {'cui': 'C0021943', 'cui_str': 'Chromosome inversion'}, {'cui': 'C0007020', 'cui_str': 'Carbon monoxide poisoning'}]",,0.0452015,"Frequencies of ST depression, inversion or flatting of T wave and QTC in ECG were significantly reduced after G-CSF treatment.","[{'ForeName': 'Atena', 'Initials': 'A', 'LastName': 'Pourtaji', 'Affiliation': 'Pharmaceutical Research Center, Department of Pharmacodynamics and Toxicology, School of Pharmacy, Mashhad University of Medical Sciences, Mashhad. Iran.'}, {'ForeName': 'Amirhossein', 'Initials': 'A', 'LastName': 'Sahebkar', 'Affiliation': 'Biotechnology Research Center, Pharmaceutical Technology Institute, Mashhad University of Medical Sciences, Mashhad. Iran.'}, {'ForeName': 'Hoorak', 'Initials': 'H', 'LastName': 'Poorzand', 'Affiliation': 'Atherosclerosis Prevention Research Center, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad. Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Moshiri', 'Affiliation': 'Medical Toxicology Research Center, School of Medicine, Mashhad University of Medical Sciences, Mashhad. Iran.'}, {'ForeName': 'Amir Hooshang', 'Initials': 'AH', 'LastName': 'Mohammadpour', 'Affiliation': 'Pharmaceutical Research Center, Pharmaceutical Technology Institute, Mashhad University of Medical Sciences, Mashhad. Iran.'}, {'ForeName': 'Seyed Reza', 'Initials': 'SR', 'LastName': 'Mousavi', 'Affiliation': 'Medical Toxicology Research Center, School of Medicine, Mashhad University of Medical Sciences, Mashhad. Iran.'}]",Protein and peptide letters,['10.2174/0929866527666201022112810']
2125,33092527,Intravesical dexmedetomidine instillation reduces postoperative catheter-related bladder discomfort in male patients under general anesthesia: a randomized controlled study.,"BACKGROUND


The catheter-related bladder discomfort (CRBD) of male patients is a common clinical problem, albeit lacking effective solutions. The present study aimed to investigate whether intravesical dexmedetomidine instillation alleviates the postoperative urinary discomfort in male patients with catheter under general anesthesia.
METHODS


This single-blinded, prospective, randomized study included a total of 167 male patients American Society of Anesthesiologists (ASA) physical status I-II scheduled for surgery under general anesthesia were allocated to two groups: 84 in the dexmedetomidine group and 83 in the control group. Dexmedetomidine group patients received intravesical instillation of the drug 0.5 μg/kg and normal saline 20 mL, while the control group received intravesical instillation of 20 mL normal saline. The catheter was clamped for 30 min after intravesical instillation for all patients. CRBD scores and urethra pain numerical rating scale (NRS) scores were measured at admittance to post-anesthesia care unit (PACU) (T0), intravesical instillation (T1), 30 min (T2), 60 min (T3), 2 h (T4) after intravesical instillation, discharged from PACU (T5), and 6 h (T6) and 24 h (T7) after the operation. Patient satisfaction at discharge from PACU and 24 h post-operation were compared between the two groups.
RESULTS


CRBD scores and urethra pain NRS scores after 30 min of intravesical dexmedetomidine instillation to 24 h post-operation were significantly lower than the control group (p < 0.001), and patient satisfaction was higher at discharge from PACU and 24 h post-operation (p < 0.001). No differences were detected in Steward score out of PACU (p = 0.213) and from the time of the end of operation to fully awake (p = 0.417).
CONCLUSION


Intravesical dexmedetomidine instillation reduces postoperative urinary discomfort and urethra pain and improves satisfaction in male patients under general anesthesia.
TRIAL REGISTRATION


Chinese Clinical Trial Registry (No. ChiCTR1800016429 ), date of registration 1st June 2018.",2020,"RESULTS


CRBD scores and urethra pain NRS scores after 30 min of intravesical dexmedetomidine instillation to 24 h post-operation were significantly lower than the control group (p < 0.001), and patient satisfaction was higher at discharge from PACU and 24 h post-operation (p < 0.001).","['male patients under general anesthesia', '167 male patients American Society of Anesthesiologists (ASA) physical status I-II scheduled for surgery under general anesthesia', 'male patients', 'male patients with catheter under general anesthesia']","['intravesical dexmedetomidine instillation', 'Intravesical dexmedetomidine instillation', 'intravesical instillation of the drug 0.5\u2009μg/kg and normal saline 20\u2009mL, while the control group received intravesical instillation of 20\u2009mL normal saline', 'Dexmedetomidine', 'dexmedetomidine', 'dexmedetomidine instillation']","['patient satisfaction', 'CRBD scores and urethra pain numerical rating scale (NRS) scores', 'postoperative urinary discomfort', 'postoperative catheter-related bladder discomfort', 'CRBD scores and urethra pain NRS scores', 'postoperative urinary discomfort and urethra pain and improves satisfaction']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C4517595', 'cui_str': '167'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}]","[{'cui': 'C0442124', 'cui_str': 'Intravesical approach'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0184959', 'cui_str': 'Instillation'}, {'cui': 'C0021917', 'cui_str': 'Instillation of bladder'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0549391', 'cui_str': 'Bladder discomfort'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0151830', 'cui_str': 'Pain in urethra'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",167.0,0.236948,"RESULTS


CRBD scores and urethra pain NRS scores after 30 min of intravesical dexmedetomidine instillation to 24 h post-operation were significantly lower than the control group (p < 0.001), and patient satisfaction was higher at discharge from PACU and 24 h post-operation (p < 0.001).","[{'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, The Second Affiliated Hospital of Anhui Medical University, 678# Furong Road, Hefei, Anhui Province, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, The Second Affiliated Hospital of Anhui Medical University, 678# Furong Road, Hefei, Anhui Province, China.'}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, The Second Affiliated Hospital of Anhui Medical University, 678# Furong Road, Hefei, Anhui Province, China.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, The Second Affiliated Hospital of Anhui Medical University, 678# Furong Road, Hefei, Anhui Province, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, The Second Affiliated Hospital of Anhui Medical University, 678# Furong Road, Hefei, Anhui Province, China.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, The Second Affiliated Hospital of Anhui Medical University, 678# Furong Road, Hefei, Anhui Province, China. zhangye_hassan@sina.com.'}]",BMC anesthesiology,['10.1186/s12871-020-01189-2']
2126,33092558,Evaluating the effectiveness of incentives to improve HIV prevention outcomes for young females in Eswatini: Sitakhela Likusasa impact evaluation protocol and baseline results.,"BACKGROUND


Eswatini continues to have the highest prevalence of HIV in the world, and one of the highest HIV incidences among adult populations (aged 15-49). This analysis reports on both key elements of study design/protocol and baseline results from an impact evaluation of an intervention incentivizing (i) initiation, enrolment, attendance or completion of some form of education, and (ii) lower risk sexual behaviour.
METHODS


The impact evaluation employs a two by two factorial design in which participants are enrolled in either the incentive for education arm ('education treatment arm' providing a conditional cash incentive) or the control arm ('education control arm'). In each of these arms, 50% of participants were randomized to also be eligible for selection - three times a year - to participate in a conditional raffle conditional on testing negative for curable STIs (syphilis and Trichomonas vaginalis).
RESULTS


Baseline recruitment and screening occurred in 2016 when a total of 6055 individuals were screened of which 4863 participated in the baseline survey, and 4819 individuals were randomized into one of the study arms. The baseline prevalence of HIV, Trichomonas vaginalis, and syphilis among adolescent girls and young women 8.20% (397/4840), 3.31% (150/4533) and 0.17% (8/4830) respectively.
CONCLUSIONS


An educational cash incentive and raffle incentive impact evaluation that addresses adolescent girls and young women who are in-education and out-of-education has the potential to reduce HIV risk in adolescent girls and young women in Eswatini.
TRIAL REGISTRATION


Name of the registry: Pan African Clinical Trials Registry.
TRIAL REGISTRATION NUMBER


PACTR201811609257043 . Date of registration: May 11, 2018 'Retrospectively registered'. URL of trial registry record: https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=4685.",2020,"The baseline prevalence of HIV, Trichomonas vaginalis, and syphilis among adolescent girls and young women 8.20% (397/4840), 3.31% (150/4533) and 0.17% (8/4830) respectively.
","['addresses adolescent girls and young women who are in-education and out-of-education', 'young females in Eswatini', 'adolescent girls and young women 8.20% (397/4840), 3.31% (150/4533) and 0.17% (8/4830) respectively', 'adult populations (aged 15-49', 'adolescent girls and young women in Eswatini', '2016 when a total of 6055 individuals were screened of which 4863 participated in the baseline survey, and 4819 individuals']","[""incentive for education arm ('education treatment arm' providing a conditional cash incentive) or the control arm ('education control arm"", 'educational cash incentive and raffle incentive impact evaluation']","['HIV prevention outcomes', 'baseline prevalence of HIV, Trichomonas vaginalis, and syphilis']","[{'cui': 'C0376649', 'cui_str': 'Addresses'}, {'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0038983', 'cui_str': 'Swaziland'}, {'cui': 'C4517432', 'cui_str': '0.17'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0282121', 'cui_str': 'Baseline Survey'}]","[{'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}]","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0040922', 'cui_str': 'Trichomonas vaginalis'}, {'cui': 'C0039128', 'cui_str': 'Syphilis'}]",6055.0,0.197428,"The baseline prevalence of HIV, Trichomonas vaginalis, and syphilis among adolescent girls and young women 8.20% (397/4840), 3.31% (150/4533) and 0.17% (8/4830) respectively.
","[{'ForeName': 'Marelize', 'Initials': 'M', 'LastName': 'Gorgens', 'Affiliation': 'The World Bank Group, 1776 G Street, Washington, DC, 20006, USA.'}, {'ForeName': 'Andrew F', 'Initials': 'AF', 'LastName': 'Longosz', 'Affiliation': 'The World Bank Group, 1776 G Street, Washington, DC, 20006, USA. aflongosz@gmail.com.'}, {'ForeName': 'Sosthenes', 'Initials': 'S', 'LastName': 'Ketende', 'Affiliation': 'The World Bank Group, 1776 G Street, Washington, DC, 20006, USA.'}, {'ForeName': 'Muziwethu', 'Initials': 'M', 'LastName': 'Nkambule', 'Affiliation': 'National Emergency Response for HIV/AIDS, Mbabane, Eswatini.'}, {'ForeName': 'Tengetile', 'Initials': 'T', 'LastName': 'Dlamini', 'Affiliation': 'National Emergency Response for HIV/AIDS, Mbabane, Eswatini.'}, {'ForeName': 'Mbuso', 'Initials': 'M', 'LastName': 'Mabuza', 'Affiliation': 'National Emergency Response for HIV/AIDS, Mbabane, Eswatini.'}, {'ForeName': 'Kelvin', 'Initials': 'K', 'LastName': 'Sikwibele', 'Affiliation': 'IHM Southern Africa, Mbabane, Eswatini.'}, {'ForeName': 'Vimbai', 'Initials': 'V', 'LastName': 'Tsododo', 'Affiliation': 'IHM Southern Africa, Mbabane, Eswatini.'}, {'ForeName': 'Mthokozisi', 'Initials': 'M', 'LastName': 'Dlamini', 'Affiliation': 'IHM Southern Africa, Mbabane, Eswatini.'}, {'ForeName': 'Futhie', 'Initials': 'F', 'LastName': 'Dennis-Langa', 'Affiliation': 'Independent, Mbabane, Eswatini.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Heard', 'Affiliation': 'The World Bank Group, 1776 G Street, Washington, DC, 20006, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Low', 'Affiliation': 'Independent, Mbabane, Eswatini.'}, {'ForeName': 'Pandu', 'Initials': 'P', 'LastName': 'Harimurti', 'Affiliation': 'The World Bank Group, 1776 G Street, Washington, DC, 20006, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Wilson', 'Affiliation': 'The World Bank Group, 1776 G Street, Washington, DC, 20006, USA.'}, {'ForeName': 'Khanya', 'Initials': 'K', 'LastName': 'Mabuza', 'Affiliation': 'National Emergency Response for HIV/AIDS, Mbabane, Eswatini.'}, {'ForeName': 'Damien', 'Initials': 'D', 'LastName': 'de Walque', 'Affiliation': 'The World Bank Group, 1776 G Street, Washington, DC, 20006, USA.'}]",BMC public health,['10.1186/s12889-020-09680-8']
2127,33095030,"Randomized, Placebo-controlled Trial of Inhaled Treprostinil for Patients at Risk for Acute Respiratory Distress Syndrome.","RATIONALE


Inhaled treprostinil may improve oxygenation and have additional antiinflammatory effects in early acute hypoxemic respiratory failure, potentially preventing or reducing severity of Acute Respiratory Distress Syndrome (ARDS).
OBJECTIVE


To determine whether administration of inhaled treprostinil to patients at risk for ARDS is feasible, safe, and efficacious.
METHODS


We performed a double-blind, placebo-controlled, single-center randomized pilot trial at a quaternary care academic medical center. Patients with acute hypoxemia due to pneumonia or signs of low-pressure pulmonary edema with a unilateral or bilateral infiltrate on chest imaging and a ≥ 4 liter per minute supplemental oxygen requirement but not requiring positive pressure ventilation were evaluated. Randomized patients received study drug or placebo (2:1 ratio respectively). Treatment was initiated at 6 breaths every four hours and titrated up to 12 breaths. Subjects were maintained on treatment for 7 days, and then tapered off over a period of 4 days. Study drug was stopped if positive pressure ventilation was required (invasive or non-invasive).
RESULTS


Fourteen patients were enrolled over a period of 31 months. Baseline characteristics were not significantly different between treatment groups with respect to age, gender, race, APACHE score, LIPS score or baseline mean SaO2/FiO2 ratio. Trends in daily baseline and 30- minute post-dose SaO2/FiO2 ratio for all treatment points were not significantly different between placebo and treprostinil. Four patients required positive pressure ventilation in the treprostinil group vs one in the placebo group.
CONCLUSIONS


Inhaled treprostinil administration is feasible in patients at risk for ARDS, but was not associated with improvement in the S/F ratio relative to placebo. Drug-associated adverse events were not severe nor unexpected based on the known adverse effect profile of inhaled treprostinil. The clinical benefit of this intervention is unclear at this time in the absence of larger studies. Clinical trial registered with Clinicaltrials.gov (NCT02370095).",2020,"Baseline characteristics were not significantly different between treatment groups with respect to age, gender, race, APACHE score, LIPS score or baseline mean SaO2/FiO2 ratio.","['early acute hypoxemic respiratory failure', 'quaternary care academic medical center', 'Patients with acute hypoxemia due to pneumonia or signs of low-pressure pulmonary edema with a unilateral or bilateral infiltrate on chest imaging and a ≥ 4 liter per minute supplemental oxygen requirement but not requiring positive pressure ventilation', 'patients at risk for ARDS', 'Fourteen patients were enrolled over a period of 31 months', 'Patients at Risk for Acute Respiratory Distress Syndrome']","['Inhaled Treprostinil', 'placebo', 'inhaled treprostinil', 'treprostinil', 'Placebo']","['SaO2/FiO2 ratio', 'positive pressure ventilation']","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C4039867', 'cui_str': 'Acute hypoxemic respiratory failure'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0034063', 'cui_str': 'Pulmonary edema'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C1531652', 'cui_str': 'Chest imaging'}, {'cui': 'C0439393', 'cui_str': 'L/min'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0021778', 'cui_str': 'Intermittent positive pressure ventilation'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C1145760', 'cui_str': 'Treprostinil'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0021778', 'cui_str': 'Intermittent positive pressure ventilation'}]",14.0,0.73009,"Baseline characteristics were not significantly different between treatment groups with respect to age, gender, race, APACHE score, LIPS score or baseline mean SaO2/FiO2 ratio.","[{'ForeName': 'H James', 'Initials': 'HJ', 'LastName': 'Ford', 'Affiliation': 'University of North Carolina at Chapel Hill, Medicine--Pulmonary and Critical Care, Chapel Hill, North Carolina, United States; hjford@med.unc.edu.'}, {'ForeName': 'Wayne H', 'Initials': 'WH', 'LastName': 'Anderson', 'Affiliation': 'University of North Carolina at Chapel Hill, Medicine, Chapel Hill, North Carolina, United States.'}, {'ForeName': 'Blair', 'Initials': 'B', 'LastName': 'Wendlandt', 'Affiliation': 'University of North Carolina at Chapel Hill School of Medicine, 6797, Chapel Hill, North Carolina, United States.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bice', 'Affiliation': 'University of North Carolina at Chapel Hill School of Medicine, 6797, Pulmonary and Critical Care Medicine, Chapel Hill, North Carolina, United States.'}, {'ForeName': 'Agathe', 'Initials': 'A', 'LastName': 'Ceppe', 'Affiliation': 'University of North Carolina at Chapel Hill, 2331, Chapel Hill, North Carolina, United States.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Lanier', 'Affiliation': 'University of North Carolina at Chapel Hill, 2331, Medicine, Chapel Hill, North Carolina, United States.'}, {'ForeName': 'Shannon S', 'Initials': 'SS', 'LastName': 'Carson', 'Affiliation': 'University of North Carolina Chapel Hill, Chapel Hill, North Carolina, United States.'}]",Annals of the American Thoracic Society,['10.1513/AnnalsATS.202004-374OC']
2128,33095032,Cardiac and Kidney Benefits of Empagliflozin in Heart Failure Across the Spectrum of Kidney Function: Insights from the EMPEROR-Reduced Trial.,"Background:  In EMPEROR-Reduced, empagliflozin reduced cardiovascular death or HF hospitalization, total HF hospitalizations, and slowed the progressive decline in kidney function in patients with HF and a reduced ejection fraction (HFrEF), with and without diabetes. We aim to study the effect of empagliflozin on cardiovascular and kidney outcomes across the spectrum of kidney function.  Methods:  In this pre-specified analysis, patients were categorized by the presence or absence of CKD at baseline (eGFR<60ml/min/1.73m 2  or UACR>300mg/g). The primary and key secondary outcomes were (1) a composite of cardiovascular death or HF hospitalization (primary outcome); (2) total HF hospitalizations, and (3) eGFR slope. The direct impact on kidney events was investigated by a prespecified composite kidney outcome (defined as a sustained profound decline in eGFR, chronic dialysis or transplant). The median follow-up was 16 months.  Results:  3730 patients were randomized to empagliflozin or placebo, of whom 1978 (53%) had CKD. Empagliflozin reduced the primary outcome and total HF hospitalizations in patients with and without CKD: primary outcome HR=0.78 (95%CI=0.65-0.93) and HR=0.72 (95%CI=0.58-0.90), respectively; interaction P=0.63. Empagliflozin slowed the slope of eGFR decline by 1.11 (0.23-1.98) ml/min/1.73m 2 /year in patients with CKD and by 2.41 (1.49-3.32) ml/min/1.73m2/year in patients without CKD. The risk of the composite kidney outcome was reduced similarly in patients with and without CKD: HR=0.53 (95%CI=0.31-0.91) and HR=0.46 (95%CI=0.22-0.99), respectively. The effect of empagliflozin on the primary composite outcome and the key secondary outcomes was consistent across a broad range of baseline kidney function, measured by clinically relevant eGFR subgroups or by albuminuria, including patients with eGFR as low as 20 ml/min/1.73m 2 . Empagliflozin was well tolerated in CKD patients.  Conclusions:  In EMPEROR-reduced, empagliflozin had a beneficial effect on the key efficacy outcomes and slowed the rate of kidney function decline in patients with and without CKD and regardless of the severity of kidney impairment at baseline.  Clinical Trial Registration:  URL: https://clinicaltrials.gov Unique Identifier: NCT03057977.",2020,"In EMPEROR-Reduced, empagliflozin reduced cardiovascular death or HF hospitalization, total HF hospitalizations, and slowed the progressive decline in kidney function in patients with HF and a reduced ejection fraction (HFrEF), with and without diabetes.","['patients with and without CKD: primary outcome', 'CKD patients', '3730 patients']","['empagliflozin or placebo', 'Empagliflozin', 'empagliflozin', 'CKD']","['slope of eGFR decline', 'cardiovascular death or HF hospitalization, total HF hospitalizations', 'risk of the composite kidney outcome', 'kidney events', 'total HF hospitalizations', 'rate of kidney function decline', 'composite of cardiovascular death or HF hospitalization (primary outcome); (2) total HF hospitalizations, and (3) eGFR slope', 'broad range of baseline kidney function', 'cardiovascular and kidney outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}]","[{'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}]","[{'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0232804', 'cui_str': 'Renal function'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",3730.0,0.23048,"In EMPEROR-Reduced, empagliflozin reduced cardiovascular death or HF hospitalization, total HF hospitalizations, and slowed the progressive decline in kidney function in patients with HF and a reduced ejection fraction (HFrEF), with and without diabetes.","[{'ForeName': 'Faiez', 'Initials': 'F', 'LastName': 'Zannad', 'Affiliation': ""Université de Lorraine, INSERM, Centre d'Investigations Cliniques Plurithématique 1433, INSERM 1116, CHRU de Nancy, FCRIN INI-CRCT, Nancy, France.""}, {'ForeName': 'João Pedro', 'Initials': 'JP', 'LastName': 'Ferreira', 'Affiliation': ""Université de Lorraine, INSERM, Centre d'Investigations Cliniques Plurithématique 1433, INSERM 1116, CHRU de Nancy, FCRIN INI-CRCT, Nancy, France.""}, {'ForeName': 'Stuart J', 'Initials': 'SJ', 'LastName': 'Pocock', 'Affiliation': 'Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Cordula', 'Initials': 'C', 'LastName': 'Zeller', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany.'}, {'ForeName': 'Stefan D', 'Initials': 'SD', 'LastName': 'Anker', 'Affiliation': 'Department of Cardiology (CVK), and Berlin Institute of Health Center for Regenerative Therapies, German Centre for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin, Germany.'}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Butler', 'Affiliation': 'Department of Medicine, University of Mississippi School of Medicine, Jackson, MS.'}, {'ForeName': 'Gerasimos', 'Initials': 'G', 'LastName': 'Filippatos', 'Affiliation': 'National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens, Greece.'}, {'ForeName': 'Sibylle Jenny', 'Initials': 'SJ', 'LastName': 'Hauske', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany; Vth Department of Medicine, University Medical Center Mannheim, University of Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Brueckmann', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany; Faculty of Medicine Mannheim, University of Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Egon', 'Initials': 'E', 'LastName': 'Pfarr', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Schnee', 'Affiliation': 'Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Wanner', 'Affiliation': 'Division of Nephrology, University Hospital, Würzburg, Germany.'}, {'ForeName': 'Milton', 'Initials': 'M', 'LastName': 'Packer', 'Affiliation': 'Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas TX; Imperial College, London, UK.'}]",Circulation,['10.1161/CIRCULATIONAHA.120.051685']
2129,33095038,Ivacaftor in People With Cystic Fibrosis and a 3849+10kb C →T or D1152H Residual Function Mutation.,"Rationale : Ivacaftor's clinical effects in the residual function mutations 3849+10kb C →T and D1152H warrant further characterization.  Objectives : Evaluate ivacaftor's effect in people with cystic fibrosis aged ≥6 years with 3849+10kb C→T or D1152H residual function mutations; explore the correlation between ivacaftor-induced organoid-based cystic fibrosis transmembrane conductance regulator function measurements and clinical response to ivacaftor.  Methods : Participants were randomized (1:1) in this placebo-controlled crossover study; each treatment sequence included two 8-week treatments with an 8-week washout period. The primary endpoint was absolute change in lung clearance index2.5 from baseline through Week 8. Additional endpoints included lung function, patient-reported outcomes, and in vitro intestinal organoid-based measurements of ivacaftor-induced cystic fibrosis transmembrane conductance regulator function.  Results : Of 38 participants, 37 completed the study. The primary endpoint was met; the Bayesian posterior probability of improvement in lung clearance index2.5 with ivacaftor vs placebo was >99%. Additional endpoints improved with ivacaftor. Safety findings were consistent with ivacaftor's known safety profile. Dose-dependent swelling was observed in 23/25 viable organoid cultures with ivacaftor treatment. Correlations between ivacaftor-induced organoid swelling and clinical endpoints were negligible to low.  Conclusions : In people with cystic fibrosis aged ≥6 years with a 3849+10kb C →T or D1152H mutation, ivacaftor treatment improved clinical endpoints vs placebo; however, there was no correlation between organoid swelling and change in clinical endpoints. The organoid assay may assist in identification of ivacaftor-responsive mutations but in this study did not predict magnitude of clinical benefit for individual people with cystic fibrosis with these two mutations. Clinical trial registered with ClinicalTrials.gov (NCT03068312).",2020,The primary endpoint was met; the Bayesian posterior probability of improvement in lung clearance index2.5 with ivacaftor vs placebo was >99%.,"['people with cystic fibrosis aged ≥6 years with a 3849+10kb C →T or D1152H mutation', 'People With Cystic Fibrosis and a 3849+10kb C →T or D1152H Residual Function Mutation', 'people with cystic fibrosis aged ≥6 years with 3849+10kb C→T or D1152H residual function mutations', '38 participants, 37 completed the study']","['ivacaftor', 'placebo', 'ivacaftor vs placebo', 'Ivacaftor']","['absolute change in lung clearance index2.5', 'lung function, patient-reported outcomes, and in vitro intestinal organoid-based measurements of ivacaftor-induced cystic fibrosis transmembrane conductance regulator function', 'Bayesian posterior probability of improvement in lung clearance index2.5']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0855766', 'cui_str': 'Residual function'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C3264621', 'cui_str': 'ivacaftor'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0021135', 'cui_str': 'In Vitro'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0029250', 'cui_str': 'Organoids'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C3264621', 'cui_str': 'ivacaftor'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0056889', 'cui_str': 'CFTR Protein'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0033204', 'cui_str': 'Probability'}]",,0.107007,The primary endpoint was met; the Bayesian posterior probability of improvement in lung clearance index2.5 with ivacaftor vs placebo was >99%.,"[{'ForeName': 'Eitan', 'Initials': 'E', 'LastName': 'Kerem', 'Affiliation': 'Hadassah-Hebrew University Medical Center, Dept of Pediatrics and Cystic Fibrosis Center, Jerusalem, Israel; kerem@hadassah.org.il.'}, {'ForeName': 'Malena', 'Initials': 'M', 'LastName': 'Cohen-Cymberknoh', 'Affiliation': 'Hadassah-Hebrew University Medical Center, Dept of Pediatrics and Cystic Fibrosis Center, Jerusalem, Jerusalem, Israel.'}, {'ForeName': 'Reuven', 'Initials': 'R', 'LastName': 'Tsabari', 'Affiliation': 'Hadassah-Hebrew University Medical Center, Dept of Pediatrics and Cystic Fibrosis Center, Jerusalem, Israel.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Wilschanski', 'Affiliation': 'Hadassah-Hebrew University Medical Center, Dept of Pediatrics and Cystic Fibrosis Center, Jerusalem, Israel.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Reiter', 'Affiliation': 'Hadassah-Hebrew University Medical Center, Dept of Pediatrics and Cystic Fibrosis Center, Jerusalem, Israel.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Shoseyov', 'Affiliation': 'Hadassah-Hebrew University Medical Center, Dept of Pediatrics and Cystic Fibrosis Center, Jerusalem, Israel.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Gileles-Hillel', 'Affiliation': 'Hadassah-Hebrew University Medical Center, Dept of Pediatrics and Cystic Fibrosis Center, Jerusalem, Israel.'}, {'ForeName': 'Thea', 'Initials': 'T', 'LastName': 'Pugatsch', 'Affiliation': 'Hadassah-Hebrew University Medical Center, Dept of Pediatrics and Cystic Fibrosis Center, Jerusalem, Israel.'}, {'ForeName': 'Jane C', 'Initials': 'JC', 'LastName': 'Davies', 'Affiliation': 'European CF Society Lung Clearance Index Core Over Reading Centre, London, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Short', 'Affiliation': 'European CF Society Lung Clearance Index Core Over Reading Centre, London, London, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Saunders', 'Affiliation': 'European CF Society Lung Clearance Index Core Over Reading Centre, London, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'DeSouza', 'Affiliation': 'Vertex Pharmaceuticals Incorporated, Boston, Massachusetts, United States.'}, {'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'Sullivan', 'Affiliation': 'Formerly of Vertex Pharmaceuticals Incorporated, Boston, Massachusetts, United States.'}, {'ForeName': 'Jamie R', 'Initials': 'JR', 'LastName': 'Doyle', 'Affiliation': 'Vertex Pharmaceuticals Incorporated, Boston, Massachusetts, United States.'}, {'ForeName': 'Keval', 'Initials': 'K', 'LastName': 'Chandarana', 'Affiliation': 'Vertex Pharmaceuticals Incorporated, Boston, Massachusetts, United States.'}, {'ForeName': 'Nils', 'Initials': 'N', 'LastName': 'Kinnman', 'Affiliation': 'Vertex Pharmaceuticals (Europe) Limited, London, United Kingdom of Great Britain and Northern Ireland.'}]",Annals of the American Thoracic Society,['10.1513/AnnalsATS.202006-659OC']
2130,33095107,"Antibiotic Prophylaxis with Piperacillin-Tazobactam Reduces Post-Operative Infectious Complication after Pancreatic Surgery: An Interventional, Non-Randomized Study.","Background:  This study aimed to evaluate the effectiveness of piperacillin-tazobactam as antibiotic prophylaxis in patients affected by a peri-ampullary tumor submitted to pancreatic surgery.  Methods:  A prospective, non-randomized, non-blinded, interventional study was conducted from January 2015 to March 2018. Patients were screened pre-operatively for Enterobacteriaceae producing extended-spectrum beta-lactamases (ESBL-PE). During the baseline period (January 2015-October 2016), surgical prophylaxis was performed with ampicillin-sulbactam. In the intervention phase (November 2016-March 2018), patients received piperacillin-tazobactam. Statistical analysis was performed by univariable and multivariable analysis with logistic regression models.  Results:  Overall, 383 patients were included in the baseline period and 296 in the intervention period. The surveillance strategy identified 47 ESBL-PE carriers (14%) in the baseline phase and 29 (10%) in the intervention phase. In the baseline period, the patients had a higher rate of hospital-acquired infection (43% versus 33%; p = 0.004), superficial surgical site infection (SSI) (11% versus 2%; p < 0.001), and pneumonia (16% versus 9%; p = 0.006). After the logistic regression, the baseline group had an odds ratio to develop superficial SSI and pneumonia of 7.7 (95% confidence interval [CI] 3-20) and 1.8 (95% CI 1-3.3), respectively. The ESBL colonization increased the mortality rate significantly (8% versus 3%; p = 0.017).  Conclusions:  Adopting antibiotic prophylaxis based on piperacillin-tazobactam is associated with a reduction in post-operative SSI, particularly superficial-SSIs. Further randomized studies would be warranted to evaluate this antibiotic combination more extensively in preventive strategies.",2020,The ESBL colonization increased the mortality rate significantly (8% versus 3%; p = 0.017).  ,"['383 patients were included in the baseline period and 296 in the intervention period', 'Pancreatic Surgery', 'January 2015 to March 2018', 'patients affected by a peri-ampullary tumor submitted to pancreatic surgery']","['ampicillin-sulbactam', 'Piperacillin-Tazobactam', 'piperacillin-tazobactam']","['pneumonia', 'mortality rate', 'rate of hospital-acquired infection', 'superficial surgical site infection (SSI', 'odds ratio to develop superficial SSI and pneumonia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0030274', 'cui_str': 'Pancreatic structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0522476', 'cui_str': 'Patient affected'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0345916', 'cui_str': 'Neoplasm of ampulla of Vater'}]","[{'cui': 'C2930041', 'cui_str': 'sultamicillin'}, {'cui': 'C0250480', 'cui_str': 'Piperacillin and tazobactam'}]","[{'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205721', 'cui_str': 'Nosocomial infection'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}]",383.0,0.214882,The ESBL colonization increased the mortality rate significantly (8% versus 3%; p = 0.017).  ,"[{'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'De Pastena', 'Affiliation': 'General and Pancreatic Surgery Department, Pancreas Institute, University and Hospital Trust of Verona, Verona, Italy.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Paiella', 'Affiliation': 'General and Pancreatic Surgery Department, Pancreas Institute, University and Hospital Trust of Verona, Verona, Italy.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Azzini', 'Affiliation': 'Infectious Diseases Unit, Department of Diagnostic and Public Health, Department of Pathology and Diagnostic, University of Verona, Verona, Italy.'}, {'ForeName': 'Amina', 'Initials': 'A', 'LastName': 'Zaffagnini', 'Affiliation': 'Infectious Diseases Unit, Department of Diagnostic and Public Health, Department of Pathology and Diagnostic, University of Verona, Verona, Italy.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Scarlini', 'Affiliation': 'Infectious Diseases Unit, Department of Diagnostic and Public Health, Department of Pathology and Diagnostic, University of Verona, Verona, Italy.'}, {'ForeName': 'Greta', 'Initials': 'G', 'LastName': 'Montagnini', 'Affiliation': 'General and Pancreatic Surgery Department, Pancreas Institute, University and Hospital Trust of Verona, Verona, Italy.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Maruccio', 'Affiliation': 'General and Pancreatic Surgery Department, Pancreas Institute, University and Hospital Trust of Verona, Verona, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Filippini', 'Affiliation': 'General and Pancreatic Surgery Department, Pancreas Institute, University and Hospital Trust of Verona, Verona, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Romeo', 'Affiliation': 'General and Pancreatic Surgery Department, Pancreas Institute, University and Hospital Trust of Verona, Verona, Italy.'}, {'ForeName': 'Annarita', 'Initials': 'A', 'LastName': 'Mazzariol', 'Affiliation': 'Department of Diagnostic and Public Health, Microbiology Division, Department of Pathology and Diagnostic, University of Verona, Verona, Italy.'}, {'ForeName': 'Giuliana', 'Initials': 'G', 'LastName': 'Lo Cascio', 'Affiliation': 'Department of Diagnostic and Public Health, Microbiology Division, Department of Pathology and Diagnostic, University of Verona, Verona, Italy.'}, {'ForeName': 'Alda', 'Initials': 'A', 'LastName': 'Bazaj', 'Affiliation': 'Department of Diagnostic and Public Health, Microbiology Division, Department of Pathology and Diagnostic, University of Verona, Verona, Italy.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Secchettin', 'Affiliation': 'General and Pancreatic Surgery Department, Pancreas Institute, University and Hospital Trust of Verona, Verona, Italy.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Bassi', 'Affiliation': 'General and Pancreatic Surgery Department, Pancreas Institute, University and Hospital Trust of Verona, Verona, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Salvia', 'Affiliation': 'General and Pancreatic Surgery Department, Pancreas Institute, University and Hospital Trust of Verona, Verona, Italy.'}]",Surgical infections,['10.1089/sur.2020.260']
2131,33095411,New Anti-Chemokine Oral Drug XC8 in the Treatment of Asthma Patients with Poor Response to Corticosteroids: Results of a Phase 2A Randomized Controlled Clinical Trial.,"INTRODUCTION


A significant number of patients with moderate asthma remain symptomatic despite treatment with inhaled corticosteroids (ICS). These patients do not yet meet the criteria for oral corticosteroids (OCS) and monoclonal antibodies. The new anti-chemokine oral drug XC8 could represent an alternative treatment option for these patients. The objective of this trial was to evaluate the effect of different doses of the XC8 in patients with partly controlled asthma in a phase 2a clinical trial.
METHODS


A double-blind, parallel-group, randomized, multicenter, phase 2a trial was conducted at 12 sites in Russia. Patients with asthma were randomized into four groups (n = 30 each) to receive XC8 at 2 mg, 10 mg, 100 mg or placebo once-daily for 12 weeks in addition to low-dose ICS with or without LABA. Efficacy and safety parameters were evaluated at weeks 0, 2, 6, and 12.
RESULTS


No statistically significant difference between the treatment arms in the number of patients with adverse events was observed. The primary endpoint, improvement of forced expiratory volume in 1 s (FEV 1 ) % predicted over 12 weeks compared to placebo, was not statistically significant. The treatment of patients with XC8 (100 mg) resulted in statistically and clinically significant improvements in FEV 1  compared to baseline (7.40% predicted, p < 0.001). Patients with elevated peripheral blood eosinophil count (PBEC, > 300 cells/μl) or serum interferon-γ (IFN-γ) level (> 100 pg/mL) treated with XC8 (100 mg) achieved a statistically significant improvement in FEV 1  (11.33% predicted or 8.69% predicted, respectively, p < 0.05) as compared to the baseline versus the placebo. The strongest effect was observed in patients with both high PBEC and IFN-γ level. Pharmacodynamic engagement was demonstrated through the reduction of serum levels of C-C motif ligand 2 (CCL2) and C-X-C motif chemokine 10 (CXCL10). Treatment with XC8 (100 mg) alleviated resistance to maintenance ICS therapy in patients with elevated IFN-γ level.
CONCLUSIONS


Given the high safety, oral route of administration, and efficacy, XC8 may provide a promising treatment option for patients with mild-to-moderate asthma.
TRIAL REGISTRATION


795-30/12/2015 (Ministry of Health Russian Federation), NCT03450434 (ClinicalTrials.gov).",2020,Pharmacodynamic engagement was demonstrated through the reduction of serum levels of C-C motif ligand 2 (CCL2) and C-X-C motif chemokine 10 (CXCL10).,"['patients with partly controlled asthma in a phase 2a clinical trial', 'patients with elevated IFN-γ level', 'patients with mild-to-moderate asthma', 'Patients with asthma', 'Asthma Patients with Poor Response to Corticosteroids', 'patients with moderate asthma remain symptomatic despite treatment with inhaled corticosteroids (ICS']","['XC8', 'New Anti-Chemokine Oral Drug XC8', 'placebo', 'XC8 at 2\xa0mg, 10\xa0mg, 100\xa0mg or placebo once-daily for 12\xa0weeks in addition to low-dose ICS with or without LABA']","['serum levels of C-C motif ligand 2 (CCL2) and C-X-C motif chemokine 10 (CXCL10', 'Efficacy and safety parameters', 'elevated peripheral blood eosinophil count (PBEC,\u2009>\u2009300 cells/μl) or serum interferon-γ (IFN-γ) level ', 'forced expiratory volume in 1\xa0s (FEV 1 ', 'FEV', 'FEV 1', 'number of patients with adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0581125', 'cui_str': 'Moderate asthma'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0282554', 'cui_str': 'Cytokines, Chemotactic'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0023688', 'cui_str': 'Ligands'}, {'cui': 'C1308752', 'cui_str': 'CXCL10 protein, human'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0200638', 'cui_str': 'Eosinophil count'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.382345,Pharmacodynamic engagement was demonstrated through the reduction of serum levels of C-C motif ligand 2 (CCL2) and C-X-C motif chemokine 10 (CXCL10).,"[{'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Romanova', 'Affiliation': 'EURRUS Biotech GmbH, Tulln, Austria. jr.romanova@gmail.com.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Chikina', 'Affiliation': 'PHARMENTERPRISES LLC, Moscow, Russia.'}, {'ForeName': 'Anastasia', 'Initials': 'A', 'LastName': 'Rydlovskaya', 'Affiliation': 'PHARMENTERPRISES LLC, Moscow, Russia.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Pohl', 'Affiliation': 'Karl Landsteiner Institute for Clinical and Experimental Pneumology, Hietzing Hospital, Vienna, Austria.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Renner', 'Affiliation': 'Karl Landsteiner Institute for Clinical and Experimental Pneumology, Hietzing Hospital, Vienna, Austria.'}, {'ForeName': 'Alexey', 'Initials': 'A', 'LastName': 'Zeifman', 'Affiliation': 'Chemimmune Therapeutics LLC, Moscow, Russia.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Chuchalin', 'Affiliation': 'Institute of Pulmonology, Federal Medical and Biological Agency, Moscow, Russia.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Nebolsin', 'Affiliation': 'PHARMENTERPRISES LLC, Moscow, Russia.'}]",Pulmonary therapy,['10.1007/s41030-020-00134-5']
2132,31937088,Does duration of stenting increase the risk of clinical infection?,"OBJECTIVE


We investigated when an indwelling ureteral catheter should be withdrawn for infection and evaluated the importance of urinary cultures in identifying colonized microorganisms and define the bacterial flora encountered in the study. Moreover, this study tried to determine the clinical role of stent culture in clinical practice.
MATERIALS AND METHODS


The study was conducted between June 2018 and February 2019. Patients with ureteral stent implantation after endoscopic ureteral stone treatment were divided into two groups and each group consisted of 45 patients. Ureteral catheter was removed 15 and 30 days after ureteral stone treatment in group 1 and 2, respectively, and transferred for microbiological examination. The urine culture was obtained before and after ureteral stent implantation. The groups were compared in terms of demographics, urine and catheter cultures results. Urine analysis and catheter culture results were also compared.
RESULTS


Demographic data of patients were similar in both groups. 3 patients in group 1 and 12 patients in group 2 had positive urine culture before catheter retraction; 2 of 45 and 6 of 45 patients had positive catheter culture in group 1 and 2, respectively. Although 2 patients in group 1 and 4 patients in group 2 had urine culture sterile, they had growth in catheter culture. In Group 1, 1 of the microorganisms was E. fecalis and 1 was E. coli. In Group 2, 2 cases were E. fecalis, 3 were E. coli and 1 was MRSE. There was no significant difference between the urine analysis results of the patients before catheter retraction and catheter culture positivity.
CONCLUSIONS


Pre-operative urine culture does not exclude catheter colonization, and the prolonged duration of the catheter associated with greater colonization and may be associated urinary tract infection. Ureteral catheter should be removed as early as possible.",2020,"There was no significant difference between the urine analysis results of the patients before catheter retraction and catheter culture positivity.
","['Patients with ureteral stent implantation after endoscopic ureteral stone treatment', 'June 2018 and February 2019']",[],"['positive catheter culture', 'urine culture sterile', 'urine culture', 'growth in catheter culture', 'positive urine culture']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0183518', 'cui_str': 'Ureteric stent'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0041952', 'cui_str': 'Ureteric stone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",[],"[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C2609170', 'cui_str': 'Catheter culture'}, {'cui': 'C0430404', 'cui_str': 'Urine culture'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0018270', 'cui_str': 'Growth'}]",,0.0409596,"There was no significant difference between the urine analysis results of the patients before catheter retraction and catheter culture positivity.
","[{'ForeName': 'Tuncay', 'Initials': 'T', 'LastName': 'Toprak', 'Affiliation': 'Department of Urology, Fatih Sultan Mehmet Training and Research Hospital, Istanbul. drtuncay55@hotmail.com.'}, {'ForeName': 'Aytaç', 'Initials': 'A', 'LastName': 'Şahin', 'Affiliation': ''}, {'ForeName': 'Musab Ali', 'Initials': 'MA', 'LastName': 'Kutluhan', 'Affiliation': ''}, {'ForeName': 'Korhan', 'Initials': 'K', 'LastName': 'Akgul', 'Affiliation': ''}, {'ForeName': 'Yavuz Onur', 'Initials': 'YO', 'LastName': 'Danacıoğlu', 'Affiliation': ''}, {'ForeName': 'Mehmet Akif', 'Initials': 'MA', 'LastName': 'Ramazanoğlu', 'Affiliation': ''}, {'ForeName': 'Ayhan', 'Initials': 'A', 'LastName': 'Verit', 'Affiliation': ''}]","Archivio italiano di urologia, andrologia : organo ufficiale [di] Societa italiana di ecografia urologica e nefrologica",['10.4081/aiua.2019.4.237']
2133,32126972,Physical function in patients newly diagnosed with multiple myeloma; a Danish cohort study.,"BACKGROUND


Multiple myeloma is a cancer in the bone marrow causing bone destruction. Patients experience various symptoms related to the disease and/or treatment, such as pain and fatigue, leading to poorer quality of life. The symptom burden might affect physical function and physical activity levels, posing a risk of physical deterioration. The aim was to investigate whether physical function in newly diagnosed patients with multiple myeloma differs from the reference values of the normal population and other cancer patients.
METHODS


The study is a cross sectional descriptive analysis of a prospective cohort of 100 patients newly diagnosed with multiple myeloma. Four physical function tests were carried out; Six-Minute-Walk-Test, Sit-to-Stand-Test, grip strength and knee extension strength. Age and gender specific results of physical function from the multiple myeloma population were compared to normative data and to data from other cancer populations.
RESULTS


Of the 100 patients included, 73% had bone disease and 55% received pain relieving medicine. Mean age was 67.7 years (SD 10.3). Patients with multiple myeloma had significantly poorer physical function compared to normative data, both regarding aerobic capacity and muscle strength, although not grip strength. No differences in physical function were found between patients with multiple myeloma and other cancer populations.
CONCLUSIONS


Physical function in newly diagnosed Danish patients with multiple myeloma is lower than in the normal population. Exercise intervention studies are warranted to explore the value of physical exercise on physical function.
TRIAL REGISTRATION


ClinicalTrials.gov, ID NCT02439112, registered 8 May 2015.",2020,"Patients with multiple myeloma had significantly poorer physical function compared to normative data, both regarding aerobic capacity and muscle strength, although not grip strength.","['100 patients newly diagnosed with multiple myeloma', 'Of the 100 patients included, 73% had bone disease and 55% received pain relieving medicine', 'Patients with multiple myeloma', 'patients with multiple myeloma and other cancer populations', 'newly diagnosed Danish patients with multiple myeloma', 'Mean age was 67.7\u2009years (SD 10.3', 'patients newly diagnosed with multiple myeloma', 'newly diagnosed patients with multiple myeloma differs from the reference values of the normal population and other cancer patients']",[],"['Physical function', 'physical function', 'physical function and physical activity levels']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0005940', 'cui_str': 'Disorder of bone'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0010969', 'cui_str': 'Danish language'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517519', 'cui_str': '10.3'}, {'cui': 'C0086715', 'cui_str': 'Normal range'}, {'cui': 'C0205307', 'cui_str': 'Normal'}]",[],"[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0420831,"Patients with multiple myeloma had significantly poorer physical function compared to normative data, both regarding aerobic capacity and muscle strength, although not grip strength.","[{'ForeName': 'Rikke Faebo', 'Initials': 'RF', 'LastName': 'Larsen', 'Affiliation': 'Department of Physiotherapy and Occupational Therapy, Zealand University Hospital, Roskilde, Denmark. rikke.faebo.larsen@rsyd.dk.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Jarden', 'Affiliation': 'Department of Haematology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Lisbeth Rosenbek', 'Initials': 'LR', 'LastName': 'Minet', 'Affiliation': 'Department of Clinical Research, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Ulf Christian', 'Initials': 'UC', 'LastName': 'Frølund', 'Affiliation': 'Department of Haematology, Zealand University Hospital, Roskilde, Denmark.'}, {'ForeName': 'Sören', 'Initials': 'S', 'LastName': 'Möller', 'Affiliation': 'Department of Clinical Research, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Abildgaard', 'Affiliation': 'Department of Clinical Research, University of Southern Denmark, Odense, Denmark.'}]",BMC cancer,['10.1186/s12885-020-6637-6']
2134,33012041,The effect of non-surgical periodontal treatment on gingival crevicular fluid periostin levels in patients with gingivitis and periodontitis.,"OBJECTIVE


The objective of the study was to evaluate the effect of non-surgical periodontal treatment on gingival crevicular fluid (GCF) periostin levels in patients with gingivitis (G) and periodontitis (P).
SUBJECTS AND METHODS


A total of 90 subjects, 30 patients with P, 30 with G, and 30 periodontally healthy (H) subjects were included. Patients with periodontal disease received non-surgical periodontal treatment. GCF periostin levels were assessed at baseline, at the 6th week, and the 3rd month after treatment.
RESULTS


It was found that GCF periostin level was the lowest in the H group (89.31[47.12] pg/30 sec), followed by the G group (132.82[145.14] pg/30 sec), and the highest in the P group (207.75[189.45] pg/30 sec). These differences were statistically significant between H and the other groups (p < .001). After treatment, GCF periostin levels significantly decreased at the 6th week and the 3rd month in the G group, at the 3rd month in the P group compared to baseline values (p < .05).
CONCLUSION


The results of this study suggest that GCF periostin plays a role as a reliable biological marker in the pathogenesis of periodontal disease and non-surgical periodontal treatment is effective in decreasing GCF periostin levels.",2020,"It was found that GCF periostin level was the lowest in the H group (89.31[47.12] pg/30 sec), followed by the G group (132.82[145.14]","['Patients with periodontal disease received non-surgical periodontal treatment', 'patients with gingivitis (G) and periodontitis (P', 'patients with gingivitis and periodontitis', '90 subjects, 30 patients with P, 30 with G, and 30 periodontally healthy (H) subjects were included']",['non-surgical periodontal treatment'],"['GCF periostin levels', 'gingival crevicular fluid (GCF) periostin levels', 'GCF periostin level', 'gingival crevicular fluid periostin levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031090', 'cui_str': 'Periodontal disease'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0017564', 'cui_str': 'Gingival Exudate'}, {'cui': 'C0219433', 'cui_str': 'POSTN protein, human'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",90.0,0.0322563,"It was found that GCF periostin level was the lowest in the H group (89.31[47.12] pg/30 sec), followed by the G group (132.82[145.14]","[{'ForeName': 'Rana', 'Initials': 'R', 'LastName': 'Arslan', 'Affiliation': 'Oral and Dental Health Center, Yozgat, Turkey.'}, {'ForeName': 'Meltem', 'Initials': 'M', 'LastName': 'Karsiyaka Hendek', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Kirikkale University, Kirikkale, Turkey.'}, {'ForeName': 'Ucler', 'Initials': 'U', 'LastName': 'Kisa', 'Affiliation': 'Department of Biochemistry, Faculty of Medicine, Kirikkale University, Kirikkale, Turkey.'}, {'ForeName': 'Ebru', 'Initials': 'E', 'LastName': 'Olgun', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Kirikkale University, Kirikkale, Turkey.'}]",Oral diseases,['10.1111/odi.13664']
2135,33095934,"The effect of rational-emotive education on irrational thinking, subjective wellbeing, and self-efficacy of typically developing students and social acceptance of disabled students.","BACKGROUND


Rational-Emotive Education exercises in mainstream classrooms can be important in eliminating typically developing students' problem behaviors, such as poor acceptance of disabled classmates. This study aimed to assess the effects of Rational-Emotive Education on rational thinking, subjective wellbeing, and self-efficacy of typical students and their levels of social acceptance toward disabled students in mainstream classrooms.
METHOD


The study was conducted between October 25, 2017 and January 17, 2018 at two middle schools located in Ankara, Turkey. A quasi-experimental design and nonequivalent control group were used. The research sample consisted of 212 typically developing students and 16 disabled students in the middle schools. Socio-Demographic Questionnaire, Irrational Beliefs Scale for Adolescents, Adolescent Subjective Wellbeing Scale, General Self-Efficacy Scale, and Social Acceptance Scale were used to collect data. Students in the intervention group participated in a 12-week Rational-Emotive Education program.
RESULTS


The results showed that, for the students who took part in the rational emotive-education program, there was a significant increase in subjective well-being, self-efficacy, and social acceptance towards peers with special needs, and a significant reduction in irrational beliefs as compared to those in the control group (p<.001). Social Validity Questionnaire completed by the parents of the students with special needs to assess the social validity and the effects of the intervention showed that the Rational-Emotive Education program provided a positive classroom atmosphere and so positively affected the disabled students.
CONCLUSION


The study results supported previous findings on Rational-Emotive Education, which is adopted in Turkey and in the world as a humanistic approach. Rational-Emotive Education is a method that can be used in mental and school health nursing to increase social acceptance of the disabled students, eliminate their social-emotional problems, and create a positive classroom atmosphere for all students.",2020,"The results showed that, for the students who took part in the rational emotive-education program, there was a significant increase in subjective well-being, self-efficacy, and social acceptance towards peers with special needs, and a significant reduction in irrational beliefs as compared to those in the control group (p<.001).","['212 typically developing students and 16 disabled students in the middle schools', 'mainstream classrooms', 'typical students and their levels of social acceptance toward disabled students in mainstream classrooms', 'October 25, 2017 and January 17, 2018 at two middle schools located in Ankara, Turkey', 'disabled students']","['Rational-Emotive Education', 'rational-emotive education', 'Rational-Emotive Education program']","['Socio-Demographic Questionnaire, Irrational Beliefs Scale for Adolescents, Adolescent Subjective Wellbeing Scale, General Self-Efficacy Scale, and Social Acceptance Scale', 'irrational thinking, subjective wellbeing, and self-efficacy', 'irrational beliefs', 'Social Validity Questionnaire', 'subjective well-being, self-efficacy, and social acceptance', 'rational thinking, subjective wellbeing, and self-efficacy']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0018576', 'cui_str': 'Handicapped'}, {'cui': 'C0557797', 'cui_str': 'Middle school'}, {'cui': 'C0024500', 'cui_str': 'Mainstreaming (Education)'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0041400', 'cui_str': 'Turkey - country'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0542058', 'cui_str': 'Irrational'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0042283', 'cui_str': 'Validity (Epidemiology)'}]",212.0,0.0131742,"The results showed that, for the students who took part in the rational emotive-education program, there was a significant increase in subjective well-being, self-efficacy, and social acceptance towards peers with special needs, and a significant reduction in irrational beliefs as compared to those in the control group (p<.001).","[{'ForeName': 'Esma', 'Initials': 'E', 'LastName': 'Kabasakal', 'Affiliation': 'Ankara Yıldırım Beyazıt University, Faculty of Health Science.'}, {'ForeName': 'Oya Nuran', 'Initials': 'ON', 'LastName': 'Emiroğlu', 'Affiliation': 'Hacettepe University, Faculty of Nursing.'}]","Child: care, health and development",['10.1111/cch.12819']
2136,33095939,A phase II randomized placebo-controlled trial of pomegranate fruit extract in men with localized prostate cancer undergoing active surveillance.,"INTRODUCTION OR OBJECTIVE


Men with favorable-risk prostate cancer (PCa) on active surveillance may benefit from intervention strategies to slow or prevent disease progression and the need for definitive treatment. Pomegranate and its extracts have shown antiproliferative and proapoptotic effects in cell lines and animal models, but its effect on human prostate cancer as a target tissue remain unclear. Objectives of this trial include pomegranate's ability to alter serum and prostate tissue biomarkers and the ability of an active surveillance cohort to adhere to a chemoprevention trial for 1 year.
METHODS


Men with organ-confined, favorable-risk PCa on AS were randomly assigned to receive pomegranate fruit extract (PFE) 1000 mg (n = 15) or placebo (n = 15) once daily for twelve months. Prostate biopsies were performed at study entry and upon completion of the 1-year intervention. Plasma and urinary biomarkers were analyzed utilizing immunoassays and HPLC. Tissue proteins were assessed by immunohistochemistry (IHC) and measured by automated quantitation.
RESULTS


PFE was well-tolerated with no significant toxicities. One patient withdrew before study initiation and 29 completed the 1-year intervention. No differences in plasma insulin-like growth factor-1 (IGF-1) levels, prostate-specific antigen doubling time, or biopsy kinetics were observed. Metabolites including urolithin A and urolithin A-gluc were detected more frequently in the PFE arm in both urine and plasma (p < .001 and p = .006, respectively). IHC analyses revealed reductions from baseline in 8-OHdG (a DNA damage marker) (p = .01) and androgen receptor expression (p = .04) in prostate tumor associated with PFE treatment.
CONCLUSION


PFE administration for 12-month was well-tolerated and the protocol followed in an active surveillance population. Analyses suggest that PFE contains bioactive compounds capable of altering biomarkers involving oxidative stress and androgen signaling in prostate tumor and normal-appearing adjacent tissue. No alterations in the IGF axis were noted. This finding of study adherence and target activity provides a rationale for the further investigation of PFE in the active surveillance population.",2020,"IHC analyses revealed reductions from baseline in 8-OHdG (a DNA damage marker) (p = .01) and androgen receptor expression (p = .04) in prostate tumor associated with PFE treatment.
","['Men with organ-confined, favorable-risk PCa on AS', 'men with localized prostate cancer undergoing active surveillance', 'Men with favorable-risk prostate cancer (PCa']","['placebo', 'pomegranate fruit extract', 'pomegranate fruit extract (PFE) 1000\u2009mg (n\u2009=\u200915) or placebo', 'PFE']","['Plasma and urinary biomarkers', 'plasma insulin-like growth factor-1 (IGF-1) levels, prostate-specific antigen doubling time, or biopsy kinetics', 'Metabolites including urolithin A and urolithin A-gluc', 'androgen receptor expression', 'IGF axis', '8-OHdG (a DNA damage marker', 'toxicities']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0700325', 'cui_str': 'Patient status observation'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1509685', 'cui_str': 'POMEGRANATE FRUIT EXTRACT'}, {'cui': 'C1883310', 'cui_str': '1000'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0857690', 'cui_str': 'Plasma insulin'}, {'cui': 'C0018284', 'cui_str': 'Growth factor'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0034786', 'cui_str': 'Androgen receptor'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0037657', 'cui_str': 'Somatomedin'}, {'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}, {'cui': 'C0050078', 'cui_str': '8-hydroxy-deoxyguanosine'}, {'cui': 'C0000702', 'cui_str': 'A-DNA'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0040539', 'cui_str': 'TO'}]",,0.202698,"IHC analyses revealed reductions from baseline in 8-OHdG (a DNA damage marker) (p = .01) and androgen receptor expression (p = .04) in prostate tumor associated with PFE treatment.
","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Jarrard', 'Affiliation': 'Department of Urology, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin, USA.'}, {'ForeName': 'Mikolaj', 'Initials': 'M', 'LastName': 'Filon', 'Affiliation': 'Department of Urology, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin, USA.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Huang', 'Affiliation': 'University of Wisconsin Carbone Cancer Center, Madison, Wisconsin, USA.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Havighurst', 'Affiliation': 'Department of Biostatistics and Medical Informatics, University of Wisconsin, Madison, Wisconsin, USA.'}, {'ForeName': 'Katina', 'Initials': 'K', 'LastName': 'DeShong', 'Affiliation': 'University of Wisconsin Carbone Cancer Center, Madison, Wisconsin, USA.'}, {'ForeName': 'KyungMann', 'Initials': 'K', 'LastName': 'Kim', 'Affiliation': 'University of Wisconsin Carbone Cancer Center, Madison, Wisconsin, USA.'}, {'ForeName': 'Badrinath R', 'Initials': 'BR', 'LastName': 'Konety', 'Affiliation': 'Department of Urology, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Saltzstein', 'Affiliation': 'Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin, USA.'}, {'ForeName': 'Hasan', 'Initials': 'H', 'LastName': 'Mukhtar', 'Affiliation': 'University of Wisconsin Carbone Cancer Center, Madison, Wisconsin, USA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Wollmer', 'Affiliation': 'University of Wisconsin Carbone Cancer Center, Madison, Wisconsin, USA.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Suen', 'Affiliation': 'National Cancer Institute, Bethesda, Maryland, USA.'}, {'ForeName': 'Margaret G', 'Initials': 'MG', 'LastName': 'House', 'Affiliation': 'National Cancer Institute, Bethesda, Maryland, USA.'}, {'ForeName': 'Howard L', 'Initials': 'HL', 'LastName': 'Parnes', 'Affiliation': 'National Cancer Institute, Bethesda, Maryland, USA.'}, {'ForeName': 'Howard H', 'Initials': 'HH', 'LastName': 'Bailey', 'Affiliation': 'University of Wisconsin Carbone Cancer Center, Madison, Wisconsin, USA.'}]",The Prostate,['10.1002/pros.24076']
2137,33092331,Effects of different stretching methods on vertical jump ability and range of motion in young female artistic gymnastics athletes.,"BACKGROUND


Female artistic gymnastics includes multiple athletic gestures that can be performed by combining jump strength with wide degrees of joint mobility. The purpose of this study is to examine the effects of two different types of stretching on vertical jump height and range of motion in competitive gymnasts and to identify the most suitable stretching protocol for increasing range of motion, without negatively affecting vertical jump performance.
METHODS


In a crossover design, following dynamic stretching, static stretching, and control (no stretching), eight competitive female gymnasts (age: 14±2 years; BMI: 18.8±1.4 kg/m2, mean±SD) were tested on jump performance through a squat jump, a countermovement jump and an acrobatic gymnastic jump, and on range of motion by measuring the amplitude of the forward oversplit figure.
RESULTS


One-way repeated measure ANOVA revealed significant main, very large effect of stretching condition (p<0.01). Post-hoc comparisons showed improvement of squat jump and countermovement jump after dynamic stretching with respect to static stretching and control (p<0.05). Range of motion increased significantly following static stretching with respect to dynamic stretching and control (p<0.01).
CONCLUSIONS


Dynamic stretching is recommended in the warm-up to increase vertical jump performance, while specific static stretching should be pursued in the final phase of the training session being a specific technical work for range of motion.",2020,Post-hoc comparisons showed improvement of squat jump and countermovement jump after dynamic stretching with respect to static stretching and control (p<0.05).,['young female artistic gymnastics athletes'],"['dynamic stretching, static stretching, and control (no stretching', 'jump performance through a squat jump, a countermovement jump and an acrobatic gymnastic jump, and on range of motion by measuring the amplitude of the forward oversplit figure', 'stretching methods']","['squat jump and countermovement jump', 'vertical jump ability and range of motion']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0018409', 'cui_str': 'Gymnastics'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C1720875', 'cui_str': 'Static Stretching'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0018409', 'cui_str': 'Gymnastics'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439780', 'cui_str': 'Forward'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}]",8.0,0.0152856,Post-hoc comparisons showed improvement of squat jump and countermovement jump after dynamic stretching with respect to static stretching and control (p<0.05).,"[{'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Melocchi', 'Affiliation': 'Department of Biomedical Sciences for Health, Università degli Studi di Milano, Milan, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Filipas', 'Affiliation': 'Department of Biomedical Sciences for Health, Università degli Studi di Milano, Milan, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Lovecchio', 'Affiliation': 'Department of Biomedical Sciences for Health, Università degli Studi di Milano, Milan, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'De Nardi', 'Affiliation': 'Krioplanet Ltd, Treviglio, Bergamo, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'La Torre', 'Affiliation': 'Department of Biomedical Sciences for Health, Università degli Studi di Milano, Milan, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Codella', 'Affiliation': 'Department of Biomedical Sciences for Health, Università degli Studi di Milano, Milan, Italy - roberto.codella@unimi.it.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.20.11386-0']
2138,33092399,Reduced fluence corneal cross-linking in mild to moderate keratoconus: One year-follow-up.,"PURPOSE


To evaluate the safety and efficacy of reduced fluence CXL (lower dose of UV-A irradiation) in mild to moderate keratoconus.
SETTING


Farabi Eye Hospital, Tehran, Iran.
DESIGN


Non-randomized prospective comparative interventional case series. Every eligible patient included in the study (mild to moderate progressive keratoconus) was randomly allocated to case (reduced fluence) and control (standard) groups, except for bilateral patients. In these patients the eye with more advanced disease was allocated to control group and the other eye was randomly assigned in either case or control group. Operators performing refraction and images and the data analyst were masked, but patients and physicians were not.
METHODS


Forty-six eyes of 38 patients were recruited. Group 1 received 7 min (fluence of 3.8 J/cm 2 ), while group 2 received 10 min of 9 mW/cm 2  UV-A (fluence of 5.4 J/cm 2 ). Visual, keratometric and biomechanical outcomes were compared between groups.
RESULTS


At last follow-up (mean12 months, range 6-24 months), there were no statistically significant differences in changes in uncorrected visual acuity, best corrected distance visual acuity, Kmax, Kmean, corneal hysteresis, corneal resistance factor, endothelial cell counts, demarcation line depth, and intraoperative pain scores between groups (all  p -values < 0.05).
CONCLUSION


The results of this study show comparable one-year outcomes between 3.8 and 5.4 J/cm 2  accelerated CXL in mild to moderate keratoconus. Should the results of this study be confirmed in longer follow-ups, using a reduced fluence setting could be considered as an alternative to standard treatment in these patients.",2020,"At last follow-up (mean12 months, range 6-24 months), there were no statistically significant differences in changes in uncorrected visual acuity, best corrected distance visual acuity, Kmax, Kmean, corneal hysteresis, corneal resistance factor, endothelial cell counts, demarcation line depth, and intraoperative pain scores between groups (all  p -values < 0.05).
","['mild to moderate keratoconus', 'Every eligible patient included in the study (mild to moderate progressive keratoconus', 'Farabi Eye Hospital, Tehran, Iran.\nDESIGN', 'Forty-six eyes of 38 patients were recruited']","['reduced fluence CXL', '10\u2009min of 9\u2009mW/cm 2', 'UV-A irradiation']","['uncorrected visual acuity, best corrected distance visual acuity, Kmax, Kmean, corneal hysteresis, corneal resistance factor, endothelial cell counts, demarcation line depth, and intraoperative pain scores', 'safety and efficacy', 'Visual, keratometric and biomechanical outcomes']","[{'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0022578', 'cui_str': 'Keratoconus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}]","[{'cui': 'C1637380', 'cui_str': 'Uncorrected visual acuity'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity'}, {'cui': 'C0034471', 'cui_str': 'R factor'}, {'cui': 'C0429518', 'cui_str': 'Endothelial cell density'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",38.0,0.113695,"At last follow-up (mean12 months, range 6-24 months), there were no statistically significant differences in changes in uncorrected visual acuity, best corrected distance visual acuity, Kmax, Kmean, corneal hysteresis, corneal resistance factor, endothelial cell counts, demarcation line depth, and intraoperative pain scores between groups (all  p -values < 0.05).
","[{'ForeName': 'Seyed Reza', 'Initials': 'SR', 'LastName': 'Ghaffari', 'Affiliation': 'Eye Research Center, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Khaheshi', 'Affiliation': 'Eye Research Center, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Fateme', 'Initials': 'F', 'LastName': 'Alipour', 'Affiliation': 'Eye Research Center, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Somayye', 'Initials': 'S', 'LastName': 'Mashhadi Farahani', 'Affiliation': 'Eye Research Center, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Amir-Hooshang', 'Initials': 'AH', 'LastName': 'Beheshtnejad', 'Affiliation': 'Eye Research Center, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Farhad', 'Initials': 'F', 'LastName': 'Hafezi', 'Affiliation': 'Department of Ophthalmology, Geneva University Hospitals, Geneva, Switzerland.'}]",European journal of ophthalmology,['10.1177/1120672120966560']
2139,33092401,Efficacy of MAVIG X-Ray Protective Drapes in Reducing Operator Radiation Dose in the Cardiac Catheterization Laboratory: A Randomized Controlled Trial.,"BACKGROUND


Interventional cardiologists are occupationally exposed to high doses of ionizing radiation. The MAVIG X-ray protective drape (MXPD) is a commercially available light weight, lead-free shield placed over the pelvic area of patients to minimize operator radiation dose. The aim of this study was to examine the efficacy of the MXPD during routine cardiac catheterization, including percutaneous coronary interventions.
METHODS


We performed a prospective, randomized controlled study comparing operator radiation dose during cardiac catheterization and percutaneous coronary intervention (n=632) with or without pelvic MXPD. We measured operator radiation dose at 4 sites: left eye, chest, left ring finger, and right ring finger. The primary outcomes were the difference in first operator radiation dose (µSv) and relative dose of the first operator (radiation dose normalized for dose area product) at the level of the chest in the 2 groups.
RESULTS


The use of the MXPD was associated with a 50% reduction in operator radiation dose (median dose 30.5 [interquartile range, 23.0-39.7] µSv in no drape group versus 15.3 [interquartile range, 11.1-20.0] µSv in the drape group;  P <0.001) and a 57% reduction in relative operator dose ( P <0.001). The largest absolute reduction in dose was observed at the left finger (median left finger dose for the no drape group was 104.9 [75.7-137.4] µSv versus 41.9 [32.6-70.6] µSv in the drape group;  P <0.001).
CONCLUSIONS


The pelvic MXPD significantly reduces first operator radiation dose during routine cardiac catheterization and percutaneous coronary intervention.
REGISTRATION


URL: https://www.clinicaltrials.gov. Unique identifier: NCT04285944.",2020,The largest absolute reduction in dose was observed at the left finger (median left finger dose for the no drape group was 104.9 [75.7-137.4],['Cardiac Catheterization Laboratory'],"['MXPD', 'MAVIG X-Ray Protective Drapes', 'MAVIG X-ray protective drape (MXPD', 'operator radiation dose during cardiac catheterization and percutaneous coronary intervention (n=632) with or without pelvic MXPD']",['difference in first operator radiation dose (µSv) and relative dose of the first operator (radiation dose normalized for dose area product) at the level of the chest'],"[{'cui': 'C0018795', 'cui_str': 'Cardiac catheterization'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}]","[{'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0018795', 'cui_str': 'Cardiac catheterization'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}]","[{'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}]",632.0,0.0679716,The largest absolute reduction in dose was observed at the left finger (median left finger dose for the no drape group was 104.9 [75.7-137.4],"[{'ForeName': 'Keir', 'Initials': 'K', 'LastName': 'McCutcheon', 'Affiliation': 'Department of Cardiovascular Diseases, University Hospitals Leuven, Belgium (K.M., M.V., R.P., J.B., T.A., C.D., P.S., W.D.).'}, {'ForeName': 'Maarten', 'Initials': 'M', 'LastName': 'Vanhaverbeke', 'Affiliation': 'Department of Cardiovascular Diseases, University Hospitals Leuven, Belgium (K.M., M.V., R.P., J.B., T.A., C.D., P.S., W.D.).'}, {'ForeName': 'Ruben', 'Initials': 'R', 'LastName': 'Pauwels', 'Affiliation': 'Department of Cardiovascular Diseases, University Hospitals Leuven, Belgium (K.M., M.V., R.P., J.B., T.A., C.D., P.S., W.D.).'}, {'ForeName': 'Jérémie', 'Initials': 'J', 'LastName': 'Dabin', 'Affiliation': 'Belgian Nuclear Research Centre, Research in Dosimetric Applications, Mol, Belgium (J.D., W.S.).'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Schoonjans', 'Affiliation': 'Belgian Nuclear Research Centre, Research in Dosimetric Applications, Mol, Belgium (J.D., W.S.).'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Bennett', 'Affiliation': 'Department of Cardiovascular Diseases, University Hospitals Leuven, Belgium (K.M., M.V., R.P., J.B., T.A., C.D., P.S., W.D.).'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Adriaenssens', 'Affiliation': 'Department of Cardiovascular Diseases, University Hospitals Leuven, Belgium (K.M., M.V., R.P., J.B., T.A., C.D., P.S., W.D.).'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Dubois', 'Affiliation': 'Department of Cardiovascular Diseases, University Hospitals Leuven, Belgium (K.M., M.V., R.P., J.B., T.A., C.D., P.S., W.D.).'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Sinnaeve', 'Affiliation': 'Department of Cardiovascular Diseases, University Hospitals Leuven, Belgium (K.M., M.V., R.P., J.B., T.A., C.D., P.S., W.D.).'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Desmet', 'Affiliation': 'Department of Cardiovascular Diseases, University Hospitals Leuven, Belgium (K.M., M.V., R.P., J.B., T.A., C.D., P.S., W.D.).'}]",Circulation. Cardiovascular interventions,['10.1161/CIRCINTERVENTIONS.120.009627']
2140,33092617,Pulp repair response after the use of a dentin-pulp biostimulation membrane (BBio) in primary teeth: study protocol for a randomized clinical trial.,"BACKGROUND


Vital pulp therapy aims at maintaining the pulp tissue injured but vital. Thus, the use of capping materials that induce tissue regeneration is a great current trend. This study aims to evaluate clinically and radiographically the pulp repair after the use of dentin-pulp biostimulation membrane in primary teeth.
METHODS


Four hundred and sixty-eight teeth from children aged between 5 and 9 years old, both genders, with deep caries lesion with pulp involvement, but no furcal impairment and any sign of necrosis will be selected. The vital pulp therapy will be performed with mineral trioxide aggregate (control group) and dentin-pulp biostimulation chitosan membrane (BBio group). The clinical and radiographic outcomes will be assessed at 12 and 24 months after treatment. The thickness of the dentin barrier will be verified through Image J2 software. The Wilcoxon signed rank test and Mann-Whitney test will respectively compare the intra- and intergroup clinical and radiographic outcomes. Paired t test and independent t test will respectively compare the intra- and intergroup radiographic measurements. The logistic regression will be applied, and the degrees of this association will be measured using odds ratio (OR) and 95% confidence interval (95% CI).
DISCUSSION


Therefore, this study protocol aims at new perspectives of vital pulp therapy of primary teeth by employing new easy-handling, low-cost material to keep viable the pulp tissue capable of regenerating and maintain the physiological process of deciduous tooth exfoliation.
TRIAL REGISTRATION


Brazilian Registry of Clinical Trials RBR-6vr58b . Registered on 17 February 2019.",2020,The vital pulp therapy will be performed with mineral trioxide aggregate (control group) and dentin-pulp biostimulation chitosan membrane (BBio group).,"['Four hundred and sixty-eight teeth from children aged between 5 and 9\u2009years old, both genders, with deep caries lesion with pulp involvement, but no furcal impairment and any sign of necrosis will be selected', 'primary teeth']","['dentin-pulp biostimulation membrane', 'dentin-pulp biostimulation membrane (BBio', 'mineral trioxide aggregate (control group) and dentin-pulp biostimulation chitosan membrane (BBio group']",['Pulp repair response'],"[{'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0450387', 'cui_str': '68'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0333523', 'cui_str': 'Deep caries'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0011399', 'cui_str': 'Structure of pulp of tooth'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0027540', 'cui_str': 'Necrosis'}, {'cui': 'C3266841', 'cui_str': 'All deciduous teeth'}]","[{'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0011399', 'cui_str': 'Structure of pulp of tooth'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0253527', 'cui_str': 'mineral trioxide aggregate'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0162969', 'cui_str': 'Chitosan'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0011399', 'cui_str': 'Structure of pulp of tooth'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}]",,0.0788306,The vital pulp therapy will be performed with mineral trioxide aggregate (control group) and dentin-pulp biostimulation chitosan membrane (BBio group).,"[{'ForeName': 'Maria Aparecida Andrade Moreira', 'Initials': 'MAAM', 'LastName': 'Machado', 'Affiliation': 'Department of Pediatric Dentistry, Orthodontics and Public Health, School of Dentistry of Bauru, University of São Paulo, Bauru, São Paulo, Brazil.'}, {'ForeName': 'Tássia Carina', 'Initials': 'TC', 'LastName': 'Stafuzza', 'Affiliation': 'Department of Pediatric Dentistry, Orthodontics and Public Health, School of Dentistry of Bauru, University of São Paulo, Bauru, São Paulo, Brazil.'}, {'ForeName': 'Luciana Lourenço Ribeiro', 'Initials': 'LLR', 'LastName': 'Vitor', 'Affiliation': 'Department of Pediatric Dentistry, Orthodontics and Public Health, School of Dentistry of Bauru, University of São Paulo, Bauru, São Paulo, Brazil.'}, {'ForeName': 'Silgia Aparecida', 'Initials': 'SA', 'LastName': 'da Costa', 'Affiliation': 'Course on Textiles and Fashion, School of Arts, Sciences and Humanities, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Sirlene Maria', 'Initials': 'SM', 'LastName': 'da Costa', 'Affiliation': 'Course on Textiles and Fashion, School of Arts, Sciences and Humanities, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Natalino Lourenço', 'Initials': 'NL', 'LastName': 'Neto', 'Affiliation': 'Department of Pediatric Dentistry, Orthodontics and Public Health, School of Dentistry of Bauru, University of São Paulo, Bauru, São Paulo, Brazil.'}, {'ForeName': 'Thais Marchini', 'Initials': 'TM', 'LastName': 'Oliveira', 'Affiliation': 'Department of Pediatric Dentistry, Orthodontics and Public Health, School of Dentistry of Bauru, University of São Paulo, Bauru, São Paulo, Brazil. marchini@usp.br.'}]",Trials,['10.1186/s13063-020-04785-2']
2141,33092618,"Respiratory support in COPD patients after acute exacerbation with monitoring the quality of support (Rescue2-monitor): an open-label, prospective randomized, controlled, superiority clinical trial comparing hospital- versus home-based acute non-invasive ventilation for patients with hypercapnic chronic obstructive pulmonary disease.","Chronic obstructive pulmonary disease (COPD) is expected to be the 3 rd  leading cause of death worldwide by 2020. Despite improvements in survival by using acute non-invasive ventilation (NIV) to treat patients with exacerbations of COPD complicated by acute hypercapnic respiratory failure (AHRF), these patients are at high risk of readmission and further life-threatening events, including death. Recent studies suggested that NIV at home can reduce readmissions, but in a small proportion of patients, and with a high level of expertise. Other studies, however, do not show any benefit of home NIV. This could be related to the fact that respiratory failure in patients with stable COPD and their response to mechanical ventilation are influenced by several pathophysiological factors which frequently coexist in the same patient to varying degrees. These pathophysiological factors might influence the success of home NIV in stable COPD, thus long-term NIV specifically adapted to a patient's ""phenotype"" is likely to improve prognosis, reduce readmission to hospital, and prevent death. In view of this conundrum, Rescue2-monitor (R2M), an open-label, prospective randomized, controlled study performed in patients with hypercapnic COPD post-AHRF, will investigate the impact of the quality of nocturnal NIV on the readmission-free survival. The primary objective is to show that any of 3 home NIV strategies (""rescue,"" ""non-targeted,"" and ""targeted"") will improve readmission-free survival in comparison to no-home NIV. The ""targeted"" group of patients will receive a treatment with personalized (targeted) ventilation settings and extensive monitoring. Furthermore, the influence of comorbidities typical for COPD patients, such as cardiac insufficiency, OSA, or associated asthma, on ventilation outcomes will be taken into consideration and reasons for non-inclusion of patients will be recorded in order to evaluate the percentage of ventilated COPD patients that are screening failures. ClinicalTrials.gov NCT03890224 . Registered on March 26, 2019.",2020,"Despite improvements in survival by using acute non-invasive ventilation (NIV) to treat patients with exacerbations of COPD complicated by acute hypercapnic respiratory failure (AHRF), these patients are at high risk of readmission and further life-threatening events, including death.","['COPD patients after acute exacerbation with monitoring the quality of support (Rescue2-monitor', 'patients with hypercapnic chronic obstructive pulmonary disease', 'patients with exacerbations of COPD complicated by acute hypercapnic respiratory failure (AHRF', 'Chronic obstructive pulmonary disease (COPD', 'patients with stable COPD', 'patients with hypercapnic COPD post-AHRF']","['hospital- versus home-based acute non-invasive ventilation', 'personalized (targeted) ventilation settings and extensive monitoring', '3 home NIV strategies (""rescue,"" ""non-targeted,"" and ""targeted']",['survival'],"[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0020440', 'cui_str': 'Hypercapnia'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}, {'cui': 'C4040419', 'cui_str': 'Acute hypercapnic respiratory failure'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0687676', 'cui_str': 'After values'}]","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0205231', 'cui_str': 'Extensive'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0751673', 'cui_str': 'Nipah virus'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.057771,"Despite improvements in survival by using acute non-invasive ventilation (NIV) to treat patients with exacerbations of COPD complicated by acute hypercapnic respiratory failure (AHRF), these patients are at high risk of readmission and further life-threatening events, including death.","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-020-04672-w']
2142,33092632,"""Early transfusion of convalescent plasma in older patients with COVID-19 to prevent disease progression: A structured summary of a study protocol for a randomised controlled trial"".","OBJECTIVES


The primary objective is to demonstrate that COVID-19 convalescent plasma (CCP) prevents progression to severe pneumonia in elderly COVID-19 pneumonia patients with chronic comorbidities. Secondary objectives are to demonstrate that CCP decreases the viral load in nasopharyngeal swabs and increases the anti-SARS-CoV-2 antibody titre in recipients.
TRIAL DESIGN


This is a randomized, open-label, parallel group, phase II/III study with a superiority framework. The trial starts with a screening phase II designed with two-tailed alpha=0.2. In case of positive results, the trial will proceed in a formally comparative phase III (alpha=0.05).
PARTICIPANTS


Adult patients with confirmed or suspected COVID-19 who are at risk according to CDC definition are eligible. Inclusion criteria are all the following: age ≥ 65; pneumonia at CT scan; PaO2/FiO2 ≥300 mmHg; presence of one or more comorbidities; signed informed consent. Exclusion criteria are one of the following: age < 65; PaO2/FiO2 < 300 mmHg; pending cardiopulmonary arrest; refusal to blood product transfusions; severe IgA deficiency; any life-threatening comorbidity or any other medical condition which, in the opinion of the investigator, makes the patient unsuitable for inclusion. The trial is being conducted at three reference COVID-19 centres in the middle of Italy.
INTERVENTION AND COMPARATOR


Intervention: COVID-19 Convalescent Plasma (CCP) in addition to standard therapy. Patients receive three doses (200 ml/day on 3 consecutive days) of ABO matched CCP. Comparator: Standard therapy MAIN OUTCOMES: A. Primary outcome for Phase II: Proportion of patients without progression in severity of pulmonary disease, defined as worsening of 2 points in the ordinal scale of WHO by day 14. B. Primary outcome for Phase III: Proportion of patients without progression in severity of pulmonary disease, defined as worsening of 2 points in the ordinal scale of WHO by day 14. Secondary outcomes for Phase III: Decreased viral load on nasopharyngeal swab at days 6, 9 and 14; Decreased viremia at days 6 and 9; Increased antibody titer against SARS-CoV2 at days 30 and 60; Proportion of patients with negative of SARS-CoV2 nasopharyngeal swab at day 30; Length of hospital stay; Mortality rate at day 28; Total plasma related adverse event (day 60); Total non-plasma related adverse events (day 60); Severe adverse events (SAE) (day 60).
RANDOMISATION


Treatment allocation is randomized with a ratio 1:1 in both phase II and phase III. Randomization sequences will be generated at Fondazione Policlinico Gemelli IRCCS through the RedCap web application. Randomized stratification is performed according to age (under/over 80 years), and sex.
BLINDING (MASKING)


None, this is an open-label trial.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)


Phase II: 114 patients (57 per arm). Phase III: 182 patients (91 per arm) TRIAL STATUS: The trial recruitment started on May 27, 2020. The anticipated date of recruitment completion is April 30, 2021. The protocol version is 2 (May 10, 2020).
TRIAL REGISTRATION


The trial has been registered on ClinicalTrials.gov (May 5, 2020). The Identifier number is NCT04374526 FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,"Decreased viral load on nasopharyngeal swab at days 6, 9 and 14; Decreased viremia at days 6 and 9; Increased antibody titer against SARS-CoV2 at days 30 and 60; Proportion of patients with negative of SARS-CoV2 nasopharyngeal swab at day 30; Length of hospital stay; Mortality rate at day 28; Total plasma related adverse event (day 60); Total non-plasma related adverse events (day 60); Severe adverse events (SAE) (day 60).
","['older patients with COVID-19 to prevent disease progression', 'Exclusion criteria are one of the following: age < 65; PaO2/FiO2 < 300 mmHg; pending cardiopulmonary arrest; refusal to blood product transfusions; severe IgA deficiency; any life-threatening comorbidity or any other medical condition which, in the opinion of the investigator, makes the patient unsuitable for inclusion', 'elderly COVID-19 pneumonia patients with chronic comorbidities', 'age (under/over 80 years), and sex', 'Phase III: 182 patients (91 per arm', 'Inclusion criteria are all the following: age ≥ 65; pneumonia at CT scan; PaO2/FiO2 ≥300 mmHg; presence of one or more comorbidities; signed informed consent', 'Adult patients with confirmed or suspected COVID-19 who are at risk according to CDC definition are eligible']","['Comparator', 'COVID-19 convalescent plasma (CCP', 'CCP']","['Phase II: Proportion of patients without progression in severity of pulmonary disease, defined as worsening of 2 points in the ordinal scale of WHO', 'viral load in nasopharyngeal swabs and increases the anti-SARS-CoV-2 antibody titre', 'COVID-19 Convalescent Plasma (CCP', 'viremia', 'hospital stay; Mortality rate', 'Phase III: Proportion of patients without progression in severity of pulmonary disease, defined as worsening of 2 points in the ordinal scale of WHO', 'antibody titer against SARS-CoV2']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0600228', 'cui_str': 'Cardiorespiratory arrest'}, {'cui': 'C0040809', 'cui_str': 'Refusal of treatment by patient'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0162538', 'cui_str': 'Immunoglobulin A deficiency'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0034030', 'cui_str': 'Public Opinion'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0007670', 'cui_str': 'Centers for Disease Control and Prevention (U.S.)'}, {'cui': 'C3539107', 'cui_str': 'Definition'}]","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0740326', 'cui_str': 'Convalescent'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}]","[{'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0024115', 'cui_str': 'Disorder of lung'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0444192', 'cui_str': 'Nasopharyngeal swab'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0474643', 'cui_str': 'Antibody titer measurement'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0740326', 'cui_str': 'Convalescent'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0042749', 'cui_str': 'Viremia'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0439070', 'cui_str': 'III'}]",,0.130479,"Decreased viral load on nasopharyngeal swab at days 6, 9 and 14; Decreased viremia at days 6 and 9; Increased antibody titer against SARS-CoV2 at days 30 and 60; Proportion of patients with negative of SARS-CoV2 nasopharyngeal swab at day 30; Length of hospital stay; Mortality rate at day 28; Total plasma related adverse event (day 60); Total non-plasma related adverse events (day 60); Severe adverse events (SAE) (day 60).
","[{'ForeName': 'Luciana', 'Initials': 'L', 'LastName': 'Teofili', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy. luciana.teofili@unicatt.it.'}, {'ForeName': 'Raffaele', 'Initials': 'R', 'LastName': 'Landolfi', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.'}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Cingolani', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Antinori', 'Affiliation': 'Istituto Nazionale Malattie Infettive Lazzaro Spallanzani IRCCS, Rome, Italy.'}, {'ForeName': 'Jacopo', 'Initials': 'J', 'LastName': 'Vecchiet', 'Affiliation': 'Presidio Ospedaliero S.S. Annunziata, ASL Lanciano -Vasto-Chieti, Università di Chieti, Chieti, Italy.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Sanguinetti', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Gasbarrini', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Pasciuto', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.'}, {'ForeName': 'Nicoletta', 'Initials': 'N', 'LastName': 'Orlando', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Lamonica', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.'}]",Trials,['10.1186/s13063-020-04821-1']
2143,33092653,The clinical effect of Nano micelles containing curcumin as a therapeutic supplement in patients with COVID-19 and the immune responses balance changes following treatment: A structured summary of a study protocol for a randomised controlled trial.,"OBJECTIVES


To investigates the effectiveness of curcumin-containing Nanomicelles as a therapeutic supplement in the treatment of patients with COVID-19 and its effect on immune responses balance changes following treatment.
TRIAL DESIGN


This study is conducted as a prospective, placebo-controlled with parallel group, single-center randomized clinical trial on COVID-19 patients.
PARTICIPANTS


Patients are selected from the COVID-19 ward of Shahid Mohammadi Hospital in Bandar Abbas, Iran.
INCLUSION CRITERIA


1. Real time PCR-approved positive COVID-19 test. 2. Both gender 3. Age between 18 and 75 years 4. Signing a written consent 5. Lack of participation in other clinical trials Exclusion criteria: 1. Pregnancy or lactation 2. Allergy to turmeric or curcumin 3. Smoking 4. Patient connected to the ventilator 5. SaO2 less than 90% or PaO2 less than 8 kPa 6. Having comorbidities (such as severe renal failure, Glomerular filtration rate less than 30 ml/min, liver failure, Congestive heart failure, or Chronic obstructive pulmonary disease) 7. History of gallstones 8. History of gastritis or active gastrointestinal ulcer INTERVENTION AND COMPARATOR: In addition to the routine standard treatments for COVID-19, in the intervention group, 40mg nanomicelles containing curcumin (SinaCurcumin Capsule, Exir Nano Sina Company, Iran), four times per day (after breakfast, lunch, dinner and before bedtime) and in the placebo group as the control group, capsules with the same appearance and characteristics (Placebo capsules, Exir Nano Sina Company, Iran) are prescribed for two weeks.
MAIN OUTCOMES


The effectiveness of Nano micelles containing curcumin treatment will be evaluated as daily clinical examinations of patients in both groups and, on days 0, 7 and 14, complete clinical symptoms and laboratory findings including peripheral blood and serum parameters such as inflammatory markers will be measured and recorded. Moreover, in order to evaluate the balance of immune responses changes following treatments, serum level of IFN-γ, IL-17, Il-4 and TGF-β serum cytokines will be measured in both groups at time points of 0, 7 and 14 days post treatment. Gene expression of t-bet, GATA-3, FoxP3 and ROR- γT will also be measured at mentioned time points to assess the shift of T helper1, T helper2, T regulatory and T helper 17 immune responses following treatment.
RANDOMISATION


Randomized trials will be performed on 40 COVID-19 patients which will be randomized using encoded sealed boxes with computer generated random digits with 1:1 allocation ratio. In order to randomization, placebo and SinaCurcumin Capsules will be numbered first by computer generated random digits. SinaCurcumin and placebo will then be stored and numbered in sealed packages based on generated random numbers. Finally, according to the order in which patients enter the study, packages are given to patients based on their number.
BLINDING (MASKING)


The present study will be blind for all patients, physicians and nurses, laboratory technicians and statisticians.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)


A total of 40 patients will be included in the study, 20 of them will be randomly assigned to the intervention group and 20 to the placebo group.
TRIAL STATUS


This is Version 1.0 of protocol dated 21 May 2020. The recruitment was started June 24, 2020 and is expected to be completed by October 31, 2020.
TRIAL REGISTRATION


This present clinical trial has been registered in the Iranian Registry of Clinical Trials (IRCT) with the registration code of ""IRCT20200611047735N1"", https://www.irct.ir/trial/48843 . Dated: 19 June 2020.
FULL PROTOCOL


The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,"Gene expression of t-bet, GATA-3, FoxP3 and ROR- γT will also be measured at mentioned time points to assess the shift of T helper1, T helper2, T regulatory and T helper 17 immune responses following treatment.
","['patients with COVID-19 and the immune responses balance changes following treatment', 'Having comorbidities (such as severe renal failure, Glomerular filtration rate less than 30 ml/min, liver failure, Congestive heart failure, or Chronic obstructive pulmonary disease) 7', '40 patients', 'all patients, physicians and nurses, laboratory technicians and statisticians', '40 COVID-19 patients', 'COVID-19 patients', 'Patients are selected from the COVID-19 ward of Shahid Mohammadi Hospital in Bandar Abbas, Iran', 'Age between 18 and 75 years 4']","['SinaCurcumin and placebo', 'placebo', 'curcumin-containing Nanomicelles', 'control group, capsules with the same appearance and characteristics (Placebo capsules, Exir Nano Sina Company, Iran', 'placebo and SinaCurcumin Capsules']","['Gene expression of t-bet, GATA-3, FoxP3 and ROR- γT', 'serum level of IFN-γ, IL-17, Il-4 and TGF-β serum cytokines']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0301872', 'cui_str': 'Immune response'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C0085605', 'cui_str': 'Hepatic failure'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0086517', 'cui_str': 'Laboratory technician'}, {'cui': 'C0334957', 'cui_str': 'Statistician'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0016995', 'cui_str': 'Gambling'}, {'cui': 'C1307598', 'cui_str': 'GATA3 protein, human'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0384648', 'cui_str': 'Interleukin 17'}, {'cui': 'C0021758', 'cui_str': 'Interleukin-4'}, {'cui': 'C0040691', 'cui_str': 'Transforming Growth Factor'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}]",40.0,0.354737,"Gene expression of t-bet, GATA-3, FoxP3 and ROR- γT will also be measured at mentioned time points to assess the shift of T helper1, T helper2, T regulatory and T helper 17 immune responses following treatment.
","[{'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Hassaniazad', 'Affiliation': 'Infectious and Tropical Diseases Research Center, Hormozgan Health Institute, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Behnaz Rahnama', 'Initials': 'BR', 'LastName': 'Inchehsablagh', 'Affiliation': 'Student Research Committee, Faculty of Medicine, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Kamali', 'Affiliation': 'Student Research Committee, Faculty of Medicine, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Abdolali', 'Initials': 'A', 'LastName': 'Tousi', 'Affiliation': 'Student Research Committee, Faculty of Medicine, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Ebrahim', 'Initials': 'E', 'LastName': 'Eftekhar', 'Affiliation': 'Endocrinology and Metabolism Research Center, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Mahmoud Reza', 'Initials': 'MR', 'LastName': 'Jaafari', 'Affiliation': 'Nanotechnology Research Center, Pharmaceutical Technology Institute, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Fathalipour', 'Affiliation': 'Endocrinology and Metabolism Research Center, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Nikoofal-Sahlabadi', 'Affiliation': 'Department of Pharmaceutics, Faculty of Pharmacy, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Gouklani', 'Affiliation': 'Infectious and Tropical Diseases Research Center, Hormozgan Health Institute, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Hesam', 'Initials': 'H', 'LastName': 'Alizade', 'Affiliation': 'Infectious and Tropical Diseases Research Center, Hormozgan Health Institute, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Amin Reza', 'Initials': 'AR', 'LastName': 'Nikpoor', 'Affiliation': 'Molecular Medicine Research Center, Hormozgan Health Institute, Hormozgan University of Medical Sciences, Bandar Abbas, Iran. nikpoora@hums.ac.ir.'}]",Trials,['10.1186/s13063-020-04824-y']
2144,33092901,Endoscopic intragastric injection of botulinum toxin A in obese patients on bariatric surgery waiting lists: A randomised double-blind study (IntraTox study).,"BACKGROUND & AIMS


Several studies have evaluated the effect of intragastric injection of botulinum toxin A to treat obesity, achieving mixed results. Our objective is to determine the effect of intragastric botulinum toxin A on weight loss, satiety, biomarkers, and quality of life of obese patients prior bariatric surgery.
METHODS


Design: single-centre, randomised, double-blind, placebo-controlled clinical trial in 52 obese patients on bariatric surgery waiting lists. Two-arm parallel: the treatment group was administered intragastric botulinum toxin A by endoscopy, whereas the control group was administered physiological saline solution. Weight loss was evaluated at weeks 2, 4, 8, 16, and 24, as well as changes in body composition, satiety (Visual analogue scale (VAS) and GCSI questionnaire), quality of life (GIQLI questionnaire), and biomarkers of satiety and appetite.
RESULTS


Weight loss at weeks 2, 4, 8, 16, and 24 after the endoscopy, with respect to the basal visit, was 0.6 ± 2 kg, 0.4 ± 2.7 kg, 0.4 ± 3.1 kg, 0.2 ± 4.5 kg, and 0.6 ± 4.3 kg for the control group vs 1.9 ± 2.1 kg, 2 ± 2.6 kg, 2.8 ± 4.1 kg, 3.5 ± 5.3 kg, and 4.5 ± 7 kg for the treatment group, respectively, being differences between groups significant at all times (p = 0.016, 0.031, 0.014, 0.021, and 0.023, respectively). Treatment group patients obtained a significantly higher score for GIQLI questionnaire compared with baseline (104.4 ± 13.9 points vs 97.7 ± 15.6 points; p = 0.024), showing a significant improvement in the section of subjective physical capacity. No significant differences were found regarding perception of satiety, or biomarkers of satiety and appetite.
CONCLUSIONS


Intragastric injection of botulinum toxin A is an effective and safe procedure to achieve a moderate weight loss and improve quality of life. Registered under clinicaltrialsregister.eu Identifier EudraCT number 2015-004391-29 https://www.clinicaltrialsregister.eu/ctr-search/trial/2015-004391-29/ES.",2020,"Treatment group patients obtained a significantly higher score for GIQLI questionnaire compared with baseline (104.4 ± 13.9 points vs 97.7 ± 15.6 points; p = 0.024), showing a significant improvement in the section of subjective physical capacity.","['52 obese patients on bariatric surgery waiting lists', 'obese patients on bariatric surgery', 'obese patients prior bariatric surgery']","['botulinum toxin', 'botulinum toxin A', 'intragastric botulinum toxin', 'intragastric botulinum toxin A by endoscopy, whereas the control group was administered physiological saline solution', 'placebo', 'Endoscopic intragastric injection of botulinum toxin A']","['weight loss, satiety, biomarkers, and quality of life', 'moderate weight loss and improve quality of life', 'perception of satiety, or biomarkers of satiety and appetite', 'section of subjective physical capacity', 'score for GIQLI questionnaire', 'Weight loss', 'body composition, satiety (Visual analogue scale (VAS) and GCSI questionnaire), quality of life (GIQLI questionnaire), and biomarkers of satiety and appetite']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0332152', 'cui_str': 'Before'}]","[{'cui': 'C0006055', 'cui_str': 'botulinum toxin'}, {'cui': 'C0006050', 'cui_str': 'Botulinum Toxin Type A'}, {'cui': 'C0442113', 'cui_str': 'Intragastric'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1321035', 'cui_str': 'Injection of botulinum toxin'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0036239', 'cui_str': 'Satiety'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0967114', 'cui_str': 'goblet cell silencer inhibitor'}]",52.0,0.19083,"Treatment group patients obtained a significantly higher score for GIQLI questionnaire compared with baseline (104.4 ± 13.9 points vs 97.7 ± 15.6 points; p = 0.024), showing a significant improvement in the section of subjective physical capacity.","[{'ForeName': 'Francisco José', 'Initials': 'FJ', 'LastName': 'Sánchez Torralvo', 'Affiliation': 'UGC Endocrinología y Nutrición, Hospital Regional Universitario de Málaga, Plaza del Hospital Civil, S/N, 29009, Málaga, Spain; Universidad de Málaga, Málaga, Spain; Instituto de Investigación Biomédica de Málaga (IBIMA), Spain. Electronic address: fransancheztorralvo@gmail.com.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Vázquez Pedreño', 'Affiliation': 'UGC Aparato Digestivo, Unidad de Endoscopias. Hospital Regional Universitario de Málaga, Málaga, Spain.'}, {'ForeName': 'Montserrat', 'Initials': 'M', 'LastName': 'Gonzalo Marín', 'Affiliation': 'UGC Endocrinología y Nutrición, Hospital Regional Universitario de Málaga, Plaza del Hospital Civil, S/N, 29009, Málaga, Spain; Centro de Investigación Biomédica en Red de Diabetes y Enfermedades Metabólicas Asociadas (CIBERDEM), Instituto de Salud Carlos III, Madrid, Spain; Instituto de Investigación Biomédica de Málaga (IBIMA), Spain.'}, {'ForeName': 'María José', 'Initials': 'MJ', 'LastName': 'Tapia', 'Affiliation': 'UGC Endocrinología y Nutrición, Hospital Regional Universitario de Málaga, Plaza del Hospital Civil, S/N, 29009, Málaga, Spain; Centro de Investigación Biomédica en Red de Diabetes y Enfermedades Metabólicas Asociadas (CIBERDEM), Instituto de Salud Carlos III, Madrid, Spain; Instituto de Investigación Biomédica de Málaga (IBIMA), Spain.'}, {'ForeName': 'Fuensanta', 'Initials': 'F', 'LastName': 'Lima', 'Affiliation': 'UGC Endocrinología y Nutrición, Hospital Regional Universitario de Málaga, Plaza del Hospital Civil, S/N, 29009, Málaga, Spain.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'García Fuentes', 'Affiliation': 'Centro de Investigación Biomédica en Red de Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III, Madrid, Spain; Instituto de Investigación Biomédica de Málaga (IBIMA), Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'García', 'Affiliation': 'UGC Aparato Digestivo, Unidad de Endoscopias. Hospital Regional Universitario de Málaga, Málaga, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Moreno Ruiz', 'Affiliation': 'UGC Cirugía General y Digestiva, Hospital Regional Universitario de Málaga, Málaga, Spain.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Rodríguez Cañete', 'Affiliation': 'UGC Cirugía General y Digestiva, Hospital Regional Universitario de Málaga, Málaga, Spain.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Valdés', 'Affiliation': 'UGC Endocrinología y Nutrición, Hospital Regional Universitario de Málaga, Plaza del Hospital Civil, S/N, 29009, Málaga, Spain; Universidad de Málaga, Málaga, Spain; Centro de Investigación Biomédica en Red de Diabetes y Enfermedades Metabólicas Asociadas (CIBERDEM), Instituto de Salud Carlos III, Madrid, Spain; Instituto de Investigación Biomédica de Málaga (IBIMA), Spain.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Olveira', 'Affiliation': 'UGC Endocrinología y Nutrición, Hospital Regional Universitario de Málaga, Plaza del Hospital Civil, S/N, 29009, Málaga, Spain; Universidad de Málaga, Málaga, Spain; Centro de Investigación Biomédica en Red de Diabetes y Enfermedades Metabólicas Asociadas (CIBERDEM), Instituto de Salud Carlos III, Madrid, Spain; Instituto de Investigación Biomédica de Málaga (IBIMA), Spain.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2020.10.008']
2145,33092947,Transnasal Flexible Laryngoscopy Using Different Topical Preparations and Methods of Application-A Randomized Study.,"BACKGROUND


The field of laryngology has grown exponentially since the advent of the transnasal flexible laryngoscopy. Flexible laryngoscopy when performed skillfully using the proper technique, facilitates a good view of the hidden areas of the larynx.
OBJECTIVE


To compare the effectiveness of the topical agents in providing a more comfortable experience for the patient, allowing the practitioner to advance the endoscope with less friction, pain and discomfort for the patient using 10% lidocaine spray, 2% lidocaine gel, 4% lidocaine with xylometazoline (1:1) soaked pledgets, or aqueous gel.
MATERIALS AND METHODS


A prospective randomized single-blinded clinical trial was conducted in a tertiary care teaching hospital in South India where 376 patients were recruited and allocated into four groups based on the topical preparation used. Following endoscopy, each subject filled a questionnaire grading their experience on a visual analogue scale. The clinician also then answered a questionnaire on aspects of the endoscopy performed.
RESULTS


The pain score and the ease of performing the procedure among the different groups were comparable. Those in the 10% lidocaine arm experienced significant burning sensation (P = 0.0001). The other variables such as throat pain (P = 0.783), gag reflex (P = 0.318), unpleasant taste (P = 0.092), globus (P = 0.190), swallowing difficulty after the procedure (P = 0.273), difficulty in breathing (P = 0.744) and willingness to have a repeat procedure (P = 0.883) were also comparable.
CONCLUSION


Aqueous gel can be used topically during a flexible nasopharyngolaryngoscopy instead of an anesthetic agent alone or one combined with a nasal decongestant.",2020,"The other variables such as throat pain (P = 0.783), gag reflex (P = 0.318), unpleasant taste (P = 0.092), globus (P = 0.190), swallowing difficulty after the procedure (P = 0.273), difficulty in breathing (P = 0.744) and willingness to have a repeat procedure (P = 0.883) were also comparable.
",['tertiary care teaching hospital in South India where 376 patients'],"['Transnasal Flexible Laryngoscopy', 'lidocaine spray, 2% lidocaine gel, 4% lidocaine with xylometazoline (1:1) soaked pledgets, or aqueous gel', 'lidocaine', 'Flexible laryngoscopy']","['gag reflex', 'throat pain', 'burning sensation', 'difficulty in breathing', 'unpleasant taste', 'pain score', 'swallowing difficulty']","[{'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0521131', 'cui_str': 'Transnasal approach'}, {'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C0023072', 'cui_str': 'Laryngoscopy'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C1154182', 'cui_str': 'Spray dose form'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0078643', 'cui_str': 'xylometazoline'}, {'cui': 'C0204774', 'cui_str': 'Soak'}, {'cui': 'C4521311', 'cui_str': 'Pledget'}]","[{'cui': 'C0016927', 'cui_str': 'Gagging'}, {'cui': 'C0242429', 'cui_str': 'Pain in throat'}, {'cui': 'C0085624', 'cui_str': 'Burning sensation'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0039336', 'cui_str': 'Finding of sense of taste'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}]",376.0,0.0357315,"The other variables such as throat pain (P = 0.783), gag reflex (P = 0.318), unpleasant taste (P = 0.092), globus (P = 0.190), swallowing difficulty after the procedure (P = 0.273), difficulty in breathing (P = 0.744) and willingness to have a repeat procedure (P = 0.883) were also comparable.
","[{'ForeName': 'Asha K', 'Initials': 'AK', 'LastName': 'Joy', 'Affiliation': 'Department of ENT, Christian Medical College, Vellore, Tamil Nadu, India; Christian Fellowship Hospital, Oddanchatram, Tamil Nadu, India.'}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Philip', 'Affiliation': 'Department of ENT, Christian Medical College, Vellore, Tamil Nadu, India.'}, {'ForeName': 'Suma Susan', 'Initials': 'SS', 'LastName': 'Mathews', 'Affiliation': 'Department of ENT, Christian Medical College, Vellore, Tamil Nadu, India. Electronic address: sumasusanm@yahoo.co.in.'}, {'ForeName': 'Rita Ruby A', 'Initials': 'RRA', 'LastName': 'Albert', 'Affiliation': 'Department of ENT, Christian Medical College, Vellore, Tamil Nadu, India.'}]",Journal of voice : official journal of the Voice Foundation,['10.1016/j.jvoice.2020.10.009']
2146,33092957,The use of intraoperative bedside lung ultrasound in optimizing positive end expiratory pressure in obese patients undergoing laparoscopic bariatric surgeries.,"BACKGROUND


Anesthetic management of patients with obesity undergoing laparoscopic abdominal surgeries requires careful plan for intraoperative mechanical ventilation aiming to avoid lung atelectasis and/or overdistention. There are conflicting data on the optimum positive end expiratory pressure (PEEP) during these surgeries. We hypothesized that lung ultrasound could be used for PEEP titration during laparoscopic surgery.
OBJECTIVE


The purpose of this study is to evaluate the effectiveness of intraoperative individualized lung ultrasound-guided PEEP in obese patients undergoing laparoscopic bariatric surgery on intraoperative partial arterial oxygen tension (PaO 2 ) and early postoperative pulmonary complications.
METHODS


A randomized controlled trial included 40 adult patients with body mass index (BMI) > 35 kg/m 2  undergoing laparoscopic bariatric surgery. Patients were randomized into: control group (n = 20) who received PEEP 4 cm.H 2  O and ultrasound-guided group (n = 20) who received individualized lung ultrasound stepwise PEEP. All patients received volume-controlled ventilation with a tidal volume of 6 mL/kg of ideal weight and a fraction of inspired oxygen of .5. The primary outcome was the difference in partial arterial oxygen tension (PaO 2 ) between the control group and the ultrasound-guided group. The secondary outcomes included the incidence of early postoperative pulmonary atelectasis, respiratory failure, bronchospasm, hypoxia or pneumothorax.
SETTINGS


General surgery operating theatre at Cairo University hospitals.
RESULTS


Ultrasound-guided group showed higher PO 2  after PEEP optimization and postoperatively compared with control group (P = .005, and P = .01 respectively). Also, ultrasound-guided group showed no postoperative complications compared with control group that had 5 cases who developed postoperative pulmonary complications in the form of hypoxia and basal collapse in the first 24 hour postoperatively chest x ray (0% versus 25%, P = .047).
CONCLUSION


In patients with obesity undergoing laparoscopic bariatric surgery, the use of lung ultrasound individualized stepwise PEEP approach improved oxygenation, compliance and reduced the incidence of postoperative pulmonary atelectasis and hypoxia without causing hemodynamic instability.",2020,"RESULTS


Ultrasound-guided group showed higher PO 2  after PEEP optimization and postoperatively compared with control group (P = .005, and P = .01 respectively).","['obese patients undergoing', 'patients with obesity undergoing laparoscopic abdominal surgeries', 'General surgery operating theatre at Cairo University hospitals', 'patients with obesity undergoing laparoscopic bariatric surgery', 'obese patients undergoing laparoscopic bariatric surgeries', '40 adult patients with body mass index (BMI) > 35 kg/m 2  undergoing laparoscopic bariatric surgery']","['intraoperative bedside lung ultrasound', 'individualized lung ultrasound stepwise PEEP', 'volume-controlled ventilation with a tidal volume of 6 mL/kg of ideal weight and a fraction of inspired oxygen of .5', 'intraoperative individualized lung ultrasound-guided PEEP', 'PEEP 4 cm', 'laparoscopic bariatric surgery']","['partial arterial oxygen tension (PaO 2 ', 'postoperative complications', 'hypoxia and basal collapse', 'incidence of early postoperative pulmonary atelectasis, respiratory failure, bronchospasm, hypoxia or pneumothorax', 'intraoperative partial arterial oxygen tension', 'postoperative pulmonary complications', 'optimum positive end expiratory pressure (PEEP']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}, {'cui': 'C1274039', 'cui_str': 'General surgery'}, {'cui': 'C0029064', 'cui_str': 'Operating theatre'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C4286019', 'cui_str': 'Lung ultrasound'}, {'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C1320708', 'cui_str': 'Volume controlled ventilation'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C1300574', 'cui_str': 'mL/kg'}, {'cui': 'C0421272', 'cui_str': 'Ideal body weight'}, {'cui': 'C0428167', 'cui_str': 'Fraction of inspired oxygen'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}]","[{'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0202155', 'cui_str': 'Oxygen measurement, partial pressure, arterial'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C2350824', 'cui_str': 'Postoperative Pulmonary Atelectasis'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C0006266', 'cui_str': 'Bronchospasm'}, {'cui': 'C0032326', 'cui_str': 'Pneumothorax'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}]",40.0,0.245096,"RESULTS


Ultrasound-guided group showed higher PO 2  after PEEP optimization and postoperatively compared with control group (P = .005, and P = .01 respectively).","[{'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Elshazly', 'Affiliation': 'Department of Anesthesia, Surgical ICU, and Pain Management, Cairo University, Cairo, Egypt. Electronic address: dr.mohamed.elshazly8686@gmail.com.'}, {'ForeName': 'Tamer', 'Initials': 'T', 'LastName': 'Khair', 'Affiliation': 'Department of Anesthesia, Surgical ICU, and Pain Management, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Bassem', 'Affiliation': 'Department of Anesthesia, Surgical ICU, and Pain Management, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Mansour', 'Affiliation': 'Department of Anesthesia, Surgical ICU, and Pain Management, Cairo University, Cairo, Egypt.'}]",Surgery for obesity and related diseases : official journal of the American Society for Bariatric Surgery,['10.1016/j.soard.2020.09.023']
2147,33092978,Calcium daily intake and the efficacy of a training intervention on optimizing calcium supplementation therapy: A clinical audit.,"BACKGROUND AND AIMS


Calcium is an essential element for human health, with key roles in the prevention and therapy of multifactorial conditions. Calcium dietary intake is often insufficient in the general population. The aim of this study was to perform a clinical audit for general practitioners (GPs) to understand the efficacy of training intervention on doctors' awareness about dietary calcium and supplements.
METHODS AND RESULTS


General practice outpatients were enrolled (Before Clinical Audit, BCA) from the same sanitary district, and calcium dietary intake was evaluated with a validated questionnaire, also collecting information about the consumption of calcium and vitamin D supplements. Then, a training intervention with a frontal lesson and discussion with GPs involved was performed. After one month of this intervention, a second outpatient enrolment was performed (Post Clinical Audit, PCA) in the same general practices to evaluate differences in nutritional suggestions and supplement prescription by GPs. In BCA, the calcium dietary intake was low, with nobody reaching 1000 mg as suggested by the guidelines. Only 6.6% and 24.5% took calcium and vitamin D supplements, respectively; in the PCA, these percentages increased to 28% and 78% for calcium and vitamin D supplements, respectively (p < 0.01 PCA vs BCA). There were no differences in calcium dietary intake between BCA and PCA.
CONCLUSION


Training intervention on GPs was successful to sensitize them regarding calcium intake problems; GPs tended to increase the prescription of supplements but not to suggest changes in dietary habits.",2020,"There were no differences in calcium dietary intake between BCA and PCA.
CONCLUSION


Training intervention on GPs was successful to sensitize them regarding calcium intake problems; GPs tended to increase the prescription of supplements but not to suggest changes in dietary habits.","['General practice outpatients were enrolled (Before Clinical Audit, BCA) from the same sanitary district, and calcium dietary intake', 'general practitioners (GPs']","['training intervention', 'calcium and vitamin D supplements']",['calcium dietary intake'],"[{'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C1956094', 'cui_str': 'Clinical Audit'}, {'cui': 'C0006726', 'cui_str': 'Dietary Calcium'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0017319', 'cui_str': 'General physician'}]","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0420176', 'cui_str': 'Vitamin D supplement therapy'}]","[{'cui': 'C0006726', 'cui_str': 'Dietary Calcium'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]",,0.0212199,"There were no differences in calcium dietary intake between BCA and PCA.
CONCLUSION


Training intervention on GPs was successful to sensitize them regarding calcium intake problems; GPs tended to increase the prescription of supplements but not to suggest changes in dietary habits.","[{'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Muscariello', 'Affiliation': 'Endocrinology and Nutrition Department, Ospedale del Mare, Naples, Italy. Electronic address: drmuscariello@gmail.com.'}, {'ForeName': 'Domenico', 'Initials': 'D', 'LastName': 'Rendina', 'Affiliation': 'Department of Clinical Medicine and Surgery, ""Federico II"" University, Naples, Italy.'}, {'ForeName': 'Raffaele', 'Initials': 'R', 'LastName': 'Giannettino', 'Affiliation': 'Endocrinology and Nutrition Department, Ospedale del Mare, Naples, Italy.'}, {'ForeName': 'Serena', 'Initials': 'S', 'LastName': 'Ippolito', 'Affiliation': 'Endocrinology and Nutrition Department, Ospedale del Mare, Naples, Italy.'}, {'ForeName': 'Ornella', 'Initials': 'O', 'LastName': 'Romano', 'Affiliation': 'Endocrinology and Nutrition Department, Ospedale del Mare, Naples, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Coretti', 'Affiliation': 'Endocrinology and Nutrition Department, Ospedale del Mare, Naples, Italy.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'De Vita', 'Affiliation': 'Endocrinology and Nutrition Department, Ospedale del Mare, Naples, Italy.'}, {'ForeName': 'Mariarosaria', 'Initials': 'M', 'LastName': 'Martino', 'Affiliation': 'Endocrinology and Nutrition Department, Ospedale del Mare, Naples, Italy.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Sepe', 'Affiliation': 'Endocrinology and Nutrition Department, Ospedale del Mare, Naples, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Nuzzo', 'Affiliation': 'Endocrinology and Nutrition Department, Ospedale del Mare, Naples, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Nutrition, metabolism, and cardiovascular diseases : NMCD",['10.1016/j.numecd.2020.08.005']
2148,33093338,Preliminary Evidence for the Fibromyalgia Integrative Training Program (FIT Teens) Improving Strength and Movement Biomechanics in Juvenile Fibromyalgia: Secondary Analysis and Results from a Pilot Randomized Clinical Trial.,"OBJECTIVES


Current therapies for Juvenile Fibromyalgia (JFM), such as cognitive-behavioral therapy (CBT), improve pain coping but are less effective for pain reduction or engagement in physical activity. The Fibromyalgia Integrative Training for Teens (FIT Teens) program combines CBT with specialized neuromuscular exercise training for adolescents with JFM. The current investigation examined the effects of FIT Teens vs CBT on secondary outcomes of strength and functional biomechanics, utilizing 3D Motion capture technology. This study aimed to explore improvements in strength and biomechanics in both a CBT-only group and the FIT Teens intervention.
METHODS


Forty adolescents with JFM (12-18▒y) were randomized to an 8-week, group-based protocol of either FIT Teens or CBT only. Assessments occurred pre- and post- treatment. Hip and knee strength were assessed with dynamometry, dynamic postural stability was measured using the Star Excursion Balance Test, and movement biomechanics were assessed with 3D motion analyses during a Drop Vertical Jump (DVJ) task.
RESULTS


The FIT Teens group exhibited improvements in hip abduction strength and greater external hip rotation during the DVJ task. Some differences between the FIT Teens and CBT groups were observed in peak hip internal moment in the transverse plane. Decreased hip adduction during the DVJ was also observed in the FIT Teens group.
DISCUSSION


Results suggest that the FIT Teens program shows promise in improving hip abduction strength and body biomechanics, indicating improvements in stability during functional movements. These improvements may facilitate ability to initiate and maintain regular physical activity in youth with widespread musculoskeletal pain.",2020,The FIT Teens group exhibited improvements in hip abduction strength and greater external hip rotation during the DVJ task.,"['Juvenile Fibromyalgia', 'adolescents with JFM', 'Fibromyalgia Integrative Training Program (FIT Teens', 'youth with widespread musculoskeletal pain', 'Forty adolescents with JFM (12-18▒', 'Juvenile Fibromyalgia (JFM']","['specialized neuromuscular exercise training', 'FIT Teens vs CBT']","['hip abduction strength and body biomechanics', 'strength and biomechanics', 'hip abduction strength and greater external hip rotation', 'peak hip internal moment', 'dynamometry, dynamic postural stability', 'Hip and knee strength', 'Star Excursion Balance Test, and movement biomechanics', 'Improving Strength and Movement Biomechanics', 'Decreased hip adduction']","[{'cui': 'C3146221', 'cui_str': 'Juvenile'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0205219', 'cui_str': 'Diffuse'}, {'cui': 'C0026858', 'cui_str': 'Musculoskeletal pain'}]","[{'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0086505', 'cui_str': 'Kidnapping'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0282064', 'cui_str': 'Stars, Celestial'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0231457', 'cui_str': 'Adduction'}]",40.0,0.0300868,The FIT Teens group exhibited improvements in hip abduction strength and greater external hip rotation during the DVJ task.,"[{'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Black', 'Affiliation': 'University of Kansas Medical Center.'}, {'ForeName': 'Christopher A', 'Initials': 'CA', 'LastName': 'DiCesare', 'Affiliation': ""Cincinnati Children's Hospital, Division of Sports Medicine.""}, {'ForeName': 'Staci', 'Initials': 'S', 'LastName': 'Thomas', 'Affiliation': ""Cincinnati Children's Hospital, Division of Sports Medicine.""}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Pfeiffer', 'Affiliation': ""Cincinnati Children's Hospital, Division of Behavioral Medicine and Clinical Psychology.""}, {'ForeName': 'Sara E', 'Initials': 'SE', 'LastName': 'Williams', 'Affiliation': ""Cincinnati Children's Hospital, Division of Behavioral Medicine and Clinical Psychology.""}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Kitchen', 'Affiliation': ""Cincinnati Children's Hospital, Division of Sports Medicine.""}, {'ForeName': 'Tracy V', 'Initials': 'TV', 'LastName': 'Ting', 'Affiliation': ""Cincinnati Children's Hospital, Division of Rheumatology.""}, {'ForeName': 'Gregory D', 'Initials': 'GD', 'LastName': 'Myer', 'Affiliation': ""Cincinnati Children's Hospital, Division of Sports Medicine.""}, {'ForeName': 'Susmita', 'Initials': 'S', 'LastName': 'Kashikar-Zuck', 'Affiliation': ""Cincinnati Children's Hospital, Division of Behavioral Medicine and Clinical Psychology.""}]",The Clinical journal of pain,['10.1097/AJP.0000000000000888']
2149,33093340,Investigating the Effects of Cuing Medication Availability on Patient-controlled Analgesia Pump Usage in Pediatric Patients: Results of a Randomized Controlled Trial.,"OBJECTIVES


The study of Patient-Controlled Analgesia (PCA) behaviors has led to greater understanding of factors that affect the pain experience. Although PCA behaviors can be influenced by cues to medication availability, no studies have examined the effects of such cues in pediatric populations.
METHODS


This randomized controlled trial examined patient satisfaction with pain management, PCA behaviors, opioid consumption and state-anxiety in a sample of 125 post-surgical children and adolescents (7-17▒y). Patients were randomized to a ""light"" group (lockout period status cued by light on PCA button) or control group (no cues to medication availability).
RESULTS


Although cuing did not affect patient satisfaction with pain management (P=0.11), patients in the light group consumed significantly more opioid than those in the control group (adj. P=0.016). This effect was primarily due to children in the light group (Median 0.019, Interquartile Range 0.012-0.036▒mg/kg/h) consuming more opioid than children (≤12▒y) in control group (Median 0.015, Interquartile Range 0.006-0.025▒mg/kg/h) (P=0.007). In contrast to the control group, for patients in the light group opioid consumption was unrelated to pain and the proportion of patients with a 1:1 injections:attempts ratio was higher (P<0.001) across the study period.
DISCUSSION


The overall pattern of results suggests that patients in the light group used their PCA in response to the light, more than in response to their pain, which likely reflects operant influences on PCA behavior by pediatric patients.",2020,"Although cuing did not affect patient satisfaction with pain management (P=0.11), patients in the light group consumed significantly more opioid than those in the control group (adj.","['patient satisfaction with pain management, PCA behaviors, opioid consumption and state-anxiety in a sample of 125 post-surgical children and adolescents (7-17▒', 'Pediatric Patients']","['light"" group (lockout period status cued by light on PCA button) or control group (no cues to medication availability', 'Cuing Medication Availability']",['patient satisfaction with pain management'],"[{'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C0453985', 'cui_str': 'Button'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}]","[{'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]",,0.0589623,"Although cuing did not affect patient satisfaction with pain management (P=0.11), patients in the light group consumed significantly more opioid than those in the control group (adj.","[{'ForeName': 'Keri R', 'Initials': 'KR', 'LastName': 'Hainsworth', 'Affiliation': 'Department of Anesthesiology, Medical College of Wisconsin, Milwaukee, WI, USA.'}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Czarnecki', 'Affiliation': ""Jane B. Pettit Pain and Headache Center, Children's Wisconsin, Milwaukee, WI, USA.""}, {'ForeName': 'Pippa M', 'Initials': 'PM', 'LastName': 'Simpson', 'Affiliation': 'Quantitative Health Sciences, Medical College of Wisconsin, Milwaukee, WI, USA.'}, {'ForeName': 'Liyun', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Quantitative Health Sciences, Medical College of Wisconsin, Milwaukee, WI, USA.'}, {'ForeName': 'W Hobart', 'Initials': 'WH', 'LastName': 'Davies', 'Affiliation': 'Department of Psychology, University of Wisconsin-Milwaukee, Milwaukee WI, USA.'}, {'ForeName': 'Devin', 'Initials': 'D', 'LastName': 'Mueller', 'Affiliation': 'Department of Biological Sciences, Kent State University, Kent, OH, USA.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Weisman', 'Affiliation': 'Department of Anesthesiology, Medical College of Wisconsin, Milwaukee, WI, USA.'}]",The Clinical journal of pain,['10.1097/AJP.0000000000000892']
2150,33093415,Candy Cane Compared With Boot Stirrups in Vaginal Surgery: A Randomized Controlled Trial.,,2020,,['Vaginal Surgery'],['Candy Cane'],[],"[{'cui': 'C0195117', 'cui_str': 'Operation on vagina'}]","[{'cui': 'C0006855', 'cui_str': 'Candy'}, {'cui': 'C0006856', 'cui_str': 'Cane'}]",[],,0.233701,,"[{'ForeName': 'Miguel A', 'Initials': 'MA', 'LastName': 'Luna Russo', 'Affiliation': ""Section of Medical Gynecology and Minimally Invasive Gynecologic Surgery, Women's Health Institute, Cleveland, Ohio.""}, {'ForeName': 'Rosanne M', 'Initials': 'RM', 'LastName': 'Kho', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000004152']
2151,33093457,Irreversible electroporation plus allogenic Vγ9Vδ2 T cells enhances antitumor effect for locally advanced pancreatic cancer patients.,"Immunotherapy has limited efficacy against locally advanced pancreatic cancer (LAPC) due to the presence of an immunosuppressive microenvironment (ISM). Irreversible electroporation (IRE) can not only induce immunogenic cell death, but also alleviate immunosuppression. This study aimed to investigate the antitumor efficacy of IRE plus allogeneic γδ T cells in LAPC patients. A total of 62 patients who met the eligibility criteria were enrolled in this trial, then randomized into two groups (A: n = 30 and B: n = 32). All patients received IRE therapy and after receiving IRE, the group A patients received at least two cycles of γδ T-cell infusion as one course continuously. Group A patients had better survival than group B patients (median OS: 14.5 months vs. 11 months; median PFS: 11 months vs. 8.5 months). Moreover, the group A patients treated with multiple courses of γδ T-cell infusion had longer OS (17 months) than those who received a single course (13.5 months). IRE combined with allogeneic γδ T-cell infusion is a promising strategy to enhance the antitumor efficacy in LAPC patients, yielding extended survival benefits.ClinicalTrials.gov ID: NCT03180437.",2020,Group A patients had better survival than group B patients (median OS: 14.5 months vs. 11 months; median PFS: 11 months vs. 8.5 months).,"['62 patients who met the eligibility criteria', 'LAPC patients', 'locally advanced pancreatic cancer patients']","['Irreversible electroporation plus allogenic Vγ9Vδ2 T cells', 'IRE therapy and after receiving IRE', 'IRE combined with allogeneic γδ T-cell infusion', 'Irreversible electroporation (IRE', 'IRE plus allogeneic γδ T cells', 'Immunotherapy']","['antitumor efficacy', 'better survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0235974', 'cui_str': 'Carcinoma of pancreas'}]","[{'cui': 'C4319935', 'cui_str': 'Irreversible electroporation'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",62.0,0.0478856,Group A patients had better survival than group B patients (median OS: 14.5 months vs. 11 months; median PFS: 11 months vs. 8.5 months).,"[{'ForeName': 'Mao', 'Initials': 'M', 'LastName': 'Lin', 'Affiliation': 'Guangdong Provincial Key Laboratory of Proteomics, State Key Laboratory of Organ Failure Research, School of Basic Medical Sciences, Southern Medical University, Guangzhou, 510515, China.'}, {'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Guangdong Provincial Key Laboratory of Proteomics, State Key Laboratory of Organ Failure Research, School of Basic Medical Sciences, Southern Medical University, Guangzhou, 510515, China.'}, {'ForeName': 'Shuzhen', 'Initials': 'S', 'LastName': 'Liang', 'Affiliation': 'Medical Research Centre, The Third Affiliated Hospital, Sun Yat-sen University, Guangzhou, 510630, China.'}, {'ForeName': 'Haihua', 'Initials': 'H', 'LastName': 'Luo', 'Affiliation': 'Guangdong Provincial Key Laboratory of Proteomics, State Key Laboratory of Organ Failure Research, School of Basic Medical Sciences, Southern Medical University, Guangzhou, 510515, China.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Alnaggar', 'Affiliation': 'Department of Oncology, Tongji Chibi Hospital, Tongji Medical College, Huazhong University of Science and Technology, Chibi, 437300, China.'}, {'ForeName': 'Aihua', 'Initials': 'A', 'LastName': 'Liu', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Nanfang Hospital, Southern Medical University, Guangzhou, 510515, China.'}, {'ForeName': 'Zhinan', 'Initials': 'Z', 'LastName': 'Yin', 'Affiliation': 'The Biomedical Translational Research Institute, Faculty of Medical Science, Jinan University, Guangzhou, 510632, China.'}, {'ForeName': 'Jibing', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Biological Treatment Center, Fuda Cancer Hospital, Jinan University, Guangzhou, 510665, China. jibingchen398@163.com.'}, {'ForeName': 'Lizhi', 'Initials': 'L', 'LastName': 'Niu', 'Affiliation': 'Biological Treatment Center, Fuda Cancer Hospital, Jinan University, Guangzhou, 510665, China. 18922210657@163.com.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Guangdong Provincial Key Laboratory of Proteomics, State Key Laboratory of Organ Failure Research, School of Basic Medical Sciences, Southern Medical University, Guangzhou, 510515, China. jiang48231@163.com.'}]",Signal transduction and targeted therapy,['10.1038/s41392-020-00260-1']
2152,33093598,Population pharmacokinetics of levodopa gel infusion in Parkinson's disease: effects of entacapone infusion and genetic polymorphism.,"Levodopa-entacapone-carbidopa intestinal gel (LECIG) provides continuous drug delivery through intrajejunal infusion. The aim of this study was to characterize the population pharmacokinetics of levodopa following LECIG and levodopa-carbidopa intestinal gel (LCIG) infusion to investigate suitable translation of dose from LCIG to LECIG treatment, and the impact of common variations in the dopa-decarboxylase (DDC) and catechol-O-methyltransferase (COMT) genes on levodopa pharmacokinetics. A non-linear mixed-effects model of levodopa pharmacokinetics was developed using plasma concentration data from a double-blind, cross-over study of LCIG compared with LECIG in patients with advanced Parkinson's disease (n = 11). All patients were genotyped for rs4680 (polymorphism of the COMT gene), rs921451 and rs3837091 (polymorphisms of the DDC gene). The final model was a one compartment model with a high fixed absorption rate constant, and a first order elimination, with estimated apparent clearances (CL/F), of 27.9 L/h/70 kg for LCIG versus 17.5 L/h/70 kg for LECIG, and apparent volume of distribution of 74.4 L/70 kg. Our results thus suggest that the continuous maintenance dose of LECIG, on a population level, should be decreased by approximately 35%, to achieve similar drug exposure as with LCIG. An effect from entacapone was identified on all individuals, regardless of COMT rs4680 genotype. The individuals with higher DDC and COMT enzyme activity showed tendencies towards higher levodopa CL/F. The simultaneous administration of entacapone to LCIG administration results in a 36.5% lower apparent levodopa clearance, and there is a need for lower continuous maintenance doses, regardless of patients' COMT genotype.",2020,"The individuals with higher DDC and COMT enzyme activity showed tendencies towards higher levodopa CL/F. The simultaneous administration of entacapone to LCIG administration results in a 36.5% lower apparent levodopa clearance, and there is a need for lower continuous maintenance doses, regardless of patients' COMT genotype.","[""Parkinson's disease"", ""patients with advanced Parkinson's disease (n\u2009=\u200911""]","['levodopa following LECIG and levodopa-carbidopa intestinal gel (LCIG', 'entacapone', 'Levodopa-entacapone-carbidopa intestinal gel (LECIG', 'levodopa gel infusion', 'LECIG', 'levodopa pharmacokinetics']",['levodopa clearance'],"[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}]","[{'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0165921', 'cui_str': 'entacapone'}, {'cui': 'C0006982', 'cui_str': 'Carbidopa'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0353697', 'cui_str': 'Carbidopa- and levodopa-containing product'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}]","[{'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}]",,0.0927242,"The individuals with higher DDC and COMT enzyme activity showed tendencies towards higher levodopa CL/F. The simultaneous administration of entacapone to LCIG administration results in a 36.5% lower apparent levodopa clearance, and there is a need for lower continuous maintenance doses, regardless of patients' COMT genotype.","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Senek', 'Affiliation': 'Department of Neuroscience, Neurology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Nyholm', 'Affiliation': 'Department of Neuroscience, Neurology, Uppsala University, Uppsala, Sweden. dag.nyholm@neuro.uu.se.'}, {'ForeName': 'E I', 'Initials': 'EI', 'LastName': 'Nielsen', 'Affiliation': 'Department of Pharmacy, Uppsala University, Uppsala, Sweden.'}]",Scientific reports,['10.1038/s41598-020-75052-2']
2153,33096271,Pain sensitivity and autonomic nervous system parameters as predictors of dry eye symptoms after LASIK.,"PURPOSE


Differences in pain processing and autonomic function among patients have been implicated the development of chronic pain after surgery. This study was designed to evaluate whether pain and autonomic metrics predict severity of chronic dry eye (DE) symptoms after LASIK, as there is increasing evidence that DE symptoms may be manifestations of persistent post-operative ocular pain.
METHODS


Secondary analysis of prospective randomized clinical trial. Patients were treated with either pregabalin or placebo. As no significant differences in DE symptoms were detected by treatment allocation at six months, all participants were grouped together for the present analyses. Subjects were evaluated pre-LASIK with regard to evoked pain sensitivity (utilizing quantitative sensory testing), autonomic metrics and DE and ocular pain symptoms (via validated questionnaires). Measures of DE and ocular pain were assessed post-LASIK, and the Dry Eye Questionnaire 5 (DEQ5) score 6-months after surgery was the primary outcome of interest.
RESULTS


43 individuals were randomized to pregabalin (n = 21) or placebo (n = 22). 42 completed the 6-month visit. Several baseline autonomic metrics correlated with 6-month post-operative DEQ5 scores, including lower systolic (r -0.37, p = 0.02) and diastolic blood pressure (r -0.32, p = 0.04). Ocular pain at 6 months was also negatively correlated with blood pressure (r -0.31, p = 0.047). The presence of painful aftersensations was a significant predictor of chronic DE symptoms at 6 months (mean DEQ5 scores: 8.0 ± 1.9 versus 5.0 ± 5.0, p = 0.009).
CONCLUSIONS


Heightened parasympathetic tone and prolonged pain sensitivity measured prior to surgery predicted greater DE symptom severity 6 months after LASIK.
TRIAL REGISTRATION


NCT02701764.",2020,"Heightened parasympathetic tone and prolonged pain sensitivity measured prior to surgery predicted greater DE symptom severity 6 months after LASIK.
","['43 individuals', 'dry eye symptoms after LASIK']","['pregabalin', 'placebo', 'pregabalin or placebo']","['DE and ocular pain', 'Ocular pain', 'blood pressure', 'Heightened parasympathetic tone and prolonged pain sensitivity', 'lower systolic', 'evoked pain sensitivity (utilizing quantitative sensory testing), autonomic metrics and DE and ocular pain symptoms (via validated questionnaires', 'DE symptoms', 'chronic DE symptoms', 'Dry Eye Questionnaire 5 (DEQ5) score 6-months', 'diastolic blood pressure']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0752094', 'cui_str': 'Laser assisted in situ keratomileusis'}]","[{'cui': 'C0657912', 'cui_str': 'pregabalin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}, {'cui': 'C0151827', 'cui_str': 'Pain in eye'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0442803', 'cui_str': 'Heightened'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0430838', 'cui_str': 'Quantitative sensory test'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}]",43.0,0.287792,"Heightened parasympathetic tone and prolonged pain sensitivity measured prior to surgery predicted greater DE symptom severity 6 months after LASIK.
","[{'ForeName': 'Alexandra E', 'Initials': 'AE', 'LastName': 'Levitt', 'Affiliation': 'Bascom Palmer Eye Institute, University of Miami, Miami, FL, USA.'}, {'ForeName': 'Anat', 'Initials': 'A', 'LastName': 'Galor', 'Affiliation': 'Bascom Palmer Eye Institute, University of Miami, Miami, FL, USA; Department of Ophthalmology, Miami Veterans Administration Medical Center, Miami, FL, USA. Electronic address: agalor@med.miami.edu.'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Small', 'Affiliation': 'Bascom Palmer Eye Institute, University of Miami, Miami, FL, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Feuer', 'Affiliation': 'Bascom Palmer Eye Institute, University of Miami, Miami, FL, USA.'}, {'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Felix', 'Affiliation': 'Department of Physical Medicine & Rehabilitation, University of Miami, Miami, FL, USA; Research Service, Miami Veterans Administration Medical Center, Miami, FL, USA.'}]",The ocular surface,['10.1016/j.jtos.2020.10.004']
2154,33096291,Augmenting exposure therapy with pre-extinction fear memory reactivation and deepened extinction: A randomized controlled trial.,"BACKGROUND


Pre-extinction fear memory reactivation (PE-FMR) and deepened extinction (DE) enhance long-term extinction of shock-conditioned fear, and may also enhance long-term extinction of naturally acquired fear. Preliminary data suggest that PE-FMR may additionally boost the speed of fear reduction during exposure therapy.
DESIGN


Randomized controlled trial, factorial design.
METHODS


Participants with elevated fears of either spiders or snakes were randomized to (1) exposure therapy alone (n = 41), (2) exposure therapy + PE-FMR (n = 42), (3) exposure therapy + DE (n = 41), or (4) exposure therapy + PE-FMR + DE (n = 42). Participants were assessed at baseline, post-treatment, and one-week follow-up on subjective and behavioral indices of phobia. Because treatment length was tailored to speed of fear reduction, survival analyses were used to examine the speed of fear reduction during treatment.
RESULTS


DE did not improve clinical outcomes at post-treatment or follow-up, whereas PE-FMR produced more rapid fear reduction and was able to achive equivalent outcomes even when the duration of exposure therapy (tailored to speed of fear reduction) was shortened by an average of 21%.
CONCLUSIONS


Data suggest that PE-FMR is a promising strategy for reducing the overall duration of exposure-based therapies.
CLINICAL TRIAL REGISTRATION


(clinicaltrials.gov)NCT02160470.",2020,"RESULTS


DE did not improve clinical outcomes at post-treatment or follow-up, whereas PE-FMR produced more rapid fear reduction and was able to achive equivalent outcomes even when the duration of exposure therapy (tailored to speed of fear reduction) was shortened by an average of 21%.
",['Participants with elevated fears of either spiders or snakes'],"['Augmenting exposure therapy with pre-extinction fear memory reactivation and deepened extinction', 'PE-FMR', 'exposure therapy alone (n\xa0=\xa041), (2) exposure therapy\xa0+\xa0PE-FMR (n\xa0=\xa042), (3) exposure therapy\xa0+\xa0DE (n\xa0=\xa041), or (4) exposure therapy\xa0+\xa0PE-FMR\xa0+\xa0DE']","['clinical outcomes', 'rapid fear reduction']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0037913', 'cui_str': 'Order Araneae'}, {'cui': 'C0037382', 'cui_str': 'Suborder Serpentes'}]","[{'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0015347', 'cui_str': 'Psychological Extinction'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",42.0,0.0830397,"RESULTS


DE did not improve clinical outcomes at post-treatment or follow-up, whereas PE-FMR produced more rapid fear reduction and was able to achive equivalent outcomes even when the duration of exposure therapy (tailored to speed of fear reduction) was shortened by an average of 21%.
","[{'ForeName': 'Cynthia L', 'Initials': 'CL', 'LastName': 'Lancaster', 'Affiliation': 'Department of Psychology, University of Texas. 108 E. Dean Keeton Stop A8000. Austin, TX, USA; Department of Psychology, University of Nevada, Reno. 1664 N. Virginia Street, Mail Stop 0298. Reno, NV, USA. Electronic address: cynthialancaster@unr.edu.'}, {'ForeName': 'Marie-H', 'Initials': 'MH', 'LastName': 'Monfils', 'Affiliation': 'Department of Psychology, University of Texas. 108 E. Dean Keeton Stop A8000. Austin, TX, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Telch', 'Affiliation': 'Department of Psychology, University of Texas. 108 E. Dean Keeton Stop A8000. Austin, TX, USA. Electronic address: telch@austin.utexas.edu.'}]",Behaviour research and therapy,['10.1016/j.brat.2020.103730']
2155,33096332,"The role of expressive suppression and cognitive reappraisal in cognitive behavioral therapy for social anxiety disorder: A study of self-report, subjective, and electrocortical measures.","BACKGROUND


Contemporary models of cognitive behavioral therapy (CBT) for social anxiety disorder (SAD) emphasize emotion dysregulation as a core impairment whose reduction may play a causal role in psychotherapy. The current study examined changes in use of emotion regulation strategies as possible mechanisms of change in CBT for SAD. Specifically, we examined changes in expressive suppression and cognitive reappraisal during CBT and whether these changes predict treatment outcome.
METHODS


Patients (n = 34; 13 females; Mean age = 28.36 (6.97)) were allocated to 16-20 sessions of CBT. An electrocortical measure of emotion regulation and a clinician-rated measure of SAD were administered monthly. Self-report measures of emotion regulation and social anxiety were administered weekly. Multilevel models were used to examine changes in emotion regulation during treatment and cross-lagged associations between emotion regulation and anxiety.
RESULTS


CBT led to decreased suppression frequency, increased reappraisal self-efficacy, and decreased unpleasantness for SAD-related pictures (ps < .05). At post-treatment, patients were equivalent to healthy controls in terms of suppression frequency and subjective reactivity to SAD-related stimuli. Gains were maintained at 3-months follow-up. Decreases in suppression frequency and electrocortical reactivity to SAD-related pictures predicted lower subsequent anxiety but not the other way around (ps < .05). Lower anxiety predicted greater subsequent increases in reappraisal self-efficacy.
LIMITATIONS


The lack of a control group precludes conclusions regarding mechanisms specificity.
CONCLUSIONS


Decreased frequency of suppression is a potential mechanism of change in CBT for SAD.",2020,"At post-treatment, patients were equivalent to healthy controls in terms of suppression frequency and subjective reactivity to SAD-related stimuli.","['Patients (n\xa0', 'social anxiety disorder', '34; 13 females; Mean age\xa0=\xa028.36 (6.97']","['cognitive behavioral therapy (CBT', 'expressive suppression and cognitive reappraisal in cognitive behavioral therapy']","['emotion regulation', 'emotion regulation and social anxiety', 'suppression frequency and electrocortical reactivity to SAD-related pictures predicted lower subsequent anxiety', 'suppression frequency, increased reappraisal self-efficacy, and decreased unpleasantness for SAD-related pictures', 'expressive suppression and cognitive reappraisal', 'reappraisal self-efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031572', 'cui_str': 'Social phobia'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}]","[{'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0031572', 'cui_str': 'Social phobia'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}]",,0.0112977,"At post-treatment, patients were equivalent to healthy controls in terms of suppression frequency and subjective reactivity to SAD-related stimuli.","[{'ForeName': 'Yogev', 'Initials': 'Y', 'LastName': 'Kivity', 'Affiliation': 'Department of Psychology, The Hebrew University of Jerusalem, Jerusalem, Israel. Electronic address: yogev.kivity@biu.ac.il.'}, {'ForeName': 'Lior', 'Initials': 'L', 'LastName': 'Cohen', 'Affiliation': 'Department of Psychology, The Hebrew University of Jerusalem, Jerusalem, Israel.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Weiss', 'Affiliation': 'Department of Psychology, The Hebrew University of Jerusalem, Jerusalem, Israel.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Elizur', 'Affiliation': 'Department of Psychology, The Hebrew University of Jerusalem, Jerusalem, Israel.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Huppert', 'Affiliation': 'Department of Psychology, The Hebrew University of Jerusalem, Jerusalem, Israel.'}]",Journal of affective disorders,['10.1016/j.jad.2020.10.021']
2156,33096333,Effectiveness of guided internet-based interventions in the indicated prevention of depression in green professions (PROD-A): Results of a pragmatic randomized controlled trial.,"BACKGROUND


Major Depressive Disorder (MDD) has a major impact on public health. Reduction of depression burden in general population is of greatest importance and might be achieved by implementation of depression prevention measures into routine care. We evaluate an online prevention measure as part of a national project aiming to reduce depression in the occupational group of green professions.
METHODS


This two-armed pragmatic RCT (n = 360) evaluates the effectiveness of a tailored internet-based intervention (IMI) program compared to enhanced treatment as usual. The IMI program entailed access to one of six guided IMIs each focusing on different symptom areas (depressive mood with optional comorbid diabetes, perceived stress, insomnia, panic and agoraphobia and harmful alcohol consumption). Eligible were entrepreneurs, spouses, family members and pensioners in green professions with adequate insurance status and at least subthreshold depression (PHQ≥5). Primary outcome was depressive symptom severity (QIDS-SR16) at 9-weeks post-treatment (T1). Various secondary outcomes were assessed at T1.
RESULTS


A small effect of depression reduction (d=-0.28, 95%-CI: -0.50 to -0.07) was found at T1 favouring the IMI program (β=-0.22, 95%-CI: -0.41 to -0.02, p=.033). Categorical analysis indicated a reduced risk of potential MDD with NNTB=28.11. Adherence to the IMI program at T1 was exceptionally low.
LIMITATIONS


Results are limited to green professions and representativeness might be restricted by self-selection of participants.
CONCLUSION


Depression burden in green professions can be reduced by this online prevention measure. Yet, short-term effectiveness is restricted by low adherence rates.
TRIAL REGISTRATION


German Clinical Trial Registration: DRKS00014000. Registered: 09 April 2018.",2020,"A small effect of depression reduction (d=-0.28, 95%-CI: -0.50 to -0.07) was found at T1 favouring the IMI program (β=-0.22, 95%-CI: -0.41 to -0.02, p=.033).","['green professions (PROD-A', 'Eligible were entrepreneurs, spouses, family members and pensioners in green professions with adequate insurance status and at least subthreshold depression (PHQ≥5', 'Major Depressive Disorder (MDD']","['guided internet-based interventions', 'tailored internet-based intervention (IMI) program']","['stress, insomnia, panic and agoraphobia and harmful alcohol consumption', 'risk of potential MDD', 'depressive symptom severity (QIDS-SR16', 'depression reduction']","[{'cui': 'C0332583', 'cui_str': 'Green color'}, {'cui': 'C0028811', 'cui_str': 'Occupation'}, {'cui': 'C0070319', 'cui_str': 'Cytochrome p450 CYP2B1 enzyme'}, {'cui': 'C0162409', 'cui_str': 'Spouse'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0376629', 'cui_str': 'Insurance Status'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]","[{'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C3898714', 'cui_str': 'Internet Intervention'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0030318', 'cui_str': 'Panic'}, {'cui': 'C0001818', 'cui_str': 'Agoraphobia'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0585291', 'cui_str': 'Four times daily'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",,0.107642,"A small effect of depression reduction (d=-0.28, 95%-CI: -0.50 to -0.07) was found at T1 favouring the IMI program (β=-0.22, 95%-CI: -0.41 to -0.02, p=.033).","[{'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Braun', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Institute of Psychology and Education, University of Ulm, Ulm, Germany. Electronic address: lina.braun@uni-ulm.de.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Titzler', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Institute of Psychology, Friedrich-Alexander-University of Erlangen-Nürnberg, Erlangen, Germany; GET.ON Institute, Berlin, Germany.'}, {'ForeName': 'Yannik', 'Initials': 'Y', 'LastName': 'Terhorst', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Institute of Psychology and Education, University of Ulm, Ulm, Germany; Department of Research Methods, Institute of Psychology and Education, University of Ulm, Germany.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Freund', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Institute of Psychology, Friedrich-Alexander-University of Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Janika', 'Initials': 'J', 'LastName': 'Thielecke', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Institute of Psychology, Friedrich-Alexander-University of Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'David Daniel', 'Initials': 'DD', 'LastName': 'Ebert', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Institute of Psychology, Friedrich-Alexander-University of Erlangen-Nürnberg, Erlangen, Germany; GET.ON Institute, Berlin, Germany; Department of Clinical, Neuro- & Developmental Psychology, VU University Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Baumeister', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Institute of Psychology and Education, University of Ulm, Ulm, Germany.'}]",Journal of affective disorders,['10.1016/j.jad.2020.09.066']
2157,33096356,"Adjunct high-frequency transcranial random noise stimulation over the lateral prefrontal cortex improves negative symptoms of schizophrenia: A randomized, double-blind, sham-controlled pilot study.","High-frequency transcranial random noise stimulation (hf-tRNS) is a non-invasive neuromodulatory technique capable of increasing human cortex excitability. There were only published case reports on the use of hf-tRNS targeting the lateral prefrontal cortex in treating negative symptoms of schizophrenia, thus necessitating systematic investigation. We designed a randomized, double-blind, sham-controlled trial in a cohort of stabilized schizophrenia patients to examine the efficacy of add-on hf-tRNS (100-640 Hz; 2 mA; 20 min) using a high definition 4 × 1 electrode montage (anode AF3, cathodes AF4, F2, F6, and FC4) in treating negative symptoms (ClinicalTrials.gov ID: NCT04038788). Participants received either active hf-tRNS or sham twice daily for 5 consecutive weekdays. Primary outcome measure was the change over time in the Positive and Negative Syndrome Scale Factor Score for Negative Symptoms (PANSS-FSNS), which was measured at baseline, after 10-session stimulation, and at one-week and one-month follow-ups. Among 36 randomized patients, 35 (97.2%) completed the trial. Intention-to-treat analysis showed a significantly greater decrease in PANSS-FSNS score after active (-17.11%) than after sham stimulation (-1.68%), with a large effect size (Cohen's d = 2.16, p < 0.001). The beneficial effect lasted for up to one month. In secondary-outcome analyses, the authors observed improvements with hf-tRNS of disorganization symptoms, unawareness of negative symptoms, subjective response to taking antipsychotics, and antipsychotic-induced extrapyramidal symptoms. No effects were observed on the neurocognitive performance and other outcome measures. Overall, hf-tRNS was safe and efficacious in improving negative symptoms. Our promising findings should be confirmed in a larger sample of patients with predominant negative symptoms.",2020,No effects were observed on the neurocognitive performance and other outcome measures.,"['stabilized schizophrenia patients', '36 randomized patients, 35 (97.2%) completed the trial', 'schizophrenia']","['High-frequency transcranial random noise stimulation (hf-tRNS', 'Adjunct high-frequency transcranial random noise stimulation', 'active hf-tRNS']","['PANSS-FSNS score', 'disorganization symptoms, unawareness of negative symptoms, subjective response to taking antipsychotics, and antipsychotic-induced extrapyramidal symptoms', 'change over time in the Positive and Negative Syndrome Scale Factor Score for Negative Symptoms (PANSS-FSNS', 'neurocognitive performance']","[{'cui': 'C0184512', 'cui_str': 'Stabilized'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517910', 'cui_str': '97.2'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C3852967', 'cui_str': 'Transcranial Random Noise Stimulation'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0041657', 'cui_str': 'Loss of consciousness'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0234133', 'cui_str': 'Extrapyramidal sign'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",36.0,0.528973,No effects were observed on the neurocognitive performance and other outcome measures.,"[{'ForeName': 'Chuan-Chia', 'Initials': 'CC', 'LastName': 'Chang', 'Affiliation': 'Department of Psychiatry, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan.'}, {'ForeName': 'Yen-Yue', 'Initials': 'YY', 'LastName': 'Lin', 'Affiliation': 'Department of Emergency Medicine, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan; Department of Emergency Medicine, Taoyuan Armed Forces General Hospital, Taoyuan, Taiwan; Department of Life Sciences, National Central University, Taoyuan, Taiwan.'}, {'ForeName': 'Nian-Sheng', 'Initials': 'NS', 'LastName': 'Tzeng', 'Affiliation': 'Department of Psychiatry, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan.'}, {'ForeName': 'Yu-Chen', 'Initials': 'YC', 'LastName': 'Kao', 'Affiliation': 'Department of Psychiatry, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan; Department of Psychiatry, Tri-Service General Hospital Songshan Branch, National Defense Medical Center, Taipei, Taiwan.'}, {'ForeName': 'Hsin-An', 'Initials': 'HA', 'LastName': 'Chang', 'Affiliation': 'Department of Psychiatry, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan. Electronic address: chang.ha@mail.ndmctsgh.edu.tw.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.10.008']
2158,33096362,Simulation strategies to increase nursing student clinical competence in safe medication administration practices: A quasi-experimental study.,"BACKGROUND


Nursing student medication errors often result from deficits in knowledge and application of fundamental safe administration practices. Factors such as high faculty-student ratios and legal restrictions have decreased clinical learning opportunities for nursing students to practice safe medication administration in the clinical setting. Evidence suggests that use of a structured medication safety enhancement (MSE) simulation program can significantly improve student knowledge and competency in safe medication administration.
PURPOSE


To examine the effects of an educational strategy using a MSE simulation program with integrated technology on the medication administration knowledge, competency, and confidence levels of undergraduate nursing students.
METHODS


This quasi-experimental replication study designed and implemented medication simulations enhanced by integrated information technologies in an undergraduate-nursing curriculum. Third-year BSN students (n = 83) were randomized into intervention or control groups. Control groups participated in standard training while the intervention group received additional clinical simulation experience and debriefing sessions focused on medication safety practices. Participant knowledge was measured using pre/post Medication Safety Knowledge Assessment (MSKA) and competency was evaluated using the Medication Safety Critical Element Checklist (MSCEC).
RESULTS


The MSKA and MSCEC were analyzed using two-sided independent t-tests. Post-test knowledge scores increased in both groups but results were not statistically significant (α = 0. 05). Students who received the medication safetfy enhancement intervention performed significantly better in a subsequent simulation than students who did not have prior simulation experience (p < .001).
CONCLUSION


Findings suggest that educators should consider high fidelity simulation as an evidence-based teaching strategy to engage students in understanding and implementing medication safety practices in the clinical setting.",2020,"Students who received the medication safetfy enhancement intervention performed significantly better in a subsequent simulation than students who did not have prior simulation experience (p < .001).
","['undergraduate-nursing curriculum', 'Third-year BSN students (n\xa0=\xa083', 'undergraduate nursing students']",['standard training while the intervention group received additional clinical simulation experience and debriefing sessions'],"['Post-test knowledge scores', 'Medication Safety Critical Element Checklist (MSCEC']","[{'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1098180', 'cui_str': 'bis((di-n-butyl 3,6-dioxaheptanoato)tin)'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0038496', 'cui_str': 'Student nurse'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0013879', 'cui_str': 'Chemical element'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}]",83.0,0.0131788,"Students who received the medication safetfy enhancement intervention performed significantly better in a subsequent simulation than students who did not have prior simulation experience (p < .001).
","[{'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Craig', 'Affiliation': 'University of Virginia, School of Nursing, Charlottesville, VA, USA. Electronic address: sjw5y@virginia.edu.'}, {'ForeName': 'Jennifer C', 'Initials': 'JC', 'LastName': 'Kastello', 'Affiliation': 'University of Virginia, School of Nursing, Charlottesville, VA, USA. Electronic address: jck9e@virginia.edu.'}, {'ForeName': 'Bethany J', 'Initials': 'BJ', 'LastName': 'Cieslowski', 'Affiliation': 'University of Virginia, School of Nursing, Charlottesville, VA, USA. Electronic address: bjc6h@virginia.edu.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Rovnyak', 'Affiliation': 'University of Virginia, School of Nursing, Charlottesville, VA, USA.'}]",Nurse education today,['10.1016/j.nedt.2020.104605']
2159,33096392,Tocolysis compared with no tocolysis in women with threatened preterm birth and ruptured membranes: A propensity score analysis.,"INTRODUCTION


In women with preterm ruptured membranes and contractions, the administration of tocolysis is controversial. This study compares tocolysis with no tocolysis in women with threatened preterm birth and ruptured membranes.
OBJECTIVE


To compare tocolysis with no tocolysis in women with threatened preterm birth and ruptured membranes.
STUDY DESIGN


Data from the APOSTEL III RCT was combined with data from the National Maternity Hospital, Dublin. In the APOSTEL III trial, women with threatened preterm birth were randomized to atosiban or nifedipine. Patient data from Ireland were obtained from a cohort of women with threatened preterm birth with ruptured membranes. The Irish women received no tocolytic treatment. Only women with ruptured membranes and contractions were selected. We studied women with singleton or twin pregnancies and a gestational age between 25 +0  and 33 +6  weeks. Propensity score matching was performed to create comparable groups. Primary outcome was a composite adverse neonatal outcome. Secondary outcomes were individual components of the primary outcome, as well as neonatal intensive care unit (NICU) admission, gestational age at delivery, prolongation of pregnancy and mode of delivery.
RESULTS


153 women from the Apostel III trial were compared with 51 eligible women of the Irish cohort. We could match 46 women who received tocolysis and 46 women who received no tocolysis. All women had ruptured membranes. Maternal age, BMI, parity and gestational age at study entry were comparable between the groups after matching. There were no statistically significant differences in neonatal composite outcome (9.6 % in the tocolysis group versus 18 % in the control group, OR 0.46, 95 % CI 0.13-1.63). We found a lower incidence of NICU admission in the tocolysis group (63 %) than in the control group (94 %; OR 0.11, 95 % CI 0.03-0.41), which could be explained by differences in national admission policies. There were no statistically significant differences between tocolysis and no tocolysis in any of the other outcomes including sepsis, gestational age at delivery and time to delivery.
CONCLUSION


In this propensity score analysis of women with threatened preterm birth and ruptured membranes, tocolytic therapy did not alter composite adverse neonatal outcome or time to delivery.",2020,"There were no statistically significant differences between tocolysis and no tocolysis in any of the other outcomes including sepsis, gestational age at delivery and time to delivery.
","['women with threatened preterm birth with ruptured membranes', 'women with singleton or twin pregnancies and a gestational age between 25 +0  and 33 +6  weeks', 'women with threatened preterm birth and ruptured membranes', 'All women had ruptured membranes', '153 women from the Apostel III trial were compared with 51 eligible women of the Irish cohort', 'Data from the APOSTEL III RCT was combined with data from the National Maternity Hospital, Dublin', '46 women who received tocolysis and 46 women who received', 'women with threatened preterm birth']","['Tocolysis', 'tocolysis with no tocolysis', 'nifedipine', 'no tocolysis']","['sepsis, gestational age at delivery and time to delivery', 'neonatal intensive care unit (NICU) admission, gestational age at delivery, prolongation of pregnancy and mode of delivery', 'neonatal composite outcome', 'NICU admission', 'composite adverse neonatal outcome']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0233308', 'cui_str': 'Spontaneous rupture of fetal membranes'}, {'cui': 'C0152150', 'cui_str': 'Twin pregnancy'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1553352', 'cui_str': 'Irish Gaelic language'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0020010', 'cui_str': 'Maternity Hospitals'}, {'cui': 'C0454777', 'cui_str': 'Dublin'}, {'cui': 'C0040348', 'cui_str': 'Tocolysis'}]","[{'cui': 'C0040348', 'cui_str': 'Tocolysis'}, {'cui': 'C0028066', 'cui_str': 'Nifedipine'}]","[{'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",153.0,0.295046,"There were no statistically significant differences between tocolysis and no tocolysis in any of the other outcomes including sepsis, gestational age at delivery and time to delivery.
","[{'ForeName': 'T M S', 'Initials': 'TMS', 'LastName': 'van Winden', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Obstetrics, Amsterdam Reproduction and Development Research Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Roos', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Obstetrics, Amsterdam Reproduction and Development Research Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'T A J', 'Initials': 'TAJ', 'LastName': 'Nijman', 'Affiliation': 'Leiden University Medical Centre, Department of Obstetrics and Gynecology, Leiden, the Netherlands.'}, {'ForeName': 'C E', 'Initials': 'CE', 'LastName': 'Kleinrouweler', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Obstetrics, Amsterdam Reproduction and Development Research Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Olaru', 'Affiliation': 'UCD Perinatal Research Centre, School of Medicine, University College Dublin, National Maternity Hospital, Ireland.'}, {'ForeName': 'B W', 'Initials': 'BW', 'LastName': 'Mol', 'Affiliation': 'Department of Obstetrics and Gynaecology, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'F M', 'Initials': 'FM', 'LastName': 'McAuliffe', 'Affiliation': 'UCD Perinatal Research Centre, School of Medicine, University College Dublin, National Maternity Hospital, Ireland.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Pajkrt', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Obstetrics, Amsterdam Reproduction and Development Research Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Oudijk', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Obstetrics, Amsterdam Reproduction and Development Research Institute, Amsterdam, the Netherlands. Electronic address: m.a.oudijk@amsterdamumc.nl.'}]","European journal of obstetrics, gynecology, and reproductive biology",['10.1016/j.ejogrb.2020.10.015']
2160,33096556,Associations of human milk oligosaccharides and bioactive proteins with infant growth and development among Malawian mother-infant dyads.,"BACKGROUND


Human milk oligosaccharides (HMOs) and bioactive breast milk proteins have many beneficial properties. Information is sparse regarding associations between these milk constituents and infant growth and development in lower-income countries.
OBJECTIVES


We aimed to examine associations of milk content of HMOs and bioactive proteins at 6 mo postpartum with infant growth and motor and cognitive development. These are secondary analyses of a randomized controlled trial in rural Malawi.
METHODS


Breast milk samples were analyzed at 6 mo (n = 659) for general categories of HMOs (total HMOs, fucosylated HMOs, and sialylated HMOs), 51 individual HMOs, and 6 bioactive proteins (lactalbumin, lactoferrin, lysozyme, antitrypsin, IgA, and osteopontin). We examined associations of the relative abundances of HMOs and concentrations of bioactive proteins with infant growth from 6 to 12 mo [change in length-for-age (ΔLAZ), weight-for-age, weight-for-length, and head circumference z-scores] as well as ability to stand or walk alone at 12 mo, and motor and language skills, socioemotional development, executive function, and working memory at 18 mo. Analyses were adjusted for covariates and multiple hypothesis testing.
RESULTS


Among all participants, there were inverse associations of IgA and lactoferrin concentrations with motor skills (P = 0.018 and P = 0.044), and a positive association of lactalbumin concentration with motor skills (P = 0.038). Among secretors only [fucosyltransferase 2 gene (FUT2) positive], there were positive associations of absolute abundance of HMOs with ΔLAZ (P = 0.035), and relative abundance of fucosylated and sialylated HMOs with language at 18 mo (P < 0.001 and P = 0.033, respectively), and inverse associations of osteopontin with standing and walking at 12 mo (P = 0.007 and 0.002, respectively). Relative abundances of several individual HMOs were associated with growth and development, mostly among secretors.
CONCLUSIONS


Certain bioactive breast milk proteins and HMOs are associated with infant growth and motor and cognitive development. Further studies are needed to determine if a causal relation exists.This trial was registered at clinicaltrials.gov as NCT01239693.",2020,"Among all participants, there were inverse associations of IgA and lactoferrin concentrations with motor skills (P = 0.018 and P = 0.044), and a positive association of lactalbumin concentration with motor skills (P = 0.038).","['Breast milk samples were analyzed at 6 mo (n\xa0=\xa0659) for general categories of HMOs (total HMOs, fucosylated HMOs, and sialylated HMOs), 51 individual HMOs, and 6 bioactive proteins (lactalbumin, lactoferrin, lysozyme, antitrypsin, IgA, and osteopontin', 'Malawian mother-infant dyads']",[],"['relative abundance of fucosylated and sialylated HMOs with language', 'length-for-age (ΔLAZ), weight-for-age, weight-for-length, and head circumference z-scores', 'lactalbumin concentration with motor skills', 'IgA and lactoferrin concentrations with motor skills']","[{'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0026140', 'cui_str': 'Breast milk'}, {'cui': 'C0028959', 'cui_str': 'Oligosaccharide'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0022912', 'cui_str': 'Lactalbumin'}, {'cui': 'C0022942', 'cui_str': 'Lactoferrin'}, {'cui': 'C0026794', 'cui_str': 'Muramidase'}, {'cui': 'C2713669', 'cui_str': 'SERPINA5 protein, human'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0069676', 'cui_str': 'Osteopontin'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]",[],"[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0026140', 'cui_str': 'Breast milk'}, {'cui': 'C0028959', 'cui_str': 'Oligosaccharide'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0262499', 'cui_str': 'Head circumference'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0022912', 'cui_str': 'Lactalbumin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0026612', 'cui_str': 'Motor Skills'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0022942', 'cui_str': 'Lactoferrin'}]",659.0,0.0487118,"Among all participants, there were inverse associations of IgA and lactoferrin concentrations with motor skills (P = 0.018 and P = 0.044), and a positive association of lactalbumin concentration with motor skills (P = 0.038).","[{'ForeName': 'Josh M', 'Initials': 'JM', 'LastName': 'Jorgensen', 'Affiliation': 'Department of Nutrition, University of California, Davis, CA, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Young', 'Affiliation': 'Department of Nutrition, University of California, Davis, CA, USA.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Ashorn', 'Affiliation': 'Faculty of Medicine and Life Sciences, Centre for Child Health Research, University of Tampere, Tampere, Finland.'}, {'ForeName': 'Ulla', 'Initials': 'U', 'LastName': 'Ashorn', 'Affiliation': 'Faculty of Medicine and Life Sciences, Centre for Child Health Research, University of Tampere, Tampere, Finland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Chaima', 'Affiliation': 'Department of Community Health, University of Malawi College of Medicine, Blantyre, Malawi.'}, {'ForeName': 'Jasmine C C', 'Initials': 'JCC', 'LastName': 'Davis', 'Affiliation': 'Department of Chemistry, University of California, Davis, CA, USA.'}, {'ForeName': 'Elisha', 'Initials': 'E', 'LastName': 'Goonatilleke', 'Affiliation': 'Department of Chemistry, University of California, Davis, CA, USA.'}, {'ForeName': 'Chiza', 'Initials': 'C', 'LastName': 'Kumwenda', 'Affiliation': 'Department of Community Health, University of Malawi College of Medicine, Blantyre, Malawi.'}, {'ForeName': 'Carlito B', 'Initials': 'CB', 'LastName': 'Lebrilla', 'Affiliation': 'Department of Chemistry, University of California, Davis, CA, USA.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Maleta', 'Affiliation': 'Department of Community Health, University of Malawi College of Medicine, Blantyre, Malawi.'}, {'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Prado', 'Affiliation': 'Department of Nutrition, University of California, Davis, CA, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Sadalaki', 'Affiliation': 'Department of Community Health, University of Malawi College of Medicine, Blantyre, Malawi.'}, {'ForeName': 'Sarah M', 'Initials': 'SM', 'LastName': 'Totten', 'Affiliation': 'Department of Chemistry, University of California, Davis, CA, USA.'}, {'ForeName': 'Lauren D', 'Initials': 'LD', 'LastName': 'Wu', 'Affiliation': 'Department of Chemistry, University of California, Davis, CA, USA.'}, {'ForeName': 'Angela M', 'Initials': 'AM', 'LastName': 'Zivkovic', 'Affiliation': 'Department of Nutrition, University of California, Davis, CA, USA.'}, {'ForeName': 'Kathryn G', 'Initials': 'KG', 'LastName': 'Dewey', 'Affiliation': 'Department of Nutrition, University of California, Davis, CA, USA.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa272']
2161,33096557,An Expression of Concern from The Journal of Nutrition's Editorial Office about: High-dose ω-3 Fatty Acid Plus Vitamin D3 Supplementation Affects Clinical Symptoms and Metabolic Status of Patients with Multiple Sclerosis: A Randomized Controlled Clinical Trial.,,2020,,['Patients with Multiple Sclerosis'],['ω-3 Fatty Acid Plus Vitamin D3'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}]","[{'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}]",[],,0.0930488,,"[{'ForeName': 'Ebrahim', 'Initials': 'E', 'LastName': 'Kouchaki', 'Affiliation': ''}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Afarini', 'Affiliation': ''}, {'ForeName': 'Javad', 'Initials': 'J', 'LastName': 'Abolhassani', 'Affiliation': ''}, {'ForeName': 'Naghmeh', 'Initials': 'N', 'LastName': 'Mirhosseini', 'Affiliation': ''}, {'ForeName': 'Fereshteh', 'Initials': 'F', 'LastName': 'Bahmani', 'Affiliation': ''}, {'ForeName': 'Seyed Ali', 'Initials': 'SA', 'LastName': 'Masoud', 'Affiliation': ''}, {'ForeName': 'Zatollah', 'Initials': 'Z', 'LastName': 'Asemi', 'Affiliation': ''}]",The Journal of nutrition,['10.1093/jn/nxaa342']
2162,33096567,Home treatment of pulmonary embolism: are all the questions answered now after the HOME-PE trial?,,2020,,['pulmonary embolism'],[],[],"[{'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}]",[],[],,0.0178576,,"[{'ForeName': 'Stavros V', 'Initials': 'SV', 'LastName': 'Konstantinides', 'Affiliation': 'Center for Thrombosis and Hemostasis (CTH), University Medical Center of the Johannes Gutenberg University, Langenbeckstrasse 1, Building 403, 55131 Mainz, Germany.'}]",Cardiovascular research,['10.1093/cvr/cvaa289']
2163,33096665,"Association between Peak Expiratory Flow Rate and Exposure Level to Indoor PM2.5 in Asthmatic Children, Using Data from the Escort Intervention Study.","Various studies have indicated that particulate matter <2.5 μm (PM2.5) could cause adverse health effects on pulmonary functions in susceptible groups, especially asthmatic children. Although the impact of ambient PM2.5 on children's lower respiratory health has been well-established, information regarding the associations between indoor PM2.5 levels and respiratory symptoms in asthmatic children is relatively limited. This randomized, crossover intervention study was conducted among 26 asthmatic children's homes located in Incheon metropolitan city, Korea. We aimed to evaluate the effects of indoor PM2.5 on children's peak expiratory flow rate (PEFR), with a daily intervention of air purifiers with filter on, compared with those groups with filter off. Children aged between 6-12 years diagnosed with asthma were enrolled and randomly allocated into two groups. During a crossover intervention period of seven weeks, we observed that, in the filter-on group, indoor PM2.5 levels significantly decreased by up to 43%. ( p  < 0.001). We also found that the daily or weekly unit (1 μg/m 3 ) increase in indoor PM2.5 levels could significantly decrease PEFR by 0.2% (95% confidence interval (CI) = 0.1 to 0.5) or PEFR by 1.2% (95% CI = 0.1 to 2.7) in asthmatic children, respectively. The use of in-home air filtration could be considered as an intervention strategy for indoor air quality control in asthmatic children's homes.",2020,"This randomized, crossover intervention study was conducted among 26 asthmatic children's homes located in Incheon metropolitan city, Korea.","['Asthmatic Children', 'Children aged between 6-12 years diagnosed with asthma', ""asthmatic children's homes"", ""26 asthmatic children's homes located in Incheon metropolitan city, Korea"", 'asthmatic children']","['indoor PM2.5', 'ambient PM2.5']","['indoor PM2.5 levels', ""children's peak expiratory flow rate (PEFR"", 'Peak Expiratory Flow Rate and Exposure Level to Indoor PM2.5', 'PEFR']","[{'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0022771', 'cui_str': 'Korea'}]","[{'cui': 'C1720884', 'cui_str': 'Particulate Matter'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C1510837', 'cui_str': 'Air Pollutants, Particulate'}]","[{'cui': 'C1720884', 'cui_str': 'Particulate Matter'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030735', 'cui_str': 'Peak expiratory flow rate'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]",26.0,0.0356171,"This randomized, crossover intervention study was conducted among 26 asthmatic children's homes located in Incheon metropolitan city, Korea.","[{'ForeName': 'Sungroul', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Department of Environmental Sciences, Soonchunhyang University, Asan 31538, Korea.'}, {'ForeName': 'Jungeun', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Environmental Sciences, Soonchunhyang University, Asan 31538, Korea.'}, {'ForeName': 'Sujung', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': 'Department of Environmental Sciences, Soonchunhyang University, Asan 31538, Korea.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Rudasingwa', 'Affiliation': 'Department of Environmental Sciences, Soonchunhyang University, Asan 31538, Korea.'}, {'ForeName': 'Sangwoon', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Department of ICT Environmental Health System, Graduate School, Soonchunhyang University, Asan 31538, Korea.'}, {'ForeName': 'Sol', 'Initials': 'S', 'LastName': 'Yu', 'Affiliation': 'Department of Environmental Sciences, Soonchunhyang University, Asan 31538, Korea.'}, {'ForeName': 'Dae Hyun', 'Initials': 'DH', 'LastName': 'Lim', 'Affiliation': 'Department of Pediatrics, School of Medicine, Inha University, Incheon 22332, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17207667']
2164,33096684,Does the Energy Restriction Intermittent Fasting Diet Alleviate Metabolic Syndrome Biomarkers? A Randomized Controlled Trial.,"The aim of this study was to determine the efficacy of an energy restriction intermittent fasting diet in metabolic biomarkers and weight management among adults with metabolic syndrome. This randomized controlled study was performed with metabolic syndrome patients, aged 18-65 years, at an academic institution in Istanbul, Turkey ( n  = 70). All participants were randomized to the Intermittent Energy Restriction (IER) intervention group and Continuous Energy Restriction (CER) control group. Biochemical tests including lipid profile, fasting plasma glucose, insulin, glycosylated hemoglobin Type A1c (HbA1c), homeostatic model assessment of insulin resistance (HOMA-IR), blood pressure, and body composition were evaluated at baseline and at the 12th week in diet interviews. Dietary intake was measured with the 24-h dietary recall method and dietary quality was evaluated with the Healthy Eating Index-2010. Changes in body weight (≈7% weight loss) and composition were similar in both groups. Blood pressure, total cholesterol, triglyceride, low-density lipoprotein (LDL), fasting glucose, and insulin at the 12th week decreased in both groups ( p  < 0.05). No significant differences were observed in metabolic syndrome biomarkers between the IER and CER groups. The energy-restricted intermittent fasting diet did not cause any deficiencies in macronutrient and fiber intake in the subjects. Healthy Eating Index (HEI) index scores were achieved similarly in both groups, and subjects' dietary intakes were close to daily reference nutritional intake values. The technique used to achieve energy restriction, whether intermittent or continuous, appears to alleviate the metabolic syndrome biomarkers activated by weight loss.",2020,"Healthy Eating Index (HEI) index scores were achieved similarly in both groups, and subjects' dietary intakes were close to daily reference nutritional intake values.","['metabolic syndrome patients, aged 18-65 years, at an academic institution in Istanbul, Turkey ( n  = 70', 'adults with metabolic syndrome']","['energy restriction intermittent fasting diet', 'Intermittent Energy Restriction (IER) intervention group and Continuous Energy Restriction (CER) control group']","['24-h dietary recall method and dietary quality', 'Healthy Eating Index (HEI) index scores', 'Dietary intake', 'body weight', 'Blood pressure, total cholesterol, triglyceride, low-density lipoprotein (LDL), fasting glucose, and insulin', 'metabolic syndrome biomarkers', 'lipid profile, fasting plasma glucose, insulin, glycosylated hemoglobin Type A1c (HbA1c), homeostatic model assessment of insulin resistance (HOMA-IR), blood pressure, and body composition']","[{'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0041400', 'cui_str': 'Turkey - country'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C4704881', 'cui_str': 'Intermittent Fasting'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C4280021', 'cui_str': 'Healthy Eating Index'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}]",,0.0146629,"Healthy Eating Index (HEI) index scores were achieved similarly in both groups, and subjects' dietary intakes were close to daily reference nutritional intake values.","[{'ForeName': 'Yasemin Ergul', 'Initials': 'YE', 'LastName': 'Kunduraci', 'Affiliation': 'Institute of Health Sciences, Nutrition and Dietetics, Istanbul Medipol University, 34815 Istanbul, Turkey.'}, {'ForeName': 'Hanefi', 'Initials': 'H', 'LastName': 'Ozbek', 'Affiliation': 'Department of Pharmacology, Faculty of Medicine, Istanbul Medipol University, 34815 Istanbul, Turkey.'}]",Nutrients,['10.3390/nu12103213']
2165,33092897,Effect of Wii-habilitation on spatiotemporal parameters and upper limb function post-burn in children.,"BACKGROUND


Limb burns can cause different functional disorders that greatly impact one's quality of life.
AIM


The purpose of the current study was to compare the effect of Nintendo Wii sports intervention, and traditional treatment methods on spatiotemporal parameters and upper limb function post-burn in children.
METHODS


Thirty children their age ranging from 7-12 years, with dominant side upper limb burn participated in the study.Vicon3-D motion analysis system and Jebsen hand function test were used to evaluate spatiotemporal parameters (movement duration, peak velocity, and time to peak velocity percentage in three functional tasks) and upper limb function respectively. The children were randomly divided into study and control groups. The study group was rehabilitated with Wii training in addition to traditional therapy, while the control group rehabilitated only with the traditional therapy program. For the study group, the games selected were Wii Bowling, Baseball, and Tennis. Both groups were trained for 60 min daily, three times/week for six weeks. The outcomes were measured pre and post the treatment period.
RESULTS


The whole-time duration and peak velocity improved significantly in the study group across the hand to head task (p = 0.001, p < 0.001, respectively), hand to mouth (p = 0.001), and hand to shoulder (p < 0.001, p = 0.0018, respectively) compared with the control group. The time to peak velocity percentage was enhanced significantly in the study group (p < 0.001) than the control group in all three-measured tasks. Moreover, the Jebsen hand function test improved significantly (p < 0.001) in the study group than in the control group.
CONCLUSION


Wii-habilitation could be advised as an effective tool in the rehabilitation program of children with post-burn injuries.",2020,"Moreover, the Jebsen hand function test improved significantly (p < 0.001) in the study group than in the control group.
","['children', 'children with post-burn injuries', 'Thirty children their age ranging from 7-12 years, with dominant side upper limb burn participated in the study']","['Nintendo Wii sports intervention', 'Wii training in addition to traditional therapy, while the control group rehabilitated only with the traditional therapy program', 'Wii-habilitation']","['spatiotemporal parameters (movement duration, peak velocity, and time to peak velocity percentage in three functional tasks) and upper limb function respectively', 'whole-time duration and peak velocity', 'Jebsen hand function test', 'time to peak velocity percentage']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0006434', 'cui_str': 'Burn injury'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0445480', 'cui_str': 'Dominant side'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0018459', 'cui_str': 'Habilitation'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0451237', 'cui_str': 'Jebsen hand function test'}]",30.0,0.028214,"Moreover, the Jebsen hand function test improved significantly (p < 0.001) in the study group than in the control group.
","[{'ForeName': 'Nadia L', 'Initials': 'NL', 'LastName': 'Radwan', 'Affiliation': 'Department of Biomechanics, Faculty of Physical Therapy, Cairo University, Egypt; Department of Health and Rehabilitation Sciences, College of Applied Medical Sciences, Prince Sattam Bin Abdulaziz University, Kingdom of Saudi Arabia. Electronic address: nadiaradwan18@yahoo.com.'}, {'ForeName': 'Marwa M', 'Initials': 'MM', 'LastName': 'Ibrahim', 'Affiliation': 'Department of Physical Therapy for Pediatrics, Faculty of Physical Therapy, Cairo University, Egypt; Department of Health and Rehabilitation Sciences, College of Applied Medical Sciences, Prince Sattam Bin Abdulaziz University, Kingdom of Saudi Arabia.'}, {'ForeName': 'Waleed S', 'Initials': 'WS', 'LastName': 'Mahmoud', 'Affiliation': 'Department of Health and Rehabilitation Sciences, College of Applied Medical Sciences, Prince Sattam Bin Abdulaziz University, Kingdom of Saudi Arabia; Department of Basic Sciences, Faculty of Physical Therapy, Cairo University, Giza, Egypt.'}]",Burns : journal of the International Society for Burn Injuries,['10.1016/j.burns.2020.09.010']
2166,33092898,"Mortality prognostication scores do not predict long-term, health-related quality of life after burn: A burn model system national database study.","OBJECTIVE


Despite improved mortality rates after burn injury, many patients face significant long-term physical and psychosocial disabilities. We aimed to determine whether commonly used mortality prognostication scores predict long-term, health-related quality of life after burn injury. By doing so, we might add evidence to support goals of care discussions and facilitate shared decision-making efforts in the hours and days after a life-changing injury.
METHODS


We used the multicenter National Institute of Disability, Independent Living and Rehabilitation Research Burn Model System database (1994-2019) to analyze SF-12 physical (PCS) and mental component (MCS) scores among survivors one year after major burn injury. Ninety percent of the observations were randomly assigned to a model development dataset. Multilevel, mixed-effects, linear regression models determined the relationship between revised Baux and Ryan Scores and SF-12 measures. Additionally, we tested a model with disaggregated independent and other covariates easily obtained around the time of index admission: age, sex, race, burn size, inhalation injury. Residuals from the remaining 10% of observations in the validation dataset were examined.
RESULTS


The analysis included 1606 respondents (median age 42 years, IQR 28-53 years; 70% male). Median burn size was 16% TBSA (IQR 6-30) and 13% of respondents sustained inhalation injury. Higher revised Baux and Ryan Scores and age, burn size, and inhalation injury were significantly correlated with lower PCS, but were not correlated with MCS. Female sex, black race, burn size, and inhalation injury correlated with lower MCS. All models poorly explained the variance in SF-12 scores (adjusted r 2  0.01-0.12).
CONCLUSION


Higher revised Baux and Ryan Scores negatively correlated with long-term physical health, but not mental health, after burn injury. Regardless, the models poorly explained the variance in SF-12 scores one year after injury. More accurate models are needed to predict long-term, health-related quality of life and support shared decision-making during acute burn care.",2020,"All models poorly explained the variance in SF-12 scores (adjusted r 2  0.01-0.12).
","['after burn', '1606 respondents (median age 42 years, IQR 28-53 years; 70% male', 'survivors one year after major burn injury']",[],"['mortality rates', 'health-related quality of life', 'Median burn size', 'revised Baux and Ryan Scores and SF-12 measures', 'Mortality prognostication scores', 'Higher revised Baux and Ryan Scores and age, burn size, and inhalation injury', 'Higher revised Baux and Ryan Scores', 'SF-12 physical (PCS) and mental component (MCS) scores', 'SF-12 scores']","[{'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0006434', 'cui_str': 'Burn injury'}]",[],"[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0745334', 'cui_str': 'Inhalation injury'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449432', 'cui_str': 'Component'}]",,0.0493262,"All models poorly explained the variance in SF-12 scores (adjusted r 2  0.01-0.12).
","[{'ForeName': 'Barclay T', 'Initials': 'BT', 'LastName': 'Stewart', 'Affiliation': 'Department of Surgery, University of Washington, Northwest Regional Burn Model System; Northwest Regional Burn Model System. Electronic address: barclays@uw.edu.'}, {'ForeName': 'Gretchen J', 'Initials': 'GJ', 'LastName': 'Carrougher', 'Affiliation': 'Northwest Regional Burn Model System.'}, {'ForeName': 'Elleanor', 'Initials': 'E', 'LastName': 'Curtis', 'Affiliation': 'Department of Surgery, University of California Davis Health, Department of Palliative Care, University of California Davis Health.'}, {'ForeName': 'Jeffrey C', 'Initials': 'JC', 'LastName': 'Schneider', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Harvard Medical School, Boston-Harvard Burn Injury Model System.'}, {'ForeName': 'Colleen M', 'Initials': 'CM', 'LastName': 'Ryan', 'Affiliation': 'Department of Surgery, Harvard Medical School, Boston-Harvard Burn Injury Model System.'}, {'ForeName': 'Dagmar', 'Initials': 'D', 'LastName': 'Amtmann', 'Affiliation': 'Department of Rehabilitation Medicine, University of Washington, Burn Model System.'}, {'ForeName': 'Nicole S', 'Initials': 'NS', 'LastName': 'Gibran', 'Affiliation': 'Department of Surgery, University of Washington, Northwest Regional Burn Model System; Northwest Regional Burn Model System.'}]",Burns : journal of the International Society for Burn Injuries,['10.1016/j.burns.2020.09.007']
2167,33092986,Low-fidelity otoscopy simulation and anatomy training: A randomized controlled trial.,"OBJECTIVES


To evaluate whether the use of low-fidelity otoscopy simulation improved medical students' theoretical knowledge of middle ear anatomy and pathologies compared to traditional teaching methods.
METHODS


This was a randomized controlled trial. Simulation workshops were conducted in April 2019 in the Lyon Sud University medical faculty, France. Students were randomly assigned to the simulation group (n=105) or to the control group (n=95). The students in the control group answered a questionnaire evaluating theoretical knowledge (25 true-false questions) before the simulation tutorial, while the students in the simulation group answered the same questions after the tutorial. Both groups also filled out a satisfaction questionnaire for feedback.
RESULTS


196 of the 200 students who participated in the study completed the knowledge assessment questionnaire. Scores were 32.0% higher in the simulation group than in the control group (mean scores, 12.0/20 vs. 9.1/20; P<0.0001). 184 of the 191 students who completed the satisfaction questionnaire (96.3%) were satisfied or very satisfied with the workshop, and all but one (99.5%) recommended keeping it in the curriculum. In the free comments fields, students highlighted the educational value of learning without the stress of patient discomfort.
CONCLUSION


Otoscopy simulation is an effective training method, improving theoretical knowledge compared with conventional theoretical training.",2020,"Scores were 32.0% higher in the simulation group than in the control group (mean scores, 12.0/20 vs. 9.1/20; P<0.0001).","['184 of the 191 students who completed the', 'Simulation workshops were conducted in April 2019 in the Lyon Sud University medical faculty, France', '196 of the 200 students who participated in the study completed the knowledge assessment questionnaire']","['questionnaire evaluating theoretical knowledge', 'low-fidelity otoscopy simulation', 'Low-fidelity otoscopy simulation and anatomy training', 'Otoscopy simulation']",['satisfaction questionnaire'],"[{'cui': 'C4517616', 'cui_str': '184'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0015537', 'cui_str': 'Faculties, Medical'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0847244', 'cui_str': 'Endoscopy of ear'}, {'cui': 'C0002808', 'cui_str': 'Anatomy'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.0466222,"Scores were 32.0% higher in the simulation group than in the control group (mean scores, 12.0/20 vs. 9.1/20; P<0.0001).","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Fieux', 'Affiliation': ""Service d'otologie et otoneurologie, Hospices Civils de Lyon, centre hospitalier Lyon Sud, université de Lyon, université Claude Bernard Lyon 1, 69495 Pierre-Bénite, France. Electronic address: maxime.fieux@chu-lyon.fr.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Zaouche', 'Affiliation': ""Service d'otologie et otoneurologie, Hospices Civils de Lyon, centre hospitalier Lyon Sud, université de Lyon, université Claude Bernard Lyon 1, 69495 Pierre-Bénite, France.""}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Philouze', 'Affiliation': ""Service d'ORL et chirurgie cervico faciale, Hospices Civils de Lyon, hôpital de la Croix Rousse, université de Lyon, université Claude Bernard Lyon 1, 69004 Lyon, France.""}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Truy', 'Affiliation': ""Service d'ORL, de chirurgie cervico faciale et d'audiophonologie, Hospices Civils de Lyon, hôpital Edouard Herriot, université de Lyon, université Claude Bernard Lyon 1, 69003 Lyon, France.""}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Hermann', 'Affiliation': ""Service d'ORL, de chirurgie cervico faciale et d'audiophonologie, Hospices Civils de Lyon, hôpital Edouard Herriot, université de Lyon, université Claude Bernard Lyon 1, 69003 Lyon, France.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Tringali', 'Affiliation': ""Service d'otologie et otoneurologie, Hospices Civils de Lyon, centre hospitalier Lyon Sud, université de Lyon, université Claude Bernard Lyon 1, 69495 Pierre-Bénite, France.""}]","European annals of otorhinolaryngology, head and neck diseases",['10.1016/j.anorl.2020.09.010']
2168,33093013,Myofunctional Therapy App for Severe Apnea-Hypopnea Sleep Obstructive Syndrome: A Pilot Randomized Controlled Trial.,"BACKGROUND


Background: Myofunctional therapy has demonstrated efficacy in treating sleep-disordered breathing. We assessed the clinical use of a new mobile health (mHealth) app that uses a smartphone to teach patients with severe obstructive sleep apnea-hypopnea syndrome (OSAHS) to perform oropharyngeal exercises.
OBJECTIVE


We conducted a pilot randomized trial to evaluate the effects of the app in patients with severe OSAHS.
METHODS


Forty patients with severe OSAHS (apnea-hypoxia index [AHI] >30) were enrolled prospectively and randomized into an intervention group that used the app for 90 sessions or a control group. Anthropometric measures, Epworth Sleepiness Scale (0-24), Pittsburgh Sleep Quality Index (0-21), and Iowa Oral Performance Instrument (IOPI) scores, and oxygen desaturation index were obtained before and after the intervention.
RESULTS


After the intervention, 28 patients remained. No significant changes were observed in the control group. The intervention group showed significant improvements. AHI decreased 53.4% from 44.7 (range 33.8-55.6) to 20.88 (14.02-27.7) events/h (P<.001). Oxygen desaturation index decreased 46.5% from 36.31 (27.19-43.43) to 19.4 (12.9-25.98) events/h (P=.003). IOPI maximum tongue score increased from 39.83 (35.32-45.2) to 59.06 (54.74-64.00) kPa (P<.001). IOPI maximum lip score increased from 27.89 (24.16-32.47) to 44.11 (39.5-48.8) kPa (P<.001). The AHI correlated significantly with IOPI tongue and lip improvements (Pearson coefficient -0.56, P<.001, and -0.46, P<.001, respectively). The Epworth Sleepiness Scale score decreased from 10.33 (8.71-12.24) to 5.37 (3.45-7.28) (P<.001) in the app group, but the Pittsburgh Sleep Quality Index did not change significantly.
CONCLUSIONS


Orofacial exercises performed using an mHealth app reduce OSAHS severity and symptoms, and represent a promising treatment for OSAHS.
CLINICALTRIAL


Spanish Gov AWGAPN-2019-01; ClinicalTrials.gov NCT04438785.",2020,IOPI maximum tongue score increased from 39.83 (35.32-45.2) to 59.06,"['Severe Apnea-Hypopnea Sleep Obstructive Syndrome', 'Forty patients with severe OSAHS (apnea-hypoxia index [AHI] >30', 'patients with severe obstructive sleep apnea-hypopnea syndrome (OSAHS', 'patients with severe OSAHS']","['Myofunctional Therapy App', 'Myofunctional therapy']","['Oxygen desaturation index', 'IOPI maximum tongue score', 'IOPI tongue and lip improvements', 'AHI', 'Pittsburgh Sleep Quality Index', 'IOPI maximum lip score', 'Epworth Sleepiness Scale score', 'Anthropometric measures, Epworth Sleepiness Scale (0-24), Pittsburgh Sleep Quality Index (0-21), and Iowa Oral Performance Instrument (IOPI) scores, and oxygen desaturation index']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0235546', 'cui_str': 'Slow shallow breathing'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4285910', 'cui_str': 'Obstructive sleep apnea hypopnea syndrome'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]","[{'cui': 'C0600516', 'cui_str': 'Oral Myotherapy'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}]","[{'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0022037', 'cui_str': 'Iowa'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0040408', 'cui_str': 'Tongue structure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0023759', 'cui_str': 'Lip structure'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C4706348', 'cui_str': 'ESS (Epworth Sleepiness Scale) score'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C3541276', 'cui_str': 'Epworth Sleepiness Scale'}]",40.0,0.0974474,IOPI maximum tongue score increased from 39.83 (35.32-45.2) to 59.06,"[{'ForeName': 'Carlos', 'Initials': 'C', 'LastName': ""O'Connor-Reina"", 'Affiliation': 'Hospital quironsalud marbella, Department otolaryngology, avd severo ochoa 22, marbella, ES.'}, {'ForeName': 'Jose Maria', 'Initials': 'JM', 'LastName': 'Ignacio-Garcia', 'Affiliation': 'Hospital Quironsalud Marbella and Campo de Gibraltar, Head Neumology Departments, Marbella, ES.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Rodriguez-Ruiz', 'Affiliation': 'Hospital Quironsalud Marbella Neumology Department, Marbella, ES.'}, {'ForeName': 'Maria Del Carmen', 'Initials': 'MDC', 'LastName': 'Morillo Dominguez', 'Affiliation': 'Hospital Quironsalud Marbella Neumology Department, Marbella, ES.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Ignacio Barrios', 'Affiliation': 'Hospital Quironsalud Marbella and Campo de Gibraltar, Neumology Department, Palmones, ES.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Baptista Jardin', 'Affiliation': 'Otolaryngology Department Clinica Universitaria de Navarra, Pamplona, ES.'}, {'ForeName': 'Juan Carlos', 'Initials': 'JC', 'LastName': 'Casado Morente', 'Affiliation': 'Hospital Quironsalud Marbella and Hospital Quironsalud Campo de Gibraltar, Department otolaryngology, marbella, ES.'}, {'ForeName': 'Maria Teresa', 'Initials': 'MT', 'LastName': 'Garcia Iriarte', 'Affiliation': 'Otolaryngology Department. Hospital la Merced, Osuna, ES.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Plaza', 'Affiliation': 'Hospital Sanitas la Zarzuela, Otolaryngology Department, Madrid, ES.'}]",JMIR mHealth and uHealth,['10.2196/23123']
2169,33093030,'Be on the TEAM' Study (Teenagers Against Meningitis): protocol for a controlled clinical trial evaluating the impact of 4CMenB or MenB-fHbp vaccination on the pharyngeal carriage of meningococci in adolescents.,"INTRODUCTION


Capsular group B  Neisseria meningitidis  (MenB) is the most common cause of invasive meningococcal disease (IMD) in many parts of the world. A MenB vaccine directed against the polysaccharide capsule remains elusive due to poor immunogenicity and safety concerns. The vaccines licensed for the prevention of MenB disease, 4CMenB (Bexsero) and MenB-fHbp (Trumenba), are serogroup B 'substitute' vaccines, comprised of subcapsular proteins and are designed to provide protection against most MenB disease-causing strains. In many high-income countries, such as the UK, adolescents are at increased risk of IMD and have the highest rates of meningococcal carriage. Beginning in the late 1990s, immunisation of this age group with the meningococcal group C conjugate vaccine reduced asymptomatic carriage and disrupted transmission of this organism, resulting in lower group C IMD incidence across all age groups. Whether vaccinating teenagers with the novel 'MenB' protein-based vaccines will prevent acquisition or reduce duration of carriage and generate herd protection was unknown at the time of vaccine introduction and could not be inferred from the effects of the conjugate vaccines. 4CMenB and MenB-fHbp may also impact on non-MenB disease-causing capsular groups as well as commensal  Neisseria  spp. This study will evaluate the impact of vaccination with 4CMenB or MenB-fHbp on oropharyngeal carriage of pathogenic meningococci in teenagers, and consequently the potential for these vaccines to provide broad community protection against MenB disease.
METHODS AND ANALYSIS


The 'Be on the TEAM' (Teenagers Against Meningitis) Study is a pragmatic, partially randomised controlled trial of 24 000 students aged 16-19 years in their penultimate year of secondary school across the UK with regional allocation to a 0+6 month schedule of 4CMenB or MenB-fHbp or to a control group. Culture-confirmed oropharyngeal carriage will be assessed at baseline and at 12 months, following which the control group will be eligible for 4CMenB vaccination. The primary outcome is the carriage prevalence of potentially pathogenic meningococci (defined as those with genogroups B, C, W, Y or X), in each vaccine group compared separately to the control group at 12 months post-enrolment, that is, 12 months after the first vaccine dose and 6 months after the second vaccine dose. Secondary outcomes include impact on carriage of: genogroup B meningococci; hyperinvasive meningococci; all meningococci; those meningococci expressing vaccine antigens and; other  Neisseria  spp. A sample size of 8000 in each arm will provide 80% power to detect a 30% reduction in meningococcal carriage, assuming genogroup B, C, W, Y or X meningococci carriage of 3.43%, a design effect of 1.5, a retention rate of 80% and a significance level of 0.05. Study results will be available in 2021 and will inform the UK and international immunisation policy and future vaccine development.
ETHICS AND DISSEMINATION


This study is approved by the National Health Service South Central Research Ethics Committee (18/SC/0055); the UK Health Research Authority (IRAS ID 239091) and the UK Medicines and Healthcare products Regulatory Agency. Publications arising from this study will be submitted to peer-reviewed journals. Study results will be disseminated in public forums, online, presented at local and international conferences and made available to the participating schools.
TRIAL REGISTRATION NUMBERS


ISRCTN75858406; Pre-results, EudraCT 2017-004609-42.",2020,Whether vaccinating teenagers with the novel 'MenB' protein-based vaccines will prevent acquisition or reduce duration of carriage and generate herd protection was unknown at the time of vaccine introduction and could not be inferred from the effects of the conjugate vaccines.,"['pharyngeal carriage of meningococci in adolescents', 'oropharyngeal carriage of pathogenic meningococci in teenagers', 'Teenagers Against Meningitis', '24\u2009000 students aged 16-19\u2009years in their penultimate year of secondary school across the UK with regional allocation to a 0+6\u2009month schedule of 4CMenB or MenB-fHbp or to a control group']","['Capsular group B  Neisseria meningitidis  (MenB', '4CMenB or MenB-fHbp vaccination', '4CMenB or MenB-fHbp']","['carriage prevalence of potentially pathogenic meningococci (defined as those with genogroups B, C, W, Y or X', 'carriage of: genogroup B meningococci; hyperinvasive meningococci; all meningococci; those meningococci expressing vaccine antigens and; other  Neisseria  spp']","[{'cui': 'C0031354', 'cui_str': 'Pharyngeal structure'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C0450254', 'cui_str': 'Pathogenic organism'}, {'cui': 'C0025289', 'cui_str': 'Meningitis'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0036530', 'cui_str': 'Secondary school'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205151', 'cui_str': 'Capsular'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0027571', 'cui_str': 'Neisseria'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0450254', 'cui_str': 'Pathogenic organism'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C3661526', 'cui_str': 'Genogroup'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0003320', 'cui_str': 'Antigen'}, {'cui': 'C0027571', 'cui_str': 'Neisseria'}, {'cui': 'C0074992', 'cui_str': 'sphingosine 1-phosphate'}]",24000.0,0.184134,Whether vaccinating teenagers with the novel 'MenB' protein-based vaccines will prevent acquisition or reduce duration of carriage and generate herd protection was unknown at the time of vaccine introduction and could not be inferred from the effects of the conjugate vaccines.,"[{'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Carr', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK jeremy.carr@paediatrics.ox.ac.uk.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Plested', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Parvinder', 'Initials': 'P', 'LastName': 'Aley', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Camara', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Davis', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Jenny M', 'Initials': 'JM', 'LastName': 'MacLennan', 'Affiliation': 'Department of Zoology, University of Oxford, Oxford, UK.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Gray', 'Affiliation': 'Meningococcal Reference Unit, Public Health England, Manchester Royal Infirmary, Manchester, UK.'}, {'ForeName': 'Saul N', 'Initials': 'SN', 'LastName': 'Faust', 'Affiliation': 'NIHR Southampton Clinical Research Facility and NIHR Southampton Biomedical Research Centre, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Ray', 'Initials': 'R', 'LastName': 'Borrow', 'Affiliation': 'Meningococcal Reference Unit, Public Health England, Manchester Royal Infirmary, Manchester, UK.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Christensen', 'Affiliation': 'School of Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Trotter', 'Affiliation': 'Department of Veterinary Medicine, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Martin C J', 'Initials': 'MCJ', 'LastName': 'Maiden', 'Affiliation': 'Department of Zoology, University of Oxford, Oxford, UK.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Finn', 'Affiliation': 'School of Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Snape', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2020-037358']
2170,33093036,Development and internal validation of prognostic models to predict negative health outcomes in older patients with multimorbidity and polypharmacy in general practice.,"BACKGROUND


Polypharmacy interventions are resource-intensive and should be targeted to those at risk of negative health outcomes. Our aim was to develop and internally validate prognostic models to predict health-related quality of life (HRQoL) and the combined outcome of falls, hospitalisation, institutionalisation and nursing care needs, in older patients with multimorbidity and polypharmacy in general practices.
METHODS


Design : two independent data sets, one comprising health insurance claims data (n=592 456), the other data from the PRIoritising MUltimedication in Multimorbidity (PRIMUM) cluster randomised controlled trial (n=502).  Population : ≥60 years, ≥5 drugs, ≥3 chronic diseases, excluding dementia.  Outcomes : combined outcome of falls, hospitalisation, institutionalisation and nursing care needs (after 6, 9 and 24 months) (claims data); and HRQoL (after 6 and 9 months) (trial data).  Predictor variables in both data sets : age, sex, morbidity-related variables (disease count), medication-related variables (European Union-Potentially Inappropriate Medication list (EU-PIM list)) and health service utilisation.  Predictor variables exclusively in trial data : additional socio-demographics, morbidity-related variables (Cumulative Illness Rating Scale, depression), Medication Appropriateness Index (MAI), lifestyle, functional status and HRQoL (EuroQol EQ-5D-3L).  Analysis : mixed regression models, combined with stepwise variable selection, 10-fold cross validation and sensitivity analyses.
RESULTS


Most important predictors of EQ-5D-3L at 6 months in best model (Nagelkerke's R² 0.507) were depressive symptoms (-2.73 (95% CI: -3.56 to -1.91)), MAI (-0.39 (95% CI: -0.7 to -0.08)), baseline EQ-5D-3L (0.55 (95% CI: 0.47 to 0.64)). Models based on claims data and those predicting long-term outcomes based on both data sets produced low R² values. In claims data-based model with highest explanatory power (R²=0.16), previous falls/fall-related injuries, previous hospitalisations, age, number of involved physicians and disease count were most important predictor variables.
CONCLUSIONS


Best trial data-based model predicted HRQoL after 6 months well and included parameters of well-being not found in claims. Performance of claims data-based models and models predicting long-term outcomes was relatively weak. For generalisability, future studies should refit models by considering parameters representing well-being and functional status.",2020,"In claims data-based model with highest explanatory power (R²=0.16), previous falls/fall-related injuries, previous hospitalisations, age, number of involved physicians and disease count were most important predictor variables.
","['older patients with multimorbidity and polypharmacy in general practice', 'Population : ≥60 years, ≥5 drugs, ≥3 chronic diseases, excluding dementia', 'Design : two independent data sets, one comprising health insurance claims data (n=592 456), the other data from the PRIoritising MUltimedication in Multimorbidity (PRIMUM) cluster randomised controlled trial (n=502', 'older patients with multimorbidity and polypharmacy in general practices']",[],"['MAI', 'sex, morbidity-related variables (disease count), medication-related variables (European Union-Potentially Inappropriate Medication list (EU-PIM list)) and health service utilisation', 'falls, hospitalisation, institutionalisation and nursing care needs (after 6, 9 and 24 months) (claims data); and HRQoL', 'socio-demographics, morbidity-related variables (Cumulative Illness Rating Scale, depression), Medication Appropriateness Index (MAI), lifestyle, functional status and HRQoL (EuroQol EQ-5D-3L', 'depressive symptoms', 'baseline EQ-5D-3L']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1535889', 'cui_str': 'Multimorbidity'}, {'cui': 'C2922974', 'cui_str': 'Polypharmacy'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0150098', 'cui_str': 'Data Set'}, {'cui': 'C0021682', 'cui_str': 'Health Insurance'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],"[{'cui': 'C0026914', 'cui_str': 'Mycobacterium avium-intracellulare'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0015179', 'cui_str': 'European Community'}, {'cui': 'C4042848', 'cui_str': 'PIM List'}, {'cui': 'C0018747', 'cui_str': 'Services, Health'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0028678', 'cui_str': 'nursing'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C4046084', 'cui_str': 'Medication Appropriateness Index'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",,0.0935162,"In claims data-based model with highest explanatory power (R²=0.16), previous falls/fall-related injuries, previous hospitalisations, age, number of involved physicians and disease count were most important predictor variables.
","[{'ForeName': 'Beate S', 'Initials': 'BS', 'LastName': 'Müller', 'Affiliation': 'Institute of General Practice, Goethe University Frankfurt, Frankfurt am Main, Hessen, Germany b.mueller@allgemeinmedizin.uni-frankfurt.de.'}, {'ForeName': 'Lorenz', 'Initials': 'L', 'LastName': 'Uhlmann', 'Affiliation': 'Institute of Medical Biometry and Informatics, University of Heidelberg, Heidelberg, Baden-Württemberg, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Ihle', 'Affiliation': 'PMV Research Group, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Nordrhein-Westfalen, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Stock', 'Affiliation': 'Institute of Medical Biometry and Informatics, University of Heidelberg, Heidelberg, Baden-Württemberg, Germany.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'von Buedingen', 'Affiliation': 'Institute of General Practice, Goethe University Frankfurt, Frankfurt am Main, Hessen, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Beyer', 'Affiliation': 'Institute of General Practice, Goethe University Frankfurt, Frankfurt am Main, Hessen, Germany.'}, {'ForeName': 'Ferdinand M', 'Initials': 'FM', 'LastName': 'Gerlach', 'Affiliation': 'Institute of General Practice, Goethe University Frankfurt, Frankfurt am Main, Hessen, Germany.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Perera', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, Oxfordshire, UK.'}, {'ForeName': 'Jose Maria', 'Initials': 'JM', 'LastName': 'Valderas', 'Affiliation': 'APEx Collaboration for Academic Primary Care, University of Exeter Medical School, Exeter, Devon, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Glasziou', 'Affiliation': 'Centre for Research in Evidence-Based Practice, Faculty of Health Sciences and Medicine, Bond University, Gold Coast, Queensland, Australia.'}, {'ForeName': 'Marjan', 'Initials': 'M', 'LastName': 'van den Akker', 'Affiliation': 'Institute of General Practice, Goethe University Frankfurt, Frankfurt am Main, Hessen, Germany.'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Muth', 'Affiliation': 'Institute of General Practice, Goethe University Frankfurt, Frankfurt am Main, Hessen, Germany.'}]",BMJ open,['10.1136/bmjopen-2020-039747']
2171,33093718,Comparative Effect between Infiltration of Platelet-rich Plasma and the Use of Corticosteroids in the Treatment of Knee Osteoarthritis: A Prospective and Randomized Clinical Trial.,"Objectives   This study aimed to analyze the efficacy of platelet-rich plasma obtained from the peripheral, autologous blood of the patients in pain complaints reduction and functional improvement of knee osteoarthritis compared with the standard treatment with injectable corticosteroid, such as triamcinolone.  Methods   The patients were followed-up clinically at the preinfiltrative visit, with quantitative evaluation using the Knee Society Score (KSS), the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score, and the Kellgren and Lawrence scales. In addition, they were reevaluated with the same scales after 1 month and 6 months of intervention with 2.5 mL of triamcinolone acetate or 5 mL of platelet-rich plasma. The study was performed on 50 patients with knee osteoarthritis treated at the Medical Specialty Center and randomly divided into equivalent samples for each therapy.  Results   The present study verified the reduction of pain scores, such as the WOMAC score, and elevations of functional scales, such as the KSS, evidenced in 180 days when using platelet-rich plasma, a therapy that uses the autologous blood of the patient and has fewer side effects.  Conclusion   Although both platelet-rich plasma and corticosteroid therapies have been shown to be effective in the reduction pain complaints and functional recovery, there was a statistically significant difference between them at 180 days. According to the results obtained, platelet-rich plasma presented longer-lasting effects within 180 days in the treatment of knee osteoarthritis.",2020,"According to the results obtained, platelet-rich plasma presented longer-lasting effects within 180 days in the treatment of knee osteoarthritis.","['Knee Osteoarthritis', '50 patients with knee osteoarthritis treated at the Medical Specialty Center and randomly divided into equivalent samples for each therapy']","['triamcinolone acetate', 'injectable corticosteroid, such as triamcinolone', 'Corticosteroids']","['reduction pain complaints and functional recovery', 'Knee Society Score (KSS), the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score, and the Kellgren and Lawrence scales', 'pain scores, such as the WOMAC score, and elevations of functional scales']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0037778', 'cui_str': 'Medical specialty'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0040864', 'cui_str': 'Triamcinolone'}, {'cui': 'C0000975', 'cui_str': 'Acetate'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0599766', 'cui_str': 'Recovery of Function'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]",50.0,0.0208721,"According to the results obtained, platelet-rich plasma presented longer-lasting effects within 180 days in the treatment of knee osteoarthritis.","[{'ForeName': 'Marianna Ribeiro de Menezes', 'Initials': 'MRM', 'LastName': 'Freire', 'Affiliation': 'Faculty of Medicine, Universidade Tiradentes (Unitmed), Aracaju, SE, Brazil.'}, {'ForeName': 'Philippe Mota Coutinho', 'Initials': 'PMC', 'LastName': 'da Silva', 'Affiliation': 'Faculty of Medicine, Universidade Tiradentes (Unitmed), Aracaju, SE, Brazil.'}, {'ForeName': 'Arthur Rangel', 'Initials': 'AR', 'LastName': 'Azevedo', 'Affiliation': 'Instituto de Assistência Médica ao Servidor Público Estadual de São Paulo (Iamspe), São Paulo, SP, Brazil.'}, {'ForeName': 'Denison Santos', 'Initials': 'DS', 'LastName': 'Silva', 'Affiliation': 'Universidade Tiradentes (Unitmed), Aracaju, SE, Brazil.'}, {'ForeName': 'Ronald Bispo Barreto', 'Initials': 'RBB', 'LastName': 'da Silva', 'Affiliation': 'Universidade Tiradentes (Unitmed), Aracaju, SE, Brazil.'}, {'ForeName': 'Juliana Cordeiro', 'Initials': 'JC', 'LastName': 'Cardoso', 'Affiliation': 'Universidade Tiradentes (Unitmed), Aracaju, SE, Brazil.'}]",Revista brasileira de ortopedia,['10.1016/j.rbo.2018.01.001']
2172,33093783,The effect of the walk-bike on quality of life and exercise capacity in patients with idiopathic pulmonary fibrosis: a feasibility study.,"Idiopathic pulmonary fibrosis (IPF) is characterized by progressive loss of pulmonary function and exercise capacity, leading to loss of quality of life and often social isolation. A new walking aid, the walk-bike, showed an improvement in exercise performance in COPD patients. Aims of this pilot study were to evaluate feasibility of a homebased walk-bike intervention study in IPF patients and to explore the effect of the walk-bike on quality of life (QoL) and exercise capacity. Twenty-three patients with IPF were included in a randomized multicenter crossover study with 8 weeks of standard care and 8 weeks of walk-bike use at home. Ten patients completed both study phases. Study barriers included reluctance to participate and external factors (e.g. weather and road conditions) that hampered adherence. Patients' satisfaction and experience with the walk-bike varied greatly. After training with the walk-bike, health-related QoL (St. George's Respiratory and King's Brief Interstitial Lung Disease questionnaires) demonstrated a tendency towards improvement, exercise capacity did not. A clinically important difference was found between 6-minute walk test with the walk-bike and the standard test; median (range) respectively 602 m (358-684) and 486 m (382-510). Conclusions: Due to practical barriers a larger study with the walk-bike in patients with IPF seems not feasible. Individual patients may benefit from the use of a walk-bike as it improved action radius and showed a tendency towards improvement in QoL. No effect on exercise capacity was observed.  (Sarcoidosis Vasc Diffuse Lung Dis 2020; 37 (2): 192-202) .",2020,A clinically important difference was found between 6-minute walk test with the walk-bike and the standard test; median (range) respectively 602 m (358-684) and 486 m (382-510).,"['Twenty-three patients with IPF', 'patients with idiopathic pulmonary fibrosis', 'COPD patients', 'IPF patients', 'Idiopathic pulmonary fibrosis (IPF']","['homebased walk-bike intervention', 'walk-bike']","['exercise capacity', 'quality of life (QoL) and exercise capacity', 'exercise performance', 'quality of life and exercise capacity']","[{'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1800706', 'cui_str': 'Idiopathic pulmonary fibrosis'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}]","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0005375', 'cui_str': 'Bicycle'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",23.0,0.0227786,A clinically important difference was found between 6-minute walk test with the walk-bike and the standard test; median (range) respectively 602 m (358-684) and 486 m (382-510).,"[{'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'Wapenaar', 'Affiliation': 'Department of Respiratory Medicine, Erasmus University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Bendstrup', 'Affiliation': 'Department of Respiratory Diseases and Allergy, Aarhus University Hospital, Aarhus.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Molina-Molina', 'Affiliation': 'ILD Unit, Hospital de Bellvitge-IDIBELL, University of Barcelona, Spain.'}, {'ForeName': 'Maarten K N', 'Initials': 'MKN', 'LastName': 'Stessel', 'Affiliation': 'Department of Respiratory Diseases, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Jasmina', 'Initials': 'J', 'LastName': 'Huremovic', 'Affiliation': 'Department of Respiratory Diseases, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Eric W', 'Initials': 'EW', 'LastName': 'Bakker', 'Affiliation': 'Division Clinical Methods and Public Health, Academic Medical Center, University of Amsterdam, the Netherlands.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Kardys', 'Affiliation': 'Department of Cardiology, Erasmus University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Joachim G J V', 'Initials': 'JGJV', 'LastName': 'Aerts', 'Affiliation': 'Department of Respiratory Medicine, Erasmus University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Marlies S', 'Initials': 'MS', 'LastName': 'Wijsenbeek', 'Affiliation': 'Department of Respiratory Medicine, Erasmus University Medical Center, Rotterdam, the Netherlands.'}]","Sarcoidosis, vasculitis, and diffuse lung diseases : official journal of WASOG",['10.36141/svdld.v37i2.9433']
2173,33093816,Transcatheter Closure of Patent Ductus Arteriosus under Echocardiography Guidance: A Randomized Controlled Noninferiority Trial.,"Background


Percutaneous occlusion under fluoroscopy guidance has become the preferred method for the treatment of patent ductus arteriosus (PDA). To avoid radiation exposure and contrast agent use, PDA occlusion under transthoracic echocardiography (TTE) guidance was conducted.
Objectives


We assessed the hypothesis that the success rate of percutaneous PDA occlusion under TTE was noninferior to that under fluoroscopy guidance.
Methods


In this single-center trial, 100 patients were randomly assigned in a 1 : 1 ratio to the TTE group ( n  = 50) or to the fluoroscopy group ( n  = 50). The primary endpoint was the success rate of occlusion, with the noninferiority margin set at 8% for the between-group difference in intention-to-treat analysis. Secondary endpoints were hospitalization duration, cost, procedure time, and rate of adverse events including occluder migration, hemolysis, peripheral vascular complications, and residual shunt at 1-month and 12-month follow-up.
Results


Patient, defect, and device characteristics were similarly distributed between groups. The success rate of occlusion was 98% for the TTE group and 100% for the fluoroscopy group (absolute difference: -2%; 95% confidence interval: -5.9% to 1.9%). Cost and procedure duration were significantly lower in the TTE group, without adverse events in either group at a median of 12.0 months (range, 10.0-15.5 months) of follow-up.
Conclusion


Percutaneous PDA occlusion can be performed via TTE guidance safely and effectively, and the success rate of the TTE-guided procedure was noninferior to that under fluoroscopy guidance, with reduced cost and procedure time. The trial is registered with http://www.chictr.org.cn (ChiCTR-ICR-15006334).",2020,"Secondary endpoints were hospitalization duration, cost, procedure time, and rate of adverse events including occluder migration, hemolysis, peripheral vascular complications, and residual shunt at 1-month and 12-month follow-up.
","['Arteriosus under Echocardiography Guidance', 'patent ductus arteriosus (PDA', '100 patients']","['TTE', 'Transcatheter Closure of Patent Ductus', 'PDA occlusion under transthoracic echocardiography (TTE) guidance']","['Cost and procedure duration', 'success rate of occlusion', 'hospitalization duration, cost, procedure time, and rate of adverse events including occluder migration, hemolysis, peripheral vascular complications, and residual shunt at 1-month and 12-month follow-up', 'success rate of occlusion, with the noninferiority margin set']","[{'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C0013274', 'cui_str': 'Patent ductus arteriosus'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C0442343', 'cui_str': 'Transcatheter approach'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0030650', 'cui_str': 'Patents'}, {'cui': 'C0013274', 'cui_str': 'Patent ductus arteriosus'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0237731', 'cui_str': 'Human Migration'}, {'cui': 'C0019054', 'cui_str': 'Haemolysis'}, {'cui': 'C0161817', 'cui_str': 'Peripheral vascular complication'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0542331', 'cui_str': 'Shunt'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}]",100.0,0.171864,"Secondary endpoints were hospitalization duration, cost, procedure time, and rate of adverse events including occluder migration, hemolysis, peripheral vascular complications, and residual shunt at 1-month and 12-month follow-up.
","[{'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'National Center for Cardiovascular Disease, China and Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100037, China.'}, {'ForeName': 'Fengwen', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': 'National Center for Cardiovascular Disease, China and Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100037, China.'}, {'ForeName': 'Wenbin', 'Initials': 'W', 'LastName': 'Ouyang', 'Affiliation': 'National Center for Cardiovascular Disease, China and Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100037, China.'}, {'ForeName': 'Guangzhi', 'Initials': 'G', 'LastName': 'Zhao', 'Affiliation': 'National Center for Cardiovascular Disease, China and Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100037, China.'}, {'ForeName': 'Wenxin', 'Initials': 'W', 'LastName': 'Lu', 'Affiliation': 'National Center for Cardiovascular Disease, China and Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100037, China.'}, {'ForeName': 'Mengxuan', 'Initials': 'M', 'LastName': 'Zou', 'Affiliation': 'National Center for Cardiovascular Disease, China and Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100037, China.'}, {'ForeName': 'Xiangbin', 'Initials': 'X', 'LastName': 'Pan', 'Affiliation': 'National Center for Cardiovascular Disease, China and Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100037, China.'}]",Journal of interventional cardiology,['10.1155/2020/4357017']
2174,33093891,Comparison of two regimens for patients with thyroid-associated ophthalmopathy receiving intravenous methyl prednisolone: A single center prospective randomized trial.,"Intravenous (i.v.) glucocorticoid is recommended for active moderate-to-severe thyroid-associated ophthalmopathy (TAO). However, the details of the treatment schedule are still debatable. The present prospective randomized trial was performed to compare clinical outcomes and serum cytokines between the two regimens. A cohort of 90 patients with active moderate-to-severe TAO was randomized to receive i.v. methyl prednisolone on a weekly protocol or daily scheme. The response rate was evaluated at the 12-week follow-up visit. Serum interleukin (IL)-2, IL-6 and IL-17 levels were measured in 160 patients with TAO, 60 patients with isolated Graves' disease (GD) and 60 normal control (NC) at baseline, as well as patients with active moderate-to-severe TAO at the 12 th  week after treatment. The daily scheme had a higher response rate than the weekly protocol without a significant difference (77.8 vs .  63.6%, P>0.05). No major adverse events were recorded under either regimen. Overall, minor events were more common on the daily scheme (11.36 vs .  4.35%, P<0.05)than on the weekly protocol, whereas the deterioration of eye symptoms (two patients) was only reported on the weekly protocol. At baseline, the IL-17 level in the TAO group was higher than that in the isolated GD and NC groups (P<0.05). In addition, the IL-17 level in the active TAO group was higher than that in the inactive TAO group (P<0.05). Furthermore, the IL-17 level had significantly decreased under the two regimens at the 12-week visit (P<0.05). In conclusion, for patients with active moderate-to-severe TAO, daily i.v. glucocorticoid therapy has a relative higher response rate than the weekly protocol with a few more minor adverse events. These two regimens have their own merits with regard to adverse effects. IL-17 has the potential to be a biomarker for evaluating TAO activity and treatment effects.",2020,"At baseline, the IL-17 level in the TAO group was higher than that in the isolated GD and NC groups (P<0.05).","['90 patients with active moderate-to-severe TAO', 'patients with thyroid-associated ophthalmopathy receiving intravenous', ""160 patients with TAO, 60 patients with isolated Graves' disease (GD) and 60 normal control (NC) at baseline, as well as patients with active moderate-to-severe TAO at the 12 th  week after treatment""]","['glucocorticoid therapy', 'glucocorticoid', 'methyl prednisolone']","['clinical outcomes and serum cytokines', 'IL-17 level', 'Serum interleukin (IL)-2, IL-6 and IL-17 levels', 'deterioration of eye symptoms', 'response rate', 'major adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0040132', 'cui_str': 'Thyroid structure'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0015397', 'cui_str': 'Disorder of eye'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}]","[{'cui': 'C0744425', 'cui_str': 'Glucocorticoid therapy'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0384648', 'cui_str': 'Interleukin 17'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021756', 'cui_str': 'Interleukin-2'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0586406', 'cui_str': 'Eye symptom'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",160.0,0.0377518,"At baseline, the IL-17 level in the TAO group was higher than that in the isolated GD and NC groups (P<0.05).","[{'ForeName': 'Pan-Wei', 'Initials': 'PW', 'LastName': 'Mu', 'Affiliation': 'Department of Endocrinology, The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong 510630, P.R. China.'}, {'ForeName': 'Xi-Xiang', 'Initials': 'XX', 'LastName': 'Tang', 'Affiliation': 'Advanced Medical Center, The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong 510630, P.R. China.'}, {'ForeName': 'Yi-Na', 'Initials': 'YN', 'LastName': 'Wang', 'Affiliation': 'Advanced Medical Center, The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong 510630, P.R. China.'}, {'ForeName': 'Shuo', 'Initials': 'S', 'LastName': 'Lin', 'Affiliation': 'Department of Endocrinology, The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong 510630, P.R. China.'}, {'ForeName': 'Man-Man', 'Initials': 'MM', 'LastName': 'Wang', 'Affiliation': 'Department of Endocrinology, The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong 510630, P.R. China.'}, {'ForeName': 'Qiong-Li', 'Initials': 'QL', 'LastName': 'Yin', 'Affiliation': 'Advanced Medical Center, The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong 510630, P.R. China.'}, {'ForeName': 'Jiong', 'Initials': 'J', 'LastName': 'Shu', 'Affiliation': 'Department of Endocrinology, The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong 510630, P.R. China.'}, {'ForeName': 'Bi-Lian', 'Initials': 'BL', 'LastName': 'Zhu', 'Affiliation': 'Advanced Medical Center, The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong 510630, P.R. China.'}, {'ForeName': 'Jing-Ren', 'Initials': 'JR', 'LastName': 'Li', 'Affiliation': 'Department of Endocrinology, The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong 510630, P.R. China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhou', 'Affiliation': 'Department of Endocrinology, The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong 510630, P.R. China.'}, {'ForeName': 'Long-Yi', 'Initials': 'LY', 'LastName': 'Zeng', 'Affiliation': 'Department of Endocrinology, The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong 510630, P.R. China.'}, {'ForeName': 'Yan-Ming', 'Initials': 'YM', 'LastName': 'Chen', 'Affiliation': 'Department of Endocrinology, The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong 510630, P.R. China.'}]",Experimental and therapeutic medicine,['10.3892/etm.2020.9282']
2175,33094162,A Mental Health-Physical Health-Violence (MPV) Syndemic Factor in Women with Mental Disorders.,"This study extended research on syndemics for women with mental disorders by including self-reported mental and physical health conditions. Syndemics explain complex relationships among co-occurring conditions, and the social circumstances that influence their overlap. Data were from the baseline assessment of a randomized trial of Healthy Home, a nursing home-visit intervention for women with children. 172 adult women who were in mental health or substance use treatment completed measures (in Spanish or English) of anxiety, depression, violence during adulthood, physical health, and cigarette use. Structural Equation Modeling was used to evaluate a single-factor syndemic, and to test the relationships of theoretical predictors of the syndemic: income, number of children, women's abuse during childhood, mental health stigma, social support, and stress. Results supported a single factor syndemic model that explained variation in mental health, physical health, and violence during adulthood. Stress, β = .45,  p  < .001, and stigma, β = .22,  p  = .007, were related to the syndemic factor. There was evidence that self-reported mental and physical health share covariation, which suggested that integrated services for women with mental disorders may have synergistic effects on health. Findings suggest the need to develop and test interventions that address stress and stigma as a means of reducing health disparities for women with mental disorders.",2019,Findings suggest the need to develop and test interventions that address stress and stigma as a means of reducing health disparities for women with mental disorders.,"['women with mental disorders', 'women with children', 'Women with Mental Disorders', 'women with mental disorders by including self-reported mental and physical health conditions', '172 adult women who were in mental health or substance use treatment completed measures (in Spanish or English) of anxiety, depression, violence during adulthood, physical health, and cigarette use']",['nursing home-visit intervention'],"['mental health, physical health, and violence during adulthood']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C4517601', 'cui_str': '172'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0150359', 'cui_str': 'Substance use therapy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0700597', 'cui_str': 'Adulthood'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0020043', 'cui_str': 'Home visit'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0700597', 'cui_str': 'Adulthood'}]",172.0,0.0396416,Findings suggest the need to develop and test interventions that address stress and stigma as a means of reducing health disparities for women with mental disorders.,"[{'ForeName': 'Brian E', 'Initials': 'BE', 'LastName': 'McCabe', 'Affiliation': 'School of Nursing and Health Studies, University of Miami.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Gonzalez-Guarda', 'Affiliation': 'School of Nursing, Duke University.'}, {'ForeName': 'Lila', 'Initials': 'L', 'LastName': 'de Tantillo', 'Affiliation': 'School of Nursing and Health Studies, University of Miami.'}, {'ForeName': 'Victoria B', 'Initials': 'VB', 'LastName': 'Mitrani', 'Affiliation': 'School of Nursing and Health Studies, University of Miami.'}]",Stigma and health,['10.1037/sah0000152']
2176,33094194,Use of a randomized clinical trial design to study cognitive rehabilitation approaches to enhance warfighter performance.,"Within the military, cognitive readiness is essential to ensure the warfighter can return to highly demanding combat training and deployment operations. The warfighter must be able to make split second decisions and adapt to new tools and environments. After a traumatic brain injury, clinicians helping the warfighter must have techniques that address warfighter cognitive readiness. Current rehabilitation for cognitive complaints used in military medicine are modeled after civilian therapies which focus on remediating moderate to severe impairment through building compensatory strategies. This traditional approach to cognitive rehabilitation does not translate well to mild traumatic brain injury (mTBI) where impairments are subtle, nor does it meet the needs of our warfighters in deployed and combat training environments. Challenging our current methods is critical in adapting to the needs of this highly valued population to ensure that our warfighters are able to carry out mission critical decision making. Here we present a review of our best current practices for cognitive rehabilitation, describe the limitations our traditional approaches impose for mTBI in military personnel, and present an alternative treatment called Strategic Memory Advanced Reasoning Training (SMART) that can be adopted through a randomized clinical trial design. We propose directly comparing traditional treatment approaches with a novel cognitive rehabilitation strategy which has been well validated outside of the military setting. Procedures were developed to execute this clinical trial in a way that is most relevant to the study population by establishing ecologically valid outcome metrics.",2020,"This traditional approach to cognitive rehabilitation does not translate well to mild traumatic brain injury (mTBI) where impairments are subtle, nor does it meet the needs of our warfighters in deployed and combat training environments.",[],['Current rehabilitation'],[],[],"[{'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]",[],,0.0390271,"This traditional approach to cognitive rehabilitation does not translate well to mild traumatic brain injury (mTBI) where impairments are subtle, nor does it meet the needs of our warfighters in deployed and combat training environments.","[{'ForeName': 'Ida', 'Initials': 'I', 'LastName': 'Babakhanyan', 'Affiliation': 'Defense and Veterans Brain Injury Center, Silver Spring, MD, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Jensen', 'Affiliation': 'Defense and Veterans Brain Injury Center, Silver Spring, MD, USA.'}, {'ForeName': 'Rosemay A', 'Initials': 'RA', 'LastName': 'Remigio-Baker', 'Affiliation': 'Defense and Veterans Brain Injury Center, Silver Spring, MD, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Sargent', 'Affiliation': 'Naval Hospital Camp Pendleton, Camp Pendleton, CA, USA.'}, {'ForeName': 'Jason M', 'Initials': 'JM', 'LastName': 'Bailie', 'Affiliation': 'Defense and Veterans Brain Injury Center, Silver Spring, MD, USA.'}]",Contemporary clinical trials communications,['10.1016/j.conctc.2020.100660']
2177,33094208,Minimizing Glucose Excursions (GEM) With Continuous Glucose Monitoring in Type 2 Diabetes: A Randomized Clinical Trial.,"This study aimed to compare conventional medication management of type 2 diabetes (T2D) to medication management in conjunction with a lifestyle intervention using continuous glucose monitoring to minimize glucose excursions. Thirty adults (63% female; mean age, 53.3 years) who were diagnosed with T2D for less than 11 years (mean, 5.6 years), had glycated A 1c  (HbA 1c ) ≥ 7.0% (51 mmol/mol) (mean 8.8%, [73 mmol/mol]), and were not using insulin, were randomly assigned in a 1:2 ratio to routine care (RC) or 4 group sessions of glycemic excursion minimization plus real-time CGM (GEM CGM ). Assessments at baseline and 5 months included a physical exam, metabolic and lipid panels, a review of diabetes medications, and psychological questionnaires. For the week following assessments, participants wore a blinded activity monitor and completed 3 days of 24-hour dietary recall. A subgroup also wore a blinded CGM. GEM CGM  participants significantly improved HbA 1c  (from 8.9% to 7.6% [74-60 mmol/mol] compared with 8.8% to 8.7% [73-72 mmol/mol] for RC ( P  = .03). Additionally, GEM CGM  reduced the need for diabetes medication ( P  = .01), reduced carbohydrate consumption ( P  = .009), and improved diabetes knowledge ( P  = .001), quality of life ( P  = .01) and diabetes distress ( P  = .02), and trended to more empowerment ( P  = .05) without increasing dietary fat, lipids, or hypoglycemia. Confirming our prior research, GEM CGM  appears to be a safe, effective lifestyle intervention option for adults with suboptimally controlled T2D who do not take insulin.",2020,"Additionally, GEM CGM  reduced the need for diabetes medication ( P  = .01), reduced carbohydrate consumption ( P  = .009), and improved diabetes knowledge ( P  = .001), quality of life ( P  = .01) and diabetes distress ( P  = .02), and trended to more empowerment ( P  = .05) without increasing dietary fat, lipids, or hypoglycemia.","['adults with suboptimally controlled T2D who do not take insulin', 'Type 2 Diabetes', 'Thirty adults (63% female; mean age, 53.3 years) who were diagnosed with T2D for less than 11 years (mean, 5.6 years), had glycated A 1c  (HbA 1c )\u2005≥\u20057.0% (51 mmol/mol) (mean 8.8%, [73 mmol/mol]), and were not using insulin']","['GEM CGM', 'routine care (RC) or 4 group sessions of glycemic excursion minimization plus real-time CGM (GEM CGM ']","['diabetes knowledge', 'diabetes distress', 'physical exam, metabolic and lipid panels, a review of diabetes medications, and psychological questionnaires', 'HbA 1c', 'need for diabetes medication', 'dietary fat, lipids, or hypoglycemia', 'reduced carbohydrate consumption', 'quality of life', 'Minimizing Glucose Excursions (GEM']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C4517794', 'cui_str': '5.6'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}, {'cui': 'C4517882', 'cui_str': '8.8'}, {'cui': 'C0445107', 'cui_str': 'Not used'}]","[{'cui': 'C0445501', 'cui_str': 'Gem'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0441876', 'cui_str': 'Group 4'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0040223', 'cui_str': 'Time'}]","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0200382', 'cui_str': 'Lipid panel'}, {'cui': 'C0699752', 'cui_str': 'Review of'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0012171', 'cui_str': 'Dietary fat'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0445501', 'cui_str': 'Gem'}]",30.0,0.0359699,"Additionally, GEM CGM  reduced the need for diabetes medication ( P  = .01), reduced carbohydrate consumption ( P  = .009), and improved diabetes knowledge ( P  = .001), quality of life ( P  = .01) and diabetes distress ( P  = .02), and trended to more empowerment ( P  = .05) without increasing dietary fat, lipids, or hypoglycemia.","[{'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Cox', 'Affiliation': 'University of Virginia School of Medicine, Center for Behavioral Medicine Research, Charlottesville, Virginia.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Banton', 'Affiliation': 'University of Virginia School of Medicine, Center for Behavioral Medicine Research, Charlottesville, Virginia.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Moncrief', 'Affiliation': 'University of Virginia School of Medicine, Center for Behavioral Medicine Research, Charlottesville, Virginia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Conaway', 'Affiliation': 'University of Virginia School of Medicine, Public Health Sciences, Charlottesville, VA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Diamond', 'Affiliation': 'University of Virginia School of Medicine, Center for Behavioral Medicine Research, Charlottesville, Virginia.'}, {'ForeName': 'Anthony L', 'Initials': 'AL', 'LastName': 'McCall', 'Affiliation': 'University of Virginia School of Medicine, Endocrinology and Metabolism, Charlottesville, VA.'}]",Journal of the Endocrine Society,['10.1210/jendso/bvaa118']
2178,33094242,Evaluation of START (STrAtegies for RelaTives) adapted for carers of people with Lewy body dementia.,"Family carers of people with Lewy body dementia (LBD) have a particularly high burden of care, as LBD has a faster rate of decline, greater physical dependence and additional neuropsychiatric disturbances compared with other dementias. Despite this, there are no evidence-based support services designed specifically for LBD carers. STrAtegies for RelaTives (START) is an eight-session, individually delivered coping therapy that has been shown in a randomised controlled trial to reduce depression and anxiety symptoms and increase quality of life in carers of people with dementia, with effects lasting several years. We adapted START for LBD, and piloted its use both face-to-face and on the phone with 10 carers to test acceptability and indications of similar effects in this group. Our findings suggest that the therapy was acceptable and feasible using either delivery mode, providing much appreciated and needed strategies, education and support for carers of people with LBD. Trials of effectiveness are now needed.",2020,"Our findings suggest that the therapy was acceptable and feasible using either delivery mode, providing much appreciated and needed strategies, education and support for carers of people with LBD.","['Family carers of people with Lewy body dementia (LBD', 'carers of people with Lewy body dementia']",[],[],"[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0752347', 'cui_str': 'Diffuse Lewy body disease'}]",[],[],,0.0618459,"Our findings suggest that the therapy was acceptable and feasible using either delivery mode, providing much appreciated and needed strategies, education and support for carers of people with LBD.","[{'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Foley', 'Affiliation': 'National Hospital for Neurology and Neurosurgery, London, UK and University College London Institute of Neurology, London, UK.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Dore', 'Affiliation': 'National Hospital for Neurology and Neurosurgery, London, UK.'}, {'ForeName': 'Angeliki', 'Initials': 'A', 'LastName': 'Zarkali', 'Affiliation': 'University College London, London, UK.'}, {'ForeName': 'Gill', 'Initials': 'G', 'LastName': 'Livingston', 'Affiliation': 'University College London, London, UK and Camden and Islington NHS Foundation Trust, London, UK.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Cipolotti', 'Affiliation': 'National Hospital for Neurology and Neurosurgery, London, UK.'}, {'ForeName': 'Catherine J', 'Initials': 'CJ', 'LastName': 'Mummery', 'Affiliation': 'University College London, London, UK.'}, {'ForeName': 'Rimona S', 'Initials': 'RS', 'LastName': 'Weil', 'Affiliation': 'University College London, London, UK.'}]",Future healthcare journal,['10.7861/fhj.2020-0003']
2179,33094385,The sense of smell is not strongly affected by ambient temperature and humidity: a prospective study in a controlled environment.,"INTRODUCTION


The sense of smell is dependent on environmental conditions. In this study, we analysed the effect of temperature and humidity on the ability to smell.
METHODS


Using the controlled setting of a hypobaric climate chamber 50 healthy participants (40 men, 10 women; mean age of 33 years) completed repeated testing in 4 different settings-cold/dry, cold/humid, warm/dry, warm/humid. The temperatures were 20-35 °C, respectively, and the humidity was set at 30-75%. Testing was performed using the ""Sniffin' Sticks"" test battery (odour threshold, discrimination and identification) in a semi-randomised order and in controlled atmospheric pressure conditions.
RESULTS


The analysis showed that neither temperature nor humidity had a significant effect on olfactory test results. This indicates that olfactory functions in healthy, young subjects with an excellent sense of smell are not strongly affected by temporary changes in environmental conditions.",2020,The analysis showed that neither temperature nor humidity had a significant effect on olfactory test results.,"['50 healthy participants (40 men, 10 women; mean age of 33\xa0years) completed']","['repeated testing in 4 different settings-cold/dry, cold/humid, warm/dry, warm/humid', 'hypobaric climate chamber']",[],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0205381', 'cui_str': 'Wet'}, {'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C0008946', 'cui_str': 'Climate'}]",[],50.0,0.0254058,The analysis showed that neither temperature nor humidity had a significant effect on olfactory test results.,"[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Drews', 'Affiliation': 'Smell and Taste Clinic, Department of Otorhinolaryngology, Technische Universität Dresden, Technical University of Dresden Medical School, Fetscherstrasse 74, 01307, Dresden, Germany. tanja.dr@gmail.com.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Nehring', 'Affiliation': 'German Air Force Center for Aerospace Medicine, Steinborner Str. 43, 01936, Königsbrück, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Werner', 'Affiliation': 'German Air Force Center for Aerospace Medicine, Steinborner Str. 43, 01936, Königsbrück, Germany.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Hummel', 'Affiliation': 'Smell and Taste Clinic, Department of Otorhinolaryngology, Technische Universität Dresden, Technical University of Dresden Medical School, Fetscherstrasse 74, 01307, Dresden, Germany.'}]",European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery,['10.1007/s00405-020-06436-3']
2180,33097092,Gemcitabine as adjuvant chemotherapy in patients with high-risk early breast cancer-results from the randomized phase III SUCCESS-A trial.,"BACKGROUND


When chemotherapy is indicated in patients with early breast cancer, regimens that contain anthracyclines and taxanes are established standard treatments. Gemcitabine has shown promising effects on the response and prognosis in patients with metastatic breast cancer. The SUCCESS-A trial (NCT02181101) examined the addition of gemcitabine to a standard chemotherapy regimen in high-risk early breast cancer patients.
METHODS


A total of 3754 patients with at least one of the following characteristics were randomly assigned to one of the two treatment arms: nodal positivity, tumor grade 3, age ≤ 35 years, tumor larger than 2 cm, or negative hormone receptor status. The treatment arms received either three cycles of 5-fluorouracil, epirubicin, and cyclophosphamide, followed by three cycles of docetaxel (FEC → Doc); or three cycles of FEC followed by three cycles of docetaxel and gemcitabine (FEC → Doc/Gem). The primary study aim was disease-free survival (DFS), and the main secondary objectives were overall survival (OS) and safety.
RESULTS


No differences were observed in the 5-year DFS or OS between FEC → Doc and FEC → Doc/Gem. The hazard ratio was 0.93 (95% CI, 0.78 to 1.12; P = 0.47) for DFS and 0.94 (95% CI, 0.74 to 1.19; P = 0.60) for OS. For patients treated with FEC → Doc and FEC → Doc/Gem, the 5-year probabilities of DFS were 86.6% and 87.2%, and the 5-year probabilities of OS were 92.8% and 92.5%, respectively.
CONCLUSION


Adding gemcitabine to a standard chemotherapy does not improve the outcomes in patients with high-risk early breast cancer and should therefore not be included in the adjuvant treatment setting.
TRIAL REGISTRATION


Clinicaltrials.gov NCT02181101 and EU Clinical Trials Register EudraCT 2005-000490-21. Registered September 2005.",2020,"The hazard ratio was 0.93 (95% CI, 0.78 to 1.12; P = 0.47) for DFS and 0.94","['patients with early breast cancer', 'patients with high-risk early breast cancer', 'patients with metastatic breast cancer', 'high-risk early breast cancer patients', '3754 patients with at least one of the following characteristics']","['5-fluorouracil, epirubicin, and cyclophosphamide', 'gemcitabine', 'docetaxel and gemcitabine (FEC\u2009→\u2009Doc/Gem', 'docetaxel (FEC\u2009→\u2009Doc', 'Gemcitabine', 'EudraCT']","['disease-free survival (DFS', '5-year probabilities of DFS', '5-year probabilities of OS', '5-year DFS or OS', 'hazard ratio', 'overall survival (OS) and safety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}]","[{'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0060133', 'cui_str': 'FEC protocol'}, {'cui': 'C0011710', 'cui_str': 'desoxycorticosterone'}, {'cui': 'C0445501', 'cui_str': 'Gem'}]","[{'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",3754.0,0.130094,"The hazard ratio was 0.93 (95% CI, 0.78 to 1.12; P = 0.47) for DFS and 0.94","[{'ForeName': 'Amelie', 'Initials': 'A', 'LastName': 'de Gregorio', 'Affiliation': 'Department of Gynecology and Obstetrics, Ulm University Hospital, Prittwitzstrasse 43, 89075, Ulm, Germany. amelie.degregorio@uniklinik-ulm.de.'}, {'ForeName': 'Lothar', 'Initials': 'L', 'LastName': 'Häberle', 'Affiliation': 'Department of Gynecology and Obstetrics, Erlangen University Hospital, Friedrich-Alexander-University of Erlangen-Nuremberg, Comprehensive Cancer Center EMN, Erlangen, Germany.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Fasching', 'Affiliation': 'Department of Gynecology and Obstetrics, Erlangen University Hospital, Friedrich-Alexander-University of Erlangen-Nuremberg, Comprehensive Cancer Center EMN, Erlangen, Germany.'}, {'ForeName': 'Volkmar', 'Initials': 'V', 'LastName': 'Müller', 'Affiliation': 'Department of Gynecology, University Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Schrader', 'Affiliation': 'Gynecologic-Oncological Practice, Hannover, Germany.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Lorenz', 'Affiliation': 'Gynecologic Practice Dr. Lorenz, N. Hecker, Dr. Kreiss-Sender, Braunschweig, Germany.'}, {'ForeName': 'Helmut', 'Initials': 'H', 'LastName': 'Forstbauer', 'Affiliation': 'Hemato-Oncological Practice Dres Forstbauer and Ziske, Troisdorf, Germany.'}, {'ForeName': 'Thomas W P', 'Initials': 'TWP', 'LastName': 'Friedl', 'Affiliation': 'Department of Gynecology and Obstetrics, Ulm University Hospital, Prittwitzstrasse 43, 89075, Ulm, Germany.'}, {'ForeName': 'Emanuel', 'Initials': 'E', 'LastName': 'Bauer', 'Affiliation': 'Department of Gynecology and Obstetrics, Ulm University Hospital, Prittwitzstrasse 43, 89075, Ulm, Germany.'}, {'ForeName': 'Nikolaus', 'Initials': 'N', 'LastName': 'de Gregorio', 'Affiliation': 'Department of Gynecology and Obstetrics, Ulm University Hospital, Prittwitzstrasse 43, 89075, Ulm, Germany.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Deniz', 'Affiliation': 'Department of Gynecology and Obstetrics, Ulm University Hospital, Prittwitzstrasse 43, 89075, Ulm, Germany.'}, {'ForeName': 'Visnja', 'Initials': 'V', 'LastName': 'Fink', 'Affiliation': 'Department of Gynecology and Obstetrics, Ulm University Hospital, Prittwitzstrasse 43, 89075, Ulm, Germany.'}, {'ForeName': 'Inga', 'Initials': 'I', 'LastName': 'Bekes', 'Affiliation': 'Department of Gynecology and Obstetrics, Ulm University Hospital, Prittwitzstrasse 43, 89075, Ulm, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Andergassen', 'Affiliation': 'Department of Obstetrics and Gynecology, University Hospital, Ludwig-Maximilians-University of Munich, Munich, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Schneeweiss', 'Affiliation': 'National Center for Tumor Diseases, Division of Gynecologic Oncology and German Cancer Research Center, Heidelberg, Germany.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Tesch', 'Affiliation': 'Department of Oncology, Onkologie Bethanien, Frankfurt, Germany.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Mahner', 'Affiliation': 'Department of Obstetrics and Gynecology, University Hospital, Ludwig-Maximilians-University of Munich, Munich, Germany.'}, {'ForeName': 'Sara Y', 'Initials': 'SY', 'LastName': 'Brucker', 'Affiliation': 'Department of Gynecology and Obstetrics, Tübingen University Hospital, Tübingen, Germany.'}, {'ForeName': 'Jens-Uwe', 'Initials': 'JU', 'LastName': 'Blohmer', 'Affiliation': 'Department of Gynecology and Breast Center, Charité University Hospital Campus Charité-Mitte, Berlin, Germany.'}, {'ForeName': 'Tanja N', 'Initials': 'TN', 'LastName': 'Fehm', 'Affiliation': 'Department of Gynecology and Obstetrics, Düsseldorf University Hospital, Heinrich-Heine University, Düsseldorf, Germany.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Heinrich', 'Affiliation': 'Department of Gynecologic Oncology, Schwerpunktpraxis für Gynäkologische Onkologie, Fürstenwalde, Germany.'}, {'ForeName': 'Krisztian', 'Initials': 'K', 'LastName': 'Lato', 'Affiliation': 'Department of Gynecology and Obstetrics, Ulm University Hospital, Prittwitzstrasse 43, 89075, Ulm, Germany.'}, {'ForeName': 'Matthias W', 'Initials': 'MW', 'LastName': 'Beckmann', 'Affiliation': 'Department of Gynecology and Obstetrics, Erlangen University Hospital, Friedrich-Alexander-University of Erlangen-Nuremberg, Comprehensive Cancer Center EMN, Erlangen, Germany.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Rack', 'Affiliation': 'Department of Gynecology and Obstetrics, Ulm University Hospital, Prittwitzstrasse 43, 89075, Ulm, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Janni', 'Affiliation': 'Department of Gynecology and Obstetrics, Ulm University Hospital, Prittwitzstrasse 43, 89075, Ulm, Germany.'}]",Breast cancer research : BCR,['10.1186/s13058-020-01348-w']
2181,33097097,NIATx-TI versus typical product training on e-health technology implementation: a clustered randomized controlled trial study protocol.,"BACKGROUND


Substance use disorders (SUDs) lead to tens-of-thousands of overdose deaths and other forms of preventable deaths in the USA each year. This results in over $500 billion per year in societal and economic costs as well as a considerable amount of grief for loved ones of affected individuals. Despite these health and societal consequences, only a small percentage of people seek treatment for SUDs, and the majority of those that seek help fail to achieve long-term sobriety. E-health applications in healthcare have proven to be effective at sustaining treatment and reaching patients traditional treatment pathways would have missed. However, e-health adoption and sustainment rates in healthcare are poor, especially in the SUD treatment sector. Implementation engineering can address this gap in the e-health field by augmenting existing implementation models, which explain organizational and individual e-health behaviors retrospectively, with prospective resources that can guide implementation.
METHODS


This cluster randomized control trial is designed to test two implementation strategies at adopting an evidence-based mobile e-health technology for SUD treatment. The proposed e-health implementation model is the Network for the Improvement of Addiction Treatment-Technology Implementation (NIATx-TI) Framework. This project, based in Iowa, will compare a control condition (using a typical software product training approach that includes in-person staff training followed by access to on-line support) to software implementation utilizing NIATx-TI, which includes change management training, followed by coaching on how to implement and use the mobile application. While e-health spans many modalities and health disciplines, this project will focus on implementing the Addiction Comprehensive Health Enhancement Support System (A-CHESS), an evidence-based SUD treatment recovery app framework. This trial will be conducted in Iowa at 46 organizational sites within 12 SUD treatment agencies. The control arm consists of 23 individual treatment sites based at five organizations, and the intervention arm consists of 23 individual SUD treatment sites based at seven organizations DISCUSSION: This study addresses an issue of substantial public health significance: enhancing the uptake of the growing inventory of patient-centered evidence-based addiction treatment e-health technologies.
TRIAL REGISTRATION


ClinicalTrials.gov , NCT03954184 . Posted 17 May 2019.",2020,This cluster randomized control trial is designed to test two implementation strategies at adopting an evidence-based mobile e-health technology for SUD treatment.,['Iowa at 46 organizational sites within 12 SUD treatment agencies'],['NIATx-TI versus typical product training'],[],"[{'cui': 'C0022037', 'cui_str': 'Iowa'}, {'cui': 'C0029246', 'cui_str': 'Organizations'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}]",[],,0.0436354,This cluster randomized control trial is designed to test two implementation strategies at adopting an evidence-based mobile e-health technology for SUD treatment.,"[{'ForeName': 'Veronica M', 'Initials': 'VM', 'LastName': 'White', 'Affiliation': 'Department of Industrial and Systems Engineering, University of Wisconsin-Madison, 1513 University Ave, Madison, WI, 53706, USA. vmwhite@wisc.edu.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Molfenter', 'Affiliation': 'Department of Industrial and Systems Engineering, University of Wisconsin-Madison, 1513 University Ave, Madison, WI, 53706, USA.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Gustafson', 'Affiliation': 'Department of Industrial and Systems Engineering, University of Wisconsin-Madison, 1513 University Ave, Madison, WI, 53706, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Horst', 'Affiliation': 'Department of Industrial and Systems Engineering, University of Wisconsin-Madison, 1513 University Ave, Madison, WI, 53706, USA.'}, {'ForeName': 'Rachelle', 'Initials': 'R', 'LastName': 'Greller', 'Affiliation': 'Department of Industrial and Systems Engineering, University of Wisconsin-Madison, 1513 University Ave, Madison, WI, 53706, USA.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Gustafson', 'Affiliation': 'Department of Industrial and Systems Engineering, University of Wisconsin-Madison, 1513 University Ave, Madison, WI, 53706, USA.'}, {'ForeName': 'Jee-Seon', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': 'Department of Educational Psychology, University of Wisconsin-Madison, Educational Sciences, 1025 West Johnson St, Madison, WI, 53706-1706, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Preuss', 'Affiliation': 'Division of Behavioral Health, Iowa Department of Public Health, Lucas State Office Building, 321 E. 12th Street, Des Moines, IA, 50319-0075, USA.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Cody', 'Affiliation': 'Department of Industrial and Systems Engineering, University of Wisconsin-Madison, 1513 University Ave, Madison, WI, 53706, USA.'}, {'ForeName': 'Praan', 'Initials': 'P', 'LastName': 'Pisitthakarm', 'Affiliation': 'Department of Industrial and Systems Engineering, University of Wisconsin-Madison, 1513 University Ave, Madison, WI, 53706, USA.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Toy', 'Affiliation': 'Department of Industrial and Systems Engineering, University of Wisconsin-Madison, 1513 University Ave, Madison, WI, 53706, USA.'}]",Implementation science : IS,['10.1186/s13012-020-01053-4']
2182,33097174,"Reply to Comment on: ""Long-term Results of Trimethoprim Sulfamethoxazole Versus Placebo to Reduce the Risk of Recurrent Toxoplasma gondii Retinochoroiditis"".",,2020,,[],['Trimethoprim Sulfamethoxazole Versus Placebo'],['Risk of Recurrent Toxoplasma gondii Retinochoroiditis'],[],"[{'cui': 'C0041044', 'cui_str': 'sulfamethoxazole and trimethoprim'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0040557', 'cui_str': 'Toxoplasma gondii'}, {'cui': 'C0008513', 'cui_str': 'Chorioretinitis'}]",,0.0343107,,"[{'ForeName': 'João Paulo', 'Initials': 'JP', 'LastName': 'Fernandes Felix', 'Affiliation': 'Campinas, Brazil.'}, {'ForeName': 'Rodrigo Pessoa', 'Initials': 'RP', 'LastName': 'Cavalcanti Lira', 'Affiliation': 'Campinas, Recife, Brazil.'}, {'ForeName': 'Alex Treiger', 'Initials': 'AT', 'LastName': 'Grupenmacher', 'Affiliation': 'Campinas, Brazil.'}, {'ForeName': 'Hermano Lucio Gomes', 'Initials': 'HLG', 'LastName': 'de Assis Filho', 'Affiliation': 'Campinas, Brazil.'}, {'ForeName': 'Alexandre Brito', 'Initials': 'AB', 'LastName': 'Cosimo', 'Affiliation': 'Campinas, Brazil.'}, {'ForeName': 'Mauricio Abujamra', 'Initials': 'MA', 'LastName': 'Nascimento', 'Affiliation': 'Campinas, Brazil.'}, {'ForeName': 'Carlos Eduardo', 'Initials': 'CE', 'LastName': 'Leite Arieta', 'Affiliation': 'Campinas, Brazil.'}]",American journal of ophthalmology,['10.1016/j.ajo.2020.08.008']
2183,33097176,"Comment on: ""Long-term Results of Trimethoprim Sulfamethoxazole Versus Placebo to Reduce the Risk of Recurrent Toxoplasma gondii Retinochoroiditis"".",,2020,,[],['Trimethoprim Sulfamethoxazole Versus Placebo'],['Risk of Recurrent Toxoplasma gondii Retinochoroiditis'],[],"[{'cui': 'C0041044', 'cui_str': 'sulfamethoxazole and trimethoprim'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0040557', 'cui_str': 'Toxoplasma gondii'}, {'cui': 'C0008513', 'cui_str': 'Chorioretinitis'}]",,0.047294,,"[{'ForeName': 'Devesh', 'Initials': 'D', 'LastName': 'Kumawat', 'Affiliation': 'Rishikesh, India.'}, {'ForeName': 'Ramanuj', 'Initials': 'R', 'LastName': 'Samanta', 'Affiliation': 'Rishikesh, India.'}, {'ForeName': 'Pranita', 'Initials': 'P', 'LastName': 'Sahay', 'Affiliation': 'New Delhi, India.'}]",American journal of ophthalmology,['10.1016/j.ajo.2020.07.054']
2184,33097178,Comment on: Posterior Capsule Opacification With Two Hydrophobic Acrylic Intraocular Lenses: 3-Year Results of a Randomized Trial.,,2020,,[],['Posterior Capsule Opacification With Two Hydrophobic Acrylic Intraocular Lenses'],[],[],"[{'cui': 'C1444680', 'cui_str': 'Posterior capsule opacification'}, {'cui': 'C0598629', 'cui_str': 'Hydrophobicity'}, {'cui': 'C0440181', 'cui_str': 'Acrylic dental material'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}]",[],,0.0696872,,"[{'ForeName': 'Raimo', 'Initials': 'R', 'LastName': 'Tuuminen', 'Affiliation': 'Helsinki, Finland; Kotka, Finland.'}, {'ForeName': 'Jose I', 'Initials': 'JI', 'LastName': 'Belda', 'Affiliation': 'Alicante, Spain.'}]",American journal of ophthalmology,['10.1016/j.ajo.2020.08.017']
2185,33097351,Comparing Diazepam Plus Fentanyl With Midazolam Plus Fentanyl in the Moderate Procedural Sedation of Anterior Shoulder Dislocations: A Randomized Clinical Trial.,"BACKGROUND


The reduction of shoulder dislocation requires adequate procedural sedation and analgesia. The mixture of midazolam and fentanyl is reported in the literature, but long-acting benzodiazepines in conjunction with fentanyl are lacking.
STUDY OBJECTIVE


Our aim was to compar e IV diazepam with IV midazolam in moderate procedural sedation (based on the classification of the American Society of Anesthesiologists) for the reduction of shoulder dislocation.
METHODS


This was a randomized controlled clinical trial conducted from April 2019 to December 2019 in the emergency department of a university-affiliated hospital in Tehran, Iran. Participants were adult patients (aged 18-65 years) with anterior shoulder dislocation. Group A (n = 42) received diazepam 0.1 mg/kg plus fentanyl 1 μg/kg IV and group B received midazolam 0.1 mg/kg plus fentanyl 1 μg g/kg IV. Main outcomes measured were onset of muscle relaxation, time taken to reduction, total procedure time, number of the reduction attempts, patient recovery time, the occurrence of the adverse effects, amount of the pain reported by the patients using visual analog scale, and patients and physicians overall satisfaction with the procedure using a Likert scale question.
RESULTS


Eighty-one patients were included. The mean ± standard deviation time of the onset of the muscle relaxation and time taken to reduction was shorter in the diazepam plus fentanyl group (p = 0.016 and p = 0.001, respectively). Adverse effects and pain relief were not statistically different between the two groups. Patient recovery time and total procedure time was shorter in the midazolam plus fentanyl group (p = 0.008 and p = 0.02, respectively). The overall satisfaction of patients and physicians was higher in the diazepam plus fentanyl group.
CONCLUSIONS


As compared with midazolam plus fentanyl, diazepam plus fentanyl was superior in terms of the onset of the muscle relaxation, patient and physician satisfaction, and time taken to reduction.",2020,Patient recovery time and total procedure time was shorter in the midazolam plus fentanyl group (,"['Anterior Shoulder Dislocations', 'Participants were adult patients (aged 18-65\xa0years) with anterior shoulder dislocation', 'from April 2019 to December 2019 in the emergency department of a university-affiliated hospital in Tehran, Iran', 'Eighty-one patients were included']","['diazepam 0.1\xa0mg/kg plus fentanyl', 'diazepam', 'midazolam and fentanyl', 'diazepam with IV midazolam', 'Diazepam Plus Fentanyl', 'Midazolam Plus Fentanyl', 'midazolam plus fentanyl, diazepam plus fentanyl', 'midazolam 0.1\xa0mg/kg plus fentanyl 1', 'midazolam plus fentanyl']","['overall satisfaction', 'mean\xa0±\xa0standard deviation time of the onset of the muscle relaxation and time taken to reduction', 'onset of muscle relaxation, time taken to reduction, total procedure time, number of the reduction attempts, patient recovery time, the occurrence of the adverse effects, amount of the pain reported by the patients using visual analog scale, and patients and physicians overall satisfaction with the procedure using a Likert scale question', 'Adverse effects and pain relief', 'Patient recovery time and total procedure time']","[{'cui': 'C0347738', 'cui_str': 'Anterior dislocation of shoulder joint'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C4517884', 'cui_str': '81'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0012010', 'cui_str': 'Diazepam'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0026836', 'cui_str': 'Muscle relaxation'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0451267', 'cui_str': 'Likert scale'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}]",81.0,0.132486,Patient recovery time and total procedure time was shorter in the midazolam plus fentanyl group (,"[{'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Afzalimoghaddam', 'Affiliation': 'Department of Emergency Medicine, Prehospital Emergency Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Maryam Feyiz', 'Initials': 'MF', 'LastName': 'Khademi', 'Affiliation': 'Department of Emergency Medicine, Prehospital Emergency Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hadi', 'Initials': 'H', 'LastName': 'Mirfazaelian', 'Affiliation': 'Department of Emergency Medicine, Prehospital Emergency Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Pooya', 'Initials': 'P', 'LastName': 'Payandemehr', 'Affiliation': 'Department of Emergency Medicine, Prehospital Emergency Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ehsan', 'Initials': 'E', 'LastName': 'Karimialavijeh', 'Affiliation': 'Department of Emergency Medicine, Prehospital Emergency Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Jalali', 'Affiliation': 'Department of Emergency Medicine, Prehospital Emergency Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}]",The Journal of emergency medicine,['10.1016/j.jemermed.2020.09.030']
2186,33097364,Anti-inflammatory and antimicrobial effects of Zingiber officinale mouthwash on patients with fixed orthodontic appliances.,"INTRODUCTION


This study aimed to assess the anti-inflammatory and antimicrobial effects of mouthwashes with 0.12% chlorhexidine (CLX) and 0.5% Zingiber officinale essential oil (ZOEO).
METHODS


The gas chromatography-mass spectrometry of ZOEO was developed, and the mouthwash was prepared. Thirty-one adult subjects of both sexes with fixed orthodontic appliances were selected. For 7 days, the mouthwashes with CLX, ZOEO, and flavored sterile water placebo were used randomly, with a 15-day interval between each solution. Saliva was collected before the first mouthwash, 1 minute and 15 minutes after it, and on the seventh day. The patients were subjected to clinical examinations of the bonded bracket index proposed by Ciancio, bleeding on probing, and sensory analysis (flavor). Generalized linear models were used to assess in vitro cell viability. The GENMOD procedure was used to assess the changes of bleeding on probing, and Friedman and Wilcoxon tests were used for data on colony-forming units per milliliter (CFU/mL), bonded bracket index, and flavor, at the 5% significance level.
RESULTS


In the microbiologic analysis, the ZOEO mouthwash presented antimicrobial effectiveness for Streptococcus mutans as well as the CLX mouthwash, but it did not show the same substantivity. The ZOEO was efficient in controlling dental biofilm and reducing gingival bleeding. The sensory analyses showed that the flavor for ZOEO and CLX solutions presented low acceptability.
CONCLUSIONS


The ZOEO mouthwash has an anti-inflammatory property with an effect on reducing gingival bleeding. However, it requires adjustments to the formulation to improve flavor quality.",2020,"In the microbiologic analysis, the ZOEO mouthwash presented antimicrobial effectiveness for Streptococcus mutans as well as the CLX mouthwash, but it did not show the same substantivity.","['Thirty-one adult subjects of both sexes with fixed orthodontic appliances', 'patients with fixed orthodontic appliances']","['mouthwashes with\xa00.12% chlorhexidine (CLX) and 0.5% Zingiber officinale essential oil (ZOEO', 'mouthwashes with CLX, ZOEO, and flavored sterile water placebo']","['gingival bleeding', 'flavor quality', 'changes of bleeding on probing, and Friedman and Wilcoxon tests', 'antimicrobial effectiveness']","[{'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0441421', 'cui_str': 'Fixed orthodontic appliance'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0026647', 'cui_str': 'Oromucosal solution for gargle'}, {'cui': 'C4517426', 'cui_str': '0.12'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0162751', 'cui_str': 'Ginger'}, {'cui': 'C0028910', 'cui_str': 'Volatile oil'}, {'cui': 'C0682897', 'cui_str': 'Flavor Enhancers'}, {'cui': 'C0359299', 'cui_str': 'sterile water'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0017565', 'cui_str': 'Bleeding gums'}, {'cui': 'C0682897', 'cui_str': 'Flavor Enhancers'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",31.0,0.0411974,"In the microbiologic analysis, the ZOEO mouthwash presented antimicrobial effectiveness for Streptococcus mutans as well as the CLX mouthwash, but it did not show the same substantivity.","[{'ForeName': 'Tieli Roxo', 'Initials': 'TR', 'LastName': 'Bauer Faria', 'Affiliation': 'Department of Orthodontics, Fundação Hermínio Ometto, Araras, São Paulo, Brazil.'}, {'ForeName': 'Vivian Fernandes', 'Initials': 'VF', 'LastName': 'Furletti-Goes', 'Affiliation': 'Department of Orthodontics, Fundação Hermínio Ometto, Araras, São Paulo, Brazil.'}, {'ForeName': 'Cristina Maria', 'Initials': 'CM', 'LastName': 'Franzini', 'Affiliation': 'Department of Orthodontics, Fundação Hermínio Ometto, Araras, São Paulo, Brazil.'}, {'ForeName': 'Andrea Aparecida', 'Initials': 'AA', 'LastName': 'de Aro', 'Affiliation': 'Department of Biomedical Sciences School, Fundação Hermínio Ometto, Araras, São Paulo, Brazil.'}, {'ForeName': 'Thiago Antônio Moretti', 'Initials': 'TAM', 'LastName': 'de Andrade', 'Affiliation': 'Department of Biomedical Sciences School, Fundação Hermínio Ometto, Araras, São Paulo, Brazil.'}, {'ForeName': 'Adilson', 'Initials': 'A', 'LastName': 'Sartoratto', 'Affiliation': 'Division of Organic and Pharmaceutical Chemistry, Pluridisciplinary Center for Chemical, Biological and Agricultural Research, University of Campinas, Paulinia, São Paulo, Brazil.'}, {'ForeName': 'Carolina Carmo', 'Initials': 'CC', 'LastName': 'de Menezes', 'Affiliation': 'Department of Orthodontics, Fundação Hermínio Ometto, Araras, São Paulo, Brazil. Electronic address: carol.menezes.odonto@gmail.com.'}]","American journal of orthodontics and dentofacial orthopedics : official publication of the American Association of Orthodontists, its constituent societies, and the American Board of Orthodontics",['10.1016/j.ajodo.2019.10.025']
2187,33097936,Time Course and Sex Effects of α-Linolenic Acid-Rich and DHA-Rich Supplements on Human Plasma Oxylipins: A Randomized Double-Blind Crossover Trial.,"BACKGROUND


Differences in health effects of dietary α-linolenic acid (ALA) and DHA are mediated at least in part by differences in their effects on oxylipins.
OBJECTIVES


Time course and sex differences of plasma oxylipins in response to ALA- compared with DHA-rich supplements were examined.
METHODS


Healthy men and women, aged 19-34 y and BMI 18-28 kg/m2, were provided with capsules containing ∼4 g/d of ALA or DHA in a randomized double-blind crossover study with >6-wk wash-in and wash-out phases. Plasma PUFA and oxylipin (primary outcome) concentrations at days 0, 1, 3, 7, 14, and 28 of supplementation were analyzed by GC and HPLC-MS/MS, respectively. Sex differences, supplementation and time effects, and days to plateau were analyzed.
RESULTS


ALA supplementation doubled ALA concentrations, but had no effects on ALA oxylipins after 28 d, whereas DHA supplementation tripled both DHA and its oxylipins. Increases in DHA oxylipins were detected as early as day 1, and a plateau was reached by days 5-7 for 11 of 12 individual DHA oxylipins and for total DHA oxylipins. Nine individual DHA oxylipins reached a plateau in females with DHA supplementation, compared with only 4 in males. A similar time course and sex difference pattern occurred with EPA and its oxylipins with DHA supplementation. DHA compared with ALA supplementation also resulted in higher concentrations of 4 individual arachidonic acids, 1 linoleic acid, and 1 dihomo-γ-linolenic acid oxylipin, despite not increasing the concentrations of these fatty acids, further demonstrating that oxylipins do not always reflect their precursor PUFA.
CONCLUSIONS


DHA compared with a similar dose of ALA has greater effects on both n-3 and n-6 oxylipins in young, healthy adults, with differences in response to DHA supplementation occurring earlier and being greater in females. These findings can help explain differences in dietary effects of ALA and DHA.This study was registered at clinicaltrials.gov as NCT02317588.",2020,"RESULTS


ALA supplementation doubled ALA concentrations, but had no effects on ALA oxylipins after 28 d, whereas DHA supplementation tripled both DHA and its oxylipins.","['Healthy men and women, aged 19-34 y and BMI 18-28 kg/m2', 'young, healthy adults', 'Human Plasma Oxylipins']","['α-Linolenic Acid-Rich and DHA-Rich Supplements', 'ALA', 'capsules containing ∼4\xa0g/d of ALA or DHA', 'ALA supplementation', 'dietary α-linolenic acid (ALA']","['DHA oxylipins', 'Plasma PUFA and oxylipin (primary outcome) concentrations', 'ALA oxylipins', 'ALA concentrations']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C1956100', 'cui_str': 'Oxylipins'}]","[{'cui': 'C0051405', 'cui_str': 'alpha-Linolenic Acid'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0142831', 'cui_str': 'sodium dehydroacetate'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0001898', 'cui_str': 'Alanine'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0439417', 'cui_str': 'g/24h'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0142831', 'cui_str': 'sodium dehydroacetate'}, {'cui': 'C1956100', 'cui_str': 'Oxylipins'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0032615', 'cui_str': 'Polyunsaturated fatty acid'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0001898', 'cui_str': 'Alanine'}]",,0.349017,"RESULTS


ALA supplementation doubled ALA concentrations, but had no effects on ALA oxylipins after 28 d, whereas DHA supplementation tripled both DHA and its oxylipins.","[{'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Gabbs', 'Affiliation': 'Department of Food and Human Nutritional Sciences, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Zahradka', 'Affiliation': 'Department of Food and Human Nutritional Sciences, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Carla G', 'Initials': 'CG', 'LastName': 'Taylor', 'Affiliation': 'Department of Food and Human Nutritional Sciences, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Harold M', 'Initials': 'HM', 'LastName': 'Aukema', 'Affiliation': 'Department of Food and Human Nutritional Sciences, University of Manitoba, Winnipeg, Manitoba, Canada.'}]",The Journal of nutrition,['10.1093/jn/nxaa294']
2188,33097941,Quantitative and semi-quantitative assessment of synovitis on MRI and the relationship with symptoms in symptomatic knee osteoarthritis.,"OBJECTIVES


Synovitis in symptomatic knee OA (KOA) is common and is associated with joint symptoms. Optimal synovial measurement on MRI is, however, unclear. Our aims were to examine the relationship between MRI measures of synovitis and knee symptoms in symptomatic KOA.
METHODS


Data from a randomized, multicentre, placebo-controlled trial (UK-VIDEO) of vitamin-D therapy in symptomatic KOA were utilized. Participants reported knee symptoms using WOMAC at baseline and annually. On contrast-enhanced (CE) MRI, synovial thickness was measured using established, semi-quantitative methods whilst synovial tissue volume (STV) was assessed as absolute STV (aSTV) and relative to the width of femoral condyle (rSTV). STV of the infrapatellar region was also assessed. Associations between synovial measures and symptoms were analysed using multiple linear regression modelling.
RESULTS


No linear association was observed between knee symptoms and synovitis thickness scores. Whole-joint aSTV (0.88, 95% CI: 0.17, 1.59) and infrapatellar aSTV (5.96, 95% CI: 1.22, 10.7) were positively associated with knee pain. Whole-joint rSTV had a stronger association with pain (7.96, 95% CI: 2.60, 13.33) and total scores (5.63, 95% CI: 0.32, 10.94). Even stronger associations were found for infrapatellar rSTV with pain (55.47, 95% CI: 19.99, 90.96), function (38.59, 95% CI: 2.1, 75.07) and total scores (41.64, 95% CI: 6.56, 76.72).
CONCLUSIONS


Whole-joint and site-specific infrapatellar STV measures on CE-MRI were associated with knee pain, respectively. Volumes relative to the size of the femoral condyle may be promising outcome measures in KOA trials.",2020,"Whole-joint and site-specific infrapatellar STV measures on CE-MRI were associated with knee pain, respectively.","['symptomatic knee osteoarthritis', 'symptomatic knee OA (KOA']","['vitamin-D therapy', 'placebo']","['contrast-enhanced (CE) MRI, synovial thickness', 'infrapatellar aSTV', 'infrapatellar rSTV with pain', 'total scores', 'knee symptoms using WOMAC', 'knee pain', 'knee symptoms and synovitis thickness scores', 'absolute STV (aSTV) and relative to the width of femoral condyle (rSTV', 'pain']","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0164662', 'cui_str': 'Stavudine'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0039103', 'cui_str': 'Synovitis'}, {'cui': 'C0039099', 'cui_str': 'Synovial membrane'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0582800', 'cui_str': 'Condyle of femur'}]",,0.175211,"Whole-joint and site-specific infrapatellar STV measures on CE-MRI were associated with knee pain, respectively.","[{'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Perry', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Research Centre.'}, {'ForeName': 'Xiaotian', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Research Centre.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'van Santen', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Research Centre.'}, {'ForeName': 'Nigel K', 'Initials': 'NK', 'LastName': 'Arden', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Research Centre.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Kluzek', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Research Centre.'}]","Rheumatology (Oxford, England)",['10.1093/rheumatology/keaa619']
2189,33094465,"Comparison of the effectiveness of pilates exercises, aerobic exercises, and pilates with aerobic exercises in patients with rheumatoid arthritis.","BACKGROUND


Rheumatoid arthritis (RA) is a rheumatic disease characterized by erosive synovitis and polyarthritis. Exercise is known to improve many symptoms in RA patients.
AIM


This study was designed to compare the effects of pilates exercises, aerobic exercises, and combined training including pilates with aerobic exercises on fatigue, depression, aerobic capacity, pain, sleep quality, and quality of life.
METHODS


Thirty voluntary RA patients were included in this study. Patients were divided into three groups equally, and treatment was applied to each group for 8 weeks. Pilates exercises were practiced to the first group, aerobic exercises were practiced to the second group, and combined training was performed to the third group. Fatigue, depression, aerobic capacity, pain, sleep quality, and quality of life were evaluated using Fatigue Severity Scale (FSS), Beck Depression Inventory (BDI), 6-minute walk test (6MWT), McGill Pain Questionnaire- Short Form (MPQ-SF), Pittsburg Sleep Quality Index (PSQI), and Rheumatoid Arthritis Quality of Life (RAQoL), respectively.
RESULTS


The results of the present study showed significant improvements for the first group on fatigue, depression, aerobic capacity, and quality of life (p < 0.05). Improvements in all parameters except for pain were obtained for the second and third groups (p < 0.05). In addition, there was no statistically significant difference among the treatment groups in assessments (p > 0.05).
CONCLUSION


Pilates exercises may have similar effects to aerobic exercises in patients with RA. Addition of clinical pilates exercises to the routine treatment of RA may enhance the success of rehabilitation. Trial registration NCT03836820.",2020,"The results of the present study showed significant improvements for the first group on fatigue, depression, aerobic capacity, and quality of life (p < 0.05).","['RA patients', 'Thirty voluntary RA patients', 'patients with rheumatoid arthritis', 'patients with RA']","['aerobic exercises were practiced to the second group, and combined training', 'pilates exercises, aerobic exercises, and combined training including pilates with aerobic exercises', 'pilates exercises, aerobic exercises, and pilates with aerobic exercises']","['Fatigue Severity Scale (FSS), Beck Depression Inventory (BDI), 6-minute walk test (6MWT), McGill Pain Questionnaire- Short Form (MPQ-SF), Pittsburg Sleep Quality Index (PSQI), and Rheumatoid Arthritis Quality of Life (RAQoL), respectively', 'Fatigue, depression, aerobic capacity, pain, sleep quality, and quality of life', 'fatigue, depression, aerobic capacity, and quality of life', 'fatigue, depression, aerobic capacity, pain, sleep quality, and quality of life', 'pain']","[{'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C0024985', 'cui_str': 'McGill pain chart questionnaire'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",30.0,0.0192653,"The results of the present study showed significant improvements for the first group on fatigue, depression, aerobic capacity, and quality of life (p < 0.05).","[{'ForeName': 'Songül Bağlan', 'Initials': 'SB', 'LastName': 'Yentür', 'Affiliation': 'Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Firat University, Elazig, Turkey. songulbaglan23@hotmail.com.'}, {'ForeName': 'Nuh', 'Initials': 'N', 'LastName': 'Ataş', 'Affiliation': 'Faculty of Medicine, Division of Rheumatology, Gazi University, Ankara, Turkey.'}, {'ForeName': 'Mehmet Akif', 'Initials': 'MA', 'LastName': 'Öztürk', 'Affiliation': 'Faculty of Medicine, Division of Rheumatology, Gazi University, Ankara, Turkey.'}, {'ForeName': 'Deran', 'Initials': 'D', 'LastName': 'Oskay', 'Affiliation': 'Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Gazi University, Ankara, Turkey.'}]",Irish journal of medical science,['10.1007/s11845-020-02412-2']
2190,33094466,Early use of high-dose vitamin C is beneficial in treatment of sepsis.,"PURPOSE


Vitamin C has shown benefits in patients with sepsis in addition to standard therapy recently. However, further evidence is required to verify the efficacy of vitamin C in clinical practice. This study aimed to investigate the effect of adjunctive intravenous high-dose vitamin C treatment on hospital mortality in patients with sepsis.
METHODS


One hundred seventeen patients with sepsis in our department from June 2017 to May 2019 were randomly divided into two groups: the control group (56 cases) and the vitamin C group (61 cases). The control group was treated by the routine and basic therapy with intravenous drip of 5% dextrose and placebo (100 ml/time, 2 times/day), while the vitamin C group was administered intravenously by 3.0 g vitamin C dissolved into 5% dextrose (100 ml/time, 2 times/day) based on the control group. The mortality and efficacy were statistically analyzed and compared between the two groups.
RESULTS


The 28-day mortality differed significantly between the control group and the vitamin C group (42.97% vs. 27.93%) (p < 0.05). The changes in the sepsis-related organ failure assessment (ΔSOFA) scores at 72 h after ICU admission (4.2 vs. 2.1), the application time of vasoactive drugs (25.6 vs. 43.8), and the procalcitonin clearance (79.6% vs. 61.3%) differed significantly between groups (p < 0.05).
CONCLUSION


The early treatment of sepsis with intravenous high-dose vitamin C in combination with standard therapy showed a beneficial effect on sepsis, in terms of the reduced 28-day mortality, the decreased SOFA score, and the increased clearance rate of procalcitonin.",2020,The 28-day mortality differed significantly between the control group and the vitamin C group (42.97% vs. 27.93%) (p < 0.05).,"['One hundred seventeen patients with sepsis in our department from June 2017 to May 2019', 'patients with sepsis', 'patients with sepsis in addition to standard therapy recently']","['intravenous high-dose vitamin C', 'Vitamin C', 'adjunctive intravenous high-dose vitamin C treatment', 'vitamin C group was administered intravenously by 3.0\xa0g vitamin C dissolved into 5% dextrose', 'vitamin C', 'routine and basic therapy with intravenous drip of 5% dextrose and placebo']","['28-day mortality, the decreased SOFA score', 'application time of vasoactive drugs', 'sepsis-related organ failure assessment (ΔSOFA) scores', 'hospital mortality', '28-day mortality', 'mortality and efficacy', 'procalcitonin clearance', 'clearance rate of procalcitonin']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0332185', 'cui_str': 'Recent'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C1549535', 'cui_str': 'Dissolve'}, {'cui': 'C0985452', 'cui_str': 'Glucose 50 MG/ML'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1621368', 'cui_str': 'Drip Infusions'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0349410', 'cui_str': 'Single organ dysfunction'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0072027', 'cui_str': 'Procalcitonin'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0025515', 'cui_str': 'Metabolic clearance rate'}]",117.0,0.0707836,The 28-day mortality differed significantly between the control group and the vitamin C group (42.97% vs. 27.93%) (p < 0.05).,"[{'ForeName': 'Shi-Jin', 'Initials': 'SJ', 'LastName': 'Lv', 'Affiliation': ""Department of Emergency, Hangzhou Normal University Affiliated Hospital, Wenzhou Road 126, Hangzhou, 310015, Zhejiang, People's Republic of China.""}, {'ForeName': 'Guo-Hu', 'Initials': 'GH', 'LastName': 'Zhang', 'Affiliation': ""Department of Emergency, Hangzhou Normal University Affiliated Hospital, Wenzhou Road 126, Hangzhou, 310015, Zhejiang, People's Republic of China. zhguohuhz2020@sina.com.""}, {'ForeName': 'Jin-Ming', 'Initials': 'JM', 'LastName': 'Xia', 'Affiliation': ""Department of Emergency, Hangzhou Normal University Affiliated Hospital, Wenzhou Road 126, Hangzhou, 310015, Zhejiang, People's Republic of China.""}, {'ForeName': 'Huan', 'Initials': 'H', 'LastName': 'Yu', 'Affiliation': ""Department of Emergency, Hangzhou Normal University Affiliated Hospital, Wenzhou Road 126, Hangzhou, 310015, Zhejiang, People's Republic of China.""}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Zhao', 'Affiliation': ""Department of Emergency, Hangzhou Normal University Affiliated Hospital, Wenzhou Road 126, Hangzhou, 310015, Zhejiang, People's Republic of China.""}]",Irish journal of medical science,['10.1007/s11845-020-02394-1']
2191,33094550,"Efficacy and safety of controlled-release dinoprostone vaginal delivery system (PROPESS) in Japanese pregnant women requiring cervical ripening: Results from a multicenter, randomized, double-blind, placebo-controlled phase III study.","AIM


To evaluate the efficacy and safety of dinoprostone vaginal insert (PROPESS) in pregnant post-term Japanese women requiring cervical ripening.
METHODS


This randomized, double-blind, placebo-controlled study included 114 pregnant Japanese women at term (41 weeks of gestation) requiring cervical ripening (baseline Bishop score (BS) ≤ 4). The primary end-point was the proportion of subjects with successful cervical ripening defined as BS ≥ 7 or vaginal delivery in 12 h. The secondary end-points were changes in BS, proportion of women with vaginal delivery, proportion of women receiving mechanical cervical ripening procedure and use of oxytocic drugs.
RESULTS


PROPESS administration for a maximum of 12 h showed significantly higher successful cervical ripening rate (47.4% vs 14.3%, respectively; treatment contrast [TC]: 33.1%; P = 0.0002). The median time from administration to vaginal delivery was significantly shorter in the PROPESS group than in the placebo group (26.18 h vs 33.02 h; OR 2.51; 95% CI [1.60-3.92]; P < 0.0001). In the PROPESS group, the dosage of uterotonic drugs, such as oxytocin, decreased, and the number of patients who used these drugs also decreased.
CONCLUSION


PROPESS administration for a maximum of 12 h was an effective and well-tolerated treatment for pregnant Japanese women post-term requiring cervical ripening.",2020,"RESULTS


PROPESS administration for a maximum of 12 h showed significantly higher successful cervical ripening rate (47.4% vs 14.3%, respectively; treatment contrast [TC]: 33.1%; P = 0.0002).","['114 pregnant Japanese women at term (41\u2009weeks of gestation) requiring cervical ripening (baseline Bishop score (BS)\u2009≤\u20094', 'pregnant post-term Japanese women requiring cervical ripening', 'Japanese pregnant women requiring cervical ripening', 'pregnant Japanese women post-term requiring cervical ripening']","['controlled-release dinoprostone vaginal delivery system (PROPESS', 'placebo', 'dinoprostone vaginal insert (PROPESS']","['successful cervical ripening rate', 'efficacy and safety', 'proportion of subjects with successful cervical ripening defined as BS\u2009≥\u20097 or vaginal delivery', 'Efficacy and safety', 'median time from administration to vaginal delivery', 'changes in BS, proportion of women with vaginal delivery, proportion of women receiving mechanical cervical ripening procedure and use of oxytocic drugs']","[{'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0600454', 'cui_str': 'Cervical Ripening'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C2225498', 'cui_str': 'Bishop score'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0012472', 'cui_str': 'Dinoprostone'}, {'cui': 'C0566690', 'cui_str': 'Vaginal delivery'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4746121', 'cui_str': 'Dinoprostone Vaginal Insert'}]","[{'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0600454', 'cui_str': 'Cervical Ripening'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0566690', 'cui_str': 'Vaginal delivery'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0030094', 'cui_str': 'Oxytocic agent'}]",114.0,0.528065,"RESULTS


PROPESS administration for a maximum of 12 h showed significantly higher successful cervical ripening rate (47.4% vs 14.3%, respectively; treatment contrast [TC]: 33.1%; P = 0.0002).","[{'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Itoh', 'Affiliation': 'Department of Obstetrics and Gynecology, Hamamatsu University School of Medicine, Higashi-ku, Hamamatsu, Japan.'}, {'ForeName': 'Keisuke', 'Initials': 'K', 'LastName': 'Ishii', 'Affiliation': ""Osaka Women's and Children's Hospital, Izumi, Japan.""}, {'ForeName': 'Naoya', 'Initials': 'N', 'LastName': 'Shigeta', 'Affiliation': 'Rinku General Medical Center, Izumisanoshi, Osaka, Japan.'}, {'ForeName': 'Atsuo', 'Initials': 'A', 'LastName': 'Itakura', 'Affiliation': 'Juntendo University, Bunkyo-ku, Tokyo, Japan.'}, {'ForeName': 'Hiromi', 'Initials': 'H', 'LastName': 'Hamada', 'Affiliation': 'University of Tsukuba, Tsukuba, Ibaraki, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Nagamatsu', 'Affiliation': 'The University of Tokyo, Bunkyo-ku, Tokyo, Japan.'}, {'ForeName': 'Tomohiko', 'Initials': 'T', 'LastName': 'Ishida', 'Affiliation': 'Itabashi Chuo Medical Center, Itabashi-ku, Tokyo, Japan.'}, {'ForeName': 'Yasuaki', 'Initials': 'Y', 'LastName': 'Bungyoku', 'Affiliation': 'Ferring Pharmaceuticals Co. Ltd., Minato-ku, Tokyo, Japan.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Falahati', 'Affiliation': 'Ferring Pharmaceuticals Co. Ltd., Minato-ku, Tokyo, Japan.'}, {'ForeName': 'Miori', 'Initials': 'M', 'LastName': 'Tomisaka', 'Affiliation': 'Ferring Pharmaceuticals Co. Ltd., Minato-ku, Tokyo, Japan.'}, {'ForeName': 'Mikiya', 'Initials': 'M', 'LastName': 'Kitamura', 'Affiliation': 'Ferring Pharmaceuticals Co. Ltd., Minato-ku, Tokyo, Japan.'}]",The journal of obstetrics and gynaecology research,['10.1111/jog.14472']
2192,33094551,Evaluation of resin sealer penetration of dentin following different final rinses for endodontic irrigation using confocal laser scanning microscopy.,"The aim of the study was to assess the depth of sealer penetration into dentinal tubules following different final rinses and indirectly evaluate precipitation of irrigating solutions. Methods: 52 extracted maxillary incisors were prepared to size 40/04 with 6% sodium hypochlorite irrigating solution. Following power analysis, teeth were randomly divided into 4 groups (n = 13) according to final rinse. Group 1 - 17% EDTA, Saline and 2% Chlorhexidine solution; Group 2 - SmearOFF™; Group 3 - Qmix ®  ; and Group 4 - saline control. Obturation was performed with gutta percha and resin sealer mixed with rhodamine-B-isothiocyanate dye using warm vertical compaction. Teeth were sectioned into apical, middle, and coronal thirds using Buehler diamond saw at 3, 6 and 9 mm from the apex. Sections were examined under confocal laser scanning microscopy, and images were exported to Image J software to measure the maximum depth of sealer penetration circumferentially. Data were analysed using a generalised linear model and post hoc multiple comparisons with significance set at P < 0.05. Group 3 had the highest depth of penetration. There were statistically significant differences between Groups 2 and 3 and control for all sections, Group 1 and control in apical section only. Conclusion: Recently developed final rinses produced higher sealer penetration and more patent dentinal tubules than using EDTA and chlorhexidine sequentially.",2020,"There were statistically significant differences between Groups 2 and 3 and control for all sections, Group 1 and control in apical section only.",[],"['EDTA, Saline and 2% Chlorhexidine solution; Group 2 - SmearOFF™; Group 3 - Qmix ®  ; and Group 4 - saline control', 'sodium hypochlorite irrigating solution', 'EDTA and chlorhexidine', 'gutta percha and resin sealer mixed with rhodamine-B-isothiocyanate dye using warm vertical compaction']",['highest depth of penetration'],[],"[{'cui': 'C0013618', 'cui_str': 'Edetic Acid'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0441876', 'cui_str': 'Group 4'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0037518', 'cui_str': 'sodium hypochlorite'}, {'cui': 'C0593225', 'cui_str': 'Solution for irrigation'}, {'cui': 'C0018407', 'cui_str': 'Gutta percha'}, {'cui': 'C0035191', 'cui_str': 'Resins, Plant'}, {'cui': 'C0449942', 'cui_str': 'Sealer'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0073197', 'cui_str': 'rhodamine isothiocyanate'}, {'cui': 'C0013343', 'cui_str': 'Dye'}, {'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0205321', 'cui_str': 'Penetrating'}]",52.0,0.0303587,"There were statistically significant differences between Groups 2 and 3 and control for all sections, Group 1 and control in apical section only.","[{'ForeName': 'Omar E', 'Initials': 'OE', 'LastName': 'Abusteit', 'Affiliation': 'Division of Endodontics, Department of Restorative Sciences, School of Dentistry, University of Minnesota, Minneapolis, Minnesota, USA.'}]",Australian endodontic journal : the journal of the Australian Society of Endodontology Inc,['10.1111/aej.12453']
2193,33094562,Reduction of Blood Loss by Intra-articular Injection of Tranexamic Acid Combined with Knee and Hip Flexion at 45° During Primary Total Knee Arthroplasty: A Randomized Controlled Trial.,"OBJECTIVE


To explore the hemostatic effect of intra-articular administration of tranexamic acid (TXA) combined with knee flexion in total knee arthroplasty (TKA).
METHODS


This randomized controlled trial was conducted at the Third Affiliated Hospital of Southern Medical University (Guangzhou, China) from January 2017 to February 2018. The patients were randomized 1:1 to the TXA group (TXA 500 mg into the joint after closure, knee, and hip flexed at 45° for 4 h) or the control group (physiological saline, with limb fully extended). The primary endpoint was postoperative hemoglobin reduction. The postoperative levels of hemoglobin were measured at four time points: 6 h after operation, and on the first, second, and third postoperative days. Calculated blood loss (CBL) at 3 days, transfusion rate, range of motion (ROM), VAS pain score, and knee circumference increment were the secondary endpoints. Ninety-four (47/group) patients were analyzed.
RESULTS


Postoperatively, there were statistically significant differences between the TXA and control groups in CBL (791 ± 212 mL vs 1175 ± 273 mL, P < 0.05). Hemoglobin reduction was significantly lower in the TXA group (2.0 ± 0.9 g/dL vs 4.5 ± 0.7 g/dL, P < 0.05). Based on the transfusion criteria, 3 out of 47 (6.4%) patients in the TXA group and 13 out of 47 (27.6%) patients in the control group received blood transfusions (P = 0.006). ROM (90.8° ± 6.2° vs 87.6° ± 6.4°, P = 0.004), VAS pain score (4.1 ± 1.1 vs 4.8 ± 1.3, P = 0.004), and KCI (2.4 ± 0.9 cm vs 3.2 ± 1.0 cm, P = 0.01) were better in the TXA group compared with thecontrols. There was no deep venous thrombosis (DVT), wound infection or other adverse events in either group. In the control group, 2 patients had a fever after blood transfusion.
CONCLUSION


Intra-articular injection of TXA combined with knee and hip flexion at 45° can effectively attenuate CBL and hemoglobin reduction during primary TKA, without an additional adverse event.",2020,"There was no deep venous thrombosis (DVT), wound infection or other adverse events in either group.","['total knee arthroplasty (TKA', 'Third Affiliated Hospital of Southern Medical University (Guangzhou, China) from January 2017 to February 2018', 'at 45° During Primary Total Knee Arthroplasty', 'Ninety-four (47/group) patients were analyzed']","['TXA group (TXA 500 mg into the joint after closure, knee, and hip flexed at 45° for 4 h) or the control group (physiological saline, with limb fully extended', 'Tranexamic Acid Combined with Knee and Hip Flexion', 'tranexamic acid (TXA) combined with knee flexion', 'TXA']","['postoperative hemoglobin reduction', 'Calculated blood loss (CBL) at 3\u2009days, transfusion rate, range of motion (ROM), VAS pain score, and knee circumference increment', 'VAS pain score', 'postoperative levels of hemoglobin', 'CBL and hemoglobin reduction', 'fever after blood transfusion', 'ROM', 'deep venous thrombosis (DVT), wound infection or other adverse events', 'Hemoglobin reduction', 'Blood Loss', 'blood transfusions']","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0993065', 'cui_str': 'Tranexamic Acid 500 MG'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0043241', 'cui_str': 'Local infection of wound'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0723216,"There was no deep venous thrombosis (DVT), wound infection or other adverse events in either group.","[{'ForeName': 'Jian-Qi', 'Initials': 'JQ', 'LastName': 'Yang', 'Affiliation': 'Department of Orthopaedics, The Third Affiliated Hospital of Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': ""Department of Orthopaedics, The First People's Hospital of Foshan, Foshan, China.""}, {'ForeName': 'Jian-Shao', 'Initials': 'JS', 'LastName': 'Tan', 'Affiliation': ""Department of Orthopaedics, The First People's Hospital of Foshan, Foshan, China.""}, {'ForeName': 'Kun-Ping', 'Initials': 'KP', 'LastName': 'Huo', 'Affiliation': 'Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': 'Department of Orthopaedics, The Third Affiliated Hospital of Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Dao-Zhang', 'Initials': 'DZ', 'LastName': 'Cai', 'Affiliation': 'Department of Orthopaedics, The Third Affiliated Hospital of Southern Medical University, Guangzhou, China.'}]",Orthopaedic surgery,['10.1111/os.12814']
2194,33094652,Differential effects of mindfulness meditation conditions on repetitive negative thinking and subjective time perspective: a randomized active-controlled study.,"OBJECTIVE


Preliminary findings suggest that different kinds of meditation could work on diverse cognitive and psychological processes. The present study aimed at disentangling the effects of three mindfulness techniques on mental rumination and subjective time perspective.  Design:  75 young healthy participants were randomly assigned to one of four conditions: mindful breathing, body scan, observing-thoughts meditation and an active control condition. The meditation groups practiced mindfulness daily and attended weekly group meetings for 8 weeks, while the control group was involved in reading and discussing a book about mindfulness.  Main outcome measures:  Self-report measures of mindfulness skills, ruminative thinking, attitude towards time, anxiety, depression and personality traits.  Results:  In all meditation conditions, analysis of covariance showed a significant improvement in mindfulness skills compared to the control group. We found a specific effect of mindful breathing in reducing participants' tendency to brooding and in increasing their positive vision of the future, compared to all other conditions.  Conclusions:  As expected, we found some differential effects: breathing meditation helped practitioners to train more effectively their ability to disengage from maladaptive ruminative thoughts, which could be reflected in a more optimistic attitude toward the future. These results provide useful information to structure better mindfulness-based interventions.",2020,"We found a specific effect of mindful breathing in reducing participants' tendency to brooding and in increasing their positive vision of the future, compared to all other conditions.  ",['75 young healthy participants'],"['meditation groups practiced mindfulness daily and attended weekly group meetings for 8\u2009weeks, while the control group was involved in reading and discussing a book about mindfulness', 'mindful breathing, body scan, observing-thoughts meditation and an active control condition', 'mindfulness meditation conditions']","['mental rumination and subjective time perspective', 'repetitive negative thinking and subjective time perspective', 'Self-report measures of mindfulness skills, ruminative thinking, attitude towards time, anxiety, depression and personality traits', 'mindfulness skills']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0018262', 'cui_str': 'Group Practice'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0018261', 'cui_str': 'Group Meetings'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0006002', 'cui_str': 'Book'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0039869', 'cui_str': 'Thinking'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0154575', 'cui_str': 'Rumination disorder'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0040226', 'cui_str': 'Time Perception'}, {'cui': 'C0424134', 'cui_str': 'Pessimistic'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0233849', 'cui_str': 'Character trait finding'}]",75.0,0.0180762,"We found a specific effect of mindful breathing in reducing participants' tendency to brooding and in increasing their positive vision of the future, compared to all other conditions.  ","[{'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Feruglio', 'Affiliation': 'Department of Languages and Literatures, Communication, Education and Society, University of Udine, Udine, Italy.'}, {'ForeName': 'Alessio', 'Initials': 'A', 'LastName': 'Matiz', 'Affiliation': 'Department of Languages and Literatures, Communication, Education and Society, University of Udine, Udine, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Grecucci', 'Affiliation': 'Department of Psychology and Cognitive Science, University of Trento, Trento, Italy.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Pascut', 'Affiliation': 'Municipality of Udine, WHO Healthy Cities Project, Udine, Italy.'}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Fabbro', 'Affiliation': 'Department of Languages and Literatures, Communication, Education and Society, University of Udine, Udine, Italy.'}, {'ForeName': 'Cristiano', 'Initials': 'C', 'LastName': 'Crescentini', 'Affiliation': 'Department of Languages and Literatures, Communication, Education and Society, University of Udine, Udine, Italy.'}]",Psychology & health,['10.1080/08870446.2020.1836178']
2195,33094658,The treatment of menopausal symptoms by traditional Chinese medicine in Asian countries.,"Menopausal symptoms (or climacteric syndrome) refer to a series of symptoms that occur during the perimenopausal and early postmenopausal period. About 80% of women will have various degrees of menopausal symptoms, and most of them need associated treatment. Asian women are more inclined to choose traditional Chinese medicine (TCM) in terms of therapeutic method, and menopausal hormone therapy has low acceptance because the women have been misinformed about the side effects of hormones. Therefore, TCM is used for menopausal symptoms in women in most Asian countries, including China, Japan, Vietnam, and South Korea. In the basic theory of TCM, the menopause is classified as the Kidney deficiency and imbalance of Yin and Yang; therefore, the treatment methods in either Chinese patent medicine or Chinese herbal medicine are aimed at supplementing the Kidney function and rebalancing Yin and Yang. It is believed that TCM treatment is suitable for patients with mild or moderate menopausal symptoms. The incidence rate of adverse reactions in terms of breast tenderness and irregular vaginal bleeding is lower than that of hormone therapy. However, there are few randomized, double-blind, placebo-controlled studies on TCM treatment of menopausal syndrome. Future studies should be undertaken to confirm its merits.",2020,The incidence rate of adverse reactions in terms of breast tenderness and irregular vaginal bleeding is lower than that of hormone therapy.,"['Asian countries', 'Asian women', 'women in most Asian countries, including China, Japan, Vietnam, and South Korea', 'patients with mild or moderate menopausal symptoms']","['placebo', 'traditional Chinese medicine (TCM', 'TCM', 'traditional Chinese medicine']","['breast tenderness and irregular vaginal bleeding', 'incidence rate of adverse reactions', 'Menopausal symptoms (or climacteric syndrome']","[{'cui': 'C0454705', 'cui_str': 'Asian country'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0042658', 'cui_str': 'Vietnam'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0236075', 'cui_str': 'Menopausal symptom'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}]","[{'cui': 'C0262397', 'cui_str': 'Breast tenderness'}, {'cui': 'C0205271', 'cui_str': 'Irregular'}, {'cui': 'C2979982', 'cui_str': 'Vaginal bleeding'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0236075', 'cui_str': 'Menopausal symptom'}, {'cui': 'C0025319', 'cui_str': 'Menopausal syndrome'}]",,0.142469,The incidence rate of adverse reactions in terms of breast tenderness and irregular vaginal bleeding is lower than that of hormone therapy.,"[{'ForeName': 'Y-P', 'Initials': 'YP', 'LastName': 'Wang', 'Affiliation': 'Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Q', 'Initials': 'Q', 'LastName': 'Yu', 'Affiliation': 'Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China.'}]",Climacteric : the journal of the International Menopause Society,['10.1080/13697137.2020.1832461']
2196,33094666,An evaluation of olaparib for the treatment of pancreatic cancer.,"INTRODUCTION


Advanced pancreatic cancer remains a lethal, incurable malignancy. Chemotherapy is the mainstay of systemic therapy consideration in metastatic pancreas cancer. Homologous recombinant DNA repair mutations are reported in about 7% of pancreas cancer cases and have rapidly emerged as actionable mutations.
AREAS COVERED


A review was conducted of publications of PARP inhibitors in pancreatic malignancies with a focus on clinical trials with olaparib. This included a review of the phase II and phase III clinical trials of olaparib in pancreatic cancer.
EXPERT OPINION


Olaparib was compared to placebo in a randomized double blind trial in cases with advanced pancreatic cancer and germline  BRCA1/2  mutations, with a clinical response or stable disease after at least 16 weeks of platinum based chemotherapy. Olaparib significantly improved progression free survival, [HR=-.53, p=0.0035] but did not improve overall survival. No differences in quality of life were noted between the two arms. Adverse events from olaparib were noted in 40% of treated patients. Objective response rate was 20% in olaparib arm and 10% in placebo treated arm. A careful consideration of the risks and benefits of this personalized therapy is advisable, prior to clinical application in germline BRCA1/2 mutated advanced pancreatic cancer.",2020,"Olaparib significantly improved progression free survival, [HR=-.53, p=0.0035] but did not improve overall survival.","['cases with advanced pancreatic cancer and germline  BRCA1/2  mutations, with a clinical response or stable disease after at least 16 weeks of platinum based chemotherapy', 'metastatic pancreas cancer', 'pancreatic cancer', 'germline BRCA1/2 mutated advanced pancreatic cancer']","['PARP inhibitors', 'Chemotherapy', 'placebo', 'Olaparib']","['Objective response rate', 'quality of life', 'progression free survival', 'overall survival']","[{'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0235974', 'cui_str': 'Carcinoma of pancreas'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0346976', 'cui_str': 'Secondary malignant neoplasm of pancreas'}]","[{'cui': 'C1882413', 'cui_str': 'Nicotinamide adenine dinucleotide adenosine diphosphate ribosyltransferase inhibitor-containing product'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2316164', 'cui_str': 'olaparib'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.296974,"Olaparib significantly improved progression free survival, [HR=-.53, p=0.0035] but did not improve overall survival.","[{'ForeName': 'Ulka N', 'Initials': 'UN', 'LastName': 'Vaishampayan', 'Affiliation': ''}]",Expert opinion on pharmacotherapy,['10.1080/14656566.2020.1837113']
2197,33094682,Preoperative intravenous meloxicam for moderate-to-severe pain in the immediate post-operative period: a Phase IIIb randomized clinical trial in 55 patients undergoing primary open or laparoscopic colorectal surgery with bowel resection and/or anastomosis.,"Aim:  Evaluate safety/efficacy of intravenous meloxicam in a colorectal enhanced recovery after surgery protocol.  Methods:  Adults undergoing primary open or laparoscopic colorectal surgery with bowel resection and/or anastomosis received meloxicam IV 30 mg (n = 27) or placebo (n = 28) once daily beginning 30 min before surgery.  Results:  Adverse events: meloxicam IV, 85%; placebo, 93%. Adverse events commonly associated with opioids: 41 versus 61% - including nausea (33 vs 50%), vomiting (19 vs 18%) and ileus (4 vs 18%). Wound healing satisfaction scores (physician-rated), clinical laboratory findings and vital signs were similar in both groups. No anastomotic leaks were reported. Opioid consumption, postoperative pain intensity, length of stay and times to first bowel sound, first flatus and first bowel movement were significantly lower with meloxicam IV versus placebo. Most subjects (>92%) were satisfied with postoperative pain medication.  Conclusion:  Meloxicam IV was generally well tolerated and associated with decreased opioid consumption, lower resource utilization and functional benefits.  Clinical Trial Registration:  NCT03323385 (ClinicalTrials.gov).",2020,"Wound healing satisfaction scores (physician-rated), clinical laboratory findings and vital signs were similar in both groups.","['55 patients undergoing primary open or', 'Adults undergoing primary open or']","['meloxicam IV 30\xa0mg (n\xa0=\xa027) or placebo', 'meloxicam', 'laparoscopic colorectal surgery with bowel resection', 'opioids', 'laparoscopic colorectal surgery with bowel resection and/or anastomosis', 'placebo', 'Meloxicam IV', 'meloxicam IV versus placebo']","['Wound healing satisfaction scores (physician-rated), clinical laboratory findings and vital signs', 'anastomotic leaks', 'ileus', 'nausea', 'Opioid consumption, postoperative pain intensity, length of stay and times to first bowel sound, first flatus and first bowel movement', 'postoperative pain medication', 'tolerated and associated with decreased opioid consumption, lower resource utilization and functional benefits', 'vomiting']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0083381', 'cui_str': 'meloxicam'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0009369', 'cui_str': 'Colorectal surgery'}, {'cui': 'C0741614', 'cui_str': 'Bowel resection'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis'}]","[{'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0587081', 'cui_str': 'Laboratory test finding'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0919691', 'cui_str': 'Anastomotic leak'}, {'cui': 'C1258215', 'cui_str': 'Ileus'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0232693', 'cui_str': 'Bowel sounds'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}]",,0.285892,"Wound healing satisfaction scores (physician-rated), clinical laboratory findings and vital signs were similar in both groups.","[{'ForeName': 'Jennifer D', 'Initials': 'JD', 'LastName': 'Silinsky', 'Affiliation': 'Department of Surgery, Tulane University, New Orleans, LA, 70112, USA.'}, {'ForeName': 'Jorge E', 'Initials': 'JE', 'LastName': 'Marcet', 'Affiliation': 'Department of Surgery, Tampa General Hospital, Tampa, FL, 33606, USA.'}, {'ForeName': 'Vamshi Ruthwik', 'Initials': 'VR', 'LastName': 'Anupindi', 'Affiliation': 'IQVIA, Falls Church, VA, 22042, USA.'}, {'ForeName': 'Swapna U', 'Initials': 'SU', 'LastName': 'Karkare', 'Affiliation': 'IQVIA, Falls Church, VA, 22042, USA.'}, {'ForeName': 'Drishti R', 'Initials': 'DR', 'LastName': 'Shah', 'Affiliation': 'IQVIA, Falls Church, VA, 22042, USA.'}, {'ForeName': 'Randall J', 'Initials': 'RJ', 'LastName': 'Mack', 'Affiliation': 'Baudax Bio\xa0Inc., Malvern, PA, 19355, USA.'}, {'ForeName': 'Stewart W', 'Initials': 'SW', 'LastName': 'McCallum', 'Affiliation': 'Baudax Bio\xa0Inc., Malvern, PA, 19355, USA.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Du', 'Affiliation': 'Clinical Statistics Consulting, Blue Bell, PA, 19422, USA.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Freyer', 'Affiliation': 'Baudax Bio\xa0Inc., Malvern, PA, 19355, USA.'}, {'ForeName': 'Libby K', 'Initials': 'LK', 'LastName': 'Black', 'Affiliation': 'Baudax Bio\xa0Inc., Malvern, PA, 19355, USA.'}]",Pain management,['10.2217/pmt-2020-0061']
2198,33094733,Use of a Smartphone App to Increase Physical Activity Levels in Insufficiently Active Adults: Feasibility Sequential Multiple Assignment Randomized Trial (SMART).,"BACKGROUND


The sequential multiple assignment randomized trial (SMART) design allows for changes in the intervention during the trial period. Despite its potential and feasibility for defining the best sequence of interventions, so far, it has not been utilized in a smartphone/gamified intervention for physical activity.
OBJECTIVE


We aimed to investigate the feasibility of the SMART design for assessing the effects of a smartphone app intervention to improve physical activity in adults. We also aimed to describe the participants' perception regarding the protocol and the use of the app for physical activity qualitatively.
METHODS


We conducted a feasibility 24-week/two-stage SMART in which 18 insufficiently active participants (<10,000 steps/day) were first randomized to group 1 (smartphone app only), group 2 (smartphone app + tailored messages), and a control group (usual routine during the protocol). Participants were motivated to increase their step count by at least 2000 steps/day each week. Based on the 12-week intermediate outcome, responders continued the intervention and nonresponders were rerandomized to subsequent treatment, including a new group 3 (smartphone app + tailored messages + gamification) in which they were instructed to form groups to use several game elements available in the chosen app (Pacer). We considered responders as those with any positive slope in the linear relationship between weeks and steps per day at the end of the first stage of the intervention. We compared the accelerometer-based steps per day before and after the intervention, as well as the slopes of the app-based steps per day between the first and second stages of the intervention.
RESULTS


Twelve participants, including five controls, finished the intervention. We identified two responders in group 1. We did not observe relevant changes in the steps per day either throughout the intervention or compared with the control group. However, the rerandomization of five nonresponders led to a change in the slope of the steps per day (median -198 steps/day [IQR -279 to -103] to 20 steps/day [IQR -204 to 145]; P=.08). Finally, in three participants from group 2, we observed an increase in the number of steps per day up to the sixth week, followed by an inflection to baseline values or even lower (ie, a quadratic relationship). The qualitative analysis showed that participants' reports could be classified into the following: (1) difficulty in managing the app and technology or problems with the device, (2) suitable response to the app, and (3) difficulties to achieve the goals.
CONCLUSIONS


The SMART design was feasible and changed the behavior of steps per day after rerandomization. Rerandomization should be implemented earlier to take advantage of tailored messages. Additionally, difficulties with technology and realistic and individualized goals should be considered in interventions for physical activity using smartphones.
TRIAL REGISTRATION


Brazilian Registry of Clinical Trials RBR-8xtc9c; http://www.ensaiosclinicos.gov.br/rg/RBR-8xtc9c/.",2020,We did not observe relevant changes in the steps per day either throughout the intervention or compared with the control group.,"['Insufficiently Active Adults', 'adults', '18 insufficiently active participants (<10,000 steps/day']","['smartphone app only), group 2 (smartphone app + tailored messages), and a control group (usual routine during the protocol', 'new group 3 (smartphone app + tailored messages + gamification', 'RBR-8xtc9c', 'smartphone app intervention', 'Smartphone App']","['Physical Activity Levels', 'physical activity']","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",18.0,0.0312725,We did not observe relevant changes in the steps per day either throughout the intervention or compared with the control group.,"[{'ForeName': 'Bárbara De Barros', 'Initials': 'BB', 'LastName': 'Gonze', 'Affiliation': 'Laboratory of Epidemiology and Human Movement (EPIMOV), Department of Human Movement Sciences, Federal University of São Paulo, Santos, Brazil.'}, {'ForeName': 'Ricardo Da Costa', 'Initials': 'RDC', 'LastName': 'Padovani', 'Affiliation': 'Department of Health, Education and Society, Federal University of São Paulo, Santos, Brazil.'}, {'ForeName': 'Maria Do Socorro', 'Initials': 'MDS', 'LastName': 'Simoes', 'Affiliation': 'Laboratory of Epidemiology and Human Movement (EPIMOV), Department of Human Movement Sciences, Federal University of São Paulo, Santos, Brazil.'}, {'ForeName': 'Vinicius', 'Initials': 'V', 'LastName': 'Lauria', 'Affiliation': 'Laboratory of Epidemiology and Human Movement (EPIMOV), Department of Human Movement Sciences, Federal University of São Paulo, Santos, Brazil.'}, {'ForeName': 'Neli Leite', 'Initials': 'NL', 'LastName': 'Proença', 'Affiliation': 'Laboratory of Epidemiology and Human Movement (EPIMOV), Department of Human Movement Sciences, Federal University of São Paulo, Santos, Brazil.'}, {'ForeName': 'Evandro Fornias', 'Initials': 'EF', 'LastName': 'Sperandio', 'Affiliation': 'Laboratory of Epidemiology and Human Movement (EPIMOV), Department of Human Movement Sciences, Federal University of São Paulo, Santos, Brazil.'}, {'ForeName': 'Thatiane Lopes Valentim Di Paschoale', 'Initials': 'TLVDP', 'LastName': 'Ostolin', 'Affiliation': 'Laboratory of Epidemiology and Human Movement (EPIMOV), Department of Human Movement Sciences, Federal University of São Paulo, Santos, Brazil.'}, {'ForeName': 'Grace Angélica De Oliveira', 'Initials': 'GAO', 'LastName': 'Gomes', 'Affiliation': 'Department of Gerontology, Federal University of São Carlos, São Carlos, Brazil.'}, {'ForeName': 'Paula Costa', 'Initials': 'PC', 'LastName': 'Castro', 'Affiliation': 'Department of Gerontology, Federal University of São Carlos, São Carlos, Brazil.'}, {'ForeName': 'Marcello', 'Initials': 'M', 'LastName': 'Romiti', 'Affiliation': 'Angiocorpore Institute of Cardiovascular Medicine, Santos, Brazil.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Gagliardi', 'Affiliation': 'Angiocorpore Institute of Cardiovascular Medicine, Santos, Brazil.'}, {'ForeName': 'Rodolfo Leite', 'Initials': 'RL', 'LastName': 'Arantes', 'Affiliation': 'Angiocorpore Institute of Cardiovascular Medicine, Santos, Brazil.'}, {'ForeName': 'Victor Zuniga', 'Initials': 'VZ', 'LastName': 'Dourado', 'Affiliation': 'Laboratory of Epidemiology and Human Movement (EPIMOV), Department of Human Movement Sciences, Federal University of São Paulo, Santos, Brazil.'}]",JMIR research protocols,['10.2196/14322']
2199,33094734,Digital Self-Management in Support of Patients Living With Chronic Pain: Feasibility Pilot Study.,"BACKGROUND


Chronic pain can be complex and taxing to live with, and treatment and support require a multicomponent approach, which may not always be offered or available. Smartphones, tablets, and personal computers are already incorporated into patients' daily lives, and therefore, they can be used to communicate, educate, and support self-management. Although some web-based self-management interventions exist, research examining the evidence and effect of digital solutions supporting self-management for patients living with chronic pain is limited, findings are inconclusive, and new innovative ideas and solutions are needed.
OBJECTIVE


This feasibility pilot study aimed to explore the system use, perceived usefulness, ease of use, and preliminary effects of EPIO, an app-based cognitive-behavioral pain self-management intervention program for patients living with chronic pain.
METHODS


The EPIO intervention was delivered in a blended-care model containing (1) one face-to-face introduction session, (2) nine cognitive behavior-based pain self-management modules, delivered in an app-based format for smartphones or tablets, and (3) one follow-up phone call at 2 to 3 weeks after the introduction session. Patients living with chronic pain (N=50) completed pre-post outcome measures at baseline and 3 months after the introduction session, with registration of system use (ie, log data) until 6 months. The use, perceived usefulness, and ease of use of the EPIO program were examined through system use data, as well as a study-specific use/usability questionnaire and the System Usability Scale (SUS). Outcome measures to test feasibility of use and estimate preliminary effects included the Brief Pain Inventory, health-related quality of life (HRQoL) scale, Hospital Anxiety and Depression Scale, Self-Regulatory Fatigue scale, Pain Catastrophizing Scale, and Chronic Pain Acceptance Questionnaire.
RESULTS


Participants (N=50) had a median age of 52 years (range 29-74 years) at inclusion and were mainly female (40/50, 80%). Thirty-one participants completed at least six of the nine modules within the 3-month study period (62% completion rate). Forty-five participants completed outcome measures at 3 months, and the EPIO program was rated as useful (ie, ""totally agree"" or ""agree""; 39/45, 87%) and easy to use (42/45, 93%), and as having easily understandable exercises (44/45, 98%). The average overall system usability (SUS) score was 85.7, indicating grade A and excellent system usability. Preliminary psychosocial outcome measure estimates showed primarily nonsignificant pre-post intervention improvements at 3 months, but with significant positive effects related to some aspects of HRQoL (bodily pain, P=.02 and change, P=.049).
CONCLUSIONS


Digital self-management intervention programs may be of use and support for patients living with chronic pain. In this feasibility study, EPIO showed an acceptable program completion rate and was rated as useful and easy to use, with excellent user satisfaction. Program optimization and efficacy testing in a large-scale randomized controlled trial are warranted and in progress.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03705104; https://clinicaltrials.gov/ct2/show/NCT03705104.",2020,"Preliminary psychosocial outcome measure estimates showed primarily nonsignificant pre-post intervention improvements at 3 months, but with significant positive effects related to some aspects of HRQoL (bodily pain, P=.02 and change, P=.049).
","['Patients living with chronic pain (N=50', 'patients living with chronic pain', 'Patients Living With Chronic Pain', 'Participants (N=50) had a median age of 52 years (range 29-74 years) at inclusion and were mainly female (40/50, 80']","['blended-care model containing (1) one face-to-face introduction session, (2) nine cognitive behavior-based pain self-management modules, delivered in an app-based format for smartphones or tablets, and (3) one follow-up phone call', 'Digital Self-Management', 'EPIO, an app-based cognitive-behavioral pain self-management intervention program']","['Brief Pain Inventory, health-related quality of life (HRQoL) scale, Hospital Anxiety and Depression Scale, Self-Regulatory Fatigue scale, Pain Catastrophizing Scale, and Chronic Pain Acceptance Questionnaire', 'average overall system usability (SUS) score', 'usability questionnaire and the System Usability Scale (SUS', 'HRQoL (bodily pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C1301627', 'cui_str': 'Format'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",31.0,0.111042,"Preliminary psychosocial outcome measure estimates showed primarily nonsignificant pre-post intervention improvements at 3 months, but with significant positive effects related to some aspects of HRQoL (bodily pain, P=.02 and change, P=.049).
","[{'ForeName': 'Katrine', 'Initials': 'K', 'LastName': 'Bostrøm', 'Affiliation': 'Department of Digital Health Research, Division of Medicine, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Elin', 'Initials': 'E', 'LastName': 'Børøsund', 'Affiliation': 'Department of Digital Health Research, Division of Medicine, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Cecilie', 'Initials': 'C', 'LastName': 'Varsi', 'Affiliation': 'Department of Digital Health Research, Division of Medicine, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Hilde', 'Initials': 'H', 'LastName': 'Eide', 'Affiliation': 'Department of Digital Health Research, Division of Medicine, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Flakk Nordang', 'Affiliation': 'Department of Digital Health Research, Division of Medicine, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Karlein Mg', 'Initials': 'KM', 'LastName': 'Schreurs', 'Affiliation': 'Department of Psychology, Health & Technology, University of Twente, Enschede, Netherlands.'}, {'ForeName': 'Lori B', 'Initials': 'LB', 'LastName': 'Waxenberg', 'Affiliation': 'Department of Clinical and Health Psychology, University of Florida, Gainesville, FL, United States.'}, {'ForeName': 'Karen E', 'Initials': 'KE', 'LastName': 'Weiss', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, University of Washington School of Medicine, Seattle, WA, United States.'}, {'ForeName': 'Eleshia J', 'Initials': 'EJ', 'LastName': 'Morrison', 'Affiliation': 'Department of Psychiatry and Psychology, College of Medicine and Science, Mayo Clinic, Rochester, MN, United States.'}, {'ForeName': 'Milada', 'Initials': 'M', 'LastName': 'Cvancarova Småstuen', 'Affiliation': 'Faculty of Health Sciences, Oslo Metropolitan University, Oslo, Norway.'}, {'ForeName': 'Audun', 'Initials': 'A', 'LastName': 'Stubhaug', 'Affiliation': 'Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Lise', 'Initials': 'L', 'LastName': 'Solberg Nes', 'Affiliation': 'Department of Digital Health Research, Division of Medicine, Oslo University Hospital, Oslo, Norway.'}]",JMIR formative research,['10.2196/23893']
2200,33094799,"An Expression of Concern from the AJCN Editorial Office about: Magnesium supplementation affects metabolic status and pregnancy outcomes in gestational diabetes: a randomized, double-blind, placebo-controlled trial.",,2020,,['gestational diabetes'],"['placebo', 'Magnesium supplementation']",['metabolic status and pregnancy outcomes'],"[{'cui': 'C0439671', 'cui_str': 'Gestational'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1096534', 'cui_str': 'Magnesium supplement therapy'}]","[{'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}]",,0.69049,,"[{'ForeName': 'Zatollah', 'Initials': 'Z', 'LastName': 'Asemi', 'Affiliation': ''}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Karamali', 'Affiliation': ''}, {'ForeName': 'Mehri', 'Initials': 'M', 'LastName': 'Jamilian', 'Affiliation': ''}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Foroozanfard', 'Affiliation': ''}, {'ForeName': 'Fereshteh', 'Initials': 'F', 'LastName': 'Bahmani', 'Affiliation': ''}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Heidarzadeh', 'Affiliation': ''}, {'ForeName': 'Sanaz', 'Initials': 'S', 'LastName': 'Benisi-Kohansal', 'Affiliation': ''}, {'ForeName': 'Pamela J', 'Initials': 'PJ', 'LastName': 'Surkan', 'Affiliation': ''}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Esmaillzadeh', 'Affiliation': ''}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa320']
2201,33094821,"An Expression of Concern from the AJCN Editorial Office about: Effects of vitamin D supplementation on glucose metabolism, lipid concentrations, inflammation, and oxidative stress in gestational diabetes: a double-blind randomized controlled clinical trial.",,2020,,['gestational diabetes'],['vitamin D supplementation'],"['glucose metabolism, lipid concentrations, inflammation, and oxidative stress']","[{'cui': 'C0439671', 'cui_str': 'Gestational'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}]","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}]",,0.64095,,"[{'ForeName': 'Zatollah', 'Initials': 'Z', 'LastName': 'Asemi', 'Affiliation': ''}, {'ForeName': 'Teibeh', 'Initials': 'T', 'LastName': 'Hashemi', 'Affiliation': ''}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Karamali', 'Affiliation': ''}, {'ForeName': 'Mansooreh', 'Initials': 'M', 'LastName': 'Samimi', 'Affiliation': ''}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Esmaillzadeh', 'Affiliation': ''}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa319']
2202,33094825,Effect of awareness of being monitored on wearing time and wearing of orthopaedic footwear.,"OBJECTIVE


To investigate the effect of awareness of being monitored on wearing time and adherence to wearing orthopaedic footwear. Quantitative assessment of wearing time was made using direct measurement with temperature sensors during the first 3 months after provision of footwear.
DESIGN


Randomized controlled trial.
INTERVENTION


Awareness of the purpose of the study: measuring wearing time of their orthopaedic footwear.
METHODS


All 55 participants had a temperature sensor built into the medial arch of the left insole of their orthopaedic footwear. Participants were assigned randomly to either an ""awareness group"" (n = 25, mean age 67 years) and knew they were being monitored for wearing time, or a ""no awareness group"" (n = 30, mean age 65 years) and only knew their shoe temperature was being measured. Differences were assessed with a linear mixed model.
RESULTS


Mean (standard deviation; SD) wearing time in the intervention group was 7.32 h/day (SD 4.2), and 6.11 h/day (SD 4.1) in the control group (p = 0.017). A significant interaction effect was found for awareness and pathology group (p = 0.036). The difference was especially large (7.0 (SD 4.7) vs 2.4 (SD 2.2) h/day) in the subgroup of people with diabetes.
CONCLUSION


Awareness of being monitored increases wearing time and wearing of orthopaedic footwear.",2020,A significant interaction effect was found for awareness and pathology group (p = 0.036).,['All 55 participants had a temperature sensor built into the medial arch of the left insole of their orthopaedic footwear'],"['awareness group"" (n\u2009=\u200925, mean age 67 years) and knew they were being monitored for wearing time, or a ""no awareness group']","['wearing time and wearing of orthopaedic footwear', 'Mean (standard deviation; SD) wearing time']","[{'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0230467', 'cui_str': 'Structure of arch of foot'}, {'cui': 'C3873740', 'cui_str': 'Insole'}, {'cui': 'C0336894', 'cui_str': 'Footwear'}]","[{'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0040223', 'cui_str': 'Time'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0336894', 'cui_str': 'Footwear'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}]",,0.0368888,A significant interaction effect was found for awareness and pathology group (p = 0.036).,"[{'ForeName': 'Thijs', 'Initials': 'T', 'LastName': 'Lutjeboer', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Department of Rehabilitation Medicine, 9700 RB Groningen, The Netherlands. E-mail: t.lutjeboer@umcg.nl.'}, {'ForeName': 'Jaap J', 'Initials': 'JJ', 'LastName': 'van Netten', 'Affiliation': ''}, {'ForeName': 'Klaas', 'Initials': 'K', 'LastName': 'Postema', 'Affiliation': ''}, {'ForeName': 'Juha M', 'Initials': 'JM', 'LastName': 'Hijmans', 'Affiliation': ''}]",Journal of rehabilitation medicine,['10.2340/16501977-2759']
2203,33094860,The open versus blind weight conundrum: A multisite randomized controlled trial across multiple levels of patient care for anorexia nervosa.,"OBJECTIVE


Anorexia nervosa (AN) is a disorder characterized by a profound fear of weight gain, resulting in significant weight loss, as well as behavioral symptoms that interfere with weight normalization. In concert, weight gain remains a proximal goal of treatment, and patient weighing is a critical component of treatment. However, divergent approaches exist in how patient weighing is undertaken in clinical practice. The aim of this study is to investigate the impact of a brief course of open weighing (sharing weight data with patients) versus blind weighing (not sharing weight data with patients) on distress around being weighed and AN symptom severity.
METHOD


216 patients with AN and atypical AN will be randomized to receive 4 weeks of open or blind weighing practices across residential, intensive outpatient, and outpatient treatment settings, within the context of manualized empirically supported treatment. Following 4 weeks of open or blind weighing, all patients will be enrolled into open weighing practices. Primary outcomes of interest will be patient-reported distress around being weighed at week 5 and eating disorder symptom severity at week 5. Secondary outcomes will assess weight prediction error, intolerance of uncertainty, and the fear of food.
DISCUSSION


No best practice guidelines exist in determining optimal practices around weighing patients with AN. This multisite randomized controlled trial will provide the first known data on the impact of open versus blind weighing practices upon weight-related distress and AN symptom severity.",2020,Primary outcomes of interest will be patient-reported distress around being weighed at week 5 and eating disorder symptom severity at week 5.,"['patient care for anorexia nervosa', '216 patients with AN and atypical AN']",[],"['patient-reported distress around being weighed at week 5 and eating disorder symptom severity', 'weight prediction error, intolerance of uncertainty, and the fear of food']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003125', 'cui_str': 'Anorexia nervosa'}, {'cui': 'C4708905', 'cui_str': '216'}, {'cui': 'C0338959', 'cui_str': 'Atypical anorexia nervosa'}]",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0855228', 'cui_str': 'Eating disorder symptom'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0231199', 'cui_str': 'Intolerance'}, {'cui': 'C0087130', 'cui_str': 'Uncertain'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0016452', 'cui_str': 'Foods'}]",216.0,0.119373,Primary outcomes of interest will be patient-reported distress around being weighed at week 5 and eating disorder symptom severity at week 5.,"[{'ForeName': 'Stuart B', 'Initials': 'SB', 'LastName': 'Murray', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Southern California, Los Angeles, California, USA.'}, {'ForeName': 'Cheri A', 'Initials': 'CA', 'LastName': 'Levinson', 'Affiliation': 'Department of Psychological and Brain Sciences, University of Louisville, Louisville, Kentucky, USA.'}, {'ForeName': 'Nicholas R', 'Initials': 'NR', 'LastName': 'Farrell', 'Affiliation': 'Rogers Behavioral Health, Oconomowoc, Wisconsin, USA.'}, {'ForeName': 'Jason M', 'Initials': 'JM', 'LastName': 'Nagata', 'Affiliation': 'Department of Pediatrics, University of California, San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Emilio J', 'Initials': 'EJ', 'LastName': 'Compte', 'Affiliation': 'School of Psychology, Universidad Adolfo Ibáñez, Santiago, Chile.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Le Grange', 'Affiliation': 'Department of Psychiatry and Behavioral Science, Weill Institute for Neurosciences, University of California, San Francisco, California, USA.'}]",The International journal of eating disorders,['10.1002/eat.23397']
2204,33094868,"Perfectionism, anorexia nervosa, and family treatment: How perfectionism changes throughout treatment and predicts outcomes.","OBJECTIVE


This study uses data from a multisite randomized clinical trial to study the role of perfectionism in family-based treatment (FBT) for adolescent anorexia nervosa (AN). The main aim is to examine the role of baseline perfectionism in treatment response.
METHOD


Adolescents (N = 158; ages 12-18; 89.2% female) and their families were randomized to receive either FBT or systemic family treatment for AN. Eating disorder (ED) pathology, obsessive-compulsive symptoms, and perfectionism were assessed at baseline, end of treatment, and 6- and 12-month follow-up. Linear regression analyses were used to test whether perfectionism and obsessive-compulsive symptoms at baseline predict ED pathology at all timepoints. An independent samples t test was used to test whether there was a significant difference in the change in perfectionism in either treatment group.
RESULTS


Baseline maladaptive perfectionism significantly predicted ED pathology but not ideal body weight at all timepoints. The model that included obsessive-compulsive symptoms also predicted ED pathology at all timepoints except 12-month follow-up. Perfectionism scores did not change during treatment regardless of treatment type.
DISCUSSION


Baseline perfectionism predicted treatment response in this study. Interventions might target perfectionism to improve treatment response in AN.",2020,The model that included obsessive-compulsive symptoms also predicted ED pathology at all timepoints except 12-month follow-up.,"['adolescent anorexia nervosa (AN', 'Adolescents (N = 158; ages 12-18; 89.2% female) and their families']","['FBT or systemic family treatment for AN', 'perfectionism in family-based treatment (FBT']","['perfectionism and obsessive-compulsive symptoms', 'Perfectionism scores', 'Eating disorder (ED) pathology, obsessive-compulsive symptoms, and perfectionism', 'Perfectionism, anorexia nervosa']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0003125', 'cui_str': 'Anorexia nervosa'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0015576', 'cui_str': 'Family'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0003125', 'cui_str': 'Anorexia nervosa'}, {'cui': 'C0815110', 'cui_str': 'Perfectionism'}]","[{'cui': 'C0815110', 'cui_str': 'Perfectionism'}, {'cui': 'C4087290', 'cui_str': 'Obsessive-compulsive symptom'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0013473', 'cui_str': 'Eating disorder'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0003125', 'cui_str': 'Anorexia nervosa'}]",158.0,0.0432251,The model that included obsessive-compulsive symptoms also predicted ED pathology at all timepoints except 12-month follow-up.,"[{'ForeName': 'Hannah A', 'Initials': 'HA', 'LastName': 'Welch', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, California, USA.'}, {'ForeName': 'W Stewart', 'Initials': 'WS', 'LastName': 'Agras', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, California, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Lock', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, California, USA.'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Halmi', 'Affiliation': 'Department of Psychiatry, Weil Cornell Medical College, New York, New York, USA.'}]",The International journal of eating disorders,['10.1002/eat.23396']
2205,33094898,"The effectiveness of manual therapy in addition to passive stretching exercises in the treatment of patients with haemophilic knee arthropathy: A randomized, single-blind clinical trial.","BACKGROUND


Haemophilic arthropathy is characterized by joint restrictions. One of the most affected joints in haemophilia patients is the knee.
AIM


This study evaluates the effectiveness of manual therapy and passive muscle stretching exercises for reducing the frequency of hemarthrosis and pain and improving joint health and range of motion in patients with haemophilic knee arthropathy.
METHODS


Twenty eight patients with haemophilic knee arthropathy were randomized to an experimental group or to a control group (without intervention). Manual therapy sessions included joint traction and gliding manoeuvers, in addition to passive muscle stretching. The intervention included one 60-minute with two weekly sessions over a 12-week period. We evaluated the frequency of knee hemarthrosis (self-reporting), joint health (Hemophilia Joint Health Score), range of motion (goniometry) and perceived knee pain (visual analogue scale). A baseline evaluation was performed at the end of the intervention and after a 12-week follow-up period.
RESULTS


The frequency of hemarthrosis dropped significantly in the experimental group compared to the control group (F = 11.43; P < .001). Compared to the control group, the experimental group had consistently better results in the variables for joint health (F = 13.80; P < .001), range of motion in knee flexion (F = 24.29; P < .001) and loss of extension (F = 8.90; P < .001), and perceived pain (F = 49.73; P < .001).
CONCLUSIONS


Manual therapy using joint traction and gliding manoeuvers, in addition to passive muscle stretching, reduces the frequency of hemarthrosis in patients with haemophilia. Manual therapy with passive muscle stretching exercises improves joint health, range of motion and perceived joint pain.",2020,The frequency of hemarthrosis dropped significantly in the experimental group compared to the control group (F = 11.43; P < .001).,"['patients with haemophilic knee arthropathy', 'haemophilia patients', 'patients with haemophilia', 'Twenty eight patients with haemophilic knee arthropathy']","['passive stretching exercises', 'manual therapy', 'Manual therapy with passive muscle stretching exercises', 'manual therapy and passive muscle stretching exercises', 'control group (without intervention']","['frequency of hemarthrosis and pain and improving joint health and range of motion', 'joint health, range of motion and perceived joint pain', 'frequency of hemarthrosis', 'loss of extension', 'perceived pain', 'joint health', 'frequency of knee hemarthrosis (self-reporting), joint health (Hemophilia Joint Health Score), range of motion (goniometry) and perceived knee pain (visual analogue scale', 'range of motion in knee flexion']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2105246', 'cui_str': 'Knee arthropathy'}, {'cui': 'C0019069', 'cui_str': 'Hereditary factor VIII deficiency disease'}, {'cui': 'C4283787', 'cui_str': '28'}]","[{'cui': 'C1720871', 'cui_str': 'Static-Passive Stretching'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0454525', 'cui_str': 'Manual therapy'}, {'cui': 'C1720868', 'cui_str': 'Muscle Stretching Exercises'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0018924', 'cui_str': 'Hemarthrosis'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0003862', 'cui_str': 'Joint pain'}, {'cui': 'C0439792', 'cui_str': 'Extent'}, {'cui': 'C0343170', 'cui_str': 'Hemarthrosis of knee'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0019069', 'cui_str': 'Hereditary factor VIII deficiency disease'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}]",28.0,0.0289798,The frequency of hemarthrosis dropped significantly in the experimental group compared to the control group (F = 11.43; P < .001).,"[{'ForeName': 'Rubén', 'Initials': 'R', 'LastName': 'Cuesta-Barriuso', 'Affiliation': 'Department of Physiotherapy, Faculty of Sport Sciences, European University of Madrid, Madrid, Spain.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Gómez-Conesa', 'Affiliation': 'Research Group in Physiotherapy and Health Promotion, Regional Campus of International Excellence ""Campus Mare Nostrum"", University of Murcia, Murcia, Spain.'}, {'ForeName': 'José Antonio', 'Initials': 'JA', 'LastName': 'López-Pina', 'Affiliation': 'Department of Basic Phycology and Methodology, University of Murcia, Murcia, Spain.'}]",Haemophilia : the official journal of the World Federation of Hemophilia,['10.1111/hae.14181']
2206,33094909,Cardiopoietic stem cell therapy in ischaemic heart failure: long-term clinical outcomes.,"AIMS


This study aims to explore long-term clinical outcomes of cardiopoiesis-guided stem cell therapy for ischaemic heart failure assessed in the Congestive Heart Failure Cardiopoietic Regenerative Therapy (CHART-1) trial.
METHODS AND RESULTS


CHART-1 is a multinational, randomized, and double-blind trial conducted in 39 centres in heart failure patients (n = 315) on standard-of-care therapy. The 'active' group received cardiopoietic stem cells delivered intramyocardially using a retention-enhanced catheter. The 'control' group underwent patient-level sham procedure. Patients were followed up to 104 weeks. In the entire study population, results of the primary hierarchical composite outcome were maintained neutral at Week 52 [Mann-Whitney estimator 0.52, 95% confidence interval (CI) 0.45-0.59, P = 0.51]. Landmark analyses suggested late clinical benefit in patients with significant left ventricular enlargement receiving adequate dosing. Specifically, beyond 100 days of follow-up, patients with left ventricular end-diastolic volume of 200-370 mL treated with ≤19 injections of cardiopoietic stem cells showed reduced risk of death or cardiovascular hospitalization (hazard ratio 0.38, 95% CI 0.16-0.91, P = 0.031) and cardiovascular death or heart failure hospitalization (hazard ratio 0.28, 95% CI 0.09-0.94, P = 0.040). Cardiopoietic stem cell therapy was well tolerated long term with no difference in safety readouts compared with sham at 2 years.
CONCLUSIONS


Longitudinal follow-up documents that cardiopoietic stem cell therapy is overall safe, and post hoc analyses suggest benefit in an ischaemic heart failure subpopulation defined by advanced left ventricular enlargement on tolerable stem cell dosing. The long-term clinical follow-up thus offers guidance for future targeted trials.",2020,"Cardiopoietic stem cell therapy was well tolerated long term with no difference in safety readouts compared with sham at 2 years.
","['patients with significant left ventricular enlargement receiving adequate dosing', '39 centres in heart failure patients (n\xa0=\xa0315) on standard-of-care therapy', 'ischaemic heart failure']","['Cardiopoietic stem cell therapy', 'cardiopoietic stem cells delivered intramyocardially using a retention-enhanced catheter', 'patient-level sham procedure', 'cardiopoiesis-guided stem cell therapy']","['cardiovascular death or heart failure hospitalization', 'risk of death or cardiovascular hospitalization']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C2675972', 'cui_str': 'Ventricular enlargement'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}]","[{'cui': 'C0872278', 'cui_str': 'Stem cell therapy'}, {'cui': 'C0038250', 'cui_str': 'Stem cell'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0181090', 'cui_str': 'Guide'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",,0.435519,"Cardiopoietic stem cell therapy was well tolerated long term with no difference in safety readouts compared with sham at 2 years.
","[{'ForeName': 'Jozef', 'Initials': 'J', 'LastName': 'Bartunek', 'Affiliation': 'Cardiovascular Center, OLV Hospital, Moorselbaan 164, Aalst, B-9300, Belgium.'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Terzic', 'Affiliation': 'Cardiovascular Center, OLV Hospital, Moorselbaan 164, Aalst, B-9300, Belgium.'}, {'ForeName': 'Beth A', 'Initials': 'BA', 'LastName': 'Davison', 'Affiliation': 'Momentum Research, Inc., Durham, NC, USA.'}, {'ForeName': 'Atta', 'Initials': 'A', 'LastName': 'Behfar', 'Affiliation': 'Department of Cardiovascular Medicine, Mayo Clinic, Center for Regenerative Medicine, 200 First Street SW, Rochester, MN, 55905, USA.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Sanz-Ruiz', 'Affiliation': 'Cardiology Department, Hospital General Universitario Gregorio Marañón and CIBERCV (Instituto de Salud Carlos III), Madrid, Spain.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Wojakowski', 'Affiliation': 'Department of Cardiology and Structural Heart Disease, Medical University of Silesia, Katowice, Poland.'}, {'ForeName': 'Warren', 'Initials': 'W', 'LastName': 'Sherman', 'Affiliation': 'Consultant, South Egremont, MA, USA.'}, {'ForeName': 'Guy R', 'Initials': 'GR', 'LastName': 'Heyndrickx', 'Affiliation': 'Cardiovascular Center, OLV Hospital, Moorselbaan 164, Aalst, B-9300, Belgium.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Metra', 'Affiliation': 'Cardiology, Department of Medical and Surgical Specialties, Radiological Sciences, and Public Health, University and Spedali Civili, Brescia, Italy.'}, {'ForeName': 'Gerasimos S', 'Initials': 'GS', 'LastName': 'Filippatos', 'Affiliation': 'National and Kapodistrian University of Athens, School of Medicine, Attikon University Hospital, Athens, Greece.'}, {'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'Waldman', 'Affiliation': 'Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Teerlink', 'Affiliation': 'School of Medicine, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Timothy D', 'Initials': 'TD', 'LastName': 'Henry', 'Affiliation': 'The Carl Edyth Lindner Center for Research and Education at The Christ Hospital, Cincinnati, OH, USA.'}, {'ForeName': 'Bernard J', 'Initials': 'BJ', 'LastName': 'Gersh', 'Affiliation': 'Department of Cardiovascular Medicine, Mayo Clinic, Center for Regenerative Medicine, 200 First Street SW, Rochester, MN, 55905, USA.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Hajjar', 'Affiliation': 'Phospholamban Foundation, Amsterdam, Netherlands.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Tendera', 'Affiliation': 'Department of Cardiology and Structural Heart Disease, Medical University of Silesia, Katowice, Poland.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Senger', 'Affiliation': 'Momentum Research, Inc., Durham, NC, USA.'}, {'ForeName': 'Gad', 'Initials': 'G', 'LastName': 'Cotter', 'Affiliation': 'Momentum Research, Inc., Durham, NC, USA.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Povsic', 'Affiliation': 'Duke Clinical Research Institute and Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Wijns', 'Affiliation': 'The Lambe Institute for Translational Medicine and Curam, National University of Ireland Galway and Saolta University Healthcare Group, Galway, Ireland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",ESC heart failure,['10.1002/ehf2.13031']
2207,33094919,Overnight fasting before lapatinib administration to breast cancer patients leads to reduced toxicity compared with nighttime dosing: a retrospective cohort study from a randomized clinical trial.,"BACKGROUND


The bioavailability of lapatinib is affected by food, even following the 1 hour fast recommended by the package insert. We hypothesized that overnight fasting would minimize food-drug interactions. Here, we investigated if lapatinib administration timing is associated with its tolerability, efficacy, and pharmacokinetics.
METHODS


This is a retrospective cohort study utilizing the medical records of patients enrolled in the JBCRG-16/Neo-LaTH randomized phase 2 trial for breast cancer patients treated with lapatinib. Lapatinib administration timing was divided into three groups: before breakfast (BB), between meals (BM), and at bedtime (AB). Side effects (SE), treatment discontinuation rate (TDR), relative dose intensity (RDI), pathological complete response (pCR) rate, and lapatinib serum trough concentration were compared between groups.
RESULTS


About 140 patients were included in this study: BB 15, BM 51, and AB 74. A reduced risk of diarrhea {adjusted hazard ratio (HR), 0.51, 95% confidence interval (CI), 0.27-0.89, p = 0.018}, and rash {adjusted HR, 0.37; 95% CI, 0.17-0.70, p = 0.002} was seen in BB versus AB. Fewer patients with low RDI (< 0.85/<0.6) were in the BB group (BB 13% / 0%, BM 22% / 3.9%, AB 24% / 14%, p = 0.70 / 0.11). pCR was not diminished (p = 0.75). BB group had the lowest serum lapatinib concentration and variability (mean ±SD were 0.35 ± 0.15, 0.65 ± 0.32, 0.96 ± 0.43 µg/ml).
CONCLUSIONS


Compared to bedtime administration, lapatinib administration after overnight fasting reduces its toxicity without diminishing its therapeutic efficacy.",2020,"A reduced risk of diarrhea {adjusted hazard ratio (HR), 0.51, 95% confidence interval (CI), 0.27-0.89, p = 0.018}, and rash {adjusted HR, 0.37; 95% CI, 0.17-0.70, p = 0.002} was seen in BB versus AB.","['140 patients were included in this study: BB 15, BM 51, and AB 74', 'breast cancer patients', 'patients enrolled in the JBCRG-16/Neo-LaTH randomized phase 2 trial for breast cancer patients treated with']","['lapatinib', 'Lapatinib']","['pCR', 'risk of diarrhea {adjusted hazard ratio (HR', 'tolerability, efficacy, and pharmacokinetics', 'toxicity', 'Side effects (SE), treatment discontinuation rate (TDR), relative dose intensity (RDI), pathological complete response (pCR) rate, and lapatinib serum trough concentration', 'lowest serum lapatinib concentration and variability']","[{'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1549040', 'cui_str': 'Before breakfast'}, {'cui': 'C0587121', 'cui_str': 'Between meals'}, {'cui': 'C0521112', 'cui_str': 'Bedtime'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C1506770', 'cui_str': 'lapatinib'}]","[{'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C1506770', 'cui_str': 'lapatinib'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",140.0,0.158297,"A reduced risk of diarrhea {adjusted hazard ratio (HR), 0.51, 95% confidence interval (CI), 0.27-0.89, p = 0.018}, and rash {adjusted HR, 0.37; 95% CI, 0.17-0.70, p = 0.002} was seen in BB versus AB.","[{'ForeName': 'Moe', 'Initials': 'M', 'LastName': 'Tsuda', 'Affiliation': 'Department of Breast Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Ishiguro', 'Affiliation': 'Breast Oncology Service, Saitama Medical University International Medical Center, Hidaka, Japan.'}, {'ForeName': 'Naoko', 'Initials': 'N', 'LastName': 'Toriguchi', 'Affiliation': 'Oncology Products, Medicine Development Unit Japan, Eli Lilly Japan K.K, Kobe, Japan.'}, {'ForeName': 'Norikazu', 'Initials': 'N', 'LastName': 'Masuda', 'Affiliation': 'Department of Surgery, Breast Oncology, NHO Osaka National Hospital, Osaka, Japan.'}, {'ForeName': 'Hiroko', 'Initials': 'H', 'LastName': 'Bando', 'Affiliation': 'Breast and Endocrine Surgery, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Ohgami', 'Affiliation': 'Department of Pharmacy, Ibaraki Prefectural Central Hospital, Kasama, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Homma', 'Affiliation': 'Department of Pharmaceutical Sciences, Division of Clinical Medicine, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Morita', 'Affiliation': 'Department of Biomedical Statistics and Bioinformatics. Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Naohito', 'Initials': 'N', 'LastName': 'Yamamoto', 'Affiliation': 'Division of Breast Surgery, Chiba Cancer Center, Chiba, Japan.'}, {'ForeName': 'Katsumasa', 'Initials': 'K', 'LastName': 'Kuroi', 'Affiliation': 'Department of Breast Surgery, Tokyo Metropolitan Health and Hospitals Corporation Ebara Hospital, Tokyo, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Yanagita', 'Affiliation': 'Department of Breast Oncology, Gunma Prefectural Cancer Center, Gunma, Japan.'}, {'ForeName': 'Toshimi', 'Initials': 'T', 'LastName': 'Takano', 'Affiliation': 'Breast Medical Oncology, Breast Oncology Center, The Cancer Institute Hospital of JFCR, Tokyo, Japan.'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Shimizu', 'Affiliation': 'Breast and Endocrine Surgery, Kanagawa Cancer Center, Yokohama, Japan.'}, {'ForeName': 'Masakazu', 'Initials': 'M', 'LastName': 'Toi', 'Affiliation': 'Department of Breast Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}]",Cancer medicine,['10.1002/cam4.3528']
2208,33098189,Do Patients Regret Having Received Systemic Treatment for Advanced Non-Small Cell Lung Cancer: A Prospective Evaluation.,"BACKGROUND


Thousands of patients annually receive treatment for advanced NSCLC, but little is known about their views on the decision to receive that treatment, or regret. This trial prospectively evaluated the incidence of regret and whether baseline characteristics, patient decision-making parameters, or clinical progress early in the treatment course predicts regret.
MATERIALS AND METHODS


Patients receiving systemic treatment for advanced NSCLC completed every 3-week PRO assessment using the electronic LCSS, including the 3-Item Global Index (""3-IGI,"" assessing overall distress, activities, and QL). A prespecified secondary aim was to determine the frequency of regret evaluated at three months after starting treatment. Patients were randomized to usual care, or enhanced care (which included use of the DecisionKEYS decision aid).
RESULTS


Of 164 patients entered, 160 received treatment and 142 were evaluable for regret. In total, 11.5% of patients, and 9% of their supporters expressed regret. Baseline characteristics did not predict regret; regret was rarely expressed by those who had a less than 20% decline or improvement in the 3-IGI PRO score after two treatment cycles. In contrast, when asked if they would make the same decision again, only 1% not having a 20% 3-IGI decline expressed regret, versus 14% with a 3-IGI decline (p=0.01).
CONCLUSION


The majority of patients having regret were identified early using the PRO 3-IGI of the eLCSS-QL measure. Identifying patients at risk for regret allows for interventions, including frank discussions of progress and goals early in the treatment course, which could address regret in patients and their supporters.
IMPLICATIONS FOR PRACTICE


This report documents prospectively for the first time the incidence of treatment-related regret in patients with advanced lung cancer, and outlines that risk of regret is associated with patient-determined worsening health status early in the course of treatment. Identifying patients at risk for regret early in treatment (before the 3rd cycle of treatment) appears to be crucial. Counseling at that time should include a discussion of consideration of treatment change and the reason for this change.",2020,Baseline characteristics did not predict regret; regret was rarely expressed by those who had a less than 20% decline or improvement in the 3-IGI PRO score after two treatment cycles.,"['Patients receiving systemic treatment for advanced NSCLC completed every 3-week PRO assessment using the electronic LCSS, including the 3-Item', '164 patients entered, 160 received treatment and 142 were evaluable for regret', 'patients with advanced lung cancer']","['Systemic Treatment', 'usual care, or enhanced care (which included use of the DecisionKEYS decision aid']","['3-IGI PRO score', 'Global Index (""3-IGI,"" assessing overall distress, activities, and QL', 'frequency of regret']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0585333', 'cui_str': 'Triweekly'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0080101', 'cui_str': 'Regret'}, {'cui': 'C4524268', 'cui_str': 'Advanced lung cancer'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0086104', 'cui_str': 'Decision Aids'}]","[{'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0080101', 'cui_str': 'Regret'}]",164.0,0.0411787,Baseline characteristics did not predict regret; regret was rarely expressed by those who had a less than 20% decline or improvement in the 3-IGI PRO score after two treatment cycles.,"[{'ForeName': 'Patricia J', 'Initials': 'PJ', 'LastName': 'Hollen', 'Affiliation': 'University of Virginia, Charlottesville, VA.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Gralla', 'Affiliation': 'Albert Einstein College of Medicine, Bronx, NY.'}, {'ForeName': 'Ryan D', 'Initials': 'RD', 'LastName': 'Gentzler', 'Affiliation': 'University of Virginia, Charlottesville, VA.'}, {'ForeName': 'Richard D', 'Initials': 'RD', 'LastName': 'Hall', 'Affiliation': 'University of Virginia, Charlottesville, VA.'}, {'ForeName': 'Bethany', 'Initials': 'B', 'LastName': 'Coyne', 'Affiliation': 'University of Virginia, Charlottesville, VA.'}, {'ForeName': 'Haiying', 'Initials': 'H', 'LastName': 'Cheng', 'Affiliation': 'Albert Einstein College of Medicine, Bronx, NY.'}, {'ForeName': 'Balazs', 'Initials': 'B', 'LastName': 'Halmos', 'Affiliation': 'Albert Einstein College of Medicine, Bronx, NY.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Gildersleeve', 'Affiliation': 'University of Virginia, Charlottesville, VA.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Calderon', 'Affiliation': 'Albert Einstein College of Medicine, Bronx, NY.'}, {'ForeName': 'Ivora', 'Initials': 'I', 'LastName': 'Hinton', 'Affiliation': 'University of Virginia, Charlottesville, VA.'}, {'ForeName': 'Geoffrey', 'Initials': 'G', 'LastName': 'Weiss', 'Affiliation': 'University of Virginia, Charlottesville, VA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Crawford', 'Affiliation': 'Duke University, Durham, NC.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Cerise', 'Affiliation': 'Feinstein Institute for Medical Research, Manhasset, NY.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Lesser', 'Affiliation': 'Feinstein Institute for Medical Research, Manhasset, NY.'}]",The oncologist,['10.1002/onco.13571']
2209,33098212,Timing of CGM Initiation in Pediatric Diabetes - The CGM TIME Trial.,"OBJECTIVE


To determine whether timing of CGM initiation offering low glucose suspend (LGS) affects CGM adherence in children and youth starting insulin pump therapy.
METHODS


A 5-site RCT of pump-naïve subjects (aged 5-18 years) with type 1 diabetes (T1D) for at least 1 year compared simultaneous pump and CGM initiation offering LGS vs. standard pump therapy with CGM initiation delayed for 6 months. Primary outcome was CGM adherence (hours per 28 days) (MiniMed™ Paradigm™ Veo™ system; CareLink™ Pro software) over 6 months after CGM initiation. Secondary outcome HbA1c was measured centrally. Linear mixed-models and ordinary least squares models were fitted to estimate effect of intervention, and covariates baseline age, T1D duration, HbA1c, gender, ethnicity, hypoglycemia history, clinical site, and association between CGM adherence and HbA1c.
RESULTS


The trial randomized 144/152 (95%) eligible subjects. Baseline mean age was 11.5±3.3(SD) years, T1D duration 3.4±3.1 years, and HbA1c 7.9±0.9%. Six months after CGM initiation, adjusted mean difference in CGM adherence was 62.4 hours per 28 days greater in the Simultaneous Group compared to Delayed Group (p=0.007). There was no difference in mean HbA1c at 6 months. However, for each 100 hours of CGM use per 28-day period, HbA1c was 0.39% (95% CI 0.10% to 0.69%) lower. Higher CGM adherence was associated with reduced time with glucose >10 mmol/L (p<0.001).
CONCLUSION


CGM adherence was higher after 6 months when initiated at same time as pump therapy compared to starting CGM 6 months after pump therapy. Greater CGM adherence was associated with improved HbA1c. This article is protected by copyright. All rights reserved.",2020,"Higher CGM adherence was associated with reduced time with glucose >10 mmol/L (p<0.001).
","['children and youth starting insulin pump therapy', 'A 5-site RCT of pump-naïve subjects (aged 5-18\u2009years) with type 1 diabetes (T1D) for at least 1 year compared']","['CGM initiation offering low glucose suspend (LGS', 'simultaneous pump and CGM initiation offering LGS vs. standard pump therapy with CGM initiation delayed for 6 months']","['Higher CGM adherence', 'Greater CGM adherence', 'CGM adherence (hours per 28\u2009days) (MiniMed™ Paradigm™ Veo™ system; CareLink™ Pro software', 'CGM adherence']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C1140609', 'cui_str': 'Insulin pump'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011854', 'cui_str': 'Type 1 diabetes mellitus'}]","[{'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0860801', 'cui_str': 'Glucose low'}, {'cui': 'C0038959', 'cui_str': 'Suspending Agents'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0564385', 'cui_str': '/hour'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0037585', 'cui_str': 'Software'}]",,0.218352,"Higher CGM adherence was associated with reduced time with glucose >10 mmol/L (p<0.001).
","[{'ForeName': 'Margaret L', 'Initials': 'ML', 'LastName': 'Lawson', 'Affiliation': ""Children's Hospital of Eastern Ontario, CHEO Research Institute.""}, {'ForeName': 'Kate C', 'Initials': 'KC', 'LastName': 'Verbeeten', 'Affiliation': ""Children's Hospital of Eastern Ontario, CHEO Research Institute.""}, {'ForeName': 'Jennilea M', 'Initials': 'JM', 'LastName': 'Courtney', 'Affiliation': 'CHEO Research Institute.'}, {'ForeName': 'Brenda J', 'Initials': 'BJ', 'LastName': 'Bradley', 'Affiliation': 'CHEO Research Institute.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'McAssey', 'Affiliation': ""McMaster Children's Hospital.""}, {'ForeName': 'Cheril', 'Initials': 'C', 'LastName': 'Clarson', 'Affiliation': ""Children's Hospital, London Health Sciences Centre, Lawson Health Research Institute.""}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Kirsch', 'Affiliation': 'Markham-Stouffville Hospital.'}, {'ForeName': 'Jacqueline R', 'Initials': 'JR', 'LastName': 'Curtis', 'Affiliation': 'Hospital for Sick Childrene.'}, {'ForeName': 'Farid H', 'Initials': 'FH', 'LastName': 'Mahmud', 'Affiliation': 'Hospital for Sick Childrene.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Richardson', 'Affiliation': ""Children's Hospital of Eastern Ontario.""}, {'ForeName': 'Tammy', 'Initials': 'T', 'LastName': 'Cooper', 'Affiliation': ""Children's Hospital of Eastern Ontario.""}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Chan', 'Affiliation': 'CHEO Research Institute.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Tang', 'Affiliation': 'CHEO Research Institute.'}]",Pediatric diabetes,['10.1111/pedi.13144']
2210,33098276,Interaction of Treatment Intensity and Autism Severity on Frequency and Maturity of Spontaneous Communication in Toddlers with Autism Spectrum Disorder.,"This study tested whether the effect of treatment intensity or treatment style on children's frequency and maturity of spontaneous communication varied by initial severity of disability. Eighty-seven toddlers with autism spectrum disorders were randomly assigned to either (a) 15 hrs per week of discrete trial teaching (DTT), (b) 25 hrs per week of DTT, (c) 15 hrs per week of a naturalistic developmental behavioral intervention (NDBI), or (d) 25 hrs per week of NDBI. Trained research staff implemented the 1:1 treatments in homes or educational centers over 12 months. We quantified the frequency and maturity of spontaneous communication during monthly 6-min communication samples. We quantified disability severity at Time 1 using the developmental quotient from the Mullen Scales of Early Learning and the total calibrated severity score from the Autism Diagnostic Observation Schedule-second edition. Higher levels of treatment intensity (i.e., more hours per week) benefited frequency and maturity of spontaneous communication growth rate only in children with relatively mild autism symptoms. Other results were nonsignificant. LAY SUMMARY: Eighty-seven toddlers with autism spectrum disorders were randomly assigned to 15 hrs per week of discrete trial teaching (DTT), 25 hrs per week of DTT, 15 hrs per week of a naturalistic developmental behavioral intervention (NDBI), or 25 hrs per week of NDBI. Trained research staff implemented the treatments in homes or educational centers over 12 months. More hours of treatment per week benefited frequency and maturity of spontaneous communication growth rate only in children with relatively mild autism symptoms. Other results were nonsignificant.",2020,More hours of treatment per week benefited frequency and maturity of spontaneous communication growth rate only in children with relatively mild autism symptoms.,"['Eighty-seven toddlers with autism spectrum disorders', 'children with relatively mild autism symptoms', 'Toddlers with Autism Spectrum Disorder', 'homes or educational centers over 12\u2009months', ' Eighty-seven toddlers with autism spectrum disorders']","['naturalistic developmental behavioral intervention (NDBI), or', 'naturalistic developmental behavioral intervention (NDBI), or 25\u2009hrs per week of NDBI']",[],"[{'cui': 'C4517895', 'cui_str': '87'}, {'cui': 'C0682053', 'cui_str': 'Toddler'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0458003', 'cui_str': 'Developmental'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}]",[],87.0,0.0381974,More hours of treatment per week benefited frequency and maturity of spontaneous communication growth rate only in children with relatively mild autism symptoms.,"[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Yoder', 'Affiliation': 'Vanderbilt University, Special Education, Nashville, Tennessee, USA.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Rogers', 'Affiliation': 'University of California, Davis MIND Institute, Berkeley, California, USA.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Estes', 'Affiliation': 'University of Washington, UW Autism Center, Seattle, Washington, USA.'}, {'ForeName': 'Zachary', 'Initials': 'Z', 'LastName': 'Warren', 'Affiliation': 'Vanderbilt University, Special Education, Nashville, Tennessee, USA.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Munson', 'Affiliation': 'University of Washington, UW Autism Center, Seattle, Washington, USA.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Hellemann', 'Affiliation': 'Department of Biostatistics, University California, Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'McEachin', 'Affiliation': 'Huntington Beach, California, USA.'}]",Autism research : official journal of the International Society for Autism Research,['10.1002/aur.2416']
2211,33098278,Counselor Surveillance of Digital Self-Monitoring Data: A Pilot Randomized Controlled Trial.,"OBJECTIVE


This pilot study tested counselor access to participants' digital self-monitoring (SM) data as a means of improving long-term lifestyle modification (LM) outcomes.
METHODS


After 12 weeks of weight-loss treatment, participants (N = 77) were randomized to LM or LM+SHARE for weeks 13 to 52. All participants received monthly phone calls and weekly text messages from weeks 13 to 52 and were instructed to engage in daily digital SM of weight, eating, and exercise. In LM+SHARE, but not LM, counselors had access to SM device data. Assessments were conducted as weeks 0, 13, 26, and 52.
RESULTS


Retention, engagement, and treatment satisfaction were excellent. LM+SHARE participants, compared with LM, had more frequent SM of weight and eating. Weight loss continued at a similar rate in both conditions from weeks 13 to 26. From weeks 26 to 52, those in LM regained approximately 2 kg, whereas those in LM+SHARE maintained weight loss, a significant difference. Nonetheless, total weight loss did not significantly differ by condition. Engagement in dietary SM mediated the effect of condition on weight.
CONCLUSIONS


Counselor access to SM data is feasible and acceptable. Additional research is warranted to determine whether it can meaningfully improve outcomes.",2020,"Nonetheless, total weight loss did not significantly differ by condition.","['participants (N\u2009=\u200977', 'participants']","['Digital Self-Monitoring Data', 'monthly phone calls and weekly text messages from weeks 13 to 52 and were instructed to engage in daily digital SM of weight, eating, and exercise', 'digital self-monitoring (SM) data', 'LM or LM+SHARE']","['Retention, engagement, and treatment satisfaction', 'frequent SM of weight and eating', 'Weight loss', 'total weight loss']",[],"[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]","[{'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",77.0,0.0682005,"Nonetheless, total weight loss did not significantly differ by condition.","[{'ForeName': 'Meghan L', 'Initials': 'ML', 'LastName': 'Butryn', 'Affiliation': 'Department of Psychology and WELL Center, Drexel University, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Mary K', 'Initials': 'MK', 'LastName': 'Martinelli', 'Affiliation': 'Department of Psychology and WELL Center, Drexel University, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Nicole T', 'Initials': 'NT', 'LastName': 'Crane', 'Affiliation': 'Department of Psychology and WELL Center, Drexel University, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Godfrey', 'Affiliation': 'Department of Psychology and WELL Center, Drexel University, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Savannah R', 'Initials': 'SR', 'LastName': 'Roberts', 'Affiliation': 'Department of Psychology and WELL Center, Drexel University, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Fengqing', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': 'Department of Psychology and WELL Center, Drexel University, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Evan M', 'Initials': 'EM', 'LastName': 'Forman', 'Affiliation': 'Department of Psychology and WELL Center, Drexel University, Philadelphia, Pennsylvania, USA.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.23015']
2212,33098463,Caffeine ingestion alters central hemodynamics following aerobic exercise in middle-aged men.,"PURPOSE


To examine the acute influence of caffeine on post-exercise central blood pressures, arterial stiffness, and wave reflection properties.
METHODS


In a double-blind randomized placebo-controlled crossover study design, ten middle-aged males (55 ± 5 year) completed two exercise trials after ingestion of caffeine (400 mg) or placebo. Measurements were taken before and 30 min post-ingestion via cuff-based pulse wave analysis (PWA) and carotid-femoral pulse wave velocity (PWV). Participants performed a 40-min cycling bout at 70% HRmax with matched workloads between trials. PWA and PWV were reassessed 30 min post-exercise.
RESULTS


Prior to exercise, compared to placebo, caffeine increased brachial systolic blood pressure (bSBP) (+ 12.3 ± 2.4 mmHg; p = 0.004), brachial diastolic blood pressure (bDBP) (+ 7.7 ± 0.9 mmHg; p = 0.011), central systolic blood pressure (cSBP) (+ 11.1 ± 2.1 mmHg; p = 0.005) and central diastolic blood pressure (cDBP) (+ 7.6 ± 1.0 mmHg; p = 0.012). PWV was higher 30 min after pill ingestion (p = 0.021 for time) with a trend for a greater increase in caffeine (p = 0.074 for interaction). bSBP (p = 0.036) and cSBP (p = 0.007) were lower after exercise but remained higher (both p < 0.001) in caffeine compared to placebo. PWV remained higher (p = 0.023) after exercise in caffeine compared to placebo but was not influenced by exercise. At rest, augmentation pressure (AP) and index (AIx) were not influenced by caffeine ingestion. Conversely, AIx was lower (p = 0.009) after exercise in placebo only.
CONCLUSION


In healthy and active middle-aged men, pre-exercise caffeine ingestion led to higher central and peripheral systolic blood pressures, PWV and AIx at 30 min post-exercise, indicating an increased left ventricular workload which may have implications for cardiovascular event risk.",2020,PWV remained higher (p = 0.023) after exercise in caffeine compared to placebo but was not influenced by exercise.,"['In healthy and active middle-aged men', 'ten middle-aged males (55\u2009±\u20095\xa0year) completed two', 'middle-aged men']","['caffeine', 'exercise trials after ingestion of caffeine', 'placebo', 'aerobic exercise', 'Caffeine ingestion', 'placebo, caffeine']","['central diastolic blood pressure (cDBP', 'central systolic blood pressure (cSBP', 'bSBP', 'brachial systolic blood pressure (bSBP', 'central and peripheral systolic blood pressures, PWV and AIx', 'augmentation pressure (AP) and index (AIx', 'cSBP', 'central hemodynamics', 'brachial diastolic blood pressure (bDBP', 'post-exercise central blood pressures, arterial stiffness, and wave reflection properties', 'PWV', 'PWA and PWV']","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}]","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0445456', 'cui_str': 'Brachial'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0871161', 'cui_str': 'Property'}, {'cui': 'C3494430', 'cui_str': 'Pulse Wave Analysis'}]",,0.378982,PWV remained higher (p = 0.023) after exercise in caffeine compared to placebo but was not influenced by exercise.,"[{'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Harber', 'Affiliation': 'Clinical Exercise Physiology, Human Performance Laboratory, Ball State University, Muncie, IN, 47306, USA. mharber@bsu.edu.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'McCurry', 'Affiliation': 'Clinical Exercise Physiology, Human Performance Laboratory, Ball State University, Muncie, IN, 47306, USA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Carlini', 'Affiliation': 'Clinical Exercise Physiology, Human Performance Laboratory, Ball State University, Muncie, IN, 47306, USA.'}, {'ForeName': 'Brandon', 'Initials': 'B', 'LastName': 'Kistler', 'Affiliation': 'Nutrition and Dietetics, Ball State University, Muncie, IN, USA.'}, {'ForeName': 'Bradley S', 'Initials': 'BS', 'LastName': 'Fleenor', 'Affiliation': 'Clinical Exercise Physiology, Human Performance Laboratory, Ball State University, Muncie, IN, 47306, USA.'}]",European journal of applied physiology,['10.1007/s00421-020-04521-3']
2213,33094958,Empiric Versus Clarithromycin Resistance-Guided Therapy for Helicobacter pylori Based on Polymerase Chain Reaction Results in Patients With Gastric Neoplasms or Gastric Mucosa-Associated Lymphoid Tissue Lymphoma: A Randomized Controlled Trial.,"INTRODUCTION


We investigated to compare the effect of empirical therapy vs clarithromycin resistance-guided tailored therapy (tailored therapy) for eradication of Helicobacter pylori.
METHODS


In this prospective, single center, open-label randomized controlled trial, we enrolled 72 patients with H. pylori infection from January 2019 through June 2019 in Korea. The patients were randomly assigned to both groups received empirical (n = 36) or tailored therapy (n = 36). Empirical therapy was defined as triple therapy with esomeprazole, amoxicillin, and clarithromycin for 10 days irrespective of clarithromycin resistance. Tailored therapy was triple or quadruple therapy with esomeprazole, metronidazole, tetracycline, and bismuth for 10 days based on genotype markers of resistance determined by gastric biopsy. Resistance-associated mutations in 23S rRNA were confirmed by multiplex polymerase chain reaction. Eradication status was assessed by C-urea breath test, and the primary outcome was eradication rates.
RESULTS


H. pylori was eradicated in 27 patients (75.0%), given empirical therapy and 32 patients (88.9%) treated with tailored therapy (P = 0.136) in intention-to-treat analysis. In per protocol analysis, the eradication rate was 97.0% and 81.8% in tailoredvs empirical groups (P = 0.046). Although clarithromycin-resistant H. pylori was eradicated in 3/9 (33.3%) with empirical therapy, it was treated in 11/12 (91.7%) with tailored therapy (P = 0.009). There was no difference in compliance between 2 groups. The rate of adverse events of the tailored group was higher than that of the empirical group (P = 0.036) because quadruple therapy had more side effects than those of triple therapy (P = 0.001).
DISCUSSION


Tailored therapy based on polymerase chain reaction is a good alternative to increase eradication rates in a region of high prevalence of clarithromycin resistance (see Visual Abstract, Supplementary Digital Content 1, http://links.lww.com/CTG/A342).",2020,"The rate of adverse events of the tailored group was higher than that of the empirical group (P = 0.036) because quadruple therapy had more side effects than those of triple therapy (P = 0.001).
","['72 patients with H. pylori infection from January 2019 through June 2019 in Korea', 'Patients With Gastric Neoplasms or Gastric Mucosa-Associated Lymphoid Tissue Lymphoma']","['tailored therapy', 'clarithromycin resistance-guided tailored therapy (tailored therapy', 'esomeprazole, amoxicillin, and clarithromycin', 'Clarithromycin Resistance-Guided Therapy', 'clarithromycin', 'esomeprazole, metronidazole, tetracycline, and bismuth']","['eradication rates', 'eradication rate', 'Eradication status', 'side effects', 'rate of adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0850666', 'cui_str': 'Infection caused by Helicobacter pylori'}, {'cui': 'C0022771', 'cui_str': 'Korea'}, {'cui': 'C0038356', 'cui_str': 'Neoplasm of stomach'}, {'cui': 'C0017136', 'cui_str': 'Gastric mucous membrane structure'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0024296', 'cui_str': 'Lymphatic tissue'}, {'cui': 'C0024299', 'cui_str': 'Malignant lymphoma'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0055856', 'cui_str': 'Clarithromycin'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0937846', 'cui_str': 'Esomeprazole'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C0039644', 'cui_str': 'Tetracycline'}, {'cui': 'C0005642', 'cui_str': 'Bismuth'}]","[{'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",72.0,0.0514967,"The rate of adverse events of the tailored group was higher than that of the empirical group (P = 0.036) because quadruple therapy had more side effects than those of triple therapy (P = 0.001).
","[{'ForeName': 'Jue Lie', 'Initials': 'JL', 'LastName': 'Kim', 'Affiliation': '1Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, South Korea; 2Department of Internal Medicine, Seoul National University Hospital Healthcare System Gangnam Center, Seoul, South Korea.'}, {'ForeName': 'Soo-Jeong', 'Initials': 'SJ', 'LastName': 'Cho', 'Affiliation': ''}, {'ForeName': 'Su Jin', 'Initials': 'SJ', 'LastName': 'Chung', 'Affiliation': ''}, {'ForeName': 'Ayoung', 'Initials': 'A', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Jinju', 'Initials': 'J', 'LastName': 'Choi', 'Affiliation': ''}, {'ForeName': 'Hyunsoo', 'Initials': 'H', 'LastName': 'Chung', 'Affiliation': ''}, {'ForeName': 'Sang Gyun', 'Initials': 'SG', 'LastName': 'Kim', 'Affiliation': ''}]",Clinical and translational gastroenterology,['10.14309/ctg.0000000000000194']
2214,33094961,A Preclinical Animal Study of Combined Intragastric Balloon and Duodenal-Jejunal Bypass Liner for Obesity and Metabolic Disease.,"INTRODUCTION


Endoscopic bariatric and metabolic therapies can potentially reproduce similar gastric and small intestinal anatomic and physiologic manipulations as Roux-en-Y gastric bypass. This proof of concept animal study was aimed to assess the feasibility, safety, efficacy, and impact on gastrointestinal physiology of combined intragastric balloons (IGB) and duodenal-jejunal bypass liner (DJBL) for the treatment of obesity.
METHODS


Five Ossabaw pigs were fed a high-calorie diet to develop obesity and were randomly assigned to receive IGB or DJBL in sequence. The weight gain rate was calculated. Fasting and postprandial blood samples were drawn before any intervention (serving as the baseline group) and 1 month after second device insertion (serving as the combination group) to measure gut neurohormonal changes and metabolic parameters.
RESULTS


Four pigs successfully received a sequential device insertion. One pig developed duodenal sleeve prolapse that was spontaneously resolved. One pig was early terminated because of developing a central line infection. The rate of weight gain in the combination group (0.63 ± 1.3 kg/wk) was significantly lower than the baseline group (1.96 ± 2.17 kg/wk) and numerically lower than after insertion of the IGB (1.00 ± 1.40 kg/wk) or the DJBL (0.75 ± 2.27 kg/wk) alone. A trend of higher postprandial glucagon-like peptide-1 was observed in the combination group compared with the baseline group.
DISCUSSION


A combination of IGB and DJBL is feasible and well tolerated. A strategy of sequential use of these devices might offer a synergistic approach that can enhance weight loss and metabolic outcomes.",2020,The rate of weight gain in the combination group (0.63 ± 1.3 kg/wk) was significantly lower than the baseline group (1.96 ± 2.17 kg/wk) and numerically lower than after insertion of the IGB (1.00 ± 1.40 kg/wk) or the DJBL (0.75 ± 2.27 kg/wk) alone.,['Five Ossabaw pigs were fed a high-calorie diet to develop obesity'],"['combined intragastric balloons (IGB) and duodenal-jejunal bypass liner (DJBL', 'IGB or DJBL', 'Combined Intragastric Balloon and Duodenal-Jejunal Bypass Liner', 'sequential device insertion', 'IGB and DJBL']","['weight gain rate', 'duodenal sleeve prolapse', 'rate of weight gain', 'feasibility, safety, efficacy', 'Fasting and postprandial blood samples', 'higher postprandial glucagon-like peptide-1', 'weight loss and metabolic outcomes']","[{'cui': 'C0039005', 'cui_str': 'Suidae'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0301590', 'cui_str': 'Increased calorie diet'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0442113', 'cui_str': 'Intragastric'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C3880361', 'cui_str': 'Duodenal-jejunal bypass liner'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0013303', 'cui_str': 'Duodenal'}, {'cui': 'C0183336', 'cui_str': 'Sleeve'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.0340945,The rate of weight gain in the combination group (0.63 ± 1.3 kg/wk) was significantly lower than the baseline group (1.96 ± 2.17 kg/wk) and numerically lower than after insertion of the IGB (1.00 ± 1.40 kg/wk) or the DJBL (0.75 ± 2.27 kg/wk) alone.,"[{'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Ghoz', 'Affiliation': '1Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester Minnesota, USA; 2Division of Gastroenterology and Hepatology, Mayo Clinic, Jacksonville, Florida, USA.'}, {'ForeName': 'Veeravich', 'Initials': 'V', 'LastName': 'Jaruvongvanich', 'Affiliation': ''}, {'ForeName': 'Reem', 'Initials': 'R', 'LastName': 'Matar', 'Affiliation': ''}, {'ForeName': 'Azizullah', 'Initials': 'A', 'LastName': 'Beran', 'Affiliation': ''}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Maselli', 'Affiliation': ''}, {'ForeName': 'Andrew C', 'Initials': 'AC', 'LastName': 'Storm', 'Affiliation': ''}, {'ForeName': 'Barham K', 'Initials': 'BK', 'LastName': 'Abu Dayyeh', 'Affiliation': ''}]",Clinical and translational gastroenterology,['10.14309/ctg.0000000000000234']
2215,33095139,Ianalumab (VAY736) in primary Sjögren's syndrome: assessing disease activity using multi-modal ultrasound.,"OBJECTIVES


To apply serial ultrasound (US) assessments to show effects of ianalumab (anti-BAFF-R monoclonal antibody) on inflamed salivary glands of patients with primary Sjögren's syndrome (pSS).
METHODS


In a single-centre, 24-week double-blind study (NCT02149420), 27 pSS patients of moderate-to-severe activity were randomly assigned to receive a single i.v. dose of either 3 mg/kg or 10 mg/kg ianalumab, or placebo. Concurrent with clinical and laboratory outcomes, multi-modal US images were acquired of bilateral parotid glands (PG) and submandibular glands (SMG) at weeks 0, 6, 12, and 24. Applied US modalities included 1) B-mode echostructure scored by de Vita classification, 2) macrovascular blood flow by power Doppler, and in PG only 3) microvascularisation using contrast-enhanced US (area under the curve, time to peak or TTP) and 4) gland stiffness by sonoelastography.
RESULTS


Clinical study results were previously published. US data for PG differed from SMG but were comparable between respective left and right sides of these glands. Numerical improvements in salivary gland quality and declining tissue inflammation were observed in treated versus placebo groups, including more patients achieving ≥1-point reduction from baseline in De Vita score, together with trends towards decreased perfusion and stiffness. Correlations between clinical endpoints and US parameters were largely restricted to microvascular perfusion TTP and at the 12-week timepoint when ianalumab effects were predicted at maximal.
CONCLUSIONS


Early in vivo signs of salivary gland improvement in response to an effective intervention can be shown without need of biopsy by using a non-invasive, comprehensive, ultrasound-based approach over multiple time points.",2020,"Numerical improvements in salivary gland quality and declining tissue inflammation were observed in treated versus placebo groups, including more patients achieving ≥1-point reduction from baseline in De Vita score, together with trends towards decreased perfusion and stiffness.","[""primary Sjögren's syndrome"", '27 pSS patients of moderate-to-severe activity', ""patients with primary Sjögren's syndrome (pSS""]","['ianalumab (anti-BAFF-R monoclonal antibody', 'placebo']",['salivary gland quality and declining tissue inflammation'],"[{'cui': 'C0151449', 'cui_str': ""Primary Sjögren's syndrome""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]","[{'cui': 'C1384654', 'cui_str': 'TNFRSF13C protein, human'}, {'cui': 'C0003250', 'cui_str': 'Monoclonal antibody'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036098', 'cui_str': 'Salivary gland structure'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",27.0,0.0993281,"Numerical improvements in salivary gland quality and declining tissue inflammation were observed in treated versus placebo groups, including more patients achieving ≥1-point reduction from baseline in De Vita score, together with trends towards decreased perfusion and stiffness.","[{'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Diekhoff', 'Affiliation': 'Institute for Radiology, Charité University Hospital, Berlin, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Fischer', 'Affiliation': 'Institute for Radiology, Charité University Hospital, Berlin, Germany.'}, {'ForeName': 'Quirino', 'Initials': 'Q', 'LastName': 'Schefer', 'Affiliation': 'Charité Research Organisation, Berlin, Germany.'}, {'ForeName': 'Maximilian Georg', 'Initials': 'MG', 'LastName': 'Posch', 'Affiliation': 'Charité Research Organisation, Berlin, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Dörner', 'Affiliation': 'Department of Medicine/Rheumatology and Clinical Immunology, Charité University Hospital, Berlin, Germany.'}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Laurent', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Frank D', 'Initials': 'FD', 'LastName': 'Wagner', 'Affiliation': 'Charité Research Organisation, Berlin, Germany.'}, {'ForeName': 'Stephen John', 'Initials': 'SJ', 'LastName': 'Oliver', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland. stephen.oliver@novartis.com.'}]",Clinical and experimental rheumatology,[]
2216,33095180,Therapist-Supported Online Interventions for Children and Young People With Tic Disorders: Lessons Learned From a Randomized Controlled Trial and Considerations for Future Practice.,"In recent years, research into internet-based cognitive behavioral therapy (iCBT) has suggested that therapist-guided digital interventions have greater engagement, adherence, and effectiveness than self-directed digital therapies. While research has focused on the effectiveness of, and adherence to, these interventions, less attention has been paid to their implementation in practice and what aspects of the therapist role support success. An understanding of the key factors related to the therapist role and intervention delivery is required if these iCBTs are to be applied in routine clinical care and outcomes optimized. In light of the coronavirus disease 2019 (COVID-19) pandemic, there is greater emphasis on allowing patients access to remote therapies. We report the experiences and reflections of 4 therapists and their 2 supervisors in delivering an online, therapist-supported intervention in a randomized controlled trial for children and young people with tic disorders (the Online Remote Behavioural Intervention for Tics [ORBIT] trial). Themes discussed include the importance of training, supervision, creating support documents/manuals, and record keeping. Alongside this are communication strategies used by therapists to encourage patient adherence and treatment effectiveness. These include rapport building, treatment personalization, and suggestions for overcoming non-engagement. These reflections offer important considerations for the delivery of iCBTs as well as implications associated with the implementation of these interventions in existing services and future research studies. We share thoughts on where iCBTs may sit in a stepped care model, how services may deal with comorbid conditions, and the potential role of iCBTs in collecting clinical data.",2020,An understanding of the key factors related to the therapist role and intervention delivery is required if these iCBTs are to be applied in routine clinical care and outcomes optimized.,"['With Tic Disorders', 'children and young people with tic disorders (the Online Remote Behavioural Intervention for Tics [ORBIT] trial', 'Children and Young People']","['Therapist-Supported Online Interventions', 'internet-based cognitive behavioral therapy (iCBT', '4 therapists and their 2 supervisors in delivering an online, therapist-supported intervention']",[],"[{'cui': 'C0040188', 'cui_str': 'Tic disorder'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C3898714', 'cui_str': 'Internet Intervention'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0403172', 'cui_str': 'Supervisor'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.052188,An understanding of the key factors related to the therapist role and intervention delivery is required if these iCBTs are to be applied in routine clinical care and outcomes optimized.,"[{'ForeName': 'Liam R', 'Initials': 'LR', 'LastName': 'Chamberlain', 'Affiliation': 'NIHR MindTech Medtech Co-operative, Institute of Mental Health, University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Charlotte L', 'Initials': 'CL', 'LastName': 'Hall', 'Affiliation': 'NIHR MindTech Medtech Co-operative, Institute of Mental Health, University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Andrén', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'E Bethan', 'Initials': 'EB', 'LastName': 'Davies', 'Affiliation': 'NIHR MindTech Medtech Co-operative, Institute of Mental Health, University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Kilgariff', 'Affiliation': 'Nottinghamshire Healthcare NHS Foundation Trust, Nottingham, United Kingdom.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Kouzoupi', 'Affiliation': 'UCL Great Ormond Street Institute of Child Health, University College London, London, United Kingdom.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Murphy', 'Affiliation': 'UCL Great Ormond Street Institute of Child Health, University College London, London, United Kingdom.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Hollis', 'Affiliation': 'NIHR MindTech Medtech Co-operative, Institute of Mental Health, University of Nottingham, Nottingham, United Kingdom.'}]",JMIR mental health,['10.2196/19600']
2217,33095184,Mobile Social Network-Based Smoking Cessation Intervention for Chinese Male Smokers: Pilot Randomized Controlled Trial.,"BACKGROUND


Around 2 million Chinese people, mostly men, die annually from tobacco-related diseases; yet, fewer than 8% of Chinese smokers ever receive any smoking cessation support.
OBJECTIVE


This study aimed to test the preliminary effectiveness and feasibility for a mobile social network (WeChat)-based smoking cessation intervention (SCAMPI program) among Chinese male smokers.
METHODS


Chinese male smokers aged 25-44 years were recruited online from WeChat, the most widely used social media platform in China. Individuals using other smoking cessation interventions or who lacked capacity to provide online informed consent were excluded. Participants were randomly assigned (1:1) to intervention or control groups. Neither participants nor researchers were masked to assignment. The trial was fully online. All data were collected via WeChat. The intervention group received access to the full-version SCAMPI program, a Chinese-language smoking cessation program based on the Behaviour Change Wheel framework and relevant cessation guidelines. Specific intervention functions used in the program include: planning to help users make quitting plans, calculator to record quitting benefits, calendar to record progress, gamification to facilitate quitting, information about smoking harms, motivational messages to help users overcome urges, standardized tests for users to assess their levels of nicotine dependence and lung health, as well as a social platform to encourage social support between users. The control group had access to a static WeChat page of contacts for standard smoking cessation care. Both groups received incentive credit payments for participating. The primary outcome was 30-day biochemically verified smoking abstinence at 6 weeks after randomization, with missing data treated as not quitting. Secondary outcomes were other smoking status measures, reduction of cigarette consumption, study feasibility (recruitment and retention rate), and acceptability of and satisfaction with the program.
RESULTS


The program recorded 5736 visitors over a 13-day recruitment period. We recruited 80 participants who were randomly allocated to two arms (n=40 per arm). At 6 weeks, 36 of 40 (90%) intervention participants and 35 of 40 (88%) control participants provided complete self-reported data on their daily smoking status via WeChat. Biochemically verified smoking abstinence at 6 weeks was determined for 10 of 40 (25%) intervention participants and 2 of 40 (5%) control participants (RR=5, 95% CI 1.2-21.4, P=.03). In the intervention group, the calculator function, motivational messages, and health tests were underused (less than once per week per users). Participants rated their satisfaction with the intervention program as 4.56 out of 5.00.
CONCLUSIONS


Our program is a novel, accessible, and acceptable smoking cessation intervention for Chinese male smokers. A future trial with a greater sample size and longer follow-up will identify if it is as effective as these preliminary data suggest.
TRIAL REGISTRATION


ANZCTR registry, ACTRN12618001089224; https://tinyurl.com/y536n7sx.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


RR2-18071.",2020,"At 6 weeks, 36 of 40 (90%) intervention participants and 35 of 40 (88%) control participants provided complete self-reported data on their daily smoking status via WeChat.","['Chinese male smokers', '80 participants who were randomly allocated to two arms (n=40 per arm', 'Chinese male smokers aged 25-44 years', 'Chinese Male Smokers']","['smoking cessation interventions', 'Mobile Social Network-Based Smoking Cessation Intervention', 'incentive credit payments', 'access to the full-version SCAMPI program, a Chinese-language smoking cessation program based on the Behaviour Change Wheel framework and relevant cessation guidelines', 'mobile social network (WeChat)-based smoking cessation intervention (SCAMPI program']","['smoking abstinence', '30-day biochemically verified smoking abstinence', 'calculator function, motivational messages, and health tests', 'smoking status measures, reduction of cigarette consumption, study feasibility (recruitment and retention rate), and acceptability of and satisfaction with the program']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0220808', 'cui_str': 'Compensation'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0453056', 'cui_str': 'Scampi'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}]","[{'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0870240', 'cui_str': 'Calculator'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0459840', 'cui_str': 'Cigarette consumption'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",80.0,0.0814973,"At 6 weeks, 36 of 40 (90%) intervention participants and 35 of 40 (88%) control participants provided complete self-reported data on their daily smoking status via WeChat.","[{'ForeName': 'Jinsong', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'National Institute for Health Innovation, School of Population Health, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Elsie', 'Initials': 'E', 'LastName': 'Ho', 'Affiliation': 'School of Population Health, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Yannan', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'National Institute for Health Innovation, School of Population Health, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Robyn', 'Initials': 'R', 'LastName': 'Whittaker', 'Affiliation': 'National Institute for Health Innovation, School of Population Health, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Tingzhong', 'Initials': 'T', 'LastName': 'Yang', 'Affiliation': 'Centre for Tobacco Control Research, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Bullen', 'Affiliation': 'National Institute for Health Innovation, School of Population Health, University of Auckland, Auckland, New Zealand.'}]",JMIR mHealth and uHealth,['10.2196/17522']
2218,33095230,Rhythmic Auditory Stimulation and Gait Training in Traumatic Brain Injury: A Pilot Study.,"Rhythmic auditory stimulation (RAS) has been well researched with stroke survivors and individuals who have Parkinson's disease, but little research exists on RAS with people who have experienced traumatic brain injury (TBI). This pilot study aimed to (1) assess the feasibility of the study design and (2) explore potential benefits. This single-arm clinical trial included 10 participants who had a 2-week control period between baseline and pretreatment. Participants had RAS daily for a 2-week treatment period and immediately completed post-treatment assessments. Participants then had a 1-week control period and completed follow-up assessment. The starting cadence was evaluated each day of the intervention period due to the variation in daily functioning in this population. All 10 participants were 1-20 years post-TBI with notable deviations in spatial-temporal aspects of gait including decreased velocity, step symmetry, and cadence. All participants had a high risk of falling as defined by achieving less than 22 on the Functional Gait Assessment (FGA). The outcome measures included the 10-m walk test, spatial and temporal gait parameters, FGA, and Physical Activity Enjoyment Scale. There were no adverse events during the study and gait parameters improved. After the intervention, half of the participants achieved a score of more than 22 on the FGA, indicating that they were no longer at high risk of experiencing falls.",2020,All participants had a high risk of falling as defined by achieving less than 22 on the Functional Gait Assessment (FGA).,"['Traumatic Brain Injury', 'All 10 participants were 1-20 years post-TBI with notable deviations in spatial-temporal aspects of gait including decreased velocity, step symmetry, and cadence', 'All participants had a high risk of falling as defined by achieving less than 22 on the Functional Gait Assessment (FGA', ""stroke survivors and individuals who have Parkinson's disease"", '10 participants who had a 2-week control period between baseline and pretreatment']","['Rhythmic Auditory Stimulation and Gait Training', 'Rhythmic auditory stimulation (RAS']","['adverse events', '10-m walk test, spatial and temporal gait parameters, FGA, and Physical Activity Enjoyment Scale']","[{'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0442043', 'cui_str': 'Temporal'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0332516', 'cui_str': 'Symmetrical'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]","[{'cui': 'C0001164', 'cui_str': 'Stimulation, Acoustic'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0442043', 'cui_str': 'Temporal'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",10.0,0.129273,All participants had a high risk of falling as defined by achieving less than 22 on the Functional Gait Assessment (FGA).,"[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Thompson', 'Affiliation': 'Rehabilitative Rhythms, Aurora, CO, USA.'}, {'ForeName': 'Kaitlin', 'Initials': 'K', 'LastName': 'Hays', 'Affiliation': 'Craig Hospital, Englewood, CO, USA.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Weintraub', 'Affiliation': 'Craig Hospital, Englewood, CO, USA.'}, {'ForeName': 'Jessica M', 'Initials': 'JM', 'LastName': 'Ketchum', 'Affiliation': 'Craig Hospital, Englewood, CO, USA.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Kowalski', 'Affiliation': 'Craig Hospital, Englewood, CO, USA.'}]",Journal of music therapy,['10.1093/jmt/thaa016']
2219,33095333,Clinical differences between patients with early and late revision surgery for symptomatic failed arthroscopic rotator cuff repair.,"PURPOSE


Time ranges of revision rotator cuff surgeries after arthroscopic repair are highly variable. However, the cause and clinical relevance of the different timings of revision surgeries have not been analyzed. The purpose of this study was to evaluate the clinical manifestations of patients who required revision surgeries at early and late periods after failed arthroscopic rotator cuff repair, and to identify clinical and radiological differences related to the timing of revision surgery.
METHODS


Sixty patients who underwent revision surgery due to symptomatic failed rotator cuff repair after arthroscopic repair were included. Patients were divided into two groups: patients who underwent revision surgeries within 1 year postoperatively (21 patients, group I) and patients who underwent revision surgeries more than 1 year postoperatively (39 patients, group II). Clinical and radiological characteristics were compared between the two groups before primary and revision surgery.
RESULTS


VAS for pain (5.9 ± 1.9 in group I, 3.9 ± 1.4 in group II, P < 0.001) and Constant score (50.7 ± 9.9 in group I, 60.4 ± 8.9 in group II, P < 0.001) at the time of revision surgery were significantly different between the two groups. In group II, isometric muscle strength of forward flexion (74.1 ± 21.1 to 63.9 ± 15.1, P = 0.020) and external rotation (73.0 ± 23.5 to 61.2 ± 15.0, P = 0.032) were significantly deteriorated after primary surgery, even with significant improvement of pain and shoulder function (VAS: 5.7 ± 1.9 to 3.9 ± 1.4, P < 0.001; Constant score: 50.3 ± 11.0 to 60.4 ± 8.9, P < 0.001). On postoperative MRI, re-tear at the tendon-bone interface on the greater tuberosity occurred significantly more in group I (81.0%) than group II (51.3%, P = 0.024). Incidence of full-thickness tear of the subscapularis tendon was significantly different between the two groups (42.9% in group I, 12.8% in group II, P = 0.012).
CONCLUSION


Patients who had early revision surgeries had significantly worse clinical outcomes after primary surgery than patients who had late revision surgeries. Healing failure at the tendon-bone interface on the greater tuberosity and re-tear combined with full-thickness tear of subscapularis tendon were related to early revision. Conversely, patients of the late revision group had muscle weakness that considerably impacted daily activities, even with improved pain and shoulder function.
LEVEL OF EVIDENCE


III.",2020,"Incidence of full-thickness tear of the subscapularis tendon was significantly different between the two groups (42.9% in group I, 12.8% in group II, P = 0.012).
","['patients who required revision surgeries at early and late periods after failed arthroscopic rotator cuff repair', 'Sixty patients who underwent revision surgery due to symptomatic failed rotator cuff repair after arthroscopic repair were included', 'patients with early and late revision surgery for symptomatic failed arthroscopic rotator cuff repair']",['revision surgeries'],"['Incidence of full-thickness tear of the subscapularis tendon', 'pain and shoulder function', 'muscle weakness', 'time of revision surgery', 'Constant score', 'Healing failure', 'clinical outcomes', 'external rotation', 'isometric muscle strength of forward flexion', 'postoperative MRI, re-tear at the tendon-bone interface on the greater tuberosity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0240322', 'cui_str': 'Menstrual period late'}, {'cui': 'C0186666', 'cui_str': 'Repair of musculotendinous cuff of shoulder'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205087', 'cui_str': 'Late'}]","[{'cui': 'C0035110', 'cui_str': 'Reoperation'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439809', 'cui_str': 'Full thickness'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0559987', 'cui_str': 'Entire tendon of subscapularis muscle'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0030552', 'cui_str': 'Paresis'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0231462', 'cui_str': 'External rotation'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0439780', 'cui_str': 'Forward'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0039508', 'cui_str': 'Tendon structure'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0205393', 'cui_str': 'Most'}]",60.0,0.0394722,"Incidence of full-thickness tear of the subscapularis tendon was significantly different between the two groups (42.9% in group I, 12.8% in group II, P = 0.012).
","[{'ForeName': 'Sanghyeon', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Department of Orthopedic Surgery, College of Medicine, Ewha Womans University Seoul Hospital, 260, Gonghang-daero, Gangseo-gu, Seoul, 07985, Republic of Korea.'}, {'ForeName': 'In', 'Initials': 'I', 'LastName': 'Park', 'Affiliation': 'Department of Orthopedic Surgery, College of Medicine, Ewha Womans University Seoul Hospital, 260, Gonghang-daero, Gangseo-gu, Seoul, 07985, Republic of Korea.'}, {'ForeName': 'Min-Su', 'Initials': 'MS', 'LastName': 'Kim', 'Affiliation': 'Department of Orthopedic Surgery, College of Medicine, Ewha Womans University Seoul Hospital, 260, Gonghang-daero, Gangseo-gu, Seoul, 07985, Republic of Korea.'}, {'ForeName': 'Sang-Jin', 'Initials': 'SJ', 'LastName': 'Shin', 'Affiliation': 'Department of Orthopedic Surgery, College of Medicine, Ewha Womans University Seoul Hospital, 260, Gonghang-daero, Gangseo-gu, Seoul, 07985, Republic of Korea. sjshin622@ewha.ac.kr.'}]","Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA",['10.1007/s00167-020-06333-6']
2220,33095658,Efficacy of microcurrent therapy for treatment of acute knee pain: A randomized double-blinded controlled clinical trial.,"OBJECTIVE


We would like to determine whether electrotherapy, specifically microcurrent therapy, increases function and decreases pain in people who have acute knee pain.
DESIGN


Randomized, double-blinded, placebo-controlled clinical trial.
SETTING


University laboratory and patient home.
SUBJECTS


A total of 52 subjects (35 females and 17 males) with acute knee pain.
INTERVENTION


Treatment group ( n  = 26) wore the active microcurrent therapy device at home for 3 hours per day for 4 weeks and the control group ( n  = 26) wore the placebo for 3 hours per day for 4 weeks.
MAIN MEASURES


Numeric Pain Rating Scale (NPRS) and Short Form 12 (SF-12) health scale were used to measure the pain level and the functionality of the participants. Secondary assessments included musculoskeletal ultrasound imaging (MSK US) and Lower Extremity Functional Scale (LEFS).
RESULTS


A total of 52 subjects completed the study; 26 in the treatment group and 26 in the control group. Microcurrent therapy significantly reduced pain over 4 weeks. Especially week three was significant ( P  < 0.01) after adjusting for the family-wise error rate. The analysis on SF-12 revealed those with microcurrent therapy showed an increasing trend in the improvement of physical function score until week three.
CONCLUSION


An active microcurrent therapy device decreased knee pain and increased function. Microcurrent therapy may be an alternative or used with a pharmacological approach for people with acute knee pain.",2020,"The analysis on SF-12 revealed those with microcurrent therapy showed an increasing trend in the improvement of physical function score until week three.
","['University laboratory and patient home', 'people who have acute knee pain', 'acute knee pain', 'A total of 52 subjects (35 females and 17 males) with acute knee pain', 'people with acute knee pain', '52 subjects completed the study; 26 in the treatment group and 26 in the control group']","['electrotherapy', 'Microcurrent therapy', 'microcurrent therapy', 'placebo', 'Treatment group ( n \u2009=\u200926) wore the active microcurrent therapy device']","['pain level and the functionality of the participants', 'Numeric Pain Rating Scale (NPRS) and Short Form 12 (SF-12) health scale', 'knee pain and increased function', 'physical function score', 'musculoskeletal ultrasound imaging (MSK US) and Lower Extremity Functional Scale (LEFS', 'pain']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0013787', 'cui_str': 'Electrotherapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C4305121', 'cui_str': 'Lower Extremity Functional Scale'}]",52.0,0.451954,"The analysis on SF-12 revealed those with microcurrent therapy showed an increasing trend in the improvement of physical function score until week three.
","[{'ForeName': 'Daryl', 'Initials': 'D', 'LastName': 'Lawson', 'Affiliation': 'Department of Physical Therapy, Western Michigan University, Kalamazoo, MI, USA.'}, {'ForeName': 'Kevin H', 'Initials': 'KH', 'LastName': 'Lee', 'Affiliation': 'Department of Statistics, Western Michigan University, Kalamazoo, MI, USA.'}, {'ForeName': 'Hyun Bin', 'Initials': 'HB', 'LastName': 'Kang', 'Affiliation': 'Department of Statistics, Western Michigan University, Kalamazoo, MI, USA.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Yang', 'Affiliation': 'Department of Physical Therapy, Elon University, Elon, NC, USA.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Llewellyn', 'Affiliation': 'Department of Physical Therapy, Elon University, Elon, NC, USA.'}, {'ForeName': 'Shozo', 'Initials': 'S', 'LastName': 'Takamatsu', 'Affiliation': 'OMRON Healthcare, Inc., Muko City, Kyoto, Japan.'}]",Clinical rehabilitation,['10.1177/0269215520965320']
2221,33095682,"Survival, Pathologic Response, and Genomics in CALGB 40601 (Alliance), a Neoadjuvant Phase III Trial of Paclitaxel-Trastuzumab With or Without Lapatinib in HER2-Positive Breast Cancer.","PURPOSE


CALGB 40601 assessed whether dual versus single human epidermal growth factor receptor 2 (HER2) -targeting drugs added to neoadjuvant chemotherapy increased pathologic complete response (pCR). Here, we report relapse-free survival (RFS), overall survival (OS), and gene expression signatures that predict pCR and survival.
PATIENTS AND METHODS


Three hundred five women with untreated stage II and III HER2-positive breast cancer were randomly assigned to receive weekly paclitaxel combined with trastuzumab plus lapatinib (THL), trastuzumab (TH), or lapatinib (TL). The primary end point was pCR, and secondary end points included RFS, OS, and gene expression analyses. mRNA sequencing was performed on 264 pretreatment samples.
RESULTS


One hundred eighteen patients were randomly allocated to THL, 120 to TH, and 67 to TL. At more than 7 years of follow-up, THL had significantly better RFS and OS than did TH (RFS hazard ratio, 0.32; 95% CI, 0.14 to 0.71;  P  = .005; OS hazard ratio, 0.34; 95% CI, 0.12 to 0.94;  P  = .037), with no difference between TH and TL. Of 688 previously described gene expression signatures, significant associations were found in 215 with pCR, 45 with RFS, and only 22 with both pCR and RFS (3.2%). Specifically, eight immune signatures were significantly correlated with a higher pCR rate and better RFS. Among patients with residual disease, the immunoglobulin G signature was an independent, good prognostic factor, whereas the HER2-enriched signature, which was associated with a higher pCR rate, showed a significantly shorter RFS.
CONCLUSION


In CALGB 40601, dual HER2-targeting resulted in significant RFS and OS benefits. Integration of intrinsic subtype and immune signatures allowed for the prediction of pCR and RFS, both overall and within the residual disease group. These approaches may provide means for rational escalation and de-escalation treatment strategies in HER2-positive breast cancer.",2020,"OS hazard ratio, 0.34; 95% CI, 0.12 to 0.94;  P  = .037), with no difference between TH and TL.","['Three hundred five women with untreated stage II and III HER2-positive breast cancer', 'HER2-positive breast cancer', 'One hundred eighteen patients', 'HER2-Positive Breast Cancer']","['Paclitaxel-Trastuzumab With or Without Lapatinib', 'THL', 'paclitaxel combined with trastuzumab plus lapatinib (THL), trastuzumab (TH), or lapatinib (TL']","['relapse-free survival (RFS), overall survival (OS), and gene expression signatures that predict pCR and survival', 'pathologic complete response (pCR', 'pCR, and secondary end points included RFS, OS, and gene expression analyses', 'pCR rate', 'pCR rate and better RFS', 'RFS and OS', 'Survival, Pathologic Response, and Genomics in CALGB 40601 (Alliance']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0242957', 'cui_str': 'Genes, erbb2'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C1506770', 'cui_str': 'lapatinib'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1956267', 'cui_str': 'Transcriptome Profiles'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C1521733', 'cui_str': 'Pathologic'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0341703', 'cui_str': 'Adult Fanconi syndrome'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0017428', 'cui_str': 'Genome'}]",305.0,0.0737803,"OS hazard ratio, 0.34; 95% CI, 0.12 to 0.94;  P  = .037), with no difference between TH and TL.","[{'ForeName': 'Aranzazu', 'Initials': 'A', 'LastName': 'Fernandez-Martinez', 'Affiliation': 'Lineberger Comprehensive Center, University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'Ian E', 'Initials': 'IE', 'LastName': 'Krop', 'Affiliation': 'Department of Medical Oncology, Dana-Farber/Partners CancerCare, Boston, MA.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Hillman', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Mei-Yin', 'Initials': 'MY', 'LastName': 'Polley', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Joel S', 'Initials': 'JS', 'LastName': 'Parker', 'Affiliation': 'Lineberger Comprehensive Center, University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Huebner', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Hoadley', 'Affiliation': 'Lineberger Comprehensive Center, University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Shepherd', 'Affiliation': 'Lineberger Comprehensive Center, University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Tolaney', 'Affiliation': 'Department of Medical Oncology, Dana-Farber/Partners CancerCare, Boston, MA.'}, {'ForeName': 'N Lynn', 'Initials': 'NL', 'LastName': 'Henry', 'Affiliation': 'University of Michigan Rogel Cancer Center, Ann Arbor, MI.'}, {'ForeName': 'Chau', 'Initials': 'C', 'LastName': 'Dang', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Lyndsay', 'Initials': 'L', 'LastName': 'Harris', 'Affiliation': 'National Cancer Institute, Cancer Diagnostics Program, Bethesda, MD.'}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Berry', 'Affiliation': 'Division of Biostatistics, MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Olwen', 'Initials': 'O', 'LastName': 'Hahn', 'Affiliation': 'Alliance Protocol Operations Office, University of Chicago, Chicago, IL.'}, {'ForeName': 'Clifford', 'Initials': 'C', 'LastName': 'Hudis', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Winer', 'Affiliation': 'Department of Medical Oncology, Dana-Farber/Partners CancerCare, Boston, MA.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Partridge', 'Affiliation': 'Department of Medical Oncology, Dana-Farber/Partners CancerCare, Boston, MA.'}, {'ForeName': 'Charles M', 'Initials': 'CM', 'LastName': 'Perou', 'Affiliation': 'Lineberger Comprehensive Center, University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Carey', 'Affiliation': 'Lineberger Comprehensive Center, University of North Carolina, Chapel Hill, NC.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.01276']
2222,33095756,Effect of the oral intake of astaxanthin on semen parameters in patients with oligo-astheno-teratozoospermia: a randomized double-blind placebo-controlled trial.,"Background Higher concentrations of seminal reactive oxygen species may be related to male infertility. Astaxanthin with high antioxidant activity can have an impact on the prevention and treatment of various health conditions, including cancer. However, efficacy studies on astaxanthin in patients with oligospermia with/without astheno- or teratozoospermia (O±A±T) have not yet been reported. Our aim was to evaluate the effect of the oral intake of astaxanthin on semen parameters. Patients and methods In a randomized double-blind trial, 80 men with O±A±T were allocated to intervention with 16 mg astaxanthin orally daily or placebo. At baseline and after three months basic semen parameters, sperm deoxyribonucleic acid (DNA) fragmentation and mitochondrial membrane potential (MMP) of spermatozoa and serum follicle-stimulating hormone (FSH) value were measured. Results Analysis of the results of 72 patients completing the study (37 in the study group, 35 in the placebo group) did not show any statistically significant change, in the astaxanthin group no improvements in the total number of spermatozoa, concentration of spermatozoa, total motility of spermatozoa, morphology of spermatozoa, DNA fragmentation and mitochondrial membrane potential of spermatozoa or serum FSH were determined. In the placebo group, statistically significant changes in the total number and concentration of spermatozoa were determined. Conclusions The oral intake of astaxanthin did not affect any semen parameters in patients with O±A±T.",2020,"In the placebo group, statistically significant changes in the total number and concentration of spermatozoa were determined.","['80 men with O±A±T', 'patients with O±A±T', 'patients with oligo-astheno-teratozoospermia', 'patients with oligospermia with/without astheno- or teratozoospermia (O±A±T']","['placebo', 'astaxanthin', 'astaxanthin orally daily or placebo', 'Astaxanthin with high antioxidant activity']","['total number and concentration of spermatozoa', 'sperm deoxyribonucleic acid (DNA) fragmentation and mitochondrial membrane potential (MMP) of spermatozoa and serum follicle-stimulating hormone (FSH) value', 'total number of spermatozoa, concentration of spermatozoa, total motility of spermatozoa, morphology of spermatozoa, DNA fragmentation and mitochondrial membrane potential of spermatozoa or serum FSH']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028953', 'cui_str': 'Oligonucleotide'}, {'cui': 'C0403823', 'cui_str': 'Asthenospermia'}, {'cui': 'C0028960', 'cui_str': 'Oligospermia'}, {'cui': 'C0403824', 'cui_str': 'Teratozoospermia'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0052565', 'cui_str': 'astaxanthin'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0037868', 'cui_str': 'Spermatozoa'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic acid'}, {'cui': 'C0332472', 'cui_str': 'Fragmentation'}, {'cui': 'C1720920', 'cui_str': 'Mitochondrial Membrane Potential'}, {'cui': 'C0857927', 'cui_str': 'Serum follicle stimulating hormone'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0037848', 'cui_str': 'Motility of spermatozoa'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}, {'cui': 'C0376669', 'cui_str': 'DNA Fragmentation'}, {'cui': 'C0455276', 'cui_str': 'Serum follicle stimulating hormone measurement'}]",80.0,0.575105,"In the placebo group, statistically significant changes in the total number and concentration of spermatozoa were determined.","[{'ForeName': 'Senka Imamovic', 'Initials': 'SI', 'LastName': 'Kumalic', 'Affiliation': 'Division of Obstetrics and Gynecology, University Medical Centre Ljubljana, Ljubljana, Slovenia.'}, {'ForeName': 'Irma Virant', 'Initials': 'IV', 'LastName': 'Klun', 'Affiliation': 'Division of Obstetrics and Gynecology, University Medical Centre Ljubljana, Ljubljana, Slovenia.'}, {'ForeName': 'Eda Vrtacnik', 'Initials': 'EV', 'LastName': 'Bokal', 'Affiliation': 'Division of Obstetrics and Gynecology, University Medical Centre Ljubljana, Ljubljana, Slovenia.'}, {'ForeName': 'Bojana', 'Initials': 'B', 'LastName': 'Pinter', 'Affiliation': 'Division of Obstetrics and Gynecology, University Medical Centre Ljubljana, Ljubljana, Slovenia.'}]",Radiology and oncology,['10.2478/raon-2020-0062']
2223,33095777,Perceived facilitators and barriers among physical therapists and orthopedic surgeons to pre-operative home-based exercise with one exercise-only in patients eligible for knee replacement: A qualitative interview study nested in the QUADX-1 trial.,"AIM


Clinical guidelines recommend non-surgical treatment before surgery is considered in patients eligible for knee replacement. Surgical treatment is provided by orthopedic surgeons and exercise therapy is provided by physical therapists. The aim of this study was to identify perceived facilitators and barriers-among orthopedic surgeons and physical therapists-towards coordinated non-surgical and surgical treatment of patients eligible for knee replacement using pre-operative home-based exercise therapy with one exercise.
METHODS


This qualitative study is embedded within the QUADX-1 randomized trial that investigates a model of coordinated non-surgical and surgical treatment for patients eligible for knee replacement. Physical therapists and orthopedic surgeons working with patients with knee osteoarthritis in their daily clinical work were interviewed (one focus group and four single interviews) to explore their perceived facilitators and barriers related to pre-operative home-based exercise therapy with one exercise-only in patients eligible for knee replacement. Interviews were analyzed using thematic analysis.
RESULTS


From the thematic analysis three main themes emerged: 1) Physical therapists' dilemma with one home-based exercise, 2) Orthopedic surgeons' dilemma with exercise, and 3) Coordinated non-surgical and surgical care.
CONCLUSION


We found that the pre-operative exercise intervention created ambivalence in the professional role of both the physical therapists and orthopedic surgeons. The physical therapists were skeptical towards over-simplified exercise therapy. The orthopedic surgeons were skeptical towards the potential lack of (long-term) effect of exercise therapy in patients eligible for knee replacement. The consequence of these barriers and ambivalence in the professional role is important to consider when planning implementation of the model of coordinated non-surgical and surgical treatment.
TRIAL REGISTRATION


ClinicalTrials.gov, ID: NCT02931058.",2020,The orthopedic surgeons were skeptical towards the potential lack of (long-term) effect of exercise therapy in patients eligible for knee replacement.,"['patients eligible for', 'patients eligible for knee replacement', 'patients with knee osteoarthritis in their daily clinical work']","['explore their perceived facilitators and barriers related to pre-operative home-based exercise therapy with one exercise-only', 'physical therapists and orthopedic surgeons to pre-operative home-based exercise with one exercise-only', 'orthopedic surgeons and physical therapists-towards coordinated non-surgical and surgical treatment', ""Physical therapists' dilemma with one home-based exercise, 2) Orthopedic surgeons' dilemma with exercise, and 3) Coordinated non-surgical and surgical care"", 'Physical therapists', 'knee replacement using pre-operative home-based exercise therapy with one exercise', 'exercise therapy']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0043227', 'cui_str': 'Working'}]","[{'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205171', 'cui_str': 'Singular'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0334891', 'cui_str': 'Orthopedic surgeon'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0427184', 'cui_str': 'No incoordination'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]",[],,0.0574234,The orthopedic surgeons were skeptical towards the potential lack of (long-term) effect of exercise therapy in patients eligible for knee replacement.,"[{'ForeName': 'Rasmus Skov', 'Initials': 'RS', 'LastName': 'Husted', 'Affiliation': 'Department of Clinical Research, Copenhagen University Hospital Amager-Hvidovre, Hvidovre, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bandholm', 'Affiliation': 'Department of Clinical Research, Copenhagen University Hospital Amager-Hvidovre, Hvidovre, Denmark.'}, {'ForeName': 'Michael Skovdal', 'Initials': 'MS', 'LastName': 'Rathleff', 'Affiliation': 'Research Unit for General Practice in Aalborg, Department of Clinical Medicine, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Troelsen', 'Affiliation': 'Department of Orthopedic Surgery, Clinical Orthopedic Research Hvidovre (CORH), Copenhagen University Hospital Amager-Hvidovre, Hvidovre, Denmark.'}, {'ForeName': 'Jeanette', 'Initials': 'J', 'LastName': 'Kirk', 'Affiliation': 'Department of Clinical Research, Copenhagen University Hospital Amager-Hvidovre, Hvidovre, Denmark.'}]",PloS one,['10.1371/journal.pone.0241175']
2224,33095798,A cluster feasibility trial to explore the uptake and use of e-cigarettes versus usual care offered to smokers attending homeless centres in Great Britain.,"Smoking rates in the UK are at an all-time low but this masks considerable inequalities; prevalence amongst adults who are homeless remains four times higher than the national average. The objective of this trial was to assess the feasibility of supplying free e-cigarette starter kits to smokers accessing homeless centres and to estimate parameters to inform a possible future larger trial. In this feasibility cluster trial, four homeless centres in Great Britain were non-randomly allocated to either a Usual Care (UC) or E-Cigarette (EC) arm. Smokers attending the centres were recruited by staff. UC arm participants (N = 32) received advice to quit and signposting to the local Stop Smoking Service. EC arm participants (N = 48) received an EC starter kit and 4-weeks supply of e-liquid. Outcome measures were recruitment and retention rates, use of ECs, smoking cessation/reduction and completion of measures required for economic evaluation. Eighty (mean age 43 years; 65% male) of the 153 eligible participants who were invited to participate, were successfully recruited (52%) within a five-month period, and 47 (59%) of these were retained at 24 weeks. The EC intervention was well received with minimal negative effects and very few unintended consequences (e.g. lost, theft, adding illicit substances). In both study arm, depression and anxiety scores declined over the duration of the study. Substance dependence scores remained constant. Assuming those with missing follow up data were smoking, CO validated sustained abstinence at 24 weeks was 3/48 (6.25%) and 0/32 (0%) respectively for the EC and UC arms. Almost all participants present at follow-up visits completed data collection for healthcare service and health-related quality of life measures. Providing an e-cigarette starter kit to smokers experiencing homelessness was associated with reasonable recruitment and retention rates and promising evidence of effectiveness and cost-effectiveness.",2020,Providing an e-cigarette starter kit to smokers experiencing homelessness was associated with reasonable recruitment and retention rates and promising evidence of effectiveness and cost-effectiveness.,"['Smokers attending the centres were recruited by staff', 'smokers accessing homeless centres', 'smokers attending homeless centres in Great Britain', 'age 43 years; 65% male) of the 153 eligible participants who were invited to participate, were successfully recruited (52%) within a five-month period, and 47 (59%) of these were retained at 24 weeks', 'Eighty (mean', 'four homeless centres in Great Britain']","['advice to quit and signposting to the local Stop Smoking Service', 'Usual Care (UC) or E-Cigarette (EC', 'EC', 'supplying free e-cigarette starter kits', 'e-cigarettes versus usual care', 'EC starter kit and 4-weeks supply of e-liquid']","['recruitment and retention rates, use of ECs, smoking cessation/reduction and completion of measures required for economic evaluation', 'Smoking rates', 'depression and anxiety scores', 'Substance dependence scores']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0237154', 'cui_str': 'Homeless'}, {'cui': 'C0018223', 'cui_str': 'Great Britain'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]","[{'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0425310', 'cui_str': 'Stopped smoking'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0812225', 'cui_str': 'Device kit'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4543628', 'cui_str': 'Electronic cigarette liquid'}]","[{'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0150099', 'cui_str': 'Economic Evaluation'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0038580', 'cui_str': 'Substance dependence'}]",153.0,0.0773539,Providing an e-cigarette starter kit to smokers experiencing homelessness was associated with reasonable recruitment and retention rates and promising evidence of effectiveness and cost-effectiveness.,"[{'ForeName': 'Lynne', 'Initials': 'L', 'LastName': 'Dawkins', 'Affiliation': 'Centre for Addictive Behaviours Research, London South Bank University, London, England.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Bauld', 'Affiliation': 'Usher Institute and SPECTRUM Consortium, Old Medical School, University of Edinburgh, Edinburgh, Scotland.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Ford', 'Affiliation': 'Institute for Social Marketing and Health, Faculty of Health Sciences and Sport, University of Stirling, Stirling, Scotland.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Robson', 'Affiliation': ""National Addiction Centre and SPECTRUM Consortium, Addictions Department & ARC South London, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, England.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hajek', 'Affiliation': 'Wolfson Institute of Preventive Medicine, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, England.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Parrott', 'Affiliation': 'Department of Health Sciences, University of York, York, England.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Best', 'Affiliation': 'Institute for Social Marketing and Health, Faculty of Health Sciences and Sport, University of Stirling, Stirling, Scotland.'}, {'ForeName': 'Jinshuo', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Health Sciences, University of York, York, England.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Tyler', 'Affiliation': 'Centre for Addictive Behaviours Research, London South Bank University, London, England.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Uny', 'Affiliation': 'Institute for Social Marketing and Health, Faculty of Health Sciences and Sport, University of Stirling, Stirling, Scotland.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Cox', 'Affiliation': 'Centre for Addictive Behaviours Research, London South Bank University, London, England.'}]",PloS one,['10.1371/journal.pone.0240968']
2225,33095817,The effect of metacognitive training on confidence and strategic reminder setting.,"Individuals often choose between remembering information using their own memory ability versus using external resources to reduce cognitive demand (i.e. 'cognitive offloading'). For example, to remember a future appointment an individual could choose to set a smartphone reminder or depend on their unaided memory ability. Previous studies investigating strategic reminder setting found that participants set more reminders than would be optimal, and this bias towards reminder-setting was predicted by metacognitive underconfidence in unaided memory ability. Due to the link between underconfidence in memory ability and excessive reminder setting, the aim of the current study was to investigate whether metacognitive training is an effective intervention to a) improve metacognitive judgment accuracy, and b) reduce bias in strategic offloading behaviour. Participants either received metacognitive training which involved making performance predictions and receiving feedback on judgment accuracy, or were part of a control group. As predicted, metacognitive training increased judgment accuracy: participants in the control group were significantly underconfident in their memory ability, whereas the experimental group showed no significant metacognitive bias. However, contrary to predictions, both experimental and control groups were significantly biased toward reminder-setting, and did not differ significantly. Therefore, reducing metacognitive bias was not sufficient to eliminate the bias towards reminders. We suggest that the reminder bias likely results in part from erroneous metacognitive evaluations, but that other factors such as a preference to avoid cognitive effort may also be relevant. Finding interventions to mitigate these factors could improve the adaptive use of external resources.",2020,"As predicted, metacognitive training increased judgment accuracy: participants in the control group were significantly underconfident in their memory ability, whereas the experimental group showed no significant metacognitive bias.",[],['metacognitive training'],"['metacognitive training increased judgment accuracy', 'metacognitive bias']",[],"[{'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0022423', 'cui_str': 'Judgement'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0005346', 'cui_str': 'Biases'}]",,0.0170334,"As predicted, metacognitive training increased judgment accuracy: participants in the control group were significantly underconfident in their memory ability, whereas the experimental group showed no significant metacognitive bias.","[{'ForeName': 'Nicole C', 'Initials': 'NC', 'LastName': 'Engeler', 'Affiliation': 'UCL Institute of Cognitive Neuroscience, London, United Kingdom.'}, {'ForeName': 'Sam J', 'Initials': 'SJ', 'LastName': 'Gilbert', 'Affiliation': 'UCL Institute of Cognitive Neuroscience, London, United Kingdom.'}]",PloS one,['10.1371/journal.pone.0240858']
2226,33095849,Effect of Regional Citrate Anticoagulation vs Systemic Heparin Anticoagulation During Continuous Kidney Replacement Therapy on Dialysis Filter Life Span and Mortality Among Critically Ill Patients With Acute Kidney Injury: A Randomized Clinical Trial.,"Importance


Although current guidelines suggest the use of regional citrate anticoagulation (which involves the addition of a citrate solution to the blood before the filter of the extracorporeal dialysis circuit) as first-line treatment for continuous kidney replacement therapy in critically ill patients, the evidence for this recommendation is based on few clinical trials and meta-analyses.
Objective


To determine the effect of regional citrate anticoagulation, compared with systemic heparin anticoagulation, on filter life span and mortality.
Design, Setting, and Participants


A parallel-group, randomized multicenter clinical trial in 26 centers across Germany was conducted between March 2016 and December 2018 (final date of follow-up, January 21, 2020). The trial was terminated early after 596 critically ill patients with severe acute kidney injury or clinical indications for initiation of kidney replacement therapy had been enrolled.
Interventions


Patients were randomized to receive either regional citrate anticoagulation (n = 300), which consisted of a target ionized calcium level of 1.0 to 1.40 mg/dL, or systemic heparin anticoagulation (n = 296), which consisted of a target activated partial thromboplastin time of 45 to 60 seconds, for continuous kidney replacement therapy.
Main Outcomes and Measures


Coprimary outcomes were filter life span and 90-day mortality. Secondary end points included bleeding complications and new infections.
Results


Among 638 patients randomized, 596 (93.4%) (mean age, 67.5 years; 183 [30.7%] women) completed the trial. In the regional citrate group vs systemic heparin group, median filter life span was 47 hours (interquartile range [IQR], 19-70 hours) vs 26 hours (IQR, 12-51 hours) (difference, 15 hours [95% CI, 11 to 20 hours]; P < .001). Ninety-day all-cause mortality occurred in 150 of 300 patients vs 156 of 296 patients (Kaplan-Meier estimator percentages, 51.2% vs 53.6%; unadjusted difference, -2.4% [95% CI, -10.5% to 5.8%]; unadjusted hazard ratio, 0.91 [95% CI, 0.72 to 1.13]; unadjusted P = .38; adjusted difference, -6.1% [95% CI, -12.6% to 0.4%]; primary adjusted hazard ratio, 0.79 [95% CI, 0.63 to 1.004]; primary adjusted P = .054). Of 38 prespecified secondary end points, 34 showed no significant difference. Compared with the systemic heparin group, the regional citrate group had significantly fewer bleeding complications (15/300 [5.1%] vs 49/296 [16.9%]; difference, -11.8% [95% CI, -16.8% to -6.8%]; P < .001) and significantly more new infections (204/300 [68.0%] vs 164/296 [55.4%]; difference, 12.6% [95% CI, 4.9% to 20.3%]; P = .002).
Conclusions and Relevance


Among critically ill patients with acute kidney injury receiving continuous kidney replacement therapy, anticoagulation with regional citrate, compared with systemic heparin anticoagulation, resulted in significantly longer filter life span. The trial was terminated early and was therefore underpowered to reach conclusions about the effect of anticoagulation strategy on mortality.
Trial Registration


ClinicalTrials.gov Identifier: NCT02669589.",2020,"Ninety-day all-cause mortality occurred in 150 of 300 patients vs 156 of 296 patients (Kaplan-Meier estimator percentages, 51.2% vs 53.6%; unadjusted difference, -2.4% [95% CI, -10.5% to 5.8%]; unadjusted hazard ratio, 0.91","['Critically Ill Patients With Acute Kidney Injury', '26 centers across Germany was conducted between March 2016 and December 2018 (final date of follow-up, January 21, 2020', '638 patients randomized, 596 (93.4%) (mean age, 67.5 years; 183 [30.7%] women) completed the trial', 'critically ill patients with acute kidney injury receiving', 'critically ill patients', '596 critically ill patients with severe acute kidney injury or clinical indications for initiation of kidney replacement therapy had been enrolled']","['systemic heparin', 'regional citrate anticoagulation (n\u2009=\u2009300), which consisted of a target ionized calcium level of 1.0 to 1.40 mg/dL, or systemic heparin anticoagulation', 'continuous kidney replacement therapy, anticoagulation with regional citrate', 'systemic heparin anticoagulation', 'regional citrate anticoagulation', 'continuous kidney replacement therapy', 'Regional Citrate Anticoagulation vs Systemic Heparin Anticoagulation']","['bleeding complications and new infections', 'cause mortality', 'bleeding complications', 'filter life span and mortality', 'longer filter life span', 'median filter life span', 'Dialysis Filter Life Span and Mortality', 'mortality', 'filter life span and 90-day mortality', 'new infections']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517615', 'cui_str': '183'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0008857', 'cui_str': 'Citrates'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0373561', 'cui_str': 'Calcium electrolyte'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0439633', 'cui_str': 'New infection'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0180860', 'cui_str': 'Filter'}, {'cui': 'C0870809', 'cui_str': 'Lifespan'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",638.0,0.468136,"Ninety-day all-cause mortality occurred in 150 of 300 patients vs 156 of 296 patients (Kaplan-Meier estimator percentages, 51.2% vs 53.6%; unadjusted difference, -2.4% [95% CI, -10.5% to 5.8%]; unadjusted hazard ratio, 0.91","[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Zarbock', 'Affiliation': 'Department of Anesthesiology, Intensive Care and Pain Medicine, University of Münster, Münster, Germany.'}, {'ForeName': 'Mira', 'Initials': 'M', 'LastName': 'Küllmar', 'Affiliation': 'Department of Anesthesiology, Intensive Care and Pain Medicine, University of Münster, Münster, Germany.'}, {'ForeName': 'Detlef', 'Initials': 'D', 'LastName': 'Kindgen-Milles', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Heinrich-Heine University of Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Carola', 'Initials': 'C', 'LastName': 'Wempe', 'Affiliation': 'Department of Anesthesiology, Intensive Care and Pain Medicine, University of Münster, Münster, Germany.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Gerss', 'Affiliation': 'Institute of Biostatistics and Clinical Research, University of Münster, Münster, Germany.'}, {'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Brandenburger', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Heinrich-Heine University of Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Dimski', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Heinrich-Heine University of Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Bartosz', 'Initials': 'B', 'LastName': 'Tyczynski', 'Affiliation': 'Department of Nephrology, University Hospital Essen, Essen, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Jahn', 'Affiliation': 'Department of Nephrology, University Hospital Essen, Essen, Germany.'}, {'ForeName': 'Nils', 'Initials': 'N', 'LastName': 'Mülling', 'Affiliation': 'Department of Nephrology, University Hospital Essen, Essen, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Mehrländer', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, University Hospital Tübingen, Eberhard Karls University Tübingen, Tübingen, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Rosenberger', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, University Hospital Tübingen, Eberhard Karls University Tübingen, Tübingen, Germany.'}, {'ForeName': 'Gernot', 'Initials': 'G', 'LastName': 'Marx', 'Affiliation': 'Department of Intensive Care Medicine, University of Aachen, Aachen, Germany.'}, {'ForeName': 'Tim Philipp', 'Initials': 'TP', 'LastName': 'Simon', 'Affiliation': 'Department of Intensive Care Medicine, University of Aachen, Aachen, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Jaschinski', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, University Hospital Augsburg, Augsburg, Germany.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Deetjen', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, University Hospital Augsburg, Augsburg, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Putensen', 'Affiliation': 'University Hospital Bonn, Department of Anesthesiology and Intensive Care Medicine, Bonn, Germany.'}, {'ForeName': 'Jens-Christian', 'Initials': 'JC', 'LastName': 'Schewe', 'Affiliation': 'University Hospital Bonn, Department of Anesthesiology and Intensive Care Medicine, Bonn, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Kluge', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Department of Intensive Care, Hamburg, Germany.'}, {'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Jarczak', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Department of Intensive Care, Hamburg, Germany.'}, {'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Slowinski', 'Affiliation': 'Department of Nephrology and Medical Intensive Care, Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Bodenstein', 'Affiliation': 'Universitätsmedizin Mainz, Department of Anesthesiology, Mainz, Germany.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Meybohm', 'Affiliation': 'Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Wirtz', 'Affiliation': 'Department of Anesthesiology, Intensive Care and Pain Medicine, Helios Klinikum Bad Saarow, Bad Saarow, Germany.'}, {'ForeName': 'Onnen', 'Initials': 'O', 'LastName': 'Moerer', 'Affiliation': 'Department of Anesthesiology, University Medical Center Göttingen, Göttingen, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Kortgen', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, University Hospital Jena, Jena, Germany.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Simon', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, University Hospital Leipzig, Leipzig, Germany.'}, {'ForeName': 'Sean M', 'Initials': 'SM', 'LastName': 'Bagshaw', 'Affiliation': 'Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton, Alberta, Canada.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Kellum', 'Affiliation': 'Center for Critical Care Nephrology, Department of Critical Care Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Meersch', 'Affiliation': 'Department of Anesthesiology, Intensive Care and Pain Medicine, University of Münster, Münster, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2020.18618']
2227,33096121,A randomized controlled trial on the influence of two types of exercise training vs control on visuospatial processing and mathematical skills: the role of cortisol.,"While physical exercise training (PET) is undoubtedly very important for children and adolescents, there is still a lack of research dealing with the specific impact of different types of PET on cognitive and academic performance and the activity of the hypothalamic-pituitary-adrenal (HPA) axis. The purpose of this study was to compare the impact of two different types of exercise training on visuospatial processing and mathematical skills in adolescents with the analysis of cortisol. We randomly assigned 135 adolescents (12-15 years of age) into three groups: coordinative exercise (CE), cardiovascular exercise (CVE), and control (CON) group. Computerized cognitive test (matching grids), mathematical skills and salivary cortisol level were evaluated before and after 10 weeks of PET (three times per week for 45 min) after school. Reaction time of the matching grids task decreased in all groups while the accuracy was better in CE comparing to control. In addition, the CE group improved the mathematical skills. The participants who improved visuospatial performance had higher mathematics scores after the intervention. However, we did't find any effect of the exercise training intervention on salivary cortisol nor on the link between cortisol and visuospatial processing. Future research should analyze the moderators that influence this link.",2020,"However, we did't find any effect of the exercise training intervention on salivary cortisol nor on the link between cortisol and visuospatial processing.","['135 adolescents (12-15 years of age) into three groups', 'adolescents with the analysis of cortisol', 'children and adolescents']","['coordinative exercise (CE), cardiovascular exercise (CVE), and control (CON) group', 'physical exercise training (PET', 'exercise training', 'exercise training intervention', 'CE']","['mathematics scores', 'mathematical skills', 'Reaction time of the matching grids task', 'salivary cortisol nor on the link between cortisol and visuospatial processing', 'visuospatial processing and mathematical skills', 'visuospatial performance', 'Computerized cognitive test (matching grids), mathematical skills and salivary cortisol level']","[{'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0024934', 'cui_str': 'Mathematics'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}]",135.0,0.0226615,"However, we did't find any effect of the exercise training intervention on salivary cortisol nor on the link between cortisol and visuospatial processing.","[{'ForeName': 'Justė', 'Initials': 'J', 'LastName': 'Knatauskaitė', 'Affiliation': 'Institute of Sport Science and Innovations, Lithuanian Sports University, Kaunas 44221, Lithuania. Electronic address: juste.knatauskaite@gmail.com.'}, {'ForeName': 'Kazimieras', 'Initials': 'K', 'LastName': 'Pukėnas', 'Affiliation': 'Department of Health Promotion and Rehabilitation, Lithuanian Sports University, Kaunas 44221, Lithuania. Electronic address: kazimieras.pukenas@lsu.lt.'}, {'ForeName': 'Laima', 'Initials': 'L', 'LastName': 'Trinkūnienė', 'Affiliation': 'Department of Physical and Social Education, Lithuanian Sports University, Kaunas 44221, Lithuania. Electronic address: laima.trinkuniene@lsu.lt.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Budde', 'Affiliation': 'Institute of Sport Science and Innovations, Lithuanian Sports University, Kaunas 44221, Lithuania; Faculty of Human Sciences, Medical School Hamburg, Hamburg 20457, Germany. Electronic address: henning.budde@medicalschool-hamburg.de.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113213']
2228,33096126,Implementation science: Scaling a training intervention to include IUDs and implants in contraceptive services in primary care.,"Building capacity for contraceptive services in primary care settings, including for intrauterine devices (IUDs) and implants, can help to broaden contraceptive access across the US. Following a randomized trial in family planning clinics, we brought a provider training intervention to other clinical settings including primary care in all regions. This implementation science study evaluates a national scale-up of a contraceptive training intervention to varied practice settings from 2013 to 2019 among 3216 clinic staff serving an estimated 1.6 million annual contraceptive patients. We measured providers' knowledge and clinical practice changes regarding IUDs and implants using survey data. We estimated the overall intervention effect, and its relative effectiveness in primary care settings, with generalized estimating equations for clustered data. Patient-centered counseling improved, along with comfort with method provision and removal. Provider knowledge increased (p < 0.001), as did evidence-based counseling for IUDs (aOR 3.3 95% CI 2.8-3.9) and implants (aOR 3.5, 95% CI 3.0-4.1), and clinician competency in levonorgestrel IUDs (aOR 2.5 95% CI 2.1 3.1) and implants (aOR 2.4 95% CI 2.0-2.9). While proficiency was lower initially in primary care, gains were significant and at times greater than in Planned Parenthood health clinics. This intervention was effectively scaled, including in primary care settings with limited prior experience with these methods. Recent changes to Title X family planning funding rules exclude several large family planning providers, shifting greater responsibility to primary care and other settings. Scaling effective contraceptive interventions is one way to ensure capacity to offer patients full contraceptive services.",2020,"While proficiency was lower initially in primary care, gains were significant and at times greater than in Planned Parenthood health clinics.","['IUDs and implants in contraceptive services in primary care', 'patients full contraceptive services', '2013 to 2019 among 3216 clinic staff serving an estimated 1.6 million annual contraceptive patients', 'family planning clinics']","['provider training intervention', 'contraceptive training intervention']","['Provider knowledge', 'clinician competency in levonorgestrel IUDs']","[{'cui': 'C0021900', 'cui_str': 'Intrauterine contraceptive device'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C4517508', 'cui_str': '1.6'}, {'cui': 'C1881839', 'cui_str': '1000000'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C3840184', 'cui_str': 'Family planning clinic'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0023566', 'cui_str': 'Levonorgestrel'}, {'cui': 'C0021900', 'cui_str': 'Intrauterine contraceptive device'}]",,0.0657975,"While proficiency was lower initially in primary care, gains were significant and at times greater than in Planned Parenthood health clinics.","[{'ForeName': 'Cynthia C', 'Initials': 'CC', 'LastName': 'Harper', 'Affiliation': 'Bixby Center for Global Reproductive Health, Department of Obstetrics, Gynecology & Reproductive Sciences, University of California, San Francisco School of Medicine, United States of America. Electronic address: Cynthia.harper@ucsf.edu.'}, {'ForeName': 'Alison B', 'Initials': 'AB', 'LastName': 'Comfort', 'Affiliation': 'Bixby Center for Global Reproductive Health, Department of Obstetrics, Gynecology & Reproductive Sciences, University of California, San Francisco School of Medicine, United States of America.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Blum', 'Affiliation': 'Bixby Center for Global Reproductive Health, Department of Obstetrics, Gynecology & Reproductive Sciences, University of California, San Francisco School of Medicine, United States of America.'}, {'ForeName': 'Corinne H', 'Initials': 'CH', 'LastName': 'Rocca', 'Affiliation': 'Bixby Center for Global Reproductive Health, Department of Obstetrics, Gynecology & Reproductive Sciences, University of California, San Francisco School of Medicine, United States of America.'}, {'ForeName': 'Charles E', 'Initials': 'CE', 'LastName': 'McCulloch', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California, San Francisco School of Medicine, United States of America.'}, {'ForeName': 'Lavanya', 'Initials': 'L', 'LastName': 'Rao', 'Affiliation': 'Bixby Center for Global Reproductive Health, Department of Obstetrics, Gynecology & Reproductive Sciences, University of California, San Francisco School of Medicine, United States of America.'}, {'ForeName': 'Nishant', 'Initials': 'N', 'LastName': 'Shah', 'Affiliation': 'Consultant, Bixby Center for Global Reproductive Health, University of California, San Francisco, School of Medicine, United States of America.'}, {'ForeName': 'Helen Oquendo', 'Initials': 'HO', 'LastName': 'Del Toro', 'Affiliation': 'Department of Obstetrics and Gynecology, University of New Mexico School of Medicine, United States of America.'}, {'ForeName': 'Suzan', 'Initials': 'S', 'LastName': 'Goodman', 'Affiliation': 'Bixby Center for Global Reproductive Health, Department of Obstetrics, Gynecology & Reproductive Sciences, University of California, San Francisco School of Medicine, United States of America; Department of Family and Community Medicine, University of California, San Francisco School of Medicine, United States of America.'}]",Preventive medicine,['10.1016/j.ypmed.2020.106290']
2229,33096193,"Micro-computed tomography evaluation of dentinal micro-cracks after preparation of curved root canals with ProTaper Gold, WaveOne Gold and ProTaper NEXT instruments.","INTRODUCTION


The aim of this study was to evaluate the influence of rotary (ProTaper NEXT [PTN] and ProTaper Gold [PTG]) and reciprocating (WaveOne Gold [WOG]) systems in dentinal microcracks generation after preparation of curved root canals using micro-computed tomographic (micro-CT) analysis.
METHODS


Twenty-four human mandibular molars with curved roots were scanned in a micro-CT device using an isotropic resolution of 6.78 μm and randomly assigned into one of the three experimental groups (n = 8), according to the root canal instrumentation system used: PTN, PTG and WOG. Then, the root canals were prepared up to PTN X2, PTG F2 and WOG Primary instruments in PTN, PTG and WOG groups, respectively. After canal preparation, each specimen was scanned again. Pre- and post-operative cross-section images of the roots (N = 35,304) were analyzed to identify the presence of dentinal microcracks.
RESULTS


Overall, 26% of the images presented dentinal defects (n = 9,188). Dentinal microcracks were observed in 24.6%, 26% and 27.4% of the post-instrumentation images from PTN, PTG and WOG groups, respectively. However, all these dentinal microcracks were already present in the corresponding pre-operative images. No new microcrack were generated after the preparation of curved root canals of mandibular molars using the aforementioned systems.
CONCLUSION


Root canal instrumentation with PTN, PTG and WOG systems did not induce the formation of new dentinal microcracks.",2020,"CONCLUSION


Root canal instrumentation with PTN, PTG and WOG systems did not induce the formation of new dentinal microcracks.",['Twenty-four human mandibular molars with'],"['curved roots were scanned in a micro-CT device', 'rotary (ProTaper NEXT [PTN] and ProTaper Gold [PTG]) and reciprocating (WaveOne Gold [WOG']","['Dentinal microcracks', 'formation of new dentinal microcracks']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}]","[{'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0085672', 'cui_str': 'Microbiology procedure'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0018026', 'cui_str': 'Gold'}]","[{'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0205314', 'cui_str': 'New'}]",35304.0,0.0282475,"CONCLUSION


Root canal instrumentation with PTN, PTG and WOG systems did not induce the formation of new dentinal microcracks.","[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Miguéns-Vila', 'Affiliation': 'University of Santiago de Compostela, Facultad de Odontología, Entrerríos Street, no number. 15702, Santiago de Compostela.. Electronic address: ramon.miguens.vila@gmail.com.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Martín-Biedma', 'Affiliation': 'University of Santiago de Compostela, Facultad de Odontología, Entrerríos Street, no number. 15702, Santiago de Compostela.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'De-Deus', 'Affiliation': 'Fluminense Federal University.'}, {'ForeName': 'F G', 'Initials': 'FG', 'LastName': 'Belladonna', 'Affiliation': 'Fluminense Federal University.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Peña-López', 'Affiliation': 'European University of Madrid.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Castelo-Baz', 'Affiliation': 'University of Santiago de Compostela, Facultad de Odontología, Entrerríos Street, no number. 15702, Santiago de Compostela.'}]",Journal of endodontics,['10.1016/j.joen.2020.10.014']
2230,33096222,A randomised trial of an editorial intervention to reduce spin in the abstract's conclusion of manuscripts showed no significant effect.,"OBJECTIVE


To estimate the effect of an intervention compared to the usual peer-review process on reducing spin in the abstract's conclusion of biomedical study reports.
STUDY DESIGN AND SETTING


We conducted a two-arm, parallel-group RCT in a sample of primary research manuscripts submitted to BMJ Open. Authors received short instructions alongside the peer reviewers' comments in the intervention group. We assessed presence of spin (primary outcome), types of spin, and wording change in the revised abstract's conclusion. Outcome assessors were blinded to the intervention assignment.
RESULTS


Of the 184 manuscripts randomised, 108 (54 intervention, 54 control) were selected for revision and could be evaluated for the presence of spin. The proportion of manuscripts with spin was 6% lower (95% CI: 24% lower to 13% higher) in the intervention group (57%, 31/54) than in the control group (63%, 34/54). Wording of the revised abstract's conclusion was changed in 34/54 (63%) manuscripts in the intervention group and 26/54 (48%) in the control group. The four pre-specified types of spin involved: (i) selective reporting (12 in the intervention group versus 8 in the control group); (ii) including information not supported by evidence (9 versus 9); and (iii) interpretation not consistent with study results (14 versus 18); and (iv) unjustified recommendations for practice (5 versus 11).
CONCLUSION


These short instructions to authors did not have a statistically significant effect on reducing spin in revised abstract conclusions and, based on the confidence interval, the existence of a large effect can be excluded. Other interventions to reduce spin in reports of original research should be evaluated.
STUDY REGISTRATION


osf.io/xnuyt.",2020,"The proportion of manuscripts with spin was 6% lower (95% CI: 24% lower to 13% higher) in the intervention group (57%, 31/54) than in the control group (63%, 34/54).","['Of the 184 manuscripts randomised, 108 (54 intervention, 54 control']",['editorial intervention'],['proportion of manuscripts with spin'],"[{'cui': 'C4517616', 'cui_str': '184'}, {'cui': 'C0600659', 'cui_str': 'Manuscripts'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0282412', 'cui_str': 'Editorial'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0600659', 'cui_str': 'Manuscripts'}]",,0.0946132,"The proportion of manuscripts with spin was 6% lower (95% CI: 24% lower to 13% higher) in the intervention group (57%, 31/54) than in the control group (63%, 34/54).","[{'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Ghannad', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Amsterdam Public Health Research Institute, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands; Université de Paris, CRESS, INSERM, INRA, F-75004 Paris, France. Electronic address: m.ghannad@amsterdamumc.nl.'}, {'ForeName': 'Bada', 'Initials': 'B', 'LastName': 'Yang', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Amsterdam Public Health Research Institute, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands.'}, {'ForeName': 'Mariska', 'Initials': 'M', 'LastName': 'Leeflang', 'Affiliation': 'Université de Paris, CRESS, INSERM, INRA, F-75004 Paris, France.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Aldcroft', 'Affiliation': 'BMJ, London, UK.'}, {'ForeName': 'Patrick M', 'Initials': 'PM', 'LastName': 'Bossuyt', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Amsterdam Public Health Research Institute, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Schroter', 'Affiliation': 'BMJ, London, UK.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Boutron', 'Affiliation': 'Université de Paris, CRESS, INSERM, INRA, F-75004 Paris, France.'}]",Journal of clinical epidemiology,['10.1016/j.jclinepi.2020.10.014']
2231,33096225,Using virtual agents to increase physical activity in young children with the virtual fitness buddy ecosystem: Study protocol for a cluster randomized trial.,"BACKGROUND


Designing and implementing a truly self-determined physical activity (PA) intervention has required excessive amounts of labor and expenses that, until recently, have made it prohibitively costly to implement in the field at scale.
METHODS


Guided by self-determination theory, and harnessing the power of consumer-grade interactive technologies, we developed the Virtual Fitness Buddy (VFB) Ecosystem. Designed to foster intrinsic motivation toward adopting PA as a lifestyle change in 6-10-year-old children, the Ecosystem features a mixed-reality kiosk which houses a personalized virtual pet for each user. Each time a child visits the kiosk, the pet (a mid-sized dog) automatically detects its owner based on the data from a child's Fitbit, assists the child in setting daily PA goals and provides tailored feedback on the child's PA progress. The pet alerts parents in real-time by sending text messages and relaying the parents' response to the child, so that parents and children can remain connected about the child's PA progress even when they are physically apart. We aim to implement the kiosk in 12 after-school sites, plus use 12 additional sites as controls, where children can still set and view progress toward their PA goals without access to a virtual pet.
CONCLUSION


The VFB Ecosystem represents a new generation of technology-mediated health interventions for children to promote sustainable PA lifestyle changes. Because the VFB Ecosystem is a cost- and labor-effective solution that integrates consumer-grade technology with low barriers for continued use, it has the potential for rapid diffusion and widespread public health impact.",2020,"Each time a child visits the kiosk, the pet (a mid-sized dog) automatically detects its owner based on the data from a child's Fitbit, assists the child in setting daily PA goals and provides tailored feedback on the child's PA progress.","['young children with the virtual fitness buddy ecosystem', '6-10-year-old children']",['physical activity (PA) intervention'],['physical activity'],"[{'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0162358', 'cui_str': 'Ecologic Systems'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}]",,0.0209068,"Each time a child visits the kiosk, the pet (a mid-sized dog) automatically detects its owner based on the data from a child's Fitbit, assists the child in setting daily PA goals and provides tailored feedback on the child's PA progress.","[{'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Hahn', 'Affiliation': 'Department of Communication, University at Buffalo, State University of New York, United States. Electronic address: Lhahn2@buffalo.edu.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Schmidt', 'Affiliation': 'College of Education, University of Georgia, United States.'}, {'ForeName': 'Stephen L', 'Initials': 'SL', 'LastName': 'Rathbun', 'Affiliation': 'College of Public Health, University of Georgia, United States.'}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Johnsen', 'Affiliation': 'College of Engineering, University of Georgia, United States.'}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Annesi', 'Affiliation': 'YMCA of Metro Atlanta, United States; School of Health Professions, University of Alabama at Birmingham, United States.'}, {'ForeName': 'Sun Joo', 'Initials': 'SJ', 'LastName': 'Ahn', 'Affiliation': 'Grady College of Journalism & Mass Communication, University of Georgia, United States.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106181']
2232,33098953,The aortic root in repaired tetralogy of Fallot: Serial measurements and impact of losartan treatment.,"BACKGROUND


Aortic root dilatation is common in adults with repaired tetralogy of Fallot (rTOF) and might lead to aortic dissection. However, little is known on progression of aortic dilatation and the effect of pharmaceutical treatment. This study aims to determine factors associated with aortic growth and investigate effects of losartan.
METHODS AND RESULTS


We performed a prespecified analysis from the 1:1 randomized, double-blind REDEFINE trial. Aortic root diameters were measured at baseline and after 2.0 ± 0.3 years of follow-up using cardiovascular magnetic resonance (CMR) imaging. A total of 66 patients were included (68% men, age 40 ± 12 years, baseline aortic root 37 ± 6 mm, 32% aortic dilatation (>40 mm)). There was a trend towards slow aortic root growth (+0.6 ± 2.3 mm after two years, p = 0.06) (n = 60). LV stroke volume was the only factor associated with both a larger baseline aortic root (β: 0.09 mm/ml (95% C.I.:0.02, 0.15), p = 0.010) and with aortic growth during follow-up (β: 0.04 mm/ml (95% C.I.:0.005, 0.066), p = 0.024), after correction for age, sex, and body surface area using linear regression analysis. No treatment effect of losartan was found (p = 0.17).
CONCLUSIONS


Aortic root dilatation was present in about one-third of rTOF patients. A larger LV stroke volume was associated with both a larger baseline aortic root and ongoing growth. Our findings provide no arguments for lower aortic diameter thresholds for prophylactic surgery compared to the general population.",2020,"There was a trend towards slow aortic root growth (+0.6 ± 2.3 mm after two years, p = 0.06) (n = 60).","['adults with repaired tetralogy of Fallot (rTOF', 'A total of 66 patients were included (68% men, age 40\u202f±\u202f12\u202fyears, baseline aortic root 37\u202f±\u202f6\u202fmm, 32% aortic dilatation (>40\u202fmm']",['losartan'],"['Aortic root diameters', 'aortic growth', 'slow aortic root growth', 'LV stroke volume']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0039685', 'cui_str': 'Tetralogy of Fallot'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0549113', 'cui_str': 'Supraaortic valve area structure'}, {'cui': 'C0265004', 'cui_str': 'Dilatation of aorta'}, {'cui': 'C0450402', 'cui_str': '40mm'}]","[{'cui': 'C0126174', 'cui_str': 'Losartan'}]","[{'cui': 'C0549113', 'cui_str': 'Supraaortic valve area structure'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0003483', 'cui_str': 'Aortic'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0038455', 'cui_str': 'Stroke volume'}]",66.0,0.226436,"There was a trend towards slow aortic root growth (+0.6 ± 2.3 mm after two years, p = 0.06) (n = 60).","[{'ForeName': 'O I', 'Initials': 'OI', 'LastName': 'Woudstra', 'Affiliation': 'Heart Center; Department of Clinical and Experimental Cardiology, Amsterdam UMC, University of Amsterdam, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands; Department of Cardiology, University Medical Center Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ghanam', 'Affiliation': 'Heart Center; Department of Clinical and Experimental Cardiology, Amsterdam UMC, University of Amsterdam, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands.'}, {'ForeName': 'H W', 'Initials': 'HW', 'LastName': 'Vliegen', 'Affiliation': 'Department of Cardiology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'A P J', 'Initials': 'APJ', 'LastName': 'van Dijk', 'Affiliation': 'Department of Cardiology, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'van Melle', 'Affiliation': 'Department of Cardiology, Groningen University Medical Center, Groningen, the Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Groenink', 'Affiliation': 'Heart Center; Department of Clinical and Experimental Cardiology, Amsterdam UMC, University of Amsterdam, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands.'}, {'ForeName': 'F J', 'Initials': 'FJ', 'LastName': 'Meijboom', 'Affiliation': 'Department of Cardiology, University Medical Center Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'Post', 'Affiliation': 'Department of Cardiology, St. Antonius Hospital, Nieuwegein, the Netherlands.'}, {'ForeName': 'B J M', 'Initials': 'BJM', 'LastName': 'Mulder', 'Affiliation': 'Heart Center; Department of Clinical and Experimental Cardiology, Amsterdam UMC, University of Amsterdam, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands; Netherlands Heart Institute, Utrecht, the Netherlands.'}, {'ForeName': 'B J', 'Initials': 'BJ', 'LastName': 'Bouma', 'Affiliation': 'Heart Center; Department of Clinical and Experimental Cardiology, Amsterdam UMC, University of Amsterdam, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands.'}, {'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Bokma', 'Affiliation': 'Heart Center; Department of Clinical and Experimental Cardiology, Amsterdam UMC, University of Amsterdam, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands. Electronic address: j.p.bokma@amsterdamumc.nl.'}]",International journal of cardiology,['10.1016/j.ijcard.2020.10.037']
2233,33098995,Neoadjuvant paclitaxel/olaparib in comparison to paclitaxel/carboplatinum in patients with HER2-negative breast cancer and homologous recombination deficiency (GeparOLA study).,"BACKGROUND


The efficacy and toxicity of olaparib as combination therapy in early breast cancer (BC) patients with homologous recombinant deficiency (HRD score high and/or germline (g) or tumour (t) BRCA1/2 mutation) is not well described. GeparOLA (ClinicalTrials.gov, NCT02789332) investigated olaparib in combination with paclitaxel in HER2-negative early BC with HRD.
PATIENTS AND METHODS


Patients with untreated primary HER2-negative cT2-cT4a-d or cT1c with either cN+ or pNSLN+ or cT1c and TNBC or cT1c and Ki-67>20% BC with HRD were randomised either to paclitaxel (P) 80mg/m 2  weekly plus olaparib (O) 100mg twice daily for 12 weeks or P plus carboplatinum (Cb) AUC2 weekly for 12 weeks, both followed by epirubicin/cyclophosphamide (EC). Stratification factors were hormone receptor (HR) status (HR+ vs HR-) and age (<40 vs ≥40 years). The primary endpoint was pathological complete response (pCR; ypT0/is ypN0). A two-sided one group χ2-test was planned to exclude a pCR rate of ≤55% in PO-EC arm. Secondary endpoints were other pCR definitions, breast conservation rate, clinical/imaging response, tolerability and safety.
RESULTS


A total of 107 patients were randomised between 09/2016 and 07/2018; 106 (PO N=69; PCb N=37) started treatment. Median age was 47.0 years [range 25.0-71.0]; 36.2% had cT1, 61.0% cT2, 2.9% cT3, and 31.8% cN-positive tumours; G3: 86.8%; Ki-67>20%: 89.6%; TNBC: 72.6%; confirmed gBRCA1/2 mutation: 56.2%. pCR rate with PO was 55.1% (90%CI 44.5%-65.3%) vs PCb 48.6% (90%CI 34.3%-63.2%). Analysis for the stratified subgroups showed higher pCR rates with PO in the cohorts of patients <40 years and HR+ patients.
CONCLUSION


GeparOLA could not exclude a pCR rate of ≤55% in the PO arm. PO was significantly better tolerated and the combination merits further evaluation.",2020,"Analysis for the stratified subgroups showed higher pCR rates with PO in the cohorts of patients <40 years and HR+ patients.
","['patients with HER2-negative breast cancer and homologous recombination deficiency (GeparOLA study', 'Patients with untreated primary HER2-negative cT2-cT4a-d or cT1c with either cN+ or pNSLN+ or cT1c and TNBC or cT1c and Ki-67>20% BC with HRD', 'early breast cancer (BC) patients with homologous recombinant deficiency (HRD score high and/or germline (g) or tumour (t) BRCA1/2 mutation', 'A total of 107 patients were randomised between 09/2016 and 07/2018; 106 (PO N=69; PCb N=37) started treatment']","['paclitaxel/carboplatinum', 'pCR', 'paclitaxel', 'epirubicin/cyclophosphamide (EC', 'Neoadjuvant paclitaxel/olaparib', 'olaparib', 'paclitaxel (P) 80mg/m 2  weekly plus olaparib (O) 100mg twice daily for 12 weeks or P plus carboplatinum']","['rate with PO', 'pCR definitions, breast conservation rate, clinical/imaging response, tolerability and safety', 'pCR rate', 'pCR rates', 'hormone receptor (HR) status (HR+ vs HR-) and age ', 'pathological complete response ']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4087376', 'cui_str': 'HER2 negative'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0599773', 'cui_str': 'Homologous Recombination'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0032447', 'cui_str': 'Polychlorinated biphenyl'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C2316164', 'cui_str': 'olaparib'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4520026', 'cui_str': 'olaparib 100 MG'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0449443', 'cui_str': 'Receptor status'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}]",107.0,0.120765,"Analysis for the stratified subgroups showed higher pCR rates with PO in the cohorts of patients <40 years and HR+ patients.
","[{'ForeName': 'P A', 'Initials': 'PA', 'LastName': 'Fasching', 'Affiliation': 'Department of Gynecology and Obstetrics, University Hospital Erlangen, Comprehensive Cancer Center Erlangen-Nuermberg, National Center for Tumor Diseases, Erlangen, Germany.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Link', 'Affiliation': 'Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe, Universitätsklinikum Carl Gustav Carus Dresden, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Hauke', 'Affiliation': 'Center for Familial Breast and Ovarian Cancer, University of Cologne, Cologne, Germany.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Seither', 'Affiliation': 'German Breast Group, Neu-Isenburg, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Jackisch', 'Affiliation': 'Sana Klinikum Offenbach, Offenbach, Germany.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Klare', 'Affiliation': 'MediOnko-Institut GbR Berlin, Berlin, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Schmatloch', 'Affiliation': 'Elisabeth Krankenhaus Kassel, Kassel, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Hanusch', 'Affiliation': 'Rotkreuzklinikum München, Munich, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Huober', 'Affiliation': 'University Hospital Ulm, Ulm, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Stefek', 'Affiliation': 'Johanniter-Krankenhaus Genthin-Stendal, Stendal, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Seiler', 'Affiliation': 'German Breast Group, Neu-Isenburg, Germany.'}, {'ForeName': 'W D', 'Initials': 'WD', 'LastName': 'Schmitt', 'Affiliation': 'Institute of Pathology, Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Uleer', 'Affiliation': 'Gemeinschaftspraxis Hildesheim, Hildesheim, Germany.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Doering', 'Affiliation': 'Hämato-Onkologie im Medicum Bremen, Bremen, Germany.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Rhiem', 'Affiliation': 'Center for Familial Breast and Ovarian Cancer, University of Cologne, Cologne, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Schneeweiss', 'Affiliation': 'National Center for Tumor Diseases (NCT), Heidelberg University Hospital and German Cancer Research Center (DKFZ), Heidelberg, Germany.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Engels', 'Affiliation': 'Zentrum für Pathologie, Zytologie und Molekularpathologie Neuss, Neuss, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Denkert', 'Affiliation': 'Institute of Pathology, Philipps-Universität Marburg und University Hospital Marburg (UKGM), Marburg, Germany.'}, {'ForeName': 'R K', 'Initials': 'RK', 'LastName': 'Schmutzler', 'Affiliation': 'Center for Familial Breast and Ovarian Cancer, University of Cologne, Cologne, Germany.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Hahnen', 'Affiliation': 'Center for Familial Breast and Ovarian Cancer, University of Cologne, Cologne, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Untch', 'Affiliation': 'Helios-Klinikum Berlin-Buch, Berlin, Germany.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Burchardi', 'Affiliation': 'German Breast Group, Neu-Isenburg, Germany.'}, {'ForeName': 'J U', 'Initials': 'JU', 'LastName': 'Blohmer', 'Affiliation': 'Brustzentrum Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Loibl', 'Affiliation': 'German Breast Group, Neu-Isenburg, Germany. Electronic address: sibylle.loibl@gbg.de.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2020.10.471']
2234,33098997,Overall survival with 3 or 6 months of adjuvant chemotherapy in Italian TOSCA Phase 3 Randomized Trial.,"BACKGROUND


Oxaliplatin-based adjuvant chemotherapy is the standard treatment for high-risk colon cancer (CC). A shorter duration (3 months) can achieve a similar outcome (in terms of relapse-free survival [RFS]) to a longer duration. This study reports the overall survival (OS) analysis of the phase 3 Three or Six Colon Adjuvant (TOSCA) study. It assessed different adjuvant chemotherapy durations in patients with resected high-risk stage II and stage III CC.
MATERIAL AND METHODS


TOSCA was an open-label, phase III, multicentre, non-inferiority trial conducted in 130 Italian centres. Patients were randomly assigned, in a 1:1 ratio, to receive 3 months of standard doses of FOLFOX/CAPOX, or 6 months of FOLFOX/CAPOX. Patients with histologically confirmed high-risk stage II and III CC were included, with RFS being the primary endpoint. Overall survival was a secondary endpoint.
RESULTS


From June 2007 to March 2013, 3759 patients were accrued. At a median follow-up of 7 years, the hazard ratio (HR) for RFS of the 3 months vs. 6 months arms was 1.13 (95%CI 0.99-1.29, p for non-inferiority=0.380, p for superiority=0.068, crossing the non-inferiority limit of 1.20. This result did not allow us to reject the null hypothesis of the inferiority of the 3 months arm. The HR for OS of the 3 months vs. 6 months arms was 1.09 (95%CI 0.93-1.26, p for superiority=0.288). At the last follow-up analysis, the absolute OS difference between arms was less than 1%.
CONCLUSIONS


The present analysis of the TOSCA trial does not indicate any significant difference in OS between the treatment groups. The extra benefit provided by the longer treatment should be balanced against the extra toxicity of more prolonged therapy. The trial is registered with ClinicalTrials.gov, registration number: NCT0064660.",2020,A shorter duration (3 months) can achieve a similar outcome (in terms of relapse-free survival [RFS]) to a longer duration.,"['Patients with histologically confirmed high-risk stage II and III CC', '130 Italian centres', 'patients with resected high-risk stage II and stage III CC', 'From June 2007 to March 2013, 3759 patients were accrued', 'high-risk colon cancer (CC']","['adjuvant chemotherapy', 'FOLFOX/CAPOX, or 6 months of FOLFOX/CAPOX', 'Oxaliplatin-based adjuvant chemotherapy']","['overall survival (OS', 'Overall survival', 'absolute OS difference', 'hazard ratio (HR) for RFS', 'OS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0022275', 'cui_str': 'Italian language'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0007102', 'cui_str': 'Malignant tumor of colon'}]","[{'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0341703', 'cui_str': 'Adult Fanconi syndrome'}]",3759.0,0.310107,A shorter duration (3 months) can achieve a similar outcome (in terms of relapse-free survival [RFS]) to a longer duration.,"[{'ForeName': 'Fausto', 'Initials': 'F', 'LastName': 'Petrelli', 'Affiliation': 'Medical Oncology Unit, Treviglio - Caravaggio Hospital, Treviglio (BG). Electronic address: faupe@libero.it.'}, {'ForeName': 'Eliana', 'Initials': 'E', 'LastName': 'Rulli', 'Affiliation': 'Laboratory of Methodology for Clinical Research , Istituto di Ricerche Farmacologiche Mario Negri IRCCS , Milano.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Labianca', 'Affiliation': 'Cancer Center ASST Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Lonardi', 'Affiliation': 'Medical Oncology Unit 1, Istituto Oncologico Veneto-IRCCS, Padova.'}, {'ForeName': 'Gerardo', 'Initials': 'G', 'LastName': 'Rosati', 'Affiliation': 'Medical Oncology Unit, Ospedale San Carlo, Potenza.'}, {'ForeName': 'Katia', 'Initials': 'K', 'LastName': 'Dotti', 'Affiliation': 'Medical Oncology Department, Fondazione IRCCS Istituto Nazionale Tumori, Milano.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Ronzoni', 'Affiliation': 'Medical Oncology Unit, Ospedale San Raffaele-IRCCS, Milano.'}, {'ForeName': 'Nicoletta', 'Initials': 'N', 'LastName': 'Pella', 'Affiliation': 'Medical Oncology Unit, Azienda Ospedaliero Universitaria Santa Maria della Misericordia, Udine.'}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Pusceddu', 'Affiliation': 'Medical Oncology, University Hospital and University of Cagliari, Cagliari.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Banzi', 'Affiliation': 'Medical Oncology Unit, AUSL-IRCCS, Reggio Emilia.'}, {'ForeName': 'Maria Giulia', 'Initials': 'MG', 'LastName': 'Zampino', 'Affiliation': 'Division of Gastrointestinal Medical Oncology and Neuroendocrine Tumors, IRCCS, Milano.'}, {'ForeName': 'Modena', 'Initials': 'M', 'LastName': 'Yasmina', 'Affiliation': 'Medical Oncology Unit, Rovigo Hospital, Rovigo.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Marchetti', 'Affiliation': ""Medical Oncology Unit, Sant'Andrea Hospital, Sapienza University of Rome and IDI-IRCCS, Roma.""}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Cantore', 'Affiliation': 'Medical Oncology Unit, ASST Mantova, Mantova.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Zaniboni', 'Affiliation': 'Medical Oncology Unit, Fondazione Poliambulanza, Brescia.'}, {'ForeName': 'Lorenza', 'Initials': 'L', 'LastName': 'Rimassa', 'Affiliation': 'Medical Oncology and Hematology Unit, Humanitas Cancer Center, Humanitas Clinical and Research Center-IRCSS, Rozzano (MI); Department of Biomedical Sciences, Humanitas University, Pieve Emanuele (MI).'}, {'ForeName': 'Libero', 'Initials': 'L', 'LastName': 'Ciuffreda', 'Affiliation': 'Medical Oncology Unit, Azienda Ospedaliero Universitaria San Giovanni Battista, Molinette, Torino.'}, {'ForeName': 'Daris', 'Initials': 'D', 'LastName': 'Ferrari', 'Affiliation': 'Medical Oncology Unit, Azienda Ospedaliera San Paolo, Milano.'}, {'ForeName': 'Vittorina', 'Initials': 'V', 'LastName': 'Zagonel', 'Affiliation': 'Medical Oncology Unit 1, Istituto Oncologico Veneto-IRCCS, Padova.'}, {'ForeName': 'Evaristo', 'Initials': 'E', 'LastName': 'Maiello', 'Affiliation': 'Medical Oncology Unit, Hospital Casa Sollievo della Sofferenza-IRCCS, San Giovanni Rotondo.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Sobrero', 'Affiliation': 'Medical Oncology Unit, IRCCS San Martino-IST, Genova.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2020.10.477']
2235,33099015,"Intervention to promote physical activation and improve sleep and response feeding in infants for preventing obesity early in life, the baby-act trial: Rationale and design.","Infant obesity is increasing in the US, particularly among Hispanics. Rapid weight gain during infancy increases the risk of obesity later in life and could be prevented through multi-modal interventions addressing multiple risk factors through population-level programs.
OBJECTIVES


1) determine the extent to which the intervention, compared with the usual care control condition, improves healthy weight gain and specific behaviors (physical activity, sleep, diet) in the first year of life and 2) evaluate the cost of the intervention as a modification of the current WIC standard of care.
METHODS


The lifestyle intervention focuses on age-appropriate infant physical activation, healthy sleep and sedentary patterns, and response feeding, by improving parenting skills delivered through a combination of technology (web-platform and text messages) and phone counseling. It is being tested among caregivers of infant participants of the Puerto Rico WIC program through a cluster-randomized controlled trial in 14 WIC clinics in San Juan starting in pregnancy until the infant is 12 months of age. The main outcome is infant rate of weight gain at 12 months; secondary outcomes include objectively measured hours of infant movement, sedentary behaviors and sleep, diet quality score and response feeding behaviors. We are also recording fees, time and personnel involved in the intervention development, maintenance and dissemination.
CONCLUSIONS


If successful, the intervention could be incorporated as a 'best practice' through WIC policy as a means to strengthen obesity prevention efforts to improve minority health and eliminate health disparities among Hispanics and possibly other at-risk groups beyond the childhood period. Clinicaltrials.gov registration: NCT03517891.",2020,"OBJECTIVES


1) determine the extent to which the intervention, compared with the usual care control condition, improves healthy weight gain and specific behaviors (physical activity, sleep, diet) in the first year of life and 2) evaluate the cost of the intervention as a modification of the current WIC standard of care.
",['caregivers of infant participants of the Puerto Rico WIC program through a cluster-randomized controlled trial in 14 WIC clinics in San Juan starting in pregnancy until the infant is 12\u202fmonths of age'],"['healthy sleep and sedentary patterns, and response feeding, by improving parenting skills delivered through a combination of technology (web-platform and text messages) and phone counseling']","['infant rate of weight gain at 12\u202fmonths; secondary outcomes include objectively measured hours of infant movement, sedentary behaviors and sleep, diet quality score and response feeding behaviors', 'Rapid weight gain', 'healthy weight gain and specific behaviors (physical activity, sleep, diet']","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0034044', 'cui_str': 'Puerto Rico'}, {'cui': 'C4277516', 'cui_str': 'Special Supplemental Nutrition Program for Women, Infants, and Children (U.S.)'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C1532253', 'cui_str': 'Sedentary lifestyle'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",14.0,0.0627379,"OBJECTIVES


1) determine the extent to which the intervention, compared with the usual care control condition, improves healthy weight gain and specific behaviors (physical activity, sleep, diet) in the first year of life and 2) evaluate the cost of the intervention as a modification of the current WIC standard of care.
","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Campos', 'Affiliation': 'Dental and Craniofacial Genomics Core, Endocrinology Section School of Medicine, University of Puerto Rico, PO Box 365067, San Juan 00936-5067, Puerto Rico. Electronic address: maribel.campos@upr.edu.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Pomeroy', 'Affiliation': 'Clinical Research Center, Marshfield Clinic Research Institute, Marshfield Clinic Health System, Marshfield, WI, USA. Electronic address: pomeroyj@marshfieldclinic.org.'}, {'ForeName': 'M H', 'Initials': 'MH', 'LastName': 'Mays', 'Affiliation': 'Biomedical Informatics Core, Puerto Rico Clinical and Translational Research Consortium, Puerto Rico. Electronic address: mary.mays@upr.edu.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Lopez', 'Affiliation': 'Sports and Leisure Management program and Adapted Physical Education program, School of Education, Metropolitan University, Puerto Rico. Electronic address: lopeza1@suagm.edu.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Palacios', 'Affiliation': 'Dietetics and Nutrition Department, Robert Stempel College of Public Health & Social Work, Florida International University, USA. Electronic address: cristina.palacios@fiu.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106185']
2236,33099054,"A randomised controlled trial of metacognitive training for psychosis, depression, and belief flexibility.","BACKGROUND


Metacognitive training (MCT) has been shown to be effective in reducing psychotic symptoms, including delusions. However, less is known on whether MCT, or its specific modules, are effective in ameliorating reasoning biases e.g. belief flexibility. As inflexibility in appraisal has been associated with psychosis and major depressive disorder (MDD), this study examined the efficacy of a 4-session MCT on delusions, depression, and belief flexibility, in two clinical groups (Psychosis and Depression).
METHODS


This study adopted a single-blind randomised controlled design, with patients with schizophrenia spectrum disorders (and delusions) and patients with MDD being randomised, respectively, into the MCT condition or a treatment-as-usual (TAU) condition. The MCT intervention consisted of specific modules targeting belief flexibility. Participants were assessed before and after treatment, and at 1- and 6-month follow-ups.
RESULTS


Among the 113 participants, 27 patients with psychosis and 29 patients with MDD attended MCT. There were significant improvements in psychotic symptoms, especially delusions, for the Psychosis group, and in depressive symptoms for the MDD group. Symptom improvements following MCT were of large effect sizes, were significantly greater than TAU, and persisted at 6-month. Belief flexibility also improved in both groups, although changes were smaller in size and were not significantly greater than TAU.
LIMITATIONS


An active control condition was not included.
CONCLUSIONS


This study demonstrated large and stable symptom reductions in delusions and depression, and smaller (yet stable) improvement in belief flexibility across groups, following a 4-session MCT, carrying implications for transdiagnostic process-based interventions and their mechanisms of change.",2020,"There were significant improvements in psychotic symptoms, especially delusions, for the Psychosis group, and in depressive symptoms for the MDD group.","['patients with schizophrenia spectrum disorders (and delusions) and patients with MDD being randomised, respectively, into the MCT condition or a treatment-as-usual (TAU) condition', '113 participants, 27 patients with psychosis and 29 patients with MDD attended MCT']","['MCT', 'Metacognitive training (MCT', 'metacognitive training']","['Belief flexibility', 'depressive symptoms', 'psychotic symptoms, especially delusions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0011253', 'cui_str': 'Delusions'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C1456498', 'cui_str': 'Attended'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0871189', 'cui_str': 'Psychotic symptom'}, {'cui': 'C0011253', 'cui_str': 'Delusions'}]",27.0,0.0534335,"There were significant improvements in psychotic symptoms, especially delusions, for the Psychosis group, and in depressive symptoms for the MDD group.","[{'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Ho-Wai So', 'Affiliation': 'Department of Psychology, The Chinese University of Hong Kong, 3/F Wong Foo Yuan Building, Shatin, N.T., Hong Kong SAR. Electronic address: shwso@psy.cuhk.edu.hk.'}, {'ForeName': 'Gloria', 'Initials': 'G', 'LastName': 'Hoi-Kei Chan', 'Affiliation': 'Alice Ho Miu Ling Nethersole Hospital, 11 Chuen On Road, Tai Po, N.T., Hong Kong SAR.'}, {'ForeName': 'Cheris', 'Initials': 'C', 'LastName': 'Kit-Wa Wong', 'Affiliation': 'Tai Po Hospital, 9 Chuen On Road, Tai Po, N.T., Hong Kong SAR.'}, {'ForeName': 'Edgar', 'Initials': 'E', 'LastName': 'Wing-Ka Ching', 'Affiliation': 'Castle Peak Hospital, 15 Tsing Chung Koon Road, Tuen Mun, Hong Kong SAR.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Sze-Wai Lee', 'Affiliation': 'Castle Peak Hospital, 15 Tsing Chung Koon Road, Tuen Mun, Hong Kong SAR.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Chi-Wing Wong', 'Affiliation': 'Department of Psychology, The Chinese University of Hong Kong, 3/F Wong Foo Yuan Building, Shatin, N.T., Hong Kong SAR.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Zhu', 'Affiliation': 'Department of Psychology, The Chinese University of Hong Kong, 3/F Wong Foo Yuan Building, Shatin, N.T., Hong Kong SAR.'}, {'ForeName': 'Xiaoqi', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'Department of Psychology, The Chinese University of Hong Kong, 3/F Wong Foo Yuan Building, Shatin, N.T., Hong Kong SAR.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Kin-Hei Chung', 'Affiliation': 'Department of Psychology, The Chinese University of Hong Kong, 3/F Wong Foo Yuan Building, Shatin, N.T., Hong Kong SAR.'}, {'ForeName': 'Alyse Yu', 'Initials': 'AY', 'LastName': 'Hung', 'Affiliation': 'Department of Psychology, The Chinese University of Hong Kong, 3/F Wong Foo Yuan Building, Shatin, N.T., Hong Kong SAR.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Oi-Yin Wong', 'Affiliation': 'Castle Peak Hospital, 15 Tsing Chung Koon Road, Tuen Mun, Hong Kong SAR.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Sau-Man Chan', 'Affiliation': 'Department of Psychiatry, The Chinese University of Hong Kong, Tai Po Hospital, 9 Chuen On Road, Tai Po, N.T., Hong Kong SAR.'}]",Journal of affective disorders,['10.1016/j.jad.2020.09.126']
2237,33095965,Comparison of External Jugular Vein based surface landmark approach and Ultrasound guided approach for Internal Jugular Venous cannulation: A randomized cross over clinical trial.,"BACKGROUND AND OBJECTIVE


Historically, landmark techniques for central venous access through the internal jugular vein (IJV) have yielded a lesser success rate and higher complication rate than the ultrasound (US) guided approach. The purpose of this study to assess the success and safety of a novel external jugular vein (EJV) based LM (EJV-LM) approach compared to the real-time US-guided approach for central venous access through the internal jugular vein.
METHODS


This was a prospective, randomized, cross over trial performed in patients during elective cardiac and non-cardiac surgery. Each resident randomly inserted a central venous catheter using EJV-LM approach and real-time US-guided approach. The primary outcome was first attempt success. Secondary outcomes included overall success rate, number of puncture attempts, cannulation time, hematoma and mechanical complications.
RESULTS


A total of 188 patients were randomly assigned to the EJV-LM and US groups. The demographic characteristics of the groups were comparable. The first attempt success was not different between EJV-LM and US-guided technique {79.8%; (95% CI: 70.2-87.4) vs 89.4% (95% CI 81.3-94.8); p=0.06}. The overall success rate was 100% with both techniques. There were no differences in the number of puncture attempts with introduce needle {1(1-3) vs 1(1-2); p=0.07). Cannulation time was longer in the EJV-LM group compared to the US group (58.11±6.6 vs. 44.27±5.28 seconds; P=0.0001). EJV-LM technique was associated to a higher occurrence of overall complications compared to the US technique {12.8% (95% CI :6.7- 21.2) vs 4.2% (95% CI:1.1-10.5); P=0.03}. No major mechanical complications were observed with either technique.
CONCLUSIONS


In patients with non-distorted neck anatomy and a visible EJV, IJV catheterization using the EJV-based LM approach and standard US-guided technique yielded similar first attempt and overall success rates. Cannulation time was longer and complications occurred more frequently in the EJV-based LM compared to the standard US-guided technique.",2020,Cannulation time was longer and complications occurred more frequently in the EJV-based LM compared to the standard US-guided technique.,"['patients during elective cardiac and non-cardiac surgery', 'A total of 188 patients', 'Internal Jugular Venous cannulation']","['central venous catheter using EJV-LM approach and real-time US-guided approach', 'EJV-based LM', 'novel external jugular vein (EJV) based LM (EJV-LM) approach', 'External Jugular Vein based surface landmark approach and Ultrasound guided approach', 'EJV-LM']","['Cannulation time', 'overall complications', 'overall success rate, number of puncture attempts, cannulation time, hematoma and mechanical complications', 'overall success rate', 'major mechanical complications', 'number of puncture attempts']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0398266', 'cui_str': 'Catheterization of vein'}]","[{'cui': 'C1145640', 'cui_str': 'Central venous catheter'}, {'cui': 'C0226543', 'cui_str': 'Structure of external jugular vein'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205148', 'cui_str': 'Surface'}]","[{'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",188.0,0.094945,Cannulation time was longer and complications occurred more frequently in the EJV-based LM compared to the standard US-guided technique.,"[{'ForeName': 'Arunagiri', 'Initials': 'A', 'LastName': 'Vinayagamurugan', 'Affiliation': 'Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India.'}, {'ForeName': 'Ashok Shankar', 'Initials': 'AS', 'LastName': 'Badhe', 'Affiliation': 'Jawaharlal Institute of Postgraduate Education and Research, Puducherry, India.'}, {'ForeName': 'Ajay Kumar', 'Initials': 'AK', 'LastName': 'Jha', 'Affiliation': 'Jawaharlal Institute of Postgraduate Education and Research, Puducherry, India.'}]",International journal of clinical practice,['10.1111/ijcp.13783']
2238,33095994,Transmission of Oscillatory Volumes into the Preterm Lung during Noninvasive High-Frequency Ventilation.,"RATIONALE


There is increasing evidence for a clinical benefit of noninvasive high-frequency oscillatory ventilation (nHFOV) in preterm infants. However, it is still unknown whether the generated oscillations are effectively transmitted to the alveoli.
OBJECTIVES


To assess magnitude and regional distribution of oscillatory volumes (V Osc ) at the lung level.
METHODS


In 30 prone preterm infants enrolled in a randomized crossover trial comparing nHFOV with nasal continuous positive airway pressure (nCPAP), electrical impedance tomography (EIT) recordings were performed. During nHFOV, the smallest amplitude to achieve visible chest wall vibration was used, and the frequency was set at 8 hertz (Hz).
MEASUREMENTS AND MAIN RESULTS


Thirty consecutive breaths during artefact-free tidal ventilation were extracted for each of the 228 EIT recordings. After application of corresponding frequency filters, tidal volumes (V T ) and V Osc  were calculated. There was a signal at 8 and 16 Hz during nHFOV which was not detectable during nCPAP, corresponding to the set oscillatory frequency and its second harmonic. During nHFOV, the mean (SD) V Osc /V T  ratio was 0.20 (0.13). Oscillations were more likely to be transmitted to the non-gravity-dependent [mean difference (95% CI): 0.041 (0.025 to 0.058); p<0.001] and right-sided lung [mean difference (95% CI): 0.040 (0.019 to 0.061); p<0.001] when compared with spontaneous V T .
CONCLUSIONS


In preterm infants, V Osc  during nHFOV are transmitted to the lung. Compared with the regional distribution of tidal breaths, oscillations preferentially reach the right and non-gravity-dependent lung. These data increase our understanding of the physiological processes underpinning nHFOV and may lead to further refinement of this novel technique.",2020,"Oscillations were more likely to be transmitted to the non-gravity-dependent [mean difference (95% CI): 0.041 (0.025 to 0.058); p<0.001] and right-sided lung [mean difference (95% CI): 0.040 (0.019 to 0.061); p<0.001] when compared with spontaneous V T .
","['30 prone preterm infants enrolled', 'preterm infants']","['noninvasive high-frequency oscillatory ventilation (nHFOV', 'nHFOV with nasal continuous positive airway pressure (nCPAP), electrical impedance tomography (EIT) recordings']",['tidal volumes (V T ) and V Osc'],"[{'cui': 'C0033422', 'cui_str': 'Prone body position'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}]","[{'cui': 'C0419017', 'cui_str': 'High frequency oscillatory ventilation'}, {'cui': 'C1258045', 'cui_str': 'nCPAP Ventilation'}, {'cui': 'C0162537', 'cui_str': 'Impedance'}, {'cui': 'C0040395', 'cui_str': 'Diagnostic tomography'}]","[{'cui': 'C0040210', 'cui_str': 'Tidal volume'}]",30.0,0.0586295,"Oscillations were more likely to be transmitted to the non-gravity-dependent [mean difference (95% CI): 0.041 (0.025 to 0.058); p<0.001] and right-sided lung [mean difference (95% CI): 0.040 (0.019 to 0.061); p<0.001] when compared with spontaneous V T .
","[{'ForeName': 'Vincent D', 'Initials': 'VD', 'LastName': 'Gaertner', 'Affiliation': 'University Hospital Zurich, 27243, Newborn Research, Department of Neonatology, Zurich, Switzerland.'}, {'ForeName': 'Andreas D', 'Initials': 'AD', 'LastName': 'Waldmann', 'Affiliation': 'Rostock University Medical Center, 39071, Department of Anesthesiology and Intensive Care Medicine, Rostock, Germany.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Davis', 'Affiliation': ""Royal Women's Hospital Newborn Research Centre, 568375, Parkville, Victoria, Australia.""}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Bassler', 'Affiliation': 'University Hospital Zurich, 27243, Newborn Research, Department of Neonatology, Zurich, Switzerland.'}, {'ForeName': 'Laila', 'Initials': 'L', 'LastName': 'Springer', 'Affiliation': 'University Hospitals Tubingen, 27203, Department of Neonatology, Tubingen, Germany.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Thomson', 'Affiliation': 'The University of Melbourne, 2281, Melbourne, Victoria, Australia.'}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Tingay', 'Affiliation': 'The University of Melbourne, 2281, Melbourne, Victoria, Australia.'}, {'ForeName': 'Christoph M', 'Initials': 'CM', 'LastName': 'Rüegger', 'Affiliation': 'University Hospital Zurich, 27243, Newborn Research, Department of Neonatology, Zürich, Switzerland; christoph.rueegger@usz.ch.'}]",American journal of respiratory and critical care medicine,['10.1164/rccm.202007-2701OC']
2239,33096006,Women and men with coronary heart disease respond similarly to different aerobic exercise training modalities: a pooled analysis of prospective randomized trials.,"We aimed to compare cardiopulmonary exercise test (CPET) parameters, cardiac adaptations and proportion of responders after different aerobic training programs amongst women and men with coronary heart disease (CHD). Patients with CHD were evaluated with a CPET and echocardiography before and after 3 month of aerobic exercise training. V̇O2 peak exercise training response was assessed according to the median V̇O2 peak change post vs. pre-training in the whole cohort (stratification non-/low-responders (NLRes) vs. high-responders) and normalized for lean body mass (LBM). Eighty three CHD patients were included (19 women, 64 men), (27 patients with interval, 19 with continuous and 37 with a combination). V̇O2 peak, peak work load normalized for LBM, pulmonary (i.e. ventilation and OUES) and O2 pulse were significantly lower in women vs. men.These parameters improved similarly with training in both sexes (p<0.05). There were no differences in the proportion of NLRes among women and men with CHD (7/19 or 37% vs. 35/64 or 55%, p=0.1719). Left ventricular ejection fraction and mean peak early diastolic mitral annulus velocity improved similarly with training in both sexes (p<0.05). Women and men with CHD have a similar exercise training response regarding key CPET, echocardiographic parameters. The proportion of responders is similar. ClinicalTrials.gov: NCT03414996, NCT02048696, NCT03443193 Novelty: Cardiopulmonary adaptations to exercise training is similar among CHD men and women Proportion of V̇O2 peak non-/low-/high-responders is similar in CHD men and women LV systolic (LVEF) and diastolic (e') function improved similarly after exercise training in CHD men and women.",2020,Left ventricular ejection fraction and mean peak early diastolic mitral annulus velocity improved similarly with training in both sexes (p<0.05).,"['CHD men and women', 'Patients with CHD', 'Women and men with coronary heart disease respond similarly to different', 'Women and men with CHD', 'Eighty three CHD patients were included (19 women, 64 men), (27 patients with interval, 19 with continuous and 37 with a combination', 'women and men with coronary heart disease (CHD']","['aerobic exercise training modalities', 'aerobic training programs', 'exercise training', 'cardiopulmonary exercise test (CPET', 'aerobic exercise training']","[""women LV systolic (LVEF) and diastolic (e') function"", 'V̇O2 peak, peak work load normalized for LBM, pulmonary (i.e. ventilation and OUES) and O2 pulse', 'Left ventricular ejection fraction and mean peak early diastolic mitral annulus velocity', 'V̇O2 peak exercise training response', 'proportion of NLRes']","[{'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517888', 'cui_str': '83'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C2959886', 'cui_str': 'Cardiopulmonary exercise test'}]","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0225947', 'cui_str': 'Structure of anulus fibrosus of mitral orifice'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]",83.0,0.0452063,Left ventricular ejection fraction and mean peak early diastolic mitral annulus velocity improved similarly with training in both sexes (p<0.05).,"[{'ForeName': 'Lukas Daniel', 'Initials': 'LD', 'LastName': 'Trachsel', 'Affiliation': 'University Clinic for Cardiology, Inselspital, Bern University Hospital, University of Bern, Switzerland, Bern, Switzerland; lukas.trachsel@hin.ch.'}, {'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Boidin', 'Affiliation': 'Institut De Cardiologie de Montreal, 25465, Centre ÉPIC, Montreal, Quebec, Canada; maxime.boidin@umontreal.ca.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Henri', 'Affiliation': 'Montreal Heart Institute, 25465, Montreal, Quebec, Canada, H1T 1C8; christine.henri@umontreal.ca.'}, {'ForeName': 'Annik', 'Initials': 'A', 'LastName': 'Fortier', 'Affiliation': 'Montreal Heart Institute, 25465, Montreal, Quebec, Canada; annik.fortier@mhicc.org.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Lalongé', 'Affiliation': 'University of Montreal, 5622, Montreal, Canada, H3C 3J7; julie.lalonge@icm-mhi.org.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Juneau', 'Affiliation': 'Montreal Heart Institute, 5000 Belanger Street, Montreal, Quebec, Canada, H1T 1C8; martin.juneau@icm-mhi.org.'}, {'ForeName': 'Anil', 'Initials': 'A', 'LastName': 'Nigam', 'Affiliation': 'Montreal Heart Institute, 5000 Belanger Street, Montreal, Quebec, Canada, H1T 1C8; anil.nigam@icm-mhi.org.'}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Gayda', 'Affiliation': 'Montreal Heart Institute, Cardiovascular Prevention and Rehabilitation Centre, 5055 St Zotique street East, Montreal, Quebec, Canada, H1T1N6; mathieu.gayda@icm-mhi.org.'}]","Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme",['10.1139/apnm-2020-0650']
2240,33096027,Pembrolizumab with or without radiotherapy for metastatic non-small-cell lung cancer: a pooled analysis of two randomised trials.,"BACKGROUND


Radiotherapy might augment systemic antitumoral responses to immunotherapy. In the PEMBRO-RT (phase 2) and MDACC (phase 1/2) trials, patients with metastatic non-small-cell lung cancer were randomly allocated immunotherapy (pembrolizumab) with or without radiotherapy. When the trials were analysed individually, a potential benefit was noted in the combination treatment arm. However, owing to the small sample size of each trial, differences in response rates and outcomes were not statistically significant but remained clinically notable. We therefore did a pooled analysis to infer whether radiotherapy improves responses to immunotherapy in patients with metastatic non-small-cell lung cancer.
METHODS


Inclusion criteria for the PEMBRO-RT and MDACC trials were patients (aged ≥18 years) with metastatic non-small-cell lung cancer and at least one unirradiated lesion to monitor for out-of-field response. In the PEMBRO-RT trial, patients had previously received chemotherapy, whereas in the MDACC trial, patients could be either previously treated or newly diagnosed. Patients in both trials were immunotherapy-naive. In the PEMBRO-RT trial, patients were randomly assigned (1:1) and stratified by smoking status (<10 vs ≥10 pack-years). In the MDACC trial, patients were entered into one of two cohorts based on radiotherapy schedule feasibility and randomly assigned (1:1). Because of the nature of the intervention in the combination treatment arm, blinding to radiotherapy was not feasible in either trial. Pembrolizumab was administered intravenously (200 mg every 3 weeks) with or without radiotherapy in both trials. In the PEMBRO-RT trial, the first dose of pembrolizumab was given sequentially less than 1 week after the last dose of radiotherapy (24 Gy in three fractions), whereas in the MDACC trial, pembrolizumab was given concurrently with the first dose of radiotherapy (50 Gy in four fractions or 45 Gy in 15 fractions). Only unirradiated lesions were measured for response. The endpoints for this pooled analysis were best out-of-field (abscopal) response rate (ARR), best abscopal disease control rate (ACR), ARR at 12 weeks, ACR at 12 weeks, progression-free survival, and overall survival. The intention-to-treat populations from both trials were included in analyses. The PEMBRO-RT trial (NCT02492568) and the MDACC trial (NCT02444741) are registered with ClinicalTrials.gov.
FINDINGS


Overall, 148 patients were included in the pooled analysis, 76 of whom had been assigned pembrolizumab and 72 who had been assigned pembrolizumab plus radiotherapy. Median follow-up for all patients was 33 months (IQR 32·4-33·6). 124 (84%) of 148 patients had non-squamous histological features and 111 (75%) had previously received chemotherapy. Baseline variables did not differ between treatment groups, including PD-L1 status and metastatic disease volume. The most frequently irradiated sites were lung metastases (28 of 72 [39%]), intrathoracic lymph nodes (15 of 72 [21%]), and lung primary disease (12 of 72 [17%]). Best ARR was 19·7% (15 of 76) with pembrolizumab versus 41·7% (30 of 72) with pembrolizumab plus radiotherapy (odds ratio [OR] 2·96, 95% CI 1·42-6·20; p=0·0039), and best ACR was 43·4% (33 of 76) with pembrolizumab versus 65·3% (47 of 72) with pembrolizumab plus radiotherapy (2·51, 1·28-4·91; p=0·0071). Median progression-free survival was 4·4 months (IQR 2·9-5·9) with pembrolizumab alone versus 9·0 months (6·8-11·2) with pembrolizumab plus radiotherapy (hazard ratio [HR] 0·67, 95% CI 0·45-0·99; p=0·045), and median overall survival was 8·7 months (6·4-11·0) with pembrolizumab versus 19·2 months (14·6-23·8) with pembrolizumab plus radiotherapy (0·67, 0·54-0·84; p=0·0004). No new safety concerns were noted in the pooled analysis.
INTERPRETATION


Adding radiotherapy to pembrolizumab immunotherapy significantly increased responses and outcomes in patients with metastatic non-small-cell lung cancer. These results warrant validation in a randomised phase 3 trial.
FUNDING


Merck Sharp & Dohme.",2020,"The most frequently irradiated sites were lung metastases (28 of 72 [39%]), intrathoracic lymph nodes (15 of 72 [21%]), and lung primary disease (12 of 72 [17%]).","['metastatic non-small-cell lung cancer', 'patients with metastatic non-small-cell lung cancer', '148 patients were included in the pooled analysis, 76 of whom had been assigned pembrolizumab and 72 who had been assigned', 'Inclusion criteria for the PEMBRO-RT and MDACC trials were patients (aged ≥18 years) with metastatic non-small-cell lung cancer and at least one unirradiated lesion to monitor for out-of-field response', '124 (84%) of 148 patients had non-squamous histological features and 111 (75%) had previously received']","['pembrolizumab', 'Pembrolizumab with or without radiotherapy', 'immunotherapy (pembrolizumab) with or without radiotherapy', 'pembrolizumab plus radiotherapy', 'pembrolizumab immunotherapy', 'MDACC', 'Pembrolizumab', 'radiotherapy', 'chemotherapy']","['PD-L1 status and metastatic disease volume', 'lung metastases', 'intrathoracic lymph nodes', 'median overall survival', 'of-field (abscopal) response rate (ARR), best abscopal disease control rate (ACR), ARR at 12 weeks, ACR at 12 weeks, progression-free survival, and overall survival', 'Median progression-free survival']","[{'cui': 'C0278987', 'cui_str': 'Metastatic non-small cell lung cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C4517538', 'cui_str': '111'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0153676', 'cui_str': 'Secondary malignant neoplasm of lung'}, {'cui': 'C0595836', 'cui_str': 'Intrathoracic route'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",148.0,0.558171,"The most frequently irradiated sites were lung metastases (28 of 72 [39%]), intrathoracic lymph nodes (15 of 72 [21%]), and lung primary disease (12 of 72 [17%]).","[{'ForeName': 'Willemijn S M E', 'Initials': 'WSME', 'LastName': 'Theelen', 'Affiliation': 'Department of Thoracic Oncology, The Netherlands Cancer Institute, Amsterdam, Netherlands.'}, {'ForeName': 'Dawei', 'Initials': 'D', 'LastName': 'Chen', 'Affiliation': 'Department of Radiation Oncology, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, Shandong, China. Electronic address: chendawei0505@yahoo.com.'}, {'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Verma', 'Affiliation': 'Department of Radiation Oncology, The University of Texas M D Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Brian P', 'Initials': 'BP', 'LastName': 'Hobbs', 'Affiliation': 'Quantitative Health Sciences, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Heike M U', 'Initials': 'HMU', 'LastName': 'Peulen', 'Affiliation': 'Department of Radiation Oncology, The Netherlands Cancer Institute, Amsterdam, Netherlands; Department of Radiation Oncology, Catharina Hospital, Eindhoven, Netherlands.'}, {'ForeName': 'Joachim G J V', 'Initials': 'JGJV', 'LastName': 'Aerts', 'Affiliation': 'Department of Pulmonology, Erasmus Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Idris', 'Initials': 'I', 'LastName': 'Bahce', 'Affiliation': 'Department of Pulmonology, VU Medical Center, Amsterdam, Netherlands.'}, {'ForeName': 'Anna Larissa N', 'Initials': 'ALN', 'LastName': 'Niemeijer', 'Affiliation': 'Department of Pulmonology, VU Medical Center, Amsterdam, Netherlands.'}, {'ForeName': 'Joe Y', 'Initials': 'JY', 'LastName': 'Chang', 'Affiliation': 'Department of Radiation Oncology, The University of Texas M D Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Patricia M', 'Initials': 'PM', 'LastName': 'de Groot', 'Affiliation': 'Department of Diagnostic Radiology, The University of Texas M D Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Quynh-Nhu', 'Initials': 'QN', 'LastName': 'Nguyen', 'Affiliation': 'Department of Radiation Oncology, The University of Texas M D Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Nathan I', 'Initials': 'NI', 'LastName': 'Comeaux', 'Affiliation': 'Department of Radiation Oncology, The University of Texas M D Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'George R', 'Initials': 'GR', 'LastName': 'Simon', 'Affiliation': 'Department of Thoracic/Head & Neck Oncology, The University of Texas M D Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Ferdinandos', 'Initials': 'F', 'LastName': 'Skoulidis', 'Affiliation': 'Department of Radiation Oncology, The University of Texas M D Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Steven H', 'Initials': 'SH', 'LastName': 'Lin', 'Affiliation': 'Department of Radiation Oncology, The University of Texas M D Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Kewen', 'Initials': 'K', 'LastName': 'He', 'Affiliation': 'Department of Radiation Oncology, The University of Texas M D Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Roshal', 'Initials': 'R', 'LastName': 'Patel', 'Affiliation': 'Department of Radiation Oncology, The University of Texas M D Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Heymach', 'Affiliation': 'Department of Thoracic/Head & Neck Oncology, The University of Texas M D Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Baas', 'Affiliation': 'Department of Thoracic Oncology, The Netherlands Cancer Institute, Amsterdam, Netherlands.'}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Welsh', 'Affiliation': 'Department of Radiation Oncology, The University of Texas M D Anderson Cancer Center, Houston, TX, USA. Electronic address: jwelsh@mdanderson.org.'}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(20)30391-X']
2241,33096028,Diagnostic value of parameters from a spot urine sample for renal potassium loss in hypokalemia.,"BACKGROUND


We assessed the value of 1) a spot urine test for diagnosing hypokalemia caused by renal potassium loss, and 2) actual 24-hour urine potassium excretion (24 hUK-actual) for diagnosing hypokalemia caused by renal potassium loss in patients treated with potassium supplementation. The study population was from Southwest China.
METHODS


Patients with hypokalemia were divided into 2 groups: hypokalemia caused by renal potassium loss (n=67) and hypokalemia caused by extrarenal potassium loss (n=63). Urine potassium concentration (UK), urine creatinine concentration (UCr), urine potassium-creatinine ratio (UK/UCr), fractional excretion of potassium (FEK), transtubular potassium concentration gradient (TTKG), and 24-h urine potassium excretion (24 hUK-calculated) were derived from spot urine samples collected on admission, before initiation of therapy. Patients received intravenous potassium chloride 0.4 or 0.6 g/h. 24 hUK-actual was detected in patients whose serum potassium did not return to normal after 24 h of therapy.
RESULTS


Patients with hypokalemia caused by renal potassium loss had significantly higher UK, UK/UCr, FEK, TTKG and 24 hUK-calculated compared to patients with hypokalemia caused by extrarenal potassium loss (P<0.05). FEK predicted renal potassium loss in hypokalemia with high accuracy at a cut-off of 9.29% (sensitivity, 80.6%; specificity, 85.7%). The area under the curve for 24 hUK-actual in predicting renal potassium loss in patients with hypokalemia treated with low or high-dose potassium chloride infusion were 0.939 or 0.956, respectively. On the spot urine test, FEK showed the highest correlation with 24 hUK-actual during low or high dose potassium chloride infusion (r=0.831, p<0.001 or r=0.764, p<0.001).
CONCLUSIONS


FEK from a spot urine sample represents a convenient and reliable parameter to predict renal potassium loss in patients with hypokalemia.",2020,"On the spot urine test, FEK showed the highest correlation with 24 hUK-actual during low or high dose potassium chloride infusion (r=0.831, p<0.001 or r=0.764, p<0.001).
","['Patients with hypokalemia were divided into 2 groups: hypokalemia caused by renal potassium loss (n=67) and hypokalemia caused by extrarenal potassium loss (n=63', 'hypokalemia', 'The study population was from Southwest China', 'patients with hypokalemia', 'patients with hypokalemia treated with low or high-dose']","['potassium chloride infusion', 'intravenous potassium chloride', 'potassium supplementation']","['renal potassium loss', 'Urine potassium concentration (UK), urine creatinine concentration (UCr), urine potassium-creatinine ratio (UK/UCr), fractional excretion of potassium (FEK), transtubular potassium concentration gradient (TTKG), and 24-h urine potassium excretion (24 hUK-calculated']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020621', 'cui_str': 'Hypokalemia'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0444956', 'cui_str': 'High dose'}]","[{'cui': 'C0032825', 'cui_str': 'Potassium Chloride'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0360652', 'cui_str': 'Potassium-containing product in parenteral dose form'}, {'cui': 'C0008203', 'cui_str': 'Chloride salt'}, {'cui': 'C0561938', 'cui_str': 'Potassium supplementation'}]","[{'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C0202195', 'cui_str': 'Potassium measurement, urine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1318439', 'cui_str': 'Creatinine measurement, urine'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}]",,0.0248461,"On the spot urine test, FEK showed the highest correlation with 24 hUK-actual during low or high dose potassium chloride infusion (r=0.831, p<0.001 or r=0.764, p<0.001).
","[{'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Endocriology, The Affiliated Hospital of Southwest Medical University, Luzhou, 646000 Sichuan China. Electronic address: lijia0876@126.com.'}, {'ForeName': 'Hongyan', 'Initials': 'H', 'LastName': 'Ma', 'Affiliation': 'Department of Endocriology, The Affiliated Hospital of Southwest Medical University, Luzhou, 646000 Sichuan China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Lei', 'Affiliation': 'Department of Endocriology, The Affiliated Hospital of Southwest Medical University, Luzhou, 646000 Sichuan China.'}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Wan', 'Affiliation': 'Department of Endocriology, The Affiliated Hospital of Southwest Medical University, Luzhou, 646000 Sichuan China.'}]",Clinica chimica acta; international journal of clinical chemistry,['10.1016/j.cca.2020.10.024']
2242,33096120,"The impact of red grape juice (Vitis labrusca)consumption associated with physical training on oxidative stress, inflammatory and epigenetic modulation in healthy elderly women.","The imbalance of epigenetic, oxidative stress and inflammatory markers is associated with the aging physiopathology. Then, the influence of bioactive nutritional compounds and physical training on these biomarkers has been studied, although the combination of both strategies has been not investigated. Therefore, our aim was to verify the effect of the association of physical training with red grape juice (Vitis labrusca) consumption on global histone acetylation H3 and H4 levels, oxidative stress markers and interleukin 6 (IL-6) levels in peripheral blood of healthy elderly women. This double-blind randomized clinical study consisted of 29 volunteers, aged 59 years and over, divided into three groups: grape juice group (GJG, n = 9); placebo and exercise group (PLEG, n = 10) and grape juice and exercise group (GJEG, n = 10). During 1 month, GJG consumed 400 ml of grape juice per day (integral and conventional), while the PLEG and GJEG groups, besides consuming juice or placebo were submitted to a concurrent physical training protocol (two times per week, 60 minutes / session). The volunteers were submitted to blood collections before and after the intervention for the biomarkers analysis, e.g. IL-6, histone acetylation H3 and H4, lipid oxidative damage (TBARS), proteins (Carbonyl), non-enzymatic antioxidant defense (Sulfhydryl groups) and activity of antioxidant enzymes (superoxide dismutase and catalase). There were no statistically significant differences in the global levels of histone acetylation H3 and H4 post intervention compared to the basal period as well and between groups were found. However, PLEG and GJEG showed a remarkable reduction on IL-6 levels after intervention. We also observed an increase in Carbonyl levels, SOD activities and Sulfhydryl levels comparing before and after intervention. Considering the interaction of time and groups, a significant increase in Sulfhydryl levels only in GJG was found. The physical training protocol associated or not with grape juice consumption showed anti-inflammatory effects and an influence in the antioxidant defenses (non enzymatic and enzymatic) in elderly women. However in grape juice group, without exercise, we observed an increase in non enzymatic antioxidant defense, what could be attributed to the polyphenols content. These responses seem not to be involved with histone acetylation status.",2020,The physical training protocol associated or not with grape juice consumption showed anti-inflammatory effects and an influence in the antioxidant defenses (non enzymatic and enzymatic) in elderly women.,"['29 volunteers, aged 59 years', 'peripheral blood of healthy elderly women', 'elderly women', 'healthy elderly women']","['PLEG and GJEG', 'grape juice group (GJG, n\u202f=\u202f9); placebo and exercise group (PLEG, n\u202f=\u202f10) and grape juice and exercise group (GJEG, n\u202f=\u202f10', 'placebo', 'bioactive nutritional compounds and physical training', 'red grape juice (Vitis labrusca)consumption associated with physical training', 'physical training with red grape juice (Vitis labrusca) consumption']","['Sulfhydryl levels', 'global histone acetylation H3 and H4 levels, oxidative stress markers and interleukin 6 (IL-6) levels', 'Carbonyl levels, SOD activities and Sulfhydryl levels', 'oxidative stress, inflammatory and epigenetic modulation', 'non enzymatic antioxidant defense', 'global levels of histone acetylation H3', 'IL-6, histone acetylation H3 and H4, lipid oxidative damage (TBARS), proteins (Carbonyl), non-enzymatic antioxidant defense (Sulfhydryl groups) and activity of antioxidant enzymes (superoxide dismutase and catalase', 'IL-6 levels']","[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0524338', 'cui_str': 'Elderly woman'}]","[{'cui': 'C0452455', 'cui_str': 'Grape juice'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0205198', 'cui_str': 'Compound'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332575', 'cui_str': 'Red color'}, {'cui': 'C0949819', 'cui_str': 'Vitis'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0038734', 'cui_str': 'Sulfhydryls'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0019652', 'cui_str': 'Histone'}, {'cui': 'C0001038', 'cui_str': 'Acetylation'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1655731', 'cui_str': 'Epigenetic'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0014442', 'cui_str': 'Enzyme'}, {'cui': 'C0007367', 'cui_str': 'CATALASE'}]",29.0,0.0363038,The physical training protocol associated or not with grape juice consumption showed anti-inflammatory effects and an influence in the antioxidant defenses (non enzymatic and enzymatic) in elderly women.,"[{'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Dani', 'Affiliation': 'Programa de Pós Graduação em Biociências e Reabilitação do Centro Universitário Metodista-IPA, Porto Alegre, RS, Brasil. Electronic address: carolinedani@yahoo.com.br.'}, {'ForeName': 'Karen Moura', 'Initials': 'KM', 'LastName': 'Dias', 'Affiliation': 'Programa de Pós Graduação em Biociências e Reabilitação do Centro Universitário Metodista-IPA, Porto Alegre, RS, Brasil.'}, {'ForeName': 'Lucieli', 'Initials': 'L', 'LastName': 'Trevizol', 'Affiliation': 'Curso de Fisioterapia do Centro Universitário Metodista-IPA, Porto Alegre, RS, Brasil.'}, {'ForeName': 'Luisa', 'Initials': 'L', 'LastName': 'Bassôa', 'Affiliation': 'Curso de Fisioterapia do Centro Universitário Metodista-IPA, Porto Alegre, RS, Brasil.'}, {'ForeName': 'Iasmin', 'Initials': 'I', 'LastName': 'Fraga', 'Affiliation': 'Programa de Pós Graduação em Ciências Biológicas: Fisiologia, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brasil.'}, {'ForeName': 'Isabel Cristina Teixeira', 'Initials': 'ICT', 'LastName': 'Proença', 'Affiliation': 'Programa de Pós Graduação em Biociências e Reabilitação do Centro Universitário Metodista-IPA, Porto Alegre, RS, Brasil.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Pochmann', 'Affiliation': 'Programa de Pós Graduação em Biociências e Reabilitação do Centro Universitário Metodista-IPA, Porto Alegre, RS, Brasil.'}, {'ForeName': 'Viviane Rostirola', 'Initials': 'VR', 'LastName': 'Elsner', 'Affiliation': 'Programa de Pós Graduação em Biociências e Reabilitação do Centro Universitário Metodista-IPA, Porto Alegre, RS, Brasil; Curso de Fisioterapia do Centro Universitário Metodista-IPA, Porto Alegre, RS, Brasil; Programa de Pós Graduação em Ciências Biológicas: Fisiologia, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brasil.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113215']
2243,33096497,"Feasibility of a Nurse-Trained, Family Member-Delivered Rehabilitation Model for Disabled Stroke Patients in Rural Chongqing, China.","BACKGROUND AND OBJECTIVE


Stroke rehabilitation was seriously inadequate in rural regions of China. This study aimed to evaluate the feasibility of a novel nurse-trained, family member-delivered rehabilitation model for disabled stroke patients in rural southwest China.
METHODS


A single-center randomized controlled trial was conducted at a rural county hospital in Chongqing, China. Eligible stroke patients were randomly assigned to an intervention group or to a control group. In the intervention group, patients and their caregivers received stroke rehabilitation training focusing on mobility, self-care, and toileting delivered by trained nurses before discharge, and 3 post-discharge telephone calls at 2nd, 4th, and 8th week. The control group received routine care. The primary outcome was functional independence indicating by Barthel Index (BI) scores, and secondary outcomes included health-related quality of life (EuroQol five dimensions questionnaire, EQ-5D) and caregiver burden (Caregiver Burden Inventory, CBI). Outcome assessment was carried out at pre-discharge, 3- and 6-months after discharge.
RESULTS


A total of 61 stroke patients were recruited and randomly assigned to the intervention group (n=31) or the control group (n = 30). Compared with that in the control group, BI increased more at 3 months and decreased less at 6 months in the intervention group, there was a significant difference in mean BI scores across the three time points (F = 21.96, p = 0.0001), but no significant between-group difference (F = 0.94, p = 0.3371). In the intervention group, BI scores at 3-and 6-months post-discharge were higher than that before discharge (t = 8.38, p = 0.0001; t = 4.14, p = 0.0003). In the control group, BI scores at 3 months were higher than that before discharge (t = 5.29, p = 0.0001), but no significant difference at 6 months. At 6 months post-discharge, the intervention group and the control group had similar EQ-5D scores (p = 0.91), and similar CBI scores (3.67 vs 3.68, p = 0.98).
CONCLUSIONS


The study showed that the novel nurse-trained, family member-delivered rehabilitation model improved physical recovery indicated by BI scores without increasing caregiver burden, compared to usual care, for rural stroke patients in southwest China.",2020,"In the intervention group, BI scores at 3-and 6-months post-discharge were higher than that before discharge (t = 8.38, p = ","['rural stroke patients in southwest China', 'Disabled Stroke Patients in Rural Chongqing, China', 'Eligible stroke patients', '61 stroke patients', 'rural county hospital in Chongqing, China', 'rural regions of China', 'disabled stroke patients in rural southwest China']","['stroke rehabilitation training focusing on mobility, self-care, and toileting delivered by trained nurses before discharge, and 3 post-discharge telephone calls', 'Nurse-Trained, Family Member-Delivered Rehabilitation Model', 'novel nurse-trained, family member-delivered rehabilitation model', 'routine care']","['BI scores', 'functional independence indicating by Barthel Index (BI) scores, and secondary outcomes included health-related quality of life (EuroQol five dimensions questionnaire, EQ-5D) and caregiver burden (Caregiver Burden Inventory, CBI', 'EQ-5D scores', 'similar CBI scores', 'mean BI scores']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0018576', 'cui_str': 'Handicapped'}, {'cui': 'C0020005', 'cui_str': 'County Hospitals'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C0204097', 'cui_str': 'Stroke rehabilitation'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C2733251', 'cui_str': 'EuroQoL five dimension questionnaire'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0259095', 'cui_str': '9a-chloromethyl-1,2,9,9a-tetrahydrocyclopropa(c)benz(e)indol-4-one'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",61.0,0.102098,"In the intervention group, BI scores at 3-and 6-months post-discharge were higher than that before discharge (t = 8.38, p = ","[{'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Chu', 'Affiliation': 'School of Public Health and Management, Medical and Social Development Research Center, Chongqing Medical University, Chongqing 400016, China. Electronic address: chukun@stu.cqmu.edu.cn.'}, {'ForeName': 'Xiaoqing', 'Initials': 'X', 'LastName': 'Bu', 'Affiliation': 'School of Public Health and Management, Medical and Social Development Research Center, Chongqing Medical University, Chongqing 400016, China.'}, {'ForeName': 'Zhenxing', 'Initials': 'Z', 'LastName': 'Sun', 'Affiliation': 'Yuzhong Center for Disease Control and Prevention, Chongqing 400010, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Dianjiang People's Hospital of Chongqing, Chongqing 408300, China.""}, {'ForeName': 'Wenqin', 'Initials': 'W', 'LastName': 'Feng', 'Affiliation': ""Dianjiang People's Hospital of Chongqing, Chongqing 408300, China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Xiao', 'Affiliation': ""Dianjiang People's Hospital of Chongqing, Chongqing 408300, China.""}, {'ForeName': 'Fuyan', 'Initials': 'F', 'LastName': 'Jiang', 'Affiliation': ""Dianjiang People's Hospital of Chongqing, Chongqing 408300, China.""}, {'ForeName': 'Xiaojun', 'Initials': 'X', 'LastName': 'Tang', 'Affiliation': 'School of Public Health and Management, Medical and Social Development Research Center, Chongqing Medical University, Chongqing 400016, China. Electronic address: tangxiaoj0726@qq.com.'}]",Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association,['10.1016/j.jstrokecerebrovasdis.2020.105382']
2244,33096517,Bilateral ultrasound-guided erector spinae plane block in patients undergoing lumbar spinal fusion: A randomized controlled trial.,"STUDY OBJECTIVE


Spinal fusion surgery is associated with severe postoperative pain. We examined whether bilateral ultrasound-guided erector spinae plane block could alleviate postoperative pain in patients undergoing lumbar spinal fusion.
DESIGN


Blinded, randomized, controlled study.
SETTING


Tertiary university hospital, operating room, postoperative recovery room and ward.
PATIENTS


Sixty patients with American Society of Anesthesiologists grade I or II scheduled for lumbar spinal fusion surgery were randomized into the erector spinae plane block group (ESPB group) and the control group in a 1:1 ratio.
INTERVENTIONS


Pre-operative ultrasound-guided bilateral erector spinae plane block was performed in the ESPB group, while sham subcutaneous infiltration was performed in the control group.
MEASUREMENTS


The primary outcome was pain intensity at rest within 12 h postoperatively using the Numeric Rating Scale (NRS). Secondary outcomes included NRS pain scores at rest and on movement, postoperative opioid consumption and proportions of patients requiring opioid during the first 48 h after surgery.
MAIN RESULTS


The ESPB group (n = 30) showed significantly lower pain scores at rest at 4 h after surgery (estimated mean difference - 1.6, 95% confidence interval [CI] -2.4 to -0.8, p < 0.001), at 8 h (-1.3, 95% CI -1.9 to -0.6, p < 0.001), and at 12 h (-0.7, 95% CI -1.3 to -0.1, p = 0.023). The two groups showed similar pain scores at rest at 24 h after surgery (estimated mean difference - 0.2, 95% CI -0.8 to 0.5) and 48 h (-0.3, 95% CI -0.8 to 0.2). The ESPB group also showed significantly lower pain score on movement at 4 h after surgery (-1.5, 95% CI -2.5 to -0.6). The ESPB group showed a significantly smaller proportion of patients requiring sufentanil within 12 h after surgery (p = 0.020), and the group consumed significantly less sufentanil during that period (p = 0.042).
CONCLUSIONS


Bilateral ultrasound-guided erector spinae plane block improves postoperative analgesia in patients undergoing lumbar spinal fusion.",2020,"MAIN RESULTS


The ESPB group (n = 30) showed significantly lower pain scores at rest at 4 h after surgery (estimated mean difference - 1.6, 95% confidence interval [CI] -2.4 to -0.8, p < 0.001), at 8 h (-1.3, 95% CI -1.9 to -0.6, p < 0.001), and at 12 h (-0.7, 95% CI -1.3 to -0.1, p = 0.023).","['Sixty patients with American Society of Anesthesiologists grade I or II scheduled for lumbar spinal fusion surgery', 'patients undergoing lumbar spinal fusion', 'Tertiary university hospital, operating room, postoperative recovery room and ward']","['sufentanil', 'bilateral ultrasound-guided erector spinae plane block', 'Pre-operative ultrasound-guided bilateral erector spinae plane block', 'erector spinae plane block group (ESPB group) and the control group in a 1:1 ratio', 'ESPB', 'Bilateral ultrasound-guided erector spinae plane block']","['postoperative analgesia', 'pain intensity at rest within 12\xa0h postoperatively using the Numeric Rating Scale (NRS', 'smaller proportion of patients requiring sufentanil', 'pain score', 'pain scores', 'similar pain scores', 'NRS pain scores at rest and on movement, postoperative opioid consumption and proportions of patients requiring opioid during the first 48\xa0h after surgery']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0186045', 'cui_str': 'Lumbar spinal fusion'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0034871', 'cui_str': 'Postoperative anesthesia care unit'}, {'cui': 'C1305702', 'cui_str': 'Ward'}]","[{'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0224301', 'cui_str': 'Structure of erector spinae muscle'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]","[{'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",60.0,0.356452,"MAIN RESULTS


The ESPB group (n = 30) showed significantly lower pain scores at rest at 4 h after surgery (estimated mean difference - 1.6, 95% confidence interval [CI] -2.4 to -0.8, p < 0.001), at 8 h (-1.3, 95% CI -1.9 to -0.6, p < 0.001), and at 12 h (-0.7, 95% CI -1.3 to -0.1, p = 0.023).","[{'ForeName': 'Qingfen', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': ""Department of Anesthesiology, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Yaqing', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': ""Department of Anesthesiology, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Ren', 'Affiliation': ""Department of Anesthesiology, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Xizhe', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ""Department of Anesthesiology, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Feng', 'Affiliation': ""Department of Anesthesiology, Peking University People's Hospital, Beijing, China. Electronic address: yifeng_65@163.com.""}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.110090']
2245,33096545,Does acute soccer heading cause an increase in plasma S100B? A randomized controlled trial.,"The purpose of this study was to test the effect of subconcussive head impacts on acute changes in plasma S100B. In this randomized controlled trial, 79 healthy adult soccer players were randomly assigned to either the heading (n = 41) or kicking-control groups (n = 38). The heading group executed 10 headers with soccer balls projected at a speed of 25 mph, whereas the kicking-control group performed 10 kicks. Plasma samples were obtained at pre-, 0h post-, 2h post- and 24h post-intervention and measured for S100B. The primary hypothesis was that there would be a significant group difference (group-by-time interaction) in plasma S100B at 2h post-intervention. Secondary hypotheses included (1) no significant group differences in plasma S100B concentrations at 0h post- and 24h post-intervention; (2) a significant within-group increase in S100B concentrations in the heading group at 2h post-intervention compared to pre-intervention; and (3) no significant within-group changes in plasma S100B in the kicking-control group. Data from 68 subjects were available for analysis (heading n = 37, kicking n = 31). There were no differences in S100B concentrations between heading and kicking groups over time, as evidenced by nonsignificant group-by-time interaction at 2h post-intervention (B = 2.20, 95%CI [-22.22, 26.63], p = 0.86) and at all the other time points (0h post: B = -11.05, 95%CI [-35.37, 13.28], p = 0.38; 24h post: B = 16.11, 95%CI [-8.29, 40.51], p = 0.20). Part of the secondary outcome, the heading group showed elevation in plasma S100B concentrations at 24h post-intervention compared to pre-heading baseline (B = 19.57, 95%CI [3.13, 36.02], p = 0.02), whereas all other within-group comparisons in both remained nonsignificant. The data suggest that 10 bouts of acute controlled soccer headings do not elevate S100B concentrations up to 24-hour post-heading. Further dose-response studies with longer follow-up time points may help determine thresholds of acute soccer heading exposure that are related to astrocyte activation. The protocol was registered under ClinicalTrials.gov (NCT03488381; retrospectively registered.).",2020,"There were no differences in S100B concentrations between heading and kicking groups over time, as evidenced by nonsignificant group-by-time interaction at 2h post-intervention (B = 2.20, 95%CI [-22.22, 26.63], p = 0.86) and at all the other time points (0h post: B = -11.05, 95%CI [-35.37, 13.28], p = 0.38; 24h post: B = 16.11, 95%CI [-8.29, 40.51], p = 0.20).","['79 healthy adult soccer players', '68 subjects were available for analysis (heading n = 37, kicking n = 31']",[],"['plasma S100B', 'acute changes in plasma S100B', 'elevation in plasma S100B concentrations', 'plasma S100B concentrations', 'S100B concentrations']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}]",[],"[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",79.0,0.196685,"There were no differences in S100B concentrations between heading and kicking groups over time, as evidenced by nonsignificant group-by-time interaction at 2h post-intervention (B = 2.20, 95%CI [-22.22, 26.63], p = 0.86) and at all the other time points (0h post: B = -11.05, 95%CI [-35.37, 13.28], p = 0.38; 24h post: B = 16.11, 95%CI [-8.29, 40.51], p = 0.20).","[{'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Huibregtse', 'Affiliation': 'Department of Kinesiology, Indiana University School of Public Health-Bloomington, Bloomington, Bloomington, Indiana, United States of America.'}, {'ForeName': 'Madeleine K', 'Initials': 'MK', 'LastName': 'Nowak', 'Affiliation': 'Department of Kinesiology, Indiana University School of Public Health-Bloomington, Bloomington, Bloomington, Indiana, United States of America.'}, {'ForeName': 'Joseph E', 'Initials': 'JE', 'LastName': 'Kim', 'Affiliation': 'Department of Kinesiology, Indiana University School of Public Health-Bloomington, Bloomington, Bloomington, Indiana, United States of America.'}, {'ForeName': 'Rachel M', 'Initials': 'RM', 'LastName': 'Kalbfell', 'Affiliation': 'Department of Kinesiology, Indiana University School of Public Health-Bloomington, Bloomington, Bloomington, Indiana, United States of America.'}, {'ForeName': 'Alekhya', 'Initials': 'A', 'LastName': 'Koppineni', 'Affiliation': 'Department of Kinesiology, Indiana University School of Public Health-Bloomington, Bloomington, Bloomington, Indiana, United States of America.'}, {'ForeName': 'Keisuke', 'Initials': 'K', 'LastName': 'Ejima', 'Affiliation': 'Department of Epidemiology and Biostatistics, Indiana University School of Public Health-Bloomington, Bloomington, Indiana, United States of America.'}, {'ForeName': 'Keisuke', 'Initials': 'K', 'LastName': 'Kawata', 'Affiliation': 'Department of Kinesiology, Indiana University School of Public Health-Bloomington, Bloomington, Bloomington, Indiana, United States of America.'}]",PloS one,['10.1371/journal.pone.0239507']
2246,33096550,"Adults Who Are Overweight or Obese and Consuming an Energy-Restricted Healthy US-Style Eating Pattern at Either the Recommended or a Higher Protein Quantity Perceive a Shift from ""Poor"" to ""Good"" Sleep: A Randomized Controlled Trial.","BACKGROUND


Limited evidence suggests that consuming a higher-protein diet during weight loss improves subjective indices of sleep in overweight and obese adults.
OBJECTIVE


We sought to a priori assess the effects of consuming the recommended versus a higher protein Healthy US-Style Eating Pattern during energy-restriction on sleep quality indices.
DESIGN


Using a randomized, parallel study design, 51 adults (mean ± SEM age: 47 ± 1 y; BMI: 32.6 ± 0.5 kg/m2) consumed a controlled USDA Healthy US-Style Eating Pattern containing 750 kcal/d less than their estimated energy requirement for 12 wk. Participants were randomly assigned to consume either 5 or 12.5 oz-equivalent (eq)/d of protein foods. The additional 7.5 oz-eq/d came from animal-based protein sources and displaced primarily grains. Objective (wrist-worn actigraphy) and subjective (Pittsburgh Sleep Quality Index, Epworth Sleepiness Scale) sleep quality indices were measured at baseline, week 6, and week 12.
RESULTS


Among all participants, body mass decreased (-6.2 ± 0.4 kg). Dietary protein intake did not affect any objective or subjective sleep quality outcomes measured (repeated measures ANOVA). Over time, objective measures of time spent in bed, time spent sleeping, sleep onset latency, and time awake after sleep onset did not change; however, sleep efficiency improved (1 ± 1%; P = 0.027). Subjectively, global sleep scores [GSS: -2.7 ± 0.4 arbitrary units (au)] and daytime sleepiness scores (-3.8 ± 0.4 au; both P < 0.001) improved over time. The GSS improvement transitioned the participants from being categorized with ""poor"" to ""good"" sleep (GSS: >5 compared with ≤5 au of a 0-21 au scale; baseline 7.6 ± 0.4 au, week 12: 4.8 ± 0.4 au).
CONCLUSIONS


Although objective sleep quality may not improve, adults who are overweight or obese and poor sleepers may become good sleepers while consuming either the recommended or a higher-protein energy-restricted Healthy US-Style Eating Pattern. This trial was registered at clinicaltrials.gov as NCT03174769.",2020,"Subjectively, global sleep scores [GSS: -2.7 ± 0.4 arbitrary units (au)] and daytime sleepiness scores (-3.8 ± 0.4 au; both P < 0.001) improved over time.","['Adults Who Are Overweight or Obese and Consuming an Energy-Restricted Healthy US-Style Eating Pattern at Either the Recommended or a Higher Protein Quantity Perceive a Shift from ""Poor"" to ""Good"" Sleep', '51 adults (mean\xa0±\xa0SEM age: 47\xa0±\xa01 y; BMI: 32.6\xa0±\xa00.5\xa0kg/m2) consumed a', 'overweight and obese adults', 'adults who are overweight or obese and poor sleepers']","['controlled USDA Healthy US-Style Eating Pattern containing 750\xa0kcal/d less than their estimated energy requirement for 12 wk', 'higher protein Healthy US-Style Eating Pattern during energy-restriction', 'consume either 5 or 12.5 oz-equivalent (eq)/d of protein foods']","['Objective (wrist-worn actigraphy) and subjective', 'sleep efficiency', 'Pittsburgh Sleep Quality Index, Epworth Sleepiness Scale) sleep quality indices', 'Subjectively, global sleep scores [GSS: -2.7\xa0±\xa00.4 arbitrary units (au)] and daytime sleepiness scores', 'time spent in bed, time spent sleeping, sleep onset latency, and time awake after sleep onset', 'objective or subjective sleep quality outcomes', 'body mass']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0262878', 'cui_str': 'Scanning electron microscope'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0085410', 'cui_str': 'Department of Agriculture (U.S.)'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C4517868', 'cui_str': '750'}, {'cui': 'C0456649', 'cui_str': 'kcal/day'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0489460', 'cui_str': 'Energy requirement'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0347984', 'cui_str': 'During'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C4517544', 'cui_str': '12.5'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0453858', 'cui_str': 'Protein food'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C3541276', 'cui_str': 'Epworth Sleepiness Scale'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0017495', 'cui_str': 'Gerstmann-Straussler-Scheinker syndrome'}, {'cui': 'C4517635', 'cui_str': '2.7'}, {'cui': 'C4517457', 'cui_str': '0.4'}, {'cui': 'C0439183', 'cui_str': 'Arbitrary unit'}, {'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0234422', 'cui_str': 'Awake'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}]",51.0,0.0575621,"Subjectively, global sleep scores [GSS: -2.7 ± 0.4 arbitrary units (au)] and daytime sleepiness scores (-3.8 ± 0.4 au; both P < 0.001) improved over time.","[{'ForeName': 'Joshua L', 'Initials': 'JL', 'LastName': 'Hudson', 'Affiliation': 'Department of Nutrition Science, Purdue University, West Lafayette, IN, USA.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Department of Nutrition Science, Purdue University, West Lafayette, IN, USA.'}, {'ForeName': 'Wayne W', 'Initials': 'WW', 'LastName': 'Campbell', 'Affiliation': 'Department of Nutrition Science, Purdue University, West Lafayette, IN, USA.'}]",The Journal of nutrition,['10.1093/jn/nxaa302']
2247,33096554,A Whole-Diet Approach Affects Not Only Fasting but Also Postprandial Cardiometabolic Risk Markers in Overweight and Obese Adults: A Randomized Controlled Trial.,"BACKGROUND


Current dietary recommendations for cardiovascular disease (CVD) prevention focus more on dietary patterns than on single nutrients. However, randomized controlled trials using whole-diet approaches to study effects on both fasting and postprandial CVD risk markers are limited.
OBJECTIVE


This randomized parallel trial compared the effects of a healthy diet (HD) with those of a typical Western diet (WD) on fasting and postprandial CVD risk markers in overweight and obese adults.
METHODS


After a 2-wk run-in period, 40 men and women (50-70 y; BMI: 25-35 kg/m2) consumed the HD (high in fruit and vegetables, pulses, fibers, nuts, fatty fish, polyunsaturated fatty acids; low in salt and high-glycemic carbohydrates; n = 19) or the WD (less fruit, vegetables, and fibers; no nuts and fatty fish; and more saturated fatty acids and simple carbohydrates; n = 21) for 6 wk. Fasting and postprandial cardiometabolic risk markers were assessed as secondary outcome parameters during a 5-h mixed-meal challenge, and a per protocol analysis was performed using 1-factor ANCOVA or linear mixed models.
RESULTS


Differences in diet-induced changes are expressed relative to the HD group. Changes in fasting plasma total cholesterol (-0.57 ± 0.12 mmol/L, P < 0.001), LDL cholesterol (-0.41 ± 0.12 mmol/L, P < 0.01), apolipoprotein B100 (-0.09 ± 0.03 g/L, P < 0.01), and apolipoprotein A1 (-0.06 ± 0.03 g/L, P = 0.05) were significantly different between the diet groups. Changes in postprandial plasma triacylglycerol (diet × time, P < 0.001) and apolipoprotein B48 (P < 0.01) differed significantly between the groups with clear improvements on the HD, although fasting triacylglycerols (-0.24 ± 0.13 mmol/L, P = 0.06) and apolipoprotein B48 (1.04 ± 0.67 mg/L, P = 0.40) did not. Significant differences between the diets were also detected in fasting systolic (-6.9 ± 3.1 mmHg, P < 0.05) and 24-h systolic (-5.0 ± 1.7 mmHg, P < 0.01) and diastolic (-3.3 ± 1.1 mmHg, P < 0.01) blood pressure.
CONCLUSION


A whole-diet approach targeted multiple fasting and postprandial CVD risk markers in overweight and obese adults. In fact, the postprandial measurements provided important additional information to estimate CVD risk. This trial is registered at clinicaltrials.gov as NCT02519127.",2020,"Changes in fasting plasma total cholesterol (-0.57 ± 0.12 mmol/L, P ","['40 men and women (50-70 y; BMI: 25-35 kg/m2', 'Overweight and Obese Adults', 'overweight and obese adults']","['consumed the HD (high in fruit and vegetables, pulses, fibers, nuts, fatty fish, polyunsaturated fatty acids; low in salt and high-glycemic carbohydrates; n\xa0=\xa019) or the WD (less fruit, vegetables, and fibers; no nuts and fatty fish; and more saturated fatty acids and simple carbohydrates', 'healthy diet (HD) with those of a typical Western diet (WD']","['fasting plasma total cholesterol', 'fasting and postprandial CVD risk markers', 'LDL cholesterol', 'blood pressure', '24-h systolic', 'apolipoprotein A1', 'apolipoprotein B48', 'apolipoprotein B100 (-0.09\xa0±', 'fasting triacylglycerols', 'fasting systolic', 'postprandial plasma triacylglycerol (diet × time, P', 'multiple fasting and postprandial CVD risk markers', 'Fasting and postprandial cardiometabolic risk markers', 'Postprandial Cardiometabolic Risk Markers']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0028723', 'cui_str': 'Nut'}, {'cui': 'C0453017', 'cui_str': 'Fatty fish'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C3849996', 'cui_str': 'Western Diet'}, {'cui': 'C0205352', 'cui_str': 'Simple'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0085201', 'cui_str': 'Apolipoprotein A-I'}, {'cui': 'C0103839', 'cui_str': 'Apolipoprotein B-48'}, {'cui': 'C0205666', 'cui_str': 'Apolipoprotein B-100'}, {'cui': 'C4517419', 'cui_str': '0.09'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}]",,0.0381722,"Changes in fasting plasma total cholesterol (-0.57 ± 0.12 mmol/L, P ","[{'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Fechner', 'Affiliation': 'Department of Nutrition and Movement Sciences, Maastricht University Medical Center+, Maastricht, The Netherlands.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Bilet', 'Affiliation': 'Department of Nutrition and Movement Sciences, Maastricht University Medical Center+, Maastricht, The Netherlands.'}, {'ForeName': 'Harry P F', 'Initials': 'HPF', 'LastName': 'Peters', 'Affiliation': 'Unilever Food Innovation Center, Wageningen, The Netherlands.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Schrauwen', 'Affiliation': 'Department of Nutrition and Movement Sciences, Maastricht University Medical Center+, Maastricht, The Netherlands.'}, {'ForeName': 'Ronald P', 'Initials': 'RP', 'LastName': 'Mensink', 'Affiliation': 'Department of Nutrition and Movement Sciences, Maastricht University Medical Center+, Maastricht, The Netherlands.'}]",The Journal of nutrition,['10.1093/jn/nxaa252']
2248,31791288,Efficacy and safety of sodium zirconium cyclosilicate in patients with baseline serum potassium level ≥ 5.5 mmol/L: pooled analysis from two phase 3 trials.,"BACKGROUND


Reliable, timely-onset, oral treatments with an acceptable safety profile for patients with hyperkalemia are needed. We examined the efficacy and safety of sodium zirconium cyclosilicate (SZC; formerly ZS-9) treatment for ≤ 48 h in patients with baseline serum potassium level ≥ 5.5 mmol/L.
METHODS


Data were pooled from two phase 3 studies (ZS-003 and HARMONIZE) among patients receiving SZC 10 g three times daily. Outcomes included mean and absolute change from baseline, median time to potassium level ≤ 5.5 and ≤ 5.0 mmol/L, and proportion achieving potassium level ≤ 5.5 and ≤ 5.0 mmol/L at 4, 24, and 48 h. Outcomes were stratified by baseline potassium. Safety outcomes were evaluated.
RESULTS


At baseline, 125 of 170 patients (73.5%) had potassium level 5.5-< 6.0, 39 (22.9%) had potassium level 6.0-6.5, and 6 (3.5%) had potassium level > 6.5 mmol/L. Regardless of baseline potassium, mean potassium decreased at 1 h post-initial dose. By 4 and 48 h, 37.5% and 85.0% of patients achieved potassium level ≤ 5.0 mmol/L, respectively. Median (95% confidence interval) times to potassium level ≤ 5.5 and ≤ 5.0 mmol/L were 2.0 (1.1-2.0) and 21.6 (4.1-22.4) h, respectively. Fifteen patients (8.8%) experienced adverse events; none were serious.
CONCLUSIONS


SZC 10 g three times daily achieved serum potassium reduction and normokalemia, with a favorable safety profile.
TRIAL REGISTRATION


ClinicalTrials.gov identifiers: ZS-003: NCT01737697 and HARMONIZE: NCT02088073.",2019,"Median (95% confidence interval) times to potassium level ≤ 5.5 and ≤ 5.0 mmol/L were 2.0 (1.1-2.0) and 21.6 (4.1-22.4) h, respectively.","['patients with baseline serum potassium level ≥ 5.5 mmol/L', 'patients with hyperkalemia', '≤\u200948\u2009h in patients with baseline serum potassium level\u2009≥\u20095.5\u2009mmol/L']","['SZC 10', 'sodium zirconium cyclosilicate', 'sodium zirconium cyclosilicate (SZC']","['mean and absolute change from baseline, median time to potassium level\u2009≤\u20095.5 and\u2009≤\u20095.0\u2009mmol/L, and proportion achieving potassium level', 'adverse events', 'potassium level', 'Efficacy and safety', 'serum potassium reduction and normokalemia', 'mean potassium']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0302353', 'cui_str': 'Serum potassium measurement'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C0020461', 'cui_str': 'Hyperkalemia'}]","[{'cui': 'C4045824', 'cui_str': 'sodium zirconium cyclosilicate'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0202194', 'cui_str': 'Potassium measurement'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0302353', 'cui_str': 'Serum potassium measurement'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}]",,0.166618,"Median (95% confidence interval) times to potassium level ≤ 5.5 and ≤ 5.0 mmol/L were 2.0 (1.1-2.0) and 21.6 (4.1-22.4) h, respectively.","[{'ForeName': 'Alpesh N', 'Initials': 'AN', 'LastName': 'Amin', 'Affiliation': 'Present Address: University of California Irvine Medical Center, 101 The City Drive South, Orange, CA, 92868, USA. anamin@uci.edu.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Menoyo', 'Affiliation': 'Affiliation at the time the study was conducted: ZS Pharma, Inc., a member of the AstraZeneca family of companies, San Mateo, CA, USA.'}, {'ForeName': 'Bhupinder', 'Initials': 'B', 'LastName': 'Singh', 'Affiliation': 'Present Address: University of California Irvine Medical Center, 101 The City Drive South, Orange, CA, 92868, USA.'}, {'ForeName': 'Christopher S', 'Initials': 'CS', 'LastName': 'Kim', 'Affiliation': 'Division of General Medicine, University of Washington, Seattle, WA, USA.'}]",BMC nephrology,['10.1186/s12882-019-1611-8']
2249,31832638,"Cotrimoxazole prophylaxis increases resistance gene prevalence and α-diversity but decreases β-diversity in the gut microbiome of HIV-exposed, uninfected infants.","BACKGROUND


Prophylactic cotrimoxazole treatment is recommended in HIV exposed, uninfected (HEU) infants, but the effects of this treatment on developing HEU infant gut microbiotas and resistomes are largely undefined.
METHODS


We analyzed whole-metagenome sequencing data from 163 longitudinally collected stool samples from 63 HEU infants randomized to receive (n=34) or to not receive (n=29) prophylactic cotrimoxazole treatment. We generated taxonomic, functional pathway, and resistance gene profiles for each sample and compared microbiome signatures between cotrimoxazole treated HEU infants (CTX-T infants) and HEU infants not treated with cotrimoxazole (CTX-N infants).
RESULTS


Metagenomic analysis did not reveal significant differences in taxonomic or functional pathway α-diversity between CTX-T infants and CTX-N infants. In contrast, resistance gene prevalence (p=0.00719) and α-diversity (p=0.0045) increased in CTX-T. These differences increased over time for both resistance gene prevalence measured by log normalized abundance (4 months mean 0.71, 95% CI [0.2, 1.2] and 6 months mean 0.85; 95% CI [0.1, 1.7]) and α-diversity (p=0.0045). Unlike α-diversity, interindividual gut microbiome taxonomic (mean -0.11; 95% CI [-0.15, -0.077]), functional taxonomic (mean -0.050; 95% CI [-0.084, -0.017]), and resistance gene (mean -0.13; 95% CI [-0.17, -0.099]) β-diversity decreased in CTX-T infants compared to CTX-N infants. These results are consistent with persistent antibiotic selection pressure.
CONCLUSIONS


Cotrimoxazole prophylaxis in HEU infants decreased gut microbiome β-diversity and increased antibiotic resistance gene α-diversity and prevalence. Antibiotic resistance is a growing threat, especially in low- and middle-income countries where the higher perinatal HIV-exposure rates result in cotrimoxazole prophylaxis. Understanding effects from current HEU infant antibiotic prophylaxis guidelines will inform guideline revisions and efforts to reduce increasing antibiotic resistance.",2019,"Unlike α-diversity, interindividual gut microbiome taxonomic (mean -0.11; 95% CI [-0.15, -0.077]), functional taxonomic (mean -0.050; 95% CI [-0.084, -0.017]), and resistance gene (mean -0.13; 95% CI [-0.17, -0.099]) β-diversity decreased in CTX-T infants compared to CTX-N infants.","['cotrimoxazole treated HEU infants (CTX-T infants) and HEU infants not treated with cotrimoxazole (CTX-N infants', '163 longitudinally collected stool samples from 63 HEU infants randomized to receive (n=34) or to not receive (n=29']","['Cotrimoxazole prophylaxis', 'prophylactic cotrimoxazole treatment']","['resistance gene prevalence', 'taxonomic or functional pathway α-diversity', 'resistance gene', 'functional taxonomic', 'Unlike α-diversity, interindividual gut microbiome taxonomic', 'β-diversity', 'gut microbiome β-diversity', 'antibiotic resistance', 'antibiotic resistance gene α-diversity and prevalence']","[{'cui': 'C0041044', 'cui_str': 'sulfamethoxazole and trimethoprim'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0010377', 'cui_str': 'Crotoxin'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1550661', 'cui_str': 'Stool specimen'}]","[{'cui': 'C0041044', 'cui_str': 'sulfamethoxazole and trimethoprim'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0008903', 'cui_str': 'classification'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0949285', 'cui_str': 'Antibiotic Resistance'}]",,0.133387,"Unlike α-diversity, interindividual gut microbiome taxonomic (mean -0.11; 95% CI [-0.15, -0.077]), functional taxonomic (mean -0.050; 95% CI [-0.084, -0.017]), and resistance gene (mean -0.13; 95% CI [-0.17, -0.099]) β-diversity decreased in CTX-T infants compared to CTX-N infants.","[{'ForeName': 'Alaric W', 'Initials': 'AW', 'LastName': ""D'Souza"", 'Affiliation': 'The Edison Family Center for Genome Sciences and Systems Biology, Washington University in St. Louis School of Medicine, Saint Louis, MO, USA.'}, {'ForeName': 'Eshia', 'Initials': 'E', 'LastName': 'Moodley-Govender', 'Affiliation': 'Department of Paediatrics and Child Health, University of KwaZulu-Natal, Durban, South Africa.'}, {'ForeName': 'Bertram', 'Initials': 'B', 'LastName': 'Berla', 'Affiliation': 'The Edison Family Center for Genome Sciences and Systems Biology, Washington University in St. Louis School of Medicine, Saint Louis, MO, USA.'}, {'ForeName': 'Tejas', 'Initials': 'T', 'LastName': 'Kelkar', 'Affiliation': 'The Edison Family Center for Genome Sciences and Systems Biology, Washington University in St. Louis School of Medicine, Saint Louis, MO, USA.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'The Edison Family Center for Genome Sciences and Systems Biology, Washington University in St. Louis School of Medicine, Saint Louis, MO, USA.'}, {'ForeName': 'Xiaoqing', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'The Edison Family Center for Genome Sciences and Systems Biology, Washington University in St. Louis School of Medicine, Saint Louis, MO, USA.'}, {'ForeName': 'Brodie', 'Initials': 'B', 'LastName': 'Daniels', 'Affiliation': 'Department of Paediatrics and Child Health, University of KwaZulu-Natal, Durban, South Africa.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Coutsoudis', 'Affiliation': 'Department of Paediatrics and Child Health, University of KwaZulu-Natal, Durban, South Africa.'}, {'ForeName': 'Indi', 'Initials': 'I', 'LastName': 'Trehan', 'Affiliation': 'Department of Pediatrics, Washington University in St Louis School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Gautam', 'Initials': 'G', 'LastName': 'Dantas', 'Affiliation': 'The Edison Family Center for Genome Sciences and Systems Biology, Washington University in St. Louis School of Medicine, Saint Louis, MO, USA.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz1186']
2250,33096810,A High Protein Calorie Restriction Diet Alters the Gut Microbiome in Obesity.,"BACKGROUND


High protein calorie restriction diets have shown clinical efficacy for obesity, but the mechanisms are not fully known. The intestinal microbiome is a mediator of obesity and preclinical data support an effect of high protein diet (HPD) on the gut microbiome of obesity, but there are few studies in humans.
METHODS


To address this, we conducted a dietary intervention trial of 80 overweight and obese subjects who were randomized to a calorie-restricted high protein diet (HPD) (30% calorie intake) or calorie-restricted normal protein diet (NPD) (15%) for 8 weeks. Baseline dietary intake patterns were assessed by the Diet History Questionnaire III. Longitudinal fecal sampling was performed at baseline, week 1, week 2, week 4, week 6, and week 8, for a total of 365 samples. Intestinal microbiome composition was assessed by 16S rRNA gene sequencing.
RESULTS


At baseline, microbial composition was associated with fiber and protein intake. Subjects on the HPD showed a significant increase in microbial diversity as measured by the Shannon index compared to those on the NPD. The HPD was also associated with significant differences in microbial composition after treatment compared to the NPD. Both diets induced taxonomic shifts compared to baseline, including enrichment of  Akkermansia spp.  and  Bifidobacterium spp.  and depletion of  Prevotella spp.  Conclusion: These findings provide evidence that weight loss diets alter the gut microbiome in obesity and suggest differential effects of HPDs compared to NPDs which may influence the clinical response to HPD.",2020,Subjects on the HPD showed a significant increase in microbial diversity as measured by the Shannon index compared to those on the NPD.,['80 overweight and obese subjects'],['calorie-restricted high protein diet (HPD) (30% calorie intake) or calorie-restricted normal protein diet (NPD'],"['Shannon index', 'microbial diversity', 'microbial composition', 'taxonomic shifts', 'Baseline dietary intake patterns', 'Intestinal microbiome composition']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0425403', 'cui_str': 'Increased protein diet'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0860902', 'cui_str': 'Protein NOS normal'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0008903', 'cui_str': 'classification'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}]",80.0,0.0173795,Subjects on the HPD showed a significant increase in microbial diversity as measured by the Shannon index compared to those on the NPD.,"[{'ForeName': 'Tien S', 'Initials': 'TS', 'LastName': 'Dong', 'Affiliation': 'The Vatche and Tamar Manoukian Division of Digestive Diseases, Department of Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA 90095, USA.'}, {'ForeName': 'Kayti', 'Initials': 'K', 'LastName': 'Luu', 'Affiliation': 'The Vatche and Tamar Manoukian Division of Digestive Diseases, Department of Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA 90095, USA.'}, {'ForeName': 'Venu', 'Initials': 'V', 'LastName': 'Lagishetty', 'Affiliation': 'The Vatche and Tamar Manoukian Division of Digestive Diseases, Department of Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA 90095, USA.'}, {'ForeName': 'Farzaneh', 'Initials': 'F', 'LastName': 'Sedighian', 'Affiliation': 'The Vatche and Tamar Manoukian Division of Digestive Diseases, Department of Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA 90095, USA.'}, {'ForeName': 'Shih-Lung', 'Initials': 'SL', 'LastName': 'Woo', 'Affiliation': 'Center for Human Nutrition, David Geffen School of Medicine at UCLA, Los Angeles, CA 90095, USA.'}, {'ForeName': 'Benjamin W', 'Initials': 'BW', 'LastName': 'Dreskin', 'Affiliation': 'Division of Gastroenterology, Hepatology and Parenteral Nutrition, Veterans Administration Greater Los Angeles Healthcare System, Los Angeles, CA 90073, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Katzka', 'Affiliation': 'The Vatche and Tamar Manoukian Division of Digestive Diseases, Department of Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA 90095, USA.'}, {'ForeName': 'Candace', 'Initials': 'C', 'LastName': 'Chang', 'Affiliation': 'The Vatche and Tamar Manoukian Division of Digestive Diseases, Department of Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA 90095, USA.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'The Vatche and Tamar Manoukian Division of Digestive Diseases, Department of Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA 90095, USA.'}, {'ForeName': 'Nerea', 'Initials': 'N', 'LastName': 'Arias-Jayo', 'Affiliation': 'The Vatche and Tamar Manoukian Division of Digestive Diseases, Department of Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA 90095, USA.'}, {'ForeName': 'Julianne', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'The Vatche and Tamar Manoukian Division of Digestive Diseases, Department of Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA 90095, USA.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Ahdoot', 'Affiliation': 'The Vatche and Tamar Manoukian Division of Digestive Diseases, Department of Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA 90095, USA.'}, {'ForeName': 'Zhaoping', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'UCLA Microbiome Center, David Geffen School of Medicine at UCLA, Los Angeles, CA 90095, USA.'}, {'ForeName': 'Joseph R', 'Initials': 'JR', 'LastName': 'Pisegna', 'Affiliation': 'The Vatche and Tamar Manoukian Division of Digestive Diseases, Department of Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA 90095, USA.'}, {'ForeName': 'Jonathan P', 'Initials': 'JP', 'LastName': 'Jacobs', 'Affiliation': 'The Vatche and Tamar Manoukian Division of Digestive Diseases, Department of Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA 90095, USA.'}]",Nutrients,['10.3390/nu12103221']
2251,33096946,Long-term outcomes of two ipsilateral versus single Double-J stent after laser endoureterotomy for Bilharzial ureteral strictures.,"BACKGROUND


Laser Endoureterotomy became a preferable choice for managing benign ureteral strictures. Ureteral stricture due to bilharzias is characterized by focal destruction of ureteral musculature, ending by fibrosis, making it poor responder to endouretrotomy. There is no consensus about the ideal ureteral stent size after endouretrotomy. However, many researches recommend larger stents caliber (12-14 Fr). We assess long-term efficacy of insertion of two ipsilateral Double-J stents versus single DJ stent after laser endouretrotomy for bilharzial ureteral stricture.
MATERIALS AND METHODS


Within 4 years, 70 patients underwent retrograde laser endouretrotomy for bilharzial ureteral stricture (diagnosed by positive history of bilhaziasis, positive serology test and/or bilhazial cystocopic finding). Patients with history of stone, urologic or pelvic surgery were excluded. Patients were randomized into two groups; the first group (31 patients) received ipsilateral two DJ (7-Fr each) post endouretrotomy, while the second group (32 patients) received one DJ (7-Fr). DJ,s were removed after 8 weeks. Follow-up was done regularly by clinical interpretation and imaging studies. Patients' characteristics, operative data, postoperative outcomes (subjectively and objectively) were compared in both groups.
RESULTS


Sixty three patients completed follow-up more than 18 months, mean follow-up 30 (±4) months [19-41], mean stricture length 1.4 (±0.6) cm [0.5-3.0], with no statistical significance between both groups. Success proved by relief of symptoms and radiographic resolution of obstruction. The overall success rate was significantly better in 2-DJ group than in 1-DJ group (83.9% Vs 53.1%) p =0.009, and also for stricture > 1.5 cm (85.7% Vs 38.5%) p=0.018 respectively.
CONCLUSIONS


Insertion of two ipsilateral DJ, after laser endoureterotomy for bilharzial ureteral stricture associated with long-term success rate better than insertion of 1-DJ, especially for stricture segment >1.5 cm.",2020,"The overall success rate was significantly better in 2-DJ group than in 1-DJ group (83.9% Vs 53.1%) p =0.009, and also for stricture > 1.5 cm (85.7% Vs 38.5%) p=0.018 respectively.
","['Bilharzial ureteral strictures', 'Patients with history of stone, urologic or pelvic surgery were excluded', '70 patients underwent', 'for bilharzial ureteral stricture (diagnosed by positive history of bilhaziasis, positive serology test and/or bilhazial cystocopic finding']","['1-DJ', 'two ipsilateral versus single Double-J stent', 'ipsilateral two DJ (7-Fr each) post endouretrotomy, while the second group (32 patients) received one DJ (7-Fr', 'retrograde laser endouretrotomy', 'two ipsilateral Double-J stents versus single DJ stent', '2-DJ']","['mean stricture length 1.4', 'relief of symptoms and radiographic resolution of obstruction', 'overall success rate']","[{'cui': 'C3887590', 'cui_str': 'Stricture of ureter'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0042077', 'cui_str': 'Urology'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0242089', 'cui_str': 'Serology positive'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}]","[{'cui': 'C0441989', 'cui_str': 'Ipsilateral'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0441293', 'cui_str': 'JJ-stent'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439784', 'cui_str': 'Retrograde direction'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0038257', 'cui_str': 'Stent'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1261287', 'cui_str': 'Stenosis'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C4517503', 'cui_str': '1.4'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",70.0,0.0771716,"The overall success rate was significantly better in 2-DJ group than in 1-DJ group (83.9% Vs 53.1%) p =0.009, and also for stricture > 1.5 cm (85.7% Vs 38.5%) p=0.018 respectively.
","[{'ForeName': 'Khaled', 'Initials': 'K', 'LastName': 'Mohyelden', 'Affiliation': 'Fayoum University Faculty of Medicine, 158405, UROLOGY, Fayoum, Egypt; kma02@fayoum.edu.eg.'}, {'ForeName': 'Hussein Aly', 'Initials': 'HA', 'LastName': 'Hussein', 'Affiliation': 'Cairo University Kasr Alainy Faculty of Medicine, 63527, Urology, Cairo, Egypt; drhusseinali2008@yahoo.com.'}, {'ForeName': 'Hisham', 'Initials': 'H', 'LastName': 'El Helaly', 'Affiliation': 'Fayoum University Faculty of Medicine, 158405, Fayoum, Egypt; Hesham.alhelaly@gmail.com.'}, {'ForeName': 'Hamdy', 'Initials': 'H', 'LastName': 'Ibrahim', 'Affiliation': 'Fayoum University Faculty of Medicine, 158405, Urology, Fayoum, Egypt; hamdyibrahim4@yahoo.com.'}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Abdelwahab', 'Affiliation': 'Suez Canal University Faculty of Medicine, 68833, Urology, Ismailia, Egypt; hass75@gmail.com.'}]",Journal of endourology,['10.1089/end.2020.0956']
2252,33096965,Effects of interval-training exercise on people with persistent post-concussive symptoms less than one year: a pilot study.,"This study is to examine the effects of a 12-session moderate intensity-interval-training program with blood flow restriction (BFR) and body cooling (BC) on people with persistent post-concussive symptoms (PPCS) less than one year. A single-blind randomized controlled trial of interval-training exercise with BFR and BC was conducted. Twenty-five adults with PPCS were assigned to the experimental group (n=14) or the control group (n=11). Both groups rode a recumbent elliptical machine for 21 minutes at moderate intensity (65% predicted maximum heart rate) twice a week for six weeks, but only the experimental group received BFR and BC while riding. The variances of overall persistent post-concussive symptom scale scores and its sub-domain scores for individuals during the 6-week intervention and 6-week follow-up period were calculated. During the intervention, the fluctuation of overall symptom severity, severity in cognitive domain and severity in mood domain were significantly less in the experimental group (p=0.03; p=0.02; p=0.02). During the follow-up period, the number of symptoms remained more stable in the experimental group (p=0.02), and a trend toward less fluctuation of symptom severity (p=0.05) was also observed. The reduced number of symptoms in the cognitive and sleep domains remained more stable in the experimental group following the intervention (p=0.007; p=0.02). The severity of mood and sleep symptoms also remained more stable during the follow-up period in the experimental group (p=0.04). More stable recovery was found in individuals who exercised using BFR and BC as compared to those who underwent exercise without BFR and BC. Moderate intensity-interval-training exercise with BFR and BC alleviated post-concussive symptoms in people with PPCS less than one year.",2020,The reduced number of symptoms in the cognitive and sleep domains remained more stable in the experimental group following the intervention (p=0.007; p=0.02).,"['people with persistent post-concussive symptoms (PPCS) less than one year', 'people with persistent post-concussive symptoms less than one year', 'Twenty-five adults with PPCS', 'people with PPCS less than one year']","['interval-training exercise', '12-session moderate intensity-interval-training program with blood flow restriction (BFR) and body cooling (BC']","['number of symptoms', 'number of symptoms in the cognitive and sleep domains', 'severity of mood and sleep symptoms', 'variances of overall persistent post-concussive symptom scale scores and its sub-domain scores', 'fluctuation of symptom severity', 'fluctuation of overall symptom severity, severity in cognitive domain and severity in mood domain']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0546983', 'cui_str': 'Postconcussion syndrome'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0546983', 'cui_str': 'Postconcussion syndrome'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0231239', 'cui_str': 'Fluctuation'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}]",25.0,0.0336548,The reduced number of symptoms in the cognitive and sleep domains remained more stable in the experimental group following the intervention (p=0.007; p=0.02).,"[{'ForeName': 'Yi-Ning', 'Initials': 'YN', 'LastName': 'Wu', 'Affiliation': 'University of Massachusetts Lowell, 14710, Physical Therapy and Kinesiology, 3 Solomont Way, Suite 5, Lowell, Massachusetts, United States, 01854.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Stark', 'Affiliation': 'Lowell, United States; caroline_stark@student.uml.edu.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Gravel', 'Affiliation': 'Concord, United States; jgravel@emersonhosp.org.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'White', 'Affiliation': 'Concord, United States; mawhite@emersonhosp.org.'}, {'ForeName': 'Josh', 'Initials': 'J', 'LastName': 'Avery', 'Affiliation': 'Concord, United States; joshaverypt@gmail.com.'}, {'ForeName': 'Terrie', 'Initials': 'T', 'LastName': 'Enis', 'Affiliation': 'Concord, United States; tenis@emersonhosp.org.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Cantu', 'Affiliation': 'Concord, United States; rcantu@emersonhosp.org.'}]",Journal of neurotrauma,['10.1089/neu.2019.6915']
2253,33096998,Fingerfoods: a feasibility study to enhance fruit and vegetable consumption in Dutch patients with dementia in a nursing home.,"BACKGROUND


Eating problems are highly prevalent in older patients with dementia and as a consequence, these patients are at greater risk of becoming malnourished. Fingerfoods, snacks that can be picked with thumb and forefinger, could be used to counteract malnutrition in patients with dementia. The aim of this feasibility study was to evaluate whether providing fruit and vegetable rich fingerfoods in the form of recognizable and familiar snacks on top of the normal intake was feasible for both patients with dementia and caregivers as a means to increase patients' nutritional status.
METHODS


Institutionalised patients with dementia (N = 15, 93% female, mean age = 85 years) were included in this feasibility study in the Netherlands. The residents received their regular diet supplemented with fingerfoods, comprising quiches and cakes rich in fruit or vegetables, for 6 weeks. Daily fingerfood consumption together with compensation behaviour at dinner of residents was administered with a checklist and food diaries at the start and end of the intervention as dose delivered. Furthermore, caregivers were asked to fill out a feedback form at the end of the intervention to measure fidelity and appreciation of the intervention.
RESULTS


Patients consumed on average 1.4 pieces (70 g) of fingerfoods daily, containing 41 g of fruit and/or vegetables. Fruit and vegetable consumption increased during the provision of the fingerfoods and the residents seemed not to compensate this intake during the rest of the day. The intervention was generally positively received by the majority of caregivers, depending on the type of fingerfood and state of the resident.
CONCLUSION


This feasibility study showed that providing recognizable fruit and vegetable rich fingerfoods to patients with dementia seems feasible for both patients and caregivers and could provide a pragmatic approach to enhance fruit and vegetable consumption and total food intake in institutionalized elderly. In an up-scaled study, effects of fingerfoods on nutritional status and quality of life should be investigated.",2020,"The intervention was generally positively received by the majority of caregivers, depending on the type of fingerfood and state of the resident.
","['patients with dementia', 'Institutionalised patients with dementia (N\u2009=\u200915, 93% female, mean age\u2009=\u200985\u2009years', ""patients with dementia and caregivers as a means to increase patients' nutritional status"", 'Dutch patients with dementia in a nursing home', 'institutionalized elderly', 'older patients with dementia']","['enhance fruit and vegetable consumption', 'regular diet supplemented with fingerfoods, comprising quiches and cakes rich in fruit or vegetables', 'recognizable fruit and vegetable rich fingerfoods', 'providing fruit and vegetable rich fingerfoods']","['Fruit and vegetable consumption', 'nutritional status and quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0562359', 'cui_str': 'Institutionalized'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0184625', 'cui_str': 'Normal diet'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0453457', 'cui_str': 'Quiche'}, {'cui': 'C0452597', 'cui_str': 'Cake'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}]","[{'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.0242008,"The intervention was generally positively received by the majority of caregivers, depending on the type of fingerfood and state of the resident.
","[{'ForeName': 'Annemijn', 'Initials': 'A', 'LastName': 'Visscher', 'Affiliation': 'Department of Nutrition and Health, Louis Bolk Instituut, Bunnik, The Netherlands.'}, {'ForeName': 'Marieke C E', 'Initials': 'MCE', 'LastName': 'Battjes-Fries', 'Affiliation': 'Department of Nutrition and Health, Louis Bolk Instituut, Bunnik, The Netherlands. m.battjes@louisbolk.nl.'}, {'ForeName': 'Ondine', 'Initials': 'O', 'LastName': 'van de Rest', 'Affiliation': 'Division of Human Nutrition and Health, Wageningen University, Wageningen, The Netherlands.'}, {'ForeName': 'Olga N', 'Initials': 'ON', 'LastName': 'Patijn', 'Affiliation': 'Department of Nutrition and Health, Louis Bolk Instituut, Bunnik, The Netherlands.'}, {'ForeName': 'Mascha', 'Initials': 'M', 'LastName': 'van der Lee', 'Affiliation': 'ZuidOostZorg, Drachten, The Netherlands.'}, {'ForeName': 'Nienke', 'Initials': 'N', 'LastName': 'Wijma-Idsinga', 'Affiliation': 'ZuidOostZorg, Drachten, The Netherlands.'}, {'ForeName': 'Gerda K', 'Initials': 'GK', 'LastName': 'Pot', 'Affiliation': 'Department of Nutrition and Health, Louis Bolk Instituut, Bunnik, The Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Voshol', 'Affiliation': 'Department of Nutrition and Health, Louis Bolk Instituut, Bunnik, The Netherlands.'}]",BMC geriatrics,['10.1186/s12877-020-01792-5']
2254,33096745,Effects of Growth Hormone Treatment and Rehabilitation in Incomplete Chronic Traumatic Spinal Cord Injury: Insight from Proteome Analysis.,"Despite promising advances in the medical management of spinal cord injury (SCI), there is still no available effective therapy to repair the neurological damage in patients who experience this life-transforming condition. Recently, we performed a phase II/III placebo-controlled randomized trial of safety and efficacy of growth hormone (GH) treatment in incomplete chronic traumatic spinal cord injury. The main findings were that the combined treatment of GH plus rehabilitation treatment is feasible and safe, and that GH but not placebo slightly improves the SCI individual motor score. Moreover, we found that an intensive and long-lasting rehabilitation program per se increases the functional outcome of SCI individuals. To understand the possible mechanisms of the improvement due to GH treatment (motor score) and due to rehabilitation (functional outcome), we used a proteomic approach. Here, we used a multiple proteomic strategy to search for recovery biomarkers in blood plasma with the potential to predict response to somatropin treatment and to delayed intensive rehabilitation. Forty-six patients were recruited and followed for a minimum period of 1 year. Patients were classified into two groups based on their treatment: recombinant somatropin (0.4 mg) or placebo. Both groups received rehabilitation treatment. Our strategy allowed us to perform one of the deepest plasma proteomic analyses thus far, which revealed two proteomic signatures with predictive value: (i) response to recombinant somatropin treatment and (ii) response to rehabilitation. The proteins implicated in these signatures are related to homeostasis, inflammation, and coagulation functions. These findings open novel possibilities to assess and therapeutically manage patients with SCI, which could have a positive impact on their clinical response.",2020,Patients were classified into two groups based on their treatment: recombinant somatropin (0.4 mg) or placebo.,"['incomplete chronic traumatic spinal cord injury', 'Forty-six patients were recruited and followed for a minimum period of 1 year', 'Incomplete Chronic Traumatic Spinal Cord Injury', 'spinal cord injury (SCI']","['rehabilitation treatment', 'recombinant somatropin', 'placebo', 'Growth Hormone Treatment and Rehabilitation', 'growth hormone (GH) treatment']","['SCI individual motor score', 'functional outcome']","[{'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0169964', 'cui_str': 'Somatropin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0037663', 'cui_str': 'Somatotropin'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",46.0,0.0323718,Patients were classified into two groups based on their treatment: recombinant somatropin (0.4 mg) or placebo.,"[{'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Martin-Rojas', 'Affiliation': 'Department of Vascular Physiopathology, Hospital Nacional de Paraplejicos (HNP), SESCAM, 45071 Toledo, Spain.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Sastre-Oliva', 'Affiliation': 'Department of Vascular Physiopathology, Hospital Nacional de Paraplejicos (HNP), SESCAM, 45071 Toledo, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Esclarín-Ruz', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Hospital Nacional de Parapléjicos, SESCAM, 45071 Toledo, Spain.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Gil-Dones', 'Affiliation': 'Department of Vascular Physiopathology, Hospital Nacional de Paraplejicos (HNP), SESCAM, 45071 Toledo, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Mourino-Alvarez', 'Affiliation': 'Department of Vascular Physiopathology, Hospital Nacional de Paraplejicos (HNP), SESCAM, 45071 Toledo, Spain.'}, {'ForeName': 'Nerea', 'Initials': 'N', 'LastName': 'Corbacho-Alonso', 'Affiliation': 'Department of Vascular Physiopathology, Hospital Nacional de Paraplejicos (HNP), SESCAM, 45071 Toledo, Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Moreno-Luna', 'Affiliation': 'Department of Vascular Physiopathology, Hospital Nacional de Paraplejicos (HNP), SESCAM, 45071 Toledo, Spain.'}, {'ForeName': 'German', 'Initials': 'G', 'LastName': 'Hernandez-Fernandez', 'Affiliation': 'Department of Vascular Physiopathology, Hospital Nacional de Paraplejicos (HNP), SESCAM, 45071 Toledo, Spain.'}, {'ForeName': 'Juan Antonio', 'Initials': 'JA', 'LastName': 'Lopez', 'Affiliation': 'Unidad de Proteomica CNIC, 28029 Madrid, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Oliviero', 'Affiliation': 'FENNSI Group, Hospital Nacional de Parapléjicos, SESCAM, 45071 Toledo, Spain.'}, {'ForeName': 'María G', 'Initials': 'MG', 'LastName': 'Barderas', 'Affiliation': 'Department of Vascular Physiopathology, Hospital Nacional de Paraplejicos (HNP), SESCAM, 45071 Toledo, Spain.'}]",Journal of personalized medicine,['10.3390/jpm10040183']
2255,33096999,Correction to: Landmark-guided versus modified ultrasound-assisted Paramedian techniques in combined spinal-epidural anesthesia for elderly patients with hip fractures: a randomized controlled trial.,An amendment to this paper has been published and can be accessed via the original article.,2020,An amendment to this paper has been published and can be accessed via the original article.,['elderly patients with hip fractures'],"['combined spinal-epidural anesthesia', 'Landmark-guided versus modified ultrasound-assisted Paramedian techniques']",[],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0002913', 'cui_str': 'Epidural anesthesia'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0441993', 'cui_str': 'Paramedian approach'}, {'cui': 'C0025664', 'cui_str': 'methods'}]",[],,0.0490794,An amendment to this paper has been published and can be accessed via the original article.,"[{'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Qu', 'Affiliation': 'Guangzhou University of Chinese Medicine, Guangzhou, 510405, Guangdong, China.'}, {'ForeName': 'Luying', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Guangzhou University of Chinese Medicine, Guangzhou, 510405, Guangdong, China.'}, {'ForeName': 'Yuling', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Guangzhou University of Chinese Medicine, Guangzhou, 510405, Guangdong, China.'}, {'ForeName': 'Mengting', 'Initials': 'M', 'LastName': 'Jiang', 'Affiliation': 'Guangzhou University of Chinese Medicine, Guangzhou, 510405, Guangdong, China.'}, {'ForeName': 'Caineng', 'Initials': 'C', 'LastName': 'Wu', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, 510405, Guangdong, China.'}, {'ForeName': 'Wuhua', 'Initials': 'W', 'LastName': 'Ma', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, 510405, Guangdong, China.'}, {'ForeName': 'Yuhui', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, 510405, Guangdong, China. liliuyuhui@126.com.'}]",BMC anesthesiology,['10.1186/s12871-020-01183-8']
2256,33097016,Spillover HIV prevention effects of a cash transfer trial in East Zimbabwe: evidence from a cluster-randomised trial and general-population survey.,"BACKGROUND


Benefits of cash transfers (CTs) for HIV prevention have been demonstrated largely in purposively designed trials, commonly focusing on young women. It is less clear if CT interventions not designed for HIV prevention can have HIV-specific effects, including adverse effects. The cluster-randomised Manicaland Cash Transfer Trial (2010-11) evaluated effects of CTs on children's (2-17 years) development in eastern Zimbabwe. We evaluated whether this CT intervention with no HIV-specific objectives had unintended HIV prevention spillover effects (externalities).
METHODS


Data on 2909 individuals (15-54 years) living in trial households were taken from a general-population survey, conducted simultaneously in the same communities as the Manicaland Trial. Average treatment effects (ATEs) of CTs on sexual behaviour (any recent sex, condom use, multiple partners) and secondary outcomes (mental distress, school enrolment, and alcohol/cigarette/drug consumption) were estimated using mixed-effects logistic regressions (random effects for study site and intervention cluster), by sex and age group (15-29; 30-54 years). Outcomes were also evaluated with a larger synthetic comparison group created through propensity score matching.
RESULTS


CTs did not affect sexual debut but reduced having any recent sex (past 30 days) among young males (ATE: - 11.7 percentage points [PP] [95% confidence interval: -26.0PP, 2.61PP]) and females (- 5.68PP [- 15.7PP, 4.34PP]), with similar but less uncertain estimates when compared against the synthetic comparison group (males: -9.68PP [- 13.1PP, - 6.30PP]; females: -8.77PP [- 16.3PP, - 1.23PP]). There were no effects among older individuals. Young (but not older) males receiving CTs reported increased multiple partnerships (8.49PP [- 5.40PP, 22.4PP]; synthetic comparison: 10.3PP (1.27PP, 19.2PP). No impact on alcohol, cigarette, or drug consumption was found. There are indications that CTs reduced psychological distress among young people, although impacts were small. CTs increased school enrolment in males (11.5PP [3.05PP, 19.9PP]). Analyses with the synthetic comparison group (but not the original control group) further indicated increased school enrolment among females (5.50PP [1.62PP, 9.37PP]) and condom use among younger and older women receiving CTs (9.38PP [5.90PP, 12.9PP]; 5.95PP [1.46PP, 10.4PP]).
CONCLUSIONS


Non-HIV-prevention CT interventions can have HIV prevention outcomes, including reduced sexual activity among young people and increased multiple partnerships among young men. No effects on sexual debut or alcohol, cigarette, or drug consumption were observed. A broad approach is necessary to evaluate CT interventions to capture unintended outcomes, particularly in economic evaluations.
TRIAL REGISTRATION


ClinicalTrials.gov , NCT00966849 . Registered August 27, 2009.",2020,"Average treatment effects (ATEs) of CTs on sexual behaviour (any recent sex, condom use, multiple partners) and secondary outcomes (mental distress, school enrolment, and alcohol/cigarette/drug consumption) were estimated using mixed-effects logistic regressions (random effects for study site and intervention cluster), by sex and age group (15-29; 30-54 years).","[""children's (2-17\u2009years) development in eastern Zimbabwe"", 'young women', 'group (males: -9.68PP [-\u200913.1PP, -\u20096.30PP]; females: -8.77PP [-\u200916.3PP, -\u20091.23PP', 'East Zimbabwe', 'Young (but not older) males receiving', 'Data on 2909 individuals (15-54\u2009years) living in trial households were taken from a general-population survey, conducted simultaneously in the same communities as the Manicaland Trial']","['cash transfers (CTs', 'CT intervention', 'synthetic comparison', 'CTs']","['alcohol, cigarette, or drug consumption', 'psychological distress', 'sexual debut or alcohol, cigarette, or drug consumption', 'CTs increased school enrolment', 'sexual behaviour (any recent sex, condom use, multiple partners) and secondary outcomes (mental distress, school enrolment, and alcohol/cigarette/drug consumption', 'school enrolment', 'sexual activity']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0043476', 'cui_str': 'Zimbabwe'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0026767', 'cui_str': 'Multiple Partners'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0235109', 'cui_str': 'Mental distress'}]",2909.0,0.0379822,"Average treatment effects (ATEs) of CTs on sexual behaviour (any recent sex, condom use, multiple partners) and secondary outcomes (mental distress, school enrolment, and alcohol/cigarette/drug consumption) were estimated using mixed-effects logistic regressions (random effects for study site and intervention cluster), by sex and age group (15-29; 30-54 years).","[{'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Schaefer', 'Affiliation': 'MRC Centre for Global Infectious Disease Analysis, Department of Infectious Disease Epidemiology, Imperial College London, London, UK. r.schaefer@imperial.ac.uk.'}, {'ForeName': 'Ranjeeta', 'Initials': 'R', 'LastName': 'Thomas', 'Affiliation': 'Department of Health Policy, London School of Economics and Political Science, London, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Robertson', 'Affiliation': 'Independent, London, UK.'}, {'ForeName': 'Jeffrey W', 'Initials': 'JW', 'LastName': 'Eaton', 'Affiliation': 'MRC Centre for Global Infectious Disease Analysis, Department of Infectious Disease Epidemiology, Imperial College London, London, UK.'}, {'ForeName': 'Phyllis', 'Initials': 'P', 'LastName': 'Mushati', 'Affiliation': 'Independent, Harare, Zimbabwe.'}, {'ForeName': 'Constance', 'Initials': 'C', 'LastName': 'Nyamukapa', 'Affiliation': 'MRC Centre for Global Infectious Disease Analysis, Department of Infectious Disease Epidemiology, Imperial College London, London, UK.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Hauck', 'Affiliation': 'MRC Centre for Global Infectious Disease Analysis, Department of Infectious Disease Epidemiology, Imperial College London, London, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Gregson', 'Affiliation': 'MRC Centre for Global Infectious Disease Analysis, Department of Infectious Disease Epidemiology, Imperial College London, London, UK.'}]",BMC public health,['10.1186/s12889-020-09667-5']
2257,33097017,Lactobacillus rhamnosus PL1 and Lactobacillus plantarum PM1 versus placebo as a prophylaxis for recurrence urinary tract infections in children: a study protocol for a randomised controlled trial.,"BACKGROUND


Urinary tract infections (UTIs) are one of the most common bacterial infections in children. In children < 7 years of age, the prevalence of one episode of symptomatic UTI has been estimated at 3-7% in girls and 1-2% in boys, whereas 8-30% of them will have one or more episodes of UTI. The use of some probiotics appears to reduce the risk of recurrence of UTIs. Since the effects of probiotics are strain-specific, the efficacy and safety of each strain has to be assessed. The main aim of this study is to determine whether probiotics (containing Lactobacillus rhamnosus PL1 and Lactobacillus plantarum PM1) therapy are effective in preventing UTI in children compared to placebo.
METHOD


A superiority, double-blind, randomised, controlled trial is being conducted. One hundred and six patients aged 3 to 18 years with recurrent UTIs in last year (defined as: ≥ 2 episodes of UTI with acute pyelonephritis/upper UTI; or 1 episode of UTI with acute pyelonephritis and ≥ 1 episodes of UTI with cystitis/lower UTI; or ≥ 3 episodes of UTI with cystitis/lower UTI) or children with ≥ 1 infection in the upper urinary tract and ≥ 1 of recurrent UTIs risk factors (congenital anomalies of the kidney and urinary tract, constipation, bladder dysfunction, myelomeningocele, sexual activity in girls) will be randomly assigned to receive a 90-day prophylaxis arm (probiotic containing L. rhamnosus PL1 and L. plantarum PM1) or a 90-day placebo arm. The primary outcome measure will be the frequency of recurrence of UTI during the intervention and in the period 9 months after the intervention.
DISCUSSION


The findings of this randomised controlled trial (RCT), whether positive or negative, will contribute to the formulation of further recommendations on prevention of recurrent UTIs in children.
TRIAL REGISTRATION NUMBER


NCT03462160, date of trial registration 12th March 2018.",2020,"The primary outcome measure will be the frequency of recurrence of UTI during the intervention and in the period 9 months after the intervention.
","['children', 'One hundred and six patients aged 3 to 18\xa0years with recurrent UTIs in last year (defined as:\u2009≥\u20092 episodes of UTI with acute pyelonephritis/upper UTI; or 1 episode of UTI with acute pyelonephritis and\u2009≥\u20091 episodes of UTI with cystitis/lower UTI; or\u2009≥\u20093 episodes of UTI with cystitis/lower UTI) or children with\u2009≥\u20091 infection in the upper urinary tract and\u2009≥\u20091 of recurrent UTIs risk factors (congenital anomalies of the kidney and urinary tract, constipation, bladder dysfunction, myelomeningocele, sexual activity in girls']","['Lactobacillus rhamnosus PL1 and Lactobacillus plantarum PM1 versus placebo', 'probiotics (containing Lactobacillus rhamnosus PL1 and Lactobacillus plantarum PM1) therapy', '90-day prophylaxis arm (probiotic containing L. rhamnosus PL1 and L. plantarum PM1']","['recurrence urinary tract infections', 'frequency of recurrence of UTI']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0262655', 'cui_str': 'Recurrent urinary tract infection'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0520575', 'cui_str': 'Acute pyelonephritis'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0010692', 'cui_str': 'Cystitis'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C1508753', 'cui_str': 'Urinary system structure'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C1968949', 'cui_str': 'Cakut'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0232841', 'cui_str': 'Bladder dysfunction'}, {'cui': 'C0025312', 'cui_str': 'Meningomyelocele'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0317597', 'cui_str': 'Lactobacillus casei rhamnosus'}, {'cui': 'C0317608', 'cui_str': 'Lactobacillus plantarum'}, {'cui': 'C0456957', 'cui_str': 'Metastasis stage pM1'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C1231534', 'cui_str': 'Curtobacterium plantarum'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",106.0,0.221633,"The primary outcome measure will be the frequency of recurrence of UTI during the intervention and in the period 9 months after the intervention.
","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Daniel', 'Affiliation': 'Department of Paediatric Nephrology, Medical University of Warsaw, Żwirki i Wigury 63A, 02-091, Warsaw, Poland.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Szymanik-Grzelak', 'Affiliation': 'Department of Paediatric Nephrology, Medical University of Warsaw, Żwirki i Wigury 63A, 02-091, Warsaw, Poland. h.szymanik@interia.pl.'}, {'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Turczyn', 'Affiliation': 'Department of Paediatric Nephrology, Medical University of Warsaw, Żwirki i Wigury 63A, 02-091, Warsaw, Poland.'}, {'ForeName': 'Małgorzata', 'Initials': 'M', 'LastName': 'Pańczyk-Tomaszewska', 'Affiliation': 'Department of Paediatric Nephrology, Medical University of Warsaw, Żwirki i Wigury 63A, 02-091, Warsaw, Poland.'}]",BMC urology,['10.1186/s12894-020-00723-1']
2258,33097026,Cost-utility and cost-benefit analyses of school-based obesity prevention program.,"BACKGROUND


Economic evaluation of school-based obesity interventions could provide support for public health decision of obesity prevention. This study is to perform cost-utility and cost-benefit assessment of three school-based childhood obesity interventions including nutrition education intervention (NE), physical activity intervention (PA) and comprehensive intervention (both NE and PA, CNP) with secondary data analysis of one randomized controlled trial.
METHODS


The standard cost-effectiveness analysis methods were employed from a societal perspective to the health outcome and costs that are attributable to the intervention. NE, PA and CNP were carried out separately for 2 semesters for childhood obesity interventions in primary schools. The additional quality-adjusted life years (QALYs) resulting from the interventions were measured as the health outcome. A cost-utility ratio (CUR) and A cost-benefit ratio (CBR) was calculated as the ratio of implementation costs to the total medical and productivity loss costs averted by the interventions.
RESULTS


The CUR and CBR were ¥11,505.9 ($1646.0) per QALY and ¥1.2 benefit per ¥1 cost respectively, and the net saving was ¥73,659.6 ($10,537.9). The CUR and CBR for nutrition education and physical activity interventions were ¥21,316.4 ($3049.6) per QALY and ¥0.7 benefit per ¥1 cost, ¥28,417.1 ($4065.4) per QALY and ¥0.4 benefit per ¥1 cost, respectively (in 2019 RMB). Compared with PA intervention, the ICERs were ¥10,335.2 ($1478.6) and 4626.3 ($661.8) for CNP and NE respectively. The CBR was ¥1.2, 0.7, and 0.4 benefits per ¥1 cost for CNP, NE, and PA interventions, respectively. Net estimated savings were achieved only through CNP intervention, amounting to ¥73,659.6 ($10,537.9).
CONCLUSIONS


Comprehensive school-based obesity intervention is a beneficial investment that is both cost-effective and cost saving. Compared with PA intervention, both CNP and NE intervention were more cost-effective.",2020,"Compared with PA intervention, the ICERs were ¥10,335.2 ($1478.6) and 4626.3 ($661.8) for CNP and NE respectively.",[],"['school-based obesity prevention program', 'nutrition education intervention (NE), physical activity intervention (PA) and comprehensive intervention (both NE and PA, CNP', 'CNP and NE intervention', 'Comprehensive school-based obesity intervention', 'NE, PA and CNP']","['cost-utility ratio (CUR) and A cost-benefit ratio (CBR', 'cost-effective', 'ICERs', 'CUR and CBR', 'Net estimated savings']",[],"[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1511518', 'cui_str': 'Copy Number Polymorphisms'}, {'cui': 'C0557796', 'cui_str': 'Comprehensive school'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0010187', 'cui_str': 'Benefits and Costs'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0036245', 'cui_str': 'Savings'}]",,0.0269197,"Compared with PA intervention, the ICERs were ¥10,335.2 ($1478.6) and 4626.3 ($661.8) for CNP and NE respectively.","[{'ForeName': 'Haiquan', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Institute of Food and Nutrition Development, Ministry of Agriculture and Rural Affairs, Beijing, China.'}, {'ForeName': 'Yanping', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Nutrition, Harvard T. H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Songming', 'Initials': 'S', 'LastName': 'Du', 'Affiliation': 'Chinese Nutrition Society, Beijing, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'National Institute for Nutrition and Health, Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Ailing', 'Initials': 'A', 'LastName': 'Liu', 'Affiliation': 'National Institute for Nutrition and Health, Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Junmao', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Institute of Food and Nutrition Development, Ministry of Agriculture and Rural Affairs, Beijing, China.'}, {'ForeName': 'Guansheng', 'Initials': 'G', 'LastName': 'Ma', 'Affiliation': 'Department of Nutrition and Food Hygiene, School of Public Health, Peking University, 38 Xue Yuan Road, Beijing, 100191, China. mags@bjmu.edu.cn.'}]",BMC public health,['10.1186/s12889-020-09718-x']
2259,33097365,A Voice Rehabilitation Protocol With the Semioccluded Ventilation Mask in Subjects With Symptoms of Vocal Fatigue and Phonatory Effort.,"PURPOSE


The present study was designed to assess the efficacy of a six-session physiologic voice therapy program with the semioccluded ventilation mask (SOVM) in a group of subjects with voice complaints (vocal effort and fatigue).
METHODS


Thirty-four participants with functional dysphonia were randomly assigned to one of two treatment groups: (1) voice treatment with physiologic voice therapy plus vocal hygiene program (n = 17), and (2) vocal hygiene program only (n = 17). Laryngoscopic assessment was performed in all subjects to confirm laryngeal diagnosis. Before and after voice therapy, participants underwent aerodynamic assessment. The Voice Handicap Index (VHI), Vocal Tract Discomfort Scale (VTDS), and self-assessment of resonant voice were also performed. The treatment included six voice therapy sessions. For the experimental group, the exercises consisted of a sequence of seven phonatory tasks performed with the SOVM. Comparison for all variables was performed between experimental group and control group.
RESULTS


Statistical analysis showed significant improvements for experimental group for VHI (decrease), VTDS (decrease), and self-perception of resonant voice quality (increase). Significant decrease for experimental group was observed in subglottic pressure and phonation threshold pressure.
CONCLUSION


Physiologic voice therapy based on the SOVM with connected speech exercises seems to be an effective tool to improve voice in subjects diagnosed with voice complaints. Apparently, improvements are reflected in both subjective and objective outcomes. A reduction in phonatory effort and perceptual aspects of vocal fatigue are the main subjective improvements. A decrease in air pressure-related variables seems to be the most important objective change after voice therapy.",2020,"Significant decrease for experimental group was observed in subglottic pressure and phonation threshold pressure.
","['subjects with voice complaints (vocal effort and fatigue', 'Thirty-four participants with functional dysphonia', 'subjects diagnosed with voice complaints', 'Subjects With Symptoms of Vocal Fatigue and Phonatory Effort']","['SOVM with connected speech exercises', 'six-session physiologic voice therapy program with the semioccluded ventilation mask (SOVM', 'voice treatment with physiologic voice therapy plus vocal hygiene program (n\xa0=\xa017), and (2) vocal hygiene program', 'Physiologic voice therapy']","['air pressure', 'Voice Handicap Index (VHI), Vocal Tract Discomfort Scale (VTDS), and self-assessment of resonant voice', 'Laryngoscopic assessment', 'VHI (decrease), VTDS (decrease), and self-perception of resonant voice quality (increase', 'subglottic pressure and phonation threshold pressure']","[{'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0264622', 'cui_str': 'Psychogenic voice disorder'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0241700', 'cui_str': 'Vocal fatigue'}]","[{'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0589262', 'cui_str': 'Speech exercises'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C2202690', 'cui_str': 'Voice therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}]","[{'cui': 'C0001876', 'cui_str': 'Air pressure'}, {'cui': 'C2985106', 'cui_str': 'Voice handicap index'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0036591', 'cui_str': 'Self Assessment'}, {'cui': 'C0577554', 'cui_str': 'Resonant'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0242498', 'cui_str': 'Self-image'}, {'cui': 'C0042943', 'cui_str': 'Vocal quality'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0234833', 'cui_str': 'Subglottic pressure'}, {'cui': 'C0031577', 'cui_str': 'Laryngeal voice function'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}]",34.0,0.0111302,"Significant decrease for experimental group was observed in subglottic pressure and phonation threshold pressure.
","[{'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Guzman', 'Affiliation': 'Department of Communication Sciences and Disorders, Universidad de los Andes, Chile. Electronic address: guzmann.marcoa@gmail.com.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Calvache', 'Affiliation': 'Department of Communication Sciences and Disorders, Corporacion Universitaria Iberoamericana, Vocology Center, Bogota, Colombia.'}, {'ForeName': 'Fernanda', 'Initials': 'F', 'LastName': 'Pacheco', 'Affiliation': 'Clinica Las Condes, Santiago, Chile.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Ugalde', 'Affiliation': 'Clinica Bicentenario, Santiago, Chile.'}, {'ForeName': 'Vasti', 'Initials': 'V', 'LastName': 'Ortiz', 'Affiliation': 'Department of Communication Sciences and Disorders, Universidad de Chile, Santiago, Chile.'}, {'ForeName': 'Juan Del', 'Initials': 'JD', 'LastName': 'Lago', 'Affiliation': 'Department of Otolaryngology, Clínica Universidad de los Andes, Santiago, Chile.'}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Bobadilla', 'Affiliation': 'Department of Communication Sciences and Disorders, Universidad de los Andes, Santiago, Chile.'}]",Journal of voice : official journal of the Voice Foundation,['10.1016/j.jvoice.2020.10.011']
2260,33097366,Effects of Sequentially Combined Arytenoid Adduction and Injection Laryngoplasty in Patients With Unilateral Vocal Fold Paralysis.,"OBJECTIVES


Arytenoid adduction (AA) and injection laryngoplasty (IL) are major surgical options for the treatment of unilateral vocal fold paralysis (UVFP). AA is a laryngeal framework surgery and IL is a soft-tissue augmentation procedure. Therefore, the effect of each intervention will not be substitutive but complementary to the other.
METHODS


Patients who received AA and IL were enrolled (N = 43). Mean age was 60.1 ± 12.7 years. Objective and subjective voice parameters including maximum phonation time (MPT), jitter, shimmer, noise to harmonic ratio (NHR), grade of dysphonia (G), and voice handicap index (VHI)-30 were collected preoperatively and 6 months postoperatively. AA and IL were sequentially performed with time interval; 28 (65.1%) patients received IL first followed by AA (IL+AA group) and 15 (34.9%) had AA followed by IL (AA+IL group). Time interval between first and second procedures was 9.9 ± 14.6 months.
RESULTS


MPT, jitter, shimmer, NHR, G and VHI-30 significantly improved by both first and second procedures (P < 0.001). When we evaluated IL+AA group and AA+IL group separately, the final outcomes of MPT, jitter, G, and VHI-30 between the two groups were not significantly different. When the overall effects of IL and AA were compared, MPT significantly improved with AA than with IL (P < 0.001).
CONCLUSION


In patients with unilateral vocal fold paralysis, sequential AA and IL (or IL and AA) provided additional improvement of subjective and objective voice parameters. Final outcomes of the two combined procedures resulted in similar degree of voice improvement regardless of the order of procedure.
LEVEL OF EVIDENCE


4.",2020,"RESULTS


MPT, jitter, shimmer, NHR, G and VHI-30 significantly improved by both first and second procedures (P < 0.001).","['Mean age was 60.1 ± 12.7 years', 'Patients With Unilateral Vocal Fold Paralysis', 'Patients who received AA and IL were enrolled (N\xa0=\xa043', 'unilateral vocal fold paralysis (UVFP']","['IL+AA', 'Sequentially Combined Arytenoid Adduction and Injection Laryngoplasty', 'MPT', 'Arytenoid adduction (AA) and injection laryngoplasty (IL']","['Time interval', 'MPT, jitter, shimmer, NHR, G and VHI-30', 'similar degree of voice improvement regardless of the order of procedure', 'maximum phonation time (MPT), jitter, shimmer, noise to harmonic ratio (NHR), grade of dysphonia (G), and voice handicap index (VHI)-30']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517546', 'cui_str': '12.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0042930', 'cui_str': 'Vocal cord structure'}, {'cui': 'C0237766', 'cui_str': 'Hysterical paralysis'}, {'cui': 'C0003943', 'cui_str': 'Arytenoid cartilage structure'}, {'cui': 'C0231457', 'cui_str': 'Adduction'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0189299', 'cui_str': 'Repair of larynx'}]","[{'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0231457', 'cui_str': 'Adduction'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0003943', 'cui_str': 'Arytenoid cartilage structure'}, {'cui': 'C0189299', 'cui_str': 'Repair of larynx'}, {'cui': 'C0234778', 'cui_str': 'Maximum phonation time'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0234778', 'cui_str': 'Maximum phonation time'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C2985106', 'cui_str': 'Voice handicap index'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0019825', 'cui_str': 'Hoarse'}]",,0.144898,"RESULTS


MPT, jitter, shimmer, NHR, G and VHI-30 significantly improved by both first and second procedures (P < 0.001).","[{'ForeName': 'Nayeon', 'Initials': 'N', 'LastName': 'Choi', 'Affiliation': 'Department of Otorhinolaryngology - Head and Neck Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea; Department of Otorhinolaryngology - Head and Neck Surgery, Jeju National University Hospital, Jeju National University School of Medicine, Jeju, South Korea.'}, {'ForeName': 'Younghac', 'Initials': 'Y', 'LastName': 'Kim', 'Affiliation': 'Department of Otorhinolaryngology - Head and Neck Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Bok Hyun', 'Initials': 'BH', 'LastName': 'Song', 'Affiliation': 'Department of Otorhinolaryngology - Head and Neck Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Sung Min', 'Initials': 'SM', 'LastName': 'Koh', 'Affiliation': 'Department of Otorhinolaryngology - Head and Neck Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Woori', 'Initials': 'W', 'LastName': 'Park', 'Affiliation': 'Department of Otorhinolaryngology - Head and Neck Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Hack Jung', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Department of Otorhinolaryngology - Head and Neck Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Young-Ik', 'Initials': 'YI', 'LastName': 'Son', 'Affiliation': 'Department of Otorhinolaryngology - Head and Neck Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea. Electronic address: yison@skku.edu.'}]",Journal of voice : official journal of the Voice Foundation,['10.1016/j.jvoice.2020.10.004']
2261,33097384,Diabetes status modifies the efficacy of home-based kidney care for Zuni Indians in a randomized controlled trial.,"BACKGROUND


Home-Based Kidney Care (HBKC) is a pragmatic treatment approach that addresses patient preferences and cultural barriers to healthcare. We previously reported the results of a clinical trial of HBKC vs. usual care in a cohort of Zuni Indians in New Mexico. This study investigated the potential for differential efficacy of HBKC vs. usual care according to type 2 diabetes (T2DM) status.
METHODS


We analyzed the data from all individuals who participated in a randomized clinical trial that compared HBKC to usual care among patients with CKD, and assessed whether the effect of the HBKC intervention affected the subset of patients with T2DM differently than those individuals without T2DM. We used linear regression models to estimate the effect of HBKC on improvement in Patient Activation Measure (PAM) total scores within the groups of participants defined by T2DM status, and to compare the effects between these two groups. We used generalized estimating equations (GEE) to account for household clustering.
RESULTS


The original study enrolled 63 participants into the HBKC group, and 62 into the usual care. Ninety-eight of these individuals completed the 12-month intervention, 50 in the HBKC group and 48 in the usual care group. The present study compared the intervention effect in the 56 participants with T2DM (24 participants in the HBKC group and 32 in usual care) to the intervention effect in the 42 participants without T2DM (26 participants in the HBKC group and 16 in usual care). Those with T2DM who received the HBKC intervention experienced an average increase in PAM total scores of 16.0 points (95% Confidence Interval: 8.8-23.1) more than those with T2DM who were in the usual care group. For those without T2DM, the intervention had essentially no effect, with those who received the HBKC intervention having an average PAM total scores that was 1.4 points (95% C.I.: -12.4 to 9.6) lower than those who received usual care. There was a significantly different HBKC treatment effect by T2DM status (p = 0.02).
CONCLUSION


This secondary analysis suggests that the effectiveness of this HBKC intervention on increasing patient activation is most notable among those CKD patients who also have T2DM.",2020,Those with T2DM who received the HBKC intervention experienced an average increase in PAM total scores of 16.0 points (95% Confidence Interval: 8.8-23.1) more than those with T2DM who were in the usual care group.,"['Ninety-eight of these individuals completed the 12-month intervention, 50 in the HBKC group and 48 in the usual care group', '63 participants into the HBKC group, and 62 into the usual care', 'CKD patients who also have T2DM', '56 participants with T2DM (24 participants in the HBKC group and 32 in usual care) to the intervention effect in the 42 participants without T2DM (26 participants in the HBKC group and 16 in usual care']","['HBKC intervention', 'HBKC vs. usual care', 'HBKC', 'home-based kidney care', 'Home-Based Kidney Care (HBKC']","['average PAM total scores', 'Patient Activation Measure (PAM) total scores', 'patient activation', 'PAM total scores']","[{'cui': 'C4319627', 'cui_str': '98'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C4075707', 'cui_str': 'Patient Activation Measure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3853034', 'cui_str': 'Patient Activation'}]",63.0,0.035233,Those with T2DM who received the HBKC intervention experienced an average increase in PAM total scores of 16.0 points (95% Confidence Interval: 8.8-23.1) more than those with T2DM who were in the usual care group.,"[{'ForeName': 'V Shane', 'Initials': 'VS', 'LastName': 'Pankratz', 'Affiliation': 'Department of Internal Medicine, University of New Mexico Health Sciences Center, Albuquerque, New Mexico, USA.'}, {'ForeName': 'E Eunice', 'Initials': 'EE', 'LastName': 'Choi', 'Affiliation': 'Department of Internal Medicine, University of New Mexico Health Sciences Center, Albuquerque, New Mexico, USA.'}, {'ForeName': 'Fares', 'Initials': 'F', 'LastName': 'Qeadan', 'Affiliation': 'Division of Public Health, Department of Family and Preventative Medicine, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Donica', 'Initials': 'D', 'LastName': 'Ghahate', 'Affiliation': 'Department of Internal Medicine, University of New Mexico Health Sciences Center, Albuquerque, New Mexico, USA.'}, {'ForeName': 'Jeanette', 'Initials': 'J', 'LastName': 'Bobelu', 'Affiliation': 'Department of Internal Medicine, University of New Mexico Health Sciences Center, Albuquerque, New Mexico, USA.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Nelson', 'Affiliation': 'Chronic Kidney Disease Section, Phoenix Epidemiology and Clinical Research Branch, NIDDK, NIH, Phoenix, AZ, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Faber', 'Affiliation': 'Indian Health Service, Zuni Comprehensive Care Center, NM, USA.'}, {'ForeName': 'Vallabh O', 'Initials': 'VO', 'LastName': 'Shah', 'Affiliation': 'Department of Internal Medicine, University of New Mexico Health Sciences Center, Albuquerque, New Mexico, USA. Electronic address: vshah@salud.unm.edu.'}]",Journal of diabetes and its complications,['10.1016/j.jdiacomp.2020.107753']
2262,33097396,Effect of music therapy on anxiety and pain in the critical polytraumatised patient.,"OBJECTIVE


To determine the effectiveness of music therapy on anxiety and pain in critical polytraumatised patients admitted to the resuscitation unit of a tertiary level hospital in Spain.
MATERIAL AND METHOD


Randomised clinical trial conducted in a tertiary level hospital, from June 2016 to May 2018. The study sample was 60 patients, 30 belonging to the intervention group (IG), and 30 to the control group (CG). The IG were given a 30-minute music session and heart rate (HR) and blood pressure (BP) were measured. The VAS (Visual Analogue Scale) was applied for anxiety and pain before and after each session. The same measures and scales were applied in the CG who did not receive a music session. The music session comprised 3 parts: the first was standard music selected by music therapists; the second was personalised, chosen by the patient and the third was a new standard. The intervention took place in a booth with headphones.
RESULTS


Significant changes in anxiety levels (P<.01) were detected in the group of patients undergoing the intervention, measured with the VAS scale for anxiety, and pain levels (P<.01), measured with the VAS scale for pain. No significant differences were found in the physiological parameters of HR and BP.
CONCLUSION


The use of music in critical polytraumatised patients reduces anxiety and pain levels, increasing the patient's well-being and improving the quality of care. Music therapy, therefore, is considered beneficial as a complementary measure in critical care units. It would be worthwhile to continue studies in this and other hospital areas.",2020,"RESULTS


Significant changes in anxiety levels (P<.01) were detected in the group of patients undergoing the intervention, measured with the VAS scale for anxiety, and pain levels (P<.01), measured with the VAS scale for pain.","['tertiary level hospital, from June 2016 to May 2018', '60 patients, 30 belonging to the intervention group (IG), and 30 to the control group (CG', 'critical polytraumatised patients admitted to the resuscitation unit of a tertiary level hospital in Spain']","['music therapy', 'Music therapy']","['anxiety levels', 'VAS scale for anxiety, and pain levels', 'heart rate (HR) and blood pressure (BP', 'anxiety and pain', 'physiological parameters of HR and BP', 'VAS (Visual Analogue Scale', 'VAS scale for pain', 'anxiety and pain levels']","[{'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0037747', 'cui_str': 'Spain'}]","[{'cui': 'C0026868', 'cui_str': 'Music therapy'}]","[{'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.0400033,"RESULTS


Significant changes in anxiety levels (P<.01) were detected in the group of patients undergoing the intervention, measured with the VAS scale for anxiety, and pain levels (P<.01), measured with the VAS scale for pain.","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Contreras-Molina', 'Affiliation': 'Unidad de Reanimación, Complejo Hospitalario Universitario de Albacete, Albacete, España.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Rueda-Núñez', 'Affiliation': 'Unidad de Reanimación, Complejo Hospitalario Universitario de Albacete, Albacete, España.'}, {'ForeName': 'M L', 'Initials': 'ML', 'LastName': 'Pérez-Collado', 'Affiliation': 'Unidad de Reanimación, Complejo Hospitalario Universitario de Albacete, Albacete, España. Electronic address: m.luz.pc1@hotmail.com.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'García-Maestro', 'Affiliation': 'Unidad de Reanimación, Complejo Hospitalario Universitario de Albacete, Albacete, España.'}]",Enfermeria intensiva,['10.1016/j.enfi.2020.03.003']
2263,33097414,Nanoparticle Albumin-bound Paclitaxel Plus Carboplatin Induction Followed by Nanoparticle Albumin-bound Paclitaxel Maintenance in Squamous Non-Small-cell Lung Cancer (ABOUND.sqm): A Phase III Randomized Clinical Trial.,"BACKGROUND


We evaluated maintenance nanoparticle albumin-bound (nab) paclitaxel in the treatment of advanced squamous non-small-cell lung cancer.
PATIENTS AND METHODS


Patients with treatment-naive squamous non-small-cell lung cancer received four 21-day cycles of nab-paclitaxel 100 mg/m 2  on days 1, 8, 15 plus carboplatin area under the curve 6 on day 1 as induction therapy. Patients without disease progression after induction were randomized 2:1 to maintenance nab-paclitaxel 100 mg/m 2  (days 1 and 8 every 21 days) plus best supportive care (BSC) or BSC alone. The primary endpoint was progression-free survival (PFS). Secondary endpoints included safety and overall survival (OS).
RESULTS


Overall, 420 patients had received induction therapy; 202 (nab-paclitaxel plus BSC, 136; BSC, 66) had received maintenance therapy. Enrollment was discontinued after a preplanned interim futility analysis (patients could remain in the study at the investigator's discretion). The median PFS was 3.12 months for nab-paclitaxel plus BSC and 2.60 months for BSC; the difference was not statistically significant (hazard ratio [HR], 0.85; 95% confidence interval [CI], 0.61-1.19; P = .36). The median OS (median follow-up, 24.2 months) was 17.18 months for nab-paclitaxel plus BSC and 12.16 months for BSC (HR, 0.70; 95% CI, 0.48-1.02; nominal P = .07). An updated analysis (median follow-up, 28.4 months) revealed a median OS of 17.61 months for nab-paclitaxel plus BSC and 12.16 months for BSC (HR, 0.68; 95% CI, 0.47-0.98; nominal P = .037). The most frequent grade 3 and 4 treatment-emergent adverse events for the entire study were neutropenia (53.1% [nab-paclitaxel plus BSC] vs. 50.0% [BSC]) and anemia (33.1% [nab-paclitaxel plus BSC] vs. 32.3% [BSC]). Only peripheral neuropathy had occurred in ≥ 5% of patients during maintenance therapy (13.1%; nab-paclitaxel plus BSC).
CONCLUSIONS


The results of the ABOUND.sqm did not meet the primary endpoint of PFS. An updated OS analysis revealed a trend favoring nab-paclitaxel plus BSC.",2020,"The median OS (median follow-up, 24.2 months) was 17.18 months for nab-paclitaxel plus BSC and 12.16 months for BSC (HR, 0.70; 95% CI, 0.48-1.02; nominal P = .07).","['Patients with treatment-naive squamous non-small-cell lung cancer', 'Patients without disease progression after induction were randomized 2:1 to', 'advanced squamous non-small-cell lung cancer', 'Squamous Non-Small-cell Lung Cancer (ABOUND.sqm', '420 patients had received induction therapy; 202 (nab-paclitaxel plus BSC, 136; BSC, 66) had received']","['maintenance nab-paclitaxel 100 mg/m 2  (days 1 and 8 every 21 days) plus best supportive care (BSC) or BSC alone', 'Nanoparticle Albumin-bound Paclitaxel Plus Carboplatin Induction', 'nab-paclitaxel 100 mg/m 2  on days 1, 8, 15 plus carboplatin area under the curve 6 on day 1 as induction therapy', 'Nanoparticle Albumin-bound Paclitaxel Maintenance', 'maintenance therapy', 'maintenance nanoparticle albumin-bound (nab) paclitaxel']","['safety and overall survival (OS', 'anemia', 'median OS', 'neutropenia', 'peripheral neuropathy', 'progression-free survival (PFS', 'median PFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4509816', 'cui_str': 'Squamous non-small cell lung cancer'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C4517774', 'cui_str': '420'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4517568', 'cui_str': '136'}]","[{'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3873150', 'cui_str': 'Every twenty one days'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0344211', 'cui_str': 'Support'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C1450054', 'cui_str': 'Nanoparticles'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0332297', 'cui_str': 'Bounded by'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C1869037', 'cui_str': 'Peripheral neuropathy (SMQ)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",420.0,0.244915,"The median OS (median follow-up, 24.2 months) was 17.18 months for nab-paclitaxel plus BSC and 12.16 months for BSC (HR, 0.70; 95% CI, 0.48-1.02; nominal P = .07).","[{'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Spigel', 'Affiliation': 'Sarah Cannon Research Institute, Nashville, TN. Electronic address: dspigel@tnonc.com.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Jotte', 'Affiliation': 'Rocky Mountain Cancer Centers, Denver, CO.'}, {'ForeName': 'Santiago Ponce', 'Initials': 'SP', 'LastName': 'Aix', 'Affiliation': 'Unidad de Investigación Clínica de Cáncer Pulmón H12O-CNIO, Madrid, Spain.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Gressot', 'Affiliation': 'North Cypress Cancer Center, Cypress, TX.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Morgensztern', 'Affiliation': 'Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'McCleod', 'Affiliation': 'Florida Cancer Specialists, Fort Myers, FL.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Socinski', 'Affiliation': 'AdventHealth Cancer Institute, Orlando, FL.'}, {'ForeName': 'Davey', 'Initials': 'D', 'LastName': 'Daniel', 'Affiliation': 'Tennessee Oncology, Chattanooga, TN.'}, {'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Juan-Vidal', 'Affiliation': 'Hospital Universitari i Politécnic La Fe, Valencia, Spain.'}, {'ForeName': 'Kathryn F', 'Initials': 'KF', 'LastName': 'Mileham', 'Affiliation': 'Levine Cancer Institute, Atrium Health, Charlotte, NC.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'West', 'Affiliation': 'Swedish Cancer Institute, Seattle, WA.'}, {'ForeName': 'Ray', 'Initials': 'R', 'LastName': 'Page', 'Affiliation': 'The Center for Cancer and Blood Disorders, Fort Worth, TX.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Reinmuth', 'Affiliation': 'Asklepios Fachkliniken München-Gauting, Gauting, Germany.'}, {'ForeName': 'Jeanna', 'Initials': 'J', 'LastName': 'Knoble', 'Affiliation': 'The Mark H. Zangmeister Center, Columbus, OH.'}, {'ForeName': 'Tianlei', 'Initials': 'T', 'LastName': 'Chen', 'Affiliation': 'Bristol Myers Squibb, Summit, NJ.'}, {'ForeName': 'Rafia', 'Initials': 'R', 'LastName': 'Bhore', 'Affiliation': 'Bristol Myers Squibb, Summit, NJ.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Wolfsteiner', 'Affiliation': 'PRA Health Sciences, Lenexa, KS.'}, {'ForeName': 'Teng Jin', 'Initials': 'TJ', 'LastName': 'Ong', 'Affiliation': 'Bristol Myers Squibb, Summit, NJ.'}, {'ForeName': 'Cesare', 'Initials': 'C', 'LastName': 'Gridelli', 'Affiliation': 'S.G. Moscati Hospital, Avellino, Italy.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Thomas', 'Affiliation': 'Internistische Onkologie der Thoraxtumoren, Thoraxklinik im Universitätsklinikum Heidelberg, Translational Lung Research Center Heidelberg, Heidelberg, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical lung cancer,['10.1016/j.cllc.2020.09.007']
2264,33097422,Effect of continuous antibiotic prophylaxis in children with postoperative JJ stents: A prospective randomized study.,"OBJECTIVE


We aimed to investigate the effectiveness of continuous antibiotic prophylaxis (CAP) in patients with JJ stent and tried to identify the group that could specifically benefit from CAP by a prospective randomized study.
METHODS


A prospective, randomized, controlled, non-blind, non-placebo study was performed in a single center.A total of 105 patients who underwent surgery with JJ stent (PNL, URS, pyeloplasty, UNC) were randomized into two groups. 53 patients in Group A received CAP and 52 patients in Group B were controlled without CAP, during the presence of a JJ stent. Patients with external stents, nephrostomy tubes, indwelling long-term urethral catheters were excluded. History of preoperative use of CAP and lower urinary tract symptoms were noted. Trimethoprim/sulfamethoxazole (TMP/SMX) was used as the initial choice of antibiotic however if there was a history of antibiotic resistance in previous urinary cultures, Nitrofurantoin was administrated. Urinary cultures were obtained before surgery and before stent extraction. JJ stents were sent to culture. Symptomatic febrile urinary tract infections with positive urine cultures (10 5  CFU on a clean catch or 10 3 with urethral catheterization) were compared between groups.
DISCUSSION


Our study has some limitations; the study is the single-center, we did not follow-up of patients in terms of scar, there were low number of uncircumcised patients, multiple types of surgical procedures were performed. JJ stent is a frequently used instrument in children. Unfortunately, any study on antibiotics administration while using a JJ stent is not available in the current literature. We hope our research will contribute to the existing literature and cause a significant change in clinical practice.
RESULTS


The mean age among all patients was 4.8 ± 3.9 years. The mean length of time jj stents stayed inside was 16.34 ± 6.45 days in group A and 15.29 ± 7.71 days in group B. The incidence of febrile urinary tract infections with CAP was significantly reduced (3.8% vs. 19% (p 0.015)). Multivariate regression analysis revealed that a positive history for preop febrile urinary tract infections and/or LUTS has a significantly higher association with the incidence of febrile urinary tract infecitons.
CONCLUSIONS


CAP in the presence of JJ stents reduced the incidence of febrile urinary tract infections in a short period, especially in children with the previous history of febrile urinary tract infections and lower urinary tract symptoms.",2020,The incidence of febrile urinary tract infections with CAP was significantly reduced (3.8% vs. 19% (p 0.015)).,"['105 patients who underwent surgery with JJ stent (PNL, URS, pyeloplasty, UNC', 'children', 'Patients with', 'children with postoperative JJ stents', 'patients with JJ stent']","['continuous antibiotic prophylaxis', 'JJ stents', 'continuous antibiotic prophylaxis (CAP', 'CAP', 'placebo', 'external stents, nephrostomy tubes, indwelling long-term urethral catheters', 'JJ stent', 'Trimethoprim/sulfamethoxazole (TMP/SMX']","['urinary tract symptoms', 'mean length of time jj stents stayed inside', 'febrile urinary tract infections', 'incidence of febrile urinary tract infections with CAP', 'Symptomatic febrile urinary tract infections']","[{'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0441293', 'cui_str': 'JJ-stent'}, {'cui': 'C0554139', 'cui_str': 'Pyeloplasty'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0282638', 'cui_str': 'Antibiotic prophylaxis'}, {'cui': 'C0441293', 'cui_str': 'JJ-stent'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0184149', 'cui_str': 'Nephrostomy tube'}, {'cui': 'C0439848', 'cui_str': 'Indwelling'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0179800', 'cui_str': 'Urethral catheter'}, {'cui': 'C0041041', 'cui_str': 'Trimethoprim'}, {'cui': 'C0038689', 'cui_str': 'Sulfamethoxazole'}]","[{'cui': 'C1508753', 'cui_str': 'Urinary system structure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0441293', 'cui_str': 'JJ-stent'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C3875265', 'cui_str': 'Febrile urinary tract infection'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0282638', 'cui_str': 'Antibiotic prophylaxis'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}]",105.0,0.0387543,The incidence of febrile urinary tract infections with CAP was significantly reduced (3.8% vs. 19% (p 0.015)).,"[{'ForeName': 'Aykut', 'Initials': 'A', 'LastName': 'Akinci', 'Affiliation': ""Department of Pediatric Urology, Ankara University School of Medicine, Cebeci Children's Hospital, Ankara, Turkey. Electronic address: aykut-akinci@hotmail.com.""}, {'ForeName': 'Eralp', 'Initials': 'E', 'LastName': 'Kubilay', 'Affiliation': 'Department of Urology, Ankara University School of Medicine, Ankara, Turkey.'}, {'ForeName': 'Vahid Talha', 'Initials': 'VT', 'LastName': 'Solak', 'Affiliation': 'Department of Urology, Ankara University School of Medicine, Ankara, Turkey.'}, {'ForeName': 'Murat Can', 'Initials': 'MC', 'LastName': 'Karaburun', 'Affiliation': 'Department of Urology, Ankara University School of Medicine, Ankara, Turkey.'}, {'ForeName': 'Can Utku', 'Initials': 'CU', 'LastName': 'Baklaci', 'Affiliation': 'Department of Urology, Ankara University School of Medicine, Ankara, Turkey.'}, {'ForeName': 'Ezel', 'Initials': 'E', 'LastName': 'Aydoğ', 'Affiliation': 'Department of Urology, Ankara University School of Medicine, Ankara, Turkey.'}, {'ForeName': 'Yakup Tarkan', 'Initials': 'YT', 'LastName': 'Soygür', 'Affiliation': ""Department of Pediatric Urology, Ankara University School of Medicine, Cebeci Children's Hospital, Ankara, Turkey.""}, {'ForeName': 'Berk', 'Initials': 'B', 'LastName': 'Burgu', 'Affiliation': ""Department of Pediatric Urology, Ankara University School of Medicine, Cebeci Children's Hospital, Ankara, Turkey.""}]",Journal of pediatric urology,['10.1016/j.jpurol.2020.10.004']
2265,33097481,Effect of an early mobilisation programme on pain intensity after laparoscopic surgery: a randomised clinical trial.,"BACKGROUND


Pain is a common complication after laparoscopic surgery. This study aimed to examine the effect of an early mobilisation programme on postoperative pain intensity after laparoscopic surgery.
METHODS


A randomised controlled clinical trial was conducted on 80 patients who underwent laparoscopic surgery in Shahid Beheshti Hospital in Kashan, Iran. The patients were randomly allocated to intervention (n=40) and a control (n=40) group. In the intervention group, an early mobilisation programme was implemented in two rounds. The patient's perceived pain was assessed using a Visual Analogue Scale 15 min before and 30 min after each round of early mobilisation. Data were analysed through the independent samples t, χ 2  and Fisher's exact tests and the repeated measures analysis.
RESULTS


The repeated measures analysis showed that the mean pain scores have been decreased over time (F=98.88, p<0.001). Considering the observed interaction between time and the intervention, the t test was used for pairwise comparisons and showed that the mean pain score was not significantly different between the two groups in 15 min before the first round of early mobilisation (p=0.95). However, the mean pain in the intervention group was significantly less than the control group in all subsequent measurements (p<0.05).
CONCLUSION


Early mobilisation programmes such as the one implemented in the current study are easy and inexpensive and can be implemented safely for the reduction of pain after laparoscopic surgeries.",2020,Early mobilisation programmes such as the one implemented in the current study are easy and inexpensive and can be implemented safely for the reduction of pain after laparoscopic surgeries.,"['80 patients who underwent laparoscopic surgery in Shahid Beheshti Hospital in Kashan, Iran', 'after laparoscopic surgery']",['early mobilisation programme'],"['postoperative pain intensity', 'mean pain scores', 'mean pain score', 'mean pain', 'pain intensity', 'pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",80.0,0.181683,Early mobilisation programmes such as the one implemented in the current study are easy and inexpensive and can be implemented safely for the reduction of pain after laparoscopic surgeries.,"[{'ForeName': 'Azam', 'Initials': 'A', 'LastName': 'Dehghani', 'Affiliation': 'Medical Surgical Nursing, Kashan University of Medical Sciences, Kashan, Iran (the Islamic Republic of).'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Hajibagheri', 'Affiliation': 'Medical Surgical Nursing, Kashan University of Medical Sciences, Kashan, Iran (the Islamic Republic of).'}, {'ForeName': 'Ismail', 'Initials': 'I', 'LastName': 'Azizi-Fini', 'Affiliation': 'Medical Surgical Nursing, Kashan University of Medical Sciences, Kashan, Iran (the Islamic Republic of) azizifinies@yahoo.com.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Atoof', 'Affiliation': 'Biostatistics, Kashan University of Medical Sciences, Kashan, Iran (the Islamic Republic of).'}, {'ForeName': 'Noushin', 'Initials': 'N', 'LastName': 'Mousavi', 'Affiliation': 'Surgery Department, Kashan University of Medical Sciences, Kashan, Iran (the Islamic Republic of).'}]",BMJ supportive & palliative care,['10.1136/bmjspcare-2020-002618']
2266,33097567,ICON 9-an international phase III randomized study to evaluate the efficacy of maintenance therapy with olaparib and cediranib or olaparib alone in patients with relapsed platinum-sensitive ovarian cancer following a response to platinum-based chemotherapy.,"BACKGROUND


Two novel biological agents-cediranib targeting angiogenesis, and olaparib targeting DNA repair processes-have individually led to an improvement in ovarian cancer control. The aim of ICON9 is to investigate the combination of cediranib and olaparib maintenance in recurrent ovarian cancer following platinum-based therapy.
PRIMARY OBJECTIVE


To assess the efficacy of maintenance treatment with olaparib in combination with cediranib compared with olaparib alone following a response to platinum-based chemotherapy in women with platinum-sensitive ovarian, fallopian tube or peritoneal cancer during first relapse.
STUDY HYPOTHESIS


Maintenance therapy with cediranib and olaparib in combination is associated with improved patient outcomes compared with olaparib alone.
TRIAL DESIGN


International phase III randomized controlled trial. Following a response to platinum-based chemotherapy patients are randomized 1:1 to either oral olaparib and cediranib (intervention arm) or oral olaparib alone (control arm).
MAJOR INCLUSION CRITERIA


Patients with a known diagnosis of high grade serous or endometrioid carcinoma of the ovary, fallopian tube or peritoneum, progressing more than 6 months after first-line platinum-based chemotherapy, who have responded to second-line platinum-based chemotherapy.
PRIMARY ENDPOINTS


Progression-free and overall survival. Co-primary endpoints to be assessed using a fixed-sequence gatekeeping approach: (1) progression-free survival, all patients; (2) progression-free survival, BRCA wild type; (3) overall survival, all patients; (4) overall survival, BRCA wild type.
SAMPLE SIZE


618 patients will be recruited.
ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS


Accrual is expected to be completed in 2024 with presentation of results in 2025.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT03278717.",2020,"PRIMARY ENDPOINTS


Progression-free and overall survival.","['patients with relapsed platinum-sensitive ovarian cancer following a response to platinum-based chemotherapy', 'Patients with a known diagnosis of high grade serous or endometrioid carcinoma of the ovary, fallopian tube or peritoneum, progressing more than 6 months after first-line platinum-based chemotherapy, who have responded to second-line platinum-based chemotherapy', '618 patients will be recruited', 'recurrent ovarian cancer following platinum-based therapy', 'women with platinum-sensitive ovarian, fallopian tube or peritoneal cancer during first relapse']","['olaparib and cediranib or olaparib alone', 'cediranib and olaparib maintenance', 'cediranib', 'oral olaparib and cediranib (intervention arm) or oral olaparib alone (control arm', 'cediranib and olaparib', 'olaparib alone', 'ICON9', 'platinum-based chemotherapy']","['Progression-free and overall survival', 'fixed-sequence gatekeeping approach: (1) progression-free survival, all patients; (2) progression-free survival, BRCA wild type; (3) overall survival, all patients; (4) overall survival, BRCA wild type']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0440743', 'cui_str': 'Serous'}, {'cui': 'C0346163', 'cui_str': 'Endometrioid carcinoma ovary'}, {'cui': 'C0015560', 'cui_str': 'Fallopian tube structure'}, {'cui': 'C0031153', 'cui_str': 'Peritoneum (serous membrane) structure'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0278689', 'cui_str': 'Recurrent ovarian cancer'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0153467', 'cui_str': 'Malignant tumor of peritoneum'}]","[{'cui': 'C2316164', 'cui_str': 'olaparib'}, {'cui': 'C1698364', 'cui_str': 'cediranib'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}]","[{'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0445392', 'cui_str': 'Wild'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]",618.0,0.223885,"PRIMARY ENDPOINTS


Progression-free and overall survival.","[{'ForeName': 'Osnat', 'Initials': 'O', 'LastName': 'Elyashiv', 'Affiliation': 'University College CRUK and UCL Cancer Trials Centre, UCL Cancer Institute, London, UK osnatelyashiv@gmail.com.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Ledermann', 'Affiliation': 'University College CRUK and UCL Cancer Trials Centre, UCL Cancer Institute, London, UK.'}, {'ForeName': 'Gita', 'Initials': 'G', 'LastName': 'Parmar', 'Affiliation': 'University College CRUK and UCL Cancer Trials Centre, UCL Cancer Institute, London, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Farrelly', 'Affiliation': 'University College CRUK and UCL Cancer Trials Centre, UCL Cancer Institute, London, UK.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Counsell', 'Affiliation': 'University College CRUK and UCL Cancer Trials Centre, UCL Cancer Institute, London, UK.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Feeney', 'Affiliation': 'University College CRUK and UCL Cancer Trials Centre, UCL Cancer Institute, London, UK.'}, {'ForeName': 'Fatima', 'Initials': 'F', 'LastName': 'El-Khouly', 'Affiliation': 'Barking Havering and Redbridge University Hospitals NHS Trust, Romford, UK.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Macdonald', 'Affiliation': 'University College CRUK and UCL Cancer Trials Centre, UCL Cancer Institute, London, UK.'}, {'ForeName': 'Andreia', 'Initials': 'A', 'LastName': 'Neto', 'Affiliation': 'University College CRUK and UCL Cancer Trials Centre, UCL Cancer Institute, London, UK.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Arthur-Darkwa', 'Affiliation': 'University College CRUK and UCL Cancer Trials Centre, UCL Cancer Institute, London, UK.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Burnett', 'Affiliation': 'University College CRUK and UCL Cancer Trials Centre, UCL Cancer Institute, London, UK.'}, {'ForeName': 'Gordon C', 'Initials': 'GC', 'LastName': 'Jayson', 'Affiliation': 'Medical Oncology, The Christie NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Mileshkin', 'Affiliation': 'Department of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.'}, {'ForeName': 'Charlie', 'Initials': 'C', 'LastName': 'Gourley', 'Affiliation': 'Nicola Murray Centre for Ovarian Cancer Research, CRUK Edinburgh Centre, MRC IGMM, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Shibani', 'Initials': 'S', 'LastName': 'Nicum', 'Affiliation': 'Oxford University Hospitals NHS Trust, Oxford, UK.'}]",International journal of gynecological cancer : official journal of the International Gynecological Cancer Society,['10.1136/ijgc-2020-002073']
2267,33097954,"An Expression of Concern from The Journal of Nutrition's Editorial Office about: Vitamin D Supplementation Affects the Beck Depression Inventory, Insulin Resistance, and Biomarkers of Oxidative Stress in Patients with Major Depressive Disorder: A Randomized, Controlled Clinical Trial.",,2020,,['Patients with Major Depressive Disorder'],['Vitamin D Supplementation'],"['Beck Depression Inventory, Insulin Resistance, and Biomarkers of Oxidative Stress']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}]","[{'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}]",,0.232398,,"[{'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Sepehrmanesh', 'Affiliation': ''}, {'ForeName': 'Fariba', 'Initials': 'F', 'LastName': 'Kolahdooz', 'Affiliation': ''}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Abedi', 'Affiliation': ''}, {'ForeName': 'Navid', 'Initials': 'N', 'LastName': 'Mazroii', 'Affiliation': ''}, {'ForeName': 'Amin', 'Initials': 'A', 'LastName': 'Assarian', 'Affiliation': ''}, {'ForeName': 'Zatollah', 'Initials': 'Z', 'LastName': 'Asemi', 'Affiliation': ''}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Esmaillzadeh', 'Affiliation': ''}]",The Journal of nutrition,['10.1093/jn/nxaa341']
2268,33097977,Effects of ibuprofen and low-level laser therapy on orthodontic pain by means of the analysis of interleukin 1-beta and substance P levels in the gingival crevicular fluid.,"OBJECTIVE


The goal of this study was to compare the effects of ibuprofen and low-level laser therapy in alleviating orthodontic pain observed after elastomeric separator placement (ESP) by means of the analysis of interleukin 1‑beta (IL-1β) and substance P (SP) levels in gingival crevicular fluid (GCF) and visual analog scale (VAS).
MATERIALS AND METHODS


A total of 60 subjects requiring ESP for the banding of maxillary first molars were randomly assigned to the ibuprofen, laser, and control groups. The ibuprofen and control groups received, respectively, 400 mg ibuprofen and placebo lactose tablets orally 1 h before ESP; the laser group received a single low-level laser irradiation session immediately after ESP. GCF samples were collected immediately after ESP (day 0) and on days 1, 3, and 7. Pain intensity was evaluated using the VAS immediately after ESP (baseline) and at hours 2 and 6, as well as on days 1, 3, and 7.
RESULTS


Although IL-1β levels increased significantly on days 1, 3, and 7 compared to day 0, intergroup comparison results revealed insignificant differences. SP levels indicated insignificant within-group differences. Only the SP levels of the ibuprofen group showed a significant decrease on days 0 and 1 compared to the laser and control groups. In all groups, VAS scores increased from baseline to a peak level on day 1, followed by a significant decrease on days 3 and 7. Intergroup comparison results of VAS scores indicated less pain intensity in the ibuprofen group compared to the control group at baseline.
CONCLUSIONS


Only the ibuprofen group exhibited significant decreases in SP levels on days 0 and 1, as well as in VAS scores at baseline.",2020,"Intergroup comparison results of VAS scores indicated less pain intensity in the ibuprofen group compared to the control group at baseline.
",['60\xa0subjects requiring ESP for the banding of maxillary first molars'],"['ibuprofen, laser, and control groups', 'ibuprofen and low-level laser therapy', 'elastomeric separator placement (ESP', 'ibuprofen', 'ibuprofen and placebo lactose tablets']","['orthodontic pain', 'VAS scores', 'IL-1β levels', 'interleukin 1‑beta (IL-1β) and substance P (SP) levels in gingival crevicular fluid (GCF) and visual analog scale (VAS', 'pain intensity', 'Pain intensity', 'SP levels']","[{'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0227056', 'cui_str': 'Structure of mandibular left first molar tooth'}]","[{'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0022949', 'cui_str': 'Lactose'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0038585', 'cui_str': 'Substance P'}, {'cui': 'C0017564', 'cui_str': 'Gingival Exudate'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",,0.0600737,"Intergroup comparison results of VAS scores indicated less pain intensity in the ibuprofen group compared to the control group at baseline.
","[{'ForeName': 'Yeşim', 'Initials': 'Y', 'LastName': 'Kaya', 'Affiliation': 'Department of Orthodontics, Faculty of Dentistry, Van Yüzüncü Yıl University, Van, Turkey. yesimkaya82@hotmail.com.'}, {'ForeName': 'Özer', 'Initials': 'Ö', 'LastName': 'Alkan', 'Affiliation': 'Department of Orthodontics, Faculty of Dentistry, Yıldırım Beyazıt University, Ankara, Turkey.'}, {'ForeName': 'Ahmet Ufuk', 'Initials': 'AU', 'LastName': 'Kömüroglu', 'Affiliation': 'Health Service Vocational School of Higher Education, Van, Turkey.'}, {'ForeName': 'Sıddık', 'Initials': 'S', 'LastName': 'Keskin', 'Affiliation': 'Department of Biostatistics, Faculty of Medicine, Van Yüzüncü Yıl University, Van, Turkey.'}]",Journal of orofacial orthopedics = Fortschritte der Kieferorthopadie : Organ/official journal Deutsche Gesellschaft fur Kieferorthopadie,['10.1007/s00056-020-00254-2']
2269,33098041,Busulfan-cyclophosphamide versus cyclophosphamide-busulfan as conditioning regimen before allogeneic hematopoietic cell transplantation: a prospective randomized trial.,"Busulfan and cyclophosphamide (BuCy) is a frequently used myeloablative conditioning regimen for allogeneic hematopoietic cell transplantation (allo-HCT). Theoretical considerations and pharmacological data indicate that application of busulfan prior to subsequent cyclophosphamide (BuCy) may trigger liver toxicity. Reversing the order of application to cyclophosphamide-busulfan (CyBu) might be preferable, a hypothesis supported by animal data and retrospective studies. We performed a prospective randomized trial to determine impact of order of application of Bu and Cy before allo-HCT in 70 patients with hematological malignancy, 33 patients received BuCy and 37 CyBu for conditioning. In the short term, there were minimal differences in liver toxicity favoring CyBu over BuCy, significant only for alanine amino transferase at day 30 (p = 0.03). With longer follow-up at 4 years, non-relapse mortality (6% versus 27%, p = 0.05) was lower and survival (63% versus 43%, p = 0.06) was higher with CyBu compared to BuCy. Other outcomes, such as engraftment (p = 0.21), acute and chronic graft-versus-host disease (p = 0.40; 0.36), and relapse (p = 0.79), were similar in both groups. We prospectively show evidence that the order of application of Cy and Bu in myeloablative conditioning in allo-HCT patients has impact on outcome.",2020,"With longer follow-up at 4 years, non-relapse mortality (6% versus 27%, p = 0.05) was lower and survival (63% versus 43%, p = 0.06) was higher with CyBu compared to BuCy.","['70 patients with hematological malignancy, 33 patients received BuCy and 37 CyBu for conditioning', 'allogeneic hematopoietic cell transplantation']","['Busulfan-cyclophosphamide versus cyclophosphamide-busulfan', 'Busulfan and cyclophosphamide (BuCy', 'cyclophosphamide-busulfan (CyBu', 'Bu and Cy before allo-HCT', 'cyclophosphamide (BuCy']","['liver toxicity favoring CyBu over BuCy', 'relapse', 'alanine amino transferase', 'non-relapse mortality', 'survival', 'acute and chronic graft-versus-host disease']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376545', 'cui_str': 'Hematologic neoplasm'}, {'cui': 'C0006463', 'cui_str': 'Busulfan'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}]","[{'cui': 'C0006463', 'cui_str': 'Busulfan'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}]","[{'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0006463', 'cui_str': 'Busulfan'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0057041', 'cui_str': 'D-amino-acid transaminase'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0867389', 'cui_str': 'Chronic graft-versus-host disease'}]",70.0,0.0214166,"With longer follow-up at 4 years, non-relapse mortality (6% versus 27%, p = 0.05) was lower and survival (63% versus 43%, p = 0.06) was higher with CyBu compared to BuCy.","[{'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Seydoux', 'Affiliation': 'Divisions of Hematology and Internal Medicine, Department of Medicine, University Hospital of Basel, Petersgraben 4, CH-4031, Basel, Switzerland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Medinger', 'Affiliation': 'Divisions of Hematology and Internal Medicine, Department of Medicine, University Hospital of Basel, Petersgraben 4, CH-4031, Basel, Switzerland. michael.medinger@usb.ch.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Gerull', 'Affiliation': 'Divisions of Hematology and Internal Medicine, Department of Medicine, University Hospital of Basel, Petersgraben 4, CH-4031, Basel, Switzerland.'}, {'ForeName': 'Joerg', 'Initials': 'J', 'LastName': 'Halter', 'Affiliation': 'Divisions of Hematology and Internal Medicine, Department of Medicine, University Hospital of Basel, Petersgraben 4, CH-4031, Basel, Switzerland.'}, {'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Heim', 'Affiliation': 'Divisions of Hematology and Internal Medicine, Department of Medicine, University Hospital of Basel, Petersgraben 4, CH-4031, Basel, Switzerland.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Chalandon', 'Affiliation': 'Division of Hematology, Bone Marrow Transplant Unit, University Hospital of Geneva and Faculty of Medicine, University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Stavroula Masouridi', 'Initials': 'SM', 'LastName': 'Levrat', 'Affiliation': 'Division of Hematology, Bone Marrow Transplant Unit, University Hospital of Geneva and Faculty of Medicine, University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Urs', 'Initials': 'U', 'LastName': 'Schanz', 'Affiliation': 'Department of Medical Oncology and Hematology, Stem-/Immune- cell-transplant Unit, University Hospital of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Gayathri', 'Initials': 'G', 'LastName': 'Nair', 'Affiliation': 'Department of Medical Oncology and Hematology, Stem-/Immune- cell-transplant Unit, University Hospital of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Ansari', 'Affiliation': 'Department Women, Children and Adolescent, Unit of Oncology and Hematology Pediatric, University Hospital of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Simon', 'Affiliation': 'Clinical Trials Unit, Department of Clinical Research, Basel University, Basel, Switzerland.'}, {'ForeName': 'Jakob R', 'Initials': 'JR', 'LastName': 'Passweg', 'Affiliation': 'Divisions of Hematology and Internal Medicine, Department of Medicine, University Hospital of Basel, Petersgraben 4, CH-4031, Basel, Switzerland. jakob.passweg@usb.ch.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Cantoni', 'Affiliation': 'Division of Oncology, Hematology and Transfusion Medicine, Kantonsspital Aarau, Aarau, Switzerland.'}]",Annals of hematology,['10.1007/s00277-020-04312-y']
2270,33098114,Impact of group antenatal care on key antenatal services and educational topics in Malawi and Tanzania.,"OBJECTIVE


To examine whether group antenatal care (ANC) increased key services and educational topics women reported receiving, compared to individual ANC in Malawi and Tanzania.
METHODS


Data come from a previously published randomized trial (n = 218) and were collected using self-report surveys. Late pregnancy surveys asked whether women received all seven services and all 13 topics during ANC. Controlling for sociodemographic, country, and ANC attendance, multivariate logistic regression used forward selection to produce a final model showing predictors of receipt of all key services and topics.
RESULTS


In multivariate logistic regression, women in group ANC were 2.49 times more likely to receive all 7 services than those in individual care (95% CI, 1.78 - 3.48) and 5.25 times more likely to have received all 13 topics (95% CI = 2.62, 10.52).
CONCLUSION


This study provides strong evidence that Group ANC meets the clinical standard of care for providing basic clinical services and perinatal education for pregnant women in SSA. The greater number of basic ANC services and educational topics may provide one explanatory mechanism for how group ANC achieves its impact on maternal and neonatal outcomes.",2020,"In multivariate logistic regression, women in group ANC were 2.49 times more likely to receive all 7 services than those in individual care (95% CI, 1.78 - 3.48) and 5.25 times more likely to have received all 13 topics (95% CI = 2.62, 10.52).
","['pregnant women in SSA', 'Data come from a previously published randomized trial (n = 218) and were collected using self-report surveys']",[],[],"[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C2732618', 'cui_str': 'Sessile serrated adenoma'}, {'cui': 'C0960273', 'cui_str': 'CAME'}, {'cui': 'C0034037', 'cui_str': 'Publishing'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4517647', 'cui_str': '218'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]",[],[],218.0,0.0577475,"In multivariate logistic regression, women in group ANC were 2.49 times more likely to receive all 7 services than those in individual care (95% CI, 1.78 - 3.48) and 5.25 times more likely to have received all 13 topics (95% CI = 2.62, 10.52).
","[{'ForeName': 'Kylea L', 'Initials': 'KL', 'LastName': 'Liese', 'Affiliation': 'University of Illinois at Chicago, College of Nursing, Department of Human Development Nursing Science, 845 S. Damen Avenue (M/C 806), Chicago, IL, 60612, USA.'}, {'ForeName': 'Esnath', 'Initials': 'E', 'LastName': 'Kapito', 'Affiliation': 'University of Malawi, Kamuzu College of Nursing, PO Box 415, Blantyre, Malawi.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Chirwa', 'Affiliation': 'University of Malawi, Kamuzu College of Nursing, PO Box 415, Blantyre, Malawi.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'University of Illinois at Chicago, School of Public Health, 1603 W. Taylor Street (M/C 932), Chicago, IL, 60612, USA.'}, {'ForeName': 'Xiaohan', 'Initials': 'X', 'LastName': 'Mei', 'Affiliation': 'University of Illinois at Chicago, School of Public Health, 1603 W. Taylor Street (M/C 932), Chicago, IL, 60612, USA.'}, {'ForeName': 'Kathleen F', 'Initials': 'KF', 'LastName': 'Norr', 'Affiliation': 'University of Illinois at Chicago, College of Nursing, Department of Human Development Nursing Science, 845 S. Damen Avenue (M/C 806), Chicago, IL, 60612, USA.'}, {'ForeName': 'Crystal L', 'Initials': 'CL', 'LastName': 'Patil', 'Affiliation': 'University of Illinois at Chicago, College of Nursing, Department of Human Development Nursing Science, 845 S. Damen Avenue (M/C 806), Chicago, IL, 60612, USA.'}]",International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics,['10.1002/ijgo.13432']
2271,33098117,Efficacy and safety of breast milk eye drops in infants with eye discharge.,"AIM


Breast milk（BM） contains various protective components, such as immunoglobulins, lactoferrin, lysozyme, oligosaccharides, and immune cell subsets. We evaluated the effectiveness of BM eye drops in infants with eye discharge in a randomised controlled study.
METHODS


Subjects were breastfed infants aged ≤ 180 days, with eye discharge. We randomly assigned patients to receive eye drops of BM or sodium azulene sulfonate hydrate 0.02% ophthalmic solution (OS). The patients received drop of BM or OS for 7 days. Improvement score of eye discharge in the groups was compared using a non-inferiority test.
RESULTS


The number of patients improved eye discharge was 119/155 (76.8%) and 119/157 (75.8%) in BM and OS groups, respectively. There were no significant differences between groups. The improvement score in eye discharge was 1.76±0.91 in the BM group and 1.71±0.96 in the OS group. The BM group was considered non-inferior to the OS group.
CONCLUSIONS


This study demonstrated that BM is no less effective than OS in infants with eye discharge aged ≤ 6 months. The results suggested that the use of breast milk as eye drops could be considered as a first-line treatment for infants aged ≤ 6 months with eye discharge.",2020,The improvement score in eye discharge was 1.76±0.91 in the BM group and 1.71±0.96 in the OS group.,"['infants aged ≤ 6 months with eye discharge', 'Subjects were breastfed infants aged ≤ 180 days, with eye discharge', 'infants with eye discharge', 'infants with eye discharge aged ≤ 6 months', 'infants with eye discharge in a randomised controlled study']","['BM or sodium azulene sulfonate hydrate 0.02% ophthalmic solution (OS', 'breast milk eye drops', 'BM eye drops']","['Improvement score of eye discharge', 'Efficacy and safety', 'number of patients improved eye discharge', 'improvement score in eye discharge']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0423006', 'cui_str': 'Discharge from eye'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0052822', 'cui_str': 'Azulene'}, {'cui': 'C0002072', 'cui_str': 'Alkyl Sulfonates'}, {'cui': 'C4517398', 'cui_str': '0.02'}, {'cui': 'C0015399', 'cui_str': 'Eye drops'}, {'cui': 'C0026131', 'cui_str': 'Milk'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0423006', 'cui_str': 'Discharge from eye'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",,0.104396,The improvement score in eye discharge was 1.76±0.91 in the BM group and 1.71±0.96 in the OS group.,"[{'ForeName': 'Tetsu', 'Initials': 'T', 'LastName': 'Sugimura', 'Affiliation': ""Department of Pediatrics and Allergology, Sugimura Children's Medical Clinic, Chikugo City, Fukuoka, Japan.""}, {'ForeName': 'Tomoko', 'Initials': 'T', 'LastName': 'Seo', 'Affiliation': ""Department of Pediatrics, Green Woods Children's Clinic, Okazaki City, Aichi, Japan.""}, {'ForeName': 'Nami', 'Initials': 'N', 'LastName': 'Terasaki', 'Affiliation': ""Department of Pediatrics and Allergology, Sugimura Children's Medical Clinic, Chikugo City, Fukuoka, Japan.""}, {'ForeName': 'Yukiko', 'Initials': 'Y', 'LastName': 'Ozaki', 'Affiliation': 'Department of Pediatrics, Kurume University School of Medicine, Kurume City, Fukuoka, Japan.'}, {'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Rikitake', 'Affiliation': ""Department of Pediatrics and Allergology, Sugimura Children's Medical Clinic, Chikugo City, Fukuoka, Japan.""}, {'ForeName': 'Rumiko', 'Initials': 'R', 'LastName': 'Okabe', 'Affiliation': 'Department of Pediatrics, Kurume University School of Medicine, Kurume City, Fukuoka, Japan.'}, {'ForeName': 'Masami', 'Initials': 'M', 'LastName': 'Matsushita', 'Affiliation': 'Department of Pediatrics, Kurume University School of Medicine, Kurume City, Fukuoka, Japan.'}]","Acta paediatrica (Oslo, Norway : 1992)",['10.1111/apa.15628']
2272,33097945,Effect of exercise intensity on exogenous glucose requirements to maintain stable glycemia at high insulin levels in type 1 diabetes.,"CONTEXT


Under basal insulin levels, there is an inverted U relationship between exercise intensity and exogenous glucose requirements to maintain stable blood glucose levels in type 1 diabetes (T1D), with no glucose required for intense exercise (80% V̇O2 peak), implying that high intensity exercise is not conducive to hypoglycemia.
OBJECTIVE


To test the hypothesis that a similar inverted U relationship exists under hyperinsulinemic conditions, with high intensity aerobic exercise not being conducive to hypoglycemia.
METHODS


Nine young adults with T1D (mean±SD age, 22.6±4.7y; glycated hemoglobin, 61±14mmol·mol -1; body mass index, 24.0±3.3kg·m -2, V̇O2 peak, 36.6±8.0ml·kg -1min -1) were subjected to a hyperinsulinemic-euglycemic clamp to maintain stable glycemia (5-6mmol·L -1), and exercised for 40 min at 4 different intensities (35, 50, 65 and 80% V̇O2peak) on separate days following a randomized counterbalanced study design.
MAIN OUTCOME MEASURES


Glucose infusion rates (GIR) and glucoregulatory hormones levels.
RESULTS


The GIR (±SEM) to maintain euglycemia was 4.4±0.4mg·kg -1min -1 prior to exercise, and increased significantly by 1.8±0.4, 3.0±0.4, 4.2±0.7, and 3.5±0.7mg·kg -1min -1 during exercise at 35, 50, 65, and 80% V̇O2 peak, respectively, with no significant differences between the two highest exercise intensities (p>0.05), despite differences in catecholamine levels (p<0.05). During the 2-h period after exercise at 65 and 80% V̇O2 peak, GIRs did not differ from those during exercise (p>0.05).
CONCLUSIONS


Under hyperinsulinemic conditions, the exogenous glucose requirements to maintain stable glycemia during and after exercise increase with exercise intensity then plateau with exercise performed at above moderate intensity (> 65% V̇O2 peak). High intensity exercise confers no protection against hypoglycemia.",2020,"prior to exercise, and increased significantly by 1.8±0.4, 3.0±0.4, 4.2±0.7, and 3.5±0.7mg·kg","['Nine young adults with T1D (mean±SD age, 22.6±4.7y; glycated hemoglobin, 61±14mmol·mol -1; body mass index, 24.0±3.3kg·m -2, V̇O2 peak, 36.6±8.0ml·kg -1min -1', 'type 1 diabetes']","['intensity aerobic exercise', 'hyperinsulinemic-euglycemic clamp to maintain stable glycemia (5-6mmol·L -1), and exercised for 40\xa0min at 4 different intensities', 'High intensity exercise', 'exercise intensity']","['Glucose infusion rates (GIR) and glucoregulatory hormones levels', 'catecholamine levels']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}]","[{'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0079318', 'cui_str': 'Euglycaemic Clamp'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}]","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C1287355', 'cui_str': 'Hormone level - finding'}, {'cui': 'C0428369', 'cui_str': 'Catecholamine level - finding'}]",9.0,0.0621144,"prior to exercise, and increased significantly by 1.8±0.4, 3.0±0.4, 4.2±0.7, and 3.5±0.7mg·kg","[{'ForeName': 'Vinutha B', 'Initials': 'VB', 'LastName': 'Shetty', 'Affiliation': 'Department of Endocrinology and Diabetes, Perth Children Hospital, Perth, W.A., Australia.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Fournier', 'Affiliation': 'School of Human Sciences, The University of Western Australia, Perth, W.A., Australia.'}, {'ForeName': 'Nirubasini', 'Initials': 'N', 'LastName': 'Paramalingam', 'Affiliation': 'Department of Endocrinology and Diabetes, Perth Children Hospital, Perth, W.A., Australia.'}, {'ForeName': 'Wayne', 'Initials': 'W', 'LastName': 'Soon', 'Affiliation': ""Children's Diabetes Centre, Telethon Kids Institute, The University of Western Australia, Perth, W.A., Australia.""}, {'ForeName': 'Heather C', 'Initials': 'HC', 'LastName': 'Roby', 'Affiliation': ""Children's Diabetes Centre, Telethon Kids Institute, The University of Western Australia, Perth, W.A., Australia.""}, {'ForeName': 'Timothy W', 'Initials': 'TW', 'LastName': 'Jones', 'Affiliation': 'Department of Endocrinology and Diabetes, Perth Children Hospital, Perth, W.A., Australia.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Davis', 'Affiliation': 'Department of Endocrinology and Diabetes, Perth Children Hospital, Perth, W.A., Australia.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa768']
2273,33097947,Evaluation of Cognitive Performance following Fish-Oil and Curcumin Supplementation in Middle-Aged and Older Adults with Overweight or Obesity.,"BACKGROUND


Obesity accelerates age-related cognitive decline, which is partly mediated by vascular dysfunction.
OBJECTIVE


The aim was to test the hypothesis that supplementation with fish oil and curcumin can enhance cognitive performance by improving cerebral circulatory function in overweight or obese middle-aged to older adults.
METHODS


In a 16-wk double-blind, placebo-controlled intervention trial, adults [50-80 y; BMI (kg/m2): 25-40] were randomly assigned to either fish oil (2000 mg/d DHA + 400 mg/d EPA), curcumin (160 mg/d), or a combination. Effects on cerebrovascular function (primary outcome) and cardiovascular risk factors were reported previously. Effects on cognitive performance and cerebrovascular responsiveness (CVR) to cognitive stimuli are reported herein. One-factor ANOVA with post hoc analyses was conducted between groups in the whole cohort and in males and females separately. Two-factor ANOVA was conducted to assess independent effects of fish oil and curcumin and a potential interaction. Correlations between outcomes (those obtained herein and previously reported) were also examined.
RESULTS


Compared with placebo, fish oil improved CVR to a processing speed test (4.4% ± 1.9% vs. -2.2% ± 2.1%; P = 0.023) and processing speed in males only (Z-score: 0.6 ± 0.2 vs. 0.1 ± 0.2; P = 0.043). Changes in processing speed correlated inversely with changes in blood pressure (R = -0.243, P = 0.006) and C-reactive protein (R = -0.183, P = 0.046). Curcumin improved CVR in a working memory test (3.6% ± 1.2% vs. -0.2% ± 0.2%, P = 0.026) and, in males only, performance of a verbal memory test compared with placebo (Z-score: 0.2 ± 0.1 vs. -0.5 ± 0.2, P = 0.039). Combining fish oil with curcumin did not produce additional benefits.
CONCLUSIONS


Improvements in processing speed following fish-oil supplementation in middle-aged to older males might be mediated by improvements in circulatory function. Mechanisms underlying the cognitive benefit seen with curcumin are unknown. As cognitive benefits were found in males only, further evaluation of sex differences in responsiveness to supplementation is warranted. This trial was registered at the Australian and New Zealand Clinical Trial Register at https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=370788 as ACTRN12616000732482p.",2020,"Compared with placebo, fish oil improved CVR to a processing speed test (4.4% ± 1.9% vs. -2.2% ± 2.1%; P = 0.023) and processing speed in males only (Z-score: 0.6 ± 0.2 vs. 0.1 ± 0.2; P = 0.043).","['overweight or obese middle-aged to older adults', ' 25-40', 'Middle-Aged and Older Adults with Overweight or Obesity', 'middle-aged to older males', 'adults [50-80 y; BMI (kg/m2']","['fish oil and curcumin', 'placebo', 'placebo, fish oil', 'processing speed following fish-oil supplementation', 'fish oil (2000 mg/d DHA\xa0+\xa0400 mg/d EPA), curcumin', 'Fish-Oil and Curcumin Supplementation']","['cardiovascular risk factors', 'C-reactive protein', 'cognitive performance', 'Curcumin improved CVR', 'blood pressure', 'cerebral circulatory function', 'processing speed', 'cognitive performance and cerebrovascular responsiveness (CVR', 'performance of a verbal memory test', 'cerebrovascular function', 'CVR to a processing speed test']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0026062', 'cui_str': 'Middle-age'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}]","[{'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0142831', 'cui_str': 'sodium dehydroacetate'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}]","[{'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0582591', 'cui_str': 'Processing speed'}]",,0.581939,"Compared with placebo, fish oil improved CVR to a processing speed test (4.4% ± 1.9% vs. -2.2% ± 2.1%; P = 0.023) and processing speed in males only (Z-score: 0.6 ± 0.2 vs. 0.1 ± 0.2; P = 0.043).","[{'ForeName': 'Julia C', 'Initials': 'JC', 'LastName': 'Kuszewski', 'Affiliation': 'Clinical Nutrition Research Centre, School of Biomedical Sciences and Pharmacy, University of Newcastle, Callaghan, Australia.'}, {'ForeName': 'Peter R C', 'Initials': 'PRC', 'LastName': 'Howe', 'Affiliation': 'Clinical Nutrition Research Centre, School of Biomedical Sciences and Pharmacy, University of Newcastle, Callaghan, Australia.'}, {'ForeName': 'Rachel H X', 'Initials': 'RHX', 'LastName': 'Wong', 'Affiliation': 'Clinical Nutrition Research Centre, School of Biomedical Sciences and Pharmacy, University of Newcastle, Callaghan, Australia.'}]",The Journal of nutrition,['10.1093/jn/nxaa299']
2274,33098159,Preventing Depression Among Older People Living in Rural Areas: a Randomised Controlled Trial of Behavioural Activation in Collaborative Care.,"OBJECTIVES


This study aimed to test if a behavioural activation (BA) program was more effective than usual care at reducing the risk of conversion to major depression over 52 weeks among adults aged 65 years or older living in rural Western Australia. Secondary aims were to test if participants assigned to the BA intervention experienced greater decline in the severity of depressive and anxiety symptoms than older adults treated with usual care over 26 and 52 weeks, as well as greater improvement in physical and mental health-related quality of life.
METHODS


Randomised controlled clinical trial that started recruitment in February 2016 in rural Western Australia. We used the electoral roll to invite adults aged 65 years or over living in suitable regions of Western Australia to take part in the study. We recruited those who consented and screened positive to at least one of the two Whooley questions: feeling down/depressed/hopeless or little interest or pleasure over the past month. Participants were randomly assigned to usual care or usual care plus a phone-delivered BA program (1:1). The intervention consisted of a self-managed BA program supported by three 45-minute phone sessions delivered by a BA therapist over a period of 8 weeks. We used the DSM-5 criteria to establish the presence of a major depressive episode, and PHQ-9, GAD-7 and SF-36 to assess symptoms of depression, anxiety and quality of life.
RESULTS


Of the 309 older adults randomised, 307 started the trial: 153 usual care and 154 BA (computer-generated random permuted even blocks ranging in size from 8 to 20). Six participants developed a major depressive episode during follow up, 4 of them in the usual care group (odds ratio of depression associated with the intervention = 0.49, 95%CI = 0.04, 3.49 - blind assessment). Seventy-three (23.8%) participants were lost over 52 weeks - there were no differences between usual care and intervention group. Intention-to-treat analyses using mixed regression models found modest non-significant effects of the BA intervention, while complete-case analyses showed that participants treated with BA compared with usual care experienced significant improvements in depression and anxiety symptoms over 52 weeks, as well as improved mental health quality of life.
CONCLUSIONS


Few participants developed a major depressive episode during follow up. The BA intervention was associated with improved symptoms of depression and anxiety, although the clinical significance of these benefits remains unclear. This article is protected by copyright. All rights reserved.",2020,Seventy-three (23.8%) participants were lost over 52 weeks - there were no differences between usual care and intervention group.,"['February 2016 in rural Western Australia', 'invite adults aged 65 years or over living in suitable regions of Western Australia to take part in the study', 'We recruited those who consented and screened positive to at least one of the two Whooley questions: feeling down/depressed/hopeless or little interest or pleasure over the past month', ' 307 started the trial: 153 usual care and 154 BA', '309 older adults randomised', 'adults aged 65 years or older living in rural Western Australia', 'Older People Living in Rural Areas']","['behavioural activation (BA) program', 'usual care or usual care plus a phone-delivered BA program', 'BA intervention', 'self-managed BA program supported by three 45-minute phone sessions delivered by a BA therapist']","['physical and mental health-related quality of life', 'mental health quality of life', 'major depressive episode', 'depression, anxiety and quality of life', 'severity of depressive and anxiety symptoms', 'symptoms of depression and anxiety', 'depression and anxiety symptoms']","[{'cui': 'C0043128', 'cui_str': 'Western Australia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0150041', 'cui_str': 'Feeling hopeless'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0205136', 'cui_str': 'Over'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C1442463', 'cui_str': 'Forty-five minutes'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0024517', 'cui_str': 'Major depression, single episode'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",,0.114435,Seventy-three (23.8%) participants were lost over 52 weeks - there were no differences between usual care and intervention group.,"[{'ForeName': 'Osvaldo P', 'Initials': 'OP', 'LastName': 'Almeida', 'Affiliation': 'WA Centre for Health and Ageing, Medical School, University of Western Australia, Perth, Australia.'}, {'ForeName': 'Hema', 'Initials': 'H', 'LastName': 'Patel', 'Affiliation': 'WA Centre for Health and Ageing, Medical School, University of Western Australia, Perth, Australia.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Kelly', 'Affiliation': 'WA Centre for Health and Ageing, Medical School, University of Western Australia, Perth, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Ford', 'Affiliation': 'WA Centre for Health and Ageing, Medical School, University of Western Australia, Perth, Australia.'}, {'ForeName': 'Leon', 'Initials': 'L', 'LastName': 'Flicker', 'Affiliation': 'WA Centre for Health and Ageing, Medical School, University of Western Australia, Perth, Australia.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Robinson', 'Affiliation': 'School of Public Health, Curtin University, Perth, Australia.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Araya', 'Affiliation': ""Centre for Global Mental Health, King's College London, UK.""}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Gilbody', 'Affiliation': 'Department of Health Sciences, University of York, UK.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Thompson', 'Affiliation': 'WA Centre for Rural Health, School of Population and Global Health, University of Western Australia, Perth, Australia.'}]",International journal of geriatric psychiatry,['10.1002/gps.5449']
2275,33098161,An Effective Hydroquinone Alternative for Topical Skin Lightening.,"BACKGROUND


Many skin lightening preparations containing hydroquinone, kojic acid, arbutin, and deoxyarbutin are toxic to melanocytes.
OBJECTIVE


This research examined a new skin lightening agent from a family of gem difluorocompounds 2-[2-(2,4-Difluorophenyl)-2-propen-1-yl]-1,3- propanediol that also function as tyrosinase inhibitors. This ingredient does not exhibit melanocyte toxicity yet is capable of inducing skin lightening. This research compared the gem difluorocompound, TFC-1067, to hydroquinone evaluating both tolerability and efficacy for lightening facial dyschromia.
METHOD


48 nonpregnant and non-nursing healthy female subjects age 25-70 years skin types I-IV with mild to moderate facial dyschromia were randomized to receive either study product or 2% hydroquinone cream. Subject and investigator tolerability and efficacy assessments were made at baseline, week 4, week 8, and week 12. Dermaspectrophotometer readings from normal skin and a pigmented target area were obtained. All subjects underwent facial photography at each visit.
RESULTS


TFC-1067 and 2% hydroquinone produced statistically significant skin lightening after 8 weeks of use, but only hydroquinone lightened the normal skin. This pattern continued into week 12 where both products significantly lightened dyschromic skin, but hydroquinone also lightened the normal skin, which is not always desirable.
SUMMARY


This research demonstrated the safety of TFC-1067 with efficacy parity to 2% hydroquinone that preferentially lightened dyschromia over surrounding normal pigmented skin.",2020,"RESULTS


TFC-1067 and 2% hydroquinone produced statistically significant skin lightening after 8 weeks of use, but only hydroquinone lightened the normal skin.","['I-IV with mild to moderate facial dyschromia', '48 nonpregnant and non-nursing healthy female subjects age 25-70 years skin types']","['hydroquinone', 'TFC-1067', 'hydroquinone cream']",[],"[{'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0151907', 'cui_str': 'Discoloration of skin'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0020306', 'cui_str': 'hydroquinone'}, {'cui': 'C1252137', 'cui_str': 'hydroquinone Topical Cream'}]",[],,0.0150092,"RESULTS


TFC-1067 and 2% hydroquinone produced statistically significant skin lightening after 8 weeks of use, but only hydroquinone lightened the normal skin.","[{'ForeName': 'Zoe Diana', 'Initials': 'ZD', 'LastName': 'Draelos', 'Affiliation': 'Dermatology Consulting Services, PLLC, High Point, NC, USA.'}, {'ForeName': 'Geraldine', 'Initials': 'G', 'LastName': 'Deliencourt-Godefroy', 'Affiliation': 'TFChem, Val de Reuil, France.'}, {'ForeName': 'Lénaïg', 'Initials': 'L', 'LastName': 'Lopes', 'Affiliation': 'TFChem, Val de Reuil, France.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13771']
2276,33098169,Comparison of the short-term efficacy and serum markers between lobaplatin/paclitaxel- And carboplatin/paclitaxel-based adjuvant chemotherapy in patient with ovarian cancer.,"WHAT IS KNOWN AND OBJECTIVE


To compare short-term therapeutic efficacies and related changes of serum markers from two chemotherapeutic regimes using lobaplatin or carboplatin in combination with paclitaxel in ovarian cancer patients after cytoreductive surgery.
METHODS


120 patients were recruited with pathologically confirmed ovarian cancer. Patients were equally and randomly divided into two groups receiving paclitaxel (PTX) with lobaplatin (LBP) or carboplatin (CBP, as control), respectively, 21 days as a cycle for 6 cycles. Follow-up was performed for 6 months post-treatment. The therapeutic efficacy, serum levels of CA125 (cancer antigen 125/ mucin 16) and HE4 (Human epididymis protein 4) as well as the quality of life were assessment before and after treatment.
RESULTS


No significant difference in therapeutic efficacy was observed between the groups (P > .05). The response rates at 1, 3 and 6 months were 76.7%, 66.7% and 46.7% in the LBP group and 73.3%, 63.3% and 36.7% in the CPB group, respectively. At the end of chemotherapy, serum levels of HE4 and CA125 in both groups returned to normal. However, patients in the LBP group had significantly lower HE4 and CA125 levels than those in the CPB group when examined at 3 or 6 months after chemotherapy (P < .05). Moreover, at the end of follow-up, the quality-of-life score (QLQ-C30) of the LBP group was better than that of the CBP group with statistical significance (P < .05).
WHAT IS NEW AND CONCLUSION


Both lobaplatin and carboplatin have decent anti-tumour efficacy to be involved in the standard platinum/paclitaxel-based chemotherapy against ovarian cancer. Lobaplatin, on the other hand, has demonstrated higher efficacy to control the progress of the disease yet less toxicity to warrant better patient quality of life.",2020,"However, patients in the LBP group had significantly lower HE4 and CA125 levels than those in the CPB group when examined at 3 or 6 months after chemotherapy (P < .05).","['120 patients were recruited with pathologically confirmed ovarian cancer', 'patient with ovarian cancer', 'ovarian cancer patients after cytoreductive surgery']","['lobaplatin/paclitaxel- And carboplatin/paclitaxel-based adjuvant chemotherapy', 'paclitaxel (PTX) with lobaplatin (LBP) or carboplatin (CBP, as control', 'paclitaxel', 'LBP', 'CBP', 'lobaplatin and carboplatin', 'lobaplatin or carboplatin']","['serum levels of HE4 and CA125', 'response rates', 'therapeutic efficacy, serum levels of CA125 (cancer antigen 125/ mucin 16) and HE4 (Human epididymis protein 4', 'HE4 and CA125 levels', 'quality of life', 'quality-of-life score (QLQ-C30', 'therapeutic efficacy']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}, {'cui': 'C3850079', 'cui_str': 'Cytoreductive surgery'}]","[{'cui': 'C0165747', 'cui_str': 'lobaplatin'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0301039', 'cui_str': '1-chloro-3-bromopropene-1'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0903042', 'cui_str': 'Human epididymis protein 4'}, {'cui': 'C0006610', 'cui_str': 'Cancer antigen 125'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0003320', 'cui_str': 'Antigen'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",120.0,0.0272369,"However, patients in the LBP group had significantly lower HE4 and CA125 levels than those in the CPB group when examined at 3 or 6 months after chemotherapy (P < .05).","[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Gynecology, Shangluo Central Hospital, Shanxi, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, Shangluo Central Hospital, Shanxi, China.'}, {'ForeName': 'Boyong', 'Initials': 'B', 'LastName': 'Ding', 'Affiliation': 'Department of Oncology, Shangluo Central Hospital, Shanxi, China.'}]",Journal of clinical pharmacy and therapeutics,['10.1111/jcpt.13276']
2277,33098171,Influence of surgical technique and timing of primary repair on interarch relationship in UCLP: A randomized clinical trial.,"OBJECTIVE


To compare dental arch relationships in children with unilateral cleft lip and palate (UCLP) between two surgical techniques for repair of cleft lip/palate and two ages of palate repair.
SETTINGS AND SAMPLE


Dental models were taken for a group of 448 subjects at a mean age of 7 years and were evaluated by means of the Goslon Yardstick. The patients studied consisted of an initial group of 673 infants with complete UCLP randomized into 8 study groups according to: lip repair procedures (Millard versus Spina techniques); palate repair procedures (von Langenbeck versus Furlow techniques); palate repair timing (early: 9 to 12 months versus late: 15 to 18 months).
METHODS


Four surgeons performed all surgeries. Dependent variables included: lip repair technique, palate repair technique, age at time of palate repair, and surgeon; with sex as an independent variable. The data were analyzed using a general linear model (p<0.05).
RESULTS


There were no significant differences for occlusal index scores as a function of lip or palate surgical technique, palatal repair timing and sex. Significant differences were found for occlusal index scores as a function of the surgeon.
CONCLUSION


Dental arch relationships were not influenced by lip and palatal repair techniques or patient age at palatal repair. The surgeon was the major factor that influenced the dental arch relationship outcome.",2020,"There were no significant differences for occlusal index scores as a function of lip or palate surgical technique, palatal repair timing and sex.","['448 subjects at a mean age of 7 years and were evaluated by means of the Goslon Yardstick', 'patients studied consisted of an initial group of 673 infants with complete UCLP randomized into 8 study groups according to', 'UCLP', 'Four surgeons performed all surgeries', 'children with unilateral cleft lip and palate (UCLP) between two surgical techniques for repair of cleft lip/palate and two ages of palate repair']","['surgical technique and timing of primary repair', 'lip repair procedures (Millard versus Spina techniques); palate repair procedures (von Langenbeck versus Furlow techniques); palate repair timing (early: 9 to 12 months versus late: 15 to 18 months']","['function of lip or palate surgical technique, palatal repair timing and sex', 'occlusal index scores', 'lip repair technique, palate repair technique, age at time of palate repair, and surgeon; with sex as an independent variable']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0158651', 'cui_str': 'Complete unilateral cleft lip'}, {'cui': 'C0700374', 'cui_str': 'Palatal'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0158646', 'cui_str': 'Cleft palate with cleft lip'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0192070', 'cui_str': 'Repair of cleft lip'}, {'cui': 'C0337358', 'cui_str': 'Repair of palate'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0449243', 'cui_str': 'Timing'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0192038', 'cui_str': 'Repair of lip'}, {'cui': 'C0337358', 'cui_str': 'Repair of palate'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205087', 'cui_str': 'Late'}]","[{'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0023759', 'cui_str': 'Lip structure'}, {'cui': 'C0700374', 'cui_str': 'Palatal'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0449243', 'cui_str': 'Timing'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0447303', 'cui_str': 'Structure of occlusal surface of tooth'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0192038', 'cui_str': 'Repair of lip'}, {'cui': 'C0337358', 'cui_str': 'Repair of palate'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0439828', 'cui_str': 'Variable'}]",673.0,0.0839157,"There were no significant differences for occlusal index scores as a function of lip or palate surgical technique, palatal repair timing and sex.","[{'ForeName': 'T O', 'Initials': 'TO', 'LastName': 'Ozawa', 'Affiliation': 'Department of Orthodontics, Hospital of Rehabilitation of Craniofacial Anomalies, University of São Paulo, Bauru, Brazil.'}, {'ForeName': 'J C R', 'Initials': 'JCR', 'LastName': 'Dutka', 'Affiliation': 'Department of Speech-Language and Audiology, Bauru Dental School and Hospital for Rehabilitation of Craniofacial Anomalies, University of São Paulo, Bauru, Brazil.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Garib', 'Affiliation': 'Department of Orthodontics, Hospital of Rehabilitation of Craniofacial Anomalies, University of São Paulo, Bauru, Brazil.'}, {'ForeName': 'R C M C', 'Initials': 'RCMC', 'LastName': 'Lauris', 'Affiliation': 'Department of Orthodontics, Hospital of Rehabilitation of Craniofacial Anomalies, University of São Paulo, Bauru, Brazil.'}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Almeida', 'Affiliation': 'Department of Orthodontics, Hospital of Rehabilitation of Craniofacial Anomalies, University of São Paulo, Bauru, Brazil.'}, {'ForeName': 'T V S', 'Initials': 'TVS', 'LastName': 'Brosco', 'Affiliation': 'Department of Plastic Surgery, Hospital for Rehabilitation of Craniofacial Anomalies, University of São Paulo, Bauru, Brazil.'}, {'ForeName': 'J R P', 'Initials': 'JRP', 'LastName': 'Lauris', 'Affiliation': 'Department of Orthodontics, Bauru Dental School and Hospital for Rehabilitation of Craniofacial Anomalies, University of São Paulo, Bauru, Brazil.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Dolce', 'Affiliation': 'University of Florida College of Dentistry, Gainesville, Florida, USA.'}, {'ForeName': 'M I', 'Initials': 'MI', 'LastName': 'Pegoraro-Krook', 'Affiliation': 'Department of Speech-Language and Audiology, Bauru Dental School and Hospital for Rehabilitation of Craniofacial Anomalies, University of São Paulo, Bauru, Brazil.'}]",Orthodontics & craniofacial research,['10.1111/ocr.12435']
2278,33098330,Immersive virtual reality vs. non-immersive distraction for pain management of children during bone pins and sutures removal: A randomized clinical trial protocol.,"AIMS


To examine the efficacy of an immersive virtual reality distraction compared with an active non-immersive distraction, such as video games on a tablet, for pain and anxiety management and memory of pain and anxiety in children requiring percutaneous bone pins and/or suture removal procedures.
DESIGN


Three-centre randomized clinical trial using a parallel design with two groups: experimental and control.
METHODS


Study to take place in the orthopaedic department of three children hospital of the Montreal region starting in 2019. Children, from 7-17 years old, requiring bone pins and/or suture removal procedures will be recruited. The intervention group (N = 94) will receive a virtual reality game (Dreamland), whereas the control group (N = 94) will receive a tablet with video games. The primary outcomes will be both the mean self-reported pain score measured by the Numerical Rating Scale and mean anxiety score, measured by the Child Fear Scale. Recalls of pain and anxiety will be measured 1 week after the procedure using the same scales. We aim to recruit 188 children to achieve a power of 80% with a significance level (alpha) of 5%.
DISCUSSION


While multiple pharmacological methods have previously been tested for children, no studies have evaluated the impact of immersive virtual reality distraction for pain and anxiety management in the orthopaedic setting.
IMPACT


Improved pain management can be achieved using virtual reality during medical procedures for children. This method is innovative, non-pharmacological, adapted to the hospital setting, and user-friendly.
TRIAL REGISTRATION


NCT03680625, registered on clinicaltrials.gov.",2020,"To examine the efficacy of an immersive virtual reality distraction compared with an active non-immersive distraction, such as video games on a tablet, for pain and anxiety management and memory of pain and anxiety in children requiring percutaneous bone pins and/or suture removal procedures.
","['children requiring percutaneous bone pins and/or suture removal procedures', '188 children to achieve a power of 80% with a significance level (alpha) of 5', 'Children, from 7-17\xa0years old, requiring bone pins and/or suture removal procedures will be recruited', 'children during bone pins and sutures removal', 'Study to take place in the orthopaedic department of three children hospital of the Montreal region starting in 2019']","['active non-immersive distraction, such as video games', 'virtual reality game (Dreamland), whereas the control group (N\xa0=\xa094) will receive a tablet with video games', 'Immersive virtual reality vs. non-immersive distraction', 'immersive virtual reality distraction']","['Recalls of pain and anxiety', 'mean self-reported pain score', 'pain and anxiety management and memory of pain and anxiety', 'Numerical Rating Scale and mean anxiety score, measured by the Child Fear Scale']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0175718', 'cui_str': 'Bone pin'}, {'cui': 'C0184936', 'cui_str': 'Removal of suture'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0587525', 'cui_str': 'Orthopedic department'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439659', 'cui_str': 'Origins'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0150189', 'cui_str': 'Distraction training'}, {'cui': 'C0042649', 'cui_str': 'Video Games'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0871652', 'cui_str': 'Management of anxiety'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0015726', 'cui_str': 'Fear'}]",3.0,0.107502,"To examine the efficacy of an immersive virtual reality distraction compared with an active non-immersive distraction, such as video games on a tablet, for pain and anxiety management and memory of pain and anxiety in children requiring percutaneous bone pins and/or suture removal procedures.
","[{'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Le May', 'Affiliation': 'Research Center, CHU Sainte-Justine, Montreal, QC, Canada.'}, {'ForeName': 'Argerie', 'Initials': 'A', 'LastName': 'Tsimicalis', 'Affiliation': 'Ingram School of Nursing, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Noel', 'Affiliation': 'Department of Psychology, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Rainville', 'Affiliation': 'Faculty of Dental Medicine, Université de Montréal, Montreal, QC, Canada.'}, {'ForeName': 'Christelle', 'Initials': 'C', 'LastName': 'Khadra', 'Affiliation': 'Faculty of Medicine, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Ariane', 'Initials': 'A', 'LastName': 'Ballard', 'Affiliation': 'Ingram School of Nursing, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Estelle', 'Initials': 'E', 'LastName': 'Guingo', 'Affiliation': 'UQAT Université du Québec en Abitibi-Témiscamingue, Rouyn-Noranda, QC, Canada.'}, {'ForeName': 'Casey', 'Initials': 'C', 'LastName': 'Cotes-Turpin', 'Affiliation': 'UQAT Université du Québec en Abitibi-Témiscamingue, Rouyn-Noranda, QC, Canada.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Addab', 'Affiliation': ""Shriners' Hospital for children in Montreal, Montreal, QC, Canada.""}, {'ForeName': 'Khadidja', 'Initials': 'K', 'LastName': 'Chougui', 'Affiliation': ""Shriners' Hospital for children in Montreal, Montreal, QC, Canada.""}, {'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Francoeur', 'Affiliation': 'Research Center, CHU Sainte-Justine, Montreal, QC, Canada.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Hung', 'Affiliation': 'Research Center, CHU Sainte-Justine, Montreal, QC, Canada.'}, {'ForeName': 'Mitchell', 'Initials': 'M', 'LastName': 'Bernstein', 'Affiliation': 'Division of Orthopaedic Surgery, McGill University Health Centre, Montreal, QC, Canada.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Bouchard', 'Affiliation': 'UQO Université du Québec en Outaouais, Saint-Jérôme, QC, Canada.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Parent', 'Affiliation': 'Department of Surgery, CHU Sainte-Justine, Montreal, QC, Canada.'}, {'ForeName': 'Mathilde', 'Initials': 'M', 'LastName': 'Hupin Debeurme', 'Affiliation': 'Department of Surgery, CHU Sainte-Justine, Montreal, QC, Canada.'}]",Journal of advanced nursing,['10.1111/jan.14607']
2279,33098382,The Effect of N-Acetyl-Cysteine on  NRF2  Antioxidant Gene Expression in Asthenoteratozoospermia Men: A Clinical Trial Study.,"Background


One of the important factor associated with male infertility is high production of reactive oxygen species (ROS). The main function of Nuclear factor erythroid 2-related factor 2 ( NRF2 ) is to activate the cellular antioxidant response by inducing the transcription of a wide array of genes that can combat the harmful effects of factors such as oxidative stress. The purpose of this study was to evaluate the effect of N-acetyl-L-cysteine (NAC), as an antioxidant drug, on NRF2 Gene Expression in Asthenoteratozoospermia Men.
Materials and Methods


In this randomized, blinded clinical trial study, included 50 infertile men with asthenoteratozoospermia, who received NAC (600 mg, three times daily). Sperm parameters analyzed according to the world health organization (WHO; 2010). Sperm DNA fragmentation, relative  NRF2  expression, and seminal plasma level of antioxidant enzymes were measured by TUNEL assay, reverse transcription polymerase chain reaction (RT-PCR) and ELISA test, respectively.
Results


After NAC treatment, findings showed a significant increase in sperm concentration and motility compared to pre-treatment status, whereas the percentage of abnormal morphology and DNA fragmentation was significantly decreased (P<0.05). A significant improvement in expression of  NRF2  gene and antioxidant enzyme levels were observed compared to pre-treatment by NAC (P<0.05). Significant correlations were observed between NRF2 mRNA expression level, specific sperm parameters and level of antioxidant enzymes (P<0.05).
Conclusion


The results demonstrated that NAC oral supplementation protected against oxidative stress by enhancing NRF2 expression. This could improve semen parameters quality parameters in asthenoteratozoospermia men (Registration number: IRCT20170830035998N4).",2020,A significant improvement in expression of  NRF2  gene and antioxidant enzyme levels were observed compared to pre-treatment by NAC (P<0.05).,"['Asthenoteratozoospermia Men', '50 infertile men with asthenoteratozoospermia, who received']","['N-Acetyl-Cysteine', 'NAC', 'N-acetyl-L-cysteine (NAC']","['expression of  NRF2  gene and antioxidant enzyme levels', 'oxidative stress', 'NRF2 mRNA expression level, specific sperm parameters and level of antioxidant enzymes', 'Antioxidant Gene Expression', 'Sperm DNA fragmentation, relative  NRF2  expression, and seminal plasma level of antioxidant enzymes', 'sperm concentration and motility', 'percentage of abnormal morphology and DNA fragmentation']","[{'cui': 'C0403823', 'cui_str': 'Asthenospermia'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}]","[{'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}]","[{'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C1565078', 'cui_str': 'NFE2L2 protein, human'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0014440', 'cui_str': 'Enzyme measurement'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0037868', 'cui_str': 'Spermatozoa'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0014442', 'cui_str': 'Enzyme'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0376669', 'cui_str': 'DNA Fragmentation'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0242499', 'cui_str': 'Seminal plasma'}, {'cui': 'C0429845', 'cui_str': 'Sperm concentration measurement'}, {'cui': 'C0007608', 'cui_str': 'Motility, Cell'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}]",50.0,0.128508,A significant improvement in expression of  NRF2  gene and antioxidant enzyme levels were observed compared to pre-treatment by NAC (P<0.05).,"[{'ForeName': 'Rahil', 'Initials': 'R', 'LastName': 'Jannatifar', 'Affiliation': 'Department of Biology, Science and Research Branch, Islamic Azad University, Tehran, Iran.'}, {'ForeName': 'Kazem', 'Initials': 'K', 'LastName': 'Parivar', 'Affiliation': 'Department of Biology, Science and Research Branch, Islamic Azad University, Tehran, Iran.'}, {'ForeName': 'Nasim', 'Initials': 'N', 'LastName': 'Hayati Roodbari', 'Affiliation': 'Department of Biology, Science and Research Branch, Islamic Azad University, Tehran, Iran.'}, {'ForeName': 'Mohammad Hossein', 'Initials': 'MH', 'LastName': 'Nasr-Esfahani', 'Affiliation': 'Department of Reproductive Biotechnology, Reproductive Biomedicine Research Center, Royan Institute for Biotechnology, ACECR, Isfahan, Iran. Electronic Address: mh.nasr-esfahani@royaninstitute.org.'}]",International journal of fertility & sterility,['10.22074/ijfs.2020.44411']
2280,33098411,Atrial nitroso-redox balance and refractoriness following on-pump cardiac surgery: A randomised trial of atorvastatin.,"AIMS


Systemic inflammation and increased activity of atrial NOX2-containing NADPH oxidases have been associated with the new onset of atrial fibrillation (AF) after cardiac surgery. In addition to lowering LDL-cholesterol, statins exert rapid anti-inflammatory and antioxidant effects, the clinical significance of which remains controversial.
METHODS AND RESULTS


We first assessed the impact of cardiac surgery and cardiopulmonary bypass (CPB) on atrial nitroso-redox balance by measuring NO synthase (NOS) and GTP Cyclohydrolase -1 (GCH-1) activity, biopterin content, and superoxide production in paired samples of the right atrial appendage obtained before (PRE) and after CPB and reperfusion (POST) in 116 patients. The effect of perioperative treatment with atorvastatin (80 mg once daily) on these parameters, blood biomarkers and the postoperative atrial effective refractory period (AERP) was then evaluated in a randomized, double-blind, placebo-controlled study in 80 patients undergoing cardiac surgery on CPB.CPB and reperfusion led to a significant increase in atrial superoxide production (74% CI, 71-76%, n = 46 paired samples, P < 0.0001) and a reduction in atrial tetrahydrobiopterin (BH4) (34% CI, 33-35%, n = 36 paired samples, P < 0.01), and in GCH-1 (56% CI, 55-58%, n = 26 paired samples, P < 0.001) and NOS activity (58% CI, 52-67%, n = 20 paired samples, P < 0.001). Perioperative atorvastatin treatment prevented the effect of CPB and reperfusion on all parameters but had no significant effect on the postoperative right AERP, troponin release, or NT-pro BNP after cardiac surgery.
CONCLUSIONS


Perioperative statin therapy prevents post-reperfusion atrial nitroso-redox imbalance in patients undergoing on-pump cardiac surgery but has no significant impact on postoperative atrial refractoriness, perioperative myocardial injury, or markers of postoperative LV function.Clinical Trial Registration information: https://clinicaltrials.gov/ct2/show/NCT01780740.
TRANSLATIONAL PERSPECTIVE


Increased atrial ROS production is associated with both incident and prevalent AF, with experimental findings suggesting it may have a causal role in AF induction and AF-induced electrical remodelling. Statin therapy causes a reduction in myocardial and vascular ROS production and as such it may prevent the new onset of AF after cardiac surgery. In patients undergoing on-pump cardiac surgery, we show that perioperative administration of statins prevents myocardial nitroso-redox imbalance after reperfusion without affecting atrial refractoriness or perioperative myocardial injury. These findings suggest that targeting myocardial nitroso-redox imbalance would be unlikely to prevent postoperative complications in patients undergoing on-pump cardiac surgery.",2020,"Perioperative atorvastatin treatment prevented the effect of CPB and reperfusion on all parameters but had no significant effect on the postoperative right AERP, troponin release, or NT-pro BNP after cardiac surgery.
","['80 patients undergoing cardiac surgery on CPB.CPB and reperfusion', '116 patients', 'patients undergoing on-pump cardiac surgery']","['Perioperative atorvastatin', 'Statin therapy', 'statins', 'Atrial nitroso-redox balance and refractoriness following on-pump cardiac surgery', 'placebo', 'Perioperative statin therapy', 'atorvastatin', 'cardiac surgery and cardiopulmonary bypass (CPB']","['NOS activity', 'postoperative atrial refractoriness, perioperative myocardial injury, or markers of postoperative LV function', 'atrial superoxide production', 'reduction in atrial tetrahydrobiopterin (BH4', 'postoperative right AERP, troponin release, or NT-pro BNP', 'myocardial and vascular ROS production', 'postoperative complications', 'myocardial nitroso-redox imbalance', 'atrial nitroso-redox balance by measuring NO synthase (NOS) and GTP Cyclohydrolase -1 (GCH-1) activity, biopterin content, and superoxide production', 'blood biomarkers and the postoperative atrial effective refractory period (AERP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0741847', 'cui_str': 'Bypass'}, {'cui': 'C0035124', 'cui_str': 'Reperfusion'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0182537', 'cui_str': 'Pump'}]","[{'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C0030012', 'cui_str': 'Oxidation-reduction'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}]","[{'cui': 'C0132555', 'cui_str': 'Nitric-oxide synthase'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0038836', 'cui_str': 'Superoxide'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C4281712', 'cui_str': 'Tetrahydrobiopterin'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0041199', 'cui_str': 'Troponin'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0030012', 'cui_str': 'Oxidation-reduction'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0018293', 'cui_str': '7,8-Dihydroneopterintriphosphate Synthetase'}, {'cui': 'C0005562', 'cui_str': 'Biopterin analyte'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0428938', 'cui_str': 'Atrial effective refractory period'}]",80.0,0.299005,"Perioperative atorvastatin treatment prevented the effect of CPB and reperfusion on all parameters but had no significant effect on the postoperative right AERP, troponin release, or NT-pro BNP after cardiac surgery.
","[{'ForeName': 'Raja', 'Initials': 'R', 'LastName': 'Jayaram', 'Affiliation': 'Division of Cardiovascular Medicine, Radcliffe Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Jones', 'Affiliation': 'Cardiology, Oxford Heart Centre, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.'}, {'ForeName': 'Svetlana', 'Initials': 'S', 'LastName': 'Reilly', 'Affiliation': 'Division of Cardiovascular Medicine, Radcliffe Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Crabtree', 'Affiliation': 'Division of Cardiovascular Medicine, Radcliffe Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Nikhil', 'Initials': 'N', 'LastName': 'Pal', 'Affiliation': 'Division of Cardiovascular Medicine, Radcliffe Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Goodfellow', 'Affiliation': 'Division of Cardiovascular Medicine, Radcliffe Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Keshav', 'Initials': 'K', 'LastName': 'Nahar', 'Affiliation': 'Division of Cardiovascular Medicine, Radcliffe Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Jillian', 'Initials': 'J', 'LastName': 'Simon', 'Affiliation': 'Division of Cardiovascular Medicine, Radcliffe Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Carnicer', 'Affiliation': 'Division of Cardiovascular Medicine, Radcliffe Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'DeSilva', 'Affiliation': 'Cardiothoracic Surgery, Oxford Heart Centre, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.'}, {'ForeName': 'Chandana', 'Initials': 'C', 'LastName': 'Ratnatunga', 'Affiliation': 'Cardiothoracic Surgery, Oxford Heart Centre, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Petrou', 'Affiliation': 'Cardiothoracic Surgery, Oxford Heart Centre, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.'}, {'ForeName': 'Rana', 'Initials': 'R', 'LastName': 'Sayeed', 'Affiliation': 'Cardiothoracic Surgery, Oxford Heart Centre, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Roalfe', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, UK.'}, {'ForeName': 'Keith M', 'Initials': 'KM', 'LastName': 'Channon', 'Affiliation': 'Division of Cardiovascular Medicine, Radcliffe Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Yaver', 'Initials': 'Y', 'LastName': 'Bashir', 'Affiliation': 'Cardiology, Oxford Heart Centre, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Betts', 'Affiliation': 'Cardiology, Oxford Heart Centre, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hill', 'Affiliation': 'Clinical Trial Service Unit, Nuffield Department of Population Health, University of Oxford, UK.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Casadei', 'Affiliation': 'Division of Cardiovascular Medicine, Radcliffe Department of Medicine, University of Oxford, Oxford, UK.'}]",Cardiovascular research,['10.1093/cvr/cvaa302']
2281,33098434,Effects of long-term vitamin D and n-3 fatty acid supplementation on inflammatory and cardiac biomarkers in patients with type 2 diabetes: secondary analyses from a randomised controlled trial.,"AIMS/HYPOTHESIS


Interventions that reduce inflammation may delay progression of microvascular and macrovascular complications in diabetes. We examined the effects of vitamin D 3  and/or n-3 fatty acid supplementation vs placebo on 5 year changes in serum inflammatory and cardiac biomarkers in adults with type 2 diabetes.
METHODS


This study reports pre-specified secondary outcomes of the Vitamin D and Omega-3 Trial to Prevent and Treat Diabetic Kidney Disease, in which 1312 US adults with type 2 diabetes and without known cardiovascular disease, malignancy, or end-stage kidney disease were randomised using computer-generated random numbers in blocks of eight to vitamin D 3  (2000 IU/day) vs placebo and n-3 fatty acids (eicosapentaenoic acid [EPA] and docosahexaenoic acid [DHA]; 1 g/day) vs placebo in a 2 × 2 factorial design. Participants, examiners, and researchers assessing outcomes were blinded to intervention assignment. We measured serum IL-6, high-sensitivity C-reactive protein (hsCRP) and N-terminal pro-B-type natriuretic peptide (NT-proBNP) at baseline and after 2 and 5 years.
RESULTS


A total of 333 participants were randomised to vitamin D 3  and placebo n-3 fatty acids, 289 to n-3 fatty acids and placebo vitamin D 3 , 370 to vitamin D 3  and n-3 fatty acids, and 320 to 2 placebos; 989 (75%) and 934 (71%) participants returned blood samples at 2 and 5 years, respectively. Participants had a mean age of 67.6 years (46% women). Overall, baseline geometric means of IL-6, hsCRP and NT-proBNP were 1.2 pg/ml, 1.9 mg/l and 262 ng/l, respectively. After 5 years, mean IL-6 and hsCRP remained within 6% of their baseline values while mean NT-proBNP increased by 55% overall. Compared with placebo, participants assigned to vitamin D 3  had a 1.24-fold greater increase in NT-proBNP over 5 years (95% CI 1.09, 1.41; p = 0.003), while IL-6 and hsCRP did not have a significant difference in change. Comparing n-3 fatty acids with placebo, there was no significant difference in change in IL-6, hsCRP or NT-proBNP. No heterogeneity was observed in subgroup analyses accounting for baseline eGFR, urine albumin to creatinine ratio, initial biomarker concentration, 25-hydroxyvitamin D level or EPA+DHA index.
CONCLUSIONS/INTERPRETATION


Among adults with type 2 diabetes, supplementation with vitamin D 3  or n-3 fatty acids did not reduce IL-6, hsCRP or NT-proBNP over 5 years.
TRIAL REGISTRATION


ClinicalTrials.gov NCT01684722 FUNDING: The study was funded by grant R01DK088762 from the National Institute of Diabetes and Digestive and Kidney Diseases. Graphical abstract.",2020,"Comparing n-3 fatty acids with placebo, there was no significant difference in change in IL-6, hsCRP or NT-proBNP.","['patients with type 2 diabetes', '1312 US adults with type 2 diabetes and without known cardiovascular disease, malignancy, or end-stage kidney disease', 'adults with type 2 diabetes', 'diabetes', '333 participants', 'Participants had a mean age of 67.6\xa0years (46% women']","['vitamin D 3  or n-3 fatty acids', 'vitamin D 3  and/or n-3 fatty acid supplementation vs placebo', 'n-3 fatty acids with placebo', 'vitamin D 3  and placebo n-3 fatty acids, 289 to n-3 fatty acids and placebo vitamin D 3 , 370 to vitamin D 3  and n-3 fatty acids, and 320 to 2 placebos', 'Vitamin D and Omega-3 Trial', 'placebo', 'long-term vitamin D and n-3 fatty acid supplementation', 'placebo and n-3 fatty acids (eicosapentaenoic acid [EPA] and docosahexaenoic acid [DHA']","['Overall, baseline geometric means of IL-6, hsCRP and NT-proBNP', 'mean IL-6 and hsCRP', 'change in IL-6, hsCRP or NT-proBNP', 'mean NT-proBNP', 'NT-proBNP', 'IL-6', 'serum inflammatory and cardiac biomarkers', 'baseline eGFR, urine albumin to creatinine ratio, initial biomarker concentration, 25-hydroxyvitamin D level or EPA+DHA index', 'serum IL-6, high-sensitivity C-reactive protein (hsCRP) and N-terminal pro-B-type natriuretic peptide (NT-proBNP', 'inflammatory and cardiac biomarkers', 'IL-6, hsCRP or NT-proBNP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C4517724', 'cui_str': '333'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0561929', 'cui_str': 'N-3 fatty acid supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4517743', 'cui_str': '370'}, {'cui': 'C4517711', 'cui_str': '320'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0142831', 'cui_str': 'sodium dehydroacetate'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0042038', 'cui_str': 'Albumin urine'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}]",333.0,0.737164,"Comparing n-3 fatty acids with placebo, there was no significant difference in change in IL-6, hsCRP or NT-proBNP.","[{'ForeName': 'Christine P', 'Initials': 'CP', 'LastName': 'Limonte', 'Affiliation': 'Division of Nephrology, Department of Medicine, University of Washington, Seattle, WA, USA. climonte@uw.edu.'}, {'ForeName': 'Leila R', 'Initials': 'LR', 'LastName': 'Zelnick', 'Affiliation': 'Division of Nephrology, Department of Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Ruzinski', 'Affiliation': 'Kidney Research Institute, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Andrew N', 'Initials': 'AN', 'LastName': 'Hoofnagle', 'Affiliation': 'Division of Nephrology, Department of Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Thadhani', 'Affiliation': 'Office of the Chief Academic Officer, Partners HealthCare, Boston, MA, USA.'}, {'ForeName': 'Michal L', 'Initials': 'ML', 'LastName': 'Melamed', 'Affiliation': 'Division of Nephrology, Department of Medicine, Albert Einstein College of Medicine, Bronx, NY, USA.'}, {'ForeName': 'I-Min', 'Initials': 'IM', 'LastName': 'Lee', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Julie E', 'Initials': 'JE', 'LastName': 'Buring', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Howard D', 'Initials': 'HD', 'LastName': 'Sesso', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'JoAnn E', 'Initials': 'JE', 'LastName': 'Manson', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Ian H', 'Initials': 'IH', 'LastName': 'de Boer', 'Affiliation': 'Division of Nephrology, Department of Medicine, University of Washington, Seattle, WA, USA.'}]",Diabetologia,['10.1007/s00125-020-05300-7']
2282,33098565,Comparison of Visceral Fat Reduction by Ipragliflozin and Metformin in Elderly Type 2 Diabetes Patients: Sub-Analysis of a Randomized-Controlled Study.,"INTRODUCTION


To compare the effects of ipragliflozin, a sodium-glucose transporter 2 inhibitor, with those of metformin on visceral fat (as well as muscles and bones) in Japanese elderly patients with type 2 diabetes (T2D), we conducted a sub-analysis of a prospective, multicenter, blinded-endpoint randomized-controlled study.
METHODS


In total, 103 patients with T2D (body mass index ≥ 22 kg/m 2 ; glycated hemoglobin, 7-10%) and being treated with sitagliptin (a dipeptidyl peptidase-4 inhibitor) were included and randomized to receive ipragliflozin or metformin. The primary outcome was the change in visceral fat area measured using computed tomography 24 weeks following treatment. The secondary outcomes included changes in subcutaneous and total fat area, muscle volume, bone density measured using computed tomography, handgrip strength, bone markers, plasma glucose, insulin, homeostasis model assessment (HOMA)2-beta, HOMA2-R, glycated hemoglobin, lipid panel, uric acid, blood pressure, adiponectin, and high-sensitivity C-reactive protein. All patients aged 65-74 years were selected for sub-analysis.
RESULTS


The sub-analysis included 15 and 14 patients in the ipragliflozin and metformin groups, respectively. The patients' backgrounds were well balanced. Visceral fat area reduction was greater in the ipragliflozin group than in the metformin group (- 10.58% vs. - 6.93%; P = 0.034). There were significant differences in the changes in bone absorption markers, uric acid, and total cholesterol levels between the groups.
CONCLUSION


Ipragliflozin significantly reduced the visceral fat area compared with metformin when added to sitagliptin in elderly patients with T2D. Long-term and large-scale studies are required to elucidate whether ipragliflozin is suitable for elderly patients.
TRIAL REGISTRATION


The study was registered at https://www.umin.ac.jp/ctr/ (UMIN-ID: UMIN 000015170).",2020,"Ipragliflozin significantly reduced the visceral fat area compared with metformin when added to sitagliptin in elderly patients with T2D. Long-term and large-scale studies are required to elucidate whether ipragliflozin is suitable for elderly patients.
","['Elderly Type 2 Diabetes', 'All patients aged 65-74\xa0years were selected for sub-analysis', 'Patients', 'elderly patients', '103 patients with T2D (body mass index\u2009≥\u200922\xa0kg', 'Japanese elderly patients with type 2 diabetes (T2D']","['ipragliflozin', 'ipragliflozin and metformin', 'ipragliflozin, a sodium-glucose transporter 2 inhibitor, with those of metformin', 'metformin', 'Ipragliflozin', 'Ipragliflozin and Metformin', 'ipragliflozin or metformin', 'sitagliptin (a dipeptidyl peptidase-4 inhibitor']","['change in visceral fat area measured using computed tomography', 'changes in subcutaneous and total fat area, muscle volume, bone density measured using computed tomography, handgrip strength, bone markers, plasma glucose, insulin, homeostasis model assessment (HOMA)2-beta, HOMA2-R, glycated hemoglobin, lipid panel, uric acid, blood pressure, adiponectin, and high-sensitivity C-reactive protein', 'Visceral fat area reduction', 'visceral fat area', 'bone absorption markers, uric acid, and total cholesterol levels']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}]","[{'cui': 'C3492889', 'cui_str': 'ipragliflozin'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C3273807', 'cui_str': 'SGLT2 Inhibitors'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C1827106', 'cui_str': 'Dipeptidyl peptidase IV inhibitor'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0181734', 'cui_str': 'Bone marker'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C1829779', 'cui_str': 'Homeostasis model assessment'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0200382', 'cui_str': 'Lipid panel'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",103.0,0.0485089,"Ipragliflozin significantly reduced the visceral fat area compared with metformin when added to sitagliptin in elderly patients with T2D. Long-term and large-scale studies are required to elucidate whether ipragliflozin is suitable for elderly patients.
","[{'ForeName': 'Masaya', 'Initials': 'M', 'LastName': 'Koshizaka', 'Affiliation': 'Department of Diabetes, Metabolism and Endocrinology, Chiba University Hospital, 1-8-1 Inohana, Chuo-ku, Chiba City, Chiba, 260-8677, Japan. overslope@chiba-u.jp.'}, {'ForeName': 'Ko', 'Initials': 'K', 'LastName': 'Ishikawa', 'Affiliation': 'Department of Diabetes, Metabolism and Endocrinology, Chiba University Hospital, 1-8-1 Inohana, Chuo-ku, Chiba City, Chiba, 260-8677, Japan.'}, {'ForeName': 'Ryoichi', 'Initials': 'R', 'LastName': 'Ishibashi', 'Affiliation': 'Department of Endocrinology, Hematology and Gerontology, Chiba University Graduate School of Medicine, 1-8-1 Inohana, Chuo-ku, Chiba City, Chiba, 260-8670, Japan.'}, {'ForeName': 'Sho', 'Initials': 'S', 'LastName': 'Takahashi', 'Affiliation': 'Clinical Research Support Center, The Jikei University School of Medicine, 3-25-8 Nishi-Shimbashi, Minato-ku, Tokyo, 105-8461, Japan.'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Sakamoto', 'Affiliation': 'Department of Endocrinology, Hematology and Gerontology, Chiba University Graduate School of Medicine, 1-8-1 Inohana, Chuo-ku, Chiba City, Chiba, 260-8670, Japan.'}, {'ForeName': 'Hidetaka', 'Initials': 'H', 'LastName': 'Yokoh', 'Affiliation': 'Department of Diabetes, Metabolism and Endocrinology, Chiba University Hospital, 1-8-1 Inohana, Chuo-ku, Chiba City, Chiba, 260-8677, Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Baba', 'Affiliation': 'Department of Diabetes, Metabolism and Endocrinology, Chiba University Hospital, 1-8-1 Inohana, Chuo-ku, Chiba City, Chiba, 260-8677, Japan.'}, {'ForeName': 'Shintaro', 'Initials': 'S', 'LastName': 'Ide', 'Affiliation': 'Department of Diabetes, Metabolism and Endocrinology, Chiba University Hospital, 1-8-1 Inohana, Chuo-ku, Chiba City, Chiba, 260-8677, Japan.'}, {'ForeName': 'Kana', 'Initials': 'K', 'LastName': 'Ide', 'Affiliation': 'Department of Diabetes, Metabolism and Endocrinology, Chiba University Hospital, 1-8-1 Inohana, Chuo-ku, Chiba City, Chiba, 260-8677, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Ishikawa', 'Affiliation': 'Department of Endocrinology, Hematology and Gerontology, Chiba University Graduate School of Medicine, 1-8-1 Inohana, Chuo-ku, Chiba City, Chiba, 260-8670, Japan.'}, {'ForeName': 'Shunichiro', 'Initials': 'S', 'LastName': 'Onishi', 'Affiliation': 'Department of Diabetes and Metabolism, Asahi General Hospital, 1326 I, Asahi City, Chiba, 289-2511, Japan.'}, {'ForeName': 'Kazuki', 'Initials': 'K', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Endocrinology, Hematology and Gerontology, Chiba University Graduate School of Medicine, 1-8-1 Inohana, Chuo-ku, Chiba City, Chiba, 260-8670, Japan.'}, {'ForeName': 'Minoru', 'Initials': 'M', 'LastName': 'Takemoto', 'Affiliation': 'Department of Endocrinology, Hematology and Gerontology, Chiba University Graduate School of Medicine, 1-8-1 Inohana, Chuo-ku, Chiba City, Chiba, 260-8670, Japan.'}, {'ForeName': 'Takuro', 'Initials': 'T', 'LastName': 'Horikoshi', 'Affiliation': 'Diagnostic Radiology and Radiation Oncology, Chiba University Graduate School of Medicine, 1-8-1 Inohana, Chuo-ku, Chiba City, Chiba, 260-8670, Japan.'}, {'ForeName': 'Ryota', 'Initials': 'R', 'LastName': 'Shimofusa', 'Affiliation': 'Department of Radiology, Sannou Hospital, 166-2 Sannou-chou, Inage-ku, Chiba City, Chiba, 263-0002, Japan.'}, {'ForeName': 'Yoshiro', 'Initials': 'Y', 'LastName': 'Maezawa', 'Affiliation': 'Department of Diabetes, Metabolism and Endocrinology, Chiba University Hospital, 1-8-1 Inohana, Chuo-ku, Chiba City, Chiba, 260-8677, Japan.'}, {'ForeName': 'Koutaro', 'Initials': 'K', 'LastName': 'Yokote', 'Affiliation': 'Department of Diabetes, Metabolism and Endocrinology, Chiba University Hospital, 1-8-1 Inohana, Chuo-ku, Chiba City, Chiba, 260-8677, Japan.'}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-020-00949-0']
2283,30887250,"A phase I, dose-escalation study of PF-06650808, an anti-Notch3 antibody-drug conjugate, in patients with breast cancer and other advanced solid tumors.","Background PF-06650808 is a novel anti-Notch3 antibody-drug conjugate (ADC) able to deliver an auristatin-based cytotoxic payload to target cells. In this first-in-human, dose-finding, phase I study (NCT02129205), we investigated safety, pharmacokinetics, immunogenicity, and preliminary antitumor activity of single-agent PF-06650808 in 40 patients with advanced breast cancer (BC) and other solid tumors unselected for Notch3 expression. Primary endpoint was dose-limiting toxicity (DLT). PF-06650808 was administered intravenously every 3 weeks at a starting dose of 0.2 mg/kg, escalated up to 6.4 mg/kg following the modified continual reassessment method. An additional dose level, 2.0 mg/kg, was evaluated in patients with advanced, estrogen receptor-positive (ER + ) BC. Results The majority of patients had advanced BC (60%) and almost all (90%) had received ≥3 prior lines of anticancer therapy. Treatment with PF-06650808 was generally well tolerated at dose levels ≤2.0 mg/kg with no DLTs. The maximum tolerated dose (MTD) was estimated to be 2.4 mg/kg. The most common treatment-related AEs in all patients were fatigue (40.0%), decreased appetite (37.5%), nausea (35.0%), alopecia (32.5%), abdominal pain (25.0%), pruritus (25.0%), and vomiting (25.0%). Five patients achieved a partial response (PR), including 2 unconfirmed PRs; 4 of the responders had ER + /PR + /HER2 -  BC. Sixteen (51.6%) patients achieved stable disease, including 8 (57.1%) of 14 patients with ER +  BC. Tumor samples from all responders tested positive for NOTCH3 expression in a retrospective, exploratory analysis. Conclusions The anti-Notch3 ADC PF-06650808 has demonstrated a manageable safety profile and early signs of antitumor activity in patients with advanced BC.",2020,"The most common treatment-related AEs in all patients were fatigue (40.0%), decreased appetite (37.5%), nausea (35.0%), alopecia (32.5%), abdominal pain (25.0%), pruritus (25.0%), and vomiting (25.0%).","['patients with advanced, estrogen receptor-positive (ER + ) BC', '40 patients with advanced breast cancer (BC) and other solid tumors unselected for Notch3 expression', 'patients with breast cancer and other advanced solid tumors', 'patients with advanced BC']",[],"['pruritus', 'dose-limiting toxicity (DLT', 'abdominal pain', 'vomiting', 'stable disease', 'nausea', 'maximum tolerated dose (MTD', 'alopecia', 'decreased appetite', 'safety, pharmacokinetics, immunogenicity, and preliminary antitumor activity', 'partial response (PR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0279754', 'cui_str': 'ESR1 positive'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C1452875', 'cui_str': 'NOTCH3 protein, human'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}]",[],"[{'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0752079', 'cui_str': 'Maximal Tolerated Dose'}, {'cui': 'C0002170', 'cui_str': 'Alopecia'}, {'cui': 'C0232462', 'cui_str': 'Decrease in appetite'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0439611', 'cui_str': 'Preliminary'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}]",40.0,0.0706019,"The most common treatment-related AEs in all patients were fatigue (40.0%), decreased appetite (37.5%), nausea (35.0%), alopecia (32.5%), abdominal pain (25.0%), pruritus (25.0%), and vomiting (25.0%).","[{'ForeName': 'Lee S', 'Initials': 'LS', 'LastName': 'Rosen', 'Affiliation': 'David Geffen School of Medicine, Division of Hematology-Oncology, University of California Los Angeles Medical Center, 2020 Santa Monica Blvd., Ste. 600, Santa Monica, CA, 90404, USA. LRosen@mednet.ucla.edu.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Wesolowski', 'Affiliation': 'Ohio State University Comprehensive Cancer Center, 320 West 10th Ave., Columbus, OH, 43210, USA.'}, {'ForeName': 'Raffaele', 'Initials': 'R', 'LastName': 'Baffa', 'Affiliation': 'Pfizer, 10724 Science Center Drive, San Diego, CA, 92121, USA.'}, {'ForeName': 'Kai-Hsin', 'Initials': 'KH', 'LastName': 'Liao', 'Affiliation': 'Pfizer, 10724 Science Center Drive, San Diego, CA, 92121, USA.'}, {'ForeName': 'Steven Y', 'Initials': 'SY', 'LastName': 'Hua', 'Affiliation': 'Pfizer, 10724 Science Center Drive, San Diego, CA, 92121, USA.'}, {'ForeName': 'Brenda L', 'Initials': 'BL', 'LastName': 'Gibson', 'Affiliation': 'Pfizer, 10724 Science Center Drive, San Diego, CA, 92121, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Pirie-Shepherd', 'Affiliation': 'Pfizer, 10724 Science Center Drive, San Diego, CA, 92121, USA.'}, {'ForeName': 'Anthony W', 'Initials': 'AW', 'LastName': 'Tolcher', 'Affiliation': 'START Center for Cancer Care, 4383 Medical Dr., San Antonio, TX, 78229, USA.'}]",Investigational new drugs,['10.1007/s10637-019-00754-y']
2284,31043691,Systemic inflammation is associated with malaria and preterm birth in women living with HIV on antiretrovirals and co-trimoxazole.,"Women living with HIV (WLHIV) have an increased risk of malaria in pregnancy (MiP). It is unclear if MiP in WLHIV causes a systemic inflammatory response and increases the risk of adverse birth outcomes, especially for women receiving antiretroviral therapy (ART) and daily trimethoprim-sulfamethoxazole (TMP/SXT). We analyzed repeated plasma samples in a cohort of malaria-exposed Ugandan WLHIV receiving ART and daily TMP/SXT to examine changes in inflammatory markers across pregnancy and their association with birth outcomes. Concentrations of CHI3L1, CRP, IL-18BP, IL-6, sICAM-1, and sTNFR2 were quantified by ELISA in 1115 plasma samples collected over pregnancy from 326 women. MiP was associated with increased sTNFR2, sICAM-1 and IL-18BP concentrations across pregnancy. Women who delivered preterm had elevated concentrations of sTNFR2 and altered levels of IL-6 during pregnancy. Women with sTNFR2 concentrations in the highest quartile within 6 weeks of delivery had an increased relative risk of preterm birth. Our results indicate that despite daily TMP/SXT, MiP in WLHIV induced a systemic inflammatory response that was associated with an increased risk of preterm birth. These findings highlight the need for additional strategies to protect WLHIV from malaria infection in pregnancy to promote healthy outcomes for mother and child.",2019,"Concentrations of CHI3L1, CRP, IL-18BP, IL-6, sICAM-1, and sTNFR2 were quantified by ELISA in 1115 plasma samples collected over pregnancy from 326 women.","['women receiving antiretroviral therapy (ART) and daily', 'Women living with HIV (WLHIV', 'women living with HIV on antiretrovirals and co-trimoxazole']","['trimethoprim-sulfamethoxazole (TMP/SXT', 'TMP/SXT']","['Concentrations of CHI3L1, CRP, IL-18BP, IL-6, sICAM-1, and sTNFR2', 'relative risk of preterm birth', 'elevated concentrations of sTNFR2 and altered levels of IL-6', 'risk of malaria in pregnancy (MiP', 'sTNFR2, sICAM-1 and IL-18BP concentrations', 'risk of preterm birth']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C0041044', 'cui_str': 'sulfamethoxazole and trimethoprim'}]","[{'cui': 'C0041044', 'cui_str': 'sulfamethoxazole and trimethoprim'}, {'cui': 'C0040079', 'cui_str': 'Deoxythymidylic acid'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C1743775', 'cui_str': 'IL18BP protein, human'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0747820', 'cui_str': 'Malaria, antepartum'}]",,0.365901,"Concentrations of CHI3L1, CRP, IL-18BP, IL-6, sICAM-1, and sTNFR2 were quantified by ELISA in 1115 plasma samples collected over pregnancy from 326 women.","[{'ForeName': 'Chloe R', 'Initials': 'CR', 'LastName': 'McDonald', 'Affiliation': 'SAR Laboratories, Sandra Rotman Centre for Global Health, University Health Network-Toronto General Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'Andrea M', 'Initials': 'AM', 'LastName': 'Weckman', 'Affiliation': 'Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Andrea L', 'Initials': 'AL', 'LastName': 'Conroy', 'Affiliation': 'Department of Pediatrics, Indiana University, School of Medicine, Indianapolis, Indiana, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Olwoch', 'Affiliation': 'Makerere University-University of California, San Francisco Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Natureeba', 'Affiliation': 'Makerere University-University of California, San Francisco Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Moses R', 'Initials': 'MR', 'LastName': 'Kamya', 'Affiliation': 'Makerere University-University of California, San Francisco Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Diane V', 'Initials': 'DV', 'LastName': 'Havlir', 'Affiliation': 'Department of Medicine, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Grant', 'Initials': 'G', 'LastName': 'Dorsey', 'Affiliation': 'Department of Medicine, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Kevin C', 'Initials': 'KC', 'LastName': 'Kain', 'Affiliation': 'SAR Laboratories, Sandra Rotman Centre for Global Health, University Health Network-Toronto General Hospital, Toronto, Ontario, Canada. kevin.kain@uhn.ca.'}]",Scientific reports,['10.1038/s41598-019-43191-w']
2285,31063550,Opioid Use and Rate of Nicotine Metabolism Among Pregnant Smokers.,"INTRODUCTION


Smokers who use opioids smoke more cigarettes per day (CPD) than non-opioid users, which could be due to the effects of opioids on nicotine metabolism. Moreover, nicotine metabolism increases during pregnancy, potentially making quitting more difficult for pregnant smokers. We examined nicotine metabolism and its association with opioid use (OU) and CPD in pregnant smokers.
METHODS


We recruited pregnant women who smoked at least 5 CPD for a clinical trial of smoking cessation. Plasma nicotine metabolite ratio (NMR; trans-3'-hydroxycotinine (3HC)/cotinine)-a biomarker of nicotine metabolism-OU (involving methadone, buprenorphine, fentanyl, oxycodone, or tramadol), and CPD were assessed at baseline. We used linear regression to examine the associations between log-transformed NMR, OU, and CPD, adjusting for race/ethnicity and menthol smoking.
RESULTS


Among 129 pregnant smokers, 25 (19%) were opioid users; most were maintained on methadone (n = 14). Compared to non-OU smokers, OU smokers had higher median CPD (10.0 vs. 7.0, p = .0007), serum 3HC (81.0 vs. 42.0 ng/mL, p = .0001), and NMR (0.63 vs. 0.43, p < .0001). In addition, methadone-maintained smokers had a higher median NMR than non-OU smokers (0.66 vs. 0.43, p = .0004). Adjusting for covariates, log-transformed NMR was greater in OU smokers (p = .012), specifically methadone-maintained smokers (p = .024), than non-OU smokers.
CONCLUSIONS


Our preliminary results show that OU is associated with a higher NMR in pregnant smokers. A larger study sample is needed to replicate this finding, examine potential mechanisms, and determine its clinical significance.
IMPLICATIONS


Among pregnant smokers, we observed that nicotine metabolism was significantly faster among opioid users-the majority of whom were on methadone maintenance-compared to nonusers, which could have implications for smoking cessation. Further studies are needed to replicate this finding, evaluate potential mechanisms, and determine its clinical significance.",2020,"Compared to non-OU smokers, OU smokers had higher median CPD (10.0 vs. 7.0, p = .0007), serum 3HC (81.0 vs. 42.0 ng/mL, p = .0001), and NMR (0.63 vs. 0.43, p < .0001).","['pregnant women who smoked at least 5 CPD for a clinical trial of smoking cessation', '129 pregnant smokers, 25 (19%) were opioid users; most were maintained on methadone (n = 14', 'pregnant smokers', 'Pregnant Smokers', 'Smokers who use opioids smoke more cigarettes per day (CPD) than non-opioid users']","['methadone', ""trans-3'-hydroxycotinine (3HC)/cotinine)-a biomarker of nicotine metabolism-OU (involving methadone, buprenorphine, fentanyl, oxycodone, or tramadol"", 'opioid use (OU) and CPD']","['Opioid Use and Rate of Nicotine Metabolism', 'median CPD', 'serum 3HC', 'nicotine metabolism', 'Plasma nicotine metabolite ratio (NMR', 'NMR', 'median NMR']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C1520439', 'cui_str': '129 Strain Mouse'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]","[{'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C0063125', 'cui_str': 'Trans-3-hydroxycotinine'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0439505', 'cui_str': '/day'}]","[{'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0063125', 'cui_str': 'Trans-3-hydroxycotinine'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",129.0,0.0163935,"Compared to non-OU smokers, OU smokers had higher median CPD (10.0 vs. 7.0, p = .0007), serum 3HC (81.0 vs. 42.0 ng/mL, p = .0001), and NMR (0.63 vs. 0.43, p < .0001).","[{'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Oncken', 'Affiliation': 'Department of Medicine, University of Connecticut School of Medicine, Farmington, CT.'}, {'ForeName': 'Erin L', 'Initials': 'EL', 'LastName': 'Mead', 'Affiliation': 'Department of Medicine, University of Connecticut School of Medicine, Farmington, CT.'}, {'ForeName': 'Ellen A', 'Initials': 'EA', 'LastName': 'Dornelas', 'Affiliation': 'Division of Oncology, Department of Medicine, Hartford Hospital, Hartford, CT.'}, {'ForeName': 'Chia-Ling', 'Initials': 'CL', 'LastName': 'Kuo', 'Affiliation': 'Department of Medicine, University of Connecticut School of Medicine, Farmington, CT.'}, {'ForeName': 'Heather Z', 'Initials': 'HZ', 'LastName': 'Sankey', 'Affiliation': 'Department of Obstetrics and Gynecology, UMMS-Baystate, Springfield, MA.'}, {'ForeName': 'Henry R', 'Initials': 'HR', 'LastName': 'Kranzler', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania Perelman School of Medicine and Crescenz VAMC, Philadelphia, PA.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Thurlow', 'Affiliation': 'Department of Medicine, University of Connecticut School of Medicine, Farmington, CT.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz073']
2286,33098470,Clinical risk predictors in atrial fibrillation patients following successful coronary stenting: ENTRUST-AF PCI sub-analysis.,"AIMS


This subgroup analysis of the ENTRUST-AF PCI trial (ClinicalTrials.gov Identifier: NCT02866175; Date of registration: August 2016) evaluated type of AF, and CHA 2 DS 2 -VASc score parameters as predictors for clinical outcome.
METHODS


Patients were randomly assigned after percutaneous coronary intervention (PCI) to either edoxaban (60 mg/30 mg once daily [OD]; n = 751) plus a P2Y 12  inhibitor for 12 months or a vitamin K antagonist [VKA] (n = 755) plus a P2Y 12  inhibitor and aspirin (100 mg OD, for 1-12 months). The primary outcome was a composite of major/clinically relevant non-major bleeding (CRNM) within 12 months. The composite efficacy endpoint consisted of cardiovascular death, stroke, systemic embolic events, myocardial infarction (MI), and definite stent thrombosis.
RESULTS


Major/CRNM bleeding event rates were 20.7%/year and 25.6%/year with edoxaban and warfarin, respectively (HR [95% CI]: 0.83 [0.654-1.047]). The event rates of composite outcome were 7.26%/year and 6.86%/year, respectively (HR [95% CI]): 1.06 [0.711-1.587]), and of overall net clinical benefit were 12.48%/year and 12.80%/year, respectively (HR [(95% CI]: 0.99 [(0.730; 1.343]). Increasing CHA 2 DS 2 -VASc score was associated with increased rates of all outcomes. CHA 2 DS 2 -VASc score ≥ 5 was a marker for stent thrombosis. Paroxysmal AF was associated with a higher occurrence of MI (4.87% versus 2.01%, p = 0.0024).
CONCLUSION


After PCI in AF patients, increasing CHA 2 DS 2 -VASc score was associated with increased bleeding rates and CHA 2 DS 2 -VASc score (≥ 5) predicted the occurrence of stent thrombosis. Paroxysmal AF was associated with MI. These findings may have important clinical implications in AF patients.",2020,"Paroxysmal AF was associated with a higher occurrence of MI (4.87% versus 2.01%, p = 0.0024).
","['atrial fibrillation patients following successful coronary stenting', 'AF patients', 'Patients']","['mg once daily [OD]; n\u2009=\u2009751) plus a P2Y 12  inhibitor for 12\xa0months or a vitamin K antagonist [VKA] (n\u2009=\u2009755) plus a P2Y 12  inhibitor and aspirin', 'percutaneous coronary intervention (PCI) to either edoxaban', 'edoxaban']","['Major/CRNM bleeding event rates', 'composite of major/clinically relevant non-major bleeding (CRNM', 'bleeding rates and CHA 2 DS 2 -VASc score', 'CHA 2 DS 2 -VASc', 'overall net clinical benefit', 'Paroxysmal AF', 'cardiovascular death, stroke, systemic embolic events, myocardial infarction (MI), and definite stent thrombosis', 'event rates of composite outcome', 'occurrence of stent thrombosis', 'CHA 2 DS 2 -VASc score']","[{'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}]","[{'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C4517872', 'cui_str': '755'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C2975435', 'cui_str': 'edoxaban'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0574369', 'cui_str': 'Chamorro language'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0235480', 'cui_str': 'Paroxysmal atrial fibrillation'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0439544', 'cui_str': 'Definite'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}]",,0.313531,"Paroxysmal AF was associated with a higher occurrence of MI (4.87% versus 2.01%, p = 0.0024).
","[{'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Goette', 'Affiliation': 'Medizinische Klinik II: Kardiologie Und Intensivmedizin, St. Vincenz-Krankenhaus, Am Busdorf 2, 33098, Paderborn, Germany. andreas.goette@vincenz.de.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Eckardt', 'Affiliation': 'Atrial Fibrillation Network, Munster, Germany.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Valgimigli', 'Affiliation': 'Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Thorsten', 'Initials': 'T', 'LastName': 'Lewalter', 'Affiliation': 'Atrial Fibrillation Network, Munster, Germany.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Laeis', 'Affiliation': 'Daiichi Sankyo Europe, Munich, Germany.'}, {'ForeName': 'Paul-Egbert', 'Initials': 'PE', 'LastName': 'Reimitz', 'Affiliation': 'Daiichi Sankyo Europe, Munich, Germany.'}, {'ForeName': 'Rüdiger', 'Initials': 'R', 'LastName': 'Smolnik', 'Affiliation': 'Daiichi Sankyo Europe, Munich, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Zierhut', 'Affiliation': 'Daiichi Sankyo Europe, Munich, Germany.'}, {'ForeName': 'Jan G', 'Initials': 'JG', 'LastName': 'Tijssen', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Vranckx', 'Affiliation': 'Department of Cardiology and Intensive Care, Jessa Ziekenhuis, Faculty of Medicine and Life Sciences at the Hasselt University, Hasselt, Belgium.'}]",Clinical research in cardiology : official journal of the German Cardiac Society,['10.1007/s00392-020-01760-4']
2287,33098483,Healthy Choices Intervention is Associated with Reductions in Stigma Among Youth Living with HIV in the United States (ATN 129).,"Considering the lack of validated stigma reduction interventions for youth living with HIV (YLWH), we evaluated effects of the Healthy Choices intervention on HIV-related stigma among YLWH. We analyzed data from the Adolescent Medicine Trials Network protocol 129, multi-site randomized controlled trial, applying latent growth curve modeling with two linear slopes estimating changes in Berger's Stigma Scale pre-intervention, 16, 28, and 52 weeks post-intervention, as well as the trajectory of stigma scores over the follow-up period (N = 183). Expected value for the growth intercept was statistically significant (B intercept  = 2.53; 95% CI 2.32, 2.73; p < 0.001), as were differences in the change from baseline to 16-week follow-up (B intercept slope1  = - 0.02; 95% CI - 0.04, 0.01; p = 0.034). Expected value of the slope factor measuring growth over the follow-up period was non-significant suggesting that stigma scores were stable from 28 to 52 weeks. Our findings warrant replication and additional research comparing effects of this intervention to counterfactual controls.",2020,"Expected value for the growth intercept was statistically significant (B intercept  = 2.53; 95% CI 2.32, 2.73; p < 0.001), as were differences in the change from baseline to 16-week follow-up (B intercept slope1  = - 0.02; 95% CI - 0.04, 0.01; p = 0.034).","['youth living with HIV (YLWH', 'Youth Living with HIV in the United States (ATN 129']",[],['stigma scores'],"[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C4551504', 'cui_str': 'Tyrosinase-negative oculocutaneous albinism'}, {'cui': 'C1520439', 'cui_str': '129 Strain Mouse'}]",[],"[{'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.106599,"Expected value for the growth intercept was statistically significant (B intercept  = 2.53; 95% CI 2.32, 2.73; p < 0.001), as were differences in the change from baseline to 16-week follow-up (B intercept slope1  = - 0.02; 95% CI - 0.04, 0.01; p = 0.034).","[{'ForeName': 'Henna', 'Initials': 'H', 'LastName': 'Budhwani', 'Affiliation': 'Department of Health Care Organization and Policy, School of Public Health, University of Alabama at Birmingham (UAB), 330C Ryals Public Health Building, 1665 University Boulevard, Birmingham, AL, 35294, USA. budhwani@uab.edu.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Robles', 'Affiliation': 'School of Social Work, Rutgers University, New Brunswick, NJ, USA.'}, {'ForeName': 'Tyrel J', 'Initials': 'TJ', 'LastName': 'Starks', 'Affiliation': 'Department of Psychology, Hunter College of the City University of New York (CUNY), New York, NY, USA.'}, {'ForeName': 'Karen Kolmodin', 'Initials': 'KK', 'LastName': 'MacDonell', 'Affiliation': 'Department of Family Medicine and Public Health Sciences, School of Medicine, Wayne State University, Detroit, MI, USA.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Dinaj', 'Affiliation': 'Department of Family Medicine and Public Health Sciences, School of Medicine, Wayne State University, Detroit, MI, USA.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Naar', 'Affiliation': 'Center for Translational Behavioral Science, Florida State University College of Medicine, Tallahassee, FL, USA.'}]",AIDS and behavior,['10.1007/s10461-020-03071-1']
2288,33098548,"Long-Term Assessment of Lurasidone in Schizophrenia: Post Hoc Analysis of a 12-Month, Double Blind, Active-Controlled Trial and 6-Month Open-Label Extension Study.","INTRODUCTION


A post hoc analysis of a double-blind (DB) active control trial and an open-label extension (OLE) study was conducted to evaluate the long-term effects of lurasidone in patients with schizophrenia.
METHODS


In the DB trial, patients were randomised to receive lurasidone or risperidone for 12 months. In OLE, all patients received lurasidone for an additional 6 months. Treatment-emergent adverse events (TEAEs) were evaluated. Efficacy assessments included relapse rate (DB trial only), and Positive and Negative Syndrome Scale, Clinical Global Impression-Severity scale, and Montgomery-Åsberg Depression Rating Scale.
RESULTS


In the DB trial, patients with schizophrenia were randomised to lurasidone (n = 399) and risperidone (n = 190), of whom 129 and 84 continued into OLE, respectively. During the DB trial, incidence of TEAEs was similar for lurasidone (84.1%) and risperidone (84.2%). Lurasidone was associated with minimal changes in metabolic variables and prolactin levels, whereas risperidone was associated with clinically significant increases in prolactin and fasting glucose levels. The proportion of patients with metabolic syndrome was significantly lower in patients treated with lurasidone versus risperidone at the end of the DB trial (25.5% vs 40.4%; p = 0.0177). During OLE, patients switching from risperidone to lurasidone experienced a reduction in weight and prolactin levels; those continuing treatment with lurasidone experienced minimal changes in metabolic variables and prolactin. At the end of OLE, the proportion of patients with metabolic syndrome was no longer significantly different between groups (23.5% vs 31.5%; p = not significant). Efficacy outcomes were generally similar between groups during the DB trial, and were maintained during OLE.
CONCLUSION


Lurasidone was generally well tolerated and effective in clinically stable schizophrenia patients over the long term. Lurasidone was also generally well tolerated and maintained effectiveness over 6 months in patients switching from risperidone. Patients switching from risperidone experienced improvements in metabolic parameters and prolactin levels. These findings confirm lurasidone's long-term effectiveness and favourable metabolic profile in patients with schizophrenia.
TRIAL REGISTRATION


ClinicalTrials.gov identifier NCT00641745.",2020,"During the DB trial, incidence of TEAEs was similar for lurasidone (84.1%) and risperidone (84.2%).","['patients with schizophrenia', 'Schizophrenia']","['lurasidone', 'lurasidone or risperidone', 'lurasidone versus risperidone', 'Lurasidone', 'risperidone']","['weight and prolactin levels', 'metabolic parameters and prolactin levels', 'prolactin and fasting glucose levels', 'relapse rate (DB trial only), and Positive and Negative Syndrome Scale, Clinical Global Impression-Severity scale, and Montgomery-Åsberg Depression Rating Scale', 'metabolic variables and prolactin levels', 'metabolic variables and prolactin', 'tolerated and effective', 'Efficacy outcomes', 'tolerated and maintained effectiveness', 'proportion of patients with metabolic syndrome']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}]","[{'cui': 'C2003424', 'cui_str': 'lurasidone'}, {'cui': 'C0073393', 'cui_str': 'Risperidone'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0033371', 'cui_str': 'Prolactin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}]",,0.0410704,"During the DB trial, incidence of TEAEs was similar for lurasidone (84.1%) and risperidone (84.2%).","[{'ForeName': 'Preeya J', 'Initials': 'PJ', 'LastName': 'Patel', 'Affiliation': 'Sunovion Pharmaceuticals Europe Ltd, London, UK. Preeya.Patel@sunovion.com.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Weidenfeller', 'Affiliation': 'Sunovion Pharmaceuticals Europe Ltd, London, UK.'}, {'ForeName': 'Andrew P', 'Initials': 'AP', 'LastName': 'Jones', 'Affiliation': 'Sunovion Pharmaceuticals Europe Ltd, London, UK.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Nilsson', 'Affiliation': 'Sunovion Pharmaceuticals Europe Ltd, London, UK.'}, {'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Hsu', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Fort Lee, NJ, USA.'}]",Neurology and therapy,['10.1007/s40120-020-00221-4']
2289,31285357,Tight control for Crohn's disease with adalimumab-based treatment is cost-effective: an economic assessment of the CALM trial.,"OBJECTIVE


To evaluate the cost-effectiveness of an inflammatory biomarker and clinical symptom directed tight control strategy (TC) compared with symptom-based clinical management (CM) in patients with Crohn's disease (CD) naïve to immunosuppressants and biologics using a UK public payer perspective.
DESIGN


A regression model estimated weekly CD Activity Index (CDAI)-based transition matrices (remission: CDAI <150, moderate: CDAI ≥150 to <300, severe: CDAI ≥300 to <450, very severe: CDAI ≥450) based on the Effect of Tight Control Management on Crohn's Disease (CALM) trial. A regression predicted hospitalisations. Health utilities and costs were applied to health states. Work productivity was monetised and included in sensitivity analyses. Remission rate, CD-related hospitalisations, adalimumab injections, other direct medical costs, quality-adjusted life-years (QALYs) and incremental cost-effectiveness ratio (ICER) were calculated.
RESULTS


Over 48 weeks, TC was associated with a higher clinical remission (CDAI <150) rate (58.2% vs 46.8%), fewer CD-related hospitalisations (0.124 vs 0.297 events per patient) and more injections of adalimumab (40 mg sc) (mean 31.0 vs 24.7) than CM. TC was associated with 0.032 higher QALYs and £593 higher total medical costs. The ICER was £18 656 per QALY. The ICER was cost-effective in 57.9% of simulations. TC became dominant, meaning less costly but more effective, when work productivity was included.
CONCLUSION


A TC strategy as used in the CALM trial is cost-effective compared with CM. Incorporating costs related to work productivity increases the economic value of TC. Cross-national inferences from this analysis should be made with caution given differences in healthcare systems.
TRIAL REGISTRATION NUMBER


NCT01235689; Results.",2020,"Remission rate, CD-related hospitalisations, adalimumab injections, other direct medical costs, quality-adjusted life-years (QALYs) and incremental cost-effectiveness ratio (ICER) were calculated.
","[""patients with Crohn's disease (CD) naïve to immunosuppressants and biologics using a UK public payer perspective"", 'remission: CDAI <150, moderate: CDAI ≥150\u2009to <300, severe: CDAI ≥300\u2009to <450, very severe: CDAI ≥450', ""on Crohn's Disease (CALM) trial""]","['Tight Control Management', 'symptom-based clinical management (CM', 'adalimumab', 'inflammatory biomarker and clinical symptom directed tight control strategy (TC']","['cost-effectiveness', 'CD-related hospitalisations', 'CD Activity Index (CDAI)-based transition matrices', 'total medical costs', 'Work productivity', 'ICER', 'Remission rate, CD-related hospitalisations, adalimumab injections, other direct medical costs, quality-adjusted life-years (QALYs) and incremental cost-effectiveness ratio (ICER', 'clinical remission (CDAI <150) rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0021081', 'cui_str': 'Immunosuppressant agent'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0684321', 'cui_str': 'Regression - mental defense mechanism'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C3844104', 'cui_str': '450'}, {'cui': 'C3641272', 'cui_str': 'Very severe'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0439816', 'cui_str': 'Tightness sensation quality'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0439851', 'cui_str': 'Direct'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0451071', 'cui_str': ""Crohn's disease activity index""}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C4019255', 'cui_str': 'adalimumab Injection'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0684321', 'cui_str': 'Regression - mental defense mechanism'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C4321486', 'cui_str': '150'}]",,0.0418964,"Remission rate, CD-related hospitalisations, adalimumab injections, other direct medical costs, quality-adjusted life-years (QALYs) and incremental cost-effectiveness ratio (ICER) were calculated.
","[{'ForeName': 'Remo', 'Initials': 'R', 'LastName': 'Panaccione', 'Affiliation': 'Inflammatory Bowel Disease Unit, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Jean-Frederic', 'Initials': 'JF', 'LastName': 'Colombel', 'Affiliation': 'Division of Gastroenterology, Icahn School of Medicine Vanasek, Division of Gastroenterology and Hepatology, New York, New York, USA.'}, {'ForeName': 'Simon P L', 'Initials': 'SPL', 'LastName': 'Travis', 'Affiliation': 'Gastroenterology, John Radcliffe Hospital, Oxford, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bossuyt', 'Affiliation': 'Gastroenterology, Imelda General Hospital, Bonheiden, Belgium.'}, {'ForeName': 'Filip', 'Initials': 'F', 'LastName': 'Baert', 'Affiliation': 'Department of Gastroenterology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Tomáš', 'Initials': 'T', 'LastName': 'Vaňásek', 'Affiliation': 'Division of Gastroenterology and Hepatology, Hepato-Gastroenterologie HK, sro, Hradec Králové, Czech Republic.'}, {'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Danalıoğlu', 'Affiliation': 'Gastroenterology Department, Bezmialem Vakıf University, Istanbul, Turkey.'}, {'ForeName': 'Gottfried', 'Initials': 'G', 'LastName': 'Novacek', 'Affiliation': 'Department of Internal Medicine IV, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Armuzzi', 'Affiliation': 'Internal Medicine and Gastroenterology, Catholic University, Rome, Italy.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Reinisch', 'Affiliation': 'Department of Medicine IV, Medical University Vienna, Vienna, Austria.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Johnson', 'Affiliation': 'Medicus Economics LCC., Milton, Maine, USA.'}, {'ForeName': 'Marric', 'Initials': 'M', 'LastName': 'Buessing', 'Affiliation': 'Medicus Economics, Boston, Massachusetts, USA.'}, {'ForeName': 'Ezequiel', 'Initials': 'E', 'LastName': 'Neimark', 'Affiliation': 'AbbVie Inc., North Chicago, Illinois, USA.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Petersson', 'Affiliation': 'AbbVie Inc., North Chicago, Illinois, USA.'}, {'ForeName': 'Wan-Ju', 'Initials': 'WJ', 'LastName': 'Lee', 'Affiliation': 'AbbVie Inc., North Chicago, Illinois, USA.'}, {'ForeName': 'Geert R', 'Initials': 'GR', 'LastName': ""D'Haens"", 'Affiliation': 'Gastroenterology, AMC, Amsterdam, The Netherlands.'}]",Gut,['10.1136/gutjnl-2019-318256']
2290,31313243,The treatment with pasireotide in Cushing's disease: effect of long-term treatment on clinical picture and metabolic profile and management of adverse events in the experience of a single center.,"PURPOSES


Pasireotide is the first medical therapy officially approved for adult patients with Cushing's disease (CD) experiencing failure of pituitary surgery or not candidates for surgery. The current study aimed at investigating pasireotide effects on clinical picture and metabolic profile in patients enrolled in the phase III CSOM230B2305 trial at Naples center. In addition, the current study focused on safety issues encountered during the study, detailing the management of the different adverse events associated with the treatment with pasireotide in Naples center.
METHODS


Fourteen patients entered the study; eight patients, receiving pasireotide for at least 6 months, were considered for the efficacy analysis, whereas the entire cohort of 14 patients was considered for the safety analysis.
RESULTS


Full or partial disease control was obtained in 85.7% of patients, according to a ""per-protocol"" methodology analysis, and in 42.9% of patients, according to an ""intention-to-treat"" methodology analysis, after 12 months of treatment. A relevant improvement in clinical signs and symptoms, mainly in facial rubor, supraclavicular fat pad, bruising, hirsutism, and muscle strength was observed; body weight, body mass index, and waist circumference significantly reduced, and a slight non-significant reduction was observed in the prevalence of visceral obesity, hypercholesterolemia, and hypertriglyceridemia. Deterioration of glucose metabolism represented the most common adverse event, occurring in 71.4% of patients, and requiring a dietary regimen as first step, metformin therapy and/or long-acting insulin as second step, and short-acting insulin, as third step; no patients discontinued treatment for hyperglycaemia. Additional adverse events of interest were nausea (21.4%), and vomiting (14.3%), spontaneously resolved in few weeks or some months, except in one patient unsuccessfully treated with metoclopramide and ondansetron, and diarrhoea (14.3%), improved with loperamide treatment. Millimetric gallstones and biliary sludge (7.1%) were managed with ursodeoxycholic acid, inducing lithiasis and biliary sludge resolution, whereas hypocortisolism-related adverse events (7.1%) were resolved with a reduction in the pasireotide dose.
CONCLUSIONS


The current study on a limited series of patients contributes to confirm that pasireotide may be considered a valid option for treatment of patients with CD, although it requires an appropriate management of adverse events, especially hyperglycaemia.",2020,"Deterioration of glucose metabolism represented the most common adverse event, occurring in 71.4% of patients, and requiring a dietary regimen as first step, metformin therapy and/or long-acting insulin as second step, and short-acting insulin, as third step; no patients discontinued treatment for hyperglycaemia.","['patients enrolled in the phase III CSOM230B2305 trial at Naples center', 'Fourteen patients entered the study; eight patients, receiving pasireotide for at least 6\xa0months', ""adult patients with Cushing's disease (CD) experiencing failure of pituitary surgery or not candidates for surgery"", 'patients with CD']","['ursodeoxycholic acid', 'metoclopramide and ondansetron']","['diarrhoea', 'nausea', 'clinical signs and symptoms, mainly in facial rubor, supraclavicular fat pad, bruising, hirsutism, and muscle strength was observed; body weight, body mass index, and waist circumference', 'visceral obesity, hypercholesterolemia, and hypertriglyceridemia', 'vomiting', 'Deterioration of glucose metabolism', 'Millimetric gallstones and biliary sludge']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1872203', 'cui_str': 'pasireotide'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0221406', 'cui_str': 'Pituitary dependent hypercortisolism'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0032002', 'cui_str': 'Disorder of pituitary gland'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0042105', 'cui_str': 'ursodeoxycholic acid'}, {'cui': 'C0025853', 'cui_str': 'Metoclopramide'}, {'cui': 'C0061851', 'cui_str': 'Ondansetron'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0332575', 'cui_str': 'Red color'}, {'cui': 'C0589496', 'cui_str': 'Supraclavicular approach'}, {'cui': 'C0154270', 'cui_str': 'Localized adiposity'}, {'cui': 'C0009938', 'cui_str': 'Contusion'}, {'cui': 'C0019572', 'cui_str': 'Hirsutism'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C2936179', 'cui_str': 'Visceral Obesity'}, {'cui': 'C0020443', 'cui_str': 'Hypercholesterolemia'}, {'cui': 'C0020557', 'cui_str': 'Hypertriglyceridemia'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0008350', 'cui_str': 'Biliary calculus'}, {'cui': 'C0282074', 'cui_str': 'Biliary sludge'}]",14.0,0.0360174,"Deterioration of glucose metabolism represented the most common adverse event, occurring in 71.4% of patients, and requiring a dietary regimen as first step, metformin therapy and/or long-acting insulin as second step, and short-acting insulin, as third step; no patients discontinued treatment for hyperglycaemia.","[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Simeoli', 'Affiliation': 'Dipartimento di Medicina Clinica e Chirurgia, Sezione di Endocrinologia, Università ""Federico II"" di Napoli, Via Sergio Pansini 5, 80131, Naples, Italy.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Ferrigno', 'Affiliation': 'Dipartimento di Medicina Clinica e Chirurgia, Sezione di Endocrinologia, Università ""Federico II"" di Napoli, Via Sergio Pansini 5, 80131, Naples, Italy.'}, {'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'De Martino', 'Affiliation': 'Dipartimento di Medicina Clinica e Chirurgia, Sezione di Endocrinologia, Università ""Federico II"" di Napoli, Via Sergio Pansini 5, 80131, Naples, Italy.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Iacuaniello', 'Affiliation': 'Dipartimento di Medicina Clinica e Chirurgia, Sezione di Endocrinologia, Università ""Federico II"" di Napoli, Via Sergio Pansini 5, 80131, Naples, Italy.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Papa', 'Affiliation': 'Dipartimento di Medicina Clinica e Chirurgia, Sezione di Endocrinologia, Università ""Federico II"" di Napoli, Via Sergio Pansini 5, 80131, Naples, Italy.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Angellotti', 'Affiliation': 'Dipartimento di Medicina Clinica e Chirurgia, Sezione di Endocrinologia, Università ""Federico II"" di Napoli, Via Sergio Pansini 5, 80131, Naples, Italy.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Pivonello', 'Affiliation': 'Dipartimento di Medicina Clinica e Chirurgia, Sezione di Endocrinologia, Università ""Federico II"" di Napoli, Via Sergio Pansini 5, 80131, Naples, Italy.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Patalano', 'Affiliation': 'Dipartimento di Medicina Clinica e Chirurgia, Sezione di Endocrinologia, Università ""Federico II"" di Napoli, Via Sergio Pansini 5, 80131, Naples, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Negri', 'Affiliation': 'Dipartimento di Medicina Clinica e Chirurgia, Sezione di Endocrinologia, Università ""Federico II"" di Napoli, Via Sergio Pansini 5, 80131, Naples, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Colao', 'Affiliation': 'Dipartimento di Medicina Clinica e Chirurgia, Sezione di Endocrinologia, Università ""Federico II"" di Napoli, Via Sergio Pansini 5, 80131, Naples, Italy.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Pivonello', 'Affiliation': 'Dipartimento di Medicina Clinica e Chirurgia, Sezione di Endocrinologia, Università ""Federico II"" di Napoli, Via Sergio Pansini 5, 80131, Naples, Italy. rosario.pivonello@unina.it.'}]",Journal of endocrinological investigation,['10.1007/s40618-019-01077-8']
2291,31594895,Patient perspectives on hypertension management in health system of Sri Lanka: a qualitative study.,"INTRODUCTION


Uncontrolled hypertension is the leading risk factor for mortality globally, including low-income and middle-income countries (LMICs). However, pathways for seeking hypertension care and patients' experience with the utilisation of health services for hypertension in LMICs are not well understood.
OBJECTIVES


This study aimed to explore patients' perspectives on different dimensions of accessibility and availability of healthcare for the management of uncontrolled hypertension in Sri Lanka.
SETTING


Primary care in rural areas in Sri Lanka.
PARTICIPANTS


20 patients with hypertension were purposively sampled from an ongoing study of Control of Blood Pressure and Risk Attenuation in rural Bangladesh, Pakistan, Sri Lanka.
METHOD


We conducted in-depth interviews with patients. Interviews were audio-recorded and transcribed into local language (Sinhala) and translated to English. Thematic analysis was used and patient pathways on their experiences accessing care from government and private clinics are mapped out.
RESULTS


Overall, most patients alluded to the fact that their hypertension was diagnosed accidentally in an unrelated visit to a healthcare provider and revealed lack of adherence and consuming alternatives as barriers to control hypertension. Referring to the theme 'Accessibility and availability of hypertension care', patients complained of distance to the hospitals, long waiting time and shortage of medicine supplies at government clinics as the main barriers to accessing health services. They often resorted to private physicians and paid out of pocket when they experienced acute symptoms attributable to hypertension. Considering the theme 'Approachability and ability to perceive', the majority of patients mentioned increasing public awareness, training healthcare professionals for effective communication as areas of improvement. Under the theme 'Appropriateness and ability to engage', few patients were aware of the names or purpose of their medications and reportedly missed doses frequently. Reminders from family members were considered a major facilitator to adherence to antihypertensive medications. Patients welcomed the idea of outreach services for hypertension and health education closer to home in the theme 'Things the patients reported to improve the system'.
CONCLUSION


Patients identified several barriers to accessing hypertension care in Sri Lanka. Measures recommended improving hypertension management in Sri Lanka including public education on hypertension, better communication between healthcare professionals and patients, and efforts to improve access and understanding of antihypertensive medications.
TRIAL REGISTRATION NUMBER


NCT02657746.",2019,"Considering the theme 'Approachability and ability to perceive', the majority of patients mentioned increasing public awareness, training healthcare professionals for effective communication as areas of improvement.","['20 patients with hypertension were purposively sampled from an ongoing study of Control of Blood Pressure and Risk Attenuation in rural Bangladesh, Pakistan, Sri Lanka', 'Primary care in rural areas in Sri Lanka', 'health system of Sri Lanka']",[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}, {'cui': 'C0038088', 'cui_str': 'Sri Lanka'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]",[],[],20.0,0.0204242,"Considering the theme 'Approachability and ability to perceive', the majority of patients mentioned increasing public awareness, training healthcare professionals for effective communication as areas of improvement.","[{'ForeName': 'Manuja', 'Initials': 'M', 'LastName': 'Perera', 'Affiliation': 'Department of Public Health, University of Kelaniya Faculty of Medicine, Ragama, Sri Lanka.'}, {'ForeName': 'Chamini Kanatiwela', 'Initials': 'CK', 'LastName': 'de Silva', 'Affiliation': 'Clinical Trials Unit, Department of Pharmacology, University of Kelaniya Faculty of Medicine, Ragama, Sri Lanka.'}, {'ForeName': 'Saeideh', 'Initials': 'S', 'LastName': 'Tavajoh', 'Affiliation': 'Health Services and System Research, Duke-NUS Medical School, Singapore City, Singapore.'}, {'ForeName': 'Anuradhani', 'Initials': 'A', 'LastName': 'Kasturiratne', 'Affiliation': 'Department of Public Health, University of Kelaniya Faculty of Medicine, Ragama, Sri Lanka.'}, {'ForeName': 'Nathathasa Vihangi', 'Initials': 'NV', 'LastName': 'Luke', 'Affiliation': 'Clinical Trials Unit, Department of Pharmacology, University of Kelaniya Faculty of Medicine, Ragama, Sri Lanka.'}, {'ForeName': 'Dileepa Senajith', 'Initials': 'DS', 'LastName': 'Ediriweera', 'Affiliation': 'Centre for Health Informatics, Biostatistics and Epidemiology, University of Kelaniya Faculty of Medicine, Ragama, Sri Lanka.'}, {'ForeName': 'Channa D', 'Initials': 'CD', 'LastName': 'Ranasinha', 'Affiliation': 'Department of Pharmacology, Clinical Trials Unit, University of Kelaniya Faculty of Medicine, Ragama, Sri Lanka.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Legido-Quigley', 'Affiliation': 'Saw Swee Hock School of Public Health, NUS, Singapore city, Singapore.'}, {'ForeName': 'H Asita', 'Initials': 'HA', 'LastName': 'de Silva', 'Affiliation': 'Clinical Trials Unit, Department of Pharmacology, University of Kelaniya Faculty of Medicine, Ragama, Sri Lanka.'}, {'ForeName': 'Tazeen H', 'Initials': 'TH', 'LastName': 'Jafar', 'Affiliation': 'Health Services and System Research, Duke-NUS Medical School, Singapore City, Singapore tazeen.jafar@duke-nus.edu.sg.'}]",BMJ open,['10.1136/bmjopen-2019-031773']
2292,33098800,Effects of intensive versus standard blood pressure control on domain-specific cognitive function: a substudy of the SPRINT randomised controlled trial.,"BACKGROUND


Results from the Systolic Blood Pressure Intervention Trial (SPRINT) showed that intensive control of systolic blood pressure significantly reduced the occurrence of mild cognitive impairment, but not probable dementia. We investigated the effects of intensive lowering of systolic blood pressure on specific cognitive functions in a preplanned substudy of participants from SPRINT.
METHODS


SPRINT was an open-label, multicentre, randomised controlled trial undertaken at 102 sites, including academic medical centres, Veterans Affairs medical centres, hospitals, and independent clinics, in the USA and Puerto Rico. Participants were adults aged 50 years or older with systolic blood pressure higher than 130 mm Hg, but without diabetes, history of stroke, or dementia. Participants were randomly assigned (1:1) to a systolic blood pressure goal of less than 120 mm Hg (intensive treatment) versus less than 140 mm Hg (standard treatment). All major classes of antihypertensive agents were included. A subgroup of randomly assigned participants including, but not limited to, participants enrolled in an MRI substudy was then selected for a concurrent substudy of cognitive function (target 2800 participants). Each individual was assessed with a screening cognitive test battery and an extended cognitive test battery at baseline and biennially during the planned 4-year follow-up. The primary outcomes for this substudy were standardised composite scores for memory (Logical Memory I and II, Modified Rey-Osterrieth Complex Figure [immediate recall], and Hopkins Verbal Learning Test-Revised [delayed recall]) and processing speed (Trail Making Test and Digit Symbol Coding). SPRINT was registered with ClinicalTrials.gov, NCT01206062.
FINDINGS


From Nov 23, 2010, to Dec 28, 2012, 2921 participants (mean age 68·4 years [SD 8·6], 1080 [37%] women) who had been randomly assigned in SPRINT were enrolled in the substudy (1448 received intensive treatment and 1473 received standard treatment). SPRINT was terminated early due to benefit observed in the primary outcome (composite of cardiovascular events). After a median follow-up of 4·1 years (IQR 3·7-5·8), there was no between-group difference in memory, with an annual decline in mean standardised domain score of -0·005 (95% CI -0·010 to 0·001) in the intensive treatment group and -0·001 (-0·006 to 0·005) in the standard treatment group (between-group difference -0·004, 95% CI -0·012 to 0·004; p=0·33). Mean standardised processing speed domain scores declined more in the intensive treatment group (between-group difference -0·010, 95% CI -0·017 to -0·002; p=0·02), with an annual decline of -0·025 (-0·030 to -0·019) for the intensive treatment group and -0·015 (-0·021 to 0·009) for the standard treatment group.
INTERPRETATION


Intensive treatment to lower systolic blood pressure did not result in a clinically relevant difference compared with standard treatment in memory or processing speed in a subgroup of participants from SPRINT. The effect of blood pressure lowering might not be evident in specific domains of cognitive function, but instead distributed across multiple domains.
FUNDING


National Heart, Lung, and Blood Institute, National Institute of Diabetes and Digestive and Kidney Diseases, National Institute on Aging, National Institute of Neurological Disorders and Stroke, and the Alzheimer's Association.",2020,"Mean standardised processing speed domain scores declined more in the intensive treatment group (between-group difference -0·010, 95% CI -0·017 to -0·002; p=0·02), with an annual decline of -0·025 (-0·030 to -0·019) for the intensive treatment group and -0·015","['2921 participants (mean age 68·4 years [SD 8·6], 1080 [37%] women) who had been randomly assigned in SPRINT were enrolled in the substudy (1448 received intensive treatment and 1473 received standard treatment', 'Participants were adults aged 50 years or older with systolic blood pressure higher than 130 mm Hg, but without diabetes, history of stroke, or dementia', 'participants from SPRINT', '102 sites, including academic medical centres, Veterans Affairs medical centres, hospitals, and independent clinics, in the USA and Puerto Rico', 'participants enrolled in an MRI substudy was then selected for a concurrent substudy of cognitive function (target 2800 participants']","['systolic blood pressure goal of less than 120 mm Hg (intensive treatment', 'intensive lowering of systolic blood pressure', 'intensive versus standard blood pressure control']","['standardised composite scores for memory (Logical Memory I and II, Modified Rey-Osterrieth Complex Figure [immediate recall], and Hopkins Verbal Learning Test-Revised [delayed recall]) and processing speed (Trail Making Test and Digit Symbol Coding', 'Mean standardised processing speed domain scores', 'domain-specific cognitive function', 'systolic blood pressure']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C5192768', 'cui_str': '1080'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0034044', 'cui_str': 'Puerto Rico'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C4517680', 'cui_str': '2800'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4505408', 'cui_str': 'Rey-Osterrieth Complex Figure'}, {'cui': 'C0242393', 'cui_str': 'Immediate Recall'}, {'cui': 'C0042531', 'cui_str': 'Verbal learning'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0582591', 'cui_str': 'Processing speed'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}]",2921.0,0.271982,"Mean standardised processing speed domain scores declined more in the intensive treatment group (between-group difference -0·010, 95% CI -0·017 to -0·002; p=0·02), with an annual decline of -0·025 (-0·030 to -0·019) for the intensive treatment group and -0·015","[{'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Rapp', 'Affiliation': 'Department of Psychiatry and Behavioral Medicine, Wake Forest School of Medicine, Winston-Salem, NC, USA. Electronic address: srapp@wakehealth.edu.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Gaussoin', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Bonnie C', 'Initials': 'BC', 'LastName': 'Sachs', 'Affiliation': 'Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Chelune', 'Affiliation': 'Department of Neurology, University of Utah, School of Medicine, Salt Lake City, UT, USA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Supiano', 'Affiliation': 'Department of Internal Medicine, University of Utah, School of Medicine, Salt Lake City, UT, USA; Veterans Affairs Salt Lake City Health Care System, Salt Lake City, UT, USA.'}, {'ForeName': 'Alan J', 'Initials': 'AJ', 'LastName': 'Lerner', 'Affiliation': 'Department of Neurology, Case Western Reserve University School of Medicine, Cleveland, OH, USA.'}, {'ForeName': 'Virginia G', 'Initials': 'VG', 'LastName': 'Wadley', 'Affiliation': 'Department of Medicine, University of Alabama, Birmingham, AL, USA.'}, {'ForeName': 'Valarie M', 'Initials': 'VM', 'LastName': 'Wilson', 'Affiliation': 'Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Lawrence J', 'Initials': 'LJ', 'LastName': 'Fine', 'Affiliation': 'Clinical Applications and Prevention Branch, National Heart, Lung, and Blood Institute, Bethesda, MD, USA.'}, {'ForeName': 'Jeff C', 'Initials': 'JC', 'LastName': 'Whittle', 'Affiliation': 'Department of Medicine, Medical College of Wisconsin, Milwaukee, WI, USA; Clement J Zablocki Veterans Affairs Medical Center, Milwaukee, WI, USA.'}, {'ForeName': 'Alexander P', 'Initials': 'AP', 'LastName': 'Auchus', 'Affiliation': 'Department of Neurology, University of Mississippi Medical Center, Jackson, MS, USA.'}, {'ForeName': 'Srinivasan', 'Initials': 'S', 'LastName': 'Beddhu', 'Affiliation': 'Department of Internal Medicine, University of Utah, School of Medicine, Salt Lake City, UT, USA; Veterans Affairs Salt Lake City Health Care System, Salt Lake City, UT, USA.'}, {'ForeName': 'Dan R', 'Initials': 'DR', 'LastName': 'Berlowitz', 'Affiliation': 'Bedford Veterans Affairs Medical Center, Bedford, MA, USA; Department of Public Health, University of Massachusetts Lowell, Lowell, MA, USA.'}, {'ForeName': 'Adam P', 'Initials': 'AP', 'LastName': 'Bress', 'Affiliation': 'Department of Population Health Sciences, University of Utah, School of Medicine, Salt Lake City, UT, USA.'}, {'ForeName': 'Karen C', 'Initials': 'KC', 'LastName': 'Johnson', 'Affiliation': 'Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, TN, USA.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Krousel-Wood', 'Affiliation': 'Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, TN, USA; Department of Medicine, Tulane University, New Orleans, LA, USA; Department of Epidemiology, Tulane University, New Orleans, LA, USA; Ochsner Health System, New Orleans, LA, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Martindale-Adams', 'Affiliation': 'Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, TN, USA.'}, {'ForeName': 'Eliza C', 'Initials': 'EC', 'LastName': 'Miller', 'Affiliation': 'Department of Neurology, College of Physicians and Surgeons, Columbia University, New York, NY, USA.'}, {'ForeName': 'Dena E', 'Initials': 'DE', 'LastName': 'Rifkin', 'Affiliation': 'Division of Nephrology-Hypertension, University of California San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Joni K', 'Initials': 'JK', 'LastName': 'Snyder', 'Affiliation': 'Clinical Applications and Prevention Branch, National Heart, Lung, and Blood Institute, Bethesda, MD, USA.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Tamariz', 'Affiliation': 'Miami Veterans Affairs Healthcare System, Miami, FL, USA; Division of Population Health and Computational Medicine, University of Miami, Miami, FL, USA.'}, {'ForeName': 'Dawn F', 'Initials': 'DF', 'LastName': 'Wolfgram', 'Affiliation': 'Department of Medicine, Medical College of Wisconsin, Milwaukee, WI, USA; Clement J Zablocki Veterans Affairs Medical Center, Milwaukee, WI, USA.'}, {'ForeName': 'Maryjo L', 'Initials': 'ML', 'LastName': 'Cleveland', 'Affiliation': 'Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Mia', 'Initials': 'M', 'LastName': 'Yang', 'Affiliation': 'Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Linda O', 'Initials': 'LO', 'LastName': 'Nichols', 'Affiliation': 'Preventive Medicine Section, Veterans Affairs Medical Center, Memphis, TN, USA.'}, {'ForeName': 'Robert Nick', 'Initials': 'RN', 'LastName': 'Bryan', 'Affiliation': 'Department of Diagnostic Medicine, Dell Medical School, University of Texas, Austin, TX, USA.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Reboussin', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Jeff D', 'Initials': 'JD', 'LastName': 'Williamson', 'Affiliation': 'Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Nicholas M', 'Initials': 'NM', 'LastName': 'Pajewski', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Neurology,['10.1016/S1474-4422(20)30319-7']
2293,33098852,"Ethinyl Estradiol vs Estradiol Valerate in Combined Oral Contraceptives - Effect on Glucose Tolerance: A Randomized, Controlled Clinical Trial.","OBJECTIVE


To compare the effects of two formulations of combined oral contraceptives (COCs), estradiol valerate (EV) and ethinyl estradiol (EE) combined with dienogest (DNG), and DNG-only, on glucose tolerance. Study Design We performed a randomized, controlled 9-week clinical trial. Inclusion criteria were: age 18-35 years, regular menstrual cycle (28±7 days), no polycystic ovaries, non-smoking, no contraindications for COC use and a 2-month wash-out from hormonal contraceptive use. The women were randomized to EV+DNG (n=20), EE+DNG (n=20), and DNG-only (n=19), and evaluated at baseline, at 4-5 weeks and 8-9 weeks of treatment. Study medications were used continuously for 63 days. Primary outcome measure was change in the whole-body insulin sensitivity index (Matsuda index) derived from the oral glucose tolerance test (OGTT) over the treatment period. Secondary outcome measures were area under curves (AUC) of glucose and insulin, homeostatic model assessment - insulin resistance (HOMA-IR) and Insulin Sensitivity Index (ISI).
RESULTS


Fifty-nine women enrolled, and 56 women completed the study. The Matsuda index changed from baseline as follows (mean percentage change, mean change [95%CI]): DNG-only -12%, -1.45 [95%CI -3.22-0.325] P=0.10; EV+DNG +2.7%, -0.10 [-1.34-1.14] P=0.86; EE+DNG -5.5%, -1.02 [-2.51-0.46] P=0.16, comparing the groups P=0.27. There were no clinically significant differences in glucose tolerance between the COC groups, but the DNG-only group showed an improvement in the 2-hour glucose levels (5.5 [95%CI 5.0-6.0] to 4.7 mmol/l [4.2-5.2], P=0.001).
CONCLUSION


We found no clinically significant differences between EV and EE combined with DNG and DNG-only on glucose tolerance in healthy, young, normal-weight women, indicating that these preparations appear close to neutral regarding glucose metabolism when used continuously for nine weeks. Trial registration number EU Clinical trials register, EudraCT 2014-001243-20; ClinicalTrials.gov, NCT02352090. Implications Combinations of both ethinyl estradiol and natural estradiol (estradiol valerate) with dienogest (DNG), as well as DNG-only, seem metabolically safe in young and healthy women in short-term continuous use.",2020,"We found no clinically significant differences between EV and EE combined with DNG and DNG-only on glucose tolerance in healthy, young, normal-weight women, indicating that these preparations appear close to neutral regarding glucose metabolism when used continuously for nine weeks.","['Inclusion criteria were: age 18-35 years, regular menstrual cycle (28±7 days), no polycystic ovaries, non-smoking, no contraindications for COC use and a 2-month wash-out from hormonal contraceptive use', 'young and healthy women in short-term continuous use', 'Fifty-nine women enrolled, and 56 women completed the study', 'healthy, young, normal-weight women']","['ethinyl estradiol and natural estradiol (estradiol valerate) with dienogest (DNG', 'Ethinyl Estradiol vs Estradiol Valerate', 'EV+DNG', 'combined oral contraceptives (COCs), estradiol valerate (EV) and ethinyl estradiol (EE) combined with dienogest (DNG), and DNG']","['change in the whole-body insulin sensitivity index (Matsuda index', 'area under curves (AUC) of glucose and insulin, homeostatic model assessment - insulin resistance (HOMA-IR) and Insulin Sensitivity Index (ISI', '2-hour glucose levels', 'oral glucose tolerance test (OGTT', 'glucose tolerance', 'Glucose Tolerance', 'Matsuda index']","[{'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0025329', 'cui_str': 'Normal menstrual cycle'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C3830128', 'cui_str': '59'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C2712185', 'cui_str': 'Normal weight'}]","[{'cui': 'C0015011', 'cui_str': 'Ethinyl Estradiol'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0059623', 'cui_str': 'Estradiol valerate'}, {'cui': 'C0057916', 'cui_str': 'dienogest'}, {'cui': 'C0009906', 'cui_str': 'Oral Contraceptives, Combined'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C1292425', 'cui_str': '2 hours'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}]",59.0,0.12365,"We found no clinically significant differences between EV and EE combined with DNG and DNG-only on glucose tolerance in healthy, young, normal-weight women, indicating that these preparations appear close to neutral regarding glucose metabolism when used continuously for nine weeks.","[{'ForeName': 'Annina', 'Initials': 'A', 'LastName': 'Haverinen', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Helsinki and Helsinki University Hospital, Haartmaninkatu 2, PO 140, 00029 Helsinki, Finland.'}, {'ForeName': 'Marika', 'Initials': 'M', 'LastName': 'Kangasniemi', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Oulu, Oulu University Hospital and Medical Research Centre PEDEGO Research Unit, Kajaanintie 50, PO 5000, 90014 Oulu, Finland.'}, {'ForeName': 'Kaisu', 'Initials': 'K', 'LastName': 'Luiro', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Helsinki and Helsinki University Hospital, Haartmaninkatu 2, PO 140, 00029 Helsinki, Finland.'}, {'ForeName': 'Terhi', 'Initials': 'T', 'LastName': 'Piltonen', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Oulu, Oulu University Hospital and Medical Research Centre PEDEGO Research Unit, Kajaanintie 50, PO 5000, 90014 Oulu, Finland.'}, {'ForeName': 'Oskari', 'Initials': 'O', 'LastName': 'Heikinheimo', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Helsinki and Helsinki University Hospital, Haartmaninkatu 2, PO 140, 00029 Helsinki, Finland.'}, {'ForeName': 'Juha S', 'Initials': 'JS', 'LastName': 'Tapanainen', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Helsinki and Helsinki University Hospital, Haartmaninkatu 2, PO 140, 00029 Helsinki, Finland; Department of Obstetrics and Gynecology, University of Oulu, Oulu University Hospital and Medical Research Centre PEDEGO Research Unit, Kajaanintie 50, PO 5000, 90014 Oulu, Finland. Electronic address: juha.tapanainen@helsinki.fi.'}]",Contraception,['10.1016/j.contraception.2020.10.014']
2294,33098856,"Oral once-daily berotralstat for the prevention of hereditary angioedema attacks: a randomized, double-blind, placebo-controlled phase 3 trial.","BACKGROUND


Berotralstat (BCX7353) is an oral, once-daily inhibitor of plasma kallikrein in development for the prophylaxis of hereditary angioedema (HAE) attacks.
OBJECTIVE


To determine the efficacy, safety, and tolerability of berotralstat in patients with HAE over a 24-week treatment period (the phase 3 APeX-2 trial).
METHODS


APeX-2 was a double-blind, parallel-group study that randomized patients at 40 sites in 11 countries 1:1:1 to once-daily berotralstat 110 mg, 150 mg, or placebo (Clinicaltrials.gov, NCT03485911). Patients aged ≥12 years with HAE due to C1 inhibitor deficiency and ≥2 investigator-confirmed HAE attacks in the first 56 days of a prospective run-in period were eligible. The primary efficacy endpoint was the rate of investigator-confirmed HAE attacks during the 24-week treatment period.
RESULTS


One-hundred twenty-one patients were randomized, and 120 received ≥1 dose of study drug (N=41, 40, and 39 for the berotralstat 110-mg, 150-mg, and placebo groups, respectively). Berotralstat demonstrated a significant reduction in attack rate at both 110 mg (1.65 attacks/month; p=0.024) and 150 mg (1.31 attacks/month; p<0.001) relative to placebo (2.35 attacks/month). The most frequent treatment-emergent adverse events (TEAEs) that occurred more with berotralstat than placebo were abdominal pain, vomiting, diarrhea, and back pain. No drug-related serious TEAEs occurred.
CONCLUSION


Both the 110-mg and 150-mg doses of berotralstat reduced HAE attack rates compared with placebo and were safe and generally well tolerated. The most favorable benefit-to-risk profile was observed at a dose of 150 mg/day.",2020,Both the 110-mg and 150-mg doses of berotralstat reduced HAE attack rates compared with placebo and were safe and generally well tolerated.,"['hereditary angioedema attacks', 'Patients aged ≥12 years with HAE due to C1 inhibitor deficiency and ≥2 investigator-confirmed HAE attacks in the first 56 days of a prospective run-in period were eligible', 'One-hundred twenty-one patients', 'patients with HAE over a 24-week treatment period (the phase 3 APeX-2 trial']","['Berotralstat (BCX7353', 'placebo']","['efficacy, safety, and tolerability of berotralstat', 'abdominal pain, vomiting, diarrhea, and back pain', 'HAE attack rates', 'rate of investigator-confirmed HAE attacks', 'attack rate', 'tolerated']","[{'cui': 'C3854637', 'cui_str': 'Hereditary angioedema attack'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019243', 'cui_str': 'Hereditary angioedema'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0140145', 'cui_str': 'APEX1 protein, human'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C3854637', 'cui_str': 'Hereditary angioedema attack'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0004063', 'cui_str': 'Assault'}]",121.0,0.513008,Both the 110-mg and 150-mg doses of berotralstat reduced HAE attack rates compared with placebo and were safe and generally well tolerated.,"[{'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Zuraw', 'Affiliation': 'University of California San Diego, San Diego, CA, USA.'}, {'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Lumry', 'Affiliation': 'Allergy & Asthma Specialists of Dallas, Dallas, TX, USA.'}, {'ForeName': 'Douglas T', 'Initials': 'DT', 'LastName': 'Johnston', 'Affiliation': 'Asthma & Allergy Specialists, Charlotte, NC, USA.'}, {'ForeName': 'Emel', 'Initials': 'E', 'LastName': 'Aygören-Pürsün', 'Affiliation': 'University Hospital Frankfurt, Goethe University Frankfurt, Germany.'}, {'ForeName': 'Aleena', 'Initials': 'A', 'LastName': 'Banerji', 'Affiliation': 'Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Jonathan A', 'Initials': 'JA', 'LastName': 'Bernstein', 'Affiliation': 'University of Cincinnati, Cincinnati, OH, USA.'}, {'ForeName': 'Sandra C', 'Initials': 'SC', 'LastName': 'Christiansen', 'Affiliation': 'University of California San Diego, San Diego, CA, USA.'}, {'ForeName': 'Joshua S', 'Initials': 'JS', 'LastName': 'Jacobs', 'Affiliation': 'Allergy & Asthma Clinical Research, Walnut Creek, CA, USA.'}, {'ForeName': 'Karl V', 'Initials': 'KV', 'LastName': 'Sitz', 'Affiliation': 'Little Rock Allergy & Asthma Clinical Research Center, Little Rock, AR, USA.'}, {'ForeName': 'Richard G', 'Initials': 'RG', 'LastName': 'Gower', 'Affiliation': 'University of Washington School of Medicine, Marycliff Clinical Research, Spokane, WA, USA.'}, {'ForeName': 'Remi', 'Initials': 'R', 'LastName': 'Gagnon', 'Affiliation': 'Clinique Spécialisée en Allergie de la Capitale, Québec, Canada.'}, {'ForeName': 'H James', 'Initials': 'HJ', 'LastName': 'Wedner', 'Affiliation': 'Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Tamar', 'Initials': 'T', 'LastName': 'Kinaciyan', 'Affiliation': 'Medical University of Vienna, Department of Dermatology, Vienna, Austria.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Hakl', 'Affiliation': ""Department of Clinical Immunology and Allergology, St. Anne's University Hospital in Brno and Faculty of Medicine, Masaryk University, Brno, Czech Republic.""}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Hanzlíková', 'Affiliation': 'Faculty Hospital; Department of Allergology and Immunology, Plzen, Czech Republic.'}, {'ForeName': 'John T', 'Initials': 'JT', 'LastName': 'Anderson', 'Affiliation': 'Clinical Research Center of Alabama, Birmingham, AL, USA.'}, {'ForeName': 'Donald L', 'Initials': 'DL', 'LastName': 'McNeil', 'Affiliation': 'Optimed Research Ltd, Columbus, OH, USA.'}, {'ForeName': 'Stephen B', 'Initials': 'SB', 'LastName': 'Fritz', 'Affiliation': 'Portland Clinical Research, Portland, OR, USA.'}, {'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Yang', 'Affiliation': 'Ottawa Allergy Research Corporation, Department of Medicine, University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'Raffi', 'Initials': 'R', 'LastName': 'Tachdjian', 'Affiliation': 'Department of Pediatrics, University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Paula J', 'Initials': 'PJ', 'LastName': 'Busse', 'Affiliation': 'Division of Clinical Immunology and Allergy, Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Craig', 'Affiliation': 'Department of Medicine and Pediatrics, Penn State University, Hershey, PA, USA.'}, {'ForeName': 'H Henry', 'Initials': 'HH', 'LastName': 'Li', 'Affiliation': 'Institute for Asthma and Allergy, Chevy Chase, Maryland.'}, {'ForeName': 'Henriette', 'Initials': 'H', 'LastName': 'Farkas', 'Affiliation': 'Hungarian Angioedema Reference Center, Third Department of Internal Medicine, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Jessica M', 'Initials': 'JM', 'LastName': 'Best', 'Affiliation': 'BioCryst Pharmaceuticals, Durham, NC, USA.'}, {'ForeName': 'Desiree', 'Initials': 'D', 'LastName': 'Clemons', 'Affiliation': 'BioCryst Pharmaceuticals, Durham, NC, USA.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Cornpropst', 'Affiliation': 'BioCryst Pharmaceuticals, Durham, NC, USA.'}, {'ForeName': 'Sylvia M', 'Initials': 'SM', 'LastName': 'Dobo', 'Affiliation': 'BioCryst Pharmaceuticals, Durham, NC, USA.'}, {'ForeName': 'Heather A', 'Initials': 'HA', 'LastName': 'Iocca', 'Affiliation': 'BioCryst Pharmaceuticals, Durham, NC, USA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Kargl', 'Affiliation': 'BioCryst Pharmaceuticals, Durham, NC, USA.'}, {'ForeName': 'Eniko', 'Initials': 'E', 'LastName': 'Nagy', 'Affiliation': 'BioCryst Pharmaceuticals, Durham, NC, USA.'}, {'ForeName': 'Sharon C', 'Initials': 'SC', 'LastName': 'Murray', 'Affiliation': 'BioCryst Pharmaceuticals, Durham, NC, USA.'}, {'ForeName': 'Phil', 'Initials': 'P', 'LastName': 'Collis', 'Affiliation': 'BioCryst Pharmaceuticals, Durham, NC, USA.'}, {'ForeName': 'William P', 'Initials': 'WP', 'LastName': 'Sheridan', 'Affiliation': 'BioCryst Pharmaceuticals, Durham, NC, USA. Electronic address: bsheridan@biocryst.com.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Maurer', 'Affiliation': 'Dermatological Allergology, Department of Dermatology and Allergy, Charité Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Marc A', 'Initials': 'MA', 'LastName': 'Riedl', 'Affiliation': 'University of California San Diego, San Diego, CA, USA.'}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2020.10.015']
2295,33098862,Letter to the editor: Management of Bladder Bowel Dysfunction in Children by Pelvic Floor Interferential Electrical Stimulation and Muscle Exercises: A Randomized Clinical Trial.,,2020,,['Children by'],['Pelvic Floor Interferential Electrical Stimulation and Muscle Exercises'],[],"[{'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",[],,0.0429551,,"[{'ForeName': 'Vesna D', 'Initials': 'VD', 'LastName': 'Zivkovic', 'Affiliation': 'University of Nis Faculty of Medicine, Clinic of Physical Medicine and Rehabilitation, Clinical Centre Nis, Nis. Electronic address: petvesna67@gmail.com.'}, {'ForeName': 'Ivona', 'Initials': 'I', 'LastName': 'Stankovic', 'Affiliation': 'University of Nis Faculty of Medicine, Clinic of Physical Medicine and Rehabilitation, Clinical Centre Nis, Nis.'}, {'ForeName': 'Lidija', 'Initials': 'L', 'LastName': 'Dimitrijevic', 'Affiliation': 'University of Nis Faculty of Medicine, Clinic of Physical Medicine and Rehabilitation, Clinical Centre Nis, Nis.'}, {'ForeName': 'Dragan', 'Initials': 'D', 'LastName': 'Zlatanovic', 'Affiliation': 'University of Nis Faculty of Medicine, Clinic of Physical Medicine and Rehabilitation, Clinical Centre Nis, Nis.'}, {'ForeName': 'Natasa', 'Initials': 'N', 'LastName': 'Savic', 'Affiliation': 'College of Health Studies Cuprija, Cuprija, Serbia.'}]",Urology,['10.1016/j.urology.2020.10.012']
2296,33098889,Post-obturation pain associated with tricalcium silicate and resin-based sealer techniques - a randomized clinical trial.,"INTRODUCTION


Incidence of immediate post-obturation pain associated with 2 sealer techniques was compared and potential prognostic factors identified.
METHODS


Patients referred for endodontic treatment were recruited with informed consent. Root canals were debrided and teeth rendered asymptomatic before random allocation to receive TotalFill® BC (FKG Dentaire SA) or AH plus® (Dentsply Maillefer) sealer. Patients blinded to the sealer reported post-obturation pain experience at 1 day, 3 days and 7 days after treatment. Blinded and calibrated assessors independently reviewed treatment quality, sealer extrusion and radiographic data under standardised conditions.
RESULTS


One hundred and sixty eligible patients (163 teeth, 95.3%) returned their pain diary. No post-obturation pain difference was found between the 2 sealers (p>0.05) although AH plus® sealer technique was significantly associated with extrusion beyond the apex (p<0.05, OR=3.02, 95% CI=1.39-6.57). Thirty-three (20.6%) patients reported pain at Day 1 (median 1=very mild pain); 16 (10.0%) at Day 3 (median 1=very mild pain); 9 patients (5.6%) at Day 7 (median 2=mild pain). Prognostic factors: (i) moderate/severe preoperative pain (OR=4.41, 95% CI=1.42-13.76 at Day 3; OR=5.16, 95%CI=1.17-22.78 at Day 7), (ii) provoked preoperative pain (OR=4.24, 95% CI=1.40-12.78 at Day 3; OR=5.35, 95%CI=1.27-22.51 at Day 7), (iii) pulpless tooth (OR=0.11, 95% CI=0.02-0.57 at Day 3), (iv) sonic activation during treatment (OR=3.02, 95% CI=1.39-6.57 at Day 1; OR=3.01, 95%CI=1.05-8.59 at Day 3).
CONCLUSION


There was no significant difference in pain experience between teeth filled using AH Plus® or TotalFill® BC sealer 1, 3 and 7 days after obturation. Patient and treatment-related factors could influence post-obturation pain.",2020,"There was no significant difference in pain experience between teeth filled using AH Plus® or TotalFill® BC sealer 1, 3 and 7 days after obturation.","['Patients referred for endodontic treatment were recruited with informed consent', 'One hundred and sixty eligible patients (163 teeth, 95.3%) returned their pain diary']","['tricalcium silicate and resin-based sealer techniques', 'TotalFill® BC (FKG Dentaire SA) or AH plus® (Dentsply Maillefer) sealer']","['Prognostic factors: (i) moderate/severe preoperative pain', 'No post-obturation pain difference', 'preoperative pain', 'pain experience', 'pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0700632', 'cui_str': 'Endodontic procedure'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0451366', 'cui_str': 'Pain diary'}]","[{'cui': 'C1668343', 'cui_str': 'tricalcium silicate'}, {'cui': 'C0035191', 'cui_str': 'Resins, Plant'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0449942', 'cui_str': 'Sealer'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0673096', 'cui_str': 'AH Plus'}, {'cui': 'C0112984', 'cui_str': 'Dentsply'}]","[{'cui': 'C1514474', 'cui_str': 'Prognostic Factors'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]",160.0,0.191884,"There was no significant difference in pain experience between teeth filled using AH Plus® or TotalFill® BC sealer 1, 3 and 7 days after obturation.","[{'ForeName': 'Tan Heng', 'Initials': 'TH', 'LastName': 'Seh Gabriel', 'Affiliation': 'Faculty of Dentistry, National University of Singapore, Singapore.'}, {'ForeName': 'Lim Kian', 'Initials': 'LK', 'LastName': 'Chong', 'Affiliation': 'Faculty of Dentistry, National University of Singapore, Singapore.'}, {'ForeName': 'Lui Jeen', 'Initials': 'LJ', 'LastName': 'Nee', 'Affiliation': 'Department of Restorative Dentistry, National Dental Centre of Singapore.'}, {'ForeName': 'Lai Wei', 'Initials': 'LW', 'LastName': 'Ming Clement', 'Affiliation': 'Faculty of Dentistry, National University of Singapore, Singapore.'}, {'ForeName': 'Victoria Soo', 'Initials': 'VS', 'LastName': 'Hoon Yu', 'Affiliation': 'Faculty of Dentistry, National University of Singapore, Singapore. Electronic address: denyshv@nus.edu.sg.'}]",Journal of endodontics,['10.1016/j.joen.2020.10.013']
2297,33099278,Prevention and treatment of pulmonary congestion in patients undergoing venoarterial extracorporeal membrane oxygenation for cardiogenic shock.,"Cardiogenic shock is still a major driver of mortality on intensive care units and complicates ∼10% of acute coronary syndromes with contemporary mortality rates up to 50%. In the meantime, percutaneous circulatory support devices, in particular venoarterial extracorporeal membrane oxygenation (VA-ECMO), have emerged as an established salvage intervention for patients in cardiogenic shock. Venoarterial extracorporeal membrane oxygenation provides temporary circulatory support until other treatments are effective and enables recovery or serves as a bridge to ventricular assist devices, heart transplantation, or decision-making. In this critical care perspective, we provide a concise overview of VA-ECMO utilization in cardiogenic shock, considering rationale, critical care management, as well as weaning aspects. We supplement previous literature by focusing on therapeutic issues related to the vicious circle of retrograde aortic VA-ECMO flow, increased left ventricular (LV) afterload, insufficient LV unloading, and severe pulmonary congestion limiting prognosis in a relevant proportion of patients receiving VA-ECMO treatment. We will outline different modifications in percutaneous mechanical circulatory support to meet this challenge. Besides a strategy of running ECMO at lowest possible flow rates, novel therapeutic options including the combination of VA-ECMO with percutaneous microaxial pumps or implementation of a venoarteriovenous-ECMO configuration based on an additional venous cannula supplying towards pulmonary circulation are most promising among LV unloading and venting strategies. The latter may even combine the advantages of venovenous and venoarterial ECMO therapy, providing potent respiratory and circulatory support at the same time. However, whether VA-ECMO can reduce mortality has to be evaluated in the urgently needed, ongoing prospective randomized studies EURO-SHOCK (NCT03813134), ANCHOR (NCT04184635), and ECLS-SHOCK (NCT03637205). These studies will provide the opportunity to investigate indication, mode, and effect of LV unloading in dedicated sub-analyses. In future, the Heart Teams should aim at conducting a dedicated randomized trial comparing VA-ECMO support with vs. without LV unloading strategies in patients with cardiogenic shock.",2020,"Venoarterial extracorporeal membrane oxygenation provides temporary circulatory support until other treatments are effective and enables recovery or serves as a bridge to ventricular assist devices, heart transplantation, or decision-making.","['patients in cardiogenic shock', 'patients with cardiogenic shock', 'patients undergoing venoarterial extracorporeal membrane oxygenation for cardiogenic shock']","['venovenous and venoarterial ECMO therapy', 'Venoarterial extracorporeal membrane oxygenation', 'VA-ECMO']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036980', 'cui_str': 'Cardiogenic shock'}, {'cui': 'C5192097', 'cui_str': 'Venoarterial extracorporeal membrane oxygenation'}]","[{'cui': 'C0391895', 'cui_str': 'Venovenous'}, {'cui': 'C0450124', 'cui_str': 'Venoarterial'}, {'cui': 'C0015357', 'cui_str': 'Extracorporeal membrane oxygenation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C5192097', 'cui_str': 'Venoarterial extracorporeal membrane oxygenation'}]",[],,0.0966445,"Venoarterial extracorporeal membrane oxygenation provides temporary circulatory support until other treatments are effective and enables recovery or serves as a bridge to ventricular assist devices, heart transplantation, or decision-making.","[{'ForeName': 'Enzo', 'Initials': 'E', 'LastName': 'Lüsebrink', 'Affiliation': 'Intensive Care Unit, Medizinische Klinik und Poliklinik I, Klinikum der Universität München, Marchioninistraße 15, 81377 Munich, Germany.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Orban', 'Affiliation': 'Intensive Care Unit, Medizinische Klinik und Poliklinik I, Klinikum der Universität München, Marchioninistraße 15, 81377 Munich, Germany.'}, {'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'Kupka', 'Affiliation': 'Intensive Care Unit, Medizinische Klinik und Poliklinik I, Klinikum der Universität München, Marchioninistraße 15, 81377 Munich, Germany.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Scherer', 'Affiliation': 'Intensive Care Unit, Medizinische Klinik und Poliklinik I, Klinikum der Universität München, Marchioninistraße 15, 81377 Munich, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hagl', 'Affiliation': 'Herzchirurgische Klinik und Poliklinik, Klinikum der Universität München, Marchioninistraße 15, 81377 Munich, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Zimmer', 'Affiliation': 'Medizinische Klinik und Poliklinik II, Universitätsklinikum Bonn, Sigmund-Freud-Straße 25, 53127 Bonn, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Luedike', 'Affiliation': 'Department of Cardiology and Vascular Medicine, West German Heart and Vascular Center, University Hospital Essen, Hufelandstraße 55, 45122 Essen, Germany.'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Thiele', 'Affiliation': 'Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology, Leipzig Heart Institute, Strümpellstraße 39, 04289 Leipzig, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Westermann', 'Affiliation': 'Klinik für Allgemeine und Interventionelle Kardiologie, Universitätsklinikum Hamburg-Eppendorf, Martinistraße 52, 20251 Hamburg, Germany.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Massberg', 'Affiliation': 'Intensive Care Unit, Medizinische Klinik und Poliklinik I, Klinikum der Universität München, Marchioninistraße 15, 81377 Munich, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Schäfer', 'Affiliation': 'Klinik für Kardiologie und Angiologie, Medizinische Hochschule Hannover, Carl-Neuberg-Straße 1, 30625 Hannover, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Orban', 'Affiliation': 'Intensive Care Unit, Medizinische Klinik und Poliklinik I, Klinikum der Universität München, Marchioninistraße 15, 81377 Munich, Germany.'}]",European heart journal,['10.1093/eurheartj/ehaa547']
2298,33098644,11βHSD1 inhibition with AZD4017 improves lipid profiles and lean muscle mass in Idiopathic intracranial hypertension.,"BACKGROUND


The enzyme 11β-hydroxysteroid dehydrogenase type 1 (11β-HSD1) determines pre-receptor metabolism and activation of glucocorticoids within peripheral tissues. Its dysregulation has been implicated in a wide array of metabolic diseases, leading to the development of selective 11β-HSD1 inhibitors. We examined the impact of the reversible competitive 11β-HSD1 inhibitor, AZD4017, on the metabolic profile in an overweight female cohort with idiopathic intracranial hypertension.
METHODS


We conducted a UK multicenter phase II randomized, double-blind, placebo-controlled trial of 12-week treatment with AZD4017. Serum markers of glucose homeostasis, lipid metabolism, renal and hepatic function, inflammation and androgen profiles were determined and examined in relation to changes in fat and lean mass by dual-energy X-ray absorptiometry (DXA).
RESULTS


Patients receiving AZD4017 showed significant improvements in lipid profiles (decreased cholesterol, increased HDL and cholesterol/HDL ratio), markers of hepatic function (decreased ALP and GGT) and increased lean muscle mass (1.8%, p<0.001). No changes in BMI, fat mass and markers of glucose metabolism or inflammation were observed. Patients receiving AZD4017 demonstrated increased levels of circulating androgens, positively correlated with changes in total lean muscle mass.
CONCLUSIONS


These beneficial metabolic changes, represent a reduction in risk factors associated with raised intra-cranial pressure and represent further beneficial therapeutic outcomes of 11β-HSD1 inhibition by AZD4017 in this overweight IIH cohort. In particular, beneficial changes in lean muscle mass associated with AZD4017 may reflect new applications for this nature of inhibitor in the management of conditions such as sarcopenia.",2020,"Patients receiving AZD4017 demonstrated increased levels of circulating androgens, positively correlated with changes in total lean muscle mass.
","['Idiopathic intracranial hypertension', 'overweight female cohort with idiopathic intracranial hypertension']","['placebo', 'AZD4017']","['BMI, fat mass and markers of glucose metabolism or inflammation', 'lipid profiles and lean muscle mass', 'lipid profiles (decreased cholesterol, increased HDL and cholesterol/HDL ratio), markers of hepatic function (decreased ALP and GGT) and increased lean muscle mass', 'total lean muscle mass', 'levels of circulating androgens', 'Serum markers of glucose homeostasis, lipid metabolism, renal and hepatic function, inflammation and androgen profiles']","[{'cui': 'C0033845', 'cui_str': 'Benign intracranial hypertension'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3501337', 'cui_str': 'AZD4017'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0853084', 'cui_str': 'High density lipoprotein increased'}, {'cui': 'C0523558', 'cui_str': 'Cholesterol/HDL ratio measurement'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C0002059', 'cui_str': 'Alkaline phosphatase'}, {'cui': 'C0017040', 'cui_str': 'Gamma-glutamyltransferase'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0002844', 'cui_str': 'Androgen'}, {'cui': 'C0162491', 'cui_str': 'Marker, Serum'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}]",,0.0344448,"Patients receiving AZD4017 demonstrated increased levels of circulating androgens, positively correlated with changes in total lean muscle mass.
","[{'ForeName': 'Rowan S', 'Initials': 'RS', 'LastName': 'Hardy', 'Affiliation': 'Institute of Metabolism and Systems Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, United Kingdom, UK.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Botfield', 'Affiliation': 'Institute of Inflammation and Ageing, College of Medical and Dental Sciences, University of Birmingham, Birmingham, United Kingdom, UK.'}, {'ForeName': 'Keira', 'Initials': 'K', 'LastName': 'Markey', 'Affiliation': 'Institute of Metabolism and Systems Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, United Kingdom, UK.'}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Mitchell', 'Affiliation': 'Institute of Metabolism and Systems Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, United Kingdom, UK.'}, {'ForeName': 'Zerin', 'Initials': 'Z', 'LastName': 'Alimajstorovic', 'Affiliation': 'Institute of Metabolism and Systems Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, United Kingdom, UK.'}, {'ForeName': 'Connar S J', 'Initials': 'CSJ', 'LastName': 'Westgate', 'Affiliation': 'Institute of Metabolism and Systems Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, United Kingdom, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Sagmeister', 'Affiliation': 'Institute of Metabolism and Systems Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, United Kingdom, UK.'}, {'ForeName': 'Rebecca J', 'Initials': 'RJ', 'LastName': 'Fairclough', 'Affiliation': 'Emerging Innovations Unit, Discovery Sciences. BioPharmaceuticals R&D, AstraZeneca, Cambridge UK.'}, {'ForeName': 'Ryan S', 'Initials': 'RS', 'LastName': 'Ottridge', 'Affiliation': 'Birmingham Clinical Trials Unit, Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Yiangou', 'Affiliation': 'Institute of Metabolism and Systems Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, United Kingdom, UK.'}, {'ForeName': 'Karl-Heinz', 'Initials': 'KH', 'LastName': 'H Storbeck', 'Affiliation': 'Institute of Metabolism and Systems Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, United Kingdom, UK.'}, {'ForeName': 'Angela E', 'Initials': 'AE', 'LastName': 'Taylor', 'Affiliation': 'Institute of Metabolism and Systems Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, United Kingdom, UK.'}, {'ForeName': 'Lorna C', 'Initials': 'LC', 'LastName': 'Gilligan', 'Affiliation': 'Institute of Metabolism and Systems Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, United Kingdom, UK.'}, {'ForeName': 'Wiebke', 'Initials': 'W', 'LastName': 'Arlt', 'Affiliation': 'Institute of Metabolism and Systems Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, United Kingdom, UK.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Stewart', 'Affiliation': 'Medical School, University of Leeds, Leeds, UK.'}, {'ForeName': 'Jeremy W', 'Initials': 'JW', 'LastName': 'Tomlinson', 'Affiliation': 'Oxford Centre for Diabetes, Endocrinology & Metabolism (OCDEM), NIHR Oxford Biomedical Research Centre, University of Oxford, Churchill Hospital, Headington, Oxford, UK.'}, {'ForeName': 'Susan P', 'Initials': 'SP', 'LastName': 'Mollan', 'Affiliation': 'Institute of Metabolism and Systems Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, United Kingdom, UK.'}, {'ForeName': 'Gareth G', 'Initials': 'GG', 'LastName': 'Lavery', 'Affiliation': 'Institute of Metabolism and Systems Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, United Kingdom, UK.'}, {'ForeName': 'Alexandra J', 'Initials': 'AJ', 'LastName': 'Sinclair', 'Affiliation': 'Institute of Metabolism and Systems Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, United Kingdom, UK.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa766']
2299,33098672,Perinatal death audit and classification of stillbirths in two provinces in Papua New Guinea: a retrospective analysis.,"OBJECTIVE


To undertake a retrospective perinatal death audit and assessment of avoidable factors associated with stillbirths among a cohort of women in two provinces in Papua New Guinea.
METHODS


We used data from an ongoing cluster-randomised crossover trial in 10 sites among 4,600 women in Papua New Guinea (2017-date). The overarching aim is to improve birth outcomes. All stillbirths from July 2017 to January 2020 were identified. The Perinatal Problem Identification Program was used to analyse each stillbirth and review associated avoidable factors.
RESULTS


There were 59 stillbirths among 2558 births (23 per 1,000 births). 68% (40/59) were classified 'fresh' and 32% 'macerated'. Perinatal cause of death was identified for 63% (37/59); 30% (11/37) were due to intrapartum asphyxia and traumatic breech birth; and 19% (7/37) due to pre-eclampsia. 95% (56/59) of stillbirths had at least one avoidable factor identified. Patient-associated factors included lack of response to reduced fetal movements and delay in seeking care during labor. Health personnel-associated factors included poor intrapartum care, late diagnosis of breech presentation and prolonged second stage with no intervention.
CONCLUSION


Factors associated with stillbirths in this setting could be avoided through a package of interventions at both the community and health facility level.",2020,Perinatal cause of death was identified for 63% (37/59); 30% (11/37) were due to intrapartum asphyxia and traumatic breech birth; and 19% (7/37) due to pre-eclampsia. 95% (56/59) of stillbirths had at least one avoidable factor identified.,"['4,600 women in Papua New Guinea (2017-date', 'All stillbirths from July 2017 to January 2020 were identified', 'two provinces in Papua New Guinea', 'women in two provinces in Papua New Guinea']",[],"['Perinatal death audit and classification of stillbirths', 'Perinatal cause of death', 'intrapartum asphyxia and traumatic breech birth']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030375', 'cui_str': 'Papua New Guinea'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0595939', 'cui_str': 'Stillbirth'}, {'cui': 'C0205396', 'cui_str': 'Identified'}]",[],"[{'cui': 'C0701826', 'cui_str': 'Perinatal death'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0595939', 'cui_str': 'Stillbirth'}, {'cui': 'C0178795', 'cui_str': 'Perinatal period'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0004045', 'cui_str': 'Asphyxia, in liveborn infant'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0005615', 'cui_str': 'Birth'}]",4600.0,0.072143,Perinatal cause of death was identified for 63% (37/59); 30% (11/37) were due to intrapartum asphyxia and traumatic breech birth; and 19% (7/37) due to pre-eclampsia. 95% (56/59) of stillbirths had at least one avoidable factor identified.,"[{'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Vallely', 'Affiliation': 'The Kirby Institute, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Smith', 'Affiliation': 'Maternal, Child and Adolescent Health Program, Burnet Institute, Melbourne, Australia.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Bolnga', 'Affiliation': 'Modilon Hospital, Madang, Papua New Guinea.'}, {'ForeName': 'Delly', 'Initials': 'D', 'LastName': 'Babona', 'Affiliation': ""St Mary's Hospital Vunapope, East New Britain Province, Papua New Guinea.""}, {'ForeName': 'Michaela A', 'Initials': 'MA', 'LastName': 'Riddell', 'Affiliation': 'The Kirby Institute, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Mengi', 'Affiliation': 'Papua New Guinea Institute of Medical Research, Papua New Guinea.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Au', 'Affiliation': 'Papua New Guinea Institute of Medical Research, Papua New Guinea.'}, {'ForeName': 'Cherolyn', 'Initials': 'C', 'LastName': 'Polomon', 'Affiliation': 'Pacific Adventist University, Port Moresby, Papua New Guinea.'}, {'ForeName': 'Joshua P', 'Initials': 'JP', 'LastName': 'Vogel', 'Affiliation': 'Maternal, Child and Adolescent Health Program, Burnet Institute, Melbourne, Australia.'}, {'ForeName': 'William S', 'Initials': 'WS', 'LastName': 'Pomat', 'Affiliation': 'Papua New Guinea Institute of Medical Research, Papua New Guinea.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Vallely', 'Affiliation': 'The Kirby Institute, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Caroline Se', 'Initials': 'CS', 'LastName': 'Homer', 'Affiliation': 'Maternal, Child and Adolescent Health Program, Burnet Institute, Melbourne, Australia.'}]",International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics,['10.1002/ijgo.13431']
2300,33098678,Sphincter-saving surgery for ultra-low rectal carcinoma initially indicated for abdominoperineal resection: Is it safe on a long-term follow-up?,"BACKGROUND


Rate of abdominoperineal resection (APR) varies from countries and surgeons. Surgical impact of preoperative treatment for ultra-low rectal carcinoma (ULRC) initially indicated for APR is debated. We report the 10-year oncological results from a prospective controlled trial (GRECCAR 1) which evaluate the sphincter saving surgery (SSR).
METHODS


ULRC indicated for APR were included (n = 207). Randomization was between high-dose radiation (HDR, 45 + 18 Gy) and radiochemotherapy (RCT, 45 Gy + 5FU infusion). Surgical decision was based on tumour volume regression at surgery. SSR technique was standardized as mucosectomy (M) or partial (PISR)/complete (CISR) intersphincteric resection.
RESULTS


Overall SSR rate was 85% (72% ISR), postoperative morbidity 27%, with no mortality. There were no significant differences between the HDR and RCT groups: 10-year overall survival (OS10) 70.1% versus 69.4%, respectively, 10.2% local recurrence (9.2%/14.5%) and 27.6% metastases (32.4%/27.7%). OS and disease-free survival were significantly longer for SSR (72.2% and 60.1%, respectively) versus APR (54.7% and 38.3%). No difference in OS10 between surgical approaches (M 78.9%, PISR 75.5%, CISR 65.5%) or tumour location (low 64.8%, ultralow 76.7%).
CONCLUSION


GRECCAR 1 demonstrates the feasibility of safely changing an initial APR indication into an SSR procedure according to the preoperative treatment tumour response. Long-term oncologic follow-up validates this attitude.",2020,"There were no significant differences between the HDR and RCT groups: 10-year overall survival (OS10) 70.1% versus 69.4%, respectively, 10.2% local recurrence (9.2%/14.5%) and 27.6% metastases (32.4%/27.7%).",['ultra-low rectal carcinoma (ULRC'],"['radiochemotherapy (RCT', 'SSR technique was standardized as mucosectomy (M) or partial (PISR)/complete (CISR) intersphincteric resection', 'sphincter saving surgery (SSR', 'abdominoperineal resection', 'abdominoperineal resection (APR', 'Sphincter-saving surgery']","['OS10', 'OS and disease-free survival', 'Overall SSR rate', '10-year overall survival', 'local recurrence', 'tumour location', 'postoperative morbidity']","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}]","[{'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C2004459', 'cui_str': 'Abdominoperineal resection'}]","[{'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",,0.0887286,"There were no significant differences between the HDR and RCT groups: 10-year overall survival (OS10) 70.1% versus 69.4%, respectively, 10.2% local recurrence (9.2%/14.5%) and 27.6% metastases (32.4%/27.7%).","[{'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Rouanet', 'Affiliation': ""Department of Surgical Oncology, Institut régional du Cancer de Montpellier (ICM) - Val d'Aurelle, Montpellier, France.""}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Rivoire', 'Affiliation': 'Department of Surgical Oncology, Centre Léon Berard, Lyon, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Gourgou', 'Affiliation': 'Montpellier Cancer Institute, Biometrics Unit, Montpellier, France.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Lelong', 'Affiliation': 'Department of Surgical Oncology, Institut Paoli Calmettes, Marseille, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Rullier', 'Affiliation': 'Colorectal département, CHU Bordeaux, Bordeaux, France.'}, {'ForeName': 'Merhdad', 'Initials': 'M', 'LastName': 'Jafari', 'Affiliation': 'Department of Surgical Oncology, Centre Oscar Lambret, Lille, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Mineur', 'Affiliation': 'Department of Radiation Oncology, Institut Sainte Catherine, Avignon, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Pocard', 'Affiliation': 'Department of Surgical Oncology, Gustave Roussy (hopit Mal Lariboisiere APHP), Paris, France.'}, {'ForeName': 'Jean Luc', 'Initials': 'JL', 'LastName': 'Faucheron', 'Affiliation': 'Colorectal département, CHU Grenoble, Grenoble, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Dravet', 'Affiliation': 'Department of Surgical Oncology, Centre René Gauducheau, Nantes, France.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Pezet', 'Affiliation': 'Colorectal département, CHU Clermont-Ferrand, Clermont-Ferrand, France.'}, {'ForeName': 'Jean Michel', 'Initials': 'JM', 'LastName': 'Fabre', 'Affiliation': 'Colorectal département, CHU Montpellier, Montpellier, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Bresler', 'Affiliation': 'Colorectal département, CHU Nancy, Nancy, France.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Balosso', 'Affiliation': 'Department of Radiotherapy, CHU Grenoble, Grenoble, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Taoum', 'Affiliation': ""Department of Surgical Oncology, Institut régional du Cancer de Montpellier (ICM) - Val d'Aurelle, Montpellier, France.""}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Lemanski', 'Affiliation': ""Department of Radiotherapy, Institut régional du Cancer de Montpellier (ICM) - Val d'Aurelle, Montpellier, France.""}]",Journal of surgical oncology,['10.1002/jso.26249']
2301,33098709,"Is the ""end-of-study guess"" a valid measure of sham blinding during transcranial direct current stimulation?","Studies using transcranial direct current stimulation (tDCS) typically incorporate a fade-in, short-stimulation, fade-out sham (placebo) protocol, which is assumed to be indistinct from a 10-30min active protocol on the scalp. However, many studies report that participants can dissociate active stimulation from sham, even during low-intensity 1mA currents. We recently identified differences in the perception of an active (10min of 1mA) and a sham (20s of 1mA) protocol that lasted for 5 mins after the cessation of sham. In the present study we assessed whether delivery of a higher-intensity 2mA current would exacerbate these differences. Two protocols were delivered to 32 adults in a double-blinded, within-subjects design (active: 10min of 2mA, and sham: 20s of 2mA), with the anode over the left primary motor cortex and the cathode on the right forehead. Participants were asked ""Is the stimulation on?"" and ""How sure are you?"" at 30s intervals during and after stimulation. The differences between active and sham were more consistent and sustained during 2mA than during 1mA. We then quantified how well participants were able to track the presence and absence of stimulation (i.e. their sensitivity) during the experiment using cross-correlations. Current strength was a good classifier of sensitivity during active tDCS, but exhibited only moderate specificity during sham. The accuracy of the end-of-study guess was no better than chance at predicting sensitivity. Our results indicate that the traditional end-of-study guess poorly reflects the sensitivity of participants to stimulation, and may not be a valid method of assessing sham blinding.",2020,The differences between active and sham were more consistent and sustained during 2mA than during 1mA. We then quantified how well participants were able to track the presence and absence of stimulation (i.e. their sensitivity) during the experiment using cross-correlations.,[],['transcranial direct current stimulation (tDCS'],[],[],"[{'cui': 'C3850024', 'cui_str': 'tDCS'}]",[],,0.212609,The differences between active and sham were more consistent and sustained during 2mA than during 1mA. We then quantified how well participants were able to track the presence and absence of stimulation (i.e. their sensitivity) during the experiment using cross-correlations.,"[{'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Turner', 'Affiliation': 'School of Psychology, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Jackson', 'Affiliation': 'School of Psychology, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Learmonth', 'Affiliation': 'School of Psychology, University of Glasgow, Glasgow, UK.'}]",The European journal of neuroscience,['10.1111/ejn.15018']
2302,33099083,Selfhood triumvirate: From phenomenology to brain activity and back again.,"Recently, a three-dimensional construct model for complex experiential Selfhood has been proposed (Fingelkurts, Fingelkurts, & Kallio-Tamminen, 2016b,c). According to this model, three specific subnets (or modules) of the brain self-referential network (SRN) are responsible for the manifestation of three aspects/features of the subjective sense of Selfhood. Follow up multiple studies established a tight relation between alterations in the functional integrity of the triad of SRN modules and related to them three aspects/features of the sense of self; however, the causality of this relation is yet to be shown. In this article we approached the question of causality by exploring functional integrity within the three SRN modules that are thought to underlie the three phenomenal components of Selfhood while these components were manipulated mentally by experienced meditators in a controlled and independent manner. Participants were requested, in a block-randomised manner, to mentally induce states representing either increased (up-regulation) or decreased (down-regulation) sense of (a) witnessing agency (""Self""), or (b) body representational-emotional agency (""Me""), or (c) reflective/narrative agency (""I""), while their brain activity was recorded by an electroencephalogram (EEG). This EEG-data was complemented by first-person phenomenological reports and standardised questionnaires which focused on subjective contents of three aspects of Selfhood. The results of the study strengthen the case for a direct causative relationship between three phenomenological aspects of Selfhood and related to them three modules of the brain SRN. Furthermore, the putative integrative model of the dynamic interrelations among three modules of the SRN has been proposed.",2020,"Participants were requested, in a block-randomised manner, to mentally induce states representing either increased (up-regulation) or decreased (down-regulation) sense of (a) witnessing agency (""Self""), or (b) body representational-emotional agency (""Me""), or (c) reflective/narrative agency (""I""), while their brain activity was recorded by an electroencephalogram (EEG).",[],"['mentally induce states representing either increased (up-regulation) or decreased (down-regulation) sense of (a) witnessing agency (""Self""), or (b) body representational-emotional agency (""Me""), or (c) reflective/narrative agency (""I""), while their brain activity was recorded by an electroencephalogram (EEG']",[],[],"[{'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0041904', 'cui_str': 'Up-Regulation (Physiology)'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0013081', 'cui_str': 'Down-regulation'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C1135957', 'cui_str': 'Narration'}, {'cui': 'C0443158', 'cui_str': 'Brain activity'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}]",[],,0.0183146,"Participants were requested, in a block-randomised manner, to mentally induce states representing either increased (up-regulation) or decreased (down-regulation) sense of (a) witnessing agency (""Self""), or (b) body representational-emotional agency (""Me""), or (c) reflective/narrative agency (""I""), while their brain activity was recorded by an electroencephalogram (EEG).","[{'ForeName': 'Andrew A', 'Initials': 'AA', 'LastName': 'Fingelkurts', 'Affiliation': 'BM-Science - Brain and Mind Technologies Research Centre, Espoo, Finland. Electronic address: andrew.fingelkurts@bm-science.com.'}, {'ForeName': 'Alexander A', 'Initials': 'AA', 'LastName': 'Fingelkurts', 'Affiliation': 'BM-Science - Brain and Mind Technologies Research Centre, Espoo, Finland.'}, {'ForeName': 'Tarja', 'Initials': 'T', 'LastName': 'Kallio-Tamminen', 'Affiliation': 'Physics Foundations Society and Society for Natural Philosophy, Helsinki, Finland.'}]",Consciousness and cognition,['10.1016/j.concog.2020.103031']
2303,33099092,Back foot influence on dorsiflexion using three different positions of the weight bearing lunge test.,"OBJECTIVES


To determine whether back foot (BF) position influences dorsiflexion range of motion (DFROM) during three different positions of the weight bearing lunge test (WBLT).
DESIGN


Randomised, repeated measures design.
SETTING


Sports clubs.
PARTICIPANTS


52 athletes participating in cutting and pivoting sports.
MAIN OUTCOME MEASURES


DFROM was obtained using a WBLT in three different BF positions: BF heel in full contact with the floor, BF heel raised off the floor and BF was non weight bearing (NWB). All measurements were obtained using three methods: inclinometer at the tibial tuberosity, toe to wall distance and goniometer angle from the lateral malleolus to the fibula head. Differences between testing positions were determined using a repeated measures one-way ANOVA and reliability analysis was performed using the Intraclass Correlation Coefficient (ICC).
RESULTS


DFROM was statistically significantly different for all three positions of the WBLT for each measurement technique (P < .001). These results were associated with large effect sizes for all BF positions and measurement techniques. Reliability ICC values were excellent for all measurements (ICC 0.94-0.99).
CONCLUSIONS


Results show that DFROM differs depending upon the position of the BF during the WBLT. Further research is needed to establish the reproducibility of these three BF positions due to the variability observed.",2020,"RESULTS


DFROM was statistically significantly different for all three positions of the WBLT for each measurement technique (P < .001).","['Sports clubs', '52 athletes participating in cutting and pivoting sports']",[],"['BF positions: BF heel in full contact with the floor, BF heel raised off the floor and BF was non weight bearing (NWB', 'DFROM', 'back foot (BF) position influences dorsiflexion range of motion (DFROM', 'Reliability ICC values']","[{'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0149651', 'cui_str': 'Clubbing'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0000925', 'cui_str': 'Incised wound'}]",[],"[{'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0018870', 'cui_str': 'Heel structure'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0016249', 'cui_str': 'Walking surface of room'}, {'cui': 'C0442818', 'cui_str': 'Raised'}, {'cui': 'C0445100', 'cui_str': 'Non-weight-bearing'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0010101', 'cui_str': 'Correlation Studies'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",52.0,0.0302354,"RESULTS


DFROM was statistically significantly different for all three positions of the WBLT for each measurement technique (P < .001).","[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Cady', 'Affiliation': 'School of Sport and Exercise, University of Gloucestershire, Oxstalls Campus, Oxstalls Lane, Gloucester, GL2 9HW, UK; School of Life and Medical Sciences, University of Hertfordshire, College Lane, Hatfield, Hertfordshire, AL10 9AB, UK. Electronic address: k.cady2@herts.ac.uk.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'De Ste Croix', 'Affiliation': 'School of Sport and Exercise, University of Gloucestershire, Oxstalls Campus, Oxstalls Lane, Gloucester, GL2 9HW, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Deighan', 'Affiliation': 'School of Sport and Exercise, University of Gloucestershire, Oxstalls Campus, Oxstalls Lane, Gloucester, GL2 9HW, UK.'}]",Physical therapy in sport : official journal of the Association of Chartered Physiotherapists in Sports Medicine,['10.1016/j.ptsp.2020.10.005']
2304,33099189,Do the metrics matter? An experimental investigation of Instagram influencer effects on mood and body dissatisfaction.,"Instagram is saturated with content from 'influencers', users who create high-quality idealised content, attain celebrity-level following, and often leverage their popularity to earn money through brand partnership/promotion. Although existing literature generally indicates the negative impact of idealised Instagram imagery on female psychological wellbeing, influencer imagery has yet to receive thorough attention. We investigated the impact of high versus low popularity influencer images on mood and body dissatisfaction. Adult women (N = 111, aged 17-40) were randomly allocated to one of three groups: either (1) the influencer-high group (idealised imagery alongside high 'like'/follow metrics); (2) the influencer-low group (the same idealised imagery adjusted for low popularity metrics); or (3) a nature control group with matched low-popularity metrics. Results revealed significantly higher negative mood and body dissatisfaction within the two influencer imagery groups compared with the control group. Interestingly, comparisons revealed no significant differences between the influencer-high and influencer-low groups on mood and body dissatisfaction. The findings suggest that users should be aware of the potentially negative impacts of viewing idealised influencer imagery, regardless of whether the content is high or low in popularity.",2020,"Interestingly, comparisons revealed no significant differences between the influencer-high and influencer-low groups on mood and body dissatisfaction.","['Adult women (N = 111, aged 17-40']","[""influencer-high group (idealised imagery alongside high 'like'/follow metrics); (2) the influencer-low group (the same idealised imagery adjusted for low popularity metrics); or (3) a nature control group with matched low-popularity metrics""]","['negative mood and body dissatisfaction', 'mood and body dissatisfaction']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517538', 'cui_str': '111'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0349590', 'cui_str': 'Nature'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C2732632', 'cui_str': 'Dissatisfaction with body image'}]",111.0,0.0293242,"Interestingly, comparisons revealed no significant differences between the influencer-high and influencer-low groups on mood and body dissatisfaction.","[{'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Lowe-Calverley', 'Affiliation': 'University of Tasmania, Australia. Electronic address: Emily.Lowe@utas.edu.au.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Grieve', 'Affiliation': 'University of Tasmania, Australia. Electronic address: Rachel.Grieve@utas.edu.au.'}]",Body image,['10.1016/j.bodyim.2020.10.003']
2305,33099227,Effect of growth hormone treatment on circulating levels of NT-proBNP in patients with ischemic heart failure.,"AIMS


Growth hormone (GH) therapy in heart failure (HF) is controversial. We investigated the cardiovascular effects of GH in patients with chronic HF due to ischemic heart disease.
METHODS


In a double-blind, placebo-controlled trial, we randomly assigned 37 patients (mean age 66 years; 95% male) with ischemic HF (ejection fraction [EF] < 40%) to a 9-month treatment with either recombinant human GH (1.4 mg every other day) or placebo, with subsequent 3-month treatment-free follow-up. The primary outcome was change in left ventricular (LV) end-systolic volume measured by cardiac magnetic resonance (CMR). Secondary outcomes comprised changes in cardiac structure and EF. Prespecified tertiary outcomes included changes in New York Heat Association (NYHA) functional class and quality of life (QoL), as well as levels of insulin-like growth factor-1 (IGF-1) and N-terminal pro-brain natriuretic peptide (NT-proBNP).
RESULTS


No changes in cardiac structure or systolic function were identified in either treatment group; nor did GH treatment affect QoL or functional class. In the GH group, circulating levels of IGF-1 doubled from baseline (+105%; p < 0.001) and NT-proBNP levels halved (-48%; p < 0.001) during the treatment period, with subsequently a partial return of both towards baseline levels. No changes in IGF-1 or NT-proBNP were observed in the placebo group at any time during the study.
CONCLUSION


In patients with chronic ischemic HF, nine months of GH treatment was associated with significant increases in levels of IGF-1 and reductions in levels of NT-proBNP, but did not affect cardiac structure, systolic function or functional capacity.",2020,No changes in cardiac structure or systolic function were identified in either treatment group; nor did GH treatment affect QoL or functional class.,"['patients with chronic HF due to ischemic heart disease', 'heart failure (HF', 'patients with ischemic heart failure', '37 patients (mean age 66\xa0years; 95% male) with ischemic HF']","['growth hormone treatment', 'GH', 'recombinant human GH', 'placebo', 'Growth hormone (GH) therapy']","['circulating levels of IGF-1', 'circulating levels of NT-proBNP', 'changes in cardiac structure and EF', 'changes in New York Heat Association (NYHA) functional class and quality of life (QoL), as well as levels of insulin-like growth factor-1 (IGF-1) and N-terminal pro-brain natriuretic peptide (NT-proBNP', 'IGF-1 or NT-proBNP', 'NT-proBNP levels', 'change in left ventricular (LV) end-systolic volume measured by cardiac magnetic resonance (CMR', 'cardiac structure or systolic function', 'cardiac structure, systolic function or functional capacity', 'levels of IGF-1 and reductions in levels of NT-proBNP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0151744', 'cui_str': 'Myocardial ischemia'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0037663', 'cui_str': 'Somatotropin'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0169964', 'cui_str': 'Somatropin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1533071', 'cui_str': 'N terminal pro-brain natriuretic peptide level'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",37.0,0.265861,No changes in cardiac structure or systolic function were identified in either treatment group; nor did GH treatment affect QoL or functional class.,"[{'ForeName': 'Kristjan', 'Initials': 'K', 'LastName': 'Karason', 'Affiliation': 'Departments of Cardiology and Transplantation, Sahlgrenska University Hospital, Gothenburg, Sweden; Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden. Electronic address: kristjan.karason@gu.se.'}, {'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Bobbio', 'Affiliation': 'Departments of Cardiology and Transplantation, Sahlgrenska University Hospital, Gothenburg, Sweden; Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Polte', 'Affiliation': 'Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Departments of Clinical Physiology and Radiology, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Entela', 'Initials': 'E', 'LastName': 'Bollano', 'Affiliation': 'Departments of Cardiology and Transplantation, Sahlgrenska University Hospital, Gothenburg, Sweden; Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Peterson', 'Affiliation': 'Department of Medicine, Lidköping Hospital, Lidköping, Sweden.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Cittadini', 'Affiliation': 'Department of Translational Medical Science, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Caidahl', 'Affiliation': 'Department of Molecular Medicine and Surgery, Karolinska Institute (KI), Stockholm, Sweden.'}, {'ForeName': 'Åke', 'Initials': 'Å', 'LastName': 'Hjalmarson', 'Affiliation': 'Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Bengt-Åke', 'Initials': 'BÅ', 'LastName': 'Bengtsson', 'Affiliation': 'Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Ekelund', 'Affiliation': 'Centre of Registers Västra Götaland, Gothenburg, Sweden.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Swedberg', 'Affiliation': 'National Heart and Lung Institute, Imperial College, London, UK.'}, {'ForeName': 'Jörgen', 'Initials': 'J', 'LastName': 'Isgaard', 'Affiliation': 'Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Department of Medicine, Sahlgrenska University Hospital, Gothenburg, Sweden.'}]",Growth hormone & IGF research : official journal of the Growth Hormone Research Society and the International IGF Research Society,['10.1016/j.ghir.2020.101359']
2306,33098739,Early Parenting Intervention Accelerates Inhibitory Control Development among CPS-Involved Children in Middle Childhood: A Randomized Clinical Trial.,"Children at risk for neglect or abuse are vulnerable to delays in inhibitory control development. Prior findings suggest that early parenting interventions that target parental sensitivity and responsiveness during infancy can improve executive function outcomes of high-risk children during preschool years; however, little is known about how persistent these gains are through middle childhood. Participants included 76 CPS-involved children who were randomly assigned to either the ABC intervention (N = 32) or the Developmental Education for Families (DEF) control intervention (N = 44), and 53 low-risk children. Children completed the Stop Signal Reaction Time (SSRT) paradigm at ages 8 and 10. Intervention group predicted performance on the SSRT at age 8 such that children who received the ABC intervention and children in the low-risk group performed significantly better than children who received the DEF intervention (ABC vs. DEF: Cohen's d = .92; low-risk group vs. DEF: d = .56) . The performances of the ABC and the low-risk groups were not statistically different. There were no significant group differences in SSRT performance at age 10. These findings demonstrate that the ABC intervention has long-term beneficial effects on inhibitory control development in children with a history of early caregiving adversity.",2020,The performances of the ABC and the low-risk groups were not statistically different.,"['N = 44), and 53 low-risk children', 'Participants included 76 CPS-involved children', 'high-risk children during preschool years', 'children with a history of early caregiving adversity', 'CPS-Involved Children in Middle Childhood']","['DEF intervention (ABC vs. DEF', 'ABC intervention (N = 32) or the Developmental Education for Families (DEF) control intervention', 'ABC intervention', 'Early Parenting Intervention']","['Stop Signal Reaction Time (SSRT) paradigm', 'SSRT performance', 'executive function outcomes']","[{'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0149958', 'cui_str': 'Partial Seizures, Complex'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}]","[{'cui': 'C0458003', 'cui_str': 'Developmental'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0152244', 'cui_str': 'Aneurysmal bone cyst'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}]","[{'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",76.0,0.0420485,The performances of the ABC and the low-risk groups were not statistically different.,"[{'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Korom', 'Affiliation': 'Department of Psychological and Brain Sciences, University of Delaware.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Goldstein', 'Affiliation': 'Department of Psychological and Brain Sciences, University of Delaware.'}, {'ForeName': 'Alexandra R', 'Initials': 'AR', 'LastName': 'Tabachnick', 'Affiliation': 'Department of Psychological and Brain Sciences, University of Delaware.'}, {'ForeName': 'Erin N', 'Initials': 'EN', 'LastName': 'Palmwood', 'Affiliation': 'Department of Psychological and Brain Sciences, University of Delaware.'}, {'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Simons', 'Affiliation': 'Department of Psychological and Brain Sciences, University of Delaware.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Dozier', 'Affiliation': 'Department of Psychological and Brain Sciences, University of Delaware.'}]",Developmental science,['10.1111/desc.13054']
2307,32689628,Effects of gait exercise assist robot (GEAR) on subjects with chronic stroke: A randomized controlled pilot trial.,"OBJECTIVE


The aim of this study was to investigate whether gait training using the Gait Exercise Assist Robot (GEAR) is more effective for improving gait ability than treadmill gait training in chronic stroke subjects.
DESIGN


Subjects were randomly assigned to either the GEAR group (n = 8) or treadmill group (n = 11). Both groups received a training program of 20 sessions (5 days/week). The 10-m walk test, Timed Up and Go (TUG) test, 6-min walk test, the Medical Outcome Study 8-item Short Form Health Survey (SF-8), and Global Rating of Change (GRC) scales were administered at baseline (week 0), completion of training (week 4), 1-mo follow-up (week 8), and 3-mo follow-up (week 16).
RESULTS


Gait speed was significantly increased at completion of training and 1-mo follow-up compared with baseline in the GEAR group. Mean changes in TUG and 6-min walk were significantly greater in the GEAR group than in the treadmill group at completion of training compared to baseline. Furthermore, GRC scales were significantly increased at completion of training, 1-mo follow-up, and 3-mo follow-up compared with baseline in the GEAR group.
CONCLUSION


This study suggests that gait training using GEAR was more effective for improving gait ability than treadmill among subjects with chronic stroke.
REGISTRATION OF CLINICAL TRIALS


This study was registered with the University Hospital Medical Information Network (No. UMIN000028042).",2020,Gait speed was significantly increased at completion of training and 1-mo follow-up compared with baseline in the GEAR group.,"['Subjects', 'subjects with chronic stroke', 'chronic stroke subjects']","['gait training', 'Gait Exercise Assist Robot (GEAR', 'gait training using GEAR', 'GEAR', 'treadmill gait training', 'gait exercise assist robot (GEAR']","['gait ability', '10-m walk test, Timed Up and Go (TUG) test, 6-min walk test, the Medical Outcome Study 8-item Short Form Health Survey (SF-8), and Global Rating of Change ', 'GRC) scales', 'Gait speed', 'Furthermore, GRC scales', 'Mean changes in TUG and 6-min walk']","[{'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}]","[{'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}]","[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0543472', 'cui_str': 'Outcome Studies'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0080331', 'cui_str': 'Walking'}]",,0.0368056,Gait speed was significantly increased at completion of training and 1-mo follow-up compared with baseline in the GEAR group.,"[{'ForeName': 'Tomoyuki', 'Initials': 'T', 'LastName': 'Ogino', 'Affiliation': 'Department of Rehabilitation, Hyogo College of Medicine Sasayama Medical Center, Kurooka 5, Sasayama, Hyogo 669-2321, Japan. Electronic address: ogino0327@gmail.com.'}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Kanata', 'Affiliation': 'Department of Rehabilitation, Hyogo College of Medicine Sasayama Medical Center, Kurooka 5, Sasayama, Hyogo 669-2321, Japan. Electronic address: ym_kanata611@yahoo.co.jp.'}, {'ForeName': 'Ryota', 'Initials': 'R', 'LastName': 'Uegaki', 'Affiliation': 'Department of Rehabilitation, Hyogo College of Medicine Sasayama Medical Center, Kurooka 5, Sasayama, Hyogo 669-2321, Japan. Electronic address: ri-uegaki@hyo-med.ac.jp.'}, {'ForeName': 'Tatuya', 'Initials': 'T', 'LastName': 'Yamaguchi', 'Affiliation': 'Department of Rehabilitation, Hyogo College of Medicine Sasayama Medical Center, Kurooka 5, Sasayama, Hyogo 669-2321, Japan. Electronic address: tt-yamaguchi@hyo-med.ac.jp.'}, {'ForeName': 'Katuhisa', 'Initials': 'K', 'LastName': 'Morisaki', 'Affiliation': 'Department of Rehabilitation, Hyogo College of Medicine Sasayama Medical Center, Kurooka 5, Sasayama, Hyogo 669-2321, Japan. Electronic address: kindai_lacrosse_8@yahoo.co.jp.'}, {'ForeName': 'Shuhei', 'Initials': 'S', 'LastName': 'Nakano', 'Affiliation': 'Department of Rehabilitation, Hyogo College of Medicine Sasayama Medical Center, Kurooka 5, Sasayama, Hyogo 669-2321, Japan. Electronic address: stp.tig.6gd@gmail.com.'}, {'ForeName': 'Kazuhisa', 'Initials': 'K', 'LastName': 'Domen', 'Affiliation': 'Department of Rehabilitation Medicine, Hyogo College of Medicine, Japan. Electronic address: domen@hyo-med.ac.jp.'}]",Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association,['10.1016/j.jstrokecerebrovasdis.2020.104886']
2308,32691272,Student Knowledge Gain Following the Second Step Child Protection Unit: the Influence of Treatment Integrity.,"Treatment integrity is an important yet understudied component of school-based prevention programming, particularly for sensitive topics such as child sexual abuse prevention (CSA). This study examined student- and teacher-level characteristics, including components of treatment integrity, that contributed to greater knowledge gain among students participating in the Second Step Child Protection Unit (CPU). The study was conducted with 1132 students and 57 teachers from four elementary schools enrolled in a randomized controlled trial of the CPU. Students were administered assessments at pre-test, post-test, 6-month follow-up, and 12-month follow-up. Teachers were observed and rated on Content Integrity (CI; adherence to content), Process Integrity (PI; teacher enthusiasm, encouragement, behavior management), and Dose Received (DR; student behavior and interest) when delivering the lessons. Hierarchical linear growth modeling indicated that students who received the CPU made gains in the knowledge of CSA concepts and skills over a 12-month follow-up period. Girls had significantly greater CSA knowledge than boys immediately after the intervention, with gender remaining significant even when accounting for level-3 variables. Older children had better knowledge scores at post-test, but growth over time results revealed that younger students made greater gains. For students in 2nd through 4th grade, CI was more important for post-test outcomes, while for all students, CI and grade taught were important to post-test scores. Teachers of lower grades had students with a faster growth rate on correct responses to vignettes. Implications for CSA prevention programming and future research are discussed.",2020,"Older children had better knowledge scores at post-test, but growth over time results revealed that younger students made greater gains.","['Older children', '1132 students and 57 teachers from four elementary schools enrolled', 'students participating in the Second Step Child Protection Unit (CPU']",['CPU'],"['Student Knowledge Gain', 'knowledge scores', 'CSA knowledge', 'Content Integrity (CI; adherence to content), Process Integrity (PI; teacher enthusiasm, encouragement, behavior management), and Dose Received (DR; student behavior and interest']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0337542', 'cui_str': 'Stepchild'}, {'cui': 'C0439148', 'cui_str': 'Unit'}]",[],"[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0008062', 'cui_str': 'Sexual Abuse of Child'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0424090', 'cui_str': 'Level of interest'}, {'cui': 'C0150143', 'cui_str': 'Behavior management'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0543488', 'cui_str': 'Interested'}]",1132.0,0.0133982,"Older children had better knowledge scores at post-test, but growth over time results revealed that younger students made greater gains.","[{'ForeName': 'Margaret E', 'Initials': 'ME', 'LastName': 'Manges', 'Affiliation': 'Alberti Center for Bullying Abuse Prevention, The University at Buffalo, State University of New York, 428 Baldy Hall, Buffalo, NY, 14260-1000, USA. memanges@buffalo.edu.'}, {'ForeName': 'Amanda B', 'Initials': 'AB', 'LastName': 'Nickerson', 'Affiliation': 'Alberti Center for Bullying Abuse Prevention, The University at Buffalo, State University of New York, 428 Baldy Hall, Buffalo, NY, 14260-1000, USA.'}]",Prevention science : the official journal of the Society for Prevention Research,['10.1007/s11121-020-01146-y']
2309,32689601,Can robotic gait rehabilitation plus Virtual Reality affect cognitive and behavioural outcomes in patients with chronic stroke? A randomized controlled trial involving three different protocols.,"BACKGROUND


The rehabilitation of cognitive and behavioral abnormalities in individuals with stroke is essential for promoting patient's recovery and autonomy. The aim of our study is to evaluate the effects of robotic neurorehabilitation using Lokomat with and without VR on cognitive functioning and psychological well-being in stroke patients, as compared to traditional therapy.
METHODS


Ninety stroke patients were included in this randomized controlled clinical trial. The patients were assigned to one of the three treatment groups, i.e. the Robotic Rehabilitation group undergoing robotic rehab with VR (RRG+VR), the Robotic Rehabilitation Group (RRG-VR) using robotics without VR, and the Conventional Rehabilitation group (CRG) submitted to conventional physiotherapy and cognitive treatment.
RESULTS


The analysis showed that either the robotic training (with and without VR) or the conventional rehabilitation led to significant improvements in the global cognitive functioning, mood, and executive functions, as well as in activities of daily living. However, only in the RRG+VR we observed a significant improvement in cognitive flexibility and shifting skills, selective attention/visual research, and quality of life, with regard to the perception of the mental and physical state.
CONCLUSION


Our study shows that robotic treatment, especially if associated with VR, may positively affect cognitive recovery and psychological well-being in patients with chronic stroke, thanks to the complex interation between movement and cognition.",2020,"However, only in the RRG+VR we observed a significant improvement in cognitive flexibility and shifting skills, selective attention/visual research, and quality of life, with regard to the perception of the mental and physical state.
","['stroke patients', 'Ninety stroke patients', 'individuals with stroke', 'patients with chronic stroke']","['robotic gait rehabilitation plus Virtual Reality', 'robotic training (with and without VR', 'robotic neurorehabilitation using Lokomat with and without VR', 'Robotic Rehabilitation group undergoing robotic rehab with VR (RRG+VR), the Robotic Rehabilitation Group (RRG-VR) using robotics without VR, and the Conventional Rehabilitation group (CRG) submitted to conventional physiotherapy and cognitive treatment']","['cognitive flexibility and shifting skills, selective attention/visual research, and quality of life, with regard to the perception of the mental and physical state', 'global cognitive functioning, mood, and executive functions, as well as in activities of daily living']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}]","[{'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0204096', 'cui_str': 'Neurological rehabilitation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0233421', 'cui_str': 'Selective inattention'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0597240', 'cui_str': 'State of matter'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}]",90.0,0.0238372,"However, only in the RRG+VR we observed a significant improvement in cognitive flexibility and shifting skills, selective attention/visual research, and quality of life, with regard to the perception of the mental and physical state.
","[{'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Manuli', 'Affiliation': 'IRCCS Centro Neurolesi ""Bonino Pulejo"", Messina, Italy. Electronic address: alfredo.manuli@irccsme.it.'}, {'ForeName': 'Maria Grazia', 'Initials': 'MG', 'LastName': 'Maggio', 'Affiliation': 'IRCCS Centro Neurolesi ""Bonino Pulejo"", Messina, Italy. Electronic address: mariagrazia.maggio@irccsme.it.'}, {'ForeName': 'Desiree', 'Initials': 'D', 'LastName': 'Latella', 'Affiliation': 'IRCCS Centro Neurolesi ""Bonino Pulejo"", Messina, Italy. Electronic address: desiree.latella@irccsme.it.'}, {'ForeName': 'Antonino', 'Initials': 'A', 'LastName': 'Cannavò', 'Affiliation': 'IRCCS Centro Neurolesi ""Bonino Pulejo"", Messina, Italy. Electronic address: an.cannavo@irccsme.it.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Balletta', 'Affiliation': 'IRCCS Centro Neurolesi ""Bonino Pulejo"", Messina, Italy. Electronic address: tina.balletta@irccsme.it.'}, {'ForeName': 'Rosaria', 'Initials': 'R', 'LastName': 'De Luca', 'Affiliation': 'IRCCS Centro Neurolesi ""Bonino Pulejo"", Messina, Italy. Electronic address: dlucaros@yahoo.it.'}, {'ForeName': 'Antonino', 'Initials': 'A', 'LastName': 'Naro', 'Affiliation': 'IRCCS Centro Neurolesi ""Bonino Pulejo"", Messina, Italy. Electronic address: antonino.naro@irccsme.it.'}, {'ForeName': 'Rocco Salvatore', 'Initials': 'RS', 'LastName': 'Calabrò', 'Affiliation': 'IRCCS Centro Neurolesi ""Bonino Pulejo"", Messina, Italy. Electronic address: salbro77@tiscali.it.'}]",Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association,['10.1016/j.jstrokecerebrovasdis.2020.104994']
2310,32690406,"Comparison the effect of breast milk smell, white noise and facilitated tucking applied to Turkish preterm infants during endotracheal suctioning on pain and physiological parameters.","PURPOSE


This study aimed to determine the effect of the breast milk smell, white noise and facilitated tucking during endotracheal suctioning (ES) on pain and physiological findings.
DESIGN AND METHODS


The present study was conducted as a randomized, controlled experimental trial study. The sample of the study was composed of a total of 80 preterm infants. Pain was measured with PIPP-R pain scale. rMANOVA and bonferroni tests were used in the comparison of the pain scores of the groups.
RESULTS


It was determined that white noise and facilitated tucking were more effective in relieving infants before ES procedure (p < .05). No statistically significant difference was found between the groups in reducing the pain during ES procedure (p > .05). After the procedure, facilitated tucking was determined more effective in the recovery of preterm infants (p < .05).
PRACTICE IMPLICATIONS


It is recommended to use facilitated tucking and white noise for decreasing pain of ventilated preterm infants during the ES procedure.
CONCLUSIONS


White noise and facilitated tucking were effective in relieving pain before procedure and facilitated tucking recovery in preterm infants after the ES procedure.",2020,"After the procedure, facilitated tucking was determined more effective in the recovery of preterm infants (p < .05).
","['ventilated preterm infants during the ES procedure', '80 preterm infants']","['endotracheal suctioning', 'breast milk smell, white noise and facilitated tucking during endotracheal suctioning (ES', 'breast milk smell, white noise and facilitated tucking']","['pain scores', 'pain and physiological findings', 'Pain', 'pain and physiological parameters', 'pain during ES procedure', 'relieving pain', 'PIPP-R pain scale']","[{'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C1522653', 'cui_str': 'Intratracheal route'}, {'cui': 'C0038638', 'cui_str': 'Suction drainage'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C1522653', 'cui_str': 'Intratracheal route'}, {'cui': 'C0038638', 'cui_str': 'Suction drainage'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0037361', 'cui_str': 'Sense of smell, function'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0028263', 'cui_str': 'Noise'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1522653', 'cui_str': 'Intratracheal route'}, {'cui': 'C0038638', 'cui_str': 'Suction drainage'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0070798', 'cui_str': 'PtdIns(4,5)P2'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}]",80.0,0.0401671,"After the procedure, facilitated tucking was determined more effective in the recovery of preterm infants (p < .05).
","[{'ForeName': 'Ayşe Şener', 'Initials': 'AŞ', 'LastName': 'Taplak', 'Affiliation': 'PhD, Assist. Prof, RN. Yozgat Bozok University, Faculty of Health Sciences, Yozgat, Turkey. Electronic address: ayse.taplak@yobu.edu.tr.'}, {'ForeName': 'Meral', 'Initials': 'M', 'LastName': 'Bayat', 'Affiliation': 'PhD, Prof, RN. Erciyes University Faculty of Health Sciences, Kayseri, Turkey.'}]",Journal of pediatric nursing,['10.1016/j.pedn.2020.07.001']
2311,32691121,"Letter to the editor regarding ""Safety of one-stage bilateral total knee arthroplasty -one surgeon sequential vs. two surgeons simultaneous: a randomized controlled study"".",,2020,,[],['bilateral total knee arthroplasty -one surgeon sequential vs. two surgeons simultaneous'],[],[],"[{'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}]",[],,0.0740354,,"[{'ForeName': 'Tomonori', 'Initials': 'T', 'LastName': 'Shigemura', 'Affiliation': 'Department of Orthopaedic Surgery, Teikyo University Chiba Medical Center, 3426-3 Anesaki, Ichihara, Chiba, 299-0111, Japan. tshigepon@yahoo.co.jp.'}, {'ForeName': 'Yohei', 'Initials': 'Y', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Orthopaedic Surgery, Teikyo University Chiba Medical Center, 3426-3 Anesaki, Ichihara, Chiba, 299-0111, Japan.'}, {'ForeName': 'Yuichi', 'Initials': 'Y', 'LastName': 'Wada', 'Affiliation': 'Department of Orthopaedic Surgery, Teikyo University Chiba Medical Center, 3426-3 Anesaki, Ichihara, Chiba, 299-0111, Japan.'}]",International orthopaedics,['10.1007/s00264-020-04744-1']
2312,32696603,Differential Effects of High- and Low-Arousal Positive Emotions on Help-Seeking for Depression.,"BACKGROUND


The current set of pre-registered studies tested the effect of savoring a high-arousal (exciting) or low-arousal (calm) positive experience on help-seeking intentions among people with heightened depressive symptomatology.
METHODS


Across all three studies, participants with heightened depressive symptomatology who had not yet sought help were randomly assigned to complete a 6-minute writing task where they reflected on an exciting memory, a calm memory, or what they did today and yesterday.
RESULTS


Savoring an exciting memory was associated with significantly greater arousal than savoring a calm memory and the control condition (Study 1; N = 218). Both savoring conditions were associated with greater positive emotion than the control condition (Study 2; N = 193). In Study 3 (N = 1,238), savoring an exciting memory, when compared to the control condition, increased help-seeking intentions, whereas savoring a calm memory did not.
CONCLUSIONS


The current studies support the use of high-arousal, rather than low-arousal, positive emotions to increase help-seeking intentions among people with depression.",2020,"In Study 3 (N = 1,238), savoring an exciting memory, when compared to the control condition, increased help-seeking intentions, whereas savoring a calm memory did not.
","['participants with heightened depressive symptomatology who had not yet sought help', 'people with heightened depressive symptomatology', 'people with depression']","['High- and Low-Arousal Positive Emotions', 'savoring a high-arousal (exciting) or low-arousal (calm) positive experience']","['positive emotion', 'help-seeking intentions']","[{'cui': 'C0442803', 'cui_str': 'Heightened'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0162425', 'cui_str': 'Intention'}]",,0.14009,"In Study 3 (N = 1,238), savoring an exciting memory, when compared to the control condition, increased help-seeking intentions, whereas savoring a calm memory did not.
","[{'ForeName': 'Tasha', 'Initials': 'T', 'LastName': 'Straszewski', 'Affiliation': 'Claremont Graduate University, Claremont, USA.'}, {'ForeName': 'Jason T', 'Initials': 'JT', 'LastName': 'Siegel', 'Affiliation': 'Claremont Graduate University, Claremont, USA.'}]",Applied psychology. Health and well-being,['10.1111/aphw.12214']
2313,32696120,Effectiveness of an Educational Video in Maternity Wards to Prevent Self-Reported Shaking and Smothering during the First Week of Age: A Cluster Randomized Controlled Trial.,"This study aimed to investigate whether watching an educational video on infant crying and the dangers of shaking and smothering within 1 week after delivery at maternity wards reduces self-reported shaking and smothering, at a 1-month health checkup. A cluster randomized controlled trial, stratified by area and hospital function, was employed in 45 obstetrics hospitals/clinics in Osaka Prefecture, Japan. In the intervention group, mothers watched an educational video on infant crying and the dangers of shaking and smothering an infant, within 1 week of age, during hospitalization at maternity wards, without blinding on group allocation. Control group received usual care. A total of 4722 (N = 2350 and 2372 for intervention and control group, respectively) mothers who delivered their babies (still birth and gestational age < 22 weeks were excluded) between October 1, 2014, and January 31 were recruited. Outcomes were self-reported shaking and smothering behaviors, knowledge on infant crying and shaking, and behaviors to cope with infant crying, assessed via a questionnaire at a 1-month health checkup. In all, 2718 (N = 1078 and 1640) responded to the questionnaire (response rate: 58.3%), and analytic sample size was 2655 (N = 1058 and 1597 for intervention and control group, respectively). Multilevel analysis was used to adjust for correlation within the cluster. Prevalence of shaking was significantly lower in the intervention group (0.19%) than in the control group (1.69%). Intention-to-treat analysis showed an 89% reduction in the reported prevalence of self-reported shaking (OR: 0.11, 95% CI: 0.02-0.53) due to watching the educational video. However, self-reported smothering behavior showed no significant reduction (OR: 0.66, 95% CI: 0.27-1.60). No side effects were reported. Watching an educational video on infant crying and the dangers of shaking and smothering within 1 week after delivery at maternity wards reduced self-reported shaking at 1 month of age. UMIN Clinical Trial Registry UMIN000015558.",2020,Prevalence of shaking was significantly lower in the intervention group (0.19%) than in the control group (1.69%).,"['45 obstetrics hospitals/clinics in Osaka Prefecture, Japan', 'Maternity Wards to Prevent Self-Reported Shaking and Smothering during the First Week of Age', 'A total of 4722 (N\u2009=\u20092350 and 2372 for intervention and control group, respectively) mothers who delivered their babies (still birth and gestational age\u2009<\u200922\xa0weeks were excluded) between October 1, 2014, and January 31 were recruited']","['mothers watched an educational video', 'usual care', 'Educational Video', 'watching an educational video', 'Watching an educational video']","['Prevalence of shaking', 'self-reported shaking and smothering behaviors, knowledge on infant crying and shaking, and behaviors to cope with infant crying, assessed via a questionnaire at a 1-month health checkup']","[{'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0040822', 'cui_str': 'Tremor'}, {'cui': 'C0277619', 'cui_str': 'Traumatic asphyxiation'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0595939', 'cui_str': 'Stillbirth'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0042655', 'cui_str': 'Video'}]","[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0040822', 'cui_str': 'Tremor'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0277619', 'cui_str': 'Traumatic asphyxiation'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0581876', 'cui_str': 'Crying infant'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0260860', 'cui_str': 'General medical examination'}]",4722.0,0.0869133,Prevalence of shaking was significantly lower in the intervention group (0.19%) than in the control group (1.69%).,"[{'ForeName': 'Takeo', 'Initials': 'T', 'LastName': 'Fujiwara', 'Affiliation': 'Department of Global Health Promotion, Tokyo Medical and Dental University, 1-5-45, Yushima, Bunkyo-ku, Tokyo, 113-8519, Japan. fujiwara.hlth@tmd.ac.jp.'}, {'ForeName': 'Aya', 'Initials': 'A', 'LastName': 'Isumi', 'Affiliation': 'Department of Global Health Promotion, Tokyo Medical and Dental University, 1-5-45, Yushima, Bunkyo-ku, Tokyo, 113-8519, Japan.'}, {'ForeName': 'Makiko', 'Initials': 'M', 'LastName': 'Sampei', 'Affiliation': 'Department of Global Health Promotion, Tokyo Medical and Dental University, 1-5-45, Yushima, Bunkyo-ku, Tokyo, 113-8519, Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Miyazaki', 'Affiliation': 'Department of Systems and Control Engineering, Tokyo Institute of Technology, Tokyo, Japan.'}, {'ForeName': 'Fujiko', 'Initials': 'F', 'LastName': 'Yamada', 'Affiliation': 'Department of Global Health Promotion, Tokyo Medical and Dental University, 1-5-45, Yushima, Bunkyo-ku, Tokyo, 113-8519, Japan.'}, {'ForeName': 'Hisashi', 'Initials': 'H', 'LastName': 'Noma', 'Affiliation': 'Department of Data Science, The Institute of Statistical Mathematics, Tokyo, Japan.'}, {'ForeName': 'Kazuhide', 'Initials': 'K', 'LastName': 'Ogita', 'Affiliation': 'Department of Obstetrics and Gynecology, Rinku General Medical Center, Osaka, Japan.'}, {'ForeName': 'Nobuaki', 'Initials': 'N', 'LastName': 'Mitsuda', 'Affiliation': 'Department of Obstetrics, Osaka Medical Center and Research Institute for Maternal and Child Health, Osaka, Japan.'}]",Prevention science : the official journal of the Society for Prevention Research,['10.1007/s11121-020-01145-z']
2314,32559335,Phase II Study of Low-Dose Afatinib Maintenance Treatment Among Patients with EGFR-Mutated Non-Small Cell Lung Cancer: North Japan Lung Cancer Study Group Trial 1601 (NJLCG1601).,"LESSONS LEARNED


Low-dose afatinib maintenance treatment among patients with EGFR-mutated NSCLC achieved long-time to treatment failure with fewer treatment-related AEs without detracting from the therapeutic efficacy. This modified regimen represents a practical usage that balances effectiveness and safety.
BACKGROUND


Although afatinib is an effective therapy for patients with EGFR-mutated non-small cell lung cancer (NSCLC), drug-related adverse events (AEs) have often necessitated dose reductions. In a post hoc analysis of the LUX-Lung 3 and 6 trials, there was no difference in median progression-free survival (PFS) between patients who had the dose of afatinib reduced and those who did not. We thus evaluated the efficacy and tolerability of low-dose afatinib maintenance treatment among patients with NSCLC harboring EGFR mutations who had not been previously treated.
METHODS


Eligible patients received afatinib 40 mg orally once daily. When prescribed grade ≥ 2 AEs, rash of grade ≥ 3, or unacceptable toxicity occurred, the afatinib dose was reduced from 40 to 30 mg and if needed from 30 to 20 mg. The primary endpoint was the 1-year PFS rate. Secondary endpoints were PFS, overall response rate (ORR), and toxicity.
RESULTS


Among 30 patients, 93% had adenocarcinoma, 53% had exon 19 deletion, 37% had L858R, and 10% had minor mutations. The 1-year PFS rate was 50% (95% confidence interval [CI], 31.3-66.1) and the median PFS was 11.8 months (95% CI, 7.1-21.4). The incidence rate of grade ≥ 3 toxicities was 57%, including elevated aspartate aminotransferase/alanine aminotransferase level (13%), diarrhea (10%), and paronychia (10%).
CONCLUSION


Low-dose afatinib maintenance treatment reduced treatment-related AEs without detracting from the therapeutic efficacy.",2020,"The 1-year PFS rate was 50% (95% confidence interval [CI], 31.3-66.1) and the median PFS was 11.8 months (95% CI, 7.1-21.4).","['Eligible patients received', 'patients with EGFR-mutated non-small cell lung cancer (NSCLC', 'patients with EGFR-mutated NSCLC', 'Patients with EGFR-Mutated Non-Small Cell Lung Cancer', 'patients with NSCLC harboring EGFR mutations who had not been previously treated']","['afatinib 40 mg orally once daily', 'Low-Dose Afatinib Maintenance Treatment']","['diarrhea', 'incidence rate of grade ≥\u20093 toxicities', 'paronychia', '1-year PFS rate', 'PFS, overall response rate (ORR), and toxicity', 'elevated aspartate aminotransferase/alanine aminotransferase level', 'efficacy and tolerability', 'median progression-free survival (PFS', 'unacceptable toxicity', 'median PFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0475311', 'cui_str': 'Harbor'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C3652037', 'cui_str': 'Afatinib 40 MG [Gilotrif]'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C2987648', 'cui_str': 'Afatinib'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0030578', 'cui_str': 'Paronychia'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",,0.240061,"The 1-year PFS rate was 50% (95% confidence interval [CI], 31.3-66.1) and the median PFS was 11.8 months (95% CI, 7.1-21.4).","[{'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Nakamura', 'Affiliation': 'Department of Pulmonary Medicine, Sendai Kousei Hospital, Sendai, Japan.'}, {'ForeName': 'Hisashi', 'Initials': 'H', 'LastName': 'Tanaka', 'Affiliation': 'Department of Respiratory Medicine, Hirosaki University, Hirosaki, Japan.'}, {'ForeName': 'Ryota', 'Initials': 'R', 'LastName': 'Saito', 'Affiliation': 'Department of Respiratory Medicine, Tohoku University Hospital, Sendai, Japan.'}, {'ForeName': 'Aya', 'Initials': 'A', 'LastName': 'Suzuki', 'Affiliation': 'Department of Respiratory Medicine, Miyagi Cancer Center, Natori, Japan.'}, {'ForeName': 'Toshiyuki', 'Initials': 'T', 'LastName': 'Harada', 'Affiliation': 'Department of Respiratory Medicine, JCHO Hokkaido Hospital, Sapporo, Japan.'}, {'ForeName': 'Sumito', 'Initials': 'S', 'LastName': 'Inoue', 'Affiliation': 'Department of Cardiology, Pulmonology, and Nephrology, Yamagata University Faculty of Medicine, Yamagata, Japan.'}, {'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Yamada', 'Affiliation': 'First Department of Internal Medicine, Toyama University Hospital, Toyama, Japan.'}, {'ForeName': 'Taku', 'Initials': 'T', 'LastName': 'Nakagawa', 'Affiliation': 'Dapartment of Thoracic Surgery, Omagari Kosei Medical Center, Daisen, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Jingu', 'Affiliation': 'Department of Respiratory Medicine, Saka General Hospital, Shiogama, Japan.'}, {'ForeName': 'Shunichi', 'Initials': 'S', 'LastName': 'Sugawara', 'Affiliation': 'Department of Pulmonary Medicine, Sendai Kousei Hospital, Sendai, Japan.'}]",The oncologist,['10.1634/theoncologist.2020-0545']
2315,32693116,Topical therapy with rhubarb navel plasters in patients with chronic constipation: Results from a prospective randomized multicenter study.,"ETHNOPHARMACOLOGICAL RELEVANCE


Constipation is a functional gastrointestinal disorder and one of the most prevalent conditions encountered in primary care settings. Rhubarb navel dressings have been used for more than 2,000 years in Chinese medicine to treat constipation. However, the effect of topical rhubarb administration has still not been well recognized and this strategy is not yet established as an evidence-based approach.
AIM OF THE STUDY


In this study, we performed a prospective multicentric randomized controlled trial to evaluate the efficacy and safety of rhubarb navel plasters for patients with chronic constipation.
MATERIALS AND METHODS


A total of 374 patients from six teaching hospitals were prospectively included between 09/2016 and 10/2017 in the study based on Rome III criteria. All participants were randomly assigned (1:1) into verum/placebo group and given either Rheum officinale rhubarb powder or a placebo flour stick on the navel for 6 h/day/8 days. Primary outcome measures were the Cleveland Constipation Score (CCS) for the feces condition and Bristol Stool Scale (BSS) for stool consistency and 24 h defecation frequency.
RESULTS


The groups demonstrated no statistical differences in demographic data, clinical diagnoses and concomitant medication at baseline. In patients treated with the verum CCS was 5.61 (day 8, 95% CI 5.15-6.07) compared to 8.62 (95% CI 8.07-9.18) in placebo-treated controls (P < 0.001). The mean change of CCS at the end of treatment (day 8 versus [vs] day 0) was 6.04 in verum-treated vs 2.73 in placebo-treated controls (P < 0.001). Also 24 h defecation frequency (BSS) showed superior results (day 5: 0.84 vs 0.62, 95% CI 0.67-0.80, P < 0.001; day 6: 0.82 vs 0.60, 95% CI 0.64-0.78, P < 0.01 and day 8: 0.82 vs 0.60, 95% CI 0.64-0.78, P < 0.01) and better BSS type classification during treatment than controls (P < 0.05). No significant differences in adverse events between both groups became obvious.
CONCLUSION


Rhubarb navel plaster administration over an 8-day-treatment period resulted in significantly improved bowel function as demonstrated by the CCS, 24 h defecating frequency and BSS. Our results suggest that rhubarb navel plasters represent a feasible, safe and efficient application route for the treatment of patients suffering from chronic constipation.",2020,"Also 24 h defecation frequency (BSS) showed superior results (day 5: 0.84 vs 0.62, 95% CI 0.67-0.80, P < 0.001; day 6: 0.82 vs 0.60, 95% CI 0.64-0.78, P < 0.01 and day 8: 0.82 vs 0.60, 95% CI 0.64-0.78, P < 0.01) and better BSS type classification during treatment than controls (P < 0.05).","['patients with chronic constipation', 'patients suffering from chronic constipation', '374 patients from six teaching hospitals were prospectively included between 09/2016 and 10/2017 in the study based on Rome III criteria']","['verum/placebo group and given either Rheum officinale rhubarb powder or a placebo flour stick', 'Rhubarb navel dressings', 'Topical therapy', 'rhubarb navel plasters', 'verum CCS']","['demographic data, clinical diagnoses and concomitant medication', 'bowel function', 'BSS type classification', 'efficacy and safety', 'adverse events', 'defecation frequency (BSS', 'Cleveland Constipation Score (CCS) for the feces condition and Bristol Stool Scale (BSS) for stool consistency and 24\u202fh defecation frequency', 'mean change of CCS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0401149', 'cui_str': 'Chronic constipation'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0035509', 'cui_str': 'Rhubarb'}, {'cui': 'C1815861', 'cui_str': 'Rhubarb powder'}, {'cui': 'C0016260', 'cui_str': 'Flour'}, {'cui': 'C1706582', 'cui_str': 'Stick'}, {'cui': 'C0041638', 'cui_str': 'Umbilical structure'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0460977', 'cui_str': 'Plasters'}, {'cui': 'C0454845', 'cui_str': 'Cleveland'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0457570', 'cui_str': 'Scale type'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0454845', 'cui_str': 'Cleveland'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0426740', 'cui_str': 'Consistency of stool'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",374.0,0.207116,"Also 24 h defecation frequency (BSS) showed superior results (day 5: 0.84 vs 0.62, 95% CI 0.67-0.80, P < 0.001; day 6: 0.82 vs 0.60, 95% CI 0.64-0.78, P < 0.01 and day 8: 0.82 vs 0.60, 95% CI 0.64-0.78, P < 0.01) and better BSS type classification during treatment than controls (P < 0.05).","[{'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Wei', 'Affiliation': 'The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.. Electronic address: weilin22@126.com.'}, {'ForeName': 'Yueming', 'Initials': 'Y', 'LastName': 'Luo', 'Affiliation': 'The fourth Clinical Medical College of Guangzhou University of Chinese Medicine, Shenzhen Traditional Chinese Medicine Hospital, Shenzhen, China. Electronic address: 314851488@qq.com.'}, {'ForeName': 'Xiaopei', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.. Electronic address: xingyunxing021@163.com.'}, {'ForeName': 'Yangchen', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.. Electronic address: morning924@126.com.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Gasser', 'Affiliation': 'University of Wuerzburg, Wuerzburg, Germany. Electronic address: gasser_m@t-online.de.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Tang', 'Affiliation': 'The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.. Electronic address: tangtang56love@126.com.'}, {'ForeName': 'Wen-Wei', 'Initials': 'WW', 'LastName': 'Ouyang', 'Affiliation': 'The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.. Electronic address: yudexin1984@163.com.'}, {'ForeName': 'Hengqiu', 'Initials': 'H', 'LastName': 'Wei', 'Affiliation': 'The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China. Electronic address: 1131968978@qq.com.'}, {'ForeName': 'Shengzhen', 'Initials': 'S', 'LastName': 'Lu', 'Affiliation': 'Jiangxi Integrated Traditional Chinese and Western Medicine Hospital, Nanchang, China. Electronic address: 982121880@qq.com.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'The First Affiliated Hospital of Nanchang University, Nanchang, China. Electronic address: 64243156@qq.com.'}, {'ForeName': 'Ana Maria', 'Initials': 'AM', 'LastName': 'Waaga-Gasser', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA. Electronic address: awaaga@bwh.harvard.edu.""}, {'ForeName': 'Chong', 'Initials': 'C', 'LastName': 'Deng', 'Affiliation': 'Guangzhou University of Traditional Chinese Medicine, Guangzhou, China. Electronic address: gzdtcm@gzucm.edu.cn.'}, {'ForeName': 'Meizhen', 'Initials': 'M', 'LastName': 'Lin', 'Affiliation': 'The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.. Electronic address: linmeizhen@gzucm.edu.cn.'}]",Journal of ethnopharmacology,['10.1016/j.jep.2020.113096']
2316,32693185,"Efficacy and Safety of Tradipitant in Patients With Diabetic and Idiopathic Gastroparesis in a Randomized, Placebo-Controlled Trial.","BACKGROUND & AIMS


Treatments are needed for gastroparesis; antagonists of tachykinin receptor 1 (TACR1, also called NK1R) can reduce symptoms of nausea and vomiting. We investigated the safety and efficacy of tradipitant, an antagonist of NK1R, in patients with idiopathic or diabetic gastroparesis.
METHODS


We performed a double-blind trial of 152 adults with gastroparesis at 47 sites in the United States from November 2016 through December 2018. Participants were randomly assigned to groups given oral tradipitant 85 mg (n = 77) or placebo (n = 75) twice daily for 4 weeks. Symptoms were assessed by a daily symptom dairy, Gastroparesis Cardinal Symptom Index scores, and other patient-reported questionnaires. The primary outcome from the intent-to-treat analysis was change from baseline to week 4 in average nausea severity, measured by the Gastroparesis Core Symptom Daily Diary.
RESULTS


Patients receiving tradipitant had a significant decrease in nausea score (reduction of 1.2) at week 4 compared with placebo (reduction of 0.7) (P = .0099) and a significant increase in of nausea-free days at week 4 (28.8% increase on tradipitant vs 15.0% on placebo; P = .0160). Patients with nausea and vomiting at baseline (n = 101) had an even greater decrease in nausea in when given tradipitant (reduction of 1.4) compared with those given placebo (reduction of 0.4) (P < .0001), as well as an increase in nausea-free days at week 4 (32.3% improvement on tradipitant vs 7.6% on placebo; P = .0003). The average nausea score was 1 or less at week 4 in 32.9% of patients given tradipitant compared with 11.8% of patients given placebo (P = .0013). A greater than 1-point improvement in Gastroparesis Cardinal Symptom Index score was observed in 46.6% of patients given tradipitant compared with 23.5% of patients given placebo (P = .0053).
CONCLUSIONS


Tradipitant resulted in statistically and clinically meaningful improvements in nausea and reduced vomiting, compared with placebo, in patients with idiopathic or diabetic gastroparesis. ClinicalTrials.gov, Number: NCT02970968.",2020,"RESULTS


Patients receiving tradipitant had a significant decrease in nausea score (reduction of 1.2) at week 4 compared with placebo (reduction of 0.7) (P=.0099), and a significant increase in of nausea-free days at week 4 (28.8% increase on tradipitant vs 15.0% on placebo; P=.0160).","['patients with idiopathic or diabetic gastroparesis', 'Patients with Diabetic and Idiopathic Gastroparesis', '152 adults with gastroparesis at 47 sites in the United States from November 2016 through December 2018']","['oral tradipitant', 'Tradipitant', 'Placebo', 'placebo']","['Efficacy and Safety', 'nausea-free days', 'gastroparesis cardinal symptom index score', 'daily symptom dairy, gastroparesis cardinal symptom index scores', 'Average nausea score', 'nausea and vomiting', 'nausea and reduced vomiting', 'average nausea severity, measured by the gastroparesis core symptom daily diary', 'safety and efficacy', 'nausea', 'nausea score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0267176', 'cui_str': 'Gastroparesis with diabetes mellitus'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0859972', 'cui_str': 'Idiopathic gastroparesis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0152020', 'cui_str': 'Gastroparesis syndrome'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0152020', 'cui_str': 'Gastroparesis syndrome'}, {'cui': 'C0326926', 'cui_str': 'Cardinalis cardinalis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}]",152.0,0.491972,"RESULTS


Patients receiving tradipitant had a significant decrease in nausea score (reduction of 1.2) at week 4 compared with placebo (reduction of 0.7) (P=.0099), and a significant increase in of nausea-free days at week 4 (28.8% increase on tradipitant vs 15.0% on placebo; P=.0160).","[{'ForeName': 'Jesse L', 'Initials': 'JL', 'LastName': 'Carlin', 'Affiliation': 'Vanda Pharmaceuticals, Inc, Washington, DC. Electronic address: Jesse.Carlin@vandapharma.com.'}, {'ForeName': 'V Rose', 'Initials': 'VR', 'LastName': 'Lieberman', 'Affiliation': 'Vanda Pharmaceuticals, Inc, Washington, DC.'}, {'ForeName': 'Arya', 'Initials': 'A', 'LastName': 'Dahal', 'Affiliation': 'Vanda Pharmaceuticals, Inc, Washington, DC.'}, {'ForeName': 'Madison S', 'Initials': 'MS', 'LastName': 'Keefe', 'Affiliation': 'Vanda Pharmaceuticals, Inc, Washington, DC.'}, {'ForeName': 'Changfu', 'Initials': 'C', 'LastName': 'Xiao', 'Affiliation': 'Vanda Pharmaceuticals, Inc, Washington, DC.'}, {'ForeName': 'Gunther', 'Initials': 'G', 'LastName': 'Birznieks', 'Affiliation': 'Vanda Pharmaceuticals, Inc, Washington, DC.'}, {'ForeName': 'Thomas L', 'Initials': 'TL', 'LastName': 'Abell', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, Department of Internal Medicine, University of Louisville, Louisville, Kentucky.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Lembo', 'Affiliation': 'Division of Gastroenterology, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Henry P', 'Initials': 'HP', 'LastName': 'Parkman', 'Affiliation': 'Department of Medicine, Temple University School of Medicine, Philadelphia, Pennsylvania.'}, {'ForeName': 'Mihael H', 'Initials': 'MH', 'LastName': 'Polymeropoulos', 'Affiliation': 'Vanda Pharmaceuticals, Inc, Washington, DC.'}]",Gastroenterology,['10.1053/j.gastro.2020.07.029']
2317,31897428,Blocking FcRn in humans reduces circulating IgG levels and inhibits IgG immune complex-mediated immune responses.,"The neonatal crystallizable fragment receptor (FcRn) functions as an intracellular protection receptor for immunoglobulin G (IgG). Recently, several clinical studies have reported the lowering of circulating monomeric IgG levels through FcRn blockade for the potential treatment of autoimmune diseases. Many autoimmune diseases, however, are derived from the effects of IgG immune complexes (ICs). We generated, characterized, and assessed the effects of SYNT001, a FcRn-blocking monoclonal antibody, in mice, nonhuman primates (NHPs), and humans. SYNT001 decreased all IgG subtypes and IgG ICs in the circulation of humans, as we show in a first-in-human phase 1, single ascending dose study. In addition, IgG IC induction of inflammatory pathways was dependent on FcRn and inhibited by SYNT001. These studies expand the role of FcRn in humans by showing that it controls not only IgG protection from catabolism but also inflammatory pathways associated with IgG ICs involved in a variety of autoimmune diseases.",2019,"We generated, characterized, and assessed the effects of SYNT001, a FcRn-blocking monoclonal antibody, in mice, nonhuman primates (NHPs), and humans.",[],[],['IgG subtypes and IgG ICs'],[],[],"[{'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0449560', 'cui_str': 'Subtype'}, {'cui': 'C0003313', 'cui_str': 'Immune complex'}]",,0.0359691,"We generated, characterized, and assessed the effects of SYNT001, a FcRn-blocking monoclonal antibody, in mice, nonhuman primates (NHPs), and humans.","[{'ForeName': 'L J', 'Initials': 'LJ', 'LastName': 'Blumberg', 'Affiliation': 'Syntimmune Inc., Boston, MA 02116, USA.'}, {'ForeName': 'J E', 'Initials': 'JE', 'LastName': 'Humphries', 'Affiliation': 'Biologics Consulting, Alexandria, VA 22314, USA.'}, {'ForeName': 'S D', 'Initials': 'SD', 'LastName': 'Jones', 'Affiliation': 'BioProcess Technology Consultants, Woburn, MA 01801, USA.'}, {'ForeName': 'L B', 'Initials': 'LB', 'LastName': 'Pearce', 'Affiliation': 'Biologics Consulting, Alexandria, VA 22314, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Holgate', 'Affiliation': 'Abzena, Babraham, Cambridge, CB22 3AT, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Hearn', 'Affiliation': 'Abzena, Babraham, Cambridge, CB22 3AT, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Cheung', 'Affiliation': 'New York Structural Biology Center, New York, NY 10027, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Mahmood', 'Affiliation': 'New York Structural Biology Center, New York, NY 10027, USA.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Del Tito', 'Affiliation': 'Biologics Consulting, Alexandria, VA 22314, USA.'}, {'ForeName': 'J S', 'Initials': 'JS', 'LastName': 'Graydon', 'Affiliation': 'Syntimmune Inc., Boston, MA 02116, USA.'}, {'ForeName': 'L E', 'Initials': 'LE', 'LastName': 'Stolz', 'Affiliation': 'Syntimmune Inc., Boston, MA 02116, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bitonti', 'Affiliation': 'Syntimmune Inc., Boston, MA 02116, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Purohit', 'Affiliation': 'BioProcess Technology Consultants, Woburn, MA 01801, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'de Graaf', 'Affiliation': 'Syntimmune Inc., Boston, MA 02116, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Kacena', 'Affiliation': 'BioBridges, Wellesley, MA 02481, USA.'}, {'ForeName': 'J T', 'Initials': 'JT', 'LastName': 'Andersen', 'Affiliation': 'Department of Immunology and Centre for Immune Regulation, Oslo University Hospital Rikshospitalet and University of Oslo, Oslo 0424, Norway.'}, {'ForeName': 'G J', 'Initials': 'GJ', 'LastName': 'Christianson', 'Affiliation': 'The Jackson Laboratory, Bar Harbor, ME 04609, USA.'}, {'ForeName': 'D C', 'Initials': 'DC', 'LastName': 'Roopenian', 'Affiliation': 'The Jackson Laboratory, Bar Harbor, ME 04609, USA.'}, {'ForeName': 'J J', 'Initials': 'JJ', 'LastName': 'Hubbard', 'Affiliation': ""Department of Medicine, Division of Gastroenterology, Hepatology and Endoscopy, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02115, USA.""}, {'ForeName': 'A K', 'Initials': 'AK', 'LastName': 'Gandhi', 'Affiliation': ""Department of Medicine, Division of Gastroenterology, Hepatology and Endoscopy, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02115, USA.""}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Lasseter', 'Affiliation': 'Clinical Pharmacology of Miami, Miami, FL 33014, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Pyzik', 'Affiliation': ""Department of Medicine, Division of Gastroenterology, Hepatology and Endoscopy, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02115, USA.""}, {'ForeName': 'R S', 'Initials': 'RS', 'LastName': 'Blumberg', 'Affiliation': ""Department of Medicine, Division of Gastroenterology, Hepatology and Endoscopy, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02115, USA.""}]",Science advances,['10.1126/sciadv.aax9586']
2318,32698634,"Effect of oral administration of Triphala, a polyphenol-rich prebiotic, on scalp sebum in patients with scalp seborrhea a randomized clinical trial.","BACKGROUND


Although there are various therapeutic options to control oily skin, they have potential side effects and limitations especially in long-term use. Pre/probiotics may have beneficial effects in atopic dermatitis' acne, dandruff, and seborrhea, demonstrated by some clinical trials. This trial conducted to determine whether the herbal prebiotic Triphala is effective in reducing scalp sebum secretion in patients with scalp seborrhea.
METHODS


In this 8 week patient and outcome assessor-blinded, placebo-controlled trial participants with scalp seborrhea aged 14-50 years were randomized to Triphala or placebo groups. 1 g of Triphala (standardized as 91.82 ± 0.5 mg gallic acid) or placebo (wheat flour) were administered BID. Scalp sebum levels were detected objectively using Sebumeter ®  sm 815, and treatment satisfaction was measured using a score between 0 and 100. [Registration no. IRCT2014070218332N1].
RESULTS


Eighty patients completed the study (40 in Triphala group and 40 in placebo group). Participants in the Triphala group experienced 25.34 scores (95% CI, 0.39-50.29:  p  = .047) more improvement in scalp sebum levels compared with the placebo group. The mean percentage of patients' satisfaction was 37.91 (24.88) in the Triphala group and 17.89 (25.80) in the placebo group ( p  = .001).
CONCLUSION


Herbal prebiotic Triphala significantly reduced scalp sebum scores compared to placebo.",2020,"Participants in the Triphala group experienced 25.34 scores (95% CI, 0.39-50.29:  P  = 0.047) more improvement in scalp sebum levels compared with the placebo group.","['patients with scalp seborrhea', 'Eighty patients completed the study (40 in Triphala group and 40 in placebo group', 'controlled trial participants with scalp seborrhea aged 14-50 years']","['herbal prebiotic Triphala', 'Triphala (standardized as 91.82\u2009±\u20090.5\u2009mg gallic acid) or placebo (wheat flour', 'Triphala, a polyphenol-rich prebiotic', 'Herbal prebiotic Triphala', 'Triphala or placebo', 'placebo']","['scalp sebum secretion', 'scalp sebum scores', 'Scalp sebum levels', 'scalp sebum levels', ""mean percentage of patients' satisfaction""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0221244', 'cui_str': 'Seborrheic dermatitis of scalp'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1958185', 'cui_str': 'triphala'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0376667', 'cui_str': 'Herbals'}, {'cui': 'C2717875', 'cui_str': 'Prebiotics'}, {'cui': 'C1958185', 'cui_str': 'triphala'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0016979', 'cui_str': 'Gallic acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0458980', 'cui_str': 'Wheat flour'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}]","[{'cui': 'C0036270', 'cui_str': 'Scalp structure'}, {'cui': 'C0232436', 'cui_str': 'Sebaceous gland activity'}, {'cui': 'C0036511', 'cui_str': 'Sebum'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",,0.680131,"Participants in the Triphala group experienced 25.34 scores (95% CI, 0.39-50.29:  P  = 0.047) more improvement in scalp sebum levels compared with the placebo group.","[{'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Zareie', 'Affiliation': 'Department of Persian Medicine, School of Persian Medicine, Shahid Sadoughi University of Medical Sciences, Ardakan, Yazd, I. R. Iran.'}, {'ForeName': 'Parvin', 'Initials': 'P', 'LastName': 'Mansouri', 'Affiliation': 'Skin and Stem Cell Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Hosseini', 'Affiliation': 'Center for Research and Training in Skin Diseases and Leprosy (CRTSDL), Tehran University of Medical Sciences (TUMS), Tehran, Iran.'}, {'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Sadeghpour', 'Affiliation': 'School of Persian Medicine, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Laila', 'Initials': 'L', 'LastName': 'Shirbeigi', 'Affiliation': 'Department of Traditional Medicine, School of Persian Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Someyeh', 'Initials': 'S', 'LastName': 'Hejazi', 'Affiliation': 'Skin and Stem Cell Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Emtiazy', 'Affiliation': 'Department of Persian Medicine, School of Persian Medicine, Shahid Sadoughi University of Medical Sciences, Ardakan, Yazd, I. R. Iran.'}]",The Journal of dermatological treatment,['10.1080/09546634.2020.1800568']
2319,32694638,Circulatory and prostatic tissue lipidomic profiles shifts after high-dose atorvastatin use in men with prostate cancer.,"Prostate cancer patients using cholesterol-lowering statins have 30% lower risk of prostate cancer death compared to non-users. The effect is attributed to the inhibition of the mevalonate pathway in prostate cancer cells. Moreover, statin use causes lipoprotein metabolism changes in the serum. Statin effect on serum or intraprostatic lipidome profiles in prostate cancer patients has not been explored. We studied changes in the serum metabolomic and prostatic tissue lipidome after high-dose 80 mg atorvastatin intervention to expose biological mechanisms causing the observed survival benefit. Our randomized, double-blind, placebo-controlled clinical trial consisted of 103 Finnish men with prostate cancer. We observed clear difference in post-intervention serum lipoprotein lipid profiles between the study arms (median classification error 11.7%). The atorvastatin effect on intraprostatic lipid profile was not as clear (median classification error 44.7%), although slightly differing lipid profiles by treatment arm was observed, which became more pronounced in men who used atorvastatin above the median of 27 days (statin group median classification error 27.2%). Atorvastatin lowers lipids important for adaptation for hypoxic microenvironment in the prostate suggesting that prostate cancer cell survival benefit associated with statin use might be mediated by both, local and systemic, lipidomic/metabolomic profile changes.",2020,We observed clear difference in post-intervention serum lipoprotein lipid profiles between the study arms (median classification error 11.7%).,"['Prostate cancer patients using', 'men with prostate cancer', 'prostate cancer patients', '103 Finnish men with prostate cancer']","['atorvastatin', 'atorvastatin intervention', 'Atorvastatin', 'cholesterol-lowering statins', 'placebo']","['post-intervention serum lipoprotein lipid profiles', 'intraprostatic lipid profile', 'prostate cancer death', 'serum metabolomic and prostatic tissue lipidome', 'serum or intraprostatic lipidome profiles']","[{'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0016134', 'cui_str': 'Finnish language'}]","[{'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0023820', 'cui_str': 'Lipoprotein'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C1512969', 'cui_str': 'Intraprostatic route'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1328813', 'cui_str': 'Metabolomics'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C4727084', 'cui_str': 'Lipidome'}]",103.0,0.131476,We observed clear difference in post-intervention serum lipoprotein lipid profiles between the study arms (median classification error 11.7%).,"[{'ForeName': 'Paavo', 'Initials': 'P', 'LastName': 'Raittinen', 'Affiliation': 'Department of Mathematics and Systems Analysis, Aalto University School of Science, Helsinki, Finland. paavo.raittinen@aalto.fi.'}, {'ForeName': 'Kati', 'Initials': 'K', 'LastName': 'Niemistö', 'Affiliation': 'Tampere University, Tampere, Finland.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Pennanen', 'Affiliation': 'School of Pharmacy, University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'Heimo', 'Initials': 'H', 'LastName': 'Syvälä', 'Affiliation': 'Faculty of Medicine and Health Technology, Tampere University and Tays Cancer Center, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Seppo', 'Initials': 'S', 'LastName': 'Auriola', 'Affiliation': 'School of Pharmacy, Faculty of Health Sciences, University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'Jarno', 'Initials': 'J', 'LastName': 'Riikonen', 'Affiliation': 'Tays Cancer Center, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Terho', 'Initials': 'T', 'LastName': 'Lehtimäki', 'Affiliation': 'Department of Clinical Chemistry, Faculty of Medicine and Health Technology, Fimlab Laboratories and Finnish Cardiovascular Research Center-Tampere, Tampere University, Tampere, Finland.'}, {'ForeName': 'Pauliina', 'Initials': 'P', 'LastName': 'Ilmonen', 'Affiliation': 'Department of Mathematics and Systems Analysis, Aalto University School of Science, Helsinki, Finland.'}, {'ForeName': 'Teemu', 'Initials': 'T', 'LastName': 'Murtola', 'Affiliation': 'Faculty of Medicine and Health Technology, Tampere University and Tays Cancer Center, Tampere University Hospital, Tampere, Finland.'}]",Scientific reports,['10.1038/s41598-020-68868-5']
2320,32694705,The closed eye harbours a unique microbiome in dry eye disease.,"Dry eye affects millions of individuals. In experimental models, dry eye disease is associated with T helper cell 17-mediated inflammation of the ocular surface that may cause persistent damage to the corneal epithelium. However, the initiating and perpetuating factors associated with chronic inflammation of the ocular surface remain unclear. The ocular microbiota alters ocular surface inflammation and may influence dry eye disease development and progression. Here, we collected serial samples of tears on awakening from sleep, closed eye tears, during a randomized clinical trial of a non-pharmaceutical dry eye therapy and used 16S rRNA metabarcoding to characterize the microbiome. We show the closed dry eye microbiome is distinct from the healthy closed eye microbiome, and that the microbiome remains distinct despite daily saline eye wash upon awakening. The ocular microbiome was described only recently, and this report implicates a distinct microbiome in ocular disease development. Our findings suggest an interplay between microbial commensals and inflammation on the ocular surface. This information may inform future studies of the pathophysiological mechanisms of dry eye disease.",2020,"In experimental models, dry eye disease is associated with T helper cell 17-mediated inflammation of the ocular surface that may cause persistent damage to the corneal epithelium.",[],[],[],[],[],[],,0.0277235,"In experimental models, dry eye disease is associated with T helper cell 17-mediated inflammation of the ocular surface that may cause persistent damage to the corneal epithelium.","[{'ForeName': 'Kent A', 'Initials': 'KA', 'LastName': 'Willis', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, College of Medicine, The University of Tennessee Health Science Center, Memphis, TN, USA.'}, {'ForeName': 'Cameron K', 'Initials': 'CK', 'LastName': 'Postnikoff', 'Affiliation': 'School of Optometry, University of Alabama At Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Amelia', 'Initials': 'A', 'LastName': 'Freeman', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, College of Medicine, University of Alabama At Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Rezonzew', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, College of Medicine, University of Alabama At Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Nichols', 'Affiliation': 'School of Optometry, University of Alabama At Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Gaggar', 'Affiliation': 'Program in Protease and Matrix Biology, Department of Pediatrics, College of Medicine, Women and Infants Center, University of Alabama At Birmingham, 176F Suite 9380, 619 South 19th Street, Birmingham, AL, 35249-7335, USA.'}, {'ForeName': 'Charitharth V', 'Initials': 'CV', 'LastName': 'Lal', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, College of Medicine, University of Alabama At Birmingham, Birmingham, AL, USA. clal@peds.uab.edu.'}]",Scientific reports,['10.1038/s41598-020-68952-w']
2321,32694245,Psychopathological Networks in Cognitive-Behavioral Treatments for Binge-Eating Disorder.,"INTRODUCTION


Network approaches to psychopathology posit that mental disorders emerge from interrelated symptoms, and thus connectivity among symptoms are assumed to negatively predict the treatment response and decrease with efficacious treatment.
OBJECTIVE


This study uniquely sought to elucidate the network structure, its change, and its predictive value in cognitive-behavioral therapy (CBT) for binge-eating disorder (BED).
METHODS


In a multicenter randomized trial of face-to-face and Internet-based guided self-help CBT, 178 individuals with full syndrome and subsyndromal BED, eating disorder and general psychopathology, and body mass index (BMI) were subjected to Gaussian Graphical Network and Exploratory Graph Analyses before and after treatment and at 6-month follow-up.
RESULTS


At pretreatment, 3 network communities of: eating disorder psychopathology; general psychopathology; and restraint and BMI were identified, with the latter community included in the first thereafter. Eating disorder-related impairment and self-esteem were the most central symptoms, while BMI and binge eating had the lowest centrality. Network connectivity significantly increased from pre- to posttreatment, with the greatest increases in strength centrality found in binge eating and shape concern, but it did not predict remission from binge eating.
CONCLUSIONS


With decreasing symptom severity, CBT resulted in a greater integration and connectivity of the psychopathology network in BED, suggesting an increased patient understanding of relations between binge eating and other symptoms. Network connectivity was not a negative prognostic indicator of treatment outcome. These results indicate a need for further research on the predictive value of network variables in the explanation of therapeutic change for patients with BED.",2020,"Network connectivity significantly increased from pre- to posttreatment, with the greatest increases in strength centrality found in binge eating and shape concern, but it did not predict remission from binge eating.
","['patients with BED', '178 individuals with full syndrome and subsyndromal BED, eating disorder and general psychopathology, and body mass index (BMI', 'binge-eating disorder (BED', 'Binge-Eating Disorder']","['cognitive-behavioral therapy (CBT', 'face-to-face and Internet-based guided self-help CBT']","['strength centrality', 'symptom severity', 'Eating disorder-related impairment and self-esteem', 'Network connectivity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0596170', 'cui_str': 'Binge eating disorder'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0013473', 'cui_str': 'Eating disorder'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C2733435', 'cui_str': 'Guided self-help cognitive behavioral therapy'}]","[{'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0013473', 'cui_str': 'Eating disorder'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}]",178.0,0.0301089,"Network connectivity significantly increased from pre- to posttreatment, with the greatest increases in strength centrality found in binge eating and shape concern, but it did not predict remission from binge eating.
","[{'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Hilbert', 'Affiliation': 'Integrated Research and Treatment Center AdiposityDiseases, Behavioral Medicine Research Unit, Department of Psychosomatic Medicine and Psychotherapy, University of Leipzig Medical Center, Leipzig, Germany, Anja.Hilbert@medizin.uni-leipzig.de.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Herpertz', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, LWL University, Bochum, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Zipfel', 'Affiliation': 'Psychosomatic Medicine and Psychotherapy, Medical University Hospital Tuebingen, Tuebingen, Germany.'}, {'ForeName': 'Brunna', 'Initials': 'B', 'LastName': 'Tuschen-Caffier', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Hans-Christoph', 'Initials': 'HC', 'LastName': 'Friederich', 'Affiliation': 'Department of General Internal Medicine and Psychosomatics, Medical University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Mayr', 'Affiliation': 'Department of Medical Biometry, Informatics and Epidemiology, University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'de Zwaan', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, Hannover Medical School, Hannover, Germany.'}]",Psychotherapy and psychosomatics,['10.1159/000509458']
2322,33095526,Antenatal Dexamethasone for Early Preterm Birth in Low-Resource Countries.,"BACKGROUND


The safety and efficacy of antenatal glucocorticoids in women in low-resource countries who are at risk for preterm birth are uncertain.
METHODS


We conducted a multicountry, randomized trial involving pregnant women between 26 weeks 0 days and 33 weeks 6 days of gestation who were at risk for preterm birth. The participants were assigned to intramuscular dexamethasone or identical placebo. The primary outcomes were neonatal death alone, stillbirth or neonatal death, and possible maternal bacterial infection; neonatal death alone and stillbirth or neonatal death were evaluated with superiority analyses, and possible maternal bacterial infection was evaluated with a noninferiority analysis with the use of a prespecified margin of 1.25 on the relative scale.
RESULTS


A total of 2852 women (and their 3070 fetuses) from 29 secondary- and tertiary-level hospitals across Bangladesh, India, Kenya, Nigeria, and Pakistan underwent randomization. The trial was stopped for benefit at the second interim analysis. Neonatal death occurred in 278 of 1417 infants (19.6%) in the dexamethasone group and in 331 of 1406 infants (23.5%) in the placebo group (relative risk, 0.84; 95% confidence interval [CI], 0.72 to 0.97; P = 0.03). Stillbirth or neonatal death occurred in 393 of 1532 fetuses and infants (25.7%) and in 444 of 1519 fetuses and infants (29.2%), respectively (relative risk, 0.88; 95% CI, 0.78 to 0.99; P = 0.04); the incidence of possible maternal bacterial infection was 4.8% and 6.3%, respectively (relative risk, 0.76; 95% CI, 0.56 to 1.03). There was no significant between-group difference in the incidence of adverse events.
CONCLUSIONS


Among women in low-resource countries who were at risk for early preterm birth, the use of dexamethasone resulted in significantly lower risks of neonatal death alone and stillbirth or neonatal death than the use of placebo, without an increase in the incidence of possible maternal bacterial infection. (Funded by the Bill and Melinda Gates Foundation and the World Health Organization; Australian and New Zealand Clinical Trials Registry number, ACTRN12617000476336; Clinical Trials Registry-India number, CTRI/2017/04/008326.).",2020,"Neonatal death occurred in 278 of 1417 infants (19.6%) in the dexamethasone group and in 331 of 1406 infants (23.5%) in the placebo group (relative risk, 0.84; 95% confidence interval [CI], 0.72 to 0.97; P = 0.03).","['pregnant women between 26 weeks 0 days and 33 weeks 6 days of gestation who were at risk for preterm birth', 'women in low-resource countries who were at risk for early preterm birth', 'women in low-resource countries who are at risk for preterm birth', 'Early Preterm Birth in Low-Resource Countries', '2852 women (and their 3070 fetuses) from 29 secondary- and tertiary-level hospitals across Bangladesh, India, Kenya, Nigeria, and Pakistan underwent randomization']","['Antenatal Dexamethasone', 'dexamethasone or identical placebo', 'dexamethasone', 'placebo', 'antenatal glucocorticoids']","['neonatal death alone, stillbirth or neonatal death, and possible maternal bacterial infection; neonatal death alone and stillbirth or neonatal death were evaluated with superiority analyses, and possible maternal bacterial infection', 'Neonatal death', 'risks of neonatal death alone and stillbirth or neonatal death', 'incidence of possible maternal bacterial infection', 'Stillbirth or neonatal death', 'incidence of adverse events']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C0028075', 'cui_str': 'Nigeria'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}]","[{'cui': 'C0410916', 'cui_str': 'Newborn death'}, {'cui': 'C0595939', 'cui_str': 'Stillbirth'}, {'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0004623', 'cui_str': 'Bacterial infectious disease'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",2852.0,0.544249,"Neonatal death occurred in 278 of 1417 infants (19.6%) in the dexamethasone group and in 331 of 1406 infants (23.5%) in the placebo group (relative risk, 0.84; 95% confidence interval [CI], 0.72 to 0.97; P = 0.03).","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Olufemi T', 'Initials': 'OT', 'LastName': 'Oladapo', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Joshua P', 'Initials': 'JP', 'LastName': 'Vogel', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Gilda', 'Initials': 'G', 'LastName': 'Piaggio', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'My-Huong', 'Initials': 'MH', 'LastName': 'Nguyen', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Althabe', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'A Metin', 'Initials': 'AM', 'LastName': 'Gülmezoglu', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Rajiv', 'Initials': 'R', 'LastName': 'Bahl', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Suman P N', 'Initials': 'SPN', 'LastName': 'Rao', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Ayesha', 'Initials': 'A', 'LastName': 'De Costa', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Shuchita', 'Initials': 'S', 'LastName': 'Gupta', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Abdullah H', 'Initials': 'AH', 'LastName': 'Baqui', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Rasheda', 'Initials': 'R', 'LastName': 'Khanam', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Mohammod', 'Initials': 'M', 'LastName': 'Shahidullah', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Saleha B', 'Initials': 'SB', 'LastName': 'Chowdhury', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Salahuddin', 'Initials': 'S', 'LastName': 'Ahmed', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Nazma', 'Initials': 'N', 'LastName': 'Begum', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Arunangshu', 'Initials': 'A', 'LastName': 'D Roy', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Shahed', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Iffat A', 'Initials': 'IA', 'LastName': 'Jaben', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Farida', 'Initials': 'F', 'LastName': 'Yasmin', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'M Mozibur', 'Initials': 'MM', 'LastName': 'Rahman', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Anjuman', 'Initials': 'A', 'LastName': 'Ara', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Soofia', 'Initials': 'S', 'LastName': 'Khatoon', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Gulshan', 'Initials': 'G', 'LastName': 'Ara', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Shaheen', 'Initials': 'S', 'LastName': 'Akter', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Nasreen', 'Initials': 'N', 'LastName': 'Akhter', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Probhat R', 'Initials': 'PR', 'LastName': 'Dey', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'M Abdus', 'Initials': 'MA', 'LastName': 'Sabur', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Mohammad T', 'Initials': 'MT', 'LastName': 'Azad', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Shahana F', 'Initials': 'SF', 'LastName': 'Choudhury', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Matin', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Shivaprasad S', 'Initials': 'SS', 'LastName': 'Goudar', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Sangappa M', 'Initials': 'SM', 'LastName': 'Dhaded', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Mrityunjay C', 'Initials': 'MC', 'LastName': 'Metgud', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Yeshita V', 'Initials': 'YV', 'LastName': 'Pujar', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Manjunath S', 'Initials': 'MS', 'LastName': 'Somannavar', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Sunil S', 'Initials': 'SS', 'LastName': 'Vernekar', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Veena R', 'Initials': 'VR', 'LastName': 'Herekar', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Shailaja R', 'Initials': 'SR', 'LastName': 'Bidri', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Sangamesh S', 'Initials': 'SS', 'LastName': 'Mathapati', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Preeti G', 'Initials': 'PG', 'LastName': 'Patil', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Mallanagouda M', 'Initials': 'MM', 'LastName': 'Patil', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Muttappa R', 'Initials': 'MR', 'LastName': 'Gudadinni', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Hidaytullah R', 'Initials': 'HR', 'LastName': 'Bijapure', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Ashalata A', 'Initials': 'AA', 'LastName': 'Mallapur', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Geetanjali M', 'Initials': 'GM', 'LastName': 'Katageri', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Sumangala B', 'Initials': 'SB', 'LastName': 'Chikkamath', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Bhuvaneshwari C', 'Initials': 'BC', 'LastName': 'Yelamali', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Ramesh R', 'Initials': 'RR', 'LastName': 'Pol', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Sujata S', 'Initials': 'SS', 'LastName': 'Misra', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Leena', 'Initials': 'L', 'LastName': 'Das', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Saumya', 'Initials': 'S', 'LastName': 'Nanda', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Rashmita B', 'Initials': 'RB', 'LastName': 'Nayak', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Bipsa', 'Initials': 'B', 'LastName': 'Singh', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Zahida', 'Initials': 'Z', 'LastName': 'Qureshi', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Fredrick', 'Initials': 'F', 'LastName': 'Were', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Alfred', 'Initials': 'A', 'LastName': 'Osoti', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Gwako', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Laving', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Kinuthia', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Hafsa', 'Initials': 'H', 'LastName': 'Mohamed', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Nawal', 'Initials': 'N', 'LastName': 'Aliyan', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Adelaide', 'Initials': 'A', 'LastName': 'Barassa', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Kibaru', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Mbuga', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Thuranira', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Njoroge J', 'Initials': 'NJ', 'LastName': 'Githua', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Bernadine', 'Initials': 'B', 'LastName': 'Lusweti', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Adejumoke I', 'Initials': 'AI', 'LastName': 'Ayede', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Adegoke G', 'Initials': 'AG', 'LastName': 'Falade', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Olubukola A', 'Initials': 'OA', 'LastName': 'Adesina', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Atinuke M', 'Initials': 'AM', 'LastName': 'Agunloye', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Oluwatosin O', 'Initials': 'OO', 'LastName': 'Iyiola', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Wilfred', 'Initials': 'W', 'LastName': 'Sanni', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Ifeyinwa K', 'Initials': 'IK', 'LastName': 'Ejinkeonye', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Hadiza A', 'Initials': 'HA', 'LastName': 'Idris', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Chinyere V', 'Initials': 'CV', 'LastName': 'Okoli', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Theresa A', 'Initials': 'TA', 'LastName': 'Irinyenikan', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Omolayo A', 'Initials': 'OA', 'LastName': 'Olubosede', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Olaseinde', 'Initials': 'O', 'LastName': 'Bello', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Olufemi M', 'Initials': 'OM', 'LastName': 'Omololu', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Olanike A', 'Initials': 'OA', 'LastName': 'Olutekunbi', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Adesina L', 'Initials': 'AL', 'LastName': 'Akintan', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Olorunfemi O', 'Initials': 'OO', 'LastName': 'Owa', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Rosena O', 'Initials': 'RO', 'LastName': 'Oluwafemi', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Ireti P', 'Initials': 'IP', 'LastName': 'Eniowo', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Adetokunbo O', 'Initials': 'AO', 'LastName': 'Fabamwo', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Disu', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Joy O', 'Initials': 'JO', 'LastName': 'Agbara', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Ebunoluwa A', 'Initials': 'EA', 'LastName': 'Adejuyigbe', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Oluwafemi', 'Initials': 'O', 'LastName': 'Kuti', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Henry C', 'Initials': 'HC', 'LastName': 'Anyabolu', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Ibraheem O', 'Initials': 'IO', 'LastName': 'Awowole', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Akintunde O', 'Initials': 'AO', 'LastName': 'Fehintola', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Bankole P', 'Initials': 'BP', 'LastName': 'Kuti', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Anthony D', 'Initials': 'AD', 'LastName': 'Isah', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Eyinade K', 'Initials': 'EK', 'LastName': 'Olateju', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Olusanya', 'Initials': 'O', 'LastName': 'Abiodun', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Olabisi F', 'Initials': 'OF', 'LastName': 'Dedeke', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Francis B', 'Initials': 'FB', 'LastName': 'Akinkunmi', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Lawal', 'Initials': 'L', 'LastName': 'Oyeneyin', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Omotayo', 'Initials': 'O', 'LastName': 'Adesiyun', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Hadijat O', 'Initials': 'HO', 'LastName': 'Raji', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Adedapo B A', 'Initials': 'ABA', 'LastName': 'Ande', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Ikechukwu', 'Initials': 'I', 'LastName': 'Okonkwo', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Shabina', 'Initials': 'S', 'LastName': 'Ariff', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Sajid B', 'Initials': 'SB', 'LastName': 'Soofi', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Lumaan', 'Initials': 'L', 'LastName': 'Sheikh', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Saima', 'Initials': 'S', 'LastName': 'Zulfiqar', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Sadia', 'Initials': 'S', 'LastName': 'Omer', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Raheel', 'Initials': 'R', 'LastName': 'Sikandar', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Salma', 'Initials': 'S', 'LastName': 'Sheikh', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Giordano', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Gamerro', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Carroli', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Carvalho', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Neilson', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Molyneux', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Khalid', 'Initials': 'K', 'LastName': 'Yunis', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Kidza', 'Initials': 'K', 'LastName': 'Mugerwa', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Harish K', 'Initials': 'HK', 'LastName': 'Chellani', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}]",The New England journal of medicine,['10.1056/NEJMoa2022398']
2323,33090908,Two-Weeks of Remote Ischemic Conditioning Improves Brachial Artery Flow Mediated Dilation in Chronic Stroke Survivors.,"BACKGROUND


Many stroke survivors have reduced cardiorespiratory fitness as a result of their stroke. Ischemic conditioning (IC) is a non-invasive, cost effective, easy to administer intervention that can be performed at home and has been shown to both improve motor function in stroke survivors and vascular endothelial function in healthy individuals. In this study we examined the effects of two weeks of remote IC (RIC) on brachial artery flow mediated dilation (FMD) in chronic stroke survivors. We hypothesized that FMD would be improved following RIC compared to a RIC Sham control group.
METHODS


This was a prospective, randomized, double-blinded, controlled study. Twenty-four chronic stroke survivors (>6 months post-stroke) were enrolled and randomized to receive either RIC or RIC Sham on their affected thigh every other day for two weeks. For the RIC group, a blood pressure cuff was inflated to 225 mmHg for 5 minutes, followed by 5 minutes of recovery, and repeated a total of 5 times per session. For the RIC Sham group, the inflation pressure was 10 mmHg. Brachial artery FMD was assessed on the non-affected arm at study enrollment and following the two-week intervention period.
RESULTS


Nine men and 14 women completed all study procedures. Brachial artery FMD increased from 5.4±4.8 to 7.8±4.4 % (p=0.030, n=12) in the RIC group while no significant change was observed in the RIC Sham group (3.5±3.9 % pre vs. 2.4±3.1 % post; p=0.281, n=11).
CONCLUSION


Two weeks of RIC increases brachial artery FMD in chronic stroke survivors.",2020,"Brachial artery FMD increased from 5.4±4.8 to 7.8±4.4 % (p=0.030, n=12) in the RIC group while no significant change was observed in the RIC Sham group (3.5±3.9 % pre vs. 2.4±3.1 % post; p=0.281, n=11).
","['healthy individuals', 'Chronic Stroke Survivors', 'chronic stroke survivors', 'Nine men and 14 women completed all study procedures', 'Twenty-four chronic stroke survivors (>6 months post-stroke']","['remote IC (RIC', 'Remote Ischemic Conditioning Improves Brachial Artery Flow Mediated Dilation', 'RIC', 'Ischemic conditioning (IC', 'RIC or RIC']","['blood pressure cuff', 'Brachial artery FMD', 'brachial artery FMD', 'inflation pressure', 'brachial artery flow mediated dilation (FMD']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0006087', 'cui_str': 'Structure of brachial artery'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}]","[{'cui': 'C0180208', 'cui_str': 'Blood pressure cuff'}, {'cui': 'C0006087', 'cui_str': 'Structure of brachial artery'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0021398', 'cui_str': 'Economic Inflation'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}]",24.0,0.117727,"Brachial artery FMD increased from 5.4±4.8 to 7.8±4.4 % (p=0.030, n=12) in the RIC group while no significant change was observed in the RIC Sham group (3.5±3.9 % pre vs. 2.4±3.1 % post; p=0.281, n=11).
","[{'ForeName': 'Allison S', 'Initials': 'AS', 'LastName': 'Hyngstrom', 'Affiliation': 'Department of Physical Therapy, Marquette University, United States.'}, {'ForeName': 'Jennifer N', 'Initials': 'JN', 'LastName': 'Nguyen', 'Affiliation': 'Department of Biomedical Engineering, Marquette University, United States.'}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Wright', 'Affiliation': 'Department of Physical Medicine, Medical College of Wisconsin, United States.'}, {'ForeName': 'Sergey S', 'Initials': 'SS', 'LastName': 'Tarima', 'Affiliation': 'Institute of Health and Equity, Division of Biostatistics, Medical College of Wisconsin, United States.'}, {'ForeName': 'Brian D', 'Initials': 'BD', 'LastName': 'Schmit', 'Affiliation': 'Department of Biomedical Engineering, Marquette University, United States.'}, {'ForeName': 'David D', 'Initials': 'DD', 'LastName': 'Gutterman', 'Affiliation': 'Cardiovascular Center, Medical College of Wisconsin, United States.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Durand', 'Affiliation': 'Physical Medicine and Rehabilitation, Medical College of Wisconsin, United States.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00398.2020']
2324,32703124,Relative efficiencies of alternative preference-based designs for randomised trials.,"Recent work has shown that outcomes in clinical trials can be affected by which treatment the trial participants would select if they were allowed to do so, and if they do or do not actually receive that treatment. These influences are known as selection and preference effects, respectively. Unfortunately, they cannot be evaluated in conventional, parallel group trials because patient preferences remain unknown. However, several alternative designs have been proposed, to measure and take account of patient preferences. In this paper, we discuss three preference-based designs (the two-stage, fully randomised, and partially randomised designs). In conventional trials, only the treatment effect is estimable, while the preference-based designs have the potential to estimate some or all of the selection and preference effects. The relative efficiency of these designs is affected by several factors, including the proportion of participants who are undecided about treatments, or who are unable or unwilling to state a preference; the relative preference rate between the treatments being compared, among patients who do have a preference; and the ratio of patients randomised to each treatment. We also discuss the advantages and disadvantages of these designs under different scenarios.",2020,"The relative efficiency of these designs is affected by several factors, including the proportion of participants who are undecided about treatments, or who are unable or unwilling to state a preference; the relative preference rate between the treatments being compared, among patients who do have a preference; and the ratio of patients randomised to each treatment.",[],[],[],[],[],[],,0.123362,"The relative efficiency of these designs is affected by several factors, including the proportion of participants who are undecided about treatments, or who are unable or unwilling to state a preference; the relative preference rate between the treatments being compared, among patients who do have a preference; and the ratio of patients randomised to each treatment.","[{'ForeName': 'S D', 'Initials': 'SD', 'LastName': 'Walter', 'Affiliation': 'Department of Health Research Methodology, Evidence, and Impact, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bian', 'Affiliation': 'Department of Mathematics & Statistics, McMaster University, Hamilton, ON, Canada.'}]",Statistical methods in medical research,['10.1177/0962280220941874']
2325,32715513,Acceptance and Commitment Therapy for perinatal mood and anxiety disorders: A feasibility and proof of concept study.,"OBJECTIVES


The aim of the current study was to assess the feasibility, safety, and effectiveness of a newly developed Acceptance and Commitment Therapy (ACT) intervention developed specifically to address the unique context of pregnancy and parenthood. The intervention was delivered to women accessing a specialist Perinatal Community Mental Health Service (PCMHS).
DESIGN


An open-label pilot study was conducted of an 8-week, group-delivered ACT intervention targeting women with moderate-to-severe mood and/or anxiety disorders during pregnancy and/or postpartum.
METHODS


Outcomes included session attendance rates, dropout rates, crisis/inpatient service use, and standardized symptom scales. Participant's responses to open-ended questions contained in an end of therapy questionnaire were analysed using thematic analysis.
RESULTS


Seventy-four women were referred to the intervention with 65 (88%) completing treatment. The median number of sessions attended was 7. No women required input from crisis/inpatient services. All reported finding the intervention helpful. The implementation of ACT in daily life, therapist support, and group processes were cited as helpful aspects of the intervention. At post-treatment, there was a significant reduction in global distress (d = 0.99) and depressive symptoms (d = 1.05), and an increase in psychological flexibility (d = 0.93). On the secondary outcome of global distress, 38% of women were classified as recovered, 31% had reliably improved, 27% remained the same, and 4% had reliably deteriorated.
CONCLUSIONS


The delivery of ACT in a routine practice setting is feasible, safe, and effective. A randomized control trial (RCT) is needed to establish the efficacy and cost-effectiveness of this group-delivered ACT intervention.
PRACTITIONER POINTS


Group-delivered Acceptance and Commitment Therapy (ACT) is acceptable for women with moderate-to-severe perinatal mood and/or anxiety disorders and can be feasibly delivered in a routine practice setting. The trans-diagnostic nature of ACT enables the concurrent treatment of depressive and anxiety symptoms within the same intervention which is particularly helpful in the perinatal context given the comorbidity of mood and anxiety disorders. With training and supervision, mental health practitioners without extensive education in the delivery of psychological therapies can facilitate the ACT group programme. As this was a feasibility study, there was no control group, adherence to the manual was not assessed, and the absence of a follow-up period limits our knowledge of the longer-term benefits of the ACT group programme.",2020,"At post-treatment, there was a significant reduction in global distress (d = 0.99) and depressive symptoms (d = 1.05), and an increase in psychological flexibility","['Seventy-four women were referred to the intervention with 65 (88%) completing treatment', 'women with moderate-to-severe perinatal mood and/or anxiety disorders', 'perinatal mood and anxiety disorders', 'targeting women with moderate-to-severe mood and/or anxiety disorders during pregnancy and/or postpartum']","['newly developed Acceptance and Commitment Therapy (ACT) intervention', 'Acceptance and Commitment Therapy (ACT', 'Acceptance and Commitment Therapy', 'women accessing a specialist Perinatal Community Mental Health Service (PCMHS', 'ACT intervention']","['feasibility, safety, and effectiveness', 'efficacy and cost-effectiveness', 'session attendance rates, dropout rates, crisis/inpatient service use, and standardized symptom scales', 'global distress', 'psychological flexibility', 'depressive symptoms']","[{'cui': 'C4517867', 'cui_str': '74'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0178795', 'cui_str': 'Perinatal period'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}]","[{'cui': 'C3658321', 'cui_str': 'Acceptance and commitment therapy'}, {'cui': 'C0029917', 'cui_str': 'Outpatient Commitment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0178795', 'cui_str': 'Perinatal period'}, {'cui': 'C0009475', 'cui_str': 'Mental Health Services, Community'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0231224', 'cui_str': 'Crisis'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",74.0,0.0679024,"At post-treatment, there was a significant reduction in global distress (d = 0.99) and depressive symptoms (d = 1.05), and an increase in psychological flexibility","[{'ForeName': 'Cerith S', 'Initials': 'CS', 'LastName': 'Waters', 'Affiliation': 'Cardiff and Vale University Health Board, Perinatal Community Mental Health Service, Wales, UK.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Annear', 'Affiliation': 'Cardiff and Vale University Health Board, Perinatal Community Mental Health Service, Wales, UK.'}, {'ForeName': 'Gillean', 'Initials': 'G', 'LastName': 'Flockhart', 'Affiliation': 'Cardiff and Vale University Health Board, Perinatal Community Mental Health Service, Wales, UK.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Jones', 'Affiliation': 'Division of Psychological Medicine and Clinical Neurosciences, National Centre for Mental Health, Cardiff University, Wales, UK.'}, {'ForeName': 'Jessica R', 'Initials': 'JR', 'LastName': 'Simmonds', 'Affiliation': 'Cardiff and Vale University Health Board, Perinatal Community Mental Health Service, Wales, UK.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Smith', 'Affiliation': 'Cardiff and Vale University Health Board, Perinatal Community Mental Health Service, Wales, UK.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Traylor', 'Affiliation': 'Cardiff and Vale University Health Board, Perinatal Community Mental Health Service, Wales, UK.'}, {'ForeName': 'Jessica F', 'Initials': 'JF', 'LastName': 'Williams', 'Affiliation': 'Cardiff and Vale University Health Board, Perinatal Community Mental Health Service, Wales, UK.'}]",The British journal of clinical psychology,['10.1111/bjc.12261']
2326,32699231,LSD-induced increases in social adaptation to opinions similar to one's own are associated with stimulation of serotonin receptors.,"Adapting one's attitudes and behaviors to group norms is essential for successful social interaction and, thus, participation in society. Yet, despite its importance for societal and individual functioning, the underlying neuropharmacology is poorly understood. We therefore investigated its neurochemical and neural correlates in a pharmacological functional magnetic resonance imaging study. Lysergic acid diethylamide (LSD) has been shown to alter social processing and therefore provides the unique opportunity to investigate the role of the 5-HT 2A  receptor in social influence processing. Twenty-four healthy human volunteers received either (1) placebo + placebo, (2) placebo + LSD (100 µg), or (3) the 5-HT 2A  receptor antagonist ketanserin (40 mg) + LSD (100 µg) at three different occasions in a double-blind, randomized, counterbalanced, cross-over design. LSD increases social adaptation but only if the opinions of others are similar to the individual's own. These increases were associated with increased activity in the medial prefrontal cortex while participants received social feedback. Furthermore, pretreatment with the 5-HT 2A  antagonist ketanserin fully blocked LSD-induced changes during feedback processing, indicating a key role of the 5-HT 2A  system in social feedback processing. Our results highlight the crucial role of the 5-HT-system in social influence and, thus, provide important insight into the neuropharmacological basis of social cognition and behavior.",2020,"Furthermore, pretreatment with the 5-HT 2A  antagonist ketanserin fully blocked LSD-induced changes during feedback processing, indicating a key role of the 5-HT 2A  system in social feedback processing.",['Twenty-four healthy human volunteers'],"['LSD', '5-HT 2A  receptor antagonist ketanserin (40\xa0mg)\u2009+\u2009LSD', 'placebo\u2009+\u2009placebo, (2) placebo\u2009+\u2009LSD', '5-HT 2A  antagonist ketanserin', 'Lysergic acid diethylamide (LSD']",['social adaptation'],"[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0020155', 'cui_str': 'Human Volunteers'}]","[{'cui': 'C0024334', 'cui_str': 'Lysergic acid diethylamide'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C4543207', 'cui_str': 'Receptor antagonist'}, {'cui': 'C0022616', 'cui_str': 'Ketanserin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}]","[{'cui': 'C0037395', 'cui_str': 'Social adjustment'}]",24.0,0.0406971,"Furthermore, pretreatment with the 5-HT 2A  antagonist ketanserin fully blocked LSD-induced changes during feedback processing, indicating a key role of the 5-HT 2A  system in social feedback processing.","[{'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Duerler', 'Affiliation': 'Neuropsychopharmacology and Brain Imaging, Department of Psychiatry, Psychotherapy and Psychosomatics, University Hospital for Psychiatry Zurich, Lenggstrasse 31, 8032, Zürich, Switzerland. patricia.duerler@bli.uzh.ch.'}, {'ForeName': 'Leonhard', 'Initials': 'L', 'LastName': 'Schilbach', 'Affiliation': 'Independent Max Planck Research Group for Social Neuroscience, Max Planck Institute of Psychiatry, Kraepelinstr. 2-10, 80804, Munich, Germany.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Stämpfli', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, University Hospital for Psychiatry Zurich, Lenggstr. 31, 8032, Zurich, Switzerland.'}, {'ForeName': 'Franz X', 'Initials': 'FX', 'LastName': 'Vollenweider', 'Affiliation': 'Neuropsychopharmacology and Brain Imaging, Department of Psychiatry, Psychotherapy and Psychosomatics, University Hospital for Psychiatry Zurich, Lenggstrasse 31, 8032, Zürich, Switzerland.'}, {'ForeName': 'Katrin H', 'Initials': 'KH', 'LastName': 'Preller', 'Affiliation': 'Neuropsychopharmacology and Brain Imaging, Department of Psychiatry, Psychotherapy and Psychosomatics, University Hospital for Psychiatry Zurich, Lenggstrasse 31, 8032, Zürich, Switzerland.'}]",Scientific reports,['10.1038/s41598-020-68899-y']
2327,32699287,"Hydrogen-rich water reduces inflammatory responses and prevents apoptosis of peripheral blood cells in healthy adults: a randomized, double-blind, controlled trial.","The evidence for the beneficial effects of drinking hydrogen-water (HW) is rare. We aimed to investigate the effects of HW consumption on oxidative stress and immune functions in healthy adults using systemic approaches of biochemical, cellular, and molecular nutrition. In a randomized, double-blind, placebo-controlled study, healthy adults (20-59 y) consumed either 1.5 L/d of HW (n = 20) or plain water (PW, n = 18) for 4 weeks. The changes from baseline to the 4th week in serum biological antioxidant potential (BAP), derivatives of reactive oxygen, and 8-Oxo-2'-deoxyguanosine did not differ between groups; however, in those aged ≥ 30 y, BAP increased greater in the HW group than the PW group. Apoptosis of peripheral blood mononuclear cells (PBMCs) was significantly less in the HW group. Flow cytometry analysis of CD4 + , CD8 + , CD20 + , CD14 +  and CD11b +  cells showed that the frequency of CD14 +  cells decreased in the HW group. RNA-sequencing analysis of PBMCs demonstrated that the transcriptomes of the HW group were clearly distinguished from those of the PW group. Most notably, transcriptional networks of inflammatory responses and NF-κB signaling were significantly down-regulated in the HW group. These finding suggest HW increases antioxidant capacity thereby reducing inflammatory responses in healthy adults.",2020,"Most notably, transcriptional networks of inflammatory responses and NF-κB signaling were significantly down-regulated in the HW group.","['healthy adults', 'healthy adults (20-59 y) consumed either 1.5 L/d of HW (n\u2009=\u200920) or']","['drinking hydrogen-water (HW', 'Hydrogen-rich water', 'plain water', 'HW consumption', 'placebo']","['transcriptional networks of inflammatory responses and NF-κB signaling', 'Apoptosis of peripheral blood mononuclear cells (PBMCs', 'oxidative stress and immune functions', 'frequency of CD14 +  cells', 'BAP', ""serum biological antioxidant potential (BAP), derivatives of reactive oxygen, and 8-Oxo-2'-deoxyguanosine"", 'Flow cytometry analysis of CD4 + , CD8 + , CD20 + , CD14 +  and CD11b +  cells']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0475219', 'cui_str': 'L/day'}, {'cui': 'C0020275', 'cui_str': 'Hydrogen'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}]","[{'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0020275', 'cui_str': 'Hydrogen'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0013123', 'cui_str': 'Water intake'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1720950', 'cui_str': 'Gene Networks'}, {'cui': 'C0162638', 'cui_str': 'Apoptosis'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C1817756', 'cui_str': 'Immunologic function'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0947286', 'cui_str': 'Cell positive for CD14 antigen'}, {'cui': 'C4049351', 'cui_str': 'Biological antioxidant potential'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0243072', 'cui_str': 'derivatives'}, {'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0050078', 'cui_str': '8-hydroxy-deoxyguanosine'}, {'cui': 'C0016263', 'cui_str': 'Flow cytometry'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C3888518', 'cui_str': 'CD20 antigen positive'}, {'cui': 'C0108768', 'cui_str': 'Lymphocyte antigen CD14'}, {'cui': 'C1136310', 'cui_str': 'Lymphocyte antigen CD11b'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}]",,0.289546,"Most notably, transcriptional networks of inflammatory responses and NF-κB signaling were significantly down-regulated in the HW group.","[{'ForeName': 'Minju', 'Initials': 'M', 'LastName': 'Sim', 'Affiliation': 'Department of Food and Nutrition, Seoul National University, Seoul, 08826, Republic of Korea.'}, {'ForeName': 'Chong-Su', 'Initials': 'CS', 'LastName': 'Kim', 'Affiliation': 'Department of Food and Nutrition, Seoul National University, Seoul, 08826, Republic of Korea.'}, {'ForeName': 'Woo-Jeong', 'Initials': 'WJ', 'LastName': 'Shon', 'Affiliation': 'Department of Food and Nutrition, Seoul National University, Seoul, 08826, Republic of Korea.'}, {'ForeName': 'Young-Kwan', 'Initials': 'YK', 'LastName': 'Lee', 'Affiliation': 'Department of Biomedical Sciences, Seoul National University College of Medicine, Seoul, 03080, Republic of Korea.'}, {'ForeName': 'Eun Young', 'Initials': 'EY', 'LastName': 'Choi', 'Affiliation': 'Department of Biomedical Sciences, Seoul National University College of Medicine, Seoul, 03080, Republic of Korea.'}, {'ForeName': 'Dong-Mi', 'Initials': 'DM', 'LastName': 'Shin', 'Affiliation': 'Department of Food and Nutrition, Seoul National University, Seoul, 08826, Republic of Korea. shindm@snu.ac.kr.'}]",Scientific reports,['10.1038/s41598-020-68930-2']
2328,32717033,Brain-Responsive Neurostimulation for Loss of Control Eating: Early Feasibility Study.,"BACKGROUND


Loss of control (LOC) is a pervasive feature of binge eating, which contributes significantly to the growing epidemic of obesity; approximately 80 million US adults are obese. Brain-responsive neurostimulation guided by the delta band was previously found to block binge-eating behavior in mice. Following novel preclinical work and a human case study demonstrating an association between the delta band and reward anticipation, the US Food and Drug Administration approved an Investigational Device Exemption for a first-in-human study.
OBJECTIVE


To assess feasibility, safety, and nonfutility of brain-responsive neurostimulation for LOC eating in treatment-refractory obesity.
METHODS


This is a single-site, early feasibility study with a randomized, single-blinded, staggered-onset design. Six subjects will undergo bilateral brain-responsive neurostimulation of the nucleus accumbens for LOC eating using the RNS® System (NeuroPace Inc). Eligible participants must have treatment-refractory obesity with body mass index ≥ 45 kg/m2. Electrophysiological signals of LOC will be characterized using real-time recording capabilities coupled with synchronized video monitoring. Effects on other eating disorder pathology, mood, neuropsychological profile, metabolic syndrome, and nutrition will also be assessed.
EXPECTED OUTCOMES


Safety/feasibility of brain-responsive neurostimulation of the nucleus accumbens will be examined. The primary success criterion is a decrease of ≥1 LOC eating episode/week based on a 28-d average in ≥50% of subjects after 6 mo of responsive neurostimulation.
DISCUSSION


This study is the first to use brain-responsive neurostimulation for obesity; this approach represents a paradigm shift for intractable mental health disorders.",2020,Six subjects will undergo bilateral brain-responsive neurostimulation of the nucleus accumbens for LOC eating using the RNS® System (NeuroPace Inc).,"['Six subjects will undergo bilateral brain-responsive neurostimulation of the nucleus accumbens for LOC eating using the RNS® System (NeuroPace Inc', 'Eligible participants must have treatment-refractory obesity with body mass index\xa0≥\xa045\xa0kg/m2']",['Brain-Responsive Neurostimulation'],"['decrease of\xa0≥1 LOC eating episode/week based on a 28-d average', 'eating disorder pathology, mood, neuropsychological profile, metabolic syndrome, and nutrition']","[{'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0205342', 'cui_str': 'Responsive'}, {'cui': 'C0521307', 'cui_str': 'Neurostimulation procedure'}, {'cui': 'C0007610', 'cui_str': 'Nucleus'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}]","[{'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0205342', 'cui_str': 'Responsive'}, {'cui': 'C0521307', 'cui_str': 'Neurostimulation procedure'}]","[{'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013473', 'cui_str': 'Eating disorder'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}]",6.0,0.0397596,Six subjects will undergo bilateral brain-responsive neurostimulation of the nucleus accumbens for LOC eating using the RNS® System (NeuroPace Inc).,"[{'ForeName': 'Hemmings', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'Department of Neurosurgery, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Adler', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Dan E', 'Initials': 'DE', 'LastName': 'Azagury', 'Affiliation': 'Department of Surgery, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Cara', 'Initials': 'C', 'LastName': 'Bohon', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Debra L', 'Initials': 'DL', 'LastName': 'Safer', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Daniel A N', 'Initials': 'DAN', 'LastName': 'Barbosa', 'Affiliation': 'Department of Neurosurgery, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Mahendra T', 'Initials': 'MT', 'LastName': 'Bhati', 'Affiliation': 'Department of Neurosurgery, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Nolan R', 'Initials': 'NR', 'LastName': 'Williams', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Laura B', 'Initials': 'LB', 'LastName': 'Dunn', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Tass', 'Affiliation': 'Department of Neurosurgery, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Brian D', 'Initials': 'BD', 'LastName': 'Knutson', 'Affiliation': 'Department of Psychology, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Yutsis', 'Affiliation': 'Department of Neurology and Neurological Sciences, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Ayesha', 'Initials': 'A', 'LastName': 'Fraser', 'Affiliation': 'Department of Neurology and Neurological Sciences, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Tricia', 'Initials': 'T', 'LastName': 'Cunningham', 'Affiliation': 'Department of Neurosurgery, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Kara', 'Initials': 'K', 'LastName': 'Richardson', 'Affiliation': 'Department of Neurosurgery, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Tara L', 'Initials': 'TL', 'LastName': 'Skarpaas', 'Affiliation': 'NeuroPace Inc, 455\xa0N Bernardo Avenue, Mountain View, California.'}, {'ForeName': 'Thomas K', 'Initials': 'TK', 'LastName': 'Tcheng', 'Affiliation': 'NeuroPace Inc, 455\xa0N Bernardo Avenue, Mountain View, California.'}, {'ForeName': 'Martha J', 'Initials': 'MJ', 'LastName': 'Morrell', 'Affiliation': 'NeuroPace Inc, 455\xa0N Bernardo Avenue, Mountain View, California.'}, {'ForeName': 'Laura Weiss', 'Initials': 'LW', 'LastName': 'Roberts', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Malenka', 'Affiliation': 'Nancy Pritzker Laboratory, Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Lock', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Casey H', 'Initials': 'CH', 'LastName': 'Halpern', 'Affiliation': 'Department of Neurosurgery, Stanford University School of Medicine, Stanford, California.'}]",Neurosurgery,['10.1093/neuros/nyaa300']
2329,32720911,The Assessment of Supportive Accountability in Adults Seeking Obesity Treatment: Psychometric Validation Study.,"BACKGROUND


Technology-mediated obesity treatments are commonly affected by poor long-term adherence. Supportive Accountability Theory suggests that the provision of social support and oversight toward goals may help to maintain adherence in technology-mediated treatments. However, no tool exists to measure the construct of supportive accountability.
OBJECTIVE


This study aimed to develop and psychometrically validate a supportive accountability measure (SAM) by examining its performance in technology-mediated obesity treatment.
METHODS


Secondary data analyses were conducted in 2 obesity treatment studies to validate the SAM (20 items). Study 1 examined reliability, criterion validity, and construct validity using an exploratory factor analysis in individuals seeking obesity treatment. Study 2 examined the construct validity of SAM in technology-mediated interventions involving different self-monitoring tools and varying amounts of phone-based interventionist support. Participants received traditional self-monitoring tools (standard, in-home self-monitoring scale [SC group]), newer, technology-based self-monitoring tools (TECH group), or these newer technology tools plus additional phone-based support (TECH+PHONE group). Given that the TECH+PHONE group involves more interventionist support, we hypothesized that this group would have greater supportive accountability than the other 2 arms.
RESULTS


In Study 1 (n=353), the SAM showed strong reliability (Cronbach α=.92). A factor analysis revealed a 3-factor solution (representing Support for Healthy Eating Habits, Support for Exercise Habits, and Perceptions of Accountability) that explained 69% of the variance. Convergent validity was established using items from the motivation for weight loss scale, specifically the social regulation subscale (r=0.33; P<.001) and social pressure for weight loss subscale (r=0.23; P<.001). In Study 2 (n=80), the TECH+PHONE group reported significantly higher SAM scores at 6 months compared with the SC and TECH groups (r 2 =0.45; P<.001). Higher SAM scores were associated with higher adherence to weight management behaviors, including higher scores on subscales representing healthy dietary choices, the use of self-monitoring strategies, and positive psychological coping with weight management challenges. The association between total SAM scores and percent weight change was in the expected direction but not statistically significant (r=-0.26; P=.06).
CONCLUSIONS


The SAM has strong reliability and validity across the 2 studies. Future studies may consider using the SAM in technology-mediated weight loss treatment to better understand whether support and accountability are adequately represented and how supportive accountability impacts treatment adherence and outcomes.
TRIAL REGISTRATION


ClinicalTrials.gov NCT01999244; https://clinicaltrials.gov/ct2/show/NCT01999244.",2020,"Higher SAM scores were associated with higher adherence to weight management behaviors, including higher scores on subscales representing healthy dietary choices, the use of self-monitoring strategies, and positive psychological coping with weight management challenges.","['Adults Seeking Obesity Treatment', 'individuals seeking obesity treatment']","['TECH+PHONE', 'traditional self-monitoring tools (standard, in-home self-monitoring scale [SC group]), newer, technology-based self-monitoring tools (TECH group), or these newer technology tools plus additional phone-based support (TECH+PHONE group']","['total SAM scores and percent weight change', 'Higher SAM scores', 'supportive accountability', 'social regulation subscale', 'SAM scores', 'social pressure for weight loss subscale']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4706528', 'cui_str': 'Obesity care'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0078889', 'cui_str': 'Accountability'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]",,0.0390713,"Higher SAM scores were associated with higher adherence to weight management behaviors, including higher scores on subscales representing healthy dietary choices, the use of self-monitoring strategies, and positive psychological coping with weight management challenges.","[{'ForeName': 'Karishma', 'Initials': 'K', 'LastName': 'Chhabria', 'Affiliation': 'The Center for Health Care Data, Department of Management, Policy and Community Health, University of Texas Health Science Center at Houston, Houston, TX, United States.'}, {'ForeName': 'Kathryn M', 'Initials': 'KM', 'LastName': 'Ross', 'Affiliation': 'Department of Clinical and Health Psychology, University of Florida, Gainesville, FL, United States.'}, {'ForeName': 'Shane J', 'Initials': 'SJ', 'LastName': 'Sacco', 'Affiliation': 'Department of Allied Health Sciences, University of Connecticut, Storrs, CT, United States.'}, {'ForeName': 'Tricia M', 'Initials': 'TM', 'LastName': 'Leahey', 'Affiliation': 'Department of Allied Health Sciences, University of Connecticut, Storrs, CT, United States.'}]",Journal of medical Internet research,['10.2196/17967']
2330,32701013,Novel serum peptide model revealed by MALDI-TOF-MS and its diagnostic value in early bladder cancer.,"BACKGROUND


Bladder cancer is the ninth most common cancer worldwide and has high morbidity and mortality. We aimed to search for potential serum peptide biomarkers and establish a diagnostic model for early bladder cancer.
METHODS


A total of 67 bladder cancer patients and 64 healthy volunteers were randomly divided into a training set and testing set 1. There were 30 hematuria patients used as testing set 2. Matrix-assisted laser desorption/ionization time-of-flight mass spectrometry based on weak cation exchange magnetic beads was used to obtain and analyze the serum peptide profiles between bladder cancer patients and healthy volunteers in the training set. Serum peptide diagnostic model through a k-nearest neighbor algorithm, was established and validated, and significantly differentially expressed protein biomarkers were ultimately identified.
RESULTS


We constructed a diagnostic model containing five peptides (m/z 1954.9, m/z 2081.0, m/z 3938.3, m/z 3946.5, and m/z 4268.8). In the training set, the area under the curve (AUC) value of the five-peptide model was 0.923, and the sensitivity and specificity was 93.75% and 96.77%, respectively. In testing set 1, the sensitivity and specificity was 91.43% and 90.91%, respectively, and the specificity of testing set 2 was 73.33%. For early-stage bladder cancer, the sensitivity and specificity was 92.31% and 93.75%, respectively; the sensitivity of early low-grade bladder cancer was 90.00%; and the AUC value was 0.944.
CONCLUSION


The five-peptide diagnostic model established in this study had high sensitivity and specificity, especially in the diagnosis of early bladder cancer, and could differentiate between healthy volunteers and hematuria patients.",2020,"The five-peptide diagnostic model established in this study had high sensitivity and specificity, especially in the diagnosis of early bladder cancer, and could differentiate between healthy volunteers and hematuria patients.","['early bladder cancer', 'bladder cancer patients and healthy volunteers', 'healthy volunteers and hematuria patients', '67 bladder cancer patients and 64 healthy volunteers', '30 hematuria patients']",['Matrix-assisted laser desorption/ionization time-of-flight mass spectrometry'],"['sensitivity and specificity', 'Serum peptide diagnostic model', 'sensitivity of early low-grade bladder cancer']","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0005684', 'cui_str': 'Malignant tumor of urinary bladder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0018965', 'cui_str': 'Blood in urine'}]","[{'cui': 'C1518101', 'cui_str': 'Matrix-assisted laser desorption/ionisation time-of-flight mass spectrometry'}]","[{'cui': 'C0036668', 'cui_str': 'Sensitivity and Specificity'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C1962916', 'cui_str': 'Low grade (lymphoma)'}, {'cui': 'C0005684', 'cui_str': 'Malignant tumor of urinary bladder'}]",67.0,0.0223575,"The five-peptide diagnostic model established in this study had high sensitivity and specificity, especially in the diagnosis of early bladder cancer, and could differentiate between healthy volunteers and hematuria patients.","[{'ForeName': 'Dapeng', 'Initials': 'D', 'LastName': 'Ding', 'Affiliation': 'Department of Clinical Laboratory, the First Affiliated Hospital of Dalian Medical University, Dalian, Liaoning Province, China.'}, {'ForeName': 'Mingying', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'Department of Clinical Laboratory, the First Affiliated Hospital of Dalian Medical University, Dalian, Liaoning Province, China.'}, {'ForeName': 'Xiaoguang', 'Initials': 'X', 'LastName': 'Xiao', 'Affiliation': 'Department of Clinical Laboratory, the First Affiliated Hospital of Dalian Medical University, Dalian, Liaoning Province, China.'}, {'ForeName': 'Penglong', 'Initials': 'P', 'LastName': 'Cao', 'Affiliation': 'Department of Clinical Laboratory, the First Affiliated Hospital of Dalian Medical University, Dalian, Liaoning Province, China.'}, {'ForeName': 'Shijun', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Department of Clinical Laboratory, the First Affiliated Hospital of Dalian Medical University, Dalian, Liaoning Province, China.'}]",The International journal of biological markers,['10.1177/1724600820935473']
2331,32703680,"Effects of parental education on screen time, sleep disturbances, and psychosocial adaptation among Asian preschoolers: A randomized controlled study.","PURPOSE


A recent increase in screen time during early childhood has adversely affected the sleep and psychosocial health of children; however, limited information is available regarding effective interventions to reduce the screen time among them. This study aimed to investigate the effect of a parental educational program on screen use, sleep quality, and psychosocial adaptation among preschoolers.
DESIGN AND METHODS


A clustered randomized controlled study with a parallel-group design was conducted. Preschoolers with a screen time of ≥2 h/day and their parents were recruited. In total, 14 kindergartens containing 129 parent-child dyads were randomly allocated to either the experimental group (receiving parental education, N = 63 dyads) or the control group (daily activities, N = 66 dyads). Data were collected before and after the intervention. A screen time questionnaire, the Children's Sleep Habits Questionnaire, and the Pediatric Symptom checklist-17 were provided to the participants. A linear mixed-model analysis was performed to examine the efficacy of the intervention.
RESULTS


After the intervention, the screen time of children in the experimental group was significantly reduced (effect size: 0.83, p < .001), and they presented improved sleep quality (effect size: 0.57, p = .01) and attention score (effect size: 0.77, p = .02) for psychosocial adaptation.
CONCLUSIONS


Parental education is an effective intervention for reducing screen time and improving sleep quality and attention among preschoolers.
PRACTICE IMPLICATIONS


Healthcare professionals should consider implementing parental educational programs to reduce screen time, and thus improve the sleep quality and psychosocial health of preschoolers.",2020,"After the intervention, the screen time of children in the experimental group was significantly reduced (effect size: 0.83, p < .001), and they presented improved sleep quality (effect size: 0.57, p = .01) and attention score (effect size: 0.77, p = .02) for psychosocial adaptation.
","['preschoolers', 'In total, 14 kindergartens containing 129 parent-child dyads', 'Asian preschoolers', 'Preschoolers with a screen time of ≥2\xa0h/day and their parents were recruited']","['experimental group (receiving parental education, N\xa0=\xa063 dyads) or the control group (daily activities, N\xa0=\xa066 dyads', 'parental education', 'parental educational program']","['screen time, sleep disturbances, and psychosocial adaptation', ""Children's Sleep Habits Questionnaire"", 'screen time of children', 'screen use, sleep quality, and psychosocial adaptation', 'attention score', 'sleep quality']","[{'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C1520439', 'cui_str': '129 Strain Mouse'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C4704787', 'cui_str': 'Screen Time'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C4704787', 'cui_str': 'Screen Time'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C2133558', 'cui_str': 'Sleep Habits'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0308923,"After the intervention, the screen time of children in the experimental group was significantly reduced (effect size: 0.83, p < .001), and they presented improved sleep quality (effect size: 0.57, p = .01) and attention score (effect size: 0.77, p = .02) for psychosocial adaptation.
","[{'ForeName': 'Yen-Miao', 'Initials': 'YM', 'LastName': 'Lin', 'Affiliation': 'School of Nursing, College of Nursing, Taipei Medical University, Taiwan. Electronic address: marianne01011414@gmail.com.'}, {'ForeName': 'Shu-Yu', 'Initials': 'SY', 'LastName': 'Kuo', 'Affiliation': 'School of Nursing, College of Nursing, Taipei Medical University, Taiwan. Electronic address: sykuo@tmu.edu.tw.'}, {'ForeName': 'Yu-Kai', 'Initials': 'YK', 'LastName': 'Chang', 'Affiliation': 'Department of Physical Education and Institute for Research Excellence in Learning Science, National Taiwan Normal University, Republic of China (Taiwan). Electronic address: yukaichangnew@gmail.com.'}, {'ForeName': 'Pi-Chu', 'Initials': 'PC', 'LastName': 'Lin', 'Affiliation': 'Master Program in Long-Term Care, College of Nursing, Taipei Medical University, Taiwan. Electronic address: pclin@tmu.edu.tw.'}, {'ForeName': 'Yen-Kuang', 'Initials': 'YK', 'LastName': 'Lin', 'Affiliation': 'Biostatistics Center, Taipei Medical University, Taiwan. Electronic address: robbinlin@tmu.edu.tw.'}, {'ForeName': 'Pi-Hsia', 'Initials': 'PH', 'LastName': 'Lee', 'Affiliation': 'School of Nursing, College of Nursing, Taipei Medical University, Taiwan. Electronic address: pihsia@tmu.edu.tw.'}, {'ForeName': 'Pu-Hung', 'Initials': 'PH', 'LastName': 'Lin', 'Affiliation': 'Department of Nursing, Taipei Municipal Wan Fang Hospital, Taiwan. Electronic address: 88235@w.tmu.edu.tw.'}, {'ForeName': 'Su-Ru', 'Initials': 'SR', 'LastName': 'Chen', 'Affiliation': 'Post-Baccalaureate Program in Nursing, College of Nursing, Taipei Medical University, Taiwan. Electronic address: suru@tmu.edu.tw.'}]",Journal of pediatric nursing,['10.1016/j.pedn.2020.07.003']
2332,32710485,Friend or foe? Postdivorce hostility among recently divorced individuals.,"High levels of hostility often occur during and postdivorce and may significantly affect the quality of life, parent-child relationships, and social functioning of divorcees. Moreover, hostility may predict aggressive and violent behavior. This study sought to (a) compare average general hostility levels of a large sample of Danish divorcees to the norms of the general adult Danish population, (b) compare general hostility levels between male and female divorcees, and (c) investigate the explanatory value of various sociodemographic and divorce-related factors on postdivorce general hostility and whether these factors differ across gender. Cross-sectional baseline data (N = 1,856) from a larger randomized controlled trial study was used in this study. Normative data from a general sample of Danish adults (N = 2,040) was used for comparisons of hostility levels between our study sample and the Danish background population. This study found that male and female divorcees did not report significantly different hostility levels. However, participants reported significantly higher hostility levels postdivorce than the comparative Danish norm sample. Significant predictors of postdivorce hostility were lower age, lower educational level, infidelity as a reason for divorce, higher degree of postdivorce conflict, worse communication with the former spouse, the former spouse as the initiator of the divorce, and new partner status with neither divorcees having a new partner, or only the former spouse having a new partner. The predictive strength of the factors did not differ across gender. The findings may be especially relevant for interventions targeting problematic outcomes postdivorce (e.g., preventing aggressive behavior).",2020,The predictive strength of the factors did not differ across gender.,"['Normative data from a general sample of Danish adults (N\u2009=\u20092,040']",[],"['hostility levels', 'Postdivorce hostility', 'quality of life, parent-child relationships, and social functioning of divorcees', 'postdivorce hostility', 'hostility levels postdivorce']","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0010969', 'cui_str': 'Danish language'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]",[],"[{'cui': 'C0020039', 'cui_str': 'Hostile behavior'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030542', 'cui_str': 'Parent-Child Relationship'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}]",,0.0567494,The predictive strength of the factors did not differ across gender.,"[{'ForeName': 'Simone G', 'Initials': 'SG', 'LastName': 'Kjeld', 'Affiliation': 'Department of Public Health, University of Copenhagen, København K, Denmark.'}, {'ForeName': 'Jenna M', 'Initials': 'JM', 'LastName': 'Strizzi', 'Affiliation': 'Department of Public Health, University of Copenhagen, København K, Denmark.'}, {'ForeName': 'Camilla S', 'Initials': 'CS', 'LastName': 'Øverup', 'Affiliation': 'Department of Public Health, University of Copenhagen, København K, Denmark.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Cipric', 'Affiliation': 'Department of Public Health, University of Copenhagen, København K, Denmark.'}, {'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Sander', 'Affiliation': 'Department of Public Health, University of Copenhagen, København K, Denmark.'}, {'ForeName': 'Gert M', 'Initials': 'GM', 'LastName': 'Hald', 'Affiliation': 'Department of Public Health, University of Copenhagen, København K, Denmark.'}]",Aggressive behavior,['10.1002/ab.21918']
2333,32706933,Effects of a Community-Based Multicomponent Positive Psychology Intervention on Mental Health of Rural Adults in Ghana.,"BACKGROUND


There is growing evidence that positive psychology interventions (PPIs) enhance positive mental health and lead to a decrease in symptoms of psychopathology. This study examines the effectiveness of a 10-week multicomponent PPI (the Inspired Life Program; ILP) in promoting positive mental health and reducing symptoms of depression and negative affect in a sample of rural poor adults in Ghana.
METHODS


Using a quasi-randomized controlled trial design, participants from four rural poor communities were randomly allocated to intervention (n = 40) or control (n = 42) conditions. The intervention group participated in the 10-week ILP. Both groups completed a battery of mental health measures, including the Mental Health Continuum-Short Form, at pre-intervention, immediately after the intervention, and at 3 months follow-up. Hierarchical linear modeling was applied to evaluate whether the intervention was effective.
RESULTS


There was a greater improvement in positive mental health, with a marked reduction in symptoms of depression in the intervention group compared to the control group, immediately and 3 months after the intervention. There were also larger increases in the proportion of flourishers in the intervention group compared to the control group, immediately and three months after the intervention.
CONCLUSIONS


The observed effects of the ILP intervention program suggest that group-based PPIs can promote positive mental health and buffer against psychopathology among people living in rural poor communities in sub-Saharan Africa.",2020,"Both groups completed a battery of mental health measures, including the Mental Health Continuum-Short Form, at pre-intervention, immediately after the intervention, and at 3 months follow-up.","['rural poor adults in Ghana', 'participants from four rural poor communities', 'people living in rural poor communities in sub-Saharan Africa', 'Mental Health of Rural Adults in Ghana']","['multicomponent PPI (the Inspired Life Program; ILP', 'positive psychology interventions (PPIs', 'Community-Based Multicomponent Positive Psychology Intervention']","['symptoms of depression', 'proportion of flourishers', 'positive mental health']","[{'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0017516', 'cui_str': 'Ghana'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0001738', 'cui_str': 'Sub-Saharan Africa'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]","[{'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1510628', 'cui_str': 'Positive Psychology'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]",4.0,0.0677002,"Both groups completed a battery of mental health measures, including the Mental Health Continuum-Short Form, at pre-intervention, immediately after the intervention, and at 3 months follow-up.","[{'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Appiah', 'Affiliation': 'Africa Unit for Transdisciplinary Health Research, North-West University, Potchefstroom, South Africa.'}, {'ForeName': 'Angelina', 'Initials': 'A', 'LastName': 'Wilson-Fadiji', 'Affiliation': 'Africa Unit for Transdisciplinary Health Research, North-West University, Potchefstroom, South Africa.'}, {'ForeName': 'Lusilda', 'Initials': 'L', 'LastName': 'Schutte', 'Affiliation': 'Africa Unit for Transdisciplinary Health Research, North-West University, Potchefstroom, South Africa.'}, {'ForeName': 'Marié P', 'Initials': 'MP', 'LastName': 'Wissing', 'Affiliation': 'Africa Unit for Transdisciplinary Health Research, North-West University, Potchefstroom, South Africa.'}]",Applied psychology. Health and well-being,['10.1111/aphw.12212']
2334,32713006,Glycemic Response to a Renal-Specific Oral Nutritional Supplement in Patients With Diabetes Undergoing Hemodialysis: A Randomized Crossover Trial.,"BACKGROUND


Diabetes and malnutrition are common in patients with kidney failure. We aimed to evaluate the postprandial glucose response to oral nutritional supplement drinks (ONSs) in patients with diabetes undergoing hemodialysis treatment.
METHODS


A randomized, single-blind crossover study was conducted in patients with diabetes, and requiring chronic hemodialysis. Patients consumed either a renal-specific ONS, macronutrient-matched ONS, or standard ONS on 3 separate study days, during dialysis, following an overnight fast. Blood was collected before and 15, 30, 45, 60, 90, 120, and 180 minutes post ingestion. Mean net incremental area under the curve (iAUC) and peak incremental blood glucose concentration were compared across conditions, using analyses of variance.
RESULTS


Consumption of the renal-specific ONS resulted in the lowest mean net iAUC (87.9 ± 169.0 mmol/L per 3 hours) compared with macronutrient-matched (188.0 ± 127.5 mmol/L per 3 hours) and standard ONS (199.5 ± 169.2 mmol/L per 3 hours) (F 2,30  = 5.115, P = 0.012, partial n 2  = 0.254). Pairwise comparisons demonstrated a mean difference of 100.1 mmol/L per 3 hours (95% CI, -2.8 to 202.9) in mean iAUC between the renal-specific ONS and macronutrient-matched ONS (P = 0.058). Peak blood glucose concentration, corrected for baseline, was significantly lower after the renal-specific ONS (1.40 ± 1.0 mmol/L) compared with both macronutrient-matched (2.02 ± 0.71 mmol/L, P = 0.036) and standard ONS (2.3 ± 1.06 mmol/L, P = 0.017).
CONCLUSION


A renal-specific ONS elicits a lower postprandial glucose response than either macronutrient-matched ONS or standard ONS in patients with diabetes during hemodialysis.",2020,A renal-specific ONS elicits a lower postprandial glucose response than either macronutrient matched ONS or a standard ONS in patients with diabetes and ESKD undergoing haemodialysis.,"['patients with diabetes and ESKD undergoing haemodialysis', 'Patients with Diabetes Undergoing Haemodialysis', 'patients with diabetes and ESKD requiring chronic haemodialysis', 'patients with end-stage kidney disease (ESKD', 'patients with diabetes undergoing haemodialysis treatment']","['oral nutritional supplement drinks (ONS', 'Renal-Specific Oral Nutritional Supplement', 'renal-specific ONS, a macronutrient matched ONS or a standard ONS', 'macronutrient matched ONS or a standard ONS']","['mean net iAUC', 'Mean net incremental area under the curve (iAUC) and peak incremental blood glucose concentration (iBGC', 'Glycaemic Response', 'Peak blood glucose concentration', 'postprandial glucose response']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C1740835', 'cui_str': 'Chronic haemodialysis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C2585282', 'cui_str': 'Blood glucose concentration'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}]",,0.0467334,A renal-specific ONS elicits a lower postprandial glucose response than either macronutrient matched ONS or a standard ONS in patients with diabetes and ESKD undergoing haemodialysis.,"[{'ForeName': 'Vishal Nainesh', 'Initials': 'VN', 'LastName': 'Patel', 'Affiliation': ""Department of Nutritional Sciences, King's College London, London, UK.""}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Dijk', 'Affiliation': ""Department of Nutritional Sciences, King's College London, London, UK.""}, {'ForeName': 'Bridget', 'Initials': 'B', 'LastName': 'Malarkey', 'Affiliation': ""Department of Nutritional Sciences, King's College London, London, UK.""}, {'ForeName': 'Jennifer R', 'Initials': 'JR', 'LastName': 'Brooke', 'Affiliation': ""Department of Nutritional Sciences, King's College London, London, UK.""}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Whelan', 'Affiliation': ""Department of Nutritional Sciences, King's College London, London, UK.""}, {'ForeName': 'Helen L', 'Initials': 'HL', 'LastName': 'MacLaughlin', 'Affiliation': ""Department of Nutritional Sciences, King's College London, London, UK.""}]",JPEN. Journal of parenteral and enteral nutrition,['10.1002/jpen.1970']
2335,32701372,Re: Effect of Multimodal Prehabilitation vs Postoperative Rehabilitation on 30-Day Postoperative Complications for Frail Patients Undergoing Resection of Colorectal Cancer: A Randomized Clinical Trial.,,2020,,['Frail Patients Undergoing Resection of Colorectal Cancer'],['Multimodal Prehabilitation vs Postoperative Rehabilitation'],['30-Day Postoperative Complications'],"[{'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}]","[{'cui': 'C5192101', 'cui_str': 'Prehabilitation'}, {'cui': 'C0877071', 'cui_str': 'Postoperative rehabilitation'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}]",,0.10665,,"[{'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Resnick', 'Affiliation': ''}]",The Journal of urology,['10.1097/JU.0000000000001215.02']
2336,32709890,Impact of an active lifestyle on heart rate variability and oxidative stress markers in offspring of hypertensives.,"Familial history of hypertension is associated with autonomic dysfunction and increase in blood pressure (BP). However, an active lifestyle has been found to improve a number of health outcomes and reduce all-cause mortality. The aim of the present study was to investigate the effects of an active lifestyle on hemodynamics, heart rate variability (HRV) and oxidative stress markers in offspring of hypertensive parents. One hundred twenty-seven subjects were assigned into four groups: sedentary offspring of normotensives (S-ON) or hypertensives (S-OH); and physically active offspring of normotensives (A-ON) or hypertensives (A-OH). Diastolic BP and heart rate were reduced in the physically active groups when compared to S-OH group. A-ON and A-OH groups presented increased values of RR total variance when compared to the sedentary ones (A-ON: 4,912 ± 538 vs. S-ON: 2,354 ± 159; A-OH: 3,112 ± 236 vs. S-OH: 2,232 ± 241 ms 2 ). Cardiac sympato-vagal balance (LF/HF), systemic hydrogen peroxide and superoxide anion were markedly increased in S-OH group when compared to all other studied groups. Additionally, important correlations were observed between LF/HF with diastolic BP (r = 0.30) and hydrogen peroxide (r = 0.41). Thus, our findings seem to confirm an early autonomic dysfunction in offspring of hypertensive parents, which was associated with a systemic increase in reactive oxygen species and blood pressure. However, our most important finding lies in the attenuation of such disorders in offspring of physically active hypertensives, thus emphasizing the importance of a physically active lifestyle in the prevention of early disorders that may be associated with onset of hypertension.",2020,"A-ON and A-OH groups presented increased values of RR total variance when compared to the sedentary ones (A-ON: 4,912 ± 538 vs. S-ON: 2,354 ± 159; A-OH: 3,112 ± 236 vs. S-OH: 2,232 ± ","['offspring of hypertensives', 'One hundred twenty-seven subjects', 'offspring of hypertensive parents']","['active lifestyle', 'sedentary offspring of normotensives (S-ON) or hypertensives (S-OH); and physically active offspring of normotensives (A-ON) or hypertensives (A-OH']","['LF/HF with diastolic BP', 'heart rate variability and oxidative stress markers', 'hydrogen peroxide', 'blood pressure (BP', 'values of RR total variance', 'reactive oxygen species and blood pressure', 'hemodynamics, heart rate variability (HRV) and oxidative stress markers', 'Diastolic BP and heart rate', 'Cardiac sympato-vagal balance (LF/HF), systemic hydrogen peroxide and superoxide anion']","[{'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0030551', 'cui_str': 'Parent'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0556453', 'cui_str': 'Physically active'}]","[{'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0020281', 'cui_str': 'Hydrogen Peroxide'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0162772', 'cui_str': 'Oxygen Species, Reactive'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0038836', 'cui_str': 'Superoxide'}]",127.0,0.0258121,"A-ON and A-OH groups presented increased values of RR total variance when compared to the sedentary ones (A-ON: 4,912 ± 538 vs. S-ON: 2,354 ± 159; A-OH: 3,112 ± 236 vs. S-OH: 2,232 ± ","[{'ForeName': 'F A', 'Initials': 'FA', 'LastName': 'Santa-Rosa', 'Affiliation': 'Laboratory of Translational Physiology, Universidade Nove de Julho (UNINOVE), São Paulo, Brazil.'}, {'ForeName': 'G L', 'Initials': 'GL', 'LastName': 'Shimojo', 'Affiliation': 'Laboratory of Translational Physiology, Universidade Nove de Julho (UNINOVE), São Paulo, Brazil.'}, {'ForeName': 'D S', 'Initials': 'DS', 'LastName': 'Dias', 'Affiliation': 'Laboratory of Translational Physiology, Universidade Nove de Julho (UNINOVE), São Paulo, Brazil.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Viana', 'Affiliation': 'Laboratory of Translational Physiology, Universidade Nove de Julho (UNINOVE), São Paulo, Brazil.'}, {'ForeName': 'F C', 'Initials': 'FC', 'LastName': 'Lanza', 'Affiliation': 'Laboratory of Translational Physiology, Universidade Nove de Julho (UNINOVE), São Paulo, Brazil.'}, {'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'Irigoyen', 'Affiliation': 'Heart Institute (InCor), Medical School, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'De Angelis', 'Affiliation': 'Laboratory of Translational Physiology, Universidade Nove de Julho (UNINOVE), São Paulo, Brazil. prof.kangelis@yahoo.com.br.'}]",Scientific reports,['10.1038/s41598-020-69104-w']
2337,32717713,"Effect of lifetime antiepileptic drug treatment history on efficacy and tolerability of adjunctive brivaracetam in adults with focal seizures: Post-hoc analysis of a randomized, placebo-controlled trial.","OBJECTIVE


To evaluate the efficacy and tolerability of adjunctive brivaracetam (BRV) in adults with focal seizures by the number of lifetime (previous and concomitant) antiepileptic drugs (AEDs).
METHODS


Post-hoc analysis of data from N01358 (NCT01261325), a randomized, double-blind, placebo (PBO)-controlled Phase III trial evaluating BRV 100 and 200 mg/day in patients ≥16 years of age with uncontrolled focal seizures. Efficacy and tolerability outcomes were assessed for the 12-week Treatment Period in subgroups of patients with 1-2, 3-4, 5-6, or ≥7 lifetime AEDs.
RESULTS


764 patients received at least one dose of trial medication (BRV: 503; PBO: 261; Safety Set), of whom 14.3% had 1-2, 20.8% had 3-4, 21.3% had 5-6, and 43.6% had ≥7 lifetime AEDs. In all lifetime AED subgroups, >85% of patients completed the trial. Patients with a higher number of lifetime AEDs had a younger age at epilepsy onset, longer epilepsy duration, and higher baseline seizure frequency. In patients on BRV, 50% responder rates were 49.3%, 44.4%, 47.2% and 27.4% in patients with 1-2 (n = 75), 3-4 (n = 99), 5-6 (n = 108) and ≥7 (n = 219) lifetime AEDs; 75% responder rates were 36.0%, 21.2%, 22.2% and 12.3%. In patients on PBO, 50% responder rates were 35.3%, 25.9%, 20.4% and 15.9% in patients with 1-2 (n = 34), 3-4 (n = 58), 5-6 (n = 54) and ≥7 (n = 113) lifetime AEDs; 75% responder rates were 26.5%, 6.9%, 3.7% and 4.4%. The Kaplan-Meier estimated probability of patients achieving a sustained 50% or 75% response from the first day of treatment was generally higher in patients with a lower number of lifetime AEDs (both in patients on BRV and PBO). In patients on adjunctive BRV, the incidence of drug related treatment-emergent adverse events (TEAEs) was 34.7%, 26.0%, 44.4% and 47.7% in patients with 1-2 (n = 75), 3-4 (n = 100), 5-6 (n = 108) and ≥7 (n = 220) lifetime AEDs; the incidence of discontinuations due to TEAEs was 1.3%, 3.0%, 8.3% and 10.5%.
CONCLUSIONS


This post-hoc analysis suggests a numerically higher response to adjunctive BRV in patients with fewer lifetime AEDs. The lowest response was observed in patients with ≥7 lifetime AEDs, although these patients could also benefit from adjunctive BRV treatment. Patients with fewer lifetime AEDs had lower discontinuation of BRV due to TEAEs.",2020,"Efficacy and tolerability outcomes were assessed for the 12-week Treatment Period in subgroups of patients with 1-2, 3-4, 5-6, or ≥7 lifetime AEDs.
","['adults with focal seizures by the number of lifetime (previous and concomitant) antiepileptic drugs (AEDs', 'adults with focal seizures', 'subgroups of patients with 1-2, 3-4, 5-6, or ≥7 lifetime AEDs', 'patients ≥16 years of age with uncontrolled focal seizures']","['adjunctive brivaracetam (BRV', 'adjunctive brivaracetam', 'placebo']","['Efficacy and tolerability outcomes', 'responder rates', 'incidence of drug related treatment-emergent adverse events (TEAEs', 'efficacy and tolerability']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0751495', 'cui_str': 'Partial seizure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0003299', 'cui_str': 'ANTIEPILEPTICS'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0442749', 'cui_str': '6/5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}]","[{'cui': 'C1699861', 'cui_str': 'Brivaracetam'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",764.0,0.103758,"Efficacy and tolerability outcomes were assessed for the 12-week Treatment Period in subgroups of patients with 1-2, 3-4, 5-6, or ≥7 lifetime AEDs.
","[{'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Klein', 'Affiliation': 'Mid-Atlantic Epilepsy and Sleep Center, 6410 Rockledge Drive, Suite 610, Bethesda, MD 20817, USA. Electronic address: kleinp@epilepsydc.com.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'McLachlan', 'Affiliation': 'Western University, 339 Windermere Road, London, ON N6A 5A5, Canada. Electronic address: rsmcl@uwo.ca.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Foris', 'Affiliation': 'UCB Pharma, 2060 Winston Park Drive, Suite 401, Oakville, ON L6H 5R7, Canada. Electronic address: kforis@sympatico.ca.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Nondonfaz', 'Affiliation': ""UCB Pharma, Chemin du Foriest, 1420 Braine-l'Alleud, Belgium. Electronic address: xavier.nondonfaz@ucb.com.""}, {'ForeName': 'Sami', 'Initials': 'S', 'LastName': 'Elmoufti', 'Affiliation': 'UCB Pharma, 8010 Arco Corporate Drive, Raleigh, NC 27617, USA. Electronic address: sami.elmoufti@ucb.com.'}, {'ForeName': 'Svetlana', 'Initials': 'S', 'LastName': 'Dimova', 'Affiliation': 'UCB Pharma, Allée de la Recherche 60, 1070 Brussels, Belgium. Electronic address: svetlana.dimova@ucb.com.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Brandt', 'Affiliation': 'Bethel Epilepsy Center, Mara Hospital, Maraweg 21, 33617 Bielefeld, Germany. Electronic address: christian.brandt@mara.de.'}]",Epilepsy research,['10.1016/j.eplepsyres.2020.106369']
2338,32718724,Effects of dobutamine and phenylephrine on cerebral perfusion in patients undergoing cerebral bypass surgery: a randomised crossover trial.,"BACKGROUND


Patients undergoing cerebral bypass surgery are prone to cerebral hypoperfusion. Currently, arterial blood pressure is often increased with vasopressors to prevent cerebral ischaemia. However, this might cause vasoconstriction of the graft and cerebral vasculature and decrease perfusion. We hypothesised that cardiac output, rather than arterial blood pressure, is essential for adequate perfusion and aimed to determine whether dobutamine administration resulted in greater graft perfusion than phenylephrine administration.
METHODS


This randomised crossover study included 10 adult patients undergoing cerebral bypass surgery. Intraoperatively, patients randomly and sequentially received dobutamine to increase cardiac index or phenylephrine to increase mean arterial pressure (MAP). An increase of >10% in cardiac index or >10% in MAP was targeted, respectively. Before both interventions, a reference phase was implemented. The primary outcome was the absolute difference in graft flow between the reference and intervention phase. We compared the absolute flow difference between each intervention and constructed a random-effect linear regression model to explore treatment and carry-over effects.
RESULTS


Graft flow increased with a median of 4.1 (inter-quartile range [IQR], 1.7-12.0] ml min -1 ) after dobutamine administration and 3.6 [IQR, 1.3-7.8] ml min -1  after phenylephrine administration (difference -0.6 ml min -1 ; 95% confidence interval [CI], -14.5 to 5.3; P=0.441). There was no treatment effect (0.9 ml min -1 ; 95% CI, 0.0-20.1; P=0.944) and no carry-over effect.
CONCLUSIONS


Both dobutamine and phenylephrine increased graft flow during cerebral bypass surgery, without a preference for one method over the other.
CLINICAL TRIAL REGISTRATION


Netherlands Trial Register, NL7077 (https://www.trialregister.nl/trial/7077).",2020,"There was no treatment effect (0.9 ml min -1 ; 95% CI, 0.0-20.1; P=0.944) and no carry-over effect.
","['Patients undergoing', '10 adult patients undergoing cerebral bypass surgery', 'patients undergoing cerebral bypass surgery']","['cerebral bypass surgery', 'phenylephrine', 'dobutamine', 'dobutamine and phenylephrine']","['mean arterial pressure (MAP', 'graft perfusion', 'arterial blood pressure', 'graft flow', 'cerebral perfusion', 'Graft flow', 'absolute difference in graft flow']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C1536078', 'cui_str': 'Bypass surgery'}]","[{'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C1536078', 'cui_str': 'Bypass surgery'}, {'cui': 'C0031469', 'cui_str': 'Phenylephrine'}, {'cui': 'C0012963', 'cui_str': 'Dobutamine'}]","[{'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C1272641', 'cui_str': 'Systemic arterial pressure'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}]",10.0,0.476268,"There was no treatment effect (0.9 ml min -1 ; 95% CI, 0.0-20.1; P=0.944) and no carry-over effect.
","[{'ForeName': 'Annemarie', 'Initials': 'A', 'LastName': 'Akkermans', 'Affiliation': 'Department of Anaesthesiology, University Medical Centre Utrecht, Utrecht University, Utrecht, the Netherlands. Electronic address: a.akkermans@umcutrecht.nl.'}, {'ForeName': 'Judith A R', 'Initials': 'JAR', 'LastName': 'van Waes', 'Affiliation': 'Department of Anaesthesiology, University Medical Centre Utrecht, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Tristan P C', 'Initials': 'TPC', 'LastName': 'van Doormaal', 'Affiliation': 'Department of Neurology and Neurosurgery, Brain Centre, University Medical Centre Utrecht, Utrecht University, Utrecht, the Netherlands; Department of Neurosurgery, University Hospital Zürich, Zurich, Switzerland.'}, {'ForeName': 'Eric E C', 'Initials': 'EEC', 'LastName': 'de Waal', 'Affiliation': 'Department of Anaesthesiology, University Medical Centre Utrecht, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Gabriël J E', 'Initials': 'GJE', 'LastName': 'Rinkel', 'Affiliation': 'Department of Neurology and Neurosurgery, Brain Centre, University Medical Centre Utrecht, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'van der Zwan', 'Affiliation': 'Department of Neurology and Neurosurgery, Brain Centre, University Medical Centre Utrecht, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Cor J', 'Initials': 'CJ', 'LastName': 'Kalkman', 'Affiliation': 'Department of Anaesthesiology, University Medical Centre Utrecht, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Wilton A', 'Initials': 'WA', 'LastName': 'van Klei', 'Affiliation': 'Department of Anaesthesiology, University Medical Centre Utrecht, Utrecht University, Utrecht, the Netherlands.'}]",British journal of anaesthesia,['10.1016/j.bja.2020.05.040']
2339,32719420,Neuroplastic effects of end-effector robotic gait training for hemiparetic stroke: a randomised controlled trial.,"Detecting neuroplastic changes during locomotor neurorehabilitation is crucial for independent primal motor behaviours. However, long-term locomotor training-related neuroplasticity remains unexplored. We compared the effects of end-effector robot-assisted gait training (E-RAGT) and bodyweight-supported treadmill training (BWST) on cortical activation in individuals with hemiparetic stroke. Twenty-three men and five women aged 53.2 ± 11.2 years were recruited and randomly assigned to participate in E-RAGT (n = 14) or BWST (n = 14) for 30 min/day, 5 days/week, for 4 weeks. Cortical activity, lower limb motor function, and gait speed were evaluated before and after training. Activation of the primary sensorimotor cortex, supplementary motor area, and premotor cortex in the affected hemisphere significantly increased only in the E-RAGT group, although there were no significant between-group differences. Clinical outcomes, including the Fugl-Meyer assessment (FMA), timed up and go test, and 10-m walk test scores, improved after training in both groups, with significantly better FMA scores in the E-RAGT group than in the BWST group. These findings suggest that E-RAGT effectively improves neuroplastic outcomes in hemiparetic stroke, although its superiority over conventional training remains unclear. This may have clinical implications and provides insight for clinicians interested in locomotor neurorehabilitation after hemiparetic stroke.Trial Registration: ClinicalTrials.gov Identifier NCT04054739 (12/08/2019).",2020,"Activation of the primary sensorimotor cortex, supplementary motor area, and premotor cortex in the affected hemisphere significantly increased only in the E-RAGT group, although there were no significant between-group differences.","['Twenty-three men and five women aged 53.2\u2009±\u200911.2\xa0years', 'hemiparetic stroke', 'individuals with hemiparetic stroke']","['BWST', 'end-effector robotic gait training', 'E-RAGT', 'end-effector robot-assisted gait training (E-RAGT) and bodyweight-supported treadmill training (BWST']","['Fugl-Meyer assessment (FMA), timed up and go test, and 10-m walk test scores', 'FMA scores', 'neuroplastic outcomes', 'supplementary motor area, and premotor cortex', 'cortical activation', 'Cortical activity, lower limb motor function, and gait speed']","[{'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517531', 'cui_str': '11.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C4543203', 'cui_str': 'Effector'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C3496174', 'cui_str': 'Supplementary Motor Area'}, {'cui': 'C0228202', 'cui_str': 'Premotor cortex'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}]",,0.117378,"Activation of the primary sensorimotor cortex, supplementary motor area, and premotor cortex in the affected hemisphere significantly increased only in the E-RAGT group, although there were no significant between-group differences.","[{'ForeName': 'Hayeon', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Translational Research Center for Rehabilitation Robots, National Rehabilitation Center, Seoul, Republic of Korea.'}, {'ForeName': 'Gyulee', 'Initials': 'G', 'LastName': 'Park', 'Affiliation': 'Translational Research Center for Rehabilitation Robots, National Rehabilitation Center, Seoul, Republic of Korea.'}, {'ForeName': 'Joon-Ho', 'Initials': 'JH', 'LastName': 'Shin', 'Affiliation': 'Translational Research Center for Rehabilitation Robots, National Rehabilitation Center, Seoul, Republic of Korea. asfreelyas@gmail.com.'}, {'ForeName': 'Joshua H', 'Initials': 'JH', 'LastName': 'You', 'Affiliation': 'Department of Physical Therapy, Dynamic Movement Institute and Technology, College of Health Science, Sports Movement Artificial-Intelligence Robotics Technology (SMART) Institute, ""Yonsei GOODWELLNESS Center"" for Sports, Wellness, and Fitness Across Life Span Disabilities, Yonsei University, 1 Yonseidae-gil, Wonju, Gangwon-do, 26493, Republic of Korea. neurorehab@yonsei.ac.kr.'}]",Scientific reports,['10.1038/s41598-020-69367-3']
2340,32717448,"Analgesic efficacy of ultrasound guided bilateral transversus thoracis muscle plane block in pediatric cardiac surgery: a randomized, double-blind, controlled study.","STUDY OBJECTIVE


Adequate perioperative pain control in children undergoing cardiac surgery is mandatory. Intravenous opioids and neuraxial anesthetic techniques have been used but didn't gained any popularity. The aim of the current study was to evaluate the analgesic efficacy of transversus thoracis plane (TTP) block in pediatric cardiac surgery.
DESIGN


Superiority, randomized, double-blind, controlled study.
SETTING


Intraoperative and postoperative in intensive care unit (ICU), Mansoura university children hospital, Egypt.
PATIENTS


Eighty pediatric patients aged 2-12 years, undergoing cardiac surgery via median sternotomy, were randomly allocated into 2 equal groups, the control group and TTP block group.
INTERVENTIONS


Controlled group received only fentanyl for perioperative analgesia, while TTP block was performed in the intervention group (TTP group).
MEASUREMENTS


The primary outcome measure was the total dose of fentanyl in the first postoperative 24 h after extubation, while the secondary outcome measures were postoperative pain score, intraoperative fentanyl consumption, time to extubation and ICU length of stay.
MAIN RESULTS


During the first postoperative 24 h, total fentanyl consumption was significantly lower (P < 0.05) in the TTP block group (9.892 ± 3.397 μg/kg) than the control group (18.500 ± 3.401 μg/kg) and modified objective pain score was significantly (P < 0.05) lower in TTP block group than the control group all over the time. Total intraoperative fentanyl requirement was significantly (P < 0.05) lower in TTP block group (8.27 ± 1.170 μg/kg) than the control group (13.72 ± 1.186 μg/kg).
CONCLUSION


The use of TTP block decreased perioperative fentanyl consumption and reduced postoperative pain intensity.",2020,"Total intraoperative fentanyl requirement was significantly (P < 0.05) lower in TTP block group (8.27 ± 1.170 μg/kg) than the control group (13.72 ± 1.186 μg/kg).
","['children undergoing cardiac surgery', 'Intraoperative and postoperative in intensive care unit (ICU), Mansoura university children hospital, Egypt', 'Eighty pediatric patients aged 2-12\xa0years, undergoing cardiac surgery via median sternotomy', 'pediatric cardiac surgery']","['TTP block', 'transversus thoracis plane (TTP) block', 'fentanyl for perioperative analgesia, while TTP block was performed in the intervention group (TTP group', 'control group and TTP block group', 'ultrasound guided bilateral transversus thoracis muscle plane block']","['postoperative pain intensity', 'modified objective pain score', 'perioperative fentanyl consumption', 'Analgesic efficacy', 'analgesic efficacy', 'total fentanyl consumption', 'Total intraoperative fentanyl requirement', 'postoperative pain score, intraoperative fentanyl consumption, time to extubation and ICU length of stay', 'total dose of fentanyl in the first postoperative 24\xa0h after extubation']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0013715', 'cui_str': 'Egypt'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1282959', 'cui_str': 'Median sternotomy'}]","[{'cui': 'C1744608', 'cui_str': 'Structure of transverse thoracis muscle'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C1096288', 'cui_str': 'Perioperative analgesia'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",80.0,0.408484,"Total intraoperative fentanyl requirement was significantly (P < 0.05) lower in TTP block group (8.27 ± 1.170 μg/kg) than the control group (13.72 ± 1.186 μg/kg).
","[{'ForeName': 'Ibrahim I', 'Initials': 'II', 'LastName': 'Abdelbaser', 'Affiliation': 'Department of Anesthesiology and Surgical Intensive Care, Faculty of Medicine, Mansoura University, 2 El-Gomhouria St, Mansoura 35516, Egypt. Electronic address: ibraheem2005@mans.edu.eg.'}, {'ForeName': 'Nabil A', 'Initials': 'NA', 'LastName': 'Mageed', 'Affiliation': 'Department of Anesthesiology and Surgical Intensive Care, Faculty of Medicine, Mansoura University, 2 El-Gomhouria St, Mansoura 35516, Egypt.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.110002']
2341,32717684,"Switching to fingolimod in PREFERMS: Effect of treatment history and naïvety on clinical, MRI and treatment satisfaction outcomes ✰ .","BACKGROUND


Injectable disease-modifying therapies (iDMTs) are often used as first-line treatments for relapsing multiple sclerosis. Fingolimod is frequently used following treatment with iDMTs. Whether prior iDMT treatment impacts the effectiveness of subsequent fingolimod therapy is unclear. Here, we assessed switching from iDMTs to fingolimod, and the impact of treatment history on fingolimod escalation using data from the 12-month 'Prospective, Randomized, active-controlled, open-label study to Evaluate patient retention on Fingolimod versus approved first-line disease-modifying thErapies in adults with Relapsing-remitting Multiple Sclerosis' (PREFERMS). The study design and results at the end of randomized treatment (EoRT) in PREFERMS have been published.
METHODS


Both treatment-naïve patients and those who had previously received an iDMT were eligible for enrolment in PREFERMS, and one treatment switch was permitted on study. Pre-specified exploratory analyses compared outcomes in those randomized to fingolimod or to an iDMT at end of study (EoS), which included time spent on randomized and on switch treatment. Post hoc exploratory analyses (unadjusted for multiplicity owing to the large number of comparisons) among patients randomized to an iDMT who switched to fingolimod, compared outcomes longitudinally before (EoRT) and after (EoS) switching, and compared outcomes at EoRT and EoS among subgroups stratified by iDMT-treatment history. Outcomes included brain volume, various measures of gadolinium-enhancing [Gd+] lesion counts, annualized relapse rate (ARR), Symbol Digit Modalities Test (SDMT) score, patient-reported treatment satisfaction using the Medication Satisfaction Questionnaire (MSQ) and adverse event (AE) rates.
RESULTS


At EoS, 255 of 439 patients randomized to an iDMT had switched to fingolimod and 27 of 436 patients randomized to fingolimod had switched to an iDMT. By EoS, 44.2% of total treatment exposure in the iDMT group was to fingolimod and the mean time spent on fingolimod in this group was 220 days (approximately 7 months). Outcomes in the fingolimod group at EoS (brain volume, changes in Gd+ lesion counts, ARR, oral SDMT score and MSQ score) were similar to those seen at EoRT, but in the iDMT group these outcomes were more favorable at EoS than at EoRT and were similar to rates seen in the fingolimod group. Among patients who switched from iDMT to fingolimod, there were longitudinal improvements in ARR (EoRT, 0.3 [95% confidence interval (CI), 0.2-0.4]; EoS, 0.2 [0.1-0.3]; odds ratio, 0.5 [0.3-0.9]) and in treatment satisfaction (proportion of patients with MSQ > 5; EoRT, 67.4%; EoS, 90.4%; odds ratio, 5.7 [95% CI, 3.4-9.4]) after fingolimod treatment, and changes in brain volume, Gd+ lesion count, and AEs or AEs causing discontinuation were also more favorable at EoS than at EoRT. In all patient groups stratified by iDMT-treatment history, differences in outcomes narrowed or disappeared after fingolimod treatment.
CONCLUSION


These analyses indicate that patients in PREFERMS had improved outcomes within months of switching to fingolimod from an iDMT and that improvements occurred irrespective of the number of iDMTs previously administered. These data provide a unique opportunity to explore clinical, radiological and safety outcomes associated with a range of clinically relevant treatment pathways.",2020,"In all patient groups stratified by iDMT-treatment history, differences in outcomes narrowed or disappeared after fingolimod treatment.
","['At EoS, 255 of 439 patients randomized to an iDMT had switched to fingolimod and 27 of 436 patients randomized to', 'Both treatment-naïve patients and those who had previously received an iDMT were eligible for enrolment in PREFERMS, and one treatment switch was permitted on study', ""adults with Relapsing-remitting Multiple Sclerosis' (PREFERMS""]","['fingolimod had switched to an iDMT', 'Fingolimod versus approved first-line disease-modifying thErapies']","['EoS (brain volume, changes in Gd+ lesion counts, ARR, oral SDMT score and MSQ score', 'mean time spent on fingolimod', 'brain volume, various measures of gadolinium-enhancing [Gd+] lesion counts, annualized relapse rate (ARR), Symbol Digit Modalities Test (SDMT) score, patient-reported treatment satisfaction using the Medication Satisfaction Questionnaire (MSQ) and adverse event (AE) rates', 'longitudinal improvements in ARR', 'brain volume, Gd+ lesion count, and AEs or AEs causing discontinuation']","[{'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1699926', 'cui_str': 'fingolimod'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0023636', 'cui_str': 'Licenses'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0751967', 'cui_str': 'Relapsing remitting multiple sclerosis'}]","[{'cui': 'C1699926', 'cui_str': 'fingolimod'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1699926', 'cui_str': 'fingolimod'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0016911', 'cui_str': 'Gadolinium'}, {'cui': 'C0451522', 'cui_str': 'Symbol digit modalities test'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}]",439.0,0.0609136,"In all patient groups stratified by iDMT-treatment history, differences in outcomes narrowed or disappeared after fingolimod treatment.
","[{'ForeName': 'Samuel F', 'Initials': 'SF', 'LastName': 'Hunter', 'Affiliation': 'Advanced Neurosciences Institute, 101 Forrest Crossing Blvd. Suite 103, Franklin, TN 37064, United States. Electronic address: sfhunter@neurosci.us.'}, {'ForeName': 'Florian P', 'Initials': 'FP', 'LastName': 'Thomas', 'Affiliation': 'Hackensack Meridian School of Medicine at Seton Hall University, South Orange, and Hackensack University Medical Center, Hackensack, NJ, United States. Electronic address: florian.thomas@hackensackmeridian.org.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Cascione', 'Affiliation': 'Tampa Neurology Associates, Tampa, FL, United States. Electronic address: me@markcascione.com.'}, {'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Williams', 'Affiliation': 'Oxford PharmaGenesis, Oxford, United Kingdom. Electronic address: ian.williams@pharmagenesis.com.'}, {'ForeName': 'Xiangyi', 'Initials': 'X', 'LastName': 'Meng', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, United States. Electronic address: xiangyi.meng@novartis.com.'}, {'ForeName': 'Lesley', 'Initials': 'L', 'LastName': 'Schofield', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, United States. Electronic address: lesley.schofield@novartis.com.'}, {'ForeName': 'Jamie L', 'Initials': 'JL', 'LastName': 'Weiss', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, United States. Electronic address: jamie.weiss@novartis.com.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Tenenbaum', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, United States. Electronic address: nadia.tenebaum@novartis.com.'}, {'ForeName': 'Bruce A C', 'Initials': 'BAC', 'LastName': 'Cree', 'Affiliation': 'UCSF Weill Institute for Neurosciences, University of California San Francisco, San Francisco, CA, United States. Electronic address: bruce.cree@ucsf.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2020.102346']
2342,32719487,Assessment of cognitive and neural recovery in survivors of pediatric brain tumors in a pilot clinical trial using metformin.,"We asked whether pharmacological stimulation of endogenous neural precursor cells (NPCs) may promote cognitive recovery and brain repair, focusing on the drug metformin, in parallel rodent and human studies of radiation injury. In the rodent cranial radiation model, we found that metformin enhanced the recovery of NPCs in the dentate gyrus, with sex-dependent effects on neurogenesis and cognition. A pilot double-blind, placebo-controlled crossover trial was conducted (ClinicalTrials.gov, NCT02040376) in survivors of pediatric brain tumors who had been treated with cranial radiation. Safety, feasibility, cognitive tests and MRI measures of white matter and the hippocampus were evaluated as endpoints. Twenty-four participants consented and were randomly assigned to complete 12-week cycles of metformin (A) and placebo (B) in either an AB or BA sequence with a 10-week washout period at crossover. Blood draws were conducted to monitor safety. Feasibility was assessed as recruitment rate, medication adherence and procedural adherence. Linear mixed modeling was used to examine cognitive and MRI outcomes as a function of cycle, sequence and treatment. We found no clinically relevant safety concerns and no serious adverse events associated with metformin. Sequence effects were observed for all cognitive outcomes in our linear mixed models. For the subset of participants with complete data in cycle 1, metformin was associated with better performance than placebo on tests of declarative and working memory. We present evidence that a clinical trial examining the effects of metformin on cognition and brain structure is feasible in long-term survivors of pediatric brain tumors and that metformin is safe to use and tolerable in this population. This pilot trial was not intended to test the efficacy of metformin for cognitive recovery and brain growth, but the preliminary results are encouraging and warrant further investigation in a large multicenter phase 3 trial.",2020,"For the subset of participants with complete data in cycle 1, metformin was associated with better performance than placebo on tests of declarative and working memory.","['Twenty-four participants consented', 'survivors of pediatric brain tumors', 'survivors of pediatric brain tumors who had been treated with cranial radiation']","['metformin (A) and placebo (B', 'pharmacological stimulation of endogenous neural precursor cells (NPCs', 'metformin', 'placebo']","['Safety, feasibility, cognitive tests and MRI measures of white matter and the hippocampus', 'declarative and working memory', 'recruitment rate, medication adherence and procedural adherence', 'recovery of NPCs']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0006118', 'cui_str': 'Neoplasm of brain'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0037303', 'cui_str': 'Bone structure of cranium'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0441694', 'cui_str': 'Pharmacological stimulation'}, {'cui': 'C0205227', 'cui_str': 'Endogenous'}, {'cui': 'C0018956', 'cui_str': 'Hematopoietic stem cell'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0018956', 'cui_str': 'Hematopoietic stem cell'}]",24.0,0.0743775,"For the subset of participants with complete data in cycle 1, metformin was associated with better performance than placebo on tests of declarative and working memory.","[{'ForeName': 'Ramy', 'Initials': 'R', 'LastName': 'Ayoub', 'Affiliation': 'Neurosciences and Mental Health Program, Research Institute, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Rebecca M', 'Initials': 'RM', 'LastName': 'Ruddy', 'Affiliation': 'Institute of Medical Science, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Cox', 'Affiliation': 'Neurosciences and Mental Health Program, Research Institute, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Adeoye', 'Initials': 'A', 'LastName': 'Oyefiade', 'Affiliation': 'Neurosciences and Mental Health Program, Research Institute, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Derkach', 'Affiliation': 'Institute of Medical Science, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Laughlin', 'Affiliation': 'Diagnostic Imaging, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Ades-Aron', 'Affiliation': 'Center for Biomedical Imaging, Department of Radiology, New York University Grossman School of Medicine, New York, NY, USA.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Shirzadi', 'Affiliation': 'Department of Medical Biophysics, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Els', 'Initials': 'E', 'LastName': 'Fieremans', 'Affiliation': 'Center for Biomedical Imaging, Department of Radiology, New York University Grossman School of Medicine, New York, NY, USA.'}, {'ForeName': 'Bradley J', 'Initials': 'BJ', 'LastName': 'MacIntosh', 'Affiliation': 'Department of Medical Biophysics, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Cynthia B', 'Initials': 'CB', 'LastName': 'de Medeiros', 'Affiliation': 'Neurosciences and Mental Health Program, Research Institute, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Jovanka', 'Initials': 'J', 'LastName': 'Skocic', 'Affiliation': 'Neurosciences and Mental Health Program, Research Institute, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Bouffet', 'Affiliation': 'Division of Haematology/Oncology, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Freda D', 'Initials': 'FD', 'LastName': 'Miller', 'Affiliation': 'Neurosciences and Mental Health Program, Research Institute, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Cindi M', 'Initials': 'CM', 'LastName': 'Morshead', 'Affiliation': 'Institute of Medical Science, University of Toronto, Toronto, Ontario, Canada. cindi.morshead@utoronto.ca.'}, {'ForeName': 'Donald J', 'Initials': 'DJ', 'LastName': 'Mabbott', 'Affiliation': 'Neurosciences and Mental Health Program, Research Institute, Hospital for Sick Children, Toronto, Ontario, Canada. donald.mabbott@sickkids.ca.'}]",Nature medicine,['10.1038/s41591-020-0985-2']
2343,32725102,N-acetylcysteine as an adjunctive treatment for smoking cessation: a randomized clinical trial.,"OBJECTIVE


This randomized controlled trial examined the efficacy and safety of N-acetylcysteine as an adjunctive treatment for smoking cessation.
METHODS


Heavy smokers were recruited from smoking cessation treatment for this 12- week randomized controlled trial. Eligible tobacco use disorder outpatients (n=34) were randomized to N-acetylcysteine or placebo plus first-line treatment. Abstinence was verified by exhaled carbon monoxide (COexh). The assessment scales included the Fagerström Test for Nicotine Dependence, the Hamilton Depression Rating Scale, the Hamilton Anxiety Rating Scale, the Minnesota Nicotine Withdrawal Scale, and the Medication Adherence Rating Scale. We also assessed anthropometrics, blood pressure, lipid profile, and soluble tumor necrosis factor receptor (sTNF-R) levels 1 and 2.
RESULTS


First-line treatment for smoking cessation plus adjunctive N-acetylcysteine or placebo significantly reduced COexh (p < 0.01). In the N-acetylcysteine group, no significant changes were found in nicotine withdrawal symptoms, depressive and anxiety symptoms, anthropometric measures, blood pressure, or glucose compared to placebo. However, there was a significant reduction in sTNF-R2 levels between baseline and week 12 in the N-acetylcysteine group.
CONCLUSIONS


These findings highlight the need to associate N-acetylcysteine with first-line treatment for smoking cessation, since combined treatment may affect inflammation and metabolism components.
CLINICAL TRIAL REGISTRATION


NCT02420418.",2020,"In the N-acetylcysteine group, no significant changes were found in nicotine withdrawal symptoms, depressive and anxiety symptoms, anthropometric measures, blood pressure, or glucose compared to placebo.","['Eligible tobacco use disorder outpatients (n=34', 'Heavy smokers were recruited from smoking cessation treatment for this 12- week randomized controlled trial']","['N-acetylcysteine or placebo plus first-line treatment', 'N-acetylcysteine', 'placebo']","['nicotine withdrawal symptoms, depressive and anxiety symptoms, anthropometric measures, blood pressure, or glucose', 'exhaled carbon monoxide (COexh', 'COexh', 'Fagerström Test for Nicotine Dependence, the Hamilton Depression Rating Scale, the Hamilton Anxiety Rating Scale, the Minnesota Nicotine Withdrawal Scale, and the Medication Adherence Rating Scale', 'anthropometrics, blood pressure, lipid profile, and soluble tumor necrosis factor receptor (sTNF-R) levels 1 and 2', 'sTNF-R2 levels']","[{'cui': 'C0040336', 'cui_str': 'Tobacco abuse'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C3494625', 'cui_str': 'Heavy tobacco smoker'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1708063', 'cui_str': 'First line treatment'}]","[{'cui': 'C0028047', 'cui_str': 'Nicotine withdrawal'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0028043', 'cui_str': 'Nicotine dependence'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0026183', 'cui_str': 'Minnesota'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0077503', 'cui_str': 'Tumor Necrosis Factor Receptor'}, {'cui': 'C0456947', 'cui_str': 'Level 1'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",34.0,0.0382141,"In the N-acetylcysteine group, no significant changes were found in nicotine withdrawal symptoms, depressive and anxiety symptoms, anthropometric measures, blood pressure, or glucose compared to placebo.","[{'ForeName': 'Regina C B R', 'Initials': 'RCBR', 'LastName': 'Machado', 'Affiliation': 'Centro de Referência de Abordagem e Tratamento do Tabagismo, Hospital Universitário, Universidade Estadual de Londrina (UEL), Londrina, PR, Brazil.'}, {'ForeName': 'Heber O', 'Initials': 'HO', 'LastName': 'Vargas', 'Affiliation': 'Centro de Referência de Abordagem e Tratamento do Tabagismo, Hospital Universitário, Universidade Estadual de Londrina (UEL), Londrina, PR, Brazil.'}, {'ForeName': 'Marcela M', 'Initials': 'MM', 'LastName': 'Baracat', 'Affiliation': 'Programa de Pós-Graduação em Ciências da Saúde, Centro de Ciências da Saúde (CCS), UEL, Londrina, PR, Brazil.'}, {'ForeName': 'Mariana R', 'Initials': 'MR', 'LastName': 'Urbano', 'Affiliation': 'Programa de Pós-Graduação em Ciências da Saúde, Centro de Ciências da Saúde (CCS), UEL, Londrina, PR, Brazil.'}, {'ForeName': 'Waldiceu A', 'Initials': 'WA', 'LastName': 'Verri', 'Affiliation': 'Programa de Pós-Graduação em Ciências da Saúde, Centro de Ciências da Saúde (CCS), UEL, Londrina, PR, Brazil.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Porcu', 'Affiliation': 'Centro de Referência de Abordagem e Tratamento do Tabagismo, Hospital Universitário, Universidade Estadual de Londrina (UEL), Londrina, PR, Brazil.'}, {'ForeName': 'Sandra O V', 'Initials': 'SOV', 'LastName': 'Nunes', 'Affiliation': 'Centro de Referência de Abordagem e Tratamento do Tabagismo, Hospital Universitário, Universidade Estadual de Londrina (UEL), Londrina, PR, Brazil.'}]","Revista brasileira de psiquiatria (Sao Paulo, Brazil : 1999)",['10.1590/1516-4446-2019-0753']
2344,32722253,Implementation of a Urinary Tract Infection Treatment Protocol to Improve Prescribing Practices in the Long-Term Care Facility of a Veteran's Healthcare System.,"Urinary tract infections (UTIs) are a commonly diagnosed problem in long-term care facilities (LTCFs), but antimicrobial treatment is often incorrectly prescribed. Although bacterial resistance to antimicrobials commonly used for UTIs, such as trimethoprim/sulfamethoxazole and fluoroquinolones, has been dramatically increasing, they are still commonly prescribed. The purpose of this project was to determine if implementation of a standard treatment protocol for UTIs, which emphasized correct UTI diagnosis and use of nitrofurantoin and cefpodoxime/ceftriaxone as empiric therapy per the institutional antibiogram, changed clinician prescribing practices. This quasi-experimental model utilized two years of pre-intervention and two years of post-intervention data. Three hundred patient encounters were included. Antibiotics prescribed in the pre-intervention period included: trimethoprim/sulfamethoxazole (32%), ciprofloxacin (14%), amoxicillin (13%), levofloxacin (9%), cefpodoxime (9%), ceftriaxone (8%), amoxicillin/clavulanate (5%), nitrofurantoin (4%), and other (6%). By contrast, antibiotics prescribed in the post-intervention period included: cefpodoxime (46%), nitrofurantoin (30%), ceftriaxone (10%), trimethoprim/sulfamethoxazole (8%), amoxicillin/clavulanate (1%), and other (5%). These differences in prescribed drug between the pre-intervention and post-intervention encounters were statistically significant ( p  < 0.001). Overall, appropriate empiric treatment was prescribed in only 48/217 encounters (22%) during the pre-intervention period, but this increased to 73/83 encounters (88%) in the post-intervention period ( p  < 0.001). The results indicate that the treatment protocol was successful in changing prescribing practices and decreasing the use of inappropriate antimicrobials at the LTCF.",2020,The results indicate that the treatment protocol was successful in changing prescribing practices and decreasing the use of inappropriate antimicrobials at the LTCF.,['Three hundred patient encounters were included'],"['nitrofurantoin', 'ciprofloxacin', 'amoxicillin/clavulanate (5%), nitrofurantoin', 'nitrofurantoin and cefpodoxime/ceftriaxone', 'amoxicillin', 'trimethoprim/sulfamethoxazole', 'levofloxacin', 'amoxicillin/clavulanate', 'ceftriaxone']",['Urinary tract infections (UTIs'],"[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0028156', 'cui_str': 'Nitrofurantoin'}, {'cui': 'C0008809', 'cui_str': 'Ciprofloxacin'}, {'cui': 'C0054066', 'cui_str': 'Amoxicillin and clavulanate'}, {'cui': 'C0055011', 'cui_str': 'cefpodoxime'}, {'cui': 'C0007561', 'cui_str': 'Ceftriaxone'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0041041', 'cui_str': 'Trimethoprim'}, {'cui': 'C0038689', 'cui_str': 'Sulfamethoxazole'}, {'cui': 'C0282386', 'cui_str': 'Levofloxacin'}]","[{'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}]",,0.0308431,The results indicate that the treatment protocol was successful in changing prescribing practices and decreasing the use of inappropriate antimicrobials at the LTCF.,"[{'ForeName': 'Spencer H', 'Initials': 'SH', 'LastName': 'Durham', 'Affiliation': 'Department of Pharmacy Practice, Harrison School of Pharmacy, Auburn University, Auburn, AL 36849-5341, USA.'}, {'ForeName': 'Natalie S', 'Initials': 'NS', 'LastName': 'Hohmann', 'Affiliation': 'Department of Pharmacy Practice, Harrison School of Pharmacy, Auburn University, Auburn, AL 36849-5341, USA.'}, {'ForeName': 'Addison H', 'Initials': 'AH', 'LastName': 'Ragan', 'Affiliation': 'Department of Pharmacy, Central Alabama Veterans Health Care System, Montgomery, AL 36109, USA.'}]","Pharmacy (Basel, Switzerland)",['10.3390/pharmacy8030129']
2345,32700215,Mobile-Enhanced Peer Support for African Americans with Type 2 Diabetes: a Randomized Controlled Trial.,"BACKGROUND


Peer support has been shown to improve diabetes self-management and control, but no standard exists to link peer support interventions to clinical care.
OBJECTIVE


To compare a community-based diabetes self-management education (DSME) plus mobile health (mHealth)-enhanced peer support intervention to community-based diabetes self-management education (DSME) alone for African American adults with poorly controlled type 2 diabetes.
DESIGN


A randomized controlled trial.
PARTICIPANTS


African American adults, age > 19 years, receiving care within a safety-net healthcare system in Jefferson County, Alabama, with a diagnosis of type 2 diabetes and a hemoglobin A1c (A1C) ≥ 7.5%.
INTERVENTIONS


Participants in the intervention group received community-based diabetes self-management education (DSME) plus 6 months of mHealth-enhanced peer support, including 12 weekly phone calls, then 3 monthly calls from community health workers, who used a novel web application to communicate with participants' healthcare teams. In the control group, participants received community-based DSME alone.
MAIN MEASURES


The primary outcome was A1C; secondary outcomes included diabetes distress, depressive symptoms, self-efficacy or confidence in their ability to manage diabetes, and social support. We used mixed models repeated measures analyses to assess for between-arm differences and baseline to follow-up changes.
KEY RESULTS


Of 120 participants randomized, 97 completed the study. Participants in intervention and control groups experienced clinically meaningful reduction in A1C, 10.1 (SD 1.7) to 9.6 (SD 1.9) and 9.8 (SD 1.7) to 9.1 (SD 1.9) respectively, p = 0.004. Participants in the intervention group experienced a significantly larger reduction in diabetes distress compared to the control, 2.7 (SD 1.2) to 2.1 (1.0) versus 2.6 (SD 1.1) to 2.3 (SD 1.0) p = 0.041.
CONCLUSIONS


Community-based DSME with and without peer support led to improved glycemic control. Peer support linked to clinical care led to a larger reduction in diabetes distress, which has important implications for the overall wellbeing of adults with type 2 diabetes.",2020,"Participants in the intervention group experienced a significantly larger reduction in diabetes distress compared to the control, 2.7 (SD 1.2) to 2.1 (1.0) versus 2.6 (SD 1.1) to 2.3 (SD 1.0) p = 0.041.
","['African Americans with Type 2 Diabetes', 'Of 120 participants randomized, 97 completed the study', '19\xa0years, receiving care within a safety-net healthcare system in Jefferson County, Alabama, with a diagnosis of type 2 diabetes and a hemoglobin A1c (A1C) ≥\u20097.5', 'adults with type 2 diabetes', 'African American adults with poorly controlled type 2 diabetes', 'African American adults, age\xa0']","[""community-based diabetes self-management education (DSME) plus 6\xa0months of mHealth-enhanced peer support, including 12 weekly phone calls, then 3 monthly calls from community health workers, who used a novel web application to communicate with participants' healthcare teams"", 'Mobile-Enhanced Peer Support', 'community-based diabetes self-management education (DSME) plus mobile health (mHealth)-enhanced peer support intervention to community-based diabetes self-management education (DSME) alone', 'community-based DSME alone']","['glycemic control', 'diabetes distress, depressive symptoms, self-efficacy or confidence in their ability to manage diabetes, and social support', 'diabetes distress']","[{'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0018696', 'cui_str': 'Healthcare Systems'}, {'cui': 'C0001895', 'cui_str': 'Alabama'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1319140', 'cui_str': 'Diabetes self-management behavior'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0205196', 'cui_str': 'Communicating'}, {'cui': 'C0086390', 'cui_str': 'Health Care Team'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0037438', 'cui_str': 'Social support'}]",120.0,0.0921981,"Participants in the intervention group experienced a significantly larger reduction in diabetes distress compared to the control, 2.7 (SD 1.2) to 2.1 (1.0) versus 2.6 (SD 1.1) to 2.3 (SD 1.0) p = 0.041.
","[{'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Presley', 'Affiliation': 'Division of Preventive Medicine, Department of Medicine, School of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA. capresley@uabmc.edu.'}, {'ForeName': 'April', 'Initials': 'A', 'LastName': 'Agne', 'Affiliation': 'Division of Preventive Medicine, Department of Medicine, School of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Shelton', 'Affiliation': 'Cooper Green Mercy Health Services, Birmingham, AL, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Oster', 'Affiliation': 'Division of Preventive Medicine, Department of Medicine, School of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Cherrington', 'Affiliation': 'Division of Preventive Medicine, Department of Medicine, School of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.'}]",Journal of general internal medicine,['10.1007/s11606-020-06011-w']
2346,32702360,Comparison of Long-Term Rotational Stability of Three Commonly Implanted Intraocular Lenses.,"PURPOSE


To compare rotational stability and its influencing factors in 3 different widely used hydrophobic acrylic intraocular lenses (IOLs) from the end of surgery (EoS) to 4-7 months (6 months) in over 380 eyes.
DESIGN


Prospective interventional comparative clinical study.
METHODS


Setting: Department of Ophthalmology, Medical University of Vienna.
PATIENT POPULATION


A total of 381 eyes of 199 patients with age-related cataract received an IOL Acrysof SN60WF, Tecnis ZCB00, or Envista MX60 in a consecutive order.
INTERVENTION


Implantation of an Acrysof, Tecnis, or Envista IOL randomized to the 0 ± 10, 45 ± 10, 90 ± 10, or 135 ± 10° axis in 1 or both eyes. Baseline measurement was performed with patients supine still on the operating table. Postoperative follow-ups were conducted after 1 hour, 1 week, 1 month, and 6 months.
MAIN OUTCOME MEASURES


Difference of absolute rotation from the EoS to 6 months.
RESULTS


Absolute rotations from the EoS to 6 months were 1.65 ± 2.1, 2.65 ± 4.1, and 3.18 ± 5.8° for the Acrysof, Tecnis, and Envista group, respectively. Rotational stability was statistically significantly superior in the Acrysof compared with the Envista group (P = .014), but not compared with the Tecnis group (P = .10). No significant difference was found between the Tecnis and Envista groups (P = .761). Maximum values of 15.8, 38.6, and 44.9° were observed for the Acrysof, Tecnis, and Envista group, respectively.
CONCLUSION


The Acrysof IOL showed the least amount of absolute rotation compared with the Tecnis and Envista IOLs. Outliers possibly requiring secondary intervention were observed in all groups. The amount of rotation was greatest during the first postoperative hour.",2020,"Rotational stability was statistically significantly superior in the Acrysof compared to the Envista group (p=0.014), but not compared to the Tecnis group (p=0.10).",['Medical University of Vienna PATIENT POPULATION: 381 eyes of 199 patients with age-related cataract received an'],"['hydrophobic acrylic intraocular lenses (IOL', 'IOL Acrysof SN60WF, Tecnis ZCB00 or Envista MX60']",['Rotational stability'],"[{'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C4708787', 'cui_str': '381'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086543', 'cui_str': 'Cataract'}]","[{'cui': 'C0598629', 'cui_str': 'Hydrophobicity'}, {'cui': 'C0440181', 'cui_str': 'Acrylic dental material'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}]","[{'cui': 'C0445237', 'cui_str': 'Rotational'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]",199.0,0.0268413,"Rotational stability was statistically significantly superior in the Acrysof compared to the Envista group (p=0.014), but not compared to the Tecnis group (p=0.10).","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Schartmüller', 'Affiliation': 'Department of Ophthalmology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Schwarzenbacher', 'Affiliation': 'Department of Ophthalmology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Elias Laurin', 'Initials': 'EL', 'LastName': 'Meyer', 'Affiliation': 'Section for Medical Statistics, Center for Medical Statistics, Informatics and Intelligent Systems, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Schriefl', 'Affiliation': 'Department of Ophthalmology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Leydolt', 'Affiliation': 'Department of Ophthalmology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Rupert', 'Initials': 'R', 'LastName': 'Menapace', 'Affiliation': 'Department of Ophthalmology, Medical University of Vienna, Vienna, Austria. Electronic address: rupert.menapace@meduniwien.ac.at.'}]",American journal of ophthalmology,['10.1016/j.ajo.2020.07.019']
2347,32703974,"Functional high-intensity exercise is more effective in acutely increasing working memory than aerobic walking: an exploratory randomized, controlled trial.","Aerobic and resistance exercise acutely increase cognitive performance (CP). High-intensity functional training (HIFT) combines the characteristics of both regimes but its effect on CP is unclear. Thirty-five healthy individuals (26.7 ± 3.6 years, 18 females) were randomly allocated to three groups. The first (HIFT) performed a functional whole-body workout at maximal effort and in circuit format, while a second walked at 60% of the heart rate reserve (WALK). The third group remained physically inactive reading a book (CON). Before and after the 15-min intervention period, CP was assessed with the Stroop Test, Trail Making Test and Digit Span Test. Repeated-measures ANOVAs and post-hoc 95% confidence intervals (95% CI) were used to detect time/group differences. A significant group*time interaction was found for the backwards condition of the Digit Span Test (p = 0.04) and according to the 95% CI, HIFT was superior to WALK and CON. Analysis of the sum score of the Digit Span Test and the incongruent condition of the Stroop Test, furthermore, revealed main effects for time (p < 0.05) with HIFT being the only intervention improving CP. No differences were found for the Trail Making Test (p > 0.05). In conclusion, HIFT represents an appropriate method to acutely improve working memory, potentially being superior to moderate aerobic-type exercise.",2020,No differences were found for the Trail Making Test (p > 0.05).,"['Thirty-five healthy individuals (26.7\u2009±\u20093.6\xa0years, 18 females']","['Aerobic and resistance exercise', 'HIFT', 'Functional high-intensity exercise', 'High-intensity functional training (HIFT']","['cognitive performance (CP', 'Stroop Test, Trail Making Test and Digit Span Test', 'physically inactive reading a book (CON']","[{'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4517694', 'cui_str': '3.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]","[{'cui': 'C2718024', 'cui_str': 'Stroop Task'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0006002', 'cui_str': 'Book'}]",35.0,0.0307978,No differences were found for the Trail Making Test (p > 0.05).,"[{'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Wilke', 'Affiliation': 'Department of Sports Medicine, Goethe University Frankfurt am Main, Ginnheimer Landstraße 39, 60487, Frankfurt am Main, Germany. wilke@sport.uni-frankfurt.de.'}]",Scientific reports,['10.1038/s41598-020-69139-z']
2348,32704023,"Soluble Klotho, a biomarker and therapeutic strategy to reduce bronchopulmonary dysplasia and pulmonary hypertension in preterm infants.","Preterm infants with bronchopulmonary dysplasia (BPD) and pulmonary hypertension (PH) have accelerated lung aging and poor long-term outcomes. Klotho is an antiaging protein that modulates oxidative stress, angiogenesis and fibrosis. Here we test the hypothesis that decreased cord Klotho levels in preterm infants predict increased BPD-PH risk and early Klotho supplementation prevents BPD-like phenotype and PH in rodents exposed to neonatal hyperoxia. In experiment 1, Klotho levels were measured in cord blood of preterm infants who were enrolled in a longitudinal cohort study. In experiment 2, using an experimental BPD-PH model, rat pups exposed to room air or hyperoxia (85% O 2 ) were randomly assigned to receive every other day injections of recombinant Klotho or placebo. The effect of Klotho on lung structure, PH and cardiac function was assessed. As compared to controls, preterm infants with BPD or BPD-PH had decreased cord Klotho levels. Early Klotho supplementation in neonatal hyperoxia-exposed rodents preserved lung alveolar and vascular structure, attenuated PH, reduced pulmonary vascular remodeling and improved cardiac function. Together, these findings have important implications as they suggest that perinatal Klotho deficiency contributes to BPD-PH risk and strategies that preserve Klotho levels, may improve long-term cardiopulmonary outcomes in preterm infants.",2020,"As compared to controls, preterm infants with BPD or BPD-PH had decreased cord Klotho levels.","['Preterm infants with bronchopulmonary dysplasia (BPD) and pulmonary hypertension (PH', 'rat pups exposed to room air or hyperoxia (85% O 2 ', 'preterm infants']","['Klotho', 'recombinant Klotho or placebo']","['bronchopulmonary dysplasia and pulmonary hypertension', 'lung structure, PH and cardiac function', 'cord Klotho levels', 'Klotho levels', 'neonatal hyperoxia-exposed rodents preserved lung alveolar and vascular structure, attenuated PH, reduced pulmonary vascular remodeling and improved cardiac function']","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0006287', 'cui_str': 'Bronchopulmonary dysplasia of newborn'}, {'cui': 'C0020542', 'cui_str': 'Pulmonary hypertension'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0242706', 'cui_str': 'Hyperoxia'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}]","[{'cui': 'C1144173', 'cui_str': 'KL protein, human'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0006287', 'cui_str': 'Bronchopulmonary dysplasia of newborn'}, {'cui': 'C0020542', 'cui_str': 'Pulmonary hypertension'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C3489532', 'cui_str': 'Cone-Rod Dystrophy 2'}, {'cui': 'C1144173', 'cui_str': 'KL protein, human'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0242706', 'cui_str': 'Hyperoxia'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0035804', 'cui_str': 'Order Rodentia'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C3850148', 'cui_str': 'Vascular Remodeling'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",,0.0610072,"As compared to controls, preterm infants with BPD or BPD-PH had decreased cord Klotho levels.","[{'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Batlahally', 'Affiliation': 'Department of Pediatrics, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Franklin', 'Affiliation': ""Ann & Robert H. Lurie Children's Hospital of Chicago, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.""}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Damianos', 'Affiliation': 'Department of Pediatrics, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Department of Pediatrics, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Pingping', 'Initials': 'P', 'LastName': 'Chen', 'Affiliation': 'Department of Pediatrics, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Mayank', 'Initials': 'M', 'LastName': 'Sharma', 'Affiliation': 'Department of Pediatrics, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Duara', 'Affiliation': 'Department of Pediatrics, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Divya', 'Initials': 'D', 'LastName': 'Keerthy', 'Affiliation': 'Department of Pediatrics, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Zambrano', 'Affiliation': 'Department of Pediatrics, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Lina A', 'Initials': 'LA', 'LastName': 'Shehadeh', 'Affiliation': 'The Interdisciplinary Stem Cell Institute, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Eliana C', 'Initials': 'EC', 'LastName': 'Martinez', 'Affiliation': 'Department of Pediatrics, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Marissa J', 'Initials': 'MJ', 'LastName': 'DeFreitas', 'Affiliation': 'Department of Pediatrics, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Shathiyah', 'Initials': 'S', 'LastName': 'Kulandavelu', 'Affiliation': 'Department of Pediatrics, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Carolyn L', 'Initials': 'CL', 'LastName': 'Abitbol', 'Affiliation': 'Department of Pediatrics, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Freundlich', 'Affiliation': 'Department of Pediatrics, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Rosemeire M', 'Initials': 'RM', 'LastName': 'Kanashiro-Takeuchi', 'Affiliation': 'The Interdisciplinary Stem Cell Institute, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Augusto', 'Initials': 'A', 'LastName': 'Schmidt', 'Affiliation': 'Department of Pediatrics, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Merline', 'Initials': 'M', 'LastName': 'Benny', 'Affiliation': 'Department of Pediatrics, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Shu', 'Initials': 'S', 'LastName': 'Wu', 'Affiliation': 'Department of Pediatrics, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Karen K', 'Initials': 'KK', 'LastName': 'Mestan', 'Affiliation': ""Ann & Robert H. Lurie Children's Hospital of Chicago, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.""}, {'ForeName': 'Karen C', 'Initials': 'KC', 'LastName': 'Young', 'Affiliation': 'Department of Pediatrics, University of Miami Miller School of Medicine, Miami, FL, USA. Kyoung3@med.miami.edu.'}]",Scientific reports,['10.1038/s41598-020-69296-1']
2349,32704082,Green-banana biomass consumption by diabetic patients improves plasma low-density lipoprotein particle functionality.,"The aim of this study was to investigate the effects of 6-months consumption of green-banana biomass on the LDL particle functionality in subjects with type 2 diabetes. Subjects (n = 39, mean age 65 years old) of both sexes with diabetes (HbA1c ≥ 6·5%) were randomized to receive nutritional support plus green-banana biomass (40 g) (n = 21) or diet alone (n = 18) for 6-months. Non-linear optical responses of LDL solutions from these participants were studied by Z-scan technique. UV-visible spectrophotometer was used to measure the absorbance of the LDL samples. Small Angle X-ray Scattering and Dynamic Light Scattering experiments were used to look for any structural changes in LDL samples and to determine their size distribution. The Lipoprint test was used to determine the LDL sub-fractions in terms of distribution and size. Consumption of green-banana biomass, reduced total- (p = 0.010), non-HDL-cholesterol (p = 0.043), glucose (p = 0.028) and HbA1c (p = 0.0007), and also improved the protection of the LDL particle against oxidation, by the increase in carotenoids content in the particles (p = 0.007). This higher protection against modifications may decrease the risk of developing cardiovascular disease. These benefits of the green-banana biomass encourage the use of resistant starches with potential clinical applications in individuals with pre-diabetes and diabetes.",2020,Small Angle X-ray Scattering and Dynamic Light Scattering experiments were used to look for any structural changes in LDL samples and to determine their size distribution.,"['individuals with pre-diabetes and diabetes', 'subjects with type 2 diabetes', 'Subjects (n\u2009=\u200939, mean age 65\xa0years old) of both sexes with diabetes (HbA1c\u2009≥\u20096·5']","['6-months consumption of green-banana biomass', 'nutritional support plus green-banana biomass (40\xa0g) (n\u2009=\u200921) or diet alone']","['LDL particle functionality', 'Consumption of green-banana biomass, reduced total- ', 'plasma low-density lipoprotein particle functionality', 'non-HDL-cholesterol', 'carotenoids content', 'protection of the LDL particle against oxidation']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0332583', 'cui_str': 'Green color'}, {'cui': 'C0004722', 'cui_str': 'Banana'}, {'cui': 'C0005535', 'cui_str': 'Biomass'}, {'cui': 'C0242739', 'cui_str': 'Nutritional support'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0332583', 'cui_str': 'Green color'}, {'cui': 'C0004722', 'cui_str': 'Banana'}, {'cui': 'C0005535', 'cui_str': 'Biomass'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0729627', 'cui_str': 'Non-HDL cholesterol'}, {'cui': 'C0007271', 'cui_str': 'Carotinoid'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}]",,0.0222308,Small Angle X-ray Scattering and Dynamic Light Scattering experiments were used to look for any structural changes in LDL samples and to determine their size distribution.,"[{'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Lotfollahi', 'Affiliation': 'Complex Fluids Group, Instituto de Física, Universidade de São Paulo, Rua Do Matão, 1371, Butantã, São Paulo, SP, CEP: 05508-090, Brazil.'}, {'ForeName': 'Ana Paula de Queiroz', 'Initials': 'APQ', 'LastName': 'Mello', 'Affiliation': 'University Center São Camilo, São Paulo, Brazil.'}, {'ForeName': 'Edna S', 'Initials': 'ES', 'LastName': 'Costa', 'Affiliation': 'Federal University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Cristiano L P', 'Initials': 'CLP', 'LastName': 'Oliveira', 'Affiliation': 'Complex Fluids Group, Instituto de Física, Universidade de São Paulo, Rua Do Matão, 1371, Butantã, São Paulo, SP, CEP: 05508-090, Brazil.'}, {'ForeName': 'Nagila R T', 'Initials': 'NRT', 'LastName': 'Damasceno', 'Affiliation': 'Faculty of Public Health, University of São Paulo (USP), São Paulo, Brazil.'}, {'ForeName': 'Maria Cristina', 'Initials': 'MC', 'LastName': 'Izar', 'Affiliation': 'Federal University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Antonio Martins Figueiredo', 'Initials': 'AMF', 'LastName': 'Neto', 'Affiliation': 'Complex Fluids Group, Instituto de Física, Universidade de São Paulo, Rua Do Matão, 1371, Butantã, São Paulo, SP, CEP: 05508-090, Brazil. afigueiredo@if.usp.br.'}]",Scientific reports,['10.1038/s41598-020-69288-1']
2350,32704155,Effects of movement representation techniques on motor learning of thumb-opposition tasks.,"The present work is the first study that assess long run change after motor learning. The study's main objective was to evaluate the short to medium-term impact of motor imagery (MI) and action observation (AO) on motor learning of a sequence of thumb-opposition tasks of increasing complexity. We randomly assigned 45 participants to an AO, MI, or placebo observation (PO) group. A sequence of 12 thumb-opposition tasks was taught for 3 consecutive days (4 per day). The primary outcome was accuracy. The secondary outcomes were required time and perfect positioning. The outcomes were assessed immediately after the intervention and at 1 week, 1 month and 4 months postintervention. Regarding the primary outcome, AO group had significantly higher accuracy than the MI or PO group until at least 4 months (p < 0.01, d > 0.80). However, in the bimanual positions, AO was not superior to MI at 1 week postintervention. Regarding secondary outcomes, AO group required less time than the MI group to remember and perform the left-hand and both-hand gestures, with a large effect size (p < 0.01, d > 0.80). In terms of percentage of perfect positions, AO group achieved significantly better results than the MI group until at least 4 months after the intervention in the unimanual gestures (p < 0.01, d > 0.80) and up to 1 month postintervention in the bimanual gestures (p = 0.012, d = 1.29). AO training resulted in greater and longer term motor learning than MI and placebo intervention. If the goal is to learn some motor skills for whatever reason (e.g., following surgery or immobilization.), AO training should be considered clinically.",2020,"In terms of percentage of perfect positions, AO group achieved significantly better results than the MI group until at least 4 months after the intervention in the unimanual gestures (p < 0.01, d > 0.80) and up to 1 month postintervention in the bimanual gestures (p = 0.012, d = 1.29).",[],"['AO, MI, or placebo observation (PO', 'AO training', 'movement representation techniques', 'motor imagery (MI) and action observation (AO']","['required time and perfect positioning', 'longer term motor learning', 'motor learning of thumb-opposition tasks']",[],"[{'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0150305', 'cui_str': 'Positioning - therapy'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0427082', 'cui_str': 'Opposition of thumb'}]",45.0,0.0563366,"In terms of percentage of perfect positions, AO group achieved significantly better results than the MI group until at least 4 months after the intervention in the unimanual gestures (p < 0.01, d > 0.80) and up to 1 month postintervention in the bimanual gestures (p = 0.012, d = 1.29).","[{'ForeName': 'Ferran', 'Initials': 'F', 'LastName': 'Cuenca-Martínez', 'Affiliation': 'Departmento de Fisioterapia, Centro Superior de Estudios Universitarios CSEU La Salle, Universidad Autónoma de Madrid, Madrid, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Suso-Martí', 'Affiliation': 'Motion in Brains Research Group, Institute of Neuroscience and Sciences of the Movement (INCIMOV), Centro Superior de Estudios Universitarios CSEU La Salle, Universidad Autónoma de Madrid, Madrid, Spain.'}, {'ForeName': 'Jose Vicente', 'Initials': 'JV', 'LastName': 'León-Hernández', 'Affiliation': 'Departmento de Fisioterapia, Centro Superior de Estudios Universitarios CSEU La Salle, Universidad Autónoma de Madrid, Madrid, Spain.'}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'La Touche', 'Affiliation': 'Departmento de Fisioterapia, Centro Superior de Estudios Universitarios CSEU La Salle, Universidad Autónoma de Madrid, Madrid, Spain. roylatouche@yahoo.es.'}]",Scientific reports,['10.1038/s41598-020-67905-7']
2351,32707325,"Eclipse stemless shoulder prosthesis vs. Univers II shoulder prosthesis: a multicenter, prospective randomized controlled trial.","BACKGROUND


Total shoulder arthroplasty is an accepted treatment for glenohumeral osteoarthritis. The Arthrex Eclipse shoulder prosthesis is a stemless, canal-sparing humeral prosthesis with bone ingrowth capacity on the trunnion, as well as through the fenestrated hollow screw, that provides both diaphyseal and metaphyseal load sharing and fixation.
METHODS


Between 2013 and 2018, 16 sites in the United States enrolled 327 patients (Eclipse in 237 and Arthrex Univers II in 90). All patients had glenohumeral arthritis refractory to nonsurgical care. Strict exclusion criteria were applied to avoid confounding factors such as severe patient comorbidities, arthritis not consistent with osteoarthritis, and medical or prior surgical treatments that may have affected outcomes. Patients were randomized to the Eclipse or Univers II group via block randomization.
RESULTS


In total, 149 Eclipse and 76 Univers II patients reached 2-year follow-up (139 Eclipse patients [93.3%] and 68 Univers II patients [89.5%] had complete data). The success rate using the Composite Clinical Success score was 95% in the Eclipse group vs. 89.7% in the Univers II group. No patient exhibited radiographic evidence of substantial humeral radiolucency, humeral migration, or subsidence at any point. Reoperations were performed in 7 patients (3.2%) in the Eclipse group and 3 (3.8%) in the Univers II group.
CONCLUSION


The Arthrex Eclipse shoulder prosthesis is a safe and effective humeral implant for patients with glenohumeral arthritis at 2-year follow-up, with no differences in outcomes compared with the Univers II shoulder prosthesis.",2020,"The Arthrex Eclipse shoulder prosthesis is a safe and effective humeral implant for patients with glenohumeral arthritis at two-year follow-up with no differences in outcomes when compared to the Univers II.
","['16 sites in the United States enrolled 327 patients (237 Eclipse, 90 Univers II) between 2013-2019', 'glenohumeral osteoarthritis', 'All patients had glenohumeral arthritis refractory to non-surgical care']",['Eclipse Stemless Shoulder Prosthesis versus Univers II Shoulder Prosthesis'],['success rate using the composite clinical success (CCS) score'],"[{'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0003864', 'cui_str': 'Arthritis'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}]","[{'cui': 'C1961833', 'cui_str': 'Artificial Shoulder Joint'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",327.0,0.112073,"The Arthrex Eclipse shoulder prosthesis is a safe and effective humeral implant for patients with glenohumeral arthritis at two-year follow-up with no differences in outcomes when compared to the Univers II.
","[{'ForeName': 'Anthony A', 'Initials': 'AA', 'LastName': 'Romeo', 'Affiliation': 'Department of Orthopaedic Surgery, Rothman Orthopaedic Institute-New York, New York, NY, USA.'}, {'ForeName': 'Brandon J', 'Initials': 'BJ', 'LastName': 'Erickson', 'Affiliation': 'Department of Orthopaedic Surgery, Rothman Orthopaedic Institute-New York, New York, NY, USA. Electronic address: brandon.j.erickson@gmail.com.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Costouros', 'Affiliation': 'Department of Orthopaedic Surgery, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Long', 'Affiliation': 'Bone and Joint Center, Columbus, OH, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Klassen', 'Affiliation': 'Essentia Health Duluth, Duluth, MN, USA.'}, {'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Araghi', 'Affiliation': 'Banner Research, Sun City, AZ, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Brown', 'Affiliation': 'Banner Research, Sun City, AZ, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Setter', 'Affiliation': 'The Research Foundation for The State University of New York, Syracuse, NY, USA.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Port', 'Affiliation': 'Altoona Regional Health System, Altoona, PA, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Tyndall', 'Affiliation': 'Altoona Regional Health System, Altoona, PA, USA.'}, {'ForeName': 'Nikhil N', 'Initials': 'NN', 'LastName': 'Verma', 'Affiliation': 'Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, IL, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Sears', 'Affiliation': 'Rose Medical Center, Denver, CO, USA.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Brandon', 'Affiliation': 'Peninsula Regional Medical Center, Salisbury, MD, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Smith', 'Affiliation': 'Ellis and Badenhausen Orthopedics, Louisville, KY, USA.'}, {'ForeName': 'Earl', 'Initials': 'E', 'LastName': 'McFadden', 'Affiliation': 'Palmetto Health Orthopedics, Columbia, SC, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Patterson', 'Affiliation': 'Excelsior Orthopedics, Buffalo, NY, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Stein', 'Affiliation': 'Union Memorial Hospital, Baltimore, MD, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Cohen', 'Affiliation': 'Adena Regional Medical Center, Chillicothe, OH, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Abboud', 'Affiliation': 'Department of Orthopaedic Surgery, Rothman Orthopaedic Institute, Philadelphia, PA, USA.'}]",Journal of shoulder and elbow surgery,['10.1016/j.jse.2020.07.004']
2352,32720188,Changes in Family-Level Attitudes and Norms and Association with Secondary School Completion and Child Marriage Among Adolescent Girls: Results from an Exploratory Study Nested Within a Cluster-Randomised Controlled Trial in India.,"We evaluated the impact of Samata, a 3-year multilayered intervention among scheduled caste/scheduled tribe (SC/ST) adolescent girls in rural northern Karnataka, on family-level (parents or guardian) attitudes and direct and indirect norms related to child marriage and girl's education. Endline data from 1840 family members were used to assess the effect of Samata on attitudes and norms related to schooling and child marriage, while data from 4097 family members (including 2257 family members at baseline) were used to understand the shifts in attitudes and norms over the period 2014-2017. Overall, we found that the programme had little impact on family-level attitudes and norms. However, there were shifts in some attitudes, norms and perceived sanctions between baseline (when girls were aged 13-14 years) and endline (when girls were aged 15-16 years), with some becoming more progressive (e.g. direct norms related to child marriage) and others more restrictive (e.g. norms around girls completing secondary education and norms related to child marriage and educational drop-out, blaming girls for eve teasing and limiting girls' mobility so as to protect family honour). Moreover, non-progressive norms related to marriage and education were strongly associated with child marriage and secondary school non-completion among adolescent girls in this rural setting. Norms hypothesised to be important for marriage and schooling outcomes were indeed associated with these outcomes, but the intervention was not able to significantly shift these norms. In part, this may have been due to the intervention focusing much of its initial efforts on working with girls alone rather than family members, the relevant reference group. Future interventions that seek to affect norms should conduct formative research to clarify the specific norms affecting the outcome(s) of interest; likewise, programme planners should ensure that all activities engage those most influential in enforcing the norm(s) from the beginning. ClinicalTrials.gov registration number: NCT01996241.",2020,"Moreover, non-progressive norms related to marriage and education were strongly associated with child marriage and secondary school non-completion among adolescent girls in this rural setting.","['Adolescent Girls', ""girls were aged 13-14\xa0years) and endline (when girls were aged 15-16\xa0years), with some becoming more progressive (e.g. direct norms related to child marriage) and others more restrictive (e.g. norms around girls completing secondary education and norms related to child marriage and educational drop-out, blaming girls for eve teasing and limiting girls' mobility so as to protect family honour"", '4097 family members (including 2257 family members at baseline', '1840 family members', ""scheduled caste/scheduled tribe (SC/ST) adolescent girls in rural northern Karnataka, on family-level (parents or guardian) attitudes and direct and indirect norms related to child marriage and girl's education""]",[],['Changes in Family-Level Attitudes and Norms and Association with Secondary School Completion and Child Marriage'],"[{'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0237750', 'cui_str': 'Societal Norms'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0024841', 'cui_str': 'Marriage'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0047006', 'cui_str': 'Methylenedioxyethylamphetamine'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0007337', 'cui_str': 'Caste'}, {'cui': 'C0040881', 'cui_str': 'Tribes'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0023226', 'cui_str': 'Legal guardian'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0439852', 'cui_str': 'Indirect'}]",[],"[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0237750', 'cui_str': 'Societal Norms'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0036530', 'cui_str': 'Secondary school'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0024841', 'cui_str': 'Marriage'}]",,0.028237,"Moreover, non-progressive norms related to marriage and education were strongly associated with child marriage and secondary school non-completion among adolescent girls in this rural setting.","[{'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Prakash', 'Affiliation': 'Department of Community Health Sciences, Institute for Global Public Health, University of Manitoba, R070 Med Rehab Bldg, 771 McDermot Avenue, Winnipeg, Manitoba, R3E 0T6, Canada. ravi.prakash@ihat.in.'}, {'ForeName': 'Tara S', 'Initials': 'TS', 'LastName': 'Beattie', 'Affiliation': 'Departments of Global Health and Development and Public Health, Environments and Society, London School of Hygiene & Tropical Medicine (LSHTM), 15-17 Tavistock Place, London, UK.'}, {'ForeName': 'Beniamino', 'Initials': 'B', 'LastName': 'Cislaghi', 'Affiliation': 'Departments of Global Health and Development and Public Health, Environments and Society, London School of Hygiene & Tropical Medicine (LSHTM), 15-17 Tavistock Place, London, UK.'}, {'ForeName': 'Parinita', 'Initials': 'P', 'LastName': 'Bhattacharjee', 'Affiliation': 'Department of Community Health Sciences, Institute for Global Public Health, University of Manitoba, R070 Med Rehab Bldg, 771 McDermot Avenue, Winnipeg, Manitoba, R3E 0T6, Canada.'}, {'ForeName': 'Prakash', 'Initials': 'P', 'LastName': 'Javalkar', 'Affiliation': 'Karnataka Health Promotion Trust (KHPT), Bangalore, India.'}, {'ForeName': 'Satyanarayana', 'Initials': 'S', 'LastName': 'Ramanaik', 'Affiliation': 'Karnataka Health Promotion Trust (KHPT), Bangalore, India.'}, {'ForeName': 'Raghavendra', 'Initials': 'R', 'LastName': 'Thalinja', 'Affiliation': 'Karnataka Health Promotion Trust (KHPT), Bangalore, India.'}, {'ForeName': 'Calum', 'Initials': 'C', 'LastName': 'Davey', 'Affiliation': 'Departments of Global Health and Development and Public Health, Environments and Society, London School of Hygiene & Tropical Medicine (LSHTM), 15-17 Tavistock Place, London, UK.'}, {'ForeName': 'Mitzy', 'Initials': 'M', 'LastName': 'Gafos', 'Affiliation': 'Departments of Global Health and Development and Public Health, Environments and Society, London School of Hygiene & Tropical Medicine (LSHTM), 15-17 Tavistock Place, London, UK.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Watts', 'Affiliation': 'Departments of Global Health and Development and Public Health, Environments and Society, London School of Hygiene & Tropical Medicine (LSHTM), 15-17 Tavistock Place, London, UK.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Collumbien', 'Affiliation': 'Departments of Global Health and Development and Public Health, Environments and Society, London School of Hygiene & Tropical Medicine (LSHTM), 15-17 Tavistock Place, London, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Moses', 'Affiliation': 'Department of Community Health Sciences, Institute for Global Public Health, University of Manitoba, R070 Med Rehab Bldg, 771 McDermot Avenue, Winnipeg, Manitoba, R3E 0T6, Canada.'}, {'ForeName': 'Shajy', 'Initials': 'S', 'LastName': 'Isac', 'Affiliation': 'Department of Community Health Sciences, Institute for Global Public Health, University of Manitoba, R070 Med Rehab Bldg, 771 McDermot Avenue, Winnipeg, Manitoba, R3E 0T6, Canada.'}, {'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Heise', 'Affiliation': 'Departments of Global Health and Development and Public Health, Environments and Society, London School of Hygiene & Tropical Medicine (LSHTM), 15-17 Tavistock Place, London, UK.'}]",Prevention science : the official journal of the Society for Prevention Research,['10.1007/s11121-020-01143-1']
2353,32720190,Effects of Therapeutic Intervention on Parentally Bereaved Children's Emotion Reactivity and Regulation 15 Years Later.,"The Family Bereavement Program (FBP) is a family-based intervention for parentally bereaved children and surviving caregivers. Results are reported of a randomized controlled trial, examining intervention effects on emotional reactivity and regulation of young adults who participated in the program 15 years earlier. Participants (N = 152) completed four emotion challenge tasks: reactivity to negative images, detached reappraisal while viewing negative images, positive reappraisal while viewing negative images, and reengagement with positive images. Outcomes included cardiac interbeat interval (IBI), pre-ejection period (PEP), and respiratory sinus arrhythmia (RSA) as well as self-reported emotional experience and regulation effectiveness. Direct intervention effects and effects mediated through improved parenting were estimated. Several significant effects were observed in primary analyses; however, none remained significant after correction for familywise Type I error. Parenting mediated FBP effects on IBI during negative reactivity (b = 15.04), and on RSA during positive reengagement (b = 0.35); the latter effect was accounted for by changes in breathing. Intervention condition was a direct predictor of self-reported detached reappraisal effectiveness (b = 1.00). Intervention and gender interacted in predicting self-reported negative emotion during the negative reactivity (b = 1.04) and positive reappraisal tasks (b = 1.31) such that intervention-condition men reported more negative emotions during those tasks. Although these findings should be considered preliminary given the limited power of the corrected statistical tests, they suggest long-term effects of family intervention following the death of a parent on offspring's emotional reactivity and regulation ability that should be pursued further in future research.",2020,Intervention condition was a direct predictor of self-reported detached reappraisal effectiveness (b = 1.00).,"['young adults who participated in the program 15\xa0years earlier', 'Participants (N\u2009=\u2009152) completed four', ""Parentally Bereaved Children's Emotion Reactivity and Regulation 15\xa0Years Later""]","['emotion challenge tasks: reactivity to negative images, detached reappraisal while viewing negative images, positive reappraisal while viewing negative images, and reengagement with positive images', 'Family Bereavement Program (FBP', 'Therapeutic Intervention']","['emotional reactivity and regulation', 'cardiac interbeat interval (IBI), pre-ejection period (PEP), and respiratory sinus arrhythmia (RSA) as well as self-reported emotional experience and regulation effectiveness', 'negative emotions', 'positive reappraisal tasks']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0205087', 'cui_str': 'Late'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0860659', 'cui_str': 'Aloof'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0425043', 'cui_str': 'Death of relative'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0336969', 'cui_str': 'Ejection'}, {'cui': 'C0003813', 'cui_str': 'Sinus arrhythmia'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1446409', 'cui_str': 'Positive'}]",,0.0281621,Intervention condition was a direct predictor of self-reported detached reappraisal effectiveness (b = 1.00).,"[{'ForeName': 'Alexander F', 'Initials': 'AF', 'LastName': 'Danvers', 'Affiliation': 'Department of Psychology, University of Arizona, Tucson, AZ, 85721, USA.'}, {'ForeName': 'Brandon G', 'Initials': 'BG', 'LastName': 'Scott', 'Affiliation': 'Department of Psychology, Montana State University, Culbertson Hall, 100, Bozeman, MT, 59717, USA.'}, {'ForeName': 'Michelle N', 'Initials': 'MN', 'LastName': 'Shiota', 'Affiliation': 'Department of Psychology, Arizona State University, P.O. Box 871104, Tempe, AZ, 85287-1104, USA. lani.shiota@asu.edu.'}, {'ForeName': 'Jenn-Yun', 'Initials': 'JY', 'LastName': 'Tein', 'Affiliation': 'Department of Psychology, Arizona State University, P.O. Box 871104, Tempe, AZ, 85287-1104, USA.'}, {'ForeName': 'Sharlene A', 'Initials': 'SA', 'LastName': 'Wolchik', 'Affiliation': 'Department of Psychology, Arizona State University, P.O. Box 871104, Tempe, AZ, 85287-1104, USA.'}, {'ForeName': 'Irwin I', 'Initials': 'II', 'LastName': 'Sandler', 'Affiliation': 'Department of Psychology, Arizona State University, P.O. Box 871104, Tempe, AZ, 85287-1104, USA.'}]",Prevention science : the official journal of the Society for Prevention Research,['10.1007/s11121-020-01142-2']
2354,32725772,"Associations between muscle measures, survival, and toxicity in patients with limited stage small cell lung cancer.","BACKGROUND


Standard treatment for patients with limited stage small cell lung cancer (LS SCLC) is concurrent platinum-etoposide chemotherapy and thoracic radiotherapy (TRT). Up to 30% of patients are cured, but severe toxicity is common, and we are not able to identify those who are cured or those who experience severe toxicity before chemoradiotherapy commences. Studies of other cancer patients show that low muscle mass and muscle radiodensity are associated with inferior survival and that a high drug dose per kilogram lean body mass (LBM) is associated with more toxicity, but this has not been investigated in LS SCLC. We analysed patients from a randomized trial comparing two schedules of TRT (n = 157) to investigate the prognostic and predictive role of these muscle measures in LS SCLC.
METHODS


Patients from a trial comparing once daily hypofractionated with twice daily hyperfractionated TRT were analysed. The skeletal muscle index (SMI), skeletal muscle radiodensity (SMD), and LBM were assessed from baseline computed tomography scans at the L3 level using the SliceOMatic software.
RESULTS


Images at the L3 level were available for 122 patients (77.7%). Median age was 64 years, 18% had performance status 2, and 38% had stage III. Grade 3-4 toxicity was observed in 89%, and 5% died from treatment-related side effects. Overall, the median overall survival was 23 months, and the 5 year survival was 25%. Median LBM was 45.2 (range: 16-65) kg, the median SMI 44.8 (range: 29-77) cm 2  /m 2  , and the median SMD 39.3 (range 16-62) HU. There were no significant associations between survival and any of the muscle measures in the univariable analyses (SMI: P = 0.906, SMD: P = 0.829) or in multivariable analyses adjusting for baseline characteristics (SMI: P = 0.836, SMD: P = 0.260). A higher cisplatin dose per kilogram LBM in the first course significantly increased the risk of grade 3-4 haematological toxicity (P = 0.011) and neutropenic infections (P = 0.012).
CONCLUSIONS


Patients who received a high dose of cisplatin per kilogram LBM had more haematological toxicity and neutropenic infections than other patients. None of the muscle measures were independent prognostic factors for survival in our cohort of LS SCLC patients who underwent standard chemoradiotherapy.",2020,"There were no significant associations between survival and any of the muscle measures in the univariable analyses (SMI: P = 0.906, SMD: P = 0.829) or in multivariable analyses adjusting for baseline characteristics (SMI: P = 0.836, SMD: P = 0.260).","['Patients from a trial comparing once', 'patients with limited stage small cell lung cancer (LS SCLC', 'Median age was 64\xa0years, 18% had performance status 2, and 38% had stage III', 'patients with limited stage small cell lung cancer']","['TRT', 'cisplatin per kilogram LBM', 'platinum-etoposide chemotherapy and thoracic radiotherapy (TRT', 'cisplatin', 'standard chemoradiotherapy', 'daily hypofractionated with twice daily hyperfractionated TRT']","['skeletal muscle index (SMI), skeletal muscle radiodensity (SMD), and LBM', 'severe toxicity', 'survival', 'survival, and toxicity', 'median overall survival', 'haematological toxicity and neutropenic infections', 'Median LBM', 'Grade 3-4 toxicity', 'risk of grade 3-4 haematological toxicity', 'neutropenic infections']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0278725', 'cui_str': 'Small cell lung cancer limited stage'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0149925', 'cui_str': 'Small cell carcinoma of lung'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}]","[{'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0439209', 'cui_str': 'kg'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}]","[{'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1167779', 'cui_str': 'Neutropenic infection'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",,0.376505,"There were no significant associations between survival and any of the muscle measures in the univariable analyses (SMI: P = 0.906, SMD: P = 0.829) or in multivariable analyses adjusting for baseline characteristics (SMI: P = 0.836, SMD: P = 0.260).","[{'ForeName': 'Tarje Onsøien', 'Initials': 'TO', 'LastName': 'Halvorsen', 'Affiliation': 'Department of Clinical and Molecular Medicine, NTNU, Norwegian University of Science and Technology, Trondheim, 7491, Norway.'}, {'ForeName': 'Christine Damgaard', 'Initials': 'CD', 'LastName': 'Valan', 'Affiliation': 'Department of Clinical and Molecular Medicine, NTNU, Norwegian University of Science and Technology, Trondheim, 7491, Norway.'}, {'ForeName': 'Marit', 'Initials': 'M', 'LastName': 'Slaaen', 'Affiliation': 'Department of Internal Medicine, Innlandet Hospital Trust, Hamar, Norway.'}, {'ForeName': 'Bjørn Henning', 'Initials': 'BH', 'LastName': 'Grønberg', 'Affiliation': 'Department of Clinical and Molecular Medicine, NTNU, Norwegian University of Science and Technology, Trondheim, 7491, Norway.'}]","Journal of cachexia, sarcopenia and muscle",['10.1002/jcsm.12583']
2355,32724912,Does concurrent use of clopidogrel and PPIs increase CV risk in patients with ACS?,"No. Adding a proton pump inhibitor (PPI) in patients taking antiplatelet medications such as clopidogrel for acute coronary syndrome (ACS) doesn't increase the composite risk of cardiovascular (CV) events: CV death, myocardial infarction (MI), and cerebrovascular accident (CVA) (strength of recommendation: B, randomized, controlled trial [RCT] and prepon-derance of posthoc analyses of large RCTs).",2020,"Adding a proton pump inhibitor (PPI) in patients taking antiplatelet medications such as clopidogrel for acute coronary syndrome (ACS) doesn't increase the composite risk of cardiovascular (CV) events: CV death, myocardial infarction (MI), and cerebrovascular accident (CVA) (strength of recommendation: B, randomized, controlled trial [RCT] and prepon-derance of posthoc analyses of large RCTs).","['patients taking antiplatelet medications such as clopidogrel for acute coronary syndrome (ACS', 'patients with ACS']","['proton pump inhibitor (PPI', 'clopidogrel and PPIs']","['CV risk', 'composite risk of cardiovascular (CV) events: CV death, myocardial infarction (MI), and cerebrovascular accident (CVA) (strength of recommendation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}]","[{'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}]","[{'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]",,0.0371785,"Adding a proton pump inhibitor (PPI) in patients taking antiplatelet medications such as clopidogrel for acute coronary syndrome (ACS) doesn't increase the composite risk of cardiovascular (CV) events: CV death, myocardial infarction (MI), and cerebrovascular accident (CVA) (strength of recommendation: B, randomized, controlled trial [RCT] and prepon-derance of posthoc analyses of large RCTs).","[{'ForeName': 'Sandy', 'Initials': 'S', 'LastName': 'Shehata', 'Affiliation': 'Valley Medical Center, Renton, WA, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Baker', 'Affiliation': 'Valley Family Medicine Residency, University of Washington at Valley in Renton, USA.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Kelsberg', 'Affiliation': 'Valley Family Medicine Residency, University of Washington at Valley in Renton, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Safranek', 'Affiliation': 'University of Washington Health Sciences Library, Seattle, USA.'}]",The Journal of family practice,[]
2356,32722941,Intradialytic exercise with blood flow restriction is more effective than conventional exercise in improving walking endurance in hemodialysis patients: comments on a randomized control trial.,,2020,,['hemodialysis patients'],"['conventional exercise', 'Intradialytic exercise with blood flow restriction']",['walking endurance'],"[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}]","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}]",,0.0184829,,"[{'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Clarkson', 'Affiliation': 'Institute of Physical Activity and Nutrition, School of exercise and nutrition sciences, Deakin University, Geelong, Victoria, Australia.'}, {'ForeName': 'Paul N', 'Initials': 'PN', 'LastName': 'Bennett', 'Affiliation': 'Medical & Clinical Affairs, Satellite Healthcare, San Jose, CA, USA.'}, {'ForeName': 'Stuart A', 'Initials': 'SA', 'LastName': 'Warmington', 'Affiliation': 'Institute of Physical Activity and Nutrition, School of exercise and nutrition sciences, Deakin University, Geelong, Victoria, Australia.'}]",Clinical rehabilitation,['10.1177/0269215520945660']
2357,32732022,"Effects of a leaflet on breast cancer screening knowledge, explicit attitudes, and implicit associations.","OBJECTIVE


To assess the effect of an information leaflet on knowledge, explicit attitudes, implicit associations, and attendance for breast cancer screening.
METHODS


Dutch women (aged 49-75 years) were approached three months before their breast cancer screening invitation. After providing informed consent, participants were randomised to receiving the information leaflet (intervention condition) or not (control condition). Screening knowledge, explicit attitudes, and implicit associations were assessed through web-based questionnaires, at baseline and two weeks later. Actual screening attendance data were collected.
RESULTS


In total, 988 women completed both questionnaires. Participants in the leaflet condition scored higher on knowledge (9.9 versus 9.6, p < 0.001, scale 0-11), and more often had positive explicit attitudes (97 % versus 95 %, p = 0.03), than those in the control condition. This contrast was bigger among first-time invitees. Implicit associations were not correlated with explicit attitudes or attendance. Explicit attitudes were moderately correlated with attendance (r=.30, p < 0.001).
CONCLUSION


The information leaflet led to more knowledge and more positive explicit attitudes. Implicit associations towards breast cancer screening were not correlated with attendance.
PRACTICE IMPLICATIONS


Encouragement to learn about the screening programme can increase levels of knowledge of invitees and therefore support their decision-making about participation. This might be especially relevant for first-time invitees.",2020,"Participants in the leaflet condition scored higher on knowledge (9.9 versus 9.6, p < 0.001, scale 0-11), and more often had positive explicit attitudes (97 % versus 95 %, p = 0.03), than those in the control condition.","['988 women completed both questionnaires', 'Dutch women (aged 49-75 years']",['information leaflet (intervention condition) or not (control condition'],"['Explicit attitudes', 'positive explicit attitudes', 'Implicit associations towards breast cancer screening', 'breast cancer screening knowledge, explicit attitudes, and implicit associations', 'knowledge']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0281182', 'cui_str': 'Screening for malignant neoplasm of breast'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",988.0,0.0280732,"Participants in the leaflet condition scored higher on knowledge (9.9 versus 9.6, p < 0.001, scale 0-11), and more often had positive explicit attitudes (97 % versus 95 %, p = 0.03), than those in the control condition.","[{'ForeName': 'Lindy M', 'Initials': 'LM', 'LastName': 'Kregting', 'Affiliation': 'Department of Public Health, Erasmus MC, University Medical Center Rotterdam, the Netherlands. Electronic address: l.kregting@erasmusmc.nl.'}, {'ForeName': 'Nicolien T', 'Initials': 'NT', 'LastName': 'van Ravesteyn', 'Affiliation': 'Department of Public Health, Erasmus MC, University Medical Center Rotterdam, the Netherlands.'}, {'ForeName': 'Wolfert', 'Initials': 'W', 'LastName': 'Spijker', 'Affiliation': 'Bevolkingsonderzoek Zuid-West, Rotterdam, the Netherlands.'}, {'ForeName': 'Tessa', 'Initials': 'T', 'LastName': 'Dierks', 'Affiliation': 'Department of Public Health, Erasmus MC, University Medical Center Rotterdam, the Netherlands.'}, {'ForeName': 'Clare A', 'Initials': 'CA', 'LastName': 'Aitken', 'Affiliation': 'Department of Public Health, Erasmus MC, University Medical Center Rotterdam, the Netherlands.'}, {'ForeName': 'H Amarens', 'Initials': 'HA', 'LastName': 'Geuzinge', 'Affiliation': 'Department of Public Health, Erasmus MC, University Medical Center Rotterdam, the Netherlands.'}, {'ForeName': 'Ida J', 'Initials': 'IJ', 'LastName': 'Korfage', 'Affiliation': 'Department of Public Health, Erasmus MC, University Medical Center Rotterdam, the Netherlands.'}]",Patient education and counseling,['10.1016/j.pec.2020.06.032']
2358,32722925,Intradialytic exercise with blood flow restriction is more effective than conventional exercise in improving walking endurance in hemodialysis patients: Response to comments on a randomized control trial.,,2020,,['hemodialysis patients'],"['conventional exercise', 'Intradialytic exercise with blood flow restriction']",['walking endurance'],"[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}]","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}]",,0.0179709,,"[{'ForeName': 'Maristela', 'Initials': 'M', 'LastName': 'Bohlke', 'Affiliation': 'Dialysis and Renal Transplantation Unit, São Francisco de Paula University Hospital, Catholic University of Pelotas, Pelotas, Brazil.'}, {'ForeName': 'Rodrigo Kohn', 'Initials': 'RK', 'LastName': 'Cardoso', 'Affiliation': 'Postgraduate Program of Physical Education, Federal University of Pelotas, Pelotas, RS, Brazil.'}, {'ForeName': 'Aline Machado', 'Initials': 'AM', 'LastName': 'Araujo', 'Affiliation': 'Postgraduate Program of Physical Education, Federal University of Pelotas, Pelotas, RS, Brazil.'}, {'ForeName': 'Airton José', 'Initials': 'AJ', 'LastName': 'Rombaldi', 'Affiliation': 'Postgraduate Program of Physical Education, Federal University of Pelotas, Pelotas, RS, Brazil.'}]",Clinical rehabilitation,['10.1177/0269215520945659']
2359,32726531,Phase 1 Trial of a Therapeutic Anti-Yellow Fever Virus Human Antibody.,"BACKGROUND


Insufficient vaccine doses and the lack of therapeutic agents for yellow fever put global health at risk, should this virus emerge from sub-Saharan Africa and South America.
METHODS


In phase 1a of this clinical trial, we assessed the safety, side-effect profile, and pharmacokinetics of TY014, a fully human IgG1 anti-yellow fever virus monoclonal antibody. In a double-blind, phase 1b clinical trial, we assessed the efficacy of TY014, as compared with placebo, in abrogating viremia related to the administration of live yellow fever vaccine (YF17D-204; Stamaril). The primary safety outcomes were adverse events reported 1 hour after the infusion and throughout the trial. The primary efficacy outcome was the dose of TY014 at which 100% of the participants tested negative for viremia within 48 hours after infusion.
RESULTS


A total of 27 healthy participants were enrolled in phase 1a, and 10 participants in phase 1b. During phase 1a, TY014 dose escalation to a maximum of 20 mg per kilogram of body weight occurred in 22 participants. During phases 1a and 1b, adverse events within 1 hour after infusion occurred in 1 of 27 participants who received TY014 and in none of the 10 participants who received placebo. At least one adverse event occurred during the trial in 22 participants who received TY014 and in 8 who received placebo. The mean half-life of TY014 was approximately 12.8 days. At 48 hours after the infusion, none of the 5 participants who received the starting dose of TY014 of 2 mg per kilogram had detectable YF17D-204 viremia; these participants remained aviremic throughout the trial. Viremia was observed at 48 hours after the infusion in 2 of 5 participants who received placebo and at 72 hours in 2 more placebo recipients. Symptoms associated with yellow fever vaccine were less frequent in the TY014 group than in the placebo group.
CONCLUSIONS


This phase 1 trial of TY014 did not identify worrisome safety signals and suggested potential clinical benefit, which requires further assessment in a phase 2 trial. (Funded by Tysana; ClinicalTrials.gov number, NCT03776786.).",2020,At least one adverse event occurred during the trial in 22 participants who received TY014 and in 8 who received placebo.,"['27 healthy participants were enrolled in phase 1a, and 10 participants in phase 1b']","['Therapeutic Anti-Yellow Fever Virus Human Antibody', 'placebo']","['Viremia', 'negative for viremia', 'adverse event', 'adverse events', 'detectable YF17D-204 viremia']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0043396', 'cui_str': 'Yellow fever virus'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0042749', 'cui_str': 'Viremia'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",22.0,0.484793,At least one adverse event occurred during the trial in 22 participants who received TY014 and in 8 who received placebo.,"[{'ForeName': 'Jenny G', 'Initials': 'JG', 'LastName': 'Low', 'Affiliation': 'From the Duke-National University of Singapore Medical School (J.G.L., E.Z.O., H.-C.T., E.-E.O.), Singapore General Hospital (J.G.L., S.K., L.W., Y.F.Z.C., D.H.L.N.), Tysana (J.H.J.N., A.B., Y.-H.C., D.C.P.L., Y.B.), and the Singapore-MIT (Massachusetts Institute of Technology) Alliance for Research and Technology (R.S., E.-E.O.) - all in Singapore; and the Massachusetts Institute of Technology, Cambridge (R.S.).'}, {'ForeName': 'Justin H J', 'Initials': 'JHJ', 'LastName': 'Ng', 'Affiliation': 'From the Duke-National University of Singapore Medical School (J.G.L., E.Z.O., H.-C.T., E.-E.O.), Singapore General Hospital (J.G.L., S.K., L.W., Y.F.Z.C., D.H.L.N.), Tysana (J.H.J.N., A.B., Y.-H.C., D.C.P.L., Y.B.), and the Singapore-MIT (Massachusetts Institute of Technology) Alliance for Research and Technology (R.S., E.-E.O.) - all in Singapore; and the Massachusetts Institute of Technology, Cambridge (R.S.).'}, {'ForeName': 'Eugenia Z', 'Initials': 'EZ', 'LastName': 'Ong', 'Affiliation': 'From the Duke-National University of Singapore Medical School (J.G.L., E.Z.O., H.-C.T., E.-E.O.), Singapore General Hospital (J.G.L., S.K., L.W., Y.F.Z.C., D.H.L.N.), Tysana (J.H.J.N., A.B., Y.-H.C., D.C.P.L., Y.B.), and the Singapore-MIT (Massachusetts Institute of Technology) Alliance for Research and Technology (R.S., E.-E.O.) - all in Singapore; and the Massachusetts Institute of Technology, Cambridge (R.S.).'}, {'ForeName': 'Shirin', 'Initials': 'S', 'LastName': 'Kalimuddin', 'Affiliation': 'From the Duke-National University of Singapore Medical School (J.G.L., E.Z.O., H.-C.T., E.-E.O.), Singapore General Hospital (J.G.L., S.K., L.W., Y.F.Z.C., D.H.L.N.), Tysana (J.H.J.N., A.B., Y.-H.C., D.C.P.L., Y.B.), and the Singapore-MIT (Massachusetts Institute of Technology) Alliance for Research and Technology (R.S., E.-E.O.) - all in Singapore; and the Massachusetts Institute of Technology, Cambridge (R.S.).'}, {'ForeName': 'Limin', 'Initials': 'L', 'LastName': 'Wijaya', 'Affiliation': 'From the Duke-National University of Singapore Medical School (J.G.L., E.Z.O., H.-C.T., E.-E.O.), Singapore General Hospital (J.G.L., S.K., L.W., Y.F.Z.C., D.H.L.N.), Tysana (J.H.J.N., A.B., Y.-H.C., D.C.P.L., Y.B.), and the Singapore-MIT (Massachusetts Institute of Technology) Alliance for Research and Technology (R.S., E.-E.O.) - all in Singapore; and the Massachusetts Institute of Technology, Cambridge (R.S.).'}, {'ForeName': 'Yvonne F Z', 'Initials': 'YFZ', 'LastName': 'Chan', 'Affiliation': 'From the Duke-National University of Singapore Medical School (J.G.L., E.Z.O., H.-C.T., E.-E.O.), Singapore General Hospital (J.G.L., S.K., L.W., Y.F.Z.C., D.H.L.N.), Tysana (J.H.J.N., A.B., Y.-H.C., D.C.P.L., Y.B.), and the Singapore-MIT (Massachusetts Institute of Technology) Alliance for Research and Technology (R.S., E.-E.O.) - all in Singapore; and the Massachusetts Institute of Technology, Cambridge (R.S.).'}, {'ForeName': 'Dorothy H L', 'Initials': 'DHL', 'LastName': 'Ng', 'Affiliation': 'From the Duke-National University of Singapore Medical School (J.G.L., E.Z.O., H.-C.T., E.-E.O.), Singapore General Hospital (J.G.L., S.K., L.W., Y.F.Z.C., D.H.L.N.), Tysana (J.H.J.N., A.B., Y.-H.C., D.C.P.L., Y.B.), and the Singapore-MIT (Massachusetts Institute of Technology) Alliance for Research and Technology (R.S., E.-E.O.) - all in Singapore; and the Massachusetts Institute of Technology, Cambridge (R.S.).'}, {'ForeName': 'Hwee-Cheng', 'Initials': 'HC', 'LastName': 'Tan', 'Affiliation': 'From the Duke-National University of Singapore Medical School (J.G.L., E.Z.O., H.-C.T., E.-E.O.), Singapore General Hospital (J.G.L., S.K., L.W., Y.F.Z.C., D.H.L.N.), Tysana (J.H.J.N., A.B., Y.-H.C., D.C.P.L., Y.B.), and the Singapore-MIT (Massachusetts Institute of Technology) Alliance for Research and Technology (R.S., E.-E.O.) - all in Singapore; and the Massachusetts Institute of Technology, Cambridge (R.S.).'}, {'ForeName': 'Anjali', 'Initials': 'A', 'LastName': 'Baglody', 'Affiliation': 'From the Duke-National University of Singapore Medical School (J.G.L., E.Z.O., H.-C.T., E.-E.O.), Singapore General Hospital (J.G.L., S.K., L.W., Y.F.Z.C., D.H.L.N.), Tysana (J.H.J.N., A.B., Y.-H.C., D.C.P.L., Y.B.), and the Singapore-MIT (Massachusetts Institute of Technology) Alliance for Research and Technology (R.S., E.-E.O.) - all in Singapore; and the Massachusetts Institute of Technology, Cambridge (R.S.).'}, {'ForeName': 'Yok-Hian', 'Initials': 'YH', 'LastName': 'Chionh', 'Affiliation': 'From the Duke-National University of Singapore Medical School (J.G.L., E.Z.O., H.-C.T., E.-E.O.), Singapore General Hospital (J.G.L., S.K., L.W., Y.F.Z.C., D.H.L.N.), Tysana (J.H.J.N., A.B., Y.-H.C., D.C.P.L., Y.B.), and the Singapore-MIT (Massachusetts Institute of Technology) Alliance for Research and Technology (R.S., E.-E.O.) - all in Singapore; and the Massachusetts Institute of Technology, Cambridge (R.S.).'}, {'ForeName': 'Debbie C P', 'Initials': 'DCP', 'LastName': 'Lee', 'Affiliation': 'From the Duke-National University of Singapore Medical School (J.G.L., E.Z.O., H.-C.T., E.-E.O.), Singapore General Hospital (J.G.L., S.K., L.W., Y.F.Z.C., D.H.L.N.), Tysana (J.H.J.N., A.B., Y.-H.C., D.C.P.L., Y.B.), and the Singapore-MIT (Massachusetts Institute of Technology) Alliance for Research and Technology (R.S., E.-E.O.) - all in Singapore; and the Massachusetts Institute of Technology, Cambridge (R.S.).'}, {'ForeName': 'Yadunanda', 'Initials': 'Y', 'LastName': 'Budigi', 'Affiliation': 'From the Duke-National University of Singapore Medical School (J.G.L., E.Z.O., H.-C.T., E.-E.O.), Singapore General Hospital (J.G.L., S.K., L.W., Y.F.Z.C., D.H.L.N.), Tysana (J.H.J.N., A.B., Y.-H.C., D.C.P.L., Y.B.), and the Singapore-MIT (Massachusetts Institute of Technology) Alliance for Research and Technology (R.S., E.-E.O.) - all in Singapore; and the Massachusetts Institute of Technology, Cambridge (R.S.).'}, {'ForeName': 'Ram', 'Initials': 'R', 'LastName': 'Sasisekharan', 'Affiliation': 'From the Duke-National University of Singapore Medical School (J.G.L., E.Z.O., H.-C.T., E.-E.O.), Singapore General Hospital (J.G.L., S.K., L.W., Y.F.Z.C., D.H.L.N.), Tysana (J.H.J.N., A.B., Y.-H.C., D.C.P.L., Y.B.), and the Singapore-MIT (Massachusetts Institute of Technology) Alliance for Research and Technology (R.S., E.-E.O.) - all in Singapore; and the Massachusetts Institute of Technology, Cambridge (R.S.).'}, {'ForeName': 'Eng-Eong', 'Initials': 'EE', 'LastName': 'Ooi', 'Affiliation': 'From the Duke-National University of Singapore Medical School (J.G.L., E.Z.O., H.-C.T., E.-E.O.), Singapore General Hospital (J.G.L., S.K., L.W., Y.F.Z.C., D.H.L.N.), Tysana (J.H.J.N., A.B., Y.-H.C., D.C.P.L., Y.B.), and the Singapore-MIT (Massachusetts Institute of Technology) Alliance for Research and Technology (R.S., E.-E.O.) - all in Singapore; and the Massachusetts Institute of Technology, Cambridge (R.S.).'}]",The New England journal of medicine,['10.1056/NEJMoa2000226']
2360,32736216,Combined exercise training improves cognitive functions in multiple sclerosis patients with cognitive impairment: A single-blinded randomized controlled trial.,"BACKGROUND


Cognitive impairment is common in patients with multiple sclerosis (MS). The effects of different exercise trainings on cognitive functions in patients with MS are promising. However, the effects are not yet clear in MS patients with cognitive impairment. This study aimed to investigate the effect of combined exercise training on different cognitive functions in MS patients with cognitive impairment.
METHODS


Relapsing-remitting and mild disabled MS patients with cognitive impairment were randomly assigned to two groups: Exercise Group (EG, n:17) and the Control Group (CG, n:17). The EG received a combined exercise training consisting of aerobic and Pilates training in three sessions per week for 8 weeks while the CG performed the relaxation exercises at home. Cognitive functions, walking capacity, fatigue, mood, and quality of life were assessed at baseline and after eight weeks using the Brief Repeatable Battery of Neuropsychological Tests (BRB-N), Six-Minute Walk Test (6-MWT), Fatigue Impact Scale (FIS), Beck's Depression Inventory (BDI) and MS Quality of Life-54 (MSQoL-54), respectively.
RESULTS


This study showed significant group-by-time interactions on long-term verbal memory, walking capacity, cognitive fatigue, and physical quality of life in favor of the EG (p<0.003). Moreover, verbal memory, visuospatial memory, verbal fluency, information processing speed, walking capacity, fatigue, and quality of life improved in the EG (p<0.05) while only verbal memory increased in the CG (p<0.05). Furthermore, the change in visuospatial memory was associated with the change in mental quality of life (r:0.352, p: 0.041) while the change in verbal fluency (r: -0.362, p:0.035) and processing speed (r: -0.356, p:0.039) were associated with the change in mood.
CONCLUSION


Combined exercise training has beneficial effects on different cognitive functions in mild disabled RRMS patients with cognitive impairment. In addition, there is a mutual relationship in improvements in cognitive functions, mood, and quality of life after exercise.",2020,"This study showed significant group-by-time interactions on long-term verbal memory, walking capacity, cognitive fatigue, and physical quality of life in favor of the EG (p<0.003).","['mild disabled RRMS patients with cognitive impairment', 'multiple sclerosis patients with cognitive impairment', 'patients with MS', 'Relapsing-remitting and mild disabled MS patients with cognitive impairment', 'patients with multiple sclerosis (MS', 'MS patients with cognitive impairment']","['Combined exercise training', 'combined exercise training consisting of aerobic and Pilates training', 'exercise trainings', 'Exercise Group (EG, n:17) and the Control Group (CG, n:17', 'combined exercise training']","['change in visuospatial memory', 'verbal fluency', 'long-term verbal memory, walking capacity, cognitive fatigue, and physical quality of life', 'processing speed', 'Cognitive functions, walking capacity, fatigue, mood, and quality of life', 'cognitive functions', ""Brief Repeatable Battery of Neuropsychological Tests (BRB-N), Six-Minute Walk Test (6-MWT), Fatigue Impact Scale (FIS), Beck's Depression Inventory (BDI) and MS Quality of Life-54 (MSQoL-54), respectively"", 'verbal memory, visuospatial memory, verbal fluency, information processing speed, walking capacity, fatigue, and quality of life improved in the EG (p<0.05) while only verbal memory', 'mental quality of life', 'cognitive functions, mood, and quality of life']","[{'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0018576', 'cui_str': 'Handicapped'}, {'cui': 'C1522002', 'cui_str': 'RRM Motif'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C2733557', 'cui_str': 'Fatigue impact scale'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0021420', 'cui_str': 'Information Processing'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",,0.0502248,"This study showed significant group-by-time interactions on long-term verbal memory, walking capacity, cognitive fatigue, and physical quality of life in favor of the EG (p<0.003).","[{'ForeName': 'Cagla', 'Initials': 'C', 'LastName': 'Ozkul', 'Affiliation': 'Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Ankara, Turkey. Electronic address: caglaozkul@hotmail.com.'}, {'ForeName': 'Arzu', 'Initials': 'A', 'LastName': 'Guclu-Gunduz', 'Affiliation': 'Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Ankara, Turkey.'}, {'ForeName': 'Kader', 'Initials': 'K', 'LastName': 'Eldemir', 'Affiliation': 'Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Ankara, Turkey.'}, {'ForeName': 'Yasemin', 'Initials': 'Y', 'LastName': 'Apaydin', 'Affiliation': 'Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Ankara, Turkey.'}, {'ForeName': 'Gokhan', 'Initials': 'G', 'LastName': 'Yazici', 'Affiliation': 'Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Ankara, Turkey.'}, {'ForeName': 'Ceyla', 'Initials': 'C', 'LastName': 'Irkec', 'Affiliation': 'Gazi University, Faculty of Medicine, Department of Neurology, Ankara, Turkey.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2020.102419']
2361,32736299,"A beverage containing ora-pro-nobis flour improves intestinal health, weight, and body composition: A double-blind randomized prospective study.","OBJECTIVE


The aim of this study was to verify the effect of a beverage containing ora-pro-nobis (OPN) flour on intestinal microbiota, gastrointestinal symptoms, and anthropometric parameters in women.
METHODS


This prospective, double-blinded, randomized clinical trial included 24 women volunteers. For 6 wk, the test group received a beverage supplemented with OPN, and the control group received the same beverage without OPN. Fecal microbiota were evaluated by the fluorescence in situ hybridization method. Each participant responded to a questionnaire based on the Gastrointestinal Symptom Rating Scale. The data were analyzed by Student's t test to compare the effects between treatments (P < 0.05).
RESULTS


Supplementation with the OPN beverage reduced weight (P = 0.008), waist circumference (P = 0.010), and body fat (P = 0.000). Additionally, the treatment increased satiety (P = 0.039), reduced eructation (P = 0.038) and constipation (P = 0.017), and improved feces consistency (P = 0.017).
CONCLUSION


The OPN flour beverage has an effect on weight reduction, body fat composition, and improvement in gastrointestinal symptoms. These results highlight the beneficial effects of ora-pro-nobis flour beverage against the development of obesity.",2020,"RESULTS


Supplementation with the OPN beverage reduced weight (P = 0.008), waist circumference (P = 0.010), and body fat (P = 0.000).","['24 women volunteers', 'women']","['beverage containing ora-pro-nobis (OPN) flour', 'beverage supplemented with OPN, and the control group received the same beverage without OPN']","['weight', 'waist circumference', 'feces consistency', 'satiety', 'Gastrointestinal Symptom Rating Scale', 'intestinal health, weight, and body composition', 'weight reduction, body fat composition, and improvement in gastrointestinal symptoms', 'reduced eructation', 'Fecal microbiota', 'intestinal microbiota, gastrointestinal symptoms, and anthropometric parameters', 'body fat', 'constipation']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0016260', 'cui_str': 'Flour'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0036239', 'cui_str': 'Satiety'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0014724', 'cui_str': 'Eructation'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}]",24.0,0.165472,"RESULTS


Supplementation with the OPN beverage reduced weight (P = 0.008), waist circumference (P = 0.010), and body fat (P = 0.000).","[{'ForeName': 'Camilla Ribeiro', 'Initials': 'CR', 'LastName': 'Vieira', 'Affiliation': 'Department of Nutrition, Universidade Federal de Alfenas, Alfenas, Brazil.'}, {'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Grancieri', 'Affiliation': 'Department of Nutrition and Health, Universidade Federal de Viçosa, Viçosa, Brazil.'}, {'ForeName': 'Hércia Stampini Duarte', 'Initials': 'HSD', 'LastName': 'Martino', 'Affiliation': 'Department of Nutrition and Health, Universidade Federal de Viçosa, Viçosa, Brazil.'}, {'ForeName': 'Dionéia Evangelista', 'Initials': 'DE', 'LastName': 'César', 'Affiliation': 'Department of Biology, Universidade Federal de Juiz de Fora, Juiz de Fora, Brazil.'}, {'ForeName': 'Roberta Ribeiro Silva', 'Initials': 'RRS', 'LastName': 'Barra', 'Affiliation': 'Department of Nutrition, Universidade Federal de Alfenas, Alfenas, Brazil. Electronic address: betaribeiro@hotmail.com.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2020.110869']
2362,32738130,"Influence of concurrent capecitabine based chemoradiotherapy with bevacizumab on the survival rate, late toxicity and health-related quality of life in locally advanced rectal cancer: a prospective phase II CRAB trial.","Background Few studies reported early results on efficacy, toxicity of combined modality treatment for locally advanced rectal cancer (LARC) by adding bevacizumab to preoperative chemoradiotherapy, but long-term data on survival, and late complications are lacking. Further, none of the studies reported on the assessment of quality of life (QOL). Patients and methods After more than 5 years of follow-up, we updated the results of our previous phase II trial in 61 patients with LARC treated with neoadjuvant capecitabine, radiotherapy and bevacizumab (CRAB study) before surgery and adjuvant chemotherapy. Secondary endpoints of updated analysis were local control (LC), disease free (DFS) and overall survival (OS), late toxicity and longitudinal health related QOL (before starting the treatment and one year after the treatment) with questionnaire EORTC QLQ-C30 and EORTC QLQ-CR38. Results Median follow-up was 67 months. During the follow-up period, 16 patients (26.7%) died. The 5-year OS, DFS and LC rate were 72.2%, 70% and 92.4%. Patients with pathological positive nodes or pathological T3-4 tumors had significantly worse survival than patients with pathological negative nodes or T0-2 tumors. Nine patients (14.8%) developed grade 33 late complications of combined modality treatment, first event 12 months and last 87 months after operation (median time 48 months). Based on EORTC QLQ-C30 scores one year after treatment there were no significant changes in global QOL and three symptoms (pain, insomnia and diarrhea), but physical and social functioning significantly decreased. Based on QLQ-CR38 scores body image scores significantly increase, problems with weight loss significantly decrease, but sexual dysfunction in men and chemotherapy side effects significantly increase. Conclusions Patients with LARC and high risk factors, such as positive pathological lymph nodes and high pathological T stage, deserve more aggressive treatment in the light of improving long-term survival results. Patients after multimodality treatment should be given greater attention to the regulation of individual aspects of quality of life and the occurrence of late side effects.",2020,"Based on EORTC QLQ-C30 scores one year after treatment there were no significant changes in global QOL and three symptoms (pain, insomnia and diarrhea), but physical and social functioning significantly decreased.","['61 patients with LARC treated with', 'locally advanced rectal cancer (LARC', 'locally advanced rectal cancer', 'Patients with pathological positive nodes or pathological T3-4 tumors']","['neoadjuvant capecitabine, radiotherapy and bevacizumab (CRAB study) before surgery and adjuvant chemotherapy', 'capecitabine based chemoradiotherapy with bevacizumab', 'bevacizumab']","['5-year OS, DFS and LC rate', 'grade 33 late complications', 'local control (LC), disease free (DFS) and overall survival (OS), late toxicity and longitudinal health related QOL', 'questionnaire EORTC QLQ-C30 and EORTC QLQ-CR38', 'survival', 'physical and social functioning', 'quality of life (QOL', 'efficacy, toxicity', 'QLQ-CR38 scores body image scores', 'sexual dysfunction', 'global QOL and three symptoms (pain, insomnia and diarrhea', 'survival rate, late toxicity and health-related quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}]","[{'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0010260', 'cui_str': 'Infraorder Brachyura'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005891', 'cui_str': 'Body image'}, {'cui': 'C0549622', 'cui_str': 'Sexual disorder'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",61.0,0.0636662,"Based on EORTC QLQ-C30 scores one year after treatment there were no significant changes in global QOL and three symptoms (pain, insomnia and diarrhea), but physical and social functioning significantly decreased.","[{'ForeName': 'Vaneja', 'Initials': 'V', 'LastName': 'Velenik', 'Affiliation': 'Division of Radiotherapy, Institute of Oncology, Ljubljana, Slovenia.'}, {'ForeName': 'Vesna', 'Initials': 'V', 'LastName': 'Zadnik', 'Affiliation': 'Division of Epidemiology, Institute of Oncology, Ljubljana, Slovenia.'}, {'ForeName': 'Mirko', 'Initials': 'M', 'LastName': 'Omejc', 'Affiliation': 'Division of Surgery, University Medical Center Ljubljana, Ljubljana, Slovenia.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Grosek', 'Affiliation': 'Division of Surgery, University Medical Center Ljubljana, Ljubljana, Slovenia.'}, {'ForeName': 'Mojca', 'Initials': 'M', 'LastName': 'Tuta', 'Affiliation': 'Division of Radiology, Institute of Oncology, Ljubljana, Slovenia.'}]",Radiology and oncology,['10.2478/raon-2020-0043']
2363,32724156,A comparison of the effectiveness of azelaic and pyruvic acid peels in the treatment of female adult acne: a randomized controlled trial.,"Chemical peels are widely used as therapeutic agents in dermatology and cosmetology. This study aims to explore the differences in the effectiveness of azelaic and pyruvic acid peels in the treatment of acne vulgaris. Eligibility criteria for participants were: female gender, 18-25 years of age, no dermatological treatment within the last 12 months and mild to moderate papulopustular acne. We treated 120 young women (with a mean age of 22 years old) with six peeling sessions at 2-week intervals. In the parallel clinical study design, one randomized group (n = 60, 50%) was treated using azelaic acid (AA), whereas the second group participated in pyruvic acid (PA) sessions. We evaluated the patients clinically twice (before and after treatment), using the Scale of Hellegren-Vincent Severity Symptoms to assess the acne diagnosis, and the Nati Analyzer to estimate the skin properties (oily skin, desquamation, porosity, and moisture). The clinical evaluation of the patients demonstrated a significant reduction of acne severity symptoms in both the AA and PA groups, after the peeling sessions. An effect was also found in terms of decreasing desquamation and the oiliness of the skin. PA showed a more significant reduction of greasy skin than AA. In conclusion, after the six peeling sessions using AA and PA, all patients showed better skin parameters in term of reduced oiliness and desquamation. Both AA and PA peelings are a safe and efficient treatment for mild acne, however, during the selection of one of the two acids, side effects, skin properties, and patients' preferences should be taken into account. This study was registered in the ISRCTN registry (registration number ISRCTN79716614, 17/01/2020).",2020,"The clinical evaluation of the patients demonstrated a significant reduction of acne severity symptoms in both the AA and PA groups, after the peeling sessions.","['Eligibility criteria for participants were: female gender, 18-25\xa0years of age, no dermatological treatment within the last 12\xa0months and mild to moderate papulopustular acne', 'female adult acne', '120 young women (with a mean age of 22\xa0years old) with six peeling sessions at 2-week intervals', 'acne vulgaris']","['azelaic acid (AA), whereas the second group participated in pyruvic acid (PA) sessions', 'azelaic and pyruvic acid peels']","['skin properties (oily skin, desquamation, porosity, and moisture', 'skin parameters', 'acne severity symptoms']","[{'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0086287', 'cui_str': 'Female'}, {'cui': 'C0450335', 'cui_str': '18/25'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0011625', 'cui_str': 'DERMATOLOGICALS'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0001144', 'cui_str': 'Acne vulgaris'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1858506', 'cui_str': 'Acne, Adult'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0237849', 'cui_str': 'Peeling of skin'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1272706', 'cui_str': 'Interval'}]","[{'cui': 'C0052761', 'cui_str': 'azelaic acid'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0072802', 'cui_str': 'Pyruvic acid'}, {'cui': 'C0237849', 'cui_str': 'Peeling of skin'}]","[{'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0871161', 'cui_str': 'Property'}, {'cui': 'C0234925', 'cui_str': 'Greasy skin'}, {'cui': 'C0237849', 'cui_str': 'Peeling of skin'}, {'cui': 'C0080037', 'cui_str': 'Porosity'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0001144', 'cui_str': 'Acne vulgaris'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}]",120.0,0.0240227,"The clinical evaluation of the patients demonstrated a significant reduction of acne severity symptoms in both the AA and PA groups, after the peeling sessions.","[{'ForeName': 'Karolina', 'Initials': 'K', 'LastName': 'Chilicka', 'Affiliation': 'Faculty of Health Sciences, University of Opole, 45-060, Opole, Poland.'}, {'ForeName': 'Aleksandra M', 'Initials': 'AM', 'LastName': 'Rogowska', 'Affiliation': 'Institute of Psychology, University of Opole, 45-052, Opole, Poland. arogowska@uni.opole.pl.'}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Szyguła', 'Affiliation': 'Faculty of Health Sciences, University of Opole, 45-060, Opole, Poland.'}, {'ForeName': 'Iwona', 'Initials': 'I', 'LastName': 'Dzieńdziora-Urbińska', 'Affiliation': 'Faculty of Health Sciences, University of Opole, 45-060, Opole, Poland.'}, {'ForeName': 'Jakub', 'Initials': 'J', 'LastName': 'Taradaj', 'Affiliation': 'Institute of Physiotherapy and Health Sciences, Academy of Physical Education, 40-065, Katowice, Poland.'}]",Scientific reports,['10.1038/s41598-020-69530-w']
2364,32730948,An Integrative Clustering Approach to tDCS Individual Response Variability in Cognitive Performance: Beyond a Null Effect on Working Memory.,"Despite the growing interest in the use of transcranial direct current stimulation (tDCS) for the modulation of human cognitive function, there are contradictory findings regarding the cognitive benefits of this technique. Inter-individual response variability to tDCS may play a significant role. We explored the effects of anodal versus sham tDCS over the left prefrontal cortex (LPFC) on working memory performance, taking into account the inter-individual variability. Twenty-nine healthy volunteers received an 'offline' anodal tDCS (1.5 mA, 15 min) to the left prefrontal cortex (F3 electrode site) in an intra-individual, cross-over, sham-controlled experimental design. n-back and Sternberg task performance was assessed before (baseline), immediately after tDCS administration (T1) and 5 min post-T1 (T2). We applied an integrative clustering approach to characterize both the group and individual responses to tDCS, as well as identifying naturally occurring subgroups that may be present within the total sample. Anodal tDCS failed to improve working memory performance in the total sample. Cluster analysis identified a subgroup of 'responders' who significantly improved their performance after anodal (vs. sham) stimulation, although not to a greater extent than the best baseline or sham condition. The proportion of 'responders' ranged from 15% to 59% across task conditions and behavioral outputs. Our findings show a high inter-individual variability of the tDCS response, suggesting that the use of tCDS may not be an effective tool to improve working memory performance in healthy subjects. We propose that the use of clustering methods is more suitable in identifying 'responders' and for evaluating the efficacy of this technique.",2020,"Cluster analysis identified a subgroup of 'responders' who significantly improved their performance after anodal (vs. sham) stimulation, although not to a greater extent than the best baseline or sham condition.","['Twenty-nine healthy volunteers', 'healthy subjects']","['Anodal tDCS', 'transcranial direct current stimulation (tDCS', 'anodal versus sham tDCS', ""offline' anodal tDCS (1.5mA, 15min) to the left prefrontal cortex (F3 electrode site) in an intra-individual, cross-over, sham-controlled experimental design""]","['n-back and Sternberg task performance', 'working memory performance']","[{'cui': 'C0450351', 'cui_str': '29'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0450424', 'cui_str': 'To the left'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0013812', 'cui_str': 'Electrode'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0010366', 'cui_str': 'Genetic crossing over'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}]","[{'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}]",29.0,0.0384338,"Cluster analysis identified a subgroup of 'responders' who significantly improved their performance after anodal (vs. sham) stimulation, although not to a greater extent than the best baseline or sham condition.","[{'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Luque-Casado', 'Affiliation': 'Area of Sport Sciences, Faculty of Sports Sciences and Physical Education, Center for Sport Studies, King Juan Carlos University, Madrid, Spain.'}, {'ForeName': 'Rocío', 'Initials': 'R', 'LastName': 'Rodríguez-Freiría', 'Affiliation': 'Department of Physical Education and Sport, Faculty of Sports Sciences and Physical Education, University of A Coruna, Performance and Health Group, A Coruña, Spain.'}, {'ForeName': 'Noa', 'Initials': 'N', 'LastName': 'Fogelson', 'Affiliation': 'Area of Sport Sciences, Faculty of Sports Sciences and Physical Education, Center for Sport Studies, King Juan Carlos University, Madrid, Spain.'}, {'ForeName': 'Eliseo', 'Initials': 'E', 'LastName': 'Iglesias-Soler', 'Affiliation': 'Department of Physical Education and Sport, Faculty of Sports Sciences and Physical Education, University of A Coruna, Performance and Health Group, A Coruña, Spain.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Fernández-Del-Olmo', 'Affiliation': 'Area of Sport Sciences, Faculty of Sports Sciences and Physical Education, Center for Sport Studies, King Juan Carlos University, Madrid, Spain. Electronic address: miguel.delolmo@urjc.es.'}]",Neuroscience,['10.1016/j.neuroscience.2020.07.036']
2365,32738409,Acute effects of adaptive Deep Brain Stimulation in Parkinson's disease.,"BACKGROUND


Beta-based adaptive Deep Brain Stimulation (aDBS) is effective in Parkinson's disease (PD), when assessed in the immediate post-implantation phase. However, the potential benefits of aDBS in patients with electrodes chronically implanted, in whom changes due to the microlesion effect have disappeared, are yet to be assessed.
METHODS


To determine the acute effectiveness and side-effect profile of aDBS in PD compared to conventional continuous DBS (cDBS) and no stimulation (NoStim), years after DBS implantation, 13 PD patients undergoing battery replacement were pseudo-randomised in a crossover fashion, into three conditions (NoStim, aDBS or cDBS), with a 2-min interval between them. Patient videos were blindly evaluated using a short version of the Unified Parkinson's Disease Rating Scale (subUPDRS), and the Speech Intelligibility Test (SIT).
RESULTS


Mean disease duration was 16 years, and the mean time since DBS-implantation was 6.9 years. subUPDRS scores (11 patients tested) were significantly lower both in aDBS (p=<.001), and cDBS (p = .001), when compared to NoStim. Bradykinesia subscores were significantly lower in aDBS (p = .002), and did not achieve significance during cDBS (p = .08), when compared to NoStim. Two patients demonstrated re-emerging tremor during aDBS. SIT scores of patients who presented stimulation-induced dysarthria significantly worsened in cDBS (p = .009), but not in aDBS (p = .407), when compared to NoStim. Overall, stimulation was applied 48.8% of the time during aDBS.
CONCLUSION


Beta-based aDBS is effective in PD patients with bradykinetic phenotypes, delivers less stimulation than cDBS, and potentially has a more favourable speech side-effect profile. Patients with prominent tremor may require a modified adaptive strategy.",2020,"subUPDRS scores (11 patients tested) were significantly lower both in aDBS (p=<.001), and cDBS (p=.001), when compared to NoStim.","[""Parkinson's disease"", 'PD patients with bradykinetic phenotypes', '13 PD patients undergoing battery replacement', 'Patients with prominent tremor', ""Parkinson's disease (PD""]","['aDBS', 'Adaptive Deep Brain Stimulation', 'Beta-based aDBS', 'Beta-based adaptive Deep Brain Stimulation (aDBS', 'conventional continuous DBS (cDBS) and no stimulation (NoStim), years after DBS implantation']","['Mean disease duration', 'subUPDRS scores', 'SIT scores', ""Unified Parkinson's Disease Rating Scale (subUPDRS), and the Speech Intelligibility Test (SIT"", 'mean time since DBS-implantation', 'Bradykinesia subscores']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031437', 'cui_str': 'Phenotype'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0205402', 'cui_str': 'Prominent'}, {'cui': 'C0040822', 'cui_str': 'Tremor'}]","[{'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0445093', 'cui_str': 'No stimulation'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037824', 'cui_str': 'Speech Intelligibility'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0233565', 'cui_str': 'Bradykinesia'}]",,0.0348207,"subUPDRS scores (11 patients tested) were significantly lower both in aDBS (p=<.001), and cDBS (p=.001), when compared to NoStim.","[{'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Piña-Fuentes', 'Affiliation': 'Department of Neurosurgery, University Medical Centre Groningen, the Netherlands; Medical Research Council Brain Network Dynamics Unit at the University of Oxford, United Kingdom; Nuffield Department of Clinical Neurosciences, University of Oxford, United Kingdom; Department of Neurology, Amsterdam Neuroscience Institute, Amsterdam University Medical Center, Amsterdam, The Netherlans.'}, {'ForeName': 'J Marc C', 'Initials': 'JMC', 'LastName': 'van Dijk', 'Affiliation': 'Department of Neurosurgery, University Medical Centre Groningen, the Netherlands.'}, {'ForeName': 'Jonathan C', 'Initials': 'JC', 'LastName': 'van Zijl', 'Affiliation': 'Department of Neurology, Amsterdam Neuroscience Institute, Amsterdam University Medical Center, Amsterdam, The Netherlans.'}, {'ForeName': 'Harmen R', 'Initials': 'HR', 'LastName': 'Moes', 'Affiliation': 'Department of Neurology, Amsterdam Neuroscience Institute, Amsterdam University Medical Center, Amsterdam, The Netherlans.'}, {'ForeName': 'Teus', 'Initials': 'T', 'LastName': 'van Laar', 'Affiliation': 'Department of Neurology, Amsterdam Neuroscience Institute, Amsterdam University Medical Center, Amsterdam, The Netherlans.'}, {'ForeName': 'D L Marinus', 'Initials': 'DLM', 'LastName': 'Oterdoom', 'Affiliation': 'Department of Neurosurgery, University Medical Centre Groningen, the Netherlands.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Little', 'Affiliation': 'Department of Movement Disorders and Neuromodulation, University of California San Francisco, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Brown', 'Affiliation': 'Medical Research Council Brain Network Dynamics Unit at the University of Oxford, United Kingdom; Nuffield Department of Clinical Neurosciences, University of Oxford, United Kingdom.'}, {'ForeName': 'Martijn', 'Initials': 'M', 'LastName': 'Beudel', 'Affiliation': 'Department of Neurology, Amsterdam Neuroscience Institute, Amsterdam University Medical Center, Amsterdam, The Netherlans. Electronic address: m.beudel@amsterdamumc.nl.'}]",Brain stimulation,['10.1016/j.brs.2020.07.016']
2366,32728820,Exercise training improves vascular function in patients with Alzheimer's disease.,"PURPOSE


Vascular dysfunction has been demonstrated in patients with Alzheimer's disease (AD). Exercise is known to positively affect vascular function. Thus, the aim of our study was to investigate exercise-induced effects on vascular function in AD.
METHODS


Thirty-nine patients with AD (79 ± 8 years) were recruited and randomly assigned to exercise training (EX, n = 20) or control group (CTRL, n = 19). All subjects performed 72 treatment sessions (90 min, 3 t/w). EX included moderate-high-intensity aerobic and strength training. CTRL included cognitive stimuli (visual, verbal, auditive). Before and after the 6-month treatment, the vascular function was measured by passive-leg movement test (PLM, calculating the variation in blood flow: ∆peak; and area under the curve: AUC) tests, and flow-mediated dilation (FMD, %). A blood sample was analyzed for vascular endothelial growth factor (VEGF). Arterial blood flow (BF) and shear rate (SR) were measured during EX and CTRL during a typical treatment session.
RESULTS


EX group has increased FMD% (+ 3.725%, p < 0.001), PLM ∆peak (+ 99.056 ml/min, p = 0.004), AUC (+ 37.359AU, p = 0.037) and VEGF (+ 8.825 pg/ml, p = 0.004). In the CTRL group, no difference between pre- and post-treatment was found for any variable. Increase in BF and SR was demonstrated during EX (BF + 123%, p < 0.05; SR + 134%, p < 0.05), but not during CTRL treatment.
CONCLUSION


Exercise training improves peripheral vascular function in AD. These ameliorations may be due to the repetitive increase in SR during exercise which triggers NO and VEGF upregulation. This approach might be included in standard AD clinical practice as an effective strategy to treat vascular dysfunction in this population.",2020,"RESULTS


EX group has increased FMD% (+ 3.725%, p < 0.001), PLM ∆peak (+ ","[""patients with Alzheimer's disease"", ""patients with Alzheimer's disease (AD"", 'Thirty-nine patients with AD (79\u2009±\u20098\xa0years']","['exercise training (EX, n\u2009=\u200920) or control group (CTRL', 'Exercise training']","['Arterial blood flow (BF) and shear rate (SR', 'CTRL included cognitive stimuli (visual, verbal, auditive', 'vascular endothelial growth factor (VEGF', 'passive-leg movement\xa0test (PLM, calculating the variation in blood flow: ∆peak; and area under the curve: AUC) tests, and flow-mediated dilation (FMD, ', 'FMD', 'PLM ∆peak ', 'moderate-high-intensity aerobic and strength training', 'peripheral vascular function', 'vascular function', 'BF and SR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C3816447', 'cui_str': '39'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0229665', 'cui_str': 'Arterial blood'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0175735', 'cui_str': 'Scissors'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0016052', 'cui_str': 'Fibromuscular dysplasia'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}]",39.0,0.064598,"RESULTS


EX group has increased FMD% (+ 3.725%, p < 0.001), PLM ∆peak (+ ","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Pedrinolla', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Via Casorati 43, 37131, Verona, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Venturelli', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Via Casorati 43, 37131, Verona, Italy. massimo.venturelli@univr.it.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Fonte', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Via Casorati 43, 37131, Verona, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Tamburin', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Via Casorati 43, 37131, Verona, Italy.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Di Baldassarre', 'Affiliation': ""Department of Medicine and Aging Sciences, University G. D'Annunzio, Chieti-Pescara, Chieti, Italy.""}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Naro', 'Affiliation': 'Department of Anatomical, Histological, Forensic Medicine and Orthopedic Science, Rome, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Varalta', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Via Casorati 43, 37131, Verona, Italy.'}, {'ForeName': 'Gaia', 'Initials': 'G', 'LastName': 'Giuriato', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Via Casorati 43, 37131, Verona, Italy.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Ghinassi', 'Affiliation': ""Department of Medicine and Aging Sciences, University G. D'Annunzio, Chieti-Pescara, Chieti, Italy.""}, {'ForeName': 'Ettore', 'Initials': 'E', 'LastName': 'Muti', 'Affiliation': 'Mons. A. Mazzali Foundation, Mantua, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Smania', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Via Casorati 43, 37131, Verona, Italy.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Schena', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Via Casorati 43, 37131, Verona, Italy.'}]",European journal of applied physiology,['10.1007/s00421-020-04447-w']
2367,32726528,Single-Dose Nirsevimab for Prevention of RSV in Preterm Infants.,"BACKGROUND


Respiratory syncytial virus (RSV) is the most common cause of lower respiratory tract infection in infants, and a need exists for prevention of RSV in healthy infants. Nirsevimab is a monoclonal antibody with an extended half-life that is being developed to protect infants for an entire RSV season with a single intramuscular dose.
METHODS


In this trial conducted in both northern and southern hemispheres, we evaluated nirsevimab for the prevention of RSV-associated lower respiratory tract infection in healthy infants who had been born preterm (29 weeks 0 days to 34 weeks 6 days of gestation). We randomly assigned the infants in a 2:1 ratio to receive nirsevimab, at a dose of 50 mg in a single intramuscular injection, or placebo at the start of an RSV season. The primary end point was medically attended RSV-associated lower respiratory tract infection through 150 days after administration of the dose. The secondary efficacy end point was hospitalization for RSV-associated lower respiratory tract infection through 150 days after administration of the dose.
RESULTS


From November 2016 through November 2017, a total of 1453 infants were randomly assigned to receive nirsevimab (969 infants) or placebo (484 infants) at the start of the RSV season. The incidence of medically attended RSV-associated lower respiratory tract infection was 70.1% lower (95% confidence interval [CI], 52.3 to 81.2) with nirsevimab prophylaxis than with placebo (2.6% [25 infants] vs. 9.5% [46 infants]; P<0.001) and the incidence of hospitalization for RSV-associated lower respiratory tract infection was 78.4% lower (95% CI, 51.9 to 90.3) with nirsevimab than with placebo (0.8% [8 infants] vs. 4.1% [20 infants]; P<0.001). These differences were consistent throughout the 150-day period after the dose was administered and across geographic locations and RSV subtypes. Adverse events were similar in the two trial groups, with no notable hypersensitivity reactions.
CONCLUSIONS


A single injection of nirsevimab resulted in fewer medically attended RSV-associated lower respiratory tract infections and hospitalizations than placebo throughout the RSV season in healthy preterm infants. (Funded by AstraZeneca and Sanofi Pasteur; ClinicalTrials.gov number, NCT02878330.).",2020,A single injection of nirsevimab resulted in fewer medically attended RSV-associated lower respiratory tract infections and hospitalizations than placebo throughout the RSV season in healthy preterm infants.,"['healthy infants who had been born preterm (29 weeks 0 days to 34 weeks 6 days of gestation', 'Preterm Infants', 'northern and southern hemispheres', '969 infants) or', 'healthy preterm infants', 'From November 2016 through November 2017, a total of 1453 infants', 'healthy infants']","['placebo', 'nirsevimab']","['Adverse events', 'incidence of medically attended RSV-associated lower respiratory tract infection', 'medically attended RSV-associated lower respiratory tract infection', 'incidence of hospitalization for RSV-associated lower respiratory tract infection', 'hospitalization for RSV-associated lower respiratory tract infection']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0035236', 'cui_str': 'Syncytial Virus, Respiratory'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0149725', 'cui_str': 'Lower respiratory tract infection'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",1453.0,0.503207,A single injection of nirsevimab resulted in fewer medically attended RSV-associated lower respiratory tract infections and hospitalizations than placebo throughout the RSV season in healthy preterm infants.,"[{'ForeName': 'M Pamela', 'Initials': 'MP', 'LastName': 'Griffin', 'Affiliation': ""From AstraZeneca, Gaithersburg, MD (M.P.G., Y.Y., T.T., M.T.E., A.A.K., F.D., T.V.); SUNY Upstate Medical University, Syracuse, NY (J.B.D.); Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, and Department of Science and Technology/National Research Foundation South African Research Chair, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (S.A.M.); the Division of Pediatrics and Neonatology, Department of Maternal, Neonatal, and Infant Medicine, Nuovo Ospedale Degli Infermi, Biella, and Neonatology and NICU, Sant'Anna Hospital, AOU Città della Salute e della Scienza, Turin - both in Italy (P.M.); the University of Colorado School of Medicine, Aurora (E.A.F.S.); and the Children's Foundation Research Institute at Le Bonheur Children's Hospital, Memphis, TN (J.P.D.V.).""}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Yuan', 'Affiliation': ""From AstraZeneca, Gaithersburg, MD (M.P.G., Y.Y., T.T., M.T.E., A.A.K., F.D., T.V.); SUNY Upstate Medical University, Syracuse, NY (J.B.D.); Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, and Department of Science and Technology/National Research Foundation South African Research Chair, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (S.A.M.); the Division of Pediatrics and Neonatology, Department of Maternal, Neonatal, and Infant Medicine, Nuovo Ospedale Degli Infermi, Biella, and Neonatology and NICU, Sant'Anna Hospital, AOU Città della Salute e della Scienza, Turin - both in Italy (P.M.); the University of Colorado School of Medicine, Aurora (E.A.F.S.); and the Children's Foundation Research Institute at Le Bonheur Children's Hospital, Memphis, TN (J.P.D.V.).""}, {'ForeName': 'Therese', 'Initials': 'T', 'LastName': 'Takas', 'Affiliation': ""From AstraZeneca, Gaithersburg, MD (M.P.G., Y.Y., T.T., M.T.E., A.A.K., F.D., T.V.); SUNY Upstate Medical University, Syracuse, NY (J.B.D.); Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, and Department of Science and Technology/National Research Foundation South African Research Chair, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (S.A.M.); the Division of Pediatrics and Neonatology, Department of Maternal, Neonatal, and Infant Medicine, Nuovo Ospedale Degli Infermi, Biella, and Neonatology and NICU, Sant'Anna Hospital, AOU Città della Salute e della Scienza, Turin - both in Italy (P.M.); the University of Colorado School of Medicine, Aurora (E.A.F.S.); and the Children's Foundation Research Institute at Le Bonheur Children's Hospital, Memphis, TN (J.P.D.V.).""}, {'ForeName': 'Joseph B', 'Initials': 'JB', 'LastName': 'Domachowske', 'Affiliation': ""From AstraZeneca, Gaithersburg, MD (M.P.G., Y.Y., T.T., M.T.E., A.A.K., F.D., T.V.); SUNY Upstate Medical University, Syracuse, NY (J.B.D.); Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, and Department of Science and Technology/National Research Foundation South African Research Chair, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (S.A.M.); the Division of Pediatrics and Neonatology, Department of Maternal, Neonatal, and Infant Medicine, Nuovo Ospedale Degli Infermi, Biella, and Neonatology and NICU, Sant'Anna Hospital, AOU Città della Salute e della Scienza, Turin - both in Italy (P.M.); the University of Colorado School of Medicine, Aurora (E.A.F.S.); and the Children's Foundation Research Institute at Le Bonheur Children's Hospital, Memphis, TN (J.P.D.V.).""}, {'ForeName': 'Shabir A', 'Initials': 'SA', 'LastName': 'Madhi', 'Affiliation': ""From AstraZeneca, Gaithersburg, MD (M.P.G., Y.Y., T.T., M.T.E., A.A.K., F.D., T.V.); SUNY Upstate Medical University, Syracuse, NY (J.B.D.); Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, and Department of Science and Technology/National Research Foundation South African Research Chair, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (S.A.M.); the Division of Pediatrics and Neonatology, Department of Maternal, Neonatal, and Infant Medicine, Nuovo Ospedale Degli Infermi, Biella, and Neonatology and NICU, Sant'Anna Hospital, AOU Città della Salute e della Scienza, Turin - both in Italy (P.M.); the University of Colorado School of Medicine, Aurora (E.A.F.S.); and the Children's Foundation Research Institute at Le Bonheur Children's Hospital, Memphis, TN (J.P.D.V.).""}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Manzoni', 'Affiliation': ""From AstraZeneca, Gaithersburg, MD (M.P.G., Y.Y., T.T., M.T.E., A.A.K., F.D., T.V.); SUNY Upstate Medical University, Syracuse, NY (J.B.D.); Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, and Department of Science and Technology/National Research Foundation South African Research Chair, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (S.A.M.); the Division of Pediatrics and Neonatology, Department of Maternal, Neonatal, and Infant Medicine, Nuovo Ospedale Degli Infermi, Biella, and Neonatology and NICU, Sant'Anna Hospital, AOU Città della Salute e della Scienza, Turin - both in Italy (P.M.); the University of Colorado School of Medicine, Aurora (E.A.F.S.); and the Children's Foundation Research Institute at Le Bonheur Children's Hospital, Memphis, TN (J.P.D.V.).""}, {'ForeName': 'Eric A F', 'Initials': 'EAF', 'LastName': 'Simões', 'Affiliation': ""From AstraZeneca, Gaithersburg, MD (M.P.G., Y.Y., T.T., M.T.E., A.A.K., F.D., T.V.); SUNY Upstate Medical University, Syracuse, NY (J.B.D.); Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, and Department of Science and Technology/National Research Foundation South African Research Chair, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (S.A.M.); the Division of Pediatrics and Neonatology, Department of Maternal, Neonatal, and Infant Medicine, Nuovo Ospedale Degli Infermi, Biella, and Neonatology and NICU, Sant'Anna Hospital, AOU Città della Salute e della Scienza, Turin - both in Italy (P.M.); the University of Colorado School of Medicine, Aurora (E.A.F.S.); and the Children's Foundation Research Institute at Le Bonheur Children's Hospital, Memphis, TN (J.P.D.V.).""}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Esser', 'Affiliation': ""From AstraZeneca, Gaithersburg, MD (M.P.G., Y.Y., T.T., M.T.E., A.A.K., F.D., T.V.); SUNY Upstate Medical University, Syracuse, NY (J.B.D.); Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, and Department of Science and Technology/National Research Foundation South African Research Chair, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (S.A.M.); the Division of Pediatrics and Neonatology, Department of Maternal, Neonatal, and Infant Medicine, Nuovo Ospedale Degli Infermi, Biella, and Neonatology and NICU, Sant'Anna Hospital, AOU Città della Salute e della Scienza, Turin - both in Italy (P.M.); the University of Colorado School of Medicine, Aurora (E.A.F.S.); and the Children's Foundation Research Institute at Le Bonheur Children's Hospital, Memphis, TN (J.P.D.V.).""}, {'ForeName': 'Anis A', 'Initials': 'AA', 'LastName': 'Khan', 'Affiliation': ""From AstraZeneca, Gaithersburg, MD (M.P.G., Y.Y., T.T., M.T.E., A.A.K., F.D., T.V.); SUNY Upstate Medical University, Syracuse, NY (J.B.D.); Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, and Department of Science and Technology/National Research Foundation South African Research Chair, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (S.A.M.); the Division of Pediatrics and Neonatology, Department of Maternal, Neonatal, and Infant Medicine, Nuovo Ospedale Degli Infermi, Biella, and Neonatology and NICU, Sant'Anna Hospital, AOU Città della Salute e della Scienza, Turin - both in Italy (P.M.); the University of Colorado School of Medicine, Aurora (E.A.F.S.); and the Children's Foundation Research Institute at Le Bonheur Children's Hospital, Memphis, TN (J.P.D.V.).""}, {'ForeName': 'Filip', 'Initials': 'F', 'LastName': 'Dubovsky', 'Affiliation': ""From AstraZeneca, Gaithersburg, MD (M.P.G., Y.Y., T.T., M.T.E., A.A.K., F.D., T.V.); SUNY Upstate Medical University, Syracuse, NY (J.B.D.); Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, and Department of Science and Technology/National Research Foundation South African Research Chair, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (S.A.M.); the Division of Pediatrics and Neonatology, Department of Maternal, Neonatal, and Infant Medicine, Nuovo Ospedale Degli Infermi, Biella, and Neonatology and NICU, Sant'Anna Hospital, AOU Città della Salute e della Scienza, Turin - both in Italy (P.M.); the University of Colorado School of Medicine, Aurora (E.A.F.S.); and the Children's Foundation Research Institute at Le Bonheur Children's Hospital, Memphis, TN (J.P.D.V.).""}, {'ForeName': 'Tonya', 'Initials': 'T', 'LastName': 'Villafana', 'Affiliation': ""From AstraZeneca, Gaithersburg, MD (M.P.G., Y.Y., T.T., M.T.E., A.A.K., F.D., T.V.); SUNY Upstate Medical University, Syracuse, NY (J.B.D.); Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, and Department of Science and Technology/National Research Foundation South African Research Chair, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (S.A.M.); the Division of Pediatrics and Neonatology, Department of Maternal, Neonatal, and Infant Medicine, Nuovo Ospedale Degli Infermi, Biella, and Neonatology and NICU, Sant'Anna Hospital, AOU Città della Salute e della Scienza, Turin - both in Italy (P.M.); the University of Colorado School of Medicine, Aurora (E.A.F.S.); and the Children's Foundation Research Institute at Le Bonheur Children's Hospital, Memphis, TN (J.P.D.V.).""}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'DeVincenzo', 'Affiliation': ""From AstraZeneca, Gaithersburg, MD (M.P.G., Y.Y., T.T., M.T.E., A.A.K., F.D., T.V.); SUNY Upstate Medical University, Syracuse, NY (J.B.D.); Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, and Department of Science and Technology/National Research Foundation South African Research Chair, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (S.A.M.); the Division of Pediatrics and Neonatology, Department of Maternal, Neonatal, and Infant Medicine, Nuovo Ospedale Degli Infermi, Biella, and Neonatology and NICU, Sant'Anna Hospital, AOU Città della Salute e della Scienza, Turin - both in Italy (P.M.); the University of Colorado School of Medicine, Aurora (E.A.F.S.); and the Children's Foundation Research Institute at Le Bonheur Children's Hospital, Memphis, TN (J.P.D.V.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1913556']
2368,32735782,"Cannabidiol for the treatment of cannabis use disorder: a phase 2a, double-blind, placebo-controlled, randomised, adaptive Bayesian trial.","Background A substantial and unmet clinical need exists for pharmacological treatment of cannabis use disorders. Cannabidiol could offer a novel treatment, but it is unclear which doses might be efficacious or safe. Therefore, we aimed to identify efficacious doses and eliminate inefficacious doses in a phase 2a trial using an adaptive Bayesian design.
METHODS


We did a phase 2a, double-blind, placebo-controlled, randomised, adaptive Bayesian trial at the Clinical Psychopharmacology Unit (University College London, London, UK). We used an adaptive Bayesian dose-finding design to identify efficacious or inefficacious doses at a-priori interim and final analysis stages. Participants meeting cannabis use disorder criteria from DSM-5 were randomly assigned (1:1:1:1) in the first stage of the trial to 4-week treatment with three different doses of oral cannabidiol (200 mg, 400 mg, or 800 mg) or with matched placebo during a cessation attempt by use of a double-blinded block randomisation sequence. All participants received a brief psychological intervention of motivational interviewing. For the second stage of the trial, new participants were randomly assigned to placebo or doses deemed efficacious in the interim analysis. The primary objective was to identify the most efficacious dose of cannabidiol for reducing cannabis use. The primary endpoints were lower urinary 11-nor-9-carboxy-δ-9-tetrahydrocannabinol (THC-COOH):creatinine ratio, increased days per week with abstinence from cannabis during treatment, or both, evidenced by posterior probabilities that cannabidiol is better than placebo exceeding 0·9. All analyses were done on an intention-to-treat basis. This trial is registered with ClinicalTrials.gov (NCT02044809) and the EU Clinical Trials Register (2013-000361-36).
FINDINGS


Between May 28, 2014, and Aug 12, 2015 (first stage), 48 participants were randomly assigned to placebo (n=12) and to cannabidiol 200 mg (n=12), 400 mg (n=12), and 800 mg (n=12). At interim analysis, cannabidiol 200 mg was eliminated from the trial as an inefficacious dose. Between May 24, 2016, and Jan 12, 2017 (second stage), randomisation continued and an additional 34 participants were allocated (1:1:1) to cannabidiol 400 mg (n=12), cannabidiol 800 mg (n=11), and placebo (n=11). At final analysis, cannabidiol 400 mg and 800 mg exceeded primary endpoint criteria (0·9) for both primary outcomes. For urinary THC-COOH:creatinine ratio, the probability of being the most efficacious dose compared with placebo given the observed data was 0·9995 for cannabidiol 400 mg and 0·9965 for cannabidiol 800 mg. For days with abstinence from cannabis, the probability of being the most efficacious dose compared with placebo given the observed data was 0·9966 for cannabidiol 400 mg and 0·9247 for cannabidiol 800 mg. Compared with placebo, cannabidiol 400 mg decreased THC-COOH:creatinine ratio by -94·21 ng/mL (95% interval estimate -161·83 to -35·56) and increased abstinence from cannabis by 0·48 days per week (0·15 to 0·82). Compared with placebo, cannabidiol 800 mg decreased THC-COOH:creatinine ratio by -72·02 ng/mL (-135·47 to -19·52) and increased abstinence from cannabis by 0·27 days per week (-0·09 to 0·64). Cannabidiol was well tolerated, with no severe adverse events recorded, and 77 (94%) of 82 participants completed treatment.
INTERPRETATION


In the first randomised clinical trial of cannabidiol for cannabis use disorder, cannabidiol 400 mg and 800 mg were safe and more efficacious than placebo at reducing cannabis use.
FUNDING


Medical Research Council.",2020,"Cannabidiol was well tolerated, with no severe adverse events recorded, and 77 (94%) of 82 participants completed treatment.
","['48 participants', 'Participants meeting cannabis use disorder criteria from DSM-5', 'Between May 28, 2014, and Aug 12, 2015 (first stage']","['placebo', 'oral cannabidiol', 'placebo, cannabidiol', 'brief psychological intervention of motivational interviewing', 'cannabidiol 400 mg (n=12), cannabidiol 800 mg (n=11), and placebo']","['THC-COOH:creatinine ratio', 'lower urinary 11-nor-9-carboxy-δ-9-tetrahydrocannabinol (THC-COOH):creatinine ratio']","[{'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C3160814', 'cui_str': 'Cannabis use'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0006863', 'cui_str': 'Cannabidiol'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C3844106', 'cui_str': '800'}]","[{'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",48.0,0.767603,"Cannabidiol was well tolerated, with no severe adverse events recorded, and 77 (94%) of 82 participants completed treatment.
","[{'ForeName': 'Tom P', 'Initials': 'TP', 'LastName': 'Freeman', 'Affiliation': ""Addiction and Mental Health Group, Department of Psychology, University of Bath, Bath, UK; Clinical Psychopharmacology Unit, University College London, London, UK; Translational Psychiatry Research Group, Research Department of Mental Health Neuroscience, Division of Psychiatry, University College London, London, UK; National Addiction Centre, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK. Electronic address: t.p.freeman@bath.ac.uk.""}, {'ForeName': 'Chandni', 'Initials': 'C', 'LastName': 'Hindocha', 'Affiliation': 'Clinical Psychopharmacology Unit, University College London, London, UK; Translational Psychiatry Research Group, Research Department of Mental Health Neuroscience, Division of Psychiatry, University College London, London, UK; National Institute for Health Research University College London Hospitals Biomedical Research Centre, London, UK.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Baio', 'Affiliation': 'Department of Statistical Science, University College London, London, UK.'}, {'ForeName': 'Natacha D C', 'Initials': 'NDC', 'LastName': 'Shaban', 'Affiliation': 'Clinical Psychopharmacology Unit, University College London, London, UK.'}, {'ForeName': 'Emily M', 'Initials': 'EM', 'LastName': 'Thomas', 'Affiliation': 'Clinical Psychopharmacology Unit, University College London, London, UK.'}, {'ForeName': 'Danica', 'Initials': 'D', 'LastName': 'Astbury', 'Affiliation': 'Clinical Psychopharmacology Unit, University College London, London, UK.'}, {'ForeName': 'Abigail M', 'Initials': 'AM', 'LastName': 'Freeman', 'Affiliation': 'Clinical Psychopharmacology Unit, University College London, London, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Lees', 'Affiliation': 'Addiction and Mental Health Group, Department of Psychology, University of Bath, Bath, UK.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Craft', 'Affiliation': ""Addiction and Mental Health Group, Department of Psychology, University of Bath, Bath, UK; National Addiction Centre, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Paul D', 'Initials': 'PD', 'LastName': 'Morrison', 'Affiliation': ""Department of Psychosis Studies, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Michael A P', 'Initials': 'MAP', 'LastName': 'Bloomfield', 'Affiliation': 'Clinical Psychopharmacology Unit, University College London, London, UK; Translational Psychiatry Research Group, Research Department of Mental Health Neuroscience, Division of Psychiatry, University College London, London, UK; National Institute for Health Research University College London Hospitals Biomedical Research Centre, London, UK; The Traumatic Stress Clinic, St Pancras Hospital, Camden and Islington National Health Service Foundation Trust, London, UK; Pain Management Centre, National Hospital for Neurology and Neurosurgery, University College London Hospitals, London, UK.'}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': ""O'Ryan"", 'Affiliation': 'Substance Misuse Services, Camden and Islington National Health Service Foundation Trust, London, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Kinghorn', 'Affiliation': 'Translational Research Office, School of Life and Medical Sciences, University College London, London, UK.'}, {'ForeName': 'Celia J A', 'Initials': 'CJA', 'LastName': 'Morgan', 'Affiliation': 'Psychopharmacology and Addiction Research Centre, University of Exeter, Exeter, UK.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Mofeez', 'Affiliation': 'Pain Management Centre, National Hospital for Neurology and Neurosurgery, University College London Hospitals, London, UK.'}, {'ForeName': 'H Valerie', 'Initials': 'HV', 'LastName': 'Curran', 'Affiliation': 'Clinical Psychopharmacology Unit, University College London, London, UK; National Institute for Health Research University College London Hospitals Biomedical Research Centre, London, UK.'}]",The lancet. Psychiatry,['10.1016/S2215-0366(20)30290-X']
2369,32739509,Reducing hyperpigmentation after sclerotherapy: A randomized clinical trial.,"OBJECTIVE


Sclerotherapy for the treatment of varicose veins is one of the most common medical procedures performed in the Western world, and hyperpigmentation is one of the most frequent, dreaded, minor adverse events. There has recently been some interest in investigating the inflammatory response of the local endothelium after sclerotherapy and the possible benefits of venoactive drugs because of their pleiotropic properties. The aim of this study was to evaluate whether adding a venoactive drug (sulodexide) to the standard sclerotherapy treatment protocol for patients with varicose veins can reduce the occurrence of postsclerotherapy hyperpigmentation.
METHODS


We carried out a prospective, multicenter, randomized controlled trial with a parallel group design. It included 720 patients with telangiectasia, reticular veins, or varicose veins who were candidates for sclerotherapy. Patients with reflux in deep system or saphenous veins were excluded. Group A consisted of 354 patients who received an oral dose of sulodexide twice a day for 7 days before scheduled sclerotherapy; the treatment then continued for 3 months. Group B consisted of 366 patients who received the standard sclerotherapy protocol. Polidocanol was used as the sclerosing agent, and 20 to 30 mm Hg compression stockings were used in both groups for 7 days. Control photographs were taken, and a follow-up examination took place after 1 month and 3 months. Computer software was used to analyze the treated area for incidence of hyperpigmentation, total area of hyperpigmentation, skin tone increase in the hyperpigmented area, vein disappearance, and incidence of major bleeding. The sample size was calculated to give a statistical power of 80%. Student t-test and the χ 2  test were used for comparative analyses, as appropriate. The level of significance was set at P < .05.
RESULTS


A total of 609 patients completed the 3-month follow-up: 312 in group A and 297 in group B. After 1 month, the incidence of hyperpigmentation was 8.7% in group A and 14.8% in group B (P = .01). Group A developed an average area of hyperpigmentation of 10.7% compared with 18.2% in group B (P = .01), and the skin tone of the hyperpigmented area was lower in group A than in group B (P = .02). However, the latter difference was not significant after 3 months. The overall vein disappearance rate was similar in both groups.
CONCLUSIONS


Our analysis shows that by adding a venoactive drug (sulodexide) to the standard sclerotherapy protocol, the occurrence of hyperpigmentation is reduced without affecting the desired therapeutic vein elimination response.",2020,"Group A developed an average area of hyperpigmentation of 10.7% compared with 18.2% in group B (p=0.01), and the skin tone of the hyperpigmented area was lower in group A than in group B (p=0.02).","['609 patients completed the 3-month follow-up: 312 in group A and 297 in group', 'Patients with reflux in deep system or saphenous veins were excluded', '354 patients', 'patients with varicose veins', '720 patients with telangiectasia, reticular or varicose veins who were candidates for sclerotherapy']","['venoactive drug (sulodexide', 'standard sclerotherapy protocol', 'standard sclerotherapy treatment protocol', 'sulodexide', 'Polidocanol', 'sclerotherapy']","['incidence of hyperpigmentation, total area of hyperpigmentation, skin tone increase in the hyperpigmented area, vein disappearance, and incidence of major bleeding', 'incidence of hyperpigmentation', 'average area of hyperpigmentation', 'skin tone of the hyperpigmented area', 'overall vein disappearance rate', 'Hyperpigmentation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C4517706', 'cui_str': '312'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4317146', 'cui_str': 'Acid reflux'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0036186', 'cui_str': 'Saphenous vein structure'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0042345', 'cui_str': 'Phlebectasia'}, {'cui': 'C4517865', 'cui_str': '720'}, {'cui': 'C0039446', 'cui_str': 'Telangiectasis'}, {'cui': 'C0439739', 'cui_str': 'Reticular'}, {'cui': 'C0036435', 'cui_str': 'Injection of sclerosing agent'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0061450', 'cui_str': 'sulodexide'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0036435', 'cui_str': 'Injection of sclerosing agent'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0071330', 'cui_str': 'polidocanol'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0162834', 'cui_str': 'Hyperpigmentation'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0037290', 'cui_str': 'Skin pigmentation'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",720.0,0.0554183,"Group A developed an average area of hyperpigmentation of 10.7% compared with 18.2% in group B (p=0.01), and the skin tone of the hyperpigmented area was lower in group A than in group B (p=0.02).","[{'ForeName': 'Alejandro Jose', 'Initials': 'AJ', 'LastName': 'Gonzalez Ochoa', 'Affiliation': 'HGZ 12 Instituto Mexicano del Seguro Social, San Luis Rio Colorado, Sonora, Mexico; CLINEDEM, San Luis Rio Colorado, Sonora, Mexico. Electronic address: alex8as2@yahoo.com.mx.'}, {'ForeName': 'Joaquín', 'Initials': 'J', 'LastName': 'Carrillo', 'Affiliation': 'Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado, Mexicali, Baja California, Mexico.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Manríquez', 'Affiliation': 'Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado, Mexicali, Baja California, Mexico.'}, {'ForeName': 'Flavio', 'Initials': 'F', 'LastName': 'Manrique', 'Affiliation': 'Hospital General Tijuana, Tijuana, Baja California, Mexico.'}, {'ForeName': 'Alejandro Nuricumbo', 'Initials': 'AN', 'LastName': 'Vazquez', 'Affiliation': 'Instituto de Seguridad y Servicios Sociales de los Trabajadores del Gobierno y Municipios del Estado Baja California, Mexicali, Baja California, Mexico.'}]",Journal of vascular surgery. Venous and lymphatic disorders,['10.1016/j.jvsv.2020.06.019']
2370,32739184,Re: Ang et al.: Randomized clinical trial comparing femtosecond LASIK and small-incision lenticule extraction (Ophthalmology. 2020;127:724-730).,,2020,,[],['femtosecond LASIK and small-incision lenticule extraction'],[],[],"[{'cui': 'C0752094', 'cui_str': 'Laser assisted in situ keratomileusis'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}]",[],,0.0877184,,"[{'ForeName': 'Avi', 'Initials': 'A', 'LastName': 'Wallerstein', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, McGill University, Montreal, Quebec, Canada; LASIK MD, Montreal, Quebec, Canada. Electronic address: awallerstein@lasikmd.com.'}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Gauvin', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, McGill University, Montreal, Quebec, Canada; LASIK MD, Montreal, Quebec, Canada.'}]",Ophthalmology,['10.1016/j.ophtha.2020.06.032']
2371,32734413,The effect of an educational video on long-acting reversible contraception (LARC) utilization at 6-8 weeks postpartum period: a randomized controlled trial.,"PURPOSE


Long-acting reversible contraception is highly effective in preventing unintended pregnancy and unsafe abortion. An educational video administered during early postpartum period might be an effective tool to improve postpartum LARC use. The objectives were to evaluate whether a postpartum educational video about LARC could increase postpartum LARC utilization at 6-8 weeks postpartum and to assess why postpartum women did not receive LARC.
METHODS


This randomized-controlled trial was conducted at the postpartum unit of a university Hospital between August 2016 and February 2017. Postpartum women who were aged > 20 years and willing to participate were recruited. Participants allocated to the study group watched the 7-min educational video on LARC methods while the control group did not. To assess LARC utilization, data were collected at 6-8 weeks postpartum using telephone calls and/or medical record review to determine postpartum contraception use and reasons for not using LARC.
RESULTS


Two-hundred and seventy participants were enrolled, and the video (135) and non-video (135) groups had similar baseline characteristics. In the video group, 57.8% (95% CI 49.0-66.2) reported using a LARC method, compared to 25.9% (95% CI 18.8-34.2) in the non-video group (p < 0.05). The reasons for not using LARC in both groups were inconvenience of access (42.0-43.8%) and uncertainty about methods (17.0-24.6%).
CONCLUSION


The educational video introduced at immediate postpartum period was efficacious in increasing the utilization of LARC at 6-8 weeks postpartum. Inconvenience of access was the most common reason cited for not using LARC.
CLINICAL TRIAL REGISTRATION NUMBER


Clinicaltrials.in.th TCTR20171225001 ""retrospectively registered"".",2020,The educational video introduced at immediate postpartum period was efficacious in increasing the utilization of LARC at 6-8 weeks postpartum.,"['Two-hundred and seventy participants were enrolled, and the video (135) and non-video (135) groups had similar baseline characteristics', 'Postpartum women who were aged\u2009', 'postpartum unit of a university Hospital between August 2016 and February 2017', '20\xa0years and willing to participate were recruited']","['educational video on long-acting reversible contraception (LARC) utilization', 'postpartum educational video about LARC']",['postpartum LARC utilization'],"[{'cui': 'C4319603', 'cui_str': '270'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0032804', 'cui_str': 'Postpartum Women'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0600109', 'cui_str': 'Willing'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C4505307', 'cui_str': 'Long-Acting Reversible Contraception'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}]","[{'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",270.0,0.264079,The educational video introduced at immediate postpartum period was efficacious in increasing the utilization of LARC at 6-8 weeks postpartum.,"[{'ForeName': 'Chada', 'Initials': 'C', 'LastName': 'Burapasikarin', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Rama VI Rd., Bangkok, 10400, Thailand.'}, {'ForeName': 'Jittima', 'Initials': 'J', 'LastName': 'Manonai', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Rama VI Rd., Bangkok, 10400, Thailand. jittima.man@mahidol.ac.th.'}, {'ForeName': 'Rujira', 'Initials': 'R', 'LastName': 'Wattanayingcharoenchai', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Rama VI Rd., Bangkok, 10400, Thailand.'}]",Archives of gynecology and obstetrics,['10.1007/s00404-020-05710-3']
2372,32730977,"Bumetanide for Core Symptoms of Autism Spectrum Disorder (BAMBI): A Single Center, Double-Blinded, Participant-Randomized, Placebo-Controlled, Phase-2 Superiority Trial.","OBJECTIVE


Recent trials have indicated positive effects of bumetanide in autism spectrum disorder (ASD). We tested efficacy of bumetanide on core symptom domains using a single center, parallel-group, participant-randomized, double-blind, placebo-controlled phase-2 superiority trial in a tertiary hospital in the Netherlands.
METHOD


Unmedicated children aged 7 to 15 years with ASD and IQ ≥55 were block-randomized 1:1 to oral-solution bumetanide versus placebo, titrated to a maximum of 1.0 mg twice daily for 91 days (D91), followed by a 28-day wash-out period. The primary outcome was difference in Social Responsiveness Scale-2 (SRS-2) total score at D91, analyzed by modified intention-to-treat with linear mixed models.
RESULTS


A total of 92 participants (mean age 10.5 [SD 2.4] years) enrolled between June 2016 and December 2018. In all, 47 children were allocated to bumetanide and 45 to placebo. Two participants dropped out per treatment arm. After 91 days, bumetanide was not superior to placebo on the primary outcome, the SRS-2 (mean difference -3.16, 95% CI = -9.68 to 3.37, p = .338). A superior effect was found on one of the secondary outcomes, the Repetitive Behavior Scale-Revised (mean difference -4.16, 95% CI = -8.06 to -0.25, p = .0375), but not on the Sensory Profile (mean difference 5.64, 95% CI = -11.30 to 22.57, p = .508) or the Aberrant Behavior Checklist Irritability Subscale (mean difference -0.65, 95% CI = -2.83 to 1.52, p = .552). No significant wash-out effect was observed. Significant adverse effects were predominantly diuretic effects (orthostatic hypotension (17 [36%] versus 5 [11%], p = .007); hypokalemia (24 [51%] versus 0 [0%], p < .0001), the occurrence of which did not statistically influence treatment outcome.
CONCLUSION


The trial outcome was negative in terms of no superior effect on the primary outcome. The secondary outcomes suggest efficacy on repetitive behavior symptoms for a subset of patients.
CLINICAL TRIAL REGISTRATION INFORMATION


Bumetanide in Autism Medication and Biomarker Study (BAMBI); https://www.clinicaltrialsregister.eu/; 2014-001560-35.",2020,"After 91 days, bumetanide was not superior to placebo on the primary outcome, the SRS-2","['92 participants (mean age 10.5 years [SD 2.4]) enrolled between June 2016 and December 2018', 'Autism Spectrum Disorder (BAMBI', 'autism spectrum disorder (ASD', '47 children', 'Unmedicated children aged 7-15 with ASD and IQ>55 were block-randomized 1:1 to']","['bumetanide', 'oral-solution bumetanide vs. placebo', 'Placebo', 'Bumetanide', 'placebo']","['SRS-2', 'diuretic effects (orthostatic hypotension', 'Repetitive Behavior Scale-Revised', 'Sensory Profile', 'repetitive behavior symptoms', 'Social Responsiveness Scale-2 (SRS-2) total score at D91 analyzed by modified intention-to-treat with linear mixed models', 'hypokalemia', 'Aberrant Behavior Checklist Irritability Subscale']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517521', 'cui_str': '10.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517631', 'cui_str': '2.4'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C1436698', 'cui_str': 'BAMBI protein, human'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}]","[{'cui': 'C0006376', 'cui_str': 'Bumetanide'}, {'cui': 'C0991536', 'cui_str': 'Oral solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0948429', 'cui_str': 'Diuretic Effects'}, {'cui': 'C0020651', 'cui_str': 'Orthostatic hypotension'}, {'cui': 'C1827547', 'cui_str': 'Repetitious behavior'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C2732625', 'cui_str': 'Sensory profile'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0020621', 'cui_str': 'Hypokalemia'}, {'cui': 'C0443127', 'cui_str': 'Aberrant'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0022107', 'cui_str': 'Feeling irritable'}]",47.0,0.766947,"After 91 days, bumetanide was not superior to placebo on the primary outcome, the SRS-2","[{'ForeName': 'Jan J', 'Initials': 'JJ', 'LastName': 'Sprengers', 'Affiliation': 'UMC Utrecht Brain Centre, University Medical Centre Utrecht, the Netherlands.'}, {'ForeName': 'Dorinde M', 'Initials': 'DM', 'LastName': 'van Andel', 'Affiliation': 'UMC Utrecht Brain Centre, University Medical Centre Utrecht, the Netherlands.'}, {'ForeName': 'Nicolaas P A', 'Initials': 'NPA', 'LastName': 'Zuithoff', 'Affiliation': 'Julius Centre for Health Sciences and Primary Care, University Medical Centre Utrecht, the Netherlands.'}, {'ForeName': 'Mandy G', 'Initials': 'MG', 'LastName': 'Keijzer-Veen', 'Affiliation': ""Wilhelmina Children's Hospital, University Medical Centre Utrecht, the Netherlands.""}, {'ForeName': 'Annelien J A', 'Initials': 'AJA', 'LastName': 'Schulp', 'Affiliation': ""Wilhelmina Children's Hospital, University Medical Centre Utrecht, the Netherlands.""}, {'ForeName': 'Floortje E', 'Initials': 'FE', 'LastName': 'Scheepers', 'Affiliation': 'UMC Utrecht Brain Centre, University Medical Centre Utrecht, the Netherlands.'}, {'ForeName': 'Marc R', 'Initials': 'MR', 'LastName': 'Lilien', 'Affiliation': ""Wilhelmina Children's Hospital, University Medical Centre Utrecht, the Netherlands.""}, {'ForeName': 'Bob', 'Initials': 'B', 'LastName': 'Oranje', 'Affiliation': 'UMC Utrecht Brain Centre, University Medical Centre Utrecht, the Netherlands.'}, {'ForeName': 'Hilgo', 'Initials': 'H', 'LastName': 'Bruining', 'Affiliation': 'UMC Utrecht Brain Centre, University Medical Centre Utrecht, the Netherlands; Amsterdam UMC, Vrije Universiteit Amsterdam, N=You centre, Amsterdam Neuroscience, Amsterdam Reproduction and Development, the Netherlands. Electronic address: h.bruining@amsterdamumc.nl.'}]",Journal of the American Academy of Child and Adolescent Psychiatry,['10.1016/j.jaac.2020.07.888']
2373,32735514,Treatment Outcomes of a Multi-Component Mobile Health Smoking Cessation Pilot Intervention for People with Schizophrenia.,"OBJECTIVE


The objective of this study was to investigate the feasibility and acceptability of a multi-component mobile contingency management (CM) pilot intervention for smoking cessation for people with schizophrenia.  Methods:  This intervention included mobile CM (i.e., monetary compensation for bioverification of abstinence through using a phone app), cognitive behavioral therapy (CBT), and pharmacotherapy for smoking cessation. This intervention was compared to an intensive treatment comparison (ITC), which contained all components except the CM. Participants were bioverified with carbon monoxide and saliva cotinine at a 6-month follow-up session.  Results:  In this pilot, the treatment group did not differ from the ITC at any time point. However, measures of treatment feasibility and acceptability indicated that smokers with schizophrenia were able to navigate the CM phone application and adhere to the protocol, demonstrating the potential utility of mobile interventions in this population.  Conclusions:  Despite lack of long-term abstinence for participants, adherence to the mobile application intervention indicates the potential for future investigation of mobile smoking cessation treatments for people with schizophrenia.",2020,"However, measures of treatment feasibility and acceptability indicated that smokers with schizophrenia were able to navigate the CM phone application and adhere to the protocol, demonstrating the potential utility of mobile interventions in this population.  ","['People with Schizophrenia', 'people with schizophrenia', 'smokers with schizophrenia']","['multi-component mobile contingency management (CM) pilot intervention', 'mobile CM (i.e., monetary compensation for bioverification of abstinence through using a phone app), cognitive behavioral therapy (CBT), and pharmacotherapy for smoking cessation', 'Multi-Component Mobile Health Smoking Cessation Pilot Intervention']","['feasibility and acceptability', 'bioverified with carbon monoxide and saliva cotinine']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0152057', 'cui_str': 'Compensation'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0010194', 'cui_str': 'Cotinine'}]",,0.0259744,"However, measures of treatment feasibility and acceptability indicated that smokers with schizophrenia were able to navigate the CM phone application and adhere to the protocol, demonstrating the potential utility of mobile interventions in this population.  ","[{'ForeName': 'Alyssa M', 'Initials': 'AM', 'LastName': 'Medenblik', 'Affiliation': 'Durham Veterans Affairs Health Care System, Durham, North Carolina, USA.'}, {'ForeName': 'Adam M', 'Initials': 'AM', 'LastName': 'Mann', 'Affiliation': 'Durham Veterans Affairs Health Care System, Durham, North Carolina, USA.'}, {'ForeName': 'Tiffany A', 'Initials': 'TA', 'LastName': 'Beaver', 'Affiliation': 'Durham Veterans Affairs Health Care System, Durham, North Carolina, USA.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Dedert', 'Affiliation': 'Durham Veterans Affairs Health Care System, Durham, North Carolina, USA.'}, {'ForeName': 'Sarah M', 'Initials': 'SM', 'LastName': 'Wilson', 'Affiliation': 'Durham Veterans Affairs Health Care System, Durham, North Carolina, USA.'}, {'ForeName': 'Patrick S', 'Initials': 'PS', 'LastName': 'Calhoun', 'Affiliation': 'Durham Veterans Affairs Health Care System, Durham, North Carolina, USA.'}, {'ForeName': 'Jean C', 'Initials': 'JC', 'LastName': 'Beckham', 'Affiliation': 'Durham Veterans Affairs Health Care System, Durham, North Carolina, USA.'}]",Journal of dual diagnosis,['10.1080/15504263.2020.1797259']
2374,32739411,Apple polyphenol-rich drinks dose-dependently decrease early-phase postprandial glucose concentrations following a high-carbohydrate meal: a randomized controlled trial in healthy adults and in vitro studies.,"BACKGROUND


Previous research demonstrated that a high dose of phlorizin-rich apple extract (AE) can markedly inhibit early-phase postprandial glycemia, but efficacy of lower doses of the AE is unclear.
OBJECTIVE


To determine whether lower AE doses reduce early-phase postprandial glycemia in healthy adults and investigate mechanisms.
DESIGN


In a randomized, controlled, double-blinded, cross-over acute trial, drinks containing 1.8 g (HIGH), 1.35 g (MED), 0.9 g (LOW), or 0 g (CON) of a phlorizin-rich AE were consumed before 75 g starch/sucrose meal. Postprandial blood glucose, insulin, C-peptide, glucose-dependent insulinotropic polypeptide (GIP) and polyphenol metabolites concentrations were measured 0-240 min, acetaminophen concentrations to assess gastric emptying rate, and 24 h urinary glucose excretion. Effects of AE on intestinal glucose transport were investigated in Caco-2/TC7 cells.
RESULTS


AE significantly reduced plasma glucose iAUC 0-30 min at all doses: mean differences (95% CI) relative to CON were -15.6 (-23.3, -7.9), -11.3 (-19.6, -3.0) and -8.99 (-17.3, -0.7) mmol/L per minute for HIGH, MEDIUM and LOW respectively, delayed T max  (HIGH, MEDIUM and LOW 45 min vs. CON 30 min), but did not lower C max . Similar dose-dependent treatment effects were observed for insulin, C-peptide, and GIP. Gastric emptying rates and urinary glucose excretion did not differ. Serum phloretin, quercetin and epicatechin metabolites were detected postprandially. A HIGH physiological AE dose equivalent decreased total glucose uptake by 48% in Caco-2/TC7 cells.
CONCLUSIONS


Phlorizin-rich AE, even at a low dose, can slightly delay early-phase glycemia without affecting peak and total glycemic response.",2020,"RESULTS


AE significantly reduced plasma glucose iAUC 0-30 min at all doses: mean differences (95% CI) relative to CON were-15.6 (-23.3, -7.9), -11.3 (-19.6, -3.0)",['healthy adults'],"['Apple polyphenol-rich drinks', 'phlorizin-rich apple extract (AE', 'AE', 'phlorizin-rich AE were consumed before 75 g starch/sucrose meal']","['Postprandial blood glucose, insulin, C-peptide, glucose-dependent insulinotropic polypeptide (GIP) and polyphenol metabolites concentrations', 'gastric emptying rate, and 24 h urinary glucose excretion', 'total glucose uptake', 'Serum phloretin, quercetin and epicatechin metabolites', 'Gastric emptying rates and urinary glucose excretion', 'total glycaemic response', 'insulin, C-peptide, and GIP', 'early-phase postprandial glucose concentrations', 'plasma glucose iAUC', 'delayed T max  ', 'intestinal glucose transport']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0003625', 'cui_str': 'Malus'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0031562', 'cui_str': 'Phlorhizin'}, {'cui': 'C3257517', 'cui_str': 'Apple extract'}, {'cui': 'C0038179', 'cui_str': 'Starch'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}, {'cui': 'C1998602', 'cui_str': 'Meals'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0006558', 'cui_str': 'C-peptide'}, {'cui': 'C0017132', 'cui_str': 'Gastric inhibitory polypeptide'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0031560', 'cui_str': 'Phloretin'}, {'cui': 'C0034392', 'cui_str': 'Quercetin'}, {'cui': 'C0014485', 'cui_str': '(-)-Epicatechin'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0427743', 'cui_str': 'Glucose concentration, test strip measurement'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0005528', 'cui_str': 'Biological transport'}]",,0.233603,"RESULTS


AE significantly reduced plasma glucose iAUC 0-30 min at all doses: mean differences (95% CI) relative to CON were-15.6 (-23.3, -7.9), -11.3 (-19.6, -3.0)","[{'ForeName': 'Emily J', 'Initials': 'EJ', 'LastName': 'Prpa', 'Affiliation': ""Department of Nutritional Sciences, Faculty of Life Sciences and Medicine, King's College London, Franklin-Wilkins Building, 150 Stamford Street, London, UK.""}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Corpe', 'Affiliation': ""Department of Nutritional Sciences, Faculty of Life Sciences and Medicine, King's College London, Franklin-Wilkins Building, 150 Stamford Street, London, UK.""}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Atkinson', 'Affiliation': ""Department of Nutritional Sciences, Faculty of Life Sciences and Medicine, King's College London, Franklin-Wilkins Building, 150 Stamford Street, London, UK.""}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'Blackstone', 'Affiliation': ""Department of Nutritional Sciences, Faculty of Life Sciences and Medicine, King's College London, Franklin-Wilkins Building, 150 Stamford Street, London, UK.""}, {'ForeName': 'Elizabeth S', 'Initials': 'ES', 'LastName': 'Leftley', 'Affiliation': ""Department of Nutritional Sciences, Faculty of Life Sciences and Medicine, King's College London, Franklin-Wilkins Building, 150 Stamford Street, London, UK.""}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Parekh', 'Affiliation': ""Department of Nutritional Sciences, Faculty of Life Sciences and Medicine, King's College London, Franklin-Wilkins Building, 150 Stamford Street, London, UK.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Philo', 'Affiliation': 'Quadram Institute Bioscience, Norwich Research Park, Norwich, UK.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Kroon', 'Affiliation': 'Quadram Institute Bioscience, Norwich Research Park, Norwich, UK.'}, {'ForeName': 'Wendy L', 'Initials': 'WL', 'LastName': 'Hall', 'Affiliation': ""Department of Nutritional Sciences, Faculty of Life Sciences and Medicine, King's College London, Franklin-Wilkins Building, 150 Stamford Street, London, UK. Electronic address: wendy.hall@kcl.ac.uk.""}]",The Journal of nutritional biochemistry,['10.1016/j.jnutbio.2020.108466']
2375,32751446,Effect of an Integrated Healthcare Program for Korean Rural Older Adults: A Quasi-Experimental Study.,"Studies have been conducted on the development of healthcare programs for older adults in rural areas, not only in Asia but also in Europe and the United States. However, these reports have been limited by largely non-comprehensive results, lack of demand surveys, or programs with no systematic development. The purpose of this study was to develop an integrated healthcare program for rural older adults and investigate the effects of the program. A nonequivalent control group pretest-posttest design was used. Subjects were aged over 65 and lived in the rural community. The integrated healthcare program involved 12 three-hour sessions over 12 weeks. Compared with the control group, the experimental group demonstrated significant differences in both upper extremities strengths (t = 2.74,  p  = 0.008; t = 2.03,  p  = 0.047), static balance (z = -2.38,  p  = 0.017), dynamic balance (t = -4.82,  p  < 0.001), loneliness (t = -3.02,  p  = 0.003), and role self-efficacy (t = 2.39,  p  = 0.020), but no differences for ego integration (t = 1.51,  p  = 0.137). To improve physical, mental, and social health of the rural older adults, we developed an integrated healthcare program. The program improved physical functions, loneliness, and role self-efficiency of the rural older adults. Therefore, it is recommended that healthcare professionals actively apply this program in primary healthcare institutes and elsewhere.",2020,"Compared with the control group, the experimental group demonstrated significant differences in both upper extremities strengths (t = 2.74,  p  = 0.008; t = 2.03,  p  = 0.047), static balance","['rural older adults', 'older adults in rural areas', 'Korean Rural Older Adults', 'Subjects were aged over 65 and lived in the rural community']","['Integrated Healthcare Program', 'integrated healthcare program']","['static balance', 'physical, mental, and social health', 'physical functions, loneliness, and role self-efficiency', 'loneliness', 'upper extremities strengths', 'role self-efficacy', 'dynamic balance']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0086944', 'cui_str': 'Rural Communities'}]","[{'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}]",,0.0155838,"Compared with the control group, the experimental group demonstrated significant differences in both upper extremities strengths (t = 2.74,  p  = 0.008; t = 2.03,  p  = 0.047), static balance","[{'ForeName': 'Hyuk Joon', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Research Institute of Nursing Science, College of Nursing, Jeonbuk National University, Jeonju 54896, Korea.'}, {'ForeName': 'Hye Young', 'Initials': 'HY', 'LastName': 'Kim', 'Affiliation': 'Research Institute of Nursing Science, College of Nursing, Jeonbuk National University, Jeonju 54896, Korea.'}, {'ForeName': 'Youngran', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Research Institute of Nursing Science, College of Nursing, Jeonbuk National University, Jeonju 54896, Korea.'}, {'ForeName': 'Eun', 'Initials': 'E', 'LastName': 'Ko', 'Affiliation': 'Department of Nursing, College of Life Science and Natural Resources, Sunchon National University, Suncheon 57922, Korea.'}]","Healthcare (Basel, Switzerland)",['10.3390/healthcare8030244']
2376,32738573,"Effect of multispecies probiotic on gut microbiota composition in individuals with intestinal constipation: A double-blind, placebo-controlled randomized trial.","OBJECTIVE


The aim of this study was to evaluate the effect of a multispecies probiotic on gut microbiota composition and constipation symptoms.
METHODS


A randomized, double-blind, placebo-controlled clinical trial was conducted with 35 individuals with constipation for 30 days. The individuals were randomized into two groups: the control capsule (CC) and the probiotic capsule (PC) groups. Constipation symptoms were evaluated by the ROME IV criteria and by evacuation diaries. Fecal microbiota was analyzed by 16 S rRNA gene sequencing.
RESULTS


The majority of participants were women (85.7%). There was a significant reduction in the percent of participants who had incomplete defecation (P = 0.034), blockage sensation (P = 0.025), and rarely present liquid stools without the aid of laxatives (P = 0.046) only within the PC group (but no significant difference between groups). There was a significant increase in the relative abundance percentage of Blautia faecis and Ruminococcus torques in the CC group (P = 0.003 and P = 0.011, respectively), although there was no significant change in the PC group (P = 0.794 and P = 0.958, respectively), with a significant difference between groups (P = 0.029 and P 0.013, respectively), suggesting that probiotic treatment prevented the increase of percent relative abundance of these two species.
CONCLUSION


These results suggest that multispecies probiotics in capsule form may modulate gut microbiota by reducing the bacteria that are commonly increased in patients with constipation, contributing to the balance of microbiota and, consequently, to the well-being of the individual. Future studies with larger numbers of patients are required.",2020,"There was a significant reduction in the percent of participants who had incomplete defecation (P = 0.034), blockage sensation (P = 0.025), and rarely present liquid stools without the aid of laxatives (P = 0.046) only within the PC group (but no significant difference between groups).","['individuals with intestinal constipation', '35 individuals with constipation for 30 days', 'patients with constipation']","['control capsule (CC) and the probiotic capsule (PC', 'multispecies probiotic', 'placebo']","['incomplete defecation', 'gut microbiota composition and constipation symptoms', 'Constipation symptoms', 'blockage sensation', 'Fecal microbiota', 'gut microbiota composition', 'relative abundance percentage of Blautia faecis and Ruminococcus torques']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C2658870', 'cui_str': 'Blautia'}, {'cui': 'C0318074', 'cui_str': 'Ruminococcus'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}]",35.0,0.289849,"There was a significant reduction in the percent of participants who had incomplete defecation (P = 0.034), blockage sensation (P = 0.025), and rarely present liquid stools without the aid of laxatives (P = 0.046) only within the PC group (but no significant difference between groups).","[{'ForeName': 'Patrícia Borges', 'Initials': 'PB', 'LastName': 'Botelho', 'Affiliation': 'Department of Nutrition, Faculty of Health Sciences, University of Brasília, Brasília, Brazil. Electronic address: patriciabotelho@unb.br.'}, {'ForeName': 'Marcus Vinícius Rodrigues', 'Initials': 'MVR', 'LastName': 'Ferreira', 'Affiliation': 'Department of Nutrition, Faculty of Health Sciences, University of Brasília, Brasília, Brazil.'}, {'ForeName': 'Ananda de Mesquita', 'Initials': 'AM', 'LastName': 'Araújo', 'Affiliation': 'Department of Nutrition, Faculty of Health Sciences, University of Brasília, Brasília, Brazil.'}, {'ForeName': 'Marcela Moraes', 'Initials': 'MM', 'LastName': 'Mendes', 'Affiliation': 'Department of Nutrition, Faculty of Health Sciences, University of Brasília, Brasília, Brazil.'}, {'ForeName': 'Eduardo Yoshio', 'Initials': 'EY', 'LastName': 'Nakano', 'Affiliation': 'Statistics Department, University of Brasilia, Brasília, Brazil.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2020.110890']
2377,32738599,Tumor infiltrating lymphocytes after neoadjuvant IRX-2 immunotherapy in oral squamous cell carcinoma: Interim findings from the INSPIRE trial.,"OBJECTIVES


IRX-2 is a primary-cell-derived immune-restorative consisting of multiple human cytokines that act to overcome tumor-mediated immunosuppression and provide an in vivo tumor vaccination to increase tumor infiltrating lymphocytes (TILs). A randomized phase II trial was conducted of the IRX regimen 3 weeks prior to surgery consisting of an initial dose of cyclophosphamide followed by 10 days of regional perilymphatic IRX-2 cytokine injections and daily oral indomethacin, zinc and omeprazole (Regimen 1) compared to the identical regimen without IRX-2 cytokines (Regimen 2).
METHODS


A total of 96 patients with previously untreated, stage II-IV oral cavity SCC were randomized 2:1 to experimental (1) or control (2) regimens (64:32). Paired biopsy and resection specimens from 62 patients were available for creation of tissue microarray (n = 39), and multiplex immunohistology (n = 54). Increases in CD8+ TIL infiltrate scores of at least 10 cells/mm 2  were used to characterize immune responders (IR).
RESULTS


Regimen 1 was associated with significant increases in CD8+ infiltrates (p = 0.01) compared to Regimen 2. In p16 negative cancers (n = 26), significant increases in CD8+ and overall TILs were evident in Regimen 1 (p = 0.004, and 0.04 respectively). IRs were more frequent in Regimen 1 (74% vs 31%, p = 0.01). Multiplex immunohistology for PD-L1 expression confirmed an increase in PD-L1 H score for Regimen 1 compared to Regimen 2 (p = 0.11).
CONCLUSIONS


The findings demonstrate significant increases in TILs after perilymphatic IRX-2 injections. Three quarters of patients showed significant immune responses to IRX-2. (NCT02609386).",2020,"RESULTS


Regimen 1 was associated with significant increases in CD8+ infiltrates (p = 0.01) compared to Regimen 2.","['96 patients with previously untreated, stage II-IV oral cavity SCC', 'oral squamous cell carcinoma']","['indomethacin, zinc and omeprazole', 'cyclophosphamide', 'neoadjuvant IRX-2 immunotherapy']","['PD-L1 H score', 'CD8+ TIL infiltrate scores', 'CD8+ infiltrates', 'CD8+ and overall TILs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0585362', 'cui_str': 'Squamous cell carcinoma of mouth'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0007137', 'cui_str': 'Squamous cell carcinoma'}]","[{'cui': 'C0021246', 'cui_str': 'Indomethacin'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0028978', 'cui_str': 'Omeprazole'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0758290', 'cui_str': 'IRX 2'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}]","[{'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C0079722', 'cui_str': 'Tumor-Infiltrating Lymphocytes'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",96.0,0.0184539,"RESULTS


Regimen 1 was associated with significant increases in CD8+ infiltrates (p = 0.01) compared to Regimen 2.","[{'ForeName': 'Gregory T', 'Initials': 'GT', 'LastName': 'Wolf', 'Affiliation': 'Michigan Medicine, University of Michigan, Ann Arbor, MI 48109, United States. Electronic address: gregwolf@umich.edu.'}, {'ForeName': 'Siyu', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Michigan Medicine, University of Michigan, Ann Arbor, MI 48109, United States.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Bellile', 'Affiliation': 'Michigan Medicine, University of Michigan, Ann Arbor, MI 48109, United States.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Sartor', 'Affiliation': 'Michigan Medicine, University of Michigan, Ann Arbor, MI 48109, United States.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Rozek', 'Affiliation': 'Michigan Medicine, University of Michigan, Ann Arbor, MI 48109, United States.'}, {'ForeName': 'Dafydd', 'Initials': 'D', 'LastName': 'Thomas', 'Affiliation': 'Michigan Medicine, University of Michigan, Ann Arbor, MI 48109, United States.'}, {'ForeName': 'Ariane', 'Initials': 'A', 'LastName': 'Nguyen', 'Affiliation': 'Michigan Medicine, University of Michigan, Ann Arbor, MI 48109, United States.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Zarins', 'Affiliation': 'Michigan Medicine, University of Michigan, Ann Arbor, MI 48109, United States.'}, {'ForeName': 'Jonathan B', 'Initials': 'JB', 'LastName': 'McHugh', 'Affiliation': 'Michigan Medicine, University of Michigan, Ann Arbor, MI 48109, United States.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Oral oncology,['10.1016/j.oraloncology.2020.104928']
2378,32748345,Advanced Notification Calls Prior to Mailed Fecal Immunochemical Test in Previously Screened Patients: a Randomized Controlled Trial.,"BACKGROUND


Phone calls as part of multimodal fecal immunochemical test (FIT) outreach are effective but resource-intensive. Previous studies of advanced notification calls before FIT mailing have not differentiated patients' prior screening status.
OBJECTIVE


To determine the effectiveness of a phone call preceding mailing of a FIT kit on test completion rate for patients who have completed a prior FIT.
DESIGN


Randomized controlled trial nested within a larger study. All patients were assigned to receive organized mailed FIT outreach in the larger study.
PARTICIPANTS


Patients in a safety-net health setting ages 50-75 years old with a previously negative FIT.
INTERVENTIONS


Patients were assigned to either receive an advanced notification phone call or no phone call preceding a mailed FIT kit. Both groups received an informational postcard prior to the mailed FIT.
MAIN MEASURES


The primary outcome was FIT completion rate at 1 year. The secondary outcomes were FIT completion rates at 60, 90, and 180 days, rates stratified by demographic subgroups, and rates according to outcome of the phone call.
KEY RESULTS


A total of 1645 patients were assigned to advanced notification calls and 1595 were assigned to no call preceding the FIT mailing. Although FIT completion rate was higher at day 60 (55.5% vs. 50.8%, p < 0.01), an advanced notification call did not significantly improve FIT completion at 1 year (70.9% vs. 69.9%, p = 0.52). Of the patients assigned to receive an advanced notification call, 90.5% were spoken with or left a voicemail; patients who were spoken with were more likely to complete a FIT at 1 year compared with patients who were only left a voicemail or could not be left a voicemail (79.9% vs. 69.2% vs. 49.6%, p < 0.01).
CONCLUSIONS


Advanced notification phone calls prior to FIT mailing did not improve rates at 1 year for patients with a previously negative FIT.",2020,"Although FIT completion rate was higher at day 60 (55.5% vs. 50.8%, p < 0.01), an advanced notification call did not significantly improve FIT completion at 1 year (70.9% vs. 69.9%, p = 0.52).","['patients who have completed a prior FIT', 'Previously Screened Patients', '1645 patients were assigned to advanced notification calls and 1595 were assigned to no call preceding the FIT mailing', 'Patients in a safety-net health setting ages 50-75 years old with a previously negative FIT']","['advanced notification phone call or no phone call preceding a mailed FIT kit', 'informational postcard prior to the mailed FIT', 'phone call preceding mailing of a FIT kit', 'organized mailed FIT outreach']","['FIT completion rate at 1 year', 'FIT completion rates', 'FIT completion', 'FIT completion rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0422202', 'cui_str': 'Notifications'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205160', 'cui_str': 'Negative'}]","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0422202', 'cui_str': 'Notifications'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C1272835', 'cui_str': 'Test kit'}, {'cui': 'C2717852', 'cui_str': 'Postcards'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1300196', 'cui_str': 'Organized'}]","[{'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439234', 'cui_str': 'year'}]",1645.0,0.113703,"Although FIT completion rate was higher at day 60 (55.5% vs. 50.8%, p < 0.01), an advanced notification call did not significantly improve FIT completion at 1 year (70.9% vs. 69.9%, p = 0.52).","[{'ForeName': 'Briton', 'Initials': 'B', 'LastName': 'Lee', 'Affiliation': 'School of Medicine, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Shreya', 'Initials': 'S', 'LastName': 'Patel', 'Affiliation': 'Division of Gastroenterology, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Carly', 'Initials': 'C', 'LastName': 'Rachocki', 'Affiliation': 'Division of Gastroenterology, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Issaka', 'Affiliation': 'Clinical Research & Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Vittinghoff', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Jean A', 'Initials': 'JA', 'LastName': 'Shapiro', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Uri', 'Initials': 'U', 'LastName': 'Ladabaum', 'Affiliation': 'Division of Gastroenterology, Stanford University, Palo Alto, CA, USA.'}, {'ForeName': 'Ma', 'Initials': 'M', 'LastName': 'Somsouk', 'Affiliation': 'Division of Gastroenterology, University of California San Francisco, San Francisco, CA, USA. Ma.somsouk@ucsf.edu.'}]",Journal of general internal medicine,['10.1007/s11606-020-06009-4']
2379,32753637,Effects of L-theanine-caffeine combination on sustained attention and inhibitory control among children with ADHD: a proof-of-concept neuroimaging RCT.,"We examined the acute effects of L-theanine, caffeine and their combination on sustained attention, inhibitory control and overall cognition in boys with attention deficit hyperactivity disorder (ADHD). L-Theanine (2.5 mg/kg), caffeine (2.0 mg/kg), their combination and a placebo were administered in a randomized four-way repeated-measures crossover with washout, to five boys (8-15 years) with ADHD. Functional magnetic resonance imaging (fMRI) was performed during a Go/NoGo task and a Stop-signal task ~ 1 h post-dose. NIH Cognition Toolbox was administered ~ 2 h post-dose. Treatment vs. placebo effects were examined in multi-level mixed-effects models. L-Theanine improved total cognition composite in NIH Cognition Toolbox (p = 0.040) vs. placebo. Caffeine worsened and L-theanine had a trend of worsening inhibitory control (i.e. increased Stop-signal reaction time; p = 0.031 and p = 0.053 respectively). L-Theanine-caffeine combination improved total cognition composite (p = 0.041), d-prime in the Go/NoGo task (p = 0.033) and showed a trend of improvement of inhibitory control (p = 0.080). L-Theanine-caffeine combination was associated with decreased task-related reactivity of a brain network associated with mind wandering (i.e. default mode network). L-Theanine-caffeine combination may be a potential therapeutic option for ADHD-associated impairments in sustained attention, inhibitory control and overall cognitive performance.",2020,L-Theanine improved total cognition composite in NIH Cognition Toolbox (p = 0.040) vs. placebo.,"['children with ADHD', 'boys with attention deficit hyperactivity disorder (ADHD']","['L-Theanine-caffeine combination', 'L-Theanine-caffeine', 'caffeine', 'Caffeine', 'L-Theanine', 'Functional magnetic resonance imaging (fMRI', 'L-theanine-caffeine combination', 'L-theanine, caffeine and their combination', 'placebo']","['worsening inhibitory control', 'total cognition composite', 'total cognition composite in NIH Cognition Toolbox', 'sustained attention and inhibitory control']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0870221', 'cui_str': 'Male child'}]","[{'cui': 'C0076380', 'cui_str': 'theanine'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0027468', 'cui_str': 'United States National Institutes of Health'}, {'cui': 'C0589099', 'cui_str': 'Sustained attention'}]",,0.0661708,L-Theanine improved total cognition composite in NIH Cognition Toolbox (p = 0.040) vs. placebo.,"[{'ForeName': 'Chanaka N', 'Initials': 'CN', 'LastName': 'Kahathuduwa', 'Affiliation': 'Department of Laboratory Sciences and Primary Care, School of Health Professions, Texas Tech University Health Sciences Center, 3601 4th Street, Lubbock, TX, USA. chanaka.kahathuduwa@ttuhsc.edu.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Wakefield', 'Affiliation': 'Department of Psychiatry, School of Medicine, Texas Tech University Health Sciences Center, 3601 4th Street, Lubbock, TX, USA.'}, {'ForeName': 'Blake D', 'Initials': 'BD', 'LastName': 'West', 'Affiliation': 'Department of Human Development and Family Studies, College of Human Sciences, Texas Tech University, Lubbock, TX, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Blume', 'Affiliation': 'Department of Human Development and Family Studies, College of Human Sciences, Texas Tech University, Lubbock, TX, USA.'}, {'ForeName': 'Tharaka L', 'Initials': 'TL', 'LastName': 'Dassanayake', 'Affiliation': 'Department of Physiology, Faculty of Medicine, University of Peradeniya, Peradeniya, Sri Lanka.'}, {'ForeName': 'Vajira S', 'Initials': 'VS', 'LastName': 'Weerasinghe', 'Affiliation': 'Department of Physiology, Faculty of Medicine, University of Peradeniya, Peradeniya, Sri Lanka.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Mastergeorge', 'Affiliation': 'Department of Human Development and Family Studies, College of Human Sciences, Texas Tech University, Lubbock, TX, USA.'}]",Scientific reports,['10.1038/s41598-020-70037-7']
2380,32753750,Transcriptomic profile of adverse neurodevelopmental outcomes after neonatal encephalopathy.,"A rapid and early diagnostic test to identify the encephalopathic babies at risk of adverse outcome may accelerate the development of neuroprotectants. We examined if a whole blood transcriptomic signature measured soon after birth, predicts adverse neurodevelopmental outcome eighteen months after neonatal encephalopathy. We performed next generation sequencing on whole blood ribonucleic acid obtained within six hours of birth from the first 47 encephalopathic babies recruited to the Hypothermia for Encephalopathy in Low and middle-income countries (HELIX) trial. Two infants with blood culture positive sepsis were excluded, and the data from remaining 45 were analysed. A total of 855 genes were significantly differentially expressed between the good and adverse outcome groups, of which RGS1 and SMC4 were the most significant. Biological pathway analysis adjusted for gender, trial randomisation allocation (cooling therapy versus usual care) and estimated blood leukocyte proportions revealed over-representation of genes from pathways related to melatonin and polo-like kinase in babies with adverse outcome. These preliminary data suggest that transcriptomic profiling may be a promising tool for rapid risk stratification in neonatal encephalopathy. It may provide insights into biological mechanisms and identify novel therapeutic targets for neuroprotection.",2020,"A total of 855 genes were significantly differentially expressed between the good and adverse outcome groups, of which RGS1 and SMC4 were the most significant.","['Two infants with blood culture positive sepsis', 'neonatal encephalopathy', '47 encephalopathic babies recruited to the Hypothermia for Encephalopathy in Low and middle-income countries (HELIX) trial']",[],[],"[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0740299', 'cui_str': 'Blood culture positive for microorganism'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0235820', 'cui_str': 'Neonatal encephalopathy'}, {'cui': 'C0020672', 'cui_str': 'Hypothermia'}, {'cui': 'C0085584', 'cui_str': 'Encephalopathy'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],[],2.0,0.128731,"A total of 855 genes were significantly differentially expressed between the good and adverse outcome groups, of which RGS1 and SMC4 were the most significant.","[{'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Montaldo', 'Affiliation': 'Department of Brain Sciences, Centre for Perinatal Neuroscience, Imperial College London, London, UK. p.montaldo@imperial.ac.uk.'}, {'ForeName': 'Aubrey', 'Initials': 'A', 'LastName': 'Cunnington', 'Affiliation': 'Paediatric Infectious Diseases, Department of Infectious Diseases, Imperial College London, London, UK.'}, {'ForeName': 'Vania', 'Initials': 'V', 'LastName': 'Oliveira', 'Affiliation': 'Department of Brain Sciences, Centre for Perinatal Neuroscience, Imperial College London, London, UK.'}, {'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Swamy', 'Affiliation': 'Department of Brain Sciences, Centre for Perinatal Neuroscience, Imperial College London, London, UK.'}, {'ForeName': 'Prathik', 'Initials': 'P', 'LastName': 'Bandya', 'Affiliation': 'Neonatal Medicine, Indira Gandhi Institute of Child Health, Bangalore, Karnataka, India.'}, {'ForeName': 'Stuti', 'Initials': 'S', 'LastName': 'Pant', 'Affiliation': 'Department of Brain Sciences, Centre for Perinatal Neuroscience, Imperial College London, London, UK.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Lally', 'Affiliation': 'Department of Brain Sciences, Centre for Perinatal Neuroscience, Imperial College London, London, UK.'}, {'ForeName': 'Phoebe', 'Initials': 'P', 'LastName': 'Ivain', 'Affiliation': 'Department of Brain Sciences, Centre for Perinatal Neuroscience, Imperial College London, London, UK.'}, {'ForeName': 'Josephine', 'Initials': 'J', 'LastName': 'Mendoza', 'Affiliation': 'Department of Brain Sciences, Centre for Perinatal Neuroscience, Imperial College London, London, UK.'}, {'ForeName': 'Gaurav', 'Initials': 'G', 'LastName': 'Atreja', 'Affiliation': 'Department of Brain Sciences, Centre for Perinatal Neuroscience, Imperial College London, London, UK.'}, {'ForeName': 'Vadakepat', 'Initials': 'V', 'LastName': 'Padmesh', 'Affiliation': 'Neonatal Medicine, Institute of Obstetrics and Gynaecology, Madras Medical College, Chennai, Tamil Nadu, India.'}, {'ForeName': 'Mythili', 'Initials': 'M', 'LastName': 'Baburaj', 'Affiliation': 'Neonatal Medicine, Institute of Obstetrics and Gynaecology, Madras Medical College, Chennai, Tamil Nadu, India.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Sebastian', 'Affiliation': 'Neonatal Medicine, Institute of Child Health, Madras Medical College, Tamil Nadu, Chennai, India.'}, {'ForeName': 'Indiramma', 'Initials': 'I', 'LastName': 'Yasashwi', 'Affiliation': 'Neonatal Medicine, Indira Gandhi Institute of Child Health, Bangalore, Karnataka, India.'}, {'ForeName': 'Chinnathambi', 'Initials': 'C', 'LastName': 'Kamalarathnam', 'Affiliation': 'Neonatal Medicine, Institute of Obstetrics and Gynaecology, Madras Medical College, Chennai, Tamil Nadu, India.'}, {'ForeName': 'Rema', 'Initials': 'R', 'LastName': 'Chandramohan', 'Affiliation': 'Neonatal Medicine, Institute of Obstetrics and Gynaecology, Madras Medical College, Chennai, Tamil Nadu, India.'}, {'ForeName': 'Sundaram', 'Initials': 'S', 'LastName': 'Mangalabharathi', 'Affiliation': 'Neonatal Medicine, Institute of Obstetrics and Gynaecology, Madras Medical College, Chennai, Tamil Nadu, India.'}, {'ForeName': 'Kumutha', 'Initials': 'K', 'LastName': 'Kumaraswami', 'Affiliation': 'Neonatal Medicine, Institute of Obstetrics and Gynaecology, Madras Medical College, Chennai, Tamil Nadu, India.'}, {'ForeName': 'Shobha', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': 'Neonatal Medicine, Institute of Obstetrics and Gynaecology, Madras Medical College, Chennai, Tamil Nadu, India.'}, {'ForeName': 'Naveen', 'Initials': 'N', 'LastName': 'Benakappa', 'Affiliation': 'Neonatal Medicine, Indira Gandhi Institute of Child Health, Bangalore, Karnataka, India.'}, {'ForeName': 'Swati', 'Initials': 'S', 'LastName': 'Manerkar', 'Affiliation': 'Neonatal Medicine, Sion Medical College, Mumbai, India.'}, {'ForeName': 'Jayashree', 'Initials': 'J', 'LastName': 'Mondhkar', 'Affiliation': 'Neonatal Medicine, Sion Medical College, Mumbai, India.'}, {'ForeName': 'Vinayagam', 'Initials': 'V', 'LastName': 'Prakash', 'Affiliation': 'Neonatal Medicine, Institute of Obstetrics and Gynaecology, Madras Medical College, Chennai, Tamil Nadu, India.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Sajjid', 'Affiliation': 'Neonatal Medicine, Institute of Obstetrics and Gynaecology, Madras Medical College, Chennai, Tamil Nadu, India.'}, {'ForeName': 'Arasar', 'Initials': 'A', 'LastName': 'Seeralar', 'Affiliation': 'Neonatal Medicine, Institute of Child Health, Madras Medical College, Tamil Nadu, Chennai, India.'}, {'ForeName': 'Ismat', 'Initials': 'I', 'LastName': 'Jahan', 'Affiliation': 'Neonatal Medicine, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh.'}, {'ForeName': 'Sadeka Choudhury', 'Initials': 'SC', 'LastName': 'Moni', 'Affiliation': 'Neonatal Medicine, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh.'}, {'ForeName': 'Mohammod', 'Initials': 'M', 'LastName': 'Shahidullah', 'Affiliation': 'Neonatal Medicine, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh.'}, {'ForeName': 'Radhika', 'Initials': 'R', 'LastName': 'Sujatha', 'Affiliation': 'Neonatal Medicine, Government Medical College, Thiruvananthapuram, Kerala, India.'}, {'ForeName': 'Manigandan', 'Initials': 'M', 'LastName': 'Chandrasekaran', 'Affiliation': 'Department of Brain Sciences, Centre for Perinatal Neuroscience, Imperial College London, London, UK.'}, {'ForeName': 'Siddarth', 'Initials': 'S', 'LastName': 'Ramji', 'Affiliation': 'Neonatal Medicine, Maulana Azad Medical College, New Delhi, Delhi, India.'}, {'ForeName': 'Seetha', 'Initials': 'S', 'LastName': 'Shankaran', 'Affiliation': 'Neonatal-Perinatal Medicine, Wayne State University, Detroit, MI, USA.'}, {'ForeName': 'Myrsini', 'Initials': 'M', 'LastName': 'Kaforou', 'Affiliation': 'Paediatric Infectious Diseases, Department of Infectious Diseases, Imperial College London, London, UK.'}, {'ForeName': 'Jethro', 'Initials': 'J', 'LastName': 'Herberg', 'Affiliation': 'Paediatric Infectious Diseases, Department of Infectious Diseases, Imperial College London, London, UK.'}, {'ForeName': 'Sudhin', 'Initials': 'S', 'LastName': 'Thayyil', 'Affiliation': 'Department of Brain Sciences, Centre for Perinatal Neuroscience, Imperial College London, London, UK.'}]",Scientific reports,['10.1038/s41598-020-70131-w']
2381,32739611,Changes in technology acceptance among older people with dementia: the role of social robot engagement.,"OBJECTIVE


Emerging technologies such as social robots have shown to be effective in reducing loneliness and agitation for older people with dementia. However, the acceptance of technology (specifically social robots) was found to be low for older people with dementia. The current understanding of changes in technology acceptance following direct exposure is limited and lacks rigorous study design. This study examined the change in technology acceptance after a direct interaction with a humanoid social robot (Kabochan) that was deployed for long-term care facilities' residents with dementia.
METHODS


The technology acceptance was assessed using randomised control trials for a time frame of 32 weeks. A total of 103 residents clinically diagnosed with dementia, with a mean age of 87.2 years (SD = 7.4), were recruited from seven long-term care facilities in Hong Kong and were randomly allocated to either Kabochan-engagement group or control group. Participants in the engagement group interacted with Kabochan in an individual, non-facilitated approach. The behavioural engagement with Kabochan was observed by care workers and recorded into constructive engagement and non-engagement. Questionnaire surveys were taken placed at pre- and post-exposure with Kabochan to measure attitudes and beliefs towards technology. The questionnaire was based on previous studies on technology acceptance and included attitudes towards technology, perceived usefulness, perceived ease of use, technology self-efficacy, technology anxiety, and facilitating conditions.
RESULTS


Perceived ease of use was improved at week 32 for participants who interacted with Kabochan (F = 4.239, p = 0.042) with a small effect (η p 2  = 0.043) in comparison to usual care group. Results further demonstrated that the magnitude of belief changes was related to the intensity of constructive behavioural engagement. Specifically, resident-robot behavioural engagement moderately improved attitudes towards technology (F = 11.62, p < 0.001, η p 2  = 0.11) and perceived usefulness (F = 5.75, p = 0.02, η p 2  = 0.06).
CONCLUSIONS


The study tentatively supports that exposure to Kabochan has potential for changing perceived ease of use but not for other beliefs and attitudes towards technology among long-term care residents with dementia. Direct engagement with a humanoid social robot might be promising in improving the perceived ease of use towards technology.",2020,"Perceived ease of use was improved at week 32 for participants who interacted with Kabochan (F = 4.239, p = 0.042) with a small effect (η p 2  = 0.043) in comparison to usual care group.","['103 residents clinically diagnosed with dementia, with a mean age of 87.2 years (SD = 7.4), were recruited from seven long-term care facilities in Hong Kong', ""long-term care facilities' residents with dementia"", 'older people with dementia']","['humanoid social robot (Kabochan', 'humanoid social robot', 'Kabochan-engagement group or control group', 'Kabochan']","['Perceived ease of use', 'attitudes towards technology']","[{'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517858', 'cui_str': '7.4'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]",103.0,0.0256322,"Perceived ease of use was improved at week 32 for participants who interacted with Kabochan (F = 4.239, p = 0.042) with a small effect (η p 2  = 0.043) in comparison to usual care group.","[{'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Ke', 'Affiliation': 'Sau Po Centre on Ageing, the University of Hong Kong, Hong Kong. Electronic address: kechen@hku.hk.'}, {'ForeName': 'Vivian Wei-Qun', 'Initials': 'VW', 'LastName': 'Lou', 'Affiliation': 'Sau Po Centre on Ageing, the University of Hong Kong, Hong Kong; Social Work and Social Administration, the University of Hong Kong, Pok Fu Lam, Hong Kong. Electronic address: wlou@hku.hk.'}, {'ForeName': 'Kelvin Cheng-Kian', 'Initials': 'KC', 'LastName': 'Tan', 'Affiliation': 'Social Work and Social Administration, the University of Hong Kong, Pok Fu Lam, Hong Kong. Electronic address: u3004055@connect.hku.hk.'}, {'ForeName': 'Man Yi', 'Initials': 'MY', 'LastName': 'Wai', 'Affiliation': 'Hong Kong Sheng Kung Hui Welfare Council Ltd, Hong Kong. Electronic address: gwai@skhwc.org.hk.'}, {'ForeName': 'Lai Lok', 'Initials': 'LL', 'LastName': 'Chan', 'Affiliation': 'Hong Kong Sheng Kung Hui Welfare Council Ltd, Hong Kong. Electronic address: llchan@skhwc.org.hk.'}]",International journal of medical informatics,['10.1016/j.ijmedinf.2020.104241']
2382,32755802,Distance to white matter trajectories is associated with treatment response to internal capsule deep brain stimulation in treatment-refractory depression.,"BACKGROUND


Deep brain stimulation (DBS) is an innovative treatment for treatment-refractory depression. DBS is usually targeted at specific anatomical landmarks, with patients responding to DBS in approximately 50% of cases. Attention has recently shifted to white matter tracts to explain DBS response, with initial open-label trials targeting white matter tracts yielding much higher response rates (>70%).
OBJECTIVE/HYPOTHESIS


Our aim was to associate distance to individual white matter tracts around the stimulation target in the ventral anterior limb of the internal capsule to treatment response.
METHODS


We performed diffusion magnetic resonance tractography of the superolateral branch of the medial forebrain bundle and the anterior thalamic radiation in fourteen patients that participated in our randomized clinical trial. We combined the tract reconstructions with the postoperative images to identify the DBS leads and estimated the distance between tracts and leads, which we subsequently associated with treatment response.
RESULTS


Stimulation closer to both tracts was significantly correlated to a larger symptom decrease (r = 0.61, p = 0.02), suggesting that stimulation more proximal to the tracts was beneficial. Biophysical modelling indicated that 37.5% of tracts were even outside the volume of activated tissue. There was no difference in lead placement with respect to anatomical landmarks, which could mean that differences in treatment response were driven by individual differences in white matter anatomy.
CONCLUSIONS


Our results suggest that deep brain stimulation of the ventral anterior limb of the internal capsule could benefit from targeting white matter bundles. We recommend acquiring diffusion magnetic resonance data for each individual patient.",2020,"RESULTS


Stimulation closer to both tracts was significantly correlated to a larger symptom decrease (r = 0.61, p = 0.02), suggesting that stimulation more proximal to the tracts was beneficial.",['fourteen patients that participated in our randomized clinical trial'],"['DBS', 'Deep brain stimulation (DBS', 'diffusion magnetic resonance tractography of the superolateral branch of the medial forebrain bundle and the anterior thalamic radiation']",['lead placement'],"[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206034', 'cui_str': 'Trials, Randomized Clinical'}]","[{'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}, {'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C1253959', 'cui_str': 'Branch of'}, {'cui': 'C0025055', 'cui_str': 'Structure of median forebrain bundle'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0039729', 'cui_str': 'Thalamic structure'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}]","[{'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]",,0.085274,"RESULTS


Stimulation closer to both tracts was significantly correlated to a larger symptom decrease (r = 0.61, p = 0.02), suggesting that stimulation more proximal to the tracts was beneficial.","[{'ForeName': 'Luka C', 'Initials': 'LC', 'LastName': 'Liebrand', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Psychiatry, Amsterdam Neuroscience, Meibergdreef 9, Amsterdam, Netherlands; Amsterdam UMC, University of Amsterdam, Department of Biomedical Engineering and Physics, Meibergdreef 9, Amsterdam, Netherlands; Amsterdam Brain and Cognition, Nieuwe Achtergracht 129 B, Amsterdam, Netherlands. Electronic address: L.C.Liebrand@amsterdamumc.nl.'}, {'ForeName': 'Samuel J', 'Initials': 'SJ', 'LastName': 'Natarajan', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Psychiatry, Amsterdam Neuroscience, Meibergdreef 9, Amsterdam, Netherlands; Amsterdam Brain and Cognition, Nieuwe Achtergracht 129 B, Amsterdam, Netherlands.'}, {'ForeName': 'Matthan W A', 'Initials': 'MWA', 'LastName': 'Caan', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Biomedical Engineering and Physics, Meibergdreef 9, Amsterdam, Netherlands.'}, {'ForeName': 'P Richard', 'Initials': 'PR', 'LastName': 'Schuurman', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Neurosurgery, Meibergdreef 9, Amsterdam, Netherlands.'}, {'ForeName': 'Pepijn', 'Initials': 'P', 'LastName': 'van den Munckhof', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Neurosurgery, Meibergdreef 9, Amsterdam, Netherlands.'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'de Kwaasteniet', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Psychiatry, Amsterdam Neuroscience, Meibergdreef 9, Amsterdam, Netherlands; Amsterdam Brain and Cognition, Nieuwe Achtergracht 129 B, Amsterdam, Netherlands.'}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Luigjes', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Psychiatry, Amsterdam Neuroscience, Meibergdreef 9, Amsterdam, Netherlands; Amsterdam Brain and Cognition, Nieuwe Achtergracht 129 B, Amsterdam, Netherlands.'}, {'ForeName': 'Isidoor O', 'Initials': 'IO', 'LastName': 'Bergfeld', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Psychiatry, Amsterdam Neuroscience, Meibergdreef 9, Amsterdam, Netherlands; Amsterdam Brain and Cognition, Nieuwe Achtergracht 129 B, Amsterdam, Netherlands.'}, {'ForeName': 'Damiaan', 'Initials': 'D', 'LastName': 'Denys', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Psychiatry, Amsterdam Neuroscience, Meibergdreef 9, Amsterdam, Netherlands; Amsterdam Brain and Cognition, Nieuwe Achtergracht 129 B, Amsterdam, Netherlands; Netherlands Institute for Neuroscience, Royal Academy of Arts and Sciences, Meibergdreef 47, Amsterdam, Netherlands.'}, {'ForeName': 'Guido A', 'Initials': 'GA', 'LastName': 'van Wingen', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Psychiatry, Amsterdam Neuroscience, Meibergdreef 9, Amsterdam, Netherlands; Amsterdam Brain and Cognition, Nieuwe Achtergracht 129 B, Amsterdam, Netherlands.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2020.102363']
2383,32757626,Reply to 'Comments on Effectiveness of acupuncture vs. core stability training in balance and functional capacity of women with fibromyalgia: A randomized controlled trial'.,,2020,,['women with fibromyalgia'],['acupuncture vs. core stability training'],[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]",[],,0.287529,,"[{'ForeName': 'Elisa María', 'Initials': 'EM', 'LastName': 'Garrido-Ardila', 'Affiliation': 'ADOLOR Research group, Department of Medical-Surgical Therapy, Medicine Faculty, Physiotherapy Field, Extremadura University, Badajoz, Spain.'}]",Clinical rehabilitation,['10.1177/0269215520945656']
2384,32757628,"Comments on ""Effectiveness of acupuncture vs. core stability training in balance and functional capacity of women with fibromyalgia: a randomized controlled trial"".",,2020,,['women with fibromyalgia'],['acupuncture vs. core stability training'],[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]",[],,0.341993,,"[{'ForeName': 'Xiaoman', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Radiology, Third Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Pengfei', 'Initials': 'P', 'LastName': 'Rong', 'Affiliation': 'Department of Radiology, Third Xiangya Hospital, Central South University, Changsha, Hunan, China.'}]",Clinical rehabilitation,['10.1177/0269215520945663']
2385,32740807,Use of neoadjuvant versus adjuvant chemotherapy for hormone receptor-positive breast cancer: a National Cancer Database (NCDB) study.,"INTRODUCTION


Neoadjuvant chemotherapy (NAC) is a well-established therapeutic option for patients with locally advanced disease often allowing downstaging and facilitation of breast conserving therapy. With evolution of better targeted treatment regimens and awareness of improved outcomes for significant responders, use of NAC has expanded particularly for triple negative and HER2-positive (HER2+) breast cancer. In this study, we explore utility of neoadjuvant chemotherapy for hormone receptor-positive HER2-negative (HR+ HER2-) patients.
METHODS


Patients with HR+ HER2- breast cancer treated with chemotherapy before or after surgery were identified from 2010 to 2015 in the NCDB. Multivariable regression models adjusted for covariates were used to determine associations within these groups.
RESULTS


Among 134,574 patients (clinical stage 2A, 64%; 2B, 21%; 3, 15%), 105,324 (78%) had adjuvant chemotherapy (AC) and 29,250 (22%) received NAC. Use of NAC increased over time (2010-2015; 13.2-19.4% and PR = 1.34 for 2015; p < 0.0001). Patients were more likely to receive NAC with cT3, cT4, and cN+ disease. Patients less likely to receive NAC were age ≥ 50, lobular carcinoma, increased Charlson-Deyo score, and government insurance. Complete response (pCR) was noted in 8.3% of NAC patients. Axillary downstaging occurred in 21% of patients, and predictors included age < 50 years, black race, poorly differentiated grade, invasive ductal histology, and either ER or PR negativity.
CONCLUSIONS


NAC use among HR+ HER2- breast cancer patients has expanded over time and offers downstaging of disease for some patients, with pCR seen in only a small subset, but downstaging of the axilla in 21%. Further analysis is warranted to determine the subgroup of patients with HR+ HER2- disease who benefit from this approach.",2020,Use of NAC increased over time (2010-2015; 13.2-19.4% and PR = 1.34 for 2015; p < 0.0001).,"['Patients with HR+\u2009HER2- breast cancer treated with chemotherapy before or after surgery were identified from 2010 to 2015 in the NCDB', '134,574 patients (clinical stage 2A, 64%; 2B, 21%; 3, 15%), 105,324 (78%) had adjuvant chemotherapy (AC) and 29,250 (22%) received', 'HR+\u2009HER2- breast cancer patients', 'patients with locally advanced disease', 'hormone receptor-positive breast cancer']","['NAC', 'neoadjuvant versus adjuvant chemotherapy', 'Neoadjuvant chemotherapy (NAC', 'neoadjuvant chemotherapy']","['Complete response (pCR', 'Axillary downstaging']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0205563', 'cui_str': 'Clinical stage finding'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C1446409', 'cui_str': 'Positive'}]","[{'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}]","[{'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0004454', 'cui_str': 'Axillary'}]",134574.0,0.0330664,Use of NAC increased over time (2010-2015; 13.2-19.4% and PR = 1.34 for 2015; p < 0.0001).,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Zeidman', 'Affiliation': 'Mount Sinai Health System, New York, USA. mikezeidman@gmail.com.'}, {'ForeName': 'J Jaime', 'Initials': 'JJ', 'LastName': 'Alberty-Oller', 'Affiliation': 'Mount Sinai Health System, New York, USA.'}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Ru', 'Affiliation': 'Mount Sinai Health System, New York, USA.'}, {'ForeName': 'Kereeti V', 'Initials': 'KV', 'LastName': 'Pisapati', 'Affiliation': 'Mount Sinai Health System, New York, USA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Moshier', 'Affiliation': 'Mount Sinai Health System, New York, USA.'}, {'ForeName': 'Soojin', 'Initials': 'S', 'LastName': 'Ahn', 'Affiliation': 'Mount Sinai Health System, New York, USA.'}, {'ForeName': 'Madhu', 'Initials': 'M', 'LastName': 'Mazumdar', 'Affiliation': 'Mount Sinai Health System, New York, USA.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Port', 'Affiliation': 'Mount Sinai Health System, New York, USA.'}, {'ForeName': 'Hank', 'Initials': 'H', 'LastName': 'Schmidt', 'Affiliation': 'Mount Sinai Health System, New York, USA.'}]",Breast cancer research and treatment,['10.1007/s10549-020-05809-w']
2386,32745703,"Randomized controlled trial of the COPE-P intervention to improve mental health, healthy lifestyle behaviors, birth and post-natal outcomes of minority pregnant women: Study protocol with implications.","BACKGROUND


Emotionally distressed pregnant minority women experience multiple adverse outcomes, including pre-eclampsia, preterm birth, operative deliveries and low birth weight. Although the United States Preventive Services Task Force recommends screening in pregnant women, many practices do not screen because efficacious interventions and systems are not in place to treat them.
AIM


Purpose of this randomized controlled trial (RCT) is to test a group delivered manualized cognitive-behavioral skills building intervention entitled COPE-P versus an attention control program on the mental health, birth and postpartum outcomes of minority pregnant women experiencing depressive, anxiety and stress symptoms.
METHODS


Design is a longitudinal randomized block RCT with repeated measures (beginning with screening prior to 18 weeks, group prenatal care in both groups from 16 + 1 to 31 + 1 weeks and ending at 6 months postpartum) at two study sites (New York city and Columbus, Ohio). Race/ethnicity is being blocked to ensure equal numbers of Hispanic and Black women. 384 women are being recruited from antenatal clinics if they are: between 18 and 40 years; in an uncomplicated singleton pregnancy <18 weeks; and self-identify as Black or Hispanic. Valid and reliable measures are being used to assess healthy lifestyle behaviors and mental health outcomes immediately following the interventions, six - eight weeks postpartum and at the children's six-month well baby visit. Birth and delivery outcomes also are being assessed.
CONCLUSION


If found to be efficacious, the COPE-P intervention could be a key solution to managing those with emotional distress and improving their outcomes.",2020,"If found to be efficacious, the COPE-P intervention could be a key solution to managing those with emotional distress and improving their outcomes.","['minority pregnant women experiencing depressive, anxiety and stress symptoms', 'minority pregnant women', '384 women are being recruited from antenatal clinics if they are: between 18 and 40\u202fyears; in an uncomplicated singleton pregnancy <18\u202fweeks; and self-identify as Black or Hispanic', 'pregnant women']","['COPE-P intervention', 'COPE-P versus an attention control program']","['healthy lifestyle behaviors and mental health outcomes', 'mental health, healthy lifestyle behaviors, birth and post-natal outcomes']","[{'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0521991', 'cui_str': 'Symptoms of stress'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1274027', 'cui_str': 'Antenatal clinic'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}]","[{'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0454729', 'cui_str': 'Natal'}]",384.0,0.137281,"If found to be efficacious, the COPE-P intervention could be a key solution to managing those with emotional distress and improving their outcomes.","[{'ForeName': 'Bernadette Mazurek', 'Initials': 'BM', 'LastName': 'Melnyk', 'Affiliation': 'Health Promotion and Wellness, The Ohio State University, the Helene Fuld Health Trust National Institute for Evidence-based Practice in Nursing and Healthcare, College of Nursing, Pediatrics & Psychiatry, College of Medicine, The Ohio State University, 1585 Neil Ave, Columbus, OH 43210, United States of America. Electronic address: melnyk.15@osu.edu.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Gennaro', 'Affiliation': 'William F. Connell School of Nursing, Boston College, Chestnut Hill, MA, United States of America.'}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Szalacha', 'Affiliation': 'Research Methodology and Biostatistics Core, USF Health Morsani College of Medicine, College of Nursing, University of South Florida, United States of America.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Hoying', 'Affiliation': 'Consumer Core, the Helene Fuld Health Trust National Institute for Evidence-based Practice in Nursing and Healthcare, The Ohio State University College of Nursing, Columbus, OH, United States of America.'}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': ""O'Connor"", 'Affiliation': 'William F. Connell School of Nursing, Boston College, Chestnut Hill, MA, United States of America.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Cooper', 'Affiliation': 'The Ohio State University College of Nursing, Columbus, OH, United States of America.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Gibeau', 'Affiliation': 'Midwifery, Jacobi Medical Center, Bronx, NY, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106090']
2387,32751064,"Effects of Mulligan Mobilization and Low-Level Laser Therapy on Physical Disability, Pain, and Range of Motion in Patients with Chronic Low Back Pain: A Pilot Randomized Controlled Trial.","This study aimed to determine the combined treatment effects of Mulligan sustained natural apophyseal glides (SNAGs) and low-level laser therapy (LLLT) on function, pain, and range of motion (ROM) in patients with chronic low back pain. A total of 49 adults participated in this study and were randomly divided into three groups (SNAGs with LLLT group, SNAGs group, and control group). The participants in the SNAGs with LLLT group received SNAGs for 10 min, LLLT for 10 min, and electrotherapy for 10 min. The SNAGs group received SNAGs for 10 min and electrotherapy for 20 min. The control group received electrotherapy for 30 min. All participants received the assigned treatment for 30 min a day, 3 times a week, for 4 weeks. We used the visual analogue scale (VAS) to measure pain, the modified-modified Schober test (MMST) to measure ROM, and the Roland Morris disability questionnaire (RMDQ) to measure physical disability. Compared to the pre-intervention values, the VAS and MMST scores significantly increased after the intervention in the SNAGs with LLLT group ( p  = 0.000) and the SNAGs group ( p  = 0.000). The RMDQ score significantly improved in the SNAGs with LLLT ( p  = 0.000), SNAGs ( p  = 0.000) and control ( p  = 0.025) group after the intervention. The inter-group differences were greater for the SNAGs with LLLT and SNAGs groups than for the control group ( p  = 0.001), and the difference was greater for the SNAGs with LLLT than for the SNAGs ( p  = 0.001) with respect to the VAS, MMST, and RMDQ scores. These results indicate that significant improvement in pain, function, and ROM may be achieved by a combination of SNAGs and LLLT to treat chronic low back pain.",2020,"The RMDQ score significantly improved in the SNAGs with LLLT ( p  = 0.000), SNAGs ( p  = 0.000) and control ( p  = 0.025) group after the intervention.","['Patients with Chronic Low Back Pain', '49 adults', 'patients with chronic low back pain']","['Mulligan sustained natural apophyseal glides (SNAGs) and low-level laser therapy (LLLT', 'Mulligan Mobilization and Low-Level Laser Therapy', 'electrotherapy', 'LLLT']","['VAS, MMST, and RMDQ scores', 'pain, function, and ROM', 'VAS and MMST scores', 'function, pain, and range of motion (ROM', 'RMDQ score', 'visual analogue scale (VAS) to measure pain, the modified-modified Schober test (MMST) to measure ROM, and the Roland Morris disability questionnaire (RMDQ) to measure physical disability', 'Physical Disability, Pain, and Range of Motion']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0336966', 'cui_str': 'Gliding'}, {'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0013787', 'cui_str': 'Electrotherapy'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0430750', 'cui_str': 'Modified Schober test'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0520817', 'cui_str': 'Physical handicap'}]",49.0,0.0393352,"The RMDQ score significantly improved in the SNAGs with LLLT ( p  = 0.000), SNAGs ( p  = 0.000) and control ( p  = 0.025) group after the intervention.","[{'ForeName': 'U-Hyeok', 'Initials': 'UH', 'LastName': 'Seo', 'Affiliation': 'Graduate School of Physical Therapy, Sahmyook University, Seoul 01795, Korea.'}, {'ForeName': 'Jung-Hee', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Department of Physical Therapy, Andong Science College, Andong 36616, Korea.'}, {'ForeName': 'Byoung-Hee', 'Initials': 'BH', 'LastName': 'Lee', 'Affiliation': 'Department of Physical Therapy, Sahmyook University, Seoul 01795, Korea.'}]","Healthcare (Basel, Switzerland)",['10.3390/healthcare8030237']
2388,32757065,Effect of carbohydrate-protein supplementation on endurance training adaptations.,"PURPOSE


To examine the influence of post-exercise protein feeding upon the adaptive response to endurance exercise training.
METHODS


In a randomised parallel group design, 25 healthy men and women completed 6 weeks of endurance exercise training by running on a treadmill for 30-60 min at 70-75% maximal oxygen uptake (VO 2max ) 4 times/week. Participants ingested 1.6 g per kilogram of body mass (g kg BM -1 ) of carbohydrate (CHO) or an isocaloric carbohydrate-protein solution (CHO-P; 0.8 g carbohydrate kg BM -1  + 0.8 g protein kg BM -1 ) immediately and 1 h post-exercise. Expired gas, blood and muscle biopsy samples were taken at baseline and follow-up.
RESULTS


Exercise training improved VO 2max  in both groups (p ≤ 0.001), but this increment was not different between groups either in absolute terms or relative to body mass (0.2 ± 0.2 L min -1  and 3.0 ± 2 mL kg -1  min -1 , respectively). No change occurred in plasma albumin concentration from baseline to follow-up with CHO-P (4.18 ± 0.18 to 4.23 ± 0.17 g dL -1 ) or CHO (4.17 ± 0.17 to 4.12 ± 0.22 g dL -1 ; interaction: p > 0.05). Mechanistic target of rapamycin (mTOR) gene expression was up-regulated in CHO-P (+ 46%; p = 0.025) relative to CHO (+ 4%) following exercise training.
CONCLUSION


Post-exercise protein supplementation up-regulated the expression of mTOR in skeletal muscle over 6 weeks of endurance exercise training. However, the magnitude of improvement in VO 2max  was similar between groups.",2020,"RESULTS


Exercise training improved VO 2max  in both groups (p ≤ 0.001), but this increment was not different between groups either in absolute terms or relative to body mass (0.2 ± 0.2 ",['25 healthy men and women completed 6\xa0weeks of'],"['endurance exercise training by running on a treadmill for 30-60\xa0min at 70-75% maximal oxygen uptake', 'endurance exercise training', 'carbohydrate (CHO', 'carbohydrate-protein supplementation', 'isocaloric carbohydrate-protein solution (CHO-P; 0.8\xa0g carbohydrate kg', 'L']","['BM -1', 'plasma albumin concentration', 'VO 2max', 'Mechanistic target of rapamycin (mTOR) gene expression', 'endurance training adaptations', 'Expired gas, blood and muscle biopsy samples']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0419120', 'cui_str': 'Muscular endurance development exercise'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0054889', 'cui_str': 'CAV protocol'}, {'cui': 'C0770246', 'cui_str': 'Protein supplementation'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C4517481', 'cui_str': '0.8'}]","[{'cui': 'C0857876', 'cui_str': 'Plasma albumin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1307407', 'cui_str': 'FRAP1 protein, human'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0587033', 'cui_str': 'Muscle biopsy sample'}]",25.0,0.046735,"RESULTS


Exercise training improved VO 2max  in both groups (p ≤ 0.001), but this increment was not different between groups either in absolute terms or relative to body mass (0.2 ± 0.2 ","[{'ForeName': 'Abdullah F', 'Initials': 'AF', 'LastName': 'Alghannam', 'Affiliation': 'Lifestyle and Health Research Center, Health Sciences Research Center, Princess Nourah Bint Abdulrahman University, Riyadh, 84428, Saudi Arabia. AFAlghannam@pnu.edu.sa.'}, {'ForeName': 'Iain', 'Initials': 'I', 'LastName': 'Templeman', 'Affiliation': 'Department for Health, University of Bath, Bath, BA2 7AY, UK.'}, {'ForeName': 'Joel E', 'Initials': 'JE', 'LastName': 'Thomas', 'Affiliation': 'Department for Health, University of Bath, Bath, BA2 7AY, UK.'}, {'ForeName': 'Dawid', 'Initials': 'D', 'LastName': 'Jedrzejewski', 'Affiliation': 'Department for Health, University of Bath, Bath, BA2 7AY, UK.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Griffiths', 'Affiliation': 'Department for Health, University of Bath, Bath, BA2 7AY, UK.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Lemon', 'Affiliation': 'Department for Health, University of Bath, Bath, BA2 7AY, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Byers', 'Affiliation': 'Department for Health, University of Bath, Bath, BA2 7AY, UK.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Reeves', 'Affiliation': 'Department of Life Sciences, University of Roehampton, London, SW15 4JD, UK.'}, {'ForeName': 'Javier T', 'Initials': 'JT', 'LastName': 'Gonzalez', 'Affiliation': 'Department for Health, University of Bath, Bath, BA2 7AY, UK.'}, {'ForeName': 'Dylan', 'Initials': 'D', 'LastName': 'Thompson', 'Affiliation': 'Department for Health, University of Bath, Bath, BA2 7AY, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Bilzon', 'Affiliation': 'Department for Health, University of Bath, Bath, BA2 7AY, UK.'}, {'ForeName': 'Kostas', 'Initials': 'K', 'LastName': 'Tsintzas', 'Affiliation': ""School of Life Sciences, University of Nottingham, Queen's Medical Centre, Nottingham, NG7 2UH, UK.""}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Betts', 'Affiliation': 'Department for Health, University of Bath, Bath, BA2 7AY, UK.'}]",European journal of applied physiology,['10.1007/s00421-020-04450-1']
2389,32757825,"Strong Men, Strong Communities: Design of a Randomized Controlled Trial of a Diabetes Prevention Intervention for American Indian and Alaska Native Men.","Type 2 diabetes is a serious global epidemic that disproportionately affects disadvantaged populations. American Indians and Alaska Natives (AIs/ANs) have the highest rates of diabetes in the nation with a prevalence of 14.7% in 2018, more than twice that of non-Hispanic Whites. AI/AN men have the highest prevalence of diagnosed type 2 diabetes (14.5%) compared to non-Hispanic Black (11.4%), non-Hispanic Asian (10.0%), and non-Hispanic White (8.6%) men. Several landmark clinical trials have shown that lifestyle interventions can effectively prevent or delay the onset of diabetes among those at risk, including in AIs/ANs. Despite positive outcomes for AIs/ANs in these studies, very few were men. To date, there have been no concerted efforts to recruit and retain AI/AN men in interventions that promote weight loss and healthy lifestyles to prevent diabetes, and they remain underrepresented in these types of studies. This article describes the design and methods of the first randomized controlled trial of a diabetes prevention program with a study sample comprised entirely of AI/AN men. Research to date has demonstrated suboptimal patterns of recruitment and retention of AI/AN men, resulting in their virtual absence in health and intervention research. Effective methods to recruit and retain AI/AN men, and potential benefit gained from participation in diabetes prevention research, are unknown for this population who experience a high prevalence of type 2 diabetes. The study design presented in this article offers promising insights to help remedy these important shortcomings in the science of recruitment and retention of AI/AN men in research.",2020,"AN men have the highest prevalence of diagnosed type 2 diabetes (14.5%) compared to non-Hispanic Black (11.4%), non-Hispanic Asian (10.0%), and non-Hispanic White (8.6%) men.","['AN men have the highest prevalence of diagnosed type 2 diabetes (14.5%) compared to non-Hispanic Black (11.4%), non-Hispanic Asian (10.0%), and non-Hispanic White (8.6%) men', 'diabetes prevention program with a study sample comprised entirely of AI/AN men', 'American Indian and Alaska Native Men']",['Diabetes Prevention Intervention'],[],"[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C4517533', 'cui_str': '11.4'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C4517879', 'cui_str': '8.6'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0682125', 'cui_str': 'Native Alaskians'}]","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0537682,"AN men have the highest prevalence of diagnosed type 2 diabetes (14.5%) compared to non-Hispanic Black (11.4%), non-Hispanic Asian (10.0%), and non-Hispanic White (8.6%) men.","[{'ForeName': ""Ka'imi"", 'Initials': 'K', 'LastName': 'Sinclair', 'Affiliation': 'College of Nursing, Initiative for Research and Education to Advance Community Health (IREACH), Washington State University, Seattle, WA, USA.'}, {'ForeName': 'Cara', 'Initials': 'C', 'LastName': 'Carty', 'Affiliation': 'Initiative for Research and Education to Advance Community Health (IREACH), Washington State University, Seattle, WA, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Gonzales', 'Affiliation': 'Portland State University-Oregon Health Sciences University Joint School of Public Health, Portland, OR, USA.'}, {'ForeName': 'Cassandra', 'Initials': 'C', 'LastName': 'Nikolaus', 'Affiliation': 'Initiative for Research and Education to Advance Community Health (IREACH), Washington State University, Seattle, WA, USA.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Gillespie', 'Affiliation': 'Initiative for Research and Education to Advance Community Health (IREACH), Washington State University, Seattle, WA, USA.'}, {'ForeName': 'Dedra', 'Initials': 'D', 'LastName': 'Buchwald', 'Affiliation': 'Initiative for Research and Education to Advance Community Health (IREACH), Washington State University, Seattle, WA, USA.'}]",American journal of men's health,['10.1177/1557988320945457']
2390,32759635,Effect of Flavonoid Supplementation on Alveolar Bone Healing-A Randomized Pilot Trial.,"We investigated the effects of two common dietary supplements on bone healing in dental extraction sockets in humans. In this randomized pilot trial, male subjects took Grape Seed Extract [GSE] or Grapefruit Extract [GFE] starting two weeks prior to dental extraction and maintained this regimen for sixty days after surgery. Extraction sockets were filled with a collagen plug. After 24 h, a socket sample was collected and processed for quantitative real-time reverse transcription polymerase chain reaction (qRT-PCR) and an 84-gene wound healing assay. Sixty days after tooth extraction, a core of newly formed bone was obtained prior to dental implant placement and processed for histology. qRT-PCR revealed that GFE led to a significant decrease in platelet-derived growth factor and interleukin (IL)1-β compared to GSE, and a significant decrease in IL-6 and CXCL2 compared to control. GSE led to a significant increase in coagulation factor Von Willebrand and inflammatory marker IL1-β compared to GFE. WISP1 and CXCL5 were upregulated in both groups. Overall, GFE showed a downregulation of inflammation and GSE led to a decrease in collagen density and increased osteoclasts. This pilot trial highlights the need for further investigation on the mechanism of action of such supplements on bone healing and oral health.",2020,GSE led to a significant increase in coagulation factor Von Willebrand and inflammatory marker IL1-β compared to GFE.,"['dental extraction sockets in humans', 'male subjects took']","['Grape Seed Extract [GSE] or Grapefruit Extract [GFE', 'Flavonoid Supplementation', 'GFE', 'common dietary supplements', 'GSE']","['collagen density and increased osteoclasts', 'Alveolar Bone Healing', 'coagulation factor Von Willebrand and inflammatory marker IL1-β', 'bone healing', 'IL-6 and CXCL2', 'WISP1 and CXCL5', 'bone healing and oral health', 'platelet-derived growth factor and interleukin (IL)1-β']","[{'cui': 'C0040440', 'cui_str': 'Tooth extraction'}, {'cui': 'C0224517', 'cui_str': 'Gomphosis structure'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1515187', 'cui_str': 'Take'}]","[{'cui': 'C0772454', 'cui_str': 'Grape Seed Extract'}, {'cui': 'C0440280', 'cui_str': 'GRAPEFRUIT EXTRACT'}, {'cui': 'C0596577', 'cui_str': 'Flavonoid'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]","[{'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0029431', 'cui_str': 'Osteoclast'}, {'cui': 'C1321023', 'cui_str': 'Bone healing status'}, {'cui': 'C0005789', 'cui_str': 'Blood clotting factor'}, {'cui': 'C0042974', 'cui_str': 'von Willebrand disorder'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021755', 'cui_str': 'Interleukin-1'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0245297', 'cui_str': 'CXCL2 protein, human'}, {'cui': 'C1449212', 'cui_str': 'WISP1 protein, human'}, {'cui': 'C1435946', 'cui_str': 'CXCL5 protein, human'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0032200', 'cui_str': 'Platelet-derived growth factor'}]",,0.104126,GSE led to a significant increase in coagulation factor Von Willebrand and inflammatory marker IL1-β compared to GFE.,"[{'ForeName': 'Jose Moises', 'Initials': 'JM', 'LastName': 'Souza', 'Affiliation': 'Centro de Ciências da Saúde, Departamento de Odontologia, Campus Reitor David Ferreira Lima, Universidade Federal de Santa Catarina, Bairro Trindade, Florianópolis 88040-970, Brazil.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Tuin', 'Affiliation': 'Oral and Craniofacial Health Sciences, Adams School of Dentistry, Koury Oral Health Sciences Building, Rm 4608, CB# 7455, University of North Carolina at Chapel Hill, 385 South Columbia Street, Chapel Hill, NC 27599-7455, USA.'}, {'ForeName': 'Adam G', 'Initials': 'AG', 'LastName': 'Robinson', 'Affiliation': 'Oral and Craniofacial Health Sciences, Adams School of Dentistry, Koury Oral Health Sciences Building, Rm 4608, CB# 7455, University of North Carolina at Chapel Hill, 385 South Columbia Street, Chapel Hill, NC 27599-7455, USA.'}, {'ForeName': 'Joao Gustavo Oliveira de', 'Initials': 'JGO', 'LastName': 'Souza', 'Affiliation': 'Centro de Ciências da Saúde, Departamento de Odontologia, Campus Reitor David Ferreira Lima, Universidade Federal de Santa Catarina, Bairro Trindade, Florianópolis 88040-970, Brazil.'}, {'ForeName': 'Marco Aurelio', 'Initials': 'MA', 'LastName': 'Bianchini', 'Affiliation': 'Centro de Ciências da Saúde, Departamento de Odontologia, Campus Reitor David Ferreira Lima, Universidade Federal de Santa Catarina, Bairro Trindade, Florianópolis 88040-970, Brazil.'}, {'ForeName': 'Patricia A', 'Initials': 'PA', 'LastName': 'Miguez', 'Affiliation': 'Division of Comprehensive Oral Health, Adams School of Dentistry, Koury Oral Health Sciences Building, Rm 4610, CB# 7455, University of North Carolina at Chapel Hill, Chapel Hill, NC 77599-7455, USA.'}]",Dentistry journal,['10.3390/dj8030086']
2391,32763623,Effect of exogenous progesterone administration on smoking topography.,"INTRODUCTION


Progesterone has been implicated as protective against drug taking behaviors, including combustible cigarettes. While prior research indicates higher endogenous progesterone levels are associated with a reduction in smoking intensity (as measured by smoking topography), it is unknown if exogenous delivery of progesterone may have the same effect.
METHODS


This double-blind, counterbalanced, cross-over randomized trial enrolled women between the ages of 18 and 40 who smoked at least five cigarettes per day and were currently using oral contraceptives. After overnight abstinence participants attended two topography lab sessions. One lab session was conducted during progesterone (200 mg twice per day) treatment and the other was during placebo treatment. Analyses included linear mixed effect models to examine the effect of exogenous progesterone administration and endogenous progesterone values on topography outcomes.
RESULTS


Participants (n = 43) were 23.8 (standard deviation [SD] ± 4.5) years old, smoked 10.5 (SD ± 3.7) cigarettes per day. Compared to placebo administration, progesterone administration reduced cumulative puff volume by 300 mL (95% confidence interval [CI]: -536, -65; p-value = 0.01) with additional trends indicating possible reductions in the number of puffs, average puff volume, and average flow. There were no significant effects of endogenous progesterone on smoking topography outcomes.
CONCLUSIONS


Progesterone administration has the potential to reduce smoking intensity after overnight abstinence in women of reproductive age. Additional research is needed to explore how this may relate to smoking cessation outcomes in women of reproductive age.",2021,"Compared to placebo administration, progesterone administration reduced cumulative puff volume by 300 mL","['Participants (n\xa0=\xa043) were 23.8 (standard deviation [SD]\xa0±\xa04.5) years old, smoked 10.5 (SD\xa0±\xa03.7) cigarettes per day', 'trial enrolled women between the ages of 18 and 40 who smoked at least five cigarettes per day and were currently using oral contraceptives', 'women of reproductive age']","['progesterone', 'exogenous progesterone', 'Progesterone', 'placebo']","['cumulative puff volume', 'number of puffs, average puff volume, and average flow', 'smoking intensity', 'smoking topography']","[{'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C3844009', 'cui_str': '4.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C4517521', 'cui_str': '10.5'}, {'cui': 'C4517696', 'cui_str': '3.7'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C1527415', 'cui_str': 'Oral route'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}]","[{'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1533107', 'cui_str': 'Puff - unit of product usage'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",43.0,0.178407,"Compared to placebo administration, progesterone administration reduced cumulative puff volume by 300 mL","[{'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Allen', 'Affiliation': 'Department of Family and Community Medicine, College of Medicine - Tucson, University of Arizona, United States. Electronic address: aliciaallen@arizona.edu.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Petersen', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Minnesota, United States.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Harrison', 'Affiliation': 'Department of Family Medicine and Community Health, Medical School, University of Minnesota, United States.'}, {'ForeName': 'Uma', 'Initials': 'U', 'LastName': 'Nair', 'Affiliation': 'Department of Family and Community Medicine, College of Medicine - Tucson, University of Arizona, United States.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Allen', 'Affiliation': 'Department of Family Medicine and Community Health, Medical School, University of Minnesota, United States.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106570']
2392,32763625,Evaluation of impact-shock on gait after the implementation of two different training programs in older adults.,"BACKGROUND


Gait is negatively affected with increasing age. It is widely accepted that training produces physical-functional improvements in older adults, which can be assessed with numerous physical-functional tests. However, very few studies have been carried out using accelerometry to analyse the training effect on kinetic and kinematic variables in older adults, and there is no one that investigate the effects of two different training programs. Therefore, the aim of this study is to analyse the effects of an interval-walking program and a multicomponent program on the acceleration impacts, shock attenuation, step-length, stride frequency, and gait speed in older adults.
METHODS


23 participants were divided into multicomponent training group [n = 12, 7 female, 71.58 (4.56) years] and interval-walking group [n = 11, 6 female, 69.64 (3.56) years]. We evaluated the participants using three triaxial accelerometers, placing one on the distal end of each tibia and one on the forehead.
FINDINGS


After 14 weeks' of training, the maximum acceleration values both for the head accelerometer and for the non-dominant tibia, as well as the attenuation in the same leg, increased in the multicomponent training group. The maximum acceleration values for the head and the stride frequency also increased in the interval-walking group. Lower limb strength improved in both groups.
INTERPRETATION


Given the benefits we found for each of these programs, we encourage their consideration when planning older adults training programs and suggest that multicomponent programs should be introduced prior to the start of walking-based programs.",2020,"After 14 weeks' of training, the maximum acceleration values both for the head accelerometer and for the non-dominant tibia, as well as the attenuation in the same leg, increased in the multicomponent training group.","['participants using three triaxial accelerometers, placing one on the distal end of each tibia and one on the forehead', 'group [n\xa0=\xa012, 7 female, 71.58 (4.56) years] and interval-walking group [n\xa0=\xa011, 6 female, 69.64 (3.56) years', 'older adults', '23 participants']","['multicomponent training', 'interval-walking program and a multicomponent program']","['Lower limb strength', 'maximum acceleration values', 'stride frequency', 'acceleration impacts, shock attenuation, step-length, stride frequency, and gait speed']","[{'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0016540', 'cui_str': 'Forehead structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517763', 'cui_str': '4.56'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0000894', 'cui_str': 'Acceleration'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0427126', 'cui_str': 'Step length'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}]",23.0,0.0172172,"After 14 weeks' of training, the maximum acceleration values both for the head accelerometer and for the non-dominant tibia, as well as the attenuation in the same leg, increased in the multicomponent training group.","[{'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Sanchis-Sanchis', 'Affiliation': 'Research Group in Sports Biomechanics (GIBD), Department of Physical Education and Sports, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Blasco-Lafarga', 'Affiliation': 'Sport Performance and Physical Fitness Research Group (UIRFIDE), Department of Physical Education and Sports, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Andrés', 'Initials': 'A', 'LastName': 'Camacho-García', 'Affiliation': 'Departamento de Comunicaciones, Universitat Politècnica de València, Alcoy, Spain.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Encarnación-Martínez', 'Affiliation': 'Research Group in Sports Biomechanics (GIBD), Department of Physical Education and Sports, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Pérez-Soriano', 'Affiliation': 'Research Group in Sports Biomechanics (GIBD), Department of Physical Education and Sports, University of Valencia, Valencia, Spain. Electronic address: pedro.perez-soriano@uv.es.'}]","Clinical biomechanics (Bristol, Avon)",['10.1016/j.clinbiomech.2020.105131']
2393,32748181,Comparable effects on tear film parameters after femtosecond laser-assisted and conventional cataract surgery.,"PURPOSE


Dry eye symptoms after conventional cataract surgery are a very common problem. Until now, only few data are available on objective tear film parameters in regard to femtosecond laser-assisted cataract surgery (LCS). Aim of this study was therefore to analyze and compare tear film parameter changes between LCS and conventional cataract surgery.
METHODS


A consecutive group of 34 patients, scheduled for cataract surgery, were randomly selected for either LCS or conventional cataract surgery (17 patients/group). Tear film assessments including tear film osmolarity, Schirmer test, MMP-9 analysis via quantitative ELISA, corneal sensitivity, corneal fluorescein staining, and conjunctival fluorescein staining were sequentially evaluated pre- as well as 1 and 3 months postoperatively.
RESULTS


Both groups showed no significant difference in baseline characteristics. All surgeries were performed without any complications. After 1 and 3 months, there was no statistically significant difference in regard to tear film osmolarity (1 month: p = 0.81, 3 months: p = 1.0), Schirmer test (1 month: p = 0.35, 3 month: p = 0.08), and MMP-9 concentration (1 month: p = 0.36, 3 month: p = 0.28) between the two groups.
CONCLUSIONS


Neither LCS nor conventional cataract surgery affected objective tear film parameters significantly during our 3-month postoperative observation period. Hence, both surgical techniques can be equally used to treat patients without prior dry eye symptoms.",2020,"After 1 and 3 months, there was no statistically significant difference in regard to tear film osmolarity (1 month:","['34 patients, scheduled for cataract surgery']","['conventional cataract surgery', 'LCS', 'femtosecond laser-assisted and conventional cataract surgery', 'femtosecond laser-assisted cataract surgery (LCS', 'LCS or conventional cataract surgery', 'LCS and conventional cataract surgery']","['Tear film assessments including tear film osmolarity, Schirmer test, MMP-9 analysis via quantitative ELISA, corneal sensitivity, corneal fluorescein staining, and conjunctival fluorescein staining', 'MMP-9 concentration', 'tear film osmolarity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C1531960', 'cui_str': 'Femtosecond pulsed laser device'}]","[{'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C1704608', 'cui_str': 'Film'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0029387', 'cui_str': 'Osmolarity'}, {'cui': 'C0200152', 'cui_str': ""Schirmer's test""}, {'cui': 'C0165519', 'cui_str': 'Gelatinase B'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0014441', 'cui_str': 'Enzyme-linked immunosorbent assay'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0060520', 'cui_str': 'Fluorescein'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",34.0,0.01766,"After 1 and 3 months, there was no statistically significant difference in regard to tear film osmolarity (1 month:","[{'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Schargus', 'Affiliation': 'Department of Ophthalmology, Heinrich-Heine-University Düsseldorf, Moorenstraße 5, 40225, Düsseldorf, Germany. marc.schargus@gmx.de.'}, {'ForeName': 'Svetlana', 'Initials': 'S', 'LastName': 'Ivanova', 'Affiliation': 'Institute for Vision Science, University Eye Clinic, Ruhr-University Bochum, Bochum, Germany.'}, {'ForeName': 'Gesa', 'Initials': 'G', 'LastName': 'Stute', 'Affiliation': 'Experimental Eye Research Institute, University Eye Clinic, Ruhr-University Bochum, Bochum, Germany.'}, {'ForeName': 'H Burkhard', 'Initials': 'HB', 'LastName': 'Dick', 'Affiliation': 'Institute for Vision Science, University Eye Clinic, Ruhr-University Bochum, Bochum, Germany.'}, {'ForeName': 'Stephanie C', 'Initials': 'SC', 'LastName': 'Joachim', 'Affiliation': 'Experimental Eye Research Institute, University Eye Clinic, Ruhr-University Bochum, Bochum, Germany.'}]",International ophthalmology,['10.1007/s10792-020-01532-z']
2394,32750393,Efficacy and safety of one-month DAPT followed by 23-month ticagrelor monotherapy in patients undergoing proximal LAD stenting: Insights from the GLOBAL LEADERS trial.,"BACKGROUNDS


Data on optimal antiplatelet therapy in patients undergoing stenting of the proximal left anterior descending artery (LAD) are limited.
METHODS


This is a post-hoc analysis of the GLOBAL LEADERS trial, a prospective, multi-center, randomized controlled trial, comparing the experimental strategy (1-month dual anti-platelet therapy [DAPT] followed by 23-month ticagrelor monotherapy) with the reference regimen (12-month DAPT followed by 12-month aspirin monotherapy) in relation to stenting of the proximal LAD. The primary endpoint was the composite of all-cause death or new Q-wave myocardial infarction (MI) and key secondary safety endpoint was Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding at two years.
RESULTS


Among 15,845 patients included in the analysis, 3823 (23.9%) patients underwent stenting of the proximal LAD, while 12,022 (75.2%) did not. In the proximal LAD stenting group, there was no significant difference in the risk of the primary endpoint between the two antiplatelet strategies (3.38% vs. 3.93%; hazard ratio [HR]:0.86; 95% CI:0.62-1.20; P interaction  = 0.951). However, the risk of any MI (2.63% vs. 3.88%; HR:0.68; 95% CI:0.47-0.97; P interaction  = 0.015) and any revascularization (7.84% vs. 9.94%; HR:0.78; 95% CI:0.63-0.97; P interaction  = 0.058) was significantly lower in the experimental strategy group, while demonstrating a similar risk of BARC type 3 or 5 bleeding between the two antiplatelet strategies (1.93% vs. 1.99%; HR:0.98; 95% CI:0.62-1.54; P interaction  = 0.981).
CONCLUSIONS


The present study showed patients having stenting to the proximal LAD could potentially benefit from the experimental strategy with lower ischaemic events without a trade-off in major bleeding at two years.",2020,"In the proximal LAD stenting group, there was no significant difference in the risk of the primary endpoint between the two antiplatelet strategies (3.38% vs. 3.93%; hazard ratio [HR]:0.86; 95% CI:0.62-1.20; P interaction  = 0.951).","['patients having stenting to the proximal LAD', 'patients undergoing proximal LAD stenting', 'patients undergoing stenting of the proximal left anterior descending artery (LAD', '15,845 patients included in the analysis, 3823 (23.9%) patients underwent stenting of the proximal LAD, while 12,022 (75.2%) did not']","['dual anti-platelet therapy [DAPT', 'aspirin monotherapy', 'ticagrelor monotherapy']","['risk of any MI', 'Efficacy and safety', 'composite of all-cause death or new Q-wave myocardial infarction (MI) and key secondary safety endpoint was Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding at two years']","[{'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0226032', 'cui_str': 'Structure of anterior descending branch of left coronary artery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C1299585', 'cui_str': 'Does not'}]","[{'cui': 'C5197905', 'cui_str': 'Dual Anti-Platelet Therapy'}, {'cui': 'C0634829', 'cui_str': '1,2-dilinolenoyl-3-(4-aminobutyryl)propane-1,2,3-triol'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0429089', 'cui_str': 'Electrocardiogram Q waves'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0441731', 'cui_str': 'Type 3'}, {'cui': 'C0439234', 'cui_str': 'year'}]",15845.0,0.0682053,"In the proximal LAD stenting group, there was no significant difference in the risk of the primary endpoint between the two antiplatelet strategies (3.38% vs. 3.93%; hazard ratio [HR]:0.86; 95% CI:0.62-1.20; P interaction  = 0.951).","[{'ForeName': 'Kuniaki', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'Department of Cardiology, Amsterdam Universities Medical Centers, Location Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Rutao', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Depatment of Cardiology, Radboud University, Nijmegen, the Netherlands.'}, {'ForeName': 'Hideyuki', 'Initials': 'H', 'LastName': 'Kawashima', 'Affiliation': 'Department of Cardiology, Amsterdam Universities Medical Centers, Location Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Mariusz', 'Initials': 'M', 'LastName': 'Tomaniak', 'Affiliation': 'Department of Cardiology, Erasmus Medical University Center, Thorax Centre, Rotterdam, the Netherlands.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Gao', 'Affiliation': 'Depatment of Cardiology, Radboud University, Nijmegen, the Netherlands.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Ono', 'Affiliation': 'Department of Cardiology, Amsterdam Universities Medical Centers, Location Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Hironori', 'Initials': 'H', 'LastName': 'Hara', 'Affiliation': 'Department of Cardiology, Amsterdam Universities Medical Centers, Location Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Joanna J', 'Initials': 'JJ', 'LastName': 'Wykrzykowska', 'Affiliation': 'Department of Cardiology, Amsterdam Universities Medical Centers, Location Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Robbert J', 'Initials': 'RJ', 'LastName': 'de Winter', 'Affiliation': 'Department of Cardiology, Amsterdam Universities Medical Centers, Location Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Nikos', 'Initials': 'N', 'LastName': 'Werner', 'Affiliation': 'Department of Medicine II, Heart Center, University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Teiger', 'Affiliation': 'University Hospital Henri Mondor, Créteil, France.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Almeida', 'Affiliation': 'Hospital de Santa Cruz, Lisbon, Portugal.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Barraud', 'Affiliation': 'Clinique des Dômes, Clermont-Ferrand, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Lantelme', 'Affiliation': 'Hôpital de la Croix-Rousse, Lyon, France.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Barlis', 'Affiliation': ""Northern Hospital, Epping, Australia; St. Vincent's Heart Centre, Fitzroy, Australia.""}, {'ForeName': 'Scot', 'Initials': 'S', 'LastName': 'Garg', 'Affiliation': 'Royal Blackburn Hospital, Blackburn, United Kingdom.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hamm', 'Affiliation': 'University of Giessen, Kerckhoff Heartand Thorax Center, Bad Nauheim, Germany.'}, {'ForeName': 'Philippe Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'FACT (French Alliance for Cardiovascular Trials), Université Paris-Diderot, Paris, France.'}, {'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Onuma', 'Affiliation': 'Department of Cardiology, National University of Ireland, Galway (NUIG), Galway, Ireland.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Vranckx', 'Affiliation': 'Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa, Ziekenhuis, Hasselt, Belgium, Faculty of Medicine and Life Sciences, University of Hasselt, Hasselt, Belgium.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': 'Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Valgimigli', 'Affiliation': 'Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': 'Department of Cardiology, National University of Ireland, Galway (NUIG), Galway, Ireland. Electronic address: patrick.w.j.c.serruys@gmail.com.'}]",International journal of cardiology,['10.1016/j.ijcard.2020.07.042']
2395,32767636,A Randomised Controlled Trial Study of the Effects of a Digital Divorce Platform on Mental and Physical Health.,"BACKGROUND


Two decades of divorce research has consistently documented adverse mental and physical health effects of divorce. Responding to calls for evidence-based online divorce interventions, this study tests effects of the ""Cooperation after Divorce"" (CAD) digital intervention platform on divorcees' mental and physical health.
METHODS


Randomised control trial 12-month longitudinal study using a sample of 1,856 newly divorced Danes. Mental and physical health were measured using the SF-36 at baseline and 3, 6, and 12 months from baseline. Intervention effects were investigated using linear mixed effect models and Cohen's (d) for effect sizes.
RESULTS


The study found significant treatment effects of the CAD intervention on mental and physical health. These effects were evident across all eight health domains constituting the mental and physical health components. The study also found that the intervention group had significantly better mental health than the control group at subsequent 6- and 12-month assessments from baseline while for physical health, the intervention group had significantly better physical health at the 6-month assessment from baseline only.
CONCLUSION


The results indicate that digital solutions allowing for individually tailored user experiences may hold great potential in reducing well-known adverse health effects of divorce.
PRACTITIONER'S POINTS


The study finds highly significant treatment effects of the ""CAD"" digital divorce intervention on mental and physical health indicating that online interventions may be successfully integrated into help offered to divorcees post-divorce.",2020,"The results indicate that digital solutions allowing for individually tailored user experiences may hold great potential in reducing well-known adverse health effects of divorce.
","['1,856 newly divorced Danes']","['CAD intervention', 'Cooperation after Divorce"" (CAD) digital intervention platform', 'CAD"" digital divorce intervention', 'Digital Divorce Platform']","['mental and physical health', 'Mental and Physical Health', 'mental health', 'physical health', 'Mental and physical health']","[{'cui': 'C0012828', 'cui_str': 'Divorce'}, {'cui': 'C0337800', 'cui_str': 'Danes'}]","[{'cui': 'C0012828', 'cui_str': 'Divorce'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]",1856.0,0.0429243,"The results indicate that digital solutions allowing for individually tailored user experiences may hold great potential in reducing well-known adverse health effects of divorce.
","[{'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Sander', 'Affiliation': 'University of Copenhagen, Denmark.'}, {'ForeName': 'Gert Martin', 'Initials': 'GM', 'LastName': 'Hald', 'Affiliation': 'University of Copenhagen, Denmark.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Cipric', 'Affiliation': 'University of Copenhagen, Denmark.'}, {'ForeName': 'Camilla S', 'Initials': 'CS', 'LastName': 'Øverup', 'Affiliation': 'University of Copenhagen, Denmark.'}, {'ForeName': 'Jenna Marie', 'Initials': 'JM', 'LastName': 'Strizzi', 'Affiliation': 'University of Copenhagen, Denmark.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Gad Kjeld', 'Affiliation': 'University of Copenhagen, Denmark.'}, {'ForeName': 'Theis', 'Initials': 'T', 'LastName': 'Lange', 'Affiliation': 'University of Copenhagen, Denmark.'}]",Applied psychology. Health and well-being,['10.1111/aphw.12213']
2396,32756788,Changes in anterior segment parameters following insertion of ExPRESS mini glaucoma implant vs. trabeculectomy.,"PURPOSE


To compare changes in anterior segment parameters following ExPRESS Mini Glaucoma Shunt surgery vs. trabeculectomy using the Pentacam rotating Scheimpflug camera.
METHODS


In this prospective, comparative study, 27 patients with glaucoma treated at the Rabin Medical Center from 2009 to 2013 were enrolled in this prospective comparative study: 19 participants (19 eyes) underwent ExPRESS shunt implantation and 12 (13 eyes) underwent trabeculectomy. Changes in anterior chamber parameters at postoperative day 1 and postoperative month 3 were evaluated on Scheimpflug images.
RESULTS


Intraocular pressure decreased significantly from baseline in both groups. The decrease in both groups was similar at postoperative month 3 (p=0.82). ExPRESS surgery caused a transient increase in posterior corneal astigmatism (p=0.008) and a transient decrease in anterior chamber depth (p=0.016) and volume (p=0.006) on postoperative day 1. At postoperative month 3, these parameters were no longer statistically significant (p=0.65, p=0.51, and p=0.57 respectively). Trabeculectomy caused a transient increase in anterior and posterior corneal astigmatism on postoperative day 1 (p=0.003 and p=0.005, respectively), which were not evident at postoperative month 3 (p=1.0 and p=1.0, respectively). At postoperative month 3, both ExPRESS and trabeculectomy showed similar changes in anterior chamber parameters.
CONCLUSIONS


Both ExPRESS mini glaucoma implant and trabeculectomy significantly decreased intraocular pressure and had transient effects on anterior segment parameters, with minor differences between the methods.",2020,"Both ExPRESS mini glaucoma implant and trabeculectomy significantly decreased intraocular pressure and had transient effects on anterior segment parameters, with minor differences between the methods.",['27 patients with glaucoma treated at the Rabin Medical Center from 2009 to 2013 were enrolled in this prospective comparative study: 19 participants (19 eyes) underwent'],"['ExPRESS shunt implantation', 'insertion of ExPRESS mini glaucoma implant vs. trabeculectomy', 'Trabeculectomy', 'trabeculectomy', 'ExPRESS Mini Glaucoma Shunt surgery vs. trabeculectomy']","['anterior and posterior corneal astigmatism', 'anterior chamber depth', 'anterior chamber parameters', 'posterior corneal astigmatism', 'Intraocular pressure', 'intraocular pressure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0009491', 'cui_str': 'Comparative Studies'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}]","[{'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0542331', 'cui_str': 'Shunt'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0040574', 'cui_str': 'Trabeculoplasty'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0339682', 'cui_str': 'Regular astigmatism - corneal'}, {'cui': 'C0429492', 'cui_str': 'Depth of anterior chamber'}, {'cui': 'C0003151', 'cui_str': 'Anterior chamber of eye structure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}]",27.0,0.0158855,"Both ExPRESS mini glaucoma implant and trabeculectomy significantly decreased intraocular pressure and had transient effects on anterior segment parameters, with minor differences between the methods.","[{'ForeName': 'Eitan', 'Initials': 'E', 'LastName': 'Livny', 'Affiliation': 'Departmens of Ophthalmology, Rabin Medical Center, Petah Tikva, Israel.'}, {'ForeName': ""Na'ama"", 'Initials': 'N', 'LastName': 'Hammel', 'Affiliation': 'Departmens of Ophthalmology, Rabin Medical Center, Petah Tikva, Israel.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Mimouni', 'Affiliation': 'Department of Ophthalmology, Rambam Health Care Campus, Haifa, Israel.'}, {'ForeName': 'Moshe', 'Initials': 'M', 'LastName': 'Lusky', 'Affiliation': 'Departmens of Ophthalmology, Rabin Medical Center, Petah Tikva, Israel.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Kaiserman', 'Affiliation': 'Department of Ophthalmology, Barzilai Medical Center, Ashkelon, Israel.'}, {'ForeName': 'Irit', 'Initials': 'I', 'LastName': 'Bahar', 'Affiliation': 'Departmens of Ophthalmology, Rabin Medical Center, Petah Tikva, Israel.'}]",Arquivos brasileiros de oftalmologia,['10.5935/0004-2749.20200040']
2397,32758672,Beneficial Effects of Role Reversal in Comparison to role-playing on negative cognitions about Other's Judgments for Social Anxiety Disorder.,"BACKGROUND AND OBJECTIVES


Negative beliefs about other's judgments play an important role in the development and maintenance of social anxiety disorder. The present experiment examined the effects of role-playing followed by role reversal compared to role-playing twice on altering these negative cognitions.
METHODS


Thirty-six adult social anxiety patients were randomized into two conditions: a role-playing condition in which 18 participants role-played an anxiety-provoking social situation twice, or a role reversal condition in which 18 participants role-played an anxiety-provoking social situation followed by enacting the same situation using role reversal. Before the start of the experiment, patients were asked to report their negative cognitions about the other's judgments. Next, they were asked to rate the believability of these negative cognitions, as well as the probability and cost estimates of negative judgments by the other person, at three time-points: before the first block of role-playing, after the first block of role-playing, and after the second block of the experiment.
RESULTS


Results demonstrated that role-playing followed by role reversal had a stronger effect on the most negative cognitions than role-playing twice.
LIMITATIONS


The most important limitation of the present study is that there was no control group to assess the effects of role-playing alone. Moreover, the second block of the experiment was repetitive in role-playing, however, it was a new task in role reversal.
CONCLUSIONS


The results support the hypothesis that role reversal is an effective technique that can be used to correct negative cognitions about other's judgments in SAD.",2020,"RESULTS


Results demonstrated that role-playing followed by role reversal had a stronger effect on the most negative cognitions than role-playing twice.
","['Thirty-six adult social anxiety patients', ""negative cognitions about Other's Judgments for Social Anxiety Disorder""]","['role-playing condition in which 18 participants role-played an anxiety-provoking social situation twice, or a role reversal condition in which 18 participants role-played an anxiety-provoking social situation followed by enacting the same situation using role reversal']",[],"[{'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0022423', 'cui_str': 'Judgement'}, {'cui': 'C0031572', 'cui_str': 'Social phobia'}]","[{'cui': 'C0035822', 'cui_str': 'Role play technique'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0332282', 'cui_str': 'Following'}]",[],36.0,0.0134432,"RESULTS


Results demonstrated that role-playing followed by role reversal had a stronger effect on the most negative cognitions than role-playing twice.
","[{'ForeName': 'Hanieh', 'Initials': 'H', 'LastName': 'Abeditehrani', 'Affiliation': 'University of Amsterdam, Department of Clinical Psychology, Amsterdam, the Netherlands. Electronic address: H.Abeditehrani@uva.nl.'}, {'ForeName': 'Corine', 'Initials': 'C', 'LastName': 'Dijk', 'Affiliation': 'University of Amsterdam, Department of Clinical Psychology, Amsterdam, the Netherlands.'}, {'ForeName': 'Mohsen Dehghani', 'Initials': 'MD', 'LastName': 'Neyshabouri', 'Affiliation': 'University of Social Welfare and Rehabilitation Sciences, Department of Clinical Psychology, Tehran, Iran.'}, {'ForeName': 'Arnoud', 'Initials': 'A', 'LastName': 'Arntz', 'Affiliation': 'University of Amsterdam, Department of Clinical Psychology, Amsterdam, the Netherlands.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101599']
2398,32763240,"A Phase 1b Safety Study of SER-287, a Spore-Based Microbiome Therapeutic, for Active Mild to Moderate Ulcerative Colitis.","BACKGROUND & AIMS


Firmicutes bacteria produce metabolites that maintain the intestinal barrier and mucosal immunity. Firmicutes are reduced in the intestinal microbiota of patients with ulcerative colitis (UC). In a phase 1b trial of patients with UC, we evaluated the safety and efficacy of SER-287, an oral formulation of Firmicutes spores, and the effects of vancomycin preconditioning on expansion (engraftment) of SER-287 species in the colon.
METHODS


We conducted a double-blind trial of SER-287 in 58 adults with active mild-to-moderate UC (modified Mayo scores 4-10, endoscopic subscores ≥1). Participants received 6 days of preconditioning with oral vancomycin (125 mg, 4 times daily) or placebo followed by 8 weeks of oral SER-287 or placebo. Patients were randomly assigned (2:3:3:3) to groups that received placebo followed by either placebo or SER-287 once weekly, or vancomycin followed by SER-287 once weekly, or SER-287 once daily. Clinical end points included safety and clinical remission (modified Mayo score ≤2; endoscopic subscores 0 or 1). Microbiome end points included SER-287 engraftment (dose species detected in stool after but not before SER-287 administration). Engraftment of SER-287 and changes in microbiome composition and associated metabolites were measured by analyses of stool specimens collected at baseline, after preconditioning, and during and 4 weeks after administration of SER-287 or placebo.
RESULTS


Proportions of patients with adverse events did not differ significantly among groups. A higher proportion of patients in the vancomycin/SER-287 daily group (40%) achieved clinical remission at week 8 than patients in the placebo/placebo group (0%), placebo/SER-287 weekly group (13.3%), or vancomycin/SER-287 weekly group (17.7%) (P = .024 for vancomycin/SER-287 daily vs placebo/placebo). By day 7, higher numbers of SER-287 dose species were detected in stool samples from all SER-287 groups compared with the placebo group (P < .05), but this difference was not maintained beyond day 7 in the placebo/SER-287 weekly group. In the vancomycin groups, a greater number of dose species were detected in stool collected on day 10 and all subsequent time points through 4 weeks post dosing compared with the placebo group (P < .05). A higher number of SER-287 dose species were detected in stool samples on days 7 and 10 from subjects who received daily vs weekly SER-287 doses (P < .05). Changes in fecal microbiome composition and metabolites were associated with both vancomycin/SER-287 groups.
CONCLUSIONS


In this small phase 1b trial of limited duration, the safety and tolerability of SER-287 were similar to placebo. SER-287 after vancomycin was significantly more effective than placebo for induction of remission in patients with active mild to moderate UC. Engraftment of dose species was facilitated by vancomycin preconditioning and daily dosing of SER-287. ClinicalTrials.gov ID NCT02618187.",2020,"By day 7, higher numbers of SER-287 dose species were detected in stool samples from all SER-287 groups compared with the placebo group (P<.05), but this difference was not maintained beyond day 7 in the placebo/SER-287 weekly group.","['patients with active mild-to-moderate UC', '58 adults with active mild-to-moderate UC (modified Mayo scores 4-10, endoscopic subscores ≥1', 'active mild to moderate ulcerative colitis', 'patients with ulcerative colitis (UC', 'patients with UC']","['placebo or SER-287', 'vancomycin', 'oral SER-287 or placebo', 'placebo/placebo', 'vancomycin/SER-287 daily vs placebo/placebo', 'preconditioning with oral vancomycin', 'vancomycin followed by SER-287 once weekly or SER-287 once daily', 'placebo/SER-287', 'vancomycin/SER-287', 'vancomycin preconditioning', 'vancomycin preconditioning and daily dosing of SER-287', 'SER-287', 'placebo']","['numbers of SER-287 dose species', 'safety and efficacy of SER-287', 'safety and clinical remission (modified Mayo score ≤ 2; endoscopic subscores 0 or 1', 'microbiome composition and associated metabolites', 'intestinal microbiota', 'SER-287 engraftment', 'number of dose species', 'safety and tolerability of SER-287', 'fecal microbiome composition and metabolites', 'adverse events', 'clinical remission']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0454788', 'cui_str': 'Mayo'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0036720', 'cui_str': 'Serine'}, {'cui': 'C4517682', 'cui_str': '287'}, {'cui': 'C0042313', 'cui_str': 'Vancomycin'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1709632', 'cui_str': 'Precondition'}, {'cui': 'C0360373', 'cui_str': 'Vancomycin-containing product in oral dose form'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0558293', 'cui_str': 'Once a week'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0036720', 'cui_str': 'Serine'}, {'cui': 'C4517682', 'cui_str': '287'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0454788', 'cui_str': 'Mayo'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C1956108', 'cui_str': 'Microbiome'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0301944', 'cui_str': 'Graft acceptance'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",58.0,0.414313,"By day 7, higher numbers of SER-287 dose species were detected in stool samples from all SER-287 groups compared with the placebo group (P<.05), but this difference was not maintained beyond day 7 in the placebo/SER-287 weekly group.","[{'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Henn', 'Affiliation': 'Seres Therapeutics, Cambridge, Massachusetts. Electronic address: mhenn@serestherapeutics.com.'}, {'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': ""O'Brien"", 'Affiliation': 'Seres Therapeutics, Cambridge, Massachusetts.'}, {'ForeName': 'Liyang', 'Initials': 'L', 'LastName': 'Diao', 'Affiliation': 'Seres Therapeutics, Cambridge, Massachusetts.'}, {'ForeName': 'Brian G', 'Initials': 'BG', 'LastName': 'Feagan', 'Affiliation': 'Robarts Research Institute, London, Ontario, Canada.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Sandborn', 'Affiliation': 'University of California San Diego, La Jolla, California.'}, {'ForeName': 'Curtis', 'Initials': 'C', 'LastName': 'Huttenhower', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Boston, Massachusetts; (5)Borland Groover Clinic, Jacksonville, FL.'}, {'ForeName': 'Jennifer R', 'Initials': 'JR', 'LastName': 'Wortman', 'Affiliation': 'Seres Therapeutics, Cambridge, Massachusetts.'}, {'ForeName': 'Barbara H', 'Initials': 'BH', 'LastName': 'McGovern', 'Affiliation': 'Seres Therapeutics, Cambridge, Massachusetts.'}, {'ForeName': 'Sherry', 'Initials': 'S', 'LastName': 'Wang-Weigand', 'Affiliation': 'Seres Therapeutics, Cambridge, Massachusetts.'}, {'ForeName': 'David I', 'Initials': 'DI', 'LastName': 'Lichter', 'Affiliation': 'Seres Therapeutics, Cambridge, Massachusetts.'}, {'ForeName': 'Meghan', 'Initials': 'M', 'LastName': 'Chafee', 'Affiliation': 'Seres Therapeutics, Cambridge, Massachusetts.'}, {'ForeName': 'Chris B', 'Initials': 'CB', 'LastName': 'Ford', 'Affiliation': 'Seres Therapeutics, Cambridge, Massachusetts.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Bernardo', 'Affiliation': 'Seres Therapeutics, Cambridge, Massachusetts.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Zhao', 'Affiliation': 'Seres Therapeutics, Cambridge, Massachusetts.'}, {'ForeName': 'Sheri', 'Initials': 'S', 'LastName': 'Simmons', 'Affiliation': 'Seres Therapeutics, Cambridge, Massachusetts.'}, {'ForeName': 'Amelia', 'Initials': 'A', 'LastName': 'Tomlinson', 'Affiliation': 'Seres Therapeutics, Cambridge, Massachusetts.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cook', 'Affiliation': 'Seres Therapeutics, Cambridge, Massachusetts.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Pomerantz', 'Affiliation': 'Seres Therapeutics, Cambridge, Massachusetts.'}, {'ForeName': 'Bharat K', 'Initials': 'BK', 'LastName': 'Misra', 'Affiliation': 'Seres Therapeutics, Cambridge, Massachusetts.'}, {'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'Auninš', 'Affiliation': 'Seres Therapeutics, Cambridge, Massachusetts.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Trucksis', 'Affiliation': 'Seres Therapeutics, Cambridge, Massachusetts.'}]",Gastroenterology,['10.1053/j.gastro.2020.07.048']
2399,32765963,Impact of a Maternal Prevention of Mother-to-child Transmission of HIV (PMTCT) Intervention on HIV-exposed Infants in Uganda.,"Background


Uganda has successfully reduced pediatric HIV infections through prevention of mother-to-child transmission of HIV (PMTCT) programs, yet little is known about adherence to infant-specific components of interventions. We hypothesized that infants born to mothers receiving the WiseMama (WM) electronic drug monitoring (EDM)-based adherence intervention would have increased uptake of six-week post-natal nevirapine (NVP) infant prophylaxis and better adherence to six-week early infant diagnosis (EID) HIV testing.
Methods


At two sites in Uganda, the Wise Infant Study (WIN) prospectively followed an infant cohort. Infants were born to women enrolled in an RCT testing the effect of real-time reminders delivered via EDM on maternal adherence to antiretroviral therapy. We assessed intrapartum and discharge receipt of NVP prophylaxis using pharmacy and infant HIV DNA testing laboratory data.
Results


Of 121 women eligible for WIN, 97 (80%) consented and enrolled; 46 had been randomized to control and 51 to intervention. There were no differences in receipt of a six-week NVP supply (control 87%, intervention 82%, p = 0.53). Receipt of any NVP prophylaxis did not vary by delivery location (p = 0.35), and although 12% of infants were delivered at non-study health facilities, they were not less likely to receive NVP at discharge (p = 0.37). Among infants with a completed HIV test, there was no difference in mean time to first test (control 52 days (SD 18), intervention 51 days (SD 15), p = 0.86). Only one infant, in the control group, tested positive for HIV.
Conclusion and Global Health Implications


We found no significant differences in adherence to infant PMTCT practices between intervention and control infants with relatively high rates of NVP receipt albeit with suboptimal adherence to six-week EID testing. Further work is needed to ensure improved access, uptake, and follow-up of HIV-exposed infants in the Option B+ era.",2020,"There were no differences in receipt of a six-week NVP supply (control 87%, intervention 82%, p = 0.53).","['infants born to mothers receiving the', '121 women eligible for WIN, 97 (80%) consented and enrolled; 46', 'HIV-exposed Infants in Uganda']","['WiseMama (WM) electronic drug monitoring (EDM)-based adherence intervention', 'Maternal Prevention of Mother-to-child Transmission of HIV (PMTCT']","['mean time to first test', 'receipt of a six-week NVP supply']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}]","[{'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0085421', 'cui_str': 'Medication monitoring'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0282474', 'cui_str': 'Infection Transmission, Maternal-Fetal'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0132326', 'cui_str': 'Nevirapine'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}]",121.0,0.121712,"There were no differences in receipt of a six-week NVP supply (control 87%, intervention 82%, p = 0.53).","[{'ForeName': 'Anays', 'Initials': 'A', 'LastName': 'Murillo', 'Affiliation': 'Department of Global Health, Boston University School of Public Health, Boston University, 801 Massachusetts Avenue Crosstown Center, 3 Floor, Boston, MA, 02118 USA.'}, {'ForeName': 'Mary Bachman', 'Initials': 'MB', 'LastName': 'DeSilva', 'Affiliation': 'University of New England, 716 Stevens Ave, Portland, ME, 04103 USA.'}, {'ForeName': 'Lora L', 'Initials': 'LL', 'LastName': 'Sabin', 'Affiliation': 'Department of Global Health, Boston University School of Public Health, Boston University, 801 Massachusetts Avenue Crosstown Center, 3 Floor, Boston, MA, 02118 USA.'}, {'ForeName': 'Nafisa', 'Initials': 'N', 'LastName': 'Halim', 'Affiliation': 'Department of Global Health, Boston University School of Public Health, Boston University, 801 Massachusetts Avenue Crosstown Center, 3 Floor, Boston, MA, 02118 USA.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'Chemusto', 'Affiliation': 'Mildmay Uganda, Lweza Kampala-Entebbe Road, Kampala, Uganda.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Aroda', 'Affiliation': 'Mildmay Uganda, Lweza Kampala-Entebbe Road, Kampala, Uganda.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Gasuza', 'Affiliation': 'Mildmay Uganda, Lweza Kampala-Entebbe Road, Kampala, Uganda.'}, {'ForeName': 'Davidson H', 'Initials': 'DH', 'LastName': 'Hamer', 'Affiliation': 'Department of Global Health, Boston University School of Public Health, Boston University, 801 Massachusetts Avenue Crosstown Center, 3 Floor, Boston, MA, 02118 USA.'}, {'ForeName': 'Anna Larson', 'Initials': 'AL', 'LastName': 'Williams', 'Affiliation': 'Department of Global Health, Boston University School of Public Health, Boston University, 801 Massachusetts Avenue Crosstown Center, 3 Floor, Boston, MA, 02118 USA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Mukasa', 'Affiliation': 'Mildmay Uganda, Lweza Kampala-Entebbe Road, Kampala, Uganda.'}, {'ForeName': 'Lisa J', 'Initials': 'LJ', 'LastName': 'Messersmith', 'Affiliation': 'Department of Global Health, Boston University School of Public Health, Boston University, 801 Massachusetts Avenue Crosstown Center, 3 Floor, Boston, MA, 02118 USA.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Bonawitz', 'Affiliation': 'Department of Global Health, Boston University School of Public Health, Boston University, 801 Massachusetts Avenue Crosstown Center, 3 Floor, Boston, MA, 02118 USA.'}]",International journal of MCH and AIDS,['10.21106/ijma.380']
2400,32762148,Effects of a Lifestyle Intervention Based on Type D Personality in Overweight and Obese Middle-Aged Women: A Feasibility Study.,"BACKGROUND


Obesity is an important public health problem, particularly among middle-aged women. Type D personality, characterized by negative affectivity and social inhibition, is prevalent among obese and overweight middle-aged women and has been linked to maladaptive health-related behaviors and unhealthy lifestyle. Lifestyle interventions based on type D personality could be a first step in combatting obesity in middle-aged women.
AIM


To identify the effects of a lifestyle intervention based on type D personality on health-promoting lifestyle behaviors, psychological distress, type D personality, and body composition in overweight and obese middle-aged women.
METHODS


A total of 36 overweight and obese middle-aged women participated in a quasi-experimental design using a non-equivalent control group pretest-posttest. The experimental group received a total of eight sessions of a lifestyle intervention program based on type D personality over the course of four weeks. Outcomes were measured health-promoting lifestyle behaviors, psychological distress, type D personality, and body composition (body weight, body mass index, body fat, and abdominal fat).
RESULTS


Following the intervention, the experimental group scored significantly higher than the control group for health-promoting lifestyle behaviors, and significantly lower than the control group for psychological distress and type D personality. Body weight and body mass index decreased significantly in the experimental group compared to the control group.
LINKING EVIDENCE TO ACTION


Further research on various intervention programs for overweight and obese middle-aged women is warranted, including lifestyle interventions based on type D personality.",2020,"Following the intervention, the experimental group scored significantly higher than the control group for health-promoting lifestyle behaviors, and significantly lower than the control group for psychological distress and type D personality.","['overweight and obese middle-aged women', 'Type D Personality in Overweight and Obese Middle-Aged Women', 'middle-aged women', 'obese and overweight middle-aged women', '36 overweight and obese middle-aged women participated in a']","['lifestyle intervention', 'Lifestyle Intervention', 'Lifestyle interventions', 'quasi-experimental design using a non-equivalent control group pretest-posttest', 'lifestyle intervention program']","['health-promoting lifestyle behaviors', 'psychological distress and type D personality', 'health-promoting lifestyle behaviors, psychological distress, type D personality, and body composition (body weight, body mass index, body fat, and abdominal fat', 'Body weight and body mass index', 'health-promoting lifestyle behaviors, psychological distress, type D personality, and body composition']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3658239', 'cui_str': 'Personality Type D'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C3658239', 'cui_str': 'Personality Type D'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C1563742', 'cui_str': 'Fat, Abdominal'}]",36.0,0.0166452,"Following the intervention, the experimental group scored significantly higher than the control group for health-promoting lifestyle behaviors, and significantly lower than the control group for psychological distress and type D personality.","[{'ForeName': 'Sung Reul', 'Initials': 'SR', 'LastName': 'Kim', 'Affiliation': 'College of Nursing, Korea University, Seoul, South Korea.'}, {'ForeName': 'Ju-Hee', 'Initials': 'JH', 'LastName': 'Nho', 'Affiliation': 'College of Nursing, Jeonbuk Research Institute of Nursing Science, Jeonbuk National University, Jeonju, South Korea.'}, {'ForeName': 'Ji Young', 'Initials': 'JY', 'LastName': 'Kim', 'Affiliation': 'College of Nursing, Jeonbuk Research Institute of Nursing Science, Jeonbuk National University, Jeonju, South Korea.'}, {'ForeName': 'Joon', 'Initials': 'J', 'LastName': 'Hur', 'Affiliation': 'Department of Internal Medicine, Jiangun Medical Center, Jinangun, South Korea.'}]",Worldviews on evidence-based nursing,['10.1111/wvn.12457']
2401,32758689,"SARS-CoV-2 clearance in COVID-19 patients with Novaferon treatment: A randomized, open-label, parallel-group trial.","BACKGROUND


The antiviral effects of Novaferon, a potent antiviral protein drug, on COVID-19 was evaluated in the laboratory, and in a randomized, open-label, parallel-group trial.
METHODS


In the laboratory, Novaferon's inhibition of viral replication in cells infected with SARS-CoV-2, and prevention of SARS-CoV-2 entry into healthy cells was determined. Antiviral effects of Novaferon in COVID-19 patients with treatment of Novaferon, Novaferon plus Lopinavir/Ritonavir, or Lopinavir/Ritonavir were evaluated. The primary endpoint was the SARS-CoV-2 clearance rates on day six of treatment, and the secondary endpoint was the time to SARS-CoV-2 clearance.
RESULTS


Novaferon inhibited viral replication (EC 50 =1.02ng/ml), and prevented viral infection (EC 50 =0.10ng/ml). Results from the 89 enrolled COVID-19 patients showed that both Novaferon and Novaferon plus Lopinavir/Ritonavir groups had significantly higher viral clearance rates on day six than Lopinavir/Ritonavir group (50.0% vs. 24.1%, p=0.0400, and 60.0% vs. 24.1%, p=0.0053). The median time to viral clearance was six days, six days, and nine days for three groups, respectively, a 3-day reduction in both the Novaferon and Novaferon plus Lopinavir/Ritonavir groups compared with the Lopinavir/Ritonavir group.
CONCLUSIONS


Novaferon exhibited anti-SARS-CoV-2 effects in vitro and in COVID-19 patients. These data justify further evaluation of Novaferon.
TRIAL REGISTRATION NUMBER


Number ChiCTR2000029496 at the Chinese Clinical Trial Registry (http://www.chictr.org.cn/).",2020,"RESULTS


Novaferon inhibited the viral replication (EC 50  = 1.02 ng/ml), and prevented viral infection (EC 50  = 0.10 ng/ml).","['COVID-19 patients with treatment of Novaferon', 'COVID-19 Patients with Novaferon Treatment']","['Lopinavir/Ritonavir', 'Novaferon plus Lopinavir/Ritonavir, or Lopinavir/Ritonavir', 'Novaferon', '6than Lopinavir/Ritonavir']","['viral infection', 'SARS-CoV-2 Clearance', 'Median time to viral clearance', 'viral replication', 'SARS-CoV-2 clearance rates', 'time to SARS-CoV-2 clearance', 'viral clearance rates']","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3273451', 'cui_str': 'Novaferon'}]","[{'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}, {'cui': 'C3273451', 'cui_str': 'Novaferon'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0042774', 'cui_str': 'Virus Replication'}, {'cui': 'C0025515', 'cui_str': 'Metabolic clearance rate'}]",89.0,0.111733,"RESULTS


Novaferon inhibited the viral replication (EC 50  = 1.02 ng/ml), and prevented viral infection (EC 50  = 0.10 ng/ml).","[{'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Zheng', 'Affiliation': 'Department of Infectious Diseases, The First Hospital of Changsha, Changsha, China.'}, {'ForeName': 'Yanwen', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Department of Infectious Diseases, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Zhiguo', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'Department of Respiratory Medicine, The First Hospital of Changsha, Changsha, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Ye', 'Affiliation': 'National Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Baoying', 'Initials': 'B', 'LastName': 'Huang', 'Affiliation': 'National Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Yaxiong', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Department of Infectious Diseases, The First Hospital of Changsha, Changsha, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Department of Infectious Diseases, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Zuo', 'Affiliation': 'Department of Intensive Care Unit, The First Hospital of Changsha, Changsha, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Tan', 'Affiliation': 'Department of Pediatrics, The First Hospital of Changsha, Changsha, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Xie', 'Affiliation': 'Department of Internal Medicine, The First Hospital of Changsha, Changsha, China.'}, {'ForeName': 'Peihua', 'Initials': 'P', 'LastName': 'Niu', 'Affiliation': 'National Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Wenlong', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Infectious Diseases, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Department of Infectious Diseases, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Peng', 'Affiliation': 'Department of Infectious Diseases, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Zhou', 'Affiliation': 'Department of Infectious Diseases, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Chunlin', 'Initials': 'C', 'LastName': 'Cai', 'Affiliation': 'Department of Infectious Diseases, The First Hospital of Changsha, Changsha, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Tang', 'Affiliation': 'Department of Infectious Diseases, The First Hospital of Changsha, Changsha, China.'}, {'ForeName': 'Xinqiang', 'Initials': 'X', 'LastName': 'Xiao', 'Affiliation': 'Department of Infectious Diseases, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Infectious Diseases, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Zhiguang', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'Key Laboratory of Diabetes Immunology (Central South University), Ministry of Education, National Clinical Research Center for Metabolic Diseases, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Yongfang', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Department of Infectious Diseases, The Second Xiangya Hospital, Central South University, Changsha, China. Electronic address: jiangyongfang@csu.edu.cn.'}, {'ForeName': 'Yuanlin', 'Initials': 'Y', 'LastName': 'Xie', 'Affiliation': 'Department of Infectious Diseases, The First Hospital of Changsha, Changsha, China. Electronic address: 1286779459@qq.com.'}, {'ForeName': 'Wenjie', 'Initials': 'W', 'LastName': 'Tan', 'Affiliation': 'National Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China. Electronic address: tanwj@ivdc.chinacdc.cn.'}, {'ForeName': 'Guozhong', 'Initials': 'G', 'LastName': 'Gong', 'Affiliation': 'Department of Infectious Diseases, The Second Xiangya Hospital, Central South University, Changsha, China. Electronic address: gongguozhong@csu.edu.cn.'}]",International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases,['10.1016/j.ijid.2020.07.053']
2402,32763002,"Response to Letter to Editor ""Effects of handwriting exercise on functional outcome in parkinson disease: A randomized controlled trial"".",,2020,,['parkinson disease'],['handwriting exercise'],['functional outcome'],"[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}]","[{'cui': 'C0018582', 'cui_str': 'Handwriting'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.0973615,,[],Journal of clinical neuroscience : official journal of the Neurosurgical Society of Australasia,['10.1016/j.jocn.2020.07.001']
2403,32764634,"Randomised, double-blind, placebo-controlled trial of oral probiotic Streptococcus salivarius M18 on head and neck cancer patients post-radiotherapy: a pilot study.","Xerostomia detrimentally affects the oral health of many head and neck cancer patients who undergo radiotherapy. Its sequelae become an ongoing burden for patients that often manifest as periodontal disease and dental decay. Bacteria play a major role in the pathogenesis of these conditions and here we explore the use of an oral probiotic to beneficially modulate the oral bacterial community post-radiotherapy. In this pilot study, a four-week intervention with oral probiotic lozenges containing Streptococcus salivarius M18 was trialled in seven patients. Post-intervention changes in oral health and in the composition of the plaque and saliva bacterial communities were compared with six patients in a placebo group. An improvement in periodontal screening and plaque index scores was observed in both groups after the intervention period. The oral probiotic lozenges did not significantly impact bacterial community composition or diversity, nor did the probiotic lozenges increase the relative sequence abundance of ZOTU_1 (the probiotic-associated sequence assigned to S. salivarius) detected in the samples. Network analyses suggest negative interactions occurred between ZOTU_1 and species from the periopathogenic genera Campylobacter, Fretibacterium, Selenomonas and Treponema but further investigation is required to more fully understand the beneficial properties of this oral probiotic.",2020,"The oral probiotic lozenges did not significantly impact bacterial community composition or diversity, nor did the probiotic lozenges increase the relative sequence abundance of ZOTU_1 (the probiotic-associated sequence assigned to S. salivarius) detected in the samples.","['head and neck cancer patients post', 'seven patients', 'many head and neck cancer patients who undergo radiotherapy']","['oral probiotic lozenges', 'oral probiotic Streptococcus salivarius M18', 'radiotherapy', 'placebo']","['periodontal screening and plaque index scores', 'relative sequence abundance of ZOTU_1']","[{'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0991564', 'cui_str': 'Lozenge'}, {'cui': 'C0318179', 'cui_str': 'Streptococcus salivarius'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}]",7.0,0.0738193,"The oral probiotic lozenges did not significantly impact bacterial community composition or diversity, nor did the probiotic lozenges increase the relative sequence abundance of ZOTU_1 (the probiotic-associated sequence assigned to S. salivarius) detected in the samples.","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Vesty', 'Affiliation': 'Department of Surgery, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Gear', 'Affiliation': 'Department of Otorhinolaryngology, Auckland District Health Board, Auckland, New Zealand.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Boutell', 'Affiliation': 'Oral Health, Auckland University of Technology, Auckland, New Zealand.'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Taylor', 'Affiliation': 'School of Biological Sciences, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Richard G', 'Initials': 'RG', 'LastName': 'Douglas', 'Affiliation': 'Department of Surgery, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Kristi', 'Initials': 'K', 'LastName': 'Biswas', 'Affiliation': 'Department of Surgery, The University of Auckland, Auckland, New Zealand. k.biswas@auckland.ac.nz.'}]",Scientific reports,['10.1038/s41598-020-70024-y']
2404,32772246,Increased fascicle length but not patellar tendon stiffness after accentuated eccentric-load strength training in already-trained men.,"PURPOSE


This study examined whether additional external load during the eccentric phase of lower limb strength training exercises led to greater adaptations in knee extensor strength, muscle architecture, and patellar tendon properties than traditional concentric-eccentric training in already-trained men.
METHODS


Twenty-eight men accustomed to strength training were randomized to undertake 10 weeks of supervised traditional (TRAD) or accentuated eccentric loading (AEL) or continue their habitual unsupervised (CON) strength training. TRAD and AEL trained 2∙week -1  with a six-repetition maximum (RM) session and a ten-RM session. TRAD used the same external load in both concentric and eccentric phases, while AEL used 40% greater load during the eccentric than concentric phase. Tests were performed at pre- and post-training, including: maximum unilateral isokinetic (30°·s -1 ) concentric, eccentric and isometric torques by isokinetic dynamometry, unilateral isometric ramp contractions with muscle-tendon ultrasound imaging to measure tendon stiffness and hysteresis, and resting vastus lateralis and medialis fascicle angle and length measured by extended-field-of-view ultrasound.
RESULTS


After training, both TRAD and AEL significantly increased maximum concentric and isometric torque (p < 0.05), but only AEL increased eccentric torque (AEL: + 10 ± 9%, TRAD: + 4 ± 9%) and vastus lateralis (AEL: + 14 ± 14%, TRAD: + 1 ± 10%) and medialis (AEL: + 19 ± 8%, TRAD: + 5 ± 11%) fascicle length.
CONCLUSION


Both TRAD and AEL increased maximum knee extensor strength but only AEL increased VL and VM fascicle length. Neither training program promoted changes in fascicle angle or changes in patellar tendon properties in our already-trained men.",2020,"After training, both TRAD and AEL significantly increased maximum concentric and isometric torque (p < 0.05), but only AEL increased eccentric torque (AEL: + 10 ± 9%, TRAD: + 4 ± 9%) and vastus lateralis (AEL: + 14 ± 14%, TRAD: + 1 ± 10%) and medialis (AEL: + 19 ± 8%, TRAD: + 5 ± 11%) fascicle length.
CONCLUSION


","['already-trained men', 'Twenty-eight men accustomed to strength training']","['supervised traditional (TRAD) or accentuated eccentric loading (AEL) or continue their habitual unsupervised (CON) strength training', 'maximum unilateral isokinetic (30°·s -1 ) concentric, eccentric and isometric torques by isokinetic dynamometry, unilateral isometric ramp contractions with muscle-tendon ultrasound imaging to measure tendon stiffness and hysteresis, and resting vastus lateralis and medialis fascicle angle and length measured by extended-field-of-view ultrasound', 'traditional concentric-eccentric training']","['maximum knee extensor strength', 'eccentric torque (AEL', 'maximum concentric and isometric torque', 'Increased fascicle length', 'fascicle angle or changes in patellar tendon properties', 'knee extensor strength, muscle architecture, and patellar tendon properties', 'VL and VM fascicle length']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C1997416', 'cui_str': 'Accentuated'}, {'cui': 'C0439740', 'cui_str': 'Eccentric'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0439744', 'cui_str': 'Concentric'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0034646', 'cui_str': 'Ramp'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0039508', 'cui_str': 'Tendon structure'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0439740', 'cui_str': 'Eccentric'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0439744', 'cui_str': 'Concentric'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0206332', 'cui_str': 'Structure of patellar ligament'}, {'cui': 'C0871161', 'cui_str': 'Property'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0003737', 'cui_str': 'Architecture'}]",,0.0128459,"After training, both TRAD and AEL significantly increased maximum concentric and isometric torque (p < 0.05), but only AEL increased eccentric torque (AEL: + 10 ± 9%, TRAD: + 4 ± 9%) and vastus lateralis (AEL: + 14 ± 14%, TRAD: + 1 ± 10%) and medialis (AEL: + 19 ± 8%, TRAD: + 5 ± 11%) fascicle length.
CONCLUSION


","[{'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Walker', 'Affiliation': 'NeuroMuscular Research Center, Faculty of Sport and Health Sciences, University of Jyväskylä, Room VIV223, 40014, Jyväskylä, Finland. simon.walker@jyu.fi.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Trezise', 'Affiliation': 'School of Medical and Health Sciences, Centre for Exercise and Sports Science Research, Edith Cowan University, Joondalup, WA, Australia.'}, {'ForeName': 'Guy Gregory', 'Initials': 'GG', 'LastName': 'Haff', 'Affiliation': 'School of Medical and Health Sciences, Centre for Exercise and Sports Science Research, Edith Cowan University, Joondalup, WA, Australia.'}, {'ForeName': 'Robert U', 'Initials': 'RU', 'LastName': 'Newton', 'Affiliation': 'School of Medical and Health Sciences, Centre for Exercise and Sports Science Research, Edith Cowan University, Joondalup, WA, Australia.'}, {'ForeName': 'Keijo', 'Initials': 'K', 'LastName': 'Häkkinen', 'Affiliation': 'NeuroMuscular Research Center, Faculty of Sport and Health Sciences, University of Jyväskylä, Room VIV223, 40014, Jyväskylä, Finland.'}, {'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'Blazevich', 'Affiliation': 'School of Medical and Health Sciences, Centre for Exercise and Sports Science Research, Edith Cowan University, Joondalup, WA, Australia.'}]",European journal of applied physiology,['10.1007/s00421-020-04462-x']
2405,32772268,PICSI vs. MACS for abnormal sperm DNA fragmentation ICSI cases: a prospective randomized trial.,"PURPOSE


To know which sperm selection technique, physiological intracytoplasmic sperm injection (PICSI) or magnetic-activated cell sorting (MACS), is better for the selection of sperm with abnormal sperm DNA fragmentation (SDF) in patients undergoing intracytoplasmic sperm injection (ICSI).
METHODS


A prospective randomized trial included 413 ICSI cases with abnormal SDF (> 20.3%) by TUNEL assay. Patients with at least 1 million total progressive motile sperm count were randomized to PICSI or MACS groups on the day of ICSI. PICSI depends on the hyaluronan binding of better SDF sperm where individual sperm was selected, while MACS selects non-apoptotic sperm population using Annexin V magnetic beads. All pre-implantation embryogenic parameters were observed and the main outcome was the ongoing pregnancy rate.
RESULTS


There were no significant differences between patients allocated to PICSI and MACS in the studied parameters including pre-implantation embryological data, implantation, clinical pregnancy, and ongoing pregnancy rates. Meanwhile, sub-analysis according to the female age has shown that female patients with less than 30 years of age in the MACS group had significantly higher good-quality blastocyst, clinical pregnancy, and ongoing pregnancy rates than the PICSI group. However, the higher implantation (p = 0.051), clinical pregnancy (p = 0.078), and ongoing pregnancy (p = 0.097) rates observed in females between 30 and 35 years of age in the PICSI group did not reach significance level.
CONCLUSIONS


PICSI and MACS are efficient techniques for sperm selection in cases with abnormal sperm DNA fragmentation. However, MACS is preferred when the females are younger than 30 years, while PICSI is preferred in older females.
CLINICAL TRIAL REGISTRATION NUMBER


NCT03398317 (retrospectively registered).",2020,"There were no significant differences between patients allocated to PICSI and MACS in the studied parameters including pre-implantation embryological data, implantation, clinical pregnancy, and ongoing pregnancy rates.","['Patients with at least 1 million total progressive motile sperm count', '413 ICSI cases with abnormal SDF (>\u200920.3%) by TUNEL assay', 'patients undergoing intracytoplasmic sperm injection (ICSI', 'female patients with less than 30\xa0years of age in the']","['physiological intracytoplasmic sperm injection (PICSI) or magnetic-activated cell sorting ', 'PICSI or MACS', 'PICSI and MACS', 'PICSI vs. MACS', 'MACS']","['ongoing pregnancy', 'good-quality blastocyst, clinical pregnancy, and ongoing pregnancy rates', 'pre-implantation embryological data, implantation, clinical pregnancy, and ongoing pregnancy rates', 'clinical pregnancy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1881839', 'cui_str': '1000000'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0577264', 'cui_str': 'Sperm motile'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0455164', 'cui_str': 'IVF - In vitro fertilization with intracytoplasmic sperm injection (ICSI)'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0037868', 'cui_str': 'Spermatozoa'}, {'cui': 'C0376669', 'cui_str': 'DNA Fragmentation'}, {'cui': 'C0600528', 'cui_str': 'In Situ Nick End Labeling'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0455164', 'cui_str': 'IVF - In vitro fertilization with intracytoplasmic sperm injection (ICSI)'}, {'cui': 'C0024488', 'cui_str': 'Magnetics'}, {'cui': 'C0007616', 'cui_str': 'Cell Isolation'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C1281743', 'cui_str': 'Blastocyst structure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]",413.0,0.0907136,"There were no significant differences between patients allocated to PICSI and MACS in the studied parameters including pre-implantation embryological data, implantation, clinical pregnancy, and ongoing pregnancy rates.","[{'ForeName': 'Eman', 'Initials': 'E', 'LastName': 'Hasanen', 'Affiliation': 'IVF Laboratory, Ganin Fertility Center, Cairo, 11728, Egypt. em.saberh@gmail.com.'}, {'ForeName': 'Khaled', 'Initials': 'K', 'LastName': 'Elqusi', 'Affiliation': 'IVF Laboratory, Ganin Fertility Center, Cairo, 11728, Egypt.'}, {'ForeName': 'Salma', 'Initials': 'S', 'LastName': 'ElTanbouly', 'Affiliation': 'IVF Laboratory, Ganin Fertility Center, Cairo, 11728, Egypt.'}, {'ForeName': 'Abd ElGhafar', 'Initials': 'AE', 'LastName': 'Hussin', 'Affiliation': 'IVF Laboratory, Ganin Fertility Center, Cairo, 11728, Egypt.'}, {'ForeName': 'Hanaa', 'Initials': 'H', 'LastName': 'AlKhadr', 'Affiliation': 'IVF Laboratory, Ganin Fertility Center, Cairo, 11728, Egypt.'}, {'ForeName': 'Hosam', 'Initials': 'H', 'LastName': 'Zaki', 'Affiliation': 'IVF Laboratory, Ganin Fertility Center, Cairo, 11728, Egypt.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Henkel', 'Affiliation': 'University of the Western Cape, Cape Town, South Africa.'}, {'ForeName': 'Ashok', 'Initials': 'A', 'LastName': 'Agarwal', 'Affiliation': 'American Center for Reproductive Medicine, Cleveland Clinic, Cleveland, OH, USA.'}]",Journal of assisted reproduction and genetics,['10.1007/s10815-020-01913-4']
2406,32772319,Does cognitive behavioral education reduce pain and improve joint function in patients after total knee arthroplasty? A randomized controlled trial.,"INTRODUCTION


Cognitive behavioral therapy (CBT) is an effective treatment for reducing the pain of knee osteoarthritis (OA) and improving joint function. However, there are few studies on the effect of CBT on the pain severity after total knee arthroplasty (TKA). This study investigates the effectiveness of a CBT program on pain, knee function, quality of life, and pain catastrophizing in patients after TKA.
METHODS


This was a randomized, parallel-group, controlled trial in which 100 patients with knee osteoarthritis (OA) prepared for TKA were randomly assigned to participate in CBT or usual care group. Evaluation outcomes include Visual Analogue Scale (VAS), Pain Catastrophizing Scale (PCS), Oxford Knee Score (OKS), Knee Range of Motion (ROM), EuroQol Five-Dimensional (EQ-5D), and Hospital for Special Surgery (HSS) Knee Rating Scale before and after surgery.
RESULTS


We found that patients in the CBT group had a lower pain during activity from the fifth day (p = 0.003) to the third month (p = 0.019) after TKA. At the 12th month, the mean VAS score during activity in the CBT and usual care groups decreased from 4.5 to 0.8 and from 4.6 to 0.9, respectively, and there is no significant difference between the two groups. The PCS scores of patients in the CBT group were lower than those in the usual care group at 1st (p = 0.014) and 3rd months (p = 0.027) after surgery. No statistically significantly differences between the two groups in pain during rest, knee ROM, EQ-5D, OKS, and HSS.
CONCLUSIONS


The CBT program was superior to usual care in reducing post-operative pain during activity from the fifth day to the third month and pain catastrophing in the first three months after TKA but has no statistically significantly differences in pain during rest, knee ROM, EQ-5D, OKS, and HSS.
TRIAL REGISTRATION


Current Controlled Trials ChiCTR2000032857, date of registration: May, 14, 2020, retrospectively registered.",2020,"No statistically significantly differences between the two groups in pain during rest, knee ROM, EQ-5D, OKS, and HSS.
","['patients after TKA', '100 patients with knee osteoarthritis (OA) prepared for TKA', 'patients after total knee arthroplasty']","['CBT or usual care group', 'Cognitive behavioral therapy (CBT', 'CBT program', 'CBT']","['PCS scores', 'pain, knee function, quality of life, and pain catastrophizing', 'lower pain during activity', 'pain during rest, knee ROM, EQ-5D, OKS, and HSS', 'Visual Analogue Scale (VAS), Pain Catastrophizing Scale (PCS), Oxford Knee Score (OKS), Knee Range of Motion (ROM), EuroQol Five-Dimensional (EQ-5D), and Hospital for Special Surgery (HSS) Knee Rating Scale', 'joint function', 'pain severity', 'mean VAS score during activity', 'pain of knee osteoarthritis (OA) and improving joint function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0576094', 'cui_str': 'Knee joint - range of movement'}, {'cui': 'C1997265', 'cui_str': 'Oxford knee score'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0542330', 'cui_str': 'Joint mobilization'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",100.0,0.0581903,"No statistically significantly differences between the two groups in pain during rest, knee ROM, EQ-5D, OKS, and HSS.
","[{'ForeName': 'Jian-Ning', 'Initials': 'JN', 'LastName': 'Sun', 'Affiliation': ""Department of Orthopaedic Surgery, Affiliated Hospital of Xuzhou Medical University, 99 Huaihai Road, Xuzhou, 221002, Jiangsu, People's Republic of China.""}, {'ForeName': 'Wang', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': ""Department of Orthopaedic Surgery, Affiliated Hospital of Xuzhou Medical University, 99 Huaihai Road, Xuzhou, 221002, Jiangsu, People's Republic of China.""}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Department of Orthopaedic Surgery, Affiliated Hospital of Xuzhou Medical University, 99 Huaihai Road, Xuzhou, 221002, Jiangsu, People's Republic of China.""}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Department of Orthopaedic Surgery, Affiliated Hospital of Xuzhou Medical University, 99 Huaihai Road, Xuzhou, 221002, Jiangsu, People's Republic of China.""}, {'ForeName': 'Shuo', 'Initials': 'S', 'LastName': 'Feng', 'Affiliation': ""Department of Orthopaedic Surgery, Affiliated Hospital of Xuzhou Medical University, 99 Huaihai Road, Xuzhou, 221002, Jiangsu, People's Republic of China. xzfs0561@163.com.""}, {'ForeName': 'Xiang-Yang', 'Initials': 'XY', 'LastName': 'Chen', 'Affiliation': ""Department of Orthopaedic Surgery, Affiliated Hospital of Xuzhou Medical University, 99 Huaihai Road, Xuzhou, 221002, Jiangsu, People's Republic of China. 781733181@qq.com.""}]",International orthopaedics,['10.1007/s00264-020-04767-8']
2407,32780139,"Effect of High Add Power, Medium Add Power, or Single-Vision Contact Lenses on Myopia Progression in Children: The BLINK Randomized Clinical Trial.","Importance


Slowing myopia progression could decrease the risk of sight-threatening complications.
Objective


To determine whether soft multifocal contact lenses slow myopia progression in children, and whether high add power (+2.50 D) slows myopia progression more than medium (+1.50 D) add power lenses.
Design, Setting, and Participants


A double-masked randomized clinical trial that took place at 2 optometry schools located in Columbus, Ohio, and Houston, Texas. A total of 294 consecutive eligible children aged 7 to 11 years with -0.75 D to -5.00 D of spherical component myopia and less than 1.00 D astigmatism were enrolled between September 22, 2014, and June 20, 2016. Follow-up was completed June 24, 2019.
Interventions


Participants were randomly assigned to wear high add power (n = 98), medium add power (n = 98), or single-vision (n = 98) contact lenses.
Main Outcomes and Measures


The primary outcome was the 3-year change in cycloplegic spherical equivalent autorefraction, as measured by the mean of 10 autorefraction readings. There were 11 secondary end points, 4 of which were analyzed for this study, including 3-year eye growth.
Results


Among 294 randomized participants, 292 (99%) were included in the analyses (mean [SD] age, 10.3 [1.2] years; 177 [60.2%] were female; mean [SD] spherical equivalent refractive error, -2.39 [1.00] D). Adjusted 3-year myopia progression was -0.60 D for high add power, -0.89 D for medium add power, and -1.05 D for single-vision contact lenses. The difference in progression was 0.46 D (95% CI, 0.29-0.63) for high add power vs single vision, 0.30 D (95% CI, 0.13-0.47) for high add vs medium add power, and 0.16 D (95% CI, -0.01 to 0.33) for medium add power vs single vision. Of the 4 secondary end points, there were no statistically significant differences between the groups for 3 of the end points. Adjusted mean eye growth was 0.42 mm for high add power, 0.58 mm for medium add power, and 0.66 mm for single vision. The difference in eye growth was -0.23 mm (95% CI, -0.30 to -0.17) for high add power vs single vision, -0.16 mm (95% CI, -0.23 to -0.09) for high add vs medium add power, and -0.07 mm (95% CI, -0.14 to -0.01) for medium add power vs single vision.
Conclusions and Relevance


Among children with myopia, treatment with high add power multifocal contact lenses significantly reduced the rate of myopia progression over 3 years compared with medium add power multifocal and single-vision contact lenses. However, further research is needed to understand the clinical importance of the observed differences.
Trial Registration


ClinicalTrials.gov Identifier: NCT02255474.",2020,"Adjusted 3-year myopia progression was -0.60 D for high add power, -0.89 D for medium add power, and -1.05 D for single-vision contact lenses.","['294 consecutive eligible children aged 7 to 11 years with -0.75 D to -5.00 D of spherical component myopia and less than 1.00 D astigmatism were enrolled between September 22, 2014, and June 20, 2016', 'Children', 'children with myopia', '294 randomized participants, 292 (99%) were included in the analyses (mean\u2009[SD] age, 10.3\u2009[1.2] years; 177 [60.2%] were female; mean [SD] spherical equivalent refractive error, -2.39']","['single-vision (n\u2009=\u200998) contact lenses', 'High Add Power, Medium Add Power, or Single-Vision Contact Lenses']","['rate of myopia progression', 'progression', '3-year eye growth', 'Adjusted 3-year myopia progression', '3-year change in cycloplegic spherical equivalent autorefraction, as measured by the mean of 10 autorefraction readings', 'eye growth']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4068882', 'cui_str': '0.75'}, {'cui': 'C0332501', 'cui_str': 'Spherical shape'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0027092', 'cui_str': 'Myopia'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0004106', 'cui_str': 'Astigmatism'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517519', 'cui_str': '10.3'}, {'cui': 'C4068880', 'cui_str': '1.2'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0034951', 'cui_str': 'Disorder of refraction'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0009836', 'cui_str': 'Contact lenses'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1275644', 'cui_str': 'Reading addition power'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}]","[{'cui': 'C0027092', 'cui_str': 'Myopia'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0010586', 'cui_str': 'Cycloplegic preparation'}, {'cui': 'C0332501', 'cui_str': 'Spherical shape'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0034754', 'cui_str': 'Reading'}]",294.0,0.396685,"Adjusted 3-year myopia progression was -0.60 D for high add power, -0.89 D for medium add power, and -1.05 D for single-vision contact lenses.","[{'ForeName': 'Jeffrey J', 'Initials': 'JJ', 'LastName': 'Walline', 'Affiliation': 'The Ohio State University College of Optometry; Columbus.'}, {'ForeName': 'Maria K', 'Initials': 'MK', 'LastName': 'Walker', 'Affiliation': 'University of Houston College of Optometry; Houston, Texas.'}, {'ForeName': 'Donald O', 'Initials': 'DO', 'LastName': 'Mutti', 'Affiliation': 'The Ohio State University College of Optometry; Columbus.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Jones-Jordan', 'Affiliation': 'The Ohio State University College of Optometry; Columbus.'}, {'ForeName': 'Loraine T', 'Initials': 'LT', 'LastName': 'Sinnott', 'Affiliation': 'The Ohio State University College of Optometry; Columbus.'}, {'ForeName': 'Amber Gaume', 'Initials': 'AG', 'LastName': 'Giannoni', 'Affiliation': 'University of Houston College of Optometry; Houston, Texas.'}, {'ForeName': 'Katherine M', 'Initials': 'KM', 'LastName': 'Bickle', 'Affiliation': 'The Ohio State University College of Optometry; Columbus.'}, {'ForeName': 'Krystal L', 'Initials': 'KL', 'LastName': 'Schulle', 'Affiliation': 'University of Houston College of Optometry; Houston, Texas.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Nixon', 'Affiliation': 'The Ohio State University College of Optometry; Columbus.'}, {'ForeName': 'Gilbert E', 'Initials': 'GE', 'LastName': 'Pierce', 'Affiliation': 'The Ohio State University College of Optometry; Columbus.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Berntsen', 'Affiliation': 'University of Houston College of Optometry; Houston, Texas.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2020.10834']
2408,32778472,"Letter to Editor ""Effects of handwriting exercise on functional outcome in Parkinson disease: A randomized controlled trial"".",,2020,,['Parkinson disease'],['handwriting exercise'],['functional outcome'],"[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}]","[{'cui': 'C0018582', 'cui_str': 'Handwriting'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.11164,,"[{'ForeName': 'Manpreet', 'Initials': 'M', 'LastName': 'Kaur', 'Affiliation': 'Department of Neuro-Physiotherapy, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (deemed to be University), Mullana, Ambala, Haryana 133207, India. Electronic address: priyuarora8427@gmail.com.'}, {'ForeName': 'Nidhi', 'Initials': 'N', 'LastName': 'Sharma', 'Affiliation': 'Department of Neuro-Physiotherapy, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (deemed to be University), Mullana, Ambala, Haryana 133207, India. Electronic address: sharma.nidhi.physio@mmumullana.org.'}, {'ForeName': 'Adarsh Kumar', 'Initials': 'AK', 'LastName': 'Srivastav', 'Affiliation': 'University Research Fellow, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (deemed to be University), Mullana, Ambala, Haryana 133207, India. Electronic address: adarsh.srivastav@mmumullana.org.'}]",Journal of clinical neuroscience : official journal of the Neurosurgical Society of Australasia,['10.1016/j.jocn.2020.06.020']
2409,32759258,Safety and tolerability of nintedanib in patients with systemic sclerosis-associated interstitial lung disease: data from the SENSCIS trial.,"OBJECTIVES


To characterise the safety and tolerability of nintedanib and the dose adjustments used to manage adverse events in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD).
METHODS


In the SENSCIS trial, patients with SSc-ILD were randomised to receive nintedanib 150 mg two times per day or placebo. To manage adverse events, treatment could be interrupted or the dose reduced to 100 mg two times per day. We assessed adverse events and dose adjustments over 52 weeks.
RESULTS


A total of 576 patients received nintedanib (n=288) or placebo (n=288). The most common adverse event was diarrhoea, reported in 75.7% of patients in the nintedanib group and 31.6% in the placebo group; diarrhoea led to permanent treatment discontinuation in 6.9% and 0.3% of patients in the nintedanib and placebo groups, respectively. In the nintedanib and placebo groups, respectively, 48.3% and 12.2% of patients had ≥1 dose reduction and/or treatment interruption, and adverse events led to permanent discontinuation of the trial drug in 16.0% and 8.7% of patients. The adverse events associated with nintedanib were similar across subgroups defined by age, sex, race and weight. The rate of decline in forced vital capacity in patients treated with nintedanib was similar irrespective of dose adjustments.
CONCLUSIONS


The adverse event profile of nintedanib in patients with SSc-ILD is consistent with its established safety and tolerability profile in patients with idiopathic pulmonary fibrosis. Dose adjustment is important to minimise the impact of adverse events and help patients remain on therapy.",2020,"The most common adverse event was diarrhoea, reported in 75.7% of patients in the nintedanib group and 31.6% in the placebo group; diarrhoea led to permanent treatment discontinuation in 6.9% and 0.3% of patients in the nintedanib and placebo groups, respectively.","['576 patients received nintedanib (n=288) or', 'patients with systemic sclerosis-associated interstitial lung disease', 'patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD', 'patients with SSc-ILD', 'patients with idiopathic pulmonary fibrosis']","['nintedanib', 'nintedanib 150\u2009mg two times per day or placebo', 'placebo']","['Safety and tolerability', 'safety and tolerability', 'diarrhoea', 'diarrhoea led to permanent treatment discontinuation', 'rate of decline in forced vital capacity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2930789', 'cui_str': 'nintedanib'}, {'cui': 'C0036421', 'cui_str': 'Systemic sclerosis'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0206062', 'cui_str': 'Interstitial lung disease'}, {'cui': 'C0036429', 'cui_str': 'Sclerosis'}, {'cui': 'C1800706', 'cui_str': 'Idiopathic pulmonary fibrosis'}]","[{'cui': 'C2930789', 'cui_str': 'nintedanib'}, {'cui': 'C3859348', 'cui_str': 'nintedanib 150 MG'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}]",576.0,0.200888,"The most common adverse event was diarrhoea, reported in 75.7% of patients in the nintedanib group and 31.6% in the placebo group; diarrhoea led to permanent treatment discontinuation in 6.9% and 0.3% of patients in the nintedanib and placebo groups, respectively.","[{'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Seibold', 'Affiliation': 'Scleroderma Research Consultants, LLC, Aiken, South Carolina, USA jamesrseibold@gmail.com.'}, {'ForeName': 'Toby M', 'Initials': 'TM', 'LastName': 'Maher', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'Kristin B', 'Initials': 'KB', 'LastName': 'Highland', 'Affiliation': 'Respiratory Institute, Cleveland Clinic, Cleveland, Ohio, USA.'}, {'ForeName': 'Shervin', 'Initials': 'S', 'LastName': 'Assassi', 'Affiliation': 'University of Texas Houston Medical School, Houston, Texas, USA.'}, {'ForeName': 'Arata', 'Initials': 'A', 'LastName': 'Azuma', 'Affiliation': 'Department of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Laura Kathleen', 'Initials': 'LK', 'LastName': 'Hummers', 'Affiliation': 'Division of Rheumatology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Costabel', 'Affiliation': 'Interstitial and Rare Lung Disease Unit, Department of Pneumology, Ruhrlandklinik, University Hospital Essen, Essen, Germany.'}, {'ForeName': 'Ute', 'Initials': 'U', 'LastName': 'von Wangenheim', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany.'}, {'ForeName': 'Veronika', 'Initials': 'V', 'LastName': 'Kohlbrenner', 'Affiliation': 'Boehringer Ingelheim Pharmaceuticals, Inc, Ridgefield, Connecticut, USA.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Gahlemann', 'Affiliation': 'Boehringer Ingelheim (Schweiz) GmbH, Basel, Switzerland.'}, {'ForeName': 'Margarida', 'Initials': 'M', 'LastName': 'Alves', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Distler', 'Affiliation': 'Department of Rheumatology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2020-217331']
2410,32763649,"Parenting, mental health and economic pathways to prevention of violence against children in South Africa.","BACKGROUND


Parenting programs based on social learning theory have increasing empirical evidence for reducing violence against children. Trials are primarily from high-income countries and with young children. Globally, we know little about how parenting programs work to reduce violence, with no known studies in low or middle-income countries (LMICs). This study examines mechanisms of change of a non-commercialized parenting program, Parenting for Lifelong Health for Teens, designed with the World Health Organization and UNICEF. A cluster randomized trial showed main effects on parenting and other secondary outcomes. We conducted secondary analysis of trial data to investigate five potential mediators of reduced violence against children: improved parenting, adolescent behaviour, caregiver mental health, alcohol/drug avoidance, and family economic strengthening.
METHODS


The trial was implemented in rural South Africa with 40 sites, n = 552 family dyads (including adolescents aged 10-18 and primary caregivers). Intervention sites (n = 20) received the 14-session parenting program delivered by local community members, including modules on family budgeting and savings. Control sites (n = 20) received a brief informational workshop. Emotional and physical violence against children/adolescents and each potential mediator were reported by adolescents and caregivers at baseline and 9-13 months post-randomisation. Structural equation modelling was used to test simultaneous hypothesized pathways to violence reduction.
RESULTS


Improvements in four pathways mediated reduced violence against children: 1) improved parenting practices, 2) improved caregiver mental health (reduced depression), 3) increased caregiver alcohol/drug avoidance and 4) improved family economic welfare. Improved child behaviour was not a mediator, although it was associated with less violence.
CONCLUSIONS


Simultaneously bolstering a set of family processes can reduce violence. Supporting self-care and positive coping for caregivers may be essential in challenging contexts. In countries with minimal or no economic safety nets, linking social learning parenting programs with economic strengthening skills may bring us closer to ending violence against children.",2020,"RESULTS


Improvements in four pathways mediated reduced violence against children: 1) improved parenting practices, 2) improved caregiver mental health (reduced depression), 3) increased caregiver alcohol/drug avoidance and 4) improved family economic welfare.","['rural South Africa with 40 sites, n\xa0=\xa0552 family dyads (including adolescents aged 10-18 and primary caregivers', 'reduced violence against children', 'Emotional and physical violence against children/adolescents', 'violence against children in South Africa', 'violence against children']","['brief informational workshop', '14-session parenting program delivered by local community members, including modules on family budgeting and savings']","['violence against children: 1) improved parenting practices, 2) improved caregiver mental health (reduced depression), 3) increased caregiver alcohol/drug avoidance and 4) improved family economic welfare', 'parenting, adolescent behaviour, caregiver mental health, alcohol/drug avoidance, and family economic strengthening', 'child behaviour']","[{'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1319883', 'cui_str': 'Primary caregiver'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0476480', 'cui_str': 'Physical violence'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0006347', 'cui_str': 'Budgets'}, {'cui': 'C0036245', 'cui_str': 'Savings'}]","[{'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0037440', 'cui_str': 'Social services'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",552.0,0.117351,"RESULTS


Improvements in four pathways mediated reduced violence against children: 1) improved parenting practices, 2) improved caregiver mental health (reduced depression), 3) increased caregiver alcohol/drug avoidance and 4) improved family economic welfare.","[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Cluver', 'Affiliation': 'Centre for Evidence-Based Intervention, Department of Social Policy & Intervention, University of Oxford, United Kingdom; Department of Psychiatry and Mental Health, University of Cape Town, South Africa. Electronic address: lucie.cluver@spi.ox.ac.uk.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Shenderovich', 'Affiliation': 'Centre for Evidence-Based Intervention, Department of Social Policy & Intervention, University of Oxford, United Kingdom; Institute of Criminology, University of Cambridge, United Kingdom. Electronic address: yulia.shenderovich@spi.ox.ac.uk.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Meinck', 'Affiliation': 'School of Social and Political Science, University of Edinburgh, United Kingdom; Optentia, Faculty of Health Sciences, North-West University, South Africa. Electronic address: Franziska.Meinck@ed.ac.uk.'}, {'ForeName': 'M N', 'Initials': 'MN', 'LastName': 'Berezin', 'Affiliation': 'Centre for Evidence-Based Intervention, Department of Social Policy & Intervention, University of Oxford, United Kingdom; Department of Applied Psychology, New York University, New York, USA. Electronic address: mnb387@nyu.edu.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Doubt', 'Affiliation': 'Centre for Evidence-Based Intervention, Department of Social Policy & Intervention, University of Oxford, United Kingdom. Electronic address: jennydoubt@gmail.com.'}, {'ForeName': 'C L', 'Initials': 'CL', 'LastName': 'Ward', 'Affiliation': 'Department of Psychology, University of Cape Town, South Africa. Electronic address: Catherine.Ward@uct.ac.za.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Parra-Cardona', 'Affiliation': 'Steve Hicks School of Social Work, The University of Texas at Austin, Texas, USA. Electronic address: rparra@austin.utexas.edu.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Lombard', 'Affiliation': 'Biostatistics Unit, South African Medical Research Council, South Africa. Electronic address: carl.lombard@mrc.ac.za.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Lachman', 'Affiliation': 'Centre for Evidence-Based Intervention, Department of Social Policy & Intervention, University of Oxford, United Kingdom; MRC/CSO Social and Public Health Sciences Unit, University of Glasglow, United Kingdom. Electronic address: jamie.lachman@spi.ox.ac.uk.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Wittesaele', 'Affiliation': 'Centre for Evidence-Based Intervention, Department of Social Policy & Intervention, University of Oxford, United Kingdom. Electronic address: camille.wittesaele@spi.ox.ac.uk.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Wessels', 'Affiliation': 'Centre for Evidence-Based Intervention, Department of Social Policy & Intervention, University of Oxford, United Kingdom; Department of Psychology, University of Cape Town, South Africa. Electronic address: inge.wessels@spi.ox.ac.uk.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Gardner', 'Affiliation': 'Centre for Evidence-Based Intervention, Department of Social Policy & Intervention, University of Oxford, United Kingdom. Electronic address: frances.gardner@wolfson.ox.ac.uk.'}, {'ForeName': 'J I', 'Initials': 'JI', 'LastName': 'Steinert', 'Affiliation': 'Centre for Evidence-Based Intervention, Department of Social Policy & Intervention, University of Oxford, United Kingdom; TUM School of Governance, Technical University of Munich, Germany. Electronic address: janina.steinert@tum.de.'}]",Social science & medicine (1982),['10.1016/j.socscimed.2020.113194']
2411,32768394,Impact of aerobic training with and without whole-body vibration training on metabolic features and quality of life in non-alcoholic fatty liver disease patients.,"The present study examined the effectiveness of adding exercises with whole-body vibration (WBV) to aerobic training in terms of metabolic features and quality of life. Patients with non-alcoholic fatty liver disease (NAFLD), confirmed on imaging, underwent an 8-week individualized exercise program randomized between aerobic training with and without WBV. Training was performed at 60-80% heart rate workload for 165 min/week. The WBV amplitude was 2-4mm and the training frequency was 30Hz, for 15min. Assessments were carried out on surrogate scores of steatosis and fibrosis including transient elastography (FibroScan), metabolic features (biochemical analysis) and quality of life (SF-36). Insulin resistance was markedly reduced (-2.36; 95% CI: -4.96 to -0.24; P: 0.049) in aerobic training with WBV. The decrease in serum aspartate transaminase was significantly greater in aerobic training without WBV (-14.81; 95% CI: -23.36 to -6.25; P: 0.029). There were no significant differences between groups for the other metabolic features (P<0.05). All quality of life well-being domains improved in both groups (P<0.05). Given this reduction in insulin resistance, WBV can usefully be added to aerobic training. However, WBV did not provide further benefits in improving metabolic properties or quality of life.",2020,The decrease in serum aspartate transaminase was significantly greater in aerobic training without WBV (-14.81; 95%CI: -23.36 to -6.25; P: 0.029).,"['non-alcoholic fatty liver disease patients', 'Patients with non-alcoholic fatty liver disease confirmed on imaging underwent an 8-week']","['exercises with whole-body vibration (WBV) to aerobic training', 'individualized exercise program randomized between aerobic training with and without WBV', 'aerobic training with and without whole-body vibration training']","['surrogate scores of steatosis and fibrosis including transient elastography (FibroScan), metabolic features (biochemical analysis) and quality of life (SF-36', 'metabolic features and quality of life', 'serum aspartate transaminase', 'WBV amplitude', 'Insulin resistance', 'metabolic properties or quality of life']","[{'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0152254', 'cui_str': 'Fatty degeneration'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2748260', 'cui_str': 'Transient elastography'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0871161', 'cui_str': 'Property'}]",,0.0409261,The decrease in serum aspartate transaminase was significantly greater in aerobic training without WBV (-14.81; 95%CI: -23.36 to -6.25; P: 0.029).,"[{'ForeName': 'Tülay', 'Initials': 'T', 'LastName': 'Çevik Saldiran', 'Affiliation': 'Department of physiotherapy and rehabilitation, faculty of health science, Bitlis Eren University, Ahmet-Eren boulevard, Rahva street, 13000 Bitlis, Turkey. Electronic address: tlyfztcvk@gmail.com.'}, {'ForeName': 'Fatma Karantay', 'Initials': 'FK', 'LastName': 'Mutluay', 'Affiliation': 'Department of physiotherapy and rehabilitation, Istanbul Medipol University, Istanbul, Turkey.'}, {'ForeName': 'İlker', 'Initials': 'İ', 'LastName': 'Yağci', 'Affiliation': 'Department of physical therapy and rehabilitation medicine, Marmara University, Istanbul, Istanbul, Turkey.'}, {'ForeName': 'Yusuf', 'Initials': 'Y', 'LastName': 'Yilmaz', 'Affiliation': 'Department of gastroenterology medicine, Marmara University, Istanbul, Istanbul, Turkey.'}]",Annales d'endocrinologie,['10.1016/j.ando.2020.05.003']
2412,32768792,The emotion regulatory function of online social networking: Preliminary experimental evidence.,"Correlational research suggests that emotion regulation deficits, which are known risk factors for substance addictions, may also play a role in the development of problem behaviors such as excessive or maladaptive use of social networking sites (SNS). This study sought to experimentally assess the hypothesized emotion regulatory function of SNS use. 139 undergraduates (53.2% female) were randomized to view brief movie clips known to reliably induce positive (37.4%), negative (29.5%), or neutral mood (33.1%) and then to browse a SNS (46.8%) or control website (53.2%). Mood and subjective urge to access SNS and the Internet were assessed before and after viewing the movie clips and browsing the websites. Participants meeting criteria for ""moderate"" levels of disordered SNS use self-reported significantly greater deficits in emotion regulation (p = .02, η p 2  = 0.14). Increases in positive and negative affect following the mood induction were associated with a decrease in subjective urge to access SNS (r = -0.22, p = .02, r = -0.28, p = .002, respectively). Time spent browsing SNS resulted in significantly greater increases in self-reported positive affect, compared to the control website (p = .001, η p 2  = 0.09). We replicate previous findings of greater emotion regulation deficits in individuals endorsing problematic SNS use. Increased positive and negative affect resulted in decreased urge to access SNS, suggesting that social networking may primarily serve to counter low-arousal emotions like boredom. Data provide initial experimental evidence to support the hypothesized emotion regulatory function of SNS, with SNS exposure resulting in increased positive affect. Findings suggest that interventions targeting problematic SNS use should incorporate strategies for improved emotion regulation.",2021,"Time spent browsing SNS resulted in significantly greater increases in self-reported positive affect, compared to the control website (p = .001, η p 2  = 0.09).","['individuals endorsing problematic SNS use', '139 undergraduates (53.2% female']",[],"['subjective urge to access SNS', 'deficits in emotion regulation']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3179002', 'cui_str': 'Social Networking'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]",[],"[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C3179002', 'cui_str': 'Social Networking'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}]",,0.0379552,"Time spent browsing SNS resulted in significantly greater increases in self-reported positive affect, compared to the control website (p = .001, η p 2  = 0.09).","[{'ForeName': 'Rae D', 'Initials': 'RD', 'LastName': 'Drach', 'Affiliation': 'Department of Psychology, University at Albany, State University of New York, United States.'}, {'ForeName': 'Natalia C', 'Initials': 'NC', 'LastName': 'Orloff', 'Affiliation': ""Department of Psychology, University at Albany, State University of New York, United States; Department of Child and Adolescent Psychiatry and Behavioral Sciences, Children's Hospital of Philadelphia, United States.""}, {'ForeName': 'Julia M', 'Initials': 'JM', 'LastName': 'Hormes', 'Affiliation': 'Department of Psychology, University at Albany, State University of New York, United States. Electronic address: jhormes@albany.edu.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106559']
2413,32779141,Daily Short Message Service Reminders Increase Treatment Compliance and Efficacy in Outpatients with Functional Dyspepsia: a Prospective Randomized Controlled Trial.,"BACKGROUND


Many outpatients with functional dyspepsia (FD) do not follow the medication schedule recommendations, which can lead to illness relapse.
OBJECTIVE


To investigate whether short message service (SMS) reminders improve medication regimen adherence and therapeutic efficacy in outpatients with FD.
DESIGN


Participants with FD were randomly allocated to the control group or intervention group. Patients in the control group received a 4-week medication treatment with no reminders, those in the intervention group received medication treatment plus a daily SMS reminder of dose and medication time.
PARTICIPANTS


Newly diagnosed FD patients from April 2019 to June 2019 were recruited from the GI outpatient clinics at Renji Hospital.
MEASUREMENTS


The scores for FD symptoms (LDQ) and psychological conditions (PHQ-9 for depression and GAD-7 for anxiety) were assessed before and after the treatment. The medication possession ratio (MPR) was calculated.
KEY RESULTS


A total of 352 eligible patients was enrolled in the study. The overall compliance rates of patients in the intervention and control groups were 87.5% and 80.7% in the intention-to-treat (ITT) analysis (P = 0.08) and 94.48% and 86.59% in per-protocol (PP) analysis (P = 0.015), respectively. In the intervention group, the compliance rate of younger patients (age ≤ 40 years) was significantly higher than that of age-matched patients in the control group (ITT: 86.1% vs. 70.5%, P = 0.018). Compared with the control group, the reduction in scores of LDQ (9.33 vs. 8.02, P = 0.017), PHQ-9 (6.97 vs. 5.69, P = 0.004), and GAD-7 (8.70 vs.7.53, P = 0.028) was significantly greater in patients receiving SMS reminders. The MPR of patients positively correlated with the reduction in scores of LDQ, PHQ-9, and GAD-7 in both groups.
CONCLUSIONS


SMS reminders can improve treatment compliance and efficacy in patients with FD.
TRIAL REGISTRATION


NCT04052750.",2020,"The MPR of patients positively correlated with the reduction in scores of LDQ, PHQ-9, and GAD-7 in both groups.
","['352 eligible patients was enrolled in the study', 'Outpatients with Functional Dyspepsia', 'outpatients with FD', 'Participants with FD', 'outpatients with functional dyspepsia (FD', 'patients with FD', 'Newly diagnosed FD patients from April 2019 to June 2019 were recruited from the GI outpatient clinics at Renji Hospital']","['short message service (SMS) reminders', 'control group or intervention group', '4-week medication treatment with no reminders, those in the intervention group received medication treatment plus a daily SMS reminder of dose and medication time', 'Daily Short Message Service Reminders']","['scores for FD symptoms (LDQ) and psychological conditions (PHQ-9 for depression and GAD-7 for anxiety', 'medication possession ratio (MPR', 'GAD-7', 'scores of LDQ', 'overall compliance rates', 'treatment compliance and efficacy', 'PHQ-9 ', 'scores of LDQ, PHQ-9, and GAD-7', 'compliance rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0267167', 'cui_str': 'Nonulcer dyspepsia'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C3469597', 'cui_str': 'Administration of medication'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0040223', 'cui_str': 'Time'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0267167', 'cui_str': 'Nonulcer dyspepsia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C3641330', 'cui_str': 'GAD-7'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C1321605', 'cui_str': 'Compliance behavior'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",352.0,0.0511439,"The MPR of patients positively correlated with the reduction in scores of LDQ, PHQ-9, and GAD-7 in both groups.
","[{'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Division of Gastroenterology and Hepatology, Renji Hospital, School of Medicine, Shanghai Institute of Digestive Disease, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Qing-Qing', 'Initials': 'QQ', 'LastName': 'Luo', 'Affiliation': 'Division of Gastroenterology and Hepatology, Renji Hospital, School of Medicine, Shanghai Institute of Digestive Disease, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Division of Gastroenterology and Hepatology, Renji Hospital, School of Medicine, Shanghai Institute of Digestive Disease, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Cheng', 'Affiliation': 'Division of Gastroenterology and Hepatology, Renji Hospital, School of Medicine, Shanghai Institute of Digestive Disease, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Sheng-Liang', 'Initials': 'SL', 'LastName': 'Chen', 'Affiliation': 'Division of Gastroenterology and Hepatology, Renji Hospital, School of Medicine, Shanghai Institute of Digestive Disease, Shanghai Jiao Tong University, Shanghai, China. chenslmd@163.com.'}]",Journal of general internal medicine,['10.1007/s11606-020-06088-3']
2414,30596265,Social Media Vaccine Websites: A Comparative Analysis of Public and Moderated Websites.,"The internet is an important source of vaccine information for parents. We evaluated and compared the interactive content on an expert moderated vaccine social media (VSM) website developed for parents of children 24 months of age or younger and enrolled in a health care system to a random sample of interactions extracted from publicly available parenting and vaccine-focused blogs and discussion forums. The study observation period was September 2013 through July 2016. Three hundred sixty-seven eligible websites were located using search terms related to vaccines. Seventy-nine samples of interactions about vaccines on public blogs and discussion boards and 61 interactions from the expert moderated VSM website were coded for tone, vaccine stance, and accuracy of information. If information was inaccurate, it was coded as corrected, partially corrected or uncorrected. Using chi-square or Fisher's exact tests, we compared coded interactions from the VSM website with coded interactions from the sample of publicly available websites. We then identified representative quotes to illustrate the quantitative results. Tone, vaccine stance, and accuracy of information were significantly different (all p < .05). Publicly available vaccine websites tended to be more contentious and have a negative stance toward vaccines. These websites also had inaccurate and uncorrected information. In contrast, the expert moderated website had a more civil tone, minimal posting of inaccurate information, with very little participant-to-participant interaction. An expert moderated, interactive vaccine website appears to provide a platform for parents to gather accurate vaccine information, express their vaccine concerns and ask questions of vaccine experts.",2019,"Tone, vaccine stance, and accuracy of information were significantly different (all p < .05).","['parents', 'Three hundred sixty-seven eligible websites', 'parents of children 24 months of age or younger and enrolled in a health care system to a random sample of interactions extracted from publicly available parenting and vaccine-focused blogs and discussion forums']","['expert moderated vaccine social media (VSM) website', 'Social Media Vaccine Websites']","['Tone, vaccine stance, and accuracy of information']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C4517852', 'cui_str': '67'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0018696', 'cui_str': 'Healthcare Systems'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C2718045', 'cui_str': 'Blogs as Topic'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}]",,0.026545,"Tone, vaccine stance, and accuracy of information were significantly different (all p < .05).","[{'ForeName': 'Jo Ann', 'Initials': 'JA', 'LastName': 'Shoup', 'Affiliation': '1 Kaiser Permanente Colorado, Denver, CO, USA.'}, {'ForeName': 'Komal J', 'Initials': 'KJ', 'LastName': 'Narwaney', 'Affiliation': '1 Kaiser Permanente Colorado, Denver, CO, USA.'}, {'ForeName': 'Nicole M', 'Initials': 'NM', 'LastName': 'Wagner', 'Affiliation': '1 Kaiser Permanente Colorado, Denver, CO, USA.'}, {'ForeName': 'Courtney R', 'Initials': 'CR', 'LastName': 'Kraus', 'Affiliation': '1 Kaiser Permanente Colorado, Denver, CO, USA.'}, {'ForeName': 'Kathy S', 'Initials': 'KS', 'LastName': 'Gleason', 'Affiliation': '1 Kaiser Permanente Colorado, Denver, CO, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Albright', 'Affiliation': '2 University of Denver, Denver, CO, USA.'}, {'ForeName': 'Jason M', 'Initials': 'JM', 'LastName': 'Glanz', 'Affiliation': '1 Kaiser Permanente Colorado, Denver, CO, USA.'}]",Health education & behavior : the official publication of the Society for Public Health Education,['10.1177/1090198118818253']
2415,32759361,"Reducing Inpatient Hypoglycemia in the General Wards Using Real-time Continuous Glucose Monitoring: The Glucose Telemetry System, a Randomized Clinical Trial.","OBJECTIVE


Use of real-time continuous glucose monitoring (RT-CGM) systems in the inpatient setting is considered investigational. The objective of this study was to evaluate whether RT-CGM, using the glucose telemetry system (GTS), can prevent hypoglycemia in the general wards.
RESEARCH DESIGN AND METHODS


In a randomized clinical trial, insulin-treated patients with type 2 diabetes at high risk for hypoglycemia were recruited. Participants were randomized to RT-CGM/GTS or point-of-care (POC) blood glucose testing. The primary outcome was difference in inpatient hypoglycemia.
RESULTS


Seventy-two participants were included in this interim analysis, 36 in the RT-CGM/GTS group and 36 in the POC group. The RT-CGM/GTS group experienced fewer hypoglycemic events (<70 mg/dL) per patient (0.67 [95% CI 0.34-1.30] vs. 1.69 [1.11-2.58],  P  = 0.024), fewer clinically significant hypoglycemic events (<54 mg/dL) per patient (0.08 [0.03-0.26] vs. 0.75 [0.51-1.09],  P  = 0.003), and a lower percentage of time spent below range <70 mg/dL (0.40% [0.18-0.92%] vs. 1.88% [1.26-2.81%],  P  = 0.002) and <54 mg/dL (0.05% [0.01-0.43%] vs. 0.82% [0.47-1.43%],  P  = 0.017) compared with the POC group. No differences in nocturnal hypoglycemia, time in range 70-180 mg/dL, and time above range >180-250 mg/dL and >250 mg/dL were found between the groups. The RT-CGM/GTS group had no prolonged hypoglycemia compared with 0.20 episodes <54 mg/dL and 0.40 episodes <70 mg/dL per patient in the POC group.
CONCLUSIONS


RT-CGM/GTS can decrease hypoglycemia among hospitalized high-risk insulin-treated patients with type 2 diabetes.",2020,"The RT-CGM/GTS group experienced fewer hypoglycemic events (<70 mg/dL) per patient (0.67 [95% CI 0.34-1.30] vs. 1.69 [1.11-2.58],  P  = 0.024), fewer clinically significant hypoglycemic events (<54 mg/dL) per patient (0.08 [0.03-0.26] vs. 0.75 [0.51-1.09],  P  = 0.003), and a lower percentage of time spent below range <70 mg/dL (0.40% [0.18-0.92%] vs. 1.88% [1.26-2.81%],  P  = 0.002) and <54 mg/dL (0.05% [0.01-0.43%] vs. 0.82% [0.47-1.43%],  P  = 0.017) compared with the POC group.","['treated patients with type 2 diabetes at high risk for hypoglycemia were recruited', 'Seventy-two participants were included in this interim analysis, 36 in the RT-CGM/GTS group and 36 in the POC group']","['RT-CGM', 'RT-CGM/GTS or point-of-care (POC) blood glucose testing', 'insulin', 'RT-CGM/GTS', 'glucose telemetry system (GTS', 'real-time continuous glucose monitoring (RT-CGM']","['nocturnal hypoglycemia', 'hypoglycemia', 'inpatient hypoglycemia', 'prolonged hypoglycemia', 'Inpatient Hypoglycemia', 'hypoglycemic events']","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C4319632', 'cui_str': '72'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0039451', 'cui_str': 'Telemetry'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0282664', 'cui_str': 'Point-of-Care'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0039451', 'cui_str': 'Telemetry'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0282664', 'cui_str': 'Point-of-Care'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}]","[{'cui': 'C0342315', 'cui_str': 'Nocturnal hypoglycemia'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",72.0,0.0730647,"The RT-CGM/GTS group experienced fewer hypoglycemic events (<70 mg/dL) per patient (0.67 [95% CI 0.34-1.30] vs. 1.69 [1.11-2.58],  P  = 0.024), fewer clinically significant hypoglycemic events (<54 mg/dL) per patient (0.08 [0.03-0.26] vs. 0.75 [0.51-1.09],  P  = 0.003), and a lower percentage of time spent below range <70 mg/dL (0.40% [0.18-0.92%] vs. 1.88% [1.26-2.81%],  P  = 0.002) and <54 mg/dL (0.05% [0.01-0.43%] vs. 0.82% [0.47-1.43%],  P  = 0.017) compared with the POC group.","[{'ForeName': 'Lakshmi G', 'Initials': 'LG', 'LastName': 'Singh', 'Affiliation': 'Division of Endocrinology, Baltimore Veterans Affairs Medical Center, Baltimore, MD.'}, {'ForeName': 'Medha', 'Initials': 'M', 'LastName': 'Satyarengga', 'Affiliation': 'Center for Diabetes and Endocrinology, University of Maryland Shore Regional Health, Easton, MD.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Marcano', 'Affiliation': 'Division of Endocrinology, Diabetes, and Nutrition, University of Maryland School of Medicine, Baltimore, MD.'}, {'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Scott', 'Affiliation': 'Division of Endocrinology, Baltimore Veterans Affairs Medical Center, Baltimore, MD.'}, {'ForeName': 'Lillian F', 'Initials': 'LF', 'LastName': 'Pinault', 'Affiliation': 'Division of Endocrinology, Baltimore Veterans Affairs Medical Center, Baltimore, MD.'}, {'ForeName': 'Zhaoyong', 'Initials': 'Z', 'LastName': 'Feng', 'Affiliation': 'Pharmaceutical Research Computing, Department of Pharmaceutical Health Services Research, University of Maryland School of Pharmacy, Baltimore, MD.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Sorkin', 'Affiliation': 'Baltimore Veterans Affairs Medical Center Geriatric Research, Education, and Clinical Center, Baltimore, MD.'}, {'ForeName': 'Guillermo E', 'Initials': 'GE', 'LastName': 'Umpierrez', 'Affiliation': 'Division of Endocrinology, Metabolism, and Lipids, Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Elias K', 'Initials': 'EK', 'LastName': 'Spanakis', 'Affiliation': 'Division of Endocrinology, Baltimore Veterans Affairs Medical Center, Baltimore, MD ispanakis@som.umaryland.edu.'}]",Diabetes care,['10.2337/dc20-0840']
2416,32772244,"Isokinetic eccentric exercise substantially improves mobility, muscle strength and size, but not postural sway metrics in older adults, with limited regression observed following a detraining period.","INTRODUCTION


Eccentric exercise can reverse age-related decreases in muscle strength and mass; however, no data exist describing its effects on postural sway. As the ankle may be more important for postural sway than hip and knee joints, and with older adults prone to periods of inactivity, the effects of two 6-week seated isokinetic eccentric exercise programmes, and an 8-week detraining period, were examined in 27 older adults (67.1 ± 6.0 years).
METHODS


Neuromuscular parameters were measured before and after training and detraining periods with subjects assigned to ECC (twice-weekly eccentric-only hip and knee extensor contractions) or ECC PF  (identical training with additional eccentric-only plantarflexor contractions) training programmes.
RESULTS


Significant (P < 0.05) increases in mobility (decreased timed-up-and-go time [- 7.7 to - 12.0%]), eccentric strength (39.4-58.8%) and vastus lateralis thickness (9.8-9.9%) occurred after both training programmes, with low-to-moderate weekly rate of perceived exertion (3.3-4.5/10) reported. No significant change in any postural sway metric occurred after either training programme. After 8 weeks of detraining, mobility (- 8.2 to - 11.3%), eccentric strength (30.5-50.4%) and vastus lateralis thickness (6.1-7.1%) remained significantly greater than baseline in both groups.
CONCLUSION


Despite improvements in functional mobility, muscle strength and size, lower-limb eccentric training targeting hip, knee and ankle extensor muscle groups was not sufficient to influence static balance. Nonetheless, as the beneficial functional and structural adaptations were largely maintained through an 8-week detraining period, these findings have important implications for clinical exercise prescription as the exercise modality, low perceived training intensity, and adaptive profile are well suited to the needs of older adults.",2020,", lower-limb eccentric training targeting hip, knee and ankle extensor muscle groups was not sufficient to influence static balance.","['27 older adults (67.1\u2009±\u20096.0 years', 'older adults']","['Eccentric exercise', 'seated isokinetic eccentric exercise programmes', 'ECC (twice-weekly eccentric-only hip and knee extensor contractions) or ECC PF  (identical training with additional eccentric-only plantarflexor contractions) training programmes', 'Isokinetic eccentric exercise']","['postural sway metric', 'vastus lateralis thickness', 'mobility, muscle strength and size, but not postural sway metrics', 'functional mobility, muscle strength and size', 'mobility', 'eccentric strength']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0439740', 'cui_str': 'Eccentric'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0277814', 'cui_str': 'Sitting position'}, {'cui': 'C4077283', 'cui_str': '67Ga-ethylenecysteamine cysteine'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0439740', 'cui_str': 'Eccentric'}]",27.0,0.0138365,", lower-limb eccentric training targeting hip, knee and ankle extensor muscle groups was not sufficient to influence static balance.","[{'ForeName': 'Anthony David', 'Initials': 'AD', 'LastName': 'Kay', 'Affiliation': 'Centre for Physical Activity and Life Sciences, Faculty of Art, Science and Technology, University of Northampton, Northamptonshire, UK. tony.kay@northampton.ac.uk.'}, {'ForeName': 'Anthony John', 'Initials': 'AJ', 'LastName': 'Blazevich', 'Affiliation': 'Centre for Exercise and Sports Science Research (CESSR), School of Exercise and Health Sciences, Edith Cowan University, Joondalup, Australia.'}, {'ForeName': 'Millie', 'Initials': 'M', 'LastName': 'Fraser', 'Affiliation': 'Centre for Physical Activity and Life Sciences, Faculty of Art, Science and Technology, University of Northampton, Northamptonshire, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Ashmore', 'Affiliation': 'Centre for Physical Activity and Life Sciences, Faculty of Art, Science and Technology, University of Northampton, Northamptonshire, UK.'}, {'ForeName': 'Mathew William', 'Initials': 'MW', 'LastName': 'Hill', 'Affiliation': 'Centre for Sport, Exercise and Life Sciences, School of Life Sciences, Coventry University, Warwickshire, UK.'}]",European journal of applied physiology,['10.1007/s00421-020-04466-7']
2417,32775825,Supervised Exercise Intervention and Overall Activity in CKD.,"Introduction


Patients are often instructed to engage in multiple weekly sessions of exercise to increase physical activity. We aimed to determine whether assignment to a supervised exercise regimen increases overall weekly activity in individuals with chronic kidney disease (CKD).
Methods


We performed a secondary analysis of a pilot randomized 2 × 2 factorial design trial examining the effects of diet and exercise (10%-15% reduction in caloric intake, 3 supervised exercise sessions/wk, combined diet restriction/exercise, and control). Activity was measured as counts detected by accelerometer. Counts data were collected on all days for which an accelerometer was worn at baseline, month 2, and month 4 follow-up. The primary outcome was a relative change from baseline in log-transformed counts/min. Generalized estimating equations were used to compare the primary outcome in individuals in the exercise group and the nonexercise group.
Results


We examined 111 individuals randomized to aerobic exercise or usual activity (n = 48 in the exercise group and n = 44 controls). The mean age was 57 years, 42% were female, and 28% were black. Median overall adherence over all time was 73%. Median (25th, 75th percentile) counts/min over nonsupervised exercise days at months 2 and 4 were 237.5 (6.5, 444.4) for controls and 250.9 (7.7, 529.8) for the exercise group ( P  = 0.74). No difference was observed in the change in counts/min between the exercise and control groups over 3 time points (β [fold change], 0.96, 95% confidence interval [CI], 0.91, 1.02).
Conclusion


Engaging in a supervised exercise program does not increase overall weekly physical activity in individuals with stage 3 to 4 CKD.",2020,"No difference was observed in the change in counts/min between the exercise and control groups over 3 time points (β [fold change], 0.96, 95% confidence interval [CI], 0.91, 1.02).
","['individuals with stage 3 to 4 CKD', '111 individuals randomized to', 'individuals with chronic kidney disease (CKD', 'The mean age was 57 years, 42% were female, and 28% were black', 'n\xa0= 48 in the exercise group and n\xa0= 44 controls']","['diet and exercise', 'aerobic exercise or usual activity', 'supervised exercise regimen', 'supervised exercise program', 'Supervised Exercise Intervention']","['Activity', 'relative change from baseline in log-transformed counts/min', 'Median overall adherence', 'overall weekly physical activity']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",111.0,0.116624,"No difference was observed in the change in counts/min between the exercise and control groups over 3 time points (β [fold change], 0.96, 95% confidence interval [CI], 0.91, 1.02).
","[{'ForeName': 'Mindy M', 'Initials': 'MM', 'LastName': 'Pike', 'Affiliation': ""Vanderbilt O'Brien Kidney Center, Division of Nephrology and Hypertension, Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA.""}, {'ForeName': 'Aseel', 'Initials': 'A', 'LastName': 'Alsouqi', 'Affiliation': ""Vanderbilt O'Brien Kidney Center, Division of Nephrology and Hypertension, Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA.""}, {'ForeName': 'Samuel A E', 'Initials': 'SAE', 'LastName': 'Headley', 'Affiliation': 'Department of Exercise Science and Athletic Training, Springfield College, Springfield, Massachusetts, USA.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Tuttle', 'Affiliation': 'Kidney Research Institute, Division of Nephrology, Department of Medicine, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Elizabeth Elspeth', 'Initials': 'EE', 'LastName': 'Evans', 'Affiliation': 'Department of Exercise Science and Athletic Training, Springfield College, Springfield, Massachusetts, USA.'}, {'ForeName': 'Charles M', 'Initials': 'CM', 'LastName': 'Milch', 'Affiliation': 'Department of Exercise Science and Athletic Training, Springfield College, Springfield, Massachusetts, USA.'}, {'ForeName': 'Kelsey Anne', 'Initials': 'KA', 'LastName': 'Moody', 'Affiliation': 'Department of Exercise Science and Athletic Training, Springfield College, Springfield, Massachusetts, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Germain', 'Affiliation': 'Department of Nephrology, Bay State Medical Center, Springfield, Massachusetts, USA.'}, {'ForeName': 'Thomas G', 'Initials': 'TG', 'LastName': 'Stewart', 'Affiliation': 'Department of Biostatistics, Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Loren', 'Initials': 'L', 'LastName': 'Lipworth', 'Affiliation': ""Vanderbilt O'Brien Kidney Center, Division of Nephrology and Hypertension, Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA.""}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Himmelfarb', 'Affiliation': 'Kidney Research Institute, Division of Nephrology, Department of Medicine, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'T Alp', 'Initials': 'TA', 'LastName': 'Ikizler', 'Affiliation': ""Vanderbilt O'Brien Kidney Center, Division of Nephrology and Hypertension, Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA.""}, {'ForeName': 'Cassianne', 'Initials': 'C', 'LastName': 'Robinson-Cohen', 'Affiliation': ""Vanderbilt O'Brien Kidney Center, Division of Nephrology and Hypertension, Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA.""}]",Kidney international reports,['10.1016/j.ekir.2020.06.006']
2418,32777710,Community-level interventions for pre-eclampsia (CLIP) in Pakistan: A cluster randomised controlled trial.,"OBJECTIVES


To reduce all-cause maternal and perinatal mortality and major morbidity through Lady Health Worker (LHW)-facilitated community engagement and early diagnosis, stabilization and referral of women with preeclampsia, an important contributor to adverse maternal and perinatal outcomes given delays in early detection and initial management.
STUDY DESIGN


In the Pakistan Community-Level Interventions for Pre-eclampsia (CLIP) cluster randomized controlled trial (NCT01911494), LHWs engaged the community, recruited pregnant women from 20 union councils (clusters), undertook mobile health-guided clinical assessment for preeclampsia, and referral to facilities after stabilization.
MAIN OUTCOME MEASURES


The primary outcome was a composite of maternal, fetal and newborn mortality and major morbidity.
FINDINGS


We recruited 39,446 women in intervention (N = 20,264) and control clusters (N = 19,182) with minimal loss to follow-up (3∙7% vs. 4∙5%, respectively). The primary outcome did not differ between intervention (26·6%) and control (21·9%) clusters (adjusted odds ratio, aOR, 1∙20 [95% confidence interval 0∙84-1∙72]; p = 0∙31). There was reduction in stillbirths (0·89 [0·81-0·99]; p = 0·03), but no impact on maternal death (1·08 [0·69, 1·71]; p = 0·74) or morbidity (1·12 [0·57, 2·16]; p = 0·77); early (0·95 [0·82-1·09]; p = 0·46) or late neonatal deaths (1·23 [0·97-1·55]; p = 0·09); or neonatal morbidity (1·22 [0·77, 1·96]; p = 0·40). Improvements in outcome rates were observed with 4-7 (p = 0·015) and ≥8 (p < 0·001) (vs. 0) CLIP contacts.
INTERPRETATION


The CLIP intervention was well accepted by the community and implemented by LHWs. Lack of effects on adverse outcomes could relate to quality care for mothers with pre-eclampsia in health facilities. Future strategies for community outreach must also be accompanied by health facility strengthening.
FUNDING


The University of British Columbia (PRE-EMPT), a grantee of the Bill & Melinda Gates Foundation (OPP1017337).",2020,"There was reduction in stillbirths (0·89 [0·81-0·99]; p = 0·03), but no impact on maternal death (1·08 [0·69, 1·71]; p = 0·74) or morbidity (1·12 [0·57, 2·16]; p = 0·77);","['39,446 women in intervention (N\xa0=\xa020,264) and control clusters (N\xa0=\xa019,182) with minimal loss to follow-up (3∙7% vs. 4∙5%, respectively', 'mothers with pre-eclampsia in health facilities', 'recruited pregnant women from 20 union councils (clusters), undertook mobile health-guided clinical assessment for preeclampsia, and referral to facilities after stabilization', 'pre-eclampsia (CLIP) in Pakistan', 'women with preeclampsia']","['Community-level interventions', 'CLIP intervention']","['late neonatal deaths', 'neonatal morbidity', 'outcome rates', 'maternal death', 'reduction in stillbirths', 'composite of maternal, fetal and newborn mortality and major morbidity']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}]","[{'cui': 'C0455987', 'cui_str': 'Late neonatal death'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0024923', 'cui_str': 'Maternal death'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0595939', 'cui_str': 'Stillbirth'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0027616', 'cui_str': 'Neonatal Mortality'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",39446.0,0.261501,"There was reduction in stillbirths (0·89 [0·81-0·99]; p = 0·03), but no impact on maternal death (1·08 [0·69, 1·71]; p = 0·74) or morbidity (1·12 [0·57, 2·16]; p = 0·77);","[{'ForeName': 'Rahat N', 'Initials': 'RN', 'LastName': 'Qureshi', 'Affiliation': 'Centre of Excellence, Division of Woman and Child Health, Aga Khan University, Stadium Road, P. O. Box 3500, Karachi 74800, Pakistan.'}, {'ForeName': 'Sana', 'Initials': 'S', 'LastName': 'Sheikh', 'Affiliation': 'Centre of Excellence, Division of Woman and Child Health, Aga Khan University, Stadium Road, P. O. Box 3500, Karachi 74800, Pakistan.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Hoodbhoy', 'Affiliation': 'Centre of Excellence, Division of Woman and Child Health, Aga Khan University, Stadium Road, P. O. Box 3500, Karachi 74800, Pakistan.'}, {'ForeName': 'Sumedha', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Vidler', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada; Centre for International Child Health, University of British Columbia, 305-4088 Cambie Street, Vancouver, BC V5Z 2X8, Canada.'}, {'ForeName': 'Beth A', 'Initials': 'BA', 'LastName': 'Payne', 'Affiliation': 'Centre for International Child Health, University of British Columbia, 305-4088 Cambie Street, Vancouver, BC V5Z 2X8, Canada.'}, {'ForeName': 'Imran', 'Initials': 'I', 'LastName': 'Ahmed', 'Affiliation': 'Centre of Excellence, Division of Woman and Child Health, Aga Khan University, Stadium Road, P. O. Box 3500, Karachi 74800, Pakistan.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Mark Ansermino', 'Affiliation': 'Centre for International Child Health, University of British Columbia, 305-4088 Cambie Street, Vancouver, BC V5Z 2X8, Canada.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Bone', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada.'}, {'ForeName': 'Dustin T', 'Initials': 'DT', 'LastName': 'Dunsmuir', 'Affiliation': 'Centre for International Child Health, University of British Columbia, 305-4088 Cambie Street, Vancouver, BC V5Z 2X8, Canada.'}, {'ForeName': 'Tang', 'Initials': 'T', 'LastName': 'Lee', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada.'}, {'ForeName': 'Hannah L', 'Initials': 'HL', 'LastName': 'Nathan', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Medicine and Life Sciences, King's College London, 1 Lambeth Palace Road, London SE1 7EH, UK.""}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Shennan', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Medicine and Life Sciences, King's College London, 1 Lambeth Palace Road, London SE1 7EH, UK.""}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Singer', 'Affiliation': ""Centre for Health Evaluation and Outcome Sciences, Providence Health Care Research Institute, University of British Columbia, 588 - 1081 Burrard Street, St. Paul's Hospital, Vancouver, BC V6Z 1Y6, Canada.""}, {'ForeName': 'Domena K', 'Initials': 'DK', 'LastName': 'Tu', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada.'}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Wong', 'Affiliation': ""Centre for Health Evaluation and Outcome Sciences, Providence Health Care Research Institute, University of British Columbia, 588 - 1081 Burrard Street, St. Paul's Hospital, Vancouver, BC V6Z 1Y6, Canada.""}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Magee', 'Affiliation': ""Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada; Department of Women and Children's Health, School of Life Course Sciences, Faculty of Medicine and Life Sciences, King's College London, 1 Lambeth Palace Road, London SE1 7EH, UK.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'von Dadelszen', 'Affiliation': ""Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada; Department of Women and Children's Health, School of Life Course Sciences, Faculty of Medicine and Life Sciences, King's College London, 1 Lambeth Palace Road, London SE1 7EH, UK.""}, {'ForeName': 'Zulfiqar A', 'Initials': 'ZA', 'LastName': 'Bhutta', 'Affiliation': 'Centre of Excellence, Division of Woman and Child Health, Aga Khan University, Stadium Road, P. O. Box 3500, Karachi 74800, Pakistan; Centre for Global Child Health, Hospital for Sick Children, 525 University Avenue, Suite 702, Toronto, ON M5G 2L3, Canada. Electronic address: zulfiqar.bhutta@aku.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': 'the CLIP Pakistan Trial Working Group (Table S1).'}]",Pregnancy hypertension,['10.1016/j.preghy.2020.07.011']
2419,32777737,Evaluation of efficacy and safety of rituximab in combination with mycophenolate mofetil in patients with nonspecific interstitial pneumonia non-responding to a first-line immunosuppressive treatment (EVER-ILD): A double-blind placebo-controlled randomized trial.,"INTRODUCTION


Nonspecific interstitial pneumonia (NSIP) are rare but severe diseases, with high mortality and morbidity, with no effective pharmacological treatment allowing for long-term remission, and therefore no clear therapeutic recommendations. Classic immunosuppressants are used as first-line treatment, with only one third of patients being responders and no clear recommendations exist for the choice of the second-line therapy. The EvER-ILD study is the first one to prospectively evaluate the efficacy and safety of rituximab and mycophenolate mofetil (MMF) versus placebo and MMF in a broad range of NSIP patients that did not respond to a first-line therapy. A pharmacokinetic-pharmacodynamic analysis based on rituximab serum concentrations will allow identification of potential factors associated with therapeutic response and/or adverse effects.
METHODS


EvER-ILD study is a French multicenter, prospective, randomized, double blind, placebo-controlled, superiority trial. Patients with severe and progressive NSIP non-responding to a first line immunosuppressive treatment will be randomized in 2 groups of treatment: one course of rituximab plus 6 months MMF (RTX-MMF group) and one course of placebo plus 6 months MMF (Placebo-MMF group). The primary outcome is the change in Forced Vital Capacity (FVC, % of predicted) from baseline to 6 months. Several clinical, biological, and quality of life secondary outcomes will be measured at 3, 6 and 12 months. A sample size of 122 patients (61 patients per group) would allow to show a point difference between groups in the change of FVC at 6 months, based on a common standard deviation for FVC change of 8% with a power of 90%, alpha 5% two-sided, and anticipating an extreme 10% drop-out rate.
ETHICS AND DISSEMINATION


The protocol was approved by the French Research Ethics Committee (CPP Tours Ouest 1 2016-R28) on November 10, 2016, and by the French competent authority (ANSM, reference 160771A-22) on December 1st, 2016. This article refers to protocol V2, dated November 18, 2016. An independent data safety monitoring board will review safety and tolerability data for the duration of the trial. Results will be disseminated via peer reviewed publication and presentation at international conferences.
TRIAL REGISTRATION NUMBER


NCT02990286 (clinicaltrials.gov), EudraCT 2016-003026-16 (European Medicines agency).",2020,"The primary outcome is the change in Forced Vital Capacity (FVC, % of predicted) from baseline to 6 months.","['2016-003026-16 (European Medicines agency', '122 patients (61 patients per group', 'patients with nonspecific interstitial pneumonia non-responding to a first-line immunosuppressive treatment (EVER-ILD', 'Patients with severe and progressive NSIP non-responding to a first line immunosuppressive treatment']","['EudraCT', 'mycophenolate mofetil', 'rituximab and mycophenolate mofetil (MMF) versus placebo and MMF', 'rituximab plus 6 months MMF (RTX-MMF group) and one course of placebo plus 6 months MMF (Placebo-MMF group', 'rituximab', 'placebo']","['change in Forced Vital Capacity (FVC, % of predicted']","[{'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1290344', 'cui_str': 'Nonspecific interstitial pneumonia'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0021081', 'cui_str': 'Immunosuppressant agent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0206062', 'cui_str': 'Interstitial lung disease'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}]","[{'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0073081', 'cui_str': 'resiniferatoxin'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0750729', 'cui_str': 'Courses'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C3714541', 'cui_str': 'Forced vital capacity'}]",,0.378227,"The primary outcome is the change in Forced Vital Capacity (FVC, % of predicted) from baseline to 6 months.","[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Bejan-Angoulvant', 'Affiliation': 'Service de Pharmacologie médicale, CHRU de Tours, Hôpital Bretonneau, Université de Tours, Tours, France.'}, {'ForeName': 'J-Marc', 'Initials': 'JM', 'LastName': 'Naccache', 'Affiliation': 'AP-HP, Hôpital Tenon, service de pneumologie, Site constitutif du centre de référence pour les maladies pulmonaires rares OrphaLung, and Sorbonne Université, Paris, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Caille', 'Affiliation': 'Inserm CIC1415, CHRU Tours, Université de Tours, Université de Nantes, SPHERE, U1246, Tours, France.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Borie', 'Affiliation': 'AP-HP, service de pneumologie, centre de compétences pour les maladies pulmonaires rares, Hôpital Bichat, Paris, France.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Nunes', 'Affiliation': 'Service de pneumologie, centre constitutif pour les maladies pulmonaires rares, hôpital Avicenne, CHU Paris Seine-Saint-Denis, Bobigny, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ferreira', 'Affiliation': 'Service de Pneumologie, CHRU de Tours, Centre de compétences des maladies pulmonaires rares de la région Centre, Hôpital Bretonneau, Tours, France; Université de Tours, CEPR Inserm U1100, Tours, France.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Cadranel', 'Affiliation': 'AP-HP, Hôpital Tenon, service de pneumologie, Site constitutif du centre de référence pour les maladies pulmonaires rares OrphaLung, and Sorbonne Université, Paris, France.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Crestani', 'Affiliation': 'AP-HP, service de pneumologie, centre de compétences pour les maladies pulmonaires rares, Hôpital Bichat, Paris, France.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Cottin', 'Affiliation': 'Service de Pneumologie, Centre national coordonnateur de référence des maladies pulmonaires rares, Hôpital Louis Pradel, Hospices civils de Lyon, UMR 754, Université Claude Bernard Lyon 1, Lyon, France.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Marchand-Adam', 'Affiliation': 'Service de Pneumologie, CHRU de Tours, Centre de compétences des maladies pulmonaires rares de la région Centre, Hôpital Bretonneau, Tours, France; Université de Tours, CEPR Inserm U1100, Tours, France. Electronic address: s.marchandadam@univ-tours.fr.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Respiratory medicine and research,['10.1016/j.resmer.2020.100770']
2420,32785213,Phase I/II study of COVID-19 RNA vaccine BNT162b1 in adults.,"In March 2020, the World Health Organization (WHO) declared coronavirus disease 2019 (COVID-19), which is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) 1 , a pandemic. With rapidly accumulating numbers of cases and deaths reported globally 2 , a vaccine is urgently needed. Here we report the available safety, tolerability and immunogenicity data from an ongoing placebo-controlled, observer-blinded dose-escalation study (ClinicalTrials.gov identifier NCT04368728) among 45 healthy adults (18-55 years of age), who were randomized to receive 2 doses-separated by 21 days-of 10 μg, 30 μg or 100 μg of BNT162b1. BNT162b1 is a lipid-nanoparticle-formulated, nucleoside-modified mRNA vaccine that encodes the trimerized receptor-binding domain (RBD) of the spike glycoprotein of SARS-CoV-2. Local reactions and systemic events were dose-dependent, generally mild to moderate, and transient. A second vaccination with 100 μg was not administered because of the increased reactogenicity and a lack of meaningfully increased immunogenicity after a single dose compared with the 30-μg dose. RBD-binding IgG concentrations and SARS-CoV-2 neutralizing titres in sera increased with dose level and after a second dose. Geometric mean neutralizing titres reached 1.9-4.6-fold that of a panel of COVID-19 convalescent human sera, which were obtained at least 14 days after a positive SARS-CoV-2 PCR. These results support further evaluation of this mRNA vaccine candidate.",2020,RBD-binding IgG concentrations and SARS-CoV-2,"['45 healthy adults, 18 to 55 years of age', 'adults']","['COVID-19 RNA vaccine BNT162b1', 'lipid nanoparticle-formulated, nucleoside-modified mRNA vaccine that encodes trimerized SARS-CoV-2 spike glycoprotein receptor-binding domain (RBD']","['Geometric mean neutralizing titers', 'Local reactions and systemic events', 'RBD-binding IgG concentrations and SARS-CoV-2', 'reactogenicity', 'neutralizing titers']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C1450054', 'cui_str': 'Nanoparticles'}, {'cui': 'C0028621', 'cui_str': 'Nucleoside'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0017968', 'cui_str': 'Glycoprotein'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0332297', 'cui_str': 'Bounded by'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0853813', 'cui_str': 'Local reaction'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0332297', 'cui_str': 'Bounded by'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]",45.0,0.183612,RBD-binding IgG concentrations and SARS-CoV-2,"[{'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Mulligan', 'Affiliation': 'New York University Langone Vaccine Center, New York, NY, USA.'}, {'ForeName': 'Kirsten E', 'Initials': 'KE', 'LastName': 'Lyke', 'Affiliation': 'University of Maryland School of Medicine, Center for Vaccine Development and Global Health, Baltimore, MD, USA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Kitchin', 'Affiliation': 'Vaccine Research and Development, Pfizer Inc, Hurley, UK.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Absalon', 'Affiliation': 'Vaccine Research and Development, Pfizer Inc, Pearl River, NY, USA. judith.absalon@pfizer.com.'}, {'ForeName': 'Alejandra', 'Initials': 'A', 'LastName': 'Gurtman', 'Affiliation': 'Vaccine Research and Development, Pfizer Inc, Pearl River, NY, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Lockhart', 'Affiliation': 'Vaccine Research and Development, Pfizer Inc, Hurley, UK.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Neuzil', 'Affiliation': 'University of Maryland School of Medicine, Center for Vaccine Development and Global Health, Baltimore, MD, USA.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Raabe', 'Affiliation': 'New York University Langone Vaccine Center, New York, NY, USA.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Bailey', 'Affiliation': 'Vaccine Research and Development, Pfizer Inc, Hurley, UK.'}, {'ForeName': 'Kena A', 'Initials': 'KA', 'LastName': 'Swanson', 'Affiliation': 'Vaccine Research and Development, Pfizer Inc, Pearl River, NY, USA.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': 'Vaccine Research and Development, Pfizer Inc, Collegeville, PA, USA.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Koury', 'Affiliation': 'Vaccine Research and Development, Pfizer Inc, Pearl River, NY, USA.'}, {'ForeName': 'Warren', 'Initials': 'W', 'LastName': 'Kalina', 'Affiliation': 'Vaccine Research and Development, Pfizer Inc, Pearl River, NY, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cooper', 'Affiliation': 'Vaccine Research and Development, Pfizer Inc, Pearl River, NY, USA.'}, {'ForeName': 'Camila', 'Initials': 'C', 'LastName': 'Fontes-Garfias', 'Affiliation': 'University of Texas Medical Branch, Galveston, TX, USA.'}, {'ForeName': 'Pei-Yong', 'Initials': 'PY', 'LastName': 'Shi', 'Affiliation': 'University of Texas Medical Branch, Galveston, TX, USA.'}, {'ForeName': 'Özlem', 'Initials': 'Ö', 'LastName': 'Türeci', 'Affiliation': 'BioNTech, Mainz, Germany.'}, {'ForeName': 'Kristin R', 'Initials': 'KR', 'LastName': 'Tompkins', 'Affiliation': 'Vaccine Research and Development, Pfizer Inc, Pearl River, NY, USA.'}, {'ForeName': 'Edward E', 'Initials': 'EE', 'LastName': 'Walsh', 'Affiliation': 'University of Rochester, Rochester, NY, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Frenck', 'Affiliation': ""Cincinnati Children's Hospital, Cincinnati, OH, USA.""}, {'ForeName': 'Ann R', 'Initials': 'AR', 'LastName': 'Falsey', 'Affiliation': 'University of Rochester, Rochester, NY, USA.'}, {'ForeName': 'Philip R', 'Initials': 'PR', 'LastName': 'Dormitzer', 'Affiliation': 'Vaccine Research and Development, Pfizer Inc, Pearl River, NY, USA.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Gruber', 'Affiliation': 'Vaccine Research and Development, Pfizer Inc, Pearl River, NY, USA.'}, {'ForeName': 'Uğur', 'Initials': 'U', 'LastName': 'Şahin', 'Affiliation': 'BioNTech, Mainz, Germany.'}, {'ForeName': 'Kathrin U', 'Initials': 'KU', 'LastName': 'Jansen', 'Affiliation': 'Vaccine Research and Development, Pfizer Inc, Pearl River, NY, USA.'}]",Nature,['10.1038/s41586-020-2639-4']
2421,32791501,Sequential Combination of Cognitive-Behavioral Treatment and Well-Being Therapy in Depressed Patients with Acute Coronary Syndromes: A Randomized Controlled Trial (TREATED-ACS Study).,"INTRODUCTION


Randomized controlled trials (RCT) of psychotherapeutic interventions have addressed depression and demoralization associated with acute coronary syndromes (ACS). The present trial introduces psychological well-being, an increasingly recognized factor in cardiovascular health, as a therapeutic target.
OBJECTIVE


This study was designed to determine whether the sequential combination of cognitive-behavioral therapy (CBT) and well-being therapy (WBT) may yield more favorable outcomes than an active control group (clinical management; CM) and to identify subgroups of patients at greater risk for cardiac negative outcomes.
METHODS


This multicenter RCT comparedCBT/WBT sequential combination versus CM, with up to 30 months of follow-up. One hundred consecutive depressed and/or demoralized patients (out of 740 initially screened by cardiologists after a first episode of ACS) were randomized to CBT/WBT associated with lifestyle suggestions (n = 50) and CM (n = 50). The main outcome measures included: severity of depressive symptoms according to the Clinical Interview for Depression, changes in subclinical psychological distress, well-being, and biomarkers, and medical complications and events.
RESULTS


CBT/WBT sequential combination was associated with a significant improvement in depressive symptoms compared to CM. In both groups, the benefits persisted at follow-up, even though the differences faded. Treatment was also related to a significant amelioration of biomarkers (platelet count, HDL, and D-dimer), whereas the 2 groups showed similar frequencies of adverse cardiac events.
CONCLUSIONS


Addressing psychological well-being in the psychotherapeutic approach to ACS patients with depressive symptoms was found to entail important clinical benefits. It is argued that lifestyle changes geared toward cardiovascular health may be facilitated by a personalized approach that targets well-being.",2020,"Treatment was also related to a significant amelioration of biomarkers (platelet count, HDL, and D-dimer), whereas the 2 groups showed similar frequencies of adverse cardiac events.
","['Depressed Patients with Acute Coronary Syndromes', 'One hundred consecutive depressed and/or demoralized patients (out of 740 initially screened by cardiologists after a first episode of ACS', 'ACS patients with depressive symptoms']","['cognitive-behavioral therapy (CBT) and well-being therapy (WBT', 'CBT/WBT', 'psychotherapeutic interventions', 'Sequential Combination of Cognitive-Behavioral Treatment and Well-Being Therapy']","['amelioration of biomarkers (platelet count, HDL, and D-dimer', 'severity of depressive symptoms according to the Clinical Interview for Depression, changes in subclinical psychological distress, well-being, and biomarkers, and medical complications and events', 'depressive symptoms']","[{'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0175906', 'cui_str': 'Cardiologist'}, {'cui': 'C0439615', 'cui_str': 'First episode'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0033978', 'cui_str': 'Psychotherapeutic agent'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0060323', 'cui_str': 'D-dimer'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0199182', 'cui_str': 'History taking'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205211', 'cui_str': 'Subclinical'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",100.0,0.0324152,"Treatment was also related to a significant amelioration of biomarkers (platelet count, HDL, and D-dimer), whereas the 2 groups showed similar frequencies of adverse cardiac events.
","[{'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Rafanelli', 'Affiliation': 'Department of Psychology, University of Bologna, Bologna, Italy, chiara.rafanelli@unibo.it.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Gostoli', 'Affiliation': 'Department of Psychology, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Buzzichelli', 'Affiliation': 'Eating Disorders Center for Treatment and Research, Department of Neuroscience, University of Turin, Turin, Italy.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Guidi', 'Affiliation': 'Department of Psychology, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Sirri', 'Affiliation': 'Department of Psychology, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Gallo', 'Affiliation': 'Division of Cardiology, Maggiore Hospital, Bologna, Italy.'}, {'ForeName': 'Enrica', 'Initials': 'E', 'LastName': 'Marzola', 'Affiliation': 'Eating Disorders Center for Treatment and Research, Department of Neuroscience, University of Turin, Turin, Italy.'}, {'ForeName': 'Serena', 'Initials': 'S', 'LastName': 'Bergerone', 'Affiliation': 'Division of Cardiology, Internal Medicine Department, Città della Salute e della Scienza, University of Turin, Turin, Italy.'}, {'ForeName': 'Gaetano Maria', 'Initials': 'GM', 'LastName': 'De Ferrari', 'Affiliation': 'Division of Cardiology, Internal Medicine Department, Città della Salute e della Scienza, University of Turin, Turin, Italy.'}, {'ForeName': 'Renzo', 'Initials': 'R', 'LastName': 'Roncuzzi', 'Affiliation': 'Division of Cardiology, Bellaria Hospital, Bologna, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Di Pasquale', 'Affiliation': 'Division of Cardiology, Maggiore Hospital, Bologna, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Abbate-Daga', 'Affiliation': 'Eating Disorders Center for Treatment and Research, Department of Neuroscience, University of Turin, Turin, Italy.'}, {'ForeName': 'Giovanni A', 'Initials': 'GA', 'LastName': 'Fava', 'Affiliation': 'Department of Psychiatry, University at Buffalo, Buffalo, New York, USA.'}]",Psychotherapy and psychosomatics,['10.1159/000510006']
2422,32771013,Erythropoietin prevents necrotizing enterocolitis in very preterm infants: a randomized controlled trial.,"BACKGROUND


Necrotizing enterocolitis (NEC) is one of the most severe complications in very preterm infants, but there are currently no accepted methods to prevent NEC. Studies have shown that erythropoietin (EPO) has the potential to prevent NEC or improve outcomes of preterm NEC. This study aimed to determine whether recombinant human EPO (rhEPO) could protect against NEC in very preterm infants.
METHODS


The study was a prospective randomized clinical trial performed among four NICU centers. A total of 1327 preterm infants with gestational age ≤ 32 weeks were admitted to the centers, and 42 infants were excluded leaving 1285 eligible infants to be randomized to the rhEPO or control group. Infants in the rhEPO group were given 500 IU/kg rhEPO intravenously every other day for 2 weeks, while the control group was given the same volume of saline. The primary outcome was the incidence of NEC in very preterm infants at 36 weeks of corrected gestational age.
RESULTS


A total of 1285 infants were analyzed at 36 weeks of corrected age for the incidence of NEC. rhEPO treatment significantly decreased the incidence of NEC (stage I, II and III) (12.0% vs. 17.1%, p = 0.010), especially confirmed NEC (stage II and III) (3.0% vs. 5.4%, p = 0.027). Meanwhile, rhEPO treatment significantly reduced the number of red blood cells transfusion in the confirmed NEC cases (1.2 ± 0.4 vs. 2.7 ± 1.0, p = 0.004). Subgroup analyses showed that rhEPO treatment significantly decreased the incidence of confirmed NEC at gestational age < 28 weeks (p = 0.019), and the incidence of all stages NEC in preterm infants with hemoglobin < 90 g/l (p = 0.000) and 5 min Apgar score > 5 (p = 0.028).
CONCLUSION


Repeated low-dose rhEPO treatment is beneficial against NEC in very preterm infants. Trial registration The protocol was registered retrospectively at ClinicalTrials.gov (NCT03919500) on April 18, 2019. https://clinicaltrials.gov/ct2/show/NCT03919500.",2020,"/l (p = 0.000) and 5 min Apgar score > 5 (p = 0.028).
","['very preterm infants', 'preterm infants with hemoglobin <\u200990\xa0g', '1327 preterm infants with gestational age ≤\u200932\xa0weeks were admitted to the centers, and 42 infants were excluded leaving 1285 eligible infants', 'A total of 1285 infants were analyzed at 36\xa0weeks of corrected age for the incidence of NEC']","['Erythropoietin', 'recombinant human EPO (rhEPO', 'rhEPO', 'rhEPO or control group', 'erythropoietin (EPO']","['incidence of confirmed NEC', 'incidence of NEC (stage I, II and III', 'necrotizing enterocolitis', 'number of red blood cells transfusion', 'incidence of NEC']","[{'cui': 'C3897192', 'cui_str': 'Very preterm infant'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0439087', 'cui_str': '<90'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0014356', 'cui_str': 'Enterocolitis'}]","[{'cui': 'C0014822', 'cui_str': 'erythropoietin'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0014356', 'cui_str': 'Enterocolitis'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0086252', 'cui_str': 'Transfusion of red blood cells'}]",1327.0,0.179091,"/l (p = 0.000) and 5 min Apgar score > 5 (p = 0.028).
","[{'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Henan Key Laboratory of Child Brain Injury, Department of Neonatology, Institute of Neuroscience and Third Affiliated Hospital of Zhengzhou University, Zhengzhou, 450052, China.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Song', 'Affiliation': 'Henan Key Laboratory of Child Brain Injury, Department of Neonatology, Institute of Neuroscience and Third Affiliated Hospital of Zhengzhou University, Zhengzhou, 450052, China.'}, {'ForeName': 'Huiqing', 'Initials': 'H', 'LastName': 'Sun', 'Affiliation': ""Department of Neonatology, Children's Hospital of Zhengzhou University, Zhengzhou, 450018, China.""}, {'ForeName': 'Falin', 'Initials': 'F', 'LastName': 'Xu', 'Affiliation': 'Henan Key Laboratory of Child Brain Injury, Department of Neonatology, Institute of Neuroscience and Third Affiliated Hospital of Zhengzhou University, Zhengzhou, 450052, China.'}, {'ForeName': 'Kenan', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': 'Henan Key Laboratory of Child Brain Injury, Department of Neonatology, Institute of Neuroscience and Third Affiliated Hospital of Zhengzhou University, Zhengzhou, 450052, China.'}, {'ForeName': 'Chunxia', 'Initials': 'C', 'LastName': 'Nie', 'Affiliation': 'Department of Neonatology, Women and Children Health Care Center of Luoyang, Luoyang, 471000, China.'}, {'ForeName': 'Xiaoli', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Henan Key Laboratory of Child Brain Injury, Department of Neonatology, Institute of Neuroscience and Third Affiliated Hospital of Zhengzhou University, Zhengzhou, 450052, China.'}, {'ForeName': 'Xirui', 'Initials': 'X', 'LastName': 'Peng', 'Affiliation': 'Henan Key Laboratory of Child Brain Injury, Department of Neonatology, Institute of Neuroscience and Third Affiliated Hospital of Zhengzhou University, Zhengzhou, 450052, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Xia', 'Affiliation': 'Henan Key Laboratory of Child Brain Injury, Department of Neonatology, Institute of Neuroscience and Third Affiliated Hospital of Zhengzhou University, Zhengzhou, 450052, China.'}, {'ForeName': 'Ziyun', 'Initials': 'Z', 'LastName': 'Shen', 'Affiliation': 'Department of Neonatology, First Affiliated Hospital of Zhengzhou University, Zhengzhou, 450052, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Yuan', 'Affiliation': 'Henan Key Laboratory of Child Brain Injury, Department of Neonatology, Institute of Neuroscience and Third Affiliated Hospital of Zhengzhou University, Zhengzhou, 450052, China.'}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Henan Key Laboratory of Child Brain Injury, Department of Neonatology, Institute of Neuroscience and Third Affiliated Hospital of Zhengzhou University, Zhengzhou, 450052, China.'}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Ding', 'Affiliation': 'Henan Key Laboratory of Child Brain Injury, Department of Neonatology, Institute of Neuroscience and Third Affiliated Hospital of Zhengzhou University, Zhengzhou, 450052, China.'}, {'ForeName': 'Yaodong', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Department of Neonatology, Children's Hospital of Zhengzhou University, Zhengzhou, 450018, China.""}, {'ForeName': 'Wenqing', 'Initials': 'W', 'LastName': 'Kang', 'Affiliation': ""Department of Neonatology, Children's Hospital of Zhengzhou University, Zhengzhou, 450018, China.""}, {'ForeName': 'Liling', 'Initials': 'L', 'LastName': 'Qian', 'Affiliation': ""Department of Pediatrics, Children's Hospital of Fudan University, Shanghai, China.""}, {'ForeName': 'Wenhao', 'Initials': 'W', 'LastName': 'Zhou', 'Affiliation': ""Department of Pediatrics, Children's Hospital of Fudan University, Shanghai, China.""}, {'ForeName': 'Xiaoyang', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Henan Key Laboratory of Child Brain Injury, Department of Neonatology, Institute of Neuroscience and Third Affiliated Hospital of Zhengzhou University, Zhengzhou, 450052, China.'}, {'ForeName': 'Xiuyong', 'Initials': 'X', 'LastName': 'Cheng', 'Affiliation': 'Department of Neonatology, First Affiliated Hospital of Zhengzhou University, Zhengzhou, 450052, China.'}, {'ForeName': 'Changlian', 'Initials': 'C', 'LastName': 'Zhu', 'Affiliation': 'Henan Key Laboratory of Child Brain Injury, Department of Neonatology, Institute of Neuroscience and Third Affiliated Hospital of Zhengzhou University, Zhengzhou, 450052, China. changlian.zhu@neuro.gu.se.'}]",Journal of translational medicine,['10.1186/s12967-020-02459-w']
2423,32777383,"Rationale, design, and methods of the Autism Centers of Excellence (ACE) network Study of Oxytocin in Autism to improve Reciprocal Social Behaviors (SOARS-B).","OBJECTIVE


To describe the rationale, design, and methods of the Autism Centers of Excellence (ACE) network Study of Oxytocin in Autism to improve Reciprocal Social Behaviors (SOARS-B).
METHOD


This phase 2 clinical trial was designed to evaluate the use of intranasal oxytocin treatment to improve social difficulties in individuals with autism spectrum disorder (ASD). In total, 290 participants ages 3 to 17 years with a DSM-5 diagnosis of ASD were enrolled to receive 24 weeks of treatment with either oxytocin or a matched placebo at one of seven collaborating sites. Participants were subsequently treated with open-label oxytocin for 24 additional weeks. Post-treatment assessments were done approximately 4 weeks after treatment discontinuation. Plasma oxytocin and oxytocin receptor gene (OXTR) methylation level were measured at baseline, and week 8, 24 and 36 to explore potential relationships between these biomarkers and treatment response.
RESULTS


This report describes the rationale, design, and methods of the SOARS-B clinical trial.
CONCLUSIONS


There is a tremendous unmet need for safe and effective pharmacological treatment options that target the core symptoms of ASD. Several studies support the hypothesis that intranasal oxytocin could improve social orienting and the salience of social rewards in ASD, thereby enhancing reciprocal social behaviors. However, due to conflicting results from a number of pilot studies on the prosocial effects of exogenous oxytocin, this hypothesis remains controversial and inconclusive. SOARS-B is the best powered study to date to address this hypothesis and promises to improve our understanding of the safety and efficacy of intranasal oxytocin in the treatment of social deficits in children with ASD.",2020,"Plasma oxytocin and oxytocin receptor gene (OXTR) methylation level were measured at baseline, week 8, 24 and 36 to explore potential relationships between these biomarkers and treatment response.
","['individuals with autism spectrum disorder (ASD', 'children with ASD', '290 participants ages 3 to 17\u202fyears with a DSM-5 diagnosis of ASD']","['oxytocin', 'intranasal oxytocin', 'Oxytocin', 'open-label oxytocin', 'oxytocin or a matched placebo']","['Plasma oxytocin and oxytocin receptor gene (OXTR) methylation level', 'Reciprocal Social Behaviors (SOARS-B', 'reciprocal social behaviors (SOARS-B', 'social orienting', 'social difficulties']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C5191218', 'cui_str': '290'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0069841', 'cui_str': 'Oxytocin Receptor'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0025723', 'cui_str': 'Methylation'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0037397', 'cui_str': 'Social behavior'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}]",290.0,0.0611497,"Plasma oxytocin and oxytocin receptor gene (OXTR) methylation level were measured at baseline, week 8, 24 and 36 to explore potential relationships between these biomarkers and treatment response.
","[{'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Spanos', 'Affiliation': 'Duke Center for Autism and Brain Development, Department of Psychiatry and Behavioral Sciences, Duke University, Durham, NC, United States of America. Electronic address: marina.spanos@duke.edu.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Chandrasekhar', 'Affiliation': 'Duke Center for Autism and Brain Development, Department of Psychiatry and Behavioral Sciences, Duke University, Durham, NC, United States of America.'}, {'ForeName': 'Soo-Jeong', 'Initials': 'SJ', 'LastName': 'Kim', 'Affiliation': ""Seattle Children's Autism Center, Department of Psychiatry and Behavioral Sciences, University of Washington; Seattle, WA, United States of America.""}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Hamer', 'Affiliation': 'Departments of Psychiatry and Biostatistics, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States of America.'}, {'ForeName': 'Bryan H', 'Initials': 'BH', 'LastName': 'King', 'Affiliation': ""Department of Psychiatry and Weill Institute for Neurosciences, University of California San Francisco, UCSF Benioff Children's Hospitals, San Francisco, CA, United States of America.""}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'McDougle', 'Affiliation': 'Lurie Center for Autism, Massachusetts General Hospital; Department of Psychiatry, Harvard Medical School, Boston, MA, United States of America.'}, {'ForeName': 'Kevin B', 'Initials': 'KB', 'LastName': 'Sanders', 'Affiliation': 'Neuroscience Product Development, F. Hoffmann-La Roche, Basel, Switzerland.'}, {'ForeName': 'Simon G', 'Initials': 'SG', 'LastName': 'Gregory', 'Affiliation': 'Duke Molecular Physiology Institute, Duke University School of Medicine, Durham, NC, United States of America; Department of Neurology, Duke University School of Medicine, Durham, NC, United States of America.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Kolevzon', 'Affiliation': 'Seaver Autism Center for Research and Treatment, Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, United States of America.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Veenstra-VanderWeele', 'Affiliation': 'Department of Psychiatry, Columbia University; New York State Psychiatric Institute; Center for Autism and the Developing Brain, New York-Presbyterian Hospital, United States of America.'}, {'ForeName': 'Linmarie', 'Initials': 'L', 'LastName': 'Sikich', 'Affiliation': 'Duke Center for Autism and Brain Development, Department of Psychiatry and Behavioral Sciences, Duke University, Durham, NC, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106103']
2424,32783084,[Alleviating radiation-induced xerostomia with chewing gum: a randomized phase III trial].,,2020,,[],['Alleviating radiation-induced xerostomia with chewing gum'],[],[],"[{'cui': 'C1275047', 'cui_str': 'Radiation-induced xerostomia'}, {'cui': 'C0008037', 'cui_str': 'Chewing Gum'}]",[],,0.016268,,"[{'ForeName': 'Robert Michael', 'Initials': 'RM', 'LastName': 'Hermann', 'Affiliation': 'Zentrum für Strahlentherapie und Radioonkologie, Mozartstr.\xa030, 26655, Westerstede, Deutschland. hermann@strahlentherapie-westerstede.com.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Christiansen', 'Affiliation': 'Klinik für Strahlentherapie und Spezielle Onkologie, Medizinische Hochschule Hannover, Hannover, Deutschland.'}]",Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al],['10.1007/s00066-020-01673-1']
2425,32783178,Treatment effect of palbociclib plus endocrine therapy by prognostic and intrinsic subtype and biomarker analysis in patients with bone-only disease: a joint analysis of PALOMA-2 and PALOMA-3 clinical trials.,"PURPOSE


This analysis evaluated the relationship between treatment-free interval (TFI, in PALOMA-2)/disease-free interval (DFI, in PALOMA-3) and progression-free survival (PFS) and overall survival (OS, in PALOMA-3), treatment effect in patients with bone-only disease, and whether intrinsic subtype affects PFS in patients receiving palbociclib.
METHODS


Data were from phase 3, randomized PALOMA-2 and PALOMA-3 clinical studies of hormone receptor‒positive/human epidermal growth factor receptor 2‒negative (HR+ /HER2-) advanced breast cancer (ABC) patients receiving endocrine therapy plus palbociclib or placebo. Subpopulation treatment effect pattern plot (STEPP) analysis evaluated the association between DFI and PFS and OS. PFS by luminal subtype and cyclin-dependent kinase (CDK) 4/6 or endocrine pathway gene expression levels were evaluated in patients with bone-only disease; median PFS and OS were estimated by the Kaplan-Meier method.
RESULTS


Median durations of TFI were 37.1 and 30.9 months (PALOMA-2) and DFI were 49.2 and 52.0 months (PALOMA-3) in the palbociclib and placebo groups, respectively. Among the PALOMA-2 biomarker population (n = 454), 23% had bone-only disease; median PFS was longer with palbociclib versus placebo (31.3 vs 11.2 months; hazard ratio, 0.41; 95% CI 0.25‒0.69). The interaction effect of bone-only versus visceral disease subgroups on median PFS with palbociclib was not significant (P = 0.262). Among the PALOMA-3 biomarker population (n = 302), 27% had bone-only disease. STEPP analyses showed that palbociclib PFS benefit was not affected by DFI, and that palbociclib OS effect may be smaller in patients with short DFIs. Among patients who provided metastatic tumor tissues (n = 142), regardless of luminal A (hazard ratio, 0.23; 95% CI 0.11‒0.47; P = 0.0000158) or luminal B (hazard ratio, 0.26; 95% CI 0.12‒0.56; P = 0.000269) subtype, palbociclib improved PFS versus placebo.
CONCLUSIONS


These findings support palbociclib plus endocrine therapy as standard of care for HR+ /HER2- ABC patients, regardless of baseline TFI/DFI or intrinsic molecular subtype, including patients with bone-only disease.
TRIAL REGISTRATION


Pfizer (clinicaltrials.gov:NCT01740427, NCT01942135).",2020,The interaction effect of bone-only versus visceral disease subgroups on median PFS with palbociclib was not significant (P = 0.262).,"['advanced breast cancer (ABC) patients receiving', 'patients with short DFIs', 'patients with bone-only disease']","['palbociclib plus endocrine therapy', 'endocrine therapy plus palbociclib or placebo', 'plot (STEPP', 'hormone receptor‒positive/human epidermal growth factor receptor 2‒negative (HR+\u2009/HER2', 'placebo']","['bone-only disease; median PFS', 'DFI and PFS and OS', '4/6 or endocrine pathway gene expression levels', 'bone-only disease', 'median PFS with palbociclib', 'PFS by luminal subtype and cyclin-dependent kinase (CDK', 'treatment-free interval (TFI, in PALOMA-2)/disease-free interval (DFI, in PALOMA-3) and progression-free survival (PFS) and overall survival', 'Median durations of TFI', 'palbociclib PFS benefit']","[{'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C3853822', 'cui_str': 'palbociclib'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1257890', 'cui_str': 'Group'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C1509244', 'cui_str': 'human epidermal growth factor'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}]","[{'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0014136', 'cui_str': 'Structure of endocrine system'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C3853822', 'cui_str': 'palbociclib'}, {'cui': 'C0699493', 'cui_str': 'Luminal'}, {'cui': 'C0449560', 'cui_str': 'Subtype'}, {'cui': 'C0243045', 'cui_str': 'cdk Proteins'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]",,0.323609,The interaction effect of bone-only versus visceral disease subgroups on median PFS with palbociclib was not significant (P = 0.262).,"[{'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Finn', 'Affiliation': 'Division of Hematology/Oncology, David Geffen School of Medicine at UCLA, 2825 Santa Monica Blvd, Suite 200, Santa Monica, CA, USA. RFinn@mednet.ucla.edu.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Cristofanilli', 'Affiliation': 'Robert H. Lurie Comprehensive Cancer Center, Feinberg School of Medicine, 710 N Fairbanks Ct, Suite 8-250A, Chicago, IL, USA.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Ettl', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medicine, Klinikum Rechts der Isar, Technical University of Munich, Ismaninger Str 22, 81675, Munich, Germany.'}, {'ForeName': 'Karen A', 'Initials': 'KA', 'LastName': 'Gelmon', 'Affiliation': 'British Columbia Cancer Agency, 675 West 10th Ave, Vancouver, BC, Canada.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Colleoni', 'Affiliation': 'IEO European Institute of Oncology, IRCCS, Via Ripamonti 435, Milan, Italy.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Giorgetti', 'Affiliation': 'Pfizer Italia, Via Anna Maria Mozzoni, 12, Milan, Italy.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Gauthier', 'Affiliation': 'Pfizer Inc, 525 Market Street, San Francisco, CA, USA.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Pfizer Inc, 10646 Science Center Dr, La Jolla, San Diego, CA, USA.'}, {'ForeName': 'Dongrui R', 'Initials': 'DR', 'LastName': 'Lu', 'Affiliation': 'Pfizer Inc, 10646 Science Center Dr, La Jolla, San Diego, CA, USA.'}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Pfizer Inc, 10646 Science Center Dr, La Jolla, San Diego, CA, USA.'}, {'ForeName': 'Cynthia Huang', 'Initials': 'CH', 'LastName': 'Bartlett', 'Affiliation': 'Pfizer Inc, 500 Arcola Rd, Collegeville, PA, USA.'}, {'ForeName': 'Dennis J', 'Initials': 'DJ', 'LastName': 'Slamon', 'Affiliation': 'Division of Hematology/Oncology, David Geffen School of Medicine at UCLA, 2825 Santa Monica Blvd, Suite 200, Santa Monica, CA, USA.'}, {'ForeName': 'Nicholas C', 'Initials': 'NC', 'LastName': 'Turner', 'Affiliation': 'Royal Marsden Hospital and Institute of Cancer Research, Fulham Rd, London, SW3 6JJ, UK.'}, {'ForeName': 'Hope S', 'Initials': 'HS', 'LastName': 'Rugo', 'Affiliation': 'University of California San Francisco Comprehensive Center, 1600 Divisadero St, San Francisco, CA, USA.'}]",Breast cancer research and treatment,['10.1007/s10549-020-05782-4']
2426,32787352,Evaluation of the effects of applying the ventricular care bundle (VCB) method for reducing ventilator-associated pneumonia (VAP) in the intensive care unit of a general Chinese tertiary hospital.,"BACKGROUND


Ventilator-associated pneumonia (VAP) is a severe complication that occurs within patients who must use ventilators in the intensive care unit (ICU). Ventilator care bundles (VCB) have been applied across many developed regions and have produced positive results in controlling VAP. In this study, we report on the implementation and effects of using VCBs to manage VAP in a general tertiary hospital in the Inner Mongolia Autonomous Region of China.
METHODS


A targeted surveillance method was used to survey all the patients (n=4,716) in the ICU from June 1, 2017 to May 31, 2019. Patients from June 1, 2017 to May 31, 2018, and June 1, 2018, to May 31, 2019, were respectively divided into 2 groups: the control group (2,029 patients) and intervention group (2,687 patients). These dates were selected because VCB was implemented from June 1, 2018, in our institution. The variables that were associated with VCB and observed were the head-of-bed elevation, oral care, maintenance of the pressure for the cuff of the endotracheal tube, aspiration of subglottic secretion, daily sedation vacation protocol, daily extubation assessment results, and hand hygiene. After collecting the data, the compliance of VCB, ventilator use ratio, and the incidence rate of VAP in these 2 groups were compared.
RESULTS


We observed that compliance with all of the intervention measures for VCB improved results in the intervention group compared to the control. Furthermore, the compliance rate of hand hygiene increased from 71.99% to 91.97%, and the head-of-bed elevation of 30°-45° increased from 62.02% to 85.96%. All differences between these two groups were statistically significant, according to the χ 2 -test. The ventilator use ratio was statistically and significantly lower in the intervention group (34.86%) compared to the control group (40.29%) (χ 2 =95.513, P<0.001). The incidence rate of VAP was statistically and significantly lower in the intervention group (13.70‰) compared to the control group (18.85‰) (χ 2 =5.471, P=0.019).
CONCLUSIONS


Our results show that VCB prevents VAP. Therefore, personnel training, clinical supervision, and surveillance feedback could promote a reduction in intervention measures.",2020,The ventilator use ratio was statistically and significantly lower in the intervention group (34.86%) compared to the control group (40.29%),"['ventilator-associated pneumonia (VAP) in the intensive care unit of a general Chinese tertiary hospital', 'Patients from June 1, 2017 to May 31, 2018, and June 1, 2018, to May 31, 2019, were respectively divided into 2 groups: the control group (2,029 patients) and intervention group (2,687 patients', 'patients (n=4,716) in the ICU from June 1, 2017 to May 31, 2019', 'general tertiary hospital in the Inner Mongolia Autonomous Region of China', 'patients who must use ventilators in the intensive care unit (ICU']","['VCBs', 'VCB', 'ventricular care bundle (VCB) method', 'Ventilator care bundles (VCB']","['compliance rate of hand hygiene', 'head-of-bed elevation, oral care, maintenance of the pressure for the cuff of the endotracheal tube, aspiration of subglottic secretion, daily sedation vacation protocol, daily extubation assessment results, and hand hygiene', 'incidence rate of VAP', 'ventilator use ratio', 'compliance of VCB, ventilator use ratio, and the incidence rate of VAP']","[{'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0021515', 'cui_str': 'Inner Mongolia'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]","[{'cui': 'C0184634', 'cui_str': 'Ventilator care'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C3658308', 'cui_str': 'Care Bundles'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C3494474', 'cui_str': 'Hand Hygiene'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0441107', 'cui_str': 'Device cuff'}, {'cui': 'C0336630', 'cui_str': 'Endotracheal tube'}, {'cui': 'C0004056', 'cui_str': 'Aspiration, Psychology'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0184634', 'cui_str': 'Ventilator care'}]",,0.0316688,The ventilator use ratio was statistically and significantly lower in the intervention group (34.86%) compared to the control group (40.29%),"[{'ForeName': 'Weiping', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': ""Department of Nosocomial Infection control, Inner Mongolia People's Hospital, Hohhot, China.""}, {'ForeName': 'Yongfang', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': ""Department of Nosocomial Infection control, Inner Mongolia People's Hospital, Hohhot, China.""}, {'ForeName': 'Yueying', 'Initials': 'Y', 'LastName': 'Jiao', 'Affiliation': ""Department of Nosocomial Infection control, Inner Mongolia People's Hospital, Hohhot, China.""}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Zhang', 'Affiliation': ""Department of Nosocomial Infection control, Inner Mongolia People's Hospital, Hohhot, China.""}, {'ForeName': 'Yunting', 'Initials': 'Y', 'LastName': 'Hai', 'Affiliation': ""Department of Nosocomial Infection control, Inner Mongolia People's Hospital, Hohhot, China.""}, {'ForeName': 'Haoxue', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': ""Department of Nosocomial Infection control, Inner Mongolia People's Hospital, Hohhot, China.""}, {'ForeName': 'Huimin', 'Initials': 'H', 'LastName': 'Xing', 'Affiliation': ""Department of Nosocomial Infection control, Inner Mongolia People's Hospital, Hohhot, China.""}, {'ForeName': 'Binbin', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': ""Department of Nosocomial Infection control, Inner Mongolia People's Hospital, Hohhot, China.""}, {'ForeName': 'Haibo', 'Initials': 'H', 'LastName': 'Bai', 'Affiliation': ""Department of Nosocomial Infection control, Inner Mongolia People's Hospital, Hohhot, China.""}, {'ForeName': 'Yuping', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': ""Department of Nosocomial Infection control, Inner Mongolia People's Hospital, Hohhot, China.""}, {'ForeName': 'Huan', 'Initials': 'H', 'LastName': 'Bao', 'Affiliation': ""Department of Nosocomial Infection control, Inner Mongolia People's Hospital, Hohhot, China.""}, {'ForeName': 'Shuai', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': ""Department of Nosocomial Infection control, Inner Mongolia People's Hospital, Hohhot, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Ren', 'Affiliation': ""Department of Nosocomial Infection control, Inner Mongolia People's Hospital, Hohhot, China.""}, {'ForeName': 'Lifang', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': ""Department of Nosocomial Infection control, Inner Mongolia People's Hospital, Hohhot, China.""}, {'ForeName': 'Huijun', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': ""Department of Nosocomial Infection control, Inner Mongolia People's Hospital, Hohhot, China.""}, {'ForeName': 'Junwei', 'Initials': 'J', 'LastName': 'Tian', 'Affiliation': ""Department of Nosocomial Infection control, Inner Mongolia People's Hospital, Hohhot, China.""}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': ""Department of Nosocomial Infection control, Inner Mongolia People's Hospital, Hohhot, China.""}, {'ForeName': 'Tianhui', 'Initials': 'T', 'LastName': 'Guo', 'Affiliation': ""Department of Nosocomial Infection control, Inner Mongolia People's Hospital, Hohhot, China. tianhui0409@126.com.""}]",Annals of palliative medicine,['10.21037/apm-20-289']
2427,32787361,Effects of the prolong life with nine turn method (Yan Nian Jiu Zhuan) Qigong on patients with chronic fatigue syndrome: study protocol for a randomized controlled trial.,"BACKGROUND


Chronic fatigue syndrome (CFS) is characterized by persistent fatigue, which often leads to physical and psychological damage. Cognitive behavioral therapy (CBT) is considered to be one of the most effective treatments. Prolong life with nine turn method (PLWNT) Qigong is a combination of complex two-way traffic path connecting the cognitive center and the enteric nerves. In this study protocol, we will explore the effectiveness of PLWNT for physical and mental fatigue, gastrointestinal function, depression, and sleep quality in patients with CFS using clinical effectiveness scales and functional magnetic imaging (fMRI).
METHODS


A randomized controlled trial (RCT) consisting of 90 patients will be divided into a CBT and PLWNT group. Both of the groups will include a supervised intervention at the Shanghai University of Traditional Chinese Medicine once a week, and the remaining six days will be completed at home over 12 consecutive weeks. The primary outcome variable will be the Multidimensional Fatigue Inventory (MFI20). Secondary outcomes will evaluate the Short Form 36-item Health Survey (SF-36), the Pittsburgh Sleep Quality Index (PSQI), the Hospital Anxiety and Depression Scale (HADS), and brain activation will be explored using fMRI.
RESULTS


This will be the first randomized controlled clinical trial to introduce the PLWNT method for the treatment of CFS. If these results demonstrate that CBT or PLWNT interventions are effective, they will provide a quality treatment plan for patients with chronic fatigue and optimize their guidance.
TRIAL REGISTRATION


Clinical Trials Registry, NCT03496961, Registered on April 12, 2018.",2020,"Secondary outcomes will evaluate the Short Form 36-item Health Survey (SF-36), the Pittsburgh Sleep Quality Index (PSQI), the Hospital Anxiety and Depression Scale (HADS), and brain activation will be explored using fMRI.
","['patients with CFS', 'patients with chronic fatigue syndrome', '90 patients', 'patients with chronic fatigue and optimize their guidance', 'Chronic fatigue syndrome (CFS']","['Qigong', 'CBT or PLWNT interventions', 'CBT and PLWNT', 'nine turn method (Yan Nian Jiu Zhuan', 'functional magnetic imaging (fMRI', 'Cognitive behavioral therapy (CBT', 'nine turn method (PLWNT']","['physical and mental fatigue, gastrointestinal function, depression, and sleep quality', 'Multidimensional Fatigue Inventory (MFI20', 'Short Form 36-item Health Survey (SF-36), the Pittsburgh Sleep Quality Index (PSQI), the Hospital Anxiety and Depression Scale (HADS), and brain activation will be explored using fMRI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015674', 'cui_str': 'Chronic fatigue syndrome'}, {'cui': 'C0518656', 'cui_str': 'Chronic fatigue'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}]","[{'cui': 'C0282077', 'cui_str': 'Qigong'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0541749', 'cui_str': 'Does turn'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0044523', 'cui_str': '1-nitrosoindole-3-acetonitrile'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0024488', 'cui_str': 'Magnetics'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0015676', 'cui_str': 'Mental fatigue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}]",90.0,0.127951,"Secondary outcomes will evaluate the Short Form 36-item Health Survey (SF-36), the Pittsburgh Sleep Quality Index (PSQI), the Hospital Anxiety and Depression Scale (HADS), and brain activation will be explored using fMRI.
","[{'ForeName': 'Fangfang', 'Initials': 'F', 'LastName': 'Xie', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Chong', 'Initials': 'C', 'LastName': 'Guan', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Ziji', 'Initials': 'Z', 'LastName': 'Cheng', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Yao', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Shanghai University of Traditional Chinese Medicine, Shanghai, China. doctoryaofei@126.com.'}, {'ForeName': 'Yanli', 'Initials': 'Y', 'LastName': 'You', 'Affiliation': 'Department of Traditional Chinese Medicine, Changhai Hospital, Naval Medical University, Shanghai, China. youyanli2005@163.com.'}]",Annals of palliative medicine,['10.21037/apm-19-461']
2428,32791321,Guilt and expressive writing for reducing alcohol use in college students: Study protocol for a randomized control trial.,"The current proposed study aims to evaluate expressive writing as a novel intervention for reducing problematic drinking among college students. College students are at increased risk for alcohol misuse compared to other adults, and the development of efficacious intervention approaches is an urgent priority. The vast majority of individually focused brief interventions targeting college drinking have focused on personalized feedback approaches and recent innovations have largely been limited to refinements of this paradigm, which require large-scale assessment and intricate programming for implementation. The present research proposes expressive writing as a novel alternative, which has been used extensively in other domains but not as an alcohol intervention strategy. We propose a theoretically-based approach that incorporates expression of the self-conscious emotion of guilt and the written analogue of change talk as proposed mechanisms of intervention efficacy. We will also examine individual differences in guilt-proneness as a moderator of intervention efficacy. Heavy drinking college students (N = 600) will be randomly assigned to one of six expressive writing conditions based on a 2 (alcohol vs. distress) × 2 (guilt vs. no guilt) + 1 (control writing) + 1 (personalized feedback) design. Participation in the study involves completion of a screening assessment, a baseline assessment, three in-lab intervention sessions, post-intervention assessments, and follow-up assessments one-month, three-months, six months, and twelve-months later. If effective, this novel intervention approach would not require any pre-assessment or programming of personalized feedback, and would serve as a more easily disseminable alternative to existing approaches.",2020,"If effective, this novel intervention approach would not require any pre-assessment or programming of personalized feedback, and would serve as a more easily disseminable alternative to existing approaches.","['College students', 'Heavy drinking college students (N\u202f=\u202f600', 'college students']","['\u202f1 (control writing', 'Guilt and expressive writing', 'six expressive writing conditions based on a 2 (alcohol vs. distress']",[],"[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C3816748', 'cui_str': '600'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018582', 'cui_str': 'Handwriting'}, {'cui': 'C0018379', 'cui_str': 'Feeling guilt'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0231303', 'cui_str': 'Distress'}]",[],600.0,0.018722,"If effective, this novel intervention approach would not require any pre-assessment or programming of personalized feedback, and would serve as a more easily disseminable alternative to existing approaches.","[{'ForeName': 'Clayton', 'Initials': 'C', 'LastName': 'Neighbors', 'Affiliation': 'Department of Psychology, University of Houston, Houston, TX, United States of America.'}, {'ForeName': 'Jordanna Lembo', 'Initials': 'JL', 'LastName': 'Riggs', 'Affiliation': 'Department of Psychology, University of Houston, Houston, TX, United States of America.'}, {'ForeName': 'Chelsie M', 'Initials': 'CM', 'LastName': 'Young', 'Affiliation': 'Department of Psychology, Rowan University, Glassboro, NJ, United States of America.'}, {'ForeName': 'Lindsey M', 'Initials': 'LM', 'LastName': 'Rodriguez', 'Affiliation': 'Department of Psychology, University of South Florida St. Petersburg, St. Petersburg, FL, United States of America.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Angosta', 'Affiliation': 'Department of Psychology, University of Houston, Houston, TX, United States of America. Electronic address: jangosta@central.uh.edu.'}, {'ForeName': 'Pelin', 'Initials': 'P', 'LastName': 'Cunningham-Erdogdu', 'Affiliation': 'Department of Psychology, University of Houston, Houston, TX, United States of America; Department of Psychology, University of Texas at Austin, Austin, TX, United States of America.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Lu', 'Affiliation': 'Department of Health Disparities Research, University of Texas, MD Anderson Cancer Center, Houston, TX, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106107']
2429,32795144,Content Analysis: First-Time Patient User Challenges with Top-Rated Commercial Diabetes Apps.,"Background/Introduction:  Using a mobile application (app) may improve diabetes self-management. However, the use of diabetes apps is low, possibly due to design and usability issues. The purpose of this study was to identify barriers to app use among adult patients with diabetes who were testing diabetes apps for the first time.  Materials and Methods:  We conducted a content analysis of observation notes and patient comments collected during the testing of two top commercially available diabetes apps as part of a crossover randomized trial. Participants were adult patients with type 1 or type 2 diabetes on insulin therapy. We analyzed field notes and transcriptions of audio recordings. Open coding derived categories of usability issues, which then were grouped into themes and subthemes on usability problem types.  Results:  A total of 92 adult Android smartphone users were recruited online (e.g., Facebook) and in-person postings. Three major themes described problems with data input, app report display and presentation, and self-learning options. Data entry modes were problematic because of overcrowded app screens, complicated ""save data"" steps, and a lack of data entry confirmation. The app icons, wording, entry headings, and analysis reports were not intuitive to understand. Participants wanted self-learning options (e.g., pop-up messages) during app use.  Conclusions:  Patient testing of top commercially available diabetes apps revealed key usability design issues in data entry, app report, and self-help learning options. Good app training for patients is necessary for both initial use and long-term use of diabetes apps to support self-management.",2020,Good app training for patients is necessary for both initial use and long-term use of diabetes apps to support self-management.,"['92 adult Android smartphone users were recruited online (e.g., Facebook) and in-person postings', 'adult patients with diabetes who were testing diabetes apps for the first time', 'Participants were adult patients with type 1 or type 2 diabetes on insulin therapy']",[],[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0336541', 'cui_str': 'Android'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]",[],[],92.0,0.036659,Good app training for patients is necessary for both initial use and long-term use of diabetes apps to support self-management.,"[{'ForeName': 'Helen N C', 'Initials': 'HNC', 'LastName': 'Fu', 'Affiliation': 'Center for Aging Science and Care Innovation, School of Nursing, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Jin', 'Affiliation': 'Institute for Health Informatics, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Terrence J', 'Initials': 'TJ', 'LastName': 'Adam', 'Affiliation': 'Institute for Health Informatics, University of Minnesota, Minneapolis, Minnesota, USA.'}]",Telemedicine journal and e-health : the official journal of the American Telemedicine Association,['10.1089/tmj.2020.0128']
2430,32798059,"Impact of SLCO4C1 Genotypes, Creatinine, and Spironolactone on Digoxin Population Pharmacokinetic Variables in Patients With Cardiac Insufficiency.","PURPOSE


This study aimed to utilize a population pharmacokinetic method to obtain information about the influence of covariates on the in vivo behavior of digoxin in patients with cardiac insufficiency.
METHODS


A total of 228 therapeutic drug monitoring concentrations were retrospectively collected from 176 inpatients. The patients were randomly divided into a modeling group (n = 126) and a validation group (n = 50). The first-order absorption one-compartment model was used to develop a population pharmacokinetic model from a nonlinear mixed effects modeling approach. Sixteen single nucleotide polymorphisms involved in the pharmacokinetic variables of digoxin were identified by using the MassARRAY system. Various demographic parameters, biochemical test values, concomitant medications, and genetic variants were investigated.
FINDINGS


The typical population value of digoxin CL/F was 5.06 L/h, and the volume of distribution was 211.82 L. The drug CL/F was significantly related to serum creatinine, in a combination of spironolactone and SLCO4C1 genotypes of 2 variants (rs3114660 and rs3114661). Results of model evaluation and internal/external validation indicated a stable and precise performance of the final model.
IMPLICATIONS


For the first time, 2 single nucleotide polymorphisms (rs3114660 and rs3114661) in SLCO4C1 were found to significantly affect the elimination of digoxin in vivo. The final population model may be useful for the individualized dosing of digoxin for patients with cardiac insufficiency.",2020,"The drug CL/F was significantly related to serum creatinine, in a combination of spironolactone and SLCO4C1 genotypes of 2 variants (rs3114660 and rs3114661).","['A total of 228 therapeutic drug monitoring concentrations were retrospectively collected from 176 inpatients', 'patients with cardiac insufficiency', 'Patients With Cardiac Insufficiency']","['digoxin', 'SLCO4C1 Genotypes, Creatinine, and Spironolactone']",['pharmacokinetic variables of digoxin'],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1720825', 'cui_str': 'Therapeutic Drug Monitoring'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]","[{'cui': 'C0012265', 'cui_str': 'Digoxin'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0037982', 'cui_str': 'Spironolactone'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0012265', 'cui_str': 'Digoxin'}]",,0.0185196,"The drug CL/F was significantly related to serum creatinine, in a combination of spironolactone and SLCO4C1 genotypes of 2 variants (rs3114660 and rs3114661).","[{'ForeName': 'Pengqiang', 'Initials': 'P', 'LastName': 'Du', 'Affiliation': ""Department of Pharmacy, Fuwai Central China Cardiovascular Hospital, Central China Fuwai Hospital of Zhengzhou University, Henan Provincial People's Hospital, Zhengzhou, Henan, China.""}, {'ForeName': 'Aifeng', 'Initials': 'A', 'LastName': 'Wang', 'Affiliation': ""Department of Pharmacy, Fuwai Central China Cardiovascular Hospital, Central China Fuwai Hospital of Zhengzhou University, Henan Provincial People's Hospital, Zhengzhou, Henan, China.""}, {'ForeName': 'Yongcheng', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': ""Department of Pharmacy, Fuwai Central China Cardiovascular Hospital, Central China Fuwai Hospital of Zhengzhou University, Henan Provincial People's Hospital, Zhengzhou, Henan, China.""}, {'ForeName': 'Ao', 'Initials': 'A', 'LastName': 'Jia', 'Affiliation': ""Department of Pharmacy, Fuwai Central China Cardiovascular Hospital, Central China Fuwai Hospital of Zhengzhou University, Henan Provincial People's Hospital, Zhengzhou, Henan, China.""}, {'ForeName': 'Yafei', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""Department of Pharmacy, Fuwai Central China Cardiovascular Hospital, Central China Fuwai Hospital of Zhengzhou University, Henan Provincial People's Hospital, Zhengzhou, Henan, China.""}, {'ForeName': 'Xingang', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Pharmacy, Beijing Friendship Hospital, Capital Medical University, Beijing, China. Electronic address: lxg198320022003@163.com.'}]",Clinical therapeutics,['10.1016/j.clinthera.2020.07.011']
2431,32804282,Shoulder amplitude movement does not influence postoperative wound complications after breast cancer surgery: a randomized clinical trial.,"PURPOSE


The goal of this study is to evaluate the influence of shoulder exercises with restricted amplitude movement (RAM) or free amplitude movement (FAM) performed from the first postoperative day (1st POD) on the incidence of surgical wound complications (SWC) in breast cancer.
METHODS


This study comprises a randomized clinical trial with an intention-to-treat analysis including 465 women aged 18 to 79, who underwent curative surgery for breast cancer. Participants were submitted to perform free amplitude movement (FAM) or restricted amplitude movement (RAM) shoulder exercises, until the 30th postoperative day. The outcome measures were the SWC: seroma, dehiscence, necrosis, infection, hematoma and bruise.
RESULTS


461 participants completed the follow-up. Thirty days after surgery, 63.8% of the women presented some surgical wound complication, with necrosis (39.3%) and seroma (30.8%) as the most frequent. No statistically significant differences in SWC according to postoperative amplitude shoulder exercise (FAM vs RAM), even after a stratified analysis by type of surgery (segmentectomy vs mastectomy) or axillary approach (axillary lymphadenectomy versus sentinel lymph node biopsy) were observed.
CONCLUSION


FAM exercises do not increase the incidence of postoperative wound complications compared to RAM exercises.
TRIAL REGISTRATION


NCT03796845.",2020,"No statistically significant differences in SWC according to postoperative amplitude shoulder exercise (FAM vs RAM), even after a stratified analysis by type of surgery (segmentectomy vs mastectomy) or axillary approach (axillary lymphadenectomy versus sentinel lymph node biopsy) were observed.
","['breast cancer', '465 women aged 18 to 79, who underwent curative surgery for breast cancer', 'breast cancer surgery', '461 participants completed the follow-up']","['free amplitude movement (FAM) or restricted amplitude movement (RAM) shoulder exercises', 'FAM exercises', 'Shoulder amplitude movement', 'shoulder exercises with restricted amplitude movement (RAM) or free amplitude movement (FAM']","['postoperative wound complications', 'seroma', 'surgical wound complications (SWC', 'surgical wound complication, with necrosis', 'SWC: seroma, dehiscence, necrosis, infection, hematoma and bruise']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0454323', 'cui_str': 'Shoulder exercises'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}]","[{'cui': 'C0877305', 'cui_str': 'Postoperative wound complication'}, {'cui': 'C0262627', 'cui_str': 'Seroma'}, {'cui': 'C0332803', 'cui_str': 'Surgical wound'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0027540', 'cui_str': 'Necrosis'}, {'cui': 'C0149663', 'cui_str': 'Dehiscence'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0009938', 'cui_str': 'Contusion'}]",465.0,0.162905,"No statistically significant differences in SWC according to postoperative amplitude shoulder exercise (FAM vs RAM), even after a stratified analysis by type of surgery (segmentectomy vs mastectomy) or axillary approach (axillary lymphadenectomy versus sentinel lymph node biopsy) were observed.
","[{'ForeName': 'Clarice Gomes Chagas', 'Initials': 'CGC', 'LastName': 'Teodózio', 'Affiliation': 'Clinical Research Division, Brazilian National Cancer Institute, Rio de Janeiro, Brazil.'}, {'ForeName': 'Liz de Oliveira', 'Initials': 'LO', 'LastName': 'Marchito', 'Affiliation': 'Clinical Research Division, Brazilian National Cancer Institute, Rio de Janeiro, Brazil.'}, {'ForeName': 'Erica Alves Nogueira', 'Initials': 'EAN', 'LastName': 'Fabro', 'Affiliation': 'Physiotherapy Department, Brazilian National Cancer Institute, Rio de Janeiro, Brazil.'}, {'ForeName': 'Flávia Oliveira', 'Initials': 'FO', 'LastName': 'Macedo', 'Affiliation': 'Physiotherapy Department, Brazilian National Cancer Institute, Rio de Janeiro, Brazil.'}, {'ForeName': 'Suzana Sales', 'Initials': 'SS', 'LastName': 'de Aguiar', 'Affiliation': 'Clinical Research Division, Brazilian National Cancer Institute, Rio de Janeiro, Brazil.'}, {'ForeName': 'Luiz Claudio Santos', 'Initials': 'LCS', 'LastName': 'Thuler', 'Affiliation': 'Clinical Research Division, Brazilian National Cancer Institute, Rio de Janeiro, Brazil.'}, {'ForeName': 'Anke', 'Initials': 'A', 'LastName': 'Bergmann', 'Affiliation': 'Clinical Research Division, Brazilian National Cancer Institute, Rio de Janeiro, Brazil. abergmann@inca.gov.br.'}]",Breast cancer research and treatment,['10.1007/s10549-020-05826-9']
2432,32800005,'We got more than we expected.'  Older people's experiences of falls-prevention exercise interventions and implications for practice; a qualitative study.,"AIM


To explore the experiences of older adults participating in strength and balance exercise programmes and understand participants' rationale for programme uptake and completion.
BACKGROUND


Regular physical activity, specifically strength and balance exercises, has been shown to improve health and well-being and reduce the risk of falling in older adults. With the number of people living into older age increasing, understanding older people's experiences of strength and balance programmes and what encourages their take-up and completion is extremely important. This paper reports on the qualitative experiences of older adults that previously participated in ProAct65+, a randomised controlled trial of Falls Management Exercise (FaME) programme and Otago Exercise Programme (OEP) versus usual care.
METHODS


Ten general practices in Nottinghamshire and Derbyshire, England, who participated in the ProAct65+ trial were approached to take part. Using maximum variation sampling (age, gender, falls history, fear of falling and trial arm) we recruited, via the practices, 30 people that had participated in the FaME (n = 15) or OEP (n = 15) trial arms. Participants were interviewed in their own homes. Interviews were audio-recorded, transcribed verbatim and thematically analysed.
FINDINGS


We identified five themes: choice of exercise programme; commitment, discipline and motivation; benchmarking, feedback and monitoring; benefits of the exercise programmes and reactions to the end of the programmes. There were four sub-themes within the benefits theme: pleasure and boredom, social interaction and isolation, physical benefits, and knowledge and understanding.This study has outlined the experiences and identified specific barriers and facilitators to uptake and completion of falls-prevention exercises by older adults. The perspective and experiences of these participants is important if programmes are to be designed to meet the needs of the target population. Insights from this study will enable commissioners to develop and provide appropriate falls-prevention exercise programmes that encourage high uptake and programme completion.",2019,"With the number of people living into older age increasing, understanding older people's experiences of strength and balance programmes and what encourages their take-up and completion is extremely important.","[""Older people's experiences of falls"", 'older adults', '30 people that had participated in the FaME (n = 15) or OEP (n = 15) trial arms', 'Ten general practices in Nottinghamshire and Derbyshire, England, who participated in the ProAct65+ trial were approached to take part', 'older adults that previously participated in ProAct65', 'older adults participating in', 'Participants were interviewed in their own homes']","['Falls Management Exercise (FaME) programme and Otago Exercise Programme (OEP) versus usual care', 'prevention exercise interventions', 'strength and balance exercise programmes']","['pleasure and boredom, social interaction and isolation, physical benefits, and knowledge and understanding']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0454870', 'cui_str': 'Nottinghamshire'}, {'cui': 'C0454848', 'cui_str': 'Derbyshire'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]","[{'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0150219', 'cui_str': 'Balance exercises'}]","[{'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0006019', 'cui_str': 'Boredom'}, {'cui': 'C0037420', 'cui_str': 'Interaction with others'}, {'cui': 'C0037421', 'cui_str': 'Social isolation'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}]",10.0,0.0486069,"With the number of people living into older age increasing, understanding older people's experiences of strength and balance programmes and what encourages their take-up and completion is extremely important.","[{'ForeName': 'Natasher', 'Initials': 'N', 'LastName': 'Lafond', 'Affiliation': 'Research Fellow, University of Nottingham, School of Medicine, United Kingdom.'}, {'ForeName': 'Asiya', 'Initials': 'A', 'LastName': 'Maula', 'Affiliation': 'ACF GPR, University of Nottingham, School of Medicine, United Kingdom.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Iliffe', 'Affiliation': 'Professor of Primary Care for Older People (Now Emeritus Professor), University College London, Research Department of Primary Care & Population Health, United Kingdom.'}, {'ForeName': 'Kavita', 'Initials': 'K', 'LastName': 'Vedhara', 'Affiliation': 'Professor of Health Psychology, University of Nottingham, School of Medicine, United Kingdom.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Audsley', 'Affiliation': 'Posdoctoral fellow, University of Nottingham, School of Medicine, United Kingdom.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Kendrick', 'Affiliation': 'Professor of Primary Care Research, University of Nottingham, School of Medicine, United Kingdom.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Orton', 'Affiliation': 'Associate Professor and Consultant in Public Health, University of Nottingham, School of Medicine, United Kingdom.'}]",Primary health care research & development,['10.1017/S1463423619000379']
2433,32767902,Progress testing anytime and anywhere - Does a mobile-learning approach enhance the utility of a large-scale formative assessment tool?,"BACKGROUND


The widespread use of mobile devices among students favors the use of mobile learning scenarios at universities. In this study, we explore whether a time- and location-independent variant of a formative progress test has an impact on the students' acceptance, its validity and reliability and if there is a difference in response processes between the two exam conditions.
METHODS


Students were randomly assigned to two groups of which one took the test free of local or temporal fixations, while the other group took the test at the local testing center under usual examination conditions. Beside the generated test data, such as test score, time-on-test, and semester status, students also evaluated the settings.
RESULTS


While there was no significant effect on the test score between the two groups, students in the mobile group spent more time on the test and were more likely to use the help of books or online resources. The results of the evaluation show that the acceptability among students is increased by a mobile version of the formative progress test.
CONCLUSIONS


The results suggest that the acceptance and motivation to participate in formative tests is enhanced by lifting local and temporal restrictions. The mobile version nonetheless does not have an impact on the students' performance.",2020,"The results of the evaluation show that the acceptability among students is increased by a mobile version of the formative progress test.
",['Students'],[],[],"[{'cui': 'C0038492', 'cui_str': 'Student'}]",[],[],,0.0359183,"The results of the evaluation show that the acceptability among students is increased by a mobile version of the formative progress test.
","[{'ForeName': 'Yassin', 'Initials': 'Y', 'LastName': 'Karay', 'Affiliation': ""Dean's Office for Student Affairs, Faculty of Medicine, University of Cologne, Cologne, Germany.""}, {'ForeName': 'Birger', 'Initials': 'B', 'LastName': 'Reiss', 'Affiliation': ""Dean's Office for Student Affairs, Faculty of Medicine, University of Cologne, Cologne, Germany.""}, {'ForeName': 'Stefan K', 'Initials': 'SK', 'LastName': 'Schauber', 'Affiliation': 'Centre for Health Sciences Education, Faculty of Medicine, University of Oslo, Oslo, Norway.'}]",Medical teacher,['10.1080/0142159X.2020.1798910']
2434,32778913,"Acute mechanical, physiological and perceptual responses in older men to traditional-set or different cluster-set configuration resistance training protocols.","PURPOSE


The aims of this study were to compare mechanical outputs (i.e. power and impulse), physiological (i.e. heart rate) and perceptual (i.e. effort and fatigue) responses in older men to traditional-set or different cluster-set configuration resistance training protocols.
METHODS


In a randomized cross-over design, 20 healthy old men (aged 67.2 ± 2.1 years) completed four resistance training sessions using the back squat exercise loaded with optimal power loads. Training configurations were: traditional (TRA), three sets of six repetitions with 120-s rest between each set; Cluster-set 1 (CLU1), 24 single-repetition clusters with 10 s of rest after every cluster; Cluster-set 2 (CLU2), 12 double-repetition clusters with 20-s rest after every cluster; and Cluster-set 4 (CLU4), 6 quadruple-repetition clusters with 40-s rest after every cluster.
RESULTS


Cluster-set configurations resulted in greater power outputs compared to traditional-set configuration (range 2.6-9.2%, all p [Formula: see text] 0.07 for main effect and protocol [Formula: see text] set interactions). CLU1 and CLU2 induced higher heart rate (range 7.1-10.5%, all p < 0.001 for main effect and protocol [Formula: see text] set interactions), lower rating of perceived exertion (range - 1.3 to - 3.2 AU, all p [Formula: see text] 0.006 for pairwise comparisons) and lower ratings of fatigue (range - 0.15 to - 4 AU, all p [Formula: see text] 0.012 for pairwise comparisons) compared to TRA and CLU4. Finally, an absolute preference for CLU2 was reported.
CONCLUSIONS


Findings presented here support the prescription of CLU2 as an optimal resistance training configuration for trained older men using the back squat.",2020,"CLU1 and CLU2 induced higher heart rate (range 7.1-10.5%, all p < 0.001 for main effect and protocol [Formula: see text] set interactions), lower rating of perceived exertion (range - 1.3 to - 3.2 AU,","['trained older men using the back squat', '20 healthy old men (aged 67.2\u2009±\u20092.1\xa0years', 'older men to traditional-set or different cluster-set configuration resistance training protocols', 'older men']","['CLU1 and CLU2', 'resistance training sessions using the back squat exercise loaded with optimal power loads']","['heart rate', 'lower ratings of fatigue', 'mechanical outputs (i.e. power and impulse), physiological (i.e. heart rate) and perceptual (i.e. effort and fatigue) responses', 'Acute mechanical, physiological and perceptual responses']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C4068876', 'cui_str': '2.1'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0449830', 'cui_str': 'With configuration'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}, {'cui': 'C0443235', 'cui_str': 'Impulse'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]",,0.043265,"CLU1 and CLU2 induced higher heart rate (range 7.1-10.5%, all p < 0.001 for main effect and protocol [Formula: see text] set interactions), lower rating of perceived exertion (range - 1.3 to - 3.2 AU,","[{'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Dello Iacono', 'Affiliation': 'University of the West of Scotland (School of Health and Life Sciences), Hamilton, UK. antonio.delloiacono@uws.ac.uk.'}, {'ForeName': 'Domenico', 'Initials': 'D', 'LastName': 'Martone', 'Affiliation': ""Universita' Degli Studi di Napoli (Dipartimento di Science Motorie e Benessere), Naples, Italy.""}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Hayes', 'Affiliation': 'University of the West of Scotland (School of Health and Life Sciences), Hamilton, UK.'}]",European journal of applied physiology,['10.1007/s00421-020-04453-y']
2435,32778992,Integrating Tobacco Prevention Skills into an Evidence-Based Intervention for Adolescents with ADHD: Results from a Pilot Efficacy Randomized Controlled Trial.,"Adolescents with attention-deficit/hyperactivity disorder (ADHD) are at high risk for tobacco use, but tobacco use prevention strategies are not regularly incorporated into evidence-based ADHD interventions. We conducted a pilot randomized-controlled trial to determine the feasibility of integrating tobacco use prevention skills into a behavioral treatment for ADHD and to provide preliminary efficacy data comparing a combined (ADHD + tobacco) intervention (N = 40) to an ADHD only intervention (N = 23) on tobacco risk outcomes. Sixty-three adolescents (72% male; 13-17 years) with ADHD and their caregivers were randomly assigned to condition and families were masked to condition. Parent and adolescent ratings were collected at baseline, immediate post-intervention, and at 3- and 9-month follow-up assessments. The combined intervention was (1) implemented with high fidelity (94%), (2) well received by parents and adolescents as evidenced by high levels of treatment attendance (82%) and satisfaction with the intervention, and (3) associated with parent- and adolescent-reported reductions in tobacco use risk. Relative to the ADHD intervention, the combined intervention buffered against increases in tobacco risk, including reduced intentions to smoke and maladaptive social normative beliefs, and increased parental control, family cohesion, and family communication about substance use. Effect sizes at post-treatment were in the small to moderate range. Overall, this study provides preliminary support for a parent-adolescent behavioral treatment supplemented with family-based tobacco prevention strategies. This approach targets families already in treatment for ADHD, reducing barriers that occur when families attend multi-session prevention programs in addition to ADHD treatment.",2020,"The combined intervention was (1) implemented with high fidelity (94%), (2) well received by parents and adolescents as evidenced by high levels of treatment attendance (82%) and satisfaction with the intervention, and (3) associated with parent- and adolescent-reported reductions in tobacco use risk.","['Adolescents with ADHD', 'Adolescents with attention-deficit/hyperactivity disorder (ADHD', 'Sixty-three adolescents (72% male; 13-17\xa0years) with ADHD and their caregivers']",['combined (ADHD + tobacco) intervention'],"['tobacco risk, including reduced intentions to smoke and maladaptive social normative beliefs, and increased parental control, family cohesion, and family communication about substance use', 'Parent and adolescent ratings']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C4319614', 'cui_str': '63'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]",,0.0726723,"The combined intervention was (1) implemented with high fidelity (94%), (2) well received by parents and adolescents as evidenced by high levels of treatment attendance (82%) and satisfaction with the intervention, and (3) associated with parent- and adolescent-reported reductions in tobacco use risk.","[{'ForeName': 'Rosalie', 'Initials': 'R', 'LastName': 'Corona', 'Affiliation': 'Department of Psychology, Virginia Commonwealth University, 806 West Franklin Street, Box 842018, Richmond, VA, 23284-2018, USA. racorona@vcu.edu.'}, {'ForeName': 'Melissa R', 'Initials': 'MR', 'LastName': 'Dvorsky', 'Affiliation': 'Department of Psychology, Virginia Commonwealth University, 806 West Franklin Street, Box 842018, Richmond, VA, 23284-2018, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Romo', 'Affiliation': 'Department of Psychology, Virginia Commonwealth University, 806 West Franklin Street, Box 842018, Richmond, VA, 23284-2018, USA.'}, {'ForeName': 'Amanda M', 'Initials': 'AM', 'LastName': 'Parks', 'Affiliation': 'Department of Psychology, Virginia Commonwealth University, 806 West Franklin Street, Box 842018, Richmond, VA, 23284-2018, USA.'}, {'ForeName': 'Elizaveta', 'Initials': 'E', 'LastName': 'Bourchtein', 'Affiliation': 'Department of Psychology, Virginia Commonwealth University, 806 West Franklin Street, Box 842018, Richmond, VA, 23284-2018, USA.'}, {'ForeName': 'Zoe R', 'Initials': 'ZR', 'LastName': 'Smith', 'Affiliation': 'Department of Psychology, Virginia Commonwealth University, 806 West Franklin Street, Box 842018, Richmond, VA, 23284-2018, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Avila', 'Affiliation': 'Department of Psychology, Virginia Commonwealth University, 806 West Franklin Street, Box 842018, Richmond, VA, 23284-2018, USA.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Langberg', 'Affiliation': 'Department of Psychology, Virginia Commonwealth University, 806 West Franklin Street, Box 842018, Richmond, VA, 23284-2018, USA.'}]",Journal of abnormal child psychology,['10.1007/s10802-020-00689-6']
2436,32657505,Sebelipase alfa for lysosomal acid lipase deficiency: 5-year treatment experience from a phase 2 open-label extension study.,"BACKGROUND AND AIMS


Lysosomal acid lipase deficiency is characterized by hepatomegaly and dyslipidaemia, which can lead to cirrhosis and premature atherosclerosis. Sebelipase alfa is an approved recombinant human lysosomal acid lipase. In an open-label extension study of adults with lysosomal acid lipase deficiency (LAL-CL04), sebelipase alfa treatment for 1 year reduced serum transaminase levels and liver fat content and improved serum lipid levels.
METHODS


Final data from LAL-CL04 are reported herein for patients who received sebelipase alfa infusions (1.0 or 3.0 mg/kg every other week) for up to 5 years.
RESULTS


Of 8 patients enrolled, 7 received sebelipase alfa for 224-260 weeks; 1 was lost to follow-up. Median baseline levels of alanine aminotransferase and aspartate aminotransferase (81.5 and 50.0 U/L, respectively) were decreased through the end-of-study visit (54.0 and 34.0 U/L). Median low-density lipoprotein cholesterol decreased from 113 to 78 mg/dL, total cholesterol decreased from 171 to 132 mg/dL, and high-density lipoprotein cholesterol increased from 37 to 42 mg/dL. Most treatment-emergent adverse events were nonserious (99%), mild/moderate (98%) and unrelated to sebelipase alfa (87%); no patient discontinued as a result of treatment-emergent adverse events. One patient had 2 serious treatment-emergent adverse events (cholecystitis and cholelithiasis; assessed as unlikely related to sebelipase alfa). Two patients had 20 nonserious infusion-associated reactions in weeks 6-38; all were manageable. One patient tested positive for antidrug antibodies (single occurrence).
CONCLUSIONS


Sebelipase alfa was well tolerated and improved serum transaminase and lipid levels for up to 5 years in adults with lysosomal acid lipase deficiency.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov record NCT01488097.",2020,"CONCLUSIONS


Sebelipase alfa was well tolerated and improved serum transaminase and lipid levels for up to 5 years in adults with lysosomal acid lipase deficiency.
","['adults with lysosomal acid lipase deficiency (LAL-CL04', 'adults with lysosomal acid lipase deficiency', 'Of 8 patients enrolled']","['Sebelipase alfa', 'sebelipase alfa infusions']","['Median baseline levels of alanine aminotransferase and aspartate aminotransferase', 'tolerated and improved serum transaminase and lipid levels', 'total cholesterol', 'high-density lipoprotein cholesterol', 'serum transaminase levels and liver fat content and improved serum lipid levels', 'Median low-density lipoprotein cholesterol']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043208', 'cui_str': ""Wolman's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C4050579', 'cui_str': 'sebelipase alfa'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferase'}, {'cui': 'C0428460', 'cui_str': 'Lipid level - finding'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0428462', 'cui_str': 'Measurement of serum lipid level'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}]",8.0,0.0400227,"CONCLUSIONS


Sebelipase alfa was well tolerated and improved serum transaminase and lipid levels for up to 5 years in adults with lysosomal acid lipase deficiency.
","[{'ForeName': 'Vĕra', 'Initials': 'V', 'LastName': 'Malinová', 'Affiliation': ""Department for Metabolic Diseases, Children's Clinic, General Faculty Hospital and First Faculty of Medicine of Charles University in Prague, Prague, Czech Republic.""}, {'ForeName': 'Manisha', 'Initials': 'M', 'LastName': 'Balwani', 'Affiliation': 'Department of Genetics and Genomic Sciences and Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Reena', 'Initials': 'R', 'LastName': 'Sharma', 'Affiliation': 'Department of Endocrinology and Metabolic Medicine, Salford Royal Foundation NHS Trust, Salford, UK.'}, {'ForeName': 'Jean-Baptiste', 'Initials': 'JB', 'LastName': 'Arnoux', 'Affiliation': 'Department of Inherited Metabolic Diseases, Hôpital Necker-Enfants Malades, Paris, France.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Kane', 'Affiliation': 'Department of Medicine, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Chester B', 'Initials': 'CB', 'LastName': 'Whitley', 'Affiliation': 'Advanced Therapies Program, and Gene Therapy Center, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Sachin', 'Initials': 'S', 'LastName': 'Marulkar', 'Affiliation': 'Alexion Pharmaceuticals, Inc., Boston, MA, USA.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Abel', 'Affiliation': 'Alexion Pharmaceuticals, Inc., Boston, MA, USA.'}]",Liver international : official journal of the International Association for the Study of the Liver,['10.1111/liv.14603']
2437,32789625,"Awareness, Willingness, and Perceived Efficacy of Pre-exposure Prophylaxis among Adolescent Sexual Minority Males.","Despite the approval of PrEP for adolescents by the FDA in 2018, little is known about the awareness and attitudes about PrEP use among adolescent sexual minority males, who are at the greatest risk for HIV. We analyzed baseline data from the MyPEEPS Mobile study, a multi-site randomized controlled trial evaluating the effectiveness of a mobile behavioral HIV prevention intervention. A substantial proportion (68.2%) of study participants (ages 13-18) had previously heard about PrEP, and an overwhelming majority (90.8%) reported willingness to take PrEP, to prevent HIV. On the other hand, only about one third (34.6%) of participants indicated that taking a daily HIV pill would be ""very"" or ""completely"" effective in preventing HIV when having sex without a condom. These findings suggest that high awareness and willingness to use PrEP across various adolescent subgroups present opportunities for increased PrEP advocacy among this young age group.",2020,"A substantial proportion (68.2%) of study participants (ages 13-18) had previously heard about PrEP, and an overwhelming majority (90.8%) reported willingness to take PrEP, to prevent HIV.","['adolescent sexual minority males', 'Adolescent Sexual Minority Males']",['mobile behavioral HIV prevention intervention'],[],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C4277573', 'cui_str': 'Lesbigay Persons'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0544438,"A substantial proportion (68.2%) of study participants (ages 13-18) had previously heard about PrEP, and an overwhelming majority (90.8%) reported willingness to take PrEP, to prevent HIV.","[{'ForeName': 'Alvin', 'Initials': 'A', 'LastName': 'Gordián-Arroyo', 'Affiliation': 'Columbia University, Mailman School of Public Health, New York, NY, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Garofalo', 'Affiliation': ""Department of Pediatrics, Northwestern's Feinberg School of Medicine, Chicago, IL, USA.""}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Kuhns', 'Affiliation': ""Department of Pediatrics, Northwestern's Feinberg School of Medicine, Chicago, IL, USA.""}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Pearson', 'Affiliation': 'University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Josh', 'Initials': 'J', 'LastName': 'Bruce', 'Affiliation': 'Birmingham AIDS Outreach, Birmingham, AL, USA.'}, {'ForeName': 'D Scott', 'Initials': 'DS', 'LastName': 'Batey', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Asa', 'Initials': 'A', 'LastName': 'Radix', 'Affiliation': 'Callen-Lorde Community Health Center, New York, NY, USA.'}, {'ForeName': 'Uri', 'Initials': 'U', 'LastName': 'Belkind', 'Affiliation': 'Callen-Lorde Community Health Center, New York, NY, USA.'}, {'ForeName': 'Marco A', 'Initials': 'MA', 'LastName': 'Hidalgo', 'Affiliation': ""Keck School of Medicine of the University of Southern California/Children's Hospital Los Angeles, Los Angeles, CA, USA.""}, {'ForeName': 'Sabina', 'Initials': 'S', 'LastName': 'Hirshfield', 'Affiliation': 'SUNY Downstate Health Sciences University, Department of Medicine, Brooklyn, NY, USA.'}, {'ForeName': 'Eric W', 'Initials': 'EW', 'LastName': 'Schrimshaw', 'Affiliation': 'University of Central Florida, College of Medicine, Orlando, FL, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Schnall', 'Affiliation': 'Columbia University, School of Nursing, New York, NY, USA. rb897@columbia.edu.'}]",Journal of urban health : bulletin of the New York Academy of Medicine,['10.1007/s11524-020-00447-5']
2438,32787371,The application of thromboelastography in risk stratification for selective thromboembolism prophylaxis after total joint arthroplasty in Chinese: a randomized controlled trial.,"BACKGROUND


As Asian populations, Chinese have a lower rate of high-risk gene mutations in venous thrombosis. Therefore, individual patient risk assessment, rather than a ""blanket policy"", is considered the best thromboembolism prophylaxis for Chinese. The purpose of this study was to evaluate the effectiveness and safety of selective thromboembolism prophylaxis compared with conventional thromboembolism prophylaxis by risk stratification with thromboelastography (TEG) after joint arthroplasty in Chinese.
METHODS


Between August 2016 to August 2017, Chinese patients who underwent hip or knee arthroplasty were randomly divided into a selective anticoagulation group (SAG) and a conventional anticoagulation group (CAG). Participants and outcome assessors were blinded. In the SAG, an anticoagulant was used when TEG indicated hypercoagulability; while in the CAG, an anticoagulant was regularly used until one month after surgery. Outcome evaluation included effectiveness (defined as the incidence of VTE), and safety (defined as the incidence of bleeding events, poor wound healing, blood loss, and infection).
RESULTS


A total of 197 patients (79 in the SAG and 118 in the CAG) were included in the study. There was 1 case of deep vein thrombosis (DVT) in the SAG and 2 cases of DVT in the CAG, but there was no significant difference between the two groups. Hidden blood loss in the SAG was 707.4±539.8 mL and hidden blood loss in the CAG was 617±565.0 mL, respectively (P>0.05). No significant difference was observed in perioperative blood loss between the SAG and the CAG (1,024.9±597.9 and 1,139.3±620.9 mL, respectively). Volume of blood transfusion was 92.4±270.2 mL in the SAG and 224.6±416.3 mL in the CAG, respectively, while rate of transfusion was 13.9% in the SAG and 33.9% in the CAG, respectively, which were significantly different between the two groups (P<0.05).
CONCLUSIONS


In Chinese patients who underwent hip or knee arthroplasty, the efficacy of selective anticoagulation using TEG in risk stratification was comparable to that of conventional anticoagulation. Furthermore, the safety of selective anticoagulant prophylaxis was superior to that of conventional anticoagulant prophylaxis.",2020,"In Chinese patients who underwent hip or knee arthroplasty, the efficacy of selective anticoagulation using TEG in risk stratification was comparable to that of conventional anticoagulation.","['197 patients (79 in the SAG and 118 in the CAG) were included in the study', 'selective thromboembolism prophylaxis after total joint arthroplasty in Chinese', 'Between August 2016 to August 2017, Chinese patients who underwent hip or knee arthroplasty', 'Chinese patients who underwent hip or knee arthroplasty', 'joint arthroplasty in Chinese']","['thromboelastography (TEG', 'selective thromboembolism prophylaxis', 'conventional thromboembolism prophylaxis', 'selective anticoagulation group (SAG) and a conventional anticoagulation group (CAG', 'thromboelastography']","['deep vein thrombosis (DVT', 'Hidden blood loss', 'effectiveness and safety', 'rate of transfusion', 'Volume of blood transfusion', 'hypercoagulability', 'perioperative blood loss', 'effectiveness (defined as the incidence of VTE), and safety (defined as the incidence of bleeding events, poor wound healing, blood loss, and infection']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0199242', 'cui_str': 'Anticoagulant prophylaxis'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003893', 'cui_str': 'Arthroplasty'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0040017', 'cui_str': 'Thromboelastography'}, {'cui': 'C0199242', 'cui_str': 'Anticoagulant prophylaxis'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0205262', 'cui_str': 'Occult'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0398623', 'cui_str': 'Thrombophilia'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0630906', 'cui_str': 'vinyltriethoxysilane'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]",197.0,0.0498045,"In Chinese patients who underwent hip or knee arthroplasty, the efficacy of selective anticoagulation using TEG in risk stratification was comparable to that of conventional anticoagulation.","[{'ForeName': 'Ziming', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': ""Department of Orthopedics, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China; Centre for Orthopaedic Translational Research, Medical School, University of Western Australia, Nedlands, Australia.""}, {'ForeName': 'Yuanchen', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': ""Department of Orthopedics, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.""}, {'ForeName': 'Qingtian', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': ""Department of Orthopedics, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.""}, {'ForeName': 'Zhantao', 'Initials': 'Z', 'LastName': 'Deng', 'Affiliation': ""Department of Orthopedics, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China. dengzhantao_med@163.com.""}, {'ForeName': 'Qiujian', 'Initials': 'Q', 'LastName': 'Zheng', 'Affiliation': ""Department of Orthopedics, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China. ZQJzqj666@yeah.net.""}]",Annals of palliative medicine,['10.21037/apm-19-385']
2439,32787595,The efficacy of transversus abdominis plane block for postoperative analgesia in laparoscopic cholecystectomy cases: a retrospective evaluation of 515 patients.,"OBJECTIVE


To compare patients that received intravenous (i.v.) analgesics with those that received transversus abdominis plane (TAP) block for pain relief after laparoscopic cholecystectomy.
METHODS


This retrospective study enrolled patients that had undergone laparoscopic cholecystectomy and divided them into two groups: the i.v. analgesic group (controls; group A) and the TAP block group (group T). Data retrieved from the medical records included postoperative visual analogue scale (VAS) pain scores, duration of intensive care unit (ICU) stay, total hospital stay, additional analgesic requirements and the occurrence of nausea and vomiting.
RESULTS


A total of 515 patients were included (group A,  n  = 247; group T,  n  = 268). Postoperative VAS pain scores at 0, 2, 4 and 6 h and the need for additional analgesics were significantly lower in group T than in group A. Postoperative VAS pain scores at 12 and 24 h were significantly higher in group T than in group A. Postoperative nausea and vomiting were significantly lower in group T than in group A. The rate of ICU admission in group T was significantly lower than in group A.
CONCLUSIONS


Effective postoperative analgesia can be achieved with TAP block and undesirable effects can be reduced.",2020,"Postoperative VAS pain scores at 0, 2, 4 and 6 h and the need for additional analgesics were significantly lower in group T than in group A. Postoperative VAS pain scores at 12 and 24 h were significantly higher in group T than in group A. Postoperative nausea and vomiting were significantly lower in group T than in group A.","['515 patients were included (group A,  n \u2009=\u2009247; group T,  n \u2009=\u2009268', 'enrolled patients that had undergone', 'laparoscopic cholecystectomy cases', '515 patients']","['transversus abdominis plane', 'transversus abdominis plane block', 'TAP) block', 'intravenous (i.v', 'laparoscopic cholecystectomy', 'TAP block']","['need for additional analgesics', 'rate of ICU admission', 'pain relief', 'Postoperative nausea and vomiting', 'Postoperative VAS pain scores', 'postoperative visual analogue scale (VAS) pain scores, duration of intensive care unit (ICU) stay, total hospital stay, additional analgesic requirements and the occurrence of nausea and vomiting']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0036669', 'cui_str': 'Group T'}, {'cui': 'C4517673', 'cui_str': '268'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0868928', 'cui_str': 'Case'}]","[{'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}]","[{'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}]",515.0,0.0238099,"Postoperative VAS pain scores at 0, 2, 4 and 6 h and the need for additional analgesics were significantly lower in group T than in group A. Postoperative VAS pain scores at 12 and 24 h were significantly higher in group T than in group A. Postoperative nausea and vomiting were significantly lower in group T than in group A.","[{'ForeName': 'Arzu Esen', 'Initials': 'AE', 'LastName': 'Tekeli', 'Affiliation': 'Department of Anaesthesiology and Reanimation, Van Yuzuncu Yil University School of Medicine, Van, Turkey.'}, {'ForeName': 'Esra', 'Initials': 'E', 'LastName': 'Eker', 'Affiliation': 'Department of Anaesthesiology and Reanimation, Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital, İstanbul, Turkey.'}, {'ForeName': 'Mehmet Kadir', 'Initials': 'MK', 'LastName': 'Bartin', 'Affiliation': 'Department of General Surgery, Health Sciences University Van Training and Research Hospital, Van, Turkey.'}, {'ForeName': 'Muzaffer Önder', 'Initials': 'MÖ', 'LastName': 'Öner', 'Affiliation': 'Department of General Surgery, Health Sciences University Van Training and Research Hospital, Van, Turkey.'}]",The Journal of international medical research,['10.1177/0300060520944058']
2440,32796502,Effects of a Physical Activity Program Potentiated with ICTs on the Formation and Dissolution of Friendship Networks of Children in a Middle-Income Country.,"This paper assesses the potential cohesion effect of a physical activity (PA) school-based intervention potentiated using text messages (SMS) through analyzing longitudinally the friendship network structure and the mechanisms of the formation and dissolution of friendships. Three schools ( n  = 125 participants) in Bogotá, Colombia, were randomly assigned into three groups: Modulo Activo Recreo Activo (MARA) + SMS (networks 1 and 2), MARA (networks 3 and 4), and control (no intervention: networks 5-7). We collected socio-economic, health-related, network structure, and intervention satisfaction variables in the baseline and after 10 weeks on July-November 2013. For each classroom network, we conducted four models using a temporal and static network approach to assess (1) temporal social network changes, (2) friendship homophily, (3) friendship formation and dissolution mechanisms, and (4) effect of SMS on the networks' cohesion. We found that (1) social cohesion emerged in the four intervened networks that were measured over time with transitivity and homophily driven by clustering, (2) the intervention affected the mechanisms of friendship formation and dissolution, and (3) MARA + SMS on average created more social cohesion and 3.8 more friendships than the program alone. Potentially, school-based interventions with information and communication technologies (ICT) such as MARA + SMS could encourage social cohesion among children. The particular characteristics of each school network need to be considered when developing school-based interventions.",2020,"We found that (1) social cohesion emerged in the four intervened networks that were measured over time with transitivity and homophily driven by clustering, (2) the intervention affected the mechanisms of friendship formation and dissolution, and (3) MARA + SMS on average created more social cohesion and 3.8 more friendships than the program alone.","['Children in a Middle-Income Country', 'Three schools ( n  = 125 participants) in Bogotá, Colombia', 'children']","['Modulo Activo Recreo Activo (MARA) + SMS (networks 1 and 2), MARA (networks 3 and 4), and control (no intervention: networks 5-7', 'physical activity (PA) school-based intervention potentiated using text messages (SMS', 'information and communication technologies (ICT) such as MARA + SMS', 'Physical Activity Program Potentiated with ICTs']",['Formation and Dissolution of Friendship Networks'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C3245499', 'cui_str': 'Colombia'}]","[{'cui': 'C0445579', 'cui_str': 'Recreo'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0324975', 'cui_str': 'Dolichotis patagonum'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0683867', 'cui_str': 'Information Technology'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0178647', 'cui_str': 'Friendship'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}]",,0.0241644,"We found that (1) social cohesion emerged in the four intervened networks that were measured over time with transitivity and homophily driven by clustering, (2) the intervention affected the mechanisms of friendship formation and dissolution, and (3) MARA + SMS on average created more social cohesion and 3.8 more friendships than the program alone.","[{'ForeName': 'Ana M', 'Initials': 'AM', 'LastName': 'Guerra', 'Affiliation': 'Department of Industrial Engineering, Universidad de Los Andes, Bogotá 111711, Colombia.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Montes', 'Affiliation': 'Department of Industrial Engineering, Universidad de Los Andes, Bogotá 111711, Colombia.'}, {'ForeName': 'Andrés F', 'Initials': 'AF', 'LastName': 'Useche', 'Affiliation': 'Department of Industrial Engineering, Universidad de Los Andes, Bogotá 111711, Colombia.'}, {'ForeName': 'Ana María', 'Initials': 'AM', 'LastName': 'Jaramillo', 'Affiliation': 'Department of Industrial Engineering, Universidad de Los Andes, Bogotá 111711, Colombia.'}, {'ForeName': 'Silvia A', 'Initials': 'SA', 'LastName': 'González', 'Affiliation': ""Healthy Active Living and Obesity Research Group, Children's Hospital of Eastern Ontario Research Institute, Ottawa, ON K1H 8L1, Canada.""}, {'ForeName': 'Jose D', 'Initials': 'JD', 'LastName': 'Meisel', 'Affiliation': 'Social and Health Complexity Center, Universidad de Los Andes, Bogotá 111711, Colombia.'}, {'ForeName': 'Catalina', 'Initials': 'C', 'LastName': 'Obando', 'Affiliation': 'INRIA, Institut du Cerveau et de la Moelle épinière, ICM, Inserm U 1127, CNRS UMR 7225, Sorbonne Université, 75013 Paris, France.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Cardozo', 'Affiliation': 'Department of Industrial Engineering, Universidad de Los Andes, Bogotá 111711, Colombia.'}, {'ForeName': 'Ruth F', 'Initials': 'RF', 'LastName': 'Hunter', 'Affiliation': ""Centre for Public Health, School of Medicine, Dentistry and Biomedical Sciences, Queen's University Belfast, Belfast BT7 1NN, UK.""}, {'ForeName': 'Olga L', 'Initials': 'OL', 'LastName': 'Sarmiento', 'Affiliation': 'School of Medicine, Universidad de los Andes, Bogotá 111711, Colombia.'}]",International journal of environmental research and public health,['10.3390/ijerph17165796']
2441,32803636,Influence of green tea consumption on endoxifen steady-state concentration in breast cancer patients treated with tamoxifen.,"BACKGROUND


Many cancer patients use additional herbs or supplements in combination with their anti-cancer therapy. Green tea-active ingredient epigallocatechin-3-gallate (EGCG)-is one of the most commonly used dietary supplements among breast cancer patients. EGCG may alter the metabolism of tamoxifen. Therefore, the aim of this study was to investigate the influence of green tea supplements on the pharmacokinetics of endoxifen; the most relevant active metabolite of tamoxifen.
METHODS


In this single-center, randomized cross-over trial, effects of green tea capsules on endoxifen levels were evaluated. Patients treated with tamoxifen for at least 3 months were eligible for this study. After inclusion, patients were consecutively treated with tamoxifen monotherapy for 28 days and in combination with green tea supplements (1 g twice daily; containing 300 mg EGCG) for 14 days (or vice versa). Blood samples were collected on the last day of monotherapy or combination therapy. Area under the curve (AUC 0-24h ), maximum concentration (C max ) and minimum concentration (C trough ) were obtained from individual plasma concentration-time curves.
RESULTS


No difference was found in geometric mean endoxifen AUC 0-24h  in the period with green tea versus tamoxifen monotherapy (- 0.4%; 95% CI - 8.6 to 8.5%; p = 0.92). Furthermore, no differences in C max  (- 2.8%; - 10.6 to 5.6%; p = 0.47) nor C trough  (1.2%; - 7.3 to 10.5%; p = 0.77) were found. Moreover, no severe toxicity was reported during the whole study period.
CONCLUSIONS


This study demonstrated the absence of a pharmacokinetic interaction between green tea supplements and tamoxifen. Therefore, the use of green tea by patients with tamoxifen does not have to be discouraged.",2020,No difference was found in geometric mean endoxifen AUC 0-24h  in the period with green tea versus tamoxifen monotherapy (- 0.4%; 95% CI - 8.6 to 8.5%; p = 0.92).,"['breast cancer patients treated with', 'breast cancer patients']","['tamoxifen monotherapy', 'EGCG', 'green tea consumption', 'additional herbs or supplements in combination with their anti-cancer therapy', 'green tea capsules', 'green tea supplements (1\xa0g twice daily; containing 300\xa0mg EGCG', 'green tea supplements', 'Green tea-active ingredient epigallocatechin-3-gallate (EGCG)-is', 'tamoxifen']","['metabolism of tamoxifen', 'Area under the curve (AUC 0-24h ), maximum concentration (C max ) and minimum concentration (C trough ', 'severe toxicity', 'endoxifen steady-state concentration', 'C max', 'geometric mean endoxifen AUC', 'endoxifen levels']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0039286', 'cui_str': 'Tamoxifen'}, {'cui': 'C0059438', 'cui_str': 'epigallocatechin gallate'}, {'cui': 'C1384640', 'cui_str': 'Green tea'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0019240', 'cui_str': 'Herb'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C1292749', 'cui_str': 'Has active ingredient'}]","[{'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0039286', 'cui_str': 'Tamoxifen'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0048311', 'cui_str': '4-hydroxy-N-desmethyltamoxifen'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.137654,No difference was found in geometric mean endoxifen AUC 0-24h  in the period with green tea versus tamoxifen monotherapy (- 0.4%; 95% CI - 8.6 to 8.5%; p = 0.92).,"[{'ForeName': 'C Louwrens', 'Initials': 'CL', 'LastName': 'Braal', 'Affiliation': 'Department of Medical Oncology, Erasmus MC Cancer Institute, Dr. Molewaterplein 40, CN, PO Box 2040, 3015, Rotterdam, The Netherlands. c.braal@erasmusmc.nl.'}, {'ForeName': 'Koen G A M', 'Initials': 'KGAM', 'LastName': 'Hussaarts', 'Affiliation': 'Department of Medical Oncology, Erasmus MC Cancer Institute, Dr. Molewaterplein 40, CN, PO Box 2040, 3015, Rotterdam, The Netherlands.'}, {'ForeName': 'Lieke', 'Initials': 'L', 'LastName': 'Seuren', 'Affiliation': 'Department of Medical Oncology, Erasmus MC Cancer Institute, Dr. Molewaterplein 40, CN, PO Box 2040, 3015, Rotterdam, The Netherlands.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Oomen-de Hoop', 'Affiliation': 'Department of Medical Oncology, Erasmus MC Cancer Institute, Dr. Molewaterplein 40, CN, PO Box 2040, 3015, Rotterdam, The Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'de Bruijn', 'Affiliation': 'Department of Medical Oncology, Erasmus MC Cancer Institute, Dr. Molewaterplein 40, CN, PO Box 2040, 3015, Rotterdam, The Netherlands.'}, {'ForeName': 'Stefan A J', 'Initials': 'SAJ', 'LastName': 'Buck', 'Affiliation': 'Department of Medical Oncology, Erasmus MC Cancer Institute, Dr. Molewaterplein 40, CN, PO Box 2040, 3015, Rotterdam, The Netherlands.'}, {'ForeName': 'Monique E M M', 'Initials': 'MEMM', 'LastName': 'Bos', 'Affiliation': 'Department of Medical Oncology, Erasmus MC Cancer Institute, Dr. Molewaterplein 40, CN, PO Box 2040, 3015, Rotterdam, The Netherlands.'}, {'ForeName': 'Martine F', 'Initials': 'MF', 'LastName': 'Thijs-Visser', 'Affiliation': 'Department of Medical Oncology, Ikazia Hospital, Rotterdam, The Netherlands.'}, {'ForeName': 'Hanneke J M', 'Initials': 'HJM', 'LastName': 'Zuetenhorst', 'Affiliation': 'Department of Internal Medicine, Franciscus Gasthuis & Vlietland, Schiedam, The Netherlands.'}, {'ForeName': 'Daniëlle', 'Initials': 'D', 'LastName': 'Mathijssen-van Stein', 'Affiliation': 'Department of Internal Medicine, Franciscus Gasthuis & Vlietland, Schiedam, The Netherlands.'}, {'ForeName': 'Mijntje B', 'Initials': 'MB', 'LastName': 'Vastbinder', 'Affiliation': 'Department of Internal Medicine, IJsselland Hospital, Capelle aan den IJssel, The Netherlands.'}, {'ForeName': 'Roelof W F', 'Initials': 'RWF', 'LastName': 'van Leeuwen', 'Affiliation': 'Department of Medical Oncology, Erasmus MC Cancer Institute, Dr. Molewaterplein 40, CN, PO Box 2040, 3015, Rotterdam, The Netherlands.'}, {'ForeName': 'Teun', 'Initials': 'T', 'LastName': 'van Gelder', 'Affiliation': 'Department of Clinical Pharmacy and Toxicology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Stijn L W', 'Initials': 'SLW', 'LastName': 'Koolen', 'Affiliation': 'Department of Medical Oncology, Erasmus MC Cancer Institute, Dr. Molewaterplein 40, CN, PO Box 2040, 3015, Rotterdam, The Netherlands.'}, {'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'Jager', 'Affiliation': 'Department of Medical Oncology, Erasmus MC Cancer Institute, Dr. Molewaterplein 40, CN, PO Box 2040, 3015, Rotterdam, The Netherlands.'}, {'ForeName': 'Ron H J', 'Initials': 'RHJ', 'LastName': 'Mathijssen', 'Affiliation': 'Department of Medical Oncology, Erasmus MC Cancer Institute, Dr. Molewaterplein 40, CN, PO Box 2040, 3015, Rotterdam, The Netherlands.'}]",Breast cancer research and treatment,['10.1007/s10549-020-05829-6']
2442,32805205,"Lubiprostone in patients with non-alcoholic fatty liver disease: a randomised, double-blind, placebo-controlled, phase 2a trial.","BACKGROUND


The laxative drug lubiprostone improves intestinal permeability in healthy volunteers. We aimed to assess efficacy and safety of lubiprostone in patients with non-alcoholic fatty liver disease (NAFLD) with constipation via attenuation of intestinal permeability.
METHODS


This randomised, double-blind, placebo-controlled, phase 2a study in Yokohama City University Hospital, Japan, recruited patients (aged 20-85 years) with NAFLD and constipation, alanine aminotransferase (ALT) at least 40 U/L, liver stiffness (≤6·7 kPa), and hepatic fat fraction at least 5·2% when assessed by MRI-proton density fat fraction. Eligible patients were randomly assigned (11:10:9) by a computer-based system and stratified by age and sex to receive 24 μg lubiprostone, 12 μg lubiprostone, or placebo, orally, once per day for 12 weeks. The primary endpoint was the absolute changes in ALT at 12 weeks. Efficacy analysis was done by intention to treat. Safety was assessed in all treated patients. This trial was registered with University Hospital Medical Information Network Clinical Trials Registry (UMIN000026635).
FINDINGS


Between March 24, 2017, and April 3, 2018, we screened 288 patients, of whom 150 (52%) were randomly assigned to treatment: 55 patients were assigned to receive 24 μg lubiprostone, 50 to receive 12 μg lubiprostone, and 45 to receive placebo. A greater decrease in the absolute ALT levels from baseline to 12 weeks was seen in the 24 μg lubiprostone group (mean -13 U/L [SD 19]) than in the placebo group (1 U/L [24]; mean difference -15 U/L [95% CI -23 to -6], p=0·0007) and in the 12 μg lubiprostone group (-12 U/L [21]) than in the placebo group (mean difference -13 U/L [-22 to -5], p=0·0023). 18 (33%) of 55 patients in the 24 μg group had at least one adverse event, as did three (6%) of 47 patients in the 12 μg group and three (7%) of 43 in the placebo group. The most common adverse event was diarrhoea (17 [31%] of patients in the 24 μg group, three [6%] in the 12 μg group, none in the placebo group). No life-threatening events or treatment-related deaths occurred.
INTERPRETATION


Lubiprostone was well tolerated and reduced the levels of liver enzymes in patients with NAFLD and constipation. Further studies are necessary to better define the efficacy and tolerability of lubiprostone in patients with NAFLD without constipation.
FUNDING


Mylan EPD G.K.",2020,"No life-threatening events or treatment-related deaths occurred.
","['288 patients, of whom 150 (52%) were randomly assigned to treatment: 55 patients', 'healthy volunteers', 'patients with NAFLD without constipation', 'Yokohama City University Hospital, Japan, recruited patients (aged 20-85 years) with NAFLD and constipation, alanine aminotransferase (ALT', 'patients with non-alcoholic fatty liver disease', 'patients with non-alcoholic fatty liver disease (NAFLD) with constipation via attenuation of intestinal permeability', 'Between March 24, 2017, and April 3, 2018', 'patients with NAFLD and constipation', 'Eligible patients']","['computer-based system and stratified by age and sex to receive 24 μg lubiprostone, 12 μg lubiprostone, or placebo', 'U/L', 'Lubiprostone', 'laxative drug lubiprostone', '24 μg lubiprostone, 50 to receive 12 μg lubiprostone, and 45 to receive placebo', 'lubiprostone', 'placebo']","['absolute ALT levels', 'Safety', 'intestinal permeability', 'diarrhoea', 'adverse event', 'efficacy and tolerability', 'efficacy and safety', 'absolute changes in ALT', 'levels of liver enzymes', 'liver stiffness (≤6·7 kPa), and hepatic fat fraction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C1684405', 'cui_str': 'lubiprostone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439339', 'cui_str': 'mU/mL'}, {'cui': 'C0282090', 'cui_str': 'Laxative'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0263428', 'cui_str': 'Ulerythema ophryogenes'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}]",55.0,0.708799,"No life-threatening events or treatment-related deaths occurred.
","[{'ForeName': 'Takaomi', 'Initials': 'T', 'LastName': 'Kessoku', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan; Department of Palliative Medicine, Yokohama City University Hospital, Yokohama, Japan.'}, {'ForeName': 'Kento', 'Initials': 'K', 'LastName': 'Imajo', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Ozaki', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Michihiro', 'Initials': 'M', 'LastName': 'Iwaki', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Honda', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan; Department of Palliative Medicine, Yokohama City University Hospital, Yokohama, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Kato', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan; Department of Gastroenterology, International University of Health and Welfare Atami Hospital, Atami, Japan.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Ogawa', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Wataru', 'Initials': 'W', 'LastName': 'Tomeno', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan; Department of Gastroenterology, International University of Health and Welfare Atami Hospital, Atami, Japan.'}, {'ForeName': 'Shingo', 'Initials': 'S', 'LastName': 'Kato', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Takuma', 'Initials': 'T', 'LastName': 'Higurashi', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Yoneda', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Kirikoshi', 'Affiliation': 'Clinical Laboratory Department, Yokohama City University Hospital, Yokohama, Japan.'}, {'ForeName': 'Kazumi', 'Initials': 'K', 'LastName': 'Kubota', 'Affiliation': 'Department of Biostatistics, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Masataka', 'Initials': 'M', 'LastName': 'Taguri', 'Affiliation': 'Department of Data Science, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Takeharu', 'Initials': 'T', 'LastName': 'Yamanaka', 'Affiliation': 'Department of Biostatistics, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Haruki', 'Initials': 'H', 'LastName': 'Usuda', 'Affiliation': 'Department of Pharmacology, Shimane University Faculty of Medicine, Izumo, Japan.'}, {'ForeName': 'Koichiro', 'Initials': 'K', 'LastName': 'Wada', 'Affiliation': 'Department of Pharmacology, Shimane University Faculty of Medicine, Izumo, Japan.'}, {'ForeName': 'Noritoshi', 'Initials': 'N', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan; Department of Oncology, Yokohama City University Hospital, Yokohama, Japan.'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Saito', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Nakajima', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan. Electronic address: nakajima-tky@umin.ac.jp.'}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(20)30216-8']
2443,32811701,Teaching preschool children correct toothbrushing habits through playful learning interventions: A randomized controlled trial.,"PURPOSE


This study aimed to investigate the effect of playful learning interventions (with toys, visual and auditory sources) on appropriate toothbrushing behaviors and the amount of accumulated plaque in preschool children.
DESIGN AND METHODS


The study was carried out as a parallel-group, randomized and controlled study during the period October-December 2018, with 100 preschool children. The preschool students were randomly assigned to an intervention and a control group. The children in the intervention group were given instructions on how to brush their teeth while the children in the control group were not given any instruction outside of what they had learned in preschool. The playful learning interventions that were carried out consisted of three rounds of meetings designed to educate the children about adopting appropriate toothbrushing behaviors.
RESULTS


The study groups were well matched at baseline (p = .537) and the intervention group showed statistically significant improvements in toothbrushing (p = .001) and plaque control (p = .001) following the intervention in comparison to the controls. Additionally, while the amount of plaque decreased in the children in the intervention group (p = .001), plaque increased in the control group after the intervention (p = .001).
CONCLUSIONS


This study showed that after the playful learning interventions carried out with the preschool children, appropriate toothbrushing behaviors were acquired and there was a decrease in the amount of plaque.
APPLICATION TO PRACTICE


Nurses who work with preschool children could use toys and songs as effective and entertaining nursing interventions for developing correct toothbrushing behaviors.",2020,The study groups were well matched at baseline (p = .537) and the intervention group showed statistically significant improvements in toothbrushing (p = .001) and plaque control (p = .001) following the intervention in comparison to the controls.,"['preschool students', 'Nurses who work with preschool children', 'Teaching preschool children correct toothbrushing habits through playful learning interventions', 'preschool children', 'period October-December 2018, with 100 preschool children']","['playful learning interventions', 'playful learning interventions (with toys, visual and auditory sources']","['plaque control', 'amount of plaque', 'plaque']","[{'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0183975', 'cui_str': 'Toothbrush'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040565', 'cui_str': 'Toy'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0449416', 'cui_str': 'Source'}]","[{'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",100.0,0.0398742,The study groups were well matched at baseline (p = .537) and the intervention group showed statistically significant improvements in toothbrushing (p = .001) and plaque control (p = .001) following the intervention in comparison to the controls.,"[{'ForeName': 'Deniz Done', 'Initials': 'DD', 'LastName': 'Akkaya', 'Affiliation': 'Department of Pediatric Nursing, Faculty of Health Sciences, Kutahya Health Sciences University, Kutahya, Turkey. Electronic address: denizdone.akkaya@ksbu.edu.tr.'}, {'ForeName': 'Emel', 'Initials': 'E', 'LastName': 'Sezici', 'Affiliation': 'Department of Pediatric Nursing, Faculty of Health Sciences, Kutahya Health Sciences University, Kutahya, Turkey. Electronic address: emel.sezici@ksbu.edu.tr.'}]",Journal of pediatric nursing,['10.1016/j.pedn.2020.08.001']
2444,32777055,"Cyclic alternating pattern (CAP) in children with obstructive sleep apnea and its relationship with adenotonsillectomy, behavior, cognition, and quality-of-life.","STUDY OBJECTIVES


To determine in children with obstructive sleep apnea (OSA) the effect of adenotonsillectomy on the cyclic alternating pattern (CAP) and the relationship between CAP and behavioral, cognitive, and quality-of-life measures.
METHODS


CAP parameters were analyzed in 365 overnight polysomnographic recordings of children with mild-to-moderate OSA enrolled in the Childhood Adenotonsillectomy Trial (CHAT), randomized to either early adenotonsillectomy (eAT) or watchful waiting with supportive care (WWSC). We also analyzed CAP in a subgroup of 72 children with moderate OSA (apnea-hypopnea index>10) that were part of the CHAT sample. Causal mediation analysis was performed to determine the independent effect of changes in CAP on selected outcome measures.
RESULTS


At baseline, a higher number of A1-phases per hour of sleep was significantly associated with worse behavioral functioning (caregiver BRIEF GCE: ρ=0.24, P=0.042; caregiver Conners' Rating Scale Global Index: ρ=0.25, P=0.036) and lower quality of life (OSA-18: ρ=0.27, P=0.022; PedsQL: ρ=-0.29, P=0.015) in the subgroup of children with moderate OSA, but not across the entire sample. At 7-months follow-up, changes in CAP parameters were comparable between the eAT and WWSC arms. CAP changes did not account for significant proportions of variations in behavioral, cognitive and quality-of-life performance measures at follow-up.
CONCLUSIONS


We show a significant association between the frequency of slow, high-amplitude waves with behavioral functioning as well as the quality-of-life in children with moderate OSA. Early adenotonsillectomy in children with mild-to-moderate OSA does not alter the microstructure of NREM sleep compared to watchful waiting after an approximately 7 month period of follow-up.
CLINICAL TRIAL


The study ""A Randomized Controlled Study of Adenotonsillectomy for Children With Obstructive Sleep Apnea Syndrome"" was registered at Clinicaltrials.gov (#NCT00560859).",2020,"CAP changes did not account for significant proportions of variations in behavioral, cognitive and quality-of-life performance measures at follow-up.
","['children with mild-to-moderate OSA', '72 children with moderate OSA (apnea-hypopnea index>10) that were part of the CHAT sample', '365 overnight polysomnographic recordings of children with mild-to-moderate OSA enrolled in the Childhood Adenotonsillectomy Trial (CHAT', 'children with obstructive sleep apnea', 'Children', 'children with moderate OSA', 'children with obstructive sleep apnea (OSA']","['Adenotonsillectomy', 'early adenotonsillectomy (eAT) or watchful waiting with supportive care (WWSC', 'adenotonsillectomy', 'Cyclic alternating pattern (CAP']","['CAP parameters', 'lower quality of life', 'quality-of-life', 'behavioral, cognitive and quality-of-life performance measures', 'CAP and behavioral, cognitive, and quality-of-life measures', 'higher number of A1-phases per hour of sleep', ""caregiver Conners' Rating Scale Global Index""]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0235546', 'cui_str': 'Slow shallow breathing'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0193959', 'cui_str': 'Tonsillectomy and adenoidectomy'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0439583', 'cui_str': 'Overnight'}, {'cui': 'C0680063', 'cui_str': 'Child of'}]","[{'cui': 'C0193959', 'cui_str': 'Tonsillectomy and adenoidectomy'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0344211', 'cui_str': 'Support'}, {'cui': 'C0439596', 'cui_str': 'Cyclic'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}]","[{'cui': 'C0439596', 'cui_str': 'Cyclic'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0564385', 'cui_str': '/hour'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",72.0,0.0678171,"CAP changes did not account for significant proportions of variations in behavioral, cognitive and quality-of-life performance measures at follow-up.
","[{'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Hartmann', 'Affiliation': 'The University of Adelaide, School of Electrical and Electronic Engineering, Adelaide, Australia.'}, {'ForeName': 'Oliviero', 'Initials': 'O', 'LastName': 'Bruni', 'Affiliation': 'Department of Social and Developmental Psychology, Sapienza University, Rome, Italy.'}, {'ForeName': 'Raffaele', 'Initials': 'R', 'LastName': 'Ferri', 'Affiliation': 'Sleep Research Center, Department of Neurology IC, Oasi Research Institute - IRCCS, Troina, Italy.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Redline', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital and Beth Israel Deaconess Medical School, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Baumert', 'Affiliation': 'The University of Adelaide, School of Electrical and Electronic Engineering, Adelaide, Australia.'}]",Sleep,['10.1093/sleep/zsaa145']
2445,32772684,Direct Transfer to Angio-Suite Versus Computed Tomography-Transit in Patients Receiving Mechanical Thrombectomy: A Randomized Trial.,"BACKGROUND AND PURPOSE


To quantify workflow metrics in patients receiving stroke imaging (noncontrast-enhanced computed tomography [CT] and CT-angiography) in either a computed-tomography scanner suite (CT-Transit [CTT]) or an angio-suite (direct transfer to angio-suite-[DTAS]-using flat-panel CT) before undergoing mechanical thrombectomy.
METHODS


Prospective, single-center investigator initiated randomized controlled trial in a comprehensive stroke center focusing on time from imaging to groin puncture (primary end point) and time from hospital admission to final angiographic result (secondary end point) in patients receiving mechanical thrombectomy for anterior circulation large vessel occlusion after randomization to the CTT or DTAS pathway.
RESULTS


The trial was stopped early after the enrollment of n=60 patients (CTT: n=34/60 [56.7 %]; DTAS: n=26/60 [43.3%]) of n=110 planned patients because of a preplanned interim analysis. Time from imaging to groin puncture was shorter in DTAS-patients (in minutes, median [interquartile range]: CTT: 26 [23-32]; DTAS: 19 [15-23];  P  value: 0.001). Time from hospital admission to stroke imaging was shorter in patients randomized to DTAS (CTT: 12 (7-18); DTAS: 21 (15-25),  P  value: 0.007). Time from hospital admission to final angiographic reperfusion was comparable between patient groups (CTT: 78 [58-92], DTAS: 80 [66-118];  P  value: 0.067).
CONCLUSIONS


This trial showed a reduction in time from imaging to groin-puncture when patients are transferred directly to the angiosuite for advanced stroke-imaging compared with imaging in a CT scanner suite. This time saving was outweighed by a longer admission to imaging time and could not translate into a shorter time to final angiographic reperfusion in this trial.",2020,Time from hospital admission to stroke imaging was shorter in patients randomized to DTAS,"['n=60 patients (CTT: n=34/60 [56.7 %]; DTAS', 'Patients Receiving Mechanical Thrombectomy', 'patients receiving mechanical thrombectomy for anterior circulation large vessel occlusion after randomization to the CTT or DTAS pathway', 'patients receiving']","['angio-suite (direct transfer to angio-suite-[DTAS]-using flat-panel CT', 'Direct Transfer to Angio-Suite Versus Computed Tomography-Transit', 'stroke imaging (noncontrast-enhanced computed tomography [CT] and CT-angiography', 'DTAS', 'computed-tomography scanner suite (CT-Transit [CTT']","['Time from imaging to groin puncture', 'Time from hospital admission to final angiographic reperfusion']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0162578', 'cui_str': 'Removal of thrombus'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0225990', 'cui_str': 'Large blood vessel structure'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0205324', 'cui_str': 'Flat'}, {'cui': 'C0441833', 'cui_str': 'Groups'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C1301827', 'cui_str': 'In transit'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C1536105', 'cui_str': 'CT angiography'}, {'cui': 'C0183115', 'cui_str': 'Scanner'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0018246', 'cui_str': 'Inguinal'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0035124', 'cui_str': 'Reperfusion'}]",,0.0900532,Time from hospital admission to stroke imaging was shorter in patients randomized to DTAS,"[{'ForeName': 'Johannes A R', 'Initials': 'JAR', 'LastName': 'Pfaff', 'Affiliation': 'Department of Neuroradiology (J.A.R.P., C.H., C.U., M.B., M.A.M.), Heidelberg University Hospital, Germany.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Schönenberger', 'Affiliation': 'Department of Neurology (S.S., S.N., P.A.R.), Heidelberg University Hospital, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Herweh', 'Affiliation': 'Department of Neuroradiology (J.A.R.P., C.H., C.U., M.B., M.A.M.), Heidelberg University Hospital, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Ulfert', 'Affiliation': 'Department of Neuroradiology (J.A.R.P., C.H., C.U., M.B., M.A.M.), Heidelberg University Hospital, Germany.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Nagel', 'Affiliation': 'Department of Neurology (S.S., S.N., P.A.R.), Heidelberg University Hospital, Germany.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Ringleb', 'Affiliation': 'Department of Neurology (S.S., S.N., P.A.R.), Heidelberg University Hospital, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Bendszus', 'Affiliation': 'Department of Neuroradiology (J.A.R.P., C.H., C.U., M.B., M.A.M.), Heidelberg University Hospital, Germany.'}, {'ForeName': 'Markus A', 'Initials': 'MA', 'LastName': 'Möhlenbruch', 'Affiliation': 'Department of Neuroradiology (J.A.R.P., C.H., C.U., M.B., M.A.M.), Heidelberg University Hospital, Germany.'}]",Stroke,['10.1161/STROKEAHA.120.029905']
2446,32782181,Text-only and picture conversation aids both supported shared decision making for breast cancer surgery: Analysis from a cluster randomized trial.,"OBJECTIVES


To determine if two encounter conversation aids for early-stage breast cancer surgery increased observed and patient-reported shared decision making (SDM) compared with usual care and if observed and patient-reported SDM were associated.
METHODS


Surgeons in a cluster randomized trial at four cancer centers were randomized to use an Option Grid, Picture Option Grid, or usual care. We used bivariate statistics, linear regression, and multilevel models to evaluate the influence of trial arm, patient socioeconomic status and health literacy on observed SDM (via OPTION-5) and patient-reported SDM (via collaboRATE).
RESULTS


From 311 recordings, OPTION-5 scores were 73/100 for Option Grid (n = 40), 56.3/100 for Picture Option Grid (n = 144), and 41.0/100 for usual care (n = 127; p < 0.0001). Top collaboRATE scores were 81.6 % for Option Grid, 80.0 % for Picture Option Grid, and 56.4 % for usual care (p < 0.001). Top collaboRATE scores correlated with an 8.60 point (95 %CI 0.66, 13.7) higher OPTION-5 score (p = 0.008) with no correlation in the multilevel analysis. Patients of lower socioeconomic status had lower OPTION-5 scores before accounting for clustering.
CONCLUSIONS


Both conversation aids led to meaningfully higher observed and patient-reported SDM. Observed and patient-reported SDM were not strongly correlated.
PRACTICE IMPLICATIONS


Healthcare providers could implement these conversation aids in real-world settings.",2020,"Top collaboRATE scores correlated with an 8.60 point (95 %CI 0.66, 13.7) higher OPTION-5 score (p = 0.008) with no correlation in the multilevel analysis.","['Surgeons in a cluster randomized trial at four cancer centers', 'breast cancer surgery']","['Option Grid, Picture Option Grid, or usual care', 'Text-only and picture conversation aids both supported shared decision making']",[],"[{'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C3179495', 'cui_str': 'Decision Making, Shared'}]",[],,0.13711,"Top collaboRATE scores correlated with an 8.60 point (95 %CI 0.66, 13.7) higher OPTION-5 score (p = 0.008) with no correlation in the multilevel analysis.","[{'ForeName': 'Renata W', 'Initials': 'RW', 'LastName': 'Yen', 'Affiliation': 'The Dartmouth Institute for Health Policy & Clinical Practice, Dartmouth College, Lebanon, NH, USA.'}, {'ForeName': 'Marie-Anne', 'Initials': 'MA', 'LastName': 'Durand', 'Affiliation': 'The Dartmouth Institute for Health Policy & Clinical Practice, Dartmouth College, Lebanon, NH, USA; Université Toulouse III Paul Sabatier, Toulouse, France.'}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Harris', 'Affiliation': 'The Dartmouth Institute for Health Policy & Clinical Practice, Dartmouth College, Lebanon, NH, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Cohen', 'Affiliation': 'Dartmouth College, Hanover, NH, USA.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Ward', 'Affiliation': 'Dartmouth College, Hanover, NH, USA.'}, {'ForeName': 'A James', 'Initials': 'AJ', 'LastName': ""O'Malley"", 'Affiliation': 'The Dartmouth Institute for Health Policy & Clinical Practice, Dartmouth College, Lebanon, NH, USA.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Schubbe', 'Affiliation': 'The Dartmouth Institute for Health Policy & Clinical Practice, Dartmouth College, Lebanon, NH, USA.'}, {'ForeName': 'Catherine H', 'Initials': 'CH', 'LastName': 'Saunders', 'Affiliation': 'The Dartmouth Institute for Health Policy & Clinical Practice, Dartmouth College, Lebanon, NH, USA; Centers for Health and Aging, Dartmouth-Hitchcock Medical Center, Lebanon, NH, USA.'}, {'ForeName': 'Glyn', 'Initials': 'G', 'LastName': 'Elwyn', 'Affiliation': 'The Dartmouth Institute for Health Policy & Clinical Practice, Dartmouth College, Lebanon, NH, USA. Electronic address: glynelwyn@gmail.com.'}]",Patient education and counseling,['10.1016/j.pec.2020.07.015']
2447,32784117,Idebenone does not inhibit disability progression in primary progressive MS.,"BACKGROUND


Multiple sclerosis (MS) is a chronic, immune-mediated neurodegenerative disorder of the central nervous system (CNS). While current MS therapies target the inflammatory processes, no treatment explicitly targets mitochondrial dysfunction and resulting axonal loss. Therefore, the aim of this study was to determine whether idebenone inhibits mitochondrial dysfunction and accumulation of disability in primary progressive MS (PPMS) and to enhance understanding of pathogenic mechanisms of PPMS progression using cerebrospinal fluid (CSF) biomarkers.
METHODS


The double-blind, placebo-controlled Phase I/II clinical trial of Idebenone in patients with Primary Progressive MS (IPPoMS; NCT00950248) was an adaptively designed, baseline-versus-treatment, placebo-controlled, CSF-biomarker-supported trial. Based on interim analysis of the 1-year pre-treatment data, change in the area under the curve of Combinatorial Weight-Adjusted Disability Score (CombiWISE) became the primary outcome, with >80% power to detect ≥40% efficacy with 28 patients/arm treated for 2 years in baseline versus treatment paradigm. Changes in traditional disability scales and in brain ventricular volume were secondary outcomes. Exploratory outcomes included CSF biomarkers of mitochondrial dysfunction (Growth/differentiation factor 15 [GDF15] and lactate), axonal damage (neurofilament light chain [NFL]), innate immunity (sCD14), blood brain barrier leakage (albumin quotient) and retinal nerve fiber layer thinning.
RESULTS


Idebenone was well tolerated but did not inhibit disability progression or CNS tissue destruction. Concentrations of GDF15, secreted predominantly by astrocytes and choroid plexus epithelium in vitro, increased after exposure to mitochondrial toxin rotenone, validating the ability of this biomarker to measure intrathecal mitochondrial damage. CSF GDF15 levels correlated strongly with age and MS patients had CSF levels of GDF15 significantly above age-adjusted healthy volunteers, with highest levels measured in PPMS. Idebenone did not change CSF GDF15 levels.
CONCLUSION


Mitochondrial dysfunction exceeding normal aging reflected by age-adjusted CSF GDF15 is present in the majority of PPMS patients, but it is not inhibited by idebenone.",2020,"CSF GDF15 levels correlated strongly with age and MS patients had CSF levels of GDF15 significantly above age-adjusted healthy volunteers, with highest levels measured in PPMS.","['patients with Primary Progressive MS (IPPoMS', 'primary progressive MS (PPMS']","['Idebenone', 'idebenone', 'placebo']","['Mitochondrial dysfunction', 'traditional disability scales', 'CSF levels of GDF15', 'CSF biomarkers of mitochondrial dysfunction (Growth/differentiation factor 15 [GDF15] and lactate), axonal damage (neurofilament light chain [NFL]), innate immunity (sCD14), blood brain barrier leakage (albumin quotient) and retinal nerve fiber layer thinning', 'CSF GDF15 levels', 'Combinatorial Weight-Adjusted Disability Score (CombiWISE', 'disability progression or CNS tissue destruction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0751964', 'cui_str': 'Primary progressive multiple sclerosis'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}]","[{'cui': 'C0123163', 'cui_str': 'idebenone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0026237', 'cui_str': 'Mitochondrion'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0007806', 'cui_str': 'Cerebrospinal fluid'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1431343', 'cui_str': 'GDF15 protein, human'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0027834', 'cui_str': 'Neurofilaments'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0020969', 'cui_str': 'Innate Immunity'}, {'cui': 'C0005854', 'cui_str': 'Brain-Blood Barrier'}, {'cui': 'C0015376', 'cui_str': 'Extravasation'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C1720466', 'cui_str': 'Nerve fiber layer'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C3540014', 'cui_str': 'CENTRAL NERVOUS SYSTEM'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C1261381', 'cui_str': 'Destructive procedure'}]",,0.0721347,"CSF GDF15 levels correlated strongly with age and MS patients had CSF levels of GDF15 significantly above age-adjusted healthy volunteers, with highest levels measured in PPMS.","[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Kosa', 'Affiliation': 'Neuroimmunological Diseases Section, Laboratory of Clinical Immunology and Microbiology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Tianxia', 'Initials': 'T', 'LastName': 'Wu', 'Affiliation': 'Clinical trials Unit, National Institute of Neurological Diseases and Stroke, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Phillips', 'Affiliation': 'Neuroimmunological Diseases Section, Laboratory of Clinical Immunology and Microbiology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Leinonen', 'Affiliation': 'Santhera Pharmaceuticals (Switzerland) AG, Pratteln Switzerland.'}, {'ForeName': 'Ruturaj', 'Initials': 'R', 'LastName': 'Masvekar', 'Affiliation': 'Neuroimmunological Diseases Section, Laboratory of Clinical Immunology and Microbiology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Komori', 'Affiliation': 'Neuroimmunological Diseases Section, Laboratory of Clinical Immunology and Microbiology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Wichman', 'Affiliation': 'Neuroimmunological Diseases Section, Laboratory of Clinical Immunology and Microbiology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Sandford', 'Affiliation': 'Neuroimmunological Diseases Section, Laboratory of Clinical Immunology and Microbiology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Bibiana', 'Initials': 'B', 'LastName': 'Bielekova', 'Affiliation': 'Neuroimmunological Diseases Section, Laboratory of Clinical Immunology and Microbiology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA. Electronic address: Bibi.Bielekova@nih.gov.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2020.102434']
2448,32794658,Application of three dimensional (3D) curved multi-planar reconstruction images in 3D printing mold assisted eyebrow arch keyhole microsurgery.,"OBJECTIVE


The application of multi-planar reconstruction of three dimensional (3D) curved surface in microsurgery of 3D printing mold assisted eyebrow arch keyhole approach was studied.
METHODS


Eighty patients with intracranial aneurysms who underwent treatment at our hospital were enrolled. The patients were divided into two groups: the traditional eyebrow keyhole approach microsurgery group (38 cases in the conventional treatment group) and the three-dimensional curved surface multi-plane reconstruction image combined with 3D printing technology assisted eyebrow keyhole approach microsurgery group (42 cases in the 3D printing assisted treatment group). The Hunt-Hess classification was used to make a preliminary estimation of the patient's condition. The 3D curved multi-planar reconstruction method was used to assist the surgical plan; CT scan was used to establish a 3D printing mold, and the patient's condition and surgical plan were accurately analyzed before surgery. The operative time and the size of the incision area were recorded; postoperative GOS score and postoperative complications were statistically investigated.
RESULTS


The 3D printing assisted treatment group (70.13 ± 15.56), (411.26 ± 10.38) mm 2  , the operative time and incision area were significantly shorter than the conventional treatment group (120.35 ± 20.46), (663.55 ± 13.54) mm 2  , p < .05); the GOS score showed that the 3D printing-assisted treatment group was significantly higher than the conventional treatment group (p < .05). The postoperative complication rate was significantly lower in the 3D print-assisted treatment group (9.52%) than in the conventional treatment group (47.36%, p < .05); the cure of intracranial aneurysms in the 3D printing assisted treatment group was more thorough than that in the conventional treatment group, and the difference was significant (p < .05).
CONCLUSION


Compared with the conventional eyebrow arch-hole approach microsurgery, the 3D surface multi-planar reconstruction image combined 3D printing assisted technology was safer and more effective, and the postoperative recovery was better and the incidence of complications was lower.",2020,"The postoperative complication rate was significantly lower in the 3D print-assisted treatment group (9.52%) than in the conventional treatment group (47.36%, p < .05); the cure of intracranial aneurysms in the 3D printing assisted treatment group was more thorough than that in the conventional treatment group, and the difference was significant (p < .05).
",['Eighty patients with intracranial aneurysms who underwent treatment at our hospital were enrolled'],"['three dimensional (3D) curved multi-planar reconstruction images', 'traditional eyebrow keyhole approach microsurgery group (38 cases in the conventional treatment group) and the three-dimensional curved surface multi-plane reconstruction image combined with 3D printing technology assisted eyebrow keyhole approach microsurgery group']","['operative time and incision area', 'postoperative complication rate', 'GOS score', 'operative time and the size of the incision area', 'postoperative GOS score and postoperative complications', 'cure of intracranial aneurysms']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007766', 'cui_str': 'Intracranial aneurysm'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0205133', 'cui_str': 'Bent'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0015420', 'cui_str': 'Eyebrow structure'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0026035', 'cui_str': 'Microsurgery'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0033161', 'cui_str': 'Printing'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}]","[{'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0007766', 'cui_str': 'Intracranial aneurysm'}]",80.0,0.0190235,"The postoperative complication rate was significantly lower in the 3D print-assisted treatment group (9.52%) than in the conventional treatment group (47.36%, p < .05); the cure of intracranial aneurysms in the 3D printing assisted treatment group was more thorough than that in the conventional treatment group, and the difference was significant (p < .05).
","[{'ForeName': 'Sheng-Jun', 'Initials': 'SJ', 'LastName': 'Li', 'Affiliation': 'Department of Neurosurgery, Linyi Central Hospital, Linyi, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': 'Department of Emergency, Linyi Central Hospital, Linyi, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'Department of Neurosurgery, Linyi Central Hospital, Linyi, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Su', 'Affiliation': 'Department of Neurosurgery, Linyi Central Hospital, Linyi, China.'}]",Brain and behavior,['10.1002/brb3.1785']
2449,32791950,Plaque Regression and Endothelial Progenitor Cell Mobilization With Intensive Lipid Elimination Regimen (PREMIER).,"BACKGROUND


Low-density lipoproteins (LDLs) are removed by extracorporeal filtration during LDL apheresis. It is mainly used in familial hyperlipidemia. The PREMIER trial (Plaque Regression and Progenitor Cell Mobilization With Intensive Lipid Elimination Regimen) evaluated LDL apheresis in nonfamilial hyperlipidemia acute coronary syndrome patients treated with percutaneous coronary intervention.
METHODS


We randomized 160 acute coronary syndrome patients at 4 Veterans Affairs centers within 72 hours of percutaneous coronary intervention to intensive lipid-lowering therapy (ILLT) comprising single LDL apheresis and statins versus standard medical therapy (SMT) with no LDL apheresis and statin therapy alone. Trial objectives constituted primary safety and primary efficacy end points and endothelial progenitor cell colony-forming unit mobilization in peripheral blood.
RESULTS


Mean LDL reduction at discharge was 53% in ILLT and 17% in SMT groups ( P <0.0001) from baseline levels of 116.3±34.3 and 110.7±32 mg/dL ( P =0.2979), respectively. The incidence of the primary safety end point of major peri-percutaneous coronary intervention adverse events was similar in both groups (ILLT, 3; SMT, 0). The primary efficacy end point, percentage change in total plaque volume at 90 days by intravascular ultrasound, on average decreased by 4.81% in the ILLT group and increased by 2.31% in the SMT group (difference of means, -7.13 [95% CI, -14.59 to 0.34];  P =0.0611). The raw change in total plaque volume on average decreased more in the ILLT group than in the SMT group (-6.01 versus -0.95 mm 3 ; difference of means, -5.06 [95% CI, -11.61 to 1.48];  P =0.1286). Similar results were obtained after adjusting for participating sites, age, preexisting coronary artery disease, diabetes mellitus, baseline LDL levels, and baseline plaque burden. There was robust endothelial progenitor cell colony-forming unit mobilization from baseline to 90 days in the ILLT group ( P =0.0015) but not in SMT ( P =0.0844).
CONCLUSIONS


PREMIER is the first randomized clinical trial to demonstrate safety and a trend for early coronary plaque regression with LDL apheresis in nonfamilial hyperlipidemia acute coronary syndrome patients treated with percutaneous coronary intervention. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01004406 and NCT02347098.",2020,"RESULTS


Mean LDL reduction at discharge was 53% in ILLT and 17% in SMT groups ( P <0.0001) from baseline levels of 116.3±34.3 and 110.7±32 mg/dL ( P =0.2979), respectively.","['nonfamilial hyperlipidemia acute coronary syndrome patients treated with percutaneous coronary intervention', '160 acute coronary syndrome patients at 4 Veterans Affairs centers within 72 hours of']","['percutaneous coronary intervention to intensive lipid-lowering therapy (ILLT) comprising single LDL apheresis and statins versus standard medical therapy (SMT) with no LDL apheresis and statin therapy alone', 'ILLT', 'SMT', 'Intensive Lipid Elimination Regimen (PREMIER', 'LDL apheresis', 'endothelial progenitor cell colony-forming unit mobilization']","['Mean LDL reduction at discharge', 'total plaque volume', 'major peri-percutaneous coronary intervention adverse events', 'Plaque Regression and Endothelial Progenitor Cell Mobilization', 'endothelial progenitor cell colony-forming unit mobilization']","[{'cui': 'C0020473', 'cui_str': 'Hyperlipidemia'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1292423', 'cui_str': '72 hours'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0585943', 'cui_str': 'Lipid-lowering therapy'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0949035', 'cui_str': 'Low density lipoprotein apheresis'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C3850017', 'cui_str': 'Circulating Endothelial Progenitor Cells'}, {'cui': 'C0439158', 'cui_str': 'colonies'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C3871203', 'cui_str': 'At discharge'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0684321', 'cui_str': 'Regression - mental defense mechanism'}, {'cui': 'C3850017', 'cui_str': 'Circulating Endothelial Progenitor Cells'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0439158', 'cui_str': 'colonies'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0439148', 'cui_str': 'Unit'}]",160.0,0.0519883,"RESULTS


Mean LDL reduction at discharge was 53% in ILLT and 17% in SMT groups ( P <0.0001) from baseline levels of 116.3±34.3 and 110.7±32 mg/dL ( P =0.2979), respectively.","[{'ForeName': 'Subhash', 'Initials': 'S', 'LastName': 'Banerjee', 'Affiliation': 'Veterans Affairs North Texas Health Care System, Dallas (S.B., J.L.H.).'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Luo', 'Affiliation': 'Cooperative Studies Program Coordinating Center, Edward Hines, Jr Veterans Affairs Hospital, Hines, IL (P.L., D.J.R., D.L., Y.W.).'}, {'ForeName': 'Domenic J', 'Initials': 'DJ', 'LastName': 'Reda', 'Affiliation': 'Cooperative Studies Program Coordinating Center, Edward Hines, Jr Veterans Affairs Hospital, Hines, IL (P.L., D.J.R., D.L., Y.W.).'}, {'ForeName': 'Faisal', 'Initials': 'F', 'LastName': 'Latif', 'Affiliation': 'Oklahoma City Veterans Affairs Medical Center (F.L.).'}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Hastings', 'Affiliation': 'Veterans Affairs North Texas Health Care System, Dallas (S.B., J.L.H.).'}, {'ForeName': 'Ehrin J', 'Initials': 'EJ', 'LastName': 'Armstrong', 'Affiliation': 'Rocky Mountain Regional Veterans Affairs Medical Center, Aurora, CO (E.J.A.).'}, {'ForeName': 'Jayant', 'Initials': 'J', 'LastName': 'Bagai', 'Affiliation': 'Veterans Affairs Tennessee Valley Health Care System, Nashville (J.B.).'}, {'ForeName': 'Mazen', 'Initials': 'M', 'LastName': 'Abu-Fadel', 'Affiliation': 'University of Oklahoma Health Sciences Center (F.L., M.A.-F.).'}, {'ForeName': 'Amutharani', 'Initials': 'A', 'LastName': 'Baskar', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas (S.B., J.L.H., A.B., P.K.).'}, {'ForeName': 'Preeti', 'Initials': 'P', 'LastName': 'Kamath', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas (S.B., J.L.H., A.B., P.K.).'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Lippe', 'Affiliation': 'Cooperative Studies Program Coordinating Center, Edward Hines, Jr Veterans Affairs Hospital, Hines, IL (P.L., D.J.R., D.L., Y.W.).'}, {'ForeName': 'Yongliang', 'Initials': 'Y', 'LastName': 'Wei', 'Affiliation': 'Cooperative Studies Program Coordinating Center, Edward Hines, Jr Veterans Affairs Hospital, Hines, IL (P.L., D.J.R., D.L., Y.W.).'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Scrymgeour', 'Affiliation': 'Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (A.S.).'}, {'ForeName': 'Theresa C', 'Initials': 'TC', 'LastName': 'Gleason', 'Affiliation': 'Department of Veterans Affairs, Office of Research and Development, Washington, DC (T.C.G.).'}, {'ForeName': 'Emmanouil S', 'Initials': 'ES', 'LastName': 'Brilakis', 'Affiliation': 'Minneapolis Heart Institute and Minneapolis Heart Institute Foundation, Abbott Northwestern Hospital, MN (E.S.B.).'}]",Circulation. Cardiovascular interventions,['10.1161/CIRCINTERVENTIONS.119.008933']
2450,32798568,Effect of exercise and grape juice on epigenetic modulation and functional outcomes in PD: A randomized clinical trial.,"OBJECTIVE


This study aimed to investigate the impact of an aquatic physical training program associated with grape juice (Vitis labrusca) consumption on functional outcomes, Brain-Derived Neurotrophic Factor (BDNF) and global histone H4 acetylation levels in peripheral blood from individuals with Parkinson's disease.
METHODS


Nineteen participants were randomized to Aquatic Exercise (AQ, n = 9) and Aquatic Exercise + Grape Juice (AQ+GJ, n = 10) groups and performed to 4 weeks of an aquatic intervention (twice a week, approximately 60 min/session). The AQ+GJ groups also consumed 400 mL of grape juice per day during this period. Functional capacity (six-min walk test, 6MWT), mobility (The Timed Up and Go, TUG) and the risk of falls (Berg Balance Scale, BBS) were evaluated before and after intervention. In addition, blood collections were carried out for biomarker analysis (e.g. BDNF and global histone H4).
RESULTS


The aquatic exercise program induced functional improvement in individuals with Parkinson's disease, specifically ameliorating their mobility and functional capacity. In addition, enhanced levels of BDNF and histone H4 acetylation were found after the intervention. Grape juice consumption did not potentiate these effects, since any significant differences between the AQ and AQ+GJ groups were not found in all analysed variables.
CONCLUSIONS


The present study provides important insights about aquatic exercise-modulated BDNF levels in individuals with Parkinson's disease in combination with functional improvements, suggesting that histone acetylation status may interact to dictate the molecular mechanisms involved in this response. Parkinson disease, aquatic exercise, BDNF, epigenetic, grape juice.",2020,"The aquatic exercise program induced functional improvement in individuals with Parkinson's disease, specifically ameliorating their mobility and functional capacity.","['PD', ""individuals with Parkinson's disease"", ""peripheral blood from individuals with Parkinson's disease"", 'Nineteen participants']","['exercise and grape juice', 'AQ+GJ', 'aquatic exercise program', 'aquatic exercise-modulated BDNF levels', 'Aquatic Exercise (AQ, n=9) and Aquatic Exercise\u202f+\u202fGrape Juice (AQ+GJ, n=10) groups and performed to 4 weeks of an aquatic intervention', 'aquatic physical training program associated with grape juice (Vitis labrusca) consumption']","['functional outcomes, Brain-Derived Neurotrophic Factor (BDNF) and global histone H4 acetylation levels', 'enhanced levels of BDNF and histone H4 acetylation', 'Functional capacity (six-min walk test, 6MWT), mobility (The Timed Up and Go, TUG) and the risk of falls (Berg Balance Scale, BBS', 'epigenetic modulation and functional outcomes']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0450337', 'cui_str': '19'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0452455', 'cui_str': 'Grape juice'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0949819', 'cui_str': 'Vitis'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0019648', 'cui_str': 'Histone H4'}, {'cui': 'C0001038', 'cui_str': 'Acetylation'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0398791', 'cui_str': 'Microcephaly, normal intelligence and immunodeficiency'}, {'cui': 'C1655731', 'cui_str': 'Epigenetic'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}]",19.0,0.0396303,"The aquatic exercise program induced functional improvement in individuals with Parkinson's disease, specifically ameliorating their mobility and functional capacity.","[{'ForeName': 'Grazielle Silva De', 'Initials': 'GS', 'LastName': 'Oliveira', 'Affiliation': 'Curso de Fisioterapia do Centro Universitário Metodista-IPA, Porto Alegre, RS-Brasil.'}, {'ForeName': 'Lucio', 'Initials': 'L', 'LastName': 'Iraci', 'Affiliation': 'Curso de Fisioterapia do Centro Universitário Metodista-IPA, Porto Alegre, RS-Brasil.'}, {'ForeName': 'Gislaine Siqueira', 'Initials': 'GS', 'LastName': 'Pinheiro', 'Affiliation': 'Curso de Fisioterapia do Centro Universitário Metodista-IPA, Porto Alegre, RS-Brasil.'}, {'ForeName': 'Marcela Zimmermann', 'Initials': 'MZ', 'LastName': 'Casal', 'Affiliation': 'Laboratório de Pesquisa do Exercício, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS-Brasil.'}, {'ForeName': 'Aline Nogueira', 'Initials': 'AN', 'LastName': 'Haas', 'Affiliation': 'Laboratório de Pesquisa do Exercício, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS-Brasil.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Pochmann', 'Affiliation': 'Programa de Pós-Graduação em Biociências e Reabilitação do Centro Universitário Metodista -IPA. Rua Coronel Joaquim Pedro Salgado, 80 - Rio Branco, Porto Alegre - RS, CEP 90420-060, Brasil.'}, {'ForeName': 'Flavia Gomes', 'Initials': 'FG', 'LastName': 'Martinez', 'Affiliation': 'Laboratório de Pesquisa do Exercício, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS-Brasil.'}, {'ForeName': 'Viviane', 'Initials': 'V', 'LastName': 'Elsner', 'Affiliation': 'Curso de Fisioterapia do Centro Universitário Metodista-IPA, Porto Alegre, RS-Brasil; Programa de Pós-Graduação em Biociências e Reabilitação do Centro Universitário Metodista -IPA. Rua Coronel Joaquim Pedro Salgado, 80 - Rio Branco, Porto Alegre - RS, CEP 90420-060, Brasil; Programa de Pós-Graduação em Ciências Biológicas: Fisiologia, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS-Brasil.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Dani', 'Affiliation': 'Programa de Pós-Graduação em Biociências e Reabilitação do Centro Universitário Metodista -IPA. Rua Coronel Joaquim Pedro Salgado, 80 - Rio Branco, Porto Alegre - RS, CEP 90420-060, Brasil. Electronic address: carolinedani@yahoo.com.br.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113135']
2451,32798570,Perceptual responses: Clinical versus practical blood flow restriction resistance exercise.,"The purpose of the current investigation was to compare the acute perceptual responses during low-load resistance exercise (RE) with clinical blood flow restriction (cBFR-RE) and practical blood flow restriction (pBFR-RE), and during conventional low- (LL-RE) and high-load resistance exercise (HL-RE), to determine if these responses differed between young males and females. Twenty-nine participants (14 males: 23.6±2.7years, 25.3±3.1kg/m 2  and 15 females: 20.3±1.6years, 23.4±1.9kg/m 2 ) completed the following exercise conditions in a randomized design: 1) cBFR-RE, 2) pBFR-RE, 3) HL-RE, and 4) LL-RE. Low-load conditions consisted of 30-15-15-15 repetitions of two-leg press (LP) and knee extension (KE) exercises with 30% one-repetition maximum (1-RM), and HL-RE consisted of 3 sets of 10 repetitions at 80% 1-RM, all with 60s rest intervals. Ratings of perceived exertion (RPE) and discomfort were assessed before exercise and immediately following each set. RPE was significantly higher in HL-RE compared to all low-load conditions for both exercises after each set (all p<0.05). cBFR-RE resulted in significantly greater RPE than pBFR-RE and LL-RE for both exercises for sets 1-4 for LP and sets 2-3 for KE (all p<0.05). Levels of discomfort were similar between cBFR-RE and HL-RE, which tended to be significantly higher than pBFR-RE and LL-RE (p<0.05). Men reported significantly greater RPE than women following sets 2-4 during KE with cBFR-RE and sets 2 and 3 during KE for HL-RE (all p<0.05). Males also reported significantly greater discomfort than women following sets 2-4 for KE LL-RE (p<0.05). Altogether, these data suggest that pBFR-RE may provide a more favorable BFR condition based on perceptual responses and that perceptual responses may differ between sexes across varying resistance exercise conditions.",2020,cBFR-RE resulted in significantly greater RPE than pBFR-RE and LL-RE for both exercises for sets 1-4 for LP and sets 2-3 for KE (all p<0.05).,"['Twenty-nine participants (14 males: 23.6±2.7years, 25.3±3.1kg/m 2  and 15 females: 20.3±1.6years, 23.4±1.9kg/m 2 ) completed the following exercise conditions in a randomized design', 'young males and females']","['low-load resistance exercise (RE) with clinical blood flow restriction (cBFR-RE) and practical blood flow restriction (pBFR-RE), and during conventional low- (LL-RE) and high-load resistance exercise (HL-RE', 'knee extension (KE) exercises with 30% one-repetition maximum (1-RM), and HL-RE']","['Levels of discomfort', 'Ratings of perceived exertion (RPE) and discomfort', 'acute perceptual responses', 'discomfort', 'RPE']","[{'cui': 'C0450351', 'cui_str': '29'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0042950', 'cui_str': 'Volition'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0035322', 'cui_str': 'Structure of retinal pigment epithelium'}]",,0.0352726,cBFR-RE resulted in significantly greater RPE than pBFR-RE and LL-RE for both exercises for sets 1-4 for LP and sets 2-3 for KE (all p<0.05).,"[{'ForeName': 'Ryan M', 'Initials': 'RM', 'LastName': 'Miller', 'Affiliation': 'Department of Health and Exercise Science, Neuromuscular Research Laboratory, University of Oklahoma, Norman, Oklahoma, USA. Electronic address: ryanmiller1@ou.edu.'}, {'ForeName': 'Bianca A R', 'Initials': 'BAR', 'LastName': 'Galletti', 'Affiliation': 'Department of Health and Exercise Science, Neuromuscular Research Laboratory, University of Oklahoma, Norman, Oklahoma, USA.'}, {'ForeName': 'Karolina J', 'Initials': 'KJ', 'LastName': 'Koziol', 'Affiliation': 'Department of Health and Exercise Science, Neuromuscular Research Laboratory, University of Oklahoma, Norman, Oklahoma, USA.'}, {'ForeName': 'Eduardo D S', 'Initials': 'EDS', 'LastName': 'Freitas', 'Affiliation': 'Department of Health and Exercise Science, Neuromuscular Research Laboratory, University of Oklahoma, Norman, Oklahoma, USA.'}, {'ForeName': 'Aaron D', 'Initials': 'AD', 'LastName': 'Heishman', 'Affiliation': 'Department of Health and Exercise Science, Neuromuscular Research Laboratory, University of Oklahoma, Norman, Oklahoma, USA; Department of Athletics, Basketball Strength and Performance, University of Oklahoma, Norman, Oklahoma, USA.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Black', 'Affiliation': 'Department of Health and Exercise Science, Sensory and Muscle Function Research Laboratory, University of Oklahoma, USA.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Larson', 'Affiliation': 'Departmeny of Health and Exercise Science, Sport, Health, and Exercise Data Analytics Laboratory, University of Oklahoma, Norman, Oklahoma, USA.'}, {'ForeName': 'Debra A', 'Initials': 'DA', 'LastName': 'Bemben', 'Affiliation': 'Departmeny of Health and Exercise Science, Bone Density Research Laboratory, University of Oklahoma, Norman, Oklahoma, USA.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Bemben', 'Affiliation': 'Department of Health and Exercise Science, Neuromuscular Research Laboratory, University of Oklahoma, Norman, Oklahoma, USA.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113137']
2452,32801130,Risk of Anemia With Metformin Use in Type 2 Diabetes: A MASTERMIND Study.,"OBJECTIVE


To evaluate the association between metformin use and anemia risk in type 2 diabetes, and the time-course for this, in a randomized controlled trial (RCT) and real-world population data.
RESEARCH DESIGN AND METHODS


Anemia was defined as a hemoglobin measure of <11 g/dL. In the RCTs A Diabetes Outcome Progression Trial (ADOPT;  n  = 3,967) and UK Prospective Diabetes Study (UKPDS;  n  = 1,473), logistic regression was used to model anemia risk and nonlinear mixed models for change in hematological parameters. In the observational Genetics of Diabetes Audit and Research in Tayside Scotland (GoDARTS) population ( n  = 3,485), discrete-time failure analysis was used to model the effect of cumulative metformin exposure on anemia risk.
RESULTS


In ADOPT, compared with sulfonylureas, the odds ratio (OR) (95% CI) for anemia was 1.93 (1.10, 3.38) for metformin and 4.18 (2.50, 7.00) for thiazolidinediones. In UKPDS, compared with diet, the OR (95% CI) was 3.40 (1.98, 5.83) for metformin, 0.96 (0.57, 1.62) for sulfonylureas, and 1.08 (0.62, 1.87) for insulin. In ADOPT, hemoglobin and hematocrit dropped after metformin initiation by 6 months, with no further decrease after 3 years. In UKPDS, hemoglobin fell by 3 years in the metformin group compared with other treatments. At years 6 and 9, hemoglobin was reduced in all treatment groups, with no greater difference seen in the metformin group. In GoDARTS, each 1 g/day of metformin use was associated with a 2% higher annual risk of anemia.
CONCLUSIONS


Metformin use is associated with early risk of anemia in individuals with type 2 diabetes, a finding consistent across two RCTs and replicated in one real-world study. The mechanism for this early fall in hemoglobin is uncertain, but given the time course, is unlikely to be due to vitamin B 12  deficiency alone.",2020,"At years 6 and 9, hemoglobin was reduced in all treatment groups, with no greater difference seen in the metformin group.","['Anemia was defined as a hemoglobin measure of <11 g/dL. In the A Diabetes Outcome Progression Trial (ADOPT;  n  = 3,967) and UK Prospective Diabetes Study (UKPDS;  n  = 1,473) RCTs', 'Type 2 Diabetes', 'individuals with type 2 diabetes']","['Metformin', 'metformin']","['annual risk of anemia', 'Risk of Anemia', 'hemoglobin', 'anemia', 'hemoglobin and hematocrit', 'odds ratio (OR', 'early risk of anemia']","[{'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439267', 'cui_str': 'g/dL'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C1279919', 'cui_str': 'Early'}]",,0.042343,"At years 6 and 9, hemoglobin was reduced in all treatment groups, with no greater difference seen in the metformin group.","[{'ForeName': 'Louise A', 'Initials': 'LA', 'LastName': 'Donnelly', 'Affiliation': 'Population Health & Genomics, School of Medicine, University of Dundee, Dundee, U.K.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Dennis', 'Affiliation': 'Institute of Biomedical & Clinical Science, University of Exeter Medical School, Royal Devon & Exeter Hospital, Exeter, U.K.'}, {'ForeName': 'Ruth L', 'Initials': 'RL', 'LastName': 'Coleman', 'Affiliation': 'Institute of Cardiovascular and Medicine Sciences, University of Glasgow, Glasgow, U.K.'}, {'ForeName': 'Naveed', 'Initials': 'N', 'LastName': 'Sattar', 'Affiliation': 'Diabetes Trials Unit, Radcliffe Department of Medicine, University of Oxford, Oxford, U.K.'}, {'ForeName': 'Andrew T', 'Initials': 'AT', 'LastName': 'Hattersley', 'Affiliation': 'Institute of Biomedical & Clinical Science, University of Exeter Medical School, Royal Devon & Exeter Hospital, Exeter, U.K.'}, {'ForeName': 'Rury R', 'Initials': 'RR', 'LastName': 'Holman', 'Affiliation': 'Institute of Cardiovascular and Medicine Sciences, University of Glasgow, Glasgow, U.K.'}, {'ForeName': 'Ewan R', 'Initials': 'ER', 'LastName': 'Pearson', 'Affiliation': 'Population Health & Genomics, School of Medicine, University of Dundee, Dundee, U.K. e.z.pearson@dundee.ac.uk.'}]",Diabetes care,['10.2337/dc20-1104']
2453,32804876,Comparing the Analgesic Effects of 4 Nonpharmacologic Interventions on Term Newborns Undergoing Heel Lance: A Randomized Controlled Trial.,"This randomized trial compared the analgesic effect of 4 nonpharmacologic interventions (breastfeeding, oral sucrose, nonnutritive sucking, and skin-to-skin contact) on term newborns between 24 and 48 hours of age who underwent a heel lance. The Neonatal Pain, Agitation, and Sedation Scale was used to evaluate pain. The newborns (N = 226) were assigned to one of 4 intervention groups (n = 176) or a control group without pain intervention (n = 50). The results indicate that all intervention groups showed decreased pain levels when compared with the control group (P < .01). The oral sucrose group experienced a superior analgesic effect when compared with the skin-to-skin contact group (P < .01), but no difference was observed when compared with the breastfeeding group (P > .05) or the nonnutritive sucking group (P > .05). All intervention groups showed a shortened crying time (P < .01) and reduced procedural duration (P < .01) compared with the control group. All of these interventions are clinically applicable and acceptable when caring for a newborn during a minor painful procedure.",2020,The results indicate that all intervention groups showed decreased pain levels when compared with the control group (P < .01).,"['Term Newborns Undergoing Heel Lance', 'newborns (N = 226', 'term newborns between 24 and 48 hours of age who underwent a heel lance']","['Nonpharmacologic Interventions', '4 nonpharmacologic interventions (breastfeeding, oral sucrose, nonnutritive sucking, and skin-to-skin contact', 'control group without pain intervention']","['Neonatal Pain, Agitation, and Sedation Scale', 'procedural duration', 'superior analgesic effect', 'shortened crying time', 'pain levels']","[{'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0018870', 'cui_str': 'Heel structure'}, {'cui': 'C0522666', 'cui_str': 'Lance'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}, {'cui': 'C1271035', 'cui_str': 'Provision of non-nutritive sucking'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C0441636', 'cui_str': 'Surgical shortening - action'}, {'cui': 'C0010399', 'cui_str': 'Crying'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}]",226.0,0.0326912,The results indicate that all intervention groups showed decreased pain levels when compared with the control group (P < .01).,"[{'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Chang', 'Affiliation': ""Maternity Department (Mss Chang and Filoteo) and Nursing Research and Evidence-Based Practice (Dr Nasr), Stanford Children's Health, Palo Alto, California; and Department of Pediatrics, Stanford School of Medicine, Stanford, California (Dr Nasr).""}, {'ForeName': 'Lourdes', 'Initials': 'L', 'LastName': 'Filoteo', 'Affiliation': ''}, {'ForeName': 'Annette S', 'Initials': 'AS', 'LastName': 'Nasr', 'Affiliation': ''}]",The Journal of perinatal & neonatal nursing,['10.1097/JPN.0000000000000495']
2454,32815077,The Effect of a General Healthy Lifestyle Intervention Delivered Around Pregnancy on Gestational Weight Gain and Infant Growth.,"OBJECTIVES


A life-course perspective emphasizes healthy behaviors before, during, and after pregnancy to support a multi-generational risk reduction in obesity for mothers and infants. Optimal timing, content, and dose of such interventions is not well defined.
METHODS


We conducted a nested cohort within a randomized trial to evaluate whether a healthy lifestyle intervention around pregnancy led to a ""spill-over effect,"" including a healthier rate (kg/week) of maternal gestational weight gain, and infant growth during the first year. Study enrollment began in 2012, follow-up data collection completed in 2018, and the data were analyzed in 2019. The intervention focused on healthy maternal diet and physical activity but not pregnancy weight or infant feeding. Outcome data were abstracted from electronic medical records.
RESULTS


Of the 165 women who became pregnant, 114 enrolled in the nested cohort. The average pre-pregnancy BMI was 29.6 (SD 5.1) kg/m 2 . Mixed effects models suggested clinically insignificant differences in both the rate of gestational weight gain (-0.02 kg/week; 95% CI -0.09, 0.06) and the rate of infant growth (difference at 1 year: -0.002 kg/cm; 95% CI -0.009, 0.005).
CONCLUSIONS FOR PRACTICE


A behavioral intervention that focused on overall maternal health delivered in the time around pregnancy did not result in a ""spill-over effect"" on healthy gestational weight gain or healthy infant growth during the first year of life.
TRIAL REGISTRATION


This study is registered at www.clinicaltrials.gov NCT01316653.",2020,"Mixed effects models suggested clinically insignificant differences in both the rate of gestational weight gain (-0.02 kg/week; 95% CI -0.09, 0.06) and the rate of infant growth (difference at 1 year: -0.002 kg/cm; 95% CI -0.009, 0.005).
","['165 women who became pregnant', 'Study enrollment began in 2012, follow-up data collection completed in 2018, and the data were analyzed in 2019', 'mothers and infants', '114 enrolled in the nested cohort']","['General Healthy Lifestyle Intervention Delivered Around Pregnancy', 'healthy lifestyle intervention', 'healthy maternal diet and physical activity but not pregnancy weight or infant feeding']","['rate of gestational weight gain', 'maternal gestational weight gain, and infant growth', 'healthy gestational weight gain or healthy infant growth', 'Gestational Weight Gain and Infant Growth', 'average pre-pregnancy BMI', 'rate of infant growth', 'overall maternal health']","[{'cui': 'C4319555', 'cui_str': '165'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0024921', 'cui_str': 'Maternal Health'}]",,0.301696,"Mixed effects models suggested clinically insignificant differences in both the rate of gestational weight gain (-0.02 kg/week; 95% CI -0.09, 0.06) and the rate of infant growth (difference at 1 year: -0.002 kg/cm; 95% CI -0.009, 0.005).
","[{'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Heerman', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center, 2146 Belcourt Ave, 2nd Floor, Nashville, TN, 37212, USA. Bill.Heerman@vumc.org.'}, {'ForeName': 'Lauren R', 'Initials': 'LR', 'LastName': 'Samuels', 'Affiliation': 'Department of Biostatistics, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Barr', 'Affiliation': 'Vanderbilt University Medical School, Nashville, TN, USA.'}, {'ForeName': 'Laura E', 'Initials': 'LE', 'LastName': 'Burgess', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center, 2146 Belcourt Ave, 2nd Floor, Nashville, TN, 37212, USA.'}, {'ForeName': 'Katherine E', 'Initials': 'KE', 'LastName': 'Hartmann', 'Affiliation': 'Department of Obstetrics and Gynecology, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Shari L', 'Initials': 'SL', 'LastName': 'Barkin', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center, 2146 Belcourt Ave, 2nd Floor, Nashville, TN, 37212, USA.'}]",Maternal and child health journal,['10.1007/s10995-020-02998-0']
2455,32818546,Consumers' reactions to nutrition and ingredient labelling for wine - A cross-country discrete choice experiment.,"The purpose of this study is to examine consumers' reactions to the introduction of nutrition and ingredient labelling for wine, a product that is so far still exempt from mandatory nutrition and ingredient labelling. It also analyses the effect of positive and negative information about the use of ingredients in wine on consumers' choice. Representative samples for wine consumers from three distinctly different countries representing old and new wine markets (Australia, n = 745; Germany, n = 716; Italy, n = 715) completed a discrete choice experiment (DCE) with graphically simulated wine back labels. For each country, respondents were randomly allocated to a reference group and two different treatment conditions where they received newspaper-like information (positive, negative) before making choices. Results for the reference condition show that consumers across all three countries have a significant positive utility for detailed nutrition information. Instead, ingredient information only receives a positive utility in Italy, whereas German and Australian respondents do not receive utility from ingredient labelling. When consumers in the treatment group are confronted with negative media information the attribute importance of ingredients significantly increases across all three countries, clean labelled products without ingredients are preferred, and a significantly higher share of consumers in Germany and Italy prefer not to buy any wine. The treatment effect of positive media information on consumers' wine choice is lower than that of negative information. The results of the study have implications for the pending new regulation of wine labelling and for communication strategies of the wine industry that should actively inform consumers about the necessity of ingredients in wine production.",2020,"When consumers in the treatment group are confronted with negative media information the attribute importance of ingredients significantly increases across all three countries, clean labelled products without ingredients are preferred, and a significantly higher share of consumers in Germany and Italy prefer not to buy any wine.","['Representative samples for wine consumers from three distinctly different countries representing old and new wine markets (Australia, n\u202f=\u202f745; Germany, n\u202f=\u202f716; Italy, n\u202f=\u202f715) completed a']",['discrete choice experiment (DCE) with graphically simulated wine back labels'],[],"[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0043188', 'cui_str': 'Wine'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C1318228', 'cui_str': 'Market'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0043188', 'cui_str': 'Wine'}]",[],745.0,0.025423,"When consumers in the treatment group are confronted with negative media information the attribute importance of ingredients significantly increases across all three countries, clean labelled products without ingredients are preferred, and a significantly higher share of consumers in Germany and Italy prefer not to buy any wine.","[{'ForeName': 'Evelyn', 'Initials': 'E', 'LastName': 'Pabst', 'Affiliation': 'Geisenheim University, Von-Lade-Str. 1, 65395, Geisenheim, Germany. Electronic address: Evelyn.Pabst@hs-gm.de.'}, {'ForeName': 'Armando Maria', 'Initials': 'AM', 'LastName': 'Corsi', 'Affiliation': 'Adelaide Business School, The University of Adelaide, SA, 5005, Australia. Electronic address: Armando.Corsi@adelaide.edu.au.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Vecchio', 'Affiliation': 'Department of Agricultural Sciences, University of Naples Federico II, Via Università, 100, 80055, Portici (Naples), Italy. Electronic address: riccardo.vecchio@unina.it.'}, {'ForeName': 'Azzurra', 'Initials': 'A', 'LastName': 'Annunziata', 'Affiliation': 'Department of Economic and Legal Studies, University of Naples ""Parthenope"", Via G. Parisi, 13, 80133, Naples, Italy. Electronic address: azzurra.annunziata@uniparthenope.it.'}, {'ForeName': 'Simone Mueller', 'Initials': 'SM', 'LastName': 'Loose', 'Affiliation': 'Geisenheim University, Von-Lade-Str. 1, 65395, Geisenheim, Germany; Ehrenberg-Bass Instiute for Marketing Science, University of South, North Terrace, Adelaide, SA, 5000, Australia. Electronic address: Simone.Loose@hs-gm.de.'}]",Appetite,['10.1016/j.appet.2020.104843']
2456,32818573,"Clinical evaluation of the pharmacological impact of ashwagandha root extract on sleep in healthy volunteers and insomnia patients: A double-blind, randomized, parallel-group, placebo-controlled study.","ETHNOPHARMACOLOGICAL RELEVANCE


Ashwagandha (Withania somnifera (L.) Dunal.) is long known for its sleep-inducing effects. Ashwagandha can be proposed as an alternative to the recommended present treatments for insomnia. This study aimed to evaluate the pharmacological effect of Ashwagandha root extract on sleep in healthy subjects and also in the subjects having insomnia.
MATERIAL AND METHODS


We performed a randomized, parallel-group, stratified design, placebo-controlled study. A total of 80 eligible participants, 40 in Arm-A (healthy) and 40 in Arm-B (insomnia) were assigned to two groups, either Ashwagandha or placebo and studied for 8-weeks. The assessment was done based on the sleep parameters (Sleep Onset Latency, Total Sleep Time, Wake After Sleep Onset, Total time in bed, and Sleep Efficiency), Pittsburgh Sleep Quality Index and Hamilton Anxiety scale-A questionnaire, mental alertness on rising assessment, and sleep quality questionnaire. Safety and adverse events along with the concomitant medication were also assessed.
RESULTS


In both healthy and insomnia subjects, there was a significant improvement in the sleep parameters in the Ashwagandha root extract supplemented group. The improvement was found more significant in insomnia subjects than healthy subjects. Repeat measure Analysis of variance (ANOVA) confirmed the significant improvement in SOL (p 0.013), HAM-A outcomes (p < 0.05), mental alertness (p 0.01), and sleep quality (p < 0.05) of the insomnia patients. A two-way ANOVA was used to confirm the outcomes that denoted sleep onset latency (p < 0.0001) and sleep efficiency (p < 0.0001) as the most improved parameters, followed by TST (p < 0.002) and WASO(p < 0.040). All these parameters (SOL, TST, WASO, TIB, SE, PSQI, HAM-A, Mental Alertness, and Sleep quality) were also statistically assessed for the significant improvement within the group both for the treatment, and the placebo groups in the healthy and the insomnia datasets. Obtained results suggest statistically significant (p < 0.0001) changes between the baseline values and the end of the study results except for the HAM-A and the mental alertness scoresn the healthy subject group.
CONCLUSION


The present study confirms that Ashwagandha root extract can improve sleep quality and can help in managing insomnia. Ashwagandha root extract was well tolerated by all the participants irrespective of their health condition and age. Additional clinical trials are required to generalize the outcome.",2020,"HAM-A outcomes (p < 0.05), mental alertness (p 0.01), and sleep quality (p < 0.05) of the insomnia patients.","['80 eligible participants, 40 in Arm-A (healthy) and 40 in Arm-B (insomnia', 'healthy subjects and also in the subjects having insomnia', 'healthy volunteers and insomnia patients']","['Ashwagandha root extract', 'ashwagandha root extract', 'Ashwagandha or placebo', 'placebo']","['parameters (SOL, TST, WASO, TIB, SE, PSQI, HAM-A, Mental Alertness, and Sleep quality', 'sleep parameters', 'insomnia subjects', 'mental alertness', 'sleep parameters (Sleep Onset Latency, Total Sleep Time, Wake', 'sleep efficiency', 'Safety and adverse events', 'sleep quality', 'SOL', 'Total time in bed, and Sleep Efficiency), Pittsburgh Sleep Quality Index and Hamilton Anxiety scale-A questionnaire, mental alertness on rising assessment, and sleep quality questionnaire']","[{'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0613707', 'cui_str': 'Ashwagandha'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205208', 'cui_str': 'Solid'}, {'cui': 'C0041290', 'cui_str': 'Delayed hypersensitivity skin test for tuberculin PPD'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0030481', 'cui_str': 'Human T-cell lymphotropic virus 1-associated myelopathy'}, {'cui': 'C0549164', 'cui_str': 'Mental alertness'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",80.0,0.0352543,"HAM-A outcomes (p < 0.05), mental alertness (p 0.01), and sleep quality (p < 0.05) of the insomnia patients.","[{'ForeName': 'Deepak', 'Initials': 'D', 'LastName': 'Langade', 'Affiliation': 'D Y Patil University School of Medicine, Navi Mumbai, 400706, Maharashtra, India. Electronic address: deepak.langade@dypatil.edu.'}, {'ForeName': 'Vaishali', 'Initials': 'V', 'LastName': 'Thakare', 'Affiliation': 'D Y Patil University School of Medicine, Navi Mumbai, 400706, Maharashtra, India. Electronic address: vaishali.thakare@dypatil.edu.'}, {'ForeName': 'Subodh', 'Initials': 'S', 'LastName': 'Kanchi', 'Affiliation': 'NAMO Medical Education and Research Institute, Silvassa, DNH&DD, India. Electronic address: rksubodh@gmail.com.'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Kelgane', 'Affiliation': 'Maharashtra Emergency Medical Services, Defence Area, Pimple Gurav, Pimpri-Chinchwad, 411027, Maharashtra, India. Electronic address: sunildrkelgane@gmail.com.'}]",Journal of ethnopharmacology,['10.1016/j.jep.2020.113276']
2457,32825324,High-Dose Vitamin D Supplementation Improves Microcirculation and Reduces Inflammation in Diabetic Neuropathy Patients.,"We assessed the effect of different doses of vitamin D supplementation on microcirculation, signs and symptoms of peripheral neuropathy and inflammatory markers in patients with type 2 diabetes (T2DM). Sixty-seven patients with T2DM and peripheral neuropathy (34 females) were randomized into two treatment groups: Cholecalciferol 5000 IU and 40,000 IU once/week orally for 24 weeks. Severity of neuropathy (NSS, NDS scores, visual analogue scale), cutaneous microcirculation (MC) parameters and inflammatory markers (ILs, CRP, TNFα) were assessed before and after treatment. Vitamin D deficiency/insufficiency was detected in 78% of the 62 completed subjects. Following treatment with cholecalciferol 40,000 IU/week, a significant decrease in neuropathy severity (NSS,  p  = 0.001; NDS,  p  = 0.001; VAS,  p  = 0.001) and improvement of cutaneous MC were observed ( p  < 0.05). Also, we found a decrease in IL-6 level (2.5 pg/mL vs. 0.6 pg/mL,  p  < 0.001) and an increase in IL-10 level (2.5 pg/mL vs. 4.5 pg/mL,  p  < 0.001) after 24 weeks of vitamin D supplementation in this group. No changes were detected in the cholecalciferol 5000 IU/week group. High-dose cholecalciferol supplementation of 40,000 IU/week for 24 weeks was associated with improvement in clinical manifestation, cutaneous microcirculation and inflammatory markers in patients with T2DM and peripheral neuropathy.",2020,"Severity of neuropathy (NSS, NDS scores, visual analogue scale), cutaneous microcirculation (MC) parameters and inflammatory markers (ILs, CRP, TNFα) were assessed before and after treatment.","['78% of the 62 completed subjects', 'Diabetic Neuropathy Patients', 'Sixty-seven patients with T2DM and peripheral neuropathy (34 females', 'patients with type 2 diabetes (T2DM', 'patients with T2DM and peripheral neuropathy']","['High-Dose Vitamin D Supplementation', 'Cholecalciferol 5000 IU', 'vitamin D supplementation', 'cholecalciferol']","['microcirculation, signs and symptoms of peripheral neuropathy and inflammatory markers', 'Vitamin D deficiency/insufficiency', 'clinical manifestation, cutaneous microcirculation and inflammatory markers', 'neuropathy severity', 'Severity of neuropathy (NSS, NDS scores, visual analogue scale), cutaneous microcirculation (MC) parameters and inflammatory markers (ILs, CRP, TNFα', 'improvement of cutaneous MC', 'IL-10 level', 'IL-6 level']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0011882', 'cui_str': 'Diabetic neuropathy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517852', 'cui_str': '67'}, {'cui': 'C1869037', 'cui_str': 'Peripheral neuropathy (SMQ)'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C4319610', 'cui_str': '5000'}]","[{'cui': 'C0025962', 'cui_str': 'Microcirculation'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C1869037', 'cui_str': 'Peripheral neuropathy (SMQ)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D deficiency'}, {'cui': 'C0231179', 'cui_str': 'Insufficiency'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205319', 'cui_str': 'Manifest'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0194086', 'cui_str': 'Partial nephrectomy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}]",67.0,0.160226,"Severity of neuropathy (NSS, NDS scores, visual analogue scale), cutaneous microcirculation (MC) parameters and inflammatory markers (ILs, CRP, TNFα) were assessed before and after treatment.","[{'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Karonova', 'Affiliation': 'Almazov National Medical Research Centre, Institute of Endocrinology, 2 Akkuratova str., 197341 St. Petersburg, Russia.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Stepanova', 'Affiliation': 'Internal Medicine Department, Pavlov First Saint Petersburg State Medical University, 6-8 L.Tolstoy str., 197022 St. Petersburg, Russia.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Bystrova', 'Affiliation': 'Almazov National Medical Research Centre, Institute of Endocrinology, 2 Akkuratova str., 197341 St. Petersburg, Russia.'}, {'ForeName': 'Edward B', 'Initials': 'EB', 'LastName': 'Jude', 'Affiliation': 'Tameside Hospital NHS Foundation Trust, Ashton Under Lyne OL69RW, UK.'}]",Nutrients,['10.3390/nu12092518']
2458,32824190,The Smartphone-Assisted Intervention Improved Perception of Nutritional Status among Middle School Students.,"Misperception of nutritional status is common and hinders the progress of childhood obesity prevention. This study aimed to examine the effectiveness of a smartphone-assisted intervention to improve student and parental perception of students' nutritional status (underweight, normal weight, overweight, obese). We conducted a parallel-group controlled trial with a non-randomized design in three junior middle schools of Beijing, China in 2019. One school was allocated to the intervention group and two schools to the control group. A total of 573 students (aged 13.1 ± 0.4 years) participated in the trial. The 3-month intervention included three components: health education sessions for students and parents, regular monitoring of students' weight, and the provision of feedback via a smartphone application. Schools in the control group continued their usual practice. Primary outcomes included the student and parental accurate perception of students' nutritional status. The percentage of students' accurate perception of their own nutritional status in the intervention group increased from 49.0% to 59.2% from baseline to three months, whereas it decreased from 64.1% to 58.1% in the control group; the adjusted odds ratio (OR) between the two groups was 1.71 (95% confidence interval (CI): 1.13, 2.59). The intervention did not significantly improve parental perception of students' nutritional status ( p  > 0.05). The study findings provided a brief approach for improving perception of nutritional status among middle school students.",2020,The intervention did not significantly improve parental perception of students' nutritional status ( p  > 0.05).,"['Middle School Students', 'middle school students', 'three junior middle schools of Beijing, China in 2019', 'A total of 573 students (aged 13.1 ± 0.4 years) participated in the trial', ""students' nutritional status (underweight, normal weight, overweight, obese""]","['Smartphone-Assisted Intervention', 'smartphone-assisted intervention', ""health education sessions for students and parents, regular monitoring of students' weight, and the provision of feedback via a smartphone application""]","[""student and parental accurate perception of students' nutritional status"", ""parental perception of students' nutritional status"", ""percentage of students' accurate perception of their own nutritional status""]","[{'cui': 'C0557797', 'cui_str': 'Middle school'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C4042832', 'cui_str': 'Peking'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4708164', 'cui_str': '573'}, {'cui': 'C4517457', 'cui_str': '0.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0041667', 'cui_str': 'Underweight'}, {'cui': 'C2712185', 'cui_str': 'Normal weight'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0439165', 'cui_str': 'Percent'}]",3.0,0.0150395,The intervention did not significantly improve parental perception of students' nutritional status ( p  > 0.05).,"[{'ForeName': 'Yan-Hui', 'Initials': 'YH', 'LastName': 'Shen', 'Affiliation': 'Department of School Health, Beijing Haidian District Center for Diseases Prevention and Control, Beijing 100095, China.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Department of Maternal and Child Health, School of Public Health, Peking University, Beijing 100191, China.'}, {'ForeName': 'Wen-Hao', 'Initials': 'WH', 'LastName': 'Li', 'Affiliation': 'Department of Maternal and Child Health, School of Public Health, Peking University, Beijing 100191, China.'}, {'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Zhou', 'Affiliation': 'Department of Maternal and Child Health, School of Public Health, Peking University, Beijing 100191, China.'}, {'ForeName': 'Jin-Hui', 'Initials': 'JH', 'LastName': 'Xu', 'Affiliation': 'Department of Maternal and Child Health, School of Public Health, Peking University, Beijing 100191, China.'}, {'ForeName': 'Chu', 'Initials': 'C', 'LastName': 'Jiang', 'Affiliation': 'Department of School Health, Beijing Haidian District Center for Diseases Prevention and Control, Beijing 100095, China.'}, {'ForeName': 'Hai-Jun', 'Initials': 'HJ', 'LastName': 'Wang', 'Affiliation': 'Department of Maternal and Child Health, School of Public Health, Peking University, Beijing 100191, China.'}]",International journal of environmental research and public health,['10.3390/ijerph17165932']
2459,32827458,Implementation of Multifaceted Patient-Centered Treatment Strategies for Intensive Blood Pressure Control (IMPACTS): Rationale and design of a cluster-randomized trial.,"BACKGROUND


The Systolic Blood Pressure Intervention Trial (SPRINT) reported that intensive blood pressure (BP) treatment reduced cardiovascular disease and mortality compared to standard BP treatment in hypertension patients. The next important question is how to implement more intensive BP treatment in real-world clinical practice. We designed an effectiveness-implementation hybrid trial to simultaneously test the effectiveness of a multifaceted intervention for intensive BP treatment and its feasibility, fidelity, and sustainability in underserved hypertension patients.
METHODS


Implementation of Multifaceted Patient-Centered Treatment Strategies for Intensive Blood Pressure Control (IMPACTS) is a cluster randomized trial conducted in 36 Federally Qualified Health Center clinics in Louisiana and Mississippi. Federally Qualified Health Center clinics were randomized to either a multifaceted intervention for intensive BP treatment, including protocol-based treatment using the SPRINT intensive BP management algorithm, dissemination of SPRINT findings, BP audit and feedback, home BP monitoring, and health coaching, or enhanced usual care. Difference in mean systolic BP change from baseline to 18 months is the primary clinical effectiveness outcome, and intervention fidelity, measured by treatment intensification and medication adherence, is the primary implementation outcome. The planned sample size of 1,260 participants (36 clinics with 35 participants each) has 90% power to detect a 5.0-mm Hg difference in systolic BP at a .05 significance level and 80% follow-up rate.
CONCLUSIONS


IMPACTS will generate critical data on the effectiveness and implementation of a multifaceted intervention for intensive BP treatment in real-world clinical practice and could directly impact the BP-related disease burden in minority and low-income populations in the United States.",2020,"FQHC clinics were randomized to either a multifaceted intervention for intensive BP treatment, including protocol-based treatment using the SPRINT intensive BP management algorithm, dissemination of SPRINT findings, BP audit and feedback, home BP monitoring, and health coaching, or enhanced usual care.","['hypertension patients', '36 Federally Qualified Health Center (FQHC) clinics in Louisiana and Mississippi', 'FQHC clinics', 'underserved hypertension patients', '1,260 participants (36 clinics with 35 participants each']","['Multifaceted Patient-Centered Treatment Strategies for Intensive Blood Pressure Control (IMPACTS', 'multifaceted intervention', 'multifaceted intervention for intensive BP treatment, including protocol-based treatment using the SPRINT intensive BP management algorithm, dissemination of SPRINT findings, BP audit and feedback, home BP monitoring, and health coaching, or enhanced usual care', 'intensive blood pressure (BP']","['feasibility, fidelity, and sustainability', 'systolic BP', 'mean systolic BP change', 'cardiovascular disease and mortality']","[{'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0024024', 'cui_str': 'Louisiana'}, {'cui': 'C0026221', 'cui_str': 'Mississippi'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1272452', 'cui_str': 'Blood pressure taking management'}, {'cui': 'C0205221', 'cui_str': 'Disseminated'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C1449681', 'cui_str': 'Home Blood Pressure Monitoring'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",1260.0,0.0928859,"FQHC clinics were randomized to either a multifaceted intervention for intensive BP treatment, including protocol-based treatment using the SPRINT intensive BP management algorithm, dissemination of SPRINT findings, BP audit and feedback, home BP monitoring, and health coaching, or enhanced usual care.","[{'ForeName': 'Katherine T', 'Initials': 'KT', 'LastName': 'Mills', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, LA; Tulane University Translational Sciences Institute, New Orleans, LA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Peacock', 'Affiliation': 'Department of Medicine, Tulane University School of Medicine, New Orleans, LA.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, LA; Department of Medicine, Tulane University School of Medicine, New Orleans, LA; Tulane University Translational Sciences Institute, New Orleans, LA.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Zimmerman', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, LA.'}, {'ForeName': 'Kenya', 'Initials': 'K', 'LastName': 'Brooks', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, LA.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'He', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, LA; Tulane University Translational Sciences Institute, New Orleans, LA.'}, {'ForeName': 'Alecia', 'Initials': 'A', 'LastName': 'Cyprian', 'Affiliation': 'Southeast Community Health Systems, Greensburg, LA.'}, {'ForeName': 'Gerrelda', 'Initials': 'G', 'LastName': 'Davis', 'Affiliation': 'Louisiana Primary Care Association, Baton Rouge, LA.'}, {'ForeName': 'Sonja R', 'Initials': 'SR', 'LastName': 'Fuqua', 'Affiliation': 'Community Health Center Association of Mississippi, Jackson, MS.'}, {'ForeName': 'Angelique', 'Initials': 'A', 'LastName': 'Greer', 'Affiliation': 'Coastal Family Health Center, Biloxi, MS.'}, {'ForeName': 'Lea', 'Initials': 'L', 'LastName': 'Gray-Winfrey', 'Affiliation': 'EXCELth, Inc., New Orleans, LA.'}, {'ForeName': 'Shondra', 'Initials': 'S', 'LastName': 'Williams', 'Affiliation': 'InclusivCare, Avondale, LA.'}, {'ForeName': 'Gary M', 'Initials': 'GM', 'LastName': 'Wiltz', 'Affiliation': 'Teche Action Board, Inc., Franklin, LA.'}, {'ForeName': 'Keith L', 'Initials': 'KL', 'LastName': 'Winfrey', 'Affiliation': 'NOELA Community Health Center, New Orleans, LA.'}, {'ForeName': 'Paul K', 'Initials': 'PK', 'LastName': 'Whelton', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, LA; Department of Medicine, Tulane University School of Medicine, New Orleans, LA; Tulane University Translational Sciences Institute, New Orleans, LA.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Krousel-Wood', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, LA; Department of Medicine, Tulane University School of Medicine, New Orleans, LA; Tulane University Translational Sciences Institute, New Orleans, LA.'}, {'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, LA; Department of Medicine, Tulane University School of Medicine, New Orleans, LA; Tulane University Translational Sciences Institute, New Orleans, LA. Electronic address: jhe@tulane.edu.'}]",American heart journal,['10.1016/j.ahj.2020.08.009']
2460,32827517,"Ropinirole, a dopamine agonist with high D 3  affinity, reduces proactive inhibition: A double-blind, placebo-controlled study in healthy adults.","Response inhibition describes the cognitive processes mediating the suppression of unwanted actions. A network involving the basal ganglia mediates two forms of response inhibition: reactive and proactive inhibition. Reactive inhibition serves to abruptly stop motor activity, whereas proactive inhibition is goal-orientated and results in slowing of motor activity in anticipation of stopping. Due to its impairment in several psychiatric disorders, the neurochemistry of response inhibition has become of recent interest. Dopamine has been posed as a candidate mediator of response inhibition due to its role in functioning of the basal ganglia and the observation that patients with Parkinson's disease on dopamine agonists develop impulse control disorders. Although the effects of dopamine on reactive inhibition have been studied, substantial literature on the role of dopamine on proactive inhibition is lacking. To fill this gap, we devised a double-blind, placebo-controlled study of 1 mg ropinirole (a dopamine agonist) on response inhibition in healthy volunteers. We found that whilst reactive inhibition was unchanged, proactive inhibition was impaired when participants were on ropinirole relative to when on placebo. To investigate how ropinirole mediated this effect on proactive inhibition, we used hierarchical drift-diffusion modelling. We found that ropinirole impaired the ability to raise the decision threshold when proactive inhibition was called upon. Our results provide novel evidence that an acute dose of ropinirole selectively reduces proactive inhibition in healthy participants. These results may help explain how ropinirole induces impulse control disorders in susceptible patients with Parkinson's disease.",2020,"We found that whilst reactive inhibition was unchanged, proactive inhibition was impaired when participants were on ropinirole relative to when on placebo.","[""susceptible patients with Parkinson's disease"", 'healthy volunteers', ""patients with Parkinson's disease on dopamine agonists develop impulse control disorders"", 'healthy adults', 'healthy participants']","['Dopamine', 'Ropinirole', 'ropinirole', 'ropinirole (a dopamine agonist', 'dopamine', 'placebo']","['reactive inhibition', 'proactive inhibition']","[{'cui': 'C0231204', 'cui_str': 'Susceptible'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0178601', 'cui_str': 'Dopamine receptor agonist'}, {'cui': 'C0021122', 'cui_str': 'Impulse control disorder'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0244821', 'cui_str': 'ropinirole'}, {'cui': 'C0178601', 'cui_str': 'Dopamine receptor agonist'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0034750', 'cui_str': 'Inhibition, Reactive'}, {'cui': 'C0033199', 'cui_str': 'Inhibition, Proactive'}]",,0.116831,"We found that whilst reactive inhibition was unchanged, proactive inhibition was impaired when participants were on ropinirole relative to when on placebo.","[{'ForeName': 'Vishal', 'Initials': 'V', 'LastName': 'Rawji', 'Affiliation': 'Department of Clinical and Movement Neurosciences, UCL Queen Square Institute of Neurology, Queen Square, London, UK. Electronic address: vishal.rawji.11@ucl.ac.uk.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Rocchi', 'Affiliation': 'Department of Clinical and Movement Neurosciences, UCL Queen Square Institute of Neurology, Queen Square, London, UK.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Foltynie', 'Affiliation': 'Department of Clinical and Movement Neurosciences, UCL Queen Square Institute of Neurology, Queen Square, London, UK.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Rothwell', 'Affiliation': 'Department of Clinical and Movement Neurosciences, UCL Queen Square Institute of Neurology, Queen Square, London, UK.'}, {'ForeName': 'Marjan', 'Initials': 'M', 'LastName': 'Jahanshahi', 'Affiliation': 'Department of Clinical and Movement Neurosciences, UCL Queen Square Institute of Neurology, Queen Square, London, UK.'}]",Neuropharmacology,['10.1016/j.neuropharm.2020.108278']
2461,32781283,Efficacy of Huoxiang Zhengqi dropping pills and Lianhua Qingwen granules in treatment of COVID-19: A randomized controlled trial.,"BACKGROUND


With the global epidemic of coronavirus disease (COVID-19), China has made progress in the prevention and control of the epidemic, and traditional Chinese medicine (TCM) has played a key role in dealing with the disease's effects on the respiratory system. This randomized controlled clinical trial evaluated the clinical efficacy and prognosis of Huoxiang Zhengqi dropping pills and Lianhua Qingwen granules in patients with COVID-19.
METHODS


A total of 283 patients participated in this clinical trial, and participants were randomly assigned to receive either 1) Huoxiang Zhengqi dropping pills and Lianhua Qingwen granules or 2) Linahua granules, both combined with western medicine, or 3) western medicine alone for 14 days. At the end of the trial, the improvement and resolution rates of clinical symptoms and the rate of patients who progressed to severe disease status were evaluated.
RESULTS


After 14 days of treatment, there was no significant difference in the improvement rate of clinical symptoms among the three groups (P > 0.05). Huoxiang Zhengqi dropping pills combined with Lianhua Qingwen granules has advantages in the treatment of nausea, vomiting and limb soreness. During treatment, all participants were treated with western medicine, and there was a significant difference in the use of macrolides among the three groups (P < 0.05). Specifically, the utilization rate of antibiotics in the western medicine group was significantly greater than that of the other two groups. Among the 182 diagnosed patients who completed this clinical trial, 13 patients progressed to severe disease, including one case in the Huoxiang + Lianhua group (1.6 %), five cases in the Lianhua group (8.6 %), and seven cases in the western medicine group (11.1 %). There was no statistical differences in this rate among the three groups (P >  0.05). However, the proportion of patients who progressed to severe disease in the Huoxiang + Lianhua group was the lowest, suggesting that the combination of TCM with western medicine has a potential advantage in improving the prognosis of patients with COVID-19.
CONCLUSION


The use of Huoxiang Zhengqi dropping pills and Lianhua Qingwen granules combined with western medicine may have clinical advantages for COVID-19 patients in improving clinical symptoms, reducing utilization rate of anti-infective drugs, and improving patient prognosis, which could pave the way for the use of complementary medicine in treating this infection.",2020,"After 14 days of treatment, there was no significant difference in the improvement rate of clinical symptoms among the three groups (P > 0.05).","['patients with COVID-19', 'COVID-19', '283 patients participated in this clinical trial, and participants', '182 diagnosed patients']","['Huoxiang Zhengqi dropping pills and Lianhua Qingwen granules', 'Huoxiang Zhengqi dropping pills and Lianhua Qingwen granules combined with western medicine']","['utilization rate of antibiotics', 'improvement rate of clinical symptoms', 'nausea, vomiting and limb soreness', 'severe disease']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C4708786', 'cui_str': '283'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C1871293', 'cui_str': 'Huoxiang-zhengqi'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0010837', 'cui_str': 'Cytoplasmic Granules'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0234233', 'cui_str': 'Soreness'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",283.0,0.0509695,"After 14 days of treatment, there was no significant difference in the improvement rate of clinical symptoms among the three groups (P > 0.05).","[{'ForeName': 'Mingzhong', 'Initials': 'M', 'LastName': 'Xiao', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: xmz0001@sohu.com.'}, {'ForeName': 'Jiaxing', 'Initials': 'J', 'LastName': 'Tian', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China. Electronic address: tina_yai@126.com.""}, {'ForeName': 'Yana', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: nana680@sina.com.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 510247444@qq.com.'}, {'ForeName': 'Xiaojun', 'Initials': 'X', 'LastName': 'Min', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: Mxj922@sohu.com.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Lv', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 562163610@qq.com.'}, {'ForeName': 'Miao', 'Initials': 'M', 'LastName': 'Peng', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 719834165@qq.com.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Beijing University of Chinese Medicine, Beijing, 10029, China. Electronic address: novelzhang@sina.com.'}, {'ForeName': 'Dengying', 'Initials': 'D', 'LastName': 'Yan', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: yandengying@outlook.com.'}, {'ForeName': 'Suping', 'Initials': 'S', 'LastName': 'Lang', 'Affiliation': 'GCP ClinPlus Co., Ltd., Beijing, 100160, China. Electronic address: suping.lang@gcp-clinplus.com.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: r.e.x@163.com.'}, {'ForeName': 'An', 'Initials': 'A', 'LastName': 'Fan', 'Affiliation': 'GCP ClinPlus Co., Ltd., Beijing, 100160, China. Electronic address: an.fan@gcp-clinplus.com.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Ke', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 24929135@qq.com.'}, {'ForeName': 'Xiuyang', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China. Electronic address: leexiuyang@126.com.""}, {'ForeName': 'Binbin', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 291560898@qq.com.'}, {'ForeName': 'Manhong', 'Initials': 'M', 'LastName': 'Jiang', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 43166472@qq.com.'}, {'ForeName': 'Quan', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 48302079@qq.com.'}, {'ForeName': 'Jinyue', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 627525649@qq.com.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 491193488@qq.com.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Zhu', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 87068066@qq.com.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Zeng', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 309452513@qq.com.'}, {'ForeName': 'Chengyin', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 40691534@qq.com.'}, {'ForeName': 'Yujiao', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China. Electronic address: luoyuorz@163.com.""}, {'ForeName': 'Haoran', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China. Electronic address: dr-whr@foxmail.com.""}, {'ForeName': 'Jiaran', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China. Electronic address: 502230253@qq.com.""}, {'ForeName': 'Fengmei', 'Initials': 'F', 'LastName': 'Lian', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China. Electronic address: lfm565@sohu.com.""}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: Lixiaodong555@126.com.'}, {'ForeName': 'Xiaolin', 'Initials': 'X', 'LastName': 'Tong', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China. Electronic address: tongxiaolin@vip.163.com.""}]",Pharmacological research,['10.1016/j.phrs.2020.105126']
2462,32781360,"Intrauterine administration of autologous hCG- activated peripheral blood mononuclear cells improves pregnancy outcomes in patients with recurrent implantation failure; A double-blind, randomized control trial study.","We aimed to investigate the effect of intrauterine administration of autologous hCG-activated PBMCs in RIF women with low Th-17/Treg cell ratio. 248 women with a history of implantation failure volunteered to receive PBMC-therapy. After immunologic consultation and doing flow cytometry analysis, 100 women with at least three IVF/ET failure who had low Th-17/Treg ratio in comparison with healthy control were enrolled in this study. These 100 patients were randomly divided into two groups as PBMC receiving (n = 50) and controls (n = 50). Then PBMCs were obtained from patients and treated with hCG for 48 h. Afterward, PBMCs were administered into the uterine cavity of the patient in the study group, two days before ET. The concentration of inflammatory cytokines was examined in the supernatant of cultured PBMCs after 2, 24, and 48 h of incubation using the ELISA method. The frequency of Th-17, Treg, and the Th-17/Treg ratio was significantly lower in RIF women than the healthy controls (P < 0.0001). The secretion of inflammatory cytokines was significantly higher after 48 h compared to 2 and 24 h (P < 0.0001). The pregnancy and live birth rate were significantly increased in women undergoing the PBMC-therapy compared to control (PBS-injecting) group (P = 0.032 and P = 0.047, respectively). The miscarriage rate was considerably lower in PBMC-therapy group (P = 0.029). Our findings suggest that intrauterine administration of autologous in vitro hCG-activated PBMCs improves pregnancy outcomes in patients with at least three IVF/ET failures.",2020,The secretion of inflammatory cytokines was significantly higher after 48 h compared to 2 and 24 h (P < 0.0001).,"['100 women with at least three IVF/ET failure who had low Th-17/Treg ratio in comparison with healthy control', 'patients with recurrent implantation failure', '100 patients', 'RIF women with low Th-17/Treg cell ratio', '248 women with a history of implantation failure volunteered to receive']","['hCG', 'autologous hCG-activated PBMCs', 'autologous hCG- activated peripheral blood mononuclear cells', 'PBMC-therapy']","['concentration of inflammatory cytokines', 'pregnancy and live birth rate', 'pregnancy outcomes', 'miscarriage rate', 'secretion of inflammatory cytokines', 'frequency of Th-17, Treg, and the Th-17/Treg ratio']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0035608', 'cui_str': 'Rifampin'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C1141639', 'cui_str': 'Human chorionic gonadotropin'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",248.0,0.138794,The secretion of inflammatory cytokines was significantly higher after 48 h compared to 2 and 24 h (P < 0.0001).,"[{'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Pourmoghadam', 'Affiliation': 'Drug Applied Research Center, Tabriz University of Medical Sciences, Tabriz, Iran; Student Research Committee, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Mohammad Sadegh', 'Initials': 'MS', 'LastName': 'Soltani-Zangbar', 'Affiliation': 'Stem Cell Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Golshan', 'Initials': 'G', 'LastName': 'Sheikhansari', 'Affiliation': 'Drug Applied Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Ramyar', 'Initials': 'R', 'LastName': 'Azizi', 'Affiliation': 'Drug Applied Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Shadi', 'Initials': 'S', 'LastName': 'Eghbal-Fard', 'Affiliation': 'Stem Cell Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Mohammadi', 'Affiliation': 'Non-Communicable Diseases Research Center, Alborz University of Medical Sciences, Karaj, Iran.'}, {'ForeName': 'Homayoon', 'Initials': 'H', 'LastName': 'Siahmansouri', 'Affiliation': 'Stem Cell Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Leili', 'Initials': 'L', 'LastName': 'Aghebati-Maleki', 'Affiliation': 'Immunology Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Shahla', 'Initials': 'S', 'LastName': 'Danaii', 'Affiliation': 'Gynecology Department, Eastern Azerbaijan ACECR ART center, Eastern Azerbaijan branch of ACECR, Tabriz, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Mehdizadeh', 'Affiliation': 'Endocrine Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Hojjat-Farsangi', 'Affiliation': 'Department of Oncology-Pathology, Immune and Gene Therapy Lab, Cancer Center Karolinska (CCK), Karolinska University Hospital Solna and Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Roza', 'Initials': 'R', 'LastName': 'Motavalli', 'Affiliation': 'Stem Cell Research Center, Tabriz University of Medical Sciences, Tabriz, Iran; Kidney Disease Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Yousefi', 'Affiliation': 'Stem Cell Research Center, Tabriz University of Medical Sciences, Tabriz, Iran; Kidney Disease Research Center, Tabriz University of Medical Sciences, Tabriz, Iran; Department of Immunology, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: Yousefime@tbzmed.ac.ir.'}]",Journal of reproductive immunology,['10.1016/j.jri.2020.103182']
2463,32781397,Parental sensitivity mediates the sustained effect of Attachment and Biobehavioral Catch-up on cortisol in middle childhood: A randomized clinical trial.,"IMPORTANCE


Parenting interventions have been found to normalize cortisol regulation among high-risk children early in development; it is important to investigate the sustainability of these effects and their mechanisms, given the maladaptive outcomes associated with cortisol dysregulation.
OBJECTIVE


To determine whether the Attachment and Biobehavioral Catch-up (ABC) intervention, implemented in infancy, predicts cortisol regulation in middle childhood via changes in early parental sensitivity.
DESIGN


Double blind randomized clinical trial design; started January 2006, the follow-up for this project concluded March 2016.
SETTING


Parents of children under age 2 referred from child protective services agencies in a large, mid-Atlantic city.
PARTICIPANTS


103 parent-child dyads (45.6% female children) with histories of child protective services involvement, randomly assigned to receive ABC (n = 45) or a control intervention (n = 58); in infancy, the children's ages ranged from 1.60 to 25.30 months (M = 9.87 months); at the middle childhood follow-up, they ranged from 8.0 to 11.0 years old (M = 8.52 years).
INTERVENTIONS


Both conditions included 10-week, in-home, manualized interventions. The experimental condition, ABC, has 3 primary targets for parents: increasing nurturance to child distress, increasing following the child's lead, and decreasing frightening behavior. The control intervention, Developmental Education for Families (DEF), is an adaptation of a program focused on enhancing cognitive and language development.
MAIN OUTCOMES AND MEASURES


Parental sensitivity was coded from a semi-structured interaction task between the parent and child in early childhood. Middle childhood diurnal cortisol slopes were modeled by collecting salivary cortisol samples from children at wake-up and bedtime over the course of 3 consecutive days.
RESULTS


ABC participation in infancy was associated with increased parental sensitivity post-intervention, β = 0.28, p = .004, and this increased sensitivity predicted steeper decline across the day in children's cortisol concentration in middle childhood, β = -.53, p = .002. The indirect effect of ABC on cortisol regulation via sensitivity was significant, β = -0.15, p = .038.
CONCLUSIONS AND RELEVANCE


ABC has an indirect effect on middle childhood diurnal cortisol regulation via parental sensitivity; future research should seek to determine how this enhanced neurobiological regulation relates to children's behavioral, socioemotional, and psychological outcomes.
TRIAL REGISTRATION


clinicaltrials.gov Identifier: NCT02093052.",2020,"RESULTS


ABC participation in infancy was associated with increased parental sensitivity post-intervention, β = 0.28, p = .004, and this increased sensitivity predicted steeper decline across the day in children's cortisol concentration in middle childhood, β = -.53, p = .002.","['Parents of children under age 2 referred from child protective services agencies in a large, mid-Atlantic city', ""n = 58); in infancy, the children's ages ranged from 1.60 to 25.30 months (M = 9.87 months); at the middle childhood follow-up, they ranged from 8.0 to 11.0 years old (M = 8.52 years"", 'middle childhood', '103 parent-child dyads (45.6% female children) with histories of child protective services involvement']","['control intervention, Developmental Education for Families (DEF', 'Attachment and Biobehavioral Catch-up (ABC) intervention', 'ABC', 'control intervention']","['Middle childhood diurnal cortisol slopes', 'cortisol regulation via sensitivity']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0681158', 'cui_str': 'Child Welfare Agencies'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0231330', 'cui_str': 'Infancy'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0870604', 'cui_str': 'Female child'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0458003', 'cui_str': 'Developmental'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0231617', 'cui_str': 'Catch'}]","[{'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]",,0.0395333,"RESULTS


ABC participation in infancy was associated with increased parental sensitivity post-intervention, β = 0.28, p = .004, and this increased sensitivity predicted steeper decline across the day in children's cortisol concentration in middle childhood, β = -.53, p = .002.","[{'ForeName': 'Mallory', 'Initials': 'M', 'LastName': 'Garnett', 'Affiliation': 'University of Delaware, Department of Psychological and Brain Sciences, 108 Wolf Hall, Newark, DE, 19718, United States. Electronic address: mgarnett@udel.edu.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Bernard', 'Affiliation': 'Stony Brook University, Psychology B Building, Stony Brook, NY, 11794, United States.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Hoye', 'Affiliation': 'University of Delaware, Department of Psychological and Brain Sciences, 108 Wolf Hall, Newark, DE, 19718, United States.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Zajac', 'Affiliation': 'University of Delaware, Department of Psychological and Brain Sciences, 108 Wolf Hall, Newark, DE, 19718, United States.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Dozier', 'Affiliation': 'University of Delaware, Department of Psychological and Brain Sciences, 108 Wolf Hall, Newark, DE, 19718, United States.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104809']
2464,32785587,Effects of Question Type and Order When Measuring Peak Consumption of Risky Drinking Events.,"AIMS


There is new interest in measuring alcohol consumption during risky drinking events, but there is little guidance on how to best ask such questions. In this study, we contrast two different types of questions on peak consumption over a single heavy drinking occasion. We used a general question that ask respondents to recall the total amount consumed (total consumption question), and location-specific questions that ask respondents to recall consumption in each drinking location (location-specific peak consumption, LSPC).
METHODS


Heavy drinkers (≥11 Australian Standard Drinks (ASD) per occasion for males, ≥8 for females) from the second wave of a prospective cohort study were recruited via landline random digit dial from Melbourne in 2012. Respondents were randomly assigned to surveys of different question order, and either first received total consumption (n = 127) or LSPC questions (n = 147). T-tests compared peak consumption between categories stratified by sex and consumption tercile.
RESULTS


Mean peak consumption was 12.5 ASD. Irrespective of question order, consumption amounts for total consumption and LSPC questions were not significantly different for both sexes. However, drinkers in the highest tercile asked LSPC questions first provided significantly higher consumption estimates in response to the total consumption question than in response to the LSPC questions.
CONCLUSION


At a population level, LSPC and total consumption questions produce similar estimates of peak consumption for risky drinking events. Except for heavy drinkers, general consumption questions may be sufficient when asking about these drinking events in consumption surveys, without the greater response burden of longer LSPC questions.",2020,"Irrespective of question order, consumption amounts for total consumption and LSPC questions were not significantly different for both sexes.","['Heavy drinkers (≥11 Australian Standard Drinks (ASD) per occasion for males, ≥8 for females) from the second wave of a prospective cohort study were recruited via landline random digit dial from Melbourne in 2012']","['total consumption (n\xa0=\xa0127) or LSPC questions', 'Question Type and Order']","['total consumption and LSPC questions', 'Mean peak consumption', 'Peak Consumption of Risky Drinking Events']","[{'cui': 'C0001969', 'cui_str': 'Alcohol intoxication'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C4284072', 'cui_str': 'Order document'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",,0.0288463,"Irrespective of question order, consumption amounts for total consumption and LSPC questions were not significantly different for both sexes.","[{'ForeName': 'Jun-Ting', 'Initials': 'JT', 'LastName': 'Yeung', 'Affiliation': 'Burnet Institute, Melbourne, VIC, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Livingston', 'Affiliation': 'Centre for Alcohol Policy Research, La Trobe University, Bundoora, VIC, Australia.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Callinan', 'Affiliation': 'Centre for Alcohol Policy Research, La Trobe University, Bundoora, VIC, Australia.'}, {'ForeName': 'Cassandra', 'Initials': 'C', 'LastName': 'Wright', 'Affiliation': 'Burnet Institute, Melbourne, VIC, Australia.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Kuntsche', 'Affiliation': 'Centre for Alcohol Policy Research, La Trobe University, Bundoora, VIC, Australia.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Room', 'Affiliation': 'Centre for Alcohol Policy Research, La Trobe University, Bundoora, VIC, Australia.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Dietze', 'Affiliation': 'Burnet Institute, Melbourne, VIC, Australia.'}]","Alcohol and alcoholism (Oxford, Oxfordshire)",['10.1093/alcalc/agaa076']
2465,32796401,"A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Saccharomyces boulardii in Infants and Children With Acute Diarrhea.","AIM


This study was designed to assess the efficacy and safety of Saccharomyces cerevisiae variant boulardii CNCM I-3799 (S. boulardii CNCM I-3799) in the management of acute diarrhea in children.
METHODS


A total of 100 infants and children 3-36 months of age with acute diarrhea received medical care according to the World Health Organization guidelines on the management of acute diarrhea in children and were randomly allocated to the probiotic group (S. boulardii CNCM I-3799 at a daily dose of 5 billion CFU twice daily) or to the placebo group. Infants and children were treated for 5 days and an extended follow-up was planned 1 and 2 months after the end of the treatment period. Primary endpoint was the time of recovery from diarrhea defined as the duration of diarrhea. Other parameters, such as frequency and consistency of stools, associated with the severity of diarrhea episodes were defined as secondary endpoints.
RESULTS


The administration of S. boulardii CNCM I-3799 was associated with beneficial effects on duration and severity of diarrhea. The time of recovery from diarrhea was significantly shorter in the probiotic group compared with the placebo group (65.8 ± 12 hours vs. 95.3 ± 17.6 hours, P = 0.0001). Faster remission in the probiotic group was also demonstrated by a shorter time before the first episode of semisolid stool [-23.5 hours, diff (95% CI): -7.99 (-31.49 to -15.51), P = 0.0001] and the faster normalization of stool consistency. S. boulardii CNCM I-3799 was well tolerated.
CONCLUSION


S. boulardii CNCM I-3799 supplementation in children with acute diarrhea was shown effective in reducing the duration and severity of diarrhea in infants and children.",2020,The administration of S. boulardii CNCM I-3799 was associated with beneficial effects on duration and severity of diarrhea.,"['Infants and Children With Acute Diarrhea', '100 infants and children aged 3-36 months with acute diarrhea received medical care according to the World Health Organization guidelines on the management of acute diarrhea in children', 'acute diarrhea in children', 'children with acute diarrhea']","['Saccharomyces boulardii', 'Placebo', 'S. boulardii CNCM I-3799 supplementation', 'Saccharomyces cerevisiae variant boulardii CNCM I-3799 (S. boulardii CNCM I-3799', 'probiotic group (S. boulardii CNCM I-3799', 'placebo']","['faster normalization of stool consistency', 'time of recovery from diarrhea defined as the duration of diarrhea', 'severity of diarrhea episodes', 'tolerated', 'frequency and consistency of stools', 'time of recovery from diarrhea', 'Faster remission', 'duration and severity of diarrhea']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0740441', 'cui_str': 'Acute diarrhea'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0496675', 'cui_str': 'Medical care'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0772093', 'cui_str': 'Saccharomyces boulardii'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0036025', 'cui_str': 'Saccharomyces cerevisiae'}, {'cui': 'C0205419', 'cui_str': 'Variant'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0426740', 'cui_str': 'Consistency of stool'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}]",100.0,0.251802,The administration of S. boulardii CNCM I-3799 was associated with beneficial effects on duration and severity of diarrhea.,"[{'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Mourey', 'Affiliation': 'From the Research & Applications, Gnosis by Lesaffre, Lesaffre International, Marcq-en-Barœul, France.'}, {'ForeName': 'Varun', 'Initials': 'V', 'LastName': 'Sureja', 'Affiliation': 'Sundyota Numandis Probioceuticals Pvt. Ltd.'}, {'ForeName': 'Dharmeshkumar', 'Initials': 'D', 'LastName': 'Kheni', 'Affiliation': 'Sundyota Numandis Probioceuticals Pvt. Ltd.'}, {'ForeName': 'Parthiv', 'Initials': 'P', 'LastName': 'Shah', 'Affiliation': 'Hitarth Children Hospital.'}, {'ForeName': 'Devang', 'Initials': 'D', 'LastName': 'Parikh', 'Affiliation': 'Bakeri Medical Research Centre.'}, {'ForeName': 'Unmesh', 'Initials': 'U', 'LastName': 'Upadhyay', 'Affiliation': 'Iqra Hospital.'}, {'ForeName': 'Milan', 'Initials': 'M', 'LastName': 'Satia', 'Affiliation': 'Ethicare Clinical Trial Services, Ahmedabad, India.'}, {'ForeName': 'Dhara', 'Initials': 'D', 'LastName': 'Shah', 'Affiliation': 'Ethicare Clinical Trial Services, Ahmedabad, India.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Troise', 'Affiliation': 'From the Research & Applications, Gnosis by Lesaffre, Lesaffre International, Marcq-en-Barœul, France.'}, {'ForeName': 'Amélie', 'Initials': 'A', 'LastName': 'Decherf', 'Affiliation': 'From the Research & Applications, Gnosis by Lesaffre, Lesaffre International, Marcq-en-Barœul, France.'}]",The Pediatric infectious disease journal,['10.1097/INF.0000000000002849']
2466,32798022,Resection following concurrent chemotherapy and high-dose radiation for stage IIIA non-small cell lung cancer.,"OBJECTIVE


Concern exists regarding surgery after thoracic radiation. We aimed to assess early results of anatomic resection following induction therapy with platinum-based chemotherapy and full-dose thoracic radiation for resectable N2+ stage IIIA non-small cell lung cancer.
METHODS


Two prospective trials were recently conducted by NRG Oncology in patients with resectable N2+ stage IIIA non-small cell lung cancer with the primary end point of mediastinal node sterilization following concurrent full-dose chemoradiotherapy (Radiation Therapy Oncology Group trials 0229 and 0839). All surgeons demonstrated postinduction resection expertise. Induction consisted of weekly carboplatin (area under the curve, 2.0) and paclitaxel (50 mg/m 2 ) and concurrent thoracic radiation 60 Gy (0839)/61.2 Gy (0229) in 30 fractions. Patients in study 0839 were randomized 2:1 to weekly panitumumab + chemoradiotherapy or chemoradiotherapy alone during induction. Primary results were similar in all treatment arms and reported previously. Short-term surgical outcomes are reported here.
RESULTS


One hundred twenty-six patients enrolled; 93 (74%) had anatomic resection, 77 underwent lobectomy, and 16 underwent extended resection. Microscopically margin-negative resections occurred in 85 (91%). Fourteen (15%) resections were attempted minimally invasively, including 2 converted without event. Grade 3 or 4 surgical adverse events were reported in 26 (28%), 30-day mortality in 4 (4%) and 90-day mortality in 5 (5%). Patients undergoing extended resection experienced similar rates of grade 3 or 4 adverse events (odds ratio, 0.95; 95% confidence interval, 0.42-3.8) but higher 30-day (1.3% vs 18.8%) (odds ratio, 17.54; 95% confidence interval, 1.75-181.8) and 90-day mortality (2.6% vs 18.8%) (odds ratio, 8.65; 95% confidence interval, 1.3-56.9).
CONCLUSIONS


Lobectomy was performed safely following full-dose concurrent chemoradiotherapy in these multi-institutional prospective trials; however, increased mortality was noted with extended resections.",2020,"Patients undergoing extended resection experienced similar rates of grade 3 or 4 adverse events (odds ratio, 0.95; 95% confidence interval, 0.42-3.8) but higher 30-day (1.3% vs 18.8%) (odds ratio, 17.54; 95% confidence interval, 1.75-181.8) and 90-day mortality (2.6% vs 18.8%) (odds ratio, 8.65; 95% confidence interval, 1.3-56.9).
","['patients with resectable N2+ stage IIIA non-small cell lung cancer with the primary end point of mediastinal node sterilization following concurrent full-dose chemoradiotherapy (Radiation Therapy Oncology Group trials 0229 and 0839', 'One hundred twenty-six patients enrolled; 93 (74%) had anatomic resection, 77 underwent lobectomy, and 16 underwent extended resection', 'stage IIIA non-small cell lung cancer']","['anatomic resection following induction therapy with platinum-based chemotherapy and full-dose thoracic radiation', 'paclitaxel', 'carboplatin', 'concurrent chemotherapy and high-dose radiation', 'panitumumab\xa0+\xa0chemoradiotherapy or chemoradiotherapy']","['90-day mortality', 'Microscopically margin-negative resections', 'rates of grade 3 or 4 adverse events', 'mortality', '30-day mortality', 'Grade 3 or 4 surgical adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278983', 'cui_str': 'Non-small cell lung cancer stage IIIA'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0588055', 'cui_str': 'Mediastinal lymph node group'}, {'cui': 'C0038280', 'cui_str': 'Sterilization'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0023928', 'cui_str': 'Lobectomy'}, {'cui': 'C0231448', 'cui_str': 'Extension'}]","[{'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0879427', 'cui_str': 'panitumumab'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}]",839.0,0.482473,"Patients undergoing extended resection experienced similar rates of grade 3 or 4 adverse events (odds ratio, 0.95; 95% confidence interval, 0.42-3.8) but higher 30-day (1.3% vs 18.8%) (odds ratio, 17.54; 95% confidence interval, 1.75-181.8) and 90-day mortality (2.6% vs 18.8%) (odds ratio, 8.65; 95% confidence interval, 1.3-56.9).
","[{'ForeName': 'Jessica S', 'Initials': 'JS', 'LastName': 'Donington', 'Affiliation': 'Department of Department of Surgery, University of Chicago Medicine and Biologic Sciences, Chicago, Ill. Electronic address: jdonington@uchicago.edu.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Paulus', 'Affiliation': 'Department of Department of Surgery, University of Chicago Medicine and Biologic Sciences, Chicago, Ill.'}, {'ForeName': 'Martin J', 'Initials': 'MJ', 'LastName': 'Edelman', 'Affiliation': 'Division of Medical Oncology, Department of Medicine, University of Maryland Medical Center, Baltimore, Md.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Krasna', 'Affiliation': 'Department of Surgery, Jersey Shore University Medical Center, Neptune City, NJ.'}, {'ForeName': 'Quynh-Thu', 'Initials': 'QT', 'LastName': 'Le', 'Affiliation': 'Department of Radiation Oncology, Stanford Cancer Institute, Stanford, Calif.'}, {'ForeName': 'Mohan', 'Initials': 'M', 'LastName': 'Suntharalingam', 'Affiliation': 'Department of Radiation Oncology, University of Maryland School of Medicine, Baltimore, Md.'}, {'ForeName': 'Billy W', 'Initials': 'BW', 'LastName': 'Loo', 'Affiliation': 'Department of Radiation Oncology, Stanford Cancer Institute, Stanford, Calif.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Hu', 'Affiliation': 'NRG Oncology Statistics and Data Management Center, Philadelphia, Pa; Division of Biostatistics and Bioinformatics, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, Md.'}, {'ForeName': 'Jeffrey D', 'Initials': 'JD', 'LastName': 'Bradley', 'Affiliation': 'Department of Radiation Oncology, Winship Cancer Institute, Emory University, Atlanta, Ga.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of thoracic and cardiovascular surgery,['10.1016/j.jtcvs.2020.03.171']
2467,32800383,"Effects of Food on the Pharmacokinetic Properties of Surufatinib: A Phase I, Single-dose, Randomized, Open-label Crossover Study in Healthy Subjects.","PURPOSE


Surufatinib is a potent and orally active small-molecule tyrosine kinase inhibitor targeting VEGFRs 1 to 3, FGFR-1, and CSF-1R, and thus may exert antitumor and antiangiogenic effects. The objective of this study was to determine the tolerability and effects of food intake on the pharmacokinetic properties of surufatinib in healthy Chinese subjects.
METHODS


A total of 24 healthy Chinese male subjects aged between 18 and 55 years were enrolled. Subjects were administered a single dose of surufatinib 250-mg capsules in the fasted and fed states in succession. Pharmacokinetic analysis was performed through the collection of blood samples at predose and at several time points after surufatinib administration. Tolerability assessments comprised physical examination including vital sign measurements, laboratory testing, and ECG to determine adverse events (AEs).
FINDINGS


The 90% CIs of the geometric mean ratios of AUC 0-t  and AUC 0-∞  in the fasted and fed states was within 0.80 to 1.25; and for C max , within 0.70 to 1.43, indicating that food had no effect on the bioavailability of surufatinib in these healthy Chinese male subjects. Food intake delayed the time to peak absorption of surufatinib, as the median T max  in the fed state was longer than that in the fasted state (4.0 vs 2.0 h). Surufatinib was marginally excreted from urine (mean [SD] cumulative excretion fraction, 1.2% [0.4%]). AEs occurred in 7 of the 24 subjects (29.2%) and included upper respiratory tract infection, dizziness, merycism, intervertebral disc protrusion, influenza-like disease, hematuria, prostatitis, and elevated blood urea nitrogen. All AEs were grade 1 or 2.
IMPLICATIONS


The bioavailability of surufatinib was not affected by food intake prior to dosing. However, food intake led to delated T max  of surufatinib. The tolerability of a single oral dose of surufatinib 250 mg in the fasted and fed states was favorable in these healthy Chinese male subjects. These results indicate that surufatinib capsules could be administered before or after meals. ClinicalTrials.gov identifier: NCT02320409.",2020,"AEs occurred in 7 of the 24 subjects (29.2%) and included upper respiratory tract infection, dizziness, merycism, intervertebral disc protrusion, influenza-like disease, hematuria, prostatitis, and elevated blood urea nitrogen.","['24 healthy Chinese male subjects aged between 18 and 55 years were enrolled', 'healthy Chinese male subjects', 'healthy Chinese subjects', 'Surufatinib', 'Healthy Subjects']",['food intake'],"['Food intake delayed the time to peak absorption of surufatinib, as the median T max', 'bioavailability of surufatinib', 'Tolerability assessments comprised physical examination including vital sign measurements, laboratory testing, and ECG to determine adverse events (AEs', 'geometric mean ratios of AUC 0-t  and AUC 0-∞', 'included upper respiratory tract infection, dizziness, merycism, intervertebral disc protrusion, influenza-like disease, hematuria, prostatitis, and elevated blood urea nitrogen']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0013470', 'cui_str': 'Eating'}]","[{'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0041912', 'cui_str': 'Upper respiratory infection'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0154575', 'cui_str': 'Rumination disorder'}, {'cui': 'C0242362', 'cui_str': 'Intervertebral disc prolapse'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0018965', 'cui_str': 'Blood in urine'}, {'cui': 'C0033581', 'cui_str': 'Prostatitis'}, {'cui': 'C0151539', 'cui_str': 'Blood urea increased'}]",24.0,0.0918436,"AEs occurred in 7 of the 24 subjects (29.2%) and included upper respiratory tract infection, dizziness, merycism, intervertebral disc protrusion, influenza-like disease, hematuria, prostatitis, and elevated blood urea nitrogen.","[{'ForeName': 'Hongjie', 'Initials': 'H', 'LastName': 'Qian', 'Affiliation': 'Central Laboratory, Shanghai Xuhui Central Hospital/Zhongshan-Xuhui Hospital, Fudan University, Shanghai, China; Shanghai Engineering Research Center of Phase I Clinical Research and Quality Consistency Evaluation for Drugs, Shanghai, China.'}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Central Laboratory, Shanghai Xuhui Central Hospital/Zhongshan-Xuhui Hospital, Fudan University, Shanghai, China; Shanghai Engineering Research Center of Phase I Clinical Research and Quality Consistency Evaluation for Drugs, Shanghai, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'Central Laboratory, Shanghai Xuhui Central Hospital/Zhongshan-Xuhui Hospital, Fudan University, Shanghai, China; Shanghai Engineering Research Center of Phase I Clinical Research and Quality Consistency Evaluation for Drugs, Shanghai, China.'}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'Central Laboratory, Shanghai Xuhui Central Hospital/Zhongshan-Xuhui Hospital, Fudan University, Shanghai, China; Shanghai Engineering Research Center of Phase I Clinical Research and Quality Consistency Evaluation for Drugs, Shanghai, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Emergency, Shanghai Xuhui Central Hospital/Zhongshan-Xuhui Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Jingying', 'Initials': 'J', 'LastName': 'Jia', 'Affiliation': 'Central Laboratory, Shanghai Xuhui Central Hospital/Zhongshan-Xuhui Hospital, Fudan University, Shanghai, China; Shanghai Engineering Research Center of Phase I Clinical Research and Quality Consistency Evaluation for Drugs, Shanghai, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Yu', 'Affiliation': 'Central Laboratory, Shanghai Xuhui Central Hospital/Zhongshan-Xuhui Hospital, Fudan University, Shanghai, China; Shanghai Engineering Research Center of Phase I Clinical Research and Quality Consistency Evaluation for Drugs, Shanghai, China.'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': 'Hutchison MediPharma Ltd, Shanghai, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Sai', 'Affiliation': 'Hutchison MediPharma Ltd, Shanghai, China.'}, {'ForeName': 'Weiguo', 'Initials': 'W', 'LastName': 'Su', 'Affiliation': 'Hutchison MediPharma Ltd, Shanghai, China.'}, {'ForeName': 'Yanmei', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Central Laboratory, Shanghai Xuhui Central Hospital/Zhongshan-Xuhui Hospital, Fudan University, Shanghai, China; Shanghai Engineering Research Center of Phase I Clinical Research and Quality Consistency Evaluation for Drugs, Shanghai, China. Electronic address: ymliu@shxh-centerlab.com.'}]",Clinical therapeutics,['10.1016/j.clinthera.2020.07.010']
2468,32807749,"CSP01, a Novel Superabsorbent Hydrogel, Reduces Colonic Transit Time in Patients With Chronic Idiopathic Constipation in a Randomized, Double-blind, Controlled Pilot Clinical Trial.","Background/Aims


CSP01 is a novel superabsorbent hydrogel that absorbs gastrointestinal fluids and maintains high viscoelastic properties into the colon, where these fluids are released.
Methods


We conducted a single-center, randomized, double-blind, parallel-group, placebo-controlled pilot study comparing change in colonic transit time (CTT) among patients with chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C) treated for 21 days with either CSP01 hydrogel, active control (carboxymethylcellulose [CMC]) or placebo. CTT was measured using wireless motility capsule transit testing at pre-treatment and end-of-treatment. The primary endpoint was change in CTT.
Results


Forty subjects (20 CSP01, 11 CMC, 9 placebo) were enrolled and 38 completed the study. There was no significant change in mean CTT by treatment group ( P  = 0.297). In the placebo group, CTT increased by 15.3 minutes between baseline and end of treatment, increased by 366.4 minutes for CMC, and decreased by 727.4 minutes for CSP01. In post hoc analyses among those with CIC, mean CTT decreased by 1079 minutes for CSP01 ( P  = 0.025 compared to placebo), 919 minutes for CMC ( P  = 0.117 compared to placebo) and increased by 1113 minutes for placebo. Among patients with IBS-C, there was no significant difference in change in CTT for any treatment group. One subject in the CSP01 arm developed back pain attributed to constipation and withdrew without a second CTT measurement; there were no other adverse events.
Conclusion


CSP01 significantly decreased CTT compared to placebo among patients with CIC, but not in patients with IBS-C.",2020,"In the placebo group, CTT increased by 15.3 minutes between baseline and end of treatment, increased by 366.4 minutes for CMC, and decreased by 727.4 minutes for CSP01.","['Patients With Chronic Idiopathic Constipation', 'Forty subjects (20 CSP01; 11 CMC; 9 placebo) were enrolled and 38 completed the study', 'patients with chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C) treated for 21 days with either']","['CSP01 hydrogel, active control (carboxymethylcellulose [CMC]) or placebo', 'CSP01, a Novel Superabsorbent Hydrogel', 'placebocontrolled', 'placebo']","['CTT', 'change in CTT', 'mean CTT', 'back pain', 'Colonic Transit Time', 'colonic transit time (CTT']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0267509', 'cui_str': 'Chronic idiopathic constipation'}, {'cui': 'C0065772', 'cui_str': 'MCC protocol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0063083', 'cui_str': 'Hydrogel'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0007068', 'cui_str': 'Carboxymethylcellulose'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205314', 'cui_str': 'New'}]","[{'cui': 'C0009368', 'cui_str': 'Colonic'}, {'cui': 'C1301827', 'cui_str': 'In transit'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0004604', 'cui_str': 'Backache'}]",,0.296183,"In the placebo group, CTT increased by 15.3 minutes between baseline and end of treatment, increased by 366.4 minutes for CMC, and decreased by 727.4 minutes for CSP01.","[{'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Staller', 'Affiliation': 'Division of Gastroenterology, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Barshop', 'Affiliation': 'Division of Gastroenterology, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Vélez', 'Affiliation': 'Division of Gastroenterology, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Abbey', 'Initials': 'A', 'LastName': 'Bailey', 'Affiliation': 'Division of Gastroenterology, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Joseph J', 'Initials': 'JJ', 'LastName': 'Locascio', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Chiquette', 'Affiliation': 'Gelesis Inc, Boston, MA, USA.'}, {'ForeName': 'Braden', 'Initials': 'B', 'LastName': 'Kuo', 'Affiliation': 'Division of Gastroenterology, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}]",Journal of neurogastroenterology and motility,['10.5056/jnm20001']
2469,32812025,"Evaluation of the efficacy of sofosbuvir plus daclatasvir in combination with ribavirin for hospitalized COVID-19 patients with moderate disease compared with standard care: a single-centre, randomized controlled trial.","BACKGROUND


New therapeutic options are urgently needed to tackle the novel coronavirus disease 2019 (COVID-19). Repurposing existing pharmaceuticals provides an immediate treatment opportunity. We assessed the efficacy of sofosbuvir and daclatasvir with ribavirin for treating patients with COVID-19.
METHODS


This was a single-centre, randomized controlled trial in adults with moderate COVID-19 admitted to the Ghaem Shahr Razi Hospital in Mazandaran Province, Iran. Patients were randomly assigned to 400 mg sofosbuvir, 60 mg daclatasvir and 1200 mg ribavirin (intervention group) or to standard care (control group). The primary endpoint of this study was length of hospital stay. This study is registered by IRCT.ir under the ID: IRCT20200328046886N1.
RESULTS


Between 20 March 2020 and 8 April 2020, 48 patients were recruited; 24 patients were randomly assigned to the intervention group and 24 to the control group. The median duration of hospital stay was 6 days in both groups (P = 0.398). The number of ICU admissions in the sofosbuvir/daclatasvir/ribavirin group was not significantly lower than the control group (0 versus 4, P = 0.109). There was no difference in the number of deaths between the groups (0 versus 3, P = 0.234). The cumulative incidence of recovery was higher in the sofosbuvir/daclatasvir/ribavirin arm (Gray's P = 0.033).
CONCLUSIONS


This randomized trial was too small to make definitive conclusions. There were trends in favour of the sofosbuvir/daclatasvir/ribavirin arm for recovery and lower death rates. However, there was an imbalance in the baseline characteristics between the arms. Larger randomized trials should be conducted to investigate this treatment further.",2020,"There was no difference in the number of deaths between the groups (0 versus 3, P = 0.234).","['adults with moderate COVID-19 admitted to the Ghaem Shahr Razi Hospital in Mazandaran Province, Iran', 'hospitalized COVID-19 patients with moderate disease compared with standard care', 'treating patients with COVID-19', 'Between 20 March 2020 and 8 April 2020, 48 patients were recruited; 24 patients']","['sofosbuvir plus daclatasvir', 'daclatasvir and 1200\u2009mg ribavirin (intervention group) or to standard care (control group', 'ribavirin']","['median duration of hospital stay', 'recovery and lower death rates', 'number of ICU admissions', 'length of hospital stay', 'number of deaths', 'cumulative incidence of recovery']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C2976303', 'cui_str': 'sofosbuvir'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C3252090', 'cui_str': 'daclatasvir'}, {'cui': 'C4517548', 'cui_str': '1200'}, {'cui': 'C0035525', 'cui_str': 'Ribavirin'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",48.0,0.112652,"There was no difference in the number of deaths between the groups (0 versus 3, P = 0.234).","[{'ForeName': 'Hamideh', 'Initials': 'H', 'LastName': 'Abbaspour Kasgari', 'Affiliation': 'Department of Clinical Pharmacy, School of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Siavash', 'Initials': 'S', 'LastName': 'Moradi', 'Affiliation': 'Education Development Center, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Amir Mohammad', 'Initials': 'AM', 'LastName': 'Shabani', 'Affiliation': 'Department of Clinical Pharmacy, School of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Farhang', 'Initials': 'F', 'LastName': 'Babamahmoodi', 'Affiliation': 'Antimicrobial Resistance Research Center, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Ali Reza', 'Initials': 'AR', 'LastName': 'Davoudi Badabi', 'Affiliation': 'Antimicrobial Resistance Research Center, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Lotfollah', 'Initials': 'L', 'LastName': 'Davoudi', 'Affiliation': 'Antimicrobial Resistance Research Center, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Alikhani', 'Affiliation': 'Antimicrobial Resistance Research Center, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Akbar', 'Initials': 'A', 'LastName': 'Hedayatizadeh Omran', 'Affiliation': 'Gastrointestinal Cancer Research Center, Cancer Research Institute, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Saeedi', 'Affiliation': 'Pharmaceutical Sciences Research Center, Hemoglobinopathy Research Institute, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Shahin', 'Initials': 'S', 'LastName': 'Merat', 'Affiliation': 'Liver and Pancreatobiliary Diseases Research Center, Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Wentzel', 'Affiliation': 'School of Public Health, Imperial College London, London, UK.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Garratt', 'Affiliation': 'Cardiff and Vale University Health Board, Cardiff, UK.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Levi', 'Affiliation': 'Accident and Emergency Department, Homerton University Hospital NHS Trust, London, UK.'}, {'ForeName': 'Bryony', 'Initials': 'B', 'LastName': 'Simmons', 'Affiliation': 'Department of Infectious Disease, Imperial College London, London, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Hill', 'Affiliation': 'Department of Translational Medicine, University of Liverpool, UK.'}, {'ForeName': 'Hafez', 'Initials': 'H', 'LastName': 'Tirgar Fakheri', 'Affiliation': 'Gut and Liver Research Center, Mazandaran University of Medical Sciences, Sari, Iran.'}]",The Journal of antimicrobial chemotherapy,['10.1093/jac/dkaa332']
2470,32812039,Sofosbuvir and daclatasvir compared with standard of care in the treatment of patients admitted to hospital with moderate or severe coronavirus infection (COVID-19): a randomized controlled trial.,"BACKGROUND


Currently no effective antiviral therapy has been found to treat COVID-19. The aim of this trial was to assess if the addition of sofosbuvir and daclatasvir improved clinical outcomes in patients with moderate or severe COVID-19.
METHODS


This was an open-label, multicentre, randomized controlled clinical trial in adults with moderate or severe COVID-19 admitted to four university hospitals in Iran. Patients were randomized into a treatment arm receiving sofosbuvir and daclatasvir plus standard care, or a control arm receiving standard care alone. The primary endpoint was clinical recovery within 14 days of treatment. The study is registered with IRCT.ir under registration number IRCT20200128046294N2.
RESULTS


Between 26 March and 26 April 2020, 66 patients were recruited and allocated to either the treatment arm (n = 33) or the control arm (n = 33). Clinical recovery within 14 days was achieved by 29/33 (88%) in the treatment arm and 22/33 (67%) in the control arm (P = 0.076). The treatment arm had a significantly shorter median duration of hospitalization [6 days (IQR 4-8)] than the control group [8 days (IQR 5-13)]; P = 0.029. Cumulative incidence of hospital discharge was significantly higher in the treatment arm versus the control (Gray's P = 0.041). Three patients died in the treatment arm and five in the control arm. No serious adverse events were reported.
CONCLUSIONS


The addition of sofosbuvir and daclatasvir to standard care significantly reduced the duration of hospital stay compared with standard care alone. Although fewer deaths were observed in the treatment arm, this was not statistically significant. Conducting larger scale trials seems prudent.",2020,The addition of sofosbuvir and daclatasvir to standard care significantly reduced the duration of hospital stay compared with standard care alone.,"['adults with moderate or severe COVID-19 admitted to four university hospitals in Iran', 'patients admitted to hospital with moderate or severe coronavirus infection (COVID-19', '66 patients', 'Between 26 March and 26 April 2020', 'patients with moderate or severe COVID-19']","['sofosbuvir and daclatasvir plus standard care, or a control arm receiving standard care alone', 'Sofosbuvir and daclatasvir']","['median duration of hospitalization', 'duration of hospital stay', 'Clinical recovery', 'serious adverse events', 'deaths', 'clinical recovery', 'Cumulative incidence of hospital discharge']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206750', 'cui_str': 'Coronavirus infection'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C2976303', 'cui_str': 'sofosbuvir'}, {'cui': 'C3252090', 'cui_str': 'daclatasvir'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}]",66.0,0.111872,The addition of sofosbuvir and daclatasvir to standard care significantly reduced the duration of hospital stay compared with standard care alone.,"[{'ForeName': 'Anahita', 'Initials': 'A', 'LastName': 'Sadeghi', 'Affiliation': 'Liver and Pancreatobiliary Diseases Research Center, Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Ali Asgari', 'Affiliation': 'Liver and Pancreatobiliary Diseases Research Center, Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Norouzi', 'Affiliation': 'Golestan Research Center of Gastroenterology and Hepatology, Golestan University of Medical Science, Gorgan, Iran.'}, {'ForeName': 'Zahedin', 'Initials': 'Z', 'LastName': 'Kheiri', 'Affiliation': 'Department of Internal Medicine, Baharloo hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Anushirvani', 'Affiliation': 'Liver and Pancreatobiliary Diseases Research Center, Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mahnaz', 'Initials': 'M', 'LastName': 'Montazeri', 'Affiliation': 'Department of infectious diseases, Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hadiseh', 'Initials': 'H', 'LastName': 'Hosamirudsai', 'Affiliation': 'Department of Infectious Diseases, Baharloo Hospital, Tehran University of Medical Science, Tehran, Iran.'}, {'ForeName': 'Shirin', 'Initials': 'S', 'LastName': 'Afhami', 'Affiliation': 'Department of infectious diseases, Shariati Hospital, Tehran University of Medical Science, Tehran, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Akbarpour', 'Affiliation': 'Liver and Pancreatobiliary Diseases Research Center, Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Rasoul', 'Initials': 'R', 'LastName': 'Aliannejad', 'Affiliation': 'Department of Pulmonary and Critical Care, Shariati Hospital, Thoracic Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Amir Reza', 'Initials': 'AR', 'LastName': 'Radmard', 'Affiliation': 'Department of Radiology, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Amir H', 'Initials': 'AH', 'LastName': 'Davarpanah', 'Affiliation': 'Department of Radiology and Imaging Sciences, Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Levi', 'Affiliation': 'Department of Emergency Medicine, Homerton University Hospital, London, UK.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Wentzel', 'Affiliation': 'School of Public Health, Imperial College London, London, UK.'}, {'ForeName': 'Ambar', 'Initials': 'A', 'LastName': 'Qavi', 'Affiliation': 'School of Public Health, Imperial College London, London, UK.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Garratt', 'Affiliation': 'Cardiff and Vale University Health Board, Cardiff, UK.'}, {'ForeName': 'Bryony', 'Initials': 'B', 'LastName': 'Simmons', 'Affiliation': 'Department of Infectious Disease, Imperial College London, London, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Hill', 'Affiliation': 'Department of Pharmacology and Therapeutics, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Shahin', 'Initials': 'S', 'LastName': 'Merat', 'Affiliation': 'Liver and Pancreatobiliary Diseases Research Center, Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran.'}]",The Journal of antimicrobial chemotherapy,['10.1093/jac/dkaa334']
2471,32821954,[Randomized controlled trial for palliative radiotherapy of head and neck cancer-challenges remain].,,2020,,[],['palliative radiotherapy'],[],[],"[{'cui': 'C0587605', 'cui_str': 'Palliative care service'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]",[],,0.116873,,"[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Fabian', 'Affiliation': 'Klinik für Strahlentherapie, Universitätsklinikum Schleswig-Holstein (UKSH), Campus Kiel, Arnold-Heller-Str.\xa03, 24105, Kiel, Deutschland. alexander.fabian@uksh.de.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Krug', 'Affiliation': 'Klinik für Strahlentherapie, Universitätsklinikum Schleswig-Holstein (UKSH), Campus Kiel, Arnold-Heller-Str.\xa03, 24105, Kiel, Deutschland.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Dunst', 'Affiliation': 'Klinik für Strahlentherapie, Universitätsklinikum Schleswig-Holstein (UKSH), Campus Kiel, Arnold-Heller-Str.\xa03, 24105, Kiel, Deutschland.'}]",Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al],['10.1007/s00066-020-01672-2']
2472,32822775,Tocilizumab improves oxidative stress and endothelial glycocalyx: A mechanism that may explain the effects of biological treatment on COVID-19.,"We investigated the effects of tocilizumab on endothelial glycocalyx, a determinant of vascular permeability, and myocardial function in rheumatoid arthritis (RA). Eighty RA patients were randomized to tocilizumab (n = 40) or conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) and glucocorticoids (GC) (n = 40) for 3 months. Forty healthy subjects with similar age and sex served as controls. We measured: (a)perfused boundary region (PBR) of the sublingual arterial microvessels (increased PBR indicates reduced glycocalyx thickness), (b)pulse wave velocity (PWV), (c)global LV longitudinal strain (GLS), (d)global work index (GWI) using speckle tracking echocardiography and e)C-reactive protein (CRP), malondialdehyde (MDA) and protein carbonyls (PCs) as oxidative stress markers at baseline and post-treatment. Compared to controls, RA patients had impaired glycocalyx and myocardial deformation markers (P < 0.05). Compared with baseline, tocilizumab reduced PBR(2.14 ± 0.2 versus 1.97 ± 0.2 μm; P < 0.05) while no significant differences were observed post-csDMARDs + GC(P > 0.05). Compared with csDMARDs + GC, tocilizumab achieved a greater increase of GLS, GWI and reduction of MDA, PCs and CRP(P < 0.05). The percent improvement of glycocalyx thickness (PBR) was associated with the percent decrease of PWV, MDA, PCs and the percent improvement of GLS and GWI(P < 0.05). Tocilizumab improves endothelial function leading to a greater increase of effective myocardial work than csDMARDs + GC through a profound reduction of inflammatory burden and oxidative stress. This mechanism may explain the effects of tocilizumab on COVID-19. CLINICAL TRIAL REGISTRATION: url: https://www.clinicaltrials.gov. Unique identifier: NCT03288584.",2020,"Compared to controls, RA patients had impaired glycocalyx and myocardial deformation markers(P<0.05).","['Eighty RA patients', 'Forty healthy subjects with similar age and sex served as controls', 'rheumatoid arthritis(RA']","['csDMARDs+GC', 'tocilizumab', 'csDMARDs+GC, tocilizumab', 'Tocilizumab', 'tocilizumab(n=40) or conventional synthetic disease-modifying antirheumatic drugs(csDMARDs) and glucocorticoids(GC']","['glycocalyx thickness), b)pulse wave velocity(PWV), c)global LV longitudinal strain(GLS), d)global work index(GWI) using speckle tracking echocardiography and e)C-reactive protein(CRP), malondialdehyde(MDA) and protein carbonyls(PCs) as oxidative stress markers', 'PWV, MDA, PCs and the percent improvement of GLS and GWI(P<0.05', 'oxidative stress and endothelial glycocalyx', 'glycocalyx thickness(PBR', 'GLS, GWI and reduction of MDA, PCs and CRP(P<0.05']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1609165', 'cui_str': 'tocilizumab'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0242708', 'cui_str': 'Disease-Modifying Antirheumatic Drugs'}]","[{'cui': 'C0061622', 'cui_str': 'Glycocalyx'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439691', 'cui_str': 'Speckled'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0000379', 'cui_str': 'Methylenedioxyamphetamine'}, {'cui': 'C1882368', 'cui_str': 'Dynamic Light Scattering'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0017767', 'cui_str': 'Glucosinolate'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",80.0,0.0830911,"Compared to controls, RA patients had impaired glycocalyx and myocardial deformation markers(P<0.05).","[{'ForeName': 'Ignatios', 'Initials': 'I', 'LastName': 'Ikonomidis', 'Affiliation': '2nd Department of Cardiology, Attikon Hospital, National and Kapodistrian University of Athens, Medical School, 12462, Athens, Greece. Electronic address: ignoik@gmail.com.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Pavlidis', 'Affiliation': '2nd Department of Cardiology, Attikon Hospital, National and Kapodistrian University of Athens, Medical School, 12462, Athens, Greece.'}, {'ForeName': 'Pelagia', 'Initials': 'P', 'LastName': 'Katsimbri', 'Affiliation': '4th Department of Internal Medicine, Attikon Hospital, National and Kapodistrian University of Athens, Medical School, 12462, Athens, Greece.'}, {'ForeName': 'Vaia', 'Initials': 'V', 'LastName': 'Lambadiari', 'Affiliation': '2nd Department of Internal Medicine, Research Unit and Diabetes Center, Attikon Hospital, National and Kapodistrian University of Athens, Medical School, 12462, Athens, Greece.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Parissis', 'Affiliation': '2nd Department of Cardiology, Attikon Hospital, National and Kapodistrian University of Athens, Medical School, 12462, Athens, Greece.'}, {'ForeName': 'Ioanna', 'Initials': 'I', 'LastName': 'Andreadou', 'Affiliation': 'Laboratory of Pharmacology, Faculty of Pharmacy, National and Kapodistrian University of Athens, 15741, Athens, Greece.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Tsoumani', 'Affiliation': 'Laboratory of Pharmacology, Faculty of Pharmacy, National and Kapodistrian University of Athens, 15741, Athens, Greece.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Boumpas', 'Affiliation': '4th Department of Internal Medicine, Attikon Hospital, National and Kapodistrian University of Athens, Medical School, 12462, Athens, Greece.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Kouretas', 'Affiliation': 'Department of Biochemistry and Biotechnology, University of Thessaly, 41500, Larissa, Greece.'}, {'ForeName': 'Efstathios', 'Initials': 'E', 'LastName': 'Iliodromitis', 'Affiliation': '2nd Department of Cardiology, Attikon Hospital, National and Kapodistrian University of Athens, Medical School, 12462, Athens, Greece.'}]",Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association,['10.1016/j.fct.2020.111694']
2473,32838673,Systolic Blood Pressure Reduction and Acute Kidney Injury in Intracerebral Hemorrhage.,"BACKGROUND AND PURPOSE


We determined the rates and predictors of acute kidney injury (AKI) and renal adverse events (AEs), and effects of AKI and renal AEs on death or disability in patients with intracerebral hemorrhage.
METHODS


We analyzed data from a multicenter trial which randomized 1000 intracerebral hemorrhage patients with initial systolic blood pressure ≥180 mm Hg to intensive (goal 110-139 mm Hg) over standard (goal 140-179 mm Hg) systolic blood pressure reduction within 4.5 hours of symptom onset. AKI was identified by serial assessment of daily serum creatinine for 3 days post randomization.
RESULTS


AKI and renal AEs were observed in 149 patients (14.9%) and 65 patients (6.5%) among 1000 patients, respectively. In multivariate analysis, the higher baseline serum creatinine (≥110 μmol/L) was associated with AKI (odds ratio 2.4 [95% CI, 1.2-4.5]) and renal AEs (odds ratio 3.1 [95% CI, 1.2-8.1]). Higher area under the curve for intravenous nicardipine dose was associated with AKI (odds ratio 1.003 [95% CI, 1.001-1.005]) and renal AEs (odds ratio 1.003 [95% CI, 1.001-1.006]). There was a higher risk to death (relative risk 2.6 [95% CI, 1.6-4.2]) and death or disability (relative risk 1.5 [95% CI, 1.3-1.8]) at 90 days in patients with AKI but not in those with renal AEs.
CONCLUSIONS


Intracerebral hemorrhage patients with higher baseline serum creatinine and those receiving higher doses of nicardipine were at higher risk for AKI and renal AEs. Occurrence of AKI was associated higher rates of death or disability at 3 months. Registration: URL: https://clinicaltrials.gov. Unique identifier: NCT01176565.",2020,"There was a higher risk to death (relative risk 2.6 [95% CI, 1.6-4.2]) and death or disability (relative risk 1.5 [95% CI, 1.3-1.8]) at 90 days in patients with AKI but not in those with renal AEs.
","['patients with intracerebral hemorrhage', 'Intracerebral Hemorrhage', '1000 intracerebral hemorrhage patients with initial systolic blood pressure ≥180 mm', '110-139 mm Hg) over standard (goal 140-179 mm']",['nicardipine'],"['higher baseline serum creatinine', 'death or disability', 'Hg) systolic blood pressure reduction', 'Systolic Blood Pressure Reduction and Acute Kidney Injury', 'renal AEs', 'risk to death', 'AKI and renal AEs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C4517609', 'cui_str': '179'}]","[{'cui': 'C0028005', 'cui_str': 'Nicardipine'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",1000.0,0.543091,"There was a higher risk to death (relative risk 2.6 [95% CI, 1.6-4.2]) and death or disability (relative risk 1.5 [95% CI, 1.3-1.8]) at 90 days in patients with AKI but not in those with renal AEs.
","[{'ForeName': 'Adnan I', 'Initials': 'AI', 'LastName': 'Qureshi', 'Affiliation': 'Zeenat Qureshi Stroke Institute, and Department of Neurology, University of Missouri-Columbia (A.I.Q., W.H., I.L.).'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Huang', 'Affiliation': 'Zeenat Qureshi Stroke Institute, and Department of Neurology, University of Missouri-Columbia (A.I.Q., W.H., I.L.).'}, {'ForeName': 'Iryna', 'Initials': 'I', 'LastName': 'Lobanova', 'Affiliation': 'Zeenat Qureshi Stroke Institute, and Department of Neurology, University of Missouri-Columbia (A.I.Q., W.H., I.L.).'}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'Hanley', 'Affiliation': 'The Neurology Department of Johns Hopkins University, Baltimore, MD (D.F.H.).'}, {'ForeName': 'Chung Y', 'Initials': 'CY', 'LastName': 'Hsu', 'Affiliation': 'Graduate Institute of Clinical Medical Science, China Medical University, Taichung, Taiwan (C.Y.H.).'}, {'ForeName': 'Kunal', 'Initials': 'K', 'LastName': 'Malhotra', 'Affiliation': 'Department of Nephrology, University of Missouri-Columbia. (K.M.).'}, {'ForeName': 'Thorsten', 'Initials': 'T', 'LastName': 'Steiner', 'Affiliation': 'Department of Neurology, Klinikum Frankfurt Höchst, Germany (T.S.).'}, {'ForeName': 'Jose I', 'Initials': 'JI', 'LastName': 'Suarez', 'Affiliation': 'Division of Neurosciences Critical Care, The Johns Hopkins University School of Medicine, Baltimore, MD (J.I.S.).'}, {'ForeName': 'Kazunori', 'Initials': 'K', 'LastName': 'Toyoda', 'Affiliation': 'Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Japan. (K.T.).'}, {'ForeName': 'Haruko', 'Initials': 'H', 'LastName': 'Yamamoto', 'Affiliation': 'Center for Advancing Clinical and Translational Sciences, National Cerebral and Cardiovascular Center, Suita, Japan. (H.Y.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Stroke,['10.1161/STROKEAHA.120.030272']
2474,32783799,Baseline Characteristics of Study Participants in the Early Life Interventions for Childhood Growth and Development in Tanzania (ELICIT) Trial.,"Recurrent enteric infections and micronutrient deficiencies, including deficiencies in the tryptophan-kynurenine-niacin pathway, have been associated with environmental enteric dysfunction, potentially contributing to poor child growth and development. We are conducting a randomized, placebo-controlled, 2 × 2 factorial interventional trial in a rural population in Haydom, Tanzania, to determine the effect of 1) antimicrobials (azithromycin and nitazoxanide) and/or 2) nicotinamide, a niacin vitamer, on attained length at 18 months. Mother/infant dyads were enrolled within 14 days of the infant's birth from September 2017 to September 2018, with the follow-up to be completed in February 2020. Here, we describe the baseline characteristics of the study cohort, risk factors for low enrollment weight, and neonatal adverse events (AEs). Risk factors for a low enrollment weight included being a firstborn child (-0.54 difference in weight-for-age  z -score [WAZ] versus other children, 95% CI: -0.71, -0.37), lower socioeconomic status (-0.28, 95% CI: -0.43, -0.12 difference in WAZ), and birth during the preharvest season (November to March) (-0.22, 95% CI: -0.33, -0.11 difference in WAZ). The most common neonatal serious AEs were respiratory tract infections and neonatal sepsis (2.2 and 1.4 events per 100 child-months, respectively). The study cohort represents a high-risk population for whom interventions to improve child growth and development are urgently needed. Further analyses are needed to understand the persistent impacts of seasonal malnutrition and the interactions between seasonality, socioeconomic status, and the study interventions.",2020,"The most common neonatal serious AEs were respiratory tract infections and neonatal sepsis (2.2 and 1.4 events per 100 child-months, respectively).","[""Mother/infant dyads were enrolled within 14 days of the infant's birth from September 2017 to September 2018, with the follow-up to be completed in February 2020"", 'rural population in Haydom, Tanzania', 'Study Participants in the Early Life Interventions for Childhood Growth and Development in Tanzania (ELICIT) Trial']","['antimicrobials (azithromycin and nitazoxanide) and/or 2) nicotinamide, a niacin vitamer', 'placebo']","['lower socioeconomic status', 'respiratory tract infections and neonatal sepsis']","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0035962', 'cui_str': 'Rural Population'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0068788', 'cui_str': 'nitazoxanide'}, {'cui': 'C0028027', 'cui_str': 'Niacinamide'}, {'cui': 'C0027996', 'cui_str': 'Niacin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0086996', 'cui_str': 'Socioeconomic Status'}, {'cui': 'C0035243', 'cui_str': 'Respiratory tract infection'}, {'cui': 'C0456103', 'cui_str': 'Sepsis of the newborn'}]",,0.15935,"The most common neonatal serious AEs were respiratory tract infections and neonatal sepsis (2.2 and 1.4 events per 100 child-months, respectively).","[{'ForeName': 'Tarina C', 'Initials': 'TC', 'LastName': 'Parpia', 'Affiliation': 'Division of Infectious Diseases and International Health, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Elwood', 'Affiliation': 'Division of Infectious Diseases and International Health, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Rebecca J', 'Initials': 'RJ', 'LastName': 'Scharf', 'Affiliation': 'Department of Pediatrics, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Joann M', 'Initials': 'JM', 'LastName': 'McDermid', 'Affiliation': 'Division of Infectious Diseases and International Health, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Anne W', 'Initials': 'AW', 'LastName': 'Wanjuhi', 'Affiliation': 'Department of Pediatrics, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Elizabeth T', 'Initials': 'ET', 'LastName': 'Rogawski McQuade', 'Affiliation': 'Division of Infectious Diseases and International Health, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Gratz', 'Affiliation': 'Division of Infectious Diseases and International Health, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Erling', 'Initials': 'E', 'LastName': 'Svensen', 'Affiliation': 'Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Jonathan R', 'Initials': 'JR', 'LastName': 'Swann', 'Affiliation': 'School of Human Development and Health, Faculty of Medicine, University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'Donowitz', 'Affiliation': ""Division of Infectious Disease, Children's Hospital of Richmond at Virginia Commonwealth University, Richmond, Virginia.""}, {'ForeName': 'Samwel', 'Initials': 'S', 'LastName': 'Jatosh', 'Affiliation': 'Haydom Global Health Research Centre, Haydom Lutheran Hospital, Haydom, Tanzania.'}, {'ForeName': 'Siphael', 'Initials': 'S', 'LastName': 'Katengu', 'Affiliation': 'Haydom Global Health Research Centre, Haydom Lutheran Hospital, Haydom, Tanzania.'}, {'ForeName': 'Paschal', 'Initials': 'P', 'LastName': 'Mdoe', 'Affiliation': 'Haydom Global Health Research Centre, Haydom Lutheran Hospital, Haydom, Tanzania.'}, {'ForeName': 'Sokoine', 'Initials': 'S', 'LastName': 'Kivuyo', 'Affiliation': 'National Institute for Medical Research, Muhimbili Medical Research Centre, Dar es Salaam, Tanzania.'}, {'ForeName': 'Eric R', 'Initials': 'ER', 'LastName': 'Houpt', 'Affiliation': 'Division of Infectious Diseases and International Health, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'DeBoer', 'Affiliation': 'Department of Pediatrics, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Estomih', 'Initials': 'E', 'LastName': 'Mduma', 'Affiliation': 'Haydom Global Health Research Centre, Haydom Lutheran Hospital, Haydom, Tanzania.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Platts-Mills', 'Affiliation': 'Division of Infectious Diseases and International Health, University of Virginia, Charlottesville, Virginia.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0918']
2475,32786112,Is pelvic floor muscle training able to alter the response of cardiovascular autonomic modulation and provide a possible cardiovascular benefit to pregnant women?,"AIMS


To evaluate the acute and chronic effect of an exercise protocol of pelvic floor muscles (PFMs) contraction on the heart period (HP) and systolic arterial pressure (SAP) variabilities and baroreflex sensitivity (BRS) at rest in pregnant women; and to evaluate if this progressive exercise protocol was well-tolerated by the pregnant women studied.
METHODS


We evaluated 48 women at 18 weeks of pregnancy by vaginal palpation, vaginal manometry, and cardiopulmonary exercise test. They were divided in control (CG; 31.75 ± 3.91 years) and training groups (TG; 30.71 ± 3.94 years). At 19 and 36 weeks of pregnancy, electrocardiogram and noninvasive peripheral SAP data were collected at rest before and after 10 PFM contractions. TG performed PFMT from the 20th to the 36th week. HP and SAP variabilities were analyzed by spectral and symbolic analysis. The baroreflex was evaluated by cross-spectral analysis between the HP and SAP series.
RESULTS


The groups did not differ in relation to VO 2  , HP and SAP variabilities, and BRS at the beginning of the protocol. TG increased the endurance of the PFM after training. PFM contraction did not change the HP and SAP variabilities, and BRS at the 18th week. After the training, the TG presented lower SAP mean, lower BF of SAP variability, and higher BRS than CG.
CONCLUSIONS


Acute PFM contractions did not alter HP and SAP variabilities and BRS, but PFMT resulted in a lower SAP mean and higher BRS in trained pregnant when compared to the untrained.",2020,"After the training, the TG presented lower SAP mean, lower BF of SAP variability, and higher BRS than CG.
","['pregnant women studied', '48 women at 18\u2009weeks of pregnancy by vaginal palpation, vaginal manometry, and cardiopulmonary exercise test', 'pregnant women']","['progressive exercise protocol', 'exercise protocol of pelvic floor muscles (PFMs) contraction']","['HP and SAP variabilities, and BRS', 'pregnancy, electrocardiogram and noninvasive peripheral SAP data', 'relation to VO 2  , HP and SAP variabilities, and BRS', 'HP and SAP variabilities', 'heart period (HP) and systolic arterial pressure (SAP) variabilities and baroreflex sensitivity (BRS', 'HP and SAP variabilities and BRS', 'SAP mean and higher BRS', 'PFM contraction', 'SAP mean, lower BF of SAP variability']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0030247', 'cui_str': 'Palpation'}, {'cui': 'C0024751', 'cui_str': 'Manometry'}, {'cui': 'C2959886', 'cui_str': 'Cardiopulmonary exercise test'}]","[{'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}]","[{'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0206162', 'cui_str': 'Baroreceptor reflex'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1868598', 'cui_str': 'Enlarged parietal foramina'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",48.0,0.0360243,"After the training, the TG presented lower SAP mean, lower BF of SAP variability, and higher BRS than CG.
","[{'ForeName': 'Mikaela', 'Initials': 'M', 'LastName': 'da Silva Corrêa', 'Affiliation': ""Women's Health Research Laboratory, Physical Therapy Department, Rodovia Washington Luís, km 235, Monjolinho, São Carlos, São Paulo, Brazil.""}, {'ForeName': 'Aparecida M', 'Initials': 'AM', 'LastName': 'Catai', 'Affiliation': 'Cardiovascular Physiotherapy Laboratory, Physical Therapy Department, Rodovia Washington Luís, km 235, Monjolinho, São Carlos, São Paulo, Brazil.'}, {'ForeName': 'Juliana C', 'Initials': 'JC', 'LastName': 'Milan-Mattos', 'Affiliation': 'Cardiovascular Physiotherapy Laboratory, Physical Therapy Department, Rodovia Washington Luís, km 235, Monjolinho, São Carlos, São Paulo, Brazil.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Porta', 'Affiliation': 'Department of Biomedical Sciences for Health, University of Milan, Milan, Italy.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Driusso', 'Affiliation': ""Women's Health Research Laboratory, Physical Therapy Department, Rodovia Washington Luís, km 235, Monjolinho, São Carlos, São Paulo, Brazil.""}]",Neurourology and urodynamics,['10.1002/nau.24481']
2476,32794334,Prognostic value of MRI-determined cervical lymph node size in nasopharyngeal carcinoma.,"OBJECTIVES


To investigate the prognostic value of magnetic resonance imaging (MRI)-determined cervical lymph node (CLN) size in nasopharyngeal carcinoma (NPC).
METHODS


We retrospectively reviewed 2066 patients with NPC treated with intensity-modulated radiotherapy, and randomly divided them into two groups, in a 1:1 ratio. One group was used for training (the training group), and the other one was for internal validation (the validation group). All patients had undergone MRI examination and the maximal axial diameters (MAD) of the axial plane of all positive nodes had been measured and recorded.
RESULTS


Of 683 patients with CLN metastases in the training group (n = 1033), MAD = 4 cm was associated with worse OS (64.7% vs 84.6%, P < .001), DFS (55.9% vs 76.3%, P = .001), and DMFS (67.6% vs 86.1%, P = .001). Multivariate analysis showed that MAD = 4 cm was a significant negative prognostic factor for OS (HR = 2.058; P = .025), DFS (HR = 1.727; P = .049), and DMFS (HR = 2.034; P = .036). When MRI-determined MAD = 4 cm was classified as N3 in the N classification, the OS, DFS, DMFS, and RRFS survival curves were well separated. The OS, DFS, DMFS, and RRFS concordance indexes were not statistically different between the proposed N staging system and the UICC/AJCC staging system in the training group, or between the training group and the validation group (all P = .05).
CONCLUSION


MAD = 4 cm on axial MRI slices can be recommended as a prognostic factor in future versions of the UICC/AJCC NPC staging system.",2020,"The OS, DFS, DMFS, and RRFS concordance indexes were not statistically different between the proposed N staging system and the UICC/AJCC staging system in the training group, or between the training group and the validation group (all P = .05).
","['683 patients with CLN metastases in the training group (n\xa0=\xa01033', '2066 patients with NPC treated with intensity-modulated', 'nasopharyngeal carcinoma', 'nasopharyngeal carcinoma (NPC']","['radiotherapy', 'magnetic resonance imaging (MRI)-determined cervical lymph node (CLN']","['DFS', 'undergone MRI examination and the maximal axial diameters (MAD', 'DMFS', 'OS, DFS, DMFS, and RRFS concordance indexes', 'worse OS', 'OS, DFS, DMFS, and RRFS survival curves']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0588054', 'cui_str': 'Cervical lymph node group'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C2931822', 'cui_str': 'Nasopharyngeal carcinoma'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0588054', 'cui_str': 'Cervical lymph node group'}]","[{'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0205131', 'cui_str': 'Axial'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0254792', 'cui_str': 'ribosome releasing factor'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205134', 'cui_str': 'Curved'}]",2066.0,0.0325976,"The OS, DFS, DMFS, and RRFS concordance indexes were not statistically different between the proposed N staging system and the UICC/AJCC staging system in the training group, or between the training group and the validation group (all P = .05).
","[{'ForeName': 'Cheng-Long', 'Initials': 'CL', 'LastName': 'Huang', 'Affiliation': 'Department of Radiation Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Radiation Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Guo', 'Affiliation': 'Department of Radiation Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Yan-Ping', 'Initials': 'YP', 'LastName': 'Mao', 'Affiliation': 'Department of Radiation Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Xu', 'Affiliation': 'Department of Radiation Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Tian', 'Affiliation': 'Imaging Diagnosis and Interventional Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Li-Zhi', 'Initials': 'LZ', 'LastName': 'Liu', 'Affiliation': 'Imaging Diagnosis and Interventional Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Ai-Hua', 'Initials': 'AH', 'LastName': 'Lin', 'Affiliation': 'Department of Medical Statistics and Epidemiology, School of Public Health, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Department of Radiation Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Department of Radiation Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Ling-Long', 'Initials': 'LL', 'LastName': 'Tang', 'Affiliation': 'Department of Radiation Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou, China.'}]",Cancer medicine,['10.1002/cam4.3392']
2477,32795597,Racial disparities in out-of-hospital cardiac arrest interventions and survival in the Pragmatic Airway Resuscitation Trial.,"BACKGROUND


Prior studies have reported racial disparities in survival from out-of-hospital cardiac arrest (OHCA). However, these studies did not evaluate the association of race with OHCA course of care and outcomes. The purpose of this study was to evaluate racial disparities in OHCA airway placement success and patient outcomes in the multicenter Pragmatic Airway Resuscitation Trial (PART).
METHOD


We conducted a secondary analysis of adult OHCA patients enrolled in PART. The parent trial randomized subjects to initial advanced airway management with laryngeal tube or endotracheal intubation. For this analysis, the primary independent variable was patient race categorized by emergency medical services (EMS) as white, black, Hispanic, other, and unknown. We used general estimating equations to examine the association of race with airway attempt success, 72-h survival, and survival to hospital discharge, adjusting for sex, age, witness status, bystander cardiopulmonary resuscitation (CPR), initial rhythm, arrest location, and PART randomization cluster.
RESULTS


Of 3002 patients, EMS-assessed race as 1537 white, 860 black, 163 Hispanic, 90 other, and 352 unknown. Initial shockable rhythms (13.8% vs. 21.5%, p < 0.001), bystander CPR (35.6% vs. 51.4%, p < 0.001), and survival to hospital discharge (7.6% vs. 10.8%, p = 0.011) were lower for black compared to white patients. After adjustment for confounders, no difference was seen in airway success, 72-h survival, and survival to hospital discharge by race.
CONCLUSIONS


In one of the largest studies evaluating differences in prehospital airway interventions and outcomes by EMS-assessed race for OHCA patients, we found no significant adjusted differences between airway success or survival outcomes.",2020,"After adjustment for confounders, no difference was seen in airway success, 72-h survival, and survival to hospital discharge by race.
","[' EMS-assessed race as 1537 white, 860 black, 163 Hispanic, 90 other, and 352 unknown', '3002 patients', 'adult OHCA patients enrolled in PART']",['initial advanced airway management with laryngeal tube or endotracheal intubation'],"['association of race with airway attempt success, 72-h survival, and survival to hospital discharge, adjusting for sex, age, witness status, bystander cardiopulmonary resuscitation (CPR), initial rhythm, arrest location, and PART randomization cluster', 'airway success, 72-h survival, and survival to hospital discharge by race', 'Initial shockable rhythms', 'survival to hospital discharge', 'bystander CPR', 'airway success or survival outcomes']","[{'cui': 'C0013961', 'cui_str': 'Emergency medical services'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0150126', 'cui_str': 'Airway management'}, {'cui': 'C0023078', 'cui_str': 'Laryngeal'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}]","[{'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",3002.0,0.089249,"After adjustment for confounders, no difference was seen in airway success, 72-h survival, and survival to hospital discharge by race.
","[{'ForeName': 'Joshua R', 'Initials': 'JR', 'LastName': 'Lupton', 'Affiliation': 'Oregon Health & Science University, United States. Electronic address: lupton@ohsu.edu.'}, {'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Schmicker', 'Affiliation': 'University of Washington School of Medicine, United States.'}, {'ForeName': 'Tom P', 'Initials': 'TP', 'LastName': 'Aufderheide', 'Affiliation': 'Medical College of Wisconsin, United States.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Blewer', 'Affiliation': 'Duke University School of Medicine, United States.'}, {'ForeName': 'Clifton', 'Initials': 'C', 'LastName': 'Callaway', 'Affiliation': 'University of Pittsburgh School of Medicine, United States.'}, {'ForeName': 'Jestin N', 'Initials': 'JN', 'LastName': 'Carlson', 'Affiliation': 'Allegheny Health Network, United States.'}, {'ForeName': 'M Riccardo', 'Initials': 'MR', 'LastName': 'Colella', 'Affiliation': 'Medical College of Wisconsin, United States.'}, {'ForeName': 'Matt', 'Initials': 'M', 'LastName': 'Hansen', 'Affiliation': 'Oregon Health & Science University, United States.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Herren', 'Affiliation': 'University of Washington School of Medicine, United States.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Nichol', 'Affiliation': 'University of Washington School of Medicine, United States.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'University of Texas Health Science Center at Houston, United States.'}, {'ForeName': 'Mohamud R', 'Initials': 'MR', 'LastName': 'Daya', 'Affiliation': 'Oregon Health & Science University, United States.'}]",Resuscitation,['10.1016/j.resuscitation.2020.08.004']
2478,32795738,Predictors of receptivity to an alcohol intervention among mandated students.,"OBJECTIVE


Students in violation of campus alcohol policy often must participate in an alcohol risk reduction intervention, and some mandated students express overt resistance to change. This study tested a priori hypotheses about psychological variables that might predict receptivity to an online brief alcohol intervention.
METHOD


Participants were 193 students (56% male, 88% underclassmen, 70% white) who were referred to the campus Office of Alcohol and Other Drugs after being cited for alcohol policy violations. Before their mandated online alcohol intervention, they completed a baseline assessment consisting of demographics and questionnaires about their alcohol use, attitudes toward moderate and heavy drinking, beliefs about the centrality of alcohol in college life, perceived descriptive and injunctive drinking norms, trait defensiveness, social desirability and response to the event leading to their sanction. They also responded to a set of questions about how interested in, open-minded, and likely to benefit they were from the computer-delivered alcohol intervention they were about to take.
RESULTS


Controlling for covariates and all other predictors, greater receptivity to intervention was predicted by heavier alcohol consumption, positive attitude towards moderate drinking, perceptions that peers were less approving of heavy drinking, and taking personal responsibility for the incident.
CONCLUSIONS


Among students mandated to participate in an alcohol intervention, openness to benefitting from the intervention varies in predictable ways. Because intervention receptiveness is associated with post-intervention change, we offer suggestions to tailor mandated interventions in ways that might improve outcomes.",2021,"RESULTS


Controlling for covariates and all other predictors, greater receptivity to intervention was predicted by heavier alcohol consumption, positive attitude towards moderate drinking, perceptions that peers were less approving of heavy drinking, and taking personal responsibility for the incident.
","['Participants were 193 students (56% male, 88% underclassmen, 70% white) who were referred to the campus Office of Alcohol and Other Drugs after being cited for alcohol policy violations', 'mandated students']",['alcohol intervention'],"['heavier alcohol consumption, positive attitude towards moderate drinking, perceptions that peers were less approving of heavy drinking, and taking personal responsibility']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0242456', 'cui_str': 'Policy'}]","[{'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0237428', 'cui_str': 'Positive attitude'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1515187', 'cui_str': 'Take'}]",193.0,0.0120224,"RESULTS


Controlling for covariates and all other predictors, greater receptivity to intervention was predicted by heavier alcohol consumption, positive attitude towards moderate drinking, perceptions that peers were less approving of heavy drinking, and taking personal responsibility for the incident.
","[{'ForeName': 'Kate B', 'Initials': 'KB', 'LastName': 'Carey', 'Affiliation': 'Center for Alcohol and Addiction Studies, Brown University School of Public Health, United States; Department of Behavioral and Social Sciences, Brown University School of Public Health, United States. Electronic address: Kate_Carey@Brown.edu.'}, {'ForeName': 'Angelo M', 'Initials': 'AM', 'LastName': 'DiBello', 'Affiliation': 'Center for Alcohol and Addiction Studies, Brown University School of Public Health, United States; Department of Psychology, City University of New York, Brooklyn College, United States.'}, {'ForeName': 'Elora E', 'Initials': 'EE', 'LastName': 'Orazio', 'Affiliation': 'College of Community and Public Affairs, Binghamton University, United States.'}, {'ForeName': 'Melissa R', 'Initials': 'MR', 'LastName': 'Hatch', 'Affiliation': 'Center for Alcohol and Addiction Studies, Brown University School of Public Health, United States.'}, {'ForeName': 'Nadine R', 'Initials': 'NR', 'LastName': 'Mastroleo', 'Affiliation': 'Department of Psychology, Binghamton University, United States.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106605']
2479,32800511,Efficacy and Safety of Sacubitril/Valsartan by Dose Level Achieved in the PIONEER-HF Trial.,"OBJECTIVES


This study sought to evaluate the efficacy and safety of sacubitril/valsartan according to dose level achieved in the PIONEER-HF (Comparison of Sacubitril/Valsartan Versus Enalapril on Effect on NT-proBNP in Patients Stabilized From an Acute Heart Failure Episode) trial.
BACKGROUND


In patients hospitalized for acute decompensated heart failure (ADHF), in-hospital initiation and continuation of sacubitril/valsartan as compared with enalapril is well tolerated, achieves a greater reduction in N-terminal pro-B-type natriuretic peptide (NT-proBNP), and reduces the risk of cardiovascular death or rehospitalization for HF through 8 weeks. However, not all patients achieve the target dose of sacubitril/valsartan, and its efficacy and safety in such patients are of interest.
METHODS


PIONEER-HF was a randomized, double-blind, active-controlled trial of sacubitril/valsartan versus enalapril in 881 patients stabilized during hospitalization for ADHF. Blinded study medication was administered for 8 weeks, with initial dosing selected based on the systolic blood pressure at randomization and titrated toward a target of sacubitril/valsartan 97/103 mg twice daily, or enalapril 10 mg twice daily, with an algorithm based on systolic blood pressure and the investigator's assessment of tolerability.
RESULTS


At 4 weeks, 199 (55%) patients allocated to sacubitril/valsartan and 211 (60%) patients allocated to enalapril were dispensed the target dose. Baseline characteristics were similar in the 2 treatment groups within each dose level. There was no heterogeneity across dose levels in the effect of sacubitril/valsartan on the reduction in NT-proBNP (p interaction  = 0.69), the reduction in cardiovascular death or rehospitalization for heart failure (p interaction  = 0.42), or the pre-specified adverse events of special interest through 8 weeks.
CONCLUSIONS


In hemodynamically stabilized patients with ADHF, the efficacy and safety of sacubitril/valsartan are generally consistent across dose levels. (Comparison of Sacubitril/Valsartan Versus Enalapril on Effect on NT-proBNP in Patients Stabilized From an Acute Heart Failure Episode [PIONEER-HF]; NCT02554890).",2020,"There was no heterogeneity across dose levels in the effect of sacubitril/valsartan on the reduction in NT-proBNP (p interaction  = 0.69), the reduction in cardiovascular death or rehospitalization for heart failure (p interaction  = 0.42), or the pre-specified adverse events of special interest through 8 weeks.
","['patients hospitalized for acute decompensated heart failure (ADHF), in-hospital initiation and continuation of sacubitril', 'Patients', '881 patients stabilized during hospitalization for ADHF']","['valsartan', 'Sacubitril/Valsartan Versus Enalapril', 'enalapril', 'sacubitril/valsartan', 'Sacubitril/Valsartan', 'sacubitril/valsartan 97/103\xa0mg twice daily, or enalapril', 'sacubitril/valsartan versus enalapril']","['Efficacy and Safety', 'cardiovascular death or rehospitalization for heart failure', 'NT-proBNP', 'efficacy and safety', 'systolic blood pressure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C4033447', 'cui_str': 'sacubitril'}, {'cui': 'C0184512', 'cui_str': 'Stabilized'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]","[{'cui': 'C0216784', 'cui_str': 'valsartan'}, {'cui': 'C4033631', 'cui_str': 'valsartan and sacubitril'}, {'cui': 'C0014025', 'cui_str': 'Enalapril'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}]",881.0,0.206586,"There was no heterogeneity across dose levels in the effect of sacubitril/valsartan on the reduction in NT-proBNP (p interaction  = 0.69), the reduction in cardiovascular death or rehospitalization for heart failure (p interaction  = 0.42), or the pre-specified adverse events of special interest through 8 weeks.
","[{'ForeName': 'David D', 'Initials': 'DD', 'LastName': 'Berg', 'Affiliation': ""TIMI Study Group, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts. Electronic address: dberg1@bwh.harvard.edu.""}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Braunwald', 'Affiliation': ""TIMI Study Group, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Adam D', 'Initials': 'AD', 'LastName': 'DeVore', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Anuradha', 'Initials': 'A', 'LastName': 'Lala', 'Affiliation': 'Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Sean P', 'Initials': 'SP', 'LastName': 'Pinney', 'Affiliation': 'Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Carol I', 'Initials': 'CI', 'LastName': 'Duffy', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.'}, {'ForeName': 'Yared', 'Initials': 'Y', 'LastName': 'Gurmu', 'Affiliation': ""TIMI Study Group, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Velazquez', 'Affiliation': 'Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Morrow', 'Affiliation': ""TIMI Study Group, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}]",JACC. Heart failure,['10.1016/j.jchf.2020.06.008']
2480,32805428,Prophylactic action of lipid and non-lipid tear supplements in adverse environmental conditions: A randomised crossover trial.,"PURPOSE


To evaluate the prophylactic benefits of lipid-based and non-lipid-based artificial tear lubricants, in dry eye disease, after adverse environmental exposure.
METHODS


Twenty-eight participants with dry eye disease were recruited in a prospective, double-masked, randomised crossover trial. On separate days, participants were randomised to receive a single application of a lipid-containing tear supplement (Systane Complete) to one eye, and a non-lipid containing eye drop (Systane Ultra) to the contralateral eye. Participants were then exposed to a previously validated simulated adverse environment. Symptoms, non-invasive tear film breakup time, lipid layer grade, and tear meniscus height were assessed at three time points; baseline, following eye drop instillation, and after exposure to the adverse environment.
RESULTS


Both treatments effected improvements in symptoms and non-invasive tear film stability following instillation (all p < 0.05), although an improvement in lipid layer quality was limited to the lipid-containing nano-emulsion tear supplement (p = 0.003). Although protective effects were conferred by both treatments following exposure to the simulated adverse environment, more favourable symptomology scores, non-invasive tear film stability, and lipid layer quality were observed in the lipid-containing tear supplement group (all p < 0.05). No significant changes were observed in tear meniscus height in both treatment groups (all p > 0.05).
CONCLUSIONS


Both the lipid and non-lipid-based artificial tear supplement demonstrated prophylactic benefits in a simulated adverse environment. However, the ability to preserve tear film quality and reduce dry eye symptomology was greater with the lipid-containing eye drop.
TRIAL REGISTRATION NUMBER


ACTRN12619000361101.",2020,"Both treatments effected improvements in symptoms and non-invasive tear film stability following instillation (all p < 0.05), although an improvement in lipid layer quality was limited to the lipid-containing tear supplement (p = 0.003).","['Twenty-eight participants with dry eye disease', 'adverse environmental conditions']","['lipid-containing tear supplement (Systane® Complete) to one eye, and a non-lipid containing eye drop (Systane® Ultra) to the contralateral eye', 'lipid-based and non-lipid-based artificial tear lubricants', 'lipid and non-lipid containing tear supplements']","['lipid layer quality', 'symptoms and non-invasive tear film stability', 'favourable symptomology scores, non-invasive tear film stability, and lipid layer quality', 'tear meniscus height', 'Symptoms, non-invasive tear film break-up time, lipid layer grade, and tear meniscus height', 'tear film quality and reduce dry eye symptomology']","[{'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C1655274', 'cui_str': 'Systane'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0015399', 'cui_str': 'Eye drops'}, {'cui': 'C0441988', 'cui_str': 'Contralateral'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C2608262', 'cui_str': 'Artificial Tears'}, {'cui': 'C0282222', 'cui_str': 'Lubricant'}]","[{'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C1704608', 'cui_str': 'Film'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1827565', 'cui_str': 'Tear meniscus height'}, {'cui': 'C0429495', 'cui_str': 'Tear film break-up time'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}]",28.0,0.0859293,"Both treatments effected improvements in symptoms and non-invasive tear film stability following instillation (all p < 0.05), although an improvement in lipid layer quality was limited to the lipid-containing tear supplement (p = 0.003).","[{'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Muntz', 'Affiliation': 'Department of Ophthalmology, New Zealand National Eye Centre, The University of Auckland, New Zealand.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Marasini', 'Affiliation': 'Department of Ophthalmology, New Zealand National Eye Centre, The University of Auckland, New Zealand.'}, {'ForeName': 'Michael T M', 'Initials': 'MTM', 'LastName': 'Wang', 'Affiliation': 'Department of Ophthalmology, New Zealand National Eye Centre, The University of Auckland, New Zealand.'}, {'ForeName': 'Jennifer P', 'Initials': 'JP', 'LastName': 'Craig', 'Affiliation': 'Department of Ophthalmology, New Zealand National Eye Centre, The University of Auckland, New Zealand. Electronic address: jp.craig@auckland.ac.nz.'}]",The ocular surface,['10.1016/j.jtos.2020.08.004']
2481,32813928,Can abdominal hypropressive technique improve stress urinary incontinence? an assessor-blinded randomized controlled trial.,"AIM


To verify which one improves better stress urinary incontinence (SUI) symptoms: abdominal hypopressive technique (AHT) or pelvic floor muscle training (PFMT).
METHODS


Randomized controlled trial. Women with SUI who had not participated of physiotherapy program before were invited. The outcome measures were 7-day bladder diary, International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) and pelvic floor muscles (PFM) function measured by Modified Oxford grading System with vaginal palpation and manometry with Peritron. Intervention consisted by 12 weeks of exercises program including PFMT or AHT program, in groups of maximum three women, twice a week, with physiotherapist supervision.
RESULTS


AHT and PFMT groups reduced urinary leakage episodes in 7 days, -0.64 and -1.91, respectively, but PFMT was superior, whit mean difference -1.27 (95% confidence interval [CI]: -1.92 to -0,62) and effect size was 0.94 in favor to PFMT. Regarding to total score of ICIQ-SF, both groups improved, with mean difference between groups -4.7 (95% CI: -6.90 to -2.50) and effect size was 1.04 in favor to PFMT. Manometry also presented improvement after treatment for both groups with mean difference between them of 11 (95% CI: 6.33-15.67) and effect size was 1.15 also in favor to PFMT.
CONCLUSION


Regarding to SUI symptoms, quality of life impact and PFM function both groups presented improvement, however, PFMT was superior to AHT among all of them.",2020,"Regarding to SUI symptoms, quality of life impact and PFM function both groups presented improvement, however, PFMT was superior to AHT among all of them.",['Women with SUI who had not participated of physiotherapy program before were invited'],"['PFMT', 'exercises program including PFMT or AHT program', 'hypopressive technique (AHT) or pelvic floor muscle training (PFMT']","['urinary leakage episodes', '7-day bladder diary, International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) and pelvic floor muscles (PFM) function measured by Modified Oxford grading System with vaginal palpation and manometry with Peritron', 'SUI symptoms, quality of life impact and PFM function']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042025', 'cui_str': 'Genuine stress incontinence'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0015376', 'cui_str': 'Extravasation'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0430970', 'cui_str': 'Urinary frequency volume chart'}, {'cui': 'C2711460', 'cui_str': 'International consultation on incontinence questionnaire'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1273712', 'cui_str': 'Grading system used'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0030247', 'cui_str': 'Palpation'}, {'cui': 'C0024751', 'cui_str': 'Manometry'}, {'cui': 'C0042025', 'cui_str': 'Genuine stress incontinence'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0231484', 'cui_str': 'Muscle function'}]",,0.168795,"Regarding to SUI symptoms, quality of life impact and PFM function both groups presented improvement, however, PFMT was superior to AHT among all of them.","[{'ForeName': 'Luciene A', 'Initials': 'LA', 'LastName': 'Jose-Vaz', 'Affiliation': 'Physiotherapy Department, Federal University of Uberlândia, Minas Gerais, Brazil.'}, {'ForeName': 'Carine L', 'Initials': 'CL', 'LastName': 'Andrade', 'Affiliation': 'Physiotherapy Department, Federal University of Uberlândia, Minas Gerais, Brazil.'}, {'ForeName': 'Laura C', 'Initials': 'LC', 'LastName': 'Cardoso', 'Affiliation': 'Physiotherapy Department, Federal University of Uberlândia, Minas Gerais, Brazil.'}, {'ForeName': 'Bruno T', 'Initials': 'BT', 'LastName': 'Bernardes', 'Affiliation': 'Gynecology and Obstetrics Department, Urogynaecology Ambulatory Unit, Federal University of Uberlândia, Minas Gerais, Brazil.'}, {'ForeName': 'Vanessa S', 'Initials': 'VS', 'LastName': 'Pereira-Baldon', 'Affiliation': 'Physiotherapy Department, Federal University of Uberlândia, Minas Gerais, Brazil.'}, {'ForeName': 'Ana Paula M', 'Initials': 'APM', 'LastName': 'Resende', 'Affiliation': 'Physiotherapy Department, Federal University of Uberlândia, Minas Gerais, Brazil.'}]",Neurourology and urodynamics,['10.1002/nau.24489']
2482,32816189,Exercise training affects hemodynamics not cardiac function during anthracycline-based chemotherapy.,"INTRODUCTION


Preclinical data demonstrate the potential for exercise training to protect against anthracycline-related cardiotoxicity, but this remains to be shown in humans.
PURPOSE


To assess whether exercise training during anthracycline-based chemotherapy for treatment of breast cancer affects resting cardiac function and hemodynamics.
METHODS


In this prospective, non-randomized controlled study, 26 women who participated in aerobic and resistance training 3×/wk during chemotherapy were compared to 11 women receiving usual care. Two-dimensional echocardiography was performed before and 7-14 days after completion of anthracycline-based chemotherapy. Pre- and post-anthracycline cardiac function and hemodynamic variables were compared within each group with paired t-tests; the change was compared between groups using ANCOVA with adjustment for baseline values.
RESULTS


Left ventricular longitudinal strain, volumes, ejection fraction, E/A ratio, and mass did not change in either group. Hemoglobin, hematocrit, and mean arterial pressure decreased significantly from baseline in both groups (all p < 0.05) with no differences between groups. Cardiac output increased in the usual care group only (+ 0.27 ± 0.24 L/min/m 2 , p < 0.01), which differed significantly from the exercise group (p = 0.03). Systemic vascular resistance (SVR) decreased in both groups (usual care: - 444, p < 0.01; exercise: - 265, dynes/s/cm 5 , p = 0.01). However, the reduction in SVR was significantly attenuated in the exercise group (p = 0.03) perhaps due to a compensatory decrease in estimated vessel lumen radius.
CONCLUSION


Exercise training during anthracycline chemotherapy treatment had no effect on resting cardiac function but appeared to modify hemodynamic responses. Specifically, exercise training attenuated the drop in SVR in response to chemotherapy-related reductions in hematocrit potentially by increasing vessel lumen radius.",2020,"Systemic vascular resistance (SVR) decreased in both groups (usual care: - 444, p < 0.01; exercise: - 265, dynes/s/cm 5 , p = 0.01).","['11 women receiving usual care', '26 women who participated in']","['exercise training', 'aerobic and resistance training 3×/wk during chemotherapy', 'Exercise training', 'anthracycline-based chemotherapy', 'exercise training during anthracycline-based chemotherapy']","['Hemoglobin, hematocrit, and mean arterial pressure', 'Cardiac output', 'reduction in SVR', 'Pre- and post-anthracycline cardiac function and hemodynamic variables', 'resting cardiac function', 'Left ventricular longitudinal strain, volumes, ejection fraction, E/A ratio, and mass', 'Systemic vascular resistance (SVR']","[{'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0003234', 'cui_str': 'Anthracycline'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1258192', 'cui_str': 'Systemic vascular resistance'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0003234', 'cui_str': 'Anthracycline'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}]",26.0,0.0287775,"Systemic vascular resistance (SVR) decreased in both groups (usual care: - 444, p < 0.01; exercise: - 265, dynes/s/cm 5 , p = 0.01).","[{'ForeName': 'Amy A', 'Initials': 'AA', 'LastName': 'Kirkham', 'Affiliation': 'University of Alberta, 1098 Research Transition Facility, 8308 114 Street NW, Edmonton, AB, T6G 2V2, Canada.'}, {'ForeName': 'Sean A', 'Initials': 'SA', 'LastName': 'Virani', 'Affiliation': 'University of British Columbia, 212-2177 Wesbrook Mall, Vancouver, V6T 1Z3, Canada.'}, {'ForeName': 'Kelcey A', 'Initials': 'KA', 'LastName': 'Bland', 'Affiliation': 'Australian Catholic University, 115 Victoria Parade, Fitzroy, VIC, 3065, Australia.'}, {'ForeName': 'Donald C', 'Initials': 'DC', 'LastName': 'McKenzie', 'Affiliation': 'University of British Columbia, 212-2177 Wesbrook Mall, Vancouver, V6T 1Z3, Canada.'}, {'ForeName': 'Karen A', 'Initials': 'KA', 'LastName': 'Gelmon', 'Affiliation': 'University of British Columbia, 212-2177 Wesbrook Mall, Vancouver, V6T 1Z3, Canada.'}, {'ForeName': 'Darren E R', 'Initials': 'DER', 'LastName': 'Warburton', 'Affiliation': 'University of British Columbia, 212-2177 Wesbrook Mall, Vancouver, V6T 1Z3, Canada.'}, {'ForeName': 'Kristin L', 'Initials': 'KL', 'LastName': 'Campbell', 'Affiliation': 'University of British Columbia, 212-2177 Wesbrook Mall, Vancouver, V6T 1Z3, Canada. Kristin.Campbell@ubc.ca.'}]",Breast cancer research and treatment,['10.1007/s10549-020-05824-x']
2483,32827221,Transcranial Magnetic Stimulation Promotes Gait Training in Parkinson Disease.,"OBJECTIVE


To determine whether priming with 1 or 25Hz repetitive transcranial magnetic stimulation (rTMS) will enhance the benefits from treadmill training up to 3 months postintervention in people with Parkinson disease (PD), and to evaluate the underlying changes in cortical excitability.
METHODS


This randomized double-blind, placebo-controlled trial was conducted between October 2016 and December 2018. Fifty-one participants with PD were randomized to receive 12 sessions of rTMS (25Hz, 1Hz, or sham) followed by treadmill training. All participants were assessed at baseline and 1 day, 1 month, and 3 months postintervention. Primary outcome was fastest walking speed, and secondary outcomes were timed up-and-go test (TUG), dual-task TUG (DT-TUG), motor section of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS-III), and electrophysiological evaluation of cortical excitability by TMS.
RESULTS


The 1 and 25Hz rTMS groups produced a greater improvement in fastest walking speed at 1 day and 3 months postintervention than the sham group. Only the 1 and 25Hz rTMS groups sustained the improvements in TUG, and had a significant improvement in DT-TUG and MDS-UPDRS-III for up to 3 months. Behavioral improvements correlated with increased cortical silent period and short-interval intracortical inhibition in both groups receiving real rTMS.
INTERPRETATION


Priming with 1 and 25Hz rTMS can augment the benefits of treadmill training and lead to long-term motor improvement up to 3 months postintervention. The motor improvement at follow-up was associated with a normalization of cortical excitability, which in turn suggests an alteration of the homeostatic plasticity range. Rebalancing cortical excitability by rTMS appears critical for plasticity induction. ANN NEUROL 2020;88:933-945.",2020,Behavioral improvements correlated with increased cortical silent period and short-interval intracortical inhibition in both groups receiving real rTMS.,"['Oct 2016 and Dec 2018', ""Parkinson's disease"", 'Fifty-one participants with PD', ""people with Parkinson's disease (PD""]","['Transcranial magnetic stimulation promotes gait training', '1 Hz or 25 Hz repetitive transcranial magnetic stimulation (rTMS', 'rTMS', 'rTMS (25 Hz, 1 Hz or sham) followed by treadmill training', 'placebo']","['fastest walking speed', 'cortical silent period and short-interval intracortical inhibition', 'DT-TUG and MDS-UPDRS-III', ""fastest walking speed and secondary outcomes were timed up-and-go test (TUG), dual-task TUG (DT-TUG), motor section of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS-III), and electrophysiological evaluation of cortical excitability by TMS""]","[{'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0443304', 'cui_str': 'Silent'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0026650', 'cui_str': 'Movement disorder'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C4277734', 'cui_str': 'Cortical Excitability'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}]",51.0,0.305734,Behavioral improvements correlated with increased cortical silent period and short-interval intracortical inhibition in both groups receiving real rTMS.,"[{'ForeName': 'Chloe Lau-Ha', 'Initials': 'CL', 'LastName': 'Chung', 'Affiliation': 'Department of Rehabilitation Sciences, Hong Kong Polytechnic University, Kowloon, Hong Kong.'}, {'ForeName': 'Margaret Kit-Yi', 'Initials': 'MK', 'LastName': 'Mak', 'Affiliation': 'Department of Rehabilitation Sciences, Hong Kong Polytechnic University, Kowloon, Hong Kong.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Hallett', 'Affiliation': 'Human Motor Control Section, Medical Neurology Branch, National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, Maryland, USA.'}]",Annals of neurology,['10.1002/ana.25881']
2484,32827269,Increase in endogenous glucose production with SGLT2 inhibition is attenuated in individuals who underwent kidney transplantation and bilateral native nephrectomy.,"AIMS/HYPOTHESIS


The glucosuria induced by sodium-glucose cotransporter 2 (SGLT2) inhibition stimulates endogenous (hepatic) glucose production (EGP), blunting the decline in HbA 1c . We hypothesised that, in response to glucosuria, a renal signal is generated and stimulates EGP. To examine the effect of acute administration of SGLT2 inhibitors on EGP, we studied non-diabetic individuals who had undergone renal transplant with and without removal of native kidneys.
METHODS


This was a parallel, randomised, double-blind, placebo-controlled, single-centre study, designed to evaluate the effect of a single dose of dapagliflozin or placebo on EGP determined by stable-tracer technique. We recruited non-diabetic individuals who were 30-65 years old, with a BMI of 25-35 kg/m 2  and stable body weight (±2 kg) over the preceding 3 months, and HbA 1c  <42 mmol/mol (6.0%). Participants had undergone renal transplant with and without removal of native kidneys and were on a stable dose of immunosuppressive medications. Participants received a single dose of dapagliflozin 10 mg or placebo on two separate days, at a 5- to 14-day interval, according to randomisation performed by our hospital pharmacy, which provided dapagliflozin and matching placebo, packaged in bulk bottles that were sequentially numbered. Both participants and investigators were blinded to group assignment.
RESULTS


Twenty non-diabetic renal transplant patients (ten with residual native kidneys, ten with bilateral nephrectomy) participated in the study. Dapagliflozin induced greater glucosuria in individuals with residual native kidneys vs nephrectomised individuals (8.6 ± 1.1 vs 5.5 ± 0.5 g/6 h; p = 0.02; data not shown). During the 6 h study period, plasma glucose decreased only slightly and similarly in both groups, with no difference compared with placebo (data not shown). Following administration of placebo, there was a progressive time-related decline in EGP that was similar in both nephrectomised individuals and individuals with residual native kidneys. Following dapagliflozin administration, EGP declined in both groups, but the differences between the decrement in EGP with dapagliflozin and placebo in the group with bilateral nephrectomy (Δ = 1.11 ± 0.72 μmol min -1  kg -1 ) was significantly lower (p = 0.03) than in the residual native kidney group (Δ = 2.56 ± 0.33 μmol min -1  kg -1 ). In the population treated with dapagliflozin, urinary glucose excretion was correlated with EGP (r = 0.34, p < 0.05). Plasma insulin, C-peptide, glucagon, prehepatic insulin:glucagon ratio, lactate, alanine and pyruvate concentrations were similar following placebo and dapagliflozin treatment. β-Hydroxybutyrate increased with dapagliflozin treatment in the residual native kidney group, while a small increase was observed only at 360 min in the nephrectomy group. Plasma adrenaline (epinephrine) did not change after dapagliflozin and placebo treatment in either group. Following dapagliflozin administration, plasma noradrenaline (norepinephrine) increased slightly in the residual native kidney group and decreased in the nephrectomy group.
CONCLUSIONS/INTERPRETATION


In nephrectomised individuals, the hepatic compensatory response to acute SGLT2 inhibitor-induced glucosuria was attenuated, as compared with individuals with residual native kidneys, suggesting that SGLT2 inhibitor-mediated stimulation of hepatic glucose production via efferent renal nerves occurs in an attempt to compensate for the urinary glucose loss (i.e. a renal-hepatic axis).
TRIAL REGISTRATION


ClinicalTrials.gov NCT03168295 FUNDING: This protocol was supported by Qatar National Research Fund (QNRF) Award No. NPRP 8-311-3-062 and NIH grant DK024092-38. Graphical abstract.",2020,"Following dapagliflozin administration, plasma noradrenaline (norepinephrine) increased slightly in the residual native kidney group and decreased in the nephrectomy group.
","['diabetic individuals who had undergone renal transplant with and without removal of native kidneys', 'Participants had undergone renal transplant with and without removal of native kidneys and were on a stable dose of immunosuppressive medications', 'Twenty non-diabetic renal transplant patients (ten with residual native kidneys, ten with bilateral nephrectomy) participated in the study', 'individuals who underwent kidney transplantation and bilateral native nephrectomy', 'recruited non-diabetic individuals who were 30-65\xa0years old, with a BMI of 25-35\xa0kg/m 2  and stable body weight (±2\xa0kg) over the preceding 3\xa0months, and HbA 1c  <42\xa0mmol/mol (6.0']","['dapagliflozin or placebo', 'Plasma adrenaline (epinephrine', 'dapagliflozin 10\xa0mg or placebo', 'dapagliflozin and matching placebo, packaged in bulk bottles that were sequentially numbered', 'SGLT2 inhibitors', 'dapagliflozin', 'Dapagliflozin', 'dapagliflozin and placebo', 'placebo']","['Plasma insulin, C-peptide, glucagon, prehepatic insulin:glucagon ratio, lactate, alanine and pyruvate concentrations', 'plasma noradrenaline (norepinephrine', 'glucosuria', 'urinary glucose excretion', 'plasma glucose', 'progressive time-related decline in EGP', 'β-Hydroxybutyrate', 'endogenous (hepatic) glucose production (EGP', 'EGP']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0021081', 'cui_str': 'Immunosuppressant agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0194084', 'cui_str': 'Bilateral total nephrectomy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0027695', 'cui_str': 'Kidney excision'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C3709918', 'cui_str': 'dapagliflozin 10 MG'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0179376', 'cui_str': 'Bottle'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0857690', 'cui_str': 'Plasma insulin'}, {'cui': 'C0006558', 'cui_str': 'C-peptide'}, {'cui': 'C0017687', 'cui_str': 'Glucagon'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0001898', 'cui_str': 'Alanine'}, {'cui': 'C0034354', 'cui_str': 'Pyruvates'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0017979', 'cui_str': 'Glycosuria'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205227', 'cui_str': 'Endogenous'}, {'cui': 'C0020332', 'cui_str': 'Hydroxybutyrates'}]",,0.3258,"Following dapagliflozin administration, plasma noradrenaline (norepinephrine) increased slightly in the residual native kidney group and decreased in the nephrectomy group.
","[{'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Daniele', 'Affiliation': 'Department of Clinical and Experimental Medicine, Section of Metabolic Diseases and Diabetes, University of Pisa, Via Paradisa 2, 56124, Pisa, Italy.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Solis-Herrera', 'Affiliation': 'Division of Diabetes, University of Texas Health Science Center at San Antonio, San Antonio, TX, USA.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Dardano', 'Affiliation': 'Department of Clinical and Experimental Medicine, Section of Metabolic Diseases and Diabetes, University of Pisa, Via Paradisa 2, 56124, Pisa, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Mari', 'Affiliation': 'Metabolic Unit, CNR Institute of Neuroscience, Padova, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Tura', 'Affiliation': 'Metabolic Unit, CNR Institute of Neuroscience, Padova, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Giusti', 'Affiliation': 'Department of Clinical and Experimental Medicine, Section of Metabolic Diseases and Diabetes, University of Pisa, Via Paradisa 2, 56124, Pisa, Italy.'}, {'ForeName': 'Jancy J', 'Initials': 'JJ', 'LastName': 'Kurumthodathu', 'Affiliation': 'Department of Clinical and Experimental Medicine, Section of Metabolic Diseases and Diabetes, University of Pisa, Via Paradisa 2, 56124, Pisa, Italy.'}, {'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'Campi', 'Affiliation': 'Department of Clinical and Experimental Medicine, Section of Metabolic Diseases and Diabetes, University of Pisa, Via Paradisa 2, 56124, Pisa, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Saba', 'Affiliation': 'Department of Clinical and Experimental Medicine, Section of Metabolic Diseases and Diabetes, University of Pisa, Via Paradisa 2, 56124, Pisa, Italy.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Bianchi', 'Affiliation': 'Department of Clinical and Experimental Medicine, Section of Metabolic Diseases and Diabetes, University of Pisa, Via Paradisa 2, 56124, Pisa, Italy.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Tregnaghi', 'Affiliation': 'Department of Clinical and Experimental Medicine, Section of Metabolic Diseases and Diabetes, University of Pisa, Via Paradisa 2, 56124, Pisa, Italy.'}, {'ForeName': 'Maria Francesca', 'Initials': 'MF', 'LastName': 'Egidi', 'Affiliation': 'Department of Clinical and Experimental Medicine, Section of Metabolic Diseases and Diabetes, University of Pisa, Via Paradisa 2, 56124, Pisa, Italy.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Abdul-Ghani', 'Affiliation': 'Division of Diabetes, University of Texas Health Science Center at San Antonio, San Antonio, TX, USA.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'DeFronzo', 'Affiliation': 'Division of Diabetes, University of Texas Health Science Center at San Antonio, San Antonio, TX, USA.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Del Prato', 'Affiliation': 'Department of Clinical and Experimental Medicine, Section of Metabolic Diseases and Diabetes, University of Pisa, Via Paradisa 2, 56124, Pisa, Italy. stefano.delprato@med.unipi.it.'}]",Diabetologia,['10.1007/s00125-020-05254-w']
2485,32827645,Evaluation of Gasless Laparoscopy as a Tool for Minimal Access Surgery in Low-to Middle-Income Countries: A Phase II Noninferiority Randomized Controlled Study.,"BACKGROUND


Minimal access surgery is not available to most people in rural areas of low-to middle-income countries. This leads to an increase in morbidity and economic loss to the poor and marginalized. Gasless laparoscopic (GAL) procedures are possible in rural areas because they can be performed under spinal anesthesia. In most cases, it does not require the logistics of providing gases for pneumoperitoneum and general anesthesia. The current study compares GAL with conventional laparoscopic (COL) operations for general surgical procedures.
METHODS


A single-center, nonblinded randomized controlled trial was conducted to evaluate noninferiority of GAL vs COL at a teaching hospital in New Delhi, India. Patients were allocated into 3 groups and underwent minimal access surgery (cholecystectomies and appendectomies). The procedures were performed by 2 surgeons choosing randomly between GAL and COL. The data were collected by postgraduates and analyzed by a biostatistician.
RESULTS


One hundred patients who met the inclusion criteria were allocated into 2 groups. No significant difference was observed in the mean operating time between the GAL group (52.9 minutes) and the COL group (55 minutes) (p = 0.3). Intraoperative vital signs were better in the GAL group (p < 0.05). The postoperative pain score was slightly higher in the GAL group (p = 0.01); however, it did not require additional analgesics.
CONCLUSIONS


No significant differences were found between the 2 groups. GAL can be considered as noninferior compared with COL and has the potential to be adopted in low-resource settings.",2020,The intraoperative vital signs were better in the GAL group [p < 0.05].,['100 patients who met the inclusion criteria'],"['GAL versus COL', 'MAS (Cholecystectomies and appendectomies', 'Gasless Laparoscopy', 'RCT', 'Gasless laparoscopic surgeries [GAL', 'Minimal access surgery [MAS', 'GAL', 'conventional Laparoscopic surgeries [COL']","['postoperative pain score', 'mean operating time', 'intraoperative vital signs']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0060993', 'cui_str': 'Galanin'}, {'cui': 'C0009413', 'cui_str': 'Colostrum'}, {'cui': 'C0008320', 'cui_str': 'Cholecystectomy'}, {'cui': 'C0003611', 'cui_str': 'Appendectomy'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}]",100.0,0.035368,The intraoperative vital signs were better in the GAL group [p < 0.05].,"[{'ForeName': 'Anurag', 'Initials': 'A', 'LastName': 'Mishra', 'Affiliation': 'Department of Surgery, Maulana Azad Medical College, New Delhi, India. Electronic address: anurag.alok@gmail.com.'}, {'ForeName': 'Lovenish', 'Initials': 'L', 'LastName': 'Bains', 'Affiliation': 'Department of Surgery, Maulana Azad Medical College, New Delhi, India.'}, {'ForeName': 'Gnanaraj', 'Initials': 'G', 'LastName': 'Jesudin', 'Affiliation': 'Project GILLS Association of Rural Surgeons of India, Dimapur, Nagaland, India.'}, {'ForeName': 'Noel', 'Initials': 'N', 'LastName': 'Aruparayil', 'Affiliation': ""Leeds Institute of Medical Research at St James's, University of Leeds, Leeds, UK.""}, {'ForeName': 'Rajdeep', 'Initials': 'R', 'LastName': 'Singh', 'Affiliation': 'Department of Surgery, Maulana Azad Medical College, New Delhi, India.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Shashi', 'Affiliation': 'Department of Surgery, Maulana Azad Medical College, New Delhi, India.'}]",Journal of the American College of Surgeons,['10.1016/j.jamcollsurg.2020.07.783']
2486,32828135,Hydroxychloroquine in the Treatment of COVID-19: A Multicenter Randomized Controlled Study.,"The COVID-19 pandemic is showing an exponential growth, mandating an urgent need to develop an effective treatment. Indeed, to date, a well-established therapy is still lacking. We aimed to evaluate the safety and efficacy of hydroxychloroquine (HCQ) added to standard care in patients with COVID-19. This was a multicenter, randomized controlled trial conducted at three major university hospitals in Egypt. One hundred ninety-four patients with confirmed diagnosis of COVID-19 were included in the study after signing informed consent. They were equally randomized into two arms: 97 patients administrated HCQ plus standard care (HCQ group) and 97 patients administered only standard care as a control arm (control group). The primary endpoints were recovery within 28 days, need for mechanical ventilation, or death. The two groups were matched for age and gender. There was no significant difference between them regarding any of the baseline characteristics or laboratory parameters. Four patients (4.1%) in the HCQ group and 5 (5.2%) patients in the control group needed mechanical ventilation ( P  = 0.75). The overall mortality did not differ between the two groups, as six patients (6.2%) died in the HCQ group and 5 (5.2%) died in the control group ( P  = 0.77). Univariate logistic regression analysis showed that HCQ treatment was not significantly associated with decreased mortality in COVID-19 patients. So, adding HCQ to standard care did not add significant benefit, did not decrease the need for ventilation, and did not reduce mortality rates in COVID-19 patients.",2020,"The overall mortality did not differ between the two groups, as six patients (6.2%) died in the HCQ group and 5 (5.2%) died in the control group ( P  = 0.77).","['patients with COVID-19', 'COVID-19', 'three major university hospitals in Egypt', 'One hundred ninety-four patients with confirmed diagnosis of COVID-19 were included in the study after signing informed consent']","['HCQ plus standard care (HCQ group) and 97 patients administered only standard care as a control arm (control group', 'Hydroxychloroquine', 'hydroxychloroquine (HCQ', 'HCQ']","['mechanical ventilation', 'mortality rates', 'safety and efficacy', 'recovery within 28 days, need for mechanical ventilation, or death', 'overall mortality', 'mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0013715', 'cui_str': 'Egypt'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",194.0,0.126559,"The overall mortality did not differ between the two groups, as six patients (6.2%) died in the HCQ group and 5 (5.2%) died in the control group ( P  = 0.77).","[{'ForeName': 'Sherief', 'Initials': 'S', 'LastName': 'Abd-Elsalam', 'Affiliation': 'Department of Tropical Medicine and Infectious Diseases, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Eslam Saber', 'Initials': 'ES', 'LastName': 'Esmail', 'Affiliation': 'Department of Tropical Medicine and Infectious Diseases, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Mai', 'Initials': 'M', 'LastName': 'Khalaf', 'Affiliation': 'Department of Tropical Medicine and Infectious Diseases, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Ehab Fawzy', 'Initials': 'EF', 'LastName': 'Abdo', 'Affiliation': 'Department of Gastroenterology and Tropical Medicine, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Mohammed A', 'Initials': 'MA', 'LastName': 'Medhat', 'Affiliation': 'Department of Gastroenterology and Tropical Medicine, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Mohamed Samir', 'Initials': 'MS', 'LastName': 'Abd El Ghafar', 'Affiliation': 'Department of Anesthesia, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Ossama Ashraf', 'Initials': 'OA', 'LastName': 'Ahmed', 'Affiliation': 'Department of Internal Medicine, Ain-Shams University, Cairo, Egypt.'}, {'ForeName': 'Shaimaa', 'Initials': 'S', 'LastName': 'Soliman', 'Affiliation': 'Public Health and Community Medicine, Menoufia University, Menoufia, Egypt.'}, {'ForeName': 'Ghada N', 'Initials': 'GN', 'LastName': 'Serangawy', 'Affiliation': 'Department of Forensic Medicine and Toxicology, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Alboraie', 'Affiliation': 'Department of Internal Medicine, Al-Azhar University, Cairo, Egypt.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.20-0873']
2487,32798840,Mouse nerve growth factor promotes neurological recovery in patients with acute intracerebral hemorrhage: A proof-of-concept study.,"BACKGROUND


ew drugs were confirmed to be effective in the treatments of neurological dysfunction caused by acute intracerebral hemorrhage (ICH). The present prospective clinical trial aims to evaluate the effect of mouse nerve growth factor (mNGF) on neurological function in patients with acute ICH.
METHODS


60 patients with acute spontaneous ICH were randomized to receive mNGF (mNGF group) and citicoline (control group) for 4 weeks within 24-72 h after onset, respectively. The primary outcome was difference in the neurological functional outcome at 3 months by the modified Rankin Scale score (mRS). The secondary outcomes were the changes in hematoma volume at 4 weeks and 3 months.
RESULTS


There were 55 patients receiving treatment (29 patients in the mNGF group, 26 patients in the control group). Among the patients, 46 patients finished the trial at 3 months; the odds of a shift towards death or dependence (mRS > 3) at 3 months in the mNGF group were lower than that in the control group with adjustment for age, sex, NIHSS at admission, and hematoma volume at admission (adjusted OR, 0.185; 95%CI, 0.059-0.582; P = 0.0039). The hematoma was gradually reduced in all 46 patients and absorbed after non-surgical treatment at 3 months. There was no significant difference in hematoma volume between the two groups. No serious adverse event was found.
CONCLUSIONS


The administration of mNGF and citicoline was well-tolerated in patients with acute ICH. mNGF was associated with improved neurological function and less disability in patients with ICH. Therefore, the quality of life of patients with ICH may be improved by mNGF.
TRIAL REGISTRATION


The trial is registered with the Chinese Clinical Trial Registry, number ChiCTR1800020258.",2020,There was no significant difference in hematoma volume between the two groups.,"['patients with acute ICH', 'patients with acute intracerebral hemorrhage', '55 patients receiving treatment (29 patients in the mNGF group, 26 patients in the control group', '60 patients with acute spontaneous ICH', 'patients with ICH']","['mNGF and citicoline', 'mNGF', 'mNGF (mNGF group) and citicoline (control group', 'mouse nerve growth factor (mNGF', 'Mouse nerve growth factor']","['quality of life', 'neurological functional outcome', 'hematoma', 'modified Rankin Scale score (mRS', 'changes in hematoma volume', 'neurological function', 'hematoma volume']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0025914', 'cui_str': 'Mouse'}, {'cui': 'C0027752', 'cui_str': 'Nerve Growth Factor'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}]","[{'cui': 'C0025914', 'cui_str': 'Mouse'}, {'cui': 'C0027752', 'cui_str': 'Nerve Growth Factor'}, {'cui': 'C0010725', 'cui_str': 'Citicoline'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0027767', 'cui_str': 'Nervous system function'}]",60.0,0.0533032,There was no significant difference in hematoma volume between the two groups.,"[{'ForeName': 'Shuo', 'Initials': 'S', 'LastName': 'An', 'Affiliation': 'Key Laboratory of Post-Neurotrauma Neurorepair and Regeneration in Central Nervous System, Ministry of Education in China and Tianjin, Tianjin Neurological Institute, Tianjin, China; Department of Neurosurgery, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Jia', 'Affiliation': 'Department of Rehabilitation Medicine, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Tian', 'Affiliation': 'Key Laboratory of Post-Neurotrauma Neurorepair and Regeneration in Central Nervous System, Ministry of Education in China and Tianjin, Tianjin Neurological Institute, Tianjin, China; Department of Neurosurgery, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Key Laboratory of Post-Neurotrauma Neurorepair and Regeneration in Central Nervous System, Ministry of Education in China and Tianjin, Tianjin Neurological Institute, Tianjin, China; Department of Neurosurgery, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Yingsheng', 'Initials': 'Y', 'LastName': 'Wei', 'Affiliation': 'Key Laboratory of Post-Neurotrauma Neurorepair and Regeneration in Central Nervous System, Ministry of Education in China and Tianjin, Tianjin Neurological Institute, Tianjin, China; Department of Neurosurgery, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Shuyuan', 'Initials': 'S', 'LastName': 'Yue', 'Affiliation': 'Key Laboratory of Post-Neurotrauma Neurorepair and Regeneration in Central Nervous System, Ministry of Education in China and Tianjin, Tianjin Neurological Institute, Tianjin, China; Department of Neurosurgery, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Lijuan', 'Initials': 'L', 'LastName': 'Lin', 'Affiliation': 'Department of Biostatistics, Center for Global Health, School of Public Health, Nanjing Medical University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Yongyue', 'Initials': 'Y', 'LastName': 'Wei', 'Affiliation': 'Department of Biostatistics, Center for Global Health, School of Public Health, Nanjing Medical University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Key Laboratory of Post-Neurotrauma Neurorepair and Regeneration in Central Nervous System, Ministry of Education in China and Tianjin, Tianjin Neurological Institute, Tianjin, China; Department of Neurosurgery, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Lei', 'Affiliation': 'Laboratory of Neuro-Trauma and Neurodegenerative Disorders, Tianjin Geriatrics Institute, Tianjin Medical University General Hospital, Tianjin, China; Department of Geriatrics, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Jianning', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Key Laboratory of Post-Neurotrauma Neurorepair and Regeneration in Central Nervous System, Ministry of Education in China and Tianjin, Tianjin Neurological Institute, Tianjin, China; Department of Neurosurgery, Tianjin Medical University General Hospital, Tianjin, China. Electronic address: jianningzhang@hotmail.com.'}, {'ForeName': 'Rongcai', 'Initials': 'R', 'LastName': 'Jiang', 'Affiliation': 'Key Laboratory of Post-Neurotrauma Neurorepair and Regeneration in Central Nervous System, Ministry of Education in China and Tianjin, Tianjin Neurological Institute, Tianjin, China; Department of Neurosurgery, Tianjin Medical University General Hospital, Tianjin, China. Electronic address: jiang116216@163.com.'}]",Journal of the neurological sciences,['10.1016/j.jns.2020.117069']
2488,32800407,Preventing Parastomal Hernia After Ileal Conduit by the Use of a Prophylactic Mesh: A Randomised Study.,"BACKGROUND


Parastomal hernia (PSH) after urinary diversion with ileal conduit is frequently a clinical problem.
OBJECTIVE


To investigate whether a prophylactic lightweight mesh in the sublay position can reduce the cumulative incidence of PSH after open cystectomy with ileal conduit.
DESIGN, SETTING, AND PARTICIPANTS


From 2012 to 2017, we randomised 242 patients 1:1 to conventional stoma construction (n = 124) or prophylactic mesh (n = 118) at three Swedish hospitals (ISRCTN 95093825).
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS


The primary endpoint was clinical PSH, and secondary endpoints were radiological PSH assessed in prone position with the stoma in the centre of a ring, parastomal bulging, and complications from the mesh.
RESULTS AND LIMITATIONS


Within 24 mo, 20/89 (23%) patients in the control arm and 10/92 (11%) in the intervention arm had developed a clinical PSH (p = 0.06) after a median follow-up of 3 yr, corresponding to a hazard ratio of 0.45 (confidence interval 0.24-0.86, p = 0.02) in the intervention arm. The proportions of radiological PSHs within 24 mo were 22/89 (25%) and 17/92 (19%) in the two study arms. During follow-up, five patients in the control arm and two in the intervention arm were operated for PSH. The median operating time was 50 min longer in patients receiving a mesh. No differences were noted in proportions of Clavien-Dindo complications at 90 d postoperatively or in complications related to the mesh during follow-up.
CONCLUSIONS


Prophylactic implantation of a lightweight mesh in the sublay position decreases the risk of PSH when constructing an ileal conduit without increasing the risk of complications related to the mesh. The median surgical time is prolonged by mesh implantation.
PATIENT SUMMARY


In this randomised report, we looked at the risk of parastomal hernia after cystectomy and urinary diversion with ileal conduit with or without the use of a prophylactic mesh. We conclude that such a prophylactic measure decreased the occurrence of parastomal hernias, with only a slight increase in operating time and no added risk of complications related to the mesh.",2020,"No differences were noted in proportions of Clavien-Dindo complications at 90 d postoperatively or in complications related to the mesh during follow-up.
","['From 2012 to 2017, we randomised 242 patients 1:1 to']","['conventional stoma construction (n\u2009=\u2009124) or prophylactic mesh', 'prophylactic lightweight mesh', 'parastomal hernia after cystectomy and urinary diversion with ileal conduit with or without the use of a prophylactic mesh', 'Parastomal hernia (PSH', 'PSH']","['operating time and no added risk of complications', 'cumulative incidence of PSH', 'proportions of Clavien-Dindo complications', 'Parastomal Hernia', 'occurrence of parastomal hernias', 'median surgical time', 'median operating time', 'radiological PSH assessed in prone position with the stoma in the centre of a ring, parastomal bulging, and complications from the mesh', 'proportions of radiological PSHs', 'clinical PSH']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C1955856', 'cui_str': 'Stoma site'}, {'cui': 'C0403066', 'cui_str': 'Construction worker'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0341539', 'cui_str': 'Parastomal hernia'}, {'cui': 'C0010651', 'cui_str': 'Bladder excision'}, {'cui': 'C0042020', 'cui_str': 'Urinary diversion procedure'}, {'cui': 'C0348002', 'cui_str': 'Ileal Conduit'}, {'cui': 'C1524063', 'cui_str': 'Use of'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0341539', 'cui_str': 'Parastomal hernia'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0033422', 'cui_str': 'Prone body position'}, {'cui': 'C1955856', 'cui_str': 'Stoma site'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0521164', 'cui_str': 'Annular shape'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]",,0.145442,"No differences were noted in proportions of Clavien-Dindo complications at 90 d postoperatively or in complications related to the mesh during follow-up.
","[{'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Liedberg', 'Affiliation': 'Institution of Translational Medicine, Lund University, Malmö, Sweden; Department of Urology, Skåne University Hospital, Malmö, Sweden. Electronic address: fredrik.liedberg@med.lu.se.'}, {'ForeName': 'Petter', 'Initials': 'P', 'LastName': 'Kollberg', 'Affiliation': 'Institution of Translational Medicine, Lund University, Malmö, Sweden; Department of Urology, Skåne University Hospital, Malmö, Sweden; Department of Urology, Helsingborg County Hospital, Helsingborg, Sweden.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Allerbo', 'Affiliation': 'Department of Urology, Helsingborg County Hospital, Helsingborg, Sweden.'}, {'ForeName': 'Gediminas', 'Initials': 'G', 'LastName': 'Baseckas', 'Affiliation': 'Institution of Translational Medicine, Lund University, Malmö, Sweden; Department of Urology, Skåne University Hospital, Malmö, Sweden.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Brändstedt', 'Affiliation': 'Institution of Translational Medicine, Lund University, Malmö, Sweden; Department of Urology, Skåne University Hospital, Malmö, Sweden.'}, {'ForeName': 'Sigurdur', 'Initials': 'S', 'LastName': 'Gudjonsson', 'Affiliation': 'Department of Urology, Landspitali University Hospital, Reykjavik, Iceland.'}, {'ForeName': 'Oskar', 'Initials': 'O', 'LastName': 'Hagberg', 'Affiliation': 'Institution of Translational Medicine, Lund University, Malmö, Sweden; Regional Cancer Centre South, Region Skåne, Lund, Sweden.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Håkansson', 'Affiliation': 'Department of Urology, Skåne University Hospital, Malmö, Sweden.'}, {'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Jerlström', 'Affiliation': 'Department of Urology, School of Health and Medical Sciences, Örebro University, Örebro, Sweden.'}, {'ForeName': 'Annica', 'Initials': 'A', 'LastName': 'Löfgren', 'Affiliation': 'Institution of Translational Medicine, Lund University, Malmö, Sweden.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Patschan', 'Affiliation': 'Institution of Translational Medicine, Lund University, Malmö, Sweden; Department of Urology, Skåne University Hospital, Malmö, Sweden.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Sörenby', 'Affiliation': 'Institution of Translational Medicine, Lund University, Malmö, Sweden; Department of Urology, Skåne University Hospital, Malmö, Sweden.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Bläckberg', 'Affiliation': 'Department of Urology, Helsingborg County Hospital, Helsingborg, Sweden.'}]",European urology,['10.1016/j.eururo.2020.07.033']
2489,32808029,"L-Cysteine Containing Vitamin Supplement Which Prevents or Alleviates Alcohol-related Hangover Symptoms: Nausea, Headache, Stress and Anxiety.","AIMS


Alcohol-related hangover symptoms: nausea, headache, stress and anxiety cause globally considerable amount of health problems and economic losses. Many of these harmful effects are produced by alcohol and its metabolite, acetaldehyde, which also is a common ingredient in alcohol beverages. The aim of the present study is to investigate the effect of the amino acid L-cysteine on the alcohol/acetaldehyde related aftereffects.
METHODS


Voluntary healthy participants were recruited through advertisements. Volunteers had to have experience of hangover and/or headache. The hangover study was randomized, double-blind and placebo-controlled. Nineteen males randomly swallowed placebo and L-cysteine tablets. The alcohol dose was 1.5 g/kg, which was consumed during 3 h.
RESULTS


The primary results based on correlational analysis showed that L-cysteine prevents or alleviates hangover, nausea, headache, stress and anxiety. For hangover, nausea and headache the results were apparent with the L-cysteine dose of 1200 mg and for stress and anxiety already with the dose of 600 mg.
CONCLUSIONS


L-cysteine would reduce the need of drinking the next day with no or less hangover symptoms: nausea, headache, stress and anxiety. Altogether, these effects of L-cysteine are unique and seem to have a future in preventing or alleviating these harmful symptoms as well as reducing the risk of alcohol addiction.",2020,"The primary results based on correlational analysis showed that L-cysteine prevents or alleviates hangover, nausea, headache, stress and anxiety.","['Nineteen males randomly', 'Volunteers had to have experience of hangover and/or headache', 'Voluntary healthy participants were recruited through advertisements']","['L-Cysteine Containing Vitamin Supplement', 'swallowed placebo and L-cysteine tablets', 'amino acid L-cysteine', 'placebo']","['hangover symptoms: nausea, headache, stress and anxiety', 'alleviates hangover, nausea, headache, stress and anxiety', 'Hangover Symptoms: Nausea, Headache, Stress and Anxiety']","[{'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0221100', 'cui_str': 'Hangover'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}]","[{'cui': 'C0010654', 'cui_str': 'Cysteine'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0301532', 'cui_str': 'Multivitamin preparation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0002520', 'cui_str': 'amino acids'}]","[{'cui': 'C0221100', 'cui_str': 'Hangover'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",19.0,0.119041,"The primary results based on correlational analysis showed that L-cysteine prevents or alleviates hangover, nausea, headache, stress and anxiety.","[{'ForeName': 'C J Peter', 'Initials': 'CJP', 'LastName': 'Eriksson', 'Affiliation': 'Department of Public Health, University of Helsinki, Yliopistonkatu 4, 00100 Helsinki, Finland.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Metsälä', 'Affiliation': 'Department of Chemistry, University of Helsinki, Yliopistonkatu 4, 00100 Helsinki, Finland.'}, {'ForeName': 'Tommi', 'Initials': 'T', 'LastName': 'Möykkynen', 'Affiliation': 'Department of Biosciences, University of Helsinki, Yliopistonkatu 4, 00100 Helsinki, Finland.'}, {'ForeName': 'Heikki', 'Initials': 'H', 'LastName': 'Mäkisalo', 'Affiliation': 'Transplantation and Liver Surgery Unit, Helsinki University Hospital, University of Helsinki, Yliopistonkatu 4, 00100 Helsinki, Finland.'}, {'ForeName': 'Olli', 'Initials': 'O', 'LastName': 'Kärkkäinen', 'Affiliation': 'School of Pharmacy, University of Eastern Finland, Yliopistonranta 1 C, 70211 Kuopio, Finland.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Palmén', 'Affiliation': 'Schildts & Söderströms, Snellmaninkatu 13, 00170 Helsinki, Finland.'}, {'ForeName': 'Joonas E', 'Initials': 'JE', 'LastName': 'Salminen', 'Affiliation': 'Department of Chemistry, University of Helsinki, Yliopistonkatu 4, 00100 Helsinki, Finland.'}, {'ForeName': 'Jussi', 'Initials': 'J', 'LastName': 'Kauhanen', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, University of Eastern Finland, Yliopistonranta 1 C, 70211 Kuopio, Finland.'}]","Alcohol and alcoholism (Oxford, Oxfordshire)",['10.1093/alcalc/agaa082']
2490,32808163,"A Phase 4, Open-Label, Single-Arm Study Assessing the Efficacy and Safety of Ivabradine in African American Patients with Heart Failure and Reduced Ejection Fraction.","INTRODUCTION


There are limited data on ivabradine therapy in black patients and none in African Americans. We performed an open-label, prospective study at two centers in the United States. African American patients with heart failure (HF) (N = 30), left ventricular ejection fraction ≤ 35%, and in sinus rhythm with resting heart rate (HR) ≥ 70 bpm received ivabradine 2.5-7.5 mg twice daily for 57 days.
METHODS


The primary endpoint was change in HR from baseline to day 57, compared with the -5 bpm change observed in the absence of ivabradine in the placebo group of the SHIFT study. The safety endpoint was treatment-emergent adverse events (TEAEs). Exploratory endpoints were change from baseline to day 57 in 6-minute walk test (6MWT) distance, HR difference during a 6MWT (i.e. HR at minute 6 - resting HR), and physical activity counts.
RESULTS


At day 57, the estimated least squares mean change from baseline in HR was -9.5 bpm (95% CI -13.0, -6.0). The estimated mean treatment difference with ivabradine versus a presumed -5 bpm change from baseline HR, as seen in the placebo group of the SHIFT study, was -4.5 bpm (95% CI -8.0, -1.0; p = 0.013). The mean (SE) changes in 6MWT distance and HR difference during the 6MWT were 16.3 (10.8) meters and 2.3 (3.7) bpm, respectively. Ivabradine therapy did not result in greater physical activity. TEAEs were reported in 11 (36.7%) patients.
CONCLUSION


These data support ivabradine use in African American patients with HF with reduced ejection fraction who meet typical treatment criteria.
TRIAL REGISTRATION


ClinicalTrials.gov identifier, NCT03456856.",2020,"The mean (SE) changes in 6MWT distance and HR difference during the 6MWT were 16.3 (10.8) meters and 2.3 (3.7) bpm, respectively.","['black patients and none in African Americans', 'African American Patients with Heart Failure and Reduced Ejection Fraction', 'African American patients with heart failure (HF', 'African American patients with HF with reduced ejection fraction who meet typical treatment criteria']","['ivabradine', 'Ivabradine', 'ivabradine 2.5-7.5\xa0mg twice daily for 57\xa0days', 'Ivabradine therapy']","['change in HR', 'greater physical activity', '6-minute walk test (6MWT) distance, HR difference during a 6MWT (i.e. HR at minute 6 - resting HR), and physical activity counts', 'sinus rhythm with resting heart rate (HR)\u2009≥', 'mean (SE) changes in 6MWT distance and HR difference']","[{'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0257190', 'cui_str': 'ivabradine'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C1821417', 'cui_str': 'Resting heart rate'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0232201', 'cui_str': 'Sinus rhythm'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.117285,"The mean (SE) changes in 6MWT distance and HR difference during the 6MWT were 16.3 (10.8) meters and 2.3 (3.7) bpm, respectively.","[{'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Lanfear', 'Affiliation': 'Henry Ford Health System, Detroit, MI, USA. DLANFEA1@hfhs.org.'}, {'ForeName': 'Kelsey R', 'Initials': 'KR', 'LastName': 'Neaton', 'Affiliation': 'Henry Ford Health System, Detroit, MI, USA.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Lu', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Yimeng', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Ricardo E', 'Initials': 'RE', 'LastName': 'Dent-Acosta', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}]",Cardiology and therapy,['10.1007/s40119-020-00196-1']
2491,32811378,Higher Doses Improve Walking Recovery During Stroke Inpatient Rehabilitation.,"BACKGROUND AND PURPOSE


We investigated the effect of higher therapeutic exercise doses on walking during inpatient rehabilitation, typically commencing 1 to 4 weeks poststroke.
METHODS


This phase II, blinded-assessor, randomized controlled trial recruited from 6 Canadian inpatient rehabilitation units, between 2014 and 2018. Subjects (n=75; 25/group) were randomized into: control (usual care) physical therapy: typically, 1 hour, 5 days/week; Determining Optimal Post-Stroke Exercise (DOSE1): 1 hour, 5 days/week, more than double the intensity of Control (based on aerobic minutes and walking steps); and DOSE2: 2 hours, 5 days/week, more than quadruple the intensity of Control, each for 4 weeks duration. The primary outcome, walking endurance at completion of the 4-week intervention (post-evaluation), was compared across these groups using linear regression. Secondary outcomes at post-evaluation, and longitudinal outcomes at 6 and 12-month evaluations, were also analyzed.
RESULTS


Both DOSE1 (mean change 61 m [95% CI, 9-113],  P =0.02) and DOSE2 (mean change 58 m, 6-110,  P =0.03) demonstrated greater walking endurance compared with Control at the post-evaluation. Significant improvements were also observed with DOSE2 in gait speed (5-m walk), and both DOSE groups in quality of life (EQ-5D-5 L) compared with Control. Longitudinal analyses revealed that improvements in walking endurance from the DOSE intervention were retained during the 1-year follow-up period over usual care.
CONCLUSIONS


This study provides the first preliminary evidence that patients with stroke can improve their walking recovery and quality of life with higher doses of aerobic and stepping activity within a critical time period for neurological recovery. Furthermore, walking endurance benefits achieved from a 4-week intervention are retained over the first-year poststroke. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01915368.",2020,"Significant improvements were also observed with DOSE2 in gait speed (5-m walk), and both DOSE groups in quality of life (EQ-5D-5 L) compared with Control.","['Subjects (n=75; 25/group', '6 Canadian inpatient rehabilitation units, between 2014 and 2018', 'patients with stroke']","['control (usual care) physical therapy', 'DOSE1']","['DOSE2 in gait speed (5-m walk', 'Walking Recovery', 'quality of life (EQ-5D-5 L', 'DOSE2', 'walking endurance at completion of the 4-week intervention (post-evaluation', 'walking endurance benefits', 'walking endurance']","[{'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}]","[{'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}]",,0.0592141,"Significant improvements were also observed with DOSE2 in gait speed (5-m walk), and both DOSE groups in quality of life (EQ-5D-5 L) compared with Control.","[{'ForeName': 'Tara D', 'Initials': 'TD', 'LastName': 'Klassen', 'Affiliation': 'Department of Physical Therapy (T.D.K., T.L.-A., A.S., J.J.E.), University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Sean P', 'Initials': 'SP', 'LastName': 'Dukelow', 'Affiliation': 'Department of Clinical Neurosciences, Hotchkiss Brain Institute (S.P.D., M.D.H.)University of Calgary, Canada.'}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Bayley', 'Affiliation': 'Division of Physical Medicine and Rehabilitation, University of Toronto, Canada (M.T.B.).'}, {'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Benavente', 'Affiliation': 'Division of Neurology (O.B.), University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Hill', 'Affiliation': 'Department of Clinical Neurosciences, Hotchkiss Brain Institute (S.P.D., M.D.H.)University of Calgary, Canada.'}, {'ForeName': 'Andrei', 'Initials': 'A', 'LastName': 'Krassioukov', 'Affiliation': 'Division of Physical Medicine and Rehabilitation (A.K., J.Y.), University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Liu-Ambrose', 'Affiliation': 'Department of Physical Therapy (T.D.K., T.L.-A., A.S., J.J.E.), University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Sepideh', 'Initials': 'S', 'LastName': 'Pooyania', 'Affiliation': 'Division of Physical Medicine and Rehabilitation, University of Manitoba (S.P.).'}, {'ForeName': 'Marc J', 'Initials': 'MJ', 'LastName': 'Poulin', 'Affiliation': 'Department of Physiology & Pharmacology (M.J.P.) University of Calgary, Canada.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Schneeberg', 'Affiliation': 'Department of Physical Therapy (T.D.K., T.L.-A., A.S., J.J.E.), University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Yao', 'Affiliation': 'Division of Physical Medicine and Rehabilitation (A.K., J.Y.), University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Janice J', 'Initials': 'JJ', 'LastName': 'Eng', 'Affiliation': 'Department of Physical Therapy (T.D.K., T.L.-A., A.S., J.J.E.), University of British Columbia, Vancouver, Canada.'}]",Stroke,['10.1161/STROKEAHA.120.029245']
2492,32820334,Effect of dapagliflozin according to baseline systolic blood pressure in the Dapagliflozin and Prevention of Adverse Outcomes in Heart Failure trial (DAPA-HF).,"AIMS


Concern about hypotension often leads to withholding of beneficial therapy in patients with heart failure and reduced ejection fraction (HFrEF). We evaluated the efficacy and safety of dapagliflozin, which lowers systolic blood pressure (SBP),according to baseline SBP in Dapagliflozin and Prevention of Adverse Outcomes in Heart Failure trial (DAPA-HF).
METHODS AND RESULTS


Key inclusion criteria were: New York Heart Association Class II-IV, left ventricular ejection fraction ≤ 40%, elevated N-terminal pro-B-type natriuretic peptide level, and SBP ≥95 mmHg. The primary outcome was a composite of worsening heart failure or cardiovascular death. The efficacy and safety of dapagliflozin were examined using SBP as both a categorical and continuous variable. A total of 1205 patients had a baseline SBP <110 mmHg; 981 ≥ 110 < 120; 1149 ≥ 120 < 130; and 1409 ≥ 130 mmHg. The placebo-corrected reduction in SBP from baseline to 2 weeks with dapagliflozin was -2.54 (-3.33 to -1.76) mmHg (P < 0.001), with a smaller between-treatment difference in patients in the lowest compared to highest SBP category. Patients in the lowest SBP category had a much higher rate (per 100 person-years) of the primary outcome [20.6, 95% confidence interval (95% CI) 17.6-24.2] than those in the highest SBP category (13.8, 11.7-16.4). The benefit and safety of dapagliflozin was consistent across the range of SBP; hazard ratio (95% CI) in each SBP group, lowest to highest: 0.76 (0.60-0.97), 0.76 (0.57-1.02), 0.81 (0.61-1.08), and 0.67 (0.51-0.87), P interaction = 0.78. Study drug discontinuation did not differ between dapagliflozin and placebo across the SBP categories examined.
CONCLUSION


Dapagliflozin had a small effect on SBP in patients with HFrEF and was superior to placebo in improving outcomes, and well tolerated, across the range of SBP included in DAPA-HF.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov NCT03036124.",2020,"Dapagliflozin had a small effect on SBP in patients with HFrEF and was superior to placebo in improving outcomes, and well tolerated, across the range of SBP included in DAPA-HF.
","['Key inclusion criteria were: New York Heart Association Class II-IV, left ventricular ejection fraction ≤ 40%, elevated N-terminal pro-B-type natriuretic peptide level, and SBP ≥95\u2009mmHg', 'patients with heart failure and reduced ejection fraction (HFrEF', '1205 patients had a baseline SBP <110\u2009mmHg; 981\u2009≥\u2009110\u2009<\u2009120; 1149\u2009≥\u2009120\u2009<\u2009130; and 1409\u2009≥\u2009130\u2009mmHg']","['Dapagliflozin', 'dapagliflozin', 'dapagliflozin and placebo', 'placebo']","['composite of worsening heart failure or cardiovascular death', 'SBP', 'baseline systolic blood pressure', 'systolic blood pressure']","[{'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0441886', 'cui_str': 'Class 2'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C4274438', 'cui_str': 'Baseline systolic blood pressure'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C4319552', 'cui_str': '130'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C4274438', 'cui_str': 'Baseline systolic blood pressure'}]",1205.0,0.177517,"Dapagliflozin had a small effect on SBP in patients with HFrEF and was superior to placebo in improving outcomes, and well tolerated, across the range of SBP included in DAPA-HF.
","[{'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Serenelli', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, 126 University Place, Glasgow G12 8TA, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Böhm', 'Affiliation': 'Klinik für Innere Medizin III, Universität des Saarlandes, Universitätsklinikum des Saarlandes, Homburg/Saar, Germany.'}, {'ForeName': 'Silvio E', 'Initials': 'SE', 'LastName': 'Inzucchi', 'Affiliation': 'Section of Endocrinology, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Køber', 'Affiliation': 'Department of Cardiology, Rigshospitalet Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Mikhail N', 'Initials': 'MN', 'LastName': 'Kosiborod', 'Affiliation': ""Saint Luke's Mid America Heart Institute and University of Missouri-Kansas City, Kansas City, MO, USA.""}, {'ForeName': 'Felipe A', 'Initials': 'FA', 'LastName': 'Martinez', 'Affiliation': 'National University of Cordoba, Cordoba, Argentina.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Ponikowski', 'Affiliation': 'Department of Heart Diseases, Wroclaw Medical University, Wroclaw, Poland.'}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Sabatine', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'DeMets', 'Affiliation': 'Department of Biostatistics & Medical Informatics, University of Wisconsin, Madison, WI, USA.'}, {'ForeName': 'Olof', 'Initials': 'O', 'LastName': 'Bengtsson', 'Affiliation': 'AstraZeneca R&D, Gothenburg, Sweden.'}, {'ForeName': 'Mikaela', 'Initials': 'M', 'LastName': 'Sjöstrand', 'Affiliation': 'AstraZeneca R&D, Gothenburg, Sweden.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Langkilde', 'Affiliation': 'AstraZeneca R&D, Gothenburg, Sweden.'}, {'ForeName': 'Inder S', 'Initials': 'IS', 'LastName': 'Anand', 'Affiliation': 'Department of Cardiology, University of Minnesota, Minneaspolis, MN, USA.'}, {'ForeName': 'Chern-En', 'Initials': 'CE', 'LastName': 'Chiang', 'Affiliation': 'General Clinical Research Center and Division of Cardiology, Taipei Veterans General Hospital and National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Vijay K', 'Initials': 'VK', 'LastName': 'Chopra', 'Affiliation': 'Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India.'}, {'ForeName': 'Rudolf A', 'Initials': 'RA', 'LastName': 'de Boer', 'Affiliation': 'Department of Cardiology, University Medical Center and University of Groningen, Groningen, Netherlands.'}, {'ForeName': 'Mirta', 'Initials': 'M', 'LastName': 'Diez', 'Affiliation': 'Division of Cardiology, Institute Cardiovascular de Buenos Aires, Buenos Aires, Argentina.'}, {'ForeName': 'Andrej', 'Initials': 'A', 'LastName': 'Dukát', 'Affiliation': 'Department of Internal Medicine, Comenius University in Bratislava, Bratislava, Slovakia.'}, {'ForeName': 'Junbo', 'Initials': 'J', 'LastName': 'Ge', 'Affiliation': 'Department of Cardiology, Shanghai Institute of Cardiovascular Disease and Zhongshan Hospital Fudan University, Shanghai, China.'}, {'ForeName': 'Jonathan G', 'Initials': 'JG', 'LastName': 'Howlett', 'Affiliation': 'Cardiac Sciences and Medicine, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Tzvetana', 'Initials': 'T', 'LastName': 'Katova', 'Affiliation': 'Clinic of Cardiology, National Cardiology Hospital, Sofia, Bulgaria.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Kitakaze', 'Affiliation': 'Cardiovascular Division of Medicine, National Cerebral and Cardiovascular Center, Osaka, Japan.'}, {'ForeName': 'Charlotta E A', 'Initials': 'CEA', 'LastName': 'Ljungman', 'Affiliation': 'Department of Molecular and Clinical Medicine and Cardiology, Sahlgrenska Academy, Gothenburg, Sweden.'}, {'ForeName': 'Subodh', 'Initials': 'S', 'LastName': 'Verma', 'Affiliation': ""Division of Cardiac Surgery, St Michael's Hospital, University of Toronto, ON, Canada.""}, {'ForeName': 'Kieran F', 'Initials': 'KF', 'LastName': 'Docherty', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, 126 University Place, Glasgow G12 8TA, UK.'}, {'ForeName': 'Pardeep S', 'Initials': 'PS', 'LastName': 'Jhund', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, 126 University Place, Glasgow G12 8TA, UK.'}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, 126 University Place, Glasgow G12 8TA, UK.'}]",European heart journal,['10.1093/eurheartj/ehaa496']
2493,32826390,Randomized Controlled Study to Compare Uncovered Stent Versus Covered Stent as Percutaneous Endoprosthesis for Malignant Biliary Obstruction (JIVROSG-0207).,"OBJECTIVES


The objective of this study was to compare the clinical effectiveness of uncovered stent and covered stent as percutaneous endoprosthesis for malignant biliary obstruction of the extrahepatic bile duct.
MATERIALS AND METHODS


After completion of percutaneous internal and external tube placement for unresectable malignant biliary obstruction, 60 patients were registered and randomly assigned in a 1:1 ratio to an uncovered or covered stent group. Metallic stent placement was performed within 1 week after registration, and an external biliary drainage tube was removed >3 days after stent placement. The primary endpoint was the obstructive jaundice-free survival rate at 24 weeks after registration, and the secondary endpoints were the success rate of percutaneous tube removal and adverse events.
RESULTS


The obstructive jaundice-free survival rate at 24 weeks after registration was 13/29 (44.8%, 95% confidence interval [CI]: 28.4%-62.5%) and 15/30 (50.0%, 95% CI: 33.2%-66.8%) in the uncovered and covered stent groups, respectively. The success rate of percutaneous tube removal was 28/29 (96.6%, 95% CI: 82.8%-99.4%) and 30/30 (100%, 95% CI: 90.5%-100%) in the uncovered and covered stent groups, respectively. There were no procedure-related deaths. Twenty-eight adverse events were observed in 21 patients (7 in the uncovered stent group and 14 in the covered stent group).
CONCLUSIONS


There was no significant difference in the obstructive jaundice-free survival rate at 24 weeks between the 2 groups. Considering the technical difficulty and invasiveness of covered stent placement, the placement of covered stents may not be needed in patients with a short prognosis of <24 weeks.",2020,"The success rate of percutaneous tube removal was 28/29 (96.6%, 95% CI: 82.8%-99.4%) and 30/30 (100%, 95% CI: 90.5%-100%) in the uncovered and covered stent groups, respectively.","['Malignant Biliary Obstruction (JIVROSG-0207', 'unresectable malignant biliary obstruction, 60 patients']","['percutaneous internal and external tube placement', 'Metallic stent placement', 'stent and covered stent as percutaneous endoprosthesis', 'Stent Versus Covered Stent as Percutaneous Endoprosthesis']","['success rate of percutaneous tube removal and adverse events', 'procedure-related deaths', 'success rate of percutaneous tube removal', 'adverse events', 'obstructive jaundice-free survival rate']","[{'cui': 'C3898473', 'cui_str': 'Malignant biliary obstruction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0441290', 'cui_str': 'Metal stent'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C4704931', 'cui_str': 'Endoprostheses'}]","[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0022354', 'cui_str': 'Obstructive hyperbilirubinemia'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",60.0,0.277076,"The success rate of percutaneous tube removal was 28/29 (96.6%, 95% CI: 82.8%-99.4%) and 30/30 (100%, 95% CI: 90.5%-100%) in the uncovered and covered stent groups, respectively.","[{'ForeName': 'Yasuyuki', 'Initials': 'Y', 'LastName': 'Onishi', 'Affiliation': 'Department of Diagnostic Radiology, National Cancer Center Hospital, Tokyo.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Yoshioka', 'Affiliation': 'Department of Radiology, Nishinara Central Hospital.'}, {'ForeName': 'Yasuaki', 'Initials': 'Y', 'LastName': 'Arai', 'Affiliation': 'Department of Diagnostic Radiology, National Cancer Center Hospital, Tokyo.'}, {'ForeName': 'Yoshitaka', 'Initials': 'Y', 'LastName': 'Inaba', 'Affiliation': 'Department of Diagnostic and Interventional Radiology, Aichi Cancer Center Hospital, Aichi.'}, {'ForeName': 'Hiroya', 'Initials': 'H', 'LastName': 'Saito', 'Affiliation': 'Department of Radiology, Sapporo Higashi Tokushukai Hospital, Hokkaido.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Aramaki', 'Affiliation': 'Division of Interventional Radiology, Shizuoka Cancer Center, Shizuoka, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Anai', 'Affiliation': 'Department of Radiology, Nara Medical University, Nara.'}, {'ForeName': 'Miyuki', 'Initials': 'M', 'LastName': 'Sone', 'Affiliation': 'Department of Diagnostic Radiology, National Cancer Center Hospital, Tokyo.'}]",American journal of clinical oncology,['10.1097/COC.0000000000000750']
2494,32824920,Can Creatine Supplementation Interfere with Muscle Strength and Fatigue in Brazilian National Level Paralympic Powerlifting?,"The aim of the present study was to analyze the effect of creatine (Cr) supplementation on peak torque (PT) and fatigue rate in Paralympic weightlifting athletes. Eight Paralympic powerlifting athletes participated in the study, with 25.40 ± 3.30 years and 70.30 ± 12.15 kg. The measurements of muscle strength, fatigue index (FI), peak torque (PT), force (kgf), force (N), rate of force development (RFD), and time to maximum isometric force (time) were determined by a Musclelab load cell. The study was performed in a single-blind manner, with subjects conducting the experiments first with placebo supplementation and then, following a 7-day washout period, beginning the same protocol with creatine supplementation for 7 days. This sequence was chosen because of the lengthy washout of creatine. Regarding the comparison between conditions, Cr supplementation did not show effects on the variables of muscle force, peak torque, RFD, and time to maximum isometric force ( p  > 0.05). However, when comparing the results of the moments with the use of Cr and placebo, a difference was observed for the FI after seven days (U 3 : 1.12; 95% CI: (0.03, 2.27);  p  = 0.02); therefore, the FI was higher for placebo. Creatine supplementation has a positive effect on the performance of Paralympic powerlifting athletes, reducing fatigue index, and keeping the force levels as well as PT.",2020,"Regarding the comparison between conditions, Cr supplementation did not show effects on the variables of muscle force, peak torque, RFD, and time to maximum isometric force ( p  > 0.05).","['Paralympic weightlifting athletes', 'Eight Paralympic powerlifting athletes participated in the study, with 25.40 ± 3.30 years and 70.30 ± 12.15 kg']","['placebo', 'Creatine supplementation', 'creatine (Cr) supplementation', 'placebo supplementation']","['muscle strength, fatigue index (FI), peak torque (PT), force (kgf), force (N), rate of force development (RFD), and time to maximum isometric force (time', 'muscle force, peak torque, RFD, and time to maximum isometric force', 'peak torque (PT) and fatigue rate']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0010286', 'cui_str': 'Creatine'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}]",,0.0998311,"Regarding the comparison between conditions, Cr supplementation did not show effects on the variables of muscle force, peak torque, RFD, and time to maximum isometric force ( p  > 0.05).","[{'ForeName': 'Carlos Rodrigo', 'Initials': 'CR', 'LastName': 'Soares Freitas Sampaio', 'Affiliation': 'Group of Studies and Research of Performance, Sport, Health and Paralympic Sports (GPEPS), Federal University of Sergipe (UFS), São Cristovão 49100-000, Sergipe, Brazil.'}, {'ForeName': 'Felipe J', 'Initials': 'FJ', 'LastName': 'Aidar', 'Affiliation': 'Group of Studies and Research of Performance, Sport, Health and Paralympic Sports (GPEPS), Federal University of Sergipe (UFS), São Cristovão 49100-000, Sergipe, Brazil.'}, {'ForeName': 'Alexandre R P', 'Initials': 'ARP', 'LastName': 'Ferreira', 'Affiliation': 'College of Physical Education and Exercise Science, University of Brasília (UnB), Brasília 70910-900, Brazil.'}, {'ForeName': 'Jymmys Lopes Dos', 'Initials': 'JLD', 'LastName': 'Santos', 'Affiliation': 'Program in Biotechnology, Northeast Network in Biotechnology (RENORBIO), Federal University of Sergipe (UFS), São Cristovão 49100-000, Sergipe, Brazil.'}, {'ForeName': 'Anderson Carlos', 'Initials': 'AC', 'LastName': 'Marçal', 'Affiliation': 'Group of Studies and Research of Performance, Sport, Health and Paralympic Sports (GPEPS), Federal University of Sergipe (UFS), São Cristovão 49100-000, Sergipe, Brazil.'}, {'ForeName': 'Dihogo Gama de', 'Initials': 'DG', 'LastName': 'Matos', 'Affiliation': 'Group of Studies and Research of Performance, Sport, Health and Paralympic Sports (GPEPS), Federal University of Sergipe (UFS), São Cristovão 49100-000, Sergipe, Brazil.'}, {'ForeName': 'Raphael Fabrício de', 'Initials': 'RF', 'LastName': 'Souza', 'Affiliation': 'Group of Studies and Research of Performance, Sport, Health and Paralympic Sports (GPEPS), Federal University of Sergipe (UFS), São Cristovão 49100-000, Sergipe, Brazil.'}, {'ForeName': 'Osvaldo Costa', 'Initials': 'OC', 'LastName': 'Moreira', 'Affiliation': 'Institute of Biological Sciences and Health, Federal University of Viçosa, Campus Florestal, Minas Gerais 35690-000, Brazil.'}, {'ForeName': 'Ialuska', 'Initials': 'I', 'LastName': 'Guerra', 'Affiliation': 'Federal Institute of Education, Science and Technology of Ceará (IFCE), Campus of Juazeiro do Norte, Ceará 63040-540, Brazil.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Fernandes Filho', 'Affiliation': 'Brazilian Paralympic Academy, Brazilian Paralympic Committee, São Paulo 04329-000, SP, Brazil.'}, {'ForeName': 'Lucas Soares', 'Initials': 'LS', 'LastName': 'Marcucci-Barbosa', 'Affiliation': 'Laboratory of Inflammation and Exercise Immunology, Sports Center, Physical Education Scholl, Federal University of OuroPreto (UFOP), OuroPreto, Minas Gerais 35400-000, Brazil.'}, {'ForeName': 'Albená', 'Initials': 'A', 'LastName': 'Nunes-Silva', 'Affiliation': 'Laboratory of Inflammation and Exercise Immunology, Sports Center, Physical Education Scholl, Federal University of OuroPreto (UFOP), OuroPreto, Minas Gerais 35400-000, Brazil.'}, {'ForeName': 'Paulo Francisco de', 'Initials': 'PF', 'LastName': 'Almeida-Neto', 'Affiliation': 'Department of Physical Education, Federal University of Rio Grande do Norte (UFRN), Natal, Rio Grande do Norte 59078-970, Brazil.'}, {'ForeName': 'Breno Guilherme Araújo Tinoco', 'Initials': 'BGAT', 'LastName': 'Cabral', 'Affiliation': 'Department of Physical Education, Federal University of Rio Grande do Norte (UFRN), Natal, Rio Grande do Norte 59078-970, Brazil.'}, {'ForeName': 'Victor Machado', 'Initials': 'VM', 'LastName': 'Reis', 'Affiliation': 'Research Center in Sports Sciences, Health Sciences and Human Development (CIDESD), Trásos Montes and Alto Douro University, 5001-801 Vila Real, Portugal.'}]",Nutrients,['10.3390/nu12092492']
2495,32840297,Blood pressure and brain injury in cardiac surgery: a secondary analysis of a randomized trial.,"OBJECTIVES


Brain dysfunction is a serious complication after cardiac surgery. In the Perfusion Pressure Cerebral Infarcts trial, we allocated cardiac surgery patients to a mean arterial pressure of either 70-80 or 40-50 mmHg during cardiopulmonary bypass (CPB). In this secondary analysis, we compared selected cerebral metabolites using magnetic resonance spectroscopy hypothesizing that a postoperative decrease in occipital grey matter (GM) N-acetylaspartate-to-total-creatine ratio, indicative of ischaemic injury, would be found in the high-target group.
METHODS


Of the 197 patients randomized in the Perfusion Pressure Cerebral Infarcts trial, 55 and 42 patients had complete and useful data from GM and white matter (WM), respectively. Spectroscopies were done preoperatively and on postoperative days 3-6. Cognitive function was assessed prior to surgery, at discharge and at 3 months. We predefined the statistical significance level to be 0.01.
RESULTS


A postoperative decrease was found in GM N-acetylaspartate-to-total-creatine ratio in the high-target group [mean difference -0.09 (95% confidence interval -0.14 to -0.04), P = 0.014]. No significant differences were found in other metabolite ratios investigated in GM or WM. No significant association was found between changes in metabolite ratios and new cerebral infarcts, WM lesion score or cognitive dysfunction.
CONCLUSIONS


A higher mean arterial pressure during CPB was associated with signs of impaired cerebral metabolism, though not at the predefined significance level of 0.01. No significant association was found between metabolite ratio changes and neuroradiological pathology or change in cognitive function.
CLINICAL TRIAL REGISTRATION NUMBER


Clinicaltrials.gov: NCT02185885.",2020,"A higher mean arterial pressure during CPB was associated with signs of impaired cerebral metabolism, though not at the predefined significance level of 0.01.","['cardiac surgery', 'cardiac surgery patients to a mean arterial pressure of either 70-80 or 40-50\u2009mmHg during cardiopulmonary bypass (CPB', 'Of the 197 patients randomized in the Perfusion Pressure Cerebral Infarcts trial, 55 and 42 patients had complete and useful data from GM and white matter (WM), respectively']",[],"['metabolite ratios and new cerebral infarcts, WM lesion score or cognitive dysfunction', 'GM N-acetylaspartate-to-total-creatine ratio', 'Blood pressure and brain injury', 'Cognitive function', 'metabolite ratio changes and neuroradiological pathology or change in cognitive function', 'occipital grey matter (GM) N-acetylaspartate-to-total-creatine ratio, indicative of ischaemic injury', 'metabolite ratios', 'mean arterial pressure']","[{'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0007785', 'cui_str': 'Cerebral infarction'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0018220', 'cui_str': 'Grey Matter'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}]",[],"[{'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0007785', 'cui_str': 'Cerebral infarction'}, {'cui': 'C2752009', 'cui_str': 'White matter lesion'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0018220', 'cui_str': 'Grey Matter'}, {'cui': 'C0067684', 'cui_str': 'N-acetyl-L-aspartate'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0010286', 'cui_str': 'Creatine'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0270611', 'cui_str': 'Brain injury'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}]",197.0,0.331603,"A higher mean arterial pressure during CPB was associated with signs of impaired cerebral metabolism, though not at the predefined significance level of 0.01.","[{'ForeName': 'Anne G', 'Initials': 'AG', 'LastName': 'Vedel', 'Affiliation': 'D epartment of Cardiothoracic Anaesthesiology, Heart Center, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Frederik', 'Initials': 'F', 'LastName': 'Holmgaard', 'Affiliation': 'D epartment of Cardiothoracic Anaesthesiology, Heart Center, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Else R', 'Initials': 'ER', 'LastName': 'Danielsen', 'Affiliation': 'D epartment of Radiology, Diagnostic Center, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Annika', 'Initials': 'A', 'LastName': 'Langkilde', 'Affiliation': 'D epartment of Radiology, Diagnostic Center, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Olaf B', 'Initials': 'OB', 'LastName': 'Paulson', 'Affiliation': 'Neurobiology Research Unit, Neuroscience Center, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Hanne B', 'Initials': 'HB', 'LastName': 'Ravn', 'Affiliation': 'D epartment of Cardiothoracic Anaesthesiology, Heart Center, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Lars S', 'Initials': 'LS', 'LastName': 'Rasmussen', 'Affiliation': 'D epartment of Anaesthesia, Center of Head and Orthopedics, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jens C', 'Initials': 'JC', 'LastName': 'Nilsson', 'Affiliation': 'D epartment of Cardiothoracic Anaesthesiology, Heart Center, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}]",European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery,['10.1093/ejcts/ezaa216']
2496,32833606,Correction to: Impact of Goal-Directed Therapy on Delayed Ischemia After Aneurysmal Subarachnoid Hemorrhage: Randomized Controlled Trial.,,2020,,['After Aneurysmal Subarachnoid Hemorrhage'],['Goal-Directed Therapy'],['Delayed Ischemia'],"[{'cui': 'C0751530', 'cui_str': 'Subarachnoid Hemorrhage, Aneurysmal'}]","[{'cui': 'C1271494', 'cui_str': 'Goal directed therapy'}]","[{'cui': 'C0022116', 'cui_str': 'Ischemia'}]",,0.271616,,[],Stroke,['10.1161/STR.0000000000000348']
2497,31645648,A six-gene leukemic stem cell score identifies high risk pediatric acute myeloid leukemia.,"Recently, mRNA-expression signature enriched in LSCs was used to create a 17-gene leukemic stem cell (LSC17) score predictive of prognosis in adult AML. By fitting a Cox-LASSO regression model to the clinical outcome and gene-expression levels of LSC enriched genes in 163 pediatric participants of the AML02 multi-center clinical trial (NCT00136084), we developed a six-gene LSC score of prognostic value in pediatric AML (pLSC6). In the AML02 cohort, the 5-year event-free survival (EFS) of patients within low-pLSC6 group (n = 97) was 78.3 (95% CI = 70.5-86.9%) as compared with 34.5(95% CI = 24.7-48.2 %) in patients within high-pLSC6 group (n = 66 subjects), p < 0.00001. pLSC6 remained significantly associated with EFS and overall survival (OS) after adjusting for induction 1-MRD status, risk-group, FLT3-status, WBC-count at diagnosis and age. pLSC6 formula developed in the AML02 cohort was validated in the pediatric AML-TARGET project data (n = 205), confirming its prognostic value in both single-predictor and multiple-predictor Cox regression models. In both cohorts, pLSC6 predicted outcome of transplant patients, suggesting it as a useful criterion for transplant referrals. Our results suggest that pLSC6 score holds promise in redefining initial risk-stratification and identifying poor risk AML thereby providing guidance for developing novel treatment strategies.",2020,"pLSC6 remained significantly associated with EFS and overall survival (OS) after adjusting for induction 1-MRD status, risk-group, FLT3-status, WBC-count at diagnosis and age.","['risk pediatric acute myeloid leukemia', '163 pediatric participants']",['pLSC6'],"['EFS and overall survival (OS', '5-year event-free survival (EFS']","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}]",[],"[{'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0439234', 'cui_str': 'year'}]",163.0,0.0725067,"pLSC6 remained significantly associated with EFS and overall survival (OS) after adjusting for induction 1-MRD status, risk-group, FLT3-status, WBC-count at diagnosis and age.","[{'ForeName': 'Abdelrahman H', 'Initials': 'AH', 'LastName': 'Elsayed', 'Affiliation': 'Department of Pharmacotherapy and Translational Research, College of Pharmacy, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Roya', 'Initials': 'R', 'LastName': 'Rafiee', 'Affiliation': 'Department of Pharmacotherapy and Translational Research, College of Pharmacy, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Xueyuan', 'Initials': 'X', 'LastName': 'Cao', 'Affiliation': ""Department of Biostatistics, St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Raimondi', 'Affiliation': ""Department of Pathology, St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Downing', 'Affiliation': ""Department of Pathology, St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Raul', 'Initials': 'R', 'LastName': 'Ribeiro', 'Affiliation': ""Department of Oncology, St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Yiping', 'Initials': 'Y', 'LastName': 'Fan', 'Affiliation': ""Department of Biostatistics, St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Tanja A', 'Initials': 'TA', 'LastName': 'Gruber', 'Affiliation': ""Department of Pathology, St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Sharyn', 'Initials': 'S', 'LastName': 'Baker', 'Affiliation': 'Department of Pharmaceutics and Pharmaceutical Chemistry, College of Pharmacy, The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Jeffery', 'Initials': 'J', 'LastName': 'Klco', 'Affiliation': ""Department of Pathology, St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Jeffrey E', 'Initials': 'JE', 'LastName': 'Rubnitz', 'Affiliation': ""Department of Oncology, St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Pounds', 'Affiliation': ""Department of Biostatistics, St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Jatinder K', 'Initials': 'JK', 'LastName': 'Lamba', 'Affiliation': 'Department of Pharmacotherapy and Translational Research, College of Pharmacy, University of Florida, Gainesville, FL, USA. jlamba@cop.ufl.edu.'}]",Leukemia,['10.1038/s41375-019-0604-8']
2498,32843164,"Fixed-dose combination of indacaterol/glycopyrronium/mometasone furoate once-daily versus salmeterol/fluticasone twice-daily plus tiotropium once-daily in patients with uncontrolled asthma: A randomised, Phase IIIb, non-inferiority study (ARGON).","BACKGROUND


The efficacy and safety of once-daily (o.d.) fixed-dose combination of indacaterol (IND), glycopyrronium (GLY) and mometasone furoate (MF) via Breezhaler® versus concurrent administration of salmeterol/fluticasone (SAL/FLU) twice-daily (b.i.d.) via Accuhaler®+Tiotropium (TIO) o.d. via Respimat® was evaluated in patients with uncontrolled asthma.
METHODS


Patients (aged ≥18 years), symptomatic (Asthma Control Questionnaire [ACQ]-7 ≥1.5) despite treatment with long-acting β 2 -agonist/inhaled corticosteroid medium- or high-dose, received IND/GLY/MF high- (150/50/160 μg) or medium-dose (150/50/80 μg) o.d. or SAL/FLU high-dose (50/500 μg) b.i.d.+Tio 5 μg o.d. for 24 weeks. The primary objective was to confirm the non-inferiority of either dose of IND/GLY/MF to SAL/FLU high dose + TIO in terms of Asthma Quality of Life Questionnaire (AQLQ). Additional endpoints: ACQ-7, lung function, health status (St George's Respiratory Questionnaire [SGRQ]), exacerbations, and safety after 24 weeks.
RESULTS


IND/GLY/MF high- and medium-dose met the primary endpoint, confirming non-inferiority to SAL/FLU high dose + TIO for AQLQ (least square mean treatment difference [Δ]: 0.073 and -0.038, respectively; both p < 0.001). IND/GLY/MF high-dose improved ACQ-7 (Δ: -0.124; p = 0.004), trough FEV 1  (Δ: 96 mL; p < 0.001), peak expiratory flow (morning [Δ: 9.56 L/min; p = 0.005], evening [Δ: 9.15 L/min; p = 0.006]) and SGRQ (Δ: -2.00; p = 0.04) versus SAL/FLU high dose + TIO. Improvements in these endpoints were comparable for IND/GLY/MF medium-dose and SAL/FLU high dose + TIO. Adverse events were generally comparable across treatments.
CONCLUSIONS


IND/GLY/MF high- and medium-dose o.d. via a single inhaler were non-inferior to SAL/FLU high-dose b.i.d. + TIO o.d. via two inhalers for AQLQ. IND/GLY/MF high-dose o.d. improved lung function, asthma control and health status versus SAL/FLU high dose + TIO, while IND/GLY/MF medium-dose had comparable efficacy but at a corresponding lower steroid dose.",2020,Improvements in these endpoints were comparable for IND/GLY/MF medium-dose and SAL/FLU high dose + TIO.,"['Patients (aged ≥18 years), symptomatic (Asthma Control Questionnaire [ACQ]-7 ≥1.5) despite treatment with long-acting β 2 -agonist/inhaled corticosteroid medium- or high-dose, received IND/GLY/MF high', 'patients with uncontrolled asthma']","['indacaterol/glycopyrronium/mometasone furoate', 'salmeterol/fluticasone twice-daily plus tiotropium', 'indacaterol (IND), glycopyrronium (GLY) and mometasone furoate (MF) via Breezhaler®', 'salmeterol/fluticasone (SAL/FLU) twice-daily (b.i.d.) via Accuhaler®+Tiotropium (TIO', 'b.i.d.+Tio 5\xa0μg']","['Asthma Quality of Life Questionnaire (AQLQ', 'Adverse events', 'GLY/MF high-dose improved ACQ-7', ""ACQ-7, lung function, health status (St George's Respiratory Questionnaire [SGRQ]), exacerbations, and safety after 24 weeks"", 'peak expiratory flow', 'improved lung function, asthma control and health status']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C2919686', 'cui_str': 'Asthma control questionnaire'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C1722260', 'cui_str': 'indacaterol'}, {'cui': 'C3814772', 'cui_str': 'glycopyrronium'}, {'cui': 'C0066700', 'cui_str': 'Mometasone furoate'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}]","[{'cui': 'C1722260', 'cui_str': 'indacaterol'}, {'cui': 'C3814772', 'cui_str': 'glycopyrronium'}, {'cui': 'C0066700', 'cui_str': 'Mometasone furoate'}, {'cui': 'C0073992', 'cui_str': 'salmeterol'}, {'cui': 'C0082607', 'cui_str': 'fluticasone'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0213771', 'cui_str': 'tiotropium'}]","[{'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3814772', 'cui_str': 'glycopyrronium'}, {'cui': 'C0066700', 'cui_str': 'Mometasone furoate'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C2919686', 'cui_str': 'Asthma control questionnaire'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",,0.202799,Improvements in these endpoints were comparable for IND/GLY/MF medium-dose and SAL/FLU high dose + TIO.,"[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Gessner', 'Affiliation': 'Universitätsklinikum Leipzig, Germany POIS Leipzig GbR, Leipzig, Germany. Electronic address: studien@pois-le.de.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Kornmann', 'Affiliation': 'IKF Pneumologie Frankfurt, Clinical Research Centre Respiratory Diseases, Frankfurt, Germany.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Maspero', 'Affiliation': 'Allergy and Respiratory Research Unit, Fundación CIDEA, Buenos Aires, Argentina.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'van Zyl-Smit', 'Affiliation': 'Division of Pulmonology and UCT Lung Institute, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Krüll', 'Affiliation': 'Institut für Allergie- und Asthmaforschung Berlin, IAAB, Germany.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Salina', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Pritam', 'Initials': 'P', 'LastName': 'Gupta', 'Affiliation': 'Novartis Healthcare Pvt. Ltd, Hyderabad, India.'}, {'ForeName': 'Sebastien', 'Initials': 'S', 'LastName': 'Bostel', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Fucile', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, United States.'}, {'ForeName': 'Lorena Garcia', 'Initials': 'LG', 'LastName': 'Conde', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Pfister', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}]",Respiratory medicine,['10.1016/j.rmed.2020.106021']
2499,32807539,Medication Education for Dosing Safety: A Randomized Controlled Trial.,"STUDY OBJECTIVE


This study sought to determine whether a brief intervention at the time of emergency department (ED) discharge can improve safe dosing of liquid acetaminophen and ibuprofen by parents or guardians.
METHODS


We performed a randomized controlled trial in the ED of parents and guardians of children 90 days to 11.9 years of age who were discharged with acetaminophen or ibuprofen, or both. Families were randomized to standard care or a teaching intervention combining lay language, simplified handouts, provision of an unmarked dosing syringe, and teach-back to confirm correct dosing. Participants were called 48 to 72 hours and 5 to 7 days after ED discharge to assess understanding of correct dosing. The primary outcome was defined as parent or guardian report of safe dosing at the time of first follow-up call. Our primary hypothesis was that the intervention would decrease the rate of error from 30% to 10% at 48- to 72-hour follow-up.
RESULTS


We enrolled 149 of 259 (58%) eligible subjects; 97 of 149 (65%) were reached at first follow-up call, of whom 35 of 97 (36%) received the intervention. Among those participants receiving the intervention, 25 of 35 (71%) were able to identify a safe dose for their child at the time of the first call compared with 28 of 62 (45%) of those in the control arm. The difference in proportions was 26% (95% confidence interval [CI] 7% to 46%). There was a 58% increase in reporting safe dosing in the intervention group compared with the control roup (relative risk 1.58; 95% CI 1.12 to 2.24), and it remained significant after adjustment for health literacy and language (adjusted relative risk 1.50; 95% CI 1.06 to 2.13).
CONCLUSIONS


A multifaceted intervention at the time of ED discharge-consisting of a simplified dosing handout, a teaching session, teach-back, and provision of a standardized dosing device-can improve parents' knowledge of safe dosing of liquid medications at 48 to 72 hours.",2020,"There was a 58% increase in reporting safe dosing in the intervention group compared with the control roup (relative risk 1.58; 95% CI 1.12 to 2.24), and it remained significant after adjustment for health literacy and language (adjusted relative risk 1.50; 95% CI 1.06 to 2.13).
","['by parents or guardians', 'We enrolled 149 of 259 (58%) eligible subjects; 97 of 149 (65%) were reached at first follow-up call, of whom 35 of 97 (36%) received the intervention', 'parents and guardians of children 90 days to 11.9 years of age who were discharged with', ' or both']","['acetaminophen or ibuprofen', 'standard care or a teaching intervention combining lay language, simplified handouts, provision of an unmarked dosing syringe, and teach-back to confirm correct dosing', 'liquid acetaminophen and ibuprofen']","['health literacy and language', 'rate of error', 'reporting safe dosing', 'parent or guardian report of safe dosing at the time of first follow-up call']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0023226', 'cui_str': 'Legal guardian'}, {'cui': 'C5191071', 'cui_str': '149'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}]","[{'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0023668', 'cui_str': 'Liechtenstein'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0039142', 'cui_str': 'Syringe'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}]","[{'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0023226', 'cui_str': 'Legal guardian'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]",149.0,0.136961,"There was a 58% increase in reporting safe dosing in the intervention group compared with the control roup (relative risk 1.58; 95% CI 1.12 to 2.24), and it remained significant after adjustment for health literacy and language (adjusted relative risk 1.50; 95% CI 1.06 to 2.13).
","[{'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Naureckas Li', 'Affiliation': ""Division of Pediatric Infectious Diseases, Boston Children's Hospital, Boston, MA. Electronic address: caitlin.li@childrens.harvard.edu.""}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Camargo', 'Affiliation': 'Department of Emergency Medicine, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Faridi', 'Affiliation': 'Department of Emergency Medicine, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Janice A', 'Initials': 'JA', 'LastName': 'Espinola', 'Affiliation': 'Department of Emergency Medicine, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Bryan D', 'Initials': 'BD', 'LastName': 'Hayes', 'Affiliation': 'Department of Emergency Medicine, Massachusetts General Hospital, Boston, MA; Department of Pharmacy, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Porter', 'Affiliation': ""Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH; Division of Emergency Medicine, Cincinnati Children's Hospital, Cincinnati, OH.""}, {'ForeName': 'Ari', 'Initials': 'A', 'LastName': 'Cohen', 'Affiliation': 'Department of Emergency Medicine, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Samuels-Kalow', 'Affiliation': 'Department of Emergency Medicine, Massachusetts General Hospital, Boston, MA.'}]",Annals of emergency medicine,['10.1016/j.annemergmed.2020.07.007']
2500,32807632,Effects of cognitive behavioral therapy on sleep disturbances and quality of life among adults with type 2 diabetes mellitus: A randomized controlled trial.,"BACKGROUND AND AIMS


Cognitive behavioral therapy (CBT) is recommended as the first-line nonpharmacotherapy for sleep complaints. However, there are no studies that tested CBT for improving sleep quality and increasing quality of life (QOL) in patients with type 2 diabetes mellitus (T2DM). Therefore, this study aims to test the effect of CBT on sleep disturbances and QOL in patients with T2DM.
METHODS AND RESULTS


In total, 187 participants with T2DM and comorbid poor sleep quality were included in the analysis with the control group of 93 receiving usual care (UC) only and the intervention group of 94 receiving CBT with aerobic exercise plus UC, The Pittsburgh Sleep Quality Index (PSQI), the Diabetes-Specific Quality of Life Scale (DSQLS) and the glycated hemoglobin (HbA1C) values were collected at baseline, after the 2-month intervention, and 6 months of follow-up. The CBT group had 3.03 points lower PSQI scores (95% confidence interval [CI]: 2.07-4.00, P < 0.001) and 7.92 points lower total DSQLS scores (95% CI: 4.98-10.87, P < 0.001) than the control group after 6-month follow-up. No difference was found in HbAlc between the two groups (t = -0.47, P = 0.64) after 2-month intervention, while the CBT group had 0.89 units lower HbAlc (95% CI: 0.49-1.28, P < 0.001) than the control group after 6-month follow-up.
CONCLUSION


CBT is effective for sleep disturbances and can also improve sleep quality, increase QOL, and decrease glycemic levels in participants with T2DM.
TRIAL REGISTRATION


Chinese Clinical Trials Registration (Practical study of the appropriate technique for improvement of quality of life of the patients with type 2 diabetes in communities: ChiCTR-IOP-16008045).",2020,"The CBT group had 3.03 points lower PSQI scores (95% confidence interval [CI]: 2.07-4.00, P < 0.001) and 7.92 points lower total DSQLS scores (95% CI: 4.98-10.87, P < 0.001) than the control group after 6-month follow-up.","['187 participants with T2DM and comorbid poor sleep quality were included in the analysis with the control group of 93 receiving usual care (UC) only and the intervention group of 94 receiving', 'adults with type 2 diabetes mellitus', 'participants with T2DM', 'patients with type 2 diabetes mellitus (T2DM', 'patients with T2DM', 'patients with type 2 diabetes in communities']","['Cognitive behavioral therapy (CBT', 'CBT', 'cognitive behavioral therapy', 'CBT with aerobic exercise plus UC']","['glycemic levels', 'quality of life', 'sleep disturbances and QOL', 'PSQI scores', 'Pittsburgh Sleep Quality Index (PSQI), the Diabetes-Specific Quality of Life Scale (DSQLS) and the glycated hemoglobin (HbA1C) values', 'quality of life (QOL', 'total DSQLS scores', 'sleep disturbances and quality of life', 'sleep quality, increase QOL', 'sleep quality', 'HbAlc']","[{'cui': 'C4517618', 'cui_str': '187'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0235162', 'cui_str': 'Difficulty sleeping'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C4545801', 'cui_str': 'Pittsburgh Sleep Quality Index score'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",187.0,0.0901047,"The CBT group had 3.03 points lower PSQI scores (95% confidence interval [CI]: 2.07-4.00, P < 0.001) and 7.92 points lower total DSQLS scores (95% CI: 4.98-10.87, P < 0.001) than the control group after 6-month follow-up.","[{'ForeName': 'Xiaowei', 'Initials': 'X', 'LastName': 'Zuo', 'Affiliation': ""Department of Psychiatry, Xuzhou Oriental People's Hospital, 379 Tongshan Road, Xuzhou, Jiangsu, 221004, China. Electronic address: 2783369510@qq.com.""}, {'ForeName': 'Zongmei', 'Initials': 'Z', 'LastName': 'Dong', 'Affiliation': 'Department of Control and Prevention of Chronic Non-Communicable Diseases, Xuzhou Center for Disease Control and Prevention, 142 West Erhuan Road, Xuzhou, Jiangsu, 221006, China. Electronic address: dzm1001@126.com.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': ""Department of Psychiatry, Xuzhou Oriental People's Hospital, 379 Tongshan Road, Xuzhou, Jiangsu, 221004, China. Electronic address: 11754214@qq.com.""}, {'ForeName': 'Pan', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Department of Control and Prevention of Chronic Non-Communicable Diseases, Xuzhou Center for Disease Control and Prevention, 142 West Erhuan Road, Xuzhou, Jiangsu, 221006, China. Electronic address: xzzhangpan@126.com.'}, {'ForeName': 'Guiqiu', 'Initials': 'G', 'LastName': 'Chang', 'Affiliation': 'Department of Control and Prevention of Chronic Non-Communicable Diseases, Xuzhou Center for Disease Control and Prevention, 142 West Erhuan Road, Xuzhou, Jiangsu, 221006, China. Electronic address: 1548857561@qq.com.'}, {'ForeName': 'Quanyong', 'Initials': 'Q', 'LastName': 'Xiang', 'Affiliation': 'Department of Non-Communicable Disease Control, Jiangsu Provincial Center for Disease Control and Prevention, 172 Jiangsu Road, Nanjing, Jiangsu, 210009, China. Electronic address: quanyongxiang@vip.sina.com.'}, {'ForeName': 'Xianghua', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': ""Department of Psychiatry, Xuzhou Oriental People's Hospital, 379 Tongshan Road, Xuzhou, Jiangsu, 221004, China. Electronic address: 610492837@qq.com.""}, {'ForeName': 'Jinyi', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Department of Non-Communicable Disease Control, Jiangsu Provincial Center for Disease Control and Prevention, 172 Jiangsu Road, Nanjing, Jiangsu, 210009, China. Electronic address: 158694402@qq.com.'}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Qiao', 'Affiliation': 'Department of Control and Prevention of Chronic Non-Communicable Diseases, Xuzhou Center for Disease Control and Prevention, 142 West Erhuan Road, Xuzhou, Jiangsu, 221006, China.'}, {'ForeName': 'Yongjie', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': ""Department of Psychiatry, Xuzhou Oriental People's Hospital, 379 Tongshan Road, Xuzhou, Jiangsu, 221004, China. Electronic address: yyand4824@hotmail.com.""}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Qin', 'Affiliation': 'Department of Non-Communicable Disease Control, Jiangsu Provincial Center for Disease Control and Prevention, 172 Jiangsu Road, Nanjing, Jiangsu, 210009, China. Electronic address: qinyu@jscdc.cn.'}, {'ForeName': 'Peian', 'Initials': 'P', 'LastName': 'Lou', 'Affiliation': 'Department of Control and Prevention of Chronic Non-Communicable Diseases, Xuzhou Center for Disease Control and Prevention, 142 West Erhuan Road, Xuzhou, Jiangsu, 221006, China. Electronic address: lpa82835415@126.com.'}]","Nutrition, metabolism, and cardiovascular diseases : NMCD",['10.1016/j.numecd.2020.06.024']
2501,32811738,"A single one-minute, comfortable paced, stair-climbing bout reduces postprandial glucose following a mixed meal.","BACKGROUND AND AIMS


Postprandial blood glucose (PBG) is an independent predictor of disease and mortality risk. To date, the shortest, single, moderate-intensity exercise intervention to reduce PBG is a 1 min bout of stair stepping during an oral glucose tolerance test. Whether this effect translates to real meal consumption is unknown.
METHODS AND RESULTS


Subjects (N = 30) participated in a randomized controlled crossover trial performing 0 min (seated control), 1 min, 3 min or 10 min of stair climbing and descending bouts (SCD) at a self-selected pace after consumption of a mixed meal on four separate visits. Compared to control, all SCD reduced PBG at least one timepoint: at 30-min the 3 min (-10.8 (-18.7 to -2.8) mg/dL, p = 0.010) and 10 min (-36.3 (-46.4 to -26.3) mg/dL), p < .001), and at 45-min the 1 min (-7.3 (-13.9 to -0.7) mg/dL, p = 0.030, 3 min (-8.7 (-13.9 to -3.6) mg/dL, p = 0.002 and 10 min SCD (-12.2 (-18.2 to -6.1)mg/dL, p < 0.000) reduced PBG. The area under the curve (AUC) for PBG was lower following the 3 min (-4.4% (-7.5 to -1.4%), p = 0.006) and 10 min (-8.9% (-12.4 to -5.3%), p < 0.001), while the incremental AUC (iAUC) was reduced only following the 10 min (-38.0% (-63.7 to -12.3%), p = 0.005) SCD. All SCD were rated by subjects as very light to light intensity.
CONCLUSIONS


Single, subjectively ""light"" intensity stair climbing and descending bouts as short as 1 min in duration attenuate the postprandial glucose response in normal weight individuals following consumption of a mixed meal. More pronounced effects require longer bouts in a dose-dependent manner.",2020,"The area under the curve (AUC) for PBG was lower following the 3 min (-4.4% (-7.5 to -1.4%), p = 0.006) and 10 min (-8.9% (-12.4 to -5.3%), p < 0.001), while the incremental AUC (iAUC) was reduced only following the 10 min (-38.0% (-63.7 to -12.3%), p = 0.005)",['Subjects (N\xa0=\xa030'],"['0 min (seated control), 1\xa0min, 3\xa0min or 10\xa0min of stair climbing and descending bouts (SCD) at a self-selected pace after consumption of a mixed meal on four separate visits']","['Postprandial blood glucose (PBG', 'SCD', 'SCD reduced PBG', 'PBG', 'postprandial glucose', 'area under the curve (AUC) for PBG', 'incremental AUC (iAUC']",[],"[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0277814', 'cui_str': 'Sitting position'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1290942', 'cui_str': 'Climbing stairs'}, {'cui': 'C0205386', 'cui_str': 'Descending'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0287990', 'cui_str': 'Furin'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0443299', 'cui_str': 'Separate'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0002895', 'cui_str': 'Sickling disorder due to hemoglobin S'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}]",30.0,0.0429009,"The area under the curve (AUC) for PBG was lower following the 3 min (-4.4% (-7.5 to -1.4%), p = 0.006) and 10 min (-8.9% (-12.4 to -5.3%), p < 0.001), while the incremental AUC (iAUC) was reduced only following the 10 min (-38.0% (-63.7 to -12.3%), p = 0.005)","[{'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Moore', 'Affiliation': 'School of Exercise and Nutritional Sciences, San Diego State University, San Diego, CA, 92182-7251, USA. Electronic address: Jmoore714@gmail.com.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Salmons', 'Affiliation': 'School of Exercise and Nutritional Sciences, San Diego State University, San Diego, CA, 92182-7251, USA.'}, {'ForeName': 'Cameron', 'Initials': 'C', 'LastName': 'Vinoskey', 'Affiliation': 'School of Exercise and Nutritional Sciences, San Diego State University, San Diego, CA, 92182-7251, USA.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Kressler', 'Affiliation': 'School of Exercise and Nutritional Sciences, San Diego State University, San Diego, CA, 92182-7251, USA.'}]","Nutrition, metabolism, and cardiovascular diseases : NMCD",['10.1016/j.numecd.2020.06.020']
2502,32811740,Self-management education may improve blood pressure in people with type 2 diabetes. A randomized controlled clinical trial.,"BACKGROUND AND AIMS


Diabetes is a suitable model to evaluate intervention programmes aimed at chronic diseases, because of its well-defined and measurable process and outcome indicators. In this study, we aimed at investigating the effects of group based self-management education on clinical and psychological variables in type 2 diabetes.
METHODS AND RESULTS


Four-year randomized controlled clinical trial (ISRCTN14558376) comparing Group Care and traditional one-to-one care. Clinical and psychological variables were monitored at baseline, 2 and 4 years. Although differences between groups appear to be non-significant at univariate analysis, body weight, BMI and HbA1c, systolic and diastolic blood pressure improved in the patients followed by Group Care but not among Controls. Prescription of lipid-lowering and anti-hypertensive agents did not change among the patients on Group Care, whereas anti-hypertensives were stepped up among Controls without improving their blood pressure. Multivariable analysis suggests that blood pressure improvement among patients on Group Care was independent of BMI, duration of diabetes and antihypertensive medication, suggesting a direct effect of education, presumably by increasing adherence. The ""Powerful Others"" dimension of the Locus of Control worsened and fear of complications decreased among Controls.
CONCLUSIONS


The results confirm that a multidisciplinary structured group educational approach improves blood pressure, presumably through better adherence to healthy lifestyle and medication, in people with type 2 diabetes.
CLINICAL TRIAL REGISTRATION NUMBER


ISRCTN14558376.",2020,"Although differences between groups appear to be non-significant at univariate analysis, body weight, BMI and HbA1c, systolic and diastolic blood pressure improved in the patients followed by Group Care but not among Controls.","['type 2 diabetes', 'people with type 2 diabetes']","['lipid-lowering and anti-hypertensive agents', 'Self-management education', 'group based self-management education', 'Group Care and traditional one-to-one care']","['fear of complications', 'blood pressure', 'blood pressure improvement', 'body weight, BMI and HbA1c, systolic and diastolic blood pressure']","[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0581567', 'cui_str': 'One to one care'}]","[{'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}]",,0.059892,"Although differences between groups appear to be non-significant at univariate analysis, body weight, BMI and HbA1c, systolic and diastolic blood pressure improved in the patients followed by Group Care but not among Controls.","[{'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Trento', 'Affiliation': 'Laboratory of Clinical Pedagogy, Department of Medical Sciences, University of Turin, Italy. Electronic address: marina.trento@unito.it.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Fornengo', 'Affiliation': 'Laboratory of Clinical Pedagogy, Department of Medical Sciences, University of Turin, Italy.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Amione', 'Affiliation': 'Laboratory of Clinical Pedagogy, Department of Medical Sciences, University of Turin, Italy.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Salassa', 'Affiliation': 'Laboratory of Clinical Pedagogy, Department of Medical Sciences, University of Turin, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Barutta', 'Affiliation': 'Laboratory of Clinical Pedagogy, Department of Medical Sciences, University of Turin, Italy.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Gruden', 'Affiliation': 'Laboratory of Clinical Pedagogy, Department of Medical Sciences, University of Turin, Italy.'}, {'ForeName': 'Aurora', 'Initials': 'A', 'LastName': 'Mazzeo', 'Affiliation': 'Laboratory of Clinical Pedagogy, Department of Medical Sciences, University of Turin, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Merlo', 'Affiliation': 'Laboratory of Clinical Pedagogy, Department of Medical Sciences, University of Turin, Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Chiesa', 'Affiliation': 'Links Foundation, Polytechnic University of Turin, Italy.'}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Cavallo', 'Affiliation': 'Department of Public Health and Paediatric Sciences, University of Turin, Italy.'}, {'ForeName': 'Lorena', 'Initials': 'L', 'LastName': 'Charrier', 'Affiliation': 'Department of Public Health and Paediatric Sciences, University of Turin, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Porta', 'Affiliation': 'Laboratory of Clinical Pedagogy, Department of Medical Sciences, University of Turin, Italy.'}]","Nutrition, metabolism, and cardiovascular diseases : NMCD",['10.1016/j.numecd.2020.06.023']
2503,32816561,Stent evaluation by coronary computed tomography angiography: a comparison between Iopamidol-370 and Ioversol-320 hypo-osmolar iodine concentration contrasts.,"OBJECTIVE


Qualitative and quantitative image analysis between Iopamidol-370 and Ioversol-320 in stents´ evaluation by coronary computed tomography angiography (CTA).
METHODS


Sixty-five patients with low-risk stable angina undergoing stent follow-up with coronary CTA were assigned to Iopamidol I-370 ( n  = 33) or Ioversol I-320 ( n  = 32) in this prospective, double-blind, non-inferiority, randomized trial. Stent lumen image quality was graded by 5-point Likert Scale. Lumen mean attenuation was measured at native coronary segments: pre-stent, post-stent, distal segments and at coronary plaques. Lumen attenuation increase (LAI) ratio was calculated for all stents. Heart rate (HR) variation, premature heart beats (PHB), heat sensation (HS), blooming and beam hardening were also assessed.
RESULTS


Image quality was similar between groups, with no significant difference (Likert score 4.48 ± 0.75  vs  4.54 ± 0.65,  p  = 0.5). There were similarities in LAI ratio between I-370 and I-320 (0.39 ± 0.42  vs  0.48 ± 0.44 HU,  p  = 0.08). Regarding lumen mean attenuation at native coronary segments, a significant difference was observed, with I-320 presenting lower values, including contrast mean attenuation in distal segments. After statistical multivariate analysis, three variables correlated with stent image quality: 1) stent diameter, 2) HR variation and 3) stent lumen LAI ratio.
CONCLUSIONS


There was no significant difference between Iopamidol-370 mgI ml -1  and Ioversol-320 mgI ml -1  contrasts regarding overall stent lumen image quality, which was mainly influenced by stent diameter, HR and LAI ratio. Advances in knowledge: Coronary CTA allows adequate stents' visualization and image quality is influenced by stent diameter, HR variation and LAI ratio.Stents' image quality showed no difference between different concentration contrasts (I-370 vs. I-320); however, higher concentration contrasts may provide an improved overall visualization, especially regarding coronary distal segments.",2020,"There was no significant difference between Iopamidol-370 mgI ml -1  and Ioversol-320 mgI ml -1  contrasts regarding overall stent lumen image quality, which was mainly influenced by stent diameter, HR and LAI ratio.","['knowledge', 'Sixty-five patients with low-risk stable angina undergoing stent follow-up with coronary CTA were assigned to']","['coronary computed tomography angiography', 'coronary computed tomography angiography (CTA', 'Iopamidol I-370 ( n  = 33) or Ioversol I-320']","['Lumen mean attenuation', 'Stent lumen image quality', 'stent image quality: 1) stent diameter, 2) HR variation and 3) stent lumen LAI ratio', 'Image quality', 'Lumen attenuation increase (LAI) ratio', 'Heart rate (HR) variation, premature heart beats (PHB), heat sensation (HS), blooming and beam hardening', 'LAI ratio']","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0450385', 'cui_str': '65'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0340288', 'cui_str': 'Stable angina'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0022026', 'cui_str': 'Iopamidol'}, {'cui': 'C4517743', 'cui_str': '370'}, {'cui': 'C0063828', 'cui_str': 'ioversol'}, {'cui': 'C4517711', 'cui_str': '320'}]","[{'cui': 'C0524461', 'cui_str': 'Structure of lumen of body system'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0443021', 'cui_str': 'Lai'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0425583', 'cui_str': 'Heart beat'}, {'cui': 'C0234193', 'cui_str': 'Ability to sense heat'}]",65.0,0.112651,"There was no significant difference between Iopamidol-370 mgI ml -1  and Ioversol-320 mgI ml -1  contrasts regarding overall stent lumen image quality, which was mainly influenced by stent diameter, HR and LAI ratio.","[{'ForeName': 'Annelisa Moura', 'Initials': 'AM', 'LastName': 'Garcia', 'Affiliation': 'Sirio-Libanes Hospital, Sao Paulo, SP, Brazil.'}, {'ForeName': 'Antonildes N', 'Initials': 'AN', 'LastName': 'Assunção-Jr', 'Affiliation': 'Sirio-Libanes Hospital, Sao Paulo, SP, Brazil.'}, {'ForeName': 'Roberto Nery', 'Initials': 'RN', 'LastName': 'Dantas-Jr', 'Affiliation': 'Sirio-Libanes Hospital, Sao Paulo, SP, Brazil.'}, {'ForeName': 'Jose Rodrigues', 'Initials': 'JR', 'LastName': 'Parga', 'Affiliation': 'Sirio-Libanes Hospital, Sao Paulo, SP, Brazil.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Ganem', 'Affiliation': 'Sirio-Libanes Hospital, Sao Paulo, SP, Brazil.'}]",The British journal of radiology,['10.1259/bjr.20200078']
2504,32822827,A community-based asthma program: Study design and methods of RVA Breathes.,"Disparities in pediatric asthma morbidity and healthcare utilization exist on the basis of race, ethnicity, environment, and income; interventions are needed to address these inequities. The following protocol describes an evidence-based intervention, RVA Breathes, designed to coordinate pediatric asthma care across family, home, community, and medical sectors. Community stakeholder feedback was utilized to refine the intervention specifically for the Richmond, Virginia community. The aims of this study are to assess the effect of RVA Breathes on asthma-related healthcare utilization, as well as secondary outcomes of asthma control, asthma symptoms, and quality of life. We will enroll 300 elementary school children from the Richmond City Public School system. Participants will be between the ages of 5-11, have a diagnosis of asthma, and have had an asthma exacerbation (as indicated by an asthma-related ED visit, hospitalization, unscheduled PCP visit, or use of systemic steroids) in the last two years. Participants will be randomized to one of three groups: asthma education + home environment remediation + school intervention, asthma education + home environment remediation, or a comparator condition. Data will be collected across one baseline research visit, four intervention sessions, and four follow-up research visits over the course of 18 months. A General Linear Mixed Model (GLMM) will be used to test primary aims. We expect the findings will provide support for coordination of asthma care across sectors. Further, we hope RVA Breathes will serve as a model of community-based pediatric asthma care.",2020,"The following protocol describes an evidence-based intervention, RVA Breathes, designed to coordinate pediatric asthma care across family, home, community, and medical sectors.","['Participants will be between the ages of 5-11, have a diagnosis of asthma, and have had an asthma exacerbation (as indicated by an asthma-related ED visit, hospitalization, unscheduled PCP visit, or use of systemic steroids) in the last two years', '300 elementary school children from the Richmond City Public School system']","['asthma education + home environment remediation + school intervention, asthma education + home environment remediation, or a comparator condition', 'RVA']","['asthma control, asthma symptoms, and quality of life']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0349790', 'cui_str': 'Exacerbation of asthma'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C3854240', 'cui_str': 'Unscheduled'}, {'cui': 'C0030855', 'cui_str': 'Pentachlorophenol'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0260267', 'cui_str': 'School child'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0557800', 'cui_str': 'Public school'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C1679754', 'cui_str': 'Asthma education'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",300.0,0.0360733,"The following protocol describes an evidence-based intervention, RVA Breathes, designed to coordinate pediatric asthma care across family, home, community, and medical sectors.","[{'ForeName': 'Robin S', 'Initials': 'RS', 'LastName': 'Everhart', 'Affiliation': 'Virginia Commonwealth University, Richmond, VA, United States of America. Electronic address: reverhart@vcu.edu.'}, {'ForeName': 'Suzanne E', 'Initials': 'SE', 'LastName': 'Mazzeo', 'Affiliation': 'Virginia Commonwealth University, Richmond, VA, United States of America.'}, {'ForeName': 'Rosalie', 'Initials': 'R', 'LastName': 'Corona', 'Affiliation': 'Virginia Commonwealth University, Richmond, VA, United States of America.'}, {'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'Holder', 'Affiliation': 'Virginia Commonwealth University, Richmond, VA, United States of America.'}, {'ForeName': 'Leroy R', 'Initials': 'LR', 'LastName': 'Thacker', 'Affiliation': 'Virginia Commonwealth University, Richmond, VA, United States of America.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Schechter', 'Affiliation': ""Children's Hospital of Richmond at VCU, Richmond, VA, United States of America.""}]",Contemporary clinical trials,['10.1016/j.cct.2020.106121']
2505,32822968,"Improvement in overall survival with Apalutamide, Darolutamide and Enzalutamide in patients with non-metastatic castration-resistant prostate cancer.","Since 2018, apalutamide, darolutamide, and enzalutamide have been approved for the treatment of men with non-metastatic castration-resistant prostate cancer (M0CRPC). These approvals were based on the results of three separate randomized, placebo-controlled, phase III trials: SPARTAN (apalutamide), ARAMIS (darolutamide) and PROSPER (enzalutamide). These trials included men with M0CRPC and a short PSA doubling time (≤10 months). Results demonstrated a longer metastasis-free survival with these agents when used in conjunction with androgen deprivation therapy (ADT), compared to ADT alone. Updated results of these trials presented in the 2020 annual meeting of American Society of Oncology (ASCO) showed significantly improved overall survival with these agents. Based on these results, apalutamide, darolutamide, and enzalutamide can now be considered the standard of care treatment options for the treatment of men with M0CRPC.",2020,"Results demonstrated a longer metastasis-free survival with these agents when used in conjunction with androgen deprivation therapy (ADT), compared to ADT alone.","['men with M0CRPC and a short PSA doubling time (≤10 months', 'men with non-metastatic castration-resistant prostate cancer (M0CRPC', 'men with M0CRPC', 'patients with non-metastatic castration-resistant prostate cancer']","['Apalutamide, Darolutamide and Enzalutamide', 'ARAMIS (darolutamide) and PROSPER (enzalutamide', 'androgen deprivation therapy (ADT', 'placebo']","['overall survival', 'longer metastasis-free survival']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C4329353', 'cui_str': 'apalutamide'}, {'cui': 'C4547776', 'cui_str': 'darolutamide'}, {'cui': 'C3496793', 'cui_str': 'enzalutamide'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]",,0.0449496,"Results demonstrated a longer metastasis-free survival with these agents when used in conjunction with androgen deprivation therapy (ADT), compared to ADT alone.","[{'ForeName': 'Umang', 'Initials': 'U', 'LastName': 'Swami', 'Affiliation': 'Division of Oncology, Department of Internal Medicine, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT, USA. Electronic address: umang.swami@hci.utah.edu.'}, {'ForeName': 'Neeraj', 'Initials': 'N', 'LastName': 'Agarwal', 'Affiliation': 'Division of Oncology, Department of Internal Medicine, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT, USA.'}]",Cancer treatment and research communications,['10.1016/j.ctarc.2020.100205']
2506,32824394,"Effects of Virtual Reality versus Exercise on Pain, Functional, Somatosensory and Psychosocial Outcomes in Patients with Non-specific Chronic Neck Pain: A Randomized Clinical Trial.","Background : Virtual reality (VR) applied to patients with neck pain is a promising intervention to produce positive effects when used alone or combined with exercise. Therefore, the objective of this manuscript is to compare the effects of VR versus exercise treatment on pain intensity, conditioned pain modulation (CPM), temporal summation (TS) and functional and somatosensory outcomes in patients with non-specific chronic neck pain (NS-CNP).  Methods : A single-blinded, randomized clinical trial was carried out. A total sample of 44 patients with NS-CNP was randomized into a VR treatment group or neck exercises group. The intervention consisted of two treatment sessions per week, for four weeks and eight sessions. Four measurement moments (at baseline, immediately, 1 month, and 3 months after intervention) were considered. Pain intensity, CPM, TS, functional and somatosensory outcomes were measured.  Results : Statistically significant differences were revealed for time factor (F = 16.40,  p  < 0.01, η p 2  = 0.28) and group*time interaction for kinesiophobia (F = 3.89,  p  = 0.01, η p 2  = 0.08) showing post-hoc differences in favor of the VR group at 3 months ( p  < 0.05, d = 0.65). Significant effects were shown for time factor ( p  < 0.05) but not for the group*time interaction ( p  > 0.05) for pain intensity, rotation range of motion (ROM), Neck Disability Index, pain catastrophizing, fear-avoidance beliefs, left side pressure pain threshold (PPT) and anxiety. Statistically significant differences were not found for time factor ( p  > 0.05) and neither in group*time interaction ( p  > 0.05) for CPM, TS, right side PPT, flexo-extension and lateral-flexion ROM.  Conclusions : Kinesiophobia was the only outcome that showed differences between VR and exercise at 3 months. Nevertheless, pain intensity, CPM, TS, ROM, neck disability, pain catastrophizing, fear-avoidance beliefs, PPT and anxiety did not show differences between both interventions.",2020,"Statistically significant differences were not found for time factor ( p  > 0.05) and neither in group*time interaction ( p  > 0.05) for CPM, TS, right side PPT, flexo-extension and lateral-flexion ROM.  ","['Patients with Non-specific Chronic Neck Pain', 'patients with non-specific chronic neck pain (NS-CNP', '44 patients with NS-CNP', 'patients with neck pain']","[' ', 'Kinesiophobia', 'Virtual Reality versus Exercise', 'Virtual reality (VR', 'VR treatment group or neck exercises group', 'VR versus exercise']","['CPM, TS, right side PPT, flexo-extension and lateral-flexion ROM', 'pain intensity, CPM, TS, ROM, neck disability, pain catastrophizing, fear-avoidance beliefs, PPT and anxiety', 'pain intensity, rotation range of motion (ROM), Neck Disability Index, pain catastrophizing, fear-avoidance beliefs, left side pressure pain threshold (PPT) and anxiety', 'time factor', 'group*time interaction for kinesiophobia', 'pain intensity, conditioned pain modulation (CPM), temporal summation (TS) and functional and somatosensory outcomes', 'Pain intensity, CPM, TS, functional and somatosensory outcomes', 'Pain, Functional, Somatosensory and Psychosocial Outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0746815', 'cui_str': 'Chronic neck pain'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}]","[{'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0454347', 'cui_str': 'Neck exercises'}]","[{'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0234110', 'cui_str': 'Temporal summation'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0032334', 'cui_str': 'podofilox'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0439791', 'cui_str': 'Lateral flexion'}, {'cui': 'C0948106', 'cui_str': 'Amniorrhexis'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0040225', 'cui_str': 'Time Factors'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",44.0,0.113865,"Statistically significant differences were not found for time factor ( p  > 0.05) and neither in group*time interaction ( p  > 0.05) for CPM, TS, right side PPT, flexo-extension and lateral-flexion ROM.  ","[{'ForeName': 'David Morales', 'Initials': 'DM', 'LastName': 'Tejera', 'Affiliation': 'Escuela Internacional de Doctorado, Department of Physical Therapy, Occupational Therapy, Rehabilitation and Physical Medicine, Universidad Rey Juan Carlos, 28032 Alcorcón, Spain.'}, {'ForeName': 'Hector', 'Initials': 'H', 'LastName': 'Beltran-Alacreu', 'Affiliation': 'Departamento de Fisioterapia, Centro Superior de Estudios Universitarios La Salle, Universidad Autónoma de Madrid, 28043 Madrid, Spain.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Cano-de-la-Cuerda', 'Affiliation': 'Department of Physical Therapy, Occupational Therapy, Rehabilitation and Physical Medicine. Rey Juan Carlos University, 28922 Madrid, Spain.'}, {'ForeName': 'Jose Vicente', 'Initials': 'JV', 'LastName': 'Leon Hernández', 'Affiliation': 'Departamento de Fisioterapia, Centro Superior de Estudios Universitarios La Salle, Universidad Autónoma de Madrid, 28043 Madrid, Spain.'}, {'ForeName': 'Aitor', 'Initials': 'A', 'LastName': 'Martín-Pintado-Zugasti', 'Affiliation': 'Departamento de Fisioterapia, Facultad de Medicina, Universidad San Pablo-CEU, CEU Universities, Madrid 28008, Spain.'}, {'ForeName': 'César', 'Initials': 'C', 'LastName': 'Calvo-Lobo', 'Affiliation': 'Facultad de Enfermería, Fisioterapia y Podología, Universidad Complutense de Madrid, 28040 Madrid, Spain.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Gil-Martínez', 'Affiliation': 'CranioSpain Research Group, Centro Superior de Estudios Universitarios La Salle, Universidad Autónoma de Madrid, 28043 Madrid, Spain.'}, {'ForeName': 'Josué', 'Initials': 'J', 'LastName': 'Fernández-Carnero', 'Affiliation': 'CranioSpain Research Group, Centro Superior de Estudios Universitarios La Salle, Universidad Autónoma de Madrid, 28043 Madrid, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17165950']
2507,32827953,The strap intermuscular approach can significantly increase the exposure rate of the external branch of the superior laryngeal nerve during thyroid surgery.,"BACKGROUND


Avoiding injury to the external branch of the superior laryngeal nerve (EBSLN) is a major challenge during thyroid surgery. EBSLN injury can have an impact on the quality of life of patients. The aim of this study was to introduce the strap intermuscular approach, to dissect the EBSLN with two different approaches in thyroid surgery, to compare the differences between these two approaches, and to describe a way for surgeons to treat the upper thyroid gland to find the EBSLN.
METHODS


A prospective study of hemithyroidectomy was performed. In total, 104 patients were included and randomly divided into two groups: one group used the traditional approach to expose and protect the EBSLN, and the other group used the strap intermuscular approach. We described the surgical procedure for the strap intermuscular approach and compared the differences in the rates of EBSLN exposure, injury, and classification to illustrate the advantages of the intermuscular approach in thyroid surgery.
RESULTS


The exposure rate of the EBSLN was higher with the strap intermuscular approach than with the traditional approach (96.15% vs. 76.92%, p = 0.01), with an odds ratio (OR) and 95% confidence interval (CI) of 0.133 (0.028-0.630). The exposure rate of EBSLNs classified as type 1 was higher in the strap intermuscular approach than in the traditional approach (30.77% vs. 13.46%, p = 0.033), with an OR and 95% CI of 0.350 (0.130-0.942).
CONCLUSIONS


The exposure rate of the EBSLN was significantly higher with the strap intermuscular approach method than with the traditional approach during thyroid surgery. This approach allows for better identification of the EBSLN during thyroidectomy.",2020,"The exposure rate of the EBSLN was higher with the strap intermuscular approach than with the traditional approach (96.15% vs. 76.92%, p = 0.01), with an odds ratio (OR) and 95% confidence interval (CI) of 0.133 (0.028-0.630).",['104 patients'],"['traditional approach to expose and protect the EBSLN, and the other group used the strap intermuscular approach', 'hemithyroidectomy']",['exposure rate of the EBSLN'],"[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C1253959', 'cui_str': 'Branch of'}, {'cui': 'C0205814', 'cui_str': 'Structure of superior laryngeal nerve'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0183631', 'cui_str': 'Strap'}, {'cui': 'C0405532', 'cui_str': 'Lobectomy of thyroid gland'}]","[{'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C1253959', 'cui_str': 'Branch of'}, {'cui': 'C0205814', 'cui_str': 'Structure of superior laryngeal nerve'}]",104.0,0.0387604,"The exposure rate of the EBSLN was higher with the strap intermuscular approach than with the traditional approach (96.15% vs. 76.92%, p = 0.01), with an odds ratio (OR) and 95% confidence interval (CI) of 0.133 (0.028-0.630).","[{'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Zhou', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Yifei', 'Initials': 'Y', 'LastName': 'Zhai', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Hu', 'Initials': 'H', 'LastName': 'Hei', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Songtao', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Chuang', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Wenbo', 'Initials': 'W', 'LastName': 'Gong', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Runfang', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Zheng', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Jianwu', 'Initials': 'J', 'LastName': 'Qin', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China. Electronic address: qinjianwu_62@163.com.'}]",Surgical oncology,['10.1016/j.suronc.2020.08.004']
2508,32830463,Kinetic-Pharmacodynamic Model of Platelet Time Course in Patients With Moderate-to-Severe Atopic Dermatitis Treated With Oral Janus Kinase 1 Inhibitor Abrocitinib.,"The oral Janus kinase 1 (JAK1) inhibitor abrocitinib reduced signs and symptoms of atopic dermatitis (AD) in a placebo-controlled, randomized, double-blind, phase IIb trial (dose range 10-200 mg). A kinetic-pharmacodynamic (K-PD) model consisting of proliferation, maturation, and blood circulation compartments was developed to characterize platelet count changes during the study. The K-PD model consisted of a drug elimination constant, four system parameters describing platelet dynamics, variance terms, correlation, and residual errors. Overall, these patients exhibited mean transit time from progenitor cells to platelets of 8.2 days (longer than the reported megakaryocyte life span), likely arising from JAK1-induced perturbations of platelet progenitor homeostasis. The final model described dose-related platelet count declines until nadir at treatment week 4 and return to baseline levels thereafter. The model was deemed suitable to support the design of subsequent abrocitinib AD trials and indicated limited clinically relevant platelet reductions in the range of doses studied.",2020,The model was deemed suitable to support the design of subsequent abrocitinib AD trials and indicated limited clinically relevant platelet reductions in the range of doses studied.,['Patients With Moderate-to-Severe Atopic Dermatitis'],[],['mean transit time'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1301827', 'cui_str': 'In transit'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.114435,The model was deemed suitable to support the design of subsequent abrocitinib AD trials and indicated limited clinically relevant platelet reductions in the range of doses studied.,"[{'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Soto', 'Affiliation': 'Pfizer UK Limited, Sandwich, UK.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Banfield', 'Affiliation': 'Pfizer Inc., Cambridge, Massachusetts, USA.'}, {'ForeName': 'Pankaj', 'Initials': 'P', 'LastName': 'Gupta', 'Affiliation': 'Pfizer Inc., Cambridge, Massachusetts, USA.'}, {'ForeName': 'Mark C', 'Initials': 'MC', 'LastName': 'Peterson', 'Affiliation': 'Pfizer Inc., Cambridge, Massachusetts, USA.'}]",CPT: pharmacometrics & systems pharmacology,['10.1002/psp4.12548']
2509,32831169,A stepped-wedge randomised trial on the impact of early ART initiation on HIV-patients' economic outcomes in Eswatini.,"Background


Since 2015, the World Health Organisation (WHO) recommends immediate initiation of antiretroviral therapy (ART) for all HIV-positive patients. Epidemiological evidence points to important health benefits of immediate ART initiation; however, the policy’s impact on the economic aspects of patients' lives remains unknown.
Methods


We conducted a stepped-wedge cluster-randomised controlled trial in Eswatini to determine the causal impact of immediate ART initiation on patients’ individual- and household-level economic outcomes. Fourteen healthcare facilities were non-randomly matched into pairs and then randomly allocated to transition from the standard of care (ART eligibility at CD4 counts of <350 cells/mm3 until September 2016 and <500 cells/mm3 thereafter) to the ‘Early Initiation of ART for All’ (EAAA) intervention at one of seven timepoints. Patients, healthcare personnel, and outcome assessors remained unblinded. Data were collected via standardised paper-based surveys with HIV-positive adults who were neither pregnant nor breastfeeding. Outcomes were patients’ time use, employment status, household expenditures, and household living standards.
Results


A total sample of 3019 participants were interviewed over the duration of the study. The mean number of participants approached at each facility per time step varied from 4 to 112 participants. Using mixed-effects negative binomial regressions accounting for time trends and clustering at the level of the healthcare facility, we found no significant difference between study arms for any economic outcome. Specifically, the EAAA intervention had no significant effect on non-resting time use (RR = 1.00 [CI: 0.96, 1.05, p=0.93]) or income-generating time use (RR = 0.94, [CI: 0.73,1.20, p=0.61]). Employment and household expenditures decreased slightly but not significantly in the EAAA group, with risk ratios of 0.93 [CI: 0.82, 1.04, p=0.21] and 0.92 [CI: 0.79, 1.06, p=0.26], respectively. We also found no significant treatment effect on households’ asset ownership and living standards (RR = 0.96, [CI 0.92, 1.00, p=0.253]). Lastly, there was no evidence of heterogeneity in effect estimates by patients’ sex, age, education, timing of HIV diagnosis and ART initiation.
Conclusions


Our findings do not provide evidence that should discourage further investments into scaling up immediate ART for all HIV patients.
Funding


Funded by the Dutch Postcode Lottery in the Netherlands, Alexander von Humboldt-Stiftung (Humboldt-Stiftung), the Embassy of the Kingdom of the Netherlands in South Africa/Mozambique, British Columbia Centre of Excellence in Canada, Doctors Without Borders (MSF USA), National Center for Advancing Translational Sciences of the National Institutes of Health and Joachim Herz Foundation.
Clinical trial number


NCT02909218 and NCT03789448.",2020,"Employment and household expenditures decreased slightly but not significantly in the EAAA group, with risk ratios of 0.93","['Fourteen healthcare facilities', ""HIV patients' economic welfare in Eswatini"", ""patients' economic welfare"", 'A total sample of 3,019 participants were interviewed over the duration of the study']","['immediate ART initiation', 'antiretroviral therapy (ART']","['Employment and household expenditures', 'time use, employment status, household expenditures and household wealth', 'non-resting time use']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0037440', 'cui_str': 'Social services'}, {'cui': 'C0038983', 'cui_str': 'Swaziland'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]","[{'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0015316', 'cui_str': 'Expenditures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0242271', 'cui_str': 'Employment status'}, {'cui': 'C0035253', 'cui_str': 'Rest'}]",3019.0,0.412335,"Employment and household expenditures decreased slightly but not significantly in the EAAA group, with risk ratios of 0.93","[{'ForeName': 'Janina Isabel', 'Initials': 'JI', 'LastName': 'Steinert', 'Affiliation': 'Technical University of Munich, Munich, Germany.'}, {'ForeName': 'Shaukat', 'Initials': 'S', 'LastName': 'Khan', 'Affiliation': 'Clinton Health Acccess Initiative, Boston, United States.'}, {'ForeName': 'Khudzie', 'Initials': 'K', 'LastName': 'Mlambo', 'Affiliation': 'Clinton Health Acccess Initiative, Boston, United States.'}, {'ForeName': 'Fiona J', 'Initials': 'FJ', 'LastName': 'Walsh', 'Affiliation': 'Clinton Health Acccess Initiative, Boston, United States.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Mafara', 'Affiliation': 'Clinton Health Acccess Initiative, Boston, United States.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Lejeune', 'Affiliation': 'Clinton Health Acccess Initiative, Boston, United States.'}, {'ForeName': 'Cebele', 'Initials': 'C', 'LastName': 'Wong', 'Affiliation': 'Clinton Health Acccess Initiative, Boston, United States.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Hettema', 'Affiliation': 'Clinton Health Acccess Initiative, Boston, United States.'}, {'ForeName': 'Osondu', 'Initials': 'O', 'LastName': 'Ogbuoji', 'Affiliation': 'Center for Policy Impact in Global Health, Duke Global Health Institute, Duke University, Durham, United States.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Vollmer', 'Affiliation': 'University of Goettingen, Goettingen, Germany.'}, {'ForeName': 'Jan-Walter', 'Initials': 'JW', 'LastName': 'De Neve', 'Affiliation': 'Heidelberg Institute of Global Health, Heidelberg University, Heidelberg, Germany.'}, {'ForeName': 'Sikhathele', 'Initials': 'S', 'LastName': 'Mazibuko', 'Affiliation': 'Ministry of Health of the Kingdom of Eswatini, Mbabane, Eswatini.'}, {'ForeName': 'Velephi', 'Initials': 'V', 'LastName': 'Okello', 'Affiliation': 'Ministry of Health of the Kingdom of Eswatini, Mbabane, Eswatini.'}, {'ForeName': 'Till', 'Initials': 'T', 'LastName': 'Bärnighausen', 'Affiliation': 'Heidelberg Institute of Global Health, Heidelberg University, Heidelberg, Germany.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Geldsetzer', 'Affiliation': 'Heidelberg Institute of Global Health, Heidelberg University, Heidelberg, Germany.'}]",eLife,['10.7554/eLife.58487']
2510,32840412,Oral antibiotics used in the treatment of chronic rhinosinusitis have limited penetration into the sinonasal mucosa: a randomized trial.,"Despite the widespread prescription of antibiotics for patients with chronic rhinosinusitis (CRS), the extent to which drug distribution to the sinonasal mucosa occurs remains largely undefined. Twenty subjects undergoing functional endoscopic sinus surgery (FESS) for CRS were randomized to one of two groups: 1) doxycycline (100 mg daily for seven days) 2) roxithromycin (300 mg daily for seven days). Drug levels were measured using liquid chromatography-tandem mass spectrometry in sinonasal mucus, sinonasal tissues and serum at steady state. Doxycycline concentrations measured in the mucus were significantly lower compared to that in the serum (mean mucus/serum ratio = 0.16,  p  < 0.001) and the tissue (mean mucus/tissue ratio = 0.18,  p  < 0.0001). Roxithromycin concentrations in the mucus were also significantly lower compared to that in the serum (mean mucus/serum ratio = 0.37,  p  = 0.002) and the tissue (mean mucus/tissue ratio = 0.60,  p  < 0.001). Although the efficacy of doxycycline and roxithromycin in sinonasal mucus in vivo cannot be predicted solely from reported minimum inhibitory concentrations, given the added complexity of bacterial biofilm antimicrobial tolerance, these results suggest that low mucosal penetration of antibiotics may be one of the factors contributing to the limited efficacy of these agents in the treatment of CRS.",2020,"Doxycycline concentrations measured in the mucus were significantly lower compared to that in the serum (mean mucus/serum ratio =0.16, p < 0.001) and the tissue (mean mucus/tissue ratio =0.18, p < 0.0001).","['Twenty subjects undergoing functional endoscopic sinus surgery (FESS) for CRS', 'patients with chronic rhinosinusitis (CRS']","['roxithromycin', 'Oral antibiotics', 'doxycycline']","['Drug levels', 'Doxycycline concentrations', 'Roxithromycin concentrations']","[{'cui': 'C0442968', 'cui_str': 'Functional endoscopic sinus surgery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0010278', 'cui_str': 'Craniosynostosis syndrome'}]","[{'cui': 'C0035891', 'cui_str': 'Roxithromycin'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0013090', 'cui_str': 'Doxycycline'}]","[{'cui': 'C1261153', 'cui_str': 'Drug level'}, {'cui': 'C0013090', 'cui_str': 'Doxycycline'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0035891', 'cui_str': 'Roxithromycin'}]",,0.0192049,"Doxycycline concentrations measured in the mucus were significantly lower compared to that in the serum (mean mucus/serum ratio =0.16, p < 0.001) and the tissue (mean mucus/tissue ratio =0.18, p < 0.0001).","[{'ForeName': 'Joey', 'Initials': 'J', 'LastName': 'Siu', 'Affiliation': 'Department of Surgery, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Klingler', 'Affiliation': 'Research and Development, Zenith Technology Corporation Limited, Dunedin, New Zealand.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Research and Development, Zenith Technology Corporation Limited, Dunedin, New Zealand.'}, {'ForeName': 'Cheung-Tak', 'Initials': 'CT', 'LastName': 'Hung', 'Affiliation': 'Research and Development, Zenith Technology Corporation Limited, Dunedin, New Zealand.'}, {'ForeName': 'Soo Hee', 'Initials': 'SH', 'LastName': 'Jeong', 'Affiliation': 'Department of Pharmacology and Clinical Pharmacology, The University of Auckland, Auckland, New\xa0Zealand.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Smith', 'Affiliation': 'Labtests NZ, Auckland, New Zealand.'}, {'ForeName': 'Malcolm Drummond', 'Initials': 'MD', 'LastName': 'Tingle', 'Affiliation': 'Department of Pharmacology and Clinical Pharmacology, The University of Auckland, Auckland, New\xa0Zealand.'}, {'ForeName': 'Brett', 'Initials': 'B', 'LastName': 'Wagner Mackenzie', 'Affiliation': 'Department of Surgery, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Kristi', 'Initials': 'K', 'LastName': 'Biswas', 'Affiliation': 'Department of Surgery, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Richard George', 'Initials': 'RG', 'LastName': 'Douglas', 'Affiliation': 'Department of Surgery, The University of Auckland, Auckland, New Zealand.'}]",Xenobiotica; the fate of foreign compounds in biological systems,['10.1080/00498254.2020.1814973']
2511,32840418,"Patient-Centered Outcomes in ARIEL3, a Phase III, Randomized, Placebo-Controlled Trial of Rucaparib Maintenance Treatment in Patients With Recurrent Ovarian Carcinoma.","PURPOSE


To investigate quality-adjusted progression-free survival (QA-PFS) and quality-adjusted time without symptoms or toxicity (Q-TWiST) in a post hoc exploratory analysis of the phase III ARIEL3 study of rucaparib maintenance treatment versus placebo.
PATIENTS AND METHODS


Patients with platinum-sensitive, recurrent ovarian carcinoma were randomly assigned to rucaparib (600 mg twice per day) or placebo. QA-PFS was calculated as progression-free survival function × the 3-level version of the EQ-5D questionnaire (EQ-5D-3L) index score function. Q-TWiST analyses were performed defining TOX as the mean duration in which a patient experienced grade ≥ 3 treatment-emergent adverse events (TEAEs) or the mean duration in which a patient experienced grade ≥ 2 TEAEs of nausea, vomiting, fatigue, and asthenia. Q-TWiST was calculated as μTOX × TOX + TWiST, with μTOX calculated using EQ-5D-3L data.
RESULTS


The visit cutoff was Apr 15, 2017. Mean QA-PFS was significantly longer with rucaparib versus placebo in the intent-to-treat (ITT) population (375 randomly assigned to rucaparib  v  189 randomly assigned to placebo; difference, 6.28 months [95% CI, 4.85 to 7.47 months]);  BRCA -mutant cohort (130 rucaparib  v  66 placebo; 9.37 months [95% CI, 6.65 to 11.85 months]); homologous recombination deficient (HRD) cohort (236 rucaparib  v  118 placebo; 7.93 months [95% CI, 5.93 to 9.53 months]); and  BRCA  wild-type/loss of heterozygosity (LOH) low patient subgroup (107 rucaparib  v  54 placebo; 2.71 months [95% CI, 0.31 to 4.44 months]). With TOX defined using grade ≥ 3 TEAEs, the difference in mean Q-TWiST (rucaparib  v  placebo) was 6.88 months (95% CI, 5.71 to 8.23 months), 9.73 months (95% CI, 7.10 to 11.94 months), 8.11 months (95% CI, 6.36 to 9.49 months), and 3.35 months (95% CI, 1.66 to 5.40 months) in the ITT population,  BRCA -mutant cohort, HRD cohort, and  BRCA  wild-type/LOH low patient subgroup, respectively. Q-TWiST with TOX defined using select grade ≥ 2 TEAEs also consistently favored rucaparib.
CONCLUSION


The significant differences in QA-PFS and Q-TWiST confirm the benefit of rucaparib versus placebo in all predefined cohorts.",2020,"Mean QA-PFS was significantly longer with rucaparib versus placebo in the intent-to-treat (ITT) population (375 randomly assigned to rucaparib  v  189 randomly assigned to placebo; difference, 6.28 months [95% CI, 4.85 to 7.47 months]);  ","['Patients With Recurrent Ovarian Carcinoma', 'Patients with platinum-sensitive, recurrent ovarian carcinoma']","['Rucaparib Maintenance Treatment', 'rucaparib versus placebo', 'placebo', 'rucaparib', 'Placebo']","['quality-adjusted progression-free survival (QA-PFS) and quality-adjusted time without symptoms or toxicity (Q-TWiST', 'nausea, vomiting, fatigue, and asthenia', 'Mean QA-PFS', 'mean Q-TWiST', 'QA-PFS', 'EQ-5D questionnaire (EQ-5D-3L) index score function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278689', 'cui_str': 'Recurrent ovarian cancer'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]","[{'cui': 'C3661315', 'cui_str': 'rucaparib'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0004093', 'cui_str': 'Asthenia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",,0.300562,"Mean QA-PFS was significantly longer with rucaparib versus placebo in the intent-to-treat (ITT) population (375 randomly assigned to rucaparib  v  189 randomly assigned to placebo; difference, 6.28 months [95% CI, 4.85 to 7.47 months]);  ","[{'ForeName': 'Amit M', 'Initials': 'AM', 'LastName': 'Oza', 'Affiliation': 'Princess Margaret Cancer Centre, University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'Domenica', 'Initials': 'D', 'LastName': 'Lorusso', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Aghajanian', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Oaknin', 'Affiliation': ""Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona, Spain.""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Dean', 'Affiliation': 'St John of God Subiaco Hospital, Subiaco, WA, Australia.'}, {'ForeName': 'Nicoletta', 'Initials': 'N', 'LastName': 'Colombo', 'Affiliation': 'University of Milan-Bicocca and European Institute of Oncology, Milan, Italy.'}, {'ForeName': 'Johanne I', 'Initials': 'JI', 'LastName': 'Weberpals', 'Affiliation': 'Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Clamp', 'Affiliation': 'The Christie NHS Foundation Trust and University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Scambia', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Leary', 'Affiliation': ""Gustave Roussy Cancer Center, INSERM U981, and Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens, Villejuif, France.""}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Holloway', 'Affiliation': 'AdventHealth Cancer Institute, Orlando, FL.'}, {'ForeName': 'Margarita Amenedo', 'Initials': 'MA', 'LastName': 'Gancedo', 'Affiliation': 'Oncology Center of Galicia, Doctor Camilo Veiras, La Coruña, Spain.'}, {'ForeName': 'Peter C', 'Initials': 'PC', 'LastName': 'Fong', 'Affiliation': 'Auckland City Hospital, Auckland, New Zealand.'}, {'ForeName': 'Jeffrey C', 'Initials': 'JC', 'LastName': 'Goh', 'Affiliation': ""Royal Brisbane and Women's Hospital and University of Queensland, St Lucia, Australia.""}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': ""O'Malley"", 'Affiliation': 'The Ohio State University, James Cancer Center, Columbus, OH.'}, {'ForeName': 'Deborah K', 'Initials': 'DK', 'LastName': 'Armstrong', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Banerjee', 'Affiliation': 'The Royal Marsden NHS Foundation Trust and The Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'Jesus', 'Initials': 'J', 'LastName': 'García-Donas', 'Affiliation': 'HM Hospitales-Centro Integral Oncológico Hospital de Madrid Clara Campal, Madrid, Spain.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Swisher', 'Affiliation': 'University of Washington, Seattle, WA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cella', 'Affiliation': 'Feinberg School of Medicine, Northwestern University, Chicago, IL.'}, {'ForeName': 'Juliette', 'Initials': 'J', 'LastName': 'Meunier', 'Affiliation': 'Modus Outcomes, Lyon, France.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Goble', 'Affiliation': 'Clovis Oncology, Inc., Boulder, CO.'}, {'ForeName': 'Terri', 'Initials': 'T', 'LastName': 'Cameron', 'Affiliation': 'Clovis Oncology UK, Ltd., Cambridge, United Kingdom.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Maloney', 'Affiliation': 'Clovis Oncology, Inc., Boulder, CO.'}, {'ForeName': 'Ann-Christin', 'Initials': 'AC', 'LastName': 'Mörk', 'Affiliation': 'Clovis Oncology Denmark, ApS, Copenhagen, Denmark.'}, {'ForeName': 'Josh', 'Initials': 'J', 'LastName': 'Bedel', 'Affiliation': 'Clovis Oncology Switzerland, GmBH, Zurich, Switzerland.'}, {'ForeName': 'Jonathan A', 'Initials': 'JA', 'LastName': 'Ledermann', 'Affiliation': 'UCL Cancer Institute, University College London, and UCL Hospitals, London, United Kingdom.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Coleman', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.03107']
2512,32833935,Racial Differences in the Effectiveness of a Multifactorial Telehealth Intervention to Slow Diabetic Kidney Disease.,"BACKGROUND


African Americans are significantly more likely than non-African Americans to have diabetes, chronic kidney disease, and uncontrolled hypertension, increasing their risk for kidney function decline.
OBJECTIVE


The objective of this study was to compare how African Americans and non-African Americans with diabetes responded to a multifactorial telehealth intervention designed to slow kidney function decline.
RESEARCH DESIGN


Secondary analysis of a randomized trial. Primary care patients (N=281, 56% African American) were allocated to either: (1) a multifactorial, pharmacist-delivered phone-based telehealth intervention focused on behavioral and medication management of diabetic kidney disease; or (2) an education control.
MEASURES


The primary study outcome was change in estimated glomerular filtration rate (eGFR). Linear mixed models were used to explore the moderating effect of race on the relationship between study arm and eGFR decline over time; the mean annual rate of eGFR decline was estimated by race and study arm.
RESULTS


Findings demonstrated a differential intervention effect on kidney function over time by race (Pinteraction=0.005). Among African Americans, the intervention arm had significantly greater preservation of eGFR over time than the control arm (difference in the annual rate of eGFR decline=1.5 mL/min/1.73 m; 95% confidence interval: 0.04, 3.02). For non-African Americans, the intervention arm had a faster decline in eGFR over time than the control arm (difference in the annual rate of eGFR decline=-1.7 mL/min/1.73 m; 95% confidence interval: -3.3, -0.02).
CONCLUSION


A multifactorial, pharmacist-delivered telehealth intervention for diabetic kidney disease may be more effective for slowing eGFR decline among African Americans than non-African Americans.",2020,"For non-African Americans, the intervention arm had a faster decline in eGFR over time than the control arm (difference in the annual rate of eGFR decline=-1.7 mL/min/1.73 m; 95% confidence interval: -3.3, -0.02).
","['African Americans and non-African Americans with diabetes', 'African Americans than non-African Americans', 'Slow Diabetic Kidney Disease', 'Primary care patients (N=281, 56% African American', 'African Americans']","['multifactorial, pharmacist-delivered phone-based telehealth intervention focused on behavioral and medication management of diabetic kidney disease; or (2) an education control', 'Multifactorial Telehealth Intervention', 'multifactorial telehealth intervention']","['preservation of eGFR', 'kidney function', 'estimated glomerular filtration rate (eGFR']","[{'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0011881', 'cui_str': 'Kidney disorder due to diabetes mellitus'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0150270', 'cui_str': 'Management of drug regimen'}, {'cui': 'C0011881', 'cui_str': 'Kidney disorder due to diabetes mellitus'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0232804', 'cui_str': 'Renal function'}]",,0.068358,"For non-African Americans, the intervention arm had a faster decline in eGFR over time than the control arm (difference in the annual rate of eGFR decline=-1.7 mL/min/1.73 m; 95% confidence interval: -3.3, -0.02).
","[{'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Kobe', 'Affiliation': 'Duke University School of Medicine.'}, {'ForeName': 'Clarissa J', 'Initials': 'CJ', 'LastName': 'Diamantidis', 'Affiliation': 'Department of Population Health Sciences.'}, {'ForeName': 'Hayden B', 'Initials': 'HB', 'LastName': 'Bosworth', 'Affiliation': 'Department of Population Health Sciences.'}, {'ForeName': 'Clemontina A', 'Initials': 'CA', 'LastName': 'Davenport', 'Affiliation': 'Biostatistics and Bioinformatics.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Oakes', 'Affiliation': 'Department of Medicine, Division of General Internal Medicine.'}, {'ForeName': 'Anastasia-Stefania', 'Initials': 'AS', 'LastName': 'Alexopoulos', 'Affiliation': 'Durham Veterans Affairs Center of Innovation to Accelerate Discovery and Practice Change (ADAPT).'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Pendergast', 'Affiliation': 'Biostatistics and Bioinformatics.'}, {'ForeName': 'Uptal D', 'Initials': 'UD', 'LastName': 'Patel', 'Affiliation': 'Department of Medicine, Division of Nephrology, Duke University School of Medicine.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Crowley', 'Affiliation': 'Durham Veterans Affairs Center of Innovation to Accelerate Discovery and Practice Change (ADAPT).'}]",Medical care,['10.1097/MLR.0000000000001387']
2513,32846388,A Randomised Controlled Trial Examining the Effects of Self-Compassion Meditations on Women's Body Image.,"Although research has suggested that body image improves following self-compassion meditation training, studies have been limited due to the use of a wait-list control group. This study therefore compared the effects of self-compassion meditations to an active control group. Seventy young adult women (17-35 years) were randomly assigned to receive either self-compassion or nature-focused guided imagery meditations. Over one week, participants engaged in two meditations and completed pre- and post-test measures of trait self-compassion, body appreciation, body shame, and appearance-contingent self-worth. A mixed design analysis of variance revealed a main effect of time; women in both meditation groups demonstrated significant increases in self-compassion and body appreciation, and significant reductions in body shame. No effect was found for appearance-contingent self-worth. There were no interactions or main effects for group. Self-compassion may improve body image in women, although there was no evidence for an advantage of self-compassion over guided imagery meditations. Common elements between self-compassion and guided imagery may be a mechanism for improving body image. However, further research is warranted to isolate the effects of these meditations from other specific and non-specific treatment effects. (This study was pre-registered with the Australian New Zealand Clinical Trials Registry, ACTRN12618001814268).",2020,"Self-compassion may improve body image in women, although there was no evidence for an advantage of self-compassion over guided imagery meditations.","['Seventy young adult women (17-35 years', ""Women's Body Image""]","['Self-Compassion Meditations', 'self-compassion or nature-focused guided imagery meditations']","['self-compassion and body appreciation', 'body shame', 'trait self-compassion, body appreciation, body shame, and appearance-contingent self-worth']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005891', 'cui_str': 'Body image'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0349590', 'cui_str': 'Nature'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0036938', 'cui_str': 'Shame'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}]",70.0,0.0359798,"Self-compassion may improve body image in women, although there was no evidence for an advantage of self-compassion over guided imagery meditations.","[{'ForeName': 'Amy J', 'Initials': 'AJ', 'LastName': 'de Wet', 'Affiliation': 'School of Social Sciences, University of the Sunshine Coast, Locked Bag 4, Maroochydore DC, QLD, 4558, Australia. Electronic address: a_d088@student.usc.edu.au.'}, {'ForeName': 'Ben R', 'Initials': 'BR', 'LastName': 'Lane', 'Affiliation': 'Centre for Human Factors and Sociotechnical Systems, University of the Sunshine Coast, Locked Bag 4, Maroochydore DC, QLD, 4558, Australia. Electronic address: blane@usc.edu.au.'}, {'ForeName': 'Kate E', 'Initials': 'KE', 'LastName': 'Mulgrew', 'Affiliation': 'School of Social Sciences, University of the Sunshine Coast, Locked Bag 4, Maroochydore DC, QLD, 4558, Australia. Electronic address: kmulgrew@usc.edu.au.'}]",Body image,['10.1016/j.bodyim.2020.07.009']
2514,32820647,"Recruitment, retention, and adherence in a clinical trial: The Pediatric Heart Network's Marfan Trial experience.","BACKGROUND/AIMS


The Pediatric Heart Network Marfan Trial was a randomized trial comparing atenolol versus losartan on aortic root dilation in 608 children and young adults with Marfan syndrome. Barriers to enrollment included a limited pool of eligible participants, restrictive entry criteria, and a diverse age range that required pediatric and adult expertise. Retention was complicated by a 3-year commitment to a complex study and medication regimen. The Network partnered with the Marfan Foundation, bridging the community with the research. The aims of this study are to report protocol and medication adherence and associated predictive factors, and to describe recruitment and retention strategies.
METHODS


Recruitment, retention, and adherence to protocol activities related to the primary outcome were measured. Retention was measured by percentage of enrolled participants with 3-year outcome data. Protocol adherence was calculated by completion rates of study visits, ambulatory electrocardiography (Holter monitoring), and quarterly calls. Medication adherence was assessed by the number of tablets or the amount of liquid in bottles returned. Centers were ranked according to adherence (high, medium, and low tertiles). Recruitment, retention, and adherence questionnaires were completed by sites. Descriptive statistics summarized recruitment, retention, and adherence, as well as questionnaire results. Regression modeling assessed predictors of adherence.
RESULTS


Completion rates for visits, Holter monitors, and quarterly calls were 99%, 94%, and 96%, respectively. Primary outcome data at 3 years were obtained for 88% of participants. The mean percentage of medication taken was estimated at 89%. Site and age were associated with all measures of adherence. Young adult and African American participants had lower levels of adherence. Higher adherence sites employed more strategies; had more staffing resources, less key staff turnover, and more collaboration with referring providers; utilized the Foundation's resources; and used a greater number of strategies to recruit, retain, and promote protocol and medication adherence.
CONCLUSION


Overall adherence was excellent for this trial conducted within a National Institutes of Health-funded clinical trial network. Strategies specifically targeted to young adults and African Americans may have been beneficial. Many strategies employed by higher adherence sites are ones that any site could easily use, such as greeting families at non-study hospital visits, asking for family feedback, providing calendars for tracking schedules, and recommending apps for medication reminders. Additional key learnings include adherence differences by age, race, and site, the value of collaborative learning, and the importance of partnerships with patient advocacy groups. These lessons could shape recruitment, retention, and adherence to improve the quality of future complex trials involving rare conditions.",2020,"Higher adherence sites employed more strategies; had more staffing resources, less key staff turnover, and more collaboration with referring providers; utilized the Foundation's resources; and used a greater number of strategies to recruit, retain, and promote protocol and medication adherence.
","['young adults and African Americans', 'Young adult and African American participants', 'eligible participants, restrictive entry criteria, and a diverse age range that required pediatric and adult expertise', '608 children and young adults with Marfan syndrome']","['losartan', 'atenolol']","['Medication adherence', 'Recruitment, retention, and adherence questionnaires', 'Retention', 'mean percentage of medication taken', 'Completion rates for visits, Holter monitors, and quarterly calls', 'completion rates of study visits, ambulatory electrocardiography (Holter monitoring), and quarterly calls', 'Recruitment, retention, and adherence', 'Protocol adherence', 'Overall adherence', 'lower levels of adherence']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0024796', 'cui_str': ""Marfan's syndrome""}]","[{'cui': 'C0126174', 'cui_str': 'Losartan'}, {'cui': 'C0004147', 'cui_str': 'Atenolol'}]","[{'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C1290952', 'cui_str': 'Taking medication'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0013801', 'cui_str': 'Electrocardiography, Holter'}, {'cui': 'C0332179', 'cui_str': 'Trimonthly'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0013799', 'cui_str': 'Ambulatory ECG'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",608.0,0.169075,"Higher adherence sites employed more strategies; had more staffing resources, less key staff turnover, and more collaboration with referring providers; utilized the Foundation's resources; and used a greater number of strategies to recruit, retain, and promote protocol and medication adherence.
","[{'ForeName': 'Michelle S', 'Initials': 'MS', 'LastName': 'Hamstra', 'Affiliation': ""Heart Institute Administration, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Victoria L', 'Initials': 'VL', 'LastName': 'Pemberton', 'Affiliation': 'National Heart, Lung, and Blood Institute, NIH, Bethesda, MD, USA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Dagincourt', 'Affiliation': 'New England Research Institutes, Inc., Watertown, MA, USA.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Hollenbeck-Pringle', 'Affiliation': 'New England Research Institutes, Inc., Watertown, MA, USA.'}, {'ForeName': 'Felicia L', 'Initials': 'FL', 'LastName': 'Trachtenberg', 'Affiliation': 'New England Research Institutes, Inc., Watertown, MA, USA.'}, {'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Cnota', 'Affiliation': ""Heart Institute Administration, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Atz', 'Affiliation': 'Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Cappella', 'Affiliation': ""Ann and Robert H. Lurie Children's Hospital, Chicago, IL, USA.""}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'De Nobele', 'Affiliation': 'Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Josephine', 'Initials': 'J', 'LastName': 'Grima', 'Affiliation': 'The Marfan Foundation, Port Washington, NY, USA.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'King', 'Affiliation': ""Harvard Medical School, Boston Children's Hospital, Boston, MA, USA.""}, {'ForeName': 'Rosalind', 'Initials': 'R', 'LastName': 'Korsin', 'Affiliation': ""Children's Hospital of New York, New York, NY, USA.""}, {'ForeName': 'Linda M', 'Initials': 'LM', 'LastName': 'Lambert', 'Affiliation': ""Primary Children's Hospital, University of Utah, Salt Lake City, UT, USA.""}, {'ForeName': 'Meghan K', 'Initials': 'MK', 'LastName': 'MacNeal', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Larry W', 'Initials': 'LW', 'LastName': 'Markham', 'Affiliation': ""The Monroe Carell Jr. Children's Hospital at Vanderbilt, Nashville, TN, USA.""}, {'ForeName': 'Gretchen', 'Initials': 'G', 'LastName': 'MacCarrick', 'Affiliation': 'Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Donna M', 'Initials': 'DM', 'LastName': 'Sylvester', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Walter', 'Affiliation': 'Hospital for Sick Children, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Mingfen', 'Initials': 'M', 'LastName': 'Xu', 'Affiliation': 'Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Ronald V', 'Initials': 'RV', 'LastName': 'Lacro', 'Affiliation': ""Harvard Medical School, Boston Children's Hospital, Boston, MA, USA.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Clinical trials (London, England)",['10.1177/1740774520945988']
2515,32825556,"Acute Epigallocatechin-3-Gallate Supplementation Alters Postprandial Lipids after a Fast-Food Meal in Healthy Young Women: A Randomized, Double-Blind, Placebo-Controlled Crossover Study.","A high-fat fast-food meal negatively impacts postprandial metabolism even in healthy young people. In experimental studies, epigallocatechin-3-gallate (EGCG), a bioactive compound present in green tea, has been described as a potent natural inhibitor of fatty acid synthase. Thus, we sought to evaluate the effects of acute EGCG supplementation on postprandial lipid profile, glucose, and insulin levels following a high-fat fast-food meal. Fourteen healthy young women 21 ± 1 years and body mass index 21.4 ± 0.41 kg/m 2  were enrolled in a randomized, double-blind, placebo-controlled crossover study. Participants ingested capsules containing 800 mg EGCG or placebo immediately before a typical fast-food meal rich in saturated fatty acids. Blood samples were collected at baseline and then at 90 and 120 min after the meal. The EGCG treatment attenuated postprandial triglycerides ( p  = 0.029) and decreased high-density lipoprotein cholesterol (HDL-c) ( p  = 0.016) at 120 min. No treatment × time interaction was found for total cholesterol, low-density lipoprotein (LDL-c), and glucose or insulin levels. The incremental area under the curve (iAUC) for glucose was decreased by EGCG treatment ( p  < 0.05). No difference was observed in the iAUC for triglycerides and HDL-c. In healthy young women, acute EGCG supplementation attenuated postprandial triglycerides and glucose but negatively impacted HDL-c following a fast-food meal.",2020,"No treatment × time interaction was found for total cholesterol, low-density lipoprotein (LDL-c), and glucose or insulin levels.","['Healthy Young Women', 'healthy young people', 'Fourteen healthy young women 21 ± 1 years and body mass index 21.4 ± 0.41 kg/m 2', 'healthy young women']","['Placebo', 'EGCG', 'acute EGCG supplementation', 'EGCG or placebo', 'epigallocatechin-3-gallate (EGCG', 'Acute Epigallocatechin-3-Gallate Supplementation', 'placebo']","['incremental area under the curve (iAUC) for glucose', 'high-density lipoprotein cholesterol (HDL-c', 'iAUC for triglycerides and HDL-c', 'postprandial triglycerides', 'Blood samples', 'postprandial lipid profile, glucose, and insulin levels', 'total cholesterol, low-density lipoprotein (LDL-c), and glucose or insulin levels', 'postprandial triglycerides and glucose']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0059438', 'cui_str': 'epigallocatechin gallate'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}]",14.0,0.329711,"No treatment × time interaction was found for total cholesterol, low-density lipoprotein (LDL-c), and glucose or insulin levels.","[{'ForeName': 'Alcides C', 'Initials': 'AC', 'LastName': 'de Morais Junior', 'Affiliation': 'Clinical and Sports Nutrition Research Laboratory (LABINCE), Faculty of Nutrition, Federal University of Goiás (UFG), Goiania 74690-900, GO, Brazil.'}, {'ForeName': 'Raquel M', 'Initials': 'RM', 'LastName': 'Schincaglia', 'Affiliation': 'Clinical and Sports Nutrition Research Laboratory (LABINCE), Faculty of Nutrition, Federal University of Goiás (UFG), Goiania 74690-900, GO, Brazil.'}, {'ForeName': 'Marisa', 'Initials': 'M', 'LastName': 'Passarelli', 'Affiliation': 'Laboratório de Lípides (LIM 10), Hospital das Clínicas (HCFMUSP), Faculdade de Medicina da Universidade de Sao Paulo, Sao Paulo 05403-900, Brazil.'}, {'ForeName': 'Gustavo D', 'Initials': 'GD', 'LastName': 'Pimentel', 'Affiliation': 'Clinical and Sports Nutrition Research Laboratory (LABINCE), Faculty of Nutrition, Federal University of Goiás (UFG), Goiania 74690-900, GO, Brazil.'}, {'ForeName': 'João F', 'Initials': 'JF', 'LastName': 'Mota', 'Affiliation': 'Clinical and Sports Nutrition Research Laboratory (LABINCE), Faculty of Nutrition, Federal University of Goiás (UFG), Goiania 74690-900, GO, Brazil.'}]",Nutrients,['10.3390/nu12092533']
2516,32822633,"Safety, tolerability, and efficacy of orally administered atogepant for the prevention of episodic migraine in adults: a double-blind, randomised phase 2b/3 trial.","BACKGROUND


Atogepant is an orally administered, small-molecule, calcitonin gene-related peptide (CGRP) receptor antagonist under investigation for treatment of migraine. We aimed to examine a range of oral doses for safety, tolerability, and efficacy for the preventive treatment of migraine.
METHODS


In this double-blind, phase 2b/3 trial, adults (aged 18-75 years), with a history (≥1 year) of migraine and 4-14 migraine days per month, were randomly assigned 2:1:2:2:1:1 (by means of a sequence generated by the statistical programming department of the sponsor, and operationalised through an automated interactive web-based response system) to receive placebo or atogepant 10 mg once daily, 30 mg once daily, 60 mg once daily, 30 mg twice daily, or 60 mg twice daily, in matching capsules. Participants, site personnel, and all study sponsor personnel were masked to treatment allocations. The study was done in 78 academic and private practice settings in the USA. The primary outcome was change from baseline in monthly migraine days across 12 weeks of treatment using a modified intention-to-treat approach. The overall type I error rate for multiple comparisons across active treatment doses was controlled at the 0·05 level by means of a graphic approach. The main outcomes to assess safety and tolerability were adverse event recordings. The trial is registered with ClinicalTrials.gov, NCT02848326 and is completed.
FINDINGS


Between Sept 6, 2016, and April 23, 2018, of 1772 individuals screened, 834 were randomly assigned and 825 received one dose or more of study medication: 186 received placebo, 93 atogepant 10 mg once daily, 183 atogepant 30 mg once daily, 186 atogepant 60 mg once daily, 86 atogepant 30 mg twice daily, and 91 atogepant 60 mg twice daily. Overall, 714 (87%) of 825 participants were female, 628 (76%) were white, median migraine duration was 17·5 years (IQR 10·0-28·0), and 232 (28%) had previously used preventive treatment. The primary efficacy analysis included 795 patients: 178 received placebo, 92 atogepant 10 mg once daily, 182 atogepant 30 mg once daily, 177 atogepant 60 mg once daily, 79 atogepant 30 mg twice daily, and 87 atogepant 60 mg twice daily. Across the 12-week treatment period, all five atogepant groups showed significant least-squares mean (SE) change from baseline in mean monthly migraine days versus placebo: atogepant 10 mg once daily -4·0 (0·3; p=0·024), 30 mg once daily -3·8 (0·2; p=0·039), 60 mg once daily -3·6 (0·2; p=0·039), 30 mg twice daily -4·2 (0·4; p=0·0034), and 60 mg twice daily -4·1 (0·3; p=0·0031); placebo -2·9 (0·2). The most common treatment-emergent adverse events (TEAEs) across all groups were nausea (range 5% [5/93] for 10 mg once daily to 12% [22/186] for 60 mg once daily vs 5% [9/186] for placebo) and fatigue (1% [1/93] for 10 mg once daily to 10% [9/91] for 60 mg twice daily vs 3% [6/186] for placebo). Treatment-related TEAE frequency ranged from 18% (17/93) for 10 mg once daily to 26% (24/91) for 60 mg twice daily, versus 16% (30/186) for placebo. Seven participants reported a total of eight serious TEAEs (two participants each in the placebo, 30 mg once-daily, and 60 mg once-daily groups, and one participant in the 10 mg once-daily group). TEAEs leading to discontinuation were reported in 33 (5%) of 639 atogepant participants and 5 (3%) of 186 of those randomised to placebo. All serious TEAEs were unrelated to treatment.
INTERPRETATION


All doses of oral atogepant were associated with a significant decrease in monthly migraine days over 12 weeks compared with placebo. Atogepant was safe and well tolerated over 12 weeks, supporting its phase 3 development for the preventive treatment of migraine.
FUNDING


Allergan (before its acquisition by AbbVie).",2020,All doses of oral atogepant were associated with a significant decrease in monthly migraine days over 12 weeks compared with placebo.,"['714 (87%) of 825 participants were female, 628 (76%) were white, median migraine duration was 17·5 years (IQR 10·0-28·0), and 232 (28%) had previously used preventive treatment', 'adults (aged 18-75 years), with a history (≥1 year) of migraine and 4-14 migraine days per month', 'Between Sept 6, 2016, and April 23, 2018, of 1772 individuals screened, 834 were randomly assigned and 825 received one dose or more of study medication: 186 received', 'episodic migraine in adults', '795 patients: 178 received', '78 academic and private practice settings in the USA']",['placebo'],"['Safety, tolerability, and efficacy', 'fatigue', 'least-squares mean (SE) change', 'safety and tolerability', 'safety, tolerability, and efficacy', 'monthly migraine days', 'nausea', 'safe and well tolerated']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0556971', 'cui_str': 'days/month'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C4760993', 'cui_str': 'Episodic migraine'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033174', 'cui_str': 'Private Practice'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0023189', 'cui_str': 'Analysis, Least-Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}]",834.0,0.533574,All doses of oral atogepant were associated with a significant decrease in monthly migraine days over 12 weeks compared with placebo.,"[{'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Goadsby', 'Affiliation': ""NIHR-Wellcome Trust King's Clinical Research Facility, SLaM Biomedical Research Centre, King's College London, London, UK. Electronic address: UKpeter.goadsby@kcl.ac.uk.""}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Dodick', 'Affiliation': 'Mayo Clinic, Phoenix, AZ, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Ailani', 'Affiliation': 'Medstar Georgetown University Hospital, Washington DC, USA.'}, {'ForeName': 'Joel M', 'Initials': 'JM', 'LastName': 'Trugman', 'Affiliation': 'AbbVie, Madison, NJ, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Finnegan', 'Affiliation': 'AbbVie, Madison, NJ, USA.'}, {'ForeName': 'Kaifeng', 'Initials': 'K', 'LastName': 'Lu', 'Affiliation': 'AbbVie, Madison, NJ, USA.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Szegedi', 'Affiliation': 'AbbVie, Madison, NJ, USA.'}]",The Lancet. Neurology,['10.1016/S1474-4422(20)30234-9']
2517,32822653,The plasma levels of atrial natriuretic peptide and brain natriuretic peptide in type 2 diabetes treated with sodium-glucose cotransporter-2 inhibitor.,"PURPOSE


The aim of this study was to determine the levels of atrial natriuretic peptide (ANP) and brain natriuretic peptide (BNP) after treatment with sodium-glucose cotransporter-2 (SGLT2) inhibitor or dipeptidyl peptidase-4 (DPP4) inhibitor in patients with type-2 diabetes inadequately controlled by insulin, and to determine whether variation in ANP levels can explain favorable cardiovascular outcome.
METHODS


We enrolled 56 patients, aged 18-80years, with type-2 diabetes inadequately controlled by insulin: i.e., HbA1c level 7.5-10.5% despite at least 8weeks' injectable insulin at a stable mean dose of 20-150IU daily, with or without no more than two oral antidiabetic agents.
FINDINGS


The 56 patients were randomized between 3 treatment groups: SGLT2 inhibitor (n=18), DPP4 inhibitor (n=19) and placebo (n=19). Patients who received SGLT2 inhibitor or DPP4 inhibitor treatment all showed significantly lower HbA1c levels, fasting blood glucose (FBG) levels and systolic blood pressure at 24weeks than controls. SGLT2 inhibitor treatment decreased ANP levels, BNP levels, systolic blood pressure and weight compared with placebo. Compared to those receiving DPP4 inhibitor, patients receiving SGLT2 inhibitor showed lower HbA1c levels (7.01 vs. 7.58%; P=0.03), ANP levels (28.41 vs. 43.03 pg/mL; P=0.00) and weight (66.14 vs. 71.76 kg; P=0.04) at 24weeks after adjusting for baseline values. The SGLT2 inhibitor group showed higher sodium concentrations than the placebo and DPP4 inhibitor groups (145.89 vs. 143.89 and 144.79 mmol/L, respectively; P=0.00 and P=0.04) at 24 weeks. ANP and BNP levels did not significantly correlate with HbA1c and blood glucose levels.
IMPLICATIONS


These results indicated that SGLT2 inhibitors may be superior to DPP4 inhibitors in reducing risk of cardiovascular disease in diabetic patients. The major study limitation was the small number of patients per group, which should be enlarged in further research.",2020,"Patients who received SGLT2 inhibitor or DPP4 inhibitor treatment all had significantly decreased HbA1c levels, fasting blood glucose (FBG) levels and systolic blood pressure at 24 weeks compared with patients treated with a placebo.","['patients with diabetes', '56 patients with type 2 diabetes mellitus that was inadequately controlled with insulin; the subjects were all 18∼80 years of age', 'A total of 56 patients', 'patients with type 2 diabetes mellitus', 'patients who still experienced inadequate glycaemic control (HbA1c levels of 7.5∼10.5 %) were recruited']","['DPP4 inhibitor', 'placebo', 'SGLT2 inhibitor', 'SGLT2', 'sodium-glucose cotransporter-2 inhibitor', 'SGLT2 inhibitor or DPP4 inhibitor', 'injectable insulin daily combined with or without no more than two oral antidiabetic agents']","['ANP and BNP levels', 'weight', 'levels of atrial natriuretic peptide (ANP) and brain natriuretic peptide (BNP', 'sodium concentrations', 'plasma levels of atrial natriuretic peptide and brain natriuretic peptide', 'ANP levels', 'HbA1c and blood glucose levels', 'HbA1c levels, fasting blood glucose (FBG) levels and systolic blood pressure', 'lower HbA1c levels', 'ANP levels, BNP levels, systolic blood pressure and weight']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3273807', 'cui_str': 'SGLT2 Inhibitors'}, {'cui': 'C1505133', 'cui_str': 'SLC5A2 protein, human'}, {'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0935929', 'cui_str': 'Antidiabetic agent'}]","[{'cui': 'C0027481', 'cui_str': 'A-type natriuretic peptide'}, {'cui': 'C1095989', 'cui_str': 'Brain natriuretic peptide measurement'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",56.0,0.0715293,"Patients who received SGLT2 inhibitor or DPP4 inhibitor treatment all had significantly decreased HbA1c levels, fasting blood glucose (FBG) levels and systolic blood pressure at 24 weeks compared with patients treated with a placebo.","[{'ForeName': 'Xiu', 'Initials': 'X', 'LastName': 'Feng', 'Affiliation': 'Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University, 68, Changle Road, Qinhuai District, Nanjing, Jiangsu Province, China. Electronic address: show_clancy@foxmail.com.'}, {'ForeName': 'Qingwei', 'Initials': 'Q', 'LastName': 'Gu', 'Affiliation': 'Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University, 68, Changle Road, Qinhuai District, Nanjing, Jiangsu Province, China. Electronic address: gqw9299@163.com.'}, {'ForeName': 'Gu', 'Initials': 'G', 'LastName': 'Gao', 'Affiliation': 'Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University, 68, Changle Road, Qinhuai District, Nanjing, Jiangsu Province, China. Electronic address: feifeigalt@163.com.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Yuan', 'Affiliation': 'Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University, 68, Changle Road, Qinhuai District, Nanjing, Jiangsu Province, China. Electronic address: happy_yuanlu@126.com.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University, 68, Changle Road, Qinhuai District, Nanjing, Jiangsu Province, China. Electronic address: shygu@njmu.edu.cn.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University, 68, Changle Road, Qinhuai District, Nanjing, Jiangsu Province, China. Electronic address: zhangying932@163.com.'}]",Annales d'endocrinologie,['10.1016/j.ando.2020.07.1113']
2518,32721580,Hepatic Disorders With the Use of Remdesivir for Coronavirus 2019.,"Remdesivir is a nucleotide analog prodrug with antiviral activity against a broad spectrum of human coronavirus in cell cultures and mouse models including severe acute respiratory syndrome-associated coronavirus 2. Recently, the Food and Drug Agency (FDA) and the European Medicines Agency (EMA) recommended remdesivir for the treatment of patients hospitalized with severe coronavirus disease 2019 (COVID-19) infection. 1 , 2  In the remdesivir clinical development program, some cases have raised concerns regarding potential hepatobiliary disorders associated with remdesivir, including in healthy volunteers and patients with COVID-19. 3  In cohort studies of patients hospitalized for severe COVID-19 who were treated with compassionate-use remdesivir, elevated hepatic enzymes were the most frequent adverse drug reaction reported. 4 , 5  In the first randomized, double-blind, placebo-controlled clinical trial assessing the effect of intravenous remdesivir in adults admitted to hospital with severe COVID-19 (n = 237), a higher proportion of remdesivir recipients than placebo recipients had dosing prematurely stopped by the investigators because of adverse events including aminotransferase or bilirubin increases (3 versus 0). 6  Although there is no signal from the available data of severe hepatotoxicity or drug-induced liver injury in clinical trials, the number of patients exposed to remdesivir was too limited. Therefore, there is an urgent need to investigate the hepatic safety profile associated with remdesivir in COVID-19 patients.",2020,Remdesivir is a nucleotide analog prodrug with antiviral activity against a broad spectrum of human coronavirus in cell cultures and mouse models including severe acute respiratory syndrome-associated coronavirus 2.,"['adults admitted to hospital with severe COVID-19 (n\xa0= 237', 'healthy volunteers and patients with COVID-19', 'recipients had dosing prematurely stopped by the investigators because of adverse events including aminotransferase or bilirubin increases (3 versus 0', 'patients hospitalized with severe coronavirus disease 2019 (COVID-19) infection']",['placebo'],[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferase'}, {'cui': 'C0311468', 'cui_str': 'Increased bilirubin level'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.110012,Remdesivir is a nucleotide analog prodrug with antiviral activity against a broad spectrum of human coronavirus in cell cultures and mouse models including severe acute respiratory syndrome-associated coronavirus 2.,"[{'ForeName': 'François', 'Initials': 'F', 'LastName': 'Montastruc', 'Affiliation': 'Department of Medical and Clinical Pharmacology, Centre of PharmacoVigilance and Pharmacoepidemiology, Toulouse University Hospital (CHU), Faculty of Medicine, Toulouse, France; INSERM, UMR 1027 Pharmacoepidemiology, Assessment of Drug Utilization and Drug Safety, CIC 1426 - University Paul Sabatier Toulouse, Toulouse, France. Electronic address: francois.montastruc@univ-tlse3.fr.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Thuriot', 'Affiliation': 'Department of Medical and Clinical Pharmacology, Centre of PharmacoVigilance and Pharmacoepidemiology, Toulouse University Hospital (CHU), Faculty of Medicine, Toulouse, France.'}, {'ForeName': 'Geneviève', 'Initials': 'G', 'LastName': 'Durrieu', 'Affiliation': 'Department of Medical and Clinical Pharmacology, Centre of PharmacoVigilance and Pharmacoepidemiology, Toulouse University Hospital (CHU), Faculty of Medicine, Toulouse, France; INSERM, UMR 1027 Pharmacoepidemiology, Assessment of Drug Utilization and Drug Safety, CIC 1426 - University Paul Sabatier Toulouse, Toulouse, France.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2020.07.050']
2519,32830617,"The Efficiency, Efficacy, and Retention of Task Practice in Chronic Stroke.","In motor skill learning, larger doses of practice lead to greater efficacy of practice, lower efficiency of practice, and better long-term retention. Whether such learning principles apply to motor practice after stroke is unclear. Here, we developed novel mixed-effects models of the change in the perceived quality of arm movements during and following task practice. The models were fitted to data from a recent randomized controlled trial of the effect of dose of task practice in chronic stroke. Analysis of the models' learning and retention rates demonstrated an increase in efficacy of practice with greater doses, a decrease in efficiency of practice with both additional dosages and additional bouts of training, and fast initial decay following practice. Two additional effects modulated retention: a positive ""self-practice"" effect, and a negative effect of dose. Our results further suggest that for patients with sufficient arm use post-practice, self-practice will further improve use.",2020,"Analysis of the models' learning and retention rates demonstrated an increase in efficacy of practice with greater doses, a decrease in efficiency of practice with both additional dosages and additional bouts of training, and fast initial decay following practice.",['chronic stroke'],[],"['Efficiency, Efficacy, and Retention of Task Practice in Chronic Stroke']","[{'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}]",[],"[{'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}]",,0.0577901,"Analysis of the models' learning and retention rates demonstrated an increase in efficacy of practice with greater doses, a decrease in efficiency of practice with both additional dosages and additional bouts of training, and fast initial decay following practice.","[{'ForeName': 'Chunji', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Neuroscience Graduate Program, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Carolee', 'Initials': 'C', 'LastName': 'Winstein', 'Affiliation': 'Biokinesiology and Physical Therapy, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'David Z', 'Initials': 'DZ', 'LastName': ""D'Argenio"", 'Affiliation': 'Biomedical Engineering, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Schweighofer', 'Affiliation': 'Biokinesiology and Physical Therapy, University of Southern California, Los Angeles, CA, USA.'}]",Neurorehabilitation and neural repair,['10.1177/1545968320948609']
2520,32840891,Randomized controlled trial on the effectiveness of web-based Genomics Nursing Education Intervention for undergraduate nursing students: a study protocol.,"AIM


To describe a randomized controlled trial protocol that will evaluate the effectiveness of two web-based genomic nursing education interventions.
BACKGROUND


Preparing future nurses to be competent in genetic and genomic concepts is fundamental to ensure appropriate clinical application. However, genetics-genomics concepts are still new in the field of nursing. Little is known about what type and kind of web-based nursing education is effective in improving the knowledge of nursing students. To address these knowledge gaps, a web-based 'Genomic Nursing Education Intervention' will be developed and compared with an existing online education programme.
DESIGN


A randomized controlled trial of two groups with pre-test and repeated posttesting.
METHODS


The Genomic Nursing Concept Inventory, a validated tool, will be used to assess the genetics-genomics knowledge of nursing students. Participants will be randomly allocated to either a control or an intervention group. The control group will receive the standard web-based nursing education, while the intervention group will receive a newly developed web-based education intervention. Outcome measures include the students' knowledge level of nursing genetics-genomics concepts. Participants will be retested at 3 and 6 months.
CONCLUSION


Current evidence shows that ensuring nurses have adequate education in genetic-genomic concepts is challenging. This study will demonstrate which of two web-based nursing education methods is more effective in teaching genetic-genomic concepts. This research project will better prepare the nursing profession in their careers for the emerging advance technologies in genetics-genomics and personalized health care.
IMPACT


Current evidence shows major challenges in ensuring that nurses have adequate education in genetics-genomics concepts. Less is known about what approaches to web-based education are effective to improve the knowledge gaps of nursing students in genetics-genomics concepts. This study will determine which type of web-based nursing education is effective in improving the genetics-genomics knowledge of nursing students. This research project will help better prepare nurses in dealing with advances in genetics-genomics in their careers.
TRIAL REGISTRATION


This study is registered in ClinicalTrials.gov (ID number NCT03963687) https://clinicaltrials.gov/show/NCT03963687.",2020,Little is known about what type and kind of web-based nursing education is effective in improving the knowledge of nursing students.,"['nursing students', 'undergraduate nursing students']","['standard web-based nursing education, while the intervention group will receive a newly developed web-based education intervention', 'web-based Genomics Nursing Education Intervention']","[""students' knowledge level of nursing genetics-genomics concepts""]","[{'cui': 'C0038496', 'cui_str': 'Student nurse'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013636', 'cui_str': 'Nursing Education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0017428', 'cui_str': 'Genome'}]","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0871796', 'cui_str': 'Knowledge level'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0017296', 'cui_str': 'Gene therapy'}, {'cui': 'C0017428', 'cui_str': 'Genome'}]",,0.117689,Little is known about what type and kind of web-based nursing education is effective in improving the knowledge of nursing students.,"[{'ForeName': 'Anndra Margareth', 'Initials': 'AM', 'LastName': 'Dumo', 'Affiliation': 'University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'Bobbi', 'Initials': 'B', 'LastName': 'Laing', 'Affiliation': 'School of Nursing, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Anecita Gigi', 'Initials': 'AG', 'LastName': 'Lim', 'Affiliation': 'School of Nursing, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Erlinda', 'Initials': 'E', 'LastName': 'Palaganas', 'Affiliation': 'University of the Philippines, Baguio, Philippines.'}, {'ForeName': 'Peter James', 'Initials': 'PJ', 'LastName': 'Abad', 'Affiliation': 'College of Nursing, University of the Philippines, Manila, Philippines.'}, {'ForeName': 'Ofelia', 'Initials': 'O', 'LastName': 'Valdehueza', 'Affiliation': 'Don Mariano Marcos Memorial State University, La Union, Philippines.'}, {'ForeName': 'Marjo', 'Initials': 'M', 'LastName': 'Palovaara', 'Affiliation': 'Jyväskylä University of Applied Sciences, Jyväskylä, Finland.'}, {'ForeName': 'Hannele', 'Initials': 'H', 'LastName': 'Saunders', 'Affiliation': 'South-Eastern Finland University of Applied Sciences, Kouvola, Finland.'}, {'ForeName': 'Matti', 'Initials': 'M', 'LastName': 'Estola', 'Affiliation': 'University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Mandysova', 'Affiliation': 'Department of Nursing, Faculty of Health Studies, University of Pardubice, Pardubice, Czech Republic.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Maguire', 'Affiliation': 'Faculty of Health, University of Technology, Sydney, Australia.'}, {'ForeName': 'Linda D', 'Initials': 'LD', 'LastName': 'Ward', 'Affiliation': 'Clemson University School of Nursing, Clemson, SC, USA.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Carlberg', 'Affiliation': 'University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'Katri', 'Initials': 'K', 'LastName': 'Vehviläinen-Julkunen', 'Affiliation': 'University of Eastern Finland, Kuopio, Finland.'}]",Journal of advanced nursing,['10.1111/jan.14477']
2521,32833477,Protocol for a mechanistic study of mindfulness based cognitive therapy during pregnancy.,"OBJECTIVE


Preventive interventions for postpartum depression (PPD) are critical for women at elevated risk of PPD. Mindfulness based cognitive therapy - perinatal depression (MBCT-PD) is a preventive intervention that has been shown to reduce risk for PPD in women with a prior history of depression. The objective of this clinical trial is to examine two potential mechanisms of action of MBCT-PD, emotion regulation and cognitive control, using behavioral and neuroimaging methods.
METHOD


This baseline protocol describes a randomized control trial (RCT) with two arms, MBCT-PD and treatment as usual (TAU). We plan on enrolling 74 females with a prior history of a major depressive episode, with 37 participants randomized to each arm. Participants in the MBCT-PD arm will receive MBCT-PD during pregnancy, and the TAU group will receive standard prenatal care. All participants will complete the Center for Epidemiological Studies Depression Scale - Revised (CESD-R), Emotion Regulation Questionnaire (ERQ), and classic Stroop task at multiple points from pregnancy through six months postpartum. Participants will also complete an fMRI scan at six weeks postpartum.
RESULTS


All primary outcomes are collected at six weeks postpartum. Primary behavioral outcomes include: depressive symptoms on the CESD-R, cognitive reappraisal on the ERQ, and Stroop task performance. In parallel, the primary neurobiological outcomes include whole-brain activation during fMRI tasks when participants 1) regulate emotional responding and 2) engage cognitive control.
CONCLUSIONS


This results of this innovative RCT will help identify potential behavioral and neurobiological mechanisms of action of preventive interventions for PPD for in-depth examination in larger scale RCTs. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"Primary behavioral outcomes include: depressive symptoms on the CESD-R, cognitive reappraisal on the ERQ, and Stroop task performance.","['women with a prior history of depression', 'women at elevated risk of PPD', '74 females with a prior history of a major depressive episode, with 37 participants randomized to each arm']","['Mindfulness based cognitive therapy - perinatal depression (MBCT-PD', 'MBCT-PD and treatment as usual (TAU']","['whole-brain activation during fMRI tasks when participants 1) regulate emotional responding and 2) engage cognitive control', 'Epidemiological Studies Depression Scale - Revised (CESD-R), Emotion Regulation Questionnaire (ERQ), and classic Stroop task', 'depressive symptoms on the CESD-R, cognitive reappraisal on the ERQ, and Stroop task performance']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0455503', 'cui_str': 'H/O: depression'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0221074', 'cui_str': 'Postpartum depression'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0024517', 'cui_str': 'Major depression, single episode'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0559477', 'cui_str': 'Perinatal asphyxia'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002783', 'cui_str': 'Studies, Epidemiologic'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0043208', 'cui_str': ""Wolman's disease""}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439658', 'cui_str': 'Classic'}, {'cui': 'C2718024', 'cui_str': 'Stroop Task'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",74.0,0.123274,"Primary behavioral outcomes include: depressive symptoms on the CESD-R, cognitive reappraisal on the ERQ, and Stroop task performance.","[{'ForeName': 'Kristen L', 'Initials': 'KL', 'LastName': 'Mackiewicz Seghete', 'Affiliation': 'Department of Psychiatry, Oregon Health & Science University.'}, {'ForeName': 'Alice M', 'Initials': 'AM', 'LastName': 'Graham', 'Affiliation': 'Department of Psychiatry, Oregon Health & Science University.'}, {'ForeName': 'Jodi A', 'Initials': 'JA', 'LastName': 'Lapidus', 'Affiliation': 'OHSU-PSU School of Public Health, Oregon Health & Science University.'}, {'ForeName': 'Evelyn L A', 'Initials': 'ELA', 'LastName': 'Jackson', 'Affiliation': 'Department of Psychiatry, Oregon Health & Science University.'}, {'ForeName': 'Olivia J', 'Initials': 'OJ', 'LastName': 'Doyle', 'Affiliation': 'Department of Behavioral Neuroscience, Oregon Health & Science University.'}, {'ForeName': 'Alicia B', 'Initials': 'AB', 'LastName': 'Feryn', 'Affiliation': 'OHSU-PSU School of Public Health, Oregon Health & Science University.'}, {'ForeName': 'Lucille A', 'Initials': 'LA', 'LastName': 'Moore', 'Affiliation': 'Department of Neurology, Oregon Health & Science University.'}, {'ForeName': 'Sherryl H', 'Initials': 'SH', 'LastName': 'Goodman', 'Affiliation': 'Department of Psychology, Emory University.'}, {'ForeName': 'Sona', 'Initials': 'S', 'LastName': 'Dimidjian', 'Affiliation': 'Department of Psychology and Neuroscience, University of Colorado Boulder.'}]","Health psychology : official journal of the Division of Health Psychology, American Psychological Association",['10.1037/hea0000870']
2522,32835443,Unilateral versus bilateral sacral neuromodulation test in the treatment of refractory idiopathic overactive bladder: A randomized controlled pilot trial.,"AIM


To compare treatment success rate in terms of improvement of bladder overactivity between unilateral and bilateral sacral neuromodulation testing.
METHODS


A multicentric, parallel, randomized, open pilot trial (October 2012-September 2017) was conducted. Participants presented primary overactive bladder resistant to first-line treatments. Patients were excluded in case of secondary bladder, pelvic, or neurological condition. Patients were randomized between bilateral testing (n = 28) or unilateral testing (n = 27), to determine the best functional response before final implantation. The primary outcome was the rate of patients presenting at least 50% of clinical improvement at 1 month on urinary frequency, number of urge incontinence episodes or number of urinary urgency episodes. Symptom severity, implantation success rate, uroflowmetry, device tolerance, complications, and quality of life were also assessed.
RESULTS


Fifty-five patients have been included. The rate of patients presenting at least one significant clinical improvement at month 1 was 62% in the bilateral group versus 84% in the unilateral group (P = .0891), RR = 0.74 (0.51; 1.07). There was no significant difference between bilateral and unilateral groups in terms of improvement of urinary frequency (0% and 17%; P = .1115), number of urge incontinence episodes (52% and 63%; P = .4929) or number of urinary urgency episodes (57% and 74%; P = .2411). More complications were reported in the bilateral group than in the unilateral group (9 [47%] vs 4 [16%], respectively; P = .0239).
CONCLUSION


Systematic bilateral sacral neuromodulation testing before final implantation did not appear to increase success rate compared with unilateral stimulation in the treatment of overactive bladder.",2020,"There was no significant difference between bilateral and unilateral groups in terms of improvement of urinary frequency (0% and 17%; P = .1115), number of urge incontinence episodes (52% and 63%; P = .4929) or number of urinary urgency episodes (57% and 74%; P = .2411).","['Participants presented primary overactive bladder resistant to first-line treatments', 'Patients were excluded in case of secondary bladder, pelvic, or neurological condition', 'Fifty-five patients have been included', 'refractory idiopathic overactive bladder']","['bilateral testing (n\u2009=\u200928) or unilateral testing', 'Unilateral versus bilateral sacral neuromodulation test']","['rate of patients presenting at least one significant clinical improvement', 'number of urge incontinence episodes', 'success rate', 'number of urinary urgency episodes', 'urinary frequency', 'Symptom severity, implantation success rate, uroflowmetry, device tolerance, complications, and quality of life', 'urinary frequency, number of urge incontinence episodes or number of urinary urgency episodes', 'More complications', 'rate of patients presenting at least 50% of clinical improvement']","[{'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C1708063', 'cui_str': 'First line treatment'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0005682', 'cui_str': 'Urinary bladder structure'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0450382', 'cui_str': '55'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0036037', 'cui_str': 'Bone structure of sacrum'}, {'cui': 'C0394674', 'cui_str': 'Neurostimulation/modulation'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0150045', 'cui_str': 'Urge incontinence of urine'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0085606', 'cui_str': 'Urgent desire to urinate'}, {'cui': 'C0042023', 'cui_str': 'Increased frequency of urination'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0200008', 'cui_str': 'Uroflowmetry'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.134808,"There was no significant difference between bilateral and unilateral groups in terms of improvement of urinary frequency (0% and 17%; P = .1115), number of urge incontinence episodes (52% and 63%; P = .4929) or number of urinary urgency episodes (57% and 74%; P = .2411).","[{'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Wagner', 'Affiliation': 'Department of Urology and Andrology, CHU Nîmes, Univ Montpellier, Nîmes, France.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Alonso', 'Affiliation': 'Department of Biostatistics Clinical Epidemiology, Public Health and Innovation in Methodology (BESPIM), CHU Nîmes, Univ Montpellier, Nîmes, France.'}, {'ForeName': 'Loïc', 'Initials': 'L', 'LastName': 'Le Normand', 'Affiliation': 'Department of Urology and Andrology, CHU Nantes, Nantes, France.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Faix', 'Affiliation': 'Department of Urology, Clinique Beau Soleil, Montpellier, France.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Kabani', 'Affiliation': 'Department of Biostatistics Clinical Epidemiology, Public Health and Innovation in Methodology (BESPIM), CHU Nîmes, Univ Montpellier, Nîmes, France.'}, {'ForeName': 'Christel', 'Initials': 'C', 'LastName': 'Castelli', 'Affiliation': 'Department of Biostatistics Clinical Epidemiology, Public Health and Innovation in Methodology (BESPIM), CHU Nîmes, Univ Montpellier, Nîmes, France.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Gamé', 'Affiliation': 'Department of Urology, University Hospital of Toulouse, Toulouse, France.'}, {'ForeName': 'Jean-Nicolas', 'Initials': 'JN', 'LastName': 'Cornu', 'Affiliation': 'Department of Urology, University Hospital of Rouen, Rouen, France.'}, {'ForeName': 'Elsa', 'Initials': 'E', 'LastName': 'Bey', 'Affiliation': 'Department of Urology and Andrology, CHU Nîmes, Univ Montpellier, Nîmes, France.'}]",Neurourology and urodynamics,['10.1002/nau.24476']
2523,32836188,Comparison of low and high inspiratory oxygen fraction added to lung-protective ventilation on postoperative pulmonary complications after abdominal surgery: A randomized controlled trial.,"STUDY OBJECTIVE


Intraoperative lung-protective ventilation strategy has been recommended to reduce postoperative pulmonary complications (PPCs). However, the role of inspiratory oxygen fraction (FiO 2 ) in this protection remains highly uncertain. We aimed to evaluate the effect of intraoperative low (30%) versus high (80%) FiO 2  in the context of lung-protective ventilation strategy on PPCs in patients undergoing abdominal surgery.
DESIGN


Prospective, two-arm, randomized controlled trial.
SETTING


Tertiary university hospital in China.
PATIENTS


A total of ASA I-III 252 patients aged ≥18, who were scheduled for elective abdominal surgery under general anesthesia were included in the study.
INTERVENTION


Patients were randomly assigned to receive either 30% or 80% FiO 2  during the intraoperative period. All patients received volume-controlled mechanical ventilation with lung-protective ventilation approach, which included a tidal volume of 8 ml kg -1  of predicted body weight, a positive end-expiratory pressure level of 6-8 cmH 2 O, and repeated recruitment maneuvers.
MEASUREMENTS


The primary outcome was a composite of postoperative pulmonary complications within the first 7 postoperative days, consisting of respiratory infection, respiratory failure, bronchospasm, atelectasis, pleural effusion, pneumothorax, and aspiration pneumonitis. The severity grade of PPCs was measured as a key secondary outcome.
MAIN RESULTS


Two hundred and fifty-one patients completed the trial. PPCs occurred in 43 of 125 (34.4%) patients assigned to receive 30% FiO 2  compared with 59 of 126 (46.8%) patients receiving 80% FiO 2  (relative risk 0.74, 97.5% confidence interval, 0.51-1.02, p = 0.045, > 0.025). The severity of PPCs within the first 7 days following surgery was attenuated significantly in the low (30%) FiO 2  group (p = 0.001).
CONCLUSIONS


Among patients undergoing abdominal surgery under general anesthesia, an intraoperative lung-protective ventilation strategy with 30% FiO 2  compared with 80% FiO 2  did not reduce the incidence of PPCs. And the use of 30% FiO 2  resulted in less severe pulmonary complications.",2020,"PPCs occurred in 43 of 125 (34.4%) patients assigned to receive 30% FiO 2  compared with 59 of 126 (46.8%) patients receiving 80% FiO 2  (relative risk 0.74, 97.5% confidence interval, 0.51-1.02, p = 0.045, > 0.025).","['patients undergoing abdominal surgery', 'patients undergoing abdominal surgery under general anesthesia', 'Tertiary university hospital in China', 'Two hundred and fifty-one patients completed the trial', 'A total of ASA I-III 252 patients aged ≥18, who were scheduled for elective abdominal surgery under general anesthesia were included in the study', 'postoperative pulmonary complications after abdominal surgery']","['volume-controlled mechanical ventilation with lung-protective ventilation approach', 'low and high inspiratory oxygen fraction added to lung-protective ventilation']","['severe pulmonary complications', 'composite of postoperative pulmonary complications within the first 7 postoperative days, consisting of respiratory infection, respiratory failure, bronchospasm, atelectasis, pleural effusion, pneumothorax, and aspiration pneumonitis', 'PPCs', 'severity of PPCs', 'severity grade of PPCs', 'incidence of PPCs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]","[{'cui': 'C0449972', 'cui_str': 'Volume control'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0035243', 'cui_str': 'Respiratory tract infection'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C0006266', 'cui_str': 'Bronchospasm'}, {'cui': 'C0004144', 'cui_str': 'Atelectasis'}, {'cui': 'C0032227', 'cui_str': 'Pleural effusion'}, {'cui': 'C0032326', 'cui_str': 'Pneumothorax'}, {'cui': 'C0032290', 'cui_str': 'Aspiration pneumonia'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",252.0,0.482006,"PPCs occurred in 43 of 125 (34.4%) patients assigned to receive 30% FiO 2  compared with 59 of 126 (46.8%) patients receiving 80% FiO 2  (relative risk 0.74, 97.5% confidence interval, 0.51-1.02, p = 0.045, > 0.025).","[{'ForeName': 'Xue-Fei', 'Initials': 'XF', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, West China Hospital, Sichuan University & The Research Units of West China (2018RU012), Chinese Academy of Medical Sciences, Chengdu 610041, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Jiang', 'Affiliation': 'Department of Anesthesiology, West China Hospital, Sichuan University & The Research Units of West China (2018RU012), Chinese Academy of Medical Sciences, Chengdu 610041, China.'}, {'ForeName': 'Yu-Lian', 'Initials': 'YL', 'LastName': 'Jiang', 'Affiliation': 'Department of Anesthesiology, West China Hospital, Sichuan University & The Research Units of West China (2018RU012), Chinese Academy of Medical Sciences, Chengdu 610041, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Yu', 'Affiliation': 'Department of Anesthesiology, West China Hospital, Sichuan University & The Research Units of West China (2018RU012), Chinese Academy of Medical Sciences, Chengdu 610041, China.'}, {'ForeName': 'Meng-Qiu', 'Initials': 'MQ', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, West China Hospital, Sichuan University & The Research Units of West China (2018RU012), Chinese Academy of Medical Sciences, Chengdu 610041, China.'}, {'ForeName': 'Jia-Li', 'Initials': 'JL', 'LastName': 'Jiang', 'Affiliation': 'Department of Anesthesiology, West China Hospital, Sichuan University & The Research Units of West China (2018RU012), Chinese Academy of Medical Sciences, Chengdu 610041, China.'}, {'ForeName': 'Lei-Lei', 'Initials': 'LL', 'LastName': 'He', 'Affiliation': 'Department of Anesthesiology, West China Hospital, Sichuan University & The Research Units of West China (2018RU012), Chinese Academy of Medical Sciences, Chengdu 610041, China.'}, {'ForeName': 'Hai', 'Initials': 'H', 'LastName': 'Yu', 'Affiliation': 'Department of Anesthesiology, West China Hospital, Sichuan University & The Research Units of West China (2018RU012), Chinese Academy of Medical Sciences, Chengdu 610041, China. Electronic address: yuhaishan117@yahoo.com.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.110009']
2524,32841543,"Comparison between the effects of elective nodal irradiation and involved-field irradiation on long-term survival in thoracic esophageal squamous cell carcinoma patients: A prospective, multicenter, randomized, controlled study in China.","BACKGROUND


This study's initial results revealed significant decreases in treatment-related esophagitis and pneumonitis cases in patients with thoracic esophageal squamous cell carcinoma (ESCC) treated with involved-field irradiation (IFI), compared to elective nodal irradiation (ENI). This report outlines the long-term trial results, specifically; overall survival (OS), progression-free survival (PFS), metastasis-free survival (MFS), and locoregional progression-free survival (LRFS).
MATERIALS AND METHODS


Stage II-III thoracic ESCC patients were assigned randomly, in a 1:1 ratio, into either the ENI or IFI arm. Radiation therapy was delivered once a day in 1.8-2.0 Gy fractions to a total dose of 60.0-66.0 Gy to the gross tumor volume and 50.0-54.0 Gy to the clinical target volume. The primary endpoints were acute treatment-related esophagitis and pneumonitis. The results for the primary endpoints were previously published in 2018. In this article, we analyzed the secondary endpoints including PFS, LRFS, MFS, and OS.
RESULTS


Between April 2012 and October 2016, 228 patients from nine participating centers in China were enrolled into this study and randomly assigned to two treatment groups. For ENI and IFI groups, respectively, the results showed similarity and were as follows: median PFS (20.3 months vs 21.4 months), OS (32.5 months vs 34.9 months), MFS (28.2 months vs 26.0 months), and LRFS (25.0 months vs 26.6 months). In particular, respective OS rates in the ENI and IFI groups were 84.6% and 82.5% after 1 year, 45.1% and 48.7% after 3 years, and 29.8% and 30.7% at 5 years. PFS rates after 1, 3, and 5 years were 58.9%, 34.2%, and 26.9%, respectively, in the ENI arm compared to 64.4%, 30.8%, and 27.7%, respectively, in the IFI arm. Multivariate analysis identified clinical stage and tumor responses as independent predictors of OS. Meanwhile, tumor location, cStage, and tumor response were identified as independent factors influencing PFS.
CONCLUSION


IFI was associated with similar survival as ENI in patients with thoracic ESCC, suggesting that IFI is an acceptable treatment method for thoracic ESCC.",2020,"PFS rates after 1, 3, and 5 years were 58.9%, 34.2%, and 26.9%, respectively, in the ENI arm compared to 64.4%, 30.8%, and 27.7%, respectively, in the IFI arm.","['patients with thoracic esophageal squamous cell carcinoma (ESCC', 'thoracic ESCC patients', 'Stage II-III', '228 patients from nine participating centers in China', 'Between April 2012 and October 2016', 'thoracic esophageal squamous cell carcinoma patients', 'patients with thoracic ESCC']","['elective nodal irradiation (ENI', 'Radiation therapy', 'elective nodal irradiation and involved-field irradiation']","['PFS rates', 'acute treatment-related esophagitis and pneumonitis', 'respective OS rates', 'PFS, LRFS, MFS, and OS', 'overall survival (OS), progression-free survival (PFS), metastasis-free survival (MFS), and locoregional progression-free survival (LRFS', 'LRFS', 'MFS', 'Meanwhile, tumor location, cStage, and tumor response', 'OS', 'median PFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0279626', 'cui_str': 'Squamous cell carcinoma of esophagus'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0443268', 'cui_str': 'Nodal'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0014868', 'cui_str': 'Esophagitis'}, {'cui': 'C3714636', 'cui_str': 'Pneumonitis'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",,0.0547264,"PFS rates after 1, 3, and 5 years were 58.9%, 34.2%, and 26.9%, respectively, in the ENI arm compared to 64.4%, 30.8%, and 27.7%, respectively, in the IFI arm.","[{'ForeName': 'Jiahua', 'Initials': 'J', 'LastName': 'Lyu', 'Affiliation': 'School of Medicine, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Abulimiti', 'Initials': 'A', 'LastName': 'Yisikandaer', 'Affiliation': 'The Affiliated Tumor Hospital of Xinjiang Medical University, Xinjiang, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'School of Medicine, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Xiaozhi', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ""The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Xiaohu', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Gansu Cancer Hospital, Lanzhou, China.'}, {'ForeName': 'Zhongge', 'Initials': 'Z', 'LastName': 'Tian', 'Affiliation': 'Wu Wei Tumor Hospital, Wu Wei, China.'}, {'ForeName': 'Long', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'The Affiliated Cancer Hospital of Guangxi Medical University, Guangxi, China.'}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Lu', 'Affiliation': 'Guizhou Cancer Hospital, Guiyang, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Kunming General Hospital of Chengdu Military Region, Kunming, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Xinjiang Renmin Hospital, Xinjiang, China.'}, {'ForeName': 'Qifeng', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Sichuan Cancer Hospital Institute, Sichuan Cancer Center, School of Medicine, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Jinnrong', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'The Affiliated Tumor Hospital of Xinjiang Medical University, Xinjiang, China.'}, {'ForeName': 'Youguo', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': 'Wu Wei Tumor Hospital, Wu Wei, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Liu', 'Affiliation': ""The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Ruifeng', 'Initials': 'R', 'LastName': 'Liu', 'Affiliation': 'Gansu Cancer Hospital, Lanzhou, China.'}, {'ForeName': 'Aiguri', 'Initials': 'A', 'LastName': 'Hage', 'Affiliation': 'The Affiliated Tumor Hospital of Xinjiang Medical University, Xinjiang, China.'}, {'ForeName': 'Jinyi', 'Initials': 'J', 'LastName': 'Lang', 'Affiliation': 'Sichuan Cancer Hospital Institute, Sichuan Cancer Center, School of Medicine, University of Electronic Science and Technology of China, Chengdu, China.'}]",Cancer medicine,['10.1002/cam4.3409']
2525,32841683,"Oral administration of porcine liver decomposition product for 4 weeks enhances visual memory and delayed recall in healthy adults over 40 years of age: A randomized, double-blind, placebo-controlled study.","BACKGROUND AND OBJECTIVES


Porcine liver decomposition product (PLDP) contains neurofunctional phospholipids. We previously reported that PLDP enhances cognitive function in healthy adult humans, based on clinical evaluations using Hasegawa's Dementia Scale-Revised. In this study, we evaluated the effect of PLDP on memory indicators of the Wechsler Memory Scale-Revised (WMS-R), an internationally recognized battery for memory assessment.
METHODS


We conducted a double-blind parallel-group placebo-controlled trial to evaluate the effect of PLDP on memory. Fifty-eight participants competed the trial: 28 participants were in the PLDP group and 30 participants were in the placebo group. Each group was administered PLDP (4 capsules) or a placebo (4 capsules) for 4 continuous weeks. WMS-R was administered before and 4 weeks after PLDP or placebo intake. The data were also subdivided by age for participants under 40 years (N = 15 in PLDP; N = 15 in placebo) and over 40 years (N = 13 in PLDP, N = 15 in placebo). Changes in Verbal Memory, Visual Memory, Attention/Concentration, and Delayed Recall were analyzed.
RESULTS


No significant differences were found in any memory indicators between the PLDP group and the placebo group in pooled participants and in participants under 40 years of age. However, for participants over 40 years of age, PLDP administration resulted in a significant enhancement than placebo administration in Delayed Recall (14.1 ± 7.1 points vs. 7.1 ± 6.8 points) (P < 0.05), Visual Recall I (20.1 ± 23.1 percentile vs 1.9 ± 22.8 percentile) (P < 0.05), and Visual Recall II (24.2 ± 25.8 percentile vs 6.7 ± 19.0 percentile) (P < 0.05), respectively. The composition ratio of men to women in each group was imbalanced but no significant difference existed between the two groups.
LIMITATIONS


A modest sample size, single-center design, and a fairly short follow-up period.
CONCLUSION


PLDP enhanced Visual Memory and Delayed Recall in healthy adults over 40 years of age but not in healthy adults under 40 years of age. Therefore, PLDP may represent a promising nutraceutical that could improve cognitive function in healthy adults over 40 years of age. Further studies are required to evaluate if long term PLDP administration can prevent or delay cognitive dysfunction in healthy adults over 40 years of age.",2020,No significant differences were found in any memory indicators between the PLDP group and the placebo group in pooled participants and in participants under 40 years of age.,"['Fifty-eight participants competed the trial: 28 participants were in the PLDP group and 30 participants were in the', 'healthy adults over 40\u202fyears of age', 'healthy adult humans', 'participants under 40\u202fyears (N\u202f=\u202f15 in PLDP; N\u202f=\u202f15 in placebo) and over 40\u202fyears (N\u202f=\u202f13 in PLDP, N\u202f=\u202f15 in', 'healthy adults over 40\u202fyears of age but not in healthy adults under 40\u202fyears of age']","['PLDP', 'placebo', 'porcine liver decomposition product']","['Verbal Memory, Visual Memory, Attention/Concentration, and Delayed Recall', 'Visual Recall I', 'Visual Memory and Delayed Recall', 'cognitive function', 'memory indicators of the Wechsler Memory Scale-Revised (WMS-R', 'visual memory and delayed recall', 'composition ratio', 'Visual Recall', 'memory indicators', 'Delayed Recall']","[{'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0039005', 'cui_str': 'Suidae'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0039005', 'cui_str': 'Suidae'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C0542316', 'cui_str': 'Visual memory'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0451575', 'cui_str': 'Wechsler memory scale'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",28.0,0.574256,No significant differences were found in any memory indicators between the PLDP group and the placebo group in pooled participants and in participants under 40 years of age.,"[{'ForeName': 'Yoshikazu', 'Initials': 'Y', 'LastName': 'Matsuda', 'Affiliation': 'Division of Clinical Pharmacology and Pharmaceutics, Nihon Pharmaceutical University, Ina 362-0806, Japan. Electronic address: yomatsuda@nichiyaku.ac.jp.'}, {'ForeName': 'Hisao', 'Initials': 'H', 'LastName': 'Haniu', 'Affiliation': 'Institute for Biomedical Sciences, Interdisciplinary Cluster for Cutting Edge Research, Shinshu University, Matsumoto 390-8621, Japan.'}, {'ForeName': 'Tamotsu', 'Initials': 'T', 'LastName': 'Tsukahara', 'Affiliation': 'Department of Pharmacology and Therapeutic Innovation, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki 852-8521, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Uemura', 'Affiliation': 'Institute for Biomedical Sciences, Interdisciplinary Cluster for Cutting Edge Research, Shinshu University, Matsumoto 390-8621, Japan; Division of Gene Research, Research Center for Supports to Advanced Science, Shinshu University, Matsumoto 390-8621, Japan.'}, {'ForeName': 'Toshio', 'Initials': 'T', 'LastName': 'Inoue', 'Affiliation': 'Division of Clinical Pharmacology and Pharmaceutics, Nihon Pharmaceutical University, Ina 362-0806, Japan.'}, {'ForeName': 'Ken-Ichi', 'Initials': 'KI', 'LastName': 'Sako', 'Affiliation': 'Division of Clinical Pharmacology and Pharmaceutics, Nihon Pharmaceutical University, Ina 362-0806, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Kojima', 'Affiliation': 'Medical and Health Resources Research Institute, Tokyo 170-0013, Japan.'}, {'ForeName': 'Tatsuro', 'Initials': 'T', 'LastName': 'Mori', 'Affiliation': 'Mori Neurosurgery Clinic, Tokyo 142-0053, Japan.'}, {'ForeName': 'Kazusaburou', 'Initials': 'K', 'LastName': 'Sato', 'Affiliation': 'Sugar Lady Cosmetics Co., Ltd, Tokyo 107-6011, Japan.'}]",Experimental gerontology,['10.1016/j.exger.2020.111064']
2526,32843703,Naltrexone modulates contextual processing in depression.,"Context, the information surrounding an experience, can significantly alter the meaning and the affective responses to events. Yet the biological mechanisms through which context modulate experiences are not entirely understood. Here, we hypothesized that the µ-opioid system-extensively implicated in placebo effects, a clinical phenomenon thought to rely on contextual processing-modulates the effects of contextual information on emotional attributions in patients with depression. To test this hypothesis, 20 unmedicated patients with depression completed a randomized, double-blind, placebo-controlled, crossover study of one dose of 50 mg of naltrexone, or placebo immediately before completing two sessions of the Contextual Framing fMRI task. This task captures effects of valenced contextual cues (pleasant vs. unpleasant) on emotional attribution (the rating of subtle emotional faces: fearful, neutral, or happy). Behaviorally, we found that emotional attribution was significantly moderated by the interaction between contextual cues and subtle emotional faces, such that participants' ratings of valenced faces (fearful and happy), compared to neutral, were more negative during unpleasant, compared to pleasant context cues. At a neural level, context-induced blood-oxygen-level-dependent responses in the ventromedial prefrontal cortex, the dorsal anterior cingulate, the dorsolateral prefrontal cortex, and the lateral orbitofrontal cortex, significantly moderated the effects of context on emotional attribution, and were blunted by naltrexone. Furthermore, the effects of naltrexone on emotional attribution were partially abolished in more severely depressed patients. Our results provide insights into the molecular alterations underlying context representation in patients with depression, providing pivotal early data for future treatment studies.",2020,"At a neural level, context-induced blood-oxygen-level-dependent responses in the ventromedial prefrontal cortex, the dorsal anterior cingulate, the dorsolateral prefrontal cortex, and the lateral orbitofrontal cortex, significantly moderated the effects of context on emotional attribution, and were blunted by naltrexone.","['patients with depression', '20 unmedicated patients with depression', 'depression']","['placebo', 'Naltrexone', 'naltrexone, or placebo', 'naltrexone', 'valenced contextual cues (pleasant vs. unpleasant']","[""contextual cues and subtle emotional faces, such that participants' ratings of valenced faces (fearful and happy"", 'emotional attribution']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C0010439', 'cui_str': 'Cues'}]","[{'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}]",20.0,0.0755192,"At a neural level, context-induced blood-oxygen-level-dependent responses in the ventromedial prefrontal cortex, the dorsal anterior cingulate, the dorsolateral prefrontal cortex, and the lateral orbitofrontal cortex, significantly moderated the effects of context on emotional attribution, and were blunted by naltrexone.","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Mizuno', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Lyew', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'H T', 'Initials': 'HT', 'LastName': 'Karim', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'J F', 'Initials': 'JF', 'LastName': 'Karp', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'A Y', 'Initials': 'AY', 'LastName': 'Dombrovski', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Peciña', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, PA, USA. pecinam@upmc.edu.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-00809-2']
2527,32851418,Reply to Letter to Editor: Safety of one-stage bilateral total knee arthroplasty-one-surgeon sequential vs. two surgeons simultaneous: a randomized controlled study.,,2020,,[],['one-stage bilateral total knee arthroplasty-one-surgeon sequential vs. two surgeons simultaneous'],[],[],"[{'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}]",[],,0.070912,,"[{'ForeName': 'Gökçer', 'Initials': 'G', 'LastName': 'Uzer', 'Affiliation': 'Department of Orthopaedics and Traumatology, Bezmialem Vakıf University, Istanbul, Turkey.'}, {'ForeName': 'Orkhan', 'Initials': 'O', 'LastName': 'Aliyev', 'Affiliation': 'Department of Orthopaedics and Traumatology, Bezmialem Vakıf University, Istanbul, Turkey.'}, {'ForeName': 'Fatih', 'Initials': 'F', 'LastName': 'Yıldız', 'Affiliation': 'Department of Orthopaedics and Traumatology, Bezmialem Vakıf University, Istanbul, Turkey. yildizfatih@hotmail.com.'}, {'ForeName': 'Nurdan', 'Initials': 'N', 'LastName': 'Güngören', 'Affiliation': 'Department of Orthopaedics and Traumatology, Bezmialem Vakıf University, Istanbul, Turkey.'}, {'ForeName': 'Nurzat', 'Initials': 'N', 'LastName': 'Elmalı', 'Affiliation': 'Department of Orthopaedics and Traumatology, Bezmialem Vakıf University, Istanbul, Turkey.'}, {'ForeName': 'İbrahim', 'Initials': 'İ', 'LastName': 'Tuncay', 'Affiliation': 'Department of Orthopaedics and Traumatology, Bezmialem Vakıf University, Istanbul, Turkey.'}]",International orthopaedics,['10.1007/s00264-020-04783-8']
2528,32846929,A Traditional Korean Diet Alters the Expression of Circulating MicroRNAs Linked to Diabetes Mellitus in a Pilot Trial.,"The traditional Korean diet (K-diet) is considered to be healthy and circulating microRNAs (miRs) have been proposed as useful markers or targets in diet therapy. We, therefore, investigated the metabolic influence of the K-diet by evaluating the expression of plasma and salivary miRs. Ten women aged 50 to 60 years were divided into either a K-diet or control diet (a Westernized Korean diet) group. Subjects were housed in a metabolic unit-like condition during the two-week dietary intervention. Blood and saliva samples were collected before and after the intervention, and changes in circulating miRs were screened by an miR array and validated by individual RT-qPCRs. In the K-diet group, eight plasma miRs were down-regulated by array ( p  < 0.05), out of which two miRs linked to diabetes mellitus, hsa-miR26a-5p and hsa-miR126-3p, were validated ( p  < 0.05). Among five down-regulated salivary miRs, hsa-miR-92-3p and hsa-miR-122a-5p were validated, which are associated with diabetes mellitus, acute coronary syndrome and non-alcoholic fatty liver disease. In the control diet group, validated were down-regulated plasma hsa-miR-25-3p and salivary hsa-miR-31-5p, which are associated with diabetes mellitus, adipogenesis and obesity. The K-diet may influence the metabolic conditions associated with diabetes mellitus, as evidenced by changes in circulating miRs, putative biomarkers for K-diet.",2020,"In the K-diet group, eight plasma miRs were down-regulated by array ( p  < 0.05), out of which two miRs linked to diabetes mellitus, hsa-miR26a-5p and hsa-miR126-3p, were validated ( p  < 0.05).",['Ten women aged 50 to 60 years'],"['K-diet or control diet (a Westernized Korean diet', 'traditional Korean diet (K-diet']","['Blood and saliva samples', 'eight plasma miRs', 'Expression of Circulating MicroRNAs']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0743195', 'cui_str': 'Dietary control'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C1101610', 'cui_str': 'MicroRNA'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C4055233', 'cui_str': 'Cell-Free MicroRNA'}]",10.0,0.0120408,"In the K-diet group, eight plasma miRs were down-regulated by array ( p  < 0.05), out of which two miRs linked to diabetes mellitus, hsa-miR26a-5p and hsa-miR126-3p, were validated ( p  < 0.05).","[{'ForeName': 'Phil-Kyung', 'Initials': 'PK', 'LastName': 'Shin', 'Affiliation': 'CHA Bio Complex, CHA University, Seongnam 13488, Korea.'}, {'ForeName': 'Myung Sunny', 'Initials': 'MS', 'LastName': 'Kim', 'Affiliation': 'Research Group of Healthcare, Korea Food Research Institute, Wanju 55365, Korea.'}, {'ForeName': 'Seon-Joo', 'Initials': 'SJ', 'LastName': 'Park', 'Affiliation': 'Department of Food and Nutrition, College of BioNano Technology, Gachon University, Seongnam 13120, Korea.'}, {'ForeName': 'Dae Young', 'Initials': 'DY', 'LastName': 'Kwon', 'Affiliation': 'Research Group of Healthcare, Korea Food Research Institute, Wanju 55365, Korea.'}, {'ForeName': 'Min Jung', 'Initials': 'MJ', 'LastName': 'Kim', 'Affiliation': 'Research Group of Healthcare, Korea Food Research Institute, Wanju 55365, Korea.'}, {'ForeName': 'Hye Jeong', 'Initials': 'HJ', 'LastName': 'Yang', 'Affiliation': 'Research Group of Healthcare, Korea Food Research Institute, Wanju 55365, Korea.'}, {'ForeName': 'Soon-Hee', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'Research Group of Healthcare, Korea Food Research Institute, Wanju 55365, Korea.'}, {'ForeName': 'KyongChol', 'Initials': 'K', 'LastName': 'Kim', 'Affiliation': 'Department of Healthy Aging, GangNam Major Hospital, Seoul 06279, Korea.'}, {'ForeName': 'Sukyung', 'Initials': 'S', 'LastName': 'Chun', 'Affiliation': 'CHA Bio Complex, CHA University, Seongnam 13488, Korea.'}, {'ForeName': 'Hae-Jeung', 'Initials': 'HJ', 'LastName': 'Lee', 'Affiliation': 'Department of Food and Nutrition, College of BioNano Technology, Gachon University, Seongnam 13120, Korea.'}, {'ForeName': 'Sang-Woon', 'Initials': 'SW', 'LastName': 'Choi', 'Affiliation': 'CHA Bio Complex, CHA University, Seongnam 13488, Korea.'}]",Nutrients,['10.3390/nu12092558']
2529,32857128,"Long-term Effects of Calcium β-Hydroxy-β-Methylbutyrate and Vitamin D3 Supplementation on Muscular Function in Older Adults With and Without Resistance Training: A Randomized, Double-blind, Controlled Study.","The primary aim of this study was to determine whether supplementation with calcium β-hydroxy-β-methylbutyrate (HMB) and vitamin D3 (D) would enhance muscle function and strength in older adults. Older adults over 60 years of age with insufficient circulating 25-hydroxy-vitamin D (25OH-D) levels were enrolled in a double-blinded controlled 12-month study. Study participants were randomly assigned to treatments consisting of: (a) Control + no exercise, (b) HMB+D + no exercise, (c) Control + exercise, and (d) HMB+D + exercise. The study evaluated 117 participants via multiple measurements over the 12 months that included body composition, strength, functionality, and questionnaires. HMB+D had a significant benefit on lean body mass within the nonexercise group at 6 months (0.44 ± 0.27 kg, HMB+D vs -0.33 ± 0.28 kg, control, p < .05). In nonexercisers, improvement in knee extension peak torque (60°/s) was significantly greater in HMB+D-supplemented participants than in the nonsupplemented group (p = .04) at 3 months, 10.9 ± 5.7 Nm and -5.2 ± 5.9 Nm, respectively. A composite functional index, integrating changes in handgrip, Get Up, and Get Up and Go measurements, was developed. HMB+D + no exercise resulted in significant increases in the functional index compared with those observed in the control + no exercise group at 3 (p = .03), 6 (p = .04), and 12 months (p = .04). Supplementation with HMB+D did not further improve the functional index within the exercising group. This study demonstrated the potential of HMB and vitamin D3 supplementation to enhance muscle strength and physical functionality in older adults, even in individuals not engaged in an exercise training program.",2020,"In non-exercisers, improvement in knee extension peak torque (60°/sec) was significantly greater in HMB+D supplemented participants than in non-supplemented group (p=0.04) at 3 months, 10.9 ± 5.7Nm and -5.2 ± 5.9Nm, respectively.","['older adults', 'Older Adults with and without Resistance Training', 'Older adults over 60 years of age with insufficient circulating 25-hydroxy-Vitamin D (25OH-D) levels', 'older adults, even in individuals not engaged in an exercise training program', '117 participants consisting of multiple measurements over the 12 months that included body composition, strength, functionality, and questionnaires']","['Calcium β-Hydroxy-β-methylbutyrate (HMB) and Vitamin D3 Supplementation', 'Control + no exercise; (b) HMB+D + no exercise; (c) Control + exercise, and (d) HMB+D + exercise', 'HMB and Vitamin D3 supplementation', 'calcium β-hydroxy-β-methylbutyrate (HMB) and Vitamin D3 (D', 'HMB+D + no exercise', 'HMB+D']","['Muscular Function', 'muscle strength and physical functionality', 'lean body mass', 'functional index', 'knee extension peak torque']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]","[{'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}]",117.0,0.119148,"In non-exercisers, improvement in knee extension peak torque (60°/sec) was significantly greater in HMB+D supplemented participants than in non-supplemented group (p=0.04) at 3 months, 10.9 ± 5.7Nm and -5.2 ± 5.9Nm, respectively.","[{'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Rathmacher', 'Affiliation': 'MTI BioTech, Inc., Iowa State University Research Park, Ames.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Pitchford', 'Affiliation': 'MTI BioTech, Inc., Iowa State University Research Park, Ames.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Khoo', 'Affiliation': 'Department of Kinesiology, Iowa State University, Ames.'}, {'ForeName': 'Hector', 'Initials': 'H', 'LastName': 'Angus', 'Affiliation': 'Department of Kinesiology, Iowa State University, Ames.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Lang', 'Affiliation': 'Department of Kinesiology, Iowa State University, Ames.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Lowry', 'Affiliation': 'Department of Physical Therapy, Des Moines University.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Ruby', 'Affiliation': 'Department of Physical Therapy, Des Moines University.'}, {'ForeName': 'Alex C', 'Initials': 'AC', 'LastName': 'Krajek', 'Affiliation': 'Department of Physical Therapy, Des Moines University.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Fuller', 'Affiliation': 'Metabolic Technologies, LLC, Missoula, MT.'}, {'ForeName': 'Rick L', 'Initials': 'RL', 'LastName': 'Sharp', 'Affiliation': 'Department of Kinesiology, Iowa State University, Ames.'}]","The journals of gerontology. Series A, Biological sciences and medical sciences",['10.1093/gerona/glaa218']
2530,32858227,"The impact of Geriatric Emergency Department Innovations (GEDI) on health services use, health related quality of life, and costs: Protocol for a randomized controlled trial.","BACKGROUND AND OBJECTIVES


Older adults (age 65 and older) use the emergency department (ED) at a rate of nearly 50 ED visits per 100 older adults, accounting for over 23 million ED visits in the US annually, up to 20% of all ED visits. These ED visits are sentinel health events as discharged patients often return to the ED, experience declines in health-related quality of life (HRQoL) and disability, or are later hospitalized. Those who are admitted incur increased costs and greater risk for poor outcomes including infections, delirium, and falls. The objective of this randomized controlled trial (RCT) is to evaluate the efficacy of the Geriatric Emergency Department Innovations (GEDI) program, an ED nurse-led geriatric assessment and care coordination program, in decreasing unnecessary health services use and improving Health-Related Quality-of-Life (HRQoL) for older adults in the ED.
METHODS


Community dwelling older adults aged 65 and older who are vulnerable or frail according to the Clinical Frailty Scale (CFS) during an ED visit will be randomized to either GEDI (n = 420) or to usual ED care (n = 420). Outcome variables will be assessed during the ED visit and at 7-11 days and 28-32 days post ED visit.
PROJECTED OUTCOMES


The primary outcome is hospitalization or death within 30 days of the ED visit. Secondary outcomes include health service use outcomes (ED visits and hospitalizations), healthcare costs, and HRQoL outcomes [Patient-Reported Outcomes Measurement Information System (PROMIS) scores: PROMIS-Preference, Physical Function, Ability to Participate in Social Roles and Activities, Anxiety, and Depression].
TRIAL REGISTRATION


Clinicaltrials.Gov identifier NCT04115371.",2020,"METHODS


Community dwelling older adults aged 65 and older who are vulnerable or frail according to the Clinical Frailty Scale (CFS) during an ED visit will be randomized to either GEDI (n = 420) or to usual ED care (n = 420).","['Community dwelling older adults aged 65 and older who are vulnerable or frail according to the Clinical Frailty Scale (CFS) during an ED visit will be randomized to either', 'older adults in the ED', 'Older adults (age 65 and older) use the emergency department (ED) at a rate of nearly 50 ED visits per 100 older adults, accounting for over 23 million ED visits in the US annually, up to 20% of all ED visits']","['Geriatric Emergency Department Innovations (GEDI', 'GEDI (n\u202f=\u202f420) or to usual ED care']","['health service use outcomes (ED visits and hospitalizations), healthcare costs, and HRQoL outcomes [Patient-Reported Outcomes Measurement Information System (PROMIS) scores: PROMIS-Preference, Physical Function, Ability to Participate in Social Roles and Activities, Anxiety, and Depression', 'hospitalization or death within 30\u202fdays of the ED visit', 'infections, delirium, and falls', 'Health-Related Quality-of-Life (HRQoL']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C1881839', 'cui_str': '1000000'}, {'cui': 'C0547043', 'cui_str': 'Up'}]","[{'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C4517774', 'cui_str': '420'}]","[{'cui': 'C0018747', 'cui_str': 'Services, Health'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0021428', 'cui_str': 'Information system'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}]",,0.106207,"METHODS


Community dwelling older adults aged 65 and older who are vulnerable or frail according to the Clinical Frailty Scale (CFS) during an ED visit will be randomized to either GEDI (n = 420) or to usual ED care (n = 420).","[{'ForeName': 'Scott M', 'Initials': 'SM', 'LastName': 'Dresden', 'Affiliation': 'Department of Emergency Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA; Center for Health Services and Outcomes Research, Institute for Public Health and Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA; Buheler Center for Health Policy and Economics, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA. Electronic address: sdresden@nm.org.'}, {'ForeName': 'Alexander X', 'Initials': 'AX', 'LastName': 'Lo', 'Affiliation': 'Department of Emergency Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA; Center for Health Services and Outcomes Research, Institute for Public Health and Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Lee A', 'Initials': 'LA', 'LastName': 'Lindquist', 'Affiliation': 'Department of Internal Medicine, Division of General Internal Medicine and Geriatrics, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Masha', 'Initials': 'M', 'LastName': 'Kocherginsky', 'Affiliation': 'Department of Preventive Medicine, Division of Biostatistics, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Lori Ann', 'Initials': 'LA', 'LastName': 'Post', 'Affiliation': 'Department of Emergency Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA; Buheler Center for Health Policy and Economics, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Dustin D', 'Initials': 'DD', 'LastName': 'French', 'Affiliation': 'Center for Health Services and Outcomes Research, Institute for Public Health and Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA; Department of Ophthalmology, Feinberg School of Medicine, Northwestern University, USA; Department of Veterans Affairs Health Services Research and Development Service, Edward Hines, Jr. VA Hospital, Hines, IL, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Gray', 'Affiliation': 'Department of Preventive Medicine, Division of Biostatistics, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Allen W', 'Initials': 'AW', 'LastName': 'Heinemann', 'Affiliation': 'Department of Emergency Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA; Center for Health Services and Outcomes Research, Institute for Public Health and Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA; Department of Physical Medicine and Rehabilitation, Feinberg School of Medicine, Northwestern University and Center for Rehabilitation Outcomes Research, Shirley Ryan AbilityLab, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106125']
2531,32858333,Experimental sleep restriction increases somatic complaints in healthy adolescents.,"Short duration sleep and somatic complaints (bodily complaints like aches/pains or GI distress) are common in adolescence and may be linked, yet no published studies have tested causation. In this study, healthy adolescents (n = 30; 14-18yrs) completed a three-week, within-subject cross-over experiment. Following a sleep stabilization week, adolescents were randomized (in counterbalanced order) to five nights of 6.5hrs in bed (Insufficient Sleep) or 9.5hrs in bed (Sufficient Sleep), each preceded by a two-night ""washout."" Somatic complaints were assessed via the Children's Somatic Symptoms Inventory (CSSI-24) and the Pain and Symptom Assessment Tool (PSAT) concluding each condition. Adherence to experimental condition was confirmed via actigraphy. Adolescents slept two fewer hours and reported significantly greater frequency and severity of somatic complaints during the Insufficient Sleep (vs. Sufficient Sleep) condition. Restricting sleep opportunity to a level common in adolescence causally increased somatic complaints in otherwise healthy adolescents. Findings support clinical and preventative efforts to address pervasively inadequate sleep in adolescence.",2020,"Short duration sleep and somatic complaints (bodily complaints like aches/pains or GI distress) are common in adolescence and may be linked, yet no published studies have tested causation.","['otherwise healthy adolescents', 'healthy adolescents', 'healthy adolescents (n\xa0=\xa030; 14-18yrs']","['Experimental sleep restriction', 'five nights of 6.5hrs in bed (Insufficient Sleep) or 9.5hrs in bed (Sufficient Sleep), each preceded by a two-night ""washout']","[""Children's Somatic Symptoms Inventory (CSSI-24) and the Pain and Symptom Assessment Tool (PSAT"", 'Somatic complaints', 'frequency and severity of somatic complaints']","[{'cui': 'C0686747', 'cui_str': 'Well adolescent'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0332152', 'cui_str': 'Before'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C3839861', 'cui_str': 'Medically unexplained symptom'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3494437', 'cui_str': 'Symptom Assessment'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C1257909', 'cui_str': 'Diploid Cell'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",,0.0189992,"Short duration sleep and somatic complaints (bodily complaints like aches/pains or GI distress) are common in adolescence and may be linked, yet no published studies have tested causation.","[{'ForeName': 'Kendra N', 'Initials': 'KN', 'LastName': 'Krietsch', 'Affiliation': ""Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, 3333 Burnet Ave, Cincinnati, OH, 45229-3026, USA. Electronic address: kendrakrietsch@gmail.com.""}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'King', 'Affiliation': ""Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, 3333 Burnet Ave, Cincinnati, OH, 45229-3026, USA; Center for Understanding Pediatric Pain (CUPP), Cincinnati Children's Hospital Medical Center, 3333 Burnet Ave, Cincinnati, OH, 45229-3026, USA; Department of Pediatrics, University of Cincinnati College of Medicine, USA. Electronic address: Christopher.king@cchmc.org.""}, {'ForeName': 'Dean W', 'Initials': 'DW', 'LastName': 'Beebe', 'Affiliation': ""Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, 3333 Burnet Ave, Cincinnati, OH, 45229-3026, USA; Department of Pediatrics, University of Cincinnati College of Medicine, USA. Electronic address: Dean.beebe@cchmc.org.""}]",Sleep medicine,['10.1016/j.sleep.2020.07.020']
2532,32858393,Reducing fall risk for home care workers with slip resistant winter footwear.,"Falls on icy surfaces are the leading cause of occupational injuries for workers exposed to outdoor winter conditions. Slip resistant footwear has been shown to reduce the risk of falls for indoor workers but until recently, there was no accepted standard for evaluating the slip resistance of winter footwear on icy surfaces. Our team recently developed a lab-based testing protocol for measuring footwear slip resistance. This protocol, called the Maximum Achievable Angle (MAA) test, measures the steepest ice-covered slope that participants can walk up and down without experiencing a slip in a simulated winter environment. This lab-based protocol has found there is wide variability in the performance of commercially available winter footwear. In particular, we have found that a new generation of footwear that incorporates composite materials in the outsole, performs much better than most other footwear. The objective of this project was to investigate whether the footwear that performed well in our lab-based testing would reduce the risk of slips and/or falls in real-world winter conditions. One hundred and ten home healthcare workers from SE Health were recruited for this study and were asked to report their exposure to icy surfaces along with the numbers of slips and numbers of falls they experienced each week using online surveys over eight weeks in the winter. Fifty participants (the intervention group) were provided winter footwear that were among the best performing in the MAA test. The remaining sixty participants (the control group) wore their own footwear for the duration of the study. A total of 563 slips and 36 falls were reported over the eight-week data collection period. The intervention group consistently reported fewer slips (127 vs 436) and fewer falls (6 vs 30) compared to the control group. We found the slip rate in the intervention group was between 68.0% and 68.7% lower than the control group. Similarly, the fall rate was between 78.5% and 81.5% lower in the intervention group compared to the control group. These findings demonstrate that footwear that performs well in the MAA test can reduce the risk of both slips and falls in real-world winter conditions.",2020,The intervention group consistently reported fewer slips (127 vs 436) and fewer falls (6 vs 30) compared to the control group.,"['Fifty participants (the intervention group) were provided winter footwear that were among the best performing in the MAA test', 'One hundred and ten home healthcare workers from SE Health', 'home care workers with slip resistant winter footwear']",[],"['fall rate', 'slip rate']","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0336894', 'cui_str': 'Footwear'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0204977', 'cui_str': 'Home care of patient'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0337209', 'cui_str': 'Slipping'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}]",[],"[{'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0337209', 'cui_str': 'Slipping'}]",563.0,0.0200659,The intervention group consistently reported fewer slips (127 vs 436) and fewer falls (6 vs 30) compared to the control group.,"[{'ForeName': 'Z Shaghayegh', 'Initials': 'ZS', 'LastName': 'Bagheri', 'Affiliation': 'Department of Mechanical Engineering, George Mason University, 4400 University Dr, Fairfax, VA, 22030, USA; Kite Research Institute, Toronto Rehabilitation Institute, University Health Network, 550 University Ave, Toronto, M5G2A2, Canada. Electronic address: sbagheri@gmu.edu.'}, {'ForeName': 'Jose Diaz', 'Initials': 'JD', 'LastName': 'Beltran', 'Affiliation': 'Kite Research Institute, Toronto Rehabilitation Institute, University Health Network, 550 University Ave, Toronto, M5G2A2, Canada.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Holyoke', 'Affiliation': 'Saint Elizabeth Health Care, 90 Allstate Parkway, Suite 300, Markham, Ontario, L3R 5H3, Canada.'}, {'ForeName': 'Tilak', 'Initials': 'T', 'LastName': 'Dutta', 'Affiliation': 'Kite Research Institute, Toronto Rehabilitation Institute, University Health Network, 550 University Ave, Toronto, M5G2A2, Canada; Institute of Biomedical Engineering, University of Toronto, 164 College St., Toronto, M5S3G9, Canada.'}]",Applied ergonomics,['10.1016/j.apergo.2020.103230']
2533,32858844,Interleukin-6 Gene Expression Changes after a 4-Week Intake of a Multispecies Probiotic in Major Depressive Disorder-Preliminary Results of the PROVIT Study.,"Major depressive disorder (MDD) is a prevalent disease, in which one third of sufferers do not respond to antidepressants. Probiotics have the potential to be well-tolerated and cost-efficient treatment options. However, the molecular pathways of their effects are not fully elucidated yet. Based on previous literature, we assume that probiotics can positively influence inflammatory mechanisms. We aimed at analyzing the effects of probiotics on gene expression of inflammation genes as part of the randomized, placebo-controlled, multispecies probiotics PROVIT study in Graz, Austria. Fasting blood of 61 inpatients with MDD was collected before and after four weeks of probiotic intake or placebo. We analyzed the effects on gene expression of tumor necrosis factor ( TNF ), nuclear factor kappa B subunit 1 ( NFKB1 ) and interleukin-6 ( IL-6 ). In  IL-6  we found no significant main effects for group ( F (1,44)  = 1.33,  p  = ns) nor time ( F (1,44)  = 0.00,  p  = ns), but interaction was significant ( F (1,44)  = 5.67,  p  < 0.05). The intervention group showed decreasing  IL-6  gene expression levels while the placebo group showed increasing gene expression levels of  IL-6 . Probiotics could be a useful additional treatment in MDD, due to their anti-inflammatory effects. Results of the current study are promising, but further studies are required to investigate the beneficial effects of probiotic interventions in depressed individuals.",2020,"In  IL-6  we found no significant main effects for group ( F (1,44)  = 1.33,  p  = ns) nor time ( F (1,44)  = 0.00,  p  = ns), but interaction was significant ( F (1,44)  = 5.67,  p  < 0.05).",['61 inpatients with MDD'],"['placebo', 'Multispecies Probiotic', 'Probiotics', 'probiotics']","['gene expression levels of  IL-6 ', 'gene expression of tumor necrosis factor ( TNF ), nuclear factor kappa B subunit 1 ( NFKB1 ) and interleukin-6 ( IL-6 ', 'IL-6  gene expression levels']","[{'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}]","[{'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0079904', 'cui_str': 'Immunoglobulin Enhancer-Binding Protein'}, {'cui': 'C0599220', 'cui_str': 'Protein Subunit'}]",61.0,0.0611653,"In  IL-6  we found no significant main effects for group ( F (1,44)  = 1.33,  p  = ns) nor time ( F (1,44)  = 0.00,  p  = ns), but interaction was significant ( F (1,44)  = 5.67,  p  < 0.05).","[{'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Reiter', 'Affiliation': 'Department of Psychiatry and Psychotherapeutic Medicine, Medical University of Graz, Auenbruggerplatz 31, 8036 Graz, Austria.'}, {'ForeName': 'Susanne A', 'Initials': 'SA', 'LastName': 'Bengesser', 'Affiliation': 'Department of Psychiatry and Psychotherapeutic Medicine, Medical University of Graz, Auenbruggerplatz 31, 8036 Graz, Austria.'}, {'ForeName': 'Anne-Christin', 'Initials': 'AC', 'LastName': 'Hauschild', 'Affiliation': 'Department of Mathematics & Computer Science, University of Marburg, 35043 Marburg, Germany.'}, {'ForeName': 'Anna-Maria', 'Initials': 'AM', 'LastName': 'Birkl-Töglhofer', 'Affiliation': 'Institute for Pathology, Neuropathology and Molecular Pathology, Medical University of Innsbruck, 6020 Innsbruck, Austria.'}, {'ForeName': 'Frederike T', 'Initials': 'FT', 'LastName': 'Fellendorf', 'Affiliation': 'Department of Psychiatry and Psychotherapeutic Medicine, Medical University of Graz, Auenbruggerplatz 31, 8036 Graz, Austria.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Platzer', 'Affiliation': 'Department of Psychiatry and Psychotherapeutic Medicine, Medical University of Graz, Auenbruggerplatz 31, 8036 Graz, Austria.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Färber', 'Affiliation': 'Institute of Psychology, University of Bamberg, 96047 Bamberg, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Seidl', 'Affiliation': 'Department of Psychiatry and Psychotherapeutic Medicine, Medical University of Graz, Auenbruggerplatz 31, 8036 Graz, Austria.'}, {'ForeName': 'Lilli-Marie', 'Initials': 'LM', 'LastName': 'Mendel', 'Affiliation': 'Department of Psychiatry and Psychotherapeutic Medicine, Medical University of Graz, Auenbruggerplatz 31, 8036 Graz, Austria.'}, {'ForeName': 'Renate', 'Initials': 'R', 'LastName': 'Unterweger', 'Affiliation': 'Department of Psychiatry and Psychotherapeutic Medicine, Medical University of Graz, Auenbruggerplatz 31, 8036 Graz, Austria.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Lenger', 'Affiliation': 'Department of Psychiatry and Psychotherapeutic Medicine, Medical University of Graz, Auenbruggerplatz 31, 8036 Graz, Austria.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Mörkl', 'Affiliation': 'Department of Psychiatry and Psychotherapeutic Medicine, Medical University of Graz, Auenbruggerplatz 31, 8036 Graz, Austria.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Dalkner', 'Affiliation': 'Department of Psychiatry and Psychotherapeutic Medicine, Medical University of Graz, Auenbruggerplatz 31, 8036 Graz, Austria.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Birner', 'Affiliation': 'Department of Psychiatry and Psychotherapeutic Medicine, Medical University of Graz, Auenbruggerplatz 31, 8036 Graz, Austria.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Queissner', 'Affiliation': 'Department of Psychiatry and Psychotherapeutic Medicine, Medical University of Graz, Auenbruggerplatz 31, 8036 Graz, Austria.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Hamm', 'Affiliation': 'Department of Psychiatry and Psychotherapeutic Medicine, Medical University of Graz, Auenbruggerplatz 31, 8036 Graz, Austria.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Maget', 'Affiliation': 'Department of Psychiatry and Psychotherapeutic Medicine, Medical University of Graz, Auenbruggerplatz 31, 8036 Graz, Austria.'}, {'ForeName': 'Rene', 'Initials': 'R', 'LastName': 'Pilz', 'Affiliation': 'Department of Psychiatry and Psychotherapeutic Medicine, Medical University of Graz, Auenbruggerplatz 31, 8036 Graz, Austria.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Kohlhammer-Dohr', 'Affiliation': 'Department of Psychiatry and Psychotherapeutic Medicine, Medical University of Graz, Auenbruggerplatz 31, 8036 Graz, Austria.'}, {'ForeName': 'Jolana', 'Initials': 'J', 'LastName': 'Wagner-Skacel', 'Affiliation': 'Department of Psychiatry and Psychotherapeutic Medicine, Medical University of Graz, Auenbruggerplatz 31, 8036 Graz, Austria.'}, {'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Kreuzer', 'Affiliation': 'Department of Psychiatry and Psychotherapeutic Medicine, Medical University of Graz, Auenbruggerplatz 31, 8036 Graz, Austria.'}, {'ForeName': 'Helmut', 'Initials': 'H', 'LastName': 'Schöggl', 'Affiliation': 'Department of Psychiatry and Psychotherapeutic Medicine, Medical University of Graz, Auenbruggerplatz 31, 8036 Graz, Austria.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Amberger-Otti', 'Affiliation': 'Department of Psychiatry and Psychotherapeutic Medicine, Medical University of Graz, Auenbruggerplatz 31, 8036 Graz, Austria.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Lahousen', 'Affiliation': 'Department of Psychiatry and Psychotherapeutic Medicine, Medical University of Graz, Auenbruggerplatz 31, 8036 Graz, Austria.'}, {'ForeName': 'Birgitta', 'Initials': 'B', 'LastName': 'Leitner-Afschar', 'Affiliation': 'Department of Psychiatry and Psychotherapeutic Medicine, Medical University of Graz, Auenbruggerplatz 31, 8036 Graz, Austria.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Haybäck', 'Affiliation': 'Institute for Pathology, Neuropathology and Molecular Pathology, Medical University of Innsbruck, 6020 Innsbruck, Austria.'}, {'ForeName': 'Hans-Peter', 'Initials': 'HP', 'LastName': 'Kapfhammer', 'Affiliation': 'Department of Psychiatry and Psychotherapeutic Medicine, Medical University of Graz, Auenbruggerplatz 31, 8036 Graz, Austria.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Reininghaus', 'Affiliation': 'Department of Psychiatry and Psychotherapeutic Medicine, Medical University of Graz, Auenbruggerplatz 31, 8036 Graz, Austria.'}]",Nutrients,['10.3390/nu12092575']
2534,32830802,Using Serious Games to Increase Prevention and Self-Management of Chemotherapy-Induced Nausea and Vomiting in Older Adults With Cancer.,"OBJECTIVES


To examine the frequency and types of preventive and self-management behaviors reported by participants, as well as report acceptability and usability data for the electronic Symptom Self-Management Training-Chemotherapy-Induced Nausea and Vomiting (CINV) serious game.
SAMPLE &AMP; SETTING


80 adults who were aged 60 years or older and newly diagnosed with cancer were recruited from a community cancer center.
METHODS &AMP; VARIABLES


Participants were randomized to an intervention or control group. A symptom management checklist was used to record preventive and self-management behaviors used after each chemotherapy treatment at home. Acceptability and usability were assessed using a brief survey.
RESULTS


The intervention group reported using more preventive behaviors, and the control group reported using more self-management behaviors. Antiemetics were the most common strategy used, followed by dietary strategies. Participants rated all aspects of the serious game highly for usability and acceptability.
IMPLICATIONS FOR NURSING


Oncology providers can help older adults plan for self-managing treatment-related side effects at home. Recording self-management behaviors may reinforce the importance of active prevention and management of CINV.
",2020,"The intervention group reported using more preventive behaviors, and the control group reported using more self-management behaviors.","['80 adults who were aged 60 years or older and newly diagnosed with cancer were recruited from a community cancer center', 'Older Adults With Cancer', 'AMP']",[],"['usability and acceptability', 'Acceptability and usability', 'Nausea and Vomiting']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0001465', 'cui_str': 'Adenosine phosphate'}]",[],"[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}]",80.0,0.0504242,"The intervention group reported using more preventive behaviors, and the control group reported using more self-management behaviors.","[{'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Wochna Loerzel', 'Affiliation': 'University of Central Florida.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Clochesy', 'Affiliation': 'University of Miami.'}, {'ForeName': 'Patricia I', 'Initials': 'PI', 'LastName': 'Geddie', 'Affiliation': 'Orlando Health.'}]",Oncology nursing forum,['10.1188/20.ONF.567-576']
2535,32839221,"A Five-in-One First-in-Human Study To Assess Safety, Tolerability, and Pharmacokinetics of RO7049389, an Inhibitor of Hepatitis B Virus Capsid Assembly, after Single and Multiple Ascending Doses in Healthy Participants.","RO7049389, an inhibitor of hepatitis B virus (HBV) capsid assembly, is being developed for the treatment of patients with chronic HBV infection. The objectives of this first-in-human study are to assess the safety, tolerability, pharmacokinetics (PK), food effect, inhibitory effect on CYP3A, and effect on QT of RO7049389 in healthy participants. Five components, single-ascending-dose (SAD) cohorts, multiple-ascending-dose (MAD) cohorts, food effect assessment, drug-drug interaction assessment, and concentration-QT analysis were integrated in one study (five-in-one). Participants randomly received a single dose of 150 to 2,500 mg RO7049389 or placebo in SAD cohorts ( n  = 41), or multiple doses of 200 to 800 mg RO7049389 or placebo in MAD cohorts ( n  = 42). A single doses of 450 mg RO7049389 was administered under fasted and fed condition. The microdose of midazolam was administered before and after multiple dosing of RO7049389. Safety and tolerability were monitored throughout the study. Serial blood and urine samples were collected for the PK analysis. RO7049389 was safe and well tolerated in healthy participants. Absorption and elimination of RO7049389 occurred rapidly in plasma with minimal recovery in urine. Greater than dose-proportional increases in plasma exposure were observed. Exposure of RO7049389 (450 mg) increased by ∼2-fold when administered with a high-fat meal. The inhibition effect of RO7049389 on CYP3A was weak (<20%). No effect on QT interval was observed at up to a single dose of 2,500 mg. RO7049389 displayed a favorable safety, tolerability and PK profile suitable for further clinical development. (This trial was registered at ClinicalTrials.gov with the identifier NCT02952924.).",2020,The inhibition effect of RO7049389 on CYP3A was weak (< 20%).,"['patients with chronic HBV infection', 'healthy participants']","['RO7049389 or placebo', 'midazolam']","['plasma exposure', 'Serial blood and urine samples', 'Safety and tolerability', 'safety, tolerability, and pharmacokinetics', 'QT interval', 'safe and well tolerated', 'favorable safety, tolerability', 'concentration-QT analysis', 'safety, tolerability, pharmacokinetics (PK), food effect, inhibitory effect on CYP3A']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0524909', 'cui_str': 'Chronic type B viral hepatitis'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C1610733', 'cui_str': 'Urine specimen'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0429028', 'cui_str': 'QT interval feature'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0059563', 'cui_str': 'Cytochrome p450 CYP3A enzyme'}]",,0.0647484,The inhibition effect of RO7049389 on CYP3A was weak (< 20%).,"[{'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Feng', 'Affiliation': 'Pharmaceutical Sciences, Roche Innovation Center Shanghai, Shanghai, China.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Gane', 'Affiliation': 'Auckland Clinical Studies, Auckland, New Zealand.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Schwabe', 'Affiliation': 'Auckland Clinical Studies, Auckland, New Zealand.'}, {'ForeName': 'Mingfen', 'Initials': 'M', 'LastName': 'Zhu', 'Affiliation': 'I2O DTA, Roche Innovation Center Shanghai, Shanghai, China.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Triyatni', 'Affiliation': 'Early Development Safety, Roche Innovation Center Basel, Basel, Switzerland.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Biostatistics, Roche Pharma Product Development Shanghai, Shanghai, China.'}, {'ForeName': 'Qingyan', 'Initials': 'Q', 'LastName': 'Bo', 'Affiliation': 'I2O DTA, Roche Innovation Center Shanghai, Shanghai, China.'}, {'ForeName': 'Yuyan', 'Initials': 'Y', 'LastName': 'Jin', 'Affiliation': 'Pharmaceutical Sciences, Roche Innovation Center Shanghai, Shanghai, China yuyan.jin@roche.com.'}]",Antimicrobial agents and chemotherapy,['10.1128/AAC.01323-20']
2536,32839253,Analgesic efficacy of infiltration between the popliteal artery and capsule of the knee (iPACK) block added to local infiltration analgesia and continuous adductor canal block after total knee arthroplasty: a randomized clinical trial.,"BACKGROUND


A combination of motor-sparing analgesia with local infiltration analgesia (LIA) and continuous adductor canal block (CACB) may improve postoperative pain and functional recovery for total knee arthroplasty (TKA). We hypothesized that the addition of a novel technique for posterior knee block, known as the infiltration between the popliteal artery and capsule of the knee (iPACK) block, to LIA with CACB would reduce opioid requirements.
METHODS


In this double-blinded randomized controlled trial, 72 patients were assigned to receive either LIA with CACB (LIA+CACB group) or iPACK block with LIA and CACB (iPACK+LIA+CACB group). The primary outcome was cumulative postoperative intravenous morphine consumption within 24 hours. The secondary outcomes included numerical rating scale pain scores, incidence of posterior knee pain, performance test results, patient satisfaction, length of stay, and adverse events.
RESULTS


Morphine consumption within 24 hours postoperatively showed no significant intergroup difference (LIA+CACB; 1.31±1.85 mg vs iPACK+LIA+CACB; 0.61±1.25 mg, p=0.08). There were no clinically significant differences in the overall pain scores between the groups. The lower Timed Up and Go test scores on postoperative days 1 and 2, along with a shorter duration of hospitalization, were found in the iPACK+LIA+CACB group (p<0.05).
CONCLUSION


The addition of an iPACK block to the LIA and CACB does not reduce the postoperative opioid consumption nor improve analgesia. However, it may improve immediate functional performance and reduce the length of hospitalization after TKA.
TRIAL REGISTRATION NUMBER


TCTR20180702001.",2020,The addition of an iPACK block to the LIA and CACB does not reduce the postoperative opioid consumption nor improve analgesia.,"['total knee arthroplasty (TKA', '72 patients', 'total knee arthroplasty']","['motor-sparing analgesia with local infiltration analgesia (LIA) and continuous adductor canal block (CACB', 'local infiltration analgesia and continuous adductor canal block', 'iPACK+LIA+CACB', 'LIA with CACB (LIA+CACB group) or iPACK block with LIA and CACB (iPACK+LIA+CACB group']","['cumulative postoperative intravenous morphine consumption', 'immediate functional performance', 'postoperative opioid consumption nor improve analgesia', 'numerical rating scale pain scores, incidence of posterior knee pain, performance test results, patient satisfaction, length of stay, and adverse events', 'overall pain scores', 'Analgesic efficacy']","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1843661', 'cui_str': 'Spastic Paraplegia, Ataxia, And Mental Retardation'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0225273', 'cui_str': 'Structure of adductor canal'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0032649', 'cui_str': 'Structure of popliteal artery'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0456984', 'cui_str': 'Test finding'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",72.0,0.504575,The addition of an iPACK block to the LIA and CACB does not reduce the postoperative opioid consumption nor improve analgesia.,"[{'ForeName': 'Chutikant', 'Initials': 'C', 'LastName': 'Vichainarong', 'Affiliation': 'Anesthesiology, King Chulalongkorn Memorial Hospital, The Thai Red Cross Society and Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Wirinaree', 'Initials': 'W', 'LastName': 'Kampitak', 'Affiliation': 'Anesthesiology, King Chulalongkorn Memorial Hospital, The Thai Red Cross Society and Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand nutong127@yahoo.com.'}, {'ForeName': 'Aree', 'Initials': 'A', 'LastName': 'Tanavalee', 'Affiliation': 'Orthopedics, King Chulalongkorn Memorial Hospital and Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Srihatach', 'Initials': 'S', 'LastName': 'Ngarmukos', 'Affiliation': 'Orthopedics, King Chulalongkorn Memorial Hospital and Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Nattaporn', 'Initials': 'N', 'LastName': 'Songborassamee', 'Affiliation': 'Anesthesiology, King Chulalongkorn Memorial Hospital, The Thai Red Cross Society and Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}]",Regional anesthesia and pain medicine,['10.1136/rapm-2020-101396']
2537,32835958,Enhancing extinction with response prevention via imagery-based counterconditioning: Results on conditioned avoidance and distress.,"BACKGROUND AND OBJECTIVES


Maladaptive avoidance is a core characteristic of anxiety-related disorders. Its reduction is often promoted using extinction with response prevention (ExRP) procedures, but these effects are often short-lived. Research has shown that pairing a feared stimulus with a stimulus of an incompatible valence (i.e., counterconditioning) may be effective in reducing fear. This laboratory study tested whether positive imagery during ExRP (i.e., imagery counterconditioning protocol) can also reduce avoidance.
METHODS


In the counterconditioning procedure, participants imagined a positive sound. There were four phases. First, participants were presented with squares on a computer screen of which one (CS+) was paired with an aversive sound and another (CS-) was not. Second, they learned to avoid the negative sound in the presence of the CS+, via a key press. Third, they were assigned to either the Counterconditioning (that was asked to imagine a positive sound during ExRP) or No Counterconditioning group (standard ExRP). Finally, they performed a test phase that consisted of two parts: in the first part, avoidance responses were available for each CS and in the second part, these responses were prevented.
RESULTS


The Counterconditioning intervention resulted in a short-lived reduction of distress associated with the CS+. However, groups did not differ in avoidance or distress during the test phases.
LIMITATIONS


US-expectancy ratings were collected only at the end of the experiment.
CONCLUSIONS


The results indicate that positive imagery during ExRP may be effective in reducing distress during the intervention. Explanations for the persistence of avoidance and fear are discussed.",2020,"However, groups did not differ in avoidance or distress during the test phases.
",[],['Counterconditioning (that was asked to imagine a positive sound during ExRP) or No Counterconditioning group (standard ExRP'],"['avoidance or distress', 'distress']",[],"[{'cui': 'C1172410', 'cui_str': 'ASK protein, human'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0037709', 'cui_str': 'Sonic Radiation'}, {'cui': 'C0015347', 'cui_str': 'Psychological Extinction'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0231303', 'cui_str': 'Distress'}]",,0.037803,"However, groups did not differ in avoidance or distress during the test phases.
","[{'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Hendrikx', 'Affiliation': 'Department of Clinical Psychology, Utrecht University, the Netherlands.'}, {'ForeName': 'Angelos-Miltiadis', 'Initials': 'AM', 'LastName': 'Krypotos', 'Affiliation': 'Department of Clinical Psychology, Utrecht University, the Netherlands; Department of Healthy Psychology, KU Leuven, Belgium. Electronic address: amkrypotos@gmail.com.'}, {'ForeName': 'Iris M', 'Initials': 'IM', 'LastName': 'Engelhard', 'Affiliation': 'Department of Clinical Psychology, Utrecht University, the Netherlands.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101601']
2538,32844217,Relating Bone Strain to Local Changes in Radius Microstructure Following 12 Months of Axial Forearm Loading in Women.,"Work in animal models suggest that bone structure adapts to local bone strain, but this relationship has not been comprehensively studied in humans. Here, we quantified the influence of strain magnitude and gradient on bone adaptation in the forearm of premenopausal women performing compressive forearm loading (n=11) and non-loading controls (n=10). High resolution peripheral quantitative computed tomography (HRpQCT) scans of the distal radius acquired at baseline and 12 months of a randomized controlled experiment were used to identify local sites of bone formation and resorption. Bone strain was estimated using validated finite element (FE) models. Trabecular strain magnitude and gradient were higher near (within 200 µm) formation versus resorption (p<0.05). Trabecular formation and resorption occurred preferentially near very high (>95th percentile) versus low (<5th percentile) strain magnitude and gradient elements, and very low strain elements were more likely to be near resorption than formation (p<0.05). In the cortical compartment, strain gradient was higher near formation versus resorption (p<0.05), and both formation and resorption occurred preferentially near very high versus low strain gradient elements (p<0.05). At most, 54% of very high and low strain elements were near formation or resorption only, and similar trends were observed in the control and load groups. These findings suggest that strain, likely in combination with other physiological factors, influences adaptation under normal loads and in response to a novel loading intervention, and represents an important step toward defining exercise interventions to maximize bone strength.",2020,Trabecular strain magnitude and gradient were higher near (within 200 µm) formation versus resorption (p<0.05).,"['premenopausal women performing compressive forearm loading (n=11) and non-loading controls (n=10', 'Radius Microstructure']",['High resolution peripheral quantitative computed tomography (HRpQCT) scans'],"['Bone strain', 'near formation or resorption', 'formation and resorption', 'Trabecular formation and resorption']","[{'cui': 'C1096235', 'cui_str': 'Premenopausal symptoms'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0016536', 'cui_str': 'Forearm structure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0034627', 'cui_str': 'Bone structure of radius'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0412669', 'cui_str': 'Computerized tomography, bone density study'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}]","[{'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}]",,0.024878,Trabecular strain magnitude and gradient were higher near (within 200 µm) formation versus resorption (p<0.05).,"[{'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Mancuso', 'Affiliation': 'Department of Biomedical Engineering, Worcester Polytechnic Institute, 100 Institute Road, Worcester, MA 01609.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Troy', 'Affiliation': 'Department of Biomedical Engineering, Worcester Polytechnic Institute, 100 Institute Road, Worcester, MA 01609.'}]",Journal of biomechanical engineering,['10.1115/1.4048232']
2539,32853900,Effects of a mindfulness-based childbirth and parenting program on maternal-fetal attachment: A randomized controlled trial among Iranian pregnant women.,"BACKGROUND AND PURPOSE


Although mindfulness-based childbirth and parenting is suggested to promote maternal-fetal attachment, no study has yet addressed its potential effects. This study aimed to determine the effects of a mindfulness-based childbirth and parenting program on maternal-fetal attachment among Iranian pregnant women.
MATERIALS AND METHODS


This study was conducted on pregnant women, who were divided into two groups to either receive routine care plus mindfulness training for childbirth and parenting (i.e., eight 2-h group sessions once a week and one 3-h session of silent meditation) or receive routine care alone. Maternal-fetal attachment was evaluated by the Cranley's Maternal-Fetal Attachment Scale.
RESULTS


After the intervention, the total score of maternal-fetal attachment was significantly higher in the experimental group (P < 0.001; effect size = 0.640). In the intervention group, all dimensions of maternal-fetal attachment significantly improved, except the dimension of ""differentiation of self from the fetus"", whereas in the control group, only the dimension of ""attributing characteristics to the fetus"" improved.
CONCLUSION


The implemented program in this study was potentially effective in promoting maternal-fetal attachment.",2020,"In the intervention group, all dimensions of maternal-fetal attachment significantly improved, except the dimension of ""differentiation of self from the fetus"", whereas in the control group, only the dimension of ""attributing characteristics to the fetus"" improved.
","['pregnant women', 'Iranian pregnant women']","['routine care plus mindfulness training', 'routine care alone', 'mindfulness-based childbirth and parenting program']","['dimension of ""attributing characteristics to the fetus"" improved', 'total score of maternal-fetal attachment', 'dimension of ""differentiation of self from the fetus', 'Maternal-fetal attachment', 'maternal-fetal attachment', ""Cranley's Maternal-Fetal Attachment Scale""]","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0449234', 'cui_str': 'Attribute'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0007589', 'cui_str': 'Differentiation, Cell'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.0224299,"In the intervention group, all dimensions of maternal-fetal attachment significantly improved, except the dimension of ""differentiation of self from the fetus"", whereas in the control group, only the dimension of ""attributing characteristics to the fetus"" improved.
","[{'ForeName': 'Zeinab', 'Initials': 'Z', 'LastName': 'Gheibi', 'Affiliation': 'Student Research Committee, Department of Midwifery, School of Nursing and Midwifery, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran. Electronic address: Zeinab_gheibi@yahoo.com.'}, {'ForeName': 'Zabihollah', 'Initials': 'Z', 'LastName': 'Abbaspour', 'Affiliation': 'Department of Psychology, School of Education and Psychology, Shahid Chamran University of Ahvaz, Ahvaz, Iran. Electronic address: Zabbaspour1356@gmail.com.'}, {'ForeName': 'Mohammad Hossein', 'Initials': 'MH', 'LastName': 'Haghighyzadeh', 'Affiliation': 'Department of Biostatistics and Epidemiology, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran. Electronic address: Haghighy-mh@ajums.ac.ir.'}, {'ForeName': 'Nahid', 'Initials': 'N', 'LastName': 'Javadifar', 'Affiliation': 'Reproductive Health Promotion Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran. Electronic address: Javadifar-n@ajums.ac.ir.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101226']
2540,32854000,Abstinence-reinforcing contingency management improves HIV viral load suppression among HIV-infected people who use drugs: A randomized controlled trial.,"BACKGROUND


HIV-infected people who use drugs (PWUD) have poor HIV outcomes. Few studies tested interventions to improve HIV outcomes among PWUD. Abstinence-reinforcing contingency management (CM) reduces drug use and could also improve HIV outcomes.
METHODS


From 2012-2017, we conducted a randomized controlled trial testing whether a 16-week abstinence-reinforcing CM intervention improved HIV viral load (VL) among HIV-infected adults using opioids or cocaine. In the CM intervention, drug-free urines led to escalating value of vouchers ($2.50-$80/voucher, $1320 total maximum). In intention-to-treat mixed-effects linear and logistic regression analyses, we examined whether the CM intervention improved log 10  VL (primary outcome), abstinence and antiretroviral adherence (secondary outcomes).
RESULTS


Thirty-seven participants were randomized to the CM intervention and 36 to control. Median age was 49.2 years; most were male (61.6%) and non-Hispanic black (46.6%). In CM (vs. control) participants, mean reduction in log 10  VL was greater (-0.16 log 10  VL copies/mL per 4-week period; 95% CI: -0.29 to -0.03, p < 0.05). Over 16 weeks, CM participants had a mean reduction of 0.64 copies/mL in log 10  VL greater than control participants. The CM intervention was not significantly associated with abstinence or adherence.
CONCLUSIONS


This is the first study to demonstrate improvements in HIV VL via an abstinence-reinforcing CM intervention. Because the CM intervention did not significantly affect abstinence or adherence, the mechanism of its effect is unclear. To end the HIV epidemic, innovative strategies must address individuals with poor HIV outcomes. Abstinence-reinforcing CM may be one potential strategy to improve HIV outcomes among a select group of PWUD.",2020,"Over 16 weeks, CM participants had a mean reduction of 0.64 copies/mL in log 10  VL greater than control participants.","['From 2012-2017', 'HIV-infected people who use drugs', 'Thirty-seven participants', 'HIV-infected adults using', 'Median age was 49.2 years; most were male (61.6%) and non-Hispanic black (46.6']","['opioids or cocaine', 'Abstinence-reinforcing contingency management (CM', 'CM intervention', 'abstinence-reinforcing CM intervention', 'Abstinence-reinforcing contingency management']","['mean reduction in log 10  VL', 'log 10  VL (primary outcome), abstinence and antiretroviral adherence (secondary outcomes', 'HIV viral load suppression', 'HIV outcomes', 'HIV viral load (VL', 'abstinence or adherence']","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}, {'cui': 'C4319569', 'cui_str': '37'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}]","[{'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1168369', 'cui_str': 'HIV viral load'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}]",37.0,0.178726,"Over 16 weeks, CM participants had a mean reduction of 0.64 copies/mL in log 10  VL greater than control participants.","[{'ForeName': 'Chinazo O', 'Initials': 'CO', 'LastName': 'Cunningham', 'Affiliation': 'Albert Einstein College of Medicine & Montefiore Medical Center, 111 E. 210th Street, Bronx, NY 10467, United States. Electronic address: ccunning@montefiore.org.'}, {'ForeName': 'Julia H', 'Initials': 'JH', 'LastName': 'Arnsten', 'Affiliation': 'Albert Einstein College of Medicine & Montefiore Medical Center, 111 E. 210th Street, Bronx, NY 10467, United States.'}, {'ForeName': 'Chenshu', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Albert Einstein College of Medicine & Montefiore Medical Center, 111 E. 210th Street, Bronx, NY 10467, United States.'}, {'ForeName': 'Moonseong', 'Initials': 'M', 'LastName': 'Heo', 'Affiliation': 'Albert Einstein College of Medicine & Montefiore Medical Center, 111 E. 210th Street, Bronx, NY 10467, United States; Clemson University College of Behavioral, Social and Health Sciences, Department of Public Health Sciences, Clemson Nursing Building, 605 Grove Road, Greenville, SC 29605, United States.'}, {'ForeName': 'Marcus A', 'Initials': 'MA', 'LastName': 'Bachhuber', 'Affiliation': 'Albert Einstein College of Medicine & Montefiore Medical Center, 111 E. 210th Street, Bronx, NY 10467, United States; Lousiana State University Health Sciences Center-New Orleans, Section of Community and Population Medicine, Department of Medicine, 533 Bolivar St, New Orleans, LA 70112, United States.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Jost', 'Affiliation': 'Albert Einstein College of Medicine & Montefiore Medical Center, 111 E. 210th Street, Bronx, NY 10467, United States.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Grossberg', 'Affiliation': 'Albert Einstein College of Medicine & Montefiore Medical Center, 111 E. 210th Street, Bronx, NY 10467, United States.'}, {'ForeName': 'Melissa R', 'Initials': 'MR', 'LastName': 'Stein', 'Affiliation': 'Albert Einstein College of Medicine & Montefiore Medical Center, 111 E. 210th Street, Bronx, NY 10467, United States.'}, {'ForeName': 'Nancy L', 'Initials': 'NL', 'LastName': 'Sohler', 'Affiliation': 'City University of New York, School of Medicine, 160 Convent Ave, New York, NY 10031, United States.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108230']
2541,32860117,The effect of breaking up prolonged sitting on paired associative stimulation-induced plasticity.,"Paired associative stimulation (PAS) can induce plasticity in the motor cortex, as measured by changes in corticospinal excitability (CSE). This effect is attenuated in older and less active individuals. Although a single bout of exercise enhances PAS-induced plasticity in young, physically inactive adults, it is not yet known if physical activity interventions affect PAS-induced neuroplasticity in middle-aged inactive individuals. Sixteen inactive middle-aged office workers participated in a randomized cross-over design investigating how CSE and short-interval intracortical inhibition (SICI) were affected by PAS preceded by 3 h of sitting (SIT), 3 h of sitting interrupted every 30 min by 3 min of frequent short bouts of physical activity (FPA) and 2.5 h of sitting followed by 25 min of moderate-intensity exercise (EXE). Transcranial magnetic stimulation was applied over the primary motor cortex (M1) of the dominant abductor pollicis brevis to induce recruitment curves before and 5 min and 30 min post-PAS. Linear mixed models were used to compare changes in CSE using time and condition as fixed effects and subjects as random effects. There was a main effect of time on CSE and planned within-condition comparisons showed that CSE was significantly increased from baseline to 5 min and 30 min post-PAS, in the FPA condition, with no significant changes in the SIT or EXE conditions. SICI decreased from baseline to 5 min post-PAS, but this was not related to changes in CSE. Our findings suggest that in middle-aged inactive adults, FPAs may promote corticospinal neuroplasticity. Possible mechanisms are discussed.",2020,"Paired associative stimulation (PAS) can induce plasticity in the motor cortex, as measured by changes in corticospinal excitability (CSE).","['older and less active individuals', 'middle-aged inactive individuals', 'Sixteen inactive middle-aged office workers']","['CSE and short-interval intracortical inhibition (SICI) were affected by PAS preceded by 3\xa0h of sitting (SIT), 3\xa0h of sitting interrupted every 30\xa0min by 3\xa0min of frequent short bouts of physical activity (FPA) and 2.5\xa0h of sitting followed by 25\xa0min of moderate-intensity exercise (EXE', 'Paired associative stimulation (PAS', 'Transcranial magnetic stimulation']","['CSE', 'SICI']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C1306056', 'cui_str': 'Worker'}]","[{'cui': 'C0235169', 'cui_str': 'Excitability'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0041119', 'cui_str': 'Tritium'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0443239', 'cui_str': 'Interrupted'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}]","[{'cui': 'C0235169', 'cui_str': 'Excitability'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}]",,0.106179,"Paired associative stimulation (PAS) can induce plasticity in the motor cortex, as measured by changes in corticospinal excitability (CSE).","[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Bojsen-Møller', 'Affiliation': 'The Swedish School of Sport and Health Sciences, GIH, 11486, Stockholm, Sweden. emil.bojsen.moller@gih.se.'}, {'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Ekblom', 'Affiliation': 'The Swedish School of Sport and Health Sciences, GIH, 11486, Stockholm, Sweden.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Tarassova', 'Affiliation': 'The Swedish School of Sport and Health Sciences, GIH, 11486, Stockholm, Sweden.'}, {'ForeName': 'D W', 'Initials': 'DW', 'LastName': 'Dunstan', 'Affiliation': 'Baker Heart and Diabetes Institute, Melbourne, VIC, Australia.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Ekblom', 'Affiliation': 'The Swedish School of Sport and Health Sciences, GIH, 11486, Stockholm, Sweden.'}]",Experimental brain research,['10.1007/s00221-020-05866-z']
2542,32860331,Patient-reported tolerability of veliparib combined with cisplatin and etoposide for treatment of extensive stage small cell lung cancer: Neurotoxicity and adherence data from the ECOG ACRIN cancer research group E2511 phase II randomized trial.,"OBJECTIVES


The ECOG-ACRIN Cancer Research Group trial E2511 recently demonstrated a potential benefit for the addition of veliparib to cisplatin-etoposide (CE) in patients with extensive stage small cell lung cancer (ES-SCLC) in a phase II randomized controlled trial. Secondary trial endpoints included comparison of the incidence and severity of neurotoxicity, hypothesized to be lower in the veliparib arm, and tolerability of the addition of veliparib to CE. Physician-rated and patient-reported neurotoxicity was also compared.
MATERIALS AND METHODS


Patients randomized to veliparib plus CE (n = 64) or placebo plus CE (n = 64) completed the 11-item Functional Assessment of Cancer Therapy Gynecologic Oncology Group Neurotoxicity (questionnaire pre-treatment, end of cycle 4 [ie 3 months after randomization] and 3 months post-treatment [ie 6-months]). Adherence analysis was based on treatment forms.
RESULTS AND CONCLUSION


No significant differences in mean or magnitude of change in neurotoxicity scores were observed between treatment arms at any time point. However, patients in the placebo arm reported worsening neurotoxicity from baseline to 3-months (M difference = -1.5, P = .045), compared to stable neurotoxicity in the veliparib arm (M difference = -0.2, P = .778). Weakness was the most common treatment-emergent (>50%) and moderate to severe (>16%) symptom reported, but did not differ between treatment arms. The proportion of adherence to oral therapy in the overall sample was 75%. Three percent of patients reported clinically significant neurotoxicity that was not captured by physician assessment. Neurotoxicity scores were not different between treatment arms. The addition of veliparib to CE appeared tolerable, though weakness should be monitored. CLINICALTRIALS.
GOV IDENTIFIER


NCT01642251.",2020,No significant differences in mean or magnitude of change in neurotoxicity scores were observed between treatment arms at any time point.,"['patients with extensive stage small cell lung cancer (ES-SCLC', 'n\xa0=\xa064) or', 'extensive stage small cell lung cancer']","['veliparib combined with cisplatin and etoposide', 'veliparib plus CE', 'placebo', 'veliparib to cisplatin-etoposide (CE', 'placebo plus CE', '11-item Functional Assessment of Cancer Therapy Gynecologic Oncology Group Neurotoxicity (questionnaire pre-treatment']","['mean or magnitude of change in neurotoxicity scores', 'moderate to severe', 'worsening neurotoxicity', 'incidence and severity of neurotoxicity, hypothesized to be lower in the veliparib arm, and tolerability of the addition of veliparib to CE', 'stable neurotoxicity', 'Neurotoxicity scores', 'Weakness', 'neurotoxicity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278726', 'cui_str': 'Small cell lung cancer extensive stage'}]","[{'cui': 'C1958300', 'cui_str': 'veliparib'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0078414', 'cui_str': 'VP-P protocol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1321164', 'cui_str': 'Gynecological oncology'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0235032', 'cui_str': 'Neurotoxicity'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449286', 'cui_str': 'Degree'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0235032', 'cui_str': 'Neurotoxicity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1958300', 'cui_str': 'veliparib'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0078414', 'cui_str': 'VP-P protocol'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C3714552', 'cui_str': 'Debility'}]",,0.208248,No significant differences in mean or magnitude of change in neurotoxicity scores were observed between treatment arms at any time point.,"[{'ForeName': 'Laurie E', 'Initials': 'LE', 'LastName': 'Steffen McLouth', 'Affiliation': 'Department of Behavioral Science, Center for Health Equity Transformation, University of Kentucky College of Medicine, Lexington, KY, USA.'}, {'ForeName': 'Fengmin', 'Initials': 'F', 'LastName': 'Zhao', 'Affiliation': 'Dana-Farber Cancer Institute & ECOG-ACRIN Biostatistics Center, Boston, MA, USA.'}, {'ForeName': 'Taofeek K', 'Initials': 'TK', 'LastName': 'Owonikoko', 'Affiliation': 'Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Josephine L', 'Initials': 'JL', 'LastName': 'Feliciano', 'Affiliation': 'Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Nisha A', 'Initials': 'NA', 'LastName': 'Mohindra', 'Affiliation': 'Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Suzanne E', 'Initials': 'SE', 'LastName': 'Dahlberg', 'Affiliation': 'Dana-Farber Cancer Institute & ECOG-ACRIN Biostatistics Center, Boston, MA, USA.'}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Wade', 'Affiliation': 'Heartland NCORP, Decatur, IL, USA.'}, {'ForeName': 'Gordan', 'Initials': 'G', 'LastName': 'Srkalovic', 'Affiliation': 'Sparrow Herbert-Herman Cancer Center, Lansing, MI, USA.'}, {'ForeName': 'Bradley W', 'Initials': 'BW', 'LastName': 'Lash', 'Affiliation': 'Guthrie Clinic - Robert Packer Hospital, Sayre, USA.'}, {'ForeName': 'Joseph W', 'Initials': 'JW', 'LastName': 'Leach', 'Affiliation': 'Metro Minnesota NCORP, Minneapolis, MN, USA.'}, {'ForeName': 'Ticiana A', 'Initials': 'TA', 'LastName': 'Leal', 'Affiliation': 'University of Wisconsin Carbone Cancer Center, Madison, WI, USA.'}, {'ForeName': 'Charu', 'Initials': 'C', 'LastName': 'Aggarwal', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cella', 'Affiliation': 'Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Suresh S', 'Initials': 'SS', 'LastName': 'Ramalingam', 'Affiliation': 'Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Lynne I', 'Initials': 'LI', 'LastName': 'Wagner', 'Affiliation': 'Department of Social Sciences & Health Policy, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}]",Cancer medicine,['10.1002/cam4.3416']
2543,32847980,Circulating Tumor Cells In Advanced Cervical Cancer: NRG Oncology-Gynecologic Oncology Group Study 240 (NCT 00803062).,"To isolate circulating tumor cells (CTC) from women with advanced cervical cancer and estimate the impact of CTCs and treatment on overall survival and progression-free survival (PFS). A total of 7.5 mL of whole blood was drawn pre-cycle 1 and 36 days post-cycle 1 from patients enrolled on Gynecologic Oncology Group 0240, the phase III randomized trial that led directly to regulatory approval of the antiangiogenesis drug, bevacizumab, in women with recurrent/metastatic cervical cancer. CTCs (defined as anti-cytokeratin + /anti-CD45 -  cells) were isolated from the buffy coat layer using an anti-EpCAM antibody-conjugated ferrofluid and rare earth magnet, and counted using a semiautomated fluorescence microscope. The median pre-cycle 1 CTC count was 7 CTCs/7.5 mL whole blood (range, 0-18) and, at 36 days posttreatment, was 4 (range, 0-17). The greater the declination in CTCs between time points studied, the lower the risk of death [HR, 0.87; 95% confidence interval (CI), 0.79-0.95)]. Among patients with high (≥ median) pretreatment CTCs, bevacizumab treatment was associated with a reduction in the hazard of death (HR, 0.57; 95% CI, 0.32-1.03) and PFS (HR, 0.59; 95% CI, 0.36-0.96). This effect was not observed with low (< median) CTCs. CTCs can be isolated from women with advanced cervical cancer and may have prognostic significance. A survival benefit conferred by bevacizumab among patients with high pretreatment CTCs may reflect increased tumor neovascularization and concomitant vulnerability to VEGF inhibition. These data support studying CTC capture as a potential predictive biomarker.",2020,"The greater the declination in CTCs between time points studied, the lower the risk of death (HR 0.87; 95% CI, 0.79-0.95).","['Advanced Cervical Cancer', 'women with advanced cervical cancer', 'women with recurrent/metastatic cervical cancer']","['regulatory approval of the anti-angiogenesis drug, bevacizumab', 'bevacizumab']","['median pre-cycle 1 CTC count', 'overall survival (OS) and progression-free survival (PFS', 'risk of death', 'declination in CTCs', 'hazard of death']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0278584', 'cui_str': 'Cervix cancer metastatic'}]","[{'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0027625', 'cui_str': 'Circulating Neoplastic Cells'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.128951,"The greater the declination in CTCs between time points studied, the lower the risk of death (HR 0.87; 95% CI, 0.79-0.95).","[{'ForeName': 'Krishnansu S', 'Initials': 'KS', 'LastName': 'Tewari', 'Affiliation': 'UC Irvine Medical Center, Orange, California. ktewari@uci.edu.'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Sill', 'Affiliation': 'NRG Oncology/Gynecologic Oncology Group, SUNY at Buffalo, Buffalo, New York.'}, {'ForeName': 'Bradley J', 'Initials': 'BJ', 'LastName': 'Monk', 'Affiliation': ""University of Arizona Cancer Center and Creighton University at St. Joseph's Hospital and Medical Center, Phoenix, Arizona.""}, {'ForeName': 'Richard T', 'Initials': 'RT', 'LastName': 'Penson', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Moore', 'Affiliation': 'Franciscan St. Francis Health-Indianapolis, Indianapolis, Indiana.'}, {'ForeName': 'Heather A', 'Initials': 'HA', 'LastName': 'Lankes', 'Affiliation': 'NRG Oncology/Gynecologic Oncology Group, SUNY at Buffalo, Buffalo, New York.'}, {'ForeName': 'Lois M', 'Initials': 'LM', 'LastName': 'Ramondetta', 'Affiliation': 'MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Landrum', 'Affiliation': 'Oklahoma University Health Science Center, Oklahoma City, Oklahoma.'}, {'ForeName': 'Leslie M', 'Initials': 'LM', 'LastName': 'Randall', 'Affiliation': 'UC Irvine Medical Center, Orange, California.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Oaknin', 'Affiliation': 'Grupo Espanol de Investigacion en Cancer de Ovario (GEICO), Barcelona, Spain.'}, {'ForeName': 'Mario M', 'Initials': 'MM', 'LastName': 'Leitao', 'Affiliation': 'Memorial Sloan-Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Eric L', 'Initials': 'EL', 'LastName': 'Eisenhauer', 'Affiliation': 'University of Cincinnati, Cincinnati, Ohio.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'DiSilvestro', 'Affiliation': 'Women & Infants Hospital, Providence, Rhode Island.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Van Le', 'Affiliation': 'University of North Carolina, Chapel Hill, North Carolina.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Pearl', 'Affiliation': 'Stony Brook University Medical Center, Stony Brook, New York.'}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Burke', 'Affiliation': 'Southeast Cancer Control Consortium CCOP, Winston-Salem, North Carolina.'}, {'ForeName': 'Ritu', 'Initials': 'R', 'LastName': 'Salani', 'Affiliation': 'The Ohio State University Medical Center, Columbus, Ohio.'}, {'ForeName': 'Debra L', 'Initials': 'DL', 'LastName': 'Richardson', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Helen E', 'Initials': 'HE', 'LastName': 'Michael', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Kindelberger', 'Affiliation': 'Boston Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Birrer', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}]",Molecular cancer therapeutics,['10.1158/1535-7163.MCT-20-0276']
2544,32845968,Long-term Change in Physiological Markers and Cognitive Performance in Type 2 Diabetes: The Look AHEAD Study.,"CONTEXT


The effects of physiological improvements on cognitive function among persons with type 2 diabetes mellitus (T2DM) are not fully understood.
OBJECTIVE


To determine whether improvements in physiological markers (body weight, blood sugar control, and physical activity) during intensive lifestyle intervention (ILI) are associated with enhancements in cognitive function in older adults with T2DM.
DESIGN


Multisite randomized controlled trial.
SETTING


Academic research centers.
PATIENTS OR OTHER PARTICIPANTS


Participants were aged 45-76 years, with T2DM.
INTERVENTION


The Action for Health in Diabetes (Look AHEAD) study, a randomized, controlled clinical trial of ILI.
MAIN OUTCOME MEASURE


Two to 3 cognitive assessments were collected from 1089 participants, the first and last occurring a mean (standard deviation) of 8.6 (1.0) and 11.5 (0.7) years after enrollment.
RESULTS


Greater improvement in blood sugar control was associated with better cognitive scores (fasting glucose and Rey Auditory Verbal Learning Test [AVLT]: P = 0.0148; fasting glucose and Digit Symbol Coding (DSC): P = 0.0360; HbA1C and DSC: P = 0.0477); but weight loss had mixed associations with cognitive scores (greater body mass index [BMI] reduction and worse AVLT overall: P = 0.0053; and greater BMI reduction and better DSC scores among those overweight but not obese at baseline: P = 0.010). Associations were strongest among those who were overweight (not obese) at baseline, and among those with a history of cardiovascular disease (CVD) at baseline.
CONCLUSIONS


Improvements in glycemic control, but not necessarily weight status, during ILI may be associated with better subsequent cognitive performance. These associations may differ by adiposity and CVD history.",2020,"RESULTS


Greater improvements in blood sugar control were associated with better cognitive scores (fasting glucose and Rey Auditory Verbal Learning Test, AVLT: p=.0148, fasting glucose and Digit Symbol Coding, DSC:","['persons with type 2 diabetes mellitus (T2DM', 'Diabetes', 'Academic research centers', 'type 2 diabetes', 'Participants were aged 45-76 years with T2DM', '1089 participants, the first and last occurring a mean [standard deviation] of 8.6 [1.0] and 11.5 [.7', 'older adults with T2DM']","['HbA1C and DSC', 'intensive lifestyle intervention (ILI']","['BMI reduction and better DSC scores', 'blood sugar control', 'physiological markers and cognitive performance', 'cognitive function', 'cognitive scores (fasting glucose and Rey Auditory Verbal Learning Test, AVLT: p=.0148, fasting glucose and Digit Symbol Coding, DSC', 'physiological markers (body weight, blood sugar control, and physical activity']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C4517879', 'cui_str': '8.6'}, {'cui': 'C4517534', 'cui_str': '11.5'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C4505058', 'cui_str': 'Rey Auditory Verbal Learning Test'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",1089.0,0.0476723,"RESULTS


Greater improvements in blood sugar control were associated with better cognitive scores (fasting glucose and Rey Auditory Verbal Learning Test, AVLT: p=.0148, fasting glucose and Digit Symbol Coding, DSC:","[{'ForeName': 'Owen T', 'Initials': 'OT', 'LastName': 'Carmichael', 'Affiliation': 'Biomedical Imaging Center, Pennington Biomedical Research Center, Baton Rouge, Louisiana.'}, {'ForeName': 'Rebecca H', 'Initials': 'RH', 'LastName': 'Neiberg', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Gareth R', 'Initials': 'GR', 'LastName': 'Dutton', 'Affiliation': 'Department of Medicine, Division of Preventive Medicine, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Hayden', 'Affiliation': 'Social Sciences and Health Policy, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Horton', 'Affiliation': 'Joslin Diabetes Center, Harvard University, Boston, Massachusetts.'}, {'ForeName': 'F Xavier', 'Initials': 'FX', 'LastName': 'Pi-Sunyer', 'Affiliation': 'Division of Endocrinology, Obesity/Nutrition Research Center, Columbia University College of Physicians and Surgeons, New York, NY.'}, {'ForeName': 'Karen C', 'Initials': 'KC', 'LastName': 'Johnson', 'Affiliation': 'Department of Preventive Medicine, The University of Tennessee Health Science Center, Memphis, Tennessee.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Rapp', 'Affiliation': 'Department of Psychiatry & Behavioral Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Adam P', 'Initials': 'AP', 'LastName': 'Spira', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Espeland', 'Affiliation': 'Division of Gerontology and Geriatric Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa591']
2545,32865079,Participant Satisfaction with Computer-Delivered Intervention Components and Its Relation to Alcohol Outcomes.,"BACKGROUND


Few computer-delivered brief intervention (CDBI) studies have evaluated participant satisfaction with individual elements of the intervention, or whether participant satisfaction impacts intervention outcomes.  Purpose:  This factorial trial examined whether subjective reactions to a CDBI for heavy drinking (1) varied depending on the presence versus absence of an animated narrator, a spoken voice, empathic reflections, and motivational interviewing (MI) strategies and (2) were associated with drinking outcomes at 3-month follow-up.  Methods:  Participants were 352 heavy drinking university students. All participants were randomly assigned to one of 16 versions of a CDBI. After finishing the CDBI, participants completed measures of intervention likability and perceived empathy. Alcohol use outcomes were assessed at 3-month follow-up.  Results:  CDBI characteristics had minimal effects on participant ratings of likeability and perceived empathy. However, higher likeability ratings were associated with decreases in alcohol use outcomes over the 3-month assessment period.  Conclusions:  Results indicate that subjective reactions to CDBIs can have important effects on alcohol use outcomes.",2020,CDBI characteristics had minimal effects on participant ratings of likeability and perceived empathy.,['Participants were 352 heavy drinking university students'],[],"['intervention likability and perceived empathy', 'higher likeability ratings', 'participant ratings of likeability and perceived empathy']","[{'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}]",[],"[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0205250', 'cui_str': 'High'}]",,0.0194355,CDBI characteristics had minimal effects on participant ratings of likeability and perceived empathy.,"[{'ForeName': 'Marina C', 'Initials': 'MC', 'LastName': 'Fodor', 'Affiliation': 'Department of Psychology, Wayne State University, Detroit, Michigan, USA.'}, {'ForeName': 'Emily R', 'Initials': 'ER', 'LastName': 'Grekin', 'Affiliation': 'Department of Psychology, Wayne State University, Detroit, Michigan, USA.'}, {'ForeName': 'Jessica R', 'Initials': 'JR', 'LastName': 'Beatty', 'Affiliation': 'Merrill Palmer Skillman Institute, Wayne State University, Detroit, Michigan, USA.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'McGoron', 'Affiliation': 'Merrill Palmer Skillman Institute, Wayne State University, Detroit, Michigan, USA.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Ondersma', 'Affiliation': 'Merrill Palmer Skillman Institute, Wayne State University, Detroit, Michigan, USA.'}]",Substance use & misuse,['10.1080/10826084.2020.1811343']
2546,32861841,Longitudinal trajectories of mood symptoms and global functioning in youth at high risk for bipolar disorder.,"BACKGROUND


Little is known about the longitudinal course of mood symptoms and functioning in youth who are at high risk for bipolar disorder (BD). Identifying distinct course trajectories and predictors of those trajectories may help refine treatment approaches.
METHODS


This study examined the longitudinal course of mood symptoms and functioning ratings in 126 youth at high risk for BD based on family history and early mood symptoms. Participants were enrolled in a randomized trial of family-focused therapy and followed longitudinally (mean 2.0 years, SD = 53.6 weeks).
RESULTS


Using latent class growth analyses (LCGA), we observed three mood trajectories. All youth started the study with active mood symptoms. Following the index mood episode, participants were classified as having a ""significantly improving course"" (n = 41, 32.5% of sample), a ""moderately symptomatic course"" (n = 21, 16.7%), or a ""predominantly symptomatic course"" (n = 64, 50.8%) at follow-up. More severe depression, anxiety, and suicidality at the study's baseline were associated with a poorer course of illness. LCGA also revealed three trajectories of global functioning that closely corresponded to symptom trajectories; however, fewer youth exhibited functional recovery than exhibited symptomatic recovery.
LIMITATIONS


Mood trajectories were assessed within the context of a treatment trial. Ratings of mood and functioning were based on retrospective recall.
CONCLUSIONS


This study suggests considerable heterogeneity in the course trajectories of youth at high risk for BD, with a significant proportion (32.5%) showing long-term remission of symptoms. Treatments that enhance psychosocial functioning may be just as important as those that ameliorate symptoms in youth at risk for BD.",2020,"More severe depression, anxiety, and suicidality at the study's baseline were associated with a poorer course of illness.","['126 youth at high risk for BD based on family history and early mood symptoms', 'youth at high risk for bipolar disorder', 'youth who are at high risk for bipolar disorder (BD']",['LCGA'],"['severe depression, anxiety, and suicidality']","[{'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0241889', 'cui_str': 'Family history of clinical finding'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0205275', 'cui_str': 'Latent'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0588008', 'cui_str': 'Severe depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.0524716,"More severe depression, anxiety, and suicidality at the study's baseline were associated with a poorer course of illness.","[{'ForeName': 'Marc J', 'Initials': 'MJ', 'LastName': 'Weintraub', 'Affiliation': 'Semel Institute of Neuroscience and Human Behavior, University of California, 760 Westwood Plaza, A7-370, Los Angeles 90095, CA, USA. Electronic address: mjweintraub@mednet.ucla.edu.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Schneck', 'Affiliation': 'School of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Patricia D', 'Initials': 'PD', 'LastName': 'Walshaw', 'Affiliation': 'Semel Institute of Neuroscience and Human Behavior, University of California, 760 Westwood Plaza, A7-370, Los Angeles 90095, CA, USA.'}, {'ForeName': 'Kiki D', 'Initials': 'KD', 'LastName': 'Chang', 'Affiliation': 'Private Practice, Menlo Park, CA, USA.'}, {'ForeName': 'Aimee E', 'Initials': 'AE', 'LastName': 'Sullivan', 'Affiliation': 'School of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Manpreet K', 'Initials': 'MK', 'LastName': 'Singh', 'Affiliation': 'School of Medicine, Stanford University, Palo Alto, CA, USA.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Miklowitz', 'Affiliation': 'Semel Institute of Neuroscience and Human Behavior, University of California, 760 Westwood Plaza, A7-370, Los Angeles 90095, CA, USA.'}]",Journal of affective disorders,['10.1016/j.jad.2020.08.018']
2547,32868037,"An Open-label, Single-dose Study to Evaluate the Pharmacokinetic Variables of Edaravone in Subjects with Mild, Moderate, or No Renal Impairment.","PURPOSE


The goal of this study was to compare edaravone pharmacokinetic (PK) variables and tolerability after a single intravenous (IV) infusion of 30 mg over 60 min in subjects with mild renal impairment (estimated glomerular filtration rate 60-89 mL/min/1.73 m 2 ), moderate renal impairment (30-59 mL/min/1.73 m 2 ), or normal renal function (≥90 mL/min/1.73 m 2 ).
METHODS


This open-label, single-dose study was conducted in Japan. After a screening period of up to 3 weeks, all subjects received a single IV dose of edaravone 30 mg/h on day 1. Blood samples were collected for PK analysis of edaravone and its sulfate conjugate for up to 48 h postdose.
FINDINGS


Edaravone was administered to 30 subjects: 11 with mild (Group 1), 8 with moderate (Group 2), and 11 with no (Group 3) renal impairment. Although geometric least-squares mean values for C max  and AUC 0-∞  for unchanged edaravone were 1.15- and 1.20-fold greater in Group 1 than in Group 3, and were 1.25- and 1.30-fold greater in Group 2 than in Group 3, no statistically significant differences in exposure (C max  and AUC) to edaravone were noted between the 3 groups (P > 0.05). The geometric least-squares mean values for C max  and AUC 0-∞  for the sulfate conjugate were 1.41- and 1.50-fold greater in Group 1 than in Group 3, and 1.41- and 1.97-fold greater in Group 2 than in Group 3. Differences in exposure (C max  and AUC) to the sulfate conjugate of edaravone were statistically significant between the 3 study groups (P < 0.0001). A total of 5 treatment-emergent adverse events in 3 subjects in Group 1 were considered by the investigator to be reasonably related to edaravone: headache (2 events/2 subjects), vomiting (2 events/1 subjects), and increased blood bilirubin level (n = 1). These treatment-emergent adverse events were mild and recovered without sequelae.
IMPLICATIONS


Mild to moderate renal impairment had no clinically significant effects on the PK profile of edaravone in Japanese subjects, relative to individuals with normal renal function, and there were no significant safety concerns. Thus, edaravone dosage adjustments are unlikely to be needed in patients with mild to moderate renal impairment. Clinicaltrials.gov identifier: NCT03289208.",2020,Differences in exposure (C max  and AUC) to the sulfate conjugate of edaravone were statistically significant between the 3 study groups (P < 0.0001).,"['patients with mild to moderate renal impairment', '30 subjects: 11 with mild (Group 1), 8 with moderate (Group 2), and 11 with no (Group 3) renal impairment', 'Subjects with Mild, Moderate, or No Renal Impairment', 'subjects with mild renal impairment (estimated glomerular filtration rate 60-89\xa0mL']",['edaravone 30'],"['blood bilirubin level', 'edaravone: headache', 'Differences in exposure (C max  and AUC', 'edaravone pharmacokinetic (PK) variables and tolerability', 'moderate renal impairment', 'PK profile of edaravone', 'exposure (C max  and AUC) to edaravone']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}]","[{'cui': 'C0070694', 'cui_str': 'edaravone'}]","[{'cui': 'C0863174', 'cui_str': 'Blood bilirubin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0070694', 'cui_str': 'edaravone'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}]",,0.029619,Differences in exposure (C max  and AUC) to the sulfate conjugate of edaravone were statistically significant between the 3 study groups (P < 0.0001).,"[{'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Nakamaru', 'Affiliation': 'Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan. Electronic address: nakamaru.yoshinobu@mf.mt-pharma.co.jp.'}, {'ForeName': 'Masae', 'Initials': 'M', 'LastName': 'Kakubari', 'Affiliation': 'Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan.'}, {'ForeName': 'Kaori', 'Initials': 'K', 'LastName': 'Yoshida', 'Affiliation': 'Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Akimoto', 'Affiliation': 'Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan.'}, {'ForeName': 'Kazuoki', 'Initials': 'K', 'LastName': 'Kondo', 'Affiliation': 'Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan.'}]",Clinical therapeutics,['10.1016/j.clinthera.2020.06.020']
2548,32851876,Variants of opioid genes and response to treatment of opioid use disorder with buprenorphine-naloxone versus extended-release naltrexone in Caucasians.,"Background : Sublingual buprenorphine-naloxone (BUP-NX), an FDA-approved treatment for opioid use disorder (OUD), combines buprenorphine (a partial mu/kappa agonist) with naloxone (a mu/ kappa antagonist). Extended-release injection naltrexone (XR-NTX; a mu receptor antagonist and kappa receptor partial agonist) is also an FDA-approved treatment for OUD. However, while some patients respond well to these medications, many others leave treatment and relapse.  Objectives : Determine whether gene variants in the opioid gene system are associated with better or worse treatment response.  Methods : In a 24-week, multisite, randomized, comparative effectiveness trial of daily, sublingual self-administration of BUP-NX versus monthly injection of XR-NTX conducted in the National Drug Abuse Clinical Trials Network, DNA was collected and four opioid gene variants were evaluated: (1) mu opioid receptor 118A>G; (2) 68-bp repeat in prodynorphin; (3) prodynorphin SNP rs910080; and (4) kappa opioid receptor SNP rs6473797. In non-Hispanic Caucasians ( N  = 334), two outcomes measures were assessed: received first dose (yes/no) and received last dose (yes/no). Separate logistic regressions were used to model each outcome measure as a function of treatment (XR-NTX vs BUP-NX), each gene variant, and their interaction.  Results : There were no significant main effects of gene variant on receiving first dose or last dose. There were also no significant gene variant by treatment interactions.  Conclusions : The outcome of treatment of OUD with medications is likely a complex function of multiple factors, including environmental, psychosocial, and possibly genetic, such that major effects of genetic variants may be unlikely.",2020,There were no significant main effects of gene variant on receiving first dose or last dose.,['Caucasians'],"['buprenorphine-naloxone (BUP-NX', 'naltrexone (XR-NTX', 'buprenorphine-naloxone', 'sublingual self-administration of BUP-NX versus monthly injection of XR-NTX', 'naloxone', 'buprenorphine']",[],"[{'cui': 'C0007457', 'cui_str': 'Caucasian'}]","[{'cui': 'C1169989', 'cui_str': 'Buprenorphine- and naloxone-containing product'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C0285526', 'cui_str': 'N-telopeptide'}, {'cui': 'C0001565', 'cui_str': 'Sublingual route'}, {'cui': 'C0036589', 'cui_str': 'Self-administration of medication'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0027358', 'cui_str': 'Naloxone'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}]",[],,0.0209085,There were no significant main effects of gene variant on receiving first dose or last dose.,"[{'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Randesi', 'Affiliation': 'Laboratory of the Biology of Addictive Diseases, the Rockefeller University , New York, NY, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Rotrosen', 'Affiliation': 'Department of Psychiatry, NYU Grossman School of Medicine , New York, NY, USA.'}, {'ForeName': 'Edward V', 'Initials': 'EV', 'LastName': 'Nunes', 'Affiliation': 'Department of Psychiatry, New York State Psychiatric Institute, Columbia University Medical Center , New York, NY, USA.'}, {'ForeName': 'Joshua D', 'Initials': 'JD', 'LastName': 'Lee', 'Affiliation': 'Department of Population Health, NYU Grossman School of Medicine , New York, NY, USA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Novo', 'Affiliation': 'Department of Psychiatry, NYU Grossman School of Medicine , New York, NY, USA.'}, {'ForeName': 'Orna', 'Initials': 'O', 'LastName': 'Levran', 'Affiliation': 'Laboratory of the Biology of Addictive Diseases, the Rockefeller University , New York, NY, USA.'}, {'ForeName': 'Jurg', 'Initials': 'J', 'LastName': 'Ott', 'Affiliation': 'Laboratory of Statistical Genetics, the Rockefeller University , New York, NY, USA.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Pavlicova', 'Affiliation': 'Department of Biostatistics, Columbia University Mailman School of Public Health , New York, NY, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Scodes', 'Affiliation': 'Division of Mental Health Data Science, New York State Psychiatric Institute , New York, NY, USA.'}, {'ForeName': 'Mary Jeanne', 'Initials': 'MJ', 'LastName': 'Kreek', 'Affiliation': 'Laboratory of the Biology of Addictive Diseases, the Rockefeller University , New York, NY, USA.'}]",The American journal of drug and alcohol abuse,['10.1080/00952990.2020.1797064']
2549,32868182,Early on-demand drainage versus standard management among acute necrotizing pancreatitis patients complicated by persistent organ failure: The protocol for an open-label multi-center randomized controlled trial.,"INTRODUCTION/AIM


Pancreatic necrosis occurs in a quarter of patients with acute pancreatitis, many of whom form an acute necrotic collection (ANC). The current standard treatment is to defer percutaneous catheter drainage (PCD) until the latter becomes ""walled off,"" which takes approximately four weeks. The majority of patients that develop persistent organ failure (POF), the primary determinant of mortality, do so within four weeks. To defer PCD until after four weeks may result in a worse outcome because of a missed opportunity to treat early infection and thereby reduce the severity and/or duration of POF. This study is aimed to compare the clinical outcome of the current standard approach with early on-demand PCD in acute necrotizing pancreatitis (ANP) patients with ANC and POF.
METHODS/DESIGN


This is an open-label, multi-center, parallel, randomized, controlled trial. All patients with ANP who develop POF during the first week of onset will be screened for eligibility. In total, 120 study subjects will be randomized to either early on-demand PCD or standard care. Patients assigned to the former will receive PCD when they show signs of decompensation like new-onset OF, aggravation of pre-existent OF, and persistent OF for more than a week. The primary composite endpoint is major complication and/or death. Patients will be followed until discharge or death with an additional follow-up 90 days after randomization.
DISCUSSION


This study challenges the standard 4-week delay before PCD and will answer the question whether early on-demand PCD is associated with a lower incidence of major complications and/or death.",2020,"Patients assigned to the former will receive PCD when they show signs of decompensation like new-onset OF, aggravation of pre-existent OF, and persistent OF for more than a week.","['patients with acute pancreatitis, many of whom form an acute necrotic collection (ANC', 'acute necrotizing pancreatitis patients complicated by persistent organ failure', 'acute necrotizing pancreatitis (ANP) patients with ANC and POF']","['demand drainage versus standard management', 'percutaneous catheter drainage (PCD']","['severity and/or duration of POF', 'major complication and/or death']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001339', 'cui_str': 'Acute pancreatitis'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0027540', 'cui_str': 'Necrosis'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C0030305', 'cui_str': 'Pancreatitis'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0349410', 'cui_str': 'Single organ dysfunction'}]","[{'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0349410', 'cui_str': 'Single organ dysfunction'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",120.0,0.120715,"Patients assigned to the former will receive PCD when they show signs of decompensation like new-onset OF, aggravation of pre-existent OF, and persistent OF for more than a week.","[{'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Qu', 'Affiliation': 'Center of Severe Acute Pancreatitis (CSAP), Department of Critical Care Medicine, Jinling Hospital, School of Medicine, Nanjing University, Nanjing, China.'}, {'ForeName': 'He', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Center of Severe Acute Pancreatitis (CSAP), Department of Critical Care Medicine, Jinling Hospital, School of Medicine, Nanjing University, Nanjing, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Chen', 'Affiliation': 'Tropical Clinical Trials Unit, Department of Clinical Sciences, Liverpool School of Tropical Medicine. Liverpool, L3 5QA, UK.'}, {'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Department of Gastroenterology, The First Affiliated Hospital of Nanchang University, Nanchang, China.'}, {'ForeName': 'Quanxing', 'Initials': 'Q', 'LastName': 'Feng', 'Affiliation': ""Xijing Hospital of Digestive Diseases, The Fourth Military Medical University，, Xi'an, China.""}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Guo', 'Affiliation': 'Department of Critical Care Medicine, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Zhiyong', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Department of Critical Care Medicine, Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Longxiang', 'Initials': 'L', 'LastName': 'Cao', 'Affiliation': 'Center of Severe Acute Pancreatitis (CSAP), Department of Critical Care Medicine, Jinling Hospital, School of Medicine, Nanjing University, Nanjing, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Center of Severe Acute Pancreatitis (CSAP), Department of Critical Care Medicine, Jinling Hospital, School of Medicine, Nanjing University, Nanjing, China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': 'Center of Severe Acute Pancreatitis (CSAP), Department of Critical Care Medicine, Jinling Hospital, School of Medicine, Nanjing University, Nanjing, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Ye', 'Affiliation': 'Center of Severe Acute Pancreatitis (CSAP), Department of Critical Care Medicine, Jinling Hospital, School of Medicine, Nanjing University, Nanjing, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Center of Severe Acute Pancreatitis (CSAP), Department of Critical Care Medicine, Jinling Hospital, School of Medicine, Nanjing University, Nanjing, China.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Ke', 'Affiliation': 'Center of Severe Acute Pancreatitis (CSAP), Department of Critical Care Medicine, Jinling Hospital, School of Medicine, Nanjing University, Nanjing, China. Electronic address: ctgchina@medbit.cn.'}, {'ForeName': 'Zhihui', 'Initials': 'Z', 'LastName': 'Tong', 'Affiliation': 'Center of Severe Acute Pancreatitis (CSAP), Department of Critical Care Medicine, Jinling Hospital, School of Medicine, Nanjing University, Nanjing, China. Electronic address: njzyantol@hotmail.com.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Windsor', 'Affiliation': 'HBP/Upper GI Unit, Department of General Surgery, Auckland City Hospital, Auckland, New Zealand; Surgical and Translational Research Centre, Faculty of Medical and Health Sciences, University of Auckland, New Zealand.'}, {'ForeName': 'Weiqin', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Center of Severe Acute Pancreatitis (CSAP), Department of Critical Care Medicine, Jinling Hospital, School of Medicine, Nanjing University, Nanjing, China.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Pancreatology : official journal of the International Association of Pancreatology (IAP) ... [et al.],['10.1016/j.pan.2020.08.012']
2550,32847776,Preoperative Duloxetine to improve acute pain and quality of recovery in patients undergoing modified radical mastectomy: A dose-ranging randomized controlled trial.,"OBJECTIVE


Duloxetine has been recently used as a part of multimodal analgesia in perioperative settings, yet the optimal dose of Duloxetine is not determined.
DESIGN


A parallel, randomized, placebo-controlled trial.
SETTING


Tertiary level oncology center.
PATIENTS


88 female patients with breast cancer were subjected to modified radical mastectomy (MRM) with ASA class I and II were recruited.
INTERVENTION


Participants were randomly allocated into 4 equal groups received 2 h preoperatively, placebo (D0, N = 22), Duloxetine 30 mg (D30, N = 22), Duloxetine 60 mg (D60, N = 22) and Duloxetine 90 mg (D90, N = 22) tablet.
MEASUREMENTS


The primary outcome; 24 h cumulative postoperative morphine consumption and the secondary outcomes; VAS score of pain intensity, quality of recovery (QoR-40), time to Aldrete 9, and side effects (sedation and vomiting) were measured.
RESULTS


The median (IQR) consumption of morphine (mg) in the first postoperative 24 h was significantly decreased in both (D60 and D90) groups compared to (D0 and D30) groups, P < 0.001(Bonferroni corrected), however, a non-significant reduction was observed between D90 group vs. D60 group and D30 group vs. D0 group, P = 0.595 and P = 0.462 respectively, D60 vs. D0; 0(0-6) vs. 10(9-12), D60 vs. D30; 0(0-6) vs. 9(8-11), D90 vs. D0; 0(0-5) vs. 10(9-12), D90 vs. D30; 0(0-5) vs. 9(8-11), D90 vs. D60; 0(0-5) vs. 0(0-6), D30 vs. D0; 9(8-11) vs. 10(9-12), patients in D90 group took longer time to recover from anesthesia "" time to Aldrete 9"" and showed an increased level of sedation in comparison with other groups, vomiting was more frequent in the D90 group.
CONCLUSION


Preoperative oral Duloxetine of 60 mg, for patients subjected to MRM is the optimal dose considering its analgesic efficacy and side effects.
TRIAL REGISTRATION


The trial was registered at Clinical Trials.gov with unique ID number; NCT03468348.",2020,"RESULTS


The median (IQR) consumption of morphine (mg) in the first postoperative 24 h was significantly decreased in both (D60 and D90) groups compared to (D0 and D30) groups, P < 0.001(Bonferroni corrected), however, a non-significant reduction was observed between D90 group vs. D60 group and D30 group vs. D0 group, P = 0.595 and P = 0.462 respectively, D60 vs. D0; 0(0-6) vs. 10(9-12), D60 vs. D30; 0(0-6) vs. 9(8-11), D90 vs. D0; 0(0-5) vs. 10(9-12), D90 vs. D30; 0(0-5) vs. 9(8-11), D90 vs. D60; 0(0-5) vs. 0(0-6), D30 vs. D0; 9(8-11) vs. 10(9-12), patients in D90 group took longer time to recover from anesthesia "" time to Aldrete 9"" and showed an increased level of sedation in comparison with other groups, vomiting was more frequent in the D90 group.
","['88 female patients with breast cancer', 'patients undergoing modified radical mastectomy', 'Tertiary level oncology center']","['Duloxetine', 'modified radical mastectomy (MRM) with ASA class', '2\xa0h preoperatively, placebo', 'Duloxetine 30\xa0mg (D30, N\xa0=\xa022), Duloxetine 60\xa0mg (D60, N\xa0=\xa022) and Duloxetine 90\xa0mg (D90, N\xa0=\xa022) tablet', 'placebo', 'morphine', 'Preoperative Duloxetine']","['level of sedation', 'analgesic efficacy and side effects', '24\xa0h cumulative postoperative morphine consumption and the secondary outcomes; VAS score of pain intensity, quality of recovery (QoR-40), time to Aldrete 9, and side effects (sedation and vomiting', 'vomiting', 'median (IQR) consumption', 'acute pain and quality of recovery']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0024883', 'cui_str': 'Modified radical mastectomy'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0245561', 'cui_str': 'duloxetine'}, {'cui': 'C0024883', 'cui_str': 'Modified radical mastectomy'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1616501', 'cui_str': 'duloxetine 30 MG [Cymbalta]'}, {'cui': 'C1667738', 'cui_str': 'duloxetine 60 MG'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0184567', 'cui_str': 'Acute pain'}]",88.0,0.273346,"RESULTS


The median (IQR) consumption of morphine (mg) in the first postoperative 24 h was significantly decreased in both (D60 and D90) groups compared to (D0 and D30) groups, P < 0.001(Bonferroni corrected), however, a non-significant reduction was observed between D90 group vs. D60 group and D30 group vs. D0 group, P = 0.595 and P = 0.462 respectively, D60 vs. D0; 0(0-6) vs. 10(9-12), D60 vs. D30; 0(0-6) vs. 9(8-11), D90 vs. D0; 0(0-5) vs. 10(9-12), D90 vs. D30; 0(0-5) vs. 9(8-11), D90 vs. D60; 0(0-5) vs. 0(0-6), D30 vs. D0; 9(8-11) vs. 10(9-12), patients in D90 group took longer time to recover from anesthesia "" time to Aldrete 9"" and showed an increased level of sedation in comparison with other groups, vomiting was more frequent in the D90 group.
","[{'ForeName': 'Diab Fuad', 'Initials': 'DF', 'LastName': 'Hetta', 'Affiliation': 'Department of Anesthesia and Pain Management, South Egypt Cancer Institute, Assiut University, Egypt.'}, {'ForeName': 'Nourhan Alaa', 'Initials': 'NA', 'LastName': 'Elgalaly', 'Affiliation': 'Department of Anesthesia and Pain Management, South Egypt Cancer Institute, Assiut University, Egypt.'}, {'ForeName': 'Helal F', 'Initials': 'HF', 'LastName': 'Hetta', 'Affiliation': 'Department of Internal Medicine, University of Cincinnati College of Medicine, Cincinnati, OH, USA; Department of Medical Microbiology and Immunology, Faculty of Medicine, Assiut University, Assiut, Egypt. Electronic address: Helal.hetta@uc.edu.'}, {'ForeName': 'Montaser A', 'Initials': 'MA', 'LastName': 'Fattah Mohammad', 'Affiliation': 'Department of Anesthesia and Pain Management, South Egypt Cancer Institute, Assiut University, Egypt.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.110007']
2551,32854339,A Novel Oral Syringe for Dosing and Administration of Multiparticulate Formulations: Acceptability Study in Preschool and School Children.,"The popularity of multiparticulate formulations (MPs) as a paediatric dosage form continues to increase. MPs comprise of multiple small units that are easy-to-swallow. Currently, MPs are commonly manufactured into unit doses that are either swallowed whole or opened prior to administration. While this is an acceptable approach, dosing is envisioned to be optimised with a ""standard"" paediatric device which can better harness the flexible dosing potential of MPs. We evaluated a novel oral syringe (Sympfiny TM , HS Design, Morristown, NJ, USA) that is being developed as a tool to dispense and administer MPs to children. Forty children, 4-12 years old, received 0.5, 1.2, and 2.0 mL doses of placebo MPs using the oral syringe with spring water or a drink of choice to complete sample intake. Acceptability was recorded as those able to completely swallow the dose and participants also rated dose acceptability on a 5-point scale. The ability to completely swallow the dose decreased as dose volume increased; the smallest dose was completely swallowed by 87.5% (35/40) children, and 69.4% (27/39) of children confirmed their willingness to take the sample as a daily medicine. Larger doses, 1.2 and 2.0 mL, gave values of 55% and 57.5% for the doses completely swallowed and 58.8% and 51.72% for willingness to take the sample as a daily medicine, respectively. Use of a drink of choice showed no increase in swallowability as compared with water. The novel oral syringe being developed is an appropriate device for dispensing doses flexibly and administering neutral tasting MPs directly to the mouth in the lower dose range without the need for a co-administration vehicle in children aged 4-12 years.",2020,Use of a drink of choice showed no increase in swallowability as compared with water.,"['children aged 4-12 years', 'Forty children, 4-12 years old, received 0.5, 1.2, and 2.0 mL doses of', 'Preschool and School Children']","['placebo MPs', 'novel oral syringe (Sympfiny TM , HS Design, Morristown, NJ, USA']","['swallowability', 'Acceptability']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C4068880', 'cui_str': '1.2'}, {'cui': 'C0260267', 'cui_str': 'School child'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0039142', 'cui_str': 'Syringe'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}]",40.0,0.0406445,Use of a drink of choice showed no increase in swallowability as compared with water.,"[{'ForeName': 'Justyna', 'Initials': 'J', 'LastName': 'Katarzyna Hofmanová', 'Affiliation': 'School of Pharmacy, Institute of Clinical Sciences, University of Birmingham, Birmingham B15 2TT, UK.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Bennett', 'Affiliation': 'Pfizer Global R&D, Sandwich, Kent CT13 9NJ, UK.'}, {'ForeName': 'Alastair', 'Initials': 'A', 'LastName': 'Coupe', 'Affiliation': 'Pfizer Global R&D, Sandwich, Kent CT13 9NJ, UK.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'A Bartlett', 'Affiliation': 'Pfizer Global R&D, Groton, CT 06340, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Monahan', 'Affiliation': 'Pfizer Global R&D, Groton, CT 06340, USA.'}, {'ForeName': 'Hannah Katharine', 'Initials': 'HK', 'LastName': 'Batchelor', 'Affiliation': 'Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, 161 Cathedral Street, Glasgow G4 0RE, UK.'}]",Pharmaceutics,['10.3390/pharmaceutics12090806']
2552,32856353,Stress management training program for stress reduction and coping improvement in public health nurses: A randomized controlled trial.,"AIMS


This study aimed to evaluate the effect of the stress management interventional program in reducing occupational stress and improving coping strategies among public health nurses.
DESIGN


A double-blind, cluster-randomized approach was used as a randomization method for this study to evaluate the stress management interventional program.
METHODS


A cluster-randomized controlled trial was carried out in eight comprehensive healthcare centres in Amman city, Jordan; four centres were randomly assigned to each experimental and control group. One hundred and seventy nurses were selected randomly from March 2019 - August 2019 and data were collected by using the Nursing Stress Scale & brief COPE over three data collection times. Both descriptive and inferential statistics (repeated measure ANOVA, Independent t test, and chi-squared) were used to answer the research questions of this study.
RESULTS


The results showed that both the levels of occupational stress and coping strategies were significantly different between the two study groups over the three data collection points (p < 0.05).
CONCLUSION


Based on the findings of this study, the stress management program is an effective non-invasive method that can be used to reduce stress levels and improve coping strategies for public health nurses. The implementation of stress management interventions in health care is likely to help nurses manage occupational stress in practice.
IMPACT


Nurses suffer from a high level of occupational stress. In particular, approximately74% of nurses experience severe occupational stress, which can lead to many mental and physical disorders. However, nurses were less able to utilize the correct stress preventive strategies due to gaps in knowledge, skills, and awareness. This study contributed to the provision of empirical evidence of the effectiveness of the stress management program in reducing occupational stress and improving coping strategies among public health nurses. A stress management intervention program is a valuable non-invasive method that can be used by healthcare organizations to reduce stress levels and improve coping strategies for nurses in practice.
CLINICAL TRIAL REGISTRATION NUMBER


NCT03833986.",2020,"A stress management intervention program is a valuable non-invasive method that can be used by healthcare organizations to reduce stress levels and improve coping strategies for nurses in practice.
","['public health nurses', 'One hundred and seventy nurses', 'eight comprehensive healthcare centres in Amman city, Jordan; four centres']","['stress management interventional program', 'stress management program', 'Stress management training program']","['levels of occupational stress and coping strategies', 'occupational stress']","[{'cui': 'C0034022', 'cui_str': 'Public health nurse'}, {'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0009586', 'cui_str': 'Comprehensive Healthcare'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0022418', 'cui_str': 'Jordan'}]","[{'cui': 'C0150788', 'cui_str': 'Stress management'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0814090', 'cui_str': 'Job-related Stress'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}]",8.0,0.0279992,"A stress management intervention program is a valuable non-invasive method that can be used by healthcare organizations to reduce stress levels and improve coping strategies for nurses in practice.
","[{'ForeName': ""Ja'far M"", 'Initials': 'JM', 'LastName': 'Alkhawaldeh', 'Affiliation': 'Faculty of Medicine and Health Sciences, Department of Nursing and Rehabilitation, University Putra Malaysia (UPM), Selangor, Malaysia.'}, {'ForeName': 'Kim Lam', 'Initials': 'KL', 'LastName': 'Soh', 'Affiliation': 'Faculty of Medicine and Health Sciences, Department of Nursing and Rehabilitation, University Putra Malaysia (UPM), Selangor, Malaysia.'}, {'ForeName': 'Firdaus', 'Initials': 'F', 'LastName': 'Mukhtar', 'Affiliation': 'Faculty of Medicines and Health Sciences, Department of Psychiatry, University Putra Malaysia (UPM), Selangor, Malaysia.'}, {'ForeName': 'Ooi Cheow', 'Initials': 'OC', 'LastName': 'Peng', 'Affiliation': 'Faculty of Medicines and Health Sciences, Department of Medicine, University Putra Malaysia (UPM), Selangor, Malaysia.'}, {'ForeName': 'Hamzeh M', 'Initials': 'HM', 'LastName': 'Alkhawaldeh', 'Affiliation': 'King Hussein Medical Center, Amman, Jordan.'}, {'ForeName': 'Rasmieh', 'Initials': 'R', 'LastName': 'Al-Amer', 'Affiliation': 'School of Nursing and Midwifery, Isra University/Western Sydney University, Amman, Jordan.'}, {'ForeName': 'Huda A', 'Initials': 'HA', 'LastName': 'Anshasi', 'Affiliation': 'School of Nursing, The University of Jordan, Amman, Jordan.'}]",Journal of advanced nursing,['10.1111/jan.14506']
2553,32857955,"Immediate impact of stay-at-home orders to control COVID-19 transmission on socioeconomic conditions, food insecurity, mental health, and intimate partner violence in Bangladeshi women and their families: an interrupted time series.","BACKGROUND


Stay-at-home orders (lockdowns) have been deployed globally to control COVID-19 transmission, and might impair economic conditions and mental health, and exacerbate risk of food insecurity and intimate partner violence. The effect of lockdowns in low-income and middle-income countries must be understood to ensure safe deployment of these interventions in less affluent settings. We aimed to determine the immediate impact of COVID-19 lockdown orders on women and their families in rural Bangladesh.
METHODS


An interrupted time series was used to compare data collected from families in Rupganj upazila, rural Bangladesh (randomly selected from participants in a randomised controlled trial), on income, food security, and mental health a median of 1 year and 2 years before the COVID-19 pandemic to data collected during the lockdown. We also assessed women's experiences of intimate partner violence during the pandemic.
RESULTS


Between May 19 and June 18, 2020, we randomly selected and invited the mothers of 3016 children to participate in the study, 2424 of whom provided consent. 2414 (99·9%, 95% CI 99·6-99·9) of 2417 mothers were aware of, and adhering to, the stay-at-home advice. 2321 (96·0%, 95·2-96·7) of 2417 mothers reported a reduction in paid work for the family. Median monthly family income fell from US$212 at baseline to $59 during lockdown, and the proportion of families earning less than $1·90 per day rose from five (0·2%, 0·0-0·5) of 2422 to 992 (47·3%, 45·2-49·5) of 2096 (p<0·0001 comparing baseline with lockdown period). Before the pandemic, 136 (5·6%, 4·7-6·6) of 2420 and 65 (2·7%, 2·1-3·4) of 2420 families experienced moderate and severe food insecurity, respectively. This increased to 881 (36·5%, 34·5-38·4) of 2417 and 371 (15·3%, 13·9-16·8) of 2417 during the lockdown; the number of families experiencing any level of food insecurity increased by 51·7% (48·1-55·4; p<0·0001). Mothers' depression and anxiety symptoms increased during the lockdown. Among women experiencing emotional or moderate physical violence, over half reported it had increased since the lockdown.
INTERPRETATION


COVID-19 lockdowns present significant economic, psychosocial, and physical risks to the wellbeing of women and their families across economic strata in rural Bangladesh. Beyond supporting only the most socioeconomically deprived, support is needed for all affected families.
FUNDING


National Health and Medical Research Council, Australia.",2020,"This increased to 881 (36·5%, 34·5-38·4) of 2417 and 371 (15·3%, 13·9-16·8) of 2417 during the lockdown; the number of families experiencing any level of food insecurity increased by 51·7% (48·1-55·4; p<0·0001).","['Bangladeshi women and their families', 'Between May 19 and June 18, 2020, we randomly selected and invited the mothers of 3016 children to participate in the study, 2424 of whom provided consent', ""women's experiences of intimate partner violence during the pandemic"", '2414', '2321', '2417 mothers', 'families in Rupganj upazila, rural Bangladesh (randomly selected from participants in a randomised controlled trial), on income, food security, and mental health a median of 1 year and 2 years before the COVID-19 pandemic to data collected during the lockdown', 'women and their families in rural Bangladesh', 'women experiencing emotional or moderate physical violence']",['lockdowns'],"['number of families experiencing any level of food insecurity', ""Mothers' depression and anxiety symptoms"", 'socioeconomic conditions, food insecurity, mental health, and intimate partner violence']","[{'cui': 'C0422784', 'cui_str': 'Bangladeshi'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C1615608', 'cui_str': 'Pandemics'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C3178753', 'cui_str': 'Food Security'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0476480', 'cui_str': 'Physical violence'}]",[],"[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C3494174', 'cui_str': 'Food insecurity'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0037464', 'cui_str': 'Factors, Socioeconomic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}]",3016.0,0.0664138,"This increased to 881 (36·5%, 34·5-38·4) of 2417 and 371 (15·3%, 13·9-16·8) of 2417 during the lockdown; the number of families experiencing any level of food insecurity increased by 51·7% (48·1-55·4; p<0·0001).","[{'ForeName': 'Jena Derakhshani', 'Initials': 'JD', 'LastName': 'Hamadani', 'Affiliation': 'International Center for Diarrhoeal Diseases Research, Dhaka, Bangladesh.'}, {'ForeName': 'Mohammed Imrul', 'Initials': 'MI', 'LastName': 'Hasan', 'Affiliation': 'International Center for Diarrhoeal Diseases Research, Dhaka, Bangladesh.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Baldi', 'Affiliation': 'Population Health and Immunity Division, The Walter and Eliza Hall Institute of Medical Research, Parkville, VIC, Australia; Department of Medical Biology, The University of Melbourne, Parkville, VIC, Australia.'}, {'ForeName': 'Sheikh Jamal', 'Initials': 'SJ', 'LastName': 'Hossain', 'Affiliation': 'International Center for Diarrhoeal Diseases Research, Dhaka, Bangladesh.'}, {'ForeName': 'Shamima', 'Initials': 'S', 'LastName': 'Shiraji', 'Affiliation': 'International Center for Diarrhoeal Diseases Research, Dhaka, Bangladesh.'}, {'ForeName': 'Mohammad Saiful Alam', 'Initials': 'MSA', 'LastName': 'Bhuiyan', 'Affiliation': 'International Center for Diarrhoeal Diseases Research, Dhaka, Bangladesh.'}, {'ForeName': 'Syeda Fardina', 'Initials': 'SF', 'LastName': 'Mehrin', 'Affiliation': 'International Center for Diarrhoeal Diseases Research, Dhaka, Bangladesh.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Fisher', 'Affiliation': 'Department of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Fahmida', 'Initials': 'F', 'LastName': 'Tofail', 'Affiliation': 'International Center for Diarrhoeal Diseases Research, Dhaka, Bangladesh.'}, {'ForeName': 'S M Mulk Uddin', 'Initials': 'SMMU', 'LastName': 'Tipu', 'Affiliation': 'International Center for Diarrhoeal Diseases Research, Dhaka, Bangladesh.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Grantham-McGregor', 'Affiliation': 'Institute of Child Health, University College London, London, UK.'}, {'ForeName': 'Beverley-Ann', 'Initials': 'BA', 'LastName': 'Biggs', 'Affiliation': 'Department of Medicine, Peter Doherty Institute, The University of Melbourne, Parkville, VIC, Australia; Victorian Infectious Diseases Service, Royal Melbourne Hospital, Parkville, VIC, Australia.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Braat', 'Affiliation': 'Department of Medicine, Peter Doherty Institute, The University of Melbourne, Parkville, VIC, Australia; School of Population and Global Health, The University of Melbourne, Parkville, VIC, Australia.'}, {'ForeName': 'Sant-Rayn', 'Initials': 'SR', 'LastName': 'Pasricha', 'Affiliation': 'Population Health and Immunity Division, The Walter and Eliza Hall Institute of Medical Research, Parkville, VIC, Australia; Department of Medical Biology, The University of Melbourne, Parkville, VIC, Australia; Diagnostic Haematology, Royal Melbourne Hospital, Parkville, VIC, Australia; Clinical Haematology at the Peter MacCallum Cancer Centre and Royal Melbourne Hospital, Parkville, VIC Australia. Electronic address: pasricha.s@wehi.edu.au.'}]",The Lancet. Global health,['10.1016/S2214-109X(20)30366-1']
2554,32858063,Dietary Nutrient Intake and Progression to Late Age-Related Macular Degeneration in the Age-Related Eye Disease Studies 1 and 2.,"PURPOSE


To analyze associations between the dietary intake of multiple nutrients and risk of progression to late age-related macular degeneration (AMD), its subtypes, and large drusen.
DESIGN


Post hoc analysis of 2 controlled clinical trial cohorts: Age-Related Eye Disease Study (AREDS) and AREDS2.
PARTICIPANTS


Eyes with no late AMD at baseline among AREDS participants (n = 4504) and AREDS2 participants (n = 3738) totaled 14 135 eyes. Mean age was 71.0 years (standard deviation, 6.7 years), and 56.5% of patients were women.
METHODS


Fundus photographs were collected at annual study visits and graded centrally for late AMD. Dietary intake of multiple nutrients was calculated from food frequency questionnaires.
MAIN OUTCOME MEASURES


Progression to late AMD, geographic atrophy (GA), neovascular AMD, and (separate analyses) large drusen.
RESULTS


Over median follow-up of 10.2 years, of the 14 135 eyes, 32.7% progressed to late AMD. For 9 nutrients, intake quintiles 4 or 5 (vs. 1) were associated significantly (P ≤ 0.0005) with decreased risk of late AMD: vitamin A, vitamin B6, vitamin C, folate, β-carotene, lutein and zeaxanthin, magnesium, copper, and alcohol. For 3 nutrients, quintiles 4 or 5 were associated significantly with increased risk: saturated fatty acid, monounsaturated fatty acid, and oleic acid. Similar results were observed for GA. Regarding neovascular AMD, 9 nutrients were associated nominally with decreased risk-vitamin A, vitamin B6, β-carotene, lutein and zeaxanthin, magnesium, copper, docosahexaenoic acid, omega-3 fatty acid, and alcohol-and 3 nutrients were associated with increased risk-saturated fatty acid, monounsaturated fatty acid, and oleic acid. In separate analyses (n = 5399 eyes of 3164 AREDS participants), 12 nutrients were associated nominally with decreased risk of large drusen.
CONCLUSIONS


Higher dietary intake of multiple nutrients, including minerals, vitamins, and carotenoids, is associated with decreased risk of progression to late AMD. These associations are stronger for GA than for neovascular AMD. The same nutrients also tend to show protective associations against large drusen development. Strong genetic interactions exist for some nutrient-genotype combinations, particularly omega-3 fatty acids and CFH. These data may justify further research into underlying mechanisms and randomized trials of supplementation.",2020,"For nine nutrients, intake quintiles 4 or 5 (versus 1) were significantly (P≤0.0005) associated with decreased risk of late AMD: vitamins A, B6, and C, folate, β-carotene, lutein/zeaxanthin, magnesium, copper, and alcohol.","['Mean age was 71.0 years (SD 6.7); 56.5% were female', 'two controlled clinical trial cohorts: Age-Related Eye Disease Study (AREDS; recruitment 1992-8) and AREDS2 (recruitment 2006-8', 'Eyes with no late AMD at baseline in AREDS participants (n=4,504) and AREDS2 participants (n=3,738): total of 14,135 eyes', 'Fundus photographs were collected at annual study visits and graded centrally for late AMD']",[],"['risk of large drusen', 'Progression to late AMD, geographic atrophy (GA), neovascular AMD, and (separate analyses) large drusen', 'risk (vitamins A and B6, β-carotene, lutein/zeaxanthin, magnesium, copper, docosahexaenoic acid, omega-3 fatty acid, and alcohol', 'risk: saturated fatty acid, monounsaturated fatty acid, and oleic acid', 'risk of late AMD: vitamins A, B6, and C, folate, β-carotene, lutein/zeaxanthin, magnesium, copper, and alcohol']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0936233', 'cui_str': 'Controlled Clinical Trial'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0015397', 'cui_str': 'Disorder of eye'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0456592', 'cui_str': '1992'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0242383', 'cui_str': 'Age related macular degeneration'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0016823', 'cui_str': 'Structure of fundus of eye'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0441800', 'cui_str': 'Grade'}]",[],"[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0035312', 'cui_str': 'Retinal drusen'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0242383', 'cui_str': 'Age related macular degeneration'}, {'cui': 'C1536085', 'cui_str': 'Dry Macular Degeneration'}, {'cui': 'C0271084', 'cui_str': 'Exudative age-related macular degeneration'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C0007269', 'cui_str': 'Carotene'}, {'cui': 'C2929534', 'cui_str': 'Lutein / zeaxanthin'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0009968', 'cui_str': 'Copper'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0597423', 'cui_str': 'Saturated fat'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0028928', 'cui_str': '9 cis-octadecenoic acid'}, {'cui': 'C0178638', 'cui_str': 'Folate'}]",9.0,0.0446104,"For nine nutrients, intake quintiles 4 or 5 (versus 1) were significantly (P≤0.0005) associated with decreased risk of late AMD: vitamins A, B6, and C, folate, β-carotene, lutein/zeaxanthin, magnesium, copper, and alcohol.","[{'ForeName': 'Elvira', 'Initials': 'E', 'LastName': 'Agrón', 'Affiliation': 'Division of Epidemiology and Clinical Applications, National Eye Institute, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Mares', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, School of Medicine and Public Health, University of Wisconsin, Madison, Wisconsin.'}, {'ForeName': 'Traci E', 'Initials': 'TE', 'LastName': 'Clemons', 'Affiliation': 'The Emmes Company LLC, Rockville, Maryland.'}, {'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Swaroop', 'Affiliation': 'Neurobiology-Neurodegeneration and Repair Laboratory, National Eye Institute, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Emily Y', 'Initials': 'EY', 'LastName': 'Chew', 'Affiliation': 'Division of Epidemiology and Clinical Applications, National Eye Institute, National Institutes of Health, Bethesda, Maryland. Electronic address: echew@nei.nih.gov.'}, {'ForeName': 'Tiarnan D L', 'Initials': 'TDL', 'LastName': 'Keenan', 'Affiliation': 'Division of Epidemiology and Clinical Applications, National Eye Institute, National Institutes of Health, Bethesda, Maryland. Electronic address: tiarnan.keenan@nih.gov.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Ophthalmology,['10.1016/j.ophtha.2020.08.018']
2555,32859118,Effects of the Preschool-Based Family-Involving DAGIS Intervention Program on Children's Energy Balance-Related Behaviors and Self-Regulation Skills: A Clustered Randomized Controlled Trial.,"The study examines the effects of a preschool-based family-involving multicomponent intervention on children's energy balance-related behaviors (EBRBs) such as food consumption, screen time and physical activity (PA), and self-regulation (SR) skills, and whether the intervention effects differed among children with low or high parental educational level (PEL) backgrounds. The Increased Health and Wellbeing in Preschools (DAGIS) intervention was conducted as a clustered randomized controlled trial, clustered at preschool level, over five months in 2017-2018. Altogether, 802 children aged 3-6 years in age participated. Parents reported children's consumption of sugary everyday foods and beverages, sugary treats, fruits, and vegetables by a food frequency questionnaire, and screen time by a 7-day diary. Physical activity was assessed by a hip-worn accelerometer. Cognitive and emotional SR was reported in a questionnaire by parents. General linear mixed models with and without repeated measures were used as statistical methods. At follow-up, no differences were detected in EBRBs or SR skills between the intervention and control group, nor did differences emerge in children's EBRBs between the intervention and the control groups when stratified by PEL. The improvement in cognitive SR skills among low PEL intervention children differed from low PEL control children, the significance being borderline. The DAGIS multicomponent intervention did not significantly affect children's EBRBs or SR. Further sub-analyses and a comprehensive process evaluation may shed light on the non-significant findings.",2020,"At follow-up, no differences were detected in EBRBs or SR skills between the intervention and control group, nor did differences emerge in children's EBRBs between the intervention and the control groups when stratified by PEL.","['802 children aged 3-6 years in age participated', 'children with low or high parental educational level (PEL) backgrounds']","['Preschool-Based Family-Involving DAGIS Intervention Program', 'preschool-based family-involving multicomponent intervention']","[""Children's Energy Balance-Related Behaviors and Self-Regulation Skills"", 'cognitive SR skills', 'Cognitive and emotional SR', 'Physical activity', 'EBRBs or SR skills', ""children's energy balance-related behaviors (EBRBs) such as food consumption, screen time and physical activity (PA), and self-regulation (SR) skills"", ""children's consumption of sugary everyday foods and beverages, sugary treats, fruits, and vegetables by a food frequency questionnaire, and screen time"", ""children's EBRBs"", ""children's EBRBs or SR""]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0442759', 'cui_str': '3/6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0013658', 'cui_str': 'Educational achievement'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C4704787', 'cui_str': 'Screen Time'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0524819', 'cui_str': 'Foods and drinks'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",802.0,0.028353,"At follow-up, no differences were detected in EBRBs or SR skills between the intervention and control group, nor did differences emerge in children's EBRBs between the intervention and the control groups when stratified by PEL.","[{'ForeName': 'Carola', 'Initials': 'C', 'LastName': 'Ray', 'Affiliation': 'Folkhälsan Research Center, Topeliuksenkatu 20, FI-00250 Helsinki, Finland.'}, {'ForeName': 'Rejane', 'Initials': 'R', 'LastName': 'Figuereido', 'Affiliation': 'Folkhälsan Research Center, Topeliuksenkatu 20, FI-00250 Helsinki, Finland.'}, {'ForeName': 'Henna', 'Initials': 'H', 'LastName': 'Vepsäläinen', 'Affiliation': 'Department of Food and Nutrition, University of Helsinki, P.O. Box 66, FI-00014 Helsinki, Finland.'}, {'ForeName': 'Reetta', 'Initials': 'R', 'LastName': 'Lehto', 'Affiliation': 'Folkhälsan Research Center, Topeliuksenkatu 20, FI-00250 Helsinki, Finland.'}, {'ForeName': 'Riikka', 'Initials': 'R', 'LastName': 'Pajulahti', 'Affiliation': 'Folkhälsan Research Center, Topeliuksenkatu 20, FI-00250 Helsinki, Finland.'}, {'ForeName': 'Essi', 'Initials': 'E', 'LastName': 'Skaffari', 'Affiliation': 'Folkhälsan Research Center, Topeliuksenkatu 20, FI-00250 Helsinki, Finland.'}, {'ForeName': 'Taina', 'Initials': 'T', 'LastName': 'Sainio', 'Affiliation': 'Folkhälsan Research Center, Topeliuksenkatu 20, FI-00250 Helsinki, Finland.'}, {'ForeName': 'Pauliina', 'Initials': 'P', 'LastName': 'Hiltunen', 'Affiliation': 'Folkhälsan Research Center, Topeliuksenkatu 20, FI-00250 Helsinki, Finland.'}, {'ForeName': 'Elviira', 'Initials': 'E', 'LastName': 'Lehto', 'Affiliation': 'Folkhälsan Research Center, Topeliuksenkatu 20, FI-00250 Helsinki, Finland.'}, {'ForeName': 'Liisa', 'Initials': 'L', 'LastName': 'Korkalo', 'Affiliation': 'Department of Food and Nutrition, University of Helsinki, P.O. Box 66, FI-00014 Helsinki, Finland.'}, {'ForeName': 'Katri', 'Initials': 'K', 'LastName': 'Sääksjärvi', 'Affiliation': 'Department of Teacher Education, University of Helsinki, P.O. Box 9, FI-00100 Helsinki, Finland.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Sajaniemi', 'Affiliation': 'Department of Teacher Education, University of Helsinki, P.O. Box 9, FI-00100 Helsinki, Finland.'}, {'ForeName': 'Maijaliisa', 'Initials': 'M', 'LastName': 'Erkkola', 'Affiliation': 'Department of Food and Nutrition, University of Helsinki, P.O. Box 66, FI-00014 Helsinki, Finland.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Roos', 'Affiliation': 'Folkhälsan Research Center, Topeliuksenkatu 20, FI-00250 Helsinki, Finland.'}]",Nutrients,['10.3390/nu12092599']
2556,32865010,Ischemic preconditioning prevents impact of prolonged sitting on glucose tolerance and markers of cardiovascular health but not cerebrovascular responses.,"Prolonged, uninterrupted sitting is demonstrated to acutely impair glucose homeostasis, but it also leads to detrimental cardiovascular health effects. We examined whether ischemic preconditioning (IPC) prevents the impact of prolonged sitting-induced glucose intolerance and measured related influencing factors such as (para)sympathetic nerve activity [assessed by heart rate variability (HRV)] and blood pressure during 2 h of prolonged sitting. In this randomized, controlled crossover study, 15 healthy participants (80% men) with a mean age of 21 ± 1 yr (means ± SD) and body mass index of 25.0 ± 2.4 kg/m 2  performed IPC (IPC, 4 × 5-min 220-mmHg unilateral occlusion at the thigh muscle) or a sham intervention (sham, 4 × 5 min 20-mmHg), followed by 2 h of sitting. After IPC or sham intervention, fingertip blood glucose was measured before and after 30, 60, 90, and 120 min of 75 g of glucose ingestions. Blood glucose responses during an oral glucose tolerance test were significantly attenuated, resulting in a lower area under the curve when sitting was preceded by a bout of IPC than sham ( P  < 0.05). IPC increased high-frequency oscillations and decreased the ratio of low-frequency-to-high-frequency oscillations at 120 min in HRV ( P  < 0.05). Moreover, a lower blood pressure was observed with IPC compared with sham ( P  < 0.05). Prolonged sitting or IPC did not affect cerebrovascular responses ( P  > 0.05). Collectively, these results indicate that the application of IPC before prolonged, uninterrupted sitting bout was associated with a better glucose tolerance and prevented impairment in (para)sympathetic nerve activity and blood pressure in healthy young men and women.",2020,Prolonged sitting or IPC did not affect cerebrovascular responses (P>0.05).,"['healthy young men and women', '15 healthy participants (80% men) with a mean age of 21±1 years (means±SD) and body mass index of 25.0±2.4 kg m 2  performed IPC (IPC']","['Prolonged sitting or IPC', 'Ischemic preconditioning', 'ischemic preconditioning (IPC']","['heart rate variability (HRV)) and blood pressure', 'cerebrovascular responses', 'IPC increased high-frequency oscillations', 'blood pressure', 'Blood glucose responses', 'glucose tolerance and markers of cardiovascular health', 'fingertip blood glucose']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1532718', 'cui_str': 'kg-m'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0376466', 'cui_str': 'Ischemic Pre-Conditioning'}]","[{'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0376466', 'cui_str': 'Ischemic Pre-Conditioning'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0376466', 'cui_str': 'Ischemic Pre-Conditioning'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C2718088', 'cui_str': 'High Frequency Oscillation Ventilation'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0729895', 'cui_str': 'Tip of finger'}]",15.0,0.0509521,Prolonged sitting or IPC did not affect cerebrovascular responses (P>0.05).,"[{'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Horiuchi', 'Affiliation': 'Division of Human Environmental Science, Mount Fuji Research Institute, Kamiyoshida, Fujiyoshida, Yamanashi, Japan.'}, {'ForeName': 'Dick H J', 'Initials': 'DHJ', 'LastName': 'Thijssen', 'Affiliation': 'Research Institute of Sport and Exercise Sciences, Liverpool John Moores University, Liverpool, United Kingdom.'}]",American journal of physiology. Endocrinology and metabolism,['10.1152/ajpendo.00302.2020']
2557,32861273,"Veliparib with carboplatin and paclitaxel in BRCA-mutated advanced breast cancer (BROCADE3): a randomised, double-blind, placebo-controlled, phase 3 trial.","BACKGROUND


BRCA1 or BRCA2-mutated breast cancers are sensitive to poly(ADP-ribose) polymerase (PARP) inhibitors and platinum agents owing to deficiency in homologous recombination repair of DNA damage. In this trial, we compared veliparib versus placebo in combination with carboplatin and paclitaxel, and continued as monotherapy if carboplatin and paclitaxel were discontinued before progression, in patients with HER2-negative advanced breast cancer and a germline BRCA1 or BRCA2 mutation.
METHODS


BROCADE3 was a randomised, double-blind, placebo-controlled, phase 3 trial done at 147 hospitals in 36 countries. Eligible patients (aged ≥18 years) had deleterious germline BRCA1 or BRCA2 mutation-associated, histologically or cytologically confirmed advanced HER2-negative breast cancer, an Eastern Cooperative Oncology Group performance status of 0-2, and had received up to two previous lines of chemotherapy for metastatic disease. Patients were randomly assigned (2:1) by interactive response technology by means of permuted blocks within strata (block size of 3 or 6) to carboplatin (area under the concentration curve 6 mg/mL per min intravenously) on day 1 and paclitaxel (80 mg/m 2  intravenously) on days 1, 8, and 15 of 21-day cycles combined with either veliparib (120 mg orally twice daily, on days -2 to 5) or matching placebo. If patients discontinued carboplatin and paclitaxel before progression, they could continue veliparib or placebo at an intensified dose (300 mg twice daily continuously, escalating to 400 mg twice daily if tolerated) until disease progression. Patients in the control group could receive open-label veliparib monotherapy after disease progression. Randomisation was stratified by previous platinum use, history of CNS metastases, and oestrogen and progesterone receptor status. The primary endpoint was investigator-assessed progression-free survival per Response Evaluation Criteria in Solid Tumors version 1.1. Efficacy analyses were done by intention to treat, which included all randomly assigned patients with a centrally confirmed BRCA mutation, and safety analyses included all patients who received at least one dose of velilparib or placebo. This study is ongoing and is registered with ClinicalTrials.gov, NCT02163694.
FINDINGS


Between July 30, 2014, and Jan 17, 2018, 2202 patients were screened, of whom 513 eligible patients were enrolled and randomly assigned. In the intention-to-treat population (n=509), 337 patients were assigned to receive veliparib plus carboplatin-paclitaxel (veliparib group) and 172 were assigned to receive placebo plus carboplatin-paclitaxel (control group). Median follow-up at data cutoff (April 5, 2019) was 35·7 months (IQR 24·9-43·6) in the veliparib group and 35·5 months (23·1-45·9) in the control group. Median progression-free survival was 14·5 months (95% CI 12·5-17·7) in the veliparib group versus 12·6 months (10·6-14·4) in the control group (hazard ratio 0·71 [95% CI 0·57-0·88], p=0·0016). The most common grade 3 or worse adverse events were neutropenia (272 [81%] of 336 patients in the veliparib group vs 143 [84%] of 171 patients in the control group), anaemia (142 [42%] vs 68 [40%]), and thrombocytopenia (134 [40%] vs 48 [28%]). Serious adverse events occurred in 115 (34%) patients in the veliparib group versus 49 (29%) patients in the control group. There were no study drug-related deaths.
INTERPRETATION


The addition of veliparib to a highly active platinum doublet, with continuation as monotherapy if the doublet were discontinued, resulted in significant and durable improvement in progression-free survival in patients with germline BRCA mutation-associated advanced breast cancer. These data indicate the utility of combining platinum and PARP inhibitors in this patient population.
FUNDING


AbbVie.",2020,Median progression-free survival was 14·5 months (95% CI 12·5-17·7) in the veliparib group versus 12·6 months (10·6-14·4) in the control group (hazard ratio 0·71,"['147 hospitals in 36 countries', 'BRCA-mutated advanced breast cancer (BROCADE3', 'Between July 30, 2014, and Jan 17, 2018, 2202 patients were screened, of whom 513 eligible patients were enrolled and randomly assigned', '337 patients', 'Eligible patients (aged ≥18 years) had deleterious germline BRCA1 or BRCA2 mutation-associated, histologically or cytologically confirmed advanced HER2-negative breast cancer, an Eastern Cooperative Oncology Group performance status of 0-2, and had received up to two previous lines of chemotherapy for metastatic disease', 'patients with HER2-negative advanced breast cancer and a germline BRCA1 or BRCA2 mutation', 'patients with germline BRCA mutation-associated advanced breast cancer']","['carboplatin and paclitaxel', 'Veliparib with carboplatin and paclitaxel', 'open-label veliparib monotherapy', 'veliparib versus placebo', 'placebo', 'velilparib or placebo', 'veliparib plus carboplatin-paclitaxel (veliparib group', 'veliparib', 'placebo plus carboplatin-paclitaxel (control group', 'platinum and PARP inhibitors', 'interactive response technology by means of permuted blocks within strata (block size of 3 or 6) to carboplatin (area under the concentration curve 6 mg/mL per min intravenously) on day 1 and paclitaxel']","['thrombocytopenia', 'Serious adverse events', 'neutropenia', 'anaemia', 'progression-free survival', 'investigator-assessed progression-free survival per Response Evaluation Criteria', 'Median progression-free survival']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1528558', 'cui_str': 'BRCA1 protein, human'}, {'cui': 'C1511024', 'cui_str': 'BRCA2 gene mutation'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C4087376', 'cui_str': 'HER2 negative'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}]","[{'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C1958300', 'cui_str': 'veliparib'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C1882413', 'cui_str': 'Nicotinamide adenine dinucleotide adenosine diphosphate ribosyltransferase inhibitor-containing product'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0439294', 'cui_str': 'g/L'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",2202.0,0.566861,Median progression-free survival was 14·5 months (95% CI 12·5-17·7) in the veliparib group versus 12·6 months (10·6-14·4) in the control group (hazard ratio 0·71,"[{'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Diéras', 'Affiliation': 'Institut Curie, Paris, France; Breast Oncology, Centre Eugène Marquis, Rennes, France. Electronic address: v.dieras@rennes.unicancer.fr.'}, {'ForeName': 'Hyo S', 'Initials': 'HS', 'LastName': 'Han', 'Affiliation': 'Moffitt Cancer Center, Tampa, FL, USA.'}, {'ForeName': 'Bella', 'Initials': 'B', 'LastName': 'Kaufman', 'Affiliation': 'Tel-Aviv University, Sheba Medical Center, Tel Hashomer, Ramat Gan, Israel.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Wildiers', 'Affiliation': 'Department of General Medical Oncology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Friedlander', 'Affiliation': 'Prince of Wales Clinical School UNSW and Prince of Wales Hospital, Sydney, NSW, Australia.'}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Ayoub', 'Affiliation': ""Centre Hospitalier de l'Université de Montréal, Montreal, QC, Canada.""}, {'ForeName': 'Shannon L', 'Initials': 'SL', 'LastName': 'Puhalla', 'Affiliation': 'UPMC Cancer Centers, Pittsburgh, PA, USA.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Bondarenko', 'Affiliation': 'Dnipropetrovsk Medical Academy, City Clinical Hospital Number 4, Dnipro, Ukraine.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Campone', 'Affiliation': ""Institut de Cancérologie de l'Ouest Saint-Herblain, France.""}, {'ForeName': 'Erik H', 'Initials': 'EH', 'LastName': 'Jakobsen', 'Affiliation': 'Vejle Hospital/Lillebaelt Hospital, Vejle, Denmark.'}, {'ForeName': 'Mathilde', 'Initials': 'M', 'LastName': 'Jalving', 'Affiliation': 'University Medical Center Groningen, University of Groningen, Groningen, Netherlands.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Oprean', 'Affiliation': 'University of Medicine and Pharmacy Timisoara and Oncomed SRL, Timisoara, Romania.'}, {'ForeName': 'Marketa', 'Initials': 'M', 'LastName': 'Palácová', 'Affiliation': 'Masaryk Memorial Cancer Institute, Brno, Czech Republic.'}, {'ForeName': 'Yeon Hee', 'Initials': 'YH', 'LastName': 'Park', 'Affiliation': 'Samsung Medical Center, Seoul, South Korea.'}, {'ForeName': 'Yaroslav', 'Initials': 'Y', 'LastName': 'Shparyk', 'Affiliation': 'Lviv State Regional Treatment and Diagnostic Oncology Center, Lviv, Ukraine.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Yañez', 'Affiliation': 'Universidad de la Frontera, Temuco, Chile.'}, {'ForeName': 'Nikhil', 'Initials': 'N', 'LastName': 'Khandelwal', 'Affiliation': 'AbbVie, North Chicago, IL, USA.'}, {'ForeName': 'Madan G', 'Initials': 'MG', 'LastName': 'Kundu', 'Affiliation': 'AbbVie, North Chicago, IL, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Dudley', 'Affiliation': 'AbbVie, North Chicago, IL, USA.'}, {'ForeName': 'Christine K', 'Initials': 'CK', 'LastName': 'Ratajczak', 'Affiliation': 'AbbVie, North Chicago, IL, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Maag', 'Affiliation': 'AbbVie, North Chicago, IL, USA.'}, {'ForeName': 'Banu K', 'Initials': 'BK', 'LastName': 'Arun', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30447-2']
2558,32867199,Omega-3 Polyunsaturated Fatty Acids EPA and DHA as an Adjunct to Non-Surgical Treatment of Periodontitis: A Randomized Clinical Trial.,"Periodontitis is a chronic multifactorial inflammatory disease that leads to the loss of supportive tissues around the teeth with gradual deterioration of masticatory function and esthetics, resulting eventually in the decrease of the life quality. Host immune response triggered by bacterial biofilm is responsible for the chronic periodontal inflammation and ongoing tissue loss. Omega-3 polyunsaturated fatty acids (PUFA) such as eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) have anti-inflammatory properties, thus may be used for the treatment of chronic inflammatory diseases. In this study, we aimed to evaluate the effect of dietary supplementation with omega-3 PUFA in the patients with stage III and IV periodontitis. Thirty otherwise healthy patients were treated with scaling and root planning (SRP). In the test group ( n  = 16), patients were additionally supplemented with 2.6 g of EPA and 1.8 g of DHA. In the control group ( n  = 14), patients received only SRP. Periodontal examination was performed at baseline and three months following initial therapy. Salivary samples were taken twice at baseline and at the end of the experiment. We found that there was a statistically significant reduction in the bleeding on probing (BOP) and improvement of clinical attachment loss (CAL) at three months in the test group compared to the control group. Moreover, a statistically significant higher percentage of closed pockets (probing depth ≤ 4 mm without BOP) was achieved in the test group vs. control group after three months of treatment. Accordingly, the levels of pro-inflammatory cytokines/chemokines interleukin (IL)-8 and IL-17 were markedly lower, while the level of anti-inflammatory IL-10 was significantly higher in the salivary samples of the patients supplemented with omega-3 PUFA at three months in comparison to the patients treated with SRP alone. Our findings demonstrate that dietary intervention with high-dose of omega-3 PUFA during non-surgical therapy may have potential benefits in the management of periodontitis.",2020,"Moreover, a statistically significant higher percentage of closed pockets (probing depth ≤ 4 mm without BOP) was achieved in the test group vs. control group after three months of treatment.","['Periodontitis', 'Thirty otherwise healthy patients', 'patients with stage III and IV periodontitis']","['dietary supplementation with omega-3 PUFA', 'scaling and root planning (SRP', 'omega-3 PUFA', 'Omega-3 Polyunsaturated Fatty Acids EPA and DHA', 'Omega-3 polyunsaturated fatty acids (PUFA) such as eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA']","['level of anti-inflammatory IL-10', 'closed pockets', 'levels of pro-inflammatory cytokines/chemokines interleukin (IL)-8 and IL-17', 'bleeding on probing (BOP) and improvement of clinical attachment loss (CAL']","[{'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}]","[{'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0282554', 'cui_str': 'Cytokines, Chemotactic'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0384648', 'cui_str': 'Interleukin 17'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0439259', 'cui_str': 'kcal'}]",30.0,0.0340405,"Moreover, a statistically significant higher percentage of closed pockets (probing depth ≤ 4 mm without BOP) was achieved in the test group vs. control group after three months of treatment.","[{'ForeName': 'Mirella', 'Initials': 'M', 'LastName': 'Stańdo', 'Affiliation': 'Department of Periodontology and Oral Diseases, Medical University of Lodz, 90-419 Lodz, Poland.'}, {'ForeName': 'Paweł', 'Initials': 'P', 'LastName': 'Piatek', 'Affiliation': 'Department of Neurology, Medical University of Lodz, 90-419 Lodz, Poland.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Namiecinska', 'Affiliation': 'Department of Neurology, Medical University of Lodz, 90-419 Lodz, Poland.'}, {'ForeName': 'Przemysław', 'Initials': 'P', 'LastName': 'Lewkowicz', 'Affiliation': 'Department of Neurology, Medical University of Lodz, 90-419 Lodz, Poland.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Lewkowicz', 'Affiliation': 'Department of Periodontology and Oral Diseases, Medical University of Lodz, 90-419 Lodz, Poland.'}]",Nutrients,['10.3390/nu12092614']
2559,32867251,A Prospective Randomized Study: The Usefulness and Efficacy of Negative Pressure Wound Therapy with Lipidocolloid Polyester Mesh Compared to Traditional Negative Pressure Wound Therapy for Treatment of Pressure Ulcers.,"To improve healing of pressure ulcer wounds, it is important to optimize the conditions of the area surrounding the wound. Negative pressure wound therapy (NPWT) promotes wound healing, however, the removal of NPWT can cause pain or focal bleeding, delaying wound healing or causing infection. In this study, we reviewed the efficacy of the lipidocolloid non-adherent dressing (Urgotul ® ) as a wound contact layer. A total of 38 patients from the same facility who applied NPWT from April 2016 to October 2019 were included and divided into two groups; NPWT with the lipidocolloid non-adherent dressing (group 1, experimental group, 19 patients) and NPWT only (group 2, control group, 19 patients). The condition of the wound was examined prior to NPWT application, at one week, and again at three weeks after application. No significant differences were found between groups for general characteristics, bacterial culture or photo analysis. However, when comparing groups based on the time of examination, there was a significant reduction of the wound size in group 1 ( p  = 0.001) but not in group 2 ( p  = 0.082). Therefore, the current study finds that using the lipidocolloid non-adherent dressing as a wound contact layer in NPWT stimulates healing by shrinking the size of the pressure ulcer wound.",2020,"No significant differences were found between groups for general characteristics, bacterial culture or photo analysis.",['38 patients from the same facility who applied NPWT from April 2016 to October 2019'],"['Negative pressure wound therapy (NPWT', 'Negative Pressure Wound Therapy with Lipidocolloid Polyester Mesh', 'NPWT', 'lipidocolloid non-adherent dressing (Urgotul ® ', 'lipidocolloid non-adherent dressing', 'Traditional Negative Pressure Wound Therapy']","['general characteristics, bacterial culture or photo analysis', 'wound size']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C1956078', 'cui_str': 'Topical Negative-Pressure Therapy'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C1956078', 'cui_str': 'Topical Negative-Pressure Therapy'}, {'cui': 'C0127612', 'cui_str': 'Polyester mesh'}, {'cui': 'C0180524', 'cui_str': 'Non-adherent dressing'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0430402', 'cui_str': 'Bacterial culture'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0456389', 'cui_str': 'Size'}]",38.0,0.0101903,"No significant differences were found between groups for general characteristics, bacterial culture or photo analysis.","[{'ForeName': 'Wooyeol', 'Initials': 'W', 'LastName': 'Baek', 'Affiliation': 'Institute for Human Tissue Restoration, Department of Plastic & Reconstructive Surgery, Severance Hospital, Yonsei University College of Medicine, Seoul 03722, Korea.'}, {'ForeName': 'Nara', 'Initials': 'N', 'LastName': 'Lee', 'Affiliation': 'Institute for Human Tissue Restoration, Department of Plastic & Reconstructive Surgery, Severance Hospital, Yonsei University College of Medicine, Seoul 03722, Korea.'}, {'ForeName': 'Eun Jin', 'Initials': 'EJ', 'LastName': 'Han', 'Affiliation': 'Certified Wound Care Nurse (CWCN), Certified Foot Care Nurse (CFCN), Nurse Department, Severance Hospital, Seoul 03722, Korea.'}, {'ForeName': 'Tai Suk', 'Initials': 'TS', 'LastName': 'Roh', 'Affiliation': 'Institute for Human Tissue Restoration, Department of Plastic & Reconstructive Surgery, Severance Hospital, Yonsei University College of Medicine, Seoul 03722, Korea.'}, {'ForeName': 'Won Jai', 'Initials': 'WJ', 'LastName': 'Lee', 'Affiliation': 'Institute for Human Tissue Restoration, Department of Plastic & Reconstructive Surgery, Severance Hospital, Yonsei University College of Medicine, Seoul 03722, Korea.'}]",Pharmaceutics,['10.3390/pharmaceutics12090813']
2560,32867282,"The Effect of Dietary Supplementation on Aggressive Behaviour in Australian Adult Male Prisoners: A Feasibility and Pilot Study for a Randomised, Double Blind Placebo Controlled Trial.","This study aimed to assess the feasibility of conducting a nutrition trial in adult male prisoners. Adult male prisoners were recruited for a 16-week randomised control trial comparing the effect of ingestion of omega-3 long chain polyunsaturated fatty acids (n-3 LCPUFA) and multivitamin supplements versus placebo on aggressive behaviour. The baseline and post-intervention assessments from the participant blood samples were the erythrocyte n-3 LCPUFA levels as well as measures of aggressive behaviour determined through institutional records of misconduct (IRM), the Inmate Behaviour Observation Scale (IBOS), and questionnaires. A total of 136 adult male prisoners consented to the study with a retention rate of 60%, and 93% of blood samples were successfully collected. The IRM and IBOS scores were collected for 100% of participants, whilst 82-97% of participants completed the questionnaires. From the baseline data, the Odds Ratio shows that prisoners are 4.3 times more likely to have an IBOS >2 if they are below the 6% cut off on the omega-3 index. Both groups improved across all outcome measures and, at the current sample size, no significant differences were seen between them. A power calculation suggests a total sample size of 600 participants is required to detect the effects of this dietary supplementation, and that this supplementation study is feasible in a Correctional Centre. Important criteria for the exclusion and consideration of logistics and compliance are presented.",2020,"Both groups improved across all outcome measures and, at the current sample size, no significant differences were seen between them.","['adult male prisoners', '600 participants', 'Adult male prisoners', 'Australian Adult Male Prisoners', '136 adult male prisoners consented to the study with a retention rate of 60%, and 93% of blood samples were successfully collected']","['Dietary Supplementation', 'Placebo', 'ingestion of omega-3 long chain polyunsaturated fatty acids (n-3 LCPUFA) and multivitamin supplements versus placebo']","['erythrocyte n-3 LCPUFA levels', 'IRM and IBOS scores', 'Aggressive Behaviour', 'aggressive behaviour determined through institutional records of misconduct (IRM), the Inmate Behaviour Observation Scale (IBOS), and questionnaires']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0033167', 'cui_str': 'Prisoners'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}]","[{'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0301532', 'cui_str': 'Multivitamin preparation'}]","[{'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2355580', 'cui_str': 'Record of'}, {'cui': 'C0033167', 'cui_str': 'Prisoners'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",136.0,0.338338,"Both groups improved across all outcome measures and, at the current sample size, no significant differences were seen between them.","[{'ForeName': 'Colin H', 'Initials': 'CH', 'LastName': 'Cortie', 'Affiliation': 'School of Medicine, Lipid Research Centre, Molecular Horizons, University of Wollongong, Wollongong, NSW 2522, Australia.'}, {'ForeName': 'Mitchell K', 'Initials': 'MK', 'LastName': 'Byrne', 'Affiliation': 'School of Psychology, University of Wollongong, Wollongong, NSW 2522, Australia.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Collier', 'Affiliation': 'South Coast Correctional Centre, Nowra, NSW 2541; Australia.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Parletta', 'Affiliation': 'Allied Health & Human Performance, University of South Australia, Adelaide, SA 5001, Australia.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Crawford', 'Affiliation': 'South Coast Correctional Centre, Nowra, NSW 2541; Australia.'}, {'ForeName': 'Pia C', 'Initials': 'PC', 'LastName': 'Winberg', 'Affiliation': 'Venus Shell Systems and Shoalhaven Marine & Freshwater Centre, University of Wollongong, Nowra, NSW 2541, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Webster', 'Affiliation': 'School of Medicine, Lipid Research Centre, Molecular Horizons, University of Wollongong, Wollongong, NSW 2522, Australia.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Chapman', 'Affiliation': 'South Coast Correctional Centre, Nowra, NSW 2541; Australia.'}, {'ForeName': 'Gayle', 'Initials': 'G', 'LastName': 'Thomas', 'Affiliation': 'South Coast Correctional Centre, Nowra, NSW 2541; Australia.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Dally', 'Affiliation': 'South Coast Correctional Centre, Nowra, NSW 2541; Australia.'}, {'ForeName': 'Marijka', 'Initials': 'M', 'LastName': 'Batterham', 'Affiliation': 'Statistical Consulting Service, University of Wollongong, Wollongong, NSW 2522, Australia.'}, {'ForeName': 'Anne Marie', 'Initials': 'AM', 'LastName': 'Martin', 'Affiliation': 'Corrective Services New South Wales, Sydney, NSW 2000, Australia.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Grant', 'Affiliation': 'Corrective Services New South Wales, Sydney, NSW 2000, Australia.'}, {'ForeName': 'Barbara J', 'Initials': 'BJ', 'LastName': 'Meyer', 'Affiliation': 'School of Medicine, Lipid Research Centre, Molecular Horizons, University of Wollongong, Wollongong, NSW 2522, Australia.'}]",Nutrients,['10.3390/nu12092617']
2561,32866688,Improved neck posture and reduced neck muscle activity when using a novel camera based workstation for manual precision inspection tasks.,"PURPOSE


This study investigates the effects of the usage of a novel camera system compared to a conventional lens system for manual precision tasks. Utilizing the novel camera system aims to improve neck posture, reduce neck muscle tension and thereby minimize the risk of neck pain.
METHODS


Camera and lens systems were compared by assessing the craniovertebral angle (CVA), electromyographic activity of the M.trapezius and perceived exertion. 16 healthy participants (n = 8 female, 24 ± 2 years; n = 8 male, 30 ± 5 years) performed manual precision tasks in a cross-over design using both systems in sitting and standing positions.
RESULTS


Analyses showed that using the camera system improved the CVA in sitting [28.4° (22.8°-33.9°) to 42.5° (38.9°-46.1°); p < 0.01] and decreased the M.trapezius activity in standing [13.1% (7.7%-18.6%) to 8.65% (5.49%-11.81%)]. Additionally, overall and neck specific perceived exertion decreased when using the camera system in standing.
CONCLUSIONS


The camera system may prevent neck pain in workers performing manual precision tasks in sitting and standing postures.",2020,"Utilizing the novel camera system aims to improve neck posture, reduce neck muscle tension and thereby minimize the risk of neck pain.
","['16 healthy participants (n\xa0=\xa08 female, 24\xa0±\xa02 years; n\xa0=\xa08 male, 30\xa0±\xa05 years) performed']","['manual precision tasks in a cross-over design using both systems in sitting and standing positions', 'novel camera system']","['craniovertebral angle (CVA), electromyographic activity of the M.trapezius and perceived exertion', 'CVA in sitting', 'Improved neck posture and reduced neck muscle activity', 'M.trapezius activity', 'overall and neck specific perceived exertion']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0242817', 'cui_str': 'Crossover Design'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0179533', 'cui_str': 'Camera'}]","[{'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C0027532', 'cui_str': 'Skeletal muscle structure of neck'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205369', 'cui_str': 'Specific'}]",16.0,0.0296013,"Utilizing the novel camera system aims to improve neck posture, reduce neck muscle tension and thereby minimize the risk of neck pain.
","[{'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Gräf', 'Affiliation': 'Department of Human Movement Science, University of Hamburg, Mollerstraße 10, 20148, Hamburg, Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Mattes', 'Affiliation': 'Department of Human Movement Science, University of Hamburg, Mollerstraße 10, 20148, Hamburg, Germany.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Luedtke', 'Affiliation': 'Department of Human Movement Science, University of Hamburg, Mollerstraße 10, 20148, Hamburg, Germany; Department of Health Sciences, Academic Physiotherapy, Pain and Exercise Research Luebeck (P.E.R.L), University of Luebeck, Luebeck, Germany.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Wollesen', 'Affiliation': 'Department of Human Movement Science, University of Hamburg, Mollerstraße 10, 20148, Hamburg, Germany; Department of Psychology and Neuroergonomics, Technical University of Berlin, Fasanenstraße 1, 10623, Berlin, Germany. Electronic address: bettina.wollesen@uni-hamburg.de.'}]",Applied ergonomics,['10.1016/j.apergo.2020.103147']
2562,32867047,The Effect of Vinegar Supplementation on High-Intensity Cycling Performance within Recreationally Trained Individuals.,"Background and objectives : To investigate the effects of vinegar ingestion upon high-intensity cycle performance in recreationally trained individuals.  Materials and methods : Twenty-two participants consumed one of the following in a randomized order on four separate visits: (1) 29 mL of vinegar along with 451 mL of water, (2) 39 g of sucrose along with 441 mL of water, (3) 29 mL of vinegar and 39 g of sucrose along with 412 mL of water, or (4) 480 mL of water alone. For each of the experimental testing sessions, all participants completed in order: (1) high-intensity cycle test 1, (2) fatiguing cycle test, (3) high-intensity cycle test 2, (4) supplement consumption, (5) 90 min rest period, and (6) high-intensity cycle test 3. Total time to exhaustion (TTE) and average heart rate (HR) for each set of sprints was used in analysis.  Results : There was no supplement by time interaction or significant main treatment effect observed ( p  > 0.05) for either TTE or HR. However, there was a main time effect observed, with TTE ( p  = 0.0001) being lower for cycle test 2 than both cycle test 1 and cycle test 3, and cycle test 3 being lower than cycle test 1. HR ( p  = 0.0001) was lower for cycle test 3 than both cycle test 1 and cycle test 2, but HR for cycle test 1 did not differ significantly from HR for cycle test 2.  Conclusions : The addition of vinegar or sucrose alone, or in combination, was ineffective in improving cycle sprinting TTE when performing three cycle tests.",2020,"HR ( p  = 0.0001) was lower for cycle test 3 than both cycle test 1 and cycle test 2, but HR for cycle test 1 did not differ significantly from HR for cycle test 2.  ","['recreationally trained individuals', 'Recreationally Trained Individuals']","['29 mL of vinegar along with 451 mL of water, (2) 39 g of sucrose along with 441 mL of water, (3) 29 mL of vinegar and 39 g of sucrose along with 412 mL of water, or (4) 480 mL of water alone', 'vinegar ingestion', 'Vinegar Supplementation', 'vinegar or sucrose alone']","['Total time to exhaustion (TTE) and average heart rate (HR', 'High-Intensity Cycling Performance']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0148405', 'cui_str': 'Vinegar'}, {'cui': 'C5191282', 'cui_str': '451'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}, {'cui': 'C4319609', 'cui_str': '480'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}]",22.0,0.126151,"HR ( p  = 0.0001) was lower for cycle test 3 than both cycle test 1 and cycle test 2, but HR for cycle test 1 did not differ significantly from HR for cycle test 2.  ","[{'ForeName': 'Tyler M', 'Initials': 'TM', 'LastName': 'Farney', 'Affiliation': 'Human Performance Laboratory, Department of Health & Kinesiology, Texas A&M University-Kingsville, Kingsville, TX 78363, USA.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Kowalsky', 'Affiliation': 'Human Performance Laboratory, Department of Health & Kinesiology, Texas A&M University-Kingsville, Kingsville, TX 78363, USA.'}, {'ForeName': 'Dassy A', 'Initials': 'DA', 'LastName': 'Salazar', 'Affiliation': 'Human Performance Laboratory, Department of Health & Kinesiology, Texas A&M University-Kingsville, Kingsville, TX 78363, USA.'}, {'ForeName': 'Alyssa N', 'Initials': 'AN', 'LastName': 'Fick', 'Affiliation': 'Human Performance Laboratory, Department of Health & Kinesiology, Texas A&M University-Kingsville, Kingsville, TX 78363, USA.'}, {'ForeName': 'Arnold G', 'Initials': 'AG', 'LastName': 'Nelson', 'Affiliation': 'Exercise Biochemistry Laboratory, School of Kinesiology, Louisiana State University, Baton Rouge, LA 70803, USA.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Hearon', 'Affiliation': 'Human Performance Laboratory, Department of Health & Kinesiology, Texas A&M University-Kingsville, Kingsville, TX 78363, USA.'}]","Medicina (Kaunas, Lithuania)",['10.3390/medicina56090429']
2563,32867053,Seasonal Antimicrobial Activity of the Airway: Post-Hoc Analysis of a Randomized Placebo-Controlled Double-Blind Trial.,"BACKGROUND


It is widely unknown why respiratory infections follow a seasonal pattern. Variations in ultraviolet B (UVB) light during seasons affects cutaneous synthesis of vitamin D 3 . Serum vitamin D concentration influences the expression of airway surface liquid (ASL) antimicrobial peptides such as LL-37.
OBJECTIVE


We sought to determine the effect of seasons on serum vitamin D levels and ASL antimicrobial activity.
METHODS


Forty participants, 18-60 years old, were randomized 1:1 to receive 90 days of 1000 IU vitamin D 3  or placebo. We collected ASL via bronchoscopy and measured serum 25(OH) vitamin D from participants before and after intervention across seasons. We measured ASL antimicrobial activity by challenging samples with bioluminescent  Staphylococcus aureus  and measured relative light units (RLUs) after four minutes. We also investigated the role of LL-37 using a monoclonal neutralizing antibody.
RESULTS


We found that participants, prior to any intervention, during summer-fall ( n  = 20) compared to winter-spring ( n  = 20) had (1) decreased live bacteria after challenge (5542 ± 175.2 vs. 6585 ± 279 RLU,  p  = 0.003) and (2) higher serum vitamin D (88.25 ± 24.25 vs. 67.5 ± 45.25 nmol/L,  p  = 0.026). Supplementation with vitamin D 3  increased vitamin D levels and restored ASL antimicrobial activity only during the winter-spring. The increased ASL antimicrobial activity seen during the summer-fall was abrogated by adding the LL-37 neutralizing antibody.
CONCLUSION


ASL kills bacteria more effectively during the summer-fall compared to the winter-spring. Supplementation of vitamin D during winter-spring restores ASL antimicrobial activity by increasing the expression of antimicrobial peptides including LL-37.",2020,Supplementation of vitamin D during winter-spring restores ASL antimicrobial activity by increasing the expression of antimicrobial peptides including LL-37.,"['Forty participants, 18-60 years old']","['vitamin D 3  or placebo', 'LL-37', 'Placebo', 'vitamin D']","['Seasonal Antimicrobial Activity', 'ASL antimicrobial activity', 'serum 25(OH', 'live bacteria', 'vitamin D levels', 'serum vitamin D']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0042950', 'cui_str': 'Volition'}]","[{'cui': 'C0439601', 'cui_str': 'Seasonal course'}, {'cui': 'C1271650', 'cui_str': 'Antimicrobial activity'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0428586', 'cui_str': 'Serum vitamin D measurement'}]",40.0,0.191566,Supplementation of vitamin D during winter-spring restores ASL antimicrobial activity by increasing the expression of antimicrobial peptides including LL-37.,"[{'ForeName': 'Luis G', 'Initials': 'LG', 'LastName': 'Vargas Buonfiglio', 'Affiliation': 'Department of Internal Medicine, Carver College of Medicine Iowa City, University of Iowa, Iowa City, IA 52242, USA.'}, {'ForeName': 'Oriana G', 'Initials': 'OG', 'LastName': 'Vanegas Calderon', 'Affiliation': 'Department of Pediatrics, Carver College of Medicine Iowa City, University of Iowa, Iowa City, IA 52242, USA.'}, {'ForeName': 'Marlene', 'Initials': 'M', 'LastName': 'Cano', 'Affiliation': 'Department of Internal Medicine, Carver College of Medicine Iowa City, University of Iowa, Iowa City, IA 52242, USA.'}, {'ForeName': 'Jacob E', 'Initials': 'JE', 'LastName': 'Simmering', 'Affiliation': 'Department of Internal Medicine, Carver College of Medicine Iowa City, University of Iowa, Iowa City, IA 52242, USA.'}, {'ForeName': 'Philip M', 'Initials': 'PM', 'LastName': 'Polgreen', 'Affiliation': 'Department of Internal Medicine, Carver College of Medicine Iowa City, University of Iowa, Iowa City, IA 52242, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Zabner', 'Affiliation': 'Department of Internal Medicine, Carver College of Medicine Iowa City, University of Iowa, Iowa City, IA 52242, USA.'}, {'ForeName': 'Alicia K', 'Initials': 'AK', 'LastName': 'Gerke', 'Affiliation': 'Department of Internal Medicine, Carver College of Medicine Iowa City, University of Iowa, Iowa City, IA 52242, USA.'}, {'ForeName': 'Alejandro P', 'Initials': 'AP', 'LastName': 'Comellas', 'Affiliation': 'Department of Internal Medicine, Carver College of Medicine Iowa City, University of Iowa, Iowa City, IA 52242, USA.'}]",Nutrients,['10.3390/nu12092602']
2564,32867083,"Effect of White Potatoes on Subjective Appetite, Food Intake, and Glycemic Response in Healthy Older Adults.","The objective of this study was to determine the effect of white potato cooking methods on subjective appetite, short-term food intake (FI), and glycemic response in healthy older adults. Using a within-subject, repeated-measures design, 20 participants (age: 70.4 ± 0.6 y) completed, in random order, five treatment conditions: three potato treatments (baked potatoes, mashed potatoes, and French fries), an isocaloric control treatment (white bread), or a fasting condition (meal skipping). Subjective appetite and glycemic response were measured for 120 min using visual analogue scales and capillary blood samples, respectively. Lunch FI was measured with an ad libitum pizza meal at 120 min. Change from baseline subjective appetite ( p  < 0.001) and lunch FI ( p  < 0.001) were lower after all test treatments compared with meal skipping ( p  < 0.001), but did not differ among test treatments. Cumulative FI (test treatment + lunch FI) did not differ among treatment conditions. Blood glucose concentrations were higher after all test treatments compared with meal skipping ( p  < 0.001), but were not different from each other. In healthy older adults, white potatoes suppressed subjective appetite and lunch FI compared with meal skipping, suggesting white potatoes do not bypass regulatory control mechanisms of FI.",2020,"Blood glucose concentrations were higher after all test treatments compared with meal skipping ( p  < 0.001), but were not different from each other.","['Healthy Older Adults', '20 participants (age: 70.4 ± 0.6 y) completed, in random order, five treatment conditions: three', 'healthy older adults']","['white potato cooking methods', 'potato treatments (baked potatoes, mashed potatoes, and French fries), an isocaloric control treatment (white bread), or a fasting condition (meal skipping', 'Lunch FI was measured with an ad libitum pizza meal', 'White Potatoes']","['lunch FI', 'Blood glucose concentrations', 'subjective appetite, short-term food intake (FI), and glycemic response', 'baseline subjective appetite', 'Cumulative FI', 'Subjective Appetite, Food Intake, and Glycemic Response', 'Subjective appetite and glycemic response']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4068883', 'cui_str': '0.6'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0032846', 'cui_str': 'Potato'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1510451', 'cui_str': 'French fries'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0452550', 'cui_str': 'White bread'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0560435', 'cui_str': 'Does skip'}, {'cui': 'C2697949', 'cui_str': 'Lunch'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0453577', 'cui_str': 'Pizza'}]","[{'cui': 'C2697949', 'cui_str': 'Lunch'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C2585282', 'cui_str': 'Blood glucose concentration'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",20.0,0.0325709,"Blood glucose concentrations were higher after all test treatments compared with meal skipping ( p  < 0.001), but were not different from each other.","[{'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Bellissimo', 'Affiliation': 'School of Nutrition, Faculty of Community Services, Ryerson University, 350 Victoria Street, Toronto, ON M5B 2K3, Canada.'}, {'ForeName': 'Robena', 'Initials': 'R', 'LastName': 'Amalraj', 'Affiliation': 'School of Nutrition, Faculty of Community Services, Ryerson University, 350 Victoria Street, Toronto, ON M5B 2K3, Canada.'}, {'ForeName': 'Jennifer J', 'Initials': 'JJ', 'LastName': 'Lee', 'Affiliation': 'School of Nutrition, Faculty of Community Services, Ryerson University, 350 Victoria Street, Toronto, ON M5B 2K3, Canada.'}, {'ForeName': 'Neil R', 'Initials': 'NR', 'LastName': 'Brett', 'Affiliation': 'School of Nutrition, Faculty of Community Services, Ryerson University, 350 Victoria Street, Toronto, ON M5B 2K3, Canada.'}, {'ForeName': 'Julia O', 'Initials': 'JO', 'LastName': 'Totosy de Zepetnek', 'Affiliation': 'Faculty of Kinesiology and Health Studies, University of Regina, 3737 Wascana Parkway, Regina, SK S4S 0A2, Canada.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Proteau', 'Affiliation': 'School of Nutrition, Faculty of Community Services, Ryerson University, 350 Victoria Street, Toronto, ON M5B 2K3, Canada.'}, {'ForeName': 'Dérick', 'Initials': 'D', 'LastName': 'Rousseau', 'Affiliation': 'Department of Chemistry and Biology, Faculty of Science, Ryerson University, 350 Victoria Street, Toronto, ON M5B 2K3, Canada.'}]",Nutrients,['10.3390/nu12092606']
2565,32869246,[The Influence of a Statement of Truth on the Authenticity of Complaints].,"BACKGROUND


Implicit motives have a moderating effect on dishonest answering behaviour during the testing of applicants for disability pensions. Persons would rather act dishonest if they do not have do keep up their positive self-image therefore.
OBJECTIVE


Does a statement of truth at the beginning of a functional capacity evaluation lead to lower dishonest answering behaviour?
METHODS


248 applicants for a disability pension were randomly allocated to giving such a statement either before or after symptom validity tests (SIMS, BEVA).
RESULTS


The statement of truth affected the SIMS but not the BEVA. The effect depended on the education level.
CONCLUSION


Moral and social motives have to be taken into account when assessing malingering during a functional capacity evaluation. Higher educated persons refer to other moral standards or take a more individual and case-by-case approach to morally challenging situations.",2020,"BACKGROUND


Implicit motives have a moderating effect on dishonest answering behaviour during the testing of applicants for disability pensions.",['248 applicants for a disability pension'],[],[],"[{'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0030854', 'cui_str': 'Retirement Benefits'}]",[],[],248.0,0.0275614,"BACKGROUND


Implicit motives have a moderating effect on dishonest answering behaviour during the testing of applicants for disability pensions.","[{'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Kobelt-Pönicke', 'Affiliation': 'Deutsche Rentenversicherung Braunschweig-Hannover, Laatzen.'}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Walter', 'Affiliation': 'Zentrum für Klinische Psychologie und Rehabilitation, Universität Bremen, Bremen.'}, {'ForeName': 'Naina', 'Initials': 'N', 'LastName': 'Lid', 'Affiliation': 'Zentrum für Klinische Psychologie und Rehabilitation, Universität Bremen, Bremen.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Ramien', 'Affiliation': 'Zentrum für Klinische Psychologie und Rehabilitation, Universität Bremen, Bremen.'}]",Die Rehabilitation,['10.1055/a-1195-7986']
2566,32869247,[Stay at Work - Feasibility and Acceptance of a Part-Time Medical Rehabilitation].,"PURPOSE


Back pain is associated with significant impairments of participation, which should be prevented by medical rehabilitation programs. The existing evidence shows that the German rehabilitation model is not effective for all target groups. In addition to intensified measures for patients with a high risk of failed return to work, a less intense rehabilitation form could be useful for patients with moderate disabilities. Therefore, in this study the feasibility of a part-time medical rehabilitation (German abbreviation: BbR) was examined. The BbR was designed as a closed group program with a therapy duration of 48 hours (2 appointments per week over 12 weeks). Furthermore, different access paths to BbR as well as the effects were focused.
METHODS


Twelve groups with 6 to 12 participants each were planned in 3 outpatient rehabilitation centers. In addition to the regular application process, insured persons were recruited via the network of rehabilitation centers as well as the company service of the German Pension Insurance. The BbR focused on employed patients who were not on sick-leave and had the need for rehabilitation due to back pain. The evaluation was multi-perspective and multi-methodical. All participants completed questionnaires at admission, while and at discharge of the BbR. In addition, discussions in groups were conducted with representatives of the rehabilitation centers, the pension insurance and employers.
RESULTS


In total, 7 groups with 56 participants could be realized in 2 rehabilitation centers. The typical BbR-participant was female, married, without children, 48 years old and working full for medium-sizes enterprise without shift work. The majority had no or minor no time of sick-leave in the year prior to rehabilitation. 59% of them were recruited by the rehabilitation centers; only few persons were assigned by the pension insurance. Two thirds would not have applied for a medical rehabilitation without the offer of BbR. Overall, the participants were very satisfied with the BbR. However, the compatibility of the BbR with the job and everyday life was perceived as a challenge. A pre-post comparison showed moderate to strong differences in self-rated health, pain, functional status and work ability.
CONCLUSION


The BbR seems to be a useful additional concept in the German rehabilitation system for patients with moderate disabilities. Before dissemination, the identified challenges should be solved. This applies in particular to the recruitment and compatibility of rehabilitation with work and everyday life.",2020,"A pre-post comparison showed moderate to strong differences in self-rated health, pain, functional status and work ability.
","['typical BbR-participant was female, married, without children, 48 years old and working full for medium-sizes enterprise without shift work', 'patients with moderate disabilities', 'Twelve groups with 6 to 12 participants each were planned in 3 outpatient rehabilitation centers', 'In total, 7 groups with 56 participants could be realized in 2 rehabilitation centers', 'insured persons were recruited via the network of rehabilitation centers as well as the company service of the German Pension Insurance']",[],"['Stay at Work - Feasibility and Acceptance', 'time of sick-leave', 'self-rated health, pain, functional status and work ability']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0024841', 'cui_str': 'Marriage'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0425104', 'cui_str': 'Shift worker'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0034993', 'cui_str': 'Centers, Rehabilitation'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0030854', 'cui_str': 'Retirement Benefits'}, {'cui': 'C0021672', 'cui_str': 'Insurance'}]",[],"[{'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0242807', 'cui_str': 'Sick Leave'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",,0.0229851,"A pre-post comparison showed moderate to strong differences in self-rated health, pain, functional status and work ability.
","[{'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Kohl', 'Affiliation': 'Hochschule der Bundesagentur für Arbeit, Schwerin (bis 10/2019 Forschungsinstitut Betriebliche Bildung (f-bb), Nürnberg).'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Kulisch', 'Affiliation': 'Deutsche Rentenversicherung Bund, Berlin.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Lorenz', 'Affiliation': 'Forschungsinstitut Betriebliche Bildung (f-bb), Nürnberg.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Streibelt', 'Affiliation': 'Deutsche Rentenversicherung Bund, Berlin.'}]",Die Rehabilitation,['10.1055/a-1151-7345']
2567,32872123,A Nursery-Based Cooking Skills Programme with Parents and Children Reduced Food Fussiness and Increased Willingness to Try Vegetables: A Quasi-Experimental Study.,"Children's fussy eating is associated with a reduced vegetable intake. This quasi-experimental study evaluated ""Big Chef Little Chef"" (BCLC), a nursery-based cooking skills programme aimed at reducing food fussiness and increasing willingness to try green vegetables by incorporating repeated exposure and sensory learning. Parent and child (3-5 years) dyads attended BCLC for four/1.5 h weekly sessions. A comparison group was recruited after BCLC completion and attended a single education session at week 1. A questionnaire measured food fussiness at week 1 and week 4. At week 4, all children were offered six green vegetables (raw and cooked) and an average score (1 = did not try; 2 = tried it/ate some; 3 = ate it all) was calculated for willingness to try vegetables. In total, 121 dyads (intervention:  n  = 64; comparison:  n  = 57) participated. The food fussiness score (1 min-5 max) in the intervention group decreased significantly from 3.0 to 2.6 ( p  < 0.01) between time points, while there was no change in the comparison group (3.1 (week 1) and 3.0 (week 4)). The intervention group was more willing to try green vegetables with significantly higher ( p  < 0.001) median scores for raw and cooked vegetables (2.5 for both) compared with the comparison group (2.0 and 1.7, respectively). The BCLC reduced food fussiness and increased willingness to try green vegetables.",2020,"The intervention group was more willing to try green vegetables with significantly higher ( p  < 0.001) median scores for raw and cooked vegetables (2.5 for both) compared with the comparison group (2.0 and 1.7, respectively).","[""Children's fussy eating"", 'In total, 121 dyads (intervention:  n  = 64; comparison:  n  = 57) participated']","['Big Chef Little Chef"" (BCLC']","['Food Fussiness and Increased Willingness to Try Vegetables', 'median scores for raw and cooked vegetables', 'food fussiness score']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0554202', 'cui_str': 'Chef'}, {'cui': 'C0023882', 'cui_str': 'Spastic diplegia'}]","[{'cui': 'C5197784', 'cui_str': 'Picky Eating'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0001884', 'cui_str': 'Airway Resistance'}, {'cui': 'C3853209', 'cui_str': 'Cooked vegetable'}]",121.0,0.0204112,"The intervention group was more willing to try green vegetables with significantly higher ( p  < 0.001) median scores for raw and cooked vegetables (2.5 for both) compared with the comparison group (2.0 and 1.7, respectively).","[{'ForeName': 'Ada L', 'Initials': 'AL', 'LastName': 'Garcia', 'Affiliation': 'Human Nutrition, School of Medicine, Dentistry and Nursing, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow G31 2ER, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Brown', 'Affiliation': 'Human Nutrition, School of Medicine, Dentistry and Nursing, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow G31 2ER, UK.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Goodale', 'Affiliation': 'Academic Achievement Team, Library Services, Liverpool John Moores University, Liverpool L3 5UX, UK.'}, {'ForeName': 'Mairi', 'Initials': 'M', 'LastName': 'McLachlan', 'Affiliation': 'Lanarkshire Community Food and Health Partnership, Bargeddie G69 7TU, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Parrett', 'Affiliation': 'Human Nutrition, School of Medicine, Dentistry and Nursing, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow G31 2ER, UK.'}]",Nutrients,['10.3390/nu12092623']
2568,32873953,The effect of body acid-base state and manipulations on body glucose regulation in human.,"Long-term exposure to high dietary acid load has been associated with insulin resistance and type 2 diabetes in epidemiological studies. However, it remains unclear whether the acid load of the diet translates to mild metabolic acidosis and whether it is responsible for the impairment in glucose regulation in humans. Previously, in a cross-sectional study we have reported that dietary acid load was not different between healthy individuals with normal weight and those with overweight/obesity, irrespective of insulin sensitivity. However, 4-week high acid load diet increased plasma lactate (a small component of the anion gap) and increased insulin resistance in healthy participants. The change in plasma lactate correlated significantly with the change in insulin resistance. Because cause-and-effect could not be evaluated in these settings, we sought to directly test the effect of an alkalizing treatment preload on postprandial glucose regulation. In a randomized placebo-controlled study with a crossover design, we administered sodium bicarbonate (NaHCO 3 , 1.68 g) prior to high acid load meal to healthy individuals. We found that while the bicarbonate preload attenuated the post meal decrease in pH observed with placebo, no effect on postprandial glucose regulation (glucose, insulin, and C-peptide) was observed. Following 3-month treatment of nondiabetic individuals with bicarbonate, others have reported no change in insulin resistance markers, consistent with our findings. Together, studies in human suggest that insulin resistance associated with longstanding obesogenic diet may be mediated by mild metabolic acidosis. However, buffering the Western diet with bicarbonate and increasing body pH does not change glucose homeostasis in nondiabetic individuals. Further studies are required to shed light on the role of body acid-base balance and glucose homeostasis in health and disease.",2020,The change in plasma lactate correlated significantly with the change in insulin resistance.,"['human', 'nondiabetic individuals', 'healthy individuals with normal weight and those with overweight/obesity, irrespective of insulin sensitivity', 'to healthy individuals', 'healthy participants', 'nondiabetic individuals with']","['placebo', 'sodium bicarbonate (NaHCO 3 , 1.68\u2009g) prior to high acid load meal', 'body acid-base state and manipulations', 'bicarbonate']","['body glucose regulation', 'postprandial glucose regulation (glucose, insulin, and C-peptide', 'insulin resistance', 'plasma lactate', 'insulin resistance markers']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C2712185', 'cui_str': 'Normal weight'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0074722', 'cui_str': 'Sodium Bicarbonate'}, {'cui': 'C5191337', 'cui_str': '1.68'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}, {'cui': 'C0005367', 'cui_str': 'Bicarbonate'}]","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0006558', 'cui_str': 'C-peptide'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",,0.0620342,The change in plasma lactate correlated significantly with the change in insulin resistance.,"[{'ForeName': 'Eliza', 'Initials': 'E', 'LastName': 'Chalmers', 'Affiliation': 'Diabetes & Metabolism Division, Garvan Institute of Medical Research, Sydney, NSW, Australia.'}, {'ForeName': 'Dorit', 'Initials': 'D', 'LastName': 'Samocha-Bonet', 'Affiliation': 'Diabetes & Metabolism Division, Garvan Institute of Medical Research, Sydney, NSW, Australia. d.samochabonet@garvan.org.au.'}]",European journal of clinical nutrition,['10.1038/s41430-020-0692-6']
2569,32855160,Glucose as the Fifth Vital Sign: A Randomized Controlled Trial of Continuous Glucose Monitoring in a Non-ICU Hospital Setting.,"OBJECTIVE


The current standard for hospital glucose management is point-of-care (POC) testing. We conducted a randomized controlled trial of real-time continuous glucose monitoring (RT-CGM) compared with POC in a non-intensive care unit (ICU) hospital setting.
RESEARCH DESIGN AND METHODS


A total of 110 adults with type 2 diabetes on a non-ICU floor received RT-CGM with Dexcom G6 versus usual care (UC). RT-CGM data were wirelessly transmitted from the bedside. Hospital telemetry monitored RT-CGM data and notified bedside nursing of glucose alerts and trends. Standardized protocols were used for interventions.
RESULTS


The RT-CGM group demonstrated significantly lower mean glucose (M∆ = -18.5 mg/dL) and percentage of time in hyperglycemia >250 mg/dL (-11.41%) and higher time in range 70-250 mg/dL (+11.26%) compared with UC ( P  values <0.05). Percentage of time in hypoglycemia was very low.
CONCLUSIONS


RT-CGM can be used successfully in community-based hospital non-ICU settings to improve glucose management. Continuously streaming glucose readings may truly be the fifth vital sign.",2020,The RT-CGM group demonstrated significantly lower mean glucose,"['110 adults with type 2 diabetes (T2D) on a non-ICU floor received', 'in a Non-ICU Hospital Setting']","['RT-CGM', 'RT-CGM with Dexcom G6 versus usual care (UC', 'real-time CGM (RT-CGM', 'Continuous Glucose Monitoring']","['Percentage of time in hypoglycemia', 'percentage of time in hyperglycemia', 'higher median time', 'mean glucose']","[{'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0016249', 'cui_str': 'Walking surface of room'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}]",110.0,0.0208514,The RT-CGM group demonstrated significantly lower mean glucose,"[{'ForeName': 'Addie L', 'Initials': 'AL', 'LastName': 'Fortmann', 'Affiliation': 'Scripps Whittier Diabetes Institute, San Diego, CA.'}, {'ForeName': 'Samantha R', 'Initials': 'SR', 'LastName': 'Spierling Bagsic', 'Affiliation': 'Scripps Whittier Diabetes Institute, San Diego, CA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Talavera', 'Affiliation': 'Scripps Whittier Diabetes Institute, San Diego, CA.'}, {'ForeName': 'Isabel Maria', 'Initials': 'IM', 'LastName': 'Garcia', 'Affiliation': 'Scripps Whittier Diabetes Institute, San Diego, CA.'}, {'ForeName': 'Haley', 'Initials': 'H', 'LastName': 'Sandoval', 'Affiliation': 'Scripps Whittier Diabetes Institute, San Diego, CA.'}, {'ForeName': 'Amiry', 'Initials': 'A', 'LastName': 'Hottinger', 'Affiliation': 'Scripps Whittier Diabetes Institute, San Diego, CA.'}, {'ForeName': 'Athena', 'Initials': 'A', 'LastName': 'Philis-Tsimikas', 'Affiliation': 'Scripps Whittier Diabetes Institute, San Diego, CA tsimikas.athena@scrippshealth.org.'}]",Diabetes care,['10.2337/dc20-1016']
2570,32858229,A multi-modal virtual reality treadmill intervention for enhancing mobility and cognitive function in people with multiple sclerosis: Protocol for a randomized controlled trial.,"BACKGROUND


Gait and cognitive impairments are common in individuals with Multiple Sclerosis (MS) and can interfere with everyday function. Those with MS have difficulties executing cognitive tasks and walking simultaneously, a reflection of dual-task interference. Therefore, dual-task training may improve functional ambulation. Additionally, using technology such as virtual reality can provide personalized rehabilitation while mimicking real-world environments. The purpose of this randomized controlled trial is to establish the benefits of a combined cognitive-motor virtual reality training on MS symptoms compared to conventional treadmill training.
METHODS


This study will be a single-blinded, two arm RCT with a six-week intervention period. 144 people with MS will be randomized into a treadmill training alone group or treadmill training with virtual reality group. Both groups will receive 18 sessions of training while walking on a treadmill, with the virtual reality group receiving feedback from the virtual system. Primary outcome measures include dual-task gait speed and information processing speed, which will be measured prior to training, one-week post-training, and three months following training.
DISCUSSION


This study will provide insight into the ability of a multi-modal cognitive-motor intervention to reduce dual-task cost and to enhance information processing speed in those with MS. This is one of the first studies that is powered to understand whether targeted dual-task training can improve MS symptoms and increase functional ambulation. We anticipate that those in the virtual reality group will have a significantly greater increase in dual-task gait speed and information processing speed than those achieved via treadmill training alone.",2020,We anticipate that those in the virtual reality group will have a significantly greater increase in dual-task gait speed and information processing speed than those achieved via treadmill training alone.,"['people with multiple sclerosis', '144 people with MS', 'individuals with Multiple Sclerosis (MS']","['conventional treadmill training', 'combined cognitive-motor virtual reality training', 'modal virtual reality treadmill intervention', 'treadmill training alone group or treadmill training with virtual reality group', 'dual-task training', 'training while walking on a treadmill, with the virtual reality group receiving feedback from the virtual system']","['dual-task gait speed and information processing speed, which will be measured prior to training, one-week post-training, and three months following training', 'mobility and cognitive function', 'functional ambulation', 'dual-task gait speed and information processing speed', 'MS symptoms and increase functional ambulation', 'MS symptoms']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C4760627', 'cui_str': '144'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0376392', 'cui_str': 'Virtual Systems'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0021420', 'cui_str': 'Information Processing'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C4082119', 'cui_str': 'Three months'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",144.0,0.0521126,We anticipate that those in the virtual reality group will have a significantly greater increase in dual-task gait speed and information processing speed than those achieved via treadmill training alone.,"[{'ForeName': 'K L', 'Initials': 'KL', 'LastName': 'Hsieh', 'Affiliation': 'Department of Kinesiology and Community Health, University of Illinois at Urbana-Champaign, Urbana, IL, USA; Illinois Multiple Sclerosis Research Collaborative, Interdisciplinary Health Science Institute, University of Illinois at Urbana-Champaign, Urbana, IL, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Mirelman', 'Affiliation': 'Center for the Study of Movement, Cognition and Mobility, Neurological Institute, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel; Sagol School of Neuroscience, Tel Aviv University, Tel Aviv, Israel; Department of Neurology, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Shema-Shiratzky', 'Affiliation': 'Center for the Study of Movement, Cognition and Mobility, Neurological Institute, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Galperin', 'Affiliation': 'Center for the Study of Movement, Cognition and Mobility, Neurological Institute, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Regev', 'Affiliation': 'Neuroimmunology and Multiple Sclerosis Unit of the Neurology Division, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Shen', 'Affiliation': 'Department of Kinesiology and Community Health, University of Illinois at Urbana-Champaign, Urbana, IL, USA.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Schmitz-Hübsch', 'Affiliation': 'NeuroCure, Charité - Universitaetsmedizin Berlin, Berlin, Germany; Experimental and Clinical Research Center, Max Delbrueck Center for Molecular Medicine and Charité - Universitaetsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Karni', 'Affiliation': 'Sagol School of Neuroscience, Tel Aviv University, Tel Aviv, Israel; Department of Neurology, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel; Neuroimmunology and Multiple Sclerosis Unit of the Neurology Division, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Paul', 'Affiliation': 'NeuroCure, Charité - Universitaetsmedizin Berlin, Berlin, Germany; Experimental and Clinical Research Center, Max Delbrueck Center for Molecular Medicine and Charité - Universitaetsmedizin Berlin, Berlin, Germany; Department of Neurology, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Devos', 'Affiliation': 'Laboratory for Advanced Rehabilitation Research in Simulation, Department of Physical Therapy and Rehabilitation Science, School of Health Professions, University of Kansas Medical Center, Kansas City, KS, United States of America.'}, {'ForeName': 'J J', 'Initials': 'JJ', 'LastName': 'Sosnoff', 'Affiliation': 'Department of Kinesiology and Community Health, University of Illinois at Urbana-Champaign, Urbana, IL, USA; Illinois Multiple Sclerosis Research Collaborative, Interdisciplinary Health Science Institute, University of Illinois at Urbana-Champaign, Urbana, IL, USA.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Hausdorff', 'Affiliation': ""Center for the Study of Movement, Cognition and Mobility, Neurological Institute, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel; Sagol School of Neuroscience, Tel Aviv University, Tel Aviv, Israel; Department of Physical Therapy, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel; Rush Alzheimer's Disease Center and Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, IL, USA. Electronic address: jhausdor@tlvmc.gov.il.""}]",Contemporary clinical trials,['10.1016/j.cct.2020.106122']
2571,32860406,The effect of intracoronary infusion of bone marrow-derived mononuclear cells on all-cause mortality in acute myocardial infarction: the BAMI trial.,"AIMS 


Bone marrow-derived mononuclear cell (BM-MNC) therapy may improve myocardial recovery in patients following acute myocardial infarction (AMI), though existing trial results are inconsistent.
METHODS AND RESULTS 


Originally an open-label, multicentre Phase III trial, BAMI was designed to demonstrate the safety and efficacy of intracoronary infusion of BM-MNCs in reducing the time to all-cause mortality in patients with reduced left ventricular ejection fraction (LVEF, ≤45%) after primary angioplasty (PPCI) for ST-elevation AMI. Unexpectedly low recruitment means the trial no longer qualifies as a hypothesis-testing trial, but is instead an observational study with no definitive conclusions possible from statistical analysis. In total, 375 patients were recruited: 185 patients were randomized to the treatment arm (intracoronary infusion of BM-MNCs 2-8 days after PPCI) and 190 patients to the control arm (optimal medical therapy). All-cause mortality at 2 years was 3.26% [6 deaths; 95% confidence interval (CI): 1.48-7.12%] in the BM-MNC group and 3.82% (7 deaths; 95% CI: 1.84-7.84%) in the control group. Five patients (2.7%, 95% CI: 1.0-5.9%) in the BM-MNC group and 15 patients (8.1%, CI : 4.7-12.5%) in the control group were hospitalized for heart failure during 2 years of follow-up. Neither adverse events nor serious adverse events differed between the two groups. There were no patients hospitalized for stroke in the control group and 4 (2.2%) patients hospitalized for stroke in the BM-MNC group.
CONCLUSIONS 


Although BAMI is the largest trial of autologous cell-based therapy in the treatment of AMI, unexpectedly low recruitment and event rates preclude any meaningful group comparisons and interpretation of the observed results.",2020,All-cause mortality at 2 years was 3.26% [6 deaths; 95% confidence interval (CI): 1.48-7.12%] in the BM-MNC group and 3.82% (7 deaths; 95% CI: 1.84-7.84%) in the control group.,"['acute myocardial infarction', 'patients following acute myocardial infarction (AMI', '375 patients were recruited: 185 patients', 'patients with reduced left ventricular ejection fraction (LVEF, ≤45%) after primary angioplasty (PPCI) for ST-elevation AMI']","['Bone marrow-derived mononuclear cell', 'treatment arm (intracoronary infusion of BM-MNCs 2-8\u2009days after PPCI', 'intracoronary infusion of bone marrow-derived mononuclear cells', 'BM-MNC) therapy']","['adverse events nor serious adverse events', 'hospitalized for stroke', 'myocardial recovery', 'heart failure']","[{'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C4517745', 'cui_str': '375'}, {'cui': 'C4517617', 'cui_str': '185'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0162577', 'cui_str': 'Angioplasty of blood vessel'}, {'cui': 'C0520886', 'cui_str': 'ST segment elevation'}]","[{'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C1294062', 'cui_str': 'Mononuclear cell count'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0595454', 'cui_str': 'Intracoronary route'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0574187', 'cui_str': 'Manchu language'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]",375.0,0.0908235,All-cause mortality at 2 years was 3.26% [6 deaths; 95% confidence interval (CI): 1.48-7.12%] in the BM-MNC group and 3.82% (7 deaths; 95% CI: 1.84-7.84%) in the control group.,"[{'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Mathur', 'Affiliation': 'Centre for Cardiovascular Medicine & Devices, Queen Mary University of London, London EC1M 6BQ, UK.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Fernández-Avilés', 'Affiliation': 'Hospital General Universitario Gregorio Marañón, Instituto de Investigación Sanitaria del Hospital Gregorio Marañón, CIBERCV, Madrid, Spain.'}, {'ForeName': 'Jozef', 'Initials': 'J', 'LastName': 'Bartunek', 'Affiliation': 'Cardiovascular Center, OLV Hospital Aalst, Aalst, Belgium.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Belmans', 'Affiliation': 'KU, Leuven, Leuven, Belgium.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Crea', 'Affiliation': 'Catholic University of the Sacred Heart, Rome, Italy.'}, {'ForeName': 'Sheik', 'Initials': 'S', 'LastName': 'Dowlut', 'Affiliation': 'Centre for Cardiovascular Medicine & Devices, Queen Mary University of London, London EC1M 6BQ, UK.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Galiñanes', 'Affiliation': ""Department of Cardiac Surgery, Reparative Therapy of the Heart, Vall d'Hebron Research Institute, University Hospital Vall d'Hebron, Autonomous University of Barcelona, Barcelona, Spain.""}, {'ForeName': 'Marie-Claire', 'Initials': 'MC', 'LastName': 'Good', 'Affiliation': 'Queen Mary University of London, London, UK.'}, {'ForeName': 'Juha', 'Initials': 'J', 'LastName': 'Hartikainen', 'Affiliation': 'Kuopio University Hospital, Kuopio, Finland.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Hauskeller', 'Affiliation': 'University of Exeter, Exeter, UK.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Janssens', 'Affiliation': 'University Hospitals (UZ) Leuven, Belgium.'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Kala', 'Affiliation': 'University Hospital Brno and Medical Faculty of Masaryk University, Brno, Czech Republic.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Kastrup', 'Affiliation': 'Rigshospitalet and University of Copenhagen, Denmark.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Martin', 'Affiliation': 'University College London, London, UK.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Menasché', 'Affiliation': 'Department of Cardiovascular Surgery, Hôpital Européen Georges Pompidou and University of Paris, Paris, France.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Sanz-Ruiz', 'Affiliation': 'Hospital General Universitario Gregorio Marañón, Instituto de Investigación Sanitaria del Hospital Gregorio Marañón, CIBERCV, Madrid, Spain.'}, {'ForeName': 'Seppo', 'Initials': 'S', 'LastName': 'Ylä-Herttuala', 'Affiliation': 'University of Eastern Finland, Finland.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Zeiher', 'Affiliation': 'Department of Medicine III, Goethe University of Frankfurt, Frankfurt, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European heart journal,['10.1093/eurheartj/ehaa651']
2572,32859032,The Low Glutamate Diet Effectively Improves Pain and Other Symptoms of Gulf War Illness.,"Gulf War Illness (GWI) is a multisymptom disorder including widespread chronic pain, fatigue and gastrointestinal problems. The objective of this study was to examine the low glutamate diet as a treatment for GWI. Forty veterans with GWI were recruited from across the US. Outcomes included symptom score, myalgic score, tender point count, dolorimetry and the Chalder Fatigue Scale. Subjects were randomized to the low glutamate diet or a wait-listed control group, with symptom score being compared after one month. Subjects then went onto a double-blind, placebo-controlled crossover challenge with monosodium glutamate (MSG)/placebo to test for return of symptoms. Symptom score was compared between diet intervention and wait-listed controls with an independent t-test and effect size was calculated with Cohen's  d . Change scores were analyzed with Wilcoxon Signed Rank tests. Crossover challenge results were analyzed with General Linear Models and cluster analysis. The diet intervention group reported significantly less symptoms ( p  = 0.0009) than wait-listed controls, with a very large effect size,  d  = 1.16. Significant improvements in average dolorimetry ( p  = 0.0006), symptom score, tender point number, myalgic score and the Chalder Fatigue Scale (all  p  < 0.0001) were observed after the 1-month diet. Challenge with MSG/placebo resulted in significant variability in individual response. These results suggest that the low glutamate diet can effectively reduce overall symptoms, pain and fatigue in GWI, but differential results upon challenge suggest that other aspects of the diet, or underlying differences within the population, may be driving these changes. Future research is needed to identify potential nutrient effects, biomarkers, and underlying metabolic differences between responders and non-responders.",2020,"Significant improvements in average dolorimetry ( p  = 0.0006), symptom score, tender point number, myalgic score and the Chalder Fatigue Scale (all  p  < 0.0001) were observed after the 1-month diet.",['Forty veterans with GWI'],"['low glutamate diet or a wait-listed control', 'placebo', 'MSG/placebo', 'monosodium glutamate (MSG)/placebo']","['individual response', 'overall symptoms, pain and fatigue in GWI', 'symptom score, tender point number, myalgic score and the Chalder Fatigue Scale', 'average dolorimetry', 'symptom score, myalgic score, tender point count, dolorimetry and the Chalder Fatigue Scale', 'symptoms', 'Symptom score']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C1449761', 'cui_str': 'Persian Gulf War, 1991'}, {'cui': 'C0221423', 'cui_str': 'Illness'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0017789', 'cui_str': 'Glutamates'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0037511', 'cui_str': 'Monosodium glutamate'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C1449761', 'cui_str': 'Persian Gulf War, 1991'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1562820', 'cui_str': 'Tender point'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439157', 'cui_str': 'counts'}]",40.0,0.0335282,"Significant improvements in average dolorimetry ( p  = 0.0006), symptom score, tender point number, myalgic score and the Chalder Fatigue Scale (all  p  < 0.0001) were observed after the 1-month diet.","[{'ForeName': 'Kathleen F', 'Initials': 'KF', 'LastName': 'Holton', 'Affiliation': 'Department of Health Studies, American University, Washington, DC 20016, USA.'}, {'ForeName': 'Anna E', 'Initials': 'AE', 'LastName': 'Kirkland', 'Affiliation': 'Program in Behavior, Cognition and Neuroscience, American University, Washington, DC 20016, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Baron', 'Affiliation': 'Department of Mathematics & Statistics, American University, Washington, DC 20016, USA.'}, {'ForeName': 'Shalini S', 'Initials': 'SS', 'LastName': 'Ramachandra', 'Affiliation': 'Department of Health Studies, American University, Washington, DC 20016, USA.'}, {'ForeName': 'Mackenzie T', 'Initials': 'MT', 'LastName': 'Langan', 'Affiliation': 'Neuroscience Program, Department of Biology, American University, Washington, DC 20016, USA.'}, {'ForeName': 'Elizabeth T', 'Initials': 'ET', 'LastName': 'Brandley', 'Affiliation': 'Department of Health Studies, American University, Washington, DC 20016, USA.'}, {'ForeName': 'James N', 'Initials': 'JN', 'LastName': 'Baraniuk', 'Affiliation': 'Department of Medicine, Georgetown University, Washington, DC 20057, USA.'}]",Nutrients,['10.3390/nu12092593']
2573,32859607,Real-time CGM Is Superior to Flash Glucose Monitoring for Glucose Control in Type 1 Diabetes: The CORRIDA Randomized Controlled Trial.,"OBJECTIVE


The aim of this trial was to compare the efficacy of real-time and intermittently scanned continuous glucose monitoring (rtCGM and isCGM, respectively) in maintaining optimal glycemic control.
RESEARCH DESIGN AND METHODS


In this randomized study, adults with type 1 diabetes (T1D) and normal hypoglycemia awareness (Gold score <4) used rtCGM (Guardian Connect Mobile) or isCGM (FreeStyle Libre) during 4 days of physical activity (exercise phase) and in the subsequent 4 weeks at home (home phase). Primary end points were time in hypoglycemia (<3.9 mmol/L [<70 mg/dL]) and time in range (3.9-10.0 mmol/L [70-180 mg/dL]). The isCGM group wore an additional masked Enlite sensor (iPro2) for 6 days to check for bias between the different sensors used by the rtCGM and isCGM systems.
RESULTS


Sixty adults with T1D (mean age 38 ± 13 years; A1C 62 ± 12 mmol/mol [7.8 ± 1.1%]) were randomized to rtCGM ( n  = 30) or isCGM ( n  = 30). All participants completed the study. Percentage of time in hypoglycemia (<3.9 mmol/L [<70 mg/dL]) was lower among rtCGM versus isCGM participants in the exercise phase (6.8 ± 5.5% vs. 11.4 ± 8.6%, respectively;  P  = 0.018) and during the home phase (5.3 ± 2.5% vs. 7.3 ± 4.4%, respectively;  P  = 0.035). Hypoglycemia differences were significant and most notable during the night. rtCGM participants spent more time in range (3.9-10 mmol/L [70-180 mg/dL]) than isCGM participants throughout both the exercise (78.5 ± 10.2% vs. 69.7 ± 16%, respectively;  P  = 0.0149) and home (75.6 ± 9.7% vs. 67.4 ± 17.8%, respectively;  P  = 0.0339) phases. The results were robust to the insignificant bias between rtCGM and isCGM sensors that masked CGM found in the isCGM arm.
CONCLUSIONS


rtCGM was superior to isCGM in reducing hypoglycemia and improving time in range in adults with T1D with normal hypoglycemia awareness, demonstrating the value of rtCGM alarms during exercise and in daily diabetes self-management.",2020,"CONCLUSIONS


rtCGM was superior to isCGM in reducing hypoglycemia and improving time in range in adults with T1D with normal hypoglycemia awareness, demonstrating the value of rtCGM alarms during exercise and in daily diabetes self-management.","['adults with T1D with normal hypoglycemia awareness', 'adults with type 1 diabetes (T1D) and normal hypoglycemia awareness (Gold score <4) used rtCGM (Guardian Connect Mobile) or isCGM (FreeStyle Libre) during 4 days of physical activity (exercise phase) and in the subsequent 4 weeks at home (home phase', 'Sixty adults with T1D (mean age 38 ± 13 years; A1C 62 ± 12 mmol/mol [7.8 ± 1.1', 'Type 1 Diabetes']","['isCGM', 'rtCGM', 'real-time and intermittently scanned continuous glucose monitoring (rtCGM and isCGM', 'isCGM group wore an additional masked Enlite sensor (iPro2', 'Flash Glucose Monitoring']","['Hypoglycemia differences', 'time in hypoglycemia', 'Percentage of time in hypoglycemia', 'hypoglycemia']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011854', 'cui_str': 'Type 1 diabetes mellitus'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0023226', 'cui_str': 'Legal guardian'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}, {'cui': 'C4517491', 'cui_str': '1.1'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}, {'cui': 'C0085635', 'cui_str': 'Photopsia'}]","[{'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439165', 'cui_str': 'Percent'}]",60.0,0.0495856,"CONCLUSIONS


rtCGM was superior to isCGM in reducing hypoglycemia and improving time in range in adults with T1D with normal hypoglycemia awareness, demonstrating the value of rtCGM alarms during exercise and in daily diabetes self-management.","[{'ForeName': 'Aneta', 'Initials': 'A', 'LastName': 'Hásková', 'Affiliation': '3rd Department of Internal Medicine, 1st Faculty of Medicine, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Lucie', 'Initials': 'L', 'LastName': 'Radovnická', 'Affiliation': 'Masaryk Hospital, Ústí nad Labem, Czech Republic.'}, {'ForeName': 'Lenka', 'Initials': 'L', 'LastName': 'Petruželková', 'Affiliation': 'Department of Paediatrics, 2nd Faculty of Medicine, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Christopher G', 'Initials': 'CG', 'LastName': 'Parkin', 'Affiliation': 'CGParkin Communications, Inc., Henderson, NV.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Grunberger', 'Affiliation': 'Grunberger Diabetes Institute, Bloomfield Hills, MI.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Horová', 'Affiliation': '3rd Department of Internal Medicine, 1st Faculty of Medicine, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Vendula', 'Initials': 'V', 'LastName': 'Navrátilová', 'Affiliation': '3rd Department of Internal Medicine, 1st Faculty of Medicine, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Ondřej', 'Initials': 'O', 'LastName': 'Kádě', 'Affiliation': '3rd Department of Internal Medicine, 1st Faculty of Medicine, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Matoulek', 'Affiliation': '3rd Department of Internal Medicine, 1st Faculty of Medicine, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Prázný', 'Affiliation': '3rd Department of Internal Medicine, 1st Faculty of Medicine, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Šoupal', 'Affiliation': '3rd Department of Internal Medicine, 1st Faculty of Medicine, Charles University, Prague, Czech Republic jan.soupal@seznam.cz.'}]",Diabetes care,['10.2337/dc20-0112']
2574,32859608,"Cardiovascular effects of biological versus conventional synthetic disease-modifying antirheumatic drug therapy in treatment-naïve, early rheumatoid arthritis.","OBJECTIVES


To determine whether patients with early rheumatoid arthritis (ERA) have cardiovascular disease (CVD) that is modifiable with disease-modifying antirheumatic drug (DMARD) therapy, comparing first-line etanercept (ETN) + methotrexate (MTX) with MTX strategy.
METHODS


Patients from a phase IV ERA trial randomised to ETN+MTX or MTX strategy±month 6 escalation to ETN+MTX, and with no CVD and maximum one traditional risk factor underwent cardiovascular magnetic resonance (CMR) at baseline, years 1 and 2. Thirty matched controls underwent CMR. Primary outcome measure was aortic distensibility (AD) between controls and ERA, and baseline to year 1 AD change in ERA. Secondary analyses between and within ERA groups performed. Additional outcome measures included left ventricular (LV) mass and myocardial extracellular volume (ECV).
RESULTS


Eighty-one patients recruited. In ERA versus controls, respectively, baseline (geometric mean, 95% CI) AD was significantly lower (3.0×10 -3  mm Hg -1  (2.7-3.3) vs 4.4×10 -3  mm Hg -1  (3.7-5.2), p<0.001); LV mass significantly lower (78.2 g (74.0-82.7), n=81 vs 92.9 g (84.8-101.7), n=30, p<0.01); and ECV increased (27.1% (26.4-27.9), n=78 vs 24.9% (23.8-26.1), n=30, p<0.01). Across all patients, AD improved significantly from baseline to year 1 (3.0×10 -3  mm Hg -1  (2.7-3.4) to 3.6×10 -3  mm Hg -1  (3.1-4.1), respectively, p<0.01), maintained at year 2. The improvement in AD did not differ between the two treatment arms and disease activity state (Disease Activity Score with 28 joint count)-erythrocyte sedimentation rate-defined responders versus non-responders.
CONCLUSION


We report the first evidence of vascular and myocardial abnormalities in an ERA randomised controlled trial cohort and show improvement with DMARD therapy. The type of DMARD (first-line tumour necrosis factor-inhibitors or MTX) and clinical response to therapy did not affect CVD markers.
TRIAL REGISTRATION NUMBER


ISRCTN: ISRCTN89222125; ClinicalTrials.gov: NCT01295151.",2020,"The improvement in AD did not differ between the two treatment arms and disease activity state (Disease Activity Score with 28 joint count)-erythrocyte sedimentation rate-defined responders versus non-responders.
","['Patients from a phase IV ERA trial randomised to', 'patients with early rheumatoid arthritis (ERA', 'Eighty-one patients recruited']","['DMARD therapy', 'CMR', 'etanercept (ETN) + methotrexate (MTX) with MTX strategy', 'biological versus conventional synthetic disease-modifying antirheumatic drug therapy', 'ETN+MTX or MTX strategy±month 6 escalation to ETN+MTX, and with no CVD and maximum one traditional risk factor underwent cardiovascular magnetic resonance (CMR']","['ECV', 'LV mass', 'disease activity state (Disease Activity Score', 'left ventricular (LV) mass and myocardial extracellular volume (ECV', 'aortic distensibility (AD) between controls and ERA, and baseline to year 1 AD change in ERA']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4517884', 'cui_str': '81'}]","[{'cui': 'C0242708', 'cui_str': 'Disease-Modifying Antirheumatic Drugs'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C0717758', 'cui_str': 'Etanercept'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}]","[{'cui': 'C0521119', 'cui_str': 'Extracellular'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0455825', 'cui_str': 'Left ventricular mass'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0003483', 'cui_str': 'Aortic'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",81.0,0.40753,"The improvement in AD did not differ between the two treatment arms and disease activity state (Disease Activity Score with 28 joint count)-erythrocyte sedimentation rate-defined responders versus non-responders.
","[{'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Plein', 'Affiliation': 'Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK.'}, {'ForeName': 'Bara', 'Initials': 'B', 'LastName': 'Erhayiem', 'Affiliation': 'Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Fent', 'Affiliation': 'Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Horton', 'Affiliation': 'Central Lancashire Moving Well Service, Lancashire and South Cumbria NHS Foundation Trust, Lancashire, UK.'}, {'ForeName': 'Raluca Bianca', 'Initials': 'RB', 'LastName': 'Dumitru', 'Affiliation': 'Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Andrews', 'Affiliation': 'Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Greenwood', 'Affiliation': 'Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Emery', 'Affiliation': 'Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.'}, {'ForeName': 'Elizabeth Ma', 'Initials': 'EM', 'LastName': 'Hensor', 'Affiliation': 'Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Baxter', 'Affiliation': 'Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Pavitt', 'Affiliation': 'Dental Translational and Clinical Research Unit, University of Leeds, Leeds, UK.'}, {'ForeName': 'Maya H', 'Initials': 'MH', 'LastName': 'Buch', 'Affiliation': 'Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK maya.buch@manchester.ac.uk.'}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2020-217653']
2575,32859615,Effect of Exercise or Metformin on Biomarkers of Inflammation in Breast and Colorectal Cancer: A Randomized Trial.,"Observational studies report that physical activity and metformin are associated with improved clinical outcome in patients with cancer. Inflammation is one biological mechanism hypothesized to mediate these associations. In this phase II, multicenter, 2 × 2 factorial trial, 139 patients with breast and colorectal cancer who completed standard therapy were randomized to one of four treatment groups for 12 weeks: exercise alone, metformin alone, exercise and metformin, or control. Inflammation outcomes included high-sensitivity C-reactive protein (hs-CRP), soluble tumor necrosis factor alpha receptor two (sTNFαR2), and IL6. The primary modeling strategy evaluated the trial product estimand that was quantified using a generalized linear mixed model. Compared with control, exercise alone reduced hs-CRP [-30.2%; 95% confidence interval (CI), -50.3, -1.0] and IL6 (-30.9%; 95% CI, -47.3, -9.5) but did not change sTNFαR2 (1.0%; 95% CI, -10.4, 13.9). Compared with control, metformin alone did not change hs-CRP (-13.9%; 95% CI, -40.0, 23.4), sTNFαR2 (-10.4%; 95% CI, -21.3, 2.0), or IL6 (-22.9%; 95% CI, -42.3, 2.0). Compared with control, exercise and metformin reduced sTNFαR2 (-13.1%; 95% CI, -22.9, -1.0) and IL6 (-38.7%; 95% CI, -52.3, -18.9) but did not change hs-CRP (-20.5%; 95% CI, -44.0, 12.7). The combination of exercise and metformin was not synergistic for hs-CRP, sTNFαR2, or IL6. In survivors of breast and colorectal cancer with low baseline physical activity and without type 2 diabetes, exercise and metformin reduced measures of inflammation that are associated with cancer recurrence and mortality.",2020,"Compared with control, exercise alone reduced hs-CRP: -30.2% (95% CI: -50.3, -1.0) and IL-6: -30.9% (95% CI: -47.3, -9.5); but did not change sTNF-αR2: 1.0% (95% CI: -10.4, 13.9).","['Breast and Colorectal Cancer', '139 patients with breast and colorectal cancer who completed standard therapy', 'patients with cancer']","['Exercise or Metformin', 'exercise alone, metformin alone, exercise and metformin, or control', 'metformin', 'exercise and metformin']","['high sensitivity C-reactive protein (hs-CRP), soluble tumor necrosis factor alpha receptor two (sTNF-αR2), and interleukin 6 (IL-6', 'change hs-CRP', 'cancer recurrence and mortality', 'sTNF-αR2']","[{'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C1453722', 'cui_str': 'TNFRSF1A protein, human'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",139.0,0.146342,"Compared with control, exercise alone reduced hs-CRP: -30.2% (95% CI: -50.3, -1.0) and IL-6: -30.9% (95% CI: -47.3, -9.5); but did not change sTNF-αR2: 1.0% (95% CI: -10.4, 13.9).","[{'ForeName': 'Justin C', 'Initials': 'JC', 'LastName': 'Brown', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, Louisiana. justin.brown@pbrc.edu.'}, {'ForeName': 'Sui', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Ligibel', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Melinda L', 'Initials': 'ML', 'LastName': 'Irwin', 'Affiliation': 'Yale University, New Haven, Connecticut.'}, {'ForeName': 'Lee W', 'Initials': 'LW', 'LastName': 'Jones', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Campbell', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Michael N', 'Initials': 'MN', 'LastName': 'Pollak', 'Affiliation': 'McGill University, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Sorrentino', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Cartmel', 'Affiliation': 'Yale University, New Haven, Connecticut.'}, {'ForeName': 'Maura', 'Initials': 'M', 'LastName': 'Harrigan', 'Affiliation': 'Yale University, New Haven, Connecticut.'}, {'ForeName': 'Sara M', 'Initials': 'SM', 'LastName': 'Tolaney', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Eric P', 'Initials': 'EP', 'LastName': 'Winer', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Kimmie', 'Initials': 'K', 'LastName': 'Ng', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Abrams', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Sanft', 'Affiliation': 'Yale University, New Haven, Connecticut.'}, {'ForeName': 'Pamela S', 'Initials': 'PS', 'LastName': 'Douglas', 'Affiliation': 'Duke University, Durham, North Carolina.'}, {'ForeName': 'Frank B', 'Initials': 'FB', 'LastName': 'Hu', 'Affiliation': 'Harvard School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Charles S', 'Initials': 'CS', 'LastName': 'Fuchs', 'Affiliation': 'Yale University, New Haven, Connecticut.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Meyerhardt', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, Massachusetts.'}]","Cancer prevention research (Philadelphia, Pa.)",['10.1158/1940-6207.CAPR-20-0188']
2576,32865608,Introducing multiple-choice questions to promote learning for medical students: effect on exam performance in obstetrics and gynecology.,"PURPOSE


Testing is required in medical education. The large number of exams that students face requires effective learning strategies. Various methods of improving knowledge retention and recall have been discussed, two of the most widely evaluated of which are test-enhanced learning and pause procedures. This study investigated the effect of voluntary multiple-choice questions on students' performance.
METHODS


In a prospective study from April 2013 to March 2015, 721 students were randomly assigned to receive supplementary online material only (control group) or additional multiple-choice questions (investigative group) accompanying lectures. Their performance in the final exam was evaluated.
RESULTS


A total of 675 students were ultimately included, with 299 randomly assigned to the investigative group and 376 to the control group. Students in the investigative group scored significantly better in relation to grades and points (2.11 vs. 2.49; 33 vs 31.31; p < 0.05). The effect declined over time.
CONCLUSION


This is the first study of the use of voluntary multiple-choice questions to improve medical students' performance. The results support test-enhanced learning and the feasibility of implementing multiple-choice questions in lectures.",2020,Students in the investigative group scored significantly better in relation to grades and points (2.11 vs. 2.49; 33 vs 31.31; p < 0.05).,"['April 2013 to March 2015, 721 students', ""students' performance"", 'A total of 675 students were ultimately included, with 299 randomly assigned to the investigative group and 376 to the control group', 'medical students']","['supplementary online material only (control group) or additional multiple-choice questions (investigative group) accompanying lectures', 'voluntary multiple-choice questions']",[],"[{'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517854', 'cui_str': '675'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}]","[{'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}]",[],675.0,0.0204113,Students in the investigative group scored significantly better in relation to grades and points (2.11 vs. 2.49; 33 vs 31.31; p < 0.05).,"[{'ForeName': 'Sebastian M', 'Initials': 'SM', 'LastName': 'Jud', 'Affiliation': 'Department of Gynecology and Obstetrics, Erlangen University Hospital, Friedrich Alexander University of Erlangen-Nuremberg, Universitätsstrasse 21-23, 91054, Erlangen, Germany. sebastian.jud@uk-erlangen.de.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Cupisti', 'Affiliation': 'Department of Gynecology and Obstetrics, Erlangen University Hospital, Friedrich Alexander University of Erlangen-Nuremberg, Universitätsstrasse 21-23, 91054, Erlangen, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Frobenius', 'Affiliation': 'Department of Gynecology and Obstetrics, Erlangen University Hospital, Friedrich Alexander University of Erlangen-Nuremberg, Universitätsstrasse 21-23, 91054, Erlangen, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Winkler', 'Affiliation': 'Department of Gynecology and Obstetrics, Erlangen University Hospital, Friedrich Alexander University of Erlangen-Nuremberg, Universitätsstrasse 21-23, 91054, Erlangen, Germany.'}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Schultheis', 'Affiliation': 'Department of Gynecology and Obstetrics, Erlangen University Hospital, Friedrich Alexander University of Erlangen-Nuremberg, Universitätsstrasse 21-23, 91054, Erlangen, Germany.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Antoniadis', 'Affiliation': 'Department of Gynecology and Obstetrics, Erlangen University Hospital, Friedrich Alexander University of Erlangen-Nuremberg, Universitätsstrasse 21-23, 91054, Erlangen, Germany.'}, {'ForeName': 'Matthias W', 'Initials': 'MW', 'LastName': 'Beckmann', 'Affiliation': 'Department of Gynecology and Obstetrics, Erlangen University Hospital, Friedrich Alexander University of Erlangen-Nuremberg, Universitätsstrasse 21-23, 91054, Erlangen, Germany.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Heindl', 'Affiliation': 'Department of Gynecology and Obstetrics, Erlangen University Hospital, Friedrich Alexander University of Erlangen-Nuremberg, Universitätsstrasse 21-23, 91054, Erlangen, Germany.'}]",Archives of gynecology and obstetrics,['10.1007/s00404-020-05758-1']
2577,32865660,Qualitative Process Evaluation of Rural Schools: Uptake of Change Processes and Contextual Factors Influencing Implementation Within a Primary Prevention Program for Youth.,"Sexual violence (SV), homophobic name-calling, and bullying commonly occur in school settings. As such, comprehensive school-based violence prevention strategies are needed. Recent calls in prevention science argue that investigations of preventive interventions must move beyond simply testing if programs work; rather, they must also examine how interventions work. The purpose of this study was to explore the differential uptake of salient change mechanisms of a school-based primary prevention program, Sources of Strength (Sources) in rural schools, and examine contextual factors that may influence implementation outcomes in rural contexts. As a supplement to a randomized controlled trial of Sources in 20 high schools in Colorado, the present project utilized a rigorous qualitative design to conduct staff focus groups and student interviews within four schools (two intervention and two waitlist schools) that participated in the RCT. Results suggest variability in uptake of Sources key processes (expansion of networks to build connections, school-wide activities, and staff support) in intervention schools. While these were indicated as non-formalized processes in waitlist schools, there was also variability in these reports. Furthermore, results revealed specific contextual factors including cultural norms, degree of rurality, and school-level buy-in/investment that impacted implementation outcomes for intervention and waitlist schools (e.g., pre-implementation readiness). Implications are discussed around alignment of a school's policies, procedures, and values with the preventative intervention in effort to support strong implementation.",2020,"The purpose of this study was to explore the differential uptake of salient change mechanisms of a school-based primary prevention program, Sources of Strength (Sources) in rural schools, and examine contextual factors that may influence implementation outcomes in rural contexts.","['20 high schools in Colorado, the present project utilized a rigorous qualitative design to conduct staff focus groups and student interviews within four schools (two intervention and two waitlist schools) that participated in the RCT', 'rural schools', 'Rural Schools', 'rural contexts', 'Youth']","['school-based primary prevention program, Sources of Strength (Sources']","['specific contextual factors including cultural norms, degree of rurality, and school-level']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0009399', 'cui_str': 'Colorado'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0205556', 'cui_str': 'Qualitative'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0016400', 'cui_str': 'Focus Groups'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0449255', 'cui_str': 'Context'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0033144', 'cui_str': 'Primary prevention'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0449416', 'cui_str': 'Source'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0237750', 'cui_str': 'Societal Norms'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0036375', 'cui_str': 'School'}]",20.0,0.0175581,"The purpose of this study was to explore the differential uptake of salient change mechanisms of a school-based primary prevention program, Sources of Strength (Sources) in rural schools, and examine contextual factors that may influence implementation outcomes in rural contexts.","[{'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Yoder', 'Affiliation': 'School of Social Work, Colorado State University, Fort Collins, CO, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Williford', 'Affiliation': 'School of Social Work, Colorado State University, Fort Collins, CO, USA. anne.williford@colostate.edu.'}, {'ForeName': 'Lilyana', 'Initials': 'L', 'LastName': 'Ortega', 'Affiliation': 'Department of Human Development and Family Studies, Colorado State University, Fort Collins, CO, USA.'}, {'ForeName': 'Dorothy L', 'Initials': 'DL', 'LastName': 'Espelage', 'Affiliation': 'School of Education, University of North Carolina-Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'LoMurray', 'Affiliation': 'Sources of Strength, Lakewood, CO, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Ruiz', 'Affiliation': 'School of Social Work, Colorado State University, Fort Collins, CO, USA.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Kennedy', 'Affiliation': 'School of Social Work, Colorado State University, Fort Collins, CO, USA.'}]",Prevention science : the official journal of the Society for Prevention Research,['10.1007/s11121-020-01163-x']
2578,32867406,Training in statistical analysis reduces the framing effect among medical students and residents in Argentina.,"PURPOSE


The framing effect refers to a phenomenon wherein, when the same problem is presented using different representations of information, people make significant changes in their decisions. This study aimed to explore whether the framing effect could be reduced in medical students and residents by teaching them the statistical concepts of effect size, probability, and sampling for use in the medical decision-making process.
Methods


Ninety-five second-year medical students and 100 second-year medical residents of Austral University and Buenos Aires University, Argentina were invited to participate in the study between March and June 2017. A questionnaire was developed to assess the different types of framing effects in medical situations. After an initial administration of the survey, students and residents were taught statistical concepts including effect size, probability, and sampling during 2 individual independent official biostatistics courses. After these interventions, the same questionnaire was randomly administered again, and pre- and post-intervention outcomes were compared among students and residents.
RESULTS


Almost every type of framing effect was reproduced either in the students or in the residents. After teaching medical students and residents the analytical process behind statistical concepts, a significant reduction in sample-size, risky-choice, pseudo-certainty, number-size, attribute, goal, and probabilistic formulation framing effects was observed.
Conclusion


The decision-making of medical students and residents in simulated medical situations may be affected by different frame descriptions, and these framing effects can be partially reduced by training individuals in probability analysis and statistical sampling methods.",2020,Almost every type of framing effect was reproduced either in the students or in the resident population.,"['Austral University and Buenos Aires University, Argentina were invited to participate in the study between March and June 2017', 'Methods\n\n\nNinety-five second-year medical students and 100 second-year medical residentsof']",[],[],"[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C1741275', 'cui_str': 'AIRE protein, human'}, {'cui': 'C0003761', 'cui_str': 'Argentina'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4517906', 'cui_str': '95'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}]",[],[],,0.0258185,Almost every type of framing effect was reproduced either in the students or in the resident population.,"[{'ForeName': 'Raúl Alfredo', 'Initials': 'RA', 'LastName': 'Borracci', 'Affiliation': 'Biostatistics, School of Medicine, Austral University, Buenos Aires, Argentina.'}, {'ForeName': 'Eduardo Benigno', 'Initials': 'EB', 'LastName': 'Arribalzaga', 'Affiliation': 'Biostatistics, School of Medicine, Austral University, Buenos Aires, Argentina.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Thierer', 'Affiliation': 'School of Medicine, Buenos Aires University, Buenos Aires, Argentina.'}]",Journal of educational evaluation for health professions,['10.3352/jeehp.2020.17.25']
2579,32866432,"Carfilzomib or bortezomib in combination with lenalidomide and dexamethasone for patients with newly diagnosed multiple myeloma without intention for immediate autologous stem-cell transplantation (ENDURANCE): a multicentre, open-label, phase 3, randomised, controlled trial.","BACKGROUND


Bortezomib, lenalidomide, and dexamethasone (VRd) is a standard therapy for newly diagnosed multiple myeloma. Carfilzomib, a next-generation proteasome inhibitor, in combination with lenalidomide and dexamethasone (KRd), has shown promising efficacy in phase 2 trials and might improve outcomes compared with VRd. We aimed to assess whether the KRd regimen is superior to the VRd regimen in the treatment of newly diagnosed multiple myeloma in patients who were not being considered for immediate autologous stem-cell transplantation (ASCT).
METHODS


In this multicentre, open-label, phase 3, randomised controlled trial (the ENDURANCE trial; E1A11), we recruited patients aged 18 years or older with newly diagnosed multiple myeloma who were ineligible for, or did not intend to have, immediate ASCT. Participants were recruited from 272 community oncology practices or academic medical centres in the USA. Key inclusion criteria were the absence of high-risk multiple myeloma and an Eastern Cooperative Oncology Group performance status of 0-2. Enrolled patients were randomly assigned (1:1) centrally by use of permuted blocks to receive induction therapy with either the VRd regimen or the KRd regimen for 36 weeks. Patients who completed induction therapy were then randomly assigned (1:1) a second time to either indefinite maintenance or 2 years of maintenance with lenalidomide. Randomisation was stratified by intent for ASCT at disease progression for the first randomisation and by the induction therapy received for the second randomisation. Allocation was not masked to investigators or patients. For 12 cycles of 3 weeks, patients in the VRd group received 1·3 mg/m 2  of bortezomib subcutaneously or intravenously on days 1, 4, 8, and 11 of cycles 1-8, and day 1 and day 8 of cycles nine to twelve, 25 mg of oral lenalidomide on days 1-14, and 20 mg of oral dexamethasone on days 1, 2, 4, 5, 8, 9, 11, and 12. For nine cycles of 4 weeks, patients in the KRd group received 36 mg/m 2  of intravenous carfilzomib on days 1, 2, 8, 9, 15, and 16, 25 mg of oral lenalidomide on days 1-21, and 40 mg of oral dexamethasone on days 1, 8, 15, and 22. The coprimary endpoints were progression-free survival in the induction phase, and overall survival in the maintenance phase. The primary analysis was done in the intention-to-treat population and safety was assessed in patients who received at least one dose of their assigned treatment. The trial is registered with ClinicalTrials.gov, NCT01863550. Study recruitment is complete, and follow-up of the maintenance phase is ongoing.
FINDINGS


Between Dec 6, 2013, and Feb 6, 2019, 1087 patients were enrolled and randomly assigned to either the VRd regimen (n=542) or the KRd regimen (n=545). At a median follow-up of 9 months (IQR 5-23), at a second planned interim analysis, the median progression-free survival was 34·6 months (95% CI 28·8-37·8) in the KRd group and 34·4 months (30·1-not estimable) in the VRd group (hazard ratio [HR] 1·04, 95% CI 0·83-1·31; p=0·74). Median overall survival has not been reached in either group. The most common grade 3-4 treatment-related non-haematological adverse events included fatigue (34 [6%] of 527 patients in the VRd group vs 29 [6%] of 526 in the KRd group), hyperglycaemia (23 [4%] vs 34 [6%]), diarrhoea (23 [5%] vs 16 [3%]), peripheral neuropathy (44 [8%] vs four [<1%]), dyspnoea (nine [2%] vs 38 [7%]), and thromboembolic events (11 [2%] vs 26 [5%]). Treatment-related deaths occurred in two patients (<1%) in the VRd group (one cardiotoxicity and one secondary cancer) and 11 (2%) in the KRd group (four cardiotoxicity, two acute kidney failure, one liver toxicity, two respiratory failure, one thromboembolic event, and one sudden death).
INTERPRETATION


The KRd regimen did not improve progression-free survival compared with the VRd regimen in patients with newly diagnosed multiple myeloma, and had more toxicity. The VRd triplet regimen remains the standard of care for induction therapy for patients with standard-risk and intermediate-risk newly diagnosed multiple myeloma, and is a suitable treatment backbone for the development of combinations of four drugs.
FUNDING


US National Institutes of Health, National Cancer Institute, and Amgen.",2020,"The KRd regimen did not improve progression-free survival compared with the VRd regimen in patients with newly diagnosed multiple myeloma, and had more toxicity.","['Patients who completed induction therapy', '1087 patients', 'Participants were recruited from 272 community oncology practices or academic medical centres in the USA', 'patients with newly diagnosed multiple myeloma without intention for immediate autologous stem-cell transplantation (ENDURANCE', 'patients with standard-risk and intermediate-risk newly diagnosed multiple myeloma', 'newly diagnosed multiple myeloma in patients who were not being considered for immediate autologous stem-cell transplantation (ASCT', 'newly diagnosed multiple myeloma', 'patients aged 18 years or older with newly diagnosed multiple myeloma who were ineligible for, or did not intend to have, immediate ASCT']","['lenalidomide and dexamethasone', 'KRd', 'lenalidomide and dexamethasone (KRd', 'bortezomib', 'oral dexamethasone', 'indefinite maintenance or 2 years of maintenance with lenalidomide', 'VRd regimen', 'KRd regimen', 'intravenous carfilzomib', 'Carfilzomib or bortezomib', 'induction therapy with either the VRd regimen or the KRd regimen', 'oral lenalidomide', 'Bortezomib, lenalidomide, and dexamethasone (VRd']","['thromboembolic events', 'cardiotoxicity, two acute kidney failure, one liver toxicity, two respiratory failure, one thromboembolic event, and one sudden death', 'diarrhoea', 'intention-to-treat population and safety', 'deaths', 'progression-free survival in the induction phase, and overall survival', 'progression-free survival', 'toxicity', 'dyspnoea', 'median progression-free survival', 'Median overall survival', 'peripheral neuropathy', 'hyperglycaemia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C1831743', 'cui_str': 'Transplantation of autologous hematopoietic stem cell'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}]","[{'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C1176309', 'cui_str': 'bortezomib'}, {'cui': 'C0360528', 'cui_str': 'Dexamethasone-containing product in oral dose form'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C2001856', 'cui_str': 'carfilzomib'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0876994', 'cui_str': 'Cardiotoxicity'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C0011071', 'cui_str': 'Sudden death'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1869037', 'cui_str': 'Peripheral neuropathy (SMQ)'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}]",1087.0,0.211992,"The KRd regimen did not improve progression-free survival compared with the VRd regimen in patients with newly diagnosed multiple myeloma, and had more toxicity.","[{'ForeName': 'Shaji K', 'Initials': 'SK', 'LastName': 'Kumar', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA. Electronic address: kumar.shaji@mayo.edu.'}, {'ForeName': 'Susanna J', 'Initials': 'SJ', 'LastName': 'Jacobus', 'Affiliation': 'ECOG-ACRIN Biostatistics Center, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Adam D', 'Initials': 'AD', 'LastName': 'Cohen', 'Affiliation': 'Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Weiss', 'Affiliation': 'ThedaCare, Appleton, WI, USA.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Callander', 'Affiliation': 'University of Wisconsin Carbone Cancer Center, University of Wisconsin, Madison, WI, USA.'}, {'ForeName': 'Avina K', 'Initials': 'AK', 'LastName': 'Singh', 'Affiliation': 'MOHPA, Burnsville, MN, USA.'}, {'ForeName': 'Terri L', 'Initials': 'TL', 'LastName': 'Parker', 'Affiliation': 'Department of Hematology, Yale University, Hamden, CT, USA.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Menter', 'Affiliation': 'Kaiser Permanente Lone Tree, Lone Tree, CO, USA.'}, {'ForeName': 'Xuezhong', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Saint Francis Cancer Center, Greenville, NC, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Parsons', 'Affiliation': 'Gundersen Health System, La Crosse, WI, USA.'}, {'ForeName': 'Pankaj', 'Initials': 'P', 'LastName': 'Kumar', 'Affiliation': 'Illinois Cancer Care, Peoria, IL, USA.'}, {'ForeName': 'Prashant', 'Initials': 'P', 'LastName': 'Kapoor', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Rosenberg', 'Affiliation': 'University of California Davis Comprehensive Cancer Center, Sacramento, CA, USA.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Zonder', 'Affiliation': 'Department of Malignant Hematology, Barbara Ann Karmanos Cancer Institute and Wayne State University School of Medicine, Detroit, MI, USA.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Faber', 'Affiliation': 'Oncology Hematology Care, Cincinnati, OH, USA.'}, {'ForeName': 'Sagar', 'Initials': 'S', 'LastName': 'Lonial', 'Affiliation': 'Winship Cancer Institute of Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Kenneth C', 'Initials': 'KC', 'LastName': 'Anderson', 'Affiliation': 'Dana Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Paul G', 'Initials': 'PG', 'LastName': 'Richardson', 'Affiliation': 'Dana Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Robert Z', 'Initials': 'RZ', 'LastName': 'Orlowski', 'Affiliation': 'University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Lynne I', 'Initials': 'LI', 'LastName': 'Wagner', 'Affiliation': 'Wake Forest University Health Sciences, Winston-Salem, NC, USA.'}, {'ForeName': 'S Vincent', 'Initials': 'SV', 'LastName': 'Rajkumar', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30452-6']
2580,32869069,"Intubation Setting, Aspiration, and Ventilator-Associated Conditions.","BACKGROUND


Patients experience endotracheal intubation in various settings with wide-ranging risks for postintubation complications such as aspiration and ventilator-associated conditions.
OBJECTIVES


To evaluate associations between intubation setting, presence of aspiration biomarkers, and clinical outcomes.
METHODS


This study is a subanalysis of data from the NO-ASPIRATE single-blinded randomized clinical trial. Data were prospectively collected for 513 adult patients intubated within 24 hours of enrollment. Patients with documented aspiration events at intubation were excluded. In the NO-ASPIRATE trial, intervention patients received enhanced oropharyngeal suctioning every 4 hours and control patients received sham suctioning. Tracheal specimens for α-amylase and pepsin tests were collected upon enrollment. Primary outcomes were ventilator hours, lengths of stay, and rates of ventilator-associated conditions.
RESULTS


Of the baseline tracheal specimens, 76.4% were positive for α-amylase and 33.1% were positive for pepsin. Proportions of positive tracheal α-amylase and pepsin tests did not differ significantly between intubation locations (study hospital, transfer from other hospital, or field intubation). No differences were found for ventilator hours or lengths of stay. Patients intubated at another hospital and transferred had significantly higher ventilator-associated condition rates than did those intubated at the study hospital (P = .02). Ventilator-associated condition rates did not differ significantly between patients intubated in the field and patients in other groups.
CONCLUSIONS


Higher ventilator-associated condition rates associated with interhospital transfer may be related to movement from bed, vehicle loading and unloading, and transport vehicle vibrations. Airway assessment and care may also be suboptimal in the transport environment.",2020,Patients intubated at another hospital and transferred had significantly higher ventilator-associated condition rates than did those intubated at the study hospital (P = .02).,"['513 adult patients intubated within 24 hours of enrollment', 'Patients with documented aspiration events at intubation were excluded']",['enhanced oropharyngeal suctioning every 4 hours and control patients received sham suctioning'],"['ventilator-associated condition rates', 'ventilator hours or lengths of stay', 'Ventilator-associated condition rates', 'ventilator hours, lengths of stay, and rates of ventilator-associated conditions']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0004056', 'cui_str': 'Aspiration, Psychology'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}]","[{'cui': 'C0278384', 'cui_str': 'Oropharyngeal suctioning'}, {'cui': 'C0585324', 'cui_str': 'Every four hours'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0038638', 'cui_str': 'Suction drainage'}]","[{'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",513.0,0.174588,Patients intubated at another hospital and transferred had significantly higher ventilator-associated condition rates than did those intubated at the study hospital (P = .02).,"[{'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Talbert', 'Affiliation': 'Steven Talbert is an assistant clinical professor, Christine Wargo Detrick is a doctoral student, and Kimberly Emery is a doctoral candidate, University of Central Florida College of Nursing, Orlando, Florida.'}, {'ForeName': 'Christine Wargo', 'Initials': 'CW', 'LastName': 'Detrick', 'Affiliation': 'Steven Talbert is an assistant clinical professor, Christine Wargo Detrick is a doctoral student, and Kimberly Emery is a doctoral candidate, University of Central Florida College of Nursing, Orlando, Florida.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Emery', 'Affiliation': 'Steven Talbert is an assistant clinical professor, Christine Wargo Detrick is a doctoral student, and Kimberly Emery is a doctoral candidate, University of Central Florida College of Nursing, Orlando, Florida.'}, {'ForeName': 'Aurea', 'Initials': 'A', 'LastName': 'Middleton', 'Affiliation': 'Aurea Middleton is a clinical research coordinator, Orlando Regional Medical Center, Orlando, Florida.'}, {'ForeName': 'Bassam', 'Initials': 'B', 'LastName': 'Abomoelak', 'Affiliation': 'Bassam Abomoelak is a senior research associate and Chirajyoti Deb is a senior research scientist, Gastrointestinal Translational Laboratory, Arnold Palmer Hospital, Orlando Health, Orlando.'}, {'ForeName': 'Chirajyoti', 'Initials': 'C', 'LastName': 'Deb', 'Affiliation': 'Chirajyoti Deb is a senior research scientist, Gastrointestinal Translational Laboratory, Arnold Palmer Hospital, Orlando Health, Orlando.'}, {'ForeName': 'Devendra I', 'Initials': 'DI', 'LastName': 'Mehta', 'Affiliation': 'Devendra I. Mehta is an associate professor at Florida State University and director of the Gastrointestinal Translational Laboratory, Arnold Palmer Hospital for Children, Orlando Health.'}, {'ForeName': 'Mary Lou', 'Initials': 'ML', 'LastName': 'Sole', 'Affiliation': 'Mary Lou Sole is dean, Orlando Health Endowed Chair in Nursing, and University of Central Florida Pegasus Professor, University of Central Florida College of Nursing.'}]","American journal of critical care : an official publication, American Association of Critical-Care Nurses",['10.4037/ajcc2020129']
2581,32876780,Efficacy and safety results from a randomized double-blind study comparing proposed biosimilar ABP 798 with rituximab reference product in subjects with moderate-to-severe rheumatoid arthritis.,"BACKGROUND/OBJECTIVES


ABP 798 is a proposed biosimilar to the originator biologic rituximab, an anti-CD20 monoclonal antibody. This comparative clinical study evaluated the pharmacokinetics (PK), safety, and efficacy of ABP 798 versus rituximab reference product (RP) in patients with moderate-to-severe rheumatoid arthritis (RA).
METHODS


Adults with moderate-to-severe RA with an inadequate response or intolerance to other disease-modifying anti-rheumatic drugs including 1 or more tumor necrosis factor inhibitor therapies (n = 311) received ABP 798, US-sourced rituximab RP (rituximab US), or EU-sourced rituximab RP (rituximab EU) (1000 mg, 2 weeks apart). At week 24, ABP 798- or rituximab EU-treated subjects received a second dose of the same treatment, while rituximab US-treated subjects transitioned to receive ABP 798. The key efficacy endpoint was DAS28-CRP change from baseline at week 24. Other efficacy endpoints included DAS28-CRP at other time points; ACR20, ACR50, and ACR70 criteria; and hybrid ACR. The rituximab RP groups were pooled for all efficacy endpoints since PK equivalence had been established between rituximab US and rituximab EU.
RESULTS


Clinical equivalence between ABP 798 and rituximab RP was established as the 90% confidence interval for DAS28-CRP change from baseline at week 24 fell within the prespecified equivalence margin (- 0.6, 0.6). Safety and immunogenicity profiles of ABP 798 were comparable across treatment groups and not affected by single transition from RP to ABP 798.
CONCLUSIONS


Clinical equivalence in terms of efficacy, safety, and immunogenicity was established between ABP 798 and rituximab RP in this comparative clinical trial in patients with moderate-to-severe RA. Key Points • ABP 798 provided similar efficacy as rituximab reference product (RP) in patients with moderate-severe rheumatoid arthritis. • The safety and immunogenicity profiles for ABP 798 were similar to those for the rituximab RP. • The single transition from rituximab RP to ABP 798 did not show differences in efficacy, safety, or immunogenicity.",2020,"Safety and immunogenicity profiles of ABP 798 were comparable across treatment groups and not affected by single transition from RP to ABP 798.
","['patients with moderate-to-severe RA', 'patients with moderate-severe rheumatoid arthritis', 'Adults with moderate-to-severe RA with an inadequate response or intolerance to other disease-modifying anti-rheumatic drugs including 1 or more tumor necrosis factor inhibitor therapies (n\u2009=\u2009311) received', 'subjects with moderate-to-severe rheumatoid arthritis', 'patients with moderate-to-severe rheumatoid arthritis (RA']","['ABP 798 versus rituximab reference product (RP', 'biosimilar ABP 798 with rituximab reference product', 'rituximab US-treated subjects transitioned to receive ABP 798', 'ABP 798, US-sourced rituximab RP (rituximab US), or EU-sourced rituximab RP (rituximab EU']","['efficacy, safety, and immunogenicity', 'DAS28-CRP at other time points; ACR20, ACR50, and ACR70 criteria; and hybrid ACR', 'pharmacokinetics (PK), safety, and efficacy', 'Safety and immunogenicity profiles', 'Efficacy and safety', 'efficacy, safety, or immunogenicity', 'safety and immunogenicity profiles']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0231199', 'cui_str': 'Intolerance'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0003191', 'cui_str': 'Antirheumatic agent'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C3537192', 'cui_str': 'TNF Antagonists'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0001239', 'cui_str': 'Actin-binding protein'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C4045974', 'cui_str': 'Biosimilars'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}]",,0.0484735,"Safety and immunogenicity profiles of ABP 798 were comparable across treatment groups and not affected by single transition from RP to ABP 798.
","[{'ForeName': 'Gerd', 'Initials': 'G', 'LastName': 'Burmester', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Free University and Humboldt University Berlin, Charité-University Medicine Berlin, Charitéplatz 1, 10117, Berlin, Germany. gerd.burmester@charite.de.'}, {'ForeName': 'Edit', 'Initials': 'E', 'LastName': 'Drescher', 'Affiliation': 'Veszprém Csolnoky Ferenc County Hospital, Veszprém, Hungary.'}, {'ForeName': 'Pawel', 'Initials': 'P', 'LastName': 'Hrycaj', 'Affiliation': 'Rheumatology, Koscian Municipal Hospital, Koscian, Poland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Chien', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Zhiying', 'Initials': 'Z', 'LastName': 'Pan', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Cohen', 'Affiliation': 'Metroplex Clinical Research Center, Dallas, TX, USA.'}]",Clinical rheumatology,['10.1007/s10067-020-05305-y']
2582,32871336,Single dose testosterone administration modulates the temporal dynamics of distractor processing.,"Some evidence suggests that testosterone can increase attentional orientation toward biologically relevant stimuli and increase sustained attention during goal-oriented behaviors. While rare irregular distractors often capture attention involuntarily and distract us away from the task at hand, we hypothesized that testosterone might (1) facilitate attentional orientation to novel distractors that are of potential behavioral relevance and (2) inhibit information processing of distractors that are irrelevant to the task. To test this hypothesis, we investigated the effects of testosterone on distractor processing in a novelty oddball task, during which infrequent target and distractor sounds were interspersed within a series of frequent non-target sounds. Using a double-blind, placebo-controlled within-participant design, we administered a single dose of either testosterone or placebo to 34 healthy male volunteers and compared their electroencephalographic responses to distractors. Increased amplitude of the early (260-310 ms) P3 component-which has been associated with phasic arousal and alertness triggered by novel stimuli-was observed in the testosterone session than in the placebo session. This early-P3 response mediated the effect of testosterone administration on target hit rate during the task. In addition, less α-oscillation suppression-which has been associated with the inhibition of task-irrelevant information processing-was observed in response to distractors later (538-757 ms) in the testosterone session than in the placebo session. These results suggest that testosterone facilitated phasic arousal to novel distractors during the early-latency stage, which might have influenced behavioral performance during the task. Furthermore, testosterone inhibited task-irrelevant information processing during the late-latency stage, which allowed better reorientation of attention back to the primary task. Our findings highlight the role of testosterone in distractor processing, and provide a theoretical basis for treating attention-related behavioral disorders with hormone therapies.",2020,"Furthermore, testosterone inhibited task-irrelevant information processing during the late-latency stage, which allowed better reorientation of attention back to the primary task.",['34 healthy male volunteers'],"['placebo', 'testosterone', 'testosterone or placebo']",['temporal dynamics of distractor processing'],"[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}]","[{'cui': 'C0442043', 'cui_str': 'Temporal'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}]",34.0,0.311301,"Furthermore, testosterone inhibited task-irrelevant information processing during the late-latency stage, which allowed better reorientation of attention back to the primary task.","[{'ForeName': 'Huihua', 'Initials': 'H', 'LastName': 'Fang', 'Affiliation': 'School of Psychology, Shenzhen University, Shenzhen, Guangdong, China; Shenzhen Key Laboratory of Affective and Social Cognitive Science, Shenzhen University, Shenzhen, Guangdong, China; Department of Psychology, University of Mannheim, Mannheim, Germany.'}, {'ForeName': 'Xiaoyun', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'School of Psychology, Shenzhen University, Shenzhen, Guangdong, China.'}, {'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'School of Psychology, Shenzhen University, Shenzhen, Guangdong, China.'}, {'ForeName': 'Weiwei', 'Initials': 'W', 'LastName': 'Peng', 'Affiliation': 'School of Psychology, Shenzhen University, Shenzhen, Guangdong, China; Shenzhen Key Laboratory of Affective and Social Cognitive Science, Shenzhen University, Shenzhen, Guangdong, China. Electronic address: ww.peng0923@gmail.com.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104838']
2583,32871397,Neuromuscular training improves knee proprioception in athletes with a history of anterior cruciate ligament reconstruction: A randomized controlled trial.,"BACKGROUND


Athletes exhibit deficits in knee proprioception following anterior cruciate ligament reconstruction. Neuromuscular training programs improve knee proprioception in uninjured athletes; however, the effects on knee proprioception in athletes who have undergone anterior cruciate ligament reconstruction is not well understood. The purpose of this study was to examine the effects of a neuromuscular training program on knee proprioception in athletes who have returned to sport following anterior cruciate ligament reconstruction.
METHODS


Twenty-four male athletes, who had undergone anterior cruciate ligament reconstruction within the previous 6-12 months and returned to sport, participated in this randomized controlled trial. Athletes were randomly allocated to an experimental group (n = 12) that took part in an 8-week neuromuscular training program or a control group (n = 12) that simply continued their typical training routine. Knee position sense was assessed at baseline and after the 8-week period (post-testing). One-way analysis of covariance, with baseline performance included as a covariate, was used to compare knee position sense errors for the reconstructed limbs of the experimental and control groups at the post-testing time point.
FINDINGS


Knee position sense errors decreased by 51.7% for the experimental group and only 4.4% for the control group over the 8-week period. As a result, the experimental group demonstrated lower knee position sense errors, compared to the control group, at the post-testing time point (P < .001).
INTERPRETATION


Athletes with a history of anterior cruciate ligament reconstruction may benefit from participation in a neuromuscular training program, even after completing post-operative rehabilitation.",2020,"FINDINGS


Knee position sense errors decreased by 51.7% for the experimental group and only 4.4% for the control group over the 8-week period.","['athletes who have undergone anterior cruciate ligament reconstruction', 'Twenty-four male athletes, who had undergone anterior cruciate ligament reconstruction within the previous 6-12\xa0months and returned to sport', 'anterior cruciate ligament reconstruction', 'athletes who have returned to sport following anterior cruciate ligament reconstruction', 'athletes with a history of anterior cruciate ligament reconstruction', 'Athletes with a history of anterior cruciate ligament reconstruction', 'uninjured athletes']","['Neuromuscular training', 'neuromuscular training program', 'Neuromuscular training programs', 'neuromuscular training program or a control group (n\xa0=\xa012) that simply continued their typical training routine']","['lower knee position sense errors', 'knee proprioception', 'Knee position sense errors', 'Knee position sense']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4042817', 'cui_str': 'Return to Play'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0262926', 'cui_str': 'History of'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0234219', 'cui_str': 'Postural sense'}, {'cui': 'C0033499', 'cui_str': 'Proprioception'}]",24.0,0.0152322,"FINDINGS


Knee position sense errors decreased by 51.7% for the experimental group and only 4.4% for the control group over the 8-week period.","[{'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Ghaderi', 'Affiliation': 'Kharazmi University, No. 43, South Mofatteh Ave., Tehran 15719-14911, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Letafatkar', 'Affiliation': 'Kharazmi University, No. 43, South Mofatteh Ave., Tehran 15719-14911, Iran.'}, {'ForeName': 'Thomas Gus', 'Initials': 'TG', 'LastName': 'Almonroeder', 'Affiliation': 'University of Wisconsin - La Crosse, 1300 Badger St., La Crosse, WI 54601, United States. Electronic address: talmonroeder@uwlax.edu.'}, {'ForeName': 'Sohrab', 'Initials': 'S', 'LastName': 'Keyhani', 'Affiliation': 'Akhtar Hospital, Shahid Beheshti University of Medical Sciences, Velenjak St., Tehran 19857-17443, Iran.'}]","Clinical biomechanics (Bristol, Avon)",['10.1016/j.clinbiomech.2020.105157']
2584,32865376,Aspirin with or without Clopidogrel after Transcatheter Aortic-Valve Implantation.,"BACKGROUND


The effect of single as compared with dual antiplatelet treatment on bleeding and thromboembolic events after transcatheter aortic-valve implantation (TAVI) in patients who do not have an indication for long-term anticoagulation has not been well studied.
METHODS


In a randomized, controlled trial, we assigned a subgroup of patients who were undergoing TAVI and did not have an indication for long-term anticoagulation, in a 1:1 ratio, to receive aspirin alone or aspirin plus clopidogrel for 3 months. The two primary outcomes were all bleeding (including minor, major, and life-threatening or disabling bleeding) and non-procedure-related bleeding over a period of 12 months. Most bleeding at the TAVI puncture site was counted as non-procedure-related. The two secondary outcomes were a composite of death from cardiovascular causes, non-procedure-related bleeding, stroke, or myocardial infarction (secondary composite 1) and a composite of death from cardiovascular causes, ischemic stroke, or myocardial infarction (secondary composite 2) at 1 year, with both outcomes tested sequentially for noninferiority (noninferiority margin, 7.5 percentage points) and superiority.
RESULTS


A total of 331 patients were assigned to receive aspirin alone and 334 were assigned to receive aspirin plus clopidogrel. A bleeding event occurred in 50 patients (15.1%) receiving aspirin alone and in 89 (26.6%) receiving aspirin plus clopidogrel (risk ratio, 0.57; 95% confidence interval [CI], 0.42 to 0.77; P = 0.001). Non-procedure-related bleeding occurred in 50 patients (15.1%) and 83 patients (24.9%), respectively (risk ratio, 0.61; 95% CI, 0.44 to 0.83; P = 0.005). A secondary composite 1 event occurred in 76 patients (23.0%) receiving aspirin alone and in 104 (31.1%) receiving aspirin plus clopidogrel (difference, -8.2 percentage points; 95% CI for noninferiority, -14.9 to -1.5; P<0.001; risk ratio, 0.74; 95% CI for superiority, 0.57 to 0.95; P = 0.04). A secondary composite 2 event occurred in 32 patients (9.7%) and 33 patients (9.9%), respectively (difference, -0.2 percentage points; 95% CI for noninferiority, -4.7 to 4.3; P = 0.004; risk ratio, 0.98; 95% CI for superiority, 0.62 to 1.55; P = 0.93). A total of 44 patients (13.3%) and 32 (9.6%), respectively, received oral anticoagulation during the trial.
CONCLUSIONS


Among patients undergoing TAVI who did not have an indication for oral anticoagulation, the incidence of bleeding and the composite of bleeding or thromboembolic events at 1 year were significantly less frequent with aspirin than with aspirin plus clopidogrel administered for 3 months. (Funded by the Netherlands Organization for Health Research and Development; POPular TAVI EU Clinical Trials Register number, 2013-003125-28; ClinicalTrials.gov number, NCT02247128.).",2020,"Non-procedure-related bleeding occurred in 50 patients (15.1%) and 83 patients (24.9%), respectively (risk ratio, 0.61; 95% CI, 0.44 to 0.83; P = 0.005).","['for 3 months', '331 patients', 'patients who do not have an indication for long-term anticoagulation', '44 patients (13.3%) and 32 (9.6%), respectively, received oral anticoagulation during the trial', 'subgroup of patients who were undergoing TAVI and did not have an indication for long-term anticoagulation, in a 1:1 ratio, to receive', 'after Transcatheter Aortic-Valve Implantation']","['aspirin alone or aspirin plus clopidogrel', 'aspirin plus clopidogrel', 'aspirin alone', 'Aspirin with or without Clopidogrel', 'aspirin', 'transcatheter aortic-valve implantation (TAVI']","['incidence of bleeding and the composite of bleeding or thromboembolic events', 'all bleeding (including minor, major, and life-threatening or disabling bleeding) and non-procedure-related bleeding', 'bleeding and thromboembolic events', 'composite of death from cardiovascular causes, non-procedure-related bleeding, stroke, or myocardial infarction (secondary composite 1) and a composite of death from cardiovascular causes, ischemic stroke, or myocardial infarction (secondary composite 2', 'bleeding event', 'bleeding']","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C2711836', 'cui_str': 'Percutaneous replacement of aortic valve using fluoroscopic guidance'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C2711836', 'cui_str': 'Percutaneous replacement of aortic valve using fluoroscopic guidance'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",331.0,0.493064,"Non-procedure-related bleeding occurred in 50 patients (15.1%) and 83 patients (24.9%), respectively (risk ratio, 0.61; 95% CI, 0.44 to 0.83; P = 0.005).","[{'ForeName': 'Jorn', 'Initials': 'J', 'LastName': 'Brouwer', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (J. Brouwer, V.J.N., J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Center, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center (W.H., L.V., A.W.J.H.) and the Cardiovascular Research Institute Maastricht (A.W.J.H., J.M.B.), Maastricht, the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), Cardiovascular Center Aalst, Onze Lieve Vrouwe Clinic (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Vincent J', 'Initials': 'VJ', 'LastName': 'Nijenhuis', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (J. Brouwer, V.J.N., J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Center, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center (W.H., L.V., A.W.J.H.) and the Cardiovascular Research Institute Maastricht (A.W.J.H., J.M.B.), Maastricht, the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), Cardiovascular Center Aalst, Onze Lieve Vrouwe Clinic (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Ronak', 'Initials': 'R', 'LastName': 'Delewi', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (J. Brouwer, V.J.N., J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Center, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center (W.H., L.V., A.W.J.H.) and the Cardiovascular Research Institute Maastricht (A.W.J.H., J.M.B.), Maastricht, the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), Cardiovascular Center Aalst, Onze Lieve Vrouwe Clinic (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Renicus S', 'Initials': 'RS', 'LastName': 'Hermanides', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (J. Brouwer, V.J.N., J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Center, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center (W.H., L.V., A.W.J.H.) and the Cardiovascular Research Institute Maastricht (A.W.J.H., J.M.B.), Maastricht, the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), Cardiovascular Center Aalst, Onze Lieve Vrouwe Clinic (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Wouter', 'Initials': 'W', 'LastName': 'Holvoet', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (J. Brouwer, V.J.N., J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Center, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center (W.H., L.V., A.W.J.H.) and the Cardiovascular Research Institute Maastricht (A.W.J.H., J.M.B.), Maastricht, the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), Cardiovascular Center Aalst, Onze Lieve Vrouwe Clinic (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Christophe L F', 'Initials': 'CLF', 'LastName': 'Dubois', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (J. Brouwer, V.J.N., J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Center, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center (W.H., L.V., A.W.J.H.) and the Cardiovascular Research Institute Maastricht (A.W.J.H., J.M.B.), Maastricht, the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), Cardiovascular Center Aalst, Onze Lieve Vrouwe Clinic (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Frambach', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (J. Brouwer, V.J.N., J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Center, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center (W.H., L.V., A.W.J.H.) and the Cardiovascular Research Institute Maastricht (A.W.J.H., J.M.B.), Maastricht, the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), Cardiovascular Center Aalst, Onze Lieve Vrouwe Clinic (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'De Bruyne', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (J. Brouwer, V.J.N., J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Center, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center (W.H., L.V., A.W.J.H.) and the Cardiovascular Research Institute Maastricht (A.W.J.H., J.M.B.), Maastricht, the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), Cardiovascular Center Aalst, Onze Lieve Vrouwe Clinic (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Gert K', 'Initials': 'GK', 'LastName': 'van Houwelingen', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (J. Brouwer, V.J.N., J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Center, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center (W.H., L.V., A.W.J.H.) and the Cardiovascular Research Institute Maastricht (A.W.J.H., J.M.B.), Maastricht, the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), Cardiovascular Center Aalst, Onze Lieve Vrouwe Clinic (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Jan A S', 'Initials': 'JAS', 'LastName': 'Van Der Heyden', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (J. Brouwer, V.J.N., J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Center, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center (W.H., L.V., A.W.J.H.) and the Cardiovascular Research Institute Maastricht (A.W.J.H., J.M.B.), Maastricht, the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), Cardiovascular Center Aalst, Onze Lieve Vrouwe Clinic (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Toušek', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (J. Brouwer, V.J.N., J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Center, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center (W.H., L.V., A.W.J.H.) and the Cardiovascular Research Institute Maastricht (A.W.J.H., J.M.B.), Maastricht, the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), Cardiovascular Center Aalst, Onze Lieve Vrouwe Clinic (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'van der Kley', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (J. Brouwer, V.J.N., J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Center, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center (W.H., L.V., A.W.J.H.) and the Cardiovascular Research Institute Maastricht (A.W.J.H., J.M.B.), Maastricht, the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), Cardiovascular Center Aalst, Onze Lieve Vrouwe Clinic (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Buysschaert', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (J. Brouwer, V.J.N., J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Center, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center (W.H., L.V., A.W.J.H.) and the Cardiovascular Research Institute Maastricht (A.W.J.H., J.M.B.), Maastricht, the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), Cardiovascular Center Aalst, Onze Lieve Vrouwe Clinic (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Carl E', 'Initials': 'CE', 'LastName': 'Schotborgh', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (J. Brouwer, V.J.N., J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Center, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center (W.H., L.V., A.W.J.H.) and the Cardiovascular Research Institute Maastricht (A.W.J.H., J.M.B.), Maastricht, the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), Cardiovascular Center Aalst, Onze Lieve Vrouwe Clinic (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Bert', 'Initials': 'B', 'LastName': 'Ferdinande', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (J. Brouwer, V.J.N., J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Center, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center (W.H., L.V., A.W.J.H.) and the Cardiovascular Research Institute Maastricht (A.W.J.H., J.M.B.), Maastricht, the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), Cardiovascular Center Aalst, Onze Lieve Vrouwe Clinic (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Pim', 'Initials': 'P', 'LastName': 'van der Harst', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (J. Brouwer, V.J.N., J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Center, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center (W.H., L.V., A.W.J.H.) and the Cardiovascular Research Institute Maastricht (A.W.J.H., J.M.B.), Maastricht, the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), Cardiovascular Center Aalst, Onze Lieve Vrouwe Clinic (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Roosen', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (J. Brouwer, V.J.N., J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Center, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center (W.H., L.V., A.W.J.H.) and the Cardiovascular Research Institute Maastricht (A.W.J.H., J.M.B.), Maastricht, the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), Cardiovascular Center Aalst, Onze Lieve Vrouwe Clinic (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Peper', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (J. Brouwer, V.J.N., J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Center, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center (W.H., L.V., A.W.J.H.) and the Cardiovascular Research Institute Maastricht (A.W.J.H., J.M.B.), Maastricht, the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), Cardiovascular Center Aalst, Onze Lieve Vrouwe Clinic (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Frederick W F', 'Initials': 'FWF', 'LastName': 'Thielen', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (J. Brouwer, V.J.N., J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Center, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center (W.H., L.V., A.W.J.H.) and the Cardiovascular Research Institute Maastricht (A.W.J.H., J.M.B.), Maastricht, the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), Cardiovascular Center Aalst, Onze Lieve Vrouwe Clinic (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'Veenstra', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (J. Brouwer, V.J.N., J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Center, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center (W.H., L.V., A.W.J.H.) and the Cardiovascular Research Institute Maastricht (A.W.J.H., J.M.B.), Maastricht, the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), Cardiovascular Center Aalst, Onze Lieve Vrouwe Clinic (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Dean R P P', 'Initials': 'DRPP', 'LastName': 'Chan Pin Yin', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (J. Brouwer, V.J.N., J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Center, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center (W.H., L.V., A.W.J.H.) and the Cardiovascular Research Institute Maastricht (A.W.J.H., J.M.B.), Maastricht, the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), Cardiovascular Center Aalst, Onze Lieve Vrouwe Clinic (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Martin J', 'Initials': 'MJ', 'LastName': 'Swaans', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (J. Brouwer, V.J.N., J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Center, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center (W.H., L.V., A.W.J.H.) and the Cardiovascular Research Institute Maastricht (A.W.J.H., J.M.B.), Maastricht, the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), Cardiovascular Center Aalst, Onze Lieve Vrouwe Clinic (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Benno J W M', 'Initials': 'BJWM', 'LastName': 'Rensing', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (J. Brouwer, V.J.N., J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Center, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center (W.H., L.V., A.W.J.H.) and the Cardiovascular Research Institute Maastricht (A.W.J.H., J.M.B.), Maastricht, the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), Cardiovascular Center Aalst, Onze Lieve Vrouwe Clinic (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Arnoud W J', 'Initials': 'AWJ', 'LastName': ""van 't Hof"", 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (J. Brouwer, V.J.N., J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Center, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center (W.H., L.V., A.W.J.H.) and the Cardiovascular Research Institute Maastricht (A.W.J.H., J.M.B.), Maastricht, the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), Cardiovascular Center Aalst, Onze Lieve Vrouwe Clinic (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'Timmers', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (J. Brouwer, V.J.N., J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Center, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center (W.H., L.V., A.W.J.H.) and the Cardiovascular Research Institute Maastricht (A.W.J.H., J.M.B.), Maastricht, the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), Cardiovascular Center Aalst, Onze Lieve Vrouwe Clinic (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Johannes C', 'Initials': 'JC', 'LastName': 'Kelder', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (J. Brouwer, V.J.N., J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Center, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center (W.H., L.V., A.W.J.H.) and the Cardiovascular Research Institute Maastricht (A.W.J.H., J.M.B.), Maastricht, the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), Cardiovascular Center Aalst, Onze Lieve Vrouwe Clinic (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Pieter R', 'Initials': 'PR', 'LastName': 'Stella', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (J. Brouwer, V.J.N., J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Center, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center (W.H., L.V., A.W.J.H.) and the Cardiovascular Research Institute Maastricht (A.W.J.H., J.M.B.), Maastricht, the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), Cardiovascular Center Aalst, Onze Lieve Vrouwe Clinic (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Baan', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (J. Brouwer, V.J.N., J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Center, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center (W.H., L.V., A.W.J.H.) and the Cardiovascular Research Institute Maastricht (A.W.J.H., J.M.B.), Maastricht, the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), Cardiovascular Center Aalst, Onze Lieve Vrouwe Clinic (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Jurriën M', 'Initials': 'JM', 'LastName': 'Ten Berg', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (J. Brouwer, V.J.N., J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Center, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center (W.H., L.V., A.W.J.H.) and the Cardiovascular Research Institute Maastricht (A.W.J.H., J.M.B.), Maastricht, the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), Cardiovascular Center Aalst, Onze Lieve Vrouwe Clinic (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}]",The New England journal of medicine,['10.1056/NEJMoa2017815']
2585,31818632,The effectiveness of systematic pain assessment on critically ill patient outcomes: A randomised controlled trial.,"BACKGROUND


Evidence suggests that critically ill patients' pain may still be underestimated. Systematic approaches to pain assessment are of paramount importance for improving patients' outcomes.
OBJECTIVES


To investigate the effectiveness of a systematic approach to pain assessment on the incidence and intensity of pain and related clinical outcomes in critically ill patients.
METHODS


Randomized controlled study with consecutive critically ill patients allocated to either a standard care only or a systematic pain assessment group. The Behavioral Pain Scale (BPS) and the Critical Pain Observation Tool (C-POT) were completed twice daily for all participants. In the intervention group, clinicians were notified of pain scores. Linear Mixed Models (LMM) for the longitudinal effect of the intervention were employed.
RESULTS


A total of 117 patients were included (control: n=61; intervention: n2=56). The incidence of pain (C-POT >2) in the intervention group was significantly lower compared to the control group (p < .001). The intervention had a statistically significant effect on pain intensity (BPS, p = 0.01). The average total morphine equivalent dose in the intervention group was higher than in the control group (p = 0.045), as well as the average total dose of propofol (p = 0.027). There were no statistically significant differences in ICU mortality (23.4% vs 19.3%, p=0.38, odds ratio 0.82 [0.337-1.997]) and length of ICU stay (13.5, SD 11.1 vs 13.9, SD 9.5 days, p= 0.47).
CONCLUSION


Systematic pain assessment may be associated with a decrease in the intensity and incidence of pain and influence the pharmacological management of pain and sedation of critically ill patients.",2020,The incidence of pain (C-POT >2) in the intervention group was significantly lower compared to the control group (p < .001).,"['consecutive critically ill patients allocated to either a', ""critically ill patients' pain"", 'A total of 117 patients were included (control: n=61; intervention: n2=56', 'critically ill patient\xa0outcomes', 'critically ill patients']","['standard care only or a systematic pain assessment group', 'systematic pain assessment']","['intensity and incidence of pain', 'length of ICU stay', 'pain intensity', 'average total morphine equivalent dose', 'Behavioral Pain Scale (BPS) and the Critical Pain Observation Tool (C-POT', 'ICU mortality', 'incidence of\xa0pain', 'pain scores']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1274040', 'cui_str': 'Result'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0030198', 'cui_str': 'Pain assessment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",117.0,0.105054,The incidence of pain (C-POT >2) in the intervention group was significantly lower compared to the control group (p < .001).,"[{'ForeName': 'Evanthia', 'Initials': 'E', 'LastName': 'Georgiou', 'Affiliation': 'Εducation Sector, Nursing Services, Ministry of Health, 1 Prodromou & Chilonos Street 17, 1448 Nicosia, Cyprus.'}, {'ForeName': 'Lefkios', 'Initials': 'L', 'LastName': 'Paikousis', 'Affiliation': 'Improvast Analytical Services, 7 Arkadias, 1048, Nicosia Cyprus. Electronic address: lefkios@improvast.com.'}, {'ForeName': 'Ekaterini', 'Initials': 'E', 'LastName': 'Lambrinou', 'Affiliation': 'Department of Nursing, Cyprus University of Technology, 15, Vragadinou Str, 3041 Limassol, Cyprus. Electronic address: ekaterini.lambrinou@cut.ac.cy.'}, {'ForeName': 'Anastasios', 'Initials': 'A', 'LastName': 'Merkouris', 'Affiliation': 'Cyprus University of Technology, Faculty of Health Sciences, Department of Nursing, 15, Vragadinou St., Limassol 3041, Cyprus. Electronic address: anastasios.merkouris@cut.ac.cy.'}, {'ForeName': 'Elizabeth D E', 'Initials': 'EDE', 'LastName': 'Papathanassoglou', 'Affiliation': 'Faculty of Nursing, University of Alberta, 5-262 Edmonton Clinic Health Academy (ECHA), 11405-87th Ave. Edmonton, Alberta, T6G 1C9, Canada. Electronic address: papathan@ualberta.ca.'}]",Australian critical care : official journal of the Confederation of Australian Critical Care Nurses,['10.1016/j.aucc.2019.09.004']
2586,32866344,"Does Augmented Visual Feedback from Novel, Multicolored, Three-Dimensional-Printed Teeth Affect Dental Students' Acquisition of Manual Skills?","Although three-dimensional (3D) printing technology is increasingly used in dental education, its application regarding the provision of online visual augmented feedback has not been tested. Thus, this study aimed to: (1) develop two generations of multicolored 3D-printed teeth that provide visual augmented feedback for students conducting the cavity preparation process, (2) assess students' clinical performance after training on the 3D models, and (3) acquire student feedback. For the first-generation model, augmented feedback was obtained from five 3D-printed teeth models for five cavity preparation procedures. Each model comprised three layers printed in green, yellow, and red indicating whether preparation was acceptable, limited, or unacceptable, respectively. The study used a crossover design in which the experimental group trained on five multicolored models and 10 standard plastic teeth, and the control group trained on 15 standard plastic teeth. Students gave positive feedback of the methodology but complained about the printed material's hardness. Therefore, a second-generation model was developed: the model's occlusal plane was replaced with a harder printed acrylic material, and the experiment was repeated. During training, instructors provided external terminal feedback only for performance on standard plastic teeth. Manual grades for cavity preparations on standard plastic teeth were compared. No significant differences were found between the control and experimental groups in both generations' models. However, less instructor time was needed, and similar clinical results were obtained after training with both generations. Thus, multicolored 3D-printed teeth models promote self-learning during the process of acquiring manual skills and reduce student dependency on instructors.",2020,No significant differences were found between the control and experimental groups in both generations' models.,[],[],['instructor time'],[],[],"[{'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",15.0,0.0183217,No significant differences were found between the control and experimental groups in both generations' models.,"[{'ForeName': 'Diva', 'Initials': 'D', 'LastName': 'Lugassy', 'Affiliation': 'Department of Oral Biology, The Maurice and Gabriela Goldschleger School of Dental Medicine, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Yafi', 'Initials': 'Y', 'LastName': 'Levanon', 'Affiliation': 'Department of Occupational Therapy, The Stanley Steyer School of Health Professions, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Gal', 'Initials': 'G', 'LastName': 'Rosen', 'Affiliation': 'Department of Oral Rehabilitation, The Maurice and Gabriela Goldschleger School of Dental Medicine, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Shiri', 'Initials': 'S', 'LastName': 'Livne', 'Affiliation': 'Department of Oral Rehabilitation, The Maurice and Gabriela Goldschleger School of Dental Medicine, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Naama', 'Initials': 'N', 'LastName': 'Fridenberg', 'Affiliation': 'Department of Oral Rehabilitation, The Maurice and Gabriela Goldschleger School of Dental Medicine, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Pilo', 'Affiliation': 'Department of Oral Rehabilitation, The Maurice and Gabriela Goldschleger School of Dental Medicine, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Tamar', 'Initials': 'T', 'LastName': 'Brosh', 'Affiliation': 'Department of Oral Biology, The Maurice and Gabriela Goldschleger School of Dental Medicine, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}]",Anatomical sciences education,['10.1002/ase.2014']
2587,32882517,"Improving abnormal gait patterns by using a gait exercise assist robot (GEAR) in chronic stroke subjects: A randomized, controlled, pilot trial.","BACKGROUND


Although the Gait Exercise Assist Robot (GEAR) has been reported to effectively improve gait of hemiplegic patients, no study has investigated its use in chronic stroke patients. It is possible to facilitate gait reorganization by gait training with less compensation using the GEAR even in chronic stroke patients.
RESEARCH QUESTION


What are the effects of GEAR training on the abnormal gait patterns of chronic stroke subjects?
METHODS


Subjects were randomly assigned to either the GEAR group (n = 8) or the treadmill group (n = 11). Each group underwent 20 sessions (40 min/day, 5 days/week). The changes in the 10 types of abnormal gait patterns were evaluated using a three-dimensional motion analysis system and the Global Rating of Change (GRC) scale before and after the intervention, and at 1-month and 3-month follow-up assessment.
RESULTS


In the GEAR group, hip hiking at a 1-month follow-up assessment was markedly lesser than that before the intervention, and the excessive hip external rotation at 3-month follow-up assessment was notably lesser than that after the intervention, but the change in excessive hip external rotation was in the normal range. In the treadmill group, knee extensor thrust at a 1-month follow-up assessment was strikingly lesser than that before the intervention, but the difference was in the normal range. In the GEAR group, the GRC scale scores were considerably higher after the intervention, at a 1-month, and 3-month follow-up assessment than those before the intervention. But, in the treadmill group, only the GRC scale score at a 1-month follow-up assessment was visibly higher than that before the intervention.
SIGNIFICANCE


Gait training using the GEAR may be more effective than treadmill-training in improving the swing phase in chronic stroke subjects.",2020,"In the GEAR group, the GRC scale scores were considerably higher after the intervention, at a 1-month, and 3-month follow-up assessment than those before the intervention.","['chronic stroke patients', 'chronic stroke subjects', 'Subjects']","['GEAR', 'Gait Exercise Assist Robot (GEAR', 'GEAR training', 'gait exercise assist robot (GEAR', 'Gait training']","['excessive hip external rotation', 'hip hiking', 'Global Rating of Change (GRC) scale', 'GRC scale score', 'GRC scale scores']","[{'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}]","[{'cui': 'C0442802', 'cui_str': 'Excessive'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0231462', 'cui_str': 'External rotation'}, {'cui': 'C4255280', 'cui_str': 'Hiking'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0196297,"In the GEAR group, the GRC scale scores were considerably higher after the intervention, at a 1-month, and 3-month follow-up assessment than those before the intervention.","[{'ForeName': 'Tomoyuki', 'Initials': 'T', 'LastName': 'Ogino', 'Affiliation': 'Department of Rehabilitation, Hyogo College of Medicine Sasayama Medical Center, Japan. Electronic address: ogino0327@gmail.com.'}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Kanata', 'Affiliation': 'Department of Rehabilitation, Hyogo College of Medicine Sasayama Medical Center, Japan.'}, {'ForeName': 'Ryota', 'Initials': 'R', 'LastName': 'Uegaki', 'Affiliation': 'Department of Rehabilitation, Hyogo College of Medicine Sasayama Medical Center, Japan.'}, {'ForeName': 'Tatuya', 'Initials': 'T', 'LastName': 'Yamaguchi', 'Affiliation': 'Department of Rehabilitation, Hyogo College of Medicine Sasayama Medical Center, Japan.'}, {'ForeName': 'Katuhisa', 'Initials': 'K', 'LastName': 'Morisaki', 'Affiliation': 'Department of Rehabilitation, Hyogo College of Medicine Sasayama Medical Center, Japan.'}, {'ForeName': 'Shuhei', 'Initials': 'S', 'LastName': 'Nakano', 'Affiliation': 'Department of Rehabilitation, Hyogo College of Medicine Sasayama Medical Center, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Uchiyama', 'Affiliation': 'Department of Rehabilitation Medicine, Hyogo College of Medicine, Japan.'}, {'ForeName': 'Kazuhisa', 'Initials': 'K', 'LastName': 'Domen', 'Affiliation': 'Department of Rehabilitation Medicine, Hyogo College of Medicine, Japan.'}]",Gait & posture,['10.1016/j.gaitpost.2020.07.017']
2588,32871454,Difficulties in developmental follow-up of preterm neonates in a randomised-controlled trial of Bifidobacterium breve M16-V - Experience from Western Australia.,"BACKGROUND


Probiotics may be neuroprotective for preterm neonates due to their anti-inflammatory effects and ability to facilitate nutrition.
AIM


To assess long-term effects of early probiotic supplementation on neuropsychological development in preterm infants.
STUDY DESIGN


Follow up study.
SUBJECTS


Children at age 3 to 5 years who had participated as preterm infants (<33 week) in the randomised controlled trial.
OUTCOMES


Primary: Continuous early learning composite measure derived from the Mullen's Scale of Early Learning (MSEL). Other outcomes were assessed by the Developmental, Dimensional and Diagnostic Interview, Developmental NEuroPSYchological assessment-2nd Edition, Parental questionnaires using children's communication checklist-2nd edition, social responsiveness scale, and Vineland Adaptive Behavioural Scales-2nd edition.
MEASURES


Continuous scores derived from all the measures.
RESULTS


67 children of the 159 participants (42%) (Probiotic: 36/79, Placebo: 31/80) were followed-up for at least one neuropsychological assessment. All six assessments were completed in 18/31 (58.1%) of the control vs. 11/36 (30.6%) probiotic group children. Multivariable analysis of MSEL composite score showed no evidence of probiotic effect univariately, or after adjustment for gestation, intrauterine growth restriction, Apgar <7 at 5 min and age at assessment (adjusted mean effect in probiotic group: -2.7, 95% CI -8.5-3.0, p = 0.349).
CONCLUSION


There was no significant effect on neurodevelopment of children assessed at the age of 3 to 5 years who participated as preterm neonates in the RCT of B. breve M-16V. The validity of these results is limited by the reduced sample size due to high rate of loss to follow up.",2020,All six assessments were completed in 18/31 (58.1%) of the control vs. 11/36 (30.6%) probiotic group children.,"['preterm infants', 'Children at age 3 to 5\xa0years who had participated as preterm infants (<33\xa0week', 'preterm neonates', '67 children of the 159 participants (42', 'from Western Australia']","['early probiotic supplementation', 'Placebo', 'Bifidobacterium breve M16-V - Experience', 'M-16V']","[""Developmental, Dimensional and Diagnostic Interview, Developmental NEuroPSYchological assessment-2nd Edition, Parental questionnaires using children's communication checklist-2nd edition, social responsiveness scale, and Vineland Adaptive Behavioural Scales-2nd edition"", ""Mullen's Scale of Early Learning (MSEL""]","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0043128', 'cui_str': 'Western Australia'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0314975', 'cui_str': 'Bifidobacterium breve'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C3875061', 'cui_str': 'Developmental, dimensional and diagnostic interview'}, {'cui': 'C2987126', 'cui_str': 'NEPSY'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0013621', 'cui_str': 'Education'}]",159.0,0.215666,All six assessments were completed in 18/31 (58.1%) of the control vs. 11/36 (30.6%) probiotic group children.,"[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Agrawal', 'Affiliation': 'Neonatal Directorate, KEM Hospital for Women, 374 Bagot Road, Subiaco, WA, Australia. Electronic address: sachin.agrawal@health.wa.gov.au.'}, {'ForeName': 'C F', 'Initials': 'CF', 'LastName': 'Pestell', 'Affiliation': 'School of Psychological Science, University of WA, 35 Stirling Highway, Crawley, WA, 6009 Perth, Australia; Telethon Kids Institute, 15 Hospital Avenue, Nedlands, WA, 6009 Perth, Australia.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Granich', 'Affiliation': 'Telethon Kids Institute, 15 Hospital Avenue, Nedlands, WA, 6009 Perth, Australia.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Rao', 'Affiliation': 'School of Medicine, University of WA, 35 Stirling Highway, Crawley, WA, 6009 Perth, Australia; Neonatal Pediatrics, Perth Children Hospital, 15 Hospital Avenue, Nedlands, WA, 6009 Perth, Australia.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Nathan', 'Affiliation': 'School of Medicine, University of WA, 35 Stirling Highway, Crawley, WA, 6009 Perth, Australia; Women and Infants Research Foundation, King Edward Memorial Hospital for Women, 374, Bagot Road, Subiaco, Perth, WA, Australia.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Wray', 'Affiliation': 'Child Development Centre, 4/16 Rheola St, West Perth, WA 6005, Australia; School of Medicine, University of WA, 35 Stirling Highway, Crawley, WA, 6009 Perth, Australia.'}, {'ForeName': 'A J O', 'Initials': 'AJO', 'LastName': 'Whitehouse', 'Affiliation': 'Telethon Kids Institute, 15 Hospital Avenue, Nedlands, WA, 6009 Perth, Australia.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Patole', 'Affiliation': 'Neonatal Directorate, KEM Hospital for Women, 374 Bagot Road, Subiaco, WA, Australia; School of Medicine, University of WA, 35 Stirling Highway, Crawley, WA, 6009 Perth, Australia.'}]",Early human development,['10.1016/j.earlhumdev.2020.105165']
2589,32873496,The Protective Impact of Telemedicine on Persons With Dementia and Their Caregivers During the COVID-19 Pandemic.,"OBJECTIVES


Social distancing under the COVID-19 pandemic has restricted access to community services for older adults with neurocognitive disorder (NCD) and their caregivers. Telehealth is a viable alternative to face-to-face service delivery. Telephone calls alone, however, may be insufficient. Here, we evaluated whether supplementary telehealth via video-conferencing platforms could bring additional benefits to care-recipient with NCD and their spousal caregivers at home.
PARTICIPANTS


Sixty older adults NCD-and-caregiver dyads were recruited through an activity center.
DESIGN, INTERVENTION


The impact of additional services delivered to both care-recipient and caregiver through video conference (n = 30) was compared with telehealth targeted at caregivers by telephone only (n = 30), over 4 weeks in a pretest-post-test design. Interviews and questionnaires were conducted at baseline and study's end.
MEASUREMENTS, RESULTS


Supplementary telemedicine had averted the deterioration in the Montreal Cognitive Assessment evident in the telephone-only group (η p 2  = 0.50). It also reversed the falling trend in quality of life observed in the telephone only group (QoL-AD, η p 2  = 0.23). Varying degrees of improvements in physical and mental health (Short-Form 36 v2), perceived burden (Zarit Burden Interview Scale) and self-efficacy (Revised Caregiving Self-Efficacy Scale) were observed among caregivers in the video-conferencing group, which were absent in the telephone-only group (η p 2  = 0.23-0.51).
CONCLUSION


Telemedicine by video conference was associated with improved resilience and wellbeing to both people with NCD and their caregivers at home. The benefits were visible already after 4 weeks and unmatched by telephone alone. Video conference as the modus operandi of telehmedicine beyond the context of pandemic-related social distancing should be considered.",2020,"MEASUREMENTS, RESULTS


Supplementary telemedicine had averted the deterioration in the Montreal Cognitive Assessment evident in the telephone-only group (η p 2  = 0.50).","['Persons With Dementia and Their Caregivers During the COVID-19 Pandemic', 'Sixty older adults NCD-and-caregiver dyads were recruited through an activity center', 'older adults with neurocognitive disorder (NCD) and their caregivers']","['additional services delivered to both care-recipient and caregiver through video conference (n\u202f=\u202f30) was compared with telehealth targeted at caregivers by telephone', 'Telemedicine']","['physical and mental health', 'quality of life', 'burden (Zarit Burden Interview Scale) and self-efficacy (Revised Caregiving Self-Efficacy Scale', 'Montreal Cognitive Assessment']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0347984', 'cui_str': 'During'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1615608', 'cui_str': 'Pandemics'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C4041080', 'cui_str': 'Neurocognitive disorder'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0086047', 'cui_str': 'Conferences'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}]",60.0,0.061643,"MEASUREMENTS, RESULTS


Supplementary telemedicine had averted the deterioration in the Montreal Cognitive Assessment evident in the telephone-only group (η p 2  = 0.50).","[{'ForeName': 'Frank Ho-Yin', 'Initials': 'FH', 'LastName': 'Lai', 'Affiliation': 'Department of Rehabilitation Sciences (FHYL, DTHC), The Hong Kong Polytechnic University, Hong Kong, China. Electronic address: frank.hy.lai@polyu.edu.hk.'}, {'ForeName': 'Elaine Wai-Hung', 'Initials': 'EW', 'LastName': 'Yan', 'Affiliation': 'Occupational Therapy Department (EWHY), Kowloon Hospital, Hong Kong, China.'}, {'ForeName': 'Kathy Ka-Ying', 'Initials': 'KK', 'LastName': 'Yu', 'Affiliation': 'Salvation Army Hong Kong & Macau Command, Tai Po Multi-service Centre for Senior Citizen.'}, {'ForeName': 'Wing-Sze', 'Initials': 'WS', 'LastName': 'Tsui', 'Affiliation': ""Women's Welfare Club Western District, Hong Kong Chung Hok Elderly Centre, Hong Kong, China.""}, {'ForeName': 'Daniel Ting-Hoi', 'Initials': 'DT', 'LastName': 'Chan', 'Affiliation': 'Department of Rehabilitation Sciences (FHYL, DTHC), The Hong Kong Polytechnic University, Hong Kong, China.'}, {'ForeName': 'Benjamin K', 'Initials': 'BK', 'LastName': 'Yee', 'Affiliation': 'Department of Rehabilitation Sciences (FHYL, DTHC), The Hong Kong Polytechnic University, Hong Kong, China.'}]",The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry,['10.1016/j.jagp.2020.07.019']
2590,32876405,"Effects of oral premedication with tramadol, pregabalin or clonidine on shivering after spinal anaesthesia in patients undergoing hysteroscopic procedures.","BACKGROUND


Shivering is a common complication of neuraxial anaesthesia. We compared the efficacy of tramadol, clonidine and pregabalin in preventing post-spinal anaes-thesia shivering in hysteroscopic procedures.
METHODS


A prospective, randomized, triple-blind, controlled clinical trial involving 120 ASA I-II women, aged 18-60 years. The patients were randomly allocated to receive either oral clonidine 0.2 mg (group C), tramadol 100 mg (group T), pregabalin 150 mg (group P) or <i><i><i>placebo</i></i></i> (group O) 90 minutes before spinal anaesthesia. The body tempe-rature was monitored at the forehead and tympanic membrane. The primary outcome was the occurrence of perioperative shivering. The secondary outcomes were the side effects and meperidine requirements to treat shivering.
RESULTS


All groups had comparable demographic data. Group C showed the lowest incidence, severity and number of intraoperative and postoperative shivering attacks. The time to the first shivering attack was significantly longer in group C than the other groups and in group T than groups P and O. The severity of shivering attacks was comparable among groups C, T and P while being significantly lower than group O. Meperidine requirements were significantly lower in group C. Groups C, T and P had a significantly higher sedation score than group O. The incidences of dizziness, nausea and vomiting were highest in group T.
CONCLUSIONS


Tramadol, pregabalin and clonidine seem to be effective oral premedications to reduce the incidence, frequency and severity of post-spinal shivering but clonidine proved to be more effective and tolerable.",2020,The time to the first shivering attack was significantly longer in group C than the other groups and in group T than groups P and O.,"['120 ASA I-II women, aged 18-60 years', 'patients undergoing hysteroscopic procedures']","['oral clonidine', 'Tramadol, pregabalin and clonidine', 'tramadol, pregabalin or clonidine', 'clonidine', 'tramadol 100 mg (group T), pregabalin 150 mg (group P) or <i><i><i>placebo</i></i></i', 'tramadol, clonidine and pregabalin']","['dizziness, nausea and vomiting', 'severity of shivering attacks', 'side effects and meperidine requirements to treat shivering', 'occurrence of perioperative shivering', 'sedation score', 'lowest incidence, severity and number of intraoperative and postoperative shivering attacks', 'time to the first shivering attack']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0009014', 'cui_str': 'Clonidine'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0657912', 'cui_str': 'pregabalin'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0036669', 'cui_str': 'Group T'}, {'cui': 'C1648912', 'cui_str': 'pregabalin 150 MG [Lyrica]'}, {'cui': 'C0441849', 'cui_str': 'Group P'}]","[{'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0036973', 'cui_str': 'Shivering or rigors'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0025376', 'cui_str': 'Meperidine'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C1736186', 'cui_str': 'Postoperative shivering'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",120.0,0.0271275,The time to the first shivering attack was significantly longer in group C than the other groups and in group T than groups P and O.,"[{'ForeName': 'Khaled', 'Initials': 'K', 'LastName': 'Gaballah', 'Affiliation': 'Department of Anaesthesia, Faculty of Medicine, Menoufia University, Egypt.'}, {'ForeName': 'Sabry', 'Initials': 'S', 'LastName': 'Abdallah', 'Affiliation': 'Department of Anaesthesia, Faculty of Medicine, Menoufia University, Egypt.'}]",Anaesthesiology intensive therapy,['10.5114/ait.2020.97579']
2591,32876408,Negative results for ketamine use in severe acute bronchospasm: a randomised controlled trial.,"BACKGROUND


Ketamine has bronchodilation properties. The aim of the single-centre, evaluator-blinded, randomised clinical trial study was to evaluate whether continuous infusion of ketamine is associated with improvement in respiratory mechanics correlated with bronchospasm relief, as compared with continuous infusion of fentanyl.
METHODS


Adult patients submitted to invasive mechanical ventilation were included if they had an acute severe bronchospasm, due to status asthmaticus or COPD exacerbation. They were randomised to ketamine or a standard IV analgesia with fentanyl, both in bolus and continuous infusion. Measurements of respiratory mechanics (airway resistance - R<sub>smax</sub>, dynamic compliance - C<sub>dyn</sub> and intrinsic PEEP - PEEPi) both at baseline and 3 and 24 h after randomisation were performed. The main outcome of this study was to evaluate the improvement of R<sub>smax</sub> in 3 h of continuous infusion of the study drugs.
RESULTS


Ketamine use was not associated with greater reduction in R<sub>smax</sub> when compared with fentanyl, either after 3 h (0 cm H<sub>2</sub>O L-1 s-1 ± 6 vs. -3 cm H<sub>2</sub>O L-1 s-1 ± 7.7, respectively; P = 0.16) or after 24 h (-3 cm H<sub>2</sub>O L-1 s-1 ± 17 vs. -3.5 cm H<sub>2</sub>O L-1 s-1 ± 13.7, respectively; P = 0.73). Patients randomized to the ketamine group did not have better improvements in delta PEEPi as compared with fentanyl in 3 h (P = 0.77) or in 24 h (P = 0.72).
CONCLUSIONS


In this study, ketamine use was not associated with improvement in ventilatory variables associated with bronchospasm.",2020,"Patients randomized to the ketamine group did not have better improvements in delta PEEPi as compared with fentanyl in 3 h (P = 0.77) or in 24 h (P = 0.72).
","['Adult patients submitted to invasive mechanical ventilation were included if they had an acute severe bronchospasm, due to status asthmaticus or COPD exacerbation', 'severe acute bronchospasm']","['ketamine', 'Ketamine']","['respiratory mechanics (airway resistance - R<sub', 'delta PEEPi']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0006266', 'cui_str': 'Bronchospasm'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0038218', 'cui_str': 'Acute severe exacerbation of asthma'}, {'cui': 'C0740304', 'cui_str': 'COPD exacerbation'}, {'cui': 'C0741804', 'cui_str': 'Acute bronchospasm'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}]","[{'cui': 'C0035230', 'cui_str': 'Breathing Mechanics'}, {'cui': 'C0001884', 'cui_str': 'Airway Resistance'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0439097', 'cui_str': 'Delta'}]",,0.345728,"Patients randomized to the ketamine group did not have better improvements in delta PEEPi as compared with fentanyl in 3 h (P = 0.77) or in 24 h (P = 0.72).
","[{'ForeName': 'Wagner', 'Initials': 'W', 'LastName': 'Nedel', 'Affiliation': 'Intensive Care Unit, Grupo Hospitalar Conceição, Porto Alegre, Brazil.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Costa', 'Affiliation': 'Intensive Care Unit, Grupo Hospitalar Conceição, Porto Alegre, Brazil.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Mendez', 'Affiliation': 'Intensive Care Unit, Grupo Hospitalar Conceição, Porto Alegre, Brazil.'}, {'ForeName': 'Luiz', 'Initials': 'L', 'LastName': 'Marin', 'Affiliation': 'Intensive Care Unit, Grupo Hospitalar Conceição, Porto Alegre, Brazil.'}, {'ForeName': 'Taiani', 'Initials': 'T', 'LastName': 'Vargas', 'Affiliation': 'Intensive Care Unit, Grupo Hospitalar Conceição, Porto Alegre, Brazil.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Marques', 'Affiliation': 'Intensive Care Unit, Grupo Hospitalar Conceição, Porto Alegre, Brazil.'}]",Anaesthesiology intensive therapy,['10.5114/ait.2020.97765']
2592,32871529,"Changes in glenohumeral translation, electromyographic activity, and pressure-pain thresholds following sustained or oscillatory mobilizations in stiff and healthy shoulders: Results of a randomized, controlled laboratory trial.","STUDY DESIGN


Randomized Controlled Laboratory Study.
BACKGROUND


Posterior glide glenohumeral (GH) mobilizations are utilized to improve motion and decrease pain in patients with shoulder pathologies, thought to be due to capsular stretch and neurophysiologic effects. However, it remains unclear how different GH mobilizations influence mobility, rotator cuff (RC) activity, and pain processing, or if effects are different in stiff (≥15-degree loss of passive motion in any plane) rather than healthy shoulders.
OBJECTIVES


To compare the effects of oscillatory and sustained posterior GH mobilizations on translation, RC activity, and pressure pain threshold (PPT) in stiff and healthy shoulders.
METHODS


Eighty-eight participants, (44 control, 44 stiff shoulders) were randomly assigned to one of two mobilization conditions. Pre-post intervention measurements of PPT, GH translation via ultrasound imaging, and RC activity assessed via electromyography were performed. Sustained or oscillatory grade III posterior GH mobilizations were then provided to all participants. Data were analyzed using tests of difference and regression modeling.
RESULTS


Sustained glides (2.8 ± 3.3 mm) demonstrated significantly greater changes in translation compared to oscillatory glides (1.1 ± 3.9 mm), p = .028. Stiff shoulders demonstrated higher total RC activity than controls both pre (+24.51%, p = .004) and post-intervention (+23.10%, p = .01). Small changes in PPT occurred across all conditions, none reaching clinically meaningful levels.
CONCLUSION


Sustained mobilizations resulted in greater changes in GH translation. RC activity was higher in the stiff shoulder group, and remained higher post-intervention despite gains in GH translation, suggesting a mechanical rather than neurophysiologic effect. There was no meaningful difference in PPT between modes of mobilization.
LEVEL OF EVIDENCE


Therapy, Randomized Controlled Laboratory Study, Level 1b.",2020,"Stiff shoulders demonstrated higher total RC activity than controls both pre (+24.51%, p = .004) and post-intervention (+23.10%, p = .01).","['stiff and healthy shoulders', 'patients with shoulder pathologies', 'Eighty-eight participants, (44 control, 44 stiff shoulders']","['Posterior glide glenohumeral (GH) mobilizations', 'sustained or oscillatory mobilizations', 'oscillatory and sustained posterior GH mobilizations']","['glenohumeral translation, electromyographic activity, and pressure-pain thresholds', 'GH translation', 'RC activity', 'PPT, GH translation via ultrasound imaging, and RC activity assessed via electromyography', 'PPT', 'total RC activity', 'mobility, rotator cuff (RC) activity, and pain processing', 'translation, RC activity, and pressure pain threshold (PPT']","[{'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C4517898', 'cui_str': '88'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0241042', 'cui_str': 'Shoulder stiff'}]","[{'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0336966', 'cui_str': 'Gliding'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}]","[{'cui': 'C0040712', 'cui_str': 'Translations'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0085515', 'cui_str': 'Structure of rotator cuff including muscles and tendons'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",88.0,0.18114,"Stiff shoulders demonstrated higher total RC activity than controls both pre (+24.51%, p = .004) and post-intervention (+23.10%, p = .01).","[{'ForeName': 'Brian T', 'Initials': 'BT', 'LastName': 'Swanson', 'Affiliation': 'University of Hartford, West Hartford, CT, USA; University of New England, Portland, ME, USA. Electronic address: bswanson@Hartford.edu.'}, {'ForeName': 'J Adrienne', 'Initials': 'JA', 'LastName': 'McAuley', 'Affiliation': 'University of New England, Portland, ME, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Lawrence', 'Affiliation': 'University of New England, Portland, ME, USA.'}]",Musculoskeletal science & practice,['10.1016/j.msksp.2020.102243']
2593,32880105,Pharmacological interventions for antisocial personality disorder.,"BACKGROUND


Antisocial personality disorder (AsPD) is associated with rule-breaking, criminality, substance use, unemployment, relationship difficulties, and premature death. Certain types of medication (drugs) may help people with AsPD. This review updates a previous Cochrane review, published in 2010.
OBJECTIVES


To assess the benefits and adverse effects of pharmacological interventions for adults with AsPD.
SEARCH METHODS


We searched CENTRAL, MEDLINE, Embase, 13 other databases and two trials registers up to 5 September 2019. We also checked reference lists and contacted study authors to identify studies.
SELECTION CRITERIA


Randomised controlled trials in which adults (age 18 years and over) with a diagnosis of AsPD or dissocial personality disorder were allocated to a pharmacological intervention or placebo control condition.
DATA COLLECTION AND ANALYSIS


Four authors independently selected studies and extracted data. We assessed risk of bias and created 'Summary of findings tables' and assessed the certainty of the evidence using the GRADE framework. The primary outcomes were: aggression; reconviction; global state/global functioning; social functioning; and adverse events.
MAIN RESULTS


We included 11 studies (three new to this update), involving 416 participants with AsPD. Most studies (10/11) were conducted in North America. Seven studies were conducted exclusively in an outpatient setting, one in an inpatient setting, and one in prison; two studies used multiple settings. The average age of participants ranged from 28.6 years to 45.1 years (overall mean age 39.6 years). Participants were predominantly (90%) male. Study duration ranged from 6 to 24 weeks, with no follow-up period. Data were available from only four studies involving 274 participants with AsPD. All the available data came from unreplicated, single reports, and did not allow independent statistical analysis to be conducted. Many review findings were limited to descriptive summaries based on analyses carried out and reported by the trial investigators. No study set out to recruit participants on the basis of having AsPD; many participants presented primarily with substance abuse problems. The studies reported on four primary outcomes and six secondary outcomes. Primary outcomes were aggression (six studies) global/state functioning (three studies), social functioning (one study), and adverse events (seven studies). Secondary outcomes were leaving the study early (eight studies), substance misuse (five studies), employment status (one study), impulsivity (one study), anger (three studies), and mental state (three studies). No study reported data on the primary outcome of reconviction or the secondary outcomes of quality of life, engagement with services, satisfaction with treatment, housing/accommodation status, economic outcomes or prison/service outcomes.   Eleven different drugs were compared with placebo, but data for AsPD participants were only available for five comparisons. Three classes of drug were represented: antiepileptic; antidepressant; and dopamine agonist (anti-Parkinsonian) drugs. We considered selection bias to be unclear in 8/11 studies, attrition bias to be high in 7/11 studies, and performance bias to be low in 7/11 studies. Using GRADE, we rated the certainty of evidence for each outcome in this review as very low, meaning that we have very little confidence in the effect estimates reported. Phenytoin (antiepileptic) versus placebo One study (60 participants) reported very low-certainty evidence that phenytoin (300 mg/day), compared to placebo, may reduce the mean frequency of aggressive acts per week (phenytoin mean = 0.33, no standard deviation (SD) reported; placebo mean = 0.51, no SD reported) in male prisoners with aggression (skewed data) at endpoint (six weeks). The same study (60 participants) reported no evidence of difference between phenytoin and placebo in the number of participants reporting the adverse event of nausea during week one (odds ratio (OR) 1.00, 95% confidence interval (CI) 0.06 to 16.76; very low-certainty evidence). The study authors also reported that no important side effects were detectable via blood cell counts or liver enzyme tests (very low-certainty evidence). The study did not measure reconviction, global/state functioning or social functioning. Desipramine (antidepressant) versus placebo One study (29 participants) reported no evidence of a difference between desipramine (250 to 300 mg/day) and placebo on mean social functioning scores (desipramine = 0.19; placebo = 0.21), assessed with the family-social domain of the Addiction Severity Index (scores range from zero to one, with higher values indicating worse social functioning), at endpoint (12 weeks) (very low-certainty evidence). Neither of the studies included in this comparison measured the other primary outcomes: aggression; reconviction; global/state functioning; or adverse events. Nortriptyline (antidepressant) versus placebo One study (20 participants) reported no evidence of a difference between nortriptyline (25 to 75 mg/day) and placebo on mean global state/functioning scores (nortriptyline = 0.3; placebo = 0.7), assessed with the Symptom Check List-90 (SCL-90) Global Severity Index (GSI; mean of subscale scores, ranging from zero to four, with higher scores indicating greater severity of symptoms), at endpoint (six months) in men with alcohol dependency (very low-certainty evidence). The study measured side effects but did not report data on adverse events for the AsPD subgroup. The study did not measure aggression, reconviction or social functioning. Bromocriptine (dopamine agonist) versus placebo One study (18 participants) reported no evidence of difference between bromocriptine (15 mg/day) and placebo on mean global state/functioning scores (bromocriptine = 0.4; placebo = 0.7), measured with the GSI of the SCL-90 at endpoint (six months) (very low-certainty evidence). The study did not provide data on adverse effects, but reported that 12 patients randomised to the bromocriptine group experienced severe side effects, five of whom dropped out of the study in the first two days due to nausea and severe flu-like symptoms (very low-certainty evidence). The study did not measure aggression, reconviction and social functioning. Amantadine (dopamine agonist) versus placebo The study in this comparison did not measure any of the primary outcomes.
AUTHORS' CONCLUSIONS


The evidence summarised in this review is insufficient to draw any conclusion about the use of pharmacological interventions in the treatment of antisocial personality disorder. The evidence comes from single, unreplicated studies of mostly older medications. The studies also have methodological issues that severely limit the confidence we can draw from their results. Future studies should recruit participants on the basis of having AsPD, and use relevant outcome measures, including reconviction.",2020,Neither of the studies included in this comparison measured the other primary outcomes: aggression; reconviction; global/state functioning; or adverse events.,"['274 participants with AsPD', 'Embase, 13 other databases and two trials registers up to 5 September 2019', '416 participants with AsPD', 'Most studies (10/11) were conducted in North America', 'antisocial personality disorder', 'Participants were predominantly (90%) male', 'Seven studies were conducted exclusively in an outpatient setting, one in an inpatient setting, and one in prison; two studies used multiple settings', 'people with AsPD', 'participants presented primarily with substance abuse problems', 'adults with AsPD', 'The average age of participants ranged from 28.6 years to 45.1 years (overall mean age 39.6 years', 'adults (age 18 years and over) with a diagnosis of AsPD or dissocial personality disorder']","['Nortriptyline (antidepressant) versus placebo', 'Bromocriptine (dopamine agonist', 'Phenytoin (antiepileptic', 'pharmacological interventions', 'desipramine', 'bromocriptine', 'pharmacological intervention or placebo control condition', 'Pharmacological interventions', 'Desipramine (antidepressant) versus placebo', 'placebo', 'dopamine agonist (anti-Parkinsonian) drugs', 'phenytoin and placebo', 'phenytoin', 'nortriptyline', 'Amantadine (dopamine agonist']","['aggression; reconviction; global/state functioning; or adverse events', 'adverse event of nausea', 'aggression, reconviction and social functioning', 'blood cell counts or liver enzyme tests', 'aggression, reconviction or social functioning', 'reconviction, global/state functioning or social functioning', 'severe side effects', 'aggression; reconviction; global state/global functioning; social functioning; and adverse events', 'adverse events', 'mean frequency of aggressive acts', 'mean social functioning scores', 'mean global state/functioning scores', 'Symptom Check List-90 (SCL-90) Global Severity Index (GSI', 'aggression (six studies) global/state functioning (three studies), social functioning (one study), and adverse events', 'adverse effects', 'family-social domain of the Addiction Severity Index (scores range', 'leaving the study early (eight studies), substance misuse (five\xa0studies), employment status (one study), impulsivity (one study), anger (three studies), and\xa0mental state', 'mean of subscale scores', 'quality of life, engagement with services, satisfaction with treatment, housing/accommodation\xa0status, economic outcomes or prison/service outcomes', 'nausea and severe flu-like symptoms']","[{'cui': 'C0003431', 'cui_str': 'Antisocial personality disorder'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0392751', 'cui_str': 'In prison'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0740858', 'cui_str': 'Substance abuse'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C4517679', 'cui_str': '28.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0028420', 'cui_str': 'Nortriptyline'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006230', 'cui_str': 'Bromocriptine'}, {'cui': 'C0178601', 'cui_str': 'Dopamine receptor agonist'}, {'cui': 'C0031507', 'cui_str': 'Phenytoin'}, {'cui': 'C0003299', 'cui_str': 'ANTIEPILEPTICS'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0011685', 'cui_str': 'Desipramine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0002403', 'cui_str': 'Amantadine'}]","[{'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0005771', 'cui_str': 'Blood cell count'}, {'cui': 'C0428321', 'cui_str': 'Measurement of liver enzyme'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1283174', 'cui_str': 'Checking - action'}, {'cui': 'C0378781', 'cui_str': 'Oncogene protein TAL 1'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C0242271', 'cui_str': 'Employment status'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0450981', 'cui_str': 'Addiction severity index'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0021125', 'cui_str': 'Impulsive behaviour'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C0278060', 'cui_str': 'Mental state'}, {'cui': 'C0459443', 'cui_str': 'Subscale score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C0557202', 'cui_str': 'Residence and accommodation circumstances'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0033168', 'cui_str': 'Prisons'}, {'cui': 'C0392171', 'cui_str': 'Influenza-like symptoms'}]",416.0,0.529666,Neither of the studies included in this comparison measured the other primary outcomes: aggression; reconviction; global/state functioning; or adverse events.,"[{'ForeName': 'Najat R', 'Initials': 'NR', 'LastName': 'Khalifa', 'Affiliation': ""Department of Psychiatry, Queen's University, Kingston, Canada.""}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Gibbon', 'Affiliation': 'Arnold Lodge, Nottinghamshire Healthcare NHS Foundation Trust, Leicester, UK.'}, {'ForeName': 'Birgit A', 'Initials': 'BA', 'LastName': 'Völlm', 'Affiliation': 'Department of Forensic Psychiatry, Center for Neurology, University Rostock, Rostock, Germany.'}, {'ForeName': 'Natalie H-Y', 'Initials': 'NH', 'LastName': 'Cheung', 'Affiliation': 'Forensic Research, Nottinghamshire Healthcare NHS Foundation Trust, Leicester, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'McCarthy', 'Affiliation': 'Arnold Lodge, Nottinghamshire Healthcare NHS Foundation Trust, Leicester, UK.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD007667.pub3']
2594,32877722,Characteristics of contents in the upper gastrointestinal lumen after a standard high-calorie high-fat meal and implications for the in vitro drug product performance testing conditions.,"OBJECTIVES


To measure the pH, buffer capacity, lipid content, bile acid content, and viscosity in the upper gastrointestinal (GI) lumen after a standard high-calorie, high-fat meal as well as the osmolality, lipid content and bile acid content in the aqueous phase of the gastric contents and the micellar phase of contents of the upper small intestine. To evaluate the implications of these findings for the composition of biorelevant media employed in vitro oral drug product performance testing representing the upper GI conditions after ingestion of the standard meal.
METHODS


Eight healthy male adult volunteers participated in a two-phase, crossover study in which a homogenized standard meal was administered to the antrum via the gastric port of a naso-gastro-intestinal tube. A glass of tap water and single paracetamol and danazol doses were administered to the antrum of the stomach 30 min after the initiation of meal administration (Pentafragka et al., 2020). Samples were aspirated from the antrum and the upper small intestine over the next four hours. The pH and the buffer capacity of the samples were measured immediately upon aspiration, while viscosity, osmolality, and presence of solubilizing agents were measured after storage at -70 °C.
RESULTS


The composition of gastric contents over time fluctuated less after the homogenized standard meal than after liquid meals with similar composition. Intra-subject variability of pH and buffer capacity in the stomach and in the upper small intestine was low. Mean viscosity values in the stomach at 100 s -1  were 80-800 times higher than in the fasted state for more than 3 h after the standard meal. In the upper small intestine, mean viscosity values at 100 s -1  were at least 100 times higher than in the fasted state for 4 h after the standard meal.
CONCLUSIONS


Based on data collected in this study, Level I and Level II biorelevant media simulating the intragastric conditions after ingestion of a standard meal could be simplified whereas FeSSIF-V2 composition was confirmed to be representative of the composition of contents in the upper small intestine. Representative values of viscosity in the stomach and the upper small intestine and Level II composition of the aqueous phase of gastric contents, after the standard meal, are proposed for first time.",2020,Intra-subject variability of pH and buffer capacity in the stomach and in the upper small intestine was low.,['Eight healthy male adult volunteers'],"['homogenized standard meal', 'paracetamol and danazol']","['Mean viscosity values', 'mean viscosity values', 'viscosity, osmolality, and presence of solubilizing agents', 'pH, buffer capacity, lipid content, bile acid content, and viscosity in the upper gastrointestinal (GI) lumen']","[{'cui': 'C0686751', 'cui_str': 'Well male adult'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0444664', 'cui_str': 'Standard meal'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0010961', 'cui_str': 'Danazol'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0042784', 'cui_str': 'Viscosity'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0086741', 'cui_str': 'Osmolality'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0006353', 'cui_str': 'Buffers'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0005390', 'cui_str': 'Bile acid'}, {'cui': 'C3203348', 'cui_str': 'Upper gastrointestinal tract structure'}, {'cui': 'C0524461', 'cui_str': 'Structure of lumen of body system'}]",8.0,0.0385476,Intra-subject variability of pH and buffer capacity in the stomach and in the upper small intestine was low.,"[{'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Pentafragka', 'Affiliation': 'Department of Pharmacy, National and Kapodistrian University of Athens, Panepistimiopolis, 15784 Zografou, Greece.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Vertzoni', 'Affiliation': 'Department of Pharmacy, National and Kapodistrian University of Athens, Panepistimiopolis, 15784 Zografou, Greece.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Dressman', 'Affiliation': 'Goethe University, Frankfurt/Main, Germany.'}, {'ForeName': 'Mira', 'Initials': 'M', 'LastName': 'Symillides', 'Affiliation': 'Department of Pharmacy, National and Kapodistrian University of Athens, Panepistimiopolis, 15784 Zografou, Greece.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Goumas', 'Affiliation': 'Department of Gastroenterology, Red Cross Hospital of Athens, Athens, Greece.'}, {'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Reppas', 'Affiliation': 'Department of Pharmacy, National and Kapodistrian University of Athens, Panepistimiopolis, 15784 Zografou, Greece. Electronic address: reppas@pharm.uoa.gr.'}]",European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences,['10.1016/j.ejps.2020.105535']
2595,32877791,"Parents as Teachers: Mothers' Roles in Sexual Abuse Prevention Education in Gorgan, Iran.","BACKGROUND


Parents play an important role in protecting their children from sexual abuse. Mothers, in particular, play key roles in the sexual socialization of their children and in educating their children about child sexual abuse (CSA).
OBJECTIVES


The purpose of this study was to determine whether preschool girls in Gorgan (a city in northern Iran) could learn personal safety skills when taught by their mothers.
PARTICIPANTS AND SETTING


Fifty-six participants (mother-daughter pairs) were recruited from patients visiting health centers. Mean age of girls was 6.34 years.
METHODS


Girls were pretested using Persian versions of the Personal Safety Questionnaire and 'What If' Situations Test, randomly assigned to either a mother-taught program or wait-list control, and post-tested. Mothers assigned to the education group participated in a two-hour workshop on preventing CSA and were given the Body Safety Training workbook to teach their daughters. Following the one-week training by their mothers, children in both groups were post-tested and follow-up tested one month later.
RESULTS


Children taught by their mothers demonstrated significant increases in knowledge about sexual abuse and higher levels of personal safety skills compared to controls, and these gains were maintained at the one-month follow-up.
CONCLUSION


Results suggest that mothers can effectively teach their young daughters personal safety skills. Difficulties female children have in recognizing appropriate-touch requests are discussed and compared to results in other developing countries. Advantages of home-based instruction for young children are described and suggestions for increasing parent participation are offered.",2020,"RESULTS


Children taught by their mothers demonstrated significant increases in knowledge about sexual abuse and higher levels of personal safety skills compared to controls, and these gains were maintained at the one-month follow-up.
","[""Mothers' Roles in Sexual Abuse Prevention Education in Gorgan, Iran"", 'Mean age of girls was 6.34 years', 'Difficulties female children', 'Fifty-six participants (mother-daughter pairs) were recruited from patients visiting health centers', 'young children', 'Parents as Teachers', 'Girls', 'preschool girls in Gorgan (a city in northern Iran']","['home-based instruction', 'mother-taught program or wait-list control, and post-tested']",['knowledge about sexual abuse and higher levels of personal safety skills'],"[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0282350', 'cui_str': 'Sexual abuse'}, {'cui': 'C1633748', 'cui_str': 'Prevention education'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0870604', 'cui_str': 'Female child'}, {'cui': 'C0011011', 'cui_str': 'Daughter'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0008848', 'cui_str': 'Cities'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0282350', 'cui_str': 'Sexual abuse'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",56.0,0.0148705,"RESULTS


Children taught by their mothers demonstrated significant increases in knowledge about sexual abuse and higher levels of personal safety skills compared to controls, and these gains were maintained at the one-month follow-up.
","[{'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Khoori', 'Affiliation': 'Counselling and Reproductive Health Research Centre, Golestan University of Medical Sciences, Gorgan, Iran. Electronic address: elhamkhoori@yahoo.com.'}, {'ForeName': 'Somayeh', 'Initials': 'S', 'LastName': 'Gholamfarkhani', 'Affiliation': 'Department of Obstetrics and Gynecology, Shohada Hospital of Quchan, Mashhad University of Medical Sciences, Quchan, Iran. Electronic address: somayeh.farkhani@gmail.com.'}, {'ForeName': 'Mahin', 'Initials': 'M', 'LastName': 'Tatari', 'Affiliation': 'Counselling and Reproductive Health Research Centre, Golestan University of Medical Sciences, Gorgan, Iran. Electronic address: maisa.tatari@yahoo.com.'}, {'ForeName': 'Sandy K', 'Initials': 'SK', 'LastName': 'Wurtele', 'Affiliation': 'Department of Psychology, University of Colorado, Colorado Springs, USA. Electronic address: swurtele@uccs.edu.'}]",Child abuse & neglect,['10.1016/j.chiabu.2020.104695']
2596,32886178,Pharmacokinetics and pharmacodynamics of intranasal remimazolam-a randomized controlled clinical trial.,"PURPOSE


Remimazolam is a novel and ultra-short-acting sedative currently developed for intravenous use in procedural sedation, general anesthesia, and ICU sedation. However, intravenous administration is not always appropriate, depending on the patient or setting. This study evaluated intranasal administration as a potential alternative route.
METHODS


The study used a randomized, double-blind, 9 period cross-over design to compare the pharmacokinetics, pharmacodynamics, and safety of single intranasal doses of 10, 20, and 40 mg remimazolam (as powder or solution) with intranasal placebo and 4 mg intravenous remimazolam.
RESULTS


Intranasal remimazolam powder had a consistent absolute bioavailability of approximately 50%; T max  was 10 min; AUC and C max  were dose-proportional. The higher doses of intranasal solution, however, resulted in decreasing bioavailability and loss of dose-proportionality in AUC and C max  despite complete drug absorption due to partial swallowing of dose and the resulting first-pass effect. Pharmacodynamics were generally consistent with PK. Peak effects (drowsiness, relaxation, any, memory, response time) were in similar ranges after intranasal (10 to 40 mg) as intravenous (4 mg) dosing and were partially, but not consistently, dose-related. Safety results were generally consistent with other benzodiazepines; however, intranasal remimazolam (but not placebo) caused nasal discomfort/pain, in some cases even severe.
CONCLUSIONS


Intranasal administration of remimazolam was safe and caused sedative effects. However, the severe pain and discomfort caused by intranasal remimazolam prohibit its use by this route of administration, at least with the currently available intravenous formulation.",2020,"RESULTS


Intranasal remimazolam powder had a consistent absolute bioavailability of approximately 50%; T max  was 10 min; AUC and C max  were dose-proportional.",[],"['intranasal remimazolam', 'benzodiazepines', 'remimazolam (as powder or solution) with intranasal placebo and 4\xa0mg intravenous remimazolam', 'remimazolam', 'placebo', 'Remimazolam']","['Peak effects (drowsiness, relaxation, any, memory, response time', 'pharmacokinetics, pharmacodynamics, and safety', 'absolute bioavailability', 'nasal discomfort/pain', 'severe pain and discomfort', 'safe and caused sedative effects', 'bioavailability and loss of dose-proportionality in AUC and C max']",[],"[{'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C3179470', 'cui_str': 'remimazolam'}, {'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0858259', 'cui_str': 'Nasal discomfort'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0278140', 'cui_str': 'Severe pain'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C3179159', 'cui_str': 'Sedative Effects'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}]",,0.185135,"RESULTS


Intranasal remimazolam powder had a consistent absolute bioavailability of approximately 50%; T max  was 10 min; AUC and C max  were dose-proportional.","[{'ForeName': 'Marija', 'Initials': 'M', 'LastName': 'Pesic', 'Affiliation': 'PAION Deutschland GmbH, Martinstr. 10-12, 52062, Aachen, Germany. m.pesic@paion.com.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Schippers', 'Affiliation': 'PAION Deutschland GmbH, Martinstr. 10-12, 52062, Aachen, Germany.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Saunders', 'Affiliation': 'PAION Deutschland GmbH, Martinstr. 10-12, 52062, Aachen, Germany.'}, {'ForeName': 'Lyn', 'Initials': 'L', 'LastName': 'Webster', 'Affiliation': 'Early Development Services, Scientific Affairs, PRA Health Sciences, Salt Lake City, UT, USA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Donsbach', 'Affiliation': 'PAION Deutschland GmbH, Martinstr. 10-12, 52062, Aachen, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Stoehr', 'Affiliation': 'PAION Deutschland GmbH, Martinstr. 10-12, 52062, Aachen, Germany.'}]",European journal of clinical pharmacology,['10.1007/s00228-020-02984-z']
2597,32881945,"Effect of complementary feeding behavior change communication delivered through community-level actors on dietary adequacy of infants in rural communities of West Gojjam Zone, Northwest Ethiopia: A cluster-randomized controlled trial.","BACKGROUND


Attaining the recommended level of adequacy of the infant's diet remains a serious challenge in most developing countries. Complementary foods, particularly in developing countries, are inadequate in quality and quantity that can result in adverse health and nutrition consequences in infants. This could be not only because of lack of food but also associated with caregiver's poor knowledge, harmful cultural norms and behaviors on infant feeding. The promotion of optimal complementary feeding through behavior change interventions is a global health priority. However, many of the interventions targeted only mothers/caregivers of infants, and studies that engaged other family members are limited worldwide. Moreover, such interventions are scarce in developing countries, including Ethiopia. This trial aimed to evaluate the effectiveness of complementary feeding behavior change communication delivered through community-level actors on the dietary adequacy of infants.
METHODS


We conducted a cluster-randomized controlled trial in rural communities of West Gojjam Zone, Northwest Ethiopia. Trial participants in the intervention clusters received complementary feeding behavior change communication for 9 months whereas those in the control clusters received only the usual care. Trained women development army leaders delivered the intervention. A pre-tested, structured interviewer-administered questionnaire was used for data collection. Generalized estimating equations regression analyses adjusted for baseline covariates and clustering were used to test the intervention effects.
RESULTS


The intervention showed positive statistically significant effects on the consumption of dairy products [RR = 1.8; 95% CI: 1.04-3.13], eggs [RR = 3; 95% CI: 1.35-6.56], vitamin A-rich fruits and vegetables [RR = 2.7; 95% CI: 1.17-6.1], other fruits and vegetables [RR = 5; 95% CI: 2.49-10.58] and animal-source foods [RR = 2; 95% CI: 1.39-2.87]. The proportions of infants who achieved minimum dietary diversity [RR = 3; 95% CI: 1.34, 7.39], minimum meal frequency [RR = 2.4; 95% CI: 1.37-4.29], and minimum acceptable diet [RR = 2.7; 95% CI: 1.13-7.23] were significantly higher in the intervention as compared to control groups.
CONCLUSIONS


Complementary feeding behavior change communication delivered through community-level actors significantly improved the dietary adequacy of infants.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03488680. Registered 5 April 2018- Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT03488680.",2020,"The intervention showed positive statistically significant effects on the consumption of dairy products [RR = 1.8; 95% CI: 1.04-3.13], eggs [RR = 3; 95% CI: 1.35-6.56], vitamin A-rich fruits and vegetables [RR = 2.7; 95% CI: 1.17-6.1], other fruits and vegetables [RR = 5; 95% CI: 2.49-10.58] and animal-source foods [RR = 2; 95% CI: 1.39-2.87].","['infants\xa0in rural communities of West Gojjam Zone, Northwest Ethiopia', 'rural communities of West Gojjam Zone, Northwest Ethiopia', 'Trained women development army leaders', 'infants']","['complementary feeding behavior change communication', 'complementary feeding behavior change communication delivered through community-level actors']","['consumption of dairy products', 'minimum meal frequency']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0086944', 'cui_str': 'Rural Communities'}, {'cui': 'C0037769', 'cui_str': 'West syndrome'}, {'cui': 'C0015024', 'cui_str': 'Ethiopia'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}]","[{'cui': 'C0038847', 'cui_str': 'Complementary Feeding'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0335083', 'cui_str': 'Actor'}]","[{'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0010947', 'cui_str': 'Dairy foods'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",,0.211057,"The intervention showed positive statistically significant effects on the consumption of dairy products [RR = 1.8; 95% CI: 1.04-3.13], eggs [RR = 3; 95% CI: 1.35-6.56], vitamin A-rich fruits and vegetables [RR = 2.7; 95% CI: 1.17-6.1], other fruits and vegetables [RR = 5; 95% CI: 2.49-10.58] and animal-source foods [RR = 2; 95% CI: 1.39-2.87].","[{'ForeName': 'Chalachew', 'Initials': 'C', 'LastName': 'Abiyu', 'Affiliation': 'School of Medicine, College of Medicine and Health Sciences, Wollo University, Dessie, Ethiopia.'}, {'ForeName': 'Tefera', 'Initials': 'T', 'LastName': 'Belachew', 'Affiliation': 'Faculty of Public Health, Department of Nutrition and Dietetics, Jimma University, Jimma, Ethiopia.'}]",PloS one,['10.1371/journal.pone.0238355']
2598,32889444,Evaluating substance use treatment efficacy for younger and older adults.,"The purpose of this study was to examine the differential efficacy of aftercare substance use treatments for younger (below 40, n = 107) versus older (40+, n = 114) adults (N = 221), using data from a randomized controlled trial in a community-based substance abuse treatment center. The younger adult sample had a mean age of 28.9 while the older adult sample had a mean age of 48.1. Primary outcomes were rates of abstinence and percent use days at 1-year follow-up. Outcomes were compared between standard cognitive behavioral relapse prevention (RP), Mindfulness-Based Relapse Prevention (MBRP), and 12-step-based treatment as usual (TAU). Results showed significant differences by treatment in the older, but not in younger, subsample of participants. Specifically, the older participants in MBRP had significantly higher abstinence rates compared with those in TAU. Further, the older individuals in MBRP had a significantly lower percent of days on which they used compared with those in TAU and RP. Overall, findings suggest that age group may impact aftercare treatment substance use outcomes.",2021,"Results showed significant differences by treatment in the older, but not in younger, subsample of participants.","['younger adult sample had a mean age of 28.9 while the older adult sample had a mean age of 48.1', 'younger (below 40, n\xa0=\xa0107) versus older (40+, n\xa0=\xa0114) adults (N\xa0=\xa0221), using data from a randomized controlled trial in a community-based substance abuse treatment center', 'younger and older adults']",['aftercare substance'],"['rates of abstinence and percent use days at 1-year follow-up', 'abstinence rates', 'standard cognitive behavioral relapse prevention (RP), Mindfulness-Based Relapse Prevention (MBRP), and 12-step-based treatment as usual (TAU']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0079256', 'cui_str': 'Substance abuse treatment center'}]","[{'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C0439861', 'cui_str': 'Substance'}]","[{'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0679867', 'cui_str': 'Relapse prevention'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",114.0,0.101879,"Results showed significant differences by treatment in the older, but not in younger, subsample of participants.","[{'ForeName': 'Tyree', 'Initials': 'T', 'LastName': 'Dingle', 'Affiliation': 'School of Graduate Psychology, Pacific University, United States. Electronic address: ding7624@pacificu.edu.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Bowen', 'Affiliation': 'School of Graduate Psychology, Pacific University, United States.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106618']
2599,32891018,Effects of multimodal balance training supported by rhythmical auditory stimuli in people with advanced stages of Parkinson's disease: a pilot randomized clinical trial.,"Non-pharmacological interventions such as physiotherapy are recognized as important elements in the overall clinical management of motor impairments in PD, but evidence of physiotherapy in advanced disease stages is sparse. A recent trial found positive effects of multimodal balance training in people with mild to moderate PD, with greater and more sustained effects when rhythmical auditory stimuli were added. It is unclear whether such multimodal balance training is also effective in people with advanced PD (Hoehn & Yahr stage 4).
METHODS


We performed a pilot prospective single-blind, randomized clinical trial to study the effectiveness of multimodal training with and without rhythmical auditory stimuli. We screened 76 people with Parkinson's disease and Hoehn & Yahr stage 4 by telephone; 35 patients were assigned randomly into two groups: (1) multimodal balance training with rhythmical auditory stimuli (RAS-supported intervention, n = 17) and (2) multimodal balance training without rhythmical auditory cues (n = 18). Training was performed for 5 weeks, two times/week. Primary outcome was the Mini-BESTest (MBEST) score immediately after the training period. Assessments were performed by the same two blinded assessors at baseline, immediately post intervention, and after one and 6-months follow-up.
RESULTS


Immediately post-intervention, both intervention groups improved significantly on Mini-Best scores, without differences between both intervention modalities. In both groups, results were retained at one-month follow-up. At 6-months follow-up, the effects were retained only in the RAS-supported intervention group. For both intervention groups, no improvements were found on secondary outcome measures for gait.
CONCLUSION


Both RAS-supported multimodal balance training and regular multimodal balance training improve balance in PD patients in advanced disease stages. Effects appear to sustain longer in the RAS-supported training group.",2020,"For both intervention groups, no improvements were found on secondary outcome measures for gait.
","['PD patients in advanced disease stages', ""people with advanced stages of Parkinson's disease"", 'people with advanced PD (Hoehn & Yahr stage 4', 'people with mild to moderate PD', ""76 people with Parkinson's disease and Hoehn & Yahr stage 4 by telephone; 35 patients""]","['multimodal balance training with rhythmical auditory stimuli (RAS-supported intervention, n\xa0=\xa017) and (2) multimodal balance training without rhythmical auditory cues', 'multimodal balance training and regular multimodal balance training', 'multimodal balance training', 'multimodal training with and without rhythmical auditory stimuli']","['Mini-BESTest (MBEST) score', 'gait', 'Mini-Best scores', 'rhythmical auditory stimuli']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0441772', 'cui_str': 'Stage level 4'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}]","[{'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0178490', 'cui_str': 'Auditory stimulus'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0205272', 'cui_str': 'Regular'}]","[{'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0178490', 'cui_str': 'Auditory stimulus'}]",76.0,0.0570846,"For both intervention groups, no improvements were found on secondary outcome measures for gait.
","[{'ForeName': 'Tamine T C', 'Initials': 'TTC', 'LastName': 'Capato', 'Affiliation': 'Radboud University Medical Centre, Donders Institute for Brain, Cognition and Behaviour, Department of Neurology, Centre of Expertise for Parkinson & Movement Disorders, Nijmegen, the Netherlands; University of São Paulo, Department of Neurology, Movement Disorders Center, São Paulo, Brazil. Electronic address: tamine.capato@radboudumc.nl.'}, {'ForeName': 'Jorik', 'Initials': 'J', 'LastName': 'Nonnekes', 'Affiliation': 'Radboud University Medical Centre, Donders Institute for Brain, Cognition and Behaviour; Department of Rehabilitation, Centre of Expertise for Parkinson & Movement Disorders, Nijmegen, the Netherlands; Sint Maartenskliniek, Department of Rehabilitation, Nijmegen, the Netherlands.'}, {'ForeName': 'Nienke M', 'Initials': 'NM', 'LastName': 'de Vries', 'Affiliation': 'Radboud University Medical Centre, Donders Institute for Brain, Cognition and Behaviour, Department of Neurology, Centre of Expertise for Parkinson & Movement Disorders, Nijmegen, the Netherlands.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'IntHout', 'Affiliation': 'Radboud University Medical Center, Department for Health Evidence, Radboud Institute for Health Sciences, Nijmegen, the Netherlands.'}, {'ForeName': 'Egberto R', 'Initials': 'ER', 'LastName': 'Barbosa', 'Affiliation': 'University of São Paulo, Department of Neurology, Movement Disorders Center, São Paulo, Brazil.'}, {'ForeName': 'Bastiaan R', 'Initials': 'BR', 'LastName': 'Bloem', 'Affiliation': 'Radboud University Medical Centre, Donders Institute for Brain, Cognition and Behaviour, Department of Neurology, Centre of Expertise for Parkinson & Movement Disorders, Nijmegen, the Netherlands.'}]",Journal of the neurological sciences,['10.1016/j.jns.2020.117086']
2600,32867156,Nonexercise Activity Thermogenesis-Induced Energy Shortage Improves Postprandial Lipemia and Fat Oxidation.,"(1) Background: This study investigated the effect of nonexercise activity thermogenesis on postprandial triglyceride (TG) concentrations; (2) Methods: Ten healthy males completed a sedentary trial (ST) and a physical activity trial (PA) in a random order separated by at least 7 days. After each intervention on day 1, the participants consumed a high-fat test meal on the next day. The blood samples and gas sample were observed in the fasted state and for 4 h after consuming the oral fat tolerance test; (3) Results: The postprandial TG concentrations of total (AUC) ( p  = 0.008) and incremental area under the curve (IAUC) ( p  = 0.023) in the plasma of participants in the PA trial were significantly lower than those in the plasma of participants in the ST trial. The postprandial fat oxidation rate AUC of the PA trial was significantly higher than that of the ST trial ( p  = 0.009); (4) Conclusions: The results of this study indicated that nonexercise energy expenditure decrease the postprandial TG concentration and increase the fat oxidation the next day.",2020,The postprandial TG concentrations of total (AUC) ( p  = 0.008) and incremental area under the curve (IAUC) ( p  = 0.023) in the plasma of participants in the PA trial were significantly lower than those in the plasma of participants in the ST trial.,['Ten healthy males completed a sedentary trial (ST) and a physical activity trial (PA) in a random order separated by at least 7 days'],['nonexercise activity thermogenesis'],"['postprandial TG concentration', 'incremental area under the curve (IAUC', 'postprandial fat oxidation rate AUC', 'postprandial triglyceride (TG) concentrations', 'Postprandial Lipemia and Fat Oxidation', 'postprandial TG concentrations of total (AUC', 'blood samples and gas sample']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0018841', 'cui_str': 'Heat Production'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0020473', 'cui_str': 'Hyperlipidemia'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]",10.0,0.0290961,The postprandial TG concentrations of total (AUC) ( p  = 0.008) and incremental area under the curve (IAUC) ( p  = 0.023) in the plasma of participants in the PA trial were significantly lower than those in the plasma of participants in the ST trial.,"[{'ForeName': 'Chih-Hui', 'Initials': 'CH', 'LastName': 'Chiu', 'Affiliation': 'Graduate Program in Department of Exercise Health Science, National Taiwan University of Sport, Taichung 404, Taiwan.'}, {'ForeName': 'Che-Hsiu', 'Initials': 'CH', 'LastName': 'Chen', 'Affiliation': 'Department of Sports Performance, National Taiwan University of Sport, Taichung 404, Taiwan.'}, {'ForeName': 'Min-Huan', 'Initials': 'MH', 'LastName': 'Wu', 'Affiliation': 'Sport Recreation and Health Management Degree Program, Tunghai University, Taichung 404, Taiwan.'}, {'ForeName': 'Yin-Fu', 'Initials': 'YF', 'LastName': 'Ding', 'Affiliation': 'Graduate Program in Department of Exercise Health Science, National Taiwan University of Sport, Taichung 404, Taiwan.'}]","Life (Basel, Switzerland)",['10.3390/life10090166']
2601,32872401,"Influence of Short-Term Hyperenergetic, High-Fat Feeding on Appetite, Appetite-Related Hormones, and Food Reward in Healthy Men.","Short-term overfeeding may provoke compensatory appetite responses to correct the energy surplus. However, the initial time-course of appetite, appetite-related hormone, and reward-related responses to hyperenergetic, high-fat diets (HE-HFD) are poorly characterised. Twelve young healthy men consumed a HE-HFD (+50% energy, 65% fat) or control diet (36% fat) for seven days in a randomised crossover design. Mean appetite perceptions were determined during an oral glucose tolerance test (OGTT) before and after each diet. Fasted appetite perceptions, appetite-related hormones, and reward parameters were measured pre-diet and after 1-, 3- and 7-days of each diet. The HE-HFD induced a pre-to-post diet suppression in mean appetite during the OGTT (all ratings  p  ≤ 0.058, effect size ( d ) ≥ 0.31), and reduced the preference for high-fat vs. low-fat foods (main effect diet  p  = 0.036,  d  = 0.32). Fasted leptin was higher in the HE-HFD than control diet (main effect diet  p  < 0.001,  d  = 0.30), whilst a diet-by-time interaction ( p  = 0.036) revealed fasted acylated ghrelin was reduced after 1-, 3- and 7-days of the HE-HFD (all  p  ≤ 0.040,  d  ≥ 0.50 vs. pre-diet). Appetite perceptions and total peptide YY in the fasted state exhibited similar temporal patterns between the diets (diet-by-time interaction  p  ≥ 0.077). Seven days of high-fat overfeeding provokes modest compensatory changes in subjective, hormonal, and reward-related appetite parameters.",2020,"Seven days of high-fat overfeeding provokes modest compensatory changes in subjective, hormonal, and reward-related appetite parameters.","['Healthy Men', 'Twelve young healthy men']","['control diet ', 'Short-Term Hyperenergetic, High-Fat Feeding', 'control diet', 'HE-HFD']","['Appetite perceptions and total peptide YY', 'subjective, hormonal, and reward-related appetite parameters', 'Fasted leptin', 'Mean appetite perceptions', 'mean appetite', 'Fasted appetite perceptions, appetite-related hormones, and reward parameters']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C0743195', 'cui_str': 'Dietary control'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0521974', 'cui_str': 'High fat diet'}]","[{'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0070358', 'cui_str': 'Peptide YY'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}]",12.0,0.0163331,"Seven days of high-fat overfeeding provokes modest compensatory changes in subjective, hormonal, and reward-related appetite parameters.","[{'ForeName': 'Alice E', 'Initials': 'AE', 'LastName': 'Thackray', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough LE1 3TU, UK.'}, {'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'Willis', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough LE1 3TU, UK.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Clayton', 'Affiliation': 'School of Science and Technology, Nottingham Trent University, Nottingham NG1 8NS, UK.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Broom', 'Affiliation': 'Centre for Sport, Exercise and Life Sciences, Coventry University, Coventry CV1 2DS, UK.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Finlayson', 'Affiliation': 'School of Psychology, Faculty of Medicine and Health, University of Leeds, Leeds LS2 9JT, UK.'}, {'ForeName': 'Fernanda R', 'Initials': 'FR', 'LastName': 'Goltz', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough LE1 3TU, UK.'}, {'ForeName': 'Jack A', 'Initials': 'JA', 'LastName': 'Sargeant', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester LE5 4PW, UK.'}, {'ForeName': 'Rachel M', 'Initials': 'RM', 'LastName': 'Woods', 'Affiliation': 'Medical School, University of Lincoln, Lincoln LN6 7TS, UK.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Stensel', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough LE1 3TU, UK.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'King', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough LE1 3TU, UK.'}]",Nutrients,['10.3390/nu12092635']
2602,32872411,Supplemental Nutrition Assistance Program-Education Improves Food Security Independent of Food Assistance and Program Characteristics.,"The purpose of this project was to determine whether consistent food assistance program participation or changes in participation over time mediated or moderated the effect of federal nutrition education through the Supplemental Nutrition Assistance Program-Education (SNAP-Ed) on food security and determine the associations of SNAP-Ed program delivery characteristics with change in food security. This secondary analysis used data from a randomized controlled trial from September 2013 through April 2015. SNAP-Ed-eligible participants ( n  = 328; ≥18 years) in households with children were recruited from 39 counties in Indiana, USA. The dependent variable was one year change in household food security score measured using the United States Household Food Security Survey Module. Assessment of mediation used Barron-Kenny analysis and moderation used interactions of food assistance program use and changes over time with treatment group in general linear regression modeling. Program delivery characteristics were investigated using mixed linear regression modeling. Results showed that neither consistent participation nor changes in food assistance program participation over time mediated nor moderated the effect of SNAP-Ed on food security and neither were SNAP-Ed program delivery characteristics associated with change in food security over the one year study period. SNAP-Ed directly improved food security among SNAP-Ed-eligible Indiana households with children regardless of food assistance program participation and changes over time or varying program delivery characteristics.",2020,Results showed that neither consistent participation nor changes in food assistance program participation over time mediated nor moderated the effect of SNAP-Ed on food security and neither were SNAP-Ed program delivery characteristics associated with change in food security over the one year study period.,"['SNAP-Ed-eligible participants ( n  = 328; ≥18 years) in households with children were recruited from 39 counties in Indiana, USA', 'September 2013 through April 2015']",[],"['food security', 'household food security score']","[{'cui': 'C3494397', 'cui_str': 'SNAP Program'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0021206', 'cui_str': 'Indiana'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]",[],"[{'cui': 'C3178753', 'cui_str': 'Food Security'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0457407,Results showed that neither consistent participation nor changes in food assistance program participation over time mediated nor moderated the effect of SNAP-Ed on food security and neither were SNAP-Ed program delivery characteristics associated with change in food security over the one year study period.,"[{'ForeName': 'Heather A', 'Initials': 'HA', 'LastName': 'Eicher-Miller', 'Affiliation': 'Department of Nutrition Science, Purdue University, West Lafayette, IN 47907, USA.'}, {'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Rivera', 'Affiliation': 'Department of Nutrition Science, Purdue University, West Lafayette, IN 47907, USA.'}, {'ForeName': 'Hanxi', 'Initials': 'H', 'LastName': 'Sun', 'Affiliation': 'Department of Statistics, Purdue University, West Lafayette, IN 47907, USA.'}, {'ForeName': 'Yumin', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Statistics, Purdue University, West Lafayette, IN 47907, USA.'}, {'ForeName': 'Melissa K', 'Initials': 'MK', 'LastName': 'Maulding', 'Affiliation': 'Health and Human Sciences Cooperative Extension, Purdue University, West Lafayette, IN 47907, USA.'}, {'ForeName': 'Angela R', 'Initials': 'AR', 'LastName': 'Abbott', 'Affiliation': 'Health and Human Sciences Cooperative Extension, Purdue University, West Lafayette, IN 47907, USA.'}]",Nutrients,['10.3390/nu12092636']
2603,32872431,Emotional Education in Early Onset Schizophrenia and Asperger's Syndrome.,"In this study, we aim to verify how emotional training can improve empathy and theory of mind (ToM) in patients diagnosed with early onset schizophrenia and Asperger's syndrome. The study design includes 100 subjects divided into two experimental groups and two control groups. The two experimental groups followed a rational emotive behavior therapy (REBT) protocol. The two control groups instead underwent cognitive behavioral psychotherapy training. Analysis of Variance (ANOVA) was applied to analyze the difference between the Asperger's syndrome (AS) and early onset schizophrenia (EOS) groups, pre and post training. Our analysis shows that the AS group improved post emotional training but only when emotions were internalized, as demonstrated by the improvement of the scores in the post-treatment eye test (ET) but not in the emotional quotient (EQ) test. The EOS group instead showed post-training improvement, not only concerning skills leading to internalizing emotions but also in empathy, as demonstrated by the improvement of EQ and Reflective Functioning Questionnaire (RFQ) test scores. These scores remained lower than in the control group. Finally, our findings reveal that the value of the treatment was more considerable for the EOS group than for the AS group due to the improvement in first- and second-order ToM skills and an improvement of empathic skills in the first group, followed by the group comprising AS subjects. In the AS group, the treatment only favored the enhancement of first-order ToM skills; however, this improved quality of life and social adaptation.",2020,"The EOS group instead showed post-training improvement, not only concerning skills leading to internalizing emotions but also in empathy, as demonstrated by the improvement of EQ and Reflective Functioning Questionnaire (RFQ) test scores.","['100 subjects divided into two experimental groups and two control groups', ""patients diagnosed with early onset schizophrenia and Asperger's syndrome"", ""Early Onset Schizophrenia and Asperger's Syndrome""]","['emotional training', 'cognitive behavioral psychotherapy training', 'rational emotive behavior therapy (REBT) protocol']","['internalizing emotions', 'EQ and Reflective Functioning Questionnaire (RFQ) test scores', 'empathy and theory of mind (ToM', 'post emotional training', 'Emotional Education', 'quality of life and social adaptation', 'empathic skills']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1656427', 'cui_str': 'Early onset schizophrenia'}, {'cui': 'C0236792', 'cui_str': ""Asperger's disorder""}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0935573', 'cui_str': 'Theory of Mind'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}]",100.0,0.0114394,"The EOS group instead showed post-training improvement, not only concerning skills leading to internalizing emotions but also in empathy, as demonstrated by the improvement of EQ and Reflective Functioning Questionnaire (RFQ) test scores.","[{'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Frolli', 'Affiliation': 'DRC-Disability Research Centre, University of International Studies of Rome, 00147 Rome, Italy.'}, {'ForeName': 'Maria Carla', 'Initials': 'MC', 'LastName': 'Ricci', 'Affiliation': 'FINDS-Italian Neuroscience and Developmental Disorders Foundation, 81040 Caserta, Italy.'}, {'ForeName': 'Francesco Alberto', 'Initials': 'FA', 'LastName': 'Tortorelli', 'Affiliation': 'SPEE-Specialization School in Cognitive Behavioral Psychotherapy for Developmental Age Disorders, 80142 Naples, Italy.'}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Cavallaro', 'Affiliation': 'SPEE-Specialization School in Cognitive Behavioral Psychotherapy for Developmental Age Disorders, 80142 Naples, Italy.'}, {'ForeName': 'Luana', 'Initials': 'L', 'LastName': 'Valenzano', 'Affiliation': 'FINDS-Italian Neuroscience and Developmental Disorders Foundation, 81040 Caserta, Italy.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Rega', 'Affiliation': 'Department of Psychology, University of Naples, 80100 Naples, Italy.'}, {'ForeName': 'Francesca Felicia', 'Initials': 'FF', 'LastName': 'Operto', 'Affiliation': 'Department of Child Neuropsychiatry, University of Salerno, 84080 Fisciano, Italy.'}, {'ForeName': 'Giulio', 'Initials': 'G', 'LastName': 'Corrivetti', 'Affiliation': 'ASL (SA), Department of Mental Health, 84122 Salerno, Italy.'}]","Behavioral sciences (Basel, Switzerland)",['10.3390/bs10090131']
2604,32873590,"Mechanisms Underlying Absent Training-Induced Improvement in Insulin Action in Lean, Hyperandrogenic Women With Polycystic Ovary Syndrome.","Women with polycystic ovary syndrome (PCOS) have been shown to be less insulin sensitive compared with control (CON) women, independent of BMI. Training is associated with molecular adaptations in skeletal muscle, improving glucose uptake and metabolism in both healthy individuals and patients with type 2 diabetes. In the current study, lean hyperandrogenic women with PCOS ( n  = 9) and healthy CON women ( n  = 9) completed 14 weeks of controlled and supervised exercise training. In CON, the training intervention increased whole-body insulin action by 26% and insulin-stimulated leg glucose uptake by 53% together with increased insulin-stimulated leg blood flow and a more oxidative muscle fiber type distribution. In PCOS, no such changes were found, despite similar training intensity and improvements in VO 2max  In skeletal muscle of CON but not PCOS, training increased GLUT4 and HKII mRNA and protein expressions. These data suggest that the impaired increase in whole-body insulin action in women with PCOS with training is caused by an impaired ability to upregulate key glucose-handling proteins for insulin-stimulated glucose uptake in skeletal muscle and insulin-stimulated leg blood flow. Still, other important benefits of exercise training appeared in women with PCOS, including an improvement of the hyperandrogenic state.",2020,"In CON, the training intervention increased whole body insulin action by 26% and insulin-stimulated leg glucose uptake by 53%, together with increased insulin-stimulated leg blood flow and a more oxidative muscle fiber type distribution.","['lean, hyperandrogenic women with PCOS (n=9) and healthy controls (CON, n=9) completed 14 weeks of', 'Lean, Hyperandrogenic Women With Polycystic Ovary Syndrome (PCOS', 'Women with polycystic ovary syndrome (PCOS', 'women with PCOS with training', 'women with PCOS', 'healthy and type 2 diabetic individuals']","['controlled and supervised exercise training', 'exercise training']","['maximal oxygen uptake', 'whole body insulin action', 'GLUT4 and HKII mRNA and protein expressions']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}]",,0.0307935,"In CON, the training intervention increased whole body insulin action by 26% and insulin-stimulated leg glucose uptake by 53%, together with increased insulin-stimulated leg blood flow and a more oxidative muscle fiber type distribution.","[{'ForeName': 'Solvejg L', 'Initials': 'SL', 'LastName': 'Hansen', 'Affiliation': 'Molecular Physiology Section, Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Kirstine N', 'Initials': 'KN', 'LastName': 'Bojsen-Møller', 'Affiliation': 'Department of Endocrinology, Copenhagen University Hospital Hvidovre, Hvidovre, Denmark.'}, {'ForeName': 'Anne-Marie', 'Initials': 'AM', 'LastName': 'Lundsgaard', 'Affiliation': 'Molecular Physiology Section, Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Frederikke L', 'Initials': 'FL', 'LastName': 'Hendrich', 'Affiliation': 'Molecular Physiology Section, Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Lisbeth', 'Initials': 'L', 'LastName': 'Nilas', 'Affiliation': 'Department of Obstetrics and Gynaecology, Copenhagen University Hospital Hvidovre, Hvidovre, Denmark.'}, {'ForeName': 'Kim A', 'Initials': 'KA', 'LastName': 'Sjøberg', 'Affiliation': 'Molecular Physiology Section, Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Janne R', 'Initials': 'JR', 'LastName': 'Hingst', 'Affiliation': 'Molecular Physiology Section, Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Annette K', 'Initials': 'AK', 'LastName': 'Serup', 'Affiliation': 'Molecular Physiology Section, Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Carlos Henríquez', 'Initials': 'CH', 'LastName': 'Olguín', 'Affiliation': 'Molecular Physiology Section, Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Christian S', 'Initials': 'CS', 'LastName': 'Carl', 'Affiliation': 'Molecular Physiology Section, Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Louise F', 'Initials': 'LF', 'LastName': 'Wernblad', 'Affiliation': 'Molecular Physiology Section, Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Henneberg', 'Affiliation': 'Molecular Physiology Section, Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Katja M', 'Initials': 'KM', 'LastName': 'Lustrup', 'Affiliation': 'Molecular Physiology Section, Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Hansen', 'Affiliation': 'Molecular Physiology Section, Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Jensen', 'Affiliation': 'Molecular Physiology Section, Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Sten', 'Initials': 'S', 'LastName': 'Madsbad', 'Affiliation': 'Department of Endocrinology, Copenhagen University Hospital Hvidovre, Hvidovre, Denmark.'}, {'ForeName': 'Jørgen F P', 'Initials': 'JFP', 'LastName': 'Wojtaszewski', 'Affiliation': 'Molecular Physiology Section, Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Erik A', 'Initials': 'EA', 'LastName': 'Richter', 'Affiliation': 'Molecular Physiology Section, Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Bente', 'Initials': 'B', 'LastName': 'Kiens', 'Affiliation': 'Molecular Physiology Section, Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Copenhagen, Denmark bkiens@nexs.ku.dk.'}]",Diabetes,['10.2337/db20-0062']
2605,32873957,Effects of dietary protein-load and alkaline supplementation on acid-base balance and glucose metabolism in healthy elderly.,"BACKGROUND/OBJECTIVES


Metabolism is controlled by macro- and micronutrients. Protein-rich diets should lead to latent acidosis at tissue level with further negative implications. Food supplements with alkaline salts are available and popular pretending to prevent these changes.
SUBJECTS/METHODS


Within a randomised double-blind placebo-controlled trial we tested the hypotheses that (1) a 4-week protein-rich diet induces a latent tissue acidosis and (2) an alkaline supplement can compensate this. Acid-base balance and important metabolic parameters were determined before and after 4 weeks of supplementation by peripheral blood samples, indirect calorimetry and muscle microdialysis before and after a protein-rich test meal.
RESULTS


Fourty volunteers were randomised 1:1 to either verum or placebo supplements. Protein-rich diet by itself did not significantly affect acid-base balance. Alkaline supplementation increased plasma bicarbonate concentration without changing pH. Postprandial increases in serum glucose and insulin tended to be lower for verum vs. placebo. Resting and postprandial energy metabolism, and carbohydrate and fat oxidation did not differ significantly before and after supplementation in both groups. In muscle, postprandial glucose uptake and aerobic glucose oxidation were significantly higher for verum. In addition, verum significantly increased serum magnesium concentrations.
CONCLUSIONS


Four weeks of protein-rich diet did not significantly influence acid-base balance. However, alkaline supplementation improved systemic and tissue acid-base parameters and oxidative glucose metabolism.",2020,Alkaline supplementation increased plasma bicarbonate concentration without changing pH. Postprandial increases in serum glucose and insulin tended to be lower for verum vs. placebo.,"['healthy elderly', 'Fourty volunteers']","['dietary protein-load and alkaline supplementation', 'Alkaline supplementation', 'Protein-rich diets', 'placebo', 'alkaline supplementation', 'Food supplements with alkaline salts', 'verum or placebo']","['Resting and postprandial energy metabolism, and carbohydrate and fat oxidation', 'serum glucose and insulin', 'systemic and tissue acid-base parameters and oxidative glucose metabolism', 'serum magnesium concentrations', 'plasma bicarbonate concentration', 'acid-base balance and glucose metabolism', 'postprandial glucose uptake and aerobic glucose oxidation']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0012177', 'cui_str': 'Proteins, Dietary'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0036140', 'cui_str': 'Salts'}]","[{'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0202041', 'cui_str': 'Glucose measurement, serum'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0202125', 'cui_str': 'Magnesium measurement, serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0858075', 'cui_str': 'Plasma bicarbonate'}, {'cui': 'C0001117', 'cui_str': 'Acid-base equilibrium'}]",,0.11489,Alkaline supplementation increased plasma bicarbonate concentration without changing pH. Postprandial increases in serum glucose and insulin tended to be lower for verum vs. placebo.,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Boschmann', 'Affiliation': 'Experimental and Clinical Research Center (ECRC) - a joint co-operation between Charité - Universitätsmedizin Berlin and Max Delbrueck Center for Molecular Medicine, Berlin, Germany.'}, {'ForeName': 'Nikoletta', 'Initials': 'N', 'LastName': 'Kaiser', 'Affiliation': 'Experimental and Clinical Research Center (ECRC) - a joint co-operation between Charité - Universitätsmedizin Berlin and Max Delbrueck Center for Molecular Medicine, Berlin, Germany.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Klasen', 'Affiliation': 'Experimental and Clinical Research Center (ECRC) - a joint co-operation between Charité - Universitätsmedizin Berlin and Max Delbrueck Center for Molecular Medicine, Berlin, Germany.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Klug', 'Affiliation': 'Experimental and Clinical Research Center (ECRC) - a joint co-operation between Charité - Universitätsmedizin Berlin and Max Delbrueck Center for Molecular Medicine, Berlin, Germany.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Mähler', 'Affiliation': 'Experimental and Clinical Research Center (ECRC) - a joint co-operation between Charité - Universitätsmedizin Berlin and Max Delbrueck Center for Molecular Medicine, Berlin, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Michalsen', 'Affiliation': 'Department for Internal and Integrative Medicine, Charité - Universitätsmedizin Berlin and Immanuel Krankenhaus, Berlin, Germany.'}, {'ForeName': 'Juergen', 'Initials': 'J', 'LastName': 'Vormann', 'Affiliation': 'Institut für Prävention und Ernährung, Ismaning, Germany.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Werner', 'Affiliation': 'NuOmix Research k.s. Applied Nutriomic Research, Martin, Slovakia.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Stange', 'Affiliation': 'DZHK (German Centre for Cardiovascular Research), Berlin, Germany. r.stange@immanuel.de.'}]",European journal of clinical nutrition,['10.1038/s41430-020-0695-3']
2606,32876010,"Primary Prophylaxis to Prevent Tuberculosis Infection in Prison Inmates: A Randomized, Double-Blind, Placebo-Controlled Trial.","In many low- and middle-income countries, tuberculosis (TB) incidence in prisons is high, exposing incarcerated populations to an elevated risk of TB infection. We conducted a randomized, double-blind, placebo-controlled trial among HIV-negative male inmates of a high TB burden prison to determine whether isoniazid given twice weekly (900 mg) for 12 months prevents TB infection. The primary outcome was QuantiFERON-TB Gold in Plus (QFT) conversion to ≥ 0.35 international units per milliliter (IU/mL) at 6 months; secondary outcomes included alternative QFT thresholds (≥ 0.7, ≥ 2.0, and ≥ 4.0 IU/mL). In total, 467 participants were randomly assigned to intervention ( N  = 258) or control ( N  = 209). In an interim analysis of participants who had completed 6 months of follow-up ( N  = 170), QFT conversion occurred in 20.8% (19/91) and 21.5% (17/79) of participants in intervention and control arms (efficacy: 2.9%,  P  = 0.91), respectively. The trial was then stopped according to the trial protocol, and the remaining participants prematurely discontinued. In an analysis of secondary outcomes, the intervention arm had significantly lower rates of conversion at a cutoff of ≥ 2.0 IU/mL (efficacy: 82.6%,  P  < 0.01). In conclusion, 900 mg of isoniazid, administered twice a week, did not effectively prevent QFT conversion at a cutoff point ≥ 0.35 IU/mL in a trial of QFT-negative inmates. Higher QFT cutoffs are associated with sustained conversion and greater protection. Future clinical trials that evaluate protection for latent infection should use the highest cutoff than that recommended by the manufacturer.",2020,"In an analysis of secondary outcomes, the intervention arm had significantly lower rates of conversion at a cutoff of ≥ 2.0 IU/mL (efficacy: 82.6%,  P  < 0.01).","['Prison Inmates', '467 participants were randomly assigned to intervention ( N  = 258) or control ( N  = 209', 'HIV-negative male inmates of a high TB burden prison']","['placebo', 'Placebo', 'isoniazid']","['QFT conversion', 'QuantiFERON-TB Gold in Plus (QFT) conversion to ≥ 0.35 international units per milliliter (IU/mL', 'alternative QFT thresholds', 'TB infection', 'rates of conversion']","[{'cui': 'C0033167', 'cui_str': 'Prisoners'}, {'cui': 'C4517784', 'cui_str': '467'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0481430', 'cui_str': 'HIV negative'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033168', 'cui_str': 'Prisons'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0022209', 'cui_str': 'isoniazid'}]","[{'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4517451', 'cui_str': '0.35'}, {'cui': 'C0439458', 'cui_str': 'IU/mL'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]",467.0,0.713576,"In an analysis of secondary outcomes, the intervention arm had significantly lower rates of conversion at a cutoff of ≥ 2.0 IU/mL (efficacy: 82.6%,  P  < 0.01).","[{'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Dias de Oliveira', 'Affiliation': 'Federal University of Mato Grosso do Sul, Campo Grande, Brazil.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'da Silva Santos', 'Affiliation': 'Federal University of Grande Dourados, Dourados, Brazil.'}, {'ForeName': 'Cassia Barbosa', 'Initials': 'CB', 'LastName': 'Reis', 'Affiliation': 'Federal University of Mato Grosso do Sul, Campo Grande, Brazil.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'de Cássia Leite', 'Affiliation': 'Federal University of Mato Grosso do Sul, Campo Grande, Brazil.'}, {'ForeName': 'Flávia Patussi', 'Initials': 'FP', 'LastName': 'Correia Sacchi', 'Affiliation': 'Municipal Health Office, Dourados, Brazil.'}, {'ForeName': 'Rafaele Carla Pivetta', 'Initials': 'RCP', 'LastName': 'de Araujo', 'Affiliation': 'Federal University of Grande Dourados, Dourados, Brazil.'}, {'ForeName': 'Paulo César Pereira', 'Initials': 'PCP', 'LastName': 'Dos Santos', 'Affiliation': 'Federal University of Grande Dourados, Dourados, Brazil.'}, {'ForeName': 'Valeria Cavalcanti', 'Initials': 'VC', 'LastName': 'Rolla', 'Affiliation': 'Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Martinez', 'Affiliation': 'Stanford University, Stanford, California.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Andrews', 'Affiliation': 'Stanford University, Stanford, California.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Croda', 'Affiliation': 'Federal University of Mato Grosso do Sul, Campo Grande, Brazil.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.20-0110']
2607,32877557,Rapid Versus Laboratory-Based Testing for HIV and Hepatitis C at a Drug Detoxification Treatment Center: A Randomized Trial.,"BACKGROUND


A health department survey revealed nearly half employ laboratory-based HIV and HCV testing (LBT) over rapid testing (RT) in nonhospital settings such as drug detoxification centers. LBT has higher sensitivity for acute HIV infection compared to RT but LBT is not point of care and may result in fewer diagnoses due to loss to follow-up before result delivery.
METHODS


We conducted a randomized trial comparing real-world case notification of RT (Orasure) vs LBT (HIV Combo Ag/Ab EIA, HCV EIA) for HIV and HCV at a drug detoxification center. Primary outcome was receipt of test results within 2 weeks.
RESULTS


Among 341 individuals screened (11/2016-7/2017), 200 met inclusion criteria; 58% injected drugs and 31% shared needles in the previous 6 months. Of the 200 randomized, 98 received RT and 102 LBT. Among all participants, 0.5% were positive for HIV and 48% for HCV; 96% received test results in the RT arm and 42% in the LBT arm (odds ratio, 28.72; 95% confidence interval, 10.27-80.31). Real-world case notification was 95% and 93% for HIV and HCV RT, respectively, compared to 42% for HIV and HCV LBT.
CONCLUSIONS


RT has higher real-world case notification than LBT at drug detoxification centers.Clinical trials registration: NCT02869776.",2020,"Among all participants, 0.5% were positive for HIV and 48% for HCV; 96% received test results in the RT arm and 42% in the LBT arm (odds ratio, 28.72; 95% confidence interval, 10.27-80.31).","['341 individuals screened (11/2016-7/2017), 200 met inclusion criteria; 58% injected drugs and 31% shared needles in the previous 6 months']","['LBT', 'Rapid Versus Laboratory-Based Testing for HIV and Hepatitis C', 'HCV testing (LBT) over rapid testing (RT', 'RT (Orasure) vs LBT (HIV Combo Ag/Ab EIA, HCV EIA']","['Real-world case notification', 'receipt of test results within 2 weeks']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0019196', 'cui_str': 'Viral hepatitis C'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0014661', 'cui_str': 'Swamp Fever'}]","[{'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0422202', 'cui_str': 'Notifications'}, {'cui': 'C0456984', 'cui_str': 'Test finding'}, {'cui': 'C0439230', 'cui_str': 'week'}]",,0.431165,"Among all participants, 0.5% were positive for HIV and 48% for HCV; 96% received test results in the RT arm and 42% in the LBT arm (odds ratio, 28.72; 95% confidence interval, 10.27-80.31).","[{'ForeName': 'Sabrina A', 'Initials': 'SA', 'LastName': 'Assoumou', 'Affiliation': 'Section of Infectious Diseases, Department of Medicine, Boston University School of Medicine, Boston, Massachusetts, USA.'}, {'ForeName': 'Samantha M', 'Initials': 'SM', 'LastName': 'Paniagua', 'Affiliation': 'Section of Infectious Diseases, Department of Medicine, Boston Medical Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Benjamin P', 'Initials': 'BP', 'LastName': 'Linas', 'Affiliation': 'Section of Infectious Diseases, Department of Medicine, Boston University School of Medicine, Boston, Massachusetts, USA.'}, {'ForeName': 'Jianing', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Section of Infectious Diseases, Department of Medicine, Boston Medical Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Jeffrey H', 'Initials': 'JH', 'LastName': 'Samet', 'Affiliation': 'Boston University School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Hall', 'Affiliation': 'Section of Infectious Diseases, Department of Medicine, Boston Medical Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Laura F', 'Initials': 'LF', 'LastName': 'White', 'Affiliation': 'Department of Biostatistics, Boston University School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Curt G', 'Initials': 'CG', 'LastName': 'Beckwith', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Alpert Medical School of Brown University, Providence, Rhode Island, USA.'}]",The Journal of infectious diseases,['10.1093/infdis/jiaa162']
2608,32878594,Short-term aerobic training improves heart rate variability in men living with HIV: a pre-post pilot study.,"BACKGROUND


Heart rate variability (HRV) a feasible predictor of prognosis in cardiovascular outcomes shown to be reduced in people living with HIV (PLWH).
OBJECTIVE


This study sought to understand the effects of short-term aerobic training (AT) on the resting HRV and endothelial function in this population.
METHODS


PLWH performed 24 sessions of AT protocol. The protocol consists of 40 min of treadmill (60 to 80% of the VO 2max ), 3 times per week, for 8 weeks. HRV (standard deviation of all normal RR intervals - SDNN; root mean square of the successive differences - rMSSD; low frequency - LF; high frequency - HF; LF:HF ratio) and endothelial function parameters were evaluated by EndoPAT system pre and post intervention.
RESULTS


7 men, the median age of the sample was 49 years (range, 38-68 years), completed the protocol. AT improved resting HRV parameters: SDNN (p = 0.02, power analysis (PA) 0.54), rMSSD (p = 0.02, PA = 0.99), LF (p = 0.02, PA = 0.85). HF, LF:HF ratio and endothelial function parameters showed no changes.
CONCLUSIONS


The results suggest the short-term AT may improve HRV in men living with HIV.",2020,"SDNN (p = 0.02, power analysis (PA) 0.54), rMSSD (p = 0.02, PA = 0.99), LF (p = 0.02, PA = 0.85).","['7 men, the median age of the sample was 49\u2009years (range, 38-68\u2009years', 'people living with HIV (PLWH', 'men living with HIV']","['Short-term aerobic training', 'short-term aerobic training (AT', 'HF, LF']","['resting HRV parameters', 'HRV', 'rMSSD', 'HF ratio and endothelial function parameters', 'heart rate variability']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0647859', 'cui_str': 'AM 49'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C1821417', 'cui_str': 'Resting heart rate'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",,0.0907765,"SDNN (p = 0.02, power analysis (PA) 0.54), rMSSD (p = 0.02, PA = 0.99), LF (p = 0.02, PA = 0.85).","[{'ForeName': 'Candissa Silva', 'Initials': 'CS', 'LastName': 'da Silva', 'Affiliation': 'Post-Graduation Program in Health Sciences, Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, Brazil.'}, {'ForeName': 'Luís Fernando', 'Initials': 'LF', 'LastName': 'Deresz', 'Affiliation': 'Physical Education Department, Universidade Federal de Juiz de Fora, Campus Governador Valadares, Governador Valadares, Brazil.'}, {'ForeName': 'Giovana de Marchi', 'Initials': 'GM', 'LastName': 'Castelli', 'Affiliation': 'Physiotherapy Course Department, UFCSPA, Porto Alegre, Brazil.'}, {'ForeName': 'Gilson Pires', 'Initials': 'GP', 'LastName': 'Dorneles', 'Affiliation': 'Post-Graduation Program in Health Sciences, Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, Brazil.'}, {'ForeName': 'Letícia', 'Initials': 'L', 'LastName': 'Mignoni', 'Affiliation': 'Physiotherapy Course Department, UFCSPA, Porto Alegre, Brazil.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Dal Lago', 'Affiliation': 'Post-Graduation Program in Health Sciences, Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, Brazil.'}]",HIV research & clinical practice,['10.1080/25787489.2020.1810452']
2609,32881912,Feasibility of quantifying change in immune white cells in abdominal adipose tissue in response to an immune modulator in clinical obesity.,"BACKGROUND


Obesity is often associated with inflammation in adipose tissue (AT) with release of mediators of atherogenesis. We postulated that it would be feasible to collect sufficient abdominal AT to quantify changes in a broad array of adaptive and innate mononuclear white cells in obese non-diabetic adults in response to a dipeptidyl protease inhibitor (DPP4i), known to inhibit activation of immune white cells.
METHODS


Adults 18-55 years-of-age were screened for abdominal obesity and insulin resistance or impaired glucose tolerance but without known inflammatory conditions. Twenty-one eligible participants consented for study and were randomized 3:1 to receive sitagliptin (DPP4i) at 100mg or matching placebo daily for 28 days. Abdominal AT collected by percutaneous biopsy and peripheral blood mononuclear cell fractions were evaluated before and after treatment; plasma was stored for batch testing.
RESULTS


Highly sensitive C-reactive protein, a global marker of inflammation, was not elevated in the study population. Innate lymphoid cells (ILC) type 3 (ILC-3) in abdominal AT decreased with active treatment compared with placebo (p = 0.04). Other immune white cells in AT and peripheral blood mononuclear cell (PBMC) fractions did not change with treatment compared to placebo (p>0.05); although ILC-2 declined in PBMCs (p = 0.007) in the sitagliptin treatment group. Two circulating biomarkers of atherogenesis, interferon-inducible protein-10 (IP-10) and sCD40L declined in plasma (p = 0.02 and p = 0.07, respectively) in the active treatment group, providing indirect validation of a net reduction in inflammation.
CONCLUSIONS


In this pilot study, two cell types of the innate lymphoid system, ILC-3 in AT and ILC-2 PBMCs declined during treatment and as did circulating biomarkers of atherogenesis. Changes in other immune cells were not demonstrable. The study showed that sufficient abdominal AT could be obtained to quantify white cells of both innate and adaptive immunity and to demonstrate changes during therapy with an immune inhibitor.
TRIAL REGISTRATION


ClinicalTrials.gov identifier (NCT number): NCT02576.",2020,Other immune white cells in AT and peripheral blood mononuclear cell (PBMC) fractions did not change with treatment compared to placebo (p>0.05); although ILC-2 declined in PBMCs (p = 0.007) in the sitagliptin treatment group.,"['Twenty-one eligible participants consented for study', 'Adults 18-55 years-of-age were screened for abdominal obesity and insulin resistance or impaired glucose tolerance but without known inflammatory conditions', 'obese non-diabetic adults']","['placebo', 'sitagliptin (DPP4i) at 100mg or matching placebo']","['Innate lymphoid cells (ILC) type 3 (ILC-3', 'ILC-2 declined in PBMCs', 'ILC-3 in AT and ILC-2 PBMCs', 'peripheral blood mononuclear cell (PBMC) fractions', 'atherogenesis, interferon-inducible protein-10 (IP-10) and sCD40L declined in plasma']","[{'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0311277', 'cui_str': 'Abdominal Obesity'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0151671', 'cui_str': 'Glucose tolerance decreased'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0086574', 'cui_str': 'Lymphoid Cells'}, {'cui': 'C0441731', 'cui_str': 'Type 3'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C1563937', 'cui_str': 'Atherogenesis'}, {'cui': 'C0056978', 'cui_str': 'CXCL10 Chemokine'}, {'cui': 'C1533698', 'cui_str': 'Nitric Oxide Synthase, Type II'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}]",21.0,0.139292,Other immune white cells in AT and peripheral blood mononuclear cell (PBMC) fractions did not change with treatment compared to placebo (p>0.05); although ILC-2 declined in PBMCs (p = 0.007) in the sitagliptin treatment group.,"[{'ForeName': 'Fred R', 'Initials': 'FR', 'LastName': 'Sattler', 'Affiliation': 'Department of Medicine, University of Southern California Keck School of Medicine, Los Angeles, California, United States of America.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Mert', 'Affiliation': 'Department of Preventive Medicine, University of Southern California Keck School of Medicine, Los Angeles, California, United States of America.'}, {'ForeName': 'Ishwarya', 'Initials': 'I', 'LastName': 'Sankaranarayanan', 'Affiliation': 'Department of Molecular Microbiology and Immunology, University of Southern California Keck School of Medicine, Los Angeles, California, United States of America.'}, {'ForeName': 'Wendy J', 'Initials': 'WJ', 'LastName': 'Mack', 'Affiliation': 'Department of Preventive Medicine, University of Southern California Keck School of Medicine, Los Angeles, California, United States of America.'}, {'ForeName': 'Lauriane', 'Initials': 'L', 'LastName': 'Galle-Treger', 'Affiliation': 'Department of Molecular Microbiology and Immunology, University of Southern California Keck School of Medicine, Los Angeles, California, United States of America.'}, {'ForeName': 'Evelyn', 'Initials': 'E', 'LastName': 'Gonzalez', 'Affiliation': 'Department of Medicine, University of Southern California Keck School of Medicine, Los Angeles, California, United States of America.'}, {'ForeName': 'Lilit', 'Initials': 'L', 'LastName': 'Baronikian', 'Affiliation': 'Department of Medicine, University of Southern California Keck School of Medicine, Los Angeles, California, United States of America.'}, {'ForeName': 'Kyuwan', 'Initials': 'K', 'LastName': 'Lee', 'Affiliation': 'Ostrow School of Dentistry, Division of Physical Therapy and Biokinesiology, University of Southern California, Los Angeles, California, United States of America.'}, {'ForeName': 'Pedram Shafiei', 'Initials': 'PS', 'LastName': 'Jahani', 'Affiliation': 'Department of Molecular Microbiology and Immunology, University of Southern California Keck School of Medicine, Los Angeles, California, United States of America.'}, {'ForeName': 'Howard N', 'Initials': 'HN', 'LastName': 'Hodis', 'Affiliation': 'Department of Medicine, University of Southern California Keck School of Medicine, Los Angeles, California, United States of America.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Dieli-Conwright', 'Affiliation': 'Ostrow School of Dentistry, Division of Physical Therapy and Biokinesiology, University of Southern California, Los Angeles, California, United States of America.'}, {'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Akbari', 'Affiliation': 'Department of Molecular Microbiology and Immunology, University of Southern California Keck School of Medicine, Los Angeles, California, United States of America.'}]",PloS one,['10.1371/journal.pone.0237496']
2610,32881921,Progressive active mobilization with dose control and training load in critically ill patients (PROMOB): Protocol for a randomized controlled trial.,"The dose of progressive active mobilization is still uncertain. The purpose of this study is to identify if the addition of a protocol of progressive active mobilization with dose and training load control to usual care is effective in reducing the length of stay in intensive care unit (ICU) and the improvement of the functioning, incidence of ICU-acquired weakness (ICUAW), mechanical ventilation duration and mortality rate in patients hospitalized in ICU. It is Double-blind randomised clinical trial. The setting for this trial will be medical and surgical ICU of a university hospital. The study participants will be 118 patients aged> 18 years admitted to ICU for less than 72 hours. Participants will be randomized to either an experimental or control group. The experimental group will undertake addition of a protocol of progressive active mobilization with dose and training load control to usual care, while the control group will undertake only usual care. The primary outcome will be length of ICU stay. The secondary outcomes will be Cross-sectional area and muscle thickness of the rectus femoris and biceps brachii, Change in muscle strength from the baseline, Functional Status, incidence of ICUAW, Days with mechanical ventilation and Mortality. All statistical analyses will be conducted following intention-to-treat principles. It has a detailed description of the dose of exercise, was designed with the strictest methodological criteria. These characteristics allow to investigate with greater certainty the results progressive active mobilization in critical patients, allowing replication and future combinations in meta-analyzes.",2020,"The secondary outcomes will be Cross-sectional area and muscle thickness of the rectus femoris and biceps brachii, Change in muscle strength from the baseline, Functional Status, incidence of ICUAW, Days with mechanical ventilation and Mortality.","['118 patients aged> 18 years admitted to ICU for less than 72 hours', 'critically ill patients (PROMOB', 'patients hospitalized in ICU']","['progressive active mobilization with dose and training load control to usual care, while the control group will undertake only usual care']","['length of stay in intensive care unit (ICU', 'Cross-sectional area and muscle thickness of the rectus femoris and biceps brachii, Change in muscle strength from the baseline, Functional Status, incidence of ICUAW, Days with mechanical ventilation and Mortality', 'functioning, incidence of ICU-acquired weakness (ICUAW), mechanical ventilation duration and mortality rate', 'length of ICU stay']","[{'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0583239', 'cui_str': 'Admission to intensive care unit'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C1292423', 'cui_str': '72 hours'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}]","[{'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0584894', 'cui_str': 'Rectus femoris muscle structure'}, {'cui': 'C0559499', 'cui_str': 'Biceps brachii muscle structure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C4087120', 'cui_str': 'Intensive care unit acquired weakness'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1444754', 'cui_str': 'Length'}]",118.0,0.1781,"The secondary outcomes will be Cross-sectional area and muscle thickness of the rectus femoris and biceps brachii, Change in muscle strength from the baseline, Functional Status, incidence of ICUAW, Days with mechanical ventilation and Mortality.","[{'ForeName': 'Rodrigo Santos de', 'Initials': 'RS', 'LastName': 'Queiroz', 'Affiliation': 'Program in Medicine and Health of the Faculty of Medicine, Federal University of Bahia, Salvador, Brazil.'}, {'ForeName': 'Micheli Bernardone', 'Initials': 'MB', 'LastName': 'Saquetto', 'Affiliation': 'Department of Physical Therapy, Institute of Health Sciences, Federal University of Bahia, Salvador, Brazil.'}, {'ForeName': 'Bruno Prata', 'Initials': 'BP', 'LastName': 'Martinez', 'Affiliation': 'Department of Physical Therapy, Institute of Health Sciences, Federal University of Bahia, Salvador, Brazil.'}, {'ForeName': 'Bianca Bigogno Reis', 'Initials': 'BBR', 'LastName': 'Cazeta', 'Affiliation': 'Program in Medicine and Health of the Faculty of Medicine, Federal University of Bahia, Salvador, Brazil.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Hodgson', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, Australia.'}, {'ForeName': 'Mansueto', 'Initials': 'M', 'LastName': 'Gomes-Neto', 'Affiliation': 'Department of Physical Therapy, Institute of Health Sciences, Federal University of Bahia, Salvador, Brazil.'}]",PloS one,['10.1371/journal.pone.0238352']
2611,32891527,Wearable and interactive technology to share fitness goals results in weight loss but not improved diabetes outcomes.,"BACKGROUND AND PURPOSE


To investigate the effects of adding virtual activity groups to a multicomponent ambulatory activity monitoring intervention in managing chronic conditions such as obesity and type 2 diabetes.
METHODS


We randomized 120 subjects with type 2 diabetes to receive an activity monitor with or without placement into virtual activity groups. We monitored subjects over six months and collected HbA1c, weight, step count, blood pressure, and SF-36 questionnaire data.
RESULTS


All subjects lost significant weight over the course of the study (p = 0.005); however, there was no statistically significant difference in mean weight loss between two groups (p = 0.520). HbA1c decreased in both groups, but was not statistically significant (p = 0.084). Daily step counts were similar between groups (p = 0.633), but both groups did decrease significantly over time (p = 0.004). There was no linear correlation between daily step count and HbA1c (p = 0.609), but there was between daily step count and weight (p = 0.016) although this only accounted for 5.6% of weight loss. There were no significant differences found for blood pressure and Rand SF36 measures between groups or times, or group-time interactions with two exceptions. The SF36 Role functioning/emotional measure showed an interaction between group and time (p = 0.039) and the SF36 Health Change measure had a significant difference due to time irrespective of group (p < 0.0001). Compliance remained high, with 93.8% of subjects actively participating at the conclusion of the study.
CONCLUSIONS


Activity monitoring with in-person goal-setting and scripted feedback over six months was associated with significant weight loss with or without virtual support groups.",2020,The SF36 Role functioning/emotional measure showed an interaction between group and time (p = 0.039) and the SF36 Health Change measure had a significant difference due to time irrespective of group (p < 0.0001).,['120 subjects with type 2 diabetes to receive an'],"['multicomponent ambulatory activity monitoring intervention', 'activity monitor with or without placement into virtual activity groups']","['weight loss', 'Daily step counts', 'collected HbA1c, weight, step count, blood pressure, and SF-36 questionnaire data', 'mean weight loss', 'blood pressure and Rand SF36 measures', 'SF36 Health Change measure', 'HbA1c']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4264352', 'cui_str': 'Activity Trackers'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",120.0,0.0201026,The SF36 Role functioning/emotional measure showed an interaction between group and time (p = 0.039) and the SF36 Health Change measure had a significant difference due to time irrespective of group (p < 0.0001).,"[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Lystrup', 'Affiliation': '99th MDG, Nellis Air Force Base, NV, 89191, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Carlsen', 'Affiliation': '99th MDG, Nellis Air Force Base, NV, 89191, USA.'}, {'ForeName': 'Danny J', 'Initials': 'DJ', 'LastName': 'Sharon', 'Affiliation': 'San Antonio, TX, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Crawford', 'Affiliation': '99th MDG, Nellis Air Force Base, NV, 89191, USA. Electronic address: drpaulcrawford@aol.com.'}]",Obesity research & clinical practice,['10.1016/j.orcp.2020.08.006']
2612,32892756,"Predictors of postprandial glycaemia, insulinaemia and insulin resistance in adolescents.","Postprandial glycaemia and insulinaemia are important risk factors for type 2 diabetes. The prevalence of insulin resistance in adolescents is increasing, but it is unknown how adolescent participant characteristics such as BMI, waist circumference, fitness and maturity offset may explain responses to a standard meal. The aim of the present study was to examine how such participant characteristics affect the postprandial glycaemic and insulinaemic responses to an ecologically valid mixed meal. Data from the control trials of three separate randomised, crossover experiments were pooled, resulting in a total of 108 participants (fifty-two boys, fifty-six girls; aged 12·5 (SD 0·6) years; BMI 19·05 (SD 2·66) kg/m2). A fasting blood sample was taken for the calculation of fasting insulin resistance, using the homoeostatic model assessment of insulin resistance (HOMA-IR). Further capillary blood samples were taken before and 30, 60 and 120 min after a standardised lunch, providing 1·5 g/kg body mass of carbohydrate, for the quantification of blood glucose and plasma insulin total AUC (tAUC). Hierarchical multiple linear regression demonstrated significant predictors for plasma insulin tAUC were waist circumference, physical fitness and HOMA-IR (F(3,98) = 36·78, P < 0·001, adjusted R2 = 0·515). The variance in blood glucose tAUC was not significantly explained by the predictors used (F(7,94) = 1·44, P = 0·198). Significant predictors for HOMA-IR were BMI and maturity offset (F(2,102) = 14·06, P < 0·001, adjusted R2 = 0·021). In summary, the key findings of the study are that waist circumference, followed by physical fitness, best explained the insulinaemic response to an ecologically valid standardised meal in adolescents. This has important behavioural consequences because these variables can be modified.",2020,"Hierarchical multiple linear regression demonstrated significant predictors for plasma insulin tAUC were waist circumference, physical fitness and HOMA-IR (F(3, 98)=36.78, p<.001, Adj.","['108 participants (52 boys, 56 girls; age', 'adolescents']",[],"['plasma insulin tAUC were waist circumference, physical fitness and HOMA-IR', 'postprandial glycaemic and insulinaemic responses', 'blood glucose and plasma insulin total area under the curve (tAUC', 'blood glucose tAUC', 'postprandial glycaemia, insulinaemia and insulin resistance', 'HOMA-IR were BMI and maturity offset', 'Postprandial glycaemia and insulinaemia']","[{'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]",[],"[{'cui': 'C0857690', 'cui_str': 'Plasma insulin'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205286', 'cui_str': 'Mature'}]",108.0,0.0171593,"Hierarchical multiple linear regression demonstrated significant predictors for plasma insulin tAUC were waist circumference, physical fitness and HOMA-IR (F(3, 98)=36.78, p<.001, Adj.","[{'ForeName': 'Ryan A', 'Initials': 'RA', 'LastName': 'Williams', 'Affiliation': 'Exercise and Health Research Group, Sport, Health and Performance Enhancement (SHAPE) Research Centre, Department of Sport Science, Nottingham Trent University, NottinghamNG11 8NS, UK.'}, {'ForeName': 'Karah J', 'Initials': 'KJ', 'LastName': 'Dring', 'Affiliation': 'Exercise and Health Research Group, Sport, Health and Performance Enhancement (SHAPE) Research Centre, Department of Sport Science, Nottingham Trent University, NottinghamNG11 8NS, UK.'}, {'ForeName': 'Simon B', 'Initials': 'SB', 'LastName': 'Cooper', 'Affiliation': 'Exercise and Health Research Group, Sport, Health and Performance Enhancement (SHAPE) Research Centre, Department of Sport Science, Nottingham Trent University, NottinghamNG11 8NS, UK.'}, {'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'Morris', 'Affiliation': 'Exercise and Health Research Group, Sport, Health and Performance Enhancement (SHAPE) Research Centre, Department of Sport Science, Nottingham Trent University, NottinghamNG11 8NS, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Sunderland', 'Affiliation': 'Exercise and Health Research Group, Sport, Health and Performance Enhancement (SHAPE) Research Centre, Department of Sport Science, Nottingham Trent University, NottinghamNG11 8NS, UK.'}, {'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'Nevill', 'Affiliation': 'Exercise and Health Research Group, Sport, Health and Performance Enhancement (SHAPE) Research Centre, Department of Sport Science, Nottingham Trent University, NottinghamNG11 8NS, UK.'}]",The British journal of nutrition,['10.1017/S0007114520003505']
2613,32871029,"High-dose dexamethasone plus recombinant human thrombopoietin vs high-dose dexamethasone alone as frontline treatment for newly diagnosed adult primary immune thrombocytopenia: A prospective, multicenter, randomized trial.","We conducted a prospective, multicenter, randomized, controlled clinical trial to compare the efficacy and safety of high-dose dexamethasone (HD-DXM) plus recombinant human thrombopoietin (rhTPO), vs HD-DXM alone in newly diagnosed adult immune thrombocytopenia (ITP) patients. Enrolled patients were randomly assigned to receive DXM plus rhTPO or DXM monotherapy. Another 4-day course of DXM was repeated if response was not achieved by day 10 in both arms. One hundred patients in the HD-DXM plus rhTPO arm and 96 patients in the HD-DXM monotherapy arm were included in the full analysis set. So, HD-DXM plus rhTPO resulted in a higher incidence of initial response (89.0% vs 66.7%, P < .001) and complete response (CR, 75.0% vs 42.7%, P < .001) compared with HD-DXM monotherapy. Response rate at 6 months was also higher in the HD-DXM plus rhTPO arm than that in the HD-DXM monotherapy arm (51.0% vs 36.5%, P = .02; sustained CR: 46.0% vs 32.3%, P = .043). Throughout the follow-up period, the overall duration of response was greater in the HD-DXM plus rhTPO arm compared to the HD-DXM monotherapy arm (P = .04), as estimated by the Kaplan-Meier analysis. The study drugs were generally well tolerated. In conclusion, the combination of HD-DXM with rhTPO significantly improved the initial response and yielded favorable SR in newly diagnosed ITP patients, thus could be further validated as a frontline treatment for ITP. This study is registered as clinicaltrials.gov identifier: NCT01734044.",2020,"Throughout the follow-up period, the overall duration of response was greater in the HD-DXM plus rhTPO arm compared to the HD-DXM monotherapy arm (P = 0.04), as estimated by the Kaplan-Meier analysis.","['newly diagnosed adult immune thrombocytopenia (ITP) patients', 'One hundred patients in the HD-DXM plus rhTPO arm and 96 patients in the HD-DXM monotherapy arm were included in the full analysis set', 'newly diagnosed adult primary immune thrombocytopenia', 'newly diagnosed ITP patients']","['dexamethasone (HD-DXM) plus recombinant human thrombopoietin (rhTPO) versus HD-DXM alone', 'DXM', 'DXM plus rhTPO or DXM monotherapy', 'dexamethasone', 'dexamethasone plus recombinant human thrombopoietin']","['initial response and yielded favorable SR', 'Response rate', 'efficacy and safety', 'initial response', 'overall duration of response', 'tolerated', 'complete response']","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0242584', 'cui_str': 'Autoimmune thrombocytopenia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0040052', 'cui_str': 'Thrombopoietin'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0040052', 'cui_str': 'Thrombopoietin'}]","[{'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}]",,0.108466,"Throughout the follow-up period, the overall duration of response was greater in the HD-DXM plus rhTPO arm compared to the HD-DXM monotherapy arm (P = 0.04), as estimated by the Kaplan-Meier analysis.","[{'ForeName': 'Yafei', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': 'Department of Hematology, Qilu Hospital, Cheeloo College of Medicine, Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Miaomiao', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'Department of Pediatrics, The Second Hospital, Cheeloo College of Medicine, Shandong University, Jinan, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Hou', 'Affiliation': 'Department of Hematology, Qilu Hospital, Cheeloo College of Medicine, Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Qin', 'Affiliation': 'Department of Hematology, Qilu Hospital, Cheeloo College of Medicine, Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Qingshu', 'Initials': 'Q', 'LastName': 'Zeng', 'Affiliation': 'Department of Hematology, The First Affiliated Hospital of Anhui Medical University, Hefei, China.'}, {'ForeName': 'Wenzheng', 'Initials': 'W', 'LastName': 'Yu', 'Affiliation': 'Department of Hematology, Binzhou Medical University Hospital, Binzhou, China.'}, {'ForeName': 'Xinhong', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': 'Department of Hematology, The First Affiliated Hospital of Xinjiang Medical University, Urumqi, China.'}, {'ForeName': 'Jingxia', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Department of Hematology, Liaocheng People's Hospital, Liaocheng, China.""}, {'ForeName': 'Xiaomin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""Department of Hematology, Xinjiang Uiger Municipal People's Hospital, Urumqi, China.""}, {'ForeName': 'Guoqiang', 'Initials': 'G', 'LastName': 'Liu', 'Affiliation': 'Department of Hematology, Shengli Oilfield Central Hospital, Dongying, China.'}, {'ForeName': 'Xiaoxia', 'Initials': 'X', 'LastName': 'Chu', 'Affiliation': 'Department of Hematology, Yantai Yuhuangding Hospital, Yantai, China.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': ""Department of Hematology, Xijing Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Feng', 'Affiliation': 'Department of Hematology, The Second Affiliated Hospital of Guangzhou Medical University, Guangdong, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Zhou', 'Affiliation': 'Department of Hematology, Military General Hospital, Jinan, China.'}, {'ForeName': 'Zhaogang', 'Initials': 'Z', 'LastName': 'Sun', 'Affiliation': 'Department of Hematology, Taian City Central Hospital, Taian, China.'}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': ""Department of Hematology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Hematology, Shandong Provincial Hospital Affiliated to Shandong University, Jinan, China.'}, {'ForeName': 'Zhencheng', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Hematology, Zibo Central Hospital, Zibo, China.'}, {'ForeName': 'Xuehong', 'Initials': 'X', 'LastName': 'Ran', 'Affiliation': ""Department of Hematology, Weifang People's Hospital, Weifang, China.""}, {'ForeName': 'Hongguo', 'Initials': 'H', 'LastName': 'Zhao', 'Affiliation': 'Department of Hematology, The Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Hematology, Qingdao Municipal Hospital, Qingdao, China.'}, {'ForeName': 'Haiyan', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': ""Department of Hematology, Linyi People's Hospital, Linyi, China.""}, {'ForeName': 'Kehong', 'Initials': 'K', 'LastName': 'Bi', 'Affiliation': 'Department of Hematology, Shandong Provincial Qianfoshan Hospital, Jinan, China.'}, {'ForeName': 'Daqi', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': 'Department of Hematology, Jinan Central Hospital, Jinan, China.'}, {'ForeName': 'Chenglu', 'Initials': 'C', 'LastName': 'Yuan', 'Affiliation': 'Department of Hematology, Qilu Hospital (Qingdao), Shandong University, Qingdao, China.'}, {'ForeName': 'Ruirong', 'Initials': 'R', 'LastName': 'Xu', 'Affiliation': 'Department of Hematology, Shandong Provincial Hospital of Traditional Chinese Medicine, Jinan, China.'}, {'ForeName': 'Yili', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Hematology, Weihai Municipal Hospital, Weihai, China.'}, {'ForeName': 'Yuhong', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Department of Hematology, Zhejiang Provincial Hospital of TCM, Hangzhou, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Peng', 'Affiliation': 'Department of Hematology, Qilu Hospital, Cheeloo College of Medicine, Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Xin-Guang', 'Initials': 'XG', 'LastName': 'Liu', 'Affiliation': 'Department of Hematology, Qilu Hospital, Cheeloo College of Medicine, Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Hou', 'Affiliation': 'Department of Hematology, Qilu Hospital, Cheeloo College of Medicine, Shandong University, Jinan, Shandong, China.'}]",American journal of hematology,['10.1002/ajh.25989']
2614,32880842,Cost analysis of a randomized trial of Getting to Outcomes implementation support for a teen pregnancy prevention program offered in Boys and Girls Clubs in Alabama and Georgia.,"Implementation support can improve outcomes of evidence-based programs (EBP) for adolescents, but with a cost. To assist in determining whether this cost is worthwhile, this study estimated the cost of adding Getting To Outcomes© (GTO) implementation support to a teen pregnancy and sexually transmitted infection prevention EBP called Making Proud Choices (MPC) in 32 Boys and Girls Clubs (BGCs) in Alabama and Georgia. Enhancing Quality Interventions Promoting Healthy Sexuality (EQUIPS) was a 2-year, cluster-randomized controlled trial comparing MPC with MPC + GTO. We used micro-costing to estimate costs and captured MPC and GTO time from activity logs completed by GTO staff. Key resource use and cost components were compared between the randomized groups, years, and states (to capture different community site circumstances) using 2-sample t tests. There were no significant differences between randomized groups in attendees per site, resource use, or costs for either year. However, there were significant differences between states. Adding GTO to MPC increased the societal costs per attendee from $67 to $144 (2015 US dollars) in Georgia and from $106 to $314 in Alabama. The higher Alabama cost was due to longer travel distances and to more BGC staff time spent on GTO in that state. GTO also improved adherence, classroom delivery, and condom-use intentions more in Alabama youth. Thus, Alabama's GTO-related BGC staff time costs may be better estimates of effective GTO. If teen childbearing costs taxpayers approximately $20,000 per teen birth, adding GTO to MPC would be worthwhile to society if it prevented one more teen birth per 140 attendees than MPC alone.Trial registration. ClinicalTrials.gov , NCT01818791. Registered March 26, 2013, https://clinicaltrials.gov/ct2/show/NCT01818791?term=NCT01818791&draw=2&rank=1.",2020,Adding GTO to MPC increased the societal costs per attendee from $67 to $144 (2015 US dollars) in Georgia and from $106 to $314 in Alabama.,"['32 Boys and Girls Clubs (BGCs) in Alabama and Georgia', 'Healthy Sexuality (EQUIPS', 'Boys and Girls Clubs in Alabama and Georgia']",[],"['societal costs per attendee', 'adherence, classroom delivery, and condom-use intentions more in Alabama youth', 'attendees per site, resource use, or costs for either year']","[{'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0149651', 'cui_str': 'Clubbing'}, {'cui': 'C0001895', 'cui_str': 'Alabama'}, {'cui': 'C0017452', 'cui_str': 'Georgia state'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}]",[],"[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0001895', 'cui_str': 'Alabama'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0439234', 'cui_str': 'year'}]",,0.124449,Adding GTO to MPC increased the societal costs per attendee from $67 to $144 (2015 US dollars) in Georgia and from $106 to $314 in Alabama.,"[{'ForeName': 'Patricia M', 'Initials': 'PM', 'LastName': 'Herman', 'Affiliation': 'RAND Corporation, 1776 Main Street, PO Box 2138, Santa Monica, CA, 90407-2138, USA. pherman@rand.org.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Chinman', 'Affiliation': 'RAND Corporation, 4570 Fifth Ave #600, Pittsburgh, PA, 15213, USA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Ebener', 'Affiliation': 'RAND Corporation, 1776 Main Street, PO Box 2138, Santa Monica, CA, 90403, USA.'}, {'ForeName': 'Patrick S', 'Initials': 'PS', 'LastName': 'Malone', 'Affiliation': 'Malone Quantitative, Durham, NC, 27705, USA.'}, {'ForeName': 'Joie', 'Initials': 'J', 'LastName': 'Acosta', 'Affiliation': 'RAND Corporation, 1200 S Hayes St, Arlington, VA, 22202, USA.'}]",Prevention science : the official journal of the Society for Prevention Research,['10.1007/s11121-020-01162-y']
2615,32877425,Gamification as an approach to improve resilience and reduce attrition in mobile mental health interventions: A randomized controlled trial.,"Forty percent of all general-practitioner appointments are related to mental illness, although less than 35% of individuals have access to therapy and psychological care, indicating a pressing need for accessible and affordable therapy tools. The ubiquity of smartphones offers a delivery platform for such tools. Previous research suggests that gamification-turning intervention content into a game format-could increase engagement with prevention and early-stage mobile interventions. This study aimed to explore the effects of a gamified mobile mental health intervention on improvements in resilience, in comparison with active and inactive control conditions. Differences between conditions on changes in personal growth, anxiety and psychological wellbeing, as well as differences in attrition rates, were also assessed. The eQuoo app was developed and published on all leading mobile platforms. The app educates users about psychological concepts including emotional bids, generalization, and reciprocity through psychoeducation, storytelling, and gamification. In total, 358 participants completed in a 5-week, 3-armed (eQuoo, ""treatment as usual"" cognitive behavioral therapy journal app, no-intervention waitlist) randomized controlled trial. Relevant scales were administered to all participants on days 1, 17, and 35. Repeated-measures ANOVA revealed statistically significant increases in resilience in the test group compared with both control groups over 5 weeks. The app also significantly increased personal growth, positive relations with others, and anxiety. With 90% adherence, eQuoo retained 21% more participants than the control or waitlist groups. Intervention delivered via eQuoo significantly raised mental well-being and decreased self-reported anxiety while enhancing adherence in comparison with the control conditions. Mobile apps using gamification can be a valuable and effective platform for well-being and mental health interventions and may enhance motivation and reduce attrition. Future research should measure eQuoo's effect on anxiety with a more sensitive tool and examine the impact of eQuoo on a clinical population.",2020,Intervention delivered via eQuoo significantly raised mental well-being and decreased self-reported anxiety while enhancing adherence in comparison with the control conditions.,"['mobile mental health interventions', '358 participants completed in a 5-week, 3-armed (eQuoo, ""treatment as usual"" cognitive behavioral therapy journal app, no-intervention waitlist) randomized controlled trial']",['gamified mobile mental health intervention'],"['personal growth, anxiety and psychological wellbeing', 'resilience', 'personal growth, positive relations with others, and anxiety', 'attrition rates']","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0162443', 'cui_str': 'Journals as Topic'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}]",358.0,0.122714,Intervention delivered via eQuoo significantly raised mental well-being and decreased self-reported anxiety while enhancing adherence in comparison with the control conditions.,"[{'ForeName': 'Silja', 'Initials': 'S', 'LastName': 'Litvin', 'Affiliation': 'Department of General Psychology II (Emotion and Motivation), Ludwig Maximilian University of Munich, Munich, Germany.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Saunders', 'Affiliation': 'Research Department of Clinical, Educational and Health Psychology, Centre for Outcomes Research and Effectiveness, University College London, London, United Kingdom.'}, {'ForeName': 'Markus A', 'Initials': 'MA', 'LastName': 'Maier', 'Affiliation': 'Department of General Psychology II (Emotion and Motivation), Ludwig Maximilian University of Munich, Munich, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Lüttke', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, University of Tübingen, Tübingen, Germany.'}]",PloS one,['10.1371/journal.pone.0237220']
2616,32877859,The influence of center line width during the crossover hop test.,"OBJECTIVES


To assess the influence of center line width on crossover hop for distance test (XHOP) performance.
DESIGN


Repeated measures.
SETTING


University laboratory.
PARTICIPANTS


33 physically active females without history of a ligamentous knee injury (age: 22.5 ± 2.3 years).
MAIN OUTCOME MEASURES


Hop distance was measured during four XHOP conditions with variations in center line width: 2.54 cm (narrow), 15 cm (standard), 12.5% of the participants' height (HT1), and 25% of the participants' height (HT2). A repeated measures ANOVA was used to evaluate differences in hop distance for XHOP condition (narrow, standard, HT1, and HT2).
RESULTS


Differences in hop distance were shown on XHOP condition (p < 0.001). Post hoc tests identified differences in hop distance between narrow and HT2 (p < 0.001, Effect size (ES) = 0.78), standard and HT2 (p < 0.001, ES = 0.57), and HT1 and HT2 (p < 0.001, ES = 0.58) conditions, respectively.
CONCLUSIONS


No differences in hop distance were identified between narrow and standard center line width XHOP conditions in healthy females. Decreased hop distance was shown when center line width was normalized to 25% of participant height in comparison to all other XHOP conditions, with medium effect sizes. This study highlights hop distance outcomes based on different XHOP center line widths, normalizing the XHOP according to height, and potential implications for frontal plane knee loading during the XHOP in healthy individuals.",2020,"Post hoc tests identified differences in hop distance between narrow and HT2 (p < 0.001, Effect size (ES) = 0.78), standard and HT2 (p < 0.001, ES = 0.57), and HT1 and HT2 (p < 0.001, ES = 0.58) conditions, respectively.
","['33 physically active females without history of a ligamentous knee injury (age: 22.5\xa0±\xa02.3 years', 'healthy females', 'University laboratory', 'healthy individuals']",[],"['distance test (XHOP) performance', 'XHOP condition', 'XHOP condition (narrow, standard, HT1, and HT2']","[{'cui': 'C0556453', 'cui_str': 'Physically active'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0022744', 'cui_str': 'Injury of knee'}, {'cui': 'C4517649', 'cui_str': '22.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",[],"[{'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0332463', 'cui_str': 'Narrowed structure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0450565', 'cui_str': 'HT1'}, {'cui': 'C0450566', 'cui_str': 'HT2'}]",33.0,0.0332208,"Post hoc tests identified differences in hop distance between narrow and HT2 (p < 0.001, Effect size (ES) = 0.78), standard and HT2 (p < 0.001, ES = 0.57), and HT1 and HT2 (p < 0.001, ES = 0.58) conditions, respectively.
","[{'ForeName': 'Brandon M', 'Initials': 'BM', 'LastName': 'Ness', 'Affiliation': 'Department of Physical Therapy, University of South Dakota, 414 E Clark Street, Vermillion, SD, 57069, USA; Doctor of Physical Therapy Program, Department of Public Health and Community Medicine, Tufts University School of Medicine, 136 Harrison Ave, Boston, MA, 02111, USA. Electronic address: Brandon.Ness@tufts.edu.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Albright', 'Affiliation': 'Department of Physical Therapy, University of South Dakota, 414 E Clark Street, Vermillion, SD, 57069, USA.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Ehlers', 'Affiliation': 'Department of Physical Therapy, University of South Dakota, 414 E Clark Street, Vermillion, SD, 57069, USA.'}, {'ForeName': 'Taylor', 'Initials': 'T', 'LastName': 'Glasoe', 'Affiliation': 'Department of Physical Therapy, University of South Dakota, 414 E Clark Street, Vermillion, SD, 57069, USA.'}, {'ForeName': 'Shanna', 'Initials': 'S', 'LastName': 'Selby', 'Affiliation': 'Department of Physical Therapy, University of South Dakota, 414 E Clark Street, Vermillion, SD, 57069, USA.'}, {'ForeName': 'Kory', 'Initials': 'K', 'LastName': 'Zimney', 'Affiliation': 'Department of Physical Therapy, University of South Dakota, 414 E Clark Street, Vermillion, SD, 57069, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kernozek', 'Affiliation': 'Department of Health Professions, Physical Therapy Program, La Crosse Institute for Movement Science, University of Wisconsin - La Crosse, 1725 State Street, La Crosse, WI, 54601, USA.'}]",Physical therapy in sport : official journal of the Association of Chartered Physiotherapists in Sports Medicine,['10.1016/j.ptsp.2020.08.005']
2617,32877884,Reduced morbidity by using LigaSure compared to conventional inguinofemoral lymphadenectomy in vulvar cancer patients: A randomized controlled trial.,"BACKGROUND


Inguinofemoral lymphadenectomy (IFL) is part of the surgical treatment of different malignancies of the genital tract and/or the lower limb including vulvar carcinoma, penile carcinoma and melanoma. IFL is associated with morbidity in up to 85% of the patients. The aims of this MAMBO-IC study (Morbidity And Measurement of the Body) are to study the feasibility of using LigaSure for IFL and to assess the differences in the incidence of short-term complications using LigaSure versus conventional IFL randomized within each individual patient.
METHODS


In this multicenter randomized controlled trial (RCT), women diagnosed with squamous cell carcinoma of the vulva with an indication for bilateral IFL were included. It was randomly assigned for which groin the LigaSure was used; the other groin was treated with conventional IFL (sharp/diathermia). We estimated the incidence of ≥1 complication(s) per groin using logistic regression and compared this between the two surgical methods, adjusting for possible confounders.
RESULTS


We included 40 groins of 20 patients. The estimated incidence of ≥1 complication(s) was 29% after LigaSure versus 70% after conventional IFL (risk difference 41% (95% CI 19-62), p < 0.001). Patients' reported restriction of daily living activities and maximum pain score were equal for both treatment methods. There were no differences in the surgeon reported workload scores.
CONCLUSIONS


This RCT shows that LigaSure for IFL is feasible and associated with significantly less short-term surgical complications compared to conventional IFL. Further studies with a larger sample size are needed to validate our findings. ISRCTN15057626.",2020,This RCT shows that LigaSure for IFL is feasible and associated with significantly less short-term surgical complications compared to conventional IFL.,"['40 groins of 20 patients', 'vulvar cancer patients', 'women diagnosed with squamous cell carcinoma of the vulva with an indication for bilateral IFL were included']","['conventional IFL (sharp/diathermia', 'Inguinofemoral lymphadenectomy (IFL', 'IFL', 'conventional inguinofemoral lymphadenectomy', 'LigaSure']","['restriction of daily living activities and maximum pain score', 'morbidity', 'estimated incidence of ≥1 complication(s']","[{'cui': 'C0018246', 'cui_str': 'Inguinal'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0375071', 'cui_str': 'Malignant tumor of vulva'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0280856', 'cui_str': 'Squamous cell carcinoma of vulva'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0398408', 'cui_str': 'Inguinofemoral lymphadenectomy'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0398408', 'cui_str': 'Inguinofemoral lymphadenectomy'}, {'cui': 'C1444775', 'cui_str': 'Sharp sensation quality'}]","[{'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",,0.247773,This RCT shows that LigaSure for IFL is feasible and associated with significantly less short-term surgical complications compared to conventional IFL.,"[{'ForeName': 'Anne-Floor W', 'Initials': 'AW', 'LastName': 'Pouwer', 'Affiliation': 'Department of Obstetrics and Gynaecology, Radboud Institute for Health Sciences, Radboud university Medical Center, Nijmegen, the Netherlands. Electronic address: Anne-Floor.W.Pouwer@radboudumc.nl.'}, {'ForeName': 'Henriette J', 'Initials': 'HJ', 'LastName': 'Arts', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Groningen, Department of Obstetrics and Gynaecology, the Netherlands.'}, {'ForeName': 'Corine M', 'Initials': 'CM', 'LastName': 'Koopmans', 'Affiliation': 'Department of Obstetrics and Gynaecology, Medisch Spectrum Twente, Enschede, the Netherlands.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'IntHout', 'Affiliation': 'Department for Health Evidence, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Johanna M A', 'Initials': 'JMA', 'LastName': 'Pijnenborg', 'Affiliation': 'Department of Obstetrics and Gynaecology, Radboud Institute for Health Sciences, Radboud university Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Joanne A', 'Initials': 'JA', 'LastName': 'de Hullu', 'Affiliation': 'Department of Obstetrics and Gynaecology, Radboud Institute for Health Sciences, Radboud university Medical Center, Nijmegen, the Netherlands.'}]",Surgical oncology,['10.1016/j.suronc.2020.08.011']
2618,32882163,"Prasugrel-based de-escalation of dual antiplatelet therapy after percutaneous coronary intervention in patients with acute coronary syndrome (HOST-REDUCE-POLYTECH-ACS): an open-label, multicentre, non-inferiority randomised trial.","BACKGROUND


A potent P2Y12 inhibitor-based dual antiplatelet therapy is recommended for up to 1 year in patients with acute coronary syndrome receiving percutaneous coronary intervention (PCI). The greatest benefit of the potent agent is during the early phase, whereas the risk of excess bleeding continues in the chronic maintenance phase. Therefore, de-escalation of antiplatelet therapy might achieve an optimal balance between ischaemia and bleeding. We aimed to investigate the safety and efficacy of a prasugrel-based dose de-escalation therapy.
METHODS


HOST-REDUCE-POLYTECH-ACS is a randomised, open-label, multicentre, non-inferiority trial done at 35 hospitals in South Korea. We enrolled patients with acute coronary syndrome receiving PCI. Patients meeting the core indication for prasugrel were randomly assigned (1:1) to the de-escalation group or conventional group using a web-based randomisation system. The assessors were masked to the treatment allocation. After 1 month of treatment with 10 mg prasugrel plus 100 mg aspirin daily, the de-escalation group received 5 mg prasugrel, while the conventional group continued to receive 10 mg. The primary endpoint was net adverse clinical events (all-cause death, non-fatal myocardial infarction, stent thrombosis, repeat revascularisation, stroke, and bleeding events of grade 2 or higher according to Bleeding Academic Research Consortium [BARC] criteria) at 1 year. The absolute non-inferiority margin for the primary endpoint was 2·5%. The key secondary endpoints were efficacy outcomes (cardiovascular death, myocardial infarction, stent thrombosis, and ischaemic stroke) and safety outcomes (bleeding events of BARC grade ≥2). The primary analysis was in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, NCT02193971.
RESULTS


From Sept 30, 2014, to Dec 18, 2018, 3429 patients were screened, of whom 1075 patients did not meet the core indication for prasugrel and 16 were excluded due to randomisation error. 2338 patients were randomly assigned to the de-escalation group (n=1170) or the conventional group (n=1168). The primary endpoint occurred in 82 patients (Kaplan-Meier estimate 7·2%) in the de-escalation group and 116 patients (10·1%) in the conventional group (absolute risk difference -2·9%, p non-inferiority <0·0001; hazard ratio 0·70 [95% CI 0·52-0·92], p equivalence =0·012). There was no increase in ischaemic risk in the de-escalation group compared with the conventional group (0·76 [0·40-1·45]; p=0·40), and the risk of bleeding events was significantly decreased (0·48 [0·32-0·73]; p=0·0007).
INTERPRETATION


In east Asian patients with acute coronary syndrome patients receiving PCI, a prasugrel-based dose de-escalation strategy from 1 month after PCI reduced the risk of net clinical outcomes up to 1 year, mainly driven by a reduction in bleeding without an increase in ischaemia.
FUNDING


Daiichi Sankyo, Boston Scientific, Terumo, Biotronik, Qualitech Korea, and Dio.",2020,"There was no increase in ischaemic risk in the de-escalation group compared with the conventional group (0·76 [0·40-1·45]; p=0·40), and the risk of bleeding events was significantly decreased (0·48 [0·32-0·73]; p=0·0007).
","['35 hospitals in South Korea', 'enrolled patients with acute coronary syndrome receiving PCI', 'patients with acute coronary syndrome (HOST-REDUCE-POLYTECH-ACS', '2338 patients', 'patients with acute coronary syndrome receiving percutaneous coronary intervention (PCI', 'From Sept 30, 2014, to Dec 18, 2018, 3429 patients were screened, of whom 1075 patients did not meet the core indication for prasugrel and 16 were excluded due to randomisation error', 'Patients meeting the core indication for prasugrel', 'east Asian patients with acute coronary syndrome patients receiving']","['prasugrel plus 100 mg aspirin', 'PCI', 'conventional group using a web-based randomisation system', 'P2Y12 inhibitor-based dual antiplatelet therapy', 'Prasugrel-based de-escalation of dual antiplatelet therapy', 'percutaneous coronary intervention', 'prasugrel-based dose de-escalation therapy']","['ischaemic risk', 'net adverse clinical events (all-cause death, non-fatal myocardial infarction, stent thrombosis, repeat revascularisation, stroke, and bleeding events of grade 2 or higher according to Bleeding Academic Research Consortium [BARC] criteria', 'safety and efficacy', 'risk of bleeding events', 'absolute non-inferiority margin', 'ischaemia', 'efficacy outcomes (cardiovascular death, myocardial infarction, stent thrombosis, and ischaemic stroke) and safety outcomes (bleeding events of BARC grade ≥2']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C1620287', 'cui_str': 'prasugrel'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}]","[{'cui': 'C1620287', 'cui_str': 'prasugrel'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0237666', 'cui_str': 'Inferiority feeling'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0441800', 'cui_str': 'Grade'}]",3429.0,0.163141,"There was no increase in ischaemic risk in the de-escalation group compared with the conventional group (0·76 [0·40-1·45]; p=0·40), and the risk of bleeding events was significantly decreased (0·48 [0·32-0·73]; p=0·0007).
","[{'ForeName': 'Hyo-Soo', 'Initials': 'HS', 'LastName': 'Kim', 'Affiliation': 'Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Jeehoon', 'Initials': 'J', 'LastName': 'Kang', 'Affiliation': 'Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Doyeon', 'Initials': 'D', 'LastName': 'Hwang', 'Affiliation': 'Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Jung-Kyu', 'Initials': 'JK', 'LastName': 'Han', 'Affiliation': 'Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Han-Mo', 'Initials': 'HM', 'LastName': 'Yang', 'Affiliation': 'Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Hyun-Jae', 'Initials': 'HJ', 'LastName': 'Kang', 'Affiliation': 'Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Bon-Kwon', 'Initials': 'BK', 'LastName': 'Koo', 'Affiliation': 'Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Jay Young', 'Initials': 'JY', 'LastName': 'Rhew', 'Affiliation': 'Presbyterian Medical Center, Jeonju, South Korea.'}, {'ForeName': 'Kook-Jin', 'Initials': 'KJ', 'LastName': 'Chun', 'Affiliation': 'Pusan National University Yangsan Hospital, Yangsan, South Korea.'}, {'ForeName': 'Young-Hyo', 'Initials': 'YH', 'LastName': 'Lim', 'Affiliation': 'Hanyang University Seoul Hospital, Seoul, South Korea.'}, {'ForeName': 'Jung Min', 'Initials': 'JM', 'LastName': 'Bong', 'Affiliation': 'Hanlim General Hospital, Incheon, South Korea.'}, {'ForeName': 'Jang-Whan', 'Initials': 'JW', 'LastName': 'Bae', 'Affiliation': 'Chungbuk National University, Cheongju, South Korea.'}, {'ForeName': 'Bong Ki', 'Initials': 'BK', 'LastName': 'Lee', 'Affiliation': 'Kangwon National University, Chuncheon, South Korea.'}, {'ForeName': 'Kyung Woo', 'Initials': 'KW', 'LastName': 'Park', 'Affiliation': 'Seoul National University Hospital, Seoul, South Korea. Electronic address: kwparkmd@snu.ac.kr.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(20)31791-8']
2619,32882310,C5 Inhibitor Avacincaptad Pegol for Geographic Atrophy Due to Age-Related Macular Degeneration: A Randomized Pivotal Phase 2/3 Trial.,"PURPOSE


The complement pathway may play a key role in the pathogenesis of age-related macular degeneration (AMD). The safety and efficacy of avacincaptad pegol (Zimura, IVERIC bio Inc, New York, NY), a C5 inhibitor, were assessed in participants with geographic atrophy (GA) secondary to AMD (GATHER1 Study).
DESIGN


International, prospective, randomized, double-masked, sham-controlled, pivotal phase 2/3 clinical trial.
PARTICIPANTS


A total of 286 participants with GA secondary to AMD.
MAIN OUTCOME MEASURES


The primary efficacy endpoint was the mean rate of change in GA over 12 months measured by fundus autofluorescence (FAF) at 3 timepoints: baseline, month 6, and month 12.
RESULTS


The reduction in the mean rate of GA growth (square root transformation) over 12 months was 27.4% (P = 0.0072) for the avacincaptad pegol 2 mg cohort and 27.8% (P = 0.0051) for the avacincaptad pegol 4 mg cohort compared with their corresponding sham cohorts. The results for both dose groups were statistically significant. Avacincaptad pegol was generally well tolerated after monthly administration over 12 months. There were no avacincaptad pegol-related adverse events (AEs) or inflammation. Further, there were no ocular serious AEs (SAEs) and no cases of endophthalmitis. The most frequent ocular AEs were related to the injection procedure.
CONCLUSIONS


Intravitreal administration of avacincaptad pegol 2 mg and 4 mg led to a significant reduction of GA growth in eyes with AMD over a 12-month period. Because C5 inhibition theoretically preserves C3 activity, it may offer additional safety advantages. A second confirmatory pivotal clinical trial is underway to confirm the efficacy and safety of avacincaptad pegol in slowing the GA growth (GATHER2 Study).",2020,"Further, there were no ocular serious adverse events and no cases of endophthalmitis.","['286 participants with GA secondary to AMD', 'participants with geographic atrophy (GA) secondary to AMD (GATHER1 Study', 'Geographic Atrophy Due to Age-Related Macular Degeneration']","['avacincaptad pegol (Zimura®', 'C5 Inhibitor Avacincaptad Pegol']","['mean rate of GA growth (square root transformation', 'GA growth', 'mean rate of change in GA over 12 months measured by fundus autofluorescence (FAF', 'endophthalmitis', 'tolerated']","[{'cui': 'C1536085', 'cui_str': 'Dry Macular Degeneration'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0024437', 'cui_str': 'Degenerative disorder of macula'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]","[{'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1536085', 'cui_str': 'Dry Macular Degeneration'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C3714584', 'cui_str': 'Transformation'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C4324299', 'cui_str': 'Fundus autofluorescence'}, {'cui': 'C0014236', 'cui_str': 'Endophthalmitis'}]",286.0,0.0820782,"Further, there were no ocular serious adverse events and no cases of endophthalmitis.","[{'ForeName': 'Glenn J', 'Initials': 'GJ', 'LastName': 'Jaffe', 'Affiliation': 'Department of Ophthalmology, Duke University, Durham, North Carolina.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Westby', 'Affiliation': 'IVERIC bio, Inc., New York, New York.'}, {'ForeName': 'Karl G', 'Initials': 'KG', 'LastName': 'Csaky', 'Affiliation': 'Retina Foundation of Southwest, Dallas, Texas.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Monés', 'Affiliation': 'Institut de la Màcula and Barcelona Macula Foundation, Barcelona, Spain.'}, {'ForeName': 'Joel A', 'Initials': 'JA', 'LastName': 'Pearlman', 'Affiliation': 'Vitreoretinal Medical Group, Inc., Sacramento, California.'}, {'ForeName': 'Sunil S', 'Initials': 'SS', 'LastName': 'Patel', 'Affiliation': 'West Texas Retina Consultants, Abilene, Texas.'}, {'ForeName': 'Brian C', 'Initials': 'BC', 'LastName': 'Joondeph', 'Affiliation': 'Colorado Retina, Denver, Colorado.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Randolph', 'Affiliation': 'Center for Retina and Macular Disease, Winter Haven, Florida.'}, {'ForeName': 'Harvey', 'Initials': 'H', 'LastName': 'Masonson', 'Affiliation': 'IVERIC bio, Inc., New York, New York.'}, {'ForeName': 'Kourous A', 'Initials': 'KA', 'LastName': 'Rezaei', 'Affiliation': 'IVERIC bio, Inc., New York, New York. Electronic address: karezaei@yahoo.com.'}]",Ophthalmology,['10.1016/j.ophtha.2020.08.027']
2620,32886811,Cystoscopy with antibiotic irrigation during pelvic reconstruction and minimally invasive gynecologic surgery: A double-blind randomized controlled trial.,"AIMS


After pelvic reconstructive surgery, the risk of postoperative urinary tract infection (UTI) is significant; intraoperative cystoscopy may contribute to this risk. Intravesical antibiotics are used in the ambulatory setting and may be applied to the surgical arena. Our objective was to evaluate the efficacy of antibiotic irrigation during intraoperative cystoscopy to prevent postoperative UTI.
METHODS


This double-blind randomized controlled trial enrolled 216 women undergoing cystoscopy with elective surgery for pelvic organ prolapse, stress urinary incontinence, or laparoscopic gynecologic surgery at an academic medical center 2016-2019. Participants were randomized to cystoscopic irrigation fluid type: normal saline (control) or 200,000 U polymyxin B + 40 mg neomycin solution in normal saline (antibiotic). Patients and providers who treated UTIs were blinded. The primary outcome was treatment of UTI within 6 weeks postoperatively, defined as positive culture or treatment for a symptomatic UTI. χ 2  and multivariable logistic regression analyses were performed.
RESULTS


We enrolled 216 women: 111 control (51.4%) and 105 antibiotic (48.6%). Mean age was 51.6 years. Groups were well matched in medical comorbidities and surgery type. Primary vaginal surgery was most common (n = 127, 58.8%). Overall, 10.7% of patients developed a postoperative UTI with no difference in incidence between groups: 9.9% of control (n = 11, 95% confidence interval [CI]: 4.0%-16.0%) versus 11.4% of antibiotic subjects (n = 12, 95% CI: 5.0%-18.0%), on χ 2  (p = .718) and logistic regression analysis (adjusted odds ratio, 1.3; CI: 0.53-3.16; p = .569).
CONCLUSION


When cystoscopy is performed during elective pelvic surgery, use of antibiotic irrigation does not impact the rate of postoperative UTI.",2020,"When cystoscopy is performed during elective pelvic surgery, use of antibiotic irrigation does not impact the rate of postoperative UTI.","['Patients and providers who treated UTIs were blinded', 'Mean age was 51.6 years', '216 women undergoing cystoscopy with elective surgery for pelvic organ prolapse, stress urinary incontinence, or laparoscopic gynecologic surgery at an academic medical center 2016-2019', 'We enrolled 216 women: 111 control (51.4%) and 105 antibiotic (48.6']","['cystoscopic irrigation fluid type: normal saline (control) or 200,000 U polymyxin B\u2009+\u200940 mg neomycin solution in normal saline (antibiotic', 'Intravesical antibiotics', 'pelvic reconstruction and minimally invasive gynecologic surgery', 'antibiotic irrigation', 'Cystoscopy with antibiotic irrigation']","['UTI within 6 weeks postoperatively, defined as positive culture or treatment for a symptomatic UTI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4708905', 'cui_str': '216'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0010702', 'cui_str': 'Cystoscopy'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0877015', 'cui_str': 'Urogenital prolapse'}, {'cui': 'C0042025', 'cui_str': 'Genuine stress incontinence'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0038902', 'cui_str': 'Operation on female genital organs'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}]","[{'cui': 'C0593225', 'cui_str': 'Solution for irrigation'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0032535', 'cui_str': 'Polymyxin B'}, {'cui': 'C0027603', 'cui_str': 'Neomycin'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0442124', 'cui_str': 'Intravesical approach'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0038902', 'cui_str': 'Operation on female genital organs'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0010702', 'cui_str': 'Cystoscopy'}]","[{'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}]",216.0,0.725078,"When cystoscopy is performed during elective pelvic surgery, use of antibiotic irrigation does not impact the rate of postoperative UTI.","[{'ForeName': 'Emily A', 'Initials': 'EA', 'LastName': 'Slopnick', 'Affiliation': 'Department of Obstetrics and Gynecology, MetroHealth Medical Center, Cleveland, Ohio, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Welles Henderson', 'Affiliation': 'Department of Obstetrics and Gynecology, MetroHealth Medical Center, Cleveland, Ohio, USA.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Chapman', 'Affiliation': 'Department of Obstetrics and Gynecology, MetroHealth Medical Center, Cleveland, Ohio, USA.'}, {'ForeName': 'David D', 'Initials': 'DD', 'LastName': 'Sheyn', 'Affiliation': 'Urology Institute, University Hospitals Cleveland Medical Center, Cleveland, Ohio, USA.'}, {'ForeName': 'Sherif A', 'Initials': 'SA', 'LastName': 'El-Nashar', 'Affiliation': 'Department of Obstetrics and Gynecology, University Hospitals Cleveland Medical Center, Cleveland, Ohio, USA.'}, {'ForeName': 'Andrey', 'Initials': 'A', 'LastName': 'Petrikovets', 'Affiliation': 'Department of Obstetrics and Gynecology, MetroHealth Medical Center, Cleveland, Ohio, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Pollard', 'Affiliation': 'Department of Obstetrics and Gynecology, MetroHealth Medical Center, Cleveland, Ohio, USA.'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Mangel', 'Affiliation': 'Department of Obstetrics and Gynecology, MetroHealth Medical Center, Cleveland, Ohio, USA.'}]",Neurourology and urodynamics,['10.1002/nau.24499']
2621,32886828,Effects of Wu Qin xi Qigong exercise on physical functioning in elderly people with knee osteoarthritis: A randomized controlled trial.,"AIM


Exercise therapy is a key intervention in the management of knee osteoarthritis (OA). This study aimed to test the 6-month effectiveness of Wu Qin Xi Qigong (WQXQ) exercise versus a conventional physical therapy (control group [CG]) on physical functioning in patients with early knee OA.
METHODS


This study was a 6-month follow-up from a randomized controlled trial. Participants with knee OA were randomly allocated to the WQXQ or CG. Data from the Berg Balance Scale, Timed Up and Go Test, 6-Minute Walk Test, 30-Second Chair Stand Test, the Western Ontario and McMaster Universities Osteoarthritis Index, knee extension strength and knee flexion strength were collected before and after the 6-month intervention.
RESULTS


Both treatment groups demonstrated large (20%-50%) and clinically relevant reductions in activity limitations, pain and knee instability, which were sustained at 6 months post-treatment. No differences in effectiveness between experimental and control treatment were found on Timed Up and Go Test, 6-Minute Walk Test, knee extension strength and knee flexion strength except for a higher Berg Balance Scale score (P = 0.029) and lower Western Ontario and McMaster Universities Osteoarthritis Index pain score (P = 0.031) in the WQXQ group.
CONCLUSIONS


Both WQXQ and conventional physical therapy exercise programs were highly effective in reducing activity limitations and pain, and promoting balance and muscle power. WQXQ was found to be more effective in promoting balance and reducing pain than conventional physical therapy exercise in patients with knee OA. Geriatr Gerontol Int 2020; 20: 899-903.",2020,"No differences in effectiveness between experimental and control treatment were found on Timed Up and Go Test, 6-Minute Walk Test, knee extension strength and knee flexion strength except for a higher Berg Balance Scale score (P = 0.029) and lower Western Ontario and McMaster Universities Osteoarthritis Index pain score (P = 0.031) in the WQXQ group.
","['patients with knee OA', 'patients with early knee OA', 'knee osteoarthritis (OA', 'elderly people with knee osteoarthritis', 'Participants with knee OA']","['WQXQ and conventional physical therapy exercise programs', 'conventional physical therapy exercise', 'WQXQ or CG', 'Wu Qin', 'Wu Qin Xi Qigong (WQXQ) exercise', 'conventional physical therapy (control group [CG', 'Qigong exercise', 'WQXQ', 'Exercise therapy']","['Berg Balance Scale, Timed Up and Go Test, 6-Minute Walk Test, 30-Second Chair Stand Test, the Western Ontario and McMaster Universities Osteoarthritis Index, knee extension strength and knee flexion strength', 'Timed Up and Go Test, 6-Minute Walk Test, knee extension strength and knee flexion strength except for a higher Berg Balance Scale score', 'activity limitations, pain and knee instability', 'lower Western Ontario and McMaster Universities Osteoarthritis Index pain score', 'activity limitations and pain, and promoting balance and muscle power', 'physical functioning', 'pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0282077', 'cui_str': 'Qigong'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0332300', 'cui_str': 'Except for'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0427262', 'cui_str': 'Unstable knee'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0427052', 'cui_str': 'Finding of power of skeletal muscle'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",,0.04281,"No differences in effectiveness between experimental and control treatment were found on Timed Up and Go Test, 6-Minute Walk Test, knee extension strength and knee flexion strength except for a higher Berg Balance Scale score (P = 0.029) and lower Western Ontario and McMaster Universities Osteoarthritis Index pain score (P = 0.031) in the WQXQ group.
","[{'ForeName': 'Chunmei', 'Initials': 'C', 'LastName': 'Xiao', 'Affiliation': 'Department of Health Promotion and Physical Education, Beijing Institute of Graphic Communication, Beijing, China.'}, {'ForeName': 'Yongchang', 'Initials': 'Y', 'LastName': 'Zhuang', 'Affiliation': 'Department of Wushu, Beijing Sport University, Beijing, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Kang', 'Affiliation': 'Department of Health Promotion and Physical Education, Beijing University of Chemical Technology, Beijing, China.'}]",Geriatrics & gerontology international,['10.1111/ggi.14007']
2622,32889912,Intensive statin versus low-dose statin + ezetimibe treatment for fibrous cap thickness of coronary vulnerable plaques.,"BACKGROUND


Acute coronary syndromes mainly result from abrupt thrombotic occlusion caused by atherosclerotic vulnerable plaques (VPs) that suddenly rupture or erosion. Fibrous cap thickness (FCT) is a major determinant of the propensity of a VP to rupture and is recognized as a key factor. The intensive use of statins is known to have the ability to increase FCT; however, there is a risk of additional adverse effects. However, lower dose statin with ezetimibe is known to be tolerable by patients. The present study aimed to investigate the effect of intensive statin vs. low-dose stain + ezetimibe therapy on FCT, as evaluated using optical coherence tomography.
METHOD


Patients who had VPs (minimum FCT <65 μm and lipid core >90°) and deferred from intervention in our single center from January 2014 to December 2018 were included in the trial. They were divided into the following two groups: intensive statin group (rosuvastatin 15-20 mg or atorvastatin 30-40 mg) and combination therapy group (rosuvastatin 5-10 mg or atorvastatin 10-20 mg + ezetimibe 10 mg). At the 12-month follow-up, we compared the change in the FCT (ΔFCT%) between the two groups and analyzed the association of ΔFCT% with risk factors. Fisher exact test was used for all categorical variables. Student's t test or Mann-Whitney U-test was used for analyzing the continuous data. The relationship between ΔFCT% and risk factors was analyzed using linear regression analysis.
RESULT


Total 53 patients were finally enrolled, including 26 patients who were in the intensive statin group and 27 who were in the combination therapy group. At the 12-month follow-up, the serum levels of total cholesterol (TC), total triglyceride, low-density lipoprotein (LDL-C), hypersensitive C-reactive protein (hs-CRP), and lipoprotein-associated phospholipase A2 (Lp-PLA2) levels were reduced in both the groups. The ΔTC%, ΔLDL-C%, and ΔLp-PLA2% were decreased further in the combination therapy group. FCT was increased in both the groups (combination treatment group vs. intensive statin group: 128.89 ± 7.64 vs. 110.19 ± 7.00 μm, t = -9.282, P < 0.001) at the 12-month follow-up. The increase in ΔFCT% was more in the combination therapy group (123.46% ± 14.05% vs. 91.14% ± 11.68%, t = -9.085, P < 0.001). Based on the multivariate linear regression analysis, only the serum Lp-PLA2 at the 12-month follow-up (B = -0.203, t = -2.701, P = 0.010), ΔTC% (B = -0.573, t = -2.048, P = 0.046), and Δhs-CRP% (B = -0.302, t = -2.963, P = 0.005) showed an independent association with ΔFCT%.
CONCLUSIONS


Low-dose statin combined with ezetimibe therapy maybe provide a profound and significant increase in FCT as compared to intensive statin monotherapy. The reductions in Lp-PLA2, ΔTC%, and Δhs-CRP% are independently associated with an increase in FCT.",2020,"The increase in ΔFCT% was more in the combination therapy group (123.46% ± 14.05% vs. 91.14% ± 11.68%, t = -9.085, P < 0.001).","['Patients who had VPs (minimum FCT', 'fibrous cap thickness of coronary vulnerable plaques', 'Total 53 patients were finally enrolled, including 26 patients who were in the intensive statin group and 27 who were in the combination therapy group', '90°) and deferred from intervention in our single center from January 2014 to December 2018 were included in the trial']","['intensive statin vs. low-dose stain + ezetimibe therapy', 'ezetimibe', 'Intensive statin versus low-dose statin + ezetimibe', 'Fibrous cap thickness (FCT', 'intensive statin group (rosuvastatin 15-20 mg or atorvastatin 30-40 mg) and combination therapy group (rosuvastatin 5-10 mg or atorvastatin 10-20 mg + ezetimibe']","['serum levels of total cholesterol (TC), total triglyceride, low-density lipoprotein (LDL-C), hypersensitive C-reactive protein (hs-CRP), and lipoprotein-associated phospholipase A2 (Lp-PLA2) levels', 'ΔFCT', 'FCT', 'Lp-PLA2, ΔTC%, and Δhs-CRP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0439709', 'cui_str': 'Fibrous'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0038128', 'cui_str': 'Stain'}, {'cui': 'C1142985', 'cui_str': 'ezetimibe'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439709', 'cui_str': 'Fibrous'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0965129', 'cui_str': 'rosuvastatin'}, {'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0023820', 'cui_str': 'Lipoprotein'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0031667', 'cui_str': 'Phospholipase A>2<'}, {'cui': 'C0439709', 'cui_str': 'Fibrous'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C1280412', 'cui_str': 'Thick'}]",53.0,0.0232764,"The increase in ΔFCT% was more in the combination therapy group (123.46% ± 14.05% vs. 91.14% ± 11.68%, t = -9.085, P < 0.001).","[{'ForeName': 'Pei-Na', 'Initials': 'PN', 'LastName': 'Meng', 'Affiliation': 'Department of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, Jiangsu 210006, China.'}, {'ForeName': 'De-Lu', 'Initials': 'DL', 'LastName': 'Yin', 'Affiliation': ""Department of Cardiology, The First People's Hospital of Lianyungang, Lianyungang, Jiangsu 222000, China.""}, {'ForeName': 'Wen-Qi', 'Initials': 'WQ', 'LastName': 'Lu', 'Affiliation': 'Department of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, Jiangsu 210006, China.'}, {'ForeName': 'Tian', 'Initials': 'T', 'LastName': 'Xu', 'Affiliation': 'Department of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, Jiangsu 210006, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'You', 'Affiliation': 'Department of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, Jiangsu 210006, China.'}, {'ForeName': 'Zhi-Ming', 'Initials': 'ZM', 'LastName': 'Wu', 'Affiliation': 'Department of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, Jiangsu 210006, China.'}, {'ForeName': 'Xiang-Qi', 'Initials': 'XQ', 'LastName': 'Wu', 'Affiliation': 'Department of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, Jiangsu 210006, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Ye', 'Affiliation': 'Department of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, Jiangsu 210006, China.'}]",Chinese medical journal,['10.1097/CM9.0000000000001067']
2623,32896644,Transcranial direct current stimulation: A novel approach in the treatment of vascular depression.,"BACKGROUND


Despite the impact of depression in terms of personal suffering and socioeconomic burden, most currently available treatment options are often ineffective. A particularly difficult-to-treat depressive disorder characteristic of the elderly is vascular depression, a late-life depressive syndrome related to a variety of potential vascular mechanisms. Transcranial Direct Current Stimulation (tDCS), a non-invasive and effective somatic approach to depression, also showed positive effects on cognitive deficits.
AIM


We performed a double-blind randomized study to investigate the efficacy of tDCS as augmentation strategy to sertraline in the treatment of vascular depression, hypothesizing a positive effect in both depressive symptoms and cognitive functions.
METHODS


We enrolled 93 inpatients over 60 years of age with a diagnosis of vascular depression. Depressive symptoms were weekly assessed (T0, T1, T2) with the 21-items Hamilton depression rating scale (HDRS). Cognitive functioning was evaluated with the Milan Overall Dementia Assessment (MODA) at baseline and after the treatment protocol. All patients were randomly assigned into three groups, Group I: one tDCS stimulation per day, Group II: two tDCS stimulations per day, Sham group: one sham tDCS stimulation per day. Stimulation was performed for 10 consecutive working days.
RESULTS


A significant interaction time∗treatment was observed on HDRS scores (F = 14, p < 0.001). All groups improved at T1 but whereas Group II significantly differed from the Sham group (p < 0.001) we observed no difference between Sham and Group I. At T2 all groups improved but Group II showed the greater improvement (vs. Sham p < 0.001; vs. Group I p < 0.001) and the Sham group the smallest (vs. Group I p = 0.005). A significant interaction time∗treatment was also observed on MODA scores (F = 3.31, p = 0.04). Only subjects treated with tDCS improved at T2 (Group I: p < 0.001; Group II: p = 0.007). However, no difference between Group I and II was shown.
CONCLUSION


tDCS as augmentation treatment of an adequate pharmacotherapy is a potential strategy in the management of vascular depression, a disease known to be often unresponsive to antidepressants only. Non-invasiveness, the absence of severe side effects and the possibility of administering it to outpatients at an affordable price make tDCS an important tool in clinical practice.",2020,At T2 all groups improved but Group II showed the greater improvement (vs. Sham p<0.001;,['93 inpatients over 60 years of age with a diagnosis of vascular depression'],"['sertraline', 'tDCS stimulation per day, Group II: two tDCS stimulations per day, Sham group: one sham tDCS stimulation per day', 'Transcranial Direct Current Stimulation (tDCS', 'Transcranial direct current stimulation', 'tDCS']","['MODA scores', 'Depressive symptoms', '21-items Hamilton depression rating scale (HDRS', 'HDRS scores']","[{'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",93.0,0.13066,At T2 all groups improved but Group II showed the greater improvement (vs. Sham p<0.001;,"[{'ForeName': 'Raffaella', 'Initials': 'R', 'LastName': 'Zanardi', 'Affiliation': 'IRCCS San Raffaele Scientific Institute, Department of Clinical Neurosciences, Mood Disorder Unit, Milan, Italy; University Vita-Salute San Raffaele, Department of Clinical Neurosciences, Milan, Italy. Electronic address: zanardi.raffaella@hsr.it.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Poletti', 'Affiliation': 'University Vita-Salute San Raffaele, Department of Clinical Neurosciences, Milan, Italy.'}, {'ForeName': 'Dario', 'Initials': 'D', 'LastName': 'Prestifilippo', 'Affiliation': 'University Vita-Salute San Raffaele, Department of Clinical Neurosciences, Milan, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Attanasio', 'Affiliation': 'University Vita-Salute San Raffaele, Department of Clinical Neurosciences, Milan, Italy.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Barbini', 'Affiliation': 'IRCCS San Raffaele Scientific Institute, Department of Clinical Neurosciences, Mood Disorder Unit, Milan, Italy; University Vita-Salute San Raffaele, Department of Clinical Neurosciences, Milan, Italy.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Colombo', 'Affiliation': 'IRCCS San Raffaele Scientific Institute, Department of Clinical Neurosciences, Mood Disorder Unit, Milan, Italy; University Vita-Salute San Raffaele, Department of Clinical Neurosciences, Milan, Italy.'}]",Brain stimulation,['10.1016/j.brs.2020.08.013']
2624,32896692,Validation of the Musculoskeletal Health Questionnaire (MSK-HQ) in primary care patients with musculoskeletal pain.,"OBJECTIVE


To evaluate the responsiveness, and concurrent validity of the Musculoskeletal Health Questionnaire (MSK-HQ) in UK primary care patients with common musculoskeletal (MSK) pain presentations.
METHODS


A secondary analysis of a primary care pilot randomised trial (STarT MSK) was performed. In 524 people consulting with back, neck, shoulder, knee, or multi-site pain, the following were recorded at 0/6 months: MSK-HQ, EQ-5D-5L, Roland-Morris Disability Questionnaire (RMDQ; back pain), Neck Disability Index (NDI), Shoulder Pain and Disability Index (SPADI), Knee Injury and Outcome Score (KOOS), Short-Form-12 (SF-12; multisite pain). At 6-months, patients self-rated their global change in MSK condition, from -5 (""very much worse"") to +5 (""completely recovered""). Receiver operating characteristic curves evaluated abilities of 6-month changes in each patient reported outcome measure (PROM) to discriminate between patients improving/not improving on global change scores, with Minimal Clinically Important Differences (MCID) calculated.
RESULTS


The MSK-HQ had a good ability to discriminate between MSK pain patients reporting global improvement vs. no improvement (area under the curve [AUC] 0.81; 95% CI 0.78, 0.85). Its discriminative ability was higher than the EQ-5D-5L (AUC 0.68; 95% CI 0.62, 0.73) and similar to site-specific PROMs. The MCID for the 6-month change in MSK-HQ was 5.5. The MSK-HQ had strong correlations with all PROMs, except SF-12 scores.
CONCLUSION


In primary care patients with common MSK pain presentations, the MSK-HQ was as good as existing pain-site specific PROMs at identifying people reporting global improvements in their MSK condition, and was better than the EQ-5D-5L.",2020,"Its discriminative ability was higher than the EQ-5D-5L (AUC 0.68; 95% CI 0.62, 0.73) and similar to site-specific PROMs.","['524 people consulting with back, neck, shoulder, knee, or multi-site pain, the following were recorded at 0/6 months', 'primary care patients with musculoskeletal pain', 'primary care patients with common MSK pain presentations', 'UK primary care patients with common musculoskeletal (MSK) pain presentations']","['Musculoskeletal Health Questionnaire (MSK-HQ', 'EQ-5D-5L']","['global change scores', 'MSK-HQ, EQ-5D-5L, Roland-Morris Disability Questionnaire (RMDQ; back pain), Neck Disability Index (NDI), Shoulder Pain and Disability Index (SPADI), Knee Injury and Outcome Score (KOOS), Short-Form-12 (SF-12; multisite pain']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026858', 'cui_str': 'Musculoskeletal pain'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0022744', 'cui_str': 'Injury of knee'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.135736,"Its discriminative ability was higher than the EQ-5D-5L (AUC 0.68; 95% CI 0.62, 0.73) and similar to site-specific PROMs.","[{'ForeName': 'Dr Ian C', 'Initials': 'DIC', 'LastName': 'Scott', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Keele, UK; Clinical Trials Unit, School of Primary, Community and Social Care, Keele University, Keele, UK; Haywood Academic Rheumatology Centre, Haywood Hospital, Midlands Partnership NHS Foundation Trust, High Lane, Burslem, Staffordshire, UK. Electronic address: i.scott@keele.ac.uk.'}, {'ForeName': 'Dr Gareth', 'Initials': 'DG', 'LastName': 'McCray', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Keele, UK.'}, {'ForeName': 'Prof Gillian', 'Initials': 'PG', 'LastName': 'Lancaster', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Keele, UK; Clinical Trials Unit, School of Primary, Community and Social Care, Keele University, Keele, UK.'}, {'ForeName': 'Prof Nadine E', 'Initials': 'PNE', 'LastName': 'Foster', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Keele, UK.'}, {'ForeName': 'Dr Jonathan C', 'Initials': 'DJC', 'LastName': 'Hill', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Keele, UK.'}]",Seminars in arthritis and rheumatism,['10.1016/j.semarthrit.2020.06.022']
2625,32894793,A multicenter prospective study for overactive bladder patient treatment satisfaction with mirabegron after being unsatisfied with antimuscarinic therapy (FAVOR study).,"AIM


We investigated the satisfaction and efficacy of mirabegron in patients with overactive bladder (OAB) symptoms who were unsatisfied with previous antimuscarinic treatment.
METHODS


This was a 12-week, open-label study of adults with OAB who had been treated with antimuscarinics within 2 years of screening and expressed dissatisfaction over poor efficacy or adverse events of antimuscarinics. All enrolled patients have received mirabegron 50 mg once daily for 12 weeks. The primary outcome was the percentage of patients reporting treatment satisfaction questions (TSQ) at week 12 (""very satisfied"" or ""somewhat satisfied""). Patients completed voiding diaries, Overactive Bladder Questionnaire short form (OAB-q-SF), Overactive Bladder Symptom Score (OABSS), and the global response assessment (GRA) at baseline, Week 4, and Week 12. At 12-weeks, patients were assessed for willingness to continue treatment.
RESULTS


The response rate of treatment satisfaction at 12 weeks was 69.3% (275/397) (95% confidence interval 64.7-73.8). Significant improvements from baseline to weeks 4 and 12 were observed in the frequency, urgency due to urinary incontinence, and urgency episodes per 24 h (all p < .0001). Both OAB-q-SF and OABSS were significantly improved compared to baseline. At 4 and 12 weeks, 27.5% and 41.8% of patients, respectively, responded to the GRA as being moderately or markedly improved. At 12 weeks, 80.8% of patients were willing to continue mirabegron.
CONCLUSIONS


Mirabegron improved the rates of treatment satisfaction and symptoms in patients with OAB who were unsatisfied with prior antimuscarinic treatment.",2020,"Significant improvements from baseline to weeks 4 and 12 were observed in the frequency, urgency due to urinary incontinence, and urgency episodes per 24 h (all p < .0001).","['patients with overactive bladder (OAB) symptoms who were unsatisfied with previous antimuscarinic treatment', 'adults with OAB who had been treated with antimuscarinics within 2 years of screening and expressed dissatisfaction over poor efficacy or adverse events of antimuscarinics', 'patients with OAB who were unsatisfied with prior antimuscarinic treatment', 'overactive bladder patient treatment satisfaction with mirabegron after being unsatisfied with antimuscarinic therapy\xa0(FAVOR study']",['mirabegron'],"['rates of treatment satisfaction and symptoms', 'response rate of treatment satisfaction', 'OAB-q-SF and OABSS', 'voiding diaries, Overactive Bladder Questionnaire short form (OAB-q-SF), Overactive Bladder Symptom Score (OABSS), and the global response assessment (GRA', 'frequency, urgency due to urinary incontinence, and urgency episodes', 'percentage of patients reporting treatment satisfaction questions (TSQ', 'satisfaction and efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0003385', 'cui_str': 'Muscarinic receptor antagonist'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C2983812', 'cui_str': 'mirabegron'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C2983812', 'cui_str': 'mirabegron'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.0680329,"Significant improvements from baseline to weeks 4 and 12 were observed in the frequency, urgency due to urinary incontinence, and urgency episodes per 24 h (all p < .0001).","[{'ForeName': 'Kwang Jin', 'Initials': 'KJ', 'LastName': 'Ko', 'Affiliation': 'Department of Urology,\xa0Kangnam Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Myung-Soo', 'Initials': 'MS', 'LastName': 'Choo', 'Affiliation': 'Department of Urology,\xa0Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Young-Seop', 'Initials': 'YS', 'LastName': 'Chang', 'Affiliation': 'Department of Urology, Konyang University College of Medicine, Daejeon, Korea.'}, {'ForeName': 'Joon Chul', 'Initials': 'JC', 'LastName': 'Kim', 'Affiliation': 'Department of Urology I College of Medicine, The Catholic University of Korea, Seoul, Korea.'}, {'ForeName': 'Kyu-Sung', 'Initials': 'KS', 'LastName': 'Lee', 'Affiliation': 'Department of Urology,\xa0Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}]",Neurourology and urodynamics,['10.1002/nau.24505']
2626,32899289,Caloric and Macronutrient Intake and Meal Timing Responses to Repeated Sleep Restriction Exposures Separated by Varying Intervening Recovery Nights in Healthy Adults.,"Sleep restriction (SR) reliably increases caloric intake. It remains unknown whether such intake cumulatively increases with repeated SR exposures and is impacted by the number of intervening recovery sleep opportunities. Healthy adults (33.9 ± 8.9y; 17 women, Body Mass Index: 24.8 ± 3.6) participated in a laboratory protocol. N = 35 participants experienced two baseline nights (10 h time-in-bed (TIB)/night; 22:00-08:00) followed by 10 SR nights (4 h TIB/night; 04:00-08:00), which were divided into two exposures of five nights each and separated by one (n = 13), three (n = 12), or five (n = 10) recovery nights (12 h TIB/night; 22:00-10:00). Control participants (n = 10) were permitted 10 h TIB (22:00-08:00) on all nights. Food and drink consumption were ad libitum and recorded daily. Compared to baseline, sleep-restricted participants increased daily caloric (+527 kcal) and saturated fat (+7 g) intake and decreased protein (-1.2% kcal) intake during both SR exposures; however, intake did not differ between exposures or recovery conditions. Similarly, although sleep-restricted participants exhibited substantial late-night caloric intake (671 kcal), such intake did not differ between exposures or recovery conditions. By contrast, control participants showed no changes in caloric intake across days. We found consistent caloric and macronutrient intake increases during two SR exposures despite varying intervening recovery nights. Thus, energy intake outcomes do not cumulatively increase with repeated restriction and are unaffected by recovery opportunities.",2020,"Compared to baseline, sleep-restricted participants increased daily caloric (+527 kcal) and saturated fat (+7 g) intake and decreased protein (-1.2% kcal) intake during both SR exposures; however, intake did not differ between exposures or recovery conditions.","['Healthy Adults', 'Healthy adults (33.9 ± 8.9y; 17 women, Body Mass Index: 24.8 ± 3.6) participated in a laboratory protocol']",['Sleep restriction (SR'],"['daily caloric (+527 kcal) and saturated fat (+7 g) intake and decreased protein', 'caloric intake', 'substantial late-night caloric intake']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C4517718', 'cui_str': '33.9'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517694', 'cui_str': '3.6'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4517805', 'cui_str': '527'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0597423', 'cui_str': 'Saturated fat'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0240526', 'cui_str': 'Night time'}]",10.0,0.0223244,"Compared to baseline, sleep-restricted participants increased daily caloric (+527 kcal) and saturated fat (+7 g) intake and decreased protein (-1.2% kcal) intake during both SR exposures; however, intake did not differ between exposures or recovery conditions.","[{'ForeName': 'Andrea M', 'Initials': 'AM', 'LastName': 'Spaeth', 'Affiliation': 'Department of Kinesiology and Health, Division of Life Sciences, School of Arts and Sciences, Rutgers University, New Brunswick, NJ 08901, USA.'}, {'ForeName': 'Namni', 'Initials': 'N', 'LastName': 'Goel', 'Affiliation': 'Biological Rhythms Research Laboratory, Department of Psychiatry and Behavioral Sciences, Rush University Medical Center, Chicago, IL 60612, USA.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Dinges', 'Affiliation': 'Unit for Experimental Psychiatry, Division of Sleep and Chronobiology, Department of Psychiatry, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA 19104, USA.'}]",Nutrients,['10.3390/nu12092694']
2627,32899447,Exercise Training and Vitamin C Supplementation Affects Ferritin mRNA in Leukocytes without Affecting Prooxidative/Antioxidative Balance in Elderly Women.,"Physical training and antioxidant supplementation may influence iron metabolism through reduced oxidative stress and subsequent lowering of mRNA levels of genes that are easily induced by this stress, including those responsible for iron homeostasis. Fifteen elderly women participated in our 12-week experiment, involving six weeks of training without supplementation and six weeks of training supported by oral supplementation of 1000 mg of vitamin C daily. The participants were divided into two groups ( n  = 7 in group 1 and  n  = 8 in group 2). In group 1, we applied vitamin C supplementation in the first six weeks of training, while in group 2 during the remaining six weeks of training. In both phases, the health-related training occurred three times per week. Training accompanied by vitamin C supplementation did not affect prooxidative/antioxidative balance but significantly decreased ferritin heavy chain  (FTH ) and ferritin light chain ( FTL ) mRNA in leukocytes (for  FTH  mRNA from 2^64.24 to 2^11.06,  p  = 0.03 in group 1 and from 2^60.54 to 2^16.03,  p  = 0.01 in group 2, for  FTL  mRNA from 2^20.22 to 2^4.53,  p  = 0.01 in group 2). We concluded that vitamin C supplementation might have caused a decrease in gene expression of two important antioxidative genes ( FTH, FTL)  and had no effect on plasma prooxidative/antioxidative balance.",2020,"Training accompanied by vitamin C supplementation did not affect prooxidative/antioxidative balance but significantly decreased ferritin heavy chain  (FTH ) and ferritin light chain ( FTL ) mRNA in leukocytes (for  FTH  mRNA from 2^64.24 to 2^11.06,  ","['Fifteen elderly women', 'Elderly Women']","['vitamin C supplementation', 'training without supplementation and six weeks of training supported by oral supplementation of 1000 mg of vitamin C daily', 'Exercise Training and Vitamin C Supplementation', 'Physical training and antioxidant supplementation']","['ferritin heavy chain  (FTH ) and ferritin light chain ( FTL ) mRNA in leukocytes', 'prooxidative/antioxidative balance', 'plasma prooxidative/antioxidative balance']","[{'cui': 'C0524338', 'cui_str': 'Elderly woman'}]","[{'cui': 'C4524018', 'cui_str': 'Vitamin C supplementation'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0040608', 'cui_str': 'Training Support'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}]","[{'cui': 'C0162905', 'cui_str': 'H-Ferritin'}, {'cui': 'C1855305', 'cui_str': 'Frank-Ter Haar syndrome'}, {'cui': 'C0391764', 'cui_str': 'L-Ferritin'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}]",15.0,0.0181971,"Training accompanied by vitamin C supplementation did not affect prooxidative/antioxidative balance but significantly decreased ferritin heavy chain  (FTH ) and ferritin light chain ( FTL ) mRNA in leukocytes (for  FTH  mRNA from 2^64.24 to 2^11.06,  ","[{'ForeName': 'Małgorzata', 'Initials': 'M', 'LastName': 'Żychowska', 'Affiliation': 'Department of Sport, Faculty of Physical Education, Kazimierz Wielki University in Bydgoszcz, 85-064 Bydgoszcz, Poland.'}, {'ForeName': 'Agata', 'Initials': 'A', 'LastName': 'Grzybkowska', 'Affiliation': 'Department of Biochemistry, Faculty of Physical Education, Gdansk University of Physical Education and Sport, 80-336 Gdansk, Poland.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Wiech', 'Affiliation': 'Department of Health Promotion, Faculty of Tourism and Recreation, Gdansk University of Physical Education and Sport, 80-336 Gdansk, Poland.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Urbański', 'Affiliation': 'Department of Biomechanics and Sports Engineering, Faculty of Physical Education, Gdansk University of Physical Education and Sport, 80-336 Gdansk, Poland.'}, {'ForeName': 'Wanda', 'Initials': 'W', 'LastName': 'Pilch', 'Affiliation': 'Department of Cosmetology, Faculty of Physiotherapy, University of Physical Education in Krakow, 31-571 Krakow, Poland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Piotrowska', 'Affiliation': 'Department of Cosmetology, Faculty of Physiotherapy, University of Physical Education in Krakow, 31-571 Krakow, Poland.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Czerwińska-Ledwig', 'Affiliation': 'Department of Cosmetology, Faculty of Physiotherapy, University of Physical Education in Krakow, 31-571 Krakow, Poland.'}, {'ForeName': 'Jędrzej', 'Initials': 'J', 'LastName': 'Antosiewicz', 'Affiliation': 'Department of Bioenergetics and Exercise Physiology, Faculty of Health, Medical University of Gdansk, 80-210 Gdansk, Poland.'}]",International journal of molecular sciences,['10.3390/ijms21186469']
2628,32900785,"Effects of DPP-4 Inhibitor Linagliptin Versus Sulfonylurea Glimepiride as Add-on to Metformin on Renal Physiology in Overweight Patients With Type 2 Diabetes (RENALIS): A Randomized, Double-Blind Trial.","OBJECTIVE


To compare effects of the dipeptidyl peptidase 4 (DPP-4) inhibitor linagliptin with those of a sulfonylurea on renal physiology in metformin-treated patients with type 2 diabetes mellitus (T2DM).
RESEARCH DESIGN AND METHODS


In this double-blind randomized trial, 46 overweight T2DM patients without renal impairment received once-daily linagliptin (5 mg) or glimepiride (1 mg) for 8 weeks. Fasting glomerular filtration rate (GFR) and effective renal plasma flow (ERPF) were determined by inulin and para-aminohippuric acid clearances. Fractional excretions, urinary damage markers, and circulating DPP-4 substrates (among others, glucagon-like peptide 1 and stromal cell-derived factor-1α [SDF-1α]) were measured.
RESULTS


HbA 1c  reductions were similar with linagliptin (-0.45 ± 0.09%) and glimepiride (-0.65 ± 0.10%) after 8 weeks ( P  = 0.101). Linagliptin versus glimepiride did not affect GFR, ERPF, estimated intrarenal hemodynamics, or damage markers. Only linagliptin increased fractional excretion (FE) of sodium (FE Na ) and potassium, without affecting FE of lithium. Linagliptin-induced change in FE Na  correlated with SDF-1α ( R  = 0.660) but not with other DPP-4 substrates.
CONCLUSIONS


Linagliptin does not affect fasting renal hemodynamics compared with glimepiride in T2DM patients. DPP-4 inhibition promotes modest natriuresis, possibly mediated by SDF-1α, likely distal to the macula densa.",2020,"Linagliptin versus glimepiride did not affect GFR, ERPF, estimated intrarenal hemodynamics or damage-makers.","['metformin-treated patients with type 2 diabetes mellitus (T2DM', 'With Type 2 Diabetes (RENALIS', 'Overweight Patients', 'T2DM patients', '46 overweight T2DM patients without renal impairment received once']","['daily linagliptin', 'glimepiride', 'Linagliptin', 'linagliptin', 'sulfonylurea', 'dipeptidyl peptidase 4 (DPP-4) inhibitor linagliptin', 'DPP-4 Inhibitor Linagliptin Versus Sulfonylurea Glimepiride', 'Metformin']","['fractional excretion (FE) of sodium (FE Na ) and potassium FE K', 'Fasting glomerular filtration rate (GFR) and effective renal plasma flow (ERPF', 'renal physiology', 'Fractional excretions, urinary damage markers, and circulating DPP-4 substrates (among others, glucagon-like peptide 1 and stromal cell-derived factor-1α (SDF-1α', 'GFR, ERPF, estimated intrarenal hemodynamics or damage-makers', 'fasting renal hemodynamics', 'Renal Physiology']","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2746078', 'cui_str': 'Linagliptin'}, {'cui': 'C0061323', 'cui_str': 'glimepiride'}, {'cui': 'C0038766', 'cui_str': 'Sulfonylurea'}, {'cui': 'C0081937', 'cui_str': 'Dipeptidyl peptidase IV'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1827106', 'cui_str': 'Dipeptidyl peptidase IV inhibitor'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0428601', 'cui_str': 'Measurement of fractional excretion of sodium'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0206088', 'cui_str': 'Effective renal plasma flow'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0031842', 'cui_str': 'Physiology'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0081937', 'cui_str': 'Dipeptidyl peptidase IV'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0162597', 'cui_str': 'Stromal Cells'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0554244', 'cui_str': 'Maker'}]",46.0,0.155817,"Linagliptin versus glimepiride did not affect GFR, ERPF, estimated intrarenal hemodynamics or damage-makers.","[{'ForeName': 'Marcel H A', 'Initials': 'MHA', 'LastName': 'Muskiet', 'Affiliation': 'Diabetes Center, Amsterdam University Medical Centers, location VUmc, Amsterdam, the Netherlands ma.muskiet@amsterdamumc.nl.'}, {'ForeName': 'Lennart', 'Initials': 'L', 'LastName': 'Tonneijck', 'Affiliation': 'Diabetes Center, Amsterdam University Medical Centers, location VUmc, Amsterdam, the Netherlands.'}, {'ForeName': 'Mark M', 'Initials': 'MM', 'LastName': 'Smits', 'Affiliation': 'Diabetes Center, Amsterdam University Medical Centers, location VUmc, Amsterdam, the Netherlands.'}, {'ForeName': 'Mark H H', 'Initials': 'MHH', 'LastName': 'Kramer', 'Affiliation': 'Diabetes Center, Amsterdam University Medical Centers, location VUmc, Amsterdam, the Netherlands.'}, {'ForeName': 'D Margriet', 'Initials': 'DM', 'LastName': 'Ouwens', 'Affiliation': 'Institute of Clinical Biochemistry and Pathobiochemistry, German Diabetes Center, Düsseldorf, Germany.'}, {'ForeName': 'Bolette', 'Initials': 'B', 'LastName': 'Hartmann', 'Affiliation': 'Department of Biomedical Sciences, Panum Institute, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jens J', 'Initials': 'JJ', 'LastName': 'Holst', 'Affiliation': 'Department of Biomedical Sciences, Panum Institute, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Daan J', 'Initials': 'DJ', 'LastName': 'Touw', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'A H Jan', 'Initials': 'AHJ', 'LastName': 'Danser', 'Affiliation': 'Department of Internal Medicine, Erasmus University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Jaap A', 'Initials': 'JA', 'LastName': 'Joles', 'Affiliation': 'Department of Nephrology and Hypertension, University Medical Center, Utrecht, the Netherlands.'}, {'ForeName': 'Daniël H', 'Initials': 'DH', 'LastName': 'van Raalte', 'Affiliation': 'Diabetes Center, Amsterdam University Medical Centers, location VUmc, Amsterdam, the Netherlands.'}]",Diabetes care,['10.2337/dc20-0902']
2629,32902561,"Perioperative Open-lung Approach, Regional Ventilation, and Lung Injury in Cardiac Surgery.","BACKGROUND


In the Protective Ventilation in Cardiac Surgery (PROVECS) randomized, controlled trial, an open-lung ventilation strategy did not improve postoperative respiratory outcomes after on-pump cardiac surgery. In this prespecified subanalysis, the authors aimed to assess the regional distribution of ventilation and plasma biomarkers of lung epithelial and endothelial injury produced by that strategy.
METHODS


Perioperative open-lung ventilation consisted of recruitment maneuvers, positive end-expiratory pressure (PEEP) = 8 cm H2O, and low-tidal volume ventilation including during cardiopulmonary bypass. Control ventilation strategy was a low-PEEP (2 cm H2O) low-tidal volume approach. Electrical impedance tomography was used serially throughout the perioperative period (n = 56) to compute the dorsal fraction of ventilation (defined as the ratio of dorsal tidal impedance variation to global tidal impedance variation). Lung injury was assessed serially using biomarkers of epithelial (soluble form of the receptor for advanced glycation end-products, sRAGE) and endothelial (angiopoietin-2) lung injury (n = 30).
RESULTS


Eighty-six patients (age = 64 ± 12 yr; EuroSCORE II = 1.65 ± 1.57%) undergoing elective on-pump cardiac surgery were studied. Induction of general anesthesia was associated with ventral redistribution of tidal volumes and higher dorsal fraction of ventilation in the open-lung than the control strategy (0.38 ± 0.07 vs. 0.30 ± 0.10; P = 0.004). No effect of the open-lung strategy on the dorsal fraction of ventilation was noted at the end of surgery after median sternotomy closure (open-lung = 0.37 ± 0.09 vs. control = 0.34 ± 0.11; P = 0.743) or in extubated patients at postoperative day 2 (open-lung = 0.63 ± 0.18 vs. control = 0.59 ± 0.11; P > 0.999). Open-lung ventilation was associated with increased intraoperative plasma sRAGE (7,677 ± 3,097 pg/ml vs. 6,125 ± 1,400 pg/ml; P = 0.037) and had no effect on angiopoietin-2 (P > 0.999).
CONCLUSIONS


In cardiac surgery patients, open-lung ventilation provided larger dorsal lung ventilation early during surgery without a maintained benefit as compared with controls at the end of surgery and postoperative day 2 and was associated with higher intraoperative plasma concentration of sRAGE suggesting lung overdistension.
EDITOR’S PERSPECTIVE


",2020,No effect of the open-lung strategy on the dorsal fraction of ventilation was noted at the end of surgery after median sternotomy closure (open-lung = 0.37 ± 0.09 vs. control = 0.34 ± 0.11; P = 0.743) or in extubated patients at postoperative day 2 (open-lung = 0.63 ± 0.18 vs. control = 0.59 ± 0.11; P > 0.999).,"['cardiac surgery patients', 'Eighty-six patients (age = 64 ± 12 yr; EuroSCORE II = 1.65 ± 1.57%) undergoing elective on-pump cardiac surgery']","['open-lung ventilation', 'lung ventilation consisted of recruitment maneuvers, positive end-expiratory pressure (PEEP) = 8 cm H2O, and low-tidal volume ventilation including during cardiopulmonary bypass']","['postoperative respiratory outcomes', 'dorsal lung ventilation', 'dorsal fraction of ventilation', 'intraoperative plasma sRAGE', 'ventral redistribution of tidal volumes and higher dorsal fraction of ventilation']","[{'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3164744', 'cui_str': 'European system for cardiac operative risk evaluation'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0182537', 'cui_str': 'Pump'}]","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0554804', 'cui_str': 'Assisted breathing'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C0439476', 'cui_str': 'cmH2O'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0554804', 'cui_str': 'Assisted breathing'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C1704448', 'cui_str': 'Ventral'}, {'cui': 'C0332620', 'cui_str': 'Redistribution'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C0205250', 'cui_str': 'High'}]",,0.0821825,No effect of the open-lung strategy on the dorsal fraction of ventilation was noted at the end of surgery after median sternotomy closure (open-lung = 0.37 ± 0.09 vs. control = 0.34 ± 0.11; P = 0.743) or in extubated patients at postoperative day 2 (open-lung = 0.63 ± 0.18 vs. control = 0.59 ± 0.11; P > 0.999).,"[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Lagier', 'Affiliation': ''}, {'ForeName': 'Lionel J', 'Initials': 'LJ', 'LastName': 'Velly', 'Affiliation': ''}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Guinard', 'Affiliation': ''}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Bruder', 'Affiliation': ''}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Guidon', 'Affiliation': ''}, {'ForeName': 'Marcos F', 'Initials': 'MF', 'LastName': 'Vidal Melo', 'Affiliation': ''}, {'ForeName': 'Marie-Christine', 'Initials': 'MC', 'LastName': 'Alessi', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003539']
2630,32914866,Pembrolizumab plus chemotherapy versus chemotherapy alone in patients with advanced non-small cell lung cancer without tumor PD-L1 expression: A pooled analysis of 3 randomized controlled trials.,"BACKGROUND


Pembrolizumab plus platinum-based chemotherapy has demonstrated improved clinical outcomes over chemotherapy alone in patients with previously untreated advanced/metastatic non-small cell lung cancer (NSCLC), regardless of tumor programmed death ligand 1 (PD-L1) expression. This study pooled data from 3 randomized controlled trials to evaluate outcomes with pembrolizumab plus chemotherapy versus chemotherapy alone in patients with advanced/metastatic NSCLC negative for PD-L1 (ie, a tumor proportion score < 1%).
METHODS


Individual patient data were pooled from KEYNOTE-021 cohort G (nonsquamous; NCT02039674), KEYNOTE-189 (nonsquamous; NCT02578680 and NCT03950674), and KEYNOTE-407 (squamous; NCT02775435). Treatment comprised pembrolizumab plus chemotherapy (pemetrexed and platinum for nonsquamous histology and carboplatin and paclitaxel/nab-paclitaxel for squamous histology) or chemotherapy alone. Responses were assessed according to Response Evaluation Criteria in Solid Tumors version 1.1 by blinded, independent, central review. No α was assigned to this descriptive, exploratory analysis.
RESULTS


Four hundred forty-four of the 1328 patients (33.4%) who were enrolled across the 3 trials had PD-L1-negative tumors (256 on pembrolizumab plus chemotherapy [nonsquamous, n = 155; squamous, n = 94; other, n = 7] and 188 on chemotherapy alone [nonsquamous, n = 83; squamous, n = 99; other, n = 6]). The median time from randomization to the data cutoff was 28.0 months (range, 14.7-55.4 months). Pembrolizumab plus chemotherapy improved overall survival (OS; hazard ratio [HR], 0.63; 95% CI, 0.50-0.79) and progression-free survival (HR, 0.68; 95% CI, 0.56-0.83) over chemotherapy. Sixteen patients in the pembrolizumab plus chemotherapy arm completed 2 years of treatment; the objective response rate was 87.5% (95% CI, 61.7%-98.4%), and the 3-year OS rate was 100%. Adverse events (AEs) were experienced by 99.2% of the patients who received pembrolizumab plus chemotherapy and by 98.9% of the patients who received chemotherapy alone, with grade 3 or higher AEs occurring in 71.4% and 72.0%, respectively; immune-mediated AEs and infusion reactions were experienced by 29.0% and 12.4%, respectively.
CONCLUSIONS


Pembrolizumab plus chemotherapy demonstrated response and survival improvements with manageable safety in comparison with chemotherapy alone in PD-L1-negative advanced/metastatic NSCLC, and it is a standard-of-care first-line therapy for patients with advanced NSCLC, regardless of PD-L1 expression.
LAY SUMMARY


Some tumors produce a protein called programmed death ligand 1 (PD-L1), which interacts with the body's immune system and prevents an immune response against cancer. Antibody therapies such as pembrolizumab block interactions between tumor PD-L1 and the immune system and enable an immune response. Used alone, pembrolizumab provides benefit for patients with non-small cell lung cancer (NSCLC) tumors that produce PD-L1. However, when it is combined with chemotherapy, which can stimulate anticancer immune responses, pembrolizumab provides a benefit, regardless of tumor PD-L1 production. This article shows that among patients with NSCLC whose tumors produce no PD-L1, outcomes are better with pembrolizumab plus chemotherapy in comparison with chemotherapy alone.",2020,"Pembrolizumab plus chemotherapy improved overall survival (OS; hazard ratio [HR], 0.63; 95% CI, 0.50-0.79) and progression-free survival (HR, 0.68; 95% CI, 0.56-0.83) over chemotherapy.","['patients with advanced non-small cell lung cancer without tumor PD-L1 expression', 'patients with non-small cell lung cancer (NSCLC) tumors', 'patients with advanced/metastatic NSCLC negative for PD-L1 ', 'patients with NSCLC', 'patients with advanced NSCLC', 'patients with previously untreated advanced/metastatic non-small cell lung cancer (NSCLC', 'Four hundred forty-four of the 1328 patients (33.4%) who were enrolled across the 3 trials had PD-L1-negative tumors (256 on pembrolizumab plus chemotherapy [nonsquamous, n\xa0=\xa0155; squamous, n\xa0=\xa094; other, n\xa0=\xa07] and 188 on chemotherapy alone [nonsquamous, n\xa0=\xa083; squamous, n\xa0=\xa099; other, n\xa0=\xa06']","['pembrolizumab', 'pembrolizumab plus chemotherapy', 'pembrolizumab plus chemotherapy versus chemotherapy alone', 'pembrolizumab plus chemotherapy (pemetrexed and platinum for nonsquamous histology and carboplatin and paclitaxel/nab-paclitaxel', 'chemotherapy alone', 'Pembrolizumab plus platinum-based chemotherapy', 'Pembrolizumab plus chemotherapy']","['3-year OS rate', 'immune-mediated AEs and infusion reactions', 'Adverse events (AEs', 'median time', 'progression-free survival', 'objective response rate', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0278987', 'cui_str': 'Metastatic non-small cell lung cancer'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0019638', 'cui_str': 'Histology'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C4087225', 'cui_str': 'Immune-mediated adverse reaction'}, {'cui': 'C2368034', 'cui_str': 'Adverse reaction to drug or medicament administered by infusion'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",1328.0,0.416973,"Pembrolizumab plus chemotherapy improved overall survival (OS; hazard ratio [HR], 0.63; 95% CI, 0.50-0.79) and progression-free survival (HR, 0.68; 95% CI, 0.56-0.83) over chemotherapy.","[{'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Borghaei', 'Affiliation': 'Hematology and Oncology, Fox Chase Cancer Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Corey J', 'Initials': 'CJ', 'LastName': 'Langer', 'Affiliation': 'Department of Medicine, Abramson Cancer Center, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Paz-Ares', 'Affiliation': 'Department of Medical Oncology, Hospital Universitario 12 de Octubre, Universidad Complutense and CIBERONC, Madrid, Spain.'}, {'ForeName': 'Delvys', 'Initials': 'D', 'LastName': 'Rodríguez-Abreu', 'Affiliation': 'Complejo Hospitalario Universitario Insular Materno-Infantil de Gran Canaria, Universidad de Las Palmas de Gran Canaria, Las Palmas de Gran Canaria, Spain.'}, {'ForeName': 'Balazs', 'Initials': 'B', 'LastName': 'Halmos', 'Affiliation': 'Montefiore Einstein Center for Cancer Care, New York, New York.'}, {'ForeName': 'Marina C', 'Initials': 'MC', 'LastName': 'Garassino', 'Affiliation': 'Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Baerin', 'Initials': 'B', 'LastName': 'Houghton', 'Affiliation': 'Mid North Coast Cancer Institute, Port Macquarie Base Hospital, Port Macquarie, New South Wales, Australia.'}, {'ForeName': 'Takayasu', 'Initials': 'T', 'LastName': 'Kurata', 'Affiliation': 'Department of Thoracic Oncology, Kansai Medical University Hospital, Osaka, Japan.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'Jilin Cancer Hospital, Changchun, China.'}, {'ForeName': 'Jianxin', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': 'Merck & Co, Inc, Kenilworth, New Jersey.'}, {'ForeName': 'M Catherine', 'Initials': 'MC', 'LastName': 'Pietanza', 'Affiliation': 'Merck & Co, Inc, Kenilworth, New Jersey.'}, {'ForeName': 'Bilal', 'Initials': 'B', 'LastName': 'Piperdi', 'Affiliation': 'Merck & Co, Inc, Kenilworth, New Jersey.'}, {'ForeName': 'Shirish M', 'Initials': 'SM', 'LastName': 'Gadgeel', 'Affiliation': 'Rogel Cancer Center, University of Michigan, Ann Arbor, Michigan.'}]",Cancer,['10.1002/cncr.33142']
2631,32915421,Continuous Lumbar Sympathetic Blockade Enhances the Effect of Lumbar Sympatholysis on Refractory Diabetic Neuropathy: A Randomized Controlled Trial.,"INTRODUCTION


There are a number of options for the symptomatic treatment of peripheral neuropathy, but the overall treatment outcomes remain unsatisfactory.
METHODS


A total of 60 patients with refractory diabetic neuropathy were randomly assigned to two groups. Patients in Group A were treated with computed tomography (CT)-guided sympathetic neurolysis with alcohol, and patients in Group B were treated with a combined therapy of CT-guided catheterization to achieve continuous lumbar block for 4 weeks followed by neurolysis with alcohol administered via the catheter. The outcomes of these two treatment strategies were then analyzed in terms of pain relief, blood flow in the lower limb microcirculation, plasma levels of inflammatory mediators, and complications.
RESULTS


The visual analog scale (VAS) pain scores of all patients after treatment decreased significantly at the different evaluation time points compared with pre-treatment values, with the intergroup analysis revealing that the VAS scores were lower in Group B patients than in Group A patients at all post-treatment time points. Skin temperature, capillary filling time, and blood oxygen saturation level were significantly improved in all patients at the 1- and 7-day post-treatment assessment compared to pre-treatment values, but patients in Group B showed a greater improvement. The plasma levels of inflammatory mediators were lower in all patients at the 7-day post-treatment assessment compared to pre-treatment values, with those of patients in Group B being statistically significantly lower than those of patients in Group A.
CONCLUSION


Combined treatment with continuous lumbar sympathetic block followed by neurolysis with alcohol provided more benefit in all assessed outcomes than sympathetic alcohol neurolysis alone. The results show that the procedures were associated with satisfactory safety outcomes and sustained analgesic effects, thereby providing clinical evidence supporting the use of this novel treatment for patients with painful diabetic neuropathy.",2020,"The plasma levels of inflammatory mediators were lower in all patients at the 7-day post-treatment assessment compared to pre-treatment values, with those of patients in Group B being statistically significantly lower than those of patients in Group A.
CONCLUSION


Combined treatment with continuous lumbar sympathetic block followed by neurolysis with alcohol provided more benefit in all assessed outcomes than sympathetic alcohol neurolysis alone.","['Refractory Diabetic Neuropathy', '60 patients with refractory diabetic neuropathy', 'patients with painful diabetic neuropathy']","['computed tomography (CT)-guided sympathetic neurolysis with alcohol', 'CT-guided catheterization to achieve continuous lumbar block for 4 weeks followed by neurolysis with alcohol administered via the catheter', 'Lumbar Sympatholysis']","['VAS scores', 'plasma levels of inflammatory mediators', 'Skin temperature, capillary filling time, and blood oxygen saturation level', 'pain relief, blood flow in the lower limb microcirculation, plasma levels of inflammatory mediators, and complications', 'satisfactory safety outcomes and sustained analgesic effects', 'visual analog scale (VAS) pain scores']","[{'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0011882', 'cui_str': 'Diabetic neuropathy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0751074', 'cui_str': 'Neuralgia, Diabetic'}]","[{'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0196878', 'cui_str': 'Neurolysis'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C2609163', 'cui_str': 'Sympatholysis'}]","[{'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0037294', 'cui_str': 'Temperature of skin'}, {'cui': 'C0425716', 'cui_str': 'Capillary filling'}, {'cui': 'C0428174', 'cui_str': 'Hemoglobin saturation with oxygen'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0025962', 'cui_str': 'Microcirculation'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",60.0,0.0298423,"The plasma levels of inflammatory mediators were lower in all patients at the 7-day post-treatment assessment compared to pre-treatment values, with those of patients in Group B being statistically significantly lower than those of patients in Group A.
CONCLUSION


Combined treatment with continuous lumbar sympathetic block followed by neurolysis with alcohol provided more benefit in all assessed outcomes than sympathetic alcohol neurolysis alone.","[{'ForeName': 'Haiyan', 'Initials': 'H', 'LastName': 'Sun', 'Affiliation': 'Center of Anesthesiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, 100029, China.'}, {'ForeName': 'Mingwei', 'Initials': 'M', 'LastName': 'He', 'Affiliation': 'Center of Anesthesiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, 100029, China.'}, {'ForeName': 'Jinlei', 'Initials': 'J', 'LastName': 'Pang', 'Affiliation': 'Center of Anesthesiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, 100029, China.'}, {'ForeName': 'Xiangfei', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': 'Center of Anesthesiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, 100029, China.'}, {'ForeName': 'Yansong', 'Initials': 'Y', 'LastName': 'Huo', 'Affiliation': 'Center of Anesthesiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, 100029, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Center of Anesthesiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, 100029, China. majun7689@163.com.'}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-020-00918-7']
2632,32915506,The development and testing of a nurse-led smartphone-based self-management programme for diabetes patients with poor glycaemic control.,"AIMS


To describe a systematic process for the development of a nurse-led smartphone-based self-management programme for type 2 diabetes patients with poor glycaemic control in Singapore.
METHODS


A three-step process involving the application of a theoretical framework, evidence from literature, content validity, and pilot tests were conducted for the content and technical development of the programme. Content experts and lay patients evaluated the appropriateness, relevance, and comprehensibility of the newly developed Care4Diabetes application. A pilot randomized controlled trial was conducted with 40 patients recruited in Singapore. Twenty patients each were randomly allocated to the control and intervention groups. The study outcomes were collected at baseline and at 3 months thereafter.
RESULTS


The nurse-led smartphone-based self-management programme was developed with integration of the Care4Diabetes application and the web-portal system. The pilot results indicated that the effects of this smartphone-based programme on patient's health-related outcomes were comparable with those of the currently available nurse-led diabetes service.
CONCLUSION


The smartphone-based self-management intervention was deemed effective, yet full-scale randomized controlled trials are still ongoing and the results of these may provide strong evidence of the effectiveness of such an approach in improving patient care.
IMPACT


The uniqueness of this study lies in the integrated system used, which offers a clinical platform for diabetes nurses to provide personalized coaching and care to patients remotely, while monitoring patients' progress closely. By adopting such an approach, it would free up more time for nurses to cater to patients who are more critically in need of their direct attention.",2020,"The pilot results indicated that the effects of this smartphone-based programme on patient's health-related outcomes were comparable with those of the currently available nurse-led diabetes service.
","['diabetes patients with poor glycaemic control', '40 patients recruited in Singapore', 'Twenty patients each', 'type 2 diabetes patients with poor glycaemic control in Singapore']","['smartphone-based self-management intervention', 'smartphone-based programme', 'nurse-led smartphone-based self-management programme']",[],"[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0342299', 'cui_str': 'Poor glycemic control'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}]",[],40.0,0.035263,"The pilot results indicated that the effects of this smartphone-based programme on patient's health-related outcomes were comparable with those of the currently available nurse-led diabetes service.
","[{'ForeName': 'Wenru', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Alice Lee Centre for Nursing Studies, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'Michelle Tze Min', 'Initials': 'MTM', 'LastName': 'Cheng', 'Affiliation': 'Alice Lee Centre for Nursing Studies, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'Foon Leng', 'Initials': 'FL', 'LastName': 'Leong', 'Affiliation': 'Alice Lee Centre for Nursing Studies, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'Antoinette Wei Ling', 'Initials': 'AWL', 'LastName': 'Goh', 'Affiliation': 'National University Hospital, National University Health System, Singapore.'}, {'ForeName': 'Suan Tee', 'Initials': 'ST', 'LastName': 'Lim', 'Affiliation': 'National University Hospital, National University Health System, Singapore.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Alice Lee Centre for Nursing Studies, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}]",Journal of advanced nursing,['10.1111/jan.14519']
2633,32882429,"A randomized, sham-controlled trial of intraductal meibomian gland probing with or without topical antibiotic/steroid for obstructive meibomian gland dysfunction.","IMPORTANCE


Obstructive meibomian gland dysfunction (MGD) can be refractory to medical therapy. Intraductal meibomian gland (MG) probing may offer a potential therapeutic approach for these patients, but no randomized trials have been conducted to date.
OBJECTIVE


To assess clinical changes after intraductal MG probing for patients with refractory obstructive meibomian gland dysfunction.
DESIGN


Randomized, double-masked, sham-controlled clinical trial.
SETTING


Single-center, tertiary referral center.
PARTICIPANTS


42 patients with refractory obstructive MGD associated with lid tenderness.
INTERVENTIONS


Enrolled patients received one of the following treatments: 1) MG probing plus post-procedural topical sulfacetamide/prednisolone ointment (Blephamide®), 2) MG probing plus post-procedural lubricating ointment (GenTeal), or 3) sham probing plus GenTeal ointment. The probing was performed on the upper lids of both eyes.
MAIN OUTCOME MEASURES


Primary outcome measures were symptoms as measured by Ocular Surface Disease Index (OSDI) and Symptom Assessment iN Dry Eye (SANDE), as well as tear break-up time (TBUT). Secondary outcome measures were other clinical signs. Safety of the procedure was also evaluated by investigating the treatment-related adverse events. At baseline and 4 weeks after the procedure a masked observer evaluated the following outcome measures: symptom questionnaires, including OSDI and SANDE, upper lid tenderness, lid margin telangiectasia, corneal fluorescein staining, conjunctival lissamine green staining, TBUT, Schirmer's test, and meibomian glands yielding liquid secretion (MGYLS).
RESULTS


Compared to baseline, the MG probing/Blephamide® group showed significant improvements in both OSDI and SANDE scores and the MG probing/GenTeal group demonstrated a significant improvement only in SANDE score. In contrast, the Sham/GenTeal group did not show any statistically significant changes in symptoms. There were no statistically significant changes in clinical signs in any group at the 4-week visit, except for improvement of lid tenderness in the sham probing group.
CONCLUSIONS


MG probing/Blephamide® results in a significant improvement in symptoms in patients with refractory obstructive MGD without any significant effect on clinical signs. Larger studies are warranted to determine the efficacy of MG probing.
TRIAL REGISTRATION


Clinicaltrials.gov(identifier NCT02256969, Filed on 08/13/2014).",2020,"There were no statistically significant changes in clinical signs in any group at 4-week visit except for improvement of lid tenderness in the sham probing group.
","['patients with refractory obstructive meibomian gland dysfunction', 'patients with refractory obstructive MGD', 'obstructive meibomian gland dysfunction', '42 patients with refractory obstructive MGD associated with lid tenderness', 'Single-center, tertiary referral center']","['intraductal meibomian gland probing with or without topical antibiotic/steroid', 'MG probing plus post-procedural topical sulfacetamide/prednisolone ointment (Blephamide®), 2) MG probing plus post-procedural lubricating ointment (GenTeal), or 3) sham probing plus GenTeal ointment']","[""outcome measures: symptom questionnaires, including OSDI and SANDE, upper lid tenderness, lid margin telangiectasia, corneal fluorescein staining, conjunctival lissamine green staining, TBUT, Schirmer's test, and meibomian glands yielding liquid secretion (MGYLS"", 'SANDE score', 'symptoms', 'lid tenderness', 'OSDI and SANDE scores', 'clinical signs', 'symptoms as measured by Ocular Surface Disease Index (OSDI) and Symptom Assessment iN Dry Eye (SANDE), as well as tear break-up time (TBUT']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C1275684', 'cui_str': 'Meibomian gland dysfunction'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0234233', 'cui_str': 'Soreness'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}]","[{'cui': 'C1512936', 'cui_str': 'Intraductal route'}, {'cui': 'C0025181', 'cui_str': 'Structure of meibomian gland'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038670', 'cui_str': 'Sulfacetamide'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0028912', 'cui_str': 'Ointment'}, {'cui': 'C0718966', 'cui_str': 'Blephamide'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0720651', 'cui_str': 'GenTeal'}]","[{'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1557335', 'cui_str': 'Ocular surface disease'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C3494437', 'cui_str': 'Symptom Assessment'}, {'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0234233', 'cui_str': 'Soreness'}, {'cui': 'C0444582', 'cui_str': 'Structure of free margin of eyelid'}, {'cui': 'C0039446', 'cui_str': 'Telangiectasis'}, {'cui': 'C0060520', 'cui_str': 'Fluorescein'}, {'cui': 'C0332583', 'cui_str': 'Green color'}, {'cui': 'C0487602', 'cui_str': 'Staining method'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0200152', 'cui_str': ""Schirmer's test""}, {'cui': 'C0025181', 'cui_str': 'Structure of meibomian gland'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",42.0,0.276796,"There were no statistically significant changes in clinical signs in any group at 4-week visit except for improvement of lid tenderness in the sham probing group.
","[{'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Kheirkhah', 'Affiliation': 'Massachusetts Eye and Ear Infirmary, Department of Ophthalmology, Harvard Medical School, Boston, MA, USA; Department of Ophthalmology, Long School of Medicine, University of Texas Health at San Antonio, San Antonio, TX, USA.'}, {'ForeName': 'Hidenaga', 'Initials': 'H', 'LastName': 'Kobashi', 'Affiliation': 'Massachusetts Eye and Ear Infirmary, Department of Ophthalmology, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Girgis', 'Affiliation': 'Massachusetts Eye and Ear Infirmary, Department of Ophthalmology, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Arsia', 'Initials': 'A', 'LastName': 'Jamali', 'Affiliation': 'Center for Translational Ocular Immunology, USA.'}, {'ForeName': 'Joseph B', 'Initials': 'JB', 'LastName': 'Ciolino', 'Affiliation': 'Massachusetts Eye and Ear Infirmary, Department of Ophthalmology, Harvard Medical School, Boston, MA, USA. Electronic address: Joseph_Ciolino@meei.harvard.edu.'}, {'ForeName': 'Pedram', 'Initials': 'P', 'LastName': 'Hamrah', 'Affiliation': 'Massachusetts Eye and Ear Infirmary, Department of Ophthalmology, Harvard Medical School, Boston, MA, USA; Center for Translational Ocular Immunology, USA; Cornea Service, New England Eye Center, And Department of Ophthalmology, Tufts Medical Center, Tufts University School of Medicine, Boston, MA, USA. Electronic address: pedram.hamrah@tufts.edu.'}]",The ocular surface,['10.1016/j.jtos.2020.08.008']
2634,32882808,Treatment Success and User-Friendliness of An Electric Toothbrush App: A Pilot Study.,"Electronic and mobile health (eHealth/mHealth) are rapidly growing areas in medicine and digital technologies are gaining importance. In dentistry, digitalization is also an emerging topic, whereby more and more applications are being offered. As an example, using real-time feedback, digital application software (an app) was designed to help users brush their teeth more accurately. However, there is no data on the effectiveness and haptic of such apps. Therefore, a single-blinded, randomized controlled clinical trial was designed: twenty volunteers received an electric toothbrush with an associated app to assess whether the app-assisted toothbrushing is better than without. After a short period of familiarization with the electric toothbrush, plaque index (O'Leary et al. 1972) was recorded and subjects were assigned to the test (with app; n = 10) or the control group (no app; n = 10). At the end of the 2-week pilot study period, plaque was again assessed and participants in the test group completed a questionnaire about the app's user-friendliness. Statistical analysis revealed no significant differences between the test and control groups. The plaque index improved on average by 8.5% points in the test and 4.7% points in the control group. Fifty percent of the test group participants were of the opinion that they had achieved better cleaning results and would recommend the app to others, although the app contributed only marginally to increased plaque removal. However, such apps may nevertheless be helpful as motivational tools, especially when tracking and monitoring cleaning data. Therefore, more development and research on this topic is indicated.",2020,The plaque index improved on average by 8.5% points in the test and 4.7% points in the control group.,[],"['electric toothbrush', 'Electronic and mobile health (eHealth/mHealth']","['plaque index', 'plaque removal']",[],"[{'cui': 'C1740271', 'cui_str': 'Electric toothbrush'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C1328956', 'cui_str': 'eHealth'}]","[{'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]",,0.0382041,The plaque index improved on average by 8.5% points in the test and 4.7% points in the control group.,"[{'ForeName': 'Viviane', 'Initials': 'V', 'LastName': 'Humm', 'Affiliation': 'Clinic of Conservative and Preventive Dentistry, Center of Dental Medicine, University of Zurich, 8032 Zurich, Switzerland.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Wiedemeier', 'Affiliation': 'Statistical Services, Center of Dental Medicine, University of Zurich, 8032 Zurich, Switzerland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Attin', 'Affiliation': 'Clinic of Conservative and Preventive Dentistry, Center of Dental Medicine, University of Zurich, 8032 Zurich, Switzerland.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Schmidlin', 'Affiliation': 'Clinic of Conservative and Preventive Dentistry, Center of Dental Medicine, University of Zurich, 8032 Zurich, Switzerland.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Gartenmann', 'Affiliation': 'Clinic of Conservative and Preventive Dentistry, Center of Dental Medicine, University of Zurich, 8032 Zurich, Switzerland.'}]",Dentistry journal,['10.3390/dj8030097']
2635,32882958,Formative and Pilot Study for an Effectiveness-Implementation Hybrid Cluster Randomized Trial to Incorporate Oral Health Activities into Pediatric Well-Child Visits.,"Background : Dental caries in pediatric patients are noted to have broad impacts on systemic health and well-being. Thus, utilizing an effectiveness-implementation hybrid I design, the Pediatric Providers Against Cavities in Children's Teeth (PACT) trial is investigating multi-level interventions at the practice (incorporation of oral health in electronic medical record [EMR]) and provider levels (theory-based didactic and skills training to communicate oral health facts to parent/caregiver, give a prescription to see a dentist and a list of area dentists) to increase dental utilization among 3 to 6 year old Medicaid-enrolled children attending well-child visits (WCV). The formative and pilot work for the larger main trial are presented.  Methods : Formative work-Focus groups with 26 participants (Community leaders, providers, parent/caregivers); and key informant interviews with practice leadership (n = 4). Topics discussed were: core oral health (OH) information to communicate at WCVs and study logistics. Transcripts were coded and analyzed using Atlas.ti;  Pilot study  was refined using the formative findings and was conducted at two pediatric practices to test the implementation of: the provider didactic and skills training curriculum; EMR incorporation of four OH questions; logistics of incorporating OH activities at a WCV; and parent/caregiver recruitment.  Results : Formative work showed that providers and parent/caregivers required knowledge of dental caries, and a list of area Medicaid-accepting dentists. Providers and practice leadership advised on the logistics of incorporating oral health into WCVs. All groups suggested asking parent/caregivers their preferred method of contact and emphasizing importance of OH to motivate participation. Utilizing these findings, the curriculum and protocol was revised. The  pilot study  in two practices successfully implemented the protocol as follows: all seven providers were trained in two 45 min didactic education and skills session; incorporation of OH questions into practices EMR; recruited 86 child-parent dyads (95% participation) at the WCV; providers delivered the OH intervention to parent/caregivers in <2 min and 90% completed EMR documentation of OH questions. These findings were instrumental in finalizing the main PACT trial in 18 practices. The RE-AIM framework is used in the main trial to collect effectiveness and implementation measures at baseline and follow-up visits.  Conclusions : The formative and pilot findings were instrumental in refining the OH intervention and protocol which has resulted in successful implementation of the main trial.  Trial Registration : Clinical trials.gov, Registered 9 November 2017, NCT03385629.",2020,"Formative work showed that providers and parent/caregivers required knowledge of dental caries, and a list of area Medicaid-accepting dentists.","['3 to 6 year old Medicaid-enrolled children attending well-child visits (WCV', '26 participants (Community leaders, providers, parent/caregivers); and key informant interviews with practice leadership (n = 4', ""Pediatric Providers Against Cavities in Children's Teeth (PACT) trial"", 'Dental caries in pediatric patients']","['didactic education and skills session; incorporation of OH questions into practices EMR', 'OH intervention to parent/caregivers in <2 min and 90% completed EMR documentation of OH questions', ' ']",[],"[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025071', 'cui_str': 'Medicaid coverage'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C1444717', 'cui_str': 'Well child visit'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0023181', 'cui_str': 'Leadership'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0243126', 'cui_str': 'incorporation'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0175636', 'cui_str': 'Documentation procedure'}]",[],7.0,0.0641458,"Formative work showed that providers and parent/caregivers required knowledge of dental caries, and a list of area Medicaid-accepting dentists.","[{'ForeName': 'Suchitra', 'Initials': 'S', 'LastName': 'Nelson', 'Affiliation': 'Department of Community Dentistry, Case Western Reserve University School of Dental Medicine, Cleveland, OH 44106-4905, USA.'}, {'ForeName': 'Mary Beth', 'Initials': 'MB', 'LastName': 'Slusar', 'Affiliation': 'Department of Sociology, California State University Northridge, Northridge, CA 91330, USA.'}, {'ForeName': 'Shelley', 'Initials': 'S', 'LastName': 'Curtan', 'Affiliation': 'Department of Community Dentistry, Case Western Reserve University School of Dental Medicine, Cleveland, OH 44106-4905, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Selvaraj', 'Affiliation': 'Department of Community Dentistry, Case Western Reserve University School of Dental Medicine, Cleveland, OH 44106-4905, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Hertz', 'Affiliation': 'University Hospitals Cleveland Medical Center, Cleveland, OH 44106, USA.'}]",Dentistry journal,['10.3390/dj8030101']
2636,32888906,The Relevance of Dual Tasking for Improving Trunk Muscle Endurance After Back Surgery.,"OBJECTIVE


To determine the effect of dual tasking on trunk muscle endurance in patients after lumbar diskectomy.
DESIGN


Cross-sectional study.
SETTING


Rehabilitation hospital setting.
PARTICIPANTS


Individuals (N=14) undergoing primary lumbar diskectomy.
INTERVENTION


Using a randomized design on 2 separate days, muscle endurance was evaluated during prone bridging and Biering-Sorensen tests. Each test was randomly performed under 2 cognitive conditions: single task without cognitive condition and self-regulated dual task (ie, mathematical task).
MAIN OUTCOME MEASURES


The primary outcomes were time to failure and pain assessed by the visual analog scale from 0 to 100 mm. The secondary outcomes were kinesiophobia assessed by the Tampa Scale and disability assessed by the Oswestry Disability Index. Associations were tested using a repeated measures analysis of variance with relevant interaction test.
RESULTS


A significant interaction between condition, endurance tests, and kinesiophobia (P=.005) was found. The post hoc comparison showed positive effects between cognitive conditions in both endurance tests (prone bridging test: mean difference, 15.7s; 95% confidence interval [CI], 7.5-24s; P=.001; Biering-Sorensen test: mean difference, 7.9s; 95% CI, 1.9-14s; P=.014). The linear regression analysis between the Tampa Scale for Kinesiophobia and the difference of time to failure between cognitive conditions showed a positive correlation only during the Biering-Sorensen test (r=0.80; P=.001).
CONCLUSIONS


A self-regulated dual task increases trunk muscle endurance in patients after lumbar diskectomy. The results suggest that the difference observed in time to failure between the single task and dual task is associated with fear avoidance, especially during back extension. This strategy seems especially relevant for patients with high levels of fear avoidance and may be used to improve trunk muscle endurance.",2020,A significant interaction between condition x endurance tests x kinesiophobia (p = 0.005) was found.,"['Rehabilitation hospital setting', 'patients after lumbar discectomy', 'trunk muscle endurance after back surgery', 'Fourteen people undergoing primary lumbar discectomy']","['dual tasking', 'self-regulated dual task', 'single task without cognitive condition and 2) self-regulated dual task (i.e., mathematical task']","['kinesiophobia assessed by the Tampa Scale and disability assessed by the Oswestry Disability Index', 'time to failure and pain assessed by the Visual Analog Scale (VAS', 'trunk muscle endurance']","[{'cui': 'C0337962', 'cui_str': 'Rehabilitation hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0408632', 'cui_str': 'Excision of lumbar intervertebral disc'}, {'cui': 'C0581755', 'cui_str': 'Skeletal muscle structure of trunk'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0741419', 'cui_str': 'Back surgery'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0408633', 'cui_str': 'Primary lumbar discectomy'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0024934', 'cui_str': 'Mathematics'}]","[{'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0581755', 'cui_str': 'Skeletal muscle structure of trunk'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}]",14.0,0.0563876,A significant interaction between condition x endurance tests x kinesiophobia (p = 0.005) was found.,"[{'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Cruz-Montecinos', 'Affiliation': 'Laboratory of Clinical Biomechanics, Department of Physical Therapy, Faculty of Medicine, University of Chile, Santiago, Chile; Laboratory of Biomechanics and Kinesiology, San José Hospital, Santiago, Chile.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Núñez-Cortés', 'Affiliation': 'Laboratory of Clinical Biomechanics, Department of Physical Therapy, Faculty of Medicine, University of Chile, Santiago, Chile; Service of Physical Therapy, Hospital Clínico La Florida, Santiago, Chile.'}, {'ForeName': 'Benjamín', 'Initials': 'B', 'LastName': 'Guzmán-González', 'Affiliation': 'Laboratory of Clinical Biomechanics, Department of Physical Therapy, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Lars L', 'Initials': 'LL', 'LastName': 'Andersen', 'Affiliation': 'National Research Centre for the Working Environment, Copenhagen, Denmark.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'García-Massó', 'Affiliation': 'Department of Teaching of Musical, Visual and Corporal Expression, University of Valencia, Valencia, Spain; Human Movement Analysis Group, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Joaquín', 'Initials': 'J', 'LastName': 'Calatayud', 'Affiliation': 'National Research Centre for the Working Environment, Copenhagen, Denmark; Exercise Intervention for Health Research Group, Department of Physiotherapy, University of Valencia, Valencia, Spain. Electronic address: joaquin.calatayud@uv.es.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.07.015']
2637,32886710,Study of the efficacy of the Hero program: Cross-national evidence.,"The present study focuses on an analysis of the efficacy of the online intervention program called ""Hero"" for promoting prosociality and other socioemotional variables related to prosocial behavior, such as empathy, positive emotions, and forgiveness, in two Latin American countries: Argentina and Uruguay. The final Argentinean sample consisted of 579 adolescents (experimental group = 319 and control group = 260), and the Uruguayan sample consisted of 330 adolescents (experimental group = 140 and control group = 169), aged 12 to 15 years old. The 'Hero' program provided evidence of efficacy for the promotion of prosociality, empathy, positive emotions, and attitudes of forgiveness. It impacted each of the dimensions comprising these variables differently depending on the country where it was applied. We discuss the differences found in each country.",2020,"The 'Hero' program provided evidence of efficacy for the promotion of prosociality, empathy, positive emotions, and attitudes of forgiveness.","['579 adolescents (experimental group = 319 and control group = 260), and the Uruguayan sample consisted of 330 adolescents (experimental group = 140 and control group = 169), aged 12 to 15 years old']",[],[],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517669', 'cui_str': '260'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C4517719', 'cui_str': '330'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]",[],[],579.0,0.016216,"The 'Hero' program provided evidence of efficacy for the promotion of prosociality, empathy, positive emotions, and attitudes of forgiveness.","[{'ForeName': 'Belén', 'Initials': 'B', 'LastName': 'Mesurado', 'Affiliation': 'Consejo Nacional de Investigaciones Científicas y Técnicas (CONICET), Buenos Aires, Argentina.'}, {'ForeName': 'María E', 'Initials': 'ME', 'LastName': 'Oñate', 'Affiliation': 'Consejo Nacional de Investigaciones Científicas y Técnicas (CONICET), Buenos Aires, Argentina.'}, {'ForeName': 'Lucas M', 'Initials': 'LM', 'LastName': 'Rodriguez', 'Affiliation': 'Consejo Nacional de Investigaciones Científicas y Técnicas (CONICET), Buenos Aires, Argentina.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Putrino', 'Affiliation': 'Consejo Nacional de Investigaciones Científicas y Técnicas (CONICET), Buenos Aires, Argentina.'}, {'ForeName': 'Paulina', 'Initials': 'P', 'LastName': 'Guerra', 'Affiliation': 'Consejo Nacional de Investigaciones Científicas y Técnicas (CONICET), Buenos Aires, Argentina.'}, {'ForeName': 'Claudia E', 'Initials': 'CE', 'LastName': 'Vanney', 'Affiliation': 'Universidad Austral, Pilar, Argentina.'}]",PloS one,['10.1371/journal.pone.0238442']
2638,32886727,"Assessing the impact of professional lactation support frequency, duration and delivery form on exclusive breastfeeding in Lebanese mothers.","BACKGROUND


The optimal frequency, duration, and form of professional lactation support needed to continue exclusive breastfeeding (EBF) for six months have not yet been specifically identified. This study investigates the association between six-month EBF and the frequency, duration, and form (face-to-face vs. telephone contact) of professional lactation support in a cohort of Lebanese mothers, and explores barriers to EBF during the first six months postpartum.
METHODS


An observational study was nested in a breastfeeding support randomized controlled trial. Secondary analysis of data from 159 trial participants who received professional lactation support was conducted. (1) Six-month EBF with professional lactation support frequency, duration, and form was investigated using bivariate and multivariate regression analyses. (2) Barriers to breastfeeding were explored using content analysis of narrative data collected about breastfeeding mothers by the lactation experts.
RESULTS


Six-month EBF was achieved by 57/159 (35.8%) participants. Professional lactation support was received by more mothers continuing six months of EBF (100% vs. 83.3%, p = 0.001). In crude analysis, those mothers had a higher number of overall contacts with lactation experts (mean ± SD of 9.5 ± 2.9 vs. 7.0 ± 4.4, p = 0.001), and longer duration of face-to-face contacts (mean ± SD of 261.9 ± 209.1 vs. 201.0 ± 117.4 minutes, p = 0.035). In adjusted analysis, frequencies of overall and of telephone contacts with the lactation experts were positively associated with six-month EBF (OR = 1.15; 95% CI: 1.04 to 1.27, p = 0.007; OR = 1.12; 95% CI: 1.00 to 1.26, p = 0.05; respectively). Participants discontinuing EBF early were described as inexperienced, lacking breastfeeding knowledge, concerned about milk insufficiency, and showing negative attitudes towards night feeds.
CONCLUSION


Need-based telephone contact augmenting face-to-face professional lactation support may positively influence six-month EBF. Early identification of mothers at risk for early discontinuation of EBF can help tailor interventions specific to their concerns.",2020,"Professional lactation support was received by more mothers continuing six months of EBF (100% vs. 83.3%, p = 0.001).","['159 trial participants who received professional lactation support was conducted', 'Lebanese mothers']",['EBF'],[],"[{'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0026591', 'cui_str': 'Mother'}]","[{'cui': 'C0242205', 'cui_str': 'Breastfeeding, Exclusive'}]",[],,0.0567391,"Professional lactation support was received by more mothers continuing six months of EBF (100% vs. 83.3%, p = 0.001).","[{'ForeName': 'Dayane', 'Initials': 'D', 'LastName': 'Daou', 'Affiliation': 'Department of Anesthesiology, American University of Beirut, Beirut, Lebanon.'}, {'ForeName': 'Hani', 'Initials': 'H', 'LastName': 'Tamim', 'Affiliation': 'Biostatistics Unit, Faculty of Medicine, Clinical Research Institute, American University of Beirut, Beirut, Lebanon.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Nabulsi', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, American University of Beirut, Beirut, Lebanon.'}]",PloS one,['10.1371/journal.pone.0238735']
2639,32891607,Partial sleep deprivation affects endurance performance and psychophysiological responses during 12-minute self-paced running exercise.,"PURPOSE


This study aimed to investigate the effects of partial sleep deprivation (PSD) on physical performance and psychophysiological responses during 12-minute self-paced running exercise.
METHODS


Twenty runners (20.8±1.1 years, 70.6±4.9 kg, 175.1±3.9 cm) performed, in a randomized order, two running self-paced field exercises after a normal sleep night (CONT, bedtime from 22:30 h to 06:30 h) and one night of PSD (bedtime from 00:30 h to 04:30 h). Core temperature and motivation were recorded before exercise. Speed, covered distance, heart rate (HR), rating of perceived exertion (RPE) and respiratory parameters (i.e., minute ventilation (VE), oxygen uptake (VO 2 ) and carbon dioxide production (VCO 2 )) were assessed during exercise. Blood lactate concentration [La] was assessed 2 min after exercise. Simple reaction time (SRT), mood and barrage test (BT) were assessed before and after exercise.
RESULTS


Higher RPE (p=0.01, d=0.90) and lower physical performance (i.e., p=0.001, d=0.59 for running speed and p=0.01, d=0.7 and Δ (%)=-6% for covered distance), following PSD, were obtained compared to CONT. Similarly, PSD attenuated core temperature (p=0.01, d=0.84), HR (p=0.006, ɳp 2 =0.45), VE (p=0.001, ɳp 2 =0.73), VO 2  (p=0.001, ɳp 2 =0.96), BT (p<0.0005, ɳp 2 =0.86), SRT (p=0.0009, ɳp 2 =0.44) and mood (p<0.0005). However, VCO 2 , [La] and motivation score were not affected by sleep conditions.
CONCLUSION


The decrease of running performance and the increase of physical discomfort after PSD could be the origin of the lower cardio-respiratory responses to the 12-minute self-paced exercise. Effective strategies should be introduced to overcome the deterioration of physical performance and physiological responses after PSD.",2020,"RESULTS


Higher RPE (p=0.01, d=0.90) and lower physical performance (i.e., p=0.001, d=0.59 for running speed and p=0.01, d=0.7 and Δ (%)=","['Twenty runners (20.8±1.1 years, 70.6±4.9 kg, 175.1±3.9 cm']","['12-minute self-paced running exercise', 'Partial sleep deprivation', 'running self-paced field exercises after a normal sleep night (CONT, bedtime from 22:30 h to 06:30 h) and one night of PSD', 'partial sleep deprivation (PSD']","['PSD attenuated core temperature', 'running performance', 'SRT', 'VCO 2 , [La] and motivation score', 'physical performance and psychophysiological responses', 'endurance performance and psychophysiological responses', 'Blood lactate concentration [La', 'Simple reaction times (SRT), mood and barrage test (BT', 'Core temperature and motivation', 'Speed, covered distance, heart rate (HR), rating of perceived exertion (RPE) and respiratory parameters (i.e., minute ventilation (VE), oxygen uptake (VO 2 ) and carbon dioxide production (VCO 2 ', 'lower physical performance', 'physical discomfort']","[{'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0287990', 'cui_str': 'Furin'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0037316', 'cui_str': 'Sleep deprivation'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0521112', 'cui_str': 'Bedtime'}]","[{'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0037316', 'cui_str': 'Sleep deprivation'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1301655', 'cui_str': 'Minute ventilation'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}]",,0.0445421,"RESULTS


Higher RPE (p=0.01, d=0.90) and lower physical performance (i.e., p=0.001, d=0.59 for running speed and p=0.01, d=0.7 and Δ (%)=","[{'ForeName': 'Wajdi', 'Initials': 'W', 'LastName': 'Souissi', 'Affiliation': 'Interdisciplinary Laboratory in Neurosciences, Physiology and Psychology: Physical activity, Health and learning (LINP2-2APS), UFR STAPS, UPL, Paris Nanterre University, Nanterre, France.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Hammouda', 'Affiliation': 'Interdisciplinary Laboratory in Neurosciences, Physiology and Psychology: Physical activity, Health and learning (LINP2-2APS), UFR STAPS, UPL, Paris Nanterre University, Nanterre, France; Research Laboratory, Molecular Bases of Human Pathology, LR19ES13, Faculty of Medicine, University of Sfax, Sfax, Tunisia.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Ayachi', 'Affiliation': 'Interdisciplinary Laboratory in Neurosciences, Physiology and Psychology: Physical activity, Health and learning (LINP2-2APS), UFR STAPS, UPL, Paris Nanterre University, Nanterre, France.'}, {'ForeName': 'Achraf', 'Initials': 'A', 'LastName': 'Ammar', 'Affiliation': 'Institute of Sport Science, Otto-von-Guericke University, Magdeburg, Germany.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Khcharem', 'Affiliation': 'Research Laboratory, Education, Motricity, Sport and Health, UR15JS01, High Institute of Sport and Physical Education, University of Sfax, Tunisia; Laboratory of Pharmacology, Faculty of Medicine, University of Sfax, Tunisia.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'de Marco', 'Affiliation': 'Interdisciplinary Laboratory in Neurosciences, Physiology and Psychology: Physical activity, Health and learning (LINP2-2APS), UFR STAPS, UPL, Paris Nanterre University, Nanterre, France.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Souissi', 'Affiliation': 'Research Laboratory, Education, Motricity, Sport and Health, UR15JS01, High Institute of Sport and Physical Education, University of Sfax, Tunisia.'}, {'ForeName': 'Tarak', 'Initials': 'T', 'LastName': 'Driss', 'Affiliation': 'Interdisciplinary Laboratory in Neurosciences, Physiology and Psychology: Physical activity, Health and learning (LINP2-2APS), UFR STAPS, UPL, Paris Nanterre University, Nanterre, France. Electronic address: tarak.driss@parisnanterre.fr.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113165']
2640,32891678,The impact of shared decision making with patient decision aids on the rotavirus vaccination rate in children: A randomized controlled trial.,"Rotavirus vaccination reduces the incidence and severity of acute gastroenteritis due to rotavirus infection. However, because of a lack of understanding and private payment for the rotavirus vaccine, the rotavirus vaccination rate is still low in some countries. We intended to assess the impact of shared decision-making (SDM) with the assistance of patient decision aids (PDAs) on the rotavirus vaccination rate, and the knowledge, confidence, and congruence of value among baby's parents when decision-making. The study was a two-group, outcome assessor-blind, randomized, controlled trial. The families of 1-month-old infants for routine vaccination were enrolled; they were divided randomly into non-SDM and SDM groups. The influence of SDM on the acceptance of rotavirus vaccination was assessed when their infants were 2 months old. Outcome measures were decisional conflict, decision-making difficulties, and rotavirus vaccine knowledge, and the overall rotavirus vaccination rate. The study enrolled 180 participants. SDM, parents' education level, and rotavirus vaccination of a previous child were variables that influenced acceptance of rotavirus vaccination. The SDM group scored significantly higher for understanding the information on the oral rotavirus vaccine than the non-SDM group, which helped them to decide whether to vaccinate the baby against rotavirus. The rotavirus vaccination rate was 16.7% higher in the SDM group than the non-SDM group. SDM assisted with PDAs gives more information and helps infants' families understand what they need, reduces their decision conflict, and increases their baby's vaccination against rotavirus, which promotes public health. The clinical trial is registered at ClinicalTrials.gov (NCT03804489).",2020,"The SDM group scored significantly higher for understanding the information on the oral rotavirus vaccine than the non-SDM group, which helped them to decide whether to vaccinate the baby against rotavirus.","['children', '180 participants', 'families of 1-month-old infants for routine vaccination were enrolled']","['shared decision-making (SDM) with the assistance of patient decision aids (PDAs', 'Rotavirus vaccination', 'SDM', 'patient decision aids', 'SDM assisted with PDAs']","['acceptance of rotavirus vaccination', 'rotavirus vaccination rate', 'decisional conflict, decision-making difficulties, and rotavirus vaccine knowledge, and the overall rotavirus vaccination rate', 'rotavirus vaccination rate, and the knowledge, confidence, and congruence of value']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0857208', 'cui_str': 'Routine vaccination'}]","[{'cui': 'C3179495', 'cui_str': 'Decision Making, Shared'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C1532786', 'cui_str': 'Rotavirus vaccination'}]","[{'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C1532786', 'cui_str': 'Rotavirus vaccination'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0597418', 'cui_str': 'Rotavirus vaccine'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",180.0,0.124641,"The SDM group scored significantly higher for understanding the information on the oral rotavirus vaccine than the non-SDM group, which helped them to decide whether to vaccinate the baby against rotavirus.","[{'ForeName': 'Sheng-Chieh', 'Initials': 'SC', 'LastName': 'Lin', 'Affiliation': 'Division of Allergy, Asthma, and Immunology, Department of Pediatrics, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan; Department of Pediatrics, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan. Electronic address: jacklinmails@yahoo.com.tw.'}, {'ForeName': 'Ka-Wai', 'Initials': 'KW', 'LastName': 'Tam', 'Affiliation': 'Division of General Surgery, Department of Surgery, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan; Division of General Surgery, Department of Surgery, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan; Cochrane Taiwan, Taipei Medical University, Taipei, Taiwan; Shared Decision Making Resource Center, Department of Medical Research, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan. Electronic address: kelvintam@h.tmu.edu.tw.'}, {'ForeName': 'Jean Yu-Chun', 'Initials': 'JY', 'LastName': 'Yen', 'Affiliation': 'Research Center of Biostatistics, College of Management, Taipei Medical University, Taipei, Taiwan. Electronic address: jeanycy@tmu.edu.tw.'}, {'ForeName': 'Meng-Che', 'Initials': 'MC', 'LastName': 'Lu', 'Affiliation': 'Division of Allergy, Asthma, and Immunology, Department of Pediatrics, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Elaine Ying-Fang', 'Initials': 'EY', 'LastName': 'Chen', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Yung-Ting', 'Initials': 'YT', 'LastName': 'Kuo', 'Affiliation': 'Department of Pediatrics, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan; Division of Pediatric Neurology, Department of Pediatrics, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan. Electronic address: pedkuoyt@tmu.edu.tw.'}, {'ForeName': 'Wen-Chuan', 'Initials': 'WC', 'LastName': 'Lin', 'Affiliation': 'Division of Pediatric Infectious Diseases, Department of Pediatrics, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan. Electronic address: 09009@s.tmu.edu.tw.'}, {'ForeName': 'Shu-Huey', 'Initials': 'SH', 'LastName': 'Chen', 'Affiliation': 'Department of Pediatrics, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan; Division of Pediatric Hematology and Oncology, Department of Pediatrics, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan. Electronic address: shu117@tmu.edu.tw.'}, {'ForeName': 'El-Wui', 'Initials': 'EW', 'LastName': 'Loh', 'Affiliation': 'Cochrane Taiwan, Taipei Medical University, Taipei, Taiwan; Shared Decision Making Resource Center, Department of Medical Research, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan; Graduate Institute of Clinical Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan; Center for Evidence-Based Health Care, Department of Medical Research, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan. Electronic address: lohelwui@tmu.edu.tw.'}, {'ForeName': 'Shih-Yen', 'Initials': 'SY', 'LastName': 'Chen', 'Affiliation': 'Department of Pediatrics, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan; Division of Pediatric Gastroenterology, Department of Pediatrics, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan. Electronic address: 18159@s.tmu.edu.tw.'}]",Preventive medicine,['10.1016/j.ypmed.2020.106244']
2641,32890814,Did young women in South African informal settlements display increased agency after participating in the Stepping Stones and Creating Futures intervention? A qualitative evaluation.,"This paper investigates the impact of the Stepping Stones Creating Futures (SSCF) intervention on young women in informal settlements in eThekwini, South Africa. Specifically, whether following participation in the intervention the young women experienced a reduction in intimate partner violence, strengthened agency and shifted gender relations. Where changes occurred, it examines how they occurred, and barriers and enablers to change. SSCF is a gender transformative and livelihoods strengthening intervention using participatory, reflective small groups. Qualitative research was undertaken with fifteen women participating in the SSCF randomised control trial between 2015 and 2018. The women were followed over 18 months, participating in in-depth interviews at baseline, 12- and 18-months post intervention. To supplement these, eight women were involved in Photovoice work at baseline and 18 months and seven were included in ongoing participant observation. Data were analysed inductively. Data revealed many women changed their behaviours following SSCF, including: having more power within relationships, improved communication and relationship skills, increased resistance to controlling partners, shifting relationship expectations, emergence of new femininities and improved livelihoods. Despite these important shifts many women did not report a reduction in IPV. Nonetheless we argue most of the women, following the intervention, became more agentic. Drawing on the notion of 'distributed agency' as developed by Campbell and Mannell (2016), we show that SSCF bolstered the women's distributed agency. Distributed agency recognizes small agentic acts that women take, acts which to them are significant, it further notes that agency is temporal, fluid, dynamic and context specific. Women do not 'either have agency or not', rather being agentic depends on time, context and the particular incident. These findings provide an important contribution to the limited application of distributed agency and femininities work in informal settlements and are critical for policy and intervention science to reduce IPV and support women's agency.",2020,"Data revealed many women changed their behaviours following SSCF, including: having more power within relationships, improved communication and relationship skills, increased resistance to controlling partners, shifting relationship expectations, emergence of new femininities and improved livelihoods.","['young women in informal settlements in eThekwini, South Africa', 'fifteen women participating in the SSCF randomised control trial between 2015 and 2018', 'eight women were involved in Photovoice work at baseline and 18 months and seven were included in ongoing participant observation']","['SSCF', 'Stepping Stones Creating Futures (SSCF) intervention']","['communication and relationship skills, increased resistance to controlling partners, shifting relationship expectations, emergence of new femininities and improved livelihoods', 'intimate partner violence, strengthened agency and shifted gender relations']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0558038', 'cui_str': 'Participant observation'}]","[{'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0233894', 'cui_str': 'Femininity'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0242360', 'cui_str': 'Relations, Gender'}]",15.0,0.0551815,"Data revealed many women changed their behaviours following SSCF, including: having more power within relationships, improved communication and relationship skills, increased resistance to controlling partners, shifting relationship expectations, emergence of new femininities and improved livelihoods.","[{'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Willan', 'Affiliation': 'Gender and Health Research Unit, South African Medical Research Council, 1 Soutpansberg Road, Pretoria, South Africa. Electronic address: Samantha.willan@mrc.ac.za.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Gibbs', 'Affiliation': 'Gender and Health Research Unit, South African Medical Research Council, 1 Soutpansberg Road, Pretoria, South Africa; Centre for Rural Health, School of Nursing and Public Health, Mazisi Kunene Road, University of KwaZulu-Natal, Durban, 4041, South Africa.'}, {'ForeName': 'Nwabisa', 'Initials': 'N', 'LastName': 'Shai', 'Affiliation': 'Gender and Health Research Unit, South African Medical Research Council, 1 Soutpansberg Road, Pretoria, South Africa.'}, {'ForeName': 'Nolwazi', 'Initials': 'N', 'LastName': 'Ntini', 'Affiliation': 'Gender and Health Research Unit, South African Medical Research Council, 1 Soutpansberg Road, Pretoria, South Africa.'}, {'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Petersen', 'Affiliation': 'Centre for Rural Health, School of Nursing and Public Health, Mazisi Kunene Road, University of KwaZulu-Natal, Durban, 4041, South Africa.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Jewkes', 'Affiliation': 'Gender and Health Research Unit, South African Medical Research Council, 1 Soutpansberg Road, Pretoria, South Africa.'}]",Social science & medicine (1982),['10.1016/j.socscimed.2020.113302']
2642,32896753,Proprioceptive neuromuscular facilitation in the functionality and lymphatic circulation of the upper limb of women undergoing breast cancer treatment.,"BACKGROUND


With the increase in survival of women treated for breast cancer, it is necessary to evaluate the effect of therapeutic resources on co-morbidities resulting from the surgical treatment of the disease. The aim of this study was to evaluate the effects of proprioceptive neuromuscular facilitation on the functionality and lymphatic circulation of the upper limb involved in the treatment of breast cancer.
METHODS


The study was conducted according to randomized clinical trial design. Thirty-two women at a mean age of 52.20 (±8.32) years, submitted to breast cancer treatment, divided into two groups, control - women submitted to standard breast cancer treatment, and treated group, composed of women who underwent breast cancer treatment and rehabilitation with the proprioceptive neuromuscular facilitation technique. Palmar grip strength with dynamometer and shoulder range of motion with goniometer were evaluated. Lymphatic circulation analysis was performed in a computerized scintillation chamber, before and after therapeutic intervention.
FINDINGS


In the results obtained, a significant increase (p < 0.05) of palmar grip strength was observed, a significant increase in range of motion of flexion (p < 0.001), extension (p < 0.0012), abduction (p < 0.0001), external rotation (p < 0.0001), internal rotation (p < 0.0001), and not significant for lymphatic flow (p > 0.05).
INTERPRETATION


The results obtained in this study allow us to conclude that proprioceptive neuromuscular facilitation favors an increase in muscle strength, range of motion, but not in lymphatic flow, in women undergoing surgical treatment for breast cancer.",2020,"In the results obtained, a significant increase (p < 0.05) of palmar grip strength was observed, a significant increase in range of motion of flexion (p < 0.001), extension (p < 0.0012), abduction (p < 0.0001), external rotation (p < 0.0001), internal rotation (p < 0.0001), and not significant for lymphatic flow (p > 0.05).
","['women undergoing surgical treatment for breast cancer', 'women undergoing breast cancer treatment', 'Thirty-two women at a mean age of 52.20 (±8.32) years, submitted to breast cancer treatment']","['proprioceptive neuromuscular facilitation', 'Proprioceptive neuromuscular facilitation', 'breast cancer treatment and rehabilitation with the proprioceptive neuromuscular facilitation technique', 'control - women submitted to standard breast cancer treatment']","['muscle strength, range of motion', 'palmar grip strength', 'internal rotation', 'lymphatic flow', 'range of motion of flexion', 'Palmar grip strength with dynamometer and shoulder range of motion with goniometer', 'external rotation']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0037415', 'cui_str': 'Social Facilitation'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0454481', 'cui_str': 'Proprioceptive neuromuscular facilitation technique'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0575813', 'cui_str': 'Palmar grip'}, {'cui': 'C0231459', 'cui_str': 'Internal rotation'}, {'cui': 'C0024235', 'cui_str': 'Structure of lymphatic system'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0180572', 'cui_str': 'Dynamometer'}, {'cui': 'C0575545', 'cui_str': 'Shoulder joint - range of movement'}, {'cui': 'C0231462', 'cui_str': 'External rotation'}]",32.0,0.0146829,"In the results obtained, a significant increase (p < 0.05) of palmar grip strength was observed, a significant increase in range of motion of flexion (p < 0.001), extension (p < 0.0012), abduction (p < 0.0001), external rotation (p < 0.0001), internal rotation (p < 0.0001), and not significant for lymphatic flow (p > 0.05).
","[{'ForeName': 'Daniela Santana Polati', 'Initials': 'DSP', 'LastName': 'da Silveira', 'Affiliation': 'Postgraduate Program in Rehabilitation and Functional Performance, São Paulo University, Ribeirão Preto, São Paulo, Brazil. Electronic address: daniela.silveira@unifran.edu.br.'}, {'ForeName': 'Marcelo José', 'Initials': 'MJ', 'LastName': 'Dos Santos', 'Affiliation': 'Departament of Nuclear Medicine, Câncer Hospital of Barretos, Barretos, SP, Brazil.'}, {'ForeName': 'Eduardo Tinóis', 'Initials': 'ET', 'LastName': 'da Silva', 'Affiliation': 'Departament of Physics in Nuclear Medicine, Radiation Safety and Technology Institute, Campinas, SP, Brazil.'}, {'ForeName': 'Almir José', 'Initials': 'AJ', 'LastName': 'Sarri', 'Affiliation': 'Departament of Physiotherapy, Câncer Hospital of Barretos, Barretos, SP, Brazil.'}, {'ForeName': 'Lais Mara Siqueira', 'Initials': 'LMS', 'LastName': 'das Neves', 'Affiliation': 'Postgraduate Program in Rehabilitation and Functional Performance, São Paulo University, Ribeirão Preto, São Paulo, Brazil.'}, {'ForeName': 'Elaine Caldeira de Oliveira', 'Initials': 'ECO', 'LastName': 'Guirro', 'Affiliation': 'Postgraduate Program in Rehabilitation and Functional Performance, São Paulo University, Ribeirão Preto, São Paulo, Brazil; Department of Health Sciences, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, SP, Brazil. Electronic address: ecguirro@fmrp.usp.br.'}]","Clinical biomechanics (Bristol, Avon)",['10.1016/j.clinbiomech.2020.105158']
2643,32896776,The long-term influence of hospital and surgeon volume on local control and survival in the randomized German Rectal Cancer Trial CAO/ARO/AIO-94.,"BACKGROUND


The association of treatment volume and oncological outcome of rectal cancer patients undergoing multidisciplinary treatment is subject of an ongoing debate. Prospective data on long-term local control and overall survival (OS) are not available so far. This study investigated the long-term influence of hospital and surgeon volume on local recurrence (LR) and OS in patients with locally advanced rectal cancers.
METHODS


In a post-hoc analysis of the randomized phase III CAO/ARO/AIO-94 trial after a follow-up of more than 10 years, 799 patients with stage II/III rectal cancers were evaluated. LR-rates and OS were stratified by hospital recruitment volume (≤20 vs. 21-90 vs. >90 patients) and by surgeon volume (≤10 vs. 11-50 vs. >50 procedures).
RESULTS


Patients treated in high-volume hospitals had a longer OS than those treated in hospitals with medium or low treatment volume (p = 0.03). The surgeon volume was adversely associated with LR (p = 0.01) but had no influence on overall survival. The positive effect of neoadjuvant chemoradiation (CRT) on local control was the strongest in patients being operated by medium-volume surgeons, less in patients being operated by high-volume surgeons and missing in those being operated by low-volume surgeons.
CONCLUSIONS


Patients with locally advanced rectal cancers might benefit from treatment in specialized high-volume hospitals. In particular, the surgeon volume had significant influence on long-term local tumour control. The effect of neoadjuvant CRT on local tumour control may likewise depend on the surgeon volume.",2020,"RESULTS


Patients treated in high-volume hospitals had a longer OS than those treated in hospitals with medium or low treatment volume (p = 0.03).","['799 patients with stage II/III rectal cancers', 'Patients with locally advanced rectal cancers', 'patients with locally advanced rectal cancers', 'rectal cancer patients undergoing']","['neoadjuvant CRT', 'multidisciplinary treatment', 'neoadjuvant chemoradiation (CRT']","['overall survival (OS', 'LR-rates and OS', 'longer OS', 'long-term local tumour control', 'local control and survival', 'overall survival', 'local recurrence (LR) and OS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}]","[{'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",799.0,0.0971685,"RESULTS


Patients treated in high-volume hospitals had a longer OS than those treated in hospitals with medium or low treatment volume (p = 0.03).","[{'ForeName': 'Thilo', 'Initials': 'T', 'LastName': 'Sprenger', 'Affiliation': 'Department of General, Visceral and Pediatric Surgery, University Medical Center Göttingen, Göttingen, Germany. Electronic address: thilo.sprenger@chiru.med.uni-giessen.de.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Beißbarth', 'Affiliation': 'Department of Medical Statistics, University Medical Center Göttingen, Göttingen, Germany.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Sauer', 'Affiliation': 'Department of Radiotherapy, University Medical Center Erlangen, Erlangen, Germany.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Tschmelitsch', 'Affiliation': 'Department of Surgery, Krankenhaus der Barmherzigen Brüder, St. Veit an der Glan, Austria.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Fietkau', 'Affiliation': 'Department of Radiotherapy, University Medical Center Erlangen, Erlangen, Germany.'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Hohenberger', 'Affiliation': 'Department of Surgery, University Medical Center Erlangen, Erlangen, Germany.'}, {'ForeName': 'Ludger', 'Initials': 'L', 'LastName': 'Staib', 'Affiliation': 'Department of General and Visceral Surgery, Klinikum Esslingen, Esslingen, Germany.'}, {'ForeName': 'Hans-Rudolf', 'Initials': 'HR', 'LastName': 'Raab', 'Affiliation': 'University Department of General and Visceral Surgery, Klinikum Oldenburg, Oldenburg, Germany.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Rödel', 'Affiliation': 'Department of Radiotherapy and Oncology, University Medical Center Frankfurt, Frankfurt/Main, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Ghadimi', 'Affiliation': 'Department of General, Visceral and Pediatric Surgery, University Medical Center Göttingen, Göttingen, Germany.'}]",Surgical oncology,['10.1016/j.suronc.2020.08.021']
2644,32898517,Cardiac autonomic and blood pressure responses to an acute session of battling ropes exercise.,"BACKGROUND


Battling rope (BTR) exercise has become incredibly popular among not only fitness enthusiasts and athletes but in the general exercising population. Despite its popularity, research regarding the acute cardiovascular responses to BTR exercise is limited. This investigation evaluated the effects of acute BTR exercise on heart rate variability (HRV) and blood pressure (BP) responses in young men with elevated BP.
MATERIALS AND METHODS


Eleven young men with elevated BP completed either a BTR or a non-exercise control trial in randomized order. The BTR trial consisted of 10 rounds of BTR exercise. Each round included 30 s of exercise followed by 30 s of rest. HRV and BP were evaluated at baseline and 3, 10, and 30 min following each trial.
RESULTS


There were significant elevations (p ˂0.01) in heart rate, markers of sympathetic activity (nLF), and sympathovagal balance (LnLF/LnHF, nLF/nHF) for 30 min following the BTR trial, whereas no changes from baseline were detected after control. Additionally, there were significant reductions (p ˂0.01) in markers of vagal tone (RMSSD, LnHF and nHF) and LnLF (both sympathetic and vagal modulations) for 30 min; as well as (p ˂0.01) systolic BP and diastolic BP at 10 and 30 min after the BTR, but not the control trial.
CONCLUSION


Current findings revealed that BTR exercise elevates sympathovagal balance for 30 min post-intervention, which is concurrent with an impressive hypotensive effect. Further investigations are warranted to assess the potential clinical application of BTR exercise not only in cohorts needing BP control but also in populations with limited locomotion that might benefit from post-exercise hypotension.",2020,"There were significant elevations (p ˂0.01) in heart rate, markers of sympathetic activity (nLF), and sympathovagal balance (LnLF/LnHF, nLF/nHF) for 30 minutes following the BTR trial, whereas no changes from baseline were detected after control.","['young men with elevated BP', 'Eleven young men with elevated BP completed either a']","['Battling rope (BTR) exercise', 'BTR or a non-exercise control', 'acute BTR exercise', 'BTR exercise']","['systolic BP and diastolic BP', 'sympathovagal balance', 'heart rate, markers of sympathetic activity (nLF), and sympathovagal balance (LnLF/LnHF, nLF/nHF', 'Cardiac Autonomic and Blood Pressure Responses', 'HRV and BP', 'heart rate variability (HRV) and blood pressure (BP) responses', 'vagal tone (RMSSD, LnHF and nHF) and LnLF (both sympathetic and vagal modulations']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C1997183', 'cui_str': 'Speed of blood pressure response'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}]",11.0,0.10577,"There were significant elevations (p ˂0.01) in heart rate, markers of sympathetic activity (nLF), and sympathovagal balance (LnLF/LnHF, nLF/nHF) for 30 minutes following the BTR trial, whereas no changes from baseline were detected after control.","[{'ForeName': 'Alexei', 'Initials': 'A', 'LastName': 'Wong', 'Affiliation': 'Department of Health and Human Performance, Marymount University, 2807 North Glebe Road, Arlington, VA 22207, United States. Electronic address: awong@marymount.edu.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Bergen', 'Affiliation': 'Department of Health and Human Performance, Marymount University, 2807 North Glebe Road, Arlington, VA 22207, United States.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Nordvall', 'Affiliation': 'Department of Health and Human Performance, Marymount University, 2807 North Glebe Road, Arlington, VA 22207, United States.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Allnutt', 'Affiliation': 'Department of Health and Human Performance, Marymount University, 2807 North Glebe Road, Arlington, VA 22207, United States.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Bagheri', 'Affiliation': 'Department of Exercise Physiology, University of Isfahan, Isfahan, Iran.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113167']
2645,32899135,Impact of a Three-Year Obesity Prevention Study on Healthy Behaviors and BMI among Lebanese Schoolchildren: Findings from Ajyal Salima Program.,"Most school-based obesity prevention programs in low- to middle-income countries are of short duration, and few undertake follow-up analyses after the termination of the project. The aims of the current study are to investigate (1) the long-term effects of a school-based intervention program when implemented over two years on body mass index (BMI), healthy dietary behaviors, and physical activity (PA); and (2) whether the effects are sustained after one-year washout. The study is a cluster-randomized trial; 36 public and private schools were randomized into either intervention or control groups. Students (8-12 years) completed pre-and post-assessment anthropometric measurements and questionnaires about their eating and physical activity habits. Students in the intervention groups received the program components for two consecutive years. Multiple logistic regression models were used to examine the effect of the intervention on BMI and healthy behaviors. Students in the intervention groups were less likely to be overweight at washout, only in public schools. The number of children reporting change in dietary behaviors significantly increased in intervention groups, with a sustained effect only in public schools. Policies aiming at securing a positive nutrition environment in schools, and adoption of nutrition programs, are needed for achieving sustained behavior and prompting BMI changes in children.",2020,"The number of children reporting change in dietary behaviors significantly increased in intervention groups, with a sustained effect only in public schools.","['Healthy Behaviors and BMI among Lebanese Schoolchildren', '36 public and private schools']",['school-based intervention program'],"['body mass index (BMI), healthy dietary behaviors, and physical activity (PA', 'BMI and healthy behaviors', 'dietary behaviors']","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0033175', 'cui_str': 'Private Room'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",36.0,0.0164201,"The number of children reporting change in dietary behaviors significantly increased in intervention groups, with a sustained effect only in public schools.","[{'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Habib-Mourad', 'Affiliation': 'Department of Nutrition and Food Sciences, Faculty of Agriculture and Food Sciences, American University of Beirut, Beirut 11-0236, Lebanon.'}, {'ForeName': 'Lilian A', 'Initials': 'LA', 'LastName': 'Ghandour', 'Affiliation': 'Department of Epidemiology and Population Health, Faculty of Health Sciences, American University of Beirut, Beirut 11-0236, Lebanon.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Maliha', 'Affiliation': 'Department of Nutrition and Food Sciences, Faculty of Agriculture and Food Sciences, American University of Beirut, Beirut 11-0236, Lebanon.'}, {'ForeName': 'Michèle', 'Initials': 'M', 'LastName': 'Dagher', 'Affiliation': 'Department of Nutrition and Food Sciences, Faculty of Agriculture and Food Sciences, American University of Beirut, Beirut 11-0236, Lebanon.'}, {'ForeName': 'Samer', 'Initials': 'S', 'LastName': 'Kharroubi', 'Affiliation': 'Department of Nutrition and Food Sciences, Faculty of Agriculture and Food Sciences, American University of Beirut, Beirut 11-0236, Lebanon.'}, {'ForeName': 'Nahla', 'Initials': 'N', 'LastName': 'Hwalla', 'Affiliation': 'Department of Nutrition and Food Sciences, Faculty of Agriculture and Food Sciences, American University of Beirut, Beirut 11-0236, Lebanon.'}]",Nutrients,['10.3390/nu12092687']
2646,32899227,"Ubiquinone Supplementation with 300 mg on Glycemic Control and Antioxidant Status in Athletes: A Randomized, Double-Blinded, Placebo-Controlled Trial.","The aim of this study is to investigate the glycemic profile, oxidative stress, and antioxidant capacity in athletes after 12 weeks of ubiquinone supplementation. It was a double-blinded, randomized, parallel, placebo-controlled study. Thirty-one well-trained college athletes were randomly assigned to ubiquinone (300 mg/d,  n  = 17) or placebo group ( n  = 14). The glycemic profile [fasting glucose, glycated hemoglobin (HbA1c), homeostatic model assessment-insulin resistance (HOMA-IR), quantitative insulin sensitivity check index (QUICKI)], plasma and erythrocyte malondialdehyde (MDA), total antioxidant capacity (TAC), and ubiquinone status were measured. After supplementation, the plasma ubiquinone concentration was significantly increased ( p  < 0.05) and the level of erythrocyte MDA was significantly lower in the ubiquinone group than in the placebo group ( p  < 0.01). There was a significant correlation between white blood cell (WBC) ubiquinone and glycemic parameters [HbA1c,  r  = -0.46,  p  < 0.05; HOMA-IR,  r  = -0.67,  p  < 0.01; QUICKI,  r  = 0.67,  p  < 0.01]. In addition, athletes with higher WBC ubiquinone level (≥0.5 nmol/g) showed higher erythrocyte TAC and QUICKI and lower HOMA-IR. In conclusion, we demonstrated that athletes may show a better antioxidant capacity with higher ubiquinone status after 12 weeks of supplementation, which may further improve glycemic control.",2020,"After supplementation, the plasma ubiquinone concentration was significantly increased ( p  < 0.05) and the level of erythrocyte MDA was significantly lower in the ubiquinone group than in the placebo group ( p  < 0.01).","['Athletes', 'athletes after 12 weeks of ubiquinone supplementation', 'Thirty-one well-trained college athletes']","['placebo', 'Placebo', 'ubiquinone', 'Ubiquinone Supplementation']","['erythrocyte TAC and QUICKI and lower HOMA-IR', 'WBC ubiquinone level', 'plasma ubiquinone concentration', 'level of erythrocyte MDA', 'white blood cell (WBC) ubiquinone and glycemic parameters', 'glycemic profile [fasting glucose, glycated hemoglobin (HbA1c), homeostatic model assessment-insulin resistance (HOMA-IR), quantitative insulin sensitivity check index (QUICKI)], plasma and erythrocyte malondialdehyde (MDA), total antioxidant capacity (TAC), and ubiquinone status', 'glycemic profile, oxidative stress, and antioxidant capacity', 'glycemic control']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0041536', 'cui_str': 'Coenzyme Q'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0557806', 'cui_str': 'College'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0041536', 'cui_str': 'Coenzyme Q'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C3489891', 'cui_str': 'TAC Alternate'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C1532468', 'cui_str': 'Ubiquinone level'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0041536', 'cui_str': 'Coenzyme Q'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0000379', 'cui_str': 'Methylenedioxyamphetamine'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C1283174', 'cui_str': 'Checking - action'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",31.0,0.298316,"After supplementation, the plasma ubiquinone concentration was significantly increased ( p  < 0.05) and the level of erythrocyte MDA was significantly lower in the ubiquinone group than in the placebo group ( p  < 0.01).","[{'ForeName': 'Chien-Chang', 'Initials': 'CC', 'LastName': 'Ho', 'Affiliation': 'Department of Physical Education, Fu Jen Catholic University, New Taipei City 242304, Taiwan.'}, {'ForeName': 'Po-Sheng', 'Initials': 'PS', 'LastName': 'Chang', 'Affiliation': 'Department of Nutrition, Chung Shan Medical University, Taichung 402367, Taiwan.'}, {'ForeName': 'Hung-Wun', 'Initials': 'HW', 'LastName': 'Chen', 'Affiliation': 'Department of Nutrition, Chung Shan Medical University, Taichung 402367, Taiwan.'}, {'ForeName': 'Po-Fu', 'Initials': 'PF', 'LastName': 'Lee', 'Affiliation': 'Department of Physical Education, Fu Jen Catholic University, New Taipei City 242304, Taiwan.'}, {'ForeName': 'Yun-Chi', 'Initials': 'YC', 'LastName': 'Chang', 'Affiliation': 'Department of Physical Education, Fu Jen Catholic University, New Taipei City 242304, Taiwan.'}, {'ForeName': 'Ching-Yu', 'Initials': 'CY', 'LastName': 'Tseng', 'Affiliation': 'Department of Physical Education, Fu Jen Catholic University, New Taipei City 242304, Taiwan.'}, {'ForeName': 'Ping-Ting', 'Initials': 'PT', 'LastName': 'Lin', 'Affiliation': 'Department of Nutrition, Chung Shan Medical University, Taichung 402367, Taiwan.'}]","Antioxidants (Basel, Switzerland)",['10.3390/antiox9090823']
2647,32898435,"Power, Lesion Size Index and Oesophageal Temperature Alerts During Atrial Fibrillation Ablation: A Randomized Study.","BACKGROUND


Low radiofrequency powers are commonly used on the posterior wall of the left atrium for atrial fibrillation ablation to prevent esophageal damage. Compared with higher powers, they require longer ablation durations to achieve a target lesion size index (LSI). Esophageal heating during ablation is the result of a time-dependent process of conductive heating produced by nearby radiofrequency delivery. This randomized study was conducted to compare risk of esophageal heating and acute procedure success of different LSI-guided ablation protocols combining higher or lower radiofrequency power and different target LSI values.
METHODS


Eighty consecutive patients were prospectively enrolled and randomized to one of 4 combinations of radiofrequency power and target LSI for ablation on the left atrium posterior wall (20 W/LSI 4, 20 W/LSI 5, 40 W/LSI 4, and 40 W/LSI 5). The primary end point of the study was the occurrence and number of esophageal temperature alerts per patient during ablation. Acute indicators of procedure success were considered as secondary end points. Long-term follow-up data were also collected for all patients.
RESULTS


Esophageal temperature alerts occurred in a similar proportion of patients in all groups. Significantly, shorter radiofrequency durations were required to achieve the target LSI in the 40 W groups. Less than 50% of the radiofrequency lesions reached the target LSI of 5 when using 20 W despite a longer radiofrequency duration. A lower rate of first-pass pulmonary vein isolation and a higher rate of acute pulmonary vein reconnection were recorded in the group 20 W/LSI 5. A lower atrial fibrillation recurrence rate was observed in the 40 W groups compared with the 20 W groups at 29 months follow-up.
CONCLUSIONS


When guided by LSI, posterior wall ablation with 40 W is associated with a similar rate of esophageal temperature alerts and a lower atrial fibrillation recurrence rate at follow-up if compared with 20 W. These data will provide a basis to plan future randomized trials. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02619396.",2020,A lower rate of first-pass Pulmonary Vein Isolation and a higher rate of acute Pulmonary Vein Reconnection were recorded in the group 20W/LSI 5.,['Methods  - Eighty consecutive patients'],"['RF power and target LSI for ablation on the LA posterior wall (20W/LSI 4, 20W/LSI 5, 40W', 'LSI-guided ablation protocols', '  - Low radiofrequency (RF) powers']","['acute Pulmonary Vein Reconnection', 'AF recurrence rate', 'RF durations', 'Power, Lesion Size Index and Oesophageal Temperature Alerts during Atrial Fibrillation Ablation', 'occurrence and number of esophageal temperature alerts (ETAs) per patient during ablation']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C3854375', 'cui_str': 'Laser speckle contrast imaging'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0227701', 'cui_str': 'Structure of posterior wall of urinary bladder'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0205251', 'cui_str': 'Low'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0034090', 'cui_str': 'Structure of vein of pulmonary circulation'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0449453', 'cui_str': 'Lesion size'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",80.0,0.0762474,A lower rate of first-pass Pulmonary Vein Isolation and a higher rate of acute Pulmonary Vein Reconnection were recorded in the group 20W/LSI 5.,"[{'ForeName': 'Milena', 'Initials': 'M', 'LastName': 'Leo', 'Affiliation': 'John Radcliffe Hospital, Oxford University Hospitals Foundation Trust (M.L., M.P., K.R., M.R.G., Y.B., T.R.B.).'}, {'ForeName': 'Michala', 'Initials': 'M', 'LastName': 'Pedersen', 'Affiliation': 'John Radcliffe Hospital, Oxford University Hospitals Foundation Trust (M.L., M.P., K.R., M.R.G., Y.B., T.R.B.).'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Rajappan', 'Affiliation': 'John Radcliffe Hospital, Oxford University Hospitals Foundation Trust (M.L., M.P., K.R., M.R.G., Y.B., T.R.B.).'}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Ginks', 'Affiliation': 'John Radcliffe Hospital, Oxford University Hospitals Foundation Trust (M.L., M.P., K.R., M.R.G., Y.B., T.R.B.).'}, {'ForeName': 'Ross J', 'Initials': 'RJ', 'LastName': 'Hunter', 'Affiliation': 'Barts Heart Centre, London (R.J.H.).'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Bowers', 'Affiliation': 'Hampshire Hospitals NHS Foundation Trust (R.B.).'}, {'ForeName': 'Manish', 'Initials': 'M', 'LastName': 'Kalla', 'Affiliation': 'Queen Elisabeth Hospital, Birmingham, United Kingdom (M.K.).'}, {'ForeName': 'Yaver', 'Initials': 'Y', 'LastName': 'Bashir', 'Affiliation': 'John Radcliffe Hospital, Oxford University Hospitals Foundation Trust (M.L., M.P., K.R., M.R.G., Y.B., T.R.B.).'}, {'ForeName': 'Timothy R', 'Initials': 'TR', 'LastName': 'Betts', 'Affiliation': 'John Radcliffe Hospital, Oxford University Hospitals Foundation Trust (M.L., M.P., K.R., M.R.G., Y.B., T.R.B.).'}]",Circulation. Arrhythmia and electrophysiology,['10.1161/CIRCEP.120.008316']
2648,32910531,Tofacitinib in Patients With Psoriatic Arthritis and Metabolic Syndrome: A Post hoc Analysis of Phase 3 Studies.,"OBJECTIVE


Metabolic syndrome (MetS) is a cluster of concurrent risk factors for cardiovascular disease and type 2 diabetes. This post hoc analysis explored key efficacy and safety endpoints in patients with psoriatic arthritis (PsA) and MetS treated with tofacitinib.
METHODS


Tofacitinib 5 and 10 mg twice daily and placebo data were pooled from two Phase 3 studies (OPAL Broaden [12 months; ClinicalTrials.gov identifier NCT01877668]; OPAL Beyond [6 months; ClinicalTrials.gov identifier NCT01882439]); patients received one background conventional synthetic disease-modifying antirheumatic drug. Patients were stratified by baseline presence/absence of MetS. Efficacy and safety were reported to month 3 (tofacitinib and placebo) and 6 (tofacitinib only). Efficacy outcomes included: American College of Rheumatology (ACR)20/50/70, Health Assessment Questionnaire-Disability Index (HAQ-DI) response, Psoriasis Area Severity Index (PASI)75 response, and enthesitis/dactylitis resolution rates; and changes from baseline (Δ) in C-reactive protein, HAQ-DI, Patient's/Physician's Global Assessment of Arthritis, and patient-reported outcomes. Safety outcomes included treatment-emergent all-causality adverse events (AEs), Δ in lipid/hepatic values, and liver parameter increases.
RESULTS


Of 710 patients, 41.4% (n = 294) had baseline MetS. All efficacy outcomes improved with both tofacitinib doses versus placebo, to month 3; tofacitinib efficacy was consistent to month 6, regardless of MetS status. MetS did not appear to affect the incidence of AEs or Δ in lipid/hepatic values with tofacitinib up to month 3 or 6. Arterial thromboembolism and myocardial infarction (adjudicated major adverse cardiovascular events) were each reported once in tofacitinib-treated patients with MetS.
CONCLUSION


Regardless of baseline MetS status, tofacitinib showed greater efficacy versus placebo in patients with active PsA. The tofacitinib safety profile appeared similar in patients with versus without MetS.",2020,MetS did not appear to affect the incidence of AEs or Δ in lipid/hepatic values with tofacitinib up to month 3 or 6.,"['patients with psoriatic arthritis (PsA) and MetS treated with tofacitinib', 'patients with versus without MetS', 'Of 710 patients, 41.4% (n = 294) had baseline MetS', 'patients with active PsA', 'Patients With Psoriatic Arthritis and Metabolic Syndrome']","['placebo', 'Tofacitinib 5 and 10 mg twice daily and placebo', 'background conventional synthetic disease-modifying antirheumatic drug', 'Tofacitinib']","['Arterial thromboembolism and myocardial infarction', ""American College of Rheumatology (ACR)20/50/70, Health Assessment Questionnaire-Disability Index (HAQ-DI) response, Psoriasis Area Severity Index (PASI)75 response, and enthesitis/dactylitis resolution rates; and changes from baseline (Δ) in C-reactive protein, HAQ-DI, Patient's/Physician's Global Assessment of Arthritis, and patient-reported outcomes"", 'tofacitinib safety profile', 'Safety outcomes included treatment-emergent all-causality adverse events (AEs), Δ in lipid/hepatic values, and liver parameter increases']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic arthritis'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C2930696', 'cui_str': 'tofacitinib'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2930696', 'cui_str': 'tofacitinib'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0242708', 'cui_str': 'Disease-Modifying Antirheumatic Drugs'}]","[{'cui': 'C3544094', 'cui_str': 'Arterial thromboembolism'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0451208', 'cui_str': 'Health assessment questionnaire'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C4324362', 'cui_str': 'Psoriasis area severity index'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C1282952', 'cui_str': 'Enthesitis'}, {'cui': 'C0239161', 'cui_str': 'Dactylitis'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0003864', 'cui_str': 'Arthritis'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C2930696', 'cui_str': 'tofacitinib'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",710.0,0.457719,MetS did not appear to affect the incidence of AEs or Δ in lipid/hepatic values with tofacitinib up to month 3 or 6.,"[{'ForeName': 'Christopher T', 'Initials': 'CT', 'LastName': 'Ritchlin', 'Affiliation': 'University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Jon T', 'Initials': 'JT', 'LastName': 'Giles', 'Affiliation': 'Columbia University, New York, New York.'}, {'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Ogdie', 'Affiliation': 'Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Juan J', 'Initials': 'JJ', 'LastName': 'Gomez-Reino', 'Affiliation': 'Hospital Clínico Universitario, Santiago de Compostela, Spain.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Helliwell', 'Affiliation': 'Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Young', 'Affiliation': 'Pfizer Inc, Collegeville, Pennsylvania.'}, {'ForeName': 'Cunshan', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Pfizer Inc, Groton, Connecticut.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Pfizer Inc, Groton, Connecticut.'}, {'ForeName': 'Ana Belén', 'Initials': 'AB', 'LastName': 'Romero', 'Affiliation': 'Pfizer Inc, Barcelona, Spain.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Woolcott', 'Affiliation': 'Pfizer Inc, Collegeville, Pennsylvania.'}, {'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Stockert', 'Affiliation': 'Pfizer Inc, Collegeville, Pennsylvania.'}]",ACR open rheumatology,['10.1002/acr2.11166']
2649,32911306,Long-term safety and efficacy of teriflunomide in patients with relapsing multiple sclerosis: Results from the TOWER extension study.,"BACKGROUND


In the phase 3 TOWER core study (NCT00751881), the efficacy and safety of teriflunomide compared with placebo were demonstrated in patients with relapsing forms of multiple sclerosis (RMS). Here, the long-term safety and efficacy outcomes from the TOWER extension study (NCT00751881) are reported.
METHODS


All patients who entered the extension (N = 751) were assigned to teriflunomide 14 mg and assessed for long-term safety and efficacy.
RESULTS


Of 751 patients in the TOWER extension study, 253, 265, and 233 patients received placebo/teriflunomide 14 mg, teriflunomide 7 mg/14 mg, and teriflunomide 14 mg/14 mg, respectively. Median teriflunomide exposure was 4.25 years (maximum 6.3 years). The overall frequency of adverse events (AEs) was comparable across treatment groups, but a higher proportion of patients in the teriflunomide 7 mg/14 mg (12.4%) and 14 mg/14 mg (12.4%) groups had serious AEs compared with the placebo/teriflunomide 14 mg group (6.4%). Alanine aminotransferase increase and hair thinning occurred at a higher frequency in the placebo/teriflunomide 14 mg group (11.2% and 14.3%, respectively) compared with the teriflunomide 7 mg/14 mg (3.0% and 4.5%, respectively) and 14 mg/14 mg groups (5.2% and 4.3%, respectively). The incidences of AEs of interest (hematologic and hepatic effects, peripheral neuropathy, hypertension, and malignancy) were low and comparable across treatment arms. Disability worsening and adjusted annualized relapse rates were low and stable over time, and mean Expanded Disability Status Scale scores were unchanged over time, for all treatment groups.
CONCLUSION


In the TOWER extension study, the efficacy of teriflunomide 14 mg was maintained in patients with RMS. No new or unexpected AEs were observed with teriflunomide treatment, supporting a safety profile in the extension that was consistent with the core trial. These findings support the positive benefit:risk profile of teriflunomide as a long-term immunomodulatory therapy.",2020,"Alanine aminotransferase increase and hair thinning occurred at a higher frequency in the placebo/teriflunomide 14 mg group (11.2% and 14.3%, respectively) compared with the teriflunomide 7 mg/14 mg (3.0% and 4.5%, respectively) and 14 mg/14 mg groups (5.2% and 4.3%, respectively).","['All patients who entered the extension', '751 patients in the TOWER extension study, 253, 265, and 233 patients received', 'patients with relapsing forms of multiple sclerosis (RMS', 'patients with relapsing multiple sclerosis', 'patients with RMS']","['placebo/teriflunomide 14\xa0mg, teriflunomide', 'placebo', 'placebo/teriflunomide', 'teriflunomide']","['incidences of AEs of interest (hematologic and hepatic effects, peripheral neuropathy, hypertension, and malignancy', 'efficacy and safety', 'Disability worsening and adjusted annualized relapse rates', 'Median teriflunomide exposure', 'mean Expanded Disability Status Scale scores', 'Alanine aminotransferase increase and hair thinning', 'overall frequency of adverse events (AEs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0856120', 'cui_str': 'Multiple sclerosis relapse'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3497716', 'cui_str': 'teriflunomide 14 MG'}, {'cui': 'C1718383', 'cui_str': 'teriflunomide'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0018943', 'cui_str': 'Hematology'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C1869037', 'cui_str': 'Peripheral neuropathy (SMQ)'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1718383', 'cui_str': 'teriflunomide'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0151905', 'cui_str': 'Alanine aminotransferase increased'}, {'cui': 'C0020678', 'cui_str': 'Hypotrichosis'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",751.0,0.0571361,"Alanine aminotransferase increase and hair thinning occurred at a higher frequency in the placebo/teriflunomide 14 mg group (11.2% and 14.3%, respectively) compared with the teriflunomide 7 mg/14 mg (3.0% and 4.5%, respectively) and 14 mg/14 mg groups (5.2% and 4.3%, respectively).","[{'ForeName': 'Aaron E', 'Initials': 'AE', 'LastName': 'Miller', 'Affiliation': 'Department of Neurology, Icahn School of Medicine at Mount Sinai, 5 East 98th Street-Box 1138, New York, NY, 10029, United States. Electronic address: aaron.miller@mssm.edu.'}, {'ForeName': 'Tomas P', 'Initials': 'TP', 'LastName': 'Olsson', 'Affiliation': 'Neuroimmunology Unit, Department of Clinical Neuroscience, Karolinska Institutet, Center for Molecular Medicine, L8:04, Karolinska Hospital, 17176 Stockholm, Sweden.'}, {'ForeName': 'Jerry S', 'Initials': 'JS', 'LastName': 'Wolinsky', 'Affiliation': 'Department of Neurology, McGovern Medical School, The University of Texas Health Science Center at Houston (UTHealth), 6431 Fannin Street, Houston, TX, 77030, United States.'}, {'ForeName': 'Giancarlo', 'Initials': 'G', 'LastName': 'Comi', 'Affiliation': 'Ospedale San Raffaele, Milan, Italy.'}, {'ForeName': 'Ludwig', 'Initials': 'L', 'LastName': 'Kappos', 'Affiliation': 'Neurologic Clinic and Policlinic, Departments of Medicine, Clinical Research and Biomedical Engineering, University Hospital and University of Basel, Petersgraben 4, CH-4031 Basel, Switzerland.'}, {'ForeName': 'Xueqiang', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'Neurology, Hospital of Sun Yat-Sen University, 107 Yan Jiang West Road, Guangzhou, China.'}, {'ForeName': 'Xianhao', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Beijing Hospital, No. 1 Dahua Road, Beijing, China.'}, {'ForeName': 'Alex L', 'Initials': 'AL', 'LastName': 'Lublin', 'Affiliation': 'Sanofi, Cambridge, MA, United States.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Truffinet', 'Affiliation': 'Sanofi, Chilly-Mazarin, France.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Chavin', 'Affiliation': 'Sanofi, Cambridge, MA, United States.'}, {'ForeName': 'Jean-Luc', 'Initials': 'JL', 'LastName': 'Delhay', 'Affiliation': 'Sanofi, Chilly-Mazarin, France.'}, {'ForeName': 'Myriam', 'Initials': 'M', 'LastName': 'Benamor', 'Affiliation': 'Sanofi, Chilly-Mazarin, France.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Purvis', 'Affiliation': 'Sanofi, Cambridge, MA, United States.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Freedman', 'Affiliation': 'The Ottawa Hospital Ontario, 501 Smyth Road, Box 601, Ottawa, ON, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2020.102438']
2650,32911319,"A randomized pilot study assessing the acceptability of rapid point-of-care hepatitis C virus (HCV) testing among male inmates in Montreal, Canada.","BACKGROUND


The Oraquick Ⓡ  fingerprick point-of-care hepatitis C virus antibody (HCV-Ab) test is favoured to venipuncture among people who inject drugs; however, its acceptability in prison populations is unknown. We aimed to compare the acceptability of the Oraquick Ⓡ  versus standard venipuncture among people in prison.
METHODS


From October to December 2019, 280 sentenced male inmates at L'Établissement de Détention de Montréal (Quebec, Canada) were screened for participation, 150 excluded due to prior HCV screening, and 52 refused participation. The remaining 78 were randomized 1:1 to opt-out HCV-Ab screening with OraQuick Ⓡ  or venipuncture (n = 39 each). Acceptability was determined by the proportion accepting to undergo screening.
RESULTS


The majority of participants (median age 33 years) reported a history of drug use (76%; 8% injection drug use); 47% perceived their HCV risk to be moderate/high. All inmates randomized to Oraquick Ⓡ  accepted testing while 87% accepted venipuncture. Among those who accepted Oraquick Ⓡ  vs. venipuncture, 100% vs. 97% were satisfied with the test, 97% vs. 94% would recommend the same test, and 100% vs. 76% would choose the same test again.
CONCLUSION


Adult incarcerated men in Canada were both more likely to accept Oraquick Ⓡ  compared to venipuncture, and to choose Oraquick Ⓡ  for future HCV screening.",2020,"CONCLUSION


Adult incarcerated men in Canada were both more likely to accept Oraquick Ⓡ  compared to venipuncture, and to choose Oraquick Ⓡ  for future HCV screening.","[""From October to December 2019, 280 sentenced male inmates at L'Établissement de Détention de Montréal (Quebec, Canada) were screened for participation, 150 excluded due to prior HCV screening, and 52 refused participation"", 'people in prison', 'male inmates in Montreal, Canada', 'Adult incarcerated men in Canada']","['rapid point-of-care hepatitis C virus (HCV', 'venipuncture', 'Ⓡ  or venipuncture', 'HCV-Ab screening with OraQuick', 'Oraquick Ⓡ  versus standard venipuncture']",['Acceptability'],"[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0033167', 'cui_str': 'Prisoners'}, {'cui': 'C0034390', 'cui_str': 'Quebec'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0019196', 'cui_str': 'Viral hepatitis C'}, {'cui': 'C0017095', 'cui_str': 'Trash'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0392751', 'cui_str': 'In prison'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0282664', 'cui_str': 'Point-of-Care'}, {'cui': 'C0079500', 'cui_str': 'Hepacivirus'}, {'cui': 'C0019196', 'cui_str': 'Viral hepatitis C'}, {'cui': 'C0190979', 'cui_str': 'Phlebotomy'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}]",280.0,0.0431789,"CONCLUSION


Adult incarcerated men in Canada were both more likely to accept Oraquick Ⓡ  compared to venipuncture, and to choose Oraquick Ⓡ  for future HCV screening.","[{'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Kronfli', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases and Chronic Viral Illness Service, McGill University, Montreal, Quebec, Canada; Research Institute of the McGill University Health Centre, Montreal, Quebec, Canada. Electronic address: nadine.kronfli@mcgill.ca.'}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Dussault', 'Affiliation': 'Research Institute of the McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Chalifoux', 'Affiliation': 'Research Institute of the McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Hasmig', 'Initials': 'H', 'LastName': 'Kavoukian', 'Affiliation': 'Research Institute of the McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Marina B', 'Initials': 'MB', 'LastName': 'Klein', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases and Chronic Viral Illness Service, McGill University, Montreal, Quebec, Canada; Research Institute of the McGill University Health Centre, Montreal, Quebec, Canada; CIHR Canadian HIV Trials Network, Vancouver, Canada.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Cox', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases and Chronic Viral Illness Service, McGill University, Montreal, Quebec, Canada; Research Institute of the McGill University Health Centre, Montreal, Quebec, Canada; Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, Quebec, Canada.'}]",The International journal on drug policy,['10.1016/j.drugpo.2020.102921']
2651,32906163,[Reduction of Visitor- and Staff-Associated Risk of Infection by Complex Intervention in the Department of Feto-Maternal Medicine].,"AIM


Clinical trial registration of this trial: is to demonstrate in a department of feto-maternal medicine: (a) that a complex intervention improves hand hygiene of visitors, siblings and staff; and (b) that automated voice prompts at disinfectant dispensers improve rate of hand disinfection.
STUDY DESIGN


(a) Pre-/post-test follow-up design with control (1-12/2016), intervention (1-12/2017), follow-up-period (1/2018-12/2019); and (b) RCT in quasi crossover design. Primary endpoints: (a) disinfectant consumption (DC) per patient-day, and (b) DC at disinfectant dispenser per passer-by.
RESULTS


A multimodal strategy within the intervention period showed a relevant positive effect on hand hygiene compliance (in IP: 26.2% more DC; p=0.088). Voice prompts increased DC by 28.6% (p=0.025). The odds ratio for high positive fingertip testing plates of visiting children (siblings) between control and intervention period was 0.35 (95% CI [0.1074-0.9708] p=0.039).
CONCLUSION


Complex intervention and electronic voice prompts on disinfectant dispensers improve hand hygiene behaviour in perinatology. Installation of disinfectant dispensers in a child-friendly position and adequate information material appeal to children. The data represent an important contribution to improve hand hygiene of visitors, siblings and staff in hospitals in a pandemic situation.",2020,Voice prompts increased DC by 28.6% (p=0.025).,['perinatology'],['complex intervention'],"['Visitor- and Staff', 'hand hygiene compliance', 'disinfectant consumption (DC) per patient-day, and (b) DC at disinfectant dispenser per passer-by', 'rate of hand disinfection']","[{'cui': 'C0031063', 'cui_str': 'Perinatology'}]","[{'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C3494474', 'cui_str': 'Hand Hygiene'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0012682', 'cui_str': 'Disinfectant'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0180463', 'cui_str': 'Dispenser'}, {'cui': 'C0999347', 'cui_str': 'Passer'}, {'cui': 'C0018570', 'cui_str': 'Disinfection, Hand'}]",,0.094279,Voice prompts increased DC by 28.6% (p=0.025).,"[{'ForeName': 'Gregor', 'Initials': 'G', 'LastName': 'Seliger', 'Affiliation': 'Universitätsklinik und Poliklinik für Geburtshilfe und Pränatalmedizin, Martin-Luther-Universität Halle-Wittenberg, Halle.'}, {'ForeName': 'Inna', 'Initials': 'I', 'LastName': 'Krol', 'Affiliation': 'Universitätsklinik und Poliklinik für Geburtshilfe und Pränatalmedizin, Martin-Luther-Universität Halle-Wittenberg, Halle.'}, {'ForeName': 'Dieter', 'Initials': 'D', 'LastName': 'Worlitzsch', 'Affiliation': 'Universitätsklinikum/Stabsstelle Krankenhaushygiene, Martin-Luther-Universität Halle-Wittenberg, Halle.'}, {'ForeName': 'Eva Johanna', 'Initials': 'EJ', 'LastName': 'Kantelhardt', 'Affiliation': 'Institut für Medizinische Epidemiologie, Biometrie und Informatik, Martin-Luther-Universität Halle-Wittenberg, Halle.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Moritz', 'Affiliation': 'Medizincontrolling/Sachgebiet Klinische Infektologie, Universitätsklinikum Halle (Saale), Martin-Luther-Universität Halle-Wittenberg, Halle.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Tchirikov', 'Affiliation': 'Universitätsklinik und Poliklinik für Geburtshilfe und Pränatalmedizin, Martin-Luther-Universität Halle-Wittenberg, Halle.'}]",Zeitschrift fur Geburtshilfe und Neonatologie,['10.1055/a-1226-7257']
2652,32911530,Association of strength and plyometric exercises with change of direction performances.,"The change of direction (COD) ability is an important task-specific skill for success in team sports, dependent on both strength and reactive strength. The sprint approaching the COD and degrees of the turn are factors influencing the specificity of the COD. Thus, CODs have been suggested to be categorized as force- (> 90°) and velocity-dominant (< 90°) dependent on the degree of the turn. When training programmes fail to provide a significant increase in COD performance, it is often due to neglecting the task-specific demands of the COD. As such, 23 male football players volunteered to complete a randomized controlled trial, investigating the association of maximal strength and power performance with performance in a force- (180°) and velocity-dominant (45°) COD, with a 4 m and 20 m sprint approach. Three strength and three plyometric exercises, matched in movement patterns, were used. Muscle activity of the different conditions was also compared. The correlational analysis revealed that better performance in the plyometric tests were associated with less time to complete both force- and velocity-dominant CODs, supported by similarities in muscle activation. None of the performances in strength exercises correlated to COD performance, due to the slow contraction velocity of maximal lifts. It was concluded that plyometrics share more physical similarities with CODs than the strength exercises.",2020,"The correlational analysis revealed that better performance in the plyometric tests were associated with less time to complete both force- and velocity-dominant CODs, supported by similarities in muscle activation.",['23 male football players volunteered'],"['strength and plyometric exercises', 'force- (180°) and velocity-dominant (45°) COD, with a 4 m and 20 m sprint approach']","['slow contraction velocity of maximal lifts', 'Muscle activity', 'COD performance', 'change of direction (COD) ability']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0016517', 'cui_str': 'American or Canadian football - sport'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C3178799', 'cui_str': 'Plyometric Drill'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0439755', 'cui_str': 'Directions'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0181620', 'cui_str': 'Hoist'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0439755', 'cui_str': 'Directions'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",23.0,0.0286141,"The correlational analysis revealed that better performance in the plyometric tests were associated with less time to complete both force- and velocity-dominant CODs, supported by similarities in muscle activation.","[{'ForeName': 'Hallvard Nygaard', 'Initials': 'HN', 'LastName': 'Falch', 'Affiliation': 'Department of Sport Science and Physical Education, Nord University, Levanger, Norway.'}, {'ForeName': 'Håvard Guldteig', 'Initials': 'HG', 'LastName': 'Rædergård', 'Affiliation': 'Department of Sport Science and Physical Education, Nord University, Levanger, Norway.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'van den Tillaar', 'Affiliation': 'Department of Sport Science and Physical Education, Nord University, Levanger, Norway.'}]",PloS one,['10.1371/journal.pone.0238580']
2653,32911680,Metabonomic Responses of Grazing Yak to Different Concentrate Supplementations in Cold Season.,"Supplementation plays an important role in reversing the weight loss of grazing yaks during cold season. However, little is known about the effect of supplementation on the serum metabolites of grazing yaks. The objective of this study was to explore the effects of supplementary feeding on average daily gain (ADG) and serum metabolites with nuclear magnetic resonance (NMR)-based metabolomics method in growing yaks during cold season on the Qinghai-Tibetan plateau. Twenty 1.5-year-old female yaks (91.38 ± 10.43 kg LW) were evenly divided into three treatment groups and a control group (CON) ( n  = 5 per group). All the yaks were released to graze during daytime, whereas the yaks in the treatment groups were supplemented with highland barley (HLB), rapeseed meal (RSM), and highland barley plus rapeseed meal (HLB + RSM) at night. The whole experiment lasted for 120 days. Results indicated that the ADG of growing yak heifers was increased by concentrate supplementations, and ADG under HLB and HLB + RSM group was 37.5% higher ( p  < 0.05) than that with RSM supplementation. Supplementary feeding increased the plasma concentrations of total protein (TP), albumin (ALB), and blood urea nitrogen (BUN) of those in the CON group, and concentrations of BUN were higher in the RSM group than in the HLB and HLB + RSM group. Compared with the CON group, serum levels of glutamine, glycine, β-glucose were lower and that of choline was higher in the HLB group; serum levels of lactate were lower and that of choline, glutamate were higher in the HLB + RSM group. Compared with the HLB + RSM group, serum levels of glycerophosphoryl choline (GPC) and lactate were higher, and those of choline, glutamine, glutamate, leucine,  N -acetyaspartate, α-glucose, and β-glucose were lower in the HLB group; serum levels of citrate, GPC and lactate were higher, and those of 3-Hydroxybutyrate, betaine, choline, glutamate, glutamine,  N -acetylglycoprotein,  N -acetyaspartate, α-glucose, and β-glucose were lower in the RSM group. It could be concluded that concentrate supplementations significantly improved the growth performance of growing yaks and supplementation with HBL or HLB plus RSM was better than RSM during the cold season. Supplementation with HBL or HLB plus RSM affected the serum metabolites of grazing yaks, and both treatments promoted lipid synthesis. Supplementation of yaks with HBL plus RSM could improve energy-supply efficiency, protein and lipid deposition compared with HLB and RSM.",2020,"Compared with the CON group, serum levels of glutamine, glycine, β-glucose were lower and that of choline was higher in the HLB group; serum levels of lactate were lower and that of choline, glutamate were higher in the HLB + RSM group.",['Twenty 1.5-year-old female yaks (91.38 ± 10.43 kg LW'],"['RSM', 'HLB + RSM', 'HBL plus RSM', 'HBL or HLB plus RSM', 'control group (CON', 'CON', 'supplementary feeding', 'highland barley (HLB), rapeseed meal (RSM), and highland barley plus rapeseed meal (HLB + RSM']","['average daily gain (ADG) and serum metabolites', 'serum metabolites of grazing yaks', 'growth performance', '3-Hydroxybutyrate, betaine, choline, glutamate, glutamine,  N -acetylglycoprotein,  N -acetyaspartate, α-glucose, and β-glucose', 'concentrations of BUN', 'serum levels of glycerophosphoryl choline (GPC) and lactate', 'choline, glutamine, glutamate, leucine,  N -acetyaspartate, α-glucose, and β-glucose', 'serum levels of lactate', 'serum levels of citrate, GPC and lactate', 'energy-supply efficiency, protein and lipid deposition', 'serum levels of glutamine, glycine, β-glucose', 'plasma concentrations of total protein (TP), albumin (ALB), and blood urea nitrogen (BUN', 'lipid synthesis']","[{'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0325253', 'cui_str': 'Bos grunniens'}]","[{'cui': 'C0206624', 'cui_str': 'Hepatoblastoma'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038847', 'cui_str': 'Complementary Feeding'}, {'cui': 'C0454911', 'cui_str': 'Highland'}, {'cui': 'C0004755', 'cui_str': 'Hordeum'}, {'cui': 'C0034670', 'cui_str': 'Brassica rapa'}, {'cui': 'C1998602', 'cui_str': 'Meals'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0325253', 'cui_str': 'Bos grunniens'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0106006', 'cui_str': '3-hydroxybutyrate'}, {'cui': 'C0005304', 'cui_str': 'Betaine'}, {'cui': 'C0008405', 'cui_str': 'Choline'}, {'cui': 'C0017789', 'cui_str': 'Glutamates'}, {'cui': 'C0017797', 'cui_str': 'Glutamine'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005845', 'cui_str': 'Blood urea nitrogen measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0023401', 'cui_str': 'Leucine'}, {'cui': 'C0008857', 'cui_str': 'Citrates'}, {'cui': 'C1415375', 'cui_str': 'Glycophorin D'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0333574', 'cui_str': 'Fatty deposition'}, {'cui': 'C0017890', 'cui_str': 'Glycine'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0555903', 'cui_str': 'Total protein measurement'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C1563744', 'cui_str': 'Lipogenesis'}]",,0.0214806,"Compared with the CON group, serum levels of glutamine, glycine, β-glucose were lower and that of choline was higher in the HLB group; serum levels of lactate were lower and that of choline, glutamate were higher in the HLB + RSM group.","[{'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Animal Nutrition Institute, Sichuan Agricultural University, Chengdu 611130, China.'}, {'ForeName': 'Shuangming', 'Initials': 'S', 'LastName': 'Yue', 'Affiliation': 'Animal Nutrition Institute, Sichuan Agricultural University, Chengdu 611130, China.'}, {'ForeName': 'Quanhui', 'Initials': 'Q', 'LastName': 'Peng', 'Affiliation': 'Animal Nutrition Institute, Sichuan Agricultural University, Chengdu 611130, China.'}, {'ForeName': 'Lizhi', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Animal Nutrition Institute, Sichuan Agricultural University, Chengdu 611130, China.'}, {'ForeName': 'Zhisheng', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Animal Nutrition Institute, Sichuan Agricultural University, Chengdu 611130, China.'}, {'ForeName': 'Bai', 'Initials': 'B', 'LastName': 'Xue', 'Affiliation': 'Animal Nutrition Institute, Sichuan Agricultural University, Chengdu 611130, China.'}]",Animals : an open access journal from MDPI,['10.3390/ani10091595']
2654,32911776,Communicating Evidence about the Causes of Obesity and Support for Obesity Policies: Two Population-Based Survey Experiments.,"Public support for numerous obesity policies is low, which is one barrier to their implementation. One reason for this low support is the tendency to ascribe obesity to failings of willpower as opposed to the environment. Correlational evidence supports this position. However, the experimental evidence is mixed. In two experimental studies, participants were randomised to receive no message, messages about the environment's influence on obesity (Study 1 & 2), or messages about the environment's influence on human behaviour (Study 1). We investigated whether communicating these messages changed support for obesity policies and beliefs about the causes of obesity. Participants were recruited from nationally representative samples in Great Britain (Study 1 & 2) and the USA (Study 2) (total  n  = 4391). Study 2 was designed to replicate existing research. Neither study found evidence that communicating the messages increased support for obesity policies or strengthened beliefs about the environment's role in obesity. Study 2, therefore, did not replicate two earlier experimental studies. Instead, the studies reported here suggest that people's beliefs about the causes of obesity are resistant to change in response to evidence and are, therefore, not a promising avenue to increase support for obesity policies.",2020,Neither study found evidence that communicating the messages increased support for obesity policies or strengthened beliefs about the environment's role in obesity.,['Participants were recruited from nationally representative samples in Great Britain (Study 1 & 2) and the USA (Study 2) (total  n  = 4391'],[],[],"[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0018223', 'cui_str': 'Great Britain'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",[],[],,0.0341881,Neither study found evidence that communicating the messages increased support for obesity policies or strengthened beliefs about the environment's role in obesity.,"[{'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Reynolds', 'Affiliation': 'Behaviour and Health Research Unit, University of Cambridge, Cambridge CB2 0SR, UK.'}, {'ForeName': 'Milica', 'Initials': 'M', 'LastName': 'Vasiljevic', 'Affiliation': 'Behaviour and Health Research Unit, University of Cambridge, Cambridge CB2 0SR, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Pilling', 'Affiliation': 'Behaviour and Health Research Unit, University of Cambridge, Cambridge CB2 0SR, UK.'}, {'ForeName': 'Marissa G', 'Initials': 'MG', 'LastName': 'Hall', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC 27514, USA.'}, {'ForeName': 'Kurt M', 'Initials': 'KM', 'LastName': 'Ribisl', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC 27514, USA.'}, {'ForeName': 'Theresa M', 'Initials': 'TM', 'LastName': 'Marteau', 'Affiliation': 'Behaviour and Health Research Unit, University of Cambridge, Cambridge CB2 0SR, UK.'}]",International journal of environmental research and public health,['10.3390/ijerph17186539']
2655,32887707,Improved Time in Range Over 1 Year Is Associated With Reduced Albuminuria in Individuals With Sensor-Augmented Insulin Pump-Treated Type 1 Diabetes.,"OBJECTIVE


To investigate the association between treatment-induced change in continuous glucose monitoring (CGM) time in range (TIR) and albuminuria in persons with type 1 diabetes (T1D) treated with sensor-augmented insulin pumps (SAP).
RESEARCH DESIGN AND METHODS


Twenty-six out of 55 participants with albuminuria and multiple daily injection therapy (25% females; median 51 [interquartile range 46-63] years of age; glycated hemoglobin A 1c  (HbA 1c ) 75 [68-88] mmol/mol [9.0% (8.4-10.4%)]; and urinary albumin-to-creatinine ratio (UACR) 89 [37-250] mg/g) were in a randomized controlled trial assigned to SAP therapy for 1 year. Anthropometrics, CGM data, and blood and urine samples were collected every 3 months.
RESULTS


Mean change (95% CI) in percentage of TIR (%TIR) was 13.2% (6.2; 20.2), in HbA 1c  was -14.4 (-17.4; -10.5) mmol/mol (-1.3% [-1.6; -1.0]), and in UACR was -15% (-38; 17) (all  P  < 0.05). UACR decreased by 19% (10; 28) per 10% increase in %TIR ( P  = 0.04), 18% (1; 30) per 10 mmol/mol decrease in HbA 1c  ( P  = 0.07), and 31% per 10-mmHg decrease in mean arterial pressure ( P  < 0.001).
CONCLUSIONS


In this longitudinal study, treatment-induced increase in %TIR was significantly associated with decrease in albuminuria in T1D.",2020,"UACR decreased by 19% (10; 28) per 10% increase in %TIR ( P  = 0.04), 18% (1; 30) per 10 mmol/mol decrease in HbA 1c  ( P  = 0.07), and 31% per 10-mmHg decrease in mean arterial pressure ( P  < 0.001).
","['Twenty-six out of 55 participants with albuminuria and multiple daily injection therapy (25% females; 51 [46-63] years of age; glycated hemoglobin A 1c  (HbA 1c ) 75 [68-88] mmol/mol [9.0% (8.4-10.4%)]; and urinary albumin-to-creatinine ratio (UACR) 89 [37-250] mg/g', 'persons with type 1 diabetes (T1D) treated with sensor-augmented insulin pumps (SAP']",['SAP therapy'],"['percentage of TIR', 'continuous glucose monitoring (CGM) time in range (TIR) and albuminuria', 'UACR', 'Anthropometrics, CGM data, and blood and urine samples', 'albuminuria in T1D', 'mean arterial pressure']","[{'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}, {'cui': 'C4517876', 'cui_str': '8.4'}, {'cui': 'C5191376', 'cui_str': '10.4'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C1300563', 'cui_str': 'g/kg'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C1140609', 'cui_str': 'Insulin pump'}]","[{'cui': 'C0183210', 'cui_str': 'Sensor device'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C1140609', 'cui_str': 'Insulin pump'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0460094', 'cui_str': 'Within reference range'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C1610733', 'cui_str': 'Urine specimen'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}]",55.0,0.0377374,"UACR decreased by 19% (10; 28) per 10% increase in %TIR ( P  = 0.04), 18% (1; 30) per 10 mmol/mol decrease in HbA 1c  ( P  = 0.07), and 31% per 10-mmHg decrease in mean arterial pressure ( P  < 0.001).
","[{'ForeName': 'Ajenthen G', 'Initials': 'AG', 'LastName': 'Ranjan', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark ajenthen.ranjan@regionh.dk.'}, {'ForeName': 'Signe V', 'Initials': 'SV', 'LastName': 'Rosenlund', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Tine W', 'Initials': 'TW', 'LastName': 'Hansen', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Rossing', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Steen', 'Initials': 'S', 'LastName': 'Andersen', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Nørgaard', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}]",Diabetes care,['10.2337/dc20-0909']
2656,32889373,Benefit-harm balance of fingolimod in patients with MS: A modelling study based on FREEDOMS.,"BACKGROUND


Fingolimod lowers the number of relapses in multiple sclerosis (MS) patients and slows down disease progression, but causes a broad spectrum of side effects. Our aim was to estimate the benefit-harm balance of fingolimod using individual patient data from FREEDOMS, a randomized controlled trial that compared two different dosages of fingolimod to placebo.
METHODS


We modelled the health status of patients over two years on a scale ranging from 0 (worst health or death) to 100 (maximum health). The model considered Expanded Disability Status Scale measurements, relapses and adverse events. We compared the mean health status between arms, and the proportion of trial participants for whom health declined or improved compared to baseline by a predefined minimal important difference of 4.6 or more.
RESULTS


The main analysis showed a net benefit for fingolimod 0.5mg compared to placebo, with an average health status difference over two years of 2.7 (95% CI 2.2 to 3.2). Patients on fingolimod 0.5mg were 0.53 (95% CI 0.40-0.72, p<0.001) times less likely to have a relevant decline in health status compared to patients on placebo, corresponding to a number needed to treat of 8 to prevent one relevant decline in health status. All sensitivity analyses favoured fingolimod 0.5mg.
CONCLUSION


Although fingolimod's net benefit did not reach the clinical relevance on average, the decreased risk for a decline in health over two years may be relevant. This approach could be applied to other MS drugs and provide an objective evidence base for guideline recommendations.",2020,"The main analysis showed a net benefit for fingolimod 0.5mg compared to placebo, with an average health status difference over two years of 2.7 (95% CI 2.2 to 3.2).","['patients with MS', 'patients over two years on a scale ranging from 0 (worst health or death) to 100 (maximum health']","['placebo', 'fingolimod to placebo']","['mean health status', 'Disability Status Scale measurements, relapses and adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0806909', 'cui_str': 'Max'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1699926', 'cui_str': 'fingolimod'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0681887', 'cui_str': 'Measurement scales'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.143984,"The main analysis showed a net benefit for fingolimod 0.5mg compared to placebo, with an average health status difference over two years of 2.7 (95% CI 2.2 to 3.2).","[{'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Spanu', 'Affiliation': 'Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Switzerland.'}, {'ForeName': 'Hélène E', 'Initials': 'HE', 'LastName': 'Aschmann', 'Affiliation': 'Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Switzerland.'}, {'ForeName': 'Jürg', 'Initials': 'J', 'LastName': 'Kesselring', 'Affiliation': 'RehaKliniken Valens, Zurich, Switzerland.'}, {'ForeName': 'Milo A', 'Initials': 'MA', 'LastName': 'Puhan', 'Affiliation': 'Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Switzerland. Electronic address: miloalan.puhan@uzh.ch.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2020.102464']
2657,32889413,Outcomes of individualized goal-directed therapy based on cerebral oxygen balance in high-risk patients undergoing cardiac surgery: A randomized controlled trial.,"STUDY OBJECTIVE


To investigate whether optimizing individualized goal-directed therapy (GDT) based on cerebral oxygen balance in high-risk surgical patients would reduce postoperative morbidity.
DESIGN


This was a prospective, randomized, controlled study.
SETTING


The study was performed in the First Affiliated Hospital of Anhui Medical University, Hefei, China, from April 2017 to July 2018.
PATIENTS


146 high-risk adult patients undergoing valve replacements or coronary artery bypass surgery with cardiopulmonary bypass (CPB) were enrolled.
INTERVENTION


Patients were randomized to an individualized GDT group or usual care group. Individualized GDT was targeted to achieve the following goals: A less than 20% decline in the regional cerebral oxygen saturation (rScO 2 ) level from baseline; a less than 20% decline in the mean arterial pressure (MAP) from baseline, as well as a bispectral index (BIS) of 45-60 before and after CPB and 40-45 during CPB.
MEASUREMENTS


The primary outcome was a composite endpoint of 30-day mortality and major postoperative complications.
MAIN RESULTS


128 completed the trial and were included in the modified intention-to-treat analysis. Early morbidity was similar between the GDT (25 [39%] of 65 patients) and usual care groups (33 [53%] of 63 patients) (relative risk 0.73, 95% CI 0.50-1.08; P = 0.15). Secondary analysis showed that 75 (59%) of 128 patients achieved individual targets (irrespective of intervention) and sustained less morbidity (relative risk 3.41, 95% CI 2.19-5.31; P < 0.001).
CONCLUSIONS


In high-risk patients undergoing cardiac surgery, individualized GDT therapy did not yield better outcomes, however, the achievement of preoperative individual targets may be associated with less morbidity.
TRIAL REGISTRATION


Clinicaltrials.gov identifier: NCT03103633. Registered on 1 April 2017.",2020,"Early morbidity was similar between the GDT (25 [39%] of 65 patients) and usual care groups (33 [53%] of 63 patients) (relative risk 0.73, 95% CI 0.50-1.08; P = 0.15).","['high-risk surgical patients', 'high-risk patients undergoing cardiac surgery', 'The study was performed in the First Affiliated Hospital of Anhui Medical University, Hefei, China, from April 2017 to July 2018', '146 high-risk adult patients undergoing valve replacements or coronary artery bypass surgery with cardiopulmonary bypass (CPB) were enrolled']","['individualized goal-directed therapy', 'cardiac surgery, individualized GDT therapy', 'individualized goal-directed therapy (GDT', 'individualized GDT group or usual care group']","['mean arterial pressure (MAP', 'Early morbidity', 'morbidity', 'cerebral oxygen balance', 'regional cerebral oxygen saturation (rScO 2 ) level', 'bispectral index (BIS', 'composite endpoint of 30-day mortality and major postoperative complications']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}]","[{'cui': 'C1271494', 'cui_str': 'Goal directed therapy'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C4273907', 'cui_str': 'Cerebral oxygen saturation'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1301882', 'cui_str': 'Bispectral index'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}]",,0.315518,"Early morbidity was similar between the GDT (25 [39%] of 65 patients) and usual care groups (33 [53%] of 63 patients) (relative risk 0.73, 95% CI 0.50-1.08; P = 0.15).","[{'ForeName': 'Xin-Qi', 'Initials': 'XQ', 'LastName': 'Cheng', 'Affiliation': 'Department of Anesthesiology, First Affiliated Hospital of Anhui Medical University, 230022 Hefei, China. Electronic address: ay_mz_cheng@126.com.'}, {'ForeName': 'Jun-Yan', 'Initials': 'JY', 'LastName': 'Zhang', 'Affiliation': 'Department of Pharmacology, Anhui Medical University, 230032 Hefei, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'Department of Anesthesiology, First Affiliated Hospital of Anhui Medical University, 230022 Hefei, China.'}, {'ForeName': 'You-Mei', 'Initials': 'YM', 'LastName': 'Zuo', 'Affiliation': 'Department of Anesthesiology, First Affiliated Hospital of Anhui Medical University, 230022 Hefei, China.'}, {'ForeName': 'Li-Li', 'Initials': 'LL', 'LastName': 'Tang', 'Affiliation': 'Department of Anesthesiology, First Affiliated Hospital of Anhui Medical University, 230022 Hefei, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Zhao', 'Affiliation': 'Department of Anesthesiology, First Affiliated Hospital of Anhui Medical University, 230022 Hefei, China.'}, {'ForeName': 'Er-Wei', 'Initials': 'EW', 'LastName': 'Gu', 'Affiliation': 'Department of Anesthesiology, First Affiliated Hospital of Anhui Medical University, 230022 Hefei, China. Electronic address: ay_guew_mz@163.com.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.110032']
2658,32887287,Effects of Thoracic Mobilization and Extension Exercise on Thoracic Alignment and Shoulder Function in Patients with Subacromial Impingement Syndrome: A Randomized Controlled Pilot Study.,"Introduction:  Thoracic kyphosis commonly occurs in subacromial impingement syndrome. This pilot study investigated the effect of thoracic joint mobilization and extension exercise on improving thoracic alignment and shoulder function.  Methods:  In total, 30 patients with subacromial impingement syndrome were recruited and randomly assigned to three groups, the joint mobilization group ( n  = 10), exercise group ( n  = 10), and combination group ( n  = 10). After four weeks of treatment, the measured outcomes included thoracic kyphosis using a manual inclinometer; pectoralis major (PM) and upper trapezius (UT) muscle tone and stiffness using the MyotonPRO ® ; affected side passive range of motion (ROM) using the goniometer (flexion, abduction, medial rotation, and lateral rotation); and shoulder pain and disability index (SPADI).  Results:  All three groups had significant improvements in all variables ( p  < 0.05). Thoracic kyphosis; UT muscle tone; and flexion, medial rotation, and lateral rotation ROM and SPADI were all significantly improved in the combination group compared to the mobilization and exercise groups ( p  < 0.05).  Conclusions:  The combination therapy of thoracic mobilization and extension exercise can be regarded as a promising method to improve thoracic alignment and shoulder function in patients with subacromial impingement syndrome.",2020,All three groups had significant improvements in all variables ( p  < 0.05).,"['30 patients with subacromial impingement syndrome', 'Patients with Subacromial Impingement Syndrome', 'subacromial impingement syndrome', 'patients with subacromial impingement syndrome']","['thoracic joint mobilization and extension exercise', 'joint mobilization group', 'Thoracic Mobilization and Extension Exercise', 'thoracic mobilization and extension exercise', 'exercise group']","['thoracic kyphosis using a manual inclinometer; pectoralis major (PM) and upper trapezius (UT) muscle tone and stiffness using the MyotonPRO ® ; affected side passive range of motion (ROM) using the goniometer (flexion, abduction, medial rotation, and lateral rotation); and shoulder pain and disability index (SPADI', 'flexion, medial rotation, and lateral rotation ROM and SPADI', 'Thoracic Alignment and Shoulder Function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376685', 'cui_str': 'Impingement syndrome of shoulder region'}]","[{'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0231588', 'cui_str': 'Physiatric mobilization of joint'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}]","[{'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0022821', 'cui_str': 'Kyphosis deformity of spine'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0224361', 'cui_str': 'Structure of trapezius muscle'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0079991', 'cui_str': 'Passive movement'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0086505', 'cui_str': 'Kidnapping'}, {'cui': 'C0231459', 'cui_str': 'Internal rotation'}, {'cui': 'C0231462', 'cui_str': 'External rotation'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0948106', 'cui_str': 'Amniorrhexis'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",30.0,0.0817838,All three groups had significant improvements in all variables ( p  < 0.05).,"[{'ForeName': 'Shin Jun', 'Initials': 'SJ', 'LastName': 'Park', 'Affiliation': 'Department of Physical Therapy, Gangdong University, 278, Daehak-gil, Gamgok-myeon, Eumseong-gun, Chungcheongbuk-do 27600, Korea.'}, {'ForeName': 'Seok Hyeon', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'Department of Physical Therapy, General Graduate School, Yongin University, 134, Yongindaehak-ro, Cheoin-gu, Yongin-si, Gyeonggi-do 17092, Korea.'}, {'ForeName': 'Soon Hee', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'Department of Physical Therapy, Yongin University, 134, Yongindaehak-ro, Cheoin-gu, Yongin-si, Gyeonggi-do 17092, Korea.'}]","Healthcare (Basel, Switzerland)",['10.3390/healthcare8030316']
2659,32891738,Efficacy and safety of micafungin in empiric and D-index-guided early antifungal therapy for febrile neutropenia; A subgroup analysis of the CEDMIC trial.,"OBJECTIVES


The D-index is defined as the area over the neutrophil curve during neutropenia. The CEDMIC trial confirmed the noninferiority of D-index-guided early antifungal therapy (DET) using micafungin to empirical antifungal therapy (EAT). In this study, we evaluated the efficacy and safety of micafungin in these settings.
METHODS


From the CEDMIC trial, we extracted 67 and 113 patients who received micafungin in the DET and EAT groups, respectively. Treatment success was defined as the fulfilment of all components of a five-part composite end point. Fever resolution was evaluated at seven days after the completion of therapy.
RESULTS


The proportion of high-risk treatments including induction chemotherapy for acute leukemia and allogeneic hematopoietic stem cell transplantation was significantly higher in the DET group than in the EAT group (82.1% vs. 52.2%). The efficacy of micafungin was 68.7% (95%CI: 56.2-79.4) and 79.6% (71.0-86.6) in the DET and EAT groups, respectively. When we focused on high-risk treatments, the efficacy was 69.1% (55.2-80.9%) and 78.0% (65.3-87.7%), respectively (P = 0.30). There was no significant difference in any of the 5 components between the two groups.
CONCLUSIONS


The efficacy of micafungin in patients undergoing high-risk treatment was not strongly impaired in DET compared to that in EAT.",2020,The efficacy of micafungin in patients undergoing high-risk treatment was not strongly impaired in DET compared to that in EAT.,"['febrile neutropenia', 'patients undergoing high-risk treatment', '113 patients who received micafungin in the DET and EAT groups, respectively', 'From the CEDMIC trial']",['micafungin'],"['efficacy and safety', 'Efficacy and safety', 'Fever resolution', 'acute leukemia and allogeneic hematopoietic stem cell transplantation']","[{'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1120386', 'cui_str': 'micafungin'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0678026', 'cui_str': 'Antifungal therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C1120386', 'cui_str': 'micafungin'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0085669', 'cui_str': 'Acute leukemia'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}]",,0.054726,The efficacy of micafungin in patients undergoing high-risk treatment was not strongly impaired in DET compared to that in EAT.,"[{'ForeName': 'Shun-Ichi', 'Initials': 'SI', 'LastName': 'Kimura', 'Affiliation': 'Division of Hematology, Jichi Medical University Saitama Medical Center, Japan.'}, {'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Kanda', 'Affiliation': 'Division of Hematology, Jichi Medical University Saitama Medical Center, Japan; Division of Hematology, Department of Medicine, Jichi Medical University, Japan. Electronic address: ycanda-tky@umin.ac.jp.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Iino', 'Affiliation': 'Department of Medical Oncology, Yamanashi Prefectural Central Hospital, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Fukuda', 'Affiliation': 'Department of Hematopoietic Stem Cell Transplantation, National Cancer Center Hospital, Japan.'}, {'ForeName': 'Emiko', 'Initials': 'E', 'LastName': 'Sakaida', 'Affiliation': 'Department of Hematology, Chiba University Hospital, Japan.'}, {'ForeName': 'Tatsuo', 'Initials': 'T', 'LastName': 'Oyake', 'Affiliation': 'Division of Hematology and Oncology, Department of Internal Medicine, Iwate Medical University School of Medicine, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Yamaguchi', 'Affiliation': 'Department of Hematology, Nippon Medical School, Japan.'}, {'ForeName': 'Shin-Ichiro', 'Initials': 'SI', 'LastName': 'Fujiwara', 'Affiliation': 'Division of Hematology, Department of Medicine, Jichi Medical University, Japan.'}, {'ForeName': 'Yumi', 'Initials': 'Y', 'LastName': 'Jo', 'Affiliation': 'Department of Oncology and Hematology / Infection Control Division, Shimane University Hospital, Japan.'}, {'ForeName': 'Akinao', 'Initials': 'A', 'LastName': 'Okamoto', 'Affiliation': 'Department of Hematology, Fujita Health University School of Medicine, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Fujita', 'Affiliation': 'Department of Hematology, Saiseikai Yokohama Nanbu Hospital, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Takamatsu', 'Affiliation': 'Division of Medical Oncology, Hematology and Infectious Diseases, Department of Internal Medicine, Fukuoka University Hospital, Japan.'}, {'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Saburi', 'Affiliation': 'Department of Hematology, Oita Prefectural Hospital, Japan.'}, {'ForeName': 'Itaru', 'Initials': 'I', 'LastName': 'Matsumura', 'Affiliation': 'Department of Hematology and Rheumatology, Kindai University Faculty of Medicine, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Yamanouchi', 'Affiliation': 'Departments of Hematology, Clinical Immunology and Infectious Diseases, Ehime University Graduate School of Medicine, Japan.'}, {'ForeName': 'Souichi', 'Initials': 'S', 'LastName': 'Shiratori', 'Affiliation': 'Department of Hematology, Hokkaido University, Faculty of Medicine, Japan.'}, {'ForeName': 'Moritaka', 'Initials': 'M', 'LastName': 'Gotoh', 'Affiliation': 'Department of Hematology, Tokyo Medical University, Japan.'}, {'ForeName': 'Shingen', 'Initials': 'S', 'LastName': 'Nakamura', 'Affiliation': 'Department of Community Medicine and Medical Science, Tokushima University Graduate School of Biomedical Sciences, Japan.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Tamura', 'Affiliation': 'General Medical Research Center, Fukuoka University, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases,['10.1016/j.ijid.2020.08.081']
2660,32891871,No tDCS augmented working memory training benefit in undergraduates rewarded with course credit.,"BACKGROUND


The goal of working memory (WM) training is to expand capacity of this executive function. Transcranial direct current stimulation (tDCS) paired with WM training is more consistent than either alone. We have reported that tDCS targeting frontal and/or parietal regions enhanced theta phase locking, reduced alpha power, and strengthened theta-gamma phase amplitude coupling.
OBJECTIVE


To determine whether tDCS to frontal or parietal sites optimized WM training gains we pre-registered a tDCS-WM training study.
METHODS


80 undergraduates were randomly assigned to one of four anodal tDCS montages: frontal (F4), parietal (P4), alternating (P4-F4), and sham (P4 or F4). Participants completed 5-training sessions over one week and returned for follow-up testing after 30 days of no-contact.
RESULTS


No group showed significant improvement in trained or transfer task performance at the end of training nor at follow-up.
CONCLUSIONS


This null finding marks a failure to replicate in undergraduates training benefits observed in graduate students. We argue that motivation is essential to elicit improved performance in training protocols.",2020,"No group showed significant improvement in trained or transfer task performance at the end of training nor at follow-up.
","['graduate students', '80 undergraduates']","['anodal tDCS montages: frontal (F4), parietal (P4), alternating (P4-F4), and sham (P4 or F4', 'Transcranial direct current stimulation (tDCS) paired with WM training', 'working memory (WM) training']",['trained or transfer task performance'],"[{'cui': 'C0588053', 'cui_str': 'Graduate'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0442030', 'cui_str': 'Parietal'}, {'cui': 'C0332270', 'cui_str': 'Alternating'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}]",80.0,0.033538,"No group showed significant improvement in trained or transfer task performance at the end of training nor at follow-up.
","[{'ForeName': 'Jorja', 'Initials': 'J', 'LastName': 'Shires', 'Affiliation': 'University of Nevada, Program in Cognitive and Brain Sciences, Department of Psychology, Reno, NV, 89557, USA.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Carrasco', 'Affiliation': 'University of Nevada, Program in Cognitive and Brain Sciences, Department of Psychology, Reno, NV, 89557, USA; University of California, Davis, Program in Neuroscience, Davis, CA, 95616, USA.'}, {'ForeName': 'Marian E', 'Initials': 'ME', 'LastName': 'Berryhill', 'Affiliation': 'University of Nevada, Program in Cognitive and Brain Sciences, Department of Psychology, Reno, NV, 89557, USA. Electronic address: mberryhill@unr.edu.'}]",Brain stimulation,['10.1016/j.brs.2020.08.015']
2661,32891892,A multicenter effectiveness trial of QEEG-informed neurofeedback in ADHD: Replication and treatment prediction.,"INTRODUCTION


Quantitative Electroencephalogram-(QEEG-)informed neurofeedback is a method in which standard neurofeedback protocols are assigned, based on individual EEG characteristics in order to enhance effectiveness. Thus far clinical effectiveness data have only been published in a small sample of 21 ADHD patients. Therefore, this manuscript aims to replicate this effectiveness in a new sample of 114 patients treated with QEEG-informed neurofeedback, from a large multicentric dataset and to investigate potential predictors of neurofeedback response.
METHODS


A sample of 114 patients were included as a replication sample. Patients were treated with standard neurofeedback protocols (Sensori-Motor-Rhythm (SMR), Theta-Beta (TBR), or Slow Cortical Potential (SCP) neurofeedback), in combination with coaching and sleep hygiene advice. The ADHD Rating Scale (ADHD-RS) and Pittsburgh Sleep Quality Index (PSQI) were assessed at baseline, every 10th session, and at outtake. Holland Sleep Disorder Questionnaire (HSDQ) was assessed at baseline and outtake. Response was defined as ≥25% reduction (R25), ≥50% reduction (R50), and remission. Predictive analyses were focused on predicting remission status.
RESULTS


In the current sample, response rates were 85% (R25), 70% (R50), and remission was 55% and clinical effectiveness was not significantly different from the original 2012 sample. Non-remitters exhibited significantly higher baseline hyperactivity ratings. Women who remitted had significantly shorter P300 latencies and boys who remitted had significantly lower iAPF's.
DISCUSSION


In the current sample, clinical effectiveness was replicated, suggesting it is possible to assign patients to a protocol based on their individual baseline QEEG to enhance signal-to-noise ratio. Furthermore, remitters had lower baseline hyperactivity scores. Likewise, female remitters had shorter P300 latencies, whereas boys who remitted have a lower iAPF. Our data suggests initial specificity in treatment allocation, yet further studies are needed to replicate the predictors of neurofeedback remission.",2020,"Women who remitted had significantly shorter P300 latencies and boys who remitted had significantly lower iAPF's.
","['21 ADHD patients', 'A sample of 114 patients were included as a replication sample', '114 patients treated with QEEG-informed neurofeedback, from a large multicentric dataset']","['standard neurofeedback protocols (Sensori-Motor-Rhythm (SMR), Theta-Beta (TBR), or Slow Cortical Potential (SCP) neurofeedback), in combination with coaching and sleep hygiene advice', 'QEEG']","['Holland Sleep Disorder Questionnaire (HSDQ', 'response rates', 'ADHD Rating Scale (ADHD-RS) and Pittsburgh Sleep Quality Index (PSQI', 'baseline hyperactivity scores', 'shorter P300 latencies', 'clinical effectiveness', 'baseline hyperactivity ratings']","[{'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0598312', 'cui_str': 'DNA replication'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0700287', 'cui_str': 'Informing'}, {'cui': 'C2713543', 'cui_str': 'Electroencephalographic biofeedback'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0439743', 'cui_str': 'Multicentric'}, {'cui': 'C0150098', 'cui_str': 'Data Set'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C2713543', 'cui_str': 'Electroencephalographic biofeedback'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C4277672', 'cui_str': 'Good Sleep Habits'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}]","[{'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0851578', 'cui_str': 'Sleep disorder'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0424295', 'cui_str': 'Hyperactive behavior'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0444781', 'cui_str': 'P300 (P3)'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}]",114.0,0.0593453,"Women who remitted had significantly shorter P300 latencies and boys who remitted had significantly lower iAPF's.
","[{'ForeName': 'Noralie', 'Initials': 'N', 'LastName': 'Krepel', 'Affiliation': 'Dept. of Cognitive Neuroscience, Faculty of Psychology and Neuroscience, Maastricht University, Maastricht, The Netherlands; Research Institute Brainclinics, Brainclinics Foundation, Nijmegen, The Netherlands.'}, {'ForeName': 'Tommy', 'Initials': 'T', 'LastName': 'Egtberts', 'Affiliation': 'neuroCare Group Netherlands, Nijmegen, The Netherlands.'}, {'ForeName': 'Alexander T', 'Initials': 'AT', 'LastName': 'Sack', 'Affiliation': 'Dept. of Cognitive Neuroscience, Faculty of Psychology and Neuroscience, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Heinrich', 'Affiliation': 'Research Institute Brainclinics, Brainclinics Foundation, Nijmegen, The Netherlands; neuroCare Group, Munich, Germany; kbo-Heckscher-Klinikum, Munich, Germany.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Ryan', 'Affiliation': 'neuroCare Group, Sydney, Australia.'}, {'ForeName': 'Martijn', 'Initials': 'M', 'LastName': 'Arns', 'Affiliation': 'Dept. of Cognitive Neuroscience, Faculty of Psychology and Neuroscience, Maastricht University, Maastricht, The Netherlands; Research Institute Brainclinics, Brainclinics Foundation, Nijmegen, The Netherlands; Dept. of Experimental Psychology, Utrecht University, Utrecht, The Netherlands. Electronic address: martijn@brainclinics.com.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2020.102399']
2662,32895879,Modelling the cost-effectiveness of person-centred care for patients with acute coronary syndrome.,"BACKGROUND


Person-centred care has been shown to be cost-effective compared to usual care for several diseases, including acute coronary syndrome, in a short-term time perspective (< 2 years). The cost-effectiveness of person-centred care in a longer time perspective is largely unknown.
OBJECTIVES


To estimate the mid-term cost-effectiveness of person-centred care compared to usual care for patients (< 65) with acute coronary syndrome, using a 2-year and a 5-year time perspective.
METHODS


The mid-term cost-effectiveness of person-centred care compared to usual care was estimated by projecting the outcomes observed in a randomized-controlled trial together with data from health registers and data from the scientific literature, 3 years beyond the 2-year follow-up, using the developed simulation model. Probabilistic sensitivity analyses were performed using Monte Carlo simulation.
RESULTS


Person-centred care entails lower costs and improved effectiveness as compared to usual care, for a 2-year time and a 5-year perspective. Monte Carlo simulations suggest that the likelihoods of the person-centred care being cost-effective compared to usual care were between 80 and 99% and between 75 and 90% for a 2-year and a 5-year time perspective (using a 500,000 SEK/QALY willingness-to-pay threshold).
CONCLUSIONS


Person-centred care was less costly and more effective compared to usual care in a 2-year and a 5-year time perspective for patients with acute coronary syndrome under the age of 65.",2020,"RESULTS


Person-centred care entails lower costs and improved effectiveness as compared to usual care, for a 2-year time and a 5-year perspective.","['patients (<\u200965) with acute coronary syndrome, using a 2-year and a 5-year time perspective', 'patients with acute coronary syndrome', 'patients with acute coronary syndrome under the age of 65']",['person-centred care'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0040226', 'cui_str': 'Time Perception'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205099', 'cui_str': 'Central'}]",[],,0.0392597,"RESULTS


Person-centred care entails lower costs and improved effectiveness as compared to usual care, for a 2-year time and a 5-year perspective.","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Pirhonen', 'Affiliation': 'Institute of Health and Care Sciences, Sahlgrenska Academy, University of Gothenburg, Box 457, 405 30, Gothenburg, Sweden. laura.pirhonen@economics.gu.se.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Gyllensten', 'Affiliation': 'Institute of Health and Care Sciences, Sahlgrenska Academy, University of Gothenburg, Box 457, 405 30, Gothenburg, Sweden.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Fors', 'Affiliation': 'Institute of Health and Care Sciences, Sahlgrenska Academy, University of Gothenburg, Box 457, 405 30, Gothenburg, Sweden.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Bolin', 'Affiliation': 'Centre for Health Economics (CHEGU), Department of Economics, University of Gothenburg, Gothenburg, Sweden.'}]",The European journal of health economics : HEPAC : health economics in prevention and care,['10.1007/s10198-020-01230-8']
2663,32897035,Inhaled Molgramostim Therapy in Autoimmune Pulmonary Alveolar Proteinosis.,"BACKGROUND


Autoimmune pulmonary alveolar proteinosis (aPAP) is a rare disease characterized by progressive surfactant accumulation and hypoxemia. It is caused by disruption of granulocyte-macrophage colony-stimulating factor (GM-CSF) signaling, which pulmonary alveolar macrophages require to clear surfactant. Recently, inhaled GM-CSF was shown to improve the partial pressure of arterial oxygen in patients with aPAP.
METHODS


In a double-blind, placebo-controlled, three-group trial, we randomly assigned patients with aPAP to receive the recombinant GM-CSF molgramostim (300 μg once daily by inhalation), either continuously or intermittently (every other week), or matching placebo. The 24-week intervention period was followed by an open-label treatment-extension period. The primary end point was the change from baseline in the alveolar-arterial difference in oxygen concentration (A-aDo 2 ) at week 24.
RESULTS


In total, 138 patients underwent randomization; 46 were assigned to receive continuous molgramostim, 45 to receive intermittent molgramostim, and 47 to receive placebo. Invalid A-aDo 2  data for 4 patients (1 in each molgramostim group and 2 in the placebo group) who received nasal oxygen therapy during arterial blood gas measurement were replaced by means of imputation. For the primary end point - the change from baseline in the A-aDo 2  at week 24 - improvement was greater among patients receiving continuous molgramostim than among those receiving placebo (-12.8 mm Hg vs. -6.6 mm Hg; estimated treatment difference, -6.2 mm Hg; P = 0.03 by comparison of least-squares means). Patients receiving continuous molgramostim also had greater improvement than those receiving placebo for secondary end points, including the change from baseline in the St. George's Respiratory Questionnaire total score at week 24 (-12.4 points vs. -5.1 points; estimated treatment difference, -7.4 points; P = 0.01 by comparison of least-squares means). For multiple end points, improvement was greater with continuous molgramostim than with intermittent molgramostim. The percentages of patients with adverse events and serious adverse events were similar in the three groups, except for the percentage of patients with chest pain, which was higher in the continuous-molgramostim group.
CONCLUSIONS


In patients with aPAP, daily administration of inhaled molgramostim resulted in greater improvements in pulmonary gas transfer and functional health status than placebo, with similar rates of adverse events. (Funded by Savara Pharmaceuticals; IMPALA ClinicalTrials.gov number, NCT02702180.).",2020,"The percentages of patients with adverse events and serious adverse events were similar in the three groups, except for the percentage of patients with chest pain, which was higher in the continuous-molgramostim group.
","['Autoimmune Pulmonary Alveolar Proteinosis', 'patients with aPAP', '4 patients (1 in each molgramostim group and 2 in the placebo group) who received', '138 patients underwent randomization; 46 were assigned to receive']","['nasal oxygen therapy', 'Inhaled Molgramostim Therapy', 'placebo', 'continuous molgramostim, 45 to receive intermittent molgramostim, and 47 to receive placebo', 'inhaled molgramostim', 'recombinant GM-CSF molgramostim']","['alveolar-arterial difference in oxygen concentration', 'partial pressure of arterial oxygen', 'pulmonary gas transfer and functional health status', 'adverse events', 'adverse events and serious adverse events', ""St. George's Respiratory Questionnaire total score""]","[{'cui': 'C1970472', 'cui_str': 'Autoimmune pulmonary alveolar proteinosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0218633', 'cui_str': 'molgramostim'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0218633', 'cui_str': 'molgramostim'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0018183', 'cui_str': 'Granulocyte'}, {'cui': 'C0079784', 'cui_str': 'Colony-stimulating factor, macrophage'}]","[{'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0428646', 'cui_str': 'Oxygen concentration'}, {'cui': 'C0030604', 'cui_str': 'Partial pressure'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",138.0,0.336607,"The percentages of patients with adverse events and serious adverse events were similar in the three groups, except for the percentage of patients with chest pain, which was higher in the continuous-molgramostim group.
","[{'ForeName': 'Bruce C', 'Initials': 'BC', 'LastName': 'Trapnell', 'Affiliation': 'From the Translational Pulmonary Science Center, Cincinnati Children\'s Hospital Medical Center, Cincinnati (B.C.T.); National Hospital Organization Kinki-Chuo Chest Medical Center, Osaka (Y.I.), Aichi Medical University Hospital, Nagakute, Aichi (E.Y.), and Kanagawa Cardiovascular and Respiratory Center, Yokohama (T.B.) - all in Japan; Outpatients Clinic for Interstitial and Rare Lung Disease, Ruhrlandklinik University Hospital, Essen (F.B.), and Center for Interstitial and Rare Lung Diseases, Pulmonology, Thoraxklinik, Heidelberg University Hospital, and German Center for Lung Research, Heidelberg (M.K.) - all in Germany; the Departments of Critical Care and Respiratory Medicine, Royal Brompton Hospital, London (C.M.); Respiratory Diseases Department, Pontchaillou Hospital, IRSET UMR 1085, Rennes 1 University, Rennes, France (S.J.); the Department of Respiratory Diseases and Allergy, Aarhus University Hospital, Aarhus (E.B.), and Savara, Horsholm (C.G., I.T.) - both in Denmark; the Pneumology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy (I.C.); the 2nd Pulmonary Medicine Department, General University Hospital ""Attikon,"" Medical School, National and Kapodistrian University of Athens, Athens (S.A.P.); University of Health Sciences Turkey, Yedikule Chest Diseases and Thoracic Surgery Education and Research Hospital, Istanbul (E.C.); Pulmonary Clinic of St. Petersburg Pavlov State Medical University, St. Petersburg, Russia (M.M.I.); Institute of Pulmonary and Allergy Medicine, Rabin Medical Center, Petah Tikva, Israel (M.R.K.); ILD Center of Excellence, Department of Pulmonology, St. Antonius Hospital, Nieuwegein, the Netherlands (M.V.); the University of Western Australia, Royal Perth Hospital, Perth, Australia (G.W.); and Savara, Austin, TX (T.J.).'}, {'ForeName': 'Yoshikazu', 'Initials': 'Y', 'LastName': 'Inoue', 'Affiliation': 'From the Translational Pulmonary Science Center, Cincinnati Children\'s Hospital Medical Center, Cincinnati (B.C.T.); National Hospital Organization Kinki-Chuo Chest Medical Center, Osaka (Y.I.), Aichi Medical University Hospital, Nagakute, Aichi (E.Y.), and Kanagawa Cardiovascular and Respiratory Center, Yokohama (T.B.) - all in Japan; Outpatients Clinic for Interstitial and Rare Lung Disease, Ruhrlandklinik University Hospital, Essen (F.B.), and Center for Interstitial and Rare Lung Diseases, Pulmonology, Thoraxklinik, Heidelberg University Hospital, and German Center for Lung Research, Heidelberg (M.K.) - all in Germany; the Departments of Critical Care and Respiratory Medicine, Royal Brompton Hospital, London (C.M.); Respiratory Diseases Department, Pontchaillou Hospital, IRSET UMR 1085, Rennes 1 University, Rennes, France (S.J.); the Department of Respiratory Diseases and Allergy, Aarhus University Hospital, Aarhus (E.B.), and Savara, Horsholm (C.G., I.T.) - both in Denmark; the Pneumology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy (I.C.); the 2nd Pulmonary Medicine Department, General University Hospital ""Attikon,"" Medical School, National and Kapodistrian University of Athens, Athens (S.A.P.); University of Health Sciences Turkey, Yedikule Chest Diseases and Thoracic Surgery Education and Research Hospital, Istanbul (E.C.); Pulmonary Clinic of St. Petersburg Pavlov State Medical University, St. Petersburg, Russia (M.M.I.); Institute of Pulmonary and Allergy Medicine, Rabin Medical Center, Petah Tikva, Israel (M.R.K.); ILD Center of Excellence, Department of Pulmonology, St. Antonius Hospital, Nieuwegein, the Netherlands (M.V.); the University of Western Australia, Royal Perth Hospital, Perth, Australia (G.W.); and Savara, Austin, TX (T.J.).'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Bonella', 'Affiliation': 'From the Translational Pulmonary Science Center, Cincinnati Children\'s Hospital Medical Center, Cincinnati (B.C.T.); National Hospital Organization Kinki-Chuo Chest Medical Center, Osaka (Y.I.), Aichi Medical University Hospital, Nagakute, Aichi (E.Y.), and Kanagawa Cardiovascular and Respiratory Center, Yokohama (T.B.) - all in Japan; Outpatients Clinic for Interstitial and Rare Lung Disease, Ruhrlandklinik University Hospital, Essen (F.B.), and Center for Interstitial and Rare Lung Diseases, Pulmonology, Thoraxklinik, Heidelberg University Hospital, and German Center for Lung Research, Heidelberg (M.K.) - all in Germany; the Departments of Critical Care and Respiratory Medicine, Royal Brompton Hospital, London (C.M.); Respiratory Diseases Department, Pontchaillou Hospital, IRSET UMR 1085, Rennes 1 University, Rennes, France (S.J.); the Department of Respiratory Diseases and Allergy, Aarhus University Hospital, Aarhus (E.B.), and Savara, Horsholm (C.G., I.T.) - both in Denmark; the Pneumology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy (I.C.); the 2nd Pulmonary Medicine Department, General University Hospital ""Attikon,"" Medical School, National and Kapodistrian University of Athens, Athens (S.A.P.); University of Health Sciences Turkey, Yedikule Chest Diseases and Thoracic Surgery Education and Research Hospital, Istanbul (E.C.); Pulmonary Clinic of St. Petersburg Pavlov State Medical University, St. Petersburg, Russia (M.M.I.); Institute of Pulmonary and Allergy Medicine, Rabin Medical Center, Petah Tikva, Israel (M.R.K.); ILD Center of Excellence, Department of Pulmonology, St. Antonius Hospital, Nieuwegein, the Netherlands (M.V.); the University of Western Australia, Royal Perth Hospital, Perth, Australia (G.W.); and Savara, Austin, TX (T.J.).'}, {'ForeName': 'Cliff', 'Initials': 'C', 'LastName': 'Morgan', 'Affiliation': 'From the Translational Pulmonary Science Center, Cincinnati Children\'s Hospital Medical Center, Cincinnati (B.C.T.); National Hospital Organization Kinki-Chuo Chest Medical Center, Osaka (Y.I.), Aichi Medical University Hospital, Nagakute, Aichi (E.Y.), and Kanagawa Cardiovascular and Respiratory Center, Yokohama (T.B.) - all in Japan; Outpatients Clinic for Interstitial and Rare Lung Disease, Ruhrlandklinik University Hospital, Essen (F.B.), and Center for Interstitial and Rare Lung Diseases, Pulmonology, Thoraxklinik, Heidelberg University Hospital, and German Center for Lung Research, Heidelberg (M.K.) - all in Germany; the Departments of Critical Care and Respiratory Medicine, Royal Brompton Hospital, London (C.M.); Respiratory Diseases Department, Pontchaillou Hospital, IRSET UMR 1085, Rennes 1 University, Rennes, France (S.J.); the Department of Respiratory Diseases and Allergy, Aarhus University Hospital, Aarhus (E.B.), and Savara, Horsholm (C.G., I.T.) - both in Denmark; the Pneumology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy (I.C.); the 2nd Pulmonary Medicine Department, General University Hospital ""Attikon,"" Medical School, National and Kapodistrian University of Athens, Athens (S.A.P.); University of Health Sciences Turkey, Yedikule Chest Diseases and Thoracic Surgery Education and Research Hospital, Istanbul (E.C.); Pulmonary Clinic of St. Petersburg Pavlov State Medical University, St. Petersburg, Russia (M.M.I.); Institute of Pulmonary and Allergy Medicine, Rabin Medical Center, Petah Tikva, Israel (M.R.K.); ILD Center of Excellence, Department of Pulmonology, St. Antonius Hospital, Nieuwegein, the Netherlands (M.V.); the University of Western Australia, Royal Perth Hospital, Perth, Australia (G.W.); and Savara, Austin, TX (T.J.).'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Jouneau', 'Affiliation': 'From the Translational Pulmonary Science Center, Cincinnati Children\'s Hospital Medical Center, Cincinnati (B.C.T.); National Hospital Organization Kinki-Chuo Chest Medical Center, Osaka (Y.I.), Aichi Medical University Hospital, Nagakute, Aichi (E.Y.), and Kanagawa Cardiovascular and Respiratory Center, Yokohama (T.B.) - all in Japan; Outpatients Clinic for Interstitial and Rare Lung Disease, Ruhrlandklinik University Hospital, Essen (F.B.), and Center for Interstitial and Rare Lung Diseases, Pulmonology, Thoraxklinik, Heidelberg University Hospital, and German Center for Lung Research, Heidelberg (M.K.) - all in Germany; the Departments of Critical Care and Respiratory Medicine, Royal Brompton Hospital, London (C.M.); Respiratory Diseases Department, Pontchaillou Hospital, IRSET UMR 1085, Rennes 1 University, Rennes, France (S.J.); the Department of Respiratory Diseases and Allergy, Aarhus University Hospital, Aarhus (E.B.), and Savara, Horsholm (C.G., I.T.) - both in Denmark; the Pneumology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy (I.C.); the 2nd Pulmonary Medicine Department, General University Hospital ""Attikon,"" Medical School, National and Kapodistrian University of Athens, Athens (S.A.P.); University of Health Sciences Turkey, Yedikule Chest Diseases and Thoracic Surgery Education and Research Hospital, Istanbul (E.C.); Pulmonary Clinic of St. Petersburg Pavlov State Medical University, St. Petersburg, Russia (M.M.I.); Institute of Pulmonary and Allergy Medicine, Rabin Medical Center, Petah Tikva, Israel (M.R.K.); ILD Center of Excellence, Department of Pulmonology, St. Antonius Hospital, Nieuwegein, the Netherlands (M.V.); the University of Western Australia, Royal Perth Hospital, Perth, Australia (G.W.); and Savara, Austin, TX (T.J.).'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Bendstrup', 'Affiliation': 'From the Translational Pulmonary Science Center, Cincinnati Children\'s Hospital Medical Center, Cincinnati (B.C.T.); National Hospital Organization Kinki-Chuo Chest Medical Center, Osaka (Y.I.), Aichi Medical University Hospital, Nagakute, Aichi (E.Y.), and Kanagawa Cardiovascular and Respiratory Center, Yokohama (T.B.) - all in Japan; Outpatients Clinic for Interstitial and Rare Lung Disease, Ruhrlandklinik University Hospital, Essen (F.B.), and Center for Interstitial and Rare Lung Diseases, Pulmonology, Thoraxklinik, Heidelberg University Hospital, and German Center for Lung Research, Heidelberg (M.K.) - all in Germany; the Departments of Critical Care and Respiratory Medicine, Royal Brompton Hospital, London (C.M.); Respiratory Diseases Department, Pontchaillou Hospital, IRSET UMR 1085, Rennes 1 University, Rennes, France (S.J.); the Department of Respiratory Diseases and Allergy, Aarhus University Hospital, Aarhus (E.B.), and Savara, Horsholm (C.G., I.T.) - both in Denmark; the Pneumology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy (I.C.); the 2nd Pulmonary Medicine Department, General University Hospital ""Attikon,"" Medical School, National and Kapodistrian University of Athens, Athens (S.A.P.); University of Health Sciences Turkey, Yedikule Chest Diseases and Thoracic Surgery Education and Research Hospital, Istanbul (E.C.); Pulmonary Clinic of St. Petersburg Pavlov State Medical University, St. Petersburg, Russia (M.M.I.); Institute of Pulmonary and Allergy Medicine, Rabin Medical Center, Petah Tikva, Israel (M.R.K.); ILD Center of Excellence, Department of Pulmonology, St. Antonius Hospital, Nieuwegein, the Netherlands (M.V.); the University of Western Australia, Royal Perth Hospital, Perth, Australia (G.W.); and Savara, Austin, TX (T.J.).'}, {'ForeName': 'Ilaria', 'Initials': 'I', 'LastName': 'Campo', 'Affiliation': 'From the Translational Pulmonary Science Center, Cincinnati Children\'s Hospital Medical Center, Cincinnati (B.C.T.); National Hospital Organization Kinki-Chuo Chest Medical Center, Osaka (Y.I.), Aichi Medical University Hospital, Nagakute, Aichi (E.Y.), and Kanagawa Cardiovascular and Respiratory Center, Yokohama (T.B.) - all in Japan; Outpatients Clinic for Interstitial and Rare Lung Disease, Ruhrlandklinik University Hospital, Essen (F.B.), and Center for Interstitial and Rare Lung Diseases, Pulmonology, Thoraxklinik, Heidelberg University Hospital, and German Center for Lung Research, Heidelberg (M.K.) - all in Germany; the Departments of Critical Care and Respiratory Medicine, Royal Brompton Hospital, London (C.M.); Respiratory Diseases Department, Pontchaillou Hospital, IRSET UMR 1085, Rennes 1 University, Rennes, France (S.J.); the Department of Respiratory Diseases and Allergy, Aarhus University Hospital, Aarhus (E.B.), and Savara, Horsholm (C.G., I.T.) - both in Denmark; the Pneumology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy (I.C.); the 2nd Pulmonary Medicine Department, General University Hospital ""Attikon,"" Medical School, National and Kapodistrian University of Athens, Athens (S.A.P.); University of Health Sciences Turkey, Yedikule Chest Diseases and Thoracic Surgery Education and Research Hospital, Istanbul (E.C.); Pulmonary Clinic of St. Petersburg Pavlov State Medical University, St. Petersburg, Russia (M.M.I.); Institute of Pulmonary and Allergy Medicine, Rabin Medical Center, Petah Tikva, Israel (M.R.K.); ILD Center of Excellence, Department of Pulmonology, St. Antonius Hospital, Nieuwegein, the Netherlands (M.V.); the University of Western Australia, Royal Perth Hospital, Perth, Australia (G.W.); and Savara, Austin, TX (T.J.).'}, {'ForeName': 'Spyros A', 'Initials': 'SA', 'LastName': 'Papiris', 'Affiliation': 'From the Translational Pulmonary Science Center, Cincinnati Children\'s Hospital Medical Center, Cincinnati (B.C.T.); National Hospital Organization Kinki-Chuo Chest Medical Center, Osaka (Y.I.), Aichi Medical University Hospital, Nagakute, Aichi (E.Y.), and Kanagawa Cardiovascular and Respiratory Center, Yokohama (T.B.) - all in Japan; Outpatients Clinic for Interstitial and Rare Lung Disease, Ruhrlandklinik University Hospital, Essen (F.B.), and Center for Interstitial and Rare Lung Diseases, Pulmonology, Thoraxklinik, Heidelberg University Hospital, and German Center for Lung Research, Heidelberg (M.K.) - all in Germany; the Departments of Critical Care and Respiratory Medicine, Royal Brompton Hospital, London (C.M.); Respiratory Diseases Department, Pontchaillou Hospital, IRSET UMR 1085, Rennes 1 University, Rennes, France (S.J.); the Department of Respiratory Diseases and Allergy, Aarhus University Hospital, Aarhus (E.B.), and Savara, Horsholm (C.G., I.T.) - both in Denmark; the Pneumology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy (I.C.); the 2nd Pulmonary Medicine Department, General University Hospital ""Attikon,"" Medical School, National and Kapodistrian University of Athens, Athens (S.A.P.); University of Health Sciences Turkey, Yedikule Chest Diseases and Thoracic Surgery Education and Research Hospital, Istanbul (E.C.); Pulmonary Clinic of St. Petersburg Pavlov State Medical University, St. Petersburg, Russia (M.M.I.); Institute of Pulmonary and Allergy Medicine, Rabin Medical Center, Petah Tikva, Israel (M.R.K.); ILD Center of Excellence, Department of Pulmonology, St. Antonius Hospital, Nieuwegein, the Netherlands (M.V.); the University of Western Australia, Royal Perth Hospital, Perth, Australia (G.W.); and Savara, Austin, TX (T.J.).'}, {'ForeName': 'Etsuro', 'Initials': 'E', 'LastName': 'Yamaguchi', 'Affiliation': 'From the Translational Pulmonary Science Center, Cincinnati Children\'s Hospital Medical Center, Cincinnati (B.C.T.); National Hospital Organization Kinki-Chuo Chest Medical Center, Osaka (Y.I.), Aichi Medical University Hospital, Nagakute, Aichi (E.Y.), and Kanagawa Cardiovascular and Respiratory Center, Yokohama (T.B.) - all in Japan; Outpatients Clinic for Interstitial and Rare Lung Disease, Ruhrlandklinik University Hospital, Essen (F.B.), and Center for Interstitial and Rare Lung Diseases, Pulmonology, Thoraxklinik, Heidelberg University Hospital, and German Center for Lung Research, Heidelberg (M.K.) - all in Germany; the Departments of Critical Care and Respiratory Medicine, Royal Brompton Hospital, London (C.M.); Respiratory Diseases Department, Pontchaillou Hospital, IRSET UMR 1085, Rennes 1 University, Rennes, France (S.J.); the Department of Respiratory Diseases and Allergy, Aarhus University Hospital, Aarhus (E.B.), and Savara, Horsholm (C.G., I.T.) - both in Denmark; the Pneumology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy (I.C.); the 2nd Pulmonary Medicine Department, General University Hospital ""Attikon,"" Medical School, National and Kapodistrian University of Athens, Athens (S.A.P.); University of Health Sciences Turkey, Yedikule Chest Diseases and Thoracic Surgery Education and Research Hospital, Istanbul (E.C.); Pulmonary Clinic of St. Petersburg Pavlov State Medical University, St. Petersburg, Russia (M.M.I.); Institute of Pulmonary and Allergy Medicine, Rabin Medical Center, Petah Tikva, Israel (M.R.K.); ILD Center of Excellence, Department of Pulmonology, St. Antonius Hospital, Nieuwegein, the Netherlands (M.V.); the University of Western Australia, Royal Perth Hospital, Perth, Australia (G.W.); and Savara, Austin, TX (T.J.).'}, {'ForeName': 'Erdogan', 'Initials': 'E', 'LastName': 'Cetinkaya', 'Affiliation': 'From the Translational Pulmonary Science Center, Cincinnati Children\'s Hospital Medical Center, Cincinnati (B.C.T.); National Hospital Organization Kinki-Chuo Chest Medical Center, Osaka (Y.I.), Aichi Medical University Hospital, Nagakute, Aichi (E.Y.), and Kanagawa Cardiovascular and Respiratory Center, Yokohama (T.B.) - all in Japan; Outpatients Clinic for Interstitial and Rare Lung Disease, Ruhrlandklinik University Hospital, Essen (F.B.), and Center for Interstitial and Rare Lung Diseases, Pulmonology, Thoraxklinik, Heidelberg University Hospital, and German Center for Lung Research, Heidelberg (M.K.) - all in Germany; the Departments of Critical Care and Respiratory Medicine, Royal Brompton Hospital, London (C.M.); Respiratory Diseases Department, Pontchaillou Hospital, IRSET UMR 1085, Rennes 1 University, Rennes, France (S.J.); the Department of Respiratory Diseases and Allergy, Aarhus University Hospital, Aarhus (E.B.), and Savara, Horsholm (C.G., I.T.) - both in Denmark; the Pneumology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy (I.C.); the 2nd Pulmonary Medicine Department, General University Hospital ""Attikon,"" Medical School, National and Kapodistrian University of Athens, Athens (S.A.P.); University of Health Sciences Turkey, Yedikule Chest Diseases and Thoracic Surgery Education and Research Hospital, Istanbul (E.C.); Pulmonary Clinic of St. Petersburg Pavlov State Medical University, St. Petersburg, Russia (M.M.I.); Institute of Pulmonary and Allergy Medicine, Rabin Medical Center, Petah Tikva, Israel (M.R.K.); ILD Center of Excellence, Department of Pulmonology, St. Antonius Hospital, Nieuwegein, the Netherlands (M.V.); the University of Western Australia, Royal Perth Hospital, Perth, Australia (G.W.); and Savara, Austin, TX (T.J.).'}, {'ForeName': 'Mikhail M', 'Initials': 'MM', 'LastName': 'Ilkovich', 'Affiliation': 'From the Translational Pulmonary Science Center, Cincinnati Children\'s Hospital Medical Center, Cincinnati (B.C.T.); National Hospital Organization Kinki-Chuo Chest Medical Center, Osaka (Y.I.), Aichi Medical University Hospital, Nagakute, Aichi (E.Y.), and Kanagawa Cardiovascular and Respiratory Center, Yokohama (T.B.) - all in Japan; Outpatients Clinic for Interstitial and Rare Lung Disease, Ruhrlandklinik University Hospital, Essen (F.B.), and Center for Interstitial and Rare Lung Diseases, Pulmonology, Thoraxklinik, Heidelberg University Hospital, and German Center for Lung Research, Heidelberg (M.K.) - all in Germany; the Departments of Critical Care and Respiratory Medicine, Royal Brompton Hospital, London (C.M.); Respiratory Diseases Department, Pontchaillou Hospital, IRSET UMR 1085, Rennes 1 University, Rennes, France (S.J.); the Department of Respiratory Diseases and Allergy, Aarhus University Hospital, Aarhus (E.B.), and Savara, Horsholm (C.G., I.T.) - both in Denmark; the Pneumology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy (I.C.); the 2nd Pulmonary Medicine Department, General University Hospital ""Attikon,"" Medical School, National and Kapodistrian University of Athens, Athens (S.A.P.); University of Health Sciences Turkey, Yedikule Chest Diseases and Thoracic Surgery Education and Research Hospital, Istanbul (E.C.); Pulmonary Clinic of St. Petersburg Pavlov State Medical University, St. Petersburg, Russia (M.M.I.); Institute of Pulmonary and Allergy Medicine, Rabin Medical Center, Petah Tikva, Israel (M.R.K.); ILD Center of Excellence, Department of Pulmonology, St. Antonius Hospital, Nieuwegein, the Netherlands (M.V.); the University of Western Australia, Royal Perth Hospital, Perth, Australia (G.W.); and Savara, Austin, TX (T.J.).'}, {'ForeName': 'Mordechai R', 'Initials': 'MR', 'LastName': 'Kramer', 'Affiliation': 'From the Translational Pulmonary Science Center, Cincinnati Children\'s Hospital Medical Center, Cincinnati (B.C.T.); National Hospital Organization Kinki-Chuo Chest Medical Center, Osaka (Y.I.), Aichi Medical University Hospital, Nagakute, Aichi (E.Y.), and Kanagawa Cardiovascular and Respiratory Center, Yokohama (T.B.) - all in Japan; Outpatients Clinic for Interstitial and Rare Lung Disease, Ruhrlandklinik University Hospital, Essen (F.B.), and Center for Interstitial and Rare Lung Diseases, Pulmonology, Thoraxklinik, Heidelberg University Hospital, and German Center for Lung Research, Heidelberg (M.K.) - all in Germany; the Departments of Critical Care and Respiratory Medicine, Royal Brompton Hospital, London (C.M.); Respiratory Diseases Department, Pontchaillou Hospital, IRSET UMR 1085, Rennes 1 University, Rennes, France (S.J.); the Department of Respiratory Diseases and Allergy, Aarhus University Hospital, Aarhus (E.B.), and Savara, Horsholm (C.G., I.T.) - both in Denmark; the Pneumology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy (I.C.); the 2nd Pulmonary Medicine Department, General University Hospital ""Attikon,"" Medical School, National and Kapodistrian University of Athens, Athens (S.A.P.); University of Health Sciences Turkey, Yedikule Chest Diseases and Thoracic Surgery Education and Research Hospital, Istanbul (E.C.); Pulmonary Clinic of St. Petersburg Pavlov State Medical University, St. Petersburg, Russia (M.M.I.); Institute of Pulmonary and Allergy Medicine, Rabin Medical Center, Petah Tikva, Israel (M.R.K.); ILD Center of Excellence, Department of Pulmonology, St. Antonius Hospital, Nieuwegein, the Netherlands (M.V.); the University of Western Australia, Royal Perth Hospital, Perth, Australia (G.W.); and Savara, Austin, TX (T.J.).'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Veltkamp', 'Affiliation': 'From the Translational Pulmonary Science Center, Cincinnati Children\'s Hospital Medical Center, Cincinnati (B.C.T.); National Hospital Organization Kinki-Chuo Chest Medical Center, Osaka (Y.I.), Aichi Medical University Hospital, Nagakute, Aichi (E.Y.), and Kanagawa Cardiovascular and Respiratory Center, Yokohama (T.B.) - all in Japan; Outpatients Clinic for Interstitial and Rare Lung Disease, Ruhrlandklinik University Hospital, Essen (F.B.), and Center for Interstitial and Rare Lung Diseases, Pulmonology, Thoraxklinik, Heidelberg University Hospital, and German Center for Lung Research, Heidelberg (M.K.) - all in Germany; the Departments of Critical Care and Respiratory Medicine, Royal Brompton Hospital, London (C.M.); Respiratory Diseases Department, Pontchaillou Hospital, IRSET UMR 1085, Rennes 1 University, Rennes, France (S.J.); the Department of Respiratory Diseases and Allergy, Aarhus University Hospital, Aarhus (E.B.), and Savara, Horsholm (C.G., I.T.) - both in Denmark; the Pneumology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy (I.C.); the 2nd Pulmonary Medicine Department, General University Hospital ""Attikon,"" Medical School, National and Kapodistrian University of Athens, Athens (S.A.P.); University of Health Sciences Turkey, Yedikule Chest Diseases and Thoracic Surgery Education and Research Hospital, Istanbul (E.C.); Pulmonary Clinic of St. Petersburg Pavlov State Medical University, St. Petersburg, Russia (M.M.I.); Institute of Pulmonary and Allergy Medicine, Rabin Medical Center, Petah Tikva, Israel (M.R.K.); ILD Center of Excellence, Department of Pulmonology, St. Antonius Hospital, Nieuwegein, the Netherlands (M.V.); the University of Western Australia, Royal Perth Hospital, Perth, Australia (G.W.); and Savara, Austin, TX (T.J.).'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kreuter', 'Affiliation': 'From the Translational Pulmonary Science Center, Cincinnati Children\'s Hospital Medical Center, Cincinnati (B.C.T.); National Hospital Organization Kinki-Chuo Chest Medical Center, Osaka (Y.I.), Aichi Medical University Hospital, Nagakute, Aichi (E.Y.), and Kanagawa Cardiovascular and Respiratory Center, Yokohama (T.B.) - all in Japan; Outpatients Clinic for Interstitial and Rare Lung Disease, Ruhrlandklinik University Hospital, Essen (F.B.), and Center for Interstitial and Rare Lung Diseases, Pulmonology, Thoraxklinik, Heidelberg University Hospital, and German Center for Lung Research, Heidelberg (M.K.) - all in Germany; the Departments of Critical Care and Respiratory Medicine, Royal Brompton Hospital, London (C.M.); Respiratory Diseases Department, Pontchaillou Hospital, IRSET UMR 1085, Rennes 1 University, Rennes, France (S.J.); the Department of Respiratory Diseases and Allergy, Aarhus University Hospital, Aarhus (E.B.), and Savara, Horsholm (C.G., I.T.) - both in Denmark; the Pneumology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy (I.C.); the 2nd Pulmonary Medicine Department, General University Hospital ""Attikon,"" Medical School, National and Kapodistrian University of Athens, Athens (S.A.P.); University of Health Sciences Turkey, Yedikule Chest Diseases and Thoracic Surgery Education and Research Hospital, Istanbul (E.C.); Pulmonary Clinic of St. Petersburg Pavlov State Medical University, St. Petersburg, Russia (M.M.I.); Institute of Pulmonary and Allergy Medicine, Rabin Medical Center, Petah Tikva, Israel (M.R.K.); ILD Center of Excellence, Department of Pulmonology, St. Antonius Hospital, Nieuwegein, the Netherlands (M.V.); the University of Western Australia, Royal Perth Hospital, Perth, Australia (G.W.); and Savara, Austin, TX (T.J.).'}, {'ForeName': 'Tomohisa', 'Initials': 'T', 'LastName': 'Baba', 'Affiliation': 'From the Translational Pulmonary Science Center, Cincinnati Children\'s Hospital Medical Center, Cincinnati (B.C.T.); National Hospital Organization Kinki-Chuo Chest Medical Center, Osaka (Y.I.), Aichi Medical University Hospital, Nagakute, Aichi (E.Y.), and Kanagawa Cardiovascular and Respiratory Center, Yokohama (T.B.) - all in Japan; Outpatients Clinic for Interstitial and Rare Lung Disease, Ruhrlandklinik University Hospital, Essen (F.B.), and Center for Interstitial and Rare Lung Diseases, Pulmonology, Thoraxklinik, Heidelberg University Hospital, and German Center for Lung Research, Heidelberg (M.K.) - all in Germany; the Departments of Critical Care and Respiratory Medicine, Royal Brompton Hospital, London (C.M.); Respiratory Diseases Department, Pontchaillou Hospital, IRSET UMR 1085, Rennes 1 University, Rennes, France (S.J.); the Department of Respiratory Diseases and Allergy, Aarhus University Hospital, Aarhus (E.B.), and Savara, Horsholm (C.G., I.T.) - both in Denmark; the Pneumology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy (I.C.); the 2nd Pulmonary Medicine Department, General University Hospital ""Attikon,"" Medical School, National and Kapodistrian University of Athens, Athens (S.A.P.); University of Health Sciences Turkey, Yedikule Chest Diseases and Thoracic Surgery Education and Research Hospital, Istanbul (E.C.); Pulmonary Clinic of St. Petersburg Pavlov State Medical University, St. Petersburg, Russia (M.M.I.); Institute of Pulmonary and Allergy Medicine, Rabin Medical Center, Petah Tikva, Israel (M.R.K.); ILD Center of Excellence, Department of Pulmonology, St. Antonius Hospital, Nieuwegein, the Netherlands (M.V.); the University of Western Australia, Royal Perth Hospital, Perth, Australia (G.W.); and Savara, Austin, TX (T.J.).'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Ganslandt', 'Affiliation': 'From the Translational Pulmonary Science Center, Cincinnati Children\'s Hospital Medical Center, Cincinnati (B.C.T.); National Hospital Organization Kinki-Chuo Chest Medical Center, Osaka (Y.I.), Aichi Medical University Hospital, Nagakute, Aichi (E.Y.), and Kanagawa Cardiovascular and Respiratory Center, Yokohama (T.B.) - all in Japan; Outpatients Clinic for Interstitial and Rare Lung Disease, Ruhrlandklinik University Hospital, Essen (F.B.), and Center for Interstitial and Rare Lung Diseases, Pulmonology, Thoraxklinik, Heidelberg University Hospital, and German Center for Lung Research, Heidelberg (M.K.) - all in Germany; the Departments of Critical Care and Respiratory Medicine, Royal Brompton Hospital, London (C.M.); Respiratory Diseases Department, Pontchaillou Hospital, IRSET UMR 1085, Rennes 1 University, Rennes, France (S.J.); the Department of Respiratory Diseases and Allergy, Aarhus University Hospital, Aarhus (E.B.), and Savara, Horsholm (C.G., I.T.) - both in Denmark; the Pneumology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy (I.C.); the 2nd Pulmonary Medicine Department, General University Hospital ""Attikon,"" Medical School, National and Kapodistrian University of Athens, Athens (S.A.P.); University of Health Sciences Turkey, Yedikule Chest Diseases and Thoracic Surgery Education and Research Hospital, Istanbul (E.C.); Pulmonary Clinic of St. Petersburg Pavlov State Medical University, St. Petersburg, Russia (M.M.I.); Institute of Pulmonary and Allergy Medicine, Rabin Medical Center, Petah Tikva, Israel (M.R.K.); ILD Center of Excellence, Department of Pulmonology, St. Antonius Hospital, Nieuwegein, the Netherlands (M.V.); the University of Western Australia, Royal Perth Hospital, Perth, Australia (G.W.); and Savara, Austin, TX (T.J.).'}, {'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Tarnow', 'Affiliation': 'From the Translational Pulmonary Science Center, Cincinnati Children\'s Hospital Medical Center, Cincinnati (B.C.T.); National Hospital Organization Kinki-Chuo Chest Medical Center, Osaka (Y.I.), Aichi Medical University Hospital, Nagakute, Aichi (E.Y.), and Kanagawa Cardiovascular and Respiratory Center, Yokohama (T.B.) - all in Japan; Outpatients Clinic for Interstitial and Rare Lung Disease, Ruhrlandklinik University Hospital, Essen (F.B.), and Center for Interstitial and Rare Lung Diseases, Pulmonology, Thoraxklinik, Heidelberg University Hospital, and German Center for Lung Research, Heidelberg (M.K.) - all in Germany; the Departments of Critical Care and Respiratory Medicine, Royal Brompton Hospital, London (C.M.); Respiratory Diseases Department, Pontchaillou Hospital, IRSET UMR 1085, Rennes 1 University, Rennes, France (S.J.); the Department of Respiratory Diseases and Allergy, Aarhus University Hospital, Aarhus (E.B.), and Savara, Horsholm (C.G., I.T.) - both in Denmark; the Pneumology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy (I.C.); the 2nd Pulmonary Medicine Department, General University Hospital ""Attikon,"" Medical School, National and Kapodistrian University of Athens, Athens (S.A.P.); University of Health Sciences Turkey, Yedikule Chest Diseases and Thoracic Surgery Education and Research Hospital, Istanbul (E.C.); Pulmonary Clinic of St. Petersburg Pavlov State Medical University, St. Petersburg, Russia (M.M.I.); Institute of Pulmonary and Allergy Medicine, Rabin Medical Center, Petah Tikva, Israel (M.R.K.); ILD Center of Excellence, Department of Pulmonology, St. Antonius Hospital, Nieuwegein, the Netherlands (M.V.); the University of Western Australia, Royal Perth Hospital, Perth, Australia (G.W.); and Savara, Austin, TX (T.J.).'}, {'ForeName': 'Grant', 'Initials': 'G', 'LastName': 'Waterer', 'Affiliation': 'From the Translational Pulmonary Science Center, Cincinnati Children\'s Hospital Medical Center, Cincinnati (B.C.T.); National Hospital Organization Kinki-Chuo Chest Medical Center, Osaka (Y.I.), Aichi Medical University Hospital, Nagakute, Aichi (E.Y.), and Kanagawa Cardiovascular and Respiratory Center, Yokohama (T.B.) - all in Japan; Outpatients Clinic for Interstitial and Rare Lung Disease, Ruhrlandklinik University Hospital, Essen (F.B.), and Center for Interstitial and Rare Lung Diseases, Pulmonology, Thoraxklinik, Heidelberg University Hospital, and German Center for Lung Research, Heidelberg (M.K.) - all in Germany; the Departments of Critical Care and Respiratory Medicine, Royal Brompton Hospital, London (C.M.); Respiratory Diseases Department, Pontchaillou Hospital, IRSET UMR 1085, Rennes 1 University, Rennes, France (S.J.); the Department of Respiratory Diseases and Allergy, Aarhus University Hospital, Aarhus (E.B.), and Savara, Horsholm (C.G., I.T.) - both in Denmark; the Pneumology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy (I.C.); the 2nd Pulmonary Medicine Department, General University Hospital ""Attikon,"" Medical School, National and Kapodistrian University of Athens, Athens (S.A.P.); University of Health Sciences Turkey, Yedikule Chest Diseases and Thoracic Surgery Education and Research Hospital, Istanbul (E.C.); Pulmonary Clinic of St. Petersburg Pavlov State Medical University, St. Petersburg, Russia (M.M.I.); Institute of Pulmonary and Allergy Medicine, Rabin Medical Center, Petah Tikva, Israel (M.R.K.); ILD Center of Excellence, Department of Pulmonology, St. Antonius Hospital, Nieuwegein, the Netherlands (M.V.); the University of Western Australia, Royal Perth Hospital, Perth, Australia (G.W.); and Savara, Austin, TX (T.J.).'}, {'ForeName': 'Taneli', 'Initials': 'T', 'LastName': 'Jouhikainen', 'Affiliation': 'From the Translational Pulmonary Science Center, Cincinnati Children\'s Hospital Medical Center, Cincinnati (B.C.T.); National Hospital Organization Kinki-Chuo Chest Medical Center, Osaka (Y.I.), Aichi Medical University Hospital, Nagakute, Aichi (E.Y.), and Kanagawa Cardiovascular and Respiratory Center, Yokohama (T.B.) - all in Japan; Outpatients Clinic for Interstitial and Rare Lung Disease, Ruhrlandklinik University Hospital, Essen (F.B.), and Center for Interstitial and Rare Lung Diseases, Pulmonology, Thoraxklinik, Heidelberg University Hospital, and German Center for Lung Research, Heidelberg (M.K.) - all in Germany; the Departments of Critical Care and Respiratory Medicine, Royal Brompton Hospital, London (C.M.); Respiratory Diseases Department, Pontchaillou Hospital, IRSET UMR 1085, Rennes 1 University, Rennes, France (S.J.); the Department of Respiratory Diseases and Allergy, Aarhus University Hospital, Aarhus (E.B.), and Savara, Horsholm (C.G., I.T.) - both in Denmark; the Pneumology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy (I.C.); the 2nd Pulmonary Medicine Department, General University Hospital ""Attikon,"" Medical School, National and Kapodistrian University of Athens, Athens (S.A.P.); University of Health Sciences Turkey, Yedikule Chest Diseases and Thoracic Surgery Education and Research Hospital, Istanbul (E.C.); Pulmonary Clinic of St. Petersburg Pavlov State Medical University, St. Petersburg, Russia (M.M.I.); Institute of Pulmonary and Allergy Medicine, Rabin Medical Center, Petah Tikva, Israel (M.R.K.); ILD Center of Excellence, Department of Pulmonology, St. Antonius Hospital, Nieuwegein, the Netherlands (M.V.); the University of Western Australia, Royal Perth Hospital, Perth, Australia (G.W.); and Savara, Austin, TX (T.J.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1913590']
2664,32891977,Social network heavy drinking moderates the effects of a brief motivational intervention for alcohol use among injured patients.,"BACKGROUND


Limited research has focused on identifying the extent to which social networks impact the effectiveness of brief alcohol interventions delivered in trauma care settings.
OBJECTIVES


The research presented here examines the extent to which the percent of heavy drinkers and percent of abstainers in one's social network moderates the effectiveness of a brief motivational intervention with and without a telephone booster on alcohol use among trauma patients.
METHOD


Secondary data analyses were conducted using data from 596 participants (456males) who were recruited from three urban Level I trauma centers. Patients were randomized to one of the three intervention conditions: brief advice (BA; n = 200), brief motivational intervention (BMI; n = 203), and BMI with a telephone booster (BMI + B; n = 193). For the purpose of the present study, measures of alcohol-specific social network characteristics at baseline and alcohol use at 3- and 6-month follow-up were used.
RESULTS


At low percentages (0% to ~7%) of people in one's social network who are heavy drinkers, there was a negative, statistically significant effect of the BMI conditions versus the BA condition on alcohol use. However, percent of abstainers did not moderate the effects of the BMI conditions.
CONCLUSION


The results suggest that the BMI and BMI + B conditions may be most effective among patients with no heavy drinkers in their social networks. BMIs may benefit from including a component that addresses having one or more heavy drinkers in one's social network.",2021,"Patients were randomized to one of the three intervention conditions: brief advice (BA; n = 200), brief motivational intervention (BMI; n = 203), and BMI with a telephone booster (BMI + B; n = 193).","['injured patients', 'trauma patients', 'Secondary data analyses were conducted using data from 596 participants (456males) who were recruited from three urban Level I trauma centers', 'patients with no heavy drinkers in their social networks']","['motivational intervention', 'motivational intervention with and without a telephone booster', 'brief advice (BA; n\xa0=\xa0200), brief motivational intervention (BMI; n\xa0=\xa0203), and BMI with a telephone booster (BMI\xa0+\xa0B; n\xa0=\xa0193']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0441925', 'cui_str': 'Level I'}, {'cui': 'C0040786', 'cui_str': 'Trauma center'}, {'cui': 'C0001969', 'cui_str': 'Alcohol intoxication'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0020975', 'cui_str': 'Booster vaccination'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C4319558', 'cui_str': '200'}]",[],596.0,0.015999,"Patients were randomized to one of the three intervention conditions: brief advice (BA; n = 200), brief motivational intervention (BMI; n = 203), and BMI with a telephone booster (BMI + B; n = 193).","[{'ForeName': 'Miriam J', 'Initials': 'MJ', 'LastName': 'Alvarez', 'Affiliation': 'Latino Alcohol and Health Disparities Research Center, University of Texas at El Paso, USA. Electronic address: mjalvarez2@miners.utep.edu.'}, {'ForeName': 'Dylan K', 'Initials': 'DK', 'LastName': 'Richards', 'Affiliation': 'Latino Alcohol and Health Disparities Research Center, University of Texas at El Paso, USA.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Oviedo Ramirez', 'Affiliation': 'Latino Alcohol and Health Disparities Research Center, University of Texas at El Paso, USA.'}, {'ForeName': 'Craig A', 'Initials': 'CA', 'LastName': 'Field', 'Affiliation': 'Latino Alcohol and Health Disparities Research Center, University of Texas at El Paso, USA.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106594']
2665,32898787,"Calorie restriction and synbiotics effect on quality of life and edema reduction in breast cancer-related lymphedema, a clinical trial.","BACKGROUND


Little evidence exists regarding the clinical value of synbiotics in the management of post-treatment complications of breast cancer especially breast cancer-related lymphedema (BCRL). This study aimed to investigate the effects of synbiotic supplementation along with calorie restriction on quality of life and edema volume in patients with BCRL.
METHODS


This randomized, placebo-controlled, clinical trial was conducted on 135 overweight and obese women with BCRL aged 18-65 years old. Participants were randomly allocated to receive a calorie-restricted diet plus 10 9  CFU synbiotic supplement (CRS group; n = 45) or placebo (CRP group; n = 45), daily for 10 weeks. Also, a control group (n = 45) with no intervention was included in the trial. All of the participants received Complete Decongestive Therapy for lymphedema treatment. The quality of life score, edema volume and body mass index (BMI) were measured at baseline and end of the trial.
RESULTS


A total of 121 subjects completed the trial. CRS group showed a significant decrease in the total quality of life score (P = 0.004), and it's psychosocial (P = 0.022) and functional (P = 0.002) domain scores, as well as edema volume (P = 0.002) and BMI (P < 0.001) in comparison to the control. However, there were no significant differences in changes in trial outcomes between the CRS and CRP groups.
CONCLUSION


Synbiotic supplementation along with a low-calorie diet was effective in quality of life, edema volume, and BMI improvement; mostly due to low-calorie diet. It seems that adding a dietitian consultation on the lymphedema management strategy may provide a better result in lymphedema control.",2020,"CRS group showed a significant decrease in the total quality of life score (P = 0.004), and it's psychosocial (P = 0.022) and functional (P = 0.002) domain scores, as well as edema volume (P = 0.002) and BMI (P < 0.001) in comparison to the control.","['patients with BCRL', 'breast cancer-related lymphedema', '135 overweight and obese women with BCRL aged 18-65 years old', 'breast cancer especially breast cancer-related lymphedema (BCRL', '121 subjects completed the trial']","['synbiotic supplementation', 'CRS', 'Synbiotic supplementation', 'placebo', 'calorie-restricted diet plus 10 9 \xa0CFU synbiotic supplement (CRS group; n\xa0=\xa045) or placebo (CRP', 'calorie restriction', 'Complete Decongestive Therapy']","['BMI', 'quality of life, edema volume, and BMI improvement', 'quality of life and edema volume', 'edema volume', 'quality of life score, edema volume and body mass index (BMI', 'total quality of life score', 'quality of life and edema reduction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4277512', 'cui_str': 'Breast Cancer-Related Arm Lymphedema'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C2936470', 'cui_str': 'Synbiotics'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0010278', 'cui_str': 'Craniosynostosis syndrome'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2930544', 'cui_str': 'Calorie restricted diet'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0553561', 'cui_str': 'colony-forming unit'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0474212', 'cui_str': 'Reduction of edema'}]",135.0,0.165473,"CRS group showed a significant decrease in the total quality of life score (P = 0.004), and it's psychosocial (P = 0.022) and functional (P = 0.002) domain scores, as well as edema volume (P = 0.002) and BMI (P < 0.001) in comparison to the control.","[{'ForeName': 'Saeideh', 'Initials': 'S', 'LastName': 'Vafa', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mitra', 'Initials': 'M', 'LastName': 'Zarrati', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran. Electronic address: zarrati_ms@yahoo.com.'}, {'ForeName': 'Marjan', 'Initials': 'M', 'LastName': 'Malakootinejad', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ali Saneei', 'Initials': 'AS', 'LastName': 'Totmaj', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Farid', 'Initials': 'F', 'LastName': 'Zayeri', 'Affiliation': 'Proteomics Research Center and Department of Biostatistics, School of Allied Medical Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Salehi', 'Affiliation': 'Department of Biostatistics, School of Public Health, Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Sanati', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shahpar', 'Initials': 'S', 'LastName': 'Haghighat', 'Affiliation': 'Breast Cancer Research Center, Motamed Cancer Institute, ACECR, Tehran, Iran. Electronic address: sha_haghighat@yahoo.com.'}]","Breast (Edinburgh, Scotland)",['10.1016/j.breast.2020.08.008']
2666,32898855,Nudge interventions to reduce fish sauce consumption in Thailand.,"High sodium consumption is one of the four major risk factors contributing to non-communicable diseases around the world. Thailand has one of the highest rates of sodium consumption, with fish sauce being one of the main sources. The aim of this study was to examine whether changes in the micro-environment factors can affect fish sauce consumption behavior in a university setting in Thailand. We implemented four interventions (with one control) in five canteens across a Thai university. The study design was a Latin square, where the five canteens were randomized over five weeks to implement four interventions plus a control. Our interventions included behavior-oriented, cognitive-oriented, and affective-oriented nudges aimed to reduce the amount of fish sauce people add to their noodles during lunchtime at the university canteens. Results indicate that a simple change in how fish sauce was served can reduce fish sauce consumption. Serving fish sauce in a bowl with a spoon reduced the amount of fish sauce used per noodle bowl by 0.25 grams, compared to the normal condition where fish sauce is served in a bottle. Using a specially-designed spoon with a hole induced a larger reduction of 0.58 grams of fish sauce used per bowl. The other two interventions, cognitive- and affective- oriented nudges, also showed reductions of fish sauce usage, but the differences were not statistically significant. The findings can be used for policy implementation to advocate the use of a smaller sized spoon and a bowl to serve fish sauce instead of a bottle to reduce sodium consumption among Thai people.",2020,Using a specially-designed spoon with a hole induced a larger reduction of 0.58 grams of fish sauce used per bowl.,"['Thailand', 'a university setting in Thailand', 'Thai people']",[],['reductions of fish sauce usage'],"[{'cui': 'C0039725', 'cui_str': 'Thailand'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0039724', 'cui_str': 'Thai language'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",[],"[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0016163', 'cui_str': 'Fish'}, {'cui': 'C0453357', 'cui_str': 'Sauce'}, {'cui': 'C0457083', 'cui_str': 'Usage'}]",5.0,0.01837,Using a specially-designed spoon with a hole induced a larger reduction of 0.58 grams of fish sauce used per bowl.,"[{'ForeName': 'Manasigan', 'Initials': 'M', 'LastName': 'Kanchanachitra', 'Affiliation': 'Institute for Population and Social Research, Mahidol University, Nakhon Pathom, Thailand.'}, {'ForeName': 'Chalermpol', 'Initials': 'C', 'LastName': 'Chamchan', 'Affiliation': 'Institute for Population and Social Research, Mahidol University, Nakhon Pathom, Thailand.'}, {'ForeName': 'Churnrurtai', 'Initials': 'C', 'LastName': 'Kanchanachitra', 'Affiliation': 'Institute for Population and Social Research, Mahidol University, Nakhon Pathom, Thailand.'}, {'ForeName': 'Kanyapat', 'Initials': 'K', 'LastName': 'Suttikasem', 'Affiliation': 'Institute for Population and Social Research, Mahidol University, Nakhon Pathom, Thailand.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Gunn', 'Affiliation': 'Department of Public Health Sciences, College of Health and Human Services, University of North Carolina at Charlotte, Charlotte, North Carolina, United States of America.'}, {'ForeName': 'Ivo', 'Initials': 'I', 'LastName': 'Vlaev', 'Affiliation': 'Warwick Business School, University of Warwick, Coventry, United Kingdom.'}]",PloS one,['10.1371/journal.pone.0238642']
2667,32899673,Effects of Maternal Fish Oil and/or 5-Methyl-Tetrahydrofolate Supplementation during Pregnancy on Offspring Brain Resting-State at 10 Years Old: A Follow-Up Study from the NUHEAL Randomized Controlled Trial.,"Recent studies have shown that maternal supplementation with folate and long-chain polyunsaturated fatty acids (LC-PUFAs) during pregnancy may affect children's brain development. We aimed at examining the potential long-term effect of maternal supplementation with fish oil (FO) and/or 5-methyl-tetrahydrofolate (5-MTHF) on the brain functionality of offspring at the age of 9.5-10 years. The current study was conducted as a follow-up of the Spanish participants belonging to the Nutraceuticals for a Healthier Life (NUHEAL) project; 57 children were divided into groups according to mother's supplementation and assessed through functional magnetic resonance imaging (fMRI) scanning and neurodevelopment testing. Independent component analysis and double regression methods were implemented to investigate plausible associations. Children born to mothers supplemented with FO (FO and FO + 5-MTHF groups,  n  = 33) showed weaker functional connectivity in the default mode (DM) (angular gyrus), the sensorimotor (SM) (motor and somatosensory cortices) and the fronto-parietal (FP) (angular gyrus) networks compared to the No-FO group (placebo and 5-MTHF groups,  n  = 24) (P FWE  < 0.05). Furthermore, no differences were found regarding the neuropsychological tests, except for a trend of better results in an object recall (memory) test. Considering the No-FO group, the aforementioned networks were associated negatively with attention and speed-processing functions. Mother's FO supplementation during pregnancy seems to be able to shape resting-state network functioning in their children at school age and appears to produce long-term effects on children´s cognitive processing.",2020,"Furthermore, no differences were found regarding the neuropsychological tests, except for a trend of better results in an object recall (memory) test.","['offspring at the age of 9.5-10 years', 'Spanish participants belonging to the Nutraceuticals for a Healthier Life (NUHEAL) project; 57 children', 'Offspring Brain Resting-State at 10 Years Old']","['maternal supplementation with fish oil (FO) and/or 5-methyl-tetrahydrofolate (5-MTHF', 'FO (FO and FO + 5-MTHF', ""mother's supplementation and assessed through functional magnetic resonance imaging (fMRI) scanning and neurodevelopment testing"", 'Maternal Fish Oil and/or 5-Methyl-Tetrahydrofolate Supplementation', 'maternal supplementation with folate and long-chain polyunsaturated fatty acids (LC-PUFAs']","['object recall (memory) test', 'functional connectivity', 'attention and speed-processing functions', 'sensorimotor (SM) (motor and somatosensory cortices) and the fronto-parietal (FP) (angular gyrus) networks']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517899', 'cui_str': '9.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C1518478', 'cui_str': 'Nutriceuticals'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0591126', 'cui_str': 'AT-10'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0039669', 'cui_str': 'Tetrahydrofolates'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}]","[{'cui': 'C0347997', 'cui_str': 'Physical object'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0037658', 'cui_str': 'Somatosensory Cortex'}, {'cui': 'C0442030', 'cui_str': 'Parietal'}, {'cui': 'C0152305', 'cui_str': 'Structure of angular gyrus'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}]",57.0,0.0369052,"Furthermore, no differences were found regarding the neuropsychological tests, except for a trend of better results in an object recall (memory) test.","[{'ForeName': 'Hatim', 'Initials': 'H', 'LastName': 'Azaryah', 'Affiliation': 'Department of Paediatrics, School of Medicine, University of Granada, Avda. Investigación 11, 18016 Granada, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Verdejo-Román', 'Affiliation': 'Mind, Brain and Behaviour International Research Centre (CIMCYC), University of Granada, 18011 Granada, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Martin-Pérez', 'Affiliation': 'Mind, Brain and Behaviour International Research Centre (CIMCYC), University of Granada, 18011 Granada, Spain.'}, {'ForeName': 'José Antonio', 'Initials': 'JA', 'LastName': 'García-Santos', 'Affiliation': 'Department of Paediatrics, School of Medicine, University of Granada, Avda. Investigación 11, 18016 Granada, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Martínez-Zaldívar', 'Affiliation': 'Department of Paediatrics, School of Medicine, University of Granada, Avda. Investigación 11, 18016 Granada, Spain.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Torres-Espínola', 'Affiliation': 'Department of Paediatrics, School of Medicine, University of Granada, Avda. Investigación 11, 18016 Granada, Spain.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Campos', 'Affiliation': 'Department of Paediatrics, School of Medicine, University of Granada, Avda. Investigación 11, 18016 Granada, Spain.'}, {'ForeName': 'Berthold', 'Initials': 'B', 'LastName': 'Koletzko', 'Affiliation': ""Ludwig-Maximiliams-Universität München, Dr. von Hauner Children's Hospital, University of Munich Hospitals, 80337 Munich, Germany.""}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Pérez-García', 'Affiliation': 'Mind, Brain and Behaviour International Research Centre (CIMCYC), University of Granada, 18011 Granada, Spain.'}, {'ForeName': 'Andrés', 'Initials': 'A', 'LastName': 'Catena', 'Affiliation': 'Mind, Brain and Behaviour International Research Centre (CIMCYC), University of Granada, 18011 Granada, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Campoy', 'Affiliation': 'Department of Paediatrics, School of Medicine, University of Granada, Avda. Investigación 11, 18016 Granada, Spain.'}]",Nutrients,['10.3390/nu12092701']
2668,32901950,Shorter RSPV cryoapplications result in less phrenic nerve injury and similar 1-year freedom from atrial fibrillation.,"BACKGROUND


In the 123-study, we prospectively assessed, in a randomized fashion, the minimal cryoballoon application time necessary to achieve pulmonary vein (PV) isolation (PVI) in patients with paroxysmal atrial fibrillation (AF) with the aim to reduce complications by shortening the application duration. The first results of this study demonstrated that shortened cryoballoon applications (<2 minutes) resulted in less phrenic nerve injury (PNI) without compromising acute isolation efficacy for the right PVs. We now report the 1-year follow-up results regarding safety and efficacy of shorter cryoballoon applications.
METHODS


A total of 222 patients with AF were randomized to two applications of 1 min ""short,"" 2 min ""medium,"" or 3 min ""long"" duration, 74 per group. Recurrence of AF and PV reconduction at 1-year follow-up were assessed.
RESULTS


The overall 1-year freedom from AF was 79% and did not differ significantly between the short, medium, and long application groups (77%, 74%, and 85% for short, medium, and long application groups, respectively; P = 0.07). In 30 patients, a redo PVI procedure was performed. For all four PVs, there was no significant difference in reconduction between the three groups. Reconduction was most common in the left superior PV (57%). The right superior PV (RSPV) showed significantly less reconduction (17%) compared to the other PVs.
CONCLUSIONS


Shortening cryoballoon applications of the RSPV to <2 minutes results in less PNI, while acute success and 1-year freedom from AF are not compromised. Therefore, shorter cryoballoon applications (especially) in the RSPV could be used to reduce PNI.",2020,"The overall 1-year freedom from AF was 79% and did not differ significantly between the short, medium and long application groups (77, 74 and 85% for short, medium and long application groups, respectively; P = 0.07).","['222 patients with AF', 'patients with paroxysmal atrial fibrillation (AF']",['pulmonary vein (PV) isolation (PVI'],"['overall 1-year freedom from AF', 'reconduction', 'Recurrence of AF and PV reconduction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0235480', 'cui_str': 'Paroxysmal atrial fibrillation'}]","[{'cui': 'C0034090', 'cui_str': 'Structure of vein of pulmonary circulation'}, {'cui': 'C0037421', 'cui_str': 'Social isolation'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0034090', 'cui_str': 'Structure of vein of pulmonary circulation'}]",222.0,0.0304896,"The overall 1-year freedom from AF was 79% and did not differ significantly between the short, medium and long application groups (77, 74 and 85% for short, medium and long application groups, respectively; P = 0.07).","[{'ForeName': 'Marleen M D', 'Initials': 'MMD', 'LastName': 'Molenaar', 'Affiliation': 'Medisch Spectrum Twente, Enschede, The Netherlands.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Hesselink', 'Affiliation': 'Medisch Spectrum Twente, Enschede, The Netherlands.'}, {'ForeName': 'Rachel M A', 'Initials': 'RMA', 'LastName': 'Ter Bekke', 'Affiliation': 'Maastricht University Medical Centre, Maastricht, The Netherlands.'}, {'ForeName': 'Marcoen F', 'Initials': 'MF', 'LastName': 'Scholten', 'Affiliation': 'Medisch Spectrum Twente, Enschede, The Netherlands.'}, {'ForeName': 'Randy', 'Initials': 'R', 'LastName': 'Manusama', 'Affiliation': 'Maastricht University Medical Centre, Maastricht, The Netherlands.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Pison', 'Affiliation': 'Ziekenhuis Oost-Limburg, Genk, Belgium.'}, {'ForeName': 'Marjolein', 'Initials': 'M', 'LastName': 'Brusse-Keizer', 'Affiliation': 'Medisch Spectrum Twente, Enschede, The Netherlands.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Kraaier', 'Affiliation': 'Medisch Centrum Leeuwarden, Leeuwarden, The Netherlands.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Ten Haken', 'Affiliation': 'Universiteit Twente, Enschede, The Netherlands.'}, {'ForeName': 'Jan G', 'Initials': 'JG', 'LastName': 'Grandjean', 'Affiliation': 'Medisch Spectrum Twente, Enschede, The Netherlands.'}, {'ForeName': 'Carl C', 'Initials': 'CC', 'LastName': 'Timmermans', 'Affiliation': 'Maastricht University Medical Centre, Maastricht, The Netherlands.'}, {'ForeName': 'Jurren M', 'Initials': 'JM', 'LastName': 'van Opstal', 'Affiliation': 'Medisch Spectrum Twente, Enschede, The Netherlands.'}]",Pacing and clinical electrophysiology : PACE,['10.1111/pace.14062']
2669,32901972,Effects of listening to music in digestive endoscopy: A prospective intervention study led by nursing.,"AIMS


To explore whether music can reduce anxiety and pain in patients who underwent diagnostic endoscopic examinations in conscious and deep sedation and to assess degree of satisfaction and willingness to repeat the procedure.
DESIGN


Prospective study led by nursing.
METHODS


Between March 2019-June 2019, consecutive outpatients undergoing endoscopic examinations were simple matched into four groups: Group 1: conscious sedation with music; Group 2: conscious sedation without music; Group 3: deep sedation with music and Group 4: deep sedation without music. Ten minutes before the procedure, two trainee nurses applied music. State-Trait Anxiety Inventory was used to evaluate anxiety.
RESULTS


Before and at the end of the procedure, patients who listened to music had a lower level anxiety than those who did not listen and, also, reported lower pain intensity during procedure. Only within Group 1 median anxiety, measured after the procedure, is lower than that measured before. In the bivariate logistic regression model, pain and listening to music were independent factors for satisfaction and willingness to repeat procedure.
CONCLUSION


music in digestive endoscopy reduce pain and anxiety in conscious sedation, thus could be used to reduce anxiety in support to conscious sedation leading to lower usage of deep sedation and consequently reduction of costs and adverse events.
IMPACT


Anxiety in digestive endoscopy limits patients' satisfaction. Music in digestive endoscopy as a specific nursing intervention could reduce anxiety of patients. This nursing intervention study confirms positive effect of music in digestive endoscopy. As part of nursing management, the addition of music to daily care practice in digestive endoscopy may reduce anxiety and increase the patient's degree of satisfaction. Use of music could limit deep sedation use in digestive endoscopy with consequent reduction of risks for patients, execution times, and costs of procedures.",2020,"Before and at the end of the procedure, patients who listened to music had a lower level anxiety than those who did not listen and, also, reported lower pain intensity during procedure.","[""digestive endoscopy limits patients' satisfaction"", 'digestive endoscopy', 'patients who underwent diagnostic endoscopic examinations in conscious and deep sedation', 'Between March 2019-June 2019, consecutive outpatients undergoing']","['listening to music', 'music in digestive endoscopy', 'endoscopic examinations', 'conscious sedation with music; Group 2: conscious sedation without music; Group 3: deep sedation with music and Group 4: deep sedation without music']","['pain and anxiety', 'level anxiety', 'pain intensity', 'anxiety and pain', 'median anxiety']","[{'cui': 'C0079278', 'cui_str': 'Gastrointestinal tract endoscopy'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0234421', 'cui_str': 'Consciousness'}, {'cui': 'C1956064', 'cui_str': 'Sedation, Deep'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}]","[{'cui': 'C0004309', 'cui_str': 'Auditory Perception'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0079278', 'cui_str': 'Gastrointestinal tract endoscopy'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0079159', 'cui_str': 'Conscious sedation'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C1956064', 'cui_str': 'Sedation, Deep'}, {'cui': 'C0441876', 'cui_str': 'Group 4'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",,0.072793,"Before and at the end of the procedure, patients who listened to music had a lower level anxiety than those who did not listen and, also, reported lower pain intensity during procedure.","[{'ForeName': 'Rocco', 'Initials': 'R', 'LastName': 'Spagnuolo', 'Affiliation': ""Department of Clinical and Experimental Medicine, University 'Magna Graecia', Catanzaro, Italy.""}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Corea', 'Affiliation': ""Department of Clinical and Experimental Medicine, University 'Magna Graecia', Catanzaro, Italy.""}, {'ForeName': 'Mariantonietta', 'Initials': 'M', 'LastName': 'Blumetti', 'Affiliation': ""School of Nursing, University 'Magna Graecia', Catanzaro, Italy.""}, {'ForeName': 'Alessia', 'Initials': 'A', 'LastName': 'Giovinazzo', 'Affiliation': ""School of Nursing, University 'Magna Graecia', Catanzaro, Italy.""}, {'ForeName': 'Massimiliano', 'Initials': 'M', 'LastName': 'Serafino', 'Affiliation': ""University Medical Hopsital 'Mater Domini', Catanzaro, Italy.""}, {'ForeName': 'Caterina', 'Initials': 'C', 'LastName': 'Pagliuso', 'Affiliation': ""University Medical Hopsital 'Mater Domini', Catanzaro, Italy.""}, {'ForeName': 'Raffaele', 'Initials': 'R', 'LastName': 'Pagnotta', 'Affiliation': ""University Medical Hopsital 'Mater Domini', Catanzaro, Italy.""}, {'ForeName': 'Grazia', 'Initials': 'G', 'LastName': 'Curto', 'Affiliation': ""University Medical Hopsital 'Mater Domini', Catanzaro, Italy.""}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Cosco', 'Affiliation': ""University Medical Hopsital 'Mater Domini', Catanzaro, Italy.""}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Cosco', 'Affiliation': ""University Medical Hopsital 'Mater Domini', Catanzaro, Italy.""}, {'ForeName': 'Rosellina Margherita', 'Initials': 'RM', 'LastName': 'Mancina', 'Affiliation': 'Department of Molecular and Clinical Medicine, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Garieri', 'Affiliation': 'European Institute of Oncology, Milan, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Papaleo', 'Affiliation': 'Maggiore Hospital, Milan, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Grande', 'Affiliation': 'Department of Abdominal Surgery, S. Rita Clinic, Vercelli, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Barilaro', 'Affiliation': ""University Medical Hopsital 'Mater Domini', Catanzaro, Italy.""}, {'ForeName': 'Eugenio', 'Initials': 'E', 'LastName': 'Garofalo', 'Affiliation': ""Department of Surgical and Medical Sciences, University 'Magna Graecia', Catanzaro, Italy.""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Bruni', 'Affiliation': ""Department of Surgical and Medical Sciences, University 'Magna Graecia', Catanzaro, Italy.""}, {'ForeName': 'Patrizia', 'Initials': 'P', 'LastName': 'Doldo', 'Affiliation': ""Department of Clinical and Experimental Medicine, University 'Magna Graecia', Catanzaro, Italy.""}]",Journal of advanced nursing,['10.1111/jan.14516']
2670,32901984,Internet-based support program on parenting outcomes for Chinese primiparous women: Study protocol for a randomized controlled trial.,"AIM


To evaluate the effects of internet-based support program for primiparous women in terms of improving the levels of maternal self-efficacy, social support, and satisfaction; and reducing their postpartum depression symptoms.
DESIGN


A single-blinded, multicentre, randomized, controlled, parallel-group pre-test and repeated post-test design.
METHODS


Based on the self-efficacy theory and the social exchange theory, the internet-based support program has five modules: (a) learning forum of parenting knowledge and skills; (b) communication forum; (c) ask-the-expert forum; (d) baby home forum; and (e) reminder forum. Primiparous women will be recruited in the obstetric wards of two university-affiliated hospitals in China. The participants (N = 258) will be randomly allocated to the intervention group that receive routine care and access to the internet-based support program and the control group that receive routine care during the 3 months postpartum. Maternal self-efficacy, social support, and postpartum depression symptoms will be measured at baseline, immediately after the intervention (post-test 1) and 3 months after the intervention (post-test 2). The study was funded in January 2018 and was ethically approved in May 2020.
DISCUSSION


If the internet-based support program has positive outcomes, it will contribute to the scientific and practical knowledge of nursing interventions to support primiparous women on parenting; and could become the routine health care for health professionals to enhance parenting ability and mental well-being of new mothers.
IMPACT


As the first RCT study on parenting outcomes using a rigorous research design and a theoretical framework in China, this research will contribute to evidence on the effectiveness of using internet platform to support women after childbirth. The results could help to advance research about the use of internet-based intervention methods to improve women's maternal self-efficacy, social support, satisfaction, and to alleviate depression symptoms. Chinese Clinical Trial Registry: ChiCTR2000033154.",2020,"The results could help to advance research about the use of internet-based intervention methods to improve women's maternal self-efficacy, social support, satisfaction, and to alleviate depression symptoms.","['Chinese primiparous women', 'Primiparous women will be recruited in the obstetric wards of two university-affiliated hospitals in China', 'participants (N\xa0=\xa0258', 'primiparous women', 'primiparous women on parenting']","['social exchange theory, the internet-based support program', 'internet-based support program', 'Internet-based support program', 'intervention group that receive routine care and access to the internet-based support program and the control group that receive routine care']","['maternal self-efficacy, social support, and satisfaction', 'Maternal self-efficacy, social support, and postpartum depression symptoms']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0033150', 'cui_str': 'Para 1'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0221074', 'cui_str': 'Postpartum depression'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",258.0,0.062753,"The results could help to advance research about the use of internet-based intervention methods to improve women's maternal self-efficacy, social support, satisfaction, and to alleviate depression symptoms.","[{'ForeName': 'Xujuan', 'Initials': 'X', 'LastName': 'Zheng', 'Affiliation': 'Health Science Centre, Shenzhen University, Shenzhen, Guangdong, China.'}, {'ForeName': 'Lingling', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': 'Health Science Centre, Shenzhen University, Shenzhen, Guangdong, China.'}, {'ForeName': 'Qiyu', 'Initials': 'Q', 'LastName': 'Fang', 'Affiliation': 'Health Science Centre, Shenzhen University, Shenzhen, Guangdong, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Health Science Centre, Shenzhen University, Shenzhen, Guangdong, China.'}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Health Science Centre, Shenzhen University, Shenzhen, Guangdong, China.'}, {'ForeName': 'Xilin', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Health Science Centre, Shenzhen University, Shenzhen, Guangdong, China.'}, {'ForeName': 'Ziwen', 'Initials': 'Z', 'LastName': 'Ye', 'Affiliation': 'Health Science Centre, Shenzhen University, Shenzhen, Guangdong, China.'}, {'ForeName': 'Qun', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Health Science Centre, Shenzhen University, Shenzhen, Guangdong, China.'}]",Journal of advanced nursing,['10.1111/jan.14517']
2671,32902928,Effect of Gluten Ingestion and FODMAP Restriction on Intestinal Epithelial Integrity in Patients with Irritable Bowel Syndrome and Self-Reported Non-Coeliac Gluten Sensitivity.,"SCOPE


Since epithelial barrier dysfunction has been associated with gluten and fermentable oligosaccharide, disaccharide, monosaccharide, and polyols (FODMAPs), the effect of alterations in FODMAP a gluten intake on epithelial barrier function in patients with irritable bowel syndrome (IBS) who self-reported gluten sensitivity.
METHODS AND RESULTS


Circulating concentrations of markers of epithelial injury (syndecan-1 and intestinal fatty acid-binding protein) and bacterial translocation (lipopolysaccharide-binding protein and soluble CD14) are measured while consuming habitual gluten-free diet and during blinded challenges with gluten or placebo on a background of low FODMAP intake. In 33 patients, only syndecan-1 concentrations during their habitual diet are elevated (median 43 ng mL -1  ) compared with 23 ng mL -1  in 49 healthy subjects (p < 0.001). On a low FODMAP diet, symptoms are reduced and levels of syndecan-1 (but not other markers) fell by a median 3335% (p < 0.001) irrespective of whether gluten is present or not.
CONCLUSION


Gluten ingestion has no specific effect on epithelial integrity or symptoms in this cohort, but reducing FODMAP intake concomitantly reduces symptoms and reverses apparent colonic epithelial injury. These findings highlight the heterogeneity of populations self-reporting gluten sensitivity and implicate FODMAPs in colonic injury in IBS.",2020,"On a low FODMAP diet, symptoms were reduced and levels of syndecan-1 (but not other markers) fell by a median 33-35% irrespective of whether gluten was present or not.
","['33 patients with IBS and self-reported', 'Patients with Irritable Bowel Syndrome and Self-reported Non-coeliac Gluten Sensitivity', 'patients with irritable bowel syndrome (IBS) who self-reported gluten sensitivity']","['Gluten Ingestion and Fodmap Restriction', 'placebo']","['Intestinal Epithelial Integrity', 'epithelial integrity or symptoms', 'gluten sensitivity, syndecan-1 concentrations', 'epithelial injury (syndecan-1 and intestinal fatty acid-binding protein) and bacterial translocation (lipopolysaccharide-binding protein and soluble CD14']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C2711053', 'cui_str': 'Non-celiac gluten sensitivity'}, {'cui': 'C0850024', 'cui_str': 'Gluten sensitivity'}]","[{'cui': 'C2362561', 'cui_str': 'Gluten'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0850024', 'cui_str': 'Gluten sensitivity'}, {'cui': 'C0753253', 'cui_str': 'SDC1 protein, human'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0163314', 'cui_str': 'Intestinal Fatty Acid-Binding Protein'}, {'cui': 'C0282583', 'cui_str': 'Bacterial translocation'}, {'cui': 'C0065054', 'cui_str': 'lipopolysaccharide-binding protein'}, {'cui': 'C0108768', 'cui_str': 'Lymphocyte antigen CD14'}]",33.0,0.0743005,"On a low FODMAP diet, symptoms were reduced and levels of syndecan-1 (but not other markers) fell by a median 33-35% irrespective of whether gluten was present or not.
","[{'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Ajamian', 'Affiliation': 'Department of Gastroenterology, Monash University and Alfred Health, Melbourne, Victoria, 3004, Australia.'}, {'ForeName': 'Gennaro', 'Initials': 'G', 'LastName': 'Rosella', 'Affiliation': 'Department of Gastroenterology, Monash University and Alfred Health, Melbourne, Victoria, 3004, Australia.'}, {'ForeName': 'Evan D', 'Initials': 'ED', 'LastName': 'Newnham', 'Affiliation': 'Department of Gastroenterology and Hepatology, Eastern Health, Victoria, 3128, Australia.'}, {'ForeName': 'Jessica R', 'Initials': 'JR', 'LastName': 'Biesiekierski', 'Affiliation': 'Department of Gastroenterology and Hepatology, Eastern Health, Victoria, 3128, Australia.'}, {'ForeName': 'Jane G', 'Initials': 'JG', 'LastName': 'Muir', 'Affiliation': 'Department of Gastroenterology, Monash University and Alfred Health, Melbourne, Victoria, 3004, Australia.'}, {'ForeName': 'Peter R', 'Initials': 'PR', 'LastName': 'Gibson', 'Affiliation': 'Department of Gastroenterology, Monash University and Alfred Health, Melbourne, Victoria, 3004, Australia.'}]",Molecular nutrition & food research,['10.1002/mnfr.201901275']
2672,32897809,Maternal Support Is Protective Against Suicidal Ideation Among a Diverse Cohort of Young Transgender Women.,"Purpose:  We assessed if young transgender women (YTW) with parents who are supportive of their transgender identity had lower odds of having suicidal ideation compared with YTW with unsupportive parents.  Methods:  This study analyzed baseline findings from a diverse sample of 297 sexually active, YTW 16-29 years of age who were enrolled in Project LifeSkills, a randomized controlled HIV prevention intervention efficacy trial in Chicago and Boston, between 2012 and 2015. Bivariate and multivariable logistic regression were used to assess if parental support was associated with a decreased odds of suicidal ideation.  Results:  Nearly one-fifth (18.9%) of YTW reported suicidal ideation at baseline. In our adjusted multivariable model, YTW with supportive mothers had 0.37 (95% confidence interval = 0.15-0.90) times the odds of having suicidal ideation compared with YTW with unsupportive mothers.  Conclusion:  This study found that the odds of suicidal ideation were lower among YTW who had mothers who were supportive of their transgender identity. Our results suggest that parent-focused interventions to improve the relationships between YTW and their parents may lower the odds of YTW having suicidal ideation. Clinical Trial Registration Identifier: NCT01575938.",2020,This study found that the odds of suicidal ideation were lower among YTW who had mothers who were supportive of their transgender identity.,"['diverse sample of 297 sexually active, YTW 16-29 years of age who were enrolled in Project LifeSkills, a randomized controlled HIV prevention intervention efficacy trial in Chicago and Boston, between 2012 and 2015', 'young transgender women (YTW) with parents who are supportive of their transgender identity had lower odds of having suicidal ideation compared with YTW with unsupportive parents']",[],['suicidal ideation'],"[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0241028', 'cui_str': 'Sexually active'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0008044', 'cui_str': 'Chicago'}, {'cui': 'C0006037', 'cui_str': 'Boston'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C1319927', 'cui_str': 'Male-to-female transsexual'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0558141', 'cui_str': 'Transsexual'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0332287', 'cui_str': 'With'}]",[],"[{'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}]",297.0,0.104996,This study found that the odds of suicidal ideation were lower among YTW who had mothers who were supportive of their transgender identity.,"[{'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Jin', 'Affiliation': 'Department of Epidemiology, Brown University School of Public Health, Providence, Rhode Island, USA.'}, {'ForeName': 'Arjee', 'Initials': 'A', 'LastName': 'Restar', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, Rhode Island, USA.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Goedel', 'Affiliation': 'Department of Epidemiology, Brown University School of Public Health, Providence, Rhode Island, USA.'}, {'ForeName': 'Adedotun', 'Initials': 'A', 'LastName': 'Ogunbajo', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, Rhode Island, USA.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Biello', 'Affiliation': 'Department of Epidemiology, Brown University School of Public Health, Providence, Rhode Island, USA.'}, {'ForeName': 'Don', 'Initials': 'D', 'LastName': 'Operario', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, Rhode Island, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Kuhns', 'Affiliation': 'Department of Pediatrics, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA.'}, {'ForeName': 'Sari L', 'Initials': 'SL', 'LastName': 'Reisner', 'Affiliation': ""Division of General Pediatrics, Boston Children's Hospital and Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Garofalo', 'Affiliation': ""Division of Adolescent and Young Adult Medicine, Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois, USA.""}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Mimiaga', 'Affiliation': 'Department of Epidemiology, Brown University School of Public Health, Providence, Rhode Island, USA.'}]",LGBT health,['10.1089/lgbt.2020.0219']
2673,32913797,Psychological and physiological effects of emotion focused training for self-compassion and self-protection.,"Emotion Focused Training for Self-Compassion and Self-Protection (EFT-SCP) is a novel intervention developed on the basis of the latest findings on self-criticism from Emotion-focused therapy and existing programs designed to cultivate compassion. EFTSCP is designed to encourage participants to cultivate self-compassion and protective anger as a way of reducing selfcriticism. Our goal was to investigate the effect of this group-based intervention on self-criticism, self-protection, and self-compassion. A total of 73 students were assigned to the EFT-SCP intervention ( n =19), no-treatment control ( n =34) or to an active control group ( n =20). The intervention group met weekly for 1.5 hours and were instructed to incorporate EFT-SCP tasks into their daily life for 12 weeks. Whilst the no-treatment group did not undergo an intervention, the active control group completed an adapted expressive writing task once a week. In addition to the assessment of heart rate variability during imagery tasks, participants also completed self-reported measures of self-compassion and self-criticism before and after the intervention. Compared with both control groups, the intervention group showed a significant increase in heart rate variability following EFT-SCP (during self-critical imagery, P=.049; probability of superiority was .63, and during self-compassionate imagery P=.007; probability of superiority was .62, both effect sizes were medium) and significant decreases in selfcriticism (Hated Self P=.017; .34 and Inadequate Self P<.001; .33) and self-uncompassionate responding (P<.001; .39). All three effect sizes were small. Participating in EFT-SCP had a positive effect on psychological and physiological outcomes.",2019,"Compared with both control groups, the intervention group showed a significant increase in heart rate variability following EFT-SCP (during self-critical imagery, P=.049; probability of superiority was .63, and during self-compassionate imagery P=.007; probability of superiority was .62, both effect sizes were medium) and significant decreases in selfcriticism (Hated Self P=.017;",['A total of 73 students'],"['EFT-SCP intervention', 'EFTSCP', 'EFT-SCP tasks', 'Emotion Focused Training for Self-Compassion and Self-Protection (EFT-SCP']","['selfcriticism', 'self-criticism, self-protection, and self-compassion', 'self-compassion and self-criticism', 'heart rate variability', 'heart rate variability following EFT-SCP']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1510633', 'cui_str': 'Self-Criticism'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]",73.0,0.0216659,"Compared with both control groups, the intervention group showed a significant increase in heart rate variability following EFT-SCP (during self-critical imagery, P=.049; probability of superiority was .63, and during self-compassionate imagery P=.007; probability of superiority was .62, both effect sizes were medium) and significant decreases in selfcriticism (Hated Self P=.017;","[{'ForeName': 'Júlia', 'Initials': 'J', 'LastName': 'Halamová', 'Affiliation': 'Institute of Applied Psychology, Faculty of Social and Economic Sciences, Comenius University in Bratislava, Bratislava, Slovakia.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Koróniová', 'Affiliation': 'Institute of Applied Psychology, Faculty of Social and Economic Sciences, Comenius University in Bratislava, Bratislava, Slovakia.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Kanovský', 'Affiliation': 'Institute of Social Anthropology, Faculty of Social and Economic Sciences, Comenius University in Bratislava, Bratislava, Slovakia.'}, {'ForeName': 'Mária Kénesy', 'Initials': 'MK', 'LastName': 'Túniyová', 'Affiliation': 'Institute of Experimental Psychology, Center of Social and Psychological Sciences, Slovak Academy of Sciences, Bratislava, Slovakia.'}, {'ForeName': 'Nuriye', 'Initials': 'N', 'LastName': 'Kupeli', 'Affiliation': 'Marie Curie Palliative Care Research Department, Division of Psychiatry, University College London, London, United Kingdom.'}]",Research in psychotherapy (Milano),['10.4081/ripppo.2019.358']
2674,32906842,Development and Evaluation of an Antiviral Agent Medication Adherence Education Program for Patients with Chronic Hepatitis C.,"This study aimed to develop and evaluate a goal attainment theory-based antiviral agent medication adherence education program (AMAEP) for patients with chronic hepatitis C. A nonequivalent control group pretest-posttest design was used. Data were collected from December 2019 to March 2020 from a control group of 35 outpatients and an experimental group of 28 outpatients older than 20 years old who had been diagnosed with chronic hepatitis C. The data analysis included an independent  t -test, a χ 2 -test or Fisher's exact test, a Kolmogorov-Smirnov test, an analysis of covariance, and a Mann-Whitney U test. The results showed the effectiveness of the education program for patients with chronic hepatitis C. There were significant differences between the control group and experimental group in patients' knowledge of chronic hepatitis C (Z = -5.91,  p  < 0.001), medication self-efficacy (Z = -5.02,  p  < 0.001), medication adherence rate ( t  = -3.88,  p  < 0.001), medication misuse behavior (Z = -5.00,  p  < 0.001), and patients' satisfaction with their interaction with healthcare practitioners (Z = -6.61,  p  < 0.001). Therefore, we hope that the education program developed in this study will be utilized as an intervention for patients with chronic hepatitis C and be further developed for other patients with viral hepatitis.",2020,"There were significant differences between the control group and experimental group in patients' knowledge of chronic hepatitis C (Z = -5.91,  p  < 0.001), medication self-efficacy (Z = -5.02,  p  < 0.001), medication adherence rate ( t  = -3.88,  p  < 0.001), medication misuse behavior (Z = -5.00,  p  < 0.001), and patients' satisfaction with their interaction with healthcare practitioners (Z = -6.61,  p  < 0.001).","['Data were collected from December 2019 to March 2020 from a control group of 35 outpatients and an experimental group of 28 outpatients older than 20 years old who had been diagnosed with chronic hepatitis C', 'Patients with Chronic Hepatitis C', 'patients with chronic hepatitis C and be further developed for other patients with viral hepatitis', 'patients with chronic hepatitis C']","['Antiviral Agent Medication Adherence Education Program', 'goal attainment theory-based antiviral agent medication adherence education program (AMAEP']","['medication adherence rate', 'medication misuse behavior', 'medication self-efficacy', 'knowledge of chronic hepatitis C']","[{'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0524910', 'cui_str': 'Chronic hepatitis C'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042721', 'cui_str': 'Viral hepatitis'}]","[{'cui': 'C0003451', 'cui_str': 'Antiviral'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0450442', 'cui_str': 'Agent'}]","[{'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0036600', 'cui_str': 'Self-medication'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0524910', 'cui_str': 'Chronic hepatitis C'}]",28.0,0.028512,"There were significant differences between the control group and experimental group in patients' knowledge of chronic hepatitis C (Z = -5.91,  p  < 0.001), medication self-efficacy (Z = -5.02,  p  < 0.001), medication adherence rate ( t  = -3.88,  p  < 0.001), medication misuse behavior (Z = -5.00,  p  < 0.001), and patients' satisfaction with their interaction with healthcare practitioners (Z = -6.61,  p  < 0.001).","[{'ForeName': 'Hoo Jeung', 'Initials': 'HJ', 'LastName': 'Cho', 'Affiliation': 'Department of Nursing, Pukyong National University, Busan 48513, Korea.'}, {'ForeName': 'Euna', 'Initials': 'E', 'LastName': 'Park', 'Affiliation': 'Department of Nursing, Pukyong National University, Busan 48513, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17186518']
2675,32908282,Insulin dose optimization using an automated artificial intelligence-based decision support system in youths with type 1 diabetes.,"Despite the increasing adoption of insulin pumps and continuous glucose monitoring devices, most people with type 1 diabetes do not achieve their glycemic goals 1 . This could be related to a lack of expertise or inadequate time for clinicians to analyze complex sensor-augmented pump data. We tested whether frequent insulin dose adjustments guided by an automated artificial intelligence-based decision support system (AI-DSS) is as effective and safe as those guided by physicians in controlling glucose levels. ADVICE4U was a six-month, multicenter, multinational, parallel, randomized controlled, non-inferiority trial in 108 participants with type 1 diabetes, aged 10-21 years and using insulin pump therapy (ClinicalTrials.gov no. NCT03003806). Participants were randomized 1:1 to receive remote insulin dose adjustment every three weeks guided by either an AI-DSS, (AI-DSS arm, n = 54) or by physicians (physician arm, n = 54). The results for the primary efficacy measure-the percentage of time spent within the target glucose range (70-180 mg dl -1  (3.9-10.0 mmol l -1 ))-in the AI-DSS arm were statistically non-inferior to those in the physician arm (50.2 ± 11.1% versus 51.6 ± 11.3%, respectively, P < 1 × 10 -7 ). The percentage of readings below 54 mg dl -1  (<3.0 mmol l -1 ) within the AI-DSS arm was statistically non-inferior to that in the physician arm (1.3 ± 1.4% versus 1.0 ± 0.9%, respectively, P < 0.0001). Three severe adverse events related to diabetes (two severe hypoglycemia, one diabetic ketoacidosis) were reported in the physician arm and none in the AI-DSS arm. In conclusion, use of an automated decision support tool for optimizing insulin pump settings was non-inferior to intensive insulin titration provided by physicians from specialized academic diabetes centers.",2020,"In conclusion, use of an automated decision support tool for optimizing insulin pump settings was non-inferior to intensive insulin titration provided by physicians from specialized academic diabetes centers.","['youths with type 1 diabetes', '108 participants with type 1 diabetes, aged 10-21 years and using insulin pump therapy (ClinicalTrials.gov no']","['Insulin dose optimization using an automated artificial intelligence-based decision support system', 'remote insulin dose adjustment every three weeks guided by either an AI-DSS', 'frequent insulin dose adjustments guided by an automated artificial intelligence-based decision support system (AI-DSS']","['percentage of time spent within the target glucose range', 'severe hypoglycemia, one diabetic ketoacidosis']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0240016', 'cui_str': 'Insulin used'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0003916', 'cui_str': 'Computer Reasoning'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0870393', 'cui_str': 'Decision support tool'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0585333', 'cui_str': 'Triweekly'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C4728082', 'cui_str': 'Severe hypoglycaemia'}, {'cui': 'C0011880', 'cui_str': 'Diabetic ketoacidosis'}]",108.0,0.0687685,"In conclusion, use of an automated decision support tool for optimizing insulin pump settings was non-inferior to intensive insulin titration provided by physicians from specialized academic diabetes centers.","[{'ForeName': 'Revital', 'Initials': 'R', 'LastName': 'Nimri', 'Affiliation': ""The Jesse Z and Sara Lea Shafer Institute for Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children's Medical Center of Israel, Petah Tikva, Israel.""}, {'ForeName': 'Tadej', 'Initials': 'T', 'LastName': 'Battelino', 'Affiliation': ""Department of Endocrinology, Diabetes and Metabolic Diseases, UMC-University Children's Hospital Ljubljana, and Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia.""}, {'ForeName': 'Lori M', 'Initials': 'LM', 'LastName': 'Laffel', 'Affiliation': 'Joslin Diabetes Center, One Joslin Place, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Slover', 'Affiliation': 'Barbara Davis Center for Childhood Diabetes, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Desmond', 'Initials': 'D', 'LastName': 'Schatz', 'Affiliation': 'Department of Pediatrics, College of Medicine, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Stuart A', 'Initials': 'SA', 'LastName': 'Weinzimer', 'Affiliation': 'Pediatric Endocrinology & Diabetes, Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Klemen', 'Initials': 'K', 'LastName': 'Dovc', 'Affiliation': ""Department of Endocrinology, Diabetes and Metabolic Diseases, UMC-University Children's Hospital Ljubljana, and Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia.""}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Danne', 'Affiliation': ""Diabetes Center for Children and Adolescents, Children's Hospital AUF DER BULT, Hannover, Germany.""}, {'ForeName': 'Moshe', 'Initials': 'M', 'LastName': 'Phillip', 'Affiliation': ""The Jesse Z and Sara Lea Shafer Institute for Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children's Medical Center of Israel, Petah Tikva, Israel. mosheph@tauex.tau.ac.il.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Nature medicine,['10.1038/s41591-020-1045-7']
2676,32911132,A brief telephone-delivered peer intervention to encourage enrollment in medication for opioid use disorder in individuals surviving an opioid overdose: Results from a randomized pilot trial.,"BACKGROUND


Medication for opioid use disorder (MOUD) can decrease the risk of opioid overdose (OOD) in individuals with opioid use disorder. Peer recovery support services (PRSS) are increasingly used to promote MOUD engagement but evidence of their efficacy is limited. This study's objective was to evaluate a single 20-minute telephone-delivered PRSS intervention for increasing MOUD enrollment and decreasing recurring OODs.
METHOD


This single-site, randomized controlled pilot trial enrolled adults, primarily recruited from a syringe service program, with an opioid-positive urine drug screen (UDS) reporting having been treated for an OOD within the past 6 months. Participants (N = 80) were randomized to PRSS (n = 40) or Control (n = 40) condition with all participants receiving personally-tailored OOD education and naloxone. Outcome measures obtained at 3 (n = 66), 6 (n = 58), and 12 (n = 44) months post-randomization included verified MOUD enrollment (primary), self-reported OOD, and opioid use assessed by self-report and UDS.
RESULTS


Through 12-month follow-up, 32.5 % of PRSS, compared to 17.5 % of Control participants enrolled in MOUD (X 2  = 2.4, p = 0.12; odds ratio = 2.27 (0.79-6.49)). PRSS participants were significantly less likely to have experienced an OOD through 12-month follow-up (12.5 % of PRSS participants, 32.5 % of Control, p = 0.03). No significant treatment effect was found for opioid use through 12-month follow-up as measured by either opioid-positive UDSs or self-reported past month opioid use days. Based on self-report, PRSS had good acceptability for both the interventionists and participants.
CONCLUSIONS


The results suggest that further development and testing of this PRSS telephone intervention to encourage MOUD enrollment and reduce OOD may be warranted.",2020,No significant treatment effect was found for opioid use through 12-month follow-up as measured by either opioid-positive UDSs or self-reported past month opioid use days.,"['individuals with opioid use disorder', 'Participants (N = 80', 'individuals surviving an opioid overdose', 'enrolled adults, primarily recruited from a syringe service program, with an opioid-positive urine drug screen (UDS) reporting having been treated for an OOD within the past 6 months']","['PRSS', 'PRSS telephone intervention', 'Control (n = 40) condition with all participants receiving personally-tailored OOD education and naloxone', 'Peer recovery support services (PRSS', 'telephone-delivered PRSS intervention', 'telephone-delivered peer intervention']","['verified MOUD enrollment (primary), self-reported OOD, and opioid use assessed by self-report and UDS']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0029944', 'cui_str': 'Drug overdose'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0039142', 'cui_str': 'Syringe'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0743300', 'cui_str': 'Urine drug screen positive'}, {'cui': 'C0202274', 'cui_str': 'Urine drug screening'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0029944', 'cui_str': 'Drug overdose'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0027358', 'cui_str': 'Naloxone'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0029944', 'cui_str': 'Drug overdose'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0202274', 'cui_str': 'Urine drug screening'}]",80.0,0.0748964,No significant treatment effect was found for opioid use through 12-month follow-up as measured by either opioid-positive UDSs or self-reported past month opioid use days.,"[{'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Winhusen', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH, 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3230 Eden Ave, Cincinnati, OH 45267, USA. Electronic address: winhusen@carc.uc.edu.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Wilder', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH, 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3230 Eden Ave, Cincinnati, OH 45267, USA.'}, {'ForeName': 'Frankie', 'Initials': 'F', 'LastName': 'Kropp', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH, 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3230 Eden Ave, Cincinnati, OH 45267, USA.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Theobald', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH, 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3230 Eden Ave, Cincinnati, OH 45267, USA.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Lyons', 'Affiliation': 'Department of Emergency Medicine, University of Cincinnati College of Medicine, 231 Albert Sabin Way, Cincinnati, OH, 45267, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Lewis', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH, 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3230 Eden Ave, Cincinnati, OH 45267, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108270']
2677,32911210,Factors affecti̇ng health-promoting behavi̇ors i̇n nursi̇ng students: A structural equation modeling approach.,"BACKGROUND


The purpose of this study is to evaluate the effectiveness of the Mindfulness-based Stress Reduction program applied to a sample of Turkish nursing students.
METHOD


The study was designed as a randomized controlled trial. Program sessions of 90-95 minutes were given twice a week for 12 weeks. The data were collected using the Nursing Education Stress Scale, the Mindfulness Scale, and the Stress Management Styles Scale.
RESULTS


A statistically significant difference was found in the mean post-test and mean follow-up scores obtained by the control group and the experimental group on the Nursing Education Stress Scale and its sub-dimensions. On the Mindfulness Scale, a statistically significant difference was found between the mean pre-test and post-test scores obtained by the experiment and control groups.
CONCLUSION


The results derived from this study suggest that the mindfulness-based stress reduction program is effective in reducing the stress experienced by students during nursing education, increasing their mindfulness, strengthening their coping mechanisms for stress, increasing their use of self-confident and optimistic approaches, and decreasing their use of the helpless approach.",2020,A statistically significant difference was found in the mean post-test and mean follow-up scores obtained by the control group and the experimental group on the Nursing Education Stress Scale and its sub-dimensions.,"['Factors affecti̇ng health-promoti?ng behavi̇ors i̇n nursi̇ng students', 'Turkish nursing students']","['mindfulness-based stress reduction program', 'Mindfulness-based Stress Reduction program']","['Nursing Education Stress Scale, the Mindfulness Scale, and the Stress Management Styles Scale', 'Nursing Education Stress Scale']","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0041402', 'cui_str': 'Turkish language'}, {'cui': 'C0038496', 'cui_str': 'Student nurse'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0013636', 'cui_str': 'Nursing Education'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0150788', 'cui_str': 'Stress management'}]",95.0,0.0107001,A statistically significant difference was found in the mean post-test and mean follow-up scores obtained by the control group and the experimental group on the Nursing Education Stress Scale and its sub-dimensions.,"[{'ForeName': 'N', 'Initials': 'N', 'LastName': 'Yıldırım Şişman', 'Affiliation': 'DuzceUniversity, Facultyof Health Sciences, Department of Nursing, Duzce, Turkey. Electronic address: nuriyeyildirim@duzce.edu.tr.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Karaca', 'Affiliation': 'DuzceUniversity, Facultyof Health Sciences, Department of Nursing, Duzce, Turkey. Electronic address: ayselkaraca@duzce.edu.tr.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Cangür', 'Affiliation': 'DuzceUniversity, Faculty of Medicine, Department of Biostatistics and Medical Informatics, Duzce, Turkey. Electronic address: sengulcangur@duzce.edu.tr.'}]",Nurse education in practice,['10.1016/j.nepr.2020.102880']
2678,32917645,Inflammation Modulation by Vitamin D and Calcium in the Morphologically Normal Colorectal Mucosa of Patients with Colorectal Adenoma in a Clinical Trial.,"Increased COX-2 and decreased 15-hydroxyprostaglandin dehydrogenase (15-HPGD) expression promote prostaglandin-mediated inflammation and colorectal carcinogenesis. Experimental studies suggest that vitamin D and calcium may inhibit these pathways, but their effects on colorectal tissue COX-2 and 15-HPGD expression in humans are unknown. We tested the effects of supplemental vitamin D (1,000 IU/day) and/or calcium (1,200 mg/day) on COX-2 and 15-HPGD expression in the morphologically normal rectal mucosa from 62 paients with colorectal adenoma in a placebo-controlled chemoprevention trial. We measured biomarker expression using automated IHC and quantitative image analysis at baseline and 1-year follow-up, and assessed treatment effects using mixed linear models. The primary outcome was the COX-2/15-HPGD expression ratio, because these enzymes function as physiologic antagonists. After 1 year of treatment, the mean COX-2/15-HPGD expression ratio in full-length crypts proportionately decreased 47% in the vitamin D group ( P  = 0.001), 46% in the calcium group ( P  = 0.002), and 34% in the calcium + vitamin D group ( P  = 0.03), relative to the placebo group. Among individuals with the functional vitamin D-binding protein isoform DBP2 ( GC  rs4588*A), the COX-2/15-HPDG ratio decreased 70% ( P  = 0.0006), 75% ( P  = 0.0002), and 60% ( P  = 0.006) in the vitamin D, calcium, and combined supplementation groups, respectively, relative to placebo. These results show that vitamin D and calcium favorably modulate the balance of expression of COX-2 and 15-HPGD-biomarkers of inflammation that are strongly linked to colorectal carcinogenesis-in the normal-appearing colorectal mucosa of patients with colorectal adenoma (perhaps especially those with the DBP2 isoform).",2020,"After 1 year of treatment, the mean COX-2/15-HPGD expression ratio in full-length crypts proportionately decreased 47% in the vitamin D group (P = 0.001), 46% in the calcium group (P = 0.002), and 34% in the calcium + vitamin D group (P = 0.03), relative to the placebo group.",['62 colorectal adenoma patients in a placebo-controlled chemoprevention trial'],"['vitamin D', 'Vitamin D and Calcium', 'calcium + vitamin D', 'vitamin D and calcium', 'supplemental vitamin D (1,000 I.U./day) and/or calcium']","['Increased cyclooxygenase-2 (COX-2) and decreased 15-hydroxyprostaglandin dehydrogenase (15-HPGD) expression promote prostaglandin-mediated inflammation and colorectal carcinogenesis', 'COX-2 and 15-HPGD expression', 'COX-2/15-HPGD expression ratio, since these enzymes function as physiologic antagonists', 'COX-2/15-HPDG ratio', 'balance of expression of COX-2 and 15-HPGD-biomarkers of inflammation', 'mean COX-2/15-HPGD expression ratio in full-length crypts']","[{'cui': 'C1302401', 'cui_str': 'Adenoma of large intestine'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0282515', 'cui_str': 'Prophylactic chemotherapy'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0719107', 'cui_str': 'Calcium and vitamin D product'}]","[{'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0387583', 'cui_str': 'Cyclooxygenase 2'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0044894', 'cui_str': '15-hydroxyprostaglandin dehydrogenase (NAD^+^)'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0033554', 'cui_str': 'Prostaglandin'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C0596263', 'cui_str': 'Oncogenesis'}, {'cui': 'C0033551', 'cui_str': 'Prostaglandin synthase'}, {'cui': 'C0020390', 'cui_str': 'Hydroxyprostaglandin Dehydrogenase'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0014442', 'cui_str': 'Enzyme'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1444754', 'cui_str': 'Length'}]",,0.138362,"After 1 year of treatment, the mean COX-2/15-HPGD expression ratio in full-length crypts proportionately decreased 47% in the vitamin D group (P = 0.001), 46% in the calcium group (P = 0.002), and 34% in the calcium + vitamin D group (P = 0.03), relative to the placebo group.","[{'ForeName': 'David Corley', 'Initials': 'DC', 'LastName': 'Gibbs', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Veronika', 'Initials': 'V', 'LastName': 'Fedirko', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, Georgia.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Baron', 'Affiliation': 'University of North Carolina School of Medicine, Chapel Hill, North Carolina.'}, {'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Barry', 'Affiliation': 'Department of Epidemiology, Geisel School of Medicine at Dartmouth, Lebanon, New Hampshire.'}, {'ForeName': 'W Dana', 'Initials': 'WD', 'LastName': 'Flanders', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Marjorie L', 'Initials': 'ML', 'LastName': 'McCullough', 'Affiliation': 'American Cancer Society, Atlanta, Georgia.'}, {'ForeName': 'Rami', 'Initials': 'R', 'LastName': 'Yacoub', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Tapasya', 'Initials': 'T', 'LastName': 'Raavi', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Robin E', 'Initials': 'RE', 'LastName': 'Rutherford', 'Affiliation': 'Division of Digestive Diseases, Department of Medicine, Emory University, Atlanta, Georgia.'}, {'ForeName': 'March E', 'Initials': 'ME', 'LastName': 'Seabrook', 'Affiliation': 'Consultants in Gastroenterology, West Columbia, South Carolina.'}, {'ForeName': 'Roberd M', 'Initials': 'RM', 'LastName': 'Bostick', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, Georgia. rmbosti@emory.edu.'}]","Cancer prevention research (Philadelphia, Pa.)",['10.1158/1940-6207.CAPR-20-0140']
2679,32920297,Postprandial factor VII activation does not increase plasma concentrations of prothrombin fragment 1 + 2 in patients with morbid obesity.,"INTRODUCTION


Increased postprandial factor VII activation is observed after high-fat meals, but is not accompanied by thrombin formation in normal weight individuals. Obesity is associated with a higher circulating concentration of tissue factor (TF) and postprandial uptake of lipopolysaccharide (LPS), and this may increase thrombin formation after high-fat meals. We therefore compared postprandial effects of high-fat meals and low-fat meals on biomarkers of coagulation activation in patients with morbid obesity and investigated whether the response was associated with the gut bacteria composition.
MATERIALS AND METHODS


A controlled cross-over study was conducted in obese patients (15 women, 5 men, mean BMI = 44.1 kg/m 2 ), where high-fat meals (67 E% fat) and low-fat meals (16 E% fat) were served at 8:15 and 10:00 in a random order on two study days within one week. Blood samples were collected at 08:00 (fasting), 12:00, and 14:00 and analysed for triglycerides, activated FVII (FVIIa), TF, FVIIa-antithrombin (FVIIa-AT), prothrombin fragment 1 + 2 (F1+2), and TF pathway inhibitor (TFPI). The gut bacteria composition, measured as gram-negative bacteria and diversity, was analysed in faecal samples.
RESULTS


Triglycerides, FVIIa, and FVIIa-AT increased significantly after high-fat meals, whereas F1 + 2 decreased equally and significantly over time after both meals. There were no significant changes in TF and TFPI over time. The postprandial changes in F1 + 2 and TFPI after high-fat meals were negatively correlated with diversity.
CONCLUSIONS


Increased postprandial FVIIa is not accompanied by thrombin formation four hours after high-fat meals in patients with morbid obesity, possibly due to FVIIa-inhibition by AT.",2020,"Obesity is associated with a higher circulating concentration of tissue factor (TF) and postprandial uptake of lipopolysaccharide (LPS), and this may increase thrombin formation after high-fat meals.","['patients with morbid obesity', 'obese patients (15 women, 5 men, mean BMI\xa0', 'normal weight individuals']",['high-fat meals and low-fat meals'],"['Triglycerides, FVIIa, and FVIIa-AT', 'triglycerides, activated FVII (FVIIa), TF, FVIIa-antithrombin (FVIIa-AT), prothrombin fragment 1\xa0+\xa02 (F1+2), and TF pathway inhibitor (TFPI', 'Blood samples', 'postprandial changes', 'gut bacteria composition', 'TF and TFPI', 'thrombin formation', 'circulating concentration of tissue factor (TF) and postprandial uptake of lipopolysaccharide (LPS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028756', 'cui_str': 'Morbid obesity'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C2712185', 'cui_str': 'Normal weight'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0242970', 'cui_str': 'Low fat diet'}]","[{'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0003438', 'cui_str': 'Antithrombin III'}, {'cui': 'C0040048', 'cui_str': 'Thromboplastin'}, {'cui': 'C0072436', 'cui_str': 'Prothrombin fragment 1.2'}, {'cui': 'C0332255', 'cui_str': 'Fragment of'}, {'cui': 'C0164707', 'cui_str': 'Tissue factor pathway inhibitor'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0040018', 'cui_str': 'Thrombin'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0023810', 'cui_str': 'Lipopolysaccharide'}]",,0.0190304,"Obesity is associated with a higher circulating concentration of tissue factor (TF) and postprandial uptake of lipopolysaccharide (LPS), and this may increase thrombin formation after high-fat meals.","[{'ForeName': 'Line Espenhain', 'Initials': 'LE', 'LastName': 'Landgrebe', 'Affiliation': 'Unit for Thrombosis Research, Department of Clinical Biochemistry, University Hospital of Southern Denmark, Esbjerg, Denmark; Department of Regional Health Research, University of Southern Denmark, Denmark; OPEN, Odense Patient data Explorative Network, Odense University Hospital, Odense, Denmark. Electronic address: Line.Espenhain.Landgrebe@rsyd.dk.'}, {'ForeName': 'Claus Bogh', 'Initials': 'CB', 'LastName': 'Juhl', 'Affiliation': 'Department of Regional Health Research, University of Southern Denmark, Denmark; Department of Medicine, Section of Endocrinology, University Hospital of Southern Denmark, Esbjerg, Denmark; Steno Diabetes Center Odense, Denmark.'}, {'ForeName': 'Vibeke', 'Initials': 'V', 'LastName': 'Andersen', 'Affiliation': 'Department of Regional Health Research, University of Southern Denmark, Denmark; Focused Research Unit for Molecular Diagnostic and Clinical Research, University Hospital of Southern Denmark, Aabenraa, Denmark; Institute of Molecular Medicine, University of Southern Denmark, Denmark.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Moitinho-Silva', 'Affiliation': 'Institute of Clinical Molecular Biology, Christian-Albrechts-University of Kiel, Kiel, Germany; Department of Dermatology, Venereology and Allergy, University Hospital Schleswig-Holstein, Campus Kiel, Germany.'}, {'ForeName': 'Corinna', 'Initials': 'C', 'LastName': 'Bang', 'Affiliation': 'Institute of Clinical Molecular Biology, Christian-Albrechts-University of Kiel, Kiel, Germany.'}, {'ForeName': 'Else Marie', 'Initials': 'EM', 'LastName': 'Bladbjerg', 'Affiliation': 'Unit for Thrombosis Research, Department of Clinical Biochemistry, University Hospital of Southern Denmark, Esbjerg, Denmark; Department of Regional Health Research, University of Southern Denmark, Denmark.'}]",Thrombosis research,['10.1016/j.thromres.2020.08.044']
2680,32681911,Effects of Induced Astigmatism on Spectral Domain-OCT Angiography Quantitative Metrics.,"PURPOSE


To analyze the effect of induced astigmatism on en-face spectral-domain optical coherence tomography angiography quantitative metrics.
DESIGN


Prospective crossover study.
METHODS


Normal eyes without astigmatism and with 0.75, 1.75, and 2.75 diopters (D) of with-the-rule (WTR) astigmatism were imaged using a 3 × 3-mm scan pattern SD-OCTA CIRRUS 5000 HD-OCT with AngioPlex (Carl Zeiss Meditec, Dublin, CA, USA). Quantitative parameters, including foveal avascular zone metrics, parafoveal vessel length density (VD), and perfusion density (PD) were corrected for magnification secondary to axial length and analyzed. Univariate linear regressions were performed within each eye to correlate quantitative metrics to the level of an induced astigmatic cylinder.
RESULTS


Fifteen eyes from 15 patients were imaged. Every 1-D increase in induced WTR astigmatism was associated with a statistically significant decrease in VD and PD within all Early Treatment Diabetic Retinopathy Study inner ring quadrants; however, especially more so nasally (VD: 0.63; P < .001; PD: 0.0089; P = .001). For every 1-D increase in induced astigmatism, the resulting decrease in the inner ring superior quadrant was 12% greater for VD and 16% greater for PD versus that in the inferior quadrant. The resulting decrease in the inner ring nasal quadrant was 40% greater for VD and 48% greater for PD versus that in the temporal quadrant.
CONCLUSIONS


Increasing levels of induced WTR astigmatism correlated with globally diminishing VD and PD, was more symmetrical for vertical than horizontal quadrants, and was most pronounced nasally. This may be due to a high prevalence of horizontally oriented vessels nasally and the horizontal optical defocus induced by WTR astigmatism.",2020,"Every 1-D increase in induced WTR astigmatism was associated with a statistically significant decrease in VD and PD within all Early Treatment Diabetic Retinopathy Study inner ring quadrants; however, especially more so nasally (VD: 0.63; P < .001; PD: 0.0089; P = .001).","['Fifteen eyes from 15 patients were imaged', 'Normal eyes without astigmatism and with 0.75, 1.75, and 2.75 diopters (D) of with-the-rule (WTR) astigmatism were imaged using a']","['Induced Astigmatism', '3\xa0× 3-mm scan pattern SD-OCTA CIRRUS 5000 HD-OCT with AngioPlex (Carl Zeiss Meditec, Dublin, CA, USA']","['VD and PD', 'foveal avascular zone metrics, parafoveal vessel length density (VD), and perfusion density (PD', 'inner ring nasal quadrant', 'Spectral Domain-OCT Angiography Quantitative Metrics', 'induced WTR astigmatism']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0004106', 'cui_str': 'Astigmatism'}, {'cui': 'C4068882', 'cui_str': '0.75'}, {'cui': 'C4517514', 'cui_str': '1.75'}, {'cui': 'C4517639', 'cui_str': '2.75'}, {'cui': 'C0439484', 'cui_str': 'Diopters'}, {'cui': 'C0522637', 'cui_str': 'Measuring ruler'}]","[{'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0004106', 'cui_str': 'Astigmatism'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C4319610', 'cui_str': '5000'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C0454777', 'cui_str': 'Dublin'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}]","[{'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C1275950', 'cui_str': 'Foveal avascular zone'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0442137', 'cui_str': 'Parafoveal'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0521164', 'cui_str': 'Annular shape'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C1719796', 'cui_str': 'With-the-rule astigmatism'}]",15.0,0.026434,"Every 1-D increase in induced WTR astigmatism was associated with a statistically significant decrease in VD and PD within all Early Treatment Diabetic Retinopathy Study inner ring quadrants; however, especially more so nasally (VD: 0.63; P < .001; PD: 0.0089; P = .001).","[{'ForeName': 'Jesse J', 'Initials': 'JJ', 'LastName': 'Jung', 'Affiliation': 'East Bay Retina Consultants, Inc., Oakland, California, USA; Department of Ophthalmology, Universtiy of California, San Francisco, San Francisco, California, USA. Electronic address: jung.jesse@gmail.com.'}, {'ForeName': 'Yu Qiang', 'Initials': 'YQ', 'LastName': 'Soh', 'Affiliation': 'Singapore Eye Research Institute, Singapore National Eye Centre, Duke-NUS Medical School, Singapore, Singapore.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Sha', 'Affiliation': 'Carl Zeiss Meditec, Inc., Dublin, California, USA; Silicon Valley Eyecare Optometry, Santa Clara, California, USA.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Yu', 'Affiliation': 'Carl Zeiss Meditec, Inc., Dublin, California, USA.'}, {'ForeName': 'Mary K', 'Initials': 'MK', 'LastName': 'Durbin', 'Affiliation': 'Carl Zeiss Meditec, Inc., Dublin, California, USA.'}, {'ForeName': 'Quan V', 'Initials': 'QV', 'LastName': 'Hoang', 'Affiliation': 'Singapore Eye Research Institute, Singapore National Eye Centre, Duke-NUS Medical School, Singapore, Singapore; Department of Ophthalmology, Edward S. Harkness Eye Institute, Columbia College of Physicians and Surgeons, New York, New York, USA.'}]",American journal of ophthalmology,['10.1016/j.ajo.2020.07.005']
2681,32899107,The Effect of Resistance Exercise Intensity on Acute Hyperglycemia in Young Adult Males.,"The purpose of this study was to examine the effect of resistance exercise (RE) intensity on acute hyperglycemia, in young adult males. Thirteen males (age 23.43 ± 2.18 years, height 175.16 ± 10.44 cm, weight 77.02 ± 8.91 kg, body fat 20 ± 0.03%) participated in three randomized testing sessions, each separated by 96 h. The three testing conditions were: control (CON; induction of hyperglycemia with no-exercise), high (HI; induction of hyperglycemia followed by high-intensity RE: 5 × 4, 90% 1-repetition maximum (1-RM)), and moderate (MO; induction of hyperglycemia followed by low-intensity RE: 3 × 14, 65% 1-RM). In all three testing conditions, participants orally ingested a D100 (100 g/10 oz) glucose beverage at a dosage of 2 g glucose/kg body weight and capillary blood was obtained for plasma glucose and insulin analysis at 0 (fasting), 30, 60, 90 and 120 min, following glucose ingestion. At 30-min post-ingestion in the HI and MO conditions, participants began the respective RE protocols. Acute hyperglycemia was achieved throughout all three 2-h testing conditions; mean 2-h plasma glucose levels during CON (7.1 ± 1.3 mmol∙L -1 ), MO (7.5 ± 0.6 mmol∙L -1 ) and HI (8.2 ± 1.9 mmol∙L -1 ) were all significantly ( p  < 0.05) greater than mean fasting plasma glucose (5.6 ± 0.46 mmol∙L -1 ). Plasma glucose and insulin did not differ ( p  < 0.05) between treatment conditions at any times points over the 120 min, however, 2-h glucose area under the curve in the HI condition was significantly greater ( p  < 0.05) than CON and MO. In conclusion, this study indicates that hyperglycemia, induced prior to RE, may be exacerbated by high-intensity RE.",2020,"Plasma glucose and insulin did not differ ( p  < 0.05) between treatment conditions at any times points over the 120 min, however, 2-h glucose area under the curve in the HI condition was significantly greater ( p  < 0.05) than CON and MO.","['Young Adult Males', 'Thirteen males (age 23.43 ± 2.18 years, height 175.16 ± 10.44 cm, weight 77.02 ± 8.91 kg, body fat 20 ± 0.03%) participated in three randomized testing sessions, each separated by 96 h', 'young adult males']","['Resistance Exercise Intensity', 'resistance exercise (RE) intensity', 'control (CON; induction of hyperglycemia with no-exercise), high (HI; induction of hyperglycemia followed by high-intensity RE']","['2-h glucose area under the curve in the HI condition', 'Acute Hyperglycemia', 'Plasma glucose and insulin', 'Acute hyperglycemia', 'mean fasting plasma glucose', 'plasma glucose levels']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C4517402', 'cui_str': '0.03'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0443299', 'cui_str': 'Separate'}]","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}]","[{'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0342301', 'cui_str': 'Acute hyperglycemia'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0280633,"Plasma glucose and insulin did not differ ( p  < 0.05) between treatment conditions at any times points over the 120 min, however, 2-h glucose area under the curve in the HI condition was significantly greater ( p  < 0.05) than CON and MO.","[{'ForeName': 'Evan E', 'Initials': 'EE', 'LastName': 'Schick', 'Affiliation': 'Physiology of Exercise and Sport Laboratory, California State University, Long Beach, CA 90840, USA.'}, {'ForeName': 'Luis E', 'Initials': 'LE', 'LastName': 'Segura', 'Affiliation': 'Physiology of Exercise and Sport Laboratory, California State University, Long Beach, CA 90840, USA.'}, {'ForeName': 'Shayán', 'Initials': 'S', 'LastName': 'Emamjomeh', 'Affiliation': 'Physiology of Exercise and Sport Laboratory, California State University, Long Beach, CA 90840, USA.'}, {'ForeName': 'Joshua A', 'Initials': 'JA', 'LastName': 'Cotter', 'Affiliation': 'Physiology of Exercise and Sport Laboratory, California State University, Long Beach, CA 90840, USA.'}]","Sports (Basel, Switzerland)",['10.3390/sports8090121']
2682,32900535,Pharmacokinetic and Glucodynamic Responses of Ultra Rapid Lispro vs Lispro Across a Clinically Relevant Range of Subcutaneous Doses in Healthy Subjects.,"PURPOSE


Ultra rapid lispro (URLi) is a novel insulin lispro formulation developed to more closely match physiological insulin secretion and improve postprandial glucose control. This study compared the pharmacokinetic and glucodynamic parameters of URLi and Lispro (Humalog®) at 3 dose levels in healthy subjects.
METHODS


This randomized, 6-period, subject- and investigator-blind, crossover study included 42 healthy subjects. At each period, subjects received a single subcutaneous dose of 7, 15, or 30 U of URLi or Lispro followed by a 10-h automated euglycemic clamp. Insulin lispro and blood glucose concentrations were measured.
FINDINGS


Across all 3 doses, insulin lispro appeared in the serum 2-5 min faster, and exposure was 6- to 8-fold greater in the first 15 min, with URLi versus Lispro. Exposure beyond 3 h postdose was 45%-52% lower, and duration of exposure was 67-86 min shorter with URLi versus Lispro for all dose levels. Onset of insulin action was 7-9 min faster and insulin action was ~3-fold greater in the first 30 min with URLi versus Lispro across the dose levels. Insulin action beyond 4 h was reduced by 32%-45%, and duration of action was reduced by 47-67 min, with URLi versus Lispro for all 3 dose levels. Overall exposure and total glucose infused were similar between URLi and Lispro at each dose level. Dose proportionality was observed for maximum and overall exposure after URLi. Less than dose-proportional increases in maximum and total glucose infused were observed and were similar for both URLi and Lispro.
IMPLICATIONS


URLi exhibited ultra-rapid pharmacokinetic and glucodynamic parameters across all 3 dose levels studied and exhibited dose-proportional increases in exposure in healthy subjects. ClinicalTrials.gov identifier: NCT03286751.",2020,"Less than dose-proportional increases in maximum and total glucose infused were observed and were similar for both URLi and Lispro.
","['42 healthy subjects', 'healthy subjects', 'Healthy Subjects']","['URLi and Lispro (Humalog®', 'URLi or Lispro followed by a 10-h automated euglycemic clamp', 'Ultra Rapid Lispro (URLi) vs Lispro (Humalog®', 'Ultra rapid lispro (URLi', 'URLi versus Lispro']","['duration of action', 'Insulin action beyond 4\xa0h', 'duration of exposure', 'Insulin lispro and blood glucose concentrations', 'insulin lispro', 'Overall exposure and total glucose', 'maximum and total glucose', 'Onset of insulin action', 'insulin action']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0293359', 'cui_str': 'Insulin Lispro'}, {'cui': 'C0528249', 'cui_str': 'Humalog'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0052080', 'cui_str': 'antineoplaston A10'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0079318', 'cui_str': 'Euglycaemic Clamp'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0293359', 'cui_str': 'Insulin Lispro'}, {'cui': 'C2585282', 'cui_str': 'Blood glucose concentration'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}]",42.0,0.0551131,"Less than dose-proportional increases in maximum and total glucose infused were observed and were similar for both URLi and Lispro.
","[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Leohr', 'Affiliation': 'Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA. Electronic address: leohr_jennifer_k@lilly.com.'}, {'ForeName': 'Mary Anne', 'Initials': 'MA', 'LastName': 'Dellva', 'Affiliation': 'Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'LaBell', 'Affiliation': 'Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Coutant', 'Affiliation': 'Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Klein', 'Affiliation': 'Profil, Neuss, Germany.'}, {'ForeName': 'Leona', 'Initials': 'L', 'LastName': 'Plum-Moerschel', 'Affiliation': 'Profil, Mainz, Germany.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Zijlstra', 'Affiliation': 'Profil, Neuss, Germany.'}, {'ForeName': 'Helle', 'Initials': 'H', 'LastName': 'Linnebjerg', 'Affiliation': 'Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA.'}]",Clinical therapeutics,['10.1016/j.clinthera.2020.07.005']
2683,32898095,Comparison of clinical outcomes of 3 trifocal IOLs.,"PURPOSE


To compare the clinical outcomes obtained after implantation of 1 of 3 models of diffractive trifocal IOLs.
SETTING


Hospital da Luz, Lisbon, Portugal.
DESIGN


Prospective randomized comparative study.
METHODS


Patients undergoing cataract surgery with bilateral implantation of 1 of 3 models of diffractive trifocal IOLs were enrolled. The IOL models implanted were the FineVision POD F, RayOne Trifocal, or the AcrySof IQ PanOptix IOL (30 eyes of 15 patients in each group). Visual acuity (VA), refraction, defocus curve, and contrast sensitivity outcomes were evaluated during a 3-month follow-up. Furthermore, the Quality of Vision questionnaire (QoV) was used to evaluate the frequency, severity, and discomfort of different visual symptoms.
RESULTS


A total of 90 eyes of 45 patients were included. No statistically significant differences were found between groups in distance, intermediate, and near VA (P ≥ .112) and postoperative refraction (P ≥ .059). Postoperative binocular uncorrected intermediate VA of 0.10 logarithm of the minimum angle of resolution (logMAR) or better was found in 14 (93.33%) patients in the 3 groups. Postoperative binocular uncorrected near VA of 0.10 logMAR or better was found in 13 (86.67%), 14 (93.33%), and 13 (86.67%) patients in the POD F, RayOne, and PanOptix IOLs groups, respectively. No statistically significant differences were found between groups in scotopic contrast sensitivity with and without glare and in the QoV scores (P ≥ .057), except for the difference between the POD F and RayOne IOLs groups in depth perception severity, which was less in the RayOne IOL group (P = .019).
CONCLUSIONS


The 3 trifocal IOLs evaluated provided a complete visual restoration with good visual quality outcomes.",2020,"No statistically significant differences were found between groups in scotopic contrast sensitivity with and without glare and in the QoV scores (P ≥ .057), except for the difference between the POD F and RayOne IOLs groups in depth perception severity, which was less in the RayOne IOL group (P = .019).
","['Patients undergoing cataract surgery with bilateral implantation of 1 of 3 models of diffractive trifocal IOLs were enrolled', 'A total of 90 eyes of 45 patients were included', 'Hospital da Luz, Lisbon, Portugal']",[],"['distance, intermediate, and near VA', 'frequency, severity, and discomfort of different visual symptoms', 'QoV scores', 'Visual acuity (VA), refraction, defocus curve, and contrast sensitivity outcomes', 'postoperative refraction', 'Quality of Vision questionnaire (QoV', 'scotopic contrast sensitivity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C1275646', 'cui_str': 'Trifocal glasses'}, {'cui': 'C0281658', 'cui_str': 'Intraocular Lymphoma'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0032729', 'cui_str': 'Portugal'}]",[],"[{'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0429541', 'cui_str': 'Near visual acuity'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0422943', 'cui_str': 'Visual symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0429585', 'cui_str': 'Refraction measurement - finding'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0009928', 'cui_str': 'Contrast sensitivity'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",45.0,0.0334335,"No statistically significant differences were found between groups in scotopic contrast sensitivity with and without glare and in the QoV scores (P ≥ .057), except for the difference between the POD F and RayOne IOLs groups in depth perception severity, which was less in the RayOne IOL group (P = .019).
","[{'ForeName': 'Filomena', 'Initials': 'F', 'LastName': 'Ribeiro', 'Affiliation': 'From the Hospital da Luz Lisboa (Ribeiro, Ferreira), Lisbon, Faculdade de Medicina da Universidade de Lisboa (Ribeiro), Lisbon, Visual Sciences Research Centre, University of Lisbon (Ribeiro), Lisbon, Portugal.'}, {'ForeName': 'Tiago B', 'Initials': 'TB', 'LastName': 'Ferreira', 'Affiliation': ''}]",Journal of cataract and refractive surgery,['10.1097/j.jcrs.0000000000000212']
2684,32898170,Intramuscular stimulation vs sham needling for the treatment of chronic midportion Achilles tendinopathy: A randomized controlled clinical trial.,"BACKGROUND


The insertion of filiform needles intramuscularly (a.k.a. intramuscular stimulation/dry needling) has been suggested as a possible treatment for various painful musculoskeletal conditions. Our aim was to answer the question, is intramuscular stimulation more effective than sham intramuscular stimulation/dry needling for the treatment of Achilles tendinopathy?
METHODS


52 participants with persistent midportion Achilles tendinopathy began and 46 completed one of three treatment protocols which were randomly assigned: (G3) a 12-week rehabilitation program of progressive tendon loading plus intramuscular stimulation (n = 25), (G2) the same rehabilitation program but with sham intramuscular stimulation (n = 19), or (G1) a reference group of rehabilitation program alone (as an additional control) (n = 8). The a priori primary outcome measure was change in VISA-A score at 12 weeks-VISA-A was also measured at 6 weeks, and at 6 and 12 months. Secondary outcome measures include the proportion of patients who rated themselves as much or very much improved (%), dorsiflexion range of motion (degrees), and tendon thickness (mm).
RESULTS


The study retention was 94% at 12 weeks and 88% at 1 year. VISA-A score improved in all three groups over time (p<0.0001), with no significant difference among the three groups in VISA-A score at the start of the study (mean ± SD: G3 59 ± 13, G2 57 ± 17, G1 56 ± 22), at 12 weeks (G3 76 ± 14, G2 76 ± 15, G1 82 ± 11) or at any other timepoint. The percentage of patients who rated themselves as much or very much improved (i.e. treatment success) was not different after 12 weeks (G3 70%, G2 89%, G1 86% p = 0.94), or at 26 (p = 0.62) or 52 weeks (p = 0.71). No clinically significant effects of intervention group were observed in any of the secondary outcome measures.
CONCLUSION


The addition of intramuscular stimulation to standard rehabilitation for Achilles tendinopathy did not result in any improvement over the expected clinical benefit achieved with exercise-based rehabilitation alone.",2020,"VISA-A score improved in all three groups over time (p<0.0001), with no significant difference among the three groups in VISA-A score at the start of the study (mean ± SD: G3 59 ± 13, G2 57 ± 17, G1 56 ± 22), at 12 weeks (G3 76 ± 14, G2 76 ± 15, G1 82 ± 11) or at any other timepoint.","['chronic midportion Achilles tendinopathy', '52 participants with persistent midportion', 'Achilles tendinopathy began and 46 completed one of three treatment protocols which were randomly assigned: (G3) a 12-week']","['rehabilitation program of progressive tendon loading plus intramuscular stimulation (n = 25), (G2) the same rehabilitation program but with sham intramuscular stimulation (n = 19), or (G1) a reference group of rehabilitation program alone (as an additional control', 'sham intramuscular stimulation/dry needling', 'Intramuscular stimulation vs sham needling']","['proportion of patients who rated themselves as much or very much improved (%), dorsiflexion range of motion (degrees), and tendon thickness (mm', 'change in VISA-A score', 'VISA-A score']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0001074', 'cui_str': 'Structure of Achilles tendon'}, {'cui': 'C0151936', 'cui_str': 'Disorder of tendon'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0039508', 'cui_str': 'Tendon structure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0394648', 'cui_str': 'Dry needle acupuncture'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0442824', 'cui_str': 'Very'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1318881', 'cui_str': 'Infection due to vancomycin intermediate Staphylococcus aureus'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",52.0,0.107393,"VISA-A score improved in all three groups over time (p<0.0001), with no significant difference among the three groups in VISA-A score at the start of the study (mean ± SD: G3 59 ± 13, G2 57 ± 17, G1 56 ± 22), at 12 weeks (G3 76 ± 14, G2 76 ± 15, G1 82 ± 11) or at any other timepoint.","[{'ForeName': 'Lyndal', 'Initials': 'L', 'LastName': 'Solomons', 'Affiliation': 'Department of Physical Therapy, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Jenny J Y', 'Initials': 'JJY', 'LastName': 'Lee', 'Affiliation': 'Centre for Hip Health and Mobility, Vancouver Coastal Health Research Institute, Vancouver, Canada.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Bruce', 'Affiliation': 'Kinetic Rehabilitation Centre, North Vancouver, Canada.'}, {'ForeName': 'Lynita D', 'Initials': 'LD', 'LastName': 'White', 'Affiliation': 'Department of Physical Therapy, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Scott', 'Affiliation': 'Department of Physical Therapy, University of British Columbia, Vancouver, Canada.'}]",PloS one,['10.1371/journal.pone.0238579']
2685,32898176,Participant experiences of a low-energy total diet replacement programme: A descriptive qualitative study.,"INTRODUCTION


The participants' experience of low-energy total diet replacement (TDR) programmes delivered by lay counsellors in the community for the routine treatment of obesity is currently unclear. We interviewed a sample of twelve participants who took part in the Doctor Referral of Overweight People to Low-Energy total diet replacement Treatment (DROPLET) trial and were randomised to the TDR programme.
METHODS


We purposively sampled twelve patients who took part in the DROPLET trial, and conducted in-depth telephone interviews, which were audio-recorded and transcribed verbatim. Interview questions focused on participants' experiences and perceptions of the TDR programme. We conducted a thematic analysis, actively developing themes from the data, and used the one sheet of paper (OSOP) technique to develop higher-level concepts.
RESULTS


Nine key themes were identified; Reasons for taking part, Expectations, Support and guidance from the counsellor, Time to build a personal relationship, Following the TDR Programme, Adverse events, Outcomes from the TDR, Weight Loss Maintenance, Recommending TDR to others. The relationship between participants and the counsellor was central to many of the themes. Close relationships with counsellors facilitated TDR adherence through providing one-to-one support (including during difficult times), sharing expert knowledge, and building a close relationship. Adherence was also supported by the rapid weight loss that patients reported experiencing. Overall participants reported positive experiences of the TDR, and emphasised the positive impact on their wellbeing.
DISCUSSION


Patients reported that a TDR programme delivered by lay counsellors in the community was a positive experience and effective in helping them to lose weight. Future trials should consider the central role of the person providing support and advice as a key component in the programme.",2020,"Close relationships with counsellors facilitated TDR adherence through providing one-to-one support (including during difficult times), sharing expert knowledge, and building a close relationship.",['twelve participants who took part in the Doctor Referral of Overweight People to Low-Energy total diet replacement Treatment (DROPLET) trial and were randomised to the TDR programme'],"['low-energy total diet replacement (TDR) programmes', 'low-energy total diet replacement programme']",['rapid weight loss'],"[{'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0420382', 'cui_str': 'Referral to doctor'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}]","[{'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]",12.0,0.0292774,"Close relationships with counsellors facilitated TDR adherence through providing one-to-one support (including during difficult times), sharing expert knowledge, and building a close relationship.","[{'ForeName': 'Nerys M', 'Initials': 'NM', 'LastName': 'Astbury', 'Affiliation': 'Nuffield Department of Primary Care Health Science, University of Oxford, Radcliffe Primary Care, Oxford, United Kingdom.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Albury', 'Affiliation': 'Nuffield Department of Primary Care Health Science, University of Oxford, Radcliffe Primary Care, Oxford, United Kingdom.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Nourse', 'Affiliation': 'Nuffield Department of Primary Care Health Science, University of Oxford, Radcliffe Primary Care, Oxford, United Kingdom.'}, {'ForeName': 'Susan A', 'Initials': 'SA', 'LastName': 'Jebb', 'Affiliation': 'Nuffield Department of Primary Care Health Science, University of Oxford, Radcliffe Primary Care, Oxford, United Kingdom.'}]",PloS one,['10.1371/journal.pone.0238645']
2686,32914928,Interim analysis of an open-label randomized controlled trial evaluating nasal irrigations in non-hospitalized patients with coronavirus disease 2019.,,2020,,['Non-hospitalized Patients with COVID-19'],[],[],"[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]",[],[],,0.0720634,,"[{'ForeName': 'Kyle S', 'Initials': 'KS', 'LastName': 'Kimura', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Freeman', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Bronson C', 'Initials': 'BC', 'LastName': 'Wessinger', 'Affiliation': 'Vanderbilt University School of Medicine, Nashville, TN.'}, {'ForeName': 'Veerain', 'Initials': 'V', 'LastName': 'Gupta', 'Affiliation': 'Vanderbilt University School of Medicine, Nashville, TN.'}, {'ForeName': 'Quanhu', 'Initials': 'Q', 'LastName': 'Sheng', 'Affiliation': 'Department of Biostatistics, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Li Ching', 'Initials': 'LC', 'LastName': 'Huang', 'Affiliation': 'Department of Biostatistics, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Von Wahlde', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Suman R', 'Initials': 'SR', 'LastName': 'Das', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Naweed I', 'Initials': 'NI', 'LastName': 'Chowdhury', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Justin H', 'Initials': 'JH', 'LastName': 'Turner', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Vanderbilt University Medical Center, Nashville, TN.'}]",International forum of allergy & rhinology,['10.1002/alr.22703']
2687,32906825,Velocity Loss Thresholds Reliably Control Kinetic and Kinematic Outputs during Free Weight Resistance Training.,"Exercise velocity and relative velocity loss thresholds (VLTs) are commonly used in velocity-based resistance training. This study aims to quantify the between-day reliability of 10%, 20%, and 30% VLTs on kinetic and kinematic outputs, changes in external load, and repetition characteristics in well-trained athletes. Using a repeated, counter-balanced crossover design, twelve semi-professional athletes completed five sets of the back squat with an external load corresponding to a mean concentric velocity of ~0.70 m·s -1  and a VLT applied. The testing sessions were repeated after four weeks of unstructured training to assess the long-term reliability of each VLT. A coefficient of variation (CV) <10% was used to classify outputs as reliable. Kinetic and kinematic outputs and external load were largely reliable, with only peak power during sets 2-5 within the 10% VLT condition demonstrating a CV >10% (CV: 11.14-14.92%). Alternatively, the repetitions completed within each set showed large variation (CV: 18.92-67.49%). These findings demonstrate that by utilizing VLTs, kinetic and kinematic outputs can be prescribed and replicated across training mesocycles. Thus, for practitioners wishing to reliably control the kinetic and kinematic stimulus that is being applied to their athletes, it is advised that a velocity-based approach is used.",2020,"Alternatively, the repetitions completed within each set showed large variation (CV: 18.92-67.49%).",['well-trained athletes'],[],"['Kinetic and kinematic outputs and external load', 'kinetic and kinematic outputs, changes in external load, and repetition characteristics', 'Exercise velocity and relative velocity loss thresholds (VLTs']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]",[],"[{'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}]",,0.0261417,"Alternatively, the repetitions completed within each set showed large variation (CV: 18.92-67.49%).","[{'ForeName': 'Madison', 'Initials': 'M', 'LastName': 'Pearson', 'Affiliation': 'School of Behavioural and Health Sciences, Australian Catholic University, Brisbane 4014, Queensland, Australia.'}, {'ForeName': 'Amador', 'Initials': 'A', 'LastName': 'García-Ramos', 'Affiliation': 'Department of Sports Sciences and Physical Conditioning, Faculty of Education, Universidad Católica de la Santísima Concepción, Concepción 2850, Chile.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Morrison', 'Affiliation': 'School of Behavioural and Health Sciences, Australian Catholic University, Brisbane 4014, Queensland, Australia.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Ramirez-Lopez', 'Affiliation': 'Institute for Sport, Physical Activity and Leisure, Leeds Beckett University, Leeds LS6 3GZ, West Yorkshire, UK.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Dalton-Barron', 'Affiliation': 'Institute for Sport, Physical Activity and Leisure, Leeds Beckett University, Leeds LS6 3GZ, West Yorkshire, UK.'}, {'ForeName': 'Jonathon', 'Initials': 'J', 'LastName': 'Weakley', 'Affiliation': 'School of Behavioural and Health Sciences, Australian Catholic University, Brisbane 4014, Queensland, Australia.'}]",International journal of environmental research and public health,['10.3390/ijerph17186509']
2688,32907366,Antithrombotic Effects of Combined PAR (Protease-Activated Receptor)-4 Antagonism and Factor Xa Inhibition.,"OBJECTIVE


PAR (protease-activated receptor)-4 antagonism has antiplatelet effects under conditions of high shear stress. We aimed to establish whether PAR4 antagonism had additive antithrombotic activity in the presence of factor Xa inhibition in an ex vivo model of acute arterial injury. Approach and Results: Fifteen healthy volunteers (29±6 years, 7 women) completed a phase zero double-blind randomized controlled crossover trial. Ex vivo platelet activation, platelet aggregation, and thrombus formation were measured following blood perfusion of low shear and high shear stress chambers. Upstream of the chambers, extracorporeal blood was admixed with (1) vehicle, (2) low-dose apixaban (20 ng/mL), (3) high-dose apixaban (80 ng/mL), (4) BMS-986141 (400 ng/mL), (5) BMS-968141 and low-dose apixaban, or (6) BMS-968141 and high-dose apixaban in 6 sequential studies performed in random order. Compared with vehicle, BMS-986141 demonstrated selective inhibition of PAR4-AP (agonist peptide)-stimulated platelet aggregation, platelet-monocyte aggregates, and P-selectin expression ( P ≤0.01 for all). Total thrombus area was reduced under both low shear and high shear stress conditions for all drug infusions ( P <0.0001 for all versus vehicle). BMS-968141 reduced total (≤44.4%) and platelet-rich (≤39.3%) thrombus area, whereas apixaban reduced total (≤42.9%) and fibrin-rich (≤31.6%) thrombus area. Combination of BMS-986141 with apixaban caused a further modest reduction in total thrombus area (9.6%-12.4%), especially under conditions of high shear stress ( P ≤0.027).
CONCLUSIONS


In the presence of factor Xa inhibition, PAR4 antagonism with BMS-986141 further reduces thrombus formation, especially under conditions of high shear stress. This suggests the potential for additive efficacy of combination PAR4 antagonism and factor Xa inhibition in the prevention of atherothrombotic events.",2020,Total thrombus area was reduced under both low shear and high shear stress conditions for all drug infusions ( P <0.0001 for all versus vehicle).,"['Fifteen healthy volunteers (29±6 years, 7 women']","['Combined PAR (Protease-Activated Receptor)-4 Antagonism and Factor Xa Inhibition', 'PAR4 antagonism', 'combination PAR4 antagonism and factor', 'BMS-968141 and low-dose apixaban, or (6) BMS-968141 and high-dose apixaban', 'BMS-986141 with apixaban']","['Ex vivo platelet activation, platelet aggregation, and thrombus formation', 'fibrin-rich', 'platelet-rich', 'selective inhibition of PAR4-AP (agonist peptide)-stimulated platelet aggregation, platelet-monocyte aggregates, and P-selectin expression', 'total thrombus area', 'Total thrombus area']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0032405', 'cui_str': 'Poly ADP Ribose Polymerase'}, {'cui': 'C1257901', 'cui_str': 'Proteinase-Activated Receptors'}, {'cui': 'C0015520', 'cui_str': 'Coagulation factor Xa'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C1831808', 'cui_str': 'apixaban'}, {'cui': 'C0444956', 'cui_str': 'High dose'}]","[{'cui': 'C0032173', 'cui_str': 'Platelet activation'}, {'cui': 'C0032176', 'cui_str': 'Platelet aggregation'}, {'cui': 'C0087086', 'cui_str': 'Thrombus'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0015982', 'cui_str': 'Fibrin'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}, {'cui': 'C0026473', 'cui_str': 'Monocyte'}, {'cui': 'C0205418', 'cui_str': 'Aggregate'}, {'cui': 'C0134835', 'cui_str': 'Lymphocyte antigen CD62'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]",15.0,0.16133,Total thrombus area was reduced under both low shear and high shear stress conditions for all drug infusions ( P <0.0001 for all versus vehicle).,"[{'ForeName': 'Mohammed N', 'Initials': 'MN', 'LastName': 'Meah', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, United Kingdom (M.N.M., J.R., S.J.W., D.E.N.).'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Raftis', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, United Kingdom (M.N.M., J.R., S.J.W., D.E.N.).'}, {'ForeName': 'Simon J', 'Initials': 'SJ', 'LastName': 'Wilson', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, United Kingdom (M.N.M., J.R., S.J.W., D.E.N.).'}, {'ForeName': 'Vidya', 'Initials': 'V', 'LastName': 'Perera', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, United Kingdom (M.N.M., J.R., S.J.W., D.E.N.).'}, {'ForeName': 'Samira M', 'Initials': 'SM', 'LastName': 'Garonzik', 'Affiliation': 'Bristol-Myers Squibb, Princeton Pike Facility, NJ (V.P., S.M.G., B.M., R.A.).'}, {'ForeName': 'Bindu', 'Initials': 'B', 'LastName': 'Murthy', 'Affiliation': 'Bristol-Myers Squibb, Princeton Pike Facility, NJ (V.P., S.M.G., B.M., R.A.).'}, {'ForeName': 'J Gerry', 'Initials': 'JG', 'LastName': 'Everlof', 'Affiliation': 'Brisol-Myers Squibb, Lawrenceville Facility, Princeton, NJ (J.G.E., J.L.).'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Aronson', 'Affiliation': 'Bristol-Myers Squibb, Princeton Pike Facility, NJ (V.P., S.M.G., B.M., R.A.).'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Luettgen', 'Affiliation': 'Brisol-Myers Squibb, Lawrenceville Facility, Princeton, NJ (J.G.E., J.L.).'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Newby', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, United Kingdom (M.N.M., J.R., S.J.W., D.E.N.).'}]","Arteriosclerosis, thrombosis, and vascular biology",['10.1161/ATVBAHA.120.314960']
2689,32907828,"Dual-Hormone Closed-Loop System Using a Liquid Stable Glucagon Formulation Versus Insulin-Only Closed-Loop System Compared With a Predictive Low Glucose Suspend System: An Open-Label, Outpatient, Single-Center, Crossover, Randomized Controlled Trial.","OBJECTIVE


To assess the efficacy and feasibility of a dual-hormone (DH) closed-loop system with insulin and a novel liquid stable glucagon formulation compared with an insulin-only closed-loop system and a predictive low glucose suspend (PLGS) system.
RESEARCH DESIGN AND METHODS


In a 76-h, randomized, crossover, outpatient study, 23 participants with type 1 diabetes used three modes of the Oregon Artificial Pancreas system:  1 ) dual-hormone (DH) closed-loop control,  2 ) insulin-only single-hormone (SH) closed-loop control, and  3 ) PLGS system. The primary end point was percentage time in hypoglycemia (<70 mg/dL) from the start of in-clinic aerobic exercise (45 min at 60% VO 2max ) to 4 h after.
RESULTS


DH reduced hypoglycemia compared with SH during and after exercise (DH 0.0% [interquartile range 0.0-4.2], SH 8.3% [0.0-12.5],  P  = 0.025). There was an increased time in hyperglycemia (>180 mg/dL) during and after exercise for DH versus SH (20.8% DH vs. 6.3% SH,  P  = 0.038). Mean glucose during the entire study duration was DH, 159.2; SH, 151.6; and PLGS, 163.6 mg/dL. Across the entire study duration, DH resulted in 7.5% more time in target range (70-180 mg/dL) compared with the PLGS system (71.0% vs. 63.4%,  P  = 0.044). For the entire study duration, DH had 28.2% time in hyperglycemia vs. 25.1% for SH ( P  = 0.044) and 34.7% for PLGS ( P  = 0.140). Four participants experienced nausea related to glucagon, leading three to withdraw from the study.
CONCLUSIONS


The glucagon formulation demonstrated feasibility in a closed-loop system. The DH system reduced hypoglycemia during and after exercise, with some increase in hyperglycemia.",2020,"RESULTS


DH reduced hypoglycemia compared with SH during and after exercise (DH 0.0% [interquartile range 0.0-4.2], SH 8.3% [0.0-12.5],  P  = 0.025).",['23 participants with type 1 diabetes used three modes of the Oregon Artificial Pancreas system:  1 '],"['Dual-Hormone Closed-Loop System Using a Liquid Stable Glucagon Formulation Versus Insulin-Only Closed-Loop System Compared With a Predictive Low Glucose Suspend System', 'dual-hormone (DH) closed-loop control,  2 ) insulin-only single-hormone (SH) closed-loop control, and  3 ) PLGS system', 'glucagon', 'dual-hormone (DH) closed-loop system with insulin and a novel liquid stable glucagon formulation']","['Mean glucose', 'hyperglycemia', 'hypoglycemia', 'time in hyperglycemia', 'nausea', 'percentage time in hypoglycemia']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0029195', 'cui_str': 'Oregon'}, {'cui': 'C0336563', 'cui_str': 'Artificial pancreas'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0445022', 'cui_str': 'Loop'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0017687', 'cui_str': 'Glucagon'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0860801', 'cui_str': 'Glucose low'}, {'cui': 'C0038959', 'cui_str': 'Suspending Agents'}, {'cui': 'C0443183', 'cui_str': 'Closed loop'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205314', 'cui_str': 'New'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0439165', 'cui_str': 'Percent'}]",23.0,0.0307921,"RESULTS


DH reduced hypoglycemia compared with SH during and after exercise (DH 0.0% [interquartile range 0.0-4.2], SH 8.3% [0.0-12.5],  P  = 0.025).","[{'ForeName': 'Leah M', 'Initials': 'LM', 'LastName': 'Wilson', 'Affiliation': 'Harold Schnitzer Diabetes Health Center, Division of Endocrinology, Oregon Health & Science University, Portland, OR wilsolea@ohsu.edu.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Jacobs', 'Affiliation': 'Artificial Intelligence for Medical Systems (AIMS) Lab, Department of Biomedical Engineering, Oregon Health & Science University, Portland, OR.'}, {'ForeName': 'Katrina L', 'Initials': 'KL', 'LastName': 'Ramsey', 'Affiliation': 'Oregon Clinical and Translational Research Institute Biostatistics and Design Program, Oregon Health & Science University & Portland State University School of Public Health, Portland, OR.'}, {'ForeName': 'Navid', 'Initials': 'N', 'LastName': 'Resalat', 'Affiliation': 'Artificial Intelligence for Medical Systems (AIMS) Lab, Department of Biomedical Engineering, Oregon Health & Science University, Portland, OR.'}, {'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Reddy', 'Affiliation': 'Artificial Intelligence for Medical Systems (AIMS) Lab, Department of Biomedical Engineering, Oregon Health & Science University, Portland, OR.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Branigan', 'Affiliation': 'Harold Schnitzer Diabetes Health Center, Division of Endocrinology, Oregon Health & Science University, Portland, OR.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Leitschuh', 'Affiliation': 'Artificial Intelligence for Medical Systems (AIMS) Lab, Department of Biomedical Engineering, Oregon Health & Science University, Portland, OR.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Gabo', 'Affiliation': 'Harold Schnitzer Diabetes Health Center, Division of Endocrinology, Oregon Health & Science University, Portland, OR.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Guillot', 'Affiliation': 'Harold Schnitzer Diabetes Health Center, Division of Endocrinology, Oregon Health & Science University, Portland, OR.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Senf', 'Affiliation': 'Harold Schnitzer Diabetes Health Center, Division of Endocrinology, Oregon Health & Science University, Portland, OR.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'El Youssef', 'Affiliation': 'Harold Schnitzer Diabetes Health Center, Division of Endocrinology, Oregon Health & Science University, Portland, OR.'}, {'ForeName': 'Isabelle Isa Kristin', 'Initials': 'IIK', 'LastName': 'Steineck', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Nichole S', 'Initials': 'NS', 'LastName': 'Tyler', 'Affiliation': 'Artificial Intelligence for Medical Systems (AIMS) Lab, Department of Biomedical Engineering, Oregon Health & Science University, Portland, OR.'}, {'ForeName': 'Jessica R', 'Initials': 'JR', 'LastName': 'Castle', 'Affiliation': 'Harold Schnitzer Diabetes Health Center, Division of Endocrinology, Oregon Health & Science University, Portland, OR.'}]",Diabetes care,['10.2337/dc19-2267']
2690,32910476,Higher serum PD-L1 level predicts increased overall survival with lapatinib versus trastuzumab in the CCTG MA.31 phase 3 trial.,"BACKGROUND


The purpose of this retrospective biomarker study of the Canadian Cancer Trials Group (CCTG) MA.31 randomized phase 3 trial (lapatinib vs trastuzumab) of HER2-positive metastatic breast cancer (MBC) was to evaluate the prognostic and predictive biomarker utility of pretreatment serum programmed death ligand 1 (PD-L1) levels.
METHODS


CCTG MA.31 accrued 652 HER2-positive patients; 387 had serum available (185 in the trastuzumab arm and 202 in the lapatinib arm). The Ella immunoassay platform (ProteinSimple, San Jose, California) was used to quantitate serum PD-L1 levels. Stepwise forward Cox multivariable analyses were performed for progression-free survival and overall survival (OS).
RESULTS


In the whole trial population, continuous pretreatment serum PD-L1 levels were not associated with OS. However, within the trastuzumab arm, a higher continuous pretreatment serum PD-L1 level was significant for shorter OS (hazard ratio [HR], 3.85; P = .04), but within the lapatinib arm, pretreatment serum PD-L1 was not associated with OS (P = .37). In the whole trial, in a multivariable analysis for OS, serum PD-L1 (median cut point) remained a significant independent covariate (HR, 2.38; P = .001). There was a significant interaction between treatment arm and continuous serum PD-L1 (bootstrap method; P = .0025): at or above 214.2 pg/mL (the 89th percentile), serum PD-L1 was associated with significantly shorter OS with trastuzumab treatment versus lapatinib treatment.
CONCLUSIONS


In the CCTG MA.31 trial, serum PD-L1 was a significant predictive factor: a higher pretreatment serum PD-L1 level was associated with shorter OS with trastuzumab treatment but with longer OS with lapatinib treatment. Immune evasion may decrease the effectiveness of trastuzumab therapy. Further evaluation of elevated serum PD-L1 in advanced breast cancer is warranted to identify patients with HER2-positive MBC who may benefit from novel immune-targeted therapies in addition to trastuzumab.",2020,"However, within the trastuzumab arm, a higher continuous pretreatment serum PD-L1 level was significant for shorter OS (hazard ratio [HR], 3.85; P = .04), but within the lapatinib arm, pretreatment serum PD-L1 was not associated with OS (P = .37).","['CCTG MA.31 accrued 652 HER2-positive patients; 387 had serum available (185 in the trastuzumab arm and 202 in the lapatinib arm', 'HER2-positive metastatic breast cancer (MBC', 'patients with HER2-positive MBC']","['lapatinib versus trastuzumab', 'lapatinib vs trastuzumab']","['serum PD-L1', 'progression-free survival and overall survival (OS', 'serum PD-L1 levels', 'serum PD-L1 level', 'overall survival']","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C4517617', 'cui_str': '185'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C1506770', 'cui_str': 'lapatinib'}, {'cui': 'C4721209', 'cui_str': 'Metastatic human epidermal growth factor 2 positive carcinoma of breast'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}]","[{'cui': 'C1506770', 'cui_str': 'lapatinib'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",652.0,0.0795987,"However, within the trastuzumab arm, a higher continuous pretreatment serum PD-L1 level was significant for shorter OS (hazard ratio [HR], 3.85; P = .04), but within the lapatinib arm, pretreatment serum PD-L1 was not associated with OS (P = .37).","[{'ForeName': 'Prashanth', 'Initials': 'P', 'LastName': 'Moku', 'Affiliation': 'Penn State Hershey Medical Center, Hershey, Pennsylvania.'}, {'ForeName': 'Lois', 'Initials': 'L', 'LastName': 'Shepherd', 'Affiliation': ""Canadian Cancer Trials Group, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'Suhail M', 'Initials': 'SM', 'LastName': 'Ali', 'Affiliation': 'Penn State Hershey Medical Center, Hershey, Pennsylvania.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Leitzel', 'Affiliation': 'Penn State Hershey Medical Center, Hershey, Pennsylvania.'}, {'ForeName': 'Wendy R', 'Initials': 'WR', 'LastName': 'Parulekar', 'Affiliation': ""Canadian Cancer Trials Group, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'Liting', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': ""Canadian Cancer Trials Group, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'Shakeel', 'Initials': 'S', 'LastName': 'Virk', 'Affiliation': ""Canadian Cancer Trials Group, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'Dora', 'Initials': 'D', 'LastName': 'Nomikos', 'Affiliation': ""Canadian Cancer Trials Group, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Aparicio', 'Affiliation': 'British Columbia Cancer Agency, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Gelmon', 'Affiliation': 'British Columbia Cancer Agency, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Joe', 'Initials': 'J', 'LastName': 'Drabick', 'Affiliation': 'Penn State Hershey Medical Center, Hershey, Pennsylvania.'}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Cream', 'Affiliation': 'Penn State Hershey Medical Center, Hershey, Pennsylvania.'}, {'ForeName': 'E Scott', 'Initials': 'ES', 'LastName': 'Halstead', 'Affiliation': 'Penn State Hershey Medical Center, Hershey, Pennsylvania.'}, {'ForeName': 'Todd M', 'Initials': 'TM', 'LastName': 'Umstead', 'Affiliation': 'Penn State Hershey Medical Center, Hershey, Pennsylvania.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Mckeone', 'Affiliation': 'Penn State Hershey Medical Center, Hershey, Pennsylvania.'}, {'ForeName': 'Hyma', 'Initials': 'H', 'LastName': 'Polimera', 'Affiliation': 'Penn State Hershey Medical Center, Hershey, Pennsylvania.'}, {'ForeName': 'Ashok', 'Initials': 'A', 'LastName': 'Maddukuri', 'Affiliation': 'Penn State Hershey Medical Center, Hershey, Pennsylvania.'}, {'ForeName': 'Aamnah', 'Initials': 'A', 'LastName': 'Ali', 'Affiliation': 'Penn State Hershey Medical Center, Hershey, Pennsylvania.'}, {'ForeName': 'Vinod', 'Initials': 'V', 'LastName': 'Nagabhairu', 'Affiliation': 'Pinnacle Health, Harrisburg, Pennsylvania.'}, {'ForeName': 'Joyson', 'Initials': 'J', 'LastName': 'Poulose', 'Affiliation': 'Penn State Hershey Medical Center, Hershey, Pennsylvania.'}, {'ForeName': 'Neha', 'Initials': 'N', 'LastName': 'Pancholy', 'Affiliation': 'Penn State Hershey Medical Center, Hershey, Pennsylvania.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Spiegel', 'Affiliation': 'ProteinSimple, San Jose, California.'}, {'ForeName': 'Bingshu E', 'Initials': 'BE', 'LastName': 'Chen', 'Affiliation': ""Canadian Cancer Trials Group, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Lipton', 'Affiliation': 'Penn State Hershey Medical Center, Hershey, Pennsylvania.'}]",Cancer,['10.1002/cncr.33149']
2691,32910478,Results of an early safety analysis of a study of the combination of pembrolizumab and pelvic chemoradiation in locally advanced cervical cancer.,"BACKGROUND


Immune checkpoint inhibitors are being considered for locally advanced cervical cancer (LACC) together with standard-of-care pelvic chemoradiation (CRT). However, the safety of the combination and its optimal schedule are unknown. Defining the safety of the combination is a primary objective of a study examining concurrent and sequential schedules. This article presents a safety analysis that was fully accrued and met reporting requirements.
METHODS


Pembrolizumab was given after CRT (arm 1) or during CRT (arm 2) according to a randomized phase 2 design. Patients who were 18 years old or older and had LACC (stages IB-IVA according to the 2009 International Federation of Gynecology and Obstetrics system) were randomized 1:1 to the treatment regimens. The CRT was identical in the 2 arms. Pembrolizumab was administered every 3 weeks for 3 doses; no maintenance was allowed. All patients receiving any treatment were evaluated for safety. Safety assessments included the incidence and severity of adverse events (AEs) and the occurrence of protocol-defined dose-limiting toxicity (DLT) through 30 days after the last pembrolizumab infusion.
RESULTS


As of August 2019, 52 of the 88 planned patients had completed treatment and were evaluable for toxicity. Treatment-related grade 2 or higher toxicity was experienced by 88%; 11 had at least 1 grade 4 AE, and another 23 had at least 1 grade 3 AE. Grade 1 or higher diarrhea was reported in 34 patients (65%; 50% of these were grade 1), and there was no difference between arms (63% in arm 1 vs 68% in arm 2). Two patients experienced 3 DLTs. Most patients completed cisplatin (100% in arm 1 vs 82% in arm 2); 83% in both arms completed all pembrolizumab.
CONCLUSIONS


Preliminary results support the safety and feasibility of adding pembrolizumab to pelvic CRT concurrently or sequentially.
LAY SUMMARY


Pembrolizumab is a humanized antibody against programmed cell death protein 1 that is used in cancer immunotherapy. Preliminary data suggest that pembrolizumab can be safely combined with chemotherapy and pelvic radiation in the treatment of locally advanced cervical cancer. Future studies of the addition of immunotherapy to traditional chemoradiation are planned to determine the best way to deliver the treatment and whether any improvement is seen with the addition of immunotherapy to traditional therapy.",2020,"Most patients completed cisplatin (100% in arm 1 vs 82% in arm 2); 83% in both arms completed all pembrolizumab.
","['locally advanced cervical cancer', 'Patients who were 18 years old or older and had LACC (stages IB-IVA according to the 2009 International Federation of Gynecology and Obstetrics system']","['pembrolizumab and pelvic chemoradiation', 'pembrolizumab', 'cisplatin', 'chemotherapy and pelvic radiation', 'Pembrolizumab']","['Grade 1 or higher diarrhea', 'toxicity', 'incidence and severity of adverse events (AEs) and the occurrence of protocol-defined dose-limiting toxicity (DLT']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0456597', 'cui_str': 'Stage 1B'}, {'cui': 'C0268575', 'cui_str': 'Isovaleryl-CoA dehydrogenase deficiency'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}]","[{'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439801', 'cui_str': 'Limited'}]",,0.105333,"Most patients completed cisplatin (100% in arm 1 vs 82% in arm 2); 83% in both arms completed all pembrolizumab.
","[{'ForeName': 'Linda R', 'Initials': 'LR', 'LastName': 'Duska', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Virginia School of Medicine, Charlottesville, Virginia.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Scalici', 'Affiliation': 'Mitchell Cancer Institute, USA Health, Mobile, Alabama.'}, {'ForeName': 'Sarah M', 'Initials': 'SM', 'LastName': 'Temkin', 'Affiliation': 'Anne Arundel Medical Center, Annapolis, Maryland.'}, {'ForeName': 'Julie K', 'Initials': 'JK', 'LastName': 'Schwarz', 'Affiliation': 'Department of Radiation Oncology, Washington University School of Medicine, Saint Louis, Missouri.'}, {'ForeName': 'Erin K', 'Initials': 'EK', 'LastName': 'Crane', 'Affiliation': 'Division of Gynecologic Oncology, Levine Cancer Institute, Charlotte, North Carolina.'}, {'ForeName': 'Katherine M', 'Initials': 'KM', 'LastName': 'Moxley', 'Affiliation': 'Stephenson Cancer Center, University of Oklahoma Sciences Center, Oklahoma City, Oklahoma.'}, {'ForeName': 'Chad A', 'Initials': 'CA', 'LastName': 'Hamilton', 'Affiliation': 'Inova Schar Cancer Institute, Fairfax, Virginia.'}, {'ForeName': 'Stephanie L', 'Initials': 'SL', 'LastName': 'Wethington', 'Affiliation': 'Division of Gynecologic Oncology, Department of Gynecology and Obstetrics, Johns Hopkins School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Gina R', 'Initials': 'GR', 'LastName': 'Petroni', 'Affiliation': 'Public Health Sciences, University of Virginia School of Medicine, Charlottesville, Virginia.'}, {'ForeName': 'Nikole E', 'Initials': 'NE', 'LastName': 'Varhegyi', 'Affiliation': 'Public Health Sciences, University of Virginia School of Medicine, Charlottesville, Virginia.'}, {'ForeName': 'Sheena H', 'Initials': 'SH', 'LastName': 'Clift', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Virginia School of Medicine, Charlottesville, Virginia.'}, {'ForeName': 'Timothy N J', 'Initials': 'TNJ', 'LastName': 'Bullock', 'Affiliation': 'Department of Pathology, University of Virginia School of Medicine, Charlottesville, Virginia.'}, {'ForeName': 'Timothy N', 'Initials': 'TN', 'LastName': 'Showalter', 'Affiliation': 'Department of Radiation Oncology, University of Virginia School of Medicine, Charlottesville, Virginia.'}]",Cancer,['10.1002/cncr.33136']
2692,32911350,Medication adherence and rate of nicotine metabolism are associated with response to treatment with varenicline among smokers with HIV.,"INTRODUCTION


PLWHA who smoke have shown lower cessation rates within placebo-controlled randomized trials of varenicline. Adherence and rate of nicotine metabolism may be associated with quit rates in such clinical trials.
METHODS


This secondary analysis of a randomized placebo-controlled trial of varenicline for smoking among PLWHA (N = 179) examined the relationship between varenicline adherence (pill count, ≥80% of pills), nicotine metabolism (based on the nicotine metabolite ratio; NMR) and end-of-treatment smoking cessation (self-reported 7-day point prevalence abstinence, confirmed with carbon monoxide of ≤ 8 ppm, at the end of treatment; EOT).
RESULTS


Combining varenicline and placebo arms, greater adherence (OR = 1.011, 95% CI:1.00-1.02, p = 0.051) and faster nicotine metabolism (OR = 3.08, 95% CI:1.01-9.37, p = 0.047) were related to higher quit rates. In separate models, adherence (OR = 1.009, 95% CI:1.004-1.01, p < 0.001) and nicotine metabolism rate (OR = 2.04, 95% CI:1.19-3.49, p = 0.009) interacted with treatment arm to effect quit rates. The quit rate for varenicline vs. placebo was higher for both non-adherent (19% vs. 5%; χ 2 [1] = 2.80, p = 0.09) and adherent (35% vs. 15%; χ 2 [1] = 6.51, p = 0.01) participants, but the difference between treatment arms was statistically significant only for adherent participants. Likewise, among slow metabolizers (NMR < 0.31), the varenicline quit rate was not significantly higher vs. placebo (14% vs. 5%; χ 2 [1] = 1.17, p = 0.28) but, among fast metabolizers (NMR ≥ 0.31), the quit rate for varenicline was significantly higher vs. placebo (33% vs. 14%; χ 2 [1] = 4.43, p = 0.04).
CONCLUSIONS


Increasing varenicline adherence and ensuring that fast nicotine metabolizers receive varenicline may increase quit rates for PLWHA.",2021,"Combining varenicline and placebo arms, greater adherence (OR = 1.011, 95% CI:1.00-1.02, p = 0.051) and faster nicotine metabolism (OR = 3.08, 95% CI:1.01-9.37, p = 0.047) were related to higher quit rates.",['smokers with HIV'],"['varenicline and placebo', 'varenicline', 'varenicline vs. placebo', 'varenicline adherence (pill count, ≥80% of pills), nicotine metabolism (based on the nicotine metabolite ratio; NMR) and end-of-treatment smoking cessation', 'placebo']","['nicotine metabolism rate', 'varenicline quit rate', 'quit rate for varenicline', 'quit rate', 'Medication adherence and rate of nicotine metabolism', 'faster nicotine metabolism']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}]","[{'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C1095963', 'cui_str': 'Smoking cessation therapy'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}]",179.0,0.482863,"Combining varenicline and placebo arms, greater adherence (OR = 1.011, 95% CI:1.00-1.02, p = 0.051) and faster nicotine metabolism (OR = 3.08, 95% CI:1.01-9.37, p = 0.047) were related to higher quit rates.","[{'ForeName': 'Anna-Marika', 'Initials': 'AM', 'LastName': 'Bauer', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, United States.'}, {'ForeName': 'Mackenzie', 'Initials': 'M', 'LastName': 'Hosie Quinn', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, United States.'}, {'ForeName': 'Su Fen', 'Initials': 'SF', 'LastName': 'Lubitz', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, United States.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Flitter', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, United States.'}, {'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Ashare', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, United States.'}, {'ForeName': 'Frank T', 'Initials': 'FT', 'LastName': 'Leone', 'Affiliation': 'Department of Medicine/Division of Pulmonary, Allergy, & Critical Care, University of Pennsylvania, United States.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Gross', 'Affiliation': 'Department of Medicine/Division of Infectious Diseases, University of Pennsylvania, United States; Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania, United States.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Hitsman', 'Affiliation': 'Department of Preventive Medicine, Feinberg School of Medicine, Northwestern University, United States.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Schnoll', 'Affiliation': 'Department of Psychiatry and Abramson Cancer Center, University of Pennsylvania, United States. Electronic address: schnoll@pennmedicine.upenn.edu.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106638']
2693,32906032,The MUC5B promoter variant does not predict progression of interstitial lung disease in systemic sclerosis.,"OBJECTIVE


To investigate the prevalence of the MUC5B promoter variant rs35705950 in patients with systemic sclerosis-interstitial lung disease (SSc-ILD) and whether its presence predicts response to immunosuppression with cyclophosphamide (CYC) and mycophenolate (MMF).
METHODS


SSc-ILD patients who participated in Scleroderma Lung Study (SLS) II (MMF versus CYC) were included in this study (N = 142). TaqMan Genotyping Assays were used to determine the MUC5B rs35705950 single nucleotide polymorphism. Joint models were created to examine how the presence of this variant affected the course of the forced vital capacity (FVC) over 2 years. Linear regression models were used to investigate the relationship between the presence of this variant and the change in quantitative radiographic fibrosis.
RESULTS


Among 128 participants who were tested for this variant, 18% possessed at least one copy of the MUC5B minor allele. Patients with at least one copy of this allele were similar to those without the allele with respect to age, sex, SSc subtype, ILD disease severity; however, this variant was rare among African Americans (3.7%). The presence of the MUC5B variant did not affect the course of the FVC, nor the change in quantitative radiographic fibrosis, ground glass or ILD scores in either treatment arm.
CONCLUSION


In the context of a randomized controlled trial for SSc-ILD, the presence of the MUC5B variant did not predict disease severity, nor affect treatment response to MMF or CYC. Future studies are needed to determine whether this variant affects ILD progression in other SSc cohorts and in patients receiving anti-fibrotic therapy.",2020,"Patients with at least one copy of this allele were similar to those without the allele with respect to age, sex, SSc subtype, ILD disease severity; however, this variant was rare among African Americans (3.7%).","['patients with systemic sclerosis-interstitial lung disease (SSc-ILD', '128 participants who were tested for this variant, 18% possessed at least one copy of the MUC5B minor allele', 'SSc-ILD patients who participated in Scleroderma Lung Study (SLS) II (MMF versus CYC) were included in this study (N\u202f=\u202f142']","['MUC5B promoter variant rs35705950', 'cyclophosphamide (CYC) and mycophenolate (MMF']","['quantitative radiographic fibrosis, ground glass or ILD scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036421', 'cui_str': 'Systemic sclerosis'}, {'cui': 'C0206062', 'cui_str': 'Interstitial lung disease'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205419', 'cui_str': 'Variant'}, {'cui': 'C0537987', 'cui_str': 'Mucin-5 Subtype B, Tracheobronchial'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0002085', 'cui_str': 'Genetic alleles'}, {'cui': 'C0011644', 'cui_str': 'Scleroderma'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0083765', 'cui_str': 'NMF protocol'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0537987', 'cui_str': 'Mucin-5 Subtype B, Tracheobronchial'}, {'cui': 'C0205419', 'cui_str': 'Variant'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0883242', 'cui_str': 'MYCOPHENOLATE'}, {'cui': 'C0083765', 'cui_str': 'NMF protocol'}]","[{'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}, {'cui': 'C0206062', 'cui_str': 'Interstitial lung disease'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0532196,"Patients with at least one copy of this allele were similar to those without the allele with respect to age, sex, SSc subtype, ILD disease severity; however, this variant was rare among African Americans (3.7%).","[{'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Volkmann', 'Affiliation': 'Department of Medicine, University of California, Los Angeles, David Geffen School of Medicine, USA. Electronic address: evolkmann@mednet.ucla.edu.'}, {'ForeName': 'Donald P', 'Initials': 'DP', 'LastName': 'Tashkin', 'Affiliation': 'Department of Medicine, University of California, Los Angeles, David Geffen School of Medicine, USA.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Roth', 'Affiliation': 'Department of Medicine, University of California, Los Angeles, David Geffen School of Medicine, USA.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'Department of Medicine, University of California, Los Angeles, David Geffen School of Medicine, USA.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Charles', 'Affiliation': 'McGovern Medical School at the University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Mayes', 'Affiliation': 'McGovern Medical School at the University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Kim', 'Affiliation': 'Department of Radiology, University of California, Los Angeles, David Geffen School of Medicine, Los Angeles, USA; Department of Biostatistics, University of California, Los Angeles, Fielding School of Public Health Los Angeles, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Goldin', 'Affiliation': 'Department of Radiology, University of California, Los Angeles, David Geffen School of Medicine, Los Angeles, USA.'}, {'ForeName': 'Lila', 'Initials': 'L', 'LastName': 'Pourzand', 'Affiliation': 'Department of Radiology, University of California, Los Angeles, David Geffen School of Medicine, Los Angeles, USA.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Clements', 'Affiliation': 'Department of Medicine, University of California, Los Angeles, David Geffen School of Medicine, USA.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Furst', 'Affiliation': 'Department of Medicine, University of California, Los Angeles, David Geffen School of Medicine, USA; Department of Medicine, University of Washington, Seattle, USA; Department of Rheumatology, University of Florence, Florence, Italy.'}, {'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Khanna', 'Affiliation': 'Department of Medicine, University of Michigan Medical School, Ann Arbor, USA.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Elashoff', 'Affiliation': 'Department of Biomathematics, University of California, Los Angeles, USA.'}, {'ForeName': 'Shervin', 'Initials': 'S', 'LastName': 'Assassi', 'Affiliation': 'McGovern Medical School at the University of Texas Health Science Center at Houston, Houston, TX, USA.'}]",Seminars in arthritis and rheumatism,['10.1016/j.semarthrit.2020.06.003']
2694,32921262,Risk of Paradoxical Embolism (RoPE)-Estimated Attributable Fraction Correlates With the Benefit of Patent Foramen Ovale Closure: An Analysis of 3 Trials.,"BACKGROUND AND PURPOSE


In patients with cryptogenic stroke and patent foramen ovale (PFO), the Risk of Paradoxical Embolism (RoPE) Score has been proposed as a method to estimate a patient-specific ""PFO-attributable fraction""-the probability that a documented PFO is causally-related to the stroke, rather than an incidental finding. The objective of this research is to examine the relationship between this RoPE-estimated PFO-attributable fraction and the effect of closure in 3 randomized trials.
METHODS


We pooled data from the CLOSURE-I (Evaluation of the STARFlex Septal Closure System in Patients With a Stroke and/or Transient Ischemic Attack due to Presumed Paradoxical Embolism through a Patent Foramen Ovale), RESPECT (Randomized Evaluation of Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment), and PC (Clinical Trial Comparing Percutaneous Closure of Patent Foramen Ovale [PFO] Using the Amplatzer PFO Occluder With Medical Treatment in Patients With Cryptogenic Embolism) trials. We examine the treatment effect of closure in high RoPE score (≥7) versus low RoPE score (<7) patients. We also estimated the relative risk reduction associated with PFO closure across each level of the RoPE score using Cox proportional hazard analysis. We estimated a patient-specific attributable fraction using a PC trial-compatible (9-point) RoPE equation (omitting the neuroradiology variable), as well as a 2-trial analysis using the original (10-point) RoPE equation. We examined the Pearson correlation between the estimated attributable fraction and the relative risk reduction across RoPE strata.
RESULTS


In the low RoPE score group (<7, n=912), the rate of recurrent strokes per 100 person-years was 1.37 in the device arm versus 1.68 in the medical arm (hazard ratio, 0.82 [0.42-1.59]  P =0.56) compared with 0.30 versus 1.03 (hazard ratio, 0.31 [0.11-0.85]  P =0.02) in the high RoPE score group (≥7, n=1221); treatment-by-RoPE score group interaction,  P =0.12. The RoPE score estimated attributable fraction anticipated the relative risk reduction across all levels of the RoPE score, in both the 3-trial ( r =0.95,  P <0.001) and 2-trial ( r =0.92,  P <0.001) analyses.
CONCLUSIONS


The RoPE score estimated attributable fraction is highly correlated to the relative risk reduction of device versus medical therapy. This observation suggests the RoPE score identifies patients with cryptogenic stroke who are likely to have a PFO that is pathogenic rather than incidental.",2020,"In patients with cryptogenic stroke and patent foramen ovale (PFO), the Risk of Paradoxical Embolism (RoPE) Score has been proposed as a method to estimate a patient-specific ""PFO-attributable fraction""-the probability that a documented PFO is causally-related to the stroke, rather than an incidental finding.","['Patients', 'Patients With Cryptogenic Embolism', 'patients with cryptogenic stroke and patent foramen ovale (PFO', 'patients with cryptogenic stroke', 'Foramen Ovale [PFO', 'Patent Foramen Ovale Closure']","['Amplatzer PFO Occluder With Medical Treatment', 'Percutaneous Closure of Patent']",['rate of recurrent strokes'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0013922', 'cui_str': 'Embolism'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0016522', 'cui_str': 'Patent foramen ovale'}, {'cui': 'C0016521', 'cui_str': 'Structure of foramen ovale of heart'}, {'cui': 'C0189967', 'cui_str': 'Closure of patent foramen ovale'}]","[{'cui': 'C0016522', 'cui_str': 'Patent foramen ovale'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0030650', 'cui_str': 'Patents'}]","[{'cui': 'C1836785', 'cui_str': 'Recurrent stroke'}]",,0.138451,"In patients with cryptogenic stroke and patent foramen ovale (PFO), the Risk of Paradoxical Embolism (RoPE) Score has been proposed as a method to estimate a patient-specific ""PFO-attributable fraction""-the probability that a documented PFO is causally-related to the stroke, rather than an incidental finding.","[{'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Kent', 'Affiliation': 'Predictive Analytics and Comparative Effectiveness (PACE) Center, Institute for Clinical Research and Health Policy Studies, Tufts Medical Center/Tufts University School of Medicine, Boston, MA. (D.M.K., R.R.).'}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Saver', 'Affiliation': 'Comprehensive Stroke Center and Department of Neurology, David Geffen School of Medicine/University of California Los Angeles (J.L.S.).'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Ruthazer', 'Affiliation': 'Predictive Analytics and Comparative Effectiveness (PACE) Center, Institute for Clinical Research and Health Policy Studies, Tufts Medical Center/Tufts University School of Medicine, Boston, MA. (D.M.K., R.R.).'}, {'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'Furlan', 'Affiliation': 'Department of Neurology, Case Western Reserve University, Cleveland, OH (A.J.F.).'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Reisman', 'Affiliation': 'Division of Cardiology, University of Washington Medical Center, Seattle (M.R.).'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Carroll', 'Affiliation': 'Division of Cardiology, Department of Medicine, University of Colorado Denver, Aurora (J.D.C.).'}, {'ForeName': 'Richard W', 'Initials': 'RW', 'LastName': 'Smalling', 'Affiliation': 'Division of Cardiology, Department of Medicine, University of Texas Medical School at Houston (R.W.S.).'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Jüni', 'Affiliation': ""Applied Health Research Centre (AHRC), Li Ka Shing Knowledge Institute of St. Michael's Hospital, Department of Medicine and Institute of Health Policy, Management and Evaluation, University of Toronto, ON, Canada (P.J.).""}, {'ForeName': 'Heinrich P', 'Initials': 'HP', 'LastName': 'Mattle', 'Affiliation': 'Department of Neurology, Bern University Hospital, Bern, Switzerland. (H.P.M.).'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Meier', 'Affiliation': 'Department of Cardiology, Bern University Hospital, Bern, Switzerland. (B.M.).'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Thaler', 'Affiliation': 'Department of Neurology, Tufts Medical Center/Tufts University School of Medicine, Boston, MA. (D.M.K., D.E.T.).'}]",Stroke,['10.1161/STROKEAHA.120.029350']
2695,32923686,Foot thermometry with mHeath-based supplementation to prevent diabetic foot ulcers: A randomized controlled trial.,"Background : Novel approaches to reduce diabetic foot ulcers (DFU) in low- and middle-income countries are needed. Our objective was to compare incidence of DFUs in the thermometry plus mobile health (mHealth) reminders (intervention) vs. thermometry-only (control).  Methods : We conducted a randomized trial enrolling adults with type 2 diabetes mellitus at risk of foot ulcers (risk groups 2 or 3) but without foot ulcers at the time of recruitment, and allocating them to control (instruction to use a liquid crystal-based foot thermometer daily) or intervention (same instruction supplemented with text and voice messages with reminders to use the device and messages to promote foot care) groups, and followed for 18 months. The primary outcome was time to occurrence of DFU. A process evaluation was also conducted.  Results : A total of 172 patients (63% women, mean age 61 years) were enrolled; 86 to each study group. More patients enrolled in the intervention arm had a history of previous DFU (66% vs. 48%). Follow-up for the primary endpoint was complete for 158 of 172 participants (92%). Adherence to ≥80% of daily temperature measurements was 87% (103 of 118) among the study participants who returned the logbook. DFU cumulative incidence was 24% (19 of 79) in the intervention arm and 11% (9 of 79) in the control arm. After adjusting for history of foot ulceration and study site, the hazard ratio (HR) for DFU was 1.44 (95% CI 0.65, 3.22).  Conclusions : In our study, conducted in a low-income setting, the addition of mHealth to foot thermometry was not effective in reducing foot ulceration. Importantly, there was a higher rate of previous DFU in the intervention group, the adherence to thermometry was high, and the expected rates of DFU used in our sample size calculations were not met.  Trial registration : ClinicalTrials.gov NCT02373592 (27/02/2015).",2020,DFU cumulative incidence was 24% (19 of 79) in the intervention arm and 11% (9 of 79) in the control arm.,"['enrolling adults with type 2 diabetes mellitus at risk of foot ulcers (risk groups 2 or 3) but without foot ulcers at the time of recruitment and allocating them to', 'diabetic foot ulcers', '172 patients (63% women, mean age 61 years) were enrolled; 86 to each study group']","['control (instruction to use a liquid crystal-based foot thermometer daily) or intervention (same instruction supplemented with text and voice messages with reminders to use the device and messages to promote foot care', 'mHeath-based supplementation', ' ']","['history of DFU', 'Hazard Ratio (HR) for DFU', 'DFU cumulative incidence', 'diabetic foot ulcers (DFUs) incidence', 'time to occurrence of DFU']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0085119', 'cui_str': 'Ulcer of foot'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C1456868', 'cui_str': 'Diabetic foot ulcer'}, {'cui': 'C4517601', 'cui_str': '172'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0302603', 'cui_str': 'Liquid Crystals'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0039818', 'cui_str': 'Thermometer'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0150240', 'cui_str': 'Foot care'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1456868', 'cui_str': 'Diabetic foot ulcer'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}]",172.0,0.219747,DFU cumulative incidence was 24% (19 of 79) in the intervention arm and 11% (9 of 79) in the control arm.,"[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Lazo-Porras', 'Affiliation': 'CRONICAS Centre of Excellence in Chronic Diseases, Universidad Peruana Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Bernabe-Ortiz', 'Affiliation': 'CRONICAS Centre of Excellence in Chronic Diseases, Universidad Peruana Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Taype-Rondan', 'Affiliation': 'CRONICAS Centre of Excellence in Chronic Diseases, Universidad Peruana Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Gilman', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'German', 'Initials': 'G', 'LastName': 'Malaga', 'Affiliation': 'CRONICAS Centre of Excellence in Chronic Diseases, Universidad Peruana Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Helard', 'Initials': 'H', 'LastName': 'Manrique', 'Affiliation': 'Endocrinology Service, Hospital Nacional Arzobispo Loayza, Lima, Peru.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Neyra', 'Affiliation': 'Endocrinology Service, Hospital Nacional Arzobispo Loayza, Lima, Peru.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Calderon', 'Affiliation': 'Endocrinology Service, Hospital Nacional Arzobispo Loayza, Lima, Peru.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Pinto', 'Affiliation': 'Endocrinology Service, Hospital Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Armstrong', 'Affiliation': 'Southwestern Academic Limb Salvage Alliance (SALSA), Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles, California, USA.'}, {'ForeName': 'Victor M', 'Initials': 'VM', 'LastName': 'Montori', 'Affiliation': 'Knowledge and Evaluation Research Unit, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'J Jaime', 'Initials': 'JJ', 'LastName': 'Miranda', 'Affiliation': 'CRONICAS Centre of Excellence in Chronic Diseases, Universidad Peruana Cayetano Heredia, Lima, Peru.'}]",Wellcome open research,['10.12688/wellcomeopenres.15531.2']
2696,32920135,"Therapeutic effects of andiroba (Carapa guianensis Aubl) oil, compared to low power laser, on oral mucositis in children underwent chemotherapy: A clinical study.","ETHNO-PHARMACOLOGICAL RELEVANCE


The Carapa guianensis Aubl, popularly known as andiroba, is a large tree of the Meliaceae family, commonly found in the Amazon region. The oil extracted from its seeds is recognized in traditional medicine and has high anti-inflammatory and analgesic potential, which are the basic prerequisites for a therapeutic agent that can be used in the treatment of oral mucositis (OM). Moreover, the aforementioned oil has antimicrobial, antiallergic, and parasiticidal actions and is effective in the management of cutaneous and muscular dysfunctions.
AIM OF THE STUDY


To evaluate the therapeutic effects of andiroba gel (Carapa guianensis Aubl) on the symptomatology and evolution of OM in children with leukemia who underwent chemotherapy and to compare it to the effects of low power laser.
MATERIALS AND METHODS


This randomized, double-blind clinical trial involved 60 patients of both genders with leukemia, with age ranging from six to twelve years. The patients were divided into two study groups: the andiroba group (n = 30) and the laser group (n = 30). The level of pain experienced by the patients was assessed using the Wong-Baker visual analog scale and the degree of severity of OM was assessed using a table, recommended by the World Health Organization, that depicts the degrees of severity of OM. The data obtained were analyzed using the Mann-Whitney test, with statistical significance indicated by a P value less than or equal to 0.05.
RESULTS


A statistically significant reduction in the degree of OM was observed on the fourth, fifth, and sixth days and in the pain scores on the second, third, and fourth days in the andiroba group after the manifestation of OM, compared to the laser group.
CONCLUSIONS


The use of andiroba oil effectively reduced the severity of OM and relieved pain, which resulted in a decrease in the severity of signs and symptoms in the patients in the andiroba group, compared to the laser group.",2020,"RESULTS


A statistically significant reduction in the degree of OM was observed on the fourth, fifth, and sixth days and in the pain scores on the second, third, and fourth days in the andiroba group after the manifestation of OM, compared to the laser group.
","['children underwent', 'children with leukemia who underwent', '60 patients of both genders with leukemia, with age ranging from six to twelve years']","['andiroba gel (Carapa guianensis Aubl', 'chemotherapy', 'andiroba (Carapa guianensis Aubl) oil']","['Baker visual analog scale and the degree of severity of OM', 'degree of OM', 'severity of OM and relieved pain', 'level of pain', 'pain scores', 'severity of signs and symptoms', 'oral mucositis', 'symptomatology and evolution of OM']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0023418', 'cui_str': 'Leukemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C1258042', 'cui_str': 'Carapa'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0028908', 'cui_str': 'Oil'}]","[{'cui': 'C0238749', 'cui_str': 'Baker, general'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0441982', 'cui_str': 'Degrees of severity'}, {'cui': 'C0038362', 'cui_str': 'Stomatitis'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0015219', 'cui_str': 'Biological Evolution'}]",60.0,0.0241249,"RESULTS


A statistically significant reduction in the degree of OM was observed on the fourth, fifth, and sixth days and in the pain scores on the second, third, and fourth days in the andiroba group after the manifestation of OM, compared to the laser group.
","[{'ForeName': 'Artur Dos Santos', 'Initials': 'ADS', 'LastName': 'Soares', 'Affiliation': 'Department of Odontology, Federal University of Pará, Street Augusto Corrêa, Number 01, 66075-110, Belém, PA, Brazil. Electronic address: artur_soares_@hotmail.com.'}, {'ForeName': 'Ana Márcia Viana', 'Initials': 'AMV', 'LastName': 'Wanzeler', 'Affiliation': 'Department of Odontology, Federal University of Pará, Street Augusto Corrêa, Number 01, 66075-110, Belém, PA, Brazil. Electronic address: marciawanzeler@hotmail.com.'}, {'ForeName': 'Gabriel Henrique Soares', 'Initials': 'GHS', 'LastName': 'Cavalcante', 'Affiliation': 'Department of Odontology, Federal University of Pará, Street Augusto Corrêa, Number 01, 66075-110, Belém, PA, Brazil. Electronic address: gabrielhscavalcante@gmail.com.'}, {'ForeName': 'Elsa Maria da Silva', 'Initials': 'EMDS', 'LastName': 'Barros', 'Affiliation': 'Radiotherapy Service of Hospital Ophir Loyola, Avenue. Gov Magalhães Barata, Number 992, 66060-281, Belém, PA, Brazil. Electronic address: elsabarros12345@gmail.com.'}, {'ForeName': 'Rita de Cássia Matos', 'Initials': 'RCM', 'LastName': 'Carneiro', 'Affiliation': 'Radiotherapy Service of Hospital Ophir Loyola, Avenue. Gov Magalhães Barata, Number 992, 66060-281, Belém, PA, Brazil. Electronic address: ritacarneiro69@yahoo.com.br.'}, {'ForeName': 'Fabrício Mesquita', 'Initials': 'FM', 'LastName': 'Tuji', 'Affiliation': 'Department of Odontology, Federal University of Pará, Street Augusto Corrêa, Number 01, 66075-110, Belém, PA, Brazil; Radiotherapy Service of Hospital Ophir Loyola, Avenue. Gov Magalhães Barata, Number 992, 66060-281, Belém, PA, Brazil. Electronic address: fmtuji@gmail.com.'}]",Journal of ethnopharmacology,['10.1016/j.jep.2020.113365']
2697,32910720,Predicting Response to Vocabulary Intervention Using Dynamic Assessment.,"Purpose The purpose of this study was to examine how well students' response to a morphological vocabulary intervention can be predicted before the start of the intervention from traditional static assessments and to determine whether a dynamic assessment with graduated prompts improves the prediction. Method A planned secondary analysis of a randomized trial of a morphological vocabulary intervention for fifth-grade students with limited vocabulary was conducted. Response to this intervention was examined for 111 participants based on their development in definitions of morphologically transparent words from pretest to posttest. Traditional static measures of vocabulary, knowledge of morphology, and morphological analysis as well as a dynamic assessment of morphological analysis were evaluated as predictors of students' response to intervention. Results The static pretest measures predicted more than half of the overall variance in students' response to intervention and provided a good classification of students with subsequent poor or good response to intervention. The single best static predictor was the static assessment of morphological analysis. Furthermore, the dynamic assessment added significantly to the prediction of the overall variance in students' response to intervention and to the correct early classification of students as poor or good responders. Conclusions The results suggest that an acceptable level of prediction of students' response to morphological vocabulary intervention can be obtained by means of a couple of static morphological measures. This study also provides evidence for the added predictive value of a dynamic assessment of morphological analysis.",2020,The results suggest that an acceptable level of prediction of students' response to morphological vocabulary intervention can be obtained by means of a couple of static morphological measures.,"['111 participants based on their development in definitions of morphologically transparent words from pretest to posttest', 'fifth-grade students with limited vocabulary was conducted']",['morphological vocabulary intervention'],"['Traditional static measures of vocabulary, knowledge of morphology, and morphological analysis']","[{'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0522503', 'cui_str': 'Translucent'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0205439', 'cui_str': 'Fifth'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0543482', 'cui_str': 'morphology'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}, {'cui': 'C0543482', 'cui_str': 'morphology'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]",111.0,0.0206373,The results suggest that an acceptable level of prediction of students' response to morphological vocabulary intervention can be obtained by means of a couple of static morphological measures.,"[{'ForeName': 'Anna S', 'Initials': 'AS', 'LastName': 'Gellert', 'Affiliation': 'Department of Nordic Studies and Linguistics, University of Copenhagen, Denmark.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Arnbak', 'Affiliation': 'Danish School of Education, Aarhus University, Denmark.'}]","Language, speech, and hearing services in schools",['10.1044/2020_LSHSS-20-00045']
2698,32910735,Validation of a Novel Wearable Electromyography Patch for Monitoring Submental Muscle Activity During Swallowing: A Randomized Crossover Trial.,"Purpose Surface electromyography (sEMG) is often used for biofeedback during swallowing rehabilitation. However, commercially available sEMG electrodes are not optimized for the head and neck area, have rigid form, and are mostly available in large medical centers. We developed an ultrathin, soft, and flexible sEMG patch, specifically designed to conform to the submental anatomy and which will be ultimately incorporated into a telehealth system. To validate this first-generation sEMG patch, we compared its safety, efficiency, and signal quality in monitoring submental muscle activity with that of widely used conventional sEMG electrodes. Method A randomized crossover design was used to compare the experimental sEMG patch with conventional (snap-on) sEMG electrodes. Participants completed the same experimental protocol with both electrodes in counterbalanced order. Swallow trials included five trials of 5- and 10-ml water. Comparisons were made on (a) signal-related factors: signal-to-noise ratio (SNR), baseline amplitude, normalized mean amplitude, and sEMG burst duration and (b) safety/preclinical factors: safety/adverse effects, efficiency of electrode placement, and satisfaction/comfort. Noninferiority and equivalence tests were used to examine signal-related factors. Paired  t  tests and descriptive statistics were used to examine safety/preclinical factors. Results Forty healthy adults participated (24 women,  M   age  = 67.5 years). Signal-related factors: SNR of the experimental patch was not inferior to the SNR of the conventional electrodes ( p  < .0056). Similarly, baseline amplitude obtained with the experimental patch was not inferior to that obtained with conventional electrodes ( p  < .0001). Finally, normalized amplitude values were equivalent across swallows (5 ml:  p  < .025; 10 ml:  p  < .0012), and sEMG burst duration was also equivalent (5 ml:  p  < .0001; 10 ml:  p  < .0001). Safety/preclinical factors: The experimental patch resulted in fewer mild adverse effects. Participant satisfaction was higher with the experimental patch ( p  = .0476,  d  = 0.226). Conclusions Our new wearable sEMG patch is equivalent with widely used conventional sEMG electrodes in terms of technical performance. In addition, our patch is safe, and healthy older adults are satisfied with it. With lessons learned from the current COVID-19 pandemic, efforts to develop optimal swallowing telerehabilitation devices are more urgent than ever. Upon further validation, this new technology has the potential to improve rehabilitation and telerehabilitation efforts for patients with dysphagia. Supplemental Material https://doi.org/10.23641/asha.12915509.",2020,"Similarly, baseline amplitude obtained with the experimental patch was not inferior to that obtained with conventional electrodes ( p  < .0001).","['During Swallowing', 'Forty healthy adults participated (24 women,  M   age  = 67.5 years', 'patients with dysphagia', 'healthy older adults']","['Surface electromyography (sEMG', 'sEMG patch with conventional (snap-on) sEMG electrodes', 'Novel Wearable Electromyography Patch']","['sEMG burst duration', 'normalized amplitude values', 'Safety/preclinical factors', 'mild adverse effects', 'signal-related factors: signal-to-noise ratio (SNR), baseline amplitude, normalized mean amplitude, and sEMG burst duration and (b) safety/preclinical factors: safety/adverse effects, efficiency of electrode placement, and satisfaction/comfort', 'Participant satisfaction', 'Monitoring Submental Muscle Activity', 'safety, efficiency, and signal quality']","[{'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0430815', 'cui_str': 'Surface EMG'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C1177045', 'cui_str': 'Snap'}, {'cui': 'C0013812', 'cui_str': 'Electrode'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}]","[{'cui': 'C0430815', 'cui_str': 'Surface EMG'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C2986823', 'cui_str': 'Signal-To-Noise Ratio'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0013812', 'cui_str': 'Electrode'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0332306', 'cui_str': 'Quality'}]",40.0,0.0897228,"Similarly, baseline amplitude obtained with the experimental patch was not inferior to that obtained with conventional electrodes ( p  < .0001).","[{'ForeName': 'Cagla', 'Initials': 'C', 'LastName': 'Kantarcigil', 'Affiliation': 'Department of Speech, Language, and Hearing Sciences, Purdue University, West Lafayette, IN.'}, {'ForeName': 'Min Ku', 'Initials': 'MK', 'LastName': 'Kim', 'Affiliation': 'School of Biomedical Engineering, Purdue University, West Lafayette, IN.'}, {'ForeName': 'Taehoo', 'Initials': 'T', 'LastName': 'Chang', 'Affiliation': 'School of Materials Engineering, Purdue University, West Lafayette, IN.'}, {'ForeName': 'Bruce A', 'Initials': 'BA', 'LastName': 'Craig', 'Affiliation': 'Department of Statistics, Purdue University, West Lafayette, IN.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Smith', 'Affiliation': 'Department of Speech, Language, and Hearing Sciences, Purdue University, West Lafayette, IN.'}, {'ForeName': 'Chi Hwan', 'Initials': 'CH', 'LastName': 'Lee', 'Affiliation': 'School of Biomedical Engineering, Purdue University, West Lafayette, IN.'}, {'ForeName': 'Georgia A', 'Initials': 'GA', 'LastName': 'Malandraki', 'Affiliation': 'Department of Speech, Language, and Hearing Sciences, Purdue University, West Lafayette, IN.'}]","Journal of speech, language, and hearing research : JSLHR",['10.1044/2020_JSLHR-20-00171']
2699,32911981,Permanent His Bundle Pacing Implantation Facilitated by Visualization of the Tricuspid Valve Annulus.,"BACKGROUND


His bundle pacing (HBP) is the most physiological pacing modality. However, HBP has longer procedure times with frequent high capture thresholds, which likely contributes to the low adoption of this approach. The aim of this study is to compare HBP implantation with a novel imaging technique versus the standard implantation technique.
METHODS


This study included 50 patients with standard pacing indications randomized to HBP with visualization of the tricuspid valve annulus (N=25, the visualization group) or with the standard method (N=25, the control group). In the visualization group, the tricuspid valve annulus was imaged by contrast injection in the right ventricle during fluoroscopy. The site for HBP was identified in relationship to the tricuspid septal leaflet and interventricular septum.
RESULTS


Permanent HBP was successful in 92% in the visualization group and 88% in the control group. The fluoroscopic time for HBP lead placement was significantly shorter in the visualization group (7.1±3.3 minutes) compared with the control group (10.1±5.6 minutes,  P =0.03). Total procedural and fluoroscopic times were also significantly shorter in the visualization group (91.0±15.7 and 9.6±3.8 minutes) than the control group (104.4±17.8 and 12.7±6.2 minutes,  P =0.01 and 0.04, respectively). There was no significant difference in capture threshold between groups. In the visualization group, there was a quantitative association between the HBP site and the tricuspid valve annulus.
CONCLUSIONS


The visualization technique shortens the procedural and fluoroscopic times for HBP implantation. Moreover, anatomic localization of HBP sites is strongly associated with physiological characteristics of pacing, which can help guide optimal lead placement. Registration: URL: https://www.chictr.org.cn/index.aspx. Unique identifier: ChiCTR2000029834.",2020,"Total procedural and fluoroscopic times were also significantly shorter in the visualization group (91.0±15.7min and 9.6±3.8min) than the control group (104.4±17.8min and 12.7±6.2min, P=0.01 and 0.04, respectively).",['50 patients with standard pacing indications randomized to'],"['HBP implantation with a novel imaging technique versus the standard implantation technique', 'TVA', 'His bundle pacing (HBP', 'HBP with visualization of the tricuspid valve annulus (TVA, N=25, the visualization group) or with the standard method', 'HBP']","['fluoroscopic time for HBP lead placement', 'Total procedural and fluoroscopic times']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0562458', 'cui_str': 'Pacing up and down'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}]","[{'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0562458', 'cui_str': 'Pacing up and down'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0225926', 'cui_str': 'Structure of anulus fibrosus of tricuspid orifice'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",50.0,0.0224901,"Total procedural and fluoroscopic times were also significantly shorter in the visualization group (91.0±15.7min and 9.6±3.8min) than the control group (104.4±17.8min and 12.7±6.2min, P=0.01 and 0.04, respectively).","[{'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Gu', 'Affiliation': 'The Cardiac Arrhythmia Center, State Key Laboratory of Cardiovascular Disease, National Clinical Research Center of Cardiovascular Diseases, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China (M.G., H.N., Y.H., X.L., N.Z., M.C., X.C., W.H., S.Z.).'}, {'ForeName': 'Hongxia', 'Initials': 'H', 'LastName': 'Niu', 'Affiliation': 'The Cardiac Arrhythmia Center, State Key Laboratory of Cardiovascular Disease, National Clinical Research Center of Cardiovascular Diseases, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China (M.G., H.N., Y.H., X.L., N.Z., M.C., X.C., W.H., S.Z.).'}, {'ForeName': 'Yiran', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'The Cardiac Arrhythmia Center, State Key Laboratory of Cardiovascular Disease, National Clinical Research Center of Cardiovascular Diseases, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China (M.G., H.N., Y.H., X.L., N.Z., M.C., X.C., W.H., S.Z.).'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'The Cardiac Arrhythmia Center, State Key Laboratory of Cardiovascular Disease, National Clinical Research Center of Cardiovascular Diseases, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China (M.G., H.N., Y.H., X.L., N.Z., M.C., X.C., W.H., S.Z.).'}, {'ForeName': 'Nixiao', 'Initials': 'N', 'LastName': 'Zhang', 'Affiliation': 'The Cardiac Arrhythmia Center, State Key Laboratory of Cardiovascular Disease, National Clinical Research Center of Cardiovascular Diseases, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China (M.G., H.N., Y.H., X.L., N.Z., M.C., X.C., W.H., S.Z.).'}, {'ForeName': 'Minsi', 'Initials': 'M', 'LastName': 'Cai', 'Affiliation': 'The Cardiac Arrhythmia Center, State Key Laboratory of Cardiovascular Disease, National Clinical Research Center of Cardiovascular Diseases, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China (M.G., H.N., Y.H., X.L., N.Z., M.C., X.C., W.H., S.Z.).'}, {'ForeName': 'Xuhua', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'The Cardiac Arrhythmia Center, State Key Laboratory of Cardiovascular Disease, National Clinical Research Center of Cardiovascular Diseases, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China (M.G., H.N., Y.H., X.L., N.Z., M.C., X.C., W.H., S.Z.).'}, {'ForeName': 'Xiaohong', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Cardiac Rhythm Heart Failure, Medtronic, plc, Minneapolis, MN (X.Z.).'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Gold', 'Affiliation': 'Division of Cardiology, Medical University of South Carolina, Charleston (M.R.G.).'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Hua', 'Affiliation': 'The Cardiac Arrhythmia Center, State Key Laboratory of Cardiovascular Disease, National Clinical Research Center of Cardiovascular Diseases, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China (M.G., H.N., Y.H., X.L., N.Z., M.C., X.C., W.H., S.Z.).'}, {'ForeName': 'Shu', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'The Cardiac Arrhythmia Center, State Key Laboratory of Cardiovascular Disease, National Clinical Research Center of Cardiovascular Diseases, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China (M.G., H.N., Y.H., X.L., N.Z., M.C., X.C., W.H., S.Z.).'}]",Circulation. Arrhythmia and electrophysiology,['10.1161/CIRCEP.120.008370']
2700,32912091,Factors Associated With Participation in the Chronic Disease Self-Management Program: Findings From the SUCCEED Trial.,"BACKGROUND AND PURPOSE


Self-management programs may improve quality of life and self-efficacy for stroke survivors, but participation is low. In a randomized controlled trial of a complex, multidisciplinary, team-based secondary stroke prevention intervention, we offered participants Chronic Disease Self-Management Program (CDSMP) workshops in addition to clinic visits and home visits. To enhance participation, workshops were facilitated by community health workers who were culturally and linguistically concordant with most participants and scheduled CDSMP sessions at convenient venues and times. Over time, we implemented additional strategies such as free transportation and financial incentives. In this study, we aimed to determine factors associated with CDSMP participation and attendance.
METHODS


From 2014 to 2018, 18 CDSMP workshop series were offered to 241 English and Spanish-speaking individuals (age ≥40 years) with recent stroke or transient ischemic attack. Zero-inflated Poisson regression was used to identify factors associated with participation and attendance (ie, number of sessions attended) in CDSMP. Missing values were imputed using multiple imputation methods.
RESULTS


Nearly one-third (29%) of intervention subjects participated in CDSMP. Moderate disability and more clinic/home visits were associated with participation. Participants with higher numbers of clinic and home visits (incidence rate ratio [IRR], 1.06 [95% CI, 1.01-1.12]), severe (IRR, 2.34 [95% CI, 1.65-3.31]), and moderately severe disability (IRR, 1.55 [95% CI, 1.07-2.23]), and who enrolled later in the study (IRR, 1.12 [95% CI, 1.08-1.16]) attended more sessions. Individuals with higher chaos scores attended fewer sessions (IRR, 0.97 [95% CI, 0.95-0.99]).
CONCLUSIONS


Less than one-third of subjects enrolled in the SUCCEED (Secondary Stroke Prevention by Uniting Community and Chronic Care Model Teams Early to End Disparities) intervention participated in CDSMP; however, participation improved as transportation and financial barriers were addressed. Strategies to address social determinants of health contributing to chaos and engage individuals in healthcare may facilitate attendance. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01763203.",2020,"Participants with higher numbers of clinic and home visits (incidence rate ratio [IRR], 1.06 [95% CI, 1.01-1.12]), severe (IRR, 2.34 [95% CI, 1.65-3.31]), and moderately severe disability (IRR, 1.55 [95% CI, 1.07-2.23]), and who enrolled later in the study (IRR, 1.12 [95% CI, 1.08-1.16]) attended more sessions.","['From 2014 to 2018, 18 CDSMP workshop series were offered to 241 English and Spanish-speaking individuals (age ≥40 years) with recent stroke or transient ischemic attack', 'Chronic Disease Self-Management Program', 'participants Chronic Disease Self-Management Program (CDSMP) workshops in addition to clinic visits and home visits']","['complex, multidisciplinary, team-based secondary stroke prevention intervention']","['quality of life and self-efficacy', 'Moderate disability and more clinic/home visits', 'severe disability']","[{'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0205549', 'cui_str': 'Series'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}, {'cui': 'C0020043', 'cui_str': 'Home visit'}]","[{'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1277289', 'cui_str': 'Stroke prevention'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0020043', 'cui_str': 'Home visit'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",,0.0711493,"Participants with higher numbers of clinic and home visits (incidence rate ratio [IRR], 1.06 [95% CI, 1.01-1.12]), severe (IRR, 2.34 [95% CI, 1.65-3.31]), and moderately severe disability (IRR, 1.55 [95% CI, 1.07-2.23]), and who enrolled later in the study (IRR, 1.12 [95% CI, 1.08-1.16]) attended more sessions.","[{'ForeName': 'Amy M', 'Initials': 'AM', 'LastName': 'Lin', 'Affiliation': 'Department of Neurology, University of Southern California (A.M.L., M.A.-R., T.S.-T., N.S., A.T.), Los Angeles.'}, {'ForeName': 'Barbara G', 'Initials': 'BG', 'LastName': 'Vickrey', 'Affiliation': 'Department of Neurology, Icahn School of Medicine at Mount Sinai, New York (B.G.V.).'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Barry', 'Affiliation': 'Department of Neurology (F.B., M.L.L., B.M.), University of California, Los Angeles.'}, {'ForeName': 'Martin L', 'Initials': 'ML', 'LastName': 'Lee', 'Affiliation': 'Department of Neurology (F.B., M.L.L., B.M.), University of California, Los Angeles.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Ayala-Rivera', 'Affiliation': 'Department of Neurology, University of Southern California (A.M.L., M.A.-R., T.S.-T., N.S., A.T.), Los Angeles.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Cheng', 'Affiliation': 'VA Greater Los Angeles Healthcare System, CA (M.L.L., E.C.).'}, {'ForeName': 'Ana V', 'Initials': 'AV', 'LastName': 'Montoya', 'Affiliation': 'Department of Neurology, Harbor-UCLA Medical Center, Torrance, CA (A.V.M., J.L.T., B.M.).'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Mojarro-Huang', 'Affiliation': 'Department of Neurology, LAC+USC Medical Center (M.A.-R., E.M.-H., M.C., N.S., A.T.), Los Angeles.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Gomez', 'Affiliation': 'Department of Neurology, Rancho Los Amigos National Rehabilitation Center, Downey, CA (M.A.-R., P.G., M.C., M.C., T.S.-T., R.J., C.E., A.T., T.D., A.R.).'}, {'ForeName': 'Marissa', 'Initials': 'M', 'LastName': 'Castro', 'Affiliation': 'Department of Neurology, LAC+USC Medical Center (M.A.-R., E.M.-H., M.C., N.S., A.T.), Los Angeles.'}, {'ForeName': 'Marilyn', 'Initials': 'M', 'LastName': 'Corrales', 'Affiliation': 'Department of Neurology, Rancho Los Amigos National Rehabilitation Center, Downey, CA (M.A.-R., P.G., M.C., M.C., T.S.-T., R.J., C.E., A.T., T.D., A.R.).'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Sivers-Teixeira', 'Affiliation': 'Department of Neurology, University of Southern California (A.M.L., M.A.-R., T.S.-T., N.S., A.T.), Los Angeles.'}, {'ForeName': 'Jamie L', 'Initials': 'JL', 'LastName': 'Tran', 'Affiliation': 'Department of Neurology, Harbor-UCLA Medical Center, Torrance, CA (A.V.M., J.L.T., B.M.).'}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Johnson', 'Affiliation': 'Department of Neurology, Rancho Los Amigos National Rehabilitation Center, Downey, CA (M.A.-R., P.G., M.C., M.C., T.S.-T., R.J., C.E., A.T., T.D., A.R.).'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Ediss', 'Affiliation': 'Department of Neurology, Rancho Los Amigos National Rehabilitation Center, Downey, CA (M.A.-R., P.G., M.C., M.C., T.S.-T., R.J., C.E., A.T., T.D., A.R.).'}, {'ForeName': 'Betty', 'Initials': 'B', 'LastName': 'Shaby', 'Affiliation': 'Department of Neurology (B.S.), Olive View-UCLA Medical Center, Sylmar, CA.'}, {'ForeName': 'Phyllis', 'Initials': 'P', 'LastName': 'Willis', 'Affiliation': 'Watts Labor Community Action Committee, Los Angeles, CA (P.W.).'}, {'ForeName': 'Nerses', 'Initials': 'N', 'LastName': 'Sanossian', 'Affiliation': 'Department of Neurology, University of Southern California (A.M.L., M.A.-R., T.S.-T., N.S., A.T.), Los Angeles.'}, {'ForeName': 'Bijal', 'Initials': 'B', 'LastName': 'Mehta', 'Affiliation': 'Department of Neurology (F.B., M.L.L., B.M.), University of California, Los Angeles.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Dutta', 'Affiliation': 'Department of Neurology, Rancho Los Amigos National Rehabilitation Center, Downey, CA (M.A.-R., P.G., M.C., M.C., T.S.-T., R.J., C.E., A.T., T.D., A.R.).'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Razmara', 'Affiliation': 'Department of Neurology, Rancho Los Amigos National Rehabilitation Center, Downey, CA (M.A.-R., P.G., M.C., M.C., T.S.-T., R.J., C.E., A.T., T.D., A.R.).'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Bryg', 'Affiliation': 'Department of Medicine (R.B.), University of California, Los Angeles.'}, {'ForeName': 'Shlee', 'Initials': 'S', 'LastName': 'Song', 'Affiliation': 'Department of Neurology, Cedars-Sinai Medical Center, Los Angeles, CA (S.S.).'}, {'ForeName': 'Amytis', 'Initials': 'A', 'LastName': 'Towfighi', 'Affiliation': 'Department of Neurology, University of Southern California (A.M.L., M.A.-R., T.S.-T., N.S., A.T.), Los Angeles.'}]",Stroke,['10.1161/STROKEAHA.119.028022']
2701,32903140,Age Dependency of the Prognostic Impact of Tumor Genomics in Localized Resectable  MYCN -Nonamplified Neuroblastomas. Report From the SIOPEN Biology Group on the LNESG Trials and a COG Validation Group.,"PURPOSE


For localized, resectable neuroblastoma without  MYCN  amplification, surgery only is recommended even if incomplete. However, it is not known whether the genomic background of these tumors may influence outcome.
PATIENTS AND METHODS


Diagnostic samples were obtained from 317 tumors, International Neuroblastoma Staging System stages 1/2A/2B, from 3 cohorts: Localized Neuroblastoma European Study Group I/II and Children's Oncology Group. Genomic data were analyzed using multi- and pangenomic techniques and fluorescence in-situ hybridization in 2 age groups (cutoff age, 18 months) and were quality controlled by the International Society of Pediatric Oncology European Neuroblastoma (SIOPEN) Biology Group.
RESULTS


Patients with stage 1 tumors had an excellent outcome (5-year event-free survival [EFS] ± standard deviation [SD], 95% ± 2%; 5-year overall survival [OS], 99% ± 1%). In contrast, patients with stage 2 tumors had a reduced EFS in both age groups (5-year EFS ± SD, 84% ± 3% in patients < 18 months of age and 75% ± 7% in patients ≥ 18 months of age). However, OS was significantly decreased only in the latter group (5-year OS ± SD in < 18months and ≥ 18months, 96% ± 2% and 81% ± 7%, respectively;  P  = .001). In < 18months, relapses occurred independent of segmental chromosome aberrations (SCAs); only 1p loss decreased EFS (5-year EFS ± SD in patients 1p loss and no 1p loss, 62% ± 13% and 87% ± 3%, respectively;  P  = .019) but not OS (5-year OS ± SD, 92% ± 8% and 97% ± 2%, respectively). In patients ≥ 18 months, only SCAs led to relapse and death, with 11q loss as the strongest marker (11q loss and no 11q loss: 5-year EFS ± SD, 48% ± 16% and 85% ± 7%,  P  = .033; 5-year OS ± SD, 46% ± 22% and 92% ± 6%,  P  = .038).
CONCLUSION


Genomic aberrations of resectable non- MYCN- amplified stage 2 neuroblastomas have a distinct age-dependent prognostic impact. Chromosome 1p loss is a risk factor for relapse but not for diminished OS in patients < 18 months, SCAs (especially 11q loss) are risk factors for reduced EFS and OS in those > 18months. In older patients with SCA, a randomized trial of postoperative chemotherapy compared with observation alone may be indicated.",2020,"Chromosome 1p loss is a risk factor for relapse but not for diminished OS in patients < 18 months, SCAs (especially 11q loss) are risk factors for reduced EFS and OS in those > 18months.","['older patients with SCA', 'Diagnostic samples were obtained from 317 tumors, International Neuroblastoma Staging System stages 1/2A/2B, from 3 cohorts']",['postoperative chemotherapy'],"['excellent outcome (5-year event-free survival [EFS] ± standard deviation [SD', 'EFS (5-year EFS ± SD', '5-year overall survival [OS', 'OS', 'relapse and death']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0027819', 'cui_str': 'Neuroblastoma'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}]","[{'cui': 'C1273551', 'cui_str': 'Postoperative chemotherapy'}]","[{'cui': 'C1961136', 'cui_str': 'Excellent'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.0953821,"Chromosome 1p loss is a risk factor for relapse but not for diminished OS in patients < 18 months, SCAs (especially 11q loss) are risk factors for reduced EFS and OS in those > 18months.","[{'ForeName': 'Inge M', 'Initials': 'IM', 'LastName': 'Ambros', 'Affiliation': ""Children's Cancer Research Institute, St Anna Kinderkrebsforschung, Vienna, Austria.""}, {'ForeName': 'Gian-Paolo', 'Initials': 'GP', 'LastName': 'Tonini', 'Affiliation': 'Paediatric Research Institute, Fondazione Città della Speranza, Neuroblastoma Laboratory, Padua, Italy.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Pötschger', 'Affiliation': ""Children's Cancer Research Institute, St Anna Kinderkrebsforschung, Vienna, Austria.""}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Gross', 'Affiliation': 'Pediatric Oncology Research, Department of Pediatrics, University Hospital, Lausanne, Switzerland.'}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Mosseri', 'Affiliation': 'Service de Biostatistiques, Institut Curie, Paris, France.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Beiske', 'Affiliation': 'Department of Pathology, Oslo University Hospital Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Ana P', 'Initials': 'AP', 'LastName': 'Berbegall', 'Affiliation': 'Department of Pathology, Medical School, University of Valencia-Fundación de Investigación del Hospital Clínico Universitario de Valencia, Valencia, Spain.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Bénard', 'Affiliation': 'Département de Biologie et de Pathologie Médicales, Service de Pathologie Moléculaire, Institut Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Bown', 'Affiliation': 'Northern Genetics Service, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Huib', 'Initials': 'H', 'LastName': 'Caron', 'Affiliation': ""Department of Pediatric Oncology, Emma Children's Hospital, Academic Medical Center, Amsterdam, the Netherlands.""}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Combaret', 'Affiliation': 'Centre Léon Bérard, Laboratoire de Recherche Translationnelle, Lyon, France.'}, {'ForeName': 'Jerome', 'Initials': 'J', 'LastName': 'Couturier', 'Affiliation': 'Unité de Génétique Somatique et Cytogénétique, Institut Curie, Paris, France.'}, {'ForeName': 'Raffaella', 'Initials': 'R', 'LastName': 'Defferrari', 'Affiliation': 'Department of Pathology, Istituto G. Gaslini, Genoa, Italy.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Delattre', 'Affiliation': 'INSERM U830, Laboratoire de Génétique et Biologie des Cancers, Paris, France.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Jeison', 'Affiliation': ""Ca-Cytogenetic Laboratory, Pediatric Hematology Oncology Department, Schneider Children's Medical Center of Israel, Petah Tikvah, Israel.""}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Kogner', 'Affiliation': ""Childhood Cancer Research Unit, Karolinska Institutet, Astrid Lindgren Children's Hospital, Stockholm, Sweden.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Lunec', 'Affiliation': 'Biosciences Institute, Newcastle University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Marques', 'Affiliation': 'Centro de Genética Humana, Instituto Nacional de Saude doutor Ricardo Jorge, Lisbon, Portugal.'}, {'ForeName': 'Tommy', 'Initials': 'T', 'LastName': 'Martinsson', 'Affiliation': 'Department of Clinical Genetics, Institute of Biomedicine, University of Gothenburg, Sahlgrenska University Hospital, Göteborg, Sweden.'}, {'ForeName': 'Katia', 'Initials': 'K', 'LastName': 'Mazzocco', 'Affiliation': 'Department of Pathology, Istituto G. Gaslini, Genoa, Italy.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Noguera', 'Affiliation': 'Department of Pathology, Medical School, University of Valencia-Fundación de Investigación del Hospital Clínico Universitario de Valencia, Valencia, Spain.'}, {'ForeName': 'Gudrun', 'Initials': 'G', 'LastName': 'Schleiermacher', 'Affiliation': 'INSERM U830, Laboratoire de Génétique et Biologie des Cancers, Paris, France.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Valent', 'Affiliation': 'Département de Biologie et de Pathologie Médicales, Service de Pathologie Moléculaire, Institut Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Van Roy', 'Affiliation': 'Center for Medical Genetics, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Villamon', 'Affiliation': 'Department of Pathology, Medical School, University of Valencia-Fundación de Investigación del Hospital Clínico Universitario de Valencia, Valencia, Spain.'}, {'ForeName': 'Dasa', 'Initials': 'D', 'LastName': 'Janousek', 'Affiliation': ""Children's Cancer Research Institute, St Anna Kinderkrebsforschung, Vienna, Austria.""}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Pribill', 'Affiliation': ""Children's Cancer Research Institute, St Anna Kinderkrebsforschung, Vienna, Austria.""}, {'ForeName': 'Evgenia', 'Initials': 'E', 'LastName': 'Glogova', 'Affiliation': ""Children's Cancer Research Institute, St Anna Kinderkrebsforschung, Vienna, Austria.""}, {'ForeName': 'Edward F', 'Initials': 'EF', 'LastName': 'Attiyeh', 'Affiliation': ""Division of Oncology, The Children's Hospital of Philadelphia, Philadelphia, PA.""}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Hogarty', 'Affiliation': ""Division of Oncology, The Children's Hospital of Philadelphia, Philadelphia, PA.""}, {'ForeName': 'Tom F', 'Initials': 'TF', 'LastName': 'Monclair', 'Affiliation': 'Section for Paediatric Surgery, Division of Surgery, Rikshospitalet University Hospital, Oslo, Norway.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Holmes', 'Affiliation': ""Department of Paediatric Surgery, St George's Hospital, London, UK.""}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Valteau-Couanet', 'Affiliation': ""Département de Cancérologie de l'Enfant et de l'Adolescent, Gustave Roussy, Villejuif, France.""}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Castel', 'Affiliation': 'Unidad de Oncologia Pediatrica Hospital Universitario La Fe, Valencia, Spain.'}, {'ForeName': 'Deborah A', 'Initials': 'DA', 'LastName': 'Tweddle', 'Affiliation': 'Wolfson Childhood Cancer Research Centre, Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Julie R', 'Initials': 'JR', 'LastName': 'Park', 'Affiliation': ""Seattle Children's Hospital and University of Washington School of Medicine, Seattle, WA.""}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Cohn', 'Affiliation': 'Department of Pediatrics, The University of Chicago, Chicago, IL.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Ladenstein', 'Affiliation': ""Children's Cancer Research Institute, St Anna Kinderkrebsforschung, Vienna, Austria.""}, {'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'Beck-Popovic', 'Affiliation': 'Pediatric Hematology Oncology Unit, University Hospital of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'De Bernardi', 'Affiliation': ""Department of Paediatric Haematology and Oncology, Giannina Gaslini Children's Hospital, Genova, Italy.""}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Michon', 'Affiliation': 'Département de Pédiatrie, Institut Curie, Paris, France.'}, {'ForeName': 'Andrew D J', 'Initials': 'ADJ', 'LastName': 'Pearson', 'Affiliation': 'Institute of Cancer Research, Royal Marsden Hospital, Sutton, Surrey, United Kingdom.'}, {'ForeName': 'Peter F', 'Initials': 'PF', 'LastName': 'Ambros', 'Affiliation': ""Children's Cancer Research Institute, St Anna Kinderkrebsforschung, Vienna, Austria.""}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.18.02132']
2702,32903261,Impact of a pre-feeding oral stimulation program on first feed attempt in preterm infants: Double-blind controlled clinical trial.,"OBJECTIVE


To evaluate the effect of an oral stimulation program in preterm on the performance in the first oral feeding, oral feeding skills and transition time from tube to total oral intake.
STUDY DESIGNER


Double-blind randomized clinical trial including very preterm newborns. Congenital malformations, intracranial hemorrhage grade III or IV, bronchopulmonary dysplasia, and necrotizing enterocolitis were excluded. Intervention group (GI) received an oral stimulation program of tactile extra-, peri-, and intraoral tactile manipulation once a day for 15 minutes, during a 10-day period. Control group (GII) received sham procedure with same duration of time. Feeding ability was assessed by a speech-language pathologist blinded to group assignment. The classification of infants' oral performance was determined by Oral Feeding Skills (OFS). Neonates were monitored until hospital discharge.
RESULTS


Seventy-four (37 in each group) were randomized. Mean gestational ages and birth weights were 30±1.4 and 30±1.5 weeks, and 1,452±330g and 1,457±353g for intervention and control groups, respectively. Infants in the intervention group had significantly better rates than infants in the control group on: mean proficiency (PRO) (41.5%±18.3 vs. 19.9%±11.6 (p<0.001)), transfer rate (RT) (2.3 mL/min and 1.1 mL/min (p<0.001)) and overall transfer (OT) (57.2%±19.7 and 35.0%±15.7 (p<0.001)). Median transition time from tube to oral feeding was 4 (3-11) and 8 (7-13) days in intervention and control groups, respectively (p = 0.003). Intake of breast milk was found to reduce transition time from tube feeds to exclusive oral feeding (p<0.001, HR 1.01, 95%CI 1.005-1.019), but the impact of the study intervention remained significant (p = 0.007, HR 1.97, 95%CI 1.2-3.2).
CONCLUSION


Infants who were breast-fed and an oral stimulation program proved beneficial in reducing transition time from tube feeding to oral feeding.
TRIAL REGISTRATION


ClinicalTrials.gov number NCT03025815.",2020,"Intake of breast milk was found to reduce transition time from tube feeds to exclusive oral feeding (p<0.001, HR 1.01, 95%CI 1.005-1.019), but the impact of the study intervention remained significant (p = 0.007, HR 1.97, 95%CI 1.2-3.2).
","['preterm infants', 'very preterm newborns', 'Seventy-four (37 in each group) were randomized']","['Intervention group (GI) received an oral stimulation program of tactile extra-, peri-, and intraoral tactile manipulation', 'oral stimulation program', 'pre-feeding oral stimulation program']","['transition time', 'Mean gestational ages and birth weights', 'Median transition time from tube to oral feeding', 'overall transfer (OT', 'Feeding ability', 'mean proficiency (PRO', 'transfer rate (RT', 'Congenital malformations, intracranial hemorrhage grade III or IV, bronchopulmonary dysplasia, and necrotizing enterocolitis', 'better rates']","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C4517867', 'cui_str': '74'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439815', 'cui_str': 'Tactile'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0442119', 'cui_str': 'Intraoral approach'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0429944', 'cui_str': 'Feeding ability'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0151699', 'cui_str': 'Intracranial hemorrhage'}, {'cui': 'C0205617', 'cui_str': 'Poorly differentiated'}, {'cui': 'C0006287', 'cui_str': 'Bronchopulmonary dysplasia of newborn'}, {'cui': 'C0014356', 'cui_str': 'Enterocolitis'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}]",,0.179173,"Intake of breast milk was found to reduce transition time from tube feeds to exclusive oral feeding (p<0.001, HR 1.01, 95%CI 1.005-1.019), but the impact of the study intervention remained significant (p = 0.007, HR 1.97, 95%CI 1.2-3.2).
","[{'ForeName': 'Karine', 'Initials': 'K', 'LastName': 'da Rosa Pereira', 'Affiliation': 'Department of Speech-Language Pathology, Hospital de Clínicas de Porto Alegre, Porto Alegre, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Deborah Salle', 'Initials': 'DS', 'LastName': 'Levy', 'Affiliation': 'Department of Speech-Language Pathology, Hospital de Clínicas de Porto Alegre, Porto Alegre, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Renato S', 'Initials': 'RS', 'LastName': 'Procianoy', 'Affiliation': 'Department of Pediatrics, Universidade Federal do Rio Grande do Sul, Porto Alegre, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Rita C', 'Initials': 'RC', 'LastName': 'Silveira', 'Affiliation': 'Department of Pediatrics, Universidade Federal do Rio Grande do Sul, Porto Alegre, Rio Grande do Sul, Brazil.'}]",PloS one,['10.1371/journal.pone.0237915']
2703,32918519,Shared spiritual beliefs between adolescents with cancer and their families.,"BACKGROUND


FAmily CEntered (FACE) Advance Care Planning helps family decision makers to understand and honor patients' preferences for future health care, if patients cannot communicate. Spiritual well-being is a key domain of pediatric oncology care and an integral dimension of pediatric advance care planning.
PROCEDURE


As part of four-site randomized controlled trial of FACE for teens with cancer, the functional assessment of chronic illness therapy-spiritual well-being- version 4 (FACIT-Sp-EX-4) was completed independently by 126 adolescents with cancer/family dyads. The prevalence-adjusted and bias-adjusted kappa (PABAK) measured congruence on FACIT-Sp-EX-4.
RESULTS


Adolescents (126) had mean age of 16.9 years, were 57% female and 79% White. Religious/spiritual classifications were: Catholic (n = 18), Protestant (n = 76), Mormon (n = 3), none/atheist (n = 22), other (n = 5), and unknown (n = 2). Agreement at item level between spiritual well-being of adolescents and families was assessed. Three items had ≥90% agreement and Excellent PABAK: ""I have a reason for living,"" ""I feel loved,"" ""I feel compassion for others in the difficulties they are facing."" Three items had <61% agreement and Poor PABAK: ""I feel a sense of harmony within myself,"" ""My illness has strengthened my faith or spiritual beliefs,"" ""I feel connected to a higher power (or God)."" Dyadic congruence was compared by social-demographics using median one-way analysis. Male family members (median = 72%) were less likely to share spiritual beliefs with their adolescent than female family members (median = 83%), P = .0194.
CONCLUSIONS


Family members may not share spiritual beliefs with adolescents and may be unaware of the importance of spiritual well-being for adolescents.",2020,"Male family members (median = 72%) were less likely to share spiritual beliefs with their adolescent than female family members (median = 83%), P = .0194.
","['teens with cancer, the functional assessment of chronic illness therapy-spiritual well-being- version 4 (FACIT-Sp-EX-4) was completed independently by 126 adolescents with cancer/family dyads', 'adolescents with cancer and their families', 'Adolescents (126) had mean age of 16.9\xa0years, were 57% female and 79% White']","['FAmily CEntered (FACE', 'FACE']","['Dyadic congruence', 'prevalence-adjusted and bias-adjusted kappa (PABAK']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0439099', 'cui_str': 'Kappa'}]",126.0,0.0242359,"Male family members (median = 72%) were less likely to share spiritual beliefs with their adolescent than female family members (median = 83%), P = .0194.
","[{'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Livingston', 'Affiliation': 'Grant Thornton LLP, Arlington, Virginia.'}, {'ForeName': 'Yao I', 'Initials': 'YI', 'LastName': 'Cheng', 'Affiliation': 'Strategic Innovative Solutions LLC, Petersburg, Florida.'}, {'ForeName': 'Jichuan', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Division of Biostatistics and Study Methodology, Center for Translational Research at Children's National Hospital, Washington, District of Columbia.""}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Tweddle', 'Affiliation': ""Haslinger Family Pediatric Palliative Care Center, Akron Children's Hospital, Akron, Ohio.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Friebert', 'Affiliation': ""Haslinger Family Pediatric Palliative Care Center, Akron Children's Hospital, Akron, Ohio.""}, {'ForeName': 'Justin N', 'Initials': 'JN', 'LastName': 'Baker', 'Affiliation': ""Department of Oncology and Division of Quality of Life and Palliative Care, St Jude Children's Research Hospital, Memphis, Tennessee.""}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Thompkins', 'Affiliation': ""Center for Translational Research/Children's National Research Institute at Children's National Hospital, Washington, District of Columbia.""}, {'ForeName': 'Maureen E', 'Initials': 'ME', 'LastName': 'Lyon', 'Affiliation': 'George Washington University School of Medicine and Health Sciences, Washington, District of Columbia.'}]",Pediatric blood & cancer,['10.1002/pbc.28696']
2704,32916181,The effects of an exercise training on steroid hormones in preadolescent children - a moderator for enhanced cognition?,"OBJECTIVE


Research demonstrates a variety of cognitive benefits induced by different chronic physiological stressors (e.g. motor vs. cardiovascular exercise training) and acute exercise to affect steroid hormone secretion, the present study aims to investigate 1.) motor vs. cardiovascular exercise training and their impact on salivary Testosterone, Estradiol and Progesterone and 2.) whether alterations in steroid hormones might moderate exercise-induced cognitive benefits.
METHODS


In a randomized control trial, 71 preadolescent children (39 girls) at the age of 9-10 years were randomly assigned to a cardiovascular exercise group (CE), a motor exercise group (ME) as well as a control group (CON) in which students were attending assisted homework. The participants attended their program three times per week, for a total of 10 weeks. Steroid hormones in the saliva, working memory performance and state-trait anxiety levels were determined before and after the intervention.
RESULTS


Statistical analysis showed no chronic changes in hormones through the interventions. Stepwise hierarchical regression revealed the Testosterone*ME-interaction to be a significant moderator for working memory performance post-intervention (β = 0.48, p = 0.014). Within the ME, increases of Testosterone from t 1  to t 2  were predicting higher working memory performance post-intervention (β = 0.45, R 2  = 0.16, p = 0.038).
CONCLUSION


Our findings suggest 1.) that motor-exercise-induced cognitive benefits are moderated by changes in Testosterone and 2.) that a 10-week exercise training of moderate intensity and with a motor demanding vs a cardiovascular character does not affect the chronic concentration of salivary Testosterone, Estradiol and Progesterone nor anxiety levels in preadolescent children.",2020,"Stepwise hierarchical regression revealed the Testosterone*ME-interaction to be a significant moderator for working memory performance post-intervention (β = 0.48, p = 0.014).","['preadolescent children', '71 preadolescent children (39 girls) at the age of 9-10 years']","['cardiovascular exercise group (CE), a motor exercise group (ME) as well as a control group (CON', 'exercise training', 'motor vs. cardiovascular exercise training']","['salivary Testosterone, Estradiol and Progesterone and 2', 'saliva, working memory performance and state-trait anxiety levels', 'Testosterone', 'steroid hormones', 'chronic concentration of salivary Testosterone, Estradiol and Progesterone nor anxiety levels']","[{'cui': 'C1444711', 'cui_str': 'Pre-teen'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0301818', 'cui_str': 'Steroid hormone'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",71.0,0.0658097,"Stepwise hierarchical regression revealed the Testosterone*ME-interaction to be a significant moderator for working memory performance post-intervention (β = 0.48, p = 0.014).","[{'ForeName': 'Davin P', 'Initials': 'DP', 'LastName': 'Akko', 'Affiliation': 'Faculty of Human Sciences, Medical School Hamburg, Hamburg, Germany; Faculty of Humanities and Social Sciences, University of Hagen, Hagen, Germany. Electronic address: davin-patrick.akko@fernuni-hagen.de.'}, {'ForeName': 'Flora', 'Initials': 'F', 'LastName': 'Koutsandréou', 'Affiliation': 'Faculty of Human Sciences, Medical School Hamburg, Hamburg, Germany.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Murillo-Rodríguez', 'Affiliation': 'Escuela de Medicina, División Ciencias de la Salud, Universidad Anáhuac Mayab Mérida, Mérida, Yucatán, Mexico.'}, {'ForeName': 'Mirko', 'Initials': 'M', 'LastName': 'Wegner', 'Affiliation': 'Department of Sport Psychology, Institute of Sports Science, Humboldt University Berlin, Berlin, Germany.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Budde', 'Affiliation': 'Faculty of Human Sciences, Medical School Hamburg, Hamburg, Germany.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113168']
2705,32916236,"Radiation-induced lymphopenia during chemoradiation therapy for non-small cell lung cancer is linked with age, lung V5, and XRCC1 rs25487 genotypes in lymphocytes.","BACKGROUND & PURPOSE


We investigated clinical and genetic factors associated with severe radiation-induced lymphopenia (RIL) in a randomized clinical trial of photon vs. proton radiation, with chemotherapy, for non-small cell lung cancer.
METHODS


XRCC1 rs25487 was genotyped in lymphocytes from serial peripheral blood samples. Severe RIL was defined as absolute lymphocyte count (ALC) < 0.3 × 10 9  cells/L. Univariate and multivariate analyses were used to identify independent risk factors, which were then used to group patients for risk of severe RIL.
RESULTS


Univariate analysis of the 178 patients in this analysis showed that older age, larger tumors, higher lung V5 and mean lung dose, and higher heart V5 and mean heart dose were associated with severe RIL during treatment (P < 0.05). The XRCC1 rs25487 AA genotype was also associated with increased risk of severe RIL during treatment (AA vs. others: hazard ratio [HR] = 1.665, 95% confidence interval [CI] 1.089-2.500, P = 0.018). Multivariate analyses showed that older age (HR = 1.031, 95% CI 1.009-1.054, P = 0.005), lung V5 (HR = 1.039, 95% CI 1.023-1.055, P < 0.0001), and AA genotype (AA vs. others, HR = 1.768, 95% CI 1.165-2.684, P = 0.007) were independently associated with higher incidence of severe RIL. These three risk factors (age ≥ 56 years, lung V5 ≥ 51% and XRCC1 rs25487 AA) distinguished patients at different risk of developing severe RIL (P < 0.0001).
CONCLUSIONS


Age, lung V5 and XRCC1 rs25487 AA were all linked with risk of severe RIL. Our predictive risk model may be helpful for identifying patients at high risk of severe RIL so that treatment can be modified.",2020,"Multivariate analyses showed that older age (HR=1.031, 95% CI 1.009-1.054, P=0.005), lung V5 (HR=1.039, 95% CI 1.023-1.055, P<0.001), and AA genotype (AA vs. others, HR=1.768, 95% CI 1.165-2.684, P=0.007) were independently associated with higher incidence of severe RIL.",['XRCC1 rs25487 was genotyped in lymphocytes from serial peripheral blood samples'],"['Radiation-induced lymphopenia during chemoradiation therapy', 'photon vs. proton radiation, with chemotherapy']","['lung V5', 'Severe RIL', 'severe RIL', 'absolute lymphocyte count (ALC', 'risk of severe RIL']","[{'cui': 'C0250029', 'cui_str': 'XRCC1 protein, human'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0024312', 'cui_str': 'Lymphocytopenia'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0086805', 'cui_str': 'Photon'}, {'cui': 'C0033727', 'cui_str': 'Proton'}]","[{'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0024312', 'cui_str': 'Lymphocytopenia'}, {'cui': 'C3544087', 'cui_str': 'Absolute lymphocyte count'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",178.0,0.0968706,"Multivariate analyses showed that older age (HR=1.031, 95% CI 1.009-1.054, P=0.005), lung V5 (HR=1.039, 95% CI 1.023-1.055, P<0.001), and AA genotype (AA vs. others, HR=1.768, 95% CI 1.165-2.684, P=0.007) were independently associated with higher incidence of severe RIL.","[{'ForeName': 'Xiaoxue', 'Initials': 'X', 'LastName': 'Xie', 'Affiliation': 'Hunan Key Laboratory of Translational Radiation Oncology, Hunan Cancer Hospital, The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China.'}, {'ForeName': 'Steven H', 'Initials': 'SH', 'LastName': 'Lin', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, USA.'}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Welsh', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, USA.'}, {'ForeName': 'Xiong', 'Initials': 'X', 'LastName': 'Wei', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, USA.'}, {'ForeName': 'Hekun', 'Initials': 'H', 'LastName': 'Jin', 'Affiliation': 'Hunan Key Laboratory of Translational Radiation Oncology, Hunan Cancer Hospital, The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China.'}, {'ForeName': 'Radhe', 'Initials': 'R', 'LastName': 'Mohan', 'Affiliation': 'Department of Radiation Physics, The University of Texas MD Anderson Cancer Center, Houston, USA.'}, {'ForeName': 'Zhongxing', 'Initials': 'Z', 'LastName': 'Liao', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, USA.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Xu', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, USA. Electronic address: TXu@mdanderson.org.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2020.09.002']
2706,32917424,Adolescents as Agents of Parental Healthy Lifestyle Behavior Change: COPE Healthy Lifestyles TEEN Program.,"INTRODUCTION


Obesity is a leading health crisis around the world. An intervention strategy scarcely utilized for behavior change is that of a child as change agent. The purpose of this study was to describe the impact of teens reviewing newsletters from a healthy lifestyle intervention with their parents.
METHOD


Evaluation data from a randomized controlled trial, COPE Healthy Lifestyle TEEN Program, was analyzed. A descriptive study was conducted of parents' and teens' lifestyle behaviors as reported by parents.
RESULTS


One hundred sixty-nine parents completed evaluations. Two thirds of parents reported changing a behavior as a result of the program. Nearly three quarters of parents reported behavior changes in their teens. Over 90% reported they would recommend this or a similar program.
DISCUSSION


The obesity epidemic shows no signs of reversal, and hence multiple approaches to impact healthy lifestyles are urgent. Including children as a change agent is a potential target for interventions addressing obesity.",2020,Nearly three quarters of parents reported behavior changes in their teens.,"['Adolescents as Agents of Parental Healthy Lifestyle Behavior Change: COPE Healthy Lifestyles TEEN Program', ""parents' and teens' lifestyle behaviors as reported by parents"", 'One hundred sixty-nine parents completed evaluations', 'teens reviewing newsletters from a healthy lifestyle intervention with their parents']",[],['behavior changes'],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0450388', 'cui_str': '69'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0027988', 'cui_str': 'Newsletters'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],"[{'cui': 'C0542299', 'cui_str': 'Change in behavior'}]",169.0,0.0232846,Nearly three quarters of parents reported behavior changes in their teens.,"[{'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Kelly', 'Affiliation': ''}, {'ForeName': 'Bernadette Mazurek', 'Initials': 'BM', 'LastName': 'Melnyk', 'Affiliation': ''}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Hoying', 'Affiliation': ''}]",Journal of pediatric health care : official publication of National Association of Pediatric Nurse Associates & Practitioners,['10.1016/j.pedhc.2020.06.012']
2707,32920228,"The effect of pain neurophysiology education on healthcare students' knowledge, attitudes and behaviours towards pain: A mixed-methods randomised controlled trial.","OBJECTIVE


1) To investigate the effects of a brief pain neuroscience education (PNE) lecture on multi-disciplinary healthcare students' knowledge, attitudes and behaviours towards people with pain post intervention and at 6-months follow-up, 2) To explore students' perceptions of PNE.
DESIGN


Mixed-methods randomized controlled trial.
SETTING


UK university.
PARTICIPANTS


Thirty-seven students (30♀, mean age 30 years) from six healthcare disciplines.
INTERVENTION


70-min PNE lecture (intervention group) or a 70-min control education.
MAIN OUTCOME MEASURES


1) Knowledge: The Revised Pain Neurophysiology Quiz (RPNQ); 2) Attitudes: Health Care Providers' Pain and Impairment Relationship Scale (HC-PAIRS); 3) Behaviours: A case vignette to assess clinical recommendations; and 4) Thematic analysis of semi-structured interviews (n = 12).
RESULTS


The intervention group increased knowledge compared to the control, post-intervention [mean difference 3.7 (95% CI, 2.4, 5.0), P < 0.001] but not at 6-months (0.1 (-1.1, 1.3), P = 0.860). Greater improvements in attitudes for the intervention group were seen post-intervention [-10.4 (-16.3, -4.6), P < 0.001] and at 6-months [-5.8 (-11.5, -0.2), P < 0.044]. There was no difference in behaviours between groups. Thematic analysis identified increased patient empathy, partial and patchy reconceptualisation of pain and increased confidence in recommending an active management programme following PNE.
CONCLUSION


This study adds to existing knowledge by demonstrating that a 70-min PNE lecture can have a short-term effect on knowledge and positively shift attitudes towards people with pain in the short and medium-term. It also resulted in some students' reconceptualisation of pain, increased empathy, and confidence to recommend activity. The effect of PNE on clinical behaviours was unclear.",2020,"The intervention group increased knowledge compared to the control, post-intervention [mean difference 3.7 (95% CI, 2.4, 5.0), P < 0.001] but not at 6-months (0.1 (-1.1, 1.3), P = 0.860).","['UK university', 'healthcare students', 'Knowledge', 'Attitudes', 'Thirty-seven students (30♀, mean age 30 years) from six healthcare disciplines']","['pain neurophysiology education', 'pain neuroscience education (PNE) lecture', '70-min PNE lecture (intervention group) or a 70-min control education', 'PNE']","['knowledge', 'patient empathy, partial and patchy reconceptualisation of pain', ""Health Care Providers' Pain and Impairment Relationship Scale (HC-PAIRS"", 'knowledge, attitudes and behaviours towards pain', 'pain, increased empathy, and confidence to recommend activity']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C4319569', 'cui_str': '37'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0027901', 'cui_str': 'Neurophysiology'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0027910', 'cui_str': 'Neurosciences'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C3489398', 'cui_str': 'Peripheral neuroepithelioma'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0205413', 'cui_str': 'Patchy'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",,0.210237,"The intervention group increased knowledge compared to the control, post-intervention [mean difference 3.7 (95% CI, 2.4, 5.0), P < 0.001] but not at 6-months (0.1 (-1.1, 1.3), P = 0.860).","[{'ForeName': 'Jagjit', 'Initials': 'J', 'LastName': 'Mankelow', 'Affiliation': 'School of Health and Life Sciences, Teesside University, Middlesbrough, TS1 3BX, United Kingdom. Electronic address: j.mankelow@tees.ac.uk.'}, {'ForeName': 'Cormac', 'Initials': 'C', 'LastName': 'Ryan', 'Affiliation': 'School of Health and Life Sciences, Teesside University, Middlesbrough, TS1 3BX, United Kingdom.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Taylor', 'Affiliation': 'School of Social Sciences, Humanities and Law, Teesside University, Middlesbrough, TS1 3BX, United Kingdom.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Martin', 'Affiliation': 'School of Health and Life Sciences, Teesside University, Middlesbrough, TS1 3BX, United Kingdom.'}]",Musculoskeletal science & practice,['10.1016/j.msksp.2020.102249']
2708,32920241,"Sustaining the reach of a scalable weight loss intervention through financial incentives- a pragmatic, feasibility, online randomized trial protocol.","BACKGROUND


High attrition following initial enrollment in evidence-based weight loss programs is a common, challenging, and under-studied issue. A behavioral economics approach consisting of modest monetary incentives may help to engage participants beyond enrollment to close the initial attrition gap.
PURPOSE


To describe the methods and design of a pragmatic, online randomized controlled trial (RCT) of an incentivized, technology-facilitated weight loss program through an innovative research-practice partnership involving primary care, health promotion researchers, and a small business.
METHODS


This study is a four-arm (1:1:1:1) RCT that compares the efficacy of outcome-based (weight loss), process-based (weighing in), a combination of outcome- and process-based, or choice-based incentives on sustaining program reach after initial enrollment for an evidence-based weight loss program. The multicomponent weight loss program includes a website, social cognitive theory-based daily health coaching, tailored messaging delivered via email and text messaging, access to online health coaches, and objective weight assessment through a community kiosk. The study will enroll 400 individuals aged 19 and older who have a body mass index ≥25 kg/m 2 , and have reliable access to the Internet or a smart phone. Participants will be followed for 3, 6, 9, and 12 months to assess program reach and representativeness, and continued participation after enrollment. The secondary outcomes include weight loss and program implementation costs. We will conduct participant focus groups to understand the barriers and facilitators of participation and key informant interviews focusing on clinic managers and care providers to explore the potential for future adoption and implementation of the evidence-based program.
DISCUSSION


This study possesses the potential to close the attrition gap after initial enrollment in a web-based digital weight loss intervention in the primary care and community settings. Clinicaltrials.gov registration: NCT04225234.",2020,This study possesses the potential to close the attrition gap after initial enrollment in a web-based digital weight loss intervention in the primary care and community settings.,"['400 individuals aged 19 and older who have a body mass index ≥25\u202fkg/m 2 , and have reliable access to the Internet or a smart phone']",['RCT'],['weight loss and program implementation costs'],"[{'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",400.0,0.110561,This study possesses the potential to close the attrition gap after initial enrollment in a web-based digital weight loss intervention in the primary care and community settings.,"[{'ForeName': 'Tzeyu L', 'Initials': 'TL', 'LastName': 'Michaud', 'Affiliation': 'Center for Reducing Health Disparities, College of Public Health, University of Nebraska Medical Center, Omaha, NE, USA; Department of Health Promotion, College of Public Health, University of Nebraska Medical Center, Omaha, NE, USA. Electronic address: tzeyu.michaud@unmc.edu.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Estabrooks', 'Affiliation': 'Center for Reducing Health Disparities, College of Public Health, University of Nebraska Medical Center, Omaha, NE, USA; Department of Health Promotion, College of Public Health, University of Nebraska Medical Center, Omaha, NE, USA.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'You', 'Affiliation': 'Department of Public Health Sciences, University of Virginia, Charlottesville, VA, USA.'}, {'ForeName': 'Todd J', 'Initials': 'TJ', 'LastName': 'McGuire', 'Affiliation': 'incentaHEALTH, LLC, Denver, CO, USA.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Almeida', 'Affiliation': 'Center for Reducing Health Disparities, College of Public Health, University of Nebraska Medical Center, Omaha, NE, USA; Department of Health Promotion, College of Public Health, University of Nebraska Medical Center, Omaha, NE, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Karls', 'Affiliation': 'Fontenelle clinic, Nebraska Medicine, Omaha, Nebraska, NE, USA.'}, {'ForeName': 'Kenya', 'Initials': 'K', 'LastName': 'Love', 'Affiliation': 'Center for Reducing Health Disparities, College of Public Health, University of Nebraska Medical Center, Omaha, NE, USA.'}, {'ForeName': 'Keyonna', 'Initials': 'K', 'LastName': 'King', 'Affiliation': 'Center for Reducing Health Disparities, College of Public Health, University of Nebraska Medical Center, Omaha, NE, USA; Department of Health Promotion, College of Public Health, University of Nebraska Medical Center, Omaha, NE, USA.'}, {'ForeName': 'Jennie', 'Initials': 'J', 'LastName': 'Hill', 'Affiliation': 'Department of Epidemiology, College of Public Health, University of Nebraska Medical Center, Omaha, NE, USA.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Reed', 'Affiliation': 'College of Nursing, Kearney Division, University of Nebraska Medical Center, Omaha, NE, USA.'}, {'ForeName': 'Gwenndolyn', 'Initials': 'G', 'LastName': 'Porter', 'Affiliation': 'Department of Health Promotion, College of Public Health, University of Nebraska Medical Center, Omaha, NE, USA.'}, {'ForeName': 'Dejun', 'Initials': 'D', 'LastName': 'Su', 'Affiliation': 'Center for Reducing Health Disparities, College of Public Health, University of Nebraska Medical Center, Omaha, NE, USA; Department of Health Promotion, College of Public Health, University of Nebraska Medical Center, Omaha, NE, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106142']
2709,32920242,Comparing the clinical impact of pancreatic cyst surveillance programs: A trial of the ECOG-ACRIN cancer research group (EA2185).,"BACKGROUND


The optimal surveillance strategy for pancreatic cysts, which occur in up to 20% of the adult population, is ill defined. The risk of malignant degeneration of these cysts is low, however the morbidity and mortality associated with pancreatic cancer are high. Two clinical surveillance guidelines are in regular use. Both the Fukuoka and American Gastroenterological Association (AGA) guidelines rely on radiographic and endoscopic imaging. They differ primarily in their recommended frequencies of interval surveillance imaging. While evidence driven clinical guidelines should promote higher quality care, competing guidelines on the same topic may provide discordant recommendations and potential reduction in the quality and/or value of care.
OBJECTIVES


The primary objective is to compare the clinical effectiveness of the two surveillance guidelines to identify patients most likely to benefit from pancreatic resection. Secondary objectives include comparison of resource utilization, patient reported outcomes, incidental findings are other clinical outcomes.
METHODS


4606 asymptomatic patients with newly identified pancreatic cysts ≥1 cm in diameter will be randomized 1:1 to high intensity (Fukuoka) or low intensity (AGA) surveillance. All participants will be followed prospectively for 5 years.
CONCLUSION


Differing guidelines confuse providers, patients and policymakers. This large, prospective, randomized trial will compare the clinical effectiveness and resource allocation requirements of two guidelines addressing a common clinical entity. CLINICALTRIALS.
GOV IDENTIFIER


NCT04239573.",2020,"METHODS


4606 asymptomatic patients with newly identified pancreatic cysts ≥1 cm in diameter will be randomized 1:1 to high intensity (Fukuoka) or low intensity (AGA) surveillance.","['4606 asymptomatic patients with newly identified pancreatic cysts ≥1\u202fcm in diameter', 'All participants will be followed prospectively for 5\u202fyears']",['high intensity (Fukuoka) or low intensity (AGA) surveillance'],"['comparison of resource utilization, patient reported outcomes, incidental findings are other clinical outcomes']","[{'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0030283', 'cui_str': 'Cyst of pancreas'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}]","[{'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0743997', 'cui_str': 'Incidental Findings'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",4606.0,0.104339,"METHODS


4606 asymptomatic patients with newly identified pancreatic cysts ≥1 cm in diameter will be randomized 1:1 to high intensity (Fukuoka) or low intensity (AGA) surveillance.","[{'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Weinberg', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, PA, United States of America. Electronic address: David.weinberg@fccc.edu.'}, {'ForeName': 'Constantine', 'Initials': 'C', 'LastName': 'Gatsonis', 'Affiliation': 'Department of Biostatistics and Center for Statistical Sciences, Brown University School of Public Health, Providence, RI, United States of America.'}, {'ForeName': 'Herbert J', 'Initials': 'HJ', 'LastName': 'Zeh', 'Affiliation': 'UT Southwestern, Simmons Cancer Center, Dallas, TX, United States of America.'}, {'ForeName': 'Ruth C', 'Initials': 'RC', 'LastName': 'Carlos', 'Affiliation': 'University of Michigan, Ann Arbor, MI, United States of America.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': ""O'Dwyer"", 'Affiliation': 'University of Pennsylvania-Abramson Cancer Center, Philadelphia, PA, United States of America.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Contemporary clinical trials,['10.1016/j.cct.2020.106144']
2710,32931137,What is the risk of permanent stoma beyond 5 years after low anterior resection for rectal cancer? A 15-year follow-up of a randomized trial.,"AIM


Low anterior resection of the rectum for cancer (LAR) entails a risk of symptomatic anastomotic leakage as well as impaired anorectal function, both of which may eventually result in the need for a permanent stoma (PS). The aim was to investigate the incidence of and risk factors for PS beyond 5 years following LAR.
METHODS


Patients undergoing LAR and included in a multicentre trial with randomization to defunctioning stoma or not were followed for a median of 15 years. The reasons for a PS up to 5 years (PS ≤ 5 years) and beyond 5 years (PS > 5 years) were identified and compared. Risk factors for PS were analysed.
RESULTS


Of all patients, 25% (57/232) had a PS. PS ≤ 5 years occurred in 19% (44/232) at a median of 12.5 months and PS > 5 years in 6% (13/232) at a median of 118 months following LAR. The main reason for PS ≤ 5 years was impaired anorectal function in 55% (24/44) and the main reason for PS > 5 years was pelvic sepsis related to the colorectal anastomosis in 46% (6/13). The major risk factor for PS was symptomatic anastomotic leakage, which occurred in 56% (32/57) of patients with PS and 10% (17/175) of patients without PS (P < 0.001).
CONCLUSION


One-fourth of the patients who ended up with a PS had it fashioned beyond 5 years at a median of 10 years following LAR. Symptomatic anastomotic leakage was the major risk factor for PS, and impaired anorectal function was the main overall reason for a PS.",2020,"PS≤5years occurred in 19% (44/232) at a median of 12.5 months, and PS>5years in 6% (13/232) at a median of 118 months following LAR.",['Patients undergoing LAR and included in a multicentre trial with randomization to defunctioning stoma or not were followed for a median of 15 years'],[],"['anorectal function', 'symptomatic anastomotic leakage', 'Symptomatic anastomotic leakage']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0206012', 'cui_str': 'Multicentre Trials'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1955856', 'cui_str': 'Stoma site'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],"[{'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0919691', 'cui_str': 'Anastomotic leak'}]",,0.0786998,"PS≤5years occurred in 19% (44/232) at a median of 12.5 months, and PS>5years in 6% (13/232) at a median of 118 months following LAR.","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Gadan', 'Affiliation': 'Department of Surgery, Örebro University Hospital, Örebro, Sweden.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Floodeen', 'Affiliation': 'Department of Surgery, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Lindgren', 'Affiliation': 'Department of Surgery, Örebro University Hospital, Örebro, Sweden.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rutegård', 'Affiliation': 'Department of Surgical and Perioperative Sciences, Umeå University, Umeå, Sweden.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Matthiessen', 'Affiliation': 'Department of Surgery, Örebro University Hospital, Örebro, Sweden.'}]",Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland,['10.1111/codi.15364']
2711,32925593,Neural effects of placebo analgesia in fibromyalgia patients and healthy individuals.,"Placebo analgesia is hypothesized to involve top-down engagement of prefrontal regions that access endogenous pain inhibiting opioid pathways. Fibromyalgia (FM) patients have neuroanatomical and neurochemical alterations in pathways relevant to placebo analgesia. Thus, it remains unclear whether placebo analgesic mechanisms would differ in FM patients compared to healthy controls (HCs). Here, using placebo-analgesia-inducing paradigms that included verbal suggestions and conditioning manipulations, we examined whether behavioral and neural placebo analgesic responses differed between 32 FM patients and 46 age- and sex-matched HCs. Participants underwent a manipulation scan, where noxious high and low heat were paired with the control and placebo cream, respectively, and a placebo experimental scan with equal noxious heat temperatures. Before the experimental scan, each participant received saline or naloxone, an opioid receptor antagonist. Across all participants, the placebo condition decreased pain intensity and unpleasantness ratings, decreased activity within the right insula and bilateral secondary somatosensory cortex, and modulated the neurologic pain signature. There were no differences between HCs and FM patients in pain intensity ratings or neural responses during the placebo condition. Despite the perceptual and neural effects of the placebo manipulation, prefrontal circuitry was not activated during the expectation period and the placebo analgesia was unaltered by naloxone, suggesting placebo effects were driven more by conditioning than expectation. Together, these findings suggest that placebo analgesia can occur in both HCs and chronic pain FM patients, without the involvement of opioidergic prefrontal modulatory networks.",2020,"Across all participants, the placebo condition decreased pain intensity and unpleasantness ratings, decreased activity within the right insula and bilateral secondary somatosensory cortex, and modulated the Neurologic Pain Signature.","['32 FM patients and 46 age- and sex-matched HCs', 'fibromyalgia patients and healthy individuals']","['manipulation scan, where noxious high and low heat were paired with the control and placebo cream', 'saline or naloxone, an opioid receptor antagonist', 'placebo experimental scan with equal noxious heat temperatures', 'Placebo analgesia', 'placebo', 'placebo analgesia']","['pain intensity ratings or neural responses', 'pain intensity and unpleasantness ratings, decreased activity within the right insula and bilateral secondary somatosensory cortex, and modulated the Neurologic Pain Signature']","[{'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0947647', 'cui_str': 'Manipulation'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0027358', 'cui_str': 'Naloxone'}, {'cui': 'C0027410', 'cui_str': 'Opioid receptor antagonist'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0021640', 'cui_str': 'Insular structure'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C3496176', 'cui_str': 'Secondary Sensory Cortex'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}]",,0.333537,"Across all participants, the placebo condition decreased pain intensity and unpleasantness ratings, decreased activity within the right insula and bilateral secondary somatosensory cortex, and modulated the Neurologic Pain Signature.","[{'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Frangos', 'Affiliation': 'National Center for Complementary and Integrative Health, National Institutes of Health, Bethesda, MD, United States.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Čeko', 'Affiliation': 'National Center for Complementary and Integrative Health, National Institutes of Health, Bethesda, MD, United States.'}, {'ForeName': 'Binquan', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'National Center for Complementary and Integrative Health, National Institutes of Health, Bethesda, MD, United States.'}, {'ForeName': 'Emily A', 'Initials': 'EA', 'LastName': 'Richards', 'Affiliation': 'National Center for Complementary and Integrative Health, National Institutes of Health, Bethesda, MD, United States.'}, {'ForeName': 'John L', 'Initials': 'JL', 'LastName': 'Gracely', 'Affiliation': 'National Center for Complementary and Integrative Health, National Institutes of Health, Bethesda, MD, United States.'}, {'ForeName': 'Luana', 'Initials': 'L', 'LastName': 'Colloca', 'Affiliation': 'Department of Pain Translational Symptom Science, School of Nursing, University of Maryland, Baltimore, MA, United States.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Schweinhardt', 'Affiliation': 'The Alan Edwards Centre for Research on Pain, Neurology and Neurosurgery, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'M Catherine', 'Initials': 'MC', 'LastName': 'Bushnell', 'Affiliation': 'National Center for Complementary and Integrative Health, National Institutes of Health, Bethesda, MD, United States.'}]",Pain,['10.1097/j.pain.0000000000002064']
2712,32925971,Effectiveness of a mobile health intervention on uptake of recommended postnatal care services in Nigeria.,"Studies have linked the large percentage of maternal and neonatal mortality that occur in postnatal period to low uptake of postnatal care (PNC) services. Mobile health (mHealth) intervention through message reminders has resulted in significant increase in antenatal care utilisation in previous studies. However, its use in PNC services' uptake has not been adequately investigated in Nigeria. This study aimed to evaluate the effect of a mobile health intervention on PNC attendance among mothers in selected primary healthcare facilities in Osun State, Nigeria. A quasi-experimental research design was utilised. Participants were allocated to Intervention Group and Control Group. One hundred and ninety pregnant mothers were recruited in each group. A mobile health intervention software was developed and used to send educational and reminder messages to mothers in the intervention group from the 35th week of pregnancy to six weeks after delivery. Uptake of PNC services was assessed at birth, 3 days, 10 days and 42 days after delivery. Data were analysed using descriptive statistics, chi-square and logistic regression models. About one-third (30.9%) of respondents in the intervention group had four postnatal care visits while only 3.7% in the control group had four visits (p < 0.001). After controlling for the effect of confounding variables, group membership remained a significant predictor of PNC uptake. (AOR: 10.869, 95% CI: 4.479-26.374). Mobile health intervention significantly improved utilisation of the recommended four postnatal care visits.",2020,Mobile health (mHealth) intervention through message reminders has resulted in significant increase in antenatal care utilisation in previous studies.,"['mothers in selected primary healthcare facilities in Osun State, Nigeria', 'Nigeria', 'One hundred and ninety pregnant mothers']","['Mobile health (mHealth) intervention', 'mobile health intervention', 'Mobile health intervention', 'Intervention Group and Control Group']","['antenatal care utilisation', 'PNC uptake', 'PNC attendance', 'Uptake of PNC services', 'postnatal care visits']","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0028075', 'cui_str': 'Nigeria'}, {'cui': 'C4517622', 'cui_str': '190'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0032782', 'cui_str': 'Postpartum care'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0557854', 'cui_str': 'Services'}]",190.0,0.115177,Mobile health (mHealth) intervention through message reminders has resulted in significant increase in antenatal care utilisation in previous studies.,"[{'ForeName': 'Aanuoluwapo Omobolanle', 'Initials': 'AO', 'LastName': 'Olajubu', 'Affiliation': 'Department of Nursing Science, College of Health Sciences, Obafemi Awolowo University, Ile-Ife, Nigeria.'}, {'ForeName': 'Boluwaji Reuben', 'Initials': 'BR', 'LastName': 'Fajemilehin', 'Affiliation': 'Department of Nursing Science, College of Health Sciences, Obafemi Awolowo University, Ile-Ife, Nigeria.'}, {'ForeName': 'Temitope Oluwafemi', 'Initials': 'TO', 'LastName': 'Olajubu', 'Affiliation': 'Department of Family Medicine, Obafemi Awolowo University Teaching Hospitals Complex, Ile-Ife, Nigeria.'}, {'ForeName': 'Babajide Samuel', 'Initials': 'BS', 'LastName': 'Afolabi', 'Affiliation': 'Department of Computer Science, Obafemi Awolowo University, Ile-Ife, Nigeria.'}]",PloS one,['10.1371/journal.pone.0238911']
2713,32903044,Impact of Left Ventricular Function and Heart Failure Symptoms on Outcomes Post Ablation of Atrial Fibrillation in Heart Failure: CASTLE-AF Trial.,"BACKGROUND


Recent data demonstrate promising effects on left ventricular dysfunction and left ventricular ejection fraction (LVEF) improvement following ablation for atrial fibrillation (AF) in patients with heart failure. We sought to study the relationship between LVEF, New York Heart Association class on presentation, and the end points of mortality and heart failure admissions in the CASTLE-AF study (Catheter Ablation for Atrial Fibrillation With Heart Failure) population. Furthermore, predictors for LVEF improvement were examined.
METHODS


The CASTLE-AF patients with coexisting heart failure and AF (n=363) were randomized in a multicenter prospective controlled fashion to ablation (n=179) versus pharmacological therapy (n=184). Left ventricular function and New York Heart Association class were assessed at baseline (after randomization) and at each follow-up visit.
RESULTS


In the ablation arm, a significantly higher number of patients experienced an improvement in their LVEF to >35% at the end of the study (odds ratio, 2.17;  P <0.001). Compared with the pharmacological therapy arm, both ablation patient groups with severe (<20%) or moderate/severe (≥20% and <35%) baseline LVEF had a significantly lower number of composite end points (hazard ratio [HR], 0.60;  P =0.006), all-cause mortality (HR, 0.54;  P =0.019), and cardiovascular hospitalizations (HR, 0.66;  P =0.017). In the ablation group, New York Heart Association I/II patients at the time of treatment had the strongest improvement in clinical outcomes (primary end point: HR, 0.43;  P <0.001; mortality: HR, 0.30;  P =0.001).
CONCLUSIONS


Compared with pharmacological treatment, AF ablation was associated with a significant improvement in LVEF, independent from the severity of left ventricular dysfunction. AF ablation should be performed at early stages of the patient's heart failure symptoms.",2020,"baseline LVEF had a significantly lower number of composite endpoints (hazard ratio (HR) =0.60; p=0.006), all-cause mortality (HR=0.54; p=0.019) and cardiovascular (CV) hospitalizations (HR=0.66; p=0.017).","['patients with heart failure (HF', 'Heart Failure', 'AF patients with coexisting HF and AF (n=363']","['pharmacological therapy', 'AF ablation']","['cause mortality', 'LVEF', 'cardiovascular (CV) hospitalizations', 'number of composite endpoints', 'LV function and NYHA class', 'mortality and HF admissions', 'left ventricular (LV) dysfunction and LV ejection fraction (EF) improvement']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]","[{'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1275491', 'cui_str': 'New York Heart Association Classification'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0242698', 'cui_str': 'Impaired left ventricular function'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}]",363.0,0.0339413,"baseline LVEF had a significantly lower number of composite endpoints (hazard ratio (HR) =0.60; p=0.006), all-cause mortality (HR=0.54; p=0.019) and cardiovascular (CV) hospitalizations (HR=0.66; p=0.017).","[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Sohns', 'Affiliation': 'Clinic for Electrophysiology, Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum, Bad Oeynhausen, Germany (C.S.).'}, {'ForeName': 'Konstantin', 'Initials': 'K', 'LastName': 'Zintl', 'Affiliation': 'Department of Cardiology, Klinikum Coburg, Germany (K.Z., C.M., J.B.).'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Department of Cardiology, Tulane University School of Medicine, New Orleans, LA (Y.Z., L.D., N.F.M.).'}, {'ForeName': 'Lilas', 'Initials': 'L', 'LastName': 'Dagher', 'Affiliation': 'Department of Cardiology, Tulane University School of Medicine, New Orleans, LA (Y.Z., L.D., N.F.M.).'}, {'ForeName': 'Dietrich', 'Initials': 'D', 'LastName': 'Andresen', 'Affiliation': 'Kardiologie an den Ev. Elisabeth-Kliniken, Berlin, Germany (D.A.).'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Siebels', 'Affiliation': 'Electrophysiology Center Bremen, Germany (J.S.).'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Wegscheider', 'Affiliation': 'Department of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Germany (K.W., S.S.).'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Sehner', 'Affiliation': 'Department of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Germany (K.W., S.S.).'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Boersma', 'Affiliation': 'Department of Cardiology, Antonius Ziekenhuis Nieuwegein, the Netherlands (L.B.).'}, {'ForeName': 'Béla', 'Initials': 'B', 'LastName': 'Merkely', 'Affiliation': 'Department of Cardiology, Semmelweis Medical University, Budapest, Hungary (B.M.).'}, {'ForeName': 'Evgeny', 'Initials': 'E', 'LastName': 'Pokushalov', 'Affiliation': 'State Research Institute of Circulation Pathology, Novosibirsk, Russia (E.P.).'}, {'ForeName': 'Prashanthan', 'Initials': 'P', 'LastName': 'Sanders', 'Affiliation': 'Center for Heart Rhythm Disorders, University of Adelaide and Royal Adelaide Hospital, Australia (P.S.).'}, {'ForeName': 'Heribert', 'Initials': 'H', 'LastName': 'Schunkert', 'Affiliation': 'Department of Cardiology, Deutsches Herzzentrum München, Munich, Germany (H.S.).'}, {'ForeName': 'Dietmar', 'Initials': 'D', 'LastName': 'Bänsch', 'Affiliation': 'Clinic for Electrophysiology, KMG Klinikum, Güstrow, Germany (D.B.).'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Mahnkopf', 'Affiliation': 'Department of Cardiology, Klinikum Coburg, Germany (K.Z., C.M., J.B.).'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Brachmann', 'Affiliation': 'Department of Cardiology, Klinikum Coburg, Germany (K.Z., C.M., J.B.).'}, {'ForeName': 'Nassir F', 'Initials': 'NF', 'LastName': 'Marrouche', 'Affiliation': 'Department of Cardiology, Tulane University School of Medicine, New Orleans, LA (Y.Z., L.D., N.F.M.).'}]",Circulation. Arrhythmia and electrophysiology,['10.1161/CIRCEP.120.008461']
2714,32903263,"Mental fatigue impairs physical activity, technical and decision-making performance during small-sided games.","The aim of this study was to investigate the effects of mental fatigue on physical activity, technical and decision-making performance during small-sided games. Nine sub-elite soccer players were enrolled in the study. The players performed two small-sided games on two occasions within a crossover experimental design. Before each game, they underwent a mental fatiguing task (Stroop task) and a control task (documentary watching) in a randomized, counterbalanced order. Players' physical activity, technical, and decision-making performance were obtained during small-sided games by GPS and video scouting. Results showed that distance in acceleration covered per min, negative passes, passing accuracy, and shot accuracy were likely impaired than control task after a mental fatiguing protocol. Decision-making performance of negative passes, passes accuracy, and dribbling accuracy resulted also likely decreased compared with control task. These findings demonstrated that mental fatigue impacted on technical, GPS-derived, and soccer-specific decision-making performance during SSG. In conclusion, avoiding cognitively demanding tasks before playing soccer-specific activities may be advisable to preserve players' physical activity, technical, and decision-making skills.",2020,"Decision-making performance of negative passes, passes accuracy, and dribbling accuracy resulted also likely decreased compared with control task.",['Nine sub-elite soccer players'],['mental fatiguing task (Stroop task) and a control task (documentary watching'],"[""Players' physical activity, technical, and decision-making performance"", 'distance in acceleration covered per min, negative passes, passing accuracy, and shot accuracy', 'Mental fatigue impairs physical activity, technical and decision-making performance', 'physical activity, technical and decision-making performance']","[{'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}]","[{'cui': 'C0015676', 'cui_str': 'Mental fatigue'}, {'cui': 'C2718024', 'cui_str': 'Stroop Task'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0000894', 'cui_str': 'Acceleration'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0015676', 'cui_str': 'Mental fatigue'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}]",,0.0335694,"Decision-making performance of negative passes, passes accuracy, and dribbling accuracy resulted also likely decreased compared with control task.","[{'ForeName': 'Athos', 'Initials': 'A', 'LastName': 'Trecroci', 'Affiliation': 'Department of Biomedical Sciences for Health, Università degli Studi di Milano, Milano, Italy.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Boccolini', 'Affiliation': 'Department of Biomedical Sciences for Health, Università degli Studi di Milano, Milano, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Duca', 'Affiliation': 'Department of Biomedical Sciences for Health, Università degli Studi di Milano, Milano, Italy.'}, {'ForeName': 'Damiano', 'Initials': 'D', 'LastName': 'Formenti', 'Affiliation': 'Department of Biotechnology and Life Sciences (DBSV), University of Insubria, Varese, Italy.'}, {'ForeName': 'Giampietro', 'Initials': 'G', 'LastName': 'Alberti', 'Affiliation': 'Department of Biomedical Sciences for Health, Università degli Studi di Milano, Milano, Italy.'}]",PloS one,['10.1371/journal.pone.0238461']
2715,32903275,The potential effect of instrumentation with different nickel titanium rotary systems on dentinal crack formation-An in vitro study.,"The potential mechanical impact of different rotary systems used for root canal preparation has been a matter of debate for long. The aim of this study was to explore the incidence of dentinal cracks after root canal instrumentation with various rotary systems, in vitro. One hundred and eighty intact lower central incisors were selected and randomly divided into fourteen treatment groups (n = 12/group) and a control group (n = 12). After decoronation, the root canals were instrumented with fourteen different rotary systems (E3, E3 azure, NT2, Hyflex CM, Hyflex EDM, 2Shape, OneCurve, ProTaper Next, ProTaper Gold, WaveOne Gold, Mtwo, Reciproc Blue, TF adaptive, K3XF). All roots were horizontally sectioned at 3, 6, and 9 mm from the apex with a low-speed saw under water-cooling. The slices were then examined under stereomicroscope for dentinal cracks. No cracks were found in the control group. Cracks were found in all treatment groups, predominantly in the 3 mm slices. There was no statistically significant difference in the number of cracks when comparing the different systems to each other at any section level. At 3 mm, however, five of the studied systems, namely K3XF (p = 0.004), Protaper Next (p = 0.001), Reciproc Blue (p<0.001), TF adaptive (p = 0.050), and 2Shape (p = 0.009) presented a significantly higher number of cracks than the control group. Within the limitations of this study, instrumented canals presented dentinal cracks, while uninstrumented ones presented no cracks after sectioning. There seems to be no significant difference among the tested systems regarding crack formation in the instrumented root canal wall. Crack formation occurred irrespective of the motion of the rotary system (rotational or reciprocation). Further studies are needed to clarify the factors that contribute to crack formation in the case of each individual rotary system.",2020,There was no statistically significant difference in the number of cracks when comparing the different systems to each other at any section level.,['One hundred and eighty intact lower central incisors'],['nickel titanium rotary systems'],"['Reciproc Blue (p<0.001), TF adaptive', 'number of cracks', 'Crack formation', 'incidence of dentinal cracks']","[{'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0021156', 'cui_str': 'Structure of incisor tooth'}]","[{'cui': 'C0068790', 'cui_str': 'nitinol'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C1260957', 'cui_str': 'Blue color'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0040441', 'cui_str': 'Fracture of tooth'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",180.0,0.0185325,There was no statistically significant difference in the number of cracks when comparing the different systems to each other at any section level.,"[{'ForeName': 'Márk', 'Initials': 'M', 'LastName': 'Fráter', 'Affiliation': 'Department of Operative and Esthetic Dentistry, Faculty of Dentistry, University of Szeged, Szeged, Hungary.'}, {'ForeName': 'András', 'Initials': 'A', 'LastName': 'Jakab', 'Affiliation': 'Department of Operative and Esthetic Dentistry, Faculty of Dentistry, University of Szeged, Szeged, Hungary.'}, {'ForeName': 'Gábor', 'Initials': 'G', 'LastName': 'Braunitzer', 'Affiliation': 'dicomLAB Dental Ltd., Szeged, Hungary.'}, {'ForeName': 'Zsolt', 'Initials': 'Z', 'LastName': 'Tóth', 'Affiliation': 'Department of Oral Biology and Experimental Dental Research, Faculty of Dentistry, University of Szeged, Szeged, Hungary.'}, {'ForeName': 'Katalin', 'Initials': 'K', 'LastName': 'Nagy', 'Affiliation': 'Department of Oral Surgery, Faculty of Dentistry, University of Szeged, Szeged, Hungary.'}]",PloS one,['10.1371/journal.pone.0238790']
2716,32915900,Impact of electrolyte-rich dialysate during continuous renal replacement therapy on serum phosphate and potassium in ICU patients.,"BACKGROUND


Hypophosphatemia and hypokalemia occur frequently during continuous renal replacement therapy (CRRT). We evaluated serum phosphate and potassium levels in patients administered three different types of dialysis solution.
METHODS


The study population consisted of 324 intensive care unit patients who underwent CRRT between January 2015 and December 2018. Patients were divided into three groups: group 1 (n = 105) received Hemosol B0 (no potassium or phosphate); group 2 (n = 78) received Hemosol B0 and potassium-containing solution (MultiBic); and group 3 (n = 141) received phosphate- and potassium-containing solution (Phoxilium), Hemosol B2, Prismasol 2, and Prismasol 4. A different protocol was followed in each group.
RESULTS


The incidence rate of hypophosphatemia was 55% lower in group 3 compared to group 1 (incidence rate ratio (IRR) 0.45, 95% confidence interval (CI): 0.33 to 0.61) and 61% lower compared to group 2 (IRR 0.39, 95% CI: 0.29 to 0.53). Group 3 also had a 50% lower incidence rate of hypokalemia compared to group 1 (IRR 0.50, 95% CI: 0.29 to 0.88). The negative slope in phosphate level in group 3 was greater than that in group 1 (ß = 0.19, 95% CI: 0.02 to 0.37, p = 0.032), while the negative slope in the potassium level was greater in group 2 than in group 1(ß = 0.10, 95% CI: 0.03 to 0.17, p = 0.008). Additional intravenous calcium was not used in any case, and most cases of acid-base disturbances were well controlled.
CONCLUSIONS


The use of phosphate- and potassium-containing with a proper CRRT protocol prevented decreases in serum phosphate and potassium levels, thus also preventing hypophosphatemia and hypokalemia, and additional replacement during CRRT.",2020,"The negative slope in phosphate level in group 3 was greater than that in group 1 (ß = 0.19, 95% CI: 0.02 to 0.37, p = 0.032), while the negative slope in the potassium level was greater in group 2 than in group 1(ß = 0.10, 95% CI: 0.03 to 0.17, p = 0.008).","['patients administered three different types of dialysis solution', 'ICU patients', '324 intensive care unit patients who underwent CRRT between January 2015 and December 2018']","['electrolyte-rich dialysate', 'Hemosol B0 and potassium-containing solution (MultiBic', 'Hemosol B0 (no potassium or phosphate', 'continuous renal replacement therapy (CRRT', 'Additional intravenous calcium', 'phosphate- and potassium-containing with a proper CRRT protocol', 'phosphate- and potassium-containing solution (Phoxilium), Hemosol B2, Prismasol 2, and Prismasol 4']","['incidence rate of hypophosphatemia', 'negative slope in the potassium level', 'incidence rate of hypokalemia', 'serum phosphate and potassium levels', 'negative slope in phosphate level', 'hypophosphatemia and hypokalemia', 'serum phosphate and potassium']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011947', 'cui_str': 'Dialysis fluid'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C4517713', 'cui_str': '324'}, {'cui': 'C0010337', 'cui_str': 'Care of intensive care unit patient'}, {'cui': 'C3649547', 'cui_str': 'Continuous renal replacement therapy'}]","[{'cui': 'C0013832', 'cui_str': 'electrolytes'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0011947', 'cui_str': 'Dialysis fluid'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C3649547', 'cui_str': 'Continuous renal replacement therapy'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0085682', 'cui_str': 'Hypophosphatemia'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0202194', 'cui_str': 'Potassium measurement'}, {'cui': 'C0020621', 'cui_str': 'Hypokalemia'}, {'cui': 'C0036820', 'cui_str': 'Serum phosphate'}, {'cui': 'C0523826', 'cui_str': 'Phosphate measurement'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}]",,0.0800356,"The negative slope in phosphate level in group 3 was greater than that in group 1 (ß = 0.19, 95% CI: 0.02 to 0.37, p = 0.032), while the negative slope in the potassium level was greater in group 2 than in group 1(ß = 0.10, 95% CI: 0.03 to 0.17, p = 0.008).","[{'ForeName': 'AJin', 'Initials': 'A', 'LastName': 'Cho', 'Affiliation': 'Department of Internal Medicine, Kangnam Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Young-Ki', 'Initials': 'YK', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Kangnam Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Hayne Cho', 'Initials': 'HC', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Kangnam Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Republic of Korea.'}]",PloS one,['10.1371/journal.pone.0238867']
2717,32916855,The Potential Influence of Group Membership on Outcomes in Indicated Cognitive-Behavioral Adolescent Depression Prevention.,"BACKGROUND


Adolescent depression prevention programs are typically delivered in groups in which adolescents share a common setting and interventionist, but the influence of the group is usually ignored or statistically controlled. We tested whether the primary outcomes of reductions in depressive symptoms and future onset of major depressive disorder (MDD) varied as a function of group membership.
METHODS


Data were available from two randomized trials in which 220 adolescents received the Blues Program indicated prevention intervention in 36 separate groups; participants were assessed at baseline, post intervention, and at 6-, 12-, and 24-month follow-ups.
RESULTS


Ten percent of participants had developed MDD 2 years post intervention. Group-level effects for MDD onset over follow-up were nonsignificant (accounted for <1% of variance; ICC = 0.004, ns). Group-level effects for depressive symptom change across the follow-up period were also nonsignificant (ICC = 0.001, ns) but group effects accounted for 16% of depressive symptom change immediately post intervention (ICC = 0.159,  p  < 0.05). Group-level clustering of posttest depressive symptoms was not associated with size of group or gender composition.
CONCLUSIONS


Membership in specific adolescent cognitive-behavioral depression prevention groups may have an impact in terms of immediate symptom reduction but does not appear to have significant prevention effects in terms of long-term symptom change or MDD onset.",2020,"Group-level effects for depressive symptom change across the follow-up period were also nonsignificant (ICC = 0.001, ns) but group effects accounted for 16% of depressive symptom change immediately post intervention (ICC = 0.159,  p  < 0.05).",['Data were available from two randomized trials in which 220 adolescents received the'],"['Blues Program indicated prevention intervention', 'Group Membership']","['depressive symptoms and future onset of major depressive disorder (MDD', 'depressive symptom change']","[{'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C1260957', 'cui_str': 'Blue color'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",220.0,0.127502,"Group-level effects for depressive symptom change across the follow-up period were also nonsignificant (ICC = 0.001, ns) but group effects accounted for 16% of depressive symptom change immediately post intervention (ICC = 0.159,  p  < 0.05).","[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Rohde', 'Affiliation': 'Oregon Research Institute, Eugene, OR 97403, USA.'}, {'ForeName': 'Frédéric N', 'Initials': 'FN', 'LastName': 'Brière', 'Affiliation': 'École de Psychoéducation, Université de Montréal, Montreal, QC H3T 1J4, Canada.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Stice', 'Affiliation': 'Psychiatry and Behavioral Sciences (Public Mental Health and Population Sciences), Stanford University Medical Center, Stanford, CA 94305, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph17186553']
2718,32918853,Mediterranean Diet and Atherothrombosis Biomarkers: A Randomized Controlled Trial.,"SCOPE


To assess whether following a Mediterranean diet (MedDiet) improves atherothrombosis biomarkers in high cardiovascular risk individuals.
METHODS AND RESULTS


In 358 random volunteers from the PREvención con DIeta MEDiterránea trial, the 1-year effects on atherothrombosis markers of an intervention with MedDiet, enriched with virgin olive oil (MedDiet-VOO; n = 120) or nuts (MedDiet-Nuts; n = 119) versus a low-fat control diet (n = 119), and whether large increments in MedDiet adherence (≥3 score points, versus compliance decreases) and intake changes in key food items are associated with 1-year differences in biomarkers. Differences are observed between 1-year changes in the MedDiet-VOO intervention and control diet on the activity of platelet activating factor acetylhydrolase in high-density lipoproteins (HDLs) (+7.5% [95% confidence interval: 0.17; 14.8]) and HDL-bound α 1  -antitrypsin levels (-6.1% [-11.8; -0.29]), and between the MedDiet-Nuts intervention and the control arm on non-esterified fatty acid concentrations (-9.3% [-18.1; -0.53]). Large MedDiet adherence increments are associated with less fibrinogen (-9.5% [-18.3; -0.60]) and non-esterified fatty acid concentrations (-16.7% [-31.7; -1.74]). Increases in nut, fruit, vegetable, and fatty fish consumption, and decreases in processed meat intake are linked to enhancements in biomarkers.
CONCLUSION


MedDiet improves atherothrombosis biomarkers in high cardiovascular risk individuals.",2020,Large MedDiet adherence increments were associated with less fibrinogen (-9.5% [-18.3; -0.60]) and non-esterified fatty acid concentrations (-16.7% [-31.7;,"['358 random volunteers from the PREvención con DIeta MEDiterránea trial', 'high cardiovascular risk individuals', 'Mediterranean Diet and Atherothrombosis Biomarkers']","['virgin olive oil (MedDiet-VOO; n = 120) or nuts (MedDiet-Nuts; n = 119) versus a low-fat control diet', 'Mediterranean diet (MedDiet']","['HDL-bound α 1  -antitrypsin levels', 'nut, fruit, vegetable, and fatty fish consumption', 'non-esterified fatty acid concentrations', 'atherothrombosis biomarkers', 'MedDiet adherence']","[{'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C1963943', 'cui_str': 'Atherothrombosis'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]","[{'cui': 'C0555061', 'cui_str': 'Virgin'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0028723', 'cui_str': 'Nut'}, {'cui': 'C0242970', 'cui_str': 'Low fat diet'}, {'cui': 'C0743195', 'cui_str': 'Dietary control'}]","[{'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0332297', 'cui_str': 'Bounded by'}, {'cui': 'C2713669', 'cui_str': 'SERPINA5 protein, human'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0028723', 'cui_str': 'Nut'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0453017', 'cui_str': 'Fatty fish'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0369212', 'cui_str': 'Esterified fatty acid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1963943', 'cui_str': 'Atherothrombosis'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",358.0,0.0899458,Large MedDiet adherence increments were associated with less fibrinogen (-9.5% [-18.3; -0.60]) and non-esterified fatty acid concentrations (-16.7% [-31.7;,"[{'ForeName': 'Álvaro', 'Initials': 'Á', 'LastName': 'Hernáez', 'Affiliation': 'Cardiovascular Risk, Nutrition and Aging Research Unit, August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Barcelona, 08003, Spain.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Castañer', 'Affiliation': 'CIBER of Pathophysiology of Obesity and Nutrition (CIBEROBN), Instituto de Salud Carlos III, Madrid, 28029, Spain.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Tresserra-Rimbau', 'Affiliation': 'CIBER of Pathophysiology of Obesity and Nutrition (CIBEROBN), Instituto de Salud Carlos III, Madrid, 28029, Spain.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Pintó', 'Affiliation': 'CIBER of Pathophysiology of Obesity and Nutrition (CIBEROBN), Instituto de Salud Carlos III, Madrid, 28029, Spain.'}, {'ForeName': 'Montserrat', 'Initials': 'M', 'LastName': 'Fitó', 'Affiliation': 'CIBER of Pathophysiology of Obesity and Nutrition (CIBEROBN), Instituto de Salud Carlos III, Madrid, 28029, Spain.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Casas', 'Affiliation': 'Cardiovascular Risk, Nutrition and Aging Research Unit, August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Barcelona, 08003, Spain.'}, {'ForeName': 'Miguel Ángel', 'Initials': 'MÁ', 'LastName': 'Martínez-González', 'Affiliation': 'CIBER of Pathophysiology of Obesity and Nutrition (CIBEROBN), Instituto de Salud Carlos III, Madrid, 28029, Spain.'}, {'ForeName': 'Dolores', 'Initials': 'D', 'LastName': 'Corella', 'Affiliation': 'CIBER of Pathophysiology of Obesity and Nutrition (CIBEROBN), Instituto de Salud Carlos III, Madrid, 28029, Spain.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Salas-Salvadó', 'Affiliation': 'CIBER of Pathophysiology of Obesity and Nutrition (CIBEROBN), Instituto de Salud Carlos III, Madrid, 28029, Spain.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Lapetra', 'Affiliation': 'CIBER of Pathophysiology of Obesity and Nutrition (CIBEROBN), Instituto de Salud Carlos III, Madrid, 28029, Spain.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Gómez-Gracia', 'Affiliation': 'CIBER of Pathophysiology of Obesity and Nutrition (CIBEROBN), Instituto de Salud Carlos III, Madrid, 28029, Spain.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Arós', 'Affiliation': 'CIBER of Pathophysiology of Obesity and Nutrition (CIBEROBN), Instituto de Salud Carlos III, Madrid, 28029, Spain.'}, {'ForeName': 'Miquel', 'Initials': 'M', 'LastName': 'Fiol', 'Affiliation': 'CIBER of Pathophysiology of Obesity and Nutrition (CIBEROBN), Instituto de Salud Carlos III, Madrid, 28029, Spain.'}, {'ForeName': 'Lluis', 'Initials': 'L', 'LastName': 'Serra-Majem', 'Affiliation': 'CIBER of Pathophysiology of Obesity and Nutrition (CIBEROBN), Instituto de Salud Carlos III, Madrid, 28029, Spain.'}, {'ForeName': 'Emilio', 'Initials': 'E', 'LastName': 'Ros', 'Affiliation': 'Cardiovascular Risk, Nutrition and Aging Research Unit, August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Barcelona, 08003, Spain.'}, {'ForeName': 'Ramón', 'Initials': 'R', 'LastName': 'Estruch', 'Affiliation': 'Cardiovascular Risk, Nutrition and Aging Research Unit, August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Barcelona, 08003, Spain.'}]",Molecular nutrition & food research,['10.1002/mnfr.202000350']
2719,32919098,Evaluation of a personally-tailored opioid overdose prevention education and naloxone distribution intervention to promote harm reduction and treatment readiness in individuals actively using illicit opioids.,"BACKGROUND


Opioid overdose prevention education and naloxone distribution (OEND) programs include information on general risk factors, overdose recognition, and naloxone utilization. This study evaluated a personally-tailored OEND (PTOEND) intervention designed to promote harm reduction and treatment readiness for illicit opioid users by also including education about personal overdose-risk factors and medication for opioid use disorder (MOUD).
METHOD


A secondary analysis of a randomized controlled trial testing a Peer recovery support service (PRSS) intervention, relative to Control, in adult illicit opioid users reporting treatment for an overdose in the prior 6 months. PTOEND, a 30-minute computer-guided intervention, was administered by a research assistant at the randomization visit to all participants (N = 80). Participants completed a telephone visit 3 weeks post-randomization (n = 74) to assess changes in opioid overdose/MOUD knowledge and treatment readiness. Participants completed in-person visits at 3 (n = 66), 6 (n = 58), and 12 (n = 44) months post-randomization to assess illicit opioid use and naloxone utilization (all time points) and overdose-risk behaviors (12 months). We conducted pre-post analyses of the impact of PTOEND controlling for the PRSS effect.
RESULTS


PTOEND increased knowledge of overdose (79.8% to 81.5%, p < 0.05) and MOUD (66.9% to 75.0%, p < 0.01) and decreased perceived treatment barriers (2.1 to 1.9, p < 0.01); desire to quit all substances increased (7.2 to 7.8, p = 0.05). Self-reported opioid use was significantly decreased at each follow-up (all p < 0.01). Self-reported overdose-risk behaviors decreased significantly (6.2 to 2.4, p < 0.01). A majority of participants (65 %) reported naloxone utilization.
CONCLUSIONS


PTOEND may be effective for promoting harm reduction and treatment readiness.",2020,"RESULTS


PTOEND increased knowledge of overdose (79.8% to 81.5%, p < 0.05) and MOUD (66.9% to 75.0%, p < 0.01) and decreased perceived treatment barriers (2.1 to 1.9, p < 0.01); desire to quit all substances increased (7.2 to 7.8, p = 0.05).","['adult illicit opioid users reporting treatment for an overdose in the prior 6 months', 'individuals actively using illicit opioids']","['naloxone distribution intervention', 'Peer recovery support service (PRSS) intervention']","['Self-reported overdose-risk behaviors', 'Self-reported opioid use', 'knowledge of overdose', 'illicit opioid use and naloxone utilization (all time points) and overdose-risk behaviors', 'desire to quit all substances', 'MOUD']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332266', 'cui_str': 'Illicit'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0029944', 'cui_str': 'Drug overdose'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0027358', 'cui_str': 'Naloxone'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0029944', 'cui_str': 'Drug overdose'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0332266', 'cui_str': 'Illicit'}, {'cui': 'C0027358', 'cui_str': 'Naloxone'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}]",80.0,0.027065,"RESULTS


PTOEND increased knowledge of overdose (79.8% to 81.5%, p < 0.05) and MOUD (66.9% to 75.0%, p < 0.01) and decreased perceived treatment barriers (2.1 to 1.9, p < 0.01); desire to quit all substances increased (7.2 to 7.8, p = 0.05).","[{'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Winhusen', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3230 Eden Ave, Cincinnati, OH 45267, USA. Electronic address: winhusen@carc.uc.edu.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Wilder', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3230 Eden Ave, Cincinnati, OH 45267, USA.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Lyons', 'Affiliation': 'Department of Emergency Medicine, University of Cincinnati College of Medicine 231, Albert Sabin Way, Cincinnati, OH 45267, USA.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Theobald', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3230 Eden Ave, Cincinnati, OH 45267, USA.'}, {'ForeName': 'Frankie', 'Initials': 'F', 'LastName': 'Kropp', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3230 Eden Ave, Cincinnati, OH 45267, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Lewis', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3230 Eden Ave, Cincinnati, OH 45267, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108265']
2720,32919196,Understanding the composite dimensions of the EQ-5D: An experimental approach.,"The EQ-5D(-5L) includes two composite dimensions: ""Pain or Discomfort"" (P/D) and ""Anxiety or Depression"" (A/D), which involves an inherent ambiguity. Little is known about how these composite dimensions are interpreted across contexts where (i) individuals self-report their own health; and (ii) individuals value stylised health states. We detail the nature of the ambiguity and present experimental evidence from two large online surveys (n = 1007 and n = 1415). In one survey, individuals reported both their current health and their health at the time they felt the worst because of their health. In the other, they valued stylised EQ-5D states using Discrete Choice Experiments with duration as an attribute. In both surveys, participants were randomised into treatments in which the presentation of one of the composite dimensions was altered, or a control. Our results suggest (1) In self-report, use of the composite dimensions differs across the dimensions, with P/D used mainly to report Pain, but A/D used mainly to mean the more severe component of Anxiety and Depression. (2) In valuation, Pain was perceived to be worse than Discomfort at the same level, and Depression was perceived to be worse than Anxiety at the same level. (3) In valuation, the composite dimension P/D was interpreted to mean Pain, whilst the composite dimension A/D was interpreted to lie between Anxiety and Depression. We conclude that care must be taken when interpreting responses to existing health (or wellbeing) descriptive systems that rely on composite dimensions, and that caution should be applied when designing new ones.",2020,"In valuation, Pain was perceived to be worse than Discomfort at the same level, and Depression was perceived to be worse than Anxiety at the same level.",[],['EQ-5D'],"['Pain or Discomfort"" (P/D) and ""Anxiety or Depression"" (A/D', 'severe component of Anxiety and Depression']",[],[],"[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0449432', 'cui_str': 'Component'}]",,0.0204719,"In valuation, Pain was perceived to be worse than Discomfort at the same level, and Depression was perceived to be worse than Anxiety at the same level.","[{'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'McDonald', 'Affiliation': 'University of Birmingham, UK. Electronic address: r.l.mcdonald@bham.ac.uk.'}, {'ForeName': 'Timothy L', 'Initials': 'TL', 'LastName': 'Mullett', 'Affiliation': 'University of Warwick, UK.'}, {'ForeName': 'Aki', 'Initials': 'A', 'LastName': 'Tsuchiya', 'Affiliation': 'University of Sheffield, UK.'}]",Social science & medicine (1982),['10.1016/j.socscimed.2020.113323']
2721,32919280,No benefit of HDL mimetic CER-001 on carotid atherosclerosis in patients with genetically determined very low HDL levels.,"BACKGROUND AND AIMS


Infusion of high-density lipoprotein (HDL) mimetics failed to induce regression of atherosclerosis in recent randomized clinical trials. However, patients in these previous trials had normal levels of HDL-cholesterol, which potentially limited efficacy. Patients with very low levels of HDL-cholesterol and impaired cholesterol efflux capacity can be expected to derive the most potential benefit from infusion of HDL mimetics. This randomized clinical trial evaluated the efficacy of infusions of the HDL mimetic CER-001 in patients with genetically determined very low levels of HDL cholesterol.
METHODS


In this multicenter, randomized clinical trial, we recruited patients with familial hypoalphalipoproteinemia (due to ABCA1 and/or APOA1 loss-of-function variants). Participants were randomized to intravenous infusions of 8 mg/kg CER-001 or placebo (2:1 ratio), comprising 9 weekly infusions followed by infusions every two weeks. Patients underwent repeated 3T-MRI to assess mean vessel wall area and  18 F-FDG PET/CT to quantify arterial wall inflammation.
RESULTS


A total of 30 patients with a mean age of 52.7 ± 7.4 years and HDL-cholesterol of 0.35 ± 0.25 mmol/L were recruited. After 24 weeks, the absolute change in mean vessel wall area was not significantly different in the CER-001 group compared with placebo (n = 27; treatment difference: 0.77 mm 2 , p = 0.21). Furthermore, there was no significant difference in carotid arterial wall inflammation (n = 24, treatment difference: 0.10 target-to-background ratio of the most diseased segment, p = 0.33) after 24 weeks.
CONCLUSION


In patients with genetically determined very low HDL-cholesterol, 24 weeks of treatment with HDL mimetic CER-001 did not reduce carotid vessel wall dimensions or arterial wall inflammation, compared with placebo.",2020,"After 24 weeks, the absolute change in mean vessel wall area was not significantly different in the CER-001 group compared with placebo (n = 27; treatment difference: 0.77 mm 2 , p = 0.21).","['patients with genetically determined very low HDL levels', 'patients with genetically determined very low levels of HDL cholesterol', '30 patients with a mean age of 52.7\xa0±\xa07.4 years and HDL-cholesterol of 0.35\xa0±\xa00.25\xa0mmol/L were recruited', 'patients with genetically determined very low HDL-cholesterol, 24 weeks of treatment with', 'patients with familial hypoalphalipoproteinemia (due to ABCA1 and/or APOA1 loss-of-function variants']","['placebo', 'HDL mimetic CER-001', 'intravenous infusions of 8\xa0mg/kg CER-001 or placebo', 'repeated 3T-MRI']","['carotid arterial wall inflammation', 'absolute change in mean vessel wall area', 'normal levels of HDL-cholesterol', 'carotid atherosclerosis', 'carotid vessel wall dimensions or arterial wall inflammation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0442811', 'cui_str': 'Very low'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517858', 'cui_str': '7.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517451', 'cui_str': '0.35'}, {'cui': 'C4517443', 'cui_str': '0.25'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1704429', 'cui_str': 'Familial hypoalphalipoproteinemia'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C3711161', 'cui_str': 'ABCA1 protein, human'}, {'cui': 'C1677784', 'cui_str': 'APOA1 protein, human'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205419', 'cui_str': 'Variant'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C3884609', 'cui_str': 'CER-001'}, {'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C1097281', 'cui_str': '3-(3,4-dimethoxyphenyl)-1H-1,2,4-triazole'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0507850', 'cui_str': 'Wall of artery'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0205380', 'cui_str': 'Walled'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0577631', 'cui_str': 'Carotid atherosclerosis'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}]",30.0,0.409435,"After 24 weeks, the absolute change in mean vessel wall area was not significantly different in the CER-001 group compared with placebo (n = 27; treatment difference: 0.77 mm 2 , p = 0.21).","[{'ForeName': 'Kang H', 'Initials': 'KH', 'LastName': 'Zheng', 'Affiliation': 'Department of Vascular Medicine, Amsterdam University Medical Centers, Amsterdam, the Netherlands.'}, {'ForeName': 'Yannick', 'Initials': 'Y', 'LastName': 'Kaiser', 'Affiliation': 'Department of Vascular Medicine, Amsterdam University Medical Centers, Amsterdam, the Netherlands.'}, {'ForeName': 'Casper C', 'Initials': 'CC', 'LastName': 'van Olden', 'Affiliation': 'Department of Vascular Medicine, Amsterdam University Medical Centers, Amsterdam, the Netherlands.'}, {'ForeName': 'Raul D', 'Initials': 'RD', 'LastName': 'Santos', 'Affiliation': 'Lipid Clinic Heart Institute (InCor), University of Sao Paulo Medical School Hospital, Sao Paulo, Brazil; Hospital Israelita Albert Einstein, Sao Paulo, Brazil.'}, {'ForeName': 'Jean-Louis', 'Initials': 'JL', 'LastName': 'Dasseux', 'Affiliation': 'Cerenis Therapeutics, Labège, Toulouse, France.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Genest', 'Affiliation': 'Department of Medicine, Division of Cardiology, McGill University, Montréal, Quebec, Canada.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Gaudet', 'Affiliation': 'Department of Medicine, Université de Montréal, Chicoutimi, Quebec, Canada.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Westerink', 'Affiliation': 'Department of Vascular Medicine, Utrecht University Medical Center, Utrecht, the Netherlands.'}, {'ForeName': 'Constance', 'Initials': 'C', 'LastName': 'Keyserling', 'Affiliation': 'Cerenis Therapeutics, Labège, Toulouse, France.'}, {'ForeName': 'Hein J', 'Initials': 'HJ', 'LastName': 'Verberne', 'Affiliation': 'Department of Vascular Medicine, Amsterdam University Medical Centers, Amsterdam, the Netherlands.'}, {'ForeName': 'Eran', 'Initials': 'E', 'LastName': 'Leitersdorf', 'Affiliation': 'Center for Research, Prevention and Treatment of Atherosclerosis, Hadassah Hebrew University Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Hegele', 'Affiliation': 'Robarts Research Institute, Western University, London, Ontario, Canada.'}, {'ForeName': 'Olivier S', 'Initials': 'OS', 'LastName': 'Descamps', 'Affiliation': 'Centres Hospitaliers Jolimont, La Louvière, Belgium.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Hopkins', 'Affiliation': 'University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Aart J', 'Initials': 'AJ', 'LastName': 'Nederveen', 'Affiliation': 'Department of Vascular Medicine, Amsterdam University Medical Centers, Amsterdam, the Netherlands.'}, {'ForeName': 'Erik S G', 'Initials': 'ESG', 'LastName': 'Stroes', 'Affiliation': 'Department of Vascular Medicine, Amsterdam University Medical Centers, Amsterdam, the Netherlands. Electronic address: e.s.stroes@amsterdamumc.nl.'}]",Atherosclerosis,['10.1016/j.atherosclerosis.2020.08.004']
2722,32920941,Pragmatic multicentre factorial randomized controlled trial testing measures to reduce surgical site infection in low- and middle-income countries: study protocol of the FALCON trial.,"AIM


Surgical site infection (SSI) is the commonest postoperative complication worldwide, representing a major burden for patients and health systems. Rates of SSI are significantly higher in low- and middle-income countries (LMICs) but there is little high-quality evidence on interventions to prevent SSI in LMICs.
METHOD


FALCON is a pragmatic, multicentre, 2 x 2 factorial, stratified randomized controlled trial, with an internal feasibility study, which will address the need for evidence on measures to reduce rates of SSI in patients in LMICs undergoing abdominal surgery. To assess whether either (1) 2% alcoholic chlorhexidine versus 10% povidone-iodine for skin preparation, or (2) triclosan-coated suture versus non-coated suture for fascial closure, can reduce surgical site infection at 30-days post-surgery for each of (1) clean-contaminated and (2) contaminated/dirty surgery. Patients with predicted clean-contaminated or contaminated/dirty wounds with abdominal skin incision ≥ 5 cm will be randomized 1:1:1:1 between (1) 2% alcoholic chlorhexidine and noncoated suture, (2) 2% alcoholic chlorhexidine and triclosan-coated suture, (3) 10% aqueous povidone-iodine and noncoated suture and (4) 10% aqueous povidone-iodine and triclosan-coated suture. The two strata (clean-contaminated versus contaminated/dirty wounds) are separately powered. Overall, FALCON aims to recruit 5480 patients. The primary outcome is SSI at 30 days, based on the Centers for Disease Control definition of SSI.
CONCLUSION


FALCON will deliver high-quality evidence that is generalizable across a range of LMIC settings. It will influence revisions to international clinical guidelines, ensuring the global dissemination of its findings.",2020,"SSI rates are significantly higher in low- and middle-income countries (LMICs) but there is little high-quality evidence on interventions to prevent SSI in LMICs.
","['5,480 patients', 'Patients with predicted clean-contaminated or contaminated/ dirty wounds with abdominal skin incision ≥5cm', 'patients in LMICs undergoing abdominal surgery', 'low- and middle-income countries']","['alcoholic chlorhexidine', 'alcoholic chlorhexidine and non-coated suture, (2) 2% alcoholic chlorhexidine and triclosan-coated suture, (3) 10% aqueous povidone-iodine and non-coated suture, and (4) 10% aqueous povidone-iodine and triclosan-coated suture', 'povidone-iodine for skin preparation, and (2) triclosan-coated suture versus non-coated suture for fascial closure']","['SSI rates', 'SSI at 30-days, based on the Centers for Disease Control definition of SSI', 'surgical site infection']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0205279', 'cui_str': 'Contaminated'}, {'cui': 'C0574780', 'cui_str': 'Wound dirty'}, {'cui': 'C0222166', 'cui_str': 'Skin structure of abdomen'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0454664', 'cui_str': 'Country'}]","[{'cui': 'C0687725', 'cui_str': 'Problem drinker'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0040958', 'cui_str': 'Triclosan'}, {'cui': 'C0032857', 'cui_str': 'Povidone-Iodine'}, {'cui': 'C0455085', 'cui_str': 'Skin preparation'}, {'cui': 'C0015641', 'cui_str': 'Fascial'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}]","[{'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0007670', 'cui_str': 'Centers for Disease Control and Prevention (U.S.)'}, {'cui': 'C3539107', 'cui_str': 'Definition'}]",5480.0,0.323638,"SSI rates are significantly higher in low- and middle-income countries (LMICs) but there is little high-quality evidence on interventions to prevent SSI in LMICs.
","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': 'University of Birmingham, Birmingham, UK.'}]",Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland,['10.1111/codi.15354']
2723,32921111,"The effect of attention and interpretation therapy on psychological resilience, cancer-related fatigue, and negative emotions of patients after colon cancer surgery.","BACKGROUND


Colon cancer is the most common malignant tumor of the gastrointestinal tract. This cancer and the related treatments bring a raft of lasting physiological and psychological impacts to patients. This study explored the effects of attention and interpretation therapy (AIT) on improving psychological resilience, cancer-related fatigue (CRF), and negative emotions in patients after colon cancer surgery.
METHODS


Patients who had undergone colon cancer surgery in the Affiliated Hospital of Jiangnan University were selected and randomly allocated into an experimental group and a control group, each with 100 cases. Patients in the control group received routine intervention measures, while the experimental group received an extra 10 weeks of AIT. Before and after 10 weeks of intervention, the effects of intervention were evaluated using the Connor-Davidson Resilience Scale (CD-RISC), Self-Rating Anxiety Scale (SAS), Selfrating Depression Scale (SDS) and the Revised Piper Fatigue Scale (PFS-R).
RESULTS


Before the intervention, there was no statistical difference between the scores of psychological resilience, CRF, and negative emotions between the two groups (P>0.05). We compared the scores before and after the 10 weeks of intervention and found that the scores of psychological resilience of the experimental group were higher than before, and the scores of CRF and negative emotion were lower than before. After the intervention, the psychological resilience score of the experimental group was higher than that of the control group, the CRF and negative emotions scores were lower than those of the control group, and the differences were statistically significant (P<0.05).
CONCLUSIONS


AIT can effectively strengthen the psychological resilience of patients after colon cancer surgery to a certain extent, reduce anxiety and depression, reduce the degree of CRF, and thus improve the patients' quality of life postoperatively.",2020,"After the intervention, the psychological resilience score of the experimental group was higher than that of the control group, the CRF and negative emotions scores were lower than those of the control group, and the differences were statistically significant (P<0.05).
","['patients after colon cancer surgery', 'Patients who had undergone colon cancer surgery in the Affiliated Hospital of Jiangnan University']","['attention and interpretation therapy (AIT', 'attention and interpretation therapy', 'routine intervention measures, while the experimental group received an extra 10 weeks of AIT']","['scores of psychological resilience, CRF, and negative emotions', 'scores of CRF and negative emotion', 'Connor-Davidson Resilience Scale (CD-RISC), Self-Rating Anxiety Scale (SAS), Selfrating Depression Scale (SDS) and the Revised Piper Fatigue Scale (PFS-R', 'psychological resilience, cancer-related fatigue (CRF), and negative emotions', 'CRF and negative emotions scores', 'psychological resilience, cancer-related fatigue, and negative emotions', 'scores of psychological resilience', 'psychological resilience score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007102', 'cui_str': 'Malignant tumor of colon'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0459471', 'cui_str': 'Interpretation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C4274302', 'cui_str': 'Cancer-related fatigue'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0330232', 'cui_str': 'Piper'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",,0.021339,"After the intervention, the psychological resilience score of the experimental group was higher than that of the control group, the CRF and negative emotions scores were lower than those of the control group, and the differences were statistically significant (P<0.05).
","[{'ForeName': 'Chunyan', 'Initials': 'C', 'LastName': 'Lin', 'Affiliation': 'Department of Gastroenterology, the Affiliated Hospital of Jiangnan University, Wuxi, China.'}, {'ForeName': ""Yu'e"", 'Initials': 'Y', 'LastName': 'Diao', 'Affiliation': 'Department of Gastroenterology, the Affiliated Hospital of Jiangnan University, Wuxi, China.'}, {'ForeName': 'Zhixia', 'Initials': 'Z', 'LastName': 'Dong', 'Affiliation': 'Department of Gastroenterology, the Affiliated Hospital of Jiangnan University, Wuxi, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Song', 'Affiliation': 'Department of Gastroenterology, the Affiliated Hospital of Jiangnan University, Wuxi, China.'}, {'ForeName': 'Chuanqing', 'Initials': 'C', 'LastName': 'Bao', 'Affiliation': 'Department of Gastroenterology, the Affiliated Hospital of Jiangnan University, Wuxi, China. mollylcy@126.com.'}]",Annals of palliative medicine,['10.21037/apm-20-1370']
2724,32921117,A clinical study of preoperative carbohydrate administration to improve insulin resistance in patients with multiple injuries.,"BACKGROUND


The purpose of this study was to investigate the tolerance and safety of carbohydrate administration to patients with multiple injuries prior to surgery, and to analyze the effects of carbohydrate intake on their immediate insulin resistance (IR), postoperative complications, and length of hospital stay.
METHODS


A total of 125 patients with mild multiple injuries who were admitted to the Emergency Surgery Department of Affiliated Hospital of Nantong University for elective surgery were randomized to administration of either placebo or carbohydrate. Finally, 82 patients (male: 39, female: 43) successfully completed the experiment and collected data. Preoperative general condition, subjective comfort, blood glucose concentration, serum insulin and insulin resistance index (IR) were studied.
RESULTS


The two groups of patients matched in gender, age, body mass index (BMI) (P>0.05). Patients in CHO group treated with carbohydrates three hours before surgery compared with patients treated with preoperative specification. The thirst, hunger and anxiety of the patients in the CHO group were significantly relieved (P<0.05). Blood glucose concentration, serum insulin, and IR were much lower in the CHO group (P<0.05).
CONCLUSIONS


It is a relatively safe approach that patients took carbohydrates 3 hours before surgery, and there was no statistically significant difference in the incidence of postoperative aspiration. Taking carbohydrates before surgery can not only relieve preoperative discomfort, but also reduce postoperative insulin resistance, which is helpful to avoid postoperative metabolic disorder and speed up recovery.",2020,"Blood glucose concentration, serum insulin, and IR were much lower in the CHO group (P<0.05).
","['82 patients (male: 39, female: 43) successfully completed the experiment and collected data', '125 patients with mild multiple injuries who were admitted to the Emergency Surgery Department of Affiliated Hospital of Nantong University for elective surgery', 'patients with multiple injuries', 'patients with multiple injuries prior to surgery']","['carbohydrates', 'carbohydrate', 'preoperative carbohydrate administration', 'placebo or carbohydrate']","['Blood glucose concentration, serum insulin, and IR', 'immediate insulin resistance (IR), postoperative complications, and length of hospital stay', 'incidence of postoperative aspiration', 'insulin resistance', 'hunger and anxiety', 'Preoperative general condition, subjective comfort, blood glucose concentration, serum insulin and insulin resistance index (IR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0026771', 'cui_str': 'Multiple injuries'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0332152', 'cui_str': 'Before'}]","[{'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C2585282', 'cui_str': 'Blood glucose concentration'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0004056', 'cui_str': 'Aspiration, Psychology'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",125.0,0.0245766,"Blood glucose concentration, serum insulin, and IR were much lower in the CHO group (P<0.05).
","[{'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Qi', 'Affiliation': 'Department of Emergency Medicine, Affiliated Hospital of Nantong University, Nantong, China.'}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Department of Emergency Medicine, Affiliated Hospital of Nantong University, Nantong, China.'}, {'ForeName': 'Linli', 'Initials': 'L', 'LastName': 'Shan', 'Affiliation': 'Department of Emergency Medicine, Affiliated Hospital of Nantong University, Nantong, China.'}, {'ForeName': 'Yansong', 'Initials': 'Y', 'LastName': 'Dong', 'Affiliation': 'Department of Emergency Medicine, Affiliated Hospital of Nantong University, Nantong, China.'}, {'ForeName': 'Guomin', 'Initials': 'G', 'LastName': 'Mao', 'Affiliation': 'Department of Emergency Medicine, Affiliated Hospital of Nantong University, Nantong, China.'}, {'ForeName': 'Guiwen', 'Initials': 'G', 'LastName': 'Liang', 'Affiliation': 'Department of Emergency Medicine, Affiliated Hospital of Nantong University, Nantong, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Gong', 'Affiliation': 'Department of Emergency Medicine, Affiliated Hospital of Nantong University, Nantong, China.'}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Xu', 'Affiliation': 'Department of Emergency Medicine, Affiliated Hospital of Nantong University, Nantong, China.'}, {'ForeName': 'Haiyan', 'Initials': 'H', 'LastName': 'Jiang', 'Affiliation': 'Department of Emergency Medicine, Affiliated Hospital of Nantong University, Nantong, China. jhy@ntu.edu.cn.'}, {'ForeName': 'Zhongwei', 'Initials': 'Z', 'LastName': 'Huang', 'Affiliation': 'Department of Emergency Medicine, Affiliated Hospital of Nantong University, Nantong, China. tdfyhuangzw@163.com.'}]",Annals of palliative medicine,['10.21037/apm-20-1424']
2725,32921123,Effects of tai chi on catheter management and quality of life in tumor patients with PICC at the intermission of chemotherapy: a non-inferiority randomized controlled trial.,"BACKGROUND


Peripherally inserted central catheter (PICC) is widely used in chemotherapy due to its minimal complications and simple wound care. This study explored the effects of tai chi on catheterrelated complications, catheter management ability, and quality of life in tumor patients with PICC at the intermission of chemotherapy.
METHODS


This study was an open parallel trial. A total of 98 patients with malignant tumors who underwent long-term chemotherapy with PICC were randomly divided into an observation group (49 cases) and a control group (49 cases). The control group received grip strength exercise for 3 months, while the observation group received 24 simplified tai chi exercises. The coagulation function, thrombosis rate, self-management ability, and quality of life were compared between the two groups before and after the intervention.
RESULTS


After the intervention, the activated partial thromboplastin time (APTT) and prothrombin time (PT) in the observation group were longer than those in the control group, while fibrinogen (FIB) was lower than that in the control group (all P<0.05). After the intervention, the total score of self-management ability of the observation group was higher than that of the control group (t=2.038, P=0.047), and the scores of exercises ability and quality of daily life with catheters were significantly increased (all P<0.05). In terms of quality of life, scores of role-physical (RP), social functioning (SF), mental health (MH) and role-emotional (RE) in the observation group were higher than those in the control group (all P<0.05), while there was no statistical difference between the bodily pain (BP) scores of the observation group and the control group (P>0.05). The incidence of venous thrombosis in the observation group was lower than that in the control group, the difference was statistically significant ( χ 2 =4.439, P=0.035).
CONCLUSIONS


Tai chi can prevent PICC thrombosis, reduce PICC-related complications, improve selfmanagement ability, and improve quality of life in at-home patients with long-term PICC.",2020,"The incidence of venous thrombosis in the observation group was lower than that in the control group, the difference was statistically significant ( χ 2 =4.439, P=0.035).
","['98 patients with malignant tumors who underwent long-term chemotherapy with PICC', 'tumor patients with PICC at the intermission of chemotherapy']","['grip strength exercise', '24 simplified tai chi exercises', 'tai chi', 'Peripherally inserted central catheter (PICC']","['incidence of venous thrombosis', 'coagulation function, thrombosis rate, self-management ability, and quality of life', 'fibrinogen (FIB', 'scores of exercises ability and quality of daily life with catheters', 'catheter management and quality of life', 'quality of life, scores of role-physical (RP), social functioning (SF), mental health (MH) and role-emotional (RE', 'total score of self-management ability', 'bodily pain (BP) scores', 'activated partial thromboplastin time (APTT) and prothrombin time (PT', 'catheterrelated complications, catheter management ability, and quality of life', 'quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0179740', 'cui_str': 'Peripherally inserted central catheter'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}]","[{'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0376403', 'cui_str': 'Tai-chi'}, {'cui': 'C0179740', 'cui_str': 'Peripherally inserted central catheter'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0042487', 'cui_str': 'Venous thrombosis'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0016006', 'cui_str': 'Fibrinogen'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0280440', 'cui_str': 'Catheter management'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030605', 'cui_str': 'Partial thromboplastin time, activated'}, {'cui': 'C0033707', 'cui_str': 'Prothrombin time'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",98.0,0.0311705,"The incidence of venous thrombosis in the observation group was lower than that in the control group, the difference was statistically significant ( χ 2 =4.439, P=0.035).
","[{'ForeName': 'Yuehua', 'Initials': 'Y', 'LastName': 'Ding', 'Affiliation': ""Department of PICC clinic, Hai'an People's Hospital, Hai'an, China.""}, {'ForeName': 'Lijun', 'Initials': 'L', 'LastName': 'Ji', 'Affiliation': ""Department of Breast and Thyroid Surgery, Jiangyin People's Hospital, Jiangyin, China.""}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': ""Department of Oncology, the Second People's Hospital of Wuxi, Wuxi, China. huyue20193@163.com.""}]",Annals of palliative medicine,['10.21037/apm-20-1456']
2726,32923016,Efficacy and safety of triazavirin therapy for coronavirus disease 2019: A pilot randomized controlled trial.,"No therapeutics have been proven effective yet for the treatment of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). To assess the efficacy and safety of Triazavirin therapy for COVID-19, we conducted a randomized, double-blinded controlled trial involving hospitalized adult patients with COVID-19. Participants were enrolled from ten sites, and were randomized into two arms of the study with a ratio of 1:1. Patients were treated with Triazavirin 250 mg versus a placebo three or four times a day for 7 d. The primary outcome was set as the time to clinical improvement, defined as normalization of body temperature, respiratory rate, oxygen saturation, cough, and absorption of pulmonary infection by chest computed tomography (CT) until 28 d after randomization. Secondary outcomes included individual components of the primary outcome, the mean time and proportion of inflammatory absorption in the lung, and the conversion rate to a repeated negative SARS-CoV-2 nucleic acid test of throat swab sampling. Concomitant therapeutic treatments, adverse events, and serious adverse events were recorded. Our study was halted after the recruitment of 52 patients, since the number of new infections in the participating hospitals decreased greatly. We randomized 52 patients for treatment with Triazavirin ( n  = 26) or a placebo ( n  = 26). We found no differences in the time to clinical improvement (median, 7 d vs. 12 d; risk ratio (RR), 2.0; 95% confidence interval (CI), 0.7-5.6;  p  = 0.2), with clinical improvement occurring in ten patients in the Triazavirin group and six patients in the placebo group (38.5% vs. 23.1%, RR, 2.1; 95% CI, 0.6-7.0;  p  = 0.2). All components of the primary outcome normalized within 28 d, with the exception of absorption of pulmonary infection (Triazavirin 50.0%, placebo 26.1%). Patients in the Triazavirin group used less frequent concomitant therapies for respiratory, cardiac, renal, hepatic, or coagulation supports. Although no statistically significant evidence was found to indicate that Triazavirin benefits COVID-19 patients, our observations indicated possible benefits from its use to treat COVID-19 due to its antiviral effects. Further study is required for confirmation.",2020,"We found no differences in the time to clinical improvement (median, 7 d vs. 12 d; risk ratio (RR), 2.0; 95% confidence interval (CI), 0.7-5.6;  p  = 0.2), with clinical improvement occurring in ten patients in the Triazavirin group and six patients in the placebo group (38.5% vs. 23.1%, RR, 2.1; 95% CI, 0.6-7.0;  p  = 0.2).","['Participants were enrolled from ten sites', 'hospitalized adult patients with COVID-19', 'coronavirus disease 2019']","['placebo', 'Triazavirin', 'Triazavirin therapy', 'triazavirin therapy']","['time to clinical improvement, defined as normalization of body temperature, respiratory rate, oxygen saturation, cough, and absorption of pulmonary infection by chest computed tomography (CT', 'time to clinical improvement', 'mean time and proportion of inflammatory absorption in the lung, and the conversion rate to a repeated negative SARS-CoV-2 nucleic acid test of throat swab sampling', 'frequent concomitant therapies for respiratory, cardiac, renal, hepatic, or coagulation supports', 'efficacy and safety', 'absorption of pulmonary infection', 'adverse events, and serious adverse events', 'Efficacy and safety']","[{'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2714695', 'cui_str': 'triazavirin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0876973', 'cui_str': 'Infectious disease of lung'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0028606', 'cui_str': 'Nucleic acid'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439056', 'cui_str': 'Throat swab'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",52.0,0.423282,"We found no differences in the time to clinical improvement (median, 7 d vs. 12 d; risk ratio (RR), 2.0; 95% confidence interval (CI), 0.7-5.6;  p  = 0.2), with clinical improvement occurring in ten patients in the Triazavirin group and six patients in the placebo group (38.5% vs. 23.1%, RR, 2.1; 95% CI, 0.6-7.0;  p  = 0.2).","[{'ForeName': 'Xiaoke', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': ', ,.'}, {'ForeName': 'Kaijiang', 'Initials': 'K', 'LastName': 'Yu', 'Affiliation': ', ,.'}, {'ForeName': 'Yongchen', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ', ,.'}, {'ForeName': 'Wanhai', 'Initials': 'W', 'LastName': 'Xu', 'Affiliation': ', ,.'}, {'ForeName': 'Hongli', 'Initials': 'H', 'LastName': 'Ma', 'Affiliation': ', ,.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Hou', 'Affiliation': ', ,.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ', ,.'}, {'ForeName': 'Benzhi', 'Initials': 'B', 'LastName': 'Cai', 'Affiliation': ', ,.'}, {'ForeName': 'Liying', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': ', ,.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': ', ,.'}, {'ForeName': 'Xiaoli', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': ', ,.'}, {'ForeName': 'Jingshu', 'Initials': 'J', 'LastName': 'Gao', 'Affiliation': ', ,.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ', ,.'}, {'ForeName': 'Huichao', 'Initials': 'H', 'LastName': 'Qin', 'Affiliation': ', ,.'}, {'ForeName': 'Wenjie', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': ', ,.'}, {'ForeName': 'Mingyan', 'Initials': 'M', 'LastName': 'Zhao', 'Affiliation': ', ,.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': ', ,.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ', ,.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': ', ,.'}, {'ForeName': 'Kang', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': ', ,.'}, {'ForeName': 'Zhimin', 'Initials': 'Z', 'LastName': 'Du', 'Affiliation': ', ,.'}, {'ForeName': 'Ben Willem J', 'Initials': 'BWJ', 'LastName': 'Mol', 'Affiliation': ', ,.'}, {'ForeName': 'Baofeng', 'Initials': 'B', 'LastName': 'Yang', 'Affiliation': ', ,.'}]","Engineering (Beijing, China)",['10.1016/j.eng.2020.08.011']
2727,32924312,Composite restorations placed in non-carious cervical lesions-Which cavity preparation is clinically reliable?,"The purpose of this in-vivo study was to evaluate the clinical performance of restorations placed in non-carious cervical lesions (NCCLs), using different cavity preparation designs, after 7.7 years. A total of 85 NCCLs with coronal margins in enamel and cervical margins in dentin were randomly assigned to the following treatment protocols: dentin surface cleaning, dentin surface roughening with round bur plus flowable composite, dentin surface roughening/cervical groove preparation with round bur, dentin surface roughening/cervical groove preparation with round bur plus flowable composite. After enamel beveling and selective enamel etching, the defects were restored with composite. The restorations were assessed by two independent, calibrated and blinded investigators, using modified USPHS criteria. At 7 years (7.7 (± 0.35)), a total of 64 restorations (75.3%) were available for follow-up examination. The total retention rate, irrespective of the test groups, was 82.8%. Restorations placed without any preparation showed the highest loss rate (27.8%). Esthetic appearance, marginal adaptation, anatomic form and marginal discoloration did not differ significantly between the groups. Composites are long-term stable materials for restoring NCCLs. Restorations placed without any dentin preparation (cavity cleaning only) showed the highest loss rate.",2020,"Esthetic appearance, marginal adaptation, anatomic form and marginal discoloration did not differ significantly between the groups.",['A total of 85 NCCLs with coronal margins in enamel and cervical margins in dentin'],"['dentin surface cleaning, dentin surface roughening with round bur plus flowable composite, dentin surface roughening/cervical groove preparation with round bur, dentin surface roughening/cervical groove preparation with round bur plus flowable composite']","['total retention rate', 'Esthetic appearance, marginal adaptation, anatomic form and marginal discoloration', 'highest loss rate']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4274086', 'cui_str': 'Non carious lesion at cervical margin of tooth'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}]","[{'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0332490', 'cui_str': 'Round shape'}, {'cui': 'C0700351', 'cui_str': 'Bur'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0673997', 'cui_str': 'flowable hybrid composite'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0332572', 'cui_str': 'Abnormal color'}, {'cui': 'C0205250', 'cui_str': 'High'}]",85.0,0.0489112,"Esthetic appearance, marginal adaptation, anatomic form and marginal discoloration did not differ significantly between the groups.","[{'ForeName': 'Anne-Katrin', 'Initials': 'AK', 'LastName': 'Lührs', 'Affiliation': 'Department of Conservative Dentistry, Periodontology and Preventive Dentistry, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Silke', 'Initials': 'S', 'LastName': 'Jacker-Guhr', 'Affiliation': 'Department of Conservative Dentistry, Periodontology and Preventive Dentistry, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Hüsamettin', 'Initials': 'H', 'LastName': 'Günay', 'Affiliation': 'Department of Conservative Dentistry, Periodontology and Preventive Dentistry, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Peggy', 'Initials': 'P', 'LastName': 'Herrmann', 'Affiliation': 'Department of Conservative Dentistry, Periodontology and Preventive Dentistry, Hannover Medical School, Hannover, Germany.'}]",Clinical and experimental dental research,['10.1002/cre2.310']
2728,32927668,Cocoa-Rich Chocolate and Quality of Life in Postmenopausal Women: A Randomized Clinical Trial.,"Menopause has a negative impact on quality of life (QoL). The aim of the present study was to analyse the effect on QoL of adding 10 g per day of chocolate with a high concentration of cocoa (99%) to the habitual diet, for 6 months, in a sample of postmenopausal women. Postmenopausal women ( n  = 140) aged 50-64 years were randomised to either an addition of 10 g per day of cocoa-rich chocolate to their usual diet or no supplement addition. All variables were measured at baseline and after six months of intervention. QoL was evaluated using the 3-level version of EuroQol-5D (EuroQoL-5D-3L), the EuroQol Visual Analogue Scale (EQ-VAS) and the Cervantes scale. Analysis of covariance (ANCOVA) analyses adjusted for the main determinants of QoL considered in this study showed no changes in the global score of QoL evaluated with the EuroQoL-5D-3L. The intervention group showed an increase of 6.0 points (95% confidence interval (CI): 0.4, 11.7) in the EQ-VAS compared to the control group ( p  = 0.036). No significant changes were observed between groups in the global score of QoL nor in the dimensions and subdimensions measured with the Cervantes scale. The additional daily contribution of 10 g of cocoa-rich chocolate in postmenopausal women could have a slight impact on their perception toward their health state, although without modifying the health-related QoL or the dimensions that compose it.",2020,No significant changes were observed between groups in the global score of QoL nor in the dimensions and subdimensions measured with the Cervantes scale.,"['Postmenopausal Women', 'Postmenopausal women ( n  = 140) aged 50-64 years', 'postmenopausal women']","['cocoa-rich chocolate', 'Cocoa-Rich Chocolate', 'chocolate with a high concentration of cocoa (99%) to the habitual diet', 'cocoa-rich chocolate to their usual diet or no supplement addition']","['3-level version of EuroQol-5D (EuroQoL-5D-3L), the EuroQol Visual Analogue Scale (EQ-VAS) and the Cervantes scale', 'global score of QoL', 'quality of life (QoL']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0006622', 'cui_str': 'Theobroma cacao'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0456949', 'cui_str': 'Level 3'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",140.0,0.0901054,No significant changes were observed between groups in the global score of QoL nor in the dimensions and subdimensions measured with the Cervantes scale.,"[{'ForeName': 'Irene A', 'Initials': 'IA', 'LastName': 'Garcia-Yu', 'Affiliation': 'Instituto de Investigación Biomédica de Salamanca (IBSAL), Unidad de Investigación de Atención Primaria de Salamanca (APISAL), Servicio de Salud de Castilla y León (SACyL), 37005 Salamanca, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Garcia-Ortiz', 'Affiliation': 'Instituto de Investigación Biomédica de Salamanca (IBSAL), Unidad de Investigación de Atención Primaria de Salamanca (APISAL), Servicio de Salud de Castilla y León (SACyL), 37005 Salamanca, Spain.'}, {'ForeName': 'Manuel A', 'Initials': 'MA', 'LastName': 'Gomez-Marcos', 'Affiliation': 'Instituto de Investigación Biomédica de Salamanca (IBSAL), Unidad de Investigación de Atención Primaria de Salamanca (APISAL), Servicio de Salud de Castilla y León (SACyL), 37005 Salamanca, Spain.'}, {'ForeName': 'Emiliano', 'Initials': 'E', 'LastName': 'Rodriguez-Sanchez', 'Affiliation': 'Instituto de Investigación Biomédica de Salamanca (IBSAL), Unidad de Investigación de Atención Primaria de Salamanca (APISAL), Servicio de Salud de Castilla y León (SACyL), 37005 Salamanca, Spain.'}, {'ForeName': 'Olaya', 'Initials': 'O', 'LastName': 'Tamayo-Morales', 'Affiliation': 'Instituto de Investigación Biomédica de Salamanca (IBSAL), Unidad de Investigación de Atención Primaria de Salamanca (APISAL), Servicio de Salud de Castilla y León (SACyL), 37005 Salamanca, Spain.'}, {'ForeName': 'Jose A', 'Initials': 'JA', 'LastName': 'Maderuelo-Fernandez', 'Affiliation': 'Instituto de Investigación Biomédica de Salamanca (IBSAL), Unidad de Investigación de Atención Primaria de Salamanca (APISAL), Servicio de Salud de Castilla y León (SACyL), 37005 Salamanca, Spain.'}, {'ForeName': 'Jose I', 'Initials': 'JI', 'LastName': 'Recio-Rodriguez', 'Affiliation': 'Instituto de Investigación Biomédica de Salamanca (IBSAL), Unidad de Investigación de Atención Primaria de Salamanca (APISAL), Servicio de Salud de Castilla y León (SACyL), 37005 Salamanca, Spain.'}]",Nutrients,['10.3390/nu12092754']
2729,32932009,"The preliminary effects of henna on chemotherapy-induced peripheral neuropathy in women receiving oxaliplatin-based treatment: A parallel-group, randomized, controlled pilot trial.","PURPOSE


Chemotherapy-induced peripheral neuropathy (CIPN) may frequently occur in patients receiving oxaliplatin-based treatment. The aim of the present parallel-group, randomized, controlled pilot trial was to investigate the effect of henna on CIPN in women receiving oxaliplatin-based treatment.
METHOD


Sixty female patients receiving oxaliplatin-based treatment were randomly divided into two groups, i.e., one intervention group (n = 30) where henna was applied topically and one control group (n = 30) that received routine treatment and care. Women in the intervention group were provided a pack of henna prepared by the investigators following each treatment course (2nd, 3rd, and 4th courses) and were instructed to apply the henna on their palms, fingers, and soles. The chemotherapy-induced peripheral neuropathy assessment tool (CIPNAT) was completed by women subsequent to the 2nd (baseline), 3rd, and 4th courses of treatment.
RESULTS


The intragroup assessment performed for the intervention group revealed that the total CIPNAT score significantly declined in the intervention group (p < 0.05). The score changes by time in the intervention and control groups were in favour of the intervention group, and the effect size for group × time interaction was η 2  = 0.169. Similarly, regarding the symptoms intervention section of the tool, a positive change by time in the intervention group was observed, and the effect size concerning this change was large, i.e., η 2  = 0.284.
CONCLUSIONS


The present study results showed that henna application on hands and feet has a beneficial effect on peripheral neuropathy. Applying henna is a promising approach in CIPN management.",2020,"The score changes by time in the intervention and control groups were in favour of the intervention group, and the effect size for group ","['women receiving oxaliplatin-based treatment', 'patients receiving oxaliplatin-based treatment', 'Sixty female patients receiving oxaliplatin-based treatment']","['henna was applied topically and one control group (n\xa0=\xa030) that received routine treatment and care', 'chemotherapy-induced peripheral neuropathy assessment tool (CIPNAT']",['total CIPNAT score'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0064698', 'cui_str': 'lawsone'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3873567', 'cui_str': 'Peripheral neuropathy due to and following chemotherapy'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0336791', 'cui_str': 'Tool'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C3873567', 'cui_str': 'Peripheral neuropathy due to and following chemotherapy'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",60.0,0.0266703,"The score changes by time in the intervention and control groups were in favour of the intervention group, and the effect size for group ","[{'ForeName': 'Selda', 'Initials': 'S', 'LastName': 'Arslan', 'Affiliation': 'Necmettin Erbakan University, Faculty of Nursing, Konya, Turkey. Electronic address: seldaarslan@erbakan.edu.tr.'}, {'ForeName': 'Pinar', 'Initials': 'P', 'LastName': 'Zorba Bahceli', 'Affiliation': 'Izmir Bakircay University, Faculty of Health Sciences, Nursing Department, Izmir, Turkey. Electronic address: pinarzorba85@gmail.com.'}, {'ForeName': 'Yeter', 'Initials': 'Y', 'LastName': 'İlik', 'Affiliation': 'Necmettin Erbakan University, Faculty of Medicine, Konya, Turkey. Electronic address: yeteriner@gmail.com.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Artaç', 'Affiliation': 'Necmettin Erbakan University, Faculty of Medicine, Konya, Turkey. Electronic address: mehmetartac@yahoo.com.'}]",European journal of oncology nursing : the official journal of European Oncology Nursing Society,['10.1016/j.ejon.2020.101827']
2730,32932051,Measuring upper limb disability for patients with neck pain: Evaluation of the feasibility of the single arm military press (SAMP) test.,"BACKGROUND


Non-specific neck pain (NSNP) is frequently associated with upper limb disability (ULD). Consequently, evaluation of ULD using an outcome measure is necessary during the management of patients with NSNP. The Single Arm Military Press (SAMP) test is a performance-based ULD measure developed for populations with neck pain. During the SAMP test, patients are asked to repeatedly lift a weight above their head for 30 s. The number of repetitions is counted. Its clinical utility in a patient group is still unknown.
OBJECTIVE


This study investigates the feasibility of the SAMP test from patients and clinicians' perspectives.
METHODS


Seventy female patients with NSNP were randomly allocated into one of three groups. Participants in each group completed the SAMP test using one of three proposed weights (½kg, 1 kg or 1½kg). The feasibility of the SAMP test was established using structured qualitative exit feedback interviews for patients and administrating clinicians.
RESULTS


Participants using ½kg achieved the highest number of repetitions, but a high proportion reported the weight as extremely light, whereas those who tested using the 1½kg achieved the lowest number of repetitions and participants reported the weight as being heavy. Participants tested using 1 kg achieved an average number of repetitions and a high proportion reported the weight as acceptably heavy. Clinicians and patients reported that the SAMP test was efficient and convenient.
CONCLUSION


The 1 kg SAMP test is feasible for use in female patients with NSNP. The measurement properties of the SAMP test should be determined in a patient group.",2020,The Single Arm Military Press (SAMP) test is a performance-based ULD measure developed for populations with neck pain.,"[""patients and clinicians' perspectives"", 'patients and administrating clinicians', 'Seventy female patients with NSNP', 'female patients with NSNP', 'patients with NSNP', 'populations with neck pain', 'patients with neck pain']",[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0032659', 'cui_str': 'Population'}]",[],[],70.0,0.0379593,The Single Arm Military Press (SAMP) test is a performance-based ULD measure developed for populations with neck pain.,"[{'ForeName': 'Ahmad Salah Eldin', 'Initials': 'ASE', 'LastName': 'Alreni', 'Affiliation': 'Faculty of Medicine and Health Science, University of Antwerp, Campus Drie Eiken, Universiteitsplein 1, D.R.319, 2610, Wilrijk, Belgium. Electronic address: Ahmad.Alreni@uantwerpen.be.'}, {'ForeName': 'Heba Roohy', 'Initials': 'HR', 'LastName': 'Abdo Aboalmaty', 'Affiliation': 'Department of Sports Training and Kinesiology, Tanta University El-Gaish Street, Tanta Qism 2, Tanta, Garbia Government, Egypt. Electronic address: hebaabdoaboalmaty@outlook.com.'}, {'ForeName': 'Willem', 'Initials': 'W', 'LastName': 'De Hertogh', 'Affiliation': 'Faculty of Medicine and Health Science, University of Antwerp, Campus Drie Eiken, Universiteitsplein 1, D.R.319, 2610, Wilrijk, Belgium. Electronic address: willem.dehertogh@uantwerpen.be.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Meirte', 'Affiliation': 'Faculty of Medicine and Health Science, University of Antwerp, Campus Drie Eiken, Universiteitsplein 1, D.R.319, 2610, Wilrijk, Belgium. Electronic address: jill.meirte@uantwerpen.be.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Harrop', 'Affiliation': 'Centre for Health and Social Care Research, Faculty of Health and Wellbeing, Sheffield Hallam University, Sheffield, United Kingdom. Electronic address: D.Harrop@shu.ac.uk.'}, {'ForeName': 'Sionnadh Mairi', 'Initials': 'SM', 'LastName': 'McLean', 'Affiliation': 'Centre for Health and Social Care Research, Faculty of Health and Wellbeing, Sheffield Hallam University, Sheffield, United Kingdom. Electronic address: s.mclean@shu.ac.uk.'}]",Musculoskeletal science & practice,['10.1016/j.msksp.2020.102254']
2731,32932174,"The effects of zinc supplementation on metabolic profile and oxidative stress in overweight/obese patients with non-alcoholic fatty liver disease: A randomized, double-blind, placebo-controlled trial.","BACKGROUND


Evidence indicates the positive effects of zinc on insulin resistance and oxidative stress in metabolic syndrome or diabetes. Non-alcoholic fatty liver disease (NAFLD) is the main hepatic manifestation of insulin resistance and metabolic syndrome. The present study is the first clinical trial that evaluated the effects of zinc supplementation on metabolic and oxidative stress status in overweight/obese patients with NAFLD undergoing calorie- restriction diet.
METHODS


Fifty six overweight/obese patients with confirmed mild to moderate NAFLD using ultrasonography were randomly allocated to receive 30 mg elemental zinc supplement (n = 29) or placebo (n = 27) along with weight loss diet for 12 weeks. Serum levels of zinc, homeostasis model of assessment-estimated insulin resistance (HOMA-IR), lipid profile, serum superoxide dismutas1 (SOD1) and malondialdhyde (MDA) levels were assessed.
RESULTS


Serum levels of insulin, SOD1, MDA and HOMA-IR were improved in the treatment group (p < 0.05). Within group comparison showed significant reduction in serum FBS, HbA 1C , TC, LDL-c and TG in the treatment group.
CONCLUSION


Zinc supplementation for three months improved insulin resistance and oxidative stress status in overweight/obese NAFLD patients with no beneficial effects on lipid profiles over weight loss diet. Registration ID in IRCT (IRCT NO: 20181005041238N1).",2020,"RESULTS


Serum levels of insulin, SOD1, MDA and HOMA-IR were improved in the treatment group (p < 0.05).","['alcoholic fatty liver disease (NAFLD', 'overweight/obese patients with non-alcoholic fatty liver disease', 'metabolic syndrome or diabetes', 'overweight/obese patients with NAFLD undergoing calorie- restriction diet', 'overweight/obese NAFLD patients', 'Fifty six overweight/obese patients with confirmed mild to moderate NAFLD using ultrasonography']","['Zinc supplementation', '30\u202fmg elemental zinc supplement', 'IRCT', 'placebo', 'zinc supplementation']","['Serum levels of insulin, SOD1, MDA and HOMA-IR', 'serum FBS, HbA 1C , TC, LDL-c and TG', 'metabolic and oxidative stress status', 'insulin resistance and oxidative stress status', 'Serum levels of zinc, homeostasis model of assessment-estimated insulin resistance (HOMA-IR), lipid profile, serum superoxide dismutas1 (SOD1) and malondialdhyde (MDA) levels', 'metabolic profile and oxidative stress']","[{'cui': 'C0015696', 'cui_str': 'Alcoholic fatty liver'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}]","[{'cui': 'C4524022', 'cui_str': 'Zinc supplementation'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0038836', 'cui_str': 'Superoxide'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C3495427', 'cui_str': 'Fanconi-Bickel Syndrome'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C1328813', 'cui_str': 'Metabolomics'}]",56.0,0.385469,"RESULTS


Serum levels of insulin, SOD1, MDA and HOMA-IR were improved in the treatment group (p < 0.05).","[{'ForeName': 'Mojdeh', 'Initials': 'M', 'LastName': 'Fathi', 'Affiliation': 'Department of Clinical Nutrition, School of Nutrition and Food Science, Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Pezhman', 'Initials': 'P', 'LastName': 'Alavinejad', 'Affiliation': 'Alimentary Tract Research Center, Ahvaz Imam Hospital, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Haidari', 'Affiliation': 'Department of Biostatistics and Epidemiology, School of Health, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Amani', 'Affiliation': 'Department of Clinical Nutrition, School of Nutrition and Food Science, Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: r_amani@mail.mui.ac.ir.'}]",Journal of trace elements in medicine and biology : organ of the Society for Minerals and Trace Elements (GMS),['10.1016/j.jtemb.2020.126635']
2732,32933009,Modifications of Gut Microbiota after Grape Pomace Supplementation in Subjects at Cardiometabolic Risk: A Randomized Cross-Over Controlled Clinical Trial.,"Polyphenols are dietary bioactive compounds able to induce modifications in the gut microbiota profile, although more clinical studies are needed. With this aim, a randomized cross-over clinical trial was conducted, where 49 subjects at cardiometabolic risk (exhibiting at least two metabolic syndrome factors) were supplemented with a daily dose of 8 g of grape pomace (GP) for 6 weeks, with an equivalent control (CTL) period. The levels of total bacteria and Bacteroidetes, Firmicutes, Lactobacilliales,  Bacteroides  and  Prevotella  were estimated in fecal DNA by quantitative real-time PCR (qPCR), while fecal short-chain fatty acids (SCFAs) were assessed by gas chromatography. Several cardiometabolic markers were evaluated in blood samples. GP reduced insulin levels only in half of the participants (responders). GP supplementation did not cause significant modifications in the microbiota profile of the whole group, except for a tendency ( p  = 0.059) towards a decrease in the proportion of Lactobacilliales, while it increased the proportion of  Bacteroides  in non-responder subjects. The reduction of insulin levels in subjects at cardiometabolic risk upon GP supplementation appears not to be induced by changes in the major subgroups of gut microbiota. Further studies at the species level may help to elucidate the possible role of microbiota in GP-induced insulinemic status.",2020,"GP supplementation did not cause significant modifications in the microbiota profile of the whole group, except for a tendency ( p  = 0.059) towards a decrease in the proportion of Lactobacilliales, while it increased the proportion of  Bacteroides  in non-responder subjects.","['subjects at cardiometabolic risk upon', '49 subjects at cardiometabolic risk (exhibiting at least two metabolic syndrome factors', 'Subjects at Cardiometabolic Risk']","['GP supplementation', 'Gut Microbiota after Grape Pomace Supplementation']","['GP reduced insulin levels', 'levels of total bacteria and Bacteroidetes, Firmicutes, Lactobacilliales,  Bacteroides  and  Prevotella  were estimated in fecal DNA by quantitative real-time PCR (qPCR), while fecal short-chain fatty acids (SCFAs', 'microbiota profile', 'proportion of Lactobacilliales', 'insulin levels']","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0015272', 'cui_str': 'Exhibits as Topic'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}]","[{'cui': 'C0018208', 'cui_str': 'Grapes'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}]","[{'cui': 'C0018208', 'cui_str': 'Grapes'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0242946', 'cui_str': 'Prevotella'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic acid'}, {'cui': 'C1709846', 'cui_str': 'Real-Time PCR'}, {'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}]",,0.0244715,"GP supplementation did not cause significant modifications in the microbiota profile of the whole group, except for a tendency ( p  = 0.059) towards a decrease in the proportion of Lactobacilliales, while it increased the proportion of  Bacteroides  in non-responder subjects.","[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Ramos-Romero', 'Affiliation': 'Institute of Advanced Chemistry of Catalonia (IQAC-CSIC), Jordi Girona 18-26, 08034 Barcelona, Spain.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Martínez-Maqueda', 'Affiliation': 'Department of Metabolism and Nutrition, Institute of Food Science, Technology and Nutrition (ICTAN-CSIC), José Antonio Novais 10, 28040 Madrid, Spain.'}, {'ForeName': 'Mercè', 'Initials': 'M', 'LastName': 'Hereu', 'Affiliation': 'Institute of Advanced Chemistry of Catalonia (IQAC-CSIC), Jordi Girona 18-26, 08034 Barcelona, Spain.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Amézqueta', 'Affiliation': ""Departament d'Enginyeria Química i Química Analítica, Institut de Biomedicina (IBUB), Universitat de Barcelona, Carrer de Martí i Franquès, 1-11, 08028 Barcelona, Spain.""}, {'ForeName': 'Josep Lluís', 'Initials': 'JL', 'LastName': 'Torres', 'Affiliation': 'Institute of Advanced Chemistry of Catalonia (IQAC-CSIC), Jordi Girona 18-26, 08034 Barcelona, Spain.'}, {'ForeName': 'Jara', 'Initials': 'J', 'LastName': 'Pérez-Jiménez', 'Affiliation': 'Department of Metabolism and Nutrition, Institute of Food Science, Technology and Nutrition (ICTAN-CSIC), José Antonio Novais 10, 28040 Madrid, Spain.'}]","Foods (Basel, Switzerland)",['10.3390/foods9091279']
2733,32915800,Public stigma towards prolonged grief disorder: Does diagnostic labeling matter?,"The recent introduction of prolonged grief disorder (PGD) as a diagnostic category may cause negative social reactions (i.e. public stigma). Vignette experiments demonstrate that persons with both PGD symptoms and a PGD diagnosis elicit more public stigma than persons who experience integrated grief. However, the strength of the influence of the diagnosis itself remains unclear: We aimed to clarify if the diagnostic label PGD produces additional public stigma beyond PGD symptoms. We further compared whether public stigma varies between the label PGD and the label major depressive episode (MDE) (when PGD symptoms are present) and if gender of the bereaved person influences public stigma or moderates the aforementioned effects. Eight-hundred fifty-two participants (77% female; Mage = 32.6 years, SD = 13.3) were randomly assigned to read online one of eight vignettes describing either a bereaved male or female, with PGD symptoms and PGD diagnosis; PGD symptoms and MDE diagnosis; PGD symptoms and no diagnosis, or no PGD symptoms and no diagnosis (i.e., integrated grief). Following the vignettes, participants indicated which negative characteristics they ascribed to the person, their emotional reactions, and preferred social distance from the person. People with PGD symptoms and PGD (or MDE) diagnosis were attributed more negative characteristics, and elicited more negative emotions and a stronger desire for social distance than people with integrated grief. However, public stigma did not differ for people with both PGD symptoms and diagnosis compared to people only experiencing PGD symptoms. Gender of the bereaved only had an influence on desired social distance, which was larger towards men. Helping severely distressed bereaved people (regardless of diagnostic status) cope with negative social reactions may help them adapt to bereavement. Results demonstrate that the experience of severe grief reactions, yet not a diagnostic label per se, causes public stigma.",2020,"However, public stigma did not differ for people with both PGD symptoms and diagnosis compared to people only experiencing PGD symptoms.","['Public stigma towards prolonged grief disorder', 'persons with both PGD symptoms', 'People with PGD symptoms and PGD (or MDE) diagnosis', 'Eight-hundred fifty-two participants (77% female; Mage = 32.6 years, SD = 13.3) were randomly assigned to read online one of eight vignettes describing either a bereaved male or female, with PGD symptoms and PGD diagnosis; PGD symptoms and MDE diagnosis; PGD symptoms and no diagnosis, or no PGD symptoms and no diagnosis (i.e., integrated grief']",[],"['public stigma', 'severe grief reactions']","[{'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C4511668', 'cui_str': 'Prolonged grief disorder'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0024517', 'cui_str': 'Major depression, single episode'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C4319570', 'cui_str': '52'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0018235', 'cui_str': 'Normal grief reaction'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0560182', 'cui_str': 'Diagnosis not made'}]",[],"[{'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018235', 'cui_str': 'Normal grief reaction'}]",852.0,0.0295721,"However, public stigma did not differ for people with both PGD symptoms and diagnosis compared to people only experiencing PGD symptoms.","[{'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Gonschor', 'Affiliation': 'Clinical Psychology and Psychotherapy, Department of Psychology, Philipps-University Marburg, Marburg, Germany.'}, {'ForeName': 'Maarten C', 'Initials': 'MC', 'LastName': 'Eisma', 'Affiliation': 'Department of Clinical Psychology and Experimental Psychopathology, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Barke', 'Affiliation': 'Clinical and Biological Psychology, Department of Psychology, Catholic University Eichstaett-Ingolstadt, Eichstaett, Germany.'}, {'ForeName': 'Bettina K', 'Initials': 'BK', 'LastName': 'Doering', 'Affiliation': 'Clinical and Biological Psychology, Department of Psychology, Catholic University Eichstaett-Ingolstadt, Eichstaett, Germany.'}]",PloS one,['10.1371/journal.pone.0237021']
2734,32915843,Derivation and validation of the J-CTO extension score for pre-procedural prediction of major adverse cardiac and cerebrovascular events in patients with chronic total occlusions.,"We developed a prediction model of long-term risk after percutaneous coronary intervention (PCI) for coronary chronic total occlusion (CTO) based on pre-procedural clinical information. A total of 4,139 eligible patients, who underwent CTO-PCI at 52 Japanese centers were included. Specifically, 1,909 patients with 1-year data were randomly divided into the derivation (n = 1,273) and validation (n = 636) groups. Major adverse cardiac and cardiovascular event (MACCE) was the primary endpoint, including death, stroke, revascularization, and non-fatal myocardial infarction. We assessed the performance of our model using the area under the receiver operating characteristic curve (AUC) and assigned a simplified point-scoring system. One-hundred-thirty-eight (10.8%) patients experienced MACCE in the derivation cohort with hemodialysis (HD: odds ratio [OR] = 2.55), left ventricular ejection fractions (LVEF) <35% (OR = 2.23), in-stent occlusions (ISO: OR = 2.27), and diabetes mellitus (DM: OR = 1.72). The AUC of the derivation model was 0.650. The model's performance was similar in the validation cohort (AUC, 0.610). When assigned a point for each associated factor (HD = 3, LVEF <35%, ISO = 2, and DM = 1 point), the average predicted versus the observed MACCE probability using the Japan-CTO extension score for the low, moderate, high, and very high risk groups was 8.1% vs. 7.3%, 16.9% vs. 15.9%, 22.0% vs. 26.1%, and 56.2% vs. 44.4%, respectively. This novel risk model may allow for the estimation of long-term risk and be useful in disseminating appropriate revascularization procedures.",2020,"The model's performance was similar in the validation cohort (AUC, 0.610).","['1,909 patients with 1-year data were randomly divided into the derivation (n = 1,273) and validation (n = 636) groups', 'LVEF) <35% (OR = 2.23), in-stent occlusions (ISO: OR = 2.27), and diabetes mellitus (DM: OR = 1.72', '4,139 eligible patients, who underwent CTO-PCI at 52 Japanese centers were included', 'patients with chronic total occlusions']",['percutaneous coronary intervention (PCI'],"['left ventricular ejection fractions', 'death, stroke, revascularization, and non-fatal myocardial infarction', 'observed MACCE probability using the Japan-CTO extension score', 'Major adverse cardiac and cardiovascular event (MACCE', 'coronary chronic total occlusion (CTO']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0919560', 'cui_str': 'Stent occlusion'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C4517513', 'cui_str': '1.72'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",4139.0,0.0277774,"The model's performance was similar in the validation cohort (AUC, 0.610).","[{'ForeName': 'Soichiro', 'Initials': 'S', 'LastName': 'Ebisawa', 'Affiliation': 'Department of Cardiovascular Medicine, Shinshu University School of Medicine, Matsumoto, Japan.'}, {'ForeName': 'Shun', 'Initials': 'S', 'LastName': 'Kohsaka', 'Affiliation': 'Department of Cardiology, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Toshiya', 'Initials': 'T', 'LastName': 'Muramatsu', 'Affiliation': 'Cardiovascular Center, Tokyo General Hospital, Tokyo, Japan.'}, {'ForeName': 'Yoshifumi', 'Initials': 'Y', 'LastName': 'Kashima', 'Affiliation': 'Division of Cardiology, Sapporo Cardio Vascular Clinic, Hokkaido, Japan.'}, {'ForeName': 'Atsunori', 'Initials': 'A', 'LastName': 'Okamura', 'Affiliation': 'Division of Cardiology, Sakurabashi-Watanabe Hospital, Osaka, Japan.'}, {'ForeName': 'Masahisa', 'Initials': 'M', 'LastName': 'Yamane', 'Affiliation': 'Cardiology Department, Saitama Sekishinkai Hospital, Saitama, Japan.'}, {'ForeName': 'Masami', 'Initials': 'M', 'LastName': 'Sakurada', 'Affiliation': 'Department of Cardiology, Tokorozawa Heart Center, Saitama, Japan.'}, {'ForeName': 'Shunsuke', 'Initials': 'S', 'LastName': 'Matsuno', 'Affiliation': 'Department of Cardiovascular Medicine, The Cardiovascular Institute, Tokyo, Japan.'}, {'ForeName': 'Mikihiro', 'Initials': 'M', 'LastName': 'Kijima', 'Affiliation': 'Cardiology and Vascular Medicine, Hoshi General Hospital, Fukushima, Japan.'}, {'ForeName': 'Maoto', 'Initials': 'M', 'LastName': 'Habara', 'Affiliation': 'Department of Cardiovascular Medicine, Toyohashi Heart Center, Aichi, Japan.'}]",PloS one,['10.1371/journal.pone.0238640']
2735,32915891,Effect of the trajectory of exertional breathlessness on symptom recall and anticipation: A randomized controlled trial.,"BACKGROUND


Breathlessness is a major cause of physical limitation. Recalled breathlessness intensity may differ from experienced intensity and be influenced by the intensity trajectory including the 'peak-end rule'. The primary aim was to test if adding two minutes of low intensity exercise at the end of an exercise test would change the recalled breathlessness. Secondary aims included to analyse the impact of the peak and end exertional breathlessness intensity on breathlessness recall.
METHODS


Randomized controlled trial of 92 adults referred for exercise testing who were randomized (1:1), at test end, to 2 minutes of additional low intensity exercise (intervention; n = 47) or stopping at peak exertion (control; n = 45). Experienced breathlessness during the test and recalled intensity (30 min after the test) was assessed using the Borg CR10 scale.
RESULTS


Participants were aged a mean 59 years; 61% men; 79% reported a mMRC ≥1. There was no between-group difference in recalled breathlessness intensity, 5.51 ([95% CI] 5.00 to 6.01) vs. 5.73 (5.27 to 6.20; p = 0.52) in controls, even though the intervention group had a significantly lower end breathlessness (mean difference 0.96; 0.24 to 1.67; p = 0.009). Recalled exertional breathlessness was most strongly related to peak breathlessness (r2 = 0.43). When analyzed together, end breathlessness did not add any explanatory value above that of peak breathlessness.
CONCLUSION


Adding an episode of two minutes of lower exercise and breathlessness intensity at the end of an exercise test did not affect symptom recall, which was most strongly related to peak breathlessness intensity.
TRIAL REGISTRATION


ClinicalTrials.gov (NCT03468205).",2020,"There was no between-group difference in recalled breathlessness intensity, 5.51 ([95% CI] 5.00 to 6.01) vs. 5.73 (5.27 to 6.20; p = 0.52) in controls, even though the intervention group had a significantly lower end breathlessness (mean difference 0.96; 0.24 to 1.67; p = 0.009).","['92 adults referred for exercise testing', 'Participants were aged a mean 59 years; 61% men; 79% reported a mMRC ≥1']","['low intensity exercise', 'additional low intensity exercise (intervention; n = 47) or stopping at peak exertion']","['symptom recall and anticipation', 'peak breathlessness', 'recalled breathlessness intensity', 'Recalled breathlessness intensity', 'end breathlessness', 'Experienced breathlessness', 'Recalled exertional breathlessness', 'peak and end exertional breathlessness intensity on breathlessness recall']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0684224', 'cui_str': 'Report'}]","[{'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0444930', 'cui_str': 'End'}]",92.0,0.194385,"There was no between-group difference in recalled breathlessness intensity, 5.51 ([95% CI] 5.00 to 6.01) vs. 5.73 (5.27 to 6.20; p = 0.52) in controls, even though the intervention group had a significantly lower end breathlessness (mean difference 0.96; 0.24 to 1.67; p = 0.009).","[{'ForeName': 'Viktor', 'Initials': 'V', 'LastName': 'Elmberg', 'Affiliation': 'Department of Clinical Physiology, Blekinge Hospital, Karlskrona, Sweden.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Ekström', 'Affiliation': 'Department of Clinical Sciences Lund, Respiratory Medicine and Allergology, Faculty of Medicine, Lund University, Lund, Sweden.'}]",PloS one,['10.1371/journal.pone.0238937']
2736,32918964,Seven-Year Outcomes of Uveitic Macular Edema: The Multicenter Uveitis Steroid Treatment Trial and Follow-up Study Results.,"PURPOSE


To evaluate the long-term outcomes of uveitic macular edema (ME).
DESIGN


Longitudinal follow-up of a cohort of participants in a randomized clinical trial.
PARTICIPANTS


A total of 248 eyes of 177 participants with uveitic ME enrolled in the Multicenter Uveitis Steroid Treatment (MUST) Trial and Follow-up Study.
METHODS


OCT measurements, taken at baseline and annually, were graded by reading center graders masked to clinical data. Macular edema was defined as a center macular thickness (CMT) ≥240 μm on time-domain OCT or time-domain OCT equivalent. Resolution of ME was defined as normalization of macular thickness on OCT. Relapse of ME was defined as increase in macular thickness to ≥240 μm in an eye that previously had resolution. Visual acuity was measured at each visit with logarithmic visual acuity charts.
MAIN OUTCOME MEASURES


Resolution and relapse of ME. Visual acuity.
RESULTS


Among 227 eyes with ME followed ≥1 year, the cumulative percent of eyes with ME resolving at any point during 7 years was 94% (95% confidence interval [CI], 89-97). Epiretinal membranes on OCT were associated with a lower likelihood of ME resolution (hazard ratio [HR], 0.74; 95% CI, 0.55-1.01; P = 0.05). Among 177 eyes with resolved ME, the cumulative percent with relapse within 7 years was 43% (95% CI, 32-51). Eyes in which ME resolved gained a mean of 6.24 letters (95% CI, 4.40-8.09; P < 0.001) compared with eyes that remained free from ME during the 1-year follow-up intervals, whereas eyes in which ME did not resolve experienced no gain in vision (mean change -1.30 letters; 95% CI, -2.70 to 0.09; P = 0.065), and eyes that developed ME during the year (incident or relapsed) experienced a mean loss of -8.65 letters (95% CI, -11.5 to -5.84, P < 0.001).
CONCLUSIONS


Given sufficient time and treatment, nearly all uveitic ME resolves, but episodes of relapse were common. Visual acuity results were better among eyes with resolved ME, suggesting that control of inflammation and resolution of ME might be visually relevant treatment targets.",2020,"Epiretinal membranes on OCT were associated with a lower likelihood of macular edema resolution (hazard ratio [HR] 0.74; 95% CI 0.55, 1.01; P=0.05).","[' 248 eyes of 177 participants with uveitic macular edema enrolled in the Multicenter Uveitis Steroid Treatment Trial and Follow-up Study', '177 eyes with', '227 eyes with macular edema']","['Uveitis Steroid Treatment (MUST', 'Optical coherence tomography (OCT) measurements']","['macular thickness', 'Relapse of macular edema', 'Visual acuity results', 'gain in vision', 'uveitic macular edema', 'Visual acuity', 'macular edema', 'time-domain OCT or time-domain OCT equivalent', 'Resolution and relapse of macular edema', 'Resolution of macular edema', 'resolved macular edema', 'Macular edema', 'macular edema resolution']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0271051', 'cui_str': 'Macular retinal edema'}, {'cui': 'C0042164', 'cui_str': 'Uveitis'}, {'cui': 'C0149783', 'cui_str': 'Administration of steroid'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0016441', 'cui_str': 'Followup Studies'}]","[{'cui': 'C0042164', 'cui_str': 'Uveitis'}, {'cui': 'C0149783', 'cui_str': 'Administration of steroid'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]","[{'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0271051', 'cui_str': 'Macular retinal edema'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C3714811', 'cui_str': 'Resolved'}]",177.0,0.0526427,"Epiretinal membranes on OCT were associated with a lower likelihood of macular edema resolution (hazard ratio [HR] 0.74; 95% CI 0.55, 1.01; P=0.05).","[{'ForeName': 'Oren', 'Initials': 'O', 'LastName': 'Tomkins-Netzer', 'Affiliation': 'Institute of Ophthalmology, University College London, and Moorfields Eye Hospital, London, United Kingdom; Department of Ophthalmology, Lady Davis Carmel Medical Center, Ruth and Bruch Rappaport Faculty of Medicine, Technion - Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Lightman', 'Affiliation': 'Institute of Ophthalmology, University College London, and Moorfields Eye Hospital, London, United Kingdom.'}, {'ForeName': 'Alyce E', 'Initials': 'AE', 'LastName': 'Burke', 'Affiliation': 'Center for Clinical Trials and Evidence Synthesis, Department of Epidemiology, The Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Sugar', 'Affiliation': 'Center for Clinical Trials and Evidence Synthesis, Department of Epidemiology, The Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland; Department of Biostatistics, The Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Lyndell L', 'Initials': 'LL', 'LastName': 'Lim', 'Affiliation': 'Department of Ophthalmology, Royal Victorian Eye and Ear Hospital, East Melbourne, Australia.'}, {'ForeName': 'Glenn J', 'Initials': 'GJ', 'LastName': 'Jaffe', 'Affiliation': 'Department of Ophthalmology, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Michael M', 'Initials': 'MM', 'LastName': 'Altaweel', 'Affiliation': 'Department of Ophthalmology and Reading Center, University of Wisconsin, Madison, School of Medicine and Public Health, Madison, Wisconsin.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Kempen', 'Affiliation': 'Department of Ophthalmology Harvard Medical School and Massachusetts Eye and Ear Infirmary, Boston, Massachusetts; MCM Eye Unit, Myung Sung Christian Medical Center General Hospital and Medical School, Addis Ababa, Ethiopia.'}, {'ForeName': 'Janet T', 'Initials': 'JT', 'LastName': 'Holbrook', 'Affiliation': 'Center for Clinical Trials and Evidence Synthesis, Department of Epidemiology, The Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Douglas A', 'Initials': 'DA', 'LastName': 'Jabs', 'Affiliation': 'Center for Clinical Trials and Evidence Synthesis, Department of Epidemiology, The Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland; Department of Ophthalmology, the Wilmer Eye Institute, the Johns Hopkins University School of Medicine, Baltimore, Maryland. Electronic address: djabs@jhmi.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Ophthalmology,['10.1016/j.ophtha.2020.08.035']
2737,32919015,The effect of 12-week resistance exercise training on serum levels of cellular aging process parameters in elderly men.,"BACKGROUND


Regular physical activity has a positive effect on the prevention of cellular aging. The present study investigated the effect of 12-week resistance training (RT) on serum levels of Sirtuin-1 (SIRT1), Sirtuin-3 (SIRT3), Sirtuin-6 (SIRT6), Peroxisome proliferator-activated receptor gamma coactivator 1-alpha (PGC1-α), and telomerase enzyme in elderly men.
METHODS


For this purpose, 30 elderly men (age 66.23 ± 0.57 years) were randomly divided into two groups: resistance training group (RET, n = 15) and control group (CTR, n = 15). Participants in RET performed RT protocols with intensity of 60% one-repetition maximum (3×/week, 4 sets of the six exercise circuits). Body composition, physical functioning and, blood samples were assessed before (pre-test) and after (post-test) a 12-week intervention.
RESULTS


The results showed that there was a significant increase in serum levels of SIRT1 (P = 0.001), SIRT3 (P = 0.001), SIRT6 (P = 0.02), PGC1-α (P = 0.001), and telomerase enzyme (P = 0.001) in RET. Also, we found a significant difference between the RET and CTR in serum levels of SIRT1 (P = 0.001), SIRT3 (P = 0.001), SIRT6 (P = 0.037), PGC1-α (P = 0.007), and telomerase enzyme (P = 0.001).
CONCLUSIONS


12-Week RT increased the levels of proteins associated with the biological aging process in elderly men. It seems that the RT may have beneficial effects on cellular senescence and also improved impaired mitochondrial protein and enzymatic functional induced aging.",2020,"The results showed that there was a significant increase in serum levels of SIRT1 (P = 0.001), SIRT3 (P = 0.001), SIRT6 (P = 0.02), PGC1-α (P = 0.001), and telomerase enzyme (P = 0.001) in RET.","['elderly men', '30 elderly men (age 66.23\u202f±\u202f0.57\u202fyears']","['12-week resistance training (RT', 'resistance exercise training', 'resistance training group (RET, n\u202f=\u202f15) and control group (CTR']","['PGC1-α', 'RET and CTR in serum levels of SIRT1', 'SIRT6', 'telomerase enzyme', 'serum levels of Sirtuin-1 (SIRT1), Sirtuin-3 (SIRT3), Sirtuin-6 (SIRT6), Peroxisome proliferator-activated receptor gamma coactivator 1-alpha (PGC1-α), and telomerase enzyme', 'SIRT3', 'serum levels of SIRT1', 'Body composition, physical functioning and, blood samples']","[{'cui': 'C0524337', 'cui_str': 'Elderly man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0389252', 'cui_str': 'RET protein, human'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0389252', 'cui_str': 'RET protein, human'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2720167', 'cui_str': 'Sirt1'}, {'cui': 'C1136177', 'cui_str': 'Silent Mating Type Information Regulator 2-like Proteins'}, {'cui': 'C0087071', 'cui_str': 'Telomerase Reverse Transcriptase'}, {'cui': 'C0014442', 'cui_str': 'Enzyme'}, {'cui': 'C2720169', 'cui_str': 'Sirt3'}, {'cui': 'C1452082', 'cui_str': 'PPARGC1A protein, human'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}]",30.0,0.0157346,"The results showed that there was a significant increase in serum levels of SIRT1 (P = 0.001), SIRT3 (P = 0.001), SIRT6 (P = 0.02), PGC1-α (P = 0.001), and telomerase enzyme (P = 0.001) in RET.","[{'ForeName': 'Babak', 'Initials': 'B', 'LastName': 'Hooshmand-Moghadam', 'Affiliation': 'Department of Exercise Physiology, Ferdowsi University of Mashhad, Mashhad, Iran; Department of Exercise Physiology, University of Tehran, Tehran, Iran.'}, {'ForeName': 'Mozhgan', 'Initials': 'M', 'LastName': 'Eskandari', 'Affiliation': 'Department of Exercise Physiology, University of Birjand, Birjand, Iran.'}, {'ForeName': 'Fateme', 'Initials': 'F', 'LastName': 'Golestani', 'Affiliation': 'Department of Exercise Physiology, University of Birjand, Birjand, Iran.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Rezae', 'Affiliation': 'Department of Exercise Physiology, Ferdowsi University of Mashhad, Mashhad, Iran.'}, {'ForeName': 'Nahid', 'Initials': 'N', 'LastName': 'Mahmoudi', 'Affiliation': 'Department of Exercise Physiology, Ferdowsi University of Mashhad, Mashhad, Iran.'}, {'ForeName': 'Abbas Ali', 'Initials': 'AA', 'LastName': 'Gaeini', 'Affiliation': 'Department of Exercise Physiology, University of Tehran, Tehran, Iran. Electronic address: aagaeini@ut.ac.ir.'}]",Experimental gerontology,['10.1016/j.exger.2020.111090']
2738,32920646,"Erratum to: ""Safety and Efficacy of Oral Octreotide in Acromegaly: Results of a Multicenter Phase III Trial"".",,2020,,['Acromegaly'],['Oral Octreotide'],[],"[{'cui': 'C0001206', 'cui_str': 'Acromegaly'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0028833', 'cui_str': 'Octreotide'}]",[],,0.018058,,[],The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa637']
2739,32921065,A clinical study on the treatment of granulomatous lobular mastitis by the external application of the internal pus-expelling decoction and operation.,"BACKGROUND


The objective of this study was to evaluate the clinical efficacy of the external application of internal expulsion pus-expelling decoction (IEPED) combined with surgery in the treatment of granulomatous lobular mastitis (GLM).
METHODS


A total of 110 patients in our hospital with sepsis GLM were randomly divided into two groups: treatment group (n=60, the wound was treated with IEPED) and control group (n=50, the wound was not treated with IEPED). We assessed the recurrence, contra lateral breast form, and aesthetic evaluation of the patients in the two groups.
RESULTS


The total effective rates in the patients in the treatment group and the control group were 90% and 68%, respectively, after the preoperative pretreatment and before radical surgery (P<0.05). After 10 days of receiving the debridement treatment, the two groups were compared in term of physical signs scores and the difference was statistically significant (P<0.05). Within one year of the regular follow-up after treatment, 0 case recurred in the treatment group and 1 case recurred in the control group (P>0.05). In the treatment group, 30 cases showed excellent results in the aesthetic evaluation of breast appearance, 18 cases were good, and the overall excellent and good rate was up to 80%. In the control group, 12 cases showed excellent results and 16 cases showed good results, with the overall excellent and good rate reaching 56% (P<0.05).
CONCLUSIONS


In patients with abscess debridement of GLM, the external application of IEPED can significantly reduce the primary lesion of patients with abscess GLM, reduce the surgical resection area, and maximize the preservation of the patients' breast appearance.",2020,"In patients with abscess debridement of GLM, the external application of IEPED can significantly reduce the primary lesion of patients with abscess GLM, reduce the surgical resection area, and maximize the preservation of the patients' breast appearance.","['granulomatous lobular mastitis (GLM', '110 patients in our hospital with sepsis GLM']","['GLM', 'IEPED) and control group (n=50, the wound was not treated with IEPED', 'internal pus-expelling decoction and operation', 'internal expulsion pus-expelling decoction (IEPED) combined with surgery']","['recurrence, contra lateral breast form, and aesthetic evaluation', 'aesthetic evaluation of breast appearance', 'total effective rates', 'overall excellent and good rate']","[{'cui': 'C0439667', 'cui_str': 'Granulomatous'}, {'cui': 'C0205417', 'cui_str': 'Lobular'}, {'cui': 'C0024894', 'cui_str': 'Mastitis'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0439667', 'cui_str': 'Granulomatous'}, {'cui': 'C0205417', 'cui_str': 'Lobular'}, {'cui': 'C0024894', 'cui_str': 'Mastitis'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C1293107', 'cui_str': 'Expulsion'}, {'cui': 'C0034161', 'cui_str': 'Pus'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C1286083', 'cui_str': 'Form of breast'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C1286082', 'cui_str': 'Appearance of breast'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1961136', 'cui_str': 'Excellent'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}]",18.0,0.0159327,"In patients with abscess debridement of GLM, the external application of IEPED can significantly reduce the primary lesion of patients with abscess GLM, reduce the surgical resection area, and maximize the preservation of the patients' breast appearance.","[{'ForeName': 'Peng-Zhou', 'Initials': 'PZ', 'LastName': 'Liu', 'Affiliation': 'Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Xiao-Guang', 'Initials': 'XG', 'LastName': 'Shi', 'Affiliation': 'Department of Galactophore Dongzhimen Hospital of Beijing University of Chinese Medicine, Beijing, China. shixgtcm915@163.com.'}, {'ForeName': 'Xi-Meng', 'Initials': 'XM', 'LastName': 'Zuo', 'Affiliation': 'Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Lai', 'Affiliation': 'Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Ze', 'Initials': 'Z', 'LastName': 'Zhao', 'Affiliation': 'Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Zhen-Rui', 'Initials': 'ZR', 'LastName': 'Yang', 'Affiliation': 'Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Jie-Li', 'Initials': 'JL', 'LastName': 'Liu', 'Affiliation': 'Beijing University of Chinese Medicine, Beijing, China.'}]",Annals of palliative medicine,['10.21037/apm-19-684']
2740,32921090,Efficacy of self-heating calf sleeves for preventing deep vein thrombosis in lung cancer patients who undergo video-assisted thoracoscopic surgery lobectomy.,"BACKGROUND


Deep vein thrombosis (DVT) poses a considerable perioperative risk in patients who undergo surgical procedures. This study set out to determine the efficacy of self-heating calf sleeves (SHCSs) in preventing postoperative DVT in lung cancer patients undergoing VATS lobectomy.
METHODS


This study included 557 participants who underwent video-assisted thoracoscopic surgery (VATS) lobectomy between June, 2018 and June, 2019. The participants were randomly divided into two groups: the SHCS group and the control group. SHCS was applied to the patients intraoperatively. Each patient was subjected to Doppler ultrasound and D-dimer examination preoperatively and postoperatively. Signs and symptoms of DVT were monitored daily. Incidences of DVT were compared between the two groups.
RESULTS


Based on Color Doppler ultrasonography performed on day 2 after surgery, 42 of the 276 patients (15.20%) in the control group developed DVT, compared to 12 out of 281 patients (4.27%) in the SHCS group. There was significant difference in the incidence of DVT between the two groups (P<0.0001). The use of SHCSs significantly enhanced venous blood flow compared to when no mechanical prophylaxis was used (P<0.001). No significant difference in plasma D-dimer level was observed between the two groups. No SHCS-related complications occurred in the study.
CONCLUSIONS


This study demonstrate that SHCSs are a satisfactory form of DVT prophylaxis method that can improve venous blood flow and thus alleviate venous stasis in the lower extremities. SHCSs offer a simple, inexpensive, and generally complication-free prophylactic method for lung cancer patients undergoing VATS lobectomy.
TRIAL REGISTRATION


ChiCTR1900022043.",2020,The use of SHCSs significantly enhanced venous blood flow compared to when no mechanical prophylaxis was used (P<0.001).,"['patients who undergo surgical procedures', '557 participants who underwent', 'lung cancer patients undergoing VATS lobectomy', 'lung cancer patients who undergo video-assisted thoracoscopic surgery lobectomy', 'between June, 2018 and June, 2019']","['SHCSs', 'self-heating calf sleeves (SHCSs', 'video-assisted thoracoscopic surgery (VATS) lobectomy', 'SHCS', 'self-heating calf sleeves']","['Signs and symptoms of DVT', 'deep vein thrombosis', 'plasma D-dimer level', 'Incidences of DVT', 'incidence of DVT', 'SHCS-related complications', 'venous blood flow']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C4520228', 'cui_str': 'Thoracoscopic surgical lobectomy using video-assisted guidance'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0018851', 'cui_str': 'Heating'}, {'cui': 'C0230445', 'cui_str': 'Structure of calf of leg'}, {'cui': 'C0183336', 'cui_str': 'Sleeve'}, {'cui': 'C0752151', 'cui_str': 'Surgery, Thoracic, Video-Assisted'}, {'cui': 'C0023928', 'cui_str': 'Lobectomy'}]","[{'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0060323', 'cui_str': 'D-dimer'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0229667', 'cui_str': 'Venous blood'}]",557.0,0.0169138,The use of SHCSs significantly enhanced venous blood flow compared to when no mechanical prophylaxis was used (P<0.001).,"[{'ForeName': 'Shenghua', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Department of Operating Room, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Wenwen', 'Initials': 'W', 'LastName': 'Xu', 'Affiliation': 'Department of Operating Room, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Saiqi', 'Initials': 'S', 'LastName': 'Song', 'Affiliation': 'Department of Operating Room, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, China. zhaoyunfeng518@126.com.'}, {'ForeName': 'Xiaojun', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Operating Room, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, China. woailuyue0701@126.com.'}]",Annals of palliative medicine,['10.21037/apm-20-1165']
2741,32921096,"Efficacy and safety of HX 110-A and HX 110-B in promoting respiratory health: protocol for an 8-week, randomized, double-blind, parallel group, placebo-controlled trial.","BACKGROUND


HX110-A and HX110-B are compound extracts based on radix adenophorae and rhizoma dioscoreae, respectively, which have anti-inflammatory activity. There are limited data on whether they may help improve respiratory conditions including lung function. Therefore, in this trial, we will evaluate the effectiveness and safety of the use of HX110-A and HX110-B for the treatment of respiratory health in adults with mild respiratory symptoms.
METHODS


This will be an 8-week, randomized, double-blind, parallel group, placebo-controlled trial with three arms. Adults more than 40 years old with persistent respiratory symptoms will be enrolled. Patients with definite respiratory disease or with a history of recent intake of antioxidants or anti-inflammatory agents will be excluded. Study subjects will be assigned at a 1:1:1 ratio into the following three arms: controls, experimental group 1 (HX110-A), and experimental group 2 (HX110-B). Control or experimental foods will be administered for 8 weeks, and follow-up will be up to 12 weeks. The primary outcome will be total antioxidant capacity. Secondary outcomes will be inflammatory indexes, respiratory symptoms, lung function, quality of life, and fatigue level. Safety outcomes will be assessed by monitoring adverse events and vital signs, and through clinical pathology tests.
RESULTS


This trial will reveal the effectiveness and safety of HX110-A and/or HX110-B for medical purposes in adults with respiratory symptoms. The results should clarify if active intake of specific foods with these functional compounds may promote respiratory health in adults without definite respiratory disease.
TRIAL REGISTRATION


Clinical Research Information Service, KCT0003614. Registered 12 May 2019 (Respectively registered, https://cris.nih.go.kr/cris/en/search/search_result_st01.jsp?seq=13364).",2020,This trial will reveal the effectiveness and safety of HX110-A and/or HX110-B for medical purposes in adults with respiratory symptoms.,"['adults with mild respiratory symptoms', 'Adults more than 40 years old with persistent respiratory symptoms', 'adults without definite respiratory disease', 'adults with respiratory symptoms', 'Patients with definite respiratory disease or with a history of recent intake of antioxidants or anti-inflammatory agents']","['HX 110-A and HX 110-B', 'HX110-A and HX110-B', 'placebo', 'HX110-A and/or HX110-B']","['Efficacy and safety', 'monitoring adverse events and vital signs, and through clinical pathology tests', 'inflammatory indexes, respiratory symptoms, lung function, quality of life, and fatigue level', 'total antioxidant capacity']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0037090', 'cui_str': 'Respiratory symptom'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0439544', 'cui_str': 'Definite'}, {'cui': 'C0035204', 'cui_str': 'Disorder of respiratory system'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}]","[{'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0030667', 'cui_str': 'Clinical Pathology'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0037090', 'cui_str': 'Respiratory symptom'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C2586108', 'cui_str': 'Level of fatigue'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}]",,0.58787,This trial will reveal the effectiveness and safety of HX110-A and/or HX110-B for medical purposes in adults with respiratory symptoms.,"[{'ForeName': 'Jung-Kyu', 'Initials': 'JK', 'LastName': 'Lee', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul Metropolitan Government-Seoul National University Boramae Medical Center, Republic of Korea.'}, {'ForeName': 'Bumjo', 'Initials': 'B', 'LastName': 'Oh', 'Affiliation': 'Department of Family Medicine, Seoul Metropolitan Government-Seoul National University Boramae Medical Center, Republic of Korea.'}, {'ForeName': 'Hyun Woo', 'Initials': 'HW', 'LastName': 'Lee', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul Metropolitan Government-Seoul National University Boramae Medical Center, Republic of Korea.'}, {'ForeName': 'Seo-Young', 'Initials': 'SY', 'LastName': 'Yoon', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul Metropolitan Government-Seoul National University Boramae Medical Center, Republic of Korea.'}, {'ForeName': 'Tae Yun', 'Initials': 'TY', 'LastName': 'Park', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul Metropolitan Government-Seoul National University Boramae Medical Center, Republic of Korea.'}, {'ForeName': 'Eun Young', 'Initials': 'EY', 'LastName': 'Heo', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul Metropolitan Government-Seoul National University Boramae Medical Center, Republic of Korea.'}, {'ForeName': 'Deog Kyeom', 'Initials': 'DK', 'LastName': 'Kim', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul Metropolitan Government-Seoul National University Boramae Medical Center, Republic of Korea. kimdkmd@gmail.com.'}]",Annals of palliative medicine,['10.21037/apm-20-1214']
2742,32919703,mTOR - Mediated protein synthesis by inhibiting protein catabolism in Chinese perch (Siniperca chuatsi).,"Activation of the mechanistic target of rapamycin (mTOR) pathway is known to promote protein synthesis by enhancing mRNA translation. However, there have been few literatures on the effect of mTOR on protein metabolism in non-mammals. The main source of ammonia in fish comes from protein catabolism. The key step of protein catabolism involves the deamination and/or transamination of amino acids. This study is aimed to explore the mechanism underlying mTOR pathway influencing protein retention from the perspective of protein catabolism. Chinese perch were fasted for 24 h and divided into 4 groups randomly before intracerebroventricular (ICV) injection: (1) control group for leucine; (2) leucine group; (3) control group for leucine and rapamycin; (4) leucine and rapamycin group. Food intake was equivalent between each control and treatment groups at each time point (0.5, 4, 12 and 24 h post-injection). Ammonia-N excretion rate, blood glucose, S6 phosphorylation level, and expression of relative genes of protein catabolism (GDH, AMPD, AST, ALT) were determined. The results indicated that the pS6 level was increased, and that the ammonia-N excretion rate, blood glucose, and mRNA level of protein catabolism genes (GDH and AMPD) were significantly decreased after injection with leucine, while those changes were reversed after injection with leucine and rapamycin. Our study not only reveals the mechanism by which mTOR mediates protein synthesis by inhibiting protein catabolism in Chinese perch, but also provides reference for improving the utilization of feed protein.",2020,"Food intake was equivalent between each control and treatment groups at each time point (0.5, 4, 12 and 24 h post-injection).",[],"['intracerebroventricular (ICV) injection: (1) control group for leucine; (2) leucine group; (3) control group for leucine and rapamycin; (4) leucine and rapamycin group', 'leucine and rapamycin', 'rapamycin']","['ammonia-N excretion rate, blood glucose, and mRNA level of protein catabolism genes (GDH and AMPD', 'pS6 level', 'Food intake', 'Ammonia-N excretion rate, blood glucose, S6 phosphorylation level, and expression of relative genes of protein catabolism (GDH, AMPD, AST, ALT']",[],"[{'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0023401', 'cui_str': 'Leucine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}]","[{'cui': 'C0002607', 'cui_str': 'Ammonia'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0543484', 'cui_str': 'catabolism'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0031715', 'cui_str': 'Phosphorylation'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}]",,0.0135621,"Food intake was equivalent between each control and treatment groups at each time point (0.5, 4, 12 and 24 h post-injection).","[{'ForeName': 'Jiao', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'College of Fisheries, Chinese Perch Research Center, Huazhong Agricultural University, Wuhan, 430070, China; Key Lab of Freshwater Animal Breeding, Ministry of Agriculture and Rural Affair/ Hubei Engineering Technology Research Center for Fish Breeding and Healthy Aquaculture, Wuhan, 430070, China.'}, {'ForeName': 'Yanpeng', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'College of Fisheries, Chinese Perch Research Center, Huazhong Agricultural University, Wuhan, 430070, China; Key Lab of Freshwater Animal Breeding, Ministry of Agriculture and Rural Affair/ Hubei Engineering Technology Research Center for Fish Breeding and Healthy Aquaculture, Wuhan, 430070, China.'}, {'ForeName': 'Xu-Fang', 'Initials': 'XF', 'LastName': 'Liang', 'Affiliation': 'College of Fisheries, Chinese Perch Research Center, Huazhong Agricultural University, Wuhan, 430070, China; Key Lab of Freshwater Animal Breeding, Ministry of Agriculture and Rural Affair/ Hubei Engineering Technology Research Center for Fish Breeding and Healthy Aquaculture, Wuhan, 430070, China. Electronic address: xufang_liang@hotmail.com.'}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'He', 'Affiliation': 'College of Fisheries, Chinese Perch Research Center, Huazhong Agricultural University, Wuhan, 430070, China; Key Lab of Freshwater Animal Breeding, Ministry of Agriculture and Rural Affair/ Hubei Engineering Technology Research Center for Fish Breeding and Healthy Aquaculture, Wuhan, 430070, China.'}, {'ForeName': 'Shulin', 'Initials': 'S', 'LastName': 'Tang', 'Affiliation': 'College of Fisheries, Chinese Perch Research Center, Huazhong Agricultural University, Wuhan, 430070, China; Key Lab of Freshwater Animal Breeding, Ministry of Agriculture and Rural Affair/ Hubei Engineering Technology Research Center for Fish Breeding and Healthy Aquaculture, Wuhan, 430070, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'College of Fisheries, Chinese Perch Research Center, Huazhong Agricultural University, Wuhan, 430070, China; Key Lab of Freshwater Animal Breeding, Ministry of Agriculture and Rural Affair/ Hubei Engineering Technology Research Center for Fish Breeding and Healthy Aquaculture, Wuhan, 430070, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'College of Fisheries, Chinese Perch Research Center, Huazhong Agricultural University, Wuhan, 430070, China; Key Lab of Freshwater Animal Breeding, Ministry of Agriculture and Rural Affair/ Hubei Engineering Technology Research Center for Fish Breeding and Healthy Aquaculture, Wuhan, 430070, China.'}]",Biochemical and biophysical research communications,['10.1016/j.bbrc.2020.08.107']
2743,32928607,Establishment and validation of a model for brain injury state evaluation and prognosis prediction.,"PURPOSE


Traumatic brain injury (TBI) is one of the leading causes of disability and death in modern times, whose evaluation and prognosis prediction have been one of the most critical issues in TBI management. However, the existed models for the abovementioned purposes were defective to varying degrees. This study aims to establish an ideal brain injury state clinical prediction model (BISCPM).
METHODS


This study was a retrospective design. The six-month outcomes of patients were selected as the end point event. BISCPM was established by using the split-sample technology, and externally validated via different tests of comparison between the observed and predicted six-month mortality in validating group. TBI patients admitted from July 2006 to June 2012 were recruited and randomly divided into establishing model group and validating model group. Twenty-one scoring indicators were included in BISCPM and divided into three parts, A, B, and C. Part A included movement, pupillary reflex and diameter, CT parameters, and secondary brain insult factors, etc. Part B was age and part C was medical history of the patients. The total score of part A, B and C was final score of BISCPM.
RESULTS


Altogether 1156 TBI patients were included with 578 cases in each group. The score of BISCPM from validating group ranged from 2.75 to 31.94, averaging 13.64 ± 5.59. There was not statistical difference between observed and predicted mortality for validating group. The discrimination validation showed that the BISCPM is superior to international mission for prognosis and analysis of clinical trials (IMPACT) lab model.
CONCLUSION


BISCPM is an effective model for state evaluation and prognosis prediction of TBI patients. The use of BISCPM could be of great significance for decision-making in management of TBI.",2020,"The discrimination validation showed that the BISCPM is superior to international mission for prognosis and analysis of clinical trials (IMPACT) lab model.
","['TBI patients', 'Altogether 1156 TBI patients were included with 578 cases in each group', 'TBI patients admitted from July 2006 to June 2012', 'Traumatic brain injury (TBI']",['BISCPM'],"['score of BISCPM', 'total score of part A, B and C']","[{'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]","[{'cui': 'C0270611', 'cui_str': 'Brain injury'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0270611', 'cui_str': 'Brain injury'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",1156.0,0.0227368,"The discrimination validation showed that the BISCPM is superior to international mission for prognosis and analysis of clinical trials (IMPACT) lab model.
","[{'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ""Department of Neurosurgery, Xijing Hospital, Fourth Military Medical University, Xi'an 710032, China.""}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Lü', 'Affiliation': ""Neurosurgical Institute of PLA, Xi'an 710032, China.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Department of Digestive Surgery, Xijing Hospital, Fourth Military Medical University, Xi'an 710032, China.""}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Wan', 'Affiliation': ""Department of Statistics, School of Preventive Medicine, Fourth Military Medical University, Xi'an 710032, China.""}, {'ForeName': 'Shu-Hui', 'Initials': 'SH', 'LastName': 'Dai', 'Affiliation': ""Department of Neurosurgery, Xijing Hospital, Fourth Military Medical University, Xi'an 710032, China.""}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': ""Department of Neurosurgery, Xijing Hospital, Fourth Military Medical University, Xi'an 710032, China.""}, {'ForeName': 'Xue-An', 'Initials': 'XA', 'LastName': 'Hu', 'Affiliation': ""Department of Neurosurgery, Xijing Hospital, Fourth Military Medical University, Xi'an 710032, China.""}, {'ForeName': 'Xiao-Fan', 'Initials': 'XF', 'LastName': 'Jiang', 'Affiliation': ""Department of Neurosurgery, Xijing Hospital, Fourth Military Medical University, Xi'an 710032, China.""}, {'ForeName': 'Zhou', 'Initials': 'Z', 'LastName': 'Fei', 'Affiliation': ""Department of Neurosurgery, Xijing Hospital, Fourth Military Medical University, Xi'an 710032, China. Electronic address: xjswlixia@sina.com.""}]",Chinese journal of traumatology = Zhonghua chuang shang za zhi,['10.1016/j.cjtee.2020.08.006']
2744,32924954,A Mobile Gaming Intervention for Persons on Pre-Exposure Prophylaxis: Protocol for Intervention Development and Randomized Controlled Trial.,"BACKGROUND


In the United States, young minority men who have sex with men (MSM) are the most likely to become infected with HIV. Pre-exposure prophylaxis (PrEP) is an efficacious and promising prevention strategy. However, PrEP's safety and effectiveness can be greatly compromised by suboptimal adherence to treatment. To maximize the positive impact of PrEP, it is necessary to combine its prescription with cost-effective behavioral interventions that promote adherence and decrease HIV risk behaviors. In this project, we developed a theoretically informed app/gaming intervention to engage young MSM in learning information, practicing behaviors, and improving motivation for HIV preventative behaviors and PrEP adherence.
OBJECTIVE


The goal of this project was to develop and test a cutting-edge, engaging, and entertaining app/gaming intervention for improving adherence to PrEP and building HIV prevention knowledge, skills, and behavior.
METHODS


This study was conducted in two phases. In the developmental phase, we conducted qualitative interviews with young MSM (n=20) to guide the development of the gaming intervention. In the randomized controlled trial, we tested the preliminary efficacy of the gaming intervention compared to a comparison condition among young MSM. Subjects were recruited from the University of Mississippi Medical Center HIV/STI testing clinics (n=60).
RESULTS


Institutional review board approval was received in February 2015. Research activities began in June 2015 and are still ongoing.
CONCLUSIONS


This app/gaming intervention aimed to improve PrEP adherence and HIV preventative behaviors in young MSM. Engaging young MSM in learning information, practicing behaviors, and improving motivation for increased adherence to PrEP has the potential to decrease HIV seroconversion. It is important to develop interventions that are enjoyable, engaging, and easily incorporated into clinical settings.
TRIAL REGISTRATION


ClinicalTrials.gov RCT02611362; https://tinyurl.com/y65gkuwr.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/18640.",2020,"Engaging young MSM in learning information, practicing behaviors, and improving motivation for increased adherence to PrEP has the potential to decrease HIV seroconversion.","['Subjects were recruited from the University of Mississippi Medical Center HIV/STI testing clinics (n=60', 'young minority men who have sex with men (MSM', 'young MSM']","['Mobile Gaming Intervention', 'cutting-edge, engaging, and entertaining app/gaming intervention', 'gaming intervention']","['PrEP adherence and HIV preventative behaviors', 'HIV risk behaviors']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0026221', 'cui_str': 'Mississippi'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0036916', 'cui_str': 'Sexually transmitted infectious disease'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0000925', 'cui_str': 'Incised wound'}, {'cui': 'C0205154', 'cui_str': 'Along edge'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}]","[{'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}]",,0.0907411,"Engaging young MSM in learning information, practicing behaviors, and improving motivation for increased adherence to PrEP has the potential to decrease HIV seroconversion.","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Whiteley', 'Affiliation': 'Department of Psychiatry and Human Behavior, Warren Alpert Medical School, Brown University, Providence, RI, United States.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Olsen', 'Affiliation': 'Department of Psychiatry and Human Behavior, Warren Alpert Medical School, Brown University, Providence, RI, United States.'}, {'ForeName': 'Leandro', 'Initials': 'L', 'LastName': 'Mena', 'Affiliation': 'Department of Population Health Science, University of Mississippi Medical Center, Jackson, MS, United States.'}, {'ForeName': 'Kayla', 'Initials': 'K', 'LastName': 'Haubrick', 'Affiliation': 'Department of Psychiatry, Rhode Island Hospital, Providence, RI, United States.'}, {'ForeName': 'Lacey', 'Initials': 'L', 'LastName': 'Craker', 'Affiliation': 'Department of Psychiatry, Rhode Island Hospital, Providence, RI, United States.'}, {'ForeName': 'Dylan', 'Initials': 'D', 'LastName': 'Hershkowitz', 'Affiliation': 'Department of Psychiatry and Human Behavior, Warren Alpert Medical School, Brown University, Providence, RI, United States.'}, {'ForeName': 'Larry K', 'Initials': 'LK', 'LastName': 'Brown', 'Affiliation': 'Department of Psychiatry and Human Behavior, Warren Alpert Medical School, Brown University, Providence, RI, United States.'}]",JMIR research protocols,['10.2196/18640']
2745,32871870,Celiac disease serology and gut microbiome following protein pump inhibitor treatment.,"BACKGROUND


Celiac disease is an autoimmune enteropathy characterized by an aberrant immune response to ingested gluten in genetically predisposed individuals. Studies have pointed to a rising prevalence of celiac disease in recent decades. Changes in diet and use of medication that may impact the gut microbiome have been suggested as potential contributors. Exposure to protein pump inhibitors (PPIs) was recently found to be associated with an increased risk for subsequent diagnosis of celiac disease. We aimed to investigate potential mechanisms for this link by examining the relationship between PPI use and gluten-related immune responses in the context of changes in gut microbiome.
METHODS


We performed a post hoc analysis of blood and fecal samples from a recent randomized trial in order to assess the potential association between PPI use and development of celiac disease serology in conjunction with alterations in gastrointestinal microbial composition. The study included 12 healthy participants who were administered a PPI (Omeprazole; 40 mg twice daily) for 4 or 8 weeks.
RESULTS


The analysis did not reveal an overall significant change in levels of serologic markers of celiac disease for the study cohort in response to PPI treatment. However, one individual developed a marked increase in the celiac disease-specific autoantibody response to transglutaminase 2 in conjunction with enhanced immune reactivity to gluten during the trial. Genotyping revealed positivity for the celiac disease-associated HLA-DQ2 and -DQ8 alleles. Furthermore, the observed elevation in antibody responses was closely associated with a sharp increase in fecal abundance of bacteria of the order Actinomycetales.
CONCLUSIONS


The results of this exploratory analysis support further investigation of molecular mechanisms involved in the contribution of PPIs to celiac disease risk through the potential enhancement of gluten immunopathology and changes in gut microbial population.",2020,The analysis did not reveal an overall significant change in levels of serologic markers of celiac disease for the study cohort in response to PPI treatment.,['12 healthy participants who were administered a'],"['protein pump inhibitors (PPIs', 'PPI (Omeprazole']","['levels of serologic markers of celiac disease', 'celiac disease-specific autoantibody response', 'fecal abundance of bacteria of the order Actinomycetales']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0028978', 'cui_str': 'Omeprazole'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205473', 'cui_str': 'Serologic'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0007570', 'cui_str': 'Celiac disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0235914', 'cui_str': 'Autoantibody response'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0001254', 'cui_str': 'Actinomycetales'}]",12.0,0.0353551,The analysis did not reveal an overall significant change in levels of serologic markers of celiac disease for the study cohort in response to PPI treatment.,"[{'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Jang', 'Affiliation': 'Department of Medicine.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Lebwohl', 'Affiliation': 'Department of Medicine.'}, {'ForeName': 'Julian A', 'Initials': 'JA', 'LastName': 'Abrams', 'Affiliation': 'Department of Medicine.'}, {'ForeName': 'Peter H R', 'Initials': 'PHR', 'LastName': 'Green', 'Affiliation': 'Department of Medicine.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Freedberg', 'Affiliation': 'Department of Medicine.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Alaedini', 'Affiliation': 'Department of Medicine.'}]",Medicine,['10.1097/MD.0000000000021488']
2746,32927895,Eating Fast Has a Significant Impact on Glycemic Excursion in Healthy Women: Randomized Controlled Cross-Over Trial.,"Epidemiological studies have shown that self-reported fast eating increases the risk of diabetes and obesity. Our aim was to evaluate the acute effect of fast eating on glycemic parameters through conducting a randomized controlled cross-over study with young healthy women. Nineteen healthy women wore a flash glucose monitoring system for 6 days. Each participant consumed identical test meals with a different eating speed of fast eating (10 min) or slow eating (20 min) on the 4th or the 5th day. The daily glycemic parameters were compared between the 2 days. The mean amplitude of glycemic excursion (MAGE; fast eating 3.67 ± 0.31 vs. slow eating 2.67 ± 0.20 mmol/L,  p  < 0.01), incremental glucose peak (IGP; breakfast 2.30 ± 0.19 vs. 1.71 ± 0.12 mmol/L,  p  < 0.01, lunch 4.06 ± 0.33 vs. 3.13 ± 0.28 mmol/L,  p  < 0.01, dinner 3.87 ± 0.38 vs. 2.27 ± 0.27 mmol/L,  p  < 0.001), and incremental area under the curve for glucose of dinner 2 h (IAUC; 256 ± 30 vs. 128 ± 18 mmol/L × min,  p  < 0.001) for fast eating were all significantly higher than those for slow eating. The results suggest that fast eating is associated with higher glycemic excursion in healthy women.",2020,"p  < 0.001), and incremental area under the curve for glucose of dinner 2 h (IAUC; 256 ± 30 vs. 128 ± 18 mmol/L × min,  ","['Nineteen healthy women wore a', 'healthy women', 'Healthy Women', 'young healthy women']","['identical test meals with a different eating speed of fast eating (10 min) or slow eating', 'flash glucose monitoring system']","['glycemic excursion', 'daily glycemic parameters', 'fast eating', 'Glycemic Excursion', 'incremental glucose peak', 'mean amplitude of glycemic excursion']","[{'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0085635', 'cui_str': 'Photopsia'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",19.0,0.0534393,"p  < 0.001), and incremental area under the curve for glucose of dinner 2 h (IAUC; 256 ± 30 vs. 128 ± 18 mmol/L × min,  ","[{'ForeName': 'Yuuki', 'Initials': 'Y', 'LastName': 'Saito', 'Affiliation': ""Department of Food and Nutrition, Faculty of Home Economics, Kyoto Women's University, 35, Kitahiyoshi-cho, Imakumano, Higashiyama-ku, Kyoto 605-8501, Japan.""}, {'ForeName': 'Shizuo', 'Initials': 'S', 'LastName': 'Kajiyama', 'Affiliation': 'Kajiyama Clinic, Kyoto Gojyo Clinic Build. 20-1, Higasionnmaeda-cho, Nishinanajyo, Shimogyo-ku, Kyoto 600-8898, Japan.'}, {'ForeName': 'Ayasa', 'Initials': 'A', 'LastName': 'Nitta', 'Affiliation': ""Department of Food and Nutrition, Faculty of Home Economics, Kyoto Women's University, 35, Kitahiyoshi-cho, Imakumano, Higashiyama-ku, Kyoto 605-8501, Japan.""}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Miyawaki', 'Affiliation': ""Department of Food and Nutrition, Faculty of Home Economics, Kyoto Women's University, 35, Kitahiyoshi-cho, Imakumano, Higashiyama-ku, Kyoto 605-8501, Japan.""}, {'ForeName': 'Shinya', 'Initials': 'S', 'LastName': 'Matsumoto', 'Affiliation': ""Department of Food and Nutrition, Faculty of Home Economics, Kyoto Women's University, 35, Kitahiyoshi-cho, Imakumano, Higashiyama-ku, Kyoto 605-8501, Japan.""}, {'ForeName': 'Neiko', 'Initials': 'N', 'LastName': 'Ozasa', 'Affiliation': 'Graduate School of Medicine, Kyoto University, 54, Kawahara-cho, Syogoin, Sakyo-ku, Kyoto 606-8507, Japan.'}, {'ForeName': 'Shintaro', 'Initials': 'S', 'LastName': 'Kajiyama', 'Affiliation': 'Japanese Red Cross Kyoto Daini Hospital, 355-5, Kamanza, Marutamachi, Kamigyo-ku, Kyoto 602-8026, Japan.'}, {'ForeName': 'Yoshitaka', 'Initials': 'Y', 'LastName': 'Hashimoto', 'Affiliation': 'Graduate School of Medical Science, Kyoto Prefectural University of Medicine, 465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan.'}, {'ForeName': 'Michiaki', 'Initials': 'M', 'LastName': 'Fukui', 'Affiliation': 'Graduate School of Medical Science, Kyoto Prefectural University of Medicine, 465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan.'}, {'ForeName': 'Saeko', 'Initials': 'S', 'LastName': 'Imai', 'Affiliation': ""Department of Food and Nutrition, Faculty of Home Economics, Kyoto Women's University, 35, Kitahiyoshi-cho, Imakumano, Higashiyama-ku, Kyoto 605-8501, Japan.""}]",Nutrients,['10.3390/nu12092767']
2747,32936085,User Experience and Effects of an Individually Tailored Transdiagnostic Internet-Based and Mobile-Supported Intervention for Anxiety Disorders: Mixed-Methods Study.,"BACKGROUND


Internet interventions have been shown to be effective in treating anxiety disorders. Most interventions to date focus on single disorders and disregard potential comorbidities.
OBJECTIVE


The aim of this mixed-methods study was to investigate feasibility, user experience, and effects of a newly developed individually tailored transdiagnostic guided internet intervention for anxiety disorders.
METHODS


This study is an uncontrolled, within-group, baseline, postintervention pilot trial with an embedded qualitative and quantitative process and effect evaluation. In total, 49 adults with anxiety disorders (generalized anxiety disorder n=20, social phobia n=19, agoraphobia without panic n=12, panic with agoraphobia n=6, panic without agoraphobia n=4, subclinical depression n=41) received access to the 7-session intervention. We examined motivation and expectations, intervention use, user experience, impact, and modification requests. Qualitative data were assessed using semistructured interviews and analyzed by qualitative content analysis. Quantitative outcomes included symptom severity of anxiety and depression (Hamilton Anxiety Rating Scale [HAM-A], Quick Item Inventory of Depressive Symptomatology clinician rating [QIDS-C]), diagnostic status in clinical interviews (Mini International Neuropsychiatric Interview [MINI]), and web-based self-reports (Generalized Anxiety Disorder-7 [GAD-7], Center for Epidemiological Studies Depression Scale [CES-D], Beck Anxiety Inventory [BAI], Panic and Agoraphobia Scale [PAS], Social Phobia Scale [SPS], Patient Health Questionnaire-9 [PHQ-9]) at baseline and postassessment. Quantitative data was analyzed by comparing within-group means expressed as Cohen d.
RESULTS


Anxiety symptom severity (HAM-A d=1.19) and depressive symptoms (QIDS-C d=0.42) improved significantly, and 54% (21/39) no longer were diagnosed as having any anxiety disorder. The main positive effects were the general improvement of disease burden and attentiveness to feelings and risk situations while the main negative effects experienced were lack of change in disease burden and symptom deterioration. The most prevalent reasons for participation were the advantages of online treatment, symptom burden, and openness toward online treatment. Helpful factors included support, psychoeducation and practicing strategies in daily life; the main hindering factors were too little individualization and being overwhelmed by the content and pace.
CONCLUSIONS


The intervention was found to be feasible and results show preliminary data indicating potential efficacy for improving anxiety and depression. The next step should be the evaluation within a randomized controlled trial. Concerning intervention development, it was found that future interventions should emphasize individualization even more in order to further improve the fit to individual characteristics, preferences, and needs.",2020,"RESULTS


Anxiety symptom severity (HAM-A d=1.19) and depressive symptoms (QIDS-C d=0.42) improved significantly, and 54% (21/39) no longer were diagnosed as having any anxiety disorder.","['49 adults with anxiety disorders (generalized anxiety disorder n=20, social phobia n=19, agoraphobia without panic n=12, panic with agoraphobia n=6, panic without agoraphobia n=4, subclinical depression n=41) received']","['access to the 7-session intervention', 'Individually Tailored Transdiagnostic Internet-Based and Mobile-Supported Intervention']","['Anxiety symptom severity (HAM-A d=1.19) and depressive symptoms', 'symptom severity of anxiety and depression (Hamilton Anxiety Rating Scale [HAM-A], Quick Item Inventory of Depressive Symptomatology clinician rating [QIDS-C]), diagnostic status in clinical interviews (Mini International Neuropsychiatric Interview [MINI]), and web-based self-reports (Generalized Anxiety Disorder-7 [GAD-7], Center for Epidemiological Studies Depression Scale [CES-D], Beck Anxiety Inventory [BAI], Panic and Agoraphobia Scale [PAS], Social Phobia Scale [SPS], Patient Health Questionnaire-9', 'disease burden and attentiveness to feelings and risk situations', 'disease burden and symptom deterioration', 'anxiety and depression']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031572', 'cui_str': 'Social phobia'}, {'cui': 'C0001818', 'cui_str': 'Agoraphobia'}, {'cui': 'C0030318', 'cui_str': 'Panic'}, {'cui': 'C0205211', 'cui_str': 'Subclinical'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0030481', 'cui_str': 'Human T-cell lymphotropic virus 1-associated myelopathy'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0585291', 'cui_str': 'Four times daily'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0199182', 'cui_str': 'History taking'}, {'cui': 'C4505426', 'cui_str': 'Mini International Neuropsychiatric Interview'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C3641330', 'cui_str': 'GAD-7'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0002783', 'cui_str': 'Studies, Epidemiologic'}, {'cui': 'C0582613', 'cui_str': 'Beck anxiety inventory'}, {'cui': 'C0030318', 'cui_str': 'Panic'}, {'cui': 'C0001818', 'cui_str': 'Agoraphobia'}, {'cui': 'C0031572', 'cui_str': 'Social phobia'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0233413', 'cui_str': 'Attentiveness'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",49.0,0.0454209,"RESULTS


Anxiety symptom severity (HAM-A d=1.19) and depressive symptoms (QIDS-C d=0.42) improved significantly, and 54% (21/39) no longer were diagnosed as having any anxiety disorder.","[{'ForeName': 'Kiona K', 'Initials': 'KK', 'LastName': 'Weisel', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Friedrich-Alexander University Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Anna-Carlotta', 'Initials': 'AC', 'LastName': 'Zarski', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Friedrich-Alexander University Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Berger', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Krieger', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Christian T', 'Initials': 'CT', 'LastName': 'Moser', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Schaub', 'Affiliation': 'Swiss Research Institute of Public Health and Addiction ISGF, Associated to the University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Görlich', 'Affiliation': 'Institute of Biostatistics and Clinical Research, Westfälische Wilhelms-Universität Münster, Münster, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Berking', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Friedrich-Alexander University Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'David D', 'Initials': 'DD', 'LastName': 'Ebert', 'Affiliation': 'Clinical, Neuro- & Development Psychology, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}]",Journal of medical Internet research,['10.2196/16450']
2748,32936087,Mobile Breast Cancer e-Support Program for Chinese Women With Breast Cancer Undergoing Chemotherapy (Part 3): Secondary Data Analysis.,"BACKGROUND


Many app-based interventions targeting women with breast cancer have been developed and tested for effectiveness. However, information regarding the evaluation of the usage of these interventions is scarce. A better understanding of usage data is important to determine how women use apps and how these interventions affect health outcomes.
OBJECTIVE


This study aimed to examine the usage duration and login frequency of an app-based intervention, the Breast Cancer e-Support (BCS) program, and to investigate the association between usage data and participants' demographic and medical characteristics.
METHODS


This study is a secondary data analysis of a randomized controlled trial assessing the effectiveness of the BCS program. The BCS program contains four modules: Learning Forum, Discussion Forum, Ask-the-Expert Forum, and Your Story Forum. A total of 57 women in the intervention group accessed the BCS program during their 12-week chemotherapy. The app's background system tracked the usage duration and login frequency for each forum and the entire BCS program.
RESULTS


The total usage duration per participant ranged from 0 to 9371 minutes, and the login frequency per participant ranged from 0 to 774 times. The Discussion Forum and the Learning Forum were the most frequently used modules. The general linear model showed that age, education, family monthly income, and employment were associated with BCS usage duration and/or login frequency. Age (F 1,45 =10.09, P=.003, B=115.34, 95% CI 42.22-188.47) and education level (F 1,45 =7.22, P=.01, B=1949.63, 95% CI 487.76-3411.50) were positively associated with the usage duration of the entire BCS program. Family monthly income was positively associated with the usage duration of the Learning Forum (F 1,45 =11.85, P=.001, B=1488.55, 95% CI 617.58-2359.51) and the login frequency of the entire BCS program (F 1,45 =4.47, P=.04, B=113.68, 95% CI 5.33-222.03). Employment was negatively associated with the usage duration of the Ask-the-expert Forum (F 1,45 =4.50, P=.04, B=-971.87, 95% CI -1894.66 to -49.07) and the Your Story Forum (F 1,45 =5.36, P=.03, B=-640.71, 95% CI -1198.30 to -83.11) and positively associated with the login frequency of the entire BCS program (F 1,45 =10.86, P=.002, B=192.88, 95% CI 75.01-310.74). No statistical differences were found between BCS usage data and cancer stage, BMI, comorbidity, types of surgery, or cycles of chemotherapy.
CONCLUSIONS


Overall, this study found considerable variability in the usage of app-based interventions. When health care professionals incorporate app-based interventions into their routine care for women with breast cancer, the learning and discussion functions of apps should be strengthened to promote engagement. Additionally, characteristics of women with breast cancer, such as age, level of education, income, and employment status, should be taken in consideration to develop tailored apps that address their particular needs and therefore improve their engagement with the app.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry ACTRN12616000639426; http://www.ANZCTR.org.au/ACTRN12616000639426.aspx.",2020,"Age (F 1,45 =10.09, P=.003, B=115.34","['Chinese Women', 'women with breast cancer', 'With Breast Cancer Undergoing Chemotherapy (Part 3', '57 women in the intervention group accessed the BCS program during their 12-week chemotherapy']","['Mobile Breast Cancer e-Support Program', 'app-based intervention, the Breast Cancer e-Support (BCS) program']","['education level', 'Your Story Forum', 'usage duration of the Ask-the-expert Forum', 'BCS usage data and cancer stage, BMI, comorbidity, types of surgery, or cycles of chemotherapy', 'usage duration of the Learning Forum', 'login frequency of the entire BCS program']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1172410', 'cui_str': 'ASK protein, human'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0027646', 'cui_str': 'Cancer staging'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C1268990', 'cui_str': 'Entire breast'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",57.0,0.0397284,"Age (F 1,45 =10.09, P=.003, B=115.34","[{'ForeName': 'Haihua', 'Initials': 'H', 'LastName': 'Zhu', 'Affiliation': 'Nursing Department, First Affiliated Hospital, Xiamen University, Xiamen, China.'}, {'ForeName': 'Xiuwan', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Nursing Department, First Affiliated Hospital, Xiamen University, Xiamen, China.'}, {'ForeName': 'Jinqiu', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Nursing, School of Medicine, Xiamen University, Xiamen, China.'}, {'ForeName': 'Qiaoling', 'Initials': 'Q', 'LastName': 'Wu', 'Affiliation': 'Hospital Infection Management Office, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Jiemin', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Department of Nursing, School of Medicine, Xiamen University, Xiamen, China.'}, {'ForeName': 'Sally Wai-Chi', 'Initials': 'SW', 'LastName': 'Chan', 'Affiliation': 'Global Engagement and Partnership Division, UON Singapore campus, University of Newcastle, Newcastle, Australia.'}]",JMIR mHealth and uHealth,['10.2196/18896']
2749,32937273,"Short-term and long-term effects of ankle joint taping and bandaging on balance, proprioception and vertical jump among volleyball players with chronic ankle instability.","OBJECTIVE


This study hypothesized that the prolonged use of taping during athletic activities produces more significant increases in proprioception, balance, and vertical jump among volleyball players with CAI.
DESIGN


A randomized controlled study.
PARTICIPANTS


One-hundred participants with chronic ankle instability (CAI) participated in this study. Participants were distributed into 3-groups: taping group, bandaging group, and control group.
PRIMARY OUTCOME MEASURES


Proprioception (ankle range of motion absolute error), balance(Y-balance test), and vertical jump (vertical jump tester).
INTERVENTIONS


Three interventions were performed: ankle rigid taping, ankle bandaging, and placebo taping. The measurements were performed at baseline, immediately, 2-weeks and 2-months after support.
RESULTS


Immediately after supports, there were non-significant differences between all groups for proprioception, balance (P < .05). There was a significant difference between banding and control groups, and taping and control groups for the vertical jump (P < .05). After 2-weeks and 2-months, there were significant differences between bandaging and control groups, and taping and control groups for proprioception, balance, and vertical jump (P < .05). There were non-significant differences between taping and bandaging groups (P < .05) during all assessments.
CONCLUSION


This study indicated that ankle taping and bandaging immediately improve vertical jump only; while they improve proprioception, balance, and vertical jump after 2-weeks and 2-months.",2020,"There was a significant difference between banding and control groups, and taping and control groups for the vertical jump (P ","['One-hundred participants with chronic ankle instability (CAI) participated in this study', 'volleyball players with CAI', 'volleyball players with chronic ankle instability']","['ankle joint taping and bandaging', 'taping group, bandaging group, and control group', 'ankle rigid taping, ankle bandaging, and placebo taping']","['proprioception, balance, and vertical jump', 'proprioception, balance, and vertical jump (P', 'Proprioception (ankle range of motion absolute error), balance(Y-balance test), and vertical jump (vertical jump tester', 'proprioception, balance', 'balance, proprioception and vertical jump']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3840097', 'cui_str': 'Chronic ankle instability'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1956059', 'cui_str': 'Volleyball'}]","[{'cui': 'C0003087', 'cui_str': 'Ankle joint structure'}, {'cui': 'C0150468', 'cui_str': 'Application of bandage'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0004726', 'cui_str': 'Bandage'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0026837', 'cui_str': 'Muscle rigidity'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0033499', 'cui_str': 'Proprioception'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0576183', 'cui_str': 'Ankle joint - range of movement'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0183885', 'cui_str': 'Tester'}]",100.0,0.0294532,"There was a significant difference between banding and control groups, and taping and control groups for the vertical jump (P ","[{'ForeName': 'Motaz', 'Initials': 'M', 'LastName': 'Alawna', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, School of Health Sciences, Istanbul Gelisim University, Istanbul, Turkey; Department of Physiotherapy and Rehabilitation, Faculty of Allied Medical Sciences, Arab American University, Jenin, Palestine. Electronic address: malawna@gelisim.edu.tr.'}, {'ForeName': 'Ayman A', 'Initials': 'AA', 'LastName': 'Mohamed', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, School of Health Sciences, Istanbul Gelisim University, Istanbul, Turkey.'}]",Physical therapy in sport : official journal of the Association of Chartered Physiotherapists in Sports Medicine,['10.1016/j.ptsp.2020.08.015']
2750,32940428,Study design of Heart failure Events reduction with Remote Monitoring and eHealth Support (HERMeS).,"AIMS


The role of non-invasive telemedicine (TM) combining telemonitoring and teleintervention by videoconference (VC) in patients recently admitted due to heart failure (HF) ('vulnerable phase' HF patients) is not well established. The aim of the Heart failure Events reduction with Remote Monitoring and eHealth Support (HERMeS) trial is to assess the impact on clinical outcomes of implementing a TM service based on mobile health (mHealth), which includes remote daily monitoring of biometric data and symptom reporting (telemonitoring) combined with VC structured, nurse-based follow-up (teleintervention). The results will be compared with those of the comprehensive HF usual care (UC) strategy based on face-to-face on-site visits at the vulnerable post-discharge phase.
METHODS AND RESULTS


We designed a 24 week nationwide, multicentre, randomized, controlled, open-label, blinded endpoint adjudication trial to assess the effect on cardiovascular (CV) mortality and non-fatal HF events of a TM-based comprehensive management programme, based on mHealth, for patients with chronic HF. Approximately 508 patients with a recent hospital admission due to HF decompensation will be randomized (1:1) to either structured follow-up based on face-to-face appointments (UC group) or the delivery of health care using TM. The primary outcome will be a composite of death from CV causes or non-fatal HF events (first and recurrent) at the end of a 6 month follow-up period. Key secondary endpoints will include components of the primary event analysis, recurrent event analysis, and patient-reported outcomes.
CONCLUSIONS


The HERMeS trial will assess the efficacy of a TM-based follow-up strategy for real-world 'vulnerable phase' HF patients combining telemonitoring and teleintervention.",2020,The HERMeS trial will assess the efficacy of a TM-based follow-up strategy for real-world 'vulnerable phase' HF patients combining telemonitoring and teleintervention.,"['Approximately 508 patients with a recent hospital admission due to HF decompensation', ""patients recently admitted due to heart failure (HF) ('vulnerable phase' HF patients"", 'patients with chronic HF']","['TM-based comprehensive management programme', 'non-invasive telemedicine (TM) combining telemonitoring and teleintervention by videoconference (VC', 'structured follow-up based on face-to-face appointments (UC group) or the delivery of health care using TM', 'Remote Monitoring and eHealth Support (HERMeS']","['components of the primary event analysis, recurrent event analysis, and patient-reported outcomes', 'cardiovascular (CV) mortality and non-fatal HF events', 'composite of death from CV causes or non-fatal HF events (first and recurrent']","[{'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0231187', 'cui_str': 'Decompensation'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1450049', 'cui_str': 'Videoconference'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0011211', 'cui_str': 'Health Care Delivery'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]","[{'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0015127', 'cui_str': 'etiology'}]",508.0,0.111182,The HERMeS trial will assess the efficacy of a TM-based follow-up strategy for real-world 'vulnerable phase' HF patients combining telemonitoring and teleintervention.,"[{'ForeName': 'Sergi', 'Initials': 'S', 'LastName': 'Yun', 'Affiliation': ""Community Heart Failure Program, Departments of Cardiology and Internal Medicine, Bellvitge University Hospital, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Enjuanes', 'Affiliation': ""Community Heart Failure Program, Departments of Cardiology and Internal Medicine, Bellvitge University Hospital, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Calero', 'Affiliation': ""Community Heart Failure Program, Departments of Cardiology and Internal Medicine, Bellvitge University Hospital, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Encarnación', 'Initials': 'E', 'LastName': 'Hidalgo', 'Affiliation': ""Community Heart Failure Program, Departments of Cardiology and Internal Medicine, Bellvitge University Hospital, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Cobo', 'Affiliation': 'Department of Cardiology, Puerta de Hierro Majadahonda University Hospital, Puerta de Hierro-Segovia de Arana Health Research Institute (IDIPHSA), Madrid, Spain.'}, {'ForeName': 'Pau', 'Initials': 'P', 'LastName': 'Llàcer', 'Affiliation': 'Department of Internal Medicine, Manises Hospital, Medical Research Institute of Hospital La Fe (IIS La Fe), València, Spain.'}, {'ForeName': 'José Manuel', 'Initials': 'JM', 'LastName': 'García-Pinilla', 'Affiliation': 'Biomedical Research Networking Center on Cardiovascular Diseases (CIBERCV), Carlos III Health Institute (ISCIII), Madrid, Spain.'}, {'ForeName': 'Álvaro', 'Initials': 'Á', 'LastName': 'González-Franco', 'Affiliation': 'Department of Internal Medicine, Central de Asturias University Hospital (HUCA), Foundation for Health and Biomedicine Research and Innovation of Asturias (FINBA), Oviedo, Spain.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Núñez', 'Affiliation': 'Biomedical Research Networking Center on Cardiovascular Diseases (CIBERCV), Carlos III Health Institute (ISCIII), Madrid, Spain.'}, {'ForeName': 'José Luis', 'Initials': 'JL', 'LastName': 'Morales-Rull', 'Affiliation': ""Department of Internal Medicine, Heart Failure Unit, Arnau de Vilanova University Hospital, Lleida Biomedical Research Institute's Dr. Pifarré Foundation (IRBLleida), Lleida, Spain.""}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Beltrán', 'Affiliation': ""Bellvitge Biomedical Research Institute (IDIBELL), L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Delso', 'Affiliation': ""Chronic Care Teams, Primary Care Service (SAP) Delta Llobregat, Foundation University Institute for Research in Primary Health Care Jordi Gol i Gurina (IDIAPJGol), L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Román', 'Initials': 'R', 'LastName': 'Freixa-Pamias', 'Affiliation': ""Bellvitge Biomedical Research Institute (IDIBELL), L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Moliner', 'Affiliation': ""Community Heart Failure Program, Departments of Cardiology and Internal Medicine, Bellvitge University Hospital, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Corbella', 'Affiliation': ""Bellvitge Biomedical Research Institute (IDIBELL), L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Comín-Colet', 'Affiliation': ""Community Heart Failure Program, Departments of Cardiology and Internal Medicine, Bellvitge University Hospital, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",ESC heart failure,['10.1002/ehf2.12962']
2751,32945775,Effect of Voluntary Participation on Mobile Health Care in Diabetes Management: Randomized Controlled Open-Label Trial.,"BACKGROUND


The role of mobile health care (mHealth) in glycemic control has been investigated, but its impact on self-management skills and its psychological aspects have not been studied.
OBJECTIVE


We evaluated the efficacy of mHealth-based diabetes self-management education and the effect of voluntary participation on its effects.
METHODS


This study was a randomized controlled open-label trial conducted for 6 months at Kangbuk Samsung Hospital. Participants in the control group (n=31) maintained their previous diabetes management strategies. Participants in the intervention group (n=41) additionally received mHealth-based diabetes self-management education through a mobile app and regular individualized feedback from health care professionals. The primary outcome was change in glycated hemoglobin (HbA 1c ) level over 6 months between the 2 groups (intervention versus control) and within each group (at 6 months versus baseline). The secondary outcomes were changes in body mass index, blood pressure, lipid profile, and questionnaire scores (the Korean version of the Summary of Diabetes Self-Care Activities Questionnaire, an Audit of Diabetes Dependent Quality of Life, the Appraisal of Diabetes Scale, and Problem Areas in Diabetes) over 6 months between groups and within each group.
RESULTS


A total of 66 participants completed this study. HbA 1c  (P=.04), total cholesterol level (P=.04), and Problem Areas in Diabetes scores (P=.02) significantly decreased; total diet (P=.03) and self-monitoring of blood glucose level scores (P=.01), based on the Summary of Diabetes Self-Care Activities Questionnaire, markedly increased within the intervention group. These significant changes were observed in self-motivated participants who were recruited voluntarily via advertisements.
CONCLUSIONS


mHealth-based diabetes self-management education was effective at improving glycemic control and diabetes self-management skills and lowering diabetes-related distress in voluntary participants.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03468283; http://clinicaltrials.gov/ct2/show/NCT03468283.",2020,"CONCLUSIONS


mHealth-based diabetes self-management education was effective at improving glycemic control and diabetes self-management skills and lowering diabetes-related distress in voluntary participants.
","['6 months at Kangbuk Samsung Hospital', 'Participants in the control group (n=31) maintained their previous diabetes management strategies', 'Diabetes Management', '66 participants completed this study']","['Voluntary Participation', 'mHealth-based diabetes self-management education', 'mHealth-based diabetes self-management education through a mobile app and regular individualized feedback from health care professionals']","['Mobile Health Care', 'total cholesterol level', 'Diabetes scores', 'glycated hemoglobin (HbA 1c ) level', 'self-monitoring of blood glucose level scores', 'Diabetes Self-Care Activities Questionnaire', 'changes in body mass index, blood pressure, lipid profile, and questionnaire scores (the Korean version of the Summary of Diabetes Self-Care Activities Questionnaire, an Audit of Diabetes Dependent Quality of Life, the Appraisal of Diabetes Scale, and Problem Areas in Diabetes']","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1319140', 'cui_str': 'Diabetes self-management behavior'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0005803', 'cui_str': 'Self-monitoring of blood glucose'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]",66.0,0.0783678,"CONCLUSIONS


mHealth-based diabetes self-management education was effective at improving glycemic control and diabetes self-management skills and lowering diabetes-related distress in voluntary participants.
","[{'ForeName': 'Da Young', 'Initials': 'DY', 'LastName': 'Lee', 'Affiliation': 'Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Seung-Hyun', 'Initials': 'SH', 'LastName': 'Yoo', 'Affiliation': 'Korea University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Kyong Pil', 'Initials': 'KP', 'LastName': 'Min', 'Affiliation': 'Huraypositive Inc, Seoul, Republic of Korea.'}, {'ForeName': 'Cheol-Young', 'Initials': 'CY', 'LastName': 'Park', 'Affiliation': 'Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}]",JMIR mHealth and uHealth,['10.2196/19153']
2752,32920492,A randomized-controlled trial of blonanserin and olanzapine as adjunct to antipsychotics in the treatment of patients with schizophrenia and dopamine supersensitivity psychosis: The ROADS study.,"Dopamine supersensitivity psychosis (DSP) is a key factor contributing to the development of antipsychotic treatment-resistant schizophrenia. We examined the efficacy and safety of blonanserin (BNS) and olanzapine (OLZ) as adjuncts to prior antipsychotic treatment in patients with schizophrenia and DSP in a 24-week, multicenter (17 sites), randomized, rater-blinded study with two parallel groups (BNS and OLZ add-on treatments) in patients with schizophrenia and DSP: the ROADS Study. The primary outcome was the change in the Positive and Negative Syndrome Scale (PANSS) total score from baseline to week 24. Secondary outcomes were changes in the PANSS subscale scores, Clinical Global Impressions, and Extrapyramidal Symptom Rating Scale (ESRS), and changes in antipsychotic doses. The 61 assessed patients were allocated into a BNS group (n = 26) and an OLZ group (n = 29). The PANSS total scores were reduced in both groups (mean ± SD: -14.8 ± 24.0, p = 0.0042; -10.5 ± 12.9, p = 0.0003; respectively) with no significant between-group difference (mean, -4.3, 95 %CI 15.1-6.4, p = 0.42). The BNS group showed significant reductions from week 4; the OLZ group showed significant reductions from week 8. The ESRS scores were reduced in the BNS group and the others were reduced in both groups. The antipsychotic monotherapy rates at the endpoint were 26.3 % (n = 6) for BNS and 23.8 % (n = 5) for OLZ. The concomitant antipsychotic doses were reduced in both groups with good tolerability. Our results suggest that augmentations with BNS and OLZ are antipsychotic treatment options for DSP patients, and BNS may be favorable for DSP based on the relatively quick responses to BNS observed herein.",2020,"Secondary outcomes were changes in the PANSS subscale scores, Clinical Global Impressions, and Extrapyramidal Symptom Rating Scale (ESRS), and changes in antipsychotic doses.","['patients with schizophrenia and dopamine supersensitivity psychosis', 'Dopamine supersensitivity psychosis (DSP', 'patients with schizophrenia and DSP in a 24-week, multicenter (17 sites', 'patients with schizophrenia and DSP']","['BNS', 'OLZ', 'antipsychotics', 'blonanserin (BNS) and olanzapine (OLZ', 'blonanserin and olanzapine']","['PANSS subscale scores, Clinical Global Impressions, and Extrapyramidal Symptom Rating Scale (ESRS), and changes in antipsychotic doses', 'antipsychotic monotherapy rates', 'change in the Positive and Negative Syndrome Scale (PANSS) total score', 'ESRS scores', 'PANSS total scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205145', 'cui_str': 'Site'}]","[{'cui': 'C0287983', 'cui_str': 'blonanserin'}, {'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}]","[{'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}, {'cui': 'C0459443', 'cui_str': 'Subscale score'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0234133', 'cui_str': 'Extrapyramidal sign'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0187611,"Secondary outcomes were changes in the PANSS subscale scores, Clinical Global Impressions, and Extrapyramidal Symptom Rating Scale (ESRS), and changes in antipsychotic doses.","[{'ForeName': 'Tomihisa', 'Initials': 'T', 'LastName': 'Niitsu', 'Affiliation': 'Department of Psychiatry, Chiba University Graduate School of Medicine, Chiba, Japan. Electronic address: niitsu@chiba-u.jp.'}, {'ForeName': 'Tatsuki', 'Initials': 'T', 'LastName': 'Hata', 'Affiliation': 'Department of Psychiatry, Chiba University Graduate School of Medicine, Chiba, Japan; Fujita Hospital, Sosa, Chiba, Japan.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Nishimoto', 'Affiliation': 'Soshu Hospital, Atsugi, Kanagawa, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Hosoda', 'Affiliation': 'Fujita Hospital, Sosa, Chiba, Japan; Child Psychiatry, Chiba University Hospital, Chiba, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Kimura', 'Affiliation': 'Department of Psychiatry, Chiba University Graduate School of Medicine, Chiba, Japan.'}, {'ForeName': 'Yasunori', 'Initials': 'Y', 'LastName': 'Oda', 'Affiliation': 'Department of Psychiatry, Chiba University Graduate School of Medicine, Chiba, Japan.'}, {'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Suzuki', 'Affiliation': 'Mobara Mental Hospital, Mobara, Chiba, Japan.'}, {'ForeName': 'Naoko', 'Initials': 'N', 'LastName': 'Takase', 'Affiliation': 'Mobara Mental Hospital, Mobara, Chiba, Japan.'}, {'ForeName': 'Ryota', 'Initials': 'R', 'LastName': 'Seki', 'Affiliation': 'Department of Psychiatry, Chiba University Graduate School of Medicine, Chiba, Japan; Chiba Hospital, Funabashi, Chiba, Japan.'}, {'ForeName': 'Kiyoshi', 'Initials': 'K', 'LastName': 'Fujita', 'Affiliation': 'Okehazama Hospital Fujita Kokoro Care Center, Toyoake, Aichi, Japan.'}, {'ForeName': 'Mitsugu', 'Initials': 'M', 'LastName': 'Endo', 'Affiliation': 'Asai Hospital, Togane, Chiba, Japan.'}, {'ForeName': 'Taisuke', 'Initials': 'T', 'LastName': 'Yoshida', 'Affiliation': 'Kisatazu Hospital, Kisarazu, Chiba, Japan.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Inoue', 'Affiliation': 'Katsushikabashi Hospital, Tokyo, Japan.'}, {'ForeName': 'Noriaki', 'Initials': 'N', 'LastName': 'Hattori', 'Affiliation': 'Johmoh Hospital, Maebashi, Gunma, Japan.'}, {'ForeName': 'Tadashi', 'Initials': 'T', 'LastName': 'Murakami', 'Affiliation': 'Sanmaibashi Hospital, Ota, Gunma, Japan.'}, {'ForeName': 'Yukitsugu', 'Initials': 'Y', 'LastName': 'Imamura', 'Affiliation': 'Department of Neuropsychiatry, Asahi General Hospital, Asahi, Chiba, Japan.'}, {'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Ogawa', 'Affiliation': 'Yowa Hospital, Tokyo, Japan; Department of Neuropsychiatry, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Goro', 'Initials': 'G', 'LastName': 'Fukami', 'Affiliation': 'Chiba Psychiatric Medical Center, Chiba, Japan.'}, {'ForeName': 'Takatoshi', 'Initials': 'T', 'LastName': 'Sato', 'Affiliation': 'Project Leader Office, Clinical Research Center, Chiba University Hospital, Chiba, Japan.'}, {'ForeName': 'Yohei', 'Initials': 'Y', 'LastName': 'Kawasaki', 'Affiliation': 'Biostatistics Section, Clinical Research Center, Chiba University Hospital, Chiba, Japan.'}, {'ForeName': 'Tasuku', 'Initials': 'T', 'LastName': 'Hashimoto', 'Affiliation': 'Department of Psychiatry, Chiba University Graduate School of Medicine, Chiba, Japan; Sodegaura-Satsukidai Hospital, Sodegaura, Chiba, Japan.'}, {'ForeName': 'Masatomo', 'Initials': 'M', 'LastName': 'Ishikawa', 'Affiliation': 'Department of Psychiatry, Chiba University Graduate School of Medicine, Chiba, Japan.'}, {'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Shiina', 'Affiliation': 'Department of Psychiatry, Chiba University Graduate School of Medicine, Chiba, Japan; Division of Medical Treatment and Rehabilitation, Center for Forensic Mental Health, Chiba University, Chiba, Japan.'}, {'ForeName': 'Nobuhisa', 'Initials': 'N', 'LastName': 'Kanahara', 'Affiliation': 'Department of Psychiatry, Chiba University Graduate School of Medicine, Chiba, Japan; Division of Medical Treatment and Rehabilitation, Center for Forensic Mental Health, Chiba University, Chiba, Japan.'}, {'ForeName': 'Masaomi', 'Initials': 'M', 'LastName': 'Iyo', 'Affiliation': 'Department of Psychiatry, Chiba University Graduate School of Medicine, Chiba, Japan; Child Psychiatry, Chiba University Hospital, Chiba, Japan; Division of Medical Treatment and Rehabilitation, Center for Forensic Mental Health, Chiba University, Chiba, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Asian journal of psychiatry,['10.1016/j.ajp.2020.102369']
2753,32924568,Impact of Fast-Acting Insulin Aspart on Glycemic Control in Patients with Type 1 Diabetes Using Intermittent-Scanning Continuous Glucose Monitoring Within a Real-World Setting: The GoBolus Study.,"Background:  The GoBolus study investigated the real-world effectiveness of faster aspart in patients with type 1 diabetes (T1D) using intermittent-scanning continuous glucose monitoring (iscCGM) systems.  Methods:  This 24-week, multicenter, single-arm, noninterventional study investigated adults with T1D (HbA 1c , 7.5%-9.5%) receiving multiple daily injections (MDI) of insulin and using iscCGM within local healthcare settings for ≥6 months before switching to faster aspart at study start (week 0; baseline). Primary endpoint was HbA 1c  change from baseline to week 24. Exploratory endpoint was change in iscCGM metrics from baseline to week 24.  Results:  Overall, 243 patients were included (55.6% male), with mean age/diabetes duration, 49.9/18.8 years; mean HbA 1c , 8.1%. By week 24, HbA 1c  had decreased by 0.19% (-2.1 mmol/mol,  P  < 0.0001) with no mean change in insulin doses or basal/bolus insulin ratios. For patients with sufficient available iscCGM data ( n  = 92): ""time in range"" (TIR; 3.9-10.0 mmol/L) increased from 46.9% to 50.1% ( P  = 0.01), corresponding to an increase of 46.1 min/day; time in hyperglycemia decreased from 49.1% to 46.1% (>10.0 mmol/L,  P  = 0.026) and 20.4% to 17.9% (>13.9 mmol/L,  P  = 0.013), corresponding to 43.5 ( P  = 0.024) and 35.6 ( P  = 0.015) fewer minutes per day on average spent in these ranges, respectively; no change for time in hypoglycemia (<3.9 and <3.0 mmol/L). Mean interstitial and postprandial glucose improved from 10.4 to 10.1 mmol/L ( P  = 0.035) and 11.9 to 11.0 mmol/L ( P  = 0.002), respectively.  Conclusion:  Real-world switching to faster aspart in adults with T1D on MDI improved HbA 1c , increased TIR, and decreased time in hyperglycemia without affecting time in hypoglycemia. The GoBolus study: NCT03450863.",2020,"Mean interstitial and postprandial glucose improved from 10.4 to 10.1 mmol/L (p=0.035) and 11.9 to 11.0 mmol/L (p=0.002), respectively.
","['Patients with Type 1 Diabetes Using Intermittent-Scanning Continuous Glucose Monitoring Within a Real-World Setting - The GoBolus Study', 'adults with T1D (HbA1c, 7.5-9.5%) receiving multiple daily insulin injections (MDI) and using iscCGM within local healthcare settings for ≥6 months prior to switching to faster aspart at study start (Week 0; baseline', '243 patients were included (55.6% male), with mean: age/diabetes duration, 49.9/18.8 years; HbA1c, 8.1', 'patients with type 1 diabetes (T1D) using intermittent-scanning continuous glucose monitoring (iscCGM) systems']",['Fast-Acting Insulin Aspart'],"['iscCGM metrics', 'Mean interstitial and postprandial glucose', 'time in hyperglycemia', 'insulin doses or basal/bolus insulin ratios', 'MDI improved HbA1c, increased TIR, and decreased time in hyperglycemia', 'time in hypoglycemia', 'HbA1c change']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C4517899', 'cui_str': '9.5'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0199782', 'cui_str': 'Administration of insulin'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0123677', 'cui_str': 'Insulin, Aspart, Human'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517875', 'cui_str': '8.1'}, {'cui': 'C0011854', 'cui_str': 'Type 1 diabetes mellitus'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0123677', 'cui_str': 'Insulin, Aspart, Human'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1522203', 'cui_str': 'Interstitial route'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0199782', 'cui_str': 'Administration of insulin'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0574173', 'cui_str': 'Tigrinya language'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",243.0,0.0333406,"Mean interstitial and postprandial glucose improved from 10.4 to 10.1 mmol/L (p=0.035) and 11.9 to 11.0 mmol/L (p=0.002), respectively.
","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Danne', 'Affiliation': ""Diabetes Center for Children and Adolescents, Children's Hospital on the Bult, Hanover Medical School, Hanover, Germany.""}, {'ForeName': 'Matthias Axel', 'Initials': 'MA', 'LastName': 'Schweitzer', 'Affiliation': 'Novo Nordisk Pharma GmbH, Mainz, Germany.'}, {'ForeName': 'Winfried', 'Initials': 'W', 'LastName': 'Keuthage', 'Affiliation': 'Schwerpunktpraxis für Diabetes und Ernährungsmedizin, Muenster, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Kipper', 'Affiliation': 'Novo Nordisk Pharma GmbH, Mainz, Germany.'}, {'ForeName': 'Yasmin', 'Initials': 'Y', 'LastName': 'Kretzschmar', 'Affiliation': 'Novo Nordisk Pharma GmbH, Mainz, Germany.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Simon', 'Affiliation': 'Medizinisches Versorgungszentrum im Altstadt-Carree Fulda GmbH, Fulda, Germany.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Wiedenmann', 'Affiliation': 'Novo Nordisk Pharma GmbH, Mainz, Germany.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Ziegler', 'Affiliation': 'Diabetes Clinic for Children and Adolescents, Muenster, Germany.'}]",Diabetes technology & therapeutics,['10.1089/dia.2020.0360']
2754,32924589,People living with dementia and their family carers' adherence to home-based Tai Chi practice.,"OBJECTIVES


The aim of this study was to understand what influenced people living with dementia and their family carers' adherence to the home-based component of a Tai Chi exercise intervention.
METHOD


Dyads, of people living with dementia and their family carers, who participated in the intervention arm of the Tai Chi for people living with dementia trial, were invited to join weekly Tai Chi classes for 20 weeks and practice at home. Semi-structured dyadic home interviews were conducted on average after 16 weeks of classes. The views of 15 dyads with a range of home practice adherence were sought in semi-structured interviews. The interviews were analysed using an inductive thematic approach.
RESULTS


Most participants found time to practise Tai Chi at home and practised for 18 hours on average. Amongst the barriers to adherence were participants' competing commitments and a booklet not sufficiently conveying the Tai Chi movements. Hence, a video or DVD was requested by participants. Facilitators of their adherence to the home-based component of the intervention were their enjoyment of the practice and the development of a habit, which was supported by their commitment to the study and their willingness to benefit from Tai Chi.
CONCLUSION


Enjoyment and perceived benefits had a great impact on participants living with dementia and their carers' adherence to home-based Tai Chi practice. However, difficulties to perceive the Tai Chi movements through images might be hindering sustained participation. Hence, alternative aids such as videos and DVDs should be explored to facilitate adherence.",2020,"Facilitators of their adherence to the home-based component of the intervention were their enjoyment of the practice and the development of a habit, which was supported by their commitment to the study and their willingness to benefit from Tai Chi.
CONCLUSION


Enjoyment and perceived benefits had a great impact on participants living with dementia and their carers' adherence to home-based Tai Chi practice.","[""People living with dementia and their family carers' adherence to home-based Tai Chi practice"", 'Dyads, of people living with dementia and their family carers, who participated in the intervention arm of the Tai Chi for people living with dementia trial', ""people living with dementia and their family carers' adherence"", ""participants living with dementia and their carers' adherence to home-based Tai Chi practice""]",['Tai Chi exercise intervention'],[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0376403', 'cui_str': 'Tai-chi'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0376403', 'cui_str': 'Tai-chi'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],15.0,0.0446001,"Facilitators of their adherence to the home-based component of the intervention were their enjoyment of the practice and the development of a habit, which was supported by their commitment to the study and their willingness to benefit from Tai Chi.
CONCLUSION


Enjoyment and perceived benefits had a great impact on participants living with dementia and their carers' adherence to home-based Tai Chi practice.","[{'ForeName': 'Yolanda', 'Initials': 'Y', 'LastName': 'Barrado-Martín', 'Affiliation': 'Department of Psychology and Ageing & Dementia Research Centre (ADRC), 6657Bournemouth University, Fern Barrow, Poole, UK Centre for Ageing & Population Studies, Research Department of Primary Care & Population Health, London, UK.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Heward', 'Affiliation': 'Ageing & Dementia Research Centre (ADRC) and Department of Rehabilitation and Sport Science, 6657Bournemouth University, Fern Barrow, Poole, UK.'}, {'ForeName': 'Remco', 'Initials': 'R', 'LastName': 'Polman', 'Affiliation': 'School Exercise & Nutrition Sciences, 72524Queensland University of Technology, Australia.'}, {'ForeName': 'Samuel R', 'Initials': 'SR', 'LastName': 'Nyman', 'Affiliation': 'Department of Psychology and Ageing & Dementia Research Centre (ADRC), 6657Bournemouth University, Fern Barrow, Poole, UK Department of Medical Science, Public Health, Bournemouth University, Fern Barrow, Poole, UK.'}]","Dementia (London, England)",['10.1177/1471301220957758']
2755,32928279,A phase II randomized trial of sodium oligomannate in Alzheimer's dementia.,"BACKGROUND


Sodium oligomannate (GV-971), a marine-derived oligosaccharide, is a novel agent that may improve cognition in AD patients.
METHODS


The 24-week multicenter, randomized, double-blind, placebo parallel controlled clinical trial was conducted in AD in China between 24 October 2011 and 10 July 2013. The study included a 4-week screening/washout period, followed by a 24-week treatment period. Patients were randomized in a 1:1:1 ratio to receive GV-971 900 mg, 600 mg, or placebo capsule in treatment period, respectively. The primary outcome was cognitive improvement as assessed by changes in Alzheimer's Disease Assessment Scale-cognitive subscale 12-item (ADAS-cog12) scores from baseline to week 24. The secondary efficacy outcomes included CIBIC-Plus, ADCS-ADL, and NPI at 24 weeks after treatment compared with baseline. A subgroup study was assessment of the change in cerebral glucose metabolism by fluorodeoxyglucose positron emission tomography measurements.
RESULTS


Comparing with the placebo group (n = 83, change - 1.45), the ADAS-cog12 score change in the GV-971 600-mg group (n = 76) was - 1.39 (p = 0.89) and the GV-971 900-mg group (n = 83) was - 2.58 (p = 0.30). The treatment responders according to CIBIC-Plus assessment were significantly higher in the GV-971 900-mg group than the placebo group (92.77% vs. 79.52%, p < 0.05). The GV-971 900-mg subgroup showed a lower decline of cerebral metabolic rate for glucose than the placebo subgroup at the left precuneus, right posterior cingulate, bilateral hippocampus, and bilateral inferior orbital frontal at uncorrected p = 0.05. The respective rates of treatment-related AEs were 5.9%, 14.3%, and 3.5%.
CONCLUSIONS


GV-971 was safe and well tolerated. GV-971 900 mg was chosen for phase III clinical study.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT01453569 . Registered on October 18, 2011.",2020,"The GV-971 900-mg subgroup showed a lower decline of cerebral metabolic rate for glucose than the placebo subgroup at the left precuneus, right posterior cingulate, bilateral hippocampus, and bilateral inferior orbital frontal at uncorrected p = 0.05.","[""Alzheimer's dementia"", 'AD patients', 'AD in China between 24 October 2011 and 10 July 2013']","['placebo', 'GV-971 900\u2009mg, 600\u2009mg, or placebo', 'sodium oligomannate', 'GV-971']","['respective rates of treatment-related AEs', 'safe and well tolerated', 'CIBIC-Plus, ADCS-ADL, and NPI', 'cerebral metabolic rate for glucose', ""cognitive improvement as assessed by changes in Alzheimer's Disease Assessment Scale-cognitive subscale 12-item"", 'ADAS-cog12 score change', 'cerebral glucose metabolism']","[{'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4517900', 'cui_str': '900'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0450989', 'cui_str': ""Alzheimer's Disease Assessment Scale""}, {'cui': 'C0559741', 'cui_str': 'Item score'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}]",,0.566234,"The GV-971 900-mg subgroup showed a lower decline of cerebral metabolic rate for glucose than the placebo subgroup at the left precuneus, right posterior cingulate, bilateral hippocampus, and bilateral inferior orbital frontal at uncorrected p = 0.05.","[{'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': 'Department of Geriatric Psychiatry, Shanghai Mental Health Center, Shanghai Jiaotong University School of Medicine, Shanghai, China. wtshhwy@163.com.'}, {'ForeName': 'Weihong', 'Initials': 'W', 'LastName': 'Kuang', 'Affiliation': 'Department of Psychiatry, West China Hospital of Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'Department of Neurology, Sir Run Run Shaw Hospital, Affiliated with the Zhejiang University School of Medicine, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Wenwei', 'Initials': 'W', 'LastName': 'Xu', 'Affiliation': 'Department of Geriatric Psychiatry, Wuxi Mental Health Center, Wuxi, Jiangsu, China.'}, {'ForeName': 'Liming', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurology, First Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang, China.'}, {'ForeName': 'Yingjie', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Neurology, The Hospital of 81st Group Army PLA, Zhangjiakou, Hebei, China.'}, {'ForeName': 'Hailin', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Geriatric Psychiatry, Nanjing Brain Hospital Affiliated to Nanjing Medical University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Peng', 'Affiliation': 'Department of Neurology, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Yangmei', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Neurology, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Baojun', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Baotou Central Hospital, Baotou, Inner Mongolia Autonomous Region, China.'}, {'ForeName': 'Jinsong', 'Initials': 'J', 'LastName': 'Xiao', 'Affiliation': 'Department of Neurology, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China.'}, {'ForeName': 'Honghua', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': ""Department of Neurology, Central War Zone General Hospital of the Chinese People's Liberation Army, Wuhan, Hubei, China.""}, {'ForeName': 'Chuanzhu', 'Initials': 'C', 'LastName': 'Yan', 'Affiliation': 'Department of Neurology, Qilu Hospital of Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Yifeng', 'Initials': 'Y', 'LastName': 'Du', 'Affiliation': 'Department of Neurology, Shandong Provincial Hospital, Jinan, Shandong, China.'}, {'ForeName': 'Mouni', 'Initials': 'M', 'LastName': 'Tang', 'Affiliation': 'Department of Geriatric Psychiatry, Guangzhou Brian Hospital, Guangzhou, Guangdong, China.'}, {'ForeName': 'Zhiyi', 'Initials': 'Z', 'LastName': 'He', 'Affiliation': 'Department of Neurology, The First Hospital of China Medical University, Shenyang, Liaoning, China.'}, {'ForeName': 'Haibo', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Neurology, Beijing Hospital, Beijing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': ""Department of Neurology, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Lin', 'Affiliation': ""Department of Neurology, Tangdu Hospital, Air Force Military Medical University, Xi'an, Shanxi, China.""}, {'ForeName': 'Shugui', 'Initials': 'S', 'LastName': 'Shi', 'Affiliation': 'Department of Neurology, The First Hospital Affiliated to AMU (Southwest Hospital), Chongqing, China.'}, {'ForeName': 'Jianzhong', 'Initials': 'J', 'LastName': 'Bi', 'Affiliation': 'Department of Neurology, The Second Hospital of Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Huadong', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': 'Department of Neurology, Daping Hospital, Chongqing, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'Department of Neurology, Tianjin Medical University general hospital, Tianjin, China.'}, {'ForeName': 'Xiaoping', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': ""Department of Neurology, Hunan Provincial People's Hospital, Changsha, Hunan, China.""}, {'ForeName': 'Yihui', 'Initials': 'Y', 'LastName': 'Guan', 'Affiliation': 'PET Center Huashan Hospital Fudan University, Shanghai, China.'}, {'ForeName': 'Qiu', 'Initials': 'Q', 'LastName': 'Huang', 'Affiliation': 'Med-X Research Institution, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Kewei', 'Initials': 'K', 'LastName': 'Chen', 'Affiliation': ""Banner Alzheimer's Institute, Phoenix, AZ, USA.""}, {'ForeName': 'Xianliang', 'Initials': 'X', 'LastName': 'Xin', 'Affiliation': 'Shanghai Green Valley Pharmaceutical Co Ltd, Shanghai, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Ding', 'Affiliation': 'State Key Laboratory of Drug Research, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, 555 Zu Chong Zhi Road, Shanghai, 201203, China.'}, {'ForeName': 'Meiyu', 'Initials': 'M', 'LastName': 'Geng', 'Affiliation': 'State Key Laboratory of Drug Research, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, 555 Zu Chong Zhi Road, Shanghai, 201203, China. mygeng@simm.ac.cn.'}, {'ForeName': 'Shifu', 'Initials': 'S', 'LastName': 'Xiao', 'Affiliation': 'Department of Geriatric Psychiatry, Shanghai Mental Health Center, Shanghai Jiaotong University School of Medicine, Shanghai, China. xiaoshifu@msn.com.'}]",Alzheimer's research & therapy,['10.1186/s13195-020-00678-3']
2756,32927145,"A commentary on ""the effect of increased abdominal pressure on internal jugular vein catheterization under ultrasound-guidance on conscious patients: A randomised controlled trial"" (International Journal of Surgery 2020; 77:183-6).",,2020,,['conscious patients'],['internal jugular vein catheterization under ultrasound-guidance'],[],"[{'cui': 'C0234421', 'cui_str': 'Consciousness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0226550', 'cui_str': 'Internal jugular vein structure'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0442973', 'cui_str': 'Ultrasonic guidance procedure'}]",[],,0.0942218,,"[{'ForeName': 'Baoji', 'Initials': 'B', 'LastName': 'Hu', 'Affiliation': 'Department of Anesthesia, Shanghai Pudong Hospital, Fudan University Pudong Medical Center, 2800, Gongwei Rd. Pudong New District, Shanghai, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Department of Anesthesia, Shanghai Pudong Hospital, Fudan University Pudong Medical Center, 2800, Gongwei Rd. Pudong New District, Shanghai, China.'}, {'ForeName': 'Hongwei', 'Initials': 'H', 'LastName': 'Duan', 'Affiliation': 'Department of Anesthesia, Shanghai Pudong Hospital, Fudan University Pudong Medical Center, 2800, Gongwei Rd. Pudong New District, Shanghai, China. Electronic address: duanhongwei120@126.com.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.08.047']
2757,32931984,The clinical effectiveness of intensive management in moderate established rheumatoid arthritis: The titrate trial.,"OBJECTIVES


Many trials have shown that intensive management is effective in patients with early active rheumatoid arthritis (RA). But its benefits are unproven for the large number of RA patients seen in routine care who have established, moderately active RA and are already taking conventional synthetic disease modifying anti-rheumatic drugs (csDMARDs). The TITRATE trial studied whether these patients also benefit from intensive management and, in particular, achieve more remissions.
METHODS


A 12-month multicentre individually randomised trial compared standard care with monthly intensive management appointments which was delivered by specially trained healthcare professionals and incorporated monthly clinical assessments, medication titration and psychosocial support. The primary outcome was 12-month remission assessed using the Disease Activity Score for 28 joints using ESR (DAS28-ESR). Secondary outcomes included fatigue, disability, harms and healthcare costs. Intention-to-treat multivariable logistic- and linear regression analyses compared treatment arms with multiple imputation used for missing data.
RESULTS


459 patients were screened and 335 were randomised (168 intensive management; 167 standard care); 303 (90%) patients provided 12-month outcomes. Intensive management increased DAS28-ESR 12-month remissions compared to standard care (32% vs 18%, p = 0.004). Intensive management also significantly increased remissions using a range of alternative remission criteria and increased patients with DAS28-ESR low disease activity scores. (48% vs 32%, p = 0.005). In addition it substantially reduced fatigue (mean difference -18; 95% CI: -24, -11, p<0.001). There was no evidence that serious adverse events (intensive management =15 vs standard care =11) or other adverse events (114 vs 151) significantly increase with intensive management.
INTERPRETATION


The trial shows that intensive management incorporating psychosocial support delivered by specially trained healthcare professions is effective in moderately active established RA. More patients achieve remissions, there were greater improvements in fatigue, and there were no more harms.",2020,"Intensive management increased DAS28-ESR 12-month remissions compared to standard care (32% vs 18%, p = 0.004).","['459 patients were screened and 335 were randomised (168 intensive management; 167 standard care); 303 (90%) patients provided 12-month outcomes', 'patients with early active rheumatoid arthritis (RA', 'moderate established rheumatoid arthritis']","['standard care with monthly intensive management appointments which was delivered by specially trained healthcare professionals', 'intensive management']","['12-month remission assessed using the Disease Activity Score for 28 joints using ESR (DAS28-ESR', 'DAS28-ESR 12-month remissions', 'adverse events', 'fatigue, disability, harms and healthcare costs', 'fatigue', 'DAS28-ESR low disease activity scores', 'serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4709307', 'cui_str': '335'}, {'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C4517595', 'cui_str': '167'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0013845', 'cui_str': 'Electron spin resonance measurement'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0151631', 'cui_str': 'Low erythrocyte sedimentation rate'}]",459.0,0.189248,"Intensive management increased DAS28-ESR 12-month remissions compared to standard care (32% vs 18%, p = 0.004).","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Scott', 'Affiliation': ""Centre for Rheumatic Diseases, Department of Inflammation Biology, School of Immunology and Microbial Sciences, Faculty of Life Sciences and Medicine, King's College London Cutcombe Road, London, SE5 9RJ, United Kingdom.""}, {'ForeName': 'Fowzia', 'Initials': 'F', 'LastName': 'Ibrahim', 'Affiliation': ""Centre for Rheumatic Diseases, Department of Inflammation Biology, School of Immunology and Microbial Sciences, Faculty of Life Sciences and Medicine, King's College London Cutcombe Road, London, SE5 9RJ, United Kingdom. Electronic address: fowzia.ibrahim@kcl.ac.uk.""}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Hill', 'Affiliation': 'ScHARR Health Economics and Decision Science, The University of Sheffield, Regent Court, 30 Regent Street, Sheffield, S1 4DA, United Kingdom.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Tom', 'Affiliation': 'MRC Biostatistics Unit, University of Cambridge, Cambridge Institute of Public Health, Forvie Site, Robinson Way, Cambridge Biomedical Campus, Cambridge, CB2 0SR, United Kingdom.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Prothero', 'Affiliation': ""Centre for Rheumatic Diseases, Department of Inflammation Biology, School of Immunology and Microbial Sciences, Faculty of Life Sciences and Medicine, King's College London Cutcombe Road, London, SE5 9RJ, United Kingdom.""}, {'ForeName': 'Rhiannon R', 'Initials': 'RR', 'LastName': 'Baggott', 'Affiliation': ""Centre for Rheumatic Diseases, Department of Inflammation Biology, School of Immunology and Microbial Sciences, Faculty of Life Sciences and Medicine, King's College London Cutcombe Road, London, SE5 9RJ, United Kingdom.""}, {'ForeName': 'Ailsa', 'Initials': 'A', 'LastName': 'Bosworth', 'Affiliation': 'National Rheumatoid Arthritis Society (NRAS), Switchback Office Park, Gardner Rd, Maidenhead, SL6 7RJ, United Kingdom.'}, {'ForeName': 'James B', 'Initials': 'JB', 'LastName': 'Galloway', 'Affiliation': ""Centre for Rheumatic Diseases, Department of Inflammation Biology, School of Immunology and Microbial Sciences, Faculty of Life Sciences and Medicine, King's College London Cutcombe Road, London, SE5 9RJ, United Kingdom.""}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Georgopoulou', 'Affiliation': ""Centre for Rheumatic Diseases, Department of Inflammation Biology, School of Immunology and Microbial Sciences, Faculty of Life Sciences and Medicine, King's College London Cutcombe Road, London, SE5 9RJ, United Kingdom.""}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Martin', 'Affiliation': ""Centre for Rheumatic Diseases, Department of Inflammation Biology, School of Immunology and Microbial Sciences, Faculty of Life Sciences and Medicine, King's College London Cutcombe Road, London, SE5 9RJ, United Kingdom.""}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Neatrour', 'Affiliation': ""Centre for Rheumatic Diseases, Department of Inflammation Biology, School of Immunology and Microbial Sciences, Faculty of Life Sciences and Medicine, King's College London Cutcombe Road, London, SE5 9RJ, United Kingdom.""}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Nikiphorou', 'Affiliation': ""Centre for Rheumatic Diseases, Department of Inflammation Biology, School of Immunology and Microbial Sciences, Faculty of Life Sciences and Medicine, King's College London Cutcombe Road, London, SE5 9RJ, United Kingdom.""}, {'ForeName': 'Jackie', 'Initials': 'J', 'LastName': 'Sturt', 'Affiliation': ""Department Of Adult Nursing, Florence Nightingale Faculty of Nursing, Midwifery & Palliative Care, King's College London, James Clerk Maxwell Building, 57 Waterloo Road, London SE1 8WA, United Kingdom.""}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Wailoo', 'Affiliation': 'ScHARR Health Economics and Decision Science, The University of Sheffield, Regent Court, 30 Regent Street, Sheffield, S1 4DA, United Kingdom.'}, {'ForeName': 'Frances M K', 'Initials': 'FMK', 'LastName': 'Williams', 'Affiliation': ""Twin Research & Genetic Epidemiology, School of Life Course Sciences, King's College London, St Thomas' Hospital, London SE1 7EH, United Kingdom.""}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Williams', 'Affiliation': ""Centre for Rheumatic Diseases, Department of Inflammation Biology, School of Immunology and Microbial Sciences, Faculty of Life Sciences and Medicine, King's College London Cutcombe Road, London, SE5 9RJ, United Kingdom.""}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Lempp', 'Affiliation': ""Centre for Rheumatic Diseases, Department of Inflammation Biology, School of Immunology and Microbial Sciences, Faculty of Life Sciences and Medicine, King's College London Cutcombe Road, London, SE5 9RJ, United Kingdom.""}]",Seminars in arthritis and rheumatism,['10.1016/j.semarthrit.2020.07.014']
2758,32937016,Performance and Predictors of Minimal Disease Activity Response in Peripheral Spondyloarthritis Patients Treated With Adalimumab.,"OBJECTIVES


To examine concurrent validity and discrimination of modified minimal disease activity (mMDA) criteria in peripheral spondyloarthritis (pSpA) following OMERACT filter principles and determine predictors of mMDA response.
METHODS


Four mMDA versions were derived in the ABILITY-2 study using the SPondyloArthritis Research Consortium of Canada (SPARCC) or Leeds Enthesitis Index (LEI) but excluding psoriasis. To assess concurrent validity, mMDA versions were correlated with Peripheral SpondyloArthritis Response Criteria (PSpARC) remission, Ankylosing Spondylitis Disease Activity Score for inactive disease (ASDAS ID), and physician global. Treatment discrimination was assessed between adalimumab and placebo at week 12. Multiple logistic regression was used to determine baseline predictors of long-term mMDA responses and sustained mMDA.
RESULTS


The four mMDA versions showed a stronger positive correlation with PSpARC remission (r tet  >0.95) versus ASDAS ID (r tet  >0.75) at week 12 and years 1-3 and were able to show discrimination (p<0.001). Responsiveness was shown at week 12; significantly more patients receiving adalimumab versus placebo achieved all four versions of mMDA. Approximately 40-60% of adalimumab-treated patients achieved mMDA-LEI or SPARCC at years 1-3. Achieving mMDA response after 12 weeks of adalimumab treatment was a robust positive predictor of attaining long-term mMDA through 3 years (odds ratios: 11.38-27.13 for mMDA-LEI; 17.98-37.85 for mMDA-SPARCC).
CONCLUSIONS


All four versions of mMDA showed concurrent validity and discriminated well between adalimumab and placebo treatment groups. Early mMDA response is a more consistent predictor of long-term mMDA achievement than baseline characteristics. The 5 of 6 versions of mMDA could be an appropriate treatment target in pSpA patients.",2020,Responsiveness was shown at week 12; significantly more patients receiving adalimumab versus placebo achieved all four versions of mMDA.,"['Four mMDA versions were derived in the ABILITY-2 study using the SPondyloArthritis Research Consortium of Canada (SPARCC) or Leeds Enthesitis Index (LEI) but excluding psoriasis', 'Peripheral Spondyloarthritis Patients Treated With']","['adalimumab', 'Adalimumab', 'adalimumab and placebo', 'placebo']","['PSpARC remission', 'mMDA-LEI or SPARCC', 'Achieving mMDA response', 'Peripheral SpondyloArthritis Response Criteria (PSpARC) remission, Ankylosing Spondylitis Disease Activity Score for inactive disease (ASDAS ID), and physician global', 'Performance and Predictors of Minimal Disease Activity Response']","[{'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0949690', 'cui_str': 'Arthritis of spine'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0451148', 'cui_str': 'Enthesitis index'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C4511579', 'cui_str': 'Peripheral spondyloarthritis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C4511579', 'cui_str': 'Peripheral spondyloarthritis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0451148', 'cui_str': 'Enthesitis index'}, {'cui': 'C0949690', 'cui_str': 'Arthritis of spine'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0038013', 'cui_str': 'Ankylosing spondylitis'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}]",,0.111974,Responsiveness was shown at week 12; significantly more patients receiving adalimumab versus placebo achieved all four versions of mMDA.,"[{'ForeName': 'Laura C', 'Initials': 'LC', 'LastName': 'Coates', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Sonya', 'Initials': 'S', 'LastName': 'Abraham', 'Affiliation': 'NIHR/Wellcome CRF, Imperial College Healthcare NHS Trust, London, United Kingdom.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Tillett', 'Affiliation': 'Royal National Hospital for Rheumatic Diseases, Pharmacy and Pharmacology, University of Bath, Bath, United Kingdom.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Mease', 'Affiliation': 'Swedish Medical Center/Providence St, Joseph Health and University of Washington, Seattle, WA, United States.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Ramiro', 'Affiliation': 'Leiden University Medical Center, Leiden, and Zuyderland Medical Center, Heerlen, the Netherlands.'}, {'ForeName': 'Tianshuang', 'Initials': 'T', 'LastName': 'Wu', 'Affiliation': 'AbbVie Inc, North Chicago, IL, United States.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'AbbVie Inc, North Chicago, IL, United States.'}, {'ForeName': 'Aileen L', 'Initials': 'AL', 'LastName': 'Pangan', 'Affiliation': 'AbbVie Inc, North Chicago, IL, United States.'}, {'ForeName': 'In-Ho', 'Initials': 'IH', 'LastName': 'Song', 'Affiliation': 'AbbVie Inc, North Chicago, IL, United States.'}]",Arthritis care & research,['10.1002/acr.24442']
2759,32942294,The effects of pre-intervention mindset induction on a brief intervention to increase risk perception and reduce alcohol use among university students: A pilot randomized controlled trial.,"OBJECTIVE


Brief interventions based on personalized feedback have shown promising results in reducing risky alcohol use among university students. We investigated the effects of activating deliberative (predecisional) or implemental (postdecisional) mindsets on the effectiveness of a standardized brief intervention, the ASSIST-linked Brief Intervention. This intervention comprises a personalized feedback and a decisional balance exercise. We hypothesized that participants in a deliberative mindset should show better outcomes related to risk perception and behavior than participants in an implemental mindset.
METHODS


A sample of 257 students provided baseline measures on risk perception, readiness to change, and alcohol use. Of those, 64 students with risky alcohol use were randomly allocated to one of two mindset induction conditions-deliberative or implemental mindset. Thereafter, they received the ASSIST-linked Brief Intervention and completed self-report questionnaires on changes in risk perception, alcohol use, and readiness to change at post-intervention and four-week follow-up.
RESULTS


In contrast to our hypotheses, the four-weeks follow-up revealed that participants in the implemental mindset consumed significantly less alcohol than participants in a deliberative mindset did. The former decreased and the latter increased their alcohol intake; resistance to the brief intervention was stronger in the latter condition. However, neither deliberative nor implemental mindset participants showed any changes in risk perceptions or in their readiness to change alcohol consumption.
CONCLUSIONS


These findings suggest that mindset induction is a powerful moderator of the effects of the ASSIST-linked Brief Intervention. We argue that systematic research on mindset effects on brief intervention techniques aimed to reduce risky alcohol use is highly needed in order to identify the processes involved with commitment and resistance being the main candidates.",2020,"However, neither deliberative nor implemental mindset participants showed any changes in risk perceptions or in their readiness to change alcohol consumption.
","['64 students with risky alcohol use', '257 students', 'university students']","['activating deliberative (predecisional) or implemental (postdecisional) mindsets', 'mindset induction conditions-deliberative or implemental mindset']","['risk perceptions', 'alcohol intake; resistance', 'risk perception and behavior', 'risk perception, readiness to change, and alcohol use', 'risk perception']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",257.0,0.0171764,"However, neither deliberative nor implemental mindset participants showed any changes in risk perceptions or in their readiness to change alcohol consumption.
","[{'ForeName': 'Natascha', 'Initials': 'N', 'LastName': 'Büchele', 'Affiliation': 'Department of Psychology, University of Konstanz, Konstanz, Germany.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Keller', 'Affiliation': 'Department of Psychology, University of Konstanz, Konstanz, Germany.'}, {'ForeName': 'Anja C', 'Initials': 'AC', 'LastName': 'Zeller', 'Affiliation': 'Department of Psychology, University of Konstanz, Konstanz, Germany.'}, {'ForeName': 'Freya', 'Initials': 'F', 'LastName': 'Schrietter', 'Affiliation': 'Department of Psychology, University of Konstanz, Konstanz, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Treiber', 'Affiliation': 'Department of Psychology, University of Konstanz, Konstanz, Germany.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Gollwitzer', 'Affiliation': 'Department of Psychology, University of Konstanz, Konstanz, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Odenwald', 'Affiliation': 'Department of Psychology, University of Konstanz, Konstanz, Germany.'}]",PloS one,['10.1371/journal.pone.0238833']
2760,32945261,A Mobile Social Network-Based Smoking Cessation Intervention for Chinese Male Smokers: Protocol for a Pilot Randomized Controlled Trial.,"BACKGROUND


Approximately 2 million Chinese people die annually from tobacco-related diseases, mostly men; yet, fewer than 8% of Chinese smokers ever receive any smoking cessation advice or support. A social network-based gamified smoking cessation intervention (SCAMPI: Smoking Cessation App for Chinese Male: Pilot Intervention) is designed to help Chinese male smokers to quit smoking.
OBJECTIVE


This paper aims to present the protocol of a study examining the preliminary effectiveness of SCAMPI by comparing the prolonged abstinence rate of a group of users with a comparator group during a 6-week follow-up period.
METHODS


A two-arm pilot randomized controlled trial was conducted to assess the preliminary effectiveness and acceptability of the SCAMPI program as a smoking cessation intervention. After initial web-based screening, the first 80 eligible individuals who had gone through the required registration process were registered as participants of the trial. Participants were randomly allocated to the intervention group (n=40) and the control group (n=40). Participants in the intervention group used the full version of the SCAMPI program, which is a Chinese smoking cessation program developed based on the Behavior Change Wheel framework and relevant smoking cessation and design guidelines with involvement of target users. The program delivers a range of smoking cessation approaches, including helping users to make quitting plans, calculator to record quitting benefits, calendar to record progress, gamification to facilitate quitting, providing information about smoking harms, motivational messages to help users overcome urges, providing standardized tests to users for assessing their levels of nicotine dependence and lung health, and providing a platform to encourage social support between users. Participants in the control group used the restricted version of the SCAMPI program (placebo app).
RESULTS


Recruitment for this project commenced in January 2019 and proceeded until March 2019. Follow-up data collection was commenced and completed by June 2019. The primary outcome measure of the study was the 30-day bio-verified smoking abstinence at the 6-week follow-up (self-reported data verified by the Nicotine Cotinine Saliva Test). The secondary outcome measures of the study included participants' cigarette consumption reduction (compared baseline daily cigarette consumption with end-of-trial daily cigarette consumption), participants' 7-day smoking abstinence at 4-week and 6-week follow-up (self-reported), participants' 30-day smoking abstinence at 6-week follow-up (self-reported data only), and participants' acceptability and satisfaction levels of using the SCAMPI program (measured by the Mobile App Rating Scale questionnaire).
CONCLUSIONS


If the SCAMPI program is shown to be preliminary effective, the study will be rolled out to be a future trial with a larger sample size and longer follow-up (6 months) to identify if it is an effective social network-based tool to support Chinese male smokers to quit smoking.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry ACTRN12618001089224; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=375381.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


RR1-10.2196/18071.",2020,"Participants in the intervention group used the full version of the SCAMPI program, which is a Chinese smoking cessation program developed based on the Behavior Change Wheel framework and relevant smoking cessation and design guidelines with involvement of target users.","['Chinese Male', '80 eligible individuals who had gone through the required registration process were registered as participants of the trial', 'Chinese male smokers to quit smoking', 'Chinese Male Smokers', 'Approximately 2 million Chinese people die annually from tobacco-related diseases, mostly men']","['Mobile Social Network-Based Smoking Cessation Intervention', 'SCAMPI program', 'social network-based gamified smoking cessation intervention (SCAMPI: Smoking Cessation App', 'Chinese smoking cessation program developed based on the Behavior Change Wheel framework and relevant smoking cessation and design guidelines with involvement of target users', 'SCAMPI program (placebo app', 'SCAMPI']","[""participants' cigarette consumption reduction (compared baseline daily cigarette consumption with end-of-trial daily cigarette consumption), participants' 7-day smoking abstinence"", '30-day smoking abstinence', '30-day bio-verified smoking abstinence at the 6-week follow-up (self-reported data verified by the Nicotine Cotinine Saliva Test', ""participants' acceptability and satisfaction levels of using the SCAMPI program (measured by the Mobile App Rating Scale questionnaire""]","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C1881839', 'cui_str': '1000000'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0453056', 'cui_str': 'Scampi'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1692317', 'cui_str': 'Smoking cessation assistance'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0459840', 'cui_str': 'Cigarette consumption'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0010194', 'cui_str': 'Cotinine'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0453056', 'cui_str': 'Scampi'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.0757957,"Participants in the intervention group used the full version of the SCAMPI program, which is a Chinese smoking cessation program developed based on the Behavior Change Wheel framework and relevant smoking cessation and design guidelines with involvement of target users.","[{'ForeName': 'Jinsong', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'The National Institute for Health Innovation, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Elsie', 'Initials': 'E', 'LastName': 'Ho', 'Affiliation': 'School of Population Health, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Yannan', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'The National Institute for Health Innovation, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Robyn', 'Initials': 'R', 'LastName': 'Whittaker', 'Affiliation': 'The National Institute for Health Innovation, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Tingzhong', 'Initials': 'T', 'LastName': 'Yang', 'Affiliation': 'Centre for Tobacco Control Research, School of Medicine, The Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Bullen', 'Affiliation': 'The National Institute for Health Innovation, The University of Auckland, Auckland, New Zealand.'}]",JMIR research protocols,['10.2196/18071']
2761,32941439,"""What you say and how you say it"" matters: An experimental evidence of the role of synchronicity, modality, and message valence during smartphone-mediated communication.","Nowadays, smartphone-Mediated Communication (SMC) has become a popular form of social interactions. The present experimental study manipulated three aspects of messaging in a WhatsApp chat as a form of SMC: synchronicity (immediate vs. time-lagged response), modality (with or without emojis), and valence (empathic accurate vs. empathic inaccurate response). The aim of this study was to investigate whether these three aspects had an impact on perceived social support, interpersonal trust, and personality attribution of the communication partner. The partial mediation of perceived social presence (the evaluation of the communication partner's accessibility) and subjective social presence (the perception of being concordant with him/her) was also examined. Participants were 160 young adults, balanced in gender. They were randomly assigned to different the experimental conditions where they engaged in a manipulated WhatsApp chat with a fictitious same-gender communication partner. Post-questionnaire data were analyzed using Structural Equation Modeling. Message valence (empathic accurate response) and modality (with emojis) significantly predicted higher levels of both forms of social presence. Synchronicity (immediate response) predicted higher levels of perceived but not subjective social presence. Social presence, in turn, was positively associated with social support, while subjective, but not perceived social presence, was positively associated with personality attribution. Neither perceived nor subjective social presence were related to interpersonal trust. Our results show that both what is said and how it is said impact the experience of interpersonal relations in SMC.",2020,Message valence (empathic accurate response) and modality (with emojis) significantly predicted higher levels of both forms of social presence.,"['Participants were 160 young adults, balanced in gender']",['smartphone-Mediated Communication (SMC'],"['Message valence (empathic accurate response', 'subjective social presence', 'perceived social support, interpersonal trust, and personality attribution of the communication partner']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0079399', 'cui_str': 'Gender'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0009452', 'cui_str': 'Communication'}]","[{'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0003944', 'cui_str': 'As If Personality'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}]",160.0,0.0152429,Message valence (empathic accurate response) and modality (with emojis) significantly predicted higher levels of both forms of social presence.,"[{'ForeName': 'Serena', 'Initials': 'S', 'LastName': 'Petrocchi', 'Affiliation': 'Faculty of Communication, Culture and Society, Università della Svizzera italiana, Lugano, Switzerland.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Marciano', 'Affiliation': 'Faculty of Communication, Culture and Society, Università della Svizzera italiana, Lugano, Switzerland.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Annoni', 'Affiliation': 'Faculty of Communication, Culture and Society, Università della Svizzera italiana, Lugano, Switzerland.'}, {'ForeName': 'Anne-Linda', 'Initials': 'AL', 'LastName': 'Camerini', 'Affiliation': 'Faculty of Communication, Culture and Society, Università della Svizzera italiana, Lugano, Switzerland.'}]",PloS one,['10.1371/journal.pone.0237846']
2762,32941462,Provider anticipation and experience of patient reaction when deprescribing guideline discordant inhaled corticosteroids.,"INTRODUCTION


Despite evidence of possible patient harm and substantial costs, medication overuse is persistent. Patient reaction is one potential barrier to deprescribing, but little research has assessed this in specific instances of medication discontinuation. We sought to understand Veteran and provider experience when de-implementing guideline-discordant use of inhaled corticosteroids (ICS) in those with mild-to-moderate chronic obstructive pulmonary disease (COPD).
METHODS


We conducted a mixed-methods analysis in a provider-randomized quality improvement project testing a proactive electronic-consultation from pulmonologists recommending ICS discontinuation when appropriate. PCPs at two Veterans Health Administration healthcare systems were included. We completed interviews with 16 unexposed providers and 6 intervention-exposed providers. We interviewed 9 patients within 3 months after their PCP proposed ICS discontinuation. We conducted inductive and deductive content analysis of qualitative data to explore an emergent theme of patient reaction. Forty-eight PCPs returned surveys (24 exposed and 24 unexposed, response rate: 35%).
RESULTS


The unexposed providers anticipated their patients might resist ICS discontinuation because it seems counterintuitive to stop something that is working, patient's fear of worsening symptoms, or if the prescription was initiated by another provider. Intervention-exposed providers reported similar experiences in post-intervention interviews. Unexposed providers anticipated that patients may accept ICS discontinuation, citing tactical use of patient-centered care strategies. This was echoed by intervention-exposed providers who had successfully discontinued an ICS. Veterans reported acceding to their providers out of trust or deference to their advanced training, even after describing an ICS as a 'security blanket'. Our survey findings supported the subthemes from our interviews. Among providers who proposed discontinuation of an ICS, 76% reported that they were able to discontinue it or switch to another more appropriate medication.
CONCLUSIONS


While PCPs anticipated that patients would resist discontinuing an ICS, interviews with patient and intervention-exposed PCPs along with surveys suggest that patients were receptive to this change.",2020,"Unexposed providers anticipated that patients may accept ICS discontinuation, citing tactical use of patient-centered care strategies.","['16 unexposed providers and 6 intervention-exposed providers', 'those with mild-to-moderate chronic obstructive pulmonary disease (COPD']",['inhaled corticosteroids (ICS'],[],"[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]",[],9.0,0.0455836,"Unexposed providers anticipated that patients may accept ICS discontinuation, citing tactical use of patient-centered care strategies.","[{'ForeName': 'Toral J', 'Initials': 'TJ', 'LastName': 'Parikh', 'Affiliation': 'Seattle-Denver Center of Innovation for Veteran-Centered & Value-Driven Care, VA Puget Sound Healthcare System, Seattle, Washington, United States of America.'}, {'ForeName': 'Krysttel C', 'Initials': 'KC', 'LastName': 'Stryczek', 'Affiliation': 'VA Northeast Ohio Healthcare System, Cleveland, Ohio, United States of America.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Gillespie', 'Affiliation': 'Center for Healthcare Organization & Implementation Research, Edith Nourse Rogers Memorial Veterans Hospital, Bedford, Massachusetts, United States of America.'}, {'ForeName': 'George G', 'Initials': 'GG', 'LastName': 'Sayre', 'Affiliation': 'Seattle-Denver Center of Innovation for Veteran-Centered & Value-Driven Care, VA Puget Sound Healthcare System, Seattle, Washington, United States of America.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Feemster', 'Affiliation': 'Seattle-Denver Center of Innovation for Veteran-Centered & Value-Driven Care, VA Puget Sound Healthcare System, Seattle, Washington, United States of America.'}, {'ForeName': 'Edmunds', 'Initials': 'E', 'LastName': 'Udris', 'Affiliation': 'Seattle-Denver Center of Innovation for Veteran-Centered & Value-Driven Care, VA Puget Sound Healthcare System, Seattle, Washington, United States of America.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Majerczyk', 'Affiliation': 'Seattle-Denver Center of Innovation for Veteran-Centered & Value-Driven Care, VA Puget Sound Healthcare System, Seattle, Washington, United States of America.'}, {'ForeName': 'Seppo T', 'Initials': 'ST', 'LastName': 'Rinne', 'Affiliation': 'Center for Healthcare Organization & Implementation Research, Edith Nourse Rogers Memorial Veterans Hospital, Bedford, Massachusetts, United States of America.'}, {'ForeName': 'Renda Soylemez', 'Initials': 'RS', 'LastName': 'Wiener', 'Affiliation': 'Center for Healthcare Organization & Implementation Research, Edith Nourse Rogers Memorial Veterans Hospital, Bedford, Massachusetts, United States of America.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Au', 'Affiliation': 'Seattle-Denver Center of Innovation for Veteran-Centered & Value-Driven Care, VA Puget Sound Healthcare System, Seattle, Washington, United States of America.'}, {'ForeName': 'Christian D', 'Initials': 'CD', 'LastName': 'Helfrich', 'Affiliation': 'Seattle-Denver Center of Innovation for Veteran-Centered & Value-Driven Care, VA Puget Sound Healthcare System, Seattle, Washington, United States of America.'}]",PloS one,['10.1371/journal.pone.0238511']
2763,32941476,A randomized pilot trial to evaluate the benefit of the concomitant use of atorvastatin and Raltegravir on immunological markers in protease-inhibitor-treated subjects living with HIV.,"OBJECTIVE


Optimization of antiretroviral therapy and anti-inflammatory treatments, such as statins, are among the strategies aimed at reducing metabolic disorders, inflammation and immune activation in people living with HIV (PLWH). We evaluated the potential benefit of combining both strategies.
DESIGN


Forty-two PLWH aged ≥40 years receiving a protease inhibitor (PI)-based regimen were randomized (1:1) to switch from PI to Raltegravir (n = 20), or to remain on PI (n = 22). After 24 weeks, all patients received atorvastatin 20mg/day for 48 weeks.
METHODS


We analyzed plasma inflammatory as well as T-cell maturation, activation, exhaustion and senescence markers at baseline, 24 and 72 weeks.
RESULTS


Plasma inflammatory markers remained unchanged. Furthermore, no major changes on T-cell maturation subsets, immunoactivation, exhaustion or immunosenescence markers in both CD4 and CD8 T cell compartments were observed. Only a modest decrease in the frequency of CD38+ CD8 T cells and an increase in the frequency of CD28-CD57+ in both CD4 and CD8 T-cell compartments were noticed in the Raltegravir-switched group.
CONCLUSIONS


The study combined antiretroviral switch to Raltegravir and Statin-based anti-inflammatory strategies to reduce inflammation and chronic immune activation in PLWH. Although this combination was safe and well tolerated, it had minimal impact on inflammatory and immunological markers.
CLINICAL TRIALS REGISTRATION


NCT02577042.",2020,"Furthermore, no major changes on T-cell maturation subsets, immunoactivation, exhaustion or immunosenescence markers in both CD4 and CD8 T cell compartments were observed.","['Forty-two PLWH aged ≥40 years receiving a protease inhibitor (PI)-based regimen', 'protease-inhibitor-treated subjects living with HIV', 'people living with HIV (PLWH']","['atorvastatin and Raltegravir', 'Raltegravir and Statin-based anti-inflammatory strategies', 'atorvastatin', 'Raltegravir']","['T-cell maturation, activation, exhaustion and senescence markers', 'safe and well tolerated', 'frequency of CD28-CD57+ in both CD4 and CD8 T-cell compartments', 'frequency of CD38+ CD8 T cells', 'T-cell maturation subsets, immunoactivation, exhaustion or immunosenescence markers in both CD4 and CD8 T cell compartments']","[{'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0033607', 'cui_str': 'Peptide hydrolase inhibitor'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C1871526', 'cui_str': 'raltegravir'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}]","[{'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0231337', 'cui_str': 'Senility'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0075747', 'cui_str': 'Lymphocyte antigen CD28'}, {'cui': 'C0054965', 'cui_str': 'Lymphocyte antigen CD57'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C0075742', 'cui_str': 'Lymphocyte antigen CD38'}, {'cui': 'C0596761', 'cui_str': 'Immunosenescence'}]",,0.0296761,"Furthermore, no major changes on T-cell maturation subsets, immunoactivation, exhaustion or immunosenescence markers in both CD4 and CD8 T cell compartments were observed.","[{'ForeName': 'Eugènia', 'Initials': 'E', 'LastName': 'Negredo', 'Affiliation': 'Lluita Contra la SIDA Foundation, Germans Trias i Pujol Research Institute-IGTP, Hospital Universitari Germans Trias i Pujol, Universitat Autònoma de Barcelona, Badalona, Catalonia, Spain.'}, {'ForeName': 'Montse', 'Initials': 'M', 'LastName': 'Jiménez', 'Affiliation': 'AIDS Research Institute-IrsiCaixa, Germans Trias i Pujol Research Institute-IGTP, Hospital Universitari Germans Trias i Pujol, Barcelona, Catalonia, Spain.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Puig', 'Affiliation': 'Lluita Contra la SIDA Foundation, Germans Trias i Pujol Research Institute-IGTP, Hospital Universitari Germans Trias i Pujol, Universitat Autònoma de Barcelona, Badalona, Catalonia, Spain.'}, {'ForeName': 'Cora', 'Initials': 'C', 'LastName': 'Loste', 'Affiliation': 'Lluita Contra la SIDA Foundation, Germans Trias i Pujol Research Institute-IGTP, Hospital Universitari Germans Trias i Pujol, Universitat Autònoma de Barcelona, Badalona, Catalonia, Spain.'}, {'ForeName': 'Núria', 'Initials': 'N', 'LastName': 'Pérez-Álvarez', 'Affiliation': 'Lluita Contra la SIDA Foundation, Germans Trias i Pujol Research Institute-IGTP, Hospital Universitari Germans Trias i Pujol, Universitat Autònoma de Barcelona, Badalona, Catalonia, Spain.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Urrea', 'Affiliation': 'AIDS Research Institute-IrsiCaixa, Germans Trias i Pujol Research Institute-IGTP, Hospital Universitari Germans Trias i Pujol, Barcelona, Catalonia, Spain.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Echeverría', 'Affiliation': 'Lluita Contra la SIDA Foundation, Germans Trias i Pujol Research Institute-IGTP, Hospital Universitari Germans Trias i Pujol, Universitat Autònoma de Barcelona, Badalona, Catalonia, Spain.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Bonjoch', 'Affiliation': 'Lluita Contra la SIDA Foundation, Germans Trias i Pujol Research Institute-IGTP, Hospital Universitari Germans Trias i Pujol, Universitat Autònoma de Barcelona, Badalona, Catalonia, Spain.'}, {'ForeName': 'Bonaventura', 'Initials': 'B', 'LastName': 'Clotet', 'Affiliation': 'Lluita Contra la SIDA Foundation, Germans Trias i Pujol Research Institute-IGTP, Hospital Universitari Germans Trias i Pujol, Universitat Autònoma de Barcelona, Badalona, Catalonia, Spain.'}, {'ForeName': 'Julià', 'Initials': 'J', 'LastName': 'Blanco', 'Affiliation': 'Infectious Diseases and Immunity, Centre for Health and Social Care Research (CESS), Faculty of Medicine, University of Vic-Central University of Catalonia (UVic-UCC), Catalonia, Spain.'}]",PloS one,['10.1371/journal.pone.0238575']
2764,32948514,Self-administration of adrenaline for anaphylaxis during in-hospital food challenges improves health-related quality of life.,"OBJECTIVE


To assess the impact of anaphylaxis on health-related quality of life (HRQL) and self-efficacy in food-allergic patients undergoing in-hospital food challenge.
DESIGN


Secondary analysis of a randomised controlled trial.
SETTING


Specialist allergy centre.
PATIENTS


Peanut-allergic young people aged 8-16 years.
INTERVENTIONS


Double-blind, placebo-controlled food challenge to peanut, with HRQL and self-efficacy assessed using validated questionnaire, approximately 2 weeks prior to and 2 weeks after challenge. Where possible, anaphylaxis was treated with self-injected adrenaline (epinephrine).
MAIN OUTCOME MEASURES


Change in HRQL and self-efficacy.
RESULTS


56 participants had reactions at food challenge, of whom 16 (29%) had anaphylaxis. Overall, there was an improvement in HRQL (mean 2.6 points (95% CI 0.3 to 4.8); p=0.030) and self-efficacy (mean 4.1 points (95% CI 2.4 to 5.9); p<0.0001), independent of whether anaphylaxis occurred. Parents also reported improved HRQL (mean 10.3 points (95% CI 5.9 to 14.7); p<0.0001). We found evidence of discordance between the improvement in HRQL and self-efficacy as reported by young people and that perceived by parents in their child.
CONCLUSIONS


Anaphylaxis at food challenge, followed by self-administration of injected adrenaline, was associated with an increase in HRQL and self-efficacy in young people with peanut allergy. We found no evidence that the occurrence of anaphylaxis had a detrimental effect. Young people should be encouraged to self-administer adrenaline using their autoinjector device to treat anaphylaxis at in-hospital challenge.
TRIAL REGISTRATION NUMBER


NCT02149719.",2020,Parents also reported improved HRQL,"['food-allergic patients undergoing in-hospital food challenge', 'young people with peanut allergy', '56 participants had reactions at food challenge, of whom 16 (29%) had anaphylaxis', 'Peanut-allergic young people aged 8-16 years', 'Specialist allergy centre', 'Young people']","['adrenaline (epinephrine', 'placebo-controlled food challenge to peanut, with HRQL', 'adrenaline']","['health-related quality of life', 'HRQL and self-efficacy', 'self-efficacy', 'HRQL', 'health-related quality of life (HRQL) and self-efficacy']","[{'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0559470', 'cui_str': 'Allergy to peanut'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0002792', 'cui_str': 'Anaphylaxis'}, {'cui': 'C0030736', 'cui_str': 'Arachis hypogaea'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0002111', 'cui_str': 'Allergy - specialty'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0030736', 'cui_str': 'Arachis hypogaea'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",,0.386454,Parents also reported improved HRQL,"[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Burrell', 'Affiliation': 'Section of Inflammation, Repair and Development, National Heart & Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'Nandinee', 'Initials': 'N', 'LastName': 'Patel', 'Affiliation': 'Section of Inflammation, Repair and Development, National Heart & Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Vazquez-Ortiz', 'Affiliation': 'Section of Inflammation, Repair and Development, National Heart & Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'Dianne E', 'Initials': 'DE', 'LastName': 'Campbell', 'Affiliation': 'Discipline of Child and Adolescent Health, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'DunnGalvin', 'Affiliation': 'School of Applied Psychology, Department of Paediatrics and Child Health, University College Cork, Cork, Ireland.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Turner', 'Affiliation': 'Section of Inflammation, Repair and Development, National Heart & Lung Institute, Imperial College London, London, UK p.turner@imperial.ac.uk.'}]",Archives of disease in childhood,['10.1136/archdischild-2020-319906']
2765,32946574,Pharmacodynamic Activity of the Novel Neurokinin-3 Receptor Antagonist SJX-653 in Healthy Men.,"CONTEXT


SJX-653 is a novel neurokinin 3 receptor (NK3R) antagonist. The NK3 pathway is a central regulator of gonadotropin releasing hormone (GnRH) secretion and has also been implicated in the generation of hot flashes. Therefore, decreases of luteinizing hormone (LH) and testosterone in men serve as sensitive pharmacodynamic (PD) markers of central NK3 antagonism.
OBJECTIVE


To characterize the safety, tolerability, pharmacokinetics, and pharmacodynamic activity of SJX-653 in healthy men.
DESIGN


A randomized, placebo-controlled, double-blind, single ascending dose study.
SETTING


Phase 1 unit.
PATIENTS OR OTHER PARTICIPANTS


Seven cohorts of 6 healthy men 18-45 years of age (4:2 randomization to SJX-653/placebo per cohort).
INTERVENTION(S)


Single oral doses of 0.5-90 mg SJX-653.
MAIN OUTCOME MEASURE(S)


Safety assessments and serial pharmacokinetic (PK)/PD measurements.
RESULTS


SJX-653 was well tolerated at all dose levels. Cmax and AUC0-24 increased in a dose-proportional manner. The terminal elimination half-life ranged between 9.8 and 12.5 hours independent of dose. A statistically significant, dose-dependent, reversible reduction of LH and testosterone was observed with near maximal effect after 15 mg and little to no effect at 4.5 mg. Maximal LH reduction was 70 ± 7% (mean ± sd) at 6 hours after 30 mg SJX-653 versus 10 ± 43% for placebo (P = 0.0006); maximal T reduction was of 68 ± 5% at 8 hours after 60 mg SJX-653 versus 18 ± 11% for placebo (P < 0.0001). The plasma IC50 for LH reduction was 33 ng/mL.
CONCLUSIONS


These data demonstrate clinical proof-of-mechanism for SJX-653 as a potent centrally-acting NK3R antagonist.",2020,"A statistically significant, dose-dependent, reversible reduction of LH and testosterone was observed with near maximal effect after 15 mg and little to no effect at 4.5 mg.","['Phase 1 unit', 'healthy men', 'Seven cohorts of 6 healthy men 18-45 years (4:2 randomization to SJX-653/placebo per cohort']","['placebo', 'SJX-653', 'novel neurokinin-3 receptor antagonist SJX-653']","['LH and testosterone', 'Safety assessments and serial Pharmacokinetic (PK)/PD measurements', 'Maximal LH reduction', 'plasma IC50 for LH reduction', 'Pharmacodynamic activity', 'Cmax and AUC0-24', 'tolerated', 'safety, tolerability, pharmacokinetics, and pharmacodynamic activity', 'maximal T reduction']","[{'cui': 'C0439559', 'cui_str': 'Phase 1'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0068603', 'cui_str': 'Neuromedin K Receptor'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}]","[{'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0600495', 'cui_str': 'IC50'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",6.0,0.170922,"A statistically significant, dose-dependent, reversible reduction of LH and testosterone was observed with near maximal effect after 15 mg and little to no effect at 4.5 mg.","[{'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Anderson', 'Affiliation': 'MRC Centre for Reproductive Health, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Cormier', 'Affiliation': 'Sojournix, Inc., Waltham, Massachusetts.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Thieroff-Ekerdt', 'Affiliation': 'Sojournix, Inc., Waltham, Massachusetts.'}, {'ForeName': 'Malcolm', 'Initials': 'M', 'LastName': 'Boyce', 'Affiliation': 'Hammersmith Medicines Research, London, UK.'}, {'ForeName': 'Frans', 'Initials': 'F', 'LastName': 'van den Berg', 'Affiliation': 'Hammersmith Medicines Research, London, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Grau', 'Affiliation': 'Sojournix, Inc., Waltham, Massachusetts.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Turnquist', 'Affiliation': 'Sojournix, Inc., Waltham, Massachusetts.'}, {'ForeName': 'Deya', 'Initials': 'D', 'LastName': 'Corzo', 'Affiliation': 'Sojournix, Inc., Waltham, Massachusetts.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Graham', 'Affiliation': 'Sojournix, Inc., Waltham, Massachusetts.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa657']
2766,32947480,"The 11th Trial of a Cardiovascular Clinical Trialist - Coronavirus-2, Part 3.",,2020,,[],[],[],[],[],[],,0.0214642,,"[{'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Frishman', 'Affiliation': 'Department of Medicine, New York Medical College/Westchester Medical Center, Valhalla, NY.'}]",Cardiology in review,['10.1097/CRD.0000000000000349']
2767,32947920,"The Influence of Cyclical Ketogenic Reduction Diet vs. Nutritionally Balanced Reduction Diet on Body Composition, Strength, and Endurance Performance in Healthy Young Males: A Randomized Controlled Trial.","(1) Background: The influence of ketogenic diet on physical fitness remains controversial. We performed a randomized controlled trial to compare the effect of cyclical ketogenic reduction diet (CKD) vs. nutritionally balanced reduction diet (RD) on body composition, muscle strength, and endurance performance. (2) Methods: 25 healthy young males undergoing regular resistance training combined with aerobic training were randomized to CKD ( n  = 13) or RD ( n  = 12). Body composition, muscle strength and spiroergometric parameters were measured at baseline and after eight weeks of intervention. (3) Results: Both CKD and RD decreased body weight, body fat, and BMI. Lean body mass and body water decreased in CKD and did not significantly change in RD group. Muscle strength parameters were not affected in CKD while in RD group lat pull-down and leg press values increased. Similarly, endurance performance was not changed in CKD group while in RD group peak workload and peak oxygen uptake increased. (4) Conclusions: Our data show that in healthy young males undergoing resistance and aerobic training comparable weight reduction were achieved by CKD and RD. In RD group; improved muscle strength and endurance performance was noted relative to neutral effect of CKD that also slightly reduced lean body mass.",2020,Muscle strength parameters were not affected in CKD while in RD group lat pull-down and leg press values increased.,"['25 healthy young males undergoing', 'Healthy Young Males', 'healthy young males']","['Cyclical Ketogenic Reduction Diet vs. Nutritionally Balanced Reduction Diet', 'regular resistance training combined with aerobic training', 'cyclical ketogenic reduction diet (CKD) vs. nutritionally balanced reduction diet (RD', 'ketogenic diet', 'CKD']","['Body Composition, Strength, and Endurance Performance', 'Body composition, muscle strength and spiroergometric parameters', 'peak workload and peak oxygen uptake', 'lean body mass', 'Muscle strength parameters', 'weight reduction', 'endurance performance', 'muscle strength and endurance performance', 'body composition, muscle strength, and endurance performance', 'Lean body mass and body water decreased in CKD', 'body weight, body fat, and BMI']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0439596', 'cui_str': 'Cyclic'}, {'cui': 'C0012167', 'cui_str': 'Weight reduction diet'}, {'cui': 'C0205415', 'cui_str': 'Balanced'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0259972', 'cui_str': 'Ketogenic diet'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0005909', 'cui_str': 'Body water'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0439596', 'cui_str': 'Cyclic'}, {'cui': 'C0012167', 'cui_str': 'Weight reduction diet'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",25.0,0.026568,Muscle strength parameters were not affected in CKD while in RD group lat pull-down and leg press values increased.,"[{'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Kysel', 'Affiliation': 'Department of Sports Medicine, First Faculty of Medicine and General University Hospital, 12000 Prague, Czech Republic.'}, {'ForeName': 'Denisa', 'Initials': 'D', 'LastName': 'Haluzíková', 'Affiliation': 'Department of Sports Medicine, First Faculty of Medicine and General University Hospital, 12000 Prague, Czech Republic.'}, {'ForeName': 'Radka Petráková', 'Initials': 'RP', 'LastName': 'Doležalová', 'Affiliation': 'Department of Sports Medicine, First Faculty of Medicine and General University Hospital, 12000 Prague, Czech Republic.'}, {'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Laňková', 'Affiliation': 'Centre for Experimental Medicine, Institute for Clinical and Experimental Medicine, 12000 Prague, Czech Republic.'}, {'ForeName': 'Zdeňka', 'Initials': 'Z', 'LastName': 'Lacinová', 'Affiliation': 'Centre for Experimental Medicine, Institute for Clinical and Experimental Medicine, 12000 Prague, Czech Republic.'}, {'ForeName': 'Barbora Judita', 'Initials': 'BJ', 'LastName': 'Kasperová', 'Affiliation': 'Diabetes Centre, Institute for Clinical and Experimental Medicine, 12000 Prague, Czech Republic.'}, {'ForeName': 'Jaroslava', 'Initials': 'J', 'LastName': 'Trnovská', 'Affiliation': 'Centre for Experimental Medicine, Institute for Clinical and Experimental Medicine, 12000 Prague, Czech Republic.'}, {'ForeName': 'Viktorie', 'Initials': 'V', 'LastName': 'Hrádková', 'Affiliation': 'Diabetes Centre, Institute for Clinical and Experimental Medicine, 12000 Prague, Czech Republic.'}, {'ForeName': 'Miloš', 'Initials': 'M', 'LastName': 'Mráz', 'Affiliation': 'Diabetes Centre, Institute for Clinical and Experimental Medicine, 12000 Prague, Czech Republic.'}, {'ForeName': 'Zdeněk', 'Initials': 'Z', 'LastName': 'Vilikus', 'Affiliation': 'Department of Sports Medicine, First Faculty of Medicine and General University Hospital, 12000 Prague, Czech Republic.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Haluzík', 'Affiliation': 'Diabetes Centre, Institute for Clinical and Experimental Medicine, 12000 Prague, Czech Republic.'}]",Nutrients,['10.3390/nu12092832']
2768,32928957,Diabetic Ketoacidosis and Related Events With Sotagliflozin Added to Insulin in Adults With Type 1 Diabetes: A Pooled Analysis of the inTandem 1 and 2 Studies.,"OBJECTIVE


To evaluate the incidence and risk factors for diabetic ketoacidosis (DKA) and related adverse events (AEs) in adults with type 1 diabetes treated with sotagliflozin adjunctive to insulin.
RESEARCH DESIGN AND METHODS


Data from two identically designed, 52-week, randomized studies were pooled and analyzed for DKA, changes in β-hydroxybutyrate (BHB), and percentage of patients with BHB >0.6 and >1.5 mmol/L. The patients were administered placebo, sotagliflozin 200 mg, or sotagliflozin 400 mg once daily.
RESULTS


A total of 191 ketosis-related AEs were reported, and 98 underwent adjudication. Of these, 37 events (36 patients) were adjudicated as DKA, with an exposure-adjusted incidence rate of 0.2, 3.1, and 4.2 events per 100 patient-years for placebo, sotagliflozin 200 mg, and sotagliflozin 400 mg, respectively. No patient died of a DKA event. From a baseline BHB of ∼0.13 mmol/L, sotagliflozin treatment led to a small median increase over 52 weeks (≤0.05 mmol/L at all time points). Of sotagliflozin-treated patients, approximately 47% and 7% had ≥1 BHB measurement >0.6 mmol/L and >1.5 mmol/L, respectively (vs. 20% and 2%, respectively, of placebo-treated patients). Subsequent to the implementation of a risk mitigation plan, annualized DKA incidence was lower versus preimplementation in both the sotagliflozin 200 and 400 mg groups.
CONCLUSIONS


In patients with type 1 diabetes, confirmed DKA incidence increased when sotagliflozin was added to insulin compared with insulin alone. A lower incidence of DKA was observed following the implementation of an enhanced risk mitigation plan, suggesting that this risk can be managed with patient education.",2020,"Subsequent to the implementation of a risk mitigation plan, annualized DKA incidence was lower versus preimplementation in both the sotagliflozin 200 and 400 mg groups.
","['Adults With Type 1 Diabetes', 'adults with type 1 diabetes treated with sotagliflozin adjunctive to insulin', 'Data from two identically designed, 52-week, randomized studies were pooled and analyzed for DKA, changes in β-hydroxybutyrate (BHB), and percentage of patients with BHB >0.6 and >1.5 mmol/L', '37 events (36 patients) were adjudicated as DKA, with an exposure-adjusted incidence rate of 0.2, 3.1, and 4.2 events per 100 patient-years for']","['placebo, sotagliflozin 200 mg, and sotagliflozin 400 mg', 'placebo, sotagliflozin 200 mg, or sotagliflozin 400 mg once daily', 'Sotagliflozin', 'sotagliflozin']","['DKA incidence', 'Diabetic Ketoacidosis', 'annualized DKA incidence']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C3502471', 'cui_str': '(2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0337051', 'cui_str': 'Pool'}, {'cui': 'C0011880', 'cui_str': 'Diabetic ketoacidosis'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0020332', 'cui_str': 'Hydroxybutyrates'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4068883', 'cui_str': '0.6'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C4517683', 'cui_str': '3.1'}, {'cui': 'C4517758', 'cui_str': '4.2'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3502471', 'cui_str': '(2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}]","[{'cui': 'C0011880', 'cui_str': 'Diabetic ketoacidosis'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",,0.15226,"Subsequent to the implementation of a risk mitigation plan, annualized DKA incidence was lower versus preimplementation in both the sotagliflozin 200 and 400 mg groups.
","[{'ForeName': 'Anne L', 'Initials': 'AL', 'LastName': 'Peters', 'Affiliation': 'Keck School of Medicine of the University of Southern California, Los Angeles, CA annepete@med.usc.edu.'}, {'ForeName': 'Darren K', 'Initials': 'DK', 'LastName': 'McGuire', 'Affiliation': 'University of Texas Southwestern Medical Center at Dallas, Dallas, TX.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Danne', 'Affiliation': 'Kinder Krakenhaus auf der Bult, Diabetes Zentrum für Kinder and Jugendliche, Hannover, Germany.'}, {'ForeName': 'Jake A', 'Initials': 'JA', 'LastName': 'Kushner', 'Affiliation': 'McNair Interests, Houston, TX.'}, {'ForeName': 'Helena W', 'Initials': 'HW', 'LastName': 'Rodbard', 'Affiliation': 'Endocrine and Metabolic Consultants Research Center, Rockville, MD.'}, {'ForeName': 'Ketan', 'Initials': 'K', 'LastName': 'Dhatariya', 'Affiliation': 'Norfolk and Norwich University Hospitals National Health Service Foundation Trust, Norwich, U.K.'}, {'ForeName': 'Sangeeta', 'Initials': 'S', 'LastName': 'Sawhney', 'Affiliation': 'Lexicon Pharmaceuticals, Inc., The Woodlands, TX.'}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Banks', 'Affiliation': 'Lexicon Pharmaceuticals, Inc., The Woodlands, TX.'}, {'ForeName': 'Wenjun', 'Initials': 'W', 'LastName': 'Jiang', 'Affiliation': 'Lexicon Pharmaceuticals, Inc., The Woodlands, TX.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Davies', 'Affiliation': 'Lexicon Pharmaceuticals, Inc., The Woodlands, TX.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Lapuerta', 'Affiliation': 'Lexicon Pharmaceuticals, Inc., The Woodlands, TX.'}]",Diabetes care,['10.2337/dc20-0924']
2769,32930969,Development and Internal Validation of a Discrete Event Simulation Model of Diabetic Kidney Disease Using CREDENCE Trial Data.,"INTRODUCTION


The Canagliflozin and Renal Endpoints in Diabetes with Established Nephropathy Clinical Evaluation (CREDENCE) study showed that compared with placebo, canagliflozin 100 mg significantly reduced the risk of major cardiovascular events and adverse renal outcomes in patients with diabetic kidney disease (DKD). We developed a simulation model that can be used to estimate the long-term health and economic consequences of DKD treatment interventions for patients matching the CREDENCE study population.
METHODS


The CREDENCE Economic Model of DKD (CREDEM-DKD) was developed using patient-level data from CREDENCE (which recruited patients with estimated glomerular filtration rate 30 to < 90 mL/min/1.73 m 2 , urinary albumin to creatinine ratio > 300-5000 mg/g, and taking the maximum tolerated dose of a renin-angiotensin-aldosterone system inhibitor). Risk prediction equations were fit for start of maintenance dialysis, doubling of serum creatinine, hospitalization for heart failure, nonfatal myocardial infarction, nonfatal stroke, and all-cause mortality. A micro-simulation model was constructed using these risk equations combined with user-definable kidney transplant event risks. Internal validation was performed by loading the model to replicate the CREDENCE study and comparing predictions with trial Kaplan-Meier estimate curves. External validation was performed by loading the model to replicate a subgroup of the CANagliflozin cardioVascular Assessment Study (CANVAS) Program with patient characteristics that would have qualified for inclusion in CREDENCE.
RESULTS


Risk prediction equations generally fit well and exhibited good concordance, especially for the placebo arm. In the canagliflozin arm, modest underprediction was observed for myocardial infarction, along with overprediction of dialysis, doubling of serum creatinine, and all-cause mortality. Discrimination was strong (0.85) for the renal outcomes, but weaker for the macrovascular outcomes and all-cause mortality (0.60-0.68). The model performed well in internal and external validation exercises.
CONCLUSION


CREDEM-DKD is an important new tool in the evaluation of treatment interventions in the DKD population.
TRIAL REGISTRATION


ClinicalTrials.gov identifier, NCT02065791.",2020,"Discrimination was strong (0.85) for the renal outcomes, but weaker for the macrovascular outcomes and all-cause mortality (0.60-0.68).","['recruited patients with estimated glomerular filtration rate 30 to <\u200990\xa0mL', 'patients with diabetic kidney disease (DKD', 'patients matching the CREDENCE study population', 'Diabetic Kidney Disease']","['CREDEM', 'placebo, canagliflozin']","['myocardial infarction', 'macrovascular outcomes and all-cause mortality', 'serum creatinine, hospitalization for heart failure, nonfatal myocardial infarction, nonfatal stroke, and all-cause mortality', 'risk of major cardiovascular events and adverse renal outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0439087', 'cui_str': '<90'}, {'cui': 'C0011881', 'cui_str': 'Kidney disorder due to diabetes mellitus'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C2974540', 'cui_str': 'canagliflozin'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C1261322', 'cui_str': 'Evaluation procedure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2974540', 'cui_str': 'canagliflozin'}]","[{'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}]",,0.0330236,"Discrimination was strong (0.85) for the renal outcomes, but weaker for the macrovascular outcomes and all-cause mortality (0.60-0.68).","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Willis', 'Affiliation': 'The Swedish Institute for Health Economics, Lund, Sweden. mw@ihe.se.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Asseburg', 'Affiliation': 'ESiOR Oy, Kuopio, Finland.'}, {'ForeName': 'April', 'Initials': 'A', 'LastName': 'Slee', 'Affiliation': 'Axio Research Inc, Seattle, WA, USA.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Nilsson', 'Affiliation': 'The Swedish Institute for Health Economics, Lund, Sweden.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Neslusan', 'Affiliation': 'Janssen Scientific Affairs, LLC, Titusville, NJ, USA.'}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-020-00923-w']
2770,32925039,Metabolic and Neurocognitive Changes Following Lifestyle Modification: Examination of Biomarkers from the ENLIGHTEN Randomized Clinical Trial.,"BACKGROUND


Previous studies have demonstrated that aerobic exercise (AE) and the Dietary Approaches to Stop Hypertension (DASH) diet can improve neurocognition. However, the mechanisms by which lifestyle improves neurocognition have not been widely studied. We examined the associations between changes in metabolic, neurotrophic, and inflammatory biomarkers with executive functioning among participants from the Exercise and Nutritional Interventions for Neurocognitive Health Enhancement (ENLIGHTEN) trial.
OBJECTIVE


To examine the association between changes in metabolic function and neurocognition among older adults with cognitive impairment, but without dementia (CIND) participating in a comprehensive lifestyle intervention.
METHODS


ENLIGHTEN participants were randomized using a 2×2 factorial design to receive AE, DASH, both AE+DASH, or a health education control condition (HE) for six months. Metabolic biomarkers included insulin resistance (homeostatic model assessment [HOMA-IR]), leptin, and insulin-like growth factor (IGF-1); neurotrophic biomarkers included brain derived neurotrophic factor (BDNF) and vascular endothelial growth factor (VEGF); and inflammatory biomarkers included interleukin-6 (IL-6) and C-Reactive Protein (CRP).
RESULTS


Participants included 132 sedentary older adults (mean age = 65 [SD = 7]) with CIND. Results demonstrated that both AE (d = 0.48, p = 0.015) and DASH improved metabolic function (d = 0.37, p = 0.039), without comparable improvements in neurotrophic or inflammatory biomarkers. Greater improvements in metabolic function, including reduced HOMA-IR (B = -2.3 [-4.3, -0.2], p = 0.033) and increased IGF-1 (B = 3.4 [1.2, 5.7], p = 0.004), associated with increases in Executive Function.
CONCLUSION


Changes in neurocognition after lifestyle modification are associated with improved metabolic function.",2020,"Results demonstrated that both AE (d = 0.48, p = 0.015) and DASH improved metabolic function (d = 0.37, p = 0.039), without comparable improvements in neurotrophic or inflammatory biomarkers.","['Participants included 132 sedentary older adults (mean age\u200a=\u200a65', 'older adults with cognitive impairment, but without dementia (CIND) participating in a comprehensive lifestyle intervention', 'participants from the Exercise and Nutritional Interventions for Neurocognitive Health Enhancement (ENLIGHTEN) trial']","['aerobic exercise (AE', 'AE, DASH, both AE+DASH, or a health education control condition (HE']","['DASH improved metabolic function', 'Metabolic and Neurocognitive Changes', 'neurotrophic or inflammatory biomarkers', 'insulin resistance (homeostatic model assessment [HOMA-IR]), leptin, and insulin-like growth factor (IGF-1); neurotrophic biomarkers included brain derived neurotrophic factor (BDNF) and vascular endothelial growth factor (VEGF); and inflammatory biomarkers included interleukin-6 (IL-6) and C-Reactive Protein (CRP', 'metabolic function', 'Executive Function', 'metabolic function and neurocognition', 'IGF-1', 'reduced HOMA-IR']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C4053458', 'cui_str': 'Dietary Approaches to Stop Hypertension diet'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C4053458', 'cui_str': 'Dietary Approaches to Stop Hypertension diet'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0037657', 'cui_str': 'Somatomedin'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]",132.0,0.0789141,"Results demonstrated that both AE (d = 0.48, p = 0.015) and DASH improved metabolic function (d = 0.37, p = 0.039), without comparable improvements in neurotrophic or inflammatory biomarkers.","[{'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Smith', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Stephanie M', 'Initials': 'SM', 'LastName': 'Mabe', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Sherwood', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'P Murali', 'Initials': 'PM', 'LastName': 'Doraiswamy', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Kathleen A', 'Initials': 'KA', 'LastName': 'Welsh-Bohmer', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Burke', 'Affiliation': 'Department of Neurology, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Kraus', 'Affiliation': 'Department of Medicine, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Pao-Hwa', 'Initials': 'PH', 'LastName': 'Lin', 'Affiliation': 'Department of Medicine, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Jeffrey N', 'Initials': 'JN', 'LastName': 'Browndyke', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Babyak', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Alan L', 'Initials': 'AL', 'LastName': 'Hinderliter', 'Affiliation': 'Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Blumenthal', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, USA.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-200374']
2771,32925060,"Neuromodulation for Apathy in Alzheimer's Disease: A Double-Blind, Randomized, Sham-Controlled Pilot Study.","BACKGROUND


Apathy, a profound loss of motivation, initiation, and goal directed cognition, is a common comorbidity of Alzheimer's disease (AD). The presence of apathy is associated with rapid progression of AD, long-term impairment, disability, and higher mortality. Pharmacological treatments of apathy are limited.
OBJECTIVE


The primary objective was to evaluate the efficacy of repetitive transcranial magnetic stimulation (rTMS) for apathy in AD.
METHODS


A randomized, double-blind, parallel-arm, sham-controlled pilot study was conducted in subjects with AD and apathy (N = 20). Subjects were randomized to rTMS or sham treatment (5 days/week) for four weeks. Primary outcome, apathy evaluation scale-clinician version (AES-C), and secondary outcome measures, modified-Mini Mental State Examination (3MS), instrumental activities of daily living (IADL), and clinical global impression (CGI), were assessed at baseline and four weeks. Follow-up visits were conducted at 8 and 12 weeks to test the durability of effects of intervention.
RESULTS


Mean age was 77.3 (±7.2) years, 80% were Caucasians and 10% were females. After adjusting for baseline, there was a significantly greater improvement in the AES-C with rTMS compared to sham treatment (-10.1 (-15.9 to -4.3); t (16)  = -3.69; p = 0.002) at 4 weeks. There was also significantly greater improvement in 3MS (6.9 (1.7 to 12.0); t (15)  = 2.85; p = 0.012), IADL (3.4 (1.0 to 5.9); χ21 = 7.72; p = 0.006), CGI-S (1.4 (0.5 to 2.3), t (16)  = 3.29; p = 0.005), and CGI-I (-2.56 (-3.5 to -1.6), t (17)  = -5.72; p < 0.001) for rTMS compared to the sham at 4 weeks. The effects of rTMS were durable at 12 weeks.
CONCLUSION


rTMS may be safely used in subjects with AD and may improve apathy, function, and some aspects of cognition.",2020,"After adjusting for baseline, there was a significantly greater improvement in the AES-C with rTMS compared to sham treatment (-10.1 (-15.9 to -4.3); t (16)  = -3.69; p = 0.002) at 4 weeks.","[""Alzheimer's Disease"", 'subjects with AD and apathy (N\u200a=\u200a20', 'Mean age was 77.3 (±7.2) years, 80% were Caucasians and 10% were females', 'subjects with AD']","['rTMS', 'repetitive transcranial magnetic stimulation (rTMS']","['3MS', 'IADL', 'apathy evaluation scale-clinician version (AES-C), and secondary outcome measures, modified-Mini Mental State Examination (3MS), instrumental activities of daily living (IADL), and clinical global impression (CGI', 'CGI-S']","[{'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0085632', 'cui_str': 'Indifference'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}]","[{'cui': 'C0150641', 'cui_str': 'Instrumental activities of daily living'}, {'cui': 'C0085632', 'cui_str': 'Indifference'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}]",,0.540663,"After adjusting for baseline, there was a significantly greater improvement in the AES-C with rTMS compared to sham treatment (-10.1 (-15.9 to -4.3); t (16)  = -3.69; p = 0.002) at 4 weeks.","[{'ForeName': 'Prasad R', 'Initials': 'PR', 'LastName': 'Padala', 'Affiliation': 'Geriatric Research Education and Clinical Center, Central Arkansas Veterans Healthcare System (CAVHS), Little Rock, AR, USA.'}, {'ForeName': 'Eugenia M', 'Initials': 'EM', 'LastName': 'Boozer', 'Affiliation': 'Geriatric Research Education and Clinical Center, Central Arkansas Veterans Healthcare System (CAVHS), Little Rock, AR, USA.'}, {'ForeName': 'Shelly Y', 'Initials': 'SY', 'LastName': 'Lensing', 'Affiliation': 'Geriatric Research Education and Clinical Center, Central Arkansas Veterans Healthcare System (CAVHS), Little Rock, AR, USA.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Parkes', 'Affiliation': 'Geriatric Research Education and Clinical Center, Central Arkansas Veterans Healthcare System (CAVHS), Little Rock, AR, USA.'}, {'ForeName': 'Cassandra R', 'Initials': 'CR', 'LastName': 'Hunter', 'Affiliation': 'Geriatric Research Education and Clinical Center, Central Arkansas Veterans Healthcare System (CAVHS), Little Rock, AR, USA.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Dennis', 'Affiliation': 'Geriatric Research Education and Clinical Center, Central Arkansas Veterans Healthcare System (CAVHS), Little Rock, AR, USA.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Caceda', 'Affiliation': 'Department of Psychiatry, Stony Brook University Medical Center, Stony Brook, NY, USA.'}, {'ForeName': 'Kalpana P', 'Initials': 'KP', 'LastName': 'Padala', 'Affiliation': 'Geriatric Research Education and Clinical Center, Central Arkansas Veterans Healthcare System (CAVHS), Little Rock, AR, USA.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-200640']
2772,32925066,Can Alzheimer's Disease Be Prevented? First Evidence from Spinal Stimulation Efficacy on Executive Functions.,"BACKGROUND


Recently, a growing body of evidence has shown that, from the early stage of impairment, Alzheimer's patients (AD) present difficulties on a variety of tasks mostly relying on executive functions. These strongly impact their daily life activities causing a severe loss of independency and autonomy.
OBJECTIVE


To evaluate the efficacy of transpinal direct current stimulation (tsDCS) combined with cognitive trainings for improving attentional and executive function abilities in a group of AD patients.
METHODS


In a randomized-double blind design, sixteen AD patients underwent different cognitive trainings combined with tsDCS. During the treatment, each subject received tsDCS (20 min, 2 mA) over the thoracic vertebrae (IX-X vertebrae) in two different conditions: 1) anodal, and 2) sham while performing three computerized tasks: alertness, selective attention, and executive functions. Each experimental condition was run in ten consecutive daily sessions over two weeks.
RESULTS


After anodal tsDCS, a greater improvement in executive functions compared to sham condition was found. More importantly, the follow-up testing revealed that these effects lasted over 1 month after the intervention and generalized to the different neuropsychological tests administered before, after the treatment and at one month after the end of the intervention. This generalization was present also in the attentional domain.
CONCLUSION


This evidence emphasizes, for the first time, that tsDCS combined with cognitive training results efficacious for AD patients. We hypothesize that enhancing activity into the spinal sensorimotor pathways through stimulation improved cognitive abilities which rely on premotor activity, such as attention and executive functions.",2020,"After anodal tsDCS, a greater improvement in executive functions compared to sham condition was found.","['AD patients', 'a group of AD patients', 'sixteen AD patients']","['transpinal direct current stimulation (tsDCS) combined with cognitive trainings', 'tsDCS combined with cognitive training', 'cognitive trainings combined with tsDCS', 'anodal, and 2) sham while performing three computerized tasks: alertness, selective attention, and executive functions']","['executive functions', 'Executive Functions', 'attentional and executive function abilities']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C3715157', 'cui_str': '16'}]","[{'cui': 'C0442831', 'cui_str': 'Direct current'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0233421', 'cui_str': 'Selective inattention'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}]","[{'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",16.0,0.0954759,"After anodal tsDCS, a greater improvement in executive functions compared to sham condition was found.","[{'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Pisano', 'Affiliation': 'Department of Humanities studies - University Federico II, Naples, Italy.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Caltagirone', 'Affiliation': 'IRCCS Santa Lucia Foundation, Rome, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Satriano', 'Affiliation': 'IRCCS Santa Lucia Foundation, Rome, Italy.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Perri', 'Affiliation': 'IRCCS Santa Lucia Foundation, Rome, Italy.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Fadda', 'Affiliation': 'IRCCS Santa Lucia Foundation, Rome, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Marangolo', 'Affiliation': 'Department of Humanities studies - University Federico II, Naples, Italy.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-200695']
2773,32927285,"Open-label titration of apomorphine sublingual film in patients with Parkinson's disease and ""OFF"" episodes.","INTRODUCTION


The efficacy and safety of apomorphine sublingual film (APL-130277; APL) for the on-demand treatment of ""OFF"" episodes associated with Parkinson's disease (PD) was demonstrated in a double-blind trial. Herein we describe the ability of patients to receive effective and tolerable APL dose titration during the open-label titration phase.
METHODS


Adult patients with levodopa-responsive PD and ""OFF"" episodes were enrolled. In practically defined ""OFF,"" patients were observed for a FULL ""ON"" after their usual morning carbidopa/levodopa (CD/LD) dose and then after titration with APL following each increasing dose (10-35 mg). Antiemetic medication was administered for 3 days before initiation of titration and was continued throughout titration. Motor responses were evaluated predose and postdose using Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III score. Safety outcomes were evaluated.
RESULTS


Among 141 patients who enrolled in the study and received APL during open-label titration, 109 (77.3%) achieved a FULL ""ON"" (66.1% at 10-20 mg) and 10 did not. Patients who successfully completed APL dose titration tended to be younger, had a longer mean time since PD diagnosis, and had lower levodopa requirements than those who discontinued during titration for any reason. Change in MDS-UPDRS Part III scores from predose to 30 min postdose after titration with the effective dose of APL (n = 109) was similar across all dose groups. In a post hoc analysis, the magnitude of motor response with APL was ~2-fold higher than with CD/LD 15 min postdose, and the observed peak response occurred earlier with APL than with the trend seen for CD/LD (45 vs 90 min, respectively). Overall, the most common (≥10%) treatment-emergent adverse events (TEAEs) during APL dose titration were nausea (20.6%), yawning (12.1%), dizziness (11.3%), and somnolence (11.3%). Twelve patients discontinued due to TEAEs during APL dose titration, most commonly (≥2%) because of dizziness (2.8%), nausea (2.1%), and somnolence (2.1%).
CONCLUSION


Among eligible patients with PD and ""OFF"" episodes who had their APL dose successfully titrated to an effective and tolerable level, most were able to do so within the first 3 titrated doses but some required further dose escalations. The use of APL can provide benefit for the treatment of ""OFF"" episodes.",2020,"Overall, the most common (≥10%) treatment-emergent adverse events (TEAEs) during APL dose titration were nausea (20.6%), yawning (12.1%), dizziness (11.3%), and somnolence (11.3%).","['patients with Parkinson\'s disease and ""OFF"" episodes', '141 patients who enrolled in the study and received', 'OFF"" episodes associated with Parkinson\'s disease (PD', 'eligible patients with PD and ""OFF"" episodes who had their', 'Adult patients with levodopa-responsive PD and ""OFF"" episodes were enrolled']","['apomorphine sublingual film', 'APL', 'apomorphine sublingual film (APL-130277; APL', 'FULL ""ON']","['peak response', ""predose and postdose using Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS"", 'Change in MDS-UPDRS Part III scores', 'nausea', 'magnitude of motor response with APL', 'longer mean time since PD diagnosis', 'somnolence', 'dizziness', 'levodopa requirements']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0205342', 'cui_str': 'Responsive'}]","[{'cui': 'C0003596', 'cui_str': 'Apomorphine'}, {'cui': 'C0001565', 'cui_str': 'Sublingual route'}, {'cui': 'C1704608', 'cui_str': 'Film'}, {'cui': 'C0023487', 'cui_str': 'Acute promyelocytic leukemia'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0026650', 'cui_str': 'Movement disorder'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0449286', 'cui_str': 'Degree'}, {'cui': 'C1285623', 'cui_str': 'Motor response'}, {'cui': 'C0023487', 'cui_str': 'Acute promyelocytic leukemia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}]",141.0,0.03312,"Overall, the most common (≥10%) treatment-emergent adverse events (TEAEs) during APL dose titration were nausea (20.6%), yawning (12.1%), dizziness (11.3%), and somnolence (11.3%).","[{'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Hui', 'Affiliation': 'Keck School of Medicine of USC, University of Southern California, Los Angeles, CA, United States. Electronic address: Jennifer.hui@med.usc.edu.'}, {'ForeName': 'Susan H', 'Initials': 'SH', 'LastName': 'Fox', 'Affiliation': 'University Health Network, Toronto Western Hospital, Toronto, Ontario, Canada; Division of Neurology, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Neeson', 'Affiliation': 'Sunovion Pharmaceuticals Canada Inc., Mississauga, Ontario, Canada.'}, {'ForeName': 'Parul', 'Initials': 'P', 'LastName': 'Bhargava', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA, United States.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Pappert', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA, United States.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Blum', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA, United States.'}, {'ForeName': 'Bradford', 'Initials': 'B', 'LastName': 'Navia', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA, United States.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Parkinsonism & related disorders,['10.1016/j.parkreldis.2020.08.028']
2774,32390550,Endovascular Treatment for Acute Ischemic Stroke in Patients on Oral Anticoagulants: Results From the MR CLEAN Registry.,"Background and Purpose- The use of oral anticoagulants (OAC) is considered a contra-indication for intravenous thrombolytics as acute treatment of ischemic stroke. However, little is known about the risks and benefits of endovascular treatment in patients on prior OAC. We aim to compare outcomes after endovascular treatment between patients with and without prior use of OAC. Methods- Data of patients with acute ischemic stroke caused by an intracranial anterior circulation occlusion, included in the nationwide, prospective, MR CLEAN Registry between March 2014 and November 2017, were analyzed. Outcomes of interest included symptomatic intracranial hemorrhage and functional outcome at 90 days (modified Rankin Scale score). Outcomes between groups were compared with (ordinal) logistic regression analyses, adjusted for prognostic factors. Results- Three thousand one hundred sixty-two patients were included in this study, of whom 502 (16%) used OAC. There was no significant difference in the occurrence of symptomatic intracranial hemorrhage between patients with and without prior OACs (5% versus 6%; adjusted odds ratio, 0.63 [95% CI, 0.38-1.06]). Patients on OACs had worse functional outcomes than patients without OACs (common odds ratio, 0.57 [95% CI, 0.47-0.66]). However, this observed difference in functional outcome disappeared after adjustment for prognostic factors (adjusted common odds ratio, 0.91 [95% CI, 0.74-1.13]). Conclusions- Prior OAC use in patients treated with endovascular treatment for ischemic stroke is not associated with an increased risk of symptomatic intracranial hemorrhage or worse functional outcome compared with no prior OAC use. Therefore, prior OAC use should not be a contra-indication for endovascular treatment.",2020,Prior OAC use in patients treated with endovascular treatment for ischemic stroke is not associated with an increased risk of symptomatic intracranial hemorrhage or worse functional outcome compared with no prior OAC use.,"['patients on prior OAC', 'patients with and without prior use of OAC', 'Acute Ischemic Stroke in Patients on Oral Anticoagulants', 'patients with acute ischemic stroke caused by an intracranial anterior circulation occlusion, included in the nationwide, prospective, MR CLEAN Registry between March 2014 and November 2017, were analyzed', 'Three thousand one hundred sixty-two patients were included in this study, of whom 502 (16%) used OAC']","[' and Purpose', 'Endovascular Treatment', 'Conclusions', 'oral anticoagulants (OAC']","['occurrence of symptomatic intracranial hemorrhage', 'symptomatic intracranial hemorrhage and functional outcome at 90 days (modified Rankin Scale score', 'functional outcomes', 'risk of symptomatic intracranial hemorrhage']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0524466', 'cui_str': 'Intracranial'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C4517705', 'cui_str': '3100'}, {'cui': 'C4517835', 'cui_str': '62'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C1285529', 'cui_str': 'Purpose'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0151699', 'cui_str': 'Intracranial hemorrhage'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",3162.0,0.0786105,Prior OAC use in patients treated with endovascular treatment for ischemic stroke is not associated with an increased risk of symptomatic intracranial hemorrhage or worse functional outcome compared with no prior OAC use.,"[{'ForeName': 'Robert-Jan B', 'Initials': 'RB', 'LastName': 'Goldhoorn', 'Affiliation': 'From the Department of Neurology (R.-J.B.G., W.H.H., R.J. v.O.), Cardiovascular Research Institute Maastricht (CARIM), Maastricht University Medical Center.'}, {'ForeName': 'Rob A', 'Initials': 'RA', 'LastName': 'van de Graaf', 'Affiliation': 'Department of Neurology (R.A.v.d.G., J.M.v.R., D.W.J.D., B.R.), Erasmus MC, University Medical Center, Rotterdam.'}, {'ForeName': 'Jan M', 'Initials': 'JM', 'LastName': 'van Rees', 'Affiliation': 'Department of Neurology (R.A.v.d.G., J.M.v.R., D.W.J.D., B.R.), Erasmus MC, University Medical Center, Rotterdam.'}, {'ForeName': 'Hester F', 'Initials': 'HF', 'LastName': 'Lingsma', 'Affiliation': 'Department of Public Health (H.F.L.), Erasmus MC, University Medical Center, Rotterdam.'}, {'ForeName': 'Diederik W J', 'Initials': 'DWJ', 'LastName': 'Dippel', 'Affiliation': 'Department of Neurology (R.A.v.d.G., J.M.v.R., D.W.J.D., B.R.), Erasmus MC, University Medical Center, Rotterdam.'}, {'ForeName': 'Wouter H', 'Initials': 'WH', 'LastName': 'Hinsenveld', 'Affiliation': 'Department of Radiology (A.P., W.H.v.Z.), Cardiovascular Research Institute Maastricht (CARIM), Maastricht University Medical Center.'}, {'ForeName': 'Alida', 'Initials': 'A', 'LastName': 'Postma', 'Affiliation': 'Department of Radiology (A.P., W.H.v.Z.), Cardiovascular Research Institute Maastricht (CARIM), Maastricht University Medical Center.'}, {'ForeName': 'Ido', 'Initials': 'I', 'LastName': 'van den Wijngaard', 'Affiliation': 'Department of Neurology, Haaglanden Medical Center, The Hague (I.v.d.W.).'}, {'ForeName': 'Wim H', 'Initials': 'WH', 'LastName': 'van Zwam', 'Affiliation': 'From the Department of Neurology (R.-J.B.G., W.H.H., R.J. v.O.), Cardiovascular Research Institute Maastricht (CARIM), Maastricht University Medical Center.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'van Oostenbrugge', 'Affiliation': 'From the Department of Neurology (R.-J.B.G., W.H.H., R.J. v.O.), Cardiovascular Research Institute Maastricht (CARIM), Maastricht University Medical Center.'}, {'ForeName': 'Bob', 'Initials': 'B', 'LastName': 'Roozenbeek', 'Affiliation': 'Department of Neurology (R.A.v.d.G., J.M.v.R., D.W.J.D., B.R.), Erasmus MC, University Medical Center, Rotterdam.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Stroke,['10.1161/STROKEAHA.119.028675']
2775,32931320,"Retraction of:  Aceves-Martins M, Llauradó E, Tarro L, et al: A School-Based, Peer-Led, Social Marketing Intervention to Engage Spanish Adolescents in a Healthy Lifestyle (''We Are Cool''-Som la Pera Study): A Parallel Cluster Randomized Controlled Study [Child Obes 2017;13:300-313; doi: 10.1089/chi.2016.0216].",,2020,,"[""Engage Spanish Adolescents in a Healthy Lifestyle (''We Are Cool''-Som la Pera Study"", 'Child Obes 2017;13:300-313']",['Social Marketing Intervention'],[],"[{'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0037640', 'cui_str': 'Somalia'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4517707', 'cui_str': '313'}]","[{'cui': 'C0037424', 'cui_str': 'Social Marketing'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0292577,,[],Childhood obesity (Print),['10.1089/chi.2016.0216.retract']
2776,32932891,Comparison between Conventional Blind Injections and Ultrasound-Guided Injections of Botulinum Toxin Type A into the Masseter: A Clinical Trial.,"The aim of the study was to propose a more efficient and safer botulinum toxin type A (BoNT-A) injection method for the masseter by comparing the conventional blind injection and a novel ultrasonography (US)-guided injection technique in a clinical trial. The 40 masseters from 20 healthy young Korean volunteers (10 males and 10 females with a mean age of 25.6 years) were included in this prospective clinical trial. The BoNT-A (24 U) was injected into the masseter of each volunteer using the conventional blind and US-guided injection techniques on the left and right sides, respectively, and analyzed by US and three-dimensional (3D) facial scanning. One case of PMB (paradoxical masseteric bulging) was observed on the side where a conventional blind injection was performed, which disappeared after the compensational injection. The reduction in the thickness of the masseter in the resting state differed significantly at 1 month after the injection between the conventional blind injection group and the US-guided injection group by 12.38 ± 7.59% and 17.98 ± 9.65%, respectively ( t (19) = 3.059,  p  = 0.007). The reduction in the facial contour also differed significantly at 1 month after the injection between the conventional blind injection group and the US-guided injection group by 1.95 ± 0.74 mm and 2.22 ± 0.84 mm, respectively ( t (19) = 2.908,  p  = 0.009). The results of the study showed that the US-guided injection method that considers the deep inferior tendon by visualizing the masseter can prevent the PMB that can occur during a blind injection, and is also more effective.",2020,"The reduction in the facial contour also differed significantly at 1 month after the injection between the conventional blind injection group and the US-guided injection group by 1.95 ± 0.74 mm and 2.22 ± 0.84 mm, respectively ( t (19) =","['20 healthy young Korean volunteers (10 males and 10 females with a mean age of 25.6 years', 'Masseter']","['novel ultrasonography (US)-guided injection technique', 'botulinum toxin type A (BoNT-A) injection method', 'Botulinum Toxin Type']",['facial contour'],"[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0024876', 'cui_str': 'Masseter muscle structure'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C2960425', 'cui_str': 'Injection technique'}, {'cui': 'C0006050', 'cui_str': 'Botulinum Toxin Type A'}, {'cui': 'C0456651', 'cui_str': 'Method of injection'}]","[{'cui': 'C0015450', 'cui_str': 'Face structure'}]",20.0,0.0380531,"The reduction in the facial contour also differed significantly at 1 month after the injection between the conventional blind injection group and the US-guided injection group by 1.95 ± 0.74 mm and 2.22 ± 0.84 mm, respectively ( t (19) =","[{'ForeName': 'Hyungkyu', 'Initials': 'H', 'LastName': 'Bae', 'Affiliation': 'Division in Anatomy and Developmental Biology, Department of Oral Biology, Human Identification Research Institute, BK21 PLUS Project, Yonsei University College of Dentistry, 50-1 Yonsei-ro, Seodaemun-gu, Seoul 03722, Korea.'}, {'ForeName': 'Jisoo', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Youth Clinic, 30 Apgujeong-ro 80-gil, Gangnam-gu, Seoul 03722, Korea.'}, {'ForeName': 'Kyle K', 'Initials': 'KK', 'LastName': 'Seo', 'Affiliation': 'Modelo Clinic, 21 Apgujeong-ro 60-gil, Gangnam-gu, Seoul 03722, Korea.'}, {'ForeName': 'Kyung-Seok', 'Initials': 'KS', 'LastName': 'Hu', 'Affiliation': 'Division in Anatomy and Developmental Biology, Department of Oral Biology, Human Identification Research Institute, BK21 PLUS Project, Yonsei University College of Dentistry, 50-1 Yonsei-ro, Seodaemun-gu, Seoul 03722, Korea.'}, {'ForeName': 'Seong-Taek', 'Initials': 'ST', 'LastName': 'Kim', 'Affiliation': 'Department of Orofacial Pain and Oral Medicine, Yonsei University College of Dentistry, 50-1 Yonsei-ro, Seodaemun-gu, Seoul 03722, Korea.'}, {'ForeName': 'Hee-Jin', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Division in Anatomy and Developmental Biology, Department of Oral Biology, Human Identification Research Institute, BK21 PLUS Project, Yonsei University College of Dentistry, 50-1 Yonsei-ro, Seodaemun-gu, Seoul 03722, Korea.'}]",Toxins,['10.3390/toxins12090588']
2777,32932997,Virtual Reality-Based Cognitive-Motor Rehabilitation in Older Adults with Mild Cognitive Impairment: A Randomized Controlled Study on Motivation and Cognitive Function.,"The purpose of this study was to investigate the effects of virtual reality-based cognitive-motor rehabilitation (VRCMR) on the rehabilitation motivation and cognitive function in older adults. This study enrolled 40 older adults with mild cognitive impairment (MCI), living in the community. The subjects were randomly assigned to a VRCMR group ( n  = 20) or a conventional cognitive rehabilitation (CCR) group ( n  = 20). The VRCMR group underwent VRCMR using MOTOcog, a computer recognition program, whereas the CCR group underwent conventional cognitive rehabilitation, which included puzzles, wood blocks, card play, stick construction activity, and maze activity. Both interventions were performed 30 min per day, 5 days/week, for 6 weeks. This study performed a cognitive assessment using the Montreal Cognitive Assessment (MoCA) scale, Trail Making Test A and B (TMT-A/B), and Digit Span Test forward and backward (DST-forward/backward). In addition, a 0-to-10 numeric rating self-report scale was used to assess interest and motivation during the rehabilitation training. After the intervention, the VRCMR group showed a significantly greater improvement in the MoCA ( p  = 0.045), TMT-A ( p  = 0.039), TMT-B ( p  = 0.040), and DST-forward ( p  = 0.011) scores compared to the CCR group, but not in the DST-backward score ( p  = 0.424). In addition, subjects in the experimental group had significantly higher interest ( p  = 0.03) and motivation ( p  = 0.03) than those in the control group. Cohen's d effect size was 0.4, 0.3, 0.35, 0.4, and 0.5 for the MoCA, TMT-A, TMT-B, DST-forward, and DST-backward tests, respectively. This study demonstrates that VRCMR enhances motivation for rehabilitation and cognitive function in older adults with MCI better than CCR.",2020,"In addition, subjects in the experimental group had significantly higher interest ( p  = 0.03) and motivation ( p  = 0.03) than those in the control group.","['older adults', '40 older adults with mild cognitive impairment (MCI), living in the community', 'older adults with MCI better than CCR', 'Older Adults with Mild Cognitive Impairment']","['VRCMR', 'Virtual Reality-Based Cognitive-Motor Rehabilitation', 'conventional cognitive rehabilitation (CCR', 'virtual reality-based cognitive-motor rehabilitation (VRCMR']","['MoCA', 'Motivation and Cognitive Function', 'motivation', 'Montreal Cognitive Assessment (MoCA) scale, Trail Making Test A and B (TMT-A/B), and Digit Span Test forward and backward (DST-forward/backward']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1955905', 'cui_str': 'CCR Receptors'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0870303', 'cui_str': 'Cognitive rehabilitation'}, {'cui': 'C1955905', 'cui_str': 'CCR Receptors'}]","[{'cui': 'C0025750', 'cui_str': ""3,3'-Dichloro-4,4'-Diaminodiphenylmethane""}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0040604', 'cui_str': 'Trail making test'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439780', 'cui_str': 'Forward'}, {'cui': 'C0439781', 'cui_str': 'Backward'}, {'cui': 'C0262967', 'cui_str': 'Dihydrostreptomycin'}]",40.0,0.0188254,"In addition, subjects in the experimental group had significantly higher interest ( p  = 0.03) and motivation ( p  = 0.03) than those in the control group.","[{'ForeName': 'Ji-Su', 'Initials': 'JS', 'LastName': 'Park', 'Affiliation': 'Advanced Human Resource Development Project Group for Health Care in Aging Friendly, Industry, Dongseo University, Busan 47011, Korea.'}, {'ForeName': 'Young-Jin', 'Initials': 'YJ', 'LastName': 'Jung', 'Affiliation': 'Department of Radiological Science at Health Sciences Division in DongSeo University, Busan 47011, Korea.'}, {'ForeName': 'Gihyoun', 'Initials': 'G', 'LastName': 'Lee', 'Affiliation': 'Department of Physical and Rehabilitation Medicine, Center for Prevention and Rehabilitation, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul 135701, Korea.'}]","Healthcare (Basel, Switzerland)",['10.3390/healthcare8030335']
2778,32933153,Krill Oil Has Different Effects on the Plasma Lipidome Compared with Fish Oil Following 30 Days of Supplementation in Healthy Women: A Randomized Controlled and Crossover Study.,"This is a follow-up of our previous postprandial study and it focused on the plasma lipidomic responses to 30 days of krill oil (KO) versus fish oil (FO) supplementations in healthy women. Eleven women (aged 18-50 years) consumed KO or FO for 30 days in a randomized, cross-over study, with at least a four-week washout period between supplementations. The daily supplements provided 1.27 g/day of long-chain (LC) omega-3 polyunsaturated fatty acids (PUFA) from KO (containing 0.76 g eicosapentaenoic acid (EPA), 0.42 g docosahexaenoic acid (DHA)) and 1.44 g/day from FO (containing 0.79 g EPA, 0.47 g DHA). Fasting plasma samples at days 0, 15, and 30 were analyzed using gas chromatography and liquid chromatography electrospray ionisation-tandem mass spectrometry. KO resulted in a significantly greater relative area under the curve (relAUC) for plasma EPA after 30 days. Lipidomic analysis showed that 26 of 43 lipid molecular species had a significantly greater relAUC in the KO group, while 17/43 showed a significantly lower relAUC compared with the FO group. More than 38% of the lipids species which increased more following KO contained omega-3 PUFA, while where FO was greater than KO, only 12% contained omega-3 PUFA. These data show that KO and FO do not have equivalent effects on the plasma lipidome.",2020,KO resulted in a significantly greater relative area under the curve (relAUC) for plasma EPA after 30 days.,"['Eleven women (aged 18-50 years', 'healthy women', 'Healthy Women']","['long-chain (LC) omega-3 polyunsaturated fatty acids (PUFA) from KO (containing 0.76 g eicosapentaenoic acid (EPA), 0.42 g docosahexaenoic acid (DHA', 'Krill Oil', 'consumed KO or FO', 'krill oil (KO) versus fish oil (FO) supplementations', 'Fish Oil']","['relative area under the curve (relAUC) for plasma EPA', 'Fasting plasma samples', 'relAUC', 'Plasma Lipidome']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C2725341', 'cui_str': 'krill oil'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C4517458', 'cui_str': '0.42'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0142831', 'cui_str': 'sodium dehydroacetate'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0444263', 'cui_str': 'Plasma specimen'}, {'cui': 'C4727084', 'cui_str': 'Lipidome'}]",,0.0997975,KO resulted in a significantly greater relative area under the curve (relAUC) for plasma EPA after 30 days.,"[{'ForeName': 'Hyunsin H', 'Initials': 'HH', 'LastName': 'Sung', 'Affiliation': 'Institute for Health and Sport, Victoria University, P.O. Box 14428, Melbourne, VIC 8001, Australia.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Sinclair', 'Affiliation': 'Faculty of Health, Deakin University, Geelong, VIC 3217, Australia.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Huynh', 'Affiliation': 'Metabolomics Laboratory, Baker Heart and Diabetes Institute, Melbourne, VIC 3004, Australia.'}, {'ForeName': 'Adam A T', 'Initials': 'AAT', 'LastName': 'Smith', 'Affiliation': 'Metabolomics Laboratory, Baker Heart and Diabetes Institute, Melbourne, VIC 3004, Australia.'}, {'ForeName': 'Natalie A', 'Initials': 'NA', 'LastName': 'Mellett', 'Affiliation': 'Metabolomics Laboratory, Baker Heart and Diabetes Institute, Melbourne, VIC 3004, Australia.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Meikle', 'Affiliation': 'Metabolomics Laboratory, Baker Heart and Diabetes Institute, Melbourne, VIC 3004, Australia.'}, {'ForeName': 'Xiao Q', 'Initials': 'XQ', 'LastName': 'Su', 'Affiliation': 'Institute for Health and Sport, Victoria University, P.O. Box 14428, Melbourne, VIC 8001, Australia.'}]",Nutrients,['10.3390/nu12092804']
2779,32935564,Comparison of the Effects of Four Treatment Techniques Commonly Used in Ureteral Stone Treatment on Patients' Daily Physical Functioning: An Observational Randomized-Controlled Study.,"Objective:  To investigate the effect of four different techniques used in the treatment of ureteral stones on patients' daily physical functioning (PF) and quality of life (QoL).  Materials and Methods:  Patients who underwent ureterorenoscopy (URS)-with or without Double-J stenting (DJS)-and extracorporeal shock wave lithotripsy (SWL) were divided into four groups: Group I: SWL ( n  = 29), Group II: URS ( n  = 43), Group III: URS +4.8F DJS ( n  = 39), Group IV: URS +6F DJS ( n  = 42), and Group V: Control ( n  = 30). Short Form-36 (SF-36) was administered to each participant both preoperatively and 14 days after operation. Based on the SF-36 results, the changes in patients' PF and QoL were evaluated.  Results:  Ureteral stone treatment was performed in 202 patients. Of these, 153 patients who underwent an effective SWL or URS procedure in the first attempt were included in the study. Success rates in the first session were 53.7% (29/54) and 83.8% (124/148) for SWL and URS, respectively ( p  < 0.001). All the four groups were similar with regard to age, gender, body mass index, stone size, preoperative PF, and QoL. However, although postoperative PF, role limitations due to physical health, and energy/fatigue scores were similar in Group I, III, and IV, they were significantly higher in Group II. No major complication associated with SWL or URS occurred in any patient. However, in Group 2, DJS was inserted in three (7.7%) patients in the early postoperative period (within the first 48 hours) due to renal colic attacks secondary to ureterovesical junction mucosal edema.  Conclusion:  URS without DJS seems to be the most advantageous technique in the treatment of ureteral stones in terms of daily PF and QoL. However, it should be noted that patients undergoing URS may require postoperative emergency stenting, although rarely.",2020,"However, although postoperative physical functioning, role limitations due to physical health, and energy/fatigue scores were similar in Group I, III, and IV, they were significantly higher in Group II.","['153 patients who underwent a successful ESWL or URS procedure in the first attempt were included in the study', ""patients' daily physical functioning"", '202 patients', 'Patients who underwent']","['URS + 6 Fr DJS', 'ureteral stone treatment', 'URS', 'Ureterorenoscopy without DJS', 'URS + 4.8 Fr DJS', 'ESWL', 'ureterorenoscopy (URS)-with or without double j stenting (DJS)- and Extracorporeal shock wave lithotripsy (ESWL', 'ureteral stones']","['renal colic attacks secondary to ureterovesical junction mucosal edema', 'Success rates', 'ESWL or URS', ""patients' daily physical functioning and quality of life (QoL"", 'body mass index (BMI), stone size, preoperative physical functioning and QoL', 'postoperative physical functioning, role limitations due to physical health, and energy/fatigue scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0015359', 'cui_str': 'Extracorporeal shockwave lithotripsy'}, {'cui': 'C1270970', 'cui_str': 'Transurethral ureterorenoscopy'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C1270970', 'cui_str': 'Transurethral ureterorenoscopy'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0041952', 'cui_str': 'Ureteric stone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4517765', 'cui_str': '4.8'}, {'cui': 'C0015359', 'cui_str': 'Extracorporeal shockwave lithotripsy'}]","[{'cui': 'C0152169', 'cui_str': 'Renal colic'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}, {'cui': 'C0205144', 'cui_str': 'Junctional'}, {'cui': 'C0521481', 'cui_str': 'Mucous membrane edema'}, {'cui': 'C0015359', 'cui_str': 'Extracorporeal shockwave lithotripsy'}, {'cui': 'C1270970', 'cui_str': 'Transurethral ureterorenoscopy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0449454', 'cui_str': 'Stone size'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",202.0,0.0295533,"However, although postoperative physical functioning, role limitations due to physical health, and energy/fatigue scores were similar in Group I, III, and IV, they were significantly higher in Group II.","[{'ForeName': 'Gokhan', 'Initials': 'G', 'LastName': 'Sonmez', 'Affiliation': 'Department of Urology, Erciyes University, Kayseri, Turkey.'}, {'ForeName': 'Fatih', 'Initials': 'F', 'LastName': 'Demir', 'Affiliation': 'Department of Urology, Kayseri City Hospital, Kayseri, Turkey.'}, {'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Keske', 'Affiliation': 'Department of Urology, Kayseri City Hospital, Kayseri, Turkey.'}, {'ForeName': 'Mert Ali', 'Initials': 'MA', 'LastName': 'Karadag', 'Affiliation': 'Department of Urology, Kayseri City Hospital, Kayseri, Turkey.'}, {'ForeName': 'Abdullah', 'Initials': 'A', 'LastName': 'Demirtas', 'Affiliation': 'Department of Urology, Erciyes University, Kayseri, Turkey.'}]",Journal of endourology,['10.1089/end.2020.0659']
2780,32937905,"Motivation, Self-Concept and Discipline in Young Adolescents Who Practice Rhythmic Gymnastics. An Intervention.","This study aims to develop an intervention based on TARGET strategies in young people practicing rhythmic gymnastics, with the aim of observing whether motivation, discipline, self-concept and flexibility are improved. This research is a longitudinal study of a quasi-experimental nature. A total of 104 young adolescents between the ages of 11 and 12 years (11.66 ± 0.47) participated in the study, of which 60 belong to the control group and 44 to the experimental group. The intervention programme lasted two months (17 sessions). TARGET strategies were applied to the experimental group during training. While the experimental group continued with its routine training. To measure the psychological variables, the instrument used were the Youth Physical Self-Concept Scale (C-PSQ), Reason Scale for Discipline (RSD) and Success Perception Questionnaire (SPQ), and for flexibility, the tests were applied to the Sit and Reach and Deep trunk flexion test. The results showed that those teenagers who participated in the intervention, obtained an increased climate task, which entails an enjoyment by the practice of physical activity itself, more optimal levels of physical self-concept and discipline, subsequently, obtaining better results of flexibility. While in the control group gymnasts the ego climate and demotivation increased. TARGET strategies applied to young adolescents have positive effects, improve motivation towards physical activity, self-concept and discipline. This results in greater performance in flexibility. This will encourage young adolescents to continue to engage in physical activity in the future.",2020,"The results showed that those teenagers who participated in the intervention, obtained an increased climate task, which entails an enjoyment by the practice of physical activity itself, more optimal levels of physical self-concept and discipline, subsequently, obtaining better results of flexibility.","['Young Adolescents', '104 young adolescents between the ages of 11 and 12 years (11.66 ± 0.47) participated in the study, of which 60 belong to the control group and 44 to the experimental group', 'young people practicing rhythmic gymnastics', 'young adolescents']",[],"['Youth Physical Self-Concept Scale (C-PSQ), Reason Scale for Discipline (RSD) and Success Perception Questionnaire (SPQ), and for flexibility, the tests were applied to the Sit and Reach and Deep trunk flexion test']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0018409', 'cui_str': 'Gymnastics'}]",[],"[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0036594', 'cui_str': 'Self Concept'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C1627359', 'cui_str': 'Flexion test'}]",104.0,0.011366,"The results showed that those teenagers who participated in the intervention, obtained an increased climate task, which entails an enjoyment by the practice of physical activity itself, more optimal levels of physical self-concept and discipline, subsequently, obtaining better results of flexibility.","[{'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'González-Valero', 'Affiliation': 'Department of Didactics of Musical, Plastic and Corporal Expression, University of Granada (Spain), Campus de Cartuja, 18071 Granada, Spain.'}, {'ForeName': 'Félix', 'Initials': 'F', 'LastName': 'Zurita-Ortega', 'Affiliation': 'Department of Didactics of Musical, Plastic and Corporal Expression, University of Granada (Spain), Campus de Cartuja, 18071 Granada, Spain.'}, {'ForeName': 'José Luis', 'Initials': 'JL', 'LastName': 'Ubago-Jiménez', 'Affiliation': 'Department of Didactics of Musical, Plastic and Corporal Expression, University of Granada (Spain), Campus de Cartuja, 18071 Granada, Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Puertas-Molero', 'Affiliation': 'Department of Didactics of Musical, Plastic and Corporal Expression, University of Granada (Spain), Campus de Cartuja, 18071 Granada, Spain.'}]","Children (Basel, Switzerland)",['10.3390/children7090135']
2781,32942663,Assessment of Active Video Games' Energy Expenditure in Children with Overweight and Obesity and Differences by Gender.,"(1) Background: Childhood obesity has become a main global health problem and active video games (AVG) could be used to increase energy expenditure. The aim of this study was to investigate the energy expenditure during an AVG intervention combined with exercise, differentiating by gender. (2) Methods: A total of 45 children with overweight or obesity (19 girls) performed an AVG intervention combined with exercise. The AVG used were the Xbox Kinect, Nintendo Wii, dance mats, BKOOL cycling simulator, and Nintendo Switch. The energy expenditure was estimated from the heart rate recorded during the sessions and the data from the individual maximal tests. (3) Results: The mean energy expenditure was 315.1 kilocalories in a one-hour session. Participants spent the most energy on BKOOL, followed by Ring Fit Adventures, Dance Mats, Xbox Kinect, and the Nintendo Wii, with significant differences between BKOOL and the Nintendo Wii. Significant differences between boys and girls were found, but were partially due to the difference in weight, VO 2max , and fat-free mass. (4) Conclusions: The energy expenditure with AVG combined with multi-component exercise was 5.68 kcal/min in boys and 4.66 kcal/min in girls with overweight and obesity. AVG could be an effective strategy to increase energy expenditure in children and adolescents with overweight and obesity.",2020,"Participants spent the most energy on BKOOL, followed by Ring Fit Adventures, Dance Mats, Xbox Kinect, and the Nintendo Wii, with significant differences between BKOOL and the Nintendo Wii.","['Children with Overweight and Obesity and Differences by Gender', 'girls with overweight and obesity', 'children and adolescents with overweight and obesity', '45 children with overweight or obesity (19 girls']","['AVG combined with multi-component exercise', 'AVG intervention combined with exercise', 'AVG']","['mean energy expenditure', 'weight, VO 2max , and fat-free mass', 'energy expenditure', 'heart rate']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0042649', 'cui_str': 'Video Games'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",45.0,0.0423385,"Participants spent the most energy on BKOOL, followed by Ring Fit Adventures, Dance Mats, Xbox Kinect, and the Nintendo Wii, with significant differences between BKOOL and the Nintendo Wii.","[{'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Comeras-Chueca', 'Affiliation': 'Faculty of Health and Sport Science (FCSD), Department of Physiatry and Nursing, Universidad de Zaragoza, 50009 Zaragoza, Spain.'}, {'ForeName': 'Lorena', 'Initials': 'L', 'LastName': 'Villalba-Heredia', 'Affiliation': 'GENUD (Growth, Exercise, Nutrition and Development) Research Group, Department of Physiatry and Nursing, Universidad de Zaragoza, 50009 Zaragoza, Spain.'}, {'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'Pérez-Llera', 'Affiliation': 'GENUD (Growth, Exercise, Nutrition and Development) Research Group, Department of Physiatry and Nursing, Universidad de Zaragoza, 50009 Zaragoza, Spain.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Lozano-Berges', 'Affiliation': 'Faculty of Health and Sport Science (FCSD), Department of Physiatry and Nursing, Universidad de Zaragoza, 50009 Zaragoza, Spain.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Marín-Puyalto', 'Affiliation': 'GENUD (Growth, Exercise, Nutrition and Development) Research Group, Department of Physiatry and Nursing, Universidad de Zaragoza, 50009 Zaragoza, Spain.'}, {'ForeName': 'Germán', 'Initials': 'G', 'LastName': 'Vicente-Rodríguez', 'Affiliation': 'Faculty of Health and Sport Science (FCSD), Department of Physiatry and Nursing, Universidad de Zaragoza, 50009 Zaragoza, Spain.'}, {'ForeName': 'Ángel', 'Initials': 'Á', 'LastName': 'Matute-Llorente', 'Affiliation': 'Faculty of Health and Sport Science (FCSD), Department of Physiatry and Nursing, Universidad de Zaragoza, 50009 Zaragoza, Spain.'}, {'ForeName': 'José A', 'Initials': 'JA', 'LastName': 'Casajús', 'Affiliation': 'GENUD (Growth, Exercise, Nutrition and Development) Research Group, Department of Physiatry and Nursing, Universidad de Zaragoza, 50009 Zaragoza, Spain.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'González-Agüero', 'Affiliation': 'Faculty of Health and Sport Science (FCSD), Department of Physiatry and Nursing, Universidad de Zaragoza, 50009 Zaragoza, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17186714']
2782,32944790,Acute effects of alcohol on error-elicited negative affect during a cognitive control task.,"RATIONALE


Alcohol intoxication can dampen negative affective reactions to stressors. Recently, it has been proposed that these acute anxiolytic effects of alcohol may extend to dampening of negative affective reactions to error commission during cognitive control tasks. Nonetheless, empirical verification of this claim is lacking.
OBJECTIVES


Test the acute effect of alcohol on negative affective reactions to errors during an effort-demanding cognitive control task.
METHODS


Healthy, young adult social drinkers (N = 96 [49 women], 21-36 years old) were randomly assigned to consume alcohol (0.80 g/kg; n = 33 [15 female]), active placebo (0.04 g/kg; n = 33 [18 women]), or a non-alcoholic control beverage (n = 30 [16 women]) before completing the Eriksen flanker task. Corrugator supercilii (Corr) activation, a psychophysiological index of negative affect, was tracked across the task. Two neurophysiological reactions to errors, the error-related negativity (ERN) and the error positivity (Pe), were also measured.
RESULTS


Erroneous actions increased Corr activation in the control and (to a lesser extent) placebo groups, but not in the alcohol group. Error-induced Corr activation was coupled to ERN and Pe in the control, but not in the alcohol and placebo groups. Error-induced Corr activation was not coupled to post-error performance adjustments in any group.
CONCLUSIONS


The ability of alcohol to dampen error-related negative affect was verified. It was also shown that placebo alone can disrupt coupling of affective and (neuro)cognitive reactions to errors. Although its behavioral relevance remains to be demonstrated, more attention should be paid to the role of affect in action monitoring and cognitive control processes.",2020,"Error-induced Corr activation was coupled to ERN and Pe in the control, but not in the alcohol and placebo groups.","['Healthy, young adult social drinkers (N\u2009=\u200996 [49 women], 21-36\xa0years old']","['consume alcohol', 'alcohol', 'placebo', 'active placebo', 'non-alcoholic control beverage (n\u2009=\u200930 [16 women]) before completing the Eriksen flanker task']","['Corrugator supercilii (Corr) activation', 'error-related negativity (ERN) and the error positivity (Pe', 'Corr activation']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0337676', 'cui_str': 'Social drinker'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0687725', 'cui_str': 'Problem drinker'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0224127', 'cui_str': 'Structure of corrugator supercilii muscle'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}]",,0.0266923,"Error-induced Corr activation was coupled to ERN and Pe in the control, but not in the alcohol and placebo groups.","[{'ForeName': 'Roberto U', 'Initials': 'RU', 'LastName': 'Cofresí', 'Affiliation': 'Department of Psychological Sciences, University of Missouri, Columbia, MO, 65211, USA. cofresir@missouri.edu.'}, {'ForeName': 'Bruce D', 'Initials': 'BD', 'LastName': 'Bartholow', 'Affiliation': 'Department of Psychological Sciences, University of Missouri, Columbia, MO, 65211, USA.'}]",Psychopharmacology,['10.1007/s00213-020-05619-4']
2783,32950737,"A pragmatic stepped-wedge cluster randomized trial to evaluate the effectiveness and cost-effectiveness of active case finding for household contacts within a routine tuberculosis program, San Juan de Lurigancho, Lima, Peru.","BACKGROUND


Active case finding (ACF) in household contacts of tuberculosis (TB) patients is now recommended for National TB Programs (NTP) in low- and middle-income countries. However, evidence supporting these recommendations remains limited. This study evaluates the effectiveness and cost-effectiveness of ACF for household contacts of TB cases in a large TB endemic district of Lima, Peru.
METHODS


A pragmatic stepped-wedge cluster randomized controlled trial was conducted in 34 health centers of San Juan de Lurigancho district. Centers were stratified by TB rate and randomly allocated to initiate ACF in groups of eight or nine centers at four-month intervals. In the intervention arm, NTP providers visited households of index patients to screen contacts for active TB. The control arm was routine passive case finding (PCF) of symptomatic TB cases. The primary outcomes were the crude and adjusted active TB case rates among household contacts. Program costs were directly measured, and the cost-effectiveness of the ACF intervention was determined.
FINDINGS


3222 index TB cases and 12,566 household contacts were included in the study. ACF identified more household contact TB cases than PCF, 199.29/10,000 contacts/year vs. 132.13 (incidence rate ratio of 1.51 (95% CI 1.21-1.88)). ACF was associated with an incremental cost-effectiveness ratio of US $16,400 per disability-adjusted life year averted and not cost-effective assuming a willingness-to-pay threshold for Peru of US $6360.
CONCLUSION


ACF of TB case household contacts detected significantly more secondary TB cases than PCF alone, but was not cost-effective in this setting. In threshold analyses, ACF becomes cost-effective if associated with case detection rates 2.5 times higher than existing PCF programs.",2020,"ACF was associated with an incremental cost-effectiveness ratio of US $16,400 per disability-adjusted life year averted and not cost-effective assuming a willingness-to-pay threshold for Peru of US $6,360.
","['household contacts of tuberculosis (TB) patients', '34 health centers of San Juan de Lurigancho district', 'household contacts of TB cases in a large TB endemic district of Lima, Peru', '3,222 index TB cases and 12,566 household contacts were included in the study']","['PCF', 'ACF']","['effectiveness and cost-effectiveness', 'crude and adjusted active TB case rates among household contacts', 'Program costs']","[{'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0243130', 'cui_str': 'endemics'}, {'cui': 'C0031238', 'cui_str': 'Peru'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",,0.240111,"ACF was associated with an incremental cost-effectiveness ratio of US $16,400 per disability-adjusted life year averted and not cost-effective assuming a willingness-to-pay threshold for Peru of US $6,360.
","[{'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Shah', 'Affiliation': 'Department of Epidemiology, Biostatistics & Occupational Health, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Marlene', 'Initials': 'M', 'LastName': 'Rojas Peña', 'Affiliation': 'Red de Salud de San Juan de Lurigancho, Dirección de Salud Lima IV Este, Ministerio de Salud, Lima, Peru.'}, {'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Mori', 'Affiliation': 'Red de Salud de San Juan de Lurigancho, Dirección de Salud Lima IV Este, Ministerio de Salud, Lima, Peru.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Zamudio', 'Affiliation': 'Instituto de Medicina Tropical Alexander von Humboldt, Universidad Peruana Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Jay S', 'Initials': 'JS', 'LastName': 'Kaufman', 'Affiliation': 'Department of Epidemiology, Biostatistics & Occupational Health, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Larissa', 'Initials': 'L', 'LastName': 'Otero', 'Affiliation': 'Instituto de Medicina Tropical Alexander von Humboldt, Universidad Peruana Cayetano Heredia, Lima, Peru; Facultad de Medicina, Universidad Peruana Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Gotuzzo', 'Affiliation': 'Instituto de Medicina Tropical Alexander von Humboldt, Universidad Peruana Cayetano Heredia, Lima, Peru; Facultad de Medicina, Universidad Peruana Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Seas', 'Affiliation': 'Instituto de Medicina Tropical Alexander von Humboldt, Universidad Peruana Cayetano Heredia, Lima, Peru; Facultad de Medicina, Universidad Peruana Cayetano Heredia, Lima, Peru; Departamento de Enfermedades Infecciosas, Tropicales y Dermatológicas, Hospital Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Timothy F', 'Initials': 'TF', 'LastName': 'Brewer', 'Affiliation': 'Departments of Medicine and Epidemiology, David Geffen School of Medicine, Jonathan & Karin Fielding School of Public Health, University of California, Los Angeles, CA, United States. Electronic address: tbrewer@mednet.ucla.edu.'}]",International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases,['10.1016/j.ijid.2020.09.034']
2784,32950763,Stress-induced modulation of multiple memory systems during retrieval requires noradrenergic arousal.,"Stress has been shown to favor dorsal striatum-dependent 'habit' memory over hippocampus-dependent 'cognitive' memory during learning. Here, we investigated whether stress may modulate the engagement of these 'cognitive' and 'habit' systems also during memory retrieval and if so, whether such a stress-induced shift in the control of memory retrieval depends on noradrenergic activation. To this end, participants acquired a probabilistic classification learning (PCL) task that can be solved by both the 'cognitive' and the 'habit' system, reflected in the distinct behavioral strategies. Twenty-four hours later, participants received either the beta-adrenergic receptor antagonist propranolol or a placebo before they underwent a psychosocial stressor or a non-stressful control manipulation, followed by a retrieval version of the PCL task. Overall, participants showed a practice-dependent shift from 'cognitive' to 'habit' memory. Stressed participants that had received a placebo fell back to a 'cognitive' strategy during retrieval, which was linked to an impairment in retrieval performance. Propranolol blocked this stress-induced shift towards the less efficient strategy. Moreover, our results showed that salivary cortisol was related to the retrieval strategy only when paralleled by increased autonomic arousal. Together, these results indicate that stress effects on the modulation of multiple memory system during retrieval necessitate noradrenergic arousal, with relevant implications for retrieval performance under stress.",2020,"Overall, participants showed a practice-dependent shift from 'cognitive' to 'habit' memory.",[],"['Propranolol', 'placebo', 'beta-adrenergic receptor antagonist propranolol or a placebo']","['autonomic arousal', 'salivary cortisol']",[],"[{'cui': 'C0033497', 'cui_str': 'Propranolol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001645', 'cui_str': 'Beta adrenergic receptor antagonist'}]","[{'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}]",,0.0560178,"Overall, participants showed a practice-dependent shift from 'cognitive' to 'habit' memory.","[{'ForeName': 'Gundula', 'Initials': 'G', 'LastName': 'Zerbes', 'Affiliation': 'Department of Cognitive Psychology, University of Hamburg, Germany.'}, {'ForeName': 'Franziska Magdalena', 'Initials': 'FM', 'LastName': 'Kausche', 'Affiliation': 'Department of Cognitive Psychology, University of Hamburg, Germany.'}, {'ForeName': 'Jana Christina', 'Initials': 'JC', 'LastName': 'Müller', 'Affiliation': 'Department of Psychiatry, University Clinic Hamburg-Eppendorf, Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Wiedemann', 'Affiliation': 'Department of Psychiatry, University Clinic Hamburg-Eppendorf, Germany.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Schwabe', 'Affiliation': 'Department of Cognitive Psychology, University of Hamburg, Germany. Electronic address: lars.schwabe@uni-hamburg.de.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104867']
2785,32951537,Rivaroxaban for Prevention of Covert Brain Infarcts and Cognitive Decline: The COMPASS MRI Substudy.,"BACKGROUND AND PURPOSE


Covert brain infarcts are associated with cognitive decline. It is not known whether therapies that prevent symptomatic stroke prevent covert infarcts. COMPASS compared rivaroxaban with and without aspirin with aspirin for the prevention of stroke, myocardial infarction, and vascular death in participants with stable vascular disease and was terminated early because of benefits of rivaroxaban 2.5 mg twice daily plus aspirin over aspirin. We obtained serial magnetic resonance imagings and cognitive tests in a consenting subgroup of COMPASS patients to examine treatment effects on infarcts, cerebral microbleeds, and white matter hyperintensities.
METHODS


Baseline and follow-up magnetic resonance imagings were completed in 1445 participants with a mean (SD) interval of 2.0 (0.7) years. Whole-brain T1, T2 fluid-attenuated inversion recovery, T2* sequences were centrally interpreted by blinded, trained readers. Participants had serial measurements of cognition and function. The primary end point was the proportion of participants with incident covert infarcts. Secondary end points were the composite of clinical stroke and covert brain infarcts, cerebral microbleeds, and white matter hyperintensities.
RESULTS


At baseline, 493 (34.1%) participants had infarcts. Incident covert infarcts occurred in 55 (3.8%) participants. In the overall trial rivaroxaban plus aspirin reduced ischemic stroke by 49% (0.7% versus 1.4%; hazard ratio [95% CI], 0.51 [0.38-0.68]). In the magnetic resonance imaging substudy the effects of rivaroxaban+aspirin versus aspirin were: covert infarcts: 2.7% versus 3.5% (odds ratio [95% CI], 0.77 [0.37-1.60]); Covert infarcts or ischemic stroke: 2.9% versus 5.3% (odds ratio [95% CI], 0.53 [0.27-1.03]). Incident microbleeds occurred in 6.6% of participants and 65.7% of participants had an increase in white matter hyperintensities volume with no effect of treatment for either end point. There was no effect on cognitive tests.
CONCLUSIONS


Covert infarcts were not significantly reduced by treatment with rivaroxaban and aspirin but estimates for the combination of ischemic stroke and covert infarcts were consistent with the effect on ischemic stroke in the overall trial. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01776424.",2020,"In the overall trial rivaroxaban plus aspirin reduced ischemic stroke by 49% (0.7% versus 1.4%; hazard ratio [95% CI], 0.51 [0.38-0.68]).","['1445 participants with a mean (SD) interval of 2.0 (0.7) years', 'participants with stable vascular disease', 'consenting subgroup of COMPASS patients']","['rivaroxaban', 'aspirin with aspirin', 'aspirin over aspirin', 'rivaroxaban plus aspirin', 'Rivaroxaban', 'rivaroxaban+aspirin versus aspirin', 'aspirin']","['Incident covert infarcts', 'composite of clinical stroke and covert brain infarcts, cerebral microbleeds, and white matter hyperintensities', 'proportion of participants with incident covert infarcts', 'white matter hyperintensities volume', 'serial measurements of cognition and function', 'ischemic stroke', 'stroke, myocardial infarction, and vascular death', 'Covert infarcts or ischemic stroke', 'Incident microbleeds', 'cognitive tests']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C4517474', 'cui_str': '0.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0042373', 'cui_str': 'Vascular disorder'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0751955', 'cui_str': 'Brain Infarct'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",1445.0,0.524355,"In the overall trial rivaroxaban plus aspirin reduced ischemic stroke by 49% (0.7% versus 1.4%; hazard ratio [95% CI], 0.51 [0.38-0.68]).","[{'ForeName': 'Mukul', 'Initials': 'M', 'LastName': 'Sharma', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton Health Sciences, Hamilton, ON, Canada (M.S., R.G.H., J.B., J.W.E., S.J.C., L.D., K.W.R., A.C., E.M.L., S.Y.).'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Hart', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton Health Sciences, Hamilton, ON, Canada (M.S., R.G.H., J.B., J.W.E., S.J.C., L.D., K.W.R., A.C., E.M.L., S.Y.).'}, {'ForeName': 'Eric E', 'Initials': 'EE', 'LastName': 'Smith', 'Affiliation': 'Hotchkiss Brain Institute, University of Calgary, AB, Canada (E.E.S.).'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Bosch', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton Health Sciences, Hamilton, ON, Canada (M.S., R.G.H., J.B., J.W.E., S.J.C., L.D., K.W.R., A.C., E.M.L., S.Y.).'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Eikelboom', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton Health Sciences, Hamilton, ON, Canada (M.S., R.G.H., J.B., J.W.E., S.J.C., L.D., K.W.R., A.C., E.M.L., S.Y.).'}, {'ForeName': 'Stuart J', 'Initials': 'SJ', 'LastName': 'Connolly', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton Health Sciences, Hamilton, ON, Canada (M.S., R.G.H., J.B., J.W.E., S.J.C., L.D., K.W.R., A.C., E.M.L., S.Y.).'}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Dyal', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton Health Sciences, Hamilton, ON, Canada (M.S., R.G.H., J.B., J.W.E., S.J.C., L.D., K.W.R., A.C., E.M.L., S.Y.).'}, {'ForeName': 'Kevin W', 'Initials': 'KW', 'LastName': 'Reeh', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton Health Sciences, Hamilton, ON, Canada (M.S., R.G.H., J.B., J.W.E., S.J.C., L.D., K.W.R., A.C., E.M.L., S.Y.).'}, {'ForeName': 'Amparo', 'Initials': 'A', 'LastName': 'Casanova', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton Health Sciences, Hamilton, ON, Canada (M.S., R.G.H., J.B., J.W.E., S.J.C., L.D., K.W.R., A.C., E.M.L., S.Y.).'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Diaz', 'Affiliation': 'Estudios Clinicos Latino America and Instituto Cardiovascular de Rosario, Argentina (R.D.).'}, {'ForeName': 'Patricio', 'Initials': 'P', 'LastName': 'Lopez-Jaramillo', 'Affiliation': 'Research Institute, FOSCAL-Bucaramanga, Colombia (P.L.-J.).'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Ertl', 'Affiliation': 'Comprehensive Heart Failure Center, University and University Hospital, Würzburg, Germany (G.E., S.S.).'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Störk', 'Affiliation': 'Comprehensive Heart Failure Center, University and University Hospital, Würzburg, Germany (G.E., S.S.).'}, {'ForeName': 'Gilles R', 'Initials': 'GR', 'LastName': 'Dagenais', 'Affiliation': 'Institut Universitaire de Cardiologie et Pneumologie de Quebec, Quebec City, Canada (G.R.D.).'}, {'ForeName': 'Eva M', 'Initials': 'EM', 'LastName': 'Lonn', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton Health Sciences, Hamilton, ON, Canada (M.S., R.G.H., J.B., J.W.E., S.J.C., L.D., K.W.R., A.C., E.M.L., S.Y.).'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Ryden', 'Affiliation': 'Karolinska Institutet, Stockholm, Sweden (L.R.).'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Tonkin', 'Affiliation': 'Monash University, Melbourne, Australia (A.M.T., J.D.V.).'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Varigos', 'Affiliation': 'Monash University, Melbourne, Australia (A.M.T., J.D.V.).'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Brigham and Women's Hospital Heart and Vascular Center, Harvard, Medical School, Boston, MA (D.L.B.).""}, {'ForeName': 'Kelley R H', 'Initials': 'KRH', 'LastName': 'Branch', 'Affiliation': 'University of Washington Medical Centre, Seattle (K.R.H.B.).'}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Probstfield', 'Affiliation': 'University of Washington, Seattle (K.R.H.B., J.L.P.).'}, {'ForeName': 'Jae-Hyung', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'The Catholic University of Korea, Seoul, Korea (J.-H.K.).'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': ""O'Donnell"", 'Affiliation': 'National University of Ireland Galway, Galway, Ireland (M.O.).'}, {'ForeName': 'Dragos', 'Initials': 'D', 'LastName': 'Vinereanu', 'Affiliation': 'University of Medicine and Pharmacology Carol Davila University and Emergency Hospital, Bucharest, Romania (D.V.).'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'A A Fox', 'Affiliation': 'Centre for Cardiovascular Science, University of Edinburgh, Scotland, United Kingdom (K.A.A.F.).'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Liang', 'Affiliation': 'FuWai Hospital, Beijing, China (Y.L., L.L., J.Z.).'}, {'ForeName': 'Lisheng', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'FuWai Hospital, Beijing, China (Y.L., L.L., J.Z.).'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'FuWai Hospital, Beijing, China (Y.L., L.L., J.Z.).'}, {'ForeName': 'Nana', 'Initials': 'N', 'LastName': 'Pogosova', 'Affiliation': 'National Research Centre for Preventative Medicine, Moscow, Russia (N.P.).'}, {'ForeName': 'Aldo P', 'Initials': 'AP', 'LastName': 'Maggioni', 'Affiliation': 'ANMCO Research Center, Florence, Italy (A.P.M.).'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Avezum', 'Affiliation': 'Hospital Alemão Oswaldo Cruz, Sao Paulo, Brazil (A.A.).'}, {'ForeName': 'Leopoldo S', 'Initials': 'LS', 'LastName': 'Piegas', 'Affiliation': 'University of Sao Paulo, Sao Paulo, Brazil (L.S.P.).'}, {'ForeName': 'Katalin', 'Initials': 'K', 'LastName': 'Keltai', 'Affiliation': 'Semmelweis University, Budapest, Hungary (K.K., M.K.).'}, {'ForeName': 'Matyas', 'Initials': 'M', 'LastName': 'Keltai', 'Affiliation': 'Semmelweis University, Budapest, Hungary (K.K., M.K.).'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Berkowitz', 'Affiliation': 'Bayer AG, Leverkusen, Germany (S.D.B.).'}, {'ForeName': 'Salim', 'Initials': 'S', 'LastName': 'Yusuf', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton Health Sciences, Hamilton, ON, Canada (M.S., R.G.H., J.B., J.W.E., S.J.C., L.D., K.W.R., A.C., E.M.L., S.Y.).'}]",Stroke,['10.1161/STROKEAHA.120.029762']
2786,32927677,"Black Soybean Improves Vascular Function and Blood Pressure: A Randomized, Placebo Controlled, Crossover Trial in Humans.","Vascular dysfunction and injurious stimuli such as oxidative stress are closely related to the risk of cardiovascular diseases (CVD). Dietary polyphenols are reported to exert beneficial effects in reducing the risk of CVD. Black soybean has been used as a nutritionally rich food and contains abundant polyphenols in its seed coat and grain. Black soybean has many beneficial physiological activities, and its prevention effects on CVD risk were reported mainly in animal experiments. In this study, we performed a randomized, single blind, placebo controlled, crossover trial to investigate the effect of black soybean consumption on the vascular function in healthy humans. Twenty-two healthy adults aged from 30 to 60 completed the four week trial with daily consumption of about a 40 g test material cookie containing 20 g roasted black soybean powder. Body composition, vascular function, biomarkers for oxidative stress, and polyphenol contents in the urine and the plasma were measured. After ingestion of the black soybean cookie, vascular function, which was evaluated by plethysmogram using a Pulse Analyzer ® , was improved and systolic blood pressure was decreased. Moreover, nitric oxide levels in plasma and urine were increased, while an oxidative stress biomarker, 8-hydroxy-2'-deoxyguanosine level, in the plasma was decreased accompanied by an increase in the concentration of polyphenols derived from black soybean in plasma and urine. These results suggest that the antioxidant activity of black soybean polyphenols and an increase in the nitric oxide level may contribute to the improvement of vascular function. Thus, black soybean is an attractive food material for improvement of vascular function through decreasing oxidative stress by its potent antioxidant activity and increasing the nitric oxide level in healthy humans.",2020,"Moreover, nitric oxide levels in plasma and urine were increased, while an oxidative stress biomarker, 8-hydroxy-2'-deoxyguanosine level, in the plasma was decreased accompanied by an increase in the concentration of polyphenols derived from black soybean in plasma and urine.","['healthy humans', 'Humans', 'Twenty-two healthy adults aged from 30 to 60 completed the four week trial with']","['daily consumption of about a 40 g test material cookie containing 20 g roasted black soybean powder', 'black soybean consumption', 'placebo', 'Black Soybean', 'Placebo']","['nitric oxide level', 'Vascular Function and Blood Pressure', 'vascular function', 'nitric oxide levels in plasma and urine', 'systolic blood pressure', 'Body composition, vascular function, biomarkers for oxidative stress, and polyphenol contents', ""oxidative stress biomarker, 8-hydroxy-2'-deoxyguanosine level""]","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C3853210', 'cui_str': 'Cookie'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0450403', 'cui_str': '20G'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0037733', 'cui_str': 'Soya bean'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0050078', 'cui_str': '8-hydroxy-deoxyguanosine'}]",22.0,0.139485,"Moreover, nitric oxide levels in plasma and urine were increased, while an oxidative stress biomarker, 8-hydroxy-2'-deoxyguanosine level, in the plasma was decreased accompanied by an increase in the concentration of polyphenols derived from black soybean in plasma and urine.","[{'ForeName': 'Yoko', 'Initials': 'Y', 'LastName': 'Yamashita', 'Affiliation': 'Department of Agrobioscience, Graduate School of Agricultural Science, Kobe University, 1-1, Rokkodai-cho, Nada-ku, Kobe 657-8501, Japan.'}, {'ForeName': 'Asuka', 'Initials': 'A', 'LastName': 'Nakamura', 'Affiliation': 'Department of Agrobioscience, Graduate School of Agricultural Science, Kobe University, 1-1, Rokkodai-cho, Nada-ku, Kobe 657-8501, Japan.'}, {'ForeName': 'Fumio', 'Initials': 'F', 'LastName': 'Nanba', 'Affiliation': 'Fujicco Co. Ltd., Research Development, 6-13-4, Minatojima-Nakamachi, Chuo-Ku, Kobe 650-8558, Japan.'}, {'ForeName': 'Shizuka', 'Initials': 'S', 'LastName': 'Saito', 'Affiliation': 'Fujicco Co. Ltd., Research Development, 6-13-4, Minatojima-Nakamachi, Chuo-Ku, Kobe 650-8558, Japan.'}, {'ForeName': 'Toshiya', 'Initials': 'T', 'LastName': 'Toda', 'Affiliation': 'Fujicco Co. Ltd., Research Development, 6-13-4, Minatojima-Nakamachi, Chuo-Ku, Kobe 650-8558, Japan.'}, {'ForeName': 'Junichi', 'Initials': 'J', 'LastName': 'Nakagawa', 'Affiliation': 'Nakagawa Clinic, 3-15-4, Higashisonoda-cho, Amagasaki 661-0953, Japan.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Ashida', 'Affiliation': 'Department of Agrobioscience, Graduate School of Agricultural Science, Kobe University, 1-1, Rokkodai-cho, Nada-ku, Kobe 657-8501, Japan.'}]",Nutrients,['10.3390/nu12092755']
2787,32927741,Frailty Intervention through Nutrition Education and Exercise (FINE). A Health Promotion Intervention to Prevent Frailty and Improve Frailty Status among Pre-Frail Elderly-A Study Protocol of a Cluster Randomized Controlled Trial.,"The ageing process has been associated with various geriatric issues including frailty. Without early prevention, frailty may cause multiple adverse outcomes. However, it potentially may be reversed with appropriate interventions. The aim of the study is to assess the effectiveness of nutritional education and exercise intervention to prevent frailty among the elderly. A 3-month, single-blind, two-armed, cluster randomized controlled trial of the frailty intervention program among Malaysian pre-frail elderly will be conducted. A minimum of total 60 eligible respondents from 8 clusters (flats) of Program Perumahan Rakyat (PPR) flats will be recruited and randomized to the intervention and control arm. The intervention group will receive a nutritional education and a low to moderate multi-component exercise program. To date, this is the first intervention study that specifically targets both the degree of frailty and an improvement in the outcomes of frailty using both nutritional education and exercise interventions among Malaysian pre-frail elderly. If the study is shown to be effective, there are major potential benefits to older population in terms of preventing transition to frailty. The findings from this trial will potentially provide valuable evidence and serve as a model for similar future interventions designed for elderly Malaysians in the community.",2020,The aim of the study is to assess the effectiveness of nutritional education and exercise intervention to prevent frailty among the elderly.,"['total 60 eligible respondents from 8 clusters (flats) of Program Perumahan Rakyat (PPR) flats', 'Malaysian pre-frail elderly']","['nutritional education and a low to moderate multi-component exercise program', 'frailty intervention program', 'Health Promotion Intervention', 'nutritional education and exercise interventions', 'nutritional education and exercise intervention', 'Frailty Intervention through Nutrition Education and Exercise (FINE']",[],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205324', 'cui_str': 'Flat'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0079377', 'cui_str': 'Frail elderly'}]","[{'cui': 'C0204934', 'cui_str': 'Nutrition education'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018738', 'cui_str': 'Health promotion'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0205232', 'cui_str': 'Fine'}]",[],60.0,0.045271,The aim of the study is to assess the effectiveness of nutritional education and exercise intervention to prevent frailty among the elderly.,"[{'ForeName': 'Nurul Izzati', 'Initials': 'NI', 'LastName': 'Mohd Suffian', 'Affiliation': 'Department of Nutrition and Dietetics, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Selangor 43400, Malaysia.'}, {'ForeName': ""Siti Nur 'Asyura"", 'Initials': ""SN'"", 'LastName': 'Adznam', 'Affiliation': 'Department of Nutrition and Dietetics, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Selangor 43400, Malaysia.'}, {'ForeName': 'Hazizi', 'Initials': 'H', 'LastName': 'Abu Saad', 'Affiliation': 'Department of Nutrition and Dietetics, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Selangor 43400, Malaysia.'}, {'ForeName': 'Yoke Mun', 'Initials': 'YM', 'LastName': 'Chan', 'Affiliation': 'Department of Nutrition and Dietetics, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Selangor 43400, Malaysia.'}, {'ForeName': 'Zuriati', 'Initials': 'Z', 'LastName': 'Ibrahim', 'Affiliation': 'Department of Nutrition and Dietetics, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Selangor 43400, Malaysia.'}, {'ForeName': 'Noraida', 'Initials': 'N', 'LastName': 'Omar', 'Affiliation': 'Department of Nutrition and Dietetics, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Selangor 43400, Malaysia.'}, {'ForeName': 'Muhammad Faizal', 'Initials': 'MF', 'LastName': 'Murat', 'Affiliation': 'Department of Nutrition and Dietetics, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Selangor 43400, Malaysia.'}]",Nutrients,['10.3390/nu12092758']
2788,32927753,Potato Preload Mitigated Postprandial Glycemic Excursion in Healthy Subjects: An Acute Randomized Trial.,"This study investigated the preload effect of the medium and high glycemic index (GI) potato, as well as the combination of partially hydrolyzed guar gum (HG) and potato, when ingested prior to a rice meal, on the iso-carbohydrate basis. In a randomized crossover trial, 17 healthy female subjects consumed (1) rice; (2) co-ingestion of highly cooked potato (HP), and rice (HP + R); (3) co-ingestion of minimally cooked potato (MP) and rice (MP + R); (4) preload HP prior to rice meal (PHP + R); (5) preload MP prior to rice meal (PMP + R); (6) co-ingestion of partially hydrolyzed guar gum (HG), HP and rice (HG + HP + R); (7) preload HG prior to co-ingestion of HP and rice (PHG + HP + R); (8) co-preload of HG and HP prior to rice (PHG + PHP + R); and (9) preload of HP prior to co-ingestion of HG and rice (PHP + HG + R). Postprandial glycemic response (GR) tests and subjective satiety tests were conducted for each test food. Cooked potato as a preload to a rice meal could significantly cut the acute postprandial glycemic excursion by around 1.0 mmol/L, irrespective of the GI of the preload. Co-preload of partial hydrolyzed guar gum and highly cooked potato (PHG + PHP + R) resulted in improved acute GR in terms of peak glucose value and glycemic excursion compared with either HG preload or HP preload. All the meals with preload showed comparable or improved self-reported satiety. Within an equicarbohydrate exchange framework, both high-GI and medium-GI potato preload decreased the postprandial glycemic excursion in young healthy female subjects. The combination of HG and HP as double preload resulted in better GR than both single HG or HP preload did.",2020,(PHG + PHP + R) resulted in improved acute GR in terms of peak glucose value and glycemic excursion compared with either HG preload or HP preload.,"['young healthy female subjects', '17 healthy female subjects consumed (1) rice; (2', 'Healthy Subjects']","['co-ingestion of highly cooked potato (HP), and rice (HP + R); (3) co-ingestion of minimally cooked potato (MP) and rice (MP + R); (4) preload HP prior to rice meal (PHP + R); (5) preload MP prior to rice meal (PMP + R); (6) co-ingestion of partially hydrolyzed guar gum (HG), HP and rice (HG + HP + R', 'high-GI and medium-GI potato preload', 'Co-preload of partial hydrolyzed guar gum and highly cooked potato', 'preload HG prior to co-ingestion of HP and rice (PHG + HP + R); (8) co-preload of HG and HP prior to rice (PHG + PHP + R); and (9) preload of HP prior to co-ingestion of HG and rice (PHP + HG + R', 'PHG + PHP + R']","['Postprandial glycemic response (GR) tests and subjective satiety tests', 'self-reported satiety', 'Postprandial Glycemic Excursion', 'peak glucose value and glycemic excursion', 'postprandial glycemic excursion', 'acute postprandial glycemic excursion']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0035567', 'cui_str': 'Rice'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C0032846', 'cui_str': 'Potato'}, {'cui': 'C0035567', 'cui_str': 'Rice'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0061996', 'cui_str': 'guar gum'}, {'cui': 'C1136206', 'cui_str': 'Glycemic Index Number'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0728938', 'cui_str': 'Partial'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0036239', 'cui_str': 'Satiety'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]",17.0,0.012354,(PHG + PHP + R) resulted in improved acute GR in terms of peak glucose value and glycemic excursion compared with either HG preload or HP preload.,"[{'ForeName': 'Wenqi', 'Initials': 'W', 'LastName': 'Zhao', 'Affiliation': 'College of Food Science and Nutritional Engineering, China Agricultural University, Beijing 100083, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'College of Food Science and Nutritional Engineering, China Agricultural University, Beijing 100083, China.'}, {'ForeName': 'Yuqing', 'Initials': 'Y', 'LastName': 'Yuan', 'Affiliation': 'College of Food Science and Nutritional Engineering, China Agricultural University, Beijing 100083, China.'}, {'ForeName': 'Zhihong', 'Initials': 'Z', 'LastName': 'Fan', 'Affiliation': 'College of Food Science and Nutritional Engineering, China Agricultural University, Beijing 100083, China.'}, {'ForeName': 'Yixue', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'College of Food Science and Nutritional Engineering, China Agricultural University, Beijing 100083, China.'}, {'ForeName': 'Anshu', 'Initials': 'A', 'LastName': 'Liu', 'Affiliation': 'College of Food Science and Nutritional Engineering, China Agricultural University, Beijing 100083, China.'}, {'ForeName': 'Xuejiao', 'Initials': 'X', 'LastName': 'Lu', 'Affiliation': 'College of Food Science and Nutritional Engineering, China Agricultural University, Beijing 100083, China.'}]",Nutrients,['10.3390/nu12092759']
2789,32931919,The assertive cardiac care trial: A randomised controlled trial of a coproduced assertive cardiac care intervention to reduce absolute cardiovascular disease risk in people with severe mental illness in the primary care setting.,"BACKGROUND


Cardiovascular disease (CVD) accounts for 40% of the excess mortality identified in people with severe mental illness (SMI). Modifiable CVD risk factors are higher and can be exacerbated by the cardiometabolic impact of psychotropic medications. People with SMI frequently attend primary care presenting a valuable opportunity for early identification, prevention and management of cardiovascular health. The ACCT Healthy Hearts Study will test a coproduced, nurse-led intervention delivered with general practitioners to reduce absolute CVD risk (ACVDR) at 12 months compared with an active control group.
METHODS/DESIGN


ACCT is a two group (intervention/active control) individually randomised (1:1) controlled trial (RCT). Assessments will be completed baseline (pre-randomisation), 6 months, and 12 months. The primary outcome is 5-year ACVDR measured at 12 months. Secondary outcomes include 6-month ACVDR; and blood pressure, lipids, HbA1c, BMI, quality of life, physical activity, motivation to change health behaviour, medication adherence, alcohol use and hospitalisation at 6 and 12 months. Linear mixed-effects regression will estimate mean difference between groups for primary and secondary continuous outcomes. Economic cost-consequences analysis will be conducted using quality of life and health resource use information and routinely collected government health service use and medication data. A parallel process evaluation will investigate implementation of the intervention, uptake and outcomes.
DISCUSSION


ACCT will deliver a coproduced and person-centred, guideline level cardiovascular primary care intervention to a high need population with SMI. If successful, the intervention could lead to the reduction of the mortality gap and increase opportunities for meaningful social and economic participation. Trial registration ANZCTR Trial number: ACTRN12619001112156.",2020,"If successful, the intervention could lead to the reduction of the mortality gap and increase opportunities for meaningful social and economic participation.","['people with severe mental illness (SMI', 'people with severe mental illness in the primary care setting']",['coproduced assertive cardiac care intervention'],"['absolute CVD risk (ACVDR', '5-year ACVDR', '6-month ACVDR; and blood pressure, lipids, HbA1c, BMI, quality of life, physical activity, motivation to change health behaviour, medication adherence, alcohol use and hospitalisation at 6 and 12\u202fmonths']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0150158', 'cui_str': 'Cardiac care'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",,0.192142,"If successful, the intervention could lead to the reduction of the mortality gap and increase opportunities for meaningful social and economic participation.","[{'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Lewis', 'Affiliation': 'The Department of General Practice, Melbourne Medical School, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Australia.'}, {'ForeName': 'Patty', 'Initials': 'P', 'LastName': 'Chondros', 'Affiliation': 'The Department of General Practice, Melbourne Medical School, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Australia.'}, {'ForeName': 'Cathrine', 'Initials': 'C', 'LastName': 'Mihalopoulos', 'Affiliation': 'Deakin University, Geelong, Deakin Health Economics Unit, Faculty of Health, Australia.'}, {'ForeName': 'Yong Yi', 'Initials': 'YY', 'LastName': 'Lee', 'Affiliation': 'Deakin University, Geelong, Deakin Health Economics Unit, Faculty of Health, Australia; School of Public Health, The University of Queensland, Australia; Policy and Epidemiology Group, Queensland Centre for Mental Health Research, Australia.'}, {'ForeName': 'Jane M', 'Initials': 'JM', 'LastName': 'Gunn', 'Affiliation': 'The Department of General Practice, Melbourne Medical School, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Australia.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Harvey', 'Affiliation': 'The Department of Psychiatry, Melbourne Medical School, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Australia; NorthWestern Mental Health, Melbourne, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Furler', 'Affiliation': 'The Department of General Practice, Melbourne Medical School, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Osborn', 'Affiliation': 'Division of Psychiatry, Faculty of Brain Sciences, University College London, Australia; Camden and Islington NHS Foundation Trust, NW1OPE, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Castle', 'Affiliation': 'The Department of Psychiatry, Melbourne Medical School, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Australia.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Davidson', 'Affiliation': 'The Department of General Practice, Melbourne Medical School, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Australia.'}, {'ForeName': 'Mahesh', 'Initials': 'M', 'LastName': 'Jayaram', 'Affiliation': 'The Department of Psychiatry, Melbourne Medical School, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Australia; NorthWestern Mental Health, Melbourne, Australia.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Kenny', 'Affiliation': 'College of Science, Health and Engineering, La Trobe Rural Health School, Violet Vines Marshman Centre for Rural Health Research, La Trobe University, Australia.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Nelson', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Australia.'}, {'ForeName': 'Vera A', 'Initials': 'VA', 'LastName': 'Morgan', 'Affiliation': 'Neuropsychiatric Epidemiology Research Unit, School of Population and Global Health, University of Western Australia, Australia; Centre for Clinical Research in Neuropsychiatry, Division of Psychiatry, University of Western Australia, Australia.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Harrap', 'Affiliation': 'Department of Physiology, University of Melbourne, Australia.'}, {'ForeName': 'Kylie', 'Initials': 'K', 'LastName': 'McKenzie', 'Affiliation': 'The Department of General Practice, Melbourne Medical School, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Australia.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Potiriadis', 'Affiliation': 'The Department of General Practice, Melbourne Medical School, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Australia.'}, {'ForeName': 'Konstancja', 'Initials': 'K', 'LastName': 'Densley', 'Affiliation': 'The Department of General Practice, Melbourne Medical School, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Australia.'}, {'ForeName': 'Victoria J', 'Initials': 'VJ', 'LastName': 'Palmer', 'Affiliation': 'The Department of General Practice, Melbourne Medical School, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Australia. Electronic address: v.palmer@unimelb.edu.au.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106143']
2790,32932576,Evaluation of the Pharmacokinetic Drug-Drug Interaction between Micronized Fenofibrate and Pitavastatin in Healthy Volunteers.,"Dyslipidemia is a major risk factor for development of atherosclerosis and cardiovascular disease (CVD). Effective lipid-lowering therapies has led to CVD risk reduction. This study evaluated the possible pharmacokinetic interactions between fenofibrate, a peroxisome proliferators-activated receptors α agonist, and pitavastatin, a 3-hydoxy-3-methylglutaryl-coenzyme A reductase inhibitor, in healthy Korean subjects. The study design was an open-label, randomized, multiple-dose, three-period, and six-sequence crossover study with a 10-day washout in 24 healthy volunteers. It had three treatments: 160 mg of micronized fenofibrate once daily for 5 days; 2 mg of pitavastatin once daily for 5 days; and 160 mg of micronized fenofibrate with 2 mg of pitavastatin for 5 days. Serial blood samples were collected at scheduled intervals for up to 48 h after the last dose in each period to determine the steady-state pharmacokinetics of both drugs. Plasma concentrations of fenofibric acid and pitavastatin were measured using a validated high-performance liquid chromatography with the tandem mass spectrometry method. A total of 24 subjects completed the study. Pitavastatin, when co-administered with micronized fenofibrate, had no effect on the C max,ss  and AUC τ,ss  of fenofibric acid. The C max,ss  and AUC τ,ss  of pitavastatin were increased by 36% and 12%, respectively, when co-administered with fenofibrate. Combined treatment with pitavastatin and micronized fenofibrate was generally well tolerated without serious adverse events. Our results demonstrated no clinically significant pharmacokinetic interactions between micronized fenofibrate and pitavastatin when 160 mg of micronized fenofibrate and 2 mg of pitavastatin are co-administered. The treatments were well tolerated during the study, with no serious adverse events.",2020,"The C max,ss  and AUC τ,ss  of pitavastatin were increased by 36% and 12%, respectively, when co-administered with fenofibrate.","['24 healthy volunteers', 'healthy Korean subjects', 'Healthy Volunteers', '24 subjects completed the study']","['micronized fenofibrate', 'pitavastatin', 'pitavastatin and micronized fenofibrate', 'micronized fenofibrate and pitavastatin', 'Pitavastatin', 'fenofibrate', 'Micronized Fenofibrate and Pitavastatin']","['C max,ss  and AUC τ,ss  of fenofibric acid', 'tolerated without serious adverse events', 'C max,ss  and AUC τ,ss  of pitavastatin', 'Plasma concentrations of fenofibric acid and pitavastatin', 'pharmacokinetic interactions', 'Serial blood samples']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0033228', 'cui_str': 'Fenofibrate'}, {'cui': 'C1101838', 'cui_str': 'pitavastatin'}]","[{'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0060179', 'cui_str': 'Fenofibric acid'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1101838', 'cui_str': 'pitavastatin'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1868980', 'cui_str': 'Pharmacokinetic interaction'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}]",24.0,0.019179,"The C max,ss  and AUC τ,ss  of pitavastatin were increased by 36% and 12%, respectively, when co-administered with fenofibrate.","[{'ForeName': 'Hae Won', 'Initials': 'HW', 'LastName': 'Lee', 'Affiliation': 'Department of Molecular Medicine, School of Medicine, Kyungpook National University and Department of Clinical Pharmacology, Kyungpook National University Hospital, Daegu 41566, Korea.'}, {'ForeName': 'Woo Youl', 'Initials': 'WY', 'LastName': 'Kang', 'Affiliation': 'Department of Molecular Medicine, School of Medicine, Kyungpook National University and Department of Clinical Pharmacology, Kyungpook National University Hospital, Daegu 41566, Korea.'}, {'ForeName': 'Wookjae', 'Initials': 'W', 'LastName': 'Jung', 'Affiliation': 'Department of Molecular Medicine, School of Medicine, Kyungpook National University and Department of Clinical Pharmacology, Kyungpook National University Hospital, Daegu 41566, Korea.'}, {'ForeName': 'Mi-Ri', 'Initials': 'MR', 'LastName': 'Gwon', 'Affiliation': 'Department of Molecular Medicine, School of Medicine, Kyungpook National University and Department of Clinical Pharmacology, Kyungpook National University Hospital, Daegu 41566, Korea.'}, {'ForeName': 'Kyunghee', 'Initials': 'K', 'LastName': 'Cho', 'Affiliation': 'Analytical Research Division, Biocore Co. Ltd., Seoul 08511, Korea.'}, {'ForeName': 'Dong Heon', 'Initials': 'DH', 'LastName': 'Yang', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, School of Medicine, Kyungpook National University, Daegu 41944, Korea.'}, {'ForeName': 'Young-Ran', 'Initials': 'YR', 'LastName': 'Yoon', 'Affiliation': 'Department of Molecular Medicine, School of Medicine, Kyungpook National University and Department of Clinical Pharmacology, Kyungpook National University Hospital, Daegu 41566, Korea.'}, {'ForeName': 'Sook Jin', 'Initials': 'SJ', 'LastName': 'Seong', 'Affiliation': 'Department of Molecular Medicine, School of Medicine, Kyungpook National University and Department of Clinical Pharmacology, Kyungpook National University Hospital, Daegu 41566, Korea.'}]",Pharmaceutics,['10.3390/pharmaceutics12090869']
2791,32932584,Hyperhomocysteinemia Induced by Methionine Excess Is Effectively Suppressed by Betaine in Geese.,"The objective of our study was to investigate the effects of excess Methionine (Met) on the growth performance, serum homocysteine levels, apoptotic rates, and Bax and Bcl-2 protein levels in geese and to study the role of Bet (betaine) in relieving excess Met-induced hyperhomocysteinemia (HHcy). In this study, 150 healthy male 14-day-old Yangzhou geese of similar body weight were randomly distributed into three groups with five replicates per treatment and 10 geese per replicate: the control group (fed a control diet), the Met toxicity group (fed the control diet +1% Met), and the Bet detoxification group (fed the control diet +1% Met +0.2% Bet). At 28, 49, and 70 d of age, the geese in the Met toxicity group had significantly lower body weights than those in the control group ( p  < 0.05). The serum homocysteine levels in geese at 70 d of age in the detoxification group were significantly lower than those in the Met toxicity group ( p  < 0.05). Compared with the control, Met significantly increased cardiomyocyte apoptosis rates, while Bet reduced them. In conclusion, our results suggest that excess methionine reduces body weight induced by myocardial apoptosis, and Bet can be used to effectively lower plasma homocysteine levels.",2020,The serum homocysteine levels in geese at 70 d of age in the detoxification group were significantly lower than those in the Met toxicity group ( p  < 0.05).,['150 healthy male 14-day-old Yangzhou geese of similar body weight'],"['control group (fed a control diet), the Met toxicity group (fed the control diet +1% Met), and the Bet detoxification group (fed the control diet +1% Met +0.2% Bet', 'excess Methionine (Met']","['growth performance, serum homocysteine levels, apoptotic rates, and Bax and Bcl-2 protein levels', 'body weights', 'cardiomyocyte apoptosis rates', 'serum homocysteine levels', 'body weight', 'plasma homocysteine levels']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0017225', 'cui_str': 'Anser'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0743195', 'cui_str': 'Dietary control'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0016995', 'cui_str': 'Gambling'}, {'cui': 'C0025516', 'cui_str': 'Detoxication, Drug, Metabolic'}, {'cui': 'C4517436', 'cui_str': '0.2'}]","[{'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C1278080', 'cui_str': 'Serum homocysteine measurement'}, {'cui': 'C0219474', 'cui_str': 'Bax Protein'}, {'cui': 'C4042483', 'cui_str': 'BCL2 protein, human'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0225828', 'cui_str': 'Cardiac myocyte'}, {'cui': 'C0162638', 'cui_str': 'Apoptosis'}, {'cui': 'C1278165', 'cui_str': 'Plasma homocysteine measurement'}]",150.0,0.0147092,The serum homocysteine levels in geese at 70 d of age in the detoxification group were significantly lower than those in the Met toxicity group ( p  < 0.05).,"[{'ForeName': 'Zhi', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'Joint International Research Laboratory of Agriculture and Agri-Product Safety of the Ministry of Education of China, Yangzhou University, Yangzhou 225009, Jiangsu Province, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'College of Animal Science and Technology, Yangzhou University, Yangzhou 225009, Jiangsu Province, China.'}, {'ForeName': 'Jinjin', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'College of Animal Science and Technology, Yangzhou University, Yangzhou 225009, Jiangsu Province, China.'}, {'ForeName': 'Xiaoli', 'Initials': 'X', 'LastName': 'Wan', 'Affiliation': 'College of Animal Science and Technology, Yangzhou University, Yangzhou 225009, Jiangsu Province, China.'}, {'ForeName': 'Haiming', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'College of Animal Science and Technology, Yangzhou University, Yangzhou 225009, Jiangsu Province, China.'}, {'ForeName': 'Zhiyue', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Joint International Research Laboratory of Agriculture and Agri-Product Safety of the Ministry of Education of China, Yangzhou University, Yangzhou 225009, Jiangsu Province, China.'}]",Animals : an open access journal from MDPI,['10.3390/ani10091642']
2792,32932611,"Pre-Competition Weight Loss Models in Taekwondo: Identification, Characteristics and Risk of Dehydration.","Athletes use different combinations of weight loss methods during competition preparation. The aim of this study was to identify and characterize pre-competition weight loss models, which describe these combinations. The second aim was to determine if any existing model pose a higher risk of severe dehydration and whether any of the models could be continued as a lower-risk option. The third aim was to explore whether athletes who used different weight management strategies could be differentiated based on age, sex, training experience or anthropometric parameters. Study participants were randomly selected from Olympic taekwondo competitors and 192 athletes were enrolled. Active (47% weight-reducing athletes), passive (31%) and extreme (22%) models have been described. In the extreme model, athletes combined the highest number of different weight loss methods (3.9 ± 0.9 methods vs. 2.4 ± 0.9 in active and 1.5 ± 0.6 in passive), reduced significantly more body mass than others (6.7 ± 3.5% body mass vs. 4.3 ± 1.9% and 4.5 ± 2.4%;  p  < 0.01) and all of them used methods with the highest risk of severe dehydration. The active and passive models could be continued as a lower-risk option, if athletes do not combine dehydrating methods and do not prolong the low energy availability phase. The extreme model carried the highest risk of severe dehydration. Every fifth weight-reducing taekwondo athlete may have been exposed to the adverse effects of acute weight loss. Taekwondo athletes, regardless of age, sex, training experience and anthropometric parameters, lose weight before the competition and those characteristics do not differentiate them between models.",2020,The second aim was to determine if any existing model pose a higher risk of severe dehydration and whether any of the models could be continued as a lower-risk option.,['Study participants were randomly selected from Olympic taekwondo competitors and 192 athletes were enrolled'],[],['body mass'],"[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]",[],"[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}]",192.0,0.0386025,The second aim was to determine if any existing model pose a higher risk of severe dehydration and whether any of the models could be continued as a lower-risk option.,"[{'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Janiszewska', 'Affiliation': 'Department of Human Nutrition, Faculty of Food Science, University of Warmia and Mazury in Olsztyn, Słoneczna 45F Str., 10-718 Olsztyn, Poland.'}, {'ForeName': 'Katarzyna E', 'Initials': 'KE', 'LastName': 'Przybyłowicz', 'Affiliation': 'Department of Human Nutrition, Faculty of Food Science, University of Warmia and Mazury in Olsztyn, Słoneczna 45F Str., 10-718 Olsztyn, Poland.'}]",Nutrients,['10.3390/nu12092793']
2793,32932771,Effects of a Nine-Month Physical Activity Intervention on Morphological Characteristics and Motor and Cognitive Skills of Preschool Children.,"(1) Background: Regular physical activity (PA) plays an important role during early childhood physical and psychological development. This study investigates the effects of a 9-month PA intervention on physiological characteristics and motor and cognitive skills in preschool children. (2) Methods: Preschool children ( n  = 132; age 4 to 7 years) attending regular preschool programs were nonrandomly assigned to PA intervention ( n  = 66; 60 min sessions twice per week) or a control group ( n  = 66; no additional organized PA program) for 9 months. Exercise training for the intervention group included various sports games, outdoor activities, martial arts, yoga, and dance. Anthropometry, motor skills (7 tests), and cognitive skills (Raven's Colored Progressive Matrices and Cognitive Assessment System) were assessed before and after an intervention period in both groups. Data were analyzed using repeated-measures ANOVA. (3) Results: Body weight significantly increased in both groups over time. Compared to the changes observed in the control group, the intervention group significantly increased in chest circumference ( p  = 0.022). In contrast, the control group demonstrated an increase in waist circumference ( p  = 0.001), while these measures in the intervention group remained stable. Participants in the intervention group improved running speed ( p  = 0.016) and standing broad jump ( p  = 0.000). The flexibility level was maintained in the intervention group, while a significant decrease was observed in the control group ( p  = 0.010). Children from the intervention group demonstrated progress in the bent-arm hang test ( p  = 0.001), unlike the control group subjects. Varied improvements in cognitive skills were observed for different variables in both intervention and control groups, with no robust evidence for PA-intervention-related improvements. (4) Conclusions: Preschool children's participation in a preschool PA intervention improves their motor skills.",2020,"Varied improvements in cognitive skills were observed for different variables in both intervention and control groups, with no robust evidence for PA-intervention-related improvements.","['Preschool Children', ""Preschool children's"", 'preschool children', 'Preschool children ( n  = 132; age 4 to 7 years) attending regular preschool programs']","['Exercise training', 'Regular physical activity (PA', 'preschool PA intervention', 'Nine-Month Physical Activity Intervention', 'control group ( n  = 66; no additional organized PA program', 'PA intervention']","['chest circumference', 'flexibility level', 'motor skills', 'running speed', 'Morphological Characteristics and Motor and Cognitive Skills', 'waist circumference', 'physiological characteristics and motor and cognitive skills', 'cognitive skills', ""Anthropometry, motor skills (7 tests), and cognitive skills (Raven's Colored Progressive Matrices and Cognitive Assessment System"", 'Body weight']","[{'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1300196', 'cui_str': 'Organized'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0424683', 'cui_str': 'Chest circumference'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0026612', 'cui_str': 'Motor Skills'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0543482', 'cui_str': 'morphology'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1449597', 'cui_str': 'Corvus corax'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]",132.0,0.0149852,"Varied improvements in cognitive skills were observed for different variables in both intervention and control groups, with no robust evidence for PA-intervention-related improvements.","[{'ForeName': 'Damjan', 'Initials': 'D', 'LastName': 'Jaksic', 'Affiliation': 'Faculty of Sport and Physical Education, University of Novi Sad, 21000 Novi Sad, Serbia.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Mandic', 'Affiliation': 'Active Living Laboratory, School for Physical Education, Sport and Exercise Sciences, University of Otago, Dunedin 9016, New Zealand.'}, {'ForeName': 'Nebojsa', 'Initials': 'N', 'LastName': 'Maksimovic', 'Affiliation': 'Faculty of Sport and Physical Education, University of Novi Sad, 21000 Novi Sad, Serbia.'}, {'ForeName': 'Zoran', 'Initials': 'Z', 'LastName': 'Milosevic', 'Affiliation': 'Faculty of Sport and Physical Education, University of Novi Sad, 21000 Novi Sad, Serbia.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Roklicer', 'Affiliation': 'Faculty of Sport and Physical Education, University of Novi Sad, 21000 Novi Sad, Serbia.'}, {'ForeName': 'Jovan', 'Initials': 'J', 'LastName': 'Vukovic', 'Affiliation': 'Faculty of Sport and Physical Education, University of Novi Sad, 21000 Novi Sad, Serbia.'}, {'ForeName': 'Suncica', 'Initials': 'S', 'LastName': 'Pocek', 'Affiliation': 'Faculty of Sport and Physical Education, University of Novi Sad, 21000 Novi Sad, Serbia.'}, {'ForeName': 'Nemanja', 'Initials': 'N', 'LastName': 'Lakicevic', 'Affiliation': 'PhD Program in Health Promotion and Cognitive Sciences, University of Palermo, 90100 Palermo, Italy.'}, {'ForeName': 'Antonino', 'Initials': 'A', 'LastName': 'Bianco', 'Affiliation': 'Sport and Exercise Science Research Unit, University of Palermo, 90100 Palermo, Italy.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Cassar', 'Affiliation': 'Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Geelong 3216, Australia.'}, {'ForeName': 'Patrik', 'Initials': 'P', 'LastName': 'Drid', 'Affiliation': 'Faculty of Sport and Physical Education, University of Novi Sad, 21000 Novi Sad, Serbia.'}]",International journal of environmental research and public health,['10.3390/ijerph17186609']
2794,32935662,Providing Unique Support for Health Study Among Young Black and Latinx Men Who Have Sex With Men and Young Black and Latinx Transgender Women Living in 3 Urban Cities in the United States: Protocol for a Coach-Based Mobile-Enhanced Randomized Control Trial.,"BACKGROUND


The US National HIV/AIDS Strategy 2020 calls for increasing access to care, improving outcomes of people living with HIV, and targeting biomedical prevention efforts, including access to pre-exposure prophylaxis (PrEP) in communities where HIV is most heavily concentrated. The cities of Baltimore, Maryland (MD); Washington, DC; and Philadelphia, Pennsylvania (PA) are disproportionately burdened by high rates of new cases of HIV infection, with high prevalence among young Black and Latinx men who have sex with men (YBLMSM) and young Black and Latinx transgender women (YBLTW) aged 15-24 years.
OBJECTIVE


This study aims (1) to identify and recruit YBLMSM and YBLTW who are at risk or living with HIV in Baltimore, MD; Philadelphia, PA; and Washington, DC, using respondent-driven sampling (RDS) with targeted seed selection, and (2) to assess the efficacy of a coach-based mobile-enhanced intervention (MEI) compared with standard of care (SOC) to increase successful engagement and retention into HIV, PrEP, and substance use treatment care across the HIV care and prevention continua in 3 Mid-Atlantic cities. This paper describes the protocol and progress as of October 20, 2019.
METHODS


This study uses a multiphase mixed methods design. The first phase is a formative, qualitative research with focus group discussions and key informant interviews. The second phase consists of evaluating the ability of RDS with targeted seed selection. The third phase includes 2 embedded randomized controlled trials (RCTs), where participants complete a baseline sociobehavioral survey, rapid HIV testing, and eligible youth enroll in parallel status-dependent RCTs that randomize the participant to 1 of 2 study arms: MEI with coach or SOC. Participants are asked to complete a web-based survey and provide biologic specimens-HIV-1 RNA (viral load) or HIV-1 antibody test and urine drug screen-at baseline and at 3, 6, and 12 months, and an exit interview at 18 months.
RESULTS


A formative qualitative research was conducted in February 2017 and May 2018, and this led to further refinement of recruitment and study methods. Aim 1 recruitment began in September 2017 with subsequent enrollment into the RCTs. Recruitment is ongoing with 520 participants screened and 402 (77.3%) enrolled in aim 1 by October 2020. Of these, 159 are enrolled in the 2 randomized trials: 36 (22.6%) HIV-positive not virally suppressed (aim 2) and 123 (77.4%) high-risk HIV-negative (aim 3).
CONCLUSIONS


This study has the potential to significantly impact the medical and substance use services provided to YBLMSM and YBLTW in the United States by providing rigorous scientific evidence outlining approaches and strategies that improve the uptake and engagement of YBLMSM and YBLTW in the HIV treatment and prevention continuum.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03194477; https://clinicaltrials.gov/ct2/show/NCT03194477.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/17269.",2020,"This study has the potential to significantly impact the medical and substance use services provided to YBLMSM and YBLTW in the United States by providing rigorous scientific evidence outlining approaches and strategies that improve the uptake and engagement of YBLMSM and YBLTW in the HIV treatment and prevention continuum.
","['159 are enrolled in the 2 randomized trials: 36 (22.6%) HIV-positive not virally suppressed (aim 2) and 123 (77.4%) high-risk HIV-negative (aim 3', 'Young Black and Latinx Men', 'young Black and Latinx men who have sex with men (YBLMSM) and young Black and Latinx transgender women (YBLTW) aged 15-24 years', 'Living in 3 Urban Cities in the United States', 'Who Have Sex With Men and Young Black and Latinx Transgender Women', '520 participants screened and 402 (77.3%) enrolled in aim 1 by October 2020', 'September 2017 with subsequent enrollment into the RCTs']","['MEI with coach or SOC', 'coach-based mobile-enhanced intervention (MEI) compared with standard of care (SOC']",[],"[{'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0019699', 'cui_str': 'HIV positive'}, {'cui': 'C1260953', 'cui_str': 'Suppressed'}, {'cui': 'C2744535', 'cui_str': 'CD69 protein, human'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0481430', 'cui_str': 'HIV negative'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C1319927', 'cui_str': 'Male-to-female transsexual'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0558141', 'cui_str': 'Transsexual'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517803', 'cui_str': '520'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C3711547', 'cui_str': 'AURKB protein, human'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]",[],,0.144469,"This study has the potential to significantly impact the medical and substance use services provided to YBLMSM and YBLTW in the United States by providing rigorous scientific evidence outlining approaches and strategies that improve the uptake and engagement of YBLMSM and YBLTW in the HIV treatment and prevention continuum.
","[{'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Arrington-Sanders', 'Affiliation': 'Division of Adolescent and Young Adult Medicine, Johns Hopkins School of Medicine, Baltimore, MD, United States.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Hailey-Fair', 'Affiliation': 'Division of Adolescent and Young Adult Medicine, Johns Hopkins School of Medicine, Baltimore, MD, United States.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Wirtz', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States.'}, {'ForeName': 'Travis', 'Initials': 'T', 'LastName': 'Cos', 'Affiliation': 'Public Health Management Corporation Research & Evaluation Group, Philadelphia, PA, United States.'}, {'ForeName': 'Noya', 'Initials': 'N', 'LastName': 'Galai', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States.'}, {'ForeName': 'Durryle', 'Initials': 'D', 'LastName': 'Brooks', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States.'}, {'ForeName': 'Marne', 'Initials': 'M', 'LastName': 'Castillo', 'Affiliation': ""The Adolescent Initiative, Children's Hospital of Philadelphia, Philadelphia, MD, United States.""}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Dowshen', 'Affiliation': ""Craig Dalsimer Division of Adolescent Medicine, Children's Hospital of Philadelphia, Philadelphia, MD, United States.""}, {'ForeName': 'Constance', 'Initials': 'C', 'LastName': 'Trexler', 'Affiliation': ""Adolescent Clinical Research Burgess Clinic, Children's National Medical Center, Washington, DC, United States.""}, {'ForeName': 'Lawrence J', 'Initials': 'LJ', 'LastName': ""D'Angelo"", 'Affiliation': ""Adolescent Clinical Research Burgess Clinic, Children's National Medical Center, Washington, DC, United States.""}, {'ForeName': 'Jennafer', 'Initials': 'J', 'LastName': 'Kwait', 'Affiliation': 'Division of Adolescent and Young Adult Medicine, Johns Hopkins School of Medicine, Baltimore, MD, United States.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Beyrer', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Morgan', 'Affiliation': 'Division of Adolescent and Young Adult Medicine, Johns Hopkins School of Medicine, Baltimore, MD, United States.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Celentano', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': 'Division of Adolescent and Young Adult Medicine, Johns Hopkins School of Medicine, Baltimore, MD, United States.'}]",JMIR research protocols,['10.2196/17269']
2795,32937170,"Acute exercise increases circulating IGF-1 in Alzheimer's disease patients, but not in older adults without dementia.","OBJECTIVES


Increased Insulin-like growth factor I (IGF-1) has been associated with improvement of cognitive function in response to exercise. Evidences indicate a role for IGF-1 in beta-amyloid clearance and reducing hyperphosphorylation tau in Alzheimer's disease (AD). There is a need to investigate the IGF-1 response to exercise in AD patients due to well-known potential effects of exercise on IGF-1. The aim of this study was to examine circulating IGF-1 levels in AD patients and older adults without dementia after acute exercise and to verify the associations among cardiorespiratory fitness, cognition and IGF-1 levels.
METHOD


Seventy-four older adults (40 older adults without dementia and 34 AD patients) participated in this study. The outcomes included IGF-1 plasma levels and performance in the submaximal exercise stress test. Secondary outcomes included cognitive functions, depressive symptoms, level of physical activity, insulin-resistance, and cholesterol. All participants performed the incremental test on a treadmill and IGF-1 was collected before and after the exercise.
RESULTS


A tendency to the difference of baseline IGF-1 plasma levels between the groups was found. After the acute exercise AD patients also presented higher levels of circulating IGF-1 compared to the Older adults without dementia. Correlations among cardiorespiratory fitness and cognitive functions were found.
CONCLUSION


The findings suggest that AD patients and older adults respond differently to acute exercise in terms of circulating IGF-1 levels. This response seems to indicate either an IGF-1 resistance or a compensatory exercise-induced to lower IGF-1 levels in AD patients. Cardiorespiratory fitness is associated with global cognition, executive function, attention and information processing speed.",2021,A tendency to the difference of baseline IGF-1 plasma levels between the groups was found.,"[""Alzheimer's disease patients"", 'AD patients and older adults', ""Alzheimer's disease (AD"", 'Seventy-four older adults (40 older adults without dementia and 34 AD patients', 'AD patients and older adults without dementia after acute exercise']",['Acute exercise'],"['levels of circulating IGF-1', 'cardiorespiratory fitness and cognitive functions', 'IGF-1 levels', 'IGF-1 plasma levels and performance in the submaximal exercise stress test', 'baseline IGF-1 plasma levels', 'IGF-1 response', 'circulating IGF-1', 'cognitive functions, depressive symptoms, level of physical activity, insulin-resistance, and cholesterol', 'circulating IGF-1 levels']","[{'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C4517867', 'cui_str': '74'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C4279937', 'cui_str': 'Acute Exercise'}]","[{'cui': 'C4279937', 'cui_str': 'Acute Exercise'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}]",74.0,0.0477822,A tendency to the difference of baseline IGF-1 plasma levels between the groups was found.,"[{'ForeName': 'Angelica Miki', 'Initials': 'AM', 'LastName': 'Stein', 'Affiliation': 'Instituto de Biociências, Universidade Estadual Paulista (UNESP), Campus Rio Claro, Brazil; UTFPR, Federal University of Technology - Paraná (UTFPR), Campus Curitiba, Brazil. Electronic address: angelica_stein@yahoo.com.br.'}, {'ForeName': 'Thays Martins Vital', 'Initials': 'TMV', 'LastName': 'da Silva', 'Affiliation': 'Instituto de Biociências, Universidade Estadual Paulista (UNESP), Campus Rio Claro, Brazil; Instituto Federal Goiano, Campus Avançado Hidrolândia, Brazil.'}, {'ForeName': 'Flávia Gomes de Melo', 'Initials': 'FGM', 'LastName': 'Coelho', 'Affiliation': 'Instituto de Biociências, Universidade Estadual Paulista (UNESP), Campus Rio Claro, Brazil; Postgraduate Program in Physical Education, Federal University of Triangulo Mineiro, Uberaba, Brazil.'}, {'ForeName': 'André Veloso', 'Initials': 'AV', 'LastName': 'Rueda', 'Affiliation': 'Departamento de Farmacologia, Instituto de Ciências Biomédicas, Universidade de São Paulo, Campus São Paulo, Brazil.'}, {'ForeName': 'Rosana', 'Initials': 'R', 'LastName': 'Camarini', 'Affiliation': 'Departamento de Farmacologia, Instituto de Ciências Biomédicas, Universidade de São Paulo, Campus São Paulo, Brazil.'}, {'ForeName': 'Ruth Ferreira Santos', 'Initials': 'RFS', 'LastName': 'Galduróz', 'Affiliation': 'Instituto de Biociências, Universidade Estadual Paulista (UNESP), Campus Rio Claro, Brazil; Center of Mathematics, Computing and Cognition, University Federal of ABC (UFABC), Campus São Bernardo, Brazil.'}]",Behavioural brain research,['10.1016/j.bbr.2020.112903']
2796,32937232,A randomised oral fluoride retention study comparing intra-oral kinetics of fluoride-containing dentifrices before and after dietary acid exposure.,"OBJECTIVE


This exploratory, randomised, single-blind, crossover, study evaluated fluoride and calcium ion concentrations and pH following use of one of two 1450 ppm fluoride (NaF), 5% w/w KNO 3  dentifrices: (1) test dentifrice (with cocamidopropyl betaine) with an orange juice (OJ) rinse; (2) test dentifrice with a deionized (DI) water rinse or (3) comparator dentifrice (with sodium lauryl sulphate and tetrasodium pyrophosphate) with an OJ rinse.
DESIGN


Eighteen participants used their assigned dentifrice, rinsed with DI water, then expectorate was collected. Sixty min post-brushing, participants rinsed with OJ or DI water then expectorate was collected. Saliva samples were collected pre-brushing and at 1, 5, 10, 15, 30 and 60 min post-brushing and following the 60 min OJ/DI water rinse. The pH of samples was taken.
RESULTS


Significant differences (p < 0.05) were found in salivary fluoride ion concentrations between test and comparator dentifrices at 30 and 60 min and following the 60 min OJ rinse, favouring the former. Significant differences were also found between test and comparator dentifrices for salivary calcium ion concentration at 1, 5 and 10 min (p < 0.0001), favouring the former, and between test or comparator + OJ rinse and test + water rinse (p < 0.005), favouring the latter. No pH differences were shown prior to OJ/water rinse. Products were generally well-tolerated.
CONCLUSIONS


Results confirmed that acid-labile fluoride is released from the oral cavity following a dietary acid challenge and showed that formulation excipients may impact on retention of such.",2020,"Significant differences were also found between test and comparator dentifrices for salivary calcium ion concentration at 1, 5 and 10 min (p < 0.0001), favouring the former, and between test or comparator + OJ rinse and test + water rinse (p < 0.005), favouring the latter.",[],"['fluoride-containing dentifrices', '1450 ppm fluoride (NaF), 5% w/w KNO 3  dentifrices: (1) test dentifrice (with cocamidopropyl betaine) with an orange juice (OJ) rinse; (2) test dentifrice with a deionized (DI) water rinse or (3) comparator dentifrice (with sodium lauryl sulphate and tetrasodium pyrophosphate) with an OJ rinse']","['tolerated', 'salivary fluoride ion concentrations', 'salivary calcium ion concentration']",[],"[{'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0011427', 'cui_str': 'Dentifrice'}, {'cui': 'C0439187', 'cui_str': 'ppm'}, {'cui': 'C2919747', 'cui_str': 'w/w'}, {'cui': 'C1849409', 'cui_str': 'Retinal detachment and occipital encephalocele'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0173050', 'cui_str': 'cocamidopropyl betaine'}, {'cui': 'C0452458', 'cui_str': 'Orange juice'}, {'cui': 'C1701810', 'cui_str': 'Rinse'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0037506', 'cui_str': 'Sodium lauryl sulfate'}, {'cui': 'C0074764', 'cui_str': 'Pyrophosphate sodium'}]","[{'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0596235', 'cui_str': 'Calcium ion'}]",,0.0288269,"Significant differences were also found between test and comparator dentifrices for salivary calcium ion concentration at 1, 5 and 10 min (p < 0.0001), favouring the former, and between test or comparator + OJ rinse and test + water rinse (p < 0.005), favouring the latter.","[{'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Burnett', 'Affiliation': ""GSK Consumer Healthcare, St George's Avenue, Weybridge, Surrey, KT13 0DE, UK. Electronic address: Gary.R.Burnett@gsk.com.""}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Nehme', 'Affiliation': ""GSK Consumer Healthcare, St George's Avenue, Weybridge, Surrey, KT13 0DE, UK. Electronic address: drmnehme@gmail.com.""}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Parkinson', 'Affiliation': ""GSK Consumer Healthcare, St George's Avenue, Weybridge, Surrey, KT13 0DE, UK. Electronic address: charles.x.parkinson@gsk.com.""}, {'ForeName': 'Ritu', 'Initials': 'R', 'LastName': 'Karwal', 'Affiliation': 'GSK Consumer Healthcare, One Horizon Center, Golf Course Road, DLF Phase 5, Gurgaon, 12202, India. Electronic address: ritukarwal0283@gmail.com.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Badrock', 'Affiliation': 'Intertek Clinical Research Services, Oaklands Office Park, Hooton Rd, Hooton, Cheshire, CH66 7NZ UK. Electronic address: thomas.badrock@intertek.com.'}, {'ForeName': 'Gavin Vaughan', 'Initials': 'GV', 'LastName': 'Thomas', 'Affiliation': 'Intertek Clinical Research Services, Oaklands Office Park, Hooton Rd, Hooton, Cheshire, CH66 7NZ UK. Electronic address: gavin.thomas@intertek.com.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hall', 'Affiliation': 'Intertek Clinical Research Services, Oaklands Office Park, Hooton Rd, Hooton, Cheshire, CH66 7NZ UK. Electronic address: peter.hall@intertek.com.'}]",Archives of oral biology,['10.1016/j.archoralbio.2020.104891']
2797,32939927,"Comment on ""The effect of using a mobile application ('WhiteTeeth') on improving oral hygiene: A randomized controlled trial"" by Scheerman et al.",,2020,"Their analysis of a prospective randomized controlled study of 132 patients revealed the significant superiority of the study group (SG) with the mobile health (mHealth) program compared to the control group (CG) without the mHealth program on primary outcomes including the plaque index and gingival index, but not on secondary outcomes of oral health behaviors and psychosocial factors over the 12-week study period.","['2,3', 'adolescent patients', 'adolescent patients with orthodontic fixed appliances', '132 patients revealed the significant superiority of the study group (SG) with the mobile health (mHealth) program compared to the']","['control group (CG) without the mHealth program', 'mobile application (""WhiteTeeth']","['plaque index and gingival index', 'oral hygiene']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C0441421', 'cui_str': 'Fixed orthodontic appliance'}, {'cui': 'C0443289', 'cui_str': 'Revealed'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}]","[{'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}, {'cui': 'C0029164', 'cui_str': 'Dental Hygiene'}]",132.0,0.0255747,"Their analysis of a prospective randomized controlled study of 132 patients revealed the significant superiority of the study group (SG) with the mobile health (mHealth) program compared to the control group (CG) without the mHealth program on primary outcomes including the plaque index and gingival index, but not on secondary outcomes of oral health behaviors and psychosocial factors over the 12-week study period.","[{'ForeName': 'Yoshiko', 'Initials': 'Y', 'LastName': 'Myoken', 'Affiliation': 'Private Practice Myoken Dental Clinic, Hiroshima, Japan.'}, {'ForeName': 'Yoshinari', 'Initials': 'Y', 'LastName': 'Myoken', 'Affiliation': 'Department of Oral Surgery, Hiroshima Red Cross & Atomic-bomb Survivors Hospital, Hiroshima, Japan.'}, {'ForeName': 'Shigeaki', 'Initials': 'S', 'LastName': 'Toratani', 'Affiliation': 'Department of Molecular Oral Medicine and Maxillofacial Surgery, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.'}]",International journal of dental hygiene,['10.1111/idh.12464']
2798,32945777,Promoting Health and Well-Being Through Mobile Health Technology (Roadmap 2.0) in Family Caregivers and Patients Undergoing Hematopoietic Stem Cell Transplantation: Protocol for the Development of a Mobile Randomized Controlled Trial.,"BACKGROUND


Cancer patients who undergo allogeneic hematopoietic stem cell transplantation are among the most medically fragile patient populations with extreme demands for caregivers. Indeed, with earlier hospital discharges, the demands placed on caregivers continue to intensify. Moreover, an increased number of allogeneic hematopoietic stem cell transplantations are being performed worldwide, and this expensive procedure has significant economic consequences. Thus, the health and well-being of family caregivers have attracted widespread attention. Mobile health technology has been shown to deliver flexible, and time- and cost-sparing interventions to support family caregivers across the care trajectory.
OBJECTIVE


This protocol aims to leverage technology to deliver a novel caregiver-facing mobile health intervention named Roadmap 2.0. We will evaluate the effectiveness of Roadmap 2.0 in family caregivers of patients undergoing hematopoietic stem cell transplantation.
METHODS


The Roadmap 2.0 intervention will consist of a mobile randomized trial comparing a positive psychology intervention arm with a control arm in family caregiver-patient dyads. The primary outcome will be caregiver health-related quality of life, as assessed by the PROMIS Global Health scale at day 120 post-transplant. Secondary outcomes will include other PROMIS caregiver- and patient-reported outcomes, including companionship, self-efficacy for managing symptoms, self-efficacy for managing daily activities, positive affect and well-being, sleep disturbance, depression, and anxiety. Semistructured qualitative interviews will be conducted among participants at the completion of the study. We will also measure objective physiological markers (eg, sleep, activity, heart rate) through wearable wrist sensors and health care utilization data through electronic health records.
RESULTS


We plan to enroll 166 family caregiver-patient dyads for the full data analysis. The study has received Institutional Review Board approval as well as Code Review and Information Assurance approval from our health information technology services. Owing to the COVID-19 pandemic, the study has been briefly put on hold. However, recruitment began in August 2020. We have converted all recruitment, enrollment, and onboarding processes to be conducted remotely through video telehealth. Consent will be obtained electronically through the Roadmap 2.0 app.
CONCLUSIONS


This mobile randomized trial will determine if positive psychology-based activities delivered through mobile health technology can improve caregiver health-related quality of life over a 16-week study period. This study will provide additional data on the effects of wearable wrist sensors on caregiver and patient self-report outcomes.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04094844; https://www.clinicaltrials.gov/ct2/show/NCT04094844.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


PRR1-10.2196/19288.",2020,"Mobile health technology has been shown to deliver flexible, and time- and cost-sparing interventions to support family caregivers across the care trajectory.
","['Family Caregivers and Patients Undergoing Hematopoietic Stem Cell Transplantation', 'Cancer patients who undergo allogeneic hematopoietic stem cell transplantation', '166 family caregiver-patient dyads for the full data analysis', 'family caregivers of patients undergoing hematopoietic stem cell transplantation']",['positive psychology intervention arm with a control arm in family caregiver-patient dyads'],"['objective physiological markers (eg, sleep, activity, heart rate', 'caregiver health-related quality of life', 'caregiver health-related quality of life, as assessed by the PROMIS Global Health scale', 'PROMIS caregiver- and patient-reported outcomes, including companionship, self-efficacy for managing symptoms, self-efficacy for managing daily activities, positive affect and well-being, sleep disturbance, depression, and anxiety']","[{'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C5191361', 'cui_str': '166'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C1510628', 'cui_str': 'Positive Psychology'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.40449,"Mobile health technology has been shown to deliver flexible, and time- and cost-sparing interventions to support family caregivers across the care trajectory.
","[{'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Rozwadowski', 'Affiliation': 'Department of Pediatrics, Michigan Medicine, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Manasa', 'Initials': 'M', 'LastName': 'Dittakavi', 'Affiliation': 'Department of Pediatrics, Michigan Medicine, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Mazzoli', 'Affiliation': 'Department of Pediatrics, Michigan Medicine, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Afton L', 'Initials': 'AL', 'LastName': 'Hassett', 'Affiliation': 'Department of Anesthesia, Michigan Medicine, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Braun', 'Affiliation': 'Department of Biostatistics, School of Public Health, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Debra L', 'Initials': 'DL', 'LastName': 'Barton', 'Affiliation': 'School of Nursing, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Noelle', 'Initials': 'N', 'LastName': 'Carlozzi', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Michigan Medicine, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Srijan', 'Initials': 'S', 'LastName': 'Sen', 'Affiliation': 'Department of Psychiatry, Michigan Medicine, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Muneesh', 'Initials': 'M', 'LastName': 'Tewari', 'Affiliation': 'Department of Internal Medicine, Michigan Medicine, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Hanauer', 'Affiliation': 'Department of Pediatrics, Michigan Medicine, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Sung Won', 'Initials': 'SW', 'LastName': 'Choi', 'Affiliation': 'Department of Pediatrics, Michigan Medicine, University of Michigan, Ann Arbor, MI, United States.'}]",JMIR research protocols,['10.2196/19288']
2799,32941794,"Preoperative radiotherapy plus surgery versus surgery alone for patients with primary retroperitoneal sarcoma (EORTC-62092: STRASS): a multicentre, open-label, randomised, phase 3 trial.","BACKGROUND


Unlike for extremity sarcomas, the efficacy of radiotherapy for retroperitoneal sarcoma is not established. The aim of this study was to evaluate the impact of preoperative radiotherapy plus surgery versus surgery alone on abdominal recurrence-free survival.
METHODS


EORTC-62092 is an open-label, randomised, phase 3 study done in 31 research institutions, hospitals, and cancer centres in 13 countries in Europe and North America. Adults (aged ≥18 years) with histologically documented, localised, primary retroperitoneal sarcoma that was operable and suitable for radiotherapy, who had not been previously treated and had a WHO performance status and American Society of Anesthesiologists score of 2 or lower, were centrally randomly assigned (1:1), using an interactive web response system and a minimisation algorithm, to receive either surgery alone or preoperative radiotherapy followed by surgery. Randomisation was stratified by hospital and performance status. Radiotherapy was delivered as 50·4 Gy (in 28 daily fractions of 1·8 Gy) in either 3D conformal radiotherapy or intensity modulated radiotherapy, and the objective of surgery was a macroscopically complete resection of the tumour mass with en-bloc organ resection as necessary. The primary endpoint was abdominal recurrence-free survival, as assessed by the investigator, and was analysed in the intention-to-treat population. Safety was analysed in all patients who started their allocated treatment. This trial is registered with ClinicalTrials.gov, NCT01344018.
FINDINGS


Between Jan 18, 2012 and April 10, 2017, 266 patients were enrolled, of whom 133 were randomly assigned to each group. The median follow-up was 43·1 months (IQR 28·8-59·2). 128 (96%) patients from the surgery alone group had surgery, and 119 (89%) patients in the radiotherapy and surgery group had both radiotherapy and surgery. Median abdominal recurrence-free survival was 4·5 years (95% CI 3·9 to not estimable) in the radiotherapy plus surgery group and 5·0 years (3·4 to not estimable) in the surgery only group (hazard ratio 1·01, 95% CI 0·71-1·44; log rank p=0·95). The most common grade 3-4 adverse events were lymphopenia (98 [77%] of 127 patients in the radiotherapy plus surgery group vs one [1%] of 128 patients in the surgery alone group), anaemia (15 [12%] vs ten [8%]), and hypoalbuminaemia (15 [12%] vs five [4%]). Serious adverse events were reported in 30 (24%) of 127 patients in the radiotherapy plus surgery group, and in 13 (10%) of 128 patients in the surgery alone group. One (1%) of 127 patients in the radiotherapy plus surgery group died due to treatment-related serious adverse events (gastropleural fistula), and no patients in the surgery alone group died due to treatment-related serious adverse events.
INTERPRETATION


Preoperative radiotherapy should not be considered as standard of care treatment for retroperitoneal sarcoma.
FUNDING


European Organisation for Research and Treatment of Cancer, and European Clinical Trials in Rare Sarcomas.",2020,"Median abdominal recurrence-free survival was 4·5 years (95% CI 3·9 to not estimable) in the radiotherapy plus surgery group and 5·0 years (3·4 to not estimable) in the surgery only group (hazard ratio 1·01, 95% CI 0·71-1·44; log rank p=0·95).","['Between Jan 18, 2012 and April 10, 2017, 266 patients were enrolled, of whom 133 were randomly assigned to each group', 'Adults (aged ≥18 years) with histologically documented, localised, primary retroperitoneal sarcoma that was operable and suitable for radiotherapy, who had not been previously treated and had a WHO performance status and American Society of Anesthesiologists score of 2 or lower', 'patients with primary retroperitoneal sarcoma (EORTC-62092', '31 research institutions, hospitals, and cancer centres in 13 countries in Europe and North America']","['interactive web response system and a minimisation algorithm, to receive either surgery alone or preoperative radiotherapy followed by surgery', 'Preoperative radiotherapy plus surgery versus surgery alone', '3D conformal radiotherapy or intensity modulated radiotherapy', 'Radiotherapy', 'radiotherapy', 'preoperative radiotherapy plus surgery versus surgery alone']","['Safety', 'lymphopenia', 'Serious adverse events', 'anaemia', 'Median abdominal recurrence-free survival', 'abdominal recurrence-free survival']","[{'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0392752', 'cui_str': 'Localized'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0585129', 'cui_str': 'Retroperitoneal sarcoma'}, {'cui': 'C0205188', 'cui_str': 'Operable'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0028405', 'cui_str': 'North America'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0600521', 'cui_str': 'Conformal radiotherapy'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0024312', 'cui_str': 'Lymphocytopenia'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}]",266.0,0.228048,"Median abdominal recurrence-free survival was 4·5 years (95% CI 3·9 to not estimable) in the radiotherapy plus surgery group and 5·0 years (3·4 to not estimable) in the surgery only group (hazard ratio 1·01, 95% CI 0·71-1·44; log rank p=0·95).","[{'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Bonvalot', 'Affiliation': 'Department of Surgical Oncology, Institut Curie, Université Paris Sciences et Lettres, Paris, France. Electronic address: sylvie.bonvalot@curie.fr.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Gronchi', 'Affiliation': 'Department of Surgery, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Le Péchoux', 'Affiliation': 'Department of Radiation Oncology, Gustave Roussy Cancer Campus, Villejuif, France.'}, {'ForeName': 'Carol J', 'Initials': 'CJ', 'LastName': 'Swallow', 'Affiliation': 'Department of Surgical Oncology, Princess Margaret Cancer Centre, Toronto, ON, Canada.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Strauss', 'Affiliation': 'Department of Surgical Oncology, Royal Marsden Hospital, London, UK.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Meeus', 'Affiliation': 'Department of Surgical Oncology, Centre Léon Bérard, Lyon, France.'}, {'ForeName': 'Frits', 'Initials': 'F', 'LastName': 'van Coevorden', 'Affiliation': 'Department of Surgical Oncology, Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Stoldt', 'Affiliation': 'Department of Surgical Oncology, Oslo University Hospital, The Norwegian Radium Hospital, Oslo, Norway.'}, {'ForeName': 'Eberhard', 'Initials': 'E', 'LastName': 'Stoeckle', 'Affiliation': 'Department of Surgical Oncology, Institut Bergonié, Bordeaux, France.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Rutkowski', 'Affiliation': 'Department of Soft Tissue/Bone Sarcoma and Melanoma, Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Rastrelli', 'Affiliation': 'Department of Surgery, Veneto Institute of Oncology IOV-IRCCS, Padua, Italy.'}, {'ForeName': 'Chandrajit P', 'Initials': 'CP', 'LastName': 'Raut', 'Affiliation': ""Department of Surgery, Brigham and Women's Hospital, Boston, MA, USA; Center for Sarcoma and Bone Oncology, Dana-Farber Cancer Institute, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Daphne', 'Initials': 'D', 'LastName': 'Hompes', 'Affiliation': 'Department of Surgical Oncology, University Hospitals Gasthuisberg, Leuven, Belgium.'}, {'ForeName': 'Antonino', 'Initials': 'A', 'LastName': 'De Paoli', 'Affiliation': 'Centro di Riferimento Oncologico CRO-IRCCS, Aviano, Italy.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Sangalli', 'Affiliation': 'Department of Radiation Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Honoré', 'Affiliation': 'Department of Surgical Oncology, Gustave Roussy Cancer Campus, Villejuif, France.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Chung', 'Affiliation': 'Department of Radiation Oncology, Princess Margaret Cancer Centre, Toronto, ON, Canada.'}, {'ForeName': 'Aisha', 'Initials': 'A', 'LastName': 'Miah', 'Affiliation': 'Department of Radiation Oncology, Royal Marsden Hospital, London, UK.'}, {'ForeName': 'Jean Yves', 'Initials': 'JY', 'LastName': 'Blay', 'Affiliation': 'Department of Medical Oncology, Centre Léon Bérard, Lyon, France.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Fiore', 'Affiliation': 'Department of Surgery, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Jean-Jacques', 'Initials': 'JJ', 'LastName': 'Stelmes', 'Affiliation': 'Quality Assurance in Radiotherapy, European Organisation for Research and Treatment of Cancer, Brussels, Belgium.'}, {'ForeName': 'Angelo P', 'Initials': 'AP', 'LastName': 'Dei Tos', 'Affiliation': 'Department of Medicine, University of Padua School of Medicine, Padua, Italy.'}, {'ForeName': 'Elizabeth H', 'Initials': 'EH', 'LastName': 'Baldini', 'Affiliation': ""Department of Radiation Oncology, Brigham and Women's Hospital, Boston, MA, USA; Center for Sarcoma and Bone Oncology, Dana-Farber Cancer Institute, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Saskia', 'Initials': 'S', 'LastName': 'Litière', 'Affiliation': 'Department of Statistics, European Organisation for Research and Treatment of Cancer, Brussels, Belgium.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Marreaud', 'Affiliation': 'Headquarters, European Organisation for Research and Treatment of Cancer, Brussels, Belgium.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Gelderblom', 'Affiliation': 'Department of Medical Oncology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Rick L', 'Initials': 'RL', 'LastName': 'Haas', 'Affiliation': 'Department of Radiation Oncology, Netherlands Cancer Institute, Amsterdam, The Netherlands.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30446-0']
2800,32941801,Activate: Randomized Clinical Trial of BCG Vaccination against Infection in the Elderly.,"BCG vaccination in children protects against heterologous infections and improves survival independently of tuberculosis prevention. The phase III ACTIVATE trial assessed whether BCG has similar effects in the elderly. In this double-blind, randomized trial, elderly patients (n = 198) received BCG or placebo vaccine at hospital discharge and were followed for 12 months for new infections. At interim analysis, BCG vaccination significantly increased the time to first infection (median 16 weeks compared to 11 weeks after placebo). The incidence of new infections was 42.3% (95% CIs 31.9%-53.4%) after placebo vaccination and 25.0% (95% CIs 16.4%-36.1%) after BCG vaccination; most of the protection was against respiratory tract infections of probable viral origin (hazard ratio 0.21, p = 0.013). No difference in the frequency of adverse effects was found. Data show that BCG vaccination is safe and can protect the elderly against infections. Larger studies are needed to assess protection against respiratory infections, including COVID-19 (ClinicalTrials.gov NCT03296423).",2020,"At interim analysis, BCG vaccination significantly increased the time to first infection (median 16 weeks compared to 11 weeks after placebo).","['elderly patients (n\xa0= 198) received', 'Elderly']","['BCG', 'BCG vaccination', 'Activate', 'BCG or placebo vaccine']","['frequency of adverse effects', 'incidence of new infections', 'time to first infection']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0004886', 'cui_str': 'BCG vaccine'}, {'cui': 'C0199804', 'cui_str': 'BCG vaccination'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439633', 'cui_str': 'New infection'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]",,0.444856,"At interim analysis, BCG vaccination significantly increased the time to first infection (median 16 weeks compared to 11 weeks after placebo).","[{'ForeName': 'Evangelos J', 'Initials': 'EJ', 'LastName': 'Giamarellos-Bourboulis', 'Affiliation': '4(th) Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, 124 62 Athens, Greece. Electronic address: egiamarel@med.uoa.gr.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Tsilika', 'Affiliation': '4(th) Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, 124 62 Athens, Greece.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Moorlag', 'Affiliation': 'Department of Internal Medicine and Radboud Center for Infectious Diseases, Radboud University Medical Center, 6500 Nijmegen, the Netherlands.'}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Antonakos', 'Affiliation': '4(th) Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, 124 62 Athens, Greece.'}, {'ForeName': 'Antigone', 'Initials': 'A', 'LastName': 'Kotsaki', 'Affiliation': '4(th) Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, 124 62 Athens, Greece.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Domínguez-Andrés', 'Affiliation': 'Department of Internal Medicine and Radboud Center for Infectious Diseases, Radboud University Medical Center, 6500 Nijmegen, the Netherlands.'}, {'ForeName': 'Evdoxia', 'Initials': 'E', 'LastName': 'Kyriazopoulou', 'Affiliation': '4(th) Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, 124 62 Athens, Greece.'}, {'ForeName': 'Theologia', 'Initials': 'T', 'LastName': 'Gkavogianni', 'Affiliation': '4(th) Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, 124 62 Athens, Greece.'}, {'ForeName': 'Maria-Evangelia', 'Initials': 'ME', 'LastName': 'Adami', 'Affiliation': '4(th) Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, 124 62 Athens, Greece.'}, {'ForeName': 'Georgia', 'Initials': 'G', 'LastName': 'Damoraki', 'Affiliation': '4(th) Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, 124 62 Athens, Greece.'}, {'ForeName': 'Panagiotis', 'Initials': 'P', 'LastName': 'Koufargyris', 'Affiliation': '4(th) Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, 124 62 Athens, Greece.'}, {'ForeName': 'Athanassios', 'Initials': 'A', 'LastName': 'Karageorgos', 'Affiliation': '4(th) Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, 124 62 Athens, Greece.'}, {'ForeName': 'Amalia', 'Initials': 'A', 'LastName': 'Bolanou', 'Affiliation': '4(th) Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, 124 62 Athens, Greece.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Koenen', 'Affiliation': 'Department of Laboratory Medicine, Radboud University Medical Center, 6500 Nijmegen, the Netherlands.'}, {'ForeName': 'Reinout', 'Initials': 'R', 'LastName': 'van Crevel', 'Affiliation': 'Department of Internal Medicine and Radboud Center for Infectious Diseases, Radboud University Medical Center, 6500 Nijmegen, the Netherlands.'}, {'ForeName': 'Dionyssia-Irene', 'Initials': 'DI', 'LastName': 'Droggiti', 'Affiliation': '4(th) Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, 124 62 Athens, Greece.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Renieris', 'Affiliation': '4(th) Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, 124 62 Athens, Greece.'}, {'ForeName': 'Antonios', 'Initials': 'A', 'LastName': 'Papadopoulos', 'Affiliation': '4(th) Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, 124 62 Athens, Greece.'}, {'ForeName': 'Mihai G', 'Initials': 'MG', 'LastName': 'Netea', 'Affiliation': 'Department of Internal Medicine and Radboud Center for Infectious Diseases, Radboud University Medical Center, 6500 Nijmegen, the Netherlands; Department of Immunology and Metabolism, Life & Medical Sciences Institute, University of Bonn, 53115 Bonn, Germany.'}]",Cell,['10.1016/j.cell.2020.08.051']
2801,32957204,Evaluation of the implant stability and the marginal bone level changes during the first three months of dental implant healing process: A prospective clinical study.,"Achievement of adequate implant stability is one of the determinants for long-term successful osseointegration. Resonance frequency analysis was developed to monitor implant stability and is now a well-recognized, non-invasive tool for determining the appropriate time for functional loading. However, there have been few studies with continuous evaluation and comparison of implant stability and marginal bone level changes between two different macro designs and clinical situations during the implant healing process. Thus, the purpose of this clinical trial is to evaluate the implant stability and marginal bone level changes of straight and conical implants during the implant healing process. In this prospective clinical trial, 25 participants were randomized to either straight or conical implants. A total of 32 titanium dental implants with a length of 9 mm or 11 mm were installed in the maxilla and the mandible according to the manufacturer's instructions. A resonance frequency analyzer was used to measure the implant stability quotient (ISQ) at the time of implant placement and after 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, and 12 weeks of healing. The changes in the peri-implant marginal bone level were evaluated from digital radiographic films taken at the time of implant placement and after 4 weeks, 8 weeks, and 12 weeks of healing. The preliminary results of this study revealed higher ISQ values and better healing tendency for conical implants in comparison with straight implants in the maxilla. Similar ISQ values and healing tendency were observed for straight and conical implants in the mandible. No significant differences in marginal bone loss were found between the straight and conical implants. However, in the mandible, slightly more marginal bone loss was found with the conical implants than straight implants after 12 weeks of healing. In conclusion, ISQ healing tendency and marginal bone loss are influenced by implant macro-design and jaw regions. Straight implants revealed similar ISQ healing tendency and marginal bone loss in both the mandible and maxilla. Conical implants were confirmed more beneficial for maintenance of implant stability and marginal bone level in the maxilla.",2020,"However, in the mandible, slightly more marginal bone loss was found with the conical implants than straight implants after 12 weeks of healing.","[""32 titanium dental implants with a length of 9\xa0mm or 11\xa0mm were installed in the maxilla and the mandible according to the manufacturer's instructions"", '25 participants']",['straight or conical implants'],"['implant stability and marginal bone level', 'ISQ values', 'healing tendency', 'Similar ISQ values and healing tendency', 'marginal bone loss', 'implant stability quotient (ISQ', 'ISQ healing tendency and marginal bone loss', 'peri-implant marginal bone level']","[{'cui': 'C0040302', 'cui_str': 'Titanium'}, {'cui': 'C0011370', 'cui_str': 'Dental implantation'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}]","[{'cui': 'C0019421', 'cui_str': 'Heterosexuality'}, {'cui': 'C0021102', 'cui_str': 'Implant'}]","[{'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0347985', 'cui_str': 'During values'}]",25.0,0.0429769,"However, in the mandible, slightly more marginal bone loss was found with the conical implants than straight implants after 12 weeks of healing.","[{'ForeName': 'Yi-Han', 'Initials': 'YH', 'LastName': 'Su', 'Affiliation': 'School of Dentistry, College of Oral Medicine, Taipei Medical University, Taipei, Taiwan; Division of Prosthodontics, Department of Dentistry, Taipei Medical University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Bou-Yue', 'Initials': 'BY', 'LastName': 'Peng', 'Affiliation': 'School of Dentistry, College of Oral Medicine, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Peter-D', 'Initials': 'PD', 'LastName': 'Wang', 'Affiliation': 'School of Dentistry, College of Oral Medicine, Taipei Medical University, Taipei, Taiwan; Department of Periodontics, College of Dental Medicine, Columbia University, New York, USA.'}, {'ForeName': 'Sheng-Wei', 'Initials': 'SW', 'LastName': 'Feng', 'Affiliation': 'School of Dentistry, College of Oral Medicine, Taipei Medical University, Taipei, Taiwan; Division of Prosthodontics, Department of Dentistry, Taipei Medical University Hospital, Taipei, Taiwan. Electronic address: shengwei@tmu.edu.tw.'}]",Journal of the mechanical behavior of biomedical materials,['10.1016/j.jmbbm.2020.103899']
2802,32957209,Accelerated loading frequency does not influence the fatigue behavior of polymer infiltrated ceramic network or lithium disilicate glass-ceramic restorations.,"This study aimed to evaluate the influence of loading frequency on the fatigue mechanical behavior of adhesively cemented polymer-infiltrated ceramic-network (PICN) and lithium disilicate (LD) simplified monolithic restorations. Thirty (30) disc-shaped specimens (Ø = 10 mm; thickness = 1.0 mm) of each ceramic material (PICN - Enamic, Vita Zahnfabrik or LD - IPS e.max CAD, Ivoclar Vivadent) were produced and adhesively cemented onto dentin analogue discs made of fiber and epoxy resin material (Ø = 10 mm; thickness = 2.0 mm). PICN and LD cemented assemblies were randomly allocated into 2 groups (n = 15) according to the loading frequency used for the fatigue testing (20 Hz or 2 Hz), composing the PICN_20, PICN_2, LD_20 and LD_2 testing groups. Fatigue tests were run using the step-stress approach (initial load = 200 N; step-size = 100 N; 10,000 cycles per step) and the collected data (fatigue failure load - FFL and number of cycles for failure - CFF) were analyzed by survival tests (Kaplan Meier and Mantel-Cox) and Weibull analysis. Fractographic analysis of failed specimens were also performed. No statistically significant differences were detected in relation to FFL and CFF between the groups within the same ceramic material (PICN_20: 1127 N/102,667 cycles = PICN_2: 1120 N/102,000 cycles; LD_20: 980 N/88,000 cycles = LD_2: 900 N/80,000 cycles). All failures were radial cracks in the cementation surface. Therefore, the use of a 20 Hz loading frequency shows to be a viable alternative to accelerate cyclic fatigue tests without affecting the fatigue mechanical behavior and the failure pattern of simplified restorations made of lithium disilicate glass ceramic or polymer infiltrated ceramic network bonded to the dentin analogue.",2020,"No statistically significant differences were detected in relation to FFL and CFF between the groups within the same ceramic material (PICN_20: 1127 N/102,667 cycles = PICN_2: 1120 N/102,000 cycles; LD_20: 980 N/88,000 cycles = LD_2: 900 N/80,000 cycles).","['PICN and LD cemented assemblies', 'Thirty (30) disc-shaped specimens (Ø =\xa010\xa0mm; thickness =\xa01.0\xa0mm) of each ceramic material (PICN - Enamic, Vita Zahnfabrik or LD - IPS e.max CAD, Ivoclar Vivadent) were produced and adhesively cemented onto dentin analogue discs made of fiber and epoxy resin material (Ø =\xa010\xa0mm; thickness =\xa02.0\xa0mm']",['adhesively cemented polymer-infiltrated ceramic-network (PICN) and lithium disilicate (LD) simplified monolithic restorations'],"['Fatigue tests', 'relation to FFL and CFF']","[{'cui': 'C0032521', 'cui_str': 'Polymer'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0007742', 'cui_str': 'Ceramic'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C1528812', 'cui_str': 'lithia disilicate'}, {'cui': 'C0011343', 'cui_str': 'Cementum structure'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C4308553', 'cui_str': 'ENAMIC'}, {'cui': 'C0373745', 'cui_str': 'Vitamin A measurement'}, {'cui': 'C0011905', 'cui_str': 'Computer-Assisted Diagnosis'}, {'cui': 'C0124269', 'cui_str': 'Ivoclar'}, {'cui': 'C0148539', 'cui_str': 'Vivadent'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0014631', 'cui_str': 'Epoxy resin'}]","[{'cui': 'C0011343', 'cui_str': 'Cementum structure'}, {'cui': 'C0032521', 'cui_str': 'Polymer'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0007742', 'cui_str': 'Ceramic'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C1528812', 'cui_str': 'lithia disilicate'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0080103', 'cui_str': 'Relative'}]",,0.0333511,"No statistically significant differences were detected in relation to FFL and CFF between the groups within the same ceramic material (PICN_20: 1127 N/102,667 cycles = PICN_2: 1120 N/102,000 cycles; LD_20: 980 N/88,000 cycles = LD_2: 900 N/80,000 cycles).","[{'ForeName': 'Helder Callegaro', 'Initials': 'HC', 'LastName': 'Velho', 'Affiliation': 'MSciD and PhD Post-Graduate Program in Oral Science, Faculty of Dentistry, Federal University of Santa Maria (UFSM), Santa Maria, Rio Grande do Sul State, Brazil. Electronic address: heldercvelho@hotmail.com.'}, {'ForeName': 'Kiara Serafini', 'Initials': 'KS', 'LastName': 'Dapieve', 'Affiliation': 'MSciD and PhD Post-Graduate Program in Oral Science, Faculty of Dentistry, Federal University of Santa Maria (UFSM), Santa Maria, Rio Grande do Sul State, Brazil. Electronic address: kiara_s_d@hotmail.com.'}, {'ForeName': 'Gabriel Kalil', 'Initials': 'GK', 'LastName': 'Rocha Pereira', 'Affiliation': 'MSciD and PhD Post-Graduate Program in Oral Science, Faculty of Dentistry, Federal University of Santa Maria (UFSM), Santa Maria, Rio Grande do Sul State, Brazil. Electronic address: gabrielkrpereira@hotmail.com.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Fraga', 'Affiliation': 'Department of Conservative Dentistry, Federal University of Rio Grande do Sul (UFRGS), Porto Alegre, Rio Grande do Sul State, Brazil. Electronic address: sara.odonto@yahoo.com.br.'}, {'ForeName': 'Luiz Felipe', 'Initials': 'LF', 'LastName': 'Valandro', 'Affiliation': 'MSciD and PhD Post-Graduate Program in Oral Science, Faculty of Dentistry, Federal University of Santa Maria (UFSM), Santa Maria, Rio Grande do Sul State, Brazil. Electronic address: valandrolf@gmail.com.'}, {'ForeName': 'Andressa Borin', 'Initials': 'AB', 'LastName': 'Venturini', 'Affiliation': 'MSciD and PhD Post-Graduate Program in Oral Science, Faculty of Dentistry, Federal University of Santa Maria (UFSM), Santa Maria, Rio Grande do Sul State, Brazil. Electronic address: andressa.venturini@hotmail.com.'}]",Journal of the mechanical behavior of biomedical materials,['10.1016/j.jmbbm.2020.103905']
2803,32957242,Influence of Deep Margin Elevation and preparation design on the fracture strength of indirectly restored molars.,"The objectives of this in-vitro study were to investigate the influence of Deep Margin Elevation (DME) and the preparation design (cusp coverage) on the fracture strength and repairability of CAD/CAM manufactured lithium disilicate (LS 2 ) restorations on molars. Sound extracted human molars (n = 60) were randomly divided into 4 groups (n = 15) (inlay without DME (InoD); inlay with DME (IWD); onlay without DME (OnoD); onlay with DME (OnWD)). All samples were aged (1.2 × 10 6  cycles of 50N, 8000 cycles of 5-55 °C) followed by oblique static loading until fracture. Fracture strength was measured in Newton and the fracture analysis was performed using a (scanning electron) microscope. Data was statistically analyzed using two-way ANOVA and contingency tables. DME did not affect the fracture strength of LS 2  restorations to a statistically significant level (p = .15). Onlays were stronger compared to inlays (p = .00). DME and preparation design did not interact (p = .97). However, onlays with DME were significantly stronger than inlays without DME (p = .00). More repairable fractures were observed among inlays (p = .00). Catastrophic, crown-root fractures were more prevalent in onlays (p = .00). DME did not influence repairability of fractures or fracture types to a statistically significant level (p > .05). Within the limitations of this in-vitro study, DME did not statistical significantly affect the fracture strength, nor the fracture type or repairability of LS 2  restorations in molars. Cusp coverage did increase the fracture strength. However, oblique forces necessary to fracture both inlays and onlays, either with or without DME, by far exceeded the bite forces that can be expected under physiological clinical conditions. Hence, both inlays and onlays are likely to be fracture resistant during clinical service.",2020,DME did not influence repairability of fractures or fracture types to a statistically significant level (p > .05).,"['All samples were aged (1.2\xa0×\xa010 6  cycles of 50N, 8000 cycles of 5-55\xa0°C) followed by oblique static loading until fracture', 'CAD/CAM manufactured lithium disilicate (LS 2 ) restorations on molars', 'Sound extracted human molars (n\xa0=\xa060']","['15) (inlay without DME (InoD); inlay with DME (IWD); onlay without DME (OnoD); onlay with DME (OnWD', 'DME']","['repairable fractures', 'fracture strength of indirectly restored molars', 'Deep Margin Elevation (DME', 'Catastrophic, crown-root fractures', 'Fracture strength', 'fracture strength']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4068880', 'cui_str': '1.2'}, {'cui': 'C3840857', 'cui_str': '8000'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0205315', 'cui_str': 'Oblique'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0011905', 'cui_str': 'Computer-Assisted Diagnosis'}, {'cui': 'C0002346', 'cui_str': 'Medicine, Alternative'}, {'cui': 'C1528812', 'cui_str': 'lithia disilicate'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0037709', 'cui_str': 'Sonic Radiation'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0021513', 'cui_str': 'Dental Inlays'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0058217', 'cui_str': 'dimethyl ether'}]","[{'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C4704755', 'cui_str': 'Fracture Strength'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0010384', 'cui_str': 'Crown'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}]",60.0,0.0204494,DME did not influence repairability of fractures or fracture types to a statistically significant level (p > .05).,"[{'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Bresser', 'Affiliation': 'University Medical Center Groningen, University of Groningen, Center for Dentistry and Oral Hygiene, Department of Restorative Dentistry and Biomaterials, Groningen, the Netherlands.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'van de Geer', 'Affiliation': 'University Medical Center Groningen, University of Groningen, Center for Dentistry and Oral Hygiene, Department of Restorative Dentistry and Biomaterials, Groningen, the Netherlands.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Gerdolle', 'Affiliation': 'Private Practice, Montreux, Switzerland.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Schepke', 'Affiliation': 'University Medical Center Groningen, University of Groningen, Center for Dentistry and Oral Hygiene, Department of Restorative Dentistry and Biomaterials, Groningen, the Netherlands.'}, {'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'Cune', 'Affiliation': 'University Medical Center Groningen, University of Groningen, Center for Dentistry and Oral Hygiene, Department of Restorative Dentistry and Biomaterials, Groningen, the Netherlands; St. Antonius Hospital, Department of Oral Maxillofacial Surgery, Prosthodontics and Special Dental Care, Nieuwegein, the Netherlands; University of Utrecht, University Medical Center Utrecht, Department of Oral Maxillofacial Surgery, Prosthodontics and Special Dental Care, Utrecht, the Netherlands.'}, {'ForeName': 'M M M', 'Initials': 'MMM', 'LastName': 'Gresnigt', 'Affiliation': 'University Medical Center Groningen, University of Groningen, Center for Dentistry and Oral Hygiene, Department of Restorative Dentistry and Biomaterials, Groningen, the Netherlands; Martini Hospital, Department of Special Dental Care, Groningen, the Netherlands. Electronic address: marcogresnigt@yahoo.com.'}]",Journal of the mechanical behavior of biomedical materials,['10.1016/j.jmbbm.2020.103950']
2804,32957253,Fatigue performance of fully-stabilized zirconia polycrystals monolithic restorations: The effects of surface treatments at the bonding surface.,"This study evaluated the distinct conditioning effect of the intaglio surface of bonded fully-stabilized zirconia (FSZ) simplified restorations on the mechanical fatigue behavior of the set prior to and after aging. Ceramic disc shaped specimens (Ø= 10 mm and 1 mm thick) were randomly allocated into 14 groups considering: ""surface treatments"" (Ctrl: no-treatment; PM: universal primer; GLZ: low-fusing porcelain glaze; SNF: 5 nm SiO 2  nanofilm deposition; AlOx: air-abrasion with aluminum oxide; SiC: air-abrasion with silica-coated aluminum oxide; 7%Si: air-abrasion with 7% silica-coated aluminum oxide); and ""aging"" (baseline: 24 h at 37 °C in water; or aged: 90 days at 37 °C in water + 12,000 thermal cycles). The discs were treated, luted with resin cement onto the dentin analog, subjected to aging or not, and then tested under a step-stress fatigue test at 20 Hz, 10,000 cycles/step, step-size of 100N starting at 200N, and proceeding until failure detection. Fractographic, topographic, surface roughness, contact angle, and atomic force microscopy analyzes were performed. The surface treatments at baseline led to statistically similar fatigue failure loads (953N-1313N), except for GLZ (1313N), which was significantly higher than 7%Si (953 N). Meanwhile, Ctrl had 40% pre-test failures (debonding) after aging, and therefore the worst fatigue performance (notable decrease in fatigue results), while all the other groups presented superior and statistically similar fatigue behavior (973-1271N). In fact, when considering baseline Vs aging conditions, stable fatigue results could only be noted when using surface treatments. In conclusion, internal surface treatments of FSZ ceramic restorations are mandatory for fatigue behavior stability after aging the restorative set, while non-treatment induced unstable results.",2020,"The surface treatments at baseline led to statistically similar fatigue failure loads (953N-1313N), except for GLZ (1313N), which was significantly higher than 7%Si (953 N).","['fully-stabilized zirconia polycrystals monolithic restorations', 'Ceramic disc shaped specimens (Ø= 10\xa0mm and 1\xa0mm thick']","['surface treatments"" (Ctrl: no-treatment; PM: universal primer; GLZ: low-fusing porcelain glaze; SNF: 5\xa0nm SiO 2  nanofilm deposition; AlOx: air-abrasion with aluminum oxide; SiC: air-abrasion with silica-coated aluminum oxide; 7%Si: air-abrasion with 7% silica-coated aluminum oxide); and ""aging"" (baseline: 24\xa0h at 37\xa0°C in water; or aged: 90 days at 37\xa0°C in water\xa0+\xa012,000 thermal cycles', 'FSZ ceramic restorations', 'bonded fully-stabilized zirconia (FSZ) simplified restorations']","['Fractographic, topographic, surface roughness, contact angle, and atomic force microscopy analyzes', 'worst fatigue performance', 'mechanical fatigue behavior', 'Fatigue performance', 'fatigue behavior', 'fatigue behavior stability']","[{'cui': 'C0184512', 'cui_str': 'Stabilized'}, {'cui': 'C0078814', 'cui_str': 'zirconium oxide'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0007742', 'cui_str': 'Ceramic'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C1280412', 'cui_str': 'Thick'}]","[{'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C0206415', 'cui_str': 'Oligonucleotide Primers'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0011392', 'cui_str': 'Dental porcelain material'}, {'cui': 'C0333562', 'cui_str': 'Deposition'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0518443', 'cui_str': 'Abrasion and/or friction burn of skin'}, {'cui': 'C0002374', 'cui_str': 'Aluminum Oxide'}, {'cui': 'C0037098', 'cui_str': 'Silicon Dioxide'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0184512', 'cui_str': 'Stabilized'}, {'cui': 'C0078814', 'cui_str': 'zirconium oxide'}, {'cui': 'C0007742', 'cui_str': 'Ceramic'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}]","[{'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0242849', 'cui_str': 'Atomic Force Microscopy'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]",,0.0285306,"The surface treatments at baseline led to statistically similar fatigue failure loads (953N-1313N), except for GLZ (1313N), which was significantly higher than 7%Si (953 N).","[{'ForeName': 'Ana Carolina', 'Initials': 'AC', 'LastName': 'Cadore-Rodrigues', 'Affiliation': 'Oral Science, Federal University of Santa Maria, Santa Maria, Rio Grande do Sul State, Brazil. Electronic address: anacadorerodrigues@gmail.com.'}, {'ForeName': 'Pablo Soares', 'Initials': 'PS', 'LastName': 'Machado', 'Affiliation': 'Oral Science, Federal University of Santa Maria, Santa Maria, Rio Grande do Sul State, Brazil. Electronic address: P17_SM@hotmail.com.'}, {'ForeName': 'Jivago Schumacher de', 'Initials': 'JS', 'LastName': 'Oliveira', 'Affiliation': 'Chemical Engineering, Federal University of Santa Maria, Santa Maria, Rio Grande do Sul State, Brazil. Electronic address: jivago.s.o@hotmail.com.'}, {'ForeName': 'Sérgio Luiz', 'Initials': 'SL', 'LastName': 'Jahn', 'Affiliation': 'Chemical Engineering, Federal University of Santa Maria, Santa Maria, Rio Grande do Sul State, Brazil. Electronic address: sergiojahn@gmail.com.'}, {'ForeName': 'Gustavo Luiz', 'Initials': 'GL', 'LastName': 'Callegari', 'Affiliation': 'Physics Department, Federal University of Santa Maria, Santa Maria, Brazil. Electronic address: glcallegari@gmail.com.'}, {'ForeName': 'Lucio Strazzabosco', 'Initials': 'LS', 'LastName': 'Dorneles', 'Affiliation': 'Physics Department, Federal University of Santa Maria, Santa Maria, Brazil. Electronic address: lsdorneles@gmail.com.'}, {'ForeName': 'Thiago Augusto de Lima', 'Initials': 'TAL', 'LastName': 'Burgo', 'Affiliation': 'Physics Department, Federal University of Santa Maria, Santa Maria, Brazil. Electronic address: burgounicamp@gmail.com.'}, {'ForeName': 'Marilia Pivetta', 'Initials': 'MP', 'LastName': 'Rippe', 'Affiliation': 'Post-Graduate Program in Oral Science, Prosthodontic Unit, Federal University of Santa Maria, Santa Maria, Rio Grande do Sul State, Brazil. Electronic address: mariliarip@hotmail.com.'}, {'ForeName': 'Gabriel Kalil', 'Initials': 'GK', 'LastName': 'Rocha Pereira', 'Affiliation': 'Oral Science, Federal University of Santa Maria, Santa Maria, Rio Grande do Sul State, Brazil. Electronic address: gabrielkrpereira@hotmail.com.'}, {'ForeName': 'Luiz Felipe', 'Initials': 'LF', 'LastName': 'Valandro', 'Affiliation': 'Oral Science, Federal University of Santa Maria, Santa Maria, Rio Grande do Sul State, Brazil. Electronic address: valandrolf@gmail.com.'}]",Journal of the mechanical behavior of biomedical materials,['10.1016/j.jmbbm.2020.103962']
2805,32959786,Mobile-Enhanced Prevention Support Study for Men Who Have Sex With Men and Transgender Women Leaving Jail: Protocol for a Randomized Controlled Trial.,"BACKGROUND


Men who have sex with men (MSM) and transgender women, particularly those who have experienced criminal justice involvement, have particularly high HIV burdens, and a majority of those in jail have substance use disorders (SUDs). MSM and transgender women also experience elevated rates of incarceration. Once community re-entry occurs, individuals are in a critical period for addressing potential risks of HIV and sexually transmitted infection (STI) acquisition and negative sequelae of substance use. Further, the impact experienced by one's social and sexual networks experienced at the time of detention and release have important health implications for MSM and transgender women.
OBJECTIVE


The purpose of this study is to test a new intervention-Mobile-Enhanced Prevention Support (MEPS)-that involves a GPS-based mobile app called GeoPassport (referred to as GeoPass in practice), incentives, and peer support for promoting HIV prevention, substance use treatment, and use of related services.
METHODS


A two-arm, unblinded, randomized controlled trial will seek to enroll 300 HIV-negative MSM and transgender women, aged 18-49 years, with SUDs, who are either in jail or have recently left jail. Participants will be enrolled by study staff and randomized to the MEPS intervention group or usual care group. The intervention group will receive customized wellness goals in addition to GeoPass, cash incentives, and the support of a trained peer mentor for 6 months. Data collection will consist of a baseline survey and three follow-up surveys at 3, 6, and 9 months postenrollment, either in person or by phone or videoconference when necessary. The primary outcomes include establishing a primary care provider; being prescribed and adhering to pre-exposure prophylaxis (PrEP) for HIV; screening for HIV, STIs, and hepatitis C virus; and engagement in recommended treatment for SUDs. Secondary outcomes include obtaining treatment for any identified infections and avoiding recidivism.
RESULTS


Enrollment began in November 2019 and study completion is expected in 2023.
CONCLUSIONS


This study will advance our knowledge base on patient navigation and peer mentor interventions. Peer navigation services have been studied for the treatment of HIV, but less often in the context of HIV and STI prevention among sexual and gender minority populations at the time of re-entry into the community from jail. The MEPS study will examine the acceptability and feasibility of combining peer mentor services with a mobile app to facilitate service utilization and participant-peer mentor communication. MEPS will assess patterns of PrEP uptake and utilization in MSM and transgender women leaving jail. The study will provide heretofore unavailable data from persons leaving jail regarding HIV PrEP, STI screening, substance abuse treatment, and service utilization patterns and experiences, including geocoded data for those in the intervention arm.
TRIAL REGISTRATION


ClinicalTrials.gov (NCT04036396); https://www.clinicaltrials.gov/ct2/show/NCT04036396.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


PRR1-10.2196/18106.",2020,"Once community re-entry occurs, individuals are in a critical period for addressing potential risks of HIV and sexually transmitted infection (STI) acquisition and negative sequelae of substance use.","['Men', 'Men who have sex with men (MSM) and transgender women, particularly those who have experienced criminal justice involvement, have particularly high HIV burdens, and a majority of those in jail have substance use disorders (SUDs', '300 HIV-negative MSM and transgender women, aged 18-49 years, with SUDs, who are either in jail or have recently left jail', 'With Men and Transgender Women Leaving Jail']","['customized wellness goals in addition to GeoPass, cash incentives, and the support of a trained peer mentor for 6 months', 'MEPS', 'new intervention-Mobile-Enhanced Prevention Support (MEPS)-that involves a GPS-based mobile app called GeoPassport', 'Peer navigation services', 'MEPS intervention group or usual care group']","['obtaining treatment for any identified infections and avoiding recidivism', 'establishing a primary care provider; being prescribed and adhering to pre-exposure prophylaxis (PrEP) for HIV; screening for HIV, STIs, and hepatitis C virus; and engagement in recommended treatment for SUDs']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C1319927', 'cui_str': 'Male-to-female transsexual'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0086072', 'cui_str': 'Criminal Justice'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0392751', 'cui_str': 'In prison'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0481430', 'cui_str': 'HIV negative'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0033168', 'cui_str': 'Prisons'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0025369', 'cui_str': 'Mentors'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0272302', 'cui_str': 'Gray platelet syndrome'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0680458', 'cui_str': 'Recidivism'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C2735026', 'cui_str': 'Primary care provider'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0036916', 'cui_str': 'Sexually transmitted infectious disease'}, {'cui': 'C0079500', 'cui_str': 'Hepacivirus'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}]",,0.129595,"Once community re-entry occurs, individuals are in a critical period for addressing potential risks of HIV and sexually transmitted infection (STI) acquisition and negative sequelae of substance use.","[{'ForeName': 'Gabriel G', 'Initials': 'GG', 'LastName': 'Edwards', 'Affiliation': 'Department of General Internal Medicine and Health Services Research, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, CA, United States.'}, {'ForeName': 'Cathy J', 'Initials': 'CJ', 'LastName': 'Reback', 'Affiliation': 'Center for HIV Identification, Prevention, and Treatment Services, University of California, Los Angeles, Los Angeles, CA, United States.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Cunningham', 'Affiliation': 'Department of General Internal Medicine and Health Services Research, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, CA, United States.'}, {'ForeName': 'Charles L', 'Initials': 'CL', 'LastName': 'Hilliard', 'Affiliation': 'Los Angeles Centers for Alcohol and Drug Abuse, Los Angeles, CA, United States.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'McWells', 'Affiliation': 'Los Angeles Centers for Alcohol and Drug Abuse, Los Angeles, CA, United States.'}, {'ForeName': 'Sukrit', 'Initials': 'S', 'LastName': 'Mukherjee', 'Affiliation': 'Department of Preventative and Social Medicine, Charles R Drew University, Los Angeles, CA, United States.'}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Weiss', 'Affiliation': 'Center for HIV Identification, Prevention, and Treatment Services, University of California, Los Angeles, Los Angeles, CA, United States.'}, {'ForeName': 'Nina T', 'Initials': 'NT', 'LastName': 'Harawa', 'Affiliation': 'Department of General Internal Medicine and Health Services Research, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, CA, United States.'}]",JMIR research protocols,['10.2196/18106']
2806,32965226,Game-Based Meditation Therapy to Improve Posttraumatic Stress and Neurobiological Stress Systems in Traumatized Adolescents: Protocol for a Randomized Controlled Trial.,"BACKGROUND


Many adolescents in residential care have been exposed to prolonged traumatic experiences such as violence, neglect, or abuse. Consequently, they suffer from posttraumatic stress. This not only negatively affects psychological and behavioral outcomes (eg, increased anxiety, depression, and aggression) but also has adverse effects on physiological outcomes, in particular on their neurobiological stress systems. Although current evidence-based treatment options are effective, they have their limitations. An alternative to traditional trauma treatment is meditation-based treatment that focuses on stress regulation and relaxation. Muse is a game-based meditation intervention that makes use of adolescents' intrinsic motivation. The neurofeedback element reinforces relaxation abilities.
OBJECTIVE


This paper describes the protocol for a randomized controlled trial in which the goal is to examine the effectiveness of Muse (InteraXon Inc) in reducing posttraumatic stress and normalizing neurobiological stress systems in a sample of traumatized adolescents in residential care.
METHODS


This will be a multicenter, multi-informant, and multimethod randomized controlled trial. Participants will be adolescents (N=80), aged 10 to 18 years, with clinical levels of posttraumatic symptoms, who are randomized to receive either the Muse therapy sessions and treatment as usual (intervention) or treatment as usual alone (control). Data will be collected at 3 measurement instances: pretest (T1), posttest (T2), and at 2-month follow-up. Primary outcomes will be posttraumatic symptoms (self-report and mentor report) and stress (self-report) at posttest. Secondary outcomes will be neurobiological stress parameters under both resting and acute stress conditions, and anxiety, depression, and aggression at posttest. Secondary outcomes also include all measures at 2-month follow-up: posttraumatic symptoms, stress, anxiety, depression aggression, and neurobiological resting parameters.
RESULTS


The medical-ethical committee Arnhem-Nijmegen (NL58674.091.16) approved the trial on November 15, 2017. The study was registered on December 2, 2017. Participant enrollment started in January 2018, and the results of the study are expected to be published in spring or summer 2021.
CONCLUSIONS


Study results will demonstrate whether game-based meditation therapy improves posttraumatic stress and neurobiological stress systems, and whether it is more effective than treatment as usual alone for traumatized adolescents.
TRIAL REGISTRATION


Netherlands Trial Register NL6689 (NTR6859); https://www.trialregister.nl/trial/6689.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/19881.",2020,"This not only negatively affects psychological and behavioral outcomes (eg, increased anxiety, depression, and aggression) but also has adverse effects on physiological outcomes, in particular on their neurobiological stress systems.","['a sample of traumatized adolescents in residential care', 'Participants will be adolescents (N=80), aged 10 to 18 years, with clinical levels of posttraumatic symptoms', 'Traumatized Adolescents']","['Game-Based Meditation Therapy', 'game-based meditation therapy', 'Muse (InteraXon Inc', 'Muse therapy sessions and treatment as usual (intervention) or treatment as usual alone (control']","['posttraumatic symptoms (self-report and mentor report) and stress (self-report', 'neurobiological stress parameters under both resting and acute stress conditions, and anxiety, depression, and aggression at posttest', 'all measures at 2-month follow-up: posttraumatic symptoms, stress, anxiety, depression aggression, and neurobiological resting parameters', 'psychological and behavioral outcomes (eg, increased anxiety, depression, and aggression', 'posttraumatic stress and neurobiological stress systems']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C2366566', 'cui_str': 'Muse'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0025369', 'cui_str': 'Mentors'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]",,0.102227,"This not only negatively affects psychological and behavioral outcomes (eg, increased anxiety, depression, and aggression) but also has adverse effects on physiological outcomes, in particular on their neurobiological stress systems.","[{'ForeName': 'Angela A T', 'Initials': 'AAT', 'LastName': 'Schuurmans', 'Affiliation': 'Behavioural Science Institute, Radboud University, Nijmegen, Netherlands.'}, {'ForeName': 'Karin S', 'Initials': 'KS', 'LastName': 'Nijhof', 'Affiliation': 'Behavioural Science Institute, Radboud University, Nijmegen, Netherlands.'}, {'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Scholte', 'Affiliation': 'Behavioural Science Institute, Radboud University, Nijmegen, Netherlands.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Popma', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Vrije Universiteit medisch centrum De Bascule, Amsterdam, Netherlands.'}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Otten', 'Affiliation': 'Behavioural Science Institute, Radboud University, Nijmegen, Netherlands.'}]",JMIR research protocols,['10.2196/19881']
2807,32965227,Optimizing an Acceptance and Commitment Therapy Microintervention Via a Mobile App With Two Cohorts: Protocol for Micro-Randomized Trials.,"BACKGROUND


Given gaps in the treatment of mental health, brief adaptive interventions have become a public health imperative. Transdiagnostic interventions may be particularly appropriate given high rates of medical comorbidity and the broader reach of transdiagnostic therapies. One such approach utilized herein is acceptance and commitment therapy (ACT), which is focused on increasing engagement with values, awareness, and openness to internal experiences. ACT theory posits that experiential avoidance is at the center of human suffering, regardless of diagnosis, and, as such, seeks to reduce unworkable experiential avoidance.
OBJECTIVE


Our objective is to provide the rationale and protocol for examining the safety, feasibility, and effectiveness of optimizing an ACT-based intervention via a mobile app among two disparate samples, which differ in sociodemographic characteristics and symptom profiles.
METHODS


Twice each day, participants are prompted via a mobile app to complete assessments of mood and activity and are then randomly assigned to an ACT-based intervention or not. These interventions are questions regarding engagement with values, awareness, and openness to internal experiences. Participant responses are recorded. Analyses will examine completion of assessments, change in symptoms from baseline assessment, and proximal change in mood and activity. A primary outcome of interest is proximal change in activity (eg, form and function of behavior and energy consumed by avoidance and values-based behavior) following interventions as a function of time, symptoms, and behavior, where we hypothesize that participants will focus more energy on values-based behaviors. Analyses will be conducted using a weighted and centered least squares approach. Two samples will run concurrently to assess the capacity of optimizing mobile ACT in populations that differ widely in their clinical presentation and sociodemographic characteristics: individuals with bipolar disorder (n=30) and distressed first-generation college students (n=50).
RESULTS


Recruitment began on September 10, 2019, for the bipolar sample and on October 5, 2019, for the college sample. Participation in the study began on October 18, 2019.
CONCLUSIONS


This study examines an ACT-based intervention among two disparate samples. Should ACT demonstrate feasibility and preliminary effectiveness in each sample, a large randomized controlled trial applying ACT across diagnoses and demographics would be indicated. The public health implications of such an approach may be far-reaching.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04098497; https://clinicaltrials.gov/ct2/show/NCT04098497; ClinicalTrials.gov NCT04081662; https://clinicaltrials.gov/ct2/show/NCT04081662.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/17086.",2020,"Two samples will run concurrently to assess the capacity of optimizing mobile ACT in populations that differ widely in their clinical presentation and sociodemographic characteristics: individuals with bipolar disorder (n=30) and distressed first-generation college students (n=50).
",['sociodemographic characteristics: individuals with bipolar disorder (n=30) and distressed first-generation college students (n=50'],['ACT-based intervention or not'],"['proximal change in activity (eg, form and function of behavior and energy consumed by avoidance and values-based behavior) following interventions as a function of time, symptoms, and behavior']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C3887804', 'cui_str': 'Feeling upset'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0029917', 'cui_str': 'Outpatient Commitment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",2.0,0.264177,"Two samples will run concurrently to assess the capacity of optimizing mobile ACT in populations that differ widely in their clinical presentation and sociodemographic characteristics: individuals with bipolar disorder (n=30) and distressed first-generation college students (n=50).
","[{'ForeName': 'Emily B', 'Initials': 'EB', 'LastName': 'Kroska', 'Affiliation': 'Department of Psychological and Brain Sciences, University of Iowa, Iowa City, IA, United States.'}, {'ForeName': 'Sydney', 'Initials': 'S', 'LastName': 'Hoel', 'Affiliation': 'Department of Psychiatry, University of Wisconsin-Madison, Madison, WI, United States.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Victory', 'Affiliation': 'Department of Psychiatry, University of Michigan-Ann Arbor, Ann Arbor, MI, United States.'}, {'ForeName': 'Susan A', 'Initials': 'SA', 'LastName': 'Murphy', 'Affiliation': 'Department of Statistics, Harvard University, Cambridge, MA, United States.'}, {'ForeName': 'Melvin G', 'Initials': 'MG', 'LastName': 'McInnis', 'Affiliation': 'Department of Psychiatry, University of Michigan-Ann Arbor, Ann Arbor, MI, United States.'}, {'ForeName': 'Zachary N', 'Initials': 'ZN', 'LastName': 'Stowe', 'Affiliation': 'Department of Psychiatry, University of Wisconsin-Madison, Madison, WI, United States.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Cochran', 'Affiliation': 'Department of Population Health Sciences, University of Wisconsin-Madison, Madison, WI, United States.'}]",JMIR research protocols,['10.2196/17086']
2808,32935921,Cutaneous adverse events in a randomized controlled trial of flash glucose monitoring among youth with type 1 diabetes mellitus.,"BACKGROUND


The literature regarding flash glucose monitoring (FGM)-associated cutaneous adverse events (AE) is limited.
OBJECTIVES


This study among youth participating in a 6 month randomized controlled trial aimed to compare cutaneous AE between FGM and self-monitored blood glucose (SMBG) use and evaluate premature FGM sensor loss.
METHODS


Patients aged 13 to 20 years with type 1 diabetes were randomized to intervention (FGM and usual care) or control (SMBG and usual care). Participants self-reported cutaneous AEs electronically every 14 days. Reports were analyzed to determine frequency, type, and severity of cutaneous AEs, and evaluate premature sensor loss.
RESULTS


Sixty-four participants were recruited; 33 randomized to FGM and 31 to control. In total, 80 cutaneous AEs were reported (40 in each group); however, the proportion of participants experiencing cutaneous AEs was greater in the FGM group compared to control (58% and 23% respectively, P = .004). FGM participants most frequently reported erythema (50% of AEs), while controls most commonly reported skin hardening (60% of AEs). For FGM users, 80.0% of cutaneous AEs were mild, 17.5% moderate, and 2.5% severe. Among controls, 82.5% of cutaneous AEs were mild and 17.5% moderate. One participant ceased using FGM due to recurring cutaneous AEs. Additionally, over 6 months, 82% of FGM participants experienced at least one premature sensor loss, largely unrelated to a cutaneous AE.
CONCLUSIONS


Cutaneous FGM-associated AEs are common, and mostly rated as mild. However, the majority of users continued FGM despite cutaneous AEs. Awareness of cutaneous complications and mitigation measures may reduce cutaneous AEs and improve the overall experience of FGM.",2020,"FGM participants most frequently reported erythema (50% of AEs), while controls most commonly reported skin hardening (60% of AEs).","['Patients aged 13-20\u2009years with type 1 diabetes', 'Youth with Type 1 Diabetes Mellitus', 'youth participating in a six-month randomized controlled trial (RCT', 'Sixty-four participants were recruited; 33 randomized to']","['Flash Glucose Monitoring', 'intervention (FGM and usual care) or control (SMBG and usual care', 'FGM']","['proportion of participants experiencing cutaneous AEs', 'skin hardening', 'erythema', 'cutaneous adverse events (AE) between FGM and self-monitored blood glucose (SMBG) use and evaluate premature FGM sensor loss', 'premature sensor loss']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4517839', 'cui_str': '64'}]","[{'cui': 'C0085635', 'cui_str': 'Photopsia'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0005803', 'cui_str': 'Self-monitoring of blood glucose'}]","[{'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0085635', 'cui_str': 'Photopsia'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0005803', 'cui_str': 'Self-monitoring of blood glucose'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}]",64.0,0.0741514,"FGM participants most frequently reported erythema (50% of AEs), while controls most commonly reported skin hardening (60% of AEs).","[{'ForeName': 'Brooke L', 'Initials': 'BL', 'LastName': 'Marsters', 'Affiliation': ""Department of Women's and Children's Health, University of Otago, Dunedin, New Zealand.""}, {'ForeName': 'Sara E', 'Initials': 'SE', 'LastName': 'Boucher', 'Affiliation': ""Department of Women's and Children's Health, University of Otago, Dunedin, New Zealand.""}, {'ForeName': 'Barbara C', 'Initials': 'BC', 'LastName': 'Galland', 'Affiliation': ""Department of Women's and Children's Health, University of Otago, Dunedin, New Zealand.""}, {'ForeName': 'Esko J', 'Initials': 'EJ', 'LastName': 'Wiltshire', 'Affiliation': 'Department of Paediatrics and Child Health, University of Otago, Wellington, New Zealand.'}, {'ForeName': 'Martin I', 'Initials': 'MI', 'LastName': 'de Bock', 'Affiliation': 'Department of Paediatrics, University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Tomlinson', 'Affiliation': 'Paediatric Department, Southern District Health Board, Invercargill, New Zealand.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Rayns', 'Affiliation': 'Endocrinology Department, Southern District Health Board, Dunedin, New Zealand.'}, {'ForeName': 'Karen E', 'Initials': 'KE', 'LastName': 'MacKenzie', 'Affiliation': 'Paediatric Department, Canterbury District Health Board, Christchurch, New Zealand.'}, {'ForeName': 'Huan', 'Initials': 'H', 'LastName': 'Chan', 'Affiliation': 'Department of Endocrinology and General Medicine, Canterbury District Health Board, Christchurch, New Zealand.'}, {'ForeName': 'Benjamin J', 'Initials': 'BJ', 'LastName': 'Wheeler', 'Affiliation': ""Department of Women's and Children's Health, University of Otago, Dunedin, New Zealand.""}]",Pediatric diabetes,['10.1111/pedi.13121']
2809,32940689,Circulating Tumor DNA Markers for Early Progression on Fulvestrant With or Without Palbociclib in ER+ Advanced Breast Cancer.,"BACKGROUND


There are no established molecular biomarkers for patients with breast cancer receiving combination endocrine and CDK4/6 inhibitor (CDK4/6i). We aimed to determine whether genomic markers in circulating tumor DNA (ctDNA) can identify patients at higher risk of early progression on fulvestrant therapy with or without palbociclib, a CDK4/6i.
METHODS


PALOMA-3 was a phase III, multicenter, double-blind randomized controlled trial of palbociclib plus fulvestrant (n = 347) vs placebo plus fulvestrant (n = 174) in patients with endocrine-pretreated estrogen receptor-positive (ER+) breast cancer. Pretreatment plasma samples from 459 patients were analyzed for mutations in 17 genes, copy number in 14 genes, and circulating tumor fraction. Progression-free survival (PFS) was compared in patients with circulating tumor fraction above or below a prespecified cutoff of 10% and with or without a specific genomic alteration. All statistical tests were 2-sided.
RESULTS


Patients with high ctDNA fraction had worse PFS on both palbociclib plus fulvestrant (hazard ratio [HR] = 1.62, 95% confidence interval [CI] = 1.17 to 2.24; P = .004) and placebo plus fulvestrant (HR = 1.77, 95% CI = 1.21 to 2.59; P = .004). In multivariable analysis, high-circulating tumor fraction was associated with worse PFS (HR = 1.20 per 10% increase in tumor fraction, 95% CI = 1.09 to 1.32; P < .001), as was TP53 mutation (HR = 1.84, 95% CI = 1.27 to 2.65; P = .001) and FGFR1 amplification (HR = 2.91, 95% CI = 1.61 to 5.25; P < .001). No interaction with treatment randomization was observed.
CONCLUSIONS


Pretreatment ctDNA identified a group of high-risk patients with poor clinical outcome despite the addition of CDK4/6 inhibition. These patients might benefit from inclusion in future trials of escalating treatment, with therapies that may be active in these genomic contexts.",2020,"In multivariable analysis, high-circulating tumor fraction was associated with worse PFS (HR = 1.20 per 10% increase in tumor fraction, 95% CI = 1.09 to 1.32; P < .001), as was TP53 mutation (HR = 1.84, 95% CI = 1.27 to 2.65; P = .001) and FGFR1 amplification (HR = 2.91, 95% CI = 1.61 to 5.25; P < .001).","['ER+ Advanced Breast Cancer', 'patients with breast cancer receiving combination endocrine and CDK4/6 inhibitor (CDK4/6i', 'patients with endocrine-pretreated estrogen receptor-positive (ER+) breast cancer', 'patients at higher risk of early progression on fulvestrant therapy with or without palbociclib, a CDK4/6i', '459 patients were analyzed for mutations in 17 genes, copy number in 14 genes, and circulating tumor fraction']","['palbociclib plus fulvestrant', 'placebo plus fulvestrant', 'Fulvestrant With or Without Palbociclib']","['Progression-free survival (PFS', 'FGFR1 amplification', 'PFS']","[{'cui': 'C0279754', 'cui_str': 'ESR1 positive'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0014136', 'cui_str': 'Structure of endocrine system'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0935916', 'cui_str': 'fulvestrant'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3853822', 'cui_str': 'palbociclib'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}]","[{'cui': 'C3853822', 'cui_str': 'palbociclib'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0935916', 'cui_str': 'fulvestrant'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1527757', 'cui_str': 'FGFR1 protein, human'}]",459.0,0.302989,"In multivariable analysis, high-circulating tumor fraction was associated with worse PFS (HR = 1.20 per 10% increase in tumor fraction, 95% CI = 1.09 to 1.32; P < .001), as was TP53 mutation (HR = 1.84, 95% CI = 1.27 to 2.65; P = .001) and FGFR1 amplification (HR = 2.91, 95% CI = 1.61 to 5.25; P < .001).","[{'ForeName': 'Ben', 'Initials': 'B', 'LastName': ""O'Leary"", 'Affiliation': 'Breast Cancer Now Toby Robins Research Centre, The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Rosalind J', 'Initials': 'RJ', 'LastName': 'Cutts', 'Affiliation': 'Breast Cancer Now Toby Robins Research Centre, The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': 'Pfizer, New York, NY, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Hrebien', 'Affiliation': 'Breast Cancer Now Toby Robins Research Centre, The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Pfizer, New York, NY, USA.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'André', 'Affiliation': 'Department of Medical Oncology, Institut Gustave Roussy, Université Paris Sud, Villejuif, France.'}, {'ForeName': 'Sibylle', 'Initials': 'S', 'LastName': 'Loibl', 'Affiliation': 'German Breast Group, Martin Behaim-Strasse 12, Neu-Isenburg, Germany.'}, {'ForeName': 'Sherene', 'Initials': 'S', 'LastName': 'Loi', 'Affiliation': 'Division of Research and Cancer Medicine, Peter MacCallum Cancer Centre, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Isaac', 'Initials': 'I', 'LastName': 'Garcia-Murillas', 'Affiliation': 'Breast Cancer Now Toby Robins Research Centre, The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Cristofanilli', 'Affiliation': 'Robert H Lurie Comprehensive Cancer Centre, Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Cynthia Huang', 'Initials': 'CH', 'LastName': 'Bartlett', 'Affiliation': 'Pfizer, New York, NY, USA.'}, {'ForeName': 'Nicholas C', 'Initials': 'NC', 'LastName': 'Turner', 'Affiliation': 'Breast Cancer Now Toby Robins Research Centre, The Institute of Cancer Research, London, UK.'}]",Journal of the National Cancer Institute,['10.1093/jnci/djaa087']
2810,32942555,"Intradialytic Cardiovascular Exercise Training Alters Redox Status, Reduces Inflammation and Improves Physical Performance in Patients with Chronic Kidney Disease.","Redox status (RS) perturbations and inflammation are fundamental features of chronic kidney disease (CKD) that are substantially exacerbated in end-stage renal disease (ESRD). This study aimed at investigating the efficacy of a 6-month intradialytic exercise training program on RS, inflammation and physical performance in patients with ESRD. Twenty hemodialysis (HD) patients (17 males, three females) were randomly assigned to either an intradialytic training (bedside cycling) group (TR;  n  = 10) or a control group (CON;  n  = 10) for 6 months. Anthropometrics [body mass and height, body mass index (BMI), body composition], physical performance (VO 2peak ), functional capacity [North Staffordshire Royal Infirmary (NSRI) walk test, sit-to-stand test (STS-60)], quality of life (short form-36 (SF-36) as well as RS [thiobarbituric acid reactive substances (TBARS), protein carbonyls (PC), reduced (GSH) and oxidized (GSSG) glutathione, GSH/GSSG, total antioxidant capacity (TAC), catalase activity (CAT)] and high-sensitivity C-reactive protein (hs-CRP) were assessed at baseline and after the 6-month intervention. Peak oxygen consumption (VO 2peak ) increased by 15% only in TR ( p  < 0.01). Performance in NSRI, STS-60 and SF-36 improved by 4-13% only in TR ( p  < 0.01). Exercise training reduced TBARS (by 28%), PC (by 31%) and hs-CRP (by 15%), and elevated GSH (by 52%), GSH/GSSG (by 51%), TAC (by 59%) and CAT (by 15%) ( p  < 0.01). These findings suggest that engagement in chronic intradialytic cardiovascular exercise alters RS, reduces inflammation and improves performance in patients with ESRD.",2020,"Performance in NSRI, STS-60 and SF-36 improved by 4-13% only in TR ( p  < 0.01).","['Twenty hemodialysis (HD) patients (17 males, three females', 'patients with ESRD', 'Patients with Chronic Kidney Disease']","['intradialytic training (bedside cycling) group (TR;  n  = 10) or a control group (CON', 'Intradialytic Cardiovascular Exercise Training', 'intradialytic exercise training program']","['Physical Performance', 'TBARS', 'GSH/GSSG', 'elevated GSH', 'TAC', 'Anthropometrics [body mass and height, body mass index (BMI), body composition], physical performance (VO 2peak ), functional capacity [North Staffordshire Royal Infirmary (NSRI) walk test, sit-to-stand test (STS-60)], quality of life (short form-36 (SF-36) as well as RS [thiobarbituric acid reactive substances (TBARS), protein carbonyls (PC), reduced (GSH) and oxidized (GSSG) glutathione, GSH/GSSG, total antioxidant capacity (TAC), catalase activity (CAT)] and high-sensitivity C-reactive protein (hs-CRP', 'Performance in NSRI, STS-60 and SF-36', 'RS, inflammation and physical performance', 'hs-CRP', 'PC', 'Peak oxygen consumption (VO 2peak ']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0162781', 'cui_str': 'TBARs'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0061516', 'cui_str': 'Glutathione Disulfide'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C3489891', 'cui_str': 'TAC Alternate'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0454875', 'cui_str': 'Staffordshire'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0007367', 'cui_str': 'CATALASE'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}]",,0.0179865,"Performance in NSRI, STS-60 and SF-36 improved by 4-13% only in TR ( p  < 0.01).","[{'ForeName': 'Apostolos', 'Initials': 'A', 'LastName': 'Sovatzidis', 'Affiliation': 'Department of Nephrology, Faculty of Medicine, University Hospital of Alexandroupolis, Democritus University of Thrace, 68100 Alexandroupolis, Greece.'}, {'ForeName': 'Athanasios', 'Initials': 'A', 'LastName': 'Chatzinikolaou', 'Affiliation': 'School of Physical Education and Sport Sciences, Democritus University of Thrace, 69100 Komotini, Greece.'}, {'ForeName': 'Ioannis G', 'Initials': 'IG', 'LastName': 'Fatouros', 'Affiliation': 'School of Physical Education and Sport Sciences, University of Thessaly, Karies, 42100 Trikala, Greece.'}, {'ForeName': 'Stylianos', 'Initials': 'S', 'LastName': 'Panagoutsos', 'Affiliation': 'Department of Nephrology, Faculty of Medicine, University Hospital of Alexandroupolis, Democritus University of Thrace, 68100 Alexandroupolis, Greece.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Draganidis', 'Affiliation': 'School of Physical Education and Sport Sciences, University of Thessaly, Karies, 42100 Trikala, Greece.'}, {'ForeName': 'Eirini', 'Initials': 'E', 'LastName': 'Nikolaidou', 'Affiliation': 'Department of Plastic, Reconstructive and Hand Surgery & Burns ICU, General Hospital of Thessaloniki ""G. Papanikolaou"", 57010 Thessaloniki, Greece.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Avloniti', 'Affiliation': 'School of Physical Education and Sport Sciences, Democritus University of Thrace, 69100 Komotini, Greece.'}, {'ForeName': 'Yiannis', 'Initials': 'Y', 'LastName': 'Michailidis', 'Affiliation': 'School of Physical Education and Sport Sciences, Democritus University of Thrace, 69100 Komotini, Greece.'}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Mantzouridis', 'Affiliation': 'School of Physical Education and Sport Sciences, Democritus University of Thrace, 69100 Komotini, Greece.'}, {'ForeName': 'Alexios', 'Initials': 'A', 'LastName': 'Batrakoulis', 'Affiliation': 'School of Physical Education and Sport Sciences, University of Thessaly, Karies, 42100 Trikala, Greece.'}, {'ForeName': 'Ploumis', 'Initials': 'P', 'LastName': 'Pasadakis', 'Affiliation': 'Department of Nephrology, Faculty of Medicine, University Hospital of Alexandroupolis, Democritus University of Thrace, 68100 Alexandroupolis, Greece.'}, {'ForeName': 'Vassilis', 'Initials': 'V', 'LastName': 'Vargemezis', 'Affiliation': ''}]","Antioxidants (Basel, Switzerland)",['10.3390/antiox9090868']
2811,32942627,Evaluation of Food-Intake Behavior in a Healthy Population: Personalized vs. One-Size-Fits-All.,"In public health initiatives, generic nutrition advice (GNA) from national guidelines has a limited effect on food-intake improvement. Personalized nutrition advice (PNA) may enable dietary behavior change. A monocentric, randomized, parallel, controlled clinical trial was performed in males ( n  = 55) and females ( n  = 100) aged 25 to 70 years. Participants were allocated to control, GNA or PNA groups. The PNA group consisted of automatically generated dietary advice based on personal metabolic health parameters, dietary intake, anthropometric and hemodynamic measures, gender and age. Participants who received PNA ( n  = 51) improved their nutritional intake status for fruits  P  ( p  < 0.0001), whole grains ( p  = 0.008), unsalted nuts ( p  < 0.0001), fish ( p  = 0.0003), sugar-sweetened beverages ( p  = 0.005), added salt ( p  = 0.003) and less unhealthy choices ( p  = 0.002), whereas no improvements were observed in the control and GNA group. PNA participants were encouraged to set a goal for one or multiple food categories. Goal-setting led to greater improvement of food categories within the PNA group including; unsalted nuts ( p  < 0.0001), fruits ( p  = 0.0001), whole grains ( p  = 0.005), fish ( p  = 0.0001), dairy ( p  = 0.007), vegetables ( p  = 0.01) and unhealthy choices ( p  = 0.02). In a healthy population, participants receiving PNA changed their food-intake behavior more favorably than participants receiving GNA or no advice. When personal goals were set, nutritional behavior was more prone to change.",2020,"Participants who received PNA ( n  = 51) improved their nutritional intake status for fruits  P  ( p  < 0.0001), whole grains ( p  = 0.008), unsalted nuts ( p  < 0.0001), fish ( p  =","['a Healthy Population', 'males ( n  = 55) and females ( n  = 100) aged 25 to 70 years']","['PNA', 'control, GNA or PNA', 'Personalized nutrition advice (PNA', 'GNA']","['sugar-sweetened beverages', 'nutritional intake status']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}]","[{'cui': 'C5197754', 'cui_str': 'Sugar-Added Beverages'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",100.0,0.0403269,"Participants who received PNA ( n  = 51) improved their nutritional intake status for fruits  P  ( p  < 0.0001), whole grains ( p  = 0.008), unsalted nuts ( p  < 0.0001), fish ( p  =","[{'ForeName': 'Femke P M', 'Initials': 'FPM', 'LastName': 'Hoevenaars', 'Affiliation': 'TNO, Netherlands Organization for Applied Scientific Research, Research Group Microbiology & Systems Biology, P.O. Box 360, 3700 AJ Zeist, The Netherlands.'}, {'ForeName': 'Charlotte M M', 'Initials': 'CMM', 'LastName': 'Berendsen', 'Affiliation': 'TNO, Netherlands Organization for Applied Scientific Research, Research Group Microbiology & Systems Biology, P.O. Box 360, 3700 AJ Zeist, The Netherlands.'}, {'ForeName': 'Wilrike J', 'Initials': 'WJ', 'LastName': 'Pasman', 'Affiliation': 'TNO, Netherlands Organization for Applied Scientific Research, Research Group Microbiology & Systems Biology, P.O. Box 360, 3700 AJ Zeist, The Netherlands.'}, {'ForeName': 'Tim J', 'Initials': 'TJ', 'LastName': 'van den Broek', 'Affiliation': 'TNO, Netherlands Organization for Applied Scientific Research, Research Group Microbiology & Systems Biology, P.O. Box 360, 3700 AJ Zeist, The Netherlands.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Barrat', 'Affiliation': 'Laboratoire Lescuyer, Department of Research, 15 rue le Corbusier, CEDEX, F-17442 Aytré, France.'}, {'ForeName': 'Iris M', 'Initials': 'IM', 'LastName': 'de Hoogh', 'Affiliation': 'TNO, Netherlands Organization for Applied Scientific Research, Research Group Microbiology & Systems Biology, P.O. Box 360, 3700 AJ Zeist, The Netherlands.'}, {'ForeName': 'Suzan', 'Initials': 'S', 'LastName': 'Wopereis', 'Affiliation': 'TNO, Netherlands Organization for Applied Scientific Research, Research Group Microbiology & Systems Biology, P.O. Box 360, 3700 AJ Zeist, The Netherlands.'}]",Nutrients,['10.3390/nu12092819']
2812,32944971,Group acceptance and commitment therapy for patients and caregivers in psychosis services: Feasibility of training and a preliminary randomized controlled evaluation.,"OBJECTIVE


Psychological interventions reduce the impact of psychosis, but widescale implementation is problematic. We tested the feasibility of group acceptance and commitment therapy for Psychosis (G-ACTp), delivered by frontline staff, and co-facilitated by service-user experts-by-experience (SU-EbyE), for service-users and informal caregivers (ISRCTN: 68540929). We estimated recruitment/retention rates and outcome variability for future evaluation.
METHODS


Staff and SU-EbyE facilitators completed 1-day workshops, then delivered closely supervised G-ACTp, comprising four sessions (weeks 1-4) and two boosters (10 and 12 weeks). Participants recruited from adult community psychosis services were randomized to receive G-ACTp immediately or after 12 weeks, completing outcome assessments at 0, 4, and 12 weeks. Service-use/month was calculated for 1-year pre-randomization, weeks 0-12, and 5-year uncontrolled follow-up.
RESULTS


Of 41 facilitators trained (29 staff, 12 SU-EbyE), 29 (71%; 17 staff, 12 SU-EbyE) delivered 18 G-ACTp courses. Participant refusal rates were low (9% of service-users [10/112]; 5% of caregivers [4/79]); 60% of those invited to participate attended ≥1 G-ACTp session (64% of service-users [39/61]; 56% of caregivers [35/63]). Randomization of facilitators and participants proved problematic and participant follow-up was incomplete (78% [66/85]; 82% of service-users [36/44]; 73% of caregivers [30/41]). Effect sizes ranged from very small to large mostly favouring treatment. Service-use reductions require cautious interpretation, as very few participants incurred costs.
CONCLUSIONS


Implementation appears feasible for service-users; for caregivers, retention needs improving. Outcome variability indicated n = 100-300/arm followed up (α = 0.05, 90% power). Methodological limitations' mean replication is needed: identified sources of potential bias may be reduced in a cluster randomized design with sessional outcome completion.
PRACTITIONER POINTS


Group acceptance and commitment therapy can be successfully adapted for people with psychosis and their caregivers. Implementation (training and delivery) is possible in routine community mental health care settings. Clinical and economic outcomes are promising, but replication is needed. Recommendations are made for future studies.",2020,Randomization of facilitators and participants proved problematic and participant follow-up was incomplete (78% [66/85]; 82% of service-users [36/44]; 73% of caregivers [30/41]).,"['people with psychosis and their caregivers', 'patients and caregivers in psychosis services', 'Participants recruited from adult community psychosis services']",['G-ACTp'],['Participant refusal rates'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3658321', 'cui_str': 'Acceptance and commitment therapy'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}]","[{'cui': 'C0040809', 'cui_str': 'Refusal of treatment by patient'}]",,0.209622,Randomization of facilitators and participants proved problematic and participant follow-up was incomplete (78% [66/85]; 82% of service-users [36/44]; 73% of caregivers [30/41]).,"[{'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Jolley', 'Affiliation': ""Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience, King's College London, UK.""}, {'ForeName': 'Louise C', 'Initials': 'LC', 'LastName': 'Johns', 'Affiliation': ""Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience, King's College London, UK.""}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': ""O'Donoghue"", 'Affiliation': ""Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience, King's College London, UK.""}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Oliver', 'Affiliation': 'University College London, UK.'}, {'ForeName': 'Mizanur', 'Initials': 'M', 'LastName': 'Khondoker', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Majella', 'Initials': 'M', 'LastName': 'Byrne', 'Affiliation': ""Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience, King's College London, UK.""}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Butler', 'Affiliation': ""Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience, King's College London, UK.""}, {'ForeName': 'Carmine', 'Initials': 'C', 'LastName': 'De Rosa', 'Affiliation': 'South London and Maudsley NHS Foundation Trust, London, UK.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Leal', 'Affiliation': 'South London and Maudsley NHS Foundation Trust, London, UK.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'McGovern', 'Affiliation': ""Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience, King's College London, UK.""}, {'ForeName': 'Brigita', 'Initials': 'B', 'LastName': 'Rasiukeviciute', 'Affiliation': ""Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience, King's College London, UK.""}, {'ForeName': 'Faye', 'Initials': 'F', 'LastName': 'Sim', 'Affiliation': 'South London and Maudsley NHS Foundation Trust, London, UK.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Morris', 'Affiliation': 'School of Psychology and Public Health, La Trobe University, Melbourne, Victoria, Australia.'}]",The British journal of clinical psychology,['10.1111/bjc.12265']
2813,32941098,The precision interventions for severe and/or exacerbation-prone asthma (PrecISE) adaptive platform trial: statistical considerations.,"The Precision Interventions for Severe and/or Exacerbation-prone Asthma (PrecISE) study is an adaptive platform trial designed to investigate novel interventions to severe asthma. The study is conducted under a master protocol and utilizes a crossover design with each participant receiving up to five interventions and at least one placebo. Treatment assignments are based on the patients' biomarker profiles and precision health methods are incorporated into the interim and final analyses. We describe key elements of the PrecISE study including the multistage adaptive enrichment strategy, early stopping of an intervention for futility, power calculations, and the primary analysis strategy.",2020,The Precision Interventions for Severe and/or Exacerbation-prone Asthma (PrecISE) study is an adaptive platform trial designed to investigate novel interventions to severe asthma.,[],['placebo'],[],[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.032153,The Precision Interventions for Severe and/or Exacerbation-prone Asthma (PrecISE) study is an adaptive platform trial designed to investigate novel interventions to severe asthma.,"[{'ForeName': 'Anastasia', 'Initials': 'A', 'LastName': 'Ivanova', 'Affiliation': 'University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'Elliot', 'Initials': 'E', 'LastName': 'Israel', 'Affiliation': ""Brigham and Women's Hospital and Harvard Medical School, Boston, MA.""}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'LaVange', 'Affiliation': ""Brigham and Women's Hospital and Harvard Medical School, Boston, MA.""}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Peters', 'Affiliation': 'University of California, San Francisco.'}, {'ForeName': 'Loren C', 'Initials': 'LC', 'LastName': 'Denlinger', 'Affiliation': 'University of Wisconsin, Madison.'}, {'ForeName': 'Wendy C', 'Initials': 'WC', 'LastName': 'Moore', 'Affiliation': 'Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Leonard B', 'Initials': 'LB', 'LastName': 'Bacharier', 'Affiliation': 'Vanderbilt University, Nashville, TN.'}, {'ForeName': 'M Alison', 'Initials': 'MA', 'LastName': 'Marquis', 'Affiliation': 'Vanderbilt University, Nashville, TN.'}, {'ForeName': 'Nathan M', 'Initials': 'NM', 'LastName': 'Gotman', 'Affiliation': 'Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Kosorok', 'Affiliation': 'Vanderbilt University, Nashville, TN.'}, {'ForeName': 'Chalmer', 'Initials': 'C', 'LastName': 'Tomlinson', 'Affiliation': 'Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'David T', 'Initials': 'DT', 'LastName': 'Mauger', 'Affiliation': 'Penn State University, Hershey, PA.'}, {'ForeName': 'Steve N', 'Initials': 'SN', 'LastName': 'Georas', 'Affiliation': 'University of Rochester, Rochester, NY.'}, {'ForeName': 'Rosalind J', 'Initials': 'RJ', 'LastName': 'Wright', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Noel', 'Affiliation': 'Division of Lung Diseases, National Heart, Lung and Blood Institute (NHLBI), National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Gary L', 'Initials': 'GL', 'LastName': 'Rosner', 'Affiliation': 'University of California, San Diego.'}, {'ForeName': 'Praveen', 'Initials': 'P', 'LastName': 'Akuthota', 'Affiliation': 'Asthma and Airway Disease Research Center, University of Arizona, Tucson.'}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Billheimer', 'Affiliation': 'Asthma and Airway Disease Research Center, University of Arizona, Tucson.'}, {'ForeName': 'Eugene R', 'Initials': 'ER', 'LastName': 'Bleecker', 'Affiliation': 'University of South Florida, Tampa, FL.'}, {'ForeName': 'Juan Carlos', 'Initials': 'JC', 'LastName': 'Cardet', 'Affiliation': 'University of Kansas School of Medicine, Kansas City.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Castro', 'Affiliation': 'Columbia University, New York, NY.'}, {'ForeName': 'Emily A', 'Initials': 'EA', 'LastName': 'DiMango', 'Affiliation': 'Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'Serpil C', 'Initials': 'SC', 'LastName': 'Erzurum', 'Affiliation': 'Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'John V', 'Initials': 'JV', 'LastName': 'Fahy', 'Affiliation': 'University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Merritt L', 'Initials': 'ML', 'LastName': 'Fajt', 'Affiliation': 'Wells Center for Pediatric Research, Indiana University, Indianapolis.'}, {'ForeName': 'Benjamin M', 'Initials': 'BM', 'LastName': 'Gaston', 'Affiliation': 'Wells Center for Pediatric Research, Indiana University, Indianapolis.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Holguin', 'Affiliation': 'University of Colorado School of Medicine, Aurora.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Jain', 'Affiliation': 'University of California, Davis.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Kenyon', 'Affiliation': 'University of Illinois, Chicago.'}, {'ForeName': 'Jerry A', 'Initials': 'JA', 'LastName': 'Krishnan', 'Affiliation': ""Lurie Children's Hospital, Chicago, IL.""}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Kraft', 'Affiliation': ""Lurie Children's Hospital, Chicago, IL.""}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Kumar', 'Affiliation': 'Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Mark C', 'Initials': 'MC', 'LastName': 'Liu', 'Affiliation': 'Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Ngoc P', 'Initials': 'NP', 'LastName': 'Ly', 'Affiliation': 'Rush University Medical Center, Chicago, IL.'}, {'ForeName': 'James N', 'Initials': 'JN', 'LastName': 'Moy', 'Affiliation': ""Boston Children's Hospital and Harvard Medical School, Boston, MA.""}, {'ForeName': 'Wanda', 'Initials': 'W', 'LastName': 'Phipatanakul', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Kristie', 'Initials': 'K', 'LastName': 'Ross', 'Affiliation': ""UH Rainbow Babies and Children's Hospitals, Cleveland, OH.""}, {'ForeName': 'Lewis J', 'Initials': 'LJ', 'LastName': 'Smith', 'Affiliation': 'Northwestern University, Chicago, IL.'}, {'ForeName': 'Stanley J', 'Initials': 'SJ', 'LastName': 'Szefler', 'Affiliation': ""Children's Hospital Colorado and University of Colorado School of Medicine, Aurora, CO.""}, {'ForeName': 'W Gerald', 'Initials': 'WG', 'LastName': 'Teague', 'Affiliation': 'University of Virginia, Charlottesville.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Wechsler', 'Affiliation': 'University of Chicago, Chicago, IL.'}, {'ForeName': 'Sally E', 'Initials': 'SE', 'LastName': 'Wenzel', 'Affiliation': 'National Jewish Health, Denver, CO, and University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Steven R', 'Initials': 'SR', 'LastName': 'White', 'Affiliation': 'National Jewish Health, Denver, CO, and University of Colorado School of Medicine, Aurora, CO.'}]",Journal of biopharmaceutical statistics,['10.1080/10543406.2020.1821705']
2814,32942192,Cluster randomized controlled trial (RCT) to support parental contact for children in out-of-home care.,"BACKGROUND


There is an identified need to improve the evidence-base in relation to contact visits for children in the out-of-home-care (OOHC) system, to ensure optimal outcomes.
OBJECTIVE


The aim of this cluster randomized controlled trial (RCT) was to test the effectiveness of a contact intervention for parents having supervised contact with children in long-term OOHC.
PARTICIPANTS


183 study children in 15 clusters (OOHC services) and their parent(s) were randomized to the intervention (8 clusters, 100 children) and control groups (7 clusters, 83 children) in three Australian jurisdictions.
SETTING


The manualized intervention consisted of increasing the preparation and support provided by caseworkers to parents before and after their contact visits.
METHOD


Interviews were conducted with carers, parents and caseworkers of the study children at baseline and nine months post-randomization. Interviews included standardized assessment tools measuring child and adult wellbeing and relationships, carer and caseworker ability to support contact, and contact visit cancellations by the parent.
RESULTS


Compared with controls, the intention-to-treat (ITT) analyses showed that fewer visits were cancelled by parents in the intervention group at follow-up (-10.27; 95 % CI: -17.04 to -3.50, p = .006). In addition, per-protocol (PP) analyses showed higher caseworker receptivity to contact (6.03; 95 % CI: 0.04-12.03, p = .04), and higher parent satisfaction with contact (7.41; 95 % CI: 0.70-14.11, p = .03) in the intervention group at follow-up.
CONCLUSIONS


While the intervention did not have an effect on child wellbeing, as measured by the SDQ, the trial reports significant positive findings and demonstrates the benefits of the kC kContact intervention in providing support to parents to attend contact visits. The findings of the current study provide an important contribution to knowledge in an area where few RCTs have been completed, notwithstanding the null findings.",2020,"While the intervention did not have an effect on child wellbeing, as measured by the SDQ, the trial reports significant positive findings and demonstrates the benefits of the kC kContact intervention in providing support to parents to attend contact visits.","['parents having supervised contact with children in long-term OOHC', 'children in out-of-home care', 'Interviews were conducted with carers, parents and caseworkers of the study children at baseline and nine months post-randomization', '183 study children in 15 clusters (OOHC services) and their parent(s']","['kC kContact intervention', 'contact intervention']","['standardized assessment tools measuring child and adult wellbeing and relationships, carer and caseworker ability to support contact, and contact visit cancellations by the parent', 'caseworker receptivity', 'child wellbeing']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0204977', 'cui_str': 'Home care of patient'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4517615', 'cui_str': '183'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0019855', 'cui_str': 'Services, Home Care'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0030551', 'cui_str': 'Parent'}]",183.0,0.11973,"While the intervention did not have an effect on child wellbeing, as measured by the SDQ, the trial reports significant positive findings and demonstrates the benefits of the kC kContact intervention in providing support to parents to attend contact visits.","[{'ForeName': 'Aino', 'Initials': 'A', 'LastName': 'Suomi', 'Affiliation': 'Institute of Child Protection Studies, The Australian Catholic University, Australia; Research School of Population Health, The Australian National University, Australia.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Lucas', 'Affiliation': 'Institute of Child Protection Studies, The Australian Catholic University, Australia.'}, {'ForeName': 'Morag', 'Initials': 'M', 'LastName': 'McArthur', 'Affiliation': 'Institute of Child Protection Studies, The Australian Catholic University, Australia.'}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Humphreys', 'Affiliation': 'Department of Social Work, The University of Melbourne, Australia.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Dobbins', 'Affiliation': 'School of Public Health and Community Medicine, The University of New South Wales, Australia.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Taplin', 'Affiliation': 'Institute of Child Protection Studies, The Australian Catholic University, Australia. Electronic address: stephanie.taplin@acu.edu.au.'}]",Child abuse & neglect,['10.1016/j.chiabu.2020.104708']
2815,32948200,Phase II multicenter randomized controlled clinical trial on the efficacy of intra-articular injection of autologous bone marrow mesenchymal stem cells with platelet rich plasma for the treatment of knee osteoarthritis.,"BACKGROUND


Mesenchymal stromal cells are a safe and promising option to treat knee osteoarthritis as previously demonstrated in different clinical trials. However, their efficacy, optimal dose and addition of adjuvants must be determined. Here, we evaluated the clinical effects of a dose of 100 × 10 6  bone marrow mesenchymal stromal cells (BM-MSCs) in combination with Platelet Rich Plasma (PRGF®) as adjuvant in a randomized clinical trial.
METHODS


A phase II, multicenter, randomized clinical trial with active control was conducted. Sixty patients diagnosed with knee OA were randomly assigned to 3 weekly doses of PRGF® or intraarticular administration of 100 × 10 6  cultured autologous BM-MSCs plus PRGF®. Patients were followed up for 12 months, and pain and function were assessed using VAS and WOMAC and by measuring the knee range of motion range. X-ray and magnetic resonance imaging analyses were performed to analyze joint damage.
RESULTS


No adverse effects were reported after BM-MSC administration or during follow-up. According to VAS, the mean value (SD) for PRGF® and BM-MSC with PRGF® went from 5 (1.8) to 4.5 (2.2) (p = 0.389) and from 5.3 (1.9) to 3.5 (2.5) (p = 0.01), respectively at 12 months. In WOMAC, the mean (SD) baseline and 12-month overall WOMAC scores in patients treated with PRGF® was 31.9 (16.2) and 22.3 (15.8) respectively (p = 0.002) while that for patients treated with BM-MSC plus PRGF® was 33.4 (18.7) and 23.0 (16.6) (p = 0.053). Although statistical significances between groups have been not detected, only patients being treated with BM-MSC plus PRGF® could be considered as a OA treatment responders following OARSI criteria. X-ray and MRI (WORMS protocol) revealed no changes in knee joint space width or joint damage.
CONCLUSIONS


Treatment with BM-MSC associated with PRGF® was shown to be a viable therapeutic option for osteoarthritis of the knee, with clinical improvement at the end of follow-up. Further phase III clinical trials would be necessary to confirm the efficacy. Trial registration Clinical Trials.gov identifier NCT02365142. Nº EudraCT: 2011-006036-23.",2020,No adverse effects were reported after BM-MSC administration or during follow-up.,"['Sixty patients diagnosed with knee OA', 'knee osteoarthritis']","['PRGF® or intraarticular administration of 100\u2009×\u200910 6  cultured autologous BM-MSCs plus PRGF®', 'intra-articular injection of autologous bone marrow mesenchymal stem cells with platelet rich plasma', '100\u2009×\u200910 6  bone marrow mesenchymal stromal cells (BM-MSCs) in combination with Platelet Rich Plasma (PRGF®', 'X-ray and MRI (WORMS protocol']","['mean (SD) baseline and 12-month overall WOMAC scores', 'pain and function', 'adverse effects', 'knee joint space width or joint damage']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}]","[{'cui': 'C0442108', 'cui_str': 'Intra-articular'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0021488', 'cui_str': 'Intra-articular injection'}, {'cui': 'C4704952', 'cui_str': 'Bone Marrow Mesenchymal Stem Cells'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C3178844', 'cui_str': 'Mesenchymal Stromal Cells'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0018889', 'cui_str': 'Helminth infection'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0022745', 'cui_str': 'Knee joint structure'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0010957', 'cui_str': 'Damage'}]",60.0,0.0966388,No adverse effects were reported after BM-MSC administration or during follow-up.,"[{'ForeName': 'José María', 'Initials': 'JM', 'LastName': 'Lamo-Espinosa', 'Affiliation': 'Department of Orthopaedic Surgery and Traumatology, Clínica Universidad de Navarra, 36 Pío XII Avenue, 31008, Pamplona, Spain. jlamodeespi@unav.es.'}, {'ForeName': 'Juan F', 'Initials': 'JF', 'LastName': 'Blanco', 'Affiliation': 'Department of Orthopaedic Surgery and Traumatology, Complejo Universitario de Salamanca-IBSAL, Salamanca, Spain.'}, {'ForeName': 'Mikel', 'Initials': 'M', 'LastName': 'Sánchez', 'Affiliation': 'Arthroscopic Surgery Unit, Hospital Vithas San José, Vitoria-Gasteiz, Spain.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Moreno', 'Affiliation': 'Department of Orthopaedic Surgery and Traumatology, Clínica Universidad de Navarra, 36 Pío XII Avenue, 31008, Pamplona, Spain.'}, {'ForeName': 'Froilán', 'Initials': 'F', 'LastName': 'Granero-Moltó', 'Affiliation': 'Department of Orthopaedic Surgery and Traumatology, Clínica Universidad de Navarra, 36 Pío XII Avenue, 31008, Pamplona, Spain.'}, {'ForeName': 'Fermín', 'Initials': 'F', 'LastName': 'Sánchez-Guijo', 'Affiliation': 'Department of Haematology, Complejo Hospitalario de Salamanca-IBSAL, Salamanca, Spain.'}, {'ForeName': 'Íñigo', 'Initials': 'Í', 'LastName': 'Crespo-Cullel', 'Affiliation': 'Department of Orthopaedic Surgery and Traumatology, Complejo Universitario de Salamanca-IBSAL, Salamanca, Spain.'}, {'ForeName': 'Gonzalo', 'Initials': 'G', 'LastName': 'Mora', 'Affiliation': 'Department of Orthopaedic Surgery and Traumatology, Clínica Universidad de Navarra, 36 Pío XII Avenue, 31008, Pamplona, Spain.'}, {'ForeName': 'Diego Delgado', 'Initials': 'DD', 'LastName': 'San Vicente', 'Affiliation': 'Advanced Biological Therapy Unit, Hospital Vithas San José, Vitoria-Gasteiz, Spain.'}, {'ForeName': 'Orlando', 'Initials': 'O', 'LastName': 'Pompei-Fernández', 'Affiliation': 'Advanced Biological Therapy Unit, Hospital Vithas San José, Vitoria-Gasteiz, Spain.'}, {'ForeName': 'Jesús Dámaso', 'Initials': 'JD', 'LastName': 'Aquerreta', 'Affiliation': 'Department of Radiology, Clínica Universidad de Navarra, Pamplona, Spain.'}, {'ForeName': 'Jorge María', 'Initials': 'JM', 'LastName': 'Núñez-Córdoba', 'Affiliation': 'Division of Biostatistics, Research Support Service, Central Clinical Trials Unit, Clínica Universidad de Navarra, Pamplona, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Vitoria Sola', 'Affiliation': 'Department of Orthopaedic Surgery and Traumatology, Clínica Universidad de Navarra, 36 Pío XII Avenue, 31008, Pamplona, Spain.'}, {'ForeName': 'Andrés', 'Initials': 'A', 'LastName': 'Valentí-Azcárate', 'Affiliation': 'Department of Orthopaedic Surgery and Traumatology, Clínica Universidad de Navarra, 36 Pío XII Avenue, 31008, Pamplona, Spain.'}, {'ForeName': 'Enrique J', 'Initials': 'EJ', 'LastName': 'Andreu', 'Affiliation': 'Cell Therapy Area, Clínica Universidad de Navarra, 36 Pío XII Avenue, 31008, Pamplona, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Del Consuelo Del Cañizo', 'Affiliation': 'Department of Haematology, Complejo Hospitalario de Salamanca-IBSAL, Salamanca, Spain.'}, {'ForeName': 'Juan Ramón', 'Initials': 'JR', 'LastName': 'Valentí-Nin', 'Affiliation': 'Department of Orthopaedic Surgery and Traumatology, Clínica Universidad de Navarra, 36 Pío XII Avenue, 31008, Pamplona, Spain.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Prósper', 'Affiliation': 'Cell Therapy Area, Clínica Universidad de Navarra, 36 Pío XII Avenue, 31008, Pamplona, Spain. fprosper@unav.es.'}]",Journal of translational medicine,['10.1186/s12967-020-02530-6']
2816,32946885,Training primary care professionals in multimorbidity management: Educational assessment of the eMULTIPAP course.,"Multimorbidity (MM) is a widespread problem and it poses unsolved issues like the healthcare professionals' training. A training curriculum has been proposed, but it has not been sufficiently explored in a clinical context. The eMULTIPAP course is part of the MULTIPAP complex intervention, applied through a pragmatic controlled, cluster randomized clinical trial to general practitioners (GP) and his/her patients with MM with 12 months follow-up. The eMULTIPAP course is based on problem-based learning, constructivism and Ariadne principles. It has been assessed according to the Kirkpatrick model and has shown knowledge improvement and high applicability of learning with more motivation to consider MM in the clinical practice. It has also improved the Medication Appropriateness Index at 6-months and at 12- months. We conclude that the eMULTIPAP course generates significant changes in GP's learning, enhancing clinical practice in multimorbidity scenarios.",2020,"We conclude that the eMULTIPAP course generates significant changes in GP's learning, enhancing clinical practice in multimorbidity scenarios.",['general practitioners (GP) and his/her patients with MM with 12 months follow-up'],"['Multimorbidity (MM', 'eMULTIPAP']","['Medication Appropriateness Index', ""GP's learning""]","[{'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C1535889', 'cui_str': 'Multimorbidity'}]","[{'cui': 'C4046084', 'cui_str': 'Medication Appropriateness Index'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0023185', 'cui_str': 'Learning'}]",,0.0184836,"We conclude that the eMULTIPAP course generates significant changes in GP's learning, enhancing clinical practice in multimorbidity scenarios.","[{'ForeName': 'Francisca', 'Initials': 'F', 'LastName': 'Leiva-Fernández', 'Affiliation': 'Teaching Unit for Family and Community Primary Care Health District Málaga/Guadalhorce, Andalusian Health Service, Málaga, Spain; Biomedical Research Institute of Málaga -IBIMA-, University of Malaga, Spain; Health Services and Chronic Conditions Research Network (REDISSEC), Health Institute Carlos III, Madrid, Spain. Electronic address: francisca.leiva.sspa@juntadeandalucia.es.'}, {'ForeName': 'Juan Daniel', 'Initials': 'JD', 'LastName': 'Prados-Torres', 'Affiliation': 'Teaching Unit for Family and Community Primary Care Health District Málaga/Guadalhorce, Andalusian Health Service, Málaga, Spain; Biomedical Research Institute of Málaga -IBIMA-, University of Malaga, Spain; Health Services and Chronic Conditions Research Network (REDISSEC), Health Institute Carlos III, Madrid, Spain. Electronic address: juand.prados.sspa@juntadeandalucia.es.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Prados-Torres', 'Affiliation': 'Health Services and Chronic Conditions Research Network (REDISSEC), Health Institute Carlos III, Madrid, Spain; EpiChron Research Group, Aragon Health Sciences Institute (IACS), IIS Aragón, Miguel Servet University Hospital, Zaragoza, Spain. Electronic address: sprados.iacs@aragon.es.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Del-Cura-González', 'Affiliation': 'Health Services and Chronic Conditions Research Network (REDISSEC), Health Institute Carlos III, Madrid, Spain; Research Unit, Primary Health Care Management of Madrid, Madrid Health Service, Spain; Public Health and Preventive Medicine Area, University Rey Juan Carlos, Madrid, Spain. Electronic address: isabel.cura@salud.madrid.org.'}, {'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'Castillo-Jimena', 'Affiliation': 'Teaching Unit for Family and Community Primary Care Health District Málaga/Guadalhorce, Andalusian Health Service, Málaga, Spain; Biomedical Research Institute of Málaga -IBIMA-, University of Malaga, Spain; Primary Care Health Centre Coín, Health District Málaga-Guadalhorce, Andalusian Health Service, Málaga, Spain. Electronic address: marcosc.malaga@gmail.com.'}, {'ForeName': 'Juan Antonio', 'Initials': 'JA', 'LastName': 'López-Rodríguez', 'Affiliation': 'Health Services and Chronic Conditions Research Network (REDISSEC), Health Institute Carlos III, Madrid, Spain; Research Unit, Primary Health Care Management of Madrid, Madrid Health Service, Spain; Public Health and Preventive Medicine Area, University Rey Juan Carlos, Madrid, Spain; Primary Care Health Centre General Ricardos, Madrid Health Service, Spain. Electronic address: juanantonio.lopez@salud.madrid.org.'}, {'ForeName': 'Maria Eloísa', 'Initials': 'ME', 'LastName': 'Rogero-Blanco', 'Affiliation': 'Primary Care Health Centre General Ricardos, Madrid Health Service, Spain. Electronic address: mariaeloisa.rogero@salud.madrid.org.'}, {'ForeName': 'Cristina M', 'Initials': 'CM', 'LastName': 'Lozano-Hernández', 'Affiliation': 'Health Services and Chronic Conditions Research Network (REDISSEC), Health Institute Carlos III, Madrid, Spain; Research Unit, Primary Health Care Management of Madrid, Madrid Health Service, Spain. Electronic address: cristinamaria.lozano@salud.madrid.org.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'López-Verde', 'Affiliation': 'Teaching Unit for Family and Community Primary Care Health District Málaga/Guadalhorce, Andalusian Health Service, Málaga, Spain; Primary Care Health Centre Las Delicias, Health District Málaga-Guadalhorce, Andalusian Health Service, Málaga, Spain. Electronic address: flverde@gmail.com.'}, {'ForeName': 'María José', 'Initials': 'MJ', 'LastName': 'Bujalance-Zafra', 'Affiliation': 'Teaching Unit for Family and Community Primary Care Health District Málaga/Guadalhorce, Andalusian Health Service, Málaga, Spain; Biomedical Research Institute of Málaga -IBIMA-, University of Malaga, Spain; Primary Care Health Centre Victoria, Health District Málaga-Guadalhorce, Andalusian Health Service, Málaga, Spain. Electronic address: mjbujalance@hotmail.com.'}, {'ForeName': 'Maria Victoria', 'Initials': 'MV', 'LastName': 'Pico-Soler', 'Affiliation': 'EpiChron Research Group, Aragon Health Sciences Institute (IACS), IIS Aragón, Miguel Servet University Hospital, Zaragoza, Spain; Primary Care Health Centre Torrero-La Paz, Aragon Health Service, Zaragoza, Spain. Electronic address: vpico@salud.aragon.es.'}, {'ForeName': 'Luis Andrés', 'Initials': 'LA', 'LastName': 'Gimeno-Feliu', 'Affiliation': 'EpiChron Research Group, Aragon Health Sciences Institute (IACS), IIS Aragón, Miguel Servet University Hospital, Zaragoza, Spain; Primary Care Health Centre San Pablo. Aragon Health Service, Zaragoza, Spain. Electronic address: lugifel@gmail.com.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Poblador-Plou', 'Affiliation': 'Health Services and Chronic Conditions Research Network (REDISSEC), Health Institute Carlos III, Madrid, Spain; EpiChron Research Group, Aragon Health Sciences Institute (IACS), IIS Aragón, Miguel Servet University Hospital, Zaragoza, Spain. Electronic address: bpoblador.iacs@aragon.es.'}, {'ForeName': 'María Teresa', 'Initials': 'MT', 'LastName': 'Martinez-Cañavate', 'Affiliation': 'IAVANTE: Línea de Formación de la Fundación Progreso y Salud, Junta de Andalucía, Spain. Electronic address: teresa.martinezcanavate@juntadeandalucia.es.'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Muth', 'Affiliation': 'Institute of General Practice, Johann Wolfgang Goethe University, Frankfurt, Germany. Electronic address: muth@allgemeinmedizin.uni-frankfurt.de.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Mechanisms of ageing and development,['10.1016/j.mad.2020.111354']
2817,32946978,Sensory attributes of coated tablets: Developing a formal lexicon and sensory wheel.,"The patient's sensory experience when taking an oral medicine is important in the assessment of its palatability, and acceptability. The aim of this study was to develop tools useful for standardisation of sensory assessment of coated tablets: a lexicon and a sensory wheel. Two randomised, double-blind sensory assessments were performed involving 83 and 52 heathy adult volunteers and two sets of coated tablets. By adapting the principles used by food sciences, a free-text description of conventional, bitter-tasting or tasteless, coated tablets was performed. In the first assessment, volunteers described the sensory attributes of the first set of tablets. The attributes collected were then validated using a second set of tablets in a separate study with different volunteers. The appropriateness and semantics of each sensory attribute was analysed. Twenty attributes most relevant for assessment of coated tablets were selected for the lexicon and associated with explicit definitions. A collection of all attributes that could possibly be triggered by coated tablets were organised in the form of a sensory wheel. This study provides a valuable insight into the sensory experience while taking a coated tablet and presents tools which can accelerate the development of palatable medicines.",2020,"Two randomised, double-blind sensory assessments were performed involving 83 and 52 heathy adult volunteers and two sets of coated tablets.",['52 heathy adult volunteers and two sets of coated tablets'],['coated tablets'],[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0039225', 'cui_str': 'Tablet'}]",[],,0.0459016,"Two randomised, double-blind sensory assessments were performed involving 83 and 52 heathy adult volunteers and two sets of coated tablets.","[{'ForeName': 'J K', 'Initials': 'JK', 'LastName': 'Hofmanová', 'Affiliation': 'School of Pharmacy, University of Birmingham, Edgbaston, Birmingham B15 2TT, United Kingdom.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Mason', 'Affiliation': 'School of Pharmacy, University of Birmingham, Edgbaston, Birmingham B15 2TT, United Kingdom.'}, {'ForeName': 'H K', 'Initials': 'HK', 'LastName': 'Batchelor', 'Affiliation': 'School of Pharmacy, University of Birmingham, Edgbaston, Birmingham B15 2TT, United Kingdom; Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, 161 Cathedral Street, Glasgow G4 0RE, United Kingdom. Electronic address: hannah.batchelor@strath.ac.uk.'}]",International journal of pharmaceutics,['10.1016/j.ijpharm.2020.119883']
2818,32949505,Effect of permanent right internal mammary artery occlusion on right coronary artery supply: A randomized placebo-controlled clinical trial.,"Natural, nonsurgical internal mammary artery (IMA) bypasses to the coronary circulation have been shown to function as extracardiac sources of myocardial blood supply. The goal of this randomized, placebo-controlled, double-blind trial was to test the efficacy of permanent right IMA (RIMA) device occlusion on right coronary artery (RCA) occlusive blood supply and on clinical and electrocardiographic (ECG) signs of myocardial ischemia.
METHODS


This was a prospective superiority trial in 100 patients with chronic coronary artery disease randomly allocated (1:1) to RIMA vascular device occlusion (verum group) or to RIMA sham procedure (placebo group). The primary study end point was RCA collateral flow index (CFI) as obtained during a 1-minute ostial RCA balloon occlusion at baseline before and at follow-up examination 6 weeks after the trial intervention. CFI is the ratio between simultaneous mean coronary occlusive divided by mean aortic pressure both subtracted by central venous pressure. Simultaneously obtained secondary study end points were the registration of angina pectoris and quantitative intracoronary ECG ST-segment shift.
RESULTS


CFI change during the follow-up period was +0.036 ± 0.068 in the verum group and -0.021 ± 0.097 in the placebo group (P = .0011). Angina pectoris during the same RCA balloon occlusions had disappeared at follow-up in 14/49 patients of the verum group and in 4/49 patients of the placebo group (P = .0091). Simultaneous intracoronary ECG ST-segment shift change revealed diminished myocardial ischemia at follow-up in the verum group and more severe ischemia in the placebo group.
CONCLUSIONS


Permanent RIMA device occlusion augments RCA supply to the effect of diminishing clinical and electrocardiographic signs of myocardial ischemia during a brief controlled coronary occlusion.",2020,"ECG ST-segment shift change revealed diminished myocardial ischemia at follow-up in the verum group, and more severe ischemia in the placebo group.
",['100 patients with chronic coronary artery disease (CAD) randomly allocated (1:1) to'],"['permanent right internal mammary artery occlusion', 'permanent right IMA (RIMA) device occlusion', 'placebo', 'RIMA vascular device occlusion (verum group) or to RIMA sham procedure (placebo', 'CFI']","['right coronary artery supply', 'registration of angina pectoris and quantitative intracoronary (i.c', 'myocardial ischemia', 'Angina pectoris', 'RCA collateral flow index (CFI) as obtained during a 1-minute ostial RCA balloon occlusion', 'CFI change', 'severe ischemia']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}]","[{'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0500531', 'cui_str': 'Right internal mammary artery'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C1608397', 'cui_str': 'Device occlusion'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4552248', 'cui_str': 'Vascular device occlusion'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1275670', 'cui_str': 'Collateral branch of vessel'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]","[{'cui': 'C1261316', 'cui_str': 'Right coronary artery structure'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0002962', 'cui_str': 'Angina pectoris'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0595454', 'cui_str': 'Intracoronary route'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C1275670', 'cui_str': 'Collateral branch of vessel'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0887842', 'cui_str': 'Balloon Occlusion'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}]",100.0,0.210404,"ECG ST-segment shift change revealed diminished myocardial ischemia at follow-up in the verum group, and more severe ischemia in the placebo group.
","[{'ForeName': 'Marius R', 'Initials': 'MR', 'LastName': 'Bigler', 'Affiliation': 'Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, 3010 Bern, Switzerland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Stoller', 'Affiliation': 'Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, 3010 Bern, Switzerland.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Tschannen', 'Affiliation': 'Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, 3010 Bern, Switzerland.'}, {'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Grossenbacher', 'Affiliation': 'Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, 3010 Bern, Switzerland.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Seiler', 'Affiliation': 'Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, 3010 Bern, Switzerland. Electronic address: christian.seiler@insel.ch.'}]",American heart journal,['10.1016/j.ahj.2020.09.006']
2819,32954487,Responder Profile to Pharmaceutical-Grade Chondroitin Sulfate: An Analysis of the CONCEPT Trial.,"INTRODUCTION


The recent CONCEPT study showed that 800 mg/day of pharmaceutical-grade chondroitin sulfate (CS) was superior to placebo and similar to celecoxib in reducing pain and improving function over 6 months in patients with symptomatic knee osteoarthritis (OA). We investigate, in the present study, whether a responder profile to CS could be defined (i.e., to determine a patient's profile with the best response to treatment).
METHODS


Subjects from the CS group of the CONCEPT study were included in the present analysis. Within the CS group, various subgroups were created on the basis of different categories of age, sex, body mass index, Kellgren and Lawrence grade, age since the beginning of OA, and baseline level of pain (i.e., VAS) or function (i.e., Lequesne index). The nonparametric Kruskal-Wallis (KW) test was applied to compare the VAS pain/Lequesne index evolutions between the subgroups, and the Dwass, Steel, Critchlow, Fligner (DSCF) procedure was used to compute multiple comparisons. The impact of various covariates on the VAS pain/Lequesne index evolution was assessed by means of multiple regression.
RESULTS


Across all analyses, the probability of response to CS treatment was significantly associated with the duration between the date of diagnosis and the initiation of treatment. In other words, the shorter the interval between the diagnosis and the beginning of the treatment, the higher the response for both pain and function, particularly for patients with a duration of less than 5 years compared to patients with a duration of 10 years or more. No other criteria were found to be consistently associated with the response to CS treatment.
CONCLUSION


The treatment of OA with CS has the highest chance of success if administered in the early stage of the disease. Further research with other clinical outcomes should be carried out prior to widespread application of these findings.
TRIAL REGISTRATION


ClinicalTrials.gov identifier, NCT03200288.",2020,"No other criteria were found to be consistently associated with the response to CS treatment.
","['Subjects from the CS group of the CONCEPT study were included in the present analysis', 'patients with symptomatic knee osteoarthritis (OA']","['OA with CS', 'pharmaceutical-grade chondroitin sulfate (CS', 'placebo', 'celecoxib']","['probability of response to CS treatment', 'Lequesne index evolution', 'pain and improving function', 'VAS pain']","[{'cui': 'C0008466', 'cui_str': 'Chondroitin Sulfates'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}]","[{'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0008466', 'cui_str': 'Chondroitin Sulfates'}, {'cui': 'C0013058', 'cui_str': 'Pharmaceutical dose form'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0538927', 'cui_str': 'celecoxib'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0008466', 'cui_str': 'Chondroitin Sulfates'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0451257', 'cui_str': 'Lequesne index'}, {'cui': 'C0015219', 'cui_str': 'Biological Evolution'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",,0.0274737,"No other criteria were found to be consistently associated with the response to CS treatment.
","[{'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Bruyère', 'Affiliation': 'Division of Public Health, Epidemiology and Health Economics, WHO Collaborating Centre for Public Health Aspects of Musculoskeletal Health and Ageing, University of Liège, Liège, Belgium. olivier.bruyere@uliege.be.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Dardenne', 'Affiliation': 'Department of Biostatistics, University of Liège, Liège, Belgium.'}, {'ForeName': 'Anne-Françoise', 'Initials': 'AF', 'LastName': 'Donneau', 'Affiliation': 'Department of Biostatistics, University of Liège, Liège, Belgium.'}, {'ForeName': 'Jean-Yves', 'Initials': 'JY', 'LastName': 'Reginster', 'Affiliation': 'Division of Public Health, Epidemiology and Health Economics, WHO Collaborating Centre for Public Health Aspects of Musculoskeletal Health and Ageing, University of Liège, Liège, Belgium.'}]",Advances in therapy,['10.1007/s12325-020-01484-x']
2820,32960669,Evaluation of a Tube Voltage-Tailored Contrast Medium Injection Protocol for Coronary CT Angiography: Results From the Prospective VOLCANIC Study.,"OBJECTIVE.  The purpose of this study was to prospectively evaluate, using software support, the feasibility and the quantitative and qualitative image quality parameters of a tube voltage-tailored contrast medium (CM) application protocol for patient-specific injection during coronary CT angiography (CCTA).  SUBJECTS AND METHODS.  In the Voltage-Based Contrast Media Adaptation in Coronary Computed Tomography Angiography (VOLCANIC-CTA) study, a single-center trial, 120 patients referred for CCTA were prospectively assigned to a tube voltage-tailored CM injection protocol. Automated tube voltage levels were selected in 10-kV intervals and ranged from 70 to 130 kV, and the iodine delivery rate (IDR) was adapted to the tube voltage level using dedicated software. The administered CM volume (370 mg I/mL) ranged from 33 mL at 70 kV (IDR, 0.7 g I/s) to 65 mL at 130 kV (IDR, 1.7 g I/s). Attenuation was measured in the aorta and coronary arteries to calculate quantitative signal-to-noise ratio (SNR) and contrast-to-noise ratio (CNR), and 5-point scales were used to evaluate overall image quality. Radiation metrics were also assessed and compared among the protocols.  RESULTS.  The mean age of the study patients was 62.5 ± 11.9 (SD) years. Image quality was rated as diagnostic in all patients. Contrast attenuation peaked at 70 kV ( p  < 0.001), whereas SNR and CNR parameters showed no significant differences between tube voltage levels ( p  ≥ 0.085). Additionally, no significant differences in subjective image quality parameters were found among the different protocols ( p  ≥ 0.139). The lowest radiation dose values were observed in the group assigned to the 70-kV protocol, which had a median radiation effective dose of 2.0 mSv ( p  < 0.001).  CONCLUSION.  The proposed tube voltage-tailored injection protocol allows individualized scanning of patients undergoing CCTA and significantly reduces CM and radiation dose while maintaining a high diagnostic image quality.",2020,The proposed tube voltage-tailored injection protocol allows individualized scanning of patients undergoing CCTA and significantly reduces CM and radiation dose while maintaining a high diagnostic image quality.,"['The mean age of the study patients was 62.5 ± 11.9 (SD) years', 'Coronary CT Angiography', 'patient-specific injection during coronary CT angiography (CCTA', '120 patients referred for CCTA']","['tube voltage-tailored contrast medium (CM) application protocol', 'tube voltage-tailored CM injection protocol', 'Tube Voltage-Tailored Contrast Medium Injection Protocol']","['quantitative signal-to-noise ratio (SNR) and contrast-to-noise ratio (CNR), and 5-point scales', 'Radiation metrics', 'Image quality', 'subjective image quality parameters', 'lowest radiation dose values', 'tube voltage levels', 'iodine delivery rate (IDR']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517836', 'cui_str': '62.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C1536105', 'cui_str': 'CT angiography'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}]","[{'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C2986823', 'cui_str': 'Signal-To-Noise Ratio'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021966', 'cui_str': 'Iodide salt'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}]",120.0,0.0253303,The proposed tube voltage-tailored injection protocol allows individualized scanning of patients undergoing CCTA and significantly reduces CM and radiation dose while maintaining a high diagnostic image quality.,"[{'ForeName': 'Simon S', 'Initials': 'SS', 'LastName': 'Martin', 'Affiliation': 'Department of Radiology and Radiological Science, Division of Cardiovascular Imaging, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Dante A', 'Initials': 'DA', 'LastName': 'Giovagnoli', 'Affiliation': 'Department of Radiology and Radiological Science, Division of Cardiovascular Imaging, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Andres F', 'Initials': 'AF', 'LastName': 'Abadia', 'Affiliation': 'Department of Radiology and Radiological Science, Division of Cardiovascular Imaging, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Vingiani', 'Affiliation': 'Department of Radiology and Radiological Science, Division of Cardiovascular Imaging, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Philipp L von Knebel', 'Initials': 'PLVK', 'LastName': 'Doeberitz', 'Affiliation': 'Department of Radiology and Radiological Science, Division of Cardiovascular Imaging, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Hubert E', 'Initials': 'HE', 'LastName': 'Smith', 'Affiliation': 'Department of Radiology and Radiological Science, Division of Cardiovascular Imaging, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Andreas M', 'Initials': 'AM', 'LastName': 'Fischer', 'Affiliation': 'Department of Radiology and Radiological Science, Division of Cardiovascular Imaging, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Akos', 'Initials': 'A', 'LastName': 'Varga-Szemes', 'Affiliation': 'Department of Radiology and Radiological Science, Division of Cardiovascular Imaging, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Vogl', 'Affiliation': 'Department of Diagnostic and Interventional Radiology, University Hospital Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Carlo N De', 'Initials': 'CN', 'LastName': 'Cecco', 'Affiliation': 'Department of Radiology and Radiological Science, Division of Cardiovascular Imaging, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'U Joseph', 'Initials': 'UJ', 'LastName': 'Schoepf', 'Affiliation': 'Department of Radiology and Radiological Science, Division of Cardiovascular Imaging, Medical University of South Carolina, Charleston, SC.'}]",AJR. American journal of roentgenology,['10.2214/AJR.20.22777']
2821,32961360,COVID-19 hits a trial: Arguments against hastily deviating from the plan.,"The COVID-19 pandemic has substantially impacted the conduct of clinical trials. While initially preparing for a period of time, where it would likely be impossible to supervise trials in the usual way and precautionary measures had to be implemented to care for medication supply and general safety of study participants it is now important to consider, how the impact of the pandemic on trial outcome can be assessed, which measures are needed to decide, how to proceed with the trial and what is needed to compensate to irregularity introduced by the pandemic situation. Obviously not all trials will suffer to the same degree: some trials may be close to finalizing recruitment, others may not yet have started. Similarly not all clinical trials investigate vulnerable patient populations, but some will and may in addition have recruited to an extent that beneficial effects achieved in the initial phase of the trial may be outweighed by an increase e.g. in mortality that impacts both treatment groups. The situation is further complicated by the fact that the pandemic reached different countries in the world and even cities in one country at different points in time with different severity. Our example is a randomized and double-blind clinical trial comparing digitoxin and placebo in patients with advanced chronic heart failure. This trial has recruited roughly 1/3 of the overall 2200 patients when the disease outbreak reached Germany. We discuss how simulations and theoretical considerations can be used to address questions about the need to increase the overall sample-size to be recruited to compensate for a potential shrinkage of the treatment effect caused by the COVID-19 pandemic and what role the degree of consistency could play when comparing pre-, during- and post- COVID-19 periods of trial conduct regarding the question, whether the treatment effect can be considered consistent and with this generalizable. This is dependent on the size of the treatment effect and the impact of the pandemic. We argue, that in case of doubt, it may be wise to proceed with the original study plan.",2020,"We discuss how simulations and theoretical considerations can be used to address questions about the need to increase the overall sample-size to be recruited to compensate for a potential shrinkage of the treatment effect caused by the COVID-19 pandemic and what role the degree of consistency could play when comparing pre-, during- and post-","['patients with advanced chronic heart failure', '2400 patients when the disease outbreak reached Germany']",['digitoxin and placebo'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C4517656', 'cui_str': '2400'}, {'cui': 'C0012652', 'cui_str': 'Disease outbreak'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0017480', 'cui_str': 'Germany'}]","[{'cui': 'C0012258', 'cui_str': 'Digitoxin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],2400.0,0.116561,"We discuss how simulations and theoretical considerations can be used to address questions about the need to increase the overall sample-size to be recruited to compensate for a potential shrinkage of the treatment effect caused by the COVID-19 pandemic and what role the degree of consistency could play when comparing pre-, during- and post-","[{'ForeName': 'Anika', 'Initials': 'A', 'LastName': 'Großhennig', 'Affiliation': 'Institut für Biometrie, Medizinische Hochschule Hannover, Germany. Electronic address: grosshennig.anika@mh-hannover.de.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Koch', 'Affiliation': 'Institut für Biometrie, Medizinische Hochschule Hannover, Germany. Electronic address: koch.armin@mh-hannover.de.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106155']
2822,32961410,Intranasal oxytocin and the stress-buffering effects of social support during experimentally induced pain: The role of attachment security.,"BACKGROUND


This study examined whether intranasal oxytocin enhances the stress-buffering effects of social support during experimentally induced pain, taking into account the role of individual differences in attachment security.
METHODS


Female participants (N = 193) were randomly assigned to oxytocin (24 IU intranasal) or placebo and to receive support or no support from a friend (2 × 2 factorial design with repeated measures)). Participants underwent the Cold Pressor Task (CPT) and were monitored for heart rate variability (HRV: RMSSD) and heart rate and reported pain levels. The Experiences in Close Relationships Questionnaire was used to measure attachment.
RESULTS


Oxytocin reduced RMSSD (p = 0.003, partial ɳ 2  = 0.03) and increased heart rate (p = 0.039, partial ɳ 2  = 0.03) in individuals who received support, possibly reflecting an enhanced attentional state. Oxytocin did not enhance beneficial effects of social support on perceived pain, but increased pain intensity in avoidantly attached individuals who were supported by a friend (p = 0.009, partial ɳ 2  = 0.06).
LIMITATIONS


Only female participants were examined. Future studies are needed to determine sex differences in how oxytocin shapes stress-buffering effects of support.
CONCLUSIONS


Oxytocin may enhance the salience of social proximity and may be a mechanism underlying previously reported social influences on cardiovascular and mental health. However, oxytocin effects depend on interpersonal insecurities and may trigger discomfort in avoidantly attached individuals. Caution about oxytocin's therapeutic promise is warranted.",2020,"Oxytocin did not enhance beneficial effects of social support on perceived pain, but increased pain intensity in avoidantly attached individuals who were supported by a friend (p = 0.009, partial ɳ 2  = 0.06).
","['Only female participants', 'Female participants (N\xa0=\xa0193']","['intranasal oxytocin', 'oxytocin', 'placebo and to receive support or no support from a friend', 'Oxytocin', 'Cold Pressor Task (CPT', 'Intranasal oxytocin']","['heart rate variability (HRV: RMSSD) and heart rate and reported pain levels', 'pain intensity', 'RMSSD', 'heart rate', 'pain']","[{'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0079382', 'cui_str': 'Friend'}, {'cui': 'C0444689', 'cui_str': 'Cold pressor test'}, {'cui': 'C0006938', 'cui_str': 'Captopril'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0010343', 'cui_str': 'Croatia'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",193.0,0.159338,"Oxytocin did not enhance beneficial effects of social support on perceived pain, but increased pain intensity in avoidantly attached individuals who were supported by a friend (p = 0.009, partial ɳ 2  = 0.06).
","[{'ForeName': 'M M E', 'Initials': 'MME', 'LastName': 'Riem', 'Affiliation': 'Behavioural Science Institute, Radboud University, The Netherlands; Department of Clinical Child and Family Studies, VU University, Amsterdam, The Netherlands. Electronic address: m.riem@psych.ru.nl.'}, {'ForeName': 'L E', 'Initials': 'LE', 'LastName': 'Kunst', 'Affiliation': 'Center of Research on Psychological and Somatic disorders, Department of Medical and Clinical Psychology, Tilburg University, Tilburg, The Netherlands; Mentaal Beter, Breda, The Netherlands. Electronic address: L.E.Kunst@tilburguniversity.edu.'}, {'ForeName': 'W J', 'Initials': 'WJ', 'LastName': 'Kop', 'Affiliation': 'Center of Research on Psychological and Somatic disorders, Department of Medical and Clinical Psychology, Tilburg University, Tilburg, The Netherlands. Electronic address: W.J.Kop@tilburguniversity.edu.'}]",Journal of affective disorders,['10.1016/j.jad.2020.09.057']
2823,32961445,"Patient-reported outcomes with first-line durvalumab plus platinum-etoposide versus platinum-etoposide in extensive-stage small-cell lung cancer (CASPIAN): a randomized, controlled, open-label, phase III study.","OBJECTIVES


In the phase III CASPIAN study, first-line durvalumab plus etoposide in combination with either cisplatin or carboplatin (EP) significantly improved overall survival (primary endpoint) versus EP alone in patients with extensive-stage small-cell lung cancer (ES-SCLC) at the interim analysis. Here we report patient-reported outcomes (PROs).
MATERIALS AND METHODS


Treatment-naïve patients with ES-SCLC received 4 cycles of durvalumab plus EP every 3 weeks followed by maintenance durvalumab every 4 weeks until progression, or up to 6 cycles of EP every 3 weeks. PROs, assessed with the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) version 3 and its lung cancer module, the Quality of Life Questionnaire-Lung Cancer 13 (QLQ-LC13), were prespecified secondary endpoints. Changes from baseline to disease progression or 12 months in prespecified key disease-related symptoms (cough, dyspnea, chest pain, fatigue, appetite loss) were analyzed with a mixed model for repeated measures. Time to deterioration (TTD) of symptoms, functioning, and global health status/quality of life (QoL) from randomization was analyzed.
RESULTS


In the durvalumab plus EP and EP arms, 261 and 260 patients were PRO-evaluable. Patients in both arms experienced numerically reduced symptom burden over 12 months or until progression for key symptoms. For the improvements from baseline in appetite loss, the between-arm difference was statistically significant, favoring durvalumab plus EP (difference, -4.5; 99% CI: -9.04, -0.04; nominal p = 0.009). Patients experienced longer TTD with durvalumab plus EP versus EP for all symptoms (hazard ratio [95% CI] for key symptoms: cough 0.78 [0.600‒1.026]; dyspnea 0.79 [0.625‒1.006]; chest pain 0.76 [0.575‒0.996]; fatigue 0.82 [0.653‒1.027]; appetite loss 0.70 [0.542‒0.899]), functioning, and global health status/QoL.
CONCLUSION


Addition of durvalumab to first-line EP maintained QoL and delayed worsening of patient-reported symptoms, functioning, and global health status/QoL compared with EP.",2020,"For the improvements from baseline in appetite loss, the between-arm difference was statistically significant, favoring durvalumab plus EP (difference, -4.5; 99% CI: -9.04, -0.04; nominal p = 0.009).","['Treatment-naïve patients with ES-SCLC received 4 cycles of', 'patients with extensive-stage small-cell lung cancer (ES-SCLC', 'extensive-stage small-cell lung cancer (CASPIAN']","['first-line durvalumab plus platinum-etoposide versus platinum-etoposide', 'cisplatin or carboplatin (EP', 'EP alone', 'durvalumab plus EP']","['appetite loss 0.70 [0.542‒0.899]), functioning, and global health status/QoL.\nCONCLUSION\n\n\nAddition of durvalumab to first-line EP maintained QoL and delayed worsening of patient-reported symptoms, functioning, and global health status/QoL', 'Quality of Life Questionnaire-Core 30 (QLQ-C30) version 3 and its lung cancer module, the Quality of Life Questionnaire-Lung Cancer 13 (QLQ-LC13', 'Cancer (EORTC', 'appetite loss', 'chest pain 0.76', 'symptom burden', 'symptoms (cough, dyspnea, chest pain, fatigue, appetite loss', 'overall survival', 'Time to deterioration (TTD) of symptoms, functioning, and global health status/quality of life (QoL']","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278726', 'cui_str': 'Small cell lung cancer extensive stage'}]","[{'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C4055109', 'cui_str': 'durvalumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}]","[{'cui': 'C0003123', 'cui_str': 'Anorexia'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4055109', 'cui_str': 'durvalumab'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008031', 'cui_str': 'Chest pain'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.142705,"For the improvements from baseline in appetite loss, the between-arm difference was statistically significant, favoring durvalumab plus EP (difference, -4.5; 99% CI: -9.04, -0.04; nominal p = 0.009).","[{'ForeName': 'Jonathan W', 'Initials': 'JW', 'LastName': 'Goldman', 'Affiliation': 'David Geffen School of Medicine at UCLA, Los Angeles, CA, USA. Electronic address: jwgoldman@mednet.ucla.edu.'}, {'ForeName': 'Marina Chiara', 'Initials': 'MC', 'LastName': 'Garassino', 'Affiliation': 'Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Yuanbin', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Cancer & Hematology Centers of Western Michigan, Grand Rapids, MI, USA.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Özgüroğlu', 'Affiliation': 'Istanbul University-Cerrahpaşa, Cerrahpaşa School of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Mikhail', 'Initials': 'M', 'LastName': 'Dvorkin', 'Affiliation': 'BHI of Omsk Region Clinical Oncology Dispensary, Omsk, Russia.'}, {'ForeName': 'Dmytro', 'Initials': 'D', 'LastName': 'Trukhin', 'Affiliation': 'Odessa National Medical University, Odessa, Ukraine.'}, {'ForeName': 'Galina', 'Initials': 'G', 'LastName': 'Statsenko', 'Affiliation': 'Omsk Regional Cancer Center, Omsk, Russian Federation.'}, {'ForeName': 'Katsuyuki', 'Initials': 'K', 'LastName': 'Hotta', 'Affiliation': 'Okayama University Hospital, Okayama, Japan.'}, {'ForeName': 'Jun Ho', 'Initials': 'JH', 'LastName': 'Ji', 'Affiliation': 'Samsung Changwon Hospital, Sungkyunkwan University School of Medicine, Changwon, Republic of Korea.'}, {'ForeName': 'Maximilian J', 'Initials': 'MJ', 'LastName': 'Hochmair', 'Affiliation': 'Karl Landsteiner Institute of Lung Research and Pulmonary Oncology, Klinik Floridsdorf, Vienna, Austria.'}, {'ForeName': 'Oleksandr', 'Initials': 'O', 'LastName': 'Voitko', 'Affiliation': 'Kyiv City Clinical Oncological Centre, Kiev, Ukraine.'}, {'ForeName': 'Libor', 'Initials': 'L', 'LastName': 'Havel', 'Affiliation': 'Thomayer Hospital, First Faculty of Medicine, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Artem', 'Initials': 'A', 'LastName': 'Poltoratskiy', 'Affiliation': 'Petrov Research Institute of Oncology, St Petersburg, Russian Federation.'}, {'ForeName': 'György', 'Initials': 'G', 'LastName': 'Losonczy', 'Affiliation': 'Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Reinmuth', 'Affiliation': 'Asklepios Lung Clinic, Munich-Gauting, Germany.'}, {'ForeName': 'Nikunj', 'Initials': 'N', 'LastName': 'Patel', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Laud', 'Affiliation': 'Statistical Services Unit, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Norah', 'Initials': 'N', 'LastName': 'Shire', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Haiyi', 'Initials': 'H', 'LastName': 'Jiang', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Paz-Ares', 'Affiliation': 'Hospital Universitario 12 de Octubre, H120-CNIO Lung Cancer Unit, Universidad Complutense and Ciberonc, Madrid, Spain.'}]","Lung cancer (Amsterdam, Netherlands)",['10.1016/j.lungcan.2020.09.003']
2824,32961500,One-day Acceptance and Commitment Therapy workshop for preventing persistent post-surgical pain and dysfunction in at-risk veterans: A randomized controlled trial protocol.,"OBJECTIVE


Persistent post-surgical pain is common among patients undergoing surgery, is detrimental to patients' quality of life, and can precipitate long-term opioid use. The purpose of this randomized controlled trial is to assess the effects of a behavioral intervention offered prior to surgery for patients at risk for poor post-surgical outcomes, including persistent pain and impaired functioning.
METHODS


Described herein is an ongoing randomized, patient- and assessor-blind, attention-controlled multisite clinical trial. Four hundred and thirty Veterans indicated for total knee arthroplasty (TKA) with distress and/or pain will be recruited for this study. Participants will be randomly assigned to a one-day (~5 h) Acceptance and Commitment Therapy workshop or one-day education and attention control workshop. Approximately two weeks following their TKA surgery, patients receive an individualized booster session via phone. Following their TKA, patients complete assessments at 1 week, 6 weeks, 3 months, and 6 months.
RESULTS


The primary outcomes are pain intensity and knee-specific functioning; secondary outcomes are symptoms of distress and coping skills. Mediation analyses will examine whether changes in symptoms of distress and coping skills have an impact on pain and functioning at 6 months in Veterans receiving ACT. This study is conducted mostly with older Veterans; therefore, results may not generalize to women and younger adults who are underrepresented in this veteran population.
CONCLUSIONS


The results of this study will provide the first evidence from a large-scale, patient- and assessor-blind controlled trial on the effectiveness of a brief behavioral intervention for the prevention of persistent post-surgical pain and dysfunction.",2020,Mediation analyses will examine whether changes in symptoms of distress and coping skills have an impact on pain and functioning at 6 months in Veterans receiving ACT.,"['patients undergoing surgery', 'older Veterans', 'patients at risk for poor post-surgical outcomes, including persistent pain and impaired functioning', 'Four hundred and thirty Veterans', 'at-risk veterans', 'women and younger adults who are underrepresented in this veteran population']","['Acceptance and Commitment Therapy workshop or one-day education and attention control workshop', 'behavioral intervention']","['pain intensity and knee-specific functioning; secondary outcomes are symptoms of distress and coping skills', 'total knee arthroplasty (TKA) with distress and/or pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C3658321', 'cui_str': 'Acceptance and commitment therapy'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0086059', 'cui_str': 'Coping Skills'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",430.0,0.299537,Mediation analyses will examine whether changes in symptoms of distress and coping skills have an impact on pain and functioning at 6 months in Veterans receiving ACT.,"[{'ForeName': 'McKenzie K', 'Initials': 'MK', 'LastName': 'Roddy', 'Affiliation': 'Menninger Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, Houston, TX, United States of America.'}, {'ForeName': 'Derrecka M', 'Initials': 'DM', 'LastName': 'Boykin', 'Affiliation': 'South Central Mental Illness, Research and Clinical Center, Michael E. DeBakey VA Medical Center, Houston, TX, United States of America.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Hadlandsmyth', 'Affiliation': 'Department of Anesthesia, Carver College of Medicine, University of Iowa, Iowa City, IA, United States of America.'}, {'ForeName': 'James N', 'Initials': 'JN', 'LastName': 'Marchman', 'Affiliation': 'Department of Psychology, University of Iowa, Iowa City, IA, United States of America.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Green', 'Affiliation': 'Michael E. DeBakey Veteran Affairs Medical Center, Houston, TX, United States of America.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Buckwalter', 'Affiliation': 'Department of Orthopedics and Rehabilitation, Carver College of Medicine, University of Iowa, United States of America.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Garvin', 'Affiliation': 'Department of Psychiatry, University of Iowa Hospitals and Clinics, Iowa City, IA, United States of America.'}, {'ForeName': 'Bridget', 'Initials': 'B', 'LastName': 'Zimmerman', 'Affiliation': 'College of Public Health, University of Iowa, Iowa City, IA, United States of America.'}, {'ForeName': 'Jaewon', 'Initials': 'J', 'LastName': 'Bae', 'Affiliation': 'College of Nursing, University of Iowa, Iowa City, IA, United States of America.'}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Cortesi', 'Affiliation': 'College of Nursing, University of Iowa, Iowa City, IA, United States of America.'}, {'ForeName': 'Merlyn', 'Initials': 'M', 'LastName': 'Rodrigues', 'Affiliation': 'Department of Medicine, Baylor College of Medicine, Houston, TX, United States of America.'}, {'ForeName': 'Jennie', 'Initials': 'J', 'LastName': 'Embree', 'Affiliation': 'College of Nursing, University of Iowa, Iowa City, IA, United States of America.'}, {'ForeName': 'Barbara A', 'Initials': 'BA', 'LastName': 'Rakel', 'Affiliation': 'College of Nursing, University of Iowa, Iowa City, IA, United States of America. Electronic address: barbara-rakel@uiowa.edu.'}, {'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Dindo', 'Affiliation': 'Department of Medicine, Baylor College of Medicine, Houston, TX, United States of America; Houston VA HSR&D Center for Innovations in Quality, Effectiveness and Safety, Michael E. DeBakey Veterans Affairs Medical Center, Houston, TX, United States of America. Electronic address: lilian.dindo@bcm.edu.'}]",Journal of psychosomatic research,['10.1016/j.jpsychores.2020.110250']
2825,32962422,The Effect of Transcranial Pulsed Current Stimulation at 4 and 75 Hz on Electroencephalography Theta and High Gamma Band Power: A Pilot Study.,"Introduction:  Transcranial pulsed current stimulation (tPCS) is an emerging noninvasive brain stimulation technique that has shown significant effects on cortical excitability. To date, electrophysiological measures of the efficiency of monophasic tPCS have not been reported.  Objective:  We aimed to explore the effects of monophasic anodal and cathodal-tPCS (a-tPCS/c-tPCS) at theta (4 Hz) and gamma (75 Hz) frequencies on theta and high gamma electroencephalography (EEG) oscillatory power.  Methods:  In a single-blind, randomized, sham-controlled crossover design, 15 healthy participants were randomly assigned into 5 experimental sessions in which they received a-PCS/c-tPCS at 4 and 75 Hz or sham stimulation over the left primary motor cortex (M1) for 15 min at an intensity of 1.5 mA. Changes in theta and high gamma oscillatory power were recorded at baseline, immediately after, and 30 min after stimulation using EEG at rest with eyes open.  Results:  a-tPCS at 4 Hz showed a significant increase in theta power compared with sham, whereas c-tPCS at 4 Hz had no significant effect on theta power. a-tPCS at 75 Hz produced no changes in high gamma power compared with sham. Importantly, c-tPCS at 75 Hz led to a significant reduction in high gamma power compared with baseline, as well as compared with c-tPCS at 4 Hz and sham stimulation.  Conclusion:  The results demonstrate the modulation of oscillatory brain activity by monophasic tPCS, and highlight the need for future studies on a larger scale to confirm these initial findings. Impact statement Transcranial pulsed current stimulation (tPCS) is a novel brain stimulation technique. Recently, tPCS has been introduced to directly modulate brain oscillations by applying pulsatile current over the target brain area. Using both anodal and cathodal monophasic tPCS at theta and gamma frequencies, we demonstrate the ability of the stimulation to modulate brain activity. The present findings are the first direct electroencephalography evidence of an interaction between tPCS and ongoing oscillatory activity in the human motor cortex. Our work recommends tPCS as a tool for investigating human brain oscillations and open more studies in this area.",2020,"A-tPCS at 4 Hz showed a significant increase in theta power compared to sham, whereas c-tPCS at 4 Hz had no significant effect on theta power.",['15 healthy participants'],"['Transcranial pulsed current stimulation (tPCS', 'PCS/c-tPCS at 4 and 75 Hz or sham stimulation over the left primary motor cortex (M1', 'transcranial pulsed current stimulation at 4 and 75 Hz on EEG theta and high gamma band power', 'monophasic anodal and cathodal-tPCS (a-tPCS/c-tPCS) at theta (4 Hz) and gamma (75 Hz) frequencies on theta and high gamma electroencephalography (EEG) oscillatory power']",['theta power'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0442348', 'cui_str': 'Transcranial approach'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C1882368', 'cui_str': 'Dynamic Light Scattering'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C3495441', 'cui_str': 'Precentral Motor Cortex'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0017011', 'cui_str': 'Gamma radiation'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C0205186', 'cui_str': 'Monophasic'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]","[{'cui': 'C0439101', 'cui_str': 'Theta'}]",15.0,0.0508888,"A-tPCS at 4 Hz showed a significant increase in theta power compared to sham, whereas c-tPCS at 4 Hz had no significant effect on theta power.","[{'ForeName': 'Thusharika', 'Initials': 'T', 'LastName': 'Dissanayaka', 'Affiliation': 'Non-invasive Brain Stimulation & Neuroplasticity Laboratory, Department of Physiotherapy, School of Primary and Allied Health Care, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Zoghi', 'Affiliation': 'Department of Rehabilitation, Nutrition and Sport, School of Allied Health, La Trobe University, Melbourne, Australia.'}, {'ForeName': 'Aron T', 'Initials': 'AT', 'LastName': 'Hill', 'Affiliation': 'Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Farrell', 'Affiliation': 'Monash Biomedical Imaging, Monash University, Melbourne, Australia.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Egan', 'Affiliation': 'Monash Biomedical Imaging, Monash University, Melbourne, Australia.'}, {'ForeName': 'Shapour', 'Initials': 'S', 'LastName': 'Jaberzadeh', 'Affiliation': 'Non-invasive Brain Stimulation & Neuroplasticity Laboratory, Department of Physiotherapy, School of Primary and Allied Health Care, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia.'}]",Brain connectivity,['10.1089/brain.2020.0756']
2826,32942053,Mindfulness-based stress reduction for HIV-associated neurocognitive disorder: Rationale and protocol for a randomized controlled trial in older adults.,"The symptom burden of HIV-associated neurocognitive disorder (HAND) is high among older individuals, and treatment options are limited. Mindfulness-based stress reduction (MBSR) has potential to improve neurocognitive performance, psychosocial wellbeing, and quality of life, but empirical studies in this growing vulnerable population are lacking. In this trial, participants (N = 180) age 55 and older who are living with HIV infection, are on combination antiretroviral therapy with suppressed viral loads, and yet continue to experience behavioral and cognitive symptoms of HAND, are randomized to MBSR or to a waitlist control arm that receives MBSR following a 16-week period of standard care. Primary outcomes (attention, executive function, stress, anxiety, depression, everyday functioning, quality of life) and potential mediators (affect, mindfulness) and moderators (social support, loneliness) are assessed at baseline and weeks 8, 16, and 48 in both groups, with an additional assessment at week 24 (post-MBSR) in the crossover control group. Assessments include self-report and objective measures (e.g., neuropsychological assessment, neurological exam, clinical labs). In addition, a subset of participants (n = 30 per group) are randomly selected to undergo fMRI to evaluate changes in functional connectivity networks and their relationship to changes in neuropsychological outcomes. Forthcoming findings from this randomized controlled trial have the potential to contribute to a growing public health need as the number of older adults with HAND is expected to rise.",2020,"Mindfulness-based stress reduction (MBSR) has potential to improve neurocognitive performance, psychosocial wellbeing, and quality of life, but empirical studies in this growing vulnerable population are lacking.","['older adults', 'HIV-associated neurocognitive disorder', 'participants (N\u202f=\u202f180) age 55 and older who are living with HIV infection, are on combination antiretroviral therapy with suppressed viral loads, and yet continue to experience behavioral and cognitive symptoms of HAND']","['Mindfulness-based stress reduction (MBSR', 'Mindfulness-based stress reduction']","['neurocognitive performance, psychosocial wellbeing, and quality of life', 'symptom burden of HIV-associated neurocognitive disorder (HAND', 'Primary outcomes (attention, executive function, stress, anxiety, depression, everyday functioning, quality of life) and potential mediators (affect, mindfulness) and moderators (social support, loneliness', 'Assessments include self-report and objective measures (e.g., neuropsychological assessment, neurological exam, clinical labs']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C4041080', 'cui_str': 'Neurocognitive disorder'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019693', 'cui_str': 'Human immunodeficiency virus infection'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C1260953', 'cui_str': 'Suppressed'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0525041', 'cui_str': 'Cognitive Symptoms'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C4041080', 'cui_str': 'Neurocognitive disorder'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0027853', 'cui_str': 'Neurological examination'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}]",180.0,0.0447385,"Mindfulness-based stress reduction (MBSR) has potential to improve neurocognitive performance, psychosocial wellbeing, and quality of life, but empirical studies in this growing vulnerable population are lacking.","[{'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Addington', 'Affiliation': 'Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL, USA; Osher Center for Integrative Medicine, Northwestern University, Chicago, IL, USA. Electronic address: elizabeth.addington@northwestern.edu.'}, {'ForeName': 'Shireen', 'Initials': 'S', 'LastName': 'Javandel', 'Affiliation': 'Memory and Aging Center, Department of Neurology, University of California, San Francisco, California, USA.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'De Gruttola', 'Affiliation': 'Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Paul', 'Affiliation': 'Missouri Institute of Mental Health, University of Missouri-St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Benedetta', 'Initials': 'B', 'LastName': 'Milanini', 'Affiliation': 'Memory and Aging Center, Department of Neurology, University of California, San Francisco, California, USA.'}, {'ForeName': 'Beau M', 'Initials': 'BM', 'LastName': 'Ances', 'Affiliation': 'Department of Neurology, Washington University in St. Louis, School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Judith T', 'Initials': 'JT', 'LastName': 'Moskowitz', 'Affiliation': 'Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL, USA; Osher Center for Integrative Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Valcour', 'Affiliation': 'Memory and Aging Center, Department of Neurology, University of California, San Francisco, California, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106150']
2827,32942054,Design and baseline data of a randomized trial comparing two methods for scaling-up an occupational sun protection intervention.,"BACKGROUND


Successful methods for scaling-up evidence-based programs are needed to prevent skin cancer among adults who work outdoors in the sun.
METHODS


A randomized trial is being conducted comparing two methods of scaling-up the Sun Safe Workplaces (SSW) intervention. Departments of transportation (DOTs) from 21 U.S. states are participating and their 138 regional districts were randomized following baseline assessment. In districts assigned to the in-person method (n = 46), project staff meets personally with managers, conducts trainings for employees, and provides printed materials. In districts assigned to the digital method (n = 92), project staff conduct these same activities virtually, using conferencing technology, online training, and electronic materials. Delivery of SSW in both groups was tailored to managers' readiness to adopt occupational sun safety. Posttesting will assess manager's support for and use of SSW and employees' sun safety. An economic evaluation will explore whether the method that uses digital technology results in lower implementation of SSW but is more cost-effective relative to the in-person method.
RESULTS


The state DOTs range in size from 997 to 18,415 employees. At baseline, 1113 managers (49.0%) completed the pretest (91.5% male, 91.1% white, 19.77 years on the job, 66.5% worked outdoors; and 24.4% had high-risk skin types). They were generally supportive of occupational sun safety. A minority reported that the employer had a written policy, half reported training, and two-thirds, messaging on sun protection.
CONCLUSIONS


Digital methods are available that may make scale-up of SSW cost-effective in a national distribution to nearly half of the state DOTs.
TRIAL REGISTRATION


The ClinicalTrials.gov registration number is NCT03278340.",2020,"An economic evaluation will explore whether the method that uses digital technology results in lower implementation of SSW but is more cost-effective relative to the in-person method.
","['Departments of transportation (DOTs) from 21\u202fU.S. states are participating and their 138 regional districts', 'adults who work outdoors in the sun']","['scaling-up the Sun Safe Workplaces (SSW) intervention', 'scaling-up an occupational sun protection intervention']",[],"[{'cui': 'C0040756', 'cui_str': 'Transportation'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0038817', 'cui_str': 'Sunlight'}]","[{'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0038817', 'cui_str': 'Sunlight'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0521127', 'cui_str': 'Occupational'}]",[],,0.139656,"An economic evaluation will explore whether the method that uses digital technology results in lower implementation of SSW but is more cost-effective relative to the in-person method.
","[{'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Buller', 'Affiliation': 'Research at Klein Buendel, Inc, A Health Communication and Media Development Firm, Golden, CO, USA. Electronic address: dbuller@kleinbuendel.com.'}, {'ForeName': 'Mary Klein', 'Initials': 'MK', 'LastName': 'Buller', 'Affiliation': 'President at Klein Buendel, Inc, Golden, CO, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Meenan', 'Affiliation': 'Investigator at Kaiser Permanente Center for Health Research, Portland, OR, USA.'}, {'ForeName': 'Gary R', 'Initials': 'GR', 'LastName': 'Cutter', 'Affiliation': 'Emeritus at the University of Alabama, Birmingham, AL, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Berteletti', 'Affiliation': 'Research Program Manager at Klein Buendel, Inc, Golden, CO, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Eye', 'Affiliation': 'Project Coordinator at Klein Buendel, Inc, Golden, CO, USA.'}, {'ForeName': 'Barbara J', 'Initials': 'BJ', 'LastName': 'Walkosz', 'Affiliation': 'Klein Buendel, Inc, Golden, CO, USA.'}, {'ForeName': 'Sherry', 'Initials': 'S', 'LastName': 'Pagoto', 'Affiliation': 'University of Connecticut, Storrs, CT, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106147']
2828,32949374,Pembrolizumab plus lenalidomide and dexamethasone in treatment-naive multiple myeloma (KEYNOTE-185): subgroup analysis in Japanese patients.,"The global, randomized, open-label KEYNOTE-185 study closed early after an interim analysis showed an unfavorable benefit-risk profile with pembrolizumab plus lenalidomide and low-dose dexamethasone (Rd) versus Rd alone in treatment-naive, transplant-ineligible multiple myeloma. This subgroup analysis reported outcomes in the Japanese population. Patients were randomly assigned (1:1) to pembrolizumab plus Rd or Rd alone, stratified by age and International Staging System. The primary end point was progression-free survival (PFS). Fifty-two Japanese patients were randomly assigned to pembrolizumab plus Rd (n = 27) or Rd (n = 25). The median follow-up was 7.2 months (range, 0.4-13.8). The median PFS was not reached (NR); 6-month PFS was 91.2% versus 86.2% with pembrolizumab plus Rd versus Rd [hazard ratio (HR), 0.31; 95% CI, 0.06-1.63]. The median overall survival (OS) was NR; 6-month OS was 96.2% versus 95.7% with pembrolizumab plus Rd versus Rd (HR, 0.33; 95% CI, 0.03-3.72). With pembrolizumab plus Rd versus Rd, grade 3-5 adverse events occurred in 70.4% versus 69.6% of patients; serious adverse events occurred in 40.7% versus 52.5%. Although in the Japanese subgroup of KEYNOTE-185 adding pembrolizumab to Rd did not show an unfavorable risk-benefit, the analysis is limited by short follow-up and small sample size, affecting generalizability of the results.",2020,"The median PFS was not reached (NR); 6-month PFS was 91.2% versus 86.2% with pembrolizumab plus Rd versus Rd [hazard ratio (HR), 0.31; 95% CI, 0.06-1.63].","['treatment-naive, transplant-ineligible multiple myeloma', 'Fifty-two Japanese patients', 'Japanese patients']","['pembrolizumab plus Rd or Rd alone, stratified by age and International Staging System', 'pembrolizumab plus Rd', 'Pembrolizumab plus lenalidomide and dexamethasone', 'pembrolizumab plus lenalidomide and low-dose dexamethasone (Rd) versus Rd alone']","['adverse events', 'median overall survival (OS', '6-month OS', 'progression-free survival (PFS', 'median PFS']","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C4319570', 'cui_str': '52'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0449394', 'cui_str': 'Staging system'}, {'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",52.0,0.111537,"The median PFS was not reached (NR); 6-month PFS was 91.2% versus 86.2% with pembrolizumab plus Rd versus Rd [hazard ratio (HR), 0.31; 95% CI, 0.06-1.63].","[{'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Takezako', 'Affiliation': 'National Hospital Organization Disaster Medical Center, 3256 Midori, Tachikawa, Tokyo, Japan. ntakezak@gmail.com.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Kosugi', 'Affiliation': 'Ogaki Municipal Hospital, Ogaki, Japan.'}, {'ForeName': 'Morio', 'Initials': 'M', 'LastName': 'Matsumoto', 'Affiliation': 'National Hospital Organization, Shibukawa Medical Center, Shibukawa, Japan.'}, {'ForeName': 'Shinsuke', 'Initials': 'S', 'LastName': 'Iida', 'Affiliation': 'Nagoya City University Hospital, Nagoya, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Ishikawa', 'Affiliation': 'Kobe City Medical Center, Kobe, Japan.'}, {'ForeName': 'Yukio', 'Initials': 'Y', 'LastName': 'Kondo', 'Affiliation': 'Kanazawa University Hospital, Kanazawa, Japan.'}, {'ForeName': 'Kiyoshi', 'Initials': 'K', 'LastName': 'Ando', 'Affiliation': 'Tokai University School of Medicine, Isehara, Japan.'}, {'ForeName': 'Hirokazu', 'Initials': 'H', 'LastName': 'Miki', 'Affiliation': 'Tokushima University Hospital, Tokushima, Japan.'}, {'ForeName': 'Itaru', 'Initials': 'I', 'LastName': 'Matsumura', 'Affiliation': 'Kindai University Hospital, Osaka-Sayama, Japan.'}, {'ForeName': 'Kazutaka', 'Initials': 'K', 'LastName': 'Sunami', 'Affiliation': 'National Hospital Organization Okayama Medical Center, Okayama, Japan.'}, {'ForeName': 'Takanori', 'Initials': 'T', 'LastName': 'Teshima', 'Affiliation': 'Hokkaido University Hospital, Sapporo, Japan.'}, {'ForeName': 'Hiromi', 'Initials': 'H', 'LastName': 'Iwasaki', 'Affiliation': 'National Hospital Organization Kyushu Medical Center, Fukuoka, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Onishi', 'Affiliation': 'Tohoku University Hospital, Sendai, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Kizaki', 'Affiliation': 'Saitama Medical Center, Saitama Medical University, Kawagoe-shi, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Izutsu', 'Affiliation': 'National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Dai', 'Initials': 'D', 'LastName': 'Maruyama', 'Affiliation': 'National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Kensei', 'Initials': 'K', 'LastName': 'Tobinai', 'Affiliation': 'National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Razi', 'Initials': 'R', 'LastName': 'Ghori', 'Affiliation': 'Merck & Co., Inc., Kentilworth, NJ, USA.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Farooqui', 'Affiliation': 'Merck & Co., Inc., Kentilworth, NJ, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Liao', 'Affiliation': 'Merck & Co., Inc., Kentilworth, NJ, USA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Marinello', 'Affiliation': 'Merck & Co., Inc., Kentilworth, NJ, USA.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Matsuda', 'Affiliation': 'MSD K.K, Tokyo, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Koh', 'Affiliation': 'MSD K.K, Tokyo, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Shimamoto', 'Affiliation': 'MSD K.K, Tokyo, Japan.'}, {'ForeName': 'Kenshi', 'Initials': 'K', 'LastName': 'Suzuki', 'Affiliation': 'Japanese Red Cross Medical Center, Tokyo, Japan.'}]",International journal of hematology,['10.1007/s12185-020-02953-3']
2829,32946551,Do home modifications reduce care home admissions for older people? A matched control evaluation of the Care & Repair Cymru service in Wales.,"BACKGROUND


home advice and modification interventions aim to promote independent living for those living in the community, but quantitative evidence of their effectiveness is limited.
AIM


assess the risk of care home admissions for people with different frailty levels receiving home advice and modification interventions against a control group who do not.
STUDY DESIGN AND SETTING


matched control evaluation using linked longitudinal data from the Secure Anonymised Information Linkage (SAIL) Databank, comprising people aged 60-95, registered with a SAIL contributing general practice. The intervention group received the Care & Repair Cymru (C & RC) service, a home advice and modification service available to residents in Wales.
METHODS


frailty, age and gender were used in propensity score matching to assess the Hazard Ratio (HR) of care home admissions within a 1-, 3- and 5-year period for the intervention group (N = 93,863) compared to a matched control group (N = 93,863). Kaplan-Meier curves were used to investigate time to a care home admission.
RESULTS


the intervention group had an increased risk of a care home admission at 1-, 3- and 5-years [HR (95%CI)] for those classified as fit [1-year: 2.02 (1.73, 2.36), 3-years: 1.87 (1.72, 2.04), 5-years: 1.99 (1.86, 2.13)] and mildly frail [1-year: 1.25 (1.09, 1.42), 3-years: 1.25 (1.17, 1.34), 5-years: 1.30 (1.23, 1.38)], but a reduced risk of care home admission for moderately [1-year: 0.66 (0.58, 0.75), 3-years: 0.75 (0.70, 0.80), 5-years: 0.83 (0.78, 0.88)] and severely frail individuals [1-year: 0.44 (0.37, 0.54), 3-years: 0.54 (0.49, 0.60), 5-years: 0.60(0.55, 0.66)].
CONCLUSIONS


HRs indicated that the C & RC service helped to prevent care home admissions for moderately and severely frail individuals. The HRs generally increased with follow-up duration.",2020,"the intervention group had an increased risk of a care home admission at 1-, 3- and 5-years","['people with different frailty levels receiving home advice and modification interventions against a control group who do not', '5-years', 'matched control evaluation using linked longitudinal data from the Secure Anonymised Information Linkage (SAIL) Databank, comprising people aged 60-95, registered with a SAIL contributing general practice']","['C & RC service', 'Care & Repair Cymru (C & RC) service, a home advice and modification service available to residents in Wales']","['reduced risk of care home admission', 'risk of a care home admission', 'Hazard Ratio (HR) of care home admissions', 'mildly frail', 'HR (95%CI']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}]","[{'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0043015', 'cui_str': 'Wales'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C2945599', 'cui_str': 'Mild'}, {'cui': 'C0079377', 'cui_str': 'Frail elderly'}]",,0.0910446,"the intervention group had an increased risk of a care home admission at 1-, 3- and 5-years","[{'ForeName': 'Joe', 'Initials': 'J', 'LastName': 'Hollinghurst', 'Affiliation': 'Swansea University, Swansea, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Fry', 'Affiliation': 'Swansea University, Swansea, UK.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Akbari', 'Affiliation': 'Swansea University, Swansea, UK.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Watkins', 'Affiliation': 'Swansea University, Swansea, UK.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Williams', 'Affiliation': 'Care & Repair Cymru, Cardiff, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Hillcoat-Nallétamby', 'Affiliation': 'Swansea University, Swansea, UK.'}, {'ForeName': 'Ronan A', 'Initials': 'RA', 'LastName': 'Lyons', 'Affiliation': 'Swansea University, Swansea, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Clegg', 'Affiliation': 'University of Leeds, Leeds, UK.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Rodgers', 'Affiliation': 'University of Liverpool, Liverpool, UK.'}]",Age and ageing,['10.1093/ageing/afaa158']
2830,32948045,Comparison of the Effects of Visual and Auditory Distractions on Fistula Cannulation Pain among Older Patients Undergoing Hemodialysis: A Randomized Controlled Clinical Trial.,"Pain associated with fistula cannulation is a challenge for nurses who provide care to older patients undergoing hemodialysis. Several non-pharmacological methods have been suggested for relieving fistula cannulation pain, but the benefits of visual and auditory distraction methods among older patients undergoing hemodialysis have not been investigated yet. Therefore, this study aimed to compare the effects of visual and auditory distractions on fistula cannulation pain among older patients undergoing hemodialysis. This randomized controlled clinical trial was conducted on 120 older patients undergoing hemodialysis. They were randomly assigned to three groups of visual distraction, auditory distraction, and the control ( n  = 40 in each group) using a simple random assignment method. The distraction interventions continued for three consecutive sessions and the numeric rating scale of pain severity was used for data collection. Descriptive and inferential statistics were used for data analysis using SPSS. It was found that pain severity significantly reduced after the distraction interventions in either the auditory or visual distraction groups and also after all three distraction sessions ( p  = 0.001). However, visual distraction had a better effect on the reduction of pain severity. Therefore, while both visual and auditory distractions reduced pain severity in older patients undergoing hemodialysis, visual distraction was more effective. Nurses are encouraged to incorporate visual distraction as a safe and non-pharmacologic technique into routine nursing care for reducing older patients' suffering and improving their wellbeing when fistula cannulation is performed.",2020,It was found that pain severity significantly reduced after the distraction interventions in either the auditory or visual distraction groups and also after all three distraction sessions ( p  = 0.001).,"['Older Patients Undergoing Hemodialysis', 'older patients undergoing hemodialysis', 'older patients undergoing', '120 older patients undergoing hemodialysis']","['Visual and Auditory Distractions', 'hemodialysis, visual distraction', 'fistula cannulation', 'visual and auditory distractions', 'visual distraction, auditory distraction, and the control']","['fistula cannulation pain', 'Fistula Cannulation Pain', 'Pain', 'numeric rating scale of pain severity', 'pain severity']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C4319550', 'cui_str': '120'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0150189', 'cui_str': 'Distraction training'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",120.0,0.0398348,It was found that pain severity significantly reduced after the distraction interventions in either the auditory or visual distraction groups and also after all three distraction sessions ( p  = 0.001).,"[{'ForeName': 'Mina Ghadimi', 'Initials': 'MG', 'LastName': 'Aghbolagh', 'Affiliation': 'Department of Nursing, Faculty of Nursing and Midwifery, Shahed University, Tehran 3319118651, Iran.'}, {'ForeName': 'Tahereh', 'Initials': 'T', 'LastName': 'Bahrami', 'Affiliation': 'Department of Nursing, Faculty of Nursing and Midwifery, Shahed University, Tehran 3319118651, Iran.'}, {'ForeName': 'Nahid', 'Initials': 'N', 'LastName': 'Rejeh', 'Affiliation': 'Department of Nursing, Faculty of Nursing and Midwifery, Shahed University, Tehran 3319118651, Iran.'}, {'ForeName': 'Majideh', 'Initials': 'M', 'LastName': 'Heravi-Karimooi', 'Affiliation': 'Department of Nursing, Faculty of Nursing and Midwifery, Shahed University, Tehran 3319118651, Iran.'}, {'ForeName': 'Seyed Davood', 'Initials': 'SD', 'LastName': 'Tadrisi', 'Affiliation': 'Trauma Research Center, Faculty of Nursing, Baqiyatallah University of Medical Sciences, Tehran 1435916471, Iran.'}, {'ForeName': 'Mojtaba', 'Initials': 'M', 'LastName': 'Vaismoradi', 'Affiliation': 'Faculty of Nursing and Health Sciences, Nord University, 8049 Bodø, Norway.'}]","Geriatrics (Basel, Switzerland)",['10.3390/geriatrics5030053']
2831,32948108,Analogy and explicit motor learning in dynamic balance: Posturography and performance analyses.,"Unlike explicit learning, analogy learning allows learners to acquire skills with a movement metaphor with fewer verbal knowledge accumulated during early learning, resulting in less reliance on cognitive resources for better motor performances. However, the efficacy of analogical instruction on balance is still unclear. This study examined learning and subsequent performance (including posturography) of a Y-balance task by explicit and analogical instructions. Forty female undergraduates were randomly assigned either into analogy ( n  = 20) or explicit ( n  = 20) learning. Both group learners completed pre-learning test-block on Day 1 (6 trials), five consecutive learning blocks from Days 3 to 7 (135 trials) and followed by test-blocks on Day 9 (retention 1 - dual-task - retention 2 design, 18 trials). Maximum reaching distances in anterior, posterolateral and posteromedial directions were measured to indicate Y-balance performance. During test-blocks (pre-learning, retention 1, dual-task, retention 2), CoM displacement and CoP excursion were quantified with the motion capturing system and force platform, respectively. Results indicated that maximum reach distances of two groups increased across learning days ( p  < .001). During test-blocks, explicit learners reduced maximum reaching distances under the dual-task test than the retention test 1 ( p  < .001), while analogy learners remained robust performance across test-blocks ( p  = .071). Moreover, analogy learners reported fewer explicit knowledge and demonstrated better counting backward performance than explicit learners. These findings suggest that introducing an analogical instruction in dynamic balance training is feasible and has implications to develop balance training strategies for injury prevention and performance enhancement.",2020,Results indicated that maximum reach distances of two groups increased across learning days ( p <.001).,['Forty female undergraduates'],['analogical instruction'],"['CoM displacement and CoP excursion', 'explicit knowledge', 'maximum reach distances']","[{'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}]","[{'cui': 'C0009490', 'cui_str': 'Comoros islands'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C0056471', 'cui_str': 'creatinolfosfate'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0012751', 'cui_str': 'Distance'}]",,0.0299465,Results indicated that maximum reach distances of two groups increased across learning days ( p <.001).,"[{'ForeName': 'Sung-Min', 'Initials': 'SM', 'LastName': 'Kim', 'Affiliation': ""Guangdong Provincial Engineering Technology Research Center for Sports Assistive Devices, Guangzhou Sport University, Guangzhou, People's Republic of China.""}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Qu', 'Affiliation': ""Biomechanics Laboratory, Beijing Sports University, Beijing, People's Republic of China.""}, {'ForeName': 'Wing-Kai', 'Initials': 'WK', 'LastName': 'Lam', 'Affiliation': ""Guangdong Provincial Engineering Technology Research Center for Sports Assistive Devices, Guangzhou Sport University, Guangzhou, People's Republic of China.""}]",European journal of sport science,['10.1080/17461391.2020.1827046']
2832,32949941,Exploring the use of Immersive Virtual Reality to enhance Psychological Well-Being in Pediatric Oncology: A pilot randomized controlled trial.,"PURPOSE


To investigate whether Immersive Virtual Reality (VR) has a greater positive influence on oncology patients' physical and emotional mood states when compared to an iPad attentional control condition. Our secondary objective was to understand what factors influenced VR effectiveness.
METHOD


Participants were 90 oncology inpatients, aged 7-19 years, and their primary parent caregiver. Using a randomized controlled study design patients were allocated to VR (three content groups) or an iPad control condition. Pre-post-intervention self-report state measures were collected using visual analogue scales and an objective measure of physiological arousal (pulse rate). Post-intervention, patients reported on level of immersion, enjoyment and simulator sickness.
RESULTS


Patients benefited from both Immersive VR and novel iPad intervention with no statistically significant differences found between conditions on child outcomes. However, patients accessing Immersive VR consistently reported greater positive shifts in mood state and reductions in negative symptoms when compared with iPad. No change was observed in physiological arousal levels (pulse rate) in either condition before, during or immediately after intervention. Moderation analysis showed that the degree of child illness (PedsQL), sex, age, and level of immersion were important in influencing the magnitude of differences between the VR and iPad conditions on mood, anxiety and pain.
CONCLUSIONS


These preliminary findings support the use of Immersive VR in clinical oncology settings to improve patient well-being. Further studies examining the application of Immersive VR in supporting children adjusting to hospitalization and cancer treatment are therefore warranted. Factors found to moderate VR effectiveness provide important clinical implications.",2020,"RESULTS


Patients benefited from both Immersive VR and novel iPad intervention with no statistically significant differences found between conditions on child outcomes.","['Participants were 90 oncology inpatients, aged 7-19 years, and their primary parent caregiver', 'Pediatric Oncology']","['Immersive VR', 'Immersive Virtual Reality', 'Immersive Virtual Reality (VR', 'iPad control condition']","['physiological arousal levels (pulse rate', 'physiological arousal (pulse rate', 'mood, anxiety and pain', 'level of immersion, enjoyment and simulator sickness', 'VR effectiveness', 'degree of child illness (PedsQL), sex, age, and level of immersion', 'negative symptoms']","[{'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C1518931', 'cui_str': 'Pediatric oncology'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0232117', 'cui_str': 'Pulse rate'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0020940', 'cui_str': 'Immersion'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0183309', 'cui_str': 'Simulator'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",90.0,0.0255989,"RESULTS


Patients benefited from both Immersive VR and novel iPad intervention with no statistically significant differences found between conditions on child outcomes.","[{'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Tennant', 'Affiliation': ""School of Psychology, Faculty of Health, Deakin University, Geelong, Victoria, 3220, Australia; Clinical Sciences, Murdoch Children's Research Institute, Parkville, Victoria, 3052, Australia; Children's Cancer Centre, The Royal Children's Hospital, Parkville, Victoria, 3052, Australia. Electronic address: michelle.tennant@mcri.edu.au.""}, {'ForeName': 'George J', 'Initials': 'GJ', 'LastName': 'Youssef', 'Affiliation': ""School of Psychology, Faculty of Health, Deakin University, Geelong, Victoria, 3220, Australia; Centre for Adolescent Health, Murdoch Children's Research Institute, Parkville, Victoria, 3052, Australia.""}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'McGillivray', 'Affiliation': 'School of Psychology, Faculty of Health, Deakin University, Geelong, Victoria, 3220, Australia; Deakin Child Study Centre, School of Psychology, Deakin University, Burwood, Victoria, 3125, Australia.'}, {'ForeName': 'Tara-Jane', 'Initials': 'TJ', 'LastName': 'Clark', 'Affiliation': ""Children's Cancer Centre, The Royal Children's Hospital, Parkville, Victoria, 3052, Australia.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'McMillan', 'Affiliation': ""Clinical Sciences, Murdoch Children's Research Institute, Parkville, Victoria, 3052, Australia.""}, {'ForeName': 'Maria C', 'Initials': 'MC', 'LastName': 'McCarthy', 'Affiliation': ""Clinical Sciences, Murdoch Children's Research Institute, Parkville, Victoria, 3052, Australia; Children's Cancer Centre, The Royal Children's Hospital, Parkville, Victoria, 3052, Australia; Department of Paediatrics, University of Melbourne, Parkville, Victoria, 3052, Australia.""}]",European journal of oncology nursing : the official journal of European Oncology Nursing Society,['10.1016/j.ejon.2020.101804']
2833,32955455,Social and Behavior Change Communication Interventions Delivered Face-to-Face and by a Mobile Phone to Strengthen Vaccination Uptake and Improve Child Health in Rural India: Randomized Pilot Study.,"BACKGROUND


In resource-poor settings, lack of awareness and low demand for services constitute important barriers to expanding the coverage of effective interventions. In India, childhood immunization is a priority health strategy with suboptimal uptake.
OBJECTIVE


To assess study feasibility and key implementation outcomes for the Tika Vaani model, a new approach to educate and empower beneficiaries to improve immunization and child health.
METHODS


A cluster-randomized pilot trial with a 1:1 allocation ratio was conducted in rural Uttar Pradesh, India, from January to September 2018. Villages were randomly assigned to either the intervention or control group. In each participating village, surveyors conducted a complete enumeration to identify eligible households and requested participation before randomization. Interventions were designed through formative research using a social marketing approach and delivered over 3 months using strategies adapted to disadvantaged populations: (1) mobile health (mHealth): entertaining educational audio capsules (edutainment) and voice immunization reminders via mobile phone and (2) face-to-face: community mobilization activities, including 3 small group meetings offered to each participant. The control group received usual services. The main outcomes were prespecified criteria for feasibility of the main study (recruitment, randomization, retention, contamination, and adoption). Secondary endpoints tested equity of coverage and changes in intermediate outcomes. Statistical methods included descriptive statistics to assess feasibility, penalized logistic regression and ordered logistic regression to assess coverage, and generalized estimating equation models to assess changes in intermediate outcomes.
RESULTS


All villages consented to participate. Gaps in administrative data hampered recruitment; 14.0% (79/565) of recorded households were nonresident. Only 1.4% (8/565) of households did not consent. A total of 387 households (184 intervention and 203 control) with children aged 0 to 12 months in 26 villages (13 intervention and 13 control) were included and randomized. The end line survey occurred during the flood season; 17.6% (68/387) of the households were absent. Contamination was less than 1%. Participation in one or more interventions was 94.0% (173/184), 78.3% (144/184) for the face-to-face strategy, and 67.4% (124/184) for the mHealth strategy. Determinants including place of residence, mobile phone access, education, and female empowerment shaped intervention use; factors operated differently for face-to-face and mHealth strategies. For 11 of 13 intermediate outcomes, regression results showed significantly higher basic health knowledge among the intervention group, supporting hypothesized causal mechanisms.
CONCLUSIONS


A future trial of a new intervention model is feasible. The interventions could strengthen the delivery of immunization and universal primary health care. Social and behavior change communication via mobile phones proved viable and contributed to standardization and scalability. Face-to-face interactions remain necessary to achieve equity and reach, suggesting the need for ongoing health system strengthening to accompany the introduction of communication technologies.
TRIAL REGISTRATION


International Standard Randomized Controlled Trial Number (ISRCTN) 44840759; https://doi.org/10.1186/ISRCTN44840759.",2020,"For 11 of 13 intermediate outcomes, regression results showed significantly higher basic health knowledge among the intervention group, supporting hypothesized causal mechanisms.
","['Rural India', '387 households (184 intervention and 203 control) with children aged 0 to 12 months in 26 villages (13 intervention and 13 control', 'rural Uttar Pradesh, India, from January to September 2018']","['Social and Behavior Change Communication Interventions Delivered Face-to-Face and by a Mobile Phone to Strengthen Vaccination Uptake', 'social marketing approach and delivered over 3 months using strategies adapted to disadvantaged populations: (1) mobile health (mHealth): entertaining educational audio capsules (edutainment) and voice immunization reminders via mobile phone and (2) face-to-face: community mobilization activities', 'usual services']","['equity of coverage and changes in intermediate outcomes', 'basic health knowledge', 'feasibility of the main study (recruitment, randomization, retention, contamination, and adoption']","[{'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C4517616', 'cui_str': '184'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}]","[{'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C1274143', 'cui_str': 'Communication interventions'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0037424', 'cui_str': 'Social Marketing'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0012613', 'cui_str': 'Disadvantaged'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0020971', 'cui_str': 'Immunization'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0001593', 'cui_str': 'Adoption'}]",387.0,0.0659548,"For 11 of 13 intermediate outcomes, regression results showed significantly higher basic health knowledge among the intervention group, supporting hypothesized causal mechanisms.
","[{'ForeName': 'Mira', 'Initials': 'M', 'LastName': 'Johri', 'Affiliation': ""Centre de Recherche du Centre Hospitalier de l'Université de Montréal (CRCHUM), Montréal, QC, Canada.""}, {'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Chandra', 'Affiliation': 'Independent consultant, New Delhi, India.'}, {'ForeName': 'Karna Georges', 'Initials': 'KG', 'LastName': 'Kone', 'Affiliation': ""Centre de Recherche du Centre Hospitalier de l'Université de Montréal (CRCHUM), Montréal, QC, Canada.""}, {'ForeName': 'Marie-Pierre', 'Initials': 'MP', 'LastName': 'Sylvestre', 'Affiliation': ""Centre de Recherche du Centre Hospitalier de l'Université de Montréal (CRCHUM), Montréal, QC, Canada.""}, {'ForeName': 'Alok K', 'Initials': 'AK', 'LastName': 'Mathur', 'Affiliation': 'Indian Institute of Health Management Research University, Jaipur, India.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Harper', 'Affiliation': 'Department of Epidemiology, Biostatistics & Occupational Health, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Arijit', 'Initials': 'A', 'LastName': 'Nandi', 'Affiliation': 'Department of Epidemiology, Biostatistics & Occupational Health, McGill University, Montreal, QC, Canada.'}]",JMIR mHealth and uHealth,['10.2196/20356']
2834,32950613,A 4-week exercise and protein program improves muscle mass and physical functioning in older adults - A pilot study.,"BACKGROUND


Prehabilitation might attenuate common surgery-induced losses in muscle mass and physical performance. Beneficial effects of physical exercise with protein supplementation have been reported in older adults, but typically after an intervention of at least 12 weeks. The time-window for pre-surgery training is often limited to around 30 days, and it is not known if it is possible to achieve comparable results in such a short time window.
OBJECTIVES


The aim of this study was to pilot-test the effectiveness of a controlled four-week combined exercise and protein supplementation program on skeletal muscle-related outcomes in a Dutch older adult population.
DESIGN


This study was a one-armed pilot trial.
PARTICIPANTS


Seventeen older men and women, aged 55-75y, not scheduled for surgery.
INTERVENTION


A 4-week intervention program consisting of a twice-weekly supervised resistance and high-intensity aerobic exercise training of 75 min, combined with daily protein supplementation (2 doses of 15.5 g/day at breakfast and lunch).
MEASUREMENT


After two and four weeks, isometric quadriceps maximal voluntary contraction (MVC) was assessed via Biodex and quadriceps cross-sectional area (CSA) via magnetic resonance imaging. Other outcome measures were handgrip strength, chair rise time and maximal aerobic capacity (VO 2 -max), as assessed from a submaximal exercise test.
RESULTS


Compliance to the supervised training sessions (99.3%) and the protein supplementation (97%) was very high. The 4-week exercise and protein program led to an increase in quadriceps CSA of 2.3 ± 0.7 cm 2  (P = 0.008) in the dominant leg and 3.2 ± 0.7 cm 2  (P < 0.001) in the non-dominant leg. Isometric quadriceps MVC increased in the dominant leg (Δ14 ± 4 Nm, P = 0.001) and in the non-dominant leg (Δ17 ± 5 Nm, P = 0.003). Chair rise test time improved with -3.8 ± 0.5 s (P < 0.0001), and VO 2 -max improved with 3.3 ± 1.1 ml/min/kg (P = 0.014). We observed no changes in body weight and handgrip strength.
CONCLUSION


A 4-week exercise and protein intervention led to improvements in muscle-related outcomes in older adults with low levels of physical activity.",2020,"Isometric quadriceps MVC increased in the dominant leg (Δ14 ± 4 Nm, P = 0.001) and in the non-dominant leg (Δ17 ± 5 Nm, P = 0.003).","['older adults', 'Seventeen older men and women, aged 55-75y, not scheduled for surgery', 'older adults with low levels of physical activity', 'Dutch older adult population']","['combined exercise and protein supplementation program', 'exercise and protein intervention', 'exercise and protein program', 'intensity aerobic exercise training of 75\u202fmin, combined with daily protein supplementation', 'physical exercise with protein supplementation']","['muscle mass and physical functioning', 'isometric quadriceps maximal voluntary contraction (MVC', 'Isometric quadriceps MVC', 'Chair rise test time', 'VO 2 -max', 'handgrip strength, chair rise time and maximal aerobic capacity (VO 2 -max), as assessed from a submaximal exercise test', 'body weight and handgrip strength']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0770246', 'cui_str': 'Protein supplementation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0429928', 'cui_str': 'Test time'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]",17.0,0.0475282,"Isometric quadriceps MVC increased in the dominant leg (Δ14 ± 4 Nm, P = 0.001) and in the non-dominant leg (Δ17 ± 5 Nm, P = 0.003).","[{'ForeName': 'Pol', 'Initials': 'P', 'LastName': 'Grootswagers', 'Affiliation': 'Division of Human Nutrition and Health, Wageningen University, P.O. Box 17, 6700 AA Wageningen, the Netherlands. Electronic address: pol.grootswagers@wur.nl.'}, {'ForeName': 'Margot', 'Initials': 'M', 'LastName': 'de Regt', 'Affiliation': 'Department of Physical Therapy, Gelderse Vallei Hospital, Ede, the Netherlands.'}, {'ForeName': 'Jacintha', 'Initials': 'J', 'LastName': 'Domić', 'Affiliation': 'Division of Human Nutrition and Health, Wageningen University, P.O. Box 17, 6700 AA Wageningen, the Netherlands.'}, {'ForeName': 'Jaap', 'Initials': 'J', 'LastName': 'Dronkers', 'Affiliation': 'Department of Physical Therapy, Gelderse Vallei Hospital, Ede, the Netherlands; Research group Innovation and Movement Care, University of Applied Science, Utrecht, the Netherlands.'}, {'ForeName': 'Marlieke', 'Initials': 'M', 'LastName': 'Visser', 'Affiliation': 'Science Office, Gelderse Vallei Hospital, Ede, the Netherlands.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Witteman', 'Affiliation': 'Division of Human Nutrition and Health, Wageningen University, P.O. Box 17, 6700 AA Wageningen, the Netherlands; Department of Physical Therapy, Gelderse Vallei Hospital, Ede, the Netherlands.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Hopman', 'Affiliation': 'Department of Physiology, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Mensink', 'Affiliation': 'Division of Human Nutrition and Health, Wageningen University, P.O. Box 17, 6700 AA Wageningen, the Netherlands.'}]",Experimental gerontology,['10.1016/j.exger.2020.111094']
2835,32950645,Rationale and protocol for translating basic habituation research into family-based childhood obesity treatment: Families becoming healthy together study.,"This publication describes the rationale and protocol, including design, aims, intervention, and measures, of Families Becoming Healthy Together, a randomized clinical trial examining the effect of a limited RED (non-nutrient-dense, energy-dense) food variety prescription delivered within an 18-month family-based behavioral obesity treatment (FBT) on body mass index (BMI) and habituation rate to RED foods. One hundred fifty-six children (ages: 8-12 y; BMI: ≥ 85th percentile-for-age) and a caregiver (BMI: ≥ 25 kg/m 2 ), both with overweight or obesity, will be randomized to one of two, interventions: FBT or FBT + Variety. All participants will receive 29 sessions of FBT and be prescribed the Traffic Light Diet (1000-1500 kcal/day, ≤ 2 RED food servings/day), and a physical activity goal (≥ 60 min/day [child] or 150 min/week [adult] of moderate-vigorous physical activity (MVPA)). FBT + Variety will also identify two RED foods, a dinner entrée and snack food, and develop meal plans that reduce variety of RED foods by regularly consuming these foods and limiting consumption of other RED foods. Measures of anthropometrics, dietary intake, habituation of salivary response to food cues, and physical activity will be assessed at 0, 6, 12, and 18-months. This study translates a line of basic behavioral research examining how dietary variety influences habituation into a dietary prescription that will be tested within an efficacy trial. It is hypothesized that a novel, limited dietary variety prescription within FBT should promote a faster food habituation rate, reducing energy intake and amplifying long-term weight loss in children.",2020,One hundred fifty-six children (ages: 8-12,"['family-based childhood obesity treatment', 'One hundred fifty-six children (ages: 8-12', 'y; BMI: ≥ 85th percentile-for-age) and a caregiver (BMI: ≥ 25\u202fkg/m 2 ), both with overweight or obesity', 'children']","['FBT or FBT\u202f+\u202fVariety', 'FBT and be prescribed the Traffic Light Diet', 'physical activity goal (≥ 60\u202fmin/day [child] or 150\u202fmin/week [adult] of moderate-vigorous physical activity (MVPA', 'limited RED (non-nutrient-dense, energy-dense) food variety prescription delivered within an 18-month family-based behavioral obesity treatment (FBT']","['anthropometrics, dietary intake, habituation of salivary response to food cues, and physical activity', 'body mass index (BMI) and habituation rate to RED foods']","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C2362324', 'cui_str': 'Childhood obesity'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C4706528', 'cui_str': 'Obesity care'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0442664', 'cui_str': 'Traffic light'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0332575', 'cui_str': 'Red color'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0439794', 'cui_str': 'Dense'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0013170', 'cui_str': 'Drug habituation'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0332575', 'cui_str': 'Red color'}]",156.0,0.050562,One hundred fifty-six children (ages: 8-12,"[{'ForeName': 'Steve M', 'Initials': 'SM', 'LastName': 'Douglas', 'Affiliation': 'Department of Nutrition, University of Tennessee, Knoxville, TN, USA.'}, {'ForeName': 'Grace M', 'Initials': 'GM', 'LastName': 'Hawkins', 'Affiliation': 'Department of Nutrition, University of Tennessee, Knoxville, TN, USA.'}, {'ForeName': 'Kristoffer S', 'Initials': 'KS', 'LastName': 'Berlin', 'Affiliation': 'Department of Psychology, University of Memphis, Memphis, TN, USA.'}, {'ForeName': 'Scott E', 'Initials': 'SE', 'LastName': 'Crouter', 'Affiliation': 'Department of Kinesiology, Recreation, and Sport Studies, University of Tennessee, Knoxville, TN, USA.'}, {'ForeName': 'Leonard H', 'Initials': 'LH', 'LastName': 'Epstein', 'Affiliation': 'Department of Pediatrics, School of Medicine, and Biomedical Sciences, University at Buffalo, Buffalo, NY, USA.'}, {'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'Thomas', 'Affiliation': 'Weight Control and Diabetes Research Center, The Miriam Hospital/Brown Alpert Medical School, Providence, RI, USA.'}, {'ForeName': 'Hollie A', 'Initials': 'HA', 'LastName': 'Raynor', 'Affiliation': 'Department of Nutrition, University of Tennessee, Knoxville, TN, USA. Electronic address: hraynor@vols.utk.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106153']
2836,32951538,"Rationale, Design, and Implementation of Intensive Risk Factor Treatment in the CREST2 Trial.","BACKGROUND AND PURPOSE


The CREST2 trial (Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis) is comparing intensive medical management (IMM) alone to IMM plus revascularization with carotid endarterectomy or transfemoral carotid artery stenting for preventing stroke or death within 44 days after randomization or ipsilateral ischemic stroke thereafter. There are extensive clinical trial data on outcomes after revascularization of asymptomatic carotid stenosis, but not for IMM. As such, the experimental treatment in CREST2 is IMM, which is described in this article.
METHODS


IMM consists of aspirin 325 mg/day and intensive risk factor management, primarily targeting systolic blood pressure <130 mm Hg (initially systolic blood pressure <140 mm Hg) and LDL (low-density lipoprotein) cholesterol <70 mg/dL. Secondary risk factor targets focus on tobacco smoking, non-HDL (high-density lipoprotein), HbA1c (hemoglobin A1c), physical activity, and weight. Risk factor management is performed by site personnel and a lifestyle coaching program delivered by telephone. We report interim risk factor data on 1618 patients at baseline and last follow-up through 24 months.
RESULTS


The mean baseline LDL of 80.5 mg/dL improved to 66.7 mg/dL. The mean baseline systolic blood pressure of 139.7 mm Hg improved to 130.3 mm Hg. The proportion of patients in-target improved from 43% to 61% for systolic blood pressure <130 mm Hg and from 45% to 67% for LDL<70 mg/dL (both changes  P <0.001).
CONCLUSIONS


The rigorous multimodal approach to intensive stroke risk factor management in CREST2 has resulted in significant improvements in risk factor control that will enable a comparison of cutting-edge medical care to revascularization in patients with asymptomatic carotid stenosis. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02089217.",2020,"The proportion of patients in-target improved from 43% to 61% for systolic blood pressure <130 mm Hg and from 45% to 67% for LDL<70 mg/dL (both changes  P <0.001).
","['1618 patients at baseline and last follow-up through 24 months', 'patients with asymptomatic carotid stenosis', 'Asymptomatic Carotid Stenosis']","['aspirin 325 mg/day and intensive risk factor management, primarily targeting systolic blood pressure <130 mm Hg (initially systolic blood pressure <140 mm Hg) and LDL (low-density lipoprotein) cholesterol <70 mg/dL. Secondary risk factor targets', 'IMM plus revascularization with carotid endarterectomy or transfemoral carotid artery stenting']","['tobacco smoking, non-HDL (high-density lipoprotein), HbA1c (hemoglobin A1c), physical activity, and weight', 'mean baseline LDL', 'systolic blood pressure', 'mean baseline systolic blood pressure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0007282', 'cui_str': 'Carotid artery stenosis'}]","[{'cui': 'C0992015', 'cui_str': 'Aspirin 325 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C1277632', 'cui_str': 'Target systolic blood pressure'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0014099', 'cui_str': 'Carotid endarterectomy'}, {'cui': 'C0007272', 'cui_str': 'Carotid artery structure'}]","[{'cui': 'C0453996', 'cui_str': 'Tobacco smoking behavior - finding'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C4274438', 'cui_str': 'Baseline systolic blood pressure'}]",1618.0,0.152957,"The proportion of patients in-target improved from 43% to 61% for systolic blood pressure <130 mm Hg and from 45% to 67% for LDL<70 mg/dL (both changes  P <0.001).
","[{'ForeName': 'Tanya N', 'Initials': 'TN', 'LastName': 'Turan', 'Affiliation': 'Neurology (T.N.T., J.H.V., M.I.C., A.R., T.L., W.H.), Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Jenifer H', 'Initials': 'JH', 'LastName': 'Voeks', 'Affiliation': 'Neurology (T.N.T., J.H.V., M.I.C., A.R., T.L., W.H.), Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Marc I', 'Initials': 'MI', 'LastName': 'Chimowitz', 'Affiliation': 'Neurology (T.N.T., J.H.V., M.I.C., A.R., T.L., W.H.), Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Roldan', 'Affiliation': 'Neurology (T.N.T., J.H.V., M.I.C., A.R., T.L., W.H.), Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'LeMatty', 'Affiliation': 'Neurology (T.N.T., J.H.V., M.I.C., A.R., T.L., W.H.), Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Haley', 'Affiliation': 'Neurology (T.N.T., J.H.V., M.I.C., A.R., T.L., W.H.), Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Lopes-Virella', 'Affiliation': 'Medicine (M.L.-V.), Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Seemant', 'Initials': 'S', 'LastName': 'Chaturvedi', 'Affiliation': 'Medical University of South Carolina, Charleston, SC. Neurology (S.C.), University of Maryland, Baltimore.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Jones', 'Affiliation': 'Cardiology, Baptist Health, Lexington, KY (M.J.).'}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Heck', 'Affiliation': 'Radiology, Novant Health, Winston-Salem, NC (D.H.).'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Howard', 'Affiliation': 'Biostatistics, University of Alabama at Birmingham (G.H.).'}, {'ForeName': 'Brajesh K', 'Initials': 'BK', 'LastName': 'Lal', 'Affiliation': 'Vascular Surgery (B.K.L.), University of Maryland, Baltimore.'}, {'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Meschia', 'Affiliation': 'Neurology, Mayo Clinic, Jacksonville, FL (J.F.M., T.G.B.).'}, {'ForeName': 'Thomas G', 'Initials': 'TG', 'LastName': 'Brott', 'Affiliation': 'Neurology, Mayo Clinic, Jacksonville, FL (J.F.M., T.G.B.).'}]",Stroke,['10.1161/STROKEAHA.120.030730']
2837,32951928,"Re: Fredrik Liedberg, Petter Kollberg, Marie Allerbo, et al. Preventing Parastomal Hernia After Ileal Conduit by the Use of a Prophylactic Mesh: A Randomised Study. Eur Urol. In press. https://doi.org/10.1016/j.eururo.2020.07.033.",,2020,,[],[],['Parastomal Hernia'],[],[],"[{'cui': 'C0341539', 'cui_str': 'Parastomal hernia'}]",,0.0222472,,"[{'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Ghoreifi', 'Affiliation': 'Institute of Urology, Norris Comprehensive Cancer Center, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Hooman', 'Initials': 'H', 'LastName': 'Djaladat', 'Affiliation': 'Institute of Urology, Norris Comprehensive Cancer Center, University of Southern California, Los Angeles, CA, USA. Electronic address: djaladat@med.usc.edu.'}]",European urology,['10.1016/j.eururo.2020.09.022']
2838,32954765,Effect of a two-way quality feedback nursing model on patients with chronic obstructive pulmonary disease.,"BACKGROUND


In recent years, the incidence of chronic obstructive pulmonary disease (COPD) has been increasing gradually, becoming a relatively intractable public health problem faced by all of society. The corresponding conventional nursing interventions are not effective for the rehabilitation of COPD patients and cannot meet clinical needs. In this study, a new nursing model, a two-way quality feedback nursing model, was applied for the treatment of COPD patients.
METHODS


This retrospective study included 120 moderate COPD patients admitted to our hospital between January 2018 and December 2018, and the patients were equally divided into the experimental group (n=60) and the control group (n=60) according to the nursing strategy received by patients. The control group received routine nursing care, the two-way quality feedback nursing model was applied in the experimental group, and the nursing effects in the two groups were compared.
RESULTS


The patient compliance of the experimental group to nursing care was 91.67%, that of the control group was 78.33% (P<0.05), and the scores for social relationship, environmental impact, psychological condition, and physiological condition of quality of life (QoL) in the experimental group at discharge were higher than those in the control group (P<0.05).
CONCLUSIONS


The application of the two-way quality feedback nursing model in COPD patients could improve patient compliance and significantly improve the QoL of patients, with good application value.",2020,"The patient compliance of the experimental group to nursing care was 91.67%, that of the control group was 78.33% (P<0.05), and the scores for social relationship, environmental impact, psychological condition, and physiological condition of quality of life (QoL) in the experimental group at discharge were higher than those in the control group (P<0.05).
","['patients with chronic obstructive pulmonary disease', 'chronic obstructive pulmonary disease (COPD', 'COPD patients', '120 moderate COPD patients admitted to our hospital between January 2018 and December 2018, and the patients were equally divided into the experimental group (n=60) and the control group (n=60) according to the nursing strategy received by patients']","['routine nursing care, the two-way quality feedback nursing model']","['scores for social relationship, environmental impact, psychological condition, and physiological condition of quality of life (QoL', 'nursing care']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0730605', 'cui_str': 'Moderate chronic obstructive pulmonary disease'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0332286', 'cui_str': 'Into'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0028678', 'cui_str': 'nursing'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0079849', 'cui_str': 'Model, Nursing'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0282165', 'cui_str': 'Environmental Impact'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0028678', 'cui_str': 'nursing'}]",120.0,0.0132109,"The patient compliance of the experimental group to nursing care was 91.67%, that of the control group was 78.33% (P<0.05), and the scores for social relationship, environmental impact, psychological condition, and physiological condition of quality of life (QoL) in the experimental group at discharge were higher than those in the control group (P<0.05).
","[{'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Cai', 'Affiliation': 'Department of Geriatrics, Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School, Nanjing, China.'}, {'ForeName': 'Yinhua', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Department of Geriatrics, Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School, Nanjing, China.'}, {'ForeName': 'Xiaolan', 'Initials': 'X', 'LastName': 'Deng', 'Affiliation': 'Department of Geriatrics, Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School, Nanjing, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Fang', 'Affiliation': 'Department of Geriatrics, Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School, Nanjing, China. fangfang7778@126.com.'}]",Annals of palliative medicine,['10.21037/apm-20-1532']
2839,32956506,Alkalinized lidocaine solution as a first-line local anesthesia protocol for intradetrusor injection of onabotulinum toxin A: Results from a double-blinded randomized controlled trial.,"AIMS


Local anesthesia protocols for intradetrusor onabotulinum toxin A (BoNTA) injection lack standardization. We aimed to determine if an alkalinized lidocaine solution is more effective than lidocaine only.
METHODS


Patients of both genders aged 18 or above enlisted for intradetrusor BoNTA injection (idiopathic, neurogenic, and bladder pain syndrome) were included in a double-blinded randomized controlled trial after obtaining their informed consent. All participants filled a bladder diary and a urine culture was performed. Subjects were randomized 1:1 to Protocol A (20 ml 2% lidocaine + 10 ml 8.4% sodium bicarbonate) or Protocol B (20 ml 2% lidocaine + 10 ml 0.9% saline solution). A Numeric Rating Scale (0-10) was used to assess the level of pain immediately after the procedure (primary endpoint). Secondary endpoints included pain after 1 h, urinary tract infection, acute urinary retention, and hematuria related to the procedure.
RESULTS


A total of 116 patients were randomized. Baseline characteristics (age, sex, indication, and bladder diary parameters) of patients in Group A and B were similar. Pain scores at the end of the procedure were significantly lower with the alkalinized solution (Protocol A and B, respectively, 2.37 ± 0.31 vs. 4.44 ± 0.36, p < .01). No differences were observed 1 h after treatment (Protocol A and B, respectively, 0.54 ± 0.17 vs. 0.69 ± 0.19, p = .487). The only adverse event reported was mild-to-moderate self-limited hematuria in 15.4% of patients.
CONCLUSIONS


The use of an alkalinized lidocaine solution has proven to be significantly superior to lidocaine only as local anesthesia before intradetrusor BoNTA injection, suggesting that this may be considered a first-line option.",2020,"Pain scores at the end of the procedure were significantly lower with the alkalinized solution (Protocol A and B, respectively, 2.37 ± 0.31 vs. 4.44 ± 0.36, p < .01).","['Patients of both genders aged 18 or above enlisted for intradetrusor BoNTA injection (idiopathic, neurogenic, and bladder pain syndrome', '116 patients were randomized']","['Alkalinized lidocaine solution', 'lidocaine\u2009+\u200910\u2009ml 8.4% sodium bicarbonate) or Protocol B (20\u2009ml 2% lidocaine\u2009', 'lidocaine', 'alkalinized lidocaine solution']","['level of pain', 'Pain scores', 'pain after 1\u2009h, urinary tract infection, acute urinary retention, and hematuria related to the procedure', 'Numeric Rating Scale']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C1720830', 'cui_str': 'Bladder Pain Syndrome'}, {'cui': 'C4517541', 'cui_str': '116'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C4517876', 'cui_str': '8.4'}, {'cui': 'C0074722', 'cui_str': 'Sodium Bicarbonate'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0341742', 'cui_str': 'Acute retention of urine'}, {'cui': 'C0018965', 'cui_str': 'Blood in urine'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",116.0,0.555031,"Pain scores at the end of the procedure were significantly lower with the alkalinized solution (Protocol A and B, respectively, 2.37 ± 0.31 vs. 4.44 ± 0.36, p < .01).","[{'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Pereira E Silva', 'Affiliation': 'Department of Urology, Centro Hospitalar Universitário Lisboa Norte, Lisboa, Portugal.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Ponte', 'Affiliation': 'Department of Urology, Centro Hospitalar Universitário Lisboa Norte, Lisboa, Portugal.'}, {'ForeName': 'Filipe', 'Initials': 'F', 'LastName': 'Lopes', 'Affiliation': 'Department of Urology, Centro Hospitalar Universitário Lisboa Norte, Lisboa, Portugal.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Palma Dos Reis', 'Affiliation': 'Department of Urology, Centro Hospitalar Universitário Lisboa Norte, Lisboa, Portugal.'}]",Neurourology and urodynamics,['10.1002/nau.24519']
2840,32956551,The effect of immediate implant placement on alveolar ridge preservation compared to spontaneous healing after tooth extraction: Soft tissue findings from a randomized controlled clinical trial.,"AIM


To compare soft tissue dimensional changes and relative differences in soft and hard tissue volumes 4 months after single-tooth extraction and three different treatment modalities: spontaneous healing (SH) and alveolar ridge preservation by means of a deproteinized bovine bone mineral and a collagen matrix, with (IMPL/DBBM/CM) or without (DBBM/CM) immediate implant placement.
MATERIALS AND METHODS


STL files from study casts obtained at baseline and after 4 months were matched to calculate buccal soft tissue linear and volumetric changes. DICOM files from CBCTs were superimposed to STL files allowing the evaluation of soft tissue thickness at baseline and 4 months.
RESULTS


Mean horizontal reduction accounted for 1.46 ± 0.20 (SH), 0.85 ± 0.38 (DBBM-CM) and 0.84 ± 0.30 IMPL/DBBM-CM, with no statistical differences. Soft tissue thickness had a significant mean increase of 0.95 for SH group, compared to a non-significant mean decrease for DBBM-CM (0.20) and IMPL/DBBM-CM groups (0.07).
CONCLUSION


A preservation technique with DBBM-CM, with or without immediate implant placement, did not reduce the horizontal linear and volumetric changes at the buccal soft tissue profile significantly at 4 months after tooth extraction when compared to spontaneous healing. This is due to a significant increase in soft tissue thickness in spontaneously healing sites.",2020,", didn't reduce the horizontal linear and volumetric changes at the buccal soft tissue profile significantly at 4 months after tooth extraction when compared to spontaneous healing.",[],"['deproteneized bovine bone mineral and a collagen matrix, with (IMPL/DBBM/CM) or without (DBBM/CM) immediate implant placement', 'immediate implant placement', 'DBBM-CM, with or without immediate implant placement']","['Soft tissue thickness', 'soft tissue thickness', 'alveolar ridge preservation', 'horizontal linear and volumetric changes at the buccal soft tissue profile', 'DBBM-CM', 'mean horizontal reduction']",[],"[{'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0447411', 'cui_str': 'Alveolar ridge structure'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0445383', 'cui_str': 'Volumetric'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",,0.0258817,", didn't reduce the horizontal linear and volumetric changes at the buccal soft tissue profile significantly at 4 months after tooth extraction when compared to spontaneous healing.","[{'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Clementini', 'Affiliation': 'Department of Periodontology, Ospedale San Raffaele, Università Vita-Salute, Milan, Italy.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Castelluzzo', 'Affiliation': 'Department of Periodontology, Ospedale San Raffaele, Università Vita-Salute, Milan, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Ciaravino', 'Affiliation': 'Department of Periodontology, Ospedale San Raffaele, Università Vita-Salute, Milan, Italy.'}, {'ForeName': 'Agnese', 'Initials': 'A', 'LastName': 'Agostinelli', 'Affiliation': 'Department of Periodontology, Ospedale San Raffaele, Università Vita-Salute, Milan, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Vignoletti', 'Affiliation': 'Department of Periodontology, Ospedale San Raffaele, Università Vita-Salute, Milan, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Ambrosi', 'Affiliation': 'Department of Periodontology, Ospedale San Raffaele, Università Vita-Salute, Milan, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'De Sanctis', 'Affiliation': 'Department of Periodontology, Ospedale San Raffaele, Università Vita-Salute, Milan, Italy.'}]",Journal of clinical periodontology,['10.1111/jcpe.13369']
2841,32956682,"A feasibility study of application and potential effects of a single session transcranial direct current stimulation (tDCS) on competitive anxiety, mood state, salivary levels of cortisol and alpha amylase in elite athletes under a real-world competition.","OBJECTIVE


To examine feasibility and potential effects of a single session tDCS over the dorsolateral prefrontal cortex (DLPFC) on competitive anxiety, mood state, and autonomic and endocrine stress responses in elite archer athletes under a real world competition.
METHODS


Twelve male elite archers volunteered to participate in this pilot trial. Participants were randomized in order to take left anodal DLPFC, left cathodal DLPFC, or sham stimulation (the F3 or F4 areas according to the 10/20 EEG International System) in a within-subject study design. This study included three official competitions. About 45 min before the competition, the tDCS stimulation process was started and the participants were stimulated for 20 min with 2 mA current. Psychophysiological responses, including Brunel Mood Scale and Competitive state anxiety inventory-2-revied, were collected 15 min before each competition. Additionally, salivary cortisol (sCort) and salivary alpha-amylase (sAA) were collected 1 hour and 10 min before competition as well as 10 min and 1 hour after competition.
RESULTS


Findings demonstrated that anodal tDCS was feasible and could lead to enhance mood state (vigor, tension and fatigue) and a decrease in competitive anxiety, as compared to cathodal and sham stimulation (all p < 0.05). However, self-confidence remained unaffected by the tDCS (p > 0.05). Anodal stimulation resulted in a lower salivary cortisol and alpha-amylase response (all p < 0.05). Correlations between competitive anxiety and mood states with physiological stress markers (sCort and sAA) were not significant (all p > 0.05).
CONCLUSIONS


The present study provides the first preliminary evidence that anodal tDCS over the DLPFC is feasible and could modulate competitive anxiety and physiological stress responses to the acute stress of competition (potentially by a top-down regulation of HPA and SAM systems as well as the vagal system). Findings support the notion that non-invasive brain stimulation might be advantageous to enhance sport performance under competitive situations. However, additional studies in a larger sample size and different sport activities are encouraged to substantiate the findings.",2020,Anodal stimulation resulted in a lower salivary cortisol and alpha-amylase response (all p < 0.05).,"['elite athletes under a real-world competition', 'elite archer athletes under a real world competition', 'Twelve male elite archers volunteered to participate in this pilot trial']","['anodal tDCS', 'single session transcranial Direct Current Stimulation (tDCS', 'left anodal DLPFC, left cathodal DLPFC, or sham stimulation (the F3 or F4 areas according to the 10/20 EEG International System', 'single session tDCS']","['lower salivary cortisol and alpha-amylase response', 'competitive anxiety and mood states with physiological stress markers (sCort and sAA', 'competitive anxiety, mood state, salivary levels of cortisol and alpha amylase', 'competitive anxiety', 'competitive anxiety, mood state, and autonomic and endocrine stress responses', 'Psychophysiological responses, including Brunel Mood Scale and Competitive State Anxiety inventory-2-Revied', 'salivary cortisol (sCort) and salivary alpha-amylase (sAA', 'enhance mood state (vigor, tension and fatigue']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0002245', 'cui_str': 'alpha-Amylase'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0449430', 'cui_str': 'Physiological stress'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C2350322', 'cui_str': 'Salivary alpha-Amylases'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0014136', 'cui_str': 'Structure of endocrine system'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0233494', 'cui_str': 'Tension'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",12.0,0.0310646,Anodal stimulation resulted in a lower salivary cortisol and alpha-amylase response (all p < 0.05).,"[{'ForeName': 'Amir Hossien', 'Initials': 'AH', 'LastName': 'Mehrsafar', 'Affiliation': 'Department of Sport Psychology, Faculty of Sport Sciences, University of Tehran, Tehran, Iran. Electronic address: a.mehrsafar@ut.ac.ir.'}, {'ForeName': 'Miguel Angel Serrano', 'Initials': 'MAS', 'LastName': 'Rosa', 'Affiliation': 'Department of Psychobiology, Faculty of Psychology, University of Valencia, Valencia, Spain; Laboratory of Cognitive and Affective Neuroscience, Faculty of psychology, University of Valencia, Valencia, Spain. Electronic address: m.angel.serrano@uv.es.'}, {'ForeName': 'Ali Moghadam', 'Initials': 'AM', 'LastName': 'Zadeh', 'Affiliation': 'Department of Psychology, Faculty of Psychology and Education, University of Tehran, Tehran, Iran. Electronic address: amoghadamzadeh@ut.ac.ir.'}, {'ForeName': 'Parisa', 'Initials': 'P', 'LastName': 'Gazerani', 'Affiliation': 'Department of Health Science and Technology, Faculty of Medicine, Aalborg University, Aalborg E, Denmark. Electronic address: gazerani@hst.aau.dk.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113173']
2842,32969828,Development and Evaluation of an Accelerometer-Based Protocol for Measuring Physical Activity Levels in Cancer Survivors: Development and Usability Study.,"BACKGROUND


The collection of self-reported physical activity using validated questionnaires has known bias and measurement error.
OBJECTIVE


Accelerometry, an objective measure of daily activity, increases the rigor and accuracy of physical activity measurements. Here, we describe the methodology and related protocols for accelerometry data collection and quality assurance using the Actigraph GT9X accelerometer data collection in a convenience sample of ovarian cancer survivors enrolled in GOG/NRG 0225, a 24-month randomized controlled trial of diet and physical activity intervention versus attention control.
METHODS


From July 2015 to December 2019, accelerometers were mailed on 1337 separate occasions to 580 study participants to wear at 4 time points (baseline, 6, 12, and 24 months) for 7 consecutive days. Study staff contacted participants via telephone to confirm their availability to wear the accelerometers and reviewed instructions and procedures regarding the return of the accelerometers and assisted with any technology concerns.
RESULTS


We evaluated factors associated with wear compliance, including activity tracking, use of a mobile app, and demographic characteristics with chi-square tests and logistic regression. Compliant data, defined as ≥4 consecutive days with ≥10 hours daily wear time, exceeded 90% at all study time points. Activity tracking, but no other characteristics, was significantly associated with compliant data at all time points (P<.001). This implementation of data collection through accelerometry provided highly compliant and usable activity data in women who recently completed treatment for ovarian cancer.
CONCLUSIONS


The high compliance and data quality associated with this protocol suggest that it could be disseminated to support researchers who seek to collect robust objective activity data in cancer survivors residing in a wide geographic area.",2020,"Activity tracking, but no other characteristics, was significantly associated with compliant data at all time points (P<.001).","['Cancer Survivors', 'From July 2015 to December 2019, accelerometers were mailed on 1337 separate occasions to 580 study participants to wear at 4 time points (baseline, 6, 12, and 24 months) for 7 consecutive days', 'women who recently completed treatment for ovarian cancer', 'convenience sample of ovarian cancer survivors enrolled in GOG/NRG 0225']","['Accelerometer-Based Protocol', 'Actigraph GT9X accelerometer data collection', 'diet and physical activity intervention versus attention control']","['rigor and accuracy of physical activity measurements', 'Activity tracking', 'wear compliance, including activity tracking, use of a mobile app, and demographic characteristics']","[{'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C4517818', 'cui_str': '580'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0026837', 'cui_str': 'Muscle rigidity'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}]",580.0,0.0624126,"Activity tracking, but no other characteristics, was significantly associated with compliant data at all time points (P<.001).","[{'ForeName': 'Tracy E', 'Initials': 'TE', 'LastName': 'Crane', 'Affiliation': 'Department of Biobehavioral Health Sciences, College of Nursing, University of Arizona, Tucson, AZ, United States.'}, {'ForeName': 'Meghan B', 'Initials': 'MB', 'LastName': 'Skiba', 'Affiliation': 'Department of Health Promotion Sciences, Mel and Enid Zuckerman College of Public Health, University of Arizona, Tucson, AZ, United States.'}, {'ForeName': 'Austin', 'Initials': 'A', 'LastName': 'Miller', 'Affiliation': 'Department of Biostatistics, Roswell Park Cancer Institute, Buffalo, NY, United States.'}, {'ForeName': 'David O', 'Initials': 'DO', 'LastName': 'Garcia', 'Affiliation': 'Department of Health Promotion Sciences, Mel and Enid Zuckerman College of Public Health, University of Arizona, Tucson, AZ, United States.'}, {'ForeName': 'Cynthia A', 'Initials': 'CA', 'LastName': 'Thomson', 'Affiliation': 'Department of Health Promotion Sciences, Mel and Enid Zuckerman College of Public Health, University of Arizona, Tucson, AZ, United States.'}]",JMIR mHealth and uHealth,['10.2196/18491']
2843,32969832,Stories to Communicate Individual Risk for Opioid Prescriptions for Back and Kidney Stone Pain: Protocol for the Life STORRIED Multicenter Randomized Clinical Trial.,"BACKGROUND


Prescription opioid misuse in the United States is a devastating public health crisis; many chronic opioid users were originally prescribed this class of medication for acute pain. Video narrative-enhanced risk communication may improve patient outcomes, such as knowledge of opioid risk and opioid use behaviors after an episode of acute pain.
OBJECTIVE


Our objective is to assess the effect of probabilistic and narrative-enhanced opioid risk communication on patient-reported outcomes, including knowledge, opioid use, and patient preferences, for patients who present to emergency departments with back pain and kidney stone pain.
METHODS


This is a multisite randomized controlled trial. Patients presenting to the acute care facilities of four geographically and ethnically diverse US hospital centers with acute renal colic pain or musculoskeletal back and/or neck pain are eligible for this randomized controlled trial. A control group of patients receiving general risk information is compared to two intervention groups: one receiving the risk information sheet plus an individualized, visual probabilistic Opioid Risk Tool (ORT) and another receiving the risk information sheet plus a video narrative-enhanced probabilistic ORT. We will study the effect of probabilistic and narrative-enhanced opioid risk communication on the following: risk awareness and recall at 14 days postenrollment, reduced use or preferences for opioids after the emergency department episode, and alignment with patient preference and provider prescription. To assess these outcomes, we administer baseline patient surveys during acute care admission and follow-up surveys at predetermined times during the 3 months after discharge.
RESULTS


A total of 1302 patients were enrolled over 24 months. The mean age of the participants was 40 years (SD 14), 692 out of 1302 (53.15%) were female, 556 out of 1302 (42.70%) were White, 498 out of 1302 (38.25%) were Black, 1002 out of 1302 (76.96%) had back pain, and 334 out of 1302 (25.65%) were at medium or high risk. Demographics and ORT scores were equally distributed across arms.
CONCLUSIONS


This study seeks to assess the potential clinical role of narrative-enhanced, risk-informed communication for acute pain management in acute care settings. This paper outlines the protocol used to implement the study and highlights crucial methodological, statistical, and stakeholder involvement as well as dissemination considerations.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03134092; https://clinicaltrials.gov/ct2/show/NCT03134092.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/19496.",2020,"Video narrative-enhanced risk communication may improve patient outcomes, such as knowledge of opioid risk and opioid use behaviors after an episode of acute pain.
","['Patients presenting to the acute care facilities of four geographically and ethnically diverse US hospital centers with acute renal colic pain or musculoskeletal back and/or neck pain', 'mean age of the participants was 40 years (SD 14), 692 out of 1302 (53.15%) were female, 556 out of 1302 (42.70%) were White, 498 out of 1302 (38.25%) were Black, 1002 out of 1302 (76.96', '1302 patients were enrolled over 24 months', 'patients who present to emergency departments with back pain and kidney stone pain']","['risk information sheet plus an individualized, visual probabilistic Opioid Risk Tool (ORT) and another receiving the risk information sheet plus a video narrative-enhanced probabilistic ORT', 'probabilistic and narrative-enhanced opioid risk communication']","['Demographics and ORT scores', 'back pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0152169', 'cui_str': 'Renal colic'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0004600', 'cui_str': 'Back'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517811', 'cui_str': '556'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0022650', 'cui_str': 'Kidney stone'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0439643', 'cui_str': 'Sheets'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C1135957', 'cui_str': 'Narration'}, {'cui': 'C0009452', 'cui_str': 'Communication'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0004604', 'cui_str': 'Backache'}]",1302.0,0.114005,"Video narrative-enhanced risk communication may improve patient outcomes, such as knowledge of opioid risk and opioid use behaviors after an episode of acute pain.
","[{'ForeName': 'Zachary F', 'Initials': 'ZF', 'LastName': 'Meisel', 'Affiliation': 'Center for Emergency Care Policy and Research, Department of Emergency Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Erica B', 'Initials': 'EB', 'LastName': 'Goldberg', 'Affiliation': 'Center for Emergency Care Policy and Research, Department of Emergency Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Abby R', 'Initials': 'AR', 'LastName': 'Dolan', 'Affiliation': 'Center for Emergency Care Policy and Research, Department of Emergency Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Esha', 'Initials': 'E', 'LastName': 'Bansal', 'Affiliation': 'Center for Emergency Care Policy and Research, Department of Emergency Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Karin V', 'Initials': 'KV', 'LastName': 'Rhodes', 'Affiliation': 'Department of Population Health Management, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Manhasset, NY, United States.'}, {'ForeName': 'Erik P', 'Initials': 'EP', 'LastName': 'Hess', 'Affiliation': 'Department of Emergency Medicine, University of Alabama at Birmingham, Birmingham, AL, United States.'}, {'ForeName': 'Carolyn C', 'Initials': 'CC', 'LastName': 'Cannuscio', 'Affiliation': 'Center for Emergency Care Policy and Research, Department of Emergency Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Marilyn M', 'Initials': 'MM', 'LastName': 'Schapira', 'Affiliation': 'Department of General and Internal Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Jeanmarie', 'Initials': 'J', 'LastName': 'Perrone', 'Affiliation': 'Center for Emergency Care Policy and Research, Department of Emergency Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Melissa A', 'Initials': 'MA', 'LastName': 'Rodgers', 'Affiliation': 'Center for Emergency Care Policy and Research, Department of Emergency Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Michael M', 'Initials': 'MM', 'LastName': 'Zyla', 'Affiliation': 'Center for Emergency Care Policy and Research, Department of Emergency Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Jeffrey J', 'Initials': 'JJ', 'LastName': 'Bell', 'Affiliation': 'Center for Emergency Care Policy and Research, Department of Emergency Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'McCollum', 'Affiliation': 'Center for Emergency Care Policy and Research, Department of Emergency Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Frances S', 'Initials': 'FS', 'LastName': 'Shofer', 'Affiliation': 'Center for Emergency Care Policy and Research, Department of Emergency Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States.'}]",JMIR research protocols,['10.2196/19496']
2844,32970315,"Bioequivalence Study Comparing Fixed-Dose Combination of Clopidogrel and Aspirin with Coadministration of Individual Formulations in Chinese Subjects Under Fed Conditions: A Phase I, Open-Label, Randomized, Crossover Study.","INTRODUCTION


Simultaneous administration of acetylsalicylic acid (ASA) and clopidogrel has demonstrated efficacy in the treatment of acute coronary syndrome. Clopidogrel + ASA in a fixed-dose combination (FDC) provides a pharmaceutical option to enhance adherence to the coadministration of dual antiplatelet therapy (DAPT). Herein, we evaluate the bioequivalence of enteric ASA and clopidogrel in an FDC compared with simultaneous administration of the individual formulations.
METHODS


This study is a randomized, single-center, open-label, three-sequence, three-period, two-treatment, crossover study conducted in healthy Chinese male and female subjects under fed conditions. Subjects were randomized to receive, in each period, a single dose of (1) a combination tablet containing 75-mg clopidogrel and 100-mg enteric ASA (test formulation) or (2) coadministration of one 75-mg clopidogrel tablet and one 100-mg enteric-coated ASA tablet (reference formulations) under fed conditions. Plasma samples were analyzed for ASA, salicylic acid, clopidogrel, and the clopidogrel metabolite SR26334. For ASA, the reference-scaled average bioequivalence (RSABE) analysis was conducted for C max  of ASA because within-subject standard deviation (SD W ) was ≥ 0.294 for log-transformed C max .
RESULTS


The point estimate (test/reference geometric mean ratio) was between 0.80 and 1.25, and the upper one-sided 95% confidence interval (CI) for the scaled average bioequivalence metric was ≤ 0 (-0.08). AUC of ASA as SD W  was < 0.294 for log-transformed AUC last  and AUC. Estimates of 90% CIs for log-transformed AUC last  and AUC ratios were within the bioequivalence range of 0.80 to 1.25 (0.98-1.08 and 1.00-1.10, respectively). For clopidogrel, the 90% CIs for the ratios comparing log-transformed C max , AUC last , and AUC ratios of clopidogrel following administration of test versus reference formulation were calculated using the ABE method and were well within the acceptable range of 0.80 to 1.25 (1.02-1.12, 0.92-0.99, and 0.92-0.98, respectively).
CONCLUSION


FDC of ASA and clopidogrel was bioequivalent to the simultaneous administration of the individual formulations in healthy Chinese subjects under fed conditions.
TRIAL REGISTRATION


CTR20190376.",2020,AUC of ASA as SD W  was < 0.294 for log-transformed AUC,"['healthy Chinese subjects under fed conditions', 'acute coronary syndrome', 'healthy Chinese male and female subjects under fed conditions', 'Chinese Subjects Under Fed Conditions']","['Clopidogrel and Aspirin with Coadministration of Individual Formulations', 'combination tablet containing 75-mg clopidogrel and 100-mg enteric ASA (test formulation) or (2) coadministration of one 75-mg clopidogrel tablet and one 100-mg enteric-coated ASA tablet (reference formulations) under fed conditions', 'clopidogrel', 'Clopidogrel\u2009+\u2009ASA', 'AUC', 'acetylsalicylic acid (ASA) and clopidogrel']","['AUC ratios', 'ratios comparing log-transformed C max , AUC last , and AUC ratios of clopidogrel']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C1304890', 'cui_str': 'Enteral'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1248670', 'cui_str': 'clopidogrel Oral Tablet'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}]","[{'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}]",,0.234126,AUC of ASA as SD W  was < 0.294 for log-transformed AUC,"[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing, 100038, China.'}, {'ForeName': 'Jeffrey E', 'Initials': 'JE', 'LastName': 'Ming', 'Affiliation': 'Research and Development, Sanofi, New York, USA.'}, {'ForeName': 'Fangyuan', 'Initials': 'F', 'LastName': 'Kong', 'Affiliation': 'Research and Development, Sanofi, Beijing, China.'}, {'ForeName': 'Huiqiu', 'Initials': 'H', 'LastName': 'Yin', 'Affiliation': 'Medical, Sanofi, Shanghai, China.'}, {'ForeName': 'Linlin', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Medical, Sanofi, Beijing, China.'}, {'ForeName': 'Haihong', 'Initials': 'H', 'LastName': 'Bai', 'Affiliation': 'Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing, 100038, China.'}, {'ForeName': 'Huijuan', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing, 100038, China.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Qi', 'Affiliation': 'Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing, 100038, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Xie', 'Affiliation': 'Medical, Sanofi, Shanghai, China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Yang', 'Affiliation': 'Research and Development, Sanofi, Beijing, China.'}, {'ForeName': 'Chuan', 'Initials': 'C', 'LastName': 'Ping', 'Affiliation': 'Research and Development, Sanofi, Beijing, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Research and Development, Sanofi, Beijing, China.'}, {'ForeName': 'Liu', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing, 100038, China.'}, {'ForeName': 'Chunyu', 'Initials': 'C', 'LastName': 'Han', 'Affiliation': 'Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing, 100038, China.'}, {'ForeName': 'Ju', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing, 100038, China.'}, {'ForeName': 'Xinghe', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing, 100038, China. wangxh@bjsjth.cn.'}]",Advances in therapy,['10.1007/s12325-020-01486-9']
2845,32970396,Dapagliflozin in Patients with Chronic Kidney Disease.,"BACKGROUND


Patients with chronic kidney disease have a high risk of adverse kidney and cardiovascular outcomes. The effect of dapagliflozin in patients with chronic kidney disease, with or without type 2 diabetes, is not known.
METHODS


We randomly assigned 4304 participants with an estimated glomerular filtration rate (GFR) of 25 to 75 ml per minute per 1.73 m 2  of body-surface area and a urinary albumin-to-creatinine ratio (with albumin measured in milligrams and creatinine measured in grams) of 200 to 5000 to receive dapagliflozin (10 mg once daily) or placebo. The primary outcome was a composite of a sustained decline in the estimated GFR of at least 50%, end-stage kidney disease, or death from renal or cardiovascular causes.
RESULTS


The independent data monitoring committee recommended stopping the trial because of efficacy. Over a median of 2.4 years, a primary outcome event occurred in 197 of 2152 participants (9.2%) in the dapagliflozin group and 312 of 2152 participants (14.5%) in the placebo group (hazard ratio, 0.61; 95% confidence interval [CI], 0.51 to 0.72; P<0.001; number needed to treat to prevent one primary outcome event, 19 [95% CI, 15 to 27]). The hazard ratio for the composite of a sustained decline in the estimated GFR of at least 50%, end-stage kidney disease, or death from renal causes was 0.56 (95% CI, 0.45 to 0.68; P<0.001), and the hazard ratio for the composite of death from cardiovascular causes or hospitalization for heart failure was 0.71 (95% CI, 0.55 to 0.92; P = 0.009). Death occurred in 101 participants (4.7%) in the dapagliflozin group and 146 participants (6.8%) in the placebo group (hazard ratio, 0.69; 95% CI, 0.53 to 0.88; P = 0.004). The effects of dapagliflozin were similar in participants with type 2 diabetes and in those without type 2 diabetes. The known safety profile of dapagliflozin was confirmed.
CONCLUSIONS


Among patients with chronic kidney disease, regardless of the presence or absence of diabetes, the risk of a composite of a sustained decline in the estimated GFR of at least 50%, end-stage kidney disease, or death from renal or cardiovascular causes was significantly lower with dapagliflozin than with placebo. (Funded by AstraZeneca; DAPA-CKD ClinicalTrials.gov number, NCT03036150.).",2020,The effects of dapagliflozin were similar in participants with type 2 diabetes and in those without type 2 diabetes.,"['patients with chronic kidney disease, with or without type 2 diabetes', 'Patients with chronic kidney disease', 'participants with type 2 diabetes and in those without type 2 diabetes', 'patients with chronic kidney disease', '4304 participants with an estimated glomerular filtration rate (GFR) of 25 to 75 ml per minute per 1.73 m 2  of body-surface area and a', 'Patients with Chronic Kidney Disease']","['placebo', 'urinary albumin-to-creatinine ratio (with albumin measured in milligrams and creatinine measured in grams) of 200 to 5000 to receive dapagliflozin', 'Dapagliflozin', 'dapagliflozin']","['composite of a sustained decline in the estimated GFR of at least 50%, end-stage kidney disease, or death from renal or cardiovascular causes', 'stage kidney disease, or death from renal causes', 'hazard ratio for the composite of death from cardiovascular causes or hospitalization for heart failure', 'Death', 'death from renal or cardiovascular causes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0702093', 'cui_str': '/minute'}, {'cui': 'C0005902', 'cui_str': 'Body surface area'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439210', 'cui_str': 'mg'}, {'cui': 'C0439208', 'cui_str': 'g'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4319610', 'cui_str': '5000'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]",4304.0,0.730754,The effects of dapagliflozin were similar in participants with type 2 diabetes and in those without type 2 diabetes.,"[{'ForeName': 'Hiddo J L', 'Initials': 'HJL', 'LastName': 'Heerspink', 'Affiliation': 'From the Department Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands (H.J.L.H.); the George Institute for Global Health, Sydney (H.J.L.H., D.C.W.); Late-Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (B.V.S., M.L., C.D.S., A.-M.L.); the National Medical Science and Nutrition Institute Salvador Zubirán, Mexico City (R.C.-R.); the Departments of Medicine and Epidemiology and Population Health, Stanford University School of Medicine, Stanford, CA (G.M.C.); the Study Design and Biostatistics Center, University of Utah Health Sciences, Salt Lake City (T.G.); the Division of Nephrology, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, Guangzhou, China (F.-F.H.); KfH Kidney Center, Munich, and Department of Medicine 4, University of Erlangen-Nuremberg, Erlangen - both in Germany (J.F.E.M.); the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (J.J.V.M.), and the Department of Renal Medicine, University College London, London (D.C.W.) - both in the United Kingdom; Steno Diabetes Center Copenhagen, Gentofte, and the Department of Clinical Medicine, University of Copenhagen, Copenhagen - both in Denmark (P.R.); and the Department of Internal Medicine, UT Southwestern Medical Center, Dallas (R.D.T.).'}, {'ForeName': 'Bergur V', 'Initials': 'BV', 'LastName': 'Stefánsson', 'Affiliation': 'From the Department Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands (H.J.L.H.); the George Institute for Global Health, Sydney (H.J.L.H., D.C.W.); Late-Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (B.V.S., M.L., C.D.S., A.-M.L.); the National Medical Science and Nutrition Institute Salvador Zubirán, Mexico City (R.C.-R.); the Departments of Medicine and Epidemiology and Population Health, Stanford University School of Medicine, Stanford, CA (G.M.C.); the Study Design and Biostatistics Center, University of Utah Health Sciences, Salt Lake City (T.G.); the Division of Nephrology, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, Guangzhou, China (F.-F.H.); KfH Kidney Center, Munich, and Department of Medicine 4, University of Erlangen-Nuremberg, Erlangen - both in Germany (J.F.E.M.); the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (J.J.V.M.), and the Department of Renal Medicine, University College London, London (D.C.W.) - both in the United Kingdom; Steno Diabetes Center Copenhagen, Gentofte, and the Department of Clinical Medicine, University of Copenhagen, Copenhagen - both in Denmark (P.R.); and the Department of Internal Medicine, UT Southwestern Medical Center, Dallas (R.D.T.).'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Correa-Rotter', 'Affiliation': 'From the Department Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands (H.J.L.H.); the George Institute for Global Health, Sydney (H.J.L.H., D.C.W.); Late-Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (B.V.S., M.L., C.D.S., A.-M.L.); the National Medical Science and Nutrition Institute Salvador Zubirán, Mexico City (R.C.-R.); the Departments of Medicine and Epidemiology and Population Health, Stanford University School of Medicine, Stanford, CA (G.M.C.); the Study Design and Biostatistics Center, University of Utah Health Sciences, Salt Lake City (T.G.); the Division of Nephrology, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, Guangzhou, China (F.-F.H.); KfH Kidney Center, Munich, and Department of Medicine 4, University of Erlangen-Nuremberg, Erlangen - both in Germany (J.F.E.M.); the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (J.J.V.M.), and the Department of Renal Medicine, University College London, London (D.C.W.) - both in the United Kingdom; Steno Diabetes Center Copenhagen, Gentofte, and the Department of Clinical Medicine, University of Copenhagen, Copenhagen - both in Denmark (P.R.); and the Department of Internal Medicine, UT Southwestern Medical Center, Dallas (R.D.T.).'}, {'ForeName': 'Glenn M', 'Initials': 'GM', 'LastName': 'Chertow', 'Affiliation': 'From the Department Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands (H.J.L.H.); the George Institute for Global Health, Sydney (H.J.L.H., D.C.W.); Late-Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (B.V.S., M.L., C.D.S., A.-M.L.); the National Medical Science and Nutrition Institute Salvador Zubirán, Mexico City (R.C.-R.); the Departments of Medicine and Epidemiology and Population Health, Stanford University School of Medicine, Stanford, CA (G.M.C.); the Study Design and Biostatistics Center, University of Utah Health Sciences, Salt Lake City (T.G.); the Division of Nephrology, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, Guangzhou, China (F.-F.H.); KfH Kidney Center, Munich, and Department of Medicine 4, University of Erlangen-Nuremberg, Erlangen - both in Germany (J.F.E.M.); the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (J.J.V.M.), and the Department of Renal Medicine, University College London, London (D.C.W.) - both in the United Kingdom; Steno Diabetes Center Copenhagen, Gentofte, and the Department of Clinical Medicine, University of Copenhagen, Copenhagen - both in Denmark (P.R.); and the Department of Internal Medicine, UT Southwestern Medical Center, Dallas (R.D.T.).'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Greene', 'Affiliation': 'From the Department Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands (H.J.L.H.); the George Institute for Global Health, Sydney (H.J.L.H., D.C.W.); Late-Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (B.V.S., M.L., C.D.S., A.-M.L.); the National Medical Science and Nutrition Institute Salvador Zubirán, Mexico City (R.C.-R.); the Departments of Medicine and Epidemiology and Population Health, Stanford University School of Medicine, Stanford, CA (G.M.C.); the Study Design and Biostatistics Center, University of Utah Health Sciences, Salt Lake City (T.G.); the Division of Nephrology, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, Guangzhou, China (F.-F.H.); KfH Kidney Center, Munich, and Department of Medicine 4, University of Erlangen-Nuremberg, Erlangen - both in Germany (J.F.E.M.); the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (J.J.V.M.), and the Department of Renal Medicine, University College London, London (D.C.W.) - both in the United Kingdom; Steno Diabetes Center Copenhagen, Gentofte, and the Department of Clinical Medicine, University of Copenhagen, Copenhagen - both in Denmark (P.R.); and the Department of Internal Medicine, UT Southwestern Medical Center, Dallas (R.D.T.).'}, {'ForeName': 'Fan-Fan', 'Initials': 'FF', 'LastName': 'Hou', 'Affiliation': 'From the Department Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands (H.J.L.H.); the George Institute for Global Health, Sydney (H.J.L.H., D.C.W.); Late-Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (B.V.S., M.L., C.D.S., A.-M.L.); the National Medical Science and Nutrition Institute Salvador Zubirán, Mexico City (R.C.-R.); the Departments of Medicine and Epidemiology and Population Health, Stanford University School of Medicine, Stanford, CA (G.M.C.); the Study Design and Biostatistics Center, University of Utah Health Sciences, Salt Lake City (T.G.); the Division of Nephrology, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, Guangzhou, China (F.-F.H.); KfH Kidney Center, Munich, and Department of Medicine 4, University of Erlangen-Nuremberg, Erlangen - both in Germany (J.F.E.M.); the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (J.J.V.M.), and the Department of Renal Medicine, University College London, London (D.C.W.) - both in the United Kingdom; Steno Diabetes Center Copenhagen, Gentofte, and the Department of Clinical Medicine, University of Copenhagen, Copenhagen - both in Denmark (P.R.); and the Department of Internal Medicine, UT Southwestern Medical Center, Dallas (R.D.T.).'}, {'ForeName': 'Johannes F E', 'Initials': 'JFE', 'LastName': 'Mann', 'Affiliation': 'From the Department Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands (H.J.L.H.); the George Institute for Global Health, Sydney (H.J.L.H., D.C.W.); Late-Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (B.V.S., M.L., C.D.S., A.-M.L.); the National Medical Science and Nutrition Institute Salvador Zubirán, Mexico City (R.C.-R.); the Departments of Medicine and Epidemiology and Population Health, Stanford University School of Medicine, Stanford, CA (G.M.C.); the Study Design and Biostatistics Center, University of Utah Health Sciences, Salt Lake City (T.G.); the Division of Nephrology, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, Guangzhou, China (F.-F.H.); KfH Kidney Center, Munich, and Department of Medicine 4, University of Erlangen-Nuremberg, Erlangen - both in Germany (J.F.E.M.); the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (J.J.V.M.), and the Department of Renal Medicine, University College London, London (D.C.W.) - both in the United Kingdom; Steno Diabetes Center Copenhagen, Gentofte, and the Department of Clinical Medicine, University of Copenhagen, Copenhagen - both in Denmark (P.R.); and the Department of Internal Medicine, UT Southwestern Medical Center, Dallas (R.D.T.).'}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'From the Department Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands (H.J.L.H.); the George Institute for Global Health, Sydney (H.J.L.H., D.C.W.); Late-Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (B.V.S., M.L., C.D.S., A.-M.L.); the National Medical Science and Nutrition Institute Salvador Zubirán, Mexico City (R.C.-R.); the Departments of Medicine and Epidemiology and Population Health, Stanford University School of Medicine, Stanford, CA (G.M.C.); the Study Design and Biostatistics Center, University of Utah Health Sciences, Salt Lake City (T.G.); the Division of Nephrology, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, Guangzhou, China (F.-F.H.); KfH Kidney Center, Munich, and Department of Medicine 4, University of Erlangen-Nuremberg, Erlangen - both in Germany (J.F.E.M.); the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (J.J.V.M.), and the Department of Renal Medicine, University College London, London (D.C.W.) - both in the United Kingdom; Steno Diabetes Center Copenhagen, Gentofte, and the Department of Clinical Medicine, University of Copenhagen, Copenhagen - both in Denmark (P.R.); and the Department of Internal Medicine, UT Southwestern Medical Center, Dallas (R.D.T.).'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Lindberg', 'Affiliation': 'From the Department Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands (H.J.L.H.); the George Institute for Global Health, Sydney (H.J.L.H., D.C.W.); Late-Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (B.V.S., M.L., C.D.S., A.-M.L.); the National Medical Science and Nutrition Institute Salvador Zubirán, Mexico City (R.C.-R.); the Departments of Medicine and Epidemiology and Population Health, Stanford University School of Medicine, Stanford, CA (G.M.C.); the Study Design and Biostatistics Center, University of Utah Health Sciences, Salt Lake City (T.G.); the Division of Nephrology, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, Guangzhou, China (F.-F.H.); KfH Kidney Center, Munich, and Department of Medicine 4, University of Erlangen-Nuremberg, Erlangen - both in Germany (J.F.E.M.); the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (J.J.V.M.), and the Department of Renal Medicine, University College London, London (D.C.W.) - both in the United Kingdom; Steno Diabetes Center Copenhagen, Gentofte, and the Department of Clinical Medicine, University of Copenhagen, Copenhagen - both in Denmark (P.R.); and the Department of Internal Medicine, UT Southwestern Medical Center, Dallas (R.D.T.).'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Rossing', 'Affiliation': 'From the Department Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands (H.J.L.H.); the George Institute for Global Health, Sydney (H.J.L.H., D.C.W.); Late-Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (B.V.S., M.L., C.D.S., A.-M.L.); the National Medical Science and Nutrition Institute Salvador Zubirán, Mexico City (R.C.-R.); the Departments of Medicine and Epidemiology and Population Health, Stanford University School of Medicine, Stanford, CA (G.M.C.); the Study Design and Biostatistics Center, University of Utah Health Sciences, Salt Lake City (T.G.); the Division of Nephrology, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, Guangzhou, China (F.-F.H.); KfH Kidney Center, Munich, and Department of Medicine 4, University of Erlangen-Nuremberg, Erlangen - both in Germany (J.F.E.M.); the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (J.J.V.M.), and the Department of Renal Medicine, University College London, London (D.C.W.) - both in the United Kingdom; Steno Diabetes Center Copenhagen, Gentofte, and the Department of Clinical Medicine, University of Copenhagen, Copenhagen - both in Denmark (P.R.); and the Department of Internal Medicine, UT Southwestern Medical Center, Dallas (R.D.T.).'}, {'ForeName': 'C David', 'Initials': 'CD', 'LastName': 'Sjöström', 'Affiliation': 'From the Department Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands (H.J.L.H.); the George Institute for Global Health, Sydney (H.J.L.H., D.C.W.); Late-Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (B.V.S., M.L., C.D.S., A.-M.L.); the National Medical Science and Nutrition Institute Salvador Zubirán, Mexico City (R.C.-R.); the Departments of Medicine and Epidemiology and Population Health, Stanford University School of Medicine, Stanford, CA (G.M.C.); the Study Design and Biostatistics Center, University of Utah Health Sciences, Salt Lake City (T.G.); the Division of Nephrology, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, Guangzhou, China (F.-F.H.); KfH Kidney Center, Munich, and Department of Medicine 4, University of Erlangen-Nuremberg, Erlangen - both in Germany (J.F.E.M.); the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (J.J.V.M.), and the Department of Renal Medicine, University College London, London (D.C.W.) - both in the United Kingdom; Steno Diabetes Center Copenhagen, Gentofte, and the Department of Clinical Medicine, University of Copenhagen, Copenhagen - both in Denmark (P.R.); and the Department of Internal Medicine, UT Southwestern Medical Center, Dallas (R.D.T.).'}, {'ForeName': 'Roberto D', 'Initials': 'RD', 'LastName': 'Toto', 'Affiliation': 'From the Department Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands (H.J.L.H.); the George Institute for Global Health, Sydney (H.J.L.H., D.C.W.); Late-Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (B.V.S., M.L., C.D.S., A.-M.L.); the National Medical Science and Nutrition Institute Salvador Zubirán, Mexico City (R.C.-R.); the Departments of Medicine and Epidemiology and Population Health, Stanford University School of Medicine, Stanford, CA (G.M.C.); the Study Design and Biostatistics Center, University of Utah Health Sciences, Salt Lake City (T.G.); the Division of Nephrology, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, Guangzhou, China (F.-F.H.); KfH Kidney Center, Munich, and Department of Medicine 4, University of Erlangen-Nuremberg, Erlangen - both in Germany (J.F.E.M.); the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (J.J.V.M.), and the Department of Renal Medicine, University College London, London (D.C.W.) - both in the United Kingdom; Steno Diabetes Center Copenhagen, Gentofte, and the Department of Clinical Medicine, University of Copenhagen, Copenhagen - both in Denmark (P.R.); and the Department of Internal Medicine, UT Southwestern Medical Center, Dallas (R.D.T.).'}, {'ForeName': 'Anna-Maria', 'Initials': 'AM', 'LastName': 'Langkilde', 'Affiliation': 'From the Department Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands (H.J.L.H.); the George Institute for Global Health, Sydney (H.J.L.H., D.C.W.); Late-Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (B.V.S., M.L., C.D.S., A.-M.L.); the National Medical Science and Nutrition Institute Salvador Zubirán, Mexico City (R.C.-R.); the Departments of Medicine and Epidemiology and Population Health, Stanford University School of Medicine, Stanford, CA (G.M.C.); the Study Design and Biostatistics Center, University of Utah Health Sciences, Salt Lake City (T.G.); the Division of Nephrology, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, Guangzhou, China (F.-F.H.); KfH Kidney Center, Munich, and Department of Medicine 4, University of Erlangen-Nuremberg, Erlangen - both in Germany (J.F.E.M.); the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (J.J.V.M.), and the Department of Renal Medicine, University College London, London (D.C.W.) - both in the United Kingdom; Steno Diabetes Center Copenhagen, Gentofte, and the Department of Clinical Medicine, University of Copenhagen, Copenhagen - both in Denmark (P.R.); and the Department of Internal Medicine, UT Southwestern Medical Center, Dallas (R.D.T.).'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Wheeler', 'Affiliation': 'From the Department Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands (H.J.L.H.); the George Institute for Global Health, Sydney (H.J.L.H., D.C.W.); Late-Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (B.V.S., M.L., C.D.S., A.-M.L.); the National Medical Science and Nutrition Institute Salvador Zubirán, Mexico City (R.C.-R.); the Departments of Medicine and Epidemiology and Population Health, Stanford University School of Medicine, Stanford, CA (G.M.C.); the Study Design and Biostatistics Center, University of Utah Health Sciences, Salt Lake City (T.G.); the Division of Nephrology, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, Guangzhou, China (F.-F.H.); KfH Kidney Center, Munich, and Department of Medicine 4, University of Erlangen-Nuremberg, Erlangen - both in Germany (J.F.E.M.); the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (J.J.V.M.), and the Department of Renal Medicine, University College London, London (D.C.W.) - both in the United Kingdom; Steno Diabetes Center Copenhagen, Gentofte, and the Department of Clinical Medicine, University of Copenhagen, Copenhagen - both in Denmark (P.R.); and the Department of Internal Medicine, UT Southwestern Medical Center, Dallas (R.D.T.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2024816']
2846,32966959,Within-person networks of clinical features of social anxiety disorder during cognitive and interpersonal therapy.,"Analysis of longitudinal within-person networks over the course of therapy allows an identification of possible targets of treatment. This study examined within-person networks of clinical features in social anxiety disorder (SAD) patients during cognitive (CT) and interpersonal (IPT) therapy. Patients (n = 80) were randomized to either CT or IPT in a 10 week residential program. They completed a measure of clinical features two times a week. The 60 (75 %) patients who had completed at least 18 measurements were included in the analyses. The multilevel vector autoregressive (mlVAR) model was used to analyze the data, producing a temporal, contemporaneous, and between-person network. In the temporal network and as expected, more homework compliance in a half-week predicted less social anxiety and less social avoidance the subsequent half-week. Also better social function predicted less social avoidance, whereas more social anxiety predicted more self-focus. Unexpectedly, less social avoidance predicted more self-focus and less self-focus predicted less social function and social joy. In the contemporaneous network, self-focus, anxiety and avoidance displayed a conditional independence structure. The estimated temporal network suggests that homework compliance and social function are promising targets of treatment.",2020,"Also better social function predicted less social avoidance, whereas more social anxiety predicted more self-focus.","['social anxiety disorder (SAD) patients during cognitive (CT) and interpersonal (IPT) therapy', 'The 60 (75 %) patients who had completed at least 18 measurements were included in the analyses', 'Patients (n = 80']","['cognitive and interpersonal therapy', 'CT or IPT']","['social function and social joy', 'social anxiety', 'social avoidance', 'homework compliance']","[{'cui': 'C0031572', 'cui_str': 'Social phobia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0380193', 'cui_str': 'iodine-123-IPT'}]","[{'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C0589414', 'cui_str': 'Homework'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}]",80.0,0.0147056,"Also better social function predicted less social avoidance, whereas more social anxiety predicted more self-focus.","[{'ForeName': 'Asle', 'Initials': 'A', 'LastName': 'Hoffart', 'Affiliation': 'Research Institute, Modum Bad Psychiatric Center, Badeveien 287, N-3370, Vikersund, Norway; Department of Psychology, University of Oslo, PB 1094, Blindern, N-0317, Oslo, Norway. Electronic address: asle.hoffart@modum-bad.no.'}, {'ForeName': 'Sverre Urnes', 'Initials': 'SU', 'LastName': 'Johnson', 'Affiliation': 'Research Institute, Modum Bad Psychiatric Center, Badeveien 287, N-3370, Vikersund, Norway; Department of Psychology, University of Oslo, PB 1094, Blindern, N-0317, Oslo, Norway. Electronic address: Sverre.Johnson@modum-bad.no.'}]",Journal of anxiety disorders,['10.1016/j.janxdis.2020.102312']
2847,32967068,Effect of Vitamin D Supplement on Vulvovaginal Atrophy of the Menopause.,"The effects of oral vitamin D supplements on vaginal health in postmenopausal women with vulvovaginal atrophy (VVA) was evaluated. A double-blinded, randomized placebo-controlled trial was conducted for 12 weeks to investigate changes on vaginal maturation index (VMI), vaginal pH, and the visual analog scale (VAS) of VVA symptoms. The vitamin D group received oral ergocalciferol, at 40,000 IU per week, while the placebo group received an identical placebo capsule. Eighty postmenopausal women were enrolled. There were no significant differences in baseline characteristics between both groups. In an intention-to-treat analysis, VMI, vaginal pH, and VAS of VVA symptoms showed no significant differences between both groups at the six and 12 weeks. However, the mean difference of VMI in the vitamin D group between baseline and at six weeks showed significant improvement (5.5 + 16.27,  p  <0.05). Moreover, the mean vaginal pH and VAS of VVA patients in the vitamin D group were significantly improved at both six and 12 weeks compared to baseline. The oral vitamin D supplementation for 12 weeks potentially improves vaginal health outcomes in postmenopausal women with VVA symptoms, demonstrated by the improved mean VMI, vaginal pH, and VAS at six and 12 weeks between baseline, however, no significant differences were observed from the placebo treatment.",2020,"Moreover, the mean vaginal pH and VAS of VVA patients in the vitamin D group were significantly improved at both six and 12 weeks compared to baseline.","['Eighty postmenopausal women were enrolled', 'postmenopausal women with vulvovaginal atrophy (VVA', 'postmenopausal women with VVA symptoms']","['oral ergocalciferol', 'Vitamin D Supplement', 'vitamin D', 'oral vitamin D supplements', 'placebo capsule', 'placebo', 'oral vitamin D supplementation']","['VMI, vaginal pH, and VAS of VVA symptoms', 'vaginal health', 'Vulvovaginal Atrophy of the Menopause', 'mean VMI, vaginal pH, and VAS', 'vaginal health outcomes', 'VMI', 'mean vaginal pH and VAS', 'vaginal maturation index (VMI), vaginal pH, and the visual analog scale (VAS) of VVA symptoms']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0857741', 'cui_str': 'Vulvovaginal atrophy'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0014695', 'cui_str': 'Ergocalciferol'}, {'cui': 'C0420176', 'cui_str': 'Vitamin D supplement therapy'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}]","[{'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0429263', 'cui_str': 'Vaginal pH'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0857741', 'cui_str': 'Vulvovaginal atrophy'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",80.0,0.39508,"Moreover, the mean vaginal pH and VAS of VVA patients in the vitamin D group were significantly improved at both six and 12 weeks compared to baseline.","[{'ForeName': 'Thawinee', 'Initials': 'T', 'LastName': 'Kamronrithisorn', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok 10400, Thailand.'}, {'ForeName': 'Jittima', 'Initials': 'J', 'LastName': 'Manonai', 'Affiliation': 'Female Pelvic Medicine and Reconstructive Surgery Unit, Department of Obstetrics & Gynaecology, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok 10400, Thailand.'}, {'ForeName': 'Sakda Arj-Ong', 'Initials': 'SA', 'LastName': 'Vallibhakara', 'Affiliation': 'ASEAN Institute for Health Development, Mahidol University, Nakhon Pathom 73170, Thailand.'}, {'ForeName': 'Areepan', 'Initials': 'A', 'LastName': 'Sophonsritsuk', 'Affiliation': 'Reproductive Endocrinology and Infertility Unit, Department of Obstetrics and Gynaecology, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok 10400, Thailand.'}, {'ForeName': 'Orawin', 'Initials': 'O', 'LastName': 'Vallibhakara', 'Affiliation': 'Reproductive Endocrinology and Infertility Unit, Department of Obstetrics and Gynaecology, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok 10400, Thailand.'}]",Nutrients,['10.3390/nu12092876']
2848,32967132,Vitamin D Correction Down-Regulates Serum Amyloid P Component Levels in Vitamin D Deficient Arab Adults: A Single-Arm Trial.,"Vitamin D (VD) has been observed to have anti-inflammatory properties. However, the effects of VD supplementation on the serum amyloid P component (SAP) has not been established. This study aimed to investigate the effect of VD supplementation on serum SAP levels in Arab adults. A total of 155 VD-deficient adult Saudis (56 males and 99 females) were recruited in this non-randomized, 6-month, single-arm trial. The intervention was as follows; cholecalciferol 50,000 international units (IU) every week for the first 2 months, followed by 50,000 twice a month for the next two months, and for the last two months, 1000 IU daily. Serum 25(OH)D, SAP, C-reactive protein (CRP), lipid profile, and glucose were assessed at baseline and post-intervention. At post-intervention, VD levels were significantly increased, while SAP levels significantly decreased in all study participants. Remarkably, this reduction in SAP was more significant in males than females after stratification. SAP was inversely correlated with VD overall (r = -0.17,  p  < 0.05), and only in males (r = -0.27,  p  < 0.05) after stratification according to sex after 6 months of VD supplementation. Such a relationship was not observed at baseline. VD supplementation can favorably modulate serum SAP concentrations in Arab adults, particularly in males.",2020,"At post-intervention, VD levels were significantly increased, while SAP levels significantly decreased in all study participants.","['A total of 155 VD-deficient adult Saudis (56 males and 99 females', 'Vitamin D Deficient Arab Adults', 'Arab adults, particularly in males', 'Arab adults']","['VD supplementation', 'Vitamin D Correction Down', 'Vitamin D (VD', 'cholecalciferol']","['SAP', 'serum SAP levels', 'VD levels', 'SAP levels', 'serum SAP concentrations', 'Serum 25(OH)D, SAP, C-reactive protein (CRP), lipid profile, and glucose']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0282540', 'cui_str': 'Arabs'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}]","[{'cui': 'C0002721', 'cui_str': 'Amyloid P component'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}]",,0.0318965,"At post-intervention, VD levels were significantly increased, while SAP levels significantly decreased in all study participants.","[{'ForeName': 'Osama E', 'Initials': 'OE', 'LastName': 'Amer', 'Affiliation': 'Chair for Biomarkers of Chronic Diseases, Biochemistry Department, College of Science, King Saud University, Riyadh 11451, Saudi Arabia.'}, {'ForeName': 'Malak N K', 'Initials': 'MNK', 'LastName': 'Khattak', 'Affiliation': 'Chair for Biomarkers of Chronic Diseases, Biochemistry Department, College of Science, King Saud University, Riyadh 11451, Saudi Arabia.'}, {'ForeName': 'Abdullah M', 'Initials': 'AM', 'LastName': 'Alnaami', 'Affiliation': 'Chair for Biomarkers of Chronic Diseases, Biochemistry Department, College of Science, King Saud University, Riyadh 11451, Saudi Arabia.'}, {'ForeName': 'Naji J', 'Initials': 'NJ', 'LastName': 'Aljohani', 'Affiliation': 'Specialized Diabetes and Endocrine Center, King Fahad Medical City, Riyadh 11525, Saudi Arabia.'}, {'ForeName': 'Nasser M', 'Initials': 'NM', 'LastName': 'Al-Daghri', 'Affiliation': 'Chair for Biomarkers of Chronic Diseases, Biochemistry Department, College of Science, King Saud University, Riyadh 11451, Saudi Arabia.'}]",Nutrients,['10.3390/nu12092880']
2849,32967151,"Effects of  Tetraselmis chuii  Microalgae Supplementation on Ergospirometric, Haematological and Biochemical Parameters in Amateur Soccer Players.","This study aimed to analyse the effects of  Tetraselmis chuii  (TC) microalgae supplementation during thirty days on ergospirometric, haematological and biochemical parameters in amateur soccer players. Thirty-two amateur soccer players divided into a control group (CG;  n  = 16; 22.36 ± 1.36 years; 68.36 ± 3.53 kg) and a supplemented group (SG;  n  = 16; 22.23 ± 2.19 years; 69.30 ± 5.56 kg) participated in the double-blind study. SG ingested 200 mg of the TC per day, while CG ingested 200 mg per day of lactose powder. Supplementation was carried out for thirty days. The participants performed a maximal treadmill test until exhaustion. The ergospirometric values at different ventilatory thresholds and haematological values were obtained after the test. Heart rate decreased after supplementation with TC ( p  < 0.05). Oxygen pulse, relative and absolute maximum oxygen consumption increased in SG (pre vs. post; 19.04 ± 2.53 vs. 22.08 ± 2.25; 53.56 ± 3.26 vs. 56.74 ± 3.43; 3.72 ± 0.35 vs. 3.99 ± 0.25;  p  < 0.05). Haemoglobin and mean corpuscular haemoglobin increased in SG (pre vs. post; 15.12 ± 0.87 vs. 16.58 ± 0.74  p  < 0.01; 28.03 ± 1.57 vs. 30.82 ± 1.21;  p  < 0.05). On the other hand, haematocrit and mean platelet volume decreased in SG ( p  < 0.05). TC supplementation elicited improvements in ergospirometric and haematological values in amateur soccer players. TC supplementation could be valuable for improving performance in amateur athletes.",2020,Haemoglobin and mean corpuscular haemoglobin increased in SG (pre vs. post; 15.12 ± 0.87 vs. 16.58 ± 0.74  p  < 0.01; 28.03 ± 1.57 vs. 30.82 ± 1.21;  p  < 0.05).,"['Amateur Soccer Players', 'amateur athletes', 'Thirty-two amateur soccer players divided into a control group (CG;  n  = 16; 22.36 ± 1.36 years; 68.36 ± 3.53 kg) and a supplemented group (SG;  n  = 16; 22.23 ± 2.19 years; 69.30 ± 5.56 kg) participated in the double-blind study', 'amateur soccer players']","['Tetraselmis chuii  (TC) microalgae supplementation', 'TC supplementation', 'Tetraselmis chuii  Microalgae Supplementation']","['Oxygen pulse, relative and absolute maximum oxygen consumption', 'haematocrit and mean platelet volume', 'Heart rate', 'Haemoglobin and mean corpuscular haemoglobin', 'Ergospirometric, Haematological and Biochemical Parameters', 'ergospirometric and haematological values']","[{'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4708912', 'cui_str': '1.36'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517793', 'cui_str': '5.56'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}]","[{'cui': 'C2936330', 'cui_str': 'Microphytes'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0200665', 'cui_str': 'Platelet mean volume determination'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0369183', 'cui_str': 'Mean corpuscular hemoglobin determination'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.0954851,Haemoglobin and mean corpuscular haemoglobin increased in SG (pre vs. post; 15.12 ± 0.87 vs. 16.58 ± 0.74  p  < 0.01; 28.03 ± 1.57 vs. 30.82 ± 1.21;  p  < 0.05).,"[{'ForeName': 'Víctor', 'Initials': 'V', 'LastName': 'Toro', 'Affiliation': 'Department of Physiology, School of Sport Sciences, University of Extremadura, University Avenue, s/n CP: 10003 Cáceres, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Siquier-Coll', 'Affiliation': 'Department of Physiology, School of Sport Sciences, University of Extremadura, University Avenue, s/n CP: 10003 Cáceres, Spain.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Bartolomé', 'Affiliation': 'Department of Physiology, School of Sport Sciences, University of Extremadura, University Avenue, s/n CP: 10003 Cáceres, Spain.'}, {'ForeName': 'María C', 'Initials': 'MC', 'LastName': 'Robles-Gil', 'Affiliation': 'Department of Didactics of Musical, Plastic and Corporal Expression, School of Teacher Training, University of Extremadura, University Avenue, s/n CP: 10003 Cáceres, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Rodrigo', 'Affiliation': 'Department of Physiology, School of Sport Sciences, University of Extremadura, University Avenue, s/n CP: 10003 Cáceres, Spain.'}, {'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'Maynar-Mariño', 'Affiliation': 'Department of Physiology, School of Sport Sciences, University of Extremadura, University Avenue, s/n CP: 10003 Cáceres, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17186885']
2850,32967439,The Heart Failure Readmission Intervention by Variable Early Follow-up (THRIVE) Study: A Pragmatic Randomized Trial.,"BACKGROUND


In-person clinic follow-up within 7 days after discharge from a heart failure hospitalization is associated with lower 30-day readmission. However, health systems and patients may find it difficult to complete an early postdischarge clinic visit, especially during the current pandemic. We evaluated the effect on 30-day readmission and death of follow-up within 7 days postdischarge guided by an initial structured nonphysician telephone visit compared with follow-up guided by an initial clinic visit with a physician.
METHODS AND RESULTS


We conducted a pragmatic randomized trial in a large integrated healthcare delivery system. Adults being discharged home after hospitalization for heart failure were randomly assigned to either an initial telephone visit with a nurse or pharmacist to guide follow-up or an initial in-person clinic appointment with primary care physicians providing usual care within the first 7 days postdischarge. Telephone appointments included a structured protocol enabling medication titration, laboratory ordering, and booking urgent clinic visits as needed under physician supervision. Outcomes included 30-day readmissions and death and frequency and type of completed follow-up within 7 days of discharge. Among 2091 participants (mean age 78 years, 44% women), there were no significant differences in 30-day heart failure readmission (8.6% telephone, 10.6% clinic,  P =0.11), all-cause readmission (18.8% telephone, 20.6% clinic,  P =0.30), and all-cause death (4.0% telephone, 4.6% clinic,  P =0.49). Completed 7-day follow-up was higher in 1027 patients randomized to telephone follow-up (92%) compared with 1064 patients assigned to physician clinic follow-up (79%,  P <0.001). Overall frequency of clinic visits during the first 7 days postdischarge was lower in participants assigned to nonphysician telephone guided follow-up (48%) compared with physician clinic-guided follow-up (77%,  P <0.001).
CONCLUSIONS


Early, structured telephone follow-up after hospitalization for heart failure can increase 7-day follow-up and reduce in-person visits with comparable 30-day clinical outcomes within an integrated care delivery framework. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03524534.",2020,"Completed 7-day follow-up was higher in 1027 patients randomized to telephone follow-up (92%) compared with 1064 patients assigned to physician clinic follow-up (79%,  P <0.001).","['Adults being discharged home after hospitalization for heart failure', '2091 participants (mean age 78 years, 44% women']","['initial telephone visit with a nurse or pharmacist to guide follow-up or an initial in-person clinic appointment with primary care physicians providing usual care within the first 7 days postdischarge', 'initial structured nonphysician telephone visit compared with follow-up guided by an initial clinic visit with a physician']","['30-day readmission and death', 'cause readmission', 'Overall frequency of clinic visits', '30-day heart failure readmission', '30-day readmissions and death and frequency and type of completed follow-up within 7 days of discharge', 'Heart Failure Readmission Intervention']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0033131', 'cui_str': 'Primary care physician'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}, {'cui': 'C0031831', 'cui_str': 'Physician'}]","[{'cui': 'C0030700', 'cui_str': 'Thirty Day Readmission'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",2091.0,0.134487,"Completed 7-day follow-up was higher in 1027 patients randomized to telephone follow-up (92%) compared with 1064 patients assigned to physician clinic follow-up (79%,  P <0.001).","[{'ForeName': 'Keane K', 'Initials': 'KK', 'LastName': 'Lee', 'Affiliation': 'Department of Cardiology, Kaiser Permanente Santa Clara Medical Center, CA (K.K.L., A.S.).'}, {'ForeName': 'Rachel C', 'Initials': 'RC', 'LastName': 'Thomas', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, CA (K.K.L., R.C.T., T.C.T., T.K.L., A.S.G.).'}, {'ForeName': 'Thida C', 'Initials': 'TC', 'LastName': 'Tan', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, CA (K.K.L., R.C.T., T.C.T., T.K.L., A.S.G.).'}, {'ForeName': 'Thomas K', 'Initials': 'TK', 'LastName': 'Leong', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, CA (K.K.L., R.C.T., T.C.T., T.K.L., A.S.G.).'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Steimle', 'Affiliation': 'Department of Cardiology, Kaiser Permanente Santa Clara Medical Center, CA (K.K.L., A.S.).'}, {'ForeName': 'Alan S', 'Initials': 'AS', 'LastName': 'Go', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, CA (K.K.L., R.C.T., T.C.T., T.K.L., A.S.G.).'}]",Circulation. Cardiovascular quality and outcomes,['10.1161/CIRCOUTCOMES.120.006553']
2851,32967576,Effects of a Feedback-Demanding Stroke Clock on Acute Stroke Management: A Randomized Study.,"BACKGROUND AND PURPOSE


This randomized study aimed to evaluate whether the use of a stroke clock demanding active feedback from the stroke physician accelerates acute stroke management.
METHODS


For this randomized controlled study, a large-display alarm clock was installed in the computed tomography room, where admission, diagnostic work-up, and intravenous thrombolysis occurred. Alarms were set at the following target times after admission: (1) 15 minutes (neurological examination completed); (2) 25 minutes (computed tomography scanning and international normalized ratio determination by point-of-care laboratory completed); and (3) 30 minutes (intravenous thrombolysis started). The responsible stroke physician had to actively provide feedback by pressing a buzzer button. The alarm could be avoided by pressing the button before time out. Times to therapy decision (primary end point, defined as the end of all diagnostic work-up required for decision for or against recanalizing treatment), neurological examination, imaging, point-of-care laboratory, needle, and groin puncture were assessed by a neutral observer. Functional outcome (modified Rankin Scale) was assessed at day 90.
RESULTS


Of 107 participants, 51 stroke clock patients exhibited better stroke-management metrics than 56 control patients. Times from door to (1) end of all indicated diagnostic work-up (treatment decision time; 16.73 versus 26.00 minutes,  P <0.001), (2) end of neurological examination (7.28 versus 10.00 minutes,  P <0.001), (3) end of computed tomography (11.17 versus 14.00 minutes,  P =0.002), (4) end of computed tomography angiography (14.00 versus 17.17 minutes,  P =0.001), (5) end of point-of-care laboratory testing (12.14 versus 20.00 minutes,  P <0.001), and (6) needle times (18.83 versus 47.00 minutes,  P =0.016) were improved. In contrast, door-to-groin puncture times and functional outcomes at day 90 were not significantly different.
CONCLUSIONS


This study showed that the use of a stroke clock demanding active feedback significantly improves acute stroke-management metrics and, thus, represents a potential low-cost strategy for streamlining time-sensitive stroke treatment.",2020,"In contrast, door-to-groin puncture times and functional outcomes at day 90 were not significantly different.
","['107 participants, 51 stroke clock patients', 'Acute Stroke Management']",['Feedback-Demanding Stroke Clock'],"['Functional outcome (modified Rankin Scale', 'stroke-management metrics', 'acute stroke-management metrics', 'neurological examination', 'diagnostic work-up required for decision for or against recanalizing treatment), neurological examination, imaging, point-of-care laboratory, needle, and groin puncture']","[{'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0751956', 'cui_str': 'Acute stroke'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0751956', 'cui_str': 'Acute stroke'}, {'cui': 'C0027853', 'cui_str': 'Neurological examination'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0282664', 'cui_str': 'Point-of-Care'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0018246', 'cui_str': 'Inguinal'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}]",107.0,0.0644424,"In contrast, door-to-groin puncture times and functional outcomes at day 90 were not significantly different.
","[{'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Fousse', 'Affiliation': 'Department of Neurology (M.F., D.G., S.A.H., S. Walter, M.L., M.B., K.F.), Saarland University Medical Center, Homburg, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Grün', 'Affiliation': 'Department of Neurology (M.F., D.G., S.A.H., S. Walter, M.L., M.B., K.F.), Saarland University Medical Center, Homburg, Germany.'}, {'ForeName': 'Stefan A', 'Initials': 'SA', 'LastName': 'Helwig', 'Affiliation': 'Department of Neurology (M.F., D.G., S.A.H., S. Walter, M.L., M.B., K.F.), Saarland University Medical Center, Homburg, Germany.'}, {'ForeName': 'Silke', 'Initials': 'S', 'LastName': 'Walter', 'Affiliation': 'Department of Neurology (M.F., D.G., S.A.H., S. Walter, M.L., M.B., K.F.), Saarland University Medical Center, Homburg, Germany.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Bekhit', 'Affiliation': 'Institute of Medical Biometry, Epidemiology, and Medical Informatics (A.B., S. Wagenpfeil), Saarland University Medical Center, Homburg, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Wagenpfeil', 'Affiliation': 'Institute of Medical Biometry, Epidemiology, and Medical Informatics (A.B., S. Wagenpfeil), Saarland University Medical Center, Homburg, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Lesmeister', 'Affiliation': 'Department of Neurology (M.F., D.G., S.A.H., S. Walter, M.L., M.B., K.F.), Saarland University Medical Center, Homburg, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kettner', 'Affiliation': 'Department of Neuroradiology (M.K., S.R., R.M.-B., A.S., U.Y., W.R.), Saarland University Medical Center, Homburg, Germany.'}, {'ForeName': 'Safwan', 'Initials': 'S', 'LastName': 'Roumia', 'Affiliation': 'Department of Neuroradiology (M.K., S.R., R.M.-B., A.S., U.Y., W.R.), Saarland University Medical Center, Homburg, Germany.'}, {'ForeName': 'Ruben', 'Initials': 'R', 'LastName': 'Mühl-Benninghaus', 'Affiliation': 'Department of Neuroradiology (M.K., S.R., R.M.-B., A.S., U.Y., W.R.), Saarland University Medical Center, Homburg, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Simgen', 'Affiliation': 'Department of Neuroradiology (M.K., S.R., R.M.-B., A.S., U.Y., W.R.), Saarland University Medical Center, Homburg, Germany.'}, {'ForeName': 'Umut', 'Initials': 'U', 'LastName': 'Yilmaz', 'Affiliation': 'Department of Neuroradiology (M.K., S.R., R.M.-B., A.S., U.Y., W.R.), Saarland University Medical Center, Homburg, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Ruckes', 'Affiliation': 'Interdisciplinary Center of Clinical Studies, Johannes Gutenberg University, Mainz, Germany (C.R., K.K.).'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Kronfeld', 'Affiliation': 'Interdisciplinary Center of Clinical Studies, Johannes Gutenberg University, Mainz, Germany (C.R., K.K.).'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Bachhuber', 'Affiliation': 'Department of Neurology (M.F., D.G., S.A.H., S. Walter, M.L., M.B., K.F.), Saarland University Medical Center, Homburg, Germany.'}, {'ForeName': 'Iris Q', 'Initials': 'IQ', 'LastName': 'Grunwald', 'Affiliation': 'Department of Neuroscience, Medical School, Anglia Ruskin University, Chelmsford, United Kingdom and Division of Imaging Science and Technology, School of Medicine, University of Dundee, United Kingdom (I.Q.G.).'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bertsch', 'Affiliation': 'Institute of Clinical Chemistry, Laboratory Medicine and Transfusion Medicine, Paracelsus Medical University, Nuremberg, Germany (T.B.).'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Reith', 'Affiliation': 'Department of Neuroradiology (M.K., S.R., R.M.-B., A.S., U.Y., W.R.), Saarland University Medical Center, Homburg, Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Fassbender', 'Affiliation': 'Department of Neurology (M.F., D.G., S.A.H., S. Walter, M.L., M.B., K.F.), Saarland University Medical Center, Homburg, Germany.'}]",Stroke,['10.1161/STROKEAHA.120.029222']
2852,32865377,Cardiovascular and Renal Outcomes with Empagliflozin in Heart Failure.,"BACKGROUND


Sodium-glucose cotransporter 2 (SGLT2) inhibitors reduce the risk of hospitalization for heart failure in patients regardless of the presence or absence of diabetes. More evidence is needed regarding the effects of these drugs in patients across the broad spectrum of heart failure, including those with a markedly reduced ejection fraction.
METHODS


In this double-blind trial, we randomly assigned 3730 patients with class II, III, or IV heart failure and an ejection fraction of 40% or less to receive empagliflozin (10 mg once daily) or placebo, in addition to recommended therapy. The primary outcome was a composite of cardiovascular death or hospitalization for worsening heart failure.
RESULTS


During a median of 16 months, a primary outcome event occurred in 361 of 1863 patients (19.4%) in the empagliflozin group and in 462 of 1867 patients (24.7%) in the placebo group (hazard ratio for cardiovascular death or hospitalization for heart failure, 0.75; 95% confidence interval [CI], 0.65 to 0.86; P<0.001). The effect of empagliflozin on the primary outcome was consistent in patients regardless of the presence or absence of diabetes. The total number of hospitalizations for heart failure was lower in the empagliflozin group than in the placebo group (hazard ratio, 0.70; 95% CI, 0.58 to 0.85; P<0.001). The annual rate of decline in the estimated glomerular filtration rate was slower in the empagliflozin group than in the placebo group (-0.55 vs. -2.28 ml per minute per 1.73 m 2  of body-surface area per year, P<0.001), and empagliflozin-treated patients had a lower risk of serious renal outcomes. Uncomplicated genital tract infection was reported more frequently with empagliflozin.
CONCLUSIONS


Among patients receiving recommended therapy for heart failure, those in the empagliflozin group had a lower risk of cardiovascular death or hospitalization for heart failure than those in the placebo group, regardless of the presence or absence of diabetes. (Funded by Boehringer Ingelheim and Eli Lilly; EMPEROR-Reduced ClinicalTrials.gov number, NCT03057977.).",2020,"The total number of hospitalizations for heart failure was lower in the empagliflozin group than in the placebo group (hazard ratio, 0.70; 95% CI, 0.58 to 0.85; P<0.001).","['patients regardless of the presence or absence of diabetes', '3730 patients with class II, III, or IV heart failure and an ejection fraction of 40% or less to receive', 'Heart Failure', 'patients receiving recommended therapy for heart failure, those in the']","['Sodium-glucose cotransporter 2 (SGLT2) inhibitors', 'Empagliflozin', 'empagliflozin', 'placebo']","['presence or absence of diabetes', 'Cardiovascular and Renal Outcomes', 'lower risk of serious renal outcomes', 'cardiovascular death or hospitalization for heart failure', 'glomerular filtration rate', 'Uncomplicated genital tract infection', 'composite of cardiovascular death or hospitalization for worsening heart failure', 'total number of hospitalizations for heart failure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0441886', 'cui_str': 'Class 2'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C2314882', 'cui_str': 'Genital Tract Infections'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",3730.0,0.648207,"The total number of hospitalizations for heart failure was lower in the empagliflozin group than in the placebo group (hazard ratio, 0.70; 95% CI, 0.58 to 0.85; P<0.001).","[{'ForeName': 'Milton', 'Initials': 'M', 'LastName': 'Packer', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Stefan D', 'Initials': 'SD', 'LastName': 'Anker', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Butler', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Gerasimos', 'Initials': 'G', 'LastName': 'Filippatos', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Stuart J', 'Initials': 'SJ', 'LastName': 'Pocock', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Carson', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Januzzi', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Subodh', 'Initials': 'S', 'LastName': 'Verma', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Tsutsui', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Brueckmann', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Waheed', 'Initials': 'W', 'LastName': 'Jamal', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Kimura', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Schnee', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Cordula', 'Initials': 'C', 'LastName': 'Zeller', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Cotton', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Edimar', 'Initials': 'E', 'LastName': 'Bocchi', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Böhm', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Dong-Ju', 'Initials': 'DJ', 'LastName': 'Choi', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Vijay', 'Initials': 'V', 'LastName': 'Chopra', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Chuquiure', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Giannetti', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Janssens', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Jose R', 'Initials': 'JR', 'LastName': 'Gonzalez Juanatey', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Kaul', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Hans-Peter', 'Initials': 'HP', 'LastName': 'Brunner-La Rocca', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Bela', 'Initials': 'B', 'LastName': 'Merkely', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Nicholls', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Perrone', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Ileana', 'Initials': 'I', 'LastName': 'Pina', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Ponikowski', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Naveed', 'Initials': 'N', 'LastName': 'Sattar', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Senni', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Marie-France', 'Initials': 'MF', 'LastName': 'Seronde', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Jindrich', 'Initials': 'J', 'LastName': 'Spinar', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Iain', 'Initials': 'I', 'LastName': 'Squire', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Taddei', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Wanner', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Faiez', 'Initials': 'F', 'LastName': 'Zannad', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2022190']
2853,32865422,Development of Professional Care Program for Nurses in Dementia Wards and Its Educational Effects.,"PURPOSE


To develop an education program for nurses specializing in dementia care, and to investigate its effects.
METHODS


An intervention study of nurses was conducted using a quasi-experiment with 3 randomly assigned groups. Participants were 51 nurses from a psychiatric hospital dementia ward, divided into an intervention program group (17 nurses), a knowledge-acquisition-only group (16 nurses), and a usual-care group (18 nurses) as controls. The program group intervention comprised 3 frameworks: motivation for achieving the task, acquisition of professional knowledge required for dementia care, and sharing of successful experiences based on professional knowledge. The knowledge-acquisition-only group received only the acquisition of professional knowledge framework, and the usual-care group received only the usual-care framework. The intervention period was 3 months.
RESULTS


Post-intervention, the program group had a significantly greater sense of self-efficacy associated with professional knowledge and significantly greater self-efficacy associated with practice compared with the knowledge-acquisition-only and the usual-care groups. Professional knowledge was acquired by 80% of the program group, compared with 70% of the knowledge-acquisition-only group. A co-occurrence network diagram of the multivariate analysis results produced by text mining of the descriptive data indicated that nurses provided care for symptoms specific to different diseases based on their pathological mechanisms.
CONCLUSION


Program implementation led to the acquisition of deeper knowledge and greater self-efficacy by sharing expertise-based practices and successful experiences, compared with desk-based learning in a single workshop lecture, suggesting the program's usefulness in clinical practice.",2020,"Professional knowledge was acquired by 80% of the program group, compared with 70% of the knowledge-acquisition-only group.","['nurses specializing in dementia care', 'Participants were 51 nurses from a psychiatric hospital dementia ward, divided into an intervention program group (17 nurses), a']","['knowledge-acquisition-only group (16 nurses), and a usual-care group', 'Professional Care Program', 'program group intervention comprised 3 frameworks: motivation for achieving the task, acquisition of professional knowledge required for dementia care, and sharing of successful experiences based on professional knowledge']","['Professional knowledge', 'self-efficacy', 'sense of self-efficacy']","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0020021', 'cui_str': 'Psychiatric hospital'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}]",51.0,0.0169535,"Professional knowledge was acquired by 80% of the program group, compared with 70% of the knowledge-acquisition-only group.","[{'ForeName': 'Yoko', 'Initials': 'Y', 'LastName': 'Takeuchi', 'Affiliation': 'Division of Health Sciences, Graduate School of Medical Sciences, Kanazawa University, Kanazawa, Ishikawa, Japan.'}, {'ForeName': 'Mayumi', 'Initials': 'M', 'LastName': 'Kato', 'Affiliation': 'Faculty of Health Sciences, Institute of Medical, Pharmaceutical and Health Sciences, Kanazawa University, Kanazawa, Ishikawa, Japan.'}, {'ForeName': 'Tatsuru', 'Initials': 'T', 'LastName': 'Kitamura', 'Affiliation': 'Ishikawa Prefectural Takamatsu Hospital, Kahoku, Ishikawa, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Toda', 'Affiliation': 'Department of Nursing, Toyama Prefectural University, Toyama, Japan.'}, {'ForeName': 'Yoshimi', 'Initials': 'Y', 'LastName': 'Taniguchi', 'Affiliation': 'Faculty of Health Sciences, Institute of Medical, Pharmaceutical and Health Sciences, Kanazawa University, Kanazawa, Ishikawa, Japan.'}, {'ForeName': 'Miho', 'Initials': 'M', 'LastName': 'Shogenji', 'Affiliation': 'Faculty of Health Sciences, Institute of Medical, Pharmaceutical and Health Sciences, Kanazawa University, Kanazawa, Ishikawa, Japan.'}, {'ForeName': 'Hiromasa', 'Initials': 'H', 'LastName': 'Tsujiguchi', 'Affiliation': 'Faculty of Health Sciences, Institute of Medical, Pharmaceutical and Health Sciences, Kanazawa University, Kanazawa, Ishikawa, Japan.'}]",American journal of Alzheimer's disease and other dementias,['10.1177/1533317520950925']
2854,32947067,Perspectives of patients and health professionals on important factors influencing rehabilitation following acute pulmonary embolism: A multi-method study.,"BACKGROUND


International guidelines on pulmonary embolism (PE) management and rehabilitation have recently been published. However, the contained recommendation about an efficient follow-up strategy after PE is difficult for health care professionals to implement because limited research exists about what strategies are efficient.
OBJECTIVES


The study aimed to 1) describe and explore perspectives and experiences of health care professionals (HCPs) and patients participating in a post-PE rehabilitation intervention, and 2) provide suggestions for future post-PE management and rehabilitation interventions.
PATIENTS/METHODS


The study was a multi-method study, nested in a larger randomized controlled trial, combining data from two focus group interviews with 10 HCPs, 16 individual interviews with patients, data from exercise diaries and logbooks from HCPs participating in a rehabilitation intervention.
RESULTS


Key factors for successful post-PE management, considered important for reducing anxiety and confusion by both patients and HCPs, were the presence of a multidisciplinary specialized team, initiation of management shortly after discharge, and having regular follow-ups, e.g. telephone consultations. In terms of rehabilitation, repeatedly testing physical performance, resuming exercise under the guidance and support of specialized personnel, and access to peer support, were considered important for increasing motivation and self-efficacy for engaging in physical activity again.
CONCLUSIONS


This study offers suggestions for key elements to include in post-PE management and rehabilitation interventions, as well as the structuring of care. However, research still needs to be undertaken before solid recommendations for the content and structure of successful post-PE management and rehabilitation can be given.",2020,"Key factors for successful post-PE management, considered important for reducing anxiety and confusion by both patients and HCPs, were the presence of a multidisciplinary specialized team, initiation of management shortly after discharge, and having regular follow-ups, e.g. telephone consultations.","['two focus group interviews with 10 HCPs, 16 individual interviews with patients, data from exercise diaries and logbooks from HCPs participating in a rehabilitation intervention', 'acute pulmonary embolism']","['health care professionals (HCPs) and patients participating in a post-PE rehabilitation intervention, and 2) provide suggestions for future post-PE management and rehabilitation interventions']",[],"[{'cui': 'C0016400', 'cui_str': 'Focus Groups'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2882221', 'cui_str': 'Acute pulmonary embolism'}]","[{'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0038659', 'cui_str': 'Suggestion'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]",[],,0.070874,"Key factors for successful post-PE management, considered important for reducing anxiety and confusion by both patients and HCPs, were the presence of a multidisciplinary specialized team, initiation of management shortly after discharge, and having regular follow-ups, e.g. telephone consultations.","[{'ForeName': 'Nanna', 'Initials': 'N', 'LastName': 'Rolving', 'Affiliation': 'Diagnostic Centre, Silkeborg Regional Hospital, Silkeborg, Denmark; DEFACTUM, Corporate Quality, Central Denmark Region, Aarhus, Denmark. Electronic address: Nanna.Rolving@rm.dk.'}, {'ForeName': 'Jannie Rhod', 'Initials': 'JR', 'LastName': 'Bloch-Nielsen', 'Affiliation': 'Diagnostic Centre, Silkeborg Regional Hospital, Silkeborg, Denmark.'}, {'ForeName': 'Barbara Christina', 'Initials': 'BC', 'LastName': 'Brocki', 'Affiliation': 'Department of Physical and Occupational Therapy, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Andreasen', 'Affiliation': 'Department of Physical and Occupational Therapy, Aalborg University Hospital, Aalborg, Denmark; Public Health and Epidemiology Group, Department of Health, Science and Technology, Aalborg University, Denmark.'}]",Thrombosis research,['10.1016/j.thromres.2020.09.016']
2855,32955451,Nonprofessional Peer Support to Improve Mental Health: Randomized Trial of a Scalable Web-Based Peer Counseling Course.,"BACKGROUND


Millions of people worldwide are underserved by the mental health care system. Indeed, most mental health problems go untreated, often because of resource constraints (eg, limited provider availability and cost) or lack of interest or faith in professional help. Furthermore, subclinical symptoms and chronic stress in the absence of a mental illness diagnosis often go unaddressed, despite their substantial health impact. Innovative and scalable treatment delivery methods are needed to supplement traditional therapies to fill these gaps in the mental health care system.
OBJECTIVE


This study aims to investigate whether a self-guided web-based course can teach pairs of nonprofessional peers to deliver psychological support to each other.
METHODS


In this experimental study, a community sample of 30 dyads (60 participants, mostly friends), many of whom presented with mild to moderate psychological distress, were recruited to complete a web-based counseling skills course. Dyads were randomized to either immediate or delayed access to training. Before and after training, dyads were recorded taking turns discussing stressors. Participants' skills in the helper role were assessed before and after taking the course: the first author and a team of trained research assistants coded recordings for the presence of specific counseling behaviors. When in the client role, participants rated the session on helpfulness in resolving their stressors and supportiveness of their peers. We hypothesized that participants would increase the use of skills taught by the course and decrease the use of skills discouraged by the course, would increase their overall adherence to the guidelines taught in the course, and would perceive posttraining counseling sessions as more helpful and their peers as more supportive.
RESULTS


The course had large effects on most helper-role speech behaviors: helpers decreased total speaking time, used more restatements, made fewer efforts to influence the speaker, and decreased self-focused and off-topic utterances (ds=0.8-1.6). When rating the portion of the session in which they served as clients, participants indicated that they made more progress in addressing their stressors during posttraining counseling sessions compared with pretraining sessions (d=1.1), but they did not report substantive changes in feelings of closeness and supportiveness of their peers (d=0.3).
CONCLUSIONS


The results provide proof of concept that nonprofessionals can learn basic counseling skills from a scalable web-based course. The course serves as a promising model for the development of web-based counseling skills training, which could provide accessible mental health support to some of those underserved by traditional psychotherapy.",2020,"The course had large effects on most helper-role speech behaviors: helpers decreased total speaking time, used more restatements, made fewer efforts to influence the speaker, and decreased self-focused and off-topic utterances (ds=0.8-1.6).","['community sample of 30 dyads (60 participants, mostly friends), many of whom presented with mild to moderate psychological distress, were recruited to complete a web-based counseling skills course', 'Mental Health']","['Scalable Web-Based Peer Counseling Course', 'immediate or delayed access to training']",[],"[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0079382', 'cui_str': 'Friend'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]",[],60.0,0.0411658,"The course had large effects on most helper-role speech behaviors: helpers decreased total speaking time, used more restatements, made fewer efforts to influence the speaker, and decreased self-focused and off-topic utterances (ds=0.8-1.6).","[{'ForeName': 'Samantha L', 'Initials': 'SL', 'LastName': 'Bernecker', 'Affiliation': 'Department of Health Care Policy, Harvard Medical School, Boston, MA, United States.'}, {'ForeName': 'Joseph Jay', 'Initials': 'JJ', 'LastName': 'Williams', 'Affiliation': 'Department of Computer Science, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Norian A', 'Initials': 'NA', 'LastName': 'Caporale-Berkowitz', 'Affiliation': 'Department of Educational Psychology, University of Texas at Austin, Austin, TX, United States.'}, {'ForeName': 'Akash R', 'Initials': 'AR', 'LastName': 'Wasil', 'Affiliation': 'Department of Psychology, University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Constantino', 'Affiliation': 'Department of Psychological and Brain Sciences, University of Massachusetts Amherst, Amherst, MA, United States.'}]",Journal of medical Internet research,['10.2196/17164']
2856,32950505,Social media use while listening to new material negatively affects short-term memory in college students.,"Increased access to electronic devices and the ubiquity of social media has resulted in a rapid rise in the prevalence of students ""multitasking"" while in a classroom setting. While some data indicate the use of electronic devices in class can improve the classroom environment, other studies demonstrate the opposite finding. Moreover, it remains unclear if using social networking sites such as Instagram impacts performance on cognitive tasks when students are presented new material and, if so, what features of Instagram modulate this response. Therefore, in the current study we examined if social media use during or after being presented new information affected short-term memory in college students. Additionally, we assessed if the type or quantity of topics displayed had a modulatory impact on memory. Forty-five college-aged (18-24 years of age) students completed the Logical Memory Immediate Recall (LM I) component of the Wechsler Memory Scale IV, a measure of auditory recognition memory. Subjects were randomly divided into a group that completed the LM I without distraction (controls), a group that completed the LM I while scrolling through their Instagram feed, or a group that completed the LM I after scrolling through their Instagram feed. Subjects that used Instagram while being presented new information demonstrated worse short-term memory recall ability compared to subjects that did not use Instagram during the presentation (71.56% correct answers vs. 80.89%; p = 0.01). Recall ability in the group that used Instagram after hearing the story was not statistically different from the controls. Differences were not observed in the number of topics appearing in subjects' Instagram feeds and no correlation was found between the number of topics on a subject's Instagram feed and memory recall ability. Collectively, these results suggest that individuals who use their phones to browse Instagram during class or in social settings might have a reduced ability to retain the information given to them when compared to those that are not using their phones scrolling on social media.",2020,Subjects that used Instagram while being presented new information demonstrated worse short-term memory recall ability compared to subjects that did not use Instagram during the presentation (71.56% correct answers vs. 80.89%; p = 0.01).,"['Forty-five college-aged (18-24 years of age', 'college students', 'College Students']","['LM I without distraction (controls), a group that completed the LM I while scrolling through their Instagram feed, or a group that completed the LM']","['Logical Memory Immediate Recall (LM I) component of the Wechsler Memory Scale IV, a measure of auditory recognition memory', 'Recall ability', 'short-term memory recall ability']","[{'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0242393', 'cui_str': 'Immediate Recall'}, {'cui': 'C0150189', 'cui_str': 'Distraction training'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}]","[{'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0242393', 'cui_str': 'Immediate Recall'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0451575', 'cui_str': 'Wechsler memory scale'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}]",,0.024727,Subjects that used Instagram while being presented new information demonstrated worse short-term memory recall ability compared to subjects that did not use Instagram during the presentation (71.56% correct answers vs. 80.89%; p = 0.01).,"[{'ForeName': 'Allyson', 'Initials': 'A', 'LastName': 'Spence', 'Affiliation': 'Department of Biology, D-8, Regis University, Denver, CO 80221, USA.'}, {'ForeName': 'Kierian', 'Initials': 'K', 'LastName': 'Beasley', 'Affiliation': 'Department of Biology, D-8, Regis University, Denver, CO 80221, USA.'}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Gravenkemper', 'Affiliation': 'Department of Biology, D-8, Regis University, Denver, CO 80221, USA.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Hoefler', 'Affiliation': 'Department of Biology, D-8, Regis University, Denver, CO 80221, USA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Ngo', 'Affiliation': 'Department of Biology, D-8, Regis University, Denver, CO 80221, USA.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Ortiz', 'Affiliation': 'Department of Biology, D-8, Regis University, Denver, CO 80221, USA.'}, {'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Campisi', 'Affiliation': 'Department of Biology, D-8, Regis University, Denver, CO 80221, USA. Electronic address: jcampisi@regis.edu.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113172']
2857,32950939,Feasibility and efficacy of a digital CBT intervention for symptoms of Generalized Anxiety Disorder: A randomized multiple-baseline study.,"BACKGROUND AND OBJECTIVES


Cognitive behavioral therapy (CBT) is a first-line treatment for anxiety, but it is not widely available as clinical guidelines recommend. We examined the feasibility and efficacy of a novel smartphone-based fully automated digital CBT intervention, 'Daylight™', to improve symptoms of Generalized Anxiety Disorder (GAD).
METHODS


In this multiple-baseline design, 21 adults (20 F; mean age 43yrs. range 19-65yrs.) with moderate-to-severe symptoms of GAD were randomized to one of three baseline durations (2-, 4-, or 6-weeks) and then received access to digital CBT. Participants completed daily ratings of anxiety and worry, weekly measures of anxiety, depressive symptoms, and sleep, and measures of anxiety, worry, wellbeing, quality of life, CBT skill acquisition, and work performance at initial assessment prior to baseline randomization, post-intervention, and follow-up.
RESULTS


Digital CBT was found to be feasible in terms of engagement, satisfaction, and safety. For preliminary efficacy, improvements were detected in daily and weekly outcomes of anxiety for most participants. Despite individual differences, significant improvements occurred with the introduction of digital CBT and not during baseline. Overall, 70% of participants no longer had clinically significant symptoms of GAD, 61% no longer had significant depressive symptoms, and 40% no longer had significant sleep difficulty at post-intervention.
LIMITATIONS


The study sample was recruited using the internet and was mostly female, limiting the generalizability of the findings.
CONCLUSIONS


Findings support the feasibility and efficacy of Daylight. Further examination in randomized controlled trials is now warranted.",2020,"Despite individual differences, significant improvements occurred with the introduction of digital CBT and not during baseline.","['21 adults (20\xa0F; mean age 43yrs', 'range 19-65yrs.) with moderate-to-severe symptoms of GAD', 'Generalized Anxiety Disorder']","['digital CBT intervention', ""novel smartphone-based fully automated digital CBT intervention, 'Daylight™"", 'Cognitive behavioral therapy (CBT']","['depressive symptoms', 'daily ratings of anxiety and worry, weekly measures of anxiety, depressive symptoms, and sleep, and measures of anxiety, worry, wellbeing, quality of life, CBT skill acquisition, and work performance at initial assessment prior to baseline randomization, post-intervention, and follow-up', 'Feasibility and efficacy', 'engagement, satisfaction, and safety']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205554', 'cui_str': 'Automated'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C1286385', 'cui_str': 'Performance at work'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",21.0,0.0552773,"Despite individual differences, significant improvements occurred with the introduction of digital CBT and not during baseline.","[{'ForeName': 'Christopher B', 'Initials': 'CB', 'LastName': 'Miller', 'Affiliation': 'Big Health Inc., San Francisco, CA, USA; Big Health Inc., London, UK; Sleep and Circadian Neuroscience Institute, Nuffield Department of Clinical Neurosciences, Sir William Dunn School of Pathology, University of Oxford, Oxford, UK. Electronic address: chris.miller@bighealth.com.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Gu', 'Affiliation': 'Big Health Inc., San Francisco, CA, USA; Big Health Inc., London, UK; University Department of Psychiatry, University of Oxford and Oxford Health NHS Trust, Warneford Hospital, Oxford, UK.'}, {'ForeName': 'Alasdair L', 'Initials': 'AL', 'LastName': 'Henry', 'Affiliation': 'Big Health Inc., San Francisco, CA, USA; Big Health Inc., London, UK; Sleep and Circadian Neuroscience Institute, Nuffield Department of Clinical Neurosciences, Sir William Dunn School of Pathology, University of Oxford, Oxford, UK.'}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Davis', 'Affiliation': 'Big Health Inc., San Francisco, CA, USA; Big Health Inc., London, UK.'}, {'ForeName': 'Colin A', 'Initials': 'CA', 'LastName': 'Espie', 'Affiliation': 'Big Health Inc., San Francisco, CA, USA; Big Health Inc., London, UK; Sleep and Circadian Neuroscience Institute, Nuffield Department of Clinical Neurosciences, Sir William Dunn School of Pathology, University of Oxford, Oxford, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Stott', 'Affiliation': 'Big Health Inc., San Francisco, CA, USA; Big Health Inc., London, UK; University Department of Psychiatry, University of Oxford and Oxford Health NHS Trust, Warneford Hospital, Oxford, UK.'}, {'ForeName': 'Adrienne J', 'Initials': 'AJ', 'LastName': 'Heinz', 'Affiliation': 'Big Health Inc., San Francisco, CA, USA; Big Health Inc., London, UK.'}, {'ForeName': 'Kate H', 'Initials': 'KH', 'LastName': 'Bentley', 'Affiliation': 'Derner School of Psychology, Adelphi University, Garden City, NY, USA.'}, {'ForeName': 'Guy M', 'Initials': 'GM', 'LastName': 'Goodwin', 'Affiliation': 'University Department of Psychiatry, University of Oxford and Oxford Health NHS Trust, Warneford Hospital, Oxford, UK.'}, {'ForeName': 'Bernard S', 'Initials': 'BS', 'LastName': 'Gorman', 'Affiliation': 'Department of Psychology, Harvard University, Cambridge, MA, USA.'}, {'ForeName': 'Michelle G', 'Initials': 'MG', 'LastName': 'Craske', 'Affiliation': 'Anxiety and Depression Research Centre (ADRC), UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Jenna R', 'Initials': 'JR', 'LastName': 'Carl', 'Affiliation': 'Big Health Inc., San Francisco, CA, USA; Big Health Inc., London, UK.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101609']
2858,32951002,The effect of intranasal oxytocin on visual processing and salience of human faces.,"The mechanisms underlying the role of oxytocin (OT) as a regulator of social behavior in mammals are only partly understood. Recently, it has been proposed that OT increases the salience of social stimuli. We carried out a randomized, double-blind, cross-over study of the effects of OT on binocular rivalry, a visual phenomenon underpinned by the interplay of excitation and inhibition in the cortex. A final sample of 45 participants viewed images of social stimuli (faces with different emotional expressions) and non-social stimuli (houses and Gabor patches). We demonstrate a robust effect that intranasal OT increases the salience of human faces in binocular rivalry, such that dominance durations of faces are longer-this effect is not modulated by the facial expression. We tentatively show that OT treatment increases dominance durations for non-social stimuli. Our results lend support to the social salience hypothesis of OT, and in addition offer provisional support for the role of OT in influencing excitation-inhibition balance in the brain.",2020,A final sample of 45 participants viewed images of social stimuli (faces with different emotional expressions) and non-social stimuli (houses and Gabor patches).,['45 participants viewed images of social stimuli (faces with different emotional expressions) and non-social stimuli (houses and Gabor patches'],"['OT', 'intranasal OT', 'intranasal oxytocin', 'oxytocin (OT']",['visual processing and salience of human faces'],"[{'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}]","[{'cui': 'C0589087', 'cui_str': 'Visual processing'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}]",45.0,0.0455496,A final sample of 45 participants viewed images of social stimuli (faces with different emotional expressions) and non-social stimuli (houses and Gabor patches).,"[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Hovey', 'Affiliation': 'Department of Pharmacology, Institute of Neuroscience and Physiology, The Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden. daniel.hovey@neuro.gu.se.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Martens', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Laeng', 'Affiliation': 'Department of Psychology, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Siri', 'Initials': 'S', 'LastName': 'Leknes', 'Affiliation': 'Department of Psychology, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Westberg', 'Affiliation': 'Department of Pharmacology, Institute of Neuroscience and Physiology, The Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}]",Translational psychiatry,['10.1038/s41398-020-00991-3']
2859,32956008,Verbal Contingencies in the Lidcombe Program: A Noninferiority Trial.,"Purpose The Lidcombe Program is an efficacious and effective intervention for early stuttering. The treatment is based on parent verbal response contingent stimulation procedures, which are assumed to be responsible for treatment effect. The present trial tested this assumption. Method The design was a parallel, open plan, noninferiority randomized controlled trial. In the experimental arm, the five Lidcombe Program verbal contingencies were removed from parent instruction. The primary outcome was beyond-clinic percentage syllables stuttered at 18-month follow-up. Seventy-four children and their parents were randomized to one of the two treatment arms. Results Findings of noninferiority were inconclusive for the primary outcome of stuttering severity, based on a margin of 1.0 percentage syllables stuttered. Conclusions The inconclusive finding of noninferiority means it is possible that verbal contingencies make some contribution to the Lidcombe Program treatment effect. However, considering all primary and secondary outcomes, an overriding impression from the trial is a similarity of outcomes between the control and experimental arms. The clinical applications of the trial are discussed, along with further research that is needed.",2020,"Results Findings of noninferiority were inconclusive for the primary outcome of stuttering severity, based on a margin of 1.0 percentage syllables stuttered.","['Lidcombe Program', 'Seventy-four children and their parents']",['Lidcombe Program'],"['Verbal Contingencies', 'beyond-clinic percentage syllables stuttered']","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C4517867', 'cui_str': '74'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030551', 'cui_str': 'Parent'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0038506', 'cui_str': 'Stuttering'}]",74.0,0.0786426,"Results Findings of noninferiority were inconclusive for the primary outcome of stuttering severity, based on a margin of 1.0 percentage syllables stuttered.","[{'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Donaghy', 'Affiliation': 'Australian Catholic University, North Sydney, New South Wales, Australia.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': ""O'Brian"", 'Affiliation': 'Australian Stuttering Research Centre, University of Technology Sydney, New South Wales, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Onslow', 'Affiliation': 'Australian Stuttering Research Centre, University of Technology Sydney, New South Wales, Australia.'}, {'ForeName': 'Robyn', 'Initials': 'R', 'LastName': 'Lowe', 'Affiliation': 'Australian Stuttering Research Centre, University of Technology Sydney, New South Wales, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Jones', 'Affiliation': 'School of Public Health, The University of Queensland, Herston, Australia.'}, {'ForeName': 'Ross G', 'Initials': 'RG', 'LastName': 'Menzies', 'Affiliation': 'Australian Stuttering Research Centre, University of Technology Sydney, New South Wales, Australia.'}]","Journal of speech, language, and hearing research : JSLHR",['10.1044/2020_JSLHR-20-00155']
2860,32956694,Evaluation of the effect of a new oral contraceptive containing estetrol and drospirenone on hemostasis parameters.,"OBJECTIVE


To assess the effect on hemostasis parameters of a new combined oral contraceptive (COC).
STUDY DESIGN


In this randomized, single centre, open-label, exploratory study, healthy women received either 15 mg estetrol/3 mg drospirenone (E4/DRSP) (n = 39), 30 mcg ethinylestradiol/150 mcg levonorgestrel (EE/LNG) (n = 30), or 20 mcg ethinylestradiol/3 mg drospirenone (EE/DRSP) (n = 32) for six 28-day cycles. Blood was collected at baseline, cycle 3, and cycle 6. Median change from baseline was evaluated for procoagulant, anticoagulant, and fibrinolytic parameters, and for sex hormone-binding globulin (SHBG).
RESULTS


Median change of endogenous thrombin potential (ETP) based activated protein C sensitivity resistance (APCr) at cycle 6 was +30% for E4/DRSP, +165% for EE/LNG (p-value <0.05 vs E4/DRSP), and +219% for EE/DRSP (p-value <0.05 vs E4/DRSP). Changes to prothrombin fragment 1 + 2 and SHBG for E4/DRSP, EE/LNG, and EE/DRSP were +23%, +71%, and +64% (p-value <0.05 vs E4/DRSP); and +55%, +74% and +251% (p-value <0.05 vs E4/DRSP), respectively. At cycle 6, changes to other hemostasis parameters for E4/DRSP were similar or smaller than for EE/LNG or EE/DRSP.
CONCLUSIONS


In this study, changes in hemostasis parameters after treatment with 6 cycles of E4/DRSP were smaller or similar to those observed for EE/LNG. Similar, but more pronounced changes were also observed versus EE/DRSP, which supports the hypothesis that the effect of COCs on hemostasis parameters is mainly mediated by the estrogenic component. Further studies are needed to provide more insight into the venous thromboembolic risk of E4/DRSP.
IMPLICATIONS STATEMENT


This study reports that the effects on hemostasis parameters of a COC containing 15 mg E4/3 mg DRSP are less or similar to those for EE/LNG or EE/DRSP. It also demonstrates that the choice of estrogen modulates the effects of COCs on hemostasis parameters.",2020,"At cycle 6, changes to other hemostasis parameters for E4/DRSP were similar or smaller than for EE/LNG or EE/DRSP.
",['healthy women received either 15 mg estetrol /3'],"['ethinylestradiol /3', 'ethinylestradiol /150 mcg levonorgestrel (EE/LNG', 'drospirenone', 'COC containing 15 mg E4/3 mg DRSP', 'E4/DRSP', 'new combined oral contraceptive (COC', 'EE/DRSP', 'drospirenone (E4/DRSP', 'new oral contraceptive containing estetrol and drospirenone']","['hemostasis parameters', 'endogenous thrombin potential (ETP) based activated protein C sensitivity resistance (APCr']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0014899', 'cui_str': '15 alpha-Hydroxyestriol'}]","[{'cui': 'C0015011', 'cui_str': 'Ethinyl Estradiol'}, {'cui': 'C0439211', 'cui_str': 'mcg'}, {'cui': 'C0023566', 'cui_str': 'Levonorgestrel'}, {'cui': 'C0043822', 'cui_str': 'drospirenone'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0009906', 'cui_str': 'Oral Contraceptives, Combined'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0014899', 'cui_str': '15 alpha-Hydroxyestriol'}]","[{'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205227', 'cui_str': 'Endogenous'}, {'cui': 'C0040018', 'cui_str': 'Thrombin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0483249', 'cui_str': 'Protein C (activated)'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}]",,0.0347076,"At cycle 6, changes to other hemostasis parameters for E4/DRSP were similar or smaller than for EE/LNG or EE/DRSP.
","[{'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Douxfils', 'Affiliation': 'Qualiblood SA, Namur, Belgium; Department of Pharmacy, Namur Thrombosis and Hemostasis Center, NAmur Research Institute for LIfe Sciences, University of Namur, Namur, Belgium.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Klipping', 'Affiliation': 'Dinox BV, Groningen, the Netherlands.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Duijkers', 'Affiliation': 'Dinox BV, Groningen, the Netherlands.'}, {'ForeName': 'Virginie', 'Initials': 'V', 'LastName': 'Kinet', 'Affiliation': ""Estetra SPRL, an affiliate's company of Mithra Pharmaceuticals, Liège, Belgium.""}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Mawet', 'Affiliation': ""Estetra SPRL, an affiliate's company of Mithra Pharmaceuticals, Liège, Belgium.""}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Maillard', 'Affiliation': ""Estetra SPRL, an affiliate's company of Mithra Pharmaceuticals, Liège, Belgium.""}, {'ForeName': 'Maud', 'Initials': 'M', 'LastName': 'Jost', 'Affiliation': ""Estetra SPRL, an affiliate's company of Mithra Pharmaceuticals, Liège, Belgium. Electronic address: mjost@mithra.com.""}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Rosing', 'Affiliation': 'Department of Biochemistry, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Jean-Michel', 'Initials': 'JM', 'LastName': 'Foidart', 'Affiliation': ""Estetra SPRL, an affiliate's company of Mithra Pharmaceuticals, Liège, Belgium; University of Liège, Liège, Belgium.""}]",Contraception,['10.1016/j.contraception.2020.08.015']
2861,32956756,"Efficacy and safety of mepolizumab in hypereosinophilic syndrome: A phase III, randomized, placebo-controlled trial.","BACKGROUND


Anti-IL-5 therapy is a potential treatment for patients with hypereosinophilic syndrome (HES), although its clinical efficacy is unclear.
OBJECTIVE


We sought to investigate the clinical efficacy and safety of mepolizumab versus placebo in patients with HES.
METHODS


This randomized, multicenter, double-blind, placebo-controlled, phase III trial was conducted across 39 centers in 13 countries. Eligible patients had FIP1L1-PDGFRA-negative HES, experienced 2 or more flares (worsening of HES-related symptoms or blood eosinophil count requiring therapeutic escalation) in the previous 12 months, and had a screening blood eosinophil count greater than or equal to 1000 cells/μL. Patients were randomized (1:1) to subcutaneous mepolizumab (300 mg) or placebo every 4 weeks for 32 weeks, plus existing HES therapy. The primary outcome was the proportion of patients with 1 or more flares (worsening of HES-related symptoms necessitating therapy escalation or ≥2 courses of blinded rescue oral corticosteroids) during the study; in addition, patients who withdrew early from the study were counted as having a flare. Safety end points were also assessed.
RESULTS


The proportion of patients experiencing 1 or more flares/withdrawing from the study was 50% lower with mepolizumab versus placebo (15 of 54 [28%] vs 30 of 54 [56%]; P = .002). Logistic regression analysis was consistent with the primary analysis (odds ratio, 0.28; 95% CI, 0.12-0.64; P = .003). Similar proportions of patients in the mepolizumab and placebo groups experienced on-treatment adverse events (48 of 54 [89%] vs 47 of 54 [87%]).
CONCLUSIONS


Compared with placebo, mepolizumab significantly reduced the occurrence of flares in patients with HES, with no new safety signals identified.",2020,"Logistic regression analysis was consistent with the primary analysis (odds ratio: 0.28; 95% confidence interval: 0.12, 0.64; p=0.003).","['hypereosinophilic syndrome', 'patients with HES', 'patients with hypereosinophilic syndrome (HES', 'Eligible patients had FIP1L1-PDGFRA-negative HES, experienced ≥2 flares (worsening of HES-related symptoms or blood eosinophil count requiring therapeutic escalation) in the previous 12 months and had a screening blood eosinophil count ≥1000 cells/μL. Patients', '39 centers in 13 countries']","['mepolizumab versus placebo', 'Anti-interleukin-5 therapy', 'plus existing HES therapy', 'mepolizumab', 'subcutaneous mepolizumab', 'placebo']","['Efficacy and safety', 'occurrence of flares', 'treatment adverse events', 'proportion of patients with ≥1 flare (worsening of HES-related symptoms necessitating therapy escalation or ≥2 courses of blinded rescue oral corticosteroids']","[{'cui': 'C0206141', 'cui_str': 'Idiopathic hypereosinophilic syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0200638', 'cui_str': 'Eosinophil count'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0454664', 'cui_str': 'Country'}]","[{'cui': 'C0969324', 'cui_str': 'mepolizumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0860389', 'cui_str': 'Interleukin-5 therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0206141', 'cui_str': 'Idiopathic hypereosinophilic syndrome'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0206141', 'cui_str': 'Idiopathic hypereosinophilic syndrome'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]",,0.685115,"Logistic regression analysis was consistent with the primary analysis (odds ratio: 0.28; 95% confidence interval: 0.12, 0.64; p=0.003).","[{'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Roufosse', 'Affiliation': 'Department of Internal Medicine, Hôpital Erasme, Université Libre de Bruxelles, Brussels, Belgium. Electronic address: froufoss@ulb.ac.be.'}, {'ForeName': 'Jean-Emmanuel', 'Initials': 'JE', 'LastName': 'Kahn', 'Affiliation': 'Department of Internal Medicine, Hôpital Ambroise Paré, Université Versailles-Saint Quentin-en-Yvelines, Boulogne-Billancourt, France.'}, {'ForeName': 'Marc E', 'Initials': 'ME', 'LastName': 'Rothenberg', 'Affiliation': ""Division of Allergy and Immunology, Cincinnati Children's Hospital Medical Center, and the Department of Pediatrics, University of Cincinnati, Cincinnati, Ohio.""}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Wardlaw', 'Affiliation': 'Institute for Lung Health, University of Leicester, Leicester, United Kingdom.'}, {'ForeName': 'Amy D', 'Initials': 'AD', 'LastName': 'Klion', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Md.'}, {'ForeName': 'Suyong Yun', 'Initials': 'SY', 'LastName': 'Kirby', 'Affiliation': 'Respiratory Therapeutic Area, GSK, Research Triangle Park, NC.'}, {'ForeName': 'Martyn J', 'Initials': 'MJ', 'LastName': 'Gilson', 'Affiliation': 'Respiratory Research and Development, GSK, Uxbridge, Middlesex, United Kingdom.'}, {'ForeName': 'Jane H', 'Initials': 'JH', 'LastName': 'Bentley', 'Affiliation': 'Clinical Statistics, GSK, Uxbridge, Middlesex, United Kingdom.'}, {'ForeName': 'Eric S', 'Initials': 'ES', 'LastName': 'Bradford', 'Affiliation': 'Respiratory Therapeutic Area, GSK, Research Triangle Park, NC.'}, {'ForeName': 'Steven W', 'Initials': 'SW', 'LastName': 'Yancey', 'Affiliation': 'Respiratory Therapeutic Area, GSK, Research Triangle Park, NC.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Steinfeld', 'Affiliation': 'Respiratory Research & Development, GSK, Collegeville, Pa.'}, {'ForeName': 'Gerald J', 'Initials': 'GJ', 'LastName': 'Gleich', 'Affiliation': 'Department of Dermatology, School of Medicine, University of Utah, Salt Lake City, Utah.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2020.08.037']
2862,32960408,Early Tumor Shrinkage and Depth of Response in the Second-Line Treatment for KRAS exon2 Wild-Type Metastatic Colorectal Cancer: An Exploratory Analysis of the Randomized Phase 2 Trial Comparing Panitumumab and Bevacizumab in Combination with FOLFIRI (WJOG6210G).,"BACKGROUND


Predictive markers for the clinical outcomes of second-line treatment in patients with metastatic colorectal cancer (mCRC) remain unclear.
OBJECTIVE


This retrospective biomarker study was conducted to explore predictive markers for patients with KRAS exon 2 wild-type mCRC who were treated with FOLFIRI plus panitumumab (Pani) or bevacizumab (Bev) in the WJOG6210G trial.
PATIENTS AND METHODS


The associations of early tumor shrinkage (ETS), tumor location, and VEGF-D with progression-free survival (PFS) and overall survival (OS) were analyzed using a Cox proportional hazards model. Spearman's correlation coefficient was used to analyze the association of depth of response (DpR) with PFS and OS. Serum VEGF-D levels were measured in samples collected before treatment using magnetic bead panel Milliplex xMAP kits.
RESULTS


In total, 101 patients (Pani, n = 49; Bev, n = 52) were enrolled in this study. Patients with ETS had longer PFS (Pani: hazard ratio (HR) 0.40, P = 0.009; Bev: HR 0.078, P = 0.0002) and OS (Pani: HR 0.49, P = 0.044; Bev: HR 0.35, P = 0.048) than patients without ETS. The DpR was moderately correlated with PFS and OS in Pani (rs = 0.75, P < 0.001; rs = 0.60, P < 0.001) and Bev groups (rs = 0.68, P < 0.001; rs = 0.44, P = 0.002). No significant differences were observed in PFS and OS between the two treatment groups even if in left-sided tumors. No significant interaction between VEGF-D levels and treatment was observed in PFS and OS.
CONCLUSIONS


ETS and DpR serve as surrogate markers of PFS and OS in the second-line treatment with FOLFIRI plus targeted agent for mCRC.",2020,"Patients with ETS had longer PFS (Pani: hazard ratio (HR) 0.40, P = 0.009; Bev: HR 0.078, P = 0.0002) and OS (Pani: HR 0.49, P = 0.044; Bev: HR 0.35, P = 0.048) than patients without ETS.","['patients with metastatic colorectal cancer (mCRC', 'patients with KRAS exon 2 wild-type mCRC who were treated with', 'KRAS exon2 Wild-Type Metastatic Colorectal Cancer', '101 patients (Pani, n\u2009=\u200949; Bev, n\u2009=\u200952']","['Panitumumab and Bevacizumab', 'FOLFIRI plus panitumumab (Pani) or bevacizumab (Bev']","['early tumor shrinkage (ETS), tumor location, and VEGF-D with progression-free survival (PFS) and overall survival (OS', 'longer PFS', 'PFS and OS', 'Early Tumor Shrinkage and Depth of Response', 'VEGF-D levels', 'Serum VEGF-D levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0015295', 'cui_str': 'Exons'}, {'cui': 'C0445392', 'cui_str': 'Wild'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0879427', 'cui_str': 'panitumumab'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]","[{'cui': 'C0879427', 'cui_str': 'panitumumab'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0332513', 'cui_str': 'Shrinkage'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0664390', 'cui_str': 'Vascular Endothelial Growth Factor-D'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]",101.0,0.0754459,"Patients with ETS had longer PFS (Pani: hazard ratio (HR) 0.40, P = 0.009; Bev: HR 0.078, P = 0.0002) and OS (Pani: HR 0.49, P = 0.044; Bev: HR 0.35, P = 0.048) than patients without ETS.","[{'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Izawa', 'Affiliation': 'Department of Clinical Oncology, St. Marianna University School of Medicine, Kawasaki, Japan.'}, {'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Shitara', 'Affiliation': 'Department of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Kimio', 'Initials': 'K', 'LastName': 'Yonesaka', 'Affiliation': 'Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka-sayama, Japan.'}, {'ForeName': 'Takeharu', 'Initials': 'T', 'LastName': 'Yamanaka', 'Affiliation': 'Department of Biostatistics, Yokohama City University School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Yoshino', 'Affiliation': 'Department of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Sunakawa', 'Affiliation': 'Department of Clinical Oncology, St. Marianna University School of Medicine, Kawasaki, Japan.'}, {'ForeName': 'Toshiki', 'Initials': 'T', 'LastName': 'Masuishi', 'Affiliation': 'Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'Tadamichi', 'Initials': 'T', 'LastName': 'Denda', 'Affiliation': 'Department of Gastroenterology, Chiba Cancer Center Hospital, Chiba, Japan.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Yamazaki', 'Affiliation': 'Division of Gastrointestinal Oncology, Shizuoka Cancer Center, Shimonagakubo, Japan.'}, {'ForeName': 'Toshikazu', 'Initials': 'T', 'LastName': 'Moriwaki', 'Affiliation': 'Division of Gastroenterology, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Okuda', 'Affiliation': 'Department of Medical Oncology, Keiyukai Sapporo Hospital, Sapporo, Japan.'}, {'ForeName': 'Chihiro', 'Initials': 'C', 'LastName': 'Kondoh', 'Affiliation': 'Department of Medical Oncology, Toranomon Hospital, Tokyo, Japan.'}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Nishina', 'Affiliation': 'Department of Gastrointestinal Medical Oncology, National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan.'}, {'ForeName': 'Akitaka', 'Initials': 'A', 'LastName': 'Makiyama', 'Affiliation': 'Department of Hematology/Oncology, Japan Community Healthcare Organization Kyushu Hospital, Kita-Kyushu, Japan.'}, {'ForeName': 'Hideo', 'Initials': 'H', 'LastName': 'Baba', 'Affiliation': 'Department of Gastroenterological Surgery, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan.'}, {'ForeName': 'Hironori', 'Initials': 'H', 'LastName': 'Yamaguchi', 'Affiliation': 'Department of Gastrointestinal Surgery, Jichi Medical University, Shimotsuke, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Nakamura', 'Affiliation': 'Aizawa Comprehensive Cancer Center, Aizawa Hospital, Matsumoto, Japan.'}, {'ForeName': 'Ichinosuke', 'Initials': 'I', 'LastName': 'Hyodo', 'Affiliation': 'Division of Gastroenterology, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.'}, {'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Muro', 'Affiliation': 'Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'Takako Eguchi', 'Initials': 'TE', 'LastName': 'Nakajima', 'Affiliation': 'Department of Clinical Oncology, St. Marianna University School of Medicine, Kawasaki, Japan. tnakajima@kuhp.kyoto-u.ac.jp.'}]",Targeted oncology,['10.1007/s11523-020-00750-w']
2863,32965223,The Impact of Previsit Contextual Data Collection on Patient-Provider Communication and Patient Activation: Study Protocol for a Randomized Controlled Trial.,"BACKGROUND


Patient-centered care is respectful of and responsive to individual patient preferences, needs, and values. To provide patient-centered care, clinicians need to know and incorporate patients' context into their communication and care with patients. Patient contextual data (PCD) encompass social determinants of health and patients' needs, values, goals, and preferences relevant to their care. PCD can be challenging to collect as a routine component of the time-limited primary care visit.
OBJECTIVE


This study aims to determine if patient-provider communication and patient activation are different for patient users and patient nonusers of an electronic health record (EHR)-integrated PCD tool and assess if the impact of using PCD on patient-provider communication and patient activation differs for Black and White patients.
METHODS


We describe a randomized controlled trial of a prospective cohort of non-Hispanic White and Black patients who receive primary care services at a midwestern academic health care system in the United States. We will evaluate whether providing PCD through a consumer informatics tool enhances patient-provider communication, as measured by the Communication Assessment Tool, and we will evaluate patient activation, as measured by the Patient Activation Measure for PCD tool users and nonusers. Furthermore, owing to racial disparities in care and communication, we seek to determine if the adoption and use of the tool might narrow the differences between patient groups.
RESULTS


The trial was funded in November 2017 and received local ethics review approval in February 2019. The study began recruitment in April 2019 and enrollment concluded in October 2019 with 301 participants. The analysis was completed in May 2020, and trial results are expected to be published in winter 2020.
CONCLUSIONS


Recently, there has been increased attention to the role of health information technology tools to enable patients to collaborate with providers through the sharing of PCD. The adoption of such tools may overcome the barriers of current EHRs by directly engaging patients to submit their contextual data. Effectively, these tools would support the EHR in providing a more holistic understanding of the patient. Research further supports that individuals who have robust digital engagement using consumer informatics tools have higher participation in treatment follow-up and self-care across populations. Therefore, it is critical to investigate interventions that elicit and share patients' social risks and care preferences with the health care team as a mechanism to improve individualized care and reduce the gap in health outcomes.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03766841; https://clinicaltrials.gov/ct2/show/NCT03766841.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


RR1-10.2196/20309.",2020,Research further supports that individuals who have robust digital engagement using consumer informatics tools have higher participation in treatment follow-up and self-care across populations.,"['patient users and patient nonusers of an', 'Black and White patients', 'non-Hispanic White and Black patients who receive primary care services at a midwestern academic health care system in the United States', 'April 2019 and enrollment concluded in October 2019 with 301 participants']","['electronic health record (EHR)-integrated PCD tool', 'PCD', 'Previsit Contextual Data Collection']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0018696', 'cui_str': 'Healthcare Systems'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0917903', 'cui_str': 'Conclude Composite Resin'}]","[{'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}]",[],,0.102701,Research further supports that individuals who have robust digital engagement using consumer informatics tools have higher participation in treatment follow-up and self-care across populations.,"[{'ForeName': 'Jeana M', 'Initials': 'JM', 'LastName': 'Holt', 'Affiliation': 'College of Nursing, University of Wisconsin-Milwaukee, Milwaukee, WI, United States.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Cusatis', 'Affiliation': 'Hematology and Oncology Department of Medicine, Medical College of Wisconsin, Milwaukee, WI, United States.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Winn', 'Affiliation': 'School of Pharmacy, Medical College of Wisconsin, Milwaukee, WI, United States.'}, {'ForeName': 'Onur', 'Initials': 'O', 'LastName': 'Asan', 'Affiliation': 'School of Systems and Enterprises, Stevens Institute of Technology, Hoboken, NJ, United States.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Spanbauer', 'Affiliation': 'Institute for Health and Equity, Medical College of Wisconsin, Milwaukee, WI, United States.'}, {'ForeName': 'Joni S', 'Initials': 'JS', 'LastName': 'Williams', 'Affiliation': 'Department of Medicine, Medical College of Wisconsin, Center for Advancing Population Science, Milwaukee, WI, United States.'}, {'ForeName': 'Kathryn E', 'Initials': 'KE', 'LastName': 'Flynn', 'Affiliation': 'Department of Medicine, Medical College of Wisconsin, Milwaukee, WI, United States.'}, {'ForeName': 'Melek', 'Initials': 'M', 'LastName': 'Somai', 'Affiliation': 'Department of Medicine, Medical College of Wisconsin, Milwaukee, WI, United States.'}, {'ForeName': 'Purushottam', 'Initials': 'P', 'LastName': 'Laud', 'Affiliation': 'Institute for Health and Equity, Medical College of Wisconsin, Milwaukee, WI, United States.'}, {'ForeName': 'Bradley H', 'Initials': 'BH', 'LastName': 'Crotty', 'Affiliation': 'Department of Medicine, Medical College of Wisconsin, Milwaukee, WI, United States.'}]",JMIR research protocols,['10.2196/20309']
2864,32965224,SMS Text Messages for Parents for the Prevention of Child Drowning in Bangladesh: Acceptability Study.,"BACKGROUND


In many cases, greater use is being made of mobile phone text messages as a means of communication between patients and health care providers in countries around the world.
OBJECTIVE


We studied the use of mobile phones and the factors related to the acceptability of text messages for parents for the prevention of child drowning in Bangladesh.
METHODS


From a randomized controlled trial involving 800 parents, 10% (80/800) were selected, and socioeconomic status, mobile phone use, and acceptability of SMS text messages for drowning prevention were measured. Participants with at least one child under 5 years of age were selected from rural areas in Rajshahi District in Bangladesh. Mobile phone-based SMS text messages were sent to the participants. Multivariate regression was used to determine the factors related to the acceptability of text messages for the prevention of child drowning in Bangladesh.
RESULTS


The acceptability of SMS text messages for the prevention of child drowning in Bangladesh was significantly lower among women (odds ratio [OR] 0.50, 95% CI 0.12-1.96, P=.02) than among men, lower for parents older than 30 years (OR 0.17, 95% CI 0.14-1.70, P=.01) compared to parents younger than 30 years, higher among parents who had an education (OR 1.63, 95% CI 1.11-5.80, P=.04) than among illiterate parents, and higher among parents with a monthly household income over 7000 Bangladeshi Taka (approximately US $82.54; OR 1.27, 95% CI 1.06-1.96, P=.05) than among parents whose monthly income was less than 7000 Bangladeshi Taka.
CONCLUSIONS


The high percentage of mobile phone use and the acceptability of SMS text messages for parents for the prevention of child drowning are encouraging, in terms of identifying the best strategy for using such technologies, and deserve further evaluation.",2020,"Multivariate regression was used to determine the factors related to the acceptability of text messages for the prevention of child drowning in Bangladesh.
","['Parents for the Prevention of Child Drowning in Bangladesh', '800 parents, 10% (80/800) were selected, and socioeconomic status, mobile phone use, and acceptability of SMS text messages for drowning prevention were measured', 'parents for the prevention of child drowning in Bangladesh', 'patients and health care providers in countries around the world', 'Participants with at least one child under 5 years of age were selected from rural areas in Rajshahi District in Bangladesh']",[],[],"[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0013142', 'cui_str': 'Drowning'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0086996', 'cui_str': 'Socioeconomic Status'}, {'cui': 'C4505320', 'cui_str': 'Mobile Phone Use'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]",[],[],800.0,0.136981,"Multivariate regression was used to determine the factors related to the acceptability of text messages for the prevention of child drowning in Bangladesh.
","[{'ForeName': 'Md Mosharaf', 'Initials': 'MM', 'LastName': 'Hossain', 'Affiliation': 'Faculty of Business, Economics and Social Development, Universiti Malaysia Terengganu, Kuala Nerus, Terengganu, Malaysia.'}, {'ForeName': 'Kulanthayan', 'Initials': 'K', 'LastName': 'Mani', 'Affiliation': 'Safe Kids Malaysia and Department of Community Health, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Selangor, Malaysia.'}, {'ForeName': 'Ruhani', 'Initials': 'R', 'LastName': 'Mat Min', 'Affiliation': 'Faculty of Business, Economics and Social Development, Universiti Malaysia Terengganu, Kuala Nerus, Terengganu, Malaysia.'}]",JMIR mHealth and uHealth,['10.2196/16958']
2865,32975529,Electronic Health Record Portal Messages and Interactive Voice Response Calls to Improve Rates of Early Season Influenza Vaccination: Randomized Controlled Trial.,"BACKGROUND


Patient reminders for influenza vaccination, delivered via an electronic health record patient portal and interactive voice response calls, offer an innovative approach to engaging patients and improving patient care.
OBJECTIVE


The goal of this study was to test the effectiveness of portal and interactive voice response outreach in improving rates of influenza vaccination by targeting patients in early September, shortly after vaccinations became available.
METHODS


Using electronic health record portal messages and interactive voice response calls promoting influenza vaccination, outreach was conducted in September 2015. Participants included adult patients within a large multispecialty group practice in central Massachusetts. Our main outcome was electronic health record-documented early influenza vaccination during the 2015-2016 influenza season, measured in November 2015. We randomly assigned all active portal users to 1 of 2 groups: (1) receiving a portal message promoting influenza vaccinations, listing upcoming clinics, and offering online scheduling of vaccination appointments (n=19,506) or (2) receiving usual care (n=19,505). We randomly assigned all portal nonusers to 1 of 2 groups: (1) receiving interactive voice response call (n=15,000) or (2) receiving usual care (n=43,596). The intervention also solicited patient self-reports on influenza vaccinations completed outside the clinic. Self-reported influenza vaccination data were uploaded into the electronic health records to increase the accuracy of existing provider-directed electronic health record clinical decision support (vaccination alerts) but were excluded from main analyses.
RESULTS


Among portal users, 28.4% (5549/19,506) of those randomized to receive messages and 27.1% (5294/19,505) of the usual care group had influenza vaccinations documented by November 2015 (P=.004). In multivariate analysis of portal users, message recipients were slightly more likely to have documented vaccinations when compared to the usual care group (OR 1.07, 95% CI 1.02-1.12). Among portal nonusers, 8.4% (1262/15,000) of those randomized to receive calls and 8.2% (3586/43,596) of usual care had documented vaccinations (P=.47), and multivariate analysis showed nonsignificant differences. Over half of portal messages sent were opened (10,112/19,479; 51.9%), and over half of interactive voice response calls placed (7599/14,984; 50.7%) reached their intended target, thus we attained similar levels of exposure to the messaging for both interventions. Among portal message recipients, 25.4% of message openers (2570/10,112) responded to a subsequent question on receipt of influenza vaccination; among interactive voice response recipients, 72.5% of those reached (5513/7599) responded to a similar question.
CONCLUSIONS


Portal message outreach to a general primary care population achieved a small but statistically significant improvement in rates of influenza vaccination (OR 1.07, 95% CI 1.02-1.12). Interactive voice response calls did not significantly improve vaccination rates among portal nonusers (OR 1.03, 95% CI 0.96-1.10). Rates of patient engagement with both modalities were favorable.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02266277; https://clinicaltrials.gov/ct2/show/NCT02266277.",2020,"Interactive voice response calls did not significantly improve vaccination rates among portal nonusers (OR 1.03, 95% CI 0.96-1.10).","['Participants included adult patients within a large multispecialty group practice in central Massachusetts', 'Early Season Influenza Vaccination']","['interactive voice response call (n=15,000) or (2) receiving usual care (n=43,596', 'Electronic Health Record Portal Messages and Interactive Voice Response Calls', 'portal and interactive voice response outreach', 'portal message promoting influenza vaccinations, listing upcoming clinics, and offering online scheduling of vaccination appointments (n=19,506) or (2) receiving usual care (n=19,505']","['influenza vaccinations', 'rates of influenza vaccination', 'Interactive voice response calls', 'vaccination rates']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0018262', 'cui_str': 'Group Practice'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0042200', 'cui_str': 'Influenza vaccination'}]","[{'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0042200', 'cui_str': 'Influenza vaccination'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0205539', 'cui_str': 'Scheduled - procedure status'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}]","[{'cui': 'C0042200', 'cui_str': 'Influenza vaccination'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]",,0.404764,"Interactive voice response calls did not significantly improve vaccination rates among portal nonusers (OR 1.03, 95% CI 0.96-1.10).","[{'ForeName': 'Jessica G', 'Initials': 'JG', 'LastName': 'Wijesundara', 'Affiliation': 'Department of Population and Quantitative Health Sciences, University of Massachusetts Medical School, Worcester, MA, United States.'}, {'ForeName': 'Mayuko', 'Initials': 'M', 'LastName': 'Ito Fukunaga', 'Affiliation': 'Department of Population and Quantitative Health Sciences, University of Massachusetts Medical School, Worcester, MA, United States.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Ogarek', 'Affiliation': 'Center for Gerontology and Healthcare Research, Brown University, Providence, MA, United States.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Barton', 'Affiliation': 'Department of Population and Quantitative Health Sciences, University of Massachusetts Medical School, Worcester, MA, United States.'}, {'ForeName': 'Lloyd', 'Initials': 'L', 'LastName': 'Fisher', 'Affiliation': 'Department of Pediatrics, University of Massachusetts Medical School, Worcester, MA, United States.'}, {'ForeName': 'Peggy', 'Initials': 'P', 'LastName': 'Preusse', 'Affiliation': 'Reliant Medical Group, Worcester, MA, United States.'}, {'ForeName': 'Devi', 'Initials': 'D', 'LastName': 'Sundaresan', 'Affiliation': 'Reliant Medical Group, Worcester, MA, United States.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Garber', 'Affiliation': 'Meyers Primary Care Institute, Worcester, MA, United States.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Mazor', 'Affiliation': 'Meyers Primary Care Institute, Worcester, MA, United States.'}, {'ForeName': 'Sarah L', 'Initials': 'SL', 'LastName': 'Cutrona', 'Affiliation': 'Department of Population and Quantitative Health Sciences, University of Massachusetts Medical School, Worcester, MA, United States.'}]",Journal of medical Internet research,['10.2196/16373']
2866,32971179,"High-intensity interval training on body composition, functional capacity and biochemical markers in healthy young versus older people.","BACKGROUND


The aim of the following study was to identify the effects of a 12-week high-intensity interval training (HIIT) program on the modification of parameters of body composition, functional capacity as well as lipid and glucose homeostasis markers in healthy young people versus older adults.
DESIGN


Experimental trial.
METHODS


Healthy young (YNG, 21 ± 1 years, BMI 26.01 ± 2.64 kg·m -2 , n = 10) and older (OLD, 66 ± 5 years, BMI 27.43 ± 3.11 kg·m -2 , n = 10) males were subjected to 12 weeks of HIIT. Prior to and immediately after the HIIT program, dual-energy X-ray absorptiometry, dominant leg strength one-repetition maximum (1-RM), maximal oxygen uptake (VO 2max ) and physical performance tests were performed. Blood samples were also taken.
RESULTS


Flexibility (P = 0.000), static balance (P = 0.004), timed up and go test (TUG) (P = 0.015), short physical performance battery (SPPB) (P = 0.005), dominant leg strength 1-RM (P = 0.012), and VO 2max  (P = 0.000) were better in YNG versus OLD. HIIT improved the % whole-body fat mass (P = 0.031), leg lean mass (P = 0.047), dominant leg strength 1-RM (P = 0.025), VO 2max  (P = 0.000), fasting cholesterol (P = 0.017) and fasting glucose (P = 0.006). TUG was improved by the training only in the OLD group (P = 0.016), but insulin (P = 0.002) and the homeostasis model assessment - insulin sensitivity (HOMA-IS) (P = 0.000) decreased only in the YNG group. HOMA-IS was correlated positive with BMI (R = 0.474, P = 0.035) and with whole-body fat mass (R = 0.517, P = 0.019).
CONCLUSIONS


HIIT for 12 weeks improves parameters of body composition, functional capacity and fasting serum lipid and glucose homeostasis markers in healthy young and older participants. Young people are shown as benefiting more.",2020,"HIIT improved the 1-RM dominant leg strength (P = 0.025), VO 2max  (P = 0.000), % whole-body fat mass (P = 0.031), leg lean mass (P = 0.047), fasting cholesterol (P = 0.017) and fasting glucose (P = 0.006).","['Healthy young (YNG, 21\u202f±\u202f1\u202fyears, BMI 26.01\u202f±\u202f2.64, n\u202f=\u202f10) and older (OLD, 66\u202f±\u202f5\u202fyears, BMI 27.43\u202f±\u202f3.11, n\u202f=\u202f10) males', 'healthy young and older participants', 'healthy young versus older people', 'healthy young people vs older adults']","['high-intensity interval training (HIIT) program', 'High-intensity interval training']","['homeostasis model assessment - insulin sensitivity (HOMA-IS', 'HOMA-IS', 'repetition maximum (1-RM) dominant leg strength, maximal oxygen uptake (VO 2max ) and functional capacity tests', 'TUG', 'static balance', 'body composition, functional capacity and biochemical markers', 'body composition, functional capacity and fasting serum lipid and glucose homeostasis markers', 'Flexibility', 'leg lean mass', 'body composition, aerobic capacity, functional capacity as well as lipid and glucose homeostasis markers', 'timed up and go test (TUG', '1-RM dominant leg strength', 'physical performance', 'VO 2max', 'fasting cholesterol', 'fasting glucose']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C1829779', 'cui_str': 'Homeostasis model assessment'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0206015', 'cui_str': 'Biochemical Markers'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0428462', 'cui_str': 'Measurement of serum lipid level'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}]",,0.0125358,"HIIT improved the 1-RM dominant leg strength (P = 0.025), VO 2max  (P = 0.000), % whole-body fat mass (P = 0.031), leg lean mass (P = 0.047), fasting cholesterol (P = 0.017) and fasting glucose (P = 0.006).","[{'ForeName': 'Gabriel Nasri', 'Initials': 'GN', 'LastName': 'Marzuca-Nassr', 'Affiliation': 'Departamento de Medicina Interna, Facultad de Medicina, Universidad de La Frontera, Temuco, Chile; Magíster en Terapia Física con menciones, Facultad de Medicina, Universidad de La Frontera, Temuco, Chile. Electronic address: gabriel.marzuca@ufrontera.cl.'}, {'ForeName': 'Macarena', 'Initials': 'M', 'LastName': 'Artigas-Arias', 'Affiliation': 'Magíster en Terapia Física con menciones, Facultad de Medicina, Universidad de La Frontera, Temuco, Chile; Departamento de Procesos Terapéuticos, Facultad de Ciencias de la Salud, Universidad Católica de Temuco, Temuco, Chile.'}, {'ForeName': 'María Angélica', 'Initials': 'MA', 'LastName': 'Olea', 'Affiliation': 'Departamento de Educación Física, Deporte y Recreación, Facultad de Educación, Ciencias Sociales y Humanidades, Universidad de la Frontera, Temuco, Chile.'}, {'ForeName': 'Yuri', 'Initials': 'Y', 'LastName': 'SanMartín-Calísto', 'Affiliation': 'Magíster en Terapia Física con menciones, Facultad de Medicina, Universidad de La Frontera, Temuco, Chile.'}, {'ForeName': 'Nolberto', 'Initials': 'N', 'LastName': 'Huard', 'Affiliation': 'Centro de Biología Molecular y Farmacogenética, Departamento de Ciencias Básicas, Facultad de Medicina, Universidad de La Frontera, Temuco, Chile.'}, {'ForeName': 'Fernanda', 'Initials': 'F', 'LastName': 'Durán-Vejar', 'Affiliation': 'Carrera de Kinesiología, Facultad de Medicina, Universidad de La Frontera, Chile.'}, {'ForeName': 'Francisca', 'Initials': 'F', 'LastName': 'Beltrán-Fuentes', 'Affiliation': 'Carrera de Kinesiología, Facultad de Medicina, Universidad de La Frontera, Chile.'}, {'ForeName': 'Aris', 'Initials': 'A', 'LastName': 'Muñoz-Fernández', 'Affiliation': 'Carrera de Kinesiología, Facultad de Medicina, Universidad de La Frontera, Chile.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Alegría-Molina', 'Affiliation': 'Magíster en Terapia Física con menciones, Facultad de Medicina, Universidad de La Frontera, Temuco, Chile.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Sapunar', 'Affiliation': 'Departamento de Medicina Interna, Facultad de Medicina, Universidad de La Frontera, Temuco, Chile.'}, {'ForeName': 'Luis A', 'Initials': 'LA', 'LastName': 'Salazar', 'Affiliation': 'Centro de Biología Molecular y Farmacogenética, Departamento de Ciencias Básicas, Facultad de Medicina, Universidad de La Frontera, Temuco, Chile.'}]",Experimental gerontology,['10.1016/j.exger.2020.111096']
2867,32971253,Effects of 13-valent pneumococcal conjugate vaccination of adults on lower respiratory tract infections and antibiotic use in primary care: secondary analysis of a double-blind randomized placebo-controlled study.,"OBJECTIVES


The efficacy of 13-valent pneumococcal conjugate vaccine (PCV13) in adults to prevent community-acquired pneumonia (CAP) and lower respiratory tract infections (LRTI) not requiring hospitalization is unknown. We determined the effect of PCV13 on CAP, LRTI and antibiotic use in the primary care setting.
METHODS


Community-dwelling immunocompetent adults over 65 years of age were randomized to PCV13 or placebo as part of the double-blind Community-Acquired Pneumonia immunization Trial in Adults (CAPiTA). CAP and LRTI episodes and antibiotic prescription data were extracted from general practitioner information systems of 40 426 individuals. Vaccine efficacy (VE) of PCV13 was determined using Poisson regression with robust standard errors, comparing CAP and non-CAP LRTI episodes, LRTI-specific and total antibiotic prescriptions.
RESULTS


In all, 20 195 participants received PCV13 and 20 231 received placebo. A total of 1564 and 1659 CAP episodes occurred in the PCV13 and placebo group, respectively; VE 5.5% (95% CI -2.6% to 13.0%). Non-CAP LRTI episodes occurred 7535 and 7817 times in the PCV13 and placebo groups, respectively; VE 3.4% (95% CI -2.0% to 8.5%). A total of 8835 and 9245 LRTI-related antibiotic courses were prescribed in the PCV13 and placebo arms, respectively; VE 4.2% (95% CI -1.0% to 9.1%). Antibiotic courses for any indication were prescribed 43 386 and 43 309 times, respectively; VE -0.4% (-4.9% to 3.9%).
CONCLUSIONS


PCV13 vaccination in the elderly is unlikely to cause a relevant reduction in the incidence of CAP, LRTI, LRTI-related antibiotic use or total antibiotic use in primary care.",2020,"CAP LRTI episodes occurred 7,535 and 7,817 times in the PCV13 and placebo group, respectively; VE (95% CI): 3.4% (-2.0% - 8.5%).","['Community-dwelling immunocompetent adults over 65\xa0years of age', 'adults on lower respiratory tract infections and antibiotic use in primary care', 'adults to prevent community-acquired pneumonia (CAP) and lower respiratory tract infections (LRTI', '40,426 subjects']","['PCV13 or placebo', '13-valent pneumococcal conjugate vaccine (PCV13', '13-valent Pneumococcal Conjugate Vaccination', 'PCV13 and 20,231 placebo', 'PCV13', 'placebo', 'PCV13 vaccination']","['CAP, LRTI, and antibiotic use', 'CAP LRTI episodes', 'Vaccine efficacy (VE) of PCV13']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0149725', 'cui_str': 'Lower respiratory tract infection'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0694549', 'cui_str': 'Community acquired pneumonia'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3152625', 'cui_str': 'Pneumococcal 13-valent conjugate vaccine'}, {'cui': 'C3661918', 'cui_str': 'Pneumococcal conjugate vaccination'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0694549', 'cui_str': 'Community acquired pneumonia'}, {'cui': 'C0149725', 'cui_str': 'Lower respiratory tract infection'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.572271,"CAP LRTI episodes occurred 7,535 and 7,817 times in the PCV13 and placebo group, respectively; VE (95% CI): 3.4% (-2.0% - 8.5%).","[{'ForeName': 'Cornelis H', 'Initials': 'CH', 'LastName': 'van Werkhoven', 'Affiliation': 'Julius Centre for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht University, the Netherlands. Electronic address: c.h.vanwerkhoven@umcutrecht.nl.'}, {'ForeName': 'Marieke', 'Initials': 'M', 'LastName': 'Bolkenbaas', 'Affiliation': 'Julius Centre for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht University, the Netherlands.'}, {'ForeName': 'Susanne M', 'Initials': 'SM', 'LastName': 'Huijts', 'Affiliation': 'Julius Centre for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht University, the Netherlands; Department of Respiratory Medicine, Erasmus Medical Centre, Rotterdam, the Netherlands.'}, {'ForeName': 'Theo J M', 'Initials': 'TJM', 'LastName': 'Verheij', 'Affiliation': 'Julius Centre for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht University, the Netherlands.'}, {'ForeName': 'Marc J M', 'Initials': 'MJM', 'LastName': 'Bonten', 'Affiliation': 'Julius Centre for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht University, the Netherlands; Department of Medical Microbiology, University Medical Centre Utrecht, Utrecht University, the Netherlands.'}]",Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases,['10.1016/j.cmi.2020.09.011']
2868,32971262,Another's pain in my brain: No evidence that placebo analgesia affects the sensory-discriminative component in empathy for pain.,"The shared representations account of empathy suggests that sharing other people's emotions relies on neural processes similar to those engaged when directly experiencing such emotions. Recent research corroborated this by showing that placebo analgesia induced for first-hand pain resulted in reduced pain empathy and decreased activation in shared neural networks. However, those studies did not report any placebo-related variation of somatosensory engagement during pain empathy. The experimental paradigms used in these studies did not direct attention towards a specific body part in pain, which may explain the absence of effects for somatosensation. The main objective of this preregistered study was to implement a paradigm overcoming this limitation, and to investigate whether placebo analgesia may also modulate the sensory-discriminative component of empathy for pain. We induced a localized, first-hand placebo analgesia effect in the right hand of 45 participants by means of a placebo gel and conditioning techniques, and compared this to the left hand as a control condition. Participants underwent a pain task in the MRI scanner, receiving painful or non-painful electrical stimulation on their left or right hand, or witnessing another person receiving such stimulation. In contrast to a robust localized placebo analgesia effect for self-experienced pain, the empathy condition showed no differences between the two hands, neither for behavioral nor neural responses. We thus report no evidence for somatosensory sharing in empathy, while replicating previous studies showing overlapping brain activity in the affective-motivational component for first-hand and empathy for pain. Hence, in a more rigorous test aiming to overcome limitations of previous work, we again find no causal evidence for the engagement of somatosensory sharing in empathy. Our study refines the understanding of the neural underpinnings of empathy for pain, and the use of placebo analgesia in investigating such models.",2020,"In contrast to a robust localized placebo analgesia effect for self-experienced pain, the empathy condition showed no differences between the two hands, neither for behavioral nor neural responses.","[""Another's pain in my brain"", '45 participants by means of a']","['placebo', 'pain task in the MRI scanner, receiving painful or non-painful electrical stimulation on their left or right hand, or witnessing another person receiving such stimulation', 'placebo gel and conditioning techniques']","['behavioral nor neural responses', 'pain empathy']","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0183115', 'cui_str': 'Scanner'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0230370', 'cui_str': 'Structure of right hand'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}]",45.0,0.195586,"In contrast to a robust localized placebo analgesia effect for self-experienced pain, the empathy condition showed no differences between the two hands, neither for behavioral nor neural responses.","[{'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Hartmann', 'Affiliation': 'Social, Cognitive and Affective Neuroscience Unit, Department of Cognition, Emotion, and Methods in Psychology, Faculty of Psychology, University of Vienna, Liebiggasse 5, 1010 Vienna, Austria.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Rütgen', 'Affiliation': 'Social, Cognitive and Affective Neuroscience Unit, Department of Cognition, Emotion, and Methods in Psychology, Faculty of Psychology, University of Vienna, Liebiggasse 5, 1010 Vienna, Austria.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Riva', 'Affiliation': 'Social, Cognitive and Affective Neuroscience Unit, Department of Cognition, Emotion, and Methods in Psychology, Faculty of Psychology, University of Vienna, Liebiggasse 5, 1010 Vienna, Austria.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Lamm', 'Affiliation': 'Social, Cognitive and Affective Neuroscience Unit, Department of Cognition, Emotion, and Methods in Psychology, Faculty of Psychology, University of Vienna, Liebiggasse 5, 1010 Vienna, Austria. Electronic address: claus.lamm@univie.ac.at.'}]",NeuroImage,['10.1016/j.neuroimage.2020.117397']
2869,32971964,Gaelic4Girls-The Effectiveness of a 10-Week Multicomponent Community Sports-Based Physical Activity Intervention for 8 to 12-Year-Old Girls.,"Girls are less active than boys throughout childhood and adolescence, with limited research focusing on female community sports-based programs. This study aims to assess the effectiveness of a multi-component, community sports-based intervention for increasing girl's physical activity (PA) levels, fundamental movement skill (FMS) proficiency, and psychological wellbeing, as relative to a second treatment group (the traditionally delivered national comparative program), and a third control group. One hundred and twenty female-only participants (mean age = 10.75 ± 1.44 years), aged 8 to 12 years old from three Ladies Gaelic Football (LGF) community sports clubs (rural and suburban) were allocated to one of three conditions: (1) Intervention Group 1 (n = 43) received a novel, specifically tailored, research-informed Gaelic4Girls (G4G) intervention; (2) Intervention Group 2 (n = 44) used the traditionally delivered, national G4G program, as run by the Ladies Gaelic Football (LGF) Association of Ireland; and (3) Control Group 3 (n = 33) received no G4G intervention (group 1 or 2) conditions and were expected to carry out their usual LGF community sports activities. Primary outcome measurements (at both pre- and 10-week follow up) examining the effectiveness of the G4G intervention included (1) PA, (2) FMS and (3) Psychological correlates (enjoyment levels, self-efficacy, peer and parental support). Following a two (pre to post) by three (intervention group 1, intervention group 2, and control group 3) mixed-model ANOVA, it was highlighted that intervention group 1 significantly increased in PA ( p  = 0.003), FMS proficiency ( p  = 0.005) and several psychological correlates of PA ( p  ≤ 0.005). The findings demonstrate that the 10-week, specifically tailored, research-informed G4G intervention is a feasible and efficacious program, leading to a positive effect on the physical and psychological wellbeing of pre-adolescent Irish girls, relative to the traditionally delivered national G4G comparative program and control group conditions.",2020,"The findings demonstrate that the 10-week, specifically tailored, research-informed G4G intervention is a feasible and efficacious program, leading to a positive effect on the physical and psychological wellbeing of pre-adolescent Irish girls, relative to the traditionally delivered national G4G comparative program and control group conditions.","['One hundred and twenty female-only participants (mean age = 10.75 ± 1.44 years), aged 8 to 12 years old from three Ladies Gaelic Football (LGF) community sports clubs (rural and suburban', '8 to 12-Year-Old Girls']","['10-Week Multicomponent Community Sports-Based Physical Activity Intervention', 'traditionally delivered, national G4G program, as run by the Ladies Gaelic Football (LGF) Association of Ireland; and (3) Control Group 3 (n = 33) received no G4G intervention', 'novel, specifically tailored, research-informed Gaelic4Girls (G4G) intervention', 'multi-component, community sports-based intervention']","['effectiveness of the G4G intervention included (1) PA, (2) FMS and (3) Psychological correlates (enjoyment levels, self-efficacy, peer and parental support', ""girl's physical activity (PA) levels, fundamental movement skill (FMS) proficiency, and psychological wellbeing"", 'several psychological correlates of PA', 'FMS proficiency']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0574307', 'cui_str': 'Scottish Gaelic language'}, {'cui': 'C0016517', 'cui_str': 'American or Canadian football - sport'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0149651', 'cui_str': 'Clubbing'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0574307', 'cui_str': 'Scottish Gaelic language'}, {'cui': 'C0016517', 'cui_str': 'American or Canadian football - sport'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0022067', 'cui_str': 'Republic of Ireland'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0700287', 'cui_str': 'Informing'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0449432', 'cui_str': 'Component'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0418946', 'cui_str': 'Parental support'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]",,0.0183106,"The findings demonstrate that the 10-week, specifically tailored, research-informed G4G intervention is a feasible and efficacious program, leading to a positive effect on the physical and psychological wellbeing of pre-adolescent Irish girls, relative to the traditionally delivered national G4G comparative program and control group conditions.","[{'ForeName': 'Orlagh', 'Initials': 'O', 'LastName': 'Farmer', 'Affiliation': 'Sports Studies and Physical Education Program, School of Education, 2 Lucan Place, Western Road, 0000 Cork, Ireland.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Cahill', 'Affiliation': 'School of Education, Postgraduate Diploma in Special Educational Needs, University College Cork, 0000 Cork, Ireland.'}, {'ForeName': 'Wesley', 'Initials': 'W', 'LastName': ""O'Brien"", 'Affiliation': 'Sports Studies and Physical Education Program, School of Education, 2 Lucan Place, Western Road, 0000 Cork, Ireland.'}]",International journal of environmental research and public health,['10.3390/ijerph17186928']
2870,32971991,KiwiC for Vitality: Results of a Randomized Placebo-Controlled Trial Testing the Effects of Kiwifruit or Vitamin C Tablets on Vitality in Adults with Low Vitamin C Levels.,"Consumption of vitamin C-rich fruit and vegetables has been associated with greater feelings of vitality. However, these associations have rarely been tested in randomized controlled trials. The aim of the current study was to test the effects of eating a vitamin C-rich food (kiwifruit) on subjective vitality and whether effects are driven by vitamin C. Young adults ( n  = 167, 61.1% female, aged 18-35) with plasma vitamin C <40 µmol/L were randomized into three intervention conditions: kiwifruit (2 SunGold™ kiwifruit/day), vitamin C (250 mg tablet/day), placebo (1 tablet/day). The trial consisted of a two-week lead-in, four-week intervention, and two-week washout. Plasma vitamin C and vitality questionnaires (total mood disturbance, fatigue, and well-being) were measured fortnightly. Self-reported sleep quality and physical activity were measured every second day through smartphone surveys. Nutritional confounds were assessed using a three-day food diary during each study phase. Plasma vitamin C reached saturation levels within two weeks for the kiwifruit and vitamin C groups. Participants consuming kiwifruit showed significantly improved mood and well-being during the intervention period; improvements in well-being were sustained during washout. Decreased fatigue and increased well-being were observed following intake of vitamin C alone, but only for participants with consistently low vitamin C levels during lead-in. Diet records showed that participants consuming kiwifruit reduced their fat intake during the intervention period. Intervention effects remained significant when adjusting for age and ethnicity, and were not explained by sleep quality, physical activity, BMI, or other dietary patterns, including fat intake. There were no changes in plasma vitamin C status or vitality in the placebo group. Whole food consumption of kiwifruit improved subjective vitality in adults with low vitamin C status. Similar, but not identical, changes were found for vitamin C tablets suggesting that additional properties of kiwifruit may contribute to improved vitality.",2020,"Intervention effects remained significant when adjusting for age and ethnicity, and were not explained by sleep quality, physical activity, BMI, or other dietary patterns, including fat intake.","['KiwiC for Vitality', 'Young adults ( n  = 167, 61.1% female, aged 18-35) with plasma vitamin C <40 µmol/L', 'adults with low vitamin C status', 'Adults with Low Vitamin C Levels']","['intervention conditions: kiwifruit (2 SunGold™ kiwifruit/day), vitamin C', 'Kiwifruit or Vitamin C Tablets', 'eating a vitamin C-rich food (kiwifruit', 'placebo', 'Placebo', 'vitamin C-rich fruit and vegetables', 'vitamin C']","['Plasma vitamin C and vitality questionnaires (total mood disturbance, fatigue, and well-being', 'plasma vitamin C status or vitality', 'fat intake', 'Self-reported sleep quality and physical activity', 'Plasma vitamin C reached saturation levels', 'sleep quality, physical activity, BMI, or other dietary patterns, including fat intake', 'Decreased fatigue', 'subjective vitality']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C4517595', 'cui_str': '167'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0971874', 'cui_str': 'Actinidia deliciosa'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C0453861', 'cui_str': 'Rich food'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C2939186', 'cui_str': 'Disturbance in mood'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0522534', 'cui_str': 'Saturated'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}]",,0.202544,"Intervention effects remained significant when adjusting for age and ethnicity, and were not explained by sleep quality, physical activity, BMI, or other dietary patterns, including fat intake.","[{'ForeName': 'Tamlin S', 'Initials': 'TS', 'LastName': 'Conner', 'Affiliation': 'Department of Psychology, University of Otago, Dunedin 9054, New Zealand.'}, {'ForeName': 'Benjamin D', 'Initials': 'BD', 'LastName': 'Fletcher', 'Affiliation': 'Department of Psychology, University of Otago, Dunedin 9054, New Zealand.'}, {'ForeName': 'Juliet M', 'Initials': 'JM', 'LastName': 'Pullar', 'Affiliation': 'Centre for Free Radical Research, Department of Pathology and Biomedical Science, University of Otago, Christchurch 8140, New Zealand.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Spencer', 'Affiliation': 'Department of Pathology and Biomedical Science, University of Otago, Christchurch 8140, New Zealand.'}, {'ForeName': 'Louise A', 'Initials': 'LA', 'LastName': 'Mainvil', 'Affiliation': 'Department of Human Nutrition, University of Otago, Dunedin 9054, New Zealand.'}, {'ForeName': 'Margreet C M', 'Initials': 'MCM', 'LastName': 'Vissers', 'Affiliation': 'Centre for Free Radical Research, Department of Pathology and Biomedical Science, University of Otago, Christchurch 8140, New Zealand.'}]",Nutrients,['10.3390/nu12092898']
2871,32973429,Entraining Alpha Activity Using Visual Stimulation in Patients With Chronic Musculoskeletal Pain: A Feasibility Study.,"Entraining alpha activity with rhythmic visual, auditory, and electrical stimulation can reduce experimentally induced pain. However, evidence for alpha entrainment and pain reduction in patients with chronic pain is limited. This feasibility study investigated whether visual alpha stimulation can increase alpha power in patients with chronic musculoskeletal pain and, secondarily, if chronic pain was reduced following stimulation. In a within-subject design, 20 patients underwent 4-min periods of stimulation at 10 Hz (alpha), 7 Hz (high-theta, control), and 1 Hz (control) in a pseudo-randomized order. Patients underwent stimulation both sitting and standing and verbally rated their pain before and after each stimulation block on a 0-10 numerical rating scale. Global alpha power was significantly higher during 10 Hz compared to 1 Hz stimulation when patients were standing ( t  = -6.08,  p  < 0.001). On a more regional level, a significant increase of alpha power was found for 10 Hz stimulation in the right-middle and left-posterior region when patients were sitting. With respect to our secondary aim, no significant reduction of pain intensity and unpleasantness was found. However, only the alpha stimulation resulted in a minimal clinically important difference in at least 50% of participants for pain intensity (50%) and unpleasantness ratings (65%) in the sitting condition. This study provides initial evidence for the potential of visual stimulation as a means to enhance alpha activity in patients with chronic musculoskeletal pain. The brief period of stimulation was insufficient to reduce chronic pain significantly. This study is the first to provide evidence that a brief period of visual stimulation at alpha frequency can significantly increase alpha power in patients with chronic musculoskeletal pain. A further larger study is warranted to investigate optimal dose and individual stimulation parameters to achieve pain relief in these patients.",2020,"Global alpha power was significantly higher during 10 Hz compared to 1 Hz stimulation when patients were standing ( t  = -6.08,  ","['20 patients underwent', 'patients with chronic musculoskeletal pain', 'Patients With Chronic Musculoskeletal Pain', 'patients with chronic pain']","['rhythmic visual, auditory, and electrical stimulation', 'visual alpha stimulation', '4-min periods of stimulation at 10 Hz (alpha), 7 Hz (high-theta, control), and 1 Hz (control', 'Entraining Alpha Activity Using Visual Stimulation']","['unpleasantness ratings', 'pain intensity', 'pain relief', 'chronic pain', 'Global alpha power', 'alpha power', 'pain intensity and unpleasantness']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0746683', 'cui_str': 'Chronic musculoskeletal pain'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0591126', 'cui_str': 'AT-10'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0031734', 'cui_str': 'Photic stimulation'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}]",20.0,0.0579999,"Global alpha power was significantly higher during 10 Hz compared to 1 Hz stimulation when patients were standing ( t  = -6.08,  ","[{'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Arendsen', 'Affiliation': 'Division of Functional and Restorative Neurosurgery, Eberhart Karls University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Henshaw', 'Affiliation': 'Human Pain Research Group, Division of Neuroscience and Experimental Psychology, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Christopher A', 'Initials': 'CA', 'LastName': 'Brown', 'Affiliation': 'Human Pain Research Group, Division of Neuroscience and Experimental Psychology, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Manoj', 'Initials': 'M', 'LastName': 'Sivan', 'Affiliation': 'Human Pain Research Group, Division of Neuroscience and Experimental Psychology, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Jason R', 'Initials': 'JR', 'LastName': 'Taylor', 'Affiliation': 'Human Pain Research Group, Division of Neuroscience and Experimental Psychology, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Nelson J', 'Initials': 'NJ', 'LastName': 'Trujillo-Barreto', 'Affiliation': 'Human Pain Research Group, Division of Neuroscience and Experimental Psychology, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Alexander J', 'Initials': 'AJ', 'LastName': 'Casson', 'Affiliation': 'Department of Electrical and Electronic Engineering, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Anthony K P', 'Initials': 'AKP', 'LastName': 'Jones', 'Affiliation': 'Human Pain Research Group, Division of Neuroscience and Experimental Psychology, University of Manchester, Manchester, United Kingdom.'}]",Frontiers in neuroscience,['10.3389/fnins.2020.00828']
2872,32974044,"Mood, Activity Participation, and Leisure Engagement Satisfaction (MAPLES): a randomised controlled pilot feasibility trial for low mood in acquired brain injury.","Background


Acquired brain injury (ABI) affects approximately 79.3 million individuals annually and is linked with elevated rates of depression and low mood. Existing methods for treating depression in ABI have shown mixed efficacy. Behavioural activation (BA) is a potentially promising intervention. Its premise is that individuals with low mood avoid planning and engaging in activities due to low expectations of a positive outcome. Consequently, their exposure to positive reinforcement is reduced, exacerbating low mood. BA aims to break this cycle by encouraging activity planning and engagement. It is unknown whether cognitive demands of traditional BA may undermine efficacy in ABI. Here, we assess the feasibility and acceptability of two groups designed to increase activity engagement. In the activity planning group (traditional BA), the importance of meaningful and positive activity will be discussed and participants encouraged to plan/engage in activities in everyday life. The activity engagement group (experiential BA) instead focuses on engagement in positive experiences (crafts, games, discussion)  within  the group. The primary aims are to evaluate the feasibility and acceptability of the two groups in ABI. A secondary aim is to explore relative efficacy of the groups compared to an equivalent period of waitlist controls.
Method


This study outlines a parallel-arm pilot feasibility trial for individuals with low mood and ABI that compares a traditional vs experiential BA group vs waitlist controls. Adults (≥ 18 years) will be recruited from local ABI services and randomised to condition. Feasibility and acceptability will be assessed via recruitment, retention, attendance and participant feedback. Groups will be compared (pre- and post-intervention and 1 month follow-up) by assessing self-reported activity engagement. Secondary outcomes include self-report measures of depression, anxiety, post-traumatic distress related to the ABI, motivation, participation and sense of control over one's life.
Ethics and dissemination


The trial has been approved by the Health Research Authority of the NHS in the UK (East of England-Cambridge Central, REF 18/EE/0305). Results will inform future research on interventions for mood in ABI and be disseminated broadly via peer-reviewed journals, conference presentations and social media.
Trial registration


ClinicalTrials.gov, NCT03874650 pre-results. Protocol version 2.1, March 5, 2019.",2020,This study outlines a parallel-arm pilot feasibility trial for individuals with low mood and ABI that compares a traditional vs experiential BA group vs waitlist controls.,"['individuals with low mood and ABI that compares a traditional vs experiential BA group vs waitlist controls', 'Adults (≥\u200918\u2009years']","['activity engagement group (experiential BA', 'activity planning group (traditional BA']","['Mood, Activity Participation, and Leisure Engagement Satisfaction (MAPLES', 'Feasibility and acceptability', ""self-report measures of depression, anxiety, post-traumatic distress related to the ABI, motivation, participation and sense of control over one's life"", 'Behavioural activation (BA', 'feasibility and acceptability', 'activity engagement']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0270611', 'cui_str': 'Brain injury'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}]","[{'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0086542', 'cui_str': 'Leisure'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0330996', 'cui_str': 'Genus Acer'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0270611', 'cui_str': 'Brain injury'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0021783', 'cui_str': 'External-Internal Control'}, {'cui': 'C0376558', 'cui_str': 'Life'}]",,0.123716,This study outlines a parallel-arm pilot feasibility trial for individuals with low mood and ABI that compares a traditional vs experiential BA group vs waitlist controls.,"[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Kusec', 'Affiliation': 'MRC Cognition and Brain Sciences Unit, University of Cambridge, 15 Chaucer Road, Cambridge, CB2 7EF UK.'}, {'ForeName': 'Fionnuala C', 'Initials': 'FC', 'LastName': 'Murphy', 'Affiliation': 'MRC Cognition and Brain Sciences Unit, University of Cambridge, 15 Chaucer Road, Cambridge, CB2 7EF UK.'}, {'ForeName': 'Polly V', 'Initials': 'PV', 'LastName': 'Peers', 'Affiliation': 'MRC Cognition and Brain Sciences Unit, University of Cambridge, 15 Chaucer Road, Cambridge, CB2 7EF UK.'}, {'ForeName': 'Cara', 'Initials': 'C', 'LastName': 'Lawrence', 'Affiliation': 'Evelyn Community Head Injury Services, Cambridgeshire Community Services, Dynamic Health Building, Brookfields Hospital, 351 Mill Road, Cambridge, CB1 3DF UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Cameron', 'Affiliation': 'The National Hospital for Neurology and Neurosurgery, University College London Hospitals NHS Trust, Post Box 113, Queen Square, London, WC1N 3BG UK.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Morton', 'Affiliation': 'Evelyn Community Head Injury Services, Cambridgeshire Community Services, Dynamic Health Building, Brookfields Hospital, 351 Mill Road, Cambridge, CB1 3DF UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Bateman', 'Affiliation': 'School of Health and Social Care, University of Essex, Wivenhoe Park, Colchester, CO4 3SQ UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Watson', 'Affiliation': 'MRC Cognition and Brain Sciences Unit, University of Cambridge, 15 Chaucer Road, Cambridge, CB2 7EF UK.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Manly', 'Affiliation': 'MRC Cognition and Brain Sciences Unit, University of Cambridge, 15 Chaucer Road, Cambridge, CB2 7EF UK.'}]",Pilot and feasibility studies,['10.1186/s40814-020-00660-8']
2873,32974838,"Direct comparison of two extended half-life PEGylated recombinant FVIII products: a randomized, crossover pharmacokinetic study in patients with severe hemophilia A.","An open-label, crossover randomized study was performed to compare the pharmacokinetics (PK) of damoctocog alfa pegol and rurioctocog alfa pegol, two recombinant factor VIII (FVIII) products indicated in patients with hemophilia A, both conjugated to polyethylene glycol to reduce clearance and extend time in circulation. Adult patients (N = 18) with severe hemophilia A (FVIII < 1 IU/dL), previously treated with any FVIII product for ≥ 150 exposure days, were randomized to receive a single 50 IU/kg infusion of damoctocog alfa pegol followed by rurioctocog alfa pegol, or vice versa, with ≥ 7-day washout between doses. FVIII activity was measured using the one-stage clotting assay. PK parameters, including area under the curve from time 0 to the last data point (AUC 0-tlast , primary parameter), dose-normalized AUC (AUC norm ), and time to threshold, were calculated based on 11 time points between 0.25 and 120 h post-dose and evaluated using a noncompartmental model. Due to differences in batch-specific vial content used for the study, actual administered median doses were 54.3 IU/kg for damoctocog alfa pegol and 61.4 IU/kg for rurioctocog alfa pegol. Based on actual dosing, a significantly higher geometric mean (coefficient of variation [%CV]) AUC norm  was observed for damoctocog alfa pegol (43.8 h kg/dL [44.0]) versus rurioctocog alfa pegol (36.0 h kg/dL [40.1, P < 0.001]). Based on population PK modeling, median time to reach 1 IU/dL was 16 h longer for damoctocog alfa pegol compared with rurioctocog alfa pegol. No adverse events or any immunogenicity signals were observed. Overall, damoctocog alfa pegol had a superior PK profile versus rurioctocog alfa pegol. Trial registration number: NCT04015492 ( ClinicalTrials.gov identifier). Date of registration: July 9, 2019.",2020,dL was 16 h longer for damoctocog alfa pegol compared with rurioctocog alfa pegol.,"['Adult patients (N = 18) with severe hemophilia A', 'patients with severe hemophilia A', 'patients with hemophilia A']","['damoctocog alfa pegol and rurioctocog alfa pegol, two recombinant factor VIII ', 'two extended half-life PEGylated recombinant FVIII products']","['geometric mean (coefficient of variation [%CV', 'FVIII activity', 'PK parameters, including area under the curve from time 0 to the last data point (AUC 0-tlast , primary parameter), dose-normalized AUC (AUC norm ), and time to threshold']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0272322', 'cui_str': 'Severe hereditary factor VIII deficiency disease'}, {'cui': 'C0019069', 'cui_str': 'Hereditary factor VIII deficiency disease'}]","[{'cui': 'C4723219', 'cui_str': 'damoctocog alfa pegol'}, {'cui': 'C0795577', 'cui_str': 'recombinant antihemophilic factor VIII'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0018517', 'cui_str': 'Halflife'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0015506', 'cui_str': 'Factor VIII'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0237750', 'cui_str': 'Societal Norms'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}]",18.0,0.109307,dL was 16 h longer for damoctocog alfa pegol compared with rurioctocog alfa pegol.,"[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Solms', 'Affiliation': 'Clinical Pharmacometrics, Pharmaceuticals Research & Development, Bayer AG, 13353, Berlin, Germany. alexander.solms@bayer.com.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Shah', 'Affiliation': 'Bayer, Whippany, NJ, USA.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Berntorp', 'Affiliation': 'Centre for Thrombosis and Haemostasis, Lund University, Skåne University Hospital, Malmö, Sweden.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Tiede', 'Affiliation': 'Department of Hematology, Hemostasis, Oncology and Stem Cell Transplantation, Hannover Medical School, Hanover, Germany.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Iorio', 'Affiliation': 'McMaster-Bayer Endowed Research Chair in Clinical Epidemiology of Congenital Bleeding Disorders, Department of Medicine, McMaster University, Hamilton, Canada.'}, {'ForeName': 'Camila', 'Initials': 'C', 'LastName': 'Linardi', 'Affiliation': 'Bayer, Whippany, NJ, USA.'}, {'ForeName': 'Maurice', 'Initials': 'M', 'LastName': 'Ahsman', 'Affiliation': 'LAP&P Consultants BV, Leiden, the Netherlands.'}, {'ForeName': 'Maria Elisa', 'Initials': 'ME', 'LastName': 'Mancuso', 'Affiliation': 'Center for Thrombosis and Hemorrhagic Diseases, Humanitas Clinical and Research Center - IRCCS, Rozzano, Milan, Italy.'}, {'ForeName': 'Tihomir', 'Initials': 'T', 'LastName': 'Zhivkov', 'Affiliation': 'Specialized Hospital for Active Treatment, Sofia, Bulgaria.'}, {'ForeName': 'Toshko', 'Initials': 'T', 'LastName': 'Lissitchkov', 'Affiliation': 'Specialized Hospital for Active Treatment, Sofia, Bulgaria.'}]",Annals of hematology,['10.1007/s00277-020-04280-3']
2874,32949780,Induction of LTD-like corticospinal plasticity by low-frequency rTMS depends on pre-stimulus phase of sensorimotor μ-rhythm.,"BACKGROUND


Neural oscillations reflect rapidly changing brain excitability states. We have demonstrated previously with EEG-triggered transcranial magnetic stimulation (TMS) of human motor cortex that the positive vs. negative peak of the sensorimotor μ-oscillation reflect corticospinal low-vs. high-excitability states. In vitro experiments showed that induction of long-term depression (LTD) by low-frequency stimulation depends on the postsynaptic excitability state.
OBJECTIVE/HYPOTHESIS


We tested the hypothesis that induction of LTD-like corticospinal plasticity in humans by 1 Hz repetitive TMS (rTMS) is enhanced when rTMS is synchronized with the low-excitability state, but decreased or even shifted towards long-term (LTP)-like plasticity when synchronized with the high-excitability state.
METHODS


We applied real-time EEG-triggered 1-Hz-rTMS (900 pulses) to the hand area of motor cortex in healthy subjects. In a randomized double-blind three-condition crossover design, pulses were synchronized to either the positive or negative peak of the sensorimotor μ-oscillation, or were applied at random phase (control). The amplitude of motor evoked potentials was recorded as an index of corticospinal excitability before and after 1-Hz-rTMS.
RESULTS


1-Hz-rTMS at random phase resulted in a trend towards LTD-like corticospinal plasticity. RTMS in the positive peak condition (i.e., the low-excitability state) induced significant LTD-like plasticity. RTMS in the negative peak condition (i.e., the high-excitability state) showed a trend towards LTP-like plasticity, which was significantly different from the other two conditions.
CONCLUSION


The level of corticospinal depolarization reflected by phase of the μ-oscillation determines the degree of corticospinal plasticity induced by low-frequency rTMS, a finding that may guide future personalized therapeutic stimulation.",2020,"The amplitude of motor evoked potentials was recorded as an index of corticospinal excitability before and after 1-Hz-rTMS.
",['healthy subjects'],"['Hz repetitive TMS (rTMS', '1-Hz-rTMS', 'EEG-triggered transcranial magnetic stimulation (TMS']","['amplitude of motor evoked potentials', 'induction of long-term depression (LTD']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0032930', 'cui_str': 'Precipitating Factors'}]","[{'cui': 'C0282617', 'cui_str': 'Motor Evoked Potentials'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",,0.095784,"The amplitude of motor evoked potentials was recorded as an index of corticospinal excitability before and after 1-Hz-rTMS.
","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Baur', 'Affiliation': 'Department of Neurology & Stroke, University of Tübingen, Germany; Hertie-Institute for Clinical Brain Research, University of Tübingen, Germany.'}, {'ForeName': 'Dragana', 'Initials': 'D', 'LastName': 'Galevska', 'Affiliation': 'Department of Neurology & Stroke, University of Tübingen, Germany; Hertie-Institute for Clinical Brain Research, University of Tübingen, Germany.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Hussain', 'Affiliation': 'Human Cortical Physiology and Neurorehabilitation Section, National Institutes of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Leonardo G', 'Initials': 'LG', 'LastName': 'Cohen', 'Affiliation': 'Human Cortical Physiology and Neurorehabilitation Section, National Institutes of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Ziemann', 'Affiliation': 'Department of Neurology & Stroke, University of Tübingen, Germany; Hertie-Institute for Clinical Brain Research, University of Tübingen, Germany. Electronic address: ulf.ziemann@uni-tuebingen.de.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Zrenner', 'Affiliation': 'Department of Neurology & Stroke, University of Tübingen, Germany; Hertie-Institute for Clinical Brain Research, University of Tübingen, Germany.'}]",Brain stimulation,['10.1016/j.brs.2020.09.005']
2875,32949942,The effect of individualized education with support on breast cancer patients' anxiety and depression during radiation therapy: A pilot study.,"PURPOSE


This study was undertaken to determine the effects of individualized education with support intervention on breast cancer patients' anxiety and depression while undergoing radiation therapy (RT). Moreover, the intervention was assessed for its feasibility in the context of Pakistan.
METHODS


A quasi-experimental design was used to conduct this study in RT department of a public hospital in Karachi. A total of 61 breast cancer patients receiving radiation as adjuvant therapy participated in the study. The experimental group (n = 31) received individualized education with support in the form of face-to-face sessions and information booklet prior to the commencement of RT. In addition, the nurse remained available for the consultation during the RT sessions and on telephone throughout the RT period. However, the control group received only information booklet. Patients' anxiety and depression were measured in both of the groups before the commencement of RT, and at the completion of RT by using the Aga Khan University Anxiety and Depression Scale (AKUADS).
RESULTS


A significant reduction was found in the overall mean anxiety and depression scores of the experimental group (p = 0.000) from pre-test to post-test. The overall mean anxiety and depression scores of the control group showed no significant difference (p = 0.187). The effect size of the intervention was large (Cohen's d = 2.5).
CONCLUSION


The intervention was effective in reducing anxiety and depression among breast cancer patients receiving RT. Replication of the study on a larger scale in multiple settings on other cancer patients is recommended.",2020,A significant reduction was found in the overall mean anxiety and depression scores of the experimental group (p = 0.000) from pre-test to post-test.,"['61 breast cancer patients receiving radiation as adjuvant therapy participated in the study', ""breast cancer patients' anxiety and depression during radiation therapy"", ""breast cancer patients' anxiety and depression while undergoing radiation therapy (RT"", 'RT department of a public hospital in Karachi', 'breast cancer patients receiving RT']","['individualized education', 'individualized education with support intervention', 'individualized education with support in the form of face-to-face sessions and information booklet prior to the commencement of RT']","['overall mean anxiety and depression scores', 'anxiety and depression']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0020022', 'cui_str': 'Public Hospitals'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",61.0,0.0131595,A significant reduction was found in the overall mean anxiety and depression scores of the experimental group (p = 0.000) from pre-test to post-test.,"[{'ForeName': 'Shazia', 'Initials': 'S', 'LastName': 'Zaheer', 'Affiliation': 'Institute of Nursing, Combined Military Hospital (CMH) Lahore Medical College, Pakistan. Electronic address: shaziazaheer911@gmail.com.'}, {'ForeName': 'Raisa B', 'Initials': 'RB', 'LastName': 'Gul', 'Affiliation': 'Shifa Tameer-e-Millat University, Shifa College of Nursing, Islamabad, Pakistan.'}, {'ForeName': 'Shireen S', 'Initials': 'SS', 'LastName': 'Bhamani', 'Affiliation': 'Aga Khan University School of Nursing and Midwifery, Karachi, Pakistan.'}, {'ForeName': 'Muhammad A', 'Initials': 'MA', 'LastName': 'Memon', 'Affiliation': 'Atomic Energy Medical Center, Jinnah Post Graduate Medical Center, Karachi, Pakistan.'}]",European journal of oncology nursing : the official journal of European Oncology Nursing Society,['10.1016/j.ejon.2020.101826']
2876,32949954,A randomized control trial of meditation compared to music listening to improve cognitive function for breast cancer survivors: Feasibility and acceptability.,"BACKGROUND


and Purpose: Many breast cancer survivors (BCS) experience persistent cognitive and psychological changes associated with their cancer and/or treatment and that have limited treatment options. Therefore, the purpose of this study was to explore the feasibility and effects of a Kirtan Kriya meditation (KK) intervention on cognitive and psychological symptoms compared to an attention control condition, classical music listening (ML), in BCS.
MATERIALS AND METHODS


A randomized control trial design was used. Participants completed eight-week interventions. Cognitive function and psychological symptoms were measured at baseline and post-intervention. Mixed analysis of variance models were examined for all cognitive and psychological outcomes.
RESULTS


27 BCS completed the study. Intervention adherence was 88%. Both groups improved in perceived cognitive impairments, cognition related quality of life, verbal memory, and verbal fluency (p's < 0.01). There were no significant group by time effects for cognitive and psychological outcomes, except stress. The ML group reported lower stress at time 2 (p < 0.05).
CONCLUSION


KK and ML are feasible, acceptable, and cost-effective interventions that may be beneficial for survivors' cognition and psychological symptoms. Both interventions were easy to learn, low cost, and required just 12 min/day. Meditation or music listening could offer providers evidence-based suggestions to BCS experiencing cognitive symptoms.
CLINICAL TRIALS REGISTRATION NUMBER


NCT03696056.",2020,"Both groups improved in perceived cognitive impairments, cognition related quality of life, verbal memory, and verbal fluency (p's ",['breast cancer survivors'],"['Meditation or music listening', 'music listening', 'classical music listening (ML', 'Kirtan Kriya meditation (KK) intervention', 'meditation']","['cognitive and psychological symptoms', 'time effects for cognitive and psychological outcomes, except stress', ""perceived cognitive impairments, cognition related quality of life, verbal memory, and verbal fluency (p's"", 'cognitive function', 'Cognitive function and psychological symptoms', 'Intervention adherence']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0681251', 'cui_str': 'Classical Music'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0233397', 'cui_str': 'Psychological symptom'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",,0.062006,"Both groups improved in perceived cognitive impairments, cognition related quality of life, verbal memory, and verbal fluency (p's ","[{'ForeName': 'Ashley M', 'Initials': 'AM', 'LastName': 'Henneghan', 'Affiliation': 'The University of Texas at Austin, School of Nursing, 1710 Red River St, Austin, TX, 78712, USA; The University of Texas at Austin, Department of Oncology, 1601 Trinity St, Austin, TX, 78712, USA. Electronic address: ahenneghan@utexas.edu.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Becker', 'Affiliation': 'The University of Texas at Austin, School of Nursing, 1710 Red River St, Austin, TX, 78712, USA.'}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Harrison', 'Affiliation': 'The University of Texas at Austin, Kinesiology and Health Education, 2109 San Jacinto Blvd, Austin, TX, 78712, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Inselmann', 'Affiliation': 'Cancer Rehab and Integrative Medicine, 4130 Spicewood Springs Rd. Ste. 100, Austin, TX, 78759, USA.'}, {'ForeName': 'Brandon', 'Initials': 'B', 'LastName': 'Fico', 'Affiliation': 'The University of Texas at Austin, Kinesiology and Health Education, 2109 San Jacinto Blvd, Austin, TX, 78712, USA.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Schafer', 'Affiliation': 'The University of Texas at Austin, Dell Medical School, 1501 Red River Street St, Austin, TX, 78712, USA.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'King', 'Affiliation': 'Division of Clinical Cancer Genomics City of Hope, 1500 E. Duarte Road, Duarte, CA, 91010, USA.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Patt', 'Affiliation': 'Texas Oncology, The University of Texas at Austin, Department of Oncology, Dell Medical School, 1501 Red River Street St, Austin, TX, 78712, USA.'}, {'ForeName': 'Shelli', 'Initials': 'S', 'LastName': 'Kesler', 'Affiliation': 'The University of Texas at Austin, School of Nursing, 1710 Red River St, Austin, TX, 78712, USA; The University of Texas at Austin, Department of Diagnostic Medicine, 1601 Trinity St, Austin, TX, 78712, USA.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101228']
2877,32954762,The management of hemiplegic shoulder pain in stroke subjects undergoing pulsed radiofrequency treatment of the suprascapular and axillary nerves: a pilot study.,"BACKGROUND


Our trial aims to provide evidence for pain management and rehabilitation in patients with hemiplegic shoulder pain (HSP). HSP is one of the most common pains and disabilities occurring after a stroke. With accumulating evidence, the management of the suprascapular nerve (SSN) or axillary nerve (AN) might effectively relieve the pain and disability associated with HSP. However, no study has compared the effects of pulsed radiofrequency and nerve block of SSN and AN.
METHODS


Twenty patients with chronic stroke (over one year from onset) and HSP [visual analog scale (VAS) for pain ≥30 mm] randomly underwent ultrasound-guided SSN and AN pulsed radiofrequency or nerve block treatment. All patients were evaluated before treatment (T0) and at 4 (T1) and 16 (T2) weeks of follow-up. The primary outcome was the VAS score. Secondary outcomes were the Modified Ashworth Scale (MAS) score, passive shoulder range of motion (PROM), Disability Assessment Scale (DAS) score, and EuroQol-5 dimension questionnaire (EQ-5D).
RESULTS


Significant improvements in the VAS score were observed in both groups at T1 and T2. However, a significant difference was not observed between the two groups (T1: P=0.43; T2: P=0.23). No statistically significant differences were observed in the MAS score between the two groups at T1 (P=0.06) and T2 (P=0.07). In the PROM of shoulder abduction and external rotation, statistically, significant differences were observed between the two groups at T1 (P=0.02*, & P=0.04*) and T2 (P=0.02*, & P=0.00*). Statistically significant differences in shoulder flexion and extension were not observed between the two groups at T1 (P=0.23, & P=0.35) and T2 (P=0.14, & P=0.14). Statistically significant differences in the DAS score were not observed between the 2 groups at T1 (P=0.51, & P=0.33, & P=0.36, & P=0.75) and T2 (P=0.12, & P=0.54, & P=0.41, & P=0.86). No statistically significant differences in the EQ-5D responses were observed between the two groups at T1 (P=0.42) and T2 (P=0.11).
CONCLUSIONS


Pulsed radiofrequency of SSN and AN achieves similar therapeutic effects to the nerve block. Pulsed radiofrequency modulation is superior to nerve block in improving the PROM of shoulder abduction and external rotation.",2020,"In the PROM of shoulder abduction and external rotation, statistically, significant differences were observed between the two groups at T1 (P=0.02*, & P=0.04*) and T2 (P=0.02*, & P=0.00*).","['stroke subjects undergoing', 'patients with hemiplegic shoulder pain (HSP', 'Twenty patients with chronic stroke (over one year from onset) and HSP [visual analog scale (VAS) for pain ≥30 mm] randomly underwent']","['pulsed radiofrequency and nerve block of SSN', 'ultrasound-guided SSN and AN pulsed radiofrequency or nerve block treatment', 'HSP', 'Pulsed radiofrequency modulation', 'pulsed radiofrequency treatment of the suprascapular and axillary nerves']","['Modified Ashworth Scale (MAS) score, passive shoulder range of motion (PROM), Disability Assessment Scale (DAS) score, and EuroQol-5 dimension questionnaire (EQ-5D', 'EQ-5D responses', 'MAS score', 'DAS score', 'VAS score', 'hemiplegic shoulder pain', 'shoulder flexion and extension']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0394703', 'cui_str': 'Injection of anesthetic agent into suprascapular nerve'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0228878', 'cui_str': 'Structure of suprascapular nerve'}, {'cui': 'C0228885', 'cui_str': 'Structure of axillary nerve'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0027741', 'cui_str': 'Nerve block'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}]","[{'cui': 'C4707572', 'cui_str': 'Modified Ashworth Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0575545', 'cui_str': 'Shoulder joint - range of movement'}, {'cui': 'C3854497', 'cui_str': 'Disability assessment scale'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0231448', 'cui_str': 'Extension'}]",20.0,0.0661042,"In the PROM of shoulder abduction and external rotation, statistically, significant differences were observed between the two groups at T1 (P=0.02*, & P=0.04*) and T2 (P=0.02*, & P=0.00*).","[{'ForeName': 'Congxian', 'Initials': 'C', 'LastName': 'Yang', 'Affiliation': 'Analgesia Department of Shandong Provincial Hospital Affiliated to the Shandong First Medical University, Jinan, China.'}, {'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Imaging Department of Shandong Provincial Hospital Affiliated to the Shandong First Medical University, Jinan, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Analgesia Department of Qingdao Municipal Hospital, Qingdao, China.'}, {'ForeName': 'Yanhong', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Yidu Central Hospital, Weifang, China.'}, {'ForeName': 'Shengtao', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Analgesia Department of Shandong Provincial Hospital Affiliated to the Shandong First Medical University, Jinan, China. wshengt@126.com.'}]",Annals of palliative medicine,['10.21037/apm-20-1618']
2878,32955714,Pharmacist Interventions to Improve Specialty Medication Adherence: Study Protocol for a Randomized Controlled Trial.,"BACKGROUND


The effectiveness of specialty medications in complicated clinical conditions depends on adherence to therapy. However, specialty medications pose unique barriers to adherence.
OBJECTIVE


This study aims to determine whether pharmacist interventions improve specialty medication adherence.
METHODS


This is a single-center, pragmatic, randomized controlled trial ongoing since 10 May 2019 at an integrated health system specialty pharmacy. This study evaluates usual care compared with usual care plus patient-tailored adherence interventions. Study design and procedures were informed by focus groups with patients and specialty pharmacists. Patients at Vanderbilt Specialty Pharmacy with a proportion of days covered (PDC) < 90% in the previous 4 months are identified by a daily query of the electronic pharmacy database. A pharmacist reviews these patients' electronic health records to identify and exclude ineligible patients. Eligible patients are randomized evenly to the control or intervention arm and stratified by historical clinic nonadherence rates. Patients randomized to the intervention arm undergo a baseline assessment to clarify reasons for nonadherence and subsequently receive patient-tailored interventions based on their specific reasons. Interventions and follow-up are provided at the discretion of the intervening pharmacist. The primary outcome is PDC calculated at 8 months post-enrollment. Enrollment of 438 participants will provide 90% power to detect a 5% difference in PDC between the two arms within each nonadherence risk stratum.
DISCUSSION


This trial will evaluate the effect of patient-tailored interventions on specialty medication adherence and will inform how often and why patients are misidentified as nonadherent.
REGISTRATION


The trial was deemed a quality improvement initiative by the Vanderbilt University Institutional Review Board. It was registered in ClinicalTrials.gov (NCT03709277) on 17 October 2018.",2020,"Enrollment of 438 participants will provide 90% power to detect a 5% difference in PDC between the two arms within each nonadherence risk stratum.
","['10 May 2019 at an integrated health system specialty pharmacy', 'Patients at Vanderbilt Specialty Pharmacy with a proportion of days covered (PDC)\u2009<\u200990% in the previous 4\xa0months are identified by a daily query of the electronic pharmacy database', 'Eligible patients', '438 participants']","['pharmacist interventions', 'intervention arm undergo a baseline assessment to clarify reasons for nonadherence and subsequently receive patient-tailored interventions based on their specific reasons', 'patient-tailored interventions', 'usual care plus patient-tailored adherence interventions']","['Specialty Medication Adherence', 'PDC calculated', 'PDC']","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0037778', 'cui_str': 'Medical specialty'}, {'cui': 'C0031321', 'cui_str': 'Pharmacy service'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0439087', 'cui_str': '<90'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C3543841', 'cui_str': 'Query'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}]","[{'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]","[{'cui': 'C0037778', 'cui_str': 'Medical specialty'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}]",438.0,0.151243,"Enrollment of 438 participants will provide 90% power to detect a 5% difference in PDC between the two arms within each nonadherence risk stratum.
","[{'ForeName': 'Amanda M', 'Initials': 'AM', 'LastName': 'Kibbons', 'Affiliation': 'Vanderbilt Specialty Pharmacy, Vanderbilt University Medical Center, 726 Melrose Avenue, Nashville, TN, 37211, USA. Amanda.m.kibbons@vumc.org.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Peter', 'Affiliation': 'Vanderbilt Specialty Pharmacy, Vanderbilt University Medical Center, 726 Melrose Avenue, Nashville, TN, 37211, USA.'}, {'ForeName': 'Josh', 'Initials': 'J', 'LastName': 'DeClercq', 'Affiliation': 'The Department of Biostatistics, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Leena', 'Initials': 'L', 'LastName': 'Choi', 'Affiliation': 'The Department of Biostatistics, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Bell', 'Affiliation': 'Vanderbilt Specialty Pharmacy, Vanderbilt University Medical Center, 726 Melrose Avenue, Nashville, TN, 37211, USA.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Jolly', 'Affiliation': 'Vanderbilt Specialty Pharmacy, Vanderbilt University Medical Center, 726 Melrose Avenue, Nashville, TN, 37211, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Cherry', 'Affiliation': 'Vanderbilt Specialty Pharmacy, Vanderbilt University Medical Center, 726 Melrose Avenue, Nashville, TN, 37211, USA.'}, {'ForeName': 'Bassel', 'Initials': 'B', 'LastName': 'Alhashemi', 'Affiliation': 'Vanderbilt Specialty Pharmacy, Vanderbilt University Medical Center, 726 Melrose Avenue, Nashville, TN, 37211, USA.'}, {'ForeName': 'Nisha B', 'Initials': 'NB', 'LastName': 'Shah', 'Affiliation': 'Vanderbilt Specialty Pharmacy, Vanderbilt University Medical Center, 726 Melrose Avenue, Nashville, TN, 37211, USA.'}, {'ForeName': 'Autumn D', 'Initials': 'AD', 'LastName': 'Zuckerman', 'Affiliation': 'Vanderbilt Specialty Pharmacy, Vanderbilt University Medical Center, 726 Melrose Avenue, Nashville, TN, 37211, USA.'}]",Drugs - real world outcomes,['10.1007/s40801-020-00213-8']
2879,32950295,"Reply to Alireza Ghoreifi and Hooman Djaladat's Letter to the Editor re: Fredrik Liedberg, Petter Kollberg, Marie Allerbo, et al. Preventing Parastomal Hernia After Ileal Conduit by the Use of a Prophylactic Mesh: A Randomised Study. Eur Urol. In press. https://doi.org/10.1016/j.eururo.2020.07.033.",,2020,,[],[],['Parastomal Hernia'],[],[],"[{'cui': 'C0341539', 'cui_str': 'Parastomal hernia'}]",,0.0188002,,"[{'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Liedberg', 'Affiliation': 'Institute of Translational Medicine, Lund University, Malmö, Sweden; Department of Urology, Skåne University Hospital, Malmö, Sweden. Electronic address: fredrik.liedberg@med.lu.se.'}, {'ForeName': 'Petter', 'Initials': 'P', 'LastName': 'Kollberg', 'Affiliation': 'Institute of Translational Medicine, Lund University, Malmö, Sweden; Department of Urology, Skåne University Hospital, Malmö, Sweden; Department of Urology, Helsingborg County Hospital, Helsingborg, Sweden.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Allerbo', 'Affiliation': 'Department of Urology, Helsingborg County Hospital, Helsingborg, Sweden.'}, {'ForeName': 'Gediminas', 'Initials': 'G', 'LastName': 'Baseckas', 'Affiliation': 'Institute of Translational Medicine, Lund University, Malmö, Sweden; Department of Urology, Skåne University Hospital, Malmö, Sweden.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Brändstedt', 'Affiliation': 'Institute of Translational Medicine, Lund University, Malmö, Sweden; Department of Urology, Skåne University Hospital, Malmö, Sweden.'}, {'ForeName': 'Sigurdur', 'Initials': 'S', 'LastName': 'Gudjonsson', 'Affiliation': 'Department of Urology, Landspitali University Hospital, Reykjavik, Iceland.'}, {'ForeName': 'Oskar', 'Initials': 'O', 'LastName': 'Hagberg', 'Affiliation': 'Institute of Translational Medicine, Lund University, Malmö, Sweden; Regional Cancer Centre South, Lund, Sweden.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Håkansson', 'Affiliation': 'Department of Urology, Skåne University Hospital, Malmö, Sweden.'}, {'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Jerlström', 'Affiliation': 'Department of Urology, School of Medical Sciences, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.'}, {'ForeName': 'Annica', 'Initials': 'A', 'LastName': 'Löfgren', 'Affiliation': 'Institute of Translational Medicine, Lund University, Malmö, Sweden.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Patschan', 'Affiliation': 'Institute of Translational Medicine, Lund University, Malmö, Sweden; Department of Urology, Skåne University Hospital, Malmö, Sweden.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Sörenby', 'Affiliation': 'Institute of Translational Medicine, Lund University, Malmö, Sweden; Department of Urology, Skåne University Hospital, Malmö, Sweden.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Bläckberg', 'Affiliation': 'Department of Urology, Helsingborg County Hospital, Helsingborg, Sweden.'}]",European urology,['10.1016/j.eururo.2020.09.025']
2880,32950893,Smartphone based behavioral therapy for pain in multiple sclerosis (MS) patients: A feasibility acceptability randomized controlled study for the treatment of comorbid migraine and ms pain.,"BACKGROUND


Multiple Sclerosis (MS) and Migraine are comorbid neurologic conditions. Migraine prevalence is three times higher in the MS clinic population compared to the general population, and patients with MS and migraine are more symptomatic than patients with MS without migraine.
OBJECTIVE


We sought to conduct a pilot feasibility and acceptability study of the RELAXaHEAD app in MS-Migraine patients and to assess whether there was any change in migraine disability and MS pain-related disability.
METHODS


Randomized controlled study of patients with MS-migraine ages 18-80 years with 4+ headache days/ month who were willing to engage in smartphone based behavioral therapy. Half received the RELAXaHEAD app with progressive muscle relaxation (PMR) and the other half received the app without the PMR. Data was collected for 90 days on measures of recruitment, retention, engagement, and adherence to RELAXaHEAD. Preliminary data was also collected on migraine disability (MIDAS) and MS pain (PES).
RESULTS


Sixty-two subjects with MS-migraine were enrolled in the study (34 in PMR arm, 28 in monitored usual care arm). On average, during the 90 days, participants played the PMR on average 1.8 times per week, and for 12.9 min on days it was played. Forty-one percent (14/34) of the participants played the PMR two or more times weekly on average. Data was entered into the daily diaries, on average, 49% (44/90) of the days. There were major challenges in reaching subjects in follow-up for the efficacy data, and there was no significant change in migraine disability (MIDAS) scores or MS Pain (PES) scores from baseline to the endpoints. During the six-month follow-up, most patients felt either positively or neutral about the relaxation therapy.
CONCLUSION


There was interest in scalable accessible forms of behavioral therapy to treat migraine and MS-related pain in patients with MS and comorbid migraine. Similar to prior studies, a significant minority were willing to practice the PMR at least twice weekly. In the societal shift from telephone to more text and internet-based interactions, follow up was challenging, but those reached indicated that they appreciated the PMR and would recommend it to others. Future work should focus on engagement and efficacy.",2020,"Migraine prevalence is three times higher in the MS clinic population compared to the general population, and patients with MS and migraine are more symptomatic than patients with MS without migraine.
","['patients with MS-migraine ages 18-80 years with 4+ headache days/ month who were willing to engage in smartphone based behavioral therapy', 'Sixty-two subjects with MS-migraine were enrolled in the study (34 in PMR arm, 28 in monitored usual care arm', 'pain in multiple sclerosis (MS) patients']","['RELAXaHEAD app with progressive muscle relaxation (PMR', 'RELAXaHEAD', 'Smartphone based behavioral therapy']","['migraine disability and MS pain-related disability', 'recruitment, retention, engagement, and adherence to RELAXaHEAD', 'migraine disability (MIDAS) scores or MS Pain (PES) scores', 'migraine disability (MIDAS) and MS pain (PES', 'Migraine prevalence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0600109', 'cui_str': 'Willing'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C4517835', 'cui_str': '62'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0454043', 'cui_str': 'Jacobson technique'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0454043', 'cui_str': 'Jacobson technique'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]","[{'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}]",62.0,0.022569,"Migraine prevalence is three times higher in the MS clinic population compared to the general population, and patients with MS and migraine are more symptomatic than patients with MS without migraine.
","[{'ForeName': 'Mia T', 'Initials': 'MT', 'LastName': 'Minen', 'Affiliation': 'NYU Langone Health, Department of Neurology, 222 E 41st, Ninth floor, New York, NY, 10017. Electronic address: mia.minen@nyulangone.org.'}, {'ForeName': 'Kathryn B', 'Initials': 'KB', 'LastName': 'Schaubhut', 'Affiliation': 'Columbia University, Post-baccalaureate Premed Program, 408 Lewisohn Hall, 2970 Broadway, New York, NY 10027.'}, {'ForeName': 'Kaitlyn', 'Initials': 'K', 'LastName': 'Morio', 'Affiliation': 'Columbia University, Post-baccalaureate Premed Program, 408 Lewisohn Hall, 2970 Broadway, New York, NY 10027.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2020.102489']
2881,32956964,Efficacy of learning through play plus intervention to reduce maternal depression in women with malnourished children: A randomized controlled trial from Pakistan ✰ .,"BACKGROUND


The risk factors and adverse outcomes related to maternal depression and child malnutrition are a leading cause of morbidity and mortality in low and middle-income countries (LMIC) including Pakistan. Above 25% of women suffer from maternal depression. Up to 50% children are under-nourished which contributes to 35% of all under-5 deaths in the country.
AIM


To determine the efficacy of Learning through Play Plus Thinking Healthy Program (LTP Plus) intervention to reduce maternal depression in mothers with undernourished children.
METHODS


In this randomised controlled trial, all eligible mothers presenting to the paediatric departments were invited to participate in the study. Out of the total 256 mothers screened, 107 were included, 54 of those were randomly allocated to LTP Plus group and 53 to treatment as usual (TAU). Edinburgh Postnatal Depression Scale (EPDS) was used to screen for depression. Hamilton Depression Rating Scale (HDRS), Maternal Attachment Inventory (MAI), Social Support Scale (OSLO-3) and the Euro-QoL (EQ-5D) were used to measure the severity of depression, mother-child attachment, level of support and health related quality of life dimensions. Assessments were completed at baseline, end of intervention (3 months from baseline) and at 6 months from baseline.
RESULTS


Mothers in the LTP Plus group significantly showed improvements in depression (p<0.001), social support (p = 0.02) and quality of life (p<0.001) at the end of the intervention (LTP Plus), as compared to the TAU group, which were sustained up to 6 months after baseline.
CONCLUSION


The outcomes of LTP Plus intervention for mothers of malnourished children show promising results in reducing maternal depression and improving child outcomes. A full trial with longer-term outcomes and cost-effectiveness needs to be conducted.",2020,"RESULTS


Mothers in the LTP Plus group significantly showed improvements in depression (p<0.001), social support (p = 0.02) and quality of life (p<0.001) at the end of the intervention (LTP Plus), as compared to the TAU group, which were sustained up to 6 months after baseline.
","['Out of the total 256 mothers screened, 107 were included, 54 of those', 'mothers with undernourished children', 'eligible mothers presenting to the paediatric departments were invited to participate in the study', 'mothers of malnourished children', 'women with malnourished children']","['Learning through Play Plus Thinking Healthy Program (LTP Plus) intervention', 'learning through play plus intervention', 'LTP Plus group and 53 to treatment as usual (TAU', 'LTP Plus intervention']","['Edinburgh Postnatal Depression Scale (EPDS', 'depression (p<0.001), social support', 'maternal depression', 'severity of depression, mother-child attachment, level of support and health related quality of life dimensions', 'maternal depression and improving child outcomes', 'quality of life', 'Hamilton Depression Rating Scale (HDRS), Maternal Attachment Inventory (MAI), Social Support Scale (OSLO-3) and the Euro-QoL (EQ-5D']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0587482', 'cui_str': 'Pediatric department'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0039869', 'cui_str': 'Thinking'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0206249', 'cui_str': 'Long-Term Potentiation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0451144', 'cui_str': 'Edinburgh postnatal depression scale'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1533125', 'cui_str': 'Euro'}]",,0.148806,"RESULTS


Mothers in the LTP Plus group significantly showed improvements in depression (p<0.001), social support (p = 0.02) and quality of life (p<0.001) at the end of the intervention (LTP Plus), as compared to the TAU group, which were sustained up to 6 months after baseline.
","[{'ForeName': 'Nusrat', 'Initials': 'N', 'LastName': 'Husain', 'Affiliation': 'University of Manchester United Kingdom; Lancashire Care NHS Foundation Trust. Electronic address: Nusrat.husain@manchester.ac.uk.'}, {'ForeName': 'Tayyeba', 'Initials': 'T', 'LastName': 'Kiran', 'Affiliation': 'Pakistan Institute of Living and Learning.'}, {'ForeName': 'Sadia', 'Initials': 'S', 'LastName': 'Shah', 'Affiliation': 'Lancashire Care NHS Foundation Trust; Pakistan Institute of Living and Learning.'}, {'ForeName': 'Atif', 'Initials': 'A', 'LastName': 'Rahman', 'Affiliation': 'University of Liverpool United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Raza-Ur-Rehman', 'Affiliation': 'Dow University of Health Sciences.'}, {'ForeName': 'Qamar', 'Initials': 'Q', 'LastName': 'Saeed', 'Affiliation': 'Pakistan Institute of Living and Learning.'}, {'ForeName': 'Shehla', 'Initials': 'S', 'LastName': 'Naeem', 'Affiliation': 'Pakistan Institute of Living and Learning.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Bassett', 'Affiliation': 'Pakistan Institute of Living and Learning.'}, {'ForeName': 'Mina', 'Initials': 'M', 'LastName': 'Husain', 'Affiliation': 'Pakistan Institute of Living and Learning.'}, {'ForeName': 'Sami Ul', 'Initials': 'SU', 'LastName': 'Haq', 'Affiliation': 'Pakistan Institute of Living and Learning.'}, {'ForeName': 'Farhat', 'Initials': 'F', 'LastName': 'Jaffery', 'Affiliation': 'Karachi Medical and Dental College Pakistan.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Cohen', 'Affiliation': 'University of Toronto.'}, {'ForeName': 'Farooq', 'Initials': 'F', 'LastName': 'Naeem', 'Affiliation': 'Centre for Addiction & Mental Health, Toronto, Canada.'}, {'ForeName': 'Nasim', 'Initials': 'N', 'LastName': 'Chaudhry', 'Affiliation': 'Pakistan Institute of Living and Learning.'}]",Journal of affective disorders,['10.1016/j.jad.2020.09.001']
2882,32957009,Meal skipping and cognition along a spectrum of restrictive eating.,"OBJECTIVE


Inadequate nutrition adversely impacts brain development and cognitive functioning (Pollitt et al., 1983). Studies examining the acute impact of eating regular meals on cognition have reported inconsistent findings, necessitating the exploration of individual differences in samples contributing to equivocal results. The present study examines the impact of skipping lunch on cognitive ability in college-aged students by including eating restraint as a moderator.
METHODS


Participants were 99 college-aged students (M = 19.7 years, SD = 1.5) randomized to a blinded 'lunch' or 'lunch-omission' condition, and assessed on memory, attention, processing speed, set shifting, and eating disorder symptomology.
RESULTS


Regressing long and short-term memory on the lunch manipulation, eating restraint scores, and their interaction revealed significant interactions: those who had lunch had superior memory performance, but only for those reporting lower levels of eating restraint. Regressing set shifting speed on the manipulation, those who had lunch had slower set shifting speed than those who skipped, but only for those reporting lower levels of eating restraint.
CONCLUSIONS


Results suggest that skipping lunch may have immediate consequences on cognition, however, cognitive enhancing effects may be diminished in the presence of even low levels of eating restraint. Findings highlight the significance of purported subclinical levels of eating restraint and may inform health education strategies.",2020,"Regressing set shifting speed on the manipulation, those who had lunch had slower set shifting speed than those who skipped, but only for those reporting lower levels of eating restraint.
","['college-aged students by including eating restraint as a moderator', 'Participants were 99 college-aged students (M\xa0=\xa019.7\xa0years, SD\xa0=\xa01.5) randomized to a']","['skipping lunch', ""blinded 'lunch' or 'lunch-omission' condition, and assessed on memory, attention, processing speed, set shifting""]","['cognitive ability', 'superior memory performance', 'lunch manipulation, eating restraint scores']","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0035260', 'cui_str': 'Physical restraint'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3844012', 'cui_str': '1.5'}]","[{'cui': 'C0560435', 'cui_str': 'Does skip'}, {'cui': 'C2697949', 'cui_str': 'Lunch'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0582591', 'cui_str': 'Processing speed'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}]","[{'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C1285654', 'cui_str': 'Memory performance'}, {'cui': 'C2697949', 'cui_str': 'Lunch'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0035260', 'cui_str': 'Physical restraint'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0492838,"Regressing set shifting speed on the manipulation, those who had lunch had slower set shifting speed than those who skipped, but only for those reporting lower levels of eating restraint.
","[{'ForeName': 'Nandini', 'Initials': 'N', 'LastName': 'Datta', 'Affiliation': 'Duke University Department of Psychology and Neuroscience, Durham, NC, USA. Electronic address: nandinid@stanford.edu.'}, {'ForeName': 'Tatyana', 'Initials': 'T', 'LastName': 'Bidopia', 'Affiliation': 'Duke University Department of Psychology and Neuroscience, Durham, NC, USA.'}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Datta', 'Affiliation': 'Duke University Department of Psychology and Neuroscience, Durham, NC, USA.'}, {'ForeName': 'Gaurie', 'Initials': 'G', 'LastName': 'Mittal', 'Affiliation': 'Duke University Department of Psychology and Neuroscience, Durham, NC, USA.'}, {'ForeName': 'Franca', 'Initials': 'F', 'LastName': 'Alphin', 'Affiliation': 'Duke University Department of Family Medicine and Community Health, Durham, NC, USA.'}, {'ForeName': 'Elizabeth J', 'Initials': 'EJ', 'LastName': 'Marsh', 'Affiliation': 'Duke University Department of Psychology and Neuroscience, Durham, NC, USA.'}, {'ForeName': 'Gavan J', 'Initials': 'GJ', 'LastName': 'Fitzsimons', 'Affiliation': 'Duke University Fuqua School of Business, Durham, NC, USA.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Strauman', 'Affiliation': 'Duke University Department of Psychology and Neuroscience, Durham, NC, USA.'}, {'ForeName': 'Nancy L', 'Initials': 'NL', 'LastName': 'Zucker', 'Affiliation': 'Duke University Department of Psychology and Neuroscience, Durham, NC, USA; Duke University School of Medicine Department of Psychiatry & Behavioral Sciences, Durham, NC, USA.'}]",Eating behaviors,['10.1016/j.eatbeh.2020.101431']
2883,32957034,Landing biomechanics are not immediately altered by a single-dose patellar tendon isometric exercise protocol in male athletes with patellar tendinopathy: A single-blinded randomized cross-over trial.,"OBJECTIVES


To a) determine the acute effects of a single-dose patellar tendon isometric exercise protocol on involved limb landing biomechanics in individuals with patellar tendinopathy and asymptomatic patellar tendon pathology, and b) determine if individuals with patellar tendinopathy demonstrated changes in pain following a single-dose patellar tendon isometric exercise protocol.
DESIGN


Single-blinded randomized cross-over trial.
SETTING


Laboratory; PARTICIPANTS: 28 young male athletes with symptomatic (n = 13, age: 19.62 ± 1.61) and asymptomatic (n = 15, age: 21.13 ± 1.88) patellar tendinopathy.
MAIN OUTCOME MEASURES


Participants completed a single-dose patellar tendon isometric exercise protocol and a sham-TENS protocol, randomized and separated by 7-10 days. Pain-levels during a single-limb decline squat (SLDS) and three-dimensional biomechanics were collected during a double-limb jump-landing task before and after each intervention protocol. A mixed-model repeated measures ANOVA was conducted to compare change scores for all dependent variables.
RESULTS


There were no group × intervention interactions for change in pain (F (1, 26)  = 0.555, p = 0.463). There was one significant group × intervention interaction for vertical ground reaction force (VGRF) (F (1, 26)  = 5.33, p = 0.029). However, post-hoc testing with Bonferroni correction demonstrated no statistical significance for group (SYM: t = -1.679, p = 0.119; ASYM: t = -1.7, p = 0.107) or intervention condition (isometric: t = -2.58, p = 0.016; sham-TENS: 0.72, p = 0.460). There were no further significant group × intervention interactions (p > 0.05).
CONCLUSIONS


A single-dose patellar tendon isometric exercise protocol did not have acute effects on landing biomechanics or pain levels in male athletes with patellar tendinopathy or asymptomatic patellar tendon pathology.",2020,A single-dose patellar tendon isometric exercise protocol did not have acute effects on landing biomechanics or pain levels in male athletes with patellar tendinopathy or asymptomatic patellar tendon pathology.,"['individuals with patellar tendinopathy and asymptomatic patellar tendon pathology, and b) determine if individuals with patellar tendinopathy', '28 young male athletes with symptomatic (n\xa0=\xa013, age: 19.62\xa0±\xa01.61) and asymptomatic (n\xa0=\xa015, age: 21.13\xa0±\xa01.88) patellar tendinopathy', 'male athletes with patellar tendinopathy or asymptomatic patellar tendon pathology', 'male athletes with patellar tendinopathy']","['sham-TENS', 'single-dose patellar tendon isometric exercise protocol', 'single-limb decline squat (SLDS', 'single-dose patellar tendon isometric exercise protocol and a sham-TENS protocol', 'patellar tendon isometric exercise protocol']","['Pain-levels', 'landing biomechanics or pain levels', 'vertical ground reaction force (VGRF', 'limb landing biomechanics', 'pain']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030647', 'cui_str': 'Bone structure of patella'}, {'cui': 'C0151936', 'cui_str': 'Disorder of tendon'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0206332', 'cui_str': 'Structure of patellar ligament'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C5191374', 'cui_str': '1.88'}]","[{'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0014518', 'cui_str': 'Lyell syndrome'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0206332', 'cui_str': 'Structure of patellar ligament'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}]","[{'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0557668', 'cui_str': 'Landing'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",28.0,0.197403,A single-dose patellar tendon isometric exercise protocol did not have acute effects on landing biomechanics or pain levels in male athletes with patellar tendinopathy or asymptomatic patellar tendon pathology.,"[{'ForeName': 'Laura S', 'Initials': 'LS', 'LastName': 'Pietrosimone', 'Affiliation': 'Doctor of Physical Therapy Division, Department of Orthopedic Surgery, School of Medicine, Duke University, Durham, NC, USA. Electronic address: laura.pietrosimone@duke.edu.'}, {'ForeName': 'J Troy', 'Initials': 'JT', 'LastName': 'Blackburn', 'Affiliation': 'Department of Exercise and Sport Science, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Department of Orthopedics, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Erik A', 'Initials': 'EA', 'LastName': 'Wikstrom', 'Affiliation': 'Department of Exercise and Sport Science, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Berkoff', 'Affiliation': 'Department of Orthopedics, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Sean I', 'Initials': 'SI', 'LastName': 'Docking', 'Affiliation': 'La Trobe Sports and Exercise Research Centre, LaTrobe University, Bundooram, Australia.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Cook', 'Affiliation': 'La Trobe Sports and Exercise Research Centre, LaTrobe University, Bundooram, Australia.'}, {'ForeName': 'Darin A', 'Initials': 'DA', 'LastName': 'Padua', 'Affiliation': 'Department of Exercise and Sport Science, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Department of Orthopedics, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}]",Physical therapy in sport : official journal of the Association of Chartered Physiotherapists in Sports Medicine,['10.1016/j.ptsp.2020.09.003']
2884,32957571,Quercetin Supplementation Improves Neuromuscular Function Recovery from Muscle Damage.,"This study was aimed at investigating whether quercetin (Q) may improve the recovery of neuromuscular function and biochemical parameters in the 7 days following an eccentric exercise-induced muscle damage (EEIMD). Sixteen men (25.9 ± 3.3 y) ingested Q (1000 mg/day) or placebo (PLA) for 14 days following a double-blind crossover study design. A neuromuscular (NM) test was performed pre-post, 24 h, 48 h, 72 h, 96 h and 7 days after an intense eccentric exercise. The force-velocity relationship of the elbow flexor muscles and their maximal voluntary isometric contraction (MVIC) were recorded simultaneously to the electromyographic signals (EMG). Pain, joint angle, arm circumference, plasma creatine kinase (CK) and lactate-dehydrogenase (LDH) were also assessed. The results showed that Q supplementation significantly attenuated the strength loss compared to PLA. During the recovery, force-velocity relationship and mean fibers conduction velocity (MFCV) persisted significantly less when participants consumed PLA rather than Q, especially at the highest angular velocities ( p  < 0.02). A greater increase in biomarkers of damage was also evident in PLA with respect to Q. Q supplementation for 14 days seems able to ameliorate the recovery of eccentric exercise-induced weakness, neuromuscular function impairment and biochemical parameters increase probably due to its strong anti-inflammatory and antioxidant action.",2020,"During the recovery, force-velocity relationship and mean fibers conduction velocity (MFCV) persisted significantly less when participants consumed PLA rather than Q, especially at the highest angular velocities ( p  < 0.02).",['Sixteen men (25.9 ± 3.3 y) ingested Q (1000 mg/day) or'],"['quercetin (Q', 'Quercetin Supplementation', 'placebo (PLA']","['biomarkers of damage', 'force-velocity relationship of the elbow flexor muscles and their maximal voluntary isometric contraction (MVIC', 'recovery, force-velocity relationship and mean fibers conduction velocity (MFCV', 'strength loss', 'Pain, joint angle, arm circumference, plasma creatine kinase (CK) and lactate-dehydrogenase (LDH']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4517688', 'cui_str': '3.3'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}]","[{'cui': 'C0034392', 'cui_str': 'Quercetin'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0022205', 'cui_str': 'Muscle isometric contraction'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0234084', 'cui_str': 'Conduction rate of nerve cell and nerve fiber'}, {'cui': 'C3714552', 'cui_str': 'Debility'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0858114', 'cui_str': 'Plasma creatine'}, {'cui': 'C0031727', 'cui_str': 'Kinase'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0022917', 'cui_str': 'Lactate dehydrogenase'}]",,0.231259,"During the recovery, force-velocity relationship and mean fibers conduction velocity (MFCV) persisted significantly less when participants consumed PLA rather than Q, especially at the highest angular velocities ( p  < 0.02).","[{'ForeName': 'Ilenia', 'Initials': 'I', 'LastName': 'Bazzucchi', 'Affiliation': 'Laboratory of Exercise Physiology, Department of Movement, Human and Health Sciences, University of Rome ""Foro Italico"", Piazza Lauro De Bosis 6, 00135 Roma, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Patrizio', 'Affiliation': 'Laboratory of Exercise Physiology, Department of Movement, Human and Health Sciences, University of Rome ""Foro Italico"", Piazza Lauro De Bosis 6, 00135 Roma, Italy.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Ceci', 'Affiliation': 'Laboratory of Biochemistry of Movement, Department of Movement, Human and Health Sciences, University of Rome ""Foro Italico"", Piazza Lauro De Bosis 6, 00135 Roma, Italy.'}, {'ForeName': 'Guglielmo', 'Initials': 'G', 'LastName': 'Duranti', 'Affiliation': 'Laboratory of Biochemistry of Movement, Department of Movement, Human and Health Sciences, University of Rome ""Foro Italico"", Piazza Lauro De Bosis 6, 00135 Roma, Italy.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Sabatini', 'Affiliation': 'Laboratory of Biochemistry of Movement, Department of Movement, Human and Health Sciences, University of Rome ""Foro Italico"", Piazza Lauro De Bosis 6, 00135 Roma, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Sgrò', 'Affiliation': 'Endocrinology Unit, Department of Movement, Human and Health Sciences, University of Rome ""Foro Italico"", Piazza Lauro De Bosis 6, 00135 Roma, Italy.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Di Luigi', 'Affiliation': 'Endocrinology Unit, Department of Movement, Human and Health Sciences, University of Rome ""Foro Italico"", Piazza Lauro De Bosis 6, 00135 Roma, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Sacchetti', 'Affiliation': 'Laboratory of Exercise Physiology, Department of Movement, Human and Health Sciences, University of Rome ""Foro Italico"", Piazza Lauro De Bosis 6, 00135 Roma, Italy.'}]",Nutrients,['10.3390/nu12092850']
2885,32957604,Impact of Three-Year Intermittent Preventive Treatment Using Artemisinin-Based Combination Therapies on Malaria Morbidity in Malian Schoolchildren.,"Previous studies have shown that a single season of intermittent preventive treatment in schoolchildren (IPTsc) targeting the transmission season has reduced the rates of clinical malaria, all-cause clinic visits, asymptomatic parasitemia, and anemia. Efficacy over the course of multiple years of IPTsc has been scantly investigated.
METHODS


An open, randomized-controlled trial among schoolchildren aged 6-13 years was conducted from September 2007 to January 2010 in Kolle, Mali. Students were included in three arms: sulphadoxine-pyrimethamine+artesunate (SP+AS), amodiaquine+artesunate (AQ+AS), and control (C). All students received two full doses, given 2 months apart, and were compared with respect to the incidence of clinical malaria, all-cause clinic visits, asymptomatic parasitemia, and anemia.
RESULTS


A total of 296 students were randomized. All-cause clinic visits were in the SP+AS versus control (29 (20.1%) vs. 68 (47.2%); 20 (21.7%) vs. 41 (44.6%); and 14 (21.2%) vs. 30 (44.6%);  p  < 0.02) in 2007, 2008, and 2009, respectively. The prevalence of asymptomatic parasitemia was lower in the SP+AS compared to control (38 (7.5%) vs. 143 (28.7%); and 47 (12.7%) vs. 75 (21.2%);  p  < 0.002) in 2007 and 2008, respectively. Hemoglobin concentration was significantly higher in children receiving SP+AS (11.96, 12.06, and 12.62 g/dL) than in control children (11.60, 11.64, and 12.15 g/dL;  p  < 0.001) in 2007, 2008, and 2009, respectively. No impact on clinical malaria was observed.
CONCLUSION


IPTsc with SP+AS reduced the rates of all-cause clinic visits and anemia during a three-year implementation.",2020,"The prevalence of asymptomatic parasitemia was lower in the SP+AS compared to control (38 (7.5%) vs. 143 (28.7%); and 47 (12.7%) vs. 75 (21.2%);  p  < 0.002) in 2007 and 2008, respectively.","['schoolchildren aged 6-13 years was conducted from September 2007 to January 2010 in Kolle, Mali', 'A total of 296 students', 'Malian Schoolchildren']","['sulphadoxine-pyrimethamine+artesunate (SP+AS), amodiaquine+artesunate (AQ+AS), and control (C', 'Artemisinin-Based Combination Therapies']","['All-cause clinic visits', 'rates of all-cause clinic visits and anemia', 'Malaria Morbidity', 'Efficacy', 'prevalence of asymptomatic parasitemia', 'Hemoglobin concentration', 'clinical malaria']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0024581', 'cui_str': 'Mali'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0038679', 'cui_str': 'Sulfadoxine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0052430', 'cui_str': 'artemisinin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}]","[{'cui': 'C0008952', 'cui_str': 'Clinic Visits'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0242723', 'cui_str': 'Parasitemia'}, {'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}, {'cui': 'C4543807', 'cui_str': 'Clinical malaria'}]",296.0,0.0715299,"The prevalence of asymptomatic parasitemia was lower in the SP+AS compared to control (38 (7.5%) vs. 143 (28.7%); and 47 (12.7%) vs. 75 (21.2%);  p  < 0.002) in 2007 and 2008, respectively.","[{'ForeName': 'Hamma', 'Initials': 'H', 'LastName': 'Maiga', 'Affiliation': 'Institut National de Santé Publique, Bamako 1771, Mali.'}, {'ForeName': 'Breanna', 'Initials': 'B', 'LastName': 'Barger', 'Affiliation': 'Spokane Emergency Physicians, Spokane, WA 99201, USA.'}, {'ForeName': 'Issaka', 'Initials': 'I', 'LastName': 'Sagara', 'Affiliation': 'Malaria Research and Training Center/Department of Epidemiology of Parasitic Diseases, Faculty of Medicine and Dentistry, Faculty of Pharmacy/University of Sciences, Techniques and Technologies of Bamako, Bamako 1805, Mali.'}, {'ForeName': 'Abdoulaye', 'Initials': 'A', 'LastName': 'Guindo', 'Affiliation': 'Malaria Research and Training Center/Department of Epidemiology of Parasitic Diseases, Faculty of Medicine and Dentistry, Faculty of Pharmacy/University of Sciences, Techniques and Technologies of Bamako, Bamako 1805, Mali.'}, {'ForeName': 'Oumar B', 'Initials': 'OB', 'LastName': 'Traore', 'Affiliation': 'Malaria Research and Training Center/Department of Epidemiology of Parasitic Diseases, Faculty of Medicine and Dentistry, Faculty of Pharmacy/University of Sciences, Techniques and Technologies of Bamako, Bamako 1805, Mali.'}, {'ForeName': 'Mamadou', 'Initials': 'M', 'LastName': 'Tekete', 'Affiliation': 'Malaria Research and Training Center/Department of Epidemiology of Parasitic Diseases, Faculty of Medicine and Dentistry, Faculty of Pharmacy/University of Sciences, Techniques and Technologies of Bamako, Bamako 1805, Mali.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Dara', 'Affiliation': 'Malaria Research and Training Center/Department of Epidemiology of Parasitic Diseases, Faculty of Medicine and Dentistry, Faculty of Pharmacy/University of Sciences, Techniques and Technologies of Bamako, Bamako 1805, Mali.'}, {'ForeName': 'Zoumana I', 'Initials': 'ZI', 'LastName': 'Traore', 'Affiliation': 'Malaria Research and Training Center/Department of Epidemiology of Parasitic Diseases, Faculty of Medicine and Dentistry, Faculty of Pharmacy/University of Sciences, Techniques and Technologies of Bamako, Bamako 1805, Mali.'}, {'ForeName': 'Modibo', 'Initials': 'M', 'LastName': 'Diarra', 'Affiliation': 'Malaria Research and Training Center/Department of Epidemiology of Parasitic Diseases, Faculty of Medicine and Dentistry, Faculty of Pharmacy/University of Sciences, Techniques and Technologies of Bamako, Bamako 1805, Mali.'}, {'ForeName': 'Samba', 'Initials': 'S', 'LastName': 'Coumare', 'Affiliation': 'Malaria Research and Training Center/Department of Epidemiology of Parasitic Diseases, Faculty of Medicine and Dentistry, Faculty of Pharmacy/University of Sciences, Techniques and Technologies of Bamako, Bamako 1805, Mali.'}, {'ForeName': 'Aly', 'Initials': 'A', 'LastName': 'Kodio', 'Affiliation': 'Malaria Research and Training Center/Department of Epidemiology of Parasitic Diseases, Faculty of Medicine and Dentistry, Faculty of Pharmacy/University of Sciences, Techniques and Technologies of Bamako, Bamako 1805, Mali.'}, {'ForeName': 'Ousmane B', 'Initials': 'OB', 'LastName': 'Toure', 'Affiliation': 'Malaria Research and Training Center/Department of Epidemiology of Parasitic Diseases, Faculty of Medicine and Dentistry, Faculty of Pharmacy/University of Sciences, Techniques and Technologies of Bamako, Bamako 1805, Mali.'}, {'ForeName': 'Ogobara K', 'Initials': 'OK', 'LastName': 'Doumbo', 'Affiliation': 'Malaria Research and Training Center/Department of Epidemiology of Parasitic Diseases, Faculty of Medicine and Dentistry, Faculty of Pharmacy/University of Sciences, Techniques and Technologies of Bamako, Bamako 1805, Mali.'}, {'ForeName': 'Abdoulaye A', 'Initials': 'AA', 'LastName': 'Djimde', 'Affiliation': 'Malaria Research and Training Center/Department of Epidemiology of Parasitic Diseases, Faculty of Medicine and Dentistry, Faculty of Pharmacy/University of Sciences, Techniques and Technologies of Bamako, Bamako 1805, Mali.'}]",Tropical medicine and infectious disease,['10.3390/tropicalmed5030148']
2886,32960175,"Effectiveness of a Web-Based SUpport PRogram (SUPR) for Hearing Aid Users Aged 50+: Two-Arm, Cluster Randomized Controlled Trial.","BACKGROUND


Hearing aid (HA) use is known to improve health outcomes for people with hearing loss. Despite that, HA use is suboptimal, and communication issues and hearing-related activity limitations and participation restrictions often remain. Web-based self-management communication programs may support people with hearing loss to effectively self-manage the impact of hearing loss in their daily lives.
OBJECTIVE


The goal of the research is to examine the short- and long-term effects of a web-based self-management SUpport PRogram (SUPR) on communication strategy use (primary outcome) and a range of secondary outcomes for HA users aged 50 years and older.
METHODS


Clients of 36 HA dispensing practices were randomized to SUPR (SUPR recipients; n=180 HA users) and 34 to care as usual (controls; n=163 HA users). SUPR recipients received a practical support booklet and online materials delivered via email over the course of their 6-month HA rehabilitation trajectory. They were encouraged to appoint a communication partner and were offered optional email contact with the HA dispensing practice. The online materials included 3 instruction videos on HA handling, 5 videos on communication strategies, and 3 testimonial videos. Care as usual included a HA fitting rehabilitation trajectory only. Measurements were carried out at baseline, immediately postintervention, 6 months postintervention, and 12 months postintervention. The primary outcome measure was self-reported use of communication strategies (3 subscales of the Communication Profile for the Hearing Impaired [CPHI]). Secondary outcome measures included self-reported personal adjustment to hearing loss (CPHI); use, satisfaction and benefit of HAs and SUPR (use questionnaire; International Outcome Inventory for Hearing Aids [IOI-HA], Alternative Interventions [IOI-AI]); recommendation of HA dispensing services; self-efficacy for HA handling (Measure of Audiologic Rehabilitation Self-Efficacy for Hearing Aids [MARS-HA]); readiness to act on hearing loss (University of Rhode Island Change Assessment adapted for hearing loss [URICA-HL]); and hearing disability (Amsterdam Inventory for Auditory Disability and Handicap [AIADH]).
RESULTS


Linear mixed model analyses (intention to treat) showed no significant differences between the SUPR and control group in the course of communication strategy use (CPHI). Immediately postintervention, SUPR recipients showed significantly higher self-efficacy for advanced HA handling than the controls, which was sustained at 12 months (MARS-HA; mean difference immediately postintervention: 5.3, 95% CI 0.3 to 10.4; P=.04). Also, SUPR recipients showed significantly greater HA satisfaction than controls immediately postintervention (IOI-HA; 0.3, 95% CI 0.09 to 0.5; P=.006), which was sustained at 12 months, and significantly greater HA use than the controls immediately postintervention (IOI-HA; 0.3, 95% CI 0.02 to 0.5; P=.03), which was not sustained at 12 months.
CONCLUSIONS


This study provides ground to recommend adding SUPR to standard HA dispensing care, as long-term, modest improvements in HA outcomes were observed. Further research is needed to evaluate what adjustments to SUPR are needed to establish long-term effectiveness on outcomes in the psychosocial domain.
TRIAL REGISTRATION


ISRCTN77340339; http://www.isrctn.com/ISRCTN77340339.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


RR2-10.1136/bmjopen-2016-015012.",2020,"Immediately postintervention, SUPR recipients showed significantly higher self-efficacy for advanced HA handling than the controls, which was sustained at 12 months (MARS-HA; mean difference immediately postintervention: 5.3, 95% CI 0.3 to 10.4; P=.04).","['people with hearing loss', 'SUPR recipients', 'Hearing Aid', 'HA users aged 50 years and older', 'Clients of 36 HA dispensing practices were randomized to SUPR (SUPR recipients; n=180 HA users) and 34 to care as usual (controls; n=163 HA users', 'Users Aged 50', 'Hearing Aids']","['Web-Based SUpport PRogram (SUPR', 'instruction videos on HA handling, 5 videos on communication strategies, and 3 testimonial videos', 'web-based self-management SUpport PRogram (SUPR', 'Hearing aid (HA']","['HA satisfaction', 'self-reported use of communication strategies (3 subscales of the Communication Profile for the Hearing Impaired [CPHI', 'HA outcomes', 'self-reported personal adjustment to hearing loss (CPHI); use, satisfaction and benefit of HAs and SUPR (use questionnaire; International Outcome Inventory for Hearing Aids', 'self-efficacy']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0018768', 'cui_str': 'Hearing aid'}, {'cui': 'C0919808', 'cui_str': 'Hearing aid user'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0018768', 'cui_str': 'Hearing aid'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}]","[{'cui': 'C0018768', 'cui_str': 'Hearing aid'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C1384666', 'cui_str': 'Hearing loss'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0011053', 'cui_str': 'Deafness'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",,0.135359,"Immediately postintervention, SUPR recipients showed significantly higher self-efficacy for advanced HA handling than the controls, which was sustained at 12 months (MARS-HA; mean difference immediately postintervention: 5.3, 95% CI 0.3 to 10.4; P=.04).","[{'ForeName': 'Janine Fj', 'Initials': 'JF', 'LastName': 'Meijerink', 'Affiliation': 'Otolaryngology-Head and Neck Surgery, Ear and Hearing, Amsterdam Public Health research institute, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Marieke', 'Initials': 'M', 'LastName': 'Pronk', 'Affiliation': 'Otolaryngology-Head and Neck Surgery, Ear and Hearing, Amsterdam Public Health research institute, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Birgit I', 'Initials': 'BI', 'LastName': 'Lissenberg-Witte', 'Affiliation': 'Epidemiology and Data Science, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Jansen', 'Affiliation': 'Schoonenberg HoorSupport, Dordrecht, Netherlands.'}, {'ForeName': 'Sophia E', 'Initials': 'SE', 'LastName': 'Kramer', 'Affiliation': 'Otolaryngology-Head and Neck Surgery, Ear and Hearing, Amsterdam Public Health research institute, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}]",Journal of medical Internet research,['10.2196/17927']
2887,32960178,Understanding the Steps Toward Mobile Early Intervention for Mothers and Their Infants Exiting the Neonatal Intensive Care Unit: Descriptive Examination.,"BACKGROUND


Neonatal intensive care unit (NICU) history, combined with systemic inequities for mothers of nondominant cultures and mothers who are socioeconomically disadvantaged, places infants at an extraordinary risk for poor developmental outcomes throughout life. Although receipt of early intervention (EI) is the best single predictor of developmental outcomes among children with and at risk for early developmental delays, mothers and infants with the greatest needs are least likely to receive EI. Mobile internet-based interventions afford substantial advantages for overcoming logistical challenges that often prevent mothers who are economically disadvantaged from accessing EI. However, the bridge from the NICU to a mobile internet intervention has been virtually unexplored.
OBJECTIVE


This study aims to examine progression flow from NICU exit referral to an early mobile internet intervention to increase EI access and promote parent mediation of infant social-emotional and communication development.
METHODS


Three NICUs serving the urban poor in a Midwestern city were provided support in establishing an electronic NICU exit referral mechanism into a randomized controlled trial of a mobile internet intervention for mothers and their infants. Measurement domains to reflect the bridge to service included each crucial gateway required for navigating the path into Part C EI, including referral, screening, assessment, and intervention access. An iterative process was used and documented to facilitate each NICU in establishing an individualized accountability plan for sharing referral materials with mothers before their NICU exit. Subsequent to the referral, progression flow was documented on the basis of a real-time electronic recording of service receipt and contact records. Mother and infant risk characteristics were also assessed. Descriptive analyses were conducted to summarize and characterize each measurement domain.
RESULTS


NICU referral rates for EI were 3 to 4 times higher for open-shared versus closed-single gatekeeper referral processes. Of 86 referred dyads, 67 (78%) were screened, and of those screened, 51 (76%) were eligible for assessment. Of the 51 assessment-eligible mothers and infants, 35 dyads (69%) completed the assessment and 31 (89%) went on to complete at least one remote coaching intervention session. The dyads who accessed and engaged in intervention were racially and ethnically diverse and experiencing substantial adversity.
CONCLUSIONS


The transition from the NICU to home was fraught with missed opportunities for an EI referral. Beyond the referral, the most prominent reason for not participating in screening was that mothers could not be located after exiting the NICU. Stronger NICU referral mechanisms for EI are needed. It may be essential to initiate mobile interventions before exiting the NICU for maintaining post-NICU contact with some mothers. In contrast to a closed, single point of referral gatekeeper systems in NICUs, open, shared referral gating systems may be less stymied by individual service provider biases and disruptions.",2020,"RESULTS


NICU referral rates for EI were 3 to 4 times higher for open-shared versus closed-single gatekeeper referral processes.","['51 assessment-eligible mothers and infants, 35 dyads (69%) completed the assessment and 31 (89%) went on to complete at least one remote coaching intervention session', 'Three NICUs serving the urban poor in a Midwestern city', 'mothers who are economically disadvantaged from accessing EI', 'Of 86 referred dyads, 67 (78%) were screened, and of those screened, 51 (76%) were eligible for assessment', 'for mothers and their infants']","['Mobile internet-based interventions', 'mobile internet intervention']",[],"[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0012613', 'cui_str': 'Disadvantaged'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0242687', 'cui_str': 'Provision of early intervention service for child'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C3898714', 'cui_str': 'Internet Intervention'}]",[],51.0,0.0587987,"RESULTS


NICU referral rates for EI were 3 to 4 times higher for open-shared versus closed-single gatekeeper referral processes.","[{'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Baggett', 'Affiliation': 'Mark Chaffin Center for Healthy Development, School of Public Health, Georgia State Universtiy, Atlanta, GA, United States.'}, {'ForeName': 'Betsy', 'Initials': 'B', 'LastName': 'Davis', 'Affiliation': 'Oregon Research Institute, Eugene, OR, United States.'}, {'ForeName': 'Susan H', 'Initials': 'SH', 'LastName': 'Landry', 'Affiliation': 'University of Texas Health Sciences Center- Houston, Houston, TX, United States.'}, {'ForeName': 'Edward G', 'Initials': 'EG', 'LastName': 'Feil', 'Affiliation': 'Oregon Research Institute, Eugene, OR, United States.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Whaley', 'Affiliation': 'University of Kansas, Kansas City, KS, United States.'}, {'ForeName': 'Alana', 'Initials': 'A', 'LastName': 'Schnitz', 'Affiliation': ""Juniper Gardens Children's Project, University of Kansas, Kansas City, KS, United States.""}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Leve', 'Affiliation': 'Oregon Research Institute, Eugene, OR, United States.'}]",Journal of medical Internet research,['10.2196/18519']
2888,32960179,"Digital Cardiovascular Biomarker Responses to Transcutaneous Cervical Vagus Nerve Stimulation: State-Space Modeling, Prediction, and Simulation.","BACKGROUND


Transcutaneous cervical vagus nerve stimulation (tcVNS) is a promising alternative to implantable stimulation of the vagus nerve. With demonstrated potential in myriad applications, ranging from systemic inflammation reduction to traumatic stress attenuation, closed-loop tcVNS during periods of risk could improve treatment efficacy and reduce ineffective delivery. However, achieving this requires a deeper understanding of biomarker changes over time.
OBJECTIVE


The aim of the present study was to reveal the dynamics of relevant cardiovascular biomarkers, extracted from wearable sensing modalities, in response to tcVNS.
METHODS


Twenty-four human subjects were recruited for a randomized double-blind clinical trial, for whom electrocardiography and photoplethysmography were used to measure heart rate and photoplethysmogram amplitude responses to tcVNS, respectively. Modeling these responses in state-space, we (1) compared the biomarkers in terms of their predictability and active vs sham differentiation, (2) studied the latency between stimulation onset and measurable effects, and (3) visualized the true and model-simulated biomarker responses to tcVNS.
RESULTS


The models accurately predicted future heart rate and photoplethysmogram amplitude values with root mean square errors of approximately one-fifth the standard deviations of the data. Moreover, (1) the photoplethysmogram amplitude showed superior predictability (P=.03) and active vs sham separation compared to heart rate; (2) a consistent delay of greater than 5 seconds was found between tcVNS onset and cardiovascular effects; and (3) dynamic characteristics differentiated responses to tcVNS from the sham stimulation.
CONCLUSIONS


This work furthers the state of the art by modeling pertinent biomarker responses to tcVNS. Through subsequent analysis, we discovered three key findings with implications related to (1) wearable sensing devices for bioelectronic medicine, (2) the dominant mechanism of action for tcVNS-induced effects on cardiovascular physiology, and (3) the existence of dynamic biomarker signatures that can be leveraged when titrating therapy in closed loop.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02992899; https://clinicaltrials.gov/ct2/show/NCT02992899.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


RR2-10.1016/j.brs.2019.08.002.",2020,The models accurately predicted future heart rate and photoplethysmogram amplitude values with root mean square errors of approximately one-fifth the standard deviations of the data.,['Twenty-four human subjects'],"['electrocardiography and photoplethysmography', 'Transcutaneous cervical vagus nerve stimulation (tcVNS']","['heart rate and photoplethysmogram amplitude responses', 'superior predictability']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0080105', 'cui_str': 'Human Subjects'}]","[{'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0162599', 'cui_str': 'Photoplethysmography'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C1282910', 'cui_str': 'Upper'}]",24.0,0.288599,The models accurately predicted future heart rate and photoplethysmogram amplitude values with root mean square errors of approximately one-fifth the standard deviations of the data.,"[{'ForeName': 'Asim H', 'Initials': 'AH', 'LastName': 'Gazi', 'Affiliation': 'School of Electrical and Computer Engineering, Georgia Institute of Technology, Atlanta, GA, United States.'}, {'ForeName': 'Nil Z', 'Initials': 'NZ', 'LastName': 'Gurel', 'Affiliation': 'School of Electrical and Computer Engineering, Georgia Institute of Technology, Atlanta, GA, United States.'}, {'ForeName': 'Kristine L S', 'Initials': 'KLS', 'LastName': 'Richardson', 'Affiliation': 'School of Electrical and Computer Engineering, Georgia Institute of Technology, Atlanta, GA, United States.'}, {'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Wittbrodt', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, GA, United States.'}, {'ForeName': 'Amit J', 'Initials': 'AJ', 'LastName': 'Shah', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Atlanta, GA, United States.'}, {'ForeName': 'Viola', 'Initials': 'V', 'LastName': 'Vaccarino', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Atlanta, GA, United States.'}, {'ForeName': 'J Douglas', 'Initials': 'JD', 'LastName': 'Bremner', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, GA, United States.'}, {'ForeName': 'Omer T', 'Initials': 'OT', 'LastName': 'Inan', 'Affiliation': 'School of Electrical and Computer Engineering, Georgia Institute of Technology, Atlanta, GA, United States.'}]",JMIR mHealth and uHealth,['10.2196/20488']
2889,32977015,Effect of Retrograde Autologous Blood Priming of Cardiopulmonary Bypass on Hemodynamic Parameters and Pulmonary Mechanics in Pediatric Cardiac Surgery: A Randomized Clinical Study.,"The present study aimed to assess the impact of retrograde autologous priming (RAP) on hemodynamics and pulmonary mechanics in children subjected to cardiothoracic surgery. This prospective randomized study analyzed the clinical records of 124 children with risk adjustment in congenital heart surgery-1 left to right lesions subjected to cardiac surgery. They comprised 64 patients in RAP group and 60 patients in the conventional priming group. The preoperative, intraoperative and postoperative data of the studied patients were reported. The outcome measures included hematocrit (Hct) value, blood gases, lung mechanics parameters, transfusion needs, ICU stay, postoperative complications and mortality. Preoperatively, there were no significant differences between the studied groups regarding the demographic data, underlying lesions, laboratory data, blood gases and pulmonary mechanics parameters. Intraoperatively, RAP group patients had significantly lower amount of blood loss, less frequent need to packed red blood cells (RBC)s transfusion and better Hct values when compared with the control group. Postoperatively, RAP group patients had significantly higher Hct% at ICU arrival, significantly better pulmonary mechanics parameters and significantly shorter duration on mechanical ventilation. RAP in children older than 12 months subjected to cardiac surgery for risk adjustment in congenital heart surgery-1 left to right lesions is associated with less transfusion needs and better pulmonary mechanics.",2020,"Postoperatively, RAP group patients had significantly higher Hct % at ICU arrival, significantly better pulmonary mechanics parameters and significantly shorter duration on mechanical ventilation.","['children subjected to cardiothoracic surgery', '64 patients in RAP group and 60 patients in the conventional priming group', 'Pediatric Cardiac Surgery', '124 children with Rachs-1 left to right lesions subjected to cardiac surgery', 'children older than 12 months subjected to cardiac surgery for Rachs-1 left to right lesions']","['Retrograde Autologous Blood Priming of Cardiopulmonary Bypass', 'retrograde autologous priming (RAP', 'Retrograde autologous priming']","['packed RBCs transfusion and better hematocrit values', 'demographic data, underlying lesions, laboratory data, blood gases and pulmonary mechanics parameters', 'mechanical ventilation', 'hematocrit value, blood gases, lung mechanics parameters, transfusion needs, ICU stay, postoperative complications and mortality', 'pulmonary mechanics parameters', 'Hemodynamic Parameters and Pulmonary Mechanics', 'blood loss', 'hemodynamics and pulmonary mechanics']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1274037', 'cui_str': 'Cardiothoracic surgery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439784', 'cui_str': 'Retrograde direction'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0331021', 'cui_str': 'Ligustrum vulgare'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0439757', 'cui_str': 'Left to right'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0439784', 'cui_str': 'Retrograde direction'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}]","[{'cui': 'C0184967', 'cui_str': 'Insertion of pack'}, {'cui': 'C0014792', 'cui_str': 'erythrocytes'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0005800', 'cui_str': 'Blood gas analysis'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0376706', 'cui_str': 'Mechanics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",124.0,0.031047,"Postoperatively, RAP group patients had significantly higher Hct % at ICU arrival, significantly better pulmonary mechanics parameters and significantly shorter duration on mechanical ventilation.","[{'ForeName': 'Hamdy', 'Initials': 'H', 'LastName': 'Singab', 'Affiliation': 'Cardiothoracic Surgery Department, Ain Shams University Faculty of Medicine, Ain Shams University Hospitals, Cairo, Egypt. Electronic address: hamdi_singab@hotmail.com.'}, {'ForeName': 'Mohamed A', 'Initials': 'MA', 'LastName': 'Gamal', 'Affiliation': 'Cardiothoracic Surgery Department, Ain Shams University Faculty of Medicine, Ain Shams University Hospitals, Cairo, Egypt.'}, {'ForeName': 'Reda', 'Initials': 'R', 'LastName': 'Refaey', 'Affiliation': 'Cardiothoracic Surgery Department, Ain Shams University Faculty of Medicine, Ain Shams University Hospitals, Cairo, Egypt.'}, {'ForeName': 'Waleed', 'Initials': 'W', 'LastName': 'Al-Taher', 'Affiliation': 'Anesthesia and Intensive Care Department, Ain Shams University Faculty of Medicine, Ain Shams University Hospitals, Cairo, Egypt.'}]",Seminars in thoracic and cardiovascular surgery,['10.1053/j.semtcvs.2020.09.006']
2890,32977025,Seizure threshold manipulation in electroconvulsive therapy via repetitive transcranial magnetic stimulation. A novel way of augmentation?,"INTRODUCTION


A high seizure threshold (ST) is an impeding factor in certain patients, potentially preventing a successful electroconvulsive therapy (ECT) treatment. Several pharmacological and non-pharmacological methods have been put forward to augment ECT in such patients, however, to this date, only a handful of case reports existed about the potential role of repetitive transcranial magnetic stimulation (rTMS), as an augmentation method.
OBJECTIVES


and Methods: In this randomized, double-blinded, sham controlled study, we set out to test the hypothesis of whether the application of high frequency transcranial magnetic stimulation (HF rTMS) lowers the seizure threshold for electroconvulsive therapy and whether it has an effect on other aspects of ECT treatment, such as seizure duration (SD), efficacy and safety.
RESULTS


46 patients treated for a major depressive episode, indicated for ECT, were recruited to this study. A significantly lower seizure threshold was observed in the experimental group during ECT titration, on average a decrease by 34.55%, from 34.23 mC to 22.4 mC, p < 0.001 (Wilcox test). We had not observed a significant effect of TMS stimulation before ECT on seizure duration or clinical outcome. Another potentially important observation of this study is that 4 patients in the experimental group developed transient symptoms of hypomania/mania, all of which were stabilized after the combined stimulation protocol was halted spontaneously within a week, without the need to administer mood stabilizers.
CONCLUSION


It is likely that HF rTMS stimulation prior to ECT is a novel and simple way of reducing the ST, which is useful in certain groups of patients undergoing this important treatment modality.",2020,"A significantly lower seizure threshold was observed in the experimental group during ECT titration, on average a decrease by 34.55%, from 34.23mC to 22.4mC, p < 0.001 (Wilcox test).","['46 patients treated for a major depressive episode, indicated for ECT']","['electroconvulsive therapy via repetitive transcranial magnetic stimulation', 'repetitive transcranial magnetic stimulation (rTMS', 'high frequency transcranial magnetic stimulation (HF rTMS']","['seizure duration (SD), efficacy and safety', 'seizure threshold', 'transient symptoms of hypomania/mania', 'TMS stimulation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C0024517', 'cui_str': 'Major depression, single episode'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}]","[{'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}]","[{'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0241934', 'cui_str': 'Hypomania'}, {'cui': 'C0338831', 'cui_str': 'Mania'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]",46.0,0.0778151,"A significantly lower seizure threshold was observed in the experimental group during ECT titration, on average a decrease by 34.55%, from 34.23mC to 22.4mC, p < 0.001 (Wilcox test).","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Buday', 'Affiliation': 'Department of Psychiatry, Charles University, General University Hospital in Prague, Czech Republic. Electronic address: jozef.buday@vfn.cz.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Albrecht', 'Affiliation': 'Department of Psychiatry, Charles University, General University Hospital in Prague, Czech Republic.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Podgorná', 'Affiliation': 'Department of Psychiatry, Charles University, General University Hospital in Prague, Czech Republic.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Mareš', 'Affiliation': 'Department of Psychiatry, Charles University, General University Hospital in Prague, Czech Republic.'}, {'ForeName': 'T H', 'Initials': 'TH', 'LastName': 'Le', 'Affiliation': 'Department of Psychiatry, Charles University, General University Hospital in Prague, Czech Republic.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Čapek', 'Affiliation': 'Department of Psychiatry, Charles University, General University Hospital in Prague, Czech Republic.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Mahrík', 'Affiliation': 'Institute of Clinical and Experimental Medicine, Czech Republic.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Pol', 'Affiliation': 'Institute of Clinical and Experimental Medicine, Czech Republic.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Raboch', 'Affiliation': 'Department of Psychiatry, Charles University, General University Hospital in Prague, Czech Republic.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Anders', 'Affiliation': 'Department of Psychiatry, Charles University, General University Hospital in Prague, Czech Republic.'}]",Brain stimulation,['10.1016/j.brs.2020.09.008']
2891,32977137,Therapeutic versus prophylactic anticoagulation for severe COVID-19: A randomized phase II clinical trial (HESACOVID).,"INTRODUCTION


Coronavirus disease 2019 (COVID-19) causes a hypercoagulable state. Several autopsy studies have found microthrombi in pulmonary circulation.
METHODS


In this randomized, open-label, phase II study, we randomized COVID-19 patients requiring mechanical ventilation to receive either therapeutic enoxaparin or the standard anticoagulant thromboprophylaxis. We evaluated the gas exchange over time through the ratio of partial pressure of arterial oxygen (PaO2) to the fraction of inspired oxygen (FiO2) at baseline, 7, and 14 days after randomization, the time until successful liberation from mechanical ventilation, and the ventilator-free days.
RESULTS


Ten patients were assigned to the therapeutic enoxaparin and ten patients to prophylactic anticoagulation. There was a statistically significant increase in the PaO2/FiO2 ratio over time in the therapeutic group (163 [95% confidence interval - CI 133-193] at baseline, 209 [95% CI 171-247] after 7 days, and 261 [95% CI 230-293] after 14 days), p = 0.0004. In contrast, we did not observe this improvement over time in the prophylactic group (184 [95% CI 146-222] at baseline, 168 [95% CI 142-195] after 7 days, and 195 [95% CI 128-262] after 14 days), p = 0.487. Patients of the therapeutic group had a higher ratio of successful liberation from mechanical ventilation (hazard ratio: 4.0 [95% CI 1.035-15.053]), p = 0.031 and more ventilator-free days (15 days [interquartile range IQR 6-16] versus 0 days [IQR 0-11]), p = 0.028 when compared to the prophylactic group.
CONCLUSION


Therapeutic enoxaparin improves gas exchange and decreases the need for mechanical ventilation in severe COVID-19.
TRIAL REGISTRATION


REBEC RBR-949z6v.",2020,"Patients of the therapeutic group had a higher ratio of successful liberation from mechanical ventilation (hazard ratio: 4.0 [95% CI 1.035-15.053]), p = ","['COVID-19 patients requiring mechanical ventilation to receive either', 'severe COVID-19']","['Therapeutic versus prophylactic anticoagulation', 'enoxaparin', 'prophylactic anticoagulation', 'therapeutic enoxaparin', 'therapeutic enoxaparin or the standard anticoagulant thromboprophylaxis']","['PaO2/FiO2 ratio', 'higher ratio of successful liberation from mechanical ventilation', 'gas exchange over time through the ratio of partial pressure of arterial oxygen (PaO2) to the fraction of inspired oxygen (FiO2']","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0206460', 'cui_str': 'Enoxaparin'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030604', 'cui_str': 'Partial pressure'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0428167', 'cui_str': 'Fraction of inspired oxygen'}]",10.0,0.230806,"Patients of the therapeutic group had a higher ratio of successful liberation from mechanical ventilation (hazard ratio: 4.0 [95% CI 1.035-15.053]), p = ","[{'ForeName': 'Anna Cristina Bertoldi', 'Initials': 'ACB', 'LastName': 'Lemos', 'Affiliation': 'Division of Emergency Medicine, Department of Internal Medicine, Ribeirão Preto School of Medicine, São Paulo University, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Douglas Alexandre', 'Initials': 'DA', 'LastName': 'do Espírito Santo', 'Affiliation': 'Division of Emergency Medicine, Department of Internal Medicine, Ribeirão Preto School of Medicine, São Paulo University, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Maísa Cabetti', 'Initials': 'MC', 'LastName': 'Salvetti', 'Affiliation': 'Hospital Estadual de Américo Brasiliense, Ribeirão Preto School of Medicine, São Paulo University, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Renato Noffs', 'Initials': 'RN', 'LastName': 'Gilio', 'Affiliation': 'Hospital Estadual de Américo Brasiliense, Ribeirão Preto School of Medicine, São Paulo University, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Lucas Barbosa', 'Initials': 'LB', 'LastName': 'Agra', 'Affiliation': 'Division of Emergency Medicine, Department of Internal Medicine, Ribeirão Preto School of Medicine, São Paulo University, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Pazin-Filho', 'Affiliation': 'Division of Emergency Medicine, Department of Internal Medicine, Ribeirão Preto School of Medicine, São Paulo University, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Carlos Henrique', 'Initials': 'CH', 'LastName': 'Miranda', 'Affiliation': 'Division of Emergency Medicine, Department of Internal Medicine, Ribeirão Preto School of Medicine, São Paulo University, Ribeirão Preto, SP, Brazil. Electronic address: chmiranda@fmrp.usp.br.'}]",Thrombosis research,['10.1016/j.thromres.2020.09.026']
2892,32977202,The differential impact of viewing fitspiration and thinspiration images on men's body image concerns: An experimental ecological momentary assessment study.,"To date, little is known about the impact of fitspiration and thinspiration exposure on men, as previous studies on these social media trends were primarily conducted on women. Male participants (n = 223) completed baseline measures of trait body image, then used a smartphone application to complete up to six state-based assessments daily for seven days. In each assessment, participants were randomly assigned to one of three image conditions (fitspiration, thinspiration, or neutral). Before and after viewing each image, they reported state body fat dissatisfaction, muscularity dissatisfaction, negative mood, and urge to engage in behaviours to reduce body fat and increase muscularity. Multi-level analyses revealed that compared to viewing neutral images, viewing fitspiration images increased men's body dissatisfaction, whereas viewing thinspiration images decreased body dissatisfaction. Viewing either fit- or thinspiration images also led to lower mood and greater urges to increase muscularity, whereas only fitspiration images increased urges to reduce body fat. Men with greater baseline muscularity dissatisfaction and higher appearance comparison were most vulnerable to muscularity dissatisfaction after viewing fitspiration images. Findings suggest the importance of limiting exposure to fitspiration imagery and implementing social media literacy programmes for men and well as women.",2020,"Viewing either fit- or thinspiration images also led to lower mood and greater urges to increase muscularity, whereas only fitspiration images increased urges to reduce body fat.","['men and well as women', 'Male participants (n = 223', ""men's body image concerns""]",['viewing fitspiration and thinspiration images'],[],"[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0005891', 'cui_str': 'Body image'}]","[{'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}]",[],223.0,0.019817,"Viewing either fit- or thinspiration images also led to lower mood and greater urges to increase muscularity, whereas only fitspiration images increased urges to reduce body fat.","[{'ForeName': 'Zhi Wei', 'Initials': 'ZW', 'LastName': 'Yee', 'Affiliation': 'Melbourne School of Psychological Sciences, The University of Melbourne, Redmond Barry Building, Melbourne, VIC, 3010, Australia. Electronic address: zhiwei@student.unimelb.edu.au.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Griffiths', 'Affiliation': 'Melbourne School of Psychological Sciences, The University of Melbourne, Redmond Barry Building, Melbourne, VIC, 3010, Australia. Electronic address: scott.griffiths@unimelb.edu.au.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Fuller-Tyszkiewicz', 'Affiliation': 'Centre for Social and Early Emotional Development, School of Psychology, Deakin University, Burwood, VIC, 3125, Australia; School of Psychology, Deakin University, Burwood, VIC, 3125, Australia. Electronic address: matthew.fuller.tyszkiewicz@deakin.edu.au.'}, {'ForeName': 'Khandis', 'Initials': 'K', 'LastName': 'Blake', 'Affiliation': 'Melbourne School of Psychological Sciences, The University of Melbourne, Redmond Barry Building, Melbourne, VIC, 3010, Australia. Electronic address: khandis.blake@unimelb.edu.au.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Richardson', 'Affiliation': 'School of Psychology, Deakin University, Burwood, VIC, 3125, Australia. Electronic address: Ben.Richardson@nousgroup.com.au.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Krug', 'Affiliation': 'Melbourne School of Psychological Sciences, The University of Melbourne, Redmond Barry Building, Melbourne, VIC, 3010, Australia. Electronic address: Isabel.krug@unimelb.edu.au.'}]",Body image,['10.1016/j.bodyim.2020.08.008']
2893,32977212,Behavioral and electrophysiological effects of network-based frontoparietal tDCS in patients with severe brain injury: A randomized controlled trial.,"BACKGROUND


Transcranial direct current stimulation (tDCS) may promote the recovery of severely brain-injured patients with disorders of consciousness (DOC). Prior tDCS studies targeted single brain regions rather than brain networks critical for consciousness recovery.
OBJECTIVE


Investigate the behavioral and electrophysiological effects of multifocal tDCS applied over the frontoparietal external awareness network in patients with chronic acquired DOC.
METHODS


Forty-six patients were included in this randomized double-blind sham-controlled crossover trial (median [interquartile range]: 46 [35 - 59] years old; 12 [5 - 47] months post injury; 17 unresponsive wakefulness syndrome, 23 minimally conscious state (MCS) and 6 emerged from the MCS). Multifocal tDCS was applied for 20 min using 4 anodes and 4 cathodes with 1 mA per electrode. Coma Recovery Scale-Revised (CRS-R) assessment and 10 min of resting state electroencephalogram (EEG) recordings were acquired before and after the active and sham sessions.
RESULTS


At the group level, there was no tDCS behavioral treatment effect. However, following active tDCS, the EEG complexity significantly increased in low frequency bands (1-8 Hz). CRS-R total score improvement was associated with decreased baseline complexity in those bands. At the individual level, after active tDCS, new behaviors consistent with conscious awareness emerged in 5 patients. Conversely, 3 patients lost behaviors consistent with conscious awareness.
CONCLUSION


The behavioral effect of multifocal frontoparietal tDCS varies across patients with DOC. Electrophysiological changes were observed in low frequency bands but not translated into behavioral changes at the group level.",2020,"At the group level, there was no tDCS behavioral treatment effect.","['severely brain-injured patients with disorders of consciousness (DOC', 'patients with severe brain injury', 'Forty-six patients', 'patients with chronic acquired DOC', 'patients with DOC']","['multifocal tDCS', 'network-based frontoparietal tDCS', 'Transcranial direct current stimulation (tDCS', 'minimally conscious state (MCS) and 6 emerged from the MCS']","['EEG complexity', 'CRS-R total score improvement', 'Electrophysiological changes', 'Coma Recovery Scale-Revised (CRS-R) assessment and 10\xa0min of resting state electroencephalogram (EEG) recordings']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009792', 'cui_str': 'Consciousness Disorders'}, {'cui': 'C0270611', 'cui_str': 'Brain injury'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0439661', 'cui_str': 'Acquired'}]","[{'cui': 'C0205292', 'cui_str': 'Multifocal'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0751699', 'cui_str': 'Minimally conscious state'}, {'cui': 'C0036221', 'cui_str': 'Mast cell sarcoma'}]","[{'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0009421', 'cui_str': 'Coma'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0010278', 'cui_str': 'Craniosynostosis syndrome'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}]",46.0,0.240193,"At the group level, there was no tDCS behavioral treatment effect.","[{'ForeName': 'Géraldine', 'Initials': 'G', 'LastName': 'Martens', 'Affiliation': ""Coma Science Group, GIGA Consciousness, University of Liège, Liège, Belgium; Centre du Cerveau2 - Centre intégré pluridisciplinaire de l'étude du cerveau, de la cognition et de la conscience, University Hospital of Liège, Liège, Belgium. Electronic address: geraldine.martens@uliege.be.""}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Kroupi', 'Affiliation': 'Starlab Barcelona SL, Barcelona, Spain.'}, {'ForeName': 'Yelena', 'Initials': 'Y', 'LastName': 'Bodien', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, MA, USA; Laboratory for Neuroimaging in Coma and Consciousness, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Frasso', 'Affiliation': 'Coma Science Group, GIGA Consciousness, University of Liège, Liège, Belgium.'}, {'ForeName': 'Jitka', 'Initials': 'J', 'LastName': 'Annen', 'Affiliation': ""Coma Science Group, GIGA Consciousness, University of Liège, Liège, Belgium; Centre du Cerveau2 - Centre intégré pluridisciplinaire de l'étude du cerveau, de la cognition et de la conscience, University Hospital of Liège, Liège, Belgium.""}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Cassol', 'Affiliation': ""Coma Science Group, GIGA Consciousness, University of Liège, Liège, Belgium; Centre du Cerveau2 - Centre intégré pluridisciplinaire de l'étude du cerveau, de la cognition et de la conscience, University Hospital of Liège, Liège, Belgium.""}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Barra', 'Affiliation': ""Coma Science Group, GIGA Consciousness, University of Liège, Liège, Belgium; Centre du Cerveau2 - Centre intégré pluridisciplinaire de l'étude du cerveau, de la cognition et de la conscience, University Hospital of Liège, Liège, Belgium.""}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Martial', 'Affiliation': ""Coma Science Group, GIGA Consciousness, University of Liège, Liège, Belgium; Centre du Cerveau2 - Centre intégré pluridisciplinaire de l'étude du cerveau, de la cognition et de la conscience, University Hospital of Liège, Liège, Belgium.""}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Gosseries', 'Affiliation': ""Coma Science Group, GIGA Consciousness, University of Liège, Liège, Belgium; Centre du Cerveau2 - Centre intégré pluridisciplinaire de l'étude du cerveau, de la cognition et de la conscience, University Hospital of Liège, Liège, Belgium.""}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Lejeune', 'Affiliation': 'Coma Science Group, GIGA Consciousness, University of Liège, Liège, Belgium; Centre Hospitalier Neurologique William Lennox, Saint-Luc University Clinics, Université Catholique de Louvain, Belgium.'}, {'ForeName': 'Aureli', 'Initials': 'A', 'LastName': 'Soria-Frisch', 'Affiliation': 'Starlab Barcelona SL, Barcelona, Spain.'}, {'ForeName': 'Giulio', 'Initials': 'G', 'LastName': 'Ruffini', 'Affiliation': 'Starlab Barcelona SL, Barcelona, Spain.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Laureys', 'Affiliation': ""Coma Science Group, GIGA Consciousness, University of Liège, Liège, Belgium; Centre du Cerveau2 - Centre intégré pluridisciplinaire de l'étude du cerveau, de la cognition et de la conscience, University Hospital of Liège, Liège, Belgium.""}, {'ForeName': 'Aurore', 'Initials': 'A', 'LastName': 'Thibaut', 'Affiliation': ""Coma Science Group, GIGA Consciousness, University of Liège, Liège, Belgium; Centre du Cerveau2 - Centre intégré pluridisciplinaire de l'étude du cerveau, de la cognition et de la conscience, University Hospital of Liège, Liège, Belgium; Neuromodulation Center, Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, USA.""}]",NeuroImage. Clinical,['10.1016/j.nicl.2020.102426']
2894,32977220,Phase I/II trial of sequential treatment of nab-paclitaxel in combination with gemcitabine followed by modified FOLFOX chemotherapy in patients with untreated metastatic exocrine pancreatic cancer: Phase I results.,"BACKGROUND


Although occasioned through different mechanisms, the potential neurotoxicity and also haematological toxicity of nab-paclitaxel and oxaliplatin-based chemotherapy regimen were studied in this trial, which aimed to determine the maximum-tolerated dose (MTD) and to evaluate safety and efficacy of the combination in a sequential regimen of nab-paclitaxel, gemcitabine (GEM) and modified FOLFOX (mFOLFOX) in untreated patients with metastatic pancreatic ductal adenocarcinoma (PDAC).
MATERIALS AND METHODS


Treatment consisted of nab-paclitaxel (125/100 mg/m 2 ) plus GEM (1000/800 mg/m 2 ) on days 1, 8 and 15, followed by mFOLFOX (oxaliplatin [85/75/65 mg/m 2 ], 5-FU bolus [400/300/200 mg/m 2 ], 5-FU infusion [2400/2000/1600 mg/m 2 ]) on day 28, of a 42-day cycle. Patients were enrolled at the highest dose level with a subsequent 3 + 3 dose de-escalation plan.
RESULTS


Eleven patients (median age = 61, 64% with performance status [PS] = 1) were eligible. All patients received the highest dose level. No de-escalation was needed. A dose-limiting toxicity was reported, an upper gastrointestinal haemorrhage. The MTD was nab-paclitaxel 125 mg/m 2 , GEM 1000 mg/m 2 , oxaliplatin 85 mg/m 2 , 5-FU bolus 400 mg/m 2  and 5-FU infusion 2400 mg/m 2 . Common all-grade toxicities were neutropenia (73%), anaemia (55%), thrombocytopenia (55%) and asthenia (55%). Other relevant toxicities were paraesthesia (46%), nausea (36%), dysesthesia (27%) and pyrexia (27%). Objective response rate was 50% and disease control rate was 80%.
CONCLUSIONS


The regimen of nab-paclitaxel plus GEM followed by mFOLFOX showed favourable safety and tolerability profiles with significant anti-tumor activity. More data are being achieved in a randomised phase II trial, to confirm efficacy rates and dismiss long-term neurotoxicity concerns regarding the sequencing of nab-paclitaxel and oxaliplatin.",2020,No de-escalation was needed.,"['untreated patients with metastatic pancreatic ductal adenocarcinoma (PDAC', 'patients with untreated metastatic exocrine pancreatic cancer', 'Eleven patients (median age\xa0=\xa061, 64% with performance status [PS]\xa0=\xa01) were eligible']","['gemcitabine followed by modified FOLFOX chemotherapy', '5-FU infusion 2400', 'nab-paclitaxel', 'paclitaxel', 'paclitaxel and oxaliplatin-based chemotherapy', 'oxaliplatin', 'oxaliplatin 85\xa0mg/m 2 , 5-FU bolus 400', 'nab-paclitaxel plus GEM', 'mFOLFOX (oxaliplatin [85/75/65\xa0mg/m 2 ], 5-FU bolus [400/300/200\xa0mg/m 2 ], 5-FU infusion', 'nab-paclitaxel, gemcitabine (GEM) and modified FOLFOX (mFOLFOX', 'nab-paclitaxel (125/100\xa0mg/m 2 ) plus GEM']","['disease control rate', 'favourable safety and tolerability profiles', 'thrombocytopenia', 'asthenia', 'nausea', 'Objective response rate', 'neutropenia', 'anaemia', 'pyrexia']","[{'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C1335302', 'cui_str': 'Ductal adenocarcinoma of pancreas'}, {'cui': 'C0346648', 'cui_str': 'Malignant tumor of exocrine pancreas'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0449438', 'cui_str': 'Status'}]","[{'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C4517656', 'cui_str': '2400'}, {'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0004093', 'cui_str': 'Asthenia'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0015967', 'cui_str': 'Fever'}]",1.0,0.0271254,No de-escalation was needed.,"[{'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Carrato', 'Affiliation': 'Ramon y Cajal University Hospital, Madrid. Spain; University of Alcalá. Alcalá de Henares, Madrid. Spain; Ramon y Cajal Institute for Health Research (IRYCIS), Laboratory of Molecular Biology, Madrid. Spain; CIBERONC, Madrid. Spain. Electronic address: acarrato@telefonica.net.'}, {'ForeName': 'José María', 'Initials': 'JM', 'LastName': 'Vieitez', 'Affiliation': 'University Central Hospital of Asturias, Oviedo. Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Benavides', 'Affiliation': 'University Regional Hospital and Virgen de la Victoria, Málaga. Spain; IBIMA, Málaga. Spain.'}, {'ForeName': 'Mercedes', 'Initials': 'M', 'LastName': 'Rodriguez-Garrote', 'Affiliation': 'Ramon y Cajal University Hospital, Madrid. Spain; Ramon y Cajal Institute for Health Research (IRYCIS), Laboratory of Molecular Biology, Madrid. Spain; CIBERONC, Madrid. Spain.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Castillo', 'Affiliation': 'University Central Hospital of Asturias, Oviedo. Spain.'}, {'ForeName': 'Gema Durán', 'Initials': 'GD', 'LastName': 'Ogalla', 'Affiliation': 'University Regional Hospital and Virgen de la Victoria, Málaga. Spain; IBIMA, Málaga. Spain.'}, {'ForeName': 'Laura García', 'Initials': 'LG', 'LastName': 'Bermejo', 'Affiliation': 'Ramon y Cajal University Hospital, Madrid. Spain; University of Alcalá. Alcalá de Henares, Madrid. Spain.'}, {'ForeName': 'Inmaculada', 'Initials': 'I', 'LastName': 'Ruiz de Mena', 'Affiliation': 'Spanish Cooperative Group for the Treatment of Digestive Tumors (TTD).'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Guillén-Ponce', 'Affiliation': 'Ramon y Cajal University Hospital, Madrid. Spain; Ramon y Cajal Institute for Health Research (IRYCIS), Laboratory of Molecular Biology, Madrid. Spain.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Aranda', 'Affiliation': 'CIBERONC, Madrid. Spain; IMIBIC, Córdoba. Spain; Reina Sofia University Hospital, Córdoba. Spain; University of Córdoba, Córdoba. Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.07.035']
2895,32978020,"Reprint of ""The detection of knee joint sounds at defined loads by means of vibroarthrography"".","BACKGROUND


Crepitus of the knee may mirror structural and functional changes in the joint during motion. Although the magnitude of these sounds increases with greater cartilage damage, it is unclear whether knee joint sounds also reflect joint loading.
METHODS


Twelve healthy volunteers (mean 26 (SD 3.6) years, 7 females) participated in the randomized-balanced crossover study. Knee joint sounds were recorded (linear sampling, 5512 Hz) by means of two microphones, one placed on the medial tibial plateau and one on the patella. Two activities of daily living (standing up from/sitting down on a bench; descending stairs) and three open kinetic chain knee extension-flexion cycles (passive movement, 10% and 40% loading of the individual one repetition maximum) were performed. Each participant carried out three sets of five repetitions and three sets of 15 steps downwards (stairs), respectively. For data analysis, the mean sound amplitude and the median power frequency for each loading condition were determined. Friedman test and Bonferroni-Holm adjusted post-hoc test were performed to detect differences between conditions.
FINDINGS


We obtained significant differences between joint sound amplitudes for all movements, both measured at the medial tibial plateau (Chi 2  = 20.7, p < 0.001) and at the patella (Chi 2  = 27.6, p < 0.001). We showed a significant difference in the median power frequency of the patella between all movements (Chi 2  = 17.8, p < 0.5).
INTERPRETATION


Overall, the larger the supposed knee joint loading was, the louder was the recorded knee crepitus. Consequently, vibroarthrographically assessed knee joint sounds can differ across knee joint loading conditions.",2020,"We obtained significant differences between joint sound amplitudes for all movements, both measured at the medial tibial plateau","['mean 26 (SD 3.6) years, 7 females', 'Twelve healthy volunteers']","['daily living (standing up from/sitting down on a bench; descending stairs) and three open kinetic chain knee extension-flexion cycles (passive movement, 10% and 40% loading of the individual one repetition maximum']","['medial tibial plateau', 'median power frequency of the patella', 'Knee joint sounds']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517694', 'cui_str': '3.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0444796', 'cui_str': 'Standing up'}, {'cui': 'C0560831', 'cui_str': 'Does sit down'}, {'cui': 'C0205386', 'cui_str': 'Descending'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0444509', 'cui_str': 'Flexion/extension'}, {'cui': 'C0079991', 'cui_str': 'Passive movement'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}]","[{'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0584640', 'cui_str': 'Tibial plateau structure'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0030647', 'cui_str': 'Bone structure of patella'}, {'cui': 'C0022745', 'cui_str': 'Knee joint structure'}, {'cui': 'C0037709', 'cui_str': 'Sonic Radiation'}]",12.0,0.0360668,"We obtained significant differences between joint sound amplitudes for all movements, both measured at the medial tibial plateau","[{'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Kalo', 'Affiliation': 'Department of Sports Medicine, Goethe University Frankfurt am Main, Germany. Electronic address: kalo@rz.uni-frankfurt.de.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Niederer', 'Affiliation': 'Department of Sports Medicine, Goethe University Frankfurt am Main, Germany.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Sus', 'Affiliation': 'Faculty of Health Sciences, University of Applied Sciences, Giessen, Germany.'}, {'ForeName': 'Keywan', 'Initials': 'K', 'LastName': 'Sohrabi', 'Affiliation': 'Faculty of Health Sciences, University of Applied Sciences, Giessen, Germany.'}, {'ForeName': 'Winfried', 'Initials': 'W', 'LastName': 'Banzer', 'Affiliation': 'Department of Preventive and Sports Medicine, Institute for Occupational, Social and Environmental Medicine, Goethe University Frankfurt am Main, Germany.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Groß', 'Affiliation': 'Faculty of Health Sciences, University of Applied Sciences, Giessen, Germany.'}, {'ForeName': 'Lutz', 'Initials': 'L', 'LastName': 'Vogt', 'Affiliation': 'Department of Sports Medicine, Goethe University Frankfurt am Main, Germany.'}]","Clinical biomechanics (Bristol, Avon)",['10.1016/j.clinbiomech.2020.105175']
2896,32956906,Reality check: An experimental manipulation of inferential confusion in eating disorders.,"BACKGROUND AND OBJECTIVES


Inferential confusion (IC) entails confusing an imagined possibility with a sensory-based possibility, and acting upon the imagined possibility as if it was real. Although IC was formulated in the context of obsessive-compulsive disorder (OCD), this reasoning bias has shown to be relevant to other obsessive-compulsive spectrum disorders, such as eating disorders (EDs). The goal of this study was to induce IC experimentally in individuals with EDs relative to healthy controls (HC).
METHODS


Thirty-six women (ED group, n = 18; HC group, n = 18) were assigned to one of two experimental conditions: in the High IC condition, participants watched ED-themed videos with key sequences missing - provoking a distrust of the senses and lending more space for the imagination, thus triggering IC. In the Low IC condition, participants watched videos without sequences missing. Participants completed measures of IC, negative affect and compulsive behaviors after watching the videos.
RESULTS


One-way ANOVA indicated that ED participants assigned to the High IC condition reported a greater urge to engage in compulsive behaviors. ED participants also neutralized more after watching the videos and endorsed higher trait IC.
LIMITATIONS


There was no clinical control group.
CONCLUSIONS


These findings suggest that individuals with EDs display a greater vulnerability to IC, as they are more prone to compulsive behaviors when IC is triggered. This investigation may foster our understanding of the relationship between EDs and OCD through the examination of cognitive factors that are implicated in both disorders.",2020,ANOVA indicated that ED participants assigned to the High IC condition reported a greater urge to engage in compulsive behaviors.,"['Thirty-six women (ED group, n\xa0=\xa018', 'individuals with EDs relative to healthy controls (HC', 'eating disorders']","['watched ED-themed videos with key sequences missing - provoking a distrust of the senses and lending more space for the imagination, thus triggering IC']","['urge to engage in compulsive behaviors', 'IC, negative affect and compulsive behaviors']","[{'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0013473', 'cui_str': 'Eating disorder'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C1867020', 'cui_str': 'Scalp, ear, nipple syndrome'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0020913', 'cui_str': 'Use of imagination'}, {'cui': 'C0032930', 'cui_str': 'Precipitating Factors'}, {'cui': 'C0009676', 'cui_str': 'Confusional state'}]","[{'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0600104', 'cui_str': 'Compulsive behavior'}, {'cui': 'C0009676', 'cui_str': 'Confusional state'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001721', 'cui_str': 'Affect'}]",36.0,0.0589645,ANOVA indicated that ED participants assigned to the High IC condition reported a greater urge to engage in compulsive behaviors.,"[{'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Ouellet-Courtois', 'Affiliation': 'OCD Spectrum Study Center, Montreal Mental Health University Institute, 7331 Hochelaga Montreal, Quebec, H1N 3V2, Canada; Université de Montréal, Psychology Department, Canada. Electronic address: catherine.ouellet-courtois@umontreal.ca.'}, {'ForeName': 'Frederick', 'Initials': 'F', 'LastName': 'Aardema', 'Affiliation': 'OCD Spectrum Study Center, Montreal Mental Health University Institute, 7331 Hochelaga Montreal, Quebec, H1N 3V2, Canada; Université de Montréal, Psychiatry Department, 2900, Boul. Édouard-Montpetit Montreal, Quebec, H3T 1J4, Canada.'}, {'ForeName': 'Kieron', 'Initials': 'K', 'LastName': ""O'Connor"", 'Affiliation': 'OCD Spectrum Study Center, Montreal Mental Health University Institute, 7331 Hochelaga Montreal, Quebec, H1N 3V2, Canada; Université de Montréal, Psychiatry Department, 2900, Boul. Édouard-Montpetit Montreal, Quebec, H3T 1J4, Canada.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101614']
2897,32956960,Mental health promotion and prevention interventions in families with parental depression: A randomized controlled trial.,"BACKGROUND


The transgenerational transmission of affective disorders calls for integrating promotion of child development in the services offered to families with parental depression. The main objective of the present research was to examine the effectiveness and differences in the impact of two relevant interventions in Greece.
METHODS


Thirty families of depressed patients were randomly assigned to the six-to-eight session Family Talk Intervention group and 32 families were included in the lower intensity parent-only two-to-three session Let's Talk about the Children group. Depressed parents and the eldest of their children were assessed prior to the interventions and 4, 10, and 18 months following baseline assessment.
RESULTS


In both groups there were significant improvements in parent's depression, anxiety, perceived social support, parenting and family functioning, as well as improvements in child's depression, anxiety, and child emotional/behavioral problems. Child's prosocial behavior, perceived social support, and health-related quality of life were significantly improved in both groups. All positive effects were evident four months following baseline assessment and could be still documented at 1.5-year follow-up. Mixed linear models showed that family functioning and parenting to a lesser extent were associated with the greatest changes in children's psychosocial outcomes in both interventions..
LIMITATIONS


The lack of data regarding parents that refused to receive the interventions may limit generalizability of results. A further limitation is the lack of a no-intervention control group.
CONCLUSIONS


The study offers a preliminary evidence base for integrating preventive interventions for child mental health in routine clinical practice with adult depressed patients.",2020,"In both groups there were significant improvements in parent's depression, anxiety, perceived social support, parenting and family functioning, as well as improvements in child's depression, anxiety, and child emotional/behavioral problems.","['families with parental depression', 'Thirty families of depressed patients', 'child mental health in routine clinical practice with adult depressed patients']","['Mental health promotion and prevention interventions', 'six-to-eight session Family Talk Intervention group and 32 families were included in the lower intensity parent-only two-to-three session']","[""parent's depression, anxiety, perceived social support, parenting and family functioning, as well as improvements in child's depression, anxiety, and child emotional/behavioral problems"", ""Child's prosocial behavior, perceived social support, and health-related quality of life""]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0184645', 'cui_str': 'Mental health promotion'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0030551', 'cui_str': 'Parent'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0680051', 'cui_str': 'Family functioning capacity'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",32.0,0.0624,"In both groups there were significant improvements in parent's depression, anxiety, perceived social support, parenting and family functioning, as well as improvements in child's depression, anxiety, and child emotional/behavioral problems.","[{'ForeName': 'George', 'Initials': 'G', 'LastName': 'Giannakopoulos', 'Affiliation': 'Department of Child Psychiatry, School of Medicine, National and Kapodistrian University of Athens, ""Aghia Sophia"" Children\'s Hospital, Athens, Greece. Electronic address: ggiannak@med.uoa.gr.'}, {'ForeName': 'Tytti', 'Initials': 'T', 'LastName': 'Solantaus', 'Affiliation': 'MIELI Mental Health Finland, Helsinki, Finland; Finnish Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'Chara', 'Initials': 'C', 'LastName': 'Tzavara', 'Affiliation': 'Department of Child Psychiatry, School of Medicine, National and Kapodistrian University of Athens, ""Aghia Sophia"" Children\'s Hospital, Athens, Greece.'}, {'ForeName': 'Gerasimos', 'Initials': 'G', 'LastName': 'Kolaitis', 'Affiliation': 'Department of Child Psychiatry, School of Medicine, National and Kapodistrian University of Athens, ""Aghia Sophia"" Children\'s Hospital, Athens, Greece.'}]",Journal of affective disorders,['10.1016/j.jad.2020.09.070']
2898,32957522,"Vitamin C and E Treatment Blunts Sprint Interval Training-Induced Changes in Inflammatory Mediator-, Calcium-, and Mitochondria-Related Signaling in Recreationally Active Elderly Humans.","Sprint interval training (SIT) has emerged as a time-efficient training regimen for young individuals. Here, we studied whether SIT is effective also in elderly individuals and whether the training response was affected by treatment with the antioxidants vitamin C and E. Recreationally active elderly (mean age 65) men received either vitamin C (1 g/day) and vitamin E (235 mg/day) or placebo. Training consisted of nine SIT sessions (three sessions/week for three weeks of 4-6 repetitions of 30-s all-out cycling sprints) interposed by 4 min rest. Vastus lateralis muscle biopsies were taken before, 1 h after, and 24 h after the first and last SIT sessions. At the end of the three weeks of training, SIT-induced changes in relative mRNA expression of reactive oxygen/nitrogen species (ROS)- and mitochondria-related proteins, inflammatory mediators, and the sarcoplasmic reticulum Ca 2+  channel, the ryanodine receptor 1 (RyR1), were blunted in the vitamin treated group. Western blots frequently showed a major (>50%) decrease in the full-length expression of RyR1 24 h after SIT sessions; in the trained state, vitamin treatment seemed to provide protection against this severe RyR1 modification. Power at exhaustion during an incremental cycling test was increased by ~5% at the end of the training period, whereas maximal oxygen uptake remained unchanged; vitamin treatment did not affect these measures. In conclusion, treatment with the antioxidants vitamin C and E blunts SIT-induced cellular signaling in skeletal muscle of elderly individuals, while the present training regimen was too short or too intense for the changes in signaling to be translated into a clear-cut change in physical performance.",2020,"At the end of the three weeks of training, SIT-induced changes in relative mRNA expression of reactive oxygen/nitrogen species (ROS)- and mitochondria-related proteins, inflammatory mediators, and the sarcoplasmic reticulum Ca 2+  channel, the ryanodine receptor 1 (RyR1), were blunted in the vitamin treated group.","['young individuals', 'elderly individuals', 'skeletal muscle of elderly individuals', 'and E. Recreationally active elderly (mean age 65) men']","['vitamin E', 'SIT', 'antioxidants vitamin C and E blunts SIT', 'antioxidants vitamin C', 'placebo', 'Sprint interval training (SIT', 'Vitamin C and E Treatment Blunts Sprint', 'vitamin C']","['relative mRNA expression of reactive oxygen/nitrogen species (ROS)- and mitochondria-related proteins, inflammatory mediators', 'maximal oxygen uptake', 'full-length expression']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C4279979', 'cui_str': 'Sprint Interval Training'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C1997138', 'cui_str': 'Blunted'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0028158', 'cui_str': 'Nitrogen'}, {'cui': 'C0026237', 'cui_str': 'Mitochondrion'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C1444754', 'cui_str': 'Length'}]",,0.0596438,"At the end of the three weeks of training, SIT-induced changes in relative mRNA expression of reactive oxygen/nitrogen species (ROS)- and mitochondria-related proteins, inflammatory mediators, and the sarcoplasmic reticulum Ca 2+  channel, the ryanodine receptor 1 (RyR1), were blunted in the vitamin treated group.","[{'ForeName': 'Victoria L', 'Initials': 'VL', 'LastName': 'Wyckelsma', 'Affiliation': 'Department of Physiology and Pharmacology, Karolinska Institutet, 171 77 Stockholm, Sweden.'}, {'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Venckunas', 'Affiliation': 'Institute of Sport Science and Innovations, Lithuanian Sports University, 44221 Kaunas, Lithuania.'}, {'ForeName': 'Marius', 'Initials': 'M', 'LastName': 'Brazaitis', 'Affiliation': 'Institute of Sport Science and Innovations, Lithuanian Sports University, 44221 Kaunas, Lithuania.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Gastaldello', 'Affiliation': 'Department of Physiology and Pharmacology, Karolinska Institutet, 171 77 Stockholm, Sweden.'}, {'ForeName': 'Audrius', 'Initials': 'A', 'LastName': 'Snieckus', 'Affiliation': 'Institute of Sport Science and Innovations, Lithuanian Sports University, 44221 Kaunas, Lithuania.'}, {'ForeName': 'Nerijus', 'Initials': 'N', 'LastName': 'Eimantas', 'Affiliation': 'Institute of Sport Science and Innovations, Lithuanian Sports University, 44221 Kaunas, Lithuania.'}, {'ForeName': 'Neringa', 'Initials': 'N', 'LastName': 'Baranauskiene', 'Affiliation': 'Institute of Sport Science and Innovations, Lithuanian Sports University, 44221 Kaunas, Lithuania.'}, {'ForeName': 'Andrejus', 'Initials': 'A', 'LastName': 'Subocius', 'Affiliation': 'Institute of Sport Science and Innovations, Lithuanian Sports University, 44221 Kaunas, Lithuania.'}, {'ForeName': 'Albertas', 'Initials': 'A', 'LastName': 'Skurvydas', 'Affiliation': 'Institute of Sport Science and Innovations, Lithuanian Sports University, 44221 Kaunas, Lithuania.'}, {'ForeName': 'Mati', 'Initials': 'M', 'LastName': 'Pääsuke', 'Affiliation': 'Institute of Sport Sciences and Physiotherapy, University of Tartu, 50090 Tartu, Estonia.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Gapeyeva', 'Affiliation': 'Institute of Sport Sciences and Physiotherapy, University of Tartu, 50090 Tartu, Estonia.'}, {'ForeName': 'Priit', 'Initials': 'P', 'LastName': 'Kaasik', 'Affiliation': 'Laboratory of Functional Morphology, University of Tartu, 50090 Tartu, Estonia.'}, {'ForeName': 'Reedik', 'Initials': 'R', 'LastName': 'Pääsuke', 'Affiliation': 'Department of Traumatology and Orthopaedics, Tartu University Hospital, 50090 Tartu, Estonia.'}, {'ForeName': 'Jaak', 'Initials': 'J', 'LastName': 'Jürimäe', 'Affiliation': 'Laboratory of Kinanthropometry; University of Tartu, 50090 Tartu, Estonia.'}, {'ForeName': 'Brigitte A', 'Initials': 'BA', 'LastName': 'Graf', 'Affiliation': 'Food and Nutrition Department of Health Professions, Faculty of Health, Manchester Metropolitan University, Manchester M1 5GF, UK.'}, {'ForeName': 'Bengt', 'Initials': 'B', 'LastName': 'Kayser', 'Affiliation': 'Institute of Sports Sciences, University of Lausanne, 1015 Lausanne, Switzerland.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Place', 'Affiliation': 'Institute of Sports Sciences, University of Lausanne, 1015 Lausanne, Switzerland.'}, {'ForeName': 'Daniel C', 'Initials': 'DC', 'LastName': 'Andersson', 'Affiliation': 'Department of Physiology and Pharmacology, Karolinska Institutet, 171 77 Stockholm, Sweden.'}, {'ForeName': 'Sigitas', 'Initials': 'S', 'LastName': 'Kamandulis', 'Affiliation': 'Institute of Sport Science and Innovations, Lithuanian Sports University, 44221 Kaunas, Lithuania.'}, {'ForeName': 'Håkan', 'Initials': 'H', 'LastName': 'Westerblad', 'Affiliation': 'Department of Physiology and Pharmacology, Karolinska Institutet, 171 77 Stockholm, Sweden.'}]","Antioxidants (Basel, Switzerland)",['10.3390/antiox9090879']
2899,32957929,Effects of different sufentanil target concentrations on the MAC BAR  of sevoflurane in patients with carbon dioxide pneumoperitoneum stimulus.,"BACKGROUND


This study aims to observe the effects of different target controlled plasma sufentanil concentrations on the minimum alveolar concentration (MAC) of sevoflurane for blocking adrenergic response (BAR) in patients undergoing laparoscopic cholecystectomy with carbon dioxide pneumoperitoneum stimulation.
METHODS


Eighty-five patients undergoing laparoscopic cholecystectomy, aged 30-65 years, with American Society of Anesthesiologists physical status I-II, were enrolled in this study. All the patients were randomly divided into 5 groups (S 0 , S 1 , S 2 , S 3 , S 4 ) with different sufentanil plasma target concentration (0.0, 0.1, 0.3, 0.5, 0.7 ng ml - 1 ). Anesthesia was induced by inhalation of 8% sevoflurane in 100% oxygen, and 0.6 mg kg - 1  of rocuronium was intravenously injected to facilitate the insertion of a laryngeal mask airway. The end-tidal sevoflurane concentration and sufentanil plasma target concentration were adjusted according to respective preset value in each group. The hemodynamic response to pneumoperitoneum stimulus was observed after the end-tidal sevoflurane concentration had been maintained stable at least for 15 min. The MAC BAR  of sevoflurane was measured by a sequential method. Meanwhile, epinephrine (E) and norepinephrine (NE) concentrations in the blood were also determined before and after pneumoperitoneum stimulus in each group.
RESULTS


When the method of independent paired reversals was used, the MAC BAR  of sevoflurane in groups S 0 , S 1 , S 2 , S 3 , S 4  was 5.333% (confidence interval [CI] 95%: 5.197-5.469%), 4.533% (95% CI: 4.451-4.616%), 2.861% (95% CI: 2.752-2.981%), 2.233% (95% CI: 2.142-2.324%) and 2.139% (95% CI: 2.057-2.219%), respectively. Meanwhile, when the isotonic regression analysis was used, the MAC BAR  of sevoflurane in groups S 0 , S 1 , S 2 , S 3 , S 4  was 5.329% (95% CI: 5.321-5.343%), 4.557% (95% CI: 4.552-4.568%), 2.900% (95% CI: 2.894-2.911%), 2.216% (95% CI: 2.173-2.223%) and 2.171% (95% CI: 2.165-2.183%), respectively. The MAC BAR  was not significantly different between groups S 3  and S 4  when using 0.5 and 0.7 ng ml - 1  of sufentanil plasma target concentrations. No significant difference was found in the change of E or NE concentration between before and after pneumoperitoneum stimulation in each group.
CONCLUSIONS


The MAC BAR  of sevoflurane can be decreased with increasing sufentanil plasma target concentrations. A ceiling effect of the decrease occurred at a sufentanil plasma target concentration of 0.5 ng ml - 1 . When the sympathetic adrenergic response was inhibited in half of the patients to pneumoperitoneum stimulation in each group, the changes of E and NE concentrations showed no significant differences.
TRIAL REGISTRATION


The study was registered at http://www.chictr.org.cn ( ChiCTR1800015819 , 23, April, 2018).",2020,The MAC BAR  was not significantly different between groups S 3  and S 4  when using 0.5 and 0.7 ng ml - 1  of sufentanil plasma target concentrations.,"['Eighty-five patients undergoing laparoscopic cholecystectomy, aged 30-65\u2009years, with American Society of Anesthesiologists physical status I-II', 'patients undergoing laparoscopic cholecystectomy with carbon dioxide pneumoperitoneum stimulation', 'patients with carbon dioxide pneumoperitoneum stimulus']","['rocuronium', 'sufentanil', 'sevoflurane']","['Meanwhile, epinephrine (E) and norepinephrine (NE) concentrations', 'MAC BAR', 'sympathetic adrenergic response', 'change of E or NE concentration', 'end-tidal sevoflurane concentration and sufentanil plasma target concentration', 'MAC BAR  of sevoflurane', 'hemodynamic response to pneumoperitoneum stimulus']","[{'cui': 'C4517892', 'cui_str': '85'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0032320', 'cui_str': 'Pneumoperitoneum'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}]","[{'cui': 'C0209337', 'cui_str': 'Rocuronium'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}]","[{'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1959953', 'cui_str': 'End tidal sevoflurane concentration'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0032320', 'cui_str': 'Pneumoperitoneum'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}]",85.0,0.155202,The MAC BAR  was not significantly different between groups S 3  and S 4  when using 0.5 and 0.7 ng ml - 1  of sufentanil plasma target concentrations.,"[{'ForeName': 'Yanxia', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Department of Anaesthesiology, Affiliated Hospital of North Sichuan Medical College, Nanchong, 637000, Sichuan, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Department of Anaesthesiology, Affiliated Hospital of North Sichuan Medical College, Nanchong, 637000, Sichuan, China.'}, {'ForeName': 'Xiaolin', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Department of Anaesthesiology, Affiliated Hospital of North Sichuan Medical College, Nanchong, 637000, Sichuan, China. 879921874@qq.com.'}, {'ForeName': 'Pingping', 'Initials': 'P', 'LastName': 'Jiang', 'Affiliation': 'Department of Anaesthesiology, Affiliated Hospital of North Sichuan Medical College, Nanchong, 637000, Sichuan, China.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Department of Anaesthesiology, Affiliated Hospital of North Sichuan Medical College, Nanchong, 637000, Sichuan, China.'}, {'ForeName': 'Guoyuan', 'Initials': 'G', 'LastName': 'Zhang', 'Affiliation': 'Department of Clinical Laboratory, Affiliated Hospital of North Sichuan Medical College, Nanchong, 637000, Sichuan, China.'}]",BMC anesthesiology,['10.1186/s12871-020-01160-1']
2900,32958702,Early Intervention with Lenalidomide in Patients with High-risk Chronic Lymphocytic Leukemia.,"PURPOSE


Infectious complications constitute a leading cause of morbidity and mortality in chronic lymphocytic leukemia (CLL). Patients respond poorly to vaccines, particularly pneumococcal polysaccharide and influenza vaccines. In addition, patients with genetically high-risk disease are at increased risk for early disease progression and death. Lenalidomide, an oral immunomodulatory agent with demonstrated clinical activity in CLL, can potentially restore immune system dysfunction associated with CLL while improving disease outcomes.
PATIENTS AND METHODS


Phase II study randomized 49 patients with genetically high-risk CLL or small lymphocytic lymphoma [SLL; defined as unmutated Ig heavy chain variable region, deletion(17p) or (11q), and/or complex abnormal karyotype], to receive lenalidomide either concurrent (arm A) or sequential to (arm B) two doses of 13-valent protein-conjugated pneumococcal vaccine (PCV13) administered 2 months apart, in patients not meeting International Workshop on Chronic Lymphocytic Leukemia treatment criteria.
RESULTS


Four serotypes (3, 4, 5, 6B) achieved the additional seroprotection definition of a fourfold increase in arm A, and six serotypes (3, 4, 5, 6B, 19A, 19F) in arm B. All patients achieved the defined concentration of 0.35 μg/mL for at least one serotype tested. No significant difference was observed with the addition of lenalidomide. At median time on treatment of 3.6 years, median progression-free survival (PFS) was 5.8 years [95% confidence interval (CI), 3.1-not reached]. PFS at 1, 2, and 3 years was 85% (95% CI, 72-93), 79% (95% CI, 64-88), and 72% (95% CI, 57-83), respectively.
CONCLUSIONS


Lenalidomide is efficacious with manageable toxicities as an early intervention strategy in patients with high-risk CLL, but did not enhance humoral response to PCV13 vaccine.",2020,"PFS at 1, 2 and 3 year was 85% (95% CI 72-93), 79% (64-88), and 72% (95% CI 57-83) respectively.
","['chronic lymphocytic leukemia (CLL', '49 patients with genetically high-risk CLL or SLL (defined as unmutated IGHV, deletion(17p) or (11q), and/or complex abnormal karyotype', 'patients with high-risk chronic lymphocytic leukemia', 'patients with high-risk CLL', 'patients with genetically high risk disease']","['lenalidomide', 'lenalidomide either concurrent (Arm A) or sequential to (Arm B) 2 doses of 13-valent protein-conjugated pneumococcal vaccine (PCV13', 'Lenalidomide']","['risk for early disease progression and death', 'additional seroprotection definition', 'PFS', 'median PFS']","[{'cui': 'C0023434', 'cui_str': 'Chronic lymphocytic leukemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0855095', 'cui_str': 'Malignant lymphoma, small lymphocytic'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0008628', 'cui_str': 'Chromosomal deletion'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0476431', 'cui_str': 'Karyotype evaluation abnormal'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0301869', 'cui_str': 'Conjugate'}, {'cui': 'C0358314', 'cui_str': 'Pneumococcal vaccine'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",49.0,0.160773,"PFS at 1, 2 and 3 year was 85% (95% CI 72-93), 79% (64-88), and 72% (95% CI 57-83) respectively.
","[{'ForeName': 'Shanmugapriya', 'Initials': 'S', 'LastName': 'Thangavadivel', 'Affiliation': 'Division of Hematology, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio.'}, {'ForeName': 'Qiuhong', 'Initials': 'Q', 'LastName': 'Zhao', 'Affiliation': 'Division of Hematology, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio.'}, {'ForeName': 'Narendranath', 'Initials': 'N', 'LastName': 'Epperla', 'Affiliation': 'Division of Hematology, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio.'}, {'ForeName': 'Lindsey', 'Initials': 'L', 'LastName': 'Rike', 'Affiliation': 'Division of Hematology, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio.'}, {'ForeName': 'Xiaokui', 'Initials': 'X', 'LastName': 'Mo', 'Affiliation': 'Division of Hematology, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Badawi', 'Affiliation': 'Division of Hematology, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio.'}, {'ForeName': 'Darlene M', 'Initials': 'DM', 'LastName': 'Bystry', 'Affiliation': 'Division of Hematology, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio.'}, {'ForeName': 'Mitch A', 'Initials': 'MA', 'LastName': 'Phelps', 'Affiliation': 'Division of Hematology, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio.'}, {'ForeName': 'Leslie A', 'Initials': 'LA', 'LastName': 'Andritsos', 'Affiliation': 'Division of Hematology, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio.'}, {'ForeName': 'Kerry A', 'Initials': 'KA', 'LastName': 'Rogers', 'Affiliation': 'Division of Hematology, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Jones', 'Affiliation': 'Division of Hematology, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Woyach', 'Affiliation': 'Division of Hematology, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Byrd', 'Affiliation': 'Division of Hematology, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio. farrukh.awan@utsouthwestern.edu john.byrd@osumc.edu.'}, {'ForeName': 'Farrukh T', 'Initials': 'FT', 'LastName': 'Awan', 'Affiliation': 'Harold C. Simmons Comprehensive Cancer Center, University of Texas Southwestern Medical Center, Dallas, Texas. farrukh.awan@utsouthwestern.edu john.byrd@osumc.edu.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-1280']
2901,32960272,CYP2B6 Genotype and Weight Gain Differences Between Dolutegravir and Efavirenz.,"BACKGROUND


Dolutegravir is associated with more weight gain than efavirenz. Loss-of-function polymorphisms in CYP2B6 result in higher efavirenz concentrations, which we hypothesized would impair weight gain among people living with human immunodeficiency virus (HIV; PLWH) starting efavirenz-based antiretroviral therapy (ART).
METHODS


We studied ART-naive participants from the ADVANCE study randomized to the efavirenz /emtricitabine/tenofovir disoproxil fumarate (TDF) and dolutegravir/emtricitabine/TDF arms. We compared changes in weight and regional fat on DXA from baseline to week 48 between CYP2B6 metabolizer genotypes in the efavirenz arm, and with the dolutegravir arm.
RESULTS


There were 342 participants in the dolutegravir arm and 168 in the efavirenz arm who consented to genotyping. Baseline characteristics were similar. Weight gain was greater in women than men. In the efavirenz arm CYP2B6 metaboliser genotype was associated with weight gain (P = .009), with extensive metabolizers gaining the most weight, and with changes in regional fat in women, but not in men. Weight gain was similar in CYP2B6 extensive metabolizers in the efavirenz arm and in the dolutegravir arm (P = .836). The following variables were independently associated with weight gain in all participants: baseline CD4 count, baseline human immunodeficiency virus type 1 (HIV-1) RNA, and CYP2B6 metaboliser genotype.
CONCLUSIONS


CYP2B6 metaboliser genotype was associated with weight gain in PLWH starting efavirenz-based ART. Weight gain was similar between CYP2B6 extensive metabolizers in the efavirenz arm and in the dolutegravir arm, suggesting that impaired weight gain among CYP2B6 slow or intermediate metabolizers could explain the increased weight gain on dolutegravir compared with efavirenz observed in ADVANCE and other studies.",2020,"In the efavirenz arm CYP2B6 metaboliser genotype was associated with weight gain (P = .009), with extensive metabolizers gaining the most weight, and with changes in regional fat in women, but not in men.","['342 participants in the dolutegravir arm and 168 in the efavirenz arm who consented to genotyping', 'people living with human immunodeficiency virus (HIV; PLWH) starting efavirenz-based antiretroviral therapy (ART']","['efavirenz /emtricitabine/tenofovir disoproxil fumarate (TDF) and dolutegravir/emtricitabine/TDF arms', 'efavirenz', 'Efavirenz']","['weight gain', 'Weight gain', 'weight and regional fat on DXA', 'CYP2B6 Genotype and Weight Gain Differences', 'baseline CD4 count, baseline human immunodeficiency virus type 1 (HIV-1) RNA, and CYP2B6 metaboliser genotype']","[{'cui': 'C5191280', 'cui_str': '342'}, {'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C0674428', 'cui_str': 'efavirenz'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]","[{'cui': 'C0674428', 'cui_str': 'efavirenz'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C2929052', 'cui_str': 'tenofovir disoproxil and emtricitabine'}, {'cui': 'C0016801', 'cui_str': 'Fumarates'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0534137', 'cui_str': 'CYP2B6 protein, human'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}, {'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C0035668', 'cui_str': 'RNA'}]",342.0,0.122371,"In the efavirenz arm CYP2B6 metaboliser genotype was associated with weight gain (P = .009), with extensive metabolizers gaining the most weight, and with changes in regional fat in women, but not in men.","[{'ForeName': 'Rulan', 'Initials': 'R', 'LastName': 'Griesel', 'Affiliation': 'Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Maartens', 'Affiliation': 'Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Maxwell', 'Initials': 'M', 'LastName': 'Chirehwa', 'Affiliation': 'Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Simiso', 'Initials': 'S', 'LastName': 'Sokhela', 'Affiliation': 'Ezintsha, Wits Reproductive Health and HIV Institute, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Godspower', 'Initials': 'G', 'LastName': 'Akpomiemie', 'Affiliation': 'Ezintsha, Wits Reproductive Health and HIV Institute, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Moorhouse', 'Affiliation': 'Ezintsha, Wits Reproductive Health and HIV Institute, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Francois', 'Initials': 'F', 'LastName': 'Venter', 'Affiliation': 'Ezintsha, Wits Reproductive Health and HIV Institute, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Phumla', 'Initials': 'P', 'LastName': 'Sinxadi', 'Affiliation': 'Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciaa1073']
2902,32965238,School-Based Multicomponent Intervention to Promote Physical Activity and Reduce Sedentary Time of Disadvantaged Children Aged 6-10 Years: Protocol for a Randomized Controlled Trial.,"BACKGROUND


In our modern society, physical activity (PA) is decreasing and sedentary time (ST) is increasing, especially for children from disadvantaged neighborhoods. School-based interventions to promote PA and decrease ST are therefore required among this population in order to change children's lifestyle habits. Moreover, attentional capacities and academic achievement can be enhanced by chronic PA during childhood. The relationships between these variables have been poorly studied with this population.
OBJECTIVE


The objective of this study is to present the rationale and methods for a randomized controlled trial among 6-10-year-old children with low socioeconomic status that will (1) evaluate the effectiveness of a school-based intervention designed to promote PA and reduce ST and (2) study the relationships between PA, ST, motor skills, attentional capacities, and academic achievement.
METHODS


A randomized controlled trial was conducted in 2 eligible primary schools. During academic year 2016-2017, 1 school was randomly assigned as the experiment one and the other was assigned as the control one. Five assessments times were used: baseline (T1 [November 2016] to T2 [June 2017]), follow-up (T3 [November 2017] to T4 [June 2018]), and final assessment (T5 [June 2019]). The school-based intervention included various components on different levels of the socioecological model: (1) curriculum-based program for children; (2) sensitization workshops and newsletters for parents; (3) training workshops for teachers; (4) environmental adaptation of playgrounds and reorganization of recess time; (5) time adaptation of lunch breaks; and (6) collaboration with political groups. PA, ST, motor skills, and attentional capacities were evaluated and academic achievement was recorded.
RESULTS


The presented intervention and its different assessments have been successfully implemented. In order to achieve the 2 objectives of this randomized controlled trial, data analyses are about to be completed.
CONCLUSIONS


The implementation of this randomized controlled trial can help to determine effective strategies to promote PA in the context of increasing prevalence of physical inactivity among children with sedentary lifestyle which will be useful for researchers, stakeholders, and public policy makers.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03983447; https://clinicaltrials.gov/ct2/show/NCT03983447.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


RR1-10.2196/17815.",2020,School-based interventions to promote PA and decrease ST are therefore required among this population in order to change children's lifestyle habits.,"['children with sedentary lifestyle', '6-10-year-old children with low socioeconomic status that will (1', 'children from disadvantaged neighborhoods', '2 eligible primary schools', 'Aged 6-10 Years', 'During academic year 2016-2017, 1 school', 'Disadvantaged Children']","['School-Based Multicomponent Intervention', 'socioecological model: (1) curriculum-based program for children; (2) sensitization workshops and newsletters for parents; (3) training workshops for teachers; (4) environmental adaptation of playgrounds and reorganization of recess time; (5) time adaptation of lunch breaks; and (6) collaboration with political groups']","['PA, ST, motor skills, attentional capacities, and academic achievement', 'attentional capacities and academic achievement', 'PA, ST, motor skills, and attentional capacities']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1532253', 'cui_str': 'Sedentary lifestyle'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0086996', 'cui_str': 'Socioeconomic Status'}, {'cui': 'C0012613', 'cui_str': 'Disadvantaged'}, {'cui': 'C0027569', 'cui_str': 'Neighborhood'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1325847', 'cui_str': 'Sensitization'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0027988', 'cui_str': 'Newsletters'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0178620', 'cui_str': 'Environmental adaptation'}, {'cui': 'C0442596', 'cui_str': 'School playground'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C2697949', 'cui_str': 'Lunch'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0026612', 'cui_str': 'Motor Skills'}, {'cui': 'C0013658', 'cui_str': 'Educational achievement'}]",2.0,0.106121,School-based interventions to promote PA and decrease ST are therefore required among this population in order to change children's lifestyle habits.,"[{'ForeName': 'Caroline Maite Marie', 'Initials': 'CMM', 'LastName': 'Bernal', 'Affiliation': ""Universite de Pau & des Pays de l'Adour, e2s UPPA, MEPS, Tarbes, France.""}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Lhuisset', 'Affiliation': ""Universite de Pau & des Pays de l'Adour, e2s UPPA, MEPS, Tarbes, France.""}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Fabre', 'Affiliation': ""Universite de Pau & des Pays de l'Adour, e2s UPPA, MEPS, Tarbes, France.""}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Bois', 'Affiliation': ""Universite de Pau & des Pays de l'Adour, e2s UPPA, MEPS, Tarbes, France.""}]",JMIR research protocols,['10.2196/17815']
2903,32965539,"A placebo-controlled, double-blind, randomized study of recombinant thrombomodulin (ART-123) to prevent oxaliplatin-induced peripheral neuropathy.","PURPOSE


The purpose of this clinical study was to be the first to explore whether ART-123, a recombinant human soluble thrombomodulin, prevents oxaliplatin-induced peripheral neuropathy (OIPN).
METHODS


This randomized, phase IIa trial enrolled stage II/III colon cancer patients who received adjuvant mFOLFOX6 chemotherapy. Participants were randomly allocated to 3 arms in a double-blind manner: placebo (placebo: days 1-3); 1-day ART (ART-123: day 1, placebo: days 2-3); and 3-day ART (ART-123: days 1-3). ART-123 (380 U/kg/day) or placebo was infused intravenously before each 2-week cycle of mFOLFOX6. OIPN was assessed with the Functional Assessment of Cancer Therapy/Gynecological Oncology Group-Neurotoxicity-12 (FACT/GOG-Ntx-12) score by participants and the NCI Common Terminology Criteria for Adverse Events (NCI-CTCAE) by investigators.
RESULTS


Seventy-nine participants (placebo n = 28, 1-day ART n = 27, 3-day ART n = 24) received study drugs. The least-squares mean FACT/GOG-Ntx-12 scores at cycle 12 from the mixed effect model for repeated measures were 28.9 with placebo, 36.3 with 1-day ART (vs. placebo: 7.3 [95% CI 1.9 to12.8, p = 0.009]), and 32.3 with 3-day ART (vs. placebo: 3.4 [95% CI -.1 to 9.0, p = 0.222]). The cumulative incidence of NCI-CTCAE grade ≥ 2 sensory neuropathy at cycle 12 was 64.3% with placebo, 40.7% with 1-day ART (vs. placebo: -23.5 [95% CI -48.4 to 4.0], p = 0.108), and 45.8% with 3-day ART (vs. placebo: -18.5 [95% CI -44.2 to 9.4], p = 0.264). Common adverse events were consistent with those reported with mFOLFOX6; no severe bleeding adverse events occurred.
CONCLUSION


ART-123 showed a potential preventive effect against OIPN with good tolerability. A larger study with 1-day ART is warranted. NCT02792842, registration date: June 8, 2016.",2020,"The cumulative incidence of NCI-CTCAE grade ≥ 2 sensory neuropathy at cycle 12 was 64.3% with placebo, 40.7% with 1-day ART (vs. placebo: -23.5","['Seventy-nine participants (placebo n\u2009=\u200928, 1-day ART n\u2009=\u200927, 3-day ART n\u2009=\u200924) received study drugs', 'III colon cancer patients who received']","['ART-123', 'placebo', 'recombinant thrombomodulin (ART-123', 'adjuvant mFOLFOX6 chemotherapy', 'placebo (placebo: days 1-3); 1-day ART (ART-123: day 1, placebo']","['OIPN', 'severe bleeding adverse events', 'Neurotoxicity-12 (FACT/GOG-Ntx-12) score', 'cumulative incidence of NCI-CTCAE grade\u2009≥\u20092 sensory neuropathy']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0007102', 'cui_str': 'Malignant tumor of colon'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1174887', 'cui_str': 'ART123'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0145779', 'cui_str': 'Thrombomodulin'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0003826', 'cui_str': 'Arts'}]","[{'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C1869037', 'cui_str': 'Peripheral neuropathy (SMQ)'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0235032', 'cui_str': 'Neurotoxicity'}, {'cui': 'C0285526', 'cui_str': 'N-telopeptide'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0560007', 'cui_str': 'nCi'}, {'cui': 'C1516728', 'cui_str': 'National Cancer Institute common terminology criteria for adverse events'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0151313', 'cui_str': 'Sensory neuropathy'}]",,0.727589,"The cumulative incidence of NCI-CTCAE grade ≥ 2 sensory neuropathy at cycle 12 was 64.3% with placebo, 40.7% with 1-day ART (vs. placebo: -23.5","[{'ForeName': 'Masahito', 'Initials': 'M', 'LastName': 'Kotaka', 'Affiliation': 'Gastrointestinal Cancer Center, Sano Hospital, 2-5-1 Shimizugaoka, Tarumi-ku, Kobe-shi, Hyogo, 655-0031, Japan. tomomakotaka6410@yahoo.co.jp.'}, {'ForeName': 'Yoji', 'Initials': 'Y', 'LastName': 'Saito', 'Affiliation': 'Department of Anesthesiology, Shimane University Faculty of Medicine, 89-1 Enyacho, Izumo City, Shimane, 693-8501, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Kato', 'Affiliation': 'Department of Gastroenterological Surgery, Kansai Rosai Hospital, 3-1-69 Inabaso, Amagasaki-shi, Hyogo, 660-8511, Japan.'}, {'ForeName': 'Hironaga', 'Initials': 'H', 'LastName': 'Satake', 'Affiliation': 'Department of Medical Oncology, Kobe City Medical Center General Hospital, 2-1-1 Minatojimaminamimachi, Chuo-ku, Kobe-city, Hyogo, 650-0047, Japan.'}, {'ForeName': 'Akitaka', 'Initials': 'A', 'LastName': 'Makiyama', 'Affiliation': 'Department of Hematology/Oncology, Japan Community Healthcare Organization Kyushu Hospital, 1-8-1 Kishinoura, Yahatanishi-ku, Kitakyusyu-shi, Fukuoka, 806-8501, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Tsuji', 'Affiliation': 'Department of Medical Oncology, Tonan Hospital, Kita 4-jo Nishi 7-chome 3-8, Chuo-ku, Sapporo-shi, Hokkaido, 060-0004, Japan.'}, {'ForeName': 'Katsunori', 'Initials': 'K', 'LastName': 'Shinozaki', 'Affiliation': 'Division of Clinical Oncology, Hiroshima Prefectural Hospital, 1-5-54 Ujinakanda, Minami-ku, Hiroshima-shi, Hiroshima, 734-8530, Japan.'}, {'ForeName': 'Toshiyoshi', 'Initials': 'T', 'LastName': 'Fujiwara', 'Affiliation': 'Department of Gastroenterological Surgery, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, 2-5-1 Shikata-cho, Kita-ku, Okayama-city, Okayama, 700-8558, Japan.'}, {'ForeName': 'Tsunekazu', 'Initials': 'T', 'LastName': 'Mizushima', 'Affiliation': 'Department of Gastrointestinal Surgery, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Harihara', 'Affiliation': 'Department of Surgery, NTT Medical Center Tokyo, 5-9-22 Higashi-Gotanda, Shinagawa-ku, Tokyo, 141-8625, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Nagata', 'Affiliation': 'Department of Surgery, Kitakyushu General Hospital, 1-1 Higashijono-machi, Kokurakita-ku, Kitakyushu, 802-8517, Japan.'}, {'ForeName': 'Naoto', 'Initials': 'N', 'LastName': 'Kurihara', 'Affiliation': 'Department of Surgery, Nerima General Hospital, 1-24-1 Asahigaoka, Nerima-ku, Tokyo, 176-8530, Japan.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Ando', 'Affiliation': 'Center for Advanced Medicine and Clinical Research, Nagoya University Hospital, 65 Tsurumai-cho, Showa-ku, Nagoya, 466-8560, Japan.'}, {'ForeName': 'Genichi', 'Initials': 'G', 'LastName': 'Kusakawa', 'Affiliation': 'Clinical Development Center, Asahi Kasei Pharma Corporation, 1-1-2 Yurakucho, Chiyoda-ku, Tokyo, 100-0006, Japan.'}, {'ForeName': 'Takumi', 'Initials': 'T', 'LastName': 'Sakai', 'Affiliation': 'Clinical Development Center, Asahi Kasei Pharma Corporation, 1-1-2 Yurakucho, Chiyoda-ku, Tokyo, 100-0006, Japan.'}, {'ForeName': 'Yugo', 'Initials': 'Y', 'LastName': 'Uchida', 'Affiliation': 'Clinical Development Center, Asahi Kasei Pharma Corporation, 1-1-2 Yurakucho, Chiyoda-ku, Tokyo, 100-0006, Japan.'}, {'ForeName': 'Mikihiro', 'Initials': 'M', 'LastName': 'Takamoto', 'Affiliation': 'Clinical Development Center, Asahi Kasei Pharma Corporation, 1-1-2 Yurakucho, Chiyoda-ku, Tokyo, 100-0006, Japan.'}, {'ForeName': 'Saki', 'Initials': 'S', 'LastName': 'Kimoto', 'Affiliation': 'Clinical Development Center, Asahi Kasei Pharma Corporation, 1-1-2 Yurakucho, Chiyoda-ku, Tokyo, 100-0006, Japan.'}, {'ForeName': 'Ichinosuke', 'Initials': 'I', 'LastName': 'Hyodo', 'Affiliation': 'Division of Gastroenterology, University of Tsukuba, 1-1-1 Tennodai, Tsukuba, Ibaraki, 305-8577, Japan.'}]",Cancer chemotherapy and pharmacology,['10.1007/s00280-020-04135-8']
2904,32965602,Correction to: Efficacy and safety results from a randomized double-blind study comparing proposed biosimilar ABP 798 with rituximab reference product in subjects with moderate-to-severe rheumatoid arthritis.,This article originally published with the family name and given names of all authors transposed.,2020,This article originally published with the family name and given names of all authors transposed.,['subjects with moderate-to-severe rheumatoid arthritis'],['biosimilar ABP 798 with rituximab reference product'],[],"[{'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}]","[{'cui': 'C4045974', 'cui_str': 'Biosimilars'}, {'cui': 'C0001239', 'cui_str': 'Actin-binding protein'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}]",[],,0.233974,This article originally published with the family name and given names of all authors transposed.,"[{'ForeName': 'Gerd', 'Initials': 'G', 'LastName': 'Burmester', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Free University and Humboldt University Berlin, Charité University Medicine Berlin, Charitéplatz 1, 10117, Berlin, Germany. gerd.burmester@charite.de.'}, {'ForeName': 'Edit', 'Initials': 'E', 'LastName': 'Drescher', 'Affiliation': 'Veszprém Csolnoky Ferenc County Hospital, Veszprém, Hungary.'}, {'ForeName': 'Pawel', 'Initials': 'P', 'LastName': 'Hrycaj', 'Affiliation': 'Rheumatology, Koscian Municipal Hospital, Koscian, Poland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Chien', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Zhiying', 'Initials': 'Z', 'LastName': 'Pan', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Cohen', 'Affiliation': 'Metroplex Clinical Research Center, Dallas, TX, USA.'}]",Clinical rheumatology,['10.1007/s10067-020-05410-y']
2905,32965655,"PSO-LONG: Design of a Novel, 12-Month Clinical Trial of Topical, Proactive Maintenance with Twice-Weekly Cal/BD Foam in Psoriasis.","BACKGROUND


Psoriasis vulgaris is commonly treated with topical corticosteroids and vitamin D analogues. Although potent and super-potent topical corticosteroids are very effective at clearing psoriasis, with short-term reactive treatment durations, symptoms usually recur after treatment discontinuation, necessitating long-term disease management strategies. A foam formulation of calcipotriol and betamethasone dipropionate (Cal/BD foam), consisting of calcipotriol 50 μg/g and betamethasone dipropionate 0.5 mg/g, is approved for the daily treatment of psoriasis for up to 4 weeks. Here, we describe a clinical trial protocol for evaluating the long-term safety and efficacy of twice-weekly Cal/BD foam as a proactive topical maintenance therapy for plaque psoriasis for up to 52 weeks.
OBJECTIVE


The aim of this trial was to evaluate the safety and efficacy of Cal/BD foam when applied twice weekly for up to 52 weeks as proactive maintenance therapy, with the goal of preventing or delaying disease relapse as long as possible while minimizing adverse effects.
METHODS


Once-daily Cal/BD foam treatment responders from an initial 4-week open-label period were randomized to receive Cal/BD foam or foam vehicle applied to previously cleared plaques twice weekly for up to 52 weeks. In case of relapse, affected subjects in either group received rescue therapy with once-daily Cal/BD foam for 4 weeks on active areas. Thus, the trial (NCT02899962) compared the long-term use of Cal/BD foam in a proactive approach with a conventional, reactive approach.
PLANNED OUTCOMES


Efficacy endpoints included the time to first relapse, the number of relapse-free days, and the number of relapses during the maintenance phase. Safety assessments included adverse events, incidence of rebound, local safety and tolerability scores, and effects on calcium metabolism and hypothalamic-pituitary-adrenal axis function.
TRIAL REGISTRATION


ClinicalTrials.gov identifier, NCT02899962.",2020,"Safety assessments included adverse events, incidence of rebound, local safety and tolerability scores, and effects on calcium metabolism and hypothalamic-pituitary-adrenal axis function.
","['plaque psoriasis for up to 52\xa0weeks', 'in Psoriasis']","['Topical, Proactive Maintenance with Twice-Weekly Cal/BD Foam', 'calcipotriol and betamethasone dipropionate (Cal/BD foam), consisting of calcipotriol 50\xa0μg', 'betamethasone dipropionate']","['adverse events, incidence of rebound, local safety and tolerability scores, and effects on calcium metabolism and hypothalamic-pituitary-adrenal axis function', 'safety and efficacy', 'time to first relapse, the number of relapse-free days, and the number of relapses']","[{'cui': 'C0406317', 'cui_str': 'Chronic small plaque psoriasis'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0991510', 'cui_str': 'Foam'}, {'cui': 'C0065767', 'cui_str': 'calcipotriene'}, {'cui': 'C0053523', 'cui_str': 'Betamethasone dipropionate'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0020663', 'cui_str': 'Hypothalamic structure'}, {'cui': 'C0032022', 'cui_str': 'Pituitary-Adrenal System'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",,0.0714231,"Safety assessments included adverse events, incidence of rebound, local safety and tolerability scores, and effects on calcium metabolism and hypothalamic-pituitary-adrenal axis function.
","[{'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Stein Gold', 'Affiliation': 'Department of Dermatology, Henry Ford Health System, Detroit, MI, USA.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Alonso-Llamazares', 'Affiliation': 'Department of Dermatology, VA Medical Center, Miami, FL, USA.'}, {'ForeName': 'Jean-Philippe', 'Initials': 'JP', 'LastName': 'Lacour', 'Affiliation': 'Department of Dermatology, University Hospital of Nice, Nice, France.'}, {'ForeName': 'Richard B', 'Initials': 'RB', 'LastName': 'Warren', 'Affiliation': 'Dermatology Centre, Salford Royal NHS Foundation Trust, NIHR Manchester BRC University of Manchester, Manchester, UK.'}, {'ForeName': 'Stephen K', 'Initials': 'SK', 'LastName': 'Tyring', 'Affiliation': 'Department of Dermatology, University of Texas Health Science Center, Houston, TX, USA.'}, {'ForeName': 'Leon', 'Initials': 'L', 'LastName': 'Kircik', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Yamauchi', 'Affiliation': 'Division of Dermatology, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Lebwohl', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA. lebwohl@aol.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Advances in therapy,['10.1007/s12325-020-01497-6']
2906,32960626,"Effects of a low-carbohydrate diet on body composition and performance in road cycling: a randomized, controlled trial.","Introduction


Low-carbohydrate diets are frequently used to improve performance in endurance sports, often with contradictory results. This study aimed to assess whether a low-carbohydrate diet can outperform an isocaloric conventional diet for improving body composition and performance in a sample of twenty-six trained male road cyclists (previous experience in cyclosportive events, 7.6 ± 4.4 years; age, 26.9 ± 4.9 years; weekly training volume, 7.8 ± 2.9 hours; height, 176 ± 7 centimeters; body fat percentage, 9.7 ± 0.8 %; weight, 65.3 ± 2.3 kg). Detraining and pretreatment periods in which nutrition and training were standardized were followed by an eight-week long intervention in which cyclists consumed either a low-carbohydrate diet (15 % of calories from carbohydrates) or a conventional endurance sports diet while maintaining the same training volumes and intensities. Body composition was assessed through electrical impedance, and performance was evaluated through a twenty-minute time trial performed on a smart bike trainer. The results revealed an overall improvement over time in absolute and relative power, body mass, and body fat for both groups, whilst the improvement in absolute power was comparable. The improvements seen in relative power (p = 0.042), body mass (p = 0.006), and body fat (p = 0.01) were significantly higher in the low-carbohydrate group. We concluded that eight weeks of a low-carbohydrate diet significantly reduced body weight and body fat percentage, and improved 20-minute relative power values in a sample of road cyclists when compared to an isocaloric conventional diet.",2020,"The improvements seen in relative power (p = 0.042), body mass (p = 0.006), and body fat (p = 0.01) were significantly higher in the low-carbohydrate group.","['road cycling', 'a sample of twenty-six trained male road cyclists (previous experience in cyclosportive events, 7.6 ± 4.4 years; age, 26.9 ± 4.9 years; weekly training volume, 7.8 ± 2.9 hours; height, 176 ± 7 centimeters; body fat percentage, 9.7 ± 0.8 %; weight, 65.3 ± 2.3 kg']","['low-carbohydrate diet', 'isocaloric conventional diet', 'Detraining and pretreatment periods in which nutrition and training were standardized were followed by an eight-week long intervention in which cyclists consumed either a low-carbohydrate diet (15 % of calories from carbohydrates) or a conventional endurance sports diet', 'Low-carbohydrate diets']","['relative power', 'body composition and performance', 'body fat', 'Body composition', 'body weight and body fat percentage', 'body mass', 'overall improvement over time in absolute and relative power, body mass, and body fat']","[{'cui': 'C0442650', 'cui_str': 'Road'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C4517761', 'cui_str': '4.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C4517641', 'cui_str': '2.9'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0475210', 'cui_str': 'cm'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]","[{'cui': 'C0259836', 'cui_str': 'Carbohydrate restricted diet'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0038039', 'cui_str': 'Sport'}]","[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}]",26.0,0.017905,"The improvements seen in relative power (p = 0.042), body mass (p = 0.006), and body fat (p = 0.01) were significantly higher in the low-carbohydrate group.","[{'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Sitko', 'Affiliation': 'Facultad de Ciencias de la Salud y del Deporte. Universidad de Zaragoza.'}, {'ForeName': 'Rafel', 'Initials': 'R', 'LastName': 'Cirer-Sastre', 'Affiliation': ""Institut Nacional d'Educació Física de Catalunya (INEFC). Universitat de Lleida (UdL).""}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Corbi', 'Affiliation': ""Institut Nacional d'Educació Física de Catalunya (INEFC). Universitat de Lleida (UdL).""}, {'ForeName': 'Isaac', 'Initials': 'I', 'LastName': 'López Laval', 'Affiliation': 'Facultad de Ciencias de la Salud y del Deporte. Universidad de Zaragoza.'}]",Nutricion hospitalaria,['10.20960/nh.03103']
2907,32960643,"Short-term branched-chain amino acid supplementation does not enhance vertical jump in professional volleyball players. A double-blind, controlled, randomized study.","Introduction


To the best of the authors' knowledge, no previous studies have described the effect of branched-chain amino acids (BCAA) on vertical performance during a week in professional volleyball players. This study assessed BCAA supplementation for a week, aiming to improve vertical jump performance in male professional volleyball players. Twelve male volleyballers were randomly assigned to a BCAA group (n = 6) or a control group (n = 6). The BCAA group ingested 21 g over a week, 7 g per day on Monday, Wednesday, and Friday, before a volleyball training session, while the control group drank a placebo drink. Participants performed 8 maximal countermovement jumps (CMJ); the 3 CMJs on Monday and Wednesday were evaluated after warm-up, after plyometric training, and at the end of the training session; and the 2 CMJs on Friday were evaluated after warm-up, and at the end of the training session. Compared with baseline, no significant differences in CMJ over the week were observed in BCAA or control group, neither between groups. The results indicated that 21 g of BCAA supplementation over a week did not improve vertical jump performance in professional volleyball players.",2020,"Compared with baseline, significant differences in CMJ over the week were seen neither in the BCAA group (p < 0.000; SE = 0.31) nor between groups.","['Twelve male volleyballers', 'male professional volleyball players', 'professional volleyball players']","['control group drank a placebo drink', 'branched-chain amino acids (BCAA', 'BCAA supplementation', 'Short-term branched-chain amino acid supplementation', 'BCAA']","['vertical jump performance', 'CMJ']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1956059', 'cui_str': 'Volleyball'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0002521', 'cui_str': 'Branched-chain amino acid'}, {'cui': 'C0556085', 'cui_str': 'Branched chain amino acid supplementation'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}]",12.0,0.0458344,"Compared with baseline, significant differences in CMJ over the week were seen neither in the BCAA group (p < 0.000; SE = 0.31) nor between groups.","[{'ForeName': 'Juan Pedro', 'Initials': 'JP', 'LastName': 'Martín-Martínez', 'Affiliation': 'Facultad Ciencias del Deporte. Universidad de Extremadura.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Calleja Gonzalez', 'Affiliation': 'Facultad de Educación y Deporte. Universidad del País Vasco (UPV/EHU).'}, {'ForeName': 'José Carmelo', 'Initials': 'JC', 'LastName': 'Adsuar Sala', 'Affiliation': 'Facultad Ciencias del Deporte. Universidad de Extremadura.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Gómez-Pomares', 'Affiliation': 'Facultad Ciencias del Deporte. Universidad de Extremadura.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Carlos-Vivas', 'Affiliation': 'Facultad Ciencias del Deporte. Universidad de Extremadura.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Pérez-Gómez', 'Affiliation': 'Facultad Ciencias del Deporte. Universidad de Extremadura.'}]",Nutricion hospitalaria,['10.20960/nh.03032']
2908,32960889,Bifidobacterium animalis subsp lactis HN019 presents antimicrobial potential against periodontopathogens and modulates the immunological response of oral mucosa in periodontitis patients.,"OBJECTIVE


To evaluate the effects of Bifidobacterium animalis subsp. lactis HN019 (HN019) on clinical periodontal parameters (plaque accumulation and gingival bleeding), on immunocompetence of gingival tissues [expression of beta-defensin (BD)-3, toll-like receptor 4 (TLR4), cluster of differentiation(CD)-57 and CD-4], and on immunological properties of saliva (IgA levels) in non-surgical periodontal therapy in generalized chronic periodontitis (GCP) patients. Adhesion to buccal epithelial cells (BEC) and the antimicrobial properties of HN019 were also investigated.
MATERIALS AND METHODS


Thirty patients were recruited and monitored clinically at baseline (before scaling and root planing-SRP) and after 30 and 90 days. Patients were randomly assigned to Test (SRP+Probiotic, n = 15) or Control (SRP+Placebo, n = 15) group. Probiotic lozenges were used for 30 days. Gingival tissues and saliva were immunologically analyzed. The adhesion of HN019 with or without Porphyromonas gingivalis in BEC and its antimicrobial properties were investigated in in vitro assays. Data were statistically analyzed (p<0.05).
RESULTS


Test group presented lower plaque index (30 days) and lower marginal gingival bleeding (90 days) when compared with Control group. Higher BD-3, TLR4 and CD-4 expressions were observed in gingival tissues in Test group than in Control group. HN019 reduced the adhesion of P. gingivalis to BEC and showed antimicrobial potential against periodontopathogens.
CONCLUSION


Immunological and antimicrobial properties of B. lactis HN019 make it a potential probiotic to be used in non-surgical periodontal therapy of patients with GCP.
CLINICAL RELEVANCE


B. lactis HN019 may be a potential probiotic to improve the effects of non-surgical periodontal therapy. Name of the registry and registration number (ClinicalTrials.gov): ""Effects of probiotic therapy in the treatment of periodontitis""-NCT03408548.",2020,"Higher BD-3, TLR4 and CD-4 expressions were observed in gingival tissues in Test group than in Control group.","['generalized chronic periodontitis (GCP) patients', 'periodontitis patients', 'patients with GCP', 'Thirty patients were recruited and monitored clinically at baseline (before scaling and root planing-SRP) and after 30 and 90 days']","['Bifidobacterium animalis subsp', 'probiotic therapy', 'Control (SRP+Placebo', 'Probiotic lozenges']","['marginal gingival bleeding', 'Higher BD-3, TLR4 and CD-4 expressions', 'clinical periodontal parameters (plaque accumulation and gingival bleeding), on immunocompetence of gingival tissues [expression of beta-defensin (BD)-3, toll-like receptor 4 (TLR4), cluster of differentiation(CD)-57 and CD-4], and on immunological properties of saliva (IgA levels', 'lower plaque index', 'adhesion of P. gingivalis to BEC', 'Gingival tissues and saliva']","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0266929', 'cui_str': 'Chronic periodontitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0085287', 'cui_str': 'Root planing of tooth'}, {'cui': 'C0074512', 'cui_str': 'SRP (Signal Recognition Particle)'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}, {'cui': 'C2242626', 'cui_str': 'Probiotic therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0991564', 'cui_str': 'Lozenge'}]","[{'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0017565', 'cui_str': 'Bleeding gums'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0887942', 'cui_str': 'beta-Defensins'}, {'cui': 'C1321919', 'cui_str': 'TLR4 protein, human'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0007589', 'cui_str': 'Differentiation, Cell'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0020987', 'cui_str': 'Immunologic competence'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0205470', 'cui_str': 'Immunologic'}, {'cui': 'C0871161', 'cui_str': 'Property'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0001511', 'cui_str': 'Adhesion'}, {'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C0014597', 'cui_str': 'Epithelial cell'}]",30.0,0.0273598,"Higher BD-3, TLR4 and CD-4 expressions were observed in gingival tissues in Test group than in Control group.","[{'ForeName': 'Marcos M', 'Initials': 'MM', 'LastName': 'Invernici', 'Affiliation': 'Department of Oral and Maxillofacial Surgery and Periodontology, School of Dentistry of Ribeirão Preto, University of São Paulo - USP, Ribeirão Preto, São Paulo, Brazil.'}, {'ForeName': 'Flávia A C', 'Initials': 'FAC', 'LastName': 'Furlaneto', 'Affiliation': 'Department of Oral and Maxillofacial Surgery and Periodontology, School of Dentistry of Ribeirão Preto, University of São Paulo - USP, Ribeirão Preto, São Paulo, Brazil.'}, {'ForeName': 'Sérgio L', 'Initials': 'SL', 'LastName': 'Salvador', 'Affiliation': 'Department of Clinical Analyses, School of Pharmaceutical Sciences of Ribeirão Preto, University of São Paulo - USP, Ribeirão Preto, São Paulo, Brazil.'}, {'ForeName': 'Arthur C', 'Initials': 'AC', 'LastName': 'Ouwehand', 'Affiliation': 'Dupont, Nutrition and Health, Kantvik, Finland.'}, {'ForeName': 'Seppo', 'Initials': 'S', 'LastName': 'Salminen', 'Affiliation': 'Functional Foods Forum, University of Turku, Turku, Finland.'}, {'ForeName': 'Anastasia', 'Initials': 'A', 'LastName': 'Mantziari', 'Affiliation': 'Functional Foods Forum, University of Turku, Turku, Finland.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Vinderola', 'Affiliation': 'Instituto de Lactología Industrial (UNL-CONICET), National University of the Litoral, Santa Fe, Argentina.'}, {'ForeName': 'Edilson', 'Initials': 'E', 'LastName': 'Ervolino', 'Affiliation': 'Division of Histology, Department of Basic Sciences, Dental School of Araçatuba, São Paulo State University, São Paulo, Brazil.'}, {'ForeName': 'Sandro Isaías', 'Initials': 'SI', 'LastName': 'Santana', 'Affiliation': 'Department of Oral and Maxillofacial Surgery and Periodontology, School of Dentistry of Ribeirão Preto, University of São Paulo - USP, Ribeirão Preto, São Paulo, Brazil.'}, {'ForeName': 'Pedro Henrique Felix', 'Initials': 'PHF', 'LastName': 'Silva', 'Affiliation': 'Department of Oral and Maxillofacial Surgery and Periodontology, School of Dentistry of Ribeirão Preto, University of São Paulo - USP, Ribeirão Preto, São Paulo, Brazil.'}, {'ForeName': 'Michel R', 'Initials': 'MR', 'LastName': 'Messora', 'Affiliation': 'Department of Oral and Maxillofacial Surgery and Periodontology, School of Dentistry of Ribeirão Preto, University of São Paulo - USP, Ribeirão Preto, São Paulo, Brazil.'}]",PloS one,['10.1371/journal.pone.0238425']
2909,32961273,High-definition transcranial direct current stimulation facilitates emotional face processing in individuals with high autistic traits: A sham-controlled study.,"The deficit in emotional face processing is a critical impairment for individuals with high autistic traits. The temporalparietal junction(TPJ) is considered to be closely related to emotional face processing. The aim of this study was to examine the effect of highdefinition transcranial direct current stimulation (HD-tDCS) over the right temporal-parietal junction (rTPJ) on facial emotion processing of individuals with high autistic traits using eye-tracking technology. Twenty-nine participants with high autistic traits completed an eyetracking task (including happy, fearful and neutral faces) before and after five consecutive days of stimulation (anodal or sham). Results showed that anodal HD-tDCS significantly increased fixation time and fixation count in the mouth area, but this effect was not found after the sham stimulation. Moreover, this increased effect of mouth recognition with anodal rTPJ HD-tDCS was shown in both happy and fearful faces, but no remarkable difference was found in neutral faces. These findings suggest that right TPJ anodal HD-tDCS can facilitate emotional face processing in individuals with high autistic traits.",2020,"Results showed that anodal HD-tDCS significantly increased fixation time and fixation count in the mouth area, but this effect was not found after the sham stimulation.","['Twenty-nine participants with high autistic traits', 'individuals with high autistic traits', 'individuals with high autistic traits using eye-tracking technology', 'Individuals with High Autistic Traits']","['High-Definition Transcranial Direct Current Stimulation Facilitates Emotional Face Processing', 'TPJ anodal HD-tDCS', 'anodal HD-tDCS', 'highdefinition transcranial direct current stimulation (HD-tDCS', 'anodal rTPJ HD-tDCS', 'eyetracking task (including happy, fearful and neutral faces', 'right temporal-parietal junction (rTPJ']","['facial emotion processing', 'fixation time and fixation count', 'neutral faces']","[{'cui': 'C0450351', 'cui_str': '29'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0205144', 'cui_str': 'Junctional'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0442043', 'cui_str': 'Temporal'}, {'cui': 'C0442030', 'cui_str': 'Parietal'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0015726', 'cui_str': 'Fear'}]","[{'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439157', 'cui_str': 'counts'}]",29.0,0.0460479,"Results showed that anodal HD-tDCS significantly increased fixation time and fixation count in the mouth area, but this effect was not found after the sham stimulation.","[{'ForeName': 'Yuxi', 'Initials': 'Y', 'LastName': 'Qiao', 'Affiliation': 'Department of Medical Psychology, Chaohu Clinical Medical College, Anhui Medical University, Hefei 230032, China; Anhui Province Key Laboratory of Cognition and Neuropsychiatric Disorders, Hefei 230032, China; Collaborative Innovation Center for Neuropsychiatric Disorders and Mental Health, Anhui Medical University, Hefei 230032, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Hu', 'Affiliation': 'Department of Medical Psychology, Chaohu Clinical Medical College, Anhui Medical University, Hefei 230032, China; Anhui Province Key Laboratory of Cognition and Neuropsychiatric Disorders, Hefei 230032, China; Collaborative Innovation Center for Neuropsychiatric Disorders and Mental Health, Anhui Medical University, Hefei 230032, China.'}, {'ForeName': 'Rongrong', 'Initials': 'R', 'LastName': 'Xuan', 'Affiliation': 'Department of Medical Psychology, Chaohu Clinical Medical College, Anhui Medical University, Hefei 230032, China; Anhui Province Key Laboratory of Cognition and Neuropsychiatric Disorders, Hefei 230032, China; Collaborative Innovation Center for Neuropsychiatric Disorders and Mental Health, Anhui Medical University, Hefei 230032, China.'}, {'ForeName': 'Qianhui', 'Initials': 'Q', 'LastName': 'Guo', 'Affiliation': 'Department of Medical Psychology, Chaohu Clinical Medical College, Anhui Medical University, Hefei 230032, China; Anhui Province Key Laboratory of Cognition and Neuropsychiatric Disorders, Hefei 230032, China; Collaborative Innovation Center for Neuropsychiatric Disorders and Mental Health, Anhui Medical University, Hefei 230032, China.'}, {'ForeName': 'Yuqi', 'Initials': 'Y', 'LastName': 'Ge', 'Affiliation': 'Department of First Clinical Medical College, Anhui Medical University, Hefei 230032, China.'}, {'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of First Clinical Medical College, Anhui Medical University, Hefei 230032, China.'}, {'ForeName': 'Chunyan', 'Initials': 'C', 'LastName': 'Zhu', 'Affiliation': 'Department of Medical Psychology, Chaohu Clinical Medical College, Anhui Medical University, Hefei 230032, China; Anhui Province Key Laboratory of Cognition and Neuropsychiatric Disorders, Hefei 230032, China; Collaborative Innovation Center for Neuropsychiatric Disorders and Mental Health, Anhui Medical University, Hefei 230032, China.'}, {'ForeName': 'Gongjun', 'Initials': 'G', 'LastName': 'Ji', 'Affiliation': 'Department of Medical Psychology, Chaohu Clinical Medical College, Anhui Medical University, Hefei 230032, China; Anhui Province Key Laboratory of Cognition and Neuropsychiatric Disorders, Hefei 230032, China; Collaborative Innovation Center for Neuropsychiatric Disorders and Mental Health, Anhui Medical University, Hefei 230032, China.'}, {'ForeName': 'Fengqiong', 'Initials': 'F', 'LastName': 'Yu', 'Affiliation': 'Department of Medical Psychology, Chaohu Clinical Medical College, Anhui Medical University, Hefei 230032, China; Anhui Province Key Laboratory of Cognition and Neuropsychiatric Disorders, Hefei 230032, China; Collaborative Innovation Center for Neuropsychiatric Disorders and Mental Health, Anhui Medical University, Hefei 230032, China.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Department of Medical Psychology, Chaohu Clinical Medical College, Anhui Medical University, Hefei 230032, China; Department of Neurology, First Affiliated Hospital of Anhui Medical University, Hefei 230032, China; Anhui Province Key Laboratory of Cognition and Neuropsychiatric Disorders, Hefei 230032, China; Collaborative Innovation Center for Neuropsychiatric Disorders and Mental Health, Anhui Medical University, Hefei 230032, China. Electronic address: wangkai1964@126.com.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Medical Psychology, Chaohu Clinical Medical College, Anhui Medical University, Hefei 230032, China; Anhui Province Key Laboratory of Cognition and Neuropsychiatric Disorders, Hefei 230032, China; Collaborative Innovation Center for Neuropsychiatric Disorders and Mental Health, Anhui Medical University, Hefei 230032, China. Electronic address: zhanglei17236@aliyun.com.'}]",Neuroscience letters,['10.1016/j.neulet.2020.135396']
2910,32979646,Randomised controlled trial confirms benefit of enhanced recovery after surgery on length of stay in ovarian cancer: How low can we go?,,2020,,['ovarian cancer'],[],[],"[{'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}]",[],[],,0.150722,,"[{'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Bisch', 'Affiliation': 'Division of Gynecologic Oncology, Tom Baker Cancer Centre, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Gregg', 'Initials': 'G', 'LastName': 'Nelson', 'Affiliation': 'Division of Gynecologic Oncology, Tom Baker Cancer Centre, University of Calgary, Calgary, Alberta, Canada. Electronic address: gsnelson@ucalgary.ca.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.08.015']
2911,32979708,"The comparison of the effect of soybean and fish oil on supplementation on menopausal symptoms in postmenopausal women: A randomized, double-blind, placebo-controlled trial.","BACKGROUND


The effect of soybean and omega-3 fatty acid supplementation on menopausal symptoms in postmenopausal women was investigated.
MATERIALS AND METHODS


In a randomized, double-blind, placebo-controlled trial postmenopausal women were randomly given either soybean (Soygan 500 mg capsule; n = 60), or omega-3 fatty acids (Omega-rex 1000 mg soft gel; n = 60), or placebo (n = 60) daily for 12 weeks. The primary outcome was a change on the menopause rating scale score (MRS), while the secondary outcome was any adverse symptoms and effect was effect of soybean or omega-3 fatty acid supplements on the blood lipids and thyroid hormone.
RESULTS


Based on the results of post-hoc in terms of overall MRS score there was a significant difference between the control and Soygan (p < 0.001) and Omega-rex groups (p = 0.03); however, there was no significant difference between the two intervention groups (p = 0.86). Soygan and Omega-rex had no effects on the blood lipids and thyroid hormone.
CONCLUSION


Soygan and Omega-rex reduced the MRS score and improved menopausal symptoms in postmenopausal women.",2020,"Soygan and Omega-rex had no effects on the blood lipids and thyroid hormone.
","['controlled trial postmenopausal women', 'postmenopausal women']","['soybean and omega-3 fatty acid supplementation', 'Omega-rex 1000\xa0mg soft gel; n\xa0=\xa060), or placebo', 'soybean or omega-3 fatty acid supplements', 'placebo', 'soybean and fish oil on supplementation', 'soybean (Soygan 500\xa0mg capsule; n\xa0=\xa060), or omega-3 fatty acids ']","['MRS score and improved menopausal symptoms', 'blood lipids and thyroid hormone', 'overall MRS score', 'menopausal symptoms', 'menopause rating scale score (MRS']","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0037733', 'cui_str': 'Soya bean'}, {'cui': 'C0561929', 'cui_str': 'N-3 fatty acid supplementation'}, {'cui': 'C1719844', 'cui_str': 'Omega'}, {'cui': 'C0324505', 'cui_str': 'Rex cat breed'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0205358', 'cui_str': 'Soft'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}]","[{'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0236075', 'cui_str': 'Menopausal symptom'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0040135', 'cui_str': 'Thyroid hormone'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.663549,"Soygan and Omega-rex had no effects on the blood lipids and thyroid hormone.
","[{'ForeName': 'Bahareh', 'Initials': 'B', 'LastName': 'Purzand', 'Affiliation': 'School of Medicine, Iran University of Medical Sciences (IUMS), Tehran, Iran.'}, {'ForeName': 'Samaneh', 'Initials': 'S', 'LastName': 'Rokhgireh', 'Affiliation': 'Endometriosis Research Center, Iran University of Medical Sciences (IUMS), Tehran, Iran. Electronic address: s.rokhgireh@gmail.com.'}, {'ForeName': 'Mansoore', 'Initials': 'M', 'LastName': 'Shabani Zanjani', 'Affiliation': 'Department of Obstetrics & Gynecology, Iran University of Medical Sciences, Akbarabadi Teaching Hospital & National Association of Iranian Obstetricians & Gynecologists (NAIGO), Tehran, Iran.'}, {'ForeName': 'Nooshin', 'Initials': 'N', 'LastName': 'Eshraghi', 'Affiliation': 'Department of Obstetrics & Gynecology, Iran University of Medical Sciences, Akbarabadi Teaching Hospital & National Association of Iranian Obstetricians & Gynecologists (NAIGO), Tehran, Iran.'}, {'ForeName': 'Mahdiss', 'Initials': 'M', 'LastName': 'Mohamadianamiri', 'Affiliation': 'Department of Obstetrics & Gynecology, Iran University of Medical Sciences, Akbarabadi Teaching Hospital & National Association of Iranian Obstetricians & Gynecologists (NAIGO), Tehran, Iran.'}, {'ForeName': 'Arezoo', 'Initials': 'A', 'LastName': 'Esmailzadeh', 'Affiliation': 'Endometriosis Research Center, Iran University of Medical Sciences (IUMS), Tehran, Iran.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Alkatout', 'Affiliation': 'Department of Obstetrics and Gynecology, Kiel School of Gynaecological Endoscopy, University Hospital Schleswig Holstein, Campus Kiel, Arnold-Heller-Str. 3, Haus C, 24105, Kiel, Germany.'}, {'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Gitas', 'Affiliation': 'Department of Obstetrics and Gynecology, University Hospital of Schleswig Holstein, Luebeck, Germany.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Allahqoli', 'Affiliation': 'Endometriosis Research Center, Iran University of Medical Sciences (IUMS), Tehran, Iran.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101239']
2912,32979429,Long-term tDCS effects on neurophysiological measures of cognitive control in tobacco smokers.,"INTRODUCTION


In this study we assessed the effects of transcranial Direct Current Stimulation (tDCS) on inhibitory control and error processing as measures of cognitive control to better understand tDCS modulation of smoking behaviour.
METHODS


Smokers were allocated to six sessions of either active tDCS (n = 34) or sham tDCS (n = 35) (https://clinicaltrials.gov/ct2/show/NCT03027687). Immediately before, one day after, and three months after all tDCS sessions, participants performed the Go-NoGo task while we measured behavioural and neurophysiological responses.
RESULTS


One day after the intervention no significant effect was found of active tDCS on behavioural and neurophysiological measures of cognitive control in tobacco smokers. However, a significant improvement in reaction times, and a decrease in No-Go P3 amplitudes for smoking cues was found three months after active tDCS.
CONCLUSION


Given the direction of the effect, we speculate that tDCS has a long-term modulatory learning effect on selective attention and motor inhibition.",2020,One day after the intervention no significant effect was found of active tDCS on behavioural and neurophysiological measures of cognitive control in tobacco smokers.,"['tobacco smokers', 'Smokers']","['sham tDCS', 'transcranial Direct Current Stimulation (tDCS', 'tDCS', 'active tDCS']","['No-Go P3 amplitudes for smoking cues', 'reaction times', 'behavioural and neurophysiological measures of cognitive control']","[{'cui': 'C4505217', 'cui_str': 'Smokers, Tobacco'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",,0.0365492,One day after the intervention no significant effect was found of active tDCS on behavioural and neurophysiological measures of cognitive control in tobacco smokers.,"[{'ForeName': 'Ilse', 'Initials': 'I', 'LastName': 'Verveer', 'Affiliation': 'Department of Psychology, Education and Child Studies, Erasmus School of Social and Behavioural Sciences, Erasmus University, Rotterdam, the Netherlands. Electronic address: verveer@essb.eur.nl.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Remmerswaal', 'Affiliation': 'Department of Psychology, Education and Child Studies, Erasmus School of Social and Behavioural Sciences, Erasmus University, Rotterdam, the Netherlands.'}, {'ForeName': 'Frederik M', 'Initials': 'FM', 'LastName': 'van der Veen', 'Affiliation': 'Department of Psychology, Education and Child Studies, Erasmus School of Social and Behavioural Sciences, Erasmus University, Rotterdam, the Netherlands.'}, {'ForeName': 'Ingmar H A', 'Initials': 'IHA', 'LastName': 'Franken', 'Affiliation': 'Department of Psychology, Education and Child Studies, Erasmus School of Social and Behavioural Sciences, Erasmus University, Rotterdam, the Netherlands.'}]",Biological psychology,['10.1016/j.biopsycho.2020.107962']
2913,32965230,Development and Evaluation of a Tailored Mobile Health Intervention to Improve Medication Adherence in Black Patients With Uncontrolled Hypertension and Type 2 Diabetes: Pilot Randomized Feasibility Trial.,"BACKGROUND


Research has underscored the need to develop socioculturally tailored interventions to improve adherence behaviors in minority patients with hypertension (HTN) and type 2 diabetes (T2D). Novel mobile health (mHealth) approaches are potential methods for delivering tailored interventions to minority patients with increased cardiovascular risk.
OBJECTIVE


This study aims to develop and evaluate the acceptability and preliminary efficacy of a tailored mHealth adherence intervention versus attention control (AC) on medication adherence, systolic blood pressure (SBP), diastolic blood pressure (DBP), and hemoglobin A 1c  (HbA 1c ) at 3 months in 42 Black patients with uncontrolled HTN and/or T2D who were initially nonadherent to their medications.
METHODS


This was a two-phase pilot study consisting of a formative phase and a clinical efficacy phase. The formative phase consisted of qualitative interviews with 10 members of the target patient population (7/10, 70% female; mean age 65.8 years, SD 5.6) to tailor the intervention based on the Information-Motivation-Behavioral skills model of adherence. The clinical efficacy phase consisted of a 3-month pilot randomized controlled trial to evaluate the tailored mHealth intervention versus an AC. The tablet-delivered intervention included a tailoring survey, an individualized adherence profile, and a personalized list of interactive adherence-promoting modules, whereas AC included the tailoring survey and health education videos delivered on the tablet. Acceptability was assessed through semistructured exit interviews. Medication adherence was assessed using the 8-item Morisky Medication Adherence Scale, whereas blood pressure and HbA 1c  were assessed using automated devices.
RESULTS


In phase 1, thematic analysis of the semistructured interviews revealed the following 5 major barriers to adherence: disruptions in daily routine, forgetfulness, concerns about adverse effects, preference for natural remedies, and burdens of medication taking. Patients recommended the inclusion of modules that address improving patient-provider communication, peer vignettes, and stress reduction strategies to facilitate adherence. A total of 42 Black patients (23/42, 55% male; mean age 57.6 years, SD 11.1) participated in the clinical efficacy pilot trial. At 3 months, both groups showed significant improvements in adherence (mean 1.35, SD 1.60; P<.001) and SBP (-4.76 mm Hg; P=.04) with no between-group differences (P=.50 and P=.10). The decreases in DBP and HbA 1c  over time were nonsignificant (-1.97 mm Hg; P=.20; and -0.2%; P=.45, respectively). Patients reported high acceptability of the intervention for improving their adherence.
CONCLUSIONS


This pilot study demonstrated preliminary evidence on the acceptability of a tailored mHealth adherence intervention among a sample of Black patients with uncontrolled HTN and T2D who were initially nonadherent to their medications. Future research should explore whether repeated opportunities to use the mHealth intervention would result in improvements in behavioral and clinical outcomes over time. Modifications to the intervention as a result of the pilot study should guide future efforts.
TRIAL REGISTRATION


ClinicalTrials.gov NCT01643473; http://clinicaltrials.gov/ct2/show/ NCT01643473.",2020,The decreases in DBP and HbA 1c  over time were nonsignificant,"['minority patients with increased cardiovascular risk', '42 Black patients (23/42, 55% male; mean age 57.6 years, SD 11.1) participated in the clinical efficacy pilot trial', 'Black patients with uncontrolled HTN and T2D who were initially nonadherent to their medications', 'minority patients with hypertension (HTN) and type 2 diabetes (T2D', '10 members of the target patient population (7/10, 70% female; mean age 65.8 years, SD 5.6) to tailor the intervention based on the Information-Motivation-Behavioral skills model of adherence', '42 Black patients with uncontrolled HTN', 'Black Patients With Uncontrolled Hypertension and Type 2']","['tailored mHealth adherence intervention versus attention control (AC', 'tailored mHealth adherence intervention', 'Tailored Mobile Health Intervention', 'tailored mHealth intervention']","['adherence behaviors', 'medication adherence, systolic blood pressure (SBP), diastolic blood pressure (DBP), and hemoglobin A 1c  (HbA 1c ', 'Medication adherence', 'adverse effects, preference for natural remedies, and burdens of medication taking', '8-item Morisky Medication Adherence Scale', 'adherence', 'blood pressure and HbA 1c', 'DBP and HbA 1c  over time', 'Acceptability', 'Medication Adherence', 'SBP']","[{'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1868885', 'cui_str': 'Uncontrolled hypertension'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517794', 'cui_str': '5.6'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0516638', 'cui_str': 'Self-initiated health seeking behavior'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0920324', 'cui_str': 'Homeopathic medicine'}, {'cui': 'C1290952', 'cui_str': 'Taking medication'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",42.0,0.0574425,The decreases in DBP and HbA 1c  over time were nonsignificant,"[{'ForeName': 'Antoinette', 'Initials': 'A', 'LastName': 'Schoenthaler', 'Affiliation': 'Department of Population Health, NYU school of Medicine, Center for Healthful Behavior Change, NYU Langone Health, New York, NY, United States.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Leon', 'Affiliation': 'Department of Clinical Psychology, Fordham University, New York, NY, United States.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Butler', 'Affiliation': 'Center for Personalized Health, Feinstein Institutes for Medical Research, Northwell Health, Manhasset, NY, United States.'}, {'ForeName': 'Karsten', 'Initials': 'K', 'LastName': 'Steinhaeuser', 'Affiliation': 'Radiant Point Technologies, Inc., Honolulu, HI, United States.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Wardzinski', 'Affiliation': 'Radiant Point Technologies, Inc., Honolulu, HI, United States.'}]",JMIR mHealth and uHealth,['10.2196/17135']
2914,32965237,Telomerase Activation to Reverse Immunosenescence in Elderly Patients With Acute Coronary Syndrome: Protocol for a Randomized Pilot Trial.,"BACKGROUND


Inflammation plays a key role in the pathophysiology of coronary heart disease (CHD) and its acute manifestation, acute coronary syndrome (ACS). Aging is associated with a decline of the immune system, a process known as immunosenescence. This is characterized by an increase in highly proinflammatory T cells that are involved in CHD progression, plaque destabilization, and myocardial ischemia-reperfusion injury. Telomere dysfunction has been implicated in immunosenescence of T lymphocytes. Telomerase is the enzyme responsible for maintaining telomeres during cell divisions. It has a protective effect on cells under oxidative stress and helps regulate flow-mediated dilation in microvasculature.
OBJECTIVE


The TACTIC (Telomerase ACTivator to reverse Immunosenescence in Acute Coronary Syndrome) trial will investigate whether a telomerase activator, TA-65MD, can reduce the proportion of senescent T cells in patients with ACS with confirmed CHD. It will also assess the effect of TA-65MD on decreasing telomere shortening, reducing oxidative stress, and improving endothelial function.
METHODS


The study was designed as a single-center, randomized, double-blind, parallel-group, placebo-controlled phase II trial. Recruitment started in January 2019. A total of 90 patients, aged 65 years or older, with treated ACS who have had CHD confirmed by angiography will be enrolled. They will be randomized to one of two groups: TA-65MD oral therapy (8 mg twice daily) or placebo taken for 12 months. The primary outcome is the effect on immunosenescence determined by a decrease in the proportion of CD8+ TEMRA (T effector memory cells re-expressing CD45RA [CD45 expressing exon A]) cells at 12 months. Secondary outcomes include leukocyte telomere length, endothelial function, cardiac function as measured by echocardiography and NT-proBNP (N-terminal fragment of the prohormone brain-type natriuretic peptide), systemic inflammation, oxidative stress, and telomerase activity.
RESULTS


The study received National Health Service (NHS) ethics approval on August 9, 2018; Medicines and Healthcare products Regulatory Agency approval on October 19, 2018; and NHS Health Research Authority approval on October 22, 2018. The trial began recruiting participants in January 2019 and completed recruitment in March 2020; the trial is due to report results in 2021.
CONCLUSIONS


This pilot trial in older patients with CHD will explore outcomes not previously investigated outside in vitro or preclinical models. The robust design ensures that bias has been minimized. Should the results indicate reduced frequency of immunosenescent CD8+ T cells as well as improvements in telomere length and endothelial function, we will plan a larger, multicenter trial in patients to determine if TA-65MD is beneficial in the treatment of CHD in elderly patients.
TRIAL REGISTRATION


ISRCTN Registry ISRCTN16613292; http://www.isrctn.com/ISRCTN16613292 and European Union Drug Regulating Authorities Clinical Trials Database (EudraCT), European Union Clinical Trials Register 2017-002876-26; https://tinyurl.com/y4m2so8g.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/19456.",2020,The primary outcome is the effect on immunosenescence determined by a decrease in the proportion of CD8+ TEMRA (T effector memory cells re-expressing CD45RA [CD45 expressing exon A]) cells at 12 months.,"['older patients with CHD', 'Elderly Patients With Acute Coronary Syndrome', '90 patients, aged 65 years or older, with treated ACS who have had CHD confirmed by angiography will be enrolled', 'elderly patients', 'patients with ACS with confirmed CHD']","['placebo', 'TA-65MD', 'TA-65MD oral therapy']","['proportion of CD8+ TEMRA (T effector memory cells re-expressing CD45RA [CD45 expressing exon A]) cells', 'leukocyte telomere length, endothelial function, cardiac function as measured by echocardiography and NT-proBNP']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C4543203', 'cui_str': 'Effector'}, {'cui': 'C0312737', 'cui_str': 'Immunologic cell'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0108789', 'cui_str': 'Lymphocyte antigen CD45RA'}, {'cui': 'C0054961', 'cui_str': 'Lymphocyte antigen CD45'}, {'cui': 'C0015295', 'cui_str': 'Exons'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}]",90.0,0.503371,The primary outcome is the effect on immunosenescence determined by a decrease in the proportion of CD8+ TEMRA (T effector memory cells re-expressing CD45RA [CD45 expressing exon A]) cells at 12 months.,"[{'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Maier', 'Affiliation': 'Newcastle Clinical Trials Unit, Newcastle University, Newcastle Upon Tyne, United Kingdom.'}, {'ForeName': 'Bilal', 'Initials': 'B', 'LastName': 'Bawamia', 'Affiliation': 'James Cook University Hospital, Middlesbrough, United Kingdom.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Bennaceur', 'Affiliation': 'Institute of Genetic Medicine, Newcastle University, Newcastle Upon Tyne, United Kingdom.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Dunn', 'Affiliation': 'Newcastle Clinical Trials Unit, Newcastle University, Newcastle Upon Tyne, United Kingdom.'}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Marsay', 'Affiliation': 'Newcastle Clinical Trials Unit, Newcastle University, Newcastle Upon Tyne, United Kingdom.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Amoah', 'Affiliation': 'Institute of Genetic Medicine, Newcastle University, Newcastle Upon Tyne, United Kingdom.'}, {'ForeName': 'Adetayo', 'Initials': 'A', 'LastName': 'Kasim', 'Affiliation': 'Wolfson Research Institute for Health and Wellbeing, Durham University, Durham, United Kingdom.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Filby', 'Affiliation': 'Flow Cytometry Core Facility, Newcastle University, Newcastle Upon Tyne, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Austin', 'Affiliation': 'James Cook University Hospital, Middlesbrough, United Kingdom.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Hancock', 'Affiliation': 'Newcastle Clinical Trials Unit, Newcastle University, Newcastle Upon Tyne, United Kingdom.'}, {'ForeName': 'Ioakim', 'Initials': 'I', 'LastName': 'Spyridopoulos', 'Affiliation': 'Institute of Genetic Medicine, Newcastle University, Newcastle Upon Tyne, United Kingdom.'}]",JMIR research protocols,['10.2196/19456']
2915,32960998,"Performance, acceptability, and validation of a phone application bowel diary.","AIMS


To assess performance, acceptability, external validity, and reliability of a phone application electronic bowel diary (PFDN Bowel eDiary).
METHODS


Women reporting refractory accidental bowel leakage (ABL) were enrolled in a randomized, crossover trial evaluating paper versus eDiary documentation of bowel movements (BM) and fecal incontinence episodes (FIE). Events were characterized by the presence or absence of urgency and Bristol stool scale consistency. The eDiary entries were date/time stamped and prompted by twice-daily phone notifications. Women were randomized to complete up to three consecutive 14-day diaries in two sequences. Diary events were compared between formats using the Pearson correlation. System usability scale (SUS) assessed eDiary usability. The eDiary test-retest reliability was assessed with intraclass correlations (ICCs).
RESULTS


Paired diary data were available from 60/69 (87%) women 63.8 ± 9.8 years old with mean 13.2 BM per week and 6.5 FIE per week (nearly half with urgency). Among those providing diaries, adherence did not differ by paper or eDiary (93.3% vs. 95.0%). Notifications prompted 29.6% of eDiary entries, improving adherence from 70% to 95%. Paper and eDiaries were moderate to-strongly correlated for BMs per week (r = .61), urgency BMs per week (r = .76), FIE per week (r = .66), urgency FIE per week (r = .72). Test-retest reliability was good (ICC = .81 BMs per week, .79 urgency BMs per week, .74 FIE per week, and .62 urgency FIE per week). The mean SUS score was high, 82.3 ± 17.5 (range, 0-100) with 91.4% rating it easy to use, and 75.9% preferring the eDiary over paper.
CONCLUSION


The PFDN Bowel eDiary correlated well with paper diary was considered easy to use, preferred to paper diaries, had high rates of confirmed real-time diary completion that obviated staff data entry.",2020,Test-retest reliability was good,['Women reporting refractory accidental bowel leakage (ABL'],['phone application electronic bowel diary (PFDN Bowel eDiary'],"['Diary events', 'System usability scale (SUS) assessed eDiary usability', 'Performance, acceptability, and validation of a phone application bowel diary', 'urgency BMs per week ', 'performance, acceptability, external validity, and reliability', 'presence or absence of urgency and Bristol stool scale consistency', 'bowel movements (BM) and fecal incontinence episodes (FIE', 'mean SUS score', 'urgency FIE']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0000924', 'cui_str': 'Accident'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0015376', 'cui_str': 'Extravasation'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}]","[{'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0042283', 'cui_str': 'Validity (Epidemiology)'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",100.0,0.0331857,Test-retest reliability was good,"[{'ForeName': 'Halina M', 'Initials': 'HM', 'LastName': 'Zyczynski', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh/Magee-Womens Research Institute, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Holly E', 'Initials': 'HE', 'LastName': 'Richter', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Vivian W', 'Initials': 'VW', 'LastName': 'Sung', 'Affiliation': ""Department of Obstetrics and Gynecology, Warren Alpert Medical School of Brown University, Women's and Infants Hospital, Providence, Rhode Island, USA.""}, {'ForeName': 'Lily A', 'Initials': 'LA', 'LastName': 'Arya', 'Affiliation': 'Department of Obstetrics and Gynecology, Hospital of University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Emily S', 'Initials': 'ES', 'LastName': 'Lukacz', 'Affiliation': 'Department of Reproductive Medicine, UC San Diego Health Care System, San Diego, California, USA.'}, {'ForeName': 'Anthony G', 'Initials': 'AG', 'LastName': 'Visco', 'Affiliation': 'Department of Obstetrics and Gynecology, Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'David D', 'Initials': 'DD', 'LastName': 'Rahn', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Texas Southwestern, Dallas, Texas, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Carper', 'Affiliation': 'Biostatistics and Epidemiology Division, RTI International, Durham, NC, USA.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Mazloomdoost', 'Affiliation': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD, USA.'}, {'ForeName': 'Marie G', 'Initials': 'MG', 'LastName': 'Gantz', 'Affiliation': 'Biostatistics and Epidemiology Division, RTI International, Durham, NC, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Neurourology and urodynamics,['10.1002/nau.24520']
2916,32960999,"Which combination is most effective in women with idiopathic overactive bladder, including bladder training, biofeedback, and electrical stimulation? A prospective randomized controlled trial.","OBJECTIVE


To evaluate the efficacy of single and combined use of biofeedback (BF) and electrical stimulation (ES) added to bladder training (BT) on incontinence-related quality of life (QoL) and clinical parameters in women with idiopathic overactive bladder (OAB).
MATERIAL AND METHODS


Seventy women were randomized into four groups as follows: Group 1 received BT alone (n = 18), Group 2 received BT + BF (n = 17), Group 3 received BT + ES (n = 18), and Group 4 received BT + BF + ES (n = 17). BF and ES were performed 3 days a week, 20 min a day, a total of 24 sessions for 8 weeks. All women were evaluated in terms of incontinence severity (pad test), pelvic floor muscles strength (perineometer), 3-day voiding diary (frequency of voiding, nocturia, incontinence episodes, and number of pads), QoL (incontinence impact questionnaire), treatment success (positive response rate), cure/improvement rate, treatment satisfaction (Likert scale), and discomfort level (visual analog scale).
RESULTS


At the end of the treatment, severity of incontinence, frequency of voiding, incontinence episodes, and treatment satisfaction significantly improved in Group 3 and Group 4 compared with the other two groups. In Group 3 and Group 4, high statistically significant values were found in cure/improvement and positive response rates as opposed to Group 1 and Group 2. In Group 2 and Group 3, statistically significant improvements were seen in nocturia and QoL compared with Group 1. Moreover, statistically significant improvements in nocturia and QoL were found in Group 4 compared with the other three groups. There was no difference in the discomfort level of application between the groups.
CONCLUSION


We conclude that in the first-line conservative treatment of women with idiopathic OAB: (i) adding BF and/or ES to BT increases treatment effectiveness, (ii) clinical efficiency is greater when the combination includes ES, (iii) BT + BF + ES (triple combination) is the most effective treatment option in reducing nocturia and improving QoL.",2020,"In Group 3 and Group 4, high statistically significant values were found in cure/improvement and positive response rates as opposed to Group 1 and Group 2.","['women with idiopathic overactive bladder', 'women with idiopathic overactive bladder (OAB', 'women with idiopathic OAB', 'Seventy women were randomized into four groups as follows']","['biofeedback (BF) and electrical stimulation (ES) added to bladder training (BT', 'BT\xa0+\xa0BF', 'BT + BF + ES', 'BT alone', 'BT\xa0+\xa0ES']","['nocturia and QoL', 'severity of incontinence, frequency of voiding, incontinence episodes, and treatment satisfaction', 'nocturia and improving QoL', 'incontinence severity (pad test), pelvic floor muscles strength (perineometer), 3-day voiding diary (frequency of voiding, nocturia, incontinence episodes, and number of pads), QoL (incontinence impact questionnaire), treatment success (positive response rate), cure/improvement rate, treatment satisfaction (Likert scale), and discomfort level (visual analog scale', 'discomfort level of application', 'incontinence-related quality of life (QoL', 'cure/improvement and positive response rates']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0150474', 'cui_str': 'Urinary bladder training'}]","[{'cui': 'C0028734', 'cui_str': 'Nocturia'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0332568', 'cui_str': 'Pad'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0451267', 'cui_str': 'Likert scale'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}]",70.0,0.0805382,"In Group 3 and Group 4, high statistically significant values were found in cure/improvement and positive response rates as opposed to Group 1 and Group 2.","[{'ForeName': 'Sule', 'Initials': 'S', 'LastName': 'Firinci', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Faculty of Medicine, Pamukkale University, Denizli, Turkey.'}, {'ForeName': 'Necmettin', 'Initials': 'N', 'LastName': 'Yildiz', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Faculty of Medicine, Pamukkale University, Denizli, Turkey.'}, {'ForeName': 'Hakan', 'Initials': 'H', 'LastName': 'Alkan', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Faculty of Medicine, Pamukkale University, Denizli, Turkey.'}, {'ForeName': 'Zafer', 'Initials': 'Z', 'LastName': 'Aybek', 'Affiliation': 'Department of Urology, Faculty of Medicine, Pamukkale University, Denizli, Turkey.'}]",Neurourology and urodynamics,['10.1002/nau.24522']
2917,32961507,The effects of acute work stress and appraisal on psychobiological stress responses in a group office environment.,"BACKGROUND


The high prevalence of office stress and its detrimental health consequences are of concern to individuals, employers and society at large. Laboratory studies investigating office stress have mostly relied on data from participants that were tested individually on abstract tasks. In this study, we examined the effect of psychosocial office stress and work interruptions on the psychobiological stress response in a realistic but controlled group office environment. We also explored the role of cognitive stress appraisal as an underlying mechanism mediating the relationship between work stressors and the stress response.
METHODS AND MATERIALS


Ninety participants (44 female; mean age 23.11 ± 3.80) were randomly assigned to either a control condition or one of two experimental conditions in which they were exposed to psychosocial stress with or without prior work interruptions in a realistic multi-participant laboratory setting. To induce psychosocial stress, we adapted the Trier Social Stress Test for Groups to an office environment. Throughout the experiment, we continuously monitored heart rate and heart rate variability. Participants repeatedly reported on their current mood, calmness, wakefulness and perceived stress and gave saliva samples to assess changes in salivary cortisol and salivary alpha-amylase. Additionally, cognitive appraisal of the psychosocial stress test was evaluated.
RESULTS


Our analyses revealed significant group differences for most outcomes during or immediately after the stress test (i.e., mood, calmness, perceived stress, salivary cortisol, heart rate, heart rate variability) and during recovery (i.e., salivary cortisol and heart rate). Interestingly, the condition that experienced work interruptions showed a higher increase of cortisol levels but appraised the stress test as less threatening than individuals that experienced only psychosocial stress. Exploratory mediation analyses revealed a blunted response in subjective measures of stress, which was partially explained by the differences in threat appraisal.
DISCUSSION


The results showed that experimentally induced work stress led to significant responses of subjective measures of stress, the hypothalamic-pituitary-adrenal axis and the autonomic nervous system. However, there appears to be a discrepancy between the psychological and biological responses to preceding work interruptions. Appraising psychosocial stress as less threatening but still as challenging could be an adaptive way of coping and reflect a state of engagement and eustress.",2020,"Exploratory mediation analyses revealed a blunted response in subjective measures of stress, which was partially explained by the differences in threat appraisal.
",['Ninety participants (44 female; mean age 23.11 ± 3.80'],['control condition or one of two experimental conditions in which they were exposed to psychosocial stress with or without prior work interruptions in a realistic multi-participant laboratory setting'],"['heart rate and heart rate variability', 'stress test (i.e., mood, calmness, perceived stress, salivary cortisol, heart rate, heart rate variability) and during recovery (i.e., salivary cortisol and heart rate', 'psychobiological stress responses', 'psychobiological stress response', 'subjective measures of stress, the hypothalamic-pituitary-adrenal axis and the autonomic nervous system', 'cortisol levels', 'current mood, calmness, wakefulness and perceived stress and gave saliva samples', 'salivary cortisol and salivary alpha-amylase']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0020663', 'cui_str': 'Hypothalamic structure'}, {'cui': 'C0032022', 'cui_str': 'Pituitary-Adrenal System'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0043012', 'cui_str': 'Wakefulness'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C2350322', 'cui_str': 'Salivary alpha-Amylases'}]",90.0,0.0154888,"Exploratory mediation analyses revealed a blunted response in subjective measures of stress, which was partially explained by the differences in threat appraisal.
","[{'ForeName': 'Jasmine I', 'Initials': 'JI', 'LastName': 'Kerr', 'Affiliation': 'Mobiliar Lab for Analytics, Department of Management, Technology, and Economics, ETH Zurich, Weinbergstrasse 56/58, 8092 Zurich, Switzerland; Chair of Technology Marketing, Department of Management, Technology, and Economics, ETH Zurich, Weinbergstrasse 56/58, 8092 Zurich, Switzerland; Chair of Cognitive Science, Department of Humanities, Social and Political Sciences, ETH Zurich, Clausiusstrasse 59, 8092 Zurich, Switzerland. Electronic address: jkerr@ethz.ch.'}, {'ForeName': 'Mara', 'Initials': 'M', 'LastName': 'Naegelin', 'Affiliation': 'Mobiliar Lab for Analytics, Department of Management, Technology, and Economics, ETH Zurich, Weinbergstrasse 56/58, 8092 Zurich, Switzerland; Chair of Technology Marketing, Department of Management, Technology, and Economics, ETH Zurich, Weinbergstrasse 56/58, 8092 Zurich, Switzerland.'}, {'ForeName': 'Raphael P', 'Initials': 'RP', 'LastName': 'Weibel', 'Affiliation': 'Mobiliar Lab for Analytics, Department of Management, Technology, and Economics, ETH Zurich, Weinbergstrasse 56/58, 8092 Zurich, Switzerland; Chair of Technology Marketing, Department of Management, Technology, and Economics, ETH Zurich, Weinbergstrasse 56/58, 8092 Zurich, Switzerland.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Ferrario', 'Affiliation': 'Mobiliar Lab for Analytics, Department of Management, Technology, and Economics, ETH Zurich, Weinbergstrasse 56/58, 8092 Zurich, Switzerland; Chair of Technology Marketing, Department of Management, Technology, and Economics, ETH Zurich, Weinbergstrasse 56/58, 8092 Zurich, Switzerland.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'La Marca', 'Affiliation': 'Chair of Clinical Psychology and Psychotherapy, Department of Psychology, University of Zurich, Binzmuehlestrasse 14, 8050 Zurich, Switzerland; Clinica Holistica Engiadina, Plaz 40, 7542 Susch, Switzerland.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'von Wangenheim', 'Affiliation': 'Chair of Technology Marketing, Department of Management, Technology, and Economics, ETH Zurich, Weinbergstrasse 56/58, 8092 Zurich, Switzerland.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Hoelscher', 'Affiliation': 'Chair of Cognitive Science, Department of Humanities, Social and Political Sciences, ETH Zurich, Clausiusstrasse 59, 8092 Zurich, Switzerland.'}, {'ForeName': 'Victor R', 'Initials': 'VR', 'LastName': 'Schinazi', 'Affiliation': 'Chair of Cognitive Science, Department of Humanities, Social and Political Sciences, ETH Zurich, Clausiusstrasse 59, 8092 Zurich, Switzerland; Department of Psychology, Bond University, 14 University Drive, Robina Queensland 4226, Australia.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104837']
2918,32961514,The Effect of Intradermal Botulinum Toxin a injections on painful diabetic polyneuropathy.,"BACKGROUND AND AIMS


Botulinum toxin type A (BTX-A) have been recently administered to improve Diabetic neuropathies; however, the efficacy of this treatment for relieving pain in painful diabetic polyneuropathy (DPN) has not been studied yet. Herein, we investigated the efficacy of botulinum toxin A (BTX-A) on DPN.
METHODS


This prospective, randomized, double-blind, controlled trial was performed in Imam Hossein Medical Center, pain clinic (Tehran, Iran). Diabetic patients (141 cases), between 40 and 70 years old with polyneuropathy in lower limbs were randomly assigned to one of these three groups: 1. Group D1 received 150 units of BTX-A in one foot and normal saline 0.9% in the other foot, 2. Group D2 received BTX-A 150 units in both feet, 3. Group N received normal saline 0.9% in both feet. All injections were performed intradermally using insulin syringes in 20 different points of foot. Visual analogue scale (VAS) and neuropathy pain scale (NPS) were used to compare the groups.
RESULTS


The improvement of VAS, pain intensity, sharp and hot sensation, sensitive and unpleasant sensation, deep and surface sensation was significant when comparing BTX-A and placebo groups. However, dull and cold sensations improvement (p = 0.114, and p = 0.653; respectively) did not show a significant difference between BTX-A injection and placebo groups. Furthermore, the percentage of changes after treatment indicated that sharp pain was improved more than other complaints (80%, 81%, and 37% for D1, D2, and N groups; respectively).
CONCLUSION


Intradermal administration of BTX-A was effective in improving VAS and all of the items of NPS in patients with diabetic polyneuropathy, except for dull and cold sensation.",2020,"However, dull and cold sensations improvement (p = 0.114, and p = 0.653; respectively) did not show a significant difference between BTX-A injection and placebo groups.","['painful diabetic polyneuropathy', 'patients with diabetic polyneuropathy', 'Imam Hossein Medical Center, pain clinic (Tehran, Iran', 'painful diabetic polyneuropathy (DPN', 'Diabetic patients (141 cases), between 40 and 70 years old with polyneuropathy in lower limbs']","['Intradermal Botulinum Toxin a injections', 'BTX-A in one foot and normal saline', 'botulinum toxin A (BTX-A', 'BTX', 'placebo', 'normal saline', 'BTX-A']","['dull and cold sensations improvement', 'sharp pain', 'VAS, pain intensity, sharp and hot sensation, sensitive and unpleasant sensation, deep and surface sensation', 'Visual analogue scale (VAS) and neuropathy pain scale (NPS']","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0271680', 'cui_str': 'Diabetic polyneuropathy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521321', 'cui_str': 'Imam'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0242936', 'cui_str': 'Pain clinic'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0152025', 'cui_str': 'Polyneuropathy'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}]","[{'cui': 'C1522475', 'cui_str': 'Intradermal route'}, {'cui': 'C0006050', 'cui_str': 'Botulinum Toxin Type A'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0278144', 'cui_str': 'Dull pain'}, {'cui': 'C0234192', 'cui_str': 'Cold'}, {'cui': 'C0455270', 'cui_str': 'Sharp pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C1444775', 'cui_str': 'Sharp sensation quality'}, {'cui': 'C0444519', 'cui_str': 'Hot'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}]",,0.20487,"However, dull and cold sensations improvement (p = 0.114, and p = 0.653; respectively) did not show a significant difference between BTX-A injection and placebo groups.","[{'ForeName': 'Mehrdad', 'Initials': 'M', 'LastName': 'Taheri', 'Affiliation': 'Anesthesiology Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Meghdad', 'Initials': 'M', 'LastName': 'Sedaghat', 'Affiliation': 'Department of Internal Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Solhpour', 'Affiliation': 'Anesthesiology Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Pooya', 'Initials': 'P', 'LastName': 'Rostami', 'Affiliation': 'Anesthesiology Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Behnam', 'Initials': 'B', 'LastName': 'Safarpour Lima', 'Affiliation': 'Department of Neurology, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Electronic address: b.safarpour@sbmu.ac.ir.'}]",Diabetes & metabolic syndrome,['10.1016/j.dsx.2020.09.019']
2919,32961589,Recovery after enhanced versus conventional care laparoscopic hysterectomy performed in the afternoon: A randomized controlled trial.,"OBJECTIVE


To compare enhanced recovery after surgery (ERAS) and conventional care (CC) protocols on outcomes of laparoscopic hysterectomy (LH) performed in the afternoon.
METHODS


A single-center randomized controlled trial was conducted on 120 women undergoing LH who were randomly divided into the intervention group (IG; n=60) and control group (CG; n=60). Women in the IG were treated according to the ERAS protocol and those in the CG according to the CC protocol. The primary outcome was the length of hospitalization. Secondary outcomes were postoperative opioid use, postoperative pain and emesis, complications, operative bleeding, and time.
RESULTS


More women discharged during 24 hours in the IG than in the CG (88% vs 55%, P<0.001). The time to actual discharge (19 vs 22 hours, P<0.001) and ready-to-discharge time (15 vs 21 hours, P<0.001) were shorter and the use of oxycodone was lower (0 mg [0-0 vs 2.5 mg [0-10], P<0.001) in the IG than in the CG, respectively. Otherwise, no other significant differences between the groups were observed. The follow-up time was one month.
CONCLUSION


The ERAS protocol reduces hospital stay and decreases the use of opioids with no impairment in surgical outcome of LH. ClinicalTrials.gov: NCT03828981.",2020,"More women discharged during 24 hours in the IG than in the CG (88% vs 55%, P<0.001).",['120 women undergoing LH'],"['laparoscopic hysterectomy (LH', 'afternoon', 'surgery (ERAS) and conventional care (CC) protocols', 'conventional care laparoscopic hysterectomy', 'oxycodone']","['hospital stay', 'time to actual discharge', 'length of hospitalization', 'postoperative opioid use, postoperative pain and emesis, complications, operative bleeding, and time', 'ready-to-discharge time']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0404089', 'cui_str': 'Laparoscopic hysterectomy'}]","[{'cui': 'C0404089', 'cui_str': 'Laparoscopic hysterectomy'}, {'cui': 'C0439550', 'cui_str': 'Afternoon'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0030049', 'cui_str': 'Oxycodone'}]","[{'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C3267156', 'cui_str': 'Operative bleeding'}]",120.0,0.0997711,"More women discharged during 24 hours in the IG than in the CG (88% vs 55%, P<0.001).","[{'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Kilpiö', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Päivi S M', 'Initials': 'PSM', 'LastName': 'Härkki', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Maarit J', 'Initials': 'MJ', 'LastName': 'Mentula', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Antti', 'Initials': 'A', 'LastName': 'Väänänen', 'Affiliation': 'Department of Anesthesiology and Intensive Care, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Päivi I', 'Initials': 'PI', 'LastName': 'Pakarinen', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}]",International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics,['10.1002/ijgo.13382']
2920,32961895,A Quality Control System for Automated Prostate Segmentation on T2-Weighted MRI.,"Computer-aided detection and diagnosis (CAD) systems have the potential to improve robustness and efficiency compared to traditional radiological reading of magnetic resonance imaging (MRI). Fully automated segmentation of the prostate is a crucial step of CAD for prostate cancer, but visual inspection is still required to detect poorly segmented cases. The aim of this work was therefore to establish a fully automated quality control (QC) system for prostate segmentation based on T2-weighted MRI. Four different deep learning-based segmentation methods were used to segment the prostate for 585 patients. First order, shape and textural radiomics features were extracted from the segmented prostate masks. A reference quality score (QS) was calculated for each automated segmentation in comparison to a manual segmentation. A least absolute shrinkage and selection operator (LASSO) was trained and optimized on a randomly assigned training dataset (N = 1756, 439 cases from each segmentation method) to build a generalizable linear regression model based on the radiomics features that best estimated the reference QS. Subsequently, the model was used to estimate the QSs for an independent testing dataset (N = 584, 146 cases from each segmentation method). The mean ± standard deviation absolute error between the estimated and reference QSs was 5.47 ± 6.33 on a scale from 0 to 100. In addition, we found a strong correlation between the estimated and reference QSs (rho = 0.70). In conclusion, we developed an automated QC system that may be helpful for evaluating the quality of automated prostate segmentations.",2020,Computer-aided detection and diagnosis (CAD) systems have the potential to improve robustness and efficiency compared to traditional radiological reading of magnetic resonance imaging (MRI).,[],['Computer-aided detection and diagnosis (CAD) systems'],"['mean ± standard deviation absolute error', 'reference quality score (QS']",[],"[{'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",1756.0,0.0220048,Computer-aided detection and diagnosis (CAD) systems have the potential to improve robustness and efficiency compared to traditional radiological reading of magnetic resonance imaging (MRI).,"[{'ForeName': 'Mohammed R S', 'Initials': 'MRS', 'LastName': 'Sunoqrot', 'Affiliation': 'Department of Circulation and Medical Imaging, NTNU-Norwegian University of Science and Technology, 7030 Trondheim, Norway.'}, {'ForeName': 'Kirsten M', 'Initials': 'KM', 'LastName': 'Selnæs', 'Affiliation': 'Department of Circulation and Medical Imaging, NTNU-Norwegian University of Science and Technology, 7030 Trondheim, Norway.'}, {'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Sandsmark', 'Affiliation': 'Department of Radiology and Nuclear Medicine, St. Olavs Hospital, Trondheim University Hospital, 7030 Trondheim, Norway.'}, {'ForeName': 'Gabriel A', 'Initials': 'GA', 'LastName': 'Nketiah', 'Affiliation': 'Department of Circulation and Medical Imaging, NTNU-Norwegian University of Science and Technology, 7030 Trondheim, Norway.'}, {'ForeName': 'Olmo', 'Initials': 'O', 'LastName': 'Zavala-Romero', 'Affiliation': 'Department of Radiation Oncology, University of Miami Miller School of Medicine, Miami, FL 33136, USA.'}, {'ForeName': 'Radka', 'Initials': 'R', 'LastName': 'Stoyanova', 'Affiliation': 'Department of Radiation Oncology, University of Miami Miller School of Medicine, Miami, FL 33136, USA.'}, {'ForeName': 'Tone F', 'Initials': 'TF', 'LastName': 'Bathen', 'Affiliation': 'Department of Circulation and Medical Imaging, NTNU-Norwegian University of Science and Technology, 7030 Trondheim, Norway.'}, {'ForeName': 'Mattijs', 'Initials': 'M', 'LastName': 'Elschot', 'Affiliation': 'Department of Circulation and Medical Imaging, NTNU-Norwegian University of Science and Technology, 7030 Trondheim, Norway.'}]","Diagnostics (Basel, Switzerland)",['10.3390/diagnostics10090714']
2921,32962031,"Perspectives and Impact of a Parent-Child Intervention on Dietary Intake and Physical Activity Behaviours, Parental Motivation, and Parental Body Composition: A Randomized Controlled Trial.","Adults and children in Canada are not meeting physical activity guidelines nor consuming sufficient nutrient-rich foods. High engagement in these unhealthy behaviours can lead to obesity and its associated diseases. Parent-child interventions aimed at obesity prevention/treatment have assisted families with making positive changes to their nutrition and physical activity behaviours. Given that the home environment shapes early health behaviours, it is important to target both parents and children when addressing diet and physical activity. One method that has been shown to improve health outcomes is co-active coaching. The current study explored the impact of a three-month co-active coaching and/or health education intervention on the dietary intake and physical activity behaviours of parents with overweight/obesity and their children (ages 2.5-10; of any weight). Body composition (i.e., body mass index [BMI] and waist circumference), changes in parental motivation with respect to physical activity and dietary behaviours, and parental perceptions of program improvements were collected. A concurrent mixed methods study comprised of a randomized controlled trial and a descriptive qualitative design was utilized. Fifty parent-child dyads were recruited and randomly assigned to the control ( n  = 25) or intervention ( n  = 25) group. Assessments were completed at baseline, mid-intervention (six weeks), post-intervention (three months), and six-month follow-up. A linear mixed effects model was utilized for quantitative analysis. Inductive content analysis was used to extract themes from parent interviews. No significant results were observed over time for the dependent measures. Parents in both control and intervention groups reported varied program experiences, including developing changes in perspective, increased awareness of habits, and heightened accountability for making positive changes in themselves, and consequently, their families. Parents also shared barriers they faced when implementing changes (e.g., time, weather, stress). Qualitatively, both groups reported benefitting from this program, with the intervention group describing salient benefits from engaging in coaching. This research expands on the utility of coaching as a method for behaviour change, when compared to education only, in parents with overweight/obesity and their children.",2020,"Parents in both control and intervention groups reported varied program experiences, including developing changes in perspective, increased awareness of habits, and heightened accountability for making positive changes in themselves, and consequently, their families.","['parents with overweight/obesity and their children (ages 2.5-10; of any weight', 'Fifty parent-child dyads', 'parents with overweight/obesity and their children', 'Adults and children in Canada']","['Parent-Child Intervention', 'three-month co-active coaching and/or health education intervention']","['health outcomes', 'Body composition (i.e., body mass index', 'BMI] and waist circumference), changes in parental motivation with respect to physical activity and dietary behaviours, and parental perceptions of program improvements', 'Dietary Intake and Physical Activity Behaviours, Parental Motivation, and Parental Body Composition', 'dietary intake and physical activity behaviours']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0006823', 'cui_str': 'Canada'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4082119', 'cui_str': 'Three months'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0679133', 'cui_str': 'Respect'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}]",,0.031059,"Parents in both control and intervention groups reported varied program experiences, including developing changes in perspective, increased awareness of habits, and heightened accountability for making positive changes in themselves, and consequently, their families.","[{'ForeName': 'Shazya', 'Initials': 'S', 'LastName': 'Karmali', 'Affiliation': 'Health & Rehabilitation Sciences, Western University, London, ON N6A 3K7, Canada.'}, {'ForeName': 'Danielle S', 'Initials': 'DS', 'LastName': 'Battram', 'Affiliation': 'Food and Nutritional Sciences, Western University, Brescia University College, London, ON N6G 1H2, Canada.'}, {'ForeName': 'Shauna M', 'Initials': 'SM', 'LastName': 'Burke', 'Affiliation': 'School of Health Studies, Western University, London, ON N6A 3K7, Canada.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Cramp', 'Affiliation': 'Middlesex London Health Unit, London, ON N6A 3N7, Canada.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Johnson', 'Affiliation': 'Health & Rehabilitation Sciences, Western University, London, ON N6A 3K7, Canada.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Mantler', 'Affiliation': 'School of Health Studies, Western University, London, ON N6A 3K7, Canada.'}, {'ForeName': 'Don', 'Initials': 'D', 'LastName': 'Morrow', 'Affiliation': 'Health & Rehabilitation Sciences, Western University, London, ON N6A 3K7, Canada.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Ng', 'Affiliation': 'Department of Programs and Practice Support, College of Family Physicians of Canada, Mississauga, ON L4W 5A4, Canada.'}, {'ForeName': 'Erin S', 'Initials': 'ES', 'LastName': 'Pearson', 'Affiliation': 'School of Kinesiology, Faculty of Health and Behavioural Sciences, Lakehead University, Thunder Bay, ON P7B 5E1, Canada.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Petrella', 'Affiliation': 'Department of Family Practice, Faculty of Medicine, University of British Columbia, Vancouver, BC V6T 1Z3, Canada.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Tucker', 'Affiliation': 'School of Occupational Therapy, Western University, London, ON N6A 3K7, Canada.'}, {'ForeName': 'Jennifer D', 'Initials': 'JD', 'LastName': 'Irwin', 'Affiliation': 'Health & Rehabilitation Sciences, Western University, London, ON N6A 3K7, Canada.'}]",International journal of environmental research and public health,['10.3390/ijerph17186822']
2922,32969563,Cabozantinib plus docetaxel and prednisone in metastatic castration-resistant prostate cancer.,"OBJECTIVE


To evaluate the safety and efficacy of cabozantinib combined with docetaxel.
PATIENTS AND METHODS


This was a phase 1/2 multicentre study in patients with metastatic castration-resistant prostate cancer (mCRPC). Docetaxel (75 mg/m 2  every 3 weeks with daily prednisone 10 mg) was combined with escalating doses of daily cabozantinib (20, 40 and 60 mg). Based on the results of the phase 1 study, the investigation was expanded into a randomized study of docetaxel with prednisone (hereafter 'docetaxel/prednisone') plus the maximum tolerated dose (MTD) of cabozantinib compared with docetaxel/prednisone alone.
RESULTS


A total of 44 men with mCRPC were enrolled in this phase 1/2 trial. An MTD of 40 mg cabozantinib plus docetaxel/prednisone was determined. Dose-limiting toxicities were neutropenic fever and palmar-plantar erythrodysesthesia, and there was one death attributable to a thromboembolic event. In addition, grade 3 or 4 myelosuppression, hypophosphataemia and neuropathy were seen in three or more patients. In the phase 1 study, the median time to progression (TTP) and overall survival (OS) time were 13.6 and 16.3 months, respectively. In the phase 2 study, which was terminated early because of poor accrual, the median TTP and OS favoured the combination (n = 13) compared to docetaxel/prednisone alone (n = 12; 21.0 vs 6.6 months; P = 0.035 and 23.8 vs 15.6 months; P = 0.072, respectively).
CONCLUSION


Despite the limited number of patients in this study, preliminary data suggest that cabozantinib can be safely added to docetaxel/prednisone with possible enhanced efficacy.",2020,Dose limiting toxicities were neutropenic fever and palmer-plantar erythrodysesthesia and there was 1 death due to a thromboembolic event.,"['Metastatic Castrate Resistant Prostate Cancer', 'patients with mCRPC', '44 men with mCRPC']","['cabozantinib vs. docetaxel/prednisone', 'Cabozantinib plus Docetaxel and Prednisone', 'cabozantinib combined with docetaxel', 'docetaxel', 'Docetaxel', 'docetaxel/prednisone']","['median time to progression (TTP) and overall survival', 'median TTP and overall survival', 'neutropenic fever and palmer-plantar erythrodysesthesia', 'safety and efficacy', 'grade 3 or 4 myelosuppression, hypophosphatemia, and neuropathy']","[{'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C1328504', 'cui_str': 'Hormone refractory prostate cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C3181682', 'cui_str': 'cabozantinib'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0230373', 'cui_str': 'Palm of hand (surface region)'}, {'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0854467', 'cui_str': 'Myelosuppression'}, {'cui': 'C0085682', 'cui_str': 'Hypophosphatemia'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy'}]",44.0,0.0319574,Dose limiting toxicities were neutropenic fever and palmer-plantar erythrodysesthesia and there was 1 death due to a thromboembolic event.,"[{'ForeName': 'Ravi A', 'Initials': 'RA', 'LastName': 'Madan', 'Affiliation': 'Genitourinary Malignancies Branch, NCI, Bethesda, MD, USA.'}, {'ForeName': 'Fatima H', 'Initials': 'FH', 'LastName': 'Karzai', 'Affiliation': 'Genitourinary Malignancies Branch, NCI, Bethesda, MD, USA.'}, {'ForeName': 'Munjid', 'Initials': 'M', 'LastName': 'Al Harthy', 'Affiliation': 'Genitourinary Malignancies Branch, NCI, Bethesda, MD, USA.'}, {'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Petrylak', 'Affiliation': 'Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Joseph W', 'Initials': 'JW', 'LastName': 'Kim', 'Affiliation': 'Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Philip M', 'Initials': 'PM', 'LastName': 'Arlen', 'Affiliation': 'Genitourinary Malignancies Branch, NCI, Bethesda, MD, USA.'}, {'ForeName': 'Inger', 'Initials': 'I', 'LastName': 'Rosner', 'Affiliation': 'Center for Prostate Disease Research, Walter Reed National Military Medical Center, Bethesda, MD, USA.'}, {'ForeName': 'Marc R', 'Initials': 'MR', 'LastName': 'Theoret', 'Affiliation': 'Genitourinary Malignancies Branch, NCI, Bethesda, MD, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Cordes', 'Affiliation': 'Genitourinary Malignancies Branch, NCI, Bethesda, MD, USA.'}, {'ForeName': 'Marijo', 'Initials': 'M', 'LastName': 'Bilusic', 'Affiliation': 'Genitourinary Malignancies Branch, NCI, Bethesda, MD, USA.'}, {'ForeName': 'Cody J', 'Initials': 'CJ', 'LastName': 'Peer', 'Affiliation': 'Genitourinary Malignancies Branch, NCI, Bethesda, MD, USA.'}, {'ForeName': 'Nancy A', 'Initials': 'NA', 'LastName': 'Dawson', 'Affiliation': 'Georgetown Lombardi Comprehensive Cancer Center, Washington, DC, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Couvillon', 'Affiliation': 'Genitourinary Malignancies Branch, NCI, Bethesda, MD, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Hankin', 'Affiliation': 'Genitourinary Malignancies Branch, NCI, Bethesda, MD, USA.'}, {'ForeName': 'Moniquea', 'Initials': 'M', 'LastName': 'Williams', 'Affiliation': 'Genitourinary Malignancies Branch, NCI, Bethesda, MD, USA.'}, {'ForeName': 'Guin', 'Initials': 'G', 'LastName': 'Chun', 'Affiliation': 'Genitourinary Malignancies Branch, NCI, Bethesda, MD, USA.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Owens', 'Affiliation': 'Genitourinary Malignancies Branch, NCI, Bethesda, MD, USA.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Marte', 'Affiliation': 'Genitourinary Malignancies Branch, NCI, Bethesda, MD, USA.'}, {'ForeName': 'Min-Jung', 'Initials': 'MJ', 'LastName': 'Lee', 'Affiliation': 'Developmental Therapeutics Branch, NCI, Bethesda, MD, USA.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Tomita', 'Affiliation': 'Developmental Therapeutics Branch, NCI, Bethesda, MD, USA.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Yuno', 'Affiliation': 'Developmental Therapeutics Branch, NCI, Bethesda, MD, USA.'}, {'ForeName': 'Jane B', 'Initials': 'JB', 'LastName': 'Trepel', 'Affiliation': 'Genitourinary Malignancies Branch, NCI, Bethesda, MD, USA.'}, {'ForeName': 'Sunmin', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Developmental Therapeutics Branch, NCI, Bethesda, MD, USA.'}, {'ForeName': 'Seth M', 'Initials': 'SM', 'LastName': 'Steinberg', 'Affiliation': 'Biostatistics and Data Management Section, Center for Cancer Research, NCI, Bethesda, MD, USA.'}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Gulley', 'Affiliation': 'Genitourinary Malignancies Branch, NCI, Bethesda, MD, USA.'}, {'ForeName': 'William D', 'Initials': 'WD', 'LastName': 'Figg', 'Affiliation': 'Genitourinary Malignancies Branch, NCI, Bethesda, MD, USA.'}, {'ForeName': 'William L', 'Initials': 'WL', 'LastName': 'Dahut', 'Affiliation': 'Genitourinary Malignancies Branch, NCI, Bethesda, MD, USA.'}]",BJU international,['10.1111/bju.15227']
2923,32969833,An Internet-Based Intervention Augmented With a Diet and Physical Activity Consultation to Decrease the Risk of Dementia in At-Risk Adults in a Primary Care Setting: Pragmatic Randomized Controlled Trial.,"BACKGROUND


There is a need to develop interventions to reduce the risk of dementia in the community by addressing lifestyle factors and chronic diseases over the adult life course.
OBJECTIVE


This study aims to evaluate a multidomain dementia risk reduction intervention, Body Brain Life in General Practice (BBL-GP), targeting at-risk adults in primary care.
METHODS


A pragmatic, parallel, three-arm randomized trial involving 125 adults aged 18 years or older (86/125, 68.8% female) with a BMI of ≥25 kg/m 2  or a chronic health condition recruited from general practices was conducted. The arms included (1) BBL-GP, a web-based intervention augmented with an in-person diet and physical activity consultation; (2) a single clinician-led group, Lifestyle Modification Program (LMP); and (3) a web-based control. The primary outcome was the Australian National University Alzheimer Disease Risk Index Short Form (ANU-ADRI-SF).
RESULTS


Baseline assessments were conducted on 128 participants. A total of 125 participants were randomized to 3 groups (BBL-GP=42, LMP=41, and control=42). At immediate, week 18, week 36, and week 62 follow-ups, the completion rates were 43% (18/42), 57% (24/42), 48% (20/42), and 48% (20/42), respectively, for the BBL-GP group; 71% (29/41), 68% (28/41), 68% (28/41), and 51% (21/41), respectively, for the LMP group; and 62% (26/42), 69% (29/42), 60% (25/42), and 60% (25/42), respectively, for the control group. The primary outcome of the ANU-ADRI-SF score was lower for the BBL-GP group than the control group at all follow-ups. These comparisons were all significant at the 5% level for estimates adjusted for baseline differences (immediate: difference in means -3.86, 95% CI -6.81 to -0.90, P=.01; week 18: difference in means -4.05, 95% CI -6.81 to -1.28, P<.001; week 36: difference in means -4.99, 95% CI -8.04 to -1.94, P<.001; and week 62: difference in means -4.62, 95% CI -7.62 to -1.62, P<.001).
CONCLUSIONS


A web-based multidomain dementia risk reduction program augmented with allied health consultations administered within the general practice context can reduce dementia risk exposure for at least 15 months. This study was limited by a small sample size, and replication on a larger sample with longer follow-up will strengthen the results.
TRIAL REGISTRATION


Australian clinical trials registration number (ACTRN): 12616000868482; https://anzctr.org.au/ACTRN12616000868482.aspx.",2020,The primary outcome of the ANU-ADRI-SF score was lower for the BBL-GP group than the control group at all follow-ups.,"['125 participants', 'risk adults in primary care', '128 participants', '125 adults aged 18 years or older (86/125, 68.8% female) with a BMI of ≥25 kg/m 2  or a chronic health condition recruited from general practices was conducted']","['Internet-Based Intervention Augmented With a Diet and Physical Activity Consultation', 'multidomain dementia risk reduction intervention, Body Brain Life', 'BBL-GP, a web-based intervention augmented with an in-person diet and physical activity consultation; (2) a single clinician-led group, Lifestyle Modification Program (LMP); and (3) a web-based control']","['Risk of Dementia', 'ANU-ADRI-SF score', 'Australian National University Alzheimer Disease Risk Index Short Form (ANU-ADRI-SF', 'completion rates', 'dementia risk exposure']","[{'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C3898714', 'cui_str': 'Internet Intervention'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]",125.0,0.168262,The primary outcome of the ANU-ADRI-SF score was lower for the BBL-GP group than the control group at all follow-ups.,"[{'ForeName': 'Kaarin J', 'Initials': 'KJ', 'LastName': 'Anstey', 'Affiliation': 'School of Psychology, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Cherbuin', 'Affiliation': 'Centre for Research on Ageing, Health and Wellbeing, Australian National University, Canberra, Australia.'}, {'ForeName': 'Sarang', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Wicking Dementia Resaerch & Education Centre, University of Tasmania, Hobart, Australia.'}, {'ForeName': 'Mitchell', 'Initials': 'M', 'LastName': 'McMaster', 'Affiliation': 'Centre for Research on Ageing, Health and Wellbeing, Australian National University, Canberra, Australia.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': ""D'Este"", 'Affiliation': 'National Centre for Epidemiology and Public Health, Australian National University, Canberra, Australia.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Lautenschlager', 'Affiliation': 'Academic Unit for Psychiatry of Old Age, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Rebok', 'Affiliation': 'Johns Hopkins Centre on Aging and Health, Johns Hopkins University, Baltimore, MD, United States.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'McRae', 'Affiliation': 'Centre for Research on Ageing, Health and Wellbeing, Australian National University, Canberra, Australia.'}, {'ForeName': 'Susan J', 'Initials': 'SJ', 'LastName': 'Torres', 'Affiliation': 'Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Sciences, Deakin University, Melbourne, Australia.'}, {'ForeName': 'Kay L', 'Initials': 'KL', 'LastName': 'Cox', 'Affiliation': 'Medical School, University of Western Australia, Perth, Australia.'}, {'ForeName': 'Constance Dimity', 'Initials': 'CD', 'LastName': 'Pond', 'Affiliation': 'Department of General Practice, University of Newcastle, Newcastle, Australia.'}]",Journal of medical Internet research,['10.2196/19431']
2924,32969834,Virtual Reality Meditation Among Youth Experiencing Homelessness: Pilot Randomized Controlled Trial of Feasibility.,"BACKGROUND


Homelessness among youth is devastating, with high rates of substance use disorders and mental health comorbidity. Mindfulness-based interventions that include meditation and mindfulness skills training reduce stress and symptoms of anxiety or depression. However, engaging high-risk youth in interventions is challenging. Virtual reality is a more flexible platform for delivering meditation and may be appealing to youth.
OBJECTIVE


The study objectives were to evaluate the feasibility of delivering virtual reality meditation and of collecting outcome measures, including anxiety and physiologic stress.
METHODS


A sample of 30 youth experiencing homelessness was enrolled in the study. Youth were randomized to receive 10 minutes of one of three interventions: (1) virtual reality meditation, (2) audio meditation (through a web-based platform), or (3) virtual reality imagery of historical pictures and text. Subjects who consented to the study attended two research visits. The first visit collected survey measures of demographics, mental health, and substance use, and oriented subjects to the intervention platforms. The second visit (1-3 days later) delivered the intervention and collected pre and post outcome measures of anxiety and physiologic stress (salivary cortisol). Changes in anxiety and cortisol at the second visit were compared across groups using a linear regression model in which the primary analysis compared virtual reality meditation to audio meditation and secondary analyses compared virtual reality meditation to virtual reality imagery.
RESULTS


Anxiety scores decreased in all groups, with a larger reduction among the virtual reality meditation group (difference=10.8) compared to the web-based meditation or virtual reality images groups (difference=5.8 and 5.0, respectively). After controlling for baseline values, there were no significant group differences in changes in anxiety scores or cortisol levels. In comparing virtual reality meditation and audio meditation, the effect size for anxiety was moderate (Cohen d=0.58) while the effect size for cortisol was small (Cohen d=0.08).
CONCLUSIONS


Preliminary results suggest that virtual reality meditation has a moderate benefit for anxiety but not physiologic stress. Future research is needed to confirm these results in a larger sample and to investigate whether the effects are sustained or increase with repeated use of virtual reality mediation. Virtual reality meditation appears feasible to deliver among homeless youth and merits further study.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04004520; https://clinicaltrials.gov/ct2/show/NCT04004520.",2020,"RESULTS


Anxiety scores decreased in all groups, with a larger reduction among the virtual reality meditation group (difference=10.8) compared to the web-based meditation or virtual reality images groups (difference=5.8 and 5.0, respectively).","['Subjects who consented to the study attended two research visits', 'Youth Experiencing Homelessness', '30 youth experiencing homelessness was enrolled in the study', 'homeless youth']","['virtual reality meditation', 'virtual reality meditation to audio meditation and secondary analyses compared virtual reality meditation to virtual reality imagery', 'virtual reality meditation, (2) audio meditation (through a web-based platform), or (3) virtual reality imagery of historical pictures and text', 'Mindfulness-based interventions that include meditation and mindfulness skills training', 'Virtual Reality Meditation', 'Virtual reality meditation', 'virtual reality meditation and audio meditation']","['Anxiety scores', 'anxiety and physiologic stress', 'anxiety and physiologic stress (salivary cortisol', 'anxiety scores or cortisol levels', 'stress and symptoms of anxiety or depression']","[{'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0237154', 'cui_str': 'Homeless'}, {'cui': 'C0242663', 'cui_str': 'Homeless Children'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",30.0,0.0776992,"RESULTS


Anxiety scores decreased in all groups, with a larger reduction among the virtual reality meditation group (difference=10.8) compared to the web-based meditation or virtual reality images groups (difference=5.8 and 5.0, respectively).","[{'ForeName': 'Laura Johnson', 'Initials': 'LJ', 'LastName': 'Chavez', 'Affiliation': ""Nationwide Children's Hospital, Columbus, OH, United States.""}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Kelleher', 'Affiliation': ""Nationwide Children's Hospital, Columbus, OH, United States.""}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Slesnick', 'Affiliation': 'Department of Human Sciences, The Ohio State University, Columbus, OH, United States.'}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Holowacz', 'Affiliation': 'Department of Human Sciences, The Ohio State University, Columbus, OH, United States.'}, {'ForeName': 'Ellison', 'Initials': 'E', 'LastName': 'Luthy', 'Affiliation': 'Department of Human Sciences, The Ohio State University, Columbus, OH, United States.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Moore', 'Affiliation': 'College of Nursing, Columbus, OH, United States.'}, {'ForeName': 'Jodi', 'Initials': 'J', 'LastName': 'Ford', 'Affiliation': 'College of Nursing, Columbus, OH, United States.'}]",JMIR mental health,['10.2196/18244']
2925,32966714,Cardiovascular Outcomes with Ertugliflozin in Type 2 Diabetes.,"BACKGROUND


The cardiovascular effects of ertugliflozin, an inhibitor of sodium-glucose cotransporter 2, have not been established.
METHODS


In a multicenter, double-blind trial, we randomly assigned patients with type 2 diabetes and atherosclerotic cardiovascular disease to receive 5 mg or 15 mg of ertugliflozin or placebo once daily. With the data from the two ertugliflozin dose groups pooled for analysis, the primary objective was to show the noninferiority of ertugliflozin to placebo with respect to the primary outcome, major adverse cardiovascular events (a composite of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke). The noninferiority margin was 1.3 (upper boundary of a 95.6% confidence interval for the hazard ratio [ertugliflozin vs. placebo] for major adverse cardiovascular events). The first key secondary outcome was a composite of death from cardiovascular causes or hospitalization for heart failure.
RESULTS


A total of 8246 patients underwent randomization and were followed for a mean of 3.5 years. Among 8238 patients who received at least one dose of ertugliflozin or placebo, a major adverse cardiovascular event occurred in 653 of 5493 patients (11.9%) in the ertugliflozin group and in 327 of 2745 patients (11.9%) in the placebo group (hazard ratio, 0.97; 95.6% confidence interval [CI], 0.85 to 1.11; P<0.001 for noninferiority). Death from cardiovascular causes or hospitalization for heart failure occurred in 444 of 5499 patients (8.1%) in the ertugliflozin group and in 250 of 2747 patients (9.1%) in the placebo group (hazard ratio, 0.88; 95.8% CI, 0.75 to 1.03; P = 0.11 for superiority). The hazard ratio for death from cardiovascular causes was 0.92 (95.8% CI, 0.77 to 1.11), and the hazard ratio for death from renal causes, renal replacement therapy, or doubling of the serum creatinine level was 0.81 (95.8% CI, 0.63 to 1.04). Amputations were performed in 54 patients (2.0%) who received the 5-mg dose of ertugliflozin and in 57 patients (2.1%) who received the 15-mg dose, as compared with 45 patients (1.6%) who received placebo.
CONCLUSIONS


Among patients with type 2 diabetes and atherosclerotic cardiovascular disease, ertugliflozin was noninferior to placebo with respect to major adverse cardiovascular events. (Funded by Merck Sharp & Dohme and Pfizer; VERTIS CV ClinicalTrials.gov number, NCT01986881.).",2020,The hazard ratio for death from cardiovascular causes was 0.92,"['Type 2 Diabetes', 'patients with type 2 diabetes and atherosclerotic cardiovascular disease to', '8238 patients who received at least one dose of', 'patients with type 2 diabetes and atherosclerotic cardiovascular disease', '8246 patients underwent randomization and were followed for a mean of 3.5 years']","['Ertugliflozin', 'ertugliflozin vs. placebo', 'placebo', 'receive 5 mg or 15 mg of ertugliflozin or placebo', 'ertugliflozin or placebo', 'ertugliflozin']","['hazard ratio for death from cardiovascular causes', 'Cardiovascular Outcomes', 'Amputations', 'adverse cardiovascular event', 'composite of death from cardiovascular causes or hospitalization for heart failure', 'major adverse cardiovascular events (a composite of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke', 'hazard ratio for death from renal causes, renal replacement therapy, or doubling of the serum creatinine level', 'Death from cardiovascular causes or hospitalization for heart failure']","[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C4079805', 'cui_str': 'ertugliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}]",8246.0,0.755502,The hazard ratio for death from cardiovascular causes was 0.92,"[{'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Cannon', 'Affiliation': ""From the Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston (C.P.C.); AdventHealth Translational Research Institute, Orlando, FL (R.P.); the University of Tennessee Health Science Center, Memphis (S.D.-J.); Pfizer, Groton, CT (J.M., U.M., R.F., S.G.T.); Merck, Kenilworth, NJ (S.H., I.G.); the Department of Endocrinology, University of Nantes, Nantes, France (B.C.); Rutgers School of Public Health and Rutgers Cancer Institute of New Jersey, New Brunswick (W.J.S.); Pfizer, Berlin (S.G.); the Unit of Cardiology, Karolinska Institute and Karolinska University Hospital, Stockholm (F.C.); the University of Toronto, Toronto (D.Z.I.C); and the University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.).""}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Pratley', 'Affiliation': ""From the Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston (C.P.C.); AdventHealth Translational Research Institute, Orlando, FL (R.P.); the University of Tennessee Health Science Center, Memphis (S.D.-J.); Pfizer, Groton, CT (J.M., U.M., R.F., S.G.T.); Merck, Kenilworth, NJ (S.H., I.G.); the Department of Endocrinology, University of Nantes, Nantes, France (B.C.); Rutgers School of Public Health and Rutgers Cancer Institute of New Jersey, New Brunswick (W.J.S.); Pfizer, Berlin (S.G.); the Unit of Cardiology, Karolinska Institute and Karolinska University Hospital, Stockholm (F.C.); the University of Toronto, Toronto (D.Z.I.C); and the University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.).""}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Dagogo-Jack', 'Affiliation': ""From the Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston (C.P.C.); AdventHealth Translational Research Institute, Orlando, FL (R.P.); the University of Tennessee Health Science Center, Memphis (S.D.-J.); Pfizer, Groton, CT (J.M., U.M., R.F., S.G.T.); Merck, Kenilworth, NJ (S.H., I.G.); the Department of Endocrinology, University of Nantes, Nantes, France (B.C.); Rutgers School of Public Health and Rutgers Cancer Institute of New Jersey, New Brunswick (W.J.S.); Pfizer, Berlin (S.G.); the Unit of Cardiology, Karolinska Institute and Karolinska University Hospital, Stockholm (F.C.); the University of Toronto, Toronto (D.Z.I.C); and the University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.).""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Mancuso', 'Affiliation': ""From the Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston (C.P.C.); AdventHealth Translational Research Institute, Orlando, FL (R.P.); the University of Tennessee Health Science Center, Memphis (S.D.-J.); Pfizer, Groton, CT (J.M., U.M., R.F., S.G.T.); Merck, Kenilworth, NJ (S.H., I.G.); the Department of Endocrinology, University of Nantes, Nantes, France (B.C.); Rutgers School of Public Health and Rutgers Cancer Institute of New Jersey, New Brunswick (W.J.S.); Pfizer, Berlin (S.G.); the Unit of Cardiology, Karolinska Institute and Karolinska University Hospital, Stockholm (F.C.); the University of Toronto, Toronto (D.Z.I.C); and the University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.).""}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Huyck', 'Affiliation': ""From the Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston (C.P.C.); AdventHealth Translational Research Institute, Orlando, FL (R.P.); the University of Tennessee Health Science Center, Memphis (S.D.-J.); Pfizer, Groton, CT (J.M., U.M., R.F., S.G.T.); Merck, Kenilworth, NJ (S.H., I.G.); the Department of Endocrinology, University of Nantes, Nantes, France (B.C.); Rutgers School of Public Health and Rutgers Cancer Institute of New Jersey, New Brunswick (W.J.S.); Pfizer, Berlin (S.G.); the Unit of Cardiology, Karolinska Institute and Karolinska University Hospital, Stockholm (F.C.); the University of Toronto, Toronto (D.Z.I.C); and the University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.).""}, {'ForeName': 'Urszula', 'Initials': 'U', 'LastName': 'Masiukiewicz', 'Affiliation': ""From the Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston (C.P.C.); AdventHealth Translational Research Institute, Orlando, FL (R.P.); the University of Tennessee Health Science Center, Memphis (S.D.-J.); Pfizer, Groton, CT (J.M., U.M., R.F., S.G.T.); Merck, Kenilworth, NJ (S.H., I.G.); the Department of Endocrinology, University of Nantes, Nantes, France (B.C.); Rutgers School of Public Health and Rutgers Cancer Institute of New Jersey, New Brunswick (W.J.S.); Pfizer, Berlin (S.G.); the Unit of Cardiology, Karolinska Institute and Karolinska University Hospital, Stockholm (F.C.); the University of Toronto, Toronto (D.Z.I.C); and the University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.).""}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Charbonnel', 'Affiliation': ""From the Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston (C.P.C.); AdventHealth Translational Research Institute, Orlando, FL (R.P.); the University of Tennessee Health Science Center, Memphis (S.D.-J.); Pfizer, Groton, CT (J.M., U.M., R.F., S.G.T.); Merck, Kenilworth, NJ (S.H., I.G.); the Department of Endocrinology, University of Nantes, Nantes, France (B.C.); Rutgers School of Public Health and Rutgers Cancer Institute of New Jersey, New Brunswick (W.J.S.); Pfizer, Berlin (S.G.); the Unit of Cardiology, Karolinska Institute and Karolinska University Hospital, Stockholm (F.C.); the University of Toronto, Toronto (D.Z.I.C); and the University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.).""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Frederich', 'Affiliation': ""From the Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston (C.P.C.); AdventHealth Translational Research Institute, Orlando, FL (R.P.); the University of Tennessee Health Science Center, Memphis (S.D.-J.); Pfizer, Groton, CT (J.M., U.M., R.F., S.G.T.); Merck, Kenilworth, NJ (S.H., I.G.); the Department of Endocrinology, University of Nantes, Nantes, France (B.C.); Rutgers School of Public Health and Rutgers Cancer Institute of New Jersey, New Brunswick (W.J.S.); Pfizer, Berlin (S.G.); the Unit of Cardiology, Karolinska Institute and Karolinska University Hospital, Stockholm (F.C.); the University of Toronto, Toronto (D.Z.I.C); and the University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.).""}, {'ForeName': 'Silvina', 'Initials': 'S', 'LastName': 'Gallo', 'Affiliation': ""From the Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston (C.P.C.); AdventHealth Translational Research Institute, Orlando, FL (R.P.); the University of Tennessee Health Science Center, Memphis (S.D.-J.); Pfizer, Groton, CT (J.M., U.M., R.F., S.G.T.); Merck, Kenilworth, NJ (S.H., I.G.); the Department of Endocrinology, University of Nantes, Nantes, France (B.C.); Rutgers School of Public Health and Rutgers Cancer Institute of New Jersey, New Brunswick (W.J.S.); Pfizer, Berlin (S.G.); the Unit of Cardiology, Karolinska Institute and Karolinska University Hospital, Stockholm (F.C.); the University of Toronto, Toronto (D.Z.I.C); and the University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.).""}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Cosentino', 'Affiliation': ""From the Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston (C.P.C.); AdventHealth Translational Research Institute, Orlando, FL (R.P.); the University of Tennessee Health Science Center, Memphis (S.D.-J.); Pfizer, Groton, CT (J.M., U.M., R.F., S.G.T.); Merck, Kenilworth, NJ (S.H., I.G.); the Department of Endocrinology, University of Nantes, Nantes, France (B.C.); Rutgers School of Public Health and Rutgers Cancer Institute of New Jersey, New Brunswick (W.J.S.); Pfizer, Berlin (S.G.); the Unit of Cardiology, Karolinska Institute and Karolinska University Hospital, Stockholm (F.C.); the University of Toronto, Toronto (D.Z.I.C); and the University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.).""}, {'ForeName': 'Weichung J', 'Initials': 'WJ', 'LastName': 'Shih', 'Affiliation': ""From the Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston (C.P.C.); AdventHealth Translational Research Institute, Orlando, FL (R.P.); the University of Tennessee Health Science Center, Memphis (S.D.-J.); Pfizer, Groton, CT (J.M., U.M., R.F., S.G.T.); Merck, Kenilworth, NJ (S.H., I.G.); the Department of Endocrinology, University of Nantes, Nantes, France (B.C.); Rutgers School of Public Health and Rutgers Cancer Institute of New Jersey, New Brunswick (W.J.S.); Pfizer, Berlin (S.G.); the Unit of Cardiology, Karolinska Institute and Karolinska University Hospital, Stockholm (F.C.); the University of Toronto, Toronto (D.Z.I.C); and the University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.).""}, {'ForeName': 'Ira', 'Initials': 'I', 'LastName': 'Gantz', 'Affiliation': ""From the Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston (C.P.C.); AdventHealth Translational Research Institute, Orlando, FL (R.P.); the University of Tennessee Health Science Center, Memphis (S.D.-J.); Pfizer, Groton, CT (J.M., U.M., R.F., S.G.T.); Merck, Kenilworth, NJ (S.H., I.G.); the Department of Endocrinology, University of Nantes, Nantes, France (B.C.); Rutgers School of Public Health and Rutgers Cancer Institute of New Jersey, New Brunswick (W.J.S.); Pfizer, Berlin (S.G.); the Unit of Cardiology, Karolinska Institute and Karolinska University Hospital, Stockholm (F.C.); the University of Toronto, Toronto (D.Z.I.C); and the University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.).""}, {'ForeName': 'Steven G', 'Initials': 'SG', 'LastName': 'Terra', 'Affiliation': ""From the Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston (C.P.C.); AdventHealth Translational Research Institute, Orlando, FL (R.P.); the University of Tennessee Health Science Center, Memphis (S.D.-J.); Pfizer, Groton, CT (J.M., U.M., R.F., S.G.T.); Merck, Kenilworth, NJ (S.H., I.G.); the Department of Endocrinology, University of Nantes, Nantes, France (B.C.); Rutgers School of Public Health and Rutgers Cancer Institute of New Jersey, New Brunswick (W.J.S.); Pfizer, Berlin (S.G.); the Unit of Cardiology, Karolinska Institute and Karolinska University Hospital, Stockholm (F.C.); the University of Toronto, Toronto (D.Z.I.C); and the University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.).""}, {'ForeName': 'David Z I', 'Initials': 'DZI', 'LastName': 'Cherney', 'Affiliation': ""From the Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston (C.P.C.); AdventHealth Translational Research Institute, Orlando, FL (R.P.); the University of Tennessee Health Science Center, Memphis (S.D.-J.); Pfizer, Groton, CT (J.M., U.M., R.F., S.G.T.); Merck, Kenilworth, NJ (S.H., I.G.); the Department of Endocrinology, University of Nantes, Nantes, France (B.C.); Rutgers School of Public Health and Rutgers Cancer Institute of New Jersey, New Brunswick (W.J.S.); Pfizer, Berlin (S.G.); the Unit of Cardiology, Karolinska Institute and Karolinska University Hospital, Stockholm (F.C.); the University of Toronto, Toronto (D.Z.I.C); and the University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.).""}, {'ForeName': 'Darren K', 'Initials': 'DK', 'LastName': 'McGuire', 'Affiliation': ""From the Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston (C.P.C.); AdventHealth Translational Research Institute, Orlando, FL (R.P.); the University of Tennessee Health Science Center, Memphis (S.D.-J.); Pfizer, Groton, CT (J.M., U.M., R.F., S.G.T.); Merck, Kenilworth, NJ (S.H., I.G.); the Department of Endocrinology, University of Nantes, Nantes, France (B.C.); Rutgers School of Public Health and Rutgers Cancer Institute of New Jersey, New Brunswick (W.J.S.); Pfizer, Berlin (S.G.); the Unit of Cardiology, Karolinska Institute and Karolinska University Hospital, Stockholm (F.C.); the University of Toronto, Toronto (D.Z.I.C); and the University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2004967']
2926,32979939,"High-dose and low-dose varenicline for smoking cessation in adolescents: a randomised, placebo-controlled trial.","BACKGROUND


Although cigarette smoking typically begins in adolescence, evidence for successful pharmacological smoking cessation interventions for this population is scarce. In adult smokers, varenicline is the most effective single pharmacotherapy. The aim of this study was to assess the efficacy and tolerability of varenicline for smoking cessation in adolescents.
METHODS


We did a randomised, placebo-controlled trial with adolescent smokers aged 12-19 years who were seeking treatment to quit at 57 outpatient centres (in the USA, Russia, South Korea, Taiwan, Canada, and Georgia). Participants were randomly assigned (1:1:1) to receive 12 weeks of high-dose varenicline (1 mg twice daily; 0·5 mg twice daily if bodyweight ≤55 kg), low-dose varenicline (0·5 mg twice daily; 0·5 mg once daily if bodyweight ≤55 kg), or placebo, then followed up for 40 additional weeks. At all visits, participants received brief, developmentally tailored smoking cessation counselling (<10 min per session) delivered by a trained counsellor. The primary efficacy outcome was continuous abstinence from weeks 9 to 12, measured via a Nicotine Use Inventory and confirmed by urine cotinine testing. The primary tolerability outcome was frequency of treatment-emergent adverse events, including neuropsychiatric adverse events, occurring after the first dose and within 30 days of the last dose of study medication. This trial is registered with ClinicalTrials.gov, NCT01312909.
FINDINGS


Between April 26, 2011, and Jan 18, 2018, 312 participants were enrolled and completed participation in the study: 109 in the high-dose varenicline group, 103 in the low-dose varenicline group, and 100 in the placebo group. The continuous abstinence rates from week 9 to 12 were 20% (22 of 109) in the high-dose varenicline group, 27% (28 of 103) in the low-dose varenicline group, and 18% (18 of 100) in the placebo group. Abstinence rates between high-dose varenicline and placebo groups (odds ratio [OR] 1·18 [95% CI 0·59-2·37]; p=0·63) and between low-dose varenicline and placebo groups (1·73 [0·88-3·39]; p=0·11) did not differ significantly. Treatment-emergent adverse events occurred in 65 (60%) of 108 participants in the high-dose group, 53 (53%) of 100 in the low-dose group, and 52 (53%) of 99 in the placebo group, and most were rated as mild. Neuropsychiatric treatment-emergent adverse events occurred in 18 (17%) of 108 participants in the high-dose group, 11 (11%) of 100 in the low-dose group, and 12 (12%) of 99 in the placebo group, and none was rated as severe.
INTERPRETATION


This trial did not show an advantage in abstinence with varenicline compared with placebo among adolescent smokers. The rates of treatment-emergent adverse events were similar to those in previous trials of adult smokers, raising no new tolerability signals. These findings do not support the use of varenicline as a first-line pharmacotherapy for smoking cessation in adolescents.
FUNDING


Pfizer.",2020,"Neuropsychiatric treatment-emergent adverse events occurred in 18 (17%) of 108 participants in the high-dose group, 11 (11%) of 100 in the low-dose group, and 12 (12%) of 99 in the placebo group, and none was rated as severe.
","['adolescent smokers', 'adolescents', 'adolescent smokers aged 12-19 years who were seeking treatment to quit at 57 outpatient centres (in the USA, Russia, South Korea, Taiwan, Canada, and Georgia', 'Between April 26, 2011, and Jan 18, 2018, 312 participants were enrolled and completed participation in the study: 109 in the high-dose varenicline group, 103 in the low-dose varenicline group, and 100 in the placebo group']","['placebo', 'High-dose and low-dose varenicline', 'varenicline', 'tailored smoking cessation counselling']","['continuous abstinence from weeks 9 to 12, measured via a Nicotine Use Inventory and confirmed by urine cotinine testing', 'Abstinence rates', 'rates of treatment-emergent adverse events', 'Treatment-emergent adverse events', 'severe', 'continuous abstinence rates', 'frequency of treatment-emergent adverse events, including neuropsychiatric adverse events', 'efficacy and tolerability', 'Neuropsychiatric treatment-emergent adverse events']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0035970', 'cui_str': 'Russian federation - Europe'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0017452', 'cui_str': 'Georgia state'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C4517706', 'cui_str': '312'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0303400', 'cui_str': 'Indium-109'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C1697737', 'cui_str': 'Urine cotinine test'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",312.0,0.620913,"Neuropsychiatric treatment-emergent adverse events occurred in 18 (17%) of 108 participants in the high-dose group, 11 (11%) of 100 in the low-dose group, and 12 (12%) of 99 in the placebo group, and none was rated as severe.
","[{'ForeName': 'Kevin M', 'Initials': 'KM', 'LastName': 'Gray', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA. Electronic address: graykm@musc.edu.'}, {'ForeName': 'Mark L', 'Initials': 'ML', 'LastName': 'Rubinstein', 'Affiliation': 'Department of Pediatrics, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Judith J', 'Initials': 'JJ', 'LastName': 'Prochaska', 'Affiliation': 'Department of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'DuBrava', 'Affiliation': 'Pfizer, New York, NY, USA.'}, {'ForeName': 'Ann R', 'Initials': 'AR', 'LastName': 'Holstein', 'Affiliation': 'Pfizer, New York, NY, USA.'}, {'ForeName': 'Larry', 'Initials': 'L', 'LastName': 'Samuels', 'Affiliation': 'Pfizer, New York, NY, USA.'}, {'ForeName': 'Thomas D', 'Initials': 'TD', 'LastName': 'McRae', 'Affiliation': 'Pfizer, New York, NY, USA.'}]",The Lancet. Child & adolescent health,['10.1016/S2352-4642(20)30243-1']
2927,32980725,Radiomic features of magnetic resonance images as novel preoperative predictive factors of bone invasion in meningiomas.,"PURPOSE


Bone invasion in meningiomas is a prognostic determinant, and a priori knowledge may alter surgical techniques. Here, we aim to predict bone invasion in meningiomas using radiomic signatures based on preoperative, contrast-enhanced T1-weighted (T1C) and T2-weighted (T2) magnetic resonance imaging (MRI).
METHODS


In this retrospective study, 490 patients diagnosed with meningiomas, including WHO grade I (448cases), grade II (38cases), and grade III (4cases), were enrolled and 213 out of 490 cases (43.5 %) had bone invasion. The patients were randomly divided into training (n = 343) and test (n = 147) datasets at a 7:3 ratio. For each patient, 1227 radiomic features were extracted from T1C and T2, respectively. Spearman's correlation and least absolute shrinkage and selection operator (LASSO) regression analyses were performed to select the most informative features. Subsequently, a 5-fold cross-validation was used to compare the performance of different classification algorithms, and logistic regression was chosen to predict the risk of bone invasion.
RESULTS


Eight radiomic features were selected from T1C and T2 respectively, and three models were built using radiomic features. The radiomic models derived from T1C alone or a combination of T1C and T2 had the best performance in predicting risk of bone invasion, with areas under the curve in the training dataset of 0.714 [95 % CI, 0.660-0.768] and 0.722 [95 % CI, 0.668-0.776] and in the test datasets of 0.715 [95 % CI, 0.632-0.798] and 0.713 [95 % CI, 0.628-0.798], respectively.
CONCLUSIONS


The radiomic model may aid clinicians with preoperative prediction of bone invasion by meningiomas, which can help in predicting prognosis and devising surgical strategies.",2020,"The radiomic models derived from T1C alone or a combination of T1C and T2 had the best performance in predicting risk of bone invasion, with areas under the curve in the training dataset of 0.714 [95 % CI, 0.660-0.768] and 0.722","['490 patients diagnosed with meningiomas, including WHO grade I (448cases), grade II (38cases), and grade III (4cases), were enrolled and 213 out of 490 cases (43.5 %) had bone invasion', 'bone invasion in meningiomas']","['magnetic resonance images', 'radiomic signatures based on preoperative, contrast-enhanced T1-weighted (T1C) and T2-weighted (T2) magnetic resonance imaging (MRI']",['risk of bone invasion'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0025286', 'cui_str': 'Meningioma'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0205617', 'cui_str': 'Poorly differentiated'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C1269955', 'cui_str': 'Tumour invasion'}]","[{'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C1269955', 'cui_str': 'Tumour invasion'}]",490.0,0.0309829,"The radiomic models derived from T1C alone or a combination of T1C and T2 had the best performance in predicting risk of bone invasion, with areas under the curve in the training dataset of 0.714 [95 % CI, 0.660-0.768] and 0.722","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Second Clinical School, Lanzhou University, Lanzhou, China; Department of Radiology, Lanzhou University Second Hospital, Lanzhou, China; Key Laboratory of Medical Imaging of Gansu Province, Lanzhou, China.'}, {'ForeName': 'Jianqing', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Philips Healthcare, Shanghai, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Han', 'Affiliation': 'Second Clinical School, Lanzhou University, Lanzhou, China; Department of Radiology, Lanzhou University Second Hospital, Lanzhou, China.'}, {'ForeName': 'Zhiyong', 'Initials': 'Z', 'LastName': 'Zhao', 'Affiliation': 'Second Clinical School, Lanzhou University, Lanzhou, China; Department of Radiology, Lanzhou University Second Hospital, Lanzhou, China.'}, {'ForeName': 'Yuntai', 'Initials': 'Y', 'LastName': 'Cao', 'Affiliation': 'Second Clinical School, Lanzhou University, Lanzhou, China; Department of Radiology, Lanzhou University Second Hospital, Lanzhou, China.'}, {'ForeName': 'Guojin', 'Initials': 'G', 'LastName': 'Zhang', 'Affiliation': 'Second Clinical School, Lanzhou University, Lanzhou, China; Department of Radiology, Lanzhou University Second Hospital, Lanzhou, China.'}, {'ForeName': 'Junlin', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Second Clinical School, Lanzhou University, Lanzhou, China; Department of Radiology, Lanzhou University Second Hospital, Lanzhou, China. Electronic address: lzuzjl601@163.com.'}]",European journal of radiology,['10.1016/j.ejrad.2020.109287']
2928,32980764,Comparative dose-response study of hyperbaric ropivacaine for spinal anesthesia for cesarean delivery in singleton versus twin pregnancies.,"STUDY OBJECTIVE


It is controversial whether local anesthetic dose requirement for spinal anesthesia for cesarean delivery differs between patients with singleton and patients with multiple gestation pregnancies. The aim of this study was to determine and compare the ED 50  and ED 90  for hyperbaric ropivacaine used for spinal anesthesia for cesarean delivery in patients with singleton pregnancies versus patients with twin pregnancies.
DESIGN


Prospective, randomized, comparative dose-finding study.
SETTING


Operating room, Women's Hospital, Zhejiang University School of Medicine.
PATIENTS


100 patients with singleton pregnancies (Group S) and 100 patients with twin pregnancies (Group T) presenting for scheduled cesarean delivery under combined spinal-epidural anesthesia were enrolled in the study.
INTERVENTIONS


Patients in Group S or Group T were randomly allocated to receive 9.5, 11, 12.5, 14 or 15.5 mg of hyperbaric ropivacaine intrathecally. A dose was considered effective when it achieved a bilateral sensory block level at the T6 dermatome or above within 10 min after intrathecal injection, there was no numerical rating scale (NRS) pain score ≥ 3 intraoperatively, and there was no requirement for epidural supplementation at any time during anesthesia and operation. Values for ED 50  and ED 90  for ropivacaine were determined using probit regression. The difference in ropivacaine dose requirement between patients with singleton pregnancies and patients with twin pregnancies was assessed by calculating relative median potency.
MEASUREMENTS


Success rates for different intrathecal doses of ropivacaine, side effects and neonatal outcomes were recorded.
MAIN RESULTS


The estimated (95% confidence interval) values for ED 50  and ED 90  of intrathecal ropivacaine in patients with singleton pregnancies were 11.2 (10.2 to 12.0) mg and 15.7 (14.4 to 18.3) mg, respectively. The values for ED 50  and ED 90  in patients with twin pregnancies were 10.5 (9.5 to 11.3) mg and 14.8 mg (13.6 to 17.0) mg, respectively. The estimate of relative median potency for ropivacaine between patients with singleton and twin pregnancies was 0.94 (95% confidence interval 0.83 to 1.04).
CONCLUSION


Patients with singleton and twin pregnancies have similar dose requirement for hyperbaric ropivacaine used for spinal anesthesia for cesarean delivery in the setting of combined spinal-epidural (CSE) anesthesia, no opioids, low weight cohort, insertion with the patients in the right lateral position, and norepinephrine boluses.",2020,"The estimated (95% confidence interval) values for ED 50  and ED 90  of intrathecal ropivacaine in patients with singleton pregnancies were 11.2 (10.2 to 12.0) mg and 15.7 (14.4 to 18.3) mg, respectively.","['100 patients with singleton pregnancies (Group S) and 100 patients with twin pregnancies (Group T) presenting for scheduled cesarean delivery under combined spinal-epidural anesthesia were enrolled in the study', 'Patients with singleton and twin pregnancies', 'patients with singleton pregnancies versus patients with twin pregnancies', 'spinal anesthesia for cesarean delivery in singleton versus twin pregnancies', 'patients with singleton and patients with multiple gestation pregnancies', 'patients with singleton and twin pregnancies', 'patients with singleton pregnancies and patients with twin pregnancies', ""Operating room, Women's Hospital, Zhejiang University School of Medicine""]","['ropivacaine', 'hyperbaric ropivacaine', 'intrathecal ropivacaine', 'spinal anesthesia', 'hyperbaric ropivacaine intrathecally', 'Patients in Group S or Group T']","['numerical rating scale (NRS) pain score', 'side effects and neonatal outcomes', 'bilateral sensory block level', 'relative median potency']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0441853', 'cui_str': 'Group S'}, {'cui': 'C0152150', 'cui_str': 'Twin pregnancy'}, {'cui': 'C0036669', 'cui_str': 'Group T'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0002913', 'cui_str': 'Epidural anesthesia'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0032989', 'cui_str': 'Multiple pregnancy'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0677897', 'cui_str': 'Intrathecal route'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441853', 'cui_str': 'Group S'}, {'cui': 'C0036669', 'cui_str': 'Group T'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",100.0,0.0877961,"The estimated (95% confidence interval) values for ED 50  and ED 90  of intrathecal ropivacaine in patients with singleton pregnancies were 11.2 (10.2 to 12.0) mg and 15.7 (14.4 to 18.3) mg, respectively.","[{'ForeName': 'Zhong', 'Initials': 'Z', 'LastName': 'Mei', 'Affiliation': ""Department of Anesthesiology, Women's Hospital, Zhejiang University School of Medicine, Hangzhou, China; Department of Anesthesiology, Zhejiang Xiaoshan Hospital, Hangzhou, China.""}, {'ForeName': 'Warwick D', 'Initials': 'WD', 'LastName': 'Ngan Kee', 'Affiliation': 'Department of Anesthesiology, Sidra Medicine, Doha, Qatar.'}, {'ForeName': 'Zhi-Min', 'Initials': 'ZM', 'LastName': 'Sheng', 'Affiliation': ""Department of Anesthesiology, Women's Hospital, Zhejiang University School of Medicine, Hangzhou, China.""}, {'ForeName': 'Li-Juan', 'Initials': 'LJ', 'LastName': 'Hu', 'Affiliation': ""Department of Anesthesiology, Women's Hospital, Zhejiang University School of Medicine, Hangzhou, China.""}, {'ForeName': 'Zhan-Huai', 'Initials': 'ZH', 'LastName': 'Wu', 'Affiliation': ""Department of Anesthesiology, Women's Hospital, Zhejiang University School of Medicine, Hangzhou, China.""}, {'ForeName': 'Chang-Cheng', 'Initials': 'CC', 'LastName': 'Lyu', 'Affiliation': ""Department of Anesthesiology, Women's Hospital, Zhejiang University School of Medicine, Hangzhou, China.""}, {'ForeName': 'Xin-Zhong', 'Initials': 'XZ', 'LastName': 'Chen', 'Affiliation': ""Department of Anesthesiology, Women's Hospital, Zhejiang University School of Medicine, Hangzhou, China.""}, {'ForeName': 'Xiao-Wei', 'Initials': 'XW', 'LastName': 'Qian', 'Affiliation': ""Department of Anesthesiology, Women's Hospital, Zhejiang University School of Medicine, Hangzhou, China. Electronic address: qianxw@zju.edu.cn.""}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.110068']
2929,32962980,A Prognostic Model Based on PAM50 and Clinical Variables (PAM50MET) for Metastatic Hormone Receptor-positive HER2-negative Breast Cancer.,"PURPOSE


Predicting prognosis in HR + /HER2 -  metastatic breast cancer (MBC) might be clinically useful; however, no validated prognostic biomarkers exist in this setting to date.
PATIENTS AND METHODS


In phase III, EGF30008 trial, 484 patients with HER2 -  MBC who received letrozole and placebo or lapatinib were selected. PAM50 data, ECOG performance status, visceral disease, number of metastasis, biopsy type, and age were evaluated. A progression-free survival (PFS) Cox model was evaluated. The final model (PAM50MET) with a prespecified cutoff was validated in patients ( n  = 261) with HR + /HER2 -  advanced breast cancer (aBC) from BOLERO-2 (phase III trial that evaluated exemestane and placebo or everolimus).
RESULTS


In EGF30008, prognostic models with PAM50 plus clinical variables yielded higher C-index values versus models with only PAM50 or clinical variables. The PAM50MET model combined 21 variables: 2 PAM50 subtypes, basal signature, 14 genes, and 4 clinical variables. In EGF30008, the optimized cutoff was associated with PFS [HR = 0.37; 95% confidence interval (CI), 0.29-0.47;  P  < 0.0001] and overall survival (OS; HR = 0.37; 95% CI, 0.27-0.51;  P  < 0.0001). The median (months; 95% CI) PFS and OS were 22.24 (19.0-24.9) and not reached in PAM50MET-low versus 9.13 (8.15-11.0) and 33.0 (28.0-40.0) in PAM50MET-high groups, respectively. In BOLERO-2, the PAM50MET-low was associated with better PFS (HR = 0.72; 95% CI, 0.53-0.96;  P  = 0.028) and OS (HR = 0.51; 95% CI, 0.35-0.69;  P  < 0.0001). The median (months) (95% CI) PFS and OS were 6.93 (5.57-11.0) and 36.9 (33.4-NA) in PAM50MET-low versus 5.23 (4.2-6.8) and 23.5 (20.2-28.3) in PAM50MET-high groups, respectively.
CONCLUSION


PAM50MET is prognostic in HR + /HER2 -  MBC, and further evaluation might help identify candidates for endocrine therapy only or novel therapies.",2020,"In BOLERO-2, the PAM50MET-low was associated with better PFS (HR=0.72; 95% CI 0.53-0.96;  P =0.028) and OS (HR=0.51; 95% CI 0.35-0.69;  P <0.0001).","['patients (n=261) with HR+/HER2-negative aBC from BOLERO-2', '484 patients with HER2-negative MBC who received']","['exemestane and placebo or everolimus', 'letrozole and placebo or lapatinib']","['A progression-free survival (PFS', 'PAM50 data, ECOG PS, visceral disease, number of metastasis, biopsy type, and age', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0152244', 'cui_str': 'Aneurysmal bone cyst'}, {'cui': 'C0244436', 'cui_str': 'Bolero'}, {'cui': 'C4087376', 'cui_str': 'HER2 negative'}, {'cui': 'C0065839', 'cui_str': 'Carbendazim'}]","[{'cui': 'C0851344', 'cui_str': 'exemestane'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C1506770', 'cui_str': 'lapatinib'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0430797', 'cui_str': 'Electrocorticogram'}, {'cui': 'C0442045', 'cui_str': 'Visceral'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449798', 'cui_str': 'Number of metastases'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",484.0,0.0728994,"In BOLERO-2, the PAM50MET-low was associated with better PFS (HR=0.72; 95% CI 0.53-0.96;  P =0.028) and OS (HR=0.51; 95% CI 0.35-0.69;  P <0.0001).","[{'ForeName': 'Aleix', 'Initials': 'A', 'LastName': 'Prat', 'Affiliation': 'Department of Medical Oncology, Hospital Clínic de Barcelona, Barcelona, Spain. alprat@clinic.cat parkerjs@email.unc.edu.'}, {'ForeName': 'Yi-Hsuan', 'Initials': 'YH', 'LastName': 'Tsai', 'Affiliation': 'Department of Genetics, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Tomás', 'Initials': 'T', 'LastName': 'Pascual', 'Affiliation': 'Department of Medical Oncology, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Laia', 'Initials': 'L', 'LastName': 'Paré', 'Affiliation': 'Department of Medical Oncology, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Adamo', 'Affiliation': 'Department of Medical Oncology, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Vidal', 'Affiliation': 'Department of Medical Oncology, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Fara', 'Initials': 'F', 'LastName': 'Brasó-Maristany', 'Affiliation': 'Department of Medical Oncology, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Galván', 'Affiliation': 'Department of Medical Oncology, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Jan Christoph', 'Initials': 'JC', 'LastName': 'Brase', 'Affiliation': 'Novartis Oncology, Basel, Switzerland.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Rodrik-Outmezguine', 'Affiliation': 'Novartis Pharmaceutical Corporation, East Hanover, New Jersey.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Johnston', 'Affiliation': 'Department of Medical Oncology, Royal Marsden Hospital, London, England.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Ciruelos', 'Affiliation': 'SOLTI Breast Cancer Cooperative Group, Barcelona, Spain.'}, {'ForeName': 'Joel S', 'Initials': 'JS', 'LastName': 'Parker', 'Affiliation': 'Department of Genetics, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina. alprat@clinic.cat parkerjs@email.unc.edu.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-2793']
2930,32962981,Cognitive Function Following Diabetic Ketoacidosis in Children With New-Onset or Previously Diagnosed Type 1 Diabetes.,"OBJECTIVE


This study assessed whether a single diabetic ketoacidosis (DKA) episode is associated with cognitive declines in children with newly diagnosed type 1 diabetes and whether the same is true in children who had previously been diagnosed after accounting for variations in glycemic control and other relevant factors.
RESEARCH DESIGN AND METHODS


We prospectively enrolled 758 children, 6-18 years old, who presented with DKA in a randomized multisite clinical trial evaluating intravenous fluid protocols for DKA treatment. DKA was moderate/severe in 430 children and mild in 328 children. A total of 392 children with DKA had new onset of type 1 diabetes, and the rest were previously diagnosed. Neurocognitive assessment occurred 2-6 months after the DKA episode. A comparison group of 376 children with type 1 diabetes, but no DKA exposure, was also enrolled.
RESULTS


Among all patients, moderate/severe DKA was associated with lower intelligence quotient (IQ) (β = -0.12,  P  < 0.001), item-color recall (β = -0.08,  P  = 0.010), and forward digit span (β = -0.06,  P  = 0.04). Among newly diagnosed patients, moderate/severe DKA was associated with lower item-color recall (β = -0.08,  P  = 0.04). Among previously diagnosed patients, repeated DKA exposure and higher HbA 1c  were independently associated with lower IQ (β = -0.10 and β = -0.09, respectively,  P  < 0.01) and higher HbA 1c  was associated with lower item-color recall (β = -0.10,  P  = 0.007) after hypoglycemia, diabetes duration, and socioeconomic status were accounted for.
CONCLUSIONS


A single DKA episode is associated with subtle memory declines soon after type 1 diabetes diagnosis. Sizable IQ declines are detectable in children with known diabetes, suggesting that DKA effects may be exacerbated in children with chronic exposure to hyperglycemia.",2020,"Among all patients, moderate/severe DKA was associated with lower intelligence quotient (IQ) (β = -0.12,  P  < 0.001), item-color recall (β = -0.08,  P  = 0.010), and forward digit span (β = -0.06,  P  = 0.04).","['children with newly diagnosed type 1 diabetes', 'children with chronic exposure to hyperglycemia', '430 children and mild in 328 children', '376 children with type 1 diabetes, but no DKA exposure, was also enrolled', 'children with known diabetes', 'Children With New-Onset or Previously Diagnosed Type 1 Diabetes', '392 children with DKA had new onset of type 1 diabetes, and the rest were previously diagnosed', 'We prospectively enrolled 758 children, 6-18 years old, who presented with DKA in a randomized multisite clinical trial evaluating intravenous fluid protocols for DKA treatment']",['DKA'],"['lower intelligence quotient (IQ', 'forward digit span', 'item-color recall', 'Cognitive Function', 'hypoglycemia, diabetes duration, and socioeconomic status', 'moderate/severe DKA', 'Neurocognitive assessment']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011880', 'cui_str': 'Diabetic ketoacidosis'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1289919', 'cui_str': 'Intravenous fluid'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0011880', 'cui_str': 'Diabetic ketoacidosis'}]","[{'cui': 'C0423903', 'cui_str': 'Low intelligence'}, {'cui': 'C0456149', 'cui_str': 'Intelligence quotient'}, {'cui': 'C0439780', 'cui_str': 'Forward'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0086996', 'cui_str': 'Socioeconomic Status'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0011880', 'cui_str': 'Diabetic ketoacidosis'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",758.0,0.0520046,"Among all patients, moderate/severe DKA was associated with lower intelligence quotient (IQ) (β = -0.12,  P  < 0.001), item-color recall (β = -0.08,  P  = 0.010), and forward digit span (β = -0.06,  P  = 0.04).","[{'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Ghetti', 'Affiliation': 'Department of Psychology, University of California, Davis, Davis, CA sghetti@ucdavis.edu.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Kuppermann', 'Affiliation': 'Department of Emergency Medicine, UC Davis Health, UC Davis School of Medicine, Sacramento, CA.'}, {'ForeName': 'Arleta', 'Initials': 'A', 'LastName': 'Rewers', 'Affiliation': ""Division of Emergency Medicine, Department of Pediatrics, Children's Hospital Colorado, University of Colorado School of Medicine, University of Colorado Denver, Aurora, CO.""}, {'ForeName': 'Sage R', 'Initials': 'SR', 'LastName': 'Myers', 'Affiliation': ""Division of Emergency Medicine, Department of Pediatrics, Children's Hospital of Philadelphia, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.""}, {'ForeName': 'Jeff E', 'Initials': 'JE', 'LastName': 'Schunk', 'Affiliation': 'Department of Pediatrics, University of Utah School of Medicine, Salt Lake City, UT.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Stoner', 'Affiliation': ""Division of Emergency Medicine, Department of Pediatrics, Nationwide Children's Hospital, The Ohio State University College of Medicine, Columbus, OH.""}, {'ForeName': 'Aris', 'Initials': 'A', 'LastName': 'Garro', 'Affiliation': 'Departments of Emergency Medicine and Pediatrics, Rhode Island Hospital, The Warren Alpert Medical School, Brown University, Providence, RI.'}, {'ForeName': 'Kimberly S', 'Initials': 'KS', 'LastName': 'Quayle', 'Affiliation': ""Division of Emergency Medicine, Department of Pediatrics, St. Louis Children's Hospital, Washington University School of Medicine in St. Louis, St. Louis, MO.""}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Brown', 'Affiliation': ""Division of Emergency Medicine, Department of Pediatrics, Children's National Medical Center, The School of Medicine & Health Sciences, The George Washington University, Washington, DC.""}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Trainor', 'Affiliation': ""Division of Emergency Medicine, Department of Pediatrics, Ann and Robert H. Lurie Children's Hospital of Chicago, Northwestern University Feinberg School of Medicine, Chicago, IL.""}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Tzimenatos', 'Affiliation': 'Department of Emergency Medicine, UC Davis Health, UC Davis School of Medicine, Sacramento, CA.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'DePiero', 'Affiliation': 'Division of Emergency Medicine, Nemours/Alfred I. duPont Hospital for Children, Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, PA.'}, {'ForeName': 'Julie K', 'Initials': 'JK', 'LastName': 'McManemy', 'Affiliation': ""Division of Emergency Medicine, Department of Pediatrics, Texas Children's Hospital, Baylor College of Medicine, Houston, TX.""}, {'ForeName': 'Lise E', 'Initials': 'LE', 'LastName': 'Nigrovic', 'Affiliation': ""Division of Emergency Medicine, Department of Pediatrics, Boston Children's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Maria Y', 'Initials': 'MY', 'LastName': 'Kwok', 'Affiliation': ""Division of Emergency Medicine, Department of Pediatrics, New York Presbyterian Morgan Stanley Children's Hospital, Vagelos College of Physicians and Surgeons, Columbia University, New York, NY.""}, {'ForeName': 'Clinton S', 'Initials': 'CS', 'LastName': 'Perry', 'Affiliation': 'Center for Mind and Brain, University of California, Davis, Davis, CA.'}, {'ForeName': 'Cody S', 'Initials': 'CS', 'LastName': 'Olsen', 'Affiliation': 'Department of Pediatrics, University of Utah School of Medicine, Salt Lake City, UT.'}, {'ForeName': 'T Charles', 'Initials': 'TC', 'LastName': 'Casper', 'Affiliation': 'Department of Pediatrics, University of Utah School of Medicine, Salt Lake City, UT.'}, {'ForeName': 'Nicole S', 'Initials': 'NS', 'LastName': 'Glaser', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes care,['10.2337/dc20-0187']
2931,32969700,Balance of group sizes in randomized controlled trials published in American Psychological Association journals.,"OBJECTIVE


We evaluated whether sample size differences between arms of two-arm parallel group randomized controlled trials (RCTs) published in American Psychological Association (APA)-affiliated journals were consistently smaller than expected by chance with simple randomization.
METHOD


We searched PsycINFO for two-arm parallel group RCTs in APA-affiliated journals published January 2007 to September 2017 that used individual randomization (1:1 allocation ratio), reported the number of participants randomized, and did not describe employing restrictive randomization (e.g., blocking). We queried authors because randomization processes were often not described in articles, and we conducted a post hoc logistic regression analysis to attempt to identify factors associated with overly balanced groups.
RESULTS


We identified 203 eligible trials, but after the author query, it was determined that only 115 used simple randomization. Among those 115 trials, there was a significantly greater number of trials with smaller sample size differences between trial arms than would be expected by chance ( p  < .001); 89 of 115 (77%) had differences in trial arm sample sizes smaller than the 50% prediction interval threshold for these differences. Greater proportionate imbalance may be associated with larger trial size (odds ratio of 0.27, 95% CI [0.08, 0.94] for  N  > 200 vs.  N  ≤ 100); greater balance may be more common in higher impact journals, though this was not statistically significant.
CONCLUSIONS


Education is needed to ensure that randomization procedures are implemented as intended and fully and accurately reported and that balanced group sample sizes are not understood as an indicator of trial quality. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"Greater proportionate imbalance may be associated with larger trial size (odds ratio of 0.27, 95% CI [0.08, 0.94] for  N  > 200 vs.  N  ≤ 100); greater balance may be more common in higher impact journals, though this was not statistically significant.
",[],[],[],[],[],[],,0.355944,"Greater proportionate imbalance may be associated with larger trial size (odds ratio of 0.27, 95% CI [0.08, 0.94] for  N  > 200 vs.  N  ≤ 100); greater balance may be more common in higher impact journals, though this was not statistically significant.
","[{'ForeName': 'Mara', 'Initials': 'M', 'LastName': 'Cañedo-Ayala', 'Affiliation': 'Lady Davis Institute for Medical Research.'}, {'ForeName': 'Danielle B', 'Initials': 'DB', 'LastName': 'Rice', 'Affiliation': 'Lady Davis Institute for Medical Research.'}, {'ForeName': 'Alexander W', 'Initials': 'AW', 'LastName': 'Levis', 'Affiliation': 'Department of Biostatistics.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Chiovitti', 'Affiliation': 'Lady Davis Institute for Medical Research.'}, {'ForeName': 'Brett D', 'Initials': 'BD', 'LastName': 'Thombs', 'Affiliation': 'Lady Davis Institute for Medical Research.'}]","Health psychology : official journal of the Division of Health Psychology, American Psychological Association",['10.1037/hea0001020']
2932,32966280,Molecular classification of the placebo effect in nausea.,"In this proof-of-concept study, we tested whether placebo effects can be monitored and predicted by plasma proteins. In a randomized controlled design, 90 participants were exposed to a nauseating stimulus on two separate days and were randomly allocated to placebo treatment or no treatment on the second day. Significant placebo effects on nausea, motion sickness, and (in females) gastric activity could be verified. Using label-free tandem mass spectrometry, 74 differentially regulated proteins were identified as correlates of the placebo effect. Gene ontology (GO) enrichment analyses identified acute-phase proteins and microinflammatory proteins to be involved, and the identified GO signatures predicted day-adjusted scores of nausea indices in the placebo group. We also performed GO enrichment analyses of specific plasma proteins predictable by the experimental factors or their interactions and identified 'grooming behavior' as a prominent hit. Finally, Receiver Operator Characteristics (ROC) allowed to identify plasma proteins differentiating placebo responders from non-responders, comprising immunoglobulins and proteins involved in oxidation reduction processes and complement activation. Plasma proteomics is a promising tool to identify molecular correlates and predictors of the placebo effect in humans.",2020,"Significant placebo effects on nausea, motion sickness, and (in females) gastric activity could be verified.",['90 participants were exposed to a nauseating stimulus on two separate days'],['placebo'],"['nausea', 'nausea, motion sickness, and (in females) gastric activity']","[{'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0026603', 'cui_str': 'Motion sickness'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",90.0,0.243193,"Significant placebo effects on nausea, motion sickness, and (in females) gastric activity could be verified.","[{'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Meissner', 'Affiliation': 'Institute of Medical Psychology, Faculty of Medicine, LMU Munich, Munich, Germany.'}, {'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Lutter', 'Affiliation': 'Institute of Diabetes and Obesity, Helmholtz Diabetes Center, Helmholtz Zentrum München, German Research Center for Environmental Health (GmbH), Neuherberg, Germany.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'von Toerne', 'Affiliation': 'Research Unit Protein Science, Helmholtz Zentrum München, German Research Center for Environmental Health (GmbH), Neuherberg, Germany.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Haile', 'Affiliation': 'Institute of Medical Psychology, Faculty of Medicine, LMU Munich, Munich, Germany.'}, {'ForeName': 'Stephen C', 'Initials': 'SC', 'LastName': 'Woods', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, Metabolic Diseases Institute, University of Cincinnati, Cincinnati, Ohio, United States of America.'}, {'ForeName': 'Verena', 'Initials': 'V', 'LastName': 'Hoffmann', 'Affiliation': 'Institute of Medical Psychology, Faculty of Medicine, LMU Munich, Munich, Germany.'}, {'ForeName': 'Uli', 'Initials': 'U', 'LastName': 'Ohmayer', 'Affiliation': 'Research Unit Protein Science, Helmholtz Zentrum München, German Research Center for Environmental Health (GmbH), Neuherberg, Germany.'}, {'ForeName': 'Stefanie M', 'Initials': 'SM', 'LastName': 'Hauck', 'Affiliation': 'Research Unit Protein Science, Helmholtz Zentrum München, German Research Center for Environmental Health (GmbH), Neuherberg, Germany.'}, {'ForeName': 'Matthias H', 'Initials': 'MH', 'LastName': 'Tschoep', 'Affiliation': 'Institute of Diabetes and Obesity, Helmholtz Diabetes Center, Helmholtz Zentrum München, German Research Center for Environmental Health (GmbH), Neuherberg, Germany.'}]",PloS one,['10.1371/journal.pone.0238533']
2933,32966830,"Neoadjuvant atezolizumab in combination with sequential nab-paclitaxel and anthracycline-based chemotherapy versus placebo and chemotherapy in patients with early-stage triple-negative breast cancer (IMpassion031): a randomised, double-blind, phase 3 trial.","BACKGROUND


Preferred neoadjuvant regimens for early-stage triple-negative breast cancer (TNBC) include anthracycline-cyclophosphamide and taxane-based chemotherapy. IMpassion031 compared efficacy and safety of atezolizumab versus placebo combined with nab-paclitaxel followed by doxorubicin plus cyclophosphamide as neoadjuvant treatment for early-stage TNBC.
METHODS


This double-blind, randomised, phase 3 study enrolled patients in 75 academic and community sites in 13 countries. Patients aged 18 years or older with previously untreated stage II-III histologically documented TNBC were randomly assigned (1:1) to receive chemotherapy plus intravenous atezolizumab at 840 mg or placebo every 2 weeks. Chemotherapy comprised of nab-paclitaxel at 125 mg/m 2  every week for 12 weeks followed by doxorubicin at 60 mg/m 2  and cyclophosphamide at 600 mg/m 2  every 2 weeks for 8 weeks, which was then followed by surgery. Stratification was by clinical breast cancer stage and programmed cell death ligand 1 (PD-L1) status. Co-primary endpoints were pathological complete response in all-randomised (ie, all randomly assigned patients in the intention-to-treat population) and PD-L1-positive (ie, patients with PD-L1-expressing tumour infiltrating immune cells covering ≥1% of tumour area) populations. This study is registered with ClinicalTrials.gov (NCT03197935), Eudra (CT2016-004734-22), and the Japan Pharmaceutical Information Center (JapicCTI-173630), and is ongoing.
FINDINGS


Between July 7, 2017, and Sept 24, 2019, 455 patients were recruited and assessed for eligibility. Of the 333 eligible patients, 165 were randomly assigned to receive atezolizumab plus chemotherapy and 168 to placebo plus chemotherapy. At data cutoff (April 3, 2020), median follow-up was 20·6 months (IQR 8·7-24·9) in the atezolizumab plus chemotherapy group and 19·8 months (8·1-24·5) in the placebo plus chemotherapy group. Pathological complete response was documented in 95 (58%, 95% CI 50-65) patients in the atezolizumab plus chemotherapy group and 69 (41%, 34-49) patients in the placebo plus chemotherapy group (rate difference 17%, 95% CI 6-27; one-sided p=0·0044 [significance boundary 0·0184]). In the PD-L1-positive population, pathological complete response was documented in 53 (69%, 95% CI 57-79) of 77 patients in the atezolizumab plus chemotherapy group versus 37 (49%, 38-61) of 75 patients in the placebo plus chemotherapy group (rate difference 20%, 95% CI 4-35; one-sided p=0·021 [significance boundary 0·0184]). In the neoadjuvant phase, grade 3-4 adverse events were balanced and treatment-related serious adverse events occurred in 37 (23%) and 26 (16%) patients, with one patient per group experiencing an unrelated grade 5 adverse event (traffic accident in the atezolizumab plus chemotherapy group and pneumonia in the placebo plus chemotherapy group).
INTERPRETATION


In patients with early-stage TNBC, neoadjuvant treatment with atezolizumab in combination with nab-paclitaxel and anthracycline-based chemotherapy significantly improved pathological complete response rates with an acceptable safety profile.
FUNDING


F Hoffmann-La Roche/Genentech.",2020,"Pathological complete response was documented in 95 (58%, 95% CI 50-65) patients in the atezolizumab plus chemotherapy group and 69 (41%, 34-49) patients in the placebo plus chemotherapy group (rate difference 17%, 95% CI 6-27; one-sided p=0·0044 [significance boundary 0·0184]).","['333 eligible patients', 'patients with early-stage triple-negative breast cancer (IMpassion031', 'Patients aged 18 years or older with previously untreated stage II-III', 'early-stage triple-negative breast cancer (TNBC', 'Between July 7, 2017, and Sept 24, 2019, 455 patients were recruited and assessed for eligibility', 'enrolled patients in 75 academic and community sites in 13 countries']","['sequential nab-paclitaxel and anthracycline-based chemotherapy versus placebo and chemotherapy', 'chemotherapy plus intravenous atezolizumab at 840 mg or placebo', 'Neoadjuvant atezolizumab', 'atezolizumab plus chemotherapy', 'atezolizumab in combination with nab-paclitaxel and anthracycline-based chemotherapy', 'placebo combined with nab-paclitaxel', 'Chemotherapy comprised of nab-paclitaxel', 'placebo plus chemotherapy', 'doxorubicin at 60 mg/m 2  and cyclophosphamide', 'atezolizumab', 'doxorubicin plus cyclophosphamide', 'anthracycline-cyclophosphamide and taxane-based chemotherapy']","['efficacy and safety', 'Pathological complete response', 'pathological complete response', 'pathological complete response rates', 'serious adverse events']","[{'cui': 'C4517724', 'cui_str': '333'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C3539878', 'cui_str': 'Triple-negative breast cancer'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0454664', 'cui_str': 'Country'}]","[{'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}, {'cui': 'C0003234', 'cui_str': 'Anthracycline'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C4708913', 'cui_str': '840'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0215136', 'cui_str': 'taxane'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",455.0,0.693364,"Pathological complete response was documented in 95 (58%, 95% CI 50-65) patients in the atezolizumab plus chemotherapy group and 69 (41%, 34-49) patients in the placebo plus chemotherapy group (rate difference 17%, 95% CI 6-27; one-sided p=0·0044 [significance boundary 0·0184]).","[{'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Mittendorf', 'Affiliation': ""Dana-Farber/Brigham and Women's Cancer Center, Boston, MA, USA. Electronic address: emittendorf@bwh.harvard.edu.""}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Carlos H', 'Initials': 'CH', 'LastName': 'Barrios', 'Affiliation': 'Centro de Pesquisa em Oncologia, Hospital São Lucas, Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Shigehira', 'Initials': 'S', 'LastName': 'Saji', 'Affiliation': 'Fukushima Medical University, Fukushima, Japan.'}, {'ForeName': 'Kyung Hae', 'Initials': 'KH', 'LastName': 'Jung', 'Affiliation': 'Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Hegg', 'Affiliation': 'University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Koehler', 'Affiliation': 'Gemeinschaftspraxis für Haematologie und Onkologie Langen, Langen, Germany.'}, {'ForeName': 'Joohyuk', 'Initials': 'J', 'LastName': 'Sohn', 'Affiliation': 'Yonsei Cancer Center, Yonsei University Health System, Seoul, South Korea.'}, {'ForeName': 'Hiroji', 'Initials': 'H', 'LastName': 'Iwata', 'Affiliation': 'Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'Melinda L', 'Initials': 'ML', 'LastName': 'Telli', 'Affiliation': 'School of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Cristiano', 'Initials': 'C', 'LastName': 'Ferrario', 'Affiliation': 'Jewish General Hospital-McGill University, Montréal, QC, Canada.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Punie', 'Affiliation': 'Department of General Medical Oncology and Multidisciplinary Breast Centre, Leuven Cancer Institute, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Frédérique', 'Initials': 'F', 'LastName': 'Penault-Llorca', 'Affiliation': 'Department of Biopathology, Centre Jean Perrin and University Clermont Auvergne/INSERM U1240, Clermont-Ferrand, France.'}, {'ForeName': 'Shilpen', 'Initials': 'S', 'LastName': 'Patel', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Anh Nguyen', 'Initials': 'AN', 'LastName': 'Duc', 'Affiliation': 'F Hoffmann-La Roche, Basel, Switzerland.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Liste-Hermoso', 'Affiliation': 'F Hoffmann-La Roche, Basel, Switzerland.'}, {'ForeName': 'Vidya', 'Initials': 'V', 'LastName': 'Maiya', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Luciana', 'Initials': 'L', 'LastName': 'Molinero', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Stephen Y', 'Initials': 'SY', 'LastName': 'Chui', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Harbeck', 'Affiliation': 'Breast Center, Department of Gynecology and Obstetrics and Comprehensive Cancer Center of the Ludwig-Maximilians-University, Munich, Germany.'}]","Lancet (London, England)",['10.1016/S0140-6736(20)31953-X']
2934,32966877,Real-world exposure to graphic warning labels on cigarette packages in US smokers: The CASA randomized trial protocol.,"BACKGROUND


The US lags behind >120 countries in implementing graphic warning labels (GWLs) on cigarette packs. US courts prevented implementation of FDA's 2012 rule requiring GWLs citing the need for more evidence on effectiveness. After more research, in 2020, the FDA proposed a revised rule mandating GWLs. This trial will test how the introduction of GWLs influence cognitions and behavior in US smokers.
METHOD


To investigate the ""real-world"" impact of GWLs in US smokers, we are conducting a randomized trial involving a 3-month intervention and 8-month follow-up. The study recruited California smokers between September 2016 through December 2019 and randomly assigned them into 3 groups (1) Blank Pack devoid of any cigarette branding; (2) GWL Pack featuring 1 of 3 rotating images added to blank pack; or (3) their usual Standard US Pack. Throughout the 3-month intervention, participants purchased study-packaged cigarettes and reported daily cognitions and behavior through ecological momentary assessments. We will validate self-reported tobacco use with saliva cotinine concentrations following the 3-month intervention and 8-month follow-up.
RESULTS


The trial enrolled 359 participants (average age 39 years; average cigarette consumption half a pack/day). The 3 study groups were balanced on age, gender, race-ethnicity, education and income (17% low income) as well as on smoking related variables.
CONCLUSIONS


This 3-month real-world randomized trial will test the effect of repackaging cigarettes from standard US packs to GWL plain packs on smokers' perceptions of the risks of smoking, their perception of the appeal of their cigarettes, and on their smoking behavior.",2020,"We will validate self-reported tobacco use with saliva cotinine concentrations following the 3-month intervention and 8-month follow-up.
","['US smokers', 'California smokers between September 2016 through December 2019 and randomly assigned them into 3 groups (1', '359 participants (average age 39\u202fyears; average cigarette consumption half a pack/day']","['Blank Pack devoid of any cigarette branding; (2) GWL Pack featuring 1 of 3 rotating images added to blank pack; or (3) their usual Standard US Pack', 'Real-world exposure to graphic warning labels', 'repackaging cigarettes from standard US packs to GWL plain packs']",[],"[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0459840', 'cui_str': 'Cigarette consumption'}, {'cui': 'C0184967', 'cui_str': 'Insertion of pack'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0184967', 'cui_str': 'Insertion of pack'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0231458', 'cui_str': 'Rotated'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}]",[],359.0,0.0172592,"We will validate self-reported tobacco use with saliva cotinine concentrations following the 3-month intervention and 8-month follow-up.
","[{'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Pierce', 'Affiliation': 'Cancer Control Program, Moores Cancer Center, UC San Diego, 3855 Health Sciences Drive, La Jolla, CA 92093-0901, United States; Department of Family Medicine and Public Health, UC San Diego, 9500 Gilman Drive, La Jolla, CA 92093, United States. Electronic address: jppierce@ucsd.edu.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Strong', 'Affiliation': 'Cancer Control Program, Moores Cancer Center, UC San Diego, 3855 Health Sciences Drive, La Jolla, CA 92093-0901, United States; Department of Family Medicine and Public Health, UC San Diego, 9500 Gilman Drive, La Jolla, CA 92093, United States. Electronic address: dstrong@ucsd.edu.'}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Stone', 'Affiliation': 'Department of Family Medicine and Public Health, UC San Diego, 9500 Gilman Drive, La Jolla, CA 92093, United States. Electronic address: m3stone@ucsd.edu.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Villaseñor', 'Affiliation': 'Department of Family Medicine and Public Health, UC San Diego, 9500 Gilman Drive, La Jolla, CA 92093, United States. Electronic address: adriana.villasenor@sdcounty.ca.gov.'}, {'ForeName': 'Claudiu V', 'Initials': 'CV', 'LastName': 'Dimofte', 'Affiliation': 'Department of Marketing, San Diego State University, 5500 Campanile Dr, San Diego, CA 92182, United States. Electronic address: cdimofte@sdsu.edu.'}, {'ForeName': 'Eric C', 'Initials': 'EC', 'LastName': 'Leas', 'Affiliation': 'Cancer Control Program, Moores Cancer Center, UC San Diego, 3855 Health Sciences Drive, La Jolla, CA 92093-0901, United States; Department of Family Medicine and Public Health, UC San Diego, 9500 Gilman Drive, La Jolla, CA 92093, United States. Electronic address: ecleas@ucsd.edu.'}, {'ForeName': 'Jesica', 'Initials': 'J', 'LastName': 'Oratowski', 'Affiliation': 'Department of Family Medicine and Public Health, UC San Diego, 9500 Gilman Drive, La Jolla, CA 92093, United States. Electronic address: joratowski@ucsd.edu.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Brighton', 'Affiliation': 'Department of Family Medicine and Public Health, UC San Diego, 9500 Gilman Drive, La Jolla, CA 92093, United States. Electronic address: ebrighton@ucsd.edu.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Hurst', 'Affiliation': 'Cancer Control Program, Moores Cancer Center, UC San Diego, 3855 Health Sciences Drive, La Jolla, CA 92093-0901, United States. Electronic address: shurst@ucsd.edu.'}, {'ForeName': 'Kimberley', 'Initials': 'K', 'LastName': 'Pulvers', 'Affiliation': 'Department of Psychology, Social and Behavioral Sciences Building, California State University, San Marcos 200 E Barham Dr, San Marcos, CA, 92096, United States. Electronic address: kpulvers@csusm.edu.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Kealey', 'Affiliation': 'Cancer Control Program, Moores Cancer Center, UC San Diego, 3855 Health Sciences Drive, La Jolla, CA 92093-0901, United States.'}, {'ForeName': 'Ruifeng', 'Initials': 'R', 'LastName': 'Chen', 'Affiliation': 'Division of Biostatistics, Department of Family Medicine and Public Health, UC San Diego, 9500 Gilman Drive, La Jolla, CA 92093, United States. Electronic address: ruc075@ucsd.edu.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Messer', 'Affiliation': 'Cancer Control Program, Moores Cancer Center, UC San Diego, 3855 Health Sciences Drive, La Jolla, CA 92093-0901, United States; Division of Biostatistics, Department of Family Medicine and Public Health, UC San Diego, 9500 Gilman Drive, La Jolla, CA 92093, United States. Electronic address: kmesser@ucsd.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106152']
2935,32967799,"A phase 3, double-blind, parallel-group study to evaluate the efficacy and safety of tezacaftor in combination with ivacaftor in participants 6 through 11 years of age with cystic fibrosis homozygous for F508del or heterozygous for the F508del-CFTR mutation and a residual function mutation.","BACKGROUND


The CFTR modulator tezacaftor/ivacaftor was efficacious and generally safe and well tolerated in Phase 3 studies in participants ≥12 years of age with cystic fibrosis (CF) homozygous for the F508del-CFTR mutation or heterozygous with a residual function-CFTR mutation (F/F or F/RF respectively). We evaluated tezacaftor/ivacaftor's efficacy and safety over 8 weeks in participants 6 through 11 years of age with these mutations.
METHODS


Participants were randomized 4:1 to tezacaftor/ivacaftor or a blinding group (placebo for F/F, ivacaftor for F/RF). The primary endpoint was within-group change from baseline in the lung clearance index 2·5 (LCI 2·5 ) through Week 8. Secondary endpoints were change from baseline in sweat chloride (SwCl), cystic fibrosis questionnaire-revised (CFQ-R) respiratory domain score, and safety.
RESULTS


Sixty-seven participants received at least one study drug dose. Of those, 54 received tezacaftor/ivacaftor (F/F, 42; F/RF, 12), 10 placebo, and 3 ivacaftor; 66 completed the study. The within-group change in LCI 2·5  was significantly reduced (improved) by -0·51 (95% CI: -0·74, -0·29). SwCl concentration decreased (improved) by -12·3 mmol/L and CFQ-R respiratory domain score increased (improved, nonsignificantly) by 2·3 points. There were no serious adverse events (AEs) or AEs leading to tezacaftor/ivacaftor discontinuation or interruption. The most common AEs (≥10%) in participants receiving tezacaftor/ivacaftor were cough, headache, and productive cough.
CONCLUSIONS


Tezacaftor/ivacaftor improved lung function (assessed using LCI) and CFTR function (measured by SwCl concentration) in participants 6 through 11 years of age with F/F or F/RF genotypes. Tezacaftor/ivacaftor was safe and well tolerated; no new safety concerns were identified.",2020,There were no serious adverse events (AEs) or AEs leading to tezacaftor/ivacaftor discontinuation or interruption.,"['participants ≥12 years of age with cystic fibrosis (CF) homozygous for the F508del-CFTR mutation or heterozygous with a residual function-CFTR mutation (F/F or F/RF respectively', 'Participants', 'participants 6 through 11 years of age with cystic fibrosis homozygous for F508del or heterozygous for the F508del-CFTR mutation and a residual function mutation', 'participants 6 through 11 years of age with these mutations']","['0·51', 'tezacaftor/ivacaftor', 'ivacaftor', 'Tezacaftor/ivacaftor', 'tezacaftor/ivacaftor or a blinding group (placebo for F/F, ivacaftor for F/RF', 'tezacaftor']","['safe and well tolerated; no new safety concerns', 'lung clearance index 2·5', 'CFQ-R respiratory domain score', 'SwCl concentration', 'efficacy and safety', 'cough, headache, and productive cough', 'LCI 2·5', 'change from baseline in sweat chloride (SwCl), cystic fibrosis questionnaire-revised (CFQ-R) respiratory domain score, and safety', 'lung function (assessed using LCI) and CFTR function', 'serious adverse events (AEs) or AEs leading to tezacaftor/ivacaftor discontinuation or interruption']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}, {'cui': 'C0019904', 'cui_str': 'Homozygote'}, {'cui': 'C0056889', 'cui_str': 'CFTR Protein'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0019425', 'cui_str': 'Heterozygote'}, {'cui': 'C0855766', 'cui_str': 'Residual function'}]","[{'cui': 'C4519194', 'cui_str': 'tezacaftor'}, {'cui': 'C3264621', 'cui_str': 'ivacaftor'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0231990', 'cui_str': 'Lung clearance index'}, {'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0428295', 'cui_str': 'Cystic fibrosis sweat test'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0239134', 'cui_str': 'Productive cough'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0056889', 'cui_str': 'CFTR Protein'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C4519194', 'cui_str': 'tezacaftor'}, {'cui': 'C3264621', 'cui_str': 'ivacaftor'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}]",6.0,0.131127,There were no serious adverse events (AEs) or AEs leading to tezacaftor/ivacaftor discontinuation or interruption.,"[{'ForeName': 'Jane C', 'Initials': 'JC', 'LastName': 'Davies', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, United Kingdom; Royal Brompton & Harefield NHS Foundation Trust, London, United Kingdom. Electronic address: j.c.davies@imperial.ac.uk.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Sermet-Gaudelus', 'Affiliation': 'INSERM U1151, Institut Necker Enfants Malades, Université Paris Sorbonne, Paris, France, Hôpital Necker-Enfants malades, Paris, France.'}, {'ForeName': 'Lutz', 'Initials': 'L', 'LastName': 'Naehrlich', 'Affiliation': 'Department of Pediatrics, Justus Liebig University Giessen, Giessen, Germany; Universities of Giessen and Marburg Lung Center, The German Center for Lung Research, Giessen, Germany.'}, {'ForeName': 'R Scott', 'Initials': 'RS', 'LastName': 'Harris', 'Affiliation': 'Vertex Pharmaceuticals Incorporated, Boston, MA, United States.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Campbell', 'Affiliation': 'Vertex Pharmaceuticals Incorporated, Boston, MA, United States.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Ahluwalia', 'Affiliation': 'Vertex Pharmaceuticals Incorporated, Boston, MA, United States.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Short', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, United Kingdom; Royal Brompton & Harefield NHS Foundation Trust, London, United Kingdom.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Haseltine', 'Affiliation': 'Vertex Pharmaceuticals Incorporated, Boston, MA, United States.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Panorchan', 'Affiliation': 'Vertex Pharmaceuticals Incorporated, Boston, MA, United States.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Saunders', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, United Kingdom; Royal Brompton & Harefield NHS Foundation Trust, London, United Kingdom.'}, {'ForeName': 'Caroline A', 'Initials': 'CA', 'LastName': 'Owen', 'Affiliation': 'Vertex Pharmaceuticals Incorporated, Boston, MA, United States.'}, {'ForeName': 'Claire E', 'Initials': 'CE', 'LastName': 'Wainwright', 'Affiliation': 'The University of Queensland, Brisbane, QLD, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society,['10.1016/j.jcf.2020.07.023']
2936,32968947,"Placebo-Controlled, Double-Blind Study of Empagliflozin (EMPA) and Implantable Cardioverter-Defibrillator (EMPA-ICD) in Patients with Type 2 Diabetes (T2DM): Rationale and Design.","INTRODUCTION


Type 2 diabetes (T2DM) is associated with cardiovascular death, including sudden cardiac death due to arrhythmias. Patients with an implantable cardioverter-defibrillator (ICD) are also at high risk of developing a clinically significant ventricular arrhythmia. It has been reported that sodium-glucose cotransporter 2 (SGLT2) inhibitors can reduce cardiovascular deaths; however, the physiological mechanisms of this remain unclear. It is, however, well known that SGLT2 inhibitors increase blood ketone bodies, which have been suggested to have sympatho-suppressive effects. Empagliflozin (EMPA) is an SGLT2 inhibitor. The current clinical trial titled ""Placebo-controlled, double-blind study of empagliflozin (EMPA) and implantable cardioverter-defibrillator (EMPA-ICD) in patients with type 2 diabetes (T2DM)"" was designed to investigate the antiarrhythmic effects of EMPA.
METHODS


The EMPA-ICD study is a prospective, multicenter, placebo-controlled, double-blind, randomized, investigator-initiated clinical trial currently in progress. A total of 210 patients with T2DM (hemoglobin A1c 6.5-10.0%) will be randomized (1:1) to receive once-daily placebo or EMPA, 10 mg, for 24 weeks. The primary endpoint is the number of clinically significant ventricular arrhythmias for 24 weeks before and 24 weeks after study drug administration, as documented by the ICD. The secondary endpoints of the study are the change from baseline concentrations in blood ketone and catecholamine 24 weeks after drug treatment.
CONCLUSION


The EMPA-ICD study is the first clinical trial to assess the effect of an SGLT2 inhibitor on clinically significant ventricular arrhythmias in patients with T2DM and an ICD.
TRIAL REGISTRATION


Unique trial number, jRCTs031180120 ( https://jrct.niph.go.jp/latest-detail/jRCTs031180120 ).",2020,"The primary endpoint is the number of clinically significant ventricular arrhythmias for 24 weeks before and 24 weeks after study drug administration, as documented by the ICD.","['Patients with Type\xa02 Diabetes (T2DM', 'patients with type\xa02 diabetes (T2DM', '210 patients with T2DM (hemoglobin', 'patients with T2DM and an ICD']","['placebo or EMPA', 'empagliflozin (EMPA) and implantable cardioverter-defibrillator (EMPA-ICD', 'Empagliflozin (EMPA', 'Implantable Cardioverter-Defibrillator (EMPA-ICD', 'placebo', 'implantable cardioverter-defibrillator (ICD', 'Placebo', 'SGLT2 inhibitor']","['number of clinically significant ventricular arrhythmias', 'cardiovascular deaths', 'blood ketone and catecholamine 24\xa0weeks after drug treatment']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0162589', 'cui_str': 'Implantable defibrillator'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0162589', 'cui_str': 'Implantable defibrillator'}, {'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0085612', 'cui_str': 'Ventricular arrhythmia'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022634', 'cui_str': 'Ketone'}, {'cui': 'C0007412', 'cui_str': 'Catecholamine'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",210.0,0.405225,"The primary endpoint is the number of clinically significant ventricular arrhythmias for 24 weeks before and 24 weeks after study drug administration, as documented by the ICD.","[{'ForeName': 'Shinya', 'Initials': 'S', 'LastName': 'Fujiki', 'Affiliation': 'Department of Cardiovascular Biology and Medicine, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan.'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Iijima', 'Affiliation': 'Department of Cardiovascular Biology and Medicine, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan.'}, {'ForeName': 'Masaaki', 'Initials': 'M', 'LastName': 'Okabe', 'Affiliation': 'Department of Cardiology, Tachikawa General Hospital, Nagaoka, Niigata, Japan.'}, {'ForeName': 'Shinichi', 'Initials': 'S', 'LastName': 'Niwano', 'Affiliation': 'Cardiovascular Medicine, Kitasato University, Sagamihara, Kanagawa, Japan.'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Tsujita', 'Affiliation': 'Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan.'}, {'ForeName': 'Shigeto', 'Initials': 'S', 'LastName': 'Naito', 'Affiliation': 'Division of Cardiology, Gunma Prefectural Cardiovascular Center, Maebashi, Gunma, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Ando', 'Affiliation': 'Department of Cardiology, Kokura Memorial Hospital, Kitakyushu, Fukuoka, Japan.'}, {'ForeName': 'Kengo', 'Initials': 'K', 'LastName': 'Kusano', 'Affiliation': 'Department of Cardiovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Osaka, Japan.'}, {'ForeName': 'Ritsushi', 'Initials': 'R', 'LastName': 'Kato', 'Affiliation': 'Department of Cardiology, Saitama Medical University International Medical Center, Hidaka, Saitama, Japan.'}, {'ForeName': 'Junichi', 'Initials': 'J', 'LastName': 'Nitta', 'Affiliation': 'Department of Cardiology, Sakakibara Heart Institute, Fuchu, Tokyo, Japan.'}, {'ForeName': 'Tetsuji', 'Initials': 'T', 'LastName': 'Miura', 'Affiliation': 'Department of Cardiovascular, Renal and Metabolic Medicine, Sapporo Medical University School of Medicine, Sapporo, Hokkaido, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Mitsuhashi', 'Affiliation': 'Department of Cardiology, Jichi Medical University Saitama Medical Center, Saitama, Japan.'}, {'ForeName': 'Kazuomi', 'Initials': 'K', 'LastName': 'Kario', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine, Shimotsuke, Tochigi, Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Kondo', 'Affiliation': 'Department of Cardiovascular Medicine, Chiba University Graduate School of Medicine, Chiba, Japan.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Ieda', 'Affiliation': 'Department of Cardiology, Faculty of Medicine, University of Tsukuba, Tsukuba, Ibaraki, Japan.'}, {'ForeName': 'Nobuhisa', 'Initials': 'N', 'LastName': 'Hagiwara', 'Affiliation': ""Department of Cardiology, Tokyo Women's Medical University, Tokyo, Japan.""}, {'ForeName': 'Toyoaki', 'Initials': 'T', 'LastName': 'Murohara', 'Affiliation': 'Department of Cardiology, Nagoya University Graduate School of Medicine, Nagoya, Aichi, Japan.'}, {'ForeName': 'Kazuyoshi', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'Department of Cardiology, Niigata City General Hospital, Niigata, Japan.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Tomita', 'Affiliation': 'Department of Cardiology and Nephrology, Hirosaki University Graduate School of Medicine, Hirosaki, Aomori, Japan.'}, {'ForeName': 'Yasuchika', 'Initials': 'Y', 'LastName': 'Takeishi', 'Affiliation': 'Department of Cardiovascular Medicine, Fukushima Medical University, Fukushima, Japan.'}, {'ForeName': 'Toshihisa', 'Initials': 'T', 'LastName': 'Anzai', 'Affiliation': 'Department of Cardiovascular Medicine, Hokkaido University Graduate School of Medicine, Sapporo, Hokkaido, Japan.'}, {'ForeName': 'Wataru', 'Initials': 'W', 'LastName': 'Shimizu', 'Affiliation': 'Department of Cardiovascular Medicine, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Watanabe', 'Affiliation': 'Department of Cardiology, Pulmonology, and Nephrology, Yamagata University Faculty of Medicine, Yamagata, Japan.'}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Morino', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Iwate Medical University, Morioka, Iwate, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Kato', 'Affiliation': 'Department of Cardiology, Graduate School of Medical Science, Kanazawa University, Kanazawa, Ishikawa, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Tada', 'Affiliation': 'Department of Cardiovascular Medicine, Faculty of Medical Sciences, University of Fukui, Fukui, Japan.'}, {'ForeName': 'Yoshihisa', 'Initials': 'Y', 'LastName': 'Nakagawa', 'Affiliation': 'Department of Cardiovascular Medicine, Shiga University of Medical Science, Otsu, Shiga, Japan.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Yano', 'Affiliation': 'Division of Cardiology, Department of Medicine and Clinical Science, Yamaguchi University Graduate School of Medicine, Yamaguchi, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Maemura', 'Affiliation': 'Department of Cardiovascular Medicine, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Kimura', 'Affiliation': 'Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine, Kyoto, Japan.'}, {'ForeName': 'Hisako', 'Initials': 'H', 'LastName': 'Yoshida', 'Affiliation': 'Department of Medial Statistics, Osaka City University, Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Keiko', 'Initials': 'K', 'LastName': 'Ota', 'Affiliation': 'Data Management Group, Department of Clinical Research Support, Center for Clinical Research and Innovation, Osaka City University Hospital, Osaka, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Tanaka', 'Affiliation': 'Clinical and Translational Research Center, Niigata University Medical and Dental Hospital, Niigata, Japan.'}, {'ForeName': 'Nobutaka', 'Initials': 'N', 'LastName': 'Kitamura', 'Affiliation': 'Clinical and Translational Research Center, Niigata University Medical and Dental Hospital, Niigata, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Node', 'Affiliation': 'Department of Cardiovascular Medicine, Saga University, Saga, Japan.'}, {'ForeName': 'Yoshifusa', 'Initials': 'Y', 'LastName': 'Aizawa', 'Affiliation': 'Department of Cardiology, Tachikawa General Hospital, Nagaoka, Niigata, Japan.'}, {'ForeName': 'Ippei', 'Initials': 'I', 'LastName': 'Shimizu', 'Affiliation': 'Department of Cardiovascular Biology and Medicine, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Izumi', 'Affiliation': 'Department of Cardiovascular Biology and Medicine, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan.'}, {'ForeName': 'Kazuyuki', 'Initials': 'K', 'LastName': 'Ozaki', 'Affiliation': 'Department of Cardiovascular Biology and Medicine, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan.'}, {'ForeName': 'Tohru', 'Initials': 'T', 'LastName': 'Minamino', 'Affiliation': 'Department of Cardiovascular Biology and Medicine, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan. t.minamino@juntendo.ac.jp.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-020-00924-9']
2937,32969022,Cannabidiol in conjunction with clobazam: analysis of four randomized controlled trials.,"OBJECTIVES


To assess the efficacy and safety profile of add-on cannabidiol (CBD) in patients with Lennox-Gastaut syndrome (LGS) and Dravet syndrome (DS) on clobazam and in the overall population of four randomized, controlled phase 3 trials.
METHODS


Patients received plant-derived, highly purified CBD medicine (Epidiolex ®  in the USA; Epidyolex ®  in Europe; 100 mg/ml oral solution) at a dose of 10 or 20 mg/kg/day, or placebo for 14 weeks. A subgroup analysis of patients on clobazam and meta-analysis by syndrome were conducted. The primary endpoint was percentage reduction in primary seizure type during the treatment period.
RESULTS


396 patients with LGS (49% on clobazam) and 318 patients with DS (64% on clobazam) were included. CBD treatment resulted in a reduction in primary seizure frequency vs placebo in the overall population (treatment ratio [95% confidence interval]: LGS, 0.70 [0.62-0.80]; DS, 0.71 [0.60-0.83]) and in patients receiving clobazam (LGS, 0.56 [0.47-0.67]; DS, 0.63 [0.52-0.77]). The antiseizure efficacy of CBD was also demonstrated across other endpoints vs placebo (≥50% responder rate, total seizure frequency, number of seizure-free days, and Subject/Caregiver Global Impression of Change scores) in the overall populations and in patients receiving clobazam. There were higher incidences of somnolence and sedation in patients on CBD and clobazam. Most incidences of elevated transaminases occurred in patients on concomitant valproate and, to a lesser extent, clobazam.
CONCLUSIONS


Add-on CBD was effective in reducing seizures in the overall populations and in conjunction with clobazam. Somnolence and sedation occurred more frequently in patients on CBD and clobazam.",2020,CBD treatment resulted in a reduction in primary seizure frequency vs placebo in the overall population (treatment ratio [95% confidence interval]:,"['396 patients with LGS (49% on', 'patients with Lennox-Gastaut syndrome (LGS) and Dravet syndrome (DS) on', '318 patients with DS (64% on', 'Patients received']","['CBD', 'plant-derived, highly purified CBD medicine (Epidiolex ®  in US; Epidyolex ®  in Europe; 100\xa0mg/mL oral solution', 'cannabidiol (CBD', 'placebo', 'clobazam']","['elevated transaminases', 'primary seizure frequency', 'somnolence and sedation', 'percentage reduction in primary seizure type', 'total seizure frequency, number of seizure-free days, and Subject/Caregiver Global Impression of Change scores', 'antiseizure efficacy of CBD', 'Somnolence and sedation']","[{'cui': 'C5191354', 'cui_str': '396'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0238111', 'cui_str': 'Lennox-Gastaut syndrome'}, {'cui': 'C0751122', 'cui_str': 'Severe myoclonic epilepsy in infancy'}]","[{'cui': 'C0006863', 'cui_str': 'Cannabidiol'}, {'cui': 'C0032098', 'cui_str': 'Kingdom Viridiplantae'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C4731581', 'cui_str': 'Epidiolex'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439294', 'cui_str': 'g/L'}, {'cui': 'C0991536', 'cui_str': 'Oral solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0055891', 'cui_str': 'clobazam'}]","[{'cui': 'C0438717', 'cui_str': 'Transaminases increased'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0149775', 'cui_str': 'Fit frequency'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1299590', 'cui_str': 'Seizure free'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0006863', 'cui_str': 'Cannabidiol'}]",396.0,0.31064,CBD treatment resulted in a reduction in primary seizure frequency vs placebo in the overall population (treatment ratio [95% confidence interval]:,"[{'ForeName': 'Boudewijn', 'Initials': 'B', 'LastName': 'Gunning', 'Affiliation': 'Stichting Epilepsie Instellingen Nederland, Zwolle, The Netherlands.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Mazurkiewicz-Bełdzińska', 'Affiliation': 'Medical University of Gdańsk, Gdańsk, Poland.'}, {'ForeName': 'Richard F M', 'Initials': 'RFM', 'LastName': 'Chin', 'Affiliation': 'Royal Hospital for Sick Children, Edinburgh, UK.'}, {'ForeName': 'Hari', 'Initials': 'H', 'LastName': 'Bhathal', 'Affiliation': 'Centro Médico Teknon, Neurocenter Barcelona, Barcelona, Spain.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Nortvedt', 'Affiliation': 'GW Research Ltd, Cambridge, UK.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Dunayevich', 'Affiliation': 'Greenwich Biosciences, Inc, Carlsbad, CA, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Checketts', 'Affiliation': 'GW Research Ltd, Cambridge, UK.'}]",Acta neurologica Scandinavica,['10.1111/ane.13351']
2938,32975679,"Effect of Empagliflozin on Liver Steatosis and Fibrosis in Patients With Non-Alcoholic Fatty Liver Disease Without Diabetes: A Randomized, Double-Blind, Placebo-Controlled Trial.","INTRODUCTION


Despite the high prevalence of non-alcoholic fatty liver disease (NAFLD) and its associated co-morbidities, no efficient treatment in a high percentage of individuals is available. Beneficial effects of sodium-glucose co-transporter 2 inhibitors on fatty liver have been investigated in people with type 2 diabetes (T2DM). The aim of this study was to explore the effect of empagliflozin on liver steatosis and fibrosis in patients with NAFLD without T2DM.
METHODS


In this prospective randomized, double-blind, placebo-controlled clinical trial, participants with NAFLD were randomized to empagliflozin (10 mg/day) (n = 43) or placebo (n = 47) for 24 weeks. Hepatic steatosis and fibrosis were assessed using transient elastography to measure the controlled attenuation parameter (CAP) and liver stiffness measurement (LSM). The primary outcome was the change in CAP score at 24 weeks.
RESULTS


There was significant decrease in CAP score in both groups but no significant difference was observed between the two groups (P = 0.396). LSM was significantly decreased in the empagliflozin-treated group (6.03 ± 1.40 to 5.33 ± 1.08 kPa; P = 0.001), while no change was found in the placebo group. In subgroups analysis of patients with significant steatosis at baseline (CAP ≥ 302 dB/m), steatosis significantly improved in the empagliflozin group (37.2% vs. 17%; P = 0.035). There was a significant decrease in the grade of liver fat on visual analysis of ultrasound images, AST, ALT, and fasting insulin levels in the empagliflozin group, while no changes were observed in the placebo group.
CONCLUSIONS


Empagliflozin improves liver steatosis and, more importantly, measures of liver fibrosis in patients with NAFLD without T2DM.
TRIAL REGISTRATION


ClinicalTrials.gov identifier, IRCT20190122042450N1.",2020,"There was a significant decrease in the grade of liver fat on visual analysis of ultrasound images, AST, ALT, and fasting insulin levels in the empagliflozin group, while no changes were observed in the placebo group.
","['people with type\xa02 diabetes (T2DM', 'Without Diabetes', 'participants with NAFLD', '302\xa0dB/m', 'Patients With Non-Alcoholic Fatty Liver Disease', 'patients with NAFLD without T2DM', 'patients with significant steatosis at baseline (CAP\u2009≥']","['empagliflozin', 'placebo', 'sodium-glucose co-transporter\xa02 inhibitors', 'Empagliflozin', 'Placebo']","['change in CAP score', 'controlled attenuation parameter (CAP) and liver stiffness measurement (LSM', 'Hepatic steatosis and fibrosis', 'grade of liver fat on visual analysis of ultrasound images, AST, ALT, and fasting insulin levels', 'Liver Steatosis and Fibrosis', 'LSM', 'liver fibrosis', 'liver steatosis and fibrosis', 'liver steatosis', 'CAP score']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0152254', 'cui_str': 'Fatty degeneration'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]","[{'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4301634', 'cui_str': 'Sodium-glucose co-transporter 2 (SGLT2) inhibitors'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0015695', 'cui_str': 'Fatty Liver'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement'}, {'cui': 'C0239946', 'cui_str': 'Hepatic fibrosis'}]",,0.63044,"There was a significant decrease in the grade of liver fat on visual analysis of ultrasound images, AST, ALT, and fasting insulin levels in the empagliflozin group, while no changes were observed in the placebo group.
","[{'ForeName': 'Hoda', 'Initials': 'H', 'LastName': 'Taheri', 'Affiliation': 'Endocrine Research Center, Institute of Endocrinology and Metabolism, Iran University of Medical Sciences (IUMS), Tehran, Iran.'}, {'ForeName': 'Mojtaba', 'Initials': 'M', 'LastName': 'Malek', 'Affiliation': 'Research Center for Prevention of Cardiovascular Disease, Institute of Endocrinology and Metabolism, Iran University of Medical Sciences (IUMS), Tehran, Iran. malek.m@iums.ac.ir.'}, {'ForeName': 'Faramarz', 'Initials': 'F', 'LastName': 'Ismail-Beigi', 'Affiliation': 'Department of Medicine, Case Western Reserve University, University Hospitals Cleveland Medical Center, Cleveland, OH, 44106, USA.'}, {'ForeName': 'Farhad', 'Initials': 'F', 'LastName': 'Zamani', 'Affiliation': 'Gastrointestinal and Liver Disease Research Center, Iran University of Medical Sciences (IUMS), Tehran, Iran.'}, {'ForeName': 'Masoudreza', 'Initials': 'M', 'LastName': 'Sohrabi', 'Affiliation': 'Gastrointestinal and Liver Disease Research Center, Iran University of Medical Sciences (IUMS), Tehran, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Reza Babaei', 'Affiliation': 'Department of Interventional Radiology, Firouzgar Hospital, Iran University of Medical Sciences (IUMS), Tehran, Iran.'}, {'ForeName': 'Mohammad E', 'Initials': 'ME', 'LastName': 'Khamseh', 'Affiliation': 'Endocrine Research Center, Institute of Endocrinology and Metabolism, Iran University of Medical Sciences (IUMS), Tehran, Iran.'}]",Advances in therapy,['10.1007/s12325-020-01498-5']
2939,32971036,Molecular response after obinutuzumab plus high-dose cytarabine induction for transplant-eligible patients with untreated mantle cell lymphoma (LyMa-101): a phase 2 trial of the LYSA group.,"BACKGROUND


Obinutuzumab monotherapy has shown promising efficacy in mantle cell lymphoma. We aimed to investigate the activity of obinutuzumab plus DHAP (dexamethasone, high-dose cytarabine, and cisplatin), measured by minimal residual disease quantitative (q)PCR status in the bone marrow after four cycles.
METHODS


LyMa-101 was a prospective, open-label, single-arm, phase 2 trial. Participants were enrolled from 28 hospitals in France. Newly diagnosed patients with mantle cell lymphoma (aged 18 to <66 years) who were eligible for autologous stem-cell transplantation received four cycles of obinutuzumab plus DHAP (obinutuzumab 1000 mg/m 2  intravenously on days 1, 8, and 15 at cycle 1 and day 1 at cycles 2, 3, and 4; dexamethasone 40 mg intravenously on days 1-4, cytarabine 2 g/m 2  intravenously every 12 h on day 1, and according to local investigator, cisplatin 100 mg/m 2  by continuous infusion over 24 h on day 1 or carboplatin area under the curve 5 or oxaliplatin 130 mg/m 2 ) every 21 days before transplantation, and 3 years of obinutuzumab (1000 mg/m 2  every 2 months) maintenance followed by minimal residual disease-based obinutuzumab on-demand maintenance. The primary outcome was minimal residual disease negativity in the bone marrow after four cycles of obinutuzumab plus DHAP at the end of induction, measured in the efficacy set (all minimal residual disease-informative [bone marrow or peripheral blood] patients who received at least one dose of obinutuzumab). Obinutuzumab plus DHAP was considered effective if bone marrow minimal residual disease negativity was 70% or more by intention to treat. The trial is closed to recruitment and registered with ClinicalTrials.gov, NCT02896582.
FINDINGS


86 patients were enrolled between Nov 29, 2016, and May 2, 2018. 81 patients completed induction, 73 underwent autologous stem-cell transplantation, and 69 started maintenance therapy. 55 (75%) of 73 patients in the efficacy set reached minimal residual disease negativity in bone marrow at end of induction. According to the protocol definition, 18 (25%) of 73 patients in the efficacy set were minimal residual disease-positive: 12 patients who were minimal residual disease-positive in the bone marrow, plus two patients who progressed during induction, and four patients who did not have minimal residual disease assessment. The most common grade 3-4 treatment-emergent adverse events were anaemia (grade 3, 26 [31%] of 85 patients; grade 4, three [4%] of 85 patients) and neutropenia (grade 3, 13 [15%] of 85 patients; grade 4, 32 [38%] of 85 patients). 58 serious adverse events occurred during the induction phase. There were no treatment-related deaths.
INTERPRETATION


Obinutuzumab plus DHAP is a well tolerated regimen and has good activity for inducing minimal residual disease negativity in the bone marrow of transplant-eligible patients with mantle cell lymphoma. Obinutuzumab plus DHAP has potential activity as induction chemotherapy, with bone marrow minimal residual disease negativity potentially predicting long-term disease control.
FUNDING


Roche SAS.",2020,"There were no treatment-related deaths.
","['transplant-eligible patients with untreated mantle cell lymphoma (LyMa-101', 'Newly diagnosed patients with mantle cell lymphoma (aged 18 to <66 years) who were eligible for autologous stem-cell transplantation received four cycles of', '86 patients were enrolled between Nov 29, 2016, and May 2, 2018', '81 patients completed induction, 73 underwent autologous stem-cell transplantation, and 69 started maintenance therapy', 'transplant-eligible patients with mantle cell lymphoma', '73 patients in the efficacy set were minimal residual disease-positive: 12 patients who were minimal residual disease-positive in the bone marrow, plus two patients who progressed during induction, and four patients who did not have minimal residual disease assessment', 'Participants were enrolled from 28 hospitals in France']","['obinutuzumab plus DHAP (obinutuzumab 1000 mg/m 2  intravenously', 'obinutuzumab plus high-dose cytarabine induction', 'obinutuzumab (1000 mg/m 2  every 2 months) maintenance followed by minimal residual disease-based obinutuzumab on-demand maintenance', 'LYSA', 'Obinutuzumab plus DHAP', 'obinutuzumab plus DHAP (dexamethasone, high-dose cytarabine, and cisplatin', 'cisplatin 100 mg/m 2  by continuous infusion over 24 h on day 1 or carboplatin area under the curve 5 or oxaliplatin', 'dexamethasone 40 mg intravenously on days 1-4, cytarabine']","['58 serious adverse events', 'Molecular response', 'neutropenia', 'minimal residual disease negativity in the bone marrow']","[{'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0334634', 'cui_str': 'Mantle cell lymphoma'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1831743', 'cui_str': 'Transplantation of autologous hematopoietic stem cell'}, {'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0242596', 'cui_str': 'Minimal residual disease'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0016674', 'cui_str': 'France'}]","[{'cui': 'C2742503', 'cui_str': 'obinutuzumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0012324', 'cui_str': 'Dihydroxyacetone 3-Phosphate'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0242596', 'cui_str': 'Minimal residual disease'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0444889', 'cui_str': 'Continuous infusion'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0242596', 'cui_str': 'Minimal residual disease'}, {'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}]",86.0,0.0468988,"There were no treatment-related deaths.
","[{'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Le Gouill', 'Affiliation': ""Service d'hématologie clinique, CHU de Nantes, INSERM CRCINA Nantes-Angers, NeXT Université de Nantes, Nantes, France. Electronic address: steven.legouill@chu-nantes.fr.""}, {'ForeName': 'Asma', 'Initials': 'A', 'LastName': 'Beldi-Ferchiou', 'Affiliation': 'Biological Haematology and Immunology Department, Groupe Hospitalier Mondor, Assistance Publique Hôpitaux de Paris, INSERM U955, Paris, France.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Alcantara', 'Affiliation': 'Onco-Haematology, Université de Paris, Hôpital and Institut Necker-Enfants Malades, Assistance-Publique-Hôpitaux de Paris, INSERM U1151, Paris, France.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Cacheux', 'Affiliation': ""Service d'hématologie clinique du CHU de Clermont-Ferrand, Clermont-Ferrand, France.""}, {'ForeName': 'Violaine', 'Initials': 'V', 'LastName': 'Safar', 'Affiliation': 'Centre Hospitalier Lyon Sud, Hospices Civils de Lyon, Lyon, France.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Burroni', 'Affiliation': 'Department of Pathology, Cochin Hospital, Paris, France.'}, {'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'Guidez', 'Affiliation': ""Service d'hématologie clinique du CHU de Poitiers, Poitiers, France.""}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Gastinne', 'Affiliation': ""Service d'hématologie clinique, CHU de Nantes, INSERM CRCINA Nantes-Angers, NeXT Université de Nantes, Nantes, France.""}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Canioni', 'Affiliation': 'Onco-Haematology, Université de Paris, Hôpital and Institut Necker-Enfants Malades, Assistance-Publique-Hôpitaux de Paris, INSERM U1151, Paris, France.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Thieblemont', 'Affiliation': ""Service d'hémato-oncologie, L'hôpital Saint-Louis AP-HP, Université de Paris, Paris, France.""}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Maisonneuve', 'Affiliation': 'CHD de Vendée, La Roche-Sur-Yon, France.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Bodet-Milin', 'Affiliation': 'Service de médecine nucléaire, CHU de Nantes, INSERM CRCINA Nantes-Angers, NeXT Université de Nantes, Nantes, France.'}, {'ForeName': 'Roch', 'Initials': 'R', 'LastName': 'Houot', 'Affiliation': ""Service d'Hématologie Clinique, CHU de Rennes, Université de Rennes, INSERM U1236, Rennes, France.""}, {'ForeName': 'Lucie', 'Initials': 'L', 'LastName': 'Oberic', 'Affiliation': ""Service d'hématologie, IUC Toulouse Oncopole, Toulouse, France.""}, {'ForeName': 'Krimo', 'Initials': 'K', 'LastName': 'Bouabdallah', 'Affiliation': ""Service d'Hématologie, CHU Bordeaux, Bordeaux, France.""}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Bescond', 'Affiliation': ""Service d'Hématologie, CHU Angers, Angers, France.""}, {'ForeName': 'Ghandi', 'Initials': 'G', 'LastName': 'Damaj', 'Affiliation': 'Haematology Institute, Normandy University School of Medicine, Caen, France.'}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Jaccard', 'Affiliation': 'CHU de Limoges, Limoges, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Daguindau', 'Affiliation': 'Centre Hospitalier Annecy-Genevois, Epagny Metz-Tessy, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Moreau', 'Affiliation': ""Service d'anatomo-pathologie, CHU de Nantes, INSERM CRCINA Nantes-Angers, NeXT Université de Nantes, Nantes, France.""}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Tilly', 'Affiliation': ""Département d'Hématologie and U1245, Centre Henri Becquerel, Université de Rouen, Rouen, France.""}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Ribrag', 'Affiliation': ""Département des Innovations Thérapeutiques et Essais Précoces, Université Paris-Saclay, Département d'Hématologie, Gustave Roussy, Université Paris-Saclay, Paris, France.""}, {'ForeName': 'Marie-Hélène', 'Initials': 'MH', 'LastName': 'Delfau-Larue', 'Affiliation': 'Biological Haematology and Immunology Department, Groupe Hospitalier Mondor, Assistance Publique Hôpitaux de Paris, INSERM U955, Paris, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Hermine', 'Affiliation': 'Department of Adult Haematology, Université de Paris, Hôpital Necker-Enfants Malades, Assistance-Publique, Hôpitaux de Paris, Imagine Institute, INSERM U1153, Paris, France.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Macintyre', 'Affiliation': 'Onco-Haematology, Université de Paris, Hôpital and Institut Necker-Enfants Malades, Assistance-Publique-Hôpitaux de Paris, INSERM U1151, Paris, France.'}]",The Lancet. Haematology,['10.1016/S2352-3026(20)30291-X']
2940,32971040,Effects of once-weekly subcutaneous semaglutide on kidney function and safety in patients with type 2 diabetes: a post-hoc analysis of the SUSTAIN 1-7 randomised controlled trials.,"BACKGROUND


Patients with type 2 diabetes have a high risk of developing chronic kidney disease. We examined the effects of semaglutide on kidney function and safety in a large, broad type 2 diabetes population.
METHODS


We did a post-hoc analysis of 8416 patients with type 2 diabetes enrolled in the SUSTAIN 1-5 and SUSTAIN 7 randomised controlled trials, and the SUSTAIN 6 cardiovascular outcomes trial, to examine the effects of once-weekly subcutaneous semaglutide 0·5 mg and 1·0 mg versus comparators (active treatments or placebo) on estimated glomerular filtration rate (eGFR), urinary albumin-to-creatinine ratio (UACR), and kidney adverse events. Data from SUSTAIN 1-5 and SUSTAIN 7 were pooled. eGFR and UACR were also analysed by kidney function and albuminuria status.
FINDINGS


In SUSTAIN 1-5 and SUSTAIN 7, eGFR decreased from baseline to week 12 with all active treatments; estimated treatment differences (ETDs) versus placebo were -2·15 (95% CI -3·47 to -0·83) mL/min per 1·73 m 2  with semaglutide 0·5 mg and -3·00 (-4·31 to -1·68) mL/min per 1·73 m 2  with semaglutide 1·0 mg; after week 12, eGFR plateaued. In SUSTAIN 1-5 and SUSTAIN 7, from baseline to end of treatment the decline in eGFR was greater with semaglutide than with placebo (ETD -1·58 [95% CI -2·92 to -0·25] mL/min per 1·73 m 2  with semaglutide 0·5 mg and -2·02 [-3·35 to -0·68] mL/min per 1·73 m 2  with semaglutide 1·0 mg). In SUSTAIN 6, the decline in eGFR was greater with semaglutide than with placebo from baseline to week 16 (ETD -1·29 [95% CI -2·07 to -0·51] mL/min per 1·73 m 2  with semaglutide 0·5 mg and -1·56 [-2·33 to -0·78] mL/min per 1·73 m 2  with semaglutide 1·0 mg), but not from week 16 to week 104 (1·29 [0·30 to 2·28] mL/min per 1·73 m 2  with semaglutide 0·5 mg and 2·44 [1·45 to 3·44] mL/min per 1·73 m 2  with semaglutide 1·0 mg). Overall (ie, from baseline to week 104), the eGFR decline in SUSTAIN 6 was similar between semaglutide and placebo (ETD 0·07 [95% CI -0·92 to 1·07] mL/min per 1·73 m 2  with semaglutide 0·5 mg and 0·97 [-0·03 to 1·97] mL/min per 1·73 m 2  with semaglutide 1·0 mg). In SUSTAIN 1-5, UACR ratios at end of treatment to baseline were 0·917 with semaglutide 0·5 mg, 0·836 with semaglutide 1·0 mg, and 1·239 with placebo; at end of treatment, greater reductions in UACR were observed with semaglutide versus placebo (estimated treatment ratios 0·74 [95% CI 0·64 to 0·85] for semaglutide 0·5 mg and 0·68 [0·59 to 0·78] for semaglutide 1·0 mg). In SUSTAIN 6, UACR ratios at end of treatment (week 104) to baseline were 0·973 with semaglutide 0·5 mg, 0·858 with semaglutide 1·0 mg, and 1·302 with placebo; at week 104, greater reductions in UACR were observed with semaglutide versus placebo (estimated treatment ratios 0·75 [95% CI 0·66 to 0·85] for semaglutide 0·5 mg and 0·66 [0·58 to 0·75] for semaglutide 1·0 mg). In SUSTAIN 1-7, eGFR initially declined in patients with normal kidney function (and in those with mild kidney impairment with semaglutide 1·0 mg in SUSTAIN 6), but overall (ie, by week 30 for SUSTAIN 1-5 and SUSTAIN 7, and week 104 for SUSTAIN 6), eGFR did not differ between semaglutide and placebo. In SUSTAIN 1-6, UACR decreased in patients with pre-existing microalbuminuria or macroalbuminuria at baseline; it did not change or increased in those with normoalbuminuria at baseline. Kidney adverse events were balanced between treatment groups.
INTERPRETATION


Across the SUSTAIN 1-7 trials, semaglutide was associated with initial reductions in eGFR that plateaued, and marked reductions in UACR. This post-hoc analysis suggests no increase in the risk of kidney adverse events with semaglutide versus the active comparators used across SUSTAIN 1-7.
FUNDING


Novo Nordisk.",2020,"In SUSTAIN 1-5 and SUSTAIN 7, from baseline to end of treatment the decline in eGFR was greater with semaglutide than with placebo (ETD -1·58","['Patients with type 2 diabetes', 'patients with type 2 diabetes', '8416 patients with type 2 diabetes enrolled in the SUSTAIN 1-5']","['semaglutide', '0·5 mg and -3·00 ', '0·25', 'once-weekly subcutaneous semaglutide 0·5', 'once-weekly subcutaneous semaglutide', 'placebo (ETD -1·58', '4·31 to -1·68', '1·56', ' mL/min per 1·73 m 2  with semaglutide 0·5', 'placebo', 'semaglutide 0·5 mg and -2·02', '0·51] mL/min per 1·73 m 2  with semaglutide 0·5', '2·33 to -0·78', 'mg and 1·0 mg versus comparators (active treatments or placebo']","['eGFR and UACR', 'kidney function and albuminuria status', 'decline in eGFR', 'UACR ratios', 'kidney function and safety', 'eGFR decline', 'UACR', 'eGFR', 'risk of kidney adverse events', 'Kidney adverse events', 'estimated glomerular filtration rate (eGFR), urinary albumin-to-creatinine ratio (UACR), and kidney adverse events', 'normal kidney function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}]","[{'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C0558293', 'cui_str': 'Once a week'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0232804', 'cui_str': 'Renal function'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205307', 'cui_str': 'Normal'}]",8416.0,0.16795,"In SUSTAIN 1-5 and SUSTAIN 7, from baseline to end of treatment the decline in eGFR was greater with semaglutide than with placebo (ETD -1·58","[{'ForeName': 'Johannes F E', 'Initials': 'JFE', 'LastName': 'Mann', 'Affiliation': 'KfH Kidney Center, Munich, Germany; Friedrich Alexander University of Erlangen-Nürnberg, Erlangen, Germany. Electronic address: johannes.mann@kms.mhn.de.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hansen', 'Affiliation': 'Novo Nordisk, Søborg, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Idorn', 'Affiliation': 'Novo Nordisk, Søborg, Denmark.'}, {'ForeName': 'Lawrence A', 'Initials': 'LA', 'LastName': 'Leiter', 'Affiliation': ""Li Ka Shing Knowledge Institute, St Michael's Hospital, University of Toronto, Toronto, ON, Canada.""}, {'ForeName': 'Steven P', 'Initials': 'SP', 'LastName': 'Marso', 'Affiliation': 'HCA Midwest Heart and Vascular Institute, Overland Park, Overland Park, KS, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Rossing', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark; Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Seufert', 'Affiliation': 'Division of Endocrinology and Diabetology, Department of Medicine II, Medical Center -Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Sayeh', 'Initials': 'S', 'LastName': 'Tadayon', 'Affiliation': 'Novo Nordisk, Søborg, Denmark.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Vilsbøll', 'Affiliation': 'Steno Diabetes Center Copenhagen, University of Copenhagen, Hellerup, Denmark.'}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(20)30313-2']
2941,32975835,Pharmacokinetics and Pharmacodynamics of Lysergic Acid Diethylamide Microdoses in Healthy Participants.,"""Microdoses"" of lysergic acid diethylamide (LSD) are used recreationally to enhance mood and cognition. Increasing interest has also been seen in developing LSD into a medication. Therefore, we performed a pharmacokinetic-pharmacodynamic study using very low doses of LSD. Single doses of LSD base (5, 10, and 20 µg) and placebo were administered in a double-blind, randomized, placebo-controlled crossover study in 23 healthy participants. Test days were separated by at least 5 days. Plasma levels of LSD and subjective effects were assessed up to 6 hours after administration. Pharmacokinetic parameters were determined using compartmental modeling. Concentration-subjective effect relationships were described using pharmacokinetic-pharmacodynamic modeling. Mean (95% confidence interval) maximal LSD concentrations were 151 pg/mL (127-181), 279 pg/mL (243-320), and 500 pg/mL (413-607) after 5, 10, and 20 µg LSD administration, respectively. Maximal concentrations were reached after 1.1 hours. The mean elimination half-life was 2.7 hours (1.5-6.2). The 5 µg dose of LSD elicited no significant acute subjective effects. The 10 µg dose of LSD significantly increased ratings of ""under the influence"" and ""good drug effect"" compared with placebo. These effects began an average of 1.1 hours after 10 µg LSD administration, peaked at 2.5 hours, and ended at 5.1 hours. The 20 µg dose of LSD significantly increased ratings of ""under the influence,"" ""good drug effects,"" and ""bad drug effects."" LSD concentrations dose-proportionally increased at doses as low as 5-20 µg and decreased with a half-life of 3 hours. The threshold dose of LSD base for psychotropic effects was 10 µg.",2020,"The 10 µg dose of LSD significantly increased ratings of ""under the influence"" and ""good drug effect"" compared with placebo.","['23 healthy participants', 'healthy participants']","['lysergic acid diethylamide microdoses', 'placebo', 'lysergic acid diethylamide (LSD', 'LSD']","['Plasma levels of LSD and subjective effects', 'ratings of ""under the influence,"" ""good drug effects,"" and ""bad drug effects', 'mean elimination half-life', 'maximal LSD concentrations', 'acute subjective effects', 'Maximal concentrations', 'ratings of ""under the influence"" and ""good drug effect', 'LSD concentrations dose']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0024334', 'cui_str': 'Lysergic acid diethylamide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0024334', 'cui_str': 'Lysergic acid diethylamide'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0728866', 'cui_str': 'drug effects'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0018517', 'cui_str': 'Halflife'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]",23.0,0.317833,"The 10 µg dose of LSD significantly increased ratings of ""under the influence"" and ""good drug effect"" compared with placebo.","[{'ForeName': 'Friederike', 'Initials': 'F', 'LastName': 'Holze', 'Affiliation': 'Division of Clinical Pharmacology and Toxicology, Department of Biomedicine and Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Matthias E', 'Initials': 'ME', 'LastName': 'Liechti', 'Affiliation': 'Division of Clinical Pharmacology and Toxicology, Department of Biomedicine and Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Nadia R P W', 'Initials': 'NRPW', 'LastName': 'Hutten', 'Affiliation': 'Department of Neuropsychology & Psychopharmacology, Faculty of Psychology & Neuroscience, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Natasha L', 'Initials': 'NL', 'LastName': 'Mason', 'Affiliation': 'Department of Neuropsychology & Psychopharmacology, Faculty of Psychology & Neuroscience, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Patrick C', 'Initials': 'PC', 'LastName': 'Dolder', 'Affiliation': 'Department of Neuropsychology & Psychopharmacology, Faculty of Psychology & Neuroscience, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Eef L', 'Initials': 'EL', 'LastName': 'Theunissen', 'Affiliation': 'Department of Neuropsychology & Psychopharmacology, Faculty of Psychology & Neuroscience, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Urs', 'Initials': 'U', 'LastName': 'Duthaler', 'Affiliation': 'Division of Clinical Pharmacology and Toxicology, Department of Biomedicine and Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Feilding', 'Affiliation': 'The Beckley Foundation, Oxford, UK.'}, {'ForeName': 'Johannes G', 'Initials': 'JG', 'LastName': 'Ramaekers', 'Affiliation': 'Department of Neuropsychology & Psychopharmacology, Faculty of Psychology & Neuroscience, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Kim P C', 'Initials': 'KPC', 'LastName': 'Kuypers', 'Affiliation': 'Department of Neuropsychology & Psychopharmacology, Faculty of Psychology & Neuroscience, Maastricht University, Maastricht, The Netherlands.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.2057']
2942,32970697,"Acceptability of a trial of vaginal progesterone for the prevention of preterm birth among HIV-infected women in Lusaka, Zambia: A mixed methods study.","Antenatal progesterone prevents preterm birth (PTB) in women with a short cervix or prior PTB in daily vaginal or weekly injectable formulations, respectively. Neither has been tested for the indication of maternal HIV, which is associated with an elevated risk of PTB. The Vaginal Progesterone (VP) Trial was a pilot feasibility study of VP to prevent HIV-related PTB in Lusaka, Zambia. Using mixed methods, we concurrently evaluated the acceptability of the trial and the study product among participants. Over a 1-year period, we enrolled 140 pregnant women living with HIV into a double-masked, placebo-controlled, randomized trial of daily self-administered VP or placebo. We administered an endline questionnaire to all participants and conducted in-depth interviews with 30 participants to assess barriers and facilitators to uptake and retention in the trial and to study product adherence. All interviews were audiotaped, transcribed, translated into English as needed, and independently coded by two analysts to capture emerging themes. Of 131 participants who completed the questionnaire, 128 (98%) reported that nothing was difficult when asked the hardest part about using the study product. When given a hypothetical choice between vaginal and injectable progesterone, 97 (74%) chose vaginal, 31 (24%) injectable, and 3 (2%) stated no preference. Most interviewees reported no difficulties with using the study product; others cited minor side effects and surmountable challenges. Strategies that supported adherence included setting alarms, aligning dosing with antiretrovirals, receiving encouragement from friends and family, sensing a benefit to their unborn baby, and positive feedback from study staff. Participants who reported preference of a vaginal medication over injectable described familiarity with the vaginal product, a fear of needles and resulting pain, and inconvenience of a weekly clinic visit. Those who would prefer weekly injections cited fewer doses to remember. Perceived barriers to study participation included mistrust about the motivations behind research, suspicion of Satanism, and futility or possible harm from a placebo. We report key influences on acceptability of a randomized trial of VP to prevent PTB among HIV-infected women in Zambia, which should inform methods to promote uptake, adherence, and retention in a full-scale trial.",2020,"Of 131 participants who completed the questionnaire, 128 (98%) reported that nothing was difficult when asked the hardest part about using the study product.","['women with a short cervix or prior PTB in daily vaginal or weekly injectable formulations, respectively', '140 pregnant women living with HIV into a double-masked', 'preterm birth among HIV-infected women in Lusaka, Zambia', '131 participants who completed the questionnaire, 128 (98%) reported that nothing was difficult when asked the hardest part about using the study product', 'Participants who reported preference of a vaginal medication over injectable described familiarity with the vaginal product, a fear of needles and resulting pain, and inconvenience of a weekly clinic visit', 'HIV-infected women in Zambia']","['vaginal progesterone', 'Antenatal progesterone', 'placebo', 'VP', 'daily self-administered VP or placebo']",['preterm birth (PTB'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0007874', 'cui_str': 'Cervix uteri structure'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0043445', 'cui_str': 'Zambia'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0332218', 'cui_str': 'Difficult'}, {'cui': 'C1172410', 'cui_str': 'ASK protein, human'}, {'cui': 'C0018599', 'cui_str': 'Hard'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0600269', 'cui_str': 'Familiarity'}, {'cui': 'C3205661', 'cui_str': 'Vaginal Product'}, {'cui': 'C0424187', 'cui_str': 'Fear of needles'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}]","[{'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}]",140.0,0.29868,"Of 131 participants who completed the questionnaire, 128 (98%) reported that nothing was difficult when asked the hardest part about using the study product.","[{'ForeName': 'Joan T', 'Initials': 'JT', 'LastName': 'Price', 'Affiliation': ""Division of Global Women's Health, Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States of America.""}, {'ForeName': 'Chileshe M', 'Initials': 'CM', 'LastName': 'Mabula-Bwalya', 'Affiliation': 'UNC Global Projects - Zambia, Lusaka, Zambia.'}, {'ForeName': 'Bethany L', 'Initials': 'BL', 'LastName': 'Freeman', 'Affiliation': ""Division of Global Women's Health, Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States of America.""}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Carda-Auten', 'Affiliation': 'Department of Health Behavior, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States of America.'}, {'ForeName': 'Winifreda M', 'Initials': 'WM', 'LastName': 'Phiri', 'Affiliation': 'UNC Global Projects - Zambia, Lusaka, Zambia.'}, {'ForeName': 'Kasapo', 'Initials': 'K', 'LastName': 'Chibwe', 'Affiliation': 'UNC Global Projects - Zambia, Lusaka, Zambia.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Kantumoya', 'Affiliation': 'UNC Global Projects - Zambia, Lusaka, Zambia.'}, {'ForeName': 'Bellington', 'Initials': 'B', 'LastName': 'Vwalika', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of Zambia School of Medicine, Lusaka, Zambia.'}, {'ForeName': 'Jeffrey S A', 'Initials': 'JSA', 'LastName': 'Stringer', 'Affiliation': ""Division of Global Women's Health, Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States of America.""}, {'ForeName': 'Carol E', 'Initials': 'CE', 'LastName': 'Golin', 'Affiliation': 'Department of Health Behavior, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States of America.'}]",PloS one,['10.1371/journal.pone.0238748']
2943,32971161,"Treatment of women's sexual dysfunction using Apium graveolens L. Fruit (celery seed): A double-blind, randomized, placebo-controlled clinical trial.","ETHNOPHARMACOLOGICAL RELEVANCE


Traditional manuscripts refer to plants such as Apium graveolens L. Fruit (celery seed), which could be used to improve sexual function among women. Since that time, local herbal shops in Iran continue to provide this herb as a natural aphrodisiac product.
AIM OF THE STUDY


This study aimed to evaluate the efficacy and safety of celery seed for the treatment of female sexual dysfunction.
METHODS AND MATERIALS


In this parallel, randomized, double-blinded clinical trial, 80 women were assigned to receive either 500 mg of celery seed or placebo 3 times a day for a period of 6 weeks (n = 40 per group). The female sexual function index (FSFI) questionnaire was used to evaluate women's sexual function before and after treatment.
RESULTS


At the end of the sixth week, an improvement in the total FSFI score was significantly greater in celery seed-treated women than those receiving the placebo (P < 0.001). Increased total FSFI score is mainly contributed by improvement in the sexual desire (p < 0.001), arousal (p < 0.001), lubrication (p < 0.001), and pain (p = 0.033) domains at the endpoint of study. No serious side effects were noticed in both groups during the study period.
CONCLUSION


It seems that celery seed improved sexual function in women and could be used as a safe, well-tolerated, and effective herbal medicine in women with sexual dysfunction.",2020,"At the end of the sixth week, an improvement in the total FSFI score was significantly greater in celery seed-treated women than those receiving the placebo (P<0.001).","['female sexual dysfunction', ""women's sexual dysfunction using Apium graveolens L. Fruit (celery seed"", 'women with sexual dysfunction', 'Traditional manuscripts refer to plants such as Apium graveolens L. Fruit (celery seed', '80 women']","['placebo', '500 mg of celery seed or placebo', 'Placebo']","['serious side effects', 'total FSFI score', 'efficacy and safety', 'arousal', 'female sexual function index (FSFI) questionnaire', 'sexual function', 'sexual desire', 'lubrication', 'pain']","[{'cui': 'C1112442', 'cui_str': 'Female sexual dysfunction'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0549622', 'cui_str': 'Sexual disorder'}, {'cui': 'C0996918', 'cui_str': 'Apium'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0453248', 'cui_str': 'Celery seed'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0600659', 'cui_str': 'Manuscripts'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0032098', 'cui_str': 'Kingdom Viridiplantae'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0453248', 'cui_str': 'Celery seed'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0278098', 'cui_str': 'Female sexual function'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0023618', 'cui_str': 'Libido'}, {'cui': 'C0024069', 'cui_str': 'Lubrication'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",80.0,0.412374,"At the end of the sixth week, an improvement in the total FSFI score was significantly greater in celery seed-treated women than those receiving the placebo (P<0.001).","[{'ForeName': 'Kamran', 'Initials': 'K', 'LastName': 'Hessami', 'Affiliation': 'Student Research Committee, Shiraz University of Medical Sciences, Shiraz, Iran; Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Tahereh', 'Initials': 'T', 'LastName': 'Rahnavard', 'Affiliation': 'Student Research Committee, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Ayda', 'Initials': 'A', 'LastName': 'Hosseinkhani', 'Affiliation': 'Research Center of Traditional Medicine and History of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Azima', 'Affiliation': 'Department of Midwifery, School of Nursing and Midwifery, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mehrab', 'Initials': 'M', 'LastName': 'Sayadi', 'Affiliation': 'Department of Biostatistics, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Azam', 'Initials': 'A', 'LastName': 'Faraji', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Massoumeh', 'Initials': 'M', 'LastName': 'Emamghoreishi', 'Affiliation': 'Department of Pharmacology, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Homeira', 'Initials': 'H', 'LastName': 'Vafaei', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Anahita', 'Initials': 'A', 'LastName': 'Hessami', 'Affiliation': 'School of Pharmacy, International Branch, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: anna_hessami@yahoo.com.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Foroughinia', 'Affiliation': 'Box Hill Hospital, FRANZCOG, Victoria, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Maasumeh Kaviani', 'Affiliation': 'Department of Midwifery, School of Nursing and Midwifery, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Shohreh', 'Initials': 'S', 'LastName': 'Roozmeh', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Nasrin', 'Initials': 'N', 'LastName': 'Asadi', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: nasadi2012@yahoo.ca.'}]",Journal of ethnopharmacology,['10.1016/j.jep.2020.113400']
2944,32971163,Episiotomy wound healing by Commiphora myrrha (Nees) Engl. and Boswellia carteri Birdw. in primiparous women: A randomized controlled trial.,"ETHNOPHARMACOLOGICAL RELEVANCE


Traditional Persian medicine manuscripts refer to plants such as Commiphora myrrha (Nees) Engl. (myrrh) and Boswellia carteri Birdw. (frankincense), which could be used to improve wound healing process. Since that time, local midwives in Iran continue to provide these herbs to precipitate episiotomy wound healing.
AIM OF THE STUDY


To investigate the efficacy and safety of myrrh- and frankincense-based sitz-baths on episiotomy wound healing in primiparous women.
MATERIALS AND METHODS


This randomized controlled trial was conducted on 90 primiparous women with singleton pregnancies after normal vaginal delivery at Hafez hospital affiliated to Shiraz University of Medical Sciences from July to October 2019. Study participants were randomly allocated in three groups (2 intervention groups and 1 control group). Women in intervention groups were assigned to receive either 10-min sitz-bath of myrrh extract or frankincense extract twice a day for 1 week. While the women in control group received the betadine sitz-bath for the same period of time. The main outcome was the episiotomy wound healing, which was measured using the REEDA scale before intervention, on 2nd and 7th postpartum days.
RESULTS


An improvement in the episiotomy wound healing was significantly greater in patients receiving myrrh than those receiving the frankincense or betadine on 2nd (p = 0.003 and p < 0.001) and 7th (p = 0.043 and p = 0.015) postpartum days. However, the total REEDA score was not statistically different between the frankincense and betadine groups on 2nd and 7th postpartum days (p > 0.05).
CONCLUSION


The present results suggest that myrrh was more efficient than frankincense and betadine in healing of the episiotomy wound and could be recommended as a safe natural therapy.",2020,An improvement in the episiotomy wound healing was significantly greater in patients receiving myrrh than those receiving the frankincense or betadine on 2 nd  (p=0.003 and p<0.001) and 7 th  (p=0.043 and p=0.015) postpartum days.,"['primiparous women', 'Traditional Persian medicine manuscripts refer to plants such as Commiphora myrrha (Nees) Engl', '90 primiparous women with singleton pregnancies after normal vaginal delivery at Hafez hospital affiliated to Shiraz University of Medical Sciences from July to October 2019']","['betadine sitz-bath', 'myrrh- and frankincense-based sitz-baths', 'betadine', '10-minute sitz-bath of myrrh extract or frankincense extract']","['total REEDA score', 'efficacy and safety', 'Episiotomy wound healing', 'episiotomy wound healing, which was measured using the REEDA scale', 'episiotomy wound healing']","[{'cui': 'C0033150', 'cui_str': 'Para 1'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0031188', 'cui_str': 'Persian language'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0600659', 'cui_str': 'Manuscripts'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0032098', 'cui_str': 'Kingdom Viridiplantae'}, {'cui': 'C1536360', 'cui_str': 'Commiphora molmol'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0269694', 'cui_str': 'Normal delivery procedure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}]","[{'cui': 'C0699524', 'cui_str': 'Betadine'}, {'cui': 'C0207011', 'cui_str': 'Myrrh extract'}, {'cui': 'C0949991', 'cui_str': 'Boswellia sacra'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C3256678', 'cui_str': 'Frankincense extract'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0014586', 'cui_str': 'Episiotomy'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",90.0,0.0403952,An improvement in the episiotomy wound healing was significantly greater in patients receiving myrrh than those receiving the frankincense or betadine on 2 nd  (p=0.003 and p<0.001) and 7 th  (p=0.043 and p=0.015) postpartum days.,"[{'ForeName': 'Azam', 'Initials': 'A', 'LastName': 'Faraji', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: farajiaz@sums.ac.ir.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Aghdaki', 'Affiliation': 'Obstetrics and Gynecology Department, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: maryam.aghdaki@yahoo.com.'}, {'ForeName': 'Kamran', 'Initials': 'K', 'LastName': 'Hessami', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran; Student Research Committee, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: hessamikamran@gmail.com.'}, {'ForeName': 'Ayda', 'Initials': 'A', 'LastName': 'Hosseinkhani', 'Affiliation': 'Thoracic and Vascular Surgery Research Center, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: hoseinkhan@sums.ac.ir.'}, {'ForeName': 'Shohreh', 'Initials': 'S', 'LastName': 'Roozmeh', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: dr.roozmeh1995@yahoo.com.'}, {'ForeName': 'Nasrin', 'Initials': 'N', 'LastName': 'Asadi', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: nasadi2012@yahoo.ca.'}, {'ForeName': 'Homeira', 'Initials': 'H', 'LastName': 'Vafaei', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: vafaeih@gmail.com.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Kasraeian', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: kasraeemm@yahoo.com.'}, {'ForeName': 'Roya', 'Initials': 'R', 'LastName': 'Bagheri', 'Affiliation': 'School of Nursing &Midwifery, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: royakianbagheri64@gmail.com.'}, {'ForeName': 'Khadije', 'Initials': 'K', 'LastName': 'Bazrafshan', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: bazrafshan.kh@gmail.com.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Foroughinia', 'Affiliation': 'Box Hill Hospital, FRANZCOG, Eastern Health, Victoria, Australia. Electronic address: Foroughinialeila@yahoo.com.au.'}]",Journal of ethnopharmacology,['10.1016/j.jep.2020.113396']
2945,32971277,Practical telehealth to improve control and engagement for patients with clinic-refractory diabetes mellitus (PRACTICE-DM): Protocol and baseline data for a randomized trial.,"BACKGROUND


Persistent poorly-controlled type 2 diabetes mellitus (PPDM), or maintenance of a hemoglobin A1c (HbA1c) ≥8.5% despite receiving clinic-based diabetes care, contributes disproportionately to the national diabetes burden. Comprehensive telehealth interventions may help ameliorate PPDM, but existing approaches have rarely been designed with clinical implementation in mind, limiting use in routine practice. We describe a study testing a novel telehealth intervention that comprehensively targets clinic-refractory PPDM, and was explicitly developed for practical delivery using existing Veterans Health Administration (VHA) clinical infrastructure.
METHODS


Practical Telehealth to Improve Control and Engagement for Patients with Clinic-Refractory Diabetes Mellitus (PRACTICE-DM) is an ongoing randomized controlled trial comparing two 12-month interventions: 1) standard VHA Home Telehealth (HT) telemonitoring/care coordination; or 2) the PRACTICE-DM intervention, a comprehensive HT-delivered intervention combining telemonitoring, self-management support, diet/activity support, medication management, and depression management. The primary outcome is HbA1c. Secondary outcomes include diabetes distress, self-care, self-efficacy, weight, depressive symptoms, implementation barriers/facilitators, and costs. We hypothesize that the PRACTICE-DM intervention will reduce HbA1c by >0.6% versus standard HT over 12 months.
RESULTS


Enrollment for this ongoing trial concluded in January 2020; 200 patients were randomized (99 to standard HT and 101 to the PRACTICE-DM intervention). The cohort has a mean age of 58 and is 23% female and 72% African American. Mean baseline HbA1c and BMI were 10.2% and 34.8 kg/m 2 .
CONCLUSIONS


Because it comprehensively targets factors underlying PPDM using existing clinical infrastructure, the PRACTICE-DM intervention may be well suited to lower the complications and costs of PPDM in routine practice.",2020,"Methods Practical Telehealth to Improve Control and Engagement for Patients with Clinic-Refractory Diabetes Mellitus (PRACTICE-DM) is an ongoing randomized controlled trial comparing two 12-month interventions: 1) standard VHA Home Telehealth (HT) telemonitoring/care coordination; or 2) the PRACTICE-DM intervention, a comprehensive HT-delivered intervention combining telemonitoring, self-management support, diet/activity support, medication management, and depression management.","['mean age of 58 and is 23% female and 72% African American', 'Patients with Clinic-Refractory Diabetes Mellitus', 'January 2020; 200 patients', 'patients with clinic-refractory diabetes mellitus (PRACTICE-DM']","['comprehensive HT-delivered intervention combining telemonitoring, self-management support, diet/activity support, medication management, and depression management', 'standard VHA Home Telehealth (HT) telemonitoring/care coordination']","['diabetes distress, self-care, self-efficacy, weight, depressive symptoms, implementation barriers/facilitators, and costs', 'Mean baseline HbA1c and BMI']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0618884', 'cui_str': 'IS 23'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0150270', 'cui_str': 'Management of drug regimen'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0242414', 'cui_str': 'Coordination'}]","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",200.0,0.0844592,"Methods Practical Telehealth to Improve Control and Engagement for Patients with Clinic-Refractory Diabetes Mellitus (PRACTICE-DM) is an ongoing randomized controlled trial comparing two 12-month interventions: 1) standard VHA Home Telehealth (HT) telemonitoring/care coordination; or 2) the PRACTICE-DM intervention, a comprehensive HT-delivered intervention combining telemonitoring, self-management support, diet/activity support, medication management, and depression management.","[{'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Kobe', 'Affiliation': 'Duke University School of Medicine, Durham, NC, United States of America.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Edelman', 'Affiliation': 'Durham Veterans Affairs Center of Innovation to Accelerate Discovery and Practice Change (ADAPT), Durham, NC, United States of America; Division of General Internal Medicine, Department of Medicine, Duke University School of Medicine, Durham, NC, United States of America.'}, {'ForeName': 'Phillip E', 'Initials': 'PE', 'LastName': 'Tarkington', 'Affiliation': 'Central Virginia Veterans Affairs Health Care System, Richmond, VA, United States of America.'}, {'ForeName': 'Hayden B', 'Initials': 'HB', 'LastName': 'Bosworth', 'Affiliation': 'Durham Veterans Affairs Center of Innovation to Accelerate Discovery and Practice Change (ADAPT), Durham, NC, United States of America; Division of General Internal Medicine, Department of Medicine, Duke University School of Medicine, Durham, NC, United States of America; Department of Population Health Sciences, Duke University School of Medicine, Durham, NC, United States of America.'}, {'ForeName': 'Matthew L', 'Initials': 'ML', 'LastName': 'Maciejewski', 'Affiliation': 'Durham Veterans Affairs Center of Innovation to Accelerate Discovery and Practice Change (ADAPT), Durham, NC, United States of America; Division of General Internal Medicine, Department of Medicine, Duke University School of Medicine, Durham, NC, United States of America; Department of Population Health Sciences, Duke University School of Medicine, Durham, NC, United States of America.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Steinhauser', 'Affiliation': 'Durham Veterans Affairs Center of Innovation to Accelerate Discovery and Practice Change (ADAPT), Durham, NC, United States of America.'}, {'ForeName': 'Amy S', 'Initials': 'AS', 'LastName': 'Jeffreys', 'Affiliation': 'Durham Veterans Affairs Center of Innovation to Accelerate Discovery and Practice Change (ADAPT), Durham, NC, United States of America.'}, {'ForeName': 'Cynthia J', 'Initials': 'CJ', 'LastName': 'Coffman', 'Affiliation': 'Durham Veterans Affairs Center of Innovation to Accelerate Discovery and Practice Change (ADAPT), Durham, NC, United States of America; Department of Biostatistics and Bioinformatics, Duke University School of Medicine, Durham, NC, United States of America.'}, {'ForeName': 'Valerie A', 'Initials': 'VA', 'LastName': 'Smith', 'Affiliation': 'Durham Veterans Affairs Center of Innovation to Accelerate Discovery and Practice Change (ADAPT), Durham, NC, United States of America; Division of General Internal Medicine, Department of Medicine, Duke University School of Medicine, Durham, NC, United States of America; Department of Population Health Sciences, Duke University School of Medicine, Durham, NC, United States of America.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Strawbridge', 'Affiliation': 'Durham Veterans Affairs Center of Innovation to Accelerate Discovery and Practice Change (ADAPT), Durham, NC, United States of America.'}, {'ForeName': 'Steven T', 'Initials': 'ST', 'LastName': 'Szabo', 'Affiliation': 'Durham Veterans Affairs Health Care System, Durham, NC, United States of America; Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, United States of America; VA Mid-Atlantic Mental Illness, Research, Education and Clinical Center, Durham, NC, United States of America.'}, {'ForeName': 'Shivan', 'Initials': 'S', 'LastName': 'Desai', 'Affiliation': 'Central Virginia Veterans Affairs Health Care System, Richmond, VA, United States of America.'}, {'ForeName': 'Mary P', 'Initials': 'MP', 'LastName': 'Garrett', 'Affiliation': 'Durham Veterans Affairs Health Care System, Durham, NC, United States of America.'}, {'ForeName': 'Theresa C', 'Initials': 'TC', 'LastName': 'Wilmot', 'Affiliation': 'Durham Veterans Affairs Health Care System, Durham, NC, United States of America.'}, {'ForeName': 'Teresa J', 'Initials': 'TJ', 'LastName': 'Marcano', 'Affiliation': 'Central Virginia Veterans Affairs Health Care System, Richmond, VA, United States of America.'}, {'ForeName': 'Donna L', 'Initials': 'DL', 'LastName': 'Overby', 'Affiliation': 'Central Virginia Veterans Affairs Health Care System, Richmond, VA, United States of America.'}, {'ForeName': 'Glenda A', 'Initials': 'GA', 'LastName': 'Tisdale', 'Affiliation': 'Central Virginia Veterans Affairs Health Care System, Richmond, VA, United States of America.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Durkee', 'Affiliation': 'Department of Pharmacy, Durham Veterans Affairs Health Care System, Durham, NC, United States of America.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Bullard', 'Affiliation': 'Department of Pharmacy, Durham Veterans Affairs Health Care System, Durham, NC, United States of America.'}, {'ForeName': 'Moahad S', 'Initials': 'MS', 'LastName': 'Dar', 'Affiliation': 'Greenville VA Health Care Center, Greenville, NC, United States of America; Division of Endocrinology, Department of Medicine, Brody School of Medicine at East Carolina University, Greenville, NC, United States of America.'}, {'ForeName': 'Amy C', 'Initials': 'AC', 'LastName': 'Mundy', 'Affiliation': 'Central Virginia Veterans Affairs Health Care System, Richmond, VA, United States of America.'}, {'ForeName': 'Janette', 'Initials': 'J', 'LastName': 'Hiner', 'Affiliation': 'Central Virginia Veterans Affairs Health Care System, Richmond, VA, United States of America.'}, {'ForeName': 'Sonja K', 'Initials': 'SK', 'LastName': 'Fredrickson', 'Affiliation': 'Central Virginia Veterans Affairs Health Care System, Richmond, VA, United States of America.'}, {'ForeName': 'Nadya T', 'Initials': 'NT', 'LastName': 'Majette Elliott', 'Affiliation': 'Durham Veterans Affairs Center of Innovation to Accelerate Discovery and Practice Change (ADAPT), Durham, NC, United States of America.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Howard', 'Affiliation': 'Durham Veterans Affairs Center of Innovation to Accelerate Discovery and Practice Change (ADAPT), Durham, NC, United States of America.'}, {'ForeName': 'Deborah H', 'Initials': 'DH', 'LastName': 'Jeter', 'Affiliation': 'Central Virginia Veterans Affairs Health Care System, Richmond, VA, United States of America.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Danus', 'Affiliation': 'Durham Veterans Affairs Center of Innovation to Accelerate Discovery and Practice Change (ADAPT), Durham, NC, United States of America.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Crowley', 'Affiliation': 'Durham Veterans Affairs Center of Innovation to Accelerate Discovery and Practice Change (ADAPT), Durham, NC, United States of America; Division of Endocrinology, Department of Medicine, Duke University School of Medicine, Durham, NC, United States of America. Electronic address: matthew.crowley@duke.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106157']
2946,32971302,"Manual push technique, an alternative route of subcutaneous immunoglobulin administration in chronic inflammatory demyelinating polyradiculoneuropathy: A proof-of-concept study.","OBJECTIVE


Subcutaneous immunoglobulin (SCIg) administered through infusion pump has been reported as effective in chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) patients. In this study we evaluate an alternative technique of SCIg administration, based on the delivery of lower volumes administered daily using manual push technique (MPT) in 10 CIDP patients.
METHODS


In this randomized, controlled, two-arm, crossover clinical trial, CIDP patients were randomly assigned 1:1 to receive SCIg either by MPT or pumps for 4 consecutive months with crossover to the other. The primary objective was to assess whether MPT had the same effectiveness as pumps. The secondary objectives were to assess whether MPT resulted in greater plasma IgG levels and improved quality of life (QoL).
RESULTS


Ten patients (mean age = 48.3) were enrolled. No significant changes were observed in the efficacy parameters (INCAT, MRC, R-ODS, and GS scales). A positive mean variation of 5.4 % in plasma IgG levels in the group treated with MPT was observed at the end of MPT periods. Treatment interference, which is one of the dimensions of the Life Quality Index, showed a significant improvement in the MPT periods.
CONCLUSION


In CIDP patients, the MPT technique was as effective as pump infusion, allowed comparable, slightly increases plasma IgG levels, and also improved the QoL.",2020,"No significant changes were observed in the efficacy parameters (INCAT, MRC, R-ODS, and GS scales).","['chronic inflammatory demyelinating polyradiculoneuropathy', 'Ten patients (mean age\u202f=\u202f48.3) were enrolled', '10 CIDP patients', 'CIDP patients', 'chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) patients']","['Subcutaneous immunoglobulin (SCIg', 'manual push technique (MPT', 'subcutaneous immunoglobulin administration', 'SCIg either by MPT', 'MPT']","['efficacy parameters (INCAT, MRC, R-ODS, and GS scales', 'plasma IgG levels', 'plasma IgG levels and improved quality of life (QoL']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0032587', 'cui_str': 'Polyradiculoneuropathy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0021027', 'cui_str': 'Immunoglobulin'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0580841', 'cui_str': 'Does push'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",10.0,0.0784501,"No significant changes were observed in the efficacy parameters (INCAT, MRC, R-ODS, and GS scales).","[{'ForeName': 'Dario', 'Initials': 'D', 'LastName': 'Cocito', 'Affiliation': 'Divisione di Riabilitazione Neuromotoria, Istituti Clinici Scientifici Maugeri, Presidio Sanitario Major, Via Santa Giulia, 60, 10124, Torino, Italy. Electronic address: dariococito@yahoo.it.'}, {'ForeName': 'Erdita', 'Initials': 'E', 'LastName': 'Peci', 'Affiliation': 'Divisione di Riabilitazione Neuromotoria, Istituti Clinici Scientifici Maugeri, Presidio Sanitario Major, Via Santa Giulia, 60, 10124, Torino, Italy. Electronic address: erditapeci@gmail.com.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Rigaldo', 'Affiliation': 'Dipartimento di Neuroscienze - Università di Torino, A.O.U. Città della Salute e della Scienza di Torino, Corso Bramante, 88, 10126, Torino, Italy. Electronic address: simonarigaldo@yahoo.com.'}, {'ForeName': 'Carlotta', 'Initials': 'C', 'LastName': 'Canavese', 'Affiliation': 'Dipartimento di Neuroscienze - Università di Torino, A.O.U. Città della Salute e della Scienza di Torino, Corso Bramante, 88, 10126, Torino, Italy. Electronic address: ccanavese@cittadellasalute.to.it.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Migliaretti', 'Affiliation': 'Dipartimento di Sanità Pubblica e Scienze Pediatriche - Università di Torino, Piazza Polonia, 94, 10126 Torino, Italy. Electronic address: giuseppe.migliaretti@unito.it.'}, {'ForeName': 'Federico M', 'Initials': 'FM', 'LastName': 'Cossa', 'Affiliation': 'Divisione di Riabilitazione Neuromotoria, Istituti Clinici Scientifici Maugeri, Presidio Sanitario Major, Via Santa Giulia, 60, 10124, Torino, Italy. Electronic address: federico.cossa@icsmaugeri.it.'}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2020.106240']
2947,32971314,Quality of life after response to acute-phase cognitive therapy for recurrent depression.,"BACKGROUND


Adults with major depressive disorder (MDD) often experience reduced quality of life (QOL). Efficacious acute-phase treatments, including cognitive therapy (CT) or medication, decrease depressive symptoms and, to a lesser degree, increase QOL. We tested longer-term changes in QOL after response to acute-phase CT, including the potential effects of continuation treatment for depression and time-lagged relations between QOL and depressive symptoms.
METHODS


Responders to acute-phase CT (N = 290) completed QOL and depressive symptom assessments repeatedly for 32 post-acute months. Higher-risk responders were randomized to 8 months of continuation treatment (CT, fluoxetine, or pill placebo) and then entered a 24-month follow-up. Lower-risk responders were only assessed for 32 months.
RESULTS


On average, large gains in QOL made during acute-phase CT response were maintained for 32 months. Continuation CT or fluoxetine did not improve QOL relative to pill placebo. Controlling for residual depressive symptoms, higher QOL after acute-phase CT response was a protective factor against MDD relapse and recurrence. Higher QOL predicted subsequent reductions in depressive symptom severity, but depressive symptom severity did not predict subsequent changes in QOL.
LIMITATIONS


Generalization of results to other patient populations, treatments, and measures is uncertain. The clinical trial was not designed to test relations between QOL and depression. Replication is needed before clinical application of these results.
CONCLUSIONS


Gains in QOL made during response to acute-phase CT are relatively stable and may help protect against relapse/recurrence. Continuation CT or fluoxetine may not further improve QOL among acute-phase CT responders.",2020,"Controlling for residual depressive symptoms, higher QOL after acute-phase CT response was a protective factor against MDD relapse and recurrence.","['Responders to acute-phase CT', 'Adults with major depressive disorder (MDD', 'recurrent depression', 'Higher-risk responders']","['cognitive therapy (CT', 'continuation treatment (CT, fluoxetine, or pill placebo', 'fluoxetine']","['QOL relative', 'depressive symptom severity', 'quality of life (QOL', 'QOL and depressive symptom assessments', 'QOL', 'Quality of life']","[{'cui': 'C0439557', 'cui_str': 'Acute phase'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0221480', 'cui_str': 'Recurrent depression'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0016365', 'cui_str': 'Fluoxetine'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",290.0,0.0234422,"Controlling for residual depressive symptoms, higher QOL after acute-phase CT response was a protective factor against MDD relapse and recurrence.","[{'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'Vittengl', 'Affiliation': 'Department of Psychology, Truman State University, 100 East Normal Street, Kirksville, MO 63501-4221, USA. Electronic address: vittengl@truman.edu.'}, {'ForeName': 'Manish K', 'Initials': 'MK', 'LastName': 'Jha', 'Affiliation': 'Department of Psychiatry, Icahn School of Medicine at Mount Sinai.'}, {'ForeName': 'Abu', 'Initials': 'A', 'LastName': 'Minhajuddin', 'Affiliation': 'Department of Population and Data Sciences, University of Texas Southwestern Medical Center.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Thase', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania.'}, {'ForeName': 'Robin B', 'Initials': 'RB', 'LastName': 'Jarrett', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd., Dallas, TX 75390-9149, USA. Electronic address: Robin.Jarrett@UTSouthwestern.edu.'}]",Journal of affective disorders,['10.1016/j.jad.2020.09.059']
2948,32971388,Perceptions of U.S. and Canadian Cannabis Package Warnings Among U.S. Adults.,"BACKGROUND


Cannabis warning labels can communicate risks, but there is little research on warning perceptions and differences by product type.
METHODS


In a 2019 online survey, 1,000 U.S. adults (500 cannabis users and 500 cannabis non-users who used tobacco) were randomly assigned to view no warning or one of four U.S. or Canadian warnings displayed on images of packaging for dried flower or edible cannabis. The warnings described cannabis risks related to psychosis, addiction, lack of FDA oversight, and impaired driving. We used linear regression to examine perceptions of warnings and product harm as a function of product type (dried or edible) and warning. We examined which warning participants selected as most effective for discouraging youth use and impaired driving.
RESULTS


Participants found the addiction warning (cannabis users: B = -1.04, p < 0.001; cannabis non-users: B = 1.17, p < 0.001) and psychosis warning (users: B = -0.65, p < 0.05; non-users: B = -0.71, p < 0.05) less believable than the driving warning but indicated that they learned more from the psychosis warning than the driving warning (users: B = 0.88, p < 0.01; non-users (B = 1.60, p < 0.001). Participants viewing any warning considered smoking cannabis to be more harmful than those viewing no warning (all p < 0.05). The psychosis warning was most frequently selected as the best warning for discouraging youth use.
CONCLUSIONS


Warnings have the potential to educate consumers and impact cannabis harm perceptions. Warnings have similar effects across product types, potentially eliminating the need for product type-specific warnings. The association of cannabis use with risk for psychosis, a topic addressed in Canadian warnings, could be a useful topic of focus in U.S. warnings.",2020,Participants viewing any warning considered smoking cannabis to be more harmful than those viewing no warning (all p < 0.05).,"['In a 2019 online survey, 1,000 U.S. adults (500 cannabis users and 500 cannabis non-users who used tobacco', 'Perceptions of U.S. and Canadian Cannabis Package Warnings Among U.S. Adults']",['view no warning or one of four U.S. or Canadian warnings displayed on images of packaging for dried flower or edible cannabis'],"['addiction warning', 'psychosis warning']","[{'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}]","[{'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C0556574', 'cui_str': 'Dried flowers'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}]","[{'cui': 'C0085281', 'cui_str': 'Addiction'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}]",,0.0480856,Participants viewing any warning considered smoking cannabis to be more harmful than those viewing no warning (all p < 0.05).,"[{'ForeName': 'Jessica K', 'Initials': 'JK', 'LastName': 'Pepper', 'Affiliation': 'Center for Health Policy Science & Tobacco Research, RTI International, 3040 E. Cornwallis Rd., Research Triangle Park, NC, USA. Electronic address: jpepper@rti.org.'}, {'ForeName': 'Youn Ok', 'Initials': 'YO', 'LastName': 'Lee', 'Affiliation': 'Center for Health Policy Science & Tobacco Research, RTI International, 3040 E. Cornwallis Rd., Research Triangle Park, NC, USA.'}, {'ForeName': 'Matthew E', 'Initials': 'ME', 'LastName': 'Eggers', 'Affiliation': 'Center for Health Policy Science & Tobacco Research, RTI International, 3040 E. Cornwallis Rd., Research Triangle Park, NC, USA.'}, {'ForeName': 'Jane A', 'Initials': 'JA', 'LastName': 'Allen', 'Affiliation': 'Center for Health Policy Science & Tobacco Research, RTI International, 3040 E. Cornwallis Rd., Research Triangle Park, NC, USA.'}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Thompson', 'Affiliation': 'Center for Health Policy Science & Tobacco Research, RTI International, 3040 E. Cornwallis Rd., Research Triangle Park, NC, USA.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Nonnemaker', 'Affiliation': 'Center for Health Policy Science & Tobacco Research, RTI International, 3040 E. Cornwallis Rd., Research Triangle Park, NC, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108275']
2949,32971450,Improving the endothelial dysfunction in type 2 diabetes with chromium and vitamin D 3  byreducing homocysteine and oxidative stress: A randomized placebo-controlled trial.,"BACKGROUND


Chromium picolinate (CrPic) and vitamin D3 are known as two antioxidant micronutrients. Through inducing endothelial dysfunction, oxidants such as homocysteine (Hct) and malondialdehyde (MDA) lead to cardiovascular disease in type 2 diabetes mellitus (T2DM). No published data has directly examined the effects of these two antioxidants on improving the endothelial dysfunction in T2DM throughreducing homocysteine and oxidative stress.
METHODS


Subjects (n = 92) in this randomized, double blind, placebo-control study were randomly assigned to receive oral placebo (group I), D 3  (group II: 50,000 IU/ week), chromium picolinate (CrPic) (group III: 500 μg/day), and both vitamin D 3  and CrPic (group IV) for four months. Fasting blood samples were drawn at study baseline and following intervention to determine Hct, MDA, total antioxidant capacity (TAC), total thiol groups (SHs), vascular cell adhesion molecule- 1 (VCAM-1), and plasminogen activator inhibitor-1 (PAI-1).
RESULTS


After intervention, MDA significantly decreased in groups II and IV; TAC significantly increased in group IV, and SHs significantly augmented in group III; Hct was significantly reduced in groups II, III, and IV; and VCAM-1 significantly decreased in groups III and IV and PAI-1 was significantly reduced in groups II, III, and IV.
CONCLUSION


Our findings suggest that through reducing homocysteine and oxidative stress and improving endothelial dysfunction, chromium and vitamin D 3  co-supplementation might be predictive and preventive of cardiovascular diseasesassociated with T2DM. IRCT, IRCT20190610043852N1, registered 21 October 2019, https://fa.irct.ir/user/trial/42293/view.",2020,"After intervention, MDA significantly decreased in groups II and IV; TAC significantly increased in group IV, and SHs significantly augmented in group III; Hct was significantly reduced in groups II, III, and IV; and VCAM-1 significantly decreased in groups III and IV and PAI-1 was significantly reduced in groups II, III, and IV.
","['Subjects (n = 92', 'type 2 diabetes mellitus (T2DM']","['chromium and vitamin D', 'vitamin D 3  and CrPic', 'Chromium picolinate (CrPic) and vitamin D3', 'oral placebo', 'placebo', 'chromium picolinate (CrPic']","['MDA', 'VCAM-1', 'Hct, MDA, total antioxidant capacity (TAC), total thiol groups (SHs), vascular cell adhesion molecule', 'endothelial dysfunction, oxidants such as homocysteine (Hct) and malondialdehyde (MDA', 'Fasting blood samples', '1 (VCAM-1), and plasminogen activator inhibitor-1 (PAI-1', 'homocysteine and oxidative stress', 'endothelial dysfunction']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]","[{'cui': 'C0008574', 'cui_str': 'Chromium'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0163657', 'cui_str': 'CHROMIUM PICOLINATE'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0078056', 'cui_str': 'Lymphocyte antigen CD106'}, {'cui': 'C0019878', 'cui_str': 'Homocysteine'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0038734', 'cui_str': 'Sulfhydryls'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0856169', 'cui_str': 'Endothelial dysfunction'}, {'cui': 'C0085403', 'cui_str': 'Oxidizing Agents'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0030190', 'cui_str': 'Plasminogen activator inhibitor-1'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}]",,0.150688,"After intervention, MDA significantly decreased in groups II and IV; TAC significantly increased in group IV, and SHs significantly augmented in group III; Hct was significantly reduced in groups II, III, and IV; and VCAM-1 significantly decreased in groups III and IV and PAI-1 was significantly reduced in groups II, III, and IV.
","[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Imanparast', 'Affiliation': 'Traditional and Complementary Medicine Research Center, Arak University of Medical Sciences, Arak, Iran; Department of Biochemistry, Khomein University of Medical Sciences, Khomein, Iran. Electronic address: Fatemeh.Imanparast@arakmu.ac.ir.'}, {'ForeName': 'Farideh Jalali', 'Initials': 'FJ', 'LastName': 'Mashayekhi', 'Affiliation': 'Department of Biochemistry and Genetics, Faculty of Medicine, Arak University of Medical Sciences, Arak, Iran; Department of Laboratory Sciences, Faculty of Paramedicine, Arak University of Medical Sciences, Arak, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Kamankesh', 'Affiliation': 'Department of Biochemistry, Khomein University of Medical Sciences, Khomein, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Rafiei', 'Affiliation': 'Department of Biostatistics and Epidemiology, School of Health, Scientific Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Pegah', 'Initials': 'P', 'LastName': 'Mohaghegh', 'Affiliation': 'Community and Preventive Medicine Specialist, Department of community medicine, Faculty of Medicine, Arak University of Medical Sciences, Arak,Iran.'}, {'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Alimoradian', 'Affiliation': 'Department of Pharmacology, School of Medicine, Arak University of Medical Sciences, Arak, Iran.'}]",Journal of trace elements in medicine and biology : organ of the Society for Minerals and Trace Elements (GMS),['10.1016/j.jtemb.2020.126639']
2950,32971774,Pre-Sleep Low Glycemic Index Modified Starch Does Not Improve Next-Morning Fuel Selection or Running Performance in Male and Female Endurance Athletes.,"To determine the effects of pre-sleep supplementation with a novel low glycemic index (LGI) carbohydrate (CHO) on next-morning substrate utilization, gastrointestinal distress (GID), and endurance running performance (5-km time-trial, TT). Using a double-blind, randomized, placebo (PLA) controlled, crossover design, trained participants ( n  = 14; 28 ± 9 years, 8/6 male/female, 55 ± 7 mL/kg/min) consumed a LGI, high glycemic index (HGI), or 0 kcal PLA supplement ≥ 2 h after their last meal and <30 min prior to sleep. Upon arrival, resting energy expenditure (REE), substrate utilization, blood glucose, satiety, and GID were assessed. An incremental exercise test (IET) was performed at 55, 65, and 75% peak volume of oxygen consumption (VO 2peak ) with GID, rating of perceived exertion (RPE) and substrate utilization recorded each stage. Finally, participants completed the 5-km TT. There were no differences in any baseline measure. During IET, CHO utilization tended to be greater with LGI (PLA, 56 ± 11; HGI, 60 ± 14; LGI, 63 ± 14%,  p  = 0.16,  η 2  = 0.14). GID was unaffected by supplementation at any point ( p  > 0.05). Performance was also unaffected by supplement (PLA, 21.6 ± 9.5; HGI, 23.0 ± 7.8; LGI, 24.1 ± 4.5 min,  p  = 0.94,  η 2  = 0.01). Pre-sleep CHO supplementation did not affect next-morning resting metabolism, BG, GID, or 5-km TT performance. The trend towards higher CHO utilization during IET after pre-sleep LGI, suggests that such supplementation increases morning CHO availability.",2020,"Pre-sleep CHO supplementation did not affect next-morning resting metabolism, BG, GID, or 5-km TT performance.","['trained participants ( n  = 14; 28 ± 9 years, 8/6 male/female, 55 ± 7 mL/kg/min) consumed a', 'Male and Female Endurance Athletes']","['pre-sleep supplementation with a novel low glycemic index (LGI) carbohydrate (CHO', 'Pre-Sleep Low Glycemic Index Modified Starch', 'placebo', 'LGI, high glycemic index (HGI), or 0 kcal PLA supplement ≥ 2 h after their last meal and <30 min prior to sleep', 'Pre-sleep CHO supplementation']","['Performance', 'next-morning substrate utilization, gastrointestinal distress (GID), and endurance running performance (5-km time-trial, TT', 'oxygen consumption (VO 2peak ) with GID, rating of perceived exertion (RPE) and substrate utilization recorded each stage', 'CHO utilization', 'GID', 'next-morning resting metabolism, BG, GID, or 5-km TT performance', 'morning CHO availability', 'Upon arrival, resting energy expenditure (REE), substrate utilization, blood glucose, satiety, and GID']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439402', 'cui_str': 'mL/min/kg'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1136206', 'cui_str': 'Glycemic Index Number'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0054889', 'cui_str': 'CAV protocol'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0038179', 'cui_str': 'Starch'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0332152', 'cui_str': 'Before'}]","[{'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0548823', 'cui_str': 'Distress gastrointestinal'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0054889', 'cui_str': 'CAV protocol'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0036239', 'cui_str': 'Satiety'}]",,0.412373,"Pre-sleep CHO supplementation did not affect next-morning resting metabolism, BG, GID, or 5-km TT performance.","[{'ForeName': 'Monique D', 'Initials': 'MD', 'LastName': 'Dudar', 'Affiliation': 'Health and Human Physiological Sciences, Skidmore College, Saratoga Springs, NY 12866, USA.'}, {'ForeName': 'Emilie D', 'Initials': 'ED', 'LastName': 'Bode', 'Affiliation': 'Health and Human Physiological Sciences, Skidmore College, Saratoga Springs, NY 12866, USA.'}, {'ForeName': 'Karly R', 'Initials': 'KR', 'LastName': 'Fishkin', 'Affiliation': 'Health and Human Physiological Sciences, Skidmore College, Saratoga Springs, NY 12866, USA.'}, {'ForeName': 'Rochelle A', 'Initials': 'RA', 'LastName': 'Brown', 'Affiliation': 'Health and Human Physiological Sciences, Skidmore College, Saratoga Springs, NY 12866, USA.'}, {'ForeName': 'Madeleine M', 'Initials': 'MM', 'LastName': 'Carre', 'Affiliation': 'Health and Human Physiological Sciences, Skidmore College, Saratoga Springs, NY 12866, USA.'}, {'ForeName': 'Noa R', 'Initials': 'NR', 'LastName': 'Mills', 'Affiliation': 'Health and Human Physiological Sciences, Skidmore College, Saratoga Springs, NY 12866, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Ormsbee', 'Affiliation': 'Department of Nutrition, Food, and Exercise Sciences, Institute of Sport Sciences and Medicine, Florida State University, Tallahassee, FL 32306, USA.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Ives', 'Affiliation': 'Health and Human Physiological Sciences, Skidmore College, Saratoga Springs, NY 12866, USA.'}]",Nutrients,['10.3390/nu12092888']
2951,32972635,Comparison of the effects of Pueraria mirifica gel and of placebo gel on the vaginal microenvironment of postmenopausal women with Genitourinary Syndrome of Menopause (GSM).,"OBJECTIVE


To compare the effects of a 12-week course of 5%Pueraria mirifica gel and placebo gel on the prevalence of bacterial vaginosis, vaginal fungi, vaginal pH, vaginal health index (VHI), and genitourinary symptoms in postmenopausal women.
STUDY DESIGN


In a randomized, double-blinded, placebo-controlled study (TCTR20160517002), 60 postmenopausal women were randomly assigned to a 12-week course of eitherP. mirifica gel or identical placebo gel.
MAIN OUTCOME MEASURE


Vaginal Nugent score, fungal culture, pH, VHI, and genitourinary symptoms were evaluated at baseline and after 12 weeks of treatment.
RESULTS


After 12 weeks of treatment, the proportion of participants with an abnormal Nugent score in the P. mirifica and the placebo groups were 6.7 % (2/30) and 23.3 % (7/30), respectively (p =  0.006). The mean changes in Nugent scores and VHI were significantly higher in the P. mirifica group (p <  0.05). There were no significant decreases in the prevalence of symptoms between the two groups after treatment (p > 0.05).
CONCLUSION


A 12-week course of treatment with 5 % P. mirifica vaginal gel in postmenopausal women with GSM has been proved to be effective in reducing indicators of bacterial vaginosis compared with placebo gel. Nevertheless, the effect on alleviating genital symptoms was not demonstrated.",2020,"There were no significant decreases in the prevalence of symptoms between the two groups after treatment (p > 0.05).
","['60 postmenopausal women', 'postmenopausal women with GSM', 'postmenopausal women', 'postmenopausal women with Genitourinary Syndrome of Menopause (GSM']","['eitherP. mirifica gel or identical placebo gel', '5%Pueraria mirifica gel and placebo gel', 'placebo gel', 'placebo', 'Pueraria mirifica gel']","['prevalence of symptoms', 'mean changes in Nugent scores and VHI', 'alleviating genital symptoms', 'prevalence of bacterial vaginosis, vaginal fungi, vaginal pH, vaginal health index (VHI), and genitourinary symptoms', 'Vaginal Nugent score, fungal culture, pH, VHI, and genitourinary symptoms', 'abnormal Nugent score']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1300564', 'cui_str': 'g/m2'}, {'cui': 'C5192371', 'cui_str': 'Genitourinary syndrome of menopause'}]","[{'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0950068', 'cui_str': 'Puerariae'}]","[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0017420', 'cui_str': 'Reproductive System'}, {'cui': 'C0085166', 'cui_str': 'Bacterial vaginosis'}, {'cui': 'C0016832', 'cui_str': 'Fungi'}, {'cui': 'C0429263', 'cui_str': 'Vaginal pH'}, {'cui': 'C0426317', 'cui_str': 'Genitourinary symptoms'}, {'cui': 'C0200954', 'cui_str': 'Mycology culture'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}]",60.0,0.303347,"There were no significant decreases in the prevalence of symptoms between the two groups after treatment (p > 0.05).
","[{'ForeName': 'Chuleekorn', 'Initials': 'C', 'LastName': 'Sritonchai', 'Affiliation': 'Department of Obstetrics & Gynaecology, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Jittima', 'Initials': 'J', 'LastName': 'Manonai', 'Affiliation': 'Department of Obstetrics & Gynaecology, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand. Electronic address: jittima.man@mahidol.ac.th.'}, {'ForeName': 'Areepan', 'Initials': 'A', 'LastName': 'Sophonsritsuk', 'Affiliation': 'Department of Obstetrics & Gynaecology, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Wichai', 'Initials': 'W', 'LastName': 'Cherdshewasart', 'Affiliation': 'Department of Biology, Faculty of Science, Chulalongkorn University, Bangkok, Thailand.'}]",Maturitas,['10.1016/j.maturitas.2020.06.005']
2952,32974746,Selection of a correct treatment protocol in caesarean scar pregnancies.,"OBJECTIVE


This study aims at assessing the effectiveness of various treatment protocols with the help of some parameters in caesarean scar pregnancies.
METHODS


A total of 26 patients were assessed in the study. The patients were divided into 4 groups. Group 1 consisted of those who had a wedge resection (n = 7), group 2 those who had a suction curettage (n = 10), group 3 those who had a systemic methotrexate (MTX) (n = 5) and group 4 those who had a systemic + local MTX (n = 4). The ßHcg half-lives, haemoglobin levels at the time of admittance and discharge, and hospital stays of the groups were compared.
RESULTS


The difference between group 1 and group 4 was found significant (p = 0.002) with respect to days of hospital stay. There was no statistically significant difference between the groups with respect to ßHcg half-lives and haemoglobin values.
CONCLUSION


The results of our study showed that there were no significant differences between treatment outcomes when appropriate protocols were employed. Therefore, the important point in CSPs is to assess correctly the type of CSP, the myometrial thickness and the patient's hemodynamic condition and select the most appropriate protocol accordingly rather than trying to establish a single standard treatment protocol.",2020,The difference between group 1 and group 4 was found significant (p = 0.002) with respect to days of hospital stay.,"['A total of 26 patients were assessed in the study', 'caesarean scar pregnancies']","['suction curettage', 'wedge resection', 'systemic methotrexate (MTX) (n\u2009=\u20095) and group 4 those who had a systemic\u2009+\u2009local MTX']","['ßHcg half-lives, haemoglobin levels at the time of admittance and discharge, and hospital stays']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C0042223', 'cui_str': 'Suction Curettage'}, {'cui': 'C0184909', 'cui_str': 'Wedge resection - action'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0441876', 'cui_str': 'Group 4'}, {'cui': 'C0205276', 'cui_str': 'Local'}]","[{'cui': 'C0018517', 'cui_str': 'Halflife'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",26.0,0.0212301,The difference between group 1 and group 4 was found significant (p = 0.002) with respect to days of hospital stay.,"[{'ForeName': 'Orhan', 'Initials': 'O', 'LastName': 'Altınboğa', 'Affiliation': 'Department of Obstetrics and Gynecology, Ankara City Hospital, Ankara, Turkey. orhanaltinboga@gmail.com.'}, {'ForeName': 'Betül', 'Initials': 'B', 'LastName': 'Yakıştıran', 'Affiliation': 'Department of Obstetrics and Gynecology, Ankara City Hospital, Ankara, Turkey.'}, {'ForeName': 'Seyit Ahmet', 'Initials': 'SA', 'LastName': 'Erol', 'Affiliation': 'Department of Obstetrics and Gynecology, Ankara City Hospital, Ankara, Turkey.'}, {'ForeName': 'Yüksel', 'Initials': 'Y', 'LastName': 'Oğuz', 'Affiliation': 'Department of Obstetrics and Gynecology, Ankara City Hospital, Ankara, Turkey.'}, {'ForeName': 'Batuhan', 'Initials': 'B', 'LastName': 'Bakırarar', 'Affiliation': 'Department of Statistics, Ankara University, Faculty of Medicine, Ankara, Turkey.'}, {'ForeName': 'Cavidan', 'Initials': 'C', 'LastName': 'Gülerman', 'Affiliation': 'Department of Obstetrics and Gynecology, Ankara City Hospital, Ankara, Turkey.'}, {'ForeName': 'Şevki', 'Initials': 'Ş', 'LastName': 'Çelen', 'Affiliation': 'Department of Obstetrics and Gynecology, Ankara City Hospital, Ankara, Turkey.'}, {'ForeName': 'Ali Turhan', 'Initials': 'AT', 'LastName': 'Çağlar', 'Affiliation': 'Department of Obstetrics and Gynecology, Ankara City Hospital, Ankara, Turkey.'}]",Archives of gynecology and obstetrics,['10.1007/s00404-020-05800-2']
2953,32989186,Effects of a Psychobiotic Supplement on Serum Brain-derived Neurotrophic Factor Levels in Depressive Patients: A  Post Hoc  Analysis of a Randomized Clinical Trial.,"Background/Aims


Psychobiotics are probiotics or prebiotics that, upon ingestion in adequate amounts, yield positive influence on mental health via microbiota-gut-brain axis regulation to modulate the circulating cytokines, chemokines, neurotransmitters, or neurotrophins levels. We have recently shown that a psychobiotic combination ( Lactobacillus helveticus  R0052 and  Bifidobacterium longum  R0175; CEREBIOME) significantly improved depression symptoms in patients with depression. Recent animal data suggest the influence of the gut microbiota on brain-derived neurotrophic factor (BDNF), which was shown to correlate with antidepressant response in depressive patients. Therefore, we conducted this exploratory  post hoc  analysis of BDNF levels to clarify the mechanism of action of this psychobiotic in our cohort.
Methods


Our study was a double-blind, randomized controlled trial of patients with low-to-moderate depression receiving either a probiotic combination, prebiotic or placebo. From the 110 patients randomized in the trial, 78 were included in this  post hoc  analysis (probiotic, n = 28; prebiotic and placebo, n = 25). We compared serum BDNF levels from participants at baseline and endpoint, and assessed the Pearson correlation between depression severity and BDNF levels for each intervention.
Results


We found that post-intervention BDNF levels were significantly different between groups ( P  < 0.001). Furthermore, BDNF levels increased significantly in the probiotic group compared to both the prebiotic ( P  < 0.001) and placebo groups ( P  = 0.021), which inversely correlated with depression severity compared to placebo (ANOVA/ANCOVA,  P  = 0.012; Pearson,  r  = -0.79,  P  < 0.001). In the prebiotic group, BDNF levels reduced but not significantly compared with placebo group ( P  > 0.05).
Conclusion


Eight-week supplementation with B. longum and L. helveticus in depressive patients improved depression symptoms, possibly by increasing BDNF levels.",2020,"In the prebiotic group, BDNF levels reduced but not significantly compared with placebo group ( P  > 0.05).
","['Depressive Patients', 'patients with depression', '110 patients randomized in the trial, 78 were included in this  post hoc  analysis (probiotic, n = 28; prebiotic and placebo, n = 25', 'depressive patients', 'patients with low-to-moderate depression receiving either a']","['probiotic combination, prebiotic or placebo', 'placebo', 'Psychobiotic Supplement']","['Serum Brain-derived Neurotrophic Factor Levels', 'BDNF levels', 'depression symptoms', 'depression severity', 'serum BDNF levels', 'post-intervention BDNF levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C2717875', 'cui_str': 'Prebiotics'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0588007', 'cui_str': 'Moderate depression'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C2717875', 'cui_str': 'Prebiotics'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",110.0,0.598531,"In the prebiotic group, BDNF levels reduced but not significantly compared with placebo group ( P  > 0.05).
","[{'ForeName': 'Nazanin', 'Initials': 'N', 'LastName': 'Heidarzadeh-Rad', 'Affiliation': 'Department of Nutrition and Dietetics, Hacettepe University Faculty of Health Sciences, Ankara, Turkey.'}, {'ForeName': 'Hülya', 'Initials': 'H', 'LastName': 'Gökmen-Özel', 'Affiliation': 'Department of Nutrition and Dietetics, Hacettepe University Faculty of Health Sciences, Ankara, Turkey.'}, {'ForeName': 'Asma', 'Initials': 'A', 'LastName': 'Kazemi', 'Affiliation': 'Nutrition Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Negin', 'Initials': 'N', 'LastName': 'Almasi', 'Affiliation': 'Department of Nutrition and Dietetics, Hacettepe University Faculty of Health Sciences, Ankara, Turkey.'}, {'ForeName': 'Kurosh', 'Initials': 'K', 'LastName': 'Djafarian', 'Affiliation': 'Department of Clinical Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran, Iran.'}]",Journal of neurogastroenterology and motility,['10.5056/jnm20079']
2954,32976501,"The impact of Worms and Ladders, an innovative health educational board game on Soil-Transmitted Helminthiasis control in Abeokuta, Southwest Nigeria.","In most endemic sub-Saharan African countries, repeated infections with soil-transmitted helminth (STH) occur as early as six weeks after the end of mass drug administration (MDA) with albendazole. In this study, we designed a new health educational board game Worms and Ladders and evaluated its potential to complement MDA with albendazole and reduce reinfection rates through the promotion of good hygiene practices among school-aged children. The evaluation employed a randomized control trial (RCT) design. Baseline knowledge, attitude and practices (KAP) relating to STH were obtained using a questionnaire from 372 pupils across six schools in Abeokuta, Nigeria. Schools were randomly assigned into intervention and control group, with the former and latter receiving Worms and Ladders and the common Snake and Ladder board game respectively. Fresh stool samples were also collected at baseline for STH diagnosis before administering 400mg single dose albendazole. Follow-up assessments of STH burden and KAP were conducted three and six months' post-intervention. Data generated from the study were analyzed using SPSS 20.0 software, with confidence interval set at 95%. Prevalence of STH dropped from 25.0% to 10.4% in the intervention group and 49.4% to 33.3% in the control group at three months' post-intervention. The prevalence further dropped to 5.6% in the intervention group at six months' post-intervention. However, it increased to 37.2% in the control group at six months' post-intervention. There was a significant difference (p<0.05) in prevalence after intervention among the groups. KAP on transmission, control and prevention of STH significantly improved (p<0.05) from 5.2% to 97.9% in the intervention group compared to 6.2% to 7.1% in the control group. The Worms and Ladders board game shows the potential to teach and promote good hygiene behavior among SAC. These findings posit the newly developed game as a reliable tool to complement mass drug administration campaigns for STH control.",2020,"KAP on transmission, control and prevention of STH significantly improved (p<0.05) from 5.2% to 97.9% in the intervention group compared to 6.2% to 7.1% in the control group.","['Soil-Transmitted Helminthiasis control in Abeokuta, Southwest Nigeria', 'school-aged children', '372 pupils across six schools in Abeokuta, Nigeria']","['albendazole', 'KAP']","['transmission, control and prevention of STH', 'Baseline knowledge, attitude and practices (KAP', 'Prevalence of STH', 'reinfection rates']","[{'cui': 'C0037592', 'cui_str': 'Soil'}, {'cui': 'C0242781', 'cui_str': 'Communicable Disease Transmission'}, {'cui': 'C0018889', 'cui_str': 'Helminth infection'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0028075', 'cui_str': 'Nigeria'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0034121', 'cui_str': 'Pupil structure'}]","[{'cui': 'C0001911', 'cui_str': 'Albendazole'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]","[{'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0037592', 'cui_str': 'Soil'}, {'cui': 'C0242781', 'cui_str': 'Communicable Disease Transmission'}, {'cui': 'C0018893', 'cui_str': 'Helminth'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0205339', 'cui_str': 'Reinfection'}]",,0.043445,"KAP on transmission, control and prevention of STH significantly improved (p<0.05) from 5.2% to 97.9% in the intervention group compared to 6.2% to 7.1% in the control group.","[{'ForeName': 'Dorcas B', 'Initials': 'DB', 'LastName': 'Bassey', 'Affiliation': 'Department of Pure and Applied Zoology, Federal University of Agriculture, Abeokuta, Ogun State, Nigeria.'}, {'ForeName': 'Hammed O', 'Initials': 'HO', 'LastName': 'Mogaji', 'Affiliation': 'Department of Animal and Environmental Biology, Federal University Oye-Ekiti, Ekiti State, Nigeria.'}, {'ForeName': 'Gabriel A', 'Initials': 'GA', 'LastName': 'Dedeke', 'Affiliation': 'Department of Pure and Applied Zoology, Federal University of Agriculture, Abeokuta, Ogun State, Nigeria.'}, {'ForeName': 'Bolanle I', 'Initials': 'BI', 'LastName': 'Akeredolu-Ale', 'Affiliation': 'Department of Communication and General Studies, Federal University of Agriculture, Abeokuta, Ogun State, Nigeria.'}, {'ForeName': 'Eniola M', 'Initials': 'EM', 'LastName': 'Abe', 'Affiliation': ""National Institute of Parasitic Disease and Control, China Centre for Disease Control, People's Republic of China.""}, {'ForeName': 'Akinola S', 'Initials': 'AS', 'LastName': 'Oluwole', 'Affiliation': 'COUNTDOWN project, Sightsavers, Nigeria Country Office, Nigeria.'}, {'ForeName': 'Abdulhakeem A', 'Initials': 'AA', 'LastName': 'Adeniran', 'Affiliation': 'Department of Pure and Applied Zoology, Federal University of Agriculture, Abeokuta, Ogun State, Nigeria.'}, {'ForeName': 'Olagunju A', 'Initials': 'OA', 'LastName': 'Agboola', 'Affiliation': 'Department of Pure and Applied Zoology, Federal University of Agriculture, Abeokuta, Ogun State, Nigeria.'}, {'ForeName': 'Chiedu F', 'Initials': 'CF', 'LastName': 'Mafiana', 'Affiliation': 'Directorate of Research and Innovation, National Open University of Nigeria, Abuja, Nigeria.'}, {'ForeName': 'Uwem F', 'Initials': 'UF', 'LastName': 'Ekpo', 'Affiliation': 'Department of Pure and Applied Zoology, Federal University of Agriculture, Abeokuta, Ogun State, Nigeria.'}]",PLoS neglected tropical diseases,['10.1371/journal.pntd.0008486']
2955,32976844,Microprocessor Controlled Knee Ankle Foot Orthosis (KAFO) vs Stance Control vs Locked KAFO: A Randomized Controlled Trial.,"OBJECTIVE


To evaluate the potential of a microprocessor swing and stance controlled knee-ankle-foot orthosis (MPO) to improve balance, functional mobility, and quality of life in individuals with lower-extremity impairments as compared to a stance-control-orthosis (SCO) and conventional knee-ankle-foot orthosis (KAFO) over a use-period of a month.
DESIGN


Randomized crossover study.
SETTING


Ambulatory research laboratory and home and community for community-dwelling adults.
PARTICIPANTS


Persons (N=18) who actively used a unilateral KAFO or SCO for impairments due to neurologic or neuromuscular disease, orthopedic disease, or trauma.
INTERVENTION


Participants were trained to acclimate and use SCO and MPO.
MAIN OUTCOME MEASURES


The 6-minute walk test (6MWT), 10-m walk test, Berg Balance Scale (BBS), functional gait assessment (FGA), hill assessment index, stair assessment index (SAI), Five Times Sit to Stand Test, crosswalk test, Modified Falls Efficacy Scale, Orthotic and Prosthetic User's Survey (OPUS), and World Health Organization Quality of Life (WHQOL)-BREF Scale.
RESULTS


Significant changes were observed in participants' self-selected gait speed (P=.023), BBS (P=.01), FGA (P=.002), and SAI (P<.001) between baseline and post-MPO assessment. Similar significant differences were seen when comparing post-MPO with post-SCO data. During the 6MWT, persons using the MPO walked significantly longer (P=.013) than when using their baseline device. Participants reported higher quality of life scores in the OPUS (P=.02) and physical health domain of the WHOQOL-BREF (P=.037) after using the MPO. Participants reported fewer falls when wearing the MPO (5) versus an SCO (38) or locked KAFO (15).
CONCLUSIONS


The MPO may contribute to improved quality of life and health status of persons with lower-extremity impairments by providing the ability to have better walking speed, endurance, and functional balance.",2020,Participants reported higher quality of life scores in the OPUS (p=0.02) and physical health domain of the WHOQOL-BREF (p=0.037) after using the MPO.,"['individuals with lower-extremity impairments', 'Eighteen persons who actively use a unilateral KAFO or SCO for impairments due to neurological or neuromuscular disease, orthopedic disease, or trauma', 'Ambulatory research lab and home and community for community dwelling adults']","['stance-control-orthosis (SCO) and conventional knee-ankle-foot orthosis (KAFO', 'microprocessor swing and stance controlled knee-ankle-foot orthosis (MPO', 'Microprocessor Controlled Knee Ankle Foot Orthosis (KAFO) vs. Stance Control vs. Locked KAFO']","['6 Minute Walk Test (6MWT), 10 Meter Walk Test (10MWT), Berg Balance Scale (BBS), Functional Gait Assessment (FGA), Hill Assessment Index (HAI), Stair Assessment Index (SAI', 'balance, functional mobility, and quality of life', 'physical health domain of the WHOQOL-BREF', ""participants' self-selected gait speed"", ""5 Times Sit to Stand Test (5xSST), Cross Walk Test, Modified Falls Efficacy Scale (mFES), Orthotic and Prosthetic User's Survey (OPUS), World Health Organization Quality of Life - Brief Scale (WHOQOL-BREF"", 'quality of life and health status', 'quality of life scores', 'BBS']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0438868', 'cui_str': 'Knee-ankle-foot orthosis'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0006086', 'cui_str': 'Brace'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0027868', 'cui_str': 'Myoneural disorder'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0006086', 'cui_str': 'Brace'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0438868', 'cui_str': 'Knee-ankle-foot orthosis'}, {'cui': 'C0026012', 'cui_str': 'Microprocessors'}, {'cui': 'C0027021', 'cui_str': 'Peroxidase'}, {'cui': 'C0231753', 'cui_str': 'Knee locking'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C1283250', 'cui_str': 'Foot orthosis'}]","[{'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0442532', 'cui_str': 'Hill'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0029365', 'cui_str': 'Orthotic device'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.040921,Participants reported higher quality of life scores in the OPUS (p=0.02) and physical health domain of the WHOQOL-BREF (p=0.037) after using the MPO.,"[{'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Deems-Dluhy', 'Affiliation': 'Max Näder Lab for Rehabilitation Technologies & Outcomes Lab, Shirley Ryan AbilityLab (formerly the Rehabilitation Institute of Chicago), Chicago, IL; Center for Bionic Medicine, Shirley Ryan AbilityLab, Chicago, IL.'}, {'ForeName': 'Shenan', 'Initials': 'S', 'LastName': 'Hoppe-Ludwig', 'Affiliation': 'Max Näder Lab for Rehabilitation Technologies & Outcomes Lab, Shirley Ryan AbilityLab (formerly the Rehabilitation Institute of Chicago), Chicago, IL; Center for Bionic Medicine, Shirley Ryan AbilityLab, Chicago, IL.'}, {'ForeName': 'Chaithanya K', 'Initials': 'CK', 'LastName': 'Mummidisetty', 'Affiliation': 'Max Näder Lab for Rehabilitation Technologies & Outcomes Lab, Shirley Ryan AbilityLab (formerly the Rehabilitation Institute of Chicago), Chicago, IL; Center for Bionic Medicine, Shirley Ryan AbilityLab, Chicago, IL.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Semik', 'Affiliation': 'Center for Rehabilitation Outcomes Research, Shirley Ryan AbilityLab, Chicago, IL.'}, {'ForeName': 'Allen W', 'Initials': 'AW', 'LastName': 'Heinemann', 'Affiliation': 'Center for Rehabilitation Outcomes Research, Shirley Ryan AbilityLab, Chicago, IL; Department of Physical Medicine and Rehabilitation, Feinberg School of Medicine, Northwestern University, Chicago, IL.'}, {'ForeName': 'Arun', 'Initials': 'A', 'LastName': 'Jayaraman', 'Affiliation': 'Max Näder Lab for Rehabilitation Technologies & Outcomes Lab, Shirley Ryan AbilityLab (formerly the Rehabilitation Institute of Chicago), Chicago, IL; Center for Bionic Medicine, Shirley Ryan AbilityLab, Chicago, IL; Department of Physical Medicine and Rehabilitation, Feinberg School of Medicine, Northwestern University, Chicago, IL. Electronic address: ajayaraman@sralab.org.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.08.013']
2956,32976869,Phase 1 trial of ralimetinib (LY2228820) with radiotherapy plus concomitant temozolomide in the treatment of newly diagnosed glioblastoma.,"BACKGROUND AND PURPOSE


This phase 1 trial aimed to determine the maximum tolerated dose (MTD; primary objective) of a p38-MAPK inhibitor, ralimetinib, with radiotherapy (RT) and chemotherapy (TMZ), in the treatment of newly diagnosed glioblastoma (GBM) patients.
MATERIALS AND METHODS


The study was designed as an open-label dose-escalation study driven by a Tite-CRM design and followed by an expansion cohort. Ralimetinib was administered orally every 12 h, 7 days a week, for 2 cycles of 2 weeks at a dose of 100, 200 or 300 mg/12 h. Patients received ralimetinib added to standard concurrent RT (60 Gy in 30 fractions) with TMZ (75 mg/m 2 /day) and 6 cycles of adjuvant TMZ (150-200 mg/m 2  on days 1-5 every 28 days).
RESULTS


The MTD of ralimetinib was 100 mg/12 h with chemoradiotherapy. The three patients treated at 200 mg/12 h presented a dose-limiting toxicity: one patient had a grade 3 face edema, and two patients had a grade 3 rash and grade 3 hepatic cytolysis (66%). Of the 18 enrolled patients, 15 received the MTD of ralimetinib. At the MTD, the grade ≥ 3 adverse events during concomitant chemoradiotherapy were hepatic cytolysis (2/15 patients), dermatitis/rash (1/15), lymphopenia (1/15) and nausea/vomiting (1/15). No interaction of TMZ and ralimetinib when administrated concomitantly has been observed. Inhibition of pMAPKAP-K2 (-54%) was observed in peripheral blood mononuclear cells.
CONCLUSION


This phase 1 trial is the first trial to study the combination of a p38-MAPK inhibitor, ralimetinib, with radiotherapy (RT) and chemotherapy (TMZ), in the treatment of newly diagnosed glioblastoma (GBM) patients. The MTD of ralimetinib was 100 mg/12 h. The most frequent dose-limiting toxicities were hepatic cytolysis and rash.",2020,No interaction of TMZ and ralimetinib when administrated concomitantly has been observed.,"['18 enrolled patients, 15 received the MTD of ralimetinib', 'newly diagnosed glioblastoma', 'newly diagnosed glioblastoma (GBM) patients']","['adjuvant TMZ', 'TMZ', 'ralimetinib added to standard concurrent RT', 'Ralimetinib', 'p38-MAPK inhibitor, ralimetinib, with radiotherapy (RT) and chemotherapy (TMZ', 'ralimetinib (LY2228820) with radiotherapy plus concomitant temozolomide']","['peripheral blood mononuclear cells', 'lymphopenia (1/15) and nausea/vomiting', 'dermatitis/rash', 'grade 3 rash and grade 3 hepatic cytolysis']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0752079', 'cui_str': 'Maximal Tolerated Dose'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0017636', 'cui_str': 'Glioblastoma'}]","[{'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0076080', 'cui_str': 'temozolomide'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0257535', 'cui_str': 'CSAID-Binding Protein'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}]","[{'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C0024312', 'cui_str': 'Lymphocytopenia'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0011603', 'cui_str': 'Dermatitis'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0151763', 'cui_str': 'Liver damage'}]",18.0,0.0623238,No interaction of TMZ and ralimetinib when administrated concomitantly has been observed.,"[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Biau', 'Affiliation': 'Radiation Department, Centre Jean Perrin, Clermont-Ferrand, France; University of Clermont Auvergne, UFR Médecine, Clermont-Ferrand, France; INSERM U1240 IMoST, University of Clermont Auvergne, Clermont-Ferrand, France. Electronic address: Julian.biau@clermont.unicancer.fr.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Thivat', 'Affiliation': ""University of Clermont Auvergne, UFR Médecine, Clermont-Ferrand, France; INSERM U1240 IMoST, University of Clermont Auvergne, Clermont-Ferrand, France; Centre d'Investigation Clinique UMR 501, Clermont-Ferrand, France.""}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Chautard', 'Affiliation': 'University of Clermont Auvergne, UFR Médecine, Clermont-Ferrand, France; Department of Clinical Research, Délégation Recherche Clinique et Innovation, Centre Jean Perrin, Clermont-Ferrand, France.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Stefan', 'Affiliation': 'Pathology Department, Centre Jean Perrin, Clermont-Ferrand, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Boone', 'Affiliation': 'Radiation Oncology Department, Centre François Baclesse, Caen, France.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Chauffert', 'Affiliation': 'Radiation Oncology Department, Centre François Baclesse, Caen, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Bourgne', 'Affiliation': 'Department of Medical Oncology, CHU Amiens, Amiens Cedex 1, France.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Richard', 'Affiliation': 'Department of Biologic Hematology, CHU Estaing, Clermont-Ferrand Cedex 1, France.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Molna', 'Affiliation': ""University of Clermont Auvergne, UFR Médecine, Clermont-Ferrand, France; INSERM U1240 IMoST, University of Clermont Auvergne, Clermont-Ferrand, France; Centre d'Investigation Clinique UMR 501, Clermont-Ferrand, France.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Levesque', 'Affiliation': ""University of Clermont Auvergne, UFR Médecine, Clermont-Ferrand, France; INSERM U1240 IMoST, University of Clermont Auvergne, Clermont-Ferrand, France; Centre d'Investigation Clinique UMR 501, Clermont-Ferrand, France.""}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Bellini', 'Affiliation': 'CHU Clermont-Ferrand, University of Clermont-Auvergne, Medical Pharmacology Department, UMR INSERM, 1107 Neuro-Dol, Clermont-Ferrand, France.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Kwiatkowski', 'Affiliation': ""University of Clermont Auvergne, UFR Médecine, Clermont-Ferrand, France; INSERM U1240 IMoST, University of Clermont Auvergne, Clermont-Ferrand, France; Centre d'Investigation Clinique UMR 501, Clermont-Ferrand, France.""}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Karayan-Tapon', 'Affiliation': 'Radiodiagnostic Department, Centre Jean-Perrin, Clermont-Ferrand, France.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Verrelle', 'Affiliation': 'Radiation Department, Centre Jean Perrin, Clermont-Ferrand, France; University of Poitiers, INSERMU1084, CHU de Poitiers, Department of Cancer Biology, Poitiers, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Godfraind', 'Affiliation': 'Department of Radiation Oncology, Institut Curie, Paris, France.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Durando', 'Affiliation': ""University of Clermont Auvergne, UFR Médecine, Clermont-Ferrand, France; INSERM U1240 IMoST, University of Clermont Auvergne, Clermont-Ferrand, France; Centre d'Investigation Clinique UMR 501, Clermont-Ferrand, France; Department of Pathological Anatomy, CHU de Clermont-Ferrand, Clermont-Ferrand, France.""}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2020.09.036']
2957,32977221,Concordance between CA-125 and RECIST progression in patients with germline BRCA-mutated platinum-sensitive relapsed ovarian cancer treated in the SOLO2 trial with olaparib as maintenance therapy after response to chemotherapy.,"BACKGROUND


Limited evidence exists to support CA-125 as a valid surrogate biomarker for progression in patients with ovarian cancer on maintenance PARP inhibitor (PARPi) therapy. We aimed to assess the concordance between CA-125 and Response Evaluation Criteria in Solid Tumours (RECIST) criteria for progression in patients with BRCA mutations on maintenance PARPi or placebo.
METHODS


We extracted data on progression as defined by Gynecologic Cancer InterGroup CA-125, investigator- and independent central-assessed RECIST from the SOLO2/ENGOT-ov21(NCT01874353) trial. We excluded those with progression other than by RECIST, progression on date of randomisation, and no repeat CA-125 beyond baseline. We evaluated the concordance between CA-125 progression and RECIST progression, and assessed the negative (NPV) and positive predictive value (PPV).
RESULTS


Of 295 randomised patients, 275 (184 olaparib, 91 placebo) were included. 171 patients had investigator-assessed RECIST progression. Of 80 patients with CA-125 progression, 77 had concordant RECIST progression (PPV 96%, 95% confidence interval 90-99%). Of 195 patients without CA-125 progression, 94 had RECIST progression (NPV 52%, 45-59%). Within treatment arms, PPV was similar (olaparib: 95% [84-99%], placebo: 97% [87-100%]) but NPV was lower in patients on placebo (olaparib: 60% [52-68%], placebo: 30% [20-44%]). Of 94 patients with RECIST but without CA-125 progression, 64 (68%) had CA-125 that remained within normal range. We observed similar findings using independent-assessed RECIST.
CONCLUSIONS


Almost half the patients without CA-125 progression had RECIST progression, and most of these had CA-125 within the normal range. Regular computed tomography imaging should be considered as part of surveillance in patients treated with or without maintenance olaparib rather than relying on CA-125 alone.",2020,"Within treatment arms, PPV was similar (olaparib: 95% [84-99%], placebo: 97% [87-100%]) but NPV was lower in patients on placebo (olaparib: 60% [52-68%], placebo: 30% [20-44%]).","['patients with BRCA mutations on maintenance PARPi or placebo', 'patients treated with or without maintenance olaparib rather than relying on CA-125 alone', '295 randomised patients, 275 (184 olaparib, 91', 'patients with ovarian cancer on maintenance PARP inhibitor (PARPi) therapy', '171 patients had investigator-assessed RECIST progression', 'patients with germline BRCA-mutated platinum-sensitive relapsed ovarian cancer']","['placebo', 'Regular computed tomography imaging']","['PPV', 'RECIST progression', 'CA-125 progression and RECIST progression, and assessed the negative (NPV) and positive predictive value (PPV', 'concordant RECIST progression']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C1882413', 'cui_str': 'Nicotinamide adenine dinucleotide adenosine diphosphate ribosyltransferase inhibitor-containing product'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C2316164', 'cui_str': 'olaparib'}, {'cui': 'C0006610', 'cui_str': 'Cancer antigen 125'}, {'cui': 'C4517676', 'cui_str': '275'}, {'cui': 'C4517616', 'cui_str': '184'}, {'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0278689', 'cui_str': 'Recurrent ovarian cancer'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0729619', 'cui_str': 'Computed tomography imaging - action'}]","[{'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0006610', 'cui_str': 'Cancer antigen 125'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",80.0,0.112487,"Within treatment arms, PPV was similar (olaparib: 95% [84-99%], placebo: 97% [87-100%]) but NPV was lower in patients on placebo (olaparib: 60% [52-68%], placebo: 30% [20-44%]).","[{'ForeName': 'Angelina', 'Initials': 'A', 'LastName': 'Tjokrowidjaja', 'Affiliation': 'National Health and Medical Research Council Clinical Trials Centre, The University of Sydney, Sydney, NSW 2050, Australia; Department of Medical Oncology, St George Hospital, Kogarah, NSW 2217, Australia. Electronic address: angelina.tjokrowidjaja@ctc.usyd.edu.au.'}, {'ForeName': 'Chee K', 'Initials': 'CK', 'LastName': 'Lee', 'Affiliation': 'National Health and Medical Research Council Clinical Trials Centre, The University of Sydney, Sydney, NSW 2050, Australia; Department of Medical Oncology, St George Hospital, Kogarah, NSW 2217, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Friedlander', 'Affiliation': 'Department of Medical Oncology, Prince of Wales Hospital, Randwick, NSW 2031, Australia.'}, {'ForeName': 'Val', 'Initials': 'V', 'LastName': 'Gebski', 'Affiliation': 'National Health and Medical Research Council Clinical Trials Centre, The University of Sydney, Sydney, NSW 2050, Australia.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Gladieff', 'Affiliation': 'Department of Medical Oncology, Institut Claudius Regaud, IUCT-Oncopole, 31059 Toulouse, France.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Ledermann', 'Affiliation': 'UCL Cancer Institute, University College London, London WC1E 6DD, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Penson', 'Affiliation': 'Division of Hematology and Oncology, Massachusetts General Hospital, Boston, MA 02114, USA.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Oza', 'Affiliation': 'Princess Margaret Cancer Centre, University Health Network, University of Toronto, Toronto, ON M5G 2C1, Canada.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Korach', 'Affiliation': 'Gynecologic Oncology Department, Sheba Medical Center, Sackler School of Medicine, Tel Aviv University, 52621 Tel Aviv, Israel.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Huzarski', 'Affiliation': 'Department of Genetics and Pathology, Pomeranian Medical University, 70-204 Szczecin, Poland.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Manso', 'Affiliation': 'Hospital 12 de Octubre, 28041 Madrid, Spain.'}, {'ForeName': 'Carmela', 'Initials': 'C', 'LastName': 'Pisano', 'Affiliation': 'Department of Urogynecology, National Cancer Institute, Pascale Foundation (Scientific Institute for Research and Healthcare), 80131 Naples, Italy.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Asher', 'Affiliation': 'National Health and Medical Research Council Clinical Trials Centre, The University of Sydney, Sydney, NSW 2050, Australia.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Lord', 'Affiliation': 'National Health and Medical Research Council Clinical Trials Centre, The University of Sydney, Sydney, NSW 2050, Australia; School of Medicine, The University of Notre Dame, Sydney, NSW 2007, Australia.'}, {'ForeName': 'Se Ik', 'Initials': 'SI', 'LastName': 'Kim', 'Affiliation': 'Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul 03080, South Korea.'}, {'ForeName': 'Jung-Yun', 'Initials': 'JY', 'LastName': 'Lee', 'Affiliation': ""Department of Obstetrics and Gynecology, Institute of Women's Life Medical Science, Yonsei University College of Medicine, Seoul, South Korea.""}, {'ForeName': 'Nicoletta', 'Initials': 'N', 'LastName': 'Colombo', 'Affiliation': 'Gynecology Program, European Institute of Oncology, IRCCS, 20141 Milan, Italy; School of Medicine and Surgery, University Milan Bicocca, 20126 Milan, Italy.'}, {'ForeName': 'Tjoung-Won', 'Initials': 'TW', 'LastName': 'Park-Simon', 'Affiliation': 'Department of Gynaecology and Obstetrics, Medical University Hannover, 30625 Hannover, Germany.'}, {'ForeName': 'Keiichi', 'Initials': 'K', 'LastName': 'Fujiwara', 'Affiliation': 'Department of Gynecologic Oncology, Saitama Medical University International Medical Center, Saitama 350-0495, Japan.'}, {'ForeName': 'Gabe', 'Initials': 'G', 'LastName': 'Sonke', 'Affiliation': 'Department of Medical Oncology, Netherlands Cancer Institute, 1066 CX Amsterdam, the Netherlands.'}, {'ForeName': 'Ignace', 'Initials': 'I', 'LastName': 'Vergote', 'Affiliation': 'Department of Oncology, KU Leuven - University of Leuven, B-3000 Leuven, Belgium; Division of Gynaecological Oncology, University Hospitals Leuven, B-3000 Leuven, Belgium.'}, {'ForeName': 'Jae-Weon', 'Initials': 'JW', 'LastName': 'Kim', 'Affiliation': 'Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul 03080, South Korea.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Pujade-Lauraine', 'Affiliation': 'Université Paris Descartes, Paris, France; ARCAGY-GINECO, France.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.08.021']
2958,32977252,Skim milk as a recovery beverage after exercise is superior to a sports drink for reducing next-day postprandial blood glucose and increasing postprandial fat oxidation.,"We determined the effect of consuming low-glycemic index (LGI) skim milk compared to a high-glycemic index (HGI) sports drink following evening exercise on fat oxidation and blood lipids after a subsequent high-energy breakfast. We hypothesized that postexercise skim milk consumption, compared to sports drink, would increase fat oxidation and lower harmful blood lipid and glucose concentrations after a next-day high-energy breakfast. In this randomized counterbalanced crossover trial, 20 overweight-obese participants (body mass index ≥ 25 kg/m 2 ) underwent 4 conditions: 90-minute exercise (50% Vo 2peak ) followed by sports drink (EX-HGI), exercise followed by isoenergetic skim milk (EX-LGI), exercise followed by water (Exercise), and a control condition (Control). The amount of the sports drink or milk consumed postexercise was based on the energy used during exercise plus 10%. Blood lipids, glucose, and fat oxidation were assessed before and for 6 hours after a high-energy breakfast the next morning. Fat oxidation was highest for EX-LGI (6.7 ± 2.7 g/h) and lowest for EX-HGI (6.0 ± 1.8 g/h) (condition main effect; P = .042). Triglyceride concentration and total area under the curve were higher with EX-HGI than Exercise (1.7 ± 1.6 vs 1.3 ± 1.0 mmol/L, P = .037, and 11.7 ± 9.4 vs 8.6 ± 6.0 mmol L -1  h, P = .005, respectively). Glucose concentration was lower with EX-LGI than EX-HGI (4.1 ± 1.1 vs 4.4 ± 1.1 mmol/L, P = .027). Homeostatic model assessment of insulin resistance was higher with EX-HGI than Control (2.32 ± 1.15 vs 1.86 ± 0.97, P = .005). In conclusion, evening postexercise skim milk consumption, compared with a high-GI sports drink, significantly reduced blood glucose and possibly increased fat oxidation after a high-energy breakfast the next morning.",2020,"Homeostatic model assessment of insulin resistance was higher with EX-HGI than Control (2.32 ± 1.15 vs 1.86 ± 0.97, P = .005).",['20 overweight-obese participants (body mass index ≥\u202f25\u202fkg/m 2 ) underwent'],"['consuming low-glycemic index (LGI) skim milk', '4 conditions: 90-minute exercise (50% Vo 2peak ) followed by sports drink (EX-HGI), exercise followed by isoenergetic skim milk (EX-LGI), exercise followed by water (Exercise), and a control condition (Control', 'Skim milk']","['blood glucose', 'fat oxidation', 'fat oxidation and lower harmful blood lipid and glucose concentrations', 'Glucose concentration', 'Fat oxidation', 'Triglyceride concentration and total area under the curve', 'Blood lipids, glucose, and fat oxidation', 'fat oxidation and blood lipids', 'Homeostatic model assessment of insulin resistance']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1136206', 'cui_str': 'Glycemic Index Number'}, {'cui': 'C0349375', 'cui_str': 'Skim milk'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0452461', 'cui_str': 'Sports drink'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0427743', 'cui_str': 'Glucose concentration, test strip measurement'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}]",20.0,0.0207451,"Homeostatic model assessment of insulin resistance was higher with EX-HGI than Control (2.32 ± 1.15 vs 1.86 ± 0.97, P = .005).","[{'ForeName': 'Ruirui', 'Initials': 'R', 'LastName': 'Gao', 'Affiliation': 'College of Kinesiology, University of Saskatchewan, Saskatoon, Saskatchewan, Canada S7N 5B2; Sport Science College, Beijing Sport University, Beijing 100084, China. Electronic address: ruirui.gao@usask.ca.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Rapin', 'Affiliation': 'College of Kinesiology, University of Saskatchewan, Saskatoon, Saskatchewan, Canada S7N 5B2. Electronic address: nicole.rapin@usask.ca.'}, {'ForeName': 'Abdulrahman M', 'Initials': 'AM', 'LastName': 'Elnajmi', 'Affiliation': 'College of Kinesiology, University of Saskatchewan, Saskatoon, Saskatchewan, Canada S7N 5B2. Electronic address: abe823@mail.usask.ca.'}, {'ForeName': 'Julianne', 'Initials': 'J', 'LastName': 'Gordon', 'Affiliation': 'College of Kinesiology, University of Saskatchewan, Saskatoon, Saskatchewan, Canada S7N 5B2. Electronic address: julianne.rooke@usask.ca.'}, {'ForeName': 'Gordon A', 'Initials': 'GA', 'LastName': 'Zello', 'Affiliation': 'College of Pharmacy and Nutrition, University of Saskatchewan, Saskatoon, Saskatchewan, Canada S7N 5E5. Electronic address: gaz511@campus.usask.ca.'}, {'ForeName': 'Philip D', 'Initials': 'PD', 'LastName': 'Chilibeck', 'Affiliation': 'College of Kinesiology, University of Saskatchewan, Saskatoon, Saskatchewan, Canada S7N 5B2. Electronic address: phil.chilibeck@usask.ca.'}]","Nutrition research (New York, N.Y.)",['10.1016/j.nutres.2020.08.007']
2959,32977253,Beneficial effect of l-arginine in women using assisted reproductive technologies: a small-scale randomized controlled trial.,"This small-scale randomized controlled study aimed to examine the effect of l-arginine supplementation on the human chorionic gonadotropin (hCG)-positive rate and clinical pregnancy rate (CPR) in women undergoing assisted reproductive technology (ART) treatment for 3 months. From November 2017 to March 2018, 120 patients aged less than 40 years and planning for egg retrieval for embryo transfer were enrolled. The patients were divided into the AS2000 group (n = 36; l-arginine, 2 g; folate, 400 μg; and vitamin E, 10 mg), AS1000 group (n = 37; l-arginine, 1 g; and folate, 200 μg), and control group (n = 36). The main outcome was the hCG-positive rate or CPR in 3 months. The cumulative hCG-positive rates during the administration period were 44.2%, 54.2%, and 52.1%, and the CPRs were 39.5%, 41.7%, and 47.9% in the control, AS1000, and AS2000 groups, respectively. Odds ratios of the hCG-positive rate and CPR in the global l-arginine group (AS1000 and AS2000) versus those in the control group were 1.33 (95% confidence interval [CI], 0.62-2.90) and 1.11 (95% CI, 0.51-2.46), respectively. In the subgroup of women receiving ART because of male infertility, the hCG-positive rate and CPR were significantly increased in the l-arginine groups compared to those in the control group (13.42 [95% CI, 1.42-366.9] and 13.62 (95% CI, 1.42-367.6), respectively). Thus, arginine supplementation may be an option for women who desire pregnancy, especially those undergoing an ART program because of male infertility.",2020,"In the subgroup of women receiving ART because of male infertility, the hCG-positive rate and CPR were significantly increased in the l-arginine groups compared to those in the control group (13.42 [95% CI, 1.42-366.9] and 13.62 (95% CI, 1.42-367.6), respectively).","['women who desire pregnancy, especially those undergoing an ART program because of male infertility', 'From November 2017 to March 2018, 120 patients aged less than 40 years and planning for egg retrieval for embryo transfer were enrolled', 'women undergoing assisted reproductive technology (ART) treatment for 3 months', 'women using assisted reproductive technologies']","['l-arginine', 'AS2000 group (n\u202f=\u202f36; l-arginine, 2 g; folate, 400 μg; and vitamin E', 'arginine supplementation', 'l-arginine supplementation']","['cumulative hCG-positive rates', 'human chorionic gonadotropin (hCG)-positive rate and clinical pregnancy rate (CPR', 'CPRs', 'hCG-positive rate or CPR', 'hCG-positive rate and CPR', 'Odds ratios of the hCG-positive rate and CPR']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0035157', 'cui_str': 'Reproductive Technologies'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0021364', 'cui_str': 'Male infertility'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0013710', 'cui_str': 'Eggs (edible)'}, {'cui': 'C0013938', 'cui_str': 'Embryo transfer'}, {'cui': 'C0872104', 'cui_str': 'Assisted reproductive technology'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C3203517', 'cui_str': 'Human chorionic gonadotropin positive'}, {'cui': 'C0428402', 'cui_str': 'Human chorionic gonadotropin measurement'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}]",120.0,0.311347,"In the subgroup of women receiving ART because of male infertility, the hCG-positive rate and CPR were significantly increased in the l-arginine groups compared to those in the control group (13.42 [95% CI, 1.42-366.9] and 13.62 (95% CI, 1.42-367.6), respectively).","[{'ForeName': 'Shuhei', 'Initials': 'S', 'LastName': 'So', 'Affiliation': 'Department of Reproductive and Perinatal Medicine, Hamamatsu University School of Medicine, 1-20-1 Handayama, Higashi-ku, Hamamatsu-shi, Shizuoka 431-3192, Japan; Tawara IVF clinic, 2-20, Izumi-cho, Suruga-ku Shizuoka-shi, Shizuoka 422-8066, Japan. Electronic address: so@hama-med.ac.jp.'}, {'ForeName': 'Wakasa', 'Initials': 'W', 'LastName': 'Yamaguchi', 'Affiliation': 'Tawara IVF clinic, 2-20, Izumi-cho, Suruga-ku Shizuoka-shi, Shizuoka 422-8066, Japan.'}, {'ForeName': 'Nao', 'Initials': 'N', 'LastName': 'Murabayashi', 'Affiliation': 'Department of Reproductive and Perinatal Medicine, Hamamatsu University School of Medicine, 1-20-1 Handayama, Higashi-ku, Hamamatsu-shi, Shizuoka 431-3192, Japan; Tawara IVF clinic, 2-20, Izumi-cho, Suruga-ku Shizuoka-shi, Shizuoka 422-8066, Japan.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Miyano', 'Affiliation': 'Tawara IVF clinic, 2-20, Izumi-cho, Suruga-ku Shizuoka-shi, Shizuoka 422-8066, Japan.'}, {'ForeName': 'Fumiko', 'Initials': 'F', 'LastName': 'Tawara', 'Affiliation': 'Tawara IVF clinic, 2-20, Izumi-cho, Suruga-ku Shizuoka-shi, Shizuoka 422-8066, Japan.'}, {'ForeName': 'Naohiro', 'Initials': 'N', 'LastName': 'Kanayama', 'Affiliation': 'Tawara IVF clinic, 2-20, Izumi-cho, Suruga-ku Shizuoka-shi, Shizuoka 422-8066, Japan; Department of Obstetrics and Gynecology, Hamamatsu University School of Medicine, 1-20-1 Handayama, Higashi-ku, Hamamatsu-shi, Shizuoka 431-3192, Japan.'}]","Nutrition research (New York, N.Y.)",['10.1016/j.nutres.2020.08.008']
2960,32977254,"Low anthocyanin plum nectar does not impact cognition, blood pressure and gut microbiota in healthy older adults: A randomized crossover trial.","Queen Garnet plum (QGP), known for its high levels of anthocyanins, is a hybrid of the Japanese plum developed in Queensland, Australia. Anthocyanins provide the red, blue, and purple pigments in plants with demonstrated beneficial health effects. This study hypothesized that low-dose anthocyanin QGP intake will have a significant positive effect on cognition, blood pressure, and gut microbiota in healthy older adults. A randomized crossover trial was conducted to determine the effect and within subject variance on cognition and 24 hr. ambulatory blood pressure in older adults without cognitive impairment following daily consumption of 200 mL low-dose anthocyanin (5 mg/100 g) QGP nectar (intervention) or raspberry cordial (control). Secondary outcomes included inflammatory markers (C-reactive protein), nerve growth factor (BDNF), and gut microbiota (16S rRNA gene sequencing). Twenty-eight participants (55+ years) were recruited. Each randomized treatment arm lasted for 8 weeks with a 4-week washout period. Cognition, blood pressure, and urine samples were measured at each visit (5 total) while blood and fecal samples were collected at baseline, 8 weeks, and 20 weeks. Repeated-measures ANOVA was used to analyze the data. Across the treatments, no significant difference was observed for the different domains of cognition, blood pressure, or anti-inflammatory biomarkers. No intervention effect was found for genera or class of gut microbes. Low anthocyanin nectar derived from the QGP did not have any significant effects on cognition, blood pressure, or gut microbiota in healthy older adults.",2020,"Across the treatments, no significant difference was observed for the different domains of cognition, blood pressure, or anti-inflammatory biomarkers.","['older adults without cognitive impairment following', 'Twenty-eight participants (55+ years) were recruited', 'healthy older adults']","['Queen Garnet plum (QGP', 'daily consumption of 200 mL low-dose anthocyanin (5 mg/100 g) QGP nectar (intervention) or raspberry cordial (control', 'anthocyanin QGP intake', 'Low anthocyanin plum nectar']","['genera or class of gut microbes', 'cognition, blood pressure, or anti-inflammatory biomarkers', 'cognition, blood pressure, and gut microbiota', 'blood pressure and gut microbiota', 'inflammatory markers (C-reactive protein), nerve growth factor (BDNF), and gut microbiota (16S rRNA gene sequencing', 'cognition, blood pressure, or gut microbiota', 'ambulatory blood pressure', 'Cognition, blood pressure, and urine samples']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0330660', 'cui_str': 'Prunus domestica'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0003161', 'cui_str': 'Anthocyanin'}, {'cui': 'C2717960', 'cui_str': 'Nectar'}, {'cui': 'C0453292', 'cui_str': 'Raspberries'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0205251', 'cui_str': 'Low'}]","[{'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0027752', 'cui_str': 'Nerve Growth Factor'}, {'cui': 'C0035899', 'cui_str': 'Ribosomal RNA Genes'}, {'cui': 'C0162801', 'cui_str': 'Analysis, Sequence'}, {'cui': 'C0855316', 'cui_str': 'Blood pressure ambulatory'}, {'cui': 'C1610733', 'cui_str': 'Urine specimen'}]",,0.0441453,"Across the treatments, no significant difference was observed for the different domains of cognition, blood pressure, or anti-inflammatory biomarkers.","[{'ForeName': 'Ezinne O', 'Initials': 'EO', 'LastName': 'Igwe', 'Affiliation': 'School of Medicine, University of Wollongong, Wollonggong, NSW, Australia; Illawarra Health and Medical Research Institute, University of Wollongong, Wollonggong, NSW, Australia. Electronic address: ekorie@uow.edu.au.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Roodenrys', 'Affiliation': 'School of Psychology, University of Wollongong, Wollonggong, NSW, Australia.'}, {'ForeName': 'Yasmine C', 'Initials': 'YC', 'LastName': 'Probst', 'Affiliation': 'School of Medicine, University of Wollongong, Wollonggong, NSW, Australia; Illawarra Health and Medical Research Institute, University of Wollongong, Wollonggong, NSW, Australia.'}, {'ForeName': 'Vinicius', 'Initials': 'V', 'LastName': 'do Rosario', 'Affiliation': 'School of Medicine, University of Wollongong, Wollonggong, NSW, Australia; Illawarra Health and Medical Research Institute, University of Wollongong, Wollonggong, NSW, Australia.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Netzel', 'Affiliation': 'Queensland Alliance for Agriculture and Food Innovation, The University of Queensland, Coopers Plains, QLD 4108, Australia.'}, {'ForeName': 'Hung T', 'Initials': 'HT', 'LastName': 'Hong', 'Affiliation': 'Queensland Alliance for Agriculture and Food Innovation, The University of Queensland, Coopers Plains, QLD 4108, Australia.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Netzel', 'Affiliation': 'Queensland Alliance for Agriculture and Food Innovation, The University of Queensland, Coopers Plains, QLD 4108, Australia.'}, {'ForeName': 'Anh D T', 'Initials': 'ADT', 'LastName': 'Phan', 'Affiliation': 'Queensland Alliance for Agriculture and Food Innovation, The University of Queensland, Coopers Plains, QLD 4108, Australia.'}, {'ForeName': 'Karen E', 'Initials': 'KE', 'LastName': 'Charlton', 'Affiliation': 'School of Medicine, University of Wollongong, Wollonggong, NSW, Australia; Illawarra Health and Medical Research Institute, University of Wollongong, Wollonggong, NSW, Australia.'}]","Nutrition research (New York, N.Y.)",['10.1016/j.nutres.2020.08.003']
2961,32979515,A dyadic approach for a remote physical activity intervention in adults with Alzheimer's disease and their caregivers: Rationale and design for an 18-month randomized trial.,"Adults with Alzheimer's disease and related dementia (ADRD) and their caregivers represent a sizeable and underserved segment of the population with low levels of moderate physical activity (MPA). Options for increasing MPA in community dwelling adults with ADRD and their caregivers are limited. A home-based physical activity intervention delivered remotely via video conferencing to groups of adults with ADRD and their caregivers (RGV), represents a potentially effective approach for increasing MPA in this group. We will conduct an 18-month randomized trial (6 mos. Active intervention, 6 mos. Maintenance, 6 mos. no contact) to compare the effectiveness of the RGV approach with usual care, enhanced with caregiver support (EUC), for increasing MPA in 100 community dwelling adults with ADRD and their caregiver. The primary aim is to compare MPA (min/wk.), assessed by accelerometer, across the 6-mo. active intervention in adults with ADRD randomized to RGV or EUC. Secondarily, we will compare adults with ADRD and their caregivers randomized to RGV or ECU on the following outcomes across 18 mos.: MPA (min/wk.), sedentary time (min/wk.), percentage meeting 150 min/wk. MPA goal, functional fitness, activities of daily living, quality of life, residential transitions, cognitive function, and caregiver burden. Additionally, we will evaluate the influence of age, sex, BMI, attendance (exercise/support sessions), use of recorded sessions, self-monitoring, peer interactions during group sessions, caregiver support, type and quality of dyadic relationship, and number of caregivers on changes in MPA in adults with ADRD and their caregiver across 18 mos.",2020,"A home-based physical activity intervention delivered remotely via video conferencing to groups of adults with ADRD and their caregivers (RGV), represents a potentially effective approach for increasing MPA in this group.","['community dwelling adults with ADRD and their caregivers', ""Adults with Alzheimer's disease and related dementia (ADRD) and their caregivers represent a sizeable and underserved segment of the population with low levels of moderate physical activity (MPA"", 'adults with ADRD randomized to', ""adults with Alzheimer's disease and their caregivers"", '100 community dwelling adults with ADRD and their caregiver', 'adults with ADRD and their caregivers randomized to', 'adults with ADRD and their caregivers (RGV', 'adults with ADRD and their caregiver across 18 mos']","['remote physical activity intervention', 'RGV or EUC', 'RGV approach with usual care, enhanced with caregiver support (EUC', 'RGV or ECU']","['MPA goal, functional fitness, activities of daily living, quality of life, residential transitions, cognitive function, and caregiver burden']","[{'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0150162', 'cui_str': 'Caregiver support'}, {'cui': 'C0013593', 'cui_str': 'Ecuador'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}]",100.0,0.092155,"A home-based physical activity intervention delivered remotely via video conferencing to groups of adults with ADRD and their caregivers (RGV), represents a potentially effective approach for increasing MPA in this group.","[{'ForeName': 'Lauren T', 'Initials': 'LT', 'LastName': 'Ptomey', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Blvd, Kansas City, KS 66160, USA. Electronic address: lptomey@kumc.edu.'}, {'ForeName': 'Amanda N', 'Initials': 'AN', 'LastName': 'Szabo-Reed', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Blvd, Kansas City, KS 66160, USA. Electronic address: aszabo@kumc.edu.'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Vidoni', 'Affiliation': 'Department of Neurology, The University of Kansas Medical Center, 3901 Rainbow Blvd, Kansas City, KS 66160, USA. Electronic address: evidoni@kumc.edu.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Washburn', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Blvd, Kansas City, KS 66160, USA. Electronic address: rwashburn@ku.edu.'}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Gorczyca', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Blvd, Kansas City, KS 66160, USA. Electronic address: agorczyca@ku.edu.'}, {'ForeName': 'Todd D', 'Initials': 'TD', 'LastName': 'Little', 'Affiliation': 'Department of Educational Psychology and Leadership, Texas Tech University, 2500 Broadway, Lubbock, TX 79409, USA. Electronic address: todd.d.little@ttu.edu.'}, {'ForeName': 'Jaehoon', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Educational Psychology and Leadership, Texas Tech University, 2500 Broadway, Lubbock, TX 79409, USA. Electronic address: jaehoon.lee@ttu.edu.'}, {'ForeName': 'Brian C', 'Initials': 'BC', 'LastName': 'Helsel', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Blvd, Kansas City, KS 66160, USA. Electronic address: bhelsel@kumc.edu.'}, {'ForeName': 'Kristine N', 'Initials': 'KN', 'LastName': 'Williams', 'Affiliation': 'School of Nursing, The University of Kansas Medical Center, 3901 Rainbow Blvd, Kansas City, KS 66160, USA. Electronic address: kwilliams1@kumc.edu.'}, {'ForeName': 'Joseph E', 'Initials': 'JE', 'LastName': 'Donnelly', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Blvd, Kansas City, KS 66160, USA. Electronic address: jdonnelly@ku.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106158']
2962,32979521,Neural correlates of future weight loss reveal a possible role for brain-gastric interactions.,"Lifestyle dietary interventions are an essential practice in treating obesity, hence neural factors that may assist in predicting individual treatment success are of great significance. Here, in a prospective, open-label, three arms study, we examined the correlation between brain resting-state functional connectivity measured at baseline and weight loss following 6 months of lifestyle intervention in 92 overweight participants. We report a robust subnetwork composed mainly of sensory and motor cortical regions, whose edges correlated with future weight loss. This effect was found regardless of intervention group. Importantly, this main finding was further corroborated using a stringent connectivity-based prediction model assessed with cross-validation thus attesting to its robustness. The engagement of senso-motor regions in this subnetwork is consistent with the over-sensitivity to food cues theory of weight regulation. Finally, we tested an additional hypothesis regarding the role of brain-gastric interaction in this subnetwork, considering recent findings of a cortical network synchronized with gastric activity. Accordingly, we found a significant spatial overlap with the subnetwork reported in the present study. Moreover, power in the gastric basal electric frequency within our reported subnetwork negatively correlated with future weight loss. This finding was specific to the weight loss related subnetwork and to the gastric basal frequency. These findings should be further corroborated by combining direct recordings of gastric activity in future studies. Taken together, these intriguing results may have important implications for our understanding of the etiology of obesity and the mechanism of response to dietary intervention.",2020,This effect was found regardless of intervention group.,['92 overweight participants'],['Lifestyle dietary interventions'],['brain resting-state functional connectivity'],"[{'cui': 'C0497406', 'cui_str': 'Overweight'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}]","[{'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]",92.0,0.0170556,This effect was found regardless of intervention group.,"[{'ForeName': 'Gidon', 'Initials': 'G', 'LastName': 'Levakov', 'Affiliation': 'Department of Brain and Cognitive Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel; Zlotowski Center for Neuroscience, Ben-Gurion University of the Negev, Beer-Sheva, Israel. Electronic address: gidonle@post.bgu.ac.il.'}, {'ForeName': 'Alon', 'Initials': 'A', 'LastName': 'Kaplan', 'Affiliation': 'Department of Epidemiology, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Anat', 'Initials': 'A', 'LastName': 'Yaskolka Meir', 'Affiliation': 'Department of Epidemiology, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Ehud', 'Initials': 'E', 'LastName': 'Rinott', 'Affiliation': 'Department of Epidemiology, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Gal', 'Initials': 'G', 'LastName': 'Tsaban', 'Affiliation': 'Department of Epidemiology, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Hila', 'Initials': 'H', 'LastName': 'Zelicha', 'Affiliation': 'Department of Epidemiology, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Nachshon', 'Initials': 'N', 'LastName': 'Meiran', 'Affiliation': 'Zlotowski Center for Neuroscience, Ben-Gurion University of the Negev, Beer-Sheva, Israel; Department of Psychology, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Ilan', 'Initials': 'I', 'LastName': 'Shelef', 'Affiliation': 'Zlotowski Center for Neuroscience, Ben-Gurion University of the Negev, Beer-Sheva, Israel; Department of Diagnostic Imaging, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Shai', 'Affiliation': 'Department of Epidemiology, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Galia', 'Initials': 'G', 'LastName': 'Avidan', 'Affiliation': 'Department of Brain and Cognitive Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel; Zlotowski Center for Neuroscience, Ben-Gurion University of the Negev, Beer-Sheva, Israel; Department of Psychology, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}]",NeuroImage,['10.1016/j.neuroimage.2020.117403']
2963,32979635,Endothelial shear stress and vascular remodeling in bioresorbable scaffold and metallic stent.,"BACKGROUND AND AIMS


The impact of endothelial shear stress (ESS) on vessel remodeling in vessels implanted with bioresorbable scaffold (BRS) as compared to metallic drug-eluting stent (DES) remains elusive. The aim of this study was to determine whether the relationship between ESS and remodeling patterns differs in BRS from those seen in metallic DES at 3-year follow-up.
METHODS


In the ABSORB II randomized trial, lesions were investigated by serial coronary angiography and intravascular ultrasound (IVUS). Three-dimensional reconstructions of coronary arteries post-procedure and at 3 years were performed. ESS was quantified using non-Newtonian steady flow simulation. IVUS cross-sections in device segment were matched using identical landmarks.
RESULTS


Paired ESS calculations post-procedure and at 3 years were feasible in 57 lesions in 56 patients. Post-procedure, median ESS at frame level was higher in BRS than in DES, with marginal statistical significance (0.97 ± 0.48 vs. 0.75 ± 0.39 Pa, p = 0.063). In the BRS arm, vessel area and lumen area showed larger increases in the highest tercile of median ESS post-procedure as compared to the lowest tercile. In contrast, in DES, no significant relationship between median ESS post-procedure and remodeling was observed. In multivariate analysis, smaller vessel area, larger lumen area, higher plaque burden post-procedure, and higher median ESS post-procedure were independently associated with expansive remodeling in matched frames. Only in BRS, younger age was an additional significant predictor of expansive remodeling.
CONCLUSIONS


In a subset of lesions with large plaque burden, shear stress could be associated with expansive remodeling and late lumen enlargement in BRS, while ESS had no impact on vessel dimension in metallic DES.",2020,"In multivariate analysis, smaller vessel area, larger lumen area, higher plaque burden post-procedure, and higher median ESS post-procedure were independently associated with expansive remodeling in matched frames.",[],"['bioresorbable scaffold (BRS', 'endothelial shear stress (ESS']",['Endothelial shear stress and vascular remodeling'],[],"[{'cui': 'C0337143', 'cui_str': 'Scaffold'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0175735', 'cui_str': 'Scissors'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]","[{'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0175735', 'cui_str': 'Scissors'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C3850148', 'cui_str': 'Vascular Remodeling'}]",,0.0802054,"In multivariate analysis, smaller vessel area, larger lumen area, higher plaque burden post-procedure, and higher median ESS post-procedure were independently associated with expansive remodeling in matched frames.","[{'ForeName': 'Erhan', 'Initials': 'E', 'LastName': 'Tenekecioglu', 'Affiliation': 'Department of Interventional Cardiology, Erasmus University Medical Center. Thoraxcenter, Rotterdam, the Netherlands.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Katagiri', 'Affiliation': 'Department of Cardiology Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Kuniaki', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'Department of Cardiology Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Mariusz', 'Initials': 'M', 'LastName': 'Tomaniak', 'Affiliation': 'Department of Interventional Cardiology, Erasmus University Medical Center. Thoraxcenter, Rotterdam, the Netherlands; First Department of Cardiology, Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Dariusz', 'Initials': 'D', 'LastName': 'Dudek', 'Affiliation': 'Department of Interventional Cardiology, Jagiellonian University, Krakow, Poland.'}, {'ForeName': 'Angel', 'Initials': 'A', 'LastName': 'Cequier', 'Affiliation': 'Bellvitge University Ho^spital, Barcelona, Spain.'}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Carrié', 'Affiliation': 'Hopital de Rangueil, Toulouse, France.'}, {'ForeName': 'Andrés', 'Initials': 'A', 'LastName': 'Iñiguez', 'Affiliation': 'Interventional Cardiology Unit, Cardiology Department, Hospital Alvaro Cunqueiro, University Hospital of Vigo, Vigo, Spain.'}, {'ForeName': 'Rinse', 'Initials': 'R', 'LastName': 'Johannes van der Schaaf', 'Affiliation': 'Onze Lieve Vrouwe Gasthuis, Amsterdam, the Netherlands.'}, {'ForeName': 'Marcello', 'Initials': 'M', 'LastName': 'Dominici', 'Affiliation': 'S Maria University Hospital, Terni, Italy.'}, {'ForeName': 'Ad J van', 'Initials': 'AJV', 'LastName': 'Boven', 'Affiliation': 'Medical Center Leeuwarden, Leeuwarden, the Netherlands.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Helqvist', 'Affiliation': 'Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Manel', 'Initials': 'M', 'LastName': 'Sabaté', 'Affiliation': 'Biomédiques August Pi I Sunyer, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Baumbach', 'Affiliation': 'Bristol Heart Institute, Bristol, United Kingdom.'}, {'ForeName': 'Jan J', 'Initials': 'JJ', 'LastName': 'Piek', 'Affiliation': 'Department of Cardiology Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Joanna J', 'Initials': 'JJ', 'LastName': 'Wykrzykowska', 'Affiliation': 'Department of Cardiology Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'Kitslaar', 'Affiliation': 'LKEB-Division of Image Processing, Department of Radiology, Leiden University Medical Centre, Leiden, the Netherlands.'}, {'ForeName': 'Jouke', 'Initials': 'J', 'LastName': 'Dijkstra', 'Affiliation': 'LKEB-Division of Image Processing, Department of Radiology, Leiden University Medical Centre, Leiden, the Netherlands.'}, {'ForeName': 'Johan H C', 'Initials': 'JHC', 'LastName': 'Reiber', 'Affiliation': 'LKEB-Division of Image Processing, Department of Radiology, Leiden University Medical Centre, Leiden, the Netherlands.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Chevalier', 'Affiliation': 'Ramsay Générale de Santé, Institut Cardiovasculaire Paris Sud, Massy, France.'}, {'ForeName': 'Dilek', 'Initials': 'D', 'LastName': 'Ural', 'Affiliation': 'Department of Cardiology, Koç University, Istanbul, Turkey.'}, {'ForeName': 'Kerem', 'Initials': 'K', 'LastName': 'Pekkan', 'Affiliation': 'Department of Mechanical Engineering, Koç University, Istanbul, Turkey.'}, {'ForeName': 'Christos V', 'Initials': 'CV', 'LastName': 'Bourantas', 'Affiliation': 'Department of Cardiology, University College of London Hospitals, London, United Kingdom; Department of Cardiology, Barts Heart Centre, London, United Kingdom.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Gijsen', 'Affiliation': 'Department of Biomedical Engineering, Erasmus University Medical Center, Thoraxcenter, Rotterdam, the Netherlands.'}, {'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Onuma', 'Affiliation': 'Department of Interventional Cardiology, Erasmus University Medical Center. Thoraxcenter, Rotterdam, the Netherlands.'}, {'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Torii', 'Affiliation': 'Department of Mechanical Engineering, University College London, United Kingdom.'}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': 'Imperial College London, London, United Kingdom; Department of cardiology, National University of Ireland, Galway (NUIG), Galway, Ireland. Electronic address: patrick.w.j.c.serruys@gmail.com.'}]",Atherosclerosis,['10.1016/j.atherosclerosis.2020.08.031']
2964,32980608,Interprofessional simulation-based training in gynecologic oncology palliative care for students in the healthcare profession: A comparative randomized controlled trial.,"BACKGROUND


Preprofessional palliative care education may be inadequate, leaving a gap in health professional students' knowledge and understanding of managing patients with gynecologic cancer and their families. Interprofessional simulation-based training may be useful in helping health professional students gain the necessary skills required for palliative care.
OBJECTIVE


This study aimed to determine the effectiveness of different simulation methods used for interprofessional training on gynecologic oncology palliative care knowledge, interdisciplinary education perceptions, and teamwork attitudes of health professional students and to compare these methods.
DESIGN


A comparative randomized controlled trial was conducted with a pre-test and two post-tests.
SETTINGS


This study was conducted at a university in Ankara, Turkey, in 2016-2017.
PARTICIPANTS


A convenience sample of 84 interprofessional students (nursing, medical, nutrition-dietician, and social work) was used in the study.
METHODS


Students were stratified by their profession and randomized by four blocks into high-fidelity simulation, hybrid simulation, and a control group. Data were collected using a semi-structured questionnaire form, palliative care knowledge test, interdisciplinary education perception scale, and teamwork attitudes questionnaire.
RESULTS


The high-fidelity simulation and hybrid simulation groups improved their palliative care knowledge, interdisciplinary education perception, and teamwork attitudes from pre-test to first and second post-tests compared to the control group.
CONCLUSION


The introduction of high-fidelity simulation and hybrid simulation or hybrid simulation-based interprofessional training in undergraduate education can increase students' palliative care knowledge, interdisciplinary education perception, and teamwork attitudes. Training programs that are used together with high-fidelity simulation and hybrid simulation applications in interdisciplinary training should be integrated into the undergraduate curricula of future cooperating health professions.",2020,"The high-fidelity simulation and hybrid simulation groups improved their palliative care knowledge, interdisciplinary education perception, and teamwork attitudes from pre-test to first and second post-tests compared to the control group.
","['health professional students', 'A convenience sample of 84 interprofessional students (nursing, medical, nutrition-dietician, and social work) was used in the study', 'patients with gynecologic cancer and their families', 'Students were stratified by their profession', 'students in the healthcare profession', 'university in Ankara, Turkey, in 2016-2017']","['interprofessional training', 'Interprofessional simulation-based training', 'hybrid simulation-based interprofessional training']","['palliative care knowledge, interdisciplinary education perception, and teamwork attitudes']","[{'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C3536818', 'cui_str': 'Dietitian'}, {'cui': 'C0037441', 'cui_str': 'Social Service'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0699889', 'cui_str': 'Female reproductive neoplasm malignant NOS'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0028811', 'cui_str': 'Occupation'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0041400', 'cui_str': 'Turkey - country'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}]","[{'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]",84.0,0.0506668,"The high-fidelity simulation and hybrid simulation groups improved their palliative care knowledge, interdisciplinary education perception, and teamwork attitudes from pre-test to first and second post-tests compared to the control group.
","[{'ForeName': 'Fatma', 'Initials': 'F', 'LastName': 'Uslu-Sahan', 'Affiliation': 'Department of Obstetrics and Gynecologic Nursing, Faculty of Nursing, Hacettepe University, Ankara, Turkey. Electronic address: fatma.uslu@hacettepe.edu.tr.'}, {'ForeName': 'Fusun', 'Initials': 'F', 'LastName': 'Terzioglu', 'Affiliation': 'Faculty of Health Science, Atilim University, Ankara, Turkey.'}]",Nurse education today,['10.1016/j.nedt.2020.104588']
2965,32980623,Successful implementation of text-based blood pressure monitoring for postpartum hypertension.,"OBJECTIVES


A clinical trial showed postpartum text-based blood pressure (BP) monitoring is effective in meeting clinical guidelines and reduces racial disparities in postpartum hypertension care. Our objective was to compare clinical outcomes to those from a clinical trial after implementation of the program in a second hospital within our hospital system.
STUDY DESIGN


Comparison of women randomized to text-based BP monitoring in a clinical trial compared to an implementation cohort clinically enrolled in text-based BP monitoring. BP outcomes and postpartum visit were compared in bivariate and multivariable analyses.
MAIN OUTCOME MEASURES


BP ascertainment was defined as at least 1 BP texted during the 10 days of monitoring. American College of Obstetricians and Gynecologists (ACOG) recommendation was defined as BP sent on postpartum day 3-4 and again day 7-10.
RESULTS


The implementation cohort had 333 women compared to 103 in the trial cohort. The implementation cohort was older (p < 0.001), and more likely to be non-Black race (p < 0.001), married (<0.001), and have commercial insurance (<0.001). BP ascertainment (95.5% vs. 92.2%, adjusted OR 1.41, [95% CI 0.55, 3.58]) and proportion meeting ACOG recommendations (84.7% vs. 81.6%, adjusted OR 0.89 [95% CI 0.48, 1.64]) were similar between groups. There were no differences in BP ascertainment among Black and non-Black women in the trial or implementation cohort.
CONCLUSIONS


Text-based BP monitoring performed similarly in an implementation cohort compared to the trial participants. This program is scalable to manage postpartum hypertension and reduce racial disparities in postpartum care in women with hypertensive disorders of pregnancy.",2020,"The implementation cohort was older (p < 0.001), and more likely to be non-Black race (p < 0.001), married (<0.001), and have commercial insurance (<0.001).","['postpartum hypertension', 'women with hypertensive disorders of pregnancy', '333 women compared to 103 in the trial cohort', 'American College of Obstetricians and Gynecologists (ACOG']","['text-based BP monitoring', 'text-based blood pressure monitoring', 'postpartum text-based blood pressure (BP) monitoring']","['BP ascertainment', 'proportion meeting ACOG recommendations', 'BP outcomes and postpartum visit']","[{'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0852260', 'cui_str': 'Hypertension associated disorders of pregnancy'}, {'cui': 'C4517724', 'cui_str': '333'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0586884', 'cui_str': 'Obstetrician and gynecologist'}, {'cui': 'C0237419', 'cui_str': 'Gynecologist'}]","[{'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0026426', 'cui_str': 'Blood pressure monitoring'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0556656', 'cui_str': 'Meetings'}, {'cui': 'C0237419', 'cui_str': 'Gynecologist'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}]",,0.173943,"The implementation cohort was older (p < 0.001), and more likely to be non-Black race (p < 0.001), married (<0.001), and have commercial insurance (<0.001).","[{'ForeName': 'Jourdan E', 'Initials': 'JE', 'LastName': 'Triebwasser', 'Affiliation': 'Department of Obstetrics and Gynecology, Maternal and Child Health Research Center University of Pennsylvania Perelman School of Medicine, 421 Curie Boulevard, 1353 Biomedical Research Bldg. II/III, Philadelphia, PA 19104, USA; Department of Obstetrics and Gynecology, Pennsylvania Hospital University of Pennsylvania Perelman School of Medicine, 800 Spruce St. 2 Pine East, Philadelphia, PA 19107, USA. Electronic address: jourdan.triebwasser@pennmedicine.upenn.edu.'}, {'ForeName': 'Matthew K', 'Initials': 'MK', 'LastName': 'Janssen', 'Affiliation': 'Department of Obstetrics and Gynecology, Pennsylvania Hospital University of Pennsylvania Perelman School of Medicine, 800 Spruce St. 2 Pine East, Philadelphia, PA 19107, USA. Electronic address: matthew.janssen@pennmedicine.upenn.edu.'}, {'ForeName': 'Adi', 'Initials': 'A', 'LastName': 'Hirshberg', 'Affiliation': 'Department of Obstetrics and Gynecology, Maternal and Child Health Research Center University of Pennsylvania Perelman School of Medicine, 421 Curie Boulevard, 1353 Biomedical Research Bldg. II/III, Philadelphia, PA 19104, USA. Electronic address: adi.hirshberg@pennmedicine.upenn.edu.'}, {'ForeName': 'Sindhu K', 'Initials': 'SK', 'LastName': 'Srinivas', 'Affiliation': 'Department of Obstetrics and Gynecology, Maternal and Child Health Research Center University of Pennsylvania Perelman School of Medicine, 421 Curie Boulevard, 1353 Biomedical Research Bldg. II/III, Philadelphia, PA 19104, USA. Electronic address: ssrinivas@pennmedicine.upenn.edu.'}]",Pregnancy hypertension,['10.1016/j.preghy.2020.09.001']
2966,32980656,Effectiveness of the Super Skills for Life programme in enhancing the emotional wellbeing of children and adolescents in residential care institutions in a low- and middle-income country: A randomised waitlist-controlled trial.,"BACKGROUND


The present study examined the effectiveness of a transdiagnostic prevention programme, Super Skills for Life (SSL), among children and adolescents with emotional problems in residential care institutions (RCIs) in the low- and middle-income country of Mauritius using a randomised waitlist-controlled trial (RCT). SSL is based on the principles of cognitive behavioural therapy, behavioural activation, social skills training, and uses video-feedback and cognitive preparation as part of the treatment.
METHODS


The RCT involved 100 children and adolescents aged 9 to 14 years, from six RCIs, randomly allocated to either an SSL intervention group (IG) or a waitlist-control (WLC) group. A set of questionnaires measuring internalising and externalising problems, emotion regulation and self-esteem, and experimental tasks measuring attentional bias and inhibitory control, were completed at baseline, post-intervention and 3-month follow-up. Participants also completed a 2-min video speech task during the first and final sessions of the SSL intervention.
RESULTS


Children and adolescents in the IG showed significant improvements in internalising symptoms (e.g. anxiety and depression), externalising symptoms (e.g. conduct problems and hyperactivity), and inhibitory control, and an increase in adaptive (except putting into perspective strategy) and decrease in maladaptive emotion regulation strategies, at both post-intervention and follow-up. These findings were not replicated among children in the WLC.
LIMITATIONS


The small sample size and lack of an active control group were the major limitations of this study.
CONCLUSIONS


This study provides evidence for the effectiveness of a transdiagnostic prevention programme for emotional problems in RCIs in a low- and middle-income country.",2020,"RESULTS


Children and adolescents in the IG showed significant improvements in internalising symptoms (e.g. anxiety and depression), externalising symptoms (e.g. conduct problems and hyperactivity), and inhibitory control, and an increase in adaptive (except putting into perspective strategy) and decrease in maladaptive emotion regulation strategies, at both post-intervention and follow-up.","['children and adolescents with emotional problems in residential care institutions (RCIs) in the low- and middle-income country of Mauritius', 'children and adolescents in residential care institutions in a low- and middle-income country', 'emotional problems in RCIs in a low- and middle-income country', '100 children and adolescents aged 9 to 14 years, from six RCIs']","['transdiagnostic prevention programme', 'SSL intervention group (IG) or a waitlist-control (WLC', 'Super Skills for Life programme', 'transdiagnostic prevention programme, Super Skills for Life (SSL', 'SSL']","['emotional wellbeing', 'maladaptive emotion regulation strategies', 'internalising symptoms (e.g. anxiety and depression), externalising symptoms (e.g. conduct problems and hyperactivity), and inhibitory control', 'questionnaires measuring internalising and externalising problems, emotion regulation and self-esteem, and experimental tasks measuring attentional bias and inhibitory control']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0677660', 'cui_str': 'Emotional problems'}, {'cui': 'C0035186', 'cui_str': 'Residential Facilities'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0024944', 'cui_str': 'Mauritius'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0424295', 'cui_str': 'Hyperactive behavior'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C4277667', 'cui_str': 'Attentional Biases'}]",100.0,0.0681738,"RESULTS


Children and adolescents in the IG showed significant improvements in internalising symptoms (e.g. anxiety and depression), externalising symptoms (e.g. conduct problems and hyperactivity), and inhibitory control, and an increase in adaptive (except putting into perspective strategy) and decrease in maladaptive emotion regulation strategies, at both post-intervention and follow-up.","[{'ForeName': 'Karishma', 'Initials': 'K', 'LastName': 'Ramdhonee-Dowlot', 'Affiliation': 'Department of Psychology, University of Roehampton, UK. Electronic address: ramdhonk@roehampton.ac.uk.'}, {'ForeName': 'Kieran', 'Initials': 'K', 'LastName': 'Balloo', 'Affiliation': 'University of Surrey, UK.'}, {'ForeName': 'Cecilia A', 'Initials': 'CA', 'LastName': 'Essau', 'Affiliation': 'Department of Psychology, University of Roehampton, UK.'}]",Journal of affective disorders,['10.1016/j.jad.2020.09.053']
2967,32980696,The exploration of optimized protocol for repetitive transcranial magnetic stimulation in the treatment of methamphetamine use disorder: A randomized sham-controlled study.,"BACKGROUND


The prefrontal-striatal circuit is a core circuit related to substance dependence. Previous studies have found that repetitive transcranial magnetic stimulation (rTMS) targeting the dorsolateral prefrontal cortex (DLPFC) (key region of executive network) had limited responses, while inhibiting hyperactivation of ventromedial prefrontal cortex (vmPFC) (key region of limbic network) may be another strategy. However, there is currently no comparison between these two treatment locations.
METHODS


Seventy-four methamphetamine-dependent patients were randomly assigned to one of treatment groups with two-week treatment: (1) Group A: intermittent theta-burst stimulation (iTBS) targeting the left DLPFC; (2) Group B: continuous theta-burst stimulation (cTBS) targeting the left vmPFC; (3) Group C: a combination of treatment protocol of Group A and Group B; (4) Group D: sham theta-burst stimulation. The primary endpoint was the change of cue-induced craving. The trial was registered at ClinicalTrials.gov (NCT03736317).
FINDINGS


The three real TBS groups had more craving decrease effect than the sham group (p<0.01). The changes of craving were positively correlated with the improvement of anxiety and withdrawal symptom. With the highest respondence rate, group C also had shorter respondence time than Group A (p = 0.03). Group C was effective in improve depression symptoms (p = 0.04) and withdrawal symptom (p = 0.02) compared with Group D. Besides, Group C was significant in improve sleep quality (p = 0.04) compared with Group A. Baseline depression scores and spatial working memory were positively predicting the intervention response.
INTERPRETATION


The rTMS paradigms involving vmPFC with cTBS are optimized protocols and well-tolerated for methamphetamine-dependent individuals, and they may have better efficacies compared with DLPFC iTBS. Emotion and cognitive function are rTMS treatment response predictors for methamphetamine-dependent patients.
FUNDING


This work was supported by the National Key R&D Program of China (2017YFC1310400), National Natural Science Foundation of China (81,771,436, 81,801,319, 81,601,164), Shanghai Municipal Health and Family Planning Commission (2017ZZ02021), Municipal Human Resources Development Program for Outstanding Young Talents in Medical and Health Sciences in Shanghai (2017YQ013), Qihang Project of Shanghai Mental Health Center (2019-QH-05), Shanghai Sailing Program (19YF1442100), Shanghai Key Laboratory of Psychotic Disorders (13DZ2260500), Program of Shanghai Academic Research Leader (17XD1403300), Shanghai Municipal Science and Technology Major Project (2018SHZDZX05), and Shanghai Clinical Research Center for Mental Health (19MC1911100).",2020,Group C was effective in improve depression symptoms (p = 0.04) and withdrawal symptom (p = 0.02) compared with Group D.,"['methamphetamine use disorder', 'methamphetamine-dependent patients', 'Seventy-four methamphetamine-dependent patients']","['repetitive transcranial magnetic stimulation (rTMS', 'repetitive transcranial magnetic stimulation', 'intermittent theta-burst stimulation (iTBS) targeting the left DLPFC; (2) Group B: continuous theta-burst stimulation (cTBS) targeting the left vmPFC; (3) Group C: a combination of treatment protocol of Group A and Group B; (4) Group D: sham theta-burst stimulation']","['Baseline depression scores and spatial working memory', 'change of cue-induced craving', 'withdrawal symptom', 'depression symptoms', 'Emotion and cognitive function', 'anxiety and withdrawal symptom', 'sleep quality', 'changes of craving', 'shorter respondence time']","[{'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0581116', 'cui_str': 'Dependent patient'}, {'cui': 'C4517867', 'cui_str': '74'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C3850122', 'cui_str': 'Ventral Medial Prefrontal Cortex'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0441838', 'cui_str': 'Group D'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0087169', 'cui_str': 'Withdrawal symptom'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",74.0,0.049341,Group C was effective in improve depression symptoms (p = 0.04) and withdrawal symptom (p = 0.02) compared with Group D.,"[{'ForeName': 'Tianzhen', 'Initials': 'T', 'LastName': 'Chen', 'Affiliation': '(a)Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Su', 'Affiliation': '(a)Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Ruihua', 'Initials': 'R', 'LastName': 'Li', 'Affiliation': '(a)Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Haifeng', 'Initials': 'H', 'LastName': 'Jiang', 'Affiliation': '(a)Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Xiaotong', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': '(a)Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Qianying', 'Initials': 'Q', 'LastName': 'Wu', 'Affiliation': '(a)Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Haoye', 'Initials': 'H', 'LastName': 'Tan', 'Affiliation': '(a)Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Jingying', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': '(a)Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Zhong', 'Affiliation': '(a)Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'Du', 'Affiliation': '(a)Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Huijuan', 'Initials': 'H', 'LastName': 'Gu', 'Affiliation': '(b)Shanghai Drug Rehabilitation Center of Public Security Bureau, Shanghai, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Zhao', 'Affiliation': '(a)Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China; (c)Shanghai Key Laboratory of Psychotic Disorders, Shanghai, China; (d)Institute of Psychological and Behavioral Science, Shanghai Jiao Tong University, Shanghai, China; (e)CAS Center for Excellence in Brain Science and Intelligence Technology (CEBSIT), Chinese Academy of Sciences, Shanghai, China. Electronic address: drminzhao@smhc.org.cn.'}]",EBioMedicine,['10.1016/j.ebiom.2020.103027']
2968,32978722,A Phase I Placebo-Controlled Trial Comparing the Effects of Buprenorphine Buccal Film and Oral Oxycodone Hydrochloride Administration on Respiratory Drive.,"INTRODUCTION


Buprenorphine is a partial μ-opioid receptor agonist that, unlike full μ-opioid receptor agonists, has been shown to have a ceiling effect on respiratory depression. Buprenorphine buccal film (BBF) is approved by the US Food and Drug Administration for use in patients with chronic pain severe enough to require daily, around-the-clock, long-term opioid treatment and for whom alternative treatment options are inadequate. This study was conducted to compare the effects of BBF and immediate-release oral oxycodone hydrochloride administration on respiratory drive, as measured by the ventilatory response to hypercapnia (VRH) after drug administration.
METHODS


Subjects (N = 19) were men and women, ages 27-41 years, self-identifying as recreational opioid users who were not physically dependent on opioids as determined via a Naloxone Challenge Test. Respiratory drive was evaluated by measuring VRH through the assessment of the maximum decrease in minute ventilation (E max ) after administration of each treatment. The treatments utilized in this study included 300, 600, and 900 μg BBF; 30 and 60 mg orally administered oxycodone; and placebo (each separated by a 7-day washout period). Effects on respiratory drive were assessed using a double-blind, double-dummy, six-treatment, six-period, placebo-controlled, randomized crossover design. Statistical analyses were performed using a linear mixed-effects model.
RESULTS


The least squares mean differences in minute volume E max  (L/min, versus placebo) were as follows: 300 μg BBF (+ 1.24, P = 0.529), 600 μg BBF (+ 0.23, P = 0.908), 900 μg BBF (+ 0.93, P = 0.637), 30 mg oxycodone (- 0.79, P = 0.687), and 60 mg oxycodone (- 5.23, P = 0.010).
CONCLUSIONS


BBF did not significantly reduce respiratory drive at any dose compared with placebo, including at the maximum available prescription dose of 900 μg. Administration of oxycodone resulted in a significant dose-dependent decrease in respiratory drive. These data suggest that BBF may be a safer treatment option than full μ-opioid receptor agonists for patients with chronic pain.
TRIAL REGISTRATION


ClinicalTrials.gov identifier, NCT03996694.",2020,"CONCLUSIONS


BBF did not significantly reduce respiratory drive at any dose compared with placebo, including at the maximum available prescription dose of 900 μg.","['300, 600, and 900\xa0μg BBF; 30 and 60\xa0mg orally administered', 'patients with chronic pain severe', 'Subjects (N\u2009=\u200919) were men and women, ages 27-41\xa0years, self-identifying as recreational opioid users who were not physically dependent on opioids as determined via a Naloxone Challenge Test', 'patients with chronic pain']","['Buprenorphine buccal film (BBF', 'oxycodone; and placebo', 'Buprenorphine Buccal Film and Oral Oxycodone Hydrochloride', 'Buprenorphine', 'BBF', 'oxycodone hydrochloride', 'placebo', 'oxycodone', 'Placebo']","['minute ventilation (E max ', 'ventilatory response to hypercapnia (VRH', 'respiratory drive']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C4517900', 'cui_str': '900'}, {'cui': 'C4056633', 'cui_str': 'Buprenorphine Buccal Film [Belbuca]'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0027358', 'cui_str': 'Naloxone'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C4056633', 'cui_str': 'Buprenorphine Buccal Film [Belbuca]'}, {'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0282274', 'cui_str': 'Oxycodone hydrochloride'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}]","[{'cui': 'C1301655', 'cui_str': 'Minute ventilation'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0020440', 'cui_str': 'Hypercapnia'}, {'cui': 'C0004379', 'cui_str': 'Driving'}]",,0.319049,"CONCLUSIONS


BBF did not significantly reduce respiratory drive at any dose compared with placebo, including at the maximum available prescription dose of 900 μg.","[{'ForeName': 'Lynn R', 'Initials': 'LR', 'LastName': 'Webster', 'Affiliation': 'PRA Health Sciences, Salt Lake City, UT, USA. WebsterLynn@prahs.com.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Hansen', 'Affiliation': 'PRA Health Sciences, Salt Lake City, UT, USA.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Cater', 'Affiliation': 'PRA Health Sciences, Salt Lake City, UT, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Smith', 'Affiliation': 'BioDelivery Sciences International, Inc., Raleigh, NC, USA.'}]",Advances in therapy,['10.1007/s12325-020-01481-0']
2969,32979724,Sufficient vitamin D status positively modified ventilatory function in asthmatic children following a Mediterranean diet enriched with fatty fish intervention study.,"Asthma in children is the most prevalent allergic disease worldwide that has become a major public health priority. The objective of this study was to examine the relationship between baseline serum vitamin D status, spirometry, and fractional exhaled nitric oxide levels (FeNO) in 64 Greek children with 'mild asthma' aged 5 to 12 years (51.6% male) in a dietary intervention study. We hypothesized that baseline serum vitamin D levels modify the beneficial response of fatty fish intake on pulmonary function in asthmatic children following a Mediterranean diet. The intervention group consumed 2 fatty fish meals/week (≥150 g cooked filleted fish/meal) as part of the Mediterranean diet for six months, and the control group consumed their usual diet. Baseline serum 25(OH)D was determined using enzyme-linked immunoassay and defined as sufficient levels of 25(OH)D ≥25 ng/mL. Only 36% of children were graded as sufficient in 25(OH)D levels on entry into the study with a higher proportion of girls insufficient than boys (61% vs 39% respectively). Participants with sufficient levels of serum 25(OH)D at baseline, consuming the intervention diet increased FEV 1 /FVC by 4.89 units (β = 4.89; 95%CI: 1.19-8.61; p = 0.013) and FEF 25-75%  by 12.83 units (β = 12.83; 95%CI: 4.27-21.40; p = 0.006) compared to controls. No significant differences in pulmonary function or FeNO were observed for those with insufficient levels of 25(OH) D in the intervention or control groups. In conclusion, sufficient serum vitamin D levels enhanced ventilatory function in response to a dietary intervention in asthmatic children.",2020,No significant differences in pulmonary function or FeNO were observed for those with insufficient levels of 25(OH),"['asthmatic children', 'asthmatic children following a Mediterranean diet', ""64 Greek children with 'mild asthma' aged 5 to 12 years (51.6% male) in a dietary intervention study"", 'asthmatic children following a Mediterranean diet enriched with fatty fish intervention study']","['intervention group consumed 2 fatty fish meals/week (≥150 g cooked filleted fish/meal) as part of the Mediterranean diet for six months, and the control group consumed their usual diet']","['FEV 1 /FVC', 'baseline serum vitamin D status, spirometry, and fractional exhaled nitric oxide levels (FeNO', '25(OH', 'pulmonary function or FeNO', 'serum 25(OH)D', 'Baseline serum 25(OH)D']","[{'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0337806', 'cui_str': 'Greeks'}, {'cui': 'C0581124', 'cui_str': 'Mild asthma'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0453017', 'cui_str': 'Fatty fish'}, {'cui': 'C1096775', 'cui_str': 'Intervention Study'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0453017', 'cui_str': 'Fatty fish'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C0016163', 'cui_str': 'Fish'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0428586', 'cui_str': 'Serum vitamin D measurement'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]",64.0,0.0417944,No significant differences in pulmonary function or FeNO were observed for those with insufficient levels of 25(OH),"[{'ForeName': 'Maria M', 'Initials': 'MM', 'LastName': 'Papamichael', 'Affiliation': 'La Trobe University, School of Allied Health, Human Services &Sport, Department of Dietetics, Nutrition & Sport, Melbourne, Australia. Electronic address: M.Papamichael@latrobe.edu.au.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Itsiopoulos', 'Affiliation': 'La Trobe University, School of Allied Health, Human Services &Sport, Department of Dietetics, Nutrition & Sport, Melbourne, Australia; Murdoch University, College of Science, Health, Engineering & Education, Perth, Australia. Electronic address: catherine.itsiopoulos@murdoch.edu.au.'}, {'ForeName': 'Katrina', 'Initials': 'K', 'LastName': 'Lambert', 'Affiliation': 'La Trobe University, School of Psychology & Public Health, Department of Public Health, Melbourne, Australia. Electronic address: k.lambert@latrobe.edu.au.'}, {'ForeName': 'Charis', 'Initials': 'C', 'LastName': 'Katsardis', 'Affiliation': 'National & Kapodistrian University of Athens, Athens, Greece. Electronic address: xkatsardis@med.uoa.gr.'}, {'ForeName': 'Dimitris', 'Initials': 'D', 'LastName': 'Tsoukalas', 'Affiliation': 'European Institute of Nutritional Medicine, Rome, Italy. Electronic address: dtsoukalas@einum.org.'}, {'ForeName': 'Bircan', 'Initials': 'B', 'LastName': 'Erbas', 'Affiliation': 'La Trobe University, School of Psychology & Public Health, Department of Public Health, Melbourne, Australia. Electronic address: b.erbas@latrobe.edu.au.'}]","Nutrition research (New York, N.Y.)",['10.1016/j.nutres.2020.08.004']
2970,32985288,Chamomile Gel versus Urea Cream to Prevent Acute Radiation Dermatitis in Head and Neck Cancer Patients: Results from a Preliminary Clinical Trial.,"We assessed safety and potential efficacy of a chamomile gel compared with urea cream to prevent acute radiation dermatitis in head and neck cancer patients. We assessed safety and potential efficacy of the chamomile gel in escalating concentrations of 2.50%, 5.00% and 8.35% of chamomile. Concentration of 8.35% was chosen for a randomized trial comparing chamomile gel (8.35%) with urea cream (n = 24 per group), for potential efficacy to delay or prevent radiation dermatitis in these patients. Preliminary results demonstrate a delayed onset of dermatitis, with onset of Grade 2 dermatitis at 5.1 (1.3) weeks in the chamomile group and 4.5 (1.3) weeks in the urea group (effect size of 0.46). Itching, burning and hyperpigmentation were more frequently reported in the urea group. Results indicates a potential efficacy of the chamomile gel. Further studies are needed to confirm the effect of the chamomile gel in reducing or delaying the occurrence of radiation dermatitis.",2020,"Itching, burning and hyperpigmentation were more frequently reported in the urea group.","['head and neck cancer patients', 'Head and Neck Cancer Patients']","['chamomile gel', 'Chamomile Gel versus Urea Cream', 'urea cream']","['Itching, burning and hyperpigmentation', 'safety and potential efficacy', 'acute radiation dermatitis', 'Acute Radiation Dermatitis', 'delayed onset of dermatitis, with onset of Grade 2 dermatitis']","[{'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0439963', 'cui_str': 'Chamomile extract'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0041942', 'cui_str': 'Urea'}, {'cui': 'C0700385', 'cui_str': 'Cream'}]","[{'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0162834', 'cui_str': 'Hyperpigmentation'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0263606', 'cui_str': 'Early radiation dermatitis'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0011603', 'cui_str': 'Dermatitis'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}]",,0.0488546,"Itching, burning and hyperpigmentation were more frequently reported in the urea group.","[{'ForeName': 'Elaine B', 'Initials': 'EB', 'LastName': 'Ferreira', 'Affiliation': 'University of Brasília, Brasília, DF, Brazil.'}, {'ForeName': 'Marcia A', 'Initials': 'MA', 'LastName': 'Ciol', 'Affiliation': 'University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Amanda G', 'Initials': 'AG', 'LastName': 'de Meneses', 'Affiliation': 'University of Brasília, Brasília, DF, Brazil.'}, {'ForeName': 'Priscila de S M', 'Initials': 'PSM', 'LastName': 'Bontempo', 'Affiliation': 'University of Brasília, Brasília, DF, Brazil.'}, {'ForeName': 'Jeanne M', 'Initials': 'JM', 'LastName': 'Hoffman', 'Affiliation': 'University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Paula E D Dos', 'Initials': 'PEDD', 'LastName': 'Reis', 'Affiliation': 'University of Brasília, Brasília, DF, Brazil.'}]",Integrative cancer therapies,['10.1177/1534735420962174']
2971,32980245,The Impact of a Family-Based Economic Intervention on the Mental Health of HIV-Infected Adolescents in Uganda: Results From Suubi + Adherence.,"PURPOSE


This study examines the extent to which three mental health measures (hopelessness, depression, and poor self-concept) are improved through a family-based economic intervention implemented among adolescents living with HIV in Uganda.
METHODS


We used repeated measures from Suubi + Adherence, a large-scale 6-year (2012-2018) longitudinal randomized controlled trial. Bivariate analyses were conducted to test for observable group differences between the intervention and control conditions. Multilevel piecewise repeated measure mixed models were then conducted to assess hypothesized time × intervention interaction in changes in hopelessness, depression, and self-concept using participant-specific follow-up intervals.
RESULTS


At 24-month postintervention initiation, adolescents in the intervention condition reported a statistically significant lower hopelessness score than adolescents in the control condition (4.79 vs. 5.56; p = .018; N = 358). At 36-month follow-up, the intervention condition reported a statistically significant lower score on depression in the depression subgroup (N = 344) than the control condition (4.94 vs. 5.81; p = .029).
CONCLUSIONS


The results indicate that family-based economic interventions such as Suubi + Adherence can effectively improve the mental health of adolescents living with HIV who evidenced mental health challenges at baseline. Given the promising positive effects of these interventions, at least in the short term, future studies should investigate strategies to promote the sustainability of these mental health benefits.",2020,"At 36-month follow-up, the intervention condition reported a statistically significant lower score on depression in the depression subgroup (N = 344) than the control condition (4.94 vs. 5.81; p = .029).
","['Mental Health of HIV-Infected Adolescents in Uganda', 'adolescents living with HIV in Uganda']",['Family-Based Economic Intervention'],"['hopelessness, depression, and self-concept', 'hopelessness score', 'depression', 'mental health']","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0150041', 'cui_str': 'Feeling hopeless'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0036594', 'cui_str': 'Self Concept'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]",,0.0398527,"At 36-month follow-up, the intervention condition reported a statistically significant lower score on depression in the depression subgroup (N = 344) than the control condition (4.94 vs. 5.81; p = .029).
","[{'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Cavazos-Rehg', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St. Louis, Missouri. Electronic address: pcavazos@wustl.edu.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Byansi', 'Affiliation': 'Brown School, Washington University in St. Louis, St. Louis, Missouri.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Xu', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St. Louis, Missouri; Brown School, Washington University in St. Louis, St. Louis, Missouri.'}, {'ForeName': 'Proscovia', 'Initials': 'P', 'LastName': 'Nabunya', 'Affiliation': 'Brown School, Washington University in St. Louis, St. Louis, Missouri.'}, {'ForeName': 'Ozge', 'Initials': 'O', 'LastName': 'Sensoy Bahar', 'Affiliation': 'Brown School, Washington University in St. Louis, St. Louis, Missouri.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Borodovsky', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Kasson', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Nnenna', 'Initials': 'N', 'LastName': 'Anako', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St. Louis, Missouri; Brown School, Washington University in St. Louis, St. Louis, Missouri.'}, {'ForeName': 'Claude', 'Initials': 'C', 'LastName': 'Mellins', 'Affiliation': 'Departments of Psychiatry and Sociomedical Sciences, Columbia University, New York, New York.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Damulira', 'Affiliation': 'International Center for Child Health and Development, Masaka Field Office, Masaka, Uganda.'}, {'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Neilands', 'Affiliation': 'Center for AIDS Prevention Studies, University of California, San Francisco, School of Medicine, San Francisco, California.'}, {'ForeName': 'Fred M', 'Initials': 'FM', 'LastName': 'Ssewamala', 'Affiliation': 'Brown School, Washington University in St. Louis, St. Louis, Missouri.'}]",The Journal of adolescent health : official publication of the Society for Adolescent Medicine,['10.1016/j.jadohealth.2020.07.022']
2972,32980788,Acceptability of real-time video counselling compared to other behavioural interventions for smoking cessation in rural and remote areas.,"BACKGROUND


This study evaluated the acceptability of real-time video counselling compared to a) telephone counselling and b) written materials in assisting rural and remote residents to quit smoking.
METHODS


Participants were recruited into a three-arm, parallel group randomised trial and randomly allocated to either: a) real-time video counselling; b) telephone counselling; or c) written materials. At 4-months post-baseline participants completed an online survey that examined self-reported acceptability and helpfulness of the support.
RESULTS


Overall, 93.5 % of video counselling participants and 96.2 % of telephone counselling participants who received support thought it was acceptable for a smoking cessation advisor to contact them via video software or telephone respectively. There were significant differences between video counselling and telephone counselling groups on three of 10 acceptability or helpfulness measures. Video counselling participants had significantly lower odds of reporting the number of calls were about right (OR 0.50, 95 % CI 0.27-0.93), recommending the support to family and friends (OR 0.18, 95 % CI 0.04-0.85) and reporting the support helped with motivation to try quitting (OR 0.24, 95 % CI 0.07-0.76) compared to telephone counselling participants. Video counselling participants had significantly greater odds than written materials participants of rating the support favourably on all seven acceptability and helpfulness items compared.
CONCLUSIONS


Real-time video counselling for smoking cessation is acceptable and well-received by those living in rural and remote locations. Further research is required to enhance the three attributes that were less acceptable for video counselling than telephone counselling.",2020,"Video counselling participants had significantly greater odds than written materials participants of rating the support favourably on all seven acceptability and helpfulness items compared.
","['Participants', 'smoking cessation in rural and remote areas', 'assisting rural and remote residents to quit smoking']","['behavioural interventions', 'real-time video counselling compared to a) telephone counselling and b) written materials', 'real-time video counselling; b) telephone counselling; or c) written materials', 'Video counselling', 'real-time video counselling', 'video counselling']",['number of calls'],"[{'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0520510', 'cui_str': 'Material'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1720420', 'cui_str': 'Call'}]",,0.115344,"Video counselling participants had significantly greater odds than written materials participants of rating the support favourably on all seven acceptability and helpfulness items compared.
","[{'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Byaruhanga', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, University Drive, Callaghan, New South Wales 2308 Australia; Hunter New England Population Health, Hunter New England Local Health District, Locked Mail Bag 10, Wallsend, New South Wales 2287 Australia; Hunter Medical Research Institute, Locked bag 1000, New Lambton, New South Wales 2305 Australia. Electronic address: Judith.byaruhanga@uon.edu.au.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Wiggers', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, University Drive, Callaghan, New South Wales 2308 Australia; Hunter New England Population Health, Hunter New England Local Health District, Locked Mail Bag 10, Wallsend, New South Wales 2287 Australia; Hunter Medical Research Institute, Locked bag 1000, New Lambton, New South Wales 2305 Australia.'}, {'ForeName': 'Christine L', 'Initials': 'CL', 'LastName': 'Paul', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, University Drive, Callaghan, New South Wales 2308 Australia; Hunter Medical Research Institute, Locked bag 1000, New Lambton, New South Wales 2305 Australia.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Byrnes', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, University Drive, Callaghan, New South Wales 2308 Australia; Hunter Medical Research Institute, Locked bag 1000, New Lambton, New South Wales 2305 Australia.'}, {'ForeName': 'Aimee', 'Initials': 'A', 'LastName': 'Mitchell', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, University Drive, Callaghan, New South Wales 2308 Australia; Hunter New England Population Health, Hunter New England Local Health District, Locked Mail Bag 10, Wallsend, New South Wales 2287 Australia.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Lecathelinais', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, University Drive, Callaghan, New South Wales 2308 Australia; Hunter New England Population Health, Hunter New England Local Health District, Locked Mail Bag 10, Wallsend, New South Wales 2287 Australia.'}, {'ForeName': 'Flora', 'Initials': 'F', 'LastName': 'Tzelepis', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, University Drive, Callaghan, New South Wales 2308 Australia; Hunter New England Population Health, Hunter New England Local Health District, Locked Mail Bag 10, Wallsend, New South Wales 2287 Australia; Hunter Medical Research Institute, Locked bag 1000, New Lambton, New South Wales 2305 Australia.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108296']
2973,32980853,Comparison of Effectiveness of Routine Antenatal Care with a Midwife-Managed Clinic Service in Prevention of Gestational Diabetes Mellitus in Early Pregnancy at a Hospital in China.,"BACKGROUND Women with normal fasting glucose (FPG) range (5.1 ≤FPG <6.09 mmol/L) in early pregnancy are at high risk of gestational diabetes mellitus (GDM). The aim of this study was to compare the effectiveness of routine antenatal care with a midwife-managed clinic service in the prevention of GDM in early pregnancy at a hospital in China. MATERIAL AND METHODS We designed a prospective observational clinical study among pregnancy women with normal fasting glucose (FPG) range (5.1 ≤FPG <6.09 mmol/L) in early pregnancy. Routine antenatal care was compared with a midwife-managed clinic service providing diet and exercise education before week 16. A 75-g OGTT was performed at weeks 24-28 for both groups. Results of OGTT and gestational weight gain were compared between the 2 groups. RESULTS Of the 592 eligible women, 296 women received the antenatal nursing clinic service and 296 were enrolled in a control group. Thirty-three women were lost to follow-up during the study, leaving 279 in the intervention group and 280 in the control group. Baseline demographic characteristics were similar between the 2 groups. GDM was diagnosed in 115 participants (41.2%) in the intervention group and 141 (50.4%) in the control group. Subgroup analysis showed a significantly lower rate of GDM in the intervention group among the No-IVF population (37.8% vs. 49.0%, P=0.01%). For pre-pregnancy BMI, significant differences were found in the incidence of GDM and maternal hypertension between the different groups, showing that the overweight group benefited most from the midwife-managed antenatal clinic service. CONCLUSIONS The midwife-managed clinic service was feasible and effective in the prevention of GDM.",2020,"For pre-pregnancy BMI, significant differences were found in the incidence of GDM and maternal hypertension between the different groups, showing that the overweight group benefited most from the midwife-managed antenatal clinic service.","['pregnancy women with normal fasting glucose (FPG) range (5.1 ≤FPG <6.09 mmol/L) in early pregnancy', 'Gestational Diabetes Mellitus in Early Pregnancy at a Hospital in China', '296 women received the antenatal nursing clinic service and 296 were enrolled in a control group', 'Thirty-three women were lost to follow-up during the study, leaving 279 in the intervention group and 280 in the control group', 'Women with normal fasting glucose (FPG) range (5.1 ≤FPG <6.09 mmol/L) in early pregnancy are at high risk of gestational diabetes mellitus (GDM', 'early pregnancy at a hospital in China', '592 eligible women']","['Routine Antenatal Care with a Midwife-Managed Clinic Service', 'routine antenatal care with a midwife-managed clinic service']","['incidence of GDM and maternal hypertension', 'rate of GDM', 'Baseline demographic characteristics', 'OGTT and gestational weight gain', 'GDM']","[{'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C1302313', 'cui_str': 'Lost to follow-up'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}]","[{'cui': 'C1276362', 'cui_str': 'Routine antenatal care'}, {'cui': 'C0026083', 'cui_str': 'Professional midwife'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0565599', 'cui_str': 'Maternal hypertension'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}]",592.0,0.0773553,"For pre-pregnancy BMI, significant differences were found in the incidence of GDM and maternal hypertension between the different groups, showing that the overweight group benefited most from the midwife-managed antenatal clinic service.","[{'ForeName': 'Jingbo', 'Initials': 'J', 'LastName': 'Qiu', 'Affiliation': 'Nursing Department, The International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai JiaoTong University, Shanghai, China (mainland).'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Nursing Department, The International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai JiaoTong University, Shanghai, China (mainland).'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhu', 'Affiliation': 'Nursing Department, The International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai JiaoTong University, Shanghai, China (mainland).'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Research and Education Department, The International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai JiaoTong University, Shanghai, China (mainland).'}]",Medical science monitor : international medical journal of experimental and clinical research,['10.12659/MSM.925991']
2974,32981695,Long-term safety in patients with recurrent ovarian cancer treated with niraparib versus placebo: Results from the phase III ENGOT-OV16/NOVA trial.,"OBJECTIVE


Niraparib is a poly(ADP-ribose) polymerase (PARP) inhibitor approved for use in heavily pretreated patients and as maintenance treatment in patients with newly-diagnosed or recurrent ovarian cancer following a response to platinum-based chemotherapy. We present long-term safety data for niraparib from the ENGOT-OV16/NOVA trial.
METHODS


This multicenter, double-blind, randomized, controlled phase III trial evaluated the efficacy and safety of niraparib for the treatment of recurrent ovarian cancer. Patients were randomly assigned 2:1 to receive either once-daily niraparib 300 mg or placebo. Two independent cohorts were enrolled based on germline BRCA mutation status. The primary endpoint was progression-free survival, reported previously. Long-term safety data were from the most recent data cutoff (September 2017).
RESULTS


Overall, 367 patients received niraparib 300 mg once daily. Dose reductions due to TEAEs were highest in month 1 (34%) and declined every month thereafter. Incidence of any-grade and grade ≥ 3 hematologic and symptomatic TEAEs was also highest in month 1 and subsequently declined. Incidence of grade ≥ 3 thrombocytopenia decreased from 28% (month 1) to 9% and 5% (months 2 and 3, respectively), with protocol-directed dose interruptions and/or reductions. Acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) were reported in 2 and 6 niraparib-treated patients, respectively, and in 1 placebo patient each. Treatment discontinuations due to TEAEs were <5% in each month and time interval measured.
CONCLUSION


These data demonstrate the importance of appropriate dose reduction according to toxicity criteria and support the safe long-term use of niraparib for maintenance treatment in patients with recurrent ovarian cancer.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT01847274.",2020,Incidence of any-grade and grade ≥ 3 hematologic and symptomatic TEAEs was also highest in month 1 and subsequently declined.,"['recurrent ovarian cancer', 'patients with recurrent ovarian cancer', 'patients with newly-diagnosed or recurrent ovarian cancer', '367 patients received', 'patients with recurrent ovarian cancer treated with']","['niraparib 300\xa0mg once daily', 'niraparib', 'niraparib versus placebo', 'once-daily niraparib 300\xa0mg or placebo', 'platinum-based chemotherapy']","['3 thrombocytopenia', 'efficacy and safety', 'Incidence of grade\xa0≥', 'Acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS', 'progression-free survival', 'Incidence of any-grade and grade\xa0≥\xa03 hematologic and symptomatic TEAEs']","[{'cui': 'C0278689', 'cui_str': 'Recurrent ovarian cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C2744440', 'cui_str': 'niraparib'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}]","[{'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}, {'cui': 'C2347761', 'cui_str': 'Childhood myelodysplastic syndrome'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0018943', 'cui_str': 'Hematology'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}]",,0.360978,Incidence of any-grade and grade ≥ 3 hematologic and symptomatic TEAEs was also highest in month 1 and subsequently declined.,"[{'ForeName': 'Mansoor R', 'Initials': 'MR', 'LastName': 'Mirza', 'Affiliation': 'Nordic Society of Gynaecological Oncology Clinical Trial Unit (NSGO-CTU), Rigshospitalet-Copenhagen University Hospital, Copenhagen, Denmark. Electronic address: mansoor@rh.regionh.dk.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Benigno', 'Affiliation': 'Northside Hospital, Atlanta, GA, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Dørum', 'Affiliation': 'Radiumhospitalet, Oslo University Hospital, NSGO, Oslo, Norway.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Mahner', 'Affiliation': 'Department of Obstetrics and Gynecology, University Hospital, LMU Munich, AGO, Munich, Germany.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Bessette', 'Affiliation': 'Sherbrooke University, Sherbrooke, QC, Canada.'}, {'ForeName': 'I Bover', 'Initials': 'IB', 'LastName': 'Barceló', 'Affiliation': 'Hospital Son Llàtzer, GEICO, Palma de Mallorca, Spain.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Berton-Rigaud', 'Affiliation': ""Institut de Cancérologie de l'Ouest Centre René Gauducheau, GINECO, Saint-Herblain, France.""}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Ledermann', 'Affiliation': 'UCL Cancer Institute, University College London, NCRI, London, UK.'}, {'ForeName': 'B J', 'Initials': 'BJ', 'LastName': 'Rimel', 'Affiliation': 'Cedars-Sinai Medical Center, West Hollywood, CA, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Herrstedt', 'Affiliation': 'Odense University Hospital, Odense, Denmark; Zealand University Hospital, NSGO, Roskilde, Denmark.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Lau', 'Affiliation': 'McGill University, Montreal, QC, Canada.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'du Bois', 'Affiliation': 'Kliniken Essen Mitte, AGO, Essen, Germany.'}, {'ForeName': 'A Casado', 'Initials': 'AC', 'LastName': 'Herráez', 'Affiliation': 'Hospital Clínico San Carlos, GEICO, Madrid, Spain.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Kalbacher', 'Affiliation': 'Centre Hospitalier Régional et Universitaire de Besançon, GINECO, Besançon, France.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Buscema', 'Affiliation': 'Arizona Oncology Associates, Tucson, AZ, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Lorusso', 'Affiliation': 'Fondazione Policlinico Universitario a Gemelli IRCCS, Istituto Nazionale dei Tumori, MITO, Milan, Italy.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Vergote', 'Affiliation': 'University of Leuven, Leuven Cancer Institute, BGOG, Leuven, Belgium.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Levy', 'Affiliation': 'Wolfson Medical Center, ISGO, Holon, Israel.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Wang', 'Affiliation': 'GlaxoSmithKline, Waltham, MA, USA.'}, {'ForeName': 'F A', 'Initials': 'FA', 'LastName': 'de Jong', 'Affiliation': 'GlaxoSmithKline, Zug, Switzerland.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Gupta', 'Affiliation': 'GlaxoSmithKline, Waltham, MA, USA.'}, {'ForeName': 'U A', 'Initials': 'UA', 'LastName': 'Matulonis', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA, USA.'}]",Gynecologic oncology,['10.1016/j.ygyno.2020.09.006']
2975,32989771,A randomized clinical trial of a virtual-training program for teaching applied-behavior-analysis skills to parents of children with autism spectrum disorder.,"Parents play an important role in the treatment of their children's symptoms of autism spectrum disorder (ASD); thus, developing effective, efficient, socially acceptable, and accessible procedures for training parents to implement applied-behavior-analysis (ABA) interventions is critically important. One potential approach involves delivering training via a virtual private network (VPN) over the internet (Fisher et al., 2014). In this study, we conducted a randomized clinical trial to evaluate a virtual parent-training program with e-learning modules and scripted role-play via a VPN. We evaluated parent implementation of ABA skills using direct-observation measures in structured-work and play-based training contexts. Parents in the treatment group showed large, statistically significant improvements on all dependent measures; those in the waitlist-control group did not. Parents rated the training as highly socially acceptable. Results add to the growing literature on the efficacy and acceptability of virtually delivered training in ABA.",2020,"Parents in the treatment group showed large, statistically significant improvements on all dependent measures; those in the waitlist-control group did not.","['parents of children with autism spectrum disorder', ""children's symptoms of autism spectrum disorder (ASD""]","['virtual-training program', 'virtual parent-training program with e-learning modules and scripted role-play via a VPN']",['efficacy and acceptability'],"[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0033175', 'cui_str': 'Private Room'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",,0.0179069,"Parents in the treatment group showed large, statistically significant improvements on all dependent measures; those in the waitlist-control group did not.","[{'ForeName': 'Wayne W', 'Initials': 'WW', 'LastName': 'Fisher', 'Affiliation': 'Rutgers University Robert Wood Johnson Medical School.'}, {'ForeName': 'Kevin C', 'Initials': 'KC', 'LastName': 'Luczynski', 'Affiliation': ""The University of Nebraska Medical Center's Monroe-Meyer Institute.""}, {'ForeName': 'Andrew P', 'Initials': 'AP', 'LastName': 'Blowers', 'Affiliation': ""The University of Nebraska Medical Center's Monroe-Meyer Institute.""}, {'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Vosters', 'Affiliation': 'University of Houston, Clear Lake.'}, {'ForeName': 'Maegan D', 'Initials': 'MD', 'LastName': 'Pisman', 'Affiliation': ""The University of Nebraska Medical Center's Monroe-Meyer Institute.""}, {'ForeName': 'Andy R', 'Initials': 'AR', 'LastName': 'Craig', 'Affiliation': 'Upstate Medical Center.'}, {'ForeName': 'Stephanie A', 'Initials': 'SA', 'LastName': 'Hood', 'Affiliation': 'Marquette University.'}, {'ForeName': 'Mychal A', 'Initials': 'MA', 'LastName': 'Machado', 'Affiliation': 'University of Alaska Anchorage.'}, {'ForeName': 'Aaron D', 'Initials': 'AD', 'LastName': 'Lesser', 'Affiliation': ""The University of Nebraska Medical Center's Monroe-Meyer Institute.""}, {'ForeName': 'Cathleen C', 'Initials': 'CC', 'LastName': 'Piazza', 'Affiliation': 'Rutgers University School of Applied and Professional Psychology.'}]",Journal of applied behavior analysis,['10.1002/jaba.778']
2976,32992190,Dual Antiplatelet Therapy Beyond 90 days in Symptomatic Intracranial Stenosis in the SAMMPRIS Trial.,"BACKGROUND


The safety and efficacy of dual antiplatelet use for symptomatic intracranial atherosclerosis beyond 90 days is unknown. Data from SAMMPRIS was used to determine if dual antiplatelet therapy (DAPT) beyond 90 days impacted the risk of ischemic stroke and hemorrhage.
METHODS


This post hoc exploratory analysis from SAMMPRIS included patients who did not have a primary endpoint within 90 days after enrollment (n = 397). Patients in both the aggressive medical management (AMM) and percutaneous transluminal angioplasty and stenting (PTAS) arms were included. Baseline features and outcomes during follow-up were compared between patients who remained on DAPT beyond 90 days (on clopidogrel) and patients who discontinued clopidogrel and remained on aspirin alone at 90 days (off clopidogrel) using Fisher's exact tests.
RESULTS


The stroke rate was numerically lower in the group on clopidogrel vs off clopidogrel among both the AMM alone arm (6.0% versus 10.8%, p = 0.31) and the PTAS arm (8.7% versus 9.8%; p = 0.82), but the difference was not significant. The major hemorrhage rates were numerically higher in the group on clopidogrel vs. off clopidogrel group among both the AMM alone arm (4.0% versus 2.5%; p = 0.67) and the PTAS arm (10.9% versus 3.5%; p = 0.08), but were not significant.
CONCLUSION


This exploratory analysis suggests that prolonged DAPT use may lower the risk of stroke in medically treated patients with intracranial stenosis but may increase the risk of major hemorrhage.",2020,"The major hemorrhage rates were numerically higher in the group on clopidogrel vs. off clopidogrel group among both the AMM alone arm (4.0% versus 2.5%; p = 0.67) and the PTAS arm (10.9% versus 3.5%; p = 0.08), but were not significant.
",['patients who did not have a primary endpoint within 90 days after enrollment (n\xa0=\xa0397'],"['aggressive medical management (AMM) and percutaneous transluminal angioplasty and stenting (PTAS', 'Dual Antiplatelet Therapy', 'clopidogrel', 'aspirin']","['stroke rate', 'major hemorrhage rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}]","[{'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C2936666', 'cui_str': 'Percutaneous transluminal angioplasty'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}]","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",397.0,0.0576875,"The major hemorrhage rates were numerically higher in the group on clopidogrel vs. off clopidogrel group among both the AMM alone arm (4.0% versus 2.5%; p = 0.67) and the PTAS arm (10.9% versus 3.5%; p = 0.08), but were not significant.
","[{'ForeName': 'Line', 'Initials': 'L', 'LastName': 'Abdul Rahman', 'Affiliation': 'Department of Neurology, 96 Jonathan Lucas Street, Clinical Science Building 301, MSC 606, Medical University of South Carolina, Charleston 29425-8050, SC, United States. Electronic address: abdulara@musc.edu.'}, {'ForeName': 'Tanya N', 'Initials': 'TN', 'LastName': 'Turan', 'Affiliation': 'Department of Neurology, 96 Jonathan Lucas Street, Clinical Science Building 301, MSC 606, Medical University of South Carolina, Charleston 29425-8050, SC, United States. Electronic address: turan@musc.edu.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Cotsonis', 'Affiliation': 'Department of Biostatistics and Bioinformatics, 1518 Clifton Rd, Emory University Rollins School of Public Health, Atlanta 30322, GA, United States. Electronic address: gcotson@emory.edu.'}, {'ForeName': 'Eyad', 'Initials': 'E', 'LastName': 'Almallouhi', 'Affiliation': 'Department of Neurology, 96 Jonathan Lucas Street, Clinical Science Building 301, MSC 606, Medical University of South Carolina, Charleston 29425-8050, SC, United States. Electronic address: almallou@musc.edu.'}, {'ForeName': 'Christine A', 'Initials': 'CA', 'LastName': 'Holmstedt', 'Affiliation': 'Department of Neurology, 96 Jonathan Lucas Street, Clinical Science Building 301, MSC 606, Medical University of South Carolina, Charleston 29425-8050, SC, United States. Electronic address: holmsted@musc.edu.'}, {'ForeName': 'Marc I', 'Initials': 'MI', 'LastName': 'Chimowitz', 'Affiliation': 'Department of Neurology, 96 Jonathan Lucas Street, Clinical Science Building 301, MSC 606, Medical University of South Carolina, Charleston 29425-8050, SC, United States. Electronic address: mchimow@musc.edu.'}]",Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association,['10.1016/j.jstrokecerebrovasdis.2020.105254']
2977,32992206,Impact of a Pre-Discharge Education Session on Stroke Knowledge: a Randomized Trial.,"BACKGROUND AND PURPOSES


Stroke knowledge, awareness of risk factors and stroke warning symptoms is very poor among stroke survivors. We investigated whether a pre-discharge education intervention in the stroke unit could improve stroke knowledge in patients with TIA or minor stroke.
METHODS


We performed a prospective single-center, randomized controlled trial (2013-2016) in patients with TIA or minor stroke. The intervention consisted in an interactive group session focused on stroke education, within the stroke unit before hospital discharge. Primary outcome was the 3-month change in stroke knowledge score (SKS) from randomization. Secondary outcomes were the 12-month change in SKS, the number of risk factors and warning signs named, control of risk factors and self-reported adherence.
RESULTS


A total of 199 patients (mean [SD] age, 63.5 [12.4] years; 67 [33.7%] women) were randomized (99 in stroke education session). Intervention was associated with a greater improvement in SKS than in the control group (baseline-adjusted mean between-group difference, 1.6 point [95%CI, 1.4 to 1.9]; p=0.001). This difference was significantly maintained at 12 months. The number of risk factors and warning signs named were significantly increased in the intervention group at 3 months. Control of risk factors and self-reported adherence did not differ significantly between the two groups.
CONCLUSIONS


An interactive education session in the stroke unit significantly improved stroke knowledge at 3 months and 12 months in patients with TIA or minor stroke.",2020,"Intervention was associated with a greater improvement in SKS than in the control group (baseline-adjusted mean between-group difference, 1.6 point [95%CI, 1.4 to 1.9]; p=0.001).","['patients with TIA or minor stroke', '199 patients (mean [SD] age, 63.5 [12.4] years; 67 [33.7%] women']","['Pre-Discharge Education Session', 'pre-discharge education intervention']","['number of risk factors and warning signs named', 'SKS', '3-month change in stroke knowledge score (SKS', 'stroke knowledge', '12-month change in SKS, the number of risk factors and warning signs named, control of risk factors and self-reported adherence', 'Stroke Knowledge']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517543', 'cui_str': '12.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0027365', 'cui_str': 'Name'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",199.0,0.144626,"Intervention was associated with a greater improvement in SKS than in the control group (baseline-adjusted mean between-group difference, 1.6 point [95%CI, 1.4 to 1.9]; p=0.001).","[{'ForeName': 'Charline', 'Initials': 'C', 'LastName': 'Benoit', 'Affiliation': 'Department of Stroke Center and Diagnostic and Interventional Neuroradiology, Foch Hospital, University Versailles Saint-Quentin en Yvelines, Suresnes, France. Electronic address: charline.benoit@aphp.fr.'}, {'ForeName': 'Delphine', 'Initials': 'D', 'LastName': 'Lopez', 'Affiliation': 'Department of Stroke Center and Diagnostic and Interventional Neuroradiology, Foch Hospital, University Versailles Saint-Quentin en Yvelines, Suresnes, France.'}, {'ForeName': 'Murielle', 'Initials': 'M', 'LastName': 'Loiseau', 'Affiliation': 'Department of Stroke Center and Diagnostic and Interventional Neuroradiology, Foch Hospital, University Versailles Saint-Quentin en Yvelines, Suresnes, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Labreuche', 'Affiliation': 'Univ.Lille, CHU Lille, EA 2694-Santé Publique:Épidémiologie et Qualité des Soins, F-59000 Lille, France.'}, {'ForeName': 'Maeva', 'Initials': 'M', 'LastName': 'Kyheng', 'Affiliation': 'Univ.Lille, CHU Lille, EA 2694-Santé Publique:Épidémiologie et Qualité des Soins, F-59000 Lille, France.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Bourdain', 'Affiliation': 'Department of Stroke Center and Diagnostic and Interventional Neuroradiology, Foch Hospital, University Versailles Saint-Quentin en Yvelines, Suresnes, France.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Lapergue', 'Affiliation': 'Department of Stroke Center and Diagnostic and Interventional Neuroradiology, Foch Hospital, University Versailles Saint-Quentin en Yvelines, Suresnes, France.'}]",Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association,['10.1016/j.jstrokecerebrovasdis.2020.105272']
2978,32992268,Training with tarantulas: A randomized feasibility and acceptability study using experiential learning to enhance exposure therapy training.,"BACKGROUND


Although exposure is a key evidence-based intervention for anxiety, it is infrequently used in clinical settings. This study employed a novel training strategy, experiential learning, to improve exposure implementation. This study aimed to assess the feasibility and acceptability of experiential training and preliminary training effectiveness.
METHODS


Participants were 28 therapists who were randomized to (a) training-as-usual or (b) experiential training (training-as-usual plus a one-session treatment for fear of spiders). Workshops lasted one day and were followed by three months of weekly consultation.
RESULTS


Experiential training was viewed as feasible and acceptable. Participants, including those who were fearful of spiders, had a positive response to the training and reported it to be useful. There was a significant increase in the number of exposures used by therapists receiving experiential training compared to training-as-usual at 1-month follow-up.
CONCLUSIONS


A one-day training resulted in significant improvements in knowledge, attitudes toward exposure, and self-efficacy in using exposure. Preliminary findings suggest that experiential training resulted in greater use of exposure post-training compared to training-as-usual. Results provide evidence for the feasibility and acceptability of experiential training as a strategy to increase the use of evidence-based interventions.",2020,Preliminary findings suggest that experiential training resulted in greater use of exposure post-training compared to training-as-usual.,['Participants were 28 therapists who were randomized to (a'],"['training-as-usual or (b) experiential training (training-as-usual plus a one-session treatment for fear of spiders', 'experiential learning to enhance exposure therapy training', 'experiential training']","['knowledge, attitudes toward exposure, and self-efficacy', 'number of exposures']",[],"[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0392331', 'cui_str': 'Arachnophobia'}, {'cui': 'C0243012', 'cui_str': 'Active Learning'}, {'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0454267', 'cui_str': 'Number of exposures'}]",28.0,0.02074,Preliminary findings suggest that experiential training resulted in greater use of exposure post-training compared to training-as-usual.,"[{'ForeName': 'Hannah E', 'Initials': 'HE', 'LastName': 'Frank', 'Affiliation': 'Department of Psychology, Temple University, 1701 N 13th St., Philadelphia, PA, 19122, USA. Electronic address: hannah.frank@temple.edu.'}, {'ForeName': 'Emily M', 'Initials': 'EM', 'LastName': 'Becker-Haimes', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, 3535 Market Street, 3rd Floor, Philadelphia, PA, 19104, USA; Hall-Mercer Community Mental Health Center, 245 S. 8th St., Philadelphia, PA, 19107, USA.'}, {'ForeName': 'Lara S', 'Initials': 'LS', 'LastName': 'Rifkin', 'Affiliation': 'Department of Psychology, Temple University, 1701 N 13th St., Philadelphia, PA, 19122, USA.'}, {'ForeName': 'Lesley A', 'Initials': 'LA', 'LastName': 'Norris', 'Affiliation': 'Department of Psychology, Temple University, 1701 N 13th St., Philadelphia, PA, 19122, USA.'}, {'ForeName': 'Thomas H', 'Initials': 'TH', 'LastName': 'Ollendick', 'Affiliation': 'Child Study Center, Virginia Polytechnic Institute and State University, 460 Turner St., Suite 207, Blacksburg, VA, 24060, USA.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Olino', 'Affiliation': 'Department of Psychology, Temple University, 1701 N 13th St., Philadelphia, PA, 19122, USA.'}, {'ForeName': 'Hilary E', 'Initials': 'HE', 'LastName': 'Kratz', 'Affiliation': 'Department of Psychology, La Salle University, 1900 W. Olney Ave., Philadelphia, PA, 19141, USA.'}, {'ForeName': 'Rinad S', 'Initials': 'RS', 'LastName': 'Beidas', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, 3535 Market Street, 3rd Floor, Philadelphia, PA, 19104, USA; Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania, 423 Guardian Drive, Philadelphia, PA, 19104, USA; Penn Implementation Science Center at the Leonard David Institute of Health Economics (PISCE @LDI), 3641 Locust Walk, Philadelphia, PA, 19104, USA.'}, {'ForeName': 'Philip C', 'Initials': 'PC', 'LastName': 'Kendall', 'Affiliation': 'Department of Psychology, Temple University, 1701 N 13th St., Philadelphia, PA, 19122, USA.'}]",Journal of anxiety disorders,['10.1016/j.janxdis.2020.102308']
2979,32997095,Five-Year Health Status After Self-expanding Transcatheter or Surgical Aortic Valve Replacement in High-risk Patients With Severe Aortic Stenosis.,"Importance


In the CoreValve High-Risk Trial, patients with severe symptomatic aortic stenosis had similar clinical outcomes with transcatheter aortic valve replacement (TAVR) vs surgical aortic valve replacement (SAVR) over 5 years of follow-up, with mortality rates of more than 50% in both groups.
Objective


To describe the long-term health status of surviving patients randomized to self-expanding TAVR vs SAVR.
Design, Setting, and Participants


This randomized clinical trial included patients at high surgical risk with severe aortic stenosis who completed a baseline Kansas City Cardiomyopathy Questionnaire (KCCQ) and were randomized to either self-expanding TAVR or SAVR from 45 US clinical sites. Patients were enrolled from February 2011 to September 2012. Analysis began May 2018 and ended June 2020.
Main Outcomes and Measures


Change in KCCQ and the 12-Item Short-Form Health Survey over 5 years, as assessed by repeated-measures analysis of covariance. Because there were significant interactions between access site and treatment for 1-month health status outcomes, all analyses were stratified by access site (iliofemoral or noniliofemoral).
Results


Of 713 patients, 377 (53%) were men, and the mean (SD) age was 83 (7) years. Prior to treatment, the mean (SD) KCCQ overall summary score (range, 0-100; higher score indicated better health status) was 47 (23), indicating substantial health status impairment. Among surviving patients, the KCCQ overall summary score increased significantly in both groups with greater early benefit with iliofemoral TAVR than SAVR (1-month difference, 16.8 points; 95% CI, 12.4-21.2). However, this early treatment difference between TAVR and SAVR was no longer apparent by 6 months, and there was no significant difference in health status between groups thereafter. At 5 years, 44% (134 of 305) of patients who underwent iliofemoral TAVR and 39% (105 of 266) who underwent SAVR were alive in this high-risk elderly cohort. Among surviving patients for whom health status data were available, 61% (48 of 79) in the TAVR group and 65% (46 of 71) in the SAVR group had KCCQ overall summary score more than 60 (P = .61). In the noniliofemoral cohort, there were no significant health status differences at any time between TAVR and SAVR. Results were similar for individual KCCQ domains and the Short-Form Health Survey.
Conclusions and Relevance


In high-risk patients with severe symptomatic aortic stenosis, there was an early health status benefit with self-expanding iliofemoral TAVR vs SAVR but no difference between groups in long-term health status. Although mortality at 5 years was high in this population, the majority of surviving patients continued to report reasonable health status.
Trial Registration


ClinicalTrials.gov Identifier: NCT01240902.",2020,"Among surviving patients, the KCCQ overall summary score increased significantly in both groups with greater early benefit with iliofemoral TAVR than SAVR (1-month difference, 16.8 points; 95% CI, 12.4-21.2).","['Patients were enrolled from February 2011 to September 2012', '713 patients, 377 (53%) were men, and the mean (SD) age was 83 (7) years', 'high-risk patients with severe symptomatic aortic stenosis', 'patients with severe symptomatic aortic stenosis', 'High-risk Patients With Severe Aortic Stenosis', 'patients at high surgical risk with severe aortic stenosis who completed a baseline Kansas City Cardiomyopathy Questionnaire (KCCQ']","['transcatheter aortic valve replacement (TAVR) vs surgical aortic valve replacement (SAVR', 'self-expanding TAVR vs SAVR', 'Self-expanding Transcatheter or Surgical Aortic Valve Replacement', 'self-expanding TAVR or SAVR', 'iliofemoral TAVR']","['mean (SD) KCCQ overall summary score', 'mortality rates', 'Measures\n\n\nChange in KCCQ and the 12-Item Short-Form Health Survey', 'KCCQ overall summary score', 'TAVR and SAVR', 'health status']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0003507', 'cui_str': 'Aortic valve stenosis'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0022497', 'cui_str': 'Kansas'}]","[{'cui': 'C2711836', 'cui_str': 'Percutaneous replacement of aortic valve using fluoroscopic guidance'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0003506', 'cui_str': 'Replacement of aortic valve'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205229', 'cui_str': 'Expanding'}, {'cui': 'C0442343', 'cui_str': 'Transcatheter approach'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0022497', 'cui_str': 'Kansas'}, {'cui': 'C2711836', 'cui_str': 'Percutaneous replacement of aortic valve using fluoroscopic guidance'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0003506', 'cui_str': 'Replacement of aortic valve'}, {'cui': 'C0018759', 'cui_str': 'Health status'}]",,0.0850731,"Among surviving patients, the KCCQ overall summary score increased significantly in both groups with greater early benefit with iliofemoral TAVR than SAVR (1-month difference, 16.8 points; 95% CI, 12.4-21.2).","[{'ForeName': 'Suzanne V', 'Initials': 'SV', 'LastName': 'Arnold', 'Affiliation': ""Saint Luke's Mid America Heart Institute, Kansas City, Missouri.""}, {'ForeName': 'Khaja M', 'Initials': 'KM', 'LastName': 'Chinnakondepalli', 'Affiliation': ""Saint Luke's Mid America Heart Institute, Kansas City, Missouri.""}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Magnuson', 'Affiliation': ""Saint Luke's Mid America Heart Institute, Kansas City, Missouri.""}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Reardon', 'Affiliation': 'Houston-Methodist-DeBakey Heart and Vascular Center, Houston, Texas.'}, {'ForeName': 'G Michael', 'Initials': 'GM', 'LastName': 'Deeb', 'Affiliation': 'University of Michigan Hospitals, Ann Arbor.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Gleason', 'Affiliation': 'University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Yakubov', 'Affiliation': 'Riverside Methodist-Ohio Health, Columbus.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Cohen', 'Affiliation': 'University of Missouri-Kansas City, Kansas City.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA cardiology,['10.1001/jamacardio.2020.4397']
2980,32997098,Rivaroxaban and Aspirin in Patients With Symptomatic Lower Extremity Peripheral Artery Disease: A Subanalysis of the COMPASS Randomized Clinical Trial.,"Importance


Patients with symptomatic lower extremity peripheral artery disease (LE-PAD) experience an increased risk of major vascular events. There is limited information on what clinical features of symptomatic LE-PAD prognosticate major vascular events and whether patients at high risk have a greater absolute benefit from low-dose rivaroxaban and aspirin.
Objective


To quantify the risk of major vascular events and investigate the response to treatment with low-dose rivaroxaban and aspirin among patients with symptomatic LE-PAD based on clinical presentation and comorbidities.
Design, Setting, and Participants


This is a subanalysis of a previously reported subgroup of patients with symptomatic LE-PAD who were enrolled in a large, double-blind, placebo-controlled randomized clinical trial (Cardiovascular Outcomes for People Using Anticoagulation Strategies [COMPASS]) in 602 centers in 33 countries from March 2013 to January 2020. Data analysis was completed from May 2016 to June 2020.
Interventions


A combination of low-dose rivaroxaban and aspirin compared with aspirin alone.
Main Outcomes and Measures


Thirty-month incidence risk of myocardial infarction, stroke and cardiovascular death (MACE), major adverse limb events (MALE) including major vascular amputation, and bleeding.
Results


The COMPASS trial enrolled 4129 patients with symptomatic LE-PAD (mean [SD] age, 66.8 [8.8] years; 2932 men [71.0%]). The 30-month Kaplan-Meier incidence risk of MACE or MALE, including major amputation, was 22.6% in those with prior amputation (this outcome was observed in 54 patients), 17.6% (n = 15) in those with Fontaine III or IV symptoms, and 11.8% (n = 142) in those with previous peripheral artery revascularization, classifying these features as high-risk limb presentations. The 30-month incidence risk of MACE or MALE, including major amputation, was 14.1% (n = 118) in those with kidney dysfunction, 13.5% (n = 67) in those with heart failure, 13.4% (n = 199) in those with diabetes, and 12.8% (n = 222) in those with polyvascular disease, classifying these features as high-risk comorbidities. Among patients with either high-risk limb presentations or high-risk comorbidities, treatment with rivaroxaban and aspirin compared with aspirin alone was associated with an estimated 4.2% (95% CI, 1.9%-6.2%) absolute risk reduction for MACE or MALE, including major amputation, at 30 months. Although the estimated absolute risk increase of major bleeding was higher with rivaroxaban and aspirin in combination than aspirin alone (2.0% [95% CI, 0.5%-3.9%]) for patients with either high-risk limb presentation or high-risk comorbidity, the estimated absolute risk increase of fatal or critical organ bleeding was low in this high-risk group (0.4% [95% CI, 0.2%-1.8%]), such that the net clinical benefit was estimated to be 3.2% (95% CI, 0.6%-5.3%).
Conclusions and Relevance


Patients with LE-PAD with high-risk limb presentations or high-risk comorbidities had a high incidence of major vascular events. For these patients, treatment with rivaroxaban and aspirin in combination compared with aspirin alone led to a large absolute reduction in vascular risk.",2020,"Although the estimated absolute risk increase of major bleeding was higher with rivaroxaban and aspirin in combination than aspirin alone (2.0% [95% CI, 0.5%-3.9%]) for patients with either high-risk limb presentation or high-risk comorbidity, the estimated absolute risk increase of fatal or critical organ bleeding was low in this high-risk group (0.4% [95% CI, 0.2%-1.8%]), such that the net clinical benefit was estimated to be 3.2% (95% CI, 0.6%-5.3%).
","['602 centers in 33 countries from March 2013 to January 2020', 'patients with symptomatic LE-PAD', 'patients with either high-risk limb presentations or high-risk comorbidities, treatment with', 'patients with symptomatic LE-PAD based on clinical presentation and comorbidities', 'Importance\n\n\nPatients with symptomatic lower extremity peripheral artery disease (LE-PAD', '4129 patients with symptomatic LE-PAD (mean [SD] age, 66.8 [8.8] years; 2932 men [71.0', 'Patients With Symptomatic Lower Extremity Peripheral Artery Disease']","['rivaroxaban', 'Rivaroxaban and Aspirin', 'placebo', 'aspirin alone', 'aspirin', 'rivaroxaban and aspirin', 'Anticoagulation Strategies [COMPASS']","['net clinical benefit', '30-month incidence risk of MACE or MALE, including major amputation', 'fatal or critical organ bleeding', 'major bleeding', 'vascular risk', 'Main Outcomes and Measures\n\n\nThirty-month incidence risk of myocardial infarction, stroke and cardiovascular death (MACE), major adverse limb events (MALE) including major vascular amputation, and bleeding']","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Arterial Diseases'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517844', 'cui_str': '66.8'}, {'cui': 'C4517882', 'cui_str': '8.8'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C3816446', 'cui_str': '30'}]",4129.0,0.189312,"Although the estimated absolute risk increase of major bleeding was higher with rivaroxaban and aspirin in combination than aspirin alone (2.0% [95% CI, 0.5%-3.9%]) for patients with either high-risk limb presentation or high-risk comorbidity, the estimated absolute risk increase of fatal or critical organ bleeding was low in this high-risk group (0.4% [95% CI, 0.2%-1.8%]), such that the net clinical benefit was estimated to be 3.2% (95% CI, 0.6%-5.3%).
","[{'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Kaplovitch', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton Health Sciences, Hamilton, Ontario, Canada.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Eikelboom', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton Health Sciences, Hamilton, Ontario, Canada.'}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Dyal', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton Health Sciences, Hamilton, Ontario, Canada.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Aboyans', 'Affiliation': 'Department of Cardiology, Dupuytren University Hospital, Limoges, France.'}, {'ForeName': 'Maria Teresa', 'Initials': 'MT', 'LastName': 'Abola', 'Affiliation': 'College of Medicine, University of the Philippines/Philippine Heart Center, Manila, Philippines.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Verhamme', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leuven, Leuven, Belgium.'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Avezum', 'Affiliation': 'International Research Center, Hospital Alemão Oswaldo Cruz, São Paulo, Brazil.'}, {'ForeName': 'Keith A A', 'Initials': 'KAA', 'LastName': 'Fox', 'Affiliation': 'Department of Cardiology, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Berkowitz', 'Affiliation': 'Clinical Development, Thrombosis & Vascular Medicine, Bayer US LLC, Whippany, New Jersey.'}, {'ForeName': 'Shrikant I', 'Initials': 'SI', 'LastName': 'Bangdiwala', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton Health Sciences, Hamilton, Ontario, Canada.'}, {'ForeName': 'Salim', 'Initials': 'S', 'LastName': 'Yusuf', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton Health Sciences, Hamilton, Ontario, Canada.'}, {'ForeName': 'Sonia S', 'Initials': 'SS', 'LastName': 'Anand', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton Health Sciences, Hamilton, Ontario, Canada.'}]",JAMA cardiology,['10.1001/jamacardio.2020.4390']
2981,32994239,"Thymosin alpha 1 in the prevention of infected pancreatic necrosis following acute necrotising pancreatitis (TRACE trial): protocol of a multicentre, randomised, double-blind, placebo-controlled, parallel-group trial.","INTRODUCTION


Infected pancreatic necrosis (IPN) and its related septic complications are the major causes of death in patients with acute necrotising pancreatitis (ANP). Therefore, the prevention of IPN is of great clinical value, and immunomodulatory therapy with thymosin alpha 1 may be beneficial. This study was designed to test the hypothesis that the administration of thymosin alpha 1 during the acute phase of ANP will result in a reduced incidence of IPN.
METHODS AND ANALYSIS


This is a randomised, multicentre, double-blind, placebo-controlled study. 520 eligible patients with ANP will be randomised in a 1:1 ratio to receive either the thymosin alpha 1 or the placebo using the same mode of administration. The primary endpoint is the incidence of IPN during the index admission. Most of the secondary endpoints will be registered within the index admission including in-hospital mortality, the incidence of new-onset organ failure and new-onset persistent organ failure (respiration, cardiovascular and renal), receipt of new organ support therapy, requirement for drainage or necrosectomy, bleeding requiring intervention, human leucocyte antigens-DR(HLA-DR) on day 0, day 7, day 14, and so on and adverse events. Considering the possibility of readmission, an additional follow-up will be arranged 90 days after enrolment, and IPN and death at day 90 will also be served as secondary outcomes.
ETHICS AND DISSEMINATION


This study was approved by the ethics committee of Jinling Hospital, Nanjing University (Number 2015NZKY-004-02). The thymosin alpha 1 in the prevention of infected pancreatic necrosis following acute necrotising pancreatitis(TRACE) trial was designed to test the effect of a new therapy focusing on the immune system in preventing secondary infection following ANP. The results of this trial will be disseminated in peer-reviewed journals and at scientific conferences.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov Registry (NCT02473406).",2020,The thymosin alpha 1 in the prevention of infected pancreatic necrosis following acute necrotising pancreatitis(TRACE) trial was designed to test the effect of a new therapy focusing on the immune system in preventing secondary infection following ANP.,"['520 eligible patients with ANP', 'patients with acute necrotising pancreatitis (ANP', 'Jinling Hospital, Nanjing University (Number 2015NZKY-004-02']","['thymosin alpha 1 or the placebo', 'placebo']","['incidence of IPN during the index admission', 'index admission including in-hospital mortality, the incidence of new-onset organ failure and new-onset persistent organ failure (respiration, cardiovascular and renal), receipt of new organ support therapy, requirement for drainage or necrosectomy, bleeding requiring intervention, human leucocyte antigens-DR(HLA-DR']","[{'cui': 'C4517803', 'cui_str': '520'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0030305', 'cui_str': 'Pancreatitis'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0237753', 'cui_str': 'Number'}]","[{'cui': 'C0076612', 'cui_str': 'thymalfasin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0341479', 'cui_str': 'Infected pancreatic necrosis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0349410', 'cui_str': 'Single organ dysfunction'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0344211', 'cui_str': 'Support'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C4761057', 'cui_str': 'Necrosectomy'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0019721', 'cui_str': 'HLA antigen'}, {'cui': 'C0023516', 'cui_str': 'Leukocyte'}, {'cui': 'C0003320', 'cui_str': 'Antigen'}]",520.0,0.490509,The thymosin alpha 1 in the prevention of infected pancreatic necrosis following acute necrotising pancreatitis(TRACE) trial was designed to test the effect of a new therapy focusing on the immune system in preventing secondary infection following ANP.,"[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Center of Severe Acute Pancreatitis (CSAP), Department of General Surgery, Jinling Hospital, Nanjing University Medical School, Nanjing, Jiangsu, China.'}, {'ForeName': 'Wenjian', 'Initials': 'W', 'LastName': 'Mao', 'Affiliation': 'Center of Severe Acute Pancreatitis (CSAP), Department of General Surgery, Jinling Hospital, Nanjing University Medical School, Nanjing, Jiangsu, China.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Ke', 'Affiliation': 'Center of Severe Acute Pancreatitis (CSAP), Department of General Surgery, Jinling Hospital, Nanjing University Medical School, Nanjing, Jiangsu, China kkb9832@gmail.com.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Chen', 'Affiliation': 'Tropical Clinical Trials Unit, Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, Liverpool, UK.'}, {'ForeName': 'Wenhua', 'Initials': 'W', 'LastName': 'He', 'Affiliation': 'Department of Gastroenterology, First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China.'}, {'ForeName': 'Xinting', 'Initials': 'X', 'LastName': 'Pan', 'Affiliation': 'Department of Emergency Intensive Care Unit, The Affiliated Hospital of Qingdao University, Qingdao, Shandong, China.'}, {'ForeName': 'Miao', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'Department of Intensive Care Unit, Affiliated Hospital of Zunyi Medical College, Zunyi, Guizhou, China.'}, {'ForeName': 'Chengjian', 'Initials': 'C', 'LastName': 'He', 'Affiliation': 'Department of Intensive Care Unit, Affiliated Nanhua Hospital, University of South China, Hengyang, Hunan, China.'}, {'ForeName': 'Weili', 'Initials': 'W', 'LastName': 'Gu', 'Affiliation': ""Department of Intensive care Unit, Nantong City No 1 People's Hospital and Second Affiliated Hospital of Nantong University, Nantong, Jiangsu, China.""}, {'ForeName': 'Jingyi', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Intensive Care Unit, Yijishan Hospital of Wannan Medical College, Wuhu, Anhui, China.'}, {'ForeName': 'Jingchun', 'Initials': 'J', 'LastName': 'Song', 'Affiliation': 'Department of Intensive Care Unit, 94th Hospital of PLA, Nanchang, Jiangxi, China.'}, {'ForeName': 'Haibin', 'Initials': 'H', 'LastName': 'Ni', 'Affiliation': 'Department of Emergency, Jiangsu Provincial Hospital of Integrated Chinese and Western Medicine, Nanjing, Jiangsu, China.'}, {'ForeName': 'Jianfeng', 'Initials': 'J', 'LastName': 'Tu', 'Affiliation': ""Department of Emergency Medicine, Zhejiang Provincial People's Hospital, Hangzhou, Zhejiang, China.""}, {'ForeName': 'Junli', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Department of Intensive Care Unit, Luoyang Center Hospital, Zhengzhou University, Zhengzhou, Henan, China.'}, {'ForeName': 'Guoxiu', 'Initials': 'G', 'LastName': 'Zhang', 'Affiliation': 'Department of Intensive Care Unit, Henan University of Science and Technology Affiliated First Hospital, Luoyang, Henan, China.'}, {'ForeName': 'Weiwei', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': ""Department of Gastroenterology, Yangzhou University Affiliated Northern Jiangsu People's Hospital, Yangzhou City, Jiangsu Province, China.""}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Xue', 'Affiliation': ""Department of Emergency Intensive Care Unit, Shangqiu First People's Hospital, Shangqiu, Henan, China.""}, {'ForeName': 'Xiangyang', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Department of Intensive Care Unit, Qilu Hospital of Shandong University Qingdao, Qingdao, Shandong, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Shao', 'Affiliation': 'Department of Intensive Care Unit, First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China.'}, {'ForeName': 'Yuxiu', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Medical Statistics, Jinling Hospital, Nanjing University Medical School, Nanjing, Jiangsu, China.'}, {'ForeName': 'Zhihui', 'Initials': 'Z', 'LastName': 'Tong', 'Affiliation': 'Center of Severe Acute Pancreatitis (CSAP), Department of General Surgery, Jinling Hospital, Nanjing University Medical School, Nanjing, Jiangsu, China.'}, {'ForeName': 'Weiqin', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Center of Severe Acute Pancreatitis (CSAP), Department of General Surgery, Jinling Hospital, Nanjing University Medical School, Nanjing, Jiangsu, China.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2020-037231']
2982,32983839,Pharmacist Interventions to Improve Specialty Medication Adherence: Study Protocol for a Randomized Controlled Trial.,"Background


The effectiveness of specialty medications in complicated clinical conditions depends on adherence to therapy. However, specialty medications pose unique barriers to adherence.
Objective


This study aims to determine whether pharmacist interventions improve specialty medication adherence.
Methods


This is a single-center, pragmatic, randomized controlled trial ongoing since 10 May 2019 at an integrated health system specialty pharmacy. This study evaluates usual care compared with usual care plus patient-tailored adherence interventions. Study design and procedures were informed by focus groups with patients and specialty pharmacists. Patients at Vanderbilt Specialty Pharmacy with a proportion of days covered (PDC) < 90% in the previous 4 months are identified by a daily query of the electronic pharmacy database. A pharmacist reviews these patients' electronic health records to identify and exclude ineligible patients. Eligible patients are randomized evenly to the control or intervention arm and stratified by historical clinic nonadherence rates. Patients randomized to the intervention arm undergo a baseline assessment to clarify reasons for nonadherence and subsequently receive patient-tailored interventions based on their specific reasons. Interventions and follow-up are provided at the discretion of the intervening pharmacist. The primary outcome is PDC calculated at 8 months post-enrollment. Enrollment of 438 participants will provide 90% power to detect a 5% difference in PDC between the two arms within each nonadherence risk stratum.
Discussion


This trial will evaluate the effect of patient-tailored interventions on specialty medication adherence and will inform how often and why patients are misidentified as nonadherent.
Registration


The trial was deemed a quality improvement initiative by the Vanderbilt University Institutional Review Board. It was registered in ClinicalTrials.gov (NCT03709277) on 17 October 2018.",2020,"Enrollment of 438 participants will provide 90% power to detect a 5% difference in PDC between the two arms within each nonadherence risk stratum.
","['10 May 2019 at an integrated health system specialty pharmacy', 'Patients at Vanderbilt Specialty Pharmacy with a proportion of days covered (PDC)\u2009<\u200990% in the previous 4\xa0months are identified by a daily query of the electronic pharmacy database', 'Eligible patients', '438 participants']","['pharmacist interventions', 'intervention arm undergo a baseline assessment to clarify reasons for nonadherence and subsequently receive patient-tailored interventions based on their specific reasons', 'patient-tailored interventions', 'usual care plus patient-tailored adherence interventions']","['Specialty Medication Adherence', 'PDC calculated', 'PDC']","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0037778', 'cui_str': 'Medical specialty'}, {'cui': 'C0031321', 'cui_str': 'Pharmacy service'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0439087', 'cui_str': '<90'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C3543841', 'cui_str': 'Query'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}]","[{'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]","[{'cui': 'C0037778', 'cui_str': 'Medical specialty'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}]",438.0,0.151243,"Enrollment of 438 participants will provide 90% power to detect a 5% difference in PDC between the two arms within each nonadherence risk stratum.
","[{'ForeName': 'Amanda M', 'Initials': 'AM', 'LastName': 'Kibbons', 'Affiliation': 'Vanderbilt Specialty Pharmacy, Vanderbilt University Medical Center, 726 Melrose Avenue, Nashville, TN 37211 USA.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Peter', 'Affiliation': 'Vanderbilt Specialty Pharmacy, Vanderbilt University Medical Center, 726 Melrose Avenue, Nashville, TN 37211 USA.'}, {'ForeName': 'Josh', 'Initials': 'J', 'LastName': 'DeClercq', 'Affiliation': 'The Department of Biostatistics, Vanderbilt University Medical Center, Nashville, TN USA.'}, {'ForeName': 'Leena', 'Initials': 'L', 'LastName': 'Choi', 'Affiliation': 'The Department of Biostatistics, Vanderbilt University Medical Center, Nashville, TN USA.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Bell', 'Affiliation': 'Vanderbilt Specialty Pharmacy, Vanderbilt University Medical Center, 726 Melrose Avenue, Nashville, TN 37211 USA.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Jolly', 'Affiliation': 'Vanderbilt Specialty Pharmacy, Vanderbilt University Medical Center, 726 Melrose Avenue, Nashville, TN 37211 USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Cherry', 'Affiliation': 'Vanderbilt Specialty Pharmacy, Vanderbilt University Medical Center, 726 Melrose Avenue, Nashville, TN 37211 USA.'}, {'ForeName': 'Bassel', 'Initials': 'B', 'LastName': 'Alhashemi', 'Affiliation': 'Vanderbilt Specialty Pharmacy, Vanderbilt University Medical Center, 726 Melrose Avenue, Nashville, TN 37211 USA.'}, {'ForeName': 'Nisha B', 'Initials': 'NB', 'LastName': 'Shah', 'Affiliation': 'Vanderbilt Specialty Pharmacy, Vanderbilt University Medical Center, 726 Melrose Avenue, Nashville, TN 37211 USA.'}, {'ForeName': 'Autumn D', 'Initials': 'AD', 'LastName': 'Zuckerman', 'Affiliation': 'Vanderbilt Specialty Pharmacy, Vanderbilt University Medical Center, 726 Melrose Avenue, Nashville, TN 37211 USA.'}]",Drugs - real world outcomes,['10.1007/s40801-020-00213-8']
2983,32986295,Treatment of faecal incontinence with autologous expanded mesenchymal stem cells: results of a pilot study.,"AIM


Management of faecal incontinence (FI) remains challenging because no definitive optimal treatment for this condition has yet been determined. Regenerative medicine could be an attractive therapeutic alternative for treating FI. Here, we aimed to determine the safety and feasibility of autologous expanded mesenchymal stem cells derived from adipose tissue (AdMSCs) in the treatment of patients diagnosed with structural FI.
METHOD


This was a randomized, multicentre, triple-blinded, placebo-controlled pilot study conducted at four sites in Spain with 16 adults with FI and a sphincter defect. Autologous AdMSCs were obtained from patients from surgically excised adipose tissue. These patients were intralesionally infused with a single dose of 4 × 10 7  AdMSCs or a placebo while under anaesthesia. We assessed the safety and feasibility of the treatment as the cumulative incidence of adverse events and the treatment efficacy using the Cleveland Clinic Faecal Incontinence Score, Faecal Incontinence Quality of Life score and Starck criteria to classify sphincter defects and anorectal physiology outcomes.
RESULTS


Adipose tissue extraction, cell isolation and intralesional infusion procedures were successful in all the patients. There was only one adverse event connected to adipose tissue extraction (a haematoma), and none was associated with the injection procedure. There were no significant differences in any of the assessed clinical, manometric or ultrasonographic parameters.
CONCLUSION


This study indicates that this infusion procedure in the anal sphincter is feasible and safe. However, it failed to demonstrate efficacy to treat patients with structural FI.",2020,There was only one adverse event connected to adipose tissue extraction (a hematoma) and none were associated with the injection procedure.,"['four sites in Spain in 16 adults with FI and a sphincter defect', 'patients diagnosed with structural FI']","['placebo', 'autologous expanded AdMSCs', 'autologous expanded mesenchymal stem cells']","['Cleveland Clinic Faecal Incontinence Score (CCFIS), Faecal Incontinence Quality of Life (FIQL) score, Starck criteria to classify sphincter defects, and anorectal physiology outcomes', 'clinical, manometric, or ultrasonographic parameters']","[{'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0205229', 'cui_str': 'Expanding'}, {'cui': 'C1257975', 'cui_str': 'Mesenchymal stem cell'}]","[{'cui': 'C0454845', 'cui_str': 'Cleveland'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0031842', 'cui_str': 'Physiology'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",16.0,0.111141,There was only one adverse event connected to adipose tissue extraction (a hematoma) and none were associated with the injection procedure.,"[{'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'de la Portilla', 'Affiliation': 'Coloproctology Clinical Management Unit, General and Gastrointestinal Surgery Division, Biomedical Research Institute (IBIS), Hospital Universitario Virgen del Rocio/CSIC University of Seville, Seville, Spain.'}, {'ForeName': 'José Luis', 'Initials': 'JL', 'LastName': 'Guerrero', 'Affiliation': 'Coloproctology Clinical Management Unit, General and Gastrointestinal Surgery Division, Biomedical Research Institute (IBIS), Hospital Universitario Virgen del Rocio/CSIC University of Seville, Seville, Spain.'}, {'ForeName': 'Maria Victoria', 'Initials': 'MV', 'LastName': 'Maestre', 'Affiliation': 'Coloproctology Clinical Management Unit, General and Gastrointestinal Surgery Division, Biomedical Research Institute (IBIS), Hospital Universitario Virgen del Rocio/CSIC University of Seville, Seville, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Leyva', 'Affiliation': 'GMP Cell Manufacturing Unit, Biomedical Research Institute of Malaga (IBIMA), Hospital Regional Universitario de Malaga, Málaga, Spain.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Mera', 'Affiliation': 'Coloproctology Unit Clinical Management, Unit of General Surgery Division, Hospital Regional Universitario de Málaga, Málaga, Spain.'}, {'ForeName': 'Damián', 'Initials': 'D', 'LastName': 'García-Olmo', 'Affiliation': 'Department of Surgery, University Hospital Fundación Jiménez Díaz, Madrid, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Rodríguez', 'Affiliation': 'GMP Cell Manufacturing Unit, Biomedical Research Institute of Malaga (IBIMA), Hospital Regional Universitario de Malaga, Málaga, Spain.'}, {'ForeName': 'Rosario', 'Initials': 'R', 'LastName': 'Mata', 'Affiliation': 'Andalusian Network for Design and Translation of Advanced Therapies, Seville, Spain.'}, {'ForeName': 'Fabiola', 'Initials': 'F', 'LastName': 'Lora', 'Affiliation': 'Andalusian Network for Design and Translation of Advanced Therapies, Seville, Spain.'}]",Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland,['10.1111/codi.15382']
2984,32980364,PROVIDE-HF primary results: Patient-Reported Outcomes inVestigation following Initiation of Drug therapy with Entresto (sacubitril/valsartan) in heart failure.,"BACKGROUND


In PARADIGM-HF, sacubitril/valsartan improved quality of life (QOL) versus enalapril in heart failure with reduced ejection fraction (HFrEF), yet limited data are available regarding QOL changes after sacubitril/valsartan initiation in routine practice.
METHODS


PROVIDE-HF was a prospective study within a national research network (Patient-Centered Outcomes Research Network) of HFrEF outpatients recently initiated on sacubitril/valsartan versus controls with recent angiotensin-converting enzyme inhibitor/angiotensin receptor blocker initiation/dose change. The primary end point was mean Kansas City Cardiomyopathy Questionnaire (KCCQ) change through 12 weeks. Other end points included responder analyses: ≥5-point and ≥20-point KCCQ increase. Adjusted QOL change was estimated after propensity score weighting.
RESULTS


Overall, 270 patients had both baseline and 12-week KCCQ data (151 sacubitril/valsartan; 119 control). The groups had similar demographics and HF details: median EF 28% and N-terminal pro-brain natriuretic peptide 1083 pg/mL. Sacubitril/valsartan patients had larger improvements in KCCQ (mean difference +4.76; P = .027) and were more likely to have a ≥5-point and ≥20-point response (all P < .05). Adjusted comparisons demonstrated similar numerical improvements in the change in KCCQ (+4.55; 95% CI -0.89 to 9.99; P = .101) and likelihood of ≥5-point increase (odds ratio 1.55; 95% CI: 0.84-2.86; P = .16); ≥20-point increase remained statistically significant (odds ratio 3.79; 95% CI 1.47-9.73; P = .006).
CONCLUSIONS


In this prospective HFrEF study of sacubitril/valsartan initiation compared with recent angiotensin-converting enzyme inhibitor/angiotensin receptor blocker initiation/dose change, the between-group difference in the primary end point, mean KCCQ change at 12 weeks was not statistically significant following adjustment, but sacubitril/valsartan initiation was associated with early improvements in QOL and a higher likelihood of ≥20-point improvement in KCCQ at 12 weeks. These data add additional real-world evidence related to patient-reported outcomes following the initiation of sacubitril/valsartan in routine clinical practice.",2020,The groups had similar demographics and HF details: median EF 28% and NT-proBNP 1083pg/mL. Sacubitril/valsartan patients had larger improvements in KCCQ (mean difference+4.76; P=.027) and were more likely to have a≥5-point and≥20-point response (all P<.05).,"['PROVIDE-HF was a prospective study within a national research network (PCORnet) of HFrEF outpatients', '270 patients had both baseline and 12-week KCCQ data (151 sacubitril/valsartan; 119 control', 'heart failure']","['sacubitril/valsartan', 'Entresto (Sacubitril/valsartan', 'sacubitril/valsartan vs. controls with recent ACE-I/ARB initiation/dose change', 'enalapril']","['quality of life (QOL', 'mean KCCQ change', 'KCCQ', 'Adjusted QOL change', 'mean Kansas City Cardiomyopathy Questionnaire (KCCQ) change through 12weeks']","[{'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0033522', 'cui_str': 'Prospective Studies'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C4319603', 'cui_str': '270'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C4033631', 'cui_str': 'valsartan and sacubitril'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]","[{'cui': 'C4033631', 'cui_str': 'valsartan and sacubitril'}, {'cui': 'C4033616', 'cui_str': 'Entresto'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0050385', 'cui_str': 'AC protocol'}, {'cui': 'C0521942', 'cui_str': 'Angiotensin II receptor antagonist'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0014025', 'cui_str': 'Enalapril'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0022497', 'cui_str': 'Kansas'}]",270.0,0.117334,The groups had similar demographics and HF details: median EF 28% and NT-proBNP 1083pg/mL. Sacubitril/valsartan patients had larger improvements in KCCQ (mean difference+4.76; P=.027) and were more likely to have a≥5-point and≥20-point response (all P<.05).,"[{'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Mentz', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC; Duke University School of Medicine, Durham, NC. Electronic address: robert.mentz@duke.edu.'}, {'ForeName': 'Haolin', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC.'}, {'ForeName': 'Emily C', 'Initials': 'EC', 'LastName': ""O'Brien"", 'Affiliation': 'Duke Clinical Research Institute, Durham, NC.'}, {'ForeName': 'Laine', 'Initials': 'L', 'LastName': 'Thomas', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC.'}, {'ForeName': 'Tamas', 'Initials': 'T', 'LastName': 'Alexy', 'Affiliation': 'University of Minnesota Health, Minneapolis, MN.'}, {'ForeName': 'Bhanu', 'Initials': 'B', 'LastName': 'Gupta', 'Affiliation': 'University of Kansas Medical Center, Kansas City, KS.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Vilaro', 'Affiliation': 'University of Florida, Gainesville, FL.'}, {'ForeName': 'Anuradha', 'Initials': 'A', 'LastName': 'Lala', 'Affiliation': 'Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Adam D', 'Initials': 'AD', 'LastName': 'DeVore', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC; Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Dhingra', 'Affiliation': 'University of Wisconsin, Madison, WI.'}, {'ForeName': 'Alexandros', 'Initials': 'A', 'LastName': 'Briasoulis', 'Affiliation': 'University of Iowa Hospitals and Clinics, Iowa City, IA.'}, {'ForeName': 'Marc A', 'Initials': 'MA', 'LastName': 'Simon', 'Affiliation': 'Pittsburgh Heart, Lung, Blood and Vascular Medicine Institute, McGowan Institute for Regenerative Medicine, Clinical and Translational Science Institute, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Stehlik', 'Affiliation': 'University of Utah School of Medicine, Salt Lake City, UT.'}, {'ForeName': 'Jo E', 'Initials': 'JE', 'LastName': 'Rodgers', 'Affiliation': 'UNC Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'Shannon M', 'Initials': 'SM', 'LastName': 'Dunlay', 'Affiliation': 'Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Abshire', 'Affiliation': 'Johns Hopkins School of Nursing, Baltimore, MD.'}, {'ForeName': 'Quinn S', 'Initials': 'QS', 'LastName': 'Wells', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Kurt G', 'Initials': 'KG', 'LastName': 'Barringhaus', 'Affiliation': 'University of South Carolina School of Medicine and WJB Dorn Veteran Affairs Medical Center, Columbia, SC.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Eckman', 'Affiliation': 'Minneapolis Heart Institute; Minneapolis, MN.'}, {'ForeName': 'Brian D', 'Initials': 'BD', 'LastName': 'Lowes', 'Affiliation': 'University of Nebraska Medical Center, Omaha, NE.'}, {'ForeName': 'Johana', 'Initials': 'J', 'LastName': 'Espinoza', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC.'}, {'ForeName': 'Rosalia', 'Initials': 'R', 'LastName': 'Blanco', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC.'}, {'ForeName': 'Xian', 'Initials': 'X', 'LastName': 'Shen', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ.'}, {'ForeName': 'Carol I', 'Initials': 'CI', 'LastName': 'Duffy', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ.'}, {'ForeName': 'Adrian F', 'Initials': 'AF', 'LastName': 'Hernandez', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC; Duke University School of Medicine, Durham, NC.'}]",American heart journal,['10.1016/j.ahj.2020.09.012']
2985,32980384,Postoperative radiotherapy with intensity-modulated radiation therapy versus 3-dimensional conformal radiotherapy in early breast cancer: A randomized clinical trial of KROG 15-03.,"PURPOSE


To investigate the safety and efficacy of intensity-modulated radiation therapy (IMRT) for early breast cancer compared with 3-dimensional conformal radiotherapy (3D-CRT) in a prospective and randomized trial.
METHODS AND MATERIALS


From March 2015 to February 2018, 693 patients with pT1-2N0M0 early breast cancer who underwent breast-conserving surgery were enrolled and randomly assigned into IMRT and 3D-CRT. The primary endpoint was 3-year locoregional recurrence-free survival (LRRFS). The secondary endpoints were recurrence-free survival, overall survival, acute toxicity, target coverage index, irradiation dose to organs at risk, and fatigue inventory. The radiation dose for the 3D-CRT arm was 59.4 Gy in 33 fractions for 6.5 weeks. It was 57.4 Gy in 28 fractions with simultaneous integrated boost for 5.5 weeks for the IMRT arm.
RESULTS


Of 693 patients, 349 and 344 patients received 3D-CRT and IMRT, respectively. There was no significant difference in LRRFS between the two arms. Conformity index of planning target volume was significantly superior in the IMRT arm than the 3D-CRT arm (p < 0.001). The mean lung dose and V 5 -V 50  for the ipsilateral lung were significantly lower in the IMRT arm than the 3D-CRT arm (all p < 0.05). The incidence of grade 2 or higher dermatitis was significantly lower in the IMRT arm (p = 0.009).
CONCLUSION


Compared to 3D-CRT, IMRT showed similar results in locoregional tumor control but superior results in planning target volume coverage. When IMRT is used in breast cancer, the irradiation dose to an ipsilateral lung and skin toxicity can be reduced.",2020,"Compared to 3D-CRT, IMRT showed similar results in locoregional tumor control but superior results in planning target volume coverage.","['693 patients', '349 and 344 patients received', 'From March 2015 to February 2018, 693 patients with pT1-2N0M0 early breast cancer who underwent breast-conserving surgery', 'early breast cancer']","['3D-CRT and IMRT', 'IMRT', '3-dimensional conformal radiotherapy (3D-CRT', 'IMRT and 3D-CRT', 'Postoperative radiotherapy with intensity-modulated radiation therapy versus 3-dimensional conformal radiotherapy', 'intensity-modulated radiation therapy (IMRT']","['Conformity index of planning target volume', 'incidence of grade 2 or higher dermatitis', 'LRRFS', '3-year locoregional recurrence-free survival (LRRFS', 'mean lung dose and V 5 -V 50  for the ipsilateral lung', 'recurrence-free survival, overall survival, acute toxicity, target coverage index, irradiation dose to organs at risk, and fatigue inventory']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0332391', 'cui_str': 'pT1 category'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0917927', 'cui_str': 'Breast conserving surgery'}]","[{'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0600521', 'cui_str': 'Conformal radiotherapy'}, {'cui': 'C1512814', 'cui_str': 'Intensity modulated radiation therapy'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}]","[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0454199', 'cui_str': 'Planning target volume'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0011603', 'cui_str': 'Dermatitis'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C2936599', 'cui_str': 'Organs at Risk'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",693.0,0.0805317,"Compared to 3D-CRT, IMRT showed similar results in locoregional tumor control but superior results in planning target volume coverage.","[{'ForeName': 'Kyu Hye', 'Initials': 'KH', 'LastName': 'Choi', 'Affiliation': ""Department of Radiation Oncology, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Sung Ja', 'Initials': 'SJ', 'LastName': 'Ahn', 'Affiliation': 'Department of Radiation Oncology, Chonnam National University Hospital, Chonnam National University School of Medicine, Gwangju, Republic of Korea.'}, {'ForeName': 'Jae Uk', 'Initials': 'JU', 'LastName': 'Jeong', 'Affiliation': 'Department of Radiation Oncology, Chonnam National University Hospital, Chonnam National University School of Medicine, Gwangju, Republic of Korea.'}, {'ForeName': 'Mina', 'Initials': 'M', 'LastName': 'Yu', 'Affiliation': ""Department of Radiation Oncology, Bucheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Jin Hee', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Department of Radiation Oncology, Dongsan Medical Center, Keimyung University School of Medicine, Daegu, Republic of Korea.'}, {'ForeName': 'Bae Kwon', 'Initials': 'BK', 'LastName': 'Jeong', 'Affiliation': 'Department of Radiation Oncology, Gyeongsang National University Hospital, Gyeongsang National University School of Medicine, Jinju, Republic of Korea.'}, {'ForeName': 'Joo Hwan', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': ""Department of Radiation Oncology, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Sung Hwan', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': ""Department of Radiation Oncology, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Jong Hoon', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': ""Department of Radiation Oncology, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea. Electronic address: koppul@catholic.ac.kr.""}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2020.09.043']
2986,32980586,Desire to drink as a function of laboratory-induced social stress among adolescents.,"BACKGROUND AND OBJECTIVES


Research consistently demonstrates a link between social anxiety and alcohol-related problems; however, the majority of work has been retrospective, and conducted with adults. Despite an extensive literature highlighting coping-related motives as an underlying mechanism, real-time work presents mixed findings, and no published research has examined an adolescent sample using experimental psychopathology techniques.
METHODS


The current study tested whether (1) history of social anxiety symptoms positively correlated with alcohol-related cognitions following laboratory-induced social stress, (2) state anxiety was positively correlated with alcohol-related cognitions, and (3) whether the nature of the stressor (performance versus rejection) impacted the strength of identified relations, in a sample of community-recruited adolescents reporting recent alcohol use. Participants (n = 114; M age  = 16.01; 64% girls) were randomly assigned to either a performance- or rejection-oriented task.
RESULTS


Findings indicated that history of social anxiety symptoms was positively correlated with state anxiety elicited by both tasks. Further, history of social anxiety symptoms was not related to change in desire to drink, but was positively related to the belief that alcohol 'would make me feel better.' State anxiety was positively related to both desire to drink and relief outcome expectancies across both tasks. Finally, the nature of the task did not moderate responding.
LIMITATIONS


Single site, community sampling confines interpretations, and the tasks did not fully perform as expected.
CONCLUSIONS


Further study is needed; however, the current findings support the contention that socially-oriented distress may be a developmentally-relevant, malleable target for prevention efforts aimed at problematic alcohol use among adolescents.",2020,State anxiety was positively related to both desire to drink and relief outcome expectancies across both tasks.,"['114; M age \xa0=\xa016.01; 64% girls', 'adolescents', 'Participants (n\xa0']",['performance- or rejection-oriented task'],"['history of social anxiety symptoms', 'State anxiety']","[{'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0035015', 'cui_str': 'Rejection (Psychology)'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}]","[{'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}]",,0.0194071,State anxiety was positively related to both desire to drink and relief outcome expectancies across both tasks.,"[{'ForeName': 'Heidemarie', 'Initials': 'H', 'LastName': 'Blumenthal', 'Affiliation': 'Department of Psychology, University of North Texas, 1155 Union Circle #311280, Denton, TX, 76203, United States. Electronic address: heidemarie.blumenthal@unt.edu.'}, {'ForeName': 'Renee M', 'Initials': 'RM', 'LastName': 'Cloutier', 'Affiliation': 'Department of Psychology, University of North Texas, 1155 Union Circle #311280, Denton, TX, 76203, United States. Electronic address: ReneeCloutier@my.unt.edu.'}, {'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Douglas', 'Affiliation': 'Department of Psychology, University of North Texas, 1155 Union Circle #311280, Denton, TX, 76203, United States. Electronic address: MeganDouglas@my.unt.edu.'}, {'ForeName': 'Nathan T', 'Initials': 'NT', 'LastName': 'Kearns', 'Affiliation': 'Department of Psychology, University of North Texas, 1155 Union Circle #311280, Denton, TX, 76203, United States. Electronic address: NathanKearns@my.unt.edu.'}, {'ForeName': 'Caitlyn N', 'Initials': 'CN', 'LastName': 'Carey', 'Affiliation': 'Department of Psychology, University of North Texas, 1155 Union Circle #311280, Denton, TX, 76203, United States. Electronic address: CaitlynCarey@my.unt.edu.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101617']
2987,32981091,Effects of the Helping Mothers Survive Bleeding after Birth training on near miss morbidity and mortality in Uganda: A cluster-randomized trial.,"OBJECTIVE


To assess the effect of Helping Mothers Survive Bleeding after Birth training on postpartum hemorrhage (PPH) near miss and case fatality rates in Uganda.
METHODS


Training was evaluated using a cluster-randomized design between June 2016 and September 2017 in 18 typical rural districts (clusters) in Eastern and Central Uganda of which nine districts were randomly assigned to the intervention. The main outcome was PPH near miss defined using the World Health Organization's disease and management-based approach. Interrupted time series analysis was performed to estimate the difference in the change of outcomes.
RESULTS


Outcomes of 58 000 and 95 455 deliveries during the 6-month baseline and 10-month endline periods, respectively, were included. A reduction of PPH near misses was observed in the intervention compared to the comparison districts (difference-in-difference of slopes 4.19, 95% CI, -7.64 to -0.74); P<0.05). There was an increase in overall reported near miss cases (difference-in-difference 1.24, 95% CI, 0.37-2.10; P<0.001) and an increase in PPH case fatality rate (difference-in-difference 2.13, 95% CI, 0.14-4.12; P<0.05).
CONCLUSION


This pragmatic cluster-randomized trial conducted in typical rural districts of Uganda indicated a reduction of severe PPH cases while case fatality did not improve, suggesting that this basic training needs to be complemented by additional measures for sustained mortality reduction.
TRIAL REGISTRATION


PACTR201604001582128.",2020,"A reduction of PPH near misses was observed in the intervention compared to the comparison districts (difference-in-difference of slopes 4.19, 95% CI, -7.64 to -0.74); P<0.05).","['Uganda', 'typical rural districts of Uganda', 'Training was evaluated using a cluster-randomized design between June 2016 and September 2017 in 18 typical rural districts (clusters) in Eastern and Central Uganda of which nine districts']",['Birth training'],"['PPH near misses', 'PPH case fatality rate', ""PPH near miss defined using the World Health Organization's disease and management-based approach"", 'postpartum hemorrhage (PPH) near-miss and case fatality rates']","[{'cui': 'C0041573', 'cui_str': 'Uganda'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C0282250', 'cui_str': 'Case fatality rate'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0032797', 'cui_str': 'Postpartum hemorrhage'}]",9.0,0.195018,"A reduction of PPH near misses was observed in the intervention compared to the comparison districts (difference-in-difference of slopes 4.19, 95% CI, -7.64 to -0.74); P<0.05).","[{'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Hanson', 'Affiliation': 'Department of Global Public Health Sciences, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Atuhairwe', 'Affiliation': 'Directorate of Obstetrics and Gynecology, Mulago National Referral Hospital, Kampala, Uganda.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Lucy Atim', 'Affiliation': 'Mbale Regional Referral Hospital, Mbale, Uganda.'}, {'ForeName': 'Gaetano', 'Initials': 'G', 'LastName': 'Marrone', 'Affiliation': 'Department of Global Public Health Sciences, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Morris', 'Affiliation': 'FIGO (International Federation of Gynecology and Obstetrics), London, UK.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Kaharuza', 'Affiliation': 'Association of Obstetricians and Gynaecologists of Uganda, Kampala, Uganda.'}]",International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics,['10.1002/ijgo.13395']
2988,32981468,Concurrent complex and endurance training for recreational marathon runners: Effects on neuromuscular and running performance.,"Marathon performance is influenced by factors such as aerobic capacity and those related to neuromuscular function. Complex training (CPX) is a multicomponent training method, wherein heavy strength and plyometric exercises alternate within a single session and is an effective method to improve neuromuscular adaptations. This study compared the effects of CPX, heavy strength training (HST) and endurance-strength (EST) combined with running endurance training on neuromuscular adaptations and running performance in 38 recreational marathoners (age:31.4 ± 3.8 years, VO 2max :57.6 ± 6.8 ml·kg -1 ·min -1 ). Athletes were allocated in 3 groups: CPX, HST and EST and were tested for one maximum repetition strength (1RM), squat jump and countermovement jumps (SJ, CMJ), leg press (LP) concentric and eccentric strength, running economy (RE) and velocity at VO 2max  (vVO 2max ) before and after the 6-week intervention. CPX and HST were performed 2 times per week in conjunction with the running endurance training. RE and vVO 2max  improved in CPX and HST groups ( p  <   0.01, RE: -5% to -6.4%, vVO2max: 5.7% and 4.2%, respectively) with no change in EST. Similarly, all neuromuscular performance indicators improved in CPX and HST ( p  <   0.0167, 1RM strength:19.7% to 25.1%, SJ and CMJ: 5.3% to 11.6%, LP concentric and eccentric strength: 5.5% to 18.0%). In summary, 6-week of concurrent CPX or HST and endurance training resulted in similar improvement in maximum strength, RE, and vVO 2max . Importantly, both CPX and HST training resulted in greater improvements in eccentric strength and RE compared to EST that performed concurrent endurance-strength and endurance training.",2020,Both complex and heavy strength training resulted in greater improvements in eccentric strength and RE compared to the concurrent low-intensity endurance-strength and endurance training.,"['38 recreational marathoners (age:31.4 ± 3.8 years, VO 2max :57.6 ± 6.8 ml·kg -1 ·min -1 ', 'Recreational Marathon Runners']","['CPX, HST and EST', 'CPX, heavy strength training (HST) and endurance-strength (EST) combined with running endurance training', 'concurrent complex or heavy strength and endurance training', '▿ Complex training', 'complex and heavy strength training', 'Concurrent Complex and Endurance Training', 'vVO2max', 'Complex training (CPX', 'CPX and HST training', 'CPX or HST and endurance training', 'CPX and HST']","['RE and vVO 2max', 'eccentric strength and eccentric utilization ratio', 'eccentric strength and RE', 'maximum strength, RE, and vVO 2max ', 'maximum strength, jumping performance, RE, and vVO 2max', 'maximum repetition strength (1RM), squat jump and countermovement jumps (SJ, CMJ), leg press (LP) concentric and eccentric strength, running economy (RE) and velocity at VO 2max  (vVO 2max ', 'neuromuscular adaptations and running performance', 'neuromuscular performance indicators improved in CPX and HST']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1301862', 'cui_str': 'Min 1'}, {'cui': 'C0168374', 'cui_str': 'Marathon composite resin'}]","[{'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}]","[{'cui': 'C0439740', 'cui_str': 'Eccentric'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0439744', 'cui_str': 'Concentric'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]",38.0,0.0208118,Both complex and heavy strength training resulted in greater improvements in eccentric strength and RE compared to the concurrent low-intensity endurance-strength and endurance training.,"[{'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': ""School of Physical Education and Sport Training, Shanghai University of Sport, Shanghai, People's Republic of China.""}, {'ForeName': 'George P', 'Initials': 'GP', 'LastName': 'Nassis', 'Affiliation': ""School of Physical Education and Sport Training, Shanghai University of Sport, Shanghai, People's Republic of China.""}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': ""School of Kinesiology, Shanghai University of Sport, Shanghai, People's Republic of China.""}, {'ForeName': 'Guangqiang', 'Initials': 'G', 'LastName': 'Han', 'Affiliation': ""School of Physical Education and Sport Training, Shanghai University of Sport, Shanghai, People's Republic of China.""}, {'ForeName': 'Xiaohui', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ""School of Physical Education and Sport Training, Shanghai University of Sport, Shanghai, People's Republic of China.""}, {'ForeName': 'Binghong', 'Initials': 'B', 'LastName': 'Gao', 'Affiliation': ""School of Physical Education and Sport Training, Shanghai University of Sport, Shanghai, People's Republic of China.""}, {'ForeName': 'Haiyong', 'Initials': 'H', 'LastName': 'Ding', 'Affiliation': ""School of Physical Education and Sport Training, Shanghai University of Sport, Shanghai, People's Republic of China.""}]",European journal of sport science,['10.1080/17461391.2020.1829080']
2989,32991046,Differential effects of L- and D-phenylalanine on pancreatic and gastrointestinal hormone release in humans: A randomized crossover study.,"AIM


To investigate the effects of L-phenylalanine on gastroenteropancreatic hormone release, glucose levels, subjective appetite and energy intake in humans, and to determine whether these effects were stereoisomer-specific by comparing them with D-phenylalanine.
MATERIALS AND METHODS


A dose-finding, non-randomized, unblinded, crossover study was conducted during October-December 2017 at the NIHR Imperial Clinical Research Facility in five participants, in which the tolerability of escalating doses of oral L-phenylalanine was assessed (0, 3, 6 and 10 g). Also, an acute, randomized, double-blind, placebo-controlled crossover study was conducted during January-May 2018 at the NIHR Imperial Clinical Research Facility in 11 participants, in which the effects of oral 10 g L-phenylalanine relative to D-phenylalanine and placebo on gastroenteropancreatic hormone (insulin, glucagon, glucose-dependent insulinotropic polypeptide [GIP], peptide tyrosine tyrosine [PYY], glucagon-like peptide-1) and glucose concentrations, visual analogue scales for subjective appetite and energy intake at an ad libitum meal served 70 minutes postingestion, were investigated.
RESULTS


L-phenylalanine was well-tolerated and increased insulin and glucagon concentrations prior to meal ingestion at several time points relative to placebo and D-phenylalanine (P < .05). L-phenylalanine also increased GIP concentrations relative to D-phenylalanine (P = .0420) and placebo (P = .0249) 70 minutes following ingestion. L-phenylalanine reduced postprandial glucose area under the curve (AUC) 70-150mins  relative to placebo (P = .0317) but did not affect subjective appetite or energy intake (P > .05). D-phenylalanine increased postprandial PYY AUC 70-150mins  concentrations relative to placebo (P = .0002).
CONCLUSIONS


Ingestion of L-phenylalanine, but not D-phenylalanine, increases insulin, glucagon and GIP concentrations without appearing to have a marked effect on appetite.",2020,L-phenylalanine also increased GIP concentrations relative to D-phenylalanine (P=0.0420) and placebo (P=0.0249) 70 minutes following ingestion.,"['humans', 'October 2017 to December 2017 at the NIHR Imperial Clinical Research Facility in 5 participants', 'from January to May 2018 at the NIHR Imperial Clinical Research Facility in 11 participants']","['oral L-phenylalanine', 'L- and D-phenylalanine', 'placebo', 'oral 10g L-phenylalanine relative to D-phenylalanine and placebo', 'L-phenylalanine']","['tolerated and increased insulin and glucagon concentrations', 'subjective appetite or energy intake', 'pancreatic and gastrointestinal hormone release', 'gastroenteropancreatic hormone (insulin, glucagon, GIP, PYY, GLP-1) and glucose concentrations, visual analogue scales for subjective appetite and energy intake', 'insulin, glucagon and GIP concentrations', 'postprandial glucose', 'GIP concentrations']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0031453', 'cui_str': 'Phenylalanine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1318182', 'cui_str': '10G'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}]","[{'cui': 'C0020459', 'cui_str': 'Hyperinsulinism'}, {'cui': 'C0017687', 'cui_str': 'Glucagon'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0030274', 'cui_str': 'Pancreatic structure'}, {'cui': 'C0017182', 'cui_str': 'Gastrointestinal hormone'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0017132', 'cui_str': 'Gastric inhibitory polypeptide'}, {'cui': 'C0070358', 'cui_str': 'Peptide YY'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0427743', 'cui_str': 'Glucose concentration, test strip measurement'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}]",,0.273665,L-phenylalanine also increased GIP concentrations relative to D-phenylalanine (P=0.0420) and placebo (P=0.0249) 70 minutes following ingestion.,"[{'ForeName': 'Anjali', 'Initials': 'A', 'LastName': 'Amin', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Department of Metabolism, Digestion and Reproduction, Faculty of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Frampton', 'Affiliation': 'Section for Nutrition Research, Department of Metabolism, Digestion and Reproduction, Faculty of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Zhigang', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Section for Nutrition Research, Department of Metabolism, Digestion and Reproduction, Faculty of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Georgia', 'Initials': 'G', 'LastName': 'Franco-Becker', 'Affiliation': 'Section for Nutrition Research, Department of Metabolism, Digestion and Reproduction, Faculty of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Norton', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Department of Metabolism, Digestion and Reproduction, Faculty of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Aos', 'Initials': 'A', 'LastName': 'Alaa', 'Affiliation': 'Section for Nutrition Research, Department of Metabolism, Digestion and Reproduction, Faculty of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Jia V', 'Initials': 'JV', 'LastName': 'Li', 'Affiliation': 'Section for Nutrition Research, Department of Metabolism, Digestion and Reproduction, Faculty of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Kevin G', 'Initials': 'KG', 'LastName': 'Murphy', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Department of Metabolism, Digestion and Reproduction, Faculty of Medicine, Imperial College London, London, UK.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14204']
2990,32987199,Pharmacodynamics of asfotase alfa in adults with pediatric-onset hypophosphatasia.,"BACKGROUND


Hypophosphatasia (HPP) is the rare, inherited, metabolic bone disease characterized by low activity of the tissue-nonspecific isoenzyme of alkaline phosphatase (TNSALP) leading to excess extracellular inorganic pyrophosphate (PPi) and pyridoxal 5'-phosphate (PLP). Asfotase alfa is the human recombinant enzyme-replacement therapy that replaces deficient TNSALP. However, there is limited information concerning the appropriate dose of asfotase alfa for adult patients with pediatric-onset HPP. Thus, we evaluated the pharmacodynamics and safety/tolerability of different doses of asfotase alfa in such patients.
METHODS


This 13-week, Phase 2a, open-label study enrolled adults (aged ≥18 years) with pediatric-onset HPP. They were randomized 1:1:1 to receive a single subcutaneous dose of asfotase alfa (0.5, 2.0, or 3.0 mg/kg) at Week 1, then 3 times per week (ie, 1.5, 6.0, or 9.0 mg/kg/wk) starting at Week 3 for 7 weeks. Key outcome measures included change from Baseline to before the third dose during Week 9 (trough) in plasma PPi (primary outcome measure) and PLP (secondary outcome measure).
RESULTS


Twenty-seven adults received asfotase alfa 0.5 (n = 8), 2.0 (n = 10), and 3.0 (n = 9) mg/kg; all completed the study. Median (range) age was 45 (18-77) years; most patients were white (96%) and female (59%). Median plasma PPi and PLP concentrations decreased from Baseline to Week 9 in all 3 cohorts. Differences in least squares mean (LSM) changes in PPi were significant with 2.0 mg/kg (p = 0.0008) and 3.0 mg/kg (p < 0.0001) vs. 0.5 mg/kg. Differences in LSM changes in PLP were also significant for 2.0 mg/kg (p = 0.0239) and 3.0 mg/kg (p = 0.0128) vs. 0.5 mg/kg. Injection site reactions were the most frequent treatment-emergent adverse event (78%), showing increasing frequency with increasing dose.
CONCLUSIONS


Adults with pediatric-onset HPP receiving asfotase alfa at 6.0 mg/kg/wk (the recommended dose) or 9.0 mg/kg/wk had greater reductions in circulating PPi and PLP concentrations compared with a lower dose of 1.5 mg/kg/wk.
TRIAL REGISTRATION


Clinicaltrials.gov identifier NCT02797821.",2020,"Injection site reactions were the most frequent treatment-emergent adverse event (78%), showing increasing frequency with increasing dose.
","['Adults with pediatric-onset HPP receiving', 'Twenty-seven adults received asfotase alfa 0.5 (n=8), 2.0 (n=10), and 3.0 (n=9) mg/kg; all completed the study', 'adult patients with pediatric-onset HPP', 'Adults With Pediatric-Onset Hypophosphatasia', 'Median (range) age was 45 (18-77) years; most patients were white (96%) and female (59', '13-week, Phase 2a, open-label study enrolled adults (aged ≥18 years) with pediatric-onset HPP']","['single subcutaneous dose of asfotase alfa', 'asfotase alfa', 'Asfotase Alfa']","['Least squares mean (LSM) changes in PPi', 'LSM differences in PLP changes', 'change from Baseline to before the third dose during Week 9 (trough) in plasma PPi (primary outcome measure) and PLP (secondary outcome measure', 'circulating PPi and PLP concentrations', 'Median plasma PPi and PLP concentrations', 'pharmacodynamics and safety/tolerability']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0020630', 'cui_str': 'Hypophosphatasia'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C3490795', 'cui_str': 'asfotase alfa'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0175566', 'cui_str': 'Open'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C3490795', 'cui_str': 'asfotase alfa'}]","[{'cui': 'C0023189', 'cui_str': 'Analysis, Least-Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0034266', 'cui_str': 'pyridoxal phosphate'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.169277,"Injection site reactions were the most frequent treatment-emergent adverse event (78%), showing increasing frequency with increasing dose.
","[{'ForeName': 'Lothar', 'Initials': 'L', 'LastName': 'Seefried', 'Affiliation': 'Orthopedic Department, University of Würzburg, Würzburg, Bavaria, Germany. Electronic address: l-seefried.klh@uni-wuerzburg.de.'}, {'ForeName': 'Priya S', 'Initials': 'PS', 'LastName': 'Kishnani', 'Affiliation': 'Department of Pediatrics, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Moseley', 'Affiliation': 'Alexion Pharmaceuticals, Inc., Boston, MA, USA.'}, {'ForeName': 'Andrew E', 'Initials': 'AE', 'LastName': 'Denker', 'Affiliation': 'Alexion Pharmaceuticals, Inc., Boston, MA, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Watsky', 'Affiliation': 'Alexion Pharmaceuticals, Inc., Boston, MA, USA.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Whyte', 'Affiliation': 'Center for Metabolic Bone Disease and Molecular Research, Shriners Hospitals for Children-St. Louis, St. Louis, MO, USA; Division of Bone and Mineral Diseases, Department of Internal Medicine, Washington University School of Medicine at Barnes-Jewish Hospital, St Louis, MO, USA.'}, {'ForeName': 'Kathryn M', 'Initials': 'KM', 'LastName': 'Dahir', 'Affiliation': 'Program for Metabolic Bone Disorders at Vanderbilt, Division of Diabetes and Endocrinology, Vanderbilt University Medical Center, Nashville, TN, USA.'}]",Bone,['10.1016/j.bone.2020.115664']
2991,32987227,Family Integrated Care (FICare): Positive impact on behavioural outcomes at 18 months.,"BACKGROUND


Children born very preterm demonstrate behavioural challenges due to clinical factors, exposure to the high stress environment of intensive care, and separation from parents during neonatal hospitalization at a critical stage in development. Family Integrated Care (FICare) significantly reduced parent stress and anxiety, and improved neonatal outcomes.
AIMS


To examine the impact of FICare on behavioural outcomes at 18-21 months corrected age (CA), and assess possible mediation through parenting or infant growth.
STUDY DESIGN AND METHODS


A prospective cohort study enrolling infants under 33 weeks gestation and parents from the FICare cluster randomized controlled trial. Primary outcome was behaviour assessed by the Infant Toddler Social Emotional Assessment (ITSEA). Parent child variables were measured with the Nursing Child Assessment Satellite Training (NCAST), Parenting Stress Index (PSI) and infant growth.
RESULTS


Subjects included 123 FICare infants and 62 standard care controls evaluated at 18-21 months CA. FICare infants demonstrated lower ITSEA Dysregulation, indicating better self-regulation skills, compared with the control group (T-score 41.7 vs 46.6, p < 0.01). At 12 months CA, the NCAST Child subtotal score was higher and the PSI-Child Domain score was lower in FICare infants than non-FICare infants. The PSI-Child domain was identified as a possible mediator of FICare on child behaviour (mediation effect 1.28, -2.96-0.02, p = 0.044).
CONCLUSION


FICare in the NICU has a sustained effect on child behaviour, improving self-regulation at 18-21 months CA.",2020,"FICare infants demonstrated lower ITSEA Dysregulation, indicating better self-regulation skills, compared with the control group (T-score 41.7 vs 46.6, p < 0.01).","['A prospective cohort study enrolling infants under 33\xa0weeks gestation and parents from the FICare cluster randomized controlled trial', 'Children born very preterm', 'Subjects included 123 FICare infants and 62 standard care controls evaluated at 18-21\xa0months CA']","['FICare', 'Family Integrated Care (FICare']","['parent stress and anxiety, and improved neonatal outcomes', 'Nursing Child Assessment Satellite Training (NCAST), Parenting Stress Index (PSI) and infant growth', 'behavioural outcomes', 'PSI-Child Domain score', 'lower ITSEA Dysregulation', 'NCAST Child subtotal score', 'behaviour assessed by the Infant Toddler Social Emotional Assessment (ITSEA', 'self-regulation skills', 'child behaviour, improving self-regulation']","[{'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0021272', 'cui_str': 'Infant care'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0036238', 'cui_str': 'Associated Viruses'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0682053', 'cui_str': 'Toddler'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}]",123.0,0.0623273,"FICare infants demonstrated lower ITSEA Dysregulation, indicating better self-regulation skills, compared with the control group (T-score 41.7 vs 46.6, p < 0.01).","[{'ForeName': 'Paige Terrien', 'Initials': 'PT', 'LastName': 'Church', 'Affiliation': ""Sunnybrook Health Sciences Centre, Department of Newborn and Developmental Paediatrics, 2075 Bayview Avenue, M4-234, Toronto, ON M4N 3M5, Canada; University of Toronto, Department of Paediatrics, 27 King's College Cir, Toronto, ON M5S 3H7, Canada.""}, {'ForeName': 'Ruth E', 'Initials': 'RE', 'LastName': 'Grunau', 'Affiliation': ""University of British Columbia, Department of Pediatrics and BC Children's Research Institute, 4500 Oak Street, Vancouver, BC V6H 3N1, Canada; BC Women's Hospital, 4500 Oak St, Vancouver, BC V6H 3N4, Canada.""}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Mirea', 'Affiliation': 'Maternal-Infant Care Research Centre, Mount Sinai Hospital, 700 University Avenue, Suite 8-500, Toronto, ON M5G 1X6, Canada.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Petrie', 'Affiliation': ""BC Women's Hospital, 4500 Oak St, Vancouver, BC V6H 3N4, Canada.""}, {'ForeName': 'Amuchou Singh', 'Initials': 'AS', 'LastName': 'Soraisham', 'Affiliation': ""Alberta Children's Hospital Research Institute, Foothills Medical Centre, University of Calgary, 1403, 29th Street NW, Calgary, AB T2N 2T9, Canada.""}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Synnes', 'Affiliation': ""University of British Columbia, Department of Pediatrics and BC Children's Research Institute, 4500 Oak Street, Vancouver, BC V6H 3N1, Canada; BC Women's Hospital, 4500 Oak St, Vancouver, BC V6H 3N4, Canada.""}, {'ForeName': 'Xiang Y', 'Initials': 'XY', 'LastName': 'Ye', 'Affiliation': 'Maternal-Infant Care Research Centre, Mount Sinai Hospital, 700 University Avenue, Suite 8-500, Toronto, ON M5G 1X6, Canada.'}, {'ForeName': 'Karel', 'Initials': 'K', 'LastName': ""O'Brien"", 'Affiliation': ""University of Toronto, Department of Paediatrics, 27 King's College Cir, Toronto, ON M5S 3H7, Canada; Maternal-Infant Care Research Centre, Mount Sinai Hospital, 700 University Avenue, Suite 8-500, Toronto, ON M5G 1X6, Canada; Mount Sinai Hospital, Department of Paediatrics, 600 University Avenue, Toronto, ON M5G 1X5, Canada. Electronic address: karel.obrien@sinaihealth.ca.""}]",Early human development,['10.1016/j.earlhumdev.2020.105196']
2992,32987282,Fundamental frequency during cognitive preparation and its impact on therapy outcome for panic disorder with Agoraphobia.,"BACKGROUND


Cognitive preparation plays a crucial role in CBT with exposure for panic disorder and agoraphobia. High emotional arousal while developing the exposure rationale might impair patients' cognitive capacities for processing information about treatment and impede therapeutic outcome.
OBJECTIVE


This study investigates whether patients' vocally encoded emotional arousal, assessed by fundamental frequency (f 0 ), during rationale development is associated with premature treatment dropout, insight into the rationale, and symptom reduction.
METHODS


Patients' (N = 197, mean age 36.1 years, 79.2% female) f 0  during rationale development was measured based on treatment videos from a randomized controlled trial of CBT for panic disorder and agoraphobia. Insight was rater assessed. Symptom severity was self- and rater assessed at the beginning and end of therapy.
RESULTS


Higher f 0  mean during rationale development was associated with lower probability of insight and less reduction in avoidance behavior. f 0  was not associated with dropout. Insight was associated with lower probability of dropout and partially mediated the association between f 0  and avoidance reduction.
DISCUSSION


This study highlights the importance of emotional arousal during cognitive preparation for exposure. Therapists should ensure that patients are not too highly aroused while learning about the exposure rationale as an important step in treatment.",2020,f 0  during rationale development was measured based on treatment videos from a randomized controlled trial of CBT for panic disorder and agoraphobia.,"['panic disorder with Agoraphobia', ""Patients' (N\xa0=\xa0197, mean age 36.1 years, 79.2% female""]",['CBT'],['avoidance behavior'],"[{'cui': 'C0236800', 'cui_str': 'Panic disorder with agoraphobia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0178494', 'cui_str': 'Avoidance behavior'}]",,0.0479158,f 0  during rationale development was measured based on treatment videos from a randomized controlled trial of CBT for panic disorder and agoraphobia.,"[{'ForeName': 'Gesine', 'Initials': 'G', 'LastName': 'Wieder', 'Affiliation': 'Institute for Clinical Psychology and Psychotherapy, Dresden University of Technology, Chemnitzer Strasse 46, 01187, Dresden, Germany; Department of Differential and Personality Psychology, Dresden University of Technology, Zellescher Weg 17, 01069, Dresden, Germany. Electronic address: gesine.wieder@tu-dresden.de.'}, {'ForeName': 'Melanie S', 'Initials': 'MS', 'LastName': 'Fischer', 'Affiliation': 'Institute of Medical Psychology, Heidelberg University Hospital, Bergheimer Strasse 20, 69115, Heidelberg, Germany; Faculty of Behavioural and Cultural Studies, Ruprecht-Karls University Heidelberg, Voßstrasse 2, 69115, Heidelberg, Germany.'}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Einsle', 'Affiliation': 'Institute for Clinical Psychology and Psychotherapy, Dresden University of Technology, Chemnitzer Strasse 46, 01187, Dresden, Germany.'}, {'ForeName': 'Donald H', 'Initials': 'DH', 'LastName': 'Baucom', 'Affiliation': 'Department of Psychology and Neuroscience, Davie Hall, CB #3270, University of North Carolina at Chapel Hill, Chapel Hill, NC, 27599-3270, USA.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Hahlweg', 'Affiliation': 'Institute for Psychology, Department of Clinical Psychology, Psychotherapy and Diagnostics, Technische Universitaet Braunschweig, Mail address: Schwäbische Str. 7, 10781, Berlin, Germany.'}, {'ForeName': 'Hans-Ulrich', 'Initials': 'HU', 'LastName': 'Wittchen', 'Affiliation': 'Institute for Clinical Psychology and Psychotherapy, Dresden University of Technology, Chemnitzer Strasse 46, 01187, Dresden, Germany; Department of Psychiatry and Psychotherapy, Ludwig-Maximilians-Universitaet, Nussbaumstraße 7, 80336, Munich, Germany.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Weusthoff', 'Affiliation': 'Institute for Psychology, Department of Clinical Psychology, Psychotherapy and Diagnostics, Technische Universitaet Braunschweig, Mail address: Schwäbische Str. 7, 10781, Berlin, Germany; Private Psychotherapeutic Practice, Everswinkeler Strasse 4, 48351, Alverskirchen, Germany.'}]",Behaviour research and therapy,['10.1016/j.brat.2020.103728']
2993,32987332,Lamotrigine for reducing ketamine-induced psychologic disturbances: A pilot randomized and blinded trial.,,2020,,['induced psychologic disturbances'],"['ketamine', 'Lamotrigine']",[],"[{'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0064636', 'cui_str': 'lamotrigine'}]",[],,0.14572,,"[{'ForeName': 'Kamal', 'Initials': 'K', 'LastName': 'Maheshwari', 'Affiliation': 'Department of General Anesthesiology, Cleveland Clinic, Cleveland, OH, United States of America; Department of Outcomes Research, Cleveland Clinic, Cleveland, OH, United States of America. Electronic address: MAHESHK@ccf.org.'}, {'ForeName': 'Omer', 'Initials': 'O', 'LastName': 'Bakal', 'Affiliation': 'Department of Outcomes Research, Cleveland Clinic, Cleveland, OH, United States of America.'}, {'ForeName': 'Pu', 'Initials': 'P', 'LastName': 'Xuan', 'Affiliation': 'Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, OH, United States of America; Department of Outcomes Research, Cleveland Clinic, Cleveland, OH, United States of America.'}, {'ForeName': 'Alparslan', 'Initials': 'A', 'LastName': 'Turan', 'Affiliation': 'Department of General Anesthesiology, Cleveland Clinic, Cleveland, OH, United States of America; Department of Outcomes Research, Cleveland Clinic, Cleveland, OH, United States of America.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Fang', 'Affiliation': 'Department of Outcomes Research, Cleveland Clinic, Cleveland, OH, United States of America.'}, {'ForeName': 'Wael Ali Sakr', 'Initials': 'WAS', 'LastName': 'Esa', 'Affiliation': 'Department of General Anesthesiology, Cleveland Clinic, Cleveland, OH, United States of America.'}, {'ForeName': 'Daniel I', 'Initials': 'DI', 'LastName': 'Sessler', 'Affiliation': 'Department of Outcomes Research, Cleveland Clinic, Cleveland, OH, United States of America.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Anand', 'Affiliation': 'Department of Psychiatry, Cleveland Clinic, Cleveland, OH, United States of America.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.110074']
2994,32991303,Coping Skills Mobile App to Support the Emotional Well-Being of Young People During the COVID-19 Pandemic: Protocol for a Mixed Methods Study.,"BACKGROUND


The COVID-19 pandemic is likely to increase anxiety and distress in young people worldwide. It is important to prioritize mental health during crisis events to mitigate the negative and often long-term effects of the crises on young people, families, and society. Mental health and well-being apps represent a scalable approach for improving psychological outcomes in young people and have potential to improve the equity of service access.
OBJECTIVE


The Whitu: 7 Ways in 7 Days well-being app was recently developed by our group to address the urgent need for innovative approaches to reach young New Zealanders who are struggling to cope with the COVID-19 pandemic. The aim of this study is twofold: to evaluate the acceptability of the prototype app and to examine the effectiveness of the refined app at improving mental and emotional well-being and reducing depression, anxiety, and stress in young people in New Zealand.
METHODS


A two-phase mixed methods study will be undertaken to achieve these aims. During the first phase, 20 young people aged 16-30 years (including those of Māori and Pacific ethnicity) will participate in a qualitative study to help refine the prototype app. During the second phase, 90 young people aged 16-30 years will participate in a randomized waitlist-controlled trial (RCT) to evaluate the efficacy of the refined Whitu app at 4 weeks and 3 months after baseline. Outcomes will be evaluated using validated web-based questionnaires at baseline, 4 weeks, and 3 months.
RESULTS


The study received ethics approval in May 2020, and recruitment for the focus groups commenced in June 2020. Recruitment for the RCT is expected to commence in October 2020. Participants for both study phases will be recruited via social media and web-based communities. Data collection for the RCT is expected to be completed by January 2021, and analyses are expected to be completed by March 2021. Linear mixed modelling will be used to determine between-group differences in psychological outcomes.
CONCLUSIONS


There is an urgent need to develop culturally appropriate, scalable mental health interventions to address the psychological consequences of the COVID-19 pandemic. In this study, we will develop and test an evidence-based well-being app that, if effective, can be made available to all young people in New Zealand and internationally.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry (ACTRN12620000516987); https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=379597.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


PRR1-10.2196/23716.",2020,"Mental health and wellbeing apps represent a scalable approach for improving psychological outcomes in young people and have the potential to improve equity of service access.
","['young people', 'New Zealand young people', '90 young people aged 16-30 years', '20 young people aged 16-30 years (including those of Māori and Pacific ethnicity', 'young people in New Zealand and internationally', 'Methods', 'Participants for both study phases will be recruited via social media and online communities', 'Young People']",[],"['mental/emotional wellbeing and reducing depression, anxiety and stress', 'anxiety and distress']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0009462', 'cui_str': 'Community'}]",[],"[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0231303', 'cui_str': 'Distress'}]",,0.0963207,"Mental health and wellbeing apps represent a scalable approach for improving psychological outcomes in young people and have the potential to improve equity of service access.
","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Serlachius', 'Affiliation': 'Department of Psychological Medicine, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Kiralee', 'Initials': 'K', 'LastName': 'Schache', 'Affiliation': 'Department of Psychological Medicine, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Boggiss', 'Affiliation': 'Department of Psychological Medicine, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Lim', 'Affiliation': 'Department of Psychological Medicine, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Wallace-Boyd', 'Affiliation': 'Department of Psychological Medicine, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Brenton-Peters', 'Affiliation': 'Department of Psychological Medicine, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Buttenshaw', 'Affiliation': 'Department of Psychological Medicine, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Chadd', 'Affiliation': 'Department of Psychological Medicine, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Alana', 'Initials': 'A', 'LastName': 'Cavadino', 'Affiliation': 'Epidemiology and Biostatistics, School of Population Health, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Cao', 'Affiliation': 'Tamaki Health, Auckland, New Zealand.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Morunga', 'Affiliation': 'Department of Psychological Medicine, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Hiran', 'Initials': 'H', 'LastName': 'Thabrew', 'Affiliation': 'Department of Psychological Medicine, University of Auckland, Auckland, New Zealand.'}]",JMIR research protocols,['10.2196/23716']
2995,32991946,The feasibility of a personality targeted intervention for addictive overeating: FoodFix.,"Recent reviews have identified potential treatment targets for addictive overeating. These include: motivational interviewing, development of specific coping strategies for emotional regulation and the use of harm minimisation strategies based on interventions for substance use disorders. However, there is very little experiential evidence. The aim of this study was to determine the feasibility of a personality-targeted motivational interviewing intervention in adults above the healthy-weight range with symptoms of addictive eating, to reduce symptoms of addictive overeating and improve dietary profiles. Individuals with overweight and obesity (BMI >25 kg/m 2 ) with addictive eating as defined by the modified Yale Food Addiction Scale (mYFAS) were recruited to a three-session intervention held over 3 months. Sessions were conducted by telehealth and facilitated by dietitians. Fifty-two individuals were randomised to either intervention or control (mean age 43.6 ± 12.2yrs, mean BMI 36.7 ± 6.8 kg/m 2 , 96% female). At three month follow up, there were significant reductions from baseline (BL) for both groups in total YFAS 2.0 symptoms, however, these changes were not significantly different between groups (intervention BL 8.0 ± 2.7; 3-months 6.5 ± 3.8, control BL 8.1 ± 2.5; 3-months 6.9 ± 3.9, p > 0.05). At 3 months the intervention group significantly reduced their energy from non-core foods compared with control (intervention BL 48% energy/day; 3-months 38%, control BL 41% energy/day; 3-months 38%, p < 0.01). The FoodFix intervention provides insight to the development of future management interventions for addictive eating.",2020,"At 3 months the intervention group significantly reduced their energy from non-core foods compared with control (intervention BL 48% energy/day; 3-months 38%, control BL 41% energy/day; 3-months 38%, p<0.01).","['Individuals with overweight and obesity (BMI >25kg/m 2 ) with addictive eating as defined by the modified Yale Food Addiction Scale (mYFAS', 'Fifty-two individuals were randomised to either intervention or control (mean age 43.6 ±12.2yrs, mean BMI 36.7±6.8kg/m 2 , 96% female', 'adults above the healthy-weight range with symptoms of addictive eating']","['personality-targeted motivational interviewing intervention', 'FoodFix intervention']",[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4505163', 'cui_str': 'Food Addiction'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C4319570', 'cui_str': '52'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0003944', 'cui_str': 'As If Personality'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],52.0,0.0215587,"At 3 months the intervention group significantly reduced their energy from non-core foods compared with control (intervention BL 48% energy/day; 3-months 38%, control BL 41% energy/day; 3-months 38%, p<0.01).","[{'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Burrows', 'Affiliation': 'School of Health Sciences, Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, Callaghan, 2308, NSW, Australia. Electronic address: Tracy.Burrows@newcastle.edu.au.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Collins', 'Affiliation': 'School of Health Sciences, Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, Callaghan, 2308, NSW, Australia. Electronic address: rebecca.collins10@newcastle.edu.au.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Rollo', 'Affiliation': 'School of Health Sciences, Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, Callaghan, 2308, NSW, Australia. Electronic address: megan.rollo@newcastle.edu.au.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Leary', 'Affiliation': 'School of Health Sciences, Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, Callaghan, 2308, NSW, Australia. Electronic address: mark.leary@uon.edu.au.'}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Hides', 'Affiliation': 'School of Psychology, University of Queensland, Brisbane, NSW, Australia. Electronic address: l.hides@uq.edu.au.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Davis', 'Affiliation': 'School of Kinesiology and Health Sciences, York University, Toronto, Canada. Electronic address: cdavis@yorku.ca.'}]",Appetite,['10.1016/j.appet.2020.104974']
2996,32992020,Pain relief for osteoarthritis through combined treatment (PROACT): Protocol for a randomized controlled trial of mindfulness meditation combined with transcranial direct current stimulation in non-Hispanic black and white adults with knee osteoarthritis.,"Knee osteoarthritis (OA) is a leading cause of late life pain and disability, and non-Hispanic black (NHB) adults experience greater OA-related pain and disability than non-Hispanic whites (NHWs). Recent evidence implicates psychosocial stress, cognitive-attentional processes, and altered central pain processing as contributors to greater OA-related pain and disability among NHBs. To address these ethnic/race disparities, this clinical trial will test whether a mindfulness intervention (Breathing and Attention Training, BAT) combined with transcranial direct current stimulation (tDCS) will enhance pain modulatory balance and pain-related brain function, reduce clinical pain, and attenuate ethnic differences therein, among NHBs and NHWs with knee OA. Participants will complete assessments of clinical pain, function, psychosocial measures, and quantitative sensory testing (QST), including mechanical temporal summation and conditioned pain modulation. Neuroimaging will be performed to examine pain-related brain structure and function. Then, participants will be randomized to one of four groups created by crossing two BAT conditions (Real vs. Sham) with two tDCS conditions (Real vs. Sham). Participants will then undergo five treatment sessions during which the assigned BAT and tDCS interventions will be delivered concurrently for 20 min over one week. After the fifth intervention session, participants will undergo assessments of clinical pain and function, QST and neuroimaging identical to the pretreatment measures, and monthly follow-up assessments of pain will be conducted for three months. This will be the first study to determine whether mindfulness and tDCS treatments will show additive or synergistic effects when combined, and whether treatment effects differ across ethnic/race groups.",2020,"After the fifth intervention session, participants will undergo assessments of clinical pain and function, QST and neuroimaging identical to the pretreatment measures, and monthly follow-up assessments of pain will be conducted for three months.",['non-Hispanic black and white adults with knee osteoarthritis'],"['mindfulness intervention (Breathing and Attention Training, BAT) combined with transcranial direct current stimulation (tDCS', 'mindfulness meditation combined with transcranial direct current stimulation']","['Knee osteoarthritis (OA', 'Pain relief', 'clinical pain, function, psychosocial measures, and quantitative sensory testing (QST), including mechanical temporal summation and conditioned pain modulation']","[{'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0556509', 'cui_str': 'Attention training'}, {'cui': 'C0006298', 'cui_str': 'Brown fat'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0430838', 'cui_str': 'Quantitative sensory test'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0234110', 'cui_str': 'Temporal summation'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}]",,0.077445,"After the fifth intervention session, participants will undergo assessments of clinical pain and function, QST and neuroimaging identical to the pretreatment measures, and monthly follow-up assessments of pain will be conducted for three months.","[{'ForeName': 'Roger B', 'Initials': 'RB', 'LastName': 'Fillingim', 'Affiliation': 'Department of Community Dentistry & Behavioral Science, University of Florida, Gainesville, FL, USA; Pain Research & Intervention Center of Excellence, University of Florida, Gainesville, FL, USA. Electronic address: rfilling@ufl.edu.'}, {'ForeName': 'Adam J', 'Initials': 'AJ', 'LastName': 'Woods', 'Affiliation': 'Department of Clinical and Health Psychology, Center for Cognitive Aging and Memory, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Hyochol', 'Initials': 'H', 'LastName': 'Ahn', 'Affiliation': 'Department of Nursing Systems, University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Samuel S', 'Initials': 'SS', 'LastName': 'Wu', 'Affiliation': 'Department of Biostatistics, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'David T', 'Initials': 'DT', 'LastName': 'Redden', 'Affiliation': 'Department of Biostatistics, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Song', 'Initials': 'S', 'LastName': 'Lai', 'Affiliation': 'Department of Radiation Oncology, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Hrishikesh', 'Initials': 'H', 'LastName': 'Deshpande', 'Affiliation': 'Department of Radiology, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Deutsch', 'Affiliation': 'Department of Radiology, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Kimberly T', 'Initials': 'KT', 'LastName': 'Sibille', 'Affiliation': 'Department of Aging and Geriatric Research, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Staud', 'Affiliation': 'Department of Medicine, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Fadel', 'Initials': 'F', 'LastName': 'Zeidan', 'Affiliation': 'Department of Anesthesiology and Center for Mindfulness, University of California San Diego, San Diego, CA, USA.'}, {'ForeName': 'Burel R', 'Initials': 'BR', 'LastName': 'Goodin', 'Affiliation': 'Department of Psychology, University of Alabama at Birmingham, Birmingham, AL, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106159']
2997,33000490,Neoadjuvant Pyrotinib plus Trastuzumab and Chemotherapy for Stage I-III HER2-Positive Breast Cancer: A Phase II Clinical Trial.,"LESSONS LEARNED


This is the first trial to explore the neoadjuvant therapy of pyrotinib in HER2-positive operable and locally advanced breast cancer, in combination with epirubicin plus cyclophosphamide followed by docetaxel plus trastuzumab. Results primarily showed that pyrotinib in combination with epirubicin plus cyclophosphamide followed by docetaxel plus trastuzumab was effective and safe in HER2-positive operable and locally advanced breast cancer. A subsequent randomized controlled trial is still warranted to confirm these results.
BACKGROUND


The efficacy and safety of neoadjuvant therapy of pyrotinib, a new irreversible tyrosine kinase inhibitor (TKI), was first estimated in patients with HER2-positive breast cancer in this phase II study, in combination with trastuzumab and chemotherapy.
METHODS


Between February 19, 2019, and November 20, 2019, 20 female Chinese patients with stage I-III HER2-positive breast cancer were assigned to receive eight cycles of neoadjuvant pyrotinib (P) in combination with four cycles of epirubicin (E) and cyclophosphamide (C) followed by four cycles of docetaxel (T) and trastuzumab (H), once every 3 weeks, referred to as P + EC-TH.
RESULTS


A total of 19 patients completed the therapy and final surgery. The total pathological complete response (tpCR) rate was 73.7% (95% confidence interval [CI], 48.8-90.9), and no recurrence or metastasis occurred during the short-term follow-up period. The objective response rate (ORR) was 100% (95% CI, 82.4-100). The most common adverse events (AEs) were diarrhea and leukopenia in 18 of 20 patients (90%), but no grade 5 AEs were reported.
CONCLUSION


This study showed that in HER2-positive operable or locally advanced breast cancer, the tpCR rate of P + EC-TH neoadjuvant therapy was about twice as high as that of EC-TH neoadjuvant therapy reported in other trials, with tolerable side effects.",2020,The objective response rate (ORR) was 100% (95% CI: 82.4-100).,"['19 patients completed the therapy and final surgery', 'patients with HER2-positive breast cancer', 'HER2-Positive Breast Cancer', 'HER2-positive operable and locally advanced breast cancer', 'Stage I-III', 'Between February 19, 2019, and November 20, 2019, 20 female Chinese patients with stage I-III HER2-positive breast cancer']","['epirubicin plus cyclophosphamide', 'neoadjuvant pyrotinib (P) in combination with four cycles of epirubicin (E), cyclophosphamide (C) followed by four cycles of docetaxel (T), trastuzumab (H), once every 3\u2009weeks, referred to as P + EC-TH', 'trastuzumab and chemotherapy', 'docetaxel plus trastuzumab', 'Neoadjuvant Pyrotinib plus Trastuzumab and Chemotherapy']","['diarrhea and leukopenia', 'recurrence or metastasis', 'objective response rate (ORR', 'tpCR rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1960398', 'cui_str': 'HER2-positive carcinoma of breast'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205188', 'cui_str': 'Operable'}, {'cui': 'C3495949', 'cui_str': 'Locally advanced breast cancer'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}]","[{'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C3828434', 'cui_str': 'pyrotinib'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0585333', 'cui_str': 'Triweekly'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0023530', 'cui_str': 'Leukopenia'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]",19.0,0.0654802,The objective response rate (ORR) was 100% (95% CI: 82.4-100).,"[{'ForeName': 'Juncheng', 'Initials': 'J', 'LastName': 'Xuhong', 'Affiliation': ""Department of Breast and Thyroid Surgery, Southwest Hospital, Army Medical University, Chongqing, People's Republic of China.""}, {'ForeName': 'Xiaowei', 'Initials': 'X', 'LastName': 'Qi', 'Affiliation': ""Department of Breast and Thyroid Surgery, Southwest Hospital, Army Medical University, Chongqing, People's Republic of China.""}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Tang', 'Affiliation': ""Department of Breast and Thyroid Surgery, Southwest Hospital, Army Medical University, Chongqing, People's Republic of China.""}, {'ForeName': 'Linjun', 'Initials': 'L', 'LastName': 'Fan', 'Affiliation': ""Department of Breast and Thyroid Surgery, Southwest Hospital, Army Medical University, Chongqing, People's Republic of China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': ""Department of Breast and Thyroid Surgery, Southwest Hospital, Army Medical University, Chongqing, People's Republic of China.""}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': ""Department of Breast and Thyroid Surgery, Southwest Hospital, Army Medical University, Chongqing, People's Republic of China.""}, {'ForeName': 'Xuanni', 'Initials': 'X', 'LastName': 'Tan', 'Affiliation': ""Department of Breast and Thyroid Surgery, Southwest Hospital, Army Medical University, Chongqing, People's Republic of China.""}, {'ForeName': 'Wenting', 'Initials': 'W', 'LastName': 'Yan', 'Affiliation': ""Department of Breast and Thyroid Surgery, Southwest Hospital, Army Medical University, Chongqing, People's Republic of China.""}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Zhong', 'Affiliation': ""Department of Breast and Thyroid Surgery, Southwest Hospital, Army Medical University, Chongqing, People's Republic of China.""}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'He', 'Affiliation': ""Department of Breast and Thyroid Surgery, Southwest Hospital, Army Medical University, Chongqing, People's Republic of China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Liang', 'Affiliation': ""Department of Breast and Thyroid Surgery, Southwest Hospital, Army Medical University, Chongqing, People's Republic of China.""}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Ren', 'Affiliation': ""Department of Breast and Thyroid Surgery, Southwest Hospital, Army Medical University, Chongqing, People's Republic of China.""}, {'ForeName': 'Minghao', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': ""Department of Breast and Thyroid Surgery, Southwest Hospital, Army Medical University, Chongqing, People's Republic of China.""}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Department of Breast and Thyroid Surgery, Southwest Hospital, Army Medical University, Chongqing, People's Republic of China.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Jiang', 'Affiliation': ""Department of Breast and Thyroid Surgery, Southwest Hospital, Army Medical University, Chongqing, People's Republic of China.""}]",The oncologist,['10.1002/onco.13546']
2998,32990324,Anti-cytokine targeted therapies for ANCA-associated vasculitis.,"BACKGROUND


Anti-neutrophilic cytoplasmic antibodies (ANCA)-associated vasculitis (AAV) are a group of rare auto-inflammatory diseases that affects mainly small vessels. AAV includes: granulomatosis with polyangiitis (GPA), microscopic polyangiitis (MPA) and eosinophilic granulomatosis with polyangiitis (EGPA). Anti-cytokine targeted therapy uses biological agents capable of specifically targeting and neutralising cytokine mediators of the inflammatory response.
OBJECTIVES


To assess the benefits and harms of anti-cytokine targeted therapy for adults with AAV.
SEARCH METHODS


We searched the Cochrane Central Register of Controlled Trials (2019, Issue 7), MEDLINE and Embase up to 16 August 2019. We also examined reference lists of articles, clinical trial registries, websites of regulatory agencies and contacted manufacturers.
SELECTION CRITERIA


Randomised controlled trials (RCTs) or controlled clinical trials of targeted anti-cytokine therapy in adults (18 years or older) with AAV compared with placebo, standard therapy or another modality and anti-cytokine therapy of different type or dose.
DATA COLLECTION AND ANALYSIS


We used standard methodological procedures expected by Cochrane.
MAIN RESULTS


We included four RCTs with a total of 440 participants (mean age 48 to 56 years). We analysed the studies in three groups: 1) mepolizumab (300 mg; three separate injections every four weeks for 52 weeks) versus placebo in participants with relapsing or refractory EGPA; 2) belimumab (10 mg/kg on days 0, 14, 28 and every 28 days thereafter until 12 months after the last participant was randomised) or etanercept (25 mg twice a week) with standard therapy (median 25 months) versus placebo with standard therapy (median 19 months) in participants with GPA/MPA; and 3) infliximab (3 mg/kg on days 1 and 14, before the response assessment on day 42) versus rituximab (0.375g/m 2  on days 1, 8, 15 and 22) in participants with refractory GPA for up to 12 months. None of the studies were assessed as low risk of bias in all domains: one study did not report randomisation or blinding methods clearly. Three studies were at high risk and one study was at unclear risk of bias for selective outcome reporting. One trial with 136 participants with relapsing or refractory EGPA compared mepolizumab with placebo during 52 weeks of follow-up and observed one death in the mepolizumab group (1/68, 1.5%) and none in the placebo group (0/68, 0%) (Peto odds ratio (OR) 7.39, 95% confidence interval (CI) 0.15 to 372.38; low-certainty evidence). Low-certainty evidence suggests that more participants in the mepolizumab group had ≥ 24 weeks of accrued remission over 52 weeks compared to placebo (27.9% versus 2.9%; risk ratio (RR) 9.5, 95% CI 2.30 to 39.21), and durable remission within the first 24 weeks sustained until week 52 (19.1% mepolizumab versus 1.5% placebo; RR 13.0, 95% CI 1.75 to 96.63; number needed to treat for an additional beneficial outcome (NNTB) 6, 95% Cl 4 to 13). Mepolizumab probably decreases risk of relapse (55.8% versus 82.4%; RR 0.68, 95% CI 0.53 to 0.86; NNTB 4, 95% CI 3 to 9; moderate-certainty evidence). There was low-certainty evidence regarding similar frequency of adverse events (AEs): total AEs (96.9% versus 94.1%; RR 1.03, 95% CI 0.96 to 1.11), serious AEs (17.7% versus 26.5%; RR 0.67, 95% CI 0.35 to 1.28) and withdrawals due to AEs (2.9% versus 1.5%; RR 2.00, 95% CI 0.19 to 21.54). Disease flares were not measured. Based on two trials with different follow-up periods (mean of 27 months for etanercept study; up to four years for belimumab study) including people with GPA (n = 263) and a small group of participants with MPA (n = 22) analysed together, we found low-certainty evidence suggesting that adding an active drug (etanercept or belimumab) to standard therapy does not increase or reduce mortality (3.4% versus 1.4%; Peto OR 2.45, 95% CI 0.55 to 10.97). Etanercept may have little or no effect on remission (92.3% versus 89.5%; RR 0.97, 95% CI 0.89 to 1.07), durable remission (70% versus 75.3%; RR 0.93, 95% CI 0.77 to 1.11; low-certainty evidence) and disease flares (56% versus 57.1%; RR 0.98, 95% CI 0.76 to 1.27; moderate-certainty evidence). Low-certainty evidence suggests that belimumab does not increase or reduce major relapse (1.9% versus 0%; RR 2.94, 95% CI 0.12 to 70.67) or any AE (92.5% versus 82.7%; RR 1.12, 95% CI 0.97 to 1.29). Low-certainty evidence suggests a similar frequency of serious or severe AEs (47.6% versus 47.6%; RR 1.00, 95% CI 0.80 to 1.27), but more frequent withdrawals due to AEs in the active drug group (11.2%) compared to the placebo group (4.2%), RR 2.66, 95% CI 1.07 to 6.59). One trial involving 17 participants with refractory GPA compared infliximab versus rituximab added to steroids and cytotoxic agents for 12 months. One participant died in each group (Peto OR 0.88, 95% CI, 0.05 to 15.51; 11% versus 12.5%). We have very low-certainty evidence for remission (22% versus 50%, RR 0.44, 95% Cl 0.11 to 1.81) and durable remission (11% versus 50%, RR 0.22, 95% CI 0.03 to 1.60), any severe AE (22.3% versus 12.5%; RR 1.78, 95% CI 0.2 to 16.1) and withdrawals due to AEs (0% versus 0%; RR 2.70, 95% CI 0.13 to 58.24). Disease flare/relapse and the frequency of any AE were not reported.
AUTHORS' CONCLUSIONS


We found four studies but concerns about risk of bias and small sample sizes preclude firm conclusions. We found moderate-certainty evidence that in patients with relapsing or refractory EGPA, mepolizumab compared to placebo probably decreases disease relapse and low-certainty evidence that mepolizumab may increase the probability of accruing at least 24 weeks of disease remission. There were similar frequencies of total and serious AEs in both groups, but the study was too small to reliably assess these outcomes. Mepolizumab may result in little to no difference in mortality. However, there were very few events. In participants with GPA (and a small subgroup of participants with MPA), etanercept or belimumab may increase the probability of withdrawal due to AEs and may have little to no impact on serious AEs. Etanercept may have little or no impact on durable remission and probably does not reduce disease flare.",2020,"One participant died in each group (Peto OR 0.88, 95% CI, 0.05 to 15.51; 11% versus 12.5%).","['AAV includes: granulomatosis with polyangiitis (GPA), microscopic polyangiitis (MPA) and eosinophilic granulomatosis with polyangiitis (EGPA', 'adults with AAV', 'and Embase up to 16 August 2019', 'participants with relapsing or refractory EGPA; 2', 'We included four RCTs with a total of 440 participants (mean age 48 to 56 years', 'participants with GPA (and a small subgroup of participants with MPA', '136 participants with relapsing or refractory EGPA compared', 'people with GPA (n = 263) and a small group of participants with MPA (n = 22', '17 participants with refractory GPA compared', 'adults (18 years or older) with AAV compared with']","['placebo with standard therapy', 'etanercept', 'targeted anti-cytokine therapy', 'infliximab versus rituximab added to steroids and cytotoxic agents', 'Mepolizumab', 'mepolizumab', 'rituximab', 'infliximab', 'placebo', 'etanercept or belimumab', 'Etanercept', 'active drug (etanercept or belimumab', 'belimumab', 'placebo, standard therapy or another modality and anti-cytokine therapy of different type or dose', 'mepolizumab with placebo']","['durable remission', 'adverse events (AEs): total AEs', 'frequencies of total and serious AEs', 'reduce mortality', 'disease relapse', 'disease flares', 'Disease flare/relapse and the frequency of any AE', 'risk of relapse', 'major relapse', 'Disease flares', 'remission', 'severe AE', 'mortality', 'serious AEs']","[{'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0042384', 'cui_str': 'Vasculitis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C3495801', 'cui_str': 'Granulomatosis with polyangiitis'}, {'cui': 'C2347126', 'cui_str': 'Microscopic polyarteritis nodosa'}, {'cui': 'C0008728', 'cui_str': 'Eosinophilic granulomatosis with polyangiitis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0205450', 'cui_str': '4'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4517671', 'cui_str': '263'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0717758', 'cui_str': 'Etanercept'}, {'cui': 'C0199974', 'cui_str': 'Cytokine therapy'}, {'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0010868', 'cui_str': 'Cytotoxin'}, {'cui': 'C0969324', 'cui_str': 'mepolizumab'}, {'cui': 'C1723401', 'cui_str': 'belimumab'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0277556', 'cui_str': 'Recurrent disease'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",17.0,0.668187,"One participant died in each group (Peto OR 0.88, 95% CI, 0.05 to 15.51; 11% versus 12.5%).","[{'ForeName': 'Malgorzata M', 'Initials': 'MM', 'LastName': 'Bala', 'Affiliation': 'Chair of Epidemiology and Preventive Medicine, Department of Hygiene and Dietetics, Jagiellonian University Medical College, Krakow, Poland.'}, {'ForeName': 'Teresa J', 'Initials': 'TJ', 'LastName': 'Malecka-Massalska', 'Affiliation': 'Rheumatology Department, Provincial Hospital, Radzyn Podlaski, Lublin, Poland.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Koperny', 'Affiliation': 'Systematic Reviews Unit, Jagiellonian University Medical College, Krakow, Poland.'}, {'ForeName': 'Joanna F', 'Initials': 'JF', 'LastName': 'Zajac', 'Affiliation': 'Chair of Epidemiology and Preventive Medicine, Department of Hygiene and Dietetics, Jagiellonian University Medical College, Krakow, Poland.'}, {'ForeName': 'Jarosław D', 'Initials': 'JD', 'LastName': 'Jarczewski', 'Affiliation': 'Department of Pathophysiology, Jagiellonian University Medical College, Krakow, Poland.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Szczeklik', 'Affiliation': '2nd Department of Internal Medicine, Jagiellonian University Medical College, Krakow, Poland.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD008333.pub2']
2999,32988292,Efficacy of Melatonin for Sleep Disturbance in Children with Persistent Post-Concussion Symptoms: Secondary Analysis of a Randomized Controlled Trial.,"Sleep disturbances are commonly reported in children with persistent post-concussion symptoms (PPCS). Melatonin treatment is often recommended, yet supporting evidence is scarce. We aimed to evaluate the efficacy of treatment with melatonin for sleep disturbance in youth with PPCS following mild traumatic brain injury (mTBI). This article is a secondary analysis of a clinical trial of melatonin compared with placebo to treat PPCS. Youth (8-18 years of age) with PPCS and significant sleep-related problems (SRPs) at 4-6 weeks post-injury were eligible. Exclusion criteria: significant medical/psychiatric history; previous concussion/mTBI within 3 months. Treatment groups were: placebo, melatonin 3 mg, or melatonin 10 mg. Primary outcome was change in SRPs measured using the Post-Concussion Symptom Inventory (PCSI) after 2 weeks of treatment. Secondary outcomes included change in actigraphy sleep efficiency, duration, onset latency, and wake-after-sleep-onset. Behavior was measured using Behaviour Assessment for Children (2nd edition). Seventy-two participants (mean age 14.0, standard deviation [SD] = 2.6) years; 60% female) with PPCS and significant sleep disturbance were included in the secondary analysis: placebo ( n  = 22); melatonin 3 mg ( n  = 25); melatonin 10 mg ( n  = 25). Sixty-four participants had actigraphy data. SRPs decreased across all groups over time with a significant effect of melatonin 3 mg (3.7; 95% confidence interval [CI]: 2.1, 5.4) compared with placebo (7.4; 95% CI: 4.2, 10.6) and melatonin 10 mg (6.4; 95% CI: 3.6, 9.2). Sleep duration increased in the melatonin 3 mg (43 min; 95% CI: 6, 93) and melatonin 10 mg groups (55 min; 95% CI: 5, 104) compared with placebo. A per protocol analysis demonstrated improved sleep efficiency in the melatonin 10 mg group ( p  = 0.029). No serious adverse events were reported. Depressive symptoms significantly decreased with melatonin 3 mg (-4.7; 95% CI: -9.2, -.2) but not with melatonin 10 mg (-1.4, 95% CI: -5.9, 3.2) treatment compared with placebo. Changes in cognition or behavior were otherwise not significantly different between treatment groups. Short-term melatonin is a well-tolerated treatment for sleep disturbance in youth with PPCS following mTBI. In this context, it may also be associated with a reduction in depressive symptoms.",2020,"Depressive symptoms significantly decreased with Melatonin 3mg (EMD=-4.7; 95%CI:-9.2,-.2) but not Melatonin 10mg (-1.4, 95%CIs:-5.9,3.2) treatment compared to placebo.","['youth with PPCS following mild traumatic brain injury (mTBI', 'Results Seventy-two participants (mean age 14.0(SD=2.6) years; 60% female) with PPCS and significant sleep disturbance', 'Youth (aged 8-18 years) with PPCS and significant sleep-related problems (SRPs) at 4-6 weeks post-injury were eligible', 'children with persistent post-concussion symptoms', 'children with persistent post-concussion symptoms (PPCS']","['placebo', 'Melatonin', 'placebo, Melatonin 3mg, or Melatonin']","['sleep efficiency', 'change in SRPs measured using the Post-Concussion Symptom Inventory (PCSI', 'Sleep disturbances', 'change in actigraphy sleep efficiency, duration, onset latency, and wake-after-sleep-onset', 'Sleep duration', 'sleep disturbance', 'Depressive symptoms', 'SRPs', 'Changes in cognition or behaviour', 'serious adverse events']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0546983', 'cui_str': 'Postconcussion syndrome'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0006107', 'cui_str': 'Concussion injury of brain'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C4319632', 'cui_str': '72'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C1124060', 'cui_str': 'Melatonin 3 MG'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0546983', 'cui_str': 'Postconcussion syndrome'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",72.0,0.703472,"Depressive symptoms significantly decreased with Melatonin 3mg (EMD=-4.7; 95%CI:-9.2,-.2) but not Melatonin 10mg (-1.4, 95%CIs:-5.9,3.2) treatment compared to placebo.","[{'ForeName': 'Karen Maria', 'Initials': 'KM', 'LastName': 'Barlow', 'Affiliation': 'Child Health Research Centre, University of Queensland Faculty of Medicine and Biomedical Sciences, South Brisbane, Queensland, Australia.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Kirk', 'Affiliation': 'Department of Paediatrics, University of Calgary Cumming School of Medicine, Calgary, Alberta, Canada.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Brooks', 'Affiliation': ""Department of Pediatrics, Clinical Neurosciences, and Psychology, Alberta Children's Hospital and University of Calgary, Calgary, Alberta, Canada.""}, {'ForeName': 'Michael Joachim', 'Initials': 'MJ', 'LastName': 'Esser', 'Affiliation': 'Departments of Faculty of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Keith Owen', 'Initials': 'KO', 'LastName': 'Yeates', 'Affiliation': 'Departments of Psychology, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Zemek', 'Affiliation': ""Clinical Research Unit, Children's Hospital of Eastern Ontario, Ottawa, Ontario, Canada.""}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Kirton', 'Affiliation': 'Department of Paediatrics, University of Calgary Cumming School of Medicine, Calgary, Alberta, Canada.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Mikrogianakis', 'Affiliation': ""McMaster Children's Hospital, Hamilton, Ontario, Canada.""}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'MacMaster', 'Affiliation': 'Departments of, Psychiatry and Pediatrics, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Nettel-Aguirre', 'Affiliation': 'Department of Paediatrics, University of Calgary Cumming School of Medicine, Calgary, Alberta, Canada.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Hutchison', 'Affiliation': 'Critical Care Medicine and Pediatrics, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Turley', 'Affiliation': ""Department of Pediatrics, Clinical Neurosciences, and Psychology, Alberta Children's Hospital and University of Calgary, Calgary, Alberta, Canada.""}, {'ForeName': 'Candice', 'Initials': 'C', 'LastName': 'Cameron', 'Affiliation': 'Research Pharmacy, Alberta Health Services, Calgary, Alberta, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hill', 'Affiliation': 'Department of Clinical Neurosciences, University of Calgary Cumming School of Medicine, Calgary, Alberta, Canada.'}, {'ForeName': 'Roslyn', 'Initials': 'R', 'LastName': 'Boyd', 'Affiliation': ""Children's Health Research Centre, University of Queensland, South Brisbane, Queensland, Australia.""}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Dewey', 'Affiliation': 'Department of Paediatrics, University of Calgary Cumming School of Medicine, Calgary, Alberta, Canada.'}]",Journal of neurotrauma,['10.1089/neu.2020.7154']
3000,32988366,Landmark-guided versus modified ultrasound-assisted Paramedian techniques in combined spinal-epidural anesthesia for elderly patients with hip fractures: a randomized controlled trial.,"BACKGROUND


Combined spinal-epidural (CSE) anesthesia is considerably challenging for elderly patients with hip fractures due to spine degeneration and limitations in positioning. This study aimed to investigate the ability of a modified preprocedural ultrasound-guided technique to improve the success rate and efficacy of CSE anesthesia for elderly patients with hip fractures.
METHODS


This prospective, single-blinded, parallel-group randomized controlled trial included 80 patients (aged ≥65 years) who were scheduled for elective hip fracture surgery with CSE anesthesia. Patients were randomly allocated into landmark group (n = 40) or the ultrasound group (n = 40). The primary outcome was first-pass success rate. Secondary outcomes included first-attempt success rate; number of needle insertion attempts; number of needle passes; locating, puncture, and total time; level of block; procedural adverse reactions and postoperative complications; and patient satisfaction score. Patients were blinded to group allocation.
RESULTS


Eighty patients completed the study and were included in the final analysis. The first-pass success rates for the landmark and ultrasound groups were 20 and 70%, respectively (P < 0.001). The first-attempt success rates in the landmark and ultrasound groups were 42.5 and 85%, respectively (P < 0.001). The median number of attempts was lower in ultrasound-assisted group (1 [1]) than landmark-guided group (2 [1, 2]), P < 0.001). The median number of needle passes was lower in ultrasound group (1 [1, 2]) than in landmark-guided group (3 [2, 4], P < 0.001). The locating time (P < 0.001) and total time (P = 0.001) were longer in the ultrasound group, while puncture time was shorter (P = 0.003). No significant difference was found regarding the incidence of adverse reactions and complications. More patients in the ultrasound group had a high satisfaction score of 4-5 (P = 0.007). Interestingly, subgroup analysis demonstrated benefits for ultrasound in patients with scoliosis.
CONCLUSIONS


Modified ultrasound-assisted CSE anesthesia increases first-pass and first-attempt success rates, and reduces needle insertion attempts, passes, and puncture time for elderly patients with hip fracture, especially those with scoliosis. This technique improves patient satisfaction and warrants consideration for application in clinical practice.
TRIAL REGISTRATION


Chinese Clinical Trial Register (identifier, ChiCTR1900020819 ; date of registration, January 20, 2019).",2020,More patients in the ultrasound group had a high satisfaction score of 4-5 (P = 0.007).,"['Eighty patients completed the study and were included in the final analysis', 'elderly patients with hip fracture', '80 patients (aged ≥65\u2009years) who were scheduled for elective hip fracture surgery with CSE anesthesia', 'elderly patients with hip fractures', 'patients with scoliosis']","['Landmark-guided versus modified ultrasound-assisted Paramedian techniques', 'spinal-epidural (CSE) anesthesia', 'combined spinal-epidural anesthesia', 'modified preprocedural ultrasound-guided technique', 'CSE anesthesia', 'Modified ultrasound-assisted CSE anesthesia']","['first-attempt success rate; number of needle insertion attempts; number of needle passes; locating, puncture, and total time; level of block; procedural adverse reactions and postoperative complications; and patient satisfaction score', 'median number of attempts', 'total time', 'puncture time', 'patient satisfaction', 'median number of needle passes', 'locating time', 'high satisfaction score', 'first-pass success rate', 'adverse reactions and complications']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0002913', 'cui_str': 'Epidural anesthesia'}, {'cui': 'C0036439', 'cui_str': 'Scoliosis deformity of spine'}]","[{'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0441993', 'cui_str': 'Paramedian approach'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0228134', 'cui_str': 'Structure of epidural space of spine'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0002913', 'cui_str': 'Epidural anesthesia'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0451370', 'cui_str': 'Patient satisfaction score'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444693', 'cui_str': 'First pass'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",80.0,0.153947,More patients in the ultrasound group had a high satisfaction score of 4-5 (P = 0.007).,"[{'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Qu', 'Affiliation': 'Guangzhou University of Chinese Medicine, Guangzhou, 510405, Guangdong, China.'}, {'ForeName': 'Luying', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Guangzhou University of Chinese Medicine, Guangzhou, 510405, Guangdong, China.'}, {'ForeName': 'Yuling', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Guangzhou University of Chinese Medicine, Guangzhou, 510405, Guangdong, China.'}, {'ForeName': 'Mengting', 'Initials': 'M', 'LastName': 'Jiang', 'Affiliation': 'Guangzhou University of Chinese Medicine, Guangzhou, 510405, Guangdong, China.'}, {'ForeName': 'Caineng', 'Initials': 'C', 'LastName': 'Wu', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, 510405, Guangdong, China.'}, {'ForeName': 'Wuhua', 'Initials': 'W', 'LastName': 'Ma', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, 510405, Guangdong, China.'}, {'ForeName': 'Yuhui', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, 510405, Guangdong, China. liliuyuhui@126.com.'}]",BMC anesthesiology,['10.1186/s12871-020-01172-x']
3001,32988690,A randomized controlled trial of an online immunization curriculum.,"INTRODUCTION


Immunization education for physicians-in-training is crucial to address vaccine concerns in clinical practice. Vaccine education is not standardized across residency programs. The Collaboration for Vaccination Education and Research (CoVER) team developed an online curriculum for pediatric (Peds) and family medicine (FM) residents.
METHODS


A cluster randomized controlled trial (RCT) was performed during the 2017-2018 academic year to evaluate the CoVER curriculum. A convenience sample of residency institutions were randomly allocated to the intervention or control group, with stratification by residency type. The intervention, the CoVER curriculum, consisted of four online modules and an in-person training guide. Control sites continued with their standard vaccine education. Pre-intervention and post-intervention surveys were emailed to residents in both groups. The primary outcomes compared between groups were changes in ""vaccine knowledge,"" ""vaccine attitudes/hesitancy,"" and ""self-confidence"" in immunization communication. The team assessing outcomes was unblinded to assignments. Hierarchical general linear model was used to adjust for residency type and residency year; residency site was modeled as a random effect.
RESULTS


Overall, 1444 residents from 31 residency programs were eligible to participate (734 intervention, 710 control). The pre-intervention response rate was 730 (51%) and post-intervention was 526 (36%). Average knowledge scores increased from pre-intervention (control 53%; CoVER 53%) to post-intervention (control 58%; CoVER 60%). Increases in vaccine knowledge among FM residents were greater for CoVER compared to controls (p = 0.041). Vaccine hesitancy was more common among FM (23%) than Peds (10%) residents. In all three residency years, residents in the CoVER group showed greater increases in self-confidence in ability to discuss vaccines with parents/patients (p < 0.03) compared to control group.
CONCLUSION


The CoVER curriculum is an effective model to standardize immunization education of physicians-in-training. This RCT demonstrated the effectiveness of the CoVER curriculum to improve resident confidence in their ability to discuss vaccines with parents and patients.",2020,"In all three residency years, residents in the CoVER group showed greater increases in self-confidence in ability to discuss vaccines with parents/patients (p < 0.03) compared to control group.
","['A convenience sample of residency institutions', '1444 residents from 31 residency programs were eligible to participate (734 intervention, 710 control', '2017-2018 academic year to evaluate the CoVER curriculum']",['online immunization curriculum'],"['vaccine knowledge,"" ""vaccine attitudes/hesitancy,"" and ""self-confidence"" in immunization communication', 'Vaccine hesitancy', 'vaccine knowledge', 'self-confidence', 'pre-intervention response rate', 'Average knowledge scores']","[{'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0035182', 'cui_str': 'Residency'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}]","[{'cui': 'C0020971', 'cui_str': 'Immunization'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0152032', 'cui_str': 'Delay when starting to pass urine'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0020971', 'cui_str': 'Immunization'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0637888,"In all three residency years, residents in the CoVER group showed greater increases in self-confidence in ability to discuss vaccines with parents/patients (p < 0.03) compared to control group.
","[{'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Pahud', 'Affiliation': ""Children's Mercy Hospital, Department of Pediatrics, UMKC School of Medicine, 2401 Gillham Road, Kansas City, MO 64108, United States. Electronic address: bapahud@cmh.edu.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Elizabeth Williams', 'Affiliation': ""Vanderbilt Department of Pediatrics, Division of General Pediatrics, 2200 Children's Way, 8232 Doctors' Office Tower, Nashville, TN 37232, United States. Electronic address: elizabeth.williams@vumc.org.""}, {'ForeName': 'Brian R', 'Initials': 'BR', 'LastName': 'Lee', 'Affiliation': ""Children's Mercy Hospital, Department of Pediatrics, UMKC School of Medicine, 2401 Gillham Road, Kansas City, MO 64108, United States. Electronic address: blee@cmh.edu.""}, {'ForeName': 'Kadriye O', 'Initials': 'KO', 'LastName': 'Lewis', 'Affiliation': ""Children's Mercy Hospital, Department of Pediatrics, UMKC School of Medicine, 2401 Gillham Road, Kansas City, MO 64108, United States. Electronic address: kolewis@cmh.edu.""}, {'ForeName': 'Donald B', 'Initials': 'DB', 'LastName': 'Middleton', 'Affiliation': 'University of Pittsburgh Medical Center, 815 Freeport Road, Pittsburgh, PA 15215, United States. Electronic address: middletondb@upmc.edu.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Clark', 'Affiliation': ""Children's Mercy Hospital, Department of Pediatrics, UMKC School of Medicine, 2401 Gillham Road, Kansas City, MO 64108, United States. Electronic address: sclark2@cmh.edu.""}, {'ForeName': 'Sharon G', 'Initials': 'SG', 'LastName': 'Humiston', 'Affiliation': ""Children's Mercy Hospital, Department of Pediatrics, UMKC School of Medicine, 2401 Gillham Road, Kansas City, MO 64108, United States. Electronic address: sghumiston@cmh.edu.""}]",Vaccine,['10.1016/j.vaccine.2020.09.043']
3002,32987448,Interventions for preventing mastitis after childbirth.,"BACKGROUND


Despite the health benefits of breastfeeding, initiation and duration rates continue to fall short of international guidelines. Many factors influence a woman's decision to wean; the main reason cited for weaning is associated with lactation complications, such as mastitis. Mastitis is an inflammation of the breast, with or without infection. It can be viewed as a continuum of disease, from non-infective inflammation of the breast to infection that may lead to abscess formation.
OBJECTIVES


To assess the effectiveness of preventive strategies (for example, breastfeeding education, pharmacological treatments and alternative therapies) on the occurrence or recurrence of non-infective or infective mastitis in breastfeeding women post-childbirth.
SEARCH METHODS


We searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (3 October 2019), and reference lists of retrieved studies.
SELECTION CRITERIA


We included randomised controlled trials of interventions for preventing mastitis in postpartum breastfeeding women. Quasi-randomised controlled trials and trials reported only in abstract form were eligible. We attempted to contact the authors to obtain any unpublished results, wherever possible.  Interventions for preventing mastitis may include: probiotics, specialist breastfeeding advice and holistic approaches.   DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trials for inclusion and risk of bias, extracted data and assessed the certainty of the evidence using GRADE.
MAIN RESULTS


We included 10 trials (3034 women). Nine trials (2395 women) contributed data. Generally, the trials were at low risk of bias in most domains but some were high risk for blinding, attrition bias, and selective reporting. Selection bias (allocation concealment) was generally unclear. The certainty of evidence was downgraded due to risk of bias and to imprecision (low numbers of women participating in the trials). Conflicts of interest on the part of trial authors, and the involvement of industry funders may also have had an impact on the certainty of the evidence. Most trials reported our primary outcome of incidence of mastitis but there were almost no data relating to adverse effects, breast pain, duration of breastfeeding, nipple damage, breast abscess or recurrence of mastitis. Probiotics versus placebo Probiotics may reduce the risk of mastitis more than placebo (risk ratio (RR) 0.51, 95% confidence interval (CI) 0.35 to 0.75; 2 trials; 399 women; low-certainty evidence). It is uncertain if probiotics reduce the risk of breast pain or nipple damage because the certainty of evidence is very low. Results for the biggest of these trials (639 women) are currently unavailable due to a contractual agreement between the probiotics supplier and the trialists. Adverse effects were reported in one trial, where no woman in either group experienced any adverse effects. Antibiotics versus placebo or usual care The risk of mastitis may be similar between antibiotics and usual care or placebo (RR 0.37, 95% CI 0.10 to 1.34; 3 trials; 429 women; low-certainty evidence). The risk of mastitis may be similar between antibiotics and fusidic acid ointment (RR 0.22, 95% CI 0.03 to 1.81; 1 trial; 36 women; low-certainty evidence) or mupirocin ointment (RR 0.44, 95% CI 0.05 to 3.89; 1 trial; 44 women; low-certainty evidence) but we are uncertain due to the wide CIs. None of the trials reported adverse effects. Topical treatments versus breastfeeding advice The risk of mastitis may be similar between fusidic acid ointment and breastfeeding advice (RR 0.77, 95% CI 0.27 to 2.22; 1 trial; 40 women; low-certainty evidence) and mupirocin ointment and breastfeeding advice (RR 0.39, 95% CI 0.12 to 1.35; 1 trial; 48 women; low-certainty evidence) but we are uncertain due to the wide CIs. One trial (42 women) compared topical treatments to each other. The risk of mastitis may be similar between fusidic acid and mupirocin (RR 0.51, 95% CI 0.13 to 2.00; low-certainty evidence) but we are uncertain due to the wide CIs. Adverse events were not reported. Specialist breastfeeding education versus usual care The risk of mastitis (RR 0.93, 95% CI 0.17 to 4.95; 1 trial; 203 women; low-certainty evidence) and breast pain (RR 0.93, 95% CI 0.36 to 2.37; 1 trial; 203 women; low-certainty evidence) may be similar but we are uncertain due to the wide CIs. Adverse events were not reported. Anti-secretory factor-inducing cereal versus standard cereal The risk of mastitis (RR 0.24, 95% CI 0.03 to 1.72; 1 trial; 29 women; low-certainty evidence) and recurrence of mastitis (RR 0.39, 95% CI 0.03 to 4.57; 1 trial; 7 women; low-certainty evidence) may be similar but we are uncertain due to the wide CIs. Adverse events were not reported. Acupoint massage versus routine care Acupoint massage probably reduces the risk of mastitis compared to routine care (RR 0.38, 95% CI 0.19 to 0.78;1 trial; 400 women; moderate-certainty evidence) and breast pain (RR 0.13, 95% CI 0.07 to 0.23; 1 trial; 400 women; moderate-certainty evidence). Adverse events were not reported. Breast massage and low frequency pulse treatment versus routine care Breast massage and low frequency pulse treatment may reduce risk of mastitis (RR 0.03, 95% CI 0.00 to 0.21; 1 trial; 300 women; low-certainty evidence). Adverse events were not reported.
AUTHORS' CONCLUSIONS


There is some evidence that acupoint massage is probably better than routine care, probiotics may be better than placebo, and breast massage and low frequency pulse treatment may be better than routine care for preventing mastitis. However, it is important to note that we are aware of at least one large trial investigating probiotics whose results have not been made public, therefore, the evidence presented here is incomplete. The available evidence regarding other interventions, including breastfeeding education, pharmacological treatments and alternative therapies, suggests these may be little better than routine care for preventing mastitis but our conclusions are uncertain due to the low certainty of the evidence. Future trials should recruit sufficiently large numbers of women in order to detect clinically important differences between interventions and results of future trials should be made publicly available.",2020,"The risk of mastitis (RR 0.93, 95% CI 0.17 to 4.95; 1 trial; 203 women; low-certainty evidence) and breast pain (RR 0.93, 95% CI 0.36 to 2.37; 1 trial; 203 women; low-certainty evidence) may be similar but we are uncertain due to the wide CIs.","['10 trials (3034 women', 'postpartum breastfeeding women']","['fusidic acid ointment', 'Anti-secretory factor-inducing cereal versus standard cereal', 'Antibiotics versus placebo or usual care', 'Acupoint massage versus routine care Acupoint massage', 'Breast massage and low frequency pulse treatment versus routine care Breast massage and low frequency pulse treatment', 'placebo', 'Probiotics versus placebo Probiotics', 'Specialist breastfeeding education versus usual care', 'mupirocin ointment', 'acupoint massage']","['breast pain', 'recurrence of mastitis', 'incidence of mastitis', 'Adverse events', 'adverse effects', 'Adverse effects', 'risk of mastitis', 'occurrence or recurrence of non-infective or infective mastitis', 'adverse effects, breast pain, duration of breastfeeding, nipple damage, breast abscess or recurrence of mastitis']","[{'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}]","[{'cui': 'C0016875', 'cui_str': 'fusidic acid'}, {'cui': 'C0028912', 'cui_str': 'Ointment'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0007757', 'cui_str': 'Cereal'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001302', 'cui_str': 'Acupuncture point'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0418914', 'cui_str': 'Breastfeeding education'}, {'cui': 'C1247033', 'cui_str': 'Mupirocin Topical Ointment'}]","[{'cui': 'C0024902', 'cui_str': 'Pain of breast'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0024894', 'cui_str': 'Mastitis'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0269245', 'cui_str': 'Infective mastitis'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0028109', 'cui_str': 'Nipple structure'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0151463', 'cui_str': 'Abscess of breast'}]",42.0,0.488221,"The risk of mastitis (RR 0.93, 95% CI 0.17 to 4.95; 1 trial; 203 women; low-certainty evidence) and breast pain (RR 0.93, 95% CI 0.36 to 2.37; 1 trial; 203 women; low-certainty evidence) may be similar but we are uncertain due to the wide CIs.","[{'ForeName': 'Maree A', 'Initials': 'MA', 'LastName': 'Crepinsek', 'Affiliation': 'Southern Cross University, Gold Coast, Australia.'}, {'ForeName': 'Emily A', 'Initials': 'EA', 'LastName': 'Taylor', 'Affiliation': 'School of Rural Medicine, University of New England, Main Beach, Australia.'}, {'ForeName': 'Keryl', 'Initials': 'K', 'LastName': 'Michener', 'Affiliation': 'Herston Health Sciences Library, University of Queensland Library, Brisbane, Australia.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Stewart', 'Affiliation': 'c/o Cochrane Incontinence, Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD007239.pub4']
3003,32996027,Use of Text Messaging (SMS) for the Management of Side Effects in Cancer Patients Undergoing Chemotherapy Treatment: a Randomized Controlled Trial.,"Cancer patients are often not sufficiently oriented to manage side effects at home. Sending text messages with self-care guidelines aimed managing side effects is the main objective of this randomized controlled trial. Patients who started outpatient chemotherapy treatment between March and December 2017 at a hospital in southern Brazil were invited to participate in this study and were allocated to the intervention or control group (ratio 1: 1). Each patient in the intervention group received a daily SMS (short message service) with some guidance on management or prevention of side effects. All text messages were sent to the intervention group patients in an automated and tailored way by our app called cHEmotHErApp. Side effects experienced by patients were verified using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30). Results showed intervention group patients experienced fewer side effects compared to the control group in cycle 1 (p < 0.05), in general. In addition, intervention group experienced less nausea in relation to the control group, in the cycle 1 and cycle 2 (p < 0.05). This study indicate text messaging may be a tool for supporting side effect management in patients receiving chemotherapy. This study was enrolled in ClinicalTrials.gov with the identification number NCT03087422. This research was performed in accordance with the Declaration of Helsinki.",2020,"Results showed intervention group patients experienced fewer side effects compared to the control group in cycle 1 (p < 0.05), in general.","['Patients who started outpatient chemotherapy treatment between March and December 2017 at a hospital in southern Brazil', 'Cancer Patients', 'patients receiving chemotherapy', 'Cancer patients']","['Text Messaging (SMS', 'daily SMS (short message service']","['nausea', 'European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30', 'side effects']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0451149', 'cui_str': 'EORTC - Quality of life questionnaire'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",,0.069354,"Results showed intervention group patients experienced fewer side effects compared to the control group in cycle 1 (p < 0.05), in general.","[{'ForeName': 'Timóteo Matthies', 'Initials': 'TM', 'LastName': 'Rico', 'Affiliation': 'Instituto Federal Sul-Rio-Grandense, Corredor das Tropas, 801, Jaguarão - Rio Grande do Sul, Jaguarão, RS, 96300-000, Brazil. timoteomr@gmail.com.'}, {'ForeName': 'Karina', 'Initials': 'K', 'LastName': 'Dos Santos Machado', 'Affiliation': 'C3 - Centro de Ciências Computacionais, Universidade Federal do Rio Grande, Rio Grande do Sul, Rio Grande, Brazil.'}, {'ForeName': 'Vanessa Pellegrini', 'Initials': 'VP', 'LastName': 'Fernandes', 'Affiliation': 'Hospital Escola, Universidade Federal de Pelotas, Rio Grande do Sul, Pelotas, Brazil.'}, {'ForeName': 'Samanta Winck', 'Initials': 'SW', 'LastName': 'Madruga', 'Affiliation': 'Hospital Escola, Universidade Federal de Pelotas, Rio Grande do Sul, Pelotas, Brazil.'}, {'ForeName': 'Mateus Madail', 'Initials': 'MM', 'LastName': 'Santin', 'Affiliation': 'Hospital Escola, Universidade Federal de Pelotas, Rio Grande do Sul, Pelotas, Brazil.'}, {'ForeName': 'Cristiane Rios', 'Initials': 'CR', 'LastName': 'Petrarca', 'Affiliation': 'Hospital Escola, Universidade Federal de Pelotas, Rio Grande do Sul, Pelotas, Brazil.'}, {'ForeName': 'Samuel Carvalho', 'Initials': 'SC', 'LastName': 'Dumith', 'Affiliation': 'Programa de Pós Graduação em Ciências da Saúde, Universidade Federal do Rio Grande, Rio Grande do Sul, Rio Grande, Brazil.'}]",Journal of medical systems,['10.1007/s10916-020-01663-x']
3004,32996442,Effectiveness of a housing support team intervention with a recovery-oriented approach on hospital and emergency department use by homeless people with severe mental illness: a randomised controlled trial.,"AIMS


Many people who are homeless with severe mental illnesses are high users of healthcare services and social services, without reducing widen health inequalities in this vulnerable population. This study aimed to determine whether independent housing with mental health support teams with a recovery-oriented approach (Housing First (HF) program) for people who are homeless with severe mental disorders improves hospital and emergency department use.
METHODS


We did a randomised controlled trial in four French cities: Lille, Marseille, Paris and Toulouse. Participants were eligible if they were 18 years or older, being absolutely homeless or precariously housed, with a diagnosis of schizophrenia (SCZ) or bipolar disorder (BD) and were required to have a high level of needs (moderate-to-severe disability and past hospitalisations over the last 5 years or comorbid alcohol or substance use disorder). Participants were randomly assigned (1:1) to immediate access to independent housing and support from the Assertive Community Treatment team (social worker, nurse, doctor, psychiatrist and peer worker) (HF group) or treatment as usual (TAU group) namely pre-existing dedicated homeless-targeted programs and services. Participants and interviewers were unmasked to assignment. The primary outcomes were the number of emergency department (ED) visits, hospitalisation admissions and inpatient days at 24 months. Secondary outcomes were recovery (Recovery Assessment Scale), quality of life (SQOL and SF36), mental health symptoms, addiction issues, stably housed days and cost savings from a societal perspective. Intention-to-treat analysis was performed.
RESULTS


Eligible patients were randomly assigned to the HF group (n = 353) or TAU group (n = 350). No differences were found in the number of hospital admissions (relative risk (95% CI), 0.96 (0.76-1.21)) or ED visits (0.89 (0.66-1.21)). Significantly less inpatient days were found for HF v. TAU (0.62 (0.48-0.80)). The HF group exhibited higher housing stability (difference in slope, 116 (103-128)) and higher scores for sub-dimensions of S-QOL scale (psychological well-being and autonomy). No differences were found for physical composite score SF36, mental health symptoms and rates of alcohol or substance dependence. Mean difference in costs was €-217 per patient over 24 months in favour of the HF group. HF was associated with cost savings in healthcare costs (RR 0.62(0.48-0.78)) and residential costs (0.07 (0.05-0.11)).
CONCLUSION


An immediate access to independent housing and support from a mental health team resulted in decreased inpatient days, higher housing stability and cost savings in homeless persons with SCZ or BP disorders.",2020,Significantly less inpatient days were found for HF v. TAU (0.62 (0.48-0.80)).,"['people who are homeless with severe mental disorders improves hospital and emergency department use', 'Eligible patients', 'four French cities: Lille, Marseille, Paris and Toulouse', 'people who are homeless with severe mental illnesses', 'homeless persons with SCZ or BP disorders', 'homeless people with severe mental illness', 'Participants were eligible if they were 18 years or older, being absolutely homeless or precariously housed, with a diagnosis of schizophrenia (SCZ) or bipolar disorder (BD) and were required to have a high level of needs (moderate-to-severe disability and past hospitalisations over the last 5 years or comorbid alcohol or substance use disorder']","['immediate access to independent housing and support from the Assertive Community Treatment team (social worker, nurse, doctor, psychiatrist and peer worker) (HF group) or treatment as usual (TAU group) namely pre-existing dedicated homeless-targeted programs and services', 'HF', 'housing support team intervention with a recovery-oriented approach', 'housing with mental health support teams with a recovery-oriented approach (Housing First (HF) program', 'TAU']","['physical composite score SF36, mental health symptoms and rates of alcohol or substance dependence', 'cost savings in healthcare costs', 'number of hospital admissions', 'number of emergency department (ED) visits, hospitalisation admissions and inpatient days at 24 months', 'housing stability and cost savings', 'residential costs', 'recovery (Recovery Assessment Scale), quality of life (SQOL and SF36), mental health symptoms, addiction issues, stably housed days and cost savings from a societal perspective', 'housing stability', 'Mean difference in costs', 'higher scores for sub-dimensions of S-QOL scale (psychological well-being and autonomy']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0237154', 'cui_str': 'Homeless'}, {'cui': 'C4046029', 'cui_str': 'Mental Disorders, Severe'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376246', 'cui_str': 'French language'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0030561', 'cui_str': 'Paris'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0205136', 'cui_str': 'Over'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C2713614', 'cui_str': 'Assertive Community Treatment'}, {'cui': 'C0037444', 'cui_str': 'Social worker'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0033872', 'cui_str': 'Psychiatrist'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0237154', 'cui_str': 'Homeless'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0038580', 'cui_str': 'Substance dependence'}, {'cui': 'C0085550', 'cui_str': 'Cost Savings'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0085281', 'cui_str': 'Addiction'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}]",,0.227089,Significantly less inpatient days were found for HF v. TAU (0.62 (0.48-0.80)).,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Tinland', 'Affiliation': 'Aix-Marseille University, School of medicine - La Timone Medical Campus, EA 3279: CEReSS - Health Service Research and Quality of Life Center, F-13005Marseille, France.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Loubière', 'Affiliation': 'Aix-Marseille University, School of medicine - La Timone Medical Campus, EA 3279: CEReSS - Health Service Research and Quality of Life Center, F-13005Marseille, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Boucekine', 'Affiliation': 'Aix-Marseille University, School of medicine - La Timone Medical Campus, EA 3279: CEReSS - Health Service Research and Quality of Life Center, F-13005Marseille, France.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Boyer', 'Affiliation': 'Aix-Marseille University, School of medicine - La Timone Medical Campus, EA 3279: CEReSS - Health Service Research and Quality of Life Center, F-13005Marseille, France.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Fond', 'Affiliation': 'Aix-Marseille University, School of medicine - La Timone Medical Campus, EA 3279: CEReSS - Health Service Research and Quality of Life Center, F-13005Marseille, France.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Girard', 'Affiliation': 'Aix-Marseille University, School of medicine - La Timone Medical Campus, EA 3279: CEReSS - Health Service Research and Quality of Life Center, F-13005Marseille, France.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Auquier', 'Affiliation': 'Aix-Marseille University, School of medicine - La Timone Medical Campus, EA 3279: CEReSS - Health Service Research and Quality of Life Center, F-13005Marseille, France.'}]",Epidemiology and psychiatric sciences,['10.1017/S2045796020000785']
3005,32916250,Impact of dedicated infectious disease teamwork on the treatment and prognosis of patients with diabetic foot infection.,"OBJECTIVE


The aim was to develop and evaluate the impact of a new model in which the infectious disease (ID) physician and pharmacist work together to treat diabetic foot infections (DFIs).
METHODS


A quasi-experimental before-after study was conducted. The medical charts of inpatients with DFI admitted between April 1, 2017 and March 31, 2018 were reviewed retrospectively (control group, n = 30). Inpatients diagnosed with DFI between April 1, 2018 and March 31, 2019 were enrolled prospectively as the intervention group and received treatment through dedicated ID teamwork (intervention group, n = 35).
RESULTS


The distribution of infection severity and levels of metabolic criteria were similar in the two groups. Compared with the control group, the intervention group received adequate initial empirical treatment more frequently (96.8% vs 43.5%, p < 0.001) and had a shorter median duration of fever (1 day vs 7.5 days, p < 0.001). Rates of healing and relapse within 6 months were similar in the two groups, although the intervention group showed more sites of osteomyelitis (p = 0.036) and a higher percentage of polymicrobial infections (48.6% vs 10.0%, p = 0.001).
CONCLUSION


The early and full participation of ID physicians and pharmacists in the treatment of DFI facilitated targeted antimicrobial treatment and improved patient outcomes.",2020,"Rates of healing and relapse within 6 months were similar in the two groups, although the intervention group showed more sites of osteomyelitis (p = 0.036) and a higher percentage of polymicrobial infections (48.6% vs 10.0%, p = 0.001).
","['inpatients with DFI admitted between April 1, 2017 and March 31, 2018 were reviewed retrospectively (control group, n = 30', 'patients with diabetic foot infection', 'Inpatients diagnosed with DFI between April 1, 2018 and March 31, 2019 were enrolled prospectively as the intervention group and received treatment through dedicated ID teamwork (intervention group, n = 35']",['dedicated infectious disease teamwork'],"['Rates of healing and relapse', 'sites of osteomyelitis', 'distribution of infection severity and levels of metabolic criteria', 'polymicrobial infections', 'shorter median duration of fever']","[{'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0744130', 'cui_str': 'Diabetic foot infection'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]","[{'cui': 'C0009450', 'cui_str': 'Communicable disease'}]","[{'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C2945843', 'cui_str': 'Site of'}, {'cui': 'C0029443', 'cui_str': 'Osteomyelitis'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0517627', 'cui_str': 'Infection status'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0275524', 'cui_str': 'Mixed infectious disease'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0015967', 'cui_str': 'Fever'}]",,0.0350705,"Rates of healing and relapse within 6 months were similar in the two groups, although the intervention group showed more sites of osteomyelitis (p = 0.036) and a higher percentage of polymicrobial infections (48.6% vs 10.0%, p = 0.001).
","[{'ForeName': 'Xiang-Yan', 'Initials': 'XY', 'LastName': 'Li', 'Affiliation': 'Department of Anti-infection, Institute of Clinical Pharmacology, Peking University First Hospital, No. 8, Xishiku Street, Xicheng District, Beijing 100034, China. Electronic address: lixyan03598@pkufh.com.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Qi', 'Affiliation': 'Department of Plastic Surgery and Burns, Peking University First Hospital, No. 8, Xishiku Street, Xicheng District, Beijing 100034, China. Electronic address: 04983@pkufh.com.'}, {'ForeName': 'Shuo-Han', 'Initials': 'SH', 'LastName': 'Tian', 'Affiliation': 'Department of Pharmacy, Peking University First Hospital, No. 8, Xishiku Street, Xicheng District, Beijing 100034, China. Electronic address: tianshuohan@126.com.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'He', 'Affiliation': 'Department of Plastic Surgery and Burns, Peking University First Hospital, No. 8, Xishiku Street, Xicheng District, Beijing 100034, China. Electronic address: doctorherui@163.com.'}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Jiang', 'Affiliation': 'Department of Plastic Surgery and Burns, Peking University First Hospital, No. 8, Xishiku Street, Xicheng District, Beijing 100034, China. Electronic address: jiangshan_beijing@163.com.'}, {'ForeName': 'Hui-Juan', 'Initials': 'HJ', 'LastName': 'Li', 'Affiliation': 'Department of Plastic Surgery and Burns, Peking University First Hospital, No. 8, Xishiku Street, Xicheng District, Beijing 100034, China. Electronic address: lihuijuan2010@126.com.'}]",International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases,['10.1016/j.ijid.2020.08.085']
3006,32994371,Shuxuetong for Prevention of recurrence in Acute Cerebrovascular events with Embolism (SPACE) trial: rationale and design.,"BACKGROUNDS


Embolic stroke is one of the main mechanisms of ischaemic stroke. Even if treated with recommended antithrombotic agents, stroke recurrence remains high. The Shuxuetong injection, a purified extract of traditional Chinese medicine widely used for thrombus diseases in clinical practice in China, could be a promising agent to prevent stroke recurrence.
AIMS


To describe the design of the Shuxuetong injection for prevention of recurrence in acute ischaemic stroke with embolism mechanisms.
DESIGN


The Shuxuetong for Prevention of recurrence in Acute Cerebrovascular events with Embolism (SPACE) trial is a multicentre, randomised, double-blind, placebo-controlled, parallel-group, superiority trial to evaluate the efficacy and safety of Shuxuetong injection in reducing recurrence or silent new ischaemic lesions on patients with acute embolic stroke within 10 days. An estimated 2416 patients with embolic stroke within 72 hours of symptom onset from 80 hospitals will be randomly assigned to one of two groups receiving Shuxuetong injection or placebo injection for 10 days. The primary endpoint is symptomatic or asymptomatic new cerebral infarction within 10 days after randomisation.
CONCLUSION


The SPACE Trial will provide valuable evidence for the efficacy and safety of Shuxuetong injection for the prevention of stroke recurrence in patients with imaging-defined embolic stroke.
CLINICAL TRIAL REGISTRATION


NCT03090113.",2020,"The Shuxuetong for Prevention of recurrence in Acute Cerebrovascular events with Embolism (SPACE) trial is a multicentre, randomised, double-blind, placebo-controlled, parallel-group, superiority trial to evaluate the efficacy and safety of Shuxuetong injection in reducing recurrence or silent new ischaemic lesions on patients with acute embolic stroke within 10 days.","['acute ischaemic stroke with embolism mechanisms', '2416 patients with embolic stroke within 72\u2009hours of symptom onset from 80 hospitals', 'patients with imaging-defined embolic stroke', 'patients with acute embolic stroke within 10 days']","['placebo', 'Shuxuetong injection', 'Shuxuetong injection or placebo injection']","['efficacy and safety', 'symptomatic or asymptomatic new cerebral infarction']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0013922', 'cui_str': 'Embolism'}, {'cui': 'C0441712', 'cui_str': 'Mechanisms'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0262469', 'cui_str': 'Embolic stroke'}, {'cui': 'C1292423', 'cui_str': '72 hours'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2606430', 'cui_str': 'shuxuetong'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0007785', 'cui_str': 'Cerebral infarction'}]",2416.0,0.57285,"The Shuxuetong for Prevention of recurrence in Acute Cerebrovascular events with Embolism (SPACE) trial is a multicentre, randomised, double-blind, placebo-controlled, parallel-group, superiority trial to evaluate the efficacy and safety of Shuxuetong injection in reducing recurrence or silent new ischaemic lesions on patients with acute embolic stroke within 10 days.","[{'ForeName': 'Hong-Qiu', 'Initials': 'HQ', 'LastName': 'Gu', 'Affiliation': 'China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Xue-Wei', 'Initials': 'XW', 'LastName': 'Xie', 'Affiliation': 'China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Jing', 'Affiliation': 'China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Meng', 'Affiliation': 'China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Lv', 'Affiliation': 'China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Jian-Dong', 'Initials': 'JD', 'LastName': 'Yu', 'Affiliation': 'China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Xiang-Ping', 'Initials': 'XP', 'LastName': 'Lv', 'Affiliation': 'China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yi-Long', 'Initials': 'YL', 'LastName': 'Wang', 'Affiliation': 'China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yong-Jun', 'Initials': 'YJ', 'LastName': 'Wang', 'Affiliation': 'China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China yongjunwang@ncrcnd.org.cn.'}]",Stroke and vascular neurology,['10.1136/svn-2019-000293']
3007,31262489,The SPRINT trial suggests that markers of tubule cell function in the urine associate with risk of subsequent acute kidney injury while injury markers elevate after the injury.,"Urine markers can quantify tubular function including reabsorption (α-1 microglobulin [α1m]) and β-2-microglobulin [β2m]) and protein synthesis (uromodulin). Individuals with tubular dysfunction may be less able to compensate to insults than those without, despite similar estimated glomerular filtration rate (eGFR) and albuminuria. Among Systolic Blood Pressure Intervention Trial (SPRINT) participants with an eGFR under 60 ml/min/1.73m 2 , we measured urine markers of tubular function and injury (neutrophil gelatinase-associated lipocalin [NGAL], kidney injury molecule-1 [KIM-1], interleukin-18 [IL-18], monocyte chemoattractant protein-1, and chitinase-3-like protein [YKL-40]) at baseline. Cox models evaluated associations with subsequent acute kidney injury (AKI) risk, adjusting for clinical risk factors, baseline eGFR and albuminuria, and the tubular function and injury markers. In a random subset, we remeasured biomarkers after four years, and compared changes in biomarkers in those with and without intervening AKI. Among 2351 participants, 184 experienced AKI during 3.8 years mean follow-up. Lower uromodulin (hazard ratio per two-fold higher (0.68, 95% confidence interval [0.56, 0.83]) and higher α1m (1.20; [1.01, 1.44]) were associated with subsequent AKI, independent of eGFR and albuminuria. None of the five injury markers were associated with eventual AKI. In the random subset of 947 patients with repeated measurements, the 59 patients with intervening AKI versus without had longitudinal increases in urine NGAL, IL-19, and YKL-40 and only 1 marker of tubule function (α1m). Thus, joint evaluation of tubule function and injury provided novel insights to factors predisposing to AKI, and responses to kidney injury.",2019,"Individuals with tubular dysfunction may be less able to compensate to insults than those without, despite similar estimated glomerular filtration rate (eGFR) and albuminuria.","['947 patients with repeated measurements, the 59 patients with intervening AKI', 'Individuals with tubular dysfunction', '2351 participants, 184 experienced AKI during 3.8 years mean follow-up']",[],"['tubular function including reabsorption (α-1 microglobulin [α1m]) and β-2-microglobulin [β2m]) and protein synthesis (uromodulin', 'urine NGAL, IL-19, and YKL-40 and only 1 marker of tubule function (α1m', 'eventual AKI', 'acute kidney injury (AKI) risk, adjusting for clinical risk factors, baseline eGFR and albuminuria, and the tubular function and injury markers', 'urine markers of tubular function and injury (neutrophil gelatinase-associated lipocalin [NGAL], kidney injury molecule-1 [KIM-1], interleukin-18 [IL-18], monocyte chemoattractant protein-1, and chitinase-3-like protein [YKL-40', 'glomerular filtration rate (eGFR) and albuminuria']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332208', 'cui_str': 'Tubular'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C4517616', 'cui_str': '184'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]",[],"[{'cui': 'C0332208', 'cui_str': 'Tubular'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0597295', 'cui_str': 'Genetic translation'}, {'cui': 'C0077918', 'cui_str': 'Uromucoid protein'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0215955', 'cui_str': 'LCN2 protein, human'}, {'cui': 'C1447896', 'cui_str': 'IL19 protein, human'}, {'cui': 'C0528649', 'cui_str': 'CHI3L1 protein, human'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0206528', 'cui_str': 'Gelatinase'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C1956074', 'cui_str': 'Lipocalin'}, {'cui': 'C1313407', 'cui_str': 'HAVCR1 protein, human'}, {'cui': 'C0383327', 'cui_str': 'Interleukin 18'}, {'cui': 'C0128897', 'cui_str': 'Monocyte Chemoattractant Protein-1'}, {'cui': 'C0008145', 'cui_str': 'Chitinase'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}]",2351.0,0.206763,"Individuals with tubular dysfunction may be less able to compensate to insults than those without, despite similar estimated glomerular filtration rate (eGFR) and albuminuria.","[{'ForeName': 'Alexander L', 'Initials': 'AL', 'LastName': 'Bullen', 'Affiliation': 'Division of Nephrology and Hypertension, Department of Medicine, University of California San Diego, San Diego, California, USA.'}, {'ForeName': 'Ronit', 'Initials': 'R', 'LastName': 'Katz', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Alexandra K', 'Initials': 'AK', 'LastName': 'Lee', 'Affiliation': 'Kidney Health Research Collaborative, Department of Medicine, University of California, San Francisco, California, USA.'}, {'ForeName': 'Cheryl A M', 'Initials': 'CAM', 'LastName': 'Anderson', 'Affiliation': 'Division of Nephrology and Hypertension, Department of Medicine, University of California San Diego, San Diego, California, USA; Division of Preventive Medicine, Department of Family Medicine and Public Health, University of California-San Diego, San Diego, California, USA.'}, {'ForeName': 'Alfred K', 'Initials': 'AK', 'LastName': 'Cheung', 'Affiliation': 'Division of Nephrology & Hypertension, Department of Internal Medicine, University of Utah, Salt Lake City, Utah, USA; Medical Service, Veterans Affairs, Salt Lake City Healthcare System, Salt Lake City, Utah, USA.'}, {'ForeName': 'Pranav S', 'Initials': 'PS', 'LastName': 'Garimella', 'Affiliation': 'Division of Nephrology and Hypertension, Department of Medicine, University of California San Diego, San Diego, California, USA.'}, {'ForeName': 'Vasantha', 'Initials': 'V', 'LastName': 'Jotwani', 'Affiliation': 'Department of Medicine, San Francisco VA Medical Center, San Francisco, California, USA; Department of Epidemiology and Biostatistics, University of California, San Francisco, California, USA.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Haley', 'Affiliation': 'Division of Nephrology and Hypertension, Mayo Clinic, Jacksonville, Florida, USA.'}, {'ForeName': 'Areef', 'Initials': 'A', 'LastName': 'Ishani', 'Affiliation': 'Division of Medicine, Minneapolis Veterans Affairs Health Care System, Minneapolis, Minnesota, USA.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Lash', 'Affiliation': 'Division of Nephrology, Department of Medicine, College of Medicine, University of Illinois at Chicago, Chicago, Illinois, USA.'}, {'ForeName': 'Javier A', 'Initials': 'JA', 'LastName': 'Neyra', 'Affiliation': 'Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky Medical Center, Lexington, Kentucky, USA; Center for Mineral Metabolism and Clinical Research, University of Texas Southwestern, Dallas, Texas, USA.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Punzi', 'Affiliation': 'UT Southwestern Medical Center, Carrollton, Texas, USA.'}, {'ForeName': 'Anjay', 'Initials': 'A', 'LastName': 'Rastogi', 'Affiliation': 'Division of Pulmonary and Critical Care, Department of Medicine, David Geffen School of Medicine, University of California Los Angeles (UCLA), Los Angeles, California, USA.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Riessen', 'Affiliation': 'Medical Service, Veterans Affairs, Salt Lake City Healthcare System, Salt Lake City, Utah, USA.'}, {'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Malhotra', 'Affiliation': 'Division of Nephrology and Hypertension, Department of Medicine, University of California San Diego, San Diego, California, USA.'}, {'ForeName': 'Chirag R', 'Initials': 'CR', 'LastName': 'Parikh', 'Affiliation': 'Department of Medicine, Section of Nephrology, Yale University, New Haven, Connecticut, USA.'}, {'ForeName': 'Michael V', 'Initials': 'MV', 'LastName': 'Rocco', 'Affiliation': 'Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Barry M', 'Initials': 'BM', 'LastName': 'Wall', 'Affiliation': 'Division of Nephrology, Veterans Affairs Medical Center, Memphis, Tennessee, USA.'}, {'ForeName': 'Udayan Y', 'Initials': 'UY', 'LastName': 'Bhatt', 'Affiliation': 'Division of Nephrology, The Ohio State University, Wexner Medical Center, Columbus, Ohio, USA.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Shlipak', 'Affiliation': 'Kidney Health Research Collaborative, Department of Medicine, University of California, San Francisco, California, USA; Department of Medicine, San Francisco VA Medical Center, San Francisco, California, USA.'}, {'ForeName': 'Joachim H', 'Initials': 'JH', 'LastName': 'Ix', 'Affiliation': 'Division of Nephrology and Hypertension, Department of Medicine, University of California San Diego, San Diego, California, USA; Nephrology Section, Veterans Affairs, San Diego Healthcare System, La Jolla, California, USA.'}, {'ForeName': 'Michelle M', 'Initials': 'MM', 'LastName': 'Estrella', 'Affiliation': 'Kidney Health Research Collaborative, Department of Medicine, University of California, San Francisco, California, USA; Department of Medicine, San Francisco VA Medical Center, San Francisco, California, USA. Electronic address: michelle.estrella@ucsf.edu.'}]",Kidney international,['10.1016/j.kint.2019.03.024']
3008,33001536,Patients with highly unstable type 1 diabetes eligible for islet transplantation can be managed with a closed-loop insulin delivery system: A series of N-of-1 randomized controlled trials.,"AIM


To compare the efficacy of the closed-loop Diabeloop for highly unstable diabetes (DBLHU) system with the open-loop predictive low glucose suspend (PLGS) system in patients with highly unstable type 1 diabetes (T1D) who experience acute metabolic events.
METHODS


DBLHU-WP10 was an interventional, controlled, randomized, open-label study that comprised two cycles of N-of-1 trials (2-of-1 trials). Each trial consisted of two crossover 4-week periods of treatment with either DBLHU or PLGS in randomized order. The primary outcome was the percentage of time spent in the 70-180 mg/dL glucose range (time in range [TIR]).
RESULTS


Five out of seven randomized patients completed the aggregated 2-of-1 trials. TIR was significantly higher with DBLHU (73.3% ± 1.7%) compared with PLGS (43.5% ± 1.7%; P < .0001). The percentage of time below 70 mg/dL was significantly lower with DBLHU (0.9% ± 0.4%) versus PLGS (3.7% ± 0.4%; P < .0001). DBLHU was also significantly superior to PLGS in reducing hyperglycaemic excursions and improving almost all other secondary outcomes, including glucose variability and satisfaction score. No adverse event could be related to the experimental treatment.
CONCLUSIONS


DBLHU was superior to PLGS in improving the metabolic control of patients with highly unstable T1D who require an islet or pancreas transplant but who either have a contraindication or refuse to consent.",2020,"DBLHU was also significantly superior to PLGS to reduce hyperglycaemic excursions and to improve almost all other secondary outcomes, including glucose variability and satisfaction score.","['patients with highly unstable T1D, who require an islet or pancreas transplant but who have a contraindication or refuse to consent', 'Patients with highly unstable type 1 diabetes (T1D) who suffer from acute metabolic events despite the best standard medical care are eligible for an islet or pancreas transplant']","['closed-loop DBLHU (Diabeloop for Highly Unstable Diabetes) system versus the open-loop PLGS (predictive low glucose suspend system', 'DBLHU or PLGS', 'PLGS']","['hyperglycaemic excursions', 'glucose variability and satisfaction score', 'percentage of time spent in the 70-180 mg/dL glucose range (time-in-range, TIR', 'TIR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0443343', 'cui_str': 'Unstable status'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0030275', 'cui_str': 'Transplantation of pancreas'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to'}, {'cui': 'C0017095', 'cui_str': 'Trash'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0011854', 'cui_str': 'Type 1 diabetes mellitus'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0496675', 'cui_str': 'Medical care'}]","[{'cui': 'C0443183', 'cui_str': 'Closed loop'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0443343', 'cui_str': 'Unstable status'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0559530', 'cui_str': 'Open loop'}, {'cui': 'C0860801', 'cui_str': 'Glucose low'}, {'cui': 'C0038959', 'cui_str': 'Suspending Agents'}]","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0460094', 'cui_str': 'Within reference range'}, {'cui': 'C0574173', 'cui_str': 'Tigrinya language'}]",7.0,0.0972396,"DBLHU was also significantly superior to PLGS to reduce hyperglycaemic excursions and to improve almost all other secondary outcomes, including glucose variability and satisfaction score.","[{'ForeName': 'Pierre-Yves', 'Initials': 'PY', 'LastName': 'Benhamou', 'Affiliation': 'Department of Endocrinology, Grenoble University Hospital, Grenoble Alpes University, INSERM U1055, LBFA, Grenoble, France.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Lablanche', 'Affiliation': 'Department of Endocrinology, Grenoble University Hospital, Grenoble Alpes University, INSERM U1055, LBFA, Grenoble, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Vambergue', 'Affiliation': 'Department of Endocrinology, Lille University Hospital, Lille, France.'}, {'ForeName': 'Maeva', 'Initials': 'M', 'LastName': 'Doron', 'Affiliation': 'University Grenoble Alpes, CEA, LETI, Grenoble, France.'}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Franc', 'Affiliation': 'CERITD (Center for Study and Research for Improvement of the Treatment of Diabetes), Bioparc-Genopole Evry-Corbeil, Evry, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Charpentier', 'Affiliation': 'CERITD (Center for Study and Research for Improvement of the Treatment of Diabetes), Bioparc-Genopole Evry-Corbeil, Evry, France.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14214']
3009,32998912,Does an emergency access button increase the patients' satisfaction and feeling of safety with the out-of-hours health services? A randomised controlled trial in Denmark.,"OBJECTIVE


To investigate if the option to bypass the telephone queue can increase satisfaction and feeling of safety in callers.
DESIGN


Randomised controlled parallel superiority trial. Data from questionnaire survey.
SETTING


Two out-of-hours (OOH) services in Denmark.
PARTICIPANTS


217 510 citizens who called the OOH services between 4 September 2017 and 30 November 2017.
RANDOMISATION


Two-faze study period: First half with randomisation of participants based on their date of birth; even date randomised to intervention, uneven date randomised to control group. Second half with all participants included in intervention group.
INTERVENTION


Providing randomised callers (intervention group n=146 355) with the option to bypass the telephone waiting line through an emergency access button (EAB), while the rest got the normal service (control group n=71 155). All EAB users were invited to a questionnaire survey as well as random participants who did not use the EAB (of whom approximately 50% did not have the EAB option).
MAIN OUTCOME MEASURES


Satisfaction and feeling of safety in callers.
RESULTS


2208 of 6704 (32.9%) invited callers answered the questionnaire (intervention group n=1415 (users n=621, non-users n=794); control group n=793). The OR for answering in the two categories with highest satisfaction when provided with the EAB option was 1.34 (95% CI 1.07 to 1.68) for satisfaction with the waiting time, 1.21 (95% CI 0.91 to 1.60) for overall satisfaction and 1.46 (95% CI 1.12 to 1.89) for feeling of safety. Approximately 72% (441/621) of EAB users reported that the EAB option increased their feeling of safety with the OOH services 'to a high degree' compared with 25% (197/794) of callers who had the EAB option without using it.
CONCLUSIONS


The EAB can provide fast access to OOH telephone advice in case of severe illness. It favours citizens perceived in most need of urgent healthcare and significantly increases both feeling of safety and patient satisfaction.
TRIAL REGISTRATION DETAILS


NCT02572115 (5 October 2015).",2020,"Approximately 72% (441/621) of EAB users reported that the EAB option increased their feeling of safety with the OOH services 'to a high degree' compared with 25% (197/794) of callers who had the EAB option without using it.
","['Two out-of-hours (OOH) services in Denmark', '217\u2009510 citizens who called the OOH services between 4 September 2017 and 30 November 2017', 'All EAB users were invited to a questionnaire survey as well as random participants who did not use the EAB (of whom approximately 50% did not have the EAB option', '2208 of 6704 (32.9%) invited callers answered the questionnaire (intervention group n=1415 (users n=621, non-users n=794); control group n=793', 'callers']","['option to bypass the telephone waiting line through an emergency access button (EAB), while the rest got the normal service (control group n=71\u2009155', 'EAB']","['Satisfaction and feeling of safety in callers', 'feeling of safety and patient satisfaction', 'overall satisfaction', 'feeling of safety', 'satisfaction and feeling of safety']","[{'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C4517646', 'cui_str': '217'}, {'cui': 'C4517800', 'cui_str': '510'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0453985', 'cui_str': 'Button'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0741847', 'cui_str': 'Bypass'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0453985', 'cui_str': 'Button'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",217510.0,0.146243,"Approximately 72% (441/621) of EAB users reported that the EAB option increased their feeling of safety with the OOH services 'to a high degree' compared with 25% (197/794) of callers who had the EAB option without using it.
","[{'ForeName': 'Jonas Fynboe', 'Initials': 'JF', 'LastName': 'Ebert', 'Affiliation': 'Research Unit for General Practice, Aarhus Universitet Health, Aarhus, Denmark jonasebert@ph.au.dk.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Huibers', 'Affiliation': 'Research Unit for General Practice, Aarhus Universitet, Aarhus, Denmark.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Christensen', 'Affiliation': 'Public Health, Aarhus University, Aarhus C, Denmark.'}, {'ForeName': 'Helle', 'Initials': 'H', 'LastName': 'Collatz Christensen', 'Affiliation': 'Copenhagen Emergency Medical Services, Copenhagen, Denmark.'}, {'ForeName': 'Morten Bondo', 'Initials': 'MB', 'LastName': 'Christensen', 'Affiliation': 'Research Unit for General Practice, Aarhus Universitet, Aarhus, Denmark.'}]",BMJ open,['10.1136/bmjopen-2019-030267']
3010,32998920,"Protocol of DEXPED trial: efficacy of intravenous dexamethasone, administered at the time of analgesic blocking of the lower limb, on postoperative pain in children: a randomised, placebo-controlled, double-blind trial.","INTRODUCTION


Dexamethasone is a drug used to prolong the postoperative analgesia in children after peripheral nerve blockade, although the dose usually used (0.2 mg/kg) has not been studied yet. This study is a monocentric, prospective, randomised, placebo-controlled, double-blinded study in a university hospital in France. The primary objective of the study is to evaluate the efficacy of 0.2 mg/kg intravenous dexamethasone on early postoperative pain in children aged 6-15 years, who require a lower limb peripheral nerve block following general anaesthesia.
METHODS AND ANALYSIS


Eighty children, aged 6-15 years, undergoing surgery for which peripheral nerve lower limb blockade with ropivacaine following general anaesthesia are included. The inclusion criteria are: children aged 6-15 years, with American Society of Anaesthesiologists physical status I or II and scheduled for surgery requiring a peripheral block of the lower limb for analgesic purposes, with a preoperative anaesthetic evaluation between 90 and 2 days before the surgery, with informed consent from legal representatives. General anaesthesia is performed. The patient receives, according to his group, either 0.2 mg/kg of dexamethasone intravenously at the start of anaesthetic induction or the same volume of placebo. Then, the peripheral block of the lower limb is performed with ropivacaine. The primary outcome is the total doses of opioid administered (in mg/kg of morphine equivalent) within 24 hours postoperatively. The secondary objectives are the evaluation of the effect of a single-dose intravenous dexamethasone at the time of anaesthetic induction, on the following parameters: onset of postoperative pain, duration of motor block, postoperative nausea and vomiting within 24 hours.
ETHICS AND DISSEMINATION


This study is conducted according to the principles of the Declaration of Helsinki and has been approved by the French national ethics committee and the National Drug Safety Agency. Findings of this study will be widely disseminated through conference presentations, reports, factsheets and academic publications.
TRIAL REGISTRATION NUMBER


NCT03618173.",2020,This study is conducted according to the principles of the Declaration of Helsinki and has been approved by the French national ethics committee and the National Drug Safety Agency.,"['university hospital in France', 'Eighty children, aged 6-15 years, undergoing surgery for which peripheral nerve lower limb blockade with ropivacaine following general anaesthesia are included', 'children aged 6-15 years, who require a lower limb peripheral nerve block following general anaesthesia', 'children aged 6-15 years, with American Society of Anaesthesiologists physical status I or II and scheduled for surgery requiring a peripheral block of the lower limb for analgesic purposes, with a preoperative anaesthetic evaluation between 90 and 2 days before the surgery, with informed consent from legal representatives', 'children']","['dexamethasone', 'Dexamethasone', 'placebo', 'ropivacaine']","['total doses of opioid', 'early postoperative pain', 'postoperative pain, duration of motor block, postoperative nausea and vomiting']","[{'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0031119', 'cui_str': 'Peripheral nerve structure'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0198807', 'cui_str': 'Peripheral block anesthesia'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1285529', 'cui_str': 'Purpose'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C1301860', 'cui_str': 'Legal'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}]",80.0,0.487174,This study is conducted according to the principles of the Declaration of Helsinki and has been approved by the French national ethics committee and the National Drug Safety Agency.,"[{'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Vautrin', 'Affiliation': ""Département d'Anesthesie-Réanimation, Université de Lorraine, Nancy, Lorraine, France nicolas_vautrin@hotmail.fr.""}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Thilly', 'Affiliation': ""Plateforme d'Aide à la Recherche Clinique, Université de Lorraine, Nancy, Lorraine, France.""}, {'ForeName': 'Yohann', 'Initials': 'Y', 'LastName': 'Bernard', 'Affiliation': 'Département Méthodologie Promotion Investigation, Université de Lorraine, Nancy, Lorraine, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Wurtz', 'Affiliation': ""Département d'Anesthesie-Réanimation, Université de Lorraine, Nancy, Lorraine, France.""}, {'ForeName': 'Claude', 'Initials': 'C', 'LastName': 'Meistelman', 'Affiliation': ""Département d'Anesthesie-Réanimation, Université de Lorraine, Nancy, Lorraine, France.""}]",BMJ open,['10.1136/bmjopen-2020-036863']
3011,32998921,"Dancing to improve balance control, cognitive-motor functions and quality of life after stroke: a study protocol for a randomised controlled trial.","INTRODUCTION


Dance is an intrinsically motivating activity that includes social interaction, stimulation through music, the pleasure of moving despite pathology-induced motor limitations, and it also has good perceived benefits among participants. Feeling pleasure while moving is essential to finding the motivation to engage in a rehabilitation programme. It is, therefore, urgent to provide persons in a poststroke situation with motivating physical activity opportunities. Very few studies have examined dance in a stroke context, while it is highly adapted and effective for other chronic conditions.Our primary objective is to assess the effects of dance programme on patients' balance control after stroke. Our secondary objective is to investigate the effects of dance on cognitive function, strength, coordination, functional status, balance confidence, quality of life, motivation and adherence. Our hypothesis is that dance increases balance and motor capacities, and improves poststroke quality of life, adherence and motivation.
METHODS AND ANALYSIS


Forty-eight subjects with stroke in subacute phase will be randomised into two groups: (1) intervention (dance and standard rehabilitation) and (2) control (standard rehabilitation). Before intervention, stroke severity, cognitive abilities and motor capacities will be assessed. Two baseline tests will be planned to evaluate the stability of individuals. Participants will attend a weekly 60-min dance class for 6 weeks. Cognitive and motor functions (balance, lower-limbs strength, coordination and motor level), quality of life (Stroke-Specific Quality of Life Scale) will be measured at weeks 4 and 6 in both groups. Participant satisfaction with regard to dance will be tested, as well as adherence and adverse effects.
ETHICS AND DISSEMINATION


Ethics approval has been granted by the Swiss Ethics Committee of the CER Vaud (2019-01467). Outcomes will be disseminated through publication in peer-reviewed journals and presentations at conferences.
TRIAL REGISTRATION NUMBER


NCT04120467.",2020,"Cognitive and motor functions (balance, lower-limbs strength, coordination and motor level), quality of life (Stroke-Specific Quality of Life Scale) will be measured at weeks 4 and 6 in both groups.","[""patients' balance control after stroke"", 'Forty-eight subjects with stroke in subacute phase']","['intervention (dance and standard rehabilitation) and (2) control (standard rehabilitation', 'dance programme']","['Cognitive and motor functions (balance, lower-limbs strength, coordination and motor level), quality of life (Stroke-Specific Quality of Life Scale', 'stroke severity, cognitive abilities and motor capacities', 'balance control, cognitive-motor functions and quality of life', 'poststroke quality of life, adherence and motivation', 'cognitive function, strength, coordination, functional status, balance confidence, quality of life, motivation and adherence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0205365', 'cui_str': 'Subacute'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0010963', 'cui_str': 'Dance'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0242414', 'cui_str': 'Coordination'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}]",48.0,0.0846768,"Cognitive and motor functions (balance, lower-limbs strength, coordination and motor level), quality of life (Stroke-Specific Quality of Life Scale) will be measured at weeks 4 and 6 in both groups.","[{'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Morice', 'Affiliation': 'Neurorehabilitation, Institution de Lavigny, Lavigny, Vaud, Switzerland.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Moncharmont', 'Affiliation': 'Neurorehabilitation, Institution de Lavigny, Lavigny, Vaud, Switzerland.'}, {'ForeName': 'Clémentine', 'Initials': 'C', 'LastName': 'Jenny', 'Affiliation': 'Neurorehabilitation, Institution de Lavigny, Lavigny, Vaud, Switzerland.'}, {'ForeName': 'Anne-Violette', 'Initials': 'AV', 'LastName': 'Bruyneel', 'Affiliation': 'Physiotherapy Department, Geneva School of Health Sciences, HES-SO University of Applied Sciences and Arts Western Switzerland, Geneva, Switzerland anne-violette.bruyneel@hesge.ch.'}]",BMJ open,['10.1136/bmjopen-2020-037039']
3012,33000517,Magnification loupes influence on neck and trunk flexion of dental hygienists while scaling-A pilot study.,"OBJECTIVE


Work-related musculoskeletal disorders (MSDs) are common in the dental hygiene profession. Awkward postures contribute to MSDs and magnification loupes have been suggested to reduce this risk factor and minimize MSDs.
METHODS


After IRB approval, 24 hygienists were enrolled in the study: twelve hygienists wearing loupes with a standard manufacturer determined declination angle (control) and 12 hygienists wearing loupes with a custom measured declination angle (experimental). To measure changes in neck and trunk flexion, accelerometers were placed on the occipital region of head, cervical vertebrae C5, and thoracic vertebrae T5 and baseline posture was recorded. Typodonts with artificial calculus simulated the oral environment. Participants were randomly assigned to wear their designated loupes during the first or second trial of the experiment and scaled in each quadrant (UR, LR, UL, LL) of the mouth for two minutes. Participants completed the scaling task twice: in the loupes and no loupes condition in a counterbalanced order. Three-way mixed design ANOVA was used to determine posture differences in neck and trunk posture.
RESULTS


Those wearing custom loupes (M = 16.52, SD = 6.40) had significantly less trunk flexion while scaling compared to hygienists wearing standard loupes (M = 22.27, SD = 6.40), F(1, 22) = 7.14, P = .01. Neck flexion was not significantly affected while scaling between loupes vs no loupes or loupes type condition, (P's > .05).
CONCLUSION


Posture was partially impacted by loupes type. Custom loupes resulted in less trunk flexion. Neck flexion was not affected by either loupes type.",2020,"Neck flexion was not significantly affected while scaling between loupes v. no loupes or loupes type condition, (p's >.05).
",['24 hygienists were enrolled in the study: twelve hygienists wearing loupes with a standard manufacturer determined declination angle (control) and 12 hygienists wearing loupes with a custom measured declination angle (experimental'],[],"['Neck flexion', 'trunk flexion']","[{'cui': 'C0011369', 'cui_str': 'Dental hygienist'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0549181', 'cui_str': 'Loupes'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0162343', 'cui_str': 'Customs'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",[],"[{'cui': 'C0445088', 'cui_str': 'Neck flexion'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}]",24.0,0.066081,"Neck flexion was not significantly affected while scaling between loupes v. no loupes or loupes type condition, (p's >.05).
","[{'ForeName': 'Emily A', 'Initials': 'EA', 'LastName': 'Ludwig', 'Affiliation': 'School of Dental Hygiene, Old Dominion University, Granada, Spain.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Tolle', 'Affiliation': 'School of Dental Hygiene, Old Dominion University, Granada, Spain.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Jenkins', 'Affiliation': 'School of Rehabilitation Sciences, Old Dominion University, Granada, Spain.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Russell', 'Affiliation': 'School of Rehabilitation Sciences, Old Dominion University, Granada, Spain.'}]",International journal of dental hygiene,['10.1111/idh.12470']
3013,32997816,Clinical and patient-centered outcomes using two types of subepithelial connective tissue grafts: A split-mouth randomized clinical trial.,"BACKGROUND


This split-mouth randomized clinical trial compared two different types of subepithelial connective tissue grafts (SCTG) considering clinical parameters and patient-centered outcomes in patients with bilateral recession type 1 multiple gingival recessions after 6 months postoperatively.
METHODS


A total of 21 patients were surgically treated with coronally advanced flap (CAF) associated with SCTG harvested by: double blade scalpel (DBS) and de-epithelialized (DE) SCTG. Periodontal clinical parameters and esthetics were evaluated by a calibrated periodontist at baseline and after 6 months. Patient-centered outcomes related to pain/discomfort and esthetics were assessed with visual analogue scale after 7 days and 6 months, respectively.
RESULTS


All clinical parameters, with the exception of probing depth, demonstrated differences in intragroup evaluation, comparing baseline to 6-month evaluation (P <0.05). Both groups presented reduction of recession depth and recession width and gain of keratinized tissue thickness, keratinized tissue width, and clinical attachment level (P <0.05). Intergroup comparison (DBS × DE) demonstrated no significant differences considering clinical parameters and periods. Both techniques improved esthetics evaluated by patients, without a difference between groups in patients and professional analysis. However, DBS group presented inferior pain/discomfort compared with DE (P <0.05).
CONCLUSION


DBS and DE associated with CAF presented satisfactory clinical outcomes. However, DBS presented inferior morbidity, an important fact for decision-making process.",2020,"Both groups presented reduction of RD and RW and gain of KTT, KTW and CAL (p<0.05).","['patients with bilateral RT 1 multiple gingival recessions after 6 months postoperatively', '21 patients were surgically treated with coronally advanced flap (CAF) associated with SCTG harvested by']","['double blade scalpel (DBS) and de-epithelized (DE) SCTG', 'subepithelial connective tissue grafts (SCTG', 'subepithelial connective tissue grafts', 'DBS']","['inferior morbidity', 'inferior pain/discomfort', 'Visual Analogue Scale (VAS', 'pain/discomfort and aesthetics', 'reduction of RD and RW and gain of KTT, KTW and CAL (p<0.05']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0017572', 'cui_str': 'Gingival recession'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0009780', 'cui_str': 'Connective tissue'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C2948008', 'cui_str': 'Blade'}, {'cui': 'C0392220', 'cui_str': 'Scalpel'}, {'cui': 'C0009780', 'cui_str': 'Connective tissue'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}]","[{'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0439259', 'cui_str': 'kcal'}]",21.0,0.110217,"Both groups presented reduction of RD and RW and gain of KTT, KTW and CAL (p<0.05).","[{'ForeName': 'Mariana Schutzer Ragghianti', 'Initials': 'MSR', 'LastName': 'Zangrando', 'Affiliation': 'Department of Periodontics, Bauru School of Dentistry, University of São Paulo, Bauru, São Paulo, Brazil.'}, {'ForeName': 'Ricardo Rabelo', 'Initials': 'RR', 'LastName': 'Eustachio', 'Affiliation': 'Department of Periodontics, Bauru School of Dentistry, University of São Paulo, Bauru, São Paulo, Brazil.'}, {'ForeName': 'Maria Lúcia Rubo', 'Initials': 'MLR', 'LastName': 'de Rezende', 'Affiliation': 'Department of Periodontics, Bauru School of Dentistry, University of São Paulo, Bauru, São Paulo, Brazil.'}, {'ForeName': 'Adriana Campos Passanezi', 'Initials': 'ACP', 'LastName': ""Sant'ana"", 'Affiliation': 'Department of Periodontics, Bauru School of Dentistry, University of São Paulo, Bauru, São Paulo, Brazil.'}, {'ForeName': 'Carla Andreotti', 'Initials': 'CA', 'LastName': 'Damante', 'Affiliation': 'Department of Periodontics, Bauru School of Dentistry, University of São Paulo, Bauru, São Paulo, Brazil.'}, {'ForeName': 'Sebastião Luiz Aguiar', 'Initials': 'SLA', 'LastName': 'Greghi', 'Affiliation': 'Department of Periodontics, Bauru School of Dentistry, University of São Paulo, Bauru, São Paulo, Brazil.'}]",Journal of periodontology,['10.1002/JPER.19-0646']
3014,32997825,VEGFR2 and VEGFA polymorphisms are not associated with an inferior prognosis in Caucasian patients with aggressive B-cell lymphoma.,"PURPOSE


Previous published data showed an impact of single-nucleotide polymorphisms in the VEGF A and VEGFR2 genes on the survival of patients with various malignancies, among others diffuse large B-cell lymphoma (DLBCL).
PATIENTS AND METHODS


We investigated the role of four VEGF-A and two VEGFR-2 gene polymorphisms on the outcome of 273 patients with diffuse large B-cell lymphoma who were treated with R-CHOP within a prospective, randomized trial of the German High-Grade Non-Hodgkin Lymphoma Study Group (DSHNHL). The genomic DNA samples were analyzed using commercial DNA Probes (Applied Biosystems, USA) to detect single-nucleotide polymorphisms in the VEGF A rs699947, rs1570360, rs2010963, rs3025039 and rs1870377, and rs2305948 in the VEGFR2 receptor. Hundred healthy blood donors served as a control.
RESULTS


There was no difference between the SNP allele frequencies in lymphoma patients compared to the control group for all investigated SNPs. None of the investigated SNPs was significantly associated with EFS or OS. After adjusting for the International Prognostic Index risk factors in a multivariate analysis, these results could be confirmed.
CONCLUSION


Single-nucleotide polymorphisms of the VEGF and VEGFR2 were not associated with a worse outcome in Caucasian patients with DLBCL.",2020,"CONCLUSION


Single nucleotide polymorphisms of the VEGF and VEGFR2 were not associated with a worse outcome in Caucasian patients with DLBCL.","['273 patients with diffuse large B-cell lymphoma who were treated with R-CHOP within a prospective, randomized trial of the German High-Grade Non-Hodgkin Lymphoma Study Group (DSHNHL', 'Hundred healthy blood donors served as a control', 'Caucasian patients with aggressive B-cell lymphoma', 'patients with various malignancies, among others diffuse large B-cell lymphoma (DLBCL', 'Caucasian patients with DLBCL']",['VEGF-A and two VEGFR-2 gene polymorphisms'],['SNP allele frequencies'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0079744', 'cui_str': 'Malignant lymphoma, large B-cell, diffuse'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0055598', 'cui_str': 'CHOP protocol'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0024305', 'cui_str': 'Malignant lymphoma, non-Hodgkin'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0005795', 'cui_str': 'Blood donor'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0079731', 'cui_str': 'B-cell lymphoma (clinical)'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0378796', 'cui_str': 'KDR Tyrosine Kinase'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0032529', 'cui_str': 'Genetic polymorphism'}]","[{'cui': 'C0752046', 'cui_str': 'Single Nucleotide Polymorphism'}, {'cui': 'C0017270', 'cui_str': 'Gene frequency'}]",273.0,0.0321369,"CONCLUSION


Single nucleotide polymorphisms of the VEGF and VEGFR2 were not associated with a worse outcome in Caucasian patients with DLBCL.","[{'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'Kaddu-Mulindwa', 'Affiliation': 'Department of Hematology and Oncology, Saarland University Medical School, Homburg, Germany.'}, {'ForeName': 'Maciej', 'Initials': 'M', 'LastName': 'Rosolowski', 'Affiliation': 'Institute for Medical Informatics, Statistics and Epidemiology (IMISE), University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Marita', 'Initials': 'M', 'LastName': 'Ziepert', 'Affiliation': 'Institute for Medical Informatics, Statistics and Epidemiology (IMISE), University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Evi', 'Initials': 'E', 'LastName': 'Regitz', 'Affiliation': 'Department of Hematology and Oncology, Saarland University Medical School, Homburg, Germany.'}, {'ForeName': 'Gunter', 'Initials': 'G', 'LastName': 'Assmann', 'Affiliation': 'Department of Hematology and Oncology, Saarland University Medical School, Homburg, Germany.'}, {'ForeName': 'Moritz', 'Initials': 'M', 'LastName': 'Bewarder', 'Affiliation': 'Department of Hematology and Oncology, Saarland University Medical School, Homburg, Germany.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Held', 'Affiliation': 'Department of Hematology and Oncology, Saarland University Medical School, Homburg, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Pfreundschuh', 'Affiliation': 'Department of Hematology and Oncology, Saarland University Medical School, Homburg, Germany.'}, {'ForeName': 'Jörg Thomas', 'Initials': 'JT', 'LastName': 'Bittenbring', 'Affiliation': 'Department of Hematology and Oncology, Saarland University Medical School, Homburg, Germany.'}]",European journal of haematology,['10.1111/ejh.13526']
3015,33002436,"Trastuzumab emtansine plus atezolizumab versus trastuzumab emtansine plus placebo in previously treated, HER2-positive advanced breast cancer (KATE2): a phase 2, multicentre, randomised, double-blind trial.","BACKGROUND


HER2-positive metastatic breast cancer is incurable and new treatments are needed. Addition of atezolizumab to trastuzumab emtansine might potentiate anticancer immunity and enhance the HER2-targeted cytotoxic activity of trastuzumab emtansine. We aimed to test this combination in HER2-positive advanced breast cancer that had progressed after previous treatment with trastuzumab and a taxane.
METHODS


The KATE2 study is a randomised, double-blind, placebo-controlled, phase 2 study at 68 centres from nine countries across Asia, Australia, North America, and western Europe. Eligible patients were adults (aged ≥18 years) with an Eastern Cooperative Oncology Group performance status of 0 or 1 and centrally confirmed, measurable, HER2-positive advanced breast cancer previously treated with trastuzumab and a taxane. Patients were randomly assigned (2:1) either trastuzumab emtansine (3·6 mg/kg of bodyweight) plus atezolizumab (1200 mg) or trastuzumab emtansine plus placebo; all study drugs were administered by intravenous infusion every 3 weeks. Randomisation was done via an interactive voice and web response system using a permuted block scheme (block size of six) and was stratified by PD-L1 status, world region, and liver metastases. Patients, investigators, and study team members were masked to treatment allocation. The primary endpoint was investigator-assessed progression-free survival in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, NCT02924883, and the study has been completed.
FINDINGS


Between Sept 26, 2016, and Aug 7, 2017, 330 patients were screened for the study, of whom 202 were randomly allocated either atezolizumab (n=133) or placebo (n=69). At the recommendation of the independent data monitoring committee, treatment assignment was unmasked on Dec 11, 2017, due to futility and the numerically higher frequency of adverse events among patients assigned atezolizumab. This date was set as the clinical cutoff for the primary analysis. Median follow-up was 8·5 months (IQR 6·1-11·5) for patients assigned atezolizumab and 8·4 months (5·3-11·1) for those assigned placebo. Median progression-free survival was 8·2 months (95% CI 5·8-10·7) for patients assigned atezolizumab versus 6·8 months (4·0-11·1) for those assigned placebo (stratified hazard ratio 0·82, 95% CI 0·55-1·23; p=0·33). The most common grade 3 or worse adverse events were thrombocytopenia (17 [13%] among 132 patients who received atezolizumab vs three [4%] among 68 who received placebo), increased aspartate aminotransferase (11 [8%] vs two [3%]), anaemia (seven [5%] vs 0), neutropenia (six [5%] vs three [4%]), and increased alanine aminotransferase (six [5%] vs two [3%]). Serious adverse events occurred in 43 (33%) of 132 patients who received atezolizumab and 13 (19%) of 68 patients who received placebo. One patient who received atezolizumab died due to a treatment-related adverse event (haemophagocytic syndrome).
INTERPRETATION


Addition of atezolizumab to trastuzumab emtansine did not show a clinically meaningful improvement in progression-free survival and was associated with more adverse events. Further study of trastuzumab emtansine plus atezolizumab is warranted in a subpopulation of patients with PD-L1-positive, HER2-positive advanced breast cancer.
FUNDING


F Hoffman-La Roche.",2020,"Median progression-free survival was 8·2 months (95% CI 5·8-10·7) for patients assigned atezolizumab versus 6·8 months (4·0-11·1) for those assigned placebo (stratified hazard ratio 0·82, 95% CI 0·55-1·23;","['Eligible patients were adults (aged ≥18 years) with an Eastern Cooperative Oncology Group performance status of 0 or 1 and centrally confirmed, measurable, HER2-positive advanced breast cancer previously treated with', 'HER2-positive advanced breast cancer that had progressed after previous treatment with', 'patients with PD-L1-positive, HER2-positive advanced breast cancer', 'Between Sept 26, 2016, and Aug 7, 2017, 330 patients were screened for the study, of whom 202', 'previously treated, HER2-positive advanced breast cancer (KATE2', '68 centres from nine countries across Asia, Australia, North America, and western Europe']","['trastuzumab and a taxane', 'trastuzumab emtansine (3·6 mg/kg of bodyweight) plus atezolizumab', 'Trastuzumab emtansine plus atezolizumab versus trastuzumab emtansine plus placebo', 'trastuzumab emtansine plus placebo', 'placebo', 'trastuzumab emtansine plus atezolizumab', 'atezolizumab']","['thrombocytopenia', 'aspartate aminotransferase', 'Serious adverse events', 'alanine aminotransferase', 'investigator-assessed progression-free survival', 'neutropenia', 'anaemia', 'progression-free survival', 'Median progression-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C4517719', 'cui_str': '330'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0043129', 'cui_str': 'West European country'}]","[{'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0215136', 'cui_str': 'taxane'}, {'cui': 'C2935436', 'cui_str': 'ado-trastuzumab emtansine'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",330.0,0.76858,"Median progression-free survival was 8·2 months (95% CI 5·8-10·7) for patients assigned atezolizumab versus 6·8 months (4·0-11·1) for those assigned placebo (stratified hazard ratio 0·82, 95% CI 0·55-1·23;","[{'ForeName': 'Leisha A', 'Initials': 'LA', 'LastName': 'Emens', 'Affiliation': 'University of Pittsburgh Medical Center, Hillman Cancer Center, Pittsburgh, PA, USA. Electronic address: emensla@upmc.edu.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Esteva', 'Affiliation': 'Perlmutter Cancer Center at New York University Langone Health, New York, NY, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Beresford', 'Affiliation': 'Royal United Hospital, Bath, UK.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Saura', 'Affiliation': ""Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona, Spain.""}, {'ForeName': 'Michelino', 'Initials': 'M', 'LastName': 'De Laurentiis', 'Affiliation': 'Istituto di Ricovero e Cura a Carattere Scientifico Istituto Nazionale Tumori Fondazione Pascale, Naples, Italy.'}, {'ForeName': 'Sung-Bae', 'Initials': 'SB', 'LastName': 'Kim', 'Affiliation': 'Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Seock-Ah', 'Initials': 'SA', 'LastName': 'Im', 'Affiliation': 'Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Yifan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Roche (China) Holding, Shanghai, China.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Salgado', 'Affiliation': 'Department of Pathology, Gasthuis Zusters Antwerpen-Ziekenhuis Netwerk Antwerpen Hospitals, Antwerp, Belgium.'}, {'ForeName': 'Aruna', 'Initials': 'A', 'LastName': 'Mani', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Jigna', 'Initials': 'J', 'LastName': 'Shah', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Lambertini', 'Affiliation': 'F Hoffmann-La Roche, Basel, Switzerland.'}, {'ForeName': 'Haiying', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Sanne L', 'Initials': 'SL', 'LastName': 'de Haas', 'Affiliation': 'F Hoffmann-La Roche, Basel, Switzerland.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Patre', 'Affiliation': 'F Hoffmann-La Roche, Basel, Switzerland.'}, {'ForeName': 'Sherene', 'Initials': 'S', 'LastName': 'Loi', 'Affiliation': 'Division of Research, Peter MacCallum Cancer Center, Melbourne, VIC, Australia. Electronic address: sherene.loi@petermac.org.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30465-4']
3016,33002437,"Adjuvant radiotherapy versus early salvage radiotherapy following radical prostatectomy (TROG 08.03/ANZUP RAVES): a randomised, controlled, phase 3, non-inferiority trial.","BACKGROUND


Adjuvant radiotherapy has been shown to halve the risk of biochemical progression for patients with high-risk disease after radical prostatectomy. Early salvage radiotherapy could result in similar biochemical control with lower treatment toxicity. We aimed to compare biochemical progression between patients given adjuvant radiotherapy and those given salvage radiotherapy.
METHODS


We did a phase 3, randomised, controlled, non-inferiority trial across 32 oncology centres in Australia and New Zealand. Eligible patients were aged at least 18 years and had undergone a radical prostatectomy for adenocarcinoma of the prostate with pathological staging showing high-risk features defined as positive surgical margins, extraprostatic extension, or seminal vesicle invasion; had an Eastern Cooperative Oncology Group performance status of 0-1, and had a postoperative prostate-specific antigen (PSA) concentration of 0·10 ng/mL or less. Patients were randomly assigned (1:1) using a minimisation technique via an internet-based, independently generated allocation to either adjuvant radiotherapy within 6 months of radical prostatectomy or early salvage radiotherapy triggered by a PSA of 0·20 ng/mL or more. Allocation sequence was concealed from investigators and patients, but treatment assignment for individual randomisations was not masked. Patients were stratified by radiotherapy centre, preoperative PSA, Gleason score, surgical margin status, and seminal vesicle invasion status. Radiotherapy in both groups was 64 Gy in 32 fractions to the prostate bed without androgen deprivation therapy with real-time review of plan quality on all cases before treatment. The primary endpoint was freedom from biochemical progression. Salvage radiotherapy would be deemed non-inferior to adjuvant radiotherapy if freedom from biochemical progression at 5 years was within 10% of that for adjuvant radiotherapy with a hazard ratio (HR) for salvage radiotherapy versus adjuvant radiotherapy of 1·48. The primary analysis was done on an intention-to-treat basis. This study is registered with ClinicalTrials.gov, NCT00860652.
FINDINGS


Between March 27, 2009, and Dec 31, 2015, 333 patients were randomly assigned (166 to adjuvant radiotherapy; 167 to salvage radiotherapy). Median follow-up was 6·1 years (IQR 4·3-7·5). An independent data monitoring committee recommended premature closure of enrolment because of unexpectedly low event rates. 84 (50%) patients in the salvage radiotherapy group had radiotherapy triggered by a PSA of 0·20 ng/mL or more. 5-year freedom from biochemical progression was 86% (95% CI 81-92) in the adjuvant radiotherapy group versus 87% (82-93) in the salvage radiotherapy group (stratified HR 1·12, 95% CI 0·65-1·90; p non-inferiority =0·15). The grade 2 or worse genitourinary toxicity rate was lower in the salvage radiotherapy group (90 [54%] of 167) than in the adjuvant radiotherapy group (116 [70%] of 166). The grade 2 or worse gastrointestinal toxicity rate was similar between the salvage radiotherapy group (16 [10%]) and the adjuvant radiotherapy group (24 [14%]).
INTERPRETATION


Salvage radiotherapy did not meet trial specified criteria for non-inferiority. However, these data support the use of salvage radiotherapy as it results in similar biochemical control to adjuvant radiotherapy, spares around half of men from pelvic radiation, and is associated with significantly lower genitourinary toxicity.
FUNDING


New Zealand Health Research Council, Australian National Health Medical Research Council, Cancer Council Victoria, Cancer Council NSW, Auckland Hospital Charitable Trust, Trans-Tasman Radiation Oncology Group Seed Funding, Cancer Research Trust New Zealand, Royal Australian and New Zealand College of Radiologists, Cancer Institute NSW, Prostate Cancer Foundation Australia, and Cancer Australia.",2020,Salvage radiotherapy would be deemed non-inferior to adjuvant radiotherapy if freedom from biochemical progression at 5 years was within 10% of that for adjuvant radiotherapy with a hazard ratio (HR) for salvage radiotherapy versus adjuvant radiotherapy of 1·48.,"['32 oncology centres in Australia and New Zealand', 'patients with high-risk disease after radical prostatectomy', 'patients given', 'Between March 27, 2009, and Dec 31, 2015, 333 patients were randomly assigned (166 to', 'Eligible patients were aged at least 18 years and had undergone a radical prostatectomy for adenocarcinoma of the prostate with pathological staging showing high-risk features defined as positive surgical margins, extraprostatic extension, or seminal vesicle invasion; had an Eastern Cooperative Oncology Group performance status of 0-1, and had a postoperative prostate-specific antigen (PSA) concentration of 0·10 ng/mL or less']","['Adjuvant radiotherapy versus early salvage radiotherapy', 'Salvage radiotherapy', 'adjuvant radiotherapy', 'minimisation technique via an internet-based, independently generated allocation to either adjuvant radiotherapy within 6 months of radical prostatectomy or early salvage radiotherapy triggered by a PSA of 0·20 ng/mL or more', 'adjuvant radiotherapy; 167 to salvage radiotherapy', 'adjuvant radiotherapy and those given salvage radiotherapy', 'Radiotherapy', 'radical prostatectomy (TROG 08.03/ANZUP RAVES', 'salvage radiotherapy', 'radiotherapy']","['grade 2 or worse gastrointestinal toxicity rate', 'freedom from biochemical progression', 'grade 2 or worse genitourinary toxicity rate']","[{'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C4517724', 'cui_str': '333'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C5191361', 'cui_str': '166'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0007112', 'cui_str': 'Adenocarcinoma of prostate'}, {'cui': 'C0443276', 'cui_str': 'Pathological staging'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C1709603', 'cui_str': 'Positive Surgical Margins'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0036628', 'cui_str': 'Seminal vesicle structure'}, {'cui': 'C1269955', 'cui_str': 'Tumour invasion'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}]","[{'cui': 'C0242939', 'cui_str': 'Adjuvant Radiotherapy'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0085405', 'cui_str': 'Salvage therapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C4517595', 'cui_str': '167'}, {'cui': 'C1947971', 'cui_str': 'Give'}]","[{'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C1142499', 'cui_str': 'Gastrointestinal toxicity'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0042066', 'cui_str': 'Structure of genitourinary system'}, {'cui': 'C0040539', 'cui_str': 'TO'}]",333.0,0.349874,Salvage radiotherapy would be deemed non-inferior to adjuvant radiotherapy if freedom from biochemical progression at 5 years was within 10% of that for adjuvant radiotherapy with a hazard ratio (HR) for salvage radiotherapy versus adjuvant radiotherapy of 1·48.,"[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Kneebone', 'Affiliation': 'Department of Radiation Oncology, Royal North Shore Hospital, Sydney, NSW, Australia; Sydney Medical School, University of Sydney, Sydney, NSW, Australia. Electronic address: andrew.kneebone@health.nsw.gov.au.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Fraser-Browne', 'Affiliation': 'Auckland Hospital, Auckland, New Zealand.'}, {'ForeName': 'Gillian M', 'Initials': 'GM', 'LastName': 'Duchesne', 'Affiliation': 'University of Melbourne, Melbourne, VIC, Australia; Department of Radiation Oncology, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Fisher', 'Affiliation': 'Centre for Biostatistics and Clinical Trials, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Frydenberg', 'Affiliation': 'Monash University, Melbourne, VIC, Australia; Cabrini Medical Centre, Melbourne, VIC, Australia.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Herschtal', 'Affiliation': 'Centre for Biostatistics and Clinical Trials, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia.'}, {'ForeName': 'Scott G', 'Initials': 'SG', 'LastName': 'Williams', 'Affiliation': 'University of Melbourne, Melbourne, VIC, Australia; Department of Radiation Oncology, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Brown', 'Affiliation': 'National Health and Medical Research Council, Clinical Trials Centre, University of Sydney, Camperdown, NSW, Australia.'}, {'ForeName': 'Warick', 'Initials': 'W', 'LastName': 'Delprado', 'Affiliation': 'Douglass Hanly Moir Pathology, Sydney, NSW, Australia; University of Notre Dame Australia, Sydney, NSW, Australia; Macquarie University, Sydney, NSW, Australia.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Haworth', 'Affiliation': 'School of Physics, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Joseph', 'Affiliation': 'University of Western Australia, Perth, WA, Australia; Edith Cowan University, Perth, WA, Australia; Genesis Cancer Care, Perth, WA, Australia; 5D Clinics, Perth, WA, Australia.'}, {'ForeName': 'Jarad M', 'Initials': 'JM', 'LastName': 'Martin', 'Affiliation': 'Calvary Mater Newcastle Hospital, Newcastle, NSW, Australia; School of Medicine and Public Health, University of Newcastle, Newcastle, NSW, Australia.'}, {'ForeName': 'John H L', 'Initials': 'JHL', 'LastName': 'Matthews', 'Affiliation': 'Auckland Hospital, Auckland, New Zealand.'}, {'ForeName': 'Jeremy L', 'Initials': 'JL', 'LastName': 'Millar', 'Affiliation': 'Monash University, Melbourne, VIC, Australia; Alfred Health Radiation Oncology, Melbourne, VIC, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Sidhom', 'Affiliation': 'Cancer Therapy Centre, Liverpool Hospital, Sydney, NSW, Australia; University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Spry', 'Affiliation': 'Edith Cowan University, Perth, WA, Australia; Sir Charles Gairdner Hospital, Perth, WA, Australia; Genesis Cancer Care, Perth, WA, Australia.'}, {'ForeName': 'Colin I', 'Initials': 'CI', 'LastName': 'Tang', 'Affiliation': 'Edith Cowan University, Perth, WA, Australia; Sir Charles Gairdner Hospital, Perth, WA, Australia.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Turner', 'Affiliation': 'Sydney Medical School, University of Sydney, Sydney, NSW, Australia; Crown Princess Mary Cancer Centre, Westmead, NSW, Australia.'}, {'ForeName': 'Kirsty L', 'Initials': 'KL', 'LastName': 'Wiltshire', 'Affiliation': 'Department of Radiation Oncology, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia.'}, {'ForeName': 'Henry H', 'Initials': 'HH', 'LastName': 'Woo', 'Affiliation': 'Sydney Medical School, University of Sydney, Sydney, NSW, Australia; Department of Urology, Sydney Adventist Hospital, Wahroonga, NSW Australia.'}, {'ForeName': 'Ian D', 'Initials': 'ID', 'LastName': 'Davis', 'Affiliation': 'Monash University, Melbourne, VIC, Australia; ANZUP Cancer Trials Group, Sydney, NSW, Australia; Eastern Health, Melbourne, VIC, Australia.'}, {'ForeName': 'Tee S', 'Initials': 'TS', 'LastName': 'Lim', 'Affiliation': 'Genesis Cancer Care, Perth, WA, Australia; Curtin Medical School, Curtin University, Perth, WA, Australia.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Pearse', 'Affiliation': 'Auckland Hospital, Auckland, New Zealand.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30456-3']
3017,33002438,"Adjuvant radiotherapy versus early salvage radiotherapy plus short-term androgen deprivation therapy in men with localised prostate cancer after radical prostatectomy (GETUG-AFU 17): a randomised, phase 3 trial.","BACKGROUND


Adjuvant radiotherapy reduces the risk of biochemical progression in prostate cancer patients after radical prostatectomy. We aimed to compare adjuvant versus early salvage radiotherapy after radical prostatectomy, combined with short-term hormonal therapy, in terms of oncological outcomes and tolerance.
METHODS


GETUG-AFU 17 was a randomised, open-label, multicentre, phase 3 trial done at 46 French hospitals. Men aged at least 18 years who had an Eastern Cooperative Oncology Group performance status of 1 or less, localised adenocarcinoma of the prostate treated with radical prostatectomy, who had pathologically-staged pT3a, pT3b, or pT4a (with bladder neck invasion), pNx (without pelvic lymph nodes dissection), or pN0 (with negative lymph nodes dissection) disease, and who had positive surgical margins were eligible for inclusion in the study. Eligible patients were randomly assigned (1:1) to either immediate adjuvant radiotherapy or delayed salvage radiotherapy at the time of biochemical relapse. Random assignment, by minimisation, was done using web-based software and stratified by Gleason score, pT stage, and centre. All patients received 6 months of triptorelin (intramuscular injection every 3 months). The primary endpoint was event-free survival. Efficacy and safety analyses were done on the intention-to-treat population. The trial is registered with ClinicalTrials.gov, NCT00667069.
FINDINGS


Between March 7, 2008, and June 23, 2016, 424 patients were enrolled. We planned to enrol 718 patients, with 359 in each study group. However, on May 20, 2016, the independent data monitoring committee recommended early termination of enrolment because of unexpectedly low event rates. At database lock on Dec 19, 2019, the overall median follow-up time from random assignment was 75 months (IQR 50-100), 74 months (47-100) in the adjuvant radiotherapy group and 78 months (52-101) in the salvage radiotherapy group. In the salvage radiotherapy group, 115 (54%) of 212 patients initiated study treatment after biochemical relapse. 205 (97%) of 212 patients started treatment in the adjuvant group. 5-year event-free survival was 92% (95% CI 86-95) in the adjuvant radiotherapy group and 90% (85-94) in the salvage radiotherapy group (HR 0·81, 95% CI 0·48-1·36; log-rank p=0·42). Acute grade 3 or worse toxic effects occurred in six (3%) of 212 patients in the adjuvant radiotherapy group and in four (2%) of 212 patients in the salvage radiotherapy group. Late grade 2 or worse genitourinary toxicities were reported in 125 (59%) of 212 patients in the adjuvant radiotherapy group and 46 (22%) of 212 patients in the salvage radiotherapy group. Late genitourinary adverse events of grade 2 or worse were reported in 58 (27%) of 212 patients in the adjuvant radiotherapy group versus 14 (7%) of 212 patients in the salvage radiotherapy group (p<0·0001). Late erectile dysfunction was grade 2 or worse in 60 (28%) of 212 in the adjuvant radiotherapy group and 17 (8%) of 212 in the salvage radiotherapy group (p<0·0001).
INTERPRETATION


Although our analysis lacked statistical power, we found no benefit for event-free survival in patients assigned to adjuvant radiotherapy compared with patients assigned to salvage radiotherapy. Adjuvant radiotherapy increased the risk of genitourinary toxicity and erectile dysfunction. A policy of early salvage radiotherapy could spare men from overtreatment with radiotherapy and the associated adverse events.
FUNDING


French Health Ministry and Ipsen.",2020,"5-year event-free survival was 92% (95% CI 86-95) in the adjuvant radiotherapy group and 90% (85-94) in the salvage radiotherapy group (HR 0·81, 95% CI 0·48-1·36; log-rank p=0·42).","['Eligible patients', 'prostate cancer patients after radical prostatectomy', 'men with localised prostate cancer after radical prostatectomy (GETUG-AFU 17', 'Men aged at least 18 years who had an Eastern Cooperative Oncology Group performance status of 1 or less, localised adenocarcinoma of the prostate treated with radical prostatectomy, who had pathologically-staged pT3a, pT3b, or pT4a (with bladder neck invasion), pNx (without pelvic lymph nodes dissection), or pN0 (with negative lymph nodes dissection) disease, and who had positive surgical margins were eligible for inclusion in the study', 'GETUG-AFU 17 was a randomised, open-label, multicentre, phase 3 trial done at 46 French hospitals', '718 patients, with 359 in each study group', 'Between March 7, 2008, and June 23, 2016, 424 patients were enrolled']","['salvage radiotherapy plus short-term androgen deprivation therapy', 'adjuvant versus early salvage radiotherapy after radical prostatectomy, combined with short-term hormonal therapy', 'adjuvant radiotherapy', 'Adjuvant radiotherapy', 'triptorelin', 'salvage radiotherapy', 'radiotherapy', 'immediate adjuvant radiotherapy or delayed salvage radiotherapy']","['5-year event-free survival', 'Late erectile dysfunction', 'risk of genitourinary toxicity and erectile dysfunction', 'Late grade 2 or worse genitourinary toxicities', 'Acute grade 3 or worse toxic effects', 'Late genitourinary adverse events', 'event-free survival', 'Efficacy and safety analyses']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0392752', 'cui_str': 'Localized'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0007112', 'cui_str': 'Adenocarcinoma of prostate'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0227716', 'cui_str': 'Structure of neck of urinary bladder'}, {'cui': 'C1269955', 'cui_str': 'Tumour invasion'}, {'cui': 'C0193883', 'cui_str': 'Pelvic lymphadenectomy'}, {'cui': 'C0332396', 'cui_str': 'pN0 category'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0024203', 'cui_str': 'Excision of lymph node'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1709603', 'cui_str': 'Positive Surgical Margins'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0376246', 'cui_str': 'French language'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0085405', 'cui_str': 'Salvage therapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C0242939', 'cui_str': 'Adjuvant Radiotherapy'}, {'cui': 'C0077275', 'cui_str': 'Triptorelin'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0242350', 'cui_str': 'Impotence'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0042066', 'cui_str': 'Structure of genitourinary system'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]",424.0,0.16146,"5-year event-free survival was 92% (95% CI 86-95) in the adjuvant radiotherapy group and 90% (85-94) in the salvage radiotherapy group (HR 0·81, 95% CI 0·48-1·36; log-rank p=0·42).","[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Sargos', 'Affiliation': 'Institut Bergonié, Bordeaux, France. Electronic address: p.sargos@bordeaux.unicancer.fr.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Chabaud', 'Affiliation': 'Centre Léon Bérard, Lyon, France.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Latorzeff', 'Affiliation': 'Clinique Pasteur, Toulouse, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Magné', 'Affiliation': 'Institut de Cancérologie de la Loire, Saint-Priest-en-Jarèz, France.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Benyoucef', 'Affiliation': 'Centre Henri Becquerel, Rouen, France.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Supiot', 'Affiliation': ""Institut de Cancérologie de l'Ouest, Site René Gauducheau, Saint-Herblain, France.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Pasquier', 'Affiliation': 'Centre Oscar Lambret and Lille University, Lille, France.'}, {'ForeName': 'Menouar Samir', 'Initials': 'MS', 'LastName': 'Abdiche', 'Affiliation': 'Centre Hospitalier Robert Boulin, Libourne, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Gilliot', 'Affiliation': 'Clinique Marzet, Pau, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Graff-Cailleaud', 'Affiliation': 'Institut Claudius Regaud, Toulouse, France.'}, {'ForeName': 'Marlon', 'Initials': 'M', 'LastName': 'Silva', 'Affiliation': 'Centre François Baclesse, Caen, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Bergerot', 'Affiliation': ""Clinique Mutualiste de l'Estuaire, Cité Sanitaire, Saint-Nazaire, France.""}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Baumann', 'Affiliation': ""Centre d'Oncologie de Gentilly, Nancy, France.""}, {'ForeName': 'Yazid', 'Initials': 'Y', 'LastName': 'Belkacemi', 'Affiliation': 'Hôpitaux Universitaires Henri Mondor, Université Paris Est Créteil, Creteil, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Azria', 'Affiliation': ""Institut Régional du Cancer de Montpellier Val d'Aurelle, Montpellier, France.""}, {'ForeName': 'Meryem', 'Initials': 'M', 'LastName': 'Brihoum', 'Affiliation': 'Unicancer, Paris, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Soulié', 'Affiliation': 'CHU de Toulouse, Toulouse, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Richaud', 'Affiliation': 'Institut Bergonié, Bordeaux, France.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30454-X']
3018,33006618,Effect of Avoiding Cow's Milk Formula at Birth on Prevention of Asthma or Recurrent Wheeze Among Young Children: Extended Follow-up From the ABC Randomized Clinical Trial.,"Importance


Children with food allergies may develop asthma or recurrent wheeze.
Objective


To evaluate whether asthma or recurrent wheeze among children were changed by avoiding supplementing breastfeeding (BF) with cow's milk formula (CMF) in the first 3 days of life.
Design, Setting, and Participants


This randomized, unmasked, clinical trial was conducted at 1 university hospital in Japan beginning October 2013 with follow-up examinations occurring until January 2020. A total of 312 newborns at risk for atopy were randomized and assigned to either BF with or without amino acid-based elemental formula (EF) or BF with CMF, with follow-up examinations for participants showing signs of atopy conducted at 24 months. Follow-up examinations ran through January 2020.
Interventions


Immediately after birth, newborns were randomly assigned (1:1 ratio) to either breastfeeding with or without amino acid-based elemental formula for at least the first 3 days of life (no CMF group) or breastfeeding supplemented with CMF (≥5 mL/d) from the first day of life to 5 months of age (CMF group).
Main Outcomes and Measures


Asthma or recurrent wheeze diagnosed by the pediatric allergy specialists of this trial; subgroups were stratified by serum levels of 25-hydroxyvitamin D and IgE.
Results


Of 312 infants (156 [50.0%] randomized to the no CMF group), 302 (96.8%) were followed up at their second birthday: 77 of 151 (51.0%) in the no CMF group and 81 of 151 (53.6%) in the CMF group underwent extended follow-up because of having atopic conditions. Asthma or recurrent wheeze developed in 15 (9.9%) of the children in the no CMF group, significantly less than the children in the CMF group (27 [17.9%]; risk difference, -0.079; 95% CI, -0.157 to -0.002). In participants with vitamin D levels above the median at 5 months of age, asthma or recurrent wheeze developled in 5 (6.4%) children in the no CMF group, significantly less than in the children in the CMF group (17 [24.6%]; risk difference, -0.182; 95% CI, -0.298 to -0.067; P for interaction = .04). In the highest quartile group of total IgE at age 24 months, asthma or recurrent wheeze developed in 2 children (5.3%) in the no CMF group, significantly less than the children in the CMF group (14 [43.8%]; risk difference, -0.385; 95% CI, -0.571 to -0.199; P for interaction = .004).
Conclusions and Relevance


The findings of this study suggest that avoiding CMF supplementation in the first 3 days of life has the potential to reduce the risk of asthma or recurrent wheeze in young children, especially among those with high vitamin D or high IgE levels.
Trial Registration


umin.ac.jp/ctr Identifier: UMIN000011577.",2020,"Asthma or recurrent wheeze developed in 15 (9.9%) of the children in the no CMF group, significantly less than the children in the CMF group (27 [17.9%]; risk difference, -0.079; 95% CI, -0.157 to -0.002).","['Young Children', '1 university hospital in Japan beginning October 2013 with follow-up examinations occurring until January 2020', '312 newborns at risk for atopy']","[""avoiding supplementing breastfeeding (BF) with cow's milk formula (CMF"", ""Avoiding Cow's Milk Formula"", 'BF with or without amino acid-based elemental formula (EF) or BF with CMF, with follow-up examinations', 'breastfeeding with or without amino acid-based elemental formula for at least the first 3 days of life (no CMF group) or breastfeeding supplemented with CMF', 'avoiding CMF supplementation', 'CMF']","['Asthma or recurrent wheeze', 'asthma or recurrent wheeze', 'Main Outcomes and Measures\n\n\nAsthma or recurrent wheeze diagnosed by the pediatric allergy specialists', 'Prevention of Asthma or Recurrent Wheeze']","[{'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C4517706', 'cui_str': '312'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0392707', 'cui_str': 'Atopy'}]","[{'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0349374', 'cui_str': ""Cow's milk""}, {'cui': 'C0002520', 'cui_str': 'amino acids'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3853260', 'cui_str': 'Elemental formula'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0043144', 'cui_str': 'Wheezing'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0002111', 'cui_str': 'Allergy - specialty'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}]",,0.114499,"Asthma or recurrent wheeze developed in 15 (9.9%) of the children in the no CMF group, significantly less than the children in the CMF group (27 [17.9%]; risk difference, -0.079; 95% CI, -0.157 to -0.002).","[{'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Tachimoto', 'Affiliation': 'Division of Molecular Epidemiology, Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Eiji', 'Initials': 'E', 'LastName': 'Imanari', 'Affiliation': 'Department of Pediatrics, Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hidetoshi', 'Initials': 'H', 'LastName': 'Mezawa', 'Affiliation': 'Division of Molecular Epidemiology, Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Mai', 'Initials': 'M', 'LastName': 'Okuyama', 'Affiliation': 'Division of Molecular Epidemiology, Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Urashima', 'Affiliation': 'Division of Molecular Epidemiology, Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Daishi', 'Initials': 'D', 'LastName': 'Hirano', 'Affiliation': 'Division of Molecular Epidemiology, Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Gocho', 'Affiliation': 'Division of Molecular Epidemiology, Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Mitsuyoshi', 'Initials': 'M', 'LastName': 'Urashima', 'Affiliation': 'Division of Molecular Epidemiology, Jikei University School of Medicine, Tokyo, Japan.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.18534']
3019,33006749,Can Physical Activity While Sedentary Produce Health Benefits? A Single-Arm Randomized Trial.,"BACKGROUND


Sedentary time poses a risk to health. Substituting physical activity for inactivity is obvious but this requires a behavior change. Interventions advocated to decrease uninterrupted physical inactivity (defined as Metabolic Equivalent of Task (METS) less than 1.5) are important. One such intervention is accomplished with the Gentle Jogger (GJ), a low risk motorized wellness device which produces effortless, rapid motion of the lower extremities simulating locomotion or fidgeting. GJ produces health benefits in type 2 diabetes, heart disease, and high blood pressure. The purpose of this trial was to ascertain whether GJ increases METS above 1.5 to explain its effectiveness despite sedentary behavior or whether tapping is responsible.
METHODS


A randomized single-arm trial was conducted. Subjects were randomized to begin the study in either the supine or seated postures and on the same day crossed over with the starting posture reversed. Oxygen consumption was measured at rest and during GJ.
RESULTS


Twenty-six subjects were studied (15 women and 11 men) with a mean age of 44 ± 15 years and BMI 27.9 ± 5.0, 19 were overweight or obese, and 7 had normal BMI. GJ increased oxygen consumption and METS 15% in the seated posture and 13% in the supine posture. No individual receiving GJ achieved METS exceeding 1.5.
CONCLUSIONS


In a moderately obese population, GJ in seated or supine posture did not exceed 1.5 METS. The values are comparable to those reported for sit-stand interventions and cannot explain the health benefits of GJ.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03602365 . Registered on July 26, 2018.",2020,"No individual receiving GJ achieved METS exceeding 1.5.
","['Twenty-six subjects were studied (15 women and 11 men) with a mean age of 44 ± 15 years and BMI 27.9 ± 5.0, 19 were overweight or obese, and 7 had normal BMI']",['GJ'],"['oxygen consumption', 'uninterrupted physical inactivity', 'Oxygen consumption']","[{'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205307', 'cui_str': 'Normal'}]",[],"[{'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C3890554', 'cui_str': 'Physical Inactivity'}]",26.0,0.105384,"No individual receiving GJ achieved METS exceeding 1.5.
","[{'ForeName': 'Marvin A', 'Initials': 'MA', 'LastName': 'Sackner', 'Affiliation': 'Mt. Sinai Medical Center of Greater Miami, Miami Beach, FL, USA.'}, {'ForeName': 'Jose R', 'Initials': 'JR', 'LastName': 'Lopez', 'Affiliation': 'Mt. Sinai Medical Center of Greater Miami, Miami Beach, FL, USA.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Banderas', 'Affiliation': 'Sackner Wellness Products LLC, Miami, FL, USA.'}, {'ForeName': 'Jose A', 'Initials': 'JA', 'LastName': 'Adams', 'Affiliation': 'Mt. Sinai Medical Center of Greater Miami, Miami Beach, FL, USA. Tony@msmc.com.'}]",Sports medicine - open,['10.1186/s40798-020-00278-3']
3020,33006755,Carbamazepine versus levetiracetam in epilepsy due to neurocysticercosis.,"BACKGROUND


The choice of antiepileptic drug (AED) in newly diagnosed neurocysticercosis (NCC) patients with epilepsy continues to be arbitrary. We compared efficacy and side effect profile of levetiracetam (LEV) and carbamazepine (CBZ) for the treatment of seizures in newly diagnosed patients with NCC.
PATIENTS AND METHODS


This was an open-labeled randomized comparative monotherapy study including newly diagnosed drug naïve patients of NCC (n = 99) presenting with seizures who were randomized in 1:1 ratio using computed generated numbers. All patients were followed up for at least six months after start of treatment. The primary outcome measure was seizure control over six months following start of AEDs.
RESULTS


Fifteen (15.2%) patients [CBZ- 4(8.2%); LEV- 11(22%)] developed recurrence of seizures. A trend (p = 0.09) was found toward better control of seizures in CBZ compared to LEV. Two (4%) patients in LEV group and 17 (34.6%) patients in CBZ group developed drug-related minor side effects (p < 0.0001). Three patients in CBZ group needed discontinuation of therapy due to skin rash. Eleven patients who relapsed while on LEV did not have any recurrence of seizures after switching over to CBZ. Out of 3 patients who relapsed while receiving CBZ and were changed to LEV, two developed seizures during follow-up.
CONCLUSION


CBZ and LEV could be used as alternatives in newly diagnosed patients of NCC at the behest of minor side effects in the CBZ group.",2020,A trend (P=0.09) was found towards better control of seizures in CBZ compared to LEV.,"['newly diagnosed patients with NCC', 'newly diagnosed drug naïve patients of NCC (n=99) presenting with seizures', '11 patients who relapsed while on', 'epilepsy due to neurocysticercosis', 'newly diagnosed neurocysticercosis (NCC) patients with epilepsy']","['CBZ and LEV', 'Carbamazepine Versus levetiracetam', 'LEV', 'Levetiracetam (LEV) and carbamazepine (CBZ', 'CBZ']","['recurrence of seizures', 'discontinuation of therapy due to skin rash', 'seizure control over six months following start of AEDs']","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0338437', 'cui_str': 'Cysticercosis of central nervous system'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]","[{'cui': 'C0006949', 'cui_str': 'Carbamazepine'}, {'cui': 'C0377265', 'cui_str': 'Levetiracetam'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0180309', 'cui_str': 'Automated External Defibrillators'}]",99.0,0.0858629,A trend (P=0.09) was found towards better control of seizures in CBZ compared to LEV.,"[{'ForeName': 'Akhil P', 'Initials': 'AP', 'LastName': 'Santhosh', 'Affiliation': 'Department of Internal Medicine, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Manoj', 'Initials': 'M', 'LastName': 'Kumar Goyal', 'Affiliation': 'Department of Neurology, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Manish', 'Initials': 'M', 'LastName': 'Modi', 'Affiliation': 'Department of Neurology, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Parampreet S', 'Initials': 'PS', 'LastName': 'Kharbanda', 'Affiliation': 'Department of Neurology, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Chirag K', 'Initials': 'CK', 'LastName': 'Ahuja', 'Affiliation': 'Department of Radiodiagnosis and Imaging, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Naresh', 'Initials': 'N', 'LastName': 'Tandyala', 'Affiliation': 'Department of Neurology, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Nandita', 'Initials': 'N', 'LastName': 'Prabhat', 'Affiliation': 'Department of Neurology, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Rajveer', 'Initials': 'R', 'LastName': 'Singh', 'Affiliation': 'Department of Neurology, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Sahil', 'Initials': 'S', 'LastName': 'Mehta', 'Affiliation': 'Department of Neurology, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Karthik', 'Initials': 'K', 'LastName': 'Vinay Mahesh', 'Affiliation': 'Department of Neurology, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}]",Acta neurologica Scandinavica,['10.1111/ane.13355']
3021,33010091,Can targeting information on cancer-related psychosocial services by male gender and rurality improve attitude to service use in this difficult-to-engage population?,"OBJECTIVE


Rural men affected by cancer are difficult to engage in psychosocial support services. This exploratory study tested whether exposure to printed brochures describing services, distinguished by a focus on rural men affected by cancer, resulted in more positive help-seeking attitudes than exposure to material focused on rural location only or generic cancer support material.
METHODS


Targeted versions of a South Australian Cancer Council service brochure were developed to enhance cultural appropriateness, consistent with the Elaboration Likelihood Model. Rural men affected by cancer were recruited via supportive accommodation and randomized to receive one of the three brochures. The primary outcome was positive attitude to help-seeking at post-test (between 1 and 2 days). Negative attitudes to help-seeking, intention to seek help, perceived isolation, and service use were secondary outcomes; perceived information relevance at immediate post-test was also measured.
RESULTS


Analysis (N = 114) indicated no detectable group differences (rurality/male gender, n = 33; rurality, n = 41; control, n = 40) on primary or secondary outcome measures (p > 0.05). Participants' existing service use was high, due to the recruitment methods. Support service information was primarily sourced from other people (e.g., friends/family, 22.22%; medical professionals, 27.27%).
CONCLUSIONS


Existing service use rates suggest that ceiling effects obscured any potential benefit from demographic targeting of materials. Further research should consider building understanding about the acceptability of targeting techniques in this population, replication with materials designed with greater consumer input, and employ samples recruited outside a support service.",2020,"RESULTS


Analysis (N=114) indicated no detectable group differences (rurality/male gender, n=33; rurality, n=41; control, n=40) on primary or secondary outcome measures (p>.05).","['Rural men affected by cancer', 'Targeted versions of a South Australian Cancer Council service brochure', 'rural men affected by cancer, resulted in more positive help-seeking attitudes than exposure to material focused on rural location only or generic cancer support material']",[],['positive attitude to help-seeking at post-test'],"[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C0183683', 'cui_str': 'Support'}]",[],"[{'cui': 'C0237428', 'cui_str': 'Positive attitude'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",,0.119919,"RESULTS


Analysis (N=114) indicated no detectable group differences (rurality/male gender, n=33; rurality, n=41; control, n=40) on primary or secondary outcome measures (p>.05).","[{'ForeName': 'Nathan J', 'Initials': 'NJ', 'LastName': 'Harrison', 'Affiliation': 'School of Psychology, University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Kate M', 'Initials': 'KM', 'LastName': 'Gunn', 'Affiliation': ""Freemasons Foundation Centre for Men's Health, Adelaide Medical School, University of Adelaide, Adelaide, South Australia, Australia.""}, {'ForeName': 'Carlene J', 'Initials': 'CJ', 'LastName': 'Wilson', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, South Australia, Australia.'}]",Psycho-oncology,['10.1002/pon.5566']
3022,33010148,Effects and Mechanisms of Dapagliflozin Treatment on Ambulatory Blood Pressure in Diabetic Patients with Hypertension.,"BACKGROUND Studies have shown that dapagliflozin has antihypertensive effects. However, the effects and mechanisms of dapagliflozin on ambulatory blood pressure (ABP) have not been fully evaluated. In this study, we aimed to evaluate the effects of dapagliflozin treatment on ABP in patients with type 2 diabetes and hypertension. MATERIAL AND METHODS Patients were prospectively enrolled and divided into 2 groups: dapagliflozin treatment group (n=182) and no dapagliflozin treatment group (n=304). Clinical characteristics and measures of treatment, serum uric acid (SUA), 24-h urinary UA (UUA) excretion, and 24-h ABP were collected. The effects and mechanisms of dapagliflozin on 24-h ABP were evaluated. RESULTS After 3 months, the patients without dapagliflozin treatment had higher SUA, lower 24-h UUA excretion, and higher 24-h and daytime systolic blood pressure (SBP) (P<0.05) compared to patients with dapagliflozin treatment. After adjusting for covariates, results showed that dapagliflozin treatment was significantly associated with reduced 24-h SBP (ß=-0.29 and P=0.02) and reduced daytime SBP (ß=-0.33 and P=0.009). After additionally adjusting for SUA and 24-h UUA excretion, there were no significant relationships found between dapagliflozin treatment and 24-h (ß=-012, P=0.10) and daytime SBP (ß=-0.20, P=0.06). CONCLUSIONS In patients with diabetes and hypertension, dapagliflozin treatment was associated with reduced 24-h and daytime SBP, which could be related to the drug's effect of increasing 24-h UUA excretion.",2020,"After 3 months, the patients without dapagliflozin treatment had higher SUA, lower 24-h UUA excretion, and higher 24-h and daytime systolic blood pressure (SBP) (P<0.05) compared to patients with dapagliflozin treatment.","['Diabetic Patients with Hypertension', 'patients with type 2 diabetes and hypertension', 'Patients were prospectively enrolled and divided into 2 groups']","['dapagliflozin treatment group (n=182) and no dapagliflozin treatment', 'Dapagliflozin Treatment', 'dapagliflozin']","['reduced daytime SBP', '24-h ABP', 'Ambulatory Blood Pressure', 'daytime SBP', 'reduced 24-h and daytime SBP', '24-h UUA excretion', 'ambulatory blood pressure (ABP', 'serum uric acid (SUA), 24-h urinary UA (UUA) excretion, and 24-h ABP', 'reduced 24-h SBP', 'SUA and 24-h UUA excretion', 'higher SUA, lower 24-h UUA excretion, and higher 24-h and daytime systolic blood pressure (SBP']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0855316', 'cui_str': 'Blood pressure ambulatory'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0455272', 'cui_str': 'Serum urate measurement'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",,0.015103,"After 3 months, the patients without dapagliflozin treatment had higher SUA, lower 24-h UUA excretion, and higher 24-h and daytime systolic blood pressure (SBP) (P<0.05) compared to patients with dapagliflozin treatment.","[{'ForeName': 'Zirao', 'Initials': 'Z', 'LastName': 'Hao', 'Affiliation': ""Department of Endocrinology, The Third People's Hospital of Huizhou, Huizhou, Guangdong, China (mainland).""}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': ""Department of Endocrinology, The Third People's Hospital of Huizhou, Huizhou, Guangdong, China (mainland).""}, {'ForeName': 'Yingzhen', 'Initials': 'Y', 'LastName': 'Wen', 'Affiliation': ""Department of Endocrinology, The Third People's Hospital of Huizhou, Huizhou, Guangdong, China (mainland).""}, {'ForeName': 'Lijuan', 'Initials': 'L', 'LastName': 'Cui', 'Affiliation': ""Department of Endocrinology, The Third People's Hospital of Huizhou, Huizhou, Guangdong, China (mainland).""}, {'ForeName': 'Guiping', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': ""Department of Endocrinology, The Third People's Hospital of Huizhou, Huizhou, Guangdong, China (mainland).""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Department of Cardiology, The Third People's Hospital of Huizhou, Huizhou, Guangdong, China (mainland).""}]",Medical science monitor : international medical journal of experimental and clinical research,['10.12659/MSM.925987']
3023,33010240,"Dolutegravir with emtricitabine and tenofovir alafenamide or tenofovir disoproxil fumarate versus efavirenz, emtricitabine, and tenofovir disoproxil fumarate for initial treatment of HIV-1 infection (ADVANCE): week 96 results from a randomised, phase 3, non-inferiority trial.","BACKGROUND


ADVANCE compared the efficacy and safety of two antiretroviral first-line combinations (dolutegravir combined with emtricitabine and either tenofovir disoproxil fumarate or tenofovir alafenamide), with a third regimen (efavirenz combined with emtricitabine and tenofovir disoproxil fumarate) previously recommended by WHO. Here, we report the 96-week data for the study.
METHODS


This randomised, open-label, non-inferiority phase 3 trial, was done at two research sites in Johannesburg, South Africa, after participant recruitment from 11 public health clinics also in Johannesburg. Eligible participants were aged 12 years or older with HIV-1 infection, who weighed at least 40 kg, had no antiretroviral exposure in the previous 6 months, with a creatinine clearance of more than 60 mL/min (>80 mL per min in individuals aged <19 years), and a plasma HIV-1 RNA concentration of 500 copies per mL or higher. Individuals who were pregnant or had tuberculosis were excluded. Participants were randomly assigned (1:1:1) by study staff using a computerised randomisation system. Randomisation was stratified by age (12 and <19 years and ≥19 years). Participants were randomly assigned to once-daily oral fixed-dose combination tenofovir alafenamide 25 mg and emtricitabine 200 mg, and once-daily oral dolutegravir 50 mg; once-daily oral fixed-dose combination tenofovir disoproxil fumarate 300 mg and emtricitabine 200 mg, and once-daily oral dolutegravir 50 mg; or once-daily oral fixed-dose combination of tenofovir disoproxil fumarate 300 mg, emtricitabine 200 mg, and efavirenz 600 mg. The primary efficacy endpoint was the proportion of participants who had a plasma HIV-1 RNA concentration of less than 50 copies per mL at week 48, which has been reported previously. Here, we report the key secondary efficacy endpoint of the proportion of participants who had a plasma HIV-1 RNA concentration of less than 50 copies per mL at the week 96 visit, assessed in all participants who received at least one dose of any study drug, with a prespecified non-inferiority margin of -10%. Safety data, including clinical, dual-energy X-ray absorptiometry and laboratory data, are also reported. This study was registered with ClinicalTrials.gov, NCT03122262.
FINDINGS


Between Jan 17, 2017, and May 14, 2018, we screened 1453 individuals, of whom 1053 were enrolled: 351 participants were randomly assigned to the tenofovir alafenamide, emtricitabine, and dolutegravir group, 351 to the tenofovir disoproxil fumarate, emtricitabine, and dolutegravir group, and 351 to the tenofovir disoproxil fumarate, emtricitabine, and efavirenz group. All participants received at least one dose of study medication and were included in the primary analysis. At week 96, 276 (79%) of 351 participants in the tenofovir alafenamide, emtricitabine, and dolutegravir group, 275 (78%) of 351 participants in the tenofovir disoproxil fumarate, emtricitabine, and dolutegravir group, and 258 (74%) of 351 participants in the tenofovir disoproxil fumarate, emtricitabine, and efavirenz group had achieved a plasma HIV-1 RNA concentration of less than 50 copies per mL. Non-inferiority was established in all three comparisons. The proportion of patients with protocol-defined virological failure at week 96 was low in all treatment groups. Participants in the tenofovir alafenamide, emtricitabine, and dolutegravir group had fewer changes in bone density than the two other treatment groups. Mean weight gain was substantial (7·1 kg [SD 7·4] in the tenofovir alafenamide, emtricitabine, and dolutegravir group; 4·3 kg [6·7] in the tenofovir disoproxil fumarate, emtricitabine, and dolutegravir group, and 2·3 kg [7·0] in the tenofovir disoproxil fumarate, emtricitabine, and efavirenz group), and was greater among women than men. Ten (3%) of 351 participants in the tenofovir disoproxil fumarate, emtricitabine, and efavirenz group discontinued due to treatment-related adverse events, of which liver dysfunction (n=4) and rash (n=4) were most common.
INTERPRETATION


Medium-term and long-term metabolic and clinical consequences of the considerable increase in bodyweight observed in participants given these antiretroviral regimens and the trajectory of this weight gain over time, especially among women, require further study.
FUNDING


USAID, Unitaid, South African Medical Research Council, ViiV Healthcare.",2020,The proportion of patients with protocol-defined virological failure at week 96 was low in all treatment groups.,"['Individuals who were pregnant or had tuberculosis were excluded', 'two research sites in Johannesburg, South Africa, after participant recruitment from 11 public health clinics also in Johannesburg', 'women than men', 'group, and 258 (74%) of 351 participants in the', 'Between Jan 17, 2017, and May 14, 2018, we screened 1453 individuals, of whom 1053 were enrolled: 351 participants', 'participants who had a plasma HIV-1 RNA concentration of less than 50 copies per mL at the week 96 visit, assessed in all participants who received at least one dose of any study drug, with a prespecified non-inferiority margin of -10', 'Eligible participants were aged 12 years or older with HIV-1 infection, who weighed at least 40 kg, had no antiretroviral exposure in the previous 6 months, with a creatinine clearance of more than 60 mL/min (>80 mL per min in individuals aged <19 years']","['tenofovir alafenamide, emtricitabine, and dolutegravir', 'tenofovir alafenamide, emtricitabine, and dolutegravir group, 351 to the tenofovir disoproxil fumarate, emtricitabine, and dolutegravir group, and 351 to the tenofovir disoproxil fumarate, emtricitabine, and efavirenz group', 'efavirenz combined with emtricitabine and tenofovir disoproxil fumarate', 'tenofovir disoproxil fumarate, emtricitabine, and dolutegravir', 'antiretroviral first-line combinations (dolutegravir combined with emtricitabine and either tenofovir disoproxil fumarate or tenofovir alafenamide', 'tenofovir disoproxil fumarate, emtricitabine, and dolutegravir group, and 2·3 kg [7·0] in the tenofovir disoproxil fumarate, emtricitabine, and efavirenz', 'tenofovir alafenamide, emtricitabine', 'tenofovir disoproxil fumarate, emtricitabine, and efavirenz', 'tenofovir alafenamide 25 mg and emtricitabine 200 mg, and once-daily oral dolutegravir 50 mg; once-daily oral fixed-dose combination tenofovir disoproxil fumarate 300 mg and emtricitabine 200 mg, and once-daily oral dolutegravir 50 mg; or once-daily oral fixed-dose combination of tenofovir disoproxil fumarate 300 mg, emtricitabine 200 mg, and efavirenz', 'emtricitabine and tenofovir alafenamide or tenofovir disoproxil fumarate versus efavirenz, emtricitabine, and tenofovir disoproxil fumarate']","['plasma HIV-1 RNA concentration', 'efficacy and safety', 'bone density', 'virological failure', 'Mean weight gain', 'proportion of participants who had a plasma HIV-1 RNA concentration']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0369499', 'cui_str': 'Human immunodeficiency virus 1 RNA'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439526', 'cui_str': '/mL'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0237666', 'cui_str': 'Inferiority feeling'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C2363741', 'cui_str': 'HIV-1 infection'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C0439232', 'cui_str': 'min'}]","[{'cui': 'C3713958', 'cui_str': 'tenofovir alafenamide'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}, {'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0674428', 'cui_str': 'efavirenz'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C4083965', 'cui_str': 'tenofovir alafenamide 25 MG'}, {'cui': 'C1331249', 'cui_str': 'emtricitabine 200 MG'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3663830', 'cui_str': 'dolutegravir 50 MG'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1576947', 'cui_str': 'Tenofovir disoproxil fumarate 300 MG'}, {'cui': 'C4059167', 'cui_str': 'emtricitabine and tenofovir alafenamide'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0369499', 'cui_str': 'Human immunodeficiency virus 1 RNA'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0205466', 'cui_str': 'Virologic'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}]",351.0,0.359649,The proportion of patients with protocol-defined virological failure at week 96 was low in all treatment groups.,"[{'ForeName': 'Willem D F', 'Initials': 'WDF', 'LastName': 'Venter', 'Affiliation': 'Ezintsha, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa. Electronic address: fventer@ezintsha.org.'}, {'ForeName': 'Simiso', 'Initials': 'S', 'LastName': 'Sokhela', 'Affiliation': 'Ezintsha, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Bryony', 'Initials': 'B', 'LastName': 'Simmons', 'Affiliation': 'Department of Infectious Disease, Imperial College London, London, UK.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Moorhouse', 'Affiliation': 'Ezintsha, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Fairlie', 'Affiliation': 'Wits Reproductive Health and HIV Institute, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Nkuli', 'Initials': 'N', 'LastName': 'Mashabane', 'Affiliation': 'Ezintsha, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Celicia', 'Initials': 'C', 'LastName': 'Serenata', 'Affiliation': 'Ezintsha, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Godspower', 'Initials': 'G', 'LastName': 'Akpomiemie', 'Affiliation': 'Ezintsha, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Masebole', 'Initials': 'M', 'LastName': 'Masenya', 'Affiliation': 'Wits Reproductive Health and HIV Institute, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Ambar', 'Initials': 'A', 'LastName': 'Qavi', 'Affiliation': 'School of Public Health, Imperial College London, London, UK.'}, {'ForeName': 'Nomathemba', 'Initials': 'N', 'LastName': 'Chandiwana', 'Affiliation': 'Ezintsha, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Kaitlyn', 'Initials': 'K', 'LastName': 'McCann', 'Affiliation': 'School of Public Health, Imperial College London, London, UK.'}, {'ForeName': 'Shane', 'Initials': 'S', 'LastName': 'Norris', 'Affiliation': 'South African Medical Research Council and Wits Developmental Pathways for Health Research Unit, Department of Pediatrics, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Chersich', 'Affiliation': 'Wits Reproductive Health and HIV Institute, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Maartens', 'Affiliation': 'Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Samanta', 'Initials': 'S', 'LastName': 'Lalla-Edward', 'Affiliation': 'Ezintsha, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Alinda', 'Initials': 'A', 'LastName': 'Vos', 'Affiliation': 'Ezintsha, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, Netherlands.'}, {'ForeName': 'Polly', 'Initials': 'P', 'LastName': 'Clayden', 'Affiliation': 'HIV i-Base, London, UK.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Abrams', 'Affiliation': 'ICAP at Columbia University, Mailman School of Public Health, Columbia University, New York, NY, USA; Department of Pediatrics, Vagelos College of Physicians and Surgeons, Columbia University, New York, NY, USA.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Arulappan', 'Affiliation': 'Ezintsha, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Hill', 'Affiliation': 'Department of Translational Medicine, Liverpool University, Liverpool, UK.'}]",The lancet. HIV,['10.1016/S2352-3018(20)30241-1']
3024,33010241,"Dolutegravir-based and low-dose efavirenz-based regimen for the initial treatment of HIV-1 infection (NAMSAL): week 96 results from a two-group, multicentre, randomised, open label, phase 3 non-inferiority trial in Cameroon.","BACKGROUND


Updated WHO guidelines recommend a dolutegravir-based regimen as the preferred first-line treatment for HIV infection and low-dose efavirenz (400 mg) as an alternative. We aimed to report the non-inferior efficacy of dolutegravir compared with efavirenz 400 mg at week 96.
METHODS


We did a multicentre, randomised, open label, phase 3 trial in in three hospitals in Yaoundé, Cameroon, in HIV-1 infected antiretroviral-naive adults with an HIV RNA viral load of greater than 1000 copies per mL to compare dolutegravir 50 mg with efavirenz 400 mg (reference treatment), both combined with lamivudine and tenofovir disoproxil fumarate. The primary endpoint was the proportion with a viral load of less than 50 copies per mL at week 48 (10% non-inferiority margin). The study is registered with ClinicalTrials.gov, NCT02777229 and is ongoing.
FINDINGS


Between July, 2016, and August, 2019, of 820 patients assessed, 613 were randomly assigned to receive at least one dose of study medication, with 310 in the dolutegravir group and 303 in the efavirenz 400 mg group. At week 96 in the intention-to-treat analysis, 229 (74%) of 310 patients receiving dolutegravir and 219 (72%) of 303 patients receiving efavirenz, achieved plasma HIV-1 RNA less than 50 copies per mL (difference 1·6%, 95% CI -5·4 to 8·6; p=0.66). Viral load suppression was reached significantly more rapidly in the dolutegravir group (p<0·001). Virological failure (>1000 copies per mL) was observed in 27 patients (eight in the dolutegravir group, among which, three women switched to efavirenz 600 mg because of the dolutegravir teratogeneicity signal, and 19 in the efavirenz 400 mg group). No acquired resistance mutations to dolutegravir were observed against 17 mutations to efavirenz with or without mutations to lamivudine and tenofovir disoproxil fumarate among the 19 efavirenz 400 mg participants with virological failure. Weight gain was greater in the dolutegravir group (median weight gain, 5·0 kg in the dolutegravir group and 3·0 kg in the efavirenz 400 mg group, p<0·001, and incidence of obesity, 22% in the dolutegravir group and 16% in the efavirenz 400 mg group, p=0·043). The incidence of new WHO HIV-related stage 3 and 4 events was similar in each group (12 [4%] in each group). The two groups had similar rates of serious adverse events (28 [9%] of 310 in the dolutegravir group and 21 [7%] of 303 in the efavirenz 400 mg group). 18 deaths were observed during the 96-week follow-up (eight in the dolutegravir group and ten in the efavirenz 400 mg group).
INTERPRETATION


The non-inferior efficacy of the dolutegravir-based regimen and non-emergence of dolutegravir resistance at 96 weeks supports its use as a first-line regimen for antiretroviral-naive adults with HIV-1 infection. Viral load suppression was reached more quickly in the dolutegravir group and weight gain was significantly higher.
FUNDING


UNITAID and the French National Agency for AIDS Research.",2020,Viral load suppression was reached significantly more rapidly in the dolutegravir group (p<0·001).,"['HIV-1 infection (NAMSAL', '400 mg participants with virological failure', 'three hospitals in Yaoundé, Cameroon, in HIV-1 infected antiretroviral-naive adults with an HIV RNA viral load of greater than 1000 copies per mL to compare', 'antiretroviral-naive adults with HIV-1 infection', 'Between July, 2016, and August, 2019, of 820 patients assessed, 613 were randomly assigned to receive at least one dose of study medication, with 310 in the dolutegravir group and 303 in the']","['dolutegravir', 'dolutegravir 50 mg with efavirenz 400 mg (reference treatment), both combined with lamivudine and tenofovir disoproxil fumarate', 'efavirenz', 'Dolutegravir-based and low-dose efavirenz', 'dolutegravir-based regimen and non-emergence of dolutegravir resistance', 'lamivudine and tenofovir disoproxil fumarate']","['plasma HIV-1 RNA less', 'weight gain', 'Virological failure', 'Weight gain', 'incidence of new WHO HIV-related stage 3 and 4 events', 'Viral load suppression', 'rates of serious adverse events', 'proportion with a viral load']","[{'cui': 'C2363741', 'cui_str': 'HIV-1 infection'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0205466', 'cui_str': 'Virologic'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0006802', 'cui_str': 'Cameroon'}, {'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0439526', 'cui_str': '/mL'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C5191352', 'cui_str': '310'}, {'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C3663830', 'cui_str': 'dolutegravir 50 MG'}, {'cui': 'C4555930', 'cui_str': 'efavirenz 400 MG'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C3871446', 'cui_str': 'lamivudine and tenofovir disoproxil'}, {'cui': 'C0016801', 'cui_str': 'Fumarates'}, {'cui': 'C0674428', 'cui_str': 'efavirenz'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0369499', 'cui_str': 'Human immunodeficiency virus 1 RNA'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0205466', 'cui_str': 'Virologic'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",613.0,0.189368,Viral load suppression was reached significantly more rapidly in the dolutegravir group (p<0·001).,"[{'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Calmy', 'Affiliation': 'Division of Infectious Diseases, HIV-AIDS Unit, Geneva University Hospitals, Geneva, Switzerland. Electronic address: alexandra.calmy@hcuge.ch.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Tovar Sanchez', 'Affiliation': 'TransVIHMI, University of Montpellier, IRD, INSERM, 34394 Montpellier, France.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Kouanfack', 'Affiliation': 'Faculty of Medicine and Pharmaceutical Sciences, University of Dschang, Dschang, Cameroon; Day Stay Hospital, Central Hospital of Yaoundé, Henri-Dunant, Yaoundé, Cameroon; ANRS Cameroon site, Central Hospital of Yaoundé, Henri-Dunant, Yaoundé, Cameroon.'}, {'ForeName': 'Mireille', 'Initials': 'M', 'LastName': 'Mpoudi-Etame', 'Affiliation': 'Regional Military Hospital Number 1, Yaoundé, Cameroon.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Leroy', 'Affiliation': 'TransVIHMI, University of Montpellier, IRD, INSERM, 34394 Montpellier, France.'}, {'ForeName': 'Ségolène', 'Initials': 'S', 'LastName': 'Perrineau', 'Affiliation': 'TransVIHMI, University of Montpellier, IRD, INSERM, 34394 Montpellier, France.'}, {'ForeName': 'Martial', 'Initials': 'M', 'LastName': 'Lantche Wandji', 'Affiliation': 'ANRS Cameroon site, Central Hospital of Yaoundé, Henri-Dunant, Yaoundé, Cameroon.'}, {'ForeName': 'Darius', 'Initials': 'D', 'LastName': 'Tetsa Tata', 'Affiliation': 'ANRS Cameroon site, Central Hospital of Yaoundé, Henri-Dunant, Yaoundé, Cameroon.'}, {'ForeName': 'Pierette', 'Initials': 'P', 'LastName': 'Omgba Bassega', 'Affiliation': 'Cité Verte District Hospital, Cité Verte District, Yaoundé, Cameroon.'}, {'ForeName': 'Thérèse', 'Initials': 'T', 'LastName': 'Abong Bwenda', 'Affiliation': 'ANRS Cameroon site, Central Hospital of Yaoundé, Henri-Dunant, Yaoundé, Cameroon.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Varloteaux', 'Affiliation': 'ANRS Cameroon site, Central Hospital of Yaoundé, Henri-Dunant, Yaoundé, Cameroon.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Tongo', 'Affiliation': 'Emerging and Re-emerging Diseases Research Centre, IMPM, Sise à Ngoa-Ekelle, Yaoundé, Cameroon.'}, {'ForeName': 'Eitel', 'Initials': 'E', 'LastName': 'Mpoudi-Ngolé', 'Affiliation': 'Emerging and Re-emerging Diseases Research Centre, IMPM, Sise à Ngoa-Ekelle, Yaoundé, Cameroon.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Montoyo', 'Affiliation': 'Office of International Research and Collaboration, ANRS Inserm, Paris, France.'}, {'ForeName': 'Noémie', 'Initials': 'N', 'LastName': 'Mercier', 'Affiliation': 'Office of Clinical Trial Safety, ANRS Inserm, Paris, France.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'LeMoing', 'Affiliation': 'TransVIHMI, University of Montpellier, IRD, INSERM, 34394 Montpellier, France; Montpellier University Hospital Centre, Montpellier, France.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Peeters', 'Affiliation': 'TransVIHMI, University of Montpellier, IRD, INSERM, 34394 Montpellier, France.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Reynes', 'Affiliation': 'TransVIHMI, University of Montpellier, IRD, INSERM, 34394 Montpellier, France; Montpellier University Hospital Centre, Montpellier, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Delaporte', 'Affiliation': 'TransVIHMI, University of Montpellier, IRD, INSERM, 34394 Montpellier, France; Montpellier University Hospital Centre, Montpellier, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. HIV,['10.1016/S2352-3018(20)30238-1']
3025,33010242,"Safety and immunogenicity of two heterologous HIV vaccine regimens in healthy, HIV-uninfected adults (TRAVERSE): a randomised, parallel-group, placebo-controlled, double-blind, phase 1/2a study.","BACKGROUND


Bioinformatically designed mosaic antigens increase the breadth of HIV vaccine-elicited immunity. This study compared the safety, tolerability, and immunogenicity of a newly developed, tetravalent Ad26 vaccine with the previously tested trivalent formulation.
METHODS


This randomised, parallel-group, placebo-controlled, double-blind, phase 1/2a study (TRAVERSE) was done at 11 centres in the USA and one centre in Rwanda. Eligible participants were adults aged 18 to 50 years, who were HIV-uninfected, healthy at screening based on their medical history and a physical examination including laboratory assessment and vital sign measurements, and at low risk of HIV infection in the opinion of study staff, who applied a uniform definition of low-risk guidelines that was aligned across sites. Enrolled participants were randomly assigned at a 2:1 ratio to tetravalent and trivalent groups. Participants in tetravalent and trivalent groups were then further randomly assigned at a 5:1 ratio to adenovirus 26 (Ad26)-vectored vaccine and placebo subgroups. Randomisation was stratified by region (USA and Rwanda) and based on a computer-generated schedule using randomly permuted blocks prepared under the sponsor's supervision. We masked participants and investigators to treatment allocation throughout the study. On day 0, participants received a first injection of tetravalent vaccine (Ad26.Mos4.HIV or placebo) or trivalent vaccine (Ad26.Mos.HIV or placebo), and those injections were repeated 12 weeks later. At week 24, vaccine groups received a third dose of tetravalent or trivalent together with clade C gp140, and this was repeated at week 48, with placebos again administered to the placebo group. All study vaccines and placebo were administered by intramuscular injection in the deltoid muscle. We assessed adverse events in all participants who received at least one study injection (full analysis set) and Env-specific binding antibodies in all participants who received at least the first three vaccinations according to the protocol-specified vaccination schedule, had at least one measured post-dose blood sample collected, and were not diagnosed with HIV during the study (per-protocol set). This study is registered with Clinicaltrials.gov, NCT02788045.
FINDINGS


Of 201 participants who were enrolled and randomly assigned, 198 received the first vaccination: 110 were in the tetravalent group, 55 in the trivalent group, and 33 in the placebo group. Overall, 185 (93%) completed two scheduled vaccinations per protocol, 180 (91%) completed three, and 164 (83%) completed four. Solicited, self-limiting local, systemic reactogenicity and unsolicited adverse events were similar in vaccine groups and higher than in placebo groups. All participants in the per-protocol set developed clade C Env binding antibodies after the second vaccination, with higher total IgG titres after the tetravalent vaccine than after the trivalent vaccine (10 413 EU/mL, 95% CI 7284-14 886 in the tetravalent group compared with 5494 EU/mL, 3759-8029 in the trivalent group). Titres further increased after the third and fourth vaccinations, persisting at least through week 72. Other immune responses were also higher with the tetravalent vaccine, including the magnitude and breadth of binding antibodies against a cross-clade panel of Env antigens, and the magnitude of IFNγ ELISPOT responses (median 521 SFU/10 6  peripheral blood mononuclear cells [PBMCs] in the tetravalent group and median 282 SFU/10 6  PBMCs in the trivalent group after the fourth vaccination) and Env-specific CD4+ T-cell response rates after the third and fourth vaccinations. No interference by pre-existing Ad26 immunity was identified.
INTERPRETATION


The tetravalent vaccine regimen was generally safe, well-tolerated, and found to elicit higher immune responses than the trivalent regimen. Regimens that use this tetravalent vaccine component are being advanced into field trials to assess efficacy against HIV-1 infection.
FUNDING


National Institutes of Health, Henry M Jackson Foundation for Advancement of Military Medicine and the US Department of Defense, Ragon Institute of MGH, MIT, & Harvard, Bill & Melinda Gates Foundation, and Janssen Vaccines & Prevention.",2020,"Solicited, self-limiting local, systemic reactogenicity and unsolicited adverse events were similar in vaccine groups and higher than in placebo groups.","['Eligible participants were adults aged 18 to 50 years, who were HIV-uninfected, healthy at screening based on their medical history and a physical examination including laboratory assessment and vital sign measurements, and at low risk of HIV infection in the opinion of study staff, who applied a uniform definition of low-risk guidelines that was aligned across sites', '11 centres in the USA and one centre in Rwanda', 'healthy, HIV-uninfected adults (TRAVERSE', '201 participants who were enrolled and randomly assigned']","['HIV or placebo', 'tetravalent vaccine (Ad26.Mos4.HIV or placebo) or trivalent vaccine (Ad26.Mos', 'heterologous HIV vaccine regimens', 'placebos again administered to the placebo', 'placebo', 'adenovirus 26 (Ad26)-vectored vaccine and placebo']","['clade C Env binding antibodies', 'total IgG titres', 'Solicited, self-limiting local, systemic reactogenicity and unsolicited adverse events', 'Safety and immunogenicity', 'adverse events', 'IFNγ ELISPOT responses', 'safety, tolerability, and immunogenicity', 'Env-specific CD4+ T-cell response rates']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0019693', 'cui_str': 'Human immunodeficiency virus infection'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0035978', 'cui_str': 'Rwanda'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0001483', 'cui_str': 'Adenoviridae'}, {'cui': 'C0439860', 'cui_str': 'Heterologous'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0012656', 'cui_str': 'Infectious Disease Vectors'}]","[{'cui': 'C0017343', 'cui_str': 'ENV gene'}, {'cui': 'C0332297', 'cui_str': 'Bounded by'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0920508', 'cui_str': 'Enzyme linked immunospot assay'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}]",,0.625106,"Solicited, self-limiting local, systemic reactogenicity and unsolicited adverse events were similar in vaccine groups and higher than in placebo groups.","[{'ForeName': 'Lindsey R', 'Initials': 'LR', 'LastName': 'Baden', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA. Electronic address: lbaden@bwh.harvard.edu.""}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Stieh', 'Affiliation': 'Janssen Vaccines & Prevention, Leiden, Netherlands.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Sarnecki', 'Affiliation': 'Janssen Vaccines, Bern, Switzerland.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Walsh', 'Affiliation': 'Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Georgia D', 'Initials': 'GD', 'LastName': 'Tomaras', 'Affiliation': 'Department of Surgery and Duke Human Vaccine Institute, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Kublin', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'M Juliana', 'Initials': 'MJ', 'LastName': 'McElrath', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Galit', 'Initials': 'G', 'LastName': 'Alter', 'Affiliation': 'Ragon Institute of MGH, MIT, and Harvard, Cambridge, MA, USA.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Ferrari', 'Affiliation': 'Department of Surgery and Duke Human Vaccine Institute, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Montefiori', 'Affiliation': 'Department of Surgery and Duke Human Vaccine Institute, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Mann', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Nijs', 'Affiliation': 'Janssen Infectious Diseases, Beerse, Belgium.'}, {'ForeName': 'Katleen', 'Initials': 'K', 'LastName': 'Callewaert', 'Affiliation': 'Ragon Institute of MGH, MIT, and Harvard, Cambridge, MA, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Goepfert', 'Affiliation': 'Division of Infectious Disease, Department of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Srilatha', 'Initials': 'S', 'LastName': 'Edupuganti', 'Affiliation': 'Hope Clinic of the Emory Vaccine Center, Division of Infectious Diseases, Department of Medicine, Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Etienne', 'Initials': 'E', 'LastName': 'Karita', 'Affiliation': 'Rwanda Zambia HIV Research Group, Kigali, Rwanda.'}, {'ForeName': 'Johannes P', 'Initials': 'JP', 'LastName': 'Langedijk', 'Affiliation': 'Janssen Vaccines & Prevention, Leiden, Netherlands.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Wegmann', 'Affiliation': 'Janssen Vaccines & Prevention, Leiden, Netherlands.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Corey', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Maria G', 'Initials': 'MG', 'LastName': 'Pau', 'Affiliation': 'Janssen Vaccines & Prevention, Leiden, Netherlands.'}, {'ForeName': 'Dan H', 'Initials': 'DH', 'LastName': 'Barouch', 'Affiliation': 'Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA; Ragon Institute of MGH, MIT, and Harvard, Cambridge, MA, USA.'}, {'ForeName': 'Hanneke', 'Initials': 'H', 'LastName': 'Schuitemaker', 'Affiliation': 'Janssen Vaccines & Prevention, Leiden, Netherlands.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Tomaka', 'Affiliation': 'Janssen Research and Development, Titusville, NJ, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. HIV,['10.1016/S2352-3018(20)30229-0']
3026,32991399,Effectiveness and safety of light vegetarian diet and Qingjiang Tiaochang Recipe for functional constipation: An exploratory study protocol for randomized controlled trial.,"INTRODUCTION


Functional constipation is a chronic disease that is common in children and adults around the world. The treatments for functional constipation include diet and lifestyle interventions, medications, and surgery. The diet pattern plays an important role in the occurrence of constipation. We found in clinical practice that simple application of drugs cannot achieve long-term relief of constipation, and a large number of patients are not satisfied with the existing treatment. We have concluded that Qingjiang Tiaochang Recipe (QJTCR) and light vegetarian diet (LVD) can effectively improve constipation. However, there is no enough evidence for the description of the effect. This protocol aims at exploratorily investigating effectiveness and safety of LVD and QJTCR following a rigorous clinical trial.
METHODS AND ANALYSIS


We will recruit 90 patients to participate in this prospective, placebo-controlled, randomized trial, and exploratory study at the China-Japan Friendship Hospital, including traditional Chinese medicine group, placebo + diet group, traditional Chinese medicine + diet group. Patients in the diet intervention group must strictly abide by LVD, and the study will continue for 28 days. During the intervention period, we need to record a designed diary to assess diet quality and defecation. The primary outcomes for this clinical study were weekly complete spontaneous bowel movements. The secondary outcomes were constipation-related symptom rating scale, traditional Chinese medicine syndrome scale, and 48-hour gastrointestinal transit time, high-resolution anorectal manometry, Bristol stool score, constipation quality of life assessment scale, constipation symptoms self-assessment scale, short-chain fatty acids in feces. In addition, the study will determine the safety of the intervention.",2020,"The secondary outcomes were constipation-related symptom rating scale, traditional Chinese medicine syndrome scale, and 48-hour gastrointestinal transit time, high-resolution anorectal manometry, Bristol stool score, constipation quality of life assessment scale, constipation symptoms self-assessment scale, short-chain fatty acids in feces.","['90 patients to participate in this prospective, placebo-controlled, randomized trial, and exploratory study at the China-Japan Friendship Hospital, including traditional Chinese medicine group', 'functional constipation']","['LVD and QJTCR', 'diet intervention', 'Qingjiang Tiaochang Recipe (QJTCR) and light vegetarian diet (LVD', 'placebo + diet group, traditional Chinese medicine + diet group', 'light vegetarian diet and Qingjiang Tiaochang Recipe']","['weekly complete spontaneous bowel movements', 'constipation-related symptom rating scale, traditional Chinese medicine syndrome scale, and 48-hour gastrointestinal transit time, high-resolution anorectal manometry, Bristol stool score, constipation quality of life assessment scale, constipation symptoms self-assessment scale, short-chain fatty acids in feces', 'constipation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0178647', 'cui_str': 'Friendship'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0401146', 'cui_str': 'Constipation - functional'}]","[{'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0311164', 'cui_str': 'Vegetarian diet'}, {'cui': 'C0600194', 'cui_str': 'Recipes'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}]","[{'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0429688', 'cui_str': 'Symptom ratings'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0232484', 'cui_str': 'Gastrointestinal transit time'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0374190', 'cui_str': 'Anorectal manometry'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0281588', 'cui_str': 'Assessment of quality of life'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0036591', 'cui_str': 'Self Assessment'}, {'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}]",90.0,0.0717254,"The secondary outcomes were constipation-related symptom rating scale, traditional Chinese medicine syndrome scale, and 48-hour gastrointestinal transit time, high-resolution anorectal manometry, Bristol stool score, constipation quality of life assessment scale, constipation symptoms self-assessment scale, short-chain fatty acids in feces.","[{'ForeName': 'Xinyuan', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'School of Graduates, Beijing University of Chinese Medicine.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'School of Graduates, Beijing University of Chinese Medicine.'}, {'ForeName': 'Jialiang', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'School of Graduates, Beijing University of Chinese Medicine.'}, {'ForeName': 'Huijing', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'School of Graduates, Beijing University of Chinese Medicine.'}, {'ForeName': 'Qianqian', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Peking University China-Japan Friendship School of Clinical Medicine, Peking University.'}, {'ForeName': 'Zuohu', 'Initials': 'Z', 'LastName': 'Niu', 'Affiliation': 'School of Graduates, Beijing University of Chinese Medicine.'}, {'ForeName': 'Zhangjun', 'Initials': 'Z', 'LastName': 'Yun', 'Affiliation': 'School of Graduates, Beijing University of Chinese Medicine.'}, {'ForeName': 'Bingzhi', 'Initials': 'B', 'LastName': 'Ma', 'Affiliation': 'Department of Pharmacy, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Shunkun', 'Initials': 'S', 'LastName': 'Yao', 'Affiliation': 'Department of Gastroenterology of Traditional Chinese Medicine, China-Japan Friendship Hospital.'}]",Medicine,['10.1097/MD.0000000000021363']
3027,32991411,"Evaluation of the impact of Tacrolimus-based immunosuppression on Heidelberg liver transplant cohort (HDTACRO): Study protocol for an investigator initiated, non-interventional prospective study.","BACKGROUND


Tacrolimus-based immunosuppression has resulted in enormous improvements on liver transplantation (LTx) outcomes. However, dose adjustment and medication adherence play a key role in post-transplant treatment success. The aim of the present study is to assess the trough levels and the need for adaptation of therapeutic doses in de novo LTx patients treated with Tacrolimus in the clinical routine, without any intervention to the treatment regimen.
METHODS AND ANALYSIS


This is a pilot, prospective, exploratory, monocentric, non-interventional and non-randomized investigator-initiated study. Prospectively maintained data of 100 patients treated with various oral Tacrolimus-based immunosuppressants (Prograf or Envarsus) will be analyzed. The number of required dose adjustments of Tacrolimus formulations used in clinical routine for achieving the target trough level, Tacrolimus trough level, Tacrolimus dosing, concentration/dose ratio, routine laboratory tests, efficacy data (incl. survival, acute rejection, re-transplantation), patients therapy adherence, and infections requiring the need to reduce individual immunosuppressant dosing will be evaluated for each patient.
RESULT


This study will evaluate the trough levels and the need for adaptation of therapeutic doses in de novo LTx patients treated with Tacrolimus in the clinical routine, without any intervention to the treatment regimen.
CONCLUSION


The HDTACRO study will be the first study to systematically and prospectively evaluate various oral Tacrolimus-based immunosuppressants in de novo liver transplanted patients. If a difference between the therapy-subgroups is evident at the end of the trial, a randomized control trial will eventually be designed. Registration number: ClinicalTrials.gov: NCT04444817.",2020,"If a difference between the therapy-subgroups is evident at the end of the trial, a randomized control trial will eventually be designed.","['Heidelberg liver transplant cohort (HDTACRO', 'de novo LTx patients treated with', '100 patients treated with', 'in de novo liver transplanted patients']","['Tacrolimus-based immunosuppressants', 'various oral Tacrolimus-based immunosuppressants (Prograf or Envarsus', 'Tacrolimus-based immunosuppression', 'Tacrolimus']","['target trough level, Tacrolimus trough level, Tacrolimus dosing, concentration/dose ratio, routine laboratory tests, efficacy data', 'survival, acute rejection, re-transplantation']","[{'cui': 'C0023911', 'cui_str': 'Transplantation of liver'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0021081', 'cui_str': 'Immunosuppressant agent'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0678125', 'cui_str': 'Prograft'}, {'cui': 'C4050793', 'cui_str': 'Envarsus'}, {'cui': 'C0021079', 'cui_str': 'Immunosuppressive therapy'}]","[{'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0035015', 'cui_str': 'Rejection (Psychology)'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}]",100.0,0.0415723,"If a difference between the therapy-subgroups is evident at the end of the trial, a randomized control trial will eventually be designed.","[{'ForeName': 'Elias', 'Initials': 'E', 'LastName': 'Khajeh', 'Affiliation': 'Department of General, Visceral, and Transplantation Surgery, Heidelberg University Hospital.'}, {'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Polychronidis', 'Affiliation': 'Department of General, Visceral, and Transplantation Surgery, Heidelberg University Hospital.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Ramouz', 'Affiliation': 'Department of General, Visceral, and Transplantation Surgery, Heidelberg University Hospital.'}, {'ForeName': 'Parnian', 'Initials': 'P', 'LastName': 'Alamdari', 'Affiliation': 'Department of General, Visceral, and Transplantation Surgery, Heidelberg University Hospital.'}, {'ForeName': 'Anastasia', 'Initials': 'A', 'LastName': 'Lemekhova', 'Affiliation': 'Department of General, Visceral, and Transplantation Surgery, Heidelberg University Hospital.'}, {'ForeName': 'Melisa', 'Initials': 'M', 'LastName': 'Saracevic', 'Affiliation': 'Department of General, Visceral, and Transplantation Surgery, Heidelberg University Hospital.'}, {'ForeName': 'Sadeq', 'Initials': 'S', 'LastName': 'Ali-Hasan-Al-Saegh', 'Affiliation': 'Department of General, Visceral, and Transplantation Surgery, Heidelberg University Hospital.'}, {'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Ghamarnejad', 'Affiliation': 'Department of General, Visceral, and Transplantation Surgery, Heidelberg University Hospital.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Majlesara', 'Affiliation': 'Department of General, Visceral, and Transplantation Surgery, Heidelberg University Hospital.'}, {'ForeName': 'Sepehr', 'Initials': 'S', 'LastName': 'Abbasi Dezfouli', 'Affiliation': 'Department of General, Visceral, and Transplantation Surgery, Heidelberg University Hospital.'}, {'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Nickkholgh', 'Affiliation': 'Department of General, Visceral, and Transplantation Surgery, Heidelberg University Hospital.'}, {'ForeName': 'Karl Heinz', 'Initials': 'KH', 'LastName': 'Weiss', 'Affiliation': 'Department of Gastroenterology and Hepatology, University of Heidelberg.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Rupp', 'Affiliation': 'Department of Internal Medicine, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Arianeb', 'Initials': 'A', 'LastName': 'Mehrabi', 'Affiliation': 'Department of General, Visceral, and Transplantation Surgery, Heidelberg University Hospital.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Mieth', 'Affiliation': 'Department of General, Visceral, and Transplantation Surgery, Heidelberg University Hospital.'}]",Medicine,['10.1097/MD.0000000000022180']
3028,32992075,Intermediate versus standard-dose prophylactic anticoagulation and statin therapy versus placebo in critically-ill patients with COVID-19: Rationale and design of the INSPIRATION/INSPIRATION-S studies.,"BACKGROUND


Microvascular and macrovascular thrombotic events are among the hallmarks of coronavirus disease 2019 (COVID-19). Furthermore, the exuberant immune response is considered an important driver of pulmonary and extrapulmonary manifestations of COVID-19. The optimal management strategy to prevent thrombosis in critically-ill patients with COVID-19 remains unknown.
METHODS


The Intermediate versus Standard-dose Prophylactic anticoagulation In cRitically-ill pATIents with COVID-19: An opeN label randomized controlled trial (INSPIRATION) and INSPIRATION-statin (INSPIRATION-S) studies test two independent hypotheses within a randomized controlled trial with 2 × 2 factorial design. Hospitalized critically-ill patients with reverse transcription polymerase chain reaction confirmed COVID-19 will be randomized to intermediate-dose versus standard dose prophylactic anticoagulation. The 600 patients undergoing this randomization will be screened and if meeting the eligibility criteria, will undergo an additional double-blind stratified randomization to atorvastatin 20 mg daily versus matching placebo. The primary endpoint, for both hypotheses will be tested for superiority and includes a composite of adjudicated acute arterial thrombosis, venous thromboembolism (VTE), use of extracorporeal membrane oxygenation, or all-cause death within 30 days from enrollment. Key secondary endpoints include all-cause mortality, adjudicated VTE, and ventilator-free days. Key safety endpoints include major bleeding according to the Bleeding Academic Research Consortium definition and severe thrombocytopenia (platelet count <20,000/fL) for the anticoagulation hypothesis. In a prespecified secondary analysis for non-inferiority, the study will test for the non-inferiority of intermediate intensity versus standard dose anticoagulation for major bleeding, considering a non-inferiority margin of 1.8 based on odds ratio. Key safety endpoints for the statin hypothesis include rise in liver enzymes >3 times upper normal limit and clinically-diagnosed myopathy. The primary analyses will be performed in the modified intention-to-treat population. Results will be tested in exploratory analyses across key subgroups and in the intention-to-treat and per-protocol cohorts.
CONCLUSIONS


INSPIRATION and INSPIRATON-S studies will help address clinically-relevant questions for antithrombotic therapy and thromboinflammatory therapy in critically-ill patients with COVID-19.",2020,Hospitalized critically-ill patients with reverse transcription polymerase chain reaction confirmed COVID-19 will be randomized to intermediate-dose versus standard dose prophylactic anticoagulation.,"['critically-ill patients with COVID-19 remains unknown', '600 patients undergoing this randomization will be screened and if meeting the eligibility criteria', 'cRitically-ill pATIents with COVID-19', 'critically-ill patients with COVID-19', 'Hospitalized critically-ill patients with reverse transcription polymerase chain reaction confirmed COVID-19']","['Intermediate versus standard-dose prophylactic anticoagulation and statin therapy versus placebo', 'Prophylactic anticoagulation', 'atorvastatin 20\xa0mg daily versus matching placebo']","['major bleeding according to the Bleeding Academic Research Consortium definition and severe thrombocytopenia (platelet count <20,000/fL', 'composite of adjudicated acute arterial thrombosis, venous thromboembolism (VTE), use of extracorporeal membrane oxygenation, or all-cause death', 'cause mortality, adjudicated VTE, and ventilator-free days']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0599161', 'cui_str': 'Polymerase Chain Reaction, Reverse Transcriptase'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}]","[{'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1379773', 'cui_str': 'atorvastatin 20 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0151942', 'cui_str': 'Arterial thrombosis'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0015357', 'cui_str': 'Extracorporeal membrane oxygenation'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",600.0,0.474016,Hospitalized critically-ill patients with reverse transcription polymerase chain reaction confirmed COVID-19 will be randomized to intermediate-dose versus standard dose prophylactic anticoagulation.,"[{'ForeName': 'Behnood', 'Initials': 'B', 'LastName': 'Bikdeli', 'Affiliation': ""Cardiovascular Medicine Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA; Yale/YNHH Center for Outcomes Research & Evaluation, New Haven, CT, USA; Cardiovascular Research Foundation (CRF), New York, NY, USA. Electronic address: bbikdeli@bwh.harvard.edu.""}, {'ForeName': 'Azita H', 'Initials': 'AH', 'LastName': 'Talasaz', 'Affiliation': 'Tehran Heart Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Farid', 'Initials': 'F', 'LastName': 'Rashidi', 'Affiliation': 'Tuberclosis and Lung Diseases Research Center, Tabriz, Iran.'}, {'ForeName': 'Babak', 'Initials': 'B', 'LastName': 'Sharif-Kashani', 'Affiliation': 'Tobacoo Prevention and control Research center, National Research lnstitute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran; Lung Transplantion Research Center, Department of Cardiology, National Research Institute of Tuberculosls and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Farrokhpour', 'Affiliation': 'Firouzgar Hospital, Department of Internal Medicine, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hooman', 'Initials': 'H', 'LastName': 'Bakhshandeh', 'Affiliation': 'Rajaie Cardiovascular Medical and Research Center, Iran university of Medical sciences, Tehran, Iran.'}, {'ForeName': 'Hashem', 'Initials': 'H', 'LastName': 'Sezavar', 'Affiliation': 'Rasoul-e-Akram Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Dabbagh', 'Affiliation': 'Department of Anesthesiology, School of Medicine Anesthesiology Research Center Shahid Modarres Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad Taghi', 'Initials': 'MT', 'LastName': 'Beigmohammadi', 'Affiliation': 'Anesthesiology and Intensive Care, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Pooya', 'Initials': 'P', 'LastName': 'Payandemehr', 'Affiliation': 'Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mahdi', 'Initials': 'M', 'LastName': 'Yadollahzadeh', 'Affiliation': 'Firouzgar Hospital, Department of Internal Medicine, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Taghi', 'Initials': 'T', 'LastName': 'Riahi', 'Affiliation': 'Rasoul-e-Akram Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Khalili', 'Affiliation': 'Department of Pharmacotherapy, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Sepehr', 'Initials': 'S', 'LastName': 'Jamalkhani', 'Affiliation': 'Student Research Committee, Iran University of Medical Sciences, Tehran, Iran; Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Parisa', 'Initials': 'P', 'LastName': 'Rezaeifar', 'Affiliation': 'Tuberclosis and Lung Diseases Research Center, Tabriz, Iran.'}, {'ForeName': 'Atefeh', 'Initials': 'A', 'LastName': 'Abedini', 'Affiliation': 'Chronic Respiratory Disease Research Center, Masih Daneshvari Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Somayeh', 'Initials': 'S', 'LastName': 'Lookzadeh', 'Affiliation': 'Chronic Respiratory Disease Research Center, Masih Daneshvari Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shaghayegh', 'Initials': 'S', 'LastName': 'Shahmirzaei', 'Affiliation': 'Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ouria', 'Initials': 'O', 'LastName': 'Tahamtan', 'Affiliation': 'Tuberclosis and Lung Diseases Research Center, Tabriz, Iran.'}, {'ForeName': 'Samira', 'Initials': 'S', 'LastName': 'Matin', 'Affiliation': 'Tuberclosis and Lung Diseases Research Center, Tabriz, Iran.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Amin', 'Affiliation': 'Rajaie Cardiovascular Medical and Research Center, Iran university of Medical sciences, Tehran, Iran.'}, {'ForeName': 'Seyed Ehsan', 'Initials': 'SE', 'LastName': 'Parhizgar', 'Affiliation': 'Rajaie Cardiovascular Medical and Research Center, Iran university of Medical sciences, Tehran, Iran.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Jimenez', 'Affiliation': 'Respiratory Department, Hospital Ramón y Cajal (IRYCIS), Madrid, Spain; Medicine Department, Universidad de Alcalá (IRYCIS), Madrid, Spain; CIBER Enfermedades Respiratorias (CIBERES), Madrid, Spain.'}, {'ForeName': 'Aakriti', 'Initials': 'A', 'LastName': 'Gupta', 'Affiliation': 'Cardiovascular Research Foundation (CRF), New York, NY, USA; Division of Cardiology, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Mahesh V', 'Initials': 'MV', 'LastName': 'Madhavan', 'Affiliation': 'Cardiovascular Research Foundation (CRF), New York, NY, USA; Division of Cardiology, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Sahil A', 'Initials': 'SA', 'LastName': 'Parikh', 'Affiliation': 'Cardiovascular Research Foundation (CRF), New York, NY, USA; Division of Cardiology, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Monreal', 'Affiliation': 'Department of Internal Medicine, Hospital Germans Trias i Pujol, Badalona, Barcelona, Universidad Católica de Murcia, Murcia, Spain.'}, {'ForeName': 'Naser', 'Initials': 'N', 'LastName': 'Hadavand', 'Affiliation': 'Rajaie Cardiovascular Medical and Research Center, Iran university of Medical sciences, Tehran, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Hajighasemi', 'Affiliation': 'Tehran Heart Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Maleki', 'Affiliation': 'Rajaie Cardiovascular Medical and Research Center, Iran university of Medical sciences, Tehran, Iran.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Sadeghian', 'Affiliation': 'Tehran Heart Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Bahram', 'Initials': 'B', 'LastName': 'Mohebbi', 'Affiliation': 'Rajaie Cardiovascular Medical and Research Center, Iran university of Medical sciences, Tehran, Iran.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Piazza', 'Affiliation': ""Cardiovascular Medicine Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Ajay J', 'Initials': 'AJ', 'LastName': 'Kirtane', 'Affiliation': 'Cardiovascular Research Foundation (CRF), New York, NY, USA; Division of Cardiology, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Gregory Y H', 'Initials': 'GYH', 'LastName': 'Lip', 'Affiliation': 'Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart & Chest Hospital, Liverpool, United Kingdom; Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Harlan M', 'Initials': 'HM', 'LastName': 'Krumholz', 'Affiliation': 'Yale/YNHH Center for Outcomes Research & Evaluation, New Haven, CT, USA; Section of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, CT, USA; Department of Health Policy and Adminitration, Yale School of Public Health, New Haven, CT, USA.'}, {'ForeName': 'Samuel Z', 'Initials': 'SZ', 'LastName': 'Goldhaber', 'Affiliation': ""Cardiovascular Medicine Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Parham', 'Initials': 'P', 'LastName': 'Sadeghipour', 'Affiliation': 'Cardiovascular Intervention Research Center, Rajaie Cardiovascular, Medical, and Research Center, Iran University of Medical Sciences, Iran; Clinical Trial Center, Rajaie Cardiovascular, Medical, and Research Center, Iran University of Medical Sciences, Iran. Electronic address: psadeghipour@hotmail.com.'}]",Thrombosis research,['10.1016/j.thromres.2020.09.027']
3029,32992107,Disseminating trial results: We can have both faster and better.,,2020,,[],[],[],[],[],[],,0.0376918,,"[{'ForeName': 'Gregory E', 'Initials': 'GE', 'LastName': 'Simon', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA. Electronic address: Gregory.E.Simon@kp.org.'}, {'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'Richesson', 'Affiliation': 'Duke University School of Nursing, Durham, NC, USA.'}, {'ForeName': 'Adrian F', 'Initials': 'AF', 'LastName': 'Hernandez', 'Affiliation': 'Duke University School of Medicine, Durham, NC, USA.'}]","Healthcare (Amsterdam, Netherlands)",['10.1016/j.hjdsi.2020.100474']
3030,32992136,Improving the performance of CNN to predict the likelihood of COVID-19 using chest X-ray images with preprocessing algorithms.,"OBJECTIVE


This study aims to develop and test a new computer-aided diagnosis (CAD) scheme of chest X-ray images to detect coronavirus (COVID-19) infected pneumonia.
METHOD


CAD scheme first applies two image preprocessing steps to remove the majority of diaphragm regions, process the original image using a histogram equalization algorithm, and a bilateral low-pass filter. Then, the original image and two filtered images are used to form a pseudo color image. This image is fed into three input channels of a transfer learning-based convolutional neural network (CNN) model to classify chest X-ray images into 3 classes of COVID-19 infected pneumonia, other community-acquired no-COVID-19 infected pneumonia, and normal (non-pneumonia) cases. To build and test the CNN model, a publicly available dataset involving 8474 chest X-ray images is used, which includes 415, 5179 and 2,880 cases in three classes, respectively. Dataset is randomly divided into 3 subsets namely, training, validation, and testing with respect to the same frequency of cases in each class to train and test the CNN model.
RESULTS


The CNN-based CAD scheme yields an overall accuracy of 94.5 % (2404/2544) with a 95 % confidence interval of [0.93,0.96] in classifying 3 classes. CAD also yields 98.4 % sensitivity (124/126) and 98.0 % specificity (2371/2418) in classifying cases with and without COVID-19 infection. However, without using two preprocessing steps, CAD yields a lower classification accuracy of 88.0 % (2239/2544).
CONCLUSION


This study demonstrates that adding two image preprocessing steps and generating a pseudo color image plays an important role in developing a deep learning CAD scheme of chest X-ray images to improve accuracy in detecting COVID-19 infected pneumonia.",2020,"The CNN-based CAD scheme yields an overall accuracy of 94.5 % (2404/2544) with a 95 % confidence interval of [0.93,0.96] in classifying 3 classes.",[],[],[],[],[],[],,0.0223987,"The CNN-based CAD scheme yields an overall accuracy of 94.5 % (2404/2544) with a 95 % confidence interval of [0.93,0.96] in classifying 3 classes.","[{'ForeName': 'Morteza', 'Initials': 'M', 'LastName': 'Heidari', 'Affiliation': 'School of Electrical and Computer Engineering, University of Oklahoma, Norman, OK 73019, USA. Electronic address: Morteza.heidari@ou.edu.'}, {'ForeName': 'Seyedehnafiseh', 'Initials': 'S', 'LastName': 'Mirniaharikandehei', 'Affiliation': 'School of Electrical and Computer Engineering, University of Oklahoma, Norman, OK 73019, USA.'}, {'ForeName': 'Abolfazl Zargari', 'Initials': 'AZ', 'LastName': 'Khuzani', 'Affiliation': 'Department of Electrical and Computer Engineering, University of California Santa Cruz, Santa Cruz, CA 95064, USA.'}, {'ForeName': 'Gopichandh', 'Initials': 'G', 'LastName': 'Danala', 'Affiliation': 'School of Electrical and Computer Engineering, University of Oklahoma, Norman, OK 73019, USA.'}, {'ForeName': 'Yuchen', 'Initials': 'Y', 'LastName': 'Qiu', 'Affiliation': 'School of Electrical and Computer Engineering, University of Oklahoma, Norman, OK 73019, USA.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Zheng', 'Affiliation': 'School of Electrical and Computer Engineering, University of Oklahoma, Norman, OK 73019, USA.'}]",International journal of medical informatics,['10.1016/j.ijmedinf.2020.104284']
3031,32992151,Cost and cost-effectiveness of interim methadone treatment and patient navigation initiated in jail.,"BACKGROUND


Individuals with opioid use disorder (OUD) who are released from pre-trial detention in jail have a high risk of opioid relapse. While several interventions for OUD initiated during incarceration have been studied, few have had an economic evaluation. As part of a three-group randomized trial, we estimated the cost and cost-effectiveness of a negative urine opioid test. Detainees were assigned to interim methadone (IM) in jail with continued methadone treatment post-release with and without 3 months of post-release patient navigation (PN) compared to an enhanced treatment-as-usual group.
METHODS


We implemented a micro-costing approach from the provider's perspective to estimate the cost per participant in jail and over the 12 months post-release from jail. Economic data included jail-based and community-based service utilization, self-reported healthcare utilization and justice system involvement, and administrative arrest records. Our outcome measure is the number of participants with a negative opioid urine test at their 12-month follow-up. We calculated incremental cost-effectiveness ratios (ICERs) for intervention costs only and costs from a societal perspective.
RESULTS


The average cost of providing patient navigation services per individual beginning in jail and continuing in the community was $283. We find that IM is dominated by ETAU and IM + PN. Per additional participant with a negative opioid urine test, the ICER for IM + PN including intervention costs only is $91 and $305 including societal costs.
CONCLUSIONS


IM + PN is almost certainly the cost-effective choice from both an intervention provider and societal perspective.",2020,"Per additional participant with a negative opioid urine test, the ICER for IM + PN including intervention costs only is $91 and $305 including societal costs.
","['patient navigation initiated in jail', 'Individuals with opioid use disorder (OUD']","['interim methadone', 'methadone treatment post-release with and without 3 months of post-release patient navigation (PN) compared to an enhanced treatment-as-usual group', 'negative urine opioid test']","['incremental cost-effectiveness ratios (ICERs', 'average cost of providing patient navigation services', 'cost and cost-effectiveness', 'Cost and cost-effectiveness']","[{'cui': 'C3494323', 'cui_str': 'Patient Navigation'}, {'cui': 'C0392751', 'cui_str': 'In prison'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}]","[{'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C3494323', 'cui_str': 'Patient Navigation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C3494323', 'cui_str': 'Patient Navigation'}, {'cui': 'C0557854', 'cui_str': 'Services'}]",,0.0840355,"Per additional participant with a negative opioid urine test, the ICER for IM + PN including intervention costs only is $91 and $305 including societal costs.
","[{'ForeName': 'Gary A', 'Initials': 'GA', 'LastName': 'Zarkin', 'Affiliation': 'RTI, International, 3040 East Cornwallis Road, PO Box 12194, Research Triangle Park, NC 27709-2194, United States.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Orme', 'Affiliation': 'RTI, International, 3040 East Cornwallis Road, PO Box 12194, Research Triangle Park, NC 27709-2194, United States. Electronic address: sorme@rti.org.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Dunlap', 'Affiliation': 'RTI, International, 3040 East Cornwallis Road, PO Box 12194, Research Triangle Park, NC 27709-2194, United States.'}, {'ForeName': 'Sharon M', 'Initials': 'SM', 'LastName': 'Kelly', 'Affiliation': 'Friends Research Institute, 1040 Park Avenue Suite 103. Baltimore, MD 21201, United States.'}, {'ForeName': 'Shannon G', 'Initials': 'SG', 'LastName': 'Mitchell', 'Affiliation': 'Friends Research Institute, 1040 Park Avenue Suite 103. Baltimore, MD 21201, United States.'}, {'ForeName': 'Kevin E', 'Initials': 'KE', 'LastName': ""O'Grady"", 'Affiliation': 'Department of Psychology, University of Maryland, College Park, 4094 Campus Drive, College Park, MD 20742, United States.'}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Schwartz', 'Affiliation': 'Friends Research Institute, 1040 Park Avenue Suite 103. Baltimore, MD 21201, United States.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108292']
3032,32992159,Is directed open-glottis pushing more effective than directed closed-glottis pushing during the second stage of labor? A pragmatic randomized trial - the EOLE study.,"OBJECTIVE


To compare the effectiveness of directed open-glottis and directed closed-glottis pushing.
DESIGN


Pragmatic, randomised, controlled, non-blinded superiority study.
SETTINGS


Four French hospitals between July 2015 and June 2017 (2 academic hospitals and 2 general hospitals).
PARTICIPANTS


250 women in labour who had undergone standardised training in the two types of pushing with a singleton fetus in cephalic presentation at term (≥37 weeks) were included by midwives and randomised; 125 were allocated to each group. The exclusion criteria were previous caesarean birth or fetal heart rate anomaly. Participants were randomised during labour, after a cervical dilation ≥ 7 cm.
INTERVENTIONS


In the intervention group, open-glottis pushing was defined as a prolonged exhalation contracting the abdominal muscles (pulling the stomach in) to help move the fetus down the birth canal. Closed-glottis pushing was defined as Valsalva pushing.
MEASUREMENTS


The principal outcome was ""effectiveness of pushing"" defined as a spontaneous birth without any episiotomy, second-, third-, or fourth-degree perineal lesion. The results in our intention-to-treat analysis are reported as crude relative risks (RR) with their 95% confidence intervals. A multivariable analysis was used to take the relevant prognostic and confounding factors into account and obtain an adjusted relative risk (aRR).
FINDINGS


In our intention-to-treat analysis, most characteristics were similar across groups including epidural analgesia (>95% in each group). The mean duration of the expulsion phase was longer among the open-glottis group (24.4 min ± 17.4 vs. 18.0 min ± 15.0, p=0.002). The two groups did not appear to differ in the effectiveness of their pushing (48.0% in the open-glottis group versus 55.2% in the closed-glottis group, for an adjusted relative risk (aRR) of 0.92, 95% confidence interval (CI) 0.74-1.14) or in their risk of instrumental birth (aRR 0.97, 95%CI 0.85-1.10).
KEY CONCLUSIONS


In maternity units with a high rate of epidural analgesia, the effectiveness of the type of directed pushing does not appear to differ between the open- and closed-glottis groups.
IMPLICATIONS FOR PRACTICE


If directed pushing is necessary, women should be able to choose the type of directed pushing they prefer to use during birth. Professionals must therefore be trained in both types so that they can adequately support women as they give birth.",2020,"The two groups did not appear to differ in the effectiveness of their pushing (48.0% in the open-glottis group versus 55.2% in the closed-glottis group, for an adjusted relative risk (aRR) of 0.92, 95% confidence interval (CI) 0.74-1.14) or in their risk of instrumental birth (aRR 0.97, 95%CI 0.85-1.10).
","['Four French hospitals between July 2015 and June 2017 (2 academic hospitals and 2 general hospitals', '250 women in labour who had undergone standardised training in the two types of pushing with a singleton fetus in cephalic presentation at term (≥37 weeks) were included by midwives and randomised; 125 were allocated to each group']",['directed open-glottis and directed closed-glottis pushing'],"['mean duration of the expulsion phase', 'effectiveness of pushing"" defined as a spontaneous birth without any episiotomy, second-, third-, or fourth-degree perineal lesion', 'effectiveness of their pushing', 'epidural analgesia', 'caesarean birth or fetal heart rate anomaly']","[{'cui': 'C0376246', 'cui_str': 'French language'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0580841', 'cui_str': 'Does push'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0205096', 'cui_str': 'Cephalic'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0026083', 'cui_str': 'Professional midwife'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0017681', 'cui_str': 'Glottis structure'}, {'cui': 'C0587267', 'cui_str': 'Closed'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1293107', 'cui_str': 'Expulsion'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0580841', 'cui_str': 'Does push'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0014586', 'cui_str': 'Episiotomy'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0031066', 'cui_str': 'Perineal'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0002769', 'cui_str': 'Epidural analgesia'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0018811', 'cui_str': 'Fetal heart rate'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}]",250.0,0.172721,"The two groups did not appear to differ in the effectiveness of their pushing (48.0% in the open-glottis group versus 55.2% in the closed-glottis group, for an adjusted relative risk (aRR) of 0.92, 95% confidence interval (CI) 0.74-1.14) or in their risk of instrumental birth (aRR 0.97, 95%CI 0.85-1.10).
","[{'ForeName': 'Chloé', 'Initials': 'C', 'LastName': 'Barasinski', 'Affiliation': 'Université Clermont Auvergne, CHU, CNRS, SIGMA Clermont, Institut Pascal, F-63000, CLERMONT-FERRAND, France. Electronic address: cbarasinski@chu-clermontferrand.fr.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Debost-Legrand', 'Affiliation': ""Université Clermont Auvergne, CHU, CNRS, SIGMA Clermont, Institut Pascal, F-63000, CLERMONT-FERRAND, France; Réseau de Santé en Périnatalité d'Auvergne, F-63000, Clermont-Ferrand, France.""}, {'ForeName': 'Françoise', 'Initials': 'F', 'LastName': 'Vendittelli', 'Affiliation': ""Université Clermont Auvergne, CHU, CNRS, SIGMA Clermont, Institut Pascal, F-63000, CLERMONT-FERRAND, France; Réseau de Santé en Périnatalité d'Auvergne, F-63000, Clermont-Ferrand, France; AUDIPOG (Association des Utilisateurs de Dossiers Informatisés en Pédiatrie, Obstétrique et Gynécologie), RTH Laennec Medical University, 7 rue Guillaume Paradin, 69372, Lyon Cedex 08, France.""}]",Midwifery,['10.1016/j.midw.2020.102843']
3033,32992184,Immediate Effects of Plantar Vibration on Fall Risk and Postural Stability in Stroke Patients: A Randomized Controlled Trial.,"BACKGROUND


Local vibration can improve balance problems of individuals with stroke when applied to the plantar region.
AIMS


This study aimed to determine the immediate effect of local vibration applied to the plantar region on fall risk and postural stability in patients with stroke.
STUDY DESIGN


Randomized controlled study.
METHODS


30 patients (23 male,7 female) with stroke were randomized to either vibration (n = 15; 58.47 ± 8.23 years) or control (n = 15; 58.27 ± 9.50 years) groups. Before and after the intervention, the patients were evaluated using a Biodex Balance System. Local vibration was applied to the plantar region of two feet in the supine position using a vibration device for a total of 15 min to the individuals in the vibration group. While the patients in the placebo group were in the supine position, the device was brought into contact and no vibration was applied to the plantar region of two feet for 15 min.
RESULTS


While significant improvements were observed in the postural stability and fall risk of the vibration group (p < 0.05), no significant change was observed in the placebo group (p > 0.05). Furthermore, significant improvements occurred in the SD values of the postural stability expressing postural oscillation in the vibration group (p < 0.05).
CONCLUSION


As a result of local vibration applied to the plantar region, immediate (within 5 min) significant improvements in postural stability and fall risk values were detected.",2020,"While significant improvements were observed in the postural stability and fall risk of the vibration group (p < 0.05), no significant change was observed in the placebo group (p > 0.05).","['individuals with stroke', '30 patients (23 male,7 female) with stroke', 'Stroke Patients', 'patients with stroke']","['placebo', 'local vibration', 'Plantar Vibration', 'vibration']","['fall risk and postural stability', 'SD values of the postural stability expressing postural oscillation', 'postural stability and fall risk', 'postural stability and fall risk values', 'Fall Risk and Postural Stability']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}]","[{'cui': 'C1268740', 'cui_str': 'At risk for falls'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}]",30.0,0.0194722,"While significant improvements were observed in the postural stability and fall risk of the vibration group (p < 0.05), no significant change was observed in the placebo group (p > 0.05).","[{'ForeName': 'Birol', 'Initials': 'B', 'LastName': 'Önal', 'Affiliation': 'Hacettepe University, Faculty of Physical Therapy and Rehabilitation, Ankara, Turkey. Electronic address: fztbirolonal@gmail.com.'}, {'ForeName': 'Gülten', 'Initials': 'G', 'LastName': 'Karaca', 'Affiliation': 'Department of Physical Therapy and Rehabilitation, Ankara Memorial Hospital, Ankara, Turkey. Electronic address: gulten2013@yahoo.com.'}, {'ForeName': 'Meral', 'Initials': 'M', 'LastName': 'Sertel', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Kırıkkale University Faculty of Health Sciences, Kırıkkale, Turkey. Electronic address: fzt_meralaksehir@hotmail.com.'}]",Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association,['10.1016/j.jstrokecerebrovasdis.2020.105324']
3034,32996172,"Application of enamel matrix derivative in conjunction with non-surgical therapy for treatment of moderate to severe periodontitis: A 12-month, randomized prospective, multicenter study.","BACKGROUND


Treatment of periodontitis aims to halt progressive bone and attachment loss and regenerate periodontal structures. In this study, the effect of using an enamel matrix derivative (EMD) as an adjunct to non-surgical periodontal therapy (test) versus non-surgical therapy alone (control) was evaluated.
METHODS


A prospective, split-mouth, multi-center study evaluated scaling and root planing (SRP) with and without EMD in 51 patients presenting with moderate to severe periodontitis (PPD = 5 to 8 mm) in at least 2 pockets per contralateral quadrants within the same arch. The primary outcome variable was change in clinical attachment level (CAL) after 12 months. Secondary variables included probing pocket depth (PPD), bleeding on probing (BoP), gingival margin level, dentin hypersensitivity, and percent of pockets converted to sites no longer requiring surgical treatment.
RESULTS


CAL changed significantly (P  < 0.001) from baseline to 12 months for both treatment modalities (test = -2.2 ± 1.5 mm versus control = -2.1 ± 1.3 mm) and similarly for PPD; the difference between groups was not significant. A significant difference, favoring test conditions, was observed in percentage of both healthy PPDs (pockets < 5 mm) and converted pockets (sites no longer requiring surgical treatment); 79.8% of test versus 65.9% of control sites. BoP decreased significantly more (P < 0.05) in test sites (BoP at 17.8% test versus 23.1% control).
CONCLUSIONS


Both test and control treatments resulted in significant improvements in CAL and PPD. The adjunct use of EMD with SRP resulted in significantly greater improvements in overall periodontal health with less frequent BoP and a higher number of healthy PPDs.",2020,The adjunct use of EMD with SRP resulted in significantly greater improvements in overall periodontal health with less frequent BoP and a higher number of healthy PPDs.,"['51 patients presenting with moderate to severe periodontitis (PPD = 5 to 8 mm) in at least 2 pockets per contralateral quadrants within the same arch', 'moderate to severe periodontitis']","['EMD with SRP', 'scaling and root planing (SRP) with and without EMD', 'enamel matrix derivative (EMD', 'enamel matrix derivative in conjunction with non-surgical therapy', 'surgical periodontal therapy (test) vs. non-surgical therapy alone (control']","['percentage of both healthy PPDs', 'clinical attachment level (CAL', 'probing pocket depth (PPD), bleeding on probing (BoP), gingival margin level, dentin hypersensitivity, and percent of pockets converted to sites no longer requiring surgical treatment', 'BoP', 'CAL and PPD', 'overall periodontal health']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0441988', 'cui_str': 'Contralateral'}, {'cui': 'C0230467', 'cui_str': 'Structure of arch of foot'}]","[{'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C0243072', 'cui_str': 'derivatives'}, {'cui': 'C0085287', 'cui_str': 'Root planing of tooth'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0034131', 'cui_str': 'Purified Protein Derivative of Tuberculin'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0011432', 'cui_str': 'Sensitive dentin'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",51.0,0.0524034,The adjunct use of EMD with SRP resulted in significantly greater improvements in overall periodontal health with less frequent BoP and a higher number of healthy PPDs.,"[{'ForeName': 'Rachel A', 'Initials': 'RA', 'LastName': 'Schallhorn', 'Affiliation': 'Private practice, Aurora, Colorado, USA.'}, {'ForeName': 'Pamela K', 'Initials': 'PK', 'LastName': 'McClain', 'Affiliation': 'Private practice, Aurora, Colorado, USA.'}, {'ForeName': 'Veronique', 'Initials': 'V', 'LastName': 'Benhamou', 'Affiliation': 'Private practice, Montreal, Quebec, Canada.'}, {'ForeName': 'Jennifer H', 'Initials': 'JH', 'LastName': 'Doobrow', 'Affiliation': 'Private practice, Cullman, Alabama, USA.'}, {'ForeName': 'H Michelle', 'Initials': 'HM', 'LastName': 'Grandin', 'Affiliation': 'Alfred E. Mann Institute, University of Southern California, Los Angeles, California, USA.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Kasaj', 'Affiliation': 'Department of Periodontology and Operative Dentistry, University Medical Center of the Johannes Gutenberg University Mainz, Mainz, Germany.'}]",Journal of periodontology,['10.1002/JPER.19-0579']
3035,32997437,Comparison of conventional chest physiotherapy and oscillatory positive expiratory pressure therapy in primary ciliary dyskinesia.,"BACKGROUND


Chest physiotherapy (CP) is a recommended treatment modality in primary ciliary dyskinesia (PCD).
OBJECTIVE


Primary aim was to compare the efficacy and safety of the conventional chest physiotherapy (CCP) and oscillatory positive expiratory pressure therapy (OPEPT). Secondary aims were to compare the exacerbation rate, time until the first exacerbation, patient compliance and comfort between the two CP methods.
METHODS


This is a 6 month randomized, controlled crossover trial. Patients >6 years of age with PCD were randomized into two groups, first group was assigned to OPEPT (Acapella®) for 3 months while second group was assigned to CCP. Groups were crossed over to the other modality after a 15-day washout period. Pulmonary function tests (PFTs) and compliance were monitored by monthly clinic visits.
RESULTS


There was a significant increase in FEV 1  , FEF 25-75  , and PEF values (p = .018, p = .020, and p = .016, respectively) in the OPEPT group and in FVC values (p = .007) in CCP group compared to baseline. However PFT increase at 3rd month was not superior to each other with both physiotherapy methods. Median acute pulmonary exacerbation rate and time period until the first exacerbation were similar in both groups (p = .821, p = .092, respectively). Comfort and effectiveness of OPEPT was higher than CCP according to patients (p = .029 and p = .042, respectively). There were no adverse effects with either therapy.
CONCLUSIONS


OPEPT was as effective as CCP in PCD patients. OPEPT was more comfortable and effective than CCP according to patients. OPEPT might be an efficient alternative method for airway cleareance in PCD patients.",2020,"Comfort and effectiveness of OPEPT was higher than CCP according to patients (p=0.029 and p=0.042, respectively).","['primary ciliary dyskinesia (PCD', 'Patients >6 years of age with PCD', 'Primary Ciliary Dyskinesia', 'PCD patients']","['CCP', 'Chest physiotherapy (CP', 'OPEPT (Acapella®', 'OPEPT', 'Conventional Chest Physiotherapy and Oscillatory Positive Pressure Therapy', 'conventional chest physiotherapy (CCP) and oscillatory positive expiratory pressure therapy (OPEPT']","['Pulmonary function tests (PFT) and compliance', 'FVC values', 'efficacy and safety', 'Median acute pulmonary exacerbation rate and time period until the first exacerbation', 'adverse effects', 'Comfort and effectiveness of OPEPT', 'exacerbation rate, time until the first exacerbation, patient compliance and comfort', 'FEV']","[{'cui': 'C4551720', 'cui_str': 'Primary ciliary dyskinesia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0199467', 'cui_str': 'Physiotherapy of chest'}, {'cui': 'C0419023', 'cui_str': 'Positive end expiratory pressure ventilation therapy, initiation and management'}, {'cui': 'C0454517', 'cui_str': 'Positive pressure therapy'}]","[{'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C3714541', 'cui_str': 'Forced vital capacity'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C1948053', 'cui_str': 'Time periods'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0419023', 'cui_str': 'Positive end expiratory pressure ventilation therapy, initiation and management'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1321605', 'cui_str': 'Compliance behavior'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}]",,0.0464906,"Comfort and effectiveness of OPEPT was higher than CCP according to patients (p=0.029 and p=0.042, respectively).","[{'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Bingol', 'Affiliation': 'Division of Pediatrics, School of Medicine, Marmara University, Istanbul, Turkey.'}, {'ForeName': 'Yasemin', 'Initials': 'Y', 'LastName': 'Gokdemir', 'Affiliation': 'Division of Pediatric Pulmonology, School of Medicine, Marmara University, Istanbul, Turkey.'}, {'ForeName': 'Cansu', 'Initials': 'C', 'LastName': 'Yilmaz-Yegit', 'Affiliation': 'Division of Pediatric Pulmonology, School of Medicine, Marmara University, Istanbul, Turkey.'}, {'ForeName': 'Pinar', 'Initials': 'P', 'LastName': 'Ergenekon', 'Affiliation': 'Division of Pediatric Pulmonology, School of Medicine, Marmara University, Istanbul, Turkey.'}, {'ForeName': 'Emine', 'Initials': 'E', 'LastName': 'Atag', 'Affiliation': 'Division of Pediatric Pulmonology, School of Medicine, Marmara University, Istanbul, Turkey.'}, {'ForeName': 'Nilay', 'Initials': 'N', 'LastName': 'Bas Ikizoglu', 'Affiliation': 'Division of Pediatric Pulmonology, School of Medicine, Marmara University, Istanbul, Turkey.'}, {'ForeName': 'Ela', 'Initials': 'E', 'LastName': 'Erdem Eralp', 'Affiliation': 'Division of Pediatric Pulmonology, School of Medicine, Marmara University, Istanbul, Turkey.'}, {'ForeName': 'Ayca', 'Initials': 'A', 'LastName': 'Evkaya', 'Affiliation': 'Division of Physiotheraphy and Rehabilitation, School of Health Sciences, Maltepe University, Istanbul, Turkey.'}, {'ForeName': 'Kardelen', 'Initials': 'K', 'LastName': 'Gencer', 'Affiliation': 'Division of Physical Medicine and Rehabilitation, School of Medicine, Marmara University, Istanbul, Turkey.'}, {'ForeName': 'Evrim K', 'Initials': 'EK', 'LastName': 'Saygi', 'Affiliation': 'Division of Physical Medicine and Rehabilitation, School of Medicine, Marmara University, Istanbul, Turkey.'}, {'ForeName': 'Fazilet', 'Initials': 'F', 'LastName': 'Karakoc', 'Affiliation': 'Division of Pediatric Pulmonology, School of Medicine, Marmara University, Istanbul, Turkey.'}, {'ForeName': 'Refika', 'Initials': 'R', 'LastName': 'Ersu', 'Affiliation': 'Division of Pediatric Pulmonology, School of Medicine, Marmara University, Istanbul, Turkey.'}, {'ForeName': 'Bulent', 'Initials': 'B', 'LastName': 'Karadag', 'Affiliation': 'Division of Pediatric Pulmonology, School of Medicine, Marmara University, Istanbul, Turkey.'}]",Pediatric pulmonology,['10.1002/ppul.25099']
3036,33001144,"Association of Oxymetazoline Hydrochloride, 0.1%, Solution Administration With Visual Field in Acquired Ptosis: A Pooled Analysis of 2 Randomized Clinical Trials.","Importance


Treatment of acquired blepharoptosis (ptosis) is currently limited to surgical intervention.
Objective


To examine the efficacy and safety of oxymetazoline hydrochloride, 0.1%, ophthalmic solution (oxymetazoline, 0.1%) in participants with acquired ptosis.
Design, Setting, and Participants


This pooled analysis of 2 randomized, double-masked, placebo-controlled, multicenter phase 3 clinical trials included participants 9 years and older with acquired ptosis and superior visual field deficit. The 2 studies were conducted across 16 and 27 sites in the United States. Patients were enrolled from May 2015 to April 2019. Analyses for the individual trials were initiated after database lock and completed on September 6, 2017, and May 16, 2019. Pooled analysis was completed on August 25, 2019.
Interventions


Participants (randomized 2:1) received oxymetazoline, 0.1%, or vehicle, self-administered as a single drop per eye, once daily, for 42 days.
Main Outcomes and Measures


The primary efficacy end point was change from baseline in the number of points seen on the Leicester Peripheral Field Test, a test to detect superior visual field deficits due to ptosis, on days 1 (6 hours after instillation) and 14 (2 hours after instillation). The secondary end point, change from baseline in marginal reflex distance 1, was assessed at the same time points.
Results


In total, 304 participants were enrolled (mean [SD] age, 63.8 [13.8] years; 222 women [73%]). Overall, 97.5% (198 of 203) of participants receiving oxymetazoline, 0.1%, and 97.0% (98 of 101) of participants receiving vehicle completed the studies. Oxymetazoline, 0.1%, was associated with a significant increase in the mean (SD) number of points seen on the Leicester Peripheral Field Test vs vehicle (day 1: 5.9 [6.4] vs 1.8 [4.1]; mean difference, 4.07 [95% CI, 2.74-5.39]; P < .001; day 14: 7.1 [5.9] vs 2.4 [5.5]; mean difference, 4.74 [95% CI, 3.43-6.04]; P < .001). Oxymetazoline, 0.1%, also was associated with a significant increase in marginal reflex distance 1 from baseline (mean [SD]: day 1: 0.96 [0.89] mm vs 0.50 [0.81] mm; mean difference, 0.47 mm [95% CI, 0.27-0.67]; P < .001; day 14: 1.16 [0.87] mm vs 0.50 [0.80] mm; mean difference, 0.67 mm [95% CI, 0.46-0.88]; P < .001). Treatment-emergent adverse events (TEAEs) occurred in 31.0% (63 of 203) of participants receiving oxymetazoline, 0.1%, and 35.6% (36 of 101) of participants receiving vehicle. Among participants receiving oxymetazoline, 0.1%, with a TEAE, 81% (51 of 63) had a maximum TEAE intensity of mild, and 62% (39 of 63) had no TEAE suspected of being treatment related.
Conclusions and Relevance


Oxymetazoline, 0.1%, was associated with positive outcomes and was well tolerated in phase 3 trials after instillation at days 1 and 14, demonstrating its potential promise for the treatment of acquired ptosis, although further study is needed to elucidate the clinical relevance of these findings beyond 6 weeks.",2020,"Treatment-emergent adverse events (TEAEs) occurred in 31.0% (63 of 203) of participants receiving oxymetazoline, 0.1%, and 35.6% (36 of 101) of participants receiving vehicle.","['participants with acquired ptosis', 'in Acquired Ptosis', 'acquired blepharoptosis (ptosis', 'participants 9 years and older with acquired ptosis and superior visual field deficit', 'Patients were enrolled from May 2015 to April 2019', '304 participants were enrolled (mean [SD] age, 63.8 [13.8] years; 222 women [73']","['Oxymetazoline Hydrochloride, 0.1%, Solution Administration With Visual Field', 'Oxymetazoline', 'oxymetazoline, 0.1%, or vehicle, self', 'oxymetazoline hydrochloride, 0.1%, ophthalmic solution (oxymetazoline', 'placebo', 'oxymetazoline']","['efficacy and safety', 'marginal reflex distance', 'maximum TEAE intensity of mild', 'mean (SD) number of points seen']","[{'cui': 'C0439661', 'cui_str': 'Acquired'}, {'cui': 'C0005745', 'cui_str': 'Ptosis of eyelid'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0042826', 'cui_str': 'Visual field'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517561', 'cui_str': '13.8'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0357797', 'cui_str': 'Oxymetazoline hydrochloride'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0042826', 'cui_str': 'Visual field'}, {'cui': 'C0030071', 'cui_str': 'Oxymetazoline'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0015399', 'cui_str': 'Eye drops'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1827217', 'cui_str': 'Margin reflex distance'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449956', 'cui_str': 'Number of points'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}]",304.0,0.627602,"Treatment-emergent adverse events (TEAEs) occurred in 31.0% (63 of 203) of participants receiving oxymetazoline, 0.1%, and 35.6% (36 of 101) of participants receiving vehicle.","[{'ForeName': 'Charles B', 'Initials': 'CB', 'LastName': 'Slonim', 'Affiliation': 'Department of Ophthalmology, University of South Florida Morsani College of Medicine, Tampa.'}, {'ForeName': 'Shane', 'Initials': 'S', 'LastName': 'Foster', 'Affiliation': 'Athens Eye Care, Athens, Ohio.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Jaros', 'Affiliation': 'Summit Analytical, Denver, Colorado.'}, {'ForeName': 'Shane R', 'Initials': 'SR', 'LastName': 'Kannarr', 'Affiliation': 'Kannarr Eye Care, Pittsburg, Kansas.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Korenfeld', 'Affiliation': 'Comprehensive Eye Care Ltd, Washington, Missouri.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Smyth-Medina', 'Affiliation': 'North Valley Eye Medical Group, Mission Hills, California.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Wirta', 'Affiliation': 'Aesthetic Eye Care Institute & Eye Research Foundation, Newport Beach, California.'}]",JAMA ophthalmology,['10.1001/jamaophthalmol.2020.3812']
3037,33001159,"Short-term Efficacy and Safety of Topical β-Blockers (Timolol Maleate Ophthalmic Solution, 0.5%) in Acute Migraine: A Randomized Crossover Trial.","Importance


Oral β-blockers used for the prevention of migraine headache are not effective for the treatment of acute pain. Small case series have suggested that topically applied β-blockers may be useful in the management of acute migraine pain, warranting evaluation with randomized clinical trials.
Objective


To evaluate the short-term efficacy and safety of topically applied timolol maleate ophthalmic solution, 0.5%, compared with topically applied placebo eyedrops in the treatment of acute migraine attacks.
Design, Setting, and Participants


In this randomized, masked placebo-controlled crossover trial conducted from May 27, 2015, to August 28, 2017, 50 patients with migraine were randomized to receive either timolol eyedrops, 0.5%, or a placebo eyedrop (carboxymethyl cellulose, 0.5%). After a 3-month treatment period, patients completed a 1-month washout period and were crossed over to receive the opposite treatment for a final 3 months. Analysis was performed on a modified intent-to-treat basis.
Intervention


After random assignment, patients were instructed to use 1 drop of the assigned medication in each eye at the earliest onset of migraine.
Main Outcomes and Measures


The main outcome measure was reduction in pain score with treatment. The primary end point was reduction of pain score by 4 points, or to zero, 20 minutes after instillation of the eyedrop.
Results


Of the 50 patients, 42 (84%) were females and the mean (SD) age was 27.3 (11.3) years. Of a total of 619 migraine attacks, 284 (46%) were treated with timolol, 271 (44%) were treated with the placebo, and 64 (10%) occurred during the washout period when no study medications were used. Seven patients (14%) withdrew after randomization. A total of 233 of the timolol-treated migraine attacks (82%) were associated with a reduction in pain score by 4 points, or to zero, at 20 minutes compared with 38 of the placebo-treated attacks (14%), with a difference of 68 percentage points (95% CI, 62-74 percentage points). A generalized estimating equation analysis revealed that pain score reduction at 20 minutes was greater in the timolol group compared with the placebo group by a mean (SE) of 4.63 points (0.34) (P < .001).
Conclusions and Relevance


This randomized crossover trial supports consideration of timolol eyedrops in the acute treatment of migraine. Further research is warranted to determine if the improvements observed are sustained for a longer follow-up and with larger groups.
Trial Registration


CTRI/2015/05/005829, UTN: U1111-1167-6439.",2020,"A generalized estimating equation analysis revealed that pain score reduction at 20 minutes was greater in the timolol group compared with the placebo group by a mean (SE) of 4.63 points (0.34) (P < .001).
","['Acute Migraine', '50 patients, 42 (84%) were females and the mean (SD) age was 27.3 (11.3) years', 'acute migraine attacks', 'May 27, 2015, to August 28, 2017, 50 patients with migraine']","['CTRI/2015/05/005829, UTN', 'timolol eyedrops', 'timolol', 'placebo eyedrop (carboxymethyl cellulose', 'placebo', 'Topical β-Blockers (Timolol Maleate Ophthalmic Solution', 'timolol maleate ophthalmic solution', 'placebo eyedrops']","['reduction of pain score', 'pain score', 'migraine attacks', 'pain score reduction']","[{'cui': 'C1740836', 'cui_str': 'Acute migraine'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}]","[{'cui': 'C0040233', 'cui_str': 'Timolol'}, {'cui': 'C0015399', 'cui_str': 'Eye drops'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0007068', 'cui_str': 'Carboxymethylcellulose'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0087093', 'cui_str': 'Timolol maleate'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0004063', 'cui_str': 'Assault'}]",50.0,0.344101,"A generalized estimating equation analysis revealed that pain score reduction at 20 minutes was greater in the timolol group compared with the placebo group by a mean (SE) of 4.63 points (0.34) (P < .001).
","[{'ForeName': 'Abraham', 'Initials': 'A', 'LastName': 'Kurian', 'Affiliation': 'Chaithanya Eye Hospital and Research Institute, Kesavadasapuram, Trivandrum, Kerala, India.'}, {'ForeName': 'Iodine', 'Initials': 'I', 'LastName': 'Reghunadhan', 'Affiliation': 'Chaithanya Eye Hospital and Research Institute, Kesavadasapuram, Trivandrum, Kerala, India.'}, {'ForeName': 'Pratibha', 'Initials': 'P', 'LastName': 'Thilak', 'Affiliation': 'Chaithanya Eye Hospital and Research Institute, Tiruvalla, Kerala, India.'}, {'ForeName': 'Indulekha', 'Initials': 'I', 'LastName': 'Soman', 'Affiliation': 'Chaithanya Eye Hospital and Research Institute, Kesavadasapuram, Trivandrum, Kerala, India.'}, {'ForeName': 'Unnikrishnan', 'Initials': 'U', 'LastName': 'Nair', 'Affiliation': 'Chaithanya Eye Hospital and Research Institute, Kesavadasapuram, Trivandrum, Kerala, India.'}]",JAMA ophthalmology,['10.1001/jamaophthalmol.2020.3676']
3038,33001210,Safety and Efficacy of Low-Dose Atropine Eyedrops for the Treatment of Myopia Progression in Chinese Children: A Randomized Clinical Trial.,"Importance


Because studies have suggested that atropine might slow the progression of myopia in children, randomized clinical trials are warranted to understand this potential causal relationship.
Objective


To evaluate the efficacy and safety of atropine, 0.01%, eyedrops on slowing myopia progression and axial elongation in Chinese children.
Design, Setting, and Participants


This was a randomized, placebo-controlled, double-masked study. A total of 220 children aged 6 to 12 years with myopia of -1.00 D to -6.00 D in both eyes were enrolled between April 2018 and July 2018 at Beijing Tongren Hospital, Beijing, China. Cycloplegic refraction and axial length were measured at baseline, 6 months, and 12 months. Adverse events were also recorded.
Interventions


Patients were randomly assigned in a 1:1 ratio to atropine, 0.01%, or placebo groups to be administered once nightly to both eyes for 1 year.
Main Outcomes and Measures


Mean changes and percentage differences in myopia progression and axial elongation between atropine, 0.01%, or placebo groups.
Results


Of 220 participants, 103 were girls (46.8%), and the mean (SD) age was 9.64 (1.68) years. The mean (SD) baseline refractive error and axial length were -2.58 (1.39) D and 24.59 (0.87) mm. Follow-up at 1 year included 76 children (69%) and 83 children (75%) allocated into the atropine, 0.01%, and placebo groups, respectively, when mean myopia progression was -0.49 (0.42) D and -0.76 (0.50) D in the atropine, 0.01%, and placebo groups (mean difference, 0.26 D; 95% CI, 0.12-0.41 D; P < .001), with a relative reduction of 34.2% in myopia progression. The mean (SD) axial elongation in the atropine, 0.01%, group was 0.32 (0.19) mm compared with 0.41 (0.19) mm in the placebo group (mean difference, 0.09 mm; 95% CI, 0.03-0.15 mm; P = .004), with relative reduction of 22.0% in axial elongation. Fifty-one percent and 13.2% of children progressed by at least 0.50 D and 1.00 D in the atropine, 0.01%, group, compared with 69.9% and 34.9% in the placebo group. No serious adverse events related to atropine were reported.
Conclusions and Relevance


While the clinical relevance of the results cannot be determined from this trial, these 1-year results, limited by approximately 70% follow-up, suggest that atropine, 0.01%, eyedrops can slow myopia progression and axial elongation in children and warrant future studies to determine longer-term results and potential effects on slowing sight-threatening pathologic changes later in life.
Trial Registration


http://www.chictr.org.cn Identifier: ChiCTR-IOR-17013898.",2020,"The mean (SD) axial elongation in the atropine, 0.01%, group was 0.32 (0.19) mm compared with 0.41 (0.19) mm in the placebo group (mean difference, 0.09 mm; 95% CI, 0.03-0.15 mm; P = .004), with relative reduction of 22.0% in axial elongation.","['220 participants, 103 were girls (46.8%), and the mean (SD) age was 9.64 (1.68) years', 'Chinese Children', 'were enrolled between April 2018 and July 2018 at Beijing Tongren Hospital, Beijing, China', '220 children aged 6 to 12 years with myopia of -1.00 D to -6.00 D in both eyes', 'Chinese children']","['Low-Dose Atropine Eyedrops', 'eyedrops', 'http://www.chictr.org.cn', 'placebo', 'atropine']","['mean (SD) axial elongation', 'Cycloplegic refraction and axial length', 'Safety and Efficacy', 'efficacy and safety', 'Adverse events', 'slowing myopia progression and axial elongation', 'myopia progression and axial elongation', 'mean (SD) baseline refractive error and axial length', 'mean myopia progression', 'Myopia Progression']","[{'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C5191337', 'cui_str': '1.68'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C4042832', 'cui_str': 'Peking'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0027092', 'cui_str': 'Myopia'}, {'cui': 'C0229118', 'cui_str': 'Structure of both eyes'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0004259', 'cui_str': 'Atropine'}, {'cui': 'C0015399', 'cui_str': 'Eye drops'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205131', 'cui_str': 'Axial'}, {'cui': 'C0855713', 'cui_str': 'Cycloplegic refraction'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0027092', 'cui_str': 'Myopia'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0034951', 'cui_str': 'Disorder of refraction'}]",220.0,0.704505,"The mean (SD) axial elongation in the atropine, 0.01%, group was 0.32 (0.19) mm compared with 0.41 (0.19) mm in the placebo group (mean difference, 0.09 mm; 95% CI, 0.03-0.15 mm; P = .004), with relative reduction of 22.0% in axial elongation.","[{'ForeName': 'Shifei', 'Initials': 'S', 'LastName': 'Wei', 'Affiliation': 'Beijing Tongren Eye Center, Beijing Tongren Hospital, Beijing Ophthalmology and Visual Science Key Lab, Beijing Institute of Ophthalmology, Capital Medical University, Beijing, China.'}, {'ForeName': 'Shi-Ming', 'Initials': 'SM', 'LastName': 'Li', 'Affiliation': 'Beijing Tongren Eye Center, Beijing Tongren Hospital, Beijing Ophthalmology and Visual Science Key Lab, Beijing Institute of Ophthalmology, Capital Medical University, Beijing, China.'}, {'ForeName': 'Wenzai', 'Initials': 'W', 'LastName': 'An', 'Affiliation': 'Beijing Tongren Eye Center, Beijing Tongren Hospital, Beijing Ophthalmology and Visual Science Key Lab, Beijing Institute of Ophthalmology, Capital Medical University, Beijing, China.'}, {'ForeName': 'Jialing', 'Initials': 'J', 'LastName': 'Du', 'Affiliation': 'Beijing Tongren Eye Center, Beijing Tongren Hospital, Beijing Ophthalmology and Visual Science Key Lab, Beijing Institute of Ophthalmology, Capital Medical University, Beijing, China.'}, {'ForeName': 'Xintong', 'Initials': 'X', 'LastName': 'Liang', 'Affiliation': 'Beijing Tongren Eye Center, Beijing Tongren Hospital, Beijing Ophthalmology and Visual Science Key Lab, Beijing Institute of Ophthalmology, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yunyun', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Beijing Tongren Eye Center, Beijing Tongren Hospital, Beijing Ophthalmology and Visual Science Key Lab, Beijing Institute of Ophthalmology, Capital Medical University, Beijing, China.'}, {'ForeName': 'Duoxing', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Jiaxin', 'Initials': 'J', 'LastName': 'Tian', 'Affiliation': 'Beijing Tongren Eye Center, Beijing Tongren Hospital, Beijing Ophthalmology and Visual Science Key Lab, Beijing Institute of Ophthalmology, Capital Medical University, Beijing, China.'}, {'ForeName': 'Ningli', 'Initials': 'N', 'LastName': 'Wang', 'Affiliation': 'Beijing Tongren Eye Center, Beijing Tongren Hospital, Beijing Ophthalmology and Visual Science Key Lab, Beijing Institute of Ophthalmology, Capital Medical University, Beijing, China.'}]",JAMA ophthalmology,['10.1001/jamaophthalmol.2020.3820']
3039,32999269,Gestational diabetes mellitus prediction? A unique fatty acid profile study.,"OBJECTIVE


To elucidate whether women at risk of gestational diabetes mellitus (GDM) have a unique fatty acid profile compared to women considered normal healthy controls (NHC).
METHODS


Three hundred pregnant women were randomized to a control group (NHC) (n = 50) and to one of three high risk groups (n = 250), one of which was GDM (n = 50). At recruitment participants' booking bloods were taken and analyzed for lipid profiles. The GDM group's fatty acid profile is reported here.
RESULTS


GDM women compared to NHC had elevated levels of omega 6 (n-6) fatty acids compared to omega 3 (n-3) fatty acids (p = 0.01), of linoleic acid (LA) to docosahexaenoic acid (DHA) p = 0.001, sequentially distorted levels of n-6 fatty acids LA and arachidonic acid (ArA) p = 0.035, as well as significantly depressed levels of n-3 DHA (p = 0.01).
CONCLUSION


This paper shows that GDM women have a unique fatty acid profile with elevated levels of n-6 fats, depressed levels of n-3 fats and an abnormal pattern of sequential n-6 metabolism. This profile probably results from a combination of factors including underexpression and or poor utilization of desaturase enzymes, suboptimal dietary fatty acids intake, poor micronutrient status or dysbiosis of the microbiome. These results help inform development of a clinical predictive tool.",2020,"= 0.001, sequentially distorted levels of n-6 fatty acids LA and arachidonic acid (ArA)","['women considered normal healthy controls (NHC', 'Three hundred pregnant women', 'women at risk of gestational diabetes mellitus (GDM']",['control group (NHC'],"['elevated levels of omega 6 (n-6) fatty acids', 'n-6 fatty acids LA and arachidonic acid (ArA', 'n-3 DHA']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205307', 'cui_str': 'Normal'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1719844', 'cui_str': 'Omega'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0133860', 'cui_str': 'Fatty Acids, Omega-6'}, {'cui': 'C0023749', 'cui_str': 'Linoleic acid'}, {'cui': 'C0003695', 'cui_str': 'Arachidonic acid'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}]",300.0,0.0374251,"= 0.001, sequentially distorted levels of n-6 fatty acids LA and arachidonic acid (ArA)","[{'ForeName': 'Enitan', 'Initials': 'E', 'LastName': 'Ogundipe', 'Affiliation': 'Neonatal Unit, Chelsea and Westminster Hospital & Faculty of Medicine, Imperial College London, 369 Fulham Road, SW10 9NH, London, UK. e.ogundipe@imperial.ac.uk.'}, {'ForeName': 'Saidee', 'Initials': 'S', 'LastName': 'Samuelson', 'Affiliation': 'Academic Department of Obstetrics and Gynecology, Imperial College London, Chelsea and Westminster Hospital Campus, 3rd Floor, 369 Fulham Road, SW10 9NH, London, UK.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Crawford', 'Affiliation': 'Academic Department of Obstetrics and Gynecology (Lipid Biochemistry), Imperial College London, Chelsea and Westminster Hospital Campus, 3rd Floor, 369 Fulham Road, SW10 9NH, London, UK.'}]",Nutrition & diabetes,['10.1038/s41387-020-00138-9']
3040,33011429,Training older adults with virtual reality use to improve collision-avoidance behavior when walking through an aperture.,"Many older adults perform collision-avoidance behavior either insufficiently (i.e., frequent collision) or inefficiently (i.e., exaggerated behavior to ensure collision-avoidance). The present study examined whether a training system using virtual reality (VR) simulation enhanced older adults' collision-avoidance behavior in response to a VR image of an aperture during real walking. Twenty-five (n = 13 intervention group and n = 12 control group) older individuals participated. During training, a VR image of walking through an aperture was projected onto a large screen. Participants in the intervention group tried to avoid virtual collision with the minimum body rotation required to walk on the spot through a variety of narrow apertures. Participants in the control group remained without body rotation while walking on the spot through a wide aperture. A comparison between pre-test and post-test performances in the real environment indicated that after the training, significantly smaller body rotation angles were observed in the intervention group. This suggests that the training led participants to modify their behavior to try to move efficiently during real walking. However, although not significant, collision rates also tended to be greater, suggesting that, at least for some participants, the modification required to avoid collision was too difficult. Transfer of the learned behavior using the VR environment to real walking is discussed.",2020,"A comparison between pre-test and post-test performances in the real environment indicated that after the training, significantly smaller body rotation angles were observed in the intervention group.","['Training older adults with virtual reality', 'n\u202f=\u202f12 control group) older individuals participated']","['avoid virtual collision with the minimum body rotation required to walk on the spot through a variety of narrow apertures', 'training system using virtual reality (VR) simulation']","['body rotation', 'collision rates', 'smaller body rotation angles']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0332463', 'cui_str': 'Narrowed structure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}]","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0205143', 'cui_str': 'Angular'}]",,0.0141464,"A comparison between pre-test and post-test performances in the real environment indicated that after the training, significantly smaller body rotation angles were observed in the intervention group.","[{'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Kondo', 'Affiliation': 'Department of Health Promotion Science, Tokyo Metropolitan University, Tokyo, Japan; Department of Physical Rehabilitation, National Center Hospital, National Center of Neurology and Psychiatry, Tokyo, Japan.'}, {'ForeName': 'Kazunobu', 'Initials': 'K', 'LastName': 'Fukuhara', 'Affiliation': 'Department of Health Promotion Science, Tokyo Metropolitan University, Tokyo, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Suda', 'Affiliation': 'Department of Health Promotion Science, Tokyo Metropolitan University, Tokyo, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Higuchi', 'Affiliation': 'Department of Health Promotion Science, Tokyo Metropolitan University, Tokyo, Japan. Electronic address: higuchit@tmu.ac.jp.'}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2020.104265']
3041,33011482,Combined utility of blood glucose and white blood cell in predicting outcome after acute ischemic stroke: The ENCHANTED trial.,"BACKGROUND


As hyperglycemia and leukocytosis individually predict poor outcome in acute ischemic stroke (AIS), we aimed to determine the significance of their combination on functional outcome and symptomatic intracerebral hemorrhage (sICH) among participants of the Enhanced Control of Hypertension and Thrombolysis Stroke Study (ENCHANTED).
METHODS


Post-hoc analyzes of the full ENCHANTED cohort, an international, multicenter, quasi-factorial, randomized, open, blinded outcome-assessed trial of low- versus standard-dose intravenous alteplase and early intensive versus standard blood pressure (BaP) lowering treatment in 4557 thrombolysis-eligible and treated AIS patients. Patients were divided into four groups according to baseline blood glucose and white blood cells (WBC) levels: A (normal glucose + WBC), B (hyperglycemia + normal WBC), C (normal glucose + high WBC), and D (hyperglycemia + high WBC). Logistic regression models were used to determine associations of each group and poor functional outcome (modified Rankin scale scores 2-6) at 90 days and sICH within 48 h, adjusted for confounders. Quality of model fit was examined with Akaike information classification (AIC), Bayesian information classification (BIC), and likelihood ratio test.
RESULTS


Of 4181 AIS patients included in analyzes, and with group A as the reference, an increasing odds of poor functional outcome was evident across groups B (odds ratio [OR] 1.38, 95 % confidence interval [CI] 1.17-1.63), C (OR 1.26, 95 %CI 0.99-1.60), and D (OR 2.26, 95 %CI 1.79-2.85) (P trend <0.001). Group D patients also had a higher rate of sICH (P trend <0.05). The model fit with the combination of blood glucose and WBC was better than models of their individual components.
CONCLUSIONS


Using a combination of blood glucose and WBC provides strong prognostic significance than either alone in thrombolyzed AIS patients.",2020,Group D patients also had a higher rate of sICH (P trend <0.05).,"['4557 thrombolysis-eligible and treated AIS patients', 'participants of the Enhanced Control of Hypertension and Thrombolysis Stroke Study (ENCHANTED', 'acute ischemic stroke', '4181 AIS patients', 'acute ischemic stroke (AIS', 'thrombolyzed AIS patients']","['low- versus standard-dose intravenous alteplase and early intensive versus standard blood pressure (BaP) lowering treatment', 'blood glucose and white blood cell']","['rate of sICH', 'baseline blood glucose and white blood cells (WBC) levels: A (normal glucose\u2009+\u2009WBC), B (hyperglycemia\u2009+\u2009normal WBC), C (normal glucose\u2009+\u2009high WBC), and D (hyperglycemia\u2009+\u2009high WBC', 'blood glucose and WBC', 'Akaike information classification (AIC), Bayesian information classification (BIC), and likelihood ratio test']","[{'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}]","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0860800', 'cui_str': 'Glucose normal'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",,0.0885454,Group D patients also had a higher rate of sICH (P trend <0.05).,"[{'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Xia', 'Affiliation': 'Department of Neurosurgery, West China Hospital, Sichuan University, Chengdu, Sichuan, PR China; The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Richard I', 'Initials': 'RI', 'LastName': 'Lindley', 'Affiliation': 'Westmead Applied Research Centre, University of Sydney, Sydney, NSW, Australia; The George Institute for Global Health, Sydney, NSW, Australia.'}, {'ForeName': 'Candice', 'Initials': 'C', 'LastName': 'Delcourt', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia; Sydney Medical School, University of Sydney, Sydney, NSW, Australia; Department of Neurology, Royal Prince Alfred Hospital, Sydney Health Partners, Sydney, NSW, Australia.'}, {'ForeName': 'Zien', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia; Department of Radiology, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, PR China.'}, {'ForeName': 'Xiaoying', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia; Sydney Medical School, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Carcel', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia; Sydney Medical School, University of Sydney, Sydney, NSW, Australia; Department of Neurology, Royal Prince Alfred Hospital, Sydney Health Partners, Sydney, NSW, Australia.'}, {'ForeName': 'Alejandra', 'Initials': 'A', 'LastName': 'Malavera', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Zeljka', 'Initials': 'Z', 'LastName': 'Calic', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Craig S', 'Initials': 'CS', 'LastName': 'Anderson', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia; Department of Neurology, Royal Prince Alfred Hospital, Sydney Health Partners, Sydney, NSW, Australia; The George Institute China at Peking University Health Science Centre, Beijing, PR China; Heart Health Research Center, Beijing, PR China. Electronic address: canderson@georgeinstitute.org.au.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2020.106254']
3042,33011502,"Intrauterine fundal anaesthesia during endometrial ablation in the office: A randomised double-blind, non-inferiority trial.","OBJECTIVE


To evaluate the effect of intrauterine fundal anaesthesia during outpatient endometrial ablation.
STUDY DESIGN


A randomised, double-blinded non-inferiority trial was performed in one hospital and one independent treatment center in the Netherlands. A total of 96 women who were planned for a NovaSure® endometrial ablation under local anaesthesia between December 2015 and February 2018 were included in this trial. These women were randomised to paracervical anaesthesia combined with hysteroscopic fundal infiltration with anaesthestics or paracervical anaesthesia combined with hysteroscopic fundal infiltration with saline. The primary outcome was pain during ablation. To study non-inferiority of paracervical anaesthesia without fundal anaesthesia, we assessed the co-primary endpoints Faces Pain Score and Numeric Rating Score. Secondary outcomes included pain scores at other moments during and after the procedure, postoperative use of analgesics, satisfaction, side-effects and complications. The primary outcomes were tested with a non-inferiority margin (2.0 points on changes in pain), and the secondary outcomes were compared using conventional statistical methods.
RESULTS


Paracervical anaesthesia without fundal anaesthesia did not establish non-inferiority to the combination of paracervical anaesthesia and fundal infiltration with anaesthetics when both primary outcome variables of pain were taken into account (Numeric Rating Scale 5.0 versus 3.9 (mean difference 1.2 (95% CI 0.1-2.2)) and Faces Pain Score 5.4 versus 4.8 (mean difference 0.6 (95% CI -0.3-1.5))). Secondary pain scores measured during the procedure were higher or similar in women receiving fundal infiltration with saline as compared to women who received fundal infiltration with anaesthetics. After the procedure, there were no differences in reported pain scores, satisfaction, and side-effects. In the group who received fundal infiltration with saline, more women were admitted to the hospital because of severe pain (3 versus 0 women) and endometritis (1 versus 0 women).
CONCLUSION


This study did not confirm non-inferiority of paracervical anaesthesia without fundal anaesthesia to the combination of paracervical anaesthesia with fundal anaesthesia in the reduction of pain during endometrial ablation and therefore provides no reason to leave out fundal anaesthesia. We recommend to use fundal anaesthesia combined with paracervical anaesthesia to reduce pain during endometrial ablation in the office.",2020,Secondary pain scores measured during the procedure were higher or similar in women receiving fundal infiltration with saline as compared to women who received fundal infiltration with anaesthetics.,"['Intrauterine fundal anaesthesia during endometrial ablation in the office', 'women were admitted to the hospital because of severe pain (3 versus 0 women) and endometritis (1 versus 0 women', '96 women who were planned for a NovaSure® endometrial ablation under local anaesthesia between December 2015 and February 2018 were included in this trial', 'one hospital and one independent treatment center in the Netherlands']","['paracervical anaesthesia with fundal anaesthesia', 'fundal infiltration with saline', 'paracervical anaesthesia combined with hysteroscopic fundal infiltration with anaesthestics or paracervical anaesthesia combined with hysteroscopic fundal infiltration with saline', 'paracervical anaesthesia without fundal anaesthesia', 'intrauterine fundal anaesthesia', 'fundal anaesthesia combined with paracervical anaesthesia']","['Secondary pain scores', 'co-primary endpoints Faces Pain Score and Numeric Rating Score', 'pain scores at other moments during and after the procedure, postoperative use of analgesics, satisfaction, side-effects and complications', 'pain scores, satisfaction, and side-effects', 'non-inferiority margin (2.0 points on changes in pain', 'pain during ablation', 'Faces Pain Score', 'pain']","[{'cui': 'C0694756', 'cui_str': 'Intrauterine'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0341803', 'cui_str': 'Endometrial ablation'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0278140', 'cui_str': 'Severe pain'}, {'cui': 'C0014179', 'cui_str': 'Endometritis'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C1720162', 'cui_str': 'Under local anesthesia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}]","[{'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0694756', 'cui_str': 'Intrauterine'}]","[{'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0015468', 'cui_str': 'Pain in face'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0237666', 'cui_str': 'Inferiority feeling'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}]",96.0,0.583245,Secondary pain scores measured during the procedure were higher or similar in women receiving fundal infiltration with saline as compared to women who received fundal infiltration with anaesthetics.,"[{'ForeName': 'I M A', 'Initials': 'IMA', 'LastName': 'Reinders', 'Affiliation': 'Department of Obstetrics and Gynaecology, Máxima MC, Veldhoven, the Netherlands; Department of Obstetrics and Gynaecology, GROW - School for Oncology and Developmental Biology, Maastricht University Medical Centre, the Netherlands. Electronic address: imke.reinders@maastrichtuniversity.nl.'}, {'ForeName': 'P M A J', 'Initials': 'PMAJ', 'LastName': 'Geomini', 'Affiliation': 'Department of Obstetrics and Gynaecology, Máxima MC, Veldhoven, the Netherlands. Electronic address: P.Geomini@mmc.nl.'}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Leemans', 'Affiliation': 'Department of Obstetrics and Gynaecology, Máxima MC, Veldhoven, the Netherlands. Electronic address: Jaklien.Leemans@mmc.nl.'}, {'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Dieleman', 'Affiliation': 'Science Office, Academy, Máxima MC, Veldhoven, the Netherlands. Electronic address: J.Dieleman@mmc.nl.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Timmermans', 'Affiliation': 'Department of Obstetrics and Gynaecology, Academic Medical Center, Amsterdam, the Netherlands; Bergman Clinics Vrouw, Amsterdam, AMC, the Netherlands. Electronic address: a.timmermans@amsterdamumc.nl.'}, {'ForeName': 'M E', 'Initials': 'ME', 'LastName': 'de Lange', 'Affiliation': 'Department of Obstetrics and Gynaecology, Academic Medical Center, Amsterdam, the Netherlands; Bergman Clinics Vrouw, Amsterdam, AMC, the Netherlands. Electronic address: m.e.delange@amsterdamumc.nl.'}, {'ForeName': 'M Y', 'Initials': 'MY', 'LastName': 'Bongers', 'Affiliation': 'Department of Obstetrics and Gynaecology, Máxima MC, Veldhoven, the Netherlands; Department of Obstetrics and Gynaecology, GROW - School for Oncology and Developmental Biology, Maastricht University Medical Centre, the Netherlands. Electronic address: M.Bongers@mmc.nl.'}]","European journal of obstetrics, gynecology, and reproductive biology",['10.1016/j.ejogrb.2020.09.011']
3043,33011539,Genital Self-Image in Adolescent Girls: The Effectiveness of a Brief Educational Video.,"The study investigated the effectiveness of a very brief video aimed at increasing adolescent girls' knowledge of the variation in normal female genital appearance and improving their attitudes towards their own genitals. The video was developed by the researchers and included information about the anatomical features of cisgender female genitals and their function, as well as emphasizing the diversity in the appearance of these features, particularly the external genitalia or vulvar region. A sample of 343 female adolescents aged 16-18 years were randomly assigned to view the educational video or a control video. The educational video significantly increased the girls' knowledge of female genital anatomy. The educational video also significantly increased genital appearance satisfaction and decreased consideration of undergoing cosmetic genital surgery or labiaplasty in the future. The participants who watched the educational video were also more likely to recommend focusing on the diversity in normal female genital appearance when educating other young people on the topic of female genital anatomy. Our results suggest that a very brief educational video could be a useful tool to assist young girls with their genital self-image.",2020,The educational video also significantly increased genital appearance satisfaction and decreased consideration of undergoing cosmetic genital surgery or labiaplasty in the future.,"['adolescent girls', '343 female adolescents aged 16-18 years', 'Adolescent Girls']","['educational video or a control video', 'Brief Educational Video']","['genital appearance satisfaction', 'Genital Self-Image', ""girls' knowledge of female genital anatomy""]","[{'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}]","[{'cui': 'C0017420', 'cui_str': 'Reproductive System'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0242498', 'cui_str': 'Self-image'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0017421', 'cui_str': 'Female genital'}, {'cui': 'C0002808', 'cui_str': 'Anatomy'}]",343.0,0.014125,The educational video also significantly increased genital appearance satisfaction and decreased consideration of undergoing cosmetic genital surgery or labiaplasty in the future.,"[{'ForeName': 'Anne Nileshni', 'Initials': 'AN', 'LastName': 'Fernando', 'Affiliation': 'Monash Alfred Psychiatry Research Centre, Monash University, Melbourne, Victoria, 3004, Australia. Electronic address: anfer4@student.monash.edu.'}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Sharp', 'Affiliation': 'Monash Alfred Psychiatry Research Centre, Monash University, Melbourne, Victoria, 3004, Australia. Electronic address: gemma.sharp@monash.edu.'}]",Body image,['10.1016/j.bodyim.2020.08.007']
3044,33012605,First-in-human randomised trial and follow-up study of Plasmodium falciparum blood-stage malaria vaccine BK-SE36 with CpG-ODN(K3).,"BACKGROUND


BK-SE36 is blood-stage malaria vaccine candidate that is undergoing clinical trials. Here, the safety and immunogenicity of BK-SE36 with a novel adjuvant, CpG-ODN(K3) (thus, BK-SE36/CpG) was assessed in a phase 1a trial in Japan.
METHODS


An investigator-initiated, randomised, single-blind, placebo-controlled, dose-escalation study was conducted at Osaka University Hospital with 26 healthy malaria naïve Japanese male adults. The trial was conducted in two stages: Stage/Group 1, half-dose (n = 7 for BK-SE36/CpG and n = 3 for control) and Stage/Group 2, full-dose (n = 11 for BK-SE36/CpG and n = 5 for control). There were two intramuscular vaccinations 21 days apart for both half-dose (0.5 ml: 50 µg SE36 + 500 µg aluminum + 500 µg K3) and full-dose (1.0 ml: 100 µg SE36 + 1000 µg aluminum + 1000 µg K3). A one-year follow-up was done to monitor changes in autoimmune markers and vaccine-induced antibody response.
RESULTS


BK-SE36/CpG was well tolerated. Vaccination site reactions were similar to those observed with BK-SE36. During the trial and follow-up period, no subject had clinical evidence of autoimmune disease. The full-dose group had significantly higher titres than the half-dose group (Student's t-test, p = 0.002) at 21 days post-second vaccination. Antibody titres remained above baseline values during 12 months of follow-up. The vaccine induced antibody was mostly composed of IgG1 and IgM, and recognised epitopes close to the polyserine region located in the middle of SE36.
CONCLUSIONS


BK-SE36/CpG has an acceptable safety profile. Use of CpG-ODN(K3) greatly enhanced immunogenicity in malaria naïve Japanese adults when compared to BK-SE36 alone. The utility of BK-SE36/CpG is currently under evaluation in a malaria endemic setting in West Africa.
TRIAL REGISTRATION


JMACCT Clinical Trial Registry JMA-IIA00109.",2020,"The full-dose group had significantly higher titres than the half-dose group (Student's t-test, p = 0.002) at 21 days post-second vaccination.","['26 healthy malaria naïve Japanese male adults', 'malaria naïve Japanese adults', 'malaria endemic setting in West Africa']","['BK-SE36/CpG', 'CpG-ODN(K3', 'SE36\xa0+\xa0500\xa0µg aluminum\xa0+\xa0500\xa0µg\xa0K3) and full-dose', 'Plasmodium falciparum blood-stage malaria vaccine BK-SE36 with CpG-ODN(K3', 'placebo', 'SE36\xa0+\xa01000\xa0µg aluminum\xa0+\xa01000\xa0µg\xa0K3']","['immunogenicity', 'Antibody titres', 'tolerated', 'Vaccination site reactions']","[{'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0243130', 'cui_str': 'endemics'}, {'cui': 'C0001747', 'cui_str': 'Western Africa'}]","[{'cui': 'C0056912', 'cui_str': ""cytidylyl-3'-5'-guanosine""}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0002367', 'cui_str': 'Aluminum'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0032150', 'cui_str': 'Plasmodium falciparum'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0206255', 'cui_str': 'Malarial Vaccines'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1883310', 'cui_str': '1000'}]","[{'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C1142480', 'cui_str': 'Vaccination site reaction'}]",,0.109799,"The full-dose group had significantly higher titres than the half-dose group (Student's t-test, p = 0.002) at 21 days post-second vaccination.","[{'ForeName': 'Sachiko', 'Initials': 'S', 'LastName': 'Ezoe', 'Affiliation': 'Medical Center for Translational Research, Department of Medical Innovation, Osaka University Hospital, 2-2 Yamadaoka, Suita, Osaka 565-0871, Japan; Department of Environmental Space Infection Control, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka 565-0871, Japan.'}, {'ForeName': 'Nirianne Marie Q', 'Initials': 'NMQ', 'LastName': 'Palacpac', 'Affiliation': 'Department of Molecular Protozoology, Research Institute for Microbial Diseases, Osaka University, 3-1 Yamadaoka, Suita, Osaka 565-0871, Japan.'}, {'ForeName': 'Kohhei', 'Initials': 'K', 'LastName': 'Tetsutani', 'Affiliation': 'Laboratory of Adjuvant Innovation/Mockup Vaccine, Center for Vaccine Adjuvant Research, National Institute of Biomedical Innovation, Health and Nutrition, 7-6-8, Saito-Asagi, Ibaraki City, Osaka 567-0085, Japan; Laboratory of Vaccine Science, Immunology Frontier Research Center (IFReC), Osaka University, 3-1 Yamadaoka, Suita, Osaka 565-0871, Japan.'}, {'ForeName': 'Kouji', 'Initials': 'K', 'LastName': 'Yamamoto', 'Affiliation': 'Data Coordinating Center, Department of Medical Innovation, Osaka University Hospital, 2-2 Yamadaoka, Suita, Osaka 565-0871, Japan.'}, {'ForeName': 'Kiyoshi', 'Initials': 'K', 'LastName': 'Okada', 'Affiliation': 'Department of Orthopaedics, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka 565-0871, Japan.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Taira', 'Affiliation': 'Medical Center for Translational Research, Department of Medical Innovation, Osaka University Hospital, 2-2 Yamadaoka, Suita, Osaka 565-0871, Japan; Department of Cardiovascular Surgery, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka 565-0871, Japan.'}, {'ForeName': 'Sumiyuki', 'Initials': 'S', 'LastName': 'Nishida', 'Affiliation': 'Department of Respiratory Medicine and Clinical Immunology, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka 565-0871, Japan.'}, {'ForeName': 'Haruhiko', 'Initials': 'H', 'LastName': 'Hirata', 'Affiliation': 'Department of Respiratory Medicine and Clinical Immunology, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka 565-0871, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Ogata', 'Affiliation': 'Department of Respiratory Medicine and Clinical Immunology, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka 565-0871, Japan.'}, {'ForeName': 'Tomomi', 'Initials': 'T', 'LastName': 'Yamada', 'Affiliation': 'Data Coordinating Center, Department of Medical Innovation, Osaka University Hospital, 2-2 Yamadaoka, Suita, Osaka 565-0871, Japan.'}, {'ForeName': 'Masanori', 'Initials': 'M', 'LastName': 'Yagi', 'Affiliation': 'Department of Molecular Protozoology, Research Institute for Microbial Diseases, Osaka University, 3-1 Yamadaoka, Suita, Osaka 565-0871, Japan.'}, {'ForeName': 'Jyotheeswara R', 'Initials': 'JR', 'LastName': 'Edula', 'Affiliation': 'Department of Molecular Protozoology, Research Institute for Microbial Diseases, Osaka University, 3-1 Yamadaoka, Suita, Osaka 565-0871, Japan.'}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Oishi', 'Affiliation': 'Department of Molecular Protozoology, Research Institute for Microbial Diseases, Osaka University, 3-1 Yamadaoka, Suita, Osaka 565-0871, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Tougan', 'Affiliation': 'Department of Molecular Protozoology, Research Institute for Microbial Diseases, Osaka University, 3-1 Yamadaoka, Suita, Osaka 565-0871, Japan.'}, {'ForeName': 'Ken J', 'Initials': 'KJ', 'LastName': 'Ishii', 'Affiliation': 'Laboratory of Adjuvant Innovation/Mockup Vaccine, Center for Vaccine Adjuvant Research, National Institute of Biomedical Innovation, Health and Nutrition, 7-6-8, Saito-Asagi, Ibaraki City, Osaka 567-0085, Japan; Laboratory of Vaccine Science, Immunology Frontier Research Center (IFReC), Osaka University, 3-1 Yamadaoka, Suita, Osaka 565-0871, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Myoui', 'Affiliation': 'Medical Center for Translational Research, Department of Medical Innovation, Osaka University Hospital, 2-2 Yamadaoka, Suita, Osaka 565-0871, Japan. Electronic address: myoi@hp-mctr.med.osaka-u.ac.jp.'}, {'ForeName': 'Toshihiro', 'Initials': 'T', 'LastName': 'Horii', 'Affiliation': 'Department of Molecular Protozoology, Research Institute for Microbial Diseases, Osaka University, 3-1 Yamadaoka, Suita, Osaka 565-0871, Japan. Electronic address: horii@biken.osaka-u.ac.jp.'}]",Vaccine,['10.1016/j.vaccine.2020.09.056']
3045,32995820,Hydroxychloroquine as pre-exposure prophylaxis for COVID-19 in healthcare workers: a randomized trial.,"BACKGROUND


Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a rapidly emerging virus causing the ongoing Covid-19 pandemic with no known effective prophylaxis. We investigated whether hydroxychloroquine could prevent SARS CoV-2 in healthcare workers at high-risk of exposure.
METHODS


We conducted a randomized, double-blind, placebo-controlled clinical trial of healthcare workers with ongoing exposure to persons with Covid-19, including those working in emergency departments, intensive care units, Covid-19 hospital wards, and first responders. Participants across the United States and in the Canadian province of Manitoba were randomized to hydroxychloroquine 400mg once weekly or twice weekly for 12 weeks. The primary endpoint was confirmed or probable Covid-19-compatible illness. We measured hydroxychloroquine whole blood concentrations.
RESULTS


We enrolled 1483 healthcare workers, of which 79% reported performing aerosol-generating procedures. The incidence of Covid-19 (laboratory-confirmed or symptomatic compatible illness) was 0.27 events per person-year with once-weekly and 0.28 events per person-year with twice-weekly hydroxychloroquine compared with 0.38 events per person-year with placebo. For once weekly hydroxychloroquine prophylaxis, the hazard ratio was 0.72 (95%CI 0.44 to 1.16; P=0.18) and for twice weekly was 0.74 (95%CI 0.46 to 1.19; P=0.22) as compared with placebo. Median hydroxychloroquine concentrations in whole blood were 98 ng/mL (IQR, 82-120) with once-weekly and 200 ng/mL (IQR, 159-258) with twice-weekly dosing. Hydroxychloroquine concentrations did not differ between participants who developed Covid-19 (154 ng/mL) versus participants without Covid-19 (133 ng/mL; P=0.08).
CONCLUSIONS


Pre-exposure prophylaxis with hydroxychloroquine once or twice weekly did not significantly reduce laboratory-confirmed Covid-19 or Covid-19-compatible illness among healthcare workers.",2020,"Hydroxychloroquine concentrations did not differ between participants who developed Covid-19 (154 ng/mL) versus participants without Covid-19 (133 ng/mL; P=0.08).
","['healthcare workers at high-risk of exposure', 'healthcare workers', 'Participants across the United States and in the Canadian province of Manitoba', 'healthcare workers with ongoing exposure to persons with Covid-19, including those working in emergency departments, intensive care units, Covid-19 hospital wards, and first responders', 'We enrolled 1483 healthcare workers, of which 79% reported performing aerosol-generating procedures']","['placebo', 'hydroxychloroquine', 'Hydroxychloroquine']","['Hydroxychloroquine concentrations', 'Median hydroxychloroquine concentrations', 'probable Covid-19-compatible illness', 'incidence of Covid-19 (laboratory-confirmed or symptomatic compatible illness']","[{'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0024726', 'cui_str': 'Manitoba'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0557351', 'cui_str': 'Employed'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C3178988', 'cui_str': 'Emergency First Responders'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0001712', 'cui_str': 'Aerosol'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0332290', 'cui_str': 'Consistent with'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}]",1483.0,0.742346,"Hydroxychloroquine concentrations did not differ between participants who developed Covid-19 (154 ng/mL) versus participants without Covid-19 (133 ng/mL; P=0.08).
","[{'ForeName': 'Radha', 'Initials': 'R', 'LastName': 'Rajasingham', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Ananta S', 'Initials': 'AS', 'LastName': 'Bangdiwala', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Melanie R', 'Initials': 'MR', 'LastName': 'Nicol', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Caleb P', 'Initials': 'CP', 'LastName': 'Skipper', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Katelyn A', 'Initials': 'KA', 'LastName': 'Pastick', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Margaret L', 'Initials': 'ML', 'LastName': 'Axelrod', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Matthew F', 'Initials': 'MF', 'LastName': 'Pullen', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Alanna A', 'Initials': 'AA', 'LastName': 'Nascene', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Darlisha A', 'Initials': 'DA', 'LastName': 'Williams', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Nicole W', 'Initials': 'NW', 'LastName': 'Engen', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Okafor', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Brian I', 'Initials': 'BI', 'LastName': 'Rini', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Ingrid A', 'Initials': 'IA', 'LastName': 'Mayer', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Emily G', 'Initials': 'EG', 'LastName': 'McDonald', 'Affiliation': 'Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal.'}, {'ForeName': 'Todd C', 'Initials': 'TC', 'LastName': 'Lee', 'Affiliation': 'Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': 'Oregon Health & Science University, Portland, OR.'}, {'ForeName': 'Lauren J', 'Initials': 'LJ', 'LastName': 'MacKenzie', 'Affiliation': 'Section of Infectious Diseases, Department of Internal Medicine, University of Manitoba, Winnipeg, Manitoba.'}, {'ForeName': 'Justin M', 'Initials': 'JM', 'LastName': 'Balko', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Dunlop', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Katherine H', 'Initials': 'KH', 'LastName': 'Hullsiek', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Boulware', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Sarah M', 'Initials': 'SM', 'LastName': 'Lofgren', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota.'}]",medRxiv : the preprint server for health sciences,['10.1101/2020.09.18.20197327']
3046,32994227,Bridging Western and Indigenous knowledge through intercultural dialogue: lessons from participatory research in Mexico.,"Indigenous communities in Latin America and elsewhere have complex bodies of knowledge, but Western health services generally approach them as vulnerable people in need of external solutions. Intercultural dialogue recognises the validity and value of Indigenous standpoints, and participatory research promotes reciprocal respect for stakeholder input in knowledge creation.As part of their decades-long community-based work in Mexico's Guerrero State, researchers at the  Centro de Investigación de Enfermedades Tropicales  responded to the request from Indigenous communities to help them address poor maternal health. We present the experience from this participatory research in which both parties contributed to finding solutions for a shared concern. The aim was to open an intercultural dialogue by respecting Indigenous skills and customs, recognising the needs of health service stakeholders for scientific evidence.Three steps summarise the opening of intercultural dialogue.  Trust building and partnership  based on mutual respect and principles of cultural safety. This focused on understanding traditional midwifery and the cultural conflicts in healthcare for Indigenous women. A pilot randomised controlled trial was an opportunity to  listen and to adjust the lexicon  identifying and testing culturally coherent responses for maternal health led by traditional midwives.  Codesign, evaluation and discussion  happened during a full cluster randomised trial to identify benefits of supporting traditional midwifery on maternal outcomes. A narrative mid-term evaluation and cognitive mapping of traditional knowledge offered additional evidence to discuss with other stakeholders the benefits of intercultural dialogue. These steps are not mechanistic or invariable. Other contexts might require additional steps. In Guerrero, intercultural dialogue included recovering traditional midwifery and producing high-level epidemiological evidence of the value of traditional midwives, allowing service providers to draw on the strengths of different cultures.",2020,"Intercultural dialogue recognises the validity and value of Indigenous standpoints, and participatory research promotes reciprocal respect for stakeholder input in knowledge creation.","['maternal health led by traditional midwives', 'healthcare for Indigenous women']",[],[],"[{'cui': 'C0024921', 'cui_str': 'Maternal Health'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0026083', 'cui_str': 'Professional midwife'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]",[],[],,0.0304384,"Intercultural dialogue recognises the validity and value of Indigenous standpoints, and participatory research promotes reciprocal respect for stakeholder input in knowledge creation.","[{'ForeName': 'Iván', 'Initials': 'I', 'LastName': 'Sarmiento', 'Affiliation': 'CIET-PRAM, Department of Family Medicine, McGill University, Montreal, Quebec, Canada ivan.sarmiento@mail.mcgill.ca.'}, {'ForeName': 'Germán', 'Initials': 'G', 'LastName': 'Zuluaga', 'Affiliation': 'Grupo de Estudios en Sistemas Tradicionales de Salud (GESTS), Universidad del Rosario, Bogotá, Cundinamarca, Colombia.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Paredes-Solís', 'Affiliation': 'Centro de Investigación de Enfermedades Tropicales (CIET), Universidad Autónoma de Guerrero, Acapulco, Guerrero, México.'}, {'ForeName': 'Anne Marie', 'Initials': 'AM', 'LastName': 'Chomat', 'Affiliation': 'CIET-PRAM, Department of Family Medicine, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Loutfi', 'Affiliation': 'CIET-PRAM, Department of Family Medicine, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Cockcroft', 'Affiliation': 'CIET-PRAM, Department of Family Medicine, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Andersson', 'Affiliation': 'CIET-PRAM, Department of Family Medicine, McGill University, Montreal, Quebec, Canada.'}]",BMJ global health,['10.1136/bmjgh-2020-002488']
3047,32994235,Evaluating an implementation programme for medication review with follow-up in community pharmacy using a hybrid effectiveness study design: translating evidence into practice.,"OBJECTIVES


To evaluate an implementation programme of a community pharmacy medication review with follow-up (MRF) service using a hybrid effectiveness-implementation study design, and to compare the clinical and humanistic outcomes with those in a previously conducted cluster randomised controlled trial (cRCT).
SETTING


Community pharmacies in Spain.
PARTICIPANTS


135 community pharmacies and 222 pharmacists providing MRF to polymedicated patients aged 65 or over.
INTERVENTION


The intervention was an implementation programme for the MRF service. A national level group was established, mirrored with a provincial level group. A series of interventions were defined (1) to engage pharmacy owners with the implementation model and (2) to provide training to pharmacists consisting of clinical case studies, process of MRF, communication skills and data collection methods and (3) practice change facilitators.
PRIMARY AND SECONDARY OUTCOME MEASURES


The primary outcomes for the implementation programme were progress, reach, fidelity and integration. The secondary outcomes were number of medications, non-controlled health problems, emergency visits, hospitalisations and health-related quality of life, which were compared with a previous 6-month cluster RCT.
RESULTS


55% of pharmacies reached the implementation phase and 35.6% remained in the testing phase at 12 months. A reach of 89.3% (n=844) was achieved. Fidelity average score was 8.45 (min: 6.2, max: 9.3) out of 10. The integration mean score was 3.39 (SD: 0.72) out of 5. MRF service outcomes were similar to the cluster RCT study; however, the magnitude of the outcomes was delayed.
CONCLUSIONS


The implementation of pharmacy services is a complex multifactorial process, conditioned by numerous implementation factors. In the absence of remuneration, the implementation of the MRF service is a slow process, taking at least 12 months to complete.
TRIAL REGISTRATION NUMBER


CGFTRA-2017-01.",2020,"Fidelity average score was 8.45 (min: 6.2, max: 9.3) out of 10.","['135 community pharmacies and 222 pharmacists providing MRF to polymedicated patients aged 65 or over', 'Community pharmacies in Spain']",[],"['number of medications, non-controlled health problems, emergency visits, hospitalisations and health-related quality of life', 'MRF service outcomes', 'progress, reach, fidelity and integration', 'integration mean score', 'Fidelity average score']","[{'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0009478', 'cui_str': 'Community Pharmacies'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0560023', 'cui_str': 'Review of medication'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0037747', 'cui_str': 'Spain'}]",[],"[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0560023', 'cui_str': 'Review of medication'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0949128,"Fidelity average score was 8.45 (min: 6.2, max: 9.3) out of 10.","[{'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Varas-Doval', 'Affiliation': 'Department of Pharmaceutical Services, Spanish General Council of Official Colleges of Pharmacists, Madrid, Spain.'}, {'ForeName': 'Miguel A', 'Initials': 'MA', 'LastName': 'Gastelurrutia', 'Affiliation': 'Pharmaceutical Care Research Group, CTS-131, University of Granada Faculty of Pharmacy, Granada, Spain magastelu@farmanorte.org.'}, {'ForeName': 'Shalom I', 'Initials': 'SI', 'LastName': 'Benrimoj', 'Affiliation': 'Pharmaceutical Care Research Group, CTS-131, University of Granada Faculty of Pharmacy, Granada, Spain.'}, {'ForeName': 'Maria Jose', 'Initials': 'MJ', 'LastName': 'Zarzuelo', 'Affiliation': 'Pharmaceutical Care Research Group, CTS-131, University of Granada Faculty of Pharmacy, Granada, Spain.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Garcia-Cardenas', 'Affiliation': 'Graduate School of Health, University of Technology Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Perez-Escamilla', 'Affiliation': 'Pharmaceutical Care Research Group, CTS-131, University of Granada Faculty of Pharmacy, Granada, Spain.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Martínez-Martínez', 'Affiliation': 'Clinical Pharmacy Section, Pharmacy Department, Universidad de Granada, Granada, Spain.'}]",BMJ open,['10.1136/bmjopen-2019-036669']
3048,32994236,Clinically SUspected ScaPhoid fracturE: treatment with supportive bandage or CasT? 'Study protocol of a multicenter randomized controlled trial' (SUSPECT study).,"INTRODUCTION


Some scaphoid fractures become visible on radiographs weeks after a trauma which makes normal radiographs directly after trauma unreliable. Untreated scaphoid fractures can lead to scaphoid non-union progressing to osteoarthritis. Therefore, the general treatment for patients with a clinically suspected scaphoid fracture and normal initial radiographs is immobilisation with below-elbow cast for 2 weeks. However, most of these patients are treated unnecessarily because eventually less than 10% of them are diagnosed with an occult scaphoid fracture. To reduce overtreatment and costs as a result of unnecessary cast treatment in patients with a clinically suspected scaphoid fracture and normal initial radiographs, we designed a study to compare below-elbow cast treatment with supportive bandage treatment. We hypothesise that the functional outcome after 3 months is not inferior in patients treated with supportive bandage compared to patients treated with below-elbow cast, but with lower costs in the supportive bandage group.
METHODS AND ANALYSIS


The SUSPECT study is an open-labelled multicentre randomised controlled trial with non-inferiority design. A total of 180 adult patients with a clinically suspected scaphoid fracture and normal initial radiographs are randomised between two groups: 3 days of supportive bandage or 2 weeks of below-elbow cast. We aim to evaluate the functional outcome and cost-effectiveness of both treatments. The primary outcome is the functional outcome after 3 months, assessed with the Quick Disability of the Arm, Shoulder and Hand score. Secondary outcomes include functional outcome, recovery of function, pain, patient satisfaction, quality of life and cost-effectiveness measured by medical consumption, absence from work or decreased productivity.
ETHICS AND DISSEMINATION


The Medical Ethics Committee of the Erasmus MC Medical Centre, Rotterdam, approved the study protocol (MEC-2017-504). We plan to present the results after completion of the study at (inter)national conferences and publish in general peer-reviewed journals.
TRIAL REGISTRATION NUMBER


NL6976.",2020,"The primary outcome is the functional outcome after 3 months, assessed with the Quick Disability of the Arm, Shoulder and Hand score.","['patients with a clinically suspected scaphoid fracture and normal initial radiographs', '180 adult patients with a clinically suspected scaphoid fracture and normal initial radiographs']","['supportive bandage', 'supportive bandage or 2 weeks of below-elbow cast', 'supportive bandage or CasT? ']","['functional outcome after 3 months, assessed with the Quick Disability of the Arm, Shoulder and Hand score', 'functional outcome, recovery of function, pain, patient satisfaction, quality of life and cost-effectiveness measured by medical consumption, absence from work or decreased productivity', 'functional outcome and cost-effectiveness']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0272654', 'cui_str': 'Fracture of scaphoid bone of wrist'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C1306645', 'cui_str': 'Plain radiography'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0004726', 'cui_str': 'Bandage'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0438837', 'cui_str': 'Below elbow cast'}, {'cui': 'C0179686', 'cui_str': 'Cast'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0599766', 'cui_str': 'Recovery of Function'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}]",180.0,0.122788,"The primary outcome is the functional outcome after 3 months, assessed with the Quick Disability of the Arm, Shoulder and Hand score.","[{'ForeName': 'Abigael', 'Initials': 'A', 'LastName': 'Cohen', 'Affiliation': 'Department of Orthopaedics, Erasmus MC, Rotterdam, Zuid-Holland, The Netherlands a.cohen.1@erasmusmc.nl.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Reijman', 'Affiliation': 'Department of Orthopaedics, Erasmus MC, Rotterdam, Zuid-Holland, The Netherlands.'}, {'ForeName': 'Gerald A', 'Initials': 'GA', 'LastName': 'Kraan', 'Affiliation': 'Department of Orthopaedics, Reinier de Graaf Hospital, Delft, Zuid-Holland, The Netherlands.'}, {'ForeName': 'Nina M C', 'Initials': 'NMC', 'LastName': 'Mathijssen', 'Affiliation': 'Department of Orthopaedics, Reinier de Graaf Hospital, Delft, Zuid-Holland, The Netherlands.'}, {'ForeName': 'Marc A', 'Initials': 'MA', 'LastName': 'Koopmanschap', 'Affiliation': 'Erasmus School of Health Policy and Management, Erasmus University Rotterdam, Rotterdam, Zuid-Holland, The Netherlands.'}, {'ForeName': 'Jan A N', 'Initials': 'JAN', 'LastName': 'Verhaar', 'Affiliation': 'Department of Orthopaedics, Erasmus MC, Rotterdam, Zuid-Holland, The Netherlands.'}, {'ForeName': 'Sander', 'Initials': 'S', 'LastName': 'Mol', 'Affiliation': 'Department of Emergency Medicine, Franciscus Gasthuis en Vlietland, Rotterdam, Zuid-Holland, The Netherlands.'}, {'ForeName': 'Joost W', 'Initials': 'JW', 'LastName': 'Colaris', 'Affiliation': 'Department of Orthopaedics, Erasmus MC, Rotterdam, Zuid-Holland, The Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2020-036998']
3049,33001556,Association of a glucagon-like peptide-1 receptor gene variant with glucose response to a mixed meal.,"Dipeptidyl peptidase-4 (DPP-4) inhibitors increase endogenous glucagon-like peptide-1 (GLP-1). We hypothesized that genetic variation in the gene encoding the GLP-1 receptor (GLP1R) could affect the metabolic response to DPP-4 inhibition. To evaluate the relationship between the GLP1R rs6923761 variant (G-to-A nucleic acid substitution) and metabolic responses, we performed mixed meal studies in individuals with type 2 diabetes mellitus and hypertension after 7-day treatment with placebo and the DPP-4 inhibitor sitagliptin. This analysis is a substudy of NCT02130687. The genotype frequency was 13:12:7 GG:GA:AA among individuals of European ancestry. Postprandial glucose excursion was significantly decreased in individuals carrying the rs6923761 variant (GA or AA) as compared with GG individuals during both placebo (P = 0.001) and sitagliptin treatment (P = 0.045), while intact GLP-1 levels were similar among the genotype groups. In contrast, sitagliptin lowered postprandial glucose to a greater degree in GG as compared with GA/AA individuals (P = 0.035). The relationship between GLP1R rs6923761 genotype and therapies that modulate GLP-1 signalling merits study in large populations.",2020,"Post-prandial glucose excursion was significantly decreased in individuals carrying the rs6923761 variant (GA or AA) as compared with GG individuals during both placebo (P=0.001) and sitagliptin treatment (P=0.045), while intact GLP-1 levels were similar among the genotype groups.","['individuals of European ancestry', 'individuals with type 2 diabetes mellitus and hypertension after seven-day treatment with placebo and the DPP4 inhibitor sitagliptin']","['placebo', 'Dipeptidyl peptidase-4 (DPP4) inhibitors']","['intact GLP-1 levels', 'Post-prandial glucose excursion']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1827106', 'cui_str': 'Dipeptidyl peptidase IV inhibitor'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0081937', 'cui_str': 'Dipeptidyl peptidase IV'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}]",,0.0555337,"Post-prandial glucose excursion was significantly decreased in individuals carrying the rs6923761 variant (GA or AA) as compared with GG individuals during both placebo (P=0.001) and sitagliptin treatment (P=0.045), while intact GLP-1 levels were similar among the genotype groups.","[{'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Mashayekhi', 'Affiliation': 'Division of Endocrinology, Diabetes, and Metabolism, Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Jessica R', 'Initials': 'JR', 'LastName': 'Wilson', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, University of Pennsylvania Department of Medicine, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Jafarian-Kerman', 'Affiliation': 'Division of Applied Regulatory Science, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Nian', 'Affiliation': 'Department of Biostatistics, Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Chang', 'Initials': 'C', 'LastName': 'Yu', 'Affiliation': 'Department of Biostatistics, Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Megan M', 'Initials': 'MM', 'LastName': 'Shuey', 'Affiliation': 'Division of Genetic Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Luther', 'Affiliation': 'Division of Clinical Pharmacology, Vanderbilt Department of Medicine, Nashville, Tennessee, USA.'}, {'ForeName': 'Nancy J', 'Initials': 'NJ', 'LastName': 'Brown', 'Affiliation': 'Division of Clinical Pharmacology, Vanderbilt Department of Medicine, Nashville, Tennessee, USA.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14216']
3050,32998924,Topical chlorhexidine 0.2% versus topical natamycin 5% for fungal keratitis in Nepal: rationale and design of a randomised controlled non-inferiority trial.,"INTRODUCTION


Fungal infections of the cornea, fungal keratitis (FK), are challenging to treat. Current topical antifungals are not always effective and are often unavailable, particularly in low-income and middle-income countries where most cases occur. Topical natamycin 5% is usually first-line treatment, however, even when treated intensively, infections may progress to perforation of the eye in around a quarter of cases. Alternative antifungal medications are needed to treat this blinding disease.Chlorhexidine is an antiseptic agent with antibacterial and antifungal properties. Previous pilot studies suggest that topical chlorhexidine 0.2% compares favourably with topical natamycin. Full-scale randomised controlled trials (RCTs) of topical chlorhexidine 0.2% are warranted to answer this question definitively.
METHODS AND ANALYSIS


We will test the hypothesis that topical chlorhexidine 0.2% is non-inferior to topical natamycin 5% in a two-arm, single-masked RCT. Participants are adults with FK presenting to a tertiary ophthalmic hospital in Nepal. Baseline assessment includes history, examination, photography, in vivo confocal microscopy and cornea scrapes for microbiology. Participants will be randomised to alternative topical antifungal treatments (topical chlorhexidine 0.2% and topical natamycin 5%; 1:1 ratio, 2-6 random block size). Patients are reviewed at day 2, day 7 (with reculture), day 14, day 21, month 2 and month 3. The primary outcome is the best spectacle corrected visual acuity (BSCVA) at 3 months. Primary analysis (intention to treat) will be by linear regression, with treatment arm and baseline BSCVA prespecified covariates. Secondary outcomes include epithelial healing time, scar/infiltrate size, ulcer depth, hypopyon size, perforation and/or therapeutic penetrating keratoplasty (corneal transplant), positive reculture rate (day 7) and quality of life (EuroQol-5 dimensions, WHO/PBD-VF20, WHOQOL-BREF).
ETHICS AND DISSEMINATION


The Nepal Health Research Council, the Nepal Department of Drug Administration and the London School of Hygiene and Tropical Medicine ethics committee have approved the trial. The results will be presented at local and international meetings and submitted to peer-reviewed journals for publication.
TRIAL REGISTRATION NUMBER


ISRCTN14332621; pre-results.",2020,"Secondary outcomes include epithelial healing time, scar/infiltrate size, ulcer depth, hypopyon size, perforation and/or therapeutic penetrating keratoplasty (corneal transplant), positive reculture rate (day 7) and quality of life (EuroQol-5 dimensions, WHO/PBD-VF20, WHOQOL-BREF).
","['Participants are adults with FK presenting to a tertiary ophthalmic hospital in Nepal', 'fungal keratitis in Nepal']","['Topical chlorhexidine', 'topical natamycin', 'Topical natamycin', 'topical chlorhexidine', 'Chlorhexidine']","['epithelial healing time, scar/infiltrate size, ulcer depth, hypopyon size, perforation and/or therapeutic penetrating keratoplasty (corneal transplant), positive reculture rate (day 7) and quality of life (EuroQol-5 dimensions, WHO/PBD-VF20, WHOQOL-BREF', 'best spectacle corrected visual acuity (BSCVA', 'history, examination, photography, in vivo confocal microscopy and cornea scrapes for microbiology']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1262117', 'cui_str': 'Fungal keratitis'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0027689', 'cui_str': 'Nepal'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0027444', 'cui_str': 'Natamycin'}]","[{'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0020641', 'cui_str': 'Hypopyon'}, {'cui': 'C0549099', 'cui_str': 'Perforation'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0010042', 'cui_str': 'Keratoplasty'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C1832200', 'cui_str': 'Peroxisome biogenesis disorder'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031749', 'cui_str': 'Photography'}, {'cui': 'C0242842', 'cui_str': 'Confocal Microscopy'}, {'cui': 'C0010031', 'cui_str': 'Corneal structure'}, {'cui': 'C0184933', 'cui_str': 'Scraping'}, {'cui': 'C0025952', 'cui_str': 'Microbiology'}]",,0.275982,"Secondary outcomes include epithelial healing time, scar/infiltrate size, ulcer depth, hypopyon size, perforation and/or therapeutic penetrating keratoplasty (corneal transplant), positive reculture rate (day 7) and quality of life (EuroQol-5 dimensions, WHO/PBD-VF20, WHOQOL-BREF).
","[{'ForeName': 'Jeremy John', 'Initials': 'JJ', 'LastName': 'Hoffman', 'Affiliation': 'International Centre for Eye Health, London School of Hygiene and Tropical Medicine, London, UK jeremy.hoffman@lshtm.ac.uk.'}, {'ForeName': 'Reena', 'Initials': 'R', 'LastName': 'Yadav', 'Affiliation': 'Cornea Department, Sagarmatha Choudhary Eye Hospital, Lahan, Nepal.'}, {'ForeName': 'Sandip', 'Initials': 'S', 'LastName': 'Das Sanyam', 'Affiliation': 'Cornea Department, Sagarmatha Choudhary Eye Hospital, Lahan, Nepal.'}, {'ForeName': 'Pankaj', 'Initials': 'P', 'LastName': 'Chaudhary', 'Affiliation': 'Cornea Department, Sagarmatha Choudhary Eye Hospital, Lahan, Nepal.'}, {'ForeName': 'Abhishek', 'Initials': 'A', 'LastName': 'Roshan', 'Affiliation': 'Cornea Department, Sagarmatha Choudhary Eye Hospital, Lahan, Nepal.'}, {'ForeName': 'Sanjay Kumar', 'Initials': 'SK', 'LastName': 'Singh', 'Affiliation': 'Eastern Region Eye Care Programme, Biratnagar, Nepal.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Arunga', 'Affiliation': 'International Centre for Eye Health, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Einoti', 'Initials': 'E', 'LastName': 'Matayan', 'Affiliation': 'Department of Ophthalmology, Kilimanjaro Christian Medical Centre, Moshi, Tanzania.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Macleod', 'Affiliation': 'MRC Tropical Epidemiology Group, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Helen Anne', 'Initials': 'HA', 'LastName': 'Weiss', 'Affiliation': 'MRC Tropical Epidemiology Group, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Leck', 'Affiliation': 'International Centre for Eye Health, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Hu', 'Affiliation': 'International Centre for Eye Health, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Burton', 'Affiliation': 'International Centre for Eye Health, London School of Hygiene and Tropical Medicine, London, UK.'}]",BMJ open,['10.1136/bmjopen-2020-038066']
3051,32998926,"Treat-to-target strategy with secukinumab as a first-line biological disease modifying anti-rheumatic drug compared to standard-of-care treatment in patients with active axial spondyloarthritis: protocol for a randomised open-label phase III study, AScalate.","INTRODUCTION


In patients with axial spondyloarthritis (axSpA), biological disease-modifying anti-rheumatic drugs (bDMARDs) are recommended to those with inadequate response or contraindications to non-steroidal anti-inflammatory drugs (NSAIDs). In case of failure of the first bDMARD, a switch within the class or to other bDMARD is recommended. Despite these treatment options, there is no optimal treat-to-target (T2T) strategy. This study aims to evaluate the efficacy of a T2T strategy in patients with axSpA, with secukinumab as a first-line bDMARD, compared with standard-of-care (SOC) treatment.
METHODS AND ANALYSES


This is a randomised, parallel-group, open-label, multicentre ongoing study in patients with axSpA who are naïve to bDMARD and who have had an inadequate response to NSAIDs. The study will include an 8-week screening period, a 36-week treatment period and a 20-week safety follow-up period. At baseline, patients will be randomised (1:1) to T2T or SOC group. In the T2T group, patients will be treated with secukinumab 150 mg subcutaneous (s.c.) weekly until week 4 and then at week 8. For non-responders (patients without Ankylosing Spondylitis Disease Activity Score [ASDAS] clinically important improvement; change from baseline ≥1.1) at week 12, dose will be escalated to 300 mg s.c. every 4 weeks until week 24. Non-responders at week 24 will be switched to adalimumab biosimilar 40 mg s.c. every 2 weeks until week 34. In the SOC group, patients will receive treatment at the discretion of the physician. The primary endpoint is the proportion of patients achieving an Assessment in SpondyloArthritis International Society 40% (ASAS40) response at week 24.
ETHICS AND DISSEMINATION


The study is being conducted as per the ethical principles of the Declaration of Helsinki and after approval from independent ethics committees/institutional review boards. The first results are expected to be published in early 2022.
TRIAL REGISTRATION NUMBER


This study is registered with ClinicalTrials.gov, NCT03906136.",2020,"For non-responders (patients without Ankylosing Spondylitis Disease Activity Score [ASDAS] clinically important improvement; change from baseline ≥1.1) at week 12, dose will be escalated to 300 mg s.c.","['patients with active axial spondyloarthritis', 'patients with axSpA who are naïve to bDMARD and who have had an inadequate response to NSAIDs', 'patients with axSpA, with secukinumab as a first-line bDMARD, compared with standard-of-care (SOC) treatment', 'patients with axial spondyloarthritis (axSpA), biological disease-modifying anti-rheumatic drugs (bDMARDs']",['secukinumab'],['proportion of patients achieving an Assessment in SpondyloArthritis International Society 40% (ASAS40) response'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C3203547', 'cui_str': 'Axial spondyloarthritis'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C3179547', 'cui_str': 'secukinumab'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0003191', 'cui_str': 'Antirheumatic agent'}]","[{'cui': 'C3179547', 'cui_str': 'secukinumab'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0949690', 'cui_str': 'Arthritis of spine'}, {'cui': 'C0037455', 'cui_str': 'Societies'}]",,0.10501,"For non-responders (patients without Ankylosing Spondylitis Disease Activity Score [ASDAS] clinically important improvement; change from baseline ≥1.1) at week 12, dose will be escalated to 300 mg s.c.","[{'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Poddubnyy', 'Affiliation': 'Head of the Rheumatology Unit Clinic of Gastroenterology, Infectious Diseases and Rheumatology, Charité Universitätsmedizin Berlin, Berlin, Germany denis.poddubnyy@charite.de.'}, {'ForeName': 'Ludwig', 'Initials': 'L', 'LastName': 'Hammel', 'Affiliation': 'Deutsche Vereinigung Morbus Bechterew e.V, Schweinfurt, Germany.'}, {'ForeName': 'Marvin', 'Initials': 'M', 'LastName': 'Heyne', 'Affiliation': 'Immunology, Hepatology and Dermatology Franchise, Novartis Pharma GmbH, Nuremberg, Germany.'}, {'ForeName': 'Justyna', 'Initials': 'J', 'LastName': 'Veit', 'Affiliation': 'Immunology, Hepatology and Dermatology Franchise, Novartis Pharma GmbH, Nuremberg, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Jentzsch', 'Affiliation': 'Immunology, Hepatology and Dermatology Franchise, Novartis Pharma GmbH, Nuremberg, Germany.'}, {'ForeName': 'Xenofon', 'Initials': 'X', 'LastName': 'Baraliakos', 'Affiliation': 'Rheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum, Bochum, Germany.'}]",BMJ open,['10.1136/bmjopen-2020-039059']
3052,32998931,Pancreatic resection with perioperative drug repurposing of propranolol and etodolac: trial protocol of the phase-II randomised placebo controlled PROSPER trial.,"INTRODUCTION


Pancreatic cancer is the fourth-leading cause of cancer-related death in developed countries. Despite advances in systemic chemotherapy, the mainstay of curative therapy for non-metastatic disease is surgical resection. However, the perioperative period is characterised by stress and inflammatory reactions that can contribute to metastatic spread and disease recurrence. Catecholamines and prostaglandins play a crucial role in these reactions. Therefore, a drug repurposing of betablockers and cyclooxygenase inhibitors seems reasonable to attenuate tumour-associated inflammation by inhibiting psychological, surgical and inflammatory stress responses. This may cause a relevant antitumourigenic and antimetastatic effect during the perioperative period, a window for cancer-directed therapy that is currently largely unexploited.
METHODS AND ANALYSIS


This is a prospective, single-centre, two-arm randomised, patient and observer blinded, placebo-controlled, phase-II trial evaluating safety and feasibility of combined perioperative treatment with propranolol and etodolac in adult patients with non-metastatic cancer of the pancreatic head undergoing elective pancreatoduodenectomy. 100 patients fulfilling the eligibility criteria will be randomised to perioperative treatment for 25 days perioperatively with a combination of propranolol and etodolac or placebo. Primary outcome of interest will be safety in terms of serious adverse events and reactions within 3 months. Furthermore, adherence to trial medication will be assessed as feasibility outcomes. Preliminary efficacy data will be evaluated for the purpose of power calculation for a potential subsequent phase-III trial. The clinical trial is accompanied by a translational study investigating the mechanisms of action of the combined therapy on a molecular basis.
ETHICS AND DISSEMINATION


The PROSPER-trial has been approved by the German Federal Institute for Drugs and Medical Devices (reference number 4042875) and the Ethics Committee of the Medical Faculty of the University of Heidelberg (reference number AFmo-385/2018). The final trial results will be published in a peer-reviewed journal and will be presented at appropriate national and international conferences.
TRIAL REGISTRATION NUMBERS


DRKS00014054; EudraCT number: 2018-000415-25.",2020,Primary outcome of interest will be safety in terms of serious adverse events and reactions within 3 months.,"['100 patients fulfilling the eligibility criteria', 'adult patients with non-metastatic cancer of the pancreatic head undergoing elective pancreatoduodenectomy']","['propranolol and etodolac or placebo', 'propranolol and etodolac', 'cyclooxygenase inhibitors', 'placebo']",['safety in terms of serious adverse events and reactions within 3 months'],"[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0227579', 'cui_str': 'Structure of head of pancreas'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0085162', 'cui_str': 'Pancreaticoduodenectomy'}]","[{'cui': 'C0033497', 'cui_str': 'Propranolol'}, {'cui': 'C0059865', 'cui_str': 'Etodolac'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0085387', 'cui_str': 'Cyclooxygenase inhibitor'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",,0.267369,Primary outcome of interest will be safety in terms of serious adverse events and reactions within 3 months.,"[{'ForeName': 'Felix J', 'Initials': 'FJ', 'LastName': 'Hüttner', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Ilse', 'Initials': 'I', 'LastName': 'Rooman', 'Affiliation': 'The Anticancer Fund, Brussels, Belgium.'}, {'ForeName': 'Gauthier', 'Initials': 'G', 'LastName': 'Bouche', 'Affiliation': 'The Anticancer Fund, Brussels, Belgium.'}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Knebel', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Hüsing', 'Affiliation': 'Coordination Center for Clinical Trials, Heidelberg University, Heidelberg, Germany.'}, {'ForeName': 'André L', 'Initials': 'AL', 'LastName': 'Mihaljevic', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Thilo', 'Initials': 'T', 'LastName': 'Hackert', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Strobel', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Markus W', 'Initials': 'MW', 'LastName': 'Büchler', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Germany markus.buechler@med.uni-heidelberg.de.'}, {'ForeName': 'Markus K', 'Initials': 'MK', 'LastName': 'Diener', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Germany.'}]",BMJ open,['10.1136/bmjopen-2020-040406']
3053,32998932,"Single postoperative infusion of zoledronic acid to improve patient-reported outcome after hip or knee replacement: study protocol for a randomised, controlled, double-blinded clinical trial.","INTRODUCTION


In Sweden, roughly 3000 patients are reoperated each year due to pain and loss of function related to a loosened hip or knee prosthesis. These reoperations are strenuous for the patient, technically demanding and costly for the healthcare system. Any such reoperation that can be prevented would be of great benefit. Bisphosphonates are drugs that inhibit osteoclast function. Several clinical trials suggest that bisphosphonates lead to improved implant fixation and one small study even indicates better functional outcome. Furthermore, in epidemiological studies, bisphosphonates have been shown to decrease the rate of revision for aseptic loosening by half. Thus, there are several indirect indications that bisphosphonates could improve patient-reported outcome, but no firm evidence.
METHODS AND ANALYSIS


This is a pragmatic randomised, placebo-controlled, double-blinded, academic clinical trial of a single postoperative dose of zoledronic acid, in patients younger than 80 years undergoing primary total hip or knee replacement for osteoarthritis. Participants will be recruited from two orthopaedic departments. All surgeries will be performed, and study drugs given at Motala Hospital, Sweden. The primary endpoint is to investigate between-group differences in the Hip dysfunction and Osteoarthritis Outcome Score and the Knee injury and Osteoarthritis Outcome Score at 3-year follow-up. Secondary outcomes will be investigated at 1 year, 3 years and 6 years, and stratified for hip and knee implants. These secondary endpoints are supportive, exploratory or explanatory. A total of 1000 patients will be included in the study.
ETHICS AND DISSEMINATION


The study has been approved by the Regional Ethical Review Board in Linköping (DNR 2015/286-31). The study will be reported in accordance with the Consolidated Standards of Reporting Trials statement for pharmacological trials. The results will be submitted for publication in peer-reviewed academic journals and disseminated to patient organisations and the media.
TRIAL REGISTRATION NUMBER


EudraCT: No 2015-001200-55; Pre-results.",2020,The primary endpoint is to investigate between-group differences in the Hip dysfunction and Osteoarthritis Outcome Score and the Knee injury and Osteoarthritis Outcome Score at 3-year follow-up.,"['Participants will be recruited from two orthopaedic departments', '1000 patients will be included in the study', 'patients younger than 80 years undergoing primary total hip or knee replacement for osteoarthritis']","['bisphosphonates', 'placebo', 'Bisphosphonates', 'zoledronic acid']","['pain and loss of function', 'rate of revision for aseptic loosening', 'Hip dysfunction and Osteoarthritis Outcome Score and the Knee injury and Osteoarthritis Outcome Score']","[{'cui': 'C0587525', 'cui_str': 'Orthopedic department'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}]","[{'cui': 'C0012544', 'cui_str': 'Bisphosphonate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0257685', 'cui_str': 'zoledronic acid'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0439616', 'cui_str': 'Revisions'}, {'cui': 'C0232920', 'cui_str': 'Sterile'}, {'cui': 'C0333050', 'cui_str': 'Loosening'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3476088', 'cui_str': 'Knee Injury and Osteoarthritis Outcome Score'}]",1000.0,0.415491,The primary endpoint is to investigate between-group differences in the Hip dysfunction and Osteoarthritis Outcome Score and the Knee injury and Osteoarthritis Outcome Score at 3-year follow-up.,"[{'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Brandt', 'Affiliation': 'Department of Orthopaedic Surgery, Capio Specialistvård Motala, Motala, Sweden.'}, {'ForeName': 'Håkan', 'Initials': 'H', 'LastName': 'Ledin', 'Affiliation': 'Department of Orthopaedic Surgery, Capio Specialistvård Motala, Motala, Sweden.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Ranstam', 'Affiliation': 'Department of Clinical sciences, Lund University, Lund, Sweden.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Roos', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, Syddansk Universitet Det Sundhedsvidenskabelige Fakultet, Odense, Denmark.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Aspenberg', 'Affiliation': 'Department of Orthopaedic Surgery, Linköping University Hospital, Linköping, Sweden.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Schilcher', 'Affiliation': 'Department of Orthopaedic Surgery, Linköping University Hospital, Linköping, Sweden jorg.schilcher@liu.se.'}]",BMJ open,['10.1136/bmjopen-2020-040985']
3054,33002553,Comparative clinical study evaluating the effect of adding Vildagliptin versus Glimepiride to ongoing Metformin therapy on diabetic patients with symptomatic coronary artery disease.,"BACKGROUND AND OBJECTIVE


Cardiovascular diseases (CVDs) remain the most identified cause of death in patients with diabetes mellitus (DM). This study aimed to evaluate the effect of adding Vildagliptin versus Glimepiride to ongoing Metformin on the biomarkers of inflammation, thrombosis, and atherosclerosis in T2DM patients with symptomatic coronary artery disease (CAD).
METHODS


This study included 80 patients with uncontrolled T2DM and symptomatic CAD who were randomized to add either Vildagliptin 50 mg/day ""group I"" or Glimepiride 4 mg/day ""group II"" to ongoing Metformin therapy (1000 mg/day). Blood samples were collected at baseline and 3 months after intervention for biochemical analysis of HbA1c %, IL-1β, adiponectin, hsCRP and lipid profile. Additionally atherogenic index (AI) and coronary risk index (CRI) were determined.
RESULTS


Three months after intervention and as compared to group II (Glimepiride/Metformin), group 1 (Vildagliptin/Metformin) showed significantly lower BMI (28.73 ± 3.48 versus 30.55 ± 3.15; p = 0.02), HbA1c (6.05 ± 0.72 versus 7.06 ± 0.89; p < 0.0001), hsCRP (0.96 ± 0.20 versus 1.72 ± 0.38; p < 0.0001), IL-1β (34.95 ± 10.01 versus 45.13 ± 10.26; p < 0.0001), TC (136 ± 23.45 versus 169 ± 35.72; p < 0.0001), TG (116 ± 29.10 versus 146 ± 56.58; p = 0.005), and CRI (2.47 ± 0.90 versus 3.65 ± 1.19; p < 0.0001) which was associated with significantly higher adiponectin and HDL-C (4.42 ± 1.29 versus 2.52 ± 1.86; p < 0.0001 and 61 ± 23.04 versus 48 ± 12.92; p = 0.003 respectively).
CONCLUSION


In patients with T2DM and symptomatic CAD, the addition of Vildagliptin to ongoing metformin showed better glycemic control, lower inflammatory markers (IL-1β and hsCRP), higher protective markers (adiponectin and HDL-C) and improved lipid profile compared to Glimepiride/metformin therapy.",2020,"In patients with T2DM and symptomatic CAD, the addition of Vildagliptin to ongoing metformin showed better glycemic control, lower inflammatory markers (IL-1β and hsCRP), higher protective markers (adiponectin and HDL-C) and improved lipid profile compared to Glimepiride/metformin therapy.","['T2DM patients with symptomatic coronary artery disease (CAD', 'patients with diabetes mellitus (DM', '80 patients with uncontrolled T2DM and symptomatic CAD', 'Diabetic Patients with Symptomatic Coronary Artery Disease']","['Vildagliptin', 'Glimepiride', 'Glimepiride/metformin', 'Vildagliptin 50 mg/day ""group', 'Metformin therapy', 'Glimepiride/Metformin', 'Vildagliptin/Metformin', 'Metformin Therapy', 'Metformin']","['BMI', 'CRI', 'Additionally atherogenic index (AI) and coronary risk index (CRI', 'glycemic control, lower inflammatory markers (IL-1β and hsCRP), higher protective markers (adiponectin and HDL-C) and improved lipid profile', 'Blood samples', 'adiponectin and HDL-C', 'biomarkers of inflammation, thrombosis, and atherosclerosis', 'hsCRP', 'IL-1β']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}]","[{'cui': 'C1570906', 'cui_str': 'vildagliptin'}, {'cui': 'C0061323', 'cui_str': 'glimepiride'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C2240780', 'cui_str': 'vildagliptin 50 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}]",80.0,0.0534605,"In patients with T2DM and symptomatic CAD, the addition of Vildagliptin to ongoing metformin showed better glycemic control, lower inflammatory markers (IL-1β and hsCRP), higher protective markers (adiponectin and HDL-C) and improved lipid profile compared to Glimepiride/metformin therapy.","[{'ForeName': 'Rehab', 'Initials': 'R', 'LastName': 'Werida', 'Affiliation': 'Clinical Pharmacy & Pharmacy Practice Department, Faculty of Pharmacy, Damanhour University, Egypt. Electronic address: rehabwrieda@pharm.dmu.edu.eg.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Kabel', 'Affiliation': 'Clinical Pharmacy Unit, Alexandria Armed Forces Hospital, Egypt.'}, {'ForeName': 'Gamal', 'Initials': 'G', 'LastName': 'Omran', 'Affiliation': 'Biochemistry Department, Faculty of Pharmacy, Damanhour University, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Shokry', 'Affiliation': 'Cardiology Department, Alexandria Armed Forces Hospital, Egypt.'}, {'ForeName': 'Tarek', 'Initials': 'T', 'LastName': 'Mostafa', 'Affiliation': 'Clinical Pharmacy Department, Faculty of Pharmacy, Tanta University, Egypt.'}]",Diabetes research and clinical practice,['10.1016/j.diabres.2020.108473']
3055,33002792,Collaborative Care Model Based Telerehabilitation Exercise Training Program for Acute Stroke Patients in China: A Randomized Controlled Trial.,"BACKGROUND


Early rehabilitation has been proved very important for stroke patients. However, the effective model of transitioning from early in-hospital rehabilitation to discharge rehabilitation using the collaborative remote rehabilitation nursing model has not been thoroughly studied.
OBJECTIVE


To explore the feasibility and effectiveness of collaborative care model based telerehabilitation exercise training for acute stroke patients.
METHODS


A randomized controlled clinical trial was conducted. Patients were recruited and randomly divided into intervention and control group. Both groups were given regular treatment and acute rehabilitation nursing instructions during hospitalization. The control group was followed by regular telephone follow-up after discharge. The intervention group received Internet-based remote rehabilitation project after discharge. Motor function, balance ability and quality of life were measured at the day of discharge, the 4 th  week, 8 th  week and 12 th  week after patients were discharged. The CONSORT checklist was used to check the procedure.
RESULTS


A total of 61 patients completed the study, 30 cases in the intervention group and 31 cases in the control group. Both groups were significantly improved in terms of motor function and quality of life, but the intervention group showed greater improvement in Fugl-Meyer Motor Function Assessment (intervention group = 83.70 ± 4.44, control group = 75.29 ± 2.89), Berg Balance Scale (intervention group = 43.13 ± 2.32, control group = 38.29 ± 2.70) and Stroke-Specific Quality of Life Scale (intervention group = 190.57 ± 5.09, control group = 175.90 ± 5.78). Group-time interaction was significant in motor function and quality of life.
CONCLUSION


Collaborative care model based telerehabilitation exercise training program can safely and effectively improve the recovery of motor function and improve the quality of life in patients with stroke.",2020,"Both groups were significantly improved in terms of motor function and quality of life, but the intervention group showed greater improvement in Fugl-Meyer Motor Function Assessment (intervention group = 83.70 ± 4.44, control group = 75.29 ± 2.89), Berg Balance Scale (intervention group = 43.13 ± 2.32, control group = 38.29 ± 2.70) and Stroke-Specific Quality of Life Scale (intervention group = 190.57 ± 5.09, control group = 175.90 ± 5.78).","['Acute Stroke Patients in China', 'acute stroke patients', 'stroke patients', '61 patients completed the study, 30 cases in the intervention group and 31 cases in the control group', 'patients with stroke']","['Collaborative Care Model Based Telerehabilitation Exercise Training Program', 'collaborative care model based telerehabilitation exercise training', 'Internet-based remote rehabilitation project']","['Fugl-Meyer Motor Function Assessment', 'Berg Balance Scale', 'motor function and quality of life', 'Motor function, balance ability and quality of life', 'quality of life', 'Stroke-Specific Quality of Life Scale', 'recovery of motor function']","[{'cui': 'C0751956', 'cui_str': 'Acute stroke'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4042802', 'cui_str': 'Remote Rehabilitation'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}]","[{'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0560184', 'cui_str': 'Ability to balance'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}]",61.0,0.0446921,"Both groups were significantly improved in terms of motor function and quality of life, but the intervention group showed greater improvement in Fugl-Meyer Motor Function Assessment (intervention group = 83.70 ± 4.44, control group = 75.29 ± 2.89), Berg Balance Scale (intervention group = 43.13 ± 2.32, control group = 38.29 ± 2.70) and Stroke-Specific Quality of Life Scale (intervention group = 190.57 ± 5.09, control group = 175.90 ± 5.78).","[{'ForeName': 'Zhishui', 'Initials': 'Z', 'LastName': 'Wu', 'Affiliation': 'Department of neurology, the Third Affiliated Hospital of Soochow University, Changzhou, Jiangsu, China. Electronic address: 958414840@qq.com.'}, {'ForeName': 'Jingjuan', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Outpatient Office, the Third Affiliated Hospital of Soochow University, Changzhou, Jiangsu, China. Electronic address: 13255107918@163.com.'}, {'ForeName': 'Chunxian', 'Initials': 'C', 'LastName': 'Yue', 'Affiliation': 'Department of neurology, the Third Affiliated Hospital of Soochow University, Changzhou, Jiangsu, China. Electronic address: 1210906885@qq.com.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Tzu Chi elderly care service center, Changzhou, Jiangsu, China. Electronic address: 18262284203@qq.com.'}, {'ForeName': 'Yongchun', 'Initials': 'Y', 'LastName': 'Liang', 'Affiliation': 'School of nursing, Taihu University of Wuxi, Wuxi, Jiangsu, China. Electronic address: yongchun0526@163.com.'}]",Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association,['10.1016/j.jstrokecerebrovasdis.2020.105328']
3056,33002839,A body-weight-supported visual feedback system for gait recovering in stroke patients: A randomized controlled study.,"OBJECTIVE


The aim of this study was to determine the effectiveness of a novel body-weight-supported (BWS) gait training system with visual feedback, called Copernicus® (Rehalife, Italy). This computerized device provides comfortable, regular and repeatable locomotion in hemiplegic patients. Through visual real-time monitoring of gait parameters, patients are trained to transfer weight loading alternately on both feet.
DESIGN


A single-blind, randomized controlled study. A single center used a computer-generated randomization code to allocate treatments.
SETTING


Intensive rehabilitation unit (IRU) at the Institute S. Anna (Italy).
PARTICIPANTS


63 first-ever stroke patients (39 men, age: 66.1 ± 9.6 years; 61.6 % with left-sided lesion) randomly distributed into three demographically/clinically matched groups.
TREATMENTS


All groups were treated five times a week for 2 -h sessions for six consecutive weeks. The first group (""control"") underwent a conventional physical therapy; the second group performed advanced BWS gait training sessions without visual feedback (Experimental VF- group); whereas the third group used BWS with visual feedback stimulation (Experimental VF+ group).
MAIN OUTCOME MEASURES


Absolute changes were recorded using conventional clinical scales and kinematic measurement of static gait balance from baseline to follow-up.
RESULTS


Significant interaction Group*Time effects scales (F 2,126  = 5.1, p-level = 0.005, η² p  = 0.25; F 2,126  = 4.7, p-level = 0.007, η² p  = 0.19; respectively) were detected in the Functional Independence Measure and Tinetti-Balance scales. Post hoc analysis demonstrated that the recovery of motor functioning was greater for the VF + group with respect to other groups (all p's ≤ 0.001). A similar pattern of findings was also obtained with a stabilometric analysis, demonstrating a better clinical improvement in static balance after VF + treatment.
CONCLUSION


The proposed advanced rehabilitation system with visual feedback was more effective in improving gait recovery with respect to conventional and high-tech therapies without a sensor feedback.",2020,The proposed advanced rehabilitation system with visual feedback was more effective in improving gait recovery with respect to conventional and high-tech therapies without a sensor feedback.,"['hemiplegic patients', 'Intensive rehabilitation unit (IRU) at the Institute S. Anna (Italy', 'gait recovering in stroke patients', '63 first-ever stroke patients (39 men, age: 66.1 ± 9.6 years; 61.6 % with left-sided lesion) randomly distributed into three demographically/clinically matched groups']","['conventional physical therapy; the second group performed advanced BWS gait training sessions without visual feedback (Experimental VF- group); whereas the third group used BWS with visual feedback stimulation (Experimental VF+ group', 'novel body-weight-supported (BWS) gait training system with visual feedback, called Copernicus® (Rehalife, Italy', 'body-weight-supported visual feedback system']","['Group*Time effects scales', 'gait recovery', 'static balance', 'Functional Independence Measure and Tinetti-Balance scales', 'conventional clinical scales and kinematic measurement of static gait balance', 'recovery of motor functioning']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0024908', 'cui_str': 'Matched Groups'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C2936181', 'cui_str': 'Visual Feedback'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0022277', 'cui_str': 'Italy'}]","[{'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0451172', 'cui_str': 'Functional independence measure'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",,0.0295403,The proposed advanced rehabilitation system with visual feedback was more effective in improving gait recovery with respect to conventional and high-tech therapies without a sensor feedback.,"[{'ForeName': 'Loris', 'Initials': 'L', 'LastName': 'Pignolo', 'Affiliation': 'S. Anna Institute, 88900, Crotone, Italy.'}, {'ForeName': 'Giuseppina', 'Initials': 'G', 'LastName': 'Basta', 'Affiliation': 'S. Anna Institute, 88900, Crotone, Italy.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Carozzo', 'Affiliation': 'S. Anna Institute, 88900, Crotone, Italy.'}, {'ForeName': 'MariaConcetta', 'Initials': 'M', 'LastName': 'Bilotta', 'Affiliation': 'S. Anna Institute, 88900, Crotone, Italy.'}, {'ForeName': 'Maria Rosaria', 'Initials': 'MR', 'LastName': 'Todaro', 'Affiliation': 'S. Anna Institute, 88900, Crotone, Italy.'}, {'ForeName': 'Sebastiano', 'Initials': 'S', 'LastName': 'Serra', 'Affiliation': 'S. Anna Institute, 88900, Crotone, Italy.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Ciancarelli', 'Affiliation': ""Department of Life, Health and Environmental Sciences, University of L'Aquila, Italy.""}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Tonin', 'Affiliation': 'S. Anna Institute, 88900, Crotone, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Cerasa', 'Affiliation': 'S. Anna Institute, 88900, Crotone, Italy; Institute for Biomedical Research and Innovation, National Research Council, (IRIB-CNR), 87050, Mangone, CS, Italy. Electronic address: antonio.cerasa76@gmail.com.'}]",Gait & posture,['10.1016/j.gaitpost.2020.09.020']
3057,33006394,Effective methylation triage of HPV positive women with abnormal cytology in a middle-income country.,"The S5-methylation test, an alternative to cytology and HPV16/18 genotyping to triage high-risk HPV-positive (hrHPV+) women, has not been widely validated in low-middle-income countries (LMICs). We compared S5 to HPV16/18 and cytology to detect cervical intraepithelial neoplasia Grade 2 or worse (CIN2+) and CIN3+ in hrHPV+ women selected from a randomized pragmatic trial of 2661 Colombian women with an earlier-borderline abnormal cytology. We included all hrHPV+ CIN2 and CIN3+ cases (n = 183) age matched to 183 <CIN2 hrHPV+. Baseline specimens were HPV-genotyped and tested by S5-methylation, blinded to cytology, histology and initial HPV results. We evaluated the test performance of predefined S5-classifier (cut-point 0.8) and a post hoc classifier at a different cut-point (3.1). S5 sensitivity for CIN2+ was 82% (95% confidence interval [CI] 76.4-87.5) and for CIN3+ 77.08% (95% CI 65.19-88.97). S5 sensitivity was higher than HPV16/18 sensitivity (48.1%, 95% CI 40.85-55.33) or cytology (31.21%, 95% CI 24.50-37.93) but with lower specificity (35%, 95% CI 28.1-42). At cut-point 3.1, S5 sensitivity for CIN2+ (55.2%, 95% CI 48-62.4) or CIN3+ (64.6%, 95% CI 51.0-78.1) was also superior to HPV16/18 (P < .05) or cytology (P < .0001). At this cut-point S5 specificity (76%, 95% CI 69.8-82.1 for <CIN2) was higher than HPV16/18 (67.21%, 95% CI 60.41-74.01, P = .0062) and similar to cytology (75.57%, 95% CI 69.34-81.79, P = 1). HPV16/18 plus cytology sensitivity was similar to S5 for CIN3+, however, false-positive rate was higher (50.27% vs. 24.04%). High sensitivity is crucial in LMICs, S5-methylation exceeded HPV16/18 or cytology sensitivity with comparable specificity for CIN2+ and CIN3+ in hrHPV-positive Colombian women. Furthermore, S5 triage had comparable sensitivity and significantly fewer false positives than cytology and HPV16/18 combination.",2020,"S5 sensitivity was higher than HPV16/18 sensitivity (48.1%, 95%CI 40.85-55.33) or cytology (31.21%, 95%CI 24.50-37.93) but with lower specificity (35%, 95%CI 28.1-42).","['We included all hrHPV+ CIN2 and CIN3+ cases (n\xa0=\xa0183) age matched to 183\u2009<\u2009CIN2 hrHPV', 'HPV positive women with abnormal cytology in a middle-income country', '2661 Colombian women with an earlier-borderline abnormal cytology']","['S5 to HPV16/18 and cytology', 'CIN3']","['HPV16/18 plus cytology sensitivity', 'S5 sensitivity for CIN2', 'false-positive rate', 'HPV16/18 sensitivity', 'S5 sensitivity', 'false positives']","[{'cui': 'C0023449', 'cui_str': 'Acute lymphoid leukemia'}, {'cui': 'C0349459', 'cui_str': 'Cervical intraepithelial neoplasia grade 2'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C4517615', 'cui_str': '183'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0010818', 'cui_str': 'Cytology'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C1279919', 'cui_str': 'Early'}]","[{'cui': 'C0010818', 'cui_str': 'Cytology'}, {'cui': 'C0851140', 'cui_str': 'Carcinoma in situ of uterine cervix'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0010818', 'cui_str': 'Cytology'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0349459', 'cui_str': 'Cervical intraepithelial neoplasia grade 2'}, {'cui': 'C0205557', 'cui_str': 'False positive'}]",2661.0,0.246189,"S5 sensitivity was higher than HPV16/18 sensitivity (48.1%, 95%CI 40.85-55.33) or cytology (31.21%, 95%CI 24.50-37.93) but with lower specificity (35%, 95%CI 28.1-42).","[{'ForeName': 'Arianis Tatiana', 'Initials': 'AT', 'LastName': 'Ramírez', 'Affiliation': 'Infection and Cancer Group, School of Medicine and Corporación Académica para el Estudio de Patologías Tropicales, Universidad de Antioquia, Medellín, Colombia.'}, {'ForeName': 'Gloria Inés', 'Initials': 'GI', 'LastName': 'Sánchez', 'Affiliation': 'Infection and Cancer Group, School of Medicine and Corporación Académica para el Estudio de Patologías Tropicales, Universidad de Antioquia, Medellín, Colombia.'}, {'ForeName': 'Belinda', 'Initials': 'B', 'LastName': 'Nedjai', 'Affiliation': 'Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Barts and the London School of Medicine, Queen Mary University of London, London, UK.'}, {'ForeName': 'María Cecilia', 'Initials': 'MC', 'LastName': 'Agudelo', 'Affiliation': 'Infection and Cancer Group, School of Medicine and Corporación Académica para el Estudio de Patologías Tropicales, Universidad de Antioquia, Medellín, Colombia.'}, {'ForeName': 'Adam R', 'Initials': 'AR', 'LastName': 'Brentnall', 'Affiliation': 'Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Barts and the London School of Medicine, Queen Mary University of London, London, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Cuschieri', 'Affiliation': ""Queen's Medical Research Institute of The University of Edinburgh, Edinburgh, UK.""}, {'ForeName': 'Kelly Melisa', 'Initials': 'KM', 'LastName': 'Castañeda', 'Affiliation': 'Infection and Cancer Group, School of Medicine and Corporación Académica para el Estudio de Patologías Tropicales, Universidad de Antioquia, Medellín, Colombia.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Cuzick', 'Affiliation': 'Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Barts and the London School of Medicine, Queen Mary University of London, London, UK.'}, {'ForeName': 'Attila T', 'Initials': 'AT', 'LastName': 'Lorincz', 'Affiliation': 'Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Barts and the London School of Medicine, Queen Mary University of London, London, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",International journal of cancer,['10.1002/ijc.33314']
3058,33007710,Working out the worries: A randomized controlled trial of high intensity interval training in generalized anxiety disorder.,"BACKGROUND


Aerobic exercise (AE) demonstrated an overall medium treatment effect in anxiety disorders (AD) but there is evidence for an ""intensity-response"" relationship. High intensity interval training (HIIT) was highly effective on a range of (mental) health parameters. However, so far no randomised-controlled trial (RCT) investigated the efficacy of HIIT in AD.
METHODS


33 patients with generalized anxiety disorder (GAD) were randomly assigned to 12-day HIIT or a training of lower intensity (LIT). Anxiety, comorbid depression, stress-related bodily symptoms and perceived control over anxiety related stimuli (PC) were assessed at baseline, post-training and 30 days after baseline by using the Penn State Worry Questionnaire (PSWQ), the Hamilton Inventories for Anxiety and Depression (Ham-A, Ham-D), the Screening for Somatoform Symptoms-7 (SOMS-7) and the Anxiety Control Questionnaire (ACQ-R).
RESULTS


Both interventions showed moderate or large effects on all clinical measures. However, effects for HIIT were generally about twice as high as for LIT. PC negatively correlated with GAD severity in the whole sample at baseline but an association of training-induced changes in PC and worrying were exclusively detectable in HIIT.
CONCLUSION


HIIT was highly effective and fast acting in GAD. Therefore, it may complement first-line treatment approaches in this condition.",2020,", the Screening for Somatoform Symptoms-7 (SOMS-7) and the Anxiety Control Questionnaire (ACQ-R).
","['generalized anxiety disorder', '33 patients with generalized anxiety disorder (GAD']","['Aerobic exercise (AE', 'High intensity interval training (HIIT', 'high intensity interval training', '12-day HIIT or a training of lower intensity (LIT']","['Anxiety, comorbid depression, stress-related bodily symptoms and perceived control over anxiety related stimuli (PC', 'Penn State Worry Questionnaire (PSWQ), the Hamilton Inventories for Anxiety and Depression', 'GAD severity', 'Screening for Somatoform Symptoms-7 (SOMS-7) and the Anxiety Control Questionnaire (ACQ-R']","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C2959752', 'cui_str': 'Penn State worry questionnaire'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",33.0,0.0824276,", the Screening for Somatoform Symptoms-7 (SOMS-7) and the Anxiety Control Questionnaire (ACQ-R).
","[{'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Plag', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Psychiatry and Psychotherapy, Charité Campus Mitte, Berlin, Germany. Electronic address: jens.plag@charite.de.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Schmidt-Hellinger', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Sports Medicine, Berlin, Germany. Electronic address: paul-juergen.schmidt@charite.de.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Klippstein', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Psychiatry and Psychotherapy, Charité Campus Mitte, Berlin, Germany. Electronic address: theresa.klippstein@charite.de.'}, {'ForeName': 'Jennifer L M', 'Initials': 'JLM', 'LastName': 'Mumm', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Psychiatry and Psychotherapy, Charité Campus Mitte, Berlin, Germany. Electronic address: jennifer.mumm@charite.de.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Wolfarth', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Sports Medicine, Berlin, Germany. Electronic address: bernd.wolfarth@charite.de.'}, {'ForeName': 'Moritz B', 'Initials': 'MB', 'LastName': 'Petzold', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Psychiatry and Psychotherapy, Charité Campus Mitte, Berlin, Germany. Electronic address: moritz.petzold@charite.de.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Ströhle', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Psychiatry and Psychotherapy, Charité Campus Mitte, Berlin, Germany. Electronic address: andreas.stroehle@charite.de.'}]",Journal of anxiety disorders,['10.1016/j.janxdis.2020.102311']
3059,33017886,Changes in body mass index in boys with central precocious puberty over 2 years of gonadotropin-releasing hormone agonist therapy.,"PURPOSE


Gonadotropin-releasing hormone agonist (GnRHa) is a safe and effective therapy used to treat central precocious puberty (CPP). Although most studies have reported no significant difference in body mass index (BMI) in girls during and after GnRHa therapy, few studies have investigated changes in BMI in boys with CPP. This study evaluated the effects of GnRHa therapy on BMI in boys with CPP.
METHODS


This study included 75 boys with CPP at Ajou University Hospital between January 1, 2007 and December 31, 2016, who treated with leuprorelin acetate or triptorelin acetate every 4 weeks for at least 2 years. The subjects were divided into 3 groups according to BMI: normal weight, overweight, and obese. We analyzed the BMI standard deviation score (SDS) in each group before therapy and after 1 year and 2 years of therapy.
RESULTS


Of the 75 boys, 37 were in the normal weight group, 21 were in the overweight group, and 17 were in the obese group. Magnetic resonance imaging that was performed before treatment showed abnormal findings in 9 boys. The mean BMI SDS for all participants at initiation was 1.0±0.8, and that in the normal weight, overweight, and obese groups was 0.3±0.4, 1.3±0.1, and 1.9±0.3, respectively. There were no significant differences in BMI SDS in any group after 1 or 2 years of treatment.
CONCLUSION


The BMI SDS in boys with CPP did not significantly change over 2 years of GnRHa therapy.",2020,"There were no significant differences in BMI SDS in any group after 1 or 2 years of treatment.
","[' 37 were in the normal weight group, 21 were in the overweight group, and 17 were in the obese group', 'boys with central precocious puberty over 2 years of', 'every 4 weeks for at least 2 years', '75 boys with CPP at Ajou University Hospital between January 1, 2007 and December 31, 2016, who treated with', '75 boys', 'boys with CPP']","['leuprorelin acetate or triptorelin acetate', 'Gonadotropin-releasing hormone agonist (GnRHa', 'Magnetic resonance imaging', 'gonadotropin-releasing hormone agonist therapy', 'GnRHa therapy']","['body mass index', 'body mass index (BMI', 'BMI SDS', 'BMI standard deviation score (SDS', 'mean BMI SDS']","[{'cui': 'C2712185', 'cui_str': 'Normal weight'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0342543', 'cui_str': 'Central precocious puberty'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1275555', 'cui_str': 'Every four weeks'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0700596', 'cui_str': 'Leuprolide acetate'}, {'cui': 'C0771825', 'cui_str': 'Triptorelin acetate'}, {'cui': 'C1518041', 'cui_str': 'Gonadotropin releasing hormone analogues'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",75.0,0.0184315,"There were no significant differences in BMI SDS in any group after 1 or 2 years of treatment.
","[{'ForeName': 'Kyung In', 'Initials': 'KI', 'LastName': 'Lim', 'Affiliation': 'Department of Pediatrics, Gachon University Gil Medical Center, Incheon, Korea.'}, {'ForeName': 'Hae Sang', 'Initials': 'HS', 'LastName': 'Lee', 'Affiliation': 'Depar tment of Pediatrics, Ajou University Hospital, Ajou University School of Medicine, Suwon, Korea.'}, {'ForeName': 'Jin Soon', 'Initials': 'JS', 'LastName': 'Hwang', 'Affiliation': 'Depar tment of Pediatrics, Ajou University Hospital, Ajou University School of Medicine, Suwon, Korea.'}]",Annals of pediatric endocrinology & metabolism,['10.6065/apem.1938176.088']
3060,33018052,Closed-loop Electroencephalogram-based modulated audio to fall and deepen sleep faster.,"The transition from wake to sleep is a continuum that is well characterized by the electroencephalogram (EEG) power spectral ratio (ρ) between the beta (15 to 30 Hz) and theta (4 to 8 Hz) bands. From wake to sleep, the value of ρ gradually decreases.We have designed and implemented a single EEG-signal based closed-loop system that leverages ρ to modulate the volume of a pink-noise type of audio such that the volume becomes gradually softer as sleep initiates. A proof-of-concept trial was conducted with this system and it was found that using this concept resulted in a reduction of sleep latency and latency to deep sleep.",2020,A proof-of-concept trial was conducted with this system and it was found that using this concept resulted in a reduction of sleep latency and latency to deep sleep.,[],['Closed-loop Electroencephalogram-based modulated audio'],['sleep latency and latency to deep sleep'],[],"[{'cui': 'C0443183', 'cui_str': 'Closed loop'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}]","[{'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0234451', 'cui_str': 'Non-rapid eye movement sleep'}]",,0.0164796,A proof-of-concept trial was conducted with this system and it was found that using this concept resulted in a reduction of sleep latency and latency to deep sleep.,"[{'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Garcia-Molina', 'Affiliation': ''}, {'ForeName': 'Boomika', 'Initials': 'B', 'LastName': 'Kalyan', 'Affiliation': ''}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Aquino', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/EMBC44109.2020.9175689']
3061,33018086,Sex Differences in Heart Rate Nonlinearity by Multifractal Multiscale Detrended Fluctuation Analysis.,"Recent developments of detrended fluctuation analysis (DFA) provide multifractal/multiscale (MFMS) descriptions of the heart rate self-similarity, a promising approach to cardiovascular complexity. However, it is unclear whether the MFMS DFA may also describe the nonlinear components of heart rate variability. Our aim is to define MFMS DFA indices for quantifying the short-term and long-term degree of the heart-rate nonlinearity and to apply these indices to detect possible sex-related differences.We recorded the inter-beat-interval (IBI) series in 42 male and in 42 female healthy participants sitting at rest for about 2 hours. For each series j, we generated 100 phase-randomized surrogate series. We applied the MFMS DFA to estimate the self-similarity coefficients α over scales τ between 8 and 512 s and moment orders q between -5 and +5, obtaining coefficients for the original series, α O,j  (q, τ), and for each surrogate, α i,j  (q, τ) with 1≤i≤100. We first evaluated π j (q, τ), percentile of α i,j  (q, τ) distribution in which was α O,j  (q, τ). Then we calculated the percentages of scales where π j (q, τ) was <5% for 8≤τ≤16 s (short-term nonlinearity index NL 1 (q)) and for 16≤τ≤512 s (long-term nonlinearity index NL 2 (q)). We found that NL 1 (q) was generally greater than 50% at all q≥0 but q=2 (i.e., moment order of the monofractal DFA), while at q<0 it was high in males only, with significant sex differences at q=-1 and q=-2. Results indicate that the multifractal DFA may highlight nonlinear heart-rate components at the short scales that are not revealed by the traditional monofractal DFA and that appear related to gender differences.Clinical Relevance- This supports the use of MFMS DFA to integrate the linear information from traditional spectral methods of heart rate variability in clinical studies aimed at improving the stratification of the cardiovascular risk.",2020,"Then we calculated the percentages of scales where π j (q, τ) was <5% for 8≤τ≤16 s (short-term nonlinearity index NL 1 (q)) and for 16≤τ≤512 s (long-term nonlinearity index NL 2 (q)).",['42 male and in 42 female healthy participants sitting at rest for about 2 hours'],"['Clinical Relevance', 'MFMS DFA']","['π j (q, τ), percentile of α i,j  (q, τ) distribution']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C1292425', 'cui_str': '2 hours'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0231239', 'cui_str': 'Fluctuation'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}]",42.0,0.0275659,"Then we calculated the percentages of scales where π j (q, τ) was <5% for 8≤τ≤16 s (short-term nonlinearity index NL 1 (q)) and for 16≤τ≤512 s (long-term nonlinearity index NL 2 (q)).","[{'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Castiglioni', 'Affiliation': ''}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Lazzeroni', 'Affiliation': ''}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Coruzzi', 'Affiliation': ''}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Faini', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/EMBC44109.2020.9176704']
3062,33018534,Modulatory Effects of Respiratory-Gated Auricular Vagal Nerve Stimulation on Cardiovagal Activity in Hypertension .,"The objective of this study was to determine potential effects of Respiratory-gated Auricular Vagal Afferent Nerve Stimulation (RAVANS) on cardiac autonomic activity in hypertensive patients.20 hypertensive subjects (57.3±6.2 years; 11 females, 9 males) were randomized to receive either active RAVANS at 25 Hz or sham stimulation for 5 consecutive days and were assessed 5 and 10 days later. Continuous electrocardiogram, pulse rate, and blood pressure signals were collected during 10-minute baseline, 30-minute stimulation, and 10-minute recovery periods for each session. LabChart was used to acquire and process heart rate variability and blood pressure indices. Percent changes of mean values during the recovery period were calculated comparing the final stimulation session and follow-up sessions to the first stimulation session. General linear models were applied to assess the effects of RAVANS on the variables evaluated, considering baseline values and sex as covariates in the models.We found that RAVANS increased high frequency (HF-HRV) power during recovery of the final stimulation session and both follow-up sessions in comparison to sham. RAVANS also lowered heart rate and increased average RR and root mean square of successive RR interval differences (RMSSD) during recovery on the final day of stimulation. No significant effects on blood pressure values were observed during these periods.These results suggest that RAVANS effectively stimulates cardiovagal activity in hypertension, with effects lasting up to 10 days. Future research incorporating larger sample sizes is needed to replicate the effects of RAVANS.Clinical Relevance- This research has implications for potential therapeutic effects of respiratory-gated tVNS on cardiovagal modulation in hypertensive patients.",2020,RAVANS also lowered heart rate and increased average RR and root mean square of successive RR interval differences (RMSSD) during recovery on the final day of stimulation.,"['hypertensive patients.20 hypertensive subjects (57.3±6.2 years; 11 females, 9 males', 'Hypertension ', 'hypertensive patients']","['Respiratory-gated Auricular Vagal Afferent Nerve Stimulation (RAVANS', 'Respiratory-Gated Auricular Vagal Nerve Stimulation', 'active RAVANS at 25 Hz or sham stimulation', 'respiratory-gated tVNS', 'RAVANS.Clinical Relevance']","['cardiac autonomic activity', 'heart rate and increased average RR and root mean square of successive RR interval differences (RMSSD', 'Cardiovagal Activity', 'blood pressure values', 'high frequency (HF-HRV', 'Continuous electrocardiogram, pulse rate, and blood pressure signals']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0237633', 'cui_str': 'Sensory Filtering'}, {'cui': 'C1522191', 'cui_str': 'Otic route'}, {'cui': 'C0205115', 'cui_str': 'Afferent'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0010343', 'cui_str': 'Croatia'}, {'cui': 'C0199562', 'cui_str': 'Continuous electrocardiogram'}, {'cui': 'C0232117', 'cui_str': 'Pulse rate'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}]",,0.0436104,RAVANS also lowered heart rate and increased average RR and root mean square of successive RR interval differences (RMSSD) during recovery on the final day of stimulation.,"[{'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Staley', 'Affiliation': ''}, {'ForeName': 'Ronald G', 'Initials': 'RG', 'LastName': 'Garcia', 'Affiliation': ''}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Stowell', 'Affiliation': ''}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Sclocco', 'Affiliation': ''}, {'ForeName': 'Harrison', 'Initials': 'H', 'LastName': 'Fisher', 'Affiliation': ''}, {'ForeName': 'Vitaly', 'Initials': 'V', 'LastName': 'Napadow', 'Affiliation': ''}, {'ForeName': 'Jill M', 'Initials': 'JM', 'LastName': 'Goldstein', 'Affiliation': ''}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Barbieri', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/EMBC44109.2020.9175768']
3063,33019480,Extracorporeal shockwave therapy combined with multiple drilling and intramedullary drug injection for treating early-stage Femur Head Necrosis: Protocol for a randomized controlled trial.,"BACKGROUND


Early diagnosis and treatment of the osteonecrosis of the femoral head (ONFH), a refractory disease, is imperative to prevent femoral head collapse; however, the existing solutions remain controversial. This study assessed the safety and efficacy of extracorporeal shock wave therapy (ESWT) combined with multiple drilling and intramedullary drug injection, a novel cocktail therapy, as a randomized controlled trial (RCT) model to postulate an alternative therapy for patients with early-stage ONFH.
METHODS


Femoral head necrosis patients aged 20 to 60 years with stage ARCO I-II were recruited. One hundred twenty eligible participants were randomized into four groups in a 1:1:1:1 ratio: extracorporeal shock wave therapy combined with multiple drilling and intramedullary drug injection (group EMI), extracorporeal shock wave therapy (group E), multiple drilling combined with intramedullary drug injection (group MI), and multiple drilling (""positive"" control group; group M). The primary outcomes included effective rate, subchondral collapse rate of the femoral head, lesion size, and grade of bone marrow edema. Secondary outcomes included the Harris Hip Score and the visual analog scale. All outcomes were measured at the screening visit (baseline) and at the planned time intervals during treatment and follow-up, and the efficacy was statistically analyzed according to the intention-to-treat sub-populations and per-protocol sub-populations.
OBJECTIVES


To examine the clinical efficacy of ESWT combined with multiple drilling and intramedullary drug injection to provide a safe and more effective method for treating early-stage ONFH.
TRIAL REGISTRATION NUMBER


ChiCTR1900020888; Pre-results.",2020,"The primary outcomes included effective rate, subchondral collapse rate of the femoral head, lesion size, and grade of bone marrow edema.","['patients with early-stage ONFH', 'One hundred twenty eligible participants', 'Femoral head necrosis patients aged 20 to 60 years with stage ARCO I-II were recruited']","['extracorporeal shock wave therapy (ESWT) combined with multiple drilling and intramedullary drug injection', 'Extracorporeal shockwave therapy combined with multiple drilling and intramedullary drug injection', 'extracorporeal shock wave therapy combined with multiple drilling and intramedullary drug injection (group EMI), extracorporeal shock wave therapy (group E), multiple drilling combined with intramedullary drug injection (group MI), and multiple drilling (""positive"" control group; group M', 'ESWT combined with multiple drilling and intramedullary drug injection']","['Harris Hip Score and the visual analog scale', 'effective rate, subchondral collapse rate of the femoral head, lesion size, and grade of bone marrow edema', 'safety and efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0015813', 'cui_str': 'Structure of head of femur'}, {'cui': 'C0027540', 'cui_str': 'Necrosis'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C2743413', 'cui_str': 'ARCO'}]","[{'cui': 'C1737238', 'cui_str': 'Extracorporeal shock wave therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0337279', 'cui_str': 'Drilling - action'}, {'cui': 'C1512957', 'cui_str': 'Intramedullary route'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441839', 'cui_str': 'Group E'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441847', 'cui_str': 'Group M'}]","[{'cui': 'C2919875', 'cui_str': 'Harris hip score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0015813', 'cui_str': 'Structure of head of femur'}, {'cui': 'C0449453', 'cui_str': 'Lesion size'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0948162', 'cui_str': 'Edema of bone marrow'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",120.0,0.140282,"The primary outcomes included effective rate, subchondral collapse rate of the femoral head, lesion size, and grade of bone marrow edema.","[{'ForeName': 'Qianchun', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'School of Clinical Medicine, Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Rigao', 'Initials': 'R', 'LastName': 'Chen', 'Affiliation': 'Department of Orthopedics, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': 'Department of Orthopedics, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu.'}, {'ForeName': 'Xinling', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Orthopedics, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu.'}, {'ForeName': 'Xueya', 'Initials': 'X', 'LastName': 'Feng', 'Affiliation': 'Department of Anorectal Surgery, Nanchong Central Hospital, Nanchong.'}, {'ForeName': 'Leiming', 'Initials': 'L', 'LastName': 'Jiang', 'Affiliation': 'Department of Orthopedics, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu.'}, {'ForeName': 'Botao', 'Initials': 'B', 'LastName': 'Chen', 'Affiliation': 'Department of Orthopedics, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Xin', 'Affiliation': 'Department of Intensive Care Unit, JianGe County Hospital of Traditional Chinese Medicine, Guangyuan, Sichuan, China.'}, {'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'Department of Orthopedics, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu.'}, {'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': 'Department of Orthopedics, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Jian', 'Affiliation': 'Department of Orthopedics, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu.'}, {'ForeName': 'Zhongchao', 'Initials': 'Z', 'LastName': 'Jiang', 'Affiliation': 'Department of Orthopedics, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu.'}, {'ForeName': 'Xiaohong', 'Initials': 'X', 'LastName': 'Fan', 'Affiliation': 'Department of Orthopedics, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu.'}]",Medicine,['10.1097/MD.0000000000022598']
3064,33020090,Scalable solution for delivery of diabetes self-management education in Thailand (DSME-T): a cluster randomised trial study protocol.,"INTRODUCTION


Type 2 diabetes mellitus is among the foremost health challenges facing policy makers in Thailand as its prevalence has more than tripled over the last two decades, accounting for considerable death, disability and healthcare expenditure. Diabetes self-management education (DSME) programmes show promise in improving diabetes outcomes, but this is not routinely used in Thailand. This study aims to test a culturally tailored DSME model in Thailand, using a three-arm cluster randomised controlled trial comparing a nurse-led model, a peer-assisted model and standard care. We will test which model is effective and cost effective to improve cardiovascular risk and control of blood glucose among people with diabetes.
METHODS AND ANALYSIS


21 primary care units in northern Thailand will be randomised to one of three interventions, enrolling a total of 693 patients. The primary care units will be randomised (1:1:1) to participate in a culturally-tailored DSME intervention for 12 months. The three-arm trial design will compare effectiveness of nurse-led, peer-assisted (Thai village health volunteers) and standard care. The primary trial outcomes are changes in haemoglobin A1c and cardiovascular risk score. A process evaluation and cost effectiveness evaluation will be conducted to produce policy relevant guidance for the Thai Ministry of Public Health. The planned trial period will start in January 2020 and finish October 2021.
ETHICS AND DISSEMINATION


Ethical approval has been obtained from Thailand and the UK. We will share our study data with other researchers, advertising via our publications and web presence. In particular, we are committed to sharing our findings and data with academic audiences in Thailand and other low-income and middle-income countries.
TRIAL REGISTRATION NUMBER


NCT03938233.",2020,"We will test which model is effective and cost effective to improve cardiovascular risk and control of blood glucose among people with diabetes.
","['21 primary care units in northern Thailand will be randomised to one of three interventions, enrolling a total of 693 patients', 'people with diabetes']","['culturally-tailored DSME intervention', 'nurse-led model, a peer-assisted model and standard care', 'nurse-led, peer-assisted (Thai village health volunteers) and standard care']","['changes in haemoglobin A1c and cardiovascular risk score', 'cardiovascular risk and control of blood glucose']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0039725', 'cui_str': 'Thailand'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C1319140', 'cui_str': 'Diabetes self-management behavior'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039724', 'cui_str': 'Thai language'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}]",693.0,0.11453,"We will test which model is effective and cost effective to improve cardiovascular risk and control of blood glucose among people with diabetes.
","[{'ForeName': 'Chaisiri', 'Initials': 'C', 'LastName': 'Angkurawaranon', 'Affiliation': 'Department of Family Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand chaisiri.a@cmu.ac.th.'}, {'ForeName': 'Iliatha', 'Initials': 'I', 'LastName': 'Papachristou Nadal', 'Affiliation': 'Department of Non-Communicable Disease Epidemiology, Faculty of Epidemiology and Population Health,London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Poppy Alice Carson', 'Initials': 'PAC', 'LastName': 'Mallinson', 'Affiliation': 'Department of Non-Communicable Disease Epidemiology, Faculty of Epidemiology and Population Health,London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Kanokporn', 'Initials': 'K', 'LastName': 'Pinyopornpanish', 'Affiliation': 'Department of Family Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Orawan', 'Initials': 'O', 'LastName': 'Quansri', 'Affiliation': 'ASEAN Institute for Health Development, Mahidol University, Salaya, Thailand.'}, {'ForeName': 'Kittipan', 'Initials': 'K', 'LastName': 'Rerkasem', 'Affiliation': 'Department of Surgery, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Supattra', 'Initials': 'S', 'LastName': 'Srivanichakorn', 'Affiliation': 'Royal Thai Government Ministry of Public Health, Bangkok, Thailand.'}, {'ForeName': 'Win', 'Initials': 'W', 'LastName': 'Techakehakij', 'Affiliation': 'Lampang Hospital, Lampang, Thailand.'}, {'ForeName': 'Nutchanath', 'Initials': 'N', 'LastName': 'Wichit', 'Affiliation': 'Surat Thani Rajabhat University, Surat Thani, Thailand.'}, {'ForeName': 'Chanapat', 'Initials': 'C', 'LastName': 'Pateekhum', 'Affiliation': 'Department of Family Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Ahmar H', 'Initials': 'AH', 'LastName': 'Hashmi', 'Affiliation': 'Department of Family Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Kara', 'Initials': 'K', 'LastName': 'Hanson', 'Affiliation': 'Department of Global Health and Development, Faculty of Public Health of Public Health and Policy, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Kamlesh', 'Initials': 'K', 'LastName': 'Khunti', 'Affiliation': 'Department of Health Sciences, University of Leicester, Leicester, UK.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Kinra', 'Affiliation': 'Department of Non-Communicable Disease Epidemiology, Faculty of Epidemiology and Population Health,London School of Hygiene and Tropical Medicine, London, UK.'}]",BMJ open,['10.1136/bmjopen-2020-036963']
3065,33017428,Mortality rate-dependent variations in antenatal corticosteroid-associated outcomes in very low birth weight infants with 23-34 weeks of gestation: A nationwide cohort study.,"Antenatal corticosteroid (ACS) administration has been known as one of the most effective treatment in perinatal medicine, but the beneficial effects of ACS may vary not only gestational age, but also the quality of perinatal and neonatal care of the institution. This nationwide cohort study of the Korean Neonatal Network (KNN) data was consisted of <1,500g infants born at 23-34 weeks at 67 KNN hospitals between 2013 and 2017. The 9,142 eligible infants were assigned into two groups-group 1 and 2 <50% and ≥50% mortality rate, respectively, for 23-24 weeks' gestation-reflecting the quality of perinatal and neonatal care. Each group of infants were further stratified into 23-24, 25-26, 27-28, and 29-34 weeks of gestation age. Despite comparable ACS usage between group 1 (82%) and group 2 (81%), the benefits of ACS were only observed in group 1. In the multivariable analyses, infants of group 1 showed significant decrease in mortality and IVH at gestational age 23-24 weeks with ACS use, and the decrease was also seen in early-onset sepsis and respiratory distress syndrome at gestational age of 29-34 weeks while there were no significant decrease in group 2. In this study the overall data was congruent with the previous findings stating that ACS use decreases mortality and morbidity. These results indicate that the improved mortality of infants at 23-24 weeks' gestation reflects the quality improvement of perinatal and neonatal intensive care, which is a prerequisite to the benefits of ACS.",2020,"In the multivariable analyses, infants of group 1 showed significant decrease in mortality and IVH at gestational age 23-24 weeks with ACS use, and the decrease was also seen in early-onset sepsis and respiratory distress syndrome at gestational age of 29-34 weeks while there were no significant decrease in group 2.","['9,142 eligible infants', 'Korean Neonatal Network (KNN) data was consisted of <1,500g infants born at 23-34 weeks at 67 KNN hospitals between 2013 and 2017', 'very low birth weight infants with 23-34 weeks of gestation']",['Antenatal corticosteroid (ACS'],"['Mortality rate', 'benefits of ACS', 'early-onset sepsis and respiratory distress syndrome', 'mortality and IVH', 'mortality and morbidity']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0282667', 'cui_str': 'Very low birth weight infant'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0035220', 'cui_str': 'Respiratory distress syndrome in the newborn'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",9142.0,0.0542073,"In the multivariable analyses, infants of group 1 showed significant decrease in mortality and IVH at gestational age 23-24 weeks with ACS use, and the decrease was also seen in early-onset sepsis and respiratory distress syndrome at gestational age of 29-34 weeks while there were no significant decrease in group 2.","[{'ForeName': 'Jin Kyu', 'Initials': 'JK', 'LastName': 'Kim', 'Affiliation': 'Department of Pediatrics, Jeonbuk National University School of Medicine, Jeonju, Korea.'}, {'ForeName': 'Jong Hee', 'Initials': 'JH', 'LastName': 'Hwang', 'Affiliation': 'Department of Pediatrics, Ilsan Paik Hospital, InJe University College of Medicine, Goyang, Korea.'}, {'ForeName': 'Myung Hee', 'Initials': 'MH', 'LastName': 'Lee', 'Affiliation': 'Statistic and Data Center, Samsung Medical Center, Seoul, Korea.'}, {'ForeName': 'Yun Sil', 'Initials': 'YS', 'LastName': 'Chang', 'Affiliation': 'Department of Pediatrics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Won Soon', 'Initials': 'WS', 'LastName': 'Park', 'Affiliation': 'Department of Pediatrics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}]",PloS one,['10.1371/journal.pone.0240168']
3066,33017434,Whole-body protein kinetics in critically ill patients during 50 or 100% energy provision by enteral nutrition: A randomized cross-over study.,"BACKGROUND


Enteral nutrition (EN) is a ubiquitous intervention in ICU patients but there is uncertainty regarding the optimal dose, timing and importance for patient-centered outcomes during critical illness. Our research group has previously found an improved protein balance during normocaloric versus hypocaloric parenteral nutrition in neurosurgical ICU patients. We now wanted to investigate if this could be demonstrated in a general ICU population with established enteral feeding, including patients on renal replacement therapy.
METHODS


Patients with EN >80% of energy target as determined by indirect calorimetry were randomized to or 50% or 100% of current EN rate. After 24 hours, whole-body protein kinetics were determined by enteral and parenteral stable isotope tracer infusions. Treatment allocation was then switched, and tracer investigations repeated 24 hours later in a crossover design with patients serving as their own controls.
RESULTS


Six patients completed the full protocol. During feeding with 100% EN all patients received >1.2 g/kg/day of protein. Mean whole-body protein balance increased from -6.07 to 2.93 µmol phenylalanine/kg/h during 100% EN as compared to 50% (p = 0.044). The oxidation rate of phenylalanine was unaltered (p = 0.78).
CONCLUSIONS


It is possible to assess whole-body protein turnover using a stable isotope technique in critically ill patients during enteral feeding and renal replacement therapy. Our results also suggest a better whole-body protein balance during full dose as compared to half dose EN. As the sample size was smaller than anticipated, this finding should be confirmed in larger studies.",2020,Mean whole-body protein balance increased from -6.07 to 2.93 µmol phenylalanine/kg/h during 100% EN as compared to 50% (p = 0.044).,"['neurosurgical ICU patients', 'ICU patients', 'Patients with EN >80% of energy target as determined by indirect calorimetry', 'general ICU population with established enteral feeding, including patients on renal replacement therapy', 'critically ill patients during enteral feeding and renal replacement therapy', 'critically ill patients during 50 or 100% energy provision by enteral nutrition']",['Enteral nutrition (EN'],"['Mean whole-body protein balance', 'protein balance', 'oxidation rate of phenylalanine']","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0014327', 'cui_str': 'Enteral nutrition'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0006781', 'cui_str': 'Indirect calorimetry'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0086225', 'cui_str': 'Enteral feeding'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0014327', 'cui_str': 'Enteral nutrition'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0031453', 'cui_str': 'Phenylalanine'}]",,0.0217836,Mean whole-body protein balance increased from -6.07 to 2.93 µmol phenylalanine/kg/h during 100% EN as compared to 50% (p = 0.044).,"[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Sundström Rehal', 'Affiliation': 'Department of Perioperative Medicine and Intensive Care (PMI), Karolinska University Hospital Huddinge, Stockholm, Sweden.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Liebau', 'Affiliation': 'Department of Perioperative Medicine and Intensive Care (PMI), Karolinska University Hospital Huddinge, Stockholm, Sweden.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Wernerman', 'Affiliation': 'Division of Anesthesia and Intensive Care, Department of Clinical Science, Intervention and Technology (CLINTEC), Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Olav', 'Initials': 'O', 'LastName': 'Rooyackers', 'Affiliation': 'Department of Perioperative Medicine and Intensive Care (PMI), Karolinska University Hospital Huddinge, Stockholm, Sweden.'}]",PloS one,['10.1371/journal.pone.0240045']
3067,33017450,Origami folding: Taxing resources necessary for the acquisition of sequential skills.,"Sequential skill learning with practice is fundamental to human activity (e.g., tying shoes). Given the lack of prior knowledge in most participants, Origami folding is a promising task to study the acquisition of a sequential skill. While previous Origami folding studies mainly dealt with the question, which forms of instruction can lead to better learning outcomes, we employ a dual-task approach to test which resources are necessary for folding and for improvement with practice. Participants (N = 53) folded five Origami figures for four times each, which were randomly paired with five types of secondary tasks to cause either cognitive (verbal vs. visuospatial) or motoric (isochronous vs. non-isochronous tapping) memory load or none (control condition). Origami performance showed a typical learning curve from Trial 1 (first run of folding the figure) to Trial 4 (fourth run of folding the same figure). We tested for a dissociation between variants of memory load influencing Origami folding performance vs. the variants influencing learning (i.e. change in performance across practice). In line with theories suggesting that learning operates on the level that (at a given point in practice) demands the most control, we did not observe cases where a dual-task variant influenced performance while it did not affect learning. Memory load from the cognitive visuospatial secondary task as well as the isochronous tapping secondary task interfered with improvement in Origami folding with practice. This might be due to the use of visuospatial sketchpad and absolute timing mechanism during the acquisition of Origami folding.",2020,Memory load from the cognitive visuospatial secondary task as well as the isochronous tapping secondary task interfered with improvement in Origami folding with practice.,[],['secondary tasks to cause either cognitive (verbal vs. visuospatial) or motoric (isochronous vs. non-isochronous tapping) memory load or none (control condition'],['Origami performance'],[],"[{'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",[],53.0,0.0243564,Memory load from the cognitive visuospatial secondary task as well as the isochronous tapping secondary task interfered with improvement in Origami folding with practice.,"[{'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Zhao', 'Affiliation': 'Department of Psychology, University of Hagen, Hagen, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Gaschler', 'Affiliation': 'Department of Psychology, University of Hagen, Hagen, Germany.'}, {'ForeName': 'Anneli', 'Initials': 'A', 'LastName': 'Kneschke', 'Affiliation': 'Department of Psychology, University of Hagen, Hagen, Germany.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Radler', 'Affiliation': 'Department of Psychology, University of Hagen, Hagen, Germany.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Gausmann', 'Affiliation': 'Department of Psychology, University of Hagen, Hagen, Germany.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Duttine', 'Affiliation': 'Department of Psychology, University of Hagen, Hagen, Germany.'}, {'ForeName': 'Hilde', 'Initials': 'H', 'LastName': 'Haider', 'Affiliation': 'Department of Psychology, University of Cologne, Cologne, Germany.'}]",PloS one,['10.1371/journal.pone.0240226']
3068,32994242,Strategies to Promote ResiliencY (SPRY): a randomised embedded multifactorial adaptative platform (REMAP) clinical trial protocol to study interventions to improve recovery after surgery in high-risk patients.,"INTRODUCTION


As the population ages, there is interest in strategies to promote resiliency, especially for frail patients at risk of its complications. The physiological stress of surgery in high-risk individuals has been proposed both as an important cause of accelerated age-related decline in health and as a model testing the effectiveness of strategies to improve resiliency to age-related health decline. We describe a randomised, embedded, multifactorial, adaptative platform (REMAP) trial to investigate multiple perioperative interventions, the first of which is metformin and selected for its anti-inflammatory and anti-ageing properties beyond its traditional blood glucose control features.
METHODS AND ANALYSIS


Within a multihospital, single healthcare system, the Core Protocol for Strategies to Promote ResiliencY (SPRY) will be embedded within both the electronic health record (EHR) and the healthcare culture generating a continuously self-learning healthcare system. Embedding reduces the administrative burden of a traditional trial while accessing and rapidly analysing routine patient care EHR data. SPRY-Metformin is a placebo-controlled trial and is the first SPRY domain evaluating the effectiveness of three metformin dosages across three preoperative durations within a heterogeneous set of major surgical procedures. The primary outcome is 90-day hospital-free days. Bayesian posterior probabilities guide interim decision-making with predefined rules to determine stopping for futility or superior dosing selection. Using response adaptative randomisation, a maximum of 2500 patients allows 77%-92% power, detecting >15% primary outcome improvement. Secondary outcomes include mortality, readmission and postoperative complications. A subset of patients will be selected for substudies evaluating the microbiome, cognition, postoperative delirium and strength.
ETHICS AND DISSEMINATION


The Core Protocol of SPRY REMAP and associated SPRY-Metformin Domain-Specific Appendix have been ethically approved by the Institutional Review Board and are publicly registered. Results will be publicly available to healthcare providers, patients and trial participants following achieving predetermined platform conclusions.
TRIAL REGISTRATION NUMBER


NCT03861767.",2020,Bayesian posterior probabilities guide interim decision-making with predefined rules to determine stopping for futility or superior dosing selection.,"['frail patients at risk of its complications', 'high-risk patients']","['Metformin', 'SPRY']","['mortality, readmission and postoperative complications', '90-day hospital-free days']","[{'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0587438', 'cui_str': 'Day hospital'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",2500.0,0.142159,Bayesian posterior probabilities guide interim decision-making with predefined rules to determine stopping for futility or superior dosing selection.,"[{'ForeName': 'Katherine Moll', 'Initials': 'KM', 'LastName': 'Reitz', 'Affiliation': 'Department of Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania, USA reitzkm2@upmc.edu.'}, {'ForeName': 'Christopher W', 'Initials': 'CW', 'LastName': 'Seymour', 'Affiliation': 'Department of Critical Care Medicine, UPMC, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Vates', 'Affiliation': 'Department of Critical Care Medicine, UPMC, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Quintana', 'Affiliation': 'Berry Consultants Statistical Innovation, Austin, Texas, USA.'}, {'ForeName': 'Kert', 'Initials': 'K', 'LastName': 'Viele', 'Affiliation': 'Berry Consultants Statistical Innovation, Austin, Texas, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Detry', 'Affiliation': 'Berry Consultants Statistical Innovation, Austin, Texas, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Morowitz', 'Affiliation': ""Department of Surgery, Children's Hospital of Pittsburgh of UPMC, Pittsburgh, Pennsylvania, USA.""}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Morris', 'Affiliation': 'Department of Medicine, UPMC, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Methe', 'Affiliation': 'Department of Medicine, UPMC, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Kennedy', 'Affiliation': 'Department of Critical Care Medicine, UPMC, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Zuckerbraun', 'Affiliation': 'Department of Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Timothy D', 'Initials': 'TD', 'LastName': 'Girard', 'Affiliation': 'Department of Critical Care Medicine, UPMC, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Oscar C', 'Initials': 'OC', 'LastName': 'Marroquin', 'Affiliation': 'Clinical Analytics, UPMC Health System, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Esper', 'Affiliation': 'Anesthesiology, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Holder-Murray', 'Affiliation': 'Department of Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Anne B', 'Initials': 'AB', 'LastName': 'Newman', 'Affiliation': 'Department of Epidemiology, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Berry', 'Affiliation': 'Berry Consultants Statistical Innovation, Austin, Texas, USA.'}, {'ForeName': 'Derek C', 'Initials': 'DC', 'LastName': 'Angus', 'Affiliation': 'Department of Critical Care Medicine, UPMC, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Neal', 'Affiliation': 'Department of Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}]",BMJ open,['10.1136/bmjopen-2020-037690']
3069,32994251,Evaluation of the efficacy of low concentration fluoride gel using custom trays to prevent radiation-related dental caries in patients with head and neck cancer: protocol for a randomised controlled phase III trial (FluCar study).,"INTRODUCTION


The present study is a randomised, multicentre, open-label, phase III study, to evaluate the efficacy of low concentration of fluoride gel, applied using custom trays, in preventing radiation-related dental caries in patients with head and neck cancer who have undergone or are undergoing radiotherapy.
METHODS AND ANALYSIS


Patients will be randomised into fluoride and control groups (1:1 ratio). In the fluoride group, patients will wear custom trays loaded with 0.145% fluoride gel after brushing every night while sleeping. In the control group, patients will receive oral hygiene instructions as usual. Patients in both the groups will be followed up every 3 months for 1 year. The primary endpoint is the incidence of newly developed dental caries. Target accrual is 80 patients with a two-sided type I error rate of 5% and 80% power to detect 80% risk reduction.
ETHICS AND DISSEMINATION


This study was approved by the Clinical Research Review Board in Nagasaki University The protocol of this study was registered at Japan Registry of Clinical Trials (jRCT) and University hospital Medical Information Network Clinical Trials Registry (UMIN). The datasets generated during the current study will be available from the corresponding author on reasonable request. TRIAL REGISTRATION NUMBERS: jRCTs 072190039 and UMIN000041426.",2020,"The present study is a randomised, multicentre, open-label, phase III study, to evaluate the efficacy of low concentration of fluoride gel, applied using custom trays, in preventing radiation-related dental caries in patients with head and neck cancer who have undergone or are undergoing radiotherapy.
","['patients with head and neck cancer', 'Nagasaki University', '80 patients with a two-sided type I error rate of 5% and 80% power to detect 80% risk reduction', 'patients with head and neck cancer who have undergone or are undergoing radiotherapy']","['fluoride gel', 'fluoride', 'low concentration fluoride gel', 'fluoride gel, applied using custom trays']",['incidence of newly developed dental caries'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0205557', 'cui_str': 'False positive'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C3881208', 'cui_str': 'Fluoride gel'}, {'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0162343', 'cui_str': 'Customs'}, {'cui': 'C0184054', 'cui_str': 'Tray'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}]",,0.100873,"The present study is a randomised, multicentre, open-label, phase III study, to evaluate the efficacy of low concentration of fluoride gel, applied using custom trays, in preventing radiation-related dental caries in patients with head and neck cancer who have undergone or are undergoing radiotherapy.
","[{'ForeName': 'Soutome', 'Initials': 'S', 'LastName': 'Sakiko', 'Affiliation': 'Department of Oral Health, Nagasaki University, Nagasaki, Japan.'}, {'ForeName': 'Souichi', 'Initials': 'S', 'LastName': 'Yanamoto', 'Affiliation': 'Department of Clinical Oral Oncology, Nagasaki University, Nagasaki, Japan syana@nagasaki-u.ac.jp.'}, {'ForeName': 'Maho', 'Initials': 'M', 'LastName': 'Murata', 'Affiliation': 'Department of Clinical Oral Oncology, Nagasaki University, Nagasaki, Japan.'}, {'ForeName': 'Yumiko', 'Initials': 'Y', 'LastName': 'Kawashita', 'Affiliation': 'Department of Oral Health, Nagasaki University, Nagasaki, Japan.'}, {'ForeName': 'Masako', 'Initials': 'M', 'LastName': 'Yoshimatsu', 'Affiliation': 'Oral Care Center, Nagasaki Daigaku Byoin, Nagasaki, Japan.'}, {'ForeName': 'Madoka', 'Initials': 'M', 'LastName': 'Funahara', 'Affiliation': 'School of Oral Health, Kyushu Shika Daigaku, Kitakyushu, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Umeda', 'Affiliation': 'Department of Clinical Oral Oncology, Nagasaki University, Nagasaki, Japan.'}, {'ForeName': 'Toshiyuki', 'Initials': 'T', 'LastName': 'Saito', 'Affiliation': 'Department of Oral Health, Nagasaki University, Nagasaki, Japan.'}]",BMJ open,['10.1136/bmjopen-2020-038606']
3070,33001135,Efficacy and Safety of Nivolumab Plus Ipilimumab in Patients With Advanced Hepatocellular Carcinoma Previously Treated With Sorafenib: The CheckMate 040 Randomized Clinical Trial.,"Importance


Most patients with hepatocellular carcinoma (HCC) are diagnosed with advanced disease not eligible for potentially curative therapies; therefore, new treatment options are needed. Combining nivolumab with ipilimumab may improve clinical outcomes compared with nivolumab monotherapy.
Objective


To assess efficacy and safety of nivolumab plus ipilimumab in patients with advanced HCC who were previously treated with sorafenib.
Design, Setting, and Participants


CheckMate 040 is a multicenter, open-label, multicohort, phase 1/2 study. In the nivolumab plus ipilimumab cohort, patients were randomized between January 4 and September 26, 2016. Treatment group information was blinded after randomization. Median follow-up was 30.7 months. Data cutoff for this analysis was January 2019. Patients were recruited at 31 centers in 10 countries/territories in Asia, Europe, and North America. Eligible patients had advanced HCC (with/without hepatitis B or C) previously treated with sorafenib. A total of 148 patients were randomized (50 to arm A and 49 each to arms B and C).
Interventions


Patients were randomized 1:1:1 to either nivolumab 1 mg/kg plus ipilimumab 3 mg/kg, administered every 3 weeks (4 doses), followed by nivolumab 240 mg every 2 weeks (arm A); nivolumab 3 mg/kg plus ipilimumab 1 mg/kg, administered every 3 weeks (4 doses), followed by nivolumab 240 mg every 2 weeks (arm B); or nivolumab 3 mg/kg every 2 weeks plus ipilimumab 1 mg/kg every 6 weeks (arm C).
Main Outcomes and Measures


Coprimary end points were safety, tolerability, and objective response rate. Duration of response was also measured (investigator assessed with the Response Evaluation Criteria in Solid Tumors v1.1).
Results


Of 148 total participants, 120 were male (81%). Median (IQR) age was 60 (52.5-66.5). At data cutoff (January 2019), the median follow-up was 30.7 months (IQR, 29.9-34.7). Investigator-assessed objective response rate was 32% (95% CI, 20%-47%) in arm A, 27% (95% CI, 15%-41%) in arm B, and 29% (95% CI, 17%-43%) in arm C. Median (range) duration of response was not reached (8.3-33.7+) in arm A and was 15.2 months (4.2-29.9+) in arm B and 21.7 months (2.8-32.7+) in arm C. Any-grade treatment-related adverse events were reported in 46 of 49 patients (94%) in arm A, 35 of 49 patients (71%) in arm B, and 38 of 48 patients (79%) in arm C; there was 1 treatment-related death (arm A; grade 5 pneumonitis).
Conclusions and Relevance


In this randomized clinical trial, nivolumab plus ipilimumab had manageable safety, promising objective response rate, and durable responses. The arm A regimen (4 doses nivolumab 1 mg/kg plus ipilimumab 3 mg/kg every 3 weeks then nivolumab 240 mg every 2 weeks) received accelerated approval in the US based on the results of this study.
Trial Registration


ClinicalTrials.gov Identifier: NCT01658878.",2020,"Investigator-assessed objective response rate was 32% (95% CI, 20%-47%) in arm A, 27% (95% CI, 15%-41%) in arm B, and 29% (95% CI, 17%-43%) in arm C. Median (range)","['Patients were recruited at 31 centers in 10 countries/territories in Asia, Europe, and North America', '148 total participants, 120 were male (81', 'patients with advanced HCC who were previously treated with sorafenib', 'Eligible patients had advanced HCC (with/without hepatitis B or C) previously treated with', 'patients with hepatocellular carcinoma (HCC', 'Patients With Advanced Hepatocellular Carcinoma', '148 patients']","['nivolumab 3 mg/kg plus ipilimumab', 'Nivolumab Plus Ipilimumab', 'nivolumab 1 mg/kg plus ipilimumab', 'Sorafenib', 'ipilimumab', 'nivolumab 3 mg/kg every 2 weeks plus ipilimumab', 'sorafenib', 'nivolumab plus ipilimumab']","['Duration of response', 'efficacy and safety', 'safety, tolerability, and objective response rate', 'Efficacy and Safety', 'adverse events', 'duration of response', 'objective response rate, and durable responses', 'Investigator-assessed objective response rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0019163', 'cui_str': 'Type B viral hepatitis'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}]",148.0,0.400256,"Investigator-assessed objective response rate was 32% (95% CI, 20%-47%) in arm A, 27% (95% CI, 15%-41%) in arm B, and 29% (95% CI, 17%-43%) in arm C. Median (range)","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Yau', 'Affiliation': 'Department of Medicine, University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Yoon-Koo', 'Initials': 'YK', 'LastName': 'Kang', 'Affiliation': 'Asan Medical Center, Department of Oncology, University of Ulsan, Seoul, South Korea.'}, {'ForeName': 'Tae-You', 'Initials': 'TY', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Seoul National University, Seoul, South Korea.'}, {'ForeName': 'Anthony B', 'Initials': 'AB', 'LastName': 'El-Khoueiry', 'Affiliation': 'Norris Comprehensive Cancer Center, Division of Medical Oncology/Hematology, University of Southern California, Los Angeles, California.'}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'Santoro', 'Affiliation': 'Humanitas Clinical and Research Center, Department of Medical Oncology, Humanitas University, Rozzano, Italy.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Sangro', 'Affiliation': 'Department of Internal Medicine, Clinica Universidad de Navarra, Instituto de Investigación Sanitaria de Navarra, and Centro de Investigacion Biomedica en Red de Enfermedades Hepaticas y Digestivas, Pamplona, Spain.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Melero', 'Affiliation': 'Department of Immunology and Immunotherapy, Clinica Universidad de Navarra and Centro de Investigación Biomédica en Red de Cáncer, Pamplona, Spain.'}, {'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Kudo', 'Affiliation': 'Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka, Japan.'}, {'ForeName': 'Ming-Mo', 'Initials': 'MM', 'LastName': 'Hou', 'Affiliation': 'Division of Hematology-Oncology, Department of Internal Medicine, Chang Gung Memorial Hospital, Taipei, Taiwan.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Matilla', 'Affiliation': 'Department of Medicine, Servicio de Digestivo, Hospital General Universitario Gregorio Marañón, Centro de Investigacion Biomedica en Red de Enfermedades Hepaticas y Digestivas, Madrid, Spain.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Tovoli', 'Affiliation': 'Department of Medical & Surgical Sciences, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Jennifer J', 'Initials': 'JJ', 'LastName': 'Knox', 'Affiliation': 'Cancer Clinical Research Unit, Princess Margaret Cancer Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Aiwu', 'Initials': 'A', 'LastName': 'Ruth He', 'Affiliation': 'Division of Hematology/Oncology, Lombardi Comprehensive Cancer Center, Georgetown University Medical Center, Washington, DC.'}, {'ForeName': 'Bassel F', 'Initials': 'BF', 'LastName': 'El-Rayes', 'Affiliation': 'Department of Hematology, Emory University Winship Cancer Institute, Atlanta, Georgia.'}, {'ForeName': 'Mirelis', 'Initials': 'M', 'LastName': 'Acosta-Rivera', 'Affiliation': 'Department of Hematology and Oncology, Fundacion de Investigacion, San Juan, Puerto Rico.'}, {'ForeName': 'Ho-Yeong', 'Initials': 'HY', 'LastName': 'Lim', 'Affiliation': 'Samsung Medical Center, Department of Hematology and Oncology, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Jaclyn', 'Initials': 'J', 'LastName': 'Neely', 'Affiliation': 'Department of Immuno-Oncology, Biomarkers, and Translational Medicine, Bristol Myers Squibb, Princeton, New Jersey.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Shen', 'Affiliation': 'Department of Immuno-Oncology, Oncology, and Immunology, Bristol Myers Squibb, Princeton, New Jersey.'}, {'ForeName': 'Tami', 'Initials': 'T', 'LastName': 'Wisniewski', 'Affiliation': 'Department of Clinical Research, Bristol Myers Squibb, Princeton, New Jersey.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Anderson', 'Affiliation': 'Department of Clinical Research, Bristol Myers Squibb, Princeton, New Jersey.'}, {'ForeName': 'Chiun', 'Initials': 'C', 'LastName': 'Hsu', 'Affiliation': 'Department of Oncology, National Taiwan University Hospital, Taipei, Taiwan.'}]",JAMA oncology,['10.1001/jamaoncol.2020.4564']
3071,33001138,Efficacy and Safety of Hydroxychloroquine vs Placebo for Pre-exposure SARS-CoV-2 Prophylaxis Among Health Care Workers: A Randomized Clinical Trial.,"Importance


Health care workers (HCWs) caring for patients with coronavirus disease 2019 (COVID-19) are at risk of exposure to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Currently, to our knowledge, there is no effective pharmacologic prophylaxis for individuals at risk.
Objective


To evaluate the efficacy of hydroxychloroquine to prevent transmission of SARS-CoV-2 in hospital-based HCWs with exposure to patients with COVID-19 using a pre-exposure prophylaxis strategy.
Design, Setting, and Participants


This randomized, double-blind, placebo-controlled clinical trial (the Prevention and Treatment of COVID-19 With Hydroxychloroquine Study) was conducted at 2 tertiary urban hospitals, with enrollment from April 9, 2020, to July 14, 2020; follow-up ended August 4, 2020. The trial randomized 132 full-time, hospital-based HCWs (physicians, nurses, certified nursing assistants, emergency technicians, and respiratory therapists), of whom 125 were initially asymptomatic and had negative results for SARS-CoV-2 by nasopharyngeal swab. The trial was terminated early for futility before reaching a planned enrollment of 200 participants.
Interventions


Hydroxychloroquine, 600 mg, daily, or size-matched placebo taken orally for 8 weeks.
Main Outcomes and Measures


The primary outcome was the incidence of SARS-CoV-2 infection as determined by a nasopharyngeal swab during the 8 weeks of treatment. Secondary outcomes included adverse effects, treatment discontinuation, presence of SARS-CoV-2 antibodies, frequency of QTc prolongation, and clinical outcomes for SARS-CoV-2-positive participants.
Results


Of the 132 randomized participants (median age, 33 years [range, 20-66 years]; 91 women [69%]), 125 (94.7%) were evaluable for the primary outcome. There was no significant difference in infection rates in participants randomized to receive hydroxychloroquine compared with placebo (4 of 64 [6.3%] vs 4 of 61 [6.6%]; P > .99). Mild adverse events were more common in participants taking hydroxychloroquine compared with placebo (45% vs 26%; P = .04); rates of treatment discontinuation were similar in both arms (19% vs 16%; P = .81). The median change in QTc (baseline to 4-week evaluation) did not differ between arms (hydroxychloroquine: 4 milliseconds; 95% CI, -9 to 17; vs placebo: 3 milliseconds; 95% CI, -5 to 11; P = .98). Of the 8 participants with positive results for SARS-CoV-2 (6.4%), 6 developed viral symptoms; none required hospitalization, and all clinically recovered.
Conclusions and Relevance


In this randomized clinical trial, although limited by early termination, there was no clinical benefit of hydroxychloroquine administered daily for 8 weeks as pre-exposure prophylaxis in hospital-based HCWs exposed to patients with COVID-19.
Trial Registration


ClinicalTrials.gov Identifier: NCT04329923.",2020,There was no significant difference in infection rates in participants randomized to receive hydroxychloroquine compared with placebo (4 of 64 [6.3%] vs 4 of 61 [6.6%]; P > .99).,"['Pre-exposure SARS-CoV-2 Prophylaxis', 'patients with coronavirus disease 2019 (COVID-19', '132 full-time, hospital-based HCWs (physicians, nurses, certified nursing assistants, emergency technicians, and respiratory therapists), of whom 125 were initially asymptomatic and had negative results for SARS-CoV-2 by nasopharyngeal swab', '132 randomized participants (median age, 33 years [range, 20-66 years', '2 tertiary urban hospitals, with enrollment from April 9, 2020, to July 14, 2020; follow-up ended August 4, 2020', 'hospital-based HCWs exposed to patients with COVID-19', 'hospital-based HCWs with exposure to patients with COVID-19 using a pre-exposure prophylaxis strategy', 'Health Care Workers', '200 participants']","['hydroxychloroquine', 'placebo', 'Hydroxychloroquine vs Placebo', 'COVID-19 With Hydroxychloroquine', 'Hydroxychloroquine, 600 mg, daily, or size-matched placebo']","['rates of treatment discontinuation', 'Mild adverse events', 'Efficacy and Safety', 'incidence of SARS-CoV-2 infection', 'viral symptoms; none required hospitalization', 'adverse effects, treatment discontinuation, presence of SARS-CoV-2 antibodies, frequency of QTc prolongation, and clinical outcomes for SARS-CoV-2-positive participants', 'median change in QTc', 'infection rates']","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0682295', 'cui_str': 'Full-time employment'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0007836', 'cui_str': 'Certification'}, {'cui': 'C0028663', 'cui_str': 'Nursing aid'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C1709924', 'cui_str': 'Respiratory therapist'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C4704700', 'cui_str': 'Null Results'}, {'cui': 'C0444192', 'cui_str': 'Nasopharyngeal swab'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0020029', 'cui_str': 'Urban Hospitals'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0855333', 'cui_str': 'Electrocardiogram QT corrected interval prolonged'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0860814', 'cui_str': 'QTc'}]",132.0,0.688433,There was no significant difference in infection rates in participants randomized to receive hydroxychloroquine compared with placebo (4 of 64 [6.3%] vs 4 of 61 [6.6%]; P > .99).,"[{'ForeName': 'Benjamin S', 'Initials': 'BS', 'LastName': 'Abella', 'Affiliation': 'Department of Emergency Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Eliana L', 'Initials': 'EL', 'LastName': 'Jolkovsky', 'Affiliation': 'Department of Emergency Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Barbara T', 'Initials': 'BT', 'LastName': 'Biney', 'Affiliation': 'Department of Emergency Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Julie E', 'Initials': 'JE', 'LastName': 'Uspal', 'Affiliation': 'Department of Emergency Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Matthew C', 'Initials': 'MC', 'LastName': 'Hyman', 'Affiliation': 'Division of Cardiology, Department of Medicine University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Frank', 'Affiliation': 'Division of Infectious Disease, Department of Medicine University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Scott E', 'Initials': 'SE', 'LastName': 'Hensley', 'Affiliation': 'Department of Microbiology, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Saar', 'Initials': 'S', 'LastName': 'Gill', 'Affiliation': 'Abramson Cancer Center and Division of Hematology-Oncology, Department of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Dan T', 'Initials': 'DT', 'LastName': 'Vogl', 'Affiliation': 'Abramson Cancer Center and Division of Hematology-Oncology, Department of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Maillard', 'Affiliation': 'Abramson Cancer Center and Division of Hematology-Oncology, Department of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Daria V', 'Initials': 'DV', 'LastName': 'Babushok', 'Affiliation': 'Abramson Cancer Center and Division of Hematology-Oncology, Department of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Alexander C', 'Initials': 'AC', 'LastName': 'Huang', 'Affiliation': 'Abramson Cancer Center and Division of Hematology-Oncology, Department of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Sunita D', 'Initials': 'SD', 'LastName': 'Nasta', 'Affiliation': 'Abramson Cancer Center and Division of Hematology-Oncology, Department of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Jennifer C', 'Initials': 'JC', 'LastName': 'Walsh', 'Affiliation': 'Abramson Cancer Center and Division of Hematology-Oncology, Department of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'E Paul', 'Initials': 'EP', 'LastName': 'Wiletyo', 'Affiliation': 'Department of Biostatistics, Epidemiology and Informatics, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Phyllis A', 'Initials': 'PA', 'LastName': 'Gimotty', 'Affiliation': 'Department of Biostatistics, Epidemiology and Informatics, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Milone', 'Affiliation': 'Department of Pathology, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Ravi K', 'Initials': 'RK', 'LastName': 'Amaravadi', 'Affiliation': 'Abramson Cancer Center and Division of Hematology-Oncology, Department of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA internal medicine,['10.1001/jamainternmed.2020.6319']
3072,33001140,Efficacy and Safety of Baricitinib Combined With Topical Corticosteroids for Treatment of Moderate to Severe Atopic Dermatitis: A Randomized Clinical Trial.,"Importance


Baricitinib, an oral selective Janus kinase 1 and 2 inhibitor, effectively reduced disease severity in moderate to severe atopic dermatitis (AD) in 2 phase 3 monotherapy studies.
Objective


To assess the efficacy and safety of 4 mg and 2 mg of baricitinib in combination with background topical corticosteroid (TCS) therapy in adults with moderate to severe AD who previously had an inadequate response to TCS therapy.
Design, Setting, and Participants


This double-blind, placebo-controlled, phase 3 randomized clinical trial, BREEZE-AD7 (Study of Baricitinib [LY3009104] in Combination With Topical Corticosteroids in Adults With Moderate to Severe Atopic Dermatitis) was conducted from November 16, 2018, to August 22, 2019, at 68 centers across 10 countries in Asia, Australia, Europe, and South America. Patients 18 years or older with moderate to severe AD and an inadequate response to TCSs were included. After completing the study, patients were followed up for up to 4 weeks or enrolled in a long-term extension study.
Interventions


Patients were randomly assigned (1:1:1) to receive 2 mg of baricitinib once daily (n = 109), 4 mg of baricitinib once daily (n = 111), or placebo (n = 109) for 16 weeks. The use of low-to-moderate potency TCSs was allowed.
Main Outcomes and Measures


The primary end point was the proportion of patients achieving a validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of 0 (clear) or 1 (almost clear), with a 2-point or greater improvement from baseline at week 16.
Results


Among 329 patients (mean [SD] age, 33.8 [12.4] years; 216 [66%] male), at week 16, a vIGA-AD score of 0 (clear) or 1 (almost clear) was achieved by 34 patients (31%) receiving 4 mg of baricitinib and 26 (24%) receiving 2 mg of baricitinib compared with 16 (15%) receiving placebo (odds ratio vs placebo, 2.8 [95% CI, 1.4-5.6]; P = .004 for the 4-mg group; 1.9 [95% CI, 0.9-3.9]; P = .08 for the 2-mg group). Treatment-emergent adverse events were reported in 64 of 111 patients (58%) in the 4-mg group, 61 of 109 patients (56%) in the 2-mg group, and 41 of 108 patients (38%) in the placebo group. Serious adverse events were reported in 4 patients (4%) in the 4-mg group, 2 (2%) in the 2-mg group, and 4 (4%) in the placebo group. The most common adverse events were nasopharyngitis, upper respiratory tract infections, and folliculitis.
Conclusions and Relevance


A dose of 4 mg of baricitinib in combination with background TCS therapy significantly improved the signs and symptoms of moderate to severe AD, with a safety profile consistent with previous studies of baricitinib in AD.
Trial Registration


ClinicalTrials.gov Identifier: NCT03733301.",2020,"Treatment-emergent adverse events were reported in 64 of 111 patients (58%) in the 4-mg group, 61 of 109 patients (56%) in the 2-mg group, and 41 of 108 patients (38%) in the placebo group.","['329 patients (mean [SD] age', 'Patients 18 years or older with moderate to severe AD and an inadequate response to TCSs were included', 'adults with moderate to severe AD who previously had an inadequate response to TCS therapy', 'Adults With Moderate to Severe Atopic Dermatitis) was conducted from November 16, 2018, to August 22, 2019, at 68 centers across 10 countries in Asia, Australia, Europe, and South America', 'Moderate to Severe Atopic Dermatitis', 'moderate to severe atopic dermatitis (AD) in 2 phase 3 monotherapy studies']","['Baricitinib Combined With Topical Corticosteroids', 'baricitinib in combination with background topical corticosteroid (TCS) therapy', 'Topical Corticosteroids', 'baricitinib in combination with background TCS therapy', 'placebo', 'baricitinib once daily (n\u2009=\u2009109), 4 mg of baricitinib once daily (n\u2009=\u2009111), or placebo']","['proportion of patients achieving a validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of 0 (clear) or 1 (almost clear', 'efficacy and safety', 'Serious adverse events', 'Treatment-emergent adverse events', 'Efficacy and Safety', 'nasopharyngitis, upper respiratory tract infections, and folliculitis', 'signs and symptoms of moderate to severe AD']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0149783', 'cui_str': 'Administration of steroid'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0037713', 'cui_str': 'South America'}, {'cui': 'C0439560', 'cui_str': 'Phase 2'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C4044947', 'cui_str': 'baricitinib'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0149783', 'cui_str': 'Administration of steroid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C4517538', 'cui_str': '111'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0521097', 'cui_str': 'Cleared by'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}, {'cui': 'C0041912', 'cui_str': 'Upper respiratory infection'}, {'cui': 'C0016436', 'cui_str': 'Folliculitis'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]",,0.414119,"Treatment-emergent adverse events were reported in 64 of 111 patients (58%) in the 4-mg group, 61 of 109 patients (56%) in the 2-mg group, and 41 of 108 patients (38%) in the placebo group.","[{'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Reich', 'Affiliation': 'Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Kabashima', 'Affiliation': 'Department of Dermatology, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Ketty', 'Initials': 'K', 'LastName': 'Peris', 'Affiliation': 'Dermatologia, Fondazione Policlinico Universitario A. Gemelli IRCCS- Università Cattolica del Sacro Cuore, Rome, Italy.'}, {'ForeName': 'Jonathan I', 'Initials': 'JI', 'LastName': 'Silverberg', 'Affiliation': 'Department of Dermatology, George Washington University School of Medicine, Washington, DC.'}, {'ForeName': 'Lawrence F', 'Initials': 'LF', 'LastName': 'Eichenfield', 'Affiliation': ""Department of Dermatology, University of California, San Diego and Rady Children's Hospital, San Diego, California.""}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bieber', 'Affiliation': 'Department of Dermatology and Allergy, University Hospital of Bonn, Bonn, Germany.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Kaszuba', 'Affiliation': 'Dermed Centrum Medyczne, Lodz, Poland.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Kolodsick', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Fan E', 'Initials': 'FE', 'LastName': 'Yang', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Gamalo', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Dennis R', 'Initials': 'DR', 'LastName': 'Brinker', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Amy M', 'Initials': 'AM', 'LastName': 'DeLozier', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Janes', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Fabio P', 'Initials': 'FP', 'LastName': 'Nunes', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Jacob P', 'Initials': 'JP', 'LastName': 'Thyssen', 'Affiliation': 'Department of Dermatology and Allergy, Herlev and Gentofte Hospital, University of Copenhagen, Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Eric L', 'Initials': 'EL', 'LastName': 'Simpson', 'Affiliation': 'Department of Dermatology, Oregon Health and Science University, Portland.'}]",JAMA dermatology,['10.1001/jamadermatol.2020.3260']
3073,32997836,One- versus two-stage crown lengthening surgical procedure for aesthetic restorative purposes: A randomized controlled trial.,"AIM


This randomized controlled trial aimed to assess the efficacy of a two-stage crown lengthening intervention (SCL) in the aesthetic zone compared with a one-stage crown lengthening procedure (CCL).
MATERIALS AND METHODS


Thirty subjects were randomly assigned to either SCL (n = 15) or CCL (n = 15) groups. SCL consisted of full-thickness flaps followed by bone recontouring and gingivectomy 4 months postoperatively, if required. In CCL, osseous recontouring after submarginal incisions was performed, followed by flap repositioning. Records were obtained at baseline, 4 months (only in SCL), 6 months and 12 months. Primary outcome was the precision in achieving a pre-determined gingival margin position. Other outcomes considered were changes in the gingival margin position and keratinized tissue width (KTW) at 12 months, and patient-reported outcomes (PROMs).
RESULTS


Surgical precision was comparable between groups (0.2 ± 0.4 mm in the CCL group and -0.2 ± 0.5 mm in the SCL group). Four patients in the SCL group (27.7%) did not require a second-stage surgery. KTW was significantly higher in the SCL group (6.3 ± 1.4 mm versus 5.0 ± 1.4 mm, p = 0.017). SCL resulted in a lower impact on quality of life when compared to the CCL group.
CONCLUSIONS


Both approaches were highly accurate obtaining the desired crown length. SCL was associated with a lower reduction in KTW and more favourable oral health-related quality of life (OHIP-14).",2020,SCL was associated with a lower reduction of KTW and more favorable oral health related quality of life (OHIP-14).,"['Aesthetic Restorative Purposes', 'Thirty subjects']","['CCL', 'SCL', 'two-stage crown lengthening intervention (SCL']","['KTW width', 'precision in achieving a predetermined gingival margin position', 'Surgical precision', 'gingival margin position and keratinized tissue width (KTW', 'quality of life', 'favorable oral health related quality of life (OHIP-14']","[{'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C1285529', 'cui_str': 'Purpose'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C0007537', 'cui_str': 'Cefaclor'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0085146', 'cui_str': 'Crown lengthening'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0010384', 'cui_str': 'Crown'}, {'cui': 'C0392744', 'cui_str': 'Lengthened'}]","[{'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}]",30.0,0.149131,SCL was associated with a lower reduction of KTW and more favorable oral health related quality of life (OHIP-14).,"[{'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'González-Martín', 'Affiliation': 'Faculty of Odontology, University Complutense of Madrid, Madrid, Spain.'}, {'ForeName': 'Georgina', 'Initials': 'G', 'LastName': 'Carbajo', 'Affiliation': 'Faculty of Odontology, University Complutense of Madrid, Madrid, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Rodrigo', 'Affiliation': 'Faculty of Odontology, University Complutense of Madrid, Madrid, Spain.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Montero', 'Affiliation': 'Faculty of Odontology, University Complutense of Madrid, Madrid, Spain.'}, {'ForeName': 'Mariano', 'Initials': 'M', 'LastName': 'Sanz', 'Affiliation': 'Faculty of Odontology, University Complutense of Madrid, Madrid, Spain.'}]",Journal of clinical periodontology,['10.1111/jcpe.13375']
3074,33002305,Pulmonary metastasectomy in colorectal cancer: health utility scores by EQ-5D-3L in a randomized controlled trial show no benefit from lung metastasectomy.,"AIM


The aim was to assess the health utility of lung metastasectomy in the treatment of patients with colorectal cancer (CRC) using the EQ-5D-3L questionnaire.
METHODS


Multidisciplinary CRC teams at 14 sites recruited patients to a two-arm randomized controlled trial-Pulmonary Metastasectomy in Colorectal Cancer (PulMiCC). Remote randomization was used, stratified by site and with minimization for seven known confounders. Participants completed the EQ-5D-3L questionnaire together with other patient reported outcome measures at randomization and then again at 3, 6, 12 and 24 months. These were returned by post to the coordinating centre.
RESULTS


Between December 2010 and December 2016, 93 participants were randomized, 91 of whom returned questionnaires. Survival and patient reported quality of life have been published previously, revealing no significant differences between the trial arms. Described here are patient reported data from the five dimensions of the EQ-5D-3L and the visual analogue scale (VAS) health state. No significant difference was seen at any time point. The estimated difference between control and metastasectomy patients was -0.23 (95% CI -0.113, 0.066) for the composite 0 to 1 index scale based on the descriptive system and 0.123 (95% CI -7.24, 7.49) for the 0 to 100 VAS scale.
CONCLUSIONS


Following lung metastasectomy for CRC, no benefit was demonstrated for health utility, which alongside a lack of a survival or quality of life benefit calls into question the widespread use of the procedure.",2020,"Following lung metastasectomy for colorectal cancer, no benefit was demonstrated for Health Utility, which alongside a lack of a survival or QoL benefit, calls into question the widespread use of the procedure.","['patients with colorectal cancer using the EQ-5D-3L questionnaire', 'Between December 2010 and December 2016', 'Multidisciplinary colorectal cancer teams at 14 sites recruited patients to a 2-arm randomised controlled trial-Pulmonary Metastasectomy in Colorectal Cancer (PulMiCC', '93 participants were randomised 91 of whom returned questionnaires', 'Colorectal Cancer']",[],"['EQ-5D-3L questionnaire', 'Survival', 'Health Utility of lung metastasectomy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C2363923', 'cui_str': 'Metastasectomy'}, {'cui': 'C0332156', 'cui_str': 'Return to'}]",[],"[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C2363923', 'cui_str': 'Metastasectomy'}]",93.0,0.174659,"Following lung metastasectomy for colorectal cancer, no benefit was demonstrated for Health Utility, which alongside a lack of a survival or QoL benefit, calls into question the widespread use of the procedure.","[{'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Brew-Graves', 'Affiliation': 'National Cancer Imaging Translational Accelerator (NCITA), Division of Medicine, UCL, London, UK.'}, {'ForeName': 'Vernon', 'Initials': 'V', 'LastName': 'Farewell', 'Affiliation': 'MRC Biostatistics Unit, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Monson', 'Affiliation': 'Sussex Health Outcomes Research and Education in Cancer (SHORE-C), Brighton and Sussex Medical School, University of Sussex, Falmer, UK.'}, {'ForeName': 'Mišel', 'Initials': 'M', 'LastName': 'Milošević', 'Affiliation': 'Thoracic Surgery Clinic, Institute for Lung Diseases of Vojvodina, Sremska Kamenica, Serbia.'}, {'ForeName': 'Norman R', 'Initials': 'NR', 'LastName': 'Williams', 'Affiliation': 'Surgical and Interventional Trials Unit (SITU), University College London, London, UK.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Morris', 'Affiliation': 'Nuffield Department of Population Health, Big Data Institute, University of Oxford, Oxford, UK.'}, {'ForeName': 'Fergus', 'Initials': 'F', 'LastName': 'Macbeth', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Treasure', 'Affiliation': 'Clinical Operational Research Unit, University College London, London, UK.'}, {'ForeName': 'Lesley', 'Initials': 'L', 'LastName': 'Fallowfield', 'Affiliation': 'Sussex Health Outcomes Research and Education in Cancer (SHORE-C), Brighton and Sussex Medical School, University of Sussex, Falmer, UK.'}]",Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland,['10.1111/codi.15386']
3075,33002731,Gamma-transcranial alternating current stimulation and theta-burst stimulation: inter-subject variability and the role of BDNF.,"OBJECTIVE


The main limitation of neuromodulation techniques is inter-subject variability. Combining theta-burst stimulation (TBS) with gamma-transcranial alternating current stimulation (γ-tACS) allows to shape cortical plasticity. However, it is unknown whether γ-tACS modifies TBS-induced response variability. In this study, we measured the inter-subject variability of TBS-γ tACS and controlled the effect of the Brain-Derived Neurotrophic Factor (BDNF) Val66Met polymorphism.
METHODS


Intermittent TBS (iTBS)-sham tACS, iTBS-γ tACS, continuous TBS (cTBS)-sham tACS, and cTBS-γ tACS were applied in randomised sessions. Inter-subject variability was measured using grand average and clustering methods. TBS-γ tACS effects on motor evoked potentials (MEP) were compared between Val/Val and Met carriers.
RESULTS


We found that γ-tACS boosted iTBS-induced MEP facilitation and cancelled cTBS-induced MEP depression. Grand average analysis showed that γ-tACS prominently increased the percentage of iTBS responders and cTBS non-responders. The clustering method demonstrated that TBS-γ tACS response varied between subjects, a phenomenon unrelated to the BDNF genotype.
CONCLUSIONS


Enhancing γ oscillations through tACS boosts iTBS-induced LTP-like plasticity and suppresses cTBS-induced LTD-like plasticity of the primary motor cortex in a reliable manner. The BDNF Val66Met polymorphism does not influence these effects.
SIGNIFICANCE


Since γ-tACS significantly increases the number of iTBS responders, it may be used in clinical settings.",2020,Grand average analysis showed that γ-tACS prominently increased the percentage of iTBS responders and cTBS non-responders.,[],"['Gamma-transcranial alternating current stimulation and theta-burst stimulation', 'γ-tACS', 'TBS-γ tACS', 'Combining theta-burst stimulation (TBS) with gamma-transcranial alternating current stimulation (γ-tACS', 'TBS (iTBS)-sham tACS, iTBS-γ tACS, continuous TBS (cTBS)-sham tACS, and cTBS-γ tACS']","['motor evoked potentials (MEP', 'TBS-γ tACS response', 'percentage of iTBS responders']",[],"[{'cui': 'C0017011', 'cui_str': 'Gamma radiation'}, {'cui': 'C3852966', 'cui_str': 'Transcranial Alternating Current Stimulation'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}]","[{'cui': 'C0282617', 'cui_str': 'Motor Evoked Potentials'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}]",,0.0513527,Grand average analysis showed that γ-tACS prominently increased the percentage of iTBS responders and cTBS non-responders.,"[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Guerra', 'Affiliation': 'IRCCS Neuromed, Via Atinense 18, 86077 Pozzilli, IS, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Asci', 'Affiliation': ""Department of Human Neurosciences, Sapienza University of Rome, Viale dell'Università 30, 00185 Rome, Italy.""}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Zampogna', 'Affiliation': ""Department of Human Neurosciences, Sapienza University of Rome, Viale dell'Università 30, 00185 Rome, Italy.""}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': ""D'Onofrio"", 'Affiliation': ""Department of Human Neurosciences, Sapienza University of Rome, Viale dell'Università 30, 00185 Rome, Italy.""}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Petrucci', 'Affiliation': ""Department of Clinical and Molecular Medicine, Sapienza University of Rome, Rome, Italy; Sant'Andrea University Hospital, Rome, Italy.""}, {'ForeName': 'Monia', 'Initials': 'M', 'LastName': 'Ginevrino', 'Affiliation': 'Istituto di Medicina Genomica, Università Cattolica del Sacro Cuore, Fondazione Policlinico Universitario ""A. Gemelli"" IRCCS, Rome, Italy; Laboratory of Medical Genetics, Bambino Gesù Children\'s Hospital, Rome, Italy.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Berardelli', 'Affiliation': ""IRCCS Neuromed, Via Atinense 18, 86077 Pozzilli, IS, Italy; Department of Human Neurosciences, Sapienza University of Rome, Viale dell'Università 30, 00185 Rome, Italy. Electronic address: alfredo.berardelli@uniroma1.it.""}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Suppa', 'Affiliation': ""IRCCS Neuromed, Via Atinense 18, 86077 Pozzilli, IS, Italy; Department of Human Neurosciences, Sapienza University of Rome, Viale dell'Università 30, 00185 Rome, Italy.""}]",Clinical neurophysiology : official journal of the International Federation of Clinical Neurophysiology,['10.1016/j.clinph.2020.08.017']
3076,33002745,Comparison of the effectiveness of the virtual simulator and video-assisted teaching on intravenous catheter insertion skills and self-confidence: A quasi-experimental study.,"BACKGROUND


With the advancement of technology, methods such as clinical scenarios, role playing, video demonstration and simulation are now used to develop psychomotor skills in nursing education. Virtual reality and video-assisted teaching are useful technologies for the development of skills and self-confidence. In the literature, there is a lack of studies comparing the effects of the two methods.
OBJECTIVES


The aim of study is to compare the effect of the virtual simulator and video assisted teaching on the level of intravenous catheterization skills and self-confidence of nursing students. Thus, students are enabled to develop skills and work efficiently without the need for an instructor.
METHODS


This study was a randomized controlled quasi-experimental study. A total of 60 students was included in the study (30 in the virtual simulator group and 30 in the video group). In the virtual simulator group, each student performed an intravenous catheter insertion in the virtual intravenous simulator. In the video group, each student watched a training video on the peripheral intravenous catheterization skill in a classroom setting. Each of the students' level of intravenous catheterization knowledge, psychomotor skill and self-confidence score was evaluated.
RESULTS


Post-test knowledge scores was higher than pretest knowledge scores for both groups. There were no significant difference between the groups in terms of post-test scores. Students' scores of psychomotor skills were found to be higher in the virtual simulator group and self-confidence scores were similar in both groups.
CONCLUSION


Teaching with the virtual simulator contributed to the students' skills more than the method used in the video training. Both methods are effective in the development of knowledge and self-confidence related to intravenous catheterization.",2020,"Students' scores of psychomotor skills were found to be higher in the virtual simulator group and self-confidence scores were similar in both groups.
","['60 students was included in the study (30 in the virtual simulator group and 30 in the video group', 'nursing students']","['Virtual reality and video-assisted teaching', 'virtual simulator and video assisted teaching', 'virtual simulator and video-assisted teaching']","[""Students' scores of psychomotor skills"", 'self-confidence scores', 'intravenous catheterization knowledge, psychomotor skill and self-confidence score']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0183309', 'cui_str': 'Simulator'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0038496', 'cui_str': 'Student nurse'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0183309', 'cui_str': 'Simulator'}]","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",60.0,0.0559607,"Students' scores of psychomotor skills were found to be higher in the virtual simulator group and self-confidence scores were similar in both groups.
","[{'ForeName': 'Elif Günay', 'Initials': 'EG', 'LastName': 'İsmailoğlu', 'Affiliation': 'Izmir Bakircay University, İzmir, Turkey. Electronic address: elif.ismailoglu@bakircay.edu.tr.'}, {'ForeName': 'Nilay', 'Initials': 'N', 'LastName': 'Orkun', 'Affiliation': 'Ege University, İzmir, Turkey.'}, {'ForeName': 'İsmet', 'Initials': 'İ', 'LastName': 'Eşer', 'Affiliation': 'Ege University, İzmir, Turkey.'}, {'ForeName': 'Ayten', 'Initials': 'A', 'LastName': 'Zaybak', 'Affiliation': 'Ege University, İzmir, Turkey.'}]",Nurse education today,['10.1016/j.nedt.2020.104596']
3077,33002752,A comparison of ultrasound-guided rotator interval and posterior glenohumeral injection techniques for MR shoulder arthrography.,"PURPOSE


The aim of this prospective, randomized study was to compare the performance of a rotator interval approach with the posterior glenohumeral approach for ultrasound-guided contrast injection prior to MR shoulder arthrography.
METHOD


This study was approved by the institutional review board. One hundred and twenty consecutive patients referred for MR shoulder arthrography were randomized into four groups: rotator interval approach in-plane (n = 30); rotator interval approach out-of-plane (n = 30); posterior approach in-plane (n = 30); and posterior approach out-of plane (n = 30). Outcome measures included procedure time, number of injection attempts, patient-reported pain score (0-10), and radiologist-reported technical difficulty (0-10). MR arthrograms were assessed for adequacy of joint distension, diagnostic utility, and extra-capsular contrast leakage.
RESULTS


All 120 patients had a successful ultrasound-guided injection with adequate joint distension and diagnostic utility for MR arthrography. In-plane needle guidance was less technically demanding, quicker, required fewer injection attempts, and had a lower frequency of contrast leakage than out-of-plane needle guidance. The posterior glenohumeral approach was less technically demanding though had a higher frequency of contrast leakage and caused more patient discomfort than the rotator interval approach.
CONCLUSION


For ultrasound-guided shoulder joint injection, an in-plane approach is preferable. The posterior glenohumeral approach is less technically demanding though causes more patients discomfort than the rotator interval approach possibly due to the longer needle path.",2020,"In-plane needle guidance was less technically demanding, quicker, required fewer injection attempts, and had a lower frequency of contrast leakage than out-of-plane needle guidance.","['One hundred and twenty consecutive patients referred for MR shoulder arthrography', 'MR shoulder arthrography', 'All 120 patients had a successful ultrasound-guided injection with adequate joint distension and diagnostic utility for MR arthrography']","['posterior glenohumeral approach for ultrasound-guided contrast injection', 'ultrasound-guided rotator interval and posterior glenohumeral injection techniques', 'rotator interval approach in-plane (n\xa0=\xa030); rotator interval approach out-of-plane (n\xa0=\xa030); posterior approach in-plane (n\xa0=\xa030); and posterior approach out-of plane']","['procedure time, number of injection attempts, patient-reported pain score (0-10), and radiologist-reported technical difficulty (0-10', 'patient discomfort', 'adequacy of joint distension, diagnostic utility, and extra-capsular contrast leakage']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0203224', 'cui_str': 'Arthrography of shoulder'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0003885', 'cui_str': 'Arthrography'}]","[{'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C2960425', 'cui_str': 'Injection technique'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0205512', 'cui_str': 'Posterior approach'}]","[{'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0260194', 'cui_str': 'Radiologist'}, {'cui': 'C0282419', 'cui_str': 'Technical Report'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205151', 'cui_str': 'Capsular'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0015376', 'cui_str': 'Extravasation'}]",120.0,0.0381212,"In-plane needle guidance was less technically demanding, quicker, required fewer injection attempts, and had a lower frequency of contrast leakage than out-of-plane needle guidance.","[{'ForeName': 'Carita', 'Initials': 'C', 'LastName': 'Tsoi', 'Affiliation': 'Department of Imaging & Interventional Radiology, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Chris S C', 'Initials': 'CSC', 'LastName': 'Tsai', 'Affiliation': 'Department of Imaging & Interventional Radiology, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Eric K C', 'Initials': 'EKC', 'LastName': 'Law', 'Affiliation': 'Department of Imaging & Interventional Radiology, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Ryan K L', 'Initials': 'RKL', 'LastName': 'Lee', 'Affiliation': 'Department of Imaging & Interventional Radiology, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Alex W H', 'Initials': 'AWH', 'LastName': 'Ng', 'Affiliation': 'Department of Imaging & Interventional Radiology, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Griffith', 'Affiliation': 'Department of Imaging & Interventional Radiology, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong. Electronic address: griffith@cuhk.edu.hk.'}]",Clinical imaging,['10.1016/j.clinimag.2020.08.031']
3078,33002791,Results of a Pilot Trial of a Lifestyle Intervention for Stroke Survivors: Healthy Eating and Lifestyle after Stroke.,"OBJECTIVES


Although healthy lifestyle practices mitigate recurrent stroke risk and mortality, few stroke survivors adhere to them, particularly among socioeconomically disadvantaged communities. We developed and pilot tested a occupational therapy-based lifestyle management intervention, Healthy Eating And Lifestyle after Stroke (HEALS), to improve stroke survivors' self-management skills relating to diet and physical activity and evaluated it in a diverse safety-net population.
MATERIALS AND METHODS


One hundred English- or Spanish-speaking participants with stroke or transient ischemic attack were randomized to a 6-week occupational therapist-led group lifestyle intervention vs. usual care. Each of the six 2-h group sessions included didactic presentations on diet and physical activity, peer exchange, personal exploration with goal setting, and direct experience through participation in a relevant activity. Primary outcomes at 6 months were change in body mass index, fruit/vegetable intake, and physical activity. Secondary outcomes included change in waist circumference, smoking, blood pressure, high-density lipoprotein, low-density lipoprotein, triglyceride, total cholesterol, glycosylated hemoglobin levels, quality of care, and perceptions of care. Effect sizes were determined in preparation for a larger randomized controlled trial powered to detect a difference in primary outcomes. A nested formative evaluation assessed facilitators and barriers to implementation, acceptance, and intervention adherence.
RESULTS


There were no significant changes in primary or secondary outcomes at 6 months. Effect sizes for all outcomes were small (< 0.2). Focus group participants recommended extending the intervention program duration with more sessions, additional information on stroke and vascular risk factors, an interdisciplinary approach, additional family involvement, and incentives. Providers recommended longer program duration, more training, fidelity checks to ensure standardized program delivery, and additional incentives for participants.
CONCLUSIONS


The HEALS intervention was feasible in a safety-net setting, but effect sizes were small. A longer-duration intervention, with intervener fidelity checks may be warranted.
TRIAL REGISTRATION


NCT01550822.",2020,There were no significant changes in primary or secondary outcomes at 6 months.,"['One hundred English- or Spanish-speaking participants with stroke or transient ischemic attack', 'Stroke Survivors', 'Healthy Eating and Lifestyle after Stroke']","['HEALS intervention', 'occupational therapist-led group lifestyle intervention vs. usual care', 'intervention program duration with more sessions, additional information on stroke and vascular risk factors, an interdisciplinary approach, additional family involvement, and incentives', 'didactic presentations on diet and physical activity, peer exchange, personal exploration with goal setting, and direct experience through participation in a relevant activity', 'occupational therapy-based lifestyle management intervention, Healthy Eating And Lifestyle after Stroke (HEALS', 'Lifestyle Intervention']","['change in waist circumference, smoking, blood pressure, high-density lipoprotein, low-density lipoprotein, triglyceride, total cholesterol, glycosylated hemoglobin levels, quality of care, and perceptions of care', 'change in body mass index, fruit/vegetable intake, and physical activity']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0023676', 'cui_str': 'Life style'}]","[{'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0028807', 'cui_str': 'Occupational therapist'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1280903', 'cui_str': 'Exploration procedure'}, {'cui': 'C0150598', 'cui_str': 'Goal setting'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1318464', 'cui_str': 'Occupational therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0034379', 'cui_str': 'Quality of Care'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0556223', 'cui_str': 'Vegetable intake'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",,0.121269,There were no significant changes in primary or secondary outcomes at 6 months.,"[{'ForeName': 'Amytis', 'Initials': 'A', 'LastName': 'Towfighi', 'Affiliation': 'Los Angeles County + University of Southern California Medical Center, 1100 N State St, A4E, Los Angeles, CA 90033, United States; Rancho Los Amigos National Rehabilitation Center, Downey, CA, United States; Los Angeles County Department of Health Services, Los Angeles, CA, United States. Electronic address: towfighi@usc.edu.'}, {'ForeName': 'Eric M', 'Initials': 'EM', 'LastName': 'Cheng', 'Affiliation': 'University of California, Los Angeles, Los Angeles, CA, United States.'}, {'ForeName': 'Valerie A', 'Initials': 'VA', 'LastName': 'Hill', 'Affiliation': 'Rancho Los Amigos National Rehabilitation Center, Downey, CA, United States; University of Cincinnati, Cincinnati, OH, United States.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Barry', 'Affiliation': 'University of California, Los Angeles, Los Angeles, CA, United States.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Lee', 'Affiliation': 'University of California, Los Angeles, Los Angeles, CA, United States.'}, {'ForeName': 'Natalie P', 'Initials': 'NP', 'LastName': 'Valle', 'Affiliation': 'St Jude Medical Center, Fullerton, CA, United States. Electronic address: Natalie.valle@stjoe.org.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Mittman', 'Affiliation': 'Kaiser Permanente, Los Angeles, CA, United States.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Ayala-Rivera', 'Affiliation': 'Los Angeles County + University of Southern California Medical Center, 1100 N State St, A4E, Los Angeles, CA 90033, United States.'}, {'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Moreno', 'Affiliation': 'Rancho Los Amigos National Rehabilitation Center, Downey, CA, United States.'}, {'ForeName': 'Annaliese', 'Initials': 'A', 'LastName': 'Espinosa', 'Affiliation': 'Rancho Los Amigos National Rehabilitation Center, Downey, CA, United States.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Dombish', 'Affiliation': 'Rancho Los Amigos National Rehabilitation Center, Downey, CA, United States.'}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Rancho Los Amigos National Rehabilitation Center, Downey, CA, United States.'}, {'ForeName': 'Dina', 'Initials': 'D', 'LastName': 'Ochoa', 'Affiliation': 'Rancho Los Amigos National Rehabilitation Center, Downey, CA, United States.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Chu', 'Affiliation': 'Los Angeles County + University of Southern California Medical Center, 1100 N State St, A4E, Los Angeles, CA 90033, United States. Electronic address: chu381@usc.edu.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Atkins', 'Affiliation': 'Rancho Los Amigos National Rehabilitation Center, Downey, CA, United States.'}, {'ForeName': 'Barbara G', 'Initials': 'BG', 'LastName': 'Vickrey', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, United States.'}]",Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association,['10.1016/j.jstrokecerebrovasdis.2020.105323']
3079,33007442,Operationalizing needs-focused palliative care for older adults in intensive care units: Design of and rationale for the PCplanner randomized clinical trial.,"INTRODUCTION


The number of older adults who receive life support in an intensive care unit (ICU), now 2 million per year, is increasing while survival remains unchanged. Because the quality of ICU-based palliative care is highly variable, we developed a mobile app intervention that integrates into the electronic health records (EHR) system called PCplanner (Palliative Care planner) with the goal of improving collaborative primary and specialist palliative care delivery in ICU settings.
OBJECTIVE


To describe the methods of a randomized clinical trial (RCT) being conducted to compare PCplanner vs. usual care.
METHODS AND ANALYSIS


The goal of this two-arm, parallel group mixed methods RCT is to determine the clinical impact of the PCplanner intervention on outcomes of interest to patients, family members, clinicians, and policymakers over a 3-month follow up period. The primary outcome is change in unmet palliative care needs measured by the NEST instrument between baseline and 1 week post-randomization. Secondary outcomes include goal concordance of care, patient-centeredness of care, and quality of communication at 1 week post-randomization; length of stay; as well as symptoms of depression, anxiety, and post-traumatic stress disorder at 3 months post-randomization. We will use general linear models for repeated measures to compare outcomes across the main effects and interactions of the factors. We hypothesize that compared to usual care, PCplanner will have a greater impact on the quality of ICU-based palliative care delivery across domains of core palliative care needs, psychological distress, patient-centeredness, and healthcare resource utilization.",2020,"Secondary outcomes include goal concordance of care, patient-centeredness of care, and quality of communication at 1 week post-randomization; length of stay; as well as symptoms of depression, anxiety, and post-traumatic stress disorder at 3 months post-randomization.",['older adults in intensive care units'],"['PCplanner intervention', 'PCplanner vs. usual care']","['goal concordance of care, patient-centeredness of care, and quality of communication at 1\u202fweek post-randomization; length of stay; as well as symptoms of depression, anxiety, and post-traumatic stress disorder', 'change in unmet palliative care needs measured by the NEST instrument']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}]",,0.166302,"Secondary outcomes include goal concordance of care, patient-centeredness of care, and quality of communication at 1 week post-randomization; length of stay; as well as symptoms of depression, anxiety, and post-traumatic stress disorder at 3 months post-randomization.","[{'ForeName': 'Christopher E', 'Initials': 'CE', 'LastName': 'Cox', 'Affiliation': 'Department of Medicine, Division of Pulmonary & Critical Care Medicine and the Program to Support People and Enhance Recovery (ProSPER), Duke University, Durham, NC, United States of America. Electronic address: christopher.cox@duke.edu.'}, {'ForeName': 'Maren K', 'Initials': 'MK', 'LastName': 'Olsen', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University, Durham, NC, United States of America; Durham Center of Innovation to Accelerate Discovery and Practice Transformation, Durham Veterans Affairs Health Care System, Durham, NC, United States of America. Electronic address: maren.olsen@duke.edu.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Casarett', 'Affiliation': 'Department of Medicine, Section of Palliative Care and Hospice Medicine, Duke University, Durham, NC, United States of America. Electronic address: David.casarett@duke.edu.'}, {'ForeName': 'Krista', 'Initials': 'K', 'LastName': 'Haines', 'Affiliation': 'Department of Surgery, Division of Trauma and Critical Care and Acute Care Surgery, Duke University, Durham, North, Carolina;, United States of America. Electronic address: krista.haines@duke.edu.'}, {'ForeName': 'Mashael', 'Initials': 'M', 'LastName': 'Al-Hegelan', 'Affiliation': 'Department of Medicine, Division of Pulmonary & Critical Care Medicine and the Program to Support People and Enhance Recovery (ProSPER), Duke University, Durham, NC, United States of America. Electronic address: mashael.alhegelan@duke.edu.'}, {'ForeName': 'Raquel R', 'Initials': 'RR', 'LastName': 'Bartz', 'Affiliation': 'Department of Anesthesia, Division of Critical Care Medicine, Duke University, Durham, NC, United States of America. Electronic address: raquel.bartz@duke.edu.'}, {'ForeName': 'Jason N', 'Initials': 'JN', 'LastName': 'Katz', 'Affiliation': 'Department of Medicine, Division of Cardiology, Duke University, Durham, NC, United States of America. Electronic address: jason.katz@duke.edu.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Naglee', 'Affiliation': 'Department of Anesthesia, Division of Neurology, Duke University, Durham, NC, United States of America.'}, {'ForeName': 'Deepshikha', 'Initials': 'D', 'LastName': 'Ashana', 'Affiliation': 'Department of Medicine, Division of Pulmonary & Critical Care Medicine and the Program to Support People and Enhance Recovery (ProSPER), Duke University, Durham, NC, United States of America. Electronic address: deepshikha.ashana@duke.edu.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Gilstrap', 'Affiliation': 'Department of Medicine, Division of Pulmonary & Critical Care Medicine and the Program to Support People and Enhance Recovery (ProSPER), Duke University, Durham, NC, United States of America. Electronic address: daniel.gilstrap@duke.edu.'}, {'ForeName': 'Jessie', 'Initials': 'J', 'LastName': 'Gu', 'Affiliation': 'Department of Medicine, Division of Pulmonary & Critical Care Medicine and the Program to Support People and Enhance Recovery (ProSPER), Duke University, Durham, NC, United States of America. Electronic address: jessie.gu@duke.edu.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Parish', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University, Durham, NC, United States of America. Electronic address: alice.parish@duke.edu.'}, {'ForeName': 'Allie', 'Initials': 'A', 'LastName': 'Frear', 'Affiliation': 'Department of Medicine, Division of Pulmonary & Critical Care Medicine and the Program to Support People and Enhance Recovery (ProSPER), Duke University, Durham, NC, United States of America. Electronic address: allie.frear@duke.edu.'}, {'ForeName': 'Deepthi', 'Initials': 'D', 'LastName': 'Krishnamaneni', 'Affiliation': 'Duke Health Technology Solutions, Duke University, Durham, NC, United States of America. Electronic address: deepthi.krishnamaneni@duke.edu.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Corcoran', 'Affiliation': 'Office of Academic Solutions and Information Systems, Duke University, Durham, NC, United States of America. Electronic address: andrew.corcoran@duke.edu.'}, {'ForeName': 'Sharron L', 'Initials': 'SL', 'LastName': 'Docherty', 'Affiliation': 'School of Nursing, Duke University, Durham, NC, United States of America. Electronic address: sharron.docherty@duke.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106163']
3080,33010038,Dupilumab is effective in type 2-high asthma patients receiving high-dose inhaled corticosteroids at baseline.,"BACKGROUND


Dupilumab blocks the shared receptor component for interleukin (IL)-4/IL-13, key drivers of type 2 inflammation. In phase 2b (NCT01854047) and phase 3 LIBERTY ASTHMA QUEST (NCT02414854), add-on dupilumab 200/300 mg every 2 weeks (q2w) reduced severe exacerbations, improved prebronchodilator (pre-BD) forced expiratory volume in 1 second (FEV 1  ) and quality of life measures, and it was generally well tolerated in patients with uncontrolled, persistent (phase 2b), or moderate-to-severe (phase 3) asthma.
METHODS


In patients on high-dose inhaled corticosteroids (ICS) with type 2-high asthma (subgroups including baseline blood eosinophils ≥150/300 cells/µL and/or fractional exhaled nitric oxide [FeNO] ≥25 ppb), annualized severe exacerbation rates over the treatment period, changes from baseline in pre-BD FEV 1  and asthma control (5-item asthma control questionnaire [ACQ-5]) were analyzed.
RESULTS


In high-dose ICS type 2-high subgroups, dupilumab 200/300 mg q2w vs placebo in the phase 2b (24 weeks) and phase 3 (52 weeks) studies significantly reduced severe exacerbations by 55%-69%/57%-60% (all P<.05) and 53%-69%/48%-66% (all P < .001), respectively, except in patients with ≥ 300 eosinophils/µL in phase 2b study (24%/50% (P = .52/0.15). Across subgroups, pre-BD FEV 1  improved by 0.18-0.22 L/0.19-0.24 L (all P < .05) and 0.23-0.36 L/0.15-0.25 L (all P < .01) and ACQ-5 scores were reduced by 0.46-0.55/0.47-0.85 (all P < .05) and 0.38-0.50/0.24-0.30 (all P < .05), respectively, except dupilumab 200 mg q2w in phase 2b in patients with FeNO ≥ 25 ppb (0.41; P = .09). Dupilumab was also effective in patients taking medium-dose ICS.
CONCLUSION


Dupilumab significantly reduced severe exacerbations and improved lung function and asthma control in patients with type 2-high asthma on high-dose ICS at baseline.",2020,"Across subgroups, pre-BD FEV 1  improved by 0.18-0.22 L/0.19-0.24 L (all P<.05) and 0.23-0.36 L/0.15-0.25 L (all P<.01) and ACQ-5 scores were reduced by 0.46-0.55/0.47-0.85 (all P<.05) and 0.38-0.50/0.24-0.30 (all P<.05), respectively, except dupilumab 200 mg q2w in phase 2b in patients with FeNO ≥25 ppb (0.41; P=.09).","['patients with type', 'type 2-high asthma patients receiving high-dose inhaled corticosteroids at baseline']","['inhaled corticosteroids (ICS', 'placebo', 'Dupilumab']","['pre-BD FEV 1  and asthma control (5-item Asthma Control Questionnaire [ACQ-5', 'ACQ-5 scores', 'severe exacerbations, improved prebronchodilator (pre-BD) forced expiratory volume in 1 second (FEV 1  ) and quality-of-life measures', 'annualized severe exacerbation rates', 'severe exacerbations', 'lung function and asthma control']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3660996', 'cui_str': 'dupilumab'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2919686', 'cui_str': 'Asthma control questionnaire'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}]",,0.156378,"Across subgroups, pre-BD FEV 1  improved by 0.18-0.22 L/0.19-0.24 L (all P<.05) and 0.23-0.36 L/0.15-0.25 L (all P<.01) and ACQ-5 scores were reduced by 0.46-0.55/0.47-0.85 (all P<.05) and 0.38-0.50/0.24-0.30 (all P<.05), respectively, except dupilumab 200 mg q2w in phase 2b in patients with FeNO ≥25 ppb (0.41; P=.09).","[{'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Bourdin', 'Affiliation': 'Department of Respiratory Diseases, INSERM U1046, University of Montpellier, Montpellier, France.'}, {'ForeName': 'Alberto A', 'Initials': 'AA', 'LastName': 'Papi', 'Affiliation': 'Università degli Studi di Ferrara, Ferrara, Italy.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Corren', 'Affiliation': 'David Geffen School of Medicine at UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'J Christian', 'Initials': 'JC', 'LastName': 'Virchow', 'Affiliation': 'Universitätsmedizin Rostock, Rostock, Germany.'}, {'ForeName': 'Megan S', 'Initials': 'MS', 'LastName': 'Rice', 'Affiliation': 'Sanofi, Cambridge, MA, USA.'}, {'ForeName': 'Yamo', 'Initials': 'Y', 'LastName': 'Deniz', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Djandji', 'Affiliation': 'Sanofi, Cambridge, MA, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Rowe', 'Affiliation': 'Sanofi, Bridgewater, NJ, USA.'}, {'ForeName': 'Ian D', 'Initials': 'ID', 'LastName': 'Pavord', 'Affiliation': 'University of Oxford, Oxford, UK.'}]",Allergy,['10.1111/all.14611']
3081,33026166,Identifying the best regimen for primary eradication of Helicobacter pylori: analysis of 240 cases.,"The treatment regimen for the eradication of Helicobacter pylori may be best when therapy is susceptibility guided. However, it is unrealistic to use a strategy based on susceptibility testing to prioritize therapy for every patient in China. Empirical therapy of H. pylori is still widely used. The study was designed to discuss the best first-line treatment regimen depending on empirical therapy. The focal point of the study was the optimal length of the therapy. Also, the selection of antibiotics was discussed in the article. This was a prospective, randomized, non-inferiority trial. H. pylori-infected patients who have no previous eradication therapy were randomly assigned to the following: 20 mg of rabeprazole, 1000 mg of amoxicillin, 500 mg of clarithromycin, and 220 mg of bismuth potassium citrate (BACPPI), administered twice a day for 10 or 14 days. The efficacy, side effects, and remission rate of clinical symptoms were determined. A total of 240 subjects were included in the study. The eradication rate with 14 and 10 days was essentially identical in both intention-to-treat (90.83% [95% CI, 86%-96%] vs. 87.50% [95% CI, 82%-93%]) and per-protocol (94.78% [95% CI, 91%-99%] vs. 92.11% [95% CI, 87%-97%]) analyses. Loss of appetite and belching symptoms were significantly better in the BACPPI-10 group than those in the control group after treatment. Side effects were generally mild and similar between groups. Our results showed that a 10-day amoxicillin-clarithromycin-containing bismuth quadruple therapy may be recommended for the primary empirical treatment of H. pylori infection in Beijing, China.",2020,Loss of appetite and belching symptoms were significantly better in the BACPPI-10 group than those in the control group after treatment.,"['H.\xa0pylori-infected patients who have no previous eradication therapy', '240 cases', 'A total of 240 subjects were included in the study']","['amoxicillin-clarithromycin-containing bismuth quadruple therapy', 'BACPPI-10', 'rabeprazole', 'amoxicillin, 500\xa0mg of clarithromycin, and 220\xa0mg of bismuth potassium citrate (BACPPI']","['eradication rate', 'Side effects', 'efficacy, side effects, and remission rate of clinical\xa0symptoms', 'Loss of appetite and belching symptoms']","[{'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0055856', 'cui_str': 'Clarithromycin'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0005642', 'cui_str': 'Bismuth'}, {'cui': 'C0205175', 'cui_str': 'Quadruple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0378482', 'cui_str': 'rabeprazole'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0137996', 'cui_str': 'potassium citrate'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003123', 'cui_str': 'Anorexia'}, {'cui': 'C0014724', 'cui_str': 'Eructation'}]",240.0,0.0356055,Loss of appetite and belching symptoms were significantly better in the BACPPI-10 group than those in the control group after treatment.,"[{'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Traditional Chinese Medicine, Peking University International Hospital, Beijing, China.'}, {'ForeName': 'Qingyi', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Department of Domestic Department One, The Second Medical Center of Chinese, PLA General Hospital, Beijing, China.'}, {'ForeName': 'Fulian', 'Initials': 'F', 'LastName': 'Hu', 'Affiliation': 'Department of Gastroenterology, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Jizheng', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Department of Gastroenterology, Xiyuan Hospital, Beijing, China.'}]",MicrobiologyOpen,['10.1002/mbo3.1120']
3082,33022010,"Midwifery continuity of care versus standard maternity care for women at increased risk of preterm birth: A hybrid implementation-effectiveness, randomised controlled pilot trial in the UK.","BACKGROUND


Midwifery continuity of care is the only health system intervention shown to reduce preterm birth (PTB) and improve perinatal survival, but no trial evidence exists for women with identified risk factors for PTB. We aimed to assess feasibility, fidelity, and clinical outcomes of a model of midwifery continuity of care linked with a specialist obstetric clinic for women considered at increased risk for PTB.
METHODS AND FINDINGS


We conducted a hybrid implementation-effectiveness, randomised, controlled, unblinded, parallel-group pilot trial at an inner-city maternity service in London (UK), in which pregnant women identified at increased risk of PTB were randomly assigned (1:1) to either midwifery continuity of antenatal, intrapartum, and postnatal care (Pilot study Of midwifery Practice in Preterm birth Including women's Experiences [POPPIE] group) or standard care group (maternity care by different midwives working in designated clinical areas). Pregnant women attending for antenatal care at less than 24 weeks' gestation were eligible if they fulfilled one or more of the following criteria: previous cervical surgery, cerclage, premature rupture of membranes, PTB, or late miscarriage; previous short cervix or short cervix this pregnancy; or uterine abnormality and/or current smoker of tobacco. Feasibility outcomes included eligibility, recruitment and attrition rates, and fidelity of the model. The primary outcome was a composite of appropriate and timely interventions for the prevention and/or management of preterm labour and birth. We analysed by intention to treat. Between 9 May 2017 and 30 September 2018, 334 women were recruited; 169 women were allocated to the POPPIE group and 165 to the standard group. Mean maternal age was 31 years; 32% of the women were from Black, Asian, and ethnic minority groups; 70% were in employment; and 46% had a university degree. Nearly 70% of women lived in areas of social deprivation. More than a quarter of women had at least one pre-existing medical condition and multiple risk factors for PTB. More than 75% of antenatal and postnatal visits were provided by a named/partner midwife, and a midwife from the POPPIE team was present at 80% of births. The incidence of the primary composite outcome showed no statistically significant difference between groups (POPPIE group 83.3% versus standard group 84.7%; risk ratio 0.98 [95% confidence interval (CI) 0.90 to 1.08]; p = 0.742). Infants in the POPPIE group were significantly more likely to have skin-to-skin contact after birth, to have it for a longer time, and to breastfeed immediately after birth and at hospital discharge. There were no differences in other secondary outcomes. The number of serious adverse events was similar in both groups and unrelated to the intervention (POPPIE group 6 versus standard group 5). Limitations of this study included the limited power and the nonmasking of group allocation; however, study assignment was masked to the statistician and researchers who analysed the data.
CONCLUSIONS


In this study, we found that it is feasible to set up and achieve fidelity of a model of midwifery continuity of care linked with specialist obstetric care for women at increased risk of PTB in an inner-city maternity service in London (UK), but there is no impact on most outcomes for this population group. Larger appropriately powered trials are needed, including in other settings, to evaluate the impact of relational continuity and hypothesised mechanisms of effect based on increased trust and engagement, improved care coordination, and earlier referral on disadvantaged communities, including women with complex social factors and social vulnerability.
TRIAL REGISTRATION


We prospectively registered the pilot trial on the UK Clinical Research Network Portfolio Database (ID number: 31951, 24 April 2017). We registered the trial on the International Standard Randomised Controlled Trial Number (ISRCTN) (Number: 37733900, 21 August 2017) and before trial recruitment was completed (30 September 2018) when informed that prospective registration for a pilot trial was also required in a primary clinical trial registry recognised by WHO and the International Committee of Medical Journal Editors (ICMJE). The protocol as registered and published has remained unchanged, and the analysis conforms to the original plan.",2020,The incidence of the primary composite outcome showed no statistically significant difference between groups (POPPIE group 83.3% versus standard group 84.7%; risk ratio 0.98 [95% confidence interval (CI) 0.90 to 1.08]; p = 0.742).,"['Mean maternal age was 31 years; 32% of the women were from Black, Asian, and ethnic minority groups; 70% were in employment; and 46% had a university degree', ""Pregnant women attending for antenatal care at less than 24 weeks' gestation were eligible if they fulfilled one or more of the following criteria: previous cervical surgery, cerclage, premature rupture of membranes, PTB, or late miscarriage; previous short cervix or short cervix this pregnancy; or uterine abnormality and/or current smoker of tobacco"", ' (Number: 37733900, 21 August 2017) and before trial recruitment was completed (30 September 2018) when informed that prospective registration for a pilot trial was also required in a primary clinical trial registry recognised by WHO and the International Committee of Medical Journal Editors (ICMJE', 'inner-city maternity service in London (UK), in which pregnant women identified at increased risk of PTB', 'women at increased risk of preterm birth', 'women with identified risk factors for PTB', 'women at increased risk of PTB in an inner-city maternity service in London (UK', 'Between 9 May 2017 and 30 September 2018, 334 women were recruited; 169 women']","['POPPIE', ""midwifery continuity of antenatal, intrapartum, and postnatal care (Pilot study Of midwifery Practice in Preterm birth Including women's Experiences [POPPIE] group) or standard care group (maternity care by different midwives working in designated clinical areas"", 'Midwifery continuity of care versus standard maternity care']","['eligibility, recruitment and attrition rates, and fidelity of the model', 'composite of appropriate and timely interventions for the prevention and/or management of preterm labour and birth', 'preterm birth (PTB) and improve perinatal survival', 'skin-to-skin contact', 'number of serious adverse events']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0024915', 'cui_str': 'Maternal age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0557351', 'cui_str': 'Employed'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0205447', 'cui_str': '1'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1292825', 'cui_str': 'Cerclage'}, {'cui': 'C0015944', 'cui_str': 'Premature rupture of membranes'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C4324509', 'cui_str': 'Late miscarriage'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0007874', 'cui_str': 'Cervix uteri structure'}, {'cui': 'C0266383', 'cui_str': 'Congenital uterine anomaly'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0700287', 'cui_str': 'Informing'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0162443', 'cui_str': 'Journals as Topic'}, {'cui': 'C0557849', 'cui_str': 'Inner city'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C4517729', 'cui_str': '334'}]","[{'cui': 'C0026082', 'cui_str': 'Midwifery'}, {'cui': 'C0456391', 'cui_str': 'Continuities'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0456337', 'cui_str': 'Intrapartum'}, {'cui': 'C0032782', 'cui_str': 'Postpartum care'}, {'cui': 'C0031928', 'cui_str': 'Pilot Study'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0026083', 'cui_str': 'Professional midwife'}, {'cui': 'C0557351', 'cui_str': 'Employed'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0009853', 'cui_str': 'Continuity of Care'}]","[{'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0022876', 'cui_str': 'Premature labor'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0178795', 'cui_str': 'Perinatal period'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",334.0,0.229271,The incidence of the primary composite outcome showed no statistically significant difference between groups (POPPIE group 83.3% versus standard group 84.7%; risk ratio 0.98 [95% confidence interval (CI) 0.90 to 1.08]; p = 0.742).,"[{'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Fernandez Turienzo', 'Affiliation': ""Department of Women and Children's Health, Faculty of Life Science and Medicine, King's College London, London, United Kingdom.""}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Bick', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, United Kingdom.'}, {'ForeName': 'Annette L', 'Initials': 'AL', 'LastName': 'Briley', 'Affiliation': 'Caring Futures Institute, Flinders University, Adelaide, Australia.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Bollard', 'Affiliation': 'Maternity Services, Lewisham and Greenwich NHS Trust, London, United Kingdom.'}, {'ForeName': 'Kirstie', 'Initials': 'K', 'LastName': 'Coxon', 'Affiliation': ""Department of Midwifery, Kingston University and St. George's, University of London, United Kingdom.""}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Cross', 'Affiliation': 'Department of Public Health, London Borough of Lewisham, London, United Kingdom.'}, {'ForeName': 'Sergio A', 'Initials': 'SA', 'LastName': 'Silverio', 'Affiliation': ""Department of Women and Children's Health, Faculty of Life Science and Medicine, King's College London, London, United Kingdom.""}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Singh', 'Affiliation': ""Department of Women and Children's Health, Faculty of Life Science and Medicine, King's College London, London, United Kingdom.""}, {'ForeName': 'Paul T', 'Initials': 'PT', 'LastName': 'Seed', 'Affiliation': ""Department of Women and Children's Health, Faculty of Life Science and Medicine, King's College London, London, United Kingdom.""}, {'ForeName': 'Rachel M', 'Initials': 'RM', 'LastName': 'Tribe', 'Affiliation': ""Department of Women and Children's Health, Faculty of Life Science and Medicine, King's College London, London, United Kingdom.""}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Shennan', 'Affiliation': ""Department of Women and Children's Health, Faculty of Life Science and Medicine, King's College London, London, United Kingdom.""}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Sandall', 'Affiliation': ""Department of Women and Children's Health, Faculty of Life Science and Medicine, King's College London, London, United Kingdom.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",PLoS medicine,['10.1371/journal.pmed.1003350']
3083,33022367,Design and methods of NYC care calls: An effectiveness trial of telephone-delivered type 2 diabetes self-management support.,"Although problems with type 2 diabetes (T2D) self-management and treatment adherence often co-occur with emotional distress, few translatable intervention approaches are available that can target these related problems in primary care practice settings. The New York City (NYC) Care Calls study is a randomized controlled trial that tests the effectiveness of structured support for diabetes self-management and distress management, delivered via telephone by health educators, in improving glycemic control, self-management and emotional well-being among predominantly ethnic minority and socioeconomically disadvantaged adults with suboptimally controlled T2D. English- and Spanish-speaking adults treated for T2D in NYC primary care practices were recruited based on having an A1C ≥ 7.5% despite being prescribed medications for diabetes. Participants (N = 812) were randomly assigned to a telephonic intervention condition with a stepped protocol of 6-12 phone calls over 1 year, delivered by a health educator, or to a comparison condition of enhanced usual care. The primary outcome is change in A1C over one year, measured at baseline and again approximately 6- and 12-months later. Secondary outcomes measured on the same schedule include blood pressure, patient-reported emotional distress, treatment adherence and self-management behaviors. A comprehensive effectiveness evaluation is guided by the RE-AIM framework (Reach, Effectiveness, Adoption, Implementation, Maintenance) to gather data that can inform dissemination and implementation of the intervention, if successful. This paper describes the study rationale, trial design, and methodology.",2020,"Care Calls study is a randomized controlled trial that tests the effectiveness of structured support for diabetes self-management and distress management, delivered via telephone by health educators, in improving glycemic control, self-management and emotional well-being among predominantly ethnic minority and socioeconomically disadvantaged adults with suboptimally controlled T2D. English- and Spanish-speaking adults treated for T2D in NYC primary care practices were recruited based on having an A1C ≥ 7.5% despite being prescribed medications for diabetes.","['predominantly ethnic minority and socioeconomically disadvantaged adults with suboptimally controlled T2D. English- and Spanish-speaking adults treated for T2D in NYC primary care practices were recruited based on having an A1C\u202f≥\u202f7.5% despite being prescribed medications for diabetes', 'Participants (N\u202f=\u202f812']","['telephone-delivered type 2 diabetes self-management support', 'telephonic intervention condition with a stepped protocol of 6-12 phone calls over 1\u202fyear, delivered by a health educator, or to a comparison condition of enhanced usual care', 'New York City (NYC']","['change in A1C over one year', 'blood pressure, patient-reported emotional distress, treatment adherence and self-management behaviors']","[{'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0012613', 'cui_str': 'Disadvantaged'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C0027977', 'cui_str': 'New York City'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1136362', 'cui_str': 'Health educator'}, {'cui': 'C0027977', 'cui_str': 'New York City'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0700361', 'cui_str': 'Emotional distress'}, {'cui': 'C4505265', 'cui_str': 'Therapeutic Adherence'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",812.0,0.067096,"Care Calls study is a randomized controlled trial that tests the effectiveness of structured support for diabetes self-management and distress management, delivered via telephone by health educators, in improving glycemic control, self-management and emotional well-being among predominantly ethnic minority and socioeconomically disadvantaged adults with suboptimally controlled T2D. English- and Spanish-speaking adults treated for T2D in NYC primary care practices were recruited based on having an A1C ≥ 7.5% despite being prescribed medications for diabetes.","[{'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Gonzalez', 'Affiliation': 'Ferkauf Graduate School of Psychology, Yeshiva University, Bronx, NY, USA; Departments of Medicine (Endocrinology) and Epidemiology & Population Health, Albert Einstein College of Medicine, Bronx, NY, USA; The Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine, Bronx, NY, USA. Electronic address: jeffrey.gonzalez@yu.edu.'}, {'ForeName': 'Claire J', 'Initials': 'CJ', 'LastName': 'Hoogendoorn', 'Affiliation': 'Ferkauf Graduate School of Psychology, Yeshiva University, Bronx, NY, USA.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Linnell', 'Affiliation': 'New York City Department of Health and Mental Hygiene, Long Island City, NY, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Fishman', 'Affiliation': 'Ferkauf Graduate School of Psychology, Yeshiva University, Bronx, NY, USA.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Jonas', 'Affiliation': 'Ferkauf Graduate School of Psychology, Yeshiva University, Bronx, NY, USA.'}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Pham-Singer', 'Affiliation': 'New York City Department of Health and Mental Hygiene, Long Island City, NY, USA.'}, {'ForeName': 'Clyde B', 'Initials': 'CB', 'LastName': 'Schechter', 'Affiliation': 'Department of Family and Social Medicine, Albert Einstein College of Medicine, Bronx, NY, USA.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Walker', 'Affiliation': 'Departments of Medicine (Endocrinology) and Epidemiology & Population Health, Albert Einstein College of Medicine, Bronx, NY, USA.'}, {'ForeName': 'Winfred Y', 'Initials': 'WY', 'LastName': 'Wu', 'Affiliation': 'New York City Department of Health and Mental Hygiene, Long Island City, NY, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106166']
3084,33022483,The Norwegian healthy body image intervention promotes positive embodiment through improved self-esteem.,"We examined both direct and indirect effects of the Healthy Body Image (HBI) intervention on positive embodiment among Norwegian high school students. In total, 2446 12th grade boys (43 %) and girls (mean age 16.8 years) from 30 schools participated in a cluster-randomized controlled study with the HBI intervention and a control condition as the study arms. We tested mediation models using path analysis and found that among several hypothesized mediators, only self-esteem mediated a positive intervention effect on positive embodiment for both boys and girls. A direct effect of the intervention on positive embodiment was only found in girls. The study provides novel findings indicating that health promotion interventions to address a positive embodiment should focus on enhancing adolescent's self-esteem. Serial mediation modeling might reveal more complex explanations of change mechanisms and could further evolve current knowledge.",2020,We examined both direct and indirect effects of the Healthy Body Image (HBI) intervention on positive embodiment among Norwegian high school students.,"['girls', 'Norwegian high school students', '2446 12th grade boys (43 %) and girls (mean age 16.8 years) from 30 schools participated in a cluster-randomized controlled study with the']","['HBI intervention', 'Healthy Body Image (HBI) intervention']",['positive embodiment'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0028424', 'cui_str': 'Norwegian language'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517591', 'cui_str': '16.8'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0005891', 'cui_str': 'Body image'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}]",,0.0192935,We examined both direct and indirect effects of the Healthy Body Image (HBI) intervention on positive embodiment among Norwegian high school students.,"[{'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Sundgot-Borgen', 'Affiliation': 'Norwegian School of Sport Sciences, Department of Sports Medicine, Sognsveien 220, N-0806 Oslo, Norway. Electronic address: chrsun@ous-hf.no.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Stenling', 'Affiliation': 'Umeå University, Department of Psychology, 901 87 Umeå, Sweden. Electronic address: andreas.stenling@umu.se.'}, {'ForeName': 'Jan H', 'Initials': 'JH', 'LastName': 'Rosenvinge', 'Affiliation': 'UiT -The Arctic University of Norway, Faculty of Health Sciences Department of Psychology, 9037 Tromsø, Norway. Electronic address: jan.rosenvinge@uit.no.'}, {'ForeName': 'Gunn', 'Initials': 'G', 'LastName': 'Pettersen', 'Affiliation': 'UiT -The Arctic University of Norway, Faculty of Health Sciences Department of Health and Caring Sciences, N- 9037 Tromsø, Norway. Electronic address: gunn.pettersen@uit.no.'}, {'ForeName': 'Oddgeir', 'Initials': 'O', 'LastName': 'Friborg', 'Affiliation': 'UiT -The Arctic University of Norway, Faculty of Health Sciences Department of Psychology, 9037 Tromsø, Norway. Electronic address: oddgeir.friborg@uit.no.'}, {'ForeName': 'Jorunn', 'Initials': 'J', 'LastName': 'Sundgot-Borgen', 'Affiliation': 'Norwegian School of Sport Sciences, Department of Sports Medicine, Sognsveien 220, N-0806 Oslo, Norway. Electronic address: jorunn.sundgot-borgen@nih.no.'}, {'ForeName': 'Elin', 'Initials': 'E', 'LastName': 'Kolle', 'Affiliation': 'Norwegian School of Sport Sciences, Department of Sports Medicine, Sognsveien 220, N-0806 Oslo, Norway. Electronic address: elin.kolle@nih.no.'}, {'ForeName': 'Monica Klungland', 'Initials': 'MK', 'LastName': 'Torstveit', 'Affiliation': 'University of Agder, Faculty of Health and Sport Sciences, Postbox 422, 4604 Kristiansand, Norway. Electronic address: monica.k.torstveit@uia.no.'}, {'ForeName': 'Kethe M E', 'Initials': 'KME', 'LastName': 'Svantorp-Tveiten', 'Affiliation': 'Norwegian School of Sport Sciences, Department of Sports Medicine, Sognsveien 220, N-0806 Oslo, Norway. Electronic address: k.m.e.engen@nih.no.'}, {'ForeName': 'Solfrid', 'Initials': 'S', 'LastName': 'Bratland-Sanda', 'Affiliation': 'University College of Southeast Norway, Department of Sports, Physical Education and Outdoor Studies, P.O. Box 235, N-3603 Kongsberg, Norway. Electronic address: Solfrid.Bratland-Sanda@usn.no.'}]",Body image,['10.1016/j.bodyim.2020.08.014']
3085,32998005,Optimal Dose and Type of β-blockers in Patients With Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention.,"The clinical benefit of β-blockers in modern reperfusion era is not well determined. We investigated the impact of β-blockers in acute coronary syndrome (ACS) after percutaneous coronary intervention. From the Grand-DES registry, a patient-level pooled registry consisting of 5 Korean multicenter prospective drug-eluting stent registries, a total of 6,690 ACS patients were included. Prescription records of dose and type of β-blockers were investigated trimonthly from discharge. Patients were categorized by the mean value of doses during the follow-up (≥50% [high-dose], ≥25% to <50% [medium-dose], and <25% [low-dose] of the full dose that was used in each randomized clinical trial) and vasodilating property of β-blockers. Three-year cumulative risk of all-cause death, cardiac death, and myocardial infarction were assessed. Patients receiving β-blockers were associated with a lower risk of all-cause and cardiac death compared with those not receiving β-blockers (adjusted hazard ratio [aHR] 0.29, 95% confidence interval [CI] 0.24 to 0.35 for all-cause death; aHR 0.27, 95% CI 0.21 to 0.34 for cardiac death). Medium-dose β-blocker group was associated with a lower risk of cardiac death compared with high- and low-dose β-blocker groups (aHR 0.49, 95% CI 0.25 to 0.96, for high-dose; aHR 0.46, 95% CI 0.29 to 0.74, for low-dose). Patients receiving vasodilating β-blockers were associated with a lower risk of cardiac death compared with those receiving conventional β-blockers (aHR 0.58, 95% CI 0.40 to 0.84). In conclusion, β-blocker therapy was associated with better clinical outcomes in patients with ACS, especially with medium-dose and vasodilating β-blockers.",2020,"Patients receiving β-blockers were associated with a lower risk of all-cause and cardiac death compared with those not receiving β-blockers (adjusted hazard ratio [aHR] 0.29, 95% confidence interval [CI] 0.24-0.35 for all-cause death; aHR 0.27, 95% CI 0.21-0.34 for cardiac death).","['acute coronary syndrome (ACS) after percutaneous coronary intervention', 'patients with ACS', 'Patients with Acute Coronary Syndrome', '6,690 ACS patients were included']",['Percutaneous Coronary Intervention'],"['cumulative risk of all-cause death, cardiac death, and myocardial infarction', 'lower risk of all-cause and cardiac death', 'lower risk of cardiac death']","[{'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002455', 'cui_str': 'American Cancer Society'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}]",6690.0,0.127561,"Patients receiving β-blockers were associated with a lower risk of all-cause and cardiac death compared with those not receiving β-blockers (adjusted hazard ratio [aHR] 0.29, 95% confidence interval [CI] 0.24-0.35 for all-cause death; aHR 0.27, 95% CI 0.21-0.34 for cardiac death).","[{'ForeName': 'Jiesuck', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': 'Cardiovascular Center, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Jung-Kyu', 'Initials': 'JK', 'LastName': 'Han', 'Affiliation': 'Cardiovascular Center, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Jeehoon', 'Initials': 'J', 'LastName': 'Kang', 'Affiliation': 'Cardiovascular Center, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'In-Ho', 'Initials': 'IH', 'LastName': 'Chae', 'Affiliation': 'Cardiovascular Center, Seoul National University Bundang Hospital, Seongnam-si, Republic of Korea.'}, {'ForeName': 'Sung Yun', 'Initials': 'SY', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Inje University Ilsan Paik Hospital, Goyang, Republic of Korea.'}, {'ForeName': 'Young Jin', 'Initials': 'YJ', 'LastName': 'Choi', 'Affiliation': 'Department of Internal Medicine, Sejong General Hospital, Bucheon, Republic of Korea.'}, {'ForeName': 'Jay Young', 'Initials': 'JY', 'LastName': 'Rhew', 'Affiliation': 'Department of Internal Medicine and Cardiovascular Center, Presbyterian Medical Center, Jeonju, Republic of Korea.'}, {'ForeName': 'Seung-Woon', 'Initials': 'SW', 'LastName': 'Rha', 'Affiliation': 'Cardiovascular Center, Korea University Guro Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Eun-Seok', 'Initials': 'ES', 'LastName': 'Shin', 'Affiliation': 'Department of Cardiology, Ulsan Medical Center, Ulsan, Republic of Korea.'}, {'ForeName': 'Seong-Ill', 'Initials': 'SI', 'LastName': 'Woo', 'Affiliation': 'Department of Internal Medicine, Inha University Hospital, Incheon, Republic of Korea.'}, {'ForeName': 'Han Cheol', 'Initials': 'HC', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Pusan National University Hospital, Busan, Republic of Korea.'}, {'ForeName': 'Kook-Jin', 'Initials': 'KJ', 'LastName': 'Chun', 'Affiliation': 'Department of Internal Medicine, Pusan National University Yangsan Hospital, Yangsan, Republic of Korea.'}, {'ForeName': 'Doo-Il', 'Initials': 'DI', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Haeundae Paik Hospital, Inje University college of Medicine, Busan, Republic of Korea.'}, {'ForeName': 'Jin-Ok', 'Initials': 'JO', 'LastName': 'Jeong', 'Affiliation': 'Department of Internal Medicine, Chungnam National University School of Medicine, Daejon, Republic of Korea.'}, {'ForeName': 'Jang-Whan', 'Initials': 'JW', 'LastName': 'Bae', 'Affiliation': 'Department of Internal Medicine, Chungbuk National University College of Medicine, Cheongju, Republic of Korea.'}, {'ForeName': 'Han-Mo', 'Initials': 'HM', 'LastName': 'Yang', 'Affiliation': 'Cardiovascular Center, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Kyung Woo', 'Initials': 'KW', 'LastName': 'Park', 'Affiliation': 'Cardiovascular Center, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Hyun-Jae', 'Initials': 'HJ', 'LastName': 'Kang', 'Affiliation': 'Cardiovascular Center, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Bon-Kwon', 'Initials': 'BK', 'LastName': 'Koo', 'Affiliation': 'Cardiovascular Center, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Hyo-Soo', 'Initials': 'HS', 'LastName': 'Kim', 'Affiliation': 'Cardiovascular Center, Seoul National University Hospital, Seoul, Republic of Korea. Electronic address: hyosoo@snu.ac.kr.'}]",The American journal of cardiology,['10.1016/j.amjcard.2020.09.044']
3086,32998018,Glycemic qualification rate and frequency of self-monitoring blood glucose glycemic qualification rate and frequency of self-monitoring blood glucose (SMBG) in women with gestational diabetes mellitus (GDM).,"AIMS


To explore the relationship between blood glucose (BG) control rate and self-monitoring blood glucose (SMBG) compliance of women with gestational diabetes mellitus (GDM).
METHODS


Women with GDM (n = 309) were randomized to receive routine clinical prenatal care or additional online management. Follow-up visits were conducted every two weeks (noted here as T) from enrollment to delivery. SMBG records were used for the analysis.
RESULTS


Both the intervention group and the control group had an increasing BG control rate and decreasing SMBG compliance during the whole follow-up period. Detailed data analysis on separate follow-up periods showed that the SMBG frequency was negatively correlated with the BG control rate in most Ts and that the BG control rate of T n-1  was negatively correlated with the SMBG frequency of T n  in the adjacent T. Only in the intervention group was T 2  SMBG compliance not under the influence of the T 1  BG control rate.
CONCLUSIONS


Our data suggested that regardless of management approach, the BG control rate increased, and the SMBG frequency decreased as gestational weeks increased in women with GDM. Even in separate follow-up periods, the SMBG frequency was negatively correlated with the BG control rate both within one follow-up period and between two adjacent follow-up periods.",2020,Both the intervention group and the control group had an increasing BG control rate and decreasing SMBG compliance during the whole follow-up period.,"['Women with GDM (n=309', 'women with GDM', 'women with gestational diabetes mellitus (GDM']",['routine clinical prenatal care or additional online management'],"['BG control rate and decreasing SMBG compliance', 'Glycemic qualification rate and frequency of self-monitoring blood glucose Glycemic qualification rate and frequency of self-monitoring blood glucose (SMBG', 'blood glucose (BG) control rate and self-monitoring blood glucose (SMBG) compliance', 'BG control rate', 'SMBG frequency of Tn', 'SMBG frequency']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0005803', 'cui_str': 'Self-monitoring of blood glucose'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",309.0,0.0292636,Both the intervention group and the control group had an increasing BG control rate and decreasing SMBG compliance during the whole follow-up period.,"[{'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Tian', 'Affiliation': 'Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Science, Beijing, 100730, China.'}, {'ForeName': 'Suhan', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Science, Beijing, 100730, China.'}, {'ForeName': 'Feiling', 'Initials': 'F', 'LastName': 'Huang', 'Affiliation': 'Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Science, Beijing, 100730, China.'}, {'ForeName': 'Fenglian', 'Initials': 'F', 'LastName': 'Shi', 'Affiliation': 'Zhengzhou Central Hospital Affiliated to Zhengzhou University, No. 16 Tongbai North Road, Zhongyuan District, Zhengzhou, Henan Province 450007, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Shenyang Maternity and Child Health Hospital, No. 41 Shenzhou Road, Shenhe District, Shenyang, Liaoning Province 110000, China.'}, {'ForeName': 'Xiaoxia', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': ""QuanZhou Women's and Children's Hospital, No. 700 Fengze Street, Quanzhou, Fujian Province 362000, China.""}, {'ForeName': 'Chuci', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': ""Shenyang Women's and Children's Hospital, No. 87 Danan Street, Shenhe District, Shenyang, Liaoning Province 110011, China.""}, {'ForeName': 'Hongxiu', 'Initials': 'H', 'LastName': 'Zhong', 'Affiliation': 'Xiamen Maternal and Child Health Hospital, No. 10 Zhenhai Road, Xiamen, Fujian Province 361003, China.'}, {'ForeName': 'Weibo', 'Initials': 'W', 'LastName': 'Ma', 'Affiliation': ""Shunyi Women's & Children's Hospital of Beijing Children's Hospital, No. 1 Shunkang Road, Shunyi District, Beijing 101300, China.""}, {'ForeName': 'Cuiying', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Jinan Maternity and Child Care Hospital Affiliated to Shandong First Medical University, No. 2 Jianguoxiaojingsan Street, Shizhong District, Jinan, Shandong Province 250001, China.'}, {'ForeName': 'Chun', 'Initials': 'C', 'LastName': 'Niu', 'Affiliation': ""Fuyang People's Hospital, No. 63 Luci Street, Yinzhou District, Fuyang, Anhui Province 236004, China.""}, {'ForeName': 'Xiaowen', 'Initials': 'X', 'LastName': 'Xue', 'Affiliation': 'Beijing Pinggu Hospital, No. 59 Xinping North Road, Pinggu District, Beijing 101200, China.'}, {'ForeName': 'Liangkun', 'Initials': 'L', 'LastName': 'Ma', 'Affiliation': 'Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Science, Beijing, 100730, China. Electronic address: MaLiangKun@pumch.cn.'}]",Diabetes research and clinical practice,['10.1016/j.diabres.2020.108482']
3087,33002644,Bilateral nucleus basalis of Meynert deep brain stimulation for dementia with Lewy bodies: A randomised clinical trial.,,2020,,['Dementia with Lewy Bodies'],['Bilateral Nucleus Basalis of Meynert D Brain Stimulation'],[],"[{'cui': 'C0752347', 'cui_str': 'Diffuse Lewy body disease'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0007610', 'cui_str': 'Nucleus'}, {'cui': 'C0870227', 'cui_str': 'Brain stimulation'}]",[],,0.259573,,"[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'Weihai Municipal Hospital, Cheeloo College of Medicine, Shandong University, No.70, Heping Road, Weihai, Shandong, China, 264200. Electronic address: liuwei881x@outlook.com.'}, {'ForeName': 'Dong-Yan', 'Initials': 'DY', 'LastName': 'Yu', 'Affiliation': 'Weihai Municipal Third Hospital, Weihai, Shandong, China, 264205. Electronic address: yudongyan@outlook.com.'}]",Brain stimulation,['10.1016/j.brs.2020.09.020']
3088,33002645,Enhancing cognitive training effects in Alzheimer's disease: rTMS as an add-on treatment.,"The treatment of Alzheimer's disease (AD) in the field of non-pharmacological interventions is a challenging issue, given the limited benefits of the available drugs. Cognitive training (CT) represents a commonly recommended strategy in AD. Recently, repetitive transcranial magnetic stimulation (rTMS) has gained increasing attention as a promising therapeutic tool for the treatment of AD, given its ability of enhancing neuroplasticity. In the present randomized, double-blind, sham-controlled study, we aimed at investigating the add-on effect of a high frequency rTMS protocol applied over the left dorsolateral prefrontal cortex (DLPFC) combined with a face-name associative memory CT in the continuum of AD pathology. Fifty patients from a very early to a moderate phase of dementia were randomly assigned to one of two groups: CT plus real rTMS or CT plus placebo rTMS. The results showed that the improvement in the trained associative memory induced with rTMS was superior to that obtained with CT alone. Interestingly, the extent of the additional improvement was affected by disease severity and levels of education, with less impaired and more educated patients showing a greater benefit. When testing for generalization to non-trained cognitive functions, results indicated that patients in CT-real group showed also a greater improvement in visuospatial reasoning than those in the CT-sham group. Interestingly, this improvement persisted over 12 weeks after treatment beginning. The present study provides important hints on the promising therapeutic use of rTMS in AD.",2020,The results showed that the improvement in the trained associative memory induced with rTMS was superior to that obtained with CT alone.,"['Fifty patients from a very early to a moderate phase of dementia', ""Alzheimer's disease""]","['rTMS', 'CT plus real rTMS or CT plus placebo rTMS', 'repetitive transcranial magnetic stimulation (rTMS', 'Cognitive training (CT']","['visuospatial reasoning', 'disease severity and levels of education', 'trained associative memory']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0684328', 'cui_str': 'Reasoning'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}]",50.0,0.0608235,The results showed that the improvement in the trained associative memory induced with rTMS was superior to that obtained with CT alone.,"[{'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Bagattini', 'Affiliation': 'Cognitive Neuroscience Section, IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, 25125, Brescia, Italy. Electronic address: chiara.bagattini@cognitiveneuroscience.it.'}, {'ForeName': 'Mara', 'Initials': 'M', 'LastName': 'Zanni', 'Affiliation': ""Fondazione Europea Ricerca Biomedica, Ospedale Sant'Isidoro, 24069, Trescore Balneario, Bergamo, Italy.""}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Barocco', 'Affiliation': ""Fondazione Europea Ricerca Biomedica, Ospedale Sant'Isidoro, 24069, Trescore Balneario, Bergamo, Italy.""}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Caffarra', 'Affiliation': 'Department of Medicine and Surgery, Section of Neuroscience, University of Parma, 43126, Parma, Italy.'}, {'ForeName': 'Debora', 'Initials': 'D', 'LastName': 'Brignani', 'Affiliation': 'Cognitive Neuroscience Section, IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, 25125, Brescia, Italy.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Miniussi', 'Affiliation': 'Center for Mind/Brain Sciences- CIMeC, University of Trento, 38068, Rovereto, Italy.'}, {'ForeName': 'Carlo Alberto', 'Initials': 'CA', 'LastName': 'Defanti', 'Affiliation': ""Fondazione Europea Ricerca Biomedica, Ospedale Sant'Isidoro, 24069, Trescore Balneario, Bergamo, Italy.""}]",Brain stimulation,['10.1016/j.brs.2020.09.010']
3089,33002684,Positive memory training for the treatment of depression in schizophrenia: A randomised controlled trial.,"BACKGROUND


Around half of people diagnosed with schizophrenia suffer from co-morbid depression, yet there are no evidence-based psychological treatments to target this presentation.
METHOD


Participants were aged 18-65 years old, had a clinical diagnosis of schizophrenia or schizoaffective disorder and at least a mild level of depression. Participants were randomly assigned (1:1) to receive PoMeT or treatment as usual. PoMeT was delivered in up to 12 individual sessions within 3 months. We stratified randomisation by site and by severity of depression using randomised-permuted blocks. Assessments were carried out at baseline, 3-month, 6-month and 9-month by assessors who were blind to treatment allocation. The primary outcome was reduction in the symptoms of depression at 3-month, 6-month and 9-month as measured by the BDI-II. Analysis was by intention-to-treat with linear mixed-effects models. The trial was registered with the ISRCTN registry number 99485756.
RESULTS


One hundred participants were randomly assigned to either PoMeT (n = 49) or treatment as usual (n = 51). The reduction in BDI-II total score at 3 months was significantly greater for PoMeT than for treatment as usual (mean difference = 4.33, SE = 2.00, 95% CI 0.38 to 8.23; p = 0.03).
DISCUSSION


To our knowledge this is, to date, the largest powered randomised controlled trial focused on the psychological treatment of depression in people diagnosed with schizophrenia. Results indicate that a brief targeted intervention can reduce the symptoms of depression in the group. The main limitation of the study is the lack of an active control group which may contribute to an inflated treatment effect.",2020,"The reduction in BDI-II total score at 3 months was significantly greater for PoMeT than for treatment as usual (mean difference = 4.33, SE = 2.00, 95% CI 0.38 to 8.23; p = 0.03).
","['people diagnosed with schizophrenia', 'One hundred participants', 'Participants were aged 18-65 years old, had a clinical diagnosis of schizophrenia or schizoaffective disorder and at least a mild level of depression', 'depression in schizophrenia']","['PoMeT', 'Positive memory training']","['symptoms of depression', 'symptoms of depression at 3-month, 6-month and 9-month as measured by the BDI-II', 'reduction in BDI-II total score']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis'}, {'cui': 'C0036337', 'cui_str': 'Schizoaffective disorder'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C1319226', 'cui_str': 'Level of depression'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0561841', 'cui_str': 'Pleasant memories'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0006448', 'cui_str': 'Burundi'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",100.0,0.285473,"The reduction in BDI-II total score at 3 months was significantly greater for PoMeT than for treatment as usual (mean difference = 4.33, SE = 2.00, 95% CI 0.38 to 8.23; p = 0.03).
","[{'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Steel', 'Affiliation': 'Oxford Health NHS Foundation Trust, Oxford, UK; School of Psychology, University of Reading, UK. Electronic address: craig.steel@hmc.ox.ac.uk.'}, {'ForeName': 'Kees', 'Initials': 'K', 'LastName': 'Korrelboom', 'Affiliation': 'Department of Anxiety Disorders, PsyQ Parnassia Group, Psychiatric Center, The Hague, the Netherlands; Department of Medical and Clinical Psychiatry, Tilburg University, Tilburg, the Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Fazil Baksh', 'Affiliation': 'Department of Mathematics and Statistics, University of Reading, Whiteknights, Reading, RG6 6AL, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kingdon', 'Affiliation': 'University of Southampton, Highfield, Southampton, SO17 1BJ, UK.'}, {'ForeName': 'Judit', 'Initials': 'J', 'LastName': 'Simon', 'Affiliation': 'Department of Health Economics, Center for Public Health, Medical University of Vienna, 1090, Wien, Kinderspitalgasse 15, Austria; Department of Psychiatry, University of Oxford and Oxford Health NHS Trust, Warneford Hospital, Oxford OX3 7JX, UK.'}, {'ForeName': 'Til', 'Initials': 'T', 'LastName': 'Wykes', 'Affiliation': 'Department of Psychology, Institute of Psychiatry, Psychology & Neuroscience, London, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Phiri', 'Affiliation': 'Southern Health NHS Foundation Trust, Research & Development Department, Tom Rudd Unit, Moorgreen Hospital, Botley Rd, West End Southampton, SO30 3JB, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'van der Gaag', 'Affiliation': 'VU University and Amsterdam Public Mental Health Research Institute, Department of Clinical Psychology Van der Boechorststraat 1, 1081, BT, Amsterdam, the Netherlands; Parnassia Psychiatric Institute, Zoutkeetsingel 40, 2512, HN, The Hague, the Netherlands.'}]",Behaviour research and therapy,['10.1016/j.brat.2020.103734']
3090,33002685,Collaborative care for depression in older adults: How much is enough?,"Collaborative care in primary care has been shown to be effective for subthreshold depression in older adults in the 'CASPER' trial. However, to understand the impact of adherence, and to explore the minimum effective dose of collaborative care, we reanalysed the trial data using a complier average causal effect (CACE) analysis. Data were available for 705 participants, 519 with 12-month PHQ-9 scores. 'Compliance' could be observed for participants in the intervention group. Latent complier status in the control group was estimated. Completion of five or more sessions of care was defined as 'compliance'. Sensitivity analyses, using alternative cut-offs of two to eight sessions, assessed the impact of changing the definition of 'compliance'. Compliers in the intervention group had lower PHQ-9 scores at 12-month follow up than assumed compliers in the control group (1.75 lower, 95% confidence interval 0.29 to 3.21, p = 0.02), a greater effect than originally reported. Sensitivity analyses confirmed statistically significant differences between the intervention and control groups in those attending five or more sessions. We conclude that collaborative care is causally effective in reducing subthreshold depressive symptoms in older people who adhere to treatment. Our findings suggest the minimum effective dose is five sessions.",2020,"Compliers in the intervention group had lower PHQ-9 scores at 12-month follow up than assumed compliers in the control group (1.75 lower, 95% confidence interval 0.29 to 3.21, p = 0.02), a greater effect than originally reported.","['older adults', '705 participants, 519 with 12-month PHQ-9 scores. ', 'older people who adhere to treatment']","['collaborative care', 'Collaborative care']","['lower PHQ-9 scores', 'subthreshold depressive symptoms']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",[],"[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",705.0,0.060507,"Compliers in the intervention group had lower PHQ-9 scores at 12-month follow up than assumed compliers in the control group (1.75 lower, 95% confidence interval 0.29 to 3.21, p = 0.02), a greater effect than originally reported.","[{'ForeName': 'Toby', 'Initials': 'T', 'LastName': 'Bonvoisin', 'Affiliation': 'Department of Health Sciences, University of York, Heslington, YO10 5DD, UK; Hull University Teaching Hospitals NHS Trust, Hull, HU3 2JZ, UK. Electronic address: ttb508@york.ac.uk.'}, {'ForeName': 'Lewis W', 'Initials': 'LW', 'LastName': 'Paton', 'Affiliation': 'Department of Health Sciences, University of York, Heslington, YO10 5DD, UK. Electronic address: lewis.paton@york.ac.uk.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Hewitt', 'Affiliation': 'Department of Health Sciences, University of York, Heslington, YO10 5DD, UK. Electronic address: catherine.hewitt@york.ac.uk.'}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'McMillan', 'Affiliation': 'Department of Health Sciences, University of York, Heslington, YO10 5DD, UK; Hull York Medical School, University of York, Heslington, YO10 5DD, UK. Electronic address: dean.mcmillan@york.ac.uk.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Gilbody', 'Affiliation': 'Department of Health Sciences, University of York, Heslington, YO10 5DD, UK; Hull York Medical School, University of York, Heslington, YO10 5DD, UK. Electronic address: simon.gilbody@york.ac.uk.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Tiffin', 'Affiliation': 'Department of Health Sciences, University of York, Heslington, YO10 5DD, UK; Hull York Medical School, University of York, Heslington, YO10 5DD, UK. Electronic address: paul.tiffin@york.ac.uk.'}]",Behaviour research and therapy,['10.1016/j.brat.2020.103725']
3091,33004457,Genome Sequences of Gordonia rubripertincta Bacteriophages Jellybones and NHagos.,"Jellybones and NHagos are bacteriophages that were identified in the host bacterium  Gordonia rubripertincta  NRRL B-16540. Jellybones has a direct terminal repeat and was assigned to the CS2 subcluster with a length of 77,514 bp. NHagos is circularly permuted and was assigned to the DR cluster with a length of 59,580 bp.",2020,Jellybones and NHagos are bacteriophages that were identified in the host bacterium  Gordonia rubripertincta  NRRL B-16540.,[],[],[],[],[],[],,0.0237935,Jellybones and NHagos are bacteriophages that were identified in the host bacterium  Gordonia rubripertincta  NRRL B-16540.,"[{'ForeName': ""D'Andrew L"", 'Initials': 'DL', 'LastName': 'Harrington', 'Affiliation': 'Department of Biology, College of Southern Nevada, Las Vegas, Nevada, USA.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Stevens', 'Affiliation': 'Department of Biology, College of Southern Nevada, Las Vegas, Nevada, USA.'}, {'ForeName': 'Mia J', 'Initials': 'MJ', 'LastName': 'Johnson', 'Affiliation': 'Department of Biology, College of Southern Nevada, Las Vegas, Nevada, USA.'}, {'ForeName': 'Samantha J', 'Initials': 'SJ', 'LastName': 'Pochiro', 'Affiliation': 'Department of Biology, College of Southern Nevada, Las Vegas, Nevada, USA.'}, {'ForeName': 'Michelle M', 'Initials': 'MM', 'LastName': 'Moriarty', 'Affiliation': 'Department of Biology, College of Southern Nevada, Las Vegas, Nevada, USA.'}, {'ForeName': 'Miriam E', 'Initials': 'ME', 'LastName': 'Robertson', 'Affiliation': 'Department of Biology, College of Southern Nevada, Las Vegas, Nevada, USA.'}, {'ForeName': 'Andy', 'Initials': 'A', 'LastName': 'Sanchez', 'Affiliation': 'Department of Biology, College of Southern Nevada, Las Vegas, Nevada, USA.'}, {'ForeName': 'Orin G', 'Initials': 'OG', 'LastName': 'Whitby', 'Affiliation': 'Department of Biology, College of Southern Nevada, Las Vegas, Nevada, USA.'}, {'ForeName': 'Kendra W', 'Initials': 'KW', 'LastName': 'Kimberley', 'Affiliation': 'Department of Biology, College of Southern Nevada, Las Vegas, Nevada, USA.'}, {'ForeName': 'Chelsey C', 'Initials': 'CC', 'LastName': 'McKenna', 'Affiliation': 'Department of Biology, College of Southern Nevada, Las Vegas, Nevada, USA.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Theoret', 'Affiliation': 'Department of Biology, College of Southern Nevada, Las Vegas, Nevada, USA.'}, {'ForeName': 'Erin J', 'Initials': 'EJ', 'LastName': 'Windsor', 'Affiliation': 'Department of Biology, College of Southern Nevada, Las Vegas, Nevada, USA.'}, {'ForeName': 'Earl J', 'Initials': 'EJ', 'LastName': 'Yoon', 'Affiliation': 'Department of Biology, College of Southern Nevada, Las Vegas, Nevada, USA earl.yoon@csn.edu.'}]",Microbiology resource announcements,['10.1128/MRA.00935-20']
3092,33004790,"Acute effects of whey protein on energy intake, appetite and gastric emptying in younger and older, obese men.","BACKGROUND


Obesity is becoming more prevalent in older people. A management strategy in obese, young adults is to increase dietary protein relative to other macronutrients. It is not clear if this is effective in obese, older individuals. Obesity may be associated with diminished sensitivity to nutrients. We have reported that a 30-g whey protein drink slows gastric emptying more, and suppresses energy intake less, in older, than younger, non-obese men. The aim of this study was to determine the effect of a 30 g whey protein drink on energy intake, GE and glycaemia in obese, older and younger men.
METHODS


In randomized, double-blind order, 10 younger (age: 27 ± 2 years; BMI: 36 ± 2 kg/m²), and 10 older (72 ± 1 years; 33 ± 1 kg/m²), obese men were studied twice. After an overnight fast, subjects ingested a test drink containing 30 g whey protein (120 kcal) or control (2 kcal). Postprandial gastric emptying (antral area, 2D Ultrasound) and blood glucose concentrations were measured for 180 min. At t = 180 min subjects were given a buffet meal and ad libitum energy intake was assessed.
RESULTS


Older subjects ate non-significantly less (~20%) that the younger subjects (effect of age, P = 0.16). Whey protein had no effect on subsequent energy intake (kcal) compared to control in either the younger (decrease 3 ± 8%) or older (decrease 2 ± 8%) obese men (age effect P > 0.05, protein effect P = 0.46, age × protein interaction effect P = 0.84). Whey protein slowed gastric emptying, to a similar degree in both age groups (50% emptying time: control vs. protein young men: 255 ± 5 min vs. 40 ± 7 min; older men: 16 ± 5 min vs. 50 ± 8 min; protein effect P = 0.001, age effect P = 0.93, age × protein interaction effect P = 0.13).
CONCLUSIONS


Our data suggest that obesity may blunt/abolish the age-related effect of whey protein on suppression of energy intake.",2020,"Whey protein had no effect on subsequent energy intake (kcal) compared to control in either the younger (decrease 3 ± 8%) or older (decrease 2 ± 8%) obese men (age effect P > 0.05, protein effect P = 0.46, age × protein interaction effect P = 0.84).","['younger and older, obese men', 'older, than younger, non-obese men', 'older people', 'obese, young adults', 'obese, older and younger men', '10 younger (age: 27\u2009±\u20092\u2009years; BMI: 36\u2009±\u20092\u2009kg/m²), and 10 older (72\u2009±\u20091\u2009years; 33\u2009±\u20091\u2009kg/m²), obese men', 'obese, older individuals']","['whey protein', '30\u2009g whey protein drink']","['subsequent energy intake (kcal', 'energy intake, GE and glycaemia', 'Postprandial gastric emptying (antral area, 2D Ultrasound) and blood glucose concentrations', 'gastric emptying', 'energy intake, appetite and gastric emptying']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0452428', 'cui_str': 'Drink'}]","[{'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0017127', 'cui_str': 'Gastric emptying'}, {'cui': 'C0293352', 'cui_str': 'Antral'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C2585282', 'cui_str': 'Blood glucose concentration'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}]",,0.0726594,"Whey protein had no effect on subsequent energy intake (kcal) compared to control in either the younger (decrease 3 ± 8%) or older (decrease 2 ± 8%) obese men (age effect P > 0.05, protein effect P = 0.46, age × protein interaction effect P = 0.84).","[{'ForeName': 'Avneet', 'Initials': 'A', 'LastName': 'Oberoi', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence in Translating Nutritional Science to Good Health, The University of Adelaide, Adelaide, Royal Adelaide Hospital, South-Australia, SA, Australia.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Giezenaar', 'Affiliation': 'Riddet Institute, Massey University, Palmerston North, New Zealand.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Jensen', 'Affiliation': 'Centre for Nutrition, Department of Clinical Medicine, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Kylie', 'Initials': 'K', 'LastName': 'Lange', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence in Translating Nutritional Science to Good Health, The University of Adelaide, Adelaide, Royal Adelaide Hospital, South-Australia, SA, Australia.'}, {'ForeName': 'Trygve', 'Initials': 'T', 'LastName': 'Hausken', 'Affiliation': 'Department of Medicine, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Jones', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence in Translating Nutritional Science to Good Health, The University of Adelaide, Adelaide, Royal Adelaide Hospital, South-Australia, SA, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Horowitz', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence in Translating Nutritional Science to Good Health, The University of Adelaide, Adelaide, Royal Adelaide Hospital, South-Australia, SA, Australia.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Chapman', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence in Translating Nutritional Science to Good Health, The University of Adelaide, Adelaide, Royal Adelaide Hospital, South-Australia, SA, Australia.'}, {'ForeName': 'Stijn', 'Initials': 'S', 'LastName': 'Soenen', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence in Translating Nutritional Science to Good Health, The University of Adelaide, Adelaide, Royal Adelaide Hospital, South-Australia, SA, Australia. stijn.soenen@adelaide.edu.au.'}]",Nutrition & diabetes,['10.1038/s41387-020-00139-8']
3093,33006562,An Interactive Text Messaging Intervention to Improve Adherence to Option B+ Prevention of Mother-to-Child HIV Transmission in Kenya: Cost Analysis.,"BACKGROUND


Mobile health (mHealth) approaches offer potentially affordable ways to support the care of HIV-infected patients in overstretched health care systems. However, only few studies have analyzed the costs associated with mHealth solutions for HIV care.
OBJECTIVE


The aim of this study was to estimate the total incremental costs and incremental cost per beneficiary of an interactive SMS text messaging support intervention within a clinical trial.
METHODS


The Mobile WAChX trial (NCT02400671) evaluates an interactive semiautomated SMS text messaging intervention to improve adherence to antiretroviral therapy and retention in care among peripartum women infected with HIV in Kenya to reduce the mother-to-child transmission of HIV. Women were randomized to receive one-way versus two-way SMS text messages. Messages were sent weekly, and these messages included motivational and educational content and visit reminders; two-way messaging enabled prompt consultation with the nurse as needed. Microcosting methods were used to collect resource-use data related to implementing the Mobile WAChX SMS text messaging intervention. At 2 sites (Nairobi and Western Kenya), we conducted semistructured interviews with health personnel to identify startup and recurrent activities by obtaining information on the personnel, supplies, and equipment. Data on expenditures and prices from project expense reports, administrative records, and published government salary data were included to estimate the total incremental costs. Using a public provider perspective, we estimated incremental unit costs per beneficiary and per contact during 2017.
RESULTS


The weighted average annual incremental costs for the two-way SMS text messaging group were US $3725 per facility, US $62 per beneficiary, and US $0.85 per contact to reach 115 beneficiaries. For the one-way SMS text messaging group, the weighted average annual incremental costs were US $2542 per facility, US $41 per beneficiary, and US $0.66 per contact to reach 117 beneficiaries. The largest cost shares were for the personnel: 48.2% (US $1794/US $3725) in two-way and 32.4% (US $825/US $2542) in one-way SMS text messaging groups. Costs associated with software development and communication accounted for 29.9% (US $1872/US $6267) of the costs in both intervention arms (US $1042 vs US $830, respectively).
CONCLUSIONS


Cost information for budgeting and financial planning is relevant for implementing mHealth interventions in national health plans. Given the proportion of costs related to systems development, it is likely that costs per beneficiary will decline with the scale-up of the interventions.",2020,The largest cost shares were for the personnel: 48.2% (US $1794/US $3725) in two-way and 32.4% (US $825/US $2542) in one-way SMS text messaging groups.,"['Mother-to-Child HIV Transmission in Kenya', 'peripartum women infected with HIV in Kenya to reduce the mother-to-child transmission of HIV']","['interactive semiautomated SMS text messaging intervention', 'Interactive Text Messaging Intervention', 'interactive SMS text messaging support intervention']",[],"[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C2936492', 'cui_str': 'Peripartum Women'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0282474', 'cui_str': 'Infection Transmission, Maternal-Fetal'}]","[{'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0183683', 'cui_str': 'Support'}]",[],,0.0560755,The largest cost shares were for the personnel: 48.2% (US $1794/US $3725) in two-way and 32.4% (US $825/US $2542) in one-way SMS text messaging groups.,"[{'ForeName': 'Yilin', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, United States.'}, {'ForeName': 'Keshet', 'Initials': 'K', 'LastName': 'Ronen', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, United States.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Matemo', 'Affiliation': 'Kenyatta National Hospital, Nairobi, Kenya.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Unger', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, United States.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Kinuthia', 'Affiliation': 'Kenyatta National Hospital, Nairobi, Kenya.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'John-Stewart', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, United States.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Levin', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, United States.'}]",JMIR mHealth and uHealth,['10.2196/18351']
3094,33006904,Glycemic Improvement Using Continuous Glucose Monitoring by Baseline Time in Range: Subgroup Analyses from the DIAMOND Type 1 Diabetes Study.,"The DIAMOND study demonstrated that real-time continuous glucose monitors (rtCGMs) improve glycemia for adults with type 1 diabetes using multiple daily injections. This analysis explores the relationship between baseline time in range (TIR) and improvement in TIR using rtCGMs or self-monitoring of blood glucose (SMBG). Baseline TIR was divided into three categories: <40% (9.6 h per day), <50% (12 h per day), and <60% (14.4 h per day). Compared with SMBG, use of rtCGMs increased mean TIR by an additional 16 min per day for participants with a baseline TIR <40%, 77 min per day for baseline TIR <50%, and 88 min per day for baseline TIR <60%. A greater percentage of participants increased TIR by >4 h per day using rtCGMs within the three baseline TIR groups. For participants with a baseline TIR <50%, 29% of rtCGM users improved their TIR by >4 h per day compared with no SMBG users ( P  < 0.001). Similar trends were found for improvement in mean glucose and time spent in hyper- and hypoglycemic ranges.",2020,A greater percentage of participants increased TIR by >4 h/day using rtCGM within the three baseline TIR groups.,['adults with T1D using multiple daily injections'],"['real-time continuous glucose monitors (rtCGM', 'rtCGM']","['mean glucose and time spent in hyper- and hypoglycemic ranges', 'baseline time in range (TIR) and improvement in TIR using rtCGM or self-monitoring of blood glucose (SMBG', 'Glycemic Improvement', 'mean TIR']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C4523945', 'cui_str': 'Continuous glucose monitoring'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0460094', 'cui_str': 'Within reference range'}, {'cui': 'C4523945', 'cui_str': 'Continuous glucose monitoring'}, {'cui': 'C0005803', 'cui_str': 'Self-monitoring of blood glucose'}]",,0.085825,A greater percentage of participants increased TIR by >4 h/day using rtCGM within the three baseline TIR groups.,"[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Calhoun', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Price', 'Affiliation': 'Dexcom, Inc., San Diego, California, USA.'}, {'ForeName': 'Roy W', 'Initials': 'RW', 'LastName': 'Beck', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida, USA.'}]",Diabetes technology & therapeutics,['10.1089/dia.2020.0471']
3095,32680912,Impact of Improved Biomass and Liquid Petroleum Gas Stoves on Birth Outcomes in Rural Nepal: Results of 2 Randomized Trials.,"BACKGROUND


Few randomized trials have assessed the impact of reducing household air pollution from biomass stoves on adverse birth outcomes in low-income countries.
METHODS


Two sequential trials were conducted in rural low-lying Nepal. Trial 1 was a cluster-randomized step-wedge trial comparing traditional biomass stoves and improved biomass stoves vented with a chimney. Trial 2 was a parallel household-randomized trial comparing vented biomass stoves and liquid petroleum gas (LPG) stoves with a year's supply of gas. Kitchen particulate matter of 2.5 μm or less (PM 2.5 ) and carbon monoxide (CO) were assessed before and after stove installation. Prevalent and incident pregnancies were enrolled at baseline and throughout the trials. Birth anthropometry was compared across differing exposure times in pregnancy.
RESULTS


In trial 1, the mean 20-hour kitchen PM 2.5  concentration was reduced from 1380 µg/m 3  to 936 µg/m 3 . Among infants born before the intervention, mean birth weight and gestational age were 2627 g (SD=443) and 38.8 weeks (SD=3.1), and 39% were low birth weight (LBW), 22% preterm, and 55% small for gestational age (SGA). Adverse birth outcomes were not significantly different with increasing exposure to improved stoves during pregnancy. In trial 2, the mean 20-hour PM 2.5  concentration was 885 µg/m 3  in households with vented biomass and 442 µg/m 3  in those with LPG stoves. Mean birth weight was 2780 g (SD=427) and 2742 g (SD=431), among households with vented and LPG stoves, respectively. Respective percentages for LBW, SGA, and preterm were 23%, 13%, and 42% in the vented stove group and not statistically different from 31%, 17%, and 42% in the LPG group.
CONCLUSIONS


Improved biomass or LPG stoves did not reduce adverse birth outcomes. PM 2.5  and CO following improved stove installation remained well above the World Health Organization indoor air standard of 25 µg/m 3  or intermediate air quality guideline of 37.5 µg/m 3 . Trials that lower indoor air pollution further are needed.",2020,PM 2.5  and CO following improved stove installation remained well above the World Health Organization indoor air standard of 25 µg/m 3  or intermediate air quality guideline of 37.5 µg/m 3 .,"['Two sequential trials were conducted in rural low-lying Nepal', 'infants born before the intervention, mean birth weight and gestational age were 2627 g (SD=443) and 38.8 weeks (SD=3.1), and 39% were low birth weight (LBW), 22% preterm, and 55% small for gestational age (SGA', 'low-income countries', 'Rural Nepal']","['household air pollution from biomass stoves', 'traditional biomass stoves and improved biomass stoves vented with a chimney', 'Improved Biomass and Liquid Petroleum Gas Stoves', ""vented biomass stoves and liquid petroleum gas (LPG) stoves with a year's supply of gas""]","['adverse birth outcomes', 'LBW, SGA, and preterm', 'Mean birth weight', 'mean 20-hour kitchen PM 2.5  concentration', 'carbon monoxide (CO', 'Adverse birth outcomes']","[{'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0023668', 'cui_str': 'Liechtenstein'}, {'cui': 'C0027689', 'cui_str': 'Nepal'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0024032', 'cui_str': 'Low Birth Weights'}, {'cui': 'C0235991', 'cui_str': 'Small for gestational age'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0454664', 'cui_str': 'Country'}]","[{'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0001873', 'cui_str': 'Air pollution'}, {'cui': 'C0005535', 'cui_str': 'Biomass'}, {'cui': 'C0336754', 'cui_str': 'Stove'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0557689', 'cui_str': 'Chimney'}, {'cui': 'C3463996', 'cui_str': 'Liquid Petroleum'}, {'cui': 'C1268549', 'cui_str': 'Gas stove'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}]","[{'cui': 'C1286282', 'cui_str': 'Birth outcome'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0557653', 'cui_str': 'Kitchen'}, {'cui': 'C1720884', 'cui_str': 'Particulate Matter'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}]",,0.215707,PM 2.5  and CO following improved stove installation remained well above the World Health Organization indoor air standard of 25 µg/m 3  or intermediate air quality guideline of 37.5 µg/m 3 .,"[{'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Katz', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA. jkatz1@jhu.edu.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Tielsch', 'Affiliation': 'Department of Global Health, Milken Institute School of Public Health, George Washington University, Washington, DC, USA.'}, {'ForeName': 'Subarna K', 'Initials': 'SK', 'LastName': 'Khatry', 'Affiliation': 'Nepal Nutrition Intervention Project, Sarlahi, Kathmandu, Nepal.'}, {'ForeName': 'Laxman', 'Initials': 'L', 'LastName': 'Shrestha', 'Affiliation': 'Institute of Medicine, Tribhuvan University, Kathmandu, Nepal.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Breysse', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Scott L', 'Initials': 'SL', 'LastName': 'Zeger', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Naoko', 'Initials': 'N', 'LastName': 'Kozuki', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Checkley', 'Affiliation': 'Department of Medicine, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Steven C', 'Initials': 'SC', 'LastName': 'LeClerq', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Luke C', 'Initials': 'LC', 'LastName': 'Mullany', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}]","Global health, science and practice",['10.9745/GHSP-D-20-00011']
3096,33010473,Patient navigation among recently hospitalized smokers to promote tobacco treatment: Results from a randomized exploratory pilot study.,"INTRODUCTION


Adding screening for health-related social needs to tobacco treatment interventions initiated during hospitalizations may improve intervention effectiveness among vulnerable populations. Our objective was to examine the effect the acceptability and feasibility of a intervention in which a patient navigator screens for and addresses social needs to increase receipt of smoking cessation medication among recently hospitalized smokers at a safety-net hospital.
METHODS


In a two-group randomized exploratory pilot study, we assigned hospitalized smokers to either the Enhanced Traditional Control (ETC) group (list of smoking cessation resources) or ETC + Patient Navigation (up to 10 h of navigation over a 3-month period, in which a navigator screens for and addresses health-related social needs). We assessed socio-demographics, smoking-related variables, and process data.
RESULTS


Of 171 individuals screened, 44 (26%) were enrolled. Participants (mean age = 54.9 years, 61.4% non-Hispanic black, 68.2% high school education or less) smoked a mean of 11.4 cigarettes/day. 20 participants received a prescription for a cessation medication, 42.9% in the ETC group and 47.8% in the ETC + Patient Navigation group. 11 participants (47.8%) in the ETC + Patient Navigation group received the minimum intervention dose (completion of the social needs screener and at least one counseling session). Barriers to navigation were participants' medical illness and difficulty connecting with participants.
CONCLUSIONS


Although nearly half of hospitalized smokers receiving support from a patient navigator received a prescription for a smoking cessation medication, the percentage did not differ by study arm. Refinement of the protocol to coordinate with hospital-wide tobacco treatment and social needs screening initiatives is needed.",2020,"20 participants received a prescription for a cessation medication, 42.9% in the ETC group and 47.8% in the ETC + Patient Navigation group.","['54.9\xa0years, 61.4% non-Hispanic black, 68.2% high school education or less) smoked a mean of 11.4 cigarettes/day', 'Participants (mean age\xa0', '20 participants', 'Of 171 individuals screened, 44 (26%) were enrolled']","['ETC\xa0+\xa0Patient Navigation group', 'minimum intervention dose (completion of the social needs screener and at least one counseling session', 'Enhanced Traditional Control (ETC) group (list of smoking cessation resources) or ETC\xa0+\xa0Patient Navigation (up to 10\xa0h of navigation']",[],"[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0455002', 'cui_str': 'Education and schooling detail'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517533', 'cui_str': '11.4'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3494323', 'cui_str': 'Patient Navigation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0547043', 'cui_str': 'Up'}]",[],,0.0505863,"20 participants received a prescription for a cessation medication, 42.9% in the ETC group and 47.8% in the ETC + Patient Navigation group.","[{'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Quintiliani', 'Affiliation': 'Boston University, School of Medicine, Boston Medical Center, Section of General Internal Medicine, 801 Massachusetts Ave., Crosstown 2, Boston, MA 02118, United States. Electronic address: Lmquinti@bu.edu.'}, {'ForeName': 'Hasmeena', 'Initials': 'H', 'LastName': 'Kathuria', 'Affiliation': 'Boston University, School of Medicine, The Pulmonary Center, Boston Medical Center, Section of Pulmonary, Allergy, Sleep & Critical Care Medicine, 72 East Concord St., Boston, MA 02118, United States.'}, {'ForeName': 'Ve', 'Initials': 'V', 'LastName': 'Truong', 'Affiliation': 'Boston Medical Center, Section of General Internal Medicine, 801 Massachusetts Ave., Crosstown 2, Boston, MA 02118, United States.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Murillo', 'Affiliation': 'Boston Medical Center, Section of General Internal Medicine, 801 Massachusetts Ave., Crosstown 2, Boston, MA 02118, United States.'}, {'ForeName': 'Belinda', 'Initials': 'B', 'LastName': 'Borrelli', 'Affiliation': 'Boston University, Henry M. Goldman School of Dental Medicine, Center for Behavioral Science Research, 560 Harrison Ave., Boston, MA 02118, United States.'}, {'ForeName': 'Ziming', 'Initials': 'Z', 'LastName': 'Xuan', 'Affiliation': 'Boston University, School of Public Health, 801 Massachusetts Ave., Crosstown CT453, Boston, MA 02118, United States.'}, {'ForeName': 'Karen E', 'Initials': 'KE', 'LastName': 'Lasser', 'Affiliation': 'Boston University, School of Medicine, Boston Medical Center, Section of General Internal Medicine, 801 Massachusetts Ave., Crosstown 2, Boston, MA 02118, United States.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106659']
3097,33010491,The incidence of persistent postoperative opioid use among U.S. veterans: A national study to identify risk factors.,"OBJECTIVE


To calculate the incidence and identify the predictors of persistent postoperative opioid use at different postoperative days.
BACKGROUND DATA


A subset of surgical patients continues to use long-term opioids. The importance of the risk factors at different postoperative days is not known.
DESIGN


A historical cohort.
SETTING


Postoperative period.
PATIENTS


Opioid-naive U.S. veterans.
INTERVENTIONS


The surgical group had any one of 19 common invasive procedures. The control group is a 10% random sample. Each control was randomly assigned a surgery date.
MEASUREMENTS


The outcomes were the presence of persistent opioid use as determined by continued filling of prescriptions for opioids on postoperative days 90, 180, 270, and 365.
MAIN RESULTS


A total of 183,430 distinct surgical cases and 1,318,894 controls were identified. 1.0% of the surgical patients were using opioids at 90 days, 0.6% at 180 days, 0.4% at 270 days, and 0.1% at 365 days after the surgery. Surgery was strongly associated with postoperative persistent opioid use at day 90 (OR 3.67, 95% CI, 3.43-3.94, p < 0.001), at day 180 (OR 2.85, 2.67-3.12, p < 0.001), at day 270 (OR 2.63, 2.38-2.91, p < 0.001) and at day 365 (OR 2.11, 1.77-2.51, p < 0.001) compared to non-surgical controls. In risk factor analysis, being male and single were associated with persistent opioid use at earlier time points (90 and 180 days), while hepatitis C and preoperative benzodiazepine use were associated with persistent opioid use at later time points (270 and 365 days).
CONCLUSIONS


Many surgeries or invasive procedures are associated with an increased risk of persistent postoperative opioid use. The postoperative period is dynamic and the risk factors change with time.",2020,"Surgery was strongly associated with postoperative persistent opioid use at day 90 (OR 3.67, 95% CI, 3.43-3.94, p < 0.001), at day 180 (OR 2.85, 2.67-3.12, p < 0.001), at day 270 (OR 2.63, 2.38-2.91, p < 0.001) and at day 365 (OR 2.11, 1.77-2.51, p < 0.001) compared to non-surgical controls.","['Opioid-naive U.S. veterans', 'U.S. veterans', '183,430 distinct surgical cases and 1,318,894 controls were identified']",[],['postoperative persistent opioid use'],"[{'cui': 'C1739422', 'cui_str': 'Opioid naive'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205396', 'cui_str': 'Identified'}]",[],"[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",183430.0,0.0682083,"Surgery was strongly associated with postoperative persistent opioid use at day 90 (OR 3.67, 95% CI, 3.43-3.94, p < 0.001), at day 180 (OR 2.85, 2.67-3.12, p < 0.001), at day 270 (OR 2.63, 2.38-2.91, p < 0.001) and at day 365 (OR 2.11, 1.77-2.51, p < 0.001) compared to non-surgical controls.","[{'ForeName': 'Khodadad', 'Initials': 'K', 'LastName': 'Namiranian', 'Affiliation': 'VA Maryland Health Care System, Baltimore, MD, United States of America; Department of Anesthesiology, University of Maryland, Baltimore, MD, United States of America; VA Central California Health Care System, Fresno, CA, United States of America. Electronic address: khodadad.x.namiranian@kp.org.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Siglin', 'Affiliation': 'School of Medicine, University of Maryland, Baltimore, MD, United States of America.'}, {'ForeName': 'John David', 'Initials': 'JD', 'LastName': 'Sorkin', 'Affiliation': 'VA Maryland Health Care System, Baltimore, MD, United States of America; Baltimore VA Medical Center Geriatric Research, Education and Clinical Center, VA Maryland Health Care System, Baltimore, MD, United States of America; Division of Gerontology and Geriatric Medicine, University of Maryland, Baltimore, MD, United States of America.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.110079']
3098,33010590,Plantar pressure distribution and wearing characteristics of three forefoot offloading shoes in healthy adult subjects.,"Forefoot offloading shoes are used to reduce pressure on specific regions of the foot. Aim of the pressure reduction is to aid healing of the soft and bony tissues and prevent complications by treating foot disorders. A great variety of forefoot offloading shoes are available. In a first step to investigate the appropriate use of these footwear in orthopedic settings, we studied plantar pressure distribution and wearing characteristics of three forefoot offloading shoes namely the Mailand, OrthoWedge and Podalux in a healthy population. Twenty subjects walked in a randomized order wearing three forefoot offloading shoes and a reference shoe for six minutes. The Pedar system was used to measure the pressure in 7 regions. Peak pressure and pressure time integral were analyzed as measures of pressure distribution. Furthermore, wearing characteristics were addressed using a Numeric Rating Scale. Pressure distribution and wearing characteristics of the forefoot offloading shoes were compared to a reference shoe. The Mailand and OrthoWedge shoes significantly reduced peak pressure with more than 80% under the hallux and more than 45% under MTH1 (p<.001). The Podalux did not show significant peak pressure reduction under the forefoot compared to the reference shoe. Under the lesser toes, the MTH4-5 region and heel region the Podalux shoe showed even a significant increase in peak pressure (p=.001). Looking at wearing characteristics, the Podalux and reference shoe scored significantly better than the other two forefoot offloading shoes (p<.01). In this study the differences between different forefoot offloading shoes was assessed. The Mailand and OrthoWedge shoes gave the best pressure reduction in the forefoot but are less comfortable in use. The Podalux rocker shoe showed opposite results. Next step is a patient study to compare our results in a patient population.",2020,"Looking at wearing characteristics, the Podalux and reference shoe scored significantly better than the other two forefoot offloading shoes (p<.01).","['Twenty subjects walked', 'healthy adult subjects']",[],"['Numeric Rating Scale. Pressure distribution and wearing characteristics of the forefoot offloading shoes', 'Plantar pressure distribution and wearing characteristics', 'Peak pressure and pressure time integral', 'peak pressure reduction', 'peak pressure']","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]",[],"[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C1510667', 'cui_str': 'Forefoot region of foot'}, {'cui': 'C0036988', 'cui_str': 'Shoes'}, {'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}, {'cui': 'C0445174', 'cui_str': 'Peak pressure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0443238', 'cui_str': 'Integral'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",20.0,0.0330946,"Looking at wearing characteristics, the Podalux and reference shoe scored significantly better than the other two forefoot offloading shoes (p<.01).","[{'ForeName': 'M C H W', 'Initials': 'MCHW', 'LastName': 'Fuchs', 'Affiliation': 'Department of Orthopaedic Surgery, Catharina Hospital Eindhoven, Postbus 1350, 5602 ZA Eindhoven, The Netherlands; Orthopaedic Center Máxima, Máxima Medical Center, Postbus 90052, 5600 PD Eindhoven, The Netherlands. Electronic address: thijn.fuchs@catharinaziekenhuis.nl.'}, {'ForeName': 'M M N', 'Initials': 'MMN', 'LastName': 'Hermans', 'Affiliation': 'Orthopaedic Center Máxima, Máxima Medical Center, Postbus 90052, 5600 PD Eindhoven, The Netherlands.'}, {'ForeName': 'H J J', 'Initials': 'HJJ', 'LastName': 'Kars', 'Affiliation': 'Fontys Hogeschool Eindhoven, Allied Health Professions, Dominee Theodor Fliednerstraat 2, 5631 BN Eindhoven, The Netherlands.'}, {'ForeName': 'J G E', 'Initials': 'JGE', 'LastName': 'Hendriks', 'Affiliation': 'Department of Orthopaedic Surgery, Catharina Hospital Eindhoven, Postbus 1350, 5602 ZA Eindhoven, The Netherlands; Orthopaedic Center Máxima, Máxima Medical Center, Postbus 90052, 5600 PD Eindhoven, The Netherlands.'}, {'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'van der Steen', 'Affiliation': 'Department of Orthopaedic Surgery, Catharina Hospital Eindhoven, Postbus 1350, 5602 ZA Eindhoven, The Netherlands; Orthopaedic Center Máxima, Máxima Medical Center, Postbus 90052, 5600 PD Eindhoven, The Netherlands.'}]","Foot (Edinburgh, Scotland)",['10.1016/j.foot.2020.101744']
3099,33010649,"The effect of a stress ball on stress, vital signs and patient comfort in hemodialysis patients: A randomized controlled trial.","OBJECTIVE


In this study, an investigation was made of the effect of the use of a stress ball, a method of distraction-attracting the attention elsewhere - on stress, vital signs andcomfort levels in hemodialysis patients.
METHODS


This randomized, controlled experimental study, between July 2019 and September 2019 was carried out in a dialysis unit in the inner regions of Turkey. The study was conducted with 45 patients (23 experiments, 22 controls) who were receiving hemodialysis treatment. The experimental group were asked to squeeze a stress ball for approximately 10-15 min throughout eight successive dialysis sessions. The data were obtained with an Individual Description Form, the Distress Thermometer and the Hemodialysis Comfort Scale.
RESULTS


At the end of the study, no significant difference was found in the vital signs and comfort levels of the experimental and control groups (p > 0.05). However, while the stress score of the experimental group decreased significantly, the stress score of the control groups increased (p < 0.05).
CONCLUSION


This study shows that although the use of the stress ball did not affect vital signs and comfort in hemodialysis patients, it had a positive effect on stress.",2020,"At the end of the study, no significant difference was found in the vital signs and comfort levels of the experimental and control groups (p > 0.05).","['45 patients (23 experiments, 22 controls) who were receiving hemodialysis treatment', 'hemodialysis patients', 'between July 2019 and September 2019 was carried out in a dialysis unit in the inner regions of Turkey']",[],"['stress score', 'vital signs and comfort levels', 'stress, vital signs and patient comfort']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C1629858', 'cui_str': 'Dialysis unit'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0041400', 'cui_str': 'Turkey - country'}]",[],"[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0517225', 'cui_str': 'Comfort level'}, {'cui': 'C4277744', 'cui_str': 'Patient Comfort'}]",,0.0236922,"At the end of the study, no significant difference was found in the vital signs and comfort levels of the experimental and control groups (p > 0.05).","[{'ForeName': 'Kadriye Sayin', 'Initials': 'KS', 'LastName': 'Kasar', 'Affiliation': 'Department of Nursing, Faculty of Health Sciences, Aksaray University, Aksaray, Turkey. Electronic address: kadriyekasar@aksaray.edu.tr.'}, {'ForeName': 'Saadet', 'Initials': 'S', 'LastName': 'Erzincanli', 'Affiliation': 'Department of Nursing, Faculty of Health Sciences, Aksaray University, Aksaray, Turkey. Electronic address: saadeterzincanli@hotmail.com.'}, {'ForeName': 'Nesat Tolga', 'Initials': 'NT', 'LastName': 'Akbas', 'Affiliation': 'Dialysis Unit, Training and Research Hospital, Aksaray University, Aksaray, Turkey. Electronic address: takbas@gmail.com.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101243']
3100,33023877,Effect of a real-time feedback smartphone application (TCPRLink) on the quality of telephone-assisted CPR performed by trained laypeople in China: a manikin-based randomised controlled study.,"OBJECTIVES


To determine the effect of a free smartphone application (TCPRLink) that provides real-time monitoring and audiovisual feedback on chest compressions (CC) on trained layperson telephone-assisted cardiopulmonary resuscitation (T-CPR) performance.
DESIGN


A manikin-based randomised controlled study.
SETTING


This study was conducted at a multidisciplinary university and a community centre in China.
PARTICIPANTS


One hundred and eighty-six adult participants (age 18-65 years) with T-CPR training experience were randomly assigned to the TCPRLink (n=94) and T-CPR (n=92) groups with age stratification.
INTERVENTIONS


We compared the participants' performance for 6 min of CC in a simulated T-CPR scenario both at the baseline and after 3 months.
PRIMARY AND SECONDARY OUTCOME MEASURES


The primary outcomes were the CC rate and proportion of adequate CC rate (100-120 min -1 ). The secondary outcomes included the proportion of participants counting the CC rhythm, time to first CC, CC depth, hands-off time and CC full-release ratio.
RESULTS


Participants in the TCPRLink feedback group more consistently performed CC with higher rate, both initially and 3 months later (median 111 (IQR 109-113) vs 108 (103-112) min -1 , p=0.002 and 111 (109-113) vs 108 (105-112) min -1 , p<0.001, respectively), with less need to count the rhythm (21.3% vs 41.3%, p=0.003% and 7% vs 22.6%, p=0.004, respectively) compared with the T-CPR group. There were no significant differences in time to the first CC, hands-off time or CC full-release ratio. Among 55-65 year group, the CC depth was deeper in the TCPRLink group than in the TCPR group (47.1±9.6 vs 38.5±8.7 mm, p=0.001 and 44.7±10.1 vs 39.3±10.8 mm, p=0.07, respectively).
CONCLUSIONS


The TCPRLink application improved T-CPR quality in trained laypersons to provide more effective CCs and lighten the load of counting out the CC with the dispatcher in a simulated T-CPR scenario. Further investigations are required to confirm this effectiveness in real-life resuscitation attempts.",2020,"RESULTS


Participants in the TCPRLink feedback group more consistently performed CC with higher rate, both initially and 3 months later (median 111 (IQR 109-113) vs 108 (103-112) min -1 , p=0.002 and 111 (109-113) vs 108 (105-112) min -1 , p<0.001, respectively), with less need to count the rhythm (21.3% vs 41.3%, p=0.003% and 7% vs 22.6%, p=0.004, respectively) compared with the T-CPR group.","['One hundred and eighty-six adult participants (age 18-65 years) with T-CPR training experience', 'China', 'n=94) and T-CPR (n=92) groups with age stratification', 'This study was conducted at a multidisciplinary university and a community centre in China']","['real-time feedback smartphone application (TCPRLink', 'free smartphone application (TCPRLink', 'TCPRLink feedback', 'TCPRLink', 'trained layperson telephone-assisted cardiopulmonary resuscitation', 'telephone-assisted CPR performed by trained laypeople', 'TCPR']","['CC depth', 'T-CPR quality', 'CC rate and proportion of adequate CC rate', 'time to the first CC, hands-off time or CC full-release ratio', 'proportion of participants counting the CC rhythm, time to first CC, CC depth, hands-off time and CC full-release ratio']","[{'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1290973', 'cui_str': 'Telephone assisted'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C1290973', 'cui_str': 'Telephone assisted'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C1290973', 'cui_str': 'Telephone assisted'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0439157', 'cui_str': 'counts'}]",186.0,0.0599795,"RESULTS


Participants in the TCPRLink feedback group more consistently performed CC with higher rate, both initially and 3 months later (median 111 (IQR 109-113) vs 108 (103-112) min -1 , p=0.002 and 111 (109-113) vs 108 (105-112) min -1 , p<0.001, respectively), with less need to count the rhythm (21.3% vs 41.3%, p=0.003% and 7% vs 22.6%, p=0.004, respectively) compared with the T-CPR group.","[{'ForeName': 'Xuejie', 'Initials': 'X', 'LastName': 'Dong', 'Affiliation': 'School of Public Health, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'School of Public Health, Shanghai Jiao Tong University, Shanghai, China zhanglynn@sjtu.edu.cn.'}, {'ForeName': 'Helge', 'Initials': 'H', 'LastName': 'Myklebust', 'Affiliation': 'Laerdal Medical Cooperation, Stavanger, Norway.'}, {'ForeName': 'Tonje Soraas', 'Initials': 'TS', 'LastName': 'Birkenes', 'Affiliation': 'Laerdal Medical Cooperation, Stavanger, Norway.'}, {'ForeName': 'Zhi-Jie', 'Initials': 'ZJ', 'LastName': 'Zheng', 'Affiliation': 'Department of Global Health, School of Public Health, Peking University, Beijing, China.'}]",BMJ open,['10.1136/bmjopen-2020-038813']
3101,33023898,Long-term metformin adherence in the Diabetes Prevention Program Outcomes Study.,"INTRODUCTION


To investigate long-term metformin adherence in the Diabetes Prevention Program Outcomes Study (DPPOS) by examining: (1) predictors of long-term adherence to study metformin and (2) whether metformin adherence was associated with incident type 2 diabetes.
RESEARCH DESIGN AND METHODS


DPPOS was an open-label continuation of the randomized clinical trial (Diabetes Prevention Program (DPP)) in which eligible participants randomized to the metformin group were offered study metformin and followed over 11 years. A brief structured adherence interview was administered semiannually. Metformin adherence was assessed by pill counts. Predictors of metformin adherence were examined in multivariate regression models. Incident diabetes associated with metformin adherence and other variables was assessed in Cox proportional hazards models.
RESULTS


Of 868 participants eligible to continue taking study metformin, 664 (76%) took at least some metformin over 11 years, with 478 of them reporting problems with adherence. DPPOS cumulative adherence showed significant associations of higher adherence (≥80%) with early adherence at 3 months in DPP (p<0.001) and lower depression scores during DPPOS (p<0.001); significant differences were also seen by race/ethnicity (p<0.004). Predicting adherence by multivariate modeling showed odds of adherence significantly lower for Black participants and for participants reporting more than one barrier. Odds for adherence were significantly higher for those adherent early in DPP and those reporting at least one planned strategy to improve adherence. Higher metformin adherence was significantly associated with a lower diabetes risk (p=0.04), even after adjustment for demographic variables, depression, and anxiety scores.
CONCLUSIONS


In this long-term diabetes prevention study, early metformin adherence and planned strategies to promote adherence improved long-term adherence over 11 years; higher adherence to metformin was related to lower diabetes incidence. Incorporating strategies to promote adherence when initially prescribing metformin and counseling to support adherence over time are warranted.",2020,Odds for adherence were significantly higher for those adherent early in DPP and those reporting at least one planned strategy to improve adherence.,"['868 participants eligible to continue taking study metformin, 664 (76%) took at least some metformin over 11 years, with 478 of them reporting problems with adherence']","['Diabetes Prevention Program (DPP', 'metformin']","['Metformin adherence', 'Odds for adherence', 'lower diabetes risk', 'depression scores', 'demographic variables, depression, and anxiety scores']","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",868.0,0.022693,Odds for adherence were significantly higher for those adherent early in DPP and those reporting at least one planned strategy to improve adherence.,"[{'ForeName': 'Elizabeth Arquin', 'Initials': 'EA', 'LastName': 'Walker', 'Affiliation': 'Medicine, Albert Einstein College of Medicine, Bronx, New York, USA.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Gonzalez', 'Affiliation': 'Medicine, Albert Einstein College of Medicine, Bronx, New York, USA.'}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Tripputi', 'Affiliation': 'The Biostatistics Center, The George Washington University Milken Institute of Public Health, Washington, District of Columbia, USA.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Dagogo-Jack', 'Affiliation': 'Division of Endocrinology, Diabetes & Metabolism General Clinical Research Center, The University of Tennessee Health Science Center, Memphis, Tennessee, USA.'}, {'ForeName': 'Margaret J', 'Initials': 'MJ', 'LastName': 'Matulik', 'Affiliation': 'Medicine, University of Chicago, Chicago, Illinois, USA.'}, {'ForeName': 'Maria G', 'Initials': 'MG', 'LastName': 'Montez', 'Affiliation': 'Medicine, University of Texas Health Sciences Center at San Antonio, San Antonio, Texas, USA.'}, {'ForeName': 'Sameh', 'Initials': 'S', 'LastName': 'Tadros', 'Affiliation': 'Medicine, University of California at Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Sharon L', 'Initials': 'SL', 'LastName': 'Edelstein', 'Affiliation': 'The Biostatistics Center, The George Washington University Milken Institute of Public Health, Washington, District of Columbia, USA dppmail@bsc.gwu.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open diabetes research & care,['10.1136/bmjdrc-2020-001537']
3102,33025645,Comparison of 6-mm and 11-mm dental implants in the posterior region supporting fixed dental prostheses: 5-year results of an open multicenter randomized controlled trial.,"OBJECTIVE


The aim of this multicenter, randomized controlled trial was to compare the clinical and radiographic outcomes of 6-mm or 11-mm implants, placed in the posterior maxilla and mandible, during a 5-year follow-up period.
MATERIALS AND METHODS


Ninety-five patients with adequate bone height for 11-mm implants, were randomly allocated to a 6-mm group (test group with short implants) or an 11-mm group (control group with standard-length implants). Two or three implants of the same length were placed in each patient and after 6 weeks loaded with a splinted provisional restoration. This was followed by definitive splinted restoration 6 months after implant placement. Clinical and radiographic parameters, including the occurrence of complications were recorded.
RESULTS


A total of 49 patients were enrolled to receive 6-mm implants (n = 108) and 46 patients to receive 11-mm implants (n = 101). Three implants (two of 6 mm and one of 11 mm in length) were lost before loading and one 6-mm implant after 15 months of function, and one 11-mm implant was lost during the first year of function. The 5-year survival rates were 96.0% and 98.9% in the 6-mm and 11-mm group, respectively. The mean marginal bone level changes 5 years post-loading were 0.01 ± 0.45 mm (bone gain) in the 6-mm group and -0.12 ± 0.93 mm (bone loss) in the 11-mm group (p = .7670). Clinical parameters, including plaque, bleeding on probing and pocket probing depth were not significantly different between the groups, and also technical complications were low.
CONCLUSION


The clinical and radiographic outcomes of 6-mm short and 11-mm standard-length implants were not different during a 5-year evaluation period.",2020,"Clinical parameters, including plaque, bleeding on probing and pocket probing depth were not significantly different between the groups, and also technical complications were low.
","['49 patients were enrolled to receive 6-mm implants (n\xa0=\xa0108) and 46 patients to receive 11-mm implants (n\xa0=\xa0101', 'Ninety-five patients with adequate bone height for 11-mm implants']","['6-mm group (test group with short implants) or an 11-mm group (control group with standard length implants', '6-mm short and 11-mm standard-length implants']","['technical complications', '5-year survival rates', 'mean marginal bone level changes', 'plaque, bleeding on probing and pocket probing depth']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C4517906', 'cui_str': '95'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1444754', 'cui_str': 'Length'}]","[{'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}]",49.0,0.13408,"Clinical parameters, including plaque, bleeding on probing and pocket probing depth were not significantly different between the groups, and also technical complications were low.
","[{'ForeName': 'Felix L', 'Initials': 'FL', 'LastName': 'Guljé', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Henny J A', 'Initials': 'HJA', 'LastName': 'Meijer', 'Affiliation': 'Department of Oral and Maxillofacial Surgery and Department of Implant Dentistry, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Ingemar', 'Initials': 'I', 'LastName': 'Abrahamsson', 'Affiliation': 'Department of Periodontology, University of Gothenburg, The Sahlgrenska Academy, Gothenburg, Sweden.'}, {'ForeName': 'Christopher A', 'Initials': 'CA', 'LastName': 'Barwacz', 'Affiliation': 'Department of Family Dentistry, University of Iowa College of Dentistry & Dental Clinics, Iowa City, IA, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Department of Periodontics, Melbourne, School of Dental Science, University of Melbourne, Melbourne, Vic., Australia.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Palmer', 'Affiliation': ""King's College London Dental Institute at Guy's King's and St Thomas' Hospitals, London, UK.""}, {'ForeName': 'Homayoun', 'Initials': 'H', 'LastName': 'Zadeh', 'Affiliation': 'VISTA Institute for Therapeutic Innovations, Woodland Hills, CA, USA.'}, {'ForeName': 'Clark M', 'Initials': 'CM', 'LastName': 'Stanford', 'Affiliation': 'Department of Restorative Dentistry, University of Illinois at Chicago, Chicago, IL, USA.'}]",Clinical oral implants research,['10.1111/clr.13674']
3103,33025843,Efficacy of Combination Neoadjuvant Chemotherapy and Regional Inductive Moderate Hyperthermia in the Treatment of Patients With Locally Advanced Breast Cancer.,"PURPOSE


To evaluate the efficacy of neoadjuvant chemotherapy in combination with regional inductive moderate hyperthermia for patients with locally advanced breast cancer.
PATIENTS AND METHODS


200 patients with stage IIB-IIIA breast cancer received neoadjuvant chemotherapy (control group, n = 97) or chemotherapy combined with hyperthermia (experimental group, n = 103). Inductive hyperthermia was set at 27.12 ± 0.16 MHz and the 50 W output power.
RESULTS


Thermal and color Doppler ultrasound imaging demonstrated that hyperthermia increased the surface temperature on the breasts to < 4°С while the mean values for systolic blood flow were 3.5 times as high as those prior to treatment. Assessment of tumor size and response found a (31.24 ± 3.85)% reduction in the size of the primary tumor in patients receiving chemotherapy + hyperthermia, while chemotherapy alone showed a (22.95 ± 3.61)% decrease on average (p = 0.034). The rate of objective response increased by 15.9% in the experimental group (р = 0.034) compared with the control group. The patients in the experimental group also had axillary lymph node regression of 14.17% greater than in the control group (p = 0.011). Moreover, the combination treatment allowed to increase the proportion of women eligible for breast-conserving and reconstructive surgery by 13.63% in the experimental group. The viable tumor volume was lower in patients receiving neoadjuvant chemotherapy + hyperthermia (24.4 ± 0.2)% compared with those given chemotherapy alone (30.4 ± 0.25)%. The 10-year overall survival rates were higher (log-rank: p = 0.009) in breast cancer patients who underwent chemotherapy combined with hyperthermia than in patients receiving chemotherapy only.
CONCLUSION


The combination neoadjuvant chemotherapy and the technology of regional inductive moderate hyperthermia improved the efficacy of treatment for patients with locally advanced breast cancer staged IIB-IIIA.",2020,The rate of objective response increased by 15.9% in the experimental group (р = 0.034) compared with the control group.,"['patients with locally advanced breast cancer', 'Patients With Locally Advanced Breast Cancer', 'patients with locally advanced breast cancer staged IIB-IIIA', '200 patients with stage IIB-IIIA breast cancer received']","['chemotherapy combined with hyperthermia', 'neoadjuvant chemotherapy (control group, n = 97) or chemotherapy combined with hyperthermia', 'neoadjuvant chemotherapy', 'Combination Neoadjuvant Chemotherapy and Regional Inductive Moderate Hyperthermia']","['proportion of women eligible for breast-conserving and reconstructive surgery', 'surface temperature', 'systolic blood flow', '10-year overall survival rates', 'rate of objective response', 'viable tumor volume', 'axillary lymph node regression']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0441769', 'cui_str': 'Stage 2B'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}]","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0524865', 'cui_str': 'Reconstruction - action'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0443348', 'cui_str': 'Viable'}, {'cui': 'C0475276', 'cui_str': 'Tumor volume'}, {'cui': 'C0729594', 'cui_str': 'Axillary lymph node group'}, {'cui': 'C0684321', 'cui_str': 'Regression - mental defense mechanism'}]",200.0,0.0239746,The rate of objective response increased by 15.9% in the experimental group (р = 0.034) compared with the control group.,"[{'ForeName': 'Anton', 'Initials': 'A', 'LastName': 'Loboda', 'Affiliation': 'National Cancer Institute, Kyiv, Ukraine.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Smolanka', 'Affiliation': 'National Cancer Institute, Kyiv, Ukraine.'}, {'ForeName': 'Valerii E', 'Initials': 'VE', 'LastName': 'Orel', 'Affiliation': 'National Cancer Institute, Kyiv, Ukraine.'}, {'ForeName': 'Liubov', 'Initials': 'L', 'LastName': 'Syvak', 'Affiliation': 'National Cancer Institute, Kyiv, Ukraine.'}, {'ForeName': 'Tetiana', 'Initials': 'T', 'LastName': 'Golovko', 'Affiliation': 'National Cancer Institute, Kyiv, Ukraine.'}, {'ForeName': 'Iryna', 'Initials': 'I', 'LastName': 'Dosenko', 'Affiliation': 'National Cancer Institute, Kyiv, Ukraine.'}, {'ForeName': 'Andrii', 'Initials': 'A', 'LastName': 'Lyashenko', 'Affiliation': 'National Cancer Institute, Kyiv, Ukraine.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Smolanka', 'Affiliation': 'National Cancer Institute, Kyiv, Ukraine.'}, {'ForeName': 'Olha', 'Initials': 'O', 'LastName': 'Dasyukevich', 'Affiliation': 'National Cancer Institute, Kyiv, Ukraine.'}, {'ForeName': 'Tetiana', 'Initials': 'T', 'LastName': 'Tarasenko', 'Affiliation': 'National Cancer Institute, Kyiv, Ukraine.'}, {'ForeName': 'Valerii B', 'Initials': 'VB', 'LastName': 'Orel', 'Affiliation': 'National Cancer Institute, Kyiv, Ukraine.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Rykhalskyi', 'Affiliation': 'National Cancer Institute, Kyiv, Ukraine.'}, {'ForeName': 'Oleksandr', 'Initials': 'O', 'LastName': 'Ganich', 'Affiliation': 'National Cancer Institute, Kyiv, Ukraine.'}, {'ForeName': 'Oleksandr', 'Initials': 'O', 'LastName': 'Mokhonko', 'Affiliation': 'Biomedical Engineering Department, ""Igor Sikorsky Kyiv Polytechnic Institute,"" Kyiv, Ukraine.'}]",Technology in cancer research & treatment,['10.1177/1533033820963599']
3104,32991794,Safety and Immunogenicity of SARS-CoV-2 mRNA-1273 Vaccine in Older Adults.,"BACKGROUND


Testing of vaccine candidates to prevent infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in an older population is important, since increased incidences of illness and death from coronavirus disease 2019 (Covid-19) have been associated with an older age.
METHODS


We conducted a phase 1, dose-escalation, open-label trial of a messenger RNA vaccine, mRNA-1273, which encodes the stabilized prefusion SARS-CoV-2 spike protein (S-2P) in healthy adults. The trial was expanded to include 40 older adults, who were stratified according to age (56 to 70 years or ≥71 years). All the participants were assigned sequentially to receive two doses of either 25 μg or 100 μg of vaccine administered 28 days apart.
RESULTS


Solicited adverse events were predominantly mild or moderate in severity and most frequently included fatigue, chills, headache, myalgia, and pain at the injection site. Such adverse events were dose-dependent and were more common after the second immunization. Binding-antibody responses increased rapidly after the first immunization. By day 57, among the participants who received the 25-μg dose, the anti-S-2P geometric mean titer (GMT) was 323,945 among those between the ages of 56 and 70 years and 1,128,391 among those who were 71 years of age or older; among the participants who received the 100-μg dose, the GMT in the two age subgroups was 1,183,066 and 3,638,522, respectively. After the second immunization, serum neutralizing activity was detected in all the participants by multiple methods. Binding- and neutralizing-antibody responses appeared to be similar to those previously reported among vaccine recipients between the ages of 18 and 55 years and were above the median of a panel of controls who had donated convalescent serum. The vaccine elicited a strong CD4 cytokine response involving type 1 helper T cells.
CONCLUSIONS


In this small study involving older adults, adverse events associated with the mRNA-1273 vaccine were mainly mild or moderate. The 100-μg dose induced higher binding- and neutralizing-antibody titers than the 25-μg dose, which supports the use of the 100-μg dose in a phase 3 vaccine trial. (Funded by the National Institute of Allergy and Infectious Diseases and others; mRNA-1273 Study ClinicalTrials.gov number, NCT04283461.).",2020,"The 100-μg dose induced higher binding- and neutralizing-antibody titers than the 25-μg dose, which supports the use of the 100-μg dose in a phase 3 vaccine trial.","['was 323,945 among those between the ages of 56 and 70 years and 1,128,391 among those who were 71 years of age or older; among the participants who received the 100-μg dose, the GMT in the two age subgroups was 1,183,066 and 3,638,522, respectively', '40 older adults, who were stratified according to age (56 to 70 years or ≥71 years', 'healthy adults', 'Older Adults']","['RNA vaccine, mRNA-1273, which encodes the stabilized prefusion SARS-CoV-2 spike protein (S-2P', 'vaccine', 'SARS-CoV-2 mRNA-1273 Vaccine']","['Binding- and neutralizing-antibody responses', 'serum neutralizing activity', 'binding- and neutralizing-antibody titers', 'Binding-antibody responses', 'fatigue, chills, headache, myalgia, and pain', 'CD4 cytokine response', 'anti-S-2P geometric mean titer (GMT']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}]","[{'cui': 'C0332297', 'cui_str': 'Bounded by'}, {'cui': 'C0282682', 'cui_str': 'Blocking antibody'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0003261', 'cui_str': 'Antibody Production'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0085593', 'cui_str': 'Chill'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0221141', 'cui_str': 'Blood group antibody S'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",40.0,0.148609,"The 100-μg dose induced higher binding- and neutralizing-antibody titers than the 25-μg dose, which supports the use of the 100-μg dose in a phase 3 vaccine trial.","[{'ForeName': 'Evan J', 'Initials': 'EJ', 'LastName': 'Anderson', 'Affiliation': ""From the Center for Childhood Infections and Vaccines of Children's Healthcare of Atlanta and the Department of Pediatrics, Emory University School of Medicine (E.J.A., V.V.E., K.F., M.S.S., C.A.R.), and Emory Vaccine Center, Yerkes National Primate Research Center, Emory University (M.S.S.), Atlanta, and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (E.J.A., N.G.R., V.K.P.) - both in Georgia; the Vaccine Research Center (A.T.W., A.B.M., B.F., B.C.L., N.A.D.-R., S.O., S.D.S., K.S.C., P.A.S., M.P., J.E.L., B.S.G.) and the Division of Microbiology and Infectious Diseases (P.C.R., M. Makhene, W.B., C.J.L., J.H.B.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the University of Maryland School of Medicine, Baltimore (K.M.N.), and the Emmes Company, Rockville (M. Makowski, J.A., K.C.) - all in Maryland; Kaiser Permanente Washington Health Research Institute, Seattle (L.A.J.); the Department of Pediatrics (J.D.C., M.R.D., L.J.S., A.J.P.), the Vanderbilt Institute for Infection, Immunology, and Inflammation (J.D.C., M.R.D., A.J.P.), and the Departments of Pathology, Microbiology, and Immunology (M.R.D.), Vanderbilt University Medical Center, Nashville; Moderna, Cambridge, MA (H.B., B.L.); and the Departments of Epidemiology and Microbiology and Immunology, University of North Carolina at Chapel Hill, Chapel Hill (D.R.M., R.B.).""}, {'ForeName': 'Nadine G', 'Initials': 'NG', 'LastName': 'Rouphael', 'Affiliation': ""From the Center for Childhood Infections and Vaccines of Children's Healthcare of Atlanta and the Department of Pediatrics, Emory University School of Medicine (E.J.A., V.V.E., K.F., M.S.S., C.A.R.), and Emory Vaccine Center, Yerkes National Primate Research Center, Emory University (M.S.S.), Atlanta, and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (E.J.A., N.G.R., V.K.P.) - both in Georgia; the Vaccine Research Center (A.T.W., A.B.M., B.F., B.C.L., N.A.D.-R., S.O., S.D.S., K.S.C., P.A.S., M.P., J.E.L., B.S.G.) and the Division of Microbiology and Infectious Diseases (P.C.R., M. Makhene, W.B., C.J.L., J.H.B.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the University of Maryland School of Medicine, Baltimore (K.M.N.), and the Emmes Company, Rockville (M. Makowski, J.A., K.C.) - all in Maryland; Kaiser Permanente Washington Health Research Institute, Seattle (L.A.J.); the Department of Pediatrics (J.D.C., M.R.D., L.J.S., A.J.P.), the Vanderbilt Institute for Infection, Immunology, and Inflammation (J.D.C., M.R.D., A.J.P.), and the Departments of Pathology, Microbiology, and Immunology (M.R.D.), Vanderbilt University Medical Center, Nashville; Moderna, Cambridge, MA (H.B., B.L.); and the Departments of Epidemiology and Microbiology and Immunology, University of North Carolina at Chapel Hill, Chapel Hill (D.R.M., R.B.).""}, {'ForeName': 'Alicia T', 'Initials': 'AT', 'LastName': 'Widge', 'Affiliation': ""From the Center for Childhood Infections and Vaccines of Children's Healthcare of Atlanta and the Department of Pediatrics, Emory University School of Medicine (E.J.A., V.V.E., K.F., M.S.S., C.A.R.), and Emory Vaccine Center, Yerkes National Primate Research Center, Emory University (M.S.S.), Atlanta, and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (E.J.A., N.G.R., V.K.P.) - both in Georgia; the Vaccine Research Center (A.T.W., A.B.M., B.F., B.C.L., N.A.D.-R., S.O., S.D.S., K.S.C., P.A.S., M.P., J.E.L., B.S.G.) and the Division of Microbiology and Infectious Diseases (P.C.R., M. Makhene, W.B., C.J.L., J.H.B.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the University of Maryland School of Medicine, Baltimore (K.M.N.), and the Emmes Company, Rockville (M. Makowski, J.A., K.C.) - all in Maryland; Kaiser Permanente Washington Health Research Institute, Seattle (L.A.J.); the Department of Pediatrics (J.D.C., M.R.D., L.J.S., A.J.P.), the Vanderbilt Institute for Infection, Immunology, and Inflammation (J.D.C., M.R.D., A.J.P.), and the Departments of Pathology, Microbiology, and Immunology (M.R.D.), Vanderbilt University Medical Center, Nashville; Moderna, Cambridge, MA (H.B., B.L.); and the Departments of Epidemiology and Microbiology and Immunology, University of North Carolina at Chapel Hill, Chapel Hill (D.R.M., R.B.).""}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Jackson', 'Affiliation': ""From the Center for Childhood Infections and Vaccines of Children's Healthcare of Atlanta and the Department of Pediatrics, Emory University School of Medicine (E.J.A., V.V.E., K.F., M.S.S., C.A.R.), and Emory Vaccine Center, Yerkes National Primate Research Center, Emory University (M.S.S.), Atlanta, and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (E.J.A., N.G.R., V.K.P.) - both in Georgia; the Vaccine Research Center (A.T.W., A.B.M., B.F., B.C.L., N.A.D.-R., S.O., S.D.S., K.S.C., P.A.S., M.P., J.E.L., B.S.G.) and the Division of Microbiology and Infectious Diseases (P.C.R., M. Makhene, W.B., C.J.L., J.H.B.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the University of Maryland School of Medicine, Baltimore (K.M.N.), and the Emmes Company, Rockville (M. Makowski, J.A., K.C.) - all in Maryland; Kaiser Permanente Washington Health Research Institute, Seattle (L.A.J.); the Department of Pediatrics (J.D.C., M.R.D., L.J.S., A.J.P.), the Vanderbilt Institute for Infection, Immunology, and Inflammation (J.D.C., M.R.D., A.J.P.), and the Departments of Pathology, Microbiology, and Immunology (M.R.D.), Vanderbilt University Medical Center, Nashville; Moderna, Cambridge, MA (H.B., B.L.); and the Departments of Epidemiology and Microbiology and Immunology, University of North Carolina at Chapel Hill, Chapel Hill (D.R.M., R.B.).""}, {'ForeName': 'Paul C', 'Initials': 'PC', 'LastName': 'Roberts', 'Affiliation': ""From the Center for Childhood Infections and Vaccines of Children's Healthcare of Atlanta and the Department of Pediatrics, Emory University School of Medicine (E.J.A., V.V.E., K.F., M.S.S., C.A.R.), and Emory Vaccine Center, Yerkes National Primate Research Center, Emory University (M.S.S.), Atlanta, and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (E.J.A., N.G.R., V.K.P.) - both in Georgia; the Vaccine Research Center (A.T.W., A.B.M., B.F., B.C.L., N.A.D.-R., S.O., S.D.S., K.S.C., P.A.S., M.P., J.E.L., B.S.G.) and the Division of Microbiology and Infectious Diseases (P.C.R., M. Makhene, W.B., C.J.L., J.H.B.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the University of Maryland School of Medicine, Baltimore (K.M.N.), and the Emmes Company, Rockville (M. Makowski, J.A., K.C.) - all in Maryland; Kaiser Permanente Washington Health Research Institute, Seattle (L.A.J.); the Department of Pediatrics (J.D.C., M.R.D., L.J.S., A.J.P.), the Vanderbilt Institute for Infection, Immunology, and Inflammation (J.D.C., M.R.D., A.J.P.), and the Departments of Pathology, Microbiology, and Immunology (M.R.D.), Vanderbilt University Medical Center, Nashville; Moderna, Cambridge, MA (H.B., B.L.); and the Departments of Epidemiology and Microbiology and Immunology, University of North Carolina at Chapel Hill, Chapel Hill (D.R.M., R.B.).""}, {'ForeName': 'Mamodikoe', 'Initials': 'M', 'LastName': 'Makhene', 'Affiliation': ""From the Center for Childhood Infections and Vaccines of Children's Healthcare of Atlanta and the Department of Pediatrics, Emory University School of Medicine (E.J.A., V.V.E., K.F., M.S.S., C.A.R.), and Emory Vaccine Center, Yerkes National Primate Research Center, Emory University (M.S.S.), Atlanta, and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (E.J.A., N.G.R., V.K.P.) - both in Georgia; the Vaccine Research Center (A.T.W., A.B.M., B.F., B.C.L., N.A.D.-R., S.O., S.D.S., K.S.C., P.A.S., M.P., J.E.L., B.S.G.) and the Division of Microbiology and Infectious Diseases (P.C.R., M. Makhene, W.B., C.J.L., J.H.B.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the University of Maryland School of Medicine, Baltimore (K.M.N.), and the Emmes Company, Rockville (M. Makowski, J.A., K.C.) - all in Maryland; Kaiser Permanente Washington Health Research Institute, Seattle (L.A.J.); the Department of Pediatrics (J.D.C., M.R.D., L.J.S., A.J.P.), the Vanderbilt Institute for Infection, Immunology, and Inflammation (J.D.C., M.R.D., A.J.P.), and the Departments of Pathology, Microbiology, and Immunology (M.R.D.), Vanderbilt University Medical Center, Nashville; Moderna, Cambridge, MA (H.B., B.L.); and the Departments of Epidemiology and Microbiology and Immunology, University of North Carolina at Chapel Hill, Chapel Hill (D.R.M., R.B.).""}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Chappell', 'Affiliation': ""From the Center for Childhood Infections and Vaccines of Children's Healthcare of Atlanta and the Department of Pediatrics, Emory University School of Medicine (E.J.A., V.V.E., K.F., M.S.S., C.A.R.), and Emory Vaccine Center, Yerkes National Primate Research Center, Emory University (M.S.S.), Atlanta, and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (E.J.A., N.G.R., V.K.P.) - both in Georgia; the Vaccine Research Center (A.T.W., A.B.M., B.F., B.C.L., N.A.D.-R., S.O., S.D.S., K.S.C., P.A.S., M.P., J.E.L., B.S.G.) and the Division of Microbiology and Infectious Diseases (P.C.R., M. Makhene, W.B., C.J.L., J.H.B.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the University of Maryland School of Medicine, Baltimore (K.M.N.), and the Emmes Company, Rockville (M. Makowski, J.A., K.C.) - all in Maryland; Kaiser Permanente Washington Health Research Institute, Seattle (L.A.J.); the Department of Pediatrics (J.D.C., M.R.D., L.J.S., A.J.P.), the Vanderbilt Institute for Infection, Immunology, and Inflammation (J.D.C., M.R.D., A.J.P.), and the Departments of Pathology, Microbiology, and Immunology (M.R.D.), Vanderbilt University Medical Center, Nashville; Moderna, Cambridge, MA (H.B., B.L.); and the Departments of Epidemiology and Microbiology and Immunology, University of North Carolina at Chapel Hill, Chapel Hill (D.R.M., R.B.).""}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Denison', 'Affiliation': ""From the Center for Childhood Infections and Vaccines of Children's Healthcare of Atlanta and the Department of Pediatrics, Emory University School of Medicine (E.J.A., V.V.E., K.F., M.S.S., C.A.R.), and Emory Vaccine Center, Yerkes National Primate Research Center, Emory University (M.S.S.), Atlanta, and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (E.J.A., N.G.R., V.K.P.) - both in Georgia; the Vaccine Research Center (A.T.W., A.B.M., B.F., B.C.L., N.A.D.-R., S.O., S.D.S., K.S.C., P.A.S., M.P., J.E.L., B.S.G.) and the Division of Microbiology and Infectious Diseases (P.C.R., M. Makhene, W.B., C.J.L., J.H.B.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the University of Maryland School of Medicine, Baltimore (K.M.N.), and the Emmes Company, Rockville (M. Makowski, J.A., K.C.) - all in Maryland; Kaiser Permanente Washington Health Research Institute, Seattle (L.A.J.); the Department of Pediatrics (J.D.C., M.R.D., L.J.S., A.J.P.), the Vanderbilt Institute for Infection, Immunology, and Inflammation (J.D.C., M.R.D., A.J.P.), and the Departments of Pathology, Microbiology, and Immunology (M.R.D.), Vanderbilt University Medical Center, Nashville; Moderna, Cambridge, MA (H.B., B.L.); and the Departments of Epidemiology and Microbiology and Immunology, University of North Carolina at Chapel Hill, Chapel Hill (D.R.M., R.B.).""}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Stevens', 'Affiliation': ""From the Center for Childhood Infections and Vaccines of Children's Healthcare of Atlanta and the Department of Pediatrics, Emory University School of Medicine (E.J.A., V.V.E., K.F., M.S.S., C.A.R.), and Emory Vaccine Center, Yerkes National Primate Research Center, Emory University (M.S.S.), Atlanta, and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (E.J.A., N.G.R., V.K.P.) - both in Georgia; the Vaccine Research Center (A.T.W., A.B.M., B.F., B.C.L., N.A.D.-R., S.O., S.D.S., K.S.C., P.A.S., M.P., J.E.L., B.S.G.) and the Division of Microbiology and Infectious Diseases (P.C.R., M. Makhene, W.B., C.J.L., J.H.B.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the University of Maryland School of Medicine, Baltimore (K.M.N.), and the Emmes Company, Rockville (M. Makowski, J.A., K.C.) - all in Maryland; Kaiser Permanente Washington Health Research Institute, Seattle (L.A.J.); the Department of Pediatrics (J.D.C., M.R.D., L.J.S., A.J.P.), the Vanderbilt Institute for Infection, Immunology, and Inflammation (J.D.C., M.R.D., A.J.P.), and the Departments of Pathology, Microbiology, and Immunology (M.R.D.), Vanderbilt University Medical Center, Nashville; Moderna, Cambridge, MA (H.B., B.L.); and the Departments of Epidemiology and Microbiology and Immunology, University of North Carolina at Chapel Hill, Chapel Hill (D.R.M., R.B.).""}, {'ForeName': 'Andrea J', 'Initials': 'AJ', 'LastName': 'Pruijssers', 'Affiliation': ""From the Center for Childhood Infections and Vaccines of Children's Healthcare of Atlanta and the Department of Pediatrics, Emory University School of Medicine (E.J.A., V.V.E., K.F., M.S.S., C.A.R.), and Emory Vaccine Center, Yerkes National Primate Research Center, Emory University (M.S.S.), Atlanta, and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (E.J.A., N.G.R., V.K.P.) - both in Georgia; the Vaccine Research Center (A.T.W., A.B.M., B.F., B.C.L., N.A.D.-R., S.O., S.D.S., K.S.C., P.A.S., M.P., J.E.L., B.S.G.) and the Division of Microbiology and Infectious Diseases (P.C.R., M. Makhene, W.B., C.J.L., J.H.B.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the University of Maryland School of Medicine, Baltimore (K.M.N.), and the Emmes Company, Rockville (M. Makowski, J.A., K.C.) - all in Maryland; Kaiser Permanente Washington Health Research Institute, Seattle (L.A.J.); the Department of Pediatrics (J.D.C., M.R.D., L.J.S., A.J.P.), the Vanderbilt Institute for Infection, Immunology, and Inflammation (J.D.C., M.R.D., A.J.P.), and the Departments of Pathology, Microbiology, and Immunology (M.R.D.), Vanderbilt University Medical Center, Nashville; Moderna, Cambridge, MA (H.B., B.L.); and the Departments of Epidemiology and Microbiology and Immunology, University of North Carolina at Chapel Hill, Chapel Hill (D.R.M., R.B.).""}, {'ForeName': 'Adrian B', 'Initials': 'AB', 'LastName': 'McDermott', 'Affiliation': ""From the Center for Childhood Infections and Vaccines of Children's Healthcare of Atlanta and the Department of Pediatrics, Emory University School of Medicine (E.J.A., V.V.E., K.F., M.S.S., C.A.R.), and Emory Vaccine Center, Yerkes National Primate Research Center, Emory University (M.S.S.), Atlanta, and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (E.J.A., N.G.R., V.K.P.) - both in Georgia; the Vaccine Research Center (A.T.W., A.B.M., B.F., B.C.L., N.A.D.-R., S.O., S.D.S., K.S.C., P.A.S., M.P., J.E.L., B.S.G.) and the Division of Microbiology and Infectious Diseases (P.C.R., M. Makhene, W.B., C.J.L., J.H.B.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the University of Maryland School of Medicine, Baltimore (K.M.N.), and the Emmes Company, Rockville (M. Makowski, J.A., K.C.) - all in Maryland; Kaiser Permanente Washington Health Research Institute, Seattle (L.A.J.); the Department of Pediatrics (J.D.C., M.R.D., L.J.S., A.J.P.), the Vanderbilt Institute for Infection, Immunology, and Inflammation (J.D.C., M.R.D., A.J.P.), and the Departments of Pathology, Microbiology, and Immunology (M.R.D.), Vanderbilt University Medical Center, Nashville; Moderna, Cambridge, MA (H.B., B.L.); and the Departments of Epidemiology and Microbiology and Immunology, University of North Carolina at Chapel Hill, Chapel Hill (D.R.M., R.B.).""}, {'ForeName': 'Britta', 'Initials': 'B', 'LastName': 'Flach', 'Affiliation': ""From the Center for Childhood Infections and Vaccines of Children's Healthcare of Atlanta and the Department of Pediatrics, Emory University School of Medicine (E.J.A., V.V.E., K.F., M.S.S., C.A.R.), and Emory Vaccine Center, Yerkes National Primate Research Center, Emory University (M.S.S.), Atlanta, and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (E.J.A., N.G.R., V.K.P.) - both in Georgia; the Vaccine Research Center (A.T.W., A.B.M., B.F., B.C.L., N.A.D.-R., S.O., S.D.S., K.S.C., P.A.S., M.P., J.E.L., B.S.G.) and the Division of Microbiology and Infectious Diseases (P.C.R., M. Makhene, W.B., C.J.L., J.H.B.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the University of Maryland School of Medicine, Baltimore (K.M.N.), and the Emmes Company, Rockville (M. Makowski, J.A., K.C.) - all in Maryland; Kaiser Permanente Washington Health Research Institute, Seattle (L.A.J.); the Department of Pediatrics (J.D.C., M.R.D., L.J.S., A.J.P.), the Vanderbilt Institute for Infection, Immunology, and Inflammation (J.D.C., M.R.D., A.J.P.), and the Departments of Pathology, Microbiology, and Immunology (M.R.D.), Vanderbilt University Medical Center, Nashville; Moderna, Cambridge, MA (H.B., B.L.); and the Departments of Epidemiology and Microbiology and Immunology, University of North Carolina at Chapel Hill, Chapel Hill (D.R.M., R.B.).""}, {'ForeName': 'Bob C', 'Initials': 'BC', 'LastName': 'Lin', 'Affiliation': ""From the Center for Childhood Infections and Vaccines of Children's Healthcare of Atlanta and the Department of Pediatrics, Emory University School of Medicine (E.J.A., V.V.E., K.F., M.S.S., C.A.R.), and Emory Vaccine Center, Yerkes National Primate Research Center, Emory University (M.S.S.), Atlanta, and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (E.J.A., N.G.R., V.K.P.) - both in Georgia; the Vaccine Research Center (A.T.W., A.B.M., B.F., B.C.L., N.A.D.-R., S.O., S.D.S., K.S.C., P.A.S., M.P., J.E.L., B.S.G.) and the Division of Microbiology and Infectious Diseases (P.C.R., M. Makhene, W.B., C.J.L., J.H.B.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the University of Maryland School of Medicine, Baltimore (K.M.N.), and the Emmes Company, Rockville (M. Makowski, J.A., K.C.) - all in Maryland; Kaiser Permanente Washington Health Research Institute, Seattle (L.A.J.); the Department of Pediatrics (J.D.C., M.R.D., L.J.S., A.J.P.), the Vanderbilt Institute for Infection, Immunology, and Inflammation (J.D.C., M.R.D., A.J.P.), and the Departments of Pathology, Microbiology, and Immunology (M.R.D.), Vanderbilt University Medical Center, Nashville; Moderna, Cambridge, MA (H.B., B.L.); and the Departments of Epidemiology and Microbiology and Immunology, University of North Carolina at Chapel Hill, Chapel Hill (D.R.M., R.B.).""}, {'ForeName': 'Nicole A', 'Initials': 'NA', 'LastName': 'Doria-Rose', 'Affiliation': ""From the Center for Childhood Infections and Vaccines of Children's Healthcare of Atlanta and the Department of Pediatrics, Emory University School of Medicine (E.J.A., V.V.E., K.F., M.S.S., C.A.R.), and Emory Vaccine Center, Yerkes National Primate Research Center, Emory University (M.S.S.), Atlanta, and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (E.J.A., N.G.R., V.K.P.) - both in Georgia; the Vaccine Research Center (A.T.W., A.B.M., B.F., B.C.L., N.A.D.-R., S.O., S.D.S., K.S.C., P.A.S., M.P., J.E.L., B.S.G.) and the Division of Microbiology and Infectious Diseases (P.C.R., M. Makhene, W.B., C.J.L., J.H.B.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the University of Maryland School of Medicine, Baltimore (K.M.N.), and the Emmes Company, Rockville (M. Makowski, J.A., K.C.) - all in Maryland; Kaiser Permanente Washington Health Research Institute, Seattle (L.A.J.); the Department of Pediatrics (J.D.C., M.R.D., L.J.S., A.J.P.), the Vanderbilt Institute for Infection, Immunology, and Inflammation (J.D.C., M.R.D., A.J.P.), and the Departments of Pathology, Microbiology, and Immunology (M.R.D.), Vanderbilt University Medical Center, Nashville; Moderna, Cambridge, MA (H.B., B.L.); and the Departments of Epidemiology and Microbiology and Immunology, University of North Carolina at Chapel Hill, Chapel Hill (D.R.M., R.B.).""}, {'ForeName': 'Sijy', 'Initials': 'S', 'LastName': ""O'Dell"", 'Affiliation': ""From the Center for Childhood Infections and Vaccines of Children's Healthcare of Atlanta and the Department of Pediatrics, Emory University School of Medicine (E.J.A., V.V.E., K.F., M.S.S., C.A.R.), and Emory Vaccine Center, Yerkes National Primate Research Center, Emory University (M.S.S.), Atlanta, and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (E.J.A., N.G.R., V.K.P.) - both in Georgia; the Vaccine Research Center (A.T.W., A.B.M., B.F., B.C.L., N.A.D.-R., S.O., S.D.S., K.S.C., P.A.S., M.P., J.E.L., B.S.G.) and the Division of Microbiology and Infectious Diseases (P.C.R., M. Makhene, W.B., C.J.L., J.H.B.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the University of Maryland School of Medicine, Baltimore (K.M.N.), and the Emmes Company, Rockville (M. Makowski, J.A., K.C.) - all in Maryland; Kaiser Permanente Washington Health Research Institute, Seattle (L.A.J.); the Department of Pediatrics (J.D.C., M.R.D., L.J.S., A.J.P.), the Vanderbilt Institute for Infection, Immunology, and Inflammation (J.D.C., M.R.D., A.J.P.), and the Departments of Pathology, Microbiology, and Immunology (M.R.D.), Vanderbilt University Medical Center, Nashville; Moderna, Cambridge, MA (H.B., B.L.); and the Departments of Epidemiology and Microbiology and Immunology, University of North Carolina at Chapel Hill, Chapel Hill (D.R.M., R.B.).""}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Schmidt', 'Affiliation': ""From the Center for Childhood Infections and Vaccines of Children's Healthcare of Atlanta and the Department of Pediatrics, Emory University School of Medicine (E.J.A., V.V.E., K.F., M.S.S., C.A.R.), and Emory Vaccine Center, Yerkes National Primate Research Center, Emory University (M.S.S.), Atlanta, and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (E.J.A., N.G.R., V.K.P.) - both in Georgia; the Vaccine Research Center (A.T.W., A.B.M., B.F., B.C.L., N.A.D.-R., S.O., S.D.S., K.S.C., P.A.S., M.P., J.E.L., B.S.G.) and the Division of Microbiology and Infectious Diseases (P.C.R., M. Makhene, W.B., C.J.L., J.H.B.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the University of Maryland School of Medicine, Baltimore (K.M.N.), and the Emmes Company, Rockville (M. Makowski, J.A., K.C.) - all in Maryland; Kaiser Permanente Washington Health Research Institute, Seattle (L.A.J.); the Department of Pediatrics (J.D.C., M.R.D., L.J.S., A.J.P.), the Vanderbilt Institute for Infection, Immunology, and Inflammation (J.D.C., M.R.D., A.J.P.), and the Departments of Pathology, Microbiology, and Immunology (M.R.D.), Vanderbilt University Medical Center, Nashville; Moderna, Cambridge, MA (H.B., B.L.); and the Departments of Epidemiology and Microbiology and Immunology, University of North Carolina at Chapel Hill, Chapel Hill (D.R.M., R.B.).""}, {'ForeName': 'Kizzmekia S', 'Initials': 'KS', 'LastName': 'Corbett', 'Affiliation': ""From the Center for Childhood Infections and Vaccines of Children's Healthcare of Atlanta and the Department of Pediatrics, Emory University School of Medicine (E.J.A., V.V.E., K.F., M.S.S., C.A.R.), and Emory Vaccine Center, Yerkes National Primate Research Center, Emory University (M.S.S.), Atlanta, and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (E.J.A., N.G.R., V.K.P.) - both in Georgia; the Vaccine Research Center (A.T.W., A.B.M., B.F., B.C.L., N.A.D.-R., S.O., S.D.S., K.S.C., P.A.S., M.P., J.E.L., B.S.G.) and the Division of Microbiology and Infectious Diseases (P.C.R., M. Makhene, W.B., C.J.L., J.H.B.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the University of Maryland School of Medicine, Baltimore (K.M.N.), and the Emmes Company, Rockville (M. Makowski, J.A., K.C.) - all in Maryland; Kaiser Permanente Washington Health Research Institute, Seattle (L.A.J.); the Department of Pediatrics (J.D.C., M.R.D., L.J.S., A.J.P.), the Vanderbilt Institute for Infection, Immunology, and Inflammation (J.D.C., M.R.D., A.J.P.), and the Departments of Pathology, Microbiology, and Immunology (M.R.D.), Vanderbilt University Medical Center, Nashville; Moderna, Cambridge, MA (H.B., B.L.); and the Departments of Epidemiology and Microbiology and Immunology, University of North Carolina at Chapel Hill, Chapel Hill (D.R.M., R.B.).""}, {'ForeName': 'Phillip A', 'Initials': 'PA', 'LastName': 'Swanson', 'Affiliation': ""From the Center for Childhood Infections and Vaccines of Children's Healthcare of Atlanta and the Department of Pediatrics, Emory University School of Medicine (E.J.A., V.V.E., K.F., M.S.S., C.A.R.), and Emory Vaccine Center, Yerkes National Primate Research Center, Emory University (M.S.S.), Atlanta, and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (E.J.A., N.G.R., V.K.P.) - both in Georgia; the Vaccine Research Center (A.T.W., A.B.M., B.F., B.C.L., N.A.D.-R., S.O., S.D.S., K.S.C., P.A.S., M.P., J.E.L., B.S.G.) and the Division of Microbiology and Infectious Diseases (P.C.R., M. Makhene, W.B., C.J.L., J.H.B.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the University of Maryland School of Medicine, Baltimore (K.M.N.), and the Emmes Company, Rockville (M. Makowski, J.A., K.C.) - all in Maryland; Kaiser Permanente Washington Health Research Institute, Seattle (L.A.J.); the Department of Pediatrics (J.D.C., M.R.D., L.J.S., A.J.P.), the Vanderbilt Institute for Infection, Immunology, and Inflammation (J.D.C., M.R.D., A.J.P.), and the Departments of Pathology, Microbiology, and Immunology (M.R.D.), Vanderbilt University Medical Center, Nashville; Moderna, Cambridge, MA (H.B., B.L.); and the Departments of Epidemiology and Microbiology and Immunology, University of North Carolina at Chapel Hill, Chapel Hill (D.R.M., R.B.).""}, {'ForeName': 'Marcelino', 'Initials': 'M', 'LastName': 'Padilla', 'Affiliation': ""From the Center for Childhood Infections and Vaccines of Children's Healthcare of Atlanta and the Department of Pediatrics, Emory University School of Medicine (E.J.A., V.V.E., K.F., M.S.S., C.A.R.), and Emory Vaccine Center, Yerkes National Primate Research Center, Emory University (M.S.S.), Atlanta, and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (E.J.A., N.G.R., V.K.P.) - both in Georgia; the Vaccine Research Center (A.T.W., A.B.M., B.F., B.C.L., N.A.D.-R., S.O., S.D.S., K.S.C., P.A.S., M.P., J.E.L., B.S.G.) and the Division of Microbiology and Infectious Diseases (P.C.R., M. Makhene, W.B., C.J.L., J.H.B.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the University of Maryland School of Medicine, Baltimore (K.M.N.), and the Emmes Company, Rockville (M. Makowski, J.A., K.C.) - all in Maryland; Kaiser Permanente Washington Health Research Institute, Seattle (L.A.J.); the Department of Pediatrics (J.D.C., M.R.D., L.J.S., A.J.P.), the Vanderbilt Institute for Infection, Immunology, and Inflammation (J.D.C., M.R.D., A.J.P.), and the Departments of Pathology, Microbiology, and Immunology (M.R.D.), Vanderbilt University Medical Center, Nashville; Moderna, Cambridge, MA (H.B., B.L.); and the Departments of Epidemiology and Microbiology and Immunology, University of North Carolina at Chapel Hill, Chapel Hill (D.R.M., R.B.).""}, {'ForeName': 'Kathy M', 'Initials': 'KM', 'LastName': 'Neuzil', 'Affiliation': ""From the Center for Childhood Infections and Vaccines of Children's Healthcare of Atlanta and the Department of Pediatrics, Emory University School of Medicine (E.J.A., V.V.E., K.F., M.S.S., C.A.R.), and Emory Vaccine Center, Yerkes National Primate Research Center, Emory University (M.S.S.), Atlanta, and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (E.J.A., N.G.R., V.K.P.) - both in Georgia; the Vaccine Research Center (A.T.W., A.B.M., B.F., B.C.L., N.A.D.-R., S.O., S.D.S., K.S.C., P.A.S., M.P., J.E.L., B.S.G.) and the Division of Microbiology and Infectious Diseases (P.C.R., M. Makhene, W.B., C.J.L., J.H.B.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the University of Maryland School of Medicine, Baltimore (K.M.N.), and the Emmes Company, Rockville (M. Makowski, J.A., K.C.) - all in Maryland; Kaiser Permanente Washington Health Research Institute, Seattle (L.A.J.); the Department of Pediatrics (J.D.C., M.R.D., L.J.S., A.J.P.), the Vanderbilt Institute for Infection, Immunology, and Inflammation (J.D.C., M.R.D., A.J.P.), and the Departments of Pathology, Microbiology, and Immunology (M.R.D.), Vanderbilt University Medical Center, Nashville; Moderna, Cambridge, MA (H.B., B.L.); and the Departments of Epidemiology and Microbiology and Immunology, University of North Carolina at Chapel Hill, Chapel Hill (D.R.M., R.B.).""}, {'ForeName': 'Hamilton', 'Initials': 'H', 'LastName': 'Bennett', 'Affiliation': ""From the Center for Childhood Infections and Vaccines of Children's Healthcare of Atlanta and the Department of Pediatrics, Emory University School of Medicine (E.J.A., V.V.E., K.F., M.S.S., C.A.R.), and Emory Vaccine Center, Yerkes National Primate Research Center, Emory University (M.S.S.), Atlanta, and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (E.J.A., N.G.R., V.K.P.) - both in Georgia; the Vaccine Research Center (A.T.W., A.B.M., B.F., B.C.L., N.A.D.-R., S.O., S.D.S., K.S.C., P.A.S., M.P., J.E.L., B.S.G.) and the Division of Microbiology and Infectious Diseases (P.C.R., M. Makhene, W.B., C.J.L., J.H.B.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the University of Maryland School of Medicine, Baltimore (K.M.N.), and the Emmes Company, Rockville (M. Makowski, J.A., K.C.) - all in Maryland; Kaiser Permanente Washington Health Research Institute, Seattle (L.A.J.); the Department of Pediatrics (J.D.C., M.R.D., L.J.S., A.J.P.), the Vanderbilt Institute for Infection, Immunology, and Inflammation (J.D.C., M.R.D., A.J.P.), and the Departments of Pathology, Microbiology, and Immunology (M.R.D.), Vanderbilt University Medical Center, Nashville; Moderna, Cambridge, MA (H.B., B.L.); and the Departments of Epidemiology and Microbiology and Immunology, University of North Carolina at Chapel Hill, Chapel Hill (D.R.M., R.B.).""}, {'ForeName': 'Brett', 'Initials': 'B', 'LastName': 'Leav', 'Affiliation': ""From the Center for Childhood Infections and Vaccines of Children's Healthcare of Atlanta and the Department of Pediatrics, Emory University School of Medicine (E.J.A., V.V.E., K.F., M.S.S., C.A.R.), and Emory Vaccine Center, Yerkes National Primate Research Center, Emory University (M.S.S.), Atlanta, and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (E.J.A., N.G.R., V.K.P.) - both in Georgia; the Vaccine Research Center (A.T.W., A.B.M., B.F., B.C.L., N.A.D.-R., S.O., S.D.S., K.S.C., P.A.S., M.P., J.E.L., B.S.G.) and the Division of Microbiology and Infectious Diseases (P.C.R., M. Makhene, W.B., C.J.L., J.H.B.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the University of Maryland School of Medicine, Baltimore (K.M.N.), and the Emmes Company, Rockville (M. Makowski, J.A., K.C.) - all in Maryland; Kaiser Permanente Washington Health Research Institute, Seattle (L.A.J.); the Department of Pediatrics (J.D.C., M.R.D., L.J.S., A.J.P.), the Vanderbilt Institute for Infection, Immunology, and Inflammation (J.D.C., M.R.D., A.J.P.), and the Departments of Pathology, Microbiology, and Immunology (M.R.D.), Vanderbilt University Medical Center, Nashville; Moderna, Cambridge, MA (H.B., B.L.); and the Departments of Epidemiology and Microbiology and Immunology, University of North Carolina at Chapel Hill, Chapel Hill (D.R.M., R.B.).""}, {'ForeName': 'Mat', 'Initials': 'M', 'LastName': 'Makowski', 'Affiliation': ""From the Center for Childhood Infections and Vaccines of Children's Healthcare of Atlanta and the Department of Pediatrics, Emory University School of Medicine (E.J.A., V.V.E., K.F., M.S.S., C.A.R.), and Emory Vaccine Center, Yerkes National Primate Research Center, Emory University (M.S.S.), Atlanta, and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (E.J.A., N.G.R., V.K.P.) - both in Georgia; the Vaccine Research Center (A.T.W., A.B.M., B.F., B.C.L., N.A.D.-R., S.O., S.D.S., K.S.C., P.A.S., M.P., J.E.L., B.S.G.) and the Division of Microbiology and Infectious Diseases (P.C.R., M. Makhene, W.B., C.J.L., J.H.B.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the University of Maryland School of Medicine, Baltimore (K.M.N.), and the Emmes Company, Rockville (M. Makowski, J.A., K.C.) - all in Maryland; Kaiser Permanente Washington Health Research Institute, Seattle (L.A.J.); the Department of Pediatrics (J.D.C., M.R.D., L.J.S., A.J.P.), the Vanderbilt Institute for Infection, Immunology, and Inflammation (J.D.C., M.R.D., A.J.P.), and the Departments of Pathology, Microbiology, and Immunology (M.R.D.), Vanderbilt University Medical Center, Nashville; Moderna, Cambridge, MA (H.B., B.L.); and the Departments of Epidemiology and Microbiology and Immunology, University of North Carolina at Chapel Hill, Chapel Hill (D.R.M., R.B.).""}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Albert', 'Affiliation': ""From the Center for Childhood Infections and Vaccines of Children's Healthcare of Atlanta and the Department of Pediatrics, Emory University School of Medicine (E.J.A., V.V.E., K.F., M.S.S., C.A.R.), and Emory Vaccine Center, Yerkes National Primate Research Center, Emory University (M.S.S.), Atlanta, and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (E.J.A., N.G.R., V.K.P.) - both in Georgia; the Vaccine Research Center (A.T.W., A.B.M., B.F., B.C.L., N.A.D.-R., S.O., S.D.S., K.S.C., P.A.S., M.P., J.E.L., B.S.G.) and the Division of Microbiology and Infectious Diseases (P.C.R., M. Makhene, W.B., C.J.L., J.H.B.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the University of Maryland School of Medicine, Baltimore (K.M.N.), and the Emmes Company, Rockville (M. Makowski, J.A., K.C.) - all in Maryland; Kaiser Permanente Washington Health Research Institute, Seattle (L.A.J.); the Department of Pediatrics (J.D.C., M.R.D., L.J.S., A.J.P.), the Vanderbilt Institute for Infection, Immunology, and Inflammation (J.D.C., M.R.D., A.J.P.), and the Departments of Pathology, Microbiology, and Immunology (M.R.D.), Vanderbilt University Medical Center, Nashville; Moderna, Cambridge, MA (H.B., B.L.); and the Departments of Epidemiology and Microbiology and Immunology, University of North Carolina at Chapel Hill, Chapel Hill (D.R.M., R.B.).""}, {'ForeName': 'Kaitlyn', 'Initials': 'K', 'LastName': 'Cross', 'Affiliation': ""From the Center for Childhood Infections and Vaccines of Children's Healthcare of Atlanta and the Department of Pediatrics, Emory University School of Medicine (E.J.A., V.V.E., K.F., M.S.S., C.A.R.), and Emory Vaccine Center, Yerkes National Primate Research Center, Emory University (M.S.S.), Atlanta, and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (E.J.A., N.G.R., V.K.P.) - both in Georgia; the Vaccine Research Center (A.T.W., A.B.M., B.F., B.C.L., N.A.D.-R., S.O., S.D.S., K.S.C., P.A.S., M.P., J.E.L., B.S.G.) and the Division of Microbiology and Infectious Diseases (P.C.R., M. Makhene, W.B., C.J.L., J.H.B.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the University of Maryland School of Medicine, Baltimore (K.M.N.), and the Emmes Company, Rockville (M. Makowski, J.A., K.C.) - all in Maryland; Kaiser Permanente Washington Health Research Institute, Seattle (L.A.J.); the Department of Pediatrics (J.D.C., M.R.D., L.J.S., A.J.P.), the Vanderbilt Institute for Infection, Immunology, and Inflammation (J.D.C., M.R.D., A.J.P.), and the Departments of Pathology, Microbiology, and Immunology (M.R.D.), Vanderbilt University Medical Center, Nashville; Moderna, Cambridge, MA (H.B., B.L.); and the Departments of Epidemiology and Microbiology and Immunology, University of North Carolina at Chapel Hill, Chapel Hill (D.R.M., R.B.).""}, {'ForeName': 'Venkata Viswanadh', 'Initials': 'VV', 'LastName': 'Edara', 'Affiliation': ""From the Center for Childhood Infections and Vaccines of Children's Healthcare of Atlanta and the Department of Pediatrics, Emory University School of Medicine (E.J.A., V.V.E., K.F., M.S.S., C.A.R.), and Emory Vaccine Center, Yerkes National Primate Research Center, Emory University (M.S.S.), Atlanta, and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (E.J.A., N.G.R., V.K.P.) - both in Georgia; the Vaccine Research Center (A.T.W., A.B.M., B.F., B.C.L., N.A.D.-R., S.O., S.D.S., K.S.C., P.A.S., M.P., J.E.L., B.S.G.) and the Division of Microbiology and Infectious Diseases (P.C.R., M. Makhene, W.B., C.J.L., J.H.B.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the University of Maryland School of Medicine, Baltimore (K.M.N.), and the Emmes Company, Rockville (M. Makowski, J.A., K.C.) - all in Maryland; Kaiser Permanente Washington Health Research Institute, Seattle (L.A.J.); the Department of Pediatrics (J.D.C., M.R.D., L.J.S., A.J.P.), the Vanderbilt Institute for Infection, Immunology, and Inflammation (J.D.C., M.R.D., A.J.P.), and the Departments of Pathology, Microbiology, and Immunology (M.R.D.), Vanderbilt University Medical Center, Nashville; Moderna, Cambridge, MA (H.B., B.L.); and the Departments of Epidemiology and Microbiology and Immunology, University of North Carolina at Chapel Hill, Chapel Hill (D.R.M., R.B.).""}, {'ForeName': 'Katharine', 'Initials': 'K', 'LastName': 'Floyd', 'Affiliation': ""From the Center for Childhood Infections and Vaccines of Children's Healthcare of Atlanta and the Department of Pediatrics, Emory University School of Medicine (E.J.A., V.V.E., K.F., M.S.S., C.A.R.), and Emory Vaccine Center, Yerkes National Primate Research Center, Emory University (M.S.S.), Atlanta, and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (E.J.A., N.G.R., V.K.P.) - both in Georgia; the Vaccine Research Center (A.T.W., A.B.M., B.F., B.C.L., N.A.D.-R., S.O., S.D.S., K.S.C., P.A.S., M.P., J.E.L., B.S.G.) and the Division of Microbiology and Infectious Diseases (P.C.R., M. Makhene, W.B., C.J.L., J.H.B.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the University of Maryland School of Medicine, Baltimore (K.M.N.), and the Emmes Company, Rockville (M. Makowski, J.A., K.C.) - all in Maryland; Kaiser Permanente Washington Health Research Institute, Seattle (L.A.J.); the Department of Pediatrics (J.D.C., M.R.D., L.J.S., A.J.P.), the Vanderbilt Institute for Infection, Immunology, and Inflammation (J.D.C., M.R.D., A.J.P.), and the Departments of Pathology, Microbiology, and Immunology (M.R.D.), Vanderbilt University Medical Center, Nashville; Moderna, Cambridge, MA (H.B., B.L.); and the Departments of Epidemiology and Microbiology and Immunology, University of North Carolina at Chapel Hill, Chapel Hill (D.R.M., R.B.).""}, {'ForeName': 'Mehul S', 'Initials': 'MS', 'LastName': 'Suthar', 'Affiliation': ""From the Center for Childhood Infections and Vaccines of Children's Healthcare of Atlanta and the Department of Pediatrics, Emory University School of Medicine (E.J.A., V.V.E., K.F., M.S.S., C.A.R.), and Emory Vaccine Center, Yerkes National Primate Research Center, Emory University (M.S.S.), Atlanta, and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (E.J.A., N.G.R., V.K.P.) - both in Georgia; the Vaccine Research Center (A.T.W., A.B.M., B.F., B.C.L., N.A.D.-R., S.O., S.D.S., K.S.C., P.A.S., M.P., J.E.L., B.S.G.) and the Division of Microbiology and Infectious Diseases (P.C.R., M. Makhene, W.B., C.J.L., J.H.B.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the University of Maryland School of Medicine, Baltimore (K.M.N.), and the Emmes Company, Rockville (M. Makowski, J.A., K.C.) - all in Maryland; Kaiser Permanente Washington Health Research Institute, Seattle (L.A.J.); the Department of Pediatrics (J.D.C., M.R.D., L.J.S., A.J.P.), the Vanderbilt Institute for Infection, Immunology, and Inflammation (J.D.C., M.R.D., A.J.P.), and the Departments of Pathology, Microbiology, and Immunology (M.R.D.), Vanderbilt University Medical Center, Nashville; Moderna, Cambridge, MA (H.B., B.L.); and the Departments of Epidemiology and Microbiology and Immunology, University of North Carolina at Chapel Hill, Chapel Hill (D.R.M., R.B.).""}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Martinez', 'Affiliation': ""From the Center for Childhood Infections and Vaccines of Children's Healthcare of Atlanta and the Department of Pediatrics, Emory University School of Medicine (E.J.A., V.V.E., K.F., M.S.S., C.A.R.), and Emory Vaccine Center, Yerkes National Primate Research Center, Emory University (M.S.S.), Atlanta, and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (E.J.A., N.G.R., V.K.P.) - both in Georgia; the Vaccine Research Center (A.T.W., A.B.M., B.F., B.C.L., N.A.D.-R., S.O., S.D.S., K.S.C., P.A.S., M.P., J.E.L., B.S.G.) and the Division of Microbiology and Infectious Diseases (P.C.R., M. Makhene, W.B., C.J.L., J.H.B.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the University of Maryland School of Medicine, Baltimore (K.M.N.), and the Emmes Company, Rockville (M. Makowski, J.A., K.C.) - all in Maryland; Kaiser Permanente Washington Health Research Institute, Seattle (L.A.J.); the Department of Pediatrics (J.D.C., M.R.D., L.J.S., A.J.P.), the Vanderbilt Institute for Infection, Immunology, and Inflammation (J.D.C., M.R.D., A.J.P.), and the Departments of Pathology, Microbiology, and Immunology (M.R.D.), Vanderbilt University Medical Center, Nashville; Moderna, Cambridge, MA (H.B., B.L.); and the Departments of Epidemiology and Microbiology and Immunology, University of North Carolina at Chapel Hill, Chapel Hill (D.R.M., R.B.).""}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Baric', 'Affiliation': ""From the Center for Childhood Infections and Vaccines of Children's Healthcare of Atlanta and the Department of Pediatrics, Emory University School of Medicine (E.J.A., V.V.E., K.F., M.S.S., C.A.R.), and Emory Vaccine Center, Yerkes National Primate Research Center, Emory University (M.S.S.), Atlanta, and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (E.J.A., N.G.R., V.K.P.) - both in Georgia; the Vaccine Research Center (A.T.W., A.B.M., B.F., B.C.L., N.A.D.-R., S.O., S.D.S., K.S.C., P.A.S., M.P., J.E.L., B.S.G.) and the Division of Microbiology and Infectious Diseases (P.C.R., M. Makhene, W.B., C.J.L., J.H.B.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the University of Maryland School of Medicine, Baltimore (K.M.N.), and the Emmes Company, Rockville (M. Makowski, J.A., K.C.) - all in Maryland; Kaiser Permanente Washington Health Research Institute, Seattle (L.A.J.); the Department of Pediatrics (J.D.C., M.R.D., L.J.S., A.J.P.), the Vanderbilt Institute for Infection, Immunology, and Inflammation (J.D.C., M.R.D., A.J.P.), and the Departments of Pathology, Microbiology, and Immunology (M.R.D.), Vanderbilt University Medical Center, Nashville; Moderna, Cambridge, MA (H.B., B.L.); and the Departments of Epidemiology and Microbiology and Immunology, University of North Carolina at Chapel Hill, Chapel Hill (D.R.M., R.B.).""}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Buchanan', 'Affiliation': ""From the Center for Childhood Infections and Vaccines of Children's Healthcare of Atlanta and the Department of Pediatrics, Emory University School of Medicine (E.J.A., V.V.E., K.F., M.S.S., C.A.R.), and Emory Vaccine Center, Yerkes National Primate Research Center, Emory University (M.S.S.), Atlanta, and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (E.J.A., N.G.R., V.K.P.) - both in Georgia; the Vaccine Research Center (A.T.W., A.B.M., B.F., B.C.L., N.A.D.-R., S.O., S.D.S., K.S.C., P.A.S., M.P., J.E.L., B.S.G.) and the Division of Microbiology and Infectious Diseases (P.C.R., M. Makhene, W.B., C.J.L., J.H.B.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the University of Maryland School of Medicine, Baltimore (K.M.N.), and the Emmes Company, Rockville (M. Makowski, J.A., K.C.) - all in Maryland; Kaiser Permanente Washington Health Research Institute, Seattle (L.A.J.); the Department of Pediatrics (J.D.C., M.R.D., L.J.S., A.J.P.), the Vanderbilt Institute for Infection, Immunology, and Inflammation (J.D.C., M.R.D., A.J.P.), and the Departments of Pathology, Microbiology, and Immunology (M.R.D.), Vanderbilt University Medical Center, Nashville; Moderna, Cambridge, MA (H.B., B.L.); and the Departments of Epidemiology and Microbiology and Immunology, University of North Carolina at Chapel Hill, Chapel Hill (D.R.M., R.B.).""}, {'ForeName': 'Catherine J', 'Initials': 'CJ', 'LastName': 'Luke', 'Affiliation': ""From the Center for Childhood Infections and Vaccines of Children's Healthcare of Atlanta and the Department of Pediatrics, Emory University School of Medicine (E.J.A., V.V.E., K.F., M.S.S., C.A.R.), and Emory Vaccine Center, Yerkes National Primate Research Center, Emory University (M.S.S.), Atlanta, and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (E.J.A., N.G.R., V.K.P.) - both in Georgia; the Vaccine Research Center (A.T.W., A.B.M., B.F., B.C.L., N.A.D.-R., S.O., S.D.S., K.S.C., P.A.S., M.P., J.E.L., B.S.G.) and the Division of Microbiology and Infectious Diseases (P.C.R., M. Makhene, W.B., C.J.L., J.H.B.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the University of Maryland School of Medicine, Baltimore (K.M.N.), and the Emmes Company, Rockville (M. Makowski, J.A., K.C.) - all in Maryland; Kaiser Permanente Washington Health Research Institute, Seattle (L.A.J.); the Department of Pediatrics (J.D.C., M.R.D., L.J.S., A.J.P.), the Vanderbilt Institute for Infection, Immunology, and Inflammation (J.D.C., M.R.D., A.J.P.), and the Departments of Pathology, Microbiology, and Immunology (M.R.D.), Vanderbilt University Medical Center, Nashville; Moderna, Cambridge, MA (H.B., B.L.); and the Departments of Epidemiology and Microbiology and Immunology, University of North Carolina at Chapel Hill, Chapel Hill (D.R.M., R.B.).""}, {'ForeName': 'Varun K', 'Initials': 'VK', 'LastName': 'Phadke', 'Affiliation': ""From the Center for Childhood Infections and Vaccines of Children's Healthcare of Atlanta and the Department of Pediatrics, Emory University School of Medicine (E.J.A., V.V.E., K.F., M.S.S., C.A.R.), and Emory Vaccine Center, Yerkes National Primate Research Center, Emory University (M.S.S.), Atlanta, and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (E.J.A., N.G.R., V.K.P.) - both in Georgia; the Vaccine Research Center (A.T.W., A.B.M., B.F., B.C.L., N.A.D.-R., S.O., S.D.S., K.S.C., P.A.S., M.P., J.E.L., B.S.G.) and the Division of Microbiology and Infectious Diseases (P.C.R., M. Makhene, W.B., C.J.L., J.H.B.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the University of Maryland School of Medicine, Baltimore (K.M.N.), and the Emmes Company, Rockville (M. Makowski, J.A., K.C.) - all in Maryland; Kaiser Permanente Washington Health Research Institute, Seattle (L.A.J.); the Department of Pediatrics (J.D.C., M.R.D., L.J.S., A.J.P.), the Vanderbilt Institute for Infection, Immunology, and Inflammation (J.D.C., M.R.D., A.J.P.), and the Departments of Pathology, Microbiology, and Immunology (M.R.D.), Vanderbilt University Medical Center, Nashville; Moderna, Cambridge, MA (H.B., B.L.); and the Departments of Epidemiology and Microbiology and Immunology, University of North Carolina at Chapel Hill, Chapel Hill (D.R.M., R.B.).""}, {'ForeName': 'Christina A', 'Initials': 'CA', 'LastName': 'Rostad', 'Affiliation': ""From the Center for Childhood Infections and Vaccines of Children's Healthcare of Atlanta and the Department of Pediatrics, Emory University School of Medicine (E.J.A., V.V.E., K.F., M.S.S., C.A.R.), and Emory Vaccine Center, Yerkes National Primate Research Center, Emory University (M.S.S.), Atlanta, and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (E.J.A., N.G.R., V.K.P.) - both in Georgia; the Vaccine Research Center (A.T.W., A.B.M., B.F., B.C.L., N.A.D.-R., S.O., S.D.S., K.S.C., P.A.S., M.P., J.E.L., B.S.G.) and the Division of Microbiology and Infectious Diseases (P.C.R., M. Makhene, W.B., C.J.L., J.H.B.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the University of Maryland School of Medicine, Baltimore (K.M.N.), and the Emmes Company, Rockville (M. Makowski, J.A., K.C.) - all in Maryland; Kaiser Permanente Washington Health Research Institute, Seattle (L.A.J.); the Department of Pediatrics (J.D.C., M.R.D., L.J.S., A.J.P.), the Vanderbilt Institute for Infection, Immunology, and Inflammation (J.D.C., M.R.D., A.J.P.), and the Departments of Pathology, Microbiology, and Immunology (M.R.D.), Vanderbilt University Medical Center, Nashville; Moderna, Cambridge, MA (H.B., B.L.); and the Departments of Epidemiology and Microbiology and Immunology, University of North Carolina at Chapel Hill, Chapel Hill (D.R.M., R.B.).""}, {'ForeName': 'Julie E', 'Initials': 'JE', 'LastName': 'Ledgerwood', 'Affiliation': ""From the Center for Childhood Infections and Vaccines of Children's Healthcare of Atlanta and the Department of Pediatrics, Emory University School of Medicine (E.J.A., V.V.E., K.F., M.S.S., C.A.R.), and Emory Vaccine Center, Yerkes National Primate Research Center, Emory University (M.S.S.), Atlanta, and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (E.J.A., N.G.R., V.K.P.) - both in Georgia; the Vaccine Research Center (A.T.W., A.B.M., B.F., B.C.L., N.A.D.-R., S.O., S.D.S., K.S.C., P.A.S., M.P., J.E.L., B.S.G.) and the Division of Microbiology and Infectious Diseases (P.C.R., M. Makhene, W.B., C.J.L., J.H.B.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the University of Maryland School of Medicine, Baltimore (K.M.N.), and the Emmes Company, Rockville (M. Makowski, J.A., K.C.) - all in Maryland; Kaiser Permanente Washington Health Research Institute, Seattle (L.A.J.); the Department of Pediatrics (J.D.C., M.R.D., L.J.S., A.J.P.), the Vanderbilt Institute for Infection, Immunology, and Inflammation (J.D.C., M.R.D., A.J.P.), and the Departments of Pathology, Microbiology, and Immunology (M.R.D.), Vanderbilt University Medical Center, Nashville; Moderna, Cambridge, MA (H.B., B.L.); and the Departments of Epidemiology and Microbiology and Immunology, University of North Carolina at Chapel Hill, Chapel Hill (D.R.M., R.B.).""}, {'ForeName': 'Barney S', 'Initials': 'BS', 'LastName': 'Graham', 'Affiliation': ""From the Center for Childhood Infections and Vaccines of Children's Healthcare of Atlanta and the Department of Pediatrics, Emory University School of Medicine (E.J.A., V.V.E., K.F., M.S.S., C.A.R.), and Emory Vaccine Center, Yerkes National Primate Research Center, Emory University (M.S.S.), Atlanta, and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (E.J.A., N.G.R., V.K.P.) - both in Georgia; the Vaccine Research Center (A.T.W., A.B.M., B.F., B.C.L., N.A.D.-R., S.O., S.D.S., K.S.C., P.A.S., M.P., J.E.L., B.S.G.) and the Division of Microbiology and Infectious Diseases (P.C.R., M. Makhene, W.B., C.J.L., J.H.B.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the University of Maryland School of Medicine, Baltimore (K.M.N.), and the Emmes Company, Rockville (M. Makowski, J.A., K.C.) - all in Maryland; Kaiser Permanente Washington Health Research Institute, Seattle (L.A.J.); the Department of Pediatrics (J.D.C., M.R.D., L.J.S., A.J.P.), the Vanderbilt Institute for Infection, Immunology, and Inflammation (J.D.C., M.R.D., A.J.P.), and the Departments of Pathology, Microbiology, and Immunology (M.R.D.), Vanderbilt University Medical Center, Nashville; Moderna, Cambridge, MA (H.B., B.L.); and the Departments of Epidemiology and Microbiology and Immunology, University of North Carolina at Chapel Hill, Chapel Hill (D.R.M., R.B.).""}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Beigel', 'Affiliation': ""From the Center for Childhood Infections and Vaccines of Children's Healthcare of Atlanta and the Department of Pediatrics, Emory University School of Medicine (E.J.A., V.V.E., K.F., M.S.S., C.A.R.), and Emory Vaccine Center, Yerkes National Primate Research Center, Emory University (M.S.S.), Atlanta, and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (E.J.A., N.G.R., V.K.P.) - both in Georgia; the Vaccine Research Center (A.T.W., A.B.M., B.F., B.C.L., N.A.D.-R., S.O., S.D.S., K.S.C., P.A.S., M.P., J.E.L., B.S.G.) and the Division of Microbiology and Infectious Diseases (P.C.R., M. Makhene, W.B., C.J.L., J.H.B.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the University of Maryland School of Medicine, Baltimore (K.M.N.), and the Emmes Company, Rockville (M. Makowski, J.A., K.C.) - all in Maryland; Kaiser Permanente Washington Health Research Institute, Seattle (L.A.J.); the Department of Pediatrics (J.D.C., M.R.D., L.J.S., A.J.P.), the Vanderbilt Institute for Infection, Immunology, and Inflammation (J.D.C., M.R.D., A.J.P.), and the Departments of Pathology, Microbiology, and Immunology (M.R.D.), Vanderbilt University Medical Center, Nashville; Moderna, Cambridge, MA (H.B., B.L.); and the Departments of Epidemiology and Microbiology and Immunology, University of North Carolina at Chapel Hill, Chapel Hill (D.R.M., R.B.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2028436']
3105,33004239,"DAR-901 vaccine for the prevention of infection with Mycobacterium tuberculosis among BCG-immunized adolescents in Tanzania: A randomized controlled, double-blind phase 2b trial.","BACKGROUND


SRL172 prevented disease due to Mycobacterium tuberculosis in a Phase 3 trial. DAR-901 represents a scalable manufacturing process for SRL172. We sought to determine if DAR-901 would prevent infection with M. tuberculosis among BCG-primed adolescents age 13-15 years in Tanzania.
METHODS


Adolescents with a negative T- SPOT.TB R  interferon gamma release assay (IGRA) were randomized 1:1 to three intradermal injections of DAR-901 or saline placebo at 0, 2 and 4 months. Repeat IGRAs were performed at 2 months, and at 1, 2, and 3 years. The primary efficacy outcome was time to new TB infection (IGRA conversion to positive); the secondary outcome was time to persistent TB infection (IGRA conversion with repeat positive IGRA).
RESULTS


Among 936 participants screened 667 were eligible and randomized to their first dose of vaccine or placebo (safety cohort). At 2 months, 625 participants remained IGRA-negative and were scheduled for the additional two doses (efficacy cohort). DAR-901 was safe and well-tolerated. One DAR-901 recipient developed a vaccine site abscess. Neither the primary nor secondary endpoints differed between the two treatment arms (p = 0.90 and p = 0.20, respectively). DAR-901 IGRA converters had median responses to ESAT-6 of 50.1 spot-forming cells (SFCs) vs. 19.6 SFCs in placebo IGRA converters (p = 0.03).
CONCLUSIONS


A three-dose series of 1 mg DAR-901 was safe and well-tolerated but did not prevent initial or persistent IGRA conversion. DAR-901 recipients with IGRA conversion demonstrated enhanced immune responses to ESAT-6. Since protection against disease may require different immunologic responses than protection against infection a trial of DAR-901 to prevent TB disease is warranted.
TRIAL REGISTRATION


The trial is registered at ClinicalTrials.gov as NCT02712424.",2020,"Neither the primary nor secondary endpoints differed between the two treatment arms (p = 0.90 and p = 0.20, respectively).","['BCG-immunized adolescents in Tanzania', '936 participants screened 667 were eligible and randomized to their first dose of', 'Adolescents with a negative T- SPOT.TB R  interferon gamma release assay (IGRA', 'BCG-primed adolescents age 13-15\xa0years in Tanzania', '625 participants remained IGRA-negative']","['DAR-901 or saline placebo', 'vaccine or placebo', 'IGRA', 'DAR-901', 'DAR-901 vaccine']","['safe and well-tolerated', 'time to new TB infection (IGRA conversion to positive); the secondary outcome was time to persistent TB infection (IGRA conversion with repeat positive IGRA']","[{'cui': 'C0004886', 'cui_str': 'BCG vaccine'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4517851', 'cui_str': '667'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C3178802', 'cui_str': 'Interferon gamma release assay'}, {'cui': 'C0331021', 'cui_str': 'Ligustrum vulgare'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517838', 'cui_str': '625'}]","[{'cui': 'C0022595', 'cui_str': 'Darier disease'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C3178802', 'cui_str': 'Interferon gamma release assay'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C3178802', 'cui_str': 'Interferon gamma release assay'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}]",,0.588273,"Neither the primary nor secondary endpoints differed between the two treatment arms (p = 0.90 and p = 0.20, respectively).","[{'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Munseri', 'Affiliation': 'Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Jamila', 'Initials': 'J', 'LastName': 'Said', 'Affiliation': 'Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Amour', 'Affiliation': 'Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Magohe', 'Affiliation': 'Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Mecky', 'Initials': 'M', 'LastName': 'Matee', 'Affiliation': 'Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Christiaan A', 'Initials': 'CA', 'LastName': 'Rees', 'Affiliation': 'Geisel School of Medicine at Dartmouth, Hanover, NH, USA.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Mackenzie', 'Affiliation': 'Geisel School of Medicine at Dartmouth, Hanover, NH, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Tvaroha', 'Affiliation': 'Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Bailey-Kellogg', 'Affiliation': 'Geisel School of Medicine at Dartmouth, Hanover, NH, USA.'}, {'ForeName': 'Isaac', 'Initials': 'I', 'LastName': 'Maro', 'Affiliation': 'Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Wieland-Alter', 'Affiliation': 'Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Lisa V', 'Initials': 'LV', 'LastName': 'Adams', 'Affiliation': 'Geisel School of Medicine at Dartmouth, Hanover, NH, USA.'}, {'ForeName': 'C Robert', 'Initials': 'CR', 'LastName': 'Horsburgh', 'Affiliation': 'Boston University School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Keiko', 'Initials': 'K', 'LastName': 'Nakamura', 'Affiliation': 'Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'Arbeit', 'Affiliation': 'Tufts University School of Medicine, Boston, MA, USA.'}, {'ForeName': 'Kisali', 'Initials': 'K', 'LastName': 'Pallangyo', 'Affiliation': 'Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'C Fordham', 'Initials': 'CF', 'LastName': 'von Reyn', 'Affiliation': 'Geisel School of Medicine at Dartmouth, Hanover, NH, USA. Electronic address: fvr@dartmouth.edu.'}]",Vaccine,['10.1016/j.vaccine.2020.09.055']
3106,33006062,"Efficacy and Safety of Ivabradine Once-Daily Prolonged-Release versus Twice-Daily Immediate-Release Formulation in Patients with Stable Chronic Heart Failure with Systolic Dysfunction: A Randomized, Double-Blind, Phase 3 Non-Inferiority (PROFICIENT) Study.","INTRODUCTION


Dosing frequency is an important factor influencing medication compliance in patients with heart failure (HF), which in turn is imperative in achieving the desired therapeutic outcome. Here we assessed the efficacy and safety of ivabradine prolonged-release (PR) once-daily (test) vs. ivabradine immediate-release (IR) twice-daily (reference) formulations in patients with stable chronic HF with systolic dysfunction.
METHODS


Patients with sinus rhythm and heart rate (HR) ≥ 50 bpm, left ventricular ejection fraction ≤ 40% (HF with reduced ejection fraction), on guideline-based standard care, receiving a stable dose of ivabradine IR 5/7.5 mg twice daily for ≥ 1 month were enrolled in this randomized, double-blind, phase 3 non-inferiority study. Patients were randomly assigned 1:1 to ivabradine PR (10 mg/15 mg) based on the ivabradine IR dosage or continued ivabradine IR (5 mg/7.5 mg). The primary endpoint was change in resting ECG HR from baseline to the end of 3 months, assessed by 12-lead ECG. Safety assessments and 24-h Holter HR monitoring (in a subgroup of patients) were also performed. Non-inferiority was concluded if the upper limit of the 95% CI of the difference between the test and reference was less than the margin of 6.5 bpm in the per-protocol set.
RESULTS


A total of 169 out of 180 randomized patients (93.9%) completed the study (PR = 84; IR = 85). The least-square mean (standard error [SE]) for change in HR from baseline to 3 months was 0.76 (1.188; 95% CI -1.59:3.11) in ivabradine PR vs. ivabradine IR, which was within the pre-specified margin of 6.5 bpm, confirming the non-inferiority of ivabradine PR. The change from baseline to 3 months was comparable between the treatment groups for 24-h Holter ECG monitoring (p = 0.3701), mean HR awake (p = 0.3423), and mean HR asleep (p = 0.1501). Thirty-nine treatment-emergent adverse events (TEAEs) were reported; the majority in both groups were of mild or moderate severity and were subsequently resolved. Seven serious adverse events were reported (ivabradine PR = 2; ivabradine IR = 5), of which one was fatal (ivabradine IR group). The bradycardia events reported were comparable between groups.
CONCLUSION


Ivabradine PR was found to be non-inferior to ivabradine IR in the management of patients with stable CHF, with a comparable safety profile. Once-daily ivabradine PR effectively maintained the HR in patients shifted from the ivabradine IR twice-daily regimen, and thus may aid in improving treatment compliance.
TRIAL REGISTRATION


CTRI/2018/04/013464 (Trial Registered Prospectively on 24/04/2018).",2020,"Ivabradine PR was found to be non-inferior to ivabradine IR in the management of patients with stable CHF, with a comparable safety profile.","['patients with heart failure (HF', 'patients with stable chronic HF with systolic dysfunction', 'Patients with Stable Chronic Heart Failure with Systolic Dysfunction', 'A total of 169 out of 180 randomized patients (93.9%) completed the study (PR\u2009=\u200984; IR\u2009=\u200985', 'Patients with sinus rhythm and heart rate (HR)\u2009≥\u200950\xa0bpm, left ventricular ejection fraction\u2009≤\u200940% (HF with reduced ejection fraction), on guideline-based standard care, receiving a stable dose of']","['Ivabradine Once-Daily Prolonged-Release versus Twice-Daily Immediate-Release Formulation', 'ivabradine prolonged-release (PR) once-daily (test) vs. ivabradine immediate-release (IR) twice-daily (reference) formulations', 'ivabradine IR 5/7.5\xa0mg twice daily for\u2009≥', 'ivabradine IR dosage or continued ivabradine IR', 'Ivabradine PR', 'ivabradine PR']","['efficacy and safety', 'Efficacy and Safety', 'mean HR asleep', 'bradycardia events', 'Safety assessments and 24-h Holter HR monitoring', 'change in resting ECG HR', 'Seven serious adverse events', 'mean HR awake']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0749225', 'cui_str': 'Systolic dysfunction'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0232201', 'cui_str': 'Sinus rhythm'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0439385', 'cui_str': 'beats/min'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0257190', 'cui_str': 'ivabradine'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C4544856', 'cui_str': 'Prolonged-release'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0424522', 'cui_str': 'Asleep'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0199637', 'cui_str': 'Cardiotachometry'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0234422', 'cui_str': 'Awake'}]",180.0,0.129954,"Ivabradine PR was found to be non-inferior to ivabradine IR in the management of patients with stable CHF, with a comparable safety profile.","[{'ForeName': 'Ajit', 'Initials': 'A', 'LastName': 'Mullasari', 'Affiliation': 'Madras Medical Mission, Mogappair, Chennai, Tamil Nadu, 300037, India. sulu_ajit57@yahoo.co.in.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Cardiology and therapy,['10.1007/s40119-020-00200-8']
3107,33016374,Rivastigmine in Parkinson's Disease Dementia with Orthostatic Hypotension.,"OBJECTIVE


The purpose of this study was to evaluate if the cognitive benefit of rivastigmine is affected by the presence of orthostatic hypotension (OH) in patients with Parkinson's disease dementia (PDD).
METHODS


We conducted a post hoc analysis on 1,047 patients with PDD from 2 randomized controlled trials comparing rivastigmine versus placebo at week 24 (n = 501) and rivastigmine patch versus capsule at week 76 (n = 546). A drop ≥ 20 mm Hg in systolic blood pressure (SBP) or ≥ 10 in diastolic blood pressure (DBP) upon standing classified subjects as OH positive (OH+); otherwise, OH negative (OH-). The primary end point was the Alzheimer's Disease Assessment Scale - Cognitive subscale (ADAS-Cog) at week 24 and the Mattis Dementia Rating Scale (MDRS) at week 76, using intention-to-treat with retrieved dropout at week 24 and observed cases at week 76, consistent with the original analyses.
RESULTS


Overall safety was comparable between OH+ (n = 288, 27.5%) and OH- (n = 730, 69.7%), except for higher frequency of syncope (9.2%) in the OH+ placebo arm. The placebo-adjusted effect of rivastigmine on ADAS-Cog at week 24 was 5.6 ± 1.2 for OH+ and 1.9 ± 0.9 in OH- (p = 0.0165). Among subjects with OH, the MDRS change from baseline at week 76 was higher for rivastigmine capsules versus patch (10.6 ± 2.9 vs -1.5 ± 3.0, p = 0.031). The overall prevalence of OH was lower for rivastigmine than placebo at week 24 (28.3% vs 44.6%, p = 0.0476).
INTERPRETATION


The cognitive benefit from rivastigmine is larger in patients with PDD with OH, possibly mediated by a direct antihypotensive effect. ANN NEUROL 2020.",2020,"The overall prevalence of OH+ was lower for rivastigmine than placebo at week 24 (28.3% vs 44.6%) (p = 0.0476).
","['PDD patients with OH', ""patients with Parkinson's disease dementia (PDD"", '1,047 PDD patients', ""Parkinson's Disease Dementia with Orthostatic Hypotension""]","['rivastigmine patch vs. capsule', 'placebo', 'rivastigmine vs. placebo', 'rivastigmine', 'Rivastigmine']","['Overall safety', 'frequency of syncope', 'MDRS change', ""Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog) at week 24 and the Mattis Dementia Rating Scale (MDRS"", 'orthostatic hypotension (OH', 'diastolic blood pressure', 'overall prevalence of OH']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020651', 'cui_str': 'Orthostatic hypotension'}]","[{'cui': 'C0649350', 'cui_str': 'rivastigmine'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0039070', 'cui_str': 'Syncope'}, {'cui': 'C0451074', 'cui_str': 'Clinical dementia rating scale'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0450989', 'cui_str': ""Alzheimer's Disease Assessment Scale""}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0020651', 'cui_str': 'Orthostatic hypotension'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}]",1047.0,0.312229,"The overall prevalence of OH+ was lower for rivastigmine than placebo at week 24 (28.3% vs 44.6%) (p = 0.0476).
","[{'ForeName': 'Alberto J', 'Initials': 'AJ', 'LastName': 'Espay', 'Affiliation': ""Gardner Family Center for Parkinson's Disease and Movement Disorders, Cincinnati, OH, USA.""}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Marsili', 'Affiliation': ""Gardner Family Center for Parkinson's Disease and Movement Disorders, Cincinnati, OH, USA.""}, {'ForeName': 'Abhimanyu', 'Initials': 'A', 'LastName': 'Mahajan', 'Affiliation': 'Section of Movement Disorders, Rush University Medical Center, Chicago, IL, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Sturchio', 'Affiliation': ""Gardner Family Center for Parkinson's Disease and Movement Disorders, Cincinnati, OH, USA.""}, {'ForeName': 'Rashidkhan', 'Initials': 'R', 'LastName': 'Pathan', 'Affiliation': 'Novartis Healthcare Private Limited, Hyderabad, India.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Pilotto', 'Affiliation': 'Neurology Unit, Department of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Damodaran S', 'Initials': 'DS', 'LastName': 'Elango', 'Affiliation': 'Novartis Healthcare Pvt Ltd., Hyderabad, India.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Pezous', 'Affiliation': 'Early Development Biostatistics, Novartis Pharma, Basel, Switzerland.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Masellis', 'Affiliation': 'Hurvitz Brain Sciences Program, Sunnybrook Research Institute, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Baltazar', 'Initials': 'B', 'LastName': 'Gomez-Mancilla', 'Affiliation': 'Neuroscience Translational Medicine, Novartis Institutes for Biomedical Research, Neurology, and Neurosurgery, McGill University, Montreal, Quebec, Canada.'}]",Annals of neurology,['10.1002/ana.25923']
3108,33017060,Vertical ridge augmentation (VRA) with Ti-reinforced d-PTFE membranes or Ti meshes and collagen membranes: 1-year results of a randomized clinical trial.,"OBJECTIVES


The aim of this study was to evaluate hard and soft tissues around implants placed in posterior mandible 1 year after vertical ridge augmentation (VRA).
MATERIALS AND METHODS


40 patients with vertical defects were enrolled and treated according to the study protocol. Patients were randomly divided into two study groups: reinforced PTFE membranes (group A) and titanium meshes plus collagen membranes (group B). All patients received simultaneous implants which were evaluated after prosthetic restoration at baseline and after 1 year, using the following parameters: peri-implant bone levels (PBLs), interproximal bone peaks (IBPs), pocket probing depth (PPD), bleeding on probing (BoP), plaque index (mPI), gingival index (mGI), keratinized tissue thickness/width (tKT and wKT), and fornix depth (FD). Statistical analysis was performed to investigate any statistically significant differences and/or correlations (p = .05).
RESULTS


30 patients were completely followed up according to the study protocol. After 1 year, implants showed a change in PBL from 0.12 to 0.76 mm, with marginal bone loss of 0.67 and 0.61 mm for group A and group B, respectively, without significant differences (p > .9337). The estimated difference between treatments for the change from baseline in PBL was -0.05 (95% CI -0.27 to 0.16). Statistical analysis revealed strong correlations between PBL and IBP (p < .0001). However, no significant differences were observed for PPD, mPI, mGI, tKT, wKT, and FD (p > .05).
CONCLUSION


The results indicate that GBR treatment with titanium meshes plus collagen membranes (Group B) compared to reinforced PTFE membranes does not appear to be inferior or superior in terms of PBL change. In both groups, hard and soft tissues were stable after 1 year of follow-up, with a peri-implant bone loss less than 1.0 mm in the first year (study registered at ClinicalTrials.gov NCT04332679).",2020,"However, no significant differences were observed for PPD, mPI, mGI, tKT, wKT, and FD (P>0.05).
","['40 patients with vertical defects were enrolled and treated according to the study protocol', '30 patients were completely followed-up according to the study protocol']","['Vertical ridge augmentation (VRA) with Ti-reinforced d-PTFE membranes or Ti-meshes and collagen membranes', 'vertical ridge augmentation (VRA', 'reinforced-PTFE membranes (group-A) and titanium-meshes plus collagen membranes']","['PBL', 'PPD, mPI, mGI, tKT, wKT, and FD (P>0.05', 'peri-implant-bone-levels (PBL), interproximal-bone-peaks (IBP), pocket-probing-depth (PPD), bleeding-on-probing (BoP), plaque-index(mPI), gingival-index(mGI), keratinized-tissue-thickness/width (tKT and wKT), and fornix-depth (FD', 'change of PBL', 'marginal bone loss']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C2599718', 'cui_str': 'Clinical Trial Protocols'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0332243', 'cui_str': 'Ridging'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0032611', 'cui_str': 'Polytetrafluoroethylene'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040302', 'cui_str': 'Titanium'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0663932', 'cui_str': 'SLPI protein, human'}, {'cui': 'C0152334', 'cui_str': 'Cerebral fornix structure'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}]",30.0,0.0929313,"However, no significant differences were observed for PPD, mPI, mGI, tKT, wKT, and FD (P>0.05).
","[{'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Cucchi', 'Affiliation': 'Unit of Oral and Maxillofacial Surgery, Department of Biomedical and Neuromotor Science (DIBINEM), Alma Mater Studiorum-University of Bologna, Bologna, Italy.'}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': 'Vignudelli', 'Affiliation': 'Unit of Oral and Maxillofacial Surgery, Department of Biomedical and Neuromotor Science (DIBINEM), Alma Mater Studiorum-University of Bologna, Bologna, Italy.'}, {'ForeName': 'Antonino', 'Initials': 'A', 'LastName': 'Fiorino', 'Affiliation': 'Catholic University of Sacred Heart, University Polyclinic Foundation A. Gemelli (IRCCS), Unit of Dentistry and Maxillofacial Surgery, Rome, Italy.'}, {'ForeName': 'Gerardo', 'Initials': 'G', 'LastName': 'Pellegrino', 'Affiliation': 'Unit of Oral and Maxillofacial Surgery, Department of Biomedical and Neuromotor Science (DIBINEM), Alma Mater Studiorum-University of Bologna, Bologna, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Corinaldesi', 'Affiliation': 'Unit of Preliminary Consultation, Risk Patients and Oral Pathology, Department of Biomedical and Neuromotor Sciences, Alma Mater Studiorum - University of Bologna, Bologna, Italy.'}]",Clinical oral implants research,['10.1111/clr.13673']
3109,33011188,The influence of linguistic information on cortical tracking of words.,"Speech is a complex sound sequence that has rich acoustic and linguistic structures. Recent studies have suggested that low-frequency cortical activity can track linguistic units in speech, such as words and phrases, on top of low-level acoustic features. Here, with an artificial word learning paradigm, we investigate how different aspects of linguistic information, e.g., phonological, semantic, and orthographic information, modulate cortical tracking of words. Participants are randomly assigned to the experimental group or the control group. Both groups listen to speech streams composed of trisyllabic artificial words or trisyllabic real words. Participants in the experimental group explicitly learn different types of linguistic information of artificial words (phonological, phonological + semantic, or phonological + orthographic information), while participants in the control group do not explicitly learn the words. Electroencephalographic (EEG) data from the control group reveal weaker cortical tracking of artificial words than real words. However, when comparing the experimental and control groups, we find that explicit learning significantly improves neural tracking of artificial words. After explicit learning, cortical tracking of artificial words is comparable to real words, regardless of the training conditions. These results suggest training facilitates neural tracking of words and emphasize the basic role phonological information played in sequential grouping.",2020,Electroencephalographic (EEG) data from the control group reveal weaker cortical tracking of artificial words than real words.,[],"['linguistic information of artificial words (phonological, phonological + semantic, or phonological + orthographic information), while participants in the control group do not explicitly learn the words', 'explicit learning']",['neural tracking of artificial words'],[],"[{'cui': 'C0023741', 'cui_str': 'Linguistics'}, {'cui': 'C2004457', 'cui_str': 'Artificial'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0036612', 'cui_str': 'Semantics'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C2004457', 'cui_str': 'Artificial'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}]",,0.0216826,Electroencephalographic (EEG) data from the control group reveal weaker cortical tracking of artificial words than real words.,"[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Key Laboratory for Biomedical Engineering of Ministry of Education, College of Biomedical Engineering and Instrument Sciences, Zhejiang University, Hangzhou, 310027, China.'}, {'ForeName': 'Peiqing', 'Initials': 'P', 'LastName': 'Jin', 'Affiliation': 'Key Laboratory for Biomedical Engineering of Ministry of Education, College of Biomedical Engineering and Instrument Sciences, Zhejiang University, Hangzhou, 310027, China.'}, {'ForeName': 'Nai', 'Initials': 'N', 'LastName': 'Ding', 'Affiliation': 'Key Laboratory for Biomedical Engineering of Ministry of Education, College of Biomedical Engineering and Instrument Sciences, Zhejiang University, Hangzhou, 310027, China; Research Center for Advanced Artificial Intelligence Theory, Zhejiang Lab, Hangzhou, 311121, China. Electronic address: ding_nai@zju.edu.cn.'}]",Neuropsychologia,['10.1016/j.neuropsychologia.2020.107640']
3110,33011207,Randomised trial of external-beam radiotherapy alone or with high-dose-rate brachytherapy for prostate cancer: Mature 12-year results.,"BACKGROUND AND PURPOSE


A randomised phase-III trial compared external beam radiotherapy (EBRT) alone with EBRT combined with high-dose-rate brachytherapy boost (HDR-BTb) in localised prostate adenocarcinoma. Previous analysis, at median follow up of 85 months, demonstrated improved relapse free survival (RFS) with EBRT + HDR-BTb. This data has now been updated with a median follow up of 131 months.
MATERIALS AND METHODS


From December 1997 to August 2005, patients were assigned either to EBRT alone delivering 55 Gy in 20 fractions over 4 weeks or EBRT followed by a temporary high-dose-rate implant delivering 2 × 8·5 Gy over 24 h. The primary endpoint was RFS defined by a PSA rise ≥2.0 µg/l above nadir, clinical progression or death. Actuarial survival rates and Hazard Ratios (HRs) were calculated using the Kaplan-Meier method and Cox's Proportional Hazard Model, respectively. Secondary endpoints were overall survival (OS), urinary and bowel toxicity.
RESULTS


One hundred and six patients received EBRT alone and 110 EBRT + HDR-BTb. Median time to relapse was 137 months in the HDR-BTb arm compared to 82 months for EBRT alone (p = 0·01). A 27% risk of recurrence with EBRT alone was observed (p = 0·001), resulting in a 21% improvement in RFS at 12 years with EBRT + HDR-BTb. In multivariate analysis treatment arm, risk category and no androgen deprivation therapy were significant covariates for risk of relapse. Differences in overall survival were not significant.
CONCLUSION


At 12 years there remains a significant improvement in RFS after EBRT + HDR-BTb; both treatments were equitoxic for severe late urinary and bowel events and urethral strictures.",2020,At 12 years there remains a significant improvement in RFS after EBRT + HDR-BTb; both treatments were equitoxic for severe late urinary and bowel events and urethral strictures.,"['localised prostate adenocarcinoma', 'prostate cancer', '106 patients received', 'From December 1997 to August 2005, patients']","['external beam radiotherapy (EBRT) alone with EBRT combined with high-dose-rate brachytherapy boost (HDR-BTb', 'EBRT alone delivering 55 Gy in 20 fractions over 4 weeks or EBRT followed by a temporary high-dose-rate implant delivering 2 x 8·5 Gy over 24h', 'EBRT alone and 110 EBRT+HDR-BTb', 'external-beam radiotherapy alone or with high-dose-rate brachytherapy']","['overall survival (OS), urinary and bowel toxicity', 'overall survival', 'RFS defined by a PSA rise ≥ 2.0µg/l above nadir, clinical progression or death', 'severe late urinary and bowel events and urethral strictures', 'relapse free survival (RFS', 'Actuarial survival rates and Hazard Ratios (HRs', 'Median time to relapse', 'RFS']","[{'cui': 'C0007112', 'cui_str': 'Adenocarcinoma of prostate'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0730225', 'cui_str': '1997'}]","[{'cui': 'C0419095', 'cui_str': 'Teleradiotherapy procedure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0454270', 'cui_str': 'High dose rate brachytherapy'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0205374', 'cui_str': 'Transitory'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0006098', 'cui_str': 'Brachytherapy'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0041974', 'cui_str': 'Urethral stenosis'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.0962728,At 12 years there remains a significant improvement in RFS after EBRT + HDR-BTb; both treatments were equitoxic for severe late urinary and bowel events and urethral strictures.,"[{'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Hoskin', 'Affiliation': 'Cancer Centre, Mount Vernon Hospital, Northwood, UK; University of Manchester, UK. Electronic address: peterhoskin@nhs.net.'}, {'ForeName': 'Ana M', 'Initials': 'AM', 'LastName': 'Rojas', 'Affiliation': 'Cancer Centre, Mount Vernon Hospital, Northwood, UK.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Ostler', 'Affiliation': 'Cancer Centre, Mount Vernon Hospital, Northwood, UK.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Bryant', 'Affiliation': 'Cancer Centre, Mount Vernon Hospital, Northwood, UK.'}, {'ForeName': 'Gerry J', 'Initials': 'GJ', 'LastName': 'Lowe', 'Affiliation': 'Cancer Centre, Mount Vernon Hospital, Northwood, UK.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2020.09.047']
3111,33027708,Delivery room skin-to-skin contact in preterm infants affects long-term expression of stress response genes.,"Premature birth is a traumatic event that puts mother and child at risk for subsequent psychopathology. Skin-to-skin contact in the form of intermittent kangaroo mother care has been shown to positively affect the infant's stress response and cognitive development, but underlying mechanisms remain unclear. Moreover, first skin-to-skin contact is usually delayed for days after birth. In the delivery room skin-to-skin study (DR-SSC), a prospective randomized controlled trial conducted from 2/2012 to 7/2015, we set out to assess the effect of delivery room skin-to-skin contact on the infant's mRNA expression of six key molecules involved in stress response and neurobehavioral development at hospital discharge. 88 firstborn, singleton preterm infants (born at 25-32 weeks of gestational age) were included. In the delivery room after initial stabilization, infants were randomized to either 60 min of skin-to-skin or 5 min of visual contact with their mother. In this explorative add-on study on the original DR-SSC study, we determined the expression of six important stress response genes (CRHR1 and CRHR2, AVP, NR3C1, HTR2A, and SLC6A4) in peripheral white blood cells of infants during routine blood sampling upon hospital discharge (corrected gestational age of 40 weeks). Infants were followed up to six months corrected age. Relative mRNA expression of the corticotropin releasing hormone receptor 2 (CRH R2), the glucocorticoid receptor gene (NR3C1), and the serotonin transporter gene (SLC6A4) was significantly reduced in the delivery room SSC infants. Additionally, gene expression of CRH R2 showed a correlation with HPA axis reactivity and parameters of mother-child interaction at six months corrected age. Our results highlight the importance of delivery room mother-child skin-to-skin contact and underline the urgent need for in-depth studies on the underlying molecular mechanisms.",2020,"Additionally, gene expression of CRH R2 showed a correlation with HPA axis reactivity and parameters of mother-child interaction at six months corrected age.","['peripheral white blood cells of infants during routine blood sampling upon hospital discharge (corrected gestational age of 40 weeks', 'preterm infants', '88 firstborn, singleton preterm infants (born at 25-32 weeks of gestational age']","['delivery room skin-to-skin contact', '60 min of skin-to-skin or 5 min of visual contact with their mother']","['HPA axis reactivity and parameters of mother-child interaction', 'expression of six important stress response genes (CRHR1 and CRHR2, AVP, NR3C1, HTR2A, and SLC6A4']","[{'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0005834', 'cui_str': 'Collection of blood specimen for laboratory'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}]","[{'cui': 'C0011212', 'cui_str': 'Delivery suite'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0026591', 'cui_str': 'Mother'}]","[{'cui': 'C0085355', 'cui_str': 'Platelet-specific antigen'}, {'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0026590', 'cui_str': 'Mother-Child Relationship'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0078039', 'cui_str': 'VAP combination'}, {'cui': 'C1370369', 'cui_str': 'NR3C1 protein, human'}, {'cui': 'C1456457', 'cui_str': 'SLC6A4 protein, human'}]",,0.0170859,"Additionally, gene expression of CRH R2 showed a correlation with HPA axis reactivity and parameters of mother-child interaction at six months corrected age.","[{'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Hucklenbruch-Rother', 'Affiliation': ""Metabolism and Perinatal Programming, Children's Hospital, University of Cologne, Cologne, Germany. Electronic address: eva.rother@uni-koeln.de.""}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Vohlen', 'Affiliation': ""Metabolism and Perinatal Programming, Children's Hospital, University of Cologne, Cologne, Germany.""}, {'ForeName': 'Nava', 'Initials': 'N', 'LastName': 'Mehdiani', 'Affiliation': ""Division of Neonatology, Children's Hospital, University of Cologne, Cologne, Germany.""}, {'ForeName': 'Titus', 'Initials': 'T', 'LastName': 'Keller', 'Affiliation': ""Division of Neonatology, Children's Hospital, University of Cologne, Cologne, Germany.""}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Roth', 'Affiliation': ""Division of Neonatology, Children's Hospital, University of Cologne, Cologne, Germany.""}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Kribs', 'Affiliation': ""Division of Neonatology, Children's Hospital, University of Cologne, Cologne, Germany.""}, {'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Mehler', 'Affiliation': ""Division of Neonatology, Children's Hospital, University of Cologne, Cologne, Germany.""}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104883']
3112,33027722,Hysteroscopic versus cervical injection for sentinel node detection in endometrial cancer: A multicenter prospective randomised controlled trial from the Multicenter Italian Trials in Ovarian cancer (MITO) study group.,"AIM


During the last years, the role of sentinel lymph node mapping (SLNM) for endometrial cancer (EC) surgical treatment has increased in popularity. However, several controversies remain about different technical steps of SLNM. Thus, a randomised control trial was designed to compare cervical (CI) and hysteroscopic (HI) indocyanine green (ICG) injection for SLNM of newly diagnosed EC undergoing surgical staging. The primary end-point of the study was to compare these two techniques in terms of para-aortic detection rate.
METHODS


Patients with apparent stage I or II histologically confirmed EC undergoing surgery were included in the study. This randomised trial distinguished patients in two study groups according to two different techniques of ICG SLNM: CI versus HI injection. Patients who met the inclusion criteria were randomly assigned to CI or HI injection in a 1:1 ratio. The central randomisation system allocated patient randomisation numbers sequentially in the order in which the patients were enrolled. This randomised trial was not blinded for either patients or the surgeons.
RESULTS


From March 2017 until April 2019, a total of 165 patients were randomised in this study: 85 (51.5%) in the CI group and 80 (48.5%) in the HI group. After randomisation, 14 (8.5%) patients were excluded from the study. Finally, 151 patients were included in the analysis: 82 (54.3%) in the CI group and 69 (45.7%) in the HI group. Hysteroscopy injection shows an ability to detect Sentinel nodes (SNLs) in the para-aortic area of about 10% greater compared with CI injection, although this difference did not reach statistical significance. The HI technique was superior in detecting isolated para-aortic SLNs (5.8% Versus 0%). The CI injection was correlated with higher SLN detection rates at the pelvic level compared with HI injection. Pelvic and overall detection was higher in the CI group.
CONCLUSIONS


The present study supports the adoption of CI instead of HI injection because the former allows better identification of sentinel nodes (especially in the pelvic area). Detection of SLN in the para-aortic area was slightly higher in patients receiving a HI injection, but the difference with the CI route was not statistically significant.",2020,The HI technique was superior in detecting isolated para-aortic SLNs (5.8% Versus 0%).,"['151 patients were included in the analysis: 82 (54.3%) in the CI group and 69 (45.7%) in the HI group', '165 patients', 'Patients who met the inclusion criteria', 'patients or the surgeons', 'From March 2017 until April 2019', 'Patients with apparent stage I or II histologically confirmed EC undergoing surgery were included in the study', 'endometrial cancer', 'newly diagnosed EC undergoing surgical staging']","['cervical (CI) and hysteroscopic (HI) indocyanine green (ICG) injection', 'sentinel lymph node mapping (SLNM', 'Hysteroscopic versus cervical injection', 'ICG\xa0SLNM: CI versus HI injection', 'CI or HI injection', 'Hysteroscopy injection']","['para-aortic detection rate', 'SLN detection rates', 'Pelvic and overall detection']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4319555', 'cui_str': '165'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0007103', 'cui_str': 'Endometrial neoplasms malignant'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0443276', 'cui_str': 'Pathological staging'}]","[{'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0021234', 'cui_str': 'Indocyanine Green'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C1519247', 'cui_str': 'Sentinel lymph node mapping'}, {'cui': 'C0020710', 'cui_str': 'Hysteroscopy'}]","[{'cui': 'C0442134', 'cui_str': 'Para-aortic'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C1522495', 'cui_str': 'Sentinal Node'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",165.0,0.181524,The HI technique was superior in detecting isolated para-aortic SLNs (5.8% Versus 0%).,"[{'ForeName': 'Antonino', 'Initials': 'A', 'LastName': 'Ditto', 'Affiliation': 'Department of Gynecologic Oncology, IRCCS National Cancer Institute, Milan, Italy. Electronic address: antonino.ditto@istitutotumori.mi.it.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Casarin', 'Affiliation': 'Academic Unit of Obstetrics and Gynaecology, Insubria University of Varese, Varese, Italy.'}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Perrone', 'Affiliation': ""Unit Gynaecologic Oncology, Sant'Orsola Malpighi of Bologna, Bologna, Italy.""}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Scollo', 'Affiliation': 'Unit of Obstetrics and Gynaecology, Cannizzaro Hospital of Catania, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Martinelli', 'Affiliation': 'Department of Gynecologic Oncology, IRCCS National Cancer Institute, Milan, Italy.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Bogani', 'Affiliation': 'Department of Gynecologic Oncology, IRCCS National Cancer Institute, Milan, Italy.'}, {'ForeName': 'Umberto L R', 'Initials': 'ULR', 'LastName': 'Maggiore', 'Affiliation': 'Department of Gynecologic Oncology, IRCCS National Cancer Institute, Milan, Italy.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Signorelli', 'Affiliation': 'Department of Gynecologic Oncology, IRCCS National Cancer Institute, Milan, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Chiappa', 'Affiliation': 'Department of Gynecologic Oncology, IRCCS National Cancer Institute, Milan, Italy.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Giorda', 'Affiliation': 'Department of Gynecologic Oncology, IRCCS CRO Oncologic Institute of Aviano, Aviano, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Scibilia', 'Affiliation': 'Unit of Obstetrics and Gynaecology, Cannizzaro Hospital of Catania, Italy.'}, {'ForeName': 'Pierandrea', 'Initials': 'P', 'LastName': 'De Iaco', 'Affiliation': ""Unit Gynaecologic Oncology, Sant'Orsola Malpighi of Bologna, Bologna, Italy.""}, {'ForeName': 'Mariateresa', 'Initials': 'M', 'LastName': 'Evangelista', 'Affiliation': 'Department of Gynecologic Oncology, IRCCS National Cancer Institute, Milan, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Ghezzi', 'Affiliation': 'Academic Unit of Obstetrics and Gynaecology, Insubria University of Varese, Varese, Italy.'}, {'ForeName': 'Biagio', 'Initials': 'B', 'LastName': 'Paolini', 'Affiliation': 'Department of Pathology, IRCCS National Cancer Institute, Milan, Italy.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Lo Vullo', 'Affiliation': 'Department of Gynecologic Oncology, IRCCS National Cancer Institute, Milan, Italy; Unit of Clinical Epidemiology and Trial Organization, IRCCS National Cancer Institute, Milan, Italy.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Mariani', 'Affiliation': 'Department of Gynecologic Oncology, IRCCS National Cancer Institute, Milan, Italy; Unit of Clinical Epidemiology and Trial Organization, IRCCS National Cancer Institute, Milan, Italy.'}, {'ForeName': 'Rosanna', 'Initials': 'R', 'LastName': 'Montone', 'Affiliation': 'Clinical Study Coordinator, Ufficio Operativo per la Ricerca Clinica - Clinical Trial Center Fondazione IRCCS Istituto Nazionale dei Tumori, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Raspagliesi', 'Affiliation': 'Department of Gynecologic Oncology, IRCCS National Cancer Institute, Milan, Italy.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.08.030']
3113,33027748,Renal protection with glucagon-like peptide-1 receptor agonists.,"There is an unmet need for renoprotective drugs for more pronounced reduction of albuminuria beyond that provided by renin-angiotensin system (RAS) blockers and for effective slowdown of eGFR decline independent of albuminuria. Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) have proven effective in reducing prespecified secondary composite kidney outcomes in cardiovascular outcome trials. However, GLP-1 RAs showed a prevailing anti-albuminuric effect, additional to that of RAS blockers, and a non-significant risk reduction in worsening of kidney function, at variance with sodium-glucose cotransporter 2 inhibitors. Mechanisms underlying renal protection with GLP-1 RAs are porly understood. Though treatment with GLP-1 RAs resulted in better glycaemic, blood pressure and body weight control versus placebo, correction for on-trial changes in these parameters did not significantly affect results. Anti-inflammatory/anti-oxidant effects via intracellular signalling through protein kinase A, natriuretic effect via inhibition of sodium-hydrogen exchanger 3 and reduction of hyperfiltration have been proposed as direct renoprotective effects.",2020,"Though treatment with GLP-1 RAs resulted in better glycaemic, blood pressure and body weight control versus placebo, correction for on-trial changes in these parameters did not significantly affect results.",[],"['Glucagon-like peptide-1 receptor agonists (GLP-1 RAs', 'GLP-1 RAs', 'glucagon-like peptide-1 receptor agonists']","['glycaemic, blood pressure and body weight control']",[],"[{'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",,0.0545075,"Though treatment with GLP-1 RAs resulted in better glycaemic, blood pressure and body weight control versus placebo, correction for on-trial changes in these parameters did not significantly affect results.","[{'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Vitale', 'Affiliation': 'Department of Clinical and Molecular Medicine, ""La Sapienza"" University, and Endocrine and Metabolic Unit, Sant\'Andrea University Hospital, Rome, Italy.'}, {'ForeName': 'Jonida', 'Initials': 'J', 'LastName': 'Haxhi', 'Affiliation': 'Department of Clinical and Molecular Medicine, ""La Sapienza"" University, and Endocrine and Metabolic Unit, Sant\'Andrea University Hospital, Rome, Italy.'}, {'ForeName': 'Tiziana', 'Initials': 'T', 'LastName': 'Cirrito', 'Affiliation': 'Department of Clinical and Molecular Medicine, ""La Sapienza"" University, and Endocrine and Metabolic Unit, Sant\'Andrea University Hospital, Rome, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Pugliese', 'Affiliation': 'Department of Clinical and Molecular Medicine, ""La Sapienza"" University, and Endocrine and Metabolic Unit, Sant\'Andrea University Hospital, Rome, Italy. Electronic address: giuseppe.pugliese@uniroma1.it.'}]",Current opinion in pharmacology,['10.1016/j.coph.2020.08.018']
3114,33028559,Hydrocolloid dressing as a prophylactic use for hand-foot skin reaction induced by multitargeted kinase inhibitors: protocol of a phase 3 randomised self-controlled study.,"INTRODUCTION


Although topical use of moisturisers is slightly effective for the prevention and avoiding the aggravation of hand-foot syndrome induced by multikinase inhibitors, there is still room for improvement. Hydrocolloid dressing is a type of wound dressing often used for wounds such as decubitus ulcers. The purpose of this study is to verify the usefulness of application of hydrocolloid dressings as prophylaxis against development of hand-foot syndrome induced by multikinase inhibitors by comparing the effects of this dressing and standard supportive care (moisturising care alone) within the same individuals.
METHODS


This study is a phase 3 randomised, self-controlled study to compare prophylactic moisturising care with or without hydrocolloid dressing for hand-foot syndrome induced by multikinase inhibitors. Patients with radically unresectable advanced or recurrent colorectal carcinoma, gastrointestinal stromal tumour and hepatocellular carcinoma who scheduled to receive regorafenib or sorafenib therapy are eligible for enrolment.Supportive care for hand-foot syndrome will consist of basic moisturising care with or without hydrocolloid dressing. If hand-foot syndrome occurs, a steroid ointment will be applied two times per day at the affected sites. The primary endpoint is an incidence rate of grade 2 or more severe hand-foot syndrome (soles of the feet only) assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events V.4.0. Grading of hand-foot syndrome will be performed by central review using photographs taken weekly by blinded trained physicians. The ethical approval was obtained from National Cancer Center Hospital. The results of this study will be submitted for publication in international peer-reviewed journals and the key findings will be presented at international scientific conference.
DISCUSSION


If the positive results are found in this study, it is shown that hydrocolloid dressing is effective not only as a symptom management but also as a prevention in hand-foot syndrome induced by multikinase.
TRIAL STATUS


The enrolment was started in January 2019, and planned to closed in January 2021. As of February 2020, 26 patients enrolled in this study.
TRIAL REGISTRATION NUMBER


UMIN Clinical Trial Registry (UMIN000034853).
PROTOCOL VERSION


V.1.4, 9 January 2020.",2020,"Although topical use of moisturisers is slightly effective for the prevention and avoiding the aggravation of hand-foot syndrome induced by multikinase inhibitors, there is still room for improvement.","['for hand-foot syndrome induced by multikinase inhibitors', 'VERSION\n\n\nV.1.4, 9 January 2020', 'February 2020, 26 patients enrolled in this study', 'Patients with radically unresectable advanced or recurrent colorectal carcinoma, gastrointestinal stromal tumour and hepatocellular carcinoma who scheduled to receive']","['Hydrocolloid dressing', 'hydrocolloid dressing', 'regorafenib or sorafenib therapy', 'hydrocolloid dressings', 'prophylactic moisturising care with or without hydrocolloid dressing']",['incidence rate of grade 2 or more severe hand-foot syndrome (soles of the feet only) assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events V.4.0'],"[{'cui': 'C0549410', 'cui_str': 'Palmar-plantar erythrodysaesthesia syndrome'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0854750', 'cui_str': 'Colorectal cancer recurrent'}, {'cui': 'C0238198', 'cui_str': 'Gastrointestinal stromal tumor'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}]","[{'cui': 'C0122734', 'cui_str': 'Hydrocolloid dressing'}, {'cui': 'C2980094', 'cui_str': 'regorafenib'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009653', 'cui_str': 'Condom'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0549410', 'cui_str': 'Palmar-plantar erythrodysaesthesia syndrome'}, {'cui': 'C0205208', 'cui_str': 'Solid'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C1513882', 'cui_str': 'National Cancer Institute'}, {'cui': 'C1516728', 'cui_str': 'National Cancer Institute common terminology criteria for adverse events'}]",26.0,0.0356922,"Although topical use of moisturisers is slightly effective for the prevention and avoiding the aggravation of hand-foot syndrome induced by multikinase inhibitors, there is still room for improvement.","[{'ForeName': 'Sadamoto', 'Initials': 'S', 'LastName': 'Zenda', 'Affiliation': 'Radiation Oncology, National Cancer Center Hospital East, Chiba, Japan szenda@east.ncc.go.jp.'}, {'ForeName': 'Asako', 'Initials': 'A', 'LastName': 'Ryu', 'Affiliation': 'Department of Nursing, National Cancer Center Hospital, Chuo-ku, Tokyo, Japan.'}, {'ForeName': 'Atsuo', 'Initials': 'A', 'LastName': 'Takashima', 'Affiliation': 'Department of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Chuo-ku, Tokyo, Japan.'}, {'ForeName': 'Michiko', 'Initials': 'M', 'LastName': 'Arai', 'Affiliation': 'Department of Nursing, National Cancer Center Hospital, Chuo-ku, Tokyo, Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Takagi', 'Affiliation': 'Department of Palliative Medicine, Teikyo University School of Medicine Graduate School of Medicine, Itabashi-ku, Tokyo, Japan.'}, {'ForeName': 'Tempei', 'Initials': 'T', 'LastName': 'Miyaji', 'Affiliation': 'Innovation Center for Supportive, Palliative and Psychosocial Care, National Cancer Center Hospital, & Behavioral and Survivorship Research Group, Center for Public Health Sciences, Tokyo, Japan.'}, {'ForeName': 'Tomoe', 'Initials': 'T', 'LastName': 'Mashiko', 'Affiliation': 'Innovation Center for Supportive, Palliative and Psychosocial Care, National Cancer Center Hospital, & Behavioral and Survivorship Research Group, Center for Public Health Sciences, Tokyo, Japan.'}, {'ForeName': 'Yoichi', 'Initials': 'Y', 'LastName': 'Shimizu', 'Affiliation': 'Department of Nursing, National Cancer Center Hospital, Chuo-ku, Tokyo, Japan.'}, {'ForeName': 'Naoya', 'Initials': 'N', 'LastName': 'Yamazaki', 'Affiliation': 'Department of Dermatologic Oncology, National Cancer Center Hospital, Chuo-ku, Tokyo, Japan.'}, {'ForeName': 'Chigusa', 'Initials': 'C', 'LastName': 'Morizane', 'Affiliation': 'Department of Hepatobiliary and Pancreatic Oncology Division, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Takuhiro', 'Initials': 'T', 'LastName': 'Yamaguchi', 'Affiliation': 'Department of Clinical Trial Data Management, Graduate School of Medicine, The University of Tokyo, Bunkyo-ku, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Kawaguchi', 'Affiliation': 'Department of Practical Pharmacy, Tokyo University of Pharmacy and Life Sciences, Tokyo, Japan.'}, {'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Hanai', 'Affiliation': 'Innovation Center for Supportive, Palliative and Psychosocial Care, National Cancer Center Hospital, & Behavioral and Survivorship Research Group, Center for Public Health Sciences, Tokyo, Japan.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Uchitomi', 'Affiliation': 'Innovation Center for Supportive, Palliative and Psychosocial Care, National Cancer Center Hospital, & Behavioral and Survivorship Research Group, Center for Public Health Sciences, Tokyo, Japan.'}, {'ForeName': 'Fukuko', 'Initials': 'F', 'LastName': 'Oshiba', 'Affiliation': 'Department of Nursing, National Cancer Center Hospital, Chuo-ku, Tokyo, Japan.'}]",BMJ open,['10.1136/bmjopen-2020-038276']
3115,33028560,"Effect of joint transition visits on quality of life in adolescents with inflammatory bowel diseases: a protocol for a prospective, randomised, multicentre, controlled trial (TRANS-IBD).","INTRODUCTION


Inflammatory bowel diseases (IBD) are among the most common chronic illnesses diagnosed in childhood. Transition from paediatric to adult care is a crucial phase. The implementation of joint visits during the transition period in IBD is widely recommended, however, strong evidence supporting their benefit is still missing. In this trial, we aim to prove the superiority of joint visits compared with usual care in improving transition outcomes of adolescents with IBD.
METHODS AND ANALYSIS


This is a randomised controlled two-arm multicentre trial. A minimum of 160 adolescents with IBD aged between 16.75 and 17 years will be recruited from Hungarian tertiary IBD centres. After randomisation, eligible subjects in the intervention arm attend a total of four joint visits with adult and paediatric gastroenterologist between the ages of 17 and 18. In the control arm, adolescents meet only the paediatric gastroenterologist, but there is a balanced consultation between the two gastroenterologist regarding the patient's treatment plan. Patients in both groups receive the same training and education, the only determinative difference between the two arms is the presence of the adult gastroenterologist at the joint visits. Data will be collected at inclusion, at transfer and 12 months post-transfer. Primary outcome is the change in health-related quality of life measured with the IMPACT-III questionnaire at 1 year after transfer. Secondary outcomes include the number of patients not lost to follow-up, healthcare utilisation, disease activity, medication adherence, self-efficacy, transition readiness and patient's satisfaction. To compare the results of the two patient groups, two-sample T-test and Mann-Whitney test will be applied.
ETHICS AND DISSEMINATION


The Scientific and Research Ethics Committee of the Hungarian Medical Research Council approved this study (50457-2/2019/EKU). Findings will be disseminated at conferences and in medical journals.
TRIAL REGISTRATION NUMBER


NCT04290156.",2020,"Secondary outcomes include the number of patients not lost to follow-up, healthcare utilisation, disease activity, medication adherence, self-efficacy, transition readiness and patient's satisfaction.","['160 adolescents with IBD aged between 16.75 and 17 years will be recruited from Hungarian tertiary IBD centres', 'eligible subjects in the intervention arm attend a total of four joint visits with adult and paediatric gastroenterologist between the ages of 17 and 18', 'adolescents with IBD', 'adolescents with inflammatory bowel diseases']","['joint transition visits', 'usual care']","[""number of patients not lost to follow-up, healthcare utilisation, disease activity, medication adherence, self-efficacy, transition readiness and patient's satisfaction"", 'quality of life', 'change in health-related quality of life measured with the IMPACT-III questionnaire at 1\u2009year after transfer']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory bowel disease'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0020173', 'cui_str': 'Hungarian language'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0586844', 'cui_str': 'Pediatric gastroenterologist'}]","[{'cui': 'C0022417', 'cui_str': 'Joint structure'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1302313', 'cui_str': 'Lost to follow-up'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}]",,0.174666,"Secondary outcomes include the number of patients not lost to follow-up, healthcare utilisation, disease activity, medication adherence, self-efficacy, transition readiness and patient's satisfaction.","[{'ForeName': 'Adrienn', 'Initials': 'A', 'LastName': 'Erős', 'Affiliation': 'Institute for Translational Medicine, Medical School, University of Pécs, Pécs, Hungary.'}, {'ForeName': 'Dóra', 'Initials': 'D', 'LastName': 'Dohos', 'Affiliation': 'Institute for Translational Medicine, Medical School, University of Pécs, Pécs, Hungary.'}, {'ForeName': 'Gábor', 'Initials': 'G', 'LastName': 'Veres', 'Affiliation': 'First Department of Pediatrics, University of Debrecen, Hungary, Debrecen, Hungary.'}, {'ForeName': 'András', 'Initials': 'A', 'LastName': 'Tárnok', 'Affiliation': 'Department of Pediatrics, Medical School, University of Pécs, Pécs, Hungary.'}, {'ForeName': 'Áron', 'Initials': 'Á', 'LastName': 'Vincze', 'Affiliation': 'First Department of Medicine, Medical School, University of Pécs, Pécs, Hungary, Pécs, Hungary.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Tészás', 'Affiliation': 'Department of Pediatrics, Medical School, University of Pécs, Pécs, Hungary.'}, {'ForeName': 'Noémi', 'Initials': 'N', 'LastName': 'Zádori', 'Affiliation': 'Institute for Translational Medicine, Medical School, University of Pécs, Pécs, Hungary.'}, {'ForeName': 'Noémi', 'Initials': 'N', 'LastName': 'Gede', 'Affiliation': 'Institute for Translational Medicine, Medical School, University of Pécs, Pécs, Hungary.'}, {'ForeName': 'Péter', 'Initials': 'P', 'LastName': 'Hegyi', 'Affiliation': 'Institute for Translational Medicine, Medical School, University of Pécs, Pécs, Hungary.'}, {'ForeName': 'Patrícia', 'Initials': 'P', 'LastName': 'Sarlós', 'Affiliation': 'Institute for Translational Medicine, Medical School, University of Pécs, Pécs, Hungary sarlosp@gmail.com.'}]",BMJ open,['10.1136/bmjopen-2020-038410']
3116,33028566,"Study protocol: azithromycin therapy for chronic lung disease of prematurity (AZTEC) - a randomised, placebo-controlled trial of azithromycin for the prevention of chronic lung disease of prematurity in preterm infants.","INTRODUCTION


Chronic lung disease of prematurity (CLD), also known as bronchopulmonary dysplasia (BPD), is a cause of significant respiratory morbidity in childhood and beyond. Coupled with lung immaturity, infections (especially by  Ureaplasma  spp) are implicated in the pathogenesis of CLD through promotion of pulmonary inflammation. Azithromycin, which is a highly effective against  Ureaplasma  spp also has potent anti-inflammatory properties. Thus, azithromycin therapy may improve respiratory outcomes by targeting infective and inflammatory pathways. Previous trials using macrolides have not been sufficiently powered to definitively assess CLD rates. To address this, the azithromycin therapy for chronic lung disease of prematurity (AZTEC) trial aims to determine if a 10-day early course of intravenous azithromycin improves rates of survival without CLD when compared with placebo with an appropriately powered study.
METHODS AND ANALYSIS


796 infants born at less than 30 weeks' gestational age who require at least 2 hours of continuous respiratory support within the first 72 hours following birth are being enrolled by neonatal units in the UK. They are being randomised to receive a double-blind, once daily dose of intravenous azithromycin (20 mg/kg for 3 days, followed by 10 mg/kg for a further 7 days), or placebo. CLD is being assessed at 36 weeks' PMA. Whether colonisation with  Ureaplasma  spp prior to randomisation modifies the treatment effect of azithromycin compared with placebo will also be investigated. Secondary outcomes include necrotising enterocolitis, intraventricular/cerebral haemorrhage, retinopathy of prematurity and nosocomial infections, development of antibiotic resistance and adverse reactions will be monitored.
ETHICS AND DISSEMINATION


Ethics permission has been granted by Wales Research Ethics Committee 2 (Ref 18/WA/0199), and regulatory permission by the Medicines and Healthcare Products Regulatory Agency (Clinical Trials Authorisation reference 21323/0050/001-0001). The study is registered on ISRCTN (ISRCTN11650227). The study is overseen by an independent Data Monitoring Committee and an independent Trial Steering Committee. We shall disseminate our findings via national and international peer-reviewed journals, and conferences. A summary of the findings will also be posted on the trial website.",2020,Whether colonisation with  Ureaplasma  spp prior to randomisation modifies the treatment effect of azithromycin compared with placebo will also be investigated.,"['chronic lung disease of prematurity (AZTEC', ""796 infants born at less than 30 weeks' gestational age who require at least 2 hours of continuous respiratory support within the first 72 hours following birth are being enrolled by neonatal units in the UK"", 'chronic lung disease of prematurity in preterm infants']","['Azithromycin', 'placebo', 'azithromycin', 'azithromycin therapy']","['necrotising enterocolitis, intraventricular/cerebral haemorrhage, retinopathy of prematurity and nosocomial infections, development of antibiotic resistance and adverse reactions', 'rates of survival without CLD']","[{'cui': 'C0006287', 'cui_str': 'Bronchopulmonary dysplasia of newborn'}, {'cui': 'C0337878', 'cui_str': 'Aztec'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C1292425', 'cui_str': '2 hours'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C1292423', 'cui_str': '72 hours'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0014356', 'cui_str': 'Enterocolitis'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0035344', 'cui_str': 'Retinopathy of prematurity'}, {'cui': 'C0010356', 'cui_str': 'Cross infection'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0949285', 'cui_str': 'Antibiotic Resistance'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0006287', 'cui_str': 'Bronchopulmonary dysplasia of newborn'}]",796.0,0.628621,Whether colonisation with  Ureaplasma  spp prior to randomisation modifies the treatment effect of azithromycin compared with placebo will also be investigated.,"[{'ForeName': 'John', 'Initials': 'J', 'LastName': 'Lowe', 'Affiliation': 'Centre for Trials Research, College of Biomedical and Life Sciences, Cardiff University, Cardiff, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Gillespie', 'Affiliation': 'Centre for Trials Research, College of Biomedical and Life Sciences, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Hubbard', 'Affiliation': 'Neonatal Intensive Care Unit, University Hospitals of Leicester NHS Trust, Leicester, Leicester, UK.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Child Health, School of Medicine, Cardiff University, Cardiff, United Kingdom.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Kirby', 'Affiliation': 'Centre for Trials Research, College of Biomedical and Life Sciences, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Pickles', 'Affiliation': 'Centre for Trials Research, College of Biomedical and Life Sciences, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Thomas-Jones', 'Affiliation': 'Centre for Trials Research, College of Biomedical and Life Sciences, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Turner', 'Affiliation': 'Institute of Translational Medicine, University of Liverpool, Liverpool, United Kingdom.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Klein', 'Affiliation': 'GOS Institute of Child Health, University College London, London, London, UK.'}, {'ForeName': 'Julian R', 'Initials': 'JR', 'LastName': 'Marchesi', 'Affiliation': 'School of Biosciences, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Kerenza', 'Initials': 'K', 'LastName': 'Hood', 'Affiliation': 'Centre for Trials Research, College of Biomedical and Life Sciences, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Berrington', 'Affiliation': 'Neonatal Intensive Care Unit, Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle Upon Tyne, UK.'}, {'ForeName': 'Sailesh', 'Initials': 'S', 'LastName': 'Kotecha', 'Affiliation': 'Department of Child Health, School of Medicine, Cardiff University, Cardiff, United Kingdom KotechaS@cardiff.ac.uk.'}]",BMJ open,['10.1136/bmjopen-2020-041528']
3117,33028588,Effect of exercise training for five years on all cause mortality in older adults-the Generation 100 study: randomised controlled trial.,"OBJECTIVE


To evaluate the effect of five years of supervised exercise training compared with recommendations for physical activity on mortality in older adults (70-77 years).
DESIGN


Randomised controlled trial.
SETTING


General population of older adults in Trondheim, Norway.
PARTICIPANTS


1567 of 6966 individuals born between 1936 and 1942.
INTERVENTION


Participants were randomised to two sessions weekly of high intensity interval training at about 90% of peak heart rate (HIIT, n=400), moderate intensity continuous training at about 70% of peak heart rate (MICT, n=387), or to follow the national guidelines for physical activity (n=780; control group); all for five years.
MAIN OUTCOME MEASURE


All cause mortality. An exploratory hypothesis was that HIIT lowers mortality more than MICT.
RESULTS


Mean age of the 1567 participants (790 women) was 72.8 (SD 2.1) years. Overall, 87.5% of participants reported to have overall good health, with 80% reporting medium or high physical activity levels at baseline. All cause mortality did not differ between the control group and combined MICT and HIIT group. When MICT and HIIT were analysed separately, with the control group as reference (observed mortality of 4.7%), an absolute risk reduction of 1.7 percentage points was observed after HIIT (hazard ratio 0.63, 95% confidence interval 0.33 to 1.20) and an absolute increased risk of 1.2 percentage points after MICT (1.24, 0.73 to 2.10). When HIIT was compared with MICT as reference group an absolute risk reduction of 2.9 percentage points was observed (0.51, 0.25 to 1.02) for all cause mortality. Control participants chose to perform more of their physical activity as HIIT than the physical activity undertaken by participants in the MICT group. This meant that the controls achieved an exercise dose at an intensity between the MICT and HIIT groups.
CONCLUSION


This study suggests that combined MICT and HIIT has no effect on all cause mortality compared with recommended physical activity levels. However, we observed a lower all cause mortality trend after HIIT compared with controls and MICT.
TRIAL REGISTRATION


ClinicalTrials.gov NCT01666340.",2020,All cause mortality did not differ between the control group and combined MICT and HIIT group.,"['older adults (70-77 years', 'General population of older adults in Trondheim, Norway', 'Mean age of the 1567 participants (790 women) was 72.8 (SD 2.1) years', 'older adults-the Generation 100 study', '1567 of 6966 individuals born between 1936 and 1942']","['MICT', 'high intensity interval training at about 90% of peak heart rate (HIIT, n=400), moderate intensity continuous training at about 70% of peak heart rate (MICT, n=387), or to follow the national guidelines for physical activity', 'supervised exercise training', 'exercise training']","['cause mortality', 'All cause mortality', 'physical activity levels', 'absolute risk reduction']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0028423', 'cui_str': 'Norway'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4068876', 'cui_str': '2.1'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}]","[{'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C3179139', 'cui_str': 'Absolute Risk Reduction'}]",6966.0,0.155157,All cause mortality did not differ between the control group and combined MICT and HIIT group.,"[{'ForeName': 'Dorthe', 'Initials': 'D', 'LastName': 'Stensvold', 'Affiliation': 'Department of Circulation and Medical Imaging, Faculty of Medicine and Health Sciences, NTNU-Norwegian University of Science and Technology, Post Box 8905, 7491 Trondheim, Norway.'}, {'ForeName': 'Hallgeir', 'Initials': 'H', 'LastName': 'Viken', 'Affiliation': 'Department of Circulation and Medical Imaging, Faculty of Medicine and Health Sciences, NTNU-Norwegian University of Science and Technology, Post Box 8905, 7491 Trondheim, Norway.'}, {'ForeName': 'Sigurd L', 'Initials': 'SL', 'LastName': 'Steinshamn', 'Affiliation': 'Department of Circulation and Medical Imaging, Faculty of Medicine and Health Sciences, NTNU-Norwegian University of Science and Technology, Post Box 8905, 7491 Trondheim, Norway.'}, {'ForeName': 'Håvard', 'Initials': 'H', 'LastName': 'Dalen', 'Affiliation': 'Department of Circulation and Medical Imaging, Faculty of Medicine and Health Sciences, NTNU-Norwegian University of Science and Technology, Post Box 8905, 7491 Trondheim, Norway.'}, {'ForeName': 'Asbjørn', 'Initials': 'A', 'LastName': 'Støylen', 'Affiliation': 'Department of Circulation and Medical Imaging, Faculty of Medicine and Health Sciences, NTNU-Norwegian University of Science and Technology, Post Box 8905, 7491 Trondheim, Norway.'}, {'ForeName': 'Jan P', 'Initials': 'JP', 'LastName': 'Loennechen', 'Affiliation': 'Department of Circulation and Medical Imaging, Faculty of Medicine and Health Sciences, NTNU-Norwegian University of Science and Technology, Post Box 8905, 7491 Trondheim, Norway.'}, {'ForeName': 'Line S', 'Initials': 'LS', 'LastName': 'Reitlo', 'Affiliation': 'Department of Circulation and Medical Imaging, Faculty of Medicine and Health Sciences, NTNU-Norwegian University of Science and Technology, Post Box 8905, 7491 Trondheim, Norway.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Zisko', 'Affiliation': 'Department of Circulation and Medical Imaging, Faculty of Medicine and Health Sciences, NTNU-Norwegian University of Science and Technology, Post Box 8905, 7491 Trondheim, Norway.'}, {'ForeName': 'Fredrik H', 'Initials': 'FH', 'LastName': 'Bækkerud', 'Affiliation': 'Department of Circulation and Medical Imaging, Faculty of Medicine and Health Sciences, NTNU-Norwegian University of Science and Technology, Post Box 8905, 7491 Trondheim, Norway.'}, {'ForeName': 'Atefe R', 'Initials': 'AR', 'LastName': 'Tari', 'Affiliation': 'Department of Circulation and Medical Imaging, Faculty of Medicine and Health Sciences, NTNU-Norwegian University of Science and Technology, Post Box 8905, 7491 Trondheim, Norway.'}, {'ForeName': 'Silvana B', 'Initials': 'SB', 'LastName': 'Sandbakk', 'Affiliation': 'Department of Circulation and Medical Imaging, Faculty of Medicine and Health Sciences, NTNU-Norwegian University of Science and Technology, Post Box 8905, 7491 Trondheim, Norway.'}, {'ForeName': 'Trude', 'Initials': 'T', 'LastName': 'Carlsen', 'Affiliation': 'Department of Circulation and Medical Imaging, Faculty of Medicine and Health Sciences, NTNU-Norwegian University of Science and Technology, Post Box 8905, 7491 Trondheim, Norway.'}, {'ForeName': 'Jan E', 'Initials': 'JE', 'LastName': 'Ingebrigtsen', 'Affiliation': 'Department of Sociology and Political Science, Faculty of Social Sciences and Technology Management, NTNU-Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Stian', 'Initials': 'S', 'LastName': 'Lydersen', 'Affiliation': 'Regional Centre for Child and Youth Mental Health and Child Welfare, NTNU-Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Erney', 'Initials': 'E', 'LastName': 'Mattsson', 'Affiliation': 'Department of Circulation and Medical Imaging, Faculty of Medicine and Health Sciences, NTNU-Norwegian University of Science and Technology, Post Box 8905, 7491 Trondheim, Norway.'}, {'ForeName': 'Sigmund A', 'Initials': 'SA', 'LastName': 'Anderssen', 'Affiliation': 'Department of Sports Medicine, The Norwegian School of Sport Sciences, Oslo, Norway.'}, {'ForeName': 'Maria A', 'Initials': 'MA', 'LastName': 'Fiatarone Singh', 'Affiliation': 'Exercise Health and Performance Faculty Research Group, Faculty of Health Sciences, The University of Sydney, Lidcombe, Australia.'}, {'ForeName': 'Jeff S', 'Initials': 'JS', 'LastName': 'Coombes', 'Affiliation': 'School of Human Movement and Nutrition Science, University of Queensland, Queensland, Australia.'}, {'ForeName': 'Eirik', 'Initials': 'E', 'LastName': 'Skogvoll', 'Affiliation': 'Department of Circulation and Medical Imaging, Faculty of Medicine and Health Sciences, NTNU-Norwegian University of Science and Technology, Post Box 8905, 7491 Trondheim, Norway.'}, {'ForeName': 'Lars J', 'Initials': 'LJ', 'LastName': 'Vatten', 'Affiliation': 'Department of Public Health and General Practice, Faculty of Medicine, NTNU-Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Jorunn L', 'Initials': 'JL', 'LastName': 'Helbostad', 'Affiliation': 'Department of Neuromedicine and Movement Science, Faculty of Medicine and Health Sciences, NTNU-Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Øivind', 'Initials': 'Ø', 'LastName': 'Rognmo', 'Affiliation': 'Department of Circulation and Medical Imaging, Faculty of Medicine and Health Sciences, NTNU-Norwegian University of Science and Technology, Post Box 8905, 7491 Trondheim, Norway.'}, {'ForeName': 'Ulrik', 'Initials': 'U', 'LastName': 'Wisløff', 'Affiliation': 'Department of Circulation and Medical Imaging, Faculty of Medicine and Health Sciences, NTNU-Norwegian University of Science and Technology, Post Box 8905, 7491 Trondheim, Norway ulrik.wisloff@ntnu.no.'}]",BMJ (Clinical research ed.),['10.1136/bmj.m3485']
3118,33029968,Effects of Multicomponent Exercise on Cognitive Function in Elderly Korean Individuals.,"BACKGROUND AND PURPOSE


The aim of this study was to investigate the effects of multicomponent exercise on cognitive function, depression, and quality of life in elderly individuals.
METHODS


This study prospectively recruited 605 participants, and constructed an exercise pyramid comprising even distributions of daily physical activities, aerobic exercise, muscle-strengthening exercise, flexibility exercise, balance exercise, and activities that subjects could perform while sitting down. The exercise program was divided into six stages according to the participant's level of frailty. The 12-week exercise program intervention was conducted once yearly.
RESULTS


The exercise regimen was followed by 402 of the 605 enrolled participants, giving a dropout rate of 33.6%. The 27-month exercise program was completed by 60 participants. The scores for the Mini Mental State Examination for dementia screening (MMSE-DS), short form of the Geriatric Depression Scale, World Health Organization Quality of Life Assessment (WHOQOL-BREF), International Physical Activity Questionnaire (IPAQ), fear of falling, handgrip strength, and walking speed were improved after the exercise intervention. The analysis of frailty revealed that participants in the frail group showed greater improvements for the MMSE-DS, WHOQOL-BREF, IPAQ, fear of falling, handgrip strength, and walking speed.
CONCLUSIONS


Individually customized, multicomponent exercise programs lead to improved levels of cognitive function, depression, and quality of life, especially among those who are more frail.",2020,"The analysis of frailty revealed that participants in the frail group showed greater improvements for the MMSE-DS, WHOQOL-BREF, IPAQ, fear of falling, handgrip strength, and walking speed.
","['elderly individuals', '605 participants', 'Elderly Korean Individuals']","['exercise program intervention', 'Multicomponent Exercise', 'exercise pyramid comprising even distributions of daily physical activities, aerobic exercise, muscle-strengthening exercise, flexibility exercise, balance exercise, and activities that subjects could perform while sitting down', 'multicomponent exercise']","['Cognitive Function', 'Mini Mental State Examination for dementia screening (MMSE-DS), short form of the Geriatric Depression Scale, World Health Organization Quality of Life Assessment (WHOQOL-BREF), International Physical Activity Questionnaire (IPAQ), fear of falling, handgrip strength, and walking speed', 'MMSE-DS, WHOQOL-BREF, IPAQ, fear of falling, handgrip strength, and walking speed', 'cognitive function, depression, and quality of life', 'levels of cognitive function, depression, and quality of life']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0034229', 'cui_str': 'Pyramidal tract structure'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0452260', 'cui_str': 'Muscular strength development exercise'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0150219', 'cui_str': 'Balance exercises'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0560831', 'cui_str': 'Does sit down'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0451184', 'cui_str': 'Geriatric depression scale'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0281588', 'cui_str': 'Assessment of quality of life'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0877040', 'cui_str': 'Fear of falling'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",605.0,0.022109,"The analysis of frailty revealed that participants in the frail group showed greater improvements for the MMSE-DS, WHOQOL-BREF, IPAQ, fear of falling, handgrip strength, and walking speed.
","[{'ForeName': 'Yeon Jung', 'Initials': 'YJ', 'LastName': 'Kim', 'Affiliation': 'Department of Neurology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Hyuntae', 'Initials': 'H', 'LastName': 'Park', 'Affiliation': 'Department of Health Care and Science, Dong-A University College of Medicine, Busan, Korea.'}, {'ForeName': 'Jong Hwan', 'Initials': 'JH', 'LastName': 'Park', 'Affiliation': 'Institute of Convergence Bio-Health, Dong-A University College of Medicine, Busan, Korea.'}, {'ForeName': 'Kyung Won', 'Initials': 'KW', 'LastName': 'Park', 'Affiliation': 'Department of Health Care and Science, Dong-A University College of Medicine, Busan, Korea.'}, {'ForeName': 'Kiheon', 'Initials': 'K', 'LastName': 'Lee', 'Affiliation': 'Department of Family Medicine, Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea.'}, {'ForeName': 'Sukil', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Department of Public Health, College of Medicine, Catholic University, Seoul, Korea.'}, {'ForeName': 'Kyunghee', 'Initials': 'K', 'LastName': 'Chae', 'Affiliation': 'Department of Public Health, College of Medicine, Catholic University, Seoul, Korea.'}, {'ForeName': 'Moon Ho', 'Initials': 'MH', 'LastName': 'Park', 'Affiliation': 'Department of Neurology, College of Medicine, Korea. University, Seoul, Korea.'}, {'ForeName': 'Seong Ho', 'Initials': 'SH', 'LastName': 'Koh', 'Affiliation': 'Department of Neurology, Hanyang University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Hae Ri', 'Initials': 'HR', 'LastName': 'Na', 'Affiliation': 'Department of Neurology, Seongnam Center of Senior Health, Seongnam, Korea.'}]","Journal of clinical neurology (Seoul, Korea)",['10.3988/jcn.2020.16.4.612']
3119,33016987,Effectiveness of a Home- and School-Based Asthma Educational Program for Head Start Children With Asthma: A Randomized Clinical Trial.,"Importance


Asthma is the most common chronic childhood disease, with Black children experiencing worse morbidity and mortality. It is important to evaluate the effectiveness of efficacious interventions in community settings that have the greatest likelihood of serving at-risk families.
Objective


To evaluate the effectiveness of a multilevel home- and school (Head Start)-based asthma educational program compared with a Head Start-based asthma educational program alone in improving asthma outcomes in children.
Design, Setting, and Participant


This randomized clinical trial included 398 children with asthma enrolled in Head Start preschool programs in Baltimore, Maryland, and their primary caregivers. Participants were recruited from April 1, 2011, to November 31, 2016, with final data collection ending December 31, 2017. Data were analyzed from March 18 to August 30, 2018.
Interventions


Asthma Basic Care (ABC) family education combined with Head Start asthma education compared with Head Start asthma education alone.
Main Outcomes and Measures


Asthma control as measured by the Test for Respiratory and Asthma Control in Kids (TRACK) score.
Results


Among the 398 children included in the analysis (247 boys [62.1%]; mean [SD] age, 4.2 [0.7] years), the ABC plus Head Start program improved asthma control (β = 6.26; 95% CI, 1.77 to 10.75; P < .001), reduced courses of oral corticosteroids (β = -0.61; 95% CI, -1.13 to -0.09; P = .02), and reduced hospitalizations (odds ratio, 0.36; 95% CI, 0.21-0.61; P < .001) during a 12-month period.
Conclusion and Relevance


In this randomized clinical trial, combined family and preschool asthma educational interventions improved asthma control and reduced courses of oral corticosteroids and hospitalizations. Multilevel interventions implemented in community settings that serve low-income minority families may be key to reducing disparities in asthma outcomes.
Trial Registration


ClinicalTrials.gov Identifier: NCT01519453.",2020,"In this randomized clinical trial, combined family and preschool asthma educational interventions improved asthma control and reduced courses of oral corticosteroids and hospitalizations.","['Participants were recruited from April 1, 2011, to November 31, 2016, with final data collection ending December 31, 2017', 'With Asthma', 'Head Start Children', '398 children with asthma enrolled in Head Start preschool programs in Baltimore, Maryland, and their primary caregivers', '398 children included in the analysis (247 boys [62.1%]; mean [SD] age, 4.2 [0.7] years', 'children']","['multilevel home- and school (Head Start)-based asthma educational program compared with a Head Start-based asthma educational program alone', 'combined family and preschool asthma educational interventions', 'Interventions\n\n\nAsthma Basic Care (ABC) family education combined with Head Start asthma education compared with Head Start asthma education alone', 'Home- and School-Based Asthma Educational Program']","['reduced hospitalizations', 'Main Outcomes and Measures\n\n\nAsthma control as measured by the Test for Respiratory and Asthma Control in Kids (TRACK) score', 'reduced courses of oral corticosteroids']","[{'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0004716', 'cui_str': 'Baltimore'}, {'cui': 'C0024858', 'cui_str': 'Maryland'}, {'cui': 'C1319883', 'cui_str': 'Primary caregiver'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517758', 'cui_str': '4.2'}, {'cui': 'C4517474', 'cui_str': '0.7'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0150577', 'cui_str': 'Education of family'}, {'cui': 'C1679754', 'cui_str': 'Asthma education'}]","[{'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]",398.0,0.0679052,"In this randomized clinical trial, combined family and preschool asthma educational interventions improved asthma control and reduced courses of oral corticosteroids and hospitalizations.","[{'ForeName': 'Michelle N', 'Initials': 'MN', 'LastName': 'Eakin', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, The Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Zaeh', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, The Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Eckmann', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, The Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Ruvalcaba', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, The Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Cynthia S', 'Initials': 'CS', 'LastName': 'Rand', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, The Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Marisa E', 'Initials': 'ME', 'LastName': 'Hilliard', 'Affiliation': ""Department of Pediatrics, Baylor College of Medicine and Texas Children's Hospital, Houston.""}, {'ForeName': 'Kristin A', 'Initials': 'KA', 'LastName': 'Riekert', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, The Johns Hopkins University, Baltimore, Maryland.'}]",JAMA pediatrics,['10.1001/jamapediatrics.2020.3375']
3120,33016996,"Tranexamic Acid During Prehospital Transport in Patients at Risk for Hemorrhage After Injury: A Double-blind, Placebo-Controlled, Randomized Clinical Trial.","Importance


In-hospital administration of tranexamic acid after injury improves outcomes in patients at risk for hemorrhage. Data demonstrating the benefit and safety of the pragmatic use of tranexamic acid in the prehospital phase of care are lacking for these patients.
Objective


To assess the effectiveness and safety of tranexamic acid administered before hospitalization compared with placebo in injured patients at risk for hemorrhage.
Design, Setting, and Participants


This pragmatic, phase 3, multicenter, double-blind, placebo-controlled, superiority randomized clinical trial included injured patients with prehospital hypotension (systolic blood pressure ≤90 mm Hg) or tachycardia (heart rate ≥110/min) before arrival at 1 of 4 US level 1 trauma centers, within an estimated 2 hours of injury, from May 1, 2015, through October 31, 2019.
Interventions


Patients received 1 g of tranexamic acid before hospitalization (447 patients) or placebo (456 patients) infused for 10 minutes in 100 mL of saline. The randomization scheme used prehospital and in-hospital phase assignments, and patients administered tranexamic acid were allocated to abbreviated, standard, and repeat bolus dosing regimens on trauma center arrival.
Main Outcomes and Measures


The primary outcome was 30-day all-cause mortality.
Results


In all, 927 patients (mean [SD] age, 42 [18] years; 686 [74.0%] male) were eligible for prehospital enrollment (460 randomized to tranexamic acid intervention; 467 to placebo intervention). After exclusions, the intention-to-treat study cohort comprised 903 patients: 447 in the tranexamic acid arm and 456 in the placebo arm. Mortality at 30 days was 8.1% in patients receiving tranexamic acid compared with 9.9% in patients receiving placebo (difference, -1.8%; 95% CI, -5.6% to 1.9%; P = .17). Results of Cox proportional hazards regression analysis, accounting for site, verified that randomization to tranexamic acid was not associated with a significant reduction in 30-day mortality (hazard ratio, 0.81; 95% CI, 0.59-1.11, P = .18). Prespecified dosing regimens and post-hoc subgroup analyses found that prehospital tranexamic acid were associated with significantly lower 30-day mortality. When comparing tranexamic acid effect stratified by time to treatment and qualifying shock severity in a post hoc comparison, 30-day mortality was lower when tranexamic acid was administered within 1 hour of injury (4.6% vs 7.6%; difference, -3.0%; 95% CI, -5.7% to -0.3%; P < .002). Patients with severe shock (systolic blood pressure ≤70 mm Hg) who received tranexamic acid demonstrated lower 30-day mortality compared with placebo (18.5% vs 35.5%; difference, -17%; 95% CI, -25.8% to -8.1%; P < .003).
Conclusions and Relevance


In injured patients at risk for hemorrhage, tranexamic acid administered before hospitalization did not result in significantly lower 30-day mortality. The prehospital administration of tranexamic acid after injury did not result in a higher incidence of thrombotic complications or adverse events. Tranexamic acid given to injured patients at risk for hemorrhage in the prehospital setting is safe and associated with survival benefit in specific subgroups of patients.
Trial Registration


ClinicalTrials.gov Identifier: NCT02086500.",2020,The prehospital administration of tranexamic acid after injury did not result in a higher incidence of thrombotic complications or adverse events.,"['927 patients (mean [SD] age, 42 [18] years; 686 [74.0%] male) were eligible for prehospital enrollment (460 randomized to', 'injured patients with prehospital hypotension (systolic blood pressure ≤90 mm Hg) or tachycardia (heart rate ≥110/min) before arrival at 1 of 4 US level 1 trauma centers, within an estimated 2 hours of injury, from May 1, 2015, through October 31, 2019', 'arm and 456 in the placebo arm', '903 patients: 447 in the', 'patients at risk for hemorrhage', 'Patients at Risk for Hemorrhage', 'Patients with severe shock (systolic blood pressure ≤70 mm Hg', 'injured patients at risk for hemorrhage']","['tranexamic acid intervention; 467 to placebo', 'Tranexamic Acid', 'tranexamic acid', 'placebo (456 patients) infused for 10 minutes in 100 mL of saline', 'placebo', 'Placebo', 'prehospital tranexamic acid', 'Tranexamic acid']","['30-day mortality', 'Mortality', '30-day all-cause mortality', 'thrombotic complications or adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C5191070', 'cui_str': '686'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0039231', 'cui_str': 'Tachycardia'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0456950', 'cui_str': 'Level 4'}, {'cui': 'C0040786', 'cui_str': 'Trauma center'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C1292425', 'cui_str': '2 hours'}, {'cui': 'C0332273', 'cui_str': 'Through'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0036974', 'cui_str': 'Shock'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4517784', 'cui_str': '467'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4707055', 'cui_str': 'Infuse'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.772109,The prehospital administration of tranexamic acid after injury did not result in a higher incidence of thrombotic complications or adverse events.,"[{'ForeName': 'Francis X', 'Initials': 'FX', 'LastName': 'Guyette', 'Affiliation': 'Department of Emergency Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Joshua B', 'Initials': 'JB', 'LastName': 'Brown', 'Affiliation': 'Division of Trauma and General Surgery, Department of Surgery, Pittsburgh Trauma Research Center, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Mazen S', 'Initials': 'MS', 'LastName': 'Zenati', 'Affiliation': 'Division of Trauma and General Surgery, Department of Surgery, Pittsburgh Trauma Research Center, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Barbara J', 'Initials': 'BJ', 'LastName': 'Early-Young', 'Affiliation': 'Department of Critical Care Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'Adams', 'Affiliation': 'Department of Critical Care Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Eastridge', 'Affiliation': 'Department of Surgery, University of Texas Health San Antonio, San Antonio.'}, {'ForeName': 'Raminder', 'Initials': 'R', 'LastName': 'Nirula', 'Affiliation': 'Department of Surgery, University of Utah, Salt Lake City.'}, {'ForeName': 'Gary A', 'Initials': 'GA', 'LastName': 'Vercruysse', 'Affiliation': 'Department of Surgery, University of Arizona, Tucson.'}, {'ForeName': 'Terence', 'Initials': 'T', 'LastName': ""O'Keeffe"", 'Affiliation': 'Department of Surgery, University of Arizona, Tucson.'}, {'ForeName': 'Bellal', 'Initials': 'B', 'LastName': 'Joseph', 'Affiliation': 'Department of Surgery, University of Arizona, Tucson.'}, {'ForeName': 'Louis H', 'Initials': 'LH', 'LastName': 'Alarcon', 'Affiliation': 'Division of Trauma and General Surgery, Department of Surgery, Pittsburgh Trauma Research Center, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Clifton W', 'Initials': 'CW', 'LastName': 'Callaway', 'Affiliation': 'Department of Emergency Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Brian S', 'Initials': 'BS', 'LastName': 'Zuckerbraun', 'Affiliation': 'Division of Trauma and General Surgery, Department of Surgery, Pittsburgh Trauma Research Center, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Neal', 'Affiliation': 'Division of Trauma and General Surgery, Department of Surgery, Pittsburgh Trauma Research Center, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Raquel M', 'Initials': 'RM', 'LastName': 'Forsythe', 'Affiliation': 'Division of Trauma and General Surgery, Department of Surgery, Pittsburgh Trauma Research Center, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Rosengart', 'Affiliation': 'Division of Trauma and General Surgery, Department of Surgery, Pittsburgh Trauma Research Center, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Timothy R', 'Initials': 'TR', 'LastName': 'Billiar', 'Affiliation': 'Division of Trauma and General Surgery, Department of Surgery, Pittsburgh Trauma Research Center, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Donald M', 'Initials': 'DM', 'LastName': 'Yealy', 'Affiliation': 'Department of Emergency Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Andrew B', 'Initials': 'AB', 'LastName': 'Peitzman', 'Affiliation': 'Division of Trauma and General Surgery, Department of Surgery, Pittsburgh Trauma Research Center, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Jason L', 'Initials': 'JL', 'LastName': 'Sperry', 'Affiliation': 'Division of Trauma and General Surgery, Department of Surgery, Pittsburgh Trauma Research Center, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA surgery,['10.1001/jamasurg.2020.4350']
3121,33017047,"Low dose ketamine reduces pain perception and blood pressure, but not muscle sympathetic nerve activity, responses during a cold pressor test.","KEY POINTS


Low dose ketamine is a leading medication used to provide analgesia in pre-hospital and hospital settings. Low dose ketamine is increasingly used off-label to treat conditions such as depression. In animals, ketamine stimulates the sympathetic nervous system and increases blood pressure, but these physiological consequences have not been studied in conscious humans. Our data suggest that low dose ketamine administration blunts pain perception and reduces blood pressure, but not muscle sympathetic nerve activity burst frequency, responses during a cold pressor test in healthy humans. These mechanistic, physiological results inform risk-benefit analysis for clinicians administering low dose ketamine in humans.
ABSTRACT


Low dose ketamine is an effective analgesic medication. However, our knowledge of the effects of ketamine on autonomic cardiovascular regulation is primarily limited to animal experiments. Notably, it is unknown if low dose ketamine influences autonomic cardiovascular responses during painful stimuli in humans. We tested the hypothesis that low dose ketamine blunts perceived pain, and blunts subsequent sympathetic and cardiovascular responses during an experimental noxious stimulus. Twenty-two adults (10F/12M; 27 ± 6 years; 26 ± 3 kg m -2  , mean ± SD) completed this randomized, crossover, placebo-controlled trial during two laboratory visits. During each visit, participants completed cold pressor tests (CPT; hand in ∼0.4°C ice bath for 2 min) pre- and 5 min post-drug administration (20 mg ketamine or saline). We compared pain perception (100 mm visual analogue scale), muscle sympathetic nerve activity (MSNA; microneurography, 12 paired recordings), and beat-to-beat blood pressure (BP; photoplethysmography) during the pre- and post-drug CPTs separately using paired, two-tailed t tests. For the pre-drug CPT, perceived pain (P = 0.4378), MSNA burst frequency responses (P = 0.7375), and mean BP responses (P = 0.6457) were not different between trials. For the post-drug CPT, ketamine compared to placebo administration attenuated perceived pain (P < 0.0001) and mean BP responses (P = 0.0047), but did not attenuate MSNA burst frequency responses (P = 0.3662). Finally, during the post-drug CPT, there was a moderate relation between cardiac output and BP responses after placebo administration (r = 0.53, P = 0.0121), but this relation was effectively absent after ketamine administration (r = -0.12, P = 0.5885). These data suggest that low dose ketamine administration attenuates perceived pain and pressor, but not MSNA burst frequency, responses during a CPT.",2020,"For the post-drug CPT, ketamine compared to placebo administration attenuated perceived pain (p<0.0001) and mean BP responses (p = 0.0047), but did not attenuate MSNA burst frequency responses (p = 0.3662).","['healthy humans', 'Twenty-two adults (10F/12M', '27±6', 'painful stimuli in humans']","['cold pressor tests (CPT; hand in ∼0.4°C ice bath for two minutes) pre- and five minutes post-drug administration (20 mg ketamine or saline', 'placebo', 'ketamine']","['mean BP responses', 'pain and pressor', 'autonomic cardiovascular regulation', 'pain perception and blood pressure', 'blood pressure', 'pain', 'pain perception (100 mm visual analog scale), muscle sympathetic nerve activity (MSNA; microneurography, 12 paired recordings) and beat-to-beat blood pressure (BP; photoplethysmography', 'cardiac output and BP responses', 'autonomic cardiovascular responses', 'pain perception and reduces blood pressure', 'MSNA burst frequency responses']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}]","[{'cui': 'C0444689', 'cui_str': 'Cold pressor test'}, {'cui': 'C0006938', 'cui_str': 'Captopril'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0556914', 'cui_str': 'Ice bath treatment'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0150270', 'cui_str': 'Management of drug regimen'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0459521', 'cui_str': 'Sympathetic nerve structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0162599', 'cui_str': 'Photoplethysmography'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",22.0,0.134162,"For the post-drug CPT, ketamine compared to placebo administration attenuated perceived pain (p<0.0001) and mean BP responses (p = 0.0047), but did not attenuate MSNA burst frequency responses (p = 0.3662).","[{'ForeName': 'Joseph C', 'Initials': 'JC', 'LastName': 'Watso', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas and University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Mu', 'Initials': 'M', 'LastName': 'Huang', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas and University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Gilbert', 'Initials': 'G', 'LastName': 'Moralez', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas and University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Matthew N', 'Initials': 'MN', 'LastName': 'Cramer', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas and University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Hendrix', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas and University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Frank A', 'Initials': 'FA', 'LastName': 'Cimino', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas and University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Luke N', 'Initials': 'LN', 'LastName': 'Belval', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas and University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Hinojosa-Laborde', 'Affiliation': 'US Army Institute of Surgical Research, JBSA Fort Sam Houston, TX, USA.'}, {'ForeName': 'Craig G', 'Initials': 'CG', 'LastName': 'Crandall', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas and University of Texas Southwestern Medical Center, Dallas, TX, USA.'}]",The Journal of physiology,['10.1113/JP280706']
3122,33011010,Results of a Family-Based Intervention Promoting Healthy Weight Strategies in Overweight Hispanic Adolescents and Parents: An RCT.,"INTRODUCTION


Hispanic adolescents in the U.S. are disproportionately affected by overweight and obesity compared with their White, non-Hispanic counterparts. This study examines the efficacy of an evidence-based family intervention adapted to target obesity-related outcomes among Hispanic adolescents who were overweight/obese compared with prevention as usual.
STUDY DESIGN


This study was an RCT.
SETTING/PARTICIPANTS


Participants were Hispanic adolescents who were overweight/obese (n=280, mean age=13.01 [SD=0.82] years) in the 7th/8th grade and their primary caregivers. Primary caregivers were majority female legal guardians (88% female, mean age=41.88 [SD=6.50] years).
INTERVENTION


Participants were randomized into the family-level obesity-targeted intervention or referral to community services offered for overweight/obese adolescents and families (condition). Data collection began in 2015.
MAIN OUTCOME MEASURES


Primary outcomes included dietary intake (e.g., reduction of sweetened beverages) and past-month moderate-to-vigorous physical activity. Secondary outcomes were BMI and family functioning assessed among adolescents and primary caregivers.
RESULTS


Study analyses (2019) indicated no significant intervention effects for adolescents' primary outcomes. Intervention effects were found for parents' intake of fresh fruits and vegetables (β=0.12, 95% CI=0.02, 0.23), added sugar (β= -0.11, 95% CI= -0.22, -0.004), and sweetened beverages (β= -0.12, 95% CI=-0.23, -0.02), and parents showed decreased BMI (β= -0.05, 95% CI= -0.11, -0.01) at 6 months after baseline compared with usual prevention. Intervention effects were found for adolescent family communication (β=0.13, 95% CI=0.02, 0.24), peer monitoring (β=0.12, 95% CI=0.01, 0.23), and parental involvement (β=0.16, 95% CI=0.06, 0.26) at 6 months after baseline compared with prevention as usual.
CONCLUSIONS


This intervention was not effective in improving overweight/obesity-related outcomes in adolescents. The intervention was effective in improving parents' dietary intake and BMI; however, the effects were not sustained in the long term. Other intervention strategies (e.g., booster sessions, increased nutritional information) may be necessary to sustain beneficial effects and extend effects to adolescent participants.
TRIAL REGISTRATION


This study is registered at www.clinicaltrials.gov NCT03943628.",2020,"Intervention effects were found for parents' intake of fresh fruits and vegetables (β=0.12, 95% CI=0.02, 0.23), added sugar (β= -0.11, 95% CI= -0.22, -0.004), and sweetened beverages (β= -0.12, 95% CI=-0.23, -0.02), and parents showed decreased BMI (β= -0.05, 95% CI= -0.11, -0.01) at 6 months after baseline compared with usual prevention.","['adolescent participants', 'Hispanic adolescents who were overweight/obese compared with prevention as usual', 'Overweight Hispanic Adolescents and Parents', 'Hispanic adolescents', 'Participants were Hispanic adolescents who were overweight/obese']","['Family-Based Intervention Promoting Healthy Weight Strategies', 'family-level obesity-targeted intervention or referral to community services offered for overweight/obese adolescents and families (condition', 'evidence-based family intervention']","['BMI', 'BMI and family functioning assessed among adolescents and primary caregivers', ""parents' dietary intake and BMI"", ""parents' intake of fresh fruits and vegetables"", 'majority female legal guardians', 'dietary intake (e.g., reduction of sweetened beverages) and past-month moderate-to-vigorous physical activity', 'adolescent family communication']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0030551', 'cui_str': 'Parent'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C4040088', 'cui_str': 'Referral to community service'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0680051', 'cui_str': 'Family functioning capacity'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1319883', 'cui_str': 'Primary caregiver'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0453268', 'cui_str': 'Fresh fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0023226', 'cui_str': 'Legal guardian'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0009452', 'cui_str': 'Communication'}]",,0.132731,"Intervention effects were found for parents' intake of fresh fruits and vegetables (β=0.12, 95% CI=0.02, 0.23), added sugar (β= -0.11, 95% CI= -0.22, -0.004), and sweetened beverages (β= -0.12, 95% CI=-0.23, -0.02), and parents showed decreased BMI (β= -0.05, 95% CI= -0.11, -0.01) at 6 months after baseline compared with usual prevention.","[{'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Prado', 'Affiliation': 'School of Nursing and Health Studies, University of Miami, Coral Gables, Florida. Electronic address: gprado@miami.edu.'}, {'ForeName': 'Alejandra', 'Initials': 'A', 'LastName': 'Fernandez', 'Affiliation': 'School of Nursing and Health Studies, University of Miami, Coral Gables, Florida.'}, {'ForeName': 'Sara M', 'Initials': 'SM', 'LastName': 'St George', 'Affiliation': 'Department of Public Health Sciences, University of Miami, Miami, Florida.'}, {'ForeName': 'Tae K', 'Initials': 'TK', 'LastName': 'Lee', 'Affiliation': 'Department of Public Health Sciences, University of Miami, Miami, Florida.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Lebron', 'Affiliation': 'Department of Public Health Sciences, University of Miami, Miami, Florida.'}, {'ForeName': 'Maria I', 'Initials': 'MI', 'LastName': 'Tapia', 'Affiliation': 'School of Nursing and Health Studies, University of Miami, Coral Gables, Florida.'}, {'ForeName': 'Maria Rosa', 'Initials': 'MR', 'LastName': 'Velazquez', 'Affiliation': 'School of Nursing and Health Studies, University of Miami, Coral Gables, Florida.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Messiah', 'Affiliation': ""Department of Public Health Sciences, University of Miami, Miami, Florida; Department of Pediatrics, Miller School of Medicine, University of Miami, Miami, Florida; University of Texas Health Science Center, School of Public Health, Dallas, Texas; Center for Pediatric Population Health, UTHealth School of Public Health and Children's Health System of Texas, Dallas, Texas.""}]",American journal of preventive medicine,['10.1016/j.amepre.2020.06.010']
3123,33011546,"Could ""triple-therapy"" considered as a novel-optimal treatment model for acute bipolar depression? A prospective real-world research in China.","BACKGROUND


Results of researches of bipolar depression treatment are inconsistent and to our knowledge, no study has previously revealed an optimal treatment model for bipolar depression in the real-world through a prospective way.
OBJECTIVE


To find out an optimal treatment model for bipolar depression in the real-world by evaluating the effect of different treatment models: monotherapy, double-therapy and triple-therapy.
DESIGN


and Intervention: This 12 or 16-week, multi-center, real-world clinical study was conducted at 15 study sites (inpatient or outpatient department) in West China and a total of 573 patients completed the follow-up. During the study weeks, all researchers could choose a most proper treatment model freely basing on the evaluation of patient's symptoms and complete the follow-up according to the procedure.
MAIN OUTCOMES AND MEASURES


The primary outcomes were baseline-to-endpoint change in Montgomery-Asberg Depression Rating Scale (MADRS) total score and the constituent ratio of effects. Total score change in Young Mania Rating Scale (YMRS) and Clinical Global Impression (CGI) from baseline to endpoint, treatment-emergent mania rate and severe adverse events rate were used as secondary outcomes.
RESULTS


During all study weeks, all the 3 groups showed a statistically significant improvement in MARDS, YMRS and CGI (P＜0.001), but the triple-therapy group showed much more effective in significant response and response rates at endpoint than double-therapy group and monotherapy group (P＜0.001) with lower treatment-emergent mania rates (P = 0.001). At week 4, mean scores of MARDS in triple-therapy group are statistically significant lower than monotherapy group (P = 0.013) and at the endpoint, mean scores of MARDS in triple-therapy group are statistically significant lower than both double-therapy and monotherapy groups (P = 0.011). The severe adverse events rates are rare in all the 3 groups at week 4 and endpoint, and the rate of dry mouth in triple-therapy group at week 4 is statistically significant lower than the other 2 groups (P = 0.002).
CONCLUSIONS


Triple-therapy is more effective in treating bipolar depression than double-therapy and monotherapy model with a lower risk of developing manic symptoms.
TRIAL REGISTRATION


Chinese Clinical Trial Registry. Identifier: ChiCTR1800019064.",2020,"During all study weeks, all the 3 groups showed a statistically significant improvement in MARDS, YMRS and CGI (P＜0.001), but the triple-therapy group showed much more effective in significant response and response rates at endpoint than double-therapy group and monotherapy group (P＜0.001) with lower treatment-emergent mania rates (P = 0.001).",['15 study sites (inpatient or outpatient department) in West China and a total of 573 patients completed the follow-up'],"['monotherapy, double-therapy and triple-therapy']","['severe adverse events rates', 'MARDS, YMRS and CGI', 'mean scores of MARDS', 'rate of dry mouth', 'baseline-to-endpoint change in Montgomery-Asberg Depression Rating Scale (MADRS) total score and the constituent ratio of effects', 'mania rate and severe adverse events rate', 'response and response rates', 'Total score change in Young Mania Rating Scale (YMRS) and Clinical Global Impression (CGI', 'mania rates']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0037769', 'cui_str': 'West syndrome'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4708164', 'cui_str': '573'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205174', 'cui_str': 'Triple'}]","[{'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}, {'cui': 'C4087288', 'cui_str': 'Young mania rating scale'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0043352', 'cui_str': 'Xerostomia'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0729650', 'cui_str': 'Constituents'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0338831', 'cui_str': 'Mania'}]",573.0,0.0263737,"During all study weeks, all the 3 groups showed a statistically significant improvement in MARDS, YMRS and CGI (P＜0.001), but the triple-therapy group showed much more effective in significant response and response rates at endpoint than double-therapy group and monotherapy group (P＜0.001) with lower treatment-emergent mania rates (P = 0.001).","[{'ForeName': 'Yaling', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Mental Health Center, West China Hospital of Sichuan University, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ""Sichuan Provincial Center for Mental Health, Psychosomatic Medical Center of Sichuan People's Hospital, China.""}, {'ForeName': 'Ruhan', 'Initials': 'R', 'LastName': 'A', 'Affiliation': 'Sleep Medicine Center of University of Electronic Science and Technology Hospital, China.'}, {'ForeName': 'Yuexin', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Mental Health Center, West China Hospital of Sichuan University, China.'}, {'ForeName': 'Xueli', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'Mental Health Center, West China Hospital of Sichuan University, China. Electronic address: sunxueli2018@126.com.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.09.017']
3124,33011649,The Unified Protocol compared with diagnosis-specific protocols for anxiety disorders: 12-month follow-up from a randomized clinical trial.,"OBJECTIVE


To examine whether the Unified Protocol (UP) remains equivalent to single-disorder protocols (SDPs) in the treatment of anxiety disorders at 12-month follow-up.
METHOD


We report results from the 12-month follow-up of a recent randomized equivalence trial [1]. Data are from 179 participants (55.31% female sex, 83.24% White, average age 30.66) who met criteria for a principal anxiety disorder and were randomized to either the UP or SDP conditions. Consistent with the parent trial, the primary outcome was principal diagnosis clinician severity rating (CSR) from the Anxiety Disorder Interview Schedule (ADIS). Secondary outcomes included anxiety, depression, and impairment. Missing data were accommodated using multiple imputation (10,000 imputed data sets) under a missing at random assumption. Equivalence between the UP and SDPs was tested using slope difference scores from latent growth models and 95% confidence interval of between-condition effect sizes.
RESULTS


The results indicated that the UP and SDP conditions remained equivalent with regard to principal diagnosis clinician severity rating at 12-month follow-up. In addition, there were no significant differences between conditions on secondary outcomes at 12-month follow-up.
CONCLUSIONS


The UP continues to yield outcomes comparable to SDPs at 12-month follow-up, and therefore provides a single intervention that can be used to treat the most commonly occurring psychiatric disorders with durable effects.",2020,The results indicated that the UP and SDP conditions remained equivalent with regard to principal diagnosis clinician severity rating at 12-month follow-up.,"['179 participants (55.31% female sex, 83.24% White, average age 30.66) who met criteria for a principal anxiety disorder']",['diagnosis-specific protocols'],"['anxiety, depression, and impairment', 'principal diagnosis clinician severity rating (CSR) from the Anxiety Disorder Interview Schedule (ADIS', 'principal diagnosis clinician severity rating']","[{'cui': 'C4517609', 'cui_str': '179'}, {'cui': 'C0086287', 'cui_str': 'Female'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}]","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0332137', 'cui_str': 'Principal diagnosis'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}]",,0.0824821,The results indicated that the UP and SDP conditions remained equivalent with regard to principal diagnosis clinician severity rating at 12-month follow-up.,"[{'ForeName': 'Elizabeth H', 'Initials': 'EH', 'LastName': 'Eustis', 'Affiliation': 'Center for Anxiety and Related Disorders, Department of Psychological and Brain Sciences, Boston University, 900 Commonwealth Ave. 2(nd) Floor, Boston, MA 02215, United States of America. Electronic address: eeustis@bu.edu.'}, {'ForeName': 'Matthew W', 'Initials': 'MW', 'LastName': 'Gallagher', 'Affiliation': 'Department of Psychology, The University of Houston, Health and Biomedical Sciences Building, 4849 Calhoun Rd - Room 373, Houston, TX 77204, United States of America.'}, {'ForeName': 'Julianne W', 'Initials': 'JW', 'LastName': 'Tirpak', 'Affiliation': 'Center for Anxiety and Related Disorders, Department of Psychological and Brain Sciences, Boston University, 900 Commonwealth Ave. 2(nd) Floor, Boston, MA 02215, United States of America.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Nauphal', 'Affiliation': 'Center for Anxiety and Related Disorders, Department of Psychological and Brain Sciences, Boston University, 900 Commonwealth Ave. 2(nd) Floor, Boston, MA 02215, United States of America.'}, {'ForeName': 'Todd J', 'Initials': 'TJ', 'LastName': 'Farchione', 'Affiliation': 'Center for Anxiety and Related Disorders, Department of Psychological and Brain Sciences, Boston University, 900 Commonwealth Ave. 2(nd) Floor, Boston, MA 02215, United States of America.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Barlow', 'Affiliation': 'Center for Anxiety and Related Disorders, Department of Psychological and Brain Sciences, Boston University, 900 Commonwealth Ave. 2(nd) Floor, Boston, MA 02215, United States of America.'}]",General hospital psychiatry,['10.1016/j.genhosppsych.2020.08.012']
3125,33011734,The Potential Role of Lung-Protective Ventilation in Preventing Postoperative Delirium in Elderly Patients Undergoing Prone Spinal Surgery: A Preliminary Study.,"BACKGROUND Postoperative delirium (POD) is a frequent complication in elderly patients, usually occurring within a few days after surgery. This study investigated the effect of lung-protective ventilation (LPV) on POD in elderly patients undergoing spinal surgery and the mechanism by which LPV suppresses POD. MATERIAL AND METHODS Seventy-one patients aged ≥65 years were randomized to receive LPV or conventional mechanical ventilation (MV), consisting of intermittent positive pressure ventilation following induction of anesthesia. The tidal volume in patients who received MV was 8 ml/kg predicted body weight (PBW), and the ventilation frequency was 12 times/min. The tidal volume in patients who received LPV was 6 ml/kg PBW, the positive end-expiratory pressure was 5 cmH₂O, and the ventilation frequency was 15 times/min, with a lung recruitment maneuver performed every 30 min. Blood samples were collected immediately before anesthesia induction (T₀), 10 min (T₁) and 60 min (T₂) after turning over, immediately after the operation (T₃), and 15 min after extubation (T₄) for blood gas analysis. Simultaneous cerebral oxygen saturation (rSO₂) and cerebral desaturation were recorded. Preoperative and postoperative serum concentrations of interleukin (IL)-6, IL-10 and glial fibrillary acidic protein (GFAP) were measured by ELISA. POD was assessed by nursing delirium screening score. RESULTS Compared with the MV group, pH was lower and PaCO₂ higher in the LPV group at T₂. In addition PaO₂, SaO₂, and PaO₂/FiO₂ were higher at T₁, and T₄, and rSO₂ was higher at T₃, and T₄ in the LPV than in the MV group (P<0.05 each). Postoperative serum GFAP and IL-6 were lower and IL-10 higher in the LPV group. The incidences of cerebral desaturation and POD were significantly lower in the LPV group (P<0.05). CONCLUSIONS LPV may reduce POD in elderly patients undergoing spinal surgery by inhibiting inflammation and improving cerebral oxygen metabolism.",2020,The incidences of cerebral desaturation and POD were significantly lower in the LPV group (P<0.05).,"['elderly patients', 'Undergoing Prone Spinal Surgery', 'Elderly Patients', 'elderly patients undergoing spinal surgery', 'elderly patients undergoing spinal surgery and the mechanism by which LPV suppresses POD', 'Seventy-one patients aged ≥65 years']","['LPV or conventional mechanical ventilation (MV), consisting of intermittent positive pressure ventilation following induction of anesthesia', 'lung-protective ventilation (LPV', 'LPV', 'Lung-Protective Ventilation']","['cerebral desaturation and POD', 'Preoperative and postoperative serum concentrations of interleukin (IL)-6, IL-10 and glial fibrillary acidic protein (GFAP', 'cerebral oxygen metabolism', 'ventilation frequency', 'Postoperative serum GFAP and IL-6', 'tidal volume', 'POD', 'Simultaneous cerebral oxygen saturation (rSO₂) and cerebral desaturation', 'addition PaO₂, SaO₂, and PaO₂/FiO₂\xa0were higher at T₁, and T₄, and rSO₂']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033422', 'cui_str': 'Prone body position'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0441712', 'cui_str': 'Mechanisms'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C1260953', 'cui_str': 'Suppressed'}, {'cui': 'C4721772', 'cui_str': 'Postoperative delirium'}, {'cui': 'C0450389', 'cui_str': '71'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0021778', 'cui_str': 'Intermittent positive pressure ventilation'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0853212', 'cui_str': 'Induction of anaesthesia'}]","[{'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}, {'cui': 'C4721772', 'cui_str': 'Postoperative delirium'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0017626', 'cui_str': 'Glial fibrillary acidic protein'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C4273907', 'cui_str': 'Cerebral oxygen saturation'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205250', 'cui_str': 'High'}]",71.0,0.076425,The incidences of cerebral desaturation and POD were significantly lower in the LPV group (P<0.05).,"[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, The Third Hospital of Hebei Medical University, Shijiazhuang, Hebei, China (mainland).'}, {'ForeName': 'Lian', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': 'Department of Emergency Center of Trauma, The Third Hospital of Hebei Medical University, Shijiazhuang, Hebei, China (mainland).'}, {'ForeName': 'Yanan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, The Third Hospital of Hebei Medical University, Shijiazhuang, Hebei, China (mainland).'}, {'ForeName': 'Chunping', 'Initials': 'C', 'LastName': 'Yin', 'Affiliation': 'Department of Anesthesiology, The Third Hospital of Hebei Medical University, Shijiazhuang, Hebei, China (mainland).'}, {'ForeName': 'Zhiyong', 'Initials': 'Z', 'LastName': 'Hou', 'Affiliation': 'Department of Emergency Center of Trauma, The Third Hospital of Hebei Medical University, Shijiazhuang, Hebei, China (mainland).'}, {'ForeName': 'Qiujun', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, The Third Hospital of Hebei Medical University, Shijiazhuang, Hebei, China (mainland).'}]",Medical science monitor : international medical journal of experimental and clinical research,['10.12659/MSM.926526']
3126,33011968,Comparative study between single versus dual trigger for poor responders in GnRH-antagonist ICSI cycles: A randomized controlled study.,"OBJECTIVE


To investigate whether dual triggering of final oocyte maturation with a combination of gonadotropin-releasing hormone (GnRH) agonist and human chorionic gonadotropin (hCG) can improve the number of retrieved oocytes and clinical pregnancy rate in poor responders undergoing in vitro fertilization/intracytoplasmic sperm injection (IVF-ICSI) cycles using a GnRH-antagonist protocol.
METHODS


A randomized controlled trial included poor ovarian responders indicated for ICSI using a GnRH-antagonist protocol. They were divided equally into two groups: group I received 10 000 units of hCG plus 0.2 mg of triptorelin while group II received 10 000 units of hCG only for triggering of ovulation. The primary outcome parameter was the number of oocytes retrieved. Secondary outcomes included metaphase II oocytes number, cancellation rate, number of obtained embryos, chemical and clinical pregnancy rates.
RESULTS


One hundred and sixty women were included in the study, with 80 women in each treatment group. Dual triggering was associated with higher number of retrieved oocytes (5.3 ± 1.9 vs 4.5 ± 2.4, P=0.014), metaphase II oocytes (3.8 ± 1.4 vs 3.1 ± 1.7, P=0.004), total and grade 1 embryos (2.7 ± 1.1 and 2.3 ± 1.0 vs 1.9 ± 1.2 and 1.1 ± 0.2, P=0.001 and 0.021 respectively), and transferred embryos (2.2 ± 0.9 vs 1.6 ± 0.9, P=0.043, and lower cancellation rate (7.5% vs 20%, P=0.037) compared with single triggering. There were significantly higher chemical (25% vs 11.3%, P=0.039) and clinical (22.5% vs 8.8%, P=0.028) pregnancy rates in women with dual triggering compared with those with single triggering.
CONCLUSION


Dual triggering is associated with better IVF outcome in poor responders compared with single trigger. Clinical trial registration NCT04008966.",2020,"There were significantly higher chemical (25% vs 11.3%, P=0.039) and clinical (22.5% vs 8.8%, P=0.028) pregnancy rates in women with dual triggering compared with those with single triggering.
","['One hundred and sixty women were included in the study, with 80 women in each treatment group', 'poor responders in GnRH-antagonist ICSI cycles', 'poor responders undergoing in vitro fertilization/intracytoplasmic sperm injection (IVF-ICSI) cycles using a GnRH-antagonist protocol']","['hCG plus 0.2\xa0mg of triptorelin while group II received 10\xa0000 units of hCG', 'GnRH-antagonist protocol', 'gonadotropin-releasing hormone (GnRH) agonist and human chorionic gonadotropin (hCG']","['higher number of retrieved oocytes', 'metaphase II oocytes', 'pregnancy rates', 'cancellation rate', 'number of oocytes retrieved', 'IVF outcome', 'metaphase II oocytes number, cancellation rate, number of obtained embryos, chemical and clinical pregnancy rates']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C1268855', 'cui_str': 'Gonadotropin releasing hormone receptor antagonist-containing product'}, {'cui': 'C0455164', 'cui_str': 'IVF - In vitro fertilization with intracytoplasmic sperm injection (ICSI)'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0428402', 'cui_str': 'Human chorionic gonadotropin measurement'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0077275', 'cui_str': 'Triptorelin'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C1268855', 'cui_str': 'Gonadotropin releasing hormone receptor antagonist-containing product'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C0243192', 'cui_str': 'agonists'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0029045', 'cui_str': 'Oocyte'}, {'cui': 'C1621812', 'cui_str': 'Metaphase'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0449803', 'cui_str': 'Number of oocytes'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0013935', 'cui_str': 'Embryos'}, {'cui': 'C0220806', 'cui_str': 'Chemical'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]",160.0,0.293984,"There were significantly higher chemical (25% vs 11.3%, P=0.039) and clinical (22.5% vs 8.8%, P=0.028) pregnancy rates in women with dual triggering compared with those with single triggering.
","[{'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Maged', 'Affiliation': 'Obstetrics and Gynecology Department, Kasr Alainy Hospital Cairo University, Cairo, Egypt.'}, {'ForeName': 'Mohamed A', 'Initials': 'MA', 'LastName': 'Ragab', 'Affiliation': 'Obstetrics and Gynecology Department, Kasr Alainy Hospital Cairo University, Cairo, Egypt.'}, {'ForeName': 'Amal', 'Initials': 'A', 'LastName': 'Shohayeb', 'Affiliation': 'Obstetrics and Gynecology Department, Kasr Alainy Hospital Cairo University, Cairo, Egypt.'}, {'ForeName': 'Waleed', 'Initials': 'W', 'LastName': 'Saber', 'Affiliation': 'Obstetrics and Gynecology Department, Kasr Alainy Hospital Cairo University, Cairo, Egypt.'}, {'ForeName': 'Sherif', 'Initials': 'S', 'LastName': 'Ekladious', 'Affiliation': 'Clinical Pathology Department, Kasr Alainy Hospital Cairo University, Cairo, Egypt.'}, {'ForeName': 'Eman A', 'Initials': 'EA', 'LastName': 'Hussein', 'Affiliation': 'Obstetrics and Gynecology Department, Kasr Alainy Hospital Cairo University, Cairo, Egypt.'}, {'ForeName': 'Akmal', 'Initials': 'A', 'LastName': 'El-Mazny', 'Affiliation': 'Obstetrics and Gynecology Department, Kasr Alainy Hospital Cairo University, Cairo, Egypt.'}, {'ForeName': 'Ayman', 'Initials': 'A', 'LastName': 'Hany', 'Affiliation': 'Obstetrics and Gynecology Department, Kasr Alainy Hospital Cairo University, Cairo, Egypt.'}]",International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics,['10.1002/ijgo.13405']
3127,33017685,Retrograde bladder filling after laparoscopic gynecologic surgery: a double-blind randomized controlled trial.,"OBJECTIVE


To evaluate whether retrofilling the bladder upon completion of elective laparoscopic gynecologic surgery for benign indications has an effect on the timing of the first post-operative void and timing of discharge from hospital.
DESIGN


Double-blind randomized controlled trial SETTING: Single academic surgical day hospital PATIENTS: Patients undergoing outpatient laparoscopic gynecologic surgery, excluding hysterectomy or pelvic reconstructive surgery.
INTERVENTIONS


Upon completion of surgery, patients were randomized to either retrograde filling of the bladder with 200 mL of saline prior to catheter removal or standard care (immediate catheter removal). Patients and PACU nurses (outcome assessors) were both blinded.
MEASUREMENTS


The primary outcome was the time to first void. Secondary outcomes were time to hospital discharge, post-operative urinary tract infection and patient satisfaction.
MAIN RESULTS


Over a 3 month period, 47 patients were approached on the day of surgery, 42 consented and were randomized (21 to intervention and 21 to control). There were no significant differences in baseline demographics between groups. The median time to first void was significantly shorter for patients in the intervention arm compared to controls (104 ± 75min vs 162 ± 76min, p<0.001). Retrofilled patients were discharged faster from PACU compared to controls (155.0 ± 74min vs 227 ± 58min, p=0.001). There were no urinary tract infections in either group and the proportion of satisfied or very satisfied patients was high (93.8% vs. 88.2%, p=0.512).
CONCLUSION


Retrograde filling the bladder after outpatient laparoscopic gynecologic surgery is a safe, effective method that significantly reduces length of hospital stay.",2020,"The median time to first void was significantly shorter for patients in the intervention arm compared to controls (104 ± 75min vs 162 ± 76min, p<0.001).","['Patients undergoing outpatient laparoscopic gynecologic surgery, excluding hysterectomy or pelvic reconstructive surgery', '47 patients were approached on the day of surgery, 42 consented']","['elective laparoscopic gynecologic surgery', 'retrograde filling of the bladder with 200 mL of saline prior to catheter removal or standard care (immediate catheter removal', 'Retrograde bladder filling after laparoscopic gynecologic surgery']","['time to first void', 'median time to first void', 'urinary tract infections', 'length of hospital stay', 'time to hospital discharge, post-operative urinary tract infection and patient satisfaction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0038902', 'cui_str': 'Operation on female genital organs'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0020699', 'cui_str': 'Hysterectomy'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0524865', 'cui_str': 'Reconstruction - action'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C2711213', 'cui_str': 'Consented'}]","[{'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0038902', 'cui_str': 'Operation on female genital organs'}, {'cui': 'C0439784', 'cui_str': 'Retrograde direction'}, {'cui': 'C0005682', 'cui_str': 'Urinary bladder structure'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0394884', 'cui_str': 'Removal of catheter'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}]",47.0,0.474424,"The median time to first void was significantly shorter for patients in the intervention arm compared to controls (104 ± 75min vs 162 ± 76min, p<0.001).","[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Zakhari', 'Affiliation': 'Mount Sinai Hospital, Department of Obstetrics and Gynecology, 600 University Avenue, Toronto ON, Canada, M5G 1\u202f×\u202f5; University of Toronto, Department of Obstetrics & Gynecology, 123 Edwards Street, Toronto, Ontario, Canada, M5G 1E2; McGill University Health Center (MUHC) - Glen Site, 1001 boulevard Décarie, Montreal QC, Canada, H4A 3JI.'}, {'ForeName': 'Wusun', 'Initials': 'W', 'LastName': 'Paek', 'Affiliation': 'Mount Sinai Hospital, Department of Obstetrics and Gynecology, 600 University Avenue, Toronto ON, Canada, M5G 1\u202f×\u202f5; University of Toronto, Department of Obstetrics & Gynecology, 123 Edwards Street, Toronto, Ontario, Canada, M5G 1E2.'}, {'ForeName': 'Wilson', 'Initials': 'W', 'LastName': 'Chan', 'Affiliation': 'Mount Sinai Hospital, Department of Obstetrics and Gynecology, 600 University Avenue, Toronto ON, Canada, M5G 1\u202f×\u202f5; University of Toronto, Department of Obstetrics & Gynecology, 123 Edwards Street, Toronto, Ontario, Canada, M5G 1E2.'}, {'ForeName': 'Darl', 'Initials': 'D', 'LastName': 'Edwards', 'Affiliation': 'Mount Sinai Hospital, Department of Obstetrics and Gynecology, 600 University Avenue, Toronto ON, Canada, M5G 1\u202f×\u202f5; University of Toronto, Department of Obstetrics & Gynecology, 123 Edwards Street, Toronto, Ontario, Canada, M5G 1E2.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Matelski', 'Affiliation': 'Biostatistics Research Unit, University Health Network (UHN), 200 Elizabeth Street, Toronto ON, Canada, M5G 2C4.'}, {'ForeName': 'M Jonathon', 'Initials': 'MJ', 'LastName': 'Solnik', 'Affiliation': 'Mount Sinai Hospital, Department of Obstetrics and Gynecology, 600 University Avenue, Toronto ON, Canada, M5G 1\u202f×\u202f5; University of Toronto, Department of Obstetrics & Gynecology, 123 Edwards Street, Toronto, Ontario, Canada, M5G 1E2.'}, {'ForeName': 'Ally', 'Initials': 'A', 'LastName': 'Murji', 'Affiliation': 'Mount Sinai Hospital, Department of Obstetrics and Gynecology, 600 University Avenue, Toronto ON, Canada, M5G 1\u202f×\u202f5; University of Toronto, Department of Obstetrics & Gynecology, 123 Edwards Street, Toronto, Ontario, Canada, M5G 1E2. Electronic address: ally.murji@sinaihealthsystem.ca.'}]",Journal of minimally invasive gynecology,['10.1016/j.jmig.2020.09.019']
3128,33017755,Admission Blood Pressure and Outcome of Endovascular Therapy: Secondary Analysis of ASTER Trial.,"BACKGROUND


Elevated blood pressure (BP) is common among patients presenting with acute ischemic stroke due to large vessel occlusions. The literature is inconsistent regarding the association between admission BP and outcome of mechanical thrombectomy (MT). Moreover, it is unclear whether the first line thrombectomy strategy (stent retriever [SR] versus contact aspiration [CA]) modifies the relationship between BP and outcome.
METHODS


This is a post hoc analysis of the ASTER (Contact Aspiration Versus Stent Retriever for Successful Revascularization) randomized trial. BP was measured prior to randomization in all included patients. Co-primary outcomes included 90-day functional independence (modified Rankin Scale [mRS] 0-2) and successful revascularization (modified Treatment in Cerebral Ischemia [mTICI] 2b-3). Secondary outcomes included symptomatic intracerebral hemorrhage (sICH) and parenchymal hemorrhage (PH) within 24 hours.
RESULTS


A total of 381 patients were included in the present study. Mean (SD) systolic BP (SBP) and diastolic BP (DBP) were 148 (26) mm Hg and 81 (16) mm Hg, respectively. There was no association between SBP or DBP and successful revascularization or 90-day functional independence. Similarly, there was no association between admission SBP or DBP with sICH or PH. Subgroup analysis based on the first-line thrombectomy strategy revealed similar results with no heterogeneity across groups.
CONCLUSION


Admission BP was not associated with functional, angiographic or safety outcomes. Results were similar in both CA and CA groups.",2020,There was no association between SBP or DBP and successful revascularization or 90-day functional independence.,"['patients presenting with acute ischemic stroke due to large vessel occlusions', 'A total of 381 patients were included in the present study']",['contact aspiration [CA'],"['Mean (SD) systolic BP (SBP) and diastolic BP (DBP', 'symptomatic intracerebral hemorrhage (sICH) and parenchymal hemorrhage (PH', 'SBP or DBP and successful revascularization or 90-day functional independence', '90-day functional independence (modified Rankin Scale [mRS] 0-2) and successful revascularization (modified Treatment in Cerebral Ischemia', 'Admission BP', 'BP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0225990', 'cui_str': 'Large blood vessel structure'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4708787', 'cui_str': '381'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0004056', 'cui_str': 'Aspiration, Psychology'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0007785', 'cui_str': 'Cerebral infarction'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]",381.0,0.0769627,There was no association between SBP or DBP and successful revascularization or 90-day functional independence.,"[{'ForeName': 'Mohnammd', 'Initials': 'M', 'LastName': 'Anadani', 'Affiliation': 'Department of Neurology, Washington University School of Medicine, St Louis, MO, United States. Electronic address: manadani@wustl.edu.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Lapergue', 'Affiliation': 'Department of Stroke Center, Foch Hospital, Suresnes, France. Electronic address: bertrand.lapergue@gmail.com.'}, {'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Blanc', 'Affiliation': 'Department of Interventional Neuroradiology, Rothschild Foundation, Paris, France. Electronic address: rblanc29@gmail.com.'}, {'ForeName': 'Maéva', 'Initials': 'M', 'LastName': 'Kyheng', 'Affiliation': 'Department of Biostatistics, University Lille, CHU Lille, EA 2694-Santé Publique: Epidémiologie et Qualité des Soins, France. Electronic address: maeva.kyheng@chru-lille.fr.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Labreuche', 'Affiliation': 'Department of Biostatistics, University Lille, CHU Lille, EA 2694-Santé Publique: Epidémiologie et Qualité des Soins, France. Electronic address: julien.labreuche.chru@gmail.com.'}, {'ForeName': 'Malek Ben', 'Initials': 'MB', 'LastName': 'Machaa', 'Affiliation': 'Department of Interventional Neuroradiology, Rothschild Foundation, Paris, France. Electronic address: mbenmaacha@for.paris.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Duhamel', 'Affiliation': 'Department of Biostatistics, University Lille, CHU Lille, EA 2694-Santé Publique: Epidémiologie et Qualité des Soins, France. Electronic address: alain.duhamel59@gmail.com.'}, {'ForeName': 'Gautier', 'Initials': 'G', 'LastName': 'Marnat', 'Affiliation': 'Department of Neuroradiology, University Hospital of Bordeaux, France. Electronic address: gaultier.marnat@chu-bordeaux.fr.'}, {'ForeName': 'Suzana', 'Initials': 'S', 'LastName': 'Saleme', 'Affiliation': 'Department of Interventional Neuroradiology, University Hospital of Limoges, France. Electronic address: suzanna.saleme@chu-limoges.fr.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Costalat', 'Affiliation': 'Department of Neuroradiology, Hôpital Gui de Chauliac, Montpellier, France. Electronic address: vincentcost@hotmail.com.'}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Bracard', 'Affiliation': 'Department of Diagnostic and Therapeutic Neuroradiology, University Hospital of Nancy, Université de Lorraine, INSERM U1254, Nancy, France. Electronic address: s.bracard@chru-nancy.fr.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Anxionnat', 'Affiliation': 'Department of Diagnostic and Therapeutic Neuroradiology, University Hospital of Nancy, Université de Lorraine, INSERM U1254, Nancy, France. Electronic address: r.anxionnat@gmail.com.'}, {'ForeName': 'Alejandro M', 'Initials': 'AM', 'LastName': 'Spiotta', 'Affiliation': 'Department of Neurosurgery, Medical University of South Carolina, Charleston, SC, United States. Electronic address: spiotta@musc.edu.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'DeHavenon', 'Affiliation': 'Department of Neurology, Utah University, Salt lake, UT, United States. Electronic address: adam.dehavenon@hsc.utah.edu.'}, {'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Richard', 'Affiliation': 'Department of Neurology, Stroke Unit, University Hospital of Nancy, Université de Lorraine, INSERM U1116, Nancy, France. Electronic address: s.richard@chru-nancy.fr.'}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Desal', 'Affiliation': 'Department of Neuroradiology, Guillaume et René Laennec University Hospital, Nantes, France. Electronic address: hubert.desal@chu-nantes.fr.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Mazighi', 'Affiliation': 'Department of Interventional Neuroradiology, Rothschild Foundation, Paris, France. Electronic address: mmazighi@for.paris.'}, {'ForeName': 'Arturo', 'Initials': 'A', 'LastName': 'Consoli', 'Affiliation': 'Department of Neuroradiology, Foch Hospital, Suresnes, France. Electronic address: a.consoli@hopital-foch.com.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Piotin', 'Affiliation': 'Department of Interventional Neuroradiology, Rothschild Foundation, Paris, France. Electronic address: mpiotin@for.paris.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Gory', 'Affiliation': 'Department of Diagnostic and Therapeutic Neuroradiology, University Hospital of Nancy, Université de Lorraine, INSERM U1254, Nancy, France. Electronic address: benjagory@gmail.com.'}]",Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association,['10.1016/j.jstrokecerebrovasdis.2020.105347']
3129,33017784,Nitrous oxide analgesia for external cephalic version: A randomized controlled trial.,"STUDY OBJECTIVE


Our study sought to determine whether or not nitrous oxide analgesia decreases pain compared to oxygen placebo during external cephalic version for breech presentation. Procedural success may be limited by pain and anxiety. Although neuraxial anesthesia has been studied extensively for these procedures, many centers lack resources for routine use. Nitrous oxide is noninvasive, has minimal side effects and requires limited facilities. We hypothesized that its analgesic properties would decrease pain compared to oxygen placebo during external cephalic version.
DESIGN


Double-blinded randomized placebo-controlled trial.
SETTING


Labor and delivery triage room.
PATIENTS


Forty-eight patients, ≥18 years of age, 37-weeks' gestation or beyond, singleton pregnancy, breech presentation, and American Society of Anesthesiology physical status I-III, having an external cephalic version.
INTERVENTIONS


Patients undergoing external cephalic version were randomized to receive self-administered 50% nitrous oxide/50% oxygen versus 100% oxygen placebo.
MEASUREMENTS


The primary outcome measured was intra-procedural pain. Secondary outcomes were intra-procedural anxiety, patient satisfaction, and procedure difficulty.
MAIN RESULTS


Forty-eight patients were enrolled; 23 received nitrous oxide and 25 received oxygen. No difference was noted in mean pain scores (nitrous oxide 5.5 ± 2.3, placebo 5.4 ± 2.7, [CI 95%  = -1.40, 1.51]; P = 0.943) or anxiety scores (nitrous oxide 1.6 ± 2.0, placebo 1.2 ± 1.8, [CI 95%  = -0.74, 1.45]; P = 0.515). Procedural difficulty (1-10 scale, 1 = very easy, 10 = extremely difficult) was not different between groups (nitrous oxide 6.1 ± 2.2, placebo 6.1 ± 3.2, [CI 95%  = -1.54, 1.66]; P = 0.944). There was a significant increase in the number of version attempts in the nitrous oxide group (nitrous oxide 3.9 ± 1.9, placebo 2.8 ± 1.4, [CI 95%  = 0.05, 2]; P = 0.046). Patient satisfaction was significantly lower in the nitrous oxide group (nitrous oxide 4.3 ± 4.0, placebo 6.9 ± 3.6, [CI 95%  = -4.93, -0.34]; P = 0.025).
CONCLUSION


Despite the desirable properties of nitrous oxide, there was no analgesic benefit over oxygen for external cephalic version. Its routine use for these procedures was not supported.",2020,"Procedural difficulty (1-10 scale, 1 = very easy, 10 = extremely difficult) was not different between groups (nitrous oxide 6.1 ± 2.2, placebo 6.1 ± 3.2, [CI 95%  = -1.54, 1.66];","['external cephalic version', 'Forty-eight patients were enrolled; 23 received', 'Patients undergoing external cephalic version', ""Forty-eight patients, ≥18\xa0years of age, 37-weeks' gestation or beyond, singleton pregnancy, breech presentation, and American Society of Anesthesiology physical status I-III, having an external cephalic version"", 'Labor and delivery triage room']","['placebo', 'Nitrous oxide', 'nitrous oxide and 25 received oxygen', 'oxygen placebo', 'Nitrous oxide analgesia', 'self-administered 50% nitrous oxide/50% oxygen versus 100% oxygen placebo', 'nitrous oxide analgesia', 'nitrous oxide']","['mean pain scores', 'Patient satisfaction', 'anxiety scores', 'Procedural difficulty', 'intra-procedural anxiety, patient satisfaction, and procedure difficulty', 'number of version attempts', 'intra-procedural pain', 'pain']","[{'cui': 'C0410877', 'cui_str': 'External cephalic version'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0006157', 'cui_str': 'Breech presentation'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0040861', 'cui_str': 'Triage'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0028215', 'cui_str': 'Nitrous Oxide'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C3854439', 'cui_str': 'Procedural anxiety'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C1619712', 'cui_str': 'Procedural pain'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",48.0,0.62946,"Procedural difficulty (1-10 scale, 1 = very easy, 10 = extremely difficult) was not different between groups (nitrous oxide 6.1 ± 2.2, placebo 6.1 ± 3.2, [CI 95%  = -1.54, 1.66];","[{'ForeName': 'Lacey E', 'Initials': 'LE', 'LastName': 'Straube', 'Affiliation': 'University of North Carolina School of Medicine, Department of Anesthesiology, N2198 UNC Hospitals CB#7010, Chapel Hill, NC 27599-7010, USA. Electronic address: Lacey_straube@med.unc.edu.'}, {'ForeName': 'Kristen L', 'Initials': 'KL', 'LastName': 'Fardelmann', 'Affiliation': 'University of North Carolina School of Medicine, Department of Anesthesiology, N2198 UNC Hospitals CB#7010, Chapel Hill, NC 27599-7010, USA. Electronic address: Kristen.fardelmann@yale.edu.'}, {'ForeName': 'Amy A', 'Initials': 'AA', 'LastName': 'Penwarden', 'Affiliation': 'University of North Carolina School of Medicine, Department of Anesthesiology, N2198 UNC Hospitals CB#7010, Chapel Hill, NC 27599-7010, USA. Electronic address: APenwarden@napaanesthesia.com.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Chen', 'Affiliation': 'University of North Carolina School of Medicine, Department of Anesthesiology, N2198 UNC Hospitals CB#7010, Chapel Hill, NC 27599-7010, USA. Electronic address: fei_chen@med.unc.edu.'}, {'ForeName': 'Elsje', 'Initials': 'E', 'LastName': 'Harker', 'Affiliation': 'University of North Carolina School of Medicine, Department of Anesthesiology, N2198 UNC Hospitals CB#7010, Chapel Hill, NC 27599-7010, USA. Electronic address: elsje.harker@duke.unc.edu.'}, {'ForeName': 'Benjamin F', 'Initials': 'BF', 'LastName': 'Redmon', 'Affiliation': 'University of North Carolina School of Medicine, Department of Anesthesiology, N2198 UNC Hospitals CB#7010, Chapel Hill, NC 27599-7010, USA. Electronic address: Benjamin.redmon@duke.edu.'}, {'ForeName': 'Quefeng', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'University of North Carolina School of Public Health, Department of Biostatistics, 135 Dauer Drive, Chapel Hill, NC 27599, USA. Electronic address: quefeng@email.unc.edu.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Strauss', 'Affiliation': 'University of North Carolina School of Medicine, Department of Obstetrics & Gynecology, 3009 Old Clinic Building, CB 7050, Chapel Hill, NC 27599, USA. Electronic address: Robert_strauss@med.unc.edu.'}, {'ForeName': 'Kathleen A', 'Initials': 'KA', 'LastName': 'Smith', 'Affiliation': 'University of North Carolina School of Medicine, Department of Anesthesiology, N2198 UNC Hospitals CB#7010, Chapel Hill, NC 27599-7010, USA. Electronic address: Kathleen_a_smith@med.unc.edu.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.110073']
3130,33019392,Gestational diabetes mellitus in women increased the risk of neonatal infection via inflammation and autophagy in the placenta.,"BACKGROUND


Gestational diabetes mellitus (GDM) produces numerous problems for maternal and fetal outcomes. However, the precise molecular mechanisms of GDM are not clear.
METHODS


In our study, we randomly assigned 22 pregnant women with fasting glucose concentrations, 1 hour oral glucose tolerance test (1H-OGTT) and 2 hour oral glucose tolerance test (2H-OGTT), different than 28 normal pregnant women from a sample of 107 pregnant women at the First Affiliated Hospital of Jinan University in China. Lipopolysaccharide (LPS), interleukin 1 alpha (IL-1α), interleukin-6 (IL-6), interleukin-8 (IL-8) and tumor necrosis factor alpha (TNF-α) were measured from blood plasma of pregnant women and umbilical arteries using ultraviolet spectrophotometry. Hematoxylin & Eosin (H&E), Periodic acid-Schiff (PAS) or Masson staining were performed to examine whether diabetes mellitus altered the morphology of placenta. Quantitative PCR (Q-PCR), western blotting and immunofluorescent staining were performed to examine whether diabetes mellitus and autophagy altered the gene expressions of the placental tissue.
RESULTS


We found that women with GDM exhibited increased placental weight and risk of neonatal infection. The concentrations of IL-6 protein and IL-8 protein in GDM were increased in both maternal and umbilical arterial blood. H&E, Masson and PAS staining results showed an increased number of placental villi and glycogen deposition in patients with GDM, but no placental sclerosis was found. Q-PCR results suggested that the expression levels of HIF-1α and the toll like receptor 4 (TLR4)/ myeloid differential protein-88 (MyD88)/ nuclear factor kappa-B (NF-κB) pathway were increased in the GDM placenta. Through Western Blotting, we found that the expression of NF-kappa-B inhibitor alpha (IKBα) and Nuclear factor-κB p65 (NF-κB p65) in GDM placenta was significantly enhanced. We also showed that the key autophagy-related genes, autophagy-related 7 (ATG7) and microtubule-associated protein 1A/1B-light chain 3 (LC3), were increased in GDM compared with normal pregnant women.
CONCLUSIONS


Our results suggest that women with GDM exhibit an increased risk of neonatal infection via inflammation and autophagy in the placenta.",2020,The concentrations of IL-6 protein and IL-8 protein in GDM were increased in both maternal and umbilical arterial blood.,"['women with GDM', 'Gestational diabetes mellitus (GDM', '22 pregnant women with fasting glucose concentrations, 1 hour oral glucose tolerance test (1H-OGTT) and 2 hour oral glucose tolerance test (2H-OGTT), different than 28 normal pregnant women from a sample of 107 pregnant women at the First Affiliated Hospital of Jinan University in China']","['Periodic acid-Schiff (PAS) or Masson staining', 'Hematoxylin & Eosin']","['concentrations of IL-6 protein and IL-8 protein in GDM', 'risk of neonatal infection via inflammation and autophagy', 'Quantitative PCR (Q-PCR), western blotting and immunofluorescent staining', 'expression of NF-kappa-B inhibitor alpha (IKBα) and Nuclear factor-κB p65 (NF-κB p65) in GDM placenta', 'Gestational diabetes mellitus', 'expression levels of HIF-1α and the toll like receptor 4 (TLR4)/ myeloid differential protein-88 (MyD88)/ nuclear factor kappa-B (NF-κB) pathway', 'number of placental villi and glycogen deposition', 'Lipopolysaccharide (LPS), interleukin 1 alpha (IL-1α), interleukin-6 (IL-6), interleukin-8 (IL-8) and tumor necrosis factor alpha (TNF-α', 'placental weight and risk of neonatal infection', 'placental sclerosis']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0427743', 'cui_str': 'Glucose concentration, test strip measurement'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C1292425', 'cui_str': '2 hours'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0440048', 'cui_str': 'Periodic acid Schiff stain'}, {'cui': 'C0487602', 'cui_str': 'Staining method'}, {'cui': 'C0018964', 'cui_str': 'Hematoxylin stain'}, {'cui': 'C0014448', 'cui_str': 'Eosine Yellowish'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0854706', 'cui_str': 'Neonatal infection'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0004391', 'cui_str': 'Autophagocytosis'}, {'cui': 'C1709846', 'cui_str': 'Real-Time PCR'}, {'cui': 'C0005863', 'cui_str': 'Western Blotting'}, {'cui': 'C0183489', 'cui_str': 'Immunofluorescent stain'}, {'cui': 'C0487602', 'cui_str': 'Staining method'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C2002434', 'cui_str': 'NFKBIA protein, human'}, {'cui': 'C0299809', 'cui_str': 'PAK2 Kinase'}, {'cui': 'C0032043', 'cui_str': 'Placental structure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1321919', 'cui_str': 'TLR4 protein, human'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0439677', 'cui_str': 'Myeloid'}, {'cui': 'C0443199', 'cui_str': 'Differential'}, {'cui': 'C0079904', 'cui_str': 'Immunoglobulin Enhancer-Binding Protein'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0008508', 'cui_str': 'Chorionic villi structure'}, {'cui': 'C0333566', 'cui_str': 'Glycogen deposition'}, {'cui': 'C0023810', 'cui_str': 'Lipopolysaccharide'}, {'cui': 'C0600251', 'cui_str': 'interleukin-1, alpha'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0036429', 'cui_str': 'Sclerosis'}]",22.0,0.04294,The concentrations of IL-6 protein and IL-8 protein in GDM were increased in both maternal and umbilical arterial blood.,"[{'ForeName': 'Yi-Xiao', 'Initials': 'YX', 'LastName': 'Li', 'Affiliation': 'The First Affiliate Hospital of Jinan University.'}, {'ForeName': 'Deng-Lu', 'Initials': 'DL', 'LastName': 'Long', 'Affiliation': 'International Joint Laboratory for Embryonic Development & Prenatal Medicine, Division of Histology and Embryology, Medical College.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'The First Affiliate Hospital of Jinan University.'}, {'ForeName': 'Di', 'Initials': 'D', 'LastName': 'Qiu', 'Affiliation': 'The First Affiliate Hospital of Jinan University.'}, {'ForeName': 'Jingyun', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'The First Affiliate Hospital of Jinan University.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Cheng', 'Affiliation': 'International Joint Laboratory for Embryonic Development & Prenatal Medicine, Division of Histology and Embryology, Medical College.'}, {'ForeName': 'Xuesong', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'International Joint Laboratory for Embryonic Development & Prenatal Medicine, Division of Histology and Embryology, Medical College.'}, {'ForeName': 'Rui-Man', 'Initials': 'RM', 'LastName': 'Li', 'Affiliation': 'The First Affiliate Hospital of Jinan University.'}, {'ForeName': 'Guang', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'International Joint Laboratory for Embryonic Development & Prenatal Medicine, Division of Histology and Embryology, Medical College.'}]",Medicine,['10.1097/MD.0000000000022152']
3131,33034052,"Radiotherapy vs sequential pegaspargase, gemcitabine, cisplatin and dexamethasone and radiotherapy in newly diagnosed early natural killer/T-cell lymphoma: A randomized, controlled, open-label, multicenter study.","To compare the efficacy and safety of radiotherapy (RT) and chemotherapy of pegaspargase, gemcitabine, cisplatin and dexamethasone (DDGP) combined with RT in newly diagnosed stage I-II natural killer/T-cell lymphoma (NKTL), we designed a randomized, controlled, open-label, multicenter clinical trial. Data from 65 stage I-II NKTL patients whose diagnoses were confirmed using immunohistochemistry were enrolled from January 2011 to December 2013 in the First Affiliated Hospital of Zhengzhou University. Patients were randomly divided into the RT group (n = 35) and the DDGP combined with RT group (n = 30). There was a difference between the Eastern Cooperative Oncology Group (ECOG) score in the two arms (P = .013). The complete response rate (CRR) and objective response rate (ORR) of DDGP combined with RT group were superior to those in the RT group (CRR: 73.3% vs 48.6%; ORR: 83.3% vs 60.0%, respectively). The 5-year progression-free survival (PFS) rate and overall survival (OS) rate in the DDGP combined with RT group were higher than those in the RT group (82.9% vs 56.5% for PFS, P = .023; 85.7% vs 60.4% for OS, P = .040), and treatment methods and lactate dehydrogenase were independent risk factors. Myelosuppression (P < .001), gastrointestinal reactions (P < .001), abnormal liver function (P = .007), coagulation abnormalities (P < .001) and baldness (P < .001) were more likely to occur in the DDGP combined with RT group. In conclusion, DDGP combined with radiotherapy obviously obtained great efficacy and prolonged the survival time of patients, also the side effects were mild for stage I-II NKTL. This trial was registered at https://register.clinicaltrials.gov as #NCT01501136.",2020,"Myelosuppression (P < 0.001), gastrointestinal reactions (P < 0.001), abnormal liver function (P = 0.007), coagulation abnormalities (P < 0.001) and baldness (P ","['newly diagnosed early NK/T cell lymphoma', 'newly diagnosed stage I-II natural killer/T-cell lymphoma (NKTL', '65 I-II NKTL patients whose diagnoses were confirmed using immunohistochemistry were enrolled from January 2011 to December 2013 in the First Affiliated Hospital of Zhengzhou University']","['Radiotherapy vs sequential DDGP and radiotherapy', 'DDGP combined with RT', 'DDGP combined with radiotherapy', 'radiotherapy (RT) and chemotherapy of pegaspargase, gemcitabine, cisplatin and dexamethasone (DDGP) combined with RT']","['coagulation abnormalities', 'gastrointestinal reactions', 'complete response rate (CRR) and objective response rate (ORR) of DDGP', 'efficacy and safety', 'abnormal liver function', '5-year progression-free survival (PFS) rate and overall survival (OS) rate', 'survival time', 'Myelosuppression']","[{'cui': 'C0596473', 'cui_str': 'Early Diagnosis'}, {'cui': 'C0558916', 'cui_str': 'NK/T-cell lymphoma, nasal and nasal-type'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0079772', 'cui_str': 'T-cell lymphoma (clinical)'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0021044', 'cui_str': 'Immunohistochemistry'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0071568', 'cui_str': 'pegaspargase'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]","[{'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0086565', 'cui_str': 'Abnormal liver function'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C0854467', 'cui_str': 'Myelosuppression'}]",,0.105272,"Myelosuppression (P < 0.001), gastrointestinal reactions (P < 0.001), abnormal liver function (P = 0.007), coagulation abnormalities (P < 0.001) and baldness (P ","[{'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital of Zhengzhou University: Lymphoma Diagnosed and Treatment Center of Henan Province, Zhengzhou, Henan, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital of Zhengzhou University: Lymphoma Diagnosed and Treatment Center of Henan Province, Zhengzhou, Henan, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital of Zhengzhou University: Lymphoma Diagnosed and Treatment Center of Henan Province, Zhengzhou, Henan, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital of Zhengzhou University: Lymphoma Diagnosed and Treatment Center of Henan Province, Zhengzhou, Henan, China.'}, {'ForeName': 'Xinhua', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital of Zhengzhou University: Lymphoma Diagnosed and Treatment Center of Henan Province, Zhengzhou, Henan, China.'}, {'ForeName': 'Zhenchang', 'Initials': 'Z', 'LastName': 'Sun', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital of Zhengzhou University: Lymphoma Diagnosed and Treatment Center of Henan Province, Zhengzhou, Henan, China.'}, {'ForeName': 'Jingjing', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital of Zhengzhou University: Lymphoma Diagnosed and Treatment Center of Henan Province, Zhengzhou, Henan, China.'}, {'ForeName': 'Xiaorui', 'Initials': 'X', 'LastName': 'Fu', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital of Zhengzhou University: Lymphoma Diagnosed and Treatment Center of Henan Province, Zhengzhou, Henan, China.'}, {'ForeName': 'Xudong', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital of Zhengzhou University: Lymphoma Diagnosed and Treatment Center of Henan Province, Zhengzhou, Henan, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Yu', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital of Zhengzhou University: Lymphoma Diagnosed and Treatment Center of Henan Province, Zhengzhou, Henan, China.'}, {'ForeName': 'Guannan', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'Department of Pathology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Chang', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital of Zhengzhou University: Lymphoma Diagnosed and Treatment Center of Henan Province, Zhengzhou, Henan, China.'}, {'ForeName': 'Jiaqin', 'Initials': 'J', 'LastName': 'Yan', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital of Zhengzhou University: Lymphoma Diagnosed and Treatment Center of Henan Province, Zhengzhou, Henan, China.'}, {'ForeName': 'Zhiyuan', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital of Zhengzhou University: Lymphoma Diagnosed and Treatment Center of Henan Province, Zhengzhou, Henan, China.'}, {'ForeName': 'Xiaolong', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital of Zhengzhou University: Lymphoma Diagnosed and Treatment Center of Henan Province, Zhengzhou, Henan, China.'}, {'ForeName': 'Feifei', 'Initials': 'F', 'LastName': 'Nan', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital of Zhengzhou University: Lymphoma Diagnosed and Treatment Center of Henan Province, Zhengzhou, Henan, China.'}, {'ForeName': 'Wencai', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Pathology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China.'}, {'ForeName': 'Mingzhi', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital of Zhengzhou University: Lymphoma Diagnosed and Treatment Center of Henan Province, Zhengzhou, Henan, China.'}]",International journal of cancer,['10.1002/ijc.33329']
3132,33034157,Exploring correlates of improved depression symptoms and quality of life following tai chi exercise for patients with heart failure.,"AIMS


Tai chi exercise has been shown in a prior randomized controlled trial to improve depression symptoms and quality of life (QoL) in patients with heart failure (HF), but correlates of these improvements are not well known. The purpose of this secondary analysis was to explore whether tai chi is associated with improvements in biopsychosocial and behavioural measures and whether such improvements are correlated with improved depression and QoL.
METHODS AND RESULTS


Participants were n = 100 adults with chronic systolic HF (mean age = 67.4, SD = 12.0; 64% male; 96% White; New York Heart Association class = 1-3) randomized to a 12 week tai chi exercise intervention or health education control. Constructs of interest included social support, exercise self-efficacy, activity engagement, sense of coherence, and inflammatory biomarkers. Tai chi was associated with increased everyday activity engagement compared with the health education group (P < 0.05), but there were no group differences in social support or sense of coherence. Among tai chi participants, improved self-efficacy was correlated with QoL (r = 31, P = 0.05), and there was a trend toward improved depression symptoms and social support (r = -0.22, P = 0.13). Among all participants, controlling for intervention group, improved sense of coherence, and inflammation (C-reactive protein) were associated with improved depression symptoms, and improved self-efficacy, sense of coherence, and frequency of activity engagement were associated with improved QoL.
CONCLUSIONS


Tai chi exercise promotes inter-related psychosocial improvements for patients with HF. A range of biopsychosocial and behavioural variables are relevant to mood management in patients with HF.",2020,"Tai chi was associated with increased everyday activity engagement compared with the health education group (P < 0.05), but there were no group differences in social support or sense of coherence.","['patients with heart failure (HF', 'patients with heart failure', 'Participants were n\xa0=\xa0100 adults with chronic systolic HF (mean age\xa0=\xa067.4, SD\xa0=\xa012.0; 64% male; 96% White; New York Heart Association class\xa0=\xa01-3', 'patients with HF']","['12\xa0week tai chi exercise intervention or health education control', 'Tai chi exercise', 'tai chi exercise']","['sense of coherence, and inflammation (C-reactive protein', 'social support or sense of coherence', 'depression symptoms and quality of life', 'depression symptoms, and improved self-efficacy, sense of coherence, and frequency of activity engagement', 'everyday activity engagement', 'depression symptoms and social support', 'depression symptoms and quality of life (QoL', 'self-efficacy', 'social support, exercise self-efficacy, activity engagement, sense of coherence, and inflammatory biomarkers']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1135194', 'cui_str': 'Chronic systolic heart failure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0456387', 'cui_str': 'Class'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0376403', 'cui_str': 'Tai-chi'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C3178983', 'cui_str': 'Salutogenesis'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",100.0,0.0460636,"Tai chi was associated with increased everyday activity engagement compared with the health education group (P < 0.05), but there were no group differences in social support or sense of coherence.","[{'ForeName': 'Christina M', 'Initials': 'CM', 'LastName': 'Luberto', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital/Harvard Medical School, 100 Cambridge St, 16th Floor, Boston, MA, 02114, USA.'}, {'ForeName': 'Charles A', 'Initials': 'CA', 'LastName': 'Coey', 'Affiliation': ""Department of Preventive Medicine, Brigham and Women's Hospital/Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Roger B', 'Initials': 'RB', 'LastName': 'Davis', 'Affiliation': 'Department of Medicine, Division of General Medicine, Beth Israel Deaconess Medical Center/Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Wayne', 'Affiliation': ""Department of Preventive Medicine, Brigham and Women's Hospital/Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Sydney', 'Initials': 'S', 'LastName': 'Crute', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital/Harvard Medical School, 100 Cambridge St, 16th Floor, Boston, MA, 02114, USA.'}, {'ForeName': 'Gloria Y', 'Initials': 'GY', 'LastName': 'Yeh', 'Affiliation': 'Department of Medicine, Division of General Medicine, Beth Israel Deaconess Medical Center/Harvard Medical School, Boston, MA, USA.'}]",ESC heart failure,['10.1002/ehf2.13046']
3133,33031265,Erector spinae plane block for postoperative pain and recovery in hepatectomy: A randomized controlled trial.,"BACKGROUND


The randomized controlled study aimed to examine the efficacy of preoperative ultrasound-guided erector spinae plane (ESP) block combined with ropivacaine in patients undergoing hepatectomy.
METHODS


A total of 60 patients were randomized to ESP block group receiving ropivacaine (Group A) and control group (Group B), n = 30 per group. Visual analog scale (VAS) was recorded in both the groups during rest and movement at the various time intervals. Both the groups were also compared for time to initial anal exhaust, analgesic usage, early postoperative complications and side-effects, walk distance after the operation, time to out-of-bed activity, and duration of hospital stay.
RESULTS


No significant differences were observed in the demographic characteristics. For group A, when compared to group B, VAS scores during rest and movement within post-operative 24 hours were decreased, the time of first anus exhaust and ambulation were earlier, analgesic consumption and the incidence of postoperative nausea, vomiting and headache was reduced, the duration of hospital stay were shorter with longer walk distance.
CONCLUSION


ESP block combined with ropivacaine treatment effectively reduced early postoperative pain and improved recovery after hepatectomy.",2020,"Both the groups were also compared for time to initial anal exhaust, analgesic usage, early postoperative complications and side-effects, walk distance after the operation, time to out-of-bed activity, and duration of hospital stay.
","['60 patients', 'hepatectomy', 'patients undergoing hepatectomy']","['Erector spinae plane block', 'preoperative ultrasound-guided erector spinae plane (ESP) block combined with ropivacaine', 'ropivacaine', 'ESP block group receiving ropivacaine']","['early postoperative pain', 'time to initial anal exhaust, analgesic usage, early postoperative complications and side-effects, walk distance after the operation, time to out-of-bed activity, and duration of hospital stay', 'VAS scores', 'duration of hospital stay', 'time of first anus exhaust and ambulation were earlier, analgesic consumption and the incidence of postoperative nausea, vomiting and headache', 'Visual analog scale (VAS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019144', 'cui_str': 'Liver excision'}]","[{'cui': 'C0224301', 'cui_str': 'Structure of erector spinae muscle'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0003461', 'cui_str': 'Anal structure'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0520904', 'cui_str': 'Postoperative nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",60.0,0.0733324,"Both the groups were also compared for time to initial anal exhaust, analgesic usage, early postoperative complications and side-effects, walk distance after the operation, time to out-of-bed activity, and duration of hospital stay.
","[{'ForeName': 'Junbao', 'Initials': 'J', 'LastName': 'Fu', 'Affiliation': 'Department of Anesthesiology, Linyi Central Hospital, Linyi, Shandong, China.'}, {'ForeName': 'Guangmeng', 'Initials': 'G', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Yanming', 'Initials': 'Y', 'LastName': 'Qiu', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000022251']
3134,33031270,"Contrast-enhanced ultrasound for determining muscular perfusion after oral intake of L-citrulline, L-arginine, and galloylated epicatechines: A study protocol.","INTRODUCTION


The market for dietary supplements in the sports sector has been growing rapidly for several years, though there is still lacking evidence regarding their claimed benefits. One group is that of nitric oxide increasing supplements, so-called ""NO-boosters,"" which are claimed to improve the supply of oxygen and nutrients to the muscle by enhancing vasodilation.The aim of this study was to investigate 3 of these supplements in healthy male athletes for their muscle perfusion-enhancing potential using contrast-enhanced ultrasound (CEUS).
METHODS


This placebo-controlled, double-blind, randomized cross-over trial will be carried out at the Center for Orthopedics, Trauma Surgery and Spinal Cord Injury of the University Hospital Heidelberg. Three commercial NO enhancing products including 300 mg of the specific green tea extract VASO6 and a combination of 8 g L-citrulline malate and 3 g L-arginine hydrochloride will be examined for their potential to increase muscular perfusion in 30-male athletes between 18 and 40 years and will be compared with a placebo. On each of the 3 appointments CEUS of the dominant biceps muscle will be performed at rest and after a standardized resistance training. Every athlete receives each of the 3 supplements once after a wash-out period of at least 1 week. Perfusion will be quantified via VueBox quantification software. The results of CEUS perfusion measurements will be compared intra- and interindividually and correlated with clinical parameters.
DISCUSSION


The results of this study may help to establish CEUS as a suitable imaging modality for the evaluation of potentially vasodilatory drugs in the field of sports. Other supplements could also be evaluated in this way to verify the content of their advertising claims.
TRIAL REGISTRATION


German Clinical Trials Register (DRKS), ID: DRKS00016972, registered on 25.03.2019.",2020,"The market for dietary supplements in the sports sector has been growing rapidly for several years, though there is still lacking evidence regarding their claimed benefits.","['30-male athletes between 18 and 40 years', 'Center for Orthopedics, Trauma Surgery and Spinal Cord Injury of the University Hospital Heidelberg', 'healthy male athletes']","['muscle perfusion-enhancing potential using contrast-enhanced ultrasound (CEUS', 'nitric oxide', 'Contrast-enhanced ultrasound', 'placebo']",['muscular perfusion'],"[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}]",,0.227635,"The market for dietary supplements in the sports sector has been growing rapidly for several years, though there is still lacking evidence regarding their claimed benefits.","[{'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Doll', 'Affiliation': 'Center for Orthopedics, Trauma Surgery and Spinal Cord Injury, Ultrasound Center, HTRG - Heidelberg Trauma Research Group, Heidelberg University Hospital.'}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Bürkle', 'Affiliation': 'Center for Orthopedics, Trauma Surgery and Spinal Cord Injury, Ultrasound Center, HTRG - Heidelberg Trauma Research Group, Heidelberg University Hospital.'}, {'ForeName': 'Arndt', 'Initials': 'A', 'LastName': 'Neide', 'Affiliation': 'Center for Orthopedics, Trauma Surgery and Spinal Cord Injury, Ultrasound Center, HTRG - Heidelberg Trauma Research Group, Heidelberg University Hospital.'}, {'ForeName': 'Stefanos', 'Initials': 'S', 'LastName': 'Tsitlakidis', 'Affiliation': 'Center for Orthopedics, Trauma Surgery and Spinal Cord Injury, Ultrasound Center, HTRG - Heidelberg Trauma Research Group, Heidelberg University Hospital.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bruckner', 'Affiliation': 'Institute of Medical Biometry and Informatics, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Schmidmaier', 'Affiliation': 'Center for Orthopedics, Trauma Surgery and Spinal Cord Injury, Ultrasound Center, HTRG - Heidelberg Trauma Research Group, Heidelberg University Hospital.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Fischer', 'Affiliation': 'Center for Orthopedics, Trauma Surgery and Spinal Cord Injury, Ultrasound Center, HTRG - Heidelberg Trauma Research Group, Heidelberg University Hospital.'}]",Medicine,['10.1097/MD.0000000000022318']
3135,33031287,Clinical application of accelerated rehabilitation surgery in elderly patients with colorectal cancer.,"BACKGROUND


Gastrointestinal malignant tumors are the most common malignant tumors in elderly people in China, resulting in an increasing trend of morbidity and mortality. We conducted a non-randomized controlled trial to compare the effect of enhanced recovery after surgery (ERAS) versus Routine care on clinical outcomes in elderly patients after colorectal cancer surgery.
METHODS


This is a single center, non-random, parallel-controlled clinical trial, 60 patients aged ≥65 years will be randomized for Case group ERAS and Control group (routine care).
RESULTS


This study will help to evaluate the clinical feasibility, safety and effectiveness of ERAS in elderly patients undergoing colorectal resection compared with routine care.
PROTOCOL REGISTRATION NUMBER


ChiCTR2000034984.",2020,"We conducted a non-randomized controlled trial to compare the effect of enhanced recovery after surgery (ERAS) versus Routine care on clinical outcomes in elderly patients after colorectal cancer surgery.
","['elderly patients with colorectal cancer', 'elderly patients after colorectal cancer surgery', 'elderly patients undergoing colorectal resection compared with routine care', '60 patients aged ≥65 years']","['ERAS', 'Routine care', 'enhanced recovery after surgery (ERAS', 'accelerated rehabilitation surgery']",[],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0192866', 'cui_str': 'Sigmoid colectomy'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]",[],60.0,0.156973,"We conducted a non-randomized controlled trial to compare the effect of enhanced recovery after surgery (ERAS) versus Routine care on clinical outcomes in elderly patients after colorectal cancer surgery.
","[{'ForeName': 'Linxia', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': 'Department of General Surgery (Gastrointestinal Surgery), Hospital of Southwest Medical University, Jiangyang District, Luzhou City, Sichuan Province, China.'}, {'ForeName': 'Xianrong', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Meixuan', 'Initials': 'M', 'LastName': 'Song', 'Affiliation': ''}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': ''}, {'ForeName': 'Xunlian', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000022503']
3136,33031293,The effectiveness of high intensity laser therapy in the patients with lumbar disc herniation: A protocol of randomized placebo-controlled trial.,"BACKGROUND


There is no consensus in existing literature on the pulse power, application time, frequency and the dose of energy of laser therapy for the patients. Therefore, we conducted this research for the assessment of safety and efficiency of ultrasound and high-intensity laser therapy (HILT) in the lumbar disc herniation (LDH) patients.
METHODS


Our present research was approved by the institutional review board in the West China-Guangan Hospital. All the participants would acquire the written informed consent. From December 2020 to December 2021, we will conduct a prospective evaluation via a senior surgeon for 1 hundred LDH patients who plan to undergo the conservative treatment at our hospital. In this research, the inclusion criteria contained: the patients with lumbar disc herniation diagnosed by lumbar MRI; the patients with no history of trauma or congenital abnormalities; and the patients with sufficient psychological ability to understand and then answer the questions raised in assessment scale. The participants were randomly divided into the control group or HILT group after performing the examination of baseline. The main outcome was the pain score of visual analog scale. The other results contained the adverse effects, back range of motion as well as functional scores.
CONCLUSIONS


We assumed that the HILT is as effective as the ultrasound therapy in treating pain for LDH.
TRIAL REGISTRATION


This study protocol was registered in Research Registry (researchregistry5975).",2020,"The other results contained the adverse effects, back range of motion as well as functional scores.
","['1 hundred LDH patients who plan to undergo the conservative treatment at our hospital', 'lumbar disc herniation (LDH) patients', 'patients with lumbar disc herniation', 'patients with lumbar disc herniation diagnosed by lumbar MRI; the patients with no history of trauma or congenital abnormalities']","['high intensity laser therapy', 'ultrasound and high-intensity laser therapy (HILT', 'HILT', 'placebo', 'control group or HILT']","['adverse effects, back range of motion as well as functional scores', 'pain score of visual analog scale']","[{'cui': 'C0281899', 'cui_str': 'Prolapsed lumbar intervertebral disc'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0459914', 'cui_str': 'Conservative therapy'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0332122', 'cui_str': 'No history of'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",,0.0616658,"The other results contained the adverse effects, back range of motion as well as functional scores.
","[{'ForeName': 'Youyi', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'School of Medicine, Nanchang University, Jiangxi.'}, {'ForeName': 'Daxin', 'Initials': 'D', 'LastName': 'Gao', 'Affiliation': 'Department of Orthopedics, West China-Guangan Hospital, Sichuan, China.'}]",Medicine,['10.1097/MD.0000000000022520']
3137,33031603,Efficacy of topical vs combined oral and topical antifungals in white piedra of the scalp.,"BACKGROUND


Topical antifungals are the most commonly used therapy in white piedra of the scalp. However, persistence and relapse of infection still pose a significant challenge. Systemic antifungals have been recommended to enhance the therapeutic response.
AIMS


To compare the efficacy of topical antifungal alone versus combined topical and oral antifungals in the treatment of white piedra of the scalp.
METHODS


Sixty patients with white piedra of the scalp were divided into 3 groups, each containing 20 patients. Group A received topical clotrimazole, group B received combined topical clotrimazole and oral itraconazole, and group C received combined topical clotrimazole and oral terbinafine. The treatment was continued until clearance of infection was confirmed by dermoscopic and mycological examination. Positive responders were followed up for 3 months after treatment.
RESULTS


All the patients achieved complete clearance of infection. The median treatment time in group B was significantly shorter than group A (P < .001) and group C (P < .001), respectively. In addition, the median treatment time in group C was significantly shorter than group A (P = .002). No recurrence of infection was noted during follow-up period.
CONCLUSION


The three modalities were effective in the treatment of white piedra of the scalp. The most rapid response was observed with the combined use of topical and oral azoles.",2020,The median treatment time in group B was significantly shorter than group A (P<0.001) and group C (P<0.001) respectively.,"['white piedra of the scalp', 'Sixty patients with white piedra of the scalp were divided into 3 groups, each containing 20 patients']","['combined topical clotrimazole and oral itraconazole, and group C received combined topical clotrimazole and oral terbinafine', 'topical clotrimazole', 'topical antifungal alone versus combined topical and oral antifungals', 'topical versus combined oral and topical antifungals']","['median treatment time', 'complete clearance of infection', 'recurrence of infection']","[{'cui': 'C0040249', 'cui_str': 'White piedra'}, {'cui': 'C0036270', 'cui_str': 'Scalp structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0332256', 'cui_str': 'Containing'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C3208397', 'cui_str': 'Clotrimazole-containing product in cutaneous dose form'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0064113', 'cui_str': 'Itraconazole'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0076110', 'cui_str': 'terbinafine'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0003308', 'cui_str': 'Antifungal-containing product'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]",60.0,0.0342658,The median treatment time in group B was significantly shorter than group A (P<0.001) and group C (P<0.001) respectively.,"[{'ForeName': 'Yasmina', 'Initials': 'Y', 'LastName': 'El Attar', 'Affiliation': 'Dermatology, Venereology and Andrology Department, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Maii', 'Initials': 'M', 'LastName': 'Atef Shams Eldeen', 'Affiliation': 'Microbiology and Immunology Department, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Reham M', 'Initials': 'RM', 'LastName': 'Wahid', 'Affiliation': 'Physiology Department, Faculty of Medicine, Zagazig University, Zagazig, Egypt.'}, {'ForeName': 'Rania', 'Initials': 'R', 'LastName': 'Alakad', 'Affiliation': 'Dermatology, Venereology and Andrology Department, Faculty of Medicine, Zagazig University, Zagazig, Egypt.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13769']
3138,33031764,"Lopinavir-ritonavir in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial.","BACKGROUND


Lopinavir-ritonavir has been proposed as a treatment for COVID-19 on the basis of in vitro activity, preclinical studies, and observational studies. Here, we report the results of a randomised trial to assess whether lopinavir-ritonavir improves outcomes in patients admitted to hospital with COVID-19.
METHODS


In this randomised, controlled, open-label, platform trial, a range of possible treatments was compared with usual care in patients admitted to hospital with COVID-19. The trial is underway at 176 hospitals in the UK. Eligible and consenting patients were randomly allocated to either usual standard of care alone or usual standard of care plus lopinavir-ritonavir (400 mg and 100 mg, respectively) by mouth for 10 days or until discharge (or one of the other RECOVERY treatment groups: hydroxychloroquine, dexamethasone, or azithromycin) using web-based simple (unstratified) randomisation with allocation concealment. Randomisation to usual care was twice that of any of the active treatment groups (eg, 2:1 in favour of usual care if the patient was eligible for only one active group, 2:1:1 if the patient was eligible for two active groups). The primary outcome was 28-day all-cause mortality. Analyses were done on an intention-to-treat basis in all randomly assigned participants. The trial is registered with ISRCTN, 50189673, and ClinicalTrials.gov, NCT04381936.
FINDINGS


Between March 19, 2020, and June 29, 2020, 1616 patients were randomly allocated to receive lopinavir-ritonavir and 3424 patients to receive usual care. Overall, 374 (23%) patients allocated to lopinavir-ritonavir and 767 (22%) patients allocated to usual care died within 28 days (rate ratio 1·03, 95% CI 0·91-1·17; p=0·60). Results were consistent across all prespecified subgroups of patients. We observed no significant difference in time until discharge alive from hospital (median 11 days [IQR 5 to >28] in both groups) or the proportion of patients discharged from hospital alive within 28 days (rate ratio 0·98, 95% CI 0·91-1·05; p=0·53). Among patients not on invasive mechanical ventilation at baseline, there was no significant difference in the proportion who met the composite endpoint of invasive mechanical ventilation or death (risk ratio 1·09, 95% CI 0·99-1·20; p=0·092).
INTERPRETATION


In patients admitted to hospital with COVID-19, lopinavir-ritonavir was not associated with reductions in 28-day mortality, duration of hospital stay, or risk of progressing to invasive mechanical ventilation or death. These findings do not support the use of lopinavir-ritonavir for treatment of patients admitted to hospital with COVID-19.
FUNDING


Medical Research Council and National Institute for Health Research.",2020,"Among patients not on invasive mechanical ventilation at baseline, there was no significant difference in the proportion who met the composite endpoint of invasive mechanical ventilation or death (risk ratio 1·09, 95% CI 0·99-1·20; p=0·092).
","['and 3424 patients to receive', 'Between March 19, 2020, and June 29, 2020, 1616 patients', 'patients admitted to hospital with COVID-19 (RECOVERY', '176 hospitals in the UK', 'Eligible and consenting patients', 'patients admitted to hospital with COVID-19']","['Lopinavir-ritonavir', 'usual standard of care alone or usual standard of care plus lopinavir-ritonavir', 'lopinavir-ritonavir', 'usual care', 'hydroxychloroquine, dexamethasone, or azithromycin']","['time until discharge alive from hospital', '28-day mortality, duration of hospital stay, or risk of progressing to invasive mechanical ventilation or death', '28-day all-cause mortality', 'composite endpoint of invasive mechanical ventilation or death']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C2711213', 'cui_str': 'Consented'}]","[{'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205199', 'cui_str': 'Composite'}]",1616.0,0.208399,"Among patients not on invasive mechanical ventilation at baseline, there was no significant difference in the proportion who met the composite endpoint of invasive mechanical ventilation or death (risk ratio 1·09, 95% CI 0·99-1·20; p=0·092).
","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(20)32013-4']
3139,33031860,Believing is achieving - On the role of treatment expectation in neurofeedback applications.,"In neurofeedback applications, neural activity is recorded, processed in real-time and fed back to the user in order to facilitate self-regulation of the putative neural mechanisms that underlie cognition and behavior. Numerous studies suggest that neurofeedback interventions are an efficacious treatment particularly for patients with attention-deficit/hyperactivity disorder (ADHD). In recent years, however, findings of several well-controlled studies raised doubts concerning the proposed mechanism of action behind the behavioral effect of neurofeedback. This study investigated the impact of expectation on the efficacy of a sensorimotor rhythm (SMR) training. In a within-subjects design 30 blinded volunteers with ADHD symptoms received a standard SMR training session after inducing no (no-expectancy condition), positive (placebo condition), and negative (nocebo condition) expectations regarding the effectiveness of neurofeedback (by telling them that they would train a specific frequency band that was previously shown to be either unrelated to attention, should improve attention, or interfere with attentional processes). After each training, participants were presented with a cognitive test and subsequently requested to rate their performance on it. We could show that participants were able to successfully modify their EEG signal during training. Further, we found an effect over trainings on objective attentional performance. Most importantly, we found that the expectancy of positive or negative treatment effects considerably changed participants' perception of neurofeedback's efficacy even in the absence of any objective evidence. This study presents strong first evidence for a substantial effect of self-confirming response expectancies as one factor underlying the efficacy of neurofeedback. Future research has to carefully consider the impact of such psychosocial mechanisms when evaluating the (specific) efficacy of neuromodulatory treatments.",2020,"Most importantly, we found that the expectancy of positive or negative treatment effects considerably changed participants' perception of neurofeedback's efficacy even in the absence of any objective evidence.",['patients with attention-deficit/hyperactivity disorder (ADHD'],"['standard SMR training session after inducing no (no-expectancy condition), positive (placebo condition), and negative (nocebo condition) expectations', 'sensorimotor rhythm (SMR) training', 'neurofeedback interventions']",['objective attentional performance'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C3658218', 'cui_str': 'Nocebo'}, {'cui': 'C2713543', 'cui_str': 'Electroencephalographic biofeedback'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}]",30.0,0.0296425,"Most importantly, we found that the expectancy of positive or negative treatment effects considerably changed participants' perception of neurofeedback's efficacy even in the absence of any objective evidence.","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schönenberg', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Germany. Electronic address: michael.schoenenberg@uni-tuebingen.de.'}, {'ForeName': 'Anna-Lena', 'Initials': 'AL', 'LastName': 'Weingärtner', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Germany.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Weimer', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, Ulm University Medical Center, Germany.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Scheeff', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Germany.'}]",Progress in neuro-psychopharmacology & biological psychiatry,['10.1016/j.pnpbp.2020.110129']
3140,33032009,Step-stress vs. staircase fatigue tests to evaluate the effect of intaglio adjustment on the fatigue behavior of simplified lithium disilicate glass-ceramic restorations.,"The aim of the study was to compare the outcomes for the fatigue mechanical behavior of bonded simplified lithium disilicate restorations, with and without an internal adjustment by grinding with diamond bur in running two fatigue tests: Staircase and Step-stress testing approaches. Ceramic discs (IPS e.max CAD) were prepared (Ø = 10 mm; thickness = 1.0 mm), submitted to an in-lab simulation of CAD/CAM milling (#60 SiC paper) and allocated into 2 groups according to the internal adjustment by grinding of the cementation surface: no adjustment (CTRL); or grinding with a coarse diamond bur (GR). Adhesive cementation (Multilink N) was performed onto epoxy resin discs (Ø = 10 mm; thickness = 2 mm) after ceramic/epoxy surface treatments. The cemented assemblies of each group were randomly assigned into 2 subgroups considering two fatigue tests (n = 15): Staircase - SC (250,000 cycles; 20 Hz), or Step-stress - SS (10,000 cycles per step; 20 Hz). Roughness, topographic and fractographic analyses were additionally performed. Statistical analyses were carried out using the Dixon and Mood method for Staircase data, and Kaplan-Meier and Mantel-Cox (log-rank) tests for Step-stress data. Ceramic restorations having its intaglio surface ground (GR group: SC test = 306.67 N; SS test = 646.67 N) presented lower fatigue failure load (FFL) values than the CTRL group (SC test = 879.28 N; SS test = 1090.00 N), regardless of the fatigue testing approach. The percentage of mean FFL decrease comparing the CTRL to GR group was higher for SC (65.1%) than the SS (40.7%) approach. However, a different total number of cycles was applied for each method. Both fatigue tests were able to detect the negative effect of internal adjustments of lithium disilicate glass-ceramic simplified restorations on their mechanical behavior. Therefore, both methods can be applied for similar evaluations (fatigue testing for ceramic restorations).",2020,Both fatigue tests were able to detect the negative effect of internal adjustments of lithium disilicate glass-ceramic simplified restorations on their mechanical behavior.,[],"['Staircase - SC (250,000 cycles; 20\xa0Hz), or Step-stress - SS', 'Adhesive cementation (Multilink N', 'internal adjustment by grinding of the cementation surface: no adjustment (CTRL); or grinding with a coarse diamond bur (GR', 'Ceramic discs (IPS e.max CAD']","['percentage of mean FFL decrease', 'Roughness, topographic and fractographic analyses', 'fatigue failure load (FFL) values']",[],"[{'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0001516', 'cui_str': 'Adhesive'}, {'cui': 'C0007656', 'cui_str': 'Cementation'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0185051', 'cui_str': 'Removal by grinding'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0205194', 'cui_str': 'Coarse'}, {'cui': 'C0057717', 'cui_str': 'Diamond'}, {'cui': 'C0700351', 'cui_str': 'Bur'}, {'cui': 'C0007742', 'cui_str': 'Ceramic'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C1504431', 'cui_str': 'Idiopathic pneumonia syndrome'}, {'cui': 'C0011905', 'cui_str': 'Computer-Assisted Diagnosis'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.0283014,Both fatigue tests were able to detect the negative effect of internal adjustments of lithium disilicate glass-ceramic simplified restorations on their mechanical behavior.,"[{'ForeName': 'Andressa Borin', 'Initials': 'AB', 'LastName': 'Venturini', 'Affiliation': 'MSciD and PhD Post-Graduate Program in Oral Science, Faculty of Dentistry, Federal University of Santa Maria (UFSM), Santa Maria, Rio Grande do Sul State, Brazil. Electronic address: andressa.venturini@hotmail.com.'}, {'ForeName': 'Thaís Camponogara', 'Initials': 'TC', 'LastName': 'Bohrer', 'Affiliation': 'MSciD and PhD Post-Graduate Program in Oral Science, Faculty of Dentistry, Federal University of Santa Maria (UFSM), Santa Maria, Rio Grande do Sul State, Brazil. Electronic address: thaiscbohrer@hotmail.com.'}, {'ForeName': 'Patrícia Eliana', 'Initials': 'PE', 'LastName': 'Fontana', 'Affiliation': 'MSciD and PhD Post-Graduate Program in Oral Science, Faculty of Dentistry, Federal University of Santa Maria (UFSM), Santa Maria, Rio Grande do Sul State, Brazil. Electronic address: patricia_fontana_@hotmail.com.'}, {'ForeName': 'Tatiana Tambara', 'Initials': 'TT', 'LastName': 'Fröhlich', 'Affiliation': 'MSciD and PhD Post-Graduate Program in Oral Science, Faculty of Dentistry, Federal University of Santa Maria (UFSM), Santa Maria, Rio Grande do Sul State, Brazil. Electronic address: frohlichtatiana@gmail.com.'}, {'ForeName': 'Liliana Gressler', 'Initials': 'LG', 'LastName': 'May', 'Affiliation': 'MSciD and PhD Post-Graduate Program in Oral Science, Faculty of Dentistry, Federal University of Santa Maria (UFSM), Santa Maria, Rio Grande do Sul State, Brazil. Electronic address: liligmay@gmail.com.'}, {'ForeName': 'Luiz Felipe', 'Initials': 'LF', 'LastName': 'Valandro', 'Affiliation': 'MSciD and PhD Post-Graduate Program in Oral Science, Faculty of Dentistry, Federal University of Santa Maria (UFSM), Santa Maria, Rio Grande do Sul State, Brazil. Electronic address: valandrolf@gmail.com.'}]",Journal of the mechanical behavior of biomedical materials,['10.1016/j.jmbbm.2020.104091']
3141,33032123,"The effect of emergency manuals on team performance during two different simulated perioperative crises: A prospective, randomized controlled trial.","STUDY OBJECTIVE


Whether having an emergency manual (EM) available for use during perioperative crises enhances or detracts from team performance, especially for multi-factorial diagnostic situations that do not explicitly match a chapter of the EM.
DESIGN


A simulation-based, prospective randomized trial based upon two perioperative crises, one involving a patient with a transfusion reaction for which the EM contains a specific chapter, and the other involving a patient with refractory hypotension progressing into septic shock for which the EM does not have a specific chapter.
SETTING


52 regularly scheduled 6-h courses at the Center for Medical Simulation in Boston, Massachusetts, USA.
STUDY GROUP


304 US-trained practicing anesthesiologists.
INTERVENTIONS


The absence or presence of the EM during the simulation case.
MEASUREMENTS


Teams were rated in the following categories: primary underlying diagnosis, fluid resuscitation, treatment of primary diagnosis, cardiac arrest management, overall crisis management, and (if applicable) EM usage. Also, raters recorded free-text 'field notes' about the usage-patterns and perceived utility of the EM. Using these 'field notes' and a two-stage, inductively revised procedure, two independent reviewers examined a subset of case videos for action analysis.
MAIN RESULTS


Performance ratings for a total of 51 teams and 95 simulations were included in the final analysis. No effect on performance was demonstrated with providing the EM in either the refractory hypotension/septic shock case or the transfusion reaction case, with the exception of the PEA arrest category. In the subset of simulations in which resuscitation from PEA arrest performance could be evaluated, EM availability was associated with an adjusted mean 1.3 point (99% confidence interval [CI]: 0.2, 2.4) improvement in performance in the transfusion reaction case (p = 0.004), but only an adjusted mean 0.2 point (99% CI, -0.7, 1.1) improvement in the refractory hypotension/septic shock case (p = 0.530) (p for interaction = 0.069). Analysis of actions found that when available, the EM was usually used, but often not until after cardiac arrest had occurred. In some cases, teams persisted with incorrect diagnoses and treatments irrespective of the presence or absence of an EM.
CONCLUSIONS


Providing an EM did not affect team performance in areas like diagnosis, treatment, fluid resuscitation, communication, and teamwork in management of perioperative crises such as transfusion reaction where an explicit chapter in the EM exists and refractory hypotension / septic shock where an explicit chapter does not exist. A suggestion of improved cardiac arrest resuscitation with the availability of an EM was found, but should be interpreted with caution given a limited sample size. Observed actions using the EM demonstrated that only about half of the teams used the EM to any substantive degree and most used it relatively late in the crisis. By observation, the EM appeared to be helpful in about half of the cases and did not, by itself, deter from appropriate management.",2020,"Providing an EM did not affect team performance in areas like diagnosis, treatment, fluid resuscitation, communication, and teamwork in management of perioperative crises such as transfusion reaction where an explicit chapter in the EM exists and refractory hypotension / septic shock where an explicit chapter does not exist.","['patient with a transfusion reaction for which the EM contains a specific chapter, and the other involving a patient with refractory hypotension progressing into septic shock for which the EM does not have a specific chapter', 'two different simulated perioperative crises', '52']",[],"['diagnosis, fluid resuscitation, treatment of primary diagnosis, cardiac arrest management, overall crisis management, and (if applicable) EM usage', 'refractory hypotension/septic shock case', 'EM availability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0274435', 'cui_str': 'Blood transfusion reaction'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C4304283', 'cui_str': 'Refractory hypotension'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0231224', 'cui_str': 'Crisis'}]",[],"[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332137', 'cui_str': 'Principal diagnosis'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0231224', 'cui_str': 'Crisis'}, {'cui': 'C1272460', 'cui_str': 'Not applicable'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C4304283', 'cui_str': 'Refractory hypotension'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}]",52.0,0.125845,"Providing an EM did not affect team performance in areas like diagnosis, treatment, fluid resuscitation, communication, and teamwork in management of perioperative crises such as transfusion reaction where an explicit chapter in the EM exists and refractory hypotension / septic shock where an explicit chapter does not exist.","[{'ForeName': 'Richard D', 'Initials': 'RD', 'LastName': 'Urman', 'Affiliation': ""Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women's Hospital, Boston, MA, United States of America; Center for Perioperative Research, Brigham and Women's Hospitals, Boston, MA, United States of America. Electronic address: rurman@bwh.harvard.edu.""}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'August', 'Affiliation': 'Department of Anesthesia, Critical Care, and Pain Medicine, Massachusetts General Hospital, Boston, MA, United States of America.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Chung', 'Affiliation': ""Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'Amanda H', 'Initials': 'AH', 'LastName': 'Jiddou', 'Affiliation': ""Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Buckley', 'Affiliation': ""Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'Kara G', 'Initials': 'KG', 'LastName': 'Fields', 'Affiliation': ""Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'J Bradley', 'Initials': 'JB', 'LastName': 'Morrison', 'Affiliation': 'Brandeis International Business School, Waltham, MA, United States of America.'}, {'ForeName': 'Janice C', 'Initials': 'JC', 'LastName': 'Palaganas', 'Affiliation': 'Department of Anesthesia, Critical Care, and Pain Medicine, Massachusetts General Hospital, Boston, MA, United States of America.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Raemer', 'Affiliation': 'Department of Anesthesia, Critical Care, and Pain Medicine, Massachusetts General Hospital, Boston, MA, United States of America.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.110080']
3142,33032163,"Recovery using ""float"" from high intensity stress on growth hormone-like molecules in resistance trained men.","OBJECTIVE


The purpose of this study was to examine the influence of a novel ""floatation-restricted environmental stimulation therapy"" (floatation-REST) on growth hormone responses to an intense resistance exercise stress.
DESIGN


Nine resistance trained men (age: 23.4 ± 2.5 yrs.; height: 175.3 ± 5.4 cm; body mass: 85.3 ± 7.9 kg) completed a balanced, crossover-controlled study design with two identical exercise trials, differing only in post-exercise recovery intervention (i.e., control or floatation-REST). A two-week washout period was used between experimental conditions. Plasma lactate was measured pre-exercise, immediately post-exercise and after the 1 h. recovery interventions. Plasma iGH was measured pre-exercise, immediately-post exercise, and after the recovery intervention, as well as 24 h and 48 h after the exercise test. The bGH-L was measured only at pre-exercise and following each recovery intervention.
RESULTS


For both experimental conditions, a significant (P ≤ 0.05) increase in lactate concentrations were observed immediately post-exercise (~14 mmol • L-1) and remained slightly elevated after the recovery condition. The same pattern of responses was observed for iGH with no differences from resting values at 24 and 48 h of recovery. The bGH-L showed no exercise-induced changes following recovery with either treatment condition, however concentration values were dramatically lower than ever reported.
CONCLUSION


The use of floatation-REST therapy immediately following intense resistance exercise does not appear to influence anterior pituitary function in highly resistance trained men. However, the lower values of bGH suggest dramatically different molecular processing mechanisms at work in this highly trained population.",2020,"For both experimental conditions, a significant (P ≤ 0.05) increase in lactate concentrations were observed immediately post-exercise (","['Nine resistance trained men (age: 23.4\u202f±\u202f2.5\u202fyrs', '14', ' height: 175.3\u202f±\u202f5.4\u202fcm; body mass: 85.3\u202f±\u202f7.9\u202fkg', 'highly resistance trained men', 'resistance trained men']","['novel ""floatation-restricted environmental stimulation therapy"" (floatation-REST', 'floatation-REST therapy', 'exercise recovery intervention (i.e., control or floatation-REST']","['Plasma iGH', 'bGH-L', 'Plasma lactate', 'lactate concentrations', 'concentration values']","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517655', 'cui_str': '23.4'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C4517792', 'cui_str': '5.4'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0017351', 'cui_str': 'Immunoglobulin gene GM allotype'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",9.0,0.0688166,"For both experimental conditions, a significant (P ≤ 0.05) increase in lactate concentrations were observed immediately post-exercise (","[{'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Kraemer', 'Affiliation': 'Department of Human Sciences, The Ohio State University, Columbus, OH 43210, United States of America. Electronic address: kraemer.44@osu.edu.'}, {'ForeName': 'Lydia K', 'Initials': 'LK', 'LastName': 'Caldwell', 'Affiliation': 'Department of Human Sciences, The Ohio State University, Columbus, OH 43210, United States of America.'}, {'ForeName': 'Emily M', 'Initials': 'EM', 'LastName': 'Post', 'Affiliation': 'Department of Human Sciences, The Ohio State University, Columbus, OH 43210, United States of America.'}, {'ForeName': 'Matthew K', 'Initials': 'MK', 'LastName': 'Beeler', 'Affiliation': 'Department of Human Sciences, The Ohio State University, Columbus, OH 43210, United States of America.'}, {'ForeName': 'Ryan M', 'Initials': 'RM', 'LastName': 'Dickerson', 'Affiliation': 'Department of Human Sciences, The Ohio State University, Columbus, OH 43210, United States of America.'}, {'ForeName': 'Mary J', 'Initials': 'MJ', 'LastName': 'Kennett', 'Affiliation': 'Department of Veterinary and Biomedical Sciences, The Pennsylvania State University, University Park, PA 16802, United States of America.'}, {'ForeName': 'Jeff S', 'Initials': 'JS', 'LastName': 'Volek', 'Affiliation': 'Department of Human Sciences, The Ohio State University, Columbus, OH 43210, United States of America.'}, {'ForeName': 'Carl M', 'Initials': 'CM', 'LastName': 'Maresh', 'Affiliation': 'Department of Human Sciences, The Ohio State University, Columbus, OH 43210, United States of America.'}, {'ForeName': 'Wesley C', 'Initials': 'WC', 'LastName': 'Hymer', 'Affiliation': 'Department of Biochemistry and Molecular Biology, The Pennsylvania State University, University Park, PA 16802, United States of America.'}]",Growth hormone & IGF research : official journal of the Growth Hormone Research Society and the International IGF Research Society,['10.1016/j.ghir.2020.101355']
3143,33032164,"Exploring the impact of a liquefied petroleum gas intervention on time use in rural Peru: A mixed methods study on perceptions, use, and implications of time savings.","BACKGROUND


Efforts to promote clean cooking through adoption of clean-burning fuels such as liquefied petroleum gas (LPG) are often based on the idea that near-exclusive use of LPG could lead to health improvements. However, benefits beyond health, such as time savings, could be more tangible and meaningful to LPG users.
OBJECTIVES


This study investigated the effect of an LPG intervention on time spent cooking and collecting fuel, using objective measures of stove temperatures combined with self-reports under conditions of near-exclusive LPG use. We also investigated the perceived value of any time savings and potential economic and quality of life implications.
METHODS


We analyzed data from the Cardiopulmonary outcomes and Household Air Pollution trial in Puno, Peru, a randomized controlled trial with 180 participants assessing exposure and health impacts of an LPG stove, fuel, and behavioral intervention. Surveys conducted with 90 intervention women receiving free LPG and 90 control women cooking primarily with biomass assessed time spent cooking and collecting biomass fuel and use of time savings. Cooking time was objectively measured with temperature sensors on all stoves. Qualitative interviews explored perceptions and use of time savings in more depth.
RESULTS


Intervention women spent 3.2 fewer hours cooking and 1.9 fewer hours collecting fuel per week compared to control women, but cooked on average 1.0 more meals per day. Participants perceived time saved from LPG positively, reporting more time for household chores, leisure activities, and activities with income-generating potential such as caring for animals and working in fields.
DISCUSSION


This paper suggests that the benefits of LPG extend beyond health and the environment. LPG use could also lead to economic and quality of life gains, through increased time for work, rest, and consumption of hot meals, and reduced arduous biomass fuel collection.",2020,"RESULTS


Intervention women spent 3.2 fewer hours cooking and 1.9 fewer hours collecting fuel per week compared to control women, but cooked on average 1.0 more meals per day.","['180 participants assessing exposure and health impacts of an LPG stove, fuel, and behavioral intervention', '90 intervention women receiving free LPG and 90 control women cooking primarily with biomass assessed', 'rural Peru']","['LPG', 'liquefied petroleum gas intervention', 'LPG intervention']","['time for work, rest, and consumption of hot meals, and reduced arduous biomass fuel collection', 'time spent cooking and collecting biomass fuel and use of time savings', 'time saved from LPG positively, reporting more time for household chores, leisure activities, and activities with income-generating potential such as caring for animals and working in fields', 'Cooking time', 'time savings and potential economic and quality of life implications']","[{'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0303763', 'cui_str': 'Liquefied petroleum gas'}, {'cui': 'C0336754', 'cui_str': 'Stove'}, {'cui': 'C0556991', 'cui_str': 'Fuel'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C0005535', 'cui_str': 'Biomass'}, {'cui': 'C0031238', 'cui_str': 'Peru'}]","[{'cui': 'C0303763', 'cui_str': 'Liquefied petroleum gas'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0444519', 'cui_str': 'Hot'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0005535', 'cui_str': 'Biomass'}, {'cui': 'C0556991', 'cui_str': 'Fuel'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0036245', 'cui_str': 'Savings'}, {'cui': 'C0303763', 'cui_str': 'Liquefied petroleum gas'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0023292', 'cui_str': 'Leisure Activities'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0003062', 'cui_str': 'Kingdom Animalia'}, {'cui': 'C0557351', 'cui_str': 'Employed'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",180.0,0.0503954,"RESULTS


Intervention women spent 3.2 fewer hours cooking and 1.9 fewer hours collecting fuel per week compared to control women, but cooked on average 1.0 more meals per day.","[{'ForeName': 'Kendra N', 'Initials': 'KN', 'LastName': 'Williams', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, School of Medicine, Johns Hopkins University, Baltimore, MD, USA; Center for Global Non-Communicable Disease Research and Training, Johns Hopkins University, Baltimore, MD, USA. Electronic address: kendra.williams@jhu.edu.'}, {'ForeName': 'Josiah L', 'Initials': 'JL', 'LastName': 'Kephart', 'Affiliation': 'Center for Global Non-Communicable Disease Research and Training, Johns Hopkins University, Baltimore, MD, USA; Department of Environmental Health and Engineering, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Fandiño-Del-Rio', 'Affiliation': 'Center for Global Non-Communicable Disease Research and Training, Johns Hopkins University, Baltimore, MD, USA; Department of Environmental Health and Engineering, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Suzanne M', 'Initials': 'SM', 'LastName': 'Simkovich', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, School of Medicine, Johns Hopkins University, Baltimore, MD, USA; Center for Global Non-Communicable Disease Research and Training, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Koehler', 'Affiliation': 'Department of Environmental Health and Engineering, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Harvey', 'Affiliation': 'Department of International Health, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Checkley', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, School of Medicine, Johns Hopkins University, Baltimore, MD, USA; Center for Global Non-Communicable Disease Research and Training, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Environment international,['10.1016/j.envint.2020.105932']
3144,33032180,A prospective randomized controlled trial on the value of prophylactic oral nutritional supplementation in locally advanced nasopharyngeal carcinoma patients receiving chemo-radiotherapy.,"OBJECTIVES


We investigated the effect of prophylactic oral nutrition supplements (ONS) in locally advanced nasopharyngeal carcinoma patients receiving neoadjuvant chemotherapy and concurrent chemoradiotherapy (CCRT).
METHODS


Eligible patients were randomly assigned to an intervention or control group. Patients in the intervention group were supported with prophylactic ONS from the beginning of CCRT. The control group received nutritional support only when necessary. Bodyweight, hematological indexes, nutritional status, and quality of life were measured at baseline and before, during, and after RT.
RESULTS


We evaluated 114 patients from October 2016 to May 2018. More than half of patients experienced significant weight loss during CCRT, which continued for three months after radiotherapy (RT). Compared to baseline, the rate of weight loss ≥ 5% before, during, at the end of RT, and one and three months after RT were 3.5%, 28.9%, 51.8%, 61.4%, and 61.4%, respectively. Nutritional status and global health status scores progressively decreased during treatment. The rate of RT interruption was higher in the control group than in the intervention group (7.14% vs. 0%, χ 2  = 4.29, P = 0.04). More patients experienced concurrent chemotherapy interruption in the control group than in the intervention group (28.57% vs 10.34%, χ 2  = 6.08, P = 0.01). There were no significant differences in weight loss, nutritional status, quality of life, and global health status between two groups.
CONCLUSIONS


Malnutrition and weight loss progressively increased during treatment. Prophylactic ONS can improve tolerance to CCRT, but it offers no advantage on short-term weight loss or nutritional assessment scores.",2020,"There were no significant differences in weight loss, nutritional status, quality of life, and global health status between two groups.
","['locally advanced nasopharyngeal carcinoma patients receiving', 'Eligible patients', 'locally advanced nasopharyngeal carcinoma patients receiving neoadjuvant chemotherapy and concurrent chemoradiotherapy (CCRT', '114 patients from October 2016 to May 2018']","['Prophylactic ONS', 'prophylactic oral nutrition supplements (ONS', 'chemo-radiotherapy', 'prophylactic ONS', 'nutritional support', 'prophylactic oral nutritional supplementation']","['weight loss', 'Nutritional status and global health status scores', 'concurrent chemotherapy interruption', 'rate of weight loss', 'rate of RT interruption', 'Bodyweight, hematological indexes, nutritional status, and quality of life', 'weight loss, nutritional status, quality of life, and global health status']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C2931822', 'cui_str': 'Nasopharyngeal carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3178775', 'cui_str': 'Concomitant Radiochemotherapy'}, {'cui': 'C4708785', 'cui_str': '114'}]","[{'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0392920', 'cui_str': 'Antineoplastic chemotherapy regimen'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0242739', 'cui_str': 'Nutritional support'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",114.0,0.0467853,"There were no significant differences in weight loss, nutritional status, quality of life, and global health status between two groups.
","[{'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Huang', 'Affiliation': 'Department of Head and Neck Radiotherapy, Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Institute of Cancer and Basic Medicine (ICBM) Chinese Academy of Sciences, Zhejiang Province Key Laboratory of Radiation Oncology, 1st Banshan Road, Gongshu District, Hangzhou 310000, China. Electronic address: huangshuang@zjcc.org.cn.'}, {'ForeName': 'Yongfeng', 'Initials': 'Y', 'LastName': 'Piao', 'Affiliation': 'Department of Head and Neck Radiotherapy, Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Institute of Cancer and Basic Medicine (ICBM) Chinese Academy of Sciences, Zhejiang Province Key Laboratory of Radiation Oncology, 1st Banshan Road, Gongshu District, Hangzhou 310000, China.'}, {'ForeName': 'Caineng', 'Initials': 'C', 'LastName': 'Cao', 'Affiliation': 'Department of Head and Neck Radiotherapy, Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Institute of Cancer and Basic Medicine (ICBM) Chinese Academy of Sciences, Zhejiang Province Key Laboratory of Radiation Oncology, 1st Banshan Road, Gongshu District, Hangzhou 310000, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Hangzhou YITU Healthcare Technology Co., Ltd, Xihu District, Hangzhou 310012, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Sheng', 'Affiliation': 'Hangzhou YITU Healthcare Technology Co., Ltd, Xihu District, Hangzhou 310012, China.'}, {'ForeName': 'Zekai', 'Initials': 'Z', 'LastName': 'Shu', 'Affiliation': 'The 2nd Clinical Medical College of Zhejiang, Chinese Medical University, No. 534, Binwen Road, Hangzhou 310053, China.'}, {'ForeName': 'Yonghong', 'Initials': 'Y', 'LastName': 'Hua', 'Affiliation': 'Department of Head and Neck Radiotherapy, Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Institute of Cancer and Basic Medicine (ICBM) Chinese Academy of Sciences, Zhejiang Province Key Laboratory of Radiation Oncology, 1st Banshan Road, Gongshu District, Hangzhou 310000, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Jiang', 'Affiliation': 'Department of Head and Neck Radiotherapy, Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Institute of Cancer and Basic Medicine (ICBM) Chinese Academy of Sciences, Zhejiang Province Key Laboratory of Radiation Oncology, 1st Banshan Road, Gongshu District, Hangzhou 310000, China.'}, {'ForeName': 'Qiaoying', 'Initials': 'Q', 'LastName': 'Hu', 'Affiliation': 'Department of Head and Neck Radiotherapy, Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Institute of Cancer and Basic Medicine (ICBM) Chinese Academy of Sciences, Zhejiang Province Key Laboratory of Radiation Oncology, 1st Banshan Road, Gongshu District, Hangzhou 310000, China.'}, {'ForeName': 'Xiaozhong', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Head and Neck Radiotherapy, Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Institute of Cancer and Basic Medicine (ICBM) Chinese Academy of Sciences, Zhejiang Province Key Laboratory of Radiation Oncology, 1st Banshan Road, Gongshu District, Hangzhou 310000, China.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Head and Neck Radiotherapy, Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Institute of Cancer and Basic Medicine (ICBM) Chinese Academy of Sciences, Zhejiang Province Key Laboratory of Radiation Oncology, 1st Banshan Road, Gongshu District, Hangzhou 310000, China. Electronic address: chenyy@zjcc.org.cn.'}]",Oral oncology,['10.1016/j.oraloncology.2020.105025']
3145,33032234,Periodontal treatment and vascular inflammation in patients with advanced peripheral arterial disease: A randomized controlled trial.,"BACKGROUND AND AIMS


Observational studies support an association between periodontitis and cardiovascular diseases. The study objective was to assess vascular inflammation after periodontal treatment in patients with peripheral arterial disease.
METHODS


Ninety patients with peripheral arterial disease (PAD) and severe periodontitis were enrolled in a randomized, controlled trial. Thirty patients underwent non-surgical periodontal therapy and received additional systemic antibiotics (PT1 group), while 30 patients received the same therapy without antibiotics (PT2 group). The remaining thirty patients did not receive periodontal therapy (CG, control group). The primary outcome of this treatment was a reduction in vascular inflammation three months after periodontal treatment as determined by  18 F-FDG PET/CT values. Secondary outcomes were changes in the inflamed periodontal surface area (PISA) and other periodontal parameters, changes in vascular biomarkers, and adverse cardiovascular events.
RESULTS


After three months of treatment, a significant improvement in periodontal health was observed in the treatment groups. However, no difference in the primary outcome in the aorta was observed in the three study groups (median target to background ratio follow-up/baseline, PT1 1.00; 95% CI 0.97-1.10, PT2 1.00; 95% CI 0.98-1.1, CG 1.1; 95% CI 0.99-1.1, p = 0.75). No significant differences were detected in most diseased segments and active segments. In addition, no differences were observed in  18 F-FDG uptake in the carotid, iliac, femoral, and popliteal arteries. No differences with regard to relative changes in vascular biomarkers were noted, and no serious cardiovascular adverse events occurred.
CONCLUSIONS


Periodontal treatment was effective and safe but did not reduce vascular inflammation in patients with PAD.",2020,"In addition, no differences were observed in  18 F-FDG uptake in the carotid, iliac, femoral, and popliteal arteries.","['Ninety patients with peripheral arterial disease (PAD) and severe periodontitis', 'patients with peripheral arterial disease', 'patients with PAD', 'patients with advanced peripheral arterial disease', 'Thirty patients underwent']","['non-surgical periodontal therapy and received additional systemic antibiotics (PT1 group), while 30 patients received the same therapy without antibiotics (PT2 group']","['vascular inflammation', 'periodontal health', 'serious cardiovascular adverse events', 'vascular biomarkers', 'reduction in vascular inflammation', 'inflamed periodontal surface area (PISA) and other periodontal parameters, changes in vascular biomarkers, and adverse cardiovascular events']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085096', 'cui_str': 'Peripheral vascular disease'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0332391', 'cui_str': 'pT1 category'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332392', 'cui_str': 'pT2 category'}]","[{'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",30.0,0.258351,"In addition, no differences were observed in  18 F-FDG uptake in the carotid, iliac, femoral, and popliteal arteries.","[{'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'Seinost', 'Affiliation': 'Division of Angiology, Department of Internal Medicine, Medical University of Graz, Austria. Electronic address: gerald.seinost@medunigraz.at.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Horina', 'Affiliation': 'Division of Angiology, Department of Internal Medicine, Medical University of Graz, Austria.'}, {'ForeName': 'Behrouz', 'Initials': 'B', 'LastName': 'Arefnia', 'Affiliation': 'Division of Operative Dentistry, Periodontology and Prosthodontics, Department of Dental Medicine and Oral Health, Medical University of Graz, Austria.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Kulnik', 'Affiliation': 'Division of Nuclear Medicine Radiology, Department of Radiology, Medical University of Graz, Austria.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Kerschbaumer', 'Affiliation': 'Division of Nuclear Medicine Radiology, Department of Radiology, Medical University of Graz, Austria.'}, {'ForeName': 'Franz', 'Initials': 'F', 'LastName': 'Quehenberger', 'Affiliation': 'Institute for Medical Informatics, Statistics and Documentation, Medical University of Graz, Austria.'}, {'ForeName': 'Viktoria', 'Initials': 'V', 'LastName': 'Muster', 'Affiliation': 'Division of Angiology, Department of Internal Medicine, Medical University of Graz, Austria.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Gütl', 'Affiliation': 'Division of Angiology, Department of Internal Medicine, Medical University of Graz, Austria.'}, {'ForeName': 'Sieglinde', 'Initials': 'S', 'LastName': 'Zelzer', 'Affiliation': 'Clinical Institute of Medical and Chemical Laboratory Diagnostics, Medical University of Graz, Austria.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Gasser', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Medical University of Graz, Austria.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Mangge', 'Affiliation': 'Clinical Institute of Medical and Chemical Laboratory Diagnostics, Medical University of Graz, Austria.'}, {'ForeName': 'Reingard', 'Initials': 'R', 'LastName': 'Aigner', 'Affiliation': 'Division of Nuclear Medicine Radiology, Department of Radiology, Medical University of Graz, Austria.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Brodmann', 'Affiliation': 'Division of Angiology, Department of Internal Medicine, Medical University of Graz, Austria.'}, {'ForeName': 'Gernot', 'Initials': 'G', 'LastName': 'Wimmer', 'Affiliation': 'Division of Operative Dentistry, Periodontology and Prosthodontics, Department of Dental Medicine and Oral Health, Medical University of Graz, Austria.'}]",Atherosclerosis,['10.1016/j.atherosclerosis.2020.09.019']
3146,33032256,Effects of familial Mediterranean fever on the middle ear.,"OBJECTIVE


To evaluate middle and inner ear function and hearing status of children with familial Mediterranean fever (FMF).
METHODS


We assigned 56 patients with FMF to the study group and 52 healthy volunteers to the control group. The mean age of patients in the study and control groups were 10.10 ± 3.70 and 9.77 ± 3.74 years, respectively. Physical examination and hearing evaluation were performed in both groups. The audiological test battery included 226-Hz tympanometry, pure tone audiometric evaluation, acoustic stapedial reflex measurements, distortion product otoacoustic emission recording, and wide-band tympanometry assessment.
RESULTS


The groups were similar in age and sex ratio (p > 0.05 for both comparisons). Pure tone audiogram and distortion product otoacoustic emission results were also similar for both groups (p > 0.05). The ipsilateral acoustic stapedial reflex were present in both of the groups and all participants had Type A tympanogram. The contralateral acoustic stapedial reflex thresholds were significantly higher in the familial Mediterranean fever group (p < 0.05 for all comparisons). The ambient and peak pressure absorbance values of wide-band tympanometry were significantly lower at 2000 Hz and significantly higher at 4000 Hz in the familial Mediterranean fever group (p < 0.05 for both comparisons). The severity and duration of disease adversely affected the absorbance values of wide-band tympanometry at 2000 and 4000 Hz (p < 0.05).
CONCLUSION


To our knowledge, this is the first study to demonstrate the adverse subclinical effects of familial Mediterranean fever on the middle ear. We recommend that children diagnosed with FMF should be closely monitored for future clinical middle ear pathologies.",2020,The ipsilateral acoustic stapedial reflex were present in both of the groups and all participants had Type A tympanogram.,"['56 patients with FMF to the study group and 52 healthy volunteers to the control group', 'familial Mediterranean fever on the middle ear', 'children with familial Mediterranean fever (FMF', 'children diagnosed with FMF']",[],"['contralateral acoustic stapedial reflex thresholds', 'ambient and peak pressure absorbance values of wide-band tympanometry', '226-Hz tympanometry, pure tone audiometric evaluation, acoustic stapedial reflex measurements, distortion product otoacoustic emission recording, and wide-band tympanometry assessment', 'absorbance values of wide-band tympanometry', 'Physical examination and hearing evaluation', 'ipsilateral acoustic stapedial reflex']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031069', 'cui_str': 'Familial Mediterranean fever'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013455', 'cui_str': 'Middle ear structure'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]",[],"[{'cui': 'C0441988', 'cui_str': 'Contralateral'}, {'cui': 'C0001166', 'cui_str': 'Acoustics'}, {'cui': 'C0428765', 'cui_str': 'Stapedial reflex threshold'}, {'cui': 'C0445174', 'cui_str': 'Peak pressure'}, {'cui': 'C1268822', 'cui_str': 'Optical density'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C0085853', 'cui_str': 'Tympanometry testing'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0034934', 'cui_str': 'Stapedial reflex'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0030976', 'cui_str': 'Distortions, Perceptual'}, {'cui': 'C0162525', 'cui_str': 'Spontaneous Otoacoustic Emissions'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral'}]",56.0,0.0334702,The ipsilateral acoustic stapedial reflex were present in both of the groups and all participants had Type A tympanogram.,"[{'ForeName': 'Asli Cakir', 'Initials': 'AC', 'LastName': 'Cetin', 'Affiliation': 'Department of Otorhinolaryngology, Dokuz Eylul University, School of Medicine, Izmir, Turkey. Electronic address: asli.cakir@deu.edu.tr.'}, {'ForeName': 'Ceyhun', 'Initials': 'C', 'LastName': 'Acari', 'Affiliation': 'Department of Pediatrics, Section of Immunology and Rheumatology, Dokuz Eylul University, School of Medicine, Izmir, Turkey. Electronic address: ceyhun.acari@deu.edu.tr.'}, {'ForeName': 'Hande', 'Initials': 'H', 'LastName': 'Evin', 'Affiliation': 'Department of Otorhinolaryngology, Unit of Speech, Hearing & Balance, Dokuz Eylul University, School of Medicine, Izmir, Turkey. Electronic address: handeevin1@gmail.com.'}, {'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Omer Ikiz', 'Affiliation': 'Department of Otorhinolaryngology, Dokuz Eylul University, School of Medicine, Izmir, Turkey. Electronic address: ahmet.ikiz@deu.edu.tr.'}, {'ForeName': 'Gunay', 'Initials': 'G', 'LastName': 'Kirkim', 'Affiliation': 'Department of Otorhinolaryngology, Unit of Speech, Hearing & Balance, Dokuz Eylul University, School of Medicine, Izmir, Turkey. Electronic address: gunay.kirkim@deu.edu.tr.'}, {'ForeName': 'Erbil', 'Initials': 'E', 'LastName': 'Unsal', 'Affiliation': 'Department of Pediatrics, Section of Immunology and Rheumatology, Dokuz Eylul University, School of Medicine, Izmir, Turkey. Electronic address: erbil.unsal@deu.edu.tr.'}]",International journal of pediatric otorhinolaryngology,['10.1016/j.ijporl.2020.110417']
3147,33034628,Effect of Fluorescence Visualization-Guided Surgery on Local Recurrence of Oral Squamous Cell Carcinoma: A Randomized Clinical Trial.,"Importance


High local recurrence rates with aggressive disease remain the main concern in oral cancer survival. Use of a translational device using fluorescence visualization (FV) approved by the US Food and Drug Administration and Health Canada, has shown a marked reduction in the 3-year local recurrence rate of high-grade oral lesions in a single-center observational study.
Objective


To determine whether FV- guided surgery can improve local control rates in the treatment of in situ or T1 to T2 category oral squamous cell carcinoma (OSCC).
Design, Setting, and Participants


A multicenter randomized clinical trial was conducted in a surgical setting. A total of 457 patients were enrolled between January 18, 2010, and April 30, 2015. Data analysis of the intention-to-treat population was performed from April 3, 2019, to March 20, 2020. Patients with histologically confirmed high-grade dysplasia/carcinoma in situ or T1 to T2 category OSCC were randomized to receive traditional peroral surgery or FV-guided surgery.
Intervention


Fluorescence visualization during surgery.
Main Outcomes and Measures


The primary outcome was local recurrence of OSCC. Secondary outcomes were failure of the first-pass margin, defined as a histologically confirmed positive margin for severe dysplasia or greater histologic change of the main specimen (ie, not the margins taken from the resection bed), regional or distant metastasis, and death due to disease.
Results


Of the 457 patients enrolled in the study, 443 patients (264 [59.6%] men; mean [SD] age, 61.5 [13.3] years) completed the randomized treatment: 227 FV-guided and 216 non-FV guided surgery. The median follow-up was 52 (range, 0.29-90.8) months. In total, 45 patients (10.2%) experienced local recurrence. The 3-year local recurrence rate was 9.4% in the FV-guided group and 7.2% in the non-FV group (difference, 2.2%; 95% CI, -3.2% to 7.4%). Other similarities between the FV vs non-FV groups included failure of first-pass margin (68/227 [30.0%]) vs 65/216 [30.1%]), regional failure (39/227 [17.2%] vs 37/216 [17.1%]), disease-specific survival (23/227 [10.1%] vs 19/26 [8.8%]), and overall survival (41/227 [18.1%] vs 38/216 [17.6%]) were also similar between groups. No adverse events were judged to be related to the intervention.
Conclusions and Relevance


In this randomized clinical trial, FV-guided surgery did not improve local control rates in the treatment of patients with in situ or T1 to T2 category oral cancer. Under a controlled environment, FV-guided surgery did not have an evident effect in reduction of local recurrence for localized OSCC. This result suggests that attention be directed to strategies other than improving definitions of nonapparent disease at clinical margins to identify the sources of local recurrence.
Trial Registration


ClinicalTrial.gov Identifier: NCT01039298.",2020,"Under a controlled environment, FV-guided surgery did not have an evident effect in reduction of local recurrence for localized OSCC.","['443 patients (264 [59.6%] men; mean [SD] age, 61.5 [13.3] years) completed the randomized treatment: 227', '457 patients were enrolled between January 18, 2010, and April 30, 2015', 'Oral Squamous Cell Carcinoma', 'Patients with histologically confirmed high-grade dysplasia/carcinoma in situ or T1 to T2 category OSCC', 'patients with in situ or T1 to T2 category oral cancer', 'in situ or T1 to T2 category oral squamous cell carcinoma (OSCC', '457 patients enrolled in the study']","['FV-guided surgery', 'Fluorescence Visualization-Guided Surgery', 'FV- guided surgery', 'FV-guided and 216 non-FV guided surgery', 'traditional peroral surgery or FV-guided surgery', 'translational device using fluorescence visualization (FV']","['failure of first-pass margin', '3-year local recurrence rate', 'adverse events', 'local recurrence', 'regional failure', 'failure of the first-pass margin, defined as a histologically confirmed positive margin for severe dysplasia or greater histologic change of the main specimen (ie, not the margins taken from the resection bed), regional or distant metastasis, and death due to disease', 'disease-specific survival', 'local control rates', 'local recurrence of OSCC', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0007137', 'cui_str': 'Squamous cell carcinoma'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0334044', 'cui_str': 'Dysplasia'}, {'cui': 'C0007099', 'cui_str': 'Carcinoma in situ'}, {'cui': 'C0475373', 'cui_str': 'T2 category'}, {'cui': 'C0444498', 'cui_str': 'In situ'}, {'cui': 'C0153381', 'cui_str': 'Malignant tumor of oral cavity'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0016315', 'cui_str': 'Fluorescence'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C4708905', 'cui_str': '216'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C1298904', 'cui_str': 'Device used'}]","[{'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0444693', 'cui_str': 'First pass'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C1709603', 'cui_str': 'Positive Surgical Margins'}, {'cui': 'C0334048', 'cui_str': 'Severe dysplasia'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C1269798', 'cui_str': 'pM category'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",457.0,0.202879,"Under a controlled environment, FV-guided surgery did not have an evident effect in reduction of local recurrence for localized OSCC.","[{'ForeName': 'J Scott', 'Initials': 'JS', 'LastName': 'Durham', 'Affiliation': 'Department of Surgery, Faculty of Medicine, The University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Penelope', 'Initials': 'P', 'LastName': 'Brasher', 'Affiliation': 'Department of Statistics, Faculty of Science, The University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Donald W', 'Initials': 'DW', 'LastName': 'Anderson', 'Affiliation': 'Department of Surgery, Faculty of Medicine, The University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Yoo', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery and Oncology, London Health Sciences Center, London, Ontario, Canada.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Hart', 'Affiliation': 'Division of Otolaryngology-Head and Neck Surgery, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Joseph C', 'Initials': 'JC', 'LastName': 'Dort', 'Affiliation': 'Division of Otolaryngology-Head and Neck Surgery, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Hadi', 'Initials': 'H', 'LastName': 'Seikaly', 'Affiliation': 'Division of Otolaryngology, Department of Surgery, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Kerr', 'Affiliation': 'Department of Otolaryngology-Head & Neck Surgery, Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Miriam P', 'Initials': 'MP', 'LastName': 'Rosin', 'Affiliation': 'School of Biomedical Physiology and Kinesiology, Simon Fraser University, Burnaby, British Columbia, Canada.'}, {'ForeName': 'Catherine F', 'Initials': 'CF', 'LastName': 'Poh', 'Affiliation': 'Department of Oral Biological and Medical Sciences, Faculty of Dentistry, The University of British Columbia, Vancouver, British Columbia, Canada.'}]",JAMA otolaryngology-- head & neck surgery,['10.1001/jamaoto.2020.3147']
3148,33034639,Effect of Patient Financial Incentives on Statin Adherence and Lipid Control: A Randomized Clinical Trial.,"Importance


Financial incentives can improve medication adherence and cardiovascular disease risk, but the optimal design to promote sustained adherence after incentives are discontinued is unknown.
Objective


To determine whether 6-month interventions involving different financial incentives to encourage statin adherence reduce low-density lipoprotein cholesterol (LDL-C) levels from baseline to 12 months.
Design, Setting, and Participants


This 4-group, randomized clinical trial was conducted from August 2013 to July 2018 among several large US insurer or employer populations and the University of Pennsylvania Health System. The study population included adults with elevated risk of cardiovascular disease, suboptimal LDL-C control, and evidence of imperfect adherence to statin medication. Data analysis was performed from July 2017 to June 2019.
Interventions


The interventions lasted 6 months during which all participants received daily medication reminders and an electronic pill bottle. Statin adherence was measured by opening the bottle. For participants randomized to the 3 intervention groups, adherence was rewarded with financial incentives. The sweepstakes group involved incentives for daily adherence. In the deadline sweepstakes group, incentives were reduced if participants were adherent only after a reminder. The sweepstakes plus deposit contract group split incentives between daily adherence and a monthly deposit reduced for each day of nonadherence.
Main Outcomes and Measures


The primary outcome was change in LDL-C level from baseline to 12 months.
Results


Among 805 participants randomized (199 in the simple daily sweepstakes group, 204 in the deadline sweepstakes group, 201 in the sweepstakes plus deposit contract group, and 201 in the control group), the mean (SD) age was 58.5 (10.3) years; 519 participants (64.5%) were women, 514 (63.9%) had diabetes, and 273 (33.9%) had cardiovascular disease. The mean (SD) baseline LDL-C level was 143.2 (42.5) mg/dL. Measured adherence at 6 months (defined as the proportion of 180 days with electronic pill bottle opening) in the control group (0.69; 95% CI, 0.66-0.72) was lower than that in the simple sweepstakes group (0.84; 95% CI, 0.81-0.87), the deadline sweepstakes group (0.86; 95% CI, 0.83-0.89), and the sweepstakes plus deposit contract group (0.87; 95% CI, 0.84-0.90) (P < .001 for each incentive group vs control). LDL-C levels were measured for 636 participants at 12 months. Mean LDL-C level reductions from baseline to 12 months were 33.6 mg/dL (95% CI, 28.4-38.8 mg/dL) in the control group, 32.4 mg/dL (95% CI, 27.3-37.6 mg/dL) in the sweepstakes group, 33.2 mg/dL (95% CI, 28.1-38.3 mg/dL) in the deadline sweepstakes group, and 36.5 mg/dL (95% CI, 31.3-41.7 mg/dL) in the sweepstakes plus deposit contract group (adjusted P > .99 for each incentive group vs control).
Conclusions and Relevance


Compared with the control group, different financial incentives improved measured statin adherence but not LDL-C levels. This result points to the importance of directly measuring health outcomes, rather than simply adherence, in trials aimed at improving health behaviors.
Trial Registration


ClinicalTrials.gov Identifier: NCT01798784.",2020,"Mean LDL-C level reductions from baseline to 12 months were 33.6 mg/dL (95% CI, 28.4-38.8 mg/dL) in the control group, 32.4 mg/","['August 2013 to July 2018 among several large US insurer or employer populations and the University of Pennsylvania Health System', '636 participants at 12 months', '805 participants randomized (199 in the simple daily sweepstakes group, 204 in the deadline sweepstakes group, 201 in the sweepstakes plus deposit contract group, and 201 in the control group), the mean (SD) age was 58.5 (10.3) years; 519 participants (64.5%) were women, 514 (63.9%) had diabetes, and 273 (33.9%) had cardiovascular disease', 'adults with elevated risk of cardiovascular disease, suboptimal LDL-C control, and evidence of imperfect adherence to statin medication']","['dL', 'daily medication reminders and an electronic pill bottle', 'Patient Financial Incentives']","['statin adherence', 'low-density lipoprotein cholesterol (LDL-C) levels', 'Statin Adherence and Lipid Control', 'Statin adherence', 'LDL-C levels', 'mean (SD) baseline LDL-C level', 'change in LDL-C level', 'Mean LDL-C level reductions']","[{'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0333562', 'cui_str': 'Deposition'}, {'cui': 'C0332522', 'cui_str': 'Contracts'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517519', 'cui_str': '10.3'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517718', 'cui_str': '33.9'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0179376', 'cui_str': 'Bottle'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}]","[{'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",805.0,0.18507,"Mean LDL-C level reductions from baseline to 12 months were 33.6 mg/dL (95% CI, 28.4-38.8 mg/dL) in the control group, 32.4 mg/","[{'ForeName': 'Iwan', 'Initials': 'I', 'LastName': 'Barankay', 'Affiliation': 'Department of Management, The Wharton School, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Peter P', 'Initials': 'PP', 'LastName': 'Reese', 'Affiliation': 'Center for Health Incentives and Behavioral Economics, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'Putt', 'Affiliation': 'Center for Health Incentives and Behavioral Economics, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Louise B', 'Initials': 'LB', 'LastName': 'Russell', 'Affiliation': 'Center for Health Incentives and Behavioral Economics, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Loewenstein', 'Affiliation': 'Center for Health Incentives and Behavioral Economics, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Pagnotti', 'Affiliation': 'Center for Health Incentives and Behavioral Economics, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Jiali', 'Initials': 'J', 'LastName': 'Yan', 'Affiliation': 'Center for Health Incentives and Behavioral Economics, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Jingsan', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Center for Health Incentives and Behavioral Economics, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'McGilloway', 'Affiliation': 'Department of Medicine and Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Troyen', 'Initials': 'T', 'LastName': 'Brennan', 'Affiliation': 'Department of Health Policy and Management, T. H. Chan School of Public Health, Harvard University, Boston, Massachusetts.'}, {'ForeName': 'Darra', 'Initials': 'D', 'LastName': 'Finnerty', 'Affiliation': 'Department of Medicine and Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Hoffer', 'Affiliation': 'Center for Health Incentives and Behavioral Economics, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Sakshum', 'Initials': 'S', 'LastName': 'Chadha', 'Affiliation': 'Rutgers New Jersey Medical School, Newark, New Jersey.'}, {'ForeName': 'Kevin G', 'Initials': 'KG', 'LastName': 'Volpp', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.19429']
3149,33018704,Intramuscular EMG For Abstract Myoelectric Control: A Proof Of Concept Study.,"Myoelectric prostheses are commonly controlled by surface EMG. Many control algorithms, including the user learning-based control paradigm abstract control, benefit from independent control signals. Measuring at the surface of the skin reduces the signal independence through cross talk. To increase the number of independent signals, intramuscular EMG recordings might be a viable alternative for myoelectric control. This proof of concept study investigated if real time abstract myoelectric control is possible with intramuscular measurements. Six participants performed a 4-target and 12-target abstract control task with both surface and intramuscular EMG recordings. The results suggest that intramuscular EMG is suitable for abstract control, and that performance could be increased in the future by stabilizing the amplitude of the processed intramuscular EMG signal.",2020,"The results suggest that intramuscular EMG is suitable for abstract control, and that performance could be increased in the future by stabilizing the amplitude of the processed intramuscular EMG signal.",[],"['Intramuscular EMG', 'intramuscular EMG', 'Abstract Myoelectric Control', '4-target and 12-target abstract control task with both surface and intramuscular EMG recordings']",[],[],"[{'cui': 'C0442117', 'cui_str': 'Intramuscular'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0000857', 'cui_str': 'Abstracting as Topic'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205148', 'cui_str': 'Surface'}]",[],6.0,0.0140845,"The results suggest that intramuscular EMG is suitable for abstract control, and that performance could be increased in the future by stabilizing the amplitude of the processed intramuscular EMG signal.","[{'ForeName': 'Sigrid S G', 'Initials': 'SSG', 'LastName': 'Dupan', 'Affiliation': ''}, {'ForeName': 'Agamemnon', 'Initials': 'A', 'LastName': 'Krasoulis', 'Affiliation': ''}, {'ForeName': 'Kianoush', 'Initials': 'K', 'LastName': 'Nazarpour', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/EMBC44109.2020.9175402']
3150,33018770,Effects of HD-tDCS combined with working memory training on event-related potentials.,"Transcranial direct current stimulation (tDCS) provides a non-invasive approach to modulate brain functions. Some studies have shown that tDCS combined with working memory training can alter the effect of training. This study aims to investigate the effect of HD-tDCS over the left dorsolateral prefrontal cortex combined with N-back task on the amplitude of event related potentials (ERP). In the experiment, subjects performed N-back training for 30min every day with active or sham tDCS for 10 days. EEG data were recorded when subjects performing N-back tests prior to the training, 1 day and 20 days post the training, respectively. With the analyses of ERP components, it was found that there were no significant differences between active and sham groups. However, the results of post-test were significantly different from the pre-test. Subsequently, both in active group and in sham group, the amplitude of ERP increased in the frontoparietal and occipital regions 1 day post training. Those alterations were enhanced 20 days post training in the active group but not in the sham group. The results indicated the aftereffect of HD-tDCS to promote the effects of cognitive training, showing accumulative positive aftereffects on ERP 20 days after the stimulation.",2020,"Subsequently, both in active group and in sham group, the amplitude of ERP increased in the frontoparietal and occipital regions 1 day post training.",[],"['Transcranial direct current stimulation (tDCS', 'HD-tDCS', 'HD-tDCS combined with working memory training']","['amplitude of event related potentials (ERP', 'event-related potentials', 'amplitude of ERP']",[],"[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0282171', 'cui_str': 'Event-related potentials'}]",,0.0366907,"Subsequently, both in active group and in sham group, the amplitude of ERP increased in the frontoparietal and occipital regions 1 day post training.","[{'ForeName': 'Linlin', 'Initials': 'L', 'LastName': 'Dong', 'Affiliation': ''}, {'ForeName': 'Yufeng', 'Initials': 'Y', 'LastName': 'Ke', 'Affiliation': ''}, {'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Xizi', 'Initials': 'X', 'LastName': 'Song', 'Affiliation': ''}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Ming', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/EMBC44109.2020.9176063']
3151,33018772,Effect of Long-term Transcranial Direct Current Stimulation on Glx and GABA: A Pilot Study.,"Previous studies have demonstrated that transcranial direct current stimulation (tDCS) over the dorsolateral prefrontal cortex (dlPFC) can enhance working memory. However, the mechanism underlying the long-term tDCS is still unclear. This pilot study aims to examine neurotransmitters such as gamma-aminobutyric (GABA) and Glx (a measure of glutamate and glutamine combined) and working memory in response to the long-term anodal tDCS over dlPFC. Six healthy, right-handed young adults enrolled in this study received 2-mA anodal tDCS over dlPFC within 4 weeks. Long-term tDCS means that it was applied 5 times per week for the first two weeks and once for the last two weeks with 30 min each time. The other six participants were enrolled as the control group without stimulation for testing the baseline enhancement of working memory due to learning. The GABA and Glx levels were assessed by Magnetic Resonance Spectroscopy (MRS), while a 3-back task was performed to assess working memory. Data were collected at the beginning of the experiment, after two-week tDCS and at the end of the experiment. We found that the working memory was not significantly enhanced by the first two-week tDCS because the accuracy of response in 3-back was not significantly increased compared to the control group. Meanwhile, there were no significant changes in the levels of GABA. However, the Glx level was found significantly decreased in both 2- and 4-week MRS measurements. The observation that the long-term tDCS causes the decrease of excitatory neurotransmitters implies the different underlying mechanisms between the long-term tDCS and the single one.",2020,We found that the working memory was not significantly enhanced by the first two-week tDCS because the accuracy of response in 3-back was not significantly increased compared to the control group.,"['Six healthy, right-handed young adults']","['2-mA anodal tDCS', 'Long-term Transcranial Direct Current Stimulation', 'transcranial direct current stimulation (tDCS']","['levels of GABA', 'GABA and Glx levels', 'Glx and GABA', 'accuracy of response in 3-back', 'working memory', 'Glx level']","[{'cui': 'C0230370', 'cui_str': 'Structure of right hand'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0016904', 'cui_str': 'Gamma-aminobutyric acid'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}]",6.0,0.0191738,We found that the working memory was not significantly enhanced by the first two-week tDCS because the accuracy of response in 3-back was not significantly increased compared to the control group.,"[{'ForeName': 'Haonan', 'Initials': 'H', 'LastName': 'Guan', 'Affiliation': ''}, {'ForeName': 'Yanyu', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': ''}, {'ForeName': 'Minmin', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Weidong', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Shaomin', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/EMBC44109.2020.9175996']
3152,33018792,The effect of transcranial alternating current stimulation (tACS) on cognitive function in older adults with dementia.,"Recent studies have shown a positive effect of transcranial alternating current stimulation (tACS), a noninvasive brain stimulation technique, on cognitive function of healthy individuals [1]. However, investigation into the effects of tACS on individuals with dementia or mild cognitive impairment (MCI) is lacking. In this pilot study, we investigated the hypothesis that following a regular schedule of challenging brain exercises combined with simultaneous tACS application would improve the working memory and cognitive function of older adults with memory impairments. Further, we explored whether pairing brain exercises with tACS would result in longer-lasting positive effects on cognitive function than brain exercises alone. A total of 17 older adults (12 males, 5 females, 70 ± 7 years), each with a diagnosis of mild to moderate dementia were enrolled in the study. All participants completed brain exercises in the lab on the following schedule: two 30-minute sessions per day, 5 days/week for 4 weeks consecutively. Eleven of the participants received brain exercises paired with tACS application at 40Hz. We evaluated cognitive function of the participants at baseline, post-intervention and 1-month followup using the Wechsler Memory Scale (WMS-IV) as an independent assessment of our brain exercises. Both the non-tACS and tACS groups significantly improved their WMS scores from baseline to post-intervention assessments. Comparison of the post-intervention and 1-month follow-up assessments indicated that the tACS group maintained their improvement significantly better than the non-tACS group.",2020,Both the non-tACS and tACS groups significantly improved their WMS scores from baseline to post-intervention assessments.,"['17 older adults (12 males, 5 females, 70 ± 7 years), each with a diagnosis of mild to moderate dementia were enrolled in the study', 'older adults with dementia', 'individuals with dementia or mild cognitive impairment (MCI', 'older adults with memory impairments']","['brain exercises paired with tACS application at 40Hz', 'brain exercises combined with simultaneous tACS application', 'pairing brain exercises with tACS', 'transcranial alternating current stimulation (tACS', 'tACS', 'brain exercises']","['WMS scores', 'cognitive function', 'working memory and cognitive function']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0233794', 'cui_str': 'Memory impairment'}]","[{'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C3852966', 'cui_str': 'Transcranial Alternating Current Stimulation'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}]","[{'cui': 'C0175702', 'cui_str': 'Williams syndrome'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}]",17.0,0.0406101,Both the non-tACS and tACS groups significantly improved their WMS scores from baseline to post-intervention assessments.,"[{'ForeName': 'Lonnie', 'Initials': 'L', 'LastName': 'Kehler', 'Affiliation': ''}, {'ForeName': 'Cristina O', 'Initials': 'CO', 'LastName': 'Francisco', 'Affiliation': ''}, {'ForeName': 'Maria A', 'Initials': 'MA', 'LastName': 'Uehara', 'Affiliation': ''}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Moussavi', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/EMBC44109.2020.9175903']
3153,33018842,Therapeutic Effects of an Anti-Gravity Treadmill (AlterG) Training on Neuromuscular Abnormalities Associated with Spasticity in Children with Cerebral Palsy .,"We aimed to characterize the therapeutic effects of Anti-Gravity Treadmill (AlterG) Training on neuromuscular abnormalities associated with spasticity in children with cerebral palsy (CP). Eighteen subjects were divided into two groups; AlterG and control. All subjects received up to 40 minutes of training 3 times a week for 8 weeks. The control group received conventional occupational therapy. The advanced parallel-cascade system identification technique was used to characterize the neuromuscular abnormalities associated with spasticity and separated its intrinsic and reflex components. Reflex stiffness gain (GR) and intrinsic stiffness gain (K) were used to track the therapeutic effects of training on neural and muscular abnormalities. Both K and GR were strongly positioned dependent; they varied linearly with the ankle angle at dorsiflexion. Their position dependence was quantified by fitting a linear model to K and GR over dorsiflexion positions. The evaluations were performed at four-time points; i.e. the baseline (before starting the training), 1 and 2 months after starting the training, and 1 month after the completion of the training to assess the persistent effects. We determined the changes in K and GR intercept and slope parameters over these 3 months to evaluate the therapeutic effects of training on neuromuscular abnormalities. The results revealed that all K and GR parameters decreased substantially following using AlterG training and these changes were greater than those observed in the control. The results also showed that these therapeutic effects were persistent to a high extent, particularly in the AlterG group. Our findings suggested that AlterG training could be considered as a robust therapeutic intervention to reduce neuromuscular abnormalities and manage spasticity.",2020,Reflex stiffness gain (GR) and intrinsic stiffness gain (K) were used to track the therapeutic effects of training on neural and muscular abnormalities.,"['children with cerebral palsy (CP', 'Children with Cerebral Palsy ', 'Eighteen subjects']","['conventional occupational therapy', 'Anti-Gravity Treadmill', 'AlterG training', 'AlterG) Training']","['Reflex stiffness gain (GR) and intrinsic stiffness gain (K', 'Neuromuscular Abnormalities', 'K and GR parameters']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C3715206', 'cui_str': '18'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C1318464', 'cui_str': 'Occupational therapy'}, {'cui': 'C0282189', 'cui_str': 'Gravity'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0034929', 'cui_str': 'Reflex'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",18.0,0.013676,Reflex stiffness gain (GR) and intrinsic stiffness gain (K) were used to track the therapeutic effects of training on neural and muscular abnormalities.,"[{'ForeName': 'Sh', 'Initials': 'S', 'LastName': 'Noroozi', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Mehrabi', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Lotfian', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Nooshiravan', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Shahroki', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Irani', 'Affiliation': ''}, {'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Mirbagheri', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/EMBC44109.2020.9175164']
3154,33019104,Development and Validation of a Predictive Model for Hemodynamic Responses to Resuscitation during Uncontrolled Hemorrhage .,"We investigated whether a statistical model could predict mean arterial pressure (MAP) during uncontrolled hemorrhage; such a model could be used for automated decision support, to help clinicians decide when to provide intravascular volume to achieve MAP goals. This was a secondary analysis of adult swine subjects during uncontrolled splenic bleeding. By protocol, after developing severe hypotension (MAP < 60 mmHg), subjects were resuscitated with either saline (NS) or fresh frozen plasma (FFP), determined randomly. Vital signs were documented at quasi-regular time-step intervals, until either subject death or 300 min. Subjects were randomly separated 50%/50% into training/validation sets, and regression models were developed to predict MAP for each subsequent (i.e., future) time-step. Median time-steps for serially recorded vital signs were +15 min. 5 subjects survived the protocol; 17 died after a median time of 87 min (IQR 78 - 134). The final model consisted of: current MAP; heart rate (HR); prior NS; imminent NS; and imminent FFP. The 95% limits-of-agreement between true subsequent MAP vs. predicted subsequent MAP were +10/-11 mmHg for the 79 time-steps in the training set; and +14/-13 for the 64 time-steps in the validation set. A total of 10 sudden death events (i.e., rapid, fatal MAP decrease within one single time-step) were excluded from analysis. In conclusion, for uncontrolled hemorrhage in a swine model, it was possible to estimate the next documented MAP value on the basis of the subject's current documented MAP; HR; prior NS; and the volume of resuscitation about to be administered. However, the model was unable to predict ""sudden death"" events. The applicability to populations with wider heterogeneity of hemorrhage patterns and with comorbidities requires further investigation.",2020,5 subjects survived the protocol; 17 died after a median time of 87 min (IQR 78 - 134).,['adult swine subjects during uncontrolled splenic bleeding'],['saline (NS) or fresh frozen plasma (FFP'],"['Median time-steps', 'mean arterial pressure (MAP']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0039005', 'cui_str': 'Suidae'}, {'cui': 'C0520745', 'cui_str': 'Splenic hemorrhage'}]","[{'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0016709', 'cui_str': 'Fresh frozen plasma'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}]",,0.0222451,5 subjects survived the protocol; 17 died after a median time of 87 min (IQR 78 - 134).,"[{'ForeName': 'Nicholas W', 'Initials': 'NW', 'LastName': 'Reisner', 'Affiliation': ''}, {'ForeName': 'Jeffrey T', 'Initials': 'JT', 'LastName': 'Peterson', 'Affiliation': ''}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Dubick', 'Affiliation': ''}, {'ForeName': 'Andrew T', 'Initials': 'AT', 'LastName': 'Reisner', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/EMBC44109.2020.9176141']
3155,33021047,"Academic performance of dental students: A randomised trial comparing live, audio recorded and video recorded lectures.","OBJECTIVES


To compare the academic performance of 4th-year dental students randomly divided into three learning groups: live lecture, video recorded lecture and audio recorded lecture. To assess students' attitudes towards the three learning methods.
MATERIALS AND METHODS


4th-year undergraduate students, enrolled in the Orthodontics Theory-1 course, were randomised into three groups receiving different teaching methods; video recorded lecture, audio recorded lecture and live lecture. Subjects were asked to answer two open-ended questions. The first was a simple basic knowledge question in which the answer involved transcribing information from the question, while the second required analytical thinking. Students were also asked to complete a questionnaire assessing their attitudes towards the three learning methods.
RESULTS


94 students participated in the study and were randomly allocated to each learning method. There were no significant differences in scores between the 3 study groups when answering the basic knowledge question (P > .05). The mean score for the analytic question was significantly higher for the live lecture and video recorded lecture groups compared to the audio recorded lecture group (P < .05). The majority of students agreed that lectures were an essential part of their learning experience and that lectures allowed interaction between students and lecturer. Two-thirds of students reported that watching a video recorded lecture provided a similar learning experience to attending a live lecture.
CONCLUSION


Video recorded, audio recorded and live lectures were found to be equally effective for providing basic knowledge. Video recorded and live lectures were more effective than audio recorded lecture at assessing higher levels of analytical thinking. Students attending video recorded lecture performed as well as those attending the live lecture.",2020,The mean score for the analytic question was significantly higher for the live lecture and video recorded lecture groups compared to the audio recorded lecture group (P<0.05).,"['4 th  year undergraduate students, enrolled in the Orthodontics Theory - 1 course', 'dental students', '94 students participated in the study']","['learning groups; live lecture, video recorded lecture, and audio recorded lecture', 'teaching methods; video recorded lecture, audio recorded lecture, and live-lecture']","['mean score for the analytic question', 'academic performance']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0038493', 'cui_str': 'Dental Student'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0039403', 'cui_str': 'Teaching Methods'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036373', 'cui_str': 'Academic Test Performance'}]",94.0,0.0222829,The mean score for the analytic question was significantly higher for the live lecture and video recorded lecture groups compared to the audio recorded lecture group (P<0.05).,"[{'ForeName': 'Abedalrahman J', 'Initials': 'AJ', 'LastName': 'Shqaidef', 'Affiliation': 'Department of Orthodontics, University of Jordan, Amman, Jordan.'}, {'ForeName': 'Dima', 'Initials': 'D', 'LastName': 'Abu-Baker', 'Affiliation': 'University of Jordan, Amman, Jordan.'}, {'ForeName': 'Zaid Bakri', 'Initials': 'ZB', 'LastName': 'Al-Bitar', 'Affiliation': 'Department Pediatric Dentistry and Orthodontics, University of Jordan, Amman, Jordan.'}, {'ForeName': 'Seren', 'Initials': 'S', 'LastName': 'Badran', 'Affiliation': 'Department Pediatric Dentistry and Orthodontics, University of Jordan, Amman, Jordan.'}, {'ForeName': 'Ahmad M', 'Initials': 'AM', 'LastName': 'Hamdan', 'Affiliation': 'Department Pediatric Dentistry and Orthodontics, University of Jordan, Amman, Jordan.'}]",European journal of dental education : official journal of the Association for Dental Education in Europe,['10.1111/eje.12614']
3156,33017456,"Effect of a 90 g/day low-carbohydrate diet on glycaemic control, small, dense low-density lipoprotein and carotid intima-media thickness in type 2 diabetic patients: An 18-month randomised controlled trial.","AIM


This study explored the effect of a moderate (90 g/d) low-carbohydrate diet (LCD) in type 2 diabetes patients over 18 months.
METHODS


Ninety-two poorly controlled type 2 diabetes patients aged 20-80 years with HbA1c ≥7.5% (58 mmol/mol) in the previous three months were randomly assigned to a 90 g/d LCD r traditional diabetic diet (TDD). The primary outcomes were glycaemic control status and change in medication effect score (MES). The secondary outcomes were lipid profiles, small, dense low-density lipoprotein (sdLDL), serum creatinine, microalbuminuria and carotid intima-media thickness (IMT).
RESULTS


A total of 85 (92.4%) patients completed 18 months of the trial. At the end of the study, the LCD and TDD group consumed 88.0±29.9 g and 151.1±29.8 g of carbohydrates, respectively (p < 0.05). The 18-month mean change from baseline was statistically significant for the HbA1c (-1.6±0.3 vs. -1.0±0.3%), 2-h glucose (-94.4±20.8 vs. -18.7±25.7 mg/dl), MES (-0.42±0.32 vs. -0.05±0.24), weight (-2.8±1.8 vs. -0.7±0.7 kg), waist circumference (-5.7±2.7 vs. -1.9±1.4 cm), hip circumference (-6.1±1.8 vs. -2.9±1.7 cm) and blood pressure (-8.3±4.6/-5.0±3 vs. 1.6±0.5/2.5±1.6 mmHg) between the LCD and TDD groups (p<0.05). The 18-month mean change from baseline was not significantly different in lipid profiles, sdLDL, serum creatinine, microalbuminuria, alanine aminotransferase (ALT) and carotid IMT between the groups.
CONCLUSIONS


A moderate (90 g/d) LCD showed better glycaemic control with decreasing MES, lowering blood pressure, decreasing weight, waist and hip circumference without adverse effects on lipid profiles, sdLDL, serum creatinine, microalbuminuria, ALT and carotid IMT than TDD for type 2 diabetic patients.",2020,"The 18-month mean change from baseline was not significantly different in lipid profiles, sdLDL, serum creatinine, microalbuminuria, alanine aminotransferase (ALT) and carotid IMT between the groups.
","['type 2 diabetic patients', 'type 2 diabetes patients over 18 months', 'Ninety-two poorly controlled type', '2 diabetes patients aged 20-80 years with HbA1c ≥7.5% (58 mmol/mol) in the previous three months']","['90 g/day low-carbohydrate diet', 'LCD r traditional diabetic diet (TDD', 'moderate (90 g/d) low-carbohydrate diet (LCD']","['weight', 'glycaemic control status and change in medication effect score (MES', 'blood pressure', 'lipid profiles, small, dense low-density lipoprotein (sdLDL), serum creatinine, microalbuminuria and carotid intima-media thickness (IMT', 'glycaemic control with decreasing MES, lowering blood pressure, decreasing weight, waist and hip circumference without adverse effects on lipid profiles, sdLDL, serum creatinine, microalbuminuria, ALT and carotid IMT', 'waist circumference', 'lipid profiles, sdLDL, serum creatinine, microalbuminuria, alanine aminotransferase (ALT) and carotid IMT', 'hip circumference', '2-h glucose', 'MES']","[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C4082119', 'cui_str': 'Three months'}]","[{'cui': 'C0439417', 'cui_str': 'g/24h'}, {'cui': 'C0259836', 'cui_str': 'Carbohydrate restricted diet'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0011878', 'cui_str': 'Diabetic diet'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0580105', 'cui_str': 'Change of medication'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1319171', 'cui_str': 'Medication response'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0439794', 'cui_str': 'Dense'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0730345', 'cui_str': 'Microalbuminuria'}, {'cui': 'C0162864', 'cui_str': 'Tunica intima'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0230097', 'cui_str': 'Structure of waist (surface region)'}, {'cui': 'C0562350', 'cui_str': 'Hip circumference'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}]",,0.106199,"The 18-month mean change from baseline was not significantly different in lipid profiles, sdLDL, serum creatinine, microalbuminuria, alanine aminotransferase (ALT) and carotid IMT between the groups.
","[{'ForeName': 'Chin-Ying', 'Initials': 'CY', 'LastName': 'Chen', 'Affiliation': 'Department of Family Medicine, National Taiwan University Hospital & National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Wei-Sheng', 'Initials': 'WS', 'LastName': 'Huang', 'Affiliation': 'Department of Family Medicine, National Taiwan University Hospital & National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Hui-Chuen', 'Initials': 'HC', 'LastName': 'Chen', 'Affiliation': 'Department of Dietetics, National Taiwan University Hospital & National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Chin-Hao', 'Initials': 'CH', 'LastName': 'Chang', 'Affiliation': 'Department of Medical Research, National Taiwan University Hospital & National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Long-Teng', 'Initials': 'LT', 'LastName': 'Lee', 'Affiliation': 'Department of Family Medicine, National Taiwan University Hospital & National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Heng-Shuen', 'Initials': 'HS', 'LastName': 'Chen', 'Affiliation': 'Department of Family Medicine, National Taiwan University Hospital & National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Yow-Der', 'Initials': 'YD', 'LastName': 'Kang', 'Affiliation': 'Department of Family Medicine, National Taiwan University Hospital & National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Wei-Chu', 'Initials': 'WC', 'LastName': 'Chie', 'Affiliation': 'Department of Public Health, College of Public Health, Institute of Epidemiology and Preventive Medicine, National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Chyi-Feng', 'Initials': 'CF', 'LastName': 'Jan', 'Affiliation': 'Department of Family Medicine, National Taiwan University Hospital & National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Wei-Dean', 'Initials': 'WD', 'LastName': 'Wang', 'Affiliation': 'Department of Family Medicine, National Taiwan University Hospital & National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Jaw-Shiun', 'Initials': 'JS', 'LastName': 'Tsai', 'Affiliation': 'Department of Family Medicine, National Taiwan University Hospital & National Taiwan University, Taipei, Taiwan.'}]",PloS one,['10.1371/journal.pone.0240158']
3157,33017484,Nivolumab-Induced Thrombotic Thrombocytopenic Purpura in a Patient with Anal Squamous Cell Carcinoma: A Lesson on Hematologic Toxicity from Immunotherapy.,"Thrombotic thrombocytopenic purpura (TTP) is a rare but life-threatening microangiopathic hemolytic anemia characterized by thrombocytopenia, hemolytic anemia, and ischemic organ damage. It is mainly caused by an autoreactive antibody directed at ADAMTS13. Immunotherapy is frequently associated with autoimmune complications in patients with cancer, but only three cases of TTP have been reported, none implicating single treatment with the anti-programmed cell death receptor 1 ligand antibody nivolumab. We present the first identified and reported case of nivolumab-associated TTP in a 51-year-old woman with stage IIIc anal carcinoma who achieved complete response following chemoradiation and received adjuvant nivolumab as part of a randomized clinical trial. Twelve weeks into treatment, she presented with dark urine, progressive fatigue, and headache. TTP diagnosis was based on laboratory evidence of hemolytic anemia, thrombocytopenia, and ADAMTS13 activity of 9% associated with an inhibitor. She was treated with daily plasma exchange and oral prednisone and responded well to treatment, with platelet counts over 100 K/cmm within 4 days. We reviewed and summarized data from all reported cases of TTP associated with cancer immunotherapy. We provide guidance on identification and management of this devastating hematologic complication, focusing on the importance of early recognition, as most patients achieve complete recovery with appropriate treatment. KEY POINTS: Thrombotic thrombocytopenic purpura (TTP) was originally excluded from previous reviews of hematologic immune-related adverse events; however, several cases have been reported in the past 2 years in patients treated with either single agent or combination of cytotoxic T-lymphocyte-associated antigen 4 and the programmed cell death receptor 1 (PD-1) or the PD-1 ligand inhibitors. Although rare, TTP is a life-threatening condition that could be challenging to diagnose, and early recognition is key as delayed treatment is associated with significant increase in mortality. The pathophysiology of immunotherapy-induced TTP is likely related to autoimmune inhibition of ADAMTS13; the addition of prednisone and rituximab to urgent plasmapheresis appears to be effective and should be part of the up-front management for these patients.",2020,"Thrombotic thrombocytopenic purpura (TTP) is a rare but life-threatening microangiopathic hemolytic anemia characterized by thrombocytopenia, hemolytic anemia and ischemic organ damage.","['cancer patients', '51-year-old woman with Stage IIIc anal carcinoma who achieved complete response following chemoradiation and received', 'Patient with Anal Squamous Cell Carcinoma']","['adjuvant nivolumab', 'daily plasma exchange and oral prednisone', 'Nivolumab-associated TTP', 'Nivolumab-Induced Thrombotic Thrombocytopenic Purpura', 'TTP', 'Immunotherapy']","['Thrombotic thrombocytopenic purpura (TTP', 'mortality', 'hemolytic anemia, thrombocytopenia, and ADAMTS13 activity', 'Hematologic Toxicity']","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0456608', 'cui_str': 'Stage 3C'}, {'cui': 'C0279637', 'cui_str': 'Anal cancer'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0349534', 'cui_str': 'Carcinoma of anal margin'}]","[{'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032113', 'cui_str': 'Plasma exchange'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0857305', 'cui_str': 'Thrombocytopenic purpura'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0034155', 'cui_str': 'Thrombotic thrombocytopenic purpura'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}]","[{'cui': 'C0034155', 'cui_str': 'Thrombotic thrombocytopenic purpura'}, {'cui': 'C0857305', 'cui_str': 'Thrombocytopenic purpura'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0002878', 'cui_str': 'Hemolytic anemia'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0018943', 'cui_str': 'Hematology'}, {'cui': 'C0040539', 'cui_str': 'TO'}]",,0.038954,"Thrombotic thrombocytopenic purpura (TTP) is a rare but life-threatening microangiopathic hemolytic anemia characterized by thrombocytopenia, hemolytic anemia and ischemic organ damage.","[{'ForeName': 'Mansour', 'Initials': 'M', 'LastName': 'Gergi', 'Affiliation': 'Department of Medicine, Division of Hematology & Oncology, Larner College of Medicine at the University of Vermont, Burlington, Vermont, USA.'}, {'ForeName': 'Kara K', 'Initials': 'KK', 'LastName': 'Landry', 'Affiliation': 'Department of Medicine, Division of Hematology & Oncology, Larner College of Medicine at the University of Vermont, Burlington, Vermont, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Ades', 'Affiliation': 'Department of Medicine, Division of Hematology & Oncology, Larner College of Medicine at the University of Vermont, Burlington, Vermont, USA.'}, {'ForeName': 'Maura', 'Initials': 'M', 'LastName': 'Barry', 'Affiliation': 'Department of Medicine, Division of Hematology & Oncology, Larner College of Medicine at the University of Vermont, Burlington, Vermont, USA.'}, {'ForeName': 'Neil A', 'Initials': 'NA', 'LastName': 'Zakai', 'Affiliation': 'Department of Medicine, Division of Hematology & Oncology, Larner College of Medicine at the University of Vermont, Burlington, Vermont, USA.'}, {'ForeName': 'Diego Adrianzen', 'Initials': 'DA', 'LastName': 'Herrera', 'Affiliation': 'Department of Medicine, Division of Hematology & Oncology, Larner College of Medicine at the University of Vermont, Burlington, Vermont, USA.'}]",The oncologist,['10.1002/onco.13553']
3158,33017510,FDA Approval Summary: Olaparib Monotherapy or in Combination with Bevacizumab for the Maintenance Treatment of Patients with Advanced Ovarian Cancer.,"On December 19, 2018, the U.S. Food and Drug Administration (FDA) granted approval to olaparib monotherapy for first-line maintenance treatment of BRCA-mutated (BRCAm) advanced ovarian cancer and, on May 8, 2020, expanded the indication of olaparib to include its use in combination with bevacizumab for first-line maintenance treatment of homologous recombination deficient (HRD)-positive advanced ovarian cancer. Both these approvals were based on randomized, double-blind, placebo-controlled trials. Approval for olaparib monotherapy was based on the SOLO-1 trial, comparing the efficacy of olaparib versus placebo in patients with BRCAm advanced ovarian, fallopian tube, or primary peritoneal cancer after surgical cytoreduction and first-line platinum-based chemotherapy. Two companion diagnostic (CDx) tests were approved with this indication: BRACAnalysis CDx, for germline BRCA1/2 alterations, and FoundationOne CDx, for BRCA1/2 alterations in tissue specimens. Approval for olaparib in combination with bevacizumab was based on the results of the PAOLA-1 trial that compared olaparib with bevacizumab versus placebo plus bevacizumab in patients with advanced high-grade epithelial ovarian cancer, fallopian tube, or primary peritoneal cancer after first-line platinum-based chemotherapy and bevacizumab. Myriad myChoice CDx was designated as a companion diagnostic device for use of olaparib plus bevacizumab combination for ovarian cancer associated with HRD-positive status. Both trials demonstrated clinically meaningful improvements in progression-free survival and favorable benefit-risk profiles for the indicated populations. This article summarizes the FDA thought process and data supporting the approval of olaparib as monotherapy and in combination with bevacizumab for maintenance therapy in this setting. IMPLICATIONS FOR PRACTICE: These approvals represent the first poly (ADP-ribose) polymerase inhibitor, alone or in combination with bevacizumab, approved in first-line maintenance treatment of women with advanced ovarian cancer after cytoreductive surgery and chemotherapy. In patients with BRCA-mutated tumors, olaparib monotherapy demonstrated a 70% reduction in the risk of disease progression or death compared with placebo, and olaparib in combination with bevacizumab demonstrated a 67% reduction in the risk of disease progression or death compared with bevacizumab alone in homologous recombination deficient-positive tumors. These approvals represent a major advance for the treatment of women with advanced ovarian cancer who are in complete or partial response after their initial platinum-based chemotherapy.",2020,Both trials demonstrated clinically meaningful improvements in progression-free survival (PFS) and favorable benefit-risk profiles for the indicated populations.,"['women with advanced ovarian cancer following cytoreductive surgery and chemotherapy', 'homologous recombinant deficient (HRD)-positive advanced ovarian cancer', 'patients with advanced ovarian cancer', 'women with advanced ovarian cancer who are in complete or partial response following their initial platinum-based chemotherapy', 'patients with BRCAm advanced ovarian, fallopian tube, or primary peritoneal cancer following surgical cytoreduction and first-line platinum-based chemotherapy', 'patients with advanced high-grade epithelial ovarian cancer, fallopian tube, or primary peritoneal cancer following first-line platinum-based chemotherapy and']","['placebo plus bevacizumab', 'Olaparib monotherapy', 'bevacizumab', 'placebo', 'olaparib versus placebo', 'olaparib plus bevacizumab combination', 'PARP inhibitor, alone or in combination with bevacizumab']","['progression-free survival (PFS) and favorable benefit-risk profiles', 'risk of disease progression or death']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C3850079', 'cui_str': 'Cytoreductive surgery'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0599773', 'cui_str': 'Homologous Recombination'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0015560', 'cui_str': 'Fallopian tube structure'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0153467', 'cui_str': 'Malignant tumor of peritoneum'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C4721610', 'cui_str': 'Epithelial Ovarian Carcinoma'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C2316164', 'cui_str': 'olaparib'}, {'cui': 'C1882413', 'cui_str': 'Nicotinamide adenine dinucleotide adenosine diphosphate ribosyltransferase inhibitor-containing product'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0687742', 'cui_str': 'Risks and Benefits'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.108563,Both trials demonstrated clinically meaningful improvements in progression-free survival (PFS) and favorable benefit-risk profiles for the indicated populations.,"[{'ForeName': 'Shaily', 'Initials': 'S', 'LastName': 'Arora', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.'}, {'ForeName': 'Sanjeeve', 'Initials': 'S', 'LastName': 'Balasubramaniam', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Berman', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.'}, {'ForeName': 'Preeti', 'Initials': 'P', 'LastName': 'Narayan', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Suzman', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Bloomquist', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.'}, {'ForeName': 'Shenghui', 'Initials': 'S', 'LastName': 'Tang', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.'}, {'ForeName': 'Yutao', 'Initials': 'Y', 'LastName': 'Gong', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.'}, {'ForeName': 'Rajeshwari', 'Initials': 'R', 'LastName': 'Sridhara', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.'}, {'ForeName': 'Francisca Reyes', 'Initials': 'FR', 'LastName': 'Turcu', 'Affiliation': 'Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.'}, {'ForeName': 'Deb', 'Initials': 'D', 'LastName': 'Chatterjee', 'Affiliation': 'Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.'}, {'ForeName': 'Banu', 'Initials': 'B', 'LastName': 'Saritas-Yildirim', 'Affiliation': 'Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.'}, {'ForeName': 'Soma', 'Initials': 'S', 'LastName': 'Ghosh', 'Affiliation': 'Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.'}, {'ForeName': 'Reena', 'Initials': 'R', 'LastName': 'Philip', 'Affiliation': 'Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.'}, {'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Pathak', 'Affiliation': 'Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.'}, {'ForeName': 'Jennifer J', 'Initials': 'JJ', 'LastName': 'Gao', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.'}, {'ForeName': 'Laleh', 'Initials': 'L', 'LastName': 'Amiri-Kordestani', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Pazdur', 'Affiliation': 'Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.'}, {'ForeName': 'Julia A', 'Initials': 'JA', 'LastName': 'Beaver', 'Affiliation': 'Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.'}]",The oncologist,['10.1002/onco.13551']
3159,33021649,Association of Peer Comparison Emails With Electronic Health Record Documentation of Cancer Stage by Oncologists.,"Importance


Systematically capturing cancer stage is essential for any serious effort by health systems to monitor outcomes and quality of care in oncology. However, oncologists do not routinely record cancer stage in machine-readable structured fields in electronic health records (EHRs).
Objective


To evaluate whether a peer comparison email intervention that communicates an oncologist's performance on documenting cancer stage relative to that of peer physicians was associated with increased likelihood that stage was documented in the EHR.
Design, Setting, and Participants


This 12-month, randomized quality improvement pilot study aimed to increase oncologist staging documentation in the EHR. The pilot study was performed at Massachusetts General Hospital Cancer Center from October 1, 2018, to September 30, 2019. Participants included 56 oncologists across 3 practice sites who treated patients in the ambulatory setting and focused on diseases that use standardized staging systems. Data were analyzed from July 2, 2019, to March 5, 2020.
Interventions


Peer comparison intervention with as many as 3 emails to oncologists during 6 months that displayed the oncologist's staging documentation rate relative to all oncologists in the study sample.
Main Outcomes and Measures


The primary outcome was patient-level documentation of cancer stage, defined as the likelihood that a patient's stage of disease was documented in the EHR after the patient's first (eg, index) ambulatory visit during the pilot period.
Results


Among the 56 oncologists participating (32 men [57%]), receipt of emails with peer comparison data was associated with increased likelihood of documentation of cancer stage using the structured field in the EHR (23.2% vs 13.0% of patient index visits). In adjusted analyses, this difference represented an increase of 9.0 (95% CI, 4.4-13.5) percentage points (P = .002) in the probability that a patient's cancer stage was documented, a relative increase of 69% compared with oncologists who did not receive peer comparison emails. The association increased with each email that was sent, ranging from a nonsignificant 4.0 (95% CI, -0.8 to 8.8) percentage points (P = .09) after the first email to a statistically significant 11.2 (95% CI, 4.9-17.4) percentage points (P = .003) after the third email . The association was concentrated among an oncologist's new patients (increase of 11.8 [95% CI, 6.2-17.4] percentage points; P = .001) compared with established patients (increase of 1.6 [95% CI, -2.9 to 6.1] percentage points; P = .44) and persisted for 7 months after the email communications stopped.
Conclusions and Relevance


In a quality improvement pilot trial, peer comparison emails were associated with a substantial increase in oncologist use of the structured field in the EHR to document stage of disease.",2020,"In a quality improvement pilot trial, peer comparison emails were associated with a substantial increase in oncologist use of the structured field in the EHR to document stage of disease.","['Massachusetts General Hospital Cancer Center from October 1, 2018, to September 30, 2019', '56 oncologists participating (32 men [57', 'Participants included 56 oncologists across 3 practice sites who treated patients in the ambulatory setting and focused on diseases that use standardized staging systems']",['peer comparison email intervention'],"['likelihood of documentation of cancer stage', ""patient-level documentation of cancer stage, defined as the likelihood that a patient's stage of disease""]","[{'cui': 'C0024874', 'cui_str': 'Massachusetts'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0259990', 'cui_str': 'Oncologists'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0449394', 'cui_str': 'Staging system'}]","[{'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0175636', 'cui_str': 'Documentation procedure'}, {'cui': 'C0027646', 'cui_str': 'Cancer staging'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",,0.108324,"In a quality improvement pilot trial, peer comparison emails were associated with a substantial increase in oncologist use of the structured field in the EHR to document stage of disease.","[{'ForeName': 'Anna D', 'Initials': 'AD', 'LastName': 'Sinaiko', 'Affiliation': 'Department of Health Policy and Management, Harvard T. H. Chan School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Barnett', 'Affiliation': 'Department of Health Policy and Management, Harvard T. H. Chan School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Marema', 'Initials': 'M', 'LastName': 'Gaye', 'Affiliation': 'Department of Health Policy and Management, Harvard T. H. Chan School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Soriano', 'Affiliation': 'Patient Care Services, Massachusetts General Hospital, Boston.'}, {'ForeName': 'Therese', 'Initials': 'T', 'LastName': 'Mulvey', 'Affiliation': 'Division of Hematology and Oncology, Department of Medicine, General Hospital Cancer Center and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Ephraim', 'Initials': 'E', 'LastName': 'Hochberg', 'Affiliation': 'Division of Hematology and Oncology, Department of Medicine, General Hospital Cancer Center and Harvard Medical School, Boston, Massachusetts.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.15935']
3160,33026143,"Design and baseline characteristics of the AMPLITUDE-O cardiovascular outcomes trial of efpeglenatide, a weekly glucagon-like peptide-1 receptor agonist.","AIM


The effect of the weekly exendin-based glucagon-like peptide-1 receptor agonist efpeglenatide on cardiovascular (CV) outcomes in high-risk patients with type 2 diabetes (T2DM) with and without chronic kidney disease (CKD) is unknown.
MATERIALS AND METHODS


People with T2DM and glycated haemoglobin >7%, ≥18 years old with previous CV disease, or ≥50 years old with CKD [defined as an estimated glomerular filtration rate (eGFR) of 25-59.9 mL/min/1.73 m 2  ], and one or more additional CV risk factors were recruited. Participants were randomized in a 1:1:1 ratio, stratified by current, intended or neither current nor intended use of a sodium-glucose cotransporter-2 (SGLT2) inhibitor to receive weekly injections of efpeglenatide (4 mg or 6 mg) or masked placebo. The primary outcome is a major adverse CV event defined as non-fatal myocardial infarction, non-fatal stroke or CV death. Secondary outcomes include a composite kidney outcome (new onset macroalbuminuria with an increase from baseline of ≥30%, sustained 40% decrease in eGFR, renal replacement therapy, or sustained eGFR <15 mL/min/1.73 m 2  ). The trial will continue until ≥330 participants have had a major adverse CV event outcome and the sample size was based on accruing enough outcomes to detect non-inferiority of efpeglenatide versus placebo.
RESULTS


Recruitment of 4076 participants (33% women, mean age 64.5 years) occurred between 11 May 2018 and 25 April 2019 at 344 sites in 28 countries. Mean baseline glycated haemoglobin was 8.9% (1.5), 31.6% had an eGFR <60 mL/min/1.73 m 2  , 89.5% had previous CV disease and 15.0% were on an SGLT2 inhibitor.
CONCLUSIONS


The results of the AMPLITUDE O trial will inform the use of exendin-based glucagon-like peptide-1 receptor agonist to people with T2DM and high CV risk, with and without CKD, in the presence and absence of an SGLT2 inhibitor.",2020,"Mean baseline HbA1c was 8.9% (1.5), 31.6% had an eGFR <60 ml/min/1.73m 2  , 89.5% had previous CV disease, and 15.0% were on an SGLT2 inhibitor.
","['18\u2009years old with prior CV disease, or ≥\u200950\u2009years old with CKD (defined as an estimated glomerular filtration rate [eGFR] of 25 -59.9 ml/min/1.73m 2  ) and ≥ one additional CV risk factor were recruited', '330 participants have had a MACE outcome and the sample size', 'People with T2DM and HbA1c >7%, ≥', 'high risk patients with type 2 diabetes (T2DM) with and without chronic kidney disease (CKD', '4,076 participants (33% women, mean age 64.5\u2009years) occurred between May 11, 2018 and April 25, 2019 at 344 sites in 28 countries']","['placebo', 'Efpeglenatide, a Weekly GLP-1 RA', 'sodium-glucose cotransporter-2 (SGLT2) inhibitor to receive weekly injections of efpeglenatide (4 mg or 6 mg) or masked placebo', 'exendin-based glucagon-like peptide-1 receptor agonist (GLP1-RA) efpeglenatide']","['major adverse CV event (MACE) defined as either non-fatal myocardial infarction, non-fatal stroke, or CV death', 'Mean baseline HbA1c', 'cardiovascular (CV) outcomes', 'composite kidney outcome (new onset macroalbuminuria with an increase from baseline of ≥\u200930% , sustained 40% decrease in eGFR, renal replacement therapy, or sustained eGFR']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C4517719', 'cui_str': '330'}, {'cui': 'C0286421', 'cui_str': 'ACE protocol 2'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0454664', 'cui_str': 'Country'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C1654921', 'cui_str': 'Macroalbuminuria'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}]",4076.0,0.370767,"Mean baseline HbA1c was 8.9% (1.5), 31.6% had an eGFR <60 ml/min/1.73m 2  , 89.5% had previous CV disease, and 15.0% were on an SGLT2 inhibitor.
","[{'ForeName': 'Hertzel C', 'Initials': 'HC', 'LastName': 'Gerstein', 'Affiliation': 'Population Health Research Institute, Hamilton Health Sciences, Hamilton, Ontario, Canada.'}, {'ForeName': 'Kelley', 'Initials': 'K', 'LastName': 'Branch', 'Affiliation': 'Division of Cardiology, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Heenan', 'Affiliation': 'Population Health Research Institute, Hamilton Health Sciences, Hamilton, Ontario, Canada.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Del Prato', 'Affiliation': 'Department of Clinical & Experimental Medicine, Section of Metabolic Diseases and Diabetes, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Nardev S', 'Initials': 'NS', 'LastName': 'Khurmi', 'Affiliation': 'Sanofi, Bridgewater, New Jersey, USA.'}, {'ForeName': 'Carolyn S P', 'Initials': 'CSP', 'LastName': 'Lam', 'Affiliation': 'National Heart Centre Singapore and Duke-National University of Singapore, Singapore.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Pratley', 'Affiliation': 'AdventHealth Translational Research Institute, Orlando, Florida, USA.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Rosenstock', 'Affiliation': 'Dallas Diabetes Research Center at Medical City, Dallas, Texas, USA.'}, {'ForeName': 'Naveed', 'Initials': 'N', 'LastName': 'Sattar', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14223']
3161,33026449,Icotinib With Concurrent Radiotherapy vs Radiotherapy Alone in Older Adults With Unresectable Esophageal Squamous Cell Carcinoma: A Phase II Randomized Clinical Trial.,"Importance


Palliative radiotherapy (RT) is generally recommended for older patients with esophageal squamous cell carcinoma (ESCC) with poor prognosis. A new combination treatment is therefore needed.
Objective


To assess the efficacy and toxicity of RT plus icotinib vs RT alone in older patients with ESCC.
Design, Setting, and Participants


This randomized, multicenter, open-label, phase II clinical trial was conducted in China, with enrollment between January 1, 2015, and October 31, 2016. Patients aged 70 years or older with clinical stage T2 to T4, N0/1, M0/1a unresectable (because of comorbidities, T4 disease, unresectable lymph node, or refused surgery) ESCC were randomized 1:1 to receive RT plus icotinib or RT alone. Radiation was prescribed at 60 Gy in 30 fractions in both groups, and icotinib was administered at a dosage of 125 mg 3 times a day in the RT plus icotinib group. The last follow-up was completed on June 30, 2019, and data were analyzed from July 1 to September 30, 2019.
Interventions


Patients were randomized to either RT plus icotinib or RT alone.
Main Outcomes and Measures


The primary end point was overall survival (OS). Treatment-related toxic effects were evaluated. Immunohistochemistry was performed to analyze epidermal growth factor receptor (EGFR) expression if available.
Results


A total of 127 patients (median age, 76 years [range, 70-91 years]; 76 men [59.8%]) were enrolled and were eligible for survival analysis. Median OS was 24.0 (95% CI, 22.2-25.8) months in the RT plus icotinib group vs 16.3 (95% CI, 13.8-18.8) months in the RT group (hazard ratio, 0.53; 95% CI, 0.33-0.87; P = .008). No difference was observed in grades 3 or 4 adverse events. Patients with EGFR overexpression had a significantly better median overall survival (not reached vs 16.3 months [range, 2.6-45.1 months]; P = .03) in the RT plus icotinib group.
Conclusions and Relevance


In this randomized clinical trial, icotinib plus RT was well tolerated and improved OS in older patients with ESCC relative to RT alone. Patients with EGFR overexpression benefitted more from icotinib with RT.
Trial Registration


ClinicalTrials.gov Identifier: NCT02375581.",2020,"Patients with EGFR overexpression had a significantly better median overall survival (not reached vs 16.3 months [range, 2.6-45.1 months]; P = .03) in the RT plus icotinib group.
","['China, with enrollment between January 1, 2015, and October 31, 2016', '127 patients (median age, 76 years [range, 70-91 years]; 76 men [59.8%]) were enrolled and were eligible for survival analysis', 'older patients with ESCC', 'Patients with EGFR overexpression benefitted more from icotinib with RT', 'Older Adults With Unresectable Esophageal Squamous Cell Carcinoma', 'older patients with esophageal squamous cell carcinoma (ESCC) with poor prognosis', 'Patients aged 70 years or older with clinical stage T2 to T4, N0/1, M0/1a unresectable (because of comorbidities, T4 disease, unresectable lymph node, or refused surgery', 'older patients with ESCC relative to RT alone']","['RT plus icotinib vs RT alone', 'icotinib plus RT', 'RT plus icotinib or RT alone', 'Palliative radiotherapy (RT', 'Icotinib With Concurrent Radiotherapy vs Radiotherapy']","['epidermal growth factor receptor (EGFR) expression', 'overall survival (OS', 'tolerated and improved OS', 'grades 3 or 4 adverse events', 'efficacy and toxicity', 'median overall survival', 'Median OS', 'toxic effects']","[{'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0038953', 'cui_str': 'Analysis, Survival'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0279626', 'cui_str': 'Squamous cell carcinoma of esophagus'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C2604307', 'cui_str': 'icotinib'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0278252', 'cui_str': 'Prognosis bad'}, {'cui': 'C0205563', 'cui_str': 'Clinical stage finding'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}, {'cui': 'C0017095', 'cui_str': 'Trash'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2604307', 'cui_str': 'icotinib'}, {'cui': 'C0587605', 'cui_str': 'Palliative care service'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}]","[{'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",127.0,0.12861,"Patients with EGFR overexpression had a significantly better median overall survival (not reached vs 16.3 months [range, 2.6-45.1 months]; P = .03) in the RT plus icotinib group.
","[{'ForeName': 'Honglei', 'Initials': 'H', 'LastName': 'Luo', 'Affiliation': ""Department of Radiation Oncology, the Affiliated Huaian No.1 People's Hospital of Nanjing Medical University, Huaian, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Jiang', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital & Shenzhen Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Shenzhen, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Ma', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital & Shenzhen Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Shenzhen, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Chen', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital & Shenzhen Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Shenzhen, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Fang', 'Affiliation': ""Department of Radiation Oncology, Zhejiang Provincial People's Hospital, People's Hospital of Hangzhou Medical College, Hangzhou, Zhejiang, China.""}, {'ForeName': 'Lingyu', 'Initials': 'L', 'LastName': 'Ding', 'Affiliation': 'Department of Medical Oncology, Hangzhou Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Yuhui', 'Initials': 'Y', 'LastName': 'Hua', 'Affiliation': 'Department of Pharmacy, Hangzhou Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Dexi', 'Initials': 'D', 'LastName': 'Du', 'Affiliation': 'Department of Radiation Oncology, Lishui Central Hospital, Lishui, China.'}, {'ForeName': 'Zhao', 'Initials': 'Z', 'LastName': 'Jing', 'Affiliation': 'Department of Radiation Oncology, Hangzhou Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Ruifei', 'Initials': 'R', 'LastName': 'Xie', 'Affiliation': 'Department of Bio-informatics, Hangzhou Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Yaqi', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': ""Department of Radiation Oncology, the Affiliated Huaian No.1 People's Hospital of Nanjing Medical University, Huaian, China.""}, {'ForeName': 'Jiayang', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Department of Radiation Oncology, the Affiliated Huaian No.1 People's Hospital of Nanjing Medical University, Huaian, China.""}, {'ForeName': 'Rongjing', 'Initials': 'R', 'LastName': 'Zhou', 'Affiliation': 'Department of Pathology, Hangzhou Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Zhifeng', 'Initials': 'Z', 'LastName': 'Tian', 'Affiliation': 'Department of Radiation Oncology, Lishui Central Hospital, Lishui, China.'}, {'ForeName': 'Shixiu', 'Initials': 'S', 'LastName': 'Wu', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital & Shenzhen Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Shenzhen, China.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.19440']
3162,33026175,Intranasal insulin administration decreases cerebral blood flow in cortico-limbic regions: A neuropharmacological imaging study in normal and overweight males.,"AIM


To assess and compare the effects of 160 IU intranasal insulin (IN-INS) administration on regional cerebral blood flow (rCBF) in healthy male individuals with normal weight and overweight phenotypes.
METHODS


Thirty young male participants (mean age 25.9 years) were recruited and stratified into two cohorts based on body mass index: normal weight (18.5-24.9 kg/m 2  ) and overweight (25.0-29.9 kg/m 2  ). On separate mornings participants received 160 IU of IN-INS using an intranasal protocol and intranasal placebo as part of a double-blind crossover design. Thirty minutes following administration rCBF data were collected using a magnetic resonance imaging method called pseudocontinuous arterial spin labelling. Blood samples were collected to assess insulin sensitivity and changes over time in peripheral glucose, insulin and C-peptide.
RESULTS


Insulin sensitivity did not significantly differ between groups. Compared with placebo, IN-INS administration reduced rCBF in parts of the hippocampus, insula, putamen, parahippocampal gyrus and fusiform gyrus in the overweight group. No effect was seen in the normal weight group. Insula rCBF was greater in the overweight group versus normal weight only under placebo conditions. Peripheral glucose and insulin levels were not affected by IN-INS. C-peptide levels in the normal weight group decreased significantly over time following IN-INS administration but not placebo.
CONCLUSION


Insulin-induced changes within key regions of the brain involved in gustation, memory and reward were observed in overweight healthy male individuals. Following placebo administration, differences in gustatory rCBF were observed between overweight and normal weight healthy individuals.",2020,"When compared to placebo, IN-INS administration reduced rCBF in parts of the hippocampus, insula, putamen, parahippocampal gyrus and fusiform gyrus, in the overweight group only.","['normal and overweight males', 'cortico-limbic regions', 'healthy male individuals with normal weight and overweight phenotypes', 'overweight healthy male individuals', 'Thirty young male volunteers (mean age 25.9\u2009years) were recruited and stratified into two cohorts based on body mass index; normal weight (18.5-24.9\u2009kg/m 2  ) and overweight (25.0-29.9\u2009kg/m 2  ']","['intranasal protocol and intranasal placebo', 'placebo', 'Intranasal insulin', '160\u2009IU intranasal insulin (IN-INS']","['regional cerebral blood flow (rCBF', 'insulin sensitivity and changes over time in peripheral glucose, insulin and C-peptide', 'cerebral blood flow', 'Peripheral glucose and insulin levels', 'C-peptide levels', 'Insulin sensitivity', 'Insula rCBF', 'gustatory regional CBF']","[{'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C2712185', 'cui_str': 'Normal weight'}, {'cui': 'C0031437', 'cui_str': 'Phenotype'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517611', 'cui_str': '18.5'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C4319554', 'cui_str': '160'}]","[{'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0006558', 'cui_str': 'C-peptide'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement'}, {'cui': 'C0202100', 'cui_str': 'Insulin C-peptide measurement'}, {'cui': 'C0021640', 'cui_str': 'Insular structure'}, {'cui': 'C0439678', 'cui_str': 'Gustatory'}]",30.0,0.385553,"When compared to placebo, IN-INS administration reduced rCBF in parts of the hippocampus, insula, putamen, parahippocampal gyrus and fusiform gyrus, in the overweight group only.","[{'ForeName': 'Jed O', 'Initials': 'JO', 'LastName': 'Wingrove', 'Affiliation': ""Centre for Neuroimaging Sciences, King's College London, London, UK.""}, {'ForeName': 'Owen', 'Initials': 'O', 'LastName': ""O'Daly"", 'Affiliation': ""Centre for Neuroimaging Sciences, King's College London, London, UK.""}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Forbes', 'Affiliation': ""Institute of Pharmaceutical Science, King's College London, London, UK.""}, {'ForeName': 'Magda', 'Initials': 'M', 'LastName': 'Swedrowska', 'Affiliation': ""Institute of Pharmaceutical Science, King's College London, London, UK.""}, {'ForeName': 'Stephanie A', 'Initials': 'SA', 'LastName': 'Amiel', 'Affiliation': ""Diabetes Research Group, King's College Hospital Campus, Weston Education Central, King's College London, London, UK.""}, {'ForeName': 'Fernando O', 'Initials': 'FO', 'LastName': 'Zelaya', 'Affiliation': ""Centre for Neuroimaging Sciences, King's College London, London, UK.""}]","Diabetes, obesity & metabolism",['10.1111/dom.14213']
3163,33026544,Xenograft for anterior cruciate ligament reconstruction was associated with high graft processing infection.,"PURPOSE


To evaluate clinical ad radiological outcomes of anterior cruciate ligament (ACL) reconstruction with an immunochemically modified porcine patellar tendon xenograft controlled against human Achilles tendon allograft at 24-month minimum follow-up.
METHODS


66 patients undergoing arthroscopic ACL reconstruction were randomized into 2 groups: 34 allografts and 32 xenografts treated to attenuate the host immune response. Follow-up was 24-month minimum. Anterior knee stability was measured as KT - 1000 side-to-side laxity difference (respect to the contralateral healthy knee). Functional performance was assessed by one-legged hop test. Objective manual pivot-shift test and subjective (IKDC, Tegner and SF-36) outcomes were collected. MRI and standard X-Ray were performed.
RESULTS


61 subjects (32 allograft, 29 xenograft) were evaluated at 12 and 24 months. Six of the subjects in xenograft group (20.6%) got an infection attributed to a water-based pathogen graft contamination in processing. Intention-to-treat analysis (using the last observation carried forward imputation method) revealed higher KT - 1000 laxity in xenograft group at 24-month follow-up (P = .042). Also pivot-shift was higher in xenograft group at 12-month (P = .015) and 24-month follow-up (P = .038). Per-protocol analysis (missing/contaminated subjects excluded) did not revealed clinical differences between groups. Tibial tunnel widening in the allograft group was low, whereas xenograft tunnel widening was within the expected range of 20-35% as reported in the literature. No immunological reactivity was associated to xenograft group.
CONCLUSIONS


High infection rate (20.6%) was reported in xenograft group. Both groups of patients achieved comparable clinical outcomes if missing/contaminated subjects are excluded. Improved harvesting/processing treatments in future studies using xenografts for ACL reconstruction are needed to reduce infection rate, otherwise xenograft should not be used in ACL reconstruction.
LEVEL OF EVIDENCE


Multicenter and double-blinded Randomized Controlled Clinical Trial, Level I.",2020,Also pivot-shift was higher in xenograft group at 12-month (P = .015) and 24-month follow-up (P = .038).,"['66 patients undergoing arthroscopic ACL reconstruction', '61 subjects (32 allograft, 29 xenograft']",['anterior cruciate ligament (ACL) reconstruction with an immunochemically modified porcine patellar tendon xenograft controlled against human Achilles tendon allograft'],"['xenograft tunnel widening', 'immunological reactivity', 'Anterior knee stability', 'Tibial tunnel widening', 'Objective manual pivot-shift test and subjective (IKDC, Tegner and SF-36) outcomes', 'Functional performance']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C0040739', 'cui_str': 'Allogeneic transplantation'}, {'cui': 'C0520484', 'cui_str': 'Xenogeneic transplantation'}]","[{'cui': 'C0078960', 'cui_str': 'Structure of anterior cruciate ligament of knee joint'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0039005', 'cui_str': 'Suidae'}, {'cui': 'C0206332', 'cui_str': 'Structure of patellar ligament'}, {'cui': 'C0520484', 'cui_str': 'Xenogeneic transplantation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0001074', 'cui_str': 'Structure of Achilles tendon'}, {'cui': 'C0040739', 'cui_str': 'Allogeneic transplantation'}]","[{'cui': 'C0520484', 'cui_str': 'Xenogeneic transplantation'}, {'cui': 'C0337138', 'cui_str': 'Tunnel'}, {'cui': 'C0205470', 'cui_str': 'Immunologic'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C3669378', 'cui_str': 'Pivot shift test'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]",66.0,0.030646,Also pivot-shift was higher in xenograft group at 12-month (P = .015) and 24-month follow-up (P = .038).,"[{'ForeName': 'Willem', 'Initials': 'W', 'LastName': 'Van Der Merwe', 'Affiliation': 'Sport Science Institute of S. Africa, Cape Town, South Africa.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Lind', 'Affiliation': 'Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Faunø', 'Affiliation': 'Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Kees', 'Initials': 'K', 'LastName': 'Van Egmond', 'Affiliation': 'Dept. of Orthopaedic Surgery, Isala Klinieken, Zwolle, Netherlands.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Zaffagnini', 'Affiliation': 'IRCCS Istituto Ortopedici Rizzoli, University of Bologna, Lab. Biomeccanica - Via di Barbiano, 1/10, 40137, Bologna, Italy.'}, {'ForeName': 'Maurilio', 'Initials': 'M', 'LastName': 'Marcacci', 'Affiliation': 'IRCCS Humanitas University, Milano / former Istituto Ortopedici Rizzoli, University of Bologna, II Clinica Ortopedica, Bologna, Italy.'}, {'ForeName': 'Ramon', 'Initials': 'R', 'LastName': 'Cugat', 'Affiliation': 'Hospital Quiron, Artoscopia GC, Barcelona, Spain.'}, {'ForeName': 'Rene', 'Initials': 'R', 'LastName': 'Verdonk', 'Affiliation': 'Dept. of Orthopaedic Surgery & Traumatology, Gent Univ. Hospital, Ghent, Belgium.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Ibañez', 'Affiliation': 'Clinica Cemtro, Orthopaedic Surgery & Traumatology, Madrid, Spain.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Guillen', 'Affiliation': 'Clinica Cemtro, Orthopaedic Surgery & Traumatology, Madrid, Spain.'}, {'ForeName': 'Giulio Maria', 'Initials': 'GM', 'LastName': 'Marcheggiani Muccioli', 'Affiliation': 'IRCCS Istituto Ortopedici Rizzoli, University of Bologna, Lab. Biomeccanica - Via di Barbiano, 1/10, 40137, Bologna, Italy. marcheggianimuccioli@me.com.'}]",Journal of experimental orthopaedics,['10.1186/s40634-020-00292-0']
3164,33022096,Quality-adjusted survival with first-line cabozantinib or sunitinib for advanced renal cell carcinoma in the CABOSUN randomized clinical trial (Alliance).,"BACKGROUND


CABOSUN was a randomized, open-label, phase 2 trial evaluating first-line cabozantinib versus sunitinib in patients with advanced renal cell carcinoma (aRCC). This post hoc analysis evaluated quality-adjusted survival using Quality-adjusted Time Without Symptoms of disease or Toxicity of treatment (Q-TWiST).
METHODS


Survival plots for cabozantinib and sunitinib (650-day follow-up) were partitioned into 3 health states: time spent before disease progression without toxicity (TWiST; toxicity based on National Cancer Institute Common Terminology Criteria for Adverse Events [version 4.0] grade 3/4 adverse events), time spent before disease progression with toxicity (TOX; durations of adverse events based on published literature), and time after disease recurrence (relapse) or progression to death (REL). Q-TWiST was the sum of the mean time spent in each state, with each state weighted to reflect patient preferences (from 0 [worst] to 1 [best]) using utility scores. TWiST was always weighted as 1. Overall survival and time to disease progression were based on all randomized patients (157 patients); TOX was based on all randomized and treated patients (150 patients).
RESULTS


Across all utility combinations tested, Q-TWiST was found to be longer with cabozantinib versus sunitinib (range of differences, +24 days to +137 days). Q-TWiST differences that were found to be statistically significant (+92 days [95% confidence interval, 5-178 days] to +137 days [95% confidence interval, 60-214 days]) were of a clinically meaningful effect size (≥80 days), and were based on utility values that included those considered relevant for patients with aRCC (REL utility weight of 0.355, TOX utility weight of 0-1, and TWiST utility weight of 1).
CONCLUSIONS


In patients with aRCC, first-line cabozantinib was found to provide longer quality-adjusted survival compared with sunitinib. These findings may help to inform clinical decision making.
LAY SUMMARY


Cabozantinib and sunitinib are drugs that are used to treat patients with advanced kidney cancer. Clinical trials have shown that cabozantinib offers benefits over sunitinib, giving patients more time before their cancer progresses. It is important that this additional time before disease progression does not come at the expense of patients' quality of life, which can be affected by treatment side effects and/or ongoing cancer symptoms. Both quantity and quality of life are central to optimal treatment. In the current analysis of patients with advanced kidney cancer who were initiating treatment for the first time, cabozantinib provided more quality time before cancer progression compared with sunitinib.",2020,"In patients with aRCC, first-line cabozantinib was found to provide longer quality-adjusted survival compared with sunitinib.","['patients with advanced renal cell carcinoma (aRCC', 'advanced renal cell carcinoma', 'patients with advanced kidney cancer']","['first-line cabozantinib or sunitinib', 'TWiST', 'line cabozantinib versus sunitinib']","['Quality-adjusted survival', 'Overall survival and time to disease progression', 'quantity and quality of life', 'quality time before cancer progression', 'toxicity (TWiST; toxicity based on National Cancer Institute Common Terminology Criteria for Adverse Events [version 4.0] grade 3/4 adverse events), time spent before disease progression with toxicity (TOX; durations of adverse events based on published literature), and time after disease recurrence (relapse) or progression to death (REL']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007134', 'cui_str': 'Renal cell carcinoma'}, {'cui': 'C0740457', 'cui_str': 'Malignant tumor of kidney'}]","[{'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C3181682', 'cui_str': 'cabozantinib'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C0040480', 'cui_str': 'Torsion'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0178874', 'cui_str': 'Tumor progression'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0040480', 'cui_str': 'Torsion'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1516728', 'cui_str': 'National Cancer Institute common terminology criteria for adverse events'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0034037', 'cui_str': 'Publishing'}, {'cui': 'C0023866', 'cui_str': 'Literature'}, {'cui': 'C0679254', 'cui_str': 'Disease recurrence'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0035018', 'cui_str': 'rel Oncogene'}]",,0.11722,"In patients with aRCC, first-line cabozantinib was found to provide longer quality-adjusted survival compared with sunitinib.","[{'ForeName': 'Ronald C', 'Initials': 'RC', 'LastName': 'Chen', 'Affiliation': 'Department of Radiation Oncology, University of Kansas Cancer Center, Kansas City, Kansas.'}, {'ForeName': 'Toni K', 'Initials': 'TK', 'LastName': 'Choueiri', 'Affiliation': ""Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute/Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Feuilly', 'Affiliation': 'Department of Oncology, Ipsen Pharma SAS, Boulogne-Billancourt Cedex, France.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Meng', 'Affiliation': 'Analytica Laser, Lörrach, Germany.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Lister', 'Affiliation': 'Analytica Laser, Lörrach, Germany.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Marteau', 'Affiliation': 'Department of Oncology, Ipsen Pharma SAS, Boulogne-Billancourt Cedex, France.'}, {'ForeName': 'Aaron D', 'Initials': 'AD', 'LastName': 'Falchook', 'Affiliation': 'Department of Radiation Oncology, Memorial Cancer Institute, Pembroke Pines, Florida.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Morris', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'George', 'Affiliation': 'Department of Radiation Oncology, University of Kansas Cancer Center, Kansas City, Kansas.'}, {'ForeName': 'Darren R', 'Initials': 'DR', 'LastName': 'Feldman', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.'}]",Cancer,['10.1002/cncr.33169']
3165,33022318,Treating tobacco dependence to aid re-employment among job-seekers: A randomized controlled trial.,"INTRODUCTION


U.S. reductions in smoking have not been experienced equally. Smoking prevalence is greater among persons of lower education, lower income, and unemployed. We evaluated whether a cessation intervention for job-seekers would result in significantly fewer cigarettes smoked per day and a greater likelihood of tobacco abstinence and re-employment, compared to the control condition at 6-months follow-up.
METHODS


Unemployed, job-seekers who smoked daily were recruited from five employment development departments in the San Francisco Bay Area, October 2015 to February 2018. Intention to quit smoking was not required. Participants were randomized to a brief motivationally-tailored, computer-assisted counseling intervention or referred to a toll-free quitline. Midstudy, 8-weeks of combination nicotine replacement was added to the intervention. Expired carbon monoxide and cotinine testing verified abstinence. Data were analyzed fall 2019.
RESULTS


Participants (N = 360; 70% men; 43% African American, 27% non-Hispanic Caucasian; 19% unhoused) averaged 12 cigarettes/day (SD = 6), 67% smoked within 30 min of wakening; 27% were in preparation stage to quit. During the 6-month study period, intervention participants were more likely to make a quit attempt (71% vs. 58%, p = .021) and reported significantly greater reduction in cigarettes/day than control participants (median reduction: 6.9 vs. 5.0, p = .038); however, bioconfirmed abstinence (3%) and re-employment (36%) did not differ by treatment group.
CONCLUSIONS


In a diverse sample with economic hardships, quit attempts and smoking reduction were greater in the intervention group; however, few achieved abstinence, and neither abstinence nor re-employment differed by condition. A priority group, further research is needed on smoking and re-employment.",2020,"In a diverse sample with economic hardships, quit attempts and smoking reduction were greater in the intervention group; however, few achieved abstinence, and neither abstinence nor re-employment differed by condition.","['Participants (N\u202f=\u202f360; 70% men; 43% African American, 27% non-Hispanic Caucasian', 'job-seekers', 'Unemployed, job-seekers who smoked daily were recruited from five employment development departments in the San Francisco Bay Area, October 2015 to February 2018']","['nicotine replacement', 'brief motivationally-tailored, computer-assisted counseling intervention or referred to a toll-free quitline']","['bioconfirmed abstinence', 'quit attempt', 'quit attempts and smoking reduction']","[{'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0028811', 'cui_str': 'Occupation'}, {'cui': 'C0041674', 'cui_str': 'Unemployed'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0036152', 'cui_str': 'San Francisco'}, {'cui': 'C3203003', 'cui_str': 'Bays'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C1321919', 'cui_str': 'TLR4 protein, human'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]","[{'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C4505208', 'cui_str': 'Smoking Reduction'}]",,0.0440133,"In a diverse sample with economic hardships, quit attempts and smoking reduction were greater in the intervention group; however, few achieved abstinence, and neither abstinence nor re-employment differed by condition.","[{'ForeName': 'Judith J', 'Initials': 'JJ', 'LastName': 'Prochaska', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University, Stanford, CA, United States of America. Electronic address: jpro@stanford.edu.'}, {'ForeName': 'Cati', 'Initials': 'C', 'LastName': 'Brown-Johnson', 'Affiliation': 'Evaluation Sciences Unit, Division of Primary Care and Population Health, Department of Medicine, Stanford University, Stanford, CA, United States of America.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Baiocchi', 'Affiliation': 'Department of Epidemiology and Population Health, Stanford University, Stanford, CA, United States of America.'}, {'ForeName': 'Adrienne S', 'Initials': 'AS', 'LastName': 'Lazaro', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University, Stanford, CA, United States of America.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Chieng', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University, Stanford, CA, United States of America.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Stinson', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University, Stanford, CA, United States of America.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Anzai', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University, Stanford, CA, United States of America.'}]",Preventive medicine,['10.1016/j.ypmed.2020.106259']
3166,33022324,Fit and Strong! Plus: Twelve and eighteen month follow-up results for a comparative effectiveness trial among overweight/obese older adults with osteoarthritis.,"This comparative effectiveness trial compared the longer-term effectiveness (12 and 18 months) of the standard Fit & Strong! physical activity program to Fit & Strong! Plus, which combined physical activity and dietary weight loss. Outcomes were weight, diet quality, physical activity, osteoarthritis symptoms, performance measures, and anxiety/depression. In this study, 413 overweight/obese participants with OA, ≥60 years old and primarily African American, were randomly assigned to Fit & Strong! (F&S!) or Fit & Strong! Plus (F&S! Plus), with outcomes assessed at 2, 6, 12, and 18 months. 356 (86%) participants completed the 18-month visit. Compared with participants randomized to standard F&S!, F&S! Plus participants maintained longer-term benefits at 12 months in weight (mean change ± SE: -1.7 ± 0.3 kg for F&S! Plus vs -0.9 ± 0.3 kg for F&S!, p = 0.049), BMI (-0.6 ± 0.1 vs -0.3 ± 0.1 kg/m 2 , p = 0.04), waist circumference (-2.7 ± 0.6 vs -0.4 ± 0.6 cm, p = 0.004), and lower extremity strength (1.6 ± 0.2 vs 1.0 ± 0.2 chair stands, p = 0.046). At 18 months, F&S! Plus participants showed improved lower extremity strength (1.4 ± 0.2 vs. 0.7 ± 0.2 chair stands, p = 0.045. African American older adults in the F&S! Plus arm showed sustained modest improvements in weight, waist circumference, and lower extremity strength at 12 months and in lower extremity strength at 18 months compared to F&S!. Implications for the translation of evidence-based programs into community settings to support healthy behaviors in older adults are discussed.",2020,"Plus arm showed sustained modest improvements in weight, waist circumference, and lower extremity strength at 12 months and in lower extremity strength at 18 months compared to F&S!. Implications for the translation of evidence-based programs into community settings to support healthy behaviors in older adults are discussed.","['356 (86%) participants completed the 18-month visit', 'African American older adults in the F&S', '413 overweight/obese participants with OA, ≥60\u202fyears old and primarily African American', 'overweight/obese older adults with osteoarthritis']","['Plus (F&S', 'Fit & Strong', 'physical activity program to Fit & Strong', 'standard Fit & Strong', 'standard F&S!, F&S', 'F&S']","['BMI', 'weight, waist circumference, and lower extremity strength', 'weight, diet quality, physical activity, osteoarthritis symptoms, performance measures, and anxiety/depression', 'waist circumference', 'lower extremity strength']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0442821', 'cui_str': 'Strong'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",413.0,0.0535567,"Plus arm showed sustained modest improvements in weight, waist circumference, and lower extremity strength at 12 months and in lower extremity strength at 18 months compared to F&S!. Implications for the translation of evidence-based programs into community settings to support healthy behaviors in older adults are discussed.","[{'ForeName': 'Marian L', 'Initials': 'ML', 'LastName': 'Fitzgibbon', 'Affiliation': 'Institute for Health Research and Policy, School of Public Health, University of Illinois at Chicago, 1747 West Roosevelt Road, Chicago, IL 60608, United States of America; University of Illinois Cancer Center, 818 South Wolcott Avenue, Chicago, IL 60612, United States of America; Department of Pediatrics, University of Illinois at Chicago, 840 South Wood Street, Chicago, IL 60612, United States of America. Electronic address: mlf@uic.edu.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Tussing-Humphreys', 'Affiliation': 'Institute for Health Research and Policy, School of Public Health, University of Illinois at Chicago, 1747 West Roosevelt Road, Chicago, IL 60608, United States of America; University of Illinois Cancer Center, 818 South Wolcott Avenue, Chicago, IL 60612, United States of America; Department of Medicine, University of Illinois at Chicago, 808 South Wood Street, Chicago, IL 60612, United States of America.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Schiffer', 'Affiliation': 'Institute for Health Research and Policy, School of Public Health, University of Illinois at Chicago, 1747 West Roosevelt Road, Chicago, IL 60608, United States of America.'}, {'ForeName': 'Renae', 'Initials': 'R', 'LastName': 'Smith-Ray', 'Affiliation': 'Institute for Health Research and Policy, School of Public Health, University of Illinois at Chicago, 1747 West Roosevelt Road, Chicago, IL 60608, United States of America; Health Analytics, Research and Reporting, Walgreen Co., 102 Wilmot Road, Deerfield, IL 60015, United States of America.'}, {'ForeName': 'David X', 'Initials': 'DX', 'LastName': 'Marquez', 'Affiliation': 'Institute for Health Research and Policy, School of Public Health, University of Illinois at Chicago, 1747 West Roosevelt Road, Chicago, IL 60608, United States of America; Center for Research on Health and Aging, University of Illinois at Chicago, 1747 West Roosevelt Road, Chicago, IL 60608, United States of America; Department of Kinesiology and Nutrition, University of Illinois at Chicago, 1919 West Taylor Street, Chicago, IL 60612, United States of America.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'DeMott', 'Affiliation': 'Institute for Health Research and Policy, School of Public Health, University of Illinois at Chicago, 1747 West Roosevelt Road, Chicago, IL 60608, United States of America; Center for Research on Health and Aging, University of Illinois at Chicago, 1747 West Roosevelt Road, Chicago, IL 60608, United States of America.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Berbaum', 'Affiliation': 'Institute for Health Research and Policy, School of Public Health, University of Illinois at Chicago, 1747 West Roosevelt Road, Chicago, IL 60608, United States of America.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Hughes', 'Affiliation': 'Institute for Health Research and Policy, School of Public Health, University of Illinois at Chicago, 1747 West Roosevelt Road, Chicago, IL 60608, United States of America; Center for Research on Health and Aging, University of Illinois at Chicago, 1747 West Roosevelt Road, Chicago, IL 60608, United States of America; Division of Community Health Sciences, University of Illinois at Chicago, 1603 West Taylor Street, IL 60612, United States of America.'}]",Preventive medicine,['10.1016/j.ypmed.2020.106267']
3167,33022345,Effects of tDCS on neuroplasticity and inflammatory biomarkers in bipolar depression: Results from a sham-controlled study.,"OBJECTIVES


We investigated the role of peripheral biomarkers associated with neuroplasticity and immune-inflammatory processes on the effects of transcranial direct current stimulation (tDCS), a safe, affordable, and portable non-invasive neuromodulatory treatment, in bipolar depression.
METHODS


This is an exploratory analysis using a dataset from the sham-controlled study the Bipolar Depression Electrical Treatment Trial (BETTER)(clinicaltrials.govNCT02152878). Participants were 52 adults with type I or II bipolar disorder in a moderate-to-severe depressive episode, randomized to 12 bifrontal active or sham tDCS sessions over a 6-week treatment course. Plasma levels of brain derived neurotrophic factor (BDNF), glial cell derived neurotrophic factor (GDNF), interleukins (IL) 2, 4, 6, 8, 10, 18, 33, 1β, 12p70, 17a, interferon gamma (IFN), tumor necrosis factor alpha (TNF) and its soluble receptors 1 and 2, ST2, and KLOTHO were investigated at baseline and endpoint. We performed analyses unadjusted for multiple testing to evaluate whether baseline biomarkers were predictive for depression improvement and changed during treatment using linear regression models.
RESULTS


A time x group interaction (Cohen's d: -1.16, 95% CI = -1.96 to -0.3, p = .005) was found for IL-8, with greater reductions after active tDCS. Higher baseline IL-6 plasma levels was associated with symptomatic improvement after tDCS (F (1,43)  = 5.43; p = .025). Other associations were not significant.
CONCLUSIONS


Our exploratory findings suggested that IL-6 is a potential predictor of tDCS response and IL-8 might decrease after tDCS; although confirmatory studies are warranted due to the multiplicity of comparisons.",2020,"Plasma levels of brain derived neurotrophic factor (BDNF), glial cell derived neurotrophic factor (GDNF), interleukins (IL) 2, 4, 6, 8, 10, 18, 33, 1β, 12p70, 17a, interferon gamma (IFN), tumor necrosis factor alpha (TNF) and its soluble receptors 1 and 2, ST2, and KLOTHO were investigated at baseline and endpoint.","['bipolar depression', 'Participants were 52 adults with type I or II bipolar disorder in a moderate-to-severe depressive episode']","['12 bifrontal active or sham tDCS sessions', 'transcranial direct current stimulation (tDCS', 'tDCS']","['Plasma levels of brain derived neurotrophic factor (BDNF), glial cell derived neurotrophic factor (GDNF), interleukins (IL) 2, 4, 6, 8, 10, 18, 33, 1β, 12p70, 17a, interferon gamma (IFN), tumor necrosis factor alpha (TNF) and its soluble receptors 1 and 2, ST2', 'neuroplasticity and inflammatory biomarkers', 'Higher baseline IL-6 plasma levels']","[{'cui': 'C0005587', 'cui_str': 'Bipolar affective disorder, current episode depression'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0349217', 'cui_str': 'Depressive episode, unspecified'}]","[{'cui': 'C0445448', 'cui_str': 'Bifrontal'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0027836', 'cui_str': 'Glia'}, {'cui': 'C0027754', 'cui_str': 'Nerve growth factor'}, {'cui': 'C0021756', 'cui_str': 'Interleukin-2'}, {'cui': 'C0021745', 'cui_str': 'Interferon Type II'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0450499', 'cui_str': 'ST2'}, {'cui': 'C0027880', 'cui_str': 'Plasticity, Neuronal'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}]",52.0,0.250759,"Plasma levels of brain derived neurotrophic factor (BDNF), glial cell derived neurotrophic factor (GDNF), interleukins (IL) 2, 4, 6, 8, 10, 18, 33, 1β, 12p70, 17a, interferon gamma (IFN), tumor necrosis factor alpha (TNF) and its soluble receptors 1 and 2, ST2, and KLOTHO were investigated at baseline and endpoint.","[{'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Goerigk', 'Affiliation': 'Department of Psychological Methodology and Assessment, Ludwig-Maximilians-University, Munich, Germany; Department of Psychiatry and Psychotherapy, Ludwig-Maximilians-Universität, Nußbaumstraße 7, 80336 Munich, Germany; Hochschule Fresenius, University of Applied Sciences, Munich, Germany.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Cretaz', 'Affiliation': 'ECT Service, Department and Institute of Psychiatry, Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil; Bipolar Disorder Research Program, Department and Institute of Psychiatry, Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Bernardo', 'Initials': 'B', 'LastName': 'Sampaio-Junior', 'Affiliation': 'Private practice, São Paulo, Brazil.'}, {'ForeName': 'Érica Leandro Marciano', 'Initials': 'ÉLM', 'LastName': 'Vieira', 'Affiliation': 'Interdisciplinary Laboratory of Medical Investigation, Faculdade de Medicina, Universidade Federal de Minas Gerais, Minas Gerais, Brazil; Centre for Addiction and Mental Healthy (CAMH), Toronto, ON, Canada.'}, {'ForeName': 'Wagner', 'Initials': 'W', 'LastName': 'Gattaz', 'Affiliation': 'Laboratory of Neurosciences (LIM-27), Instituto Nacional de Biomarcadores em Neuropsiquiatria (INBioN), Department and Institute of Psychiatry, Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Izio', 'Initials': 'I', 'LastName': 'Klein', 'Affiliation': 'Laboratory of Neurosciences (LIM-27), Instituto Nacional de Biomarcadores em Neuropsiquiatria (INBioN), Department and Institute of Psychiatry, Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Beny', 'Initials': 'B', 'LastName': 'Lafer', 'Affiliation': 'Bipolar Disorder Research Program, Department and Institute of Psychiatry, Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Antônio Lúcio', 'Initials': 'AL', 'LastName': 'Teixeira', 'Affiliation': 'Interdisciplinary Laboratory of Medical Investigation, Faculdade de Medicina, Universidade Federal de Minas Gerais, Minas Gerais, Brazil; Neuropsychiatry Program, Department of Psychiatry and Behavioral Science, UT Health, Houston, United States of America.'}, {'ForeName': 'André F', 'Initials': 'AF', 'LastName': 'Carvalho', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine, University of Toronto, Toronto, ON, Canada; Centre for Addiction and Mental Healthy (CAMH), Toronto, ON, Canada.'}, {'ForeName': 'Paulo A', 'Initials': 'PA', 'LastName': 'Lotufo', 'Affiliation': 'Department of Internal Medicine, Faculdade de Medicina da Universidade de São Paulo & Hospital Universitário, Universidade de São Paulo, Av. Prof Lineu Prestes 2565, 05508-000 São Paulo, Brazil.'}, {'ForeName': 'Isabela M', 'Initials': 'IM', 'LastName': 'Benseñor', 'Affiliation': 'Department of Internal Medicine, Faculdade de Medicina da Universidade de São Paulo & Hospital Universitário, Universidade de São Paulo, Av. Prof Lineu Prestes 2565, 05508-000 São Paulo, Brazil.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Bühner', 'Affiliation': 'Department of Psychological Methodology and Assessment, Ludwig-Maximilians-University, Munich, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Padberg', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Ludwig-Maximilians-Universität, Nußbaumstraße 7, 80336 Munich, Germany.'}, {'ForeName': 'André R', 'Initials': 'AR', 'LastName': 'Brunoni', 'Affiliation': 'Laboratory of Neurosciences (LIM-27), Instituto Nacional de Biomarcadores em Neuropsiquiatria (INBioN), Department and Institute of Psychiatry, Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil; Department of Internal Medicine, Faculdade de Medicina da Universidade de São Paulo & Hospital Universitário, Universidade de São Paulo, Av. Prof Lineu Prestes 2565, 05508-000 São Paulo, Brazil. Electronic address: brunoni@usp.br.'}]",Progress in neuro-psychopharmacology & biological psychiatry,['10.1016/j.pnpbp.2020.110119']
3168,33023357,Clinical efficacy and safety of secukinumab in patients with psoriasis and comorbidities: pooled analysis of 4 phase 3 clinical trials.,"BACKGROUND


The influence of comorbidities on the efficacy and safety of biologic therapies in psoriasis has not been rigorously explored.
OBJECTIVE


To assess the incremental burden of comorbidities on clinical efficacy and safety of secukinumab vs. etanercept and placebo among patients with plaque psoriasis pooled from 4 phase 3 trials.
METHODS


Efficacy was assessed at week 12 according to achievement of Psoriasis Area and Severity Index (PASI) and Investigator's Global Assessment (IGA; modified 2011) responses. Efficacy comparisons between treatment arms stratified by comorbidity status were made using logistic regression analysis with nonresponder imputation. Relationships between baseline characteristics and clinical responses were evaluated by  χ   2  tests.
RESULTS


Of 2401 patients, 1469 (61.2%) had ≥1 active baseline comorbidity. Regardless of comorbidity status, patients receiving secukinumab were more likely to achieve PASI and IGA responses than those receiving etanercept or placebo at week 12 ( p  < .05 for all comparisons). Body weight of ≥90 kg was consistently associated with a decreased likelihood of achieving PASI and IGA responses ( p  < .01 for all comparisons). Safety was comparable across treatment arms stratified by comorbidity.
CONCLUSIONS


Secukinumab improved clinical outcomes and was well tolerated in patients with concomitant baseline comorbid conditions.",2020,Body weight of ≥90 kg was consistently associated with a decreased likelihood of achieving PASI and IGA responses ( P  < .01 for all comparisons).,"['patients with psoriasis and comorbidities', 'patients with plaque psoriasis pooled from 4 phase 3 trials', 'patients with concomitant baseline comorbid conditions', '2401 patients, 1469 (61.2%) had ≥1 active baseline comorbidity']","['secukinumab vs etanercept and placebo', 'placebo', 'secukinumab']","['Safety', 'likelihood of achieving PASI and IGA responses', ""Psoriasis Area and Severity Index (PASI) and Investigator's Global Assessment (IGA; modified 2011) responses"", 'PASI and IGA responses', 'Body weight', 'Clinical efficacy and safety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0406317', 'cui_str': 'Chronic small plaque psoriasis'}, {'cui': 'C0337051', 'cui_str': 'Pool'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1275743', 'cui_str': 'Co-morbid conditions'}, {'cui': 'C4517833', 'cui_str': '61.2'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C3179547', 'cui_str': 'secukinumab'}, {'cui': 'C0717758', 'cui_str': 'Etanercept'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}]",2401.0,0.135151,Body weight of ≥90 kg was consistently associated with a decreased likelihood of achieving PASI and IGA responses ( P  < .01 for all comparisons).,"[{'ForeName': 'Alice B', 'Initials': 'AB', 'LastName': 'Gottlieb', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Jashin J', 'Initials': 'JJ', 'LastName': 'Wu', 'Affiliation': 'Dermatology Research and Education Foundation, Irvine, CA, USA.'}, {'ForeName': 'Christopher E M', 'Initials': 'CEM', 'LastName': 'Griffiths', 'Affiliation': 'Dermatology Centre, Salford Royal NHS Foundation Trust, NIHR Manchester Biomedical Research Centre, The University of Manchester, Manchester, UK.'}, {'ForeName': 'Kwaku', 'Initials': 'K', 'LastName': 'Marfo', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Muscianisi', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Xiangyi', 'Initials': 'X', 'LastName': 'Meng', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Frueh', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Lebwohl', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}]",The Journal of dermatological treatment,['10.1080/09546634.2020.1832187']
3169,33024120,Gut microbiome-related effects of berberine and probiotics on type 2 diabetes (the PREMOTE study).,"Human gut microbiome is a promising target for managing type 2 diabetes (T2D). Measures altering gut microbiota like oral intake of probiotics or berberine (BBR), a bacteriostatic agent, merit metabolic homoeostasis. We hence conducted a randomized, double-blind, placebo-controlled trial with newly diagnosed T2D patients from 20 centres in China. Four-hundred-nine eligible participants were enroled, randomly assigned (1:1:1:1) and completed a 12-week treatment of either BBR-alone, probiotics+BBR, probiotics-alone, or placebo, after a one-week run-in of gentamycin pretreatment. The changes in glycated haemoglobin, as the primary outcome, in the probiotics+BBR (least-squares mean [95% CI], -1.04[-1.19, -0.89]%) and BBR-alone group (-0.99[-1.16, -0.83]%) were significantly greater than that in the placebo and probiotics-alone groups (-0.59[-0.75, -0.44]%, -0.53[-0.68, -0.37]%, P < 0.001). BBR treatment induced more gastrointestinal side effects. Further metagenomics and metabolomic studies found that the hypoglycaemic effect of BBR is mediated by the inhibition of DCA biotransformation by Ruminococcus bromii. Therefore, our study reports a human microbial related mechanism underlying the antidiabetic effect of BBR on T2D. (Clinicaltrial.gov Identifier: NCT02861261).",2020,BBR treatment induced more gastrointestinal side effects.,"['Four-hundred-nine eligible participants', 'newly diagnosed T2D patients from 20 centres in China']","['BBR-alone, probiotics+BBR, probiotics-alone, or placebo', 'berberine and probiotics', 'placebo', 'BBR']","['gut microbiota like oral intake of probiotics or berberine (BBR), a bacteriostatic agent, merit metabolic homoeostasis', 'gastrointestinal side effects', 'glycated haemoglobin']","[{'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0005117', 'cui_str': 'Berberine'}]","[{'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0005117', 'cui_str': 'Berberine'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}]",409.0,0.295139,BBR treatment induced more gastrointestinal side effects.,"[{'ForeName': 'Yifei', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'National Clinical Research Centre for Metabolic Diseases, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200025, China.'}, {'ForeName': 'Yanyun', 'Initials': 'Y', 'LastName': 'Gu', 'Affiliation': 'National Clinical Research Centre for Metabolic Diseases, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200025, China.'}, {'ForeName': 'Huahui', 'Initials': 'H', 'LastName': 'Ren', 'Affiliation': 'BGI-Shenzhen, Shenzhen, 518083, China.'}, {'ForeName': 'Shujie', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'National Clinical Research Centre for Metabolic Diseases, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200025, China.'}, {'ForeName': 'Huanzi', 'Initials': 'H', 'LastName': 'Zhong', 'Affiliation': 'BGI-Shenzhen, Shenzhen, 518083, China.'}, {'ForeName': 'Xinjie', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Dalian Institute of Chemical Physics, Chinese Academy of Science, Dalian, Liaoning Province, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Xuejiang', 'Initials': 'X', 'LastName': 'Gu', 'Affiliation': 'The First Affiliated hospital of Wenzhou Medical University, Zhejiang Province, China.'}, {'ForeName': 'Yaoming', 'Initials': 'Y', 'LastName': 'Xue', 'Affiliation': 'Nanfang Hospital, Southern Medical University, Guangdong Province, China.'}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Huang', 'Affiliation': 'Tong Ren Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Jialin', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Central Hospital of Minhang District, Shanghai, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Qilu Hospital of Shandong University, Shandong Province, China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': 'Fujian Provincial Hospital, Fujian Province, China.'}, {'ForeName': 'Shen', 'Initials': 'S', 'LastName': 'Qu', 'Affiliation': ""Shanghai Tenth People's Hospital of Tong Ji University, Shanghai, China.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Liang', 'Affiliation': 'Xuzhou Central Hospital, Jiangsu Province, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Qin', 'Affiliation': 'Xin Hua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Huang', 'Affiliation': 'Chang Hai Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Yongde', 'Initials': 'Y', 'LastName': 'Peng', 'Affiliation': ""Shanghai First People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Dalian Institute of Chemical Physics, Chinese Academy of Science, Dalian, Liaoning Province, China.'}, {'ForeName': 'Xiaolin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Dalian Institute of Chemical Physics, Chinese Academy of Science, Dalian, Liaoning Province, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Kong', 'Affiliation': 'BGI-Shenzhen, Shenzhen, 518083, China.'}, {'ForeName': 'Guixue', 'Initials': 'G', 'LastName': 'Hou', 'Affiliation': 'BGI-Shenzhen, Shenzhen, 518083, China.'}, {'ForeName': 'Mengyu', 'Initials': 'M', 'LastName': 'Gao', 'Affiliation': 'BGI-Shenzhen, Shenzhen, 518083, China.'}, {'ForeName': 'Zhun', 'Initials': 'Z', 'LastName': 'Shi', 'Affiliation': 'BGI-Shenzhen, Shenzhen, 518083, China.'}, {'ForeName': 'Xuelin', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'National Clinical Research Centre for Metabolic Diseases, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200025, China.'}, {'ForeName': 'Yixuan', 'Initials': 'Y', 'LastName': 'Qiu', 'Affiliation': 'National Clinical Research Centre for Metabolic Diseases, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200025, China.'}, {'ForeName': 'Yuanqiang', 'Initials': 'Y', 'LastName': 'Zou', 'Affiliation': 'BGI-Shenzhen, Shenzhen, 518083, China.'}, {'ForeName': 'Huanming', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'BGI-Shenzhen, Shenzhen, 518083, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'BGI-Shenzhen, Shenzhen, 518083, China.'}, {'ForeName': 'Guowang', 'Initials': 'G', 'LastName': 'Xu', 'Affiliation': 'Dalian Institute of Chemical Physics, Chinese Academy of Science, Dalian, Liaoning Province, China.'}, {'ForeName': 'Shenghan', 'Initials': 'S', 'LastName': 'Lai', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Junhua', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'BGI-Shenzhen, Shenzhen, 518083, China. lijunhua@genomics.cn.'}, {'ForeName': 'Guang', 'Initials': 'G', 'LastName': 'Ning', 'Affiliation': 'National Clinical Research Centre for Metabolic Diseases, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200025, China.'}, {'ForeName': 'Weiqing', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'National Clinical Research Centre for Metabolic Diseases, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200025, China. wqingw61@163.com.'}]",Nature communications,['10.1038/s41467-020-18414-8']
3170,33024123,Metastable hybridization-based DNA information storage to allow rapid and permanent erasure.,"The potential of DNA as an information storage medium is rapidly growing due to advances in DNA synthesis and sequencing. However, the chemical stability of DNA challenges the complete erasure of information encoded in DNA sequences. Here, we encode information in a DNA information solution, a mixture of true message- and false message-encoded oligonucleotides, and enables rapid and permanent erasure of information. True messages are differentiated by their hybridization to a ""truth marker"" oligonucleotide, and only true messages can be read; binding of the truth marker can be effectively randomized even with a brief exposure to the elevated temperature. We show 8 separate bitmap images can be stably encoded and read after storage at 25 °C for 65 days with an average of over 99% correct information recall, which extrapolates to a half-life of over 15 years at 25 °C. Heating to 95 °C for 5 minutes, however, permanently erases the message.",2020,"We show 8 separate bitmap images can be stably encoded and read after storage at 25 °C for 65 days with an average of over 99% correct information recall, which extrapolates to a half-life of over 15 years at 25 °C.",[],[],[],[],[],[],,0.0718338,"We show 8 separate bitmap images can be stably encoded and read after storage at 25 °C for 65 days with an average of over 99% correct information recall, which extrapolates to a half-life of over 15 years at 25 °C.","[{'ForeName': 'Jangwon', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Department of Bioengineering, Rice University, Houston, TX, 77030, USA.'}, {'ForeName': 'Jin H', 'Initials': 'JH', 'LastName': 'Bae', 'Affiliation': 'Department of Bioengineering, Rice University, Houston, TX, 77030, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Baym', 'Affiliation': 'Department of Biomedical Informatics, Harvard Medical School, Boston, MA, 02115, USA.'}, {'ForeName': 'David Yu', 'Initials': 'DY', 'LastName': 'Zhang', 'Affiliation': 'Department of Bioengineering, Rice University, Houston, TX, 77030, USA. dyz1@rice.edu.'}]",Nature communications,['10.1038/s41467-020-18842-6']
3171,33030354,"Treatment satisfaction, safety, and effectiveness of biosimilar insulin glargine is comparable in patients with type 2 diabetes mellitus after switching from insulin glargine or insulin degludec: a post-marketing safety study.","OBJECTIVE


To evaluate insulin treatment satisfaction, safety, and effectiveness of biosimilar insulin glargine (GLY) in real-world clinical practice for Japanese patients with type 2 diabetes mellitus (T2DM) who switched from originator insulin glargine (100 U/mL) or insulin degludec treatment to GLY treatment.
METHODS


The Insulin Treatment Satisfaction Questionnaire (ITSQ) was used to assess treatment satisfaction in a subgroup analysis of a post-marketing safety study. Hypoglycemia incidence rates and blood glucose control are also reported during the 12-month observation period for GLY-switched patients.
RESULTS


Of 1104 patients with T2DM enrolled to participate, 565 patients switched from either insulin glargine U100/mL ( n  = 470) or insulin degludec ( n  = 95) to GLY. The mean total change from baseline to 3 months for total ITSQ score was 1.35 (95% confidence interval [CI] - 0.13 to 2.83,  p  = .073) for patients who switched from insulin glargine and 2.63 (95% CI -1.43 to 6.70,  p  = .195) for patients who switched from insulin degludec to GLY treatment. The mean change from baseline to 12 months in hypoglycemia events reported per month was -0.04% (95% CI -0.12 to 0.03,  p  = .236) for patients who switched from insulin glargine and no change for patients who switched from insulin degludec (0.00, 95% CI -0.20 to 0.20,  p  = 1.000). Non-significant mean changes from baseline to 12 months were observed for hemoglobin A1c and fasting plasma glucose in GLY-switched patients.
CONCLUSIONS


Treatment satisfaction does not change significantly in Japanese patients with T2DM who switch to GLY from the reference product or from insulin degludec. Safety and effectiveness over a 12-month period were similar in GLY-treated patients who switched from either insulin glargine or insulin degludec.
CLINICALTRIALS.GOV


Not applicable.",2020,Non-significant mean changes from baseline to 12 months were observed for hemoglobin A1c and fasting plasma glucose in GLY-switched patients.,"['Japanese patients with type 2 diabetes mellitus (T2DM) who switched from', 'Japanese patients with T2DM who switch to GLY from the reference product or from insulin degludec', '1104 patients with T2DM enrolled to participate', '565 patients switched from either', '100\u2009U/mL) or insulin degludec treatment to GLY treatment', 'patients with type 2 diabetes mellitus after switching from insulin glargine or insulin degludec']","['insulin glargine or insulin degludec', 'biosimilar insulin glargine (GLY', 'originator insulin glargine', 'insulin glargine', 'insulin glargine U100/mL (n\u2009=\u2009470) or insulin degludec (n\u2009=\u200995) to GLY', 'biosimilar insulin glargine']","['hypoglycemia events', 'hemoglobin A1c and fasting plasma glucose', 'Hypoglycemia incidence rates and blood glucose control', 'Treatment satisfaction, safety, and effectiveness', 'total ITSQ score', 'mean total change', 'Insulin Treatment Satisfaction Questionnaire (ITSQ', 'Safety and effectiveness']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0017890', 'cui_str': 'Glycine'}, {'cui': 'C3491971', 'cui_str': 'insulin degludec'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439340', 'cui_str': 'kU/L'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}]","[{'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C3491971', 'cui_str': 'insulin degludec'}, {'cui': 'C4045974', 'cui_str': 'Biosimilars'}, {'cui': 'C0017890', 'cui_str': 'Glycine'}]","[{'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",1104.0,0.0389723,Non-significant mean changes from baseline to 12 months were observed for hemoglobin A1c and fasting plasma glucose in GLY-switched patients.,"[{'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Taki', 'Affiliation': 'Medicines Development Unit-Japan, Eli Lilly Japan K. K, Kobe, Japan.'}, {'ForeName': 'Momoha', 'Initials': 'M', 'LastName': 'Koyanagi', 'Affiliation': 'Medicines Development Unit-Japan, Eli Lilly Japan K. K, Kobe, Japan.'}, {'ForeName': 'Soshi', 'Initials': 'S', 'LastName': 'Nagaoka', 'Affiliation': 'Medicines Development Unit-Japan, Eli Lilly Japan K. K, Kobe, Japan.'}, {'ForeName': 'Tomotaka', 'Initials': 'T', 'LastName': 'Shingaki', 'Affiliation': 'Medicines Development Unit-Japan, Eli Lilly Japan K. K, Kobe, Japan.'}]",Current medical research and opinion,['10.1080/03007995.2020.1834374']
3172,33026771,IncobotulinumtoxinA Demonstrates Safety and Prolonged Duration of Effect in a Dose-Ranging Study for Glabellar Lines.,"BACKGROUND


Recently reported clinical data provides evidence that increasing the dose of botulinum toxin A increases the duration of efficacy. A 2-stage Phase 2, randomized, double-blind study investigated the duration of effect and safety of IncobotulinumtoxinA (INCO; Xeomin&reg;, Bocouture&reg;; Merz Pharmaceuticals GmbH, Frankfurt am Main, Germany) at doses higher than the approved 20 units (U) for glabellar frown lines (GFL). Primary safety and efficacy endpoints of Stage 1 are reported here.
METHODS


151 subjects with moderate-to-severe GFL were randomized 1:2:2 to receive a single treatment with 20U, 50U, or 75U INCO. The primary efficacy endpoint was median duration of at least 1-point improvement from baseline as assessed by investigator at maximum frown on the Facial Wrinkle Scale.
RESULTS


The median duration of effect was 185 days for the 50U dose group (95% CI:[182, 205]) and 210 days for the 75U dose group (95% CI:[182, 217]). Duration of effect was significantly longer for 75U vs 50U (P=0.0400) and 20U (P=0.0166) despite the study not being powered for confirmatory statistical significance testing between the dose groups. Duration of effect was also longer for 50U vs 20U, however; statistical significance was not reached (P=0.4349). The incidence of treatment-related adverse events was low across all doses (20U:2[6.7%], 50U:6[10.0%] and 75U:8[13.1%]).
CONCLUSIONS


These results demonstrate a dose effect of at least 6 months duration with higher doses in the majority of GFL subjects. All doses were well tolerated and safety was consistent with the known safety profile of 20U INCO for GFL. J Drugs Dermatol. 2020;19(10):985-991. doi:10.36849/JDD.2020.5454.",2020,Duration of effect was significantly longer for 75U vs 50U (P=0.0400) and 20U (P=0.0166) despite the study not being powered for confirmatory statistical significance testing between the dose groups.,"['151 subjects with moderate-to-severe GFL', 'Glabellar Lines']","['botulinum toxin', 'IncobotulinumtoxinA (INCO', 'IncobotulinumtoxinA']","['incidence of treatment-related adverse events', 'Duration of effect', 'duration of efficacy', 'median duration of effect', 'tolerated and safety', 'median duration of at least 1-point improvement from baseline as assessed by investigator at maximum frown on the Facial Wrinkle Scale']","[{'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0948887', 'cui_str': 'Glabellar frown lines'}, {'cui': 'C0442019', 'cui_str': 'Glabellar'}, {'cui': 'C0205132', 'cui_str': 'Linear'}]","[{'cui': 'C0006055', 'cui_str': 'botulinum toxin'}, {'cui': 'C2930113', 'cui_str': 'IncobotulinumtoxinA'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0037301', 'cui_str': 'Wrinkled skin'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",151.0,0.100046,Duration of effect was significantly longer for 75U vs 50U (P=0.0400) and 20U (P=0.0166) despite the study not being powered for confirmatory statistical significance testing between the dose groups.,"[{'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Kerscher', 'Affiliation': ''}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Fabi', 'Affiliation': ''}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Fischer', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Gold', 'Affiliation': ''}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Joseph', 'Affiliation': ''}, {'ForeName': 'Welf', 'Initials': 'W', 'LastName': 'Prager', 'Affiliation': ''}, {'ForeName': 'Berthold', 'Initials': 'B', 'LastName': 'Rzany', 'Affiliation': ''}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Yoelin', 'Affiliation': ''}, {'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Roll', 'Affiliation': ''}, {'ForeName': 'Gudrun', 'Initials': 'G', 'LastName': 'Klein', 'Affiliation': ''}, {'ForeName': 'Corey', 'Initials': 'C', 'LastName': 'Maas', 'Affiliation': ''}]",Journal of drugs in dermatology : JDD,['10.36849/JDD.2020.5454']
3173,33028102,"Randomized, placebo-controlled trial of xyloglucan and gelose for the treatment of acute diarrhea in children.","BACKGROUND


Oral rehydration is the main treatment of acute diarrhea in children. This study was undertaken to evaluate the efficacy and safety of xyloglucan and gelose (agar-agar) plus oral rehydration solution (ORS) compared with placebo and ORS for reduction of acute diarrhea symptoms in children.
METHODS


In a randomized, double-blind, placebo-controlled trial, children with acute gastroenteritis received xyloglucan/gelose plus ORS (n = 50) or placebo plus ORS (n = 50) for 5 days. Demographic, clinical, anthropometric and laboratory parameters were recorded and analyzed.
RESULTS


Xyloglucan/gelose plus ORS reduced the total number of type 7 and 6 stools on the Bristol Stool Form scale ( p  = 0.040 and  p  = 0.015, respectively, compared to placebo plus ORS), and had a rapid onset of action, evident 6 hours post-treatment. Xyloglucan/gelose plus ORS also improved associated clinical symptoms (apathy, vomiting, flatulence, and blood in stool). compared with placebo plus ORS. Except for a generalized rash of unknown causality in a patient receiving placebo plus ORS, all other adverse events (dehydration, n = 7, cough, n = 1, exacerbation of vomiting, n = 1) were deemed unrelated to study medication.
CONCLUSIONS


Xyloglucan/gelose plus ORS was effective and safe in treating acute diarrhea in children.",2020,"RESULTS


Xyloglucan/gelose plus ORS reduced the total number of type 7 and 6 stools on the Bristol Stool Form scale ( p  = 0.040 and  p  = 0.015, respectively, compared to placebo plus ORS), and had a rapid onset of action, evident 6 hours post-treatment.","['children', 'children with acute gastroenteritis received', 'acute diarrhea in children', 'n = 50) or']","['placebo plus ORS', 'placebo and ORS', 'xyloglucan/gelose plus ORS', 'placebo', 'xyloglucan and gelose (agar-agar) plus oral rehydration solution (ORS', 'xyloglucan', 'Xyloglucan/gelose plus ORS']","['clinical symptoms (apathy, vomiting, flatulence, and blood in stool', 'efficacy and safety', 'total number of type 7 and 6 stools on the Bristol Stool Form scale', 'acute diarrhea symptoms']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0267446', 'cui_str': 'Acute gastroenteritis'}, {'cui': 'C0740441', 'cui_str': 'Acute diarrhea'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0078516', 'cui_str': 'World Health Organization oral rehydration solution'}, {'cui': 'C0078641', 'cui_str': 'xyloglucan'}, {'cui': 'C0001771', 'cui_str': 'Agar'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0085632', 'cui_str': 'Indifference'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0018932', 'cui_str': 'Hematochezia'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C1997606', 'cui_str': 'Bristol stool form scale'}, {'cui': 'C0740441', 'cui_str': 'Acute diarrhea'}]",1.0,0.693173,"RESULTS


Xyloglucan/gelose plus ORS reduced the total number of type 7 and 6 stools on the Bristol Stool Form scale ( p  = 0.040 and  p  = 0.015, respectively, compared to placebo plus ORS), and had a rapid onset of action, evident 6 hours post-treatment.","[{'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Santos', 'Affiliation': ""Vall d'Hebron Institut de Recerca (VHIR) , Barcelona, Spain.""}, {'ForeName': 'Virgil', 'Initials': 'V', 'LastName': 'Musta', 'Affiliation': 'Victor Babes University of Medicine and Pharmacy , Timisoara.'}, {'ForeName': 'Catalina Mihaela', 'Initials': 'CM', 'LastName': 'Luca', 'Affiliation': 'Grigore T Popa University of Medicine and Pharmacy , Iasi, Romania.'}, {'ForeName': 'Oana Andreea', 'Initials': 'OA', 'LastName': 'Belei', 'Affiliation': 'First Pediatric Clinic, Victor Babes University of Medicine and Pharmacy , Timisoara, Romania.'}, {'ForeName': 'Simona Claudia', 'Initials': 'SC', 'LastName': 'Cambrea', 'Affiliation': 'Faculty of Medicine, Ovidius University , Constanta, Romania.'}]",Expert review of gastroenterology & hepatology,['10.1080/17474124.2021.1833715']
3174,33028550,Trial Of Neurostimulation In Conversion Symptoms (TONICS): a feasibility randomised controlled trial of transcranial magnetic stimulation for functional limb weakness.,"OBJECTIVES


Transcranial magnetic stimulation (TMS) has been used therapeutically for functional (conversion) motor symptoms but there is limited evidence for its efficacy and the optimal protocol. We examined the feasibility of a novel randomised controlled trial (RCT) protocol of TMS to treat functional limb weakness.
DESIGN


A double-blind (patient, outcome assessor) two parallel-arm, controlled RCT.
SETTING


Specialist neurology and neuropsychiatry services at a large National Health Service Foundation Trust in London, UK.
PARTICIPANTS


Patients with a diagnosis of functional limb weakness (Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition). Exclusion criteria included comorbid neurological or major psychiatric disorder, contraindications to TMS or previous TMS treatment.
INTERVENTIONS


Patients were randomised to receive either active (single-pulse TMS to primary motor cortex (M1) above resting motor threshold) or inactive treatment (single-pulse TMS to M1 below resting motor threshold). Both groups received two TMS sessions, 4 weeks apart.
OUTCOME MEASURES


We assessed recruitment, randomisation and retention rates. The primary outcome was patient-rated symptom change (Clinical Global Impression-Improvement scale, CGI-I). Secondary outcomes included clinician-rated symptom change, psychosocial functioning and disability. Outcomes were assessed at baseline, both TMS visits and at 3-month follow-up.
RESULTS


Twenty-two patients were recruited and 21 (96%) were successfully randomised (active=10; inactive=11). Nineteen (91%) patients were included at follow-up (active=9; inactive=10). Completion rates for most outcomes were good (80%-100%). Most patients were satisfied/very satisfied with the trial in both groups, although ratings were higher in the inactive arm (active=60%, inactive=92%). Adverse events were not more common for the active treatment. Treatment effect sizes for patient-rated CGI-I scores were small-moderate (Cliff's delta=-0.1-0.3, CIs-0.79 to 0.28), reflecting a more positive outcome for the active treatment (67% and 44% of active arm-rated symptoms as 'much improved' at session 2 and follow-up, respectively, vs 20% inactive group). Effect sizes for secondary outcomes were variable.
CONCLUSIONS


Our protocol is feasible. The findings suggest that supramotor threshold TMS of M1 is safe, acceptable and potentially beneficial as a treatment for functional limb weakness. A larger RCT is warranted.
TRIAL REGISTRATION NUMBER


ISRCTN51225587.",2020,"Most patients were satisfied/very satisfied with the trial in both groups, although ratings were higher in the inactive arm (active=60%, inactive=92%).","['functional limb weakness', 'Specialist neurology and neuropsychiatry services at a large National Health Service Foundation Trust in London, UK', 'Patients with a diagnosis of functional limb weakness (Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition', 'Exclusion criteria included comorbid neurological or major psychiatric disorder, contraindications to TMS or previous TMS treatment', 'Twenty-two patients were recruited and 21 (96']","['TMS', 'active (single-pulse TMS to primary motor cortex (M1) above resting motor threshold) or inactive treatment (single-pulse TMS to M1 below resting motor threshold', 'Transcranial magnetic stimulation (TMS', 'transcranial magnetic stimulation', 'Neurostimulation']","['patient-rated symptom change (Clinical Global Impression-Improvement scale, CGI-I', 'Adverse events', 'Completion rates', 'clinician-rated symptom change, psychosocial functioning and disability']","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0587246', 'cui_str': 'Muscle weakness of limb'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0870956', 'cui_str': 'Neuropsychiatry'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0027462', 'cui_str': 'National Health Services'}, {'cui': 'C0016617', 'cui_str': 'Foundations'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1136324', 'cui_str': 'Diagnostic and Statistical Manual of Mental Disorders'}, {'cui': 'C0205439', 'cui_str': 'Fifth'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4284772', 'cui_str': '22'}]","[{'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C1564622', 'cui_str': 'Transcranial Magnetic Stimulation, Single Pulse'}, {'cui': 'C3495441', 'cui_str': 'Precentral Motor Cortex'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0521307', 'cui_str': 'Neurostimulation procedure'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0231170', 'cui_str': 'Disability'}]",22.0,0.502793,"Most patients were satisfied/very satisfied with the trial in both groups, although ratings were higher in the inactive arm (active=60%, inactive=92%).","[{'ForeName': 'Susannah', 'Initials': 'S', 'LastName': 'Pick', 'Affiliation': ""Institute of Psychiatry Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Hodsoll', 'Affiliation': ""Institute of Psychiatry Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Biba', 'Initials': 'B', 'LastName': 'Stanton', 'Affiliation': ""Institute of Psychiatry Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Eskander', 'Affiliation': ""Department of Neurology, King's College Hospital NHS Foundation Trust, London, UK.""}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Stavropoulos', 'Affiliation': ""Department of Clinical Neurophysiology, King's College Hospital NHS Foundation Trust, London, UK.""}, {'ForeName': 'Kiran', 'Initials': 'K', 'LastName': 'Samra', 'Affiliation': ""Department of Neurology, King's College Hospital NHS Foundation Trust, London, UK.""}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Bottini', 'Affiliation': ""Department of Neurology, King's College Hospital NHS Foundation Trust, London, UK.""}, {'ForeName': 'Hena', 'Initials': 'H', 'LastName': 'Ahmad', 'Affiliation': ""Department of Neurology, King's College Hospital NHS Foundation Trust, London, UK.""}, {'ForeName': 'Anthony S', 'Initials': 'AS', 'LastName': 'David', 'Affiliation': 'Institute of Mental Health, University College London, London, UK.'}, {'ForeName': 'Alistair', 'Initials': 'A', 'LastName': 'Purves', 'Affiliation': ""Department of Clinical Neurophysiology, King's College Hospital NHS Foundation Trust, London, UK.""}, {'ForeName': 'Timothy R', 'Initials': 'TR', 'LastName': 'Nicholson', 'Affiliation': ""Institute of Psychiatry Psychology and Neuroscience, King's College London, London, UK timothy.nicholson@kcl.ac.uk.""}]",BMJ open,['10.1136/bmjopen-2020-037198']
3175,33028554,"INtravenous Contrast computed tomography versus native computed tomography in patients with acute Abdomen and impaired Renal functiOn (INCARO): a multicentre, open-label, randomised controlled trial - study protocol.","INTRODUCTION


CT is the primary imaging option for acute abdominal pain in adults. Intravenous (IV) contrast media use improves CT quality but may cause post-contrast acute kidney injury (PC-AKI). Retrospective studies show no association between reduced baseline renal function and IV contrast CT, but, to our knowledge, no data from randomised controlled trials exist.
METHODS AND ANALYSIS


The INCARO (INtravenous Contrast computed tomography versus native computed tomography in patients with acute Abdomen and impaired Renal functiOn) trial is a multicentre, open-label, parallel group, superiority, individually randomised controlled trial comparing IV contrast-enhanced CT to native CT in patients requiring emergency abdominal or body CT with impaired renal function defined as an estimated glomerular filtration rate (eGFR) of 15 to 45 mL/min/1.73 m 2 . The primary outcome is a composite of all-cause mortality or renal replacement therapy (RRT) within 90 days from CT. Secondary outcomes are AKI measured by KDIGO (The Kidney Disease: Improving Global Outcomes) criteria within 72 hours from CT, organ dysfunction defined by mSOFA (modified Sequential Organ Failure Assessment) criteria after 48 hours from CT, alive and hospital-free days within 90 days after CT, and time from imaging to definitive treatment. All-cause mortality, need for RRT and renal transplant in long-term follow-up are also measured. The calculated sample size is 994 patients. Patient recruitment is estimated to take 3 years.
ETHICS AND DISSEMINATION


The Ethics Committee of Helsinki University Hospital approved the study. The findings will be disseminated in peer-reviewed academic journals.
TRIAL REGISTRATION NUMBER


NCT04196244.",2020,The primary outcome is a composite of all-cause mortality or renal replacement therapy (RRT) within 90 days from CT.,"['patients with acute Abdomen and impaired Renal functiOn (INCARO', 'acute abdominal pain in adults', 'patients requiring emergency abdominal or body CT with impaired renal function defined as an estimated glomerular filtration rate (eGFR) of 15 to 45\u2009mL/min/1.73 m 2 ', '994 patients', 'patients with acute Abdomen and impaired Renal functiOn']","['IV contrast-enhanced CT to native CT', 'INtravenous Contrast computed tomography versus native computed tomography', 'INCARO (INtravenous Contrast computed tomography versus native computed tomography', 'Intravenous (IV) contrast media']","['CT quality', 'AKI measured by KDIGO (The Kidney Disease: Improving Global Outcomes) criteria within 72 hours from CT, organ dysfunction defined by mSOFA (modified Sequential Organ Failure Assessment) criteria after 48 hours from CT, alive and hospital-free days', 'composite of all-cause mortality or renal replacement therapy (RRT']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0000727', 'cui_str': 'Acute abdomen'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0740577', 'cui_str': 'Acute abdominal pain'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1292423', 'cui_str': '72 hours'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0349410', 'cui_str': 'Single organ dysfunction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}]",,0.168253,The primary outcome is a composite of all-cause mortality or renal replacement therapy (RRT) within 90 days from CT.,"[{'ForeName': 'Panu', 'Initials': 'P', 'LastName': 'Räty', 'Affiliation': 'Department of Abdominal Surgery, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Panu', 'Initials': 'P', 'LastName': 'Mentula', 'Affiliation': 'Department of Abdominal Surgery, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Lampela', 'Affiliation': 'Department of Abdominal Surgery, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Taina', 'Initials': 'T', 'LastName': 'Nykänen', 'Affiliation': 'Department of Surgery, Hyvinkää Hospital, Hyvinkää, Finland.'}, {'ForeName': 'Ilkka', 'Initials': 'I', 'LastName': 'Helanterä', 'Affiliation': 'Department of Transplantation and Liver Surgery, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Mikko', 'Initials': 'M', 'LastName': 'Haapio', 'Affiliation': 'Nephrology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Tiina', 'Initials': 'T', 'LastName': 'Lehtimäki', 'Affiliation': 'Department of Radiology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Markus B', 'Initials': 'MB', 'LastName': 'Skrifvars', 'Affiliation': 'Department of Emergency Care and Services, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Suvi T', 'Initials': 'ST', 'LastName': 'Vaara', 'Affiliation': 'Division of Intensive Care Medicine, Department of Anesthesiology, Intensive Care and Pain Medicine, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Ari', 'Initials': 'A', 'LastName': 'Leppäniemi', 'Affiliation': 'Department of Abdominal Surgery, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Ville', 'Initials': 'V', 'LastName': 'Sallinen', 'Affiliation': 'Department of Abdominal Surgery, University of Helsinki and Helsinki University Hospital, Helsinki, Finland ville.sallinen@helsinki.fi.'}]",BMJ open,['10.1136/bmjopen-2020-037928']
3176,33028555,"The efficacy and safety of varenicline alone versus in combination with nicotine lozenges for smoking cessation among hospitalised smokers (VANISH): study protocol for a randomised, placebo-controlled trial.","INTRODUCTION


Smoking is a leading cause of premature deaths globally. The health benefits of smoking cessation are many. However, majority of quit attempts are unsuccessful. One way to potentially improve success rates is to evaluate new combinations of existing smoking cessation therapies that may work synergistically to decrease the intensity of withdrawal symptoms and cravings.
AIMS


To evaluate the feasibility, efficacy and safety of the combination of varenicline and nicotine replacement therapy (NRT) lozenges versus varenicline alone in assisting hospitalised smokers to quit.
METHODS AND ANALYSIS


This is a multicentre, randomised, placebo-controlled trial. Adults with a history of smoking ≥10 cigarettes per day on average in the 4 weeks prior to their hospitalisation will be recruited. Participants will be randomly assigned to either the intervention group and will receive varenicline and NRT lozenges, or the control group and will receive varenicline and placebo lozenges. All participants will be actively referred to behavioural support from telephone Quitline. Participants are followed up at 1 and 3 weeks and 3, 6 and 12 months from the start of treatment. The primary outcome is carbon monoxide validated prolonged abstinence from 2 weeks to 6 months after treatment initiation. Secondary outcomes include self-reported and biochemically validated prolonged and point prevalence abstinence at 3, 6 and 12 months, self-reported adverse events, withdrawal symptoms and cravings, adherence to treatment, Quitline sessions attended and others. According to the Russell Standard, all randomised participants will be accounted for in the primary intention-to-treat analysis.
ETHICS AND DISSEMINATION


The trial will be conducted in compliance with the protocol, the principles of Good Clinical Practice, the National Health and Medical Research Council National Statement on Ethical Conduct in Human Research (updated 2015) and the Australian Code for the Responsible Conduct of Research (2018). Approval will be sought from the Human Ethics Committees of all the participating hospitals and the university. Written informed consent will be obtained from each participant at the time of recruitment.
TRIAL REGISTRATION NUMBER


Australia New Zealand Clinical Trials Registry (ACTRN12618001792213).",2020,"Secondary outcomes include self-reported and biochemically validated prolonged and point prevalence abstinence at 3, 6 and 12 months, self-reported adverse events, withdrawal symptoms and cravings, adherence to treatment, Quitline sessions attended and others.","['All participants will be actively referred to behavioural support from telephone Quitline', 'Adults with a history of smoking ≥10 cigarettes per day on average in the 4\u2009weeks prior to their hospitalisation will be recruited', 'assisting hospitalised smokers to quit', 'hospitalised smokers (VANISH']","['nicotine lozenges', 'varenicline and NRT lozenges, or the control group and will receive varenicline and placebo lozenges', 'varenicline', 'varenicline alone', 'varenicline and nicotine replacement therapy (NRT) lozenges', 'placebo']","['feasibility, efficacy and safety', 'efficacy and safety', 'self-reported and biochemically validated prolonged and point prevalence abstinence at 3, 6 and 12 months, self-reported adverse events, withdrawal symptoms and cravings, adherence to treatment, Quitline sessions attended and others', 'carbon monoxide validated prolonged abstinence', 'intensity of withdrawal symptoms and cravings']","[{'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0042950', 'cui_str': 'Volition'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C1253423', 'cui_str': 'Nicotine Lozenges'}, {'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0991564', 'cui_str': 'Lozenge'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0087169', 'cui_str': 'Withdrawal symptom'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",,0.151259,"Secondary outcomes include self-reported and biochemically validated prolonged and point prevalence abstinence at 3, 6 and 12 months, self-reported adverse events, withdrawal symptoms and cravings, adherence to treatment, Quitline sessions attended and others.","[{'ForeName': 'Rukshar Kaizerali', 'Initials': 'RK', 'LastName': 'Gobarani', 'Affiliation': 'Centre for Medicine Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, Parkville, Victoria, Australia.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Abramson', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Billie', 'Initials': 'B', 'LastName': 'Bonevski', 'Affiliation': 'School of Medicine and Public Health, The University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Gregory R', 'Initials': 'GR', 'LastName': 'Weeks', 'Affiliation': 'Pharmacy Department, Barwon Health, Geelong, Victoria, Australia.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Dooley', 'Affiliation': 'Centre for Medicine Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, Parkville, Victoria, Australia.'}, {'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Smith', 'Affiliation': 'General and Respiratory Medicine, Bendigo Health, Bendigo, Victoria, Australia.'}, {'ForeName': 'Antony', 'Initials': 'A', 'LastName': 'Veale', 'Affiliation': 'Department of Respiratory Medicine, The Queen Elizabeth Hospital, Woodville South, South Australia, Australia.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Webb', 'Affiliation': 'Department of Anaesthesia and Pain Management, Frankston Hospital, Frankston, Victoria, Australia.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Kirsa', 'Affiliation': 'Pharmacy Department, Monash Health, Clayton, Victoria, Australia.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Thomas', 'Affiliation': 'Priority Research Centre for Healthy Lungs, The University of Newcastle Hunter Medical Research Institute, New Lambton, New South Wales, Australia.'}, {'ForeName': 'Alistair', 'Initials': 'A', 'LastName': 'Miller', 'Affiliation': 'Respiratory and Sleep Medicine, Royal Melbourne Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Rudi', 'Initials': 'R', 'LastName': 'Gasser', 'Affiliation': 'Department of General Medicine, Barwon Health, Geelong, Victoria, Australia.'}, {'ForeName': 'Eldho', 'Initials': 'E', 'LastName': 'Paul', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Parkinson', 'Affiliation': 'Pharmacy Department, Monash Health, Clayton, Victoria, Australia.'}, {'ForeName': 'Darshana', 'Initials': 'D', 'LastName': 'Meanger', 'Affiliation': 'Pharmacy Department, Frankston Hospital, Frankston, Victoria, Australia.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Coward', 'Affiliation': 'Department of Anaesthesia, Frankston Hospital, Frankston, Victoria, Australia.'}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Kopsaftis', 'Affiliation': 'Respiratory Medicine and Clinical Practice Unit, The Queen Elizabeth Hospital, Woodville South, South Australia, Australia.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Rofe', 'Affiliation': 'Pharmacy Department, Eastern Health Foundation, Box Hill, Victoria, Australia.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Lee', 'Affiliation': 'Pharmacy Department, Eastern Health Foundation, Box Hill, Victoria, Australia.'}, {'ForeName': 'Johnson', 'Initials': 'J', 'LastName': 'George', 'Affiliation': 'Centre for Medicine Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, Parkville, Victoria, Australia johnson.george@monash.edu.'}]",BMJ open,['10.1136/bmjopen-2020-038184']
3177,33028557,Physical activity and health promotion for nursing staff in elderly care: a study protocol for a randomised controlled trial.,"INTRODUCTION


Nursing staff is burdened by high workload and stress. Furthermore, heavy lifting, as well as transferring nursing home residents, cause lumbar tissue damage and back pain. Exercise intervention studies to reduce work-related problems are rare and the evidence for efficacy of studies among nurses is limited. Studies including targeted analysis of requirements are necessary to generate effective recommendations and tailored interventions for health promotion programmes. The purpose of this multicentred intervention study is to identify work-related problems, to implement health promotion programmes and to evaluate their effectiveness.
METHODS AND ANALYSIS


A randomised controlled trial will be conducted, including a total of 48 nursing home facilities in eight regions of Germany with an estimated sample size of 700 nurses. Standardised ergonomics and posture training (10 weeks, once a week for 20-30 min) and subsequently, back-fitness training (12 weeks, once a week for 45-60 min) will be administered. Following the implementation of standardised health promotion programmes, further demand-oriented interventions can be implemented. The perceived exposure to work-related demands, work-related pain in different parts of the body, health-related quality of life, perceived stress, work-related patterns of behaviour and experience, presentism behaviour, work environment as well as general needs and barriers to health promotion, will be assessed at baseline (pre-test), at 10 weeks (post-test, after ergonomics training), at 22 weeks (post-test, after back-fitness training) and at 34 weeks of the programme (follow-up).
ETHICS AND DISSEMINATION


The study was reviewed and approved by the local ethics committee of the University of Hamburg (AZ: 2018_168). The results of the study will be published in open-access and international journals. Furthermore, the results will be presented in the participating nursing homes and at national and international conferences.
TRIAL REGISTRATION NUMBER


DRKS.de (DRKS00015241).",2020,"The perceived exposure to work-related demands, work-related pain in different parts of the body, health-related quality of life, perceived stress, work-related patterns of behaviour and experience, presentism behaviour, work environment as well as general needs and barriers to health promotion, will be assessed at baseline (pre-test), at 10 weeks (post-test, after ergonomics training), at 22 weeks (post-test, after back-fitness training) and at 34 weeks of the programme (follow-up).
","['48 nursing home facilities in eight regions of Germany with an estimated sample size of 700 nurses', 'nursing staff in elderly care']","['Physical activity and health promotion', 'Standardised ergonomics and posture training', 'Exercise intervention']",[],"[{'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C4517862', 'cui_str': '700'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0028698', 'cui_str': 'Nursing Staffs'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018738', 'cui_str': 'Health promotion'}, {'cui': 'C0086246', 'cui_str': 'Human Engineering'}, {'cui': 'C0454282', 'cui_str': 'Posture training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0878008,"The perceived exposure to work-related demands, work-related pain in different parts of the body, health-related quality of life, perceived stress, work-related patterns of behaviour and experience, presentism behaviour, work environment as well as general needs and barriers to health promotion, will be assessed at baseline (pre-test), at 10 weeks (post-test, after ergonomics training), at 22 weeks (post-test, after back-fitness training) and at 34 weeks of the programme (follow-up).
","[{'ForeName': 'Ann-Kathrin', 'Initials': 'AK', 'LastName': 'Otto', 'Affiliation': 'Department of Human Movement Science, University of Hamburg, Hamburg, Germany ann-kathrin.otto@uni-hamburg.de.'}, {'ForeName': 'Juliane', 'Initials': 'J', 'LastName': 'Pietschmann', 'Affiliation': 'Department of Sport and Health, University of Paderborn, Paderborn, Germany.'}, {'ForeName': 'Luisa-Marie', 'Initials': 'LM', 'LastName': 'Appelles', 'Affiliation': 'Institute of Sports and Sports Science, Karlsruhe Institute of Technology, Karlsruhe, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bebenek', 'Affiliation': 'Institute of Medical Physics, Friedrich-Alexander University Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Laura L', 'Initials': 'LL', 'LastName': 'Bischoff', 'Affiliation': 'Department of Human Movement Science, University of Hamburg, Hamburg, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Hildebrand', 'Affiliation': 'Institute of Sports and Sports Science, Karlsruhe Institute of Technology, Karlsruhe, Germany.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Johnen', 'Affiliation': 'Department of Sports and Exercise Science, University of Stuttgart, Stuttgart, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Jöllenbeck', 'Affiliation': 'Department of Sport and Health, University of Paderborn, Paderborn, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Kemmler', 'Affiliation': 'Institute of Medical Physics, Friedrich-Alexander University Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Klotzbier', 'Affiliation': 'Department of Sports and Exercise Science, University of Stuttgart, Stuttgart, Germany.'}, {'ForeName': 'Heide', 'Initials': 'H', 'LastName': 'Korbus', 'Affiliation': 'Department of Sports and Exercise Science, University of Stuttgart, Stuttgart, Germany.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Rudisch', 'Affiliation': 'Institute of Sport and Exercise Sciences, University of Münster, Münster, Germany.'}, {'ForeName': 'Nadja', 'Initials': 'N', 'LastName': 'Schott', 'Affiliation': 'Department of Sports and Exercise Science, University of Stuttgart, Stuttgart, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Schoene', 'Affiliation': 'Institute of Medical Physics, Friedrich-Alexander University Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Voelcker-Rehage', 'Affiliation': 'Institute of Sport and Exercise Sciences, University of Münster, Münster, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Vogel', 'Affiliation': 'Institute of Sports Sciences, Goethe University of Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Lutz', 'Initials': 'L', 'LastName': 'Vogt', 'Affiliation': 'Institute of Sports Sciences, Goethe University of Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Weigelt', 'Affiliation': 'Department of Sport and Health, University of Paderborn, Paderborn, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Wilke', 'Affiliation': 'Institute of Sports Sciences, Goethe University of Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Zwingmann', 'Affiliation': 'Institute of Human Movement Science and Health, Chemnitz University of Technology, Chemnitz, Germany.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Wollesen', 'Affiliation': 'Biological Psychology and Neuroergonomics, Technical University of Berlin, Berlin, Germany.'}]",BMJ open,['10.1136/bmjopen-2020-038202']
3178,33035075,Acceptability and Feasibility of an Isometric Resistance Exercise Program for Abdominal Cancer Surgery: An Embedded Qualitative Study.,"Although it is recognized in the early stages of cancer recovery that changes in lifestyle including increases in physical activity improves physical function, there are no clear findings whether low versus moderate intensity activity or home or gym exercise offer optimal benefit. Isometric-resistance exercises can be carried out with very little equipment and space and can be performed while patients are bed-bound in hospital or at home. This embedded qualitative study, based in an English hospital trust providing specialist cancer care, was undertaken as a component of a feasibility trial to evaluate the acceptability and feasibility of an isometric-resistance exercise program and explore the suitability of functional assessments by drawing from the experiences of abdominal cancer patients following surgery. Telephone interviews were undertaken with 7 participants in the intervention group, and 8 interviews with the usual care group (n = 15). The gender composition consisted of 11 females and 4 males. Participants' ages ranged from 27 to 84 (M = 60.07, SD = 15.40). Interviews were conducted between August 2017 and May 2018, with audio files digitally recorded and data coded using thematic framework analysis. Our results show that blinding to intervention or usual care was a challenge, participants felt the intervention was safe and suitable aided by the assistance of a research nurse, yet, found the self-completion questionnaire tools hard to complete. Our study provides an insight of trial processes, participants' adherence and completion of exercise interventions, and informs the design and conduct of larger RCTs based on the experiences of abdominal cancer surgery patients.",2020,"Our results show that blinding to intervention or usual care was a challenge, participants felt the intervention was safe and suitable aided by the assistance of a research nurse, yet, found the self-completion questionnaire tools hard to complete.","['11 females and 4 males', 'abdominal cancer surgery patients', 'Abdominal Cancer Surgery', 'abdominal cancer patients following surgery', ""Participants' ages ranged from 27 to 84 (M = 60.07, SD = 15.40""]","['isometric-resistance exercise program', 'Isometric Resistance Exercise Program', 'Isometric-resistance exercises']",['Acceptability and Feasibility'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0153662', 'cui_str': 'Malignant neoplasm of abdomen'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]","[{'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}]",11.0,0.034252,"Our results show that blinding to intervention or usual care was a challenge, participants felt the intervention was safe and suitable aided by the assistance of a research nurse, yet, found the self-completion questionnaire tools hard to complete.","[{'ForeName': 'Ferhana', 'Initials': 'F', 'LastName': 'Hashem', 'Affiliation': 'Centre for Health Service Studies, University of Kent, Canterbury, Kent, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Stephensen', 'Affiliation': 'Physiotherapy Department, East Kent Hospitals University Foundation NHS Trust, Kent and Canterbury Hospital, Canterbury, Kent, United Kingdom.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Bates', 'Affiliation': 'Centre for Health Service Studies, University of Kent, Canterbury, Kent, United Kingdom.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Pellatt-Higgins', 'Affiliation': 'Centre for Health Service Studies, University of Kent, Canterbury, Kent, United Kingdom.'}, {'ForeName': 'Ralph Nobby Peter', 'Initials': 'RNP', 'LastName': 'Hobbs', 'Affiliation': 'Maidstone and Tunbridge Wells NHS Trust, Maidstone, Maidstone Hospital, Hermitage Lane, Maidstone, Kent, United Kingdom.'}, {'ForeName': 'Malcolm', 'Initials': 'M', 'LastName': 'Hopkins', 'Affiliation': 'Maidstone and Tunbridge Wells NHS Trust, Maidstone, Maidstone Hospital, Hermitage Lane, Maidstone, Kent, United Kingdom.'}, {'ForeName': 'Hazel', 'Initials': 'H', 'LastName': 'Woodward', 'Affiliation': 'Maidstone and Tunbridge Wells NHS Trust, Maidstone, Maidstone Hospital, Hermitage Lane, Maidstone, Kent, United Kingdom.'}, {'ForeName': 'Charitini', 'Initials': 'C', 'LastName': 'Stavropoulou', 'Affiliation': 'School of Health Sciences, City University, London, Northampton Square, United Kingdom.'}, {'ForeName': 'Ian L', 'Initials': 'IL', 'LastName': 'Swaine', 'Affiliation': 'Centre for Science and Medicine in Sport and Exercise, University of Greenwich, Gillingham, Chatham, United Kingdom.'}, {'ForeName': 'Haythem', 'Initials': 'H', 'LastName': 'Ali', 'Affiliation': 'Maidstone and Tunbridge Wells NHS Trust, Maidstone, Maidstone Hospital, Hermitage Lane, Maidstone, Kent, United Kingdom.'}]",Cancer control : journal of the Moffitt Cancer Center,['10.1177/1073274820950855']
3179,33035194,A proof-of-concept study on the impact of a chronic pain and physical activity training workshop for exercise professionals.,"Objectives Physical activity is essential for long-term chronic pain management, yet individuals struggle to participate. Exercise professionals, including fitness instructors, and personal trainers, are preferred delivery agents for education and instruction on chronic pain, physical activity, and strategies to use adherence-promoting behavioral skills. However, exercise professionals receive no relevant training during certification or continuing education opportunities to effectively support their participants living with chronic pain. Based on the ORBIT model for early pre-efficacy phases of development and testing of new behavioral treatments, the present Phase IIa proof-of-concept study was conducted. The purpose was to examine the impacts of a newly developed chronic pain and physical activity training workshop on psychosocial outcomes among exercise professionals. Outcomes included knowledge and attitudes regarding chronic pain, attitudes and beliefs about the relationship between pain and impairment, and self-efficacy to educate and instruct participants with chronic pain. Methods Forty-eight exercise professionals (M age=44.4±11.0 years) participated in a three-hour, in-person workshop that was offered at one of four different locations. Participants completed pre- and post-workshop outcome assessment surveys. Results Mixed MANOVA results comparing time (pre- versus post-workshop) by workshop location (sites 1 to 4) illustrated a significant within-subjects time effect (p<0.001). All outcomes significantly improved from pre- to post-workshop (p's<0.001), demonstrating large effect sizes (partial eta-squared values ranging from 0.45 to 0.59). Conclusions Findings offer early phase preliminary support for the effectiveness of the chronic pain and physical activity training workshop for exercise professionals. Based on ORBIT model recommendations, findings warrant future phased testing via a pilot randomized clinical trial as well as testing for impacts that trained professionals have on activity adherence among their clients living with chronic pain. Eventual workshop adoption by exercise professional certification organizations would ensure widespread and sustainable access to qualified exercise professionals to help individuals engage in physical activity. By increasing the capacity of available exercise professionals to deliver effective support, active individuals could better manage their chronic pain and live well.",2020,"All outcomes significantly improved from pre- to post-workshop (p's<0.001), demonstrating large effect sizes (partial eta-squared values ranging from 0.45 to 0.59).","['participants living with chronic pain', 'clients living with chronic pain']","['physical activity training workshop', 'exercise professionals receive no relevant training during certification or continuing education opportunities']","['knowledge and attitudes regarding chronic pain, attitudes and beliefs about the relationship between pain and impairment, and self-efficacy to educate and instruct participants with chronic pain', 'chronic pain, physical activity, and strategies to use adherence-promoting behavioral skills']","[{'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0008942', 'cui_str': 'Clients'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0007836', 'cui_str': 'Certification'}, {'cui': 'C0013626', 'cui_str': 'Continuing Education'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",48.0,0.0595817,"All outcomes significantly improved from pre- to post-workshop (p's<0.001), demonstrating large effect sizes (partial eta-squared values ranging from 0.45 to 0.59).","[{'ForeName': 'Nancy C', 'Initials': 'NC', 'LastName': 'Gyurcsik', 'Affiliation': 'University of Saskatchewan, College of Kinesiology, 87 Campus Drive, Saskatoon, SK, Canada.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Tupper', 'Affiliation': 'Pain Quality Improvement and Research for the Saskatchewan Health Authority, Saskatoon, SK, Canada.'}, {'ForeName': 'Danielle R', 'Initials': 'DR', 'LastName': 'Brittain', 'Affiliation': 'University of Northern Colorado, College of Natural and Health Sciences, Greeley, CO, USA.'}, {'ForeName': 'Lawrence R', 'Initials': 'LR', 'LastName': 'Brawley', 'Affiliation': 'University of Saskatchewan, College of Kinesiology, 87 Campus Drive, Saskatoon, SK, Canada.'}, {'ForeName': 'Miranda A', 'Initials': 'MA', 'LastName': 'Cary', 'Affiliation': 'University of British Columbia, School of Health and Exercise Science, Kelowna, BC, Canada.'}, {'ForeName': 'Don', 'Initials': 'D', 'LastName': 'Ratcliffe-Smith', 'Affiliation': 'University of Saskatchewan, College of Kinesiology, 87 Campus Drive, Saskatoon, SK, Canada.'}, {'ForeName': 'Jocelyn E', 'Initials': 'JE', 'LastName': 'Blouin', 'Affiliation': 'University of Saskatchewan, College of Kinesiology, 87 Campus Drive, Saskatoon, SK, Canada.'}, {'ForeName': 'Mackenzie G', 'Initials': 'MG', 'LastName': 'Marchant', 'Affiliation': 'University of Saskatchewan, College of Kinesiology, 87 Campus Drive, Saskatoon, SK, Canada.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Sessford', 'Affiliation': 'University of Saskatchewan, College of Kinesiology, 87 Campus Drive, Saskatoon, SK, Canada.'}, {'ForeName': 'Laurie-Ann M', 'Initials': 'LM', 'LastName': 'Hellsten', 'Affiliation': 'University of Winnipeg, Faculty of Education, Winnipeg, MB, Canada.'}, {'ForeName': 'Bart E', 'Initials': 'BE', 'LastName': 'Arnold', 'Affiliation': 'University of Saskatchewan, College of Kinesiology, 87 Campus Drive, Saskatoon, SK, Canada.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Downe', 'Affiliation': 'University of Saskatchewan, Department of Archaeology and Anthropology, Saskatoon, SK, Canada.'}]",Scandinavian journal of pain,['10.1515/sjpain-2020-0089']
3180,33035206,Impact of providing free HIV self-testing kits on frequency of testing among men who have sex with men and their sexual partners in China: A randomized controlled trial.,"BACKGROUND


The HIV epidemic is rapidly growing among men who have sex with men (MSM) in China, yet HIV testing remains suboptimal. We aimed to determine the impact of HIV self-testing (HIVST) interventions on frequency of HIV testing among Chinese MSM and their sexual partners.
METHODS AND FINDINGS


This randomized controlled trial was conducted in 4 cities in Hunan Province, China. Sexually active and HIV-negative MSM were recruited from communities and randomly assigned (1:1) to intervention or control arms. Participants in the control arm had access to site-based HIV testing (SBHT); those in the intervention arm were provided with 2 free finger-prick-based HIVST kits at enrollment and could receive 2 to 4 kits delivered through express mail every 3 months for 1 year in addition to SBHT. They were encouraged to distribute HIVST kits to their sexual partners. The primary outcome was the number of HIV tests taken by MSM participants, and the secondary outcome was the number of HIV tests taken by their sexual partners during 12 months of follow-up. The effect size for the primary and secondary outcomes was evaluated as the standardized mean difference (SMD) in testing frequency between intervention and control arms. Between April 14, 2018, and June 30, 2018, 230 MSM were recruited. Mean age was 29 years; 77% attended college; 75% were single. The analysis population who completed at least one follow-up questionnaire included 110 (93%, 110/118) in the intervention and 106 (95%, 106/112) in the control arm. The average frequency of HIV tests per participant in the intervention arm (3.75) was higher than that in the control arm (1.80; SMD 1.26; 95% CI 0.97-1.55; P < 0.001). This difference was mainly due to the difference in HIVST between the 2 arms (intervention 2.18 versus control 0.41; SMD 1.30; 95% CI 1.01-1.59; P < 0.001), whereas the average frequency of SBHT was comparable (1.57 versus 1.40, SMD 0.14; 95% CI -0.13 to 0.40; P = 0.519). The average frequency of HIV tests among sexual partners of each participant was higher in intervention than control arm (2.65 versus 1.31; SMD 0.64; 95% CI 0.36-0.92; P < 0.001), and this difference was also due to the difference in HIVST between the 2 arms (intervention 1.41 versus control 0.36; SMD 0.75; 95% CI 0.47-1.04; P < 0.001) but not SBHT (1.24 versus 0.96; SMD 0.23; 95% CI -0.05 to 0.50; P = 0.055). Zero-inflated Poisson regression analyses showed that the likelihood of taking HIV testing among intervention participants were 2.1 times greater than that of control participants (adjusted rate ratio [RR] 2.10; 95% CI 1.75-2.53, P < 0.001), and their sexual partners were 1.55 times more likely to take HIV tests in the intervention arm compared with the control arm (1.55, 1.23-1.95, P < 0.001). During the study period, 3 participants in the intervention arm and none in the control arm tested HIV positive, and 8 sexual partners of intervention arm participants also tested positive. No other adverse events were reported. Limitations in this study included the data on number of SBHT were solely based on self-report by the participants, but self-reported number of HIVST in the intervention arm was validated; the number of partner HIV testing was indirectly reported by participants because of difficulties in accessing each of their partners.
CONCLUSIONS


In this study, we found that providing free HIVST kits significantly increased testing frequency among Chinese MSM and effectively enlarged HIV testing coverage by enhancing partner HIV testing through distribution of kits within their sexual networks.
TRIAL REGISTRATION


Chinese Clinical Trial Registry ChiCTR1800015584.",2020,"The average frequency of HIV tests among sexual partners of each participant was higher in intervention than control arm (2.65 versus 1.31; SMD 0.64; 95% CI 0.36-0.92; P < 0.001), and this difference was also due to the difference in HIVST between the 2 arms (intervention 1.41 versus control 0.36; SMD 0.75; 95% CI 0.47-1.04; P < 0.001) but not SBHT (1.24 versus 0.96; SMD 0.23; 95% CI -0.05 to 0.50; P = 0.055).","['3 participants in the intervention arm and none in the control arm tested HIV positive, and 8 sexual partners of intervention arm participants also tested positive', 'Chinese MSM and their sexual partners', 'men who have sex with men and their sexual partners in China', '4 cities in Hunan Province, China', 'men who have sex with men (MSM) in China', 'Between April 14, 2018, and June 30, 2018, 230 MSM were recruited', 'Sexually active and HIV-negative MSM', 'Mean age was 29 years; 77% attended college; 75% were single']","['free HIV self-testing kits', '2 free finger-prick-based HIVST kits at enrollment and could receive 2 to 4 kits delivered through express mail every 3 months for 1 year in addition to SBHT', 'HIV self-testing (HIVST) interventions']","['frequency of HIV testing', 'number of HIV tests', 'HIVST', 'number of HIV tests taken by their sexual partners', 'adverse events', 'access to site-based HIV testing (SBHT', 'average frequency of SBHT', 'average frequency of HIV tests', 'likelihood of taking HIV testing']","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0019699', 'cui_str': 'HIV positive'}, {'cui': 'C0036911', 'cui_str': 'Sexual partners'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0241028', 'cui_str': 'Sexually active'}, {'cui': 'C0481430', 'cui_str': 'HIV negative'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0037179', 'cui_str': 'Single person'}]","[{'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0812225', 'cui_str': 'Device kit'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0332179', 'cui_str': 'Trimonthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0459958', 'cui_str': 'HIV screening'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0459958', 'cui_str': 'HIV screening'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0036911', 'cui_str': 'Sexual partners'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C2945843', 'cui_str': 'Site of'}, {'cui': 'C0033204', 'cui_str': 'Probability'}]",230.0,0.169548,"The average frequency of HIV tests among sexual partners of each participant was higher in intervention than control arm (2.65 versus 1.31; SMD 0.64; 95% CI 0.36-0.92; P < 0.001), and this difference was also due to the difference in HIVST between the 2 arms (intervention 1.41 versus control 0.36; SMD 0.75; 95% CI 0.47-1.04; P < 0.001) but not SBHT (1.24 versus 0.96; SMD 0.23; 95% CI -0.05 to 0.50; P = 0.055).","[{'ForeName': 'Ci', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Xiangya School of Nursing, Central South University, Changsha, Hunan Province, China.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Koniak-Griffin', 'Affiliation': 'School of Nursing, University of California at Los Angeles, Los Angeles, California, United States of America.'}, {'ForeName': 'Han-Zhu', 'Initials': 'HZ', 'LastName': 'Qian', 'Affiliation': 'Xiangya School of Nursing, Central South University, Changsha, Hunan Province, China.'}, {'ForeName': 'Lloyd A', 'Initials': 'LA', 'LastName': 'Goldsamt', 'Affiliation': 'Rory Meyers College of Nursing, New York University, New York, New York, United States of America.'}, {'ForeName': 'Honghong', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Xiangya School of Nursing, Central South University, Changsha, Hunan Province, China.'}, {'ForeName': 'Mary-Lynn', 'Initials': 'ML', 'LastName': 'Brecht', 'Affiliation': 'School of Nursing, University of California at Los Angeles, Los Angeles, California, United States of America.'}, {'ForeName': 'Xianhong', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Xiangya School of Nursing, Central South University, Changsha, Hunan Province, China.'}]",PLoS medicine,['10.1371/journal.pmed.1003365']
3181,33035741,"Differentiating ""types"" of treatment dropout: Nonstarters in an RCT of prolonged exposure versus sertraline.","Despite effective interventions for posttraumatic stress disorder (PTSD), many patients prematurely drop out. Differentiating ""types"" of dropout at various stages of treatment may improve our ability to predict and prevent attrition. Using data from a doubly randomized preference trial, this study examined patient dropout prior to treatment and compared these ""nonstarters"" with treatment starters and in-treatment dropouts. Patients (N = 200) with chronic PTSD were randomized to ""choice"" (prolonged exposure [PE] or sertraline) or ""no choice"" (re-randomized to PE or sertraline) and received up to 10 weeks of treatment. Overall dropout rate was 33.0% (n = 66). A substantial minority were nonstarters (n = 19; 28.8%). Relative to patients who began treatment, nonstarters reported less severe PTSD symptomatology (p = .03, d = 0.57) and were less likely to have received their preferred treatment (p < .001). These differences remained even when comparing nonstarters to patients that began treatment but eventually dropped out. Differences in beliefs (i.e., perceived credibility) toward one treatment versus the other were also linked to pretreatment dropout. Reasons underlying dropout likely differ during various treatment stages. Better understanding risk factors for types of dropout may inform strategies to boost engagement and retention, ultimately improving patient outcomes.",2020,"Relative to patients who began treatment, nonstarters reported less severe PTSD symptomatology (p = .03, d = 0.57) and were less likely to have received their preferred treatment (p < .001).",['Patients (N\xa0=\xa0200) with chronic PTSD'],"['choice"" (prolonged exposure [PE] or sertraline) or ""no choice"" (re-randomized to PE or sertraline', 'sertraline']","['Overall dropout rate', 'severe PTSD symptomatology']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0730525', 'cui_str': 'Chronic post-traumatic stress disorder'}]","[{'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}]",200.0,0.0323563,"Relative to patients who began treatment, nonstarters reported less severe PTSD symptomatology (p = .03, d = 0.57) and were less likely to have received their preferred treatment (p < .001).","[{'ForeName': 'Alexander C', 'Initials': 'AC', 'LastName': 'Kline', 'Affiliation': 'PTSD Treatment and Research Program, Case Western Reserve University, Department of Psychological Sciences, 11220 Bellflower Road, Cleveland, OH, 44106-7123, USA. Electronic address: ack63@case.edu.'}, {'ForeName': 'Allison L', 'Initials': 'AL', 'LastName': 'Baier', 'Affiliation': 'PTSD Treatment and Research Program, Case Western Reserve University, Department of Psychological Sciences, 11220 Bellflower Road, Cleveland, OH, 44106-7123, USA.'}, {'ForeName': 'Alexandra B', 'Initials': 'AB', 'LastName': 'Klein', 'Affiliation': 'PTSD Treatment and Research Program, Case Western Reserve University, Department of Psychological Sciences, 11220 Bellflower Road, Cleveland, OH, 44106-7123, USA.'}, {'ForeName': 'Norah C', 'Initials': 'NC', 'LastName': 'Feeny', 'Affiliation': 'PTSD Treatment and Research Program, Case Western Reserve University, Department of Psychological Sciences, 11220 Bellflower Road, Cleveland, OH, 44106-7123, USA.'}, {'ForeName': 'Lori A', 'Initials': 'LA', 'LastName': 'Zoellner', 'Affiliation': 'Center for Anxiety and Traumatic Stress, University of Washington, Department of Psychology, Guthrie Hall, Box 351525, Seattle, WA, 98195-1525, USA.'}]",Behaviour research and therapy,['10.1016/j.brat.2020.103750']
3182,33035763,Effect of oral health intervention on cognitive decline in community-dwelling older adults: A randomized controlled trial.,"PURPOSE


The incidence of dementia is rapidly increasing worldwide, especially in developed countries. Little is known regarding the effectiveness of dental intervention to prevent dementia or a decline in cognitive functions among community-dwelling older adults, but a few studies have reported a correlation between the lack of regular dental checkups and dementia. For that reason, this study aimed to investigate the effects of oral health intervention on cognitive functions in community-dwelling subjects with a mild cognitive decline via a randomized controlled trial.
PATIENTS AND METHODS


Fifty-five community-dwelling older adults with a Mini-Mental State Examination score of ≥21 to ≤26 who had not visited a dental clinic in the previous year were randomized to an intervention group (n = 28) or a control group (n = 29). The intervention group received monthly oral health intervention by dental hygienists for 8 months while the control group did not. Data on demographics, cognitive function and oral parameters were collected before and after the intervention.
RESULTS


Twenty-five subjects in the intervention group (mean age 77.0 years) and 25 in the control group (mean age 72.8 years) completed the study. Significant improvements were observed in the Trail Making Test (TMT)-A, TMT-B, bleeding on probing rate, oral diadochokinesis, tongue pressure and chewing ability in the intervention group (P < 0.05). There were also significant interactions between the TMT-A and TMT-B scores, oral diadochokinesis, tongue pressure and chewing ability (P < 0.05).
CONCLUSION


Oral health intervention by dental hygienists may be effective for improving the oral health and executive function of cognitive function assessed via TMT.",2020,"Significant improvements were observed in the Trail Making Test (TMT)-A, TMT-B, bleeding on probing rate, oral diadochokinesis, tongue pressure and chewing ability in the intervention group (P < 0.05).","['Twenty-five subjects in the intervention group (mean age 77.0 years) and 25 in the control group (mean age 72.8 years) completed the study', 'community-dwelling subjects with a mild cognitive decline via a randomized controlled trial', 'community-dwelling older adults', 'Fifty-five community-dwelling older adults with a Mini-Mental State Examination score of ≥21 to ≤26 who had not visited a dental clinic in the previous year']","['oral health intervention', 'monthly oral health intervention']","['cognitive decline', 'Trail Making Test (TMT)-A, TMT-B, bleeding on probing rate, oral diadochokinesis, tongue pressure and chewing ability', 'cognitive functions', 'demographics, cognitive function and oral parameters', 'TMT-A and TMT-B scores, oral diadochokinesis, tongue pressure and chewing ability']","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0234985', 'cui_str': 'Mental Deterioration'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0450382', 'cui_str': '55'}, {'cui': 'C2960235', 'cui_str': 'Mini-mental state examination score'}, {'cui': 'C0011344', 'cui_str': 'Dental clinic'}, {'cui': 'C0205156', 'cui_str': 'Previous'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0234985', 'cui_str': 'Mental Deterioration'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0278157', 'cui_str': 'Diadochokinesia'}, {'cui': 'C0040408', 'cui_str': 'Tongue structure'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0566339', 'cui_str': 'Ability to chew'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",55.0,0.0438053,"Significant improvements were observed in the Trail Making Test (TMT)-A, TMT-B, bleeding on probing rate, oral diadochokinesis, tongue pressure and chewing ability in the intervention group (P < 0.05).","[{'ForeName': 'Chiaki', 'Initials': 'C', 'LastName': 'Matsubara', 'Affiliation': 'Gerodontology and Oral Rehabilitation, Department of Gerontology and Gerodontology, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8549, Japan. Electronic address: m.chiakingyo@gmail.com.'}, {'ForeName': 'Maki', 'Initials': 'M', 'LastName': 'Shirobe', 'Affiliation': 'Gerodontology and Oral Rehabilitation, Department of Gerontology and Gerodontology, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8549, Japan; Tokyo Metropolitan Institute of Gerontology, 35-2 Sakae-cho, Itabashi-ku, Tokyo 173-0015, Japan. Electronic address: mashirobe@gmail.com.'}, {'ForeName': 'Junichi', 'Initials': 'J', 'LastName': 'Furuya', 'Affiliation': 'Department of Geriatric Dentistry, Showa University School of Dentistry, 2-1-1 Kitasenzoku, Ohta-ku, Tokyo 145-8515, Japan. Electronic address: furuyajunichi@gmail.com.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Watanabe', 'Affiliation': 'Tokyo Metropolitan Institute of Gerontology, 35-2 Sakae-cho, Itabashi-ku, Tokyo 173-0015, Japan; Gerodontology, Department of Oral Health Science, Faculty of Dental Medicine, Hokkaido University, Nishi-7, Kita-13, Kita-ku, Sapporo, 060-8586, Japan. Electronic address: ywata@den.hokudai.ac.jp.'}, {'ForeName': 'Keiko', 'Initials': 'K', 'LastName': 'Motokawa', 'Affiliation': 'Tokyo Metropolitan Institute of Gerontology, 35-2 Sakae-cho, Itabashi-ku, Tokyo 173-0015, Japan. Electronic address: kikiki_1004@yahoo.co.jp.'}, {'ForeName': 'Ayako', 'Initials': 'A', 'LastName': 'Edahiro', 'Affiliation': 'Tokyo Metropolitan Institute of Gerontology, 35-2 Sakae-cho, Itabashi-ku, Tokyo 173-0015, Japan. Electronic address: aedahiro514@gmail.com.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Ohara', 'Affiliation': 'Tokyo Metropolitan Institute of Gerontology, 35-2 Sakae-cho, Itabashi-ku, Tokyo 173-0015, Japan. Electronic address: yohara@tmig.or.jp.'}, {'ForeName': 'Shuichi', 'Initials': 'S', 'LastName': 'Awata', 'Affiliation': 'Tokyo Metropolitan Institute of Gerontology, 35-2 Sakae-cho, Itabashi-ku, Tokyo 173-0015, Japan. Electronic address: awata@tmig.or.jp.'}, {'ForeName': 'Hunkyung', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Tokyo Metropolitan Institute of Gerontology, 35-2 Sakae-cho, Itabashi-ku, Tokyo 173-0015, Japan. Electronic address: kimhk@tmig.or.jp.'}, {'ForeName': 'Yoshinori', 'Initials': 'Y', 'LastName': 'Fujiwara', 'Affiliation': 'Tokyo Metropolitan Institute of Gerontology, 35-2 Sakae-cho, Itabashi-ku, Tokyo 173-0015, Japan. Electronic address: fujiwayo@tmig.or.jp.'}, {'ForeName': 'Shuichi', 'Initials': 'S', 'LastName': 'Obuchi', 'Affiliation': 'Tokyo Metropolitan Institute of Gerontology, 35-2 Sakae-cho, Itabashi-ku, Tokyo 173-0015, Japan. Electronic address: obuchipc@tmig.or.jp.'}, {'ForeName': 'Hirohiko', 'Initials': 'H', 'LastName': 'Hirano', 'Affiliation': 'Tokyo Metropolitan Institute of Gerontology, 35-2 Sakae-cho, Itabashi-ku, Tokyo 173-0015, Japan. Electronic address: h-hiro@gd5.so-net.ne.jp.'}, {'ForeName': 'Shunsuke', 'Initials': 'S', 'LastName': 'Minakuchi', 'Affiliation': 'Gerodontology and Oral Rehabilitation, Department of Gerontology and Gerodontology, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8549, Japan. Electronic address: s.minakuchi.gerd@tmd.ac.jp.'}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2020.104267']
3183,33038782,Effects of chamomile extract nasal drop on chronic rhinosinusitis treatment: A randomized double blind study.,"OBJECTIVES


Recently, more attention has been paid to herbal treatment in chronic rhinosinusitis (CRS) patients. Chamomile (Matrricaria chamomilla) has extensive clinical uses in traditional-Persian medicine for its therapeutic properties. This study aimed to evaluate the effects of chamomile extract on the clinical symptoms of patients with CRS in a university hospital.
MATERIALS AND METHODS


In a randomized double-blind placebo-group clinical trial, 74 CRS patients were examined by an otolaryngologist blinded to the study groups, and the effects of treatment (according to SNOT-22 questionnaire) and possible complications recorded. Statistical analysis performed using SPSS software version 21, and level of significance considered as P < 0.05.
RESULTS


Of the 74 patients (31 females and 43 male), 37 cases randomized in the intervention and 37 cases in the placebo group. The Lund-Mackay score, clinical findings in endoscopic nasal examination and mean score of the SNOT-22 were not significantly different at baseline visit between the two study groups. The adjusted mean score of quality of life during the four time periods in the intervention group (34.3, confidence interval of 95%: 31.8-36.7) was significantly lower than that of control group (45.9, confidence interval of 95%: 43.5-48.4) (P-value = 0.001). Also, clinical improvement in endoscopic nasal examination was significant in intervention group compared with placebo group.
CONCLUSION


Chamomile extract is effective in further reducing the clinical symptoms and improving the quality of life of CRS patients.",2020,Chamomile (Matrricaria chamomilla) has extensive clinical uses in traditional-Persian medicine for its therapeutic properties.,"['74 CRS patients', '74 patients (31 females and 43 male', 'patients with CRS in a university hospital', 'chronic rhinosinusitis treatment', 'chronic rhinosinusitis (CRS) patients']","['chamomile extract nasal drop', 'Chamomile (Matrricaria chamomilla', 'chamomile extract', 'placebo', 'Chamomile extract']","['adjusted mean score of quality of life', 'Lund-Mackay score, clinical findings in endoscopic nasal examination and mean score of the SNOT-22', 'endoscopic nasal examination', 'quality of life']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0149516', 'cui_str': 'Chronic sinusitis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0439963', 'cui_str': 'Chamomile extract'}, {'cui': 'C0991524', 'cui_str': 'Nasal drops'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C5197690', 'cui_str': 'SNOT-22'}]",74.0,0.418448,Chamomile (Matrricaria chamomilla) has extensive clinical uses in traditional-Persian medicine for its therapeutic properties.,"[{'ForeName': 'Shadman', 'Initials': 'S', 'LastName': 'Nemati', 'Affiliation': 'Otorhinolaryngology Research Center, Department of Otolaryngology and Head and Neck Surgery, Amiralmomenin Hospital, School of Medicine, Guilan University of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Yousefbeyk', 'Affiliation': 'Department of Pharmacognosy, School of Pharmacy, Guilan University of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'Seyedeh Matin', 'Initials': 'SM', 'LastName': 'Ebrahimi', 'Affiliation': 'Otorhinolaryngology Research Center, Amiralmomenin Hospital, School of Medicine, Guilan University of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'Ali Faghih', 'Initials': 'AF', 'LastName': 'FaghihHabibi', 'Affiliation': 'Otorhinolaryngology Research Center, Department of Otolaryngology and Head and Neck Surgery, Amiralmomenin Hospital, School of Medicine, Guilan University of Medical Sciences, Rasht, Iran. Electronic address: dr.faghih.habibi@gmail.com.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Shakiba', 'Affiliation': 'Cardiovascular Diseases Research Center, Guilan University of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'Hedieh', 'Initials': 'H', 'LastName': 'Ramezani', 'Affiliation': 'Otorhinolaryngology Research Center, Amiralmomenin Hospital, School of Medicine, Guilan University of Medical Sciences, Rasht, Iran.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102743']
3184,33038832,Effect of omega-3 lcpufa supplementation on maternal fatty acid and oxylipin concentrations during pregnancy.,"INTRODUCTION


Omega-3 long chain polyunsaturated fatty acids (LCPUFA) have been associated with a reduction in risk for preterm birth. However, there is limited understanding of how fatty acids and their bioactive derivatives (oxylipins) change over the course of pregnancy. Here we document the changes in concentration of fatty acids and oxylipins during pregnancy and how fatty acid status and oxylipin concentrations are affected by supplementation with omega-3 LCPUFA. We also investigate the degree to which fatty acid and oxylipin changes across pregnancy are influenced by baseline omega-3 status.
MATERIALS AND METHODS


We profiled the fatty acids in all lipids in dried blood spots (total blood fatty acids) by gas chromatography and free (unesterified) fatty acids and their associated oxylipins in separate dried blood spot samples by LC-MS-MS collected from a random sample of 1263 women with a singleton pregnancy who participated in the ORIP (Omega-3 fats to Reduce the Incidence of Prematurity) trial. ORIP is a double-blind, randomized controlled trial involving 5544 participants and designed to determine the effect of supplementing the diets of pregnant women with omega-3 LCPUFA on the incidence of early preterm birth. Maternal whole blood finger prick samples were collected at baseline (~14 weeks gestation) and at completion of the study intervention period (34 weeks gestation).
RESULTS


The concentration of most total and free polyunsaturated fatty acids and their associated oxylipins declined over the course of pregnancy. Omega-3 LCPUFA supplementation increased total DHA and 7-HDHA and mitigated the decline in free DHA, 4-HDHA and 14-HDHA. The intervention had minimal or no effect on free EPA, LA, AA and their associated oxylipins. Omega-3 LCPUFA supplementation in women with higher omega-3 status at baseline was associated with a significant increase in 7-HDHA and 4-HDHA between the treatment and control whereas there were no differences between groups in 7-HDHA and 4-HDHA in women with intermediate or lower baseline omega-3 status.
CONCLUSION


Our data suggest a differential response with or without omega-3 supplementation for DHA and DHA-derived oxylipins, which may have an important role to play in modulating pregnancy duration. Further work is needed to understand their role, which may allow us to better tailor omega-3 supplementation for preterm birth prevention.",2020,"Omega-3 LCPUFA supplementation increased total DHA and 7-HDHA and mitigated the decline in free DHA, 4-HDHA and 14-HDHA.","['5544 participants', '1263 women with a singleton pregnancy who participated in the ORIP (Omega-3 fats to Reduce the Incidence of Prematurity) trial', 'pregnant women with']","['Omega-3 long chain polyunsaturated fatty acids (LCPUFA', 'omega-3 lcpufa supplementation', 'omega-3 LCPUFA', 'dried blood spots (total blood fatty acids) by gas chromatography and free (unesterified) fatty acids and their associated oxylipins', 'ORIP', 'Omega-3 LCPUFA supplementation']","['incidence of early preterm birth', '7-HDHA and 4-HDHA', 'Maternal whole blood finger prick samples', 'total DHA and 7-HDHA', 'free EPA, LA, AA and their associated oxylipins', 'maternal fatty acid and oxylipin concentrations', 'concentration of most total and free polyunsaturated fatty acids']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}]","[{'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008555', 'cui_str': 'Gas chromatography measurement'}, {'cui': 'C0015688', 'cui_str': 'Unesterified fatty acid'}, {'cui': 'C1956100', 'cui_str': 'Oxylipins'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0142831', 'cui_str': 'sodium dehydroacetate'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C1956100', 'cui_str': 'Oxylipins'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",5544.0,0.103295,"Omega-3 LCPUFA supplementation increased total DHA and 7-HDHA and mitigated the decline in free DHA, 4-HDHA and 14-HDHA.","[{'ForeName': 'K P', 'Initials': 'KP', 'LastName': 'Best', 'Affiliation': 'South Australian Health and Medical Research Institute, SAHMRI Women and Kids, North Terrace, Adelaide SA; School of Medicine, University of Adelaide, North Terrace, Adelaide SA. Electronic address: karen.best@sahmri.com.'}, {'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Gibson', 'Affiliation': 'South Australian Health and Medical Research Institute, SAHMRI Women and Kids, North Terrace, Adelaide SA; School of Agriculture, Food and Wine, University of Adelaide, North Terrace, Adelaide SA.'}, {'ForeName': 'L N', 'Initials': 'LN', 'LastName': 'Yelland', 'Affiliation': 'South Australian Health and Medical Research Institute, SAHMRI Women and Kids, North Terrace, Adelaide SA; School of Public Health, University of Adelaide, North Terrace, Adelaide SA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Leemaqz', 'Affiliation': 'South Australian Health and Medical Research Institute, SAHMRI Women and Kids, North Terrace, Adelaide SA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Gomersall', 'Affiliation': 'South Australian Health and Medical Research Institute, SAHMRI Women and Kids, North Terrace, Adelaide SA; School of Public Health, University of Adelaide, North Terrace, Adelaide SA.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Liu', 'Affiliation': 'South Australian Health and Medical Research Institute, SAHMRI Women and Kids, North Terrace, Adelaide SA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Makrides', 'Affiliation': 'South Australian Health and Medical Research Institute, SAHMRI Women and Kids, North Terrace, Adelaide SA; School of Medicine, University of Adelaide, North Terrace, Adelaide SA.'}]","Prostaglandins, leukotrienes, and essential fatty acids",['10.1016/j.plefa.2020.102181']
3185,33038833,"Long-term docosahexaenoic acid (DHA) supplementation in cystic fibrosis patients: a randomized, multi-center, double-blind, placebo-controlled trial.","BACKGROUND


Cystic fibrosis (CF) patients have an alteration in fatty acid (FA) metabolism, associated with increased omega-6 and low omega-3 FA. Previous studies on supplementation with omega-3 FA in CF had contradictory results, and to date there is no evidence to recommend routine use of omega-3 supplements in CF patients. We hypothesized that long-term supplementation with docosahexaenoic acid (DHA) will have beneficial effects in these patients, by reducing pulmonary, systemic and intestinal inflammation.
METHODS


This was a randomized, double-blind, parallel, placebo-controlled trial. CF patients (age >2 months) were randomized to receive a seaweed DHA oil solution (50 mg/Kg/day) or matching placebo for 48 weeks. Primary outcomes were pulmonary (interleukin [IL]-8), systemic (IL-8) and intestinal (calprotectin) inflammatory biomarkers. Secondary outcomes included other pulmonary (IL-1β, IL-6, neutrophil elastase, lactate and calprotectin) and systemic (serum-IL-1β, IL-6) inflammatory biomarkers, as well as clinical outcomes (FEV 1 , pulmonary exacerbations, antibiotic use, nutritional status and quality of life).
RESULTS


Ninety six CF patients, 44 female, age 14.6±11.9 years (48 DHA and 48 placebo) were included. At trial completion, there were no differences in all primary outcomes [serum-IL-8 (p=0.909), respiratory-IL-8 (p=0.384) or fecal calprotectin (p=0.948)], all secondary inflammatory biomarkers, or in any of the clinical outcomes evaluated. There were few adverse events, with similar incidence in both study groups.
CONCLUSION


In this study, long-term DHA supplementation in CF patients was safe, but did not offer any benefit on inflammatory biomarkers, or in clinical outcomes compared with placebo. (NCT01783613).",2020,"Secondary outcomes included other pulmonary (IL-1β, IL-6, neutrophil elastase, lactate and calprotectin) and systemic (serum-IL-1β, IL-6) inflammatory biomarkers, as well as clinical outcomes (FEV 1 , pulmonary exacerbations, antibiotic use, nutritional status and quality of life).
","['cystic fibrosis patients', 'Ninety six CF patients, 44 female, age 14.6±11.9 years (48 DHA and 48', 'Cystic fibrosis (CF) patients', 'CF patients', 'CF patients (age >2 months']","['docosahexaenoic acid (DHA) supplementation', 'seaweed DHA oil solution', 'placebo', 'matching placebo', 'docosahexaenoic acid (DHA']","['serum-IL-8 (p=0.909), respiratory-IL-8 (p=0.384) or fecal calprotectin (p=0.948)], all secondary inflammatory biomarkers', 'pulmonary (IL-1β, IL-6, neutrophil elastase, lactate and calprotectin) and systemic (serum-IL-1β, IL-6) inflammatory biomarkers, as well as clinical outcomes (FEV 1 , pulmonary exacerbations, antibiotic use, nutritional status and quality of life', 'pulmonary (interleukin [IL]-8), systemic (IL-8) and intestinal (calprotectin) inflammatory biomarkers']","[{'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0036500', 'cui_str': 'Macroalgae'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C1964053', 'cui_str': 'Faecal calprotectin'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0064833', 'cui_str': 'Leukocyte elastase'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0950624', 'cui_str': 'Calprotectin'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}]",96.0,0.816089,"Secondary outcomes included other pulmonary (IL-1β, IL-6, neutrophil elastase, lactate and calprotectin) and systemic (serum-IL-1β, IL-6) inflammatory biomarkers, as well as clinical outcomes (FEV 1 , pulmonary exacerbations, antibiotic use, nutritional status and quality of life).
","[{'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'López-Neyra', 'Affiliation': 'Unidad de Fibrosis Quística. Servicio de Pediatría. Hospital Universitario Ramón y Cajal. Cª Colmenar Km. 9,1. 28034-Madrid. Spain; Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS). Cª Colmenar Km. 9,1. 28034-Madrid. Spain. Electronic address: alneyra@salud.madrid.org.'}, {'ForeName': 'Lucrecia', 'Initials': 'L', 'LastName': 'Suárez', 'Affiliation': 'Unidad de Fibrosis Quística. Servicio de Pediatría. Hospital Universitario Ramón y Cajal. Cª Colmenar Km. 9,1. 28034-Madrid. Spain; Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS). Cª Colmenar Km. 9,1. 28034-Madrid. Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Muñoz', 'Affiliation': 'Unidad de Fibrosis Quística. Servicio de Pediatría. Hospital Universitario Ramón y Cajal. Cª Colmenar Km. 9,1. 28034-Madrid. Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'de Blas', 'Affiliation': 'Unidad de Fibrosis Quística. Servicio de Pediatría. Hospital Universitario Ramón y Cajal. Cª Colmenar Km. 9,1. 28034-Madrid. Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Ruiz de Valbuena', 'Affiliation': 'Unidad de Fibrosis Quística. Servicio de Pediatría. Hospital Universitario Ramón y Cajal. Cª Colmenar Km. 9,1. 28034-Madrid. Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Garriga', 'Affiliation': 'Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS). Cª Colmenar Km. 9,1. 28034-Madrid. Spain; Unidad de Fibrosis Quística. Servicio de Endocrinología. Hospital Universitario Ramón y Cajal. Cª Colmenar Km. 9,1. 28034-Madrid. Spain.'}, {'ForeName': 'Joaquim', 'Initials': 'J', 'LastName': 'Calvo', 'Affiliation': 'Unidad de Fibrosis Quística. Servicio de Pediatría. Hospital Universitario La Fe. Avinguda de Fernando Abril Martorell, 106. 46026-Valencia. Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Ribes', 'Affiliation': 'Unidad de Fibrosis Quística. Servicio de Pediatría. Hospital Universitario La Fe. Avinguda de Fernando Abril Martorell, 106. 46026-Valencia. Spain.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Girón Moreno', 'Affiliation': 'Unidad de Fibrosis Quística. Servicio de Neumología. Hospital Universitario La Princesa. Instituto de Investigación Sanitaria La Princesa. Calle de Diego de León, 62. 28006-Madrid. Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Máiz', 'Affiliation': 'Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS). Cª Colmenar Km. 9,1. 28034-Madrid. Spain; Unidad de Fibrosis Quística. Servicio de Neumología. Hospital Universitario Ramón y Cajal. Cª Colmenar Km. 9,1. 28034-Madrid. Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'González', 'Affiliation': 'Unidad de Fibrosis Quística. Servicio de Pediatría. Hospital Universitario Central de Asturias. Av. Roma. 33011-Oviedo. Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Bousoño', 'Affiliation': 'Unidad de Fibrosis Quística. Servicio de Pediatría. Hospital Universitario Central de Asturias. Av. Roma. 33011-Oviedo. Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Manzanares', 'Affiliation': 'Unidad de Fibrosis Quística. Servicio de Pediatría. Hospital Universitario Doce de Octubre. Avda. de Córdoba. 28041-Madrid. Spain.'}, {'ForeName': 'Óscar', 'Initials': 'Ó', 'LastName': 'Pastor', 'Affiliation': 'Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS). Cª Colmenar Km. 9,1. 28034-Madrid. Spain; Servicio de Bioquímica Clínica, UCA-CCM. Hospital Universitario Ramón y Cajal. Cª Colmenar Km. 9,1. 28034-Madrid. Spain; CIBER Fisiopatología Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III. Av. Monforte de Lemos, 3-5. 28029-Madrid. Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Martínez-Botas', 'Affiliation': 'Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS). Cª Colmenar Km. 9,1. 28034-Madrid. Spain; CIBER Fisiopatología Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III. Av. Monforte de Lemos, 3-5. 28029-Madrid. Spain; Servicio de Bioquímica-Investigación. Hospital Universitario Ramón y Cajal. Cª Colmenar Km. 9,1. 28034-Madrid. Spain.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Del Campo', 'Affiliation': 'Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS). Cª Colmenar Km. 9,1. 28034-Madrid. Spain; Servicio de Microbiología, Hospital Universitario Ramón y Cajal. Cª Colmenar Km. 9,1. 28034-Madrid. Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Cantón', 'Affiliation': 'Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS). Cª Colmenar Km. 9,1. 28034-Madrid. Spain; Servicio de Microbiología, Hospital Universitario Ramón y Cajal. Cª Colmenar Km. 9,1. 28034-Madrid. Spain.'}, {'ForeName': 'Garbiñe', 'Initials': 'G', 'LastName': 'Roy', 'Affiliation': 'Servicio de Inmunología, Hospital Universitario Ramón y Cajal. Cª Colmenar Km. 9,1. 28034-Madrid. Spain.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Menacho', 'Affiliation': 'Servicio de Bioquímica Clínica, Hospital Universitario Ramón y Cajal. Cª Colmenar Km. 9,1. 28034-Madrid. Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Arroyo', 'Affiliation': 'Unidad de Bioestadística Clínica, Hospital Universitario Ramón y Cajal. Cª Colmenar Km. 9,1. 28034-Madrid. Spain; CIBER Epidemiología y Salud Pública (CIBERESP), Instituto de Salud Carlos III. Av. Monforte de Lemos, 3-5. 28029-Madrid. Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Zamora', 'Affiliation': 'Unidad de Bioestadística Clínica, Hospital Universitario Ramón y Cajal. Cª Colmenar Km. 9,1. 28034-Madrid. Spain; CIBER Epidemiología y Salud Pública (CIBERESP), Instituto de Salud Carlos III. Av. Monforte de Lemos, 3-5. 28029-Madrid. Spain.'}, {'ForeName': 'Joan B', 'Initials': 'JB', 'LastName': 'Soriano', 'Affiliation': 'Hospital Universitario La Princesa. Universidad Autónoma de Madrid. Calle de Diego de León, 62. 28006-Madrid. Spain; Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Instituto de Salud Carlos III. Av. Monforte de Lemos, 3-5. 28029-Madrid. Spain.'}, {'ForeName': 'Adelaida', 'Initials': 'A', 'LastName': 'Lamas', 'Affiliation': 'Unidad de Fibrosis Quística. Servicio de Pediatría. Hospital Universitario Ramón y Cajal. Cª Colmenar Km. 9,1. 28034-Madrid. Spain; Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS). Cª Colmenar Km. 9,1. 28034-Madrid. Spain.'}]","Prostaglandins, leukotrienes, and essential fatty acids",['10.1016/j.plefa.2020.102186']
3186,33023430,NGS of microRNAs involved in cardioprotection induced by sevoflurane compared to propofol in myocardial revascularization surgery: The ACDHUVV-16 Clinical Trial.,"BACKGROUND


Numerous studies have demonstrated that halogenated agents elicit myocardial conditioning effects when adminis-tered perioperatively in cardiac surgery. Recent evidence has been published of the benefits of maintaining exposure to halogenated agents during the early postoperative period. The enzymatic mechanisms by which this beneficial effect is exerted were explained recently.
OBJECTIVES


Our study was performed to investigate whether this phenomenon is mediated by either the activation or suppression of miR-NAs targeted by halogenated anesthetics.
METHODS


A double-blind, two-stage trial was conducted. The results of the first stage of the trial are presented in this paper. The sample was composed of patients undergoing off-pump myocardial revascularization surgery. Patients were randomized to receive either sevoflu-rane [S] or propofol [P] during the intraoperative and early postoperative period (during the first six hours after the intervention). Hemody-namics (heart rate, blood pressure, central venous pressure, cardiac index, systolic volume index, LVEF) and myocardial enzymes (troponin I) were monitored at six hour intervals during the first 48 hours. In the first stage of the trial, blood was drawn for gene sequencing from eight patients (four per group) at baseline and at 24 h. In the second stage of the study, a qPCR analysis was performed of the miRNAs identified as significant by gene sequencing. Levels of cardioprotective enzymes (serine/threonine protein kinase (Akt), tumor necrosis fac-tor alpha (TNFα), extracellular regulated protein kinase (ERK 1/2), and caspase 3) were measured to assess their role in myocardial condi-tioning pathways. The purpose was to identify the miRNAs that play a major role in myocardial conditioning induced by halogenated agents. Concentrations of cardioprotective enzymes were higher in patients who received sevoflurane, as compared to patients who were administered propofol.
RESULTS


NGS differences were observed between baseline and 24-h values in the two study groups. In group P, miRNA 197-3p was over-expressed, whereas miRNAs 4443 and 1294, 708-3p were underexpressed. In group S, miRNAs 615-3p, 4466, 29, 937-3p, 636, 197-3P, 184, 4685, 296-3p, 147b, 3199, 6815, 1294 and 3176 were underexpressed; whereas 708-3p was overexpressed. qPCR showed significant variations in miRNAs 197-3p, 4443, 708-3p and 1294 in the P group, and in miRNAs 937-3p, 636, 197-3p, 296-3p and 708-3p in the S group.
CONCLUSIONS


In the P Group, changes in the expression of some miRNAs were associated with lower concentrations of the enzymes in-volved in myocardial pre- and postconditioning. In contrast, in Group S, variations in miRNAs were associated with the activation of medi-ators of anesthetic-induced pre- and post-conditioning, a reduction in cell apoptosis, and a decrease in caspase and TnBF alpha concentra-tions. Changes in these miRNAs were associated with a better prognosis in patients with ischemic heart disease. The main limitation of this study will be overcome in the second stage of the trial, where the specific role of each miRNA will be determined.",2020,"Concentrations of cardioprotective enzymes were higher in patients who received sevoflurane, as compared to patients who were administered propofol.
","['myocardial revascularization surgery', 'patients with ischemic heart disease', 'patients undergoing off-pump myocardial revascularization surgery']","['propofol', 'sevoflu-rane [S] or propofol [P', 'sevoflurane']","['Levels of cardioprotective enzymes (serine/threonine protein kinase (Akt), tumor necrosis fac-tor alpha (TNFα), extracellular regulated protein kinase (ERK 1/2), and caspase 3', 'Hemody-namics (heart rate, blood pressure, central venous pressure, cardiac index, systolic volume index, LVEF) and myocardial enzymes (troponin I', 'caspase and TnBF', 'Concentrations of cardioprotective enzymes']","[{'cui': 'C0027056', 'cui_str': 'Myocardial revascularization'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0151744', 'cui_str': 'Myocardial ischemia'}, {'cui': 'C0182537', 'cui_str': 'Pump'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0014442', 'cui_str': 'Enzyme'}, {'cui': 'C0072402', 'cui_str': 'Protein-Serine-Threonine Kinase'}, {'cui': 'C0333516', 'cui_str': 'Tumor necrosis'}, {'cui': 'C0054427', 'cui_str': 'CAF protocol'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0521119', 'cui_str': 'Extracellular'}, {'cui': 'C0851285', 'cui_str': 'Regulation'}, {'cui': 'C0033640', 'cui_str': 'Protein kinase'}, {'cui': 'C0752312', 'cui_str': 'Mitogen-Activated Protein Kinases'}, {'cui': 'C0580272', 'cui_str': '1/2'}, {'cui': 'C0291573', 'cui_str': 'Caspase-3'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0199666', 'cui_str': 'Measurement of central venous pressure'}, {'cui': 'C0428776', 'cui_str': 'Cardiac index'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0077401', 'cui_str': 'Troponin I'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.0602839,"Concentrations of cardioprotective enzymes were higher in patients who received sevoflurane, as compared to patients who were administered propofol.
","[{'ForeName': 'Jose Luis', 'Initials': 'JL', 'LastName': 'Guerrero Orriach', 'Affiliation': 'Department of Cardio-Anaesthesiology, University Hospital Virgen de la Victoria, Málaga, Spain.'}, {'ForeName': 'Juan Jose', 'Initials': 'JJ', 'LastName': 'Escalona Belmonte', 'Affiliation': 'Department of Cardio-Anaesthesiology, University Hospital Virgen de la Victoria, Málaga, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Ramirez Aliaga', 'Affiliation': 'Department of Cardio-Anaesthesiology, University Hospital Virgen de la Victoria, Málaga, Spain.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Ramirez Fernandez', 'Affiliation': 'Department of Cardio-Anaesthesiology, University Hospital Virgen de la Victoria, Málaga, Spain.'}, {'ForeName': 'Maria Jose', 'Initials': 'MJ', 'LastName': 'Rodriguez Capitan', 'Affiliation': 'Department of Cardio-Anaesthesiology, University Hospital Virgen de la Victoria, Málaga, Spain.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Quesada Muñoz', 'Affiliation': 'Department of Cardio-Anaesthesiology, University Hospital Virgen de la Victoria, Málaga, Spain.'}, {'ForeName': 'Aida', 'Initials': 'A', 'LastName': 'Raigón Ponferrada', 'Affiliation': 'Department of Cardio-Anaesthesiology, University Hospital Virgen de la Victoria, Málaga, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Alcaide Torres', 'Affiliation': 'Unidad de Gestión Clínica de Endocrinología y Nutrición, Hospital Universitario Virgen de la Victoria, Málaga, Spain.'}, {'ForeName': 'Concepcion', 'Initials': 'C', 'LastName': 'Santiago-Fernandez', 'Affiliation': 'Instituto de Investigacion Biomédica de Málaga (IBIMA), Málaga, Spain.'}, {'ForeName': 'Emilio', 'Initials': 'E', 'LastName': 'Matute Gonzalez', 'Affiliation': 'Department of Anesthesia, Hospital Universitario, Sanitas La Moraleja, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Rubio Navarro', 'Affiliation': 'Department of Cardio-Anaesthesiology, University Hospital Virgen de la Victoria, Málaga, Spain.'}, {'ForeName': 'Rocio', 'Initials': 'R', 'LastName': 'Bautista', 'Affiliation': 'Genómic and Ultrasecuenciation. Supercomputación y Bioinno-vación Center, Malaga University, Malaga, Spain.'}, {'ForeName': 'Josefa', 'Initials': 'J', 'LastName': 'Gómez Maldonado', 'Affiliation': 'Genómic and Ultrasecuenciation. Supercomputación y Bioinno-vación Center, Malaga University, Malaga, Spain.'}, {'ForeName': 'Lourdes', 'Initials': 'L', 'LastName': 'Garrido-Sanchez', 'Affiliation': 'Instituto de Investigacion Biomédica de Málaga (IBIMA), Málaga, Spain.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Cruz Mañas', 'Affiliation': 'Department of Cardio-Anaesthesiology, University Hospital Virgen de la Victoria, Málaga, Spain.'}]",Current medicinal chemistry,['10.2174/0929867327999201001202607']
3187,33025241,Biomechanical comparison of vertical suture techniques for repairing radial meniscus tear.,"PURPOSE


The aim of this study was to (1) develop suture techniques in repairing radial meniscal tear; (2) to compare the biomechanical properties of the proposed repair techniques with the conventional double horizontal technique.
METHODS


Thirty-six fresh-frozen porcine medial menisci were randomly assigned into four groups and a complete tear was made at the midline of each meniscus. The menisci were subsequently repaired using four different repair techniques: double vertical (DV), double vertical cross (DVX), hybrid composing one vertical and one horizontal stitch, and conventional double horizontal (DH) suture technique with suturing parallel to the tibia plateau. The conventional double horizontal group was the control. The repaired menisci were subjected to cyclic loading followed by the load to failure testing. Gap formation and strength were measured, stiffness was calculated, and mode of failure was recorded.
RESULTS


Group differences in gap formation were not statistically significant at 100 cycles (p = .42), 300 cycles (p = .68), and 500 cycles (p = .70). A trend was found toward higher load to failure in DVX (276.8 N, p < .001), DV (241.5 N, p < .001), and Hybrid (237.6 N, p < .001) compared with DH (148.5 N). Stiffness was also higher in DVX (60.7 N/mm, p < .001), DV (55.3 N/mm, p < .01), and Hybrid (52.1 N/mm, p < .01), than DH group (30.5 N/mm). Tissue failure was the only failure mode observed in all specimens.
CONCLUSION


Our two proposed vertical suture techniques, as well as the double vertical technique, had superior biomechanical properties than the conventional technique as demonstrated by higher stiffness and higher strength.",2020,"Stiffness was also higher in DVX (60.7 N/mm, p < .001), DV (55.3 N/mm, p < .01), and Hybrid (52.1 N/mm, p < .01), than DH group (30.5 N/mm).","['Thirty-six fresh-frozen porcine medial menisci', 'repairing radial meniscus tear']","['repair techniques: double vertical (DV), double vertical cross (DVX), hybrid composing one vertical and one horizontal stitch, and conventional double horizontal (DH) suture technique with suturing parallel to the tibia plateau', 'vertical suture techniques']","['Gap formation and strength', 'gap formation', 'Tissue failure', 'DVX', 'DV', 'higher load to failure in DVX']","[{'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0443224', 'cui_str': 'Fresh'}, {'cui': 'C0016701', 'cui_str': 'Freezing'}, {'cui': 'C0039005', 'cui_str': 'Suidae'}, {'cui': 'C0348073', 'cui_str': 'Medial meniscus structure'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C0238218', 'cui_str': 'Tear of meniscus of knee'}]","[{'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0038968', 'cui_str': 'Suturing techniques'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}]","[{'cui': 'C0061928', 'cui_str': 'GTPase-Activating Protein'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0205250', 'cui_str': 'High'}]",,0.0743292,"Stiffness was also higher in DVX (60.7 N/mm, p < .001), DV (55.3 N/mm, p < .01), and Hybrid (52.1 N/mm, p < .01), than DH group (30.5 N/mm).","[{'ForeName': 'Guanqi', 'Initials': 'G', 'LastName': 'Hang', 'Affiliation': 'Department of Orthopaedic Surgery, Singapore General Hospital, 20 College Road, Singapore, 169865, Singapore. hangguanqi@gmail.com.'}, {'ForeName': 'Andy Khye Soon', 'Initials': 'AKS', 'LastName': 'Yew', 'Affiliation': 'Department of Orthopaedic Surgery, Singapore General Hospital, 20 College Road, Singapore, 169865, Singapore.'}, {'ForeName': 'Siaw Meng', 'Initials': 'SM', 'LastName': 'Chou', 'Affiliation': 'School of Mechanical & Aerospace Engineering, College of Engineering, Nanyang Technological University, 50 Nanyang Ave, Singapore, 639798, Singapore.'}, {'ForeName': 'Yoke Rung', 'Initials': 'YR', 'LastName': 'Wong', 'Affiliation': 'Department of Hand Surgery, Singapore General Hospital, 20 College Road, Singapore, 169865, Singapore.'}, {'ForeName': 'Shian Chao', 'Initials': 'SC', 'LastName': 'Tay', 'Affiliation': 'Department of Hand Surgery, Singapore General Hospital, 20 College Road, Singapore, 169865, Singapore.'}, {'ForeName': 'Denny Tijauw Tjoen', 'Initials': 'DTT', 'LastName': 'Lie', 'Affiliation': 'Department of Orthopaedic Surgery, Singapore General Hospital, 20 College Road, Singapore, 169865, Singapore.'}]",Journal of experimental orthopaedics,['10.1186/s40634-020-00296-w']
3188,33030304,Circulating lipids in men with type 2 diabetes following 3 days on a carbohydrate-free diet versus 3 days of fasting.,"OBJECTIVE


We have been interested in determining the effects of dietary changes on fuel metabolism and regulation in men with type 2 diabetes mellitus (T2DM). In this study, the changes in 24-hr circulating lipid profiles were determined when the major fuel source was endogenous versus exogenous fat.
METHODS


Seven males with T2DM were randomized in a crossover design with a 4-week washout period. A standard mixed (control) diet (30%fat:15%protein:55%carbohydrate) was provided initially. Subsequently, a 72-hr (3-day) fast, or a high fat (85%), 15% protein, essentially carbohydrate-free (CHO-free) diet was provided for 72 hr. Triacylglycerol (TAG), non-esterified fatty acids (NEFA), β-hydroxybutyrate (bHB), and insulin-like growth factor-binding protein-1 (IGFBP-1) profiles were determined during the last 24 hr of intervention, as well as during the control diet.
RESULTS


Regardless of the amount of dietary fat (30% vs 85%) and differences in 24-hr profiles, TAG, NEFA, and bHB all returned to the previous basal concentrations within 24 hr. TAGs and NEFAs changed only modestly with fasting; bHB was elevated and increasing. The IGFBP-1 profile was essentially unchanged with either diet but increased with fasting.
CONCLUSION


A CHO-free diet resulted in a large increase in TAG and NEFA versus the control diet; however, both were cleared by the following morning. A negative NEFA profile occurred with the control diet. Thus, mechanisms are present to restore lipid concentrations to their original AM concentrations daily. Fasting resulted in stable concentrations, except for a continuing increase in bHB. Glucose and insulin, common fuel regulators, could not explain the results.",2020,"A CHO-free diet resulted in a large increase in TAG and NEFA versus the control diet; however, both were cleared by the following morning.","['men with type 2 diabetes', 'Seven males with T2DM', 'men with type 2 diabetes mellitus (T2DM']","['standard mixed (control) diet (30%fat:15%protein:55%carbohydrate', 'carbohydrate-free diet']","['Triacylglycerol (TAG), non-esterified fatty acids', 'Circulating lipids', '24-hr circulating lipid profiles', '24-hr profiles, TAG, NEFA, and bHB', 'IGFBP-1 profile', 'NEFA), β-hydroxybutyrate (bHB), and insulin-like growth factor-binding protein-1', 'bHB']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0452308', 'cui_str': 'Carbohydrate-free diet'}]","[{'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0369212', 'cui_str': 'Esterified fatty acid'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0071189', 'cui_str': 'IGFBP1 protein, human'}, {'cui': 'C0020332', 'cui_str': 'Hydroxybutyrates'}]",7.0,0.013052,"A CHO-free diet resulted in a large increase in TAG and NEFA versus the control diet; however, both were cleared by the following morning.","[{'ForeName': 'Frank Q', 'Initials': 'FQ', 'LastName': 'Nuttall', 'Affiliation': 'Section of Endocrinology, Metabolism & Nutrition, and the Metabolic Research Laboratory, Minneapolis VA Health Care System, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Rami M', 'Initials': 'RM', 'LastName': 'Almokayyad', 'Affiliation': 'Section of Endocrinology, Metabolism & Nutrition, and the Metabolic Research Laboratory, Minneapolis VA Health Care System, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Mary C', 'Initials': 'MC', 'LastName': 'Gannon', 'Affiliation': 'Section of Endocrinology, Metabolism & Nutrition, and the Metabolic Research Laboratory, Minneapolis VA Health Care System, University of Minnesota, Minneapolis, MN, USA.'}]",Physiological reports,['10.14814/phy2.14569']
3189,33030312,Responding to the ECHO trial results: modelling the potential impact of changing contraceptive method mix on HIV and reproductive health in South Africa.,"INTRODUCTION


Some observational data suggest that the progestogen injectable contraceptive depot medroxyprogesterone acetate (DMPA) may increase a woman's risk of HIV acquisition but a randomized clinical trial did not find a statistically significant increase in HIV risk for women using DMPA compared to two other methods. However, it could not rule out up to 30% increased HIV risk for DMPA users. We evaluate changes to contraceptive method mix in South Africa under different assumptions about the existence and strength of a possible undetected relationship between DMPA use and HIV risk.
METHODS


A mathematical model was developed to simulate the ongoing HIV epidemic and contraceptive method mix in South Africa to estimate how changes in method mix could impact HIV- and reproductive health-related outcomes. We made different assumptions about the relationship between DMPA use and HIV risk, from no relationship to a 30% increase in HIV risk for women using DMPA. Scenario analyses were used to investigate the impact of switching away from DMPA predominance to new patterns of contraceptive use.
RESULTS


In South Africa, the HIV-related benefits of reduced DMPA use could be as great as the harms of increased adverse reproductive health outcomes over 20 years, if DMPA did increase the risk of HIV acquisition by a relative hazard of infection of 1.1 or greater. A reduction in DMPA use among HIV-positive women would have no benefit in terms of HIV infections, but would incur additional negative reproductive health outcomes. The most important driver of adverse reproductive health outcomes is the proportion of women who switch away from DMPA to no contraceptive method.
CONCLUSIONS


If there is any real increased HIV risk for DMPA users that has not been detected by the recent randomized trial, a reduction in DMPA use could reduce the ongoing number of new HIV infections. However, such a change would place more women at risk of adverse reproductive health effects. It is imperative that these effects are minimized by focusing on expanding access to safe, effective and acceptable alternative contraceptive methods for all women.",2020,"A reduction in DMPA use among HIV-positive women would have no benefit in terms of HIV infections, but would incur additional negative reproductive health outcomes.","['women who switch away from DMPA to no contraceptive method', 'HIV and reproductive health in South Africa']",['progestogen injectable contraceptive depot medroxyprogesterone acetate (DMPA'],"['HIV risk', 'risk of HIV acquisition']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0065864', 'cui_str': 'Medroxyprogesterone acetate'}, {'cui': 'C0700589', 'cui_str': 'Contraception'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0242667', 'cui_str': 'Reproductive Health'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}]","[{'cui': 'C0033306', 'cui_str': 'Progestational hormone'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C0065864', 'cui_str': 'Medroxyprogesterone acetate'}]","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",,0.260324,"A reduction in DMPA use among HIV-positive women would have no benefit in terms of HIV infections, but would incur additional negative reproductive health outcomes.","[{'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Smith', 'Affiliation': 'MRC Centre for Global Infectious Disease Analysis, Department of Infectious Disease Epidemiology, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'Beacroft', 'Affiliation': 'MRC Centre for Global Infectious Disease Analysis, Department of Infectious Disease Epidemiology, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Fareed', 'Initials': 'F', 'LastName': 'Abdullah', 'Affiliation': 'Office of AIDS and TB Research, South African Medical Research Council, Pretoria, South Africa.'}, {'ForeName': 'Buyile', 'Initials': 'B', 'LastName': 'Buthelezi', 'Affiliation': 'USAID, Pretoria, South Africa.'}, {'ForeName': 'Manala', 'Initials': 'M', 'LastName': 'Makua', 'Affiliation': 'National Department of Health, Pretoria, South Africa.'}, {'ForeName': 'Chelsea', 'Initials': 'C', 'LastName': 'Morroni', 'Affiliation': 'Botswana Harvard AIDS Institute, Gaborone, Botswana.'}, {'ForeName': 'Gita', 'Initials': 'G', 'LastName': 'Ramjee', 'Affiliation': 'Aurum Institute, Parktown, South Africa.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Velasquez', 'Affiliation': 'UNAIDS Eastern and Southern Africa, Johannesburg, South Africa.'}, {'ForeName': 'Timothy B', 'Initials': 'TB', 'LastName': 'Hallett', 'Affiliation': 'MRC Centre for Global Infectious Disease Analysis, Department of Infectious Disease Epidemiology, Imperial College London, London, United Kingdom.'}]",Journal of the International AIDS Society,['10.1002/jia2.25620']
3190,33030349,Comparison of the Effect of Kinesio Taping and Manual Lymphatic Drainage on Breast Engorgement in Postpartum Women: A Randomized-Controlled Trial.,"Objectives:  To investigate the effect of kinesio taping (KT) and manual lymphatic drainage (MLD) on pain severity, breast engorgement, and milk volume in postpartum women.  Materials and Methods:  In this prospective randomized-controlled trial, we recruited 67 postpartum women who had breast engorgement and randomly assigned them to the KT, MLD, and control group. In the KT group, taping plus breast care was performed, MLD plus breast care was performed in the MLD group, and in the control group, only routine breast care was given for 10 days. Pain, breast engorgement, body temperature, and milk volume were measured. Examinations were repeated on days 1, 4, and 10.  Results:  The MLD group had significant reductions in pain and breast engorgement at all postintervention days compared with the control and KT group ( p  < 0.05). Milk volume increased among three groups, but the change in the MLD group was higher than in the KT and control groups ( p  < 0.05). There was no significant difference in the milk volume among the KT and control groups at all postintervention days ( p  > 0.05).  Conclusions:  MLD relieved breast pain and firmness more and increased milk volume in postpartum women compared with the KT and control groups. MLD can be recommended to postnatal mothers to better manage breast engorgement.",2020,The MLD group had significant reductions in pain and breast engorgement at all postintervention days compared with the control and KT group ( p  < 0.05).,"['Postpartum Women', '67 postpartum women who had breast engorgement and randomly assigned them to the KT, MLD, and control group', 'postpartum women']","['kinesio taping (KT) and manual lymphatic drainage (MLD', 'MLD', 'Kinesio Taping and Manual Lymphatic Drainage']","['milk volume', 'pain and breast engorgement', 'pain severity, breast engorgement, and milk volume', 'Pain, breast engorgement, body temperature, and milk volume', 'Milk volume']","[{'cui': 'C0032804', 'cui_str': 'Postpartum Women'}, {'cui': 'C0085688', 'cui_str': 'Engorgement of breasts'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0023522', 'cui_str': 'Metachromatic leukodystrophy'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0556834', 'cui_str': 'Manual lymphatic drainage'}, {'cui': 'C0023522', 'cui_str': 'Metachromatic leukodystrophy'}]","[{'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0085688', 'cui_str': 'Engorgement of breasts'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}]",67.0,0.0503833,The MLD group had significant reductions in pain and breast engorgement at all postintervention days compared with the control and KT group ( p  < 0.05).,"[{'ForeName': 'Hanife', 'Initials': 'H', 'LastName': 'Doğan', 'Affiliation': 'Sarıkaya School of Physiotherapy and Rehabilitation, Yozgat Bozok University, Yozgat, Turkey.'}, {'ForeName': 'Semra', 'Initials': 'S', 'LastName': 'Eroğlu', 'Affiliation': 'Department of Gynecology and Obstetrics, Educational and Research Hospital, Başkent University, Konya, Turkey.'}, {'ForeName': 'Türkan', 'Initials': 'T', 'LastName': 'Akbayrak', 'Affiliation': 'Faculty of Physical Therapy and Rehabilitation, Hacettepe University, Ankara, Turkey.'}]",Breastfeeding medicine : the official journal of the Academy of Breastfeeding Medicine,['10.1089/bfm.2020.0115']
3191,33027246,The impact of continuous quality improvement on coverage of antenatal HIV care tests in rural South Africa: Results of a stepped-wedge cluster-randomised controlled implementation trial.,"BACKGROUND


Evidence for the effectiveness of continuous quality improvement (CQI) in resource-poor settings is very limited. We aimed to establish the effects of CQI on quality of antenatal HIV care in primary care clinics in rural South Africa.
METHODS AND FINDINGS


We conducted a stepped-wedge cluster-randomised controlled trial (RCT) comparing CQI to usual standard of antenatal care (ANC) in 7 nurse-led, public-sector primary care clinics-combined into 6 clusters-over 8 steps and 19 months. Clusters randomly switched from comparator to intervention on pre-specified dates until all had rolled over to the CQI intervention. Investigators and clusters were blinded to randomisation until 2 weeks prior to each step. The intervention was delivered by trained CQI mentors and included standard CQI tools (process maps, fishbone diagrams, run charts, Plan-Do-Study-Act [PDSA] cycles, and action learning sessions). CQI mentors worked with health workers, including nurses and HIV lay counsellors. The mentors used the standard CQI tools flexibly, tailored to local clinic needs. Health workers were the direct recipients of the intervention, whereas the ultimate beneficiaries were pregnant women attending ANC. Our 2 registered primary endpoints were viral load (VL) monitoring (which is critical for elimination of mother-to-child transmission of HIV [eMTCT] and the health of pregnant women living with HIV) and repeat HIV testing (which is necessary to identify and treat women who seroconvert during pregnancy). All pregnant women who attended their first antenatal visit at one of the 7 study clinics and were ≥18 years old at delivery were eligible for endpoint assessment. We performed intention-to-treat (ITT) analyses using modified Poisson generalised linear mixed effects models. We estimated effect sizes with time-step fixed effects and clinic random effects (Model 1). In separate models, we added a nested random clinic-time step interaction term (Model 2) or individual random effects (Model 3). Between 15 July 2015 and 30 January 2017, 2,160 participants with 13,212 ANC visits (intervention n = 6,877, control n = 6,335) were eligible for ITT analysis. No adverse events were reported. Median age at first booking was 25 years (interquartile range [IQR] 21 to 30), and median parity was 1 (IQR 0 to 2). HIV prevalence was 47% (95% CI 42% to 53%). In Model 1, CQI significantly increased VL monitoring (relative risk [RR] 1.38, 95% CI 1.21 to 1.57, p < 0.001) but did not improve repeat HIV testing (RR 1.00, 95% CI 0.88 to 1.13, p = 0.958). These results remained essentially the same in both Model 2 and Model 3. Limitations of our study include that we did not establish impact beyond the duration of the relatively short study period of 19 months, and that transition steps may have been too short to achieve the full potential impact of the CQI intervention.
CONCLUSIONS


We found that CQI can be effective at increasing quality of primary care in rural Africa. Policy makers should consider CQI as a routine intervention to boost quality of primary care in rural African communities. Implementation research should accompany future CQI use to elucidate mechanisms of action and to identify factors supporting long-term success.
TRIAL REGISTRATION


This trial is registered at ClinicalTrials.gov under registration number NCT02626351.",2020,"In Model 1, CQI significantly increased VL monitoring (relative risk [RR] 1.38, 95% CI 1.21 to 1.57, p < 0.001) but did not improve repeat HIV testing (RR 1.00, 95% CI 0.88 to 1.13, p = 0.958).","['primary care clinics in rural South Africa', '7 nurse-led, public-sector primary care clinics-combined into 6 clusters-over 8 steps and 19 months', 'All pregnant women who attended their first antenatal visit at one of the 7 study clinics and were ≥18 years old at delivery were eligible for endpoint assessment', 'rural South Africa', 'Between 15 July 2015 and 30 January 2017, 2,160 participants with 13,212 ANC visits (intervention n = 6,877, control n = 6,335) were eligible for ITT analysis', 'rural African communities']","['CQI to usual standard of antenatal care (ANC', 'CQI', 'trained CQI mentors and included standard CQI tools (process maps, fishbone diagrams, run charts, Plan-Do-Study-Act [PDSA] cycles, and action learning sessions']","['coverage of antenatal HIV care tests', 'adverse events', 'quality of antenatal HIV care', 'repeat HIV testing', 'HIV prevalence', 'VL monitoring', 'viral load (VL) monitoring']","[{'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0034035', 'cui_str': 'Public Sector'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C2936612', 'cui_str': 'Quality Improvement'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0025369', 'cui_str': 'Mentors'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0024779', 'cui_str': 'Maps'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0684240', 'cui_str': 'Chart'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0459958', 'cui_str': 'HIV screening'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}]",2160.0,0.110171,"In Model 1, CQI significantly increased VL monitoring (relative risk [RR] 1.38, 95% CI 1.21 to 1.57, p < 0.001) but did not improve repeat HIV testing (RR 1.00, 95% CI 0.88 to 1.13, p = 0.958).","[{'ForeName': 'H Manisha', 'Initials': 'HM', 'LastName': 'Yapa', 'Affiliation': 'The Kirby Institute, University of New South Wales Sydney, NSW, Australia.'}, {'ForeName': 'Jan-Walter', 'Initials': 'JW', 'LastName': 'De Neve', 'Affiliation': 'Heidelberg Institute of Global Health (HIGH), Medical Faculty and University Hospital, Heidelberg University, Heidelberg, Germany.'}, {'ForeName': 'Terusha', 'Initials': 'T', 'LastName': 'Chetty', 'Affiliation': 'Health systems Research Unit, South African Medical Research Council, Durban, South Africa.'}, {'ForeName': 'Carina', 'Initials': 'C', 'LastName': 'Herbst', 'Affiliation': 'Africa Health Research Institute (AHRI), KwaZulu-Natal, South Africa.'}, {'ForeName': 'Frank A', 'Initials': 'FA', 'LastName': 'Post', 'Affiliation': ""King's College Hospital NHS Foundation Trust, London, United Kingdom.""}, {'ForeName': 'Awachana', 'Initials': 'A', 'LastName': 'Jiamsakul', 'Affiliation': 'The Kirby Institute, University of New South Wales Sydney, NSW, Australia.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Geldsetzer', 'Affiliation': 'Heidelberg Institute of Global Health (HIGH), Medical Faculty and University Hospital, Heidelberg University, Heidelberg, Germany.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Harling', 'Affiliation': 'Africa Health Research Institute (AHRI), KwaZulu-Natal, South Africa.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Dhlomo-Mphatswe', 'Affiliation': 'School of Clinical Medicine, Discipline of Obstetrics and Gynaecology, University of KwaZulu-Natal, Durban, South Africa.'}, {'ForeName': 'Mosa', 'Initials': 'M', 'LastName': 'Moshabela', 'Affiliation': 'Africa Health Research Institute (AHRI), KwaZulu-Natal, South Africa.'}, {'ForeName': 'Philippa', 'Initials': 'P', 'LastName': 'Matthews', 'Affiliation': 'Africa Health Research Institute (AHRI), KwaZulu-Natal, South Africa.'}, {'ForeName': 'Osondu', 'Initials': 'O', 'LastName': 'Ogbuoji', 'Affiliation': 'Global Health Institute, Duke University, Durham, North Carolina, United States of America.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Tanser', 'Affiliation': 'Africa Health Research Institute (AHRI), KwaZulu-Natal, South Africa.'}, {'ForeName': 'Dickman', 'Initials': 'D', 'LastName': 'Gareta', 'Affiliation': 'Africa Health Research Institute (AHRI), KwaZulu-Natal, South Africa.'}, {'ForeName': 'Kobus', 'Initials': 'K', 'LastName': 'Herbst', 'Affiliation': 'Africa Health Research Institute (AHRI), KwaZulu-Natal, South Africa.'}, {'ForeName': 'Deenan', 'Initials': 'D', 'LastName': 'Pillay', 'Affiliation': 'Africa Health Research Institute (AHRI), KwaZulu-Natal, South Africa.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Wyke', 'Affiliation': 'Africa Health Research Institute (AHRI), KwaZulu-Natal, South Africa.'}, {'ForeName': 'Till', 'Initials': 'T', 'LastName': 'Bärnighausen', 'Affiliation': 'Africa Health Research Institute (AHRI), KwaZulu-Natal, South Africa.'}]",PLoS medicine,['10.1371/journal.pmed.1003150']
3192,33027267,The role of health education on cervical cancer screening uptake at selected health centers in Addis Ababa.,"INTRODUCTION


Cervical cancer is one of the most common causes of morbidity and mortality among women in developing countries including Ethiopia. Unlike other types of cancers, the grave outcomes of cervical cancer could be prevented if detected at its early stage. However, in Ethiopia, awareness about the disease and the availability of screening and treatment services is limited. This study aims to determine the role of health education on cervical cancer screening uptake in selected health facilities in Addis Ababa.
METHODS


Two-pronged clustered randomized controlled trial was conducted in 2018 at eight public health centers that provide cervical cancer screening services using visual inspection with acetic acid (VIA) in Addis Ababa, Ethiopia. Each of the eight health centers were randomly assigned to serve as either an intervention or a control center. A two-pronged clustered randomized controlled trial was conducted in eight public health care centers. All the selected facilities provided cervical cancer screening services using visual inspection with acetic acid (VIA). Four health centers were randomly assigned to the intervention and control arms. The study participants were women aged 30-49 years who sought care at maternal and child health clinics but who had never been screened for cervical cancer. In the intervention health centers, all eligible women received one-to-one health education and educational brochures about cervical cancer and cervical cancer screening. In the control health centers, participants received standard care. Baseline data were collected at recruitment and follow-up data were collected two months after the baseline. For the follow-up data collection, participants (both in the intervention and control arms) were interviewed over the phone to check whether they were screened for cervical cancer.
RESULT


From the 2,140 women who participated in the study, 215 (10%) screened for cervical cancer, where 152(71%) were from the intervention health centers. Seventy-four percent of these participants reported that they learned about the benefits of screening from the one-to-one health education or the brochure. Women from the intervention health centers had higher odds of getting screened (AOR = 2.43,95%CI;1.58-2.90) than the controls. Women with the educational status of the first degree and those who have a history of sexually transmitted infections (STIs) had higher odds of getting screened (AOR = 2.03,95%CI;(1.15-2.58) and (AOR = 1.55,95%CI;1.01-2.36), respectively.
CONCLUSION AND RECOMMENDATION


Providing focused health education supported by printed educational materials increased the uptake of cervical cancer screening services. Integrating one-to-one health education and providing a take-home educational material into the existing maternal and child health services can help increase cervical cancer screening uptake.",2020,"Women from the intervention health centers had higher odds of getting screened (AOR = 2.43,95%CI;1.58-2.90) than the controls.","['Four health centers', 'women in developing countries including Ethiopia', 'participants were women aged 30-49 years who sought care at maternal and child health clinics but who had never been screened for cervical cancer', 'eight public health care centers', '2,140 women who participated in the study, 215 (10%) screened for cervical cancer, where 152(71%) were from the intervention health centers', 'cervical cancer screening uptake at selected health centers in Addis Ababa', 'eight health centers', 'Two-pronged clustered randomized controlled trial was conducted in 2018 at eight public health centers that provide cervical cancer screening services using visual inspection with acetic acid (VIA) in Addis Ababa, Ethiopia', 'selected health facilities in Addis Ababa']","['health education', 'one-to-one health education and educational brochures about cervical cancer and cervical cancer screening', 'visual inspection with acetic acid (VIA']",[],"[{'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011750', 'cui_str': 'Less-Developed Countries'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0015024', 'cui_str': 'Ethiopia'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0008078', 'cui_str': 'Child health care'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4709308', 'cui_str': '215'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0199219', 'cui_str': 'Inspection'}, {'cui': 'C0000983', 'cui_str': 'Acetic Acid'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C4505266', 'cui_str': 'One Health Concept'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0199219', 'cui_str': 'Inspection'}, {'cui': 'C0000983', 'cui_str': 'Acetic Acid'}]",[],2140.0,0.136285,"Women from the intervention health centers had higher odds of getting screened (AOR = 2.43,95%CI;1.58-2.90) than the controls.","[{'ForeName': 'Selamawit Hirpa', 'Initials': 'SH', 'LastName': 'Abu', 'Affiliation': 'School of Public Health, College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia.'}, {'ForeName': 'Berhan Tassew', 'Initials': 'BT', 'LastName': 'Woldehanna', 'Affiliation': 'School of Public Health, College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia.'}, {'ForeName': 'Etsehiwot Tilahun', 'Initials': 'ET', 'LastName': 'Nida', 'Affiliation': 'School of Public Health, College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia.'}, {'ForeName': 'Abigiya Wondimagegnehu', 'Initials': 'AW', 'LastName': 'Tilahun', 'Affiliation': 'School of Public Health, College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia.'}, {'ForeName': 'Mahlet Yigeremu', 'Initials': 'MY', 'LastName': 'Gebremariam', 'Affiliation': 'School of Medicine, College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia.'}, {'ForeName': 'Mitike Molla', 'Initials': 'MM', 'LastName': 'Sisay', 'Affiliation': 'School of Public Health, College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia.'}]",PloS one,['10.1371/journal.pone.0239580']
3193,33029128,No Effect of Anodal tDCS on Verbal Episodic Memory Performance and Neurotransmitter Levels in Young and Elderly Participants.,"Healthy ageing is accompanied by cognitive decline that affects episodic memory processes in particular. Studies showed that anodal transcranial direct current stimulation (tDCS) to the left dorsolateral prefrontal cortex (DLPFC) may counteract this cognitive deterioration by increasing excitability and inducing neuroplasticity in the targeted cortical region. While stimulation gains are more consistent in initial low performers, relying solely on behavioural measures to predict treatment benefits does not suffice for a reliable implementation of this method as a therapeutic option. Hence, an exploration of the underlying neurophysiological mechanisms regarding the differential stimulation effect is warranted. Glutamatergic metabolites (Glx) and  γ -aminobutyric acid (GABA) are involved in learning and memory processes and can be influenced with tDCS; wherefore, they present themselves as potential biomarkers for tDCS-induced behavioural gains, which are affiliated with neuroplasticity processes. In the present randomized, double-blind, sham-controlled, crossover study, 33 healthy young and 22 elderly participants received anodal tDCS to their left DLPFC during the encoding phase of a verbal episodic memory task. Using MEGA-PRESS edited magnetic resonance spectroscopy (MRS), Glx and GABA levels were measured in the left DLPFC before and after the stimulation period. Further, we tested whether baseline performance and neurotransmitter levels predicted subsequent gains. No beneficial group effects of tDCS emerged in either verbal retrieval performances or neurotransmitter concentrations. Moreover, baseline performance levels did not predict stimulation-induced cognitive gains, nor did Glx or GABA levels. Nevertheless, exploratory analyses suggested a predictive value of the Glx : GABA ratio, with lower ratios at baseline indicating greater tDCS-related gains in delayed recall performance. This highlights the importance of further studies investigating neurophysiological mechanisms underlying previously observed stimulation-induced cognitive benefits and their respective interindividual heterogeneity.",2020,No beneficial group effects of tDCS emerged in either verbal retrieval performances or neurotransmitter concentrations.,"['33 healthy young and 22 elderly participants', 'Young and Elderly Participants']","['Anodal tDCS', 'anodal tDCS to their left DLPFC during the encoding phase of a verbal episodic memory task', 'Glutamatergic metabolites (Glx) and  γ -aminobutyric acid (GABA', 'anodal transcranial direct current stimulation (tDCS', 'tDCS']","['verbal retrieval performances or neurotransmitter concentrations', 'magnetic resonance spectroscopy (MRS), Glx and GABA levels', 'cognitive gains, nor did Glx or GABA levels', 'delayed recall performance', 'Verbal Episodic Memory Performance and Neurotransmitter Levels']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0347984', 'cui_str': 'During'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0561843', 'cui_str': 'Episodic memory'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0016904', 'cui_str': 'Gamma-aminobutyric acid'}]","[{'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0027908', 'cui_str': 'Neurotransmitter'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0024487', 'cui_str': 'Magnetic resonance spectroscopy'}, {'cui': 'C0016904', 'cui_str': 'Gamma-aminobutyric acid'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0561843', 'cui_str': 'Episodic memory'}]",33.0,0.065342,No beneficial group effects of tDCS emerged in either verbal retrieval performances or neurotransmitter concentrations.,"[{'ForeName': 'Annegret', 'Initials': 'A', 'LastName': 'Habich', 'Affiliation': 'University Hospital of Old Age Psychiatry and Psychotherapy, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Slotboom', 'Affiliation': 'Support Center for Advanced Neuroimaging (SCAN), Neuroradiology, University Hospital of Bern, Inselspital, Bern, Switzerland.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Peter', 'Affiliation': 'University Hospital of Old Age Psychiatry and Psychotherapy, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Wiest', 'Affiliation': 'Institute of Diagnostic and Interventional Neuroradiology, University Hospital of Bern, Inselspital, Bern, Switzerland.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Klöppel', 'Affiliation': 'University Hospital of Old Age Psychiatry and Psychotherapy, University of Bern, Bern, Switzerland.'}]",Neural plasticity,['10.1155/2020/8896791']
3194,33032485,Long-Term Results After Drug-Eluting Versus Bare-Metal Stent Implantation in Saphenous Vein Grafts: Randomized Controlled Trial.,"Background Efficacy data on drug-eluting stents (DES) versus bare-metal stents (BMS) in saphenous vein grafts are controversial. We aimed to compare DES with BMS among patients undergoing saphenous vein grafts intervention regarding long-term outcome. Methods and Results In this multinational trial, patients were randomized to paclitaxel-eluting or BMS. The primary end point was major adverse cardiac events (cardiac death, nonfatal myocardial infarction, and target-vessel revascularization at 1 year. Secondary end points included major adverse cardiac events and its individual components at 5-year follow-up. One hundred seventy-three patients were included in the trial (89 DES versus 84 BMS). One-year major adverse cardiac event rates were lower in DES compared with BMS (2.2% versus 16.0%, hazard ratio, 0.14; 95% CI, 0.03-0.64,  P =0.01), which was mainly driven by a reduction of subsequent myocardial infarctions and need for target-vessel revascularization. Five-year major adverse cardiac event rates remained lower in the DES compared with the BMS arm (35.5% versus 56.1%, hazard ratio, 0.40; 95% CI, 0.23-0.68,  P <0.001). A landmark-analysis from 1 to 5 years revealed a persistent benefit of DES over BMS (hazard ratio, 0.33; 95% CI, 0.13-0.74,  P =0.007) in terms of target-vessel revascularization. More patients in the BMS group underwent multiple target-vessel revascularization procedures throughout the study period compared with the DES group (DES 1.1% [n=1] versus BMS 9.5% [n=8],  P =0.013). Enrollment was stopped before the target sample size of 240 patients was reached. Conclusions In this randomized controlled trial with prospective long-term follow-up of up to 5 years, DES showed a better efficacy than BMS with sustained benefits over time. DES may be the preferred strategy in this patient population. Registration URL: https://www.clini​caltr​ials.gov; Unique identifier: NCT00595647.",2020,"More patients in the BMS group underwent multiple target-vessel revascularization procedures throughout the study period compared with the DES group (DES 1.1% [n=1] versus BMS 9.5% [n=8],  P =0.013).","['One hundred seventy-three patients were included in the trial (89 DES versus 84 BMS', 'patients undergoing saphenous vein grafts intervention regarding long-term outcome', 'Saphenous Vein Grafts']","['drug-eluting stents (DES) versus bare-metal stents (BMS', 'BMS', 'Registration URL', 'Drug-Eluting Versus Bare-Metal Stent Implantation', 'DES', 'paclitaxel-eluting or BMS', 'DES with BMS']","['major adverse cardiac events (cardiac death, nonfatal myocardial infarction, and target-vessel revascularization at 1\xa0year', 'major adverse cardiac events and its individual components at 5-year follow-up', 'adverse cardiac event rates', 'subsequent myocardial infarctions and need for target-vessel revascularization']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0729538', 'cui_str': 'Saphenous vein graft'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}]","[{'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}, {'cui': 'C2825200', 'cui_str': 'Bare metal stent'}, {'cui': 'C3541384', 'cui_str': 'URL'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0011702', 'cui_str': '4-(4-Amino-4-Carboxybutyl)-1-(5-Amino-5-Carboxypentyl)-3,5-bis(3-Amino-3-Carboxypropyl)pyridinium'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0449618', 'cui_str': 'Target vessel'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0348593', 'cui_str': 'Subsequent myocardial infarction'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}]",173.0,0.226873,"More patients in the BMS group underwent multiple target-vessel revascularization procedures throughout the study period compared with the DES group (DES 1.1% [n=1] versus BMS 9.5% [n=8],  P =0.013).","[{'ForeName': 'Gregor', 'Initials': 'G', 'LastName': 'Fahrni', 'Affiliation': 'University Hospital Basel Switzerland.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Farah', 'Affiliation': 'Klinikum Westfalen Dortmund Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Engstrøm', 'Affiliation': 'Rigshospitalet Copenhagen Denmark.'}, {'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Galatius', 'Affiliation': 'Bispebjerg University Hospital Copenhagen Denmark.'}, {'ForeName': 'Franz', 'Initials': 'F', 'LastName': 'Eberli', 'Affiliation': 'Triemli Hospital Zürich Switzerland.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Rickenbacher', 'Affiliation': 'University Hospital Basel Switzerland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Conen', 'Affiliation': 'University Hospital Basel Switzerland.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Mueller', 'Affiliation': 'University Hospital Basel Switzerland.'}, {'ForeName': 'Otmar', 'Initials': 'O', 'LastName': 'Pfister', 'Affiliation': 'University Hospital Basel Switzerland.'}, {'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Twerenbold', 'Affiliation': 'University Hospital Basel Switzerland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Coslovsky', 'Affiliation': 'University Hospital Basel Switzerland.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Cattaneo', 'Affiliation': 'University Hospital Basel Switzerland.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Kaiser', 'Affiliation': 'University Hospital Basel Switzerland.'}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Mangner', 'Affiliation': 'Herzzentrum Dresden Technische Universität Dresden Dresden Germany.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Schuler', 'Affiliation': 'Heart Center University of Leipzig Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Pfisterer', 'Affiliation': 'University Hospital Basel Switzerland.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Möbius-Winkler', 'Affiliation': 'Heart Center University of Leipzig Germany.'}, {'ForeName': 'Raban V', 'Initials': 'RV', 'LastName': 'Jeger', 'Affiliation': 'University Hospital Basel Switzerland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American Heart Association,['10.1161/JAHA.120.017434']
3195,33033007,Evaluating spillover of HIV knowledge from study participants to their network members in a stepped-wedge behavioural intervention in Tanzania.,"OBJECTIVES


We aim to describe the social network members of participants of a behavioural intervention, and examine how the effects of the intervention may spillover among network members.
DESIGN


Secondary analysis of a step-wedge randomised controlled trial.
SETTING


Change agents (CAs) were recruited from waiting rooms of HIV treatment facilities in Dar es Salaam, Tanzania, and their network members (NMs) were recruited directly by CAs.
PARTICIPANTS


We enrolled 662 CAs in an HIV behavioural intervention. They, along with 710 of their NMs, completed baseline and follow-up interviews from 2011 to 2013.
PRIMARY AND SECONDARY OUTCOMES


The primary outcome of this study was change in NMs' HIV knowledge, and the secondary outcome was whether the NM was lost to follow-up.
RESULTS


At baseline, many characteristics were different between NMs and CAs. We found a number of NM characteristics significantly associated with follow-up of NMs, particularly female gender (OR=1.64, 95% CI: 1.02 to 2.63) and HIV knowledge (OR=20.0, 95% CI: 3.70 to 125); only one CA variable was significantly associated with NM follow-up: having a private source of water (OR=2.17, 95% CI: 1.33 to 3.57). The 14.2% increase in NMs' HIV knowledge was largely due to CAs feeling empowered to pass on prior knowledge, rather than transmitting new knowledge to their NMs.
CONCLUSIONS


Characteristics of social network members of persons living with HIV persons living with HIV may play a role in study retention. Additionally, the HIV knowledge of these NMs increased largely as a function of CA participation in the intervention, suggesting that intervening among highly-connected individuals may maximise benefits to the potential population for whom spillover can occur.
TRIAL REGISTRATION NUMBER


Clinical Trial: NCT01693458; Post-results.",2020,"The 14.2% increase in NMs' HIV knowledge was largely due to CAs feeling empowered to pass on prior knowledge, rather than transmitting new knowledge to their NMs.
","['study participants to their network members in a stepped-wedge behavioural intervention in Tanzania', 'Change agents (CAs) were recruited from waiting rooms of HIV treatment facilities in Dar es Salaam, Tanzania, and their network members (NMs) were recruited directly by CAs', 'persons living with HIV persons living with HIV', 'social network members of participants of a', 'We enrolled 662 CAs in an HIV behavioural intervention']",['behavioural intervention'],"[""change in NMs' HIV knowledge"", 'HIV knowledge', 'number of NM characteristics', ""NMs' HIV knowledge""]","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0439639', 'cui_str': 'Wedge'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0022595', 'cui_str': 'Darier disease'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",662.0,0.189079,"The 14.2% increase in NMs' HIV knowledge was largely due to CAs feeling empowered to pass on prior knowledge, rather than transmitting new knowledge to their NMs.
","[{'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Rewley', 'Affiliation': 'Center for Health Care Innovation, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA jeffrey.rewley@pennmedicine.upenn.edu.'}, {'ForeName': 'Mary C Smith', 'Initials': 'MCS', 'LastName': 'Fawzi', 'Affiliation': 'Global Health and Social Medicine, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'McAdam', 'Affiliation': 'Epidemiology, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Kaaya', 'Affiliation': 'School of Medicine, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'University of Texas School of Public Health, Austin, Texas, USA.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Todd', 'Affiliation': 'Population Health, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Andrew', 'Affiliation': 'Management and Development for Health, Dar es Salaam, Tanzania.'}, {'ForeName': 'Jukka Pekka', 'Initials': 'JP', 'LastName': 'Onnela', 'Affiliation': 'Biostatistics, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.'}]",BMJ open,['10.1136/bmjopen-2019-033759']
3196,33033011,Comparison of PGS2.0 versus conventional embryo morphology evaluation for patients with recurrent pregnancy loss: a study protocol for a multicentre randomised trial.,"INTRODUCTION


Pregnancy loss (PL) is an adverse life event, and there is no proven effective treatment for recurrent PL (RPL). Preimplantation genetic screening (PGS) can be performed to reduce the risks of PL; however, there is still no solid scientific evidence that PGS improves outcomes for couples experiencing RPL. Comprehensive chromosome screening (PGS2.0) has become a routine practice in  in vitro  fertilisation (IVF) clinics. Previous studies based on PGS1.0 with a focus on RPL couples where the female is of advanced maternal age have reported contradictory results. Hence, a multicentre randomised trial is needed to provide evidence for the clinical benefits of PGS2.0 treatment for RPL couples.
METHODS AND ANALYSIS


Overall, 268 RPL couples undergoing IVF cycles will be enrolled. Couples will be randomised according to a unique grouping number generated by a random digital software into (1) PGS2.0 group and (2) non-PGS (conventional embryo morphology evaluation) group. This study aims to investigate whether the live birth rate (LBR) per initiated cycle after PGS2.0 is superior to the LBR per initiated cycle after conventional embryo evaluation (non-PGS group). Live birth will be defined as a live baby born after a gestation period of >28 weeks, with a birth weight of more than 1000 g. A multivariate logistic regression model will be used to adjust for confounding factors.
ETHICS AND DISSEMINATION


Ethical approval has been granted by the Ethics Committee of Obstetrics and Gynecology Hospital, Fudan University and the participating hospitals. Written informed consent will be obtained from each couple before any study procedure is performed. Data from this study will be stored in the Research Electronic Data Capture. The results of this trial will be presented and published via peer-reviewed publications and presentations at international conferences.
TRIAL REGISTRATION NUMBER


NCT03214185; Pre-results.",2020,Comprehensive chromosome screening (PGS2.0) has become a routine practice in  in vitro  fertilisation (IVF) clinics.,"['patients with recurrent pregnancy loss', '268 RPL couples undergoing IVF cycles will be enrolled']","['PGS2.0 group and (2) non-PGS (conventional embryo morphology evaluation', 'PGS', 'conventional embryo morphology evaluation', 'PGS2.0', 'Comprehensive chromosome screening (PGS2.0', 'Preimplantation genetic screening (PGS']",['live birth rate (LBR'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0156740', 'cui_str': 'Pregnancy in habitual aborter'}, {'cui': 'C4517673', 'cui_str': '268'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0813145', 'cui_str': 'Genetic Screening'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013935', 'cui_str': 'Embryos'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0008633', 'cui_str': 'Chromosome'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0481667', 'cui_str': 'Live birth'}]",,0.365085,Comprehensive chromosome screening (PGS2.0) has become a routine practice in  in vitro  fertilisation (IVF) clinics.,"[{'ForeName': 'Caixia', 'Initials': 'C', 'LastName': 'Lei', 'Affiliation': 'Prenatal Diagnosis Center, Obstetrics and Gynecology Hospital of Fudan University, Shanghai, China.'}, {'ForeName': 'Yilun', 'Initials': 'Y', 'LastName': 'Sui', 'Affiliation': 'Department of Genetics, Shanghai JiAi Genetics & IVF Institute, Shanghai, China.'}, {'ForeName': 'Jiangfeng', 'Initials': 'J', 'LastName': 'Ye', 'Affiliation': 'Clinical Epidemiology, Obstetrics and Gynecology Hospital of Fudan University, Shanghai, China.'}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Reproductive Medical Center, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Ji', 'Initials': 'J', 'LastName': 'Xi', 'Affiliation': 'Reproductive Medical Center, International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Reproductive Medical Center, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Jin', 'Affiliation': 'Reproductive Medical Center, International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Xiaoxi', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'Department of Genetics, Shanghai JiAi Genetics & IVF Institute, Shanghai, China xiaoxi_sun@aliyun.com.'}]",BMJ open,['10.1136/bmjopen-2019-036252']
3197,33033014,Effect of endotracheal tube plus stylet versus endotracheal tube alone on successful first-attempt tracheal intubation among critically ill patients: the multicentre randomised STYLETO study protocol.,"INTRODUCTION


Tracheal intubation is one of the most daily practiced procedures performed in intensive care unit (ICU). It is associated with severe life-threatening complications, which can lead to intubation-related cardiac arrest. Using a preshaped endotracheal tube plus stylet may have potential advantages over endotracheal tube without stylet. The stylet is a rigid but malleable introducer which fits inside the endotracheal tube and allows for manipulation of the tube shape; to facilitate passage of the tube through the laryngeal inlet. However, some complications from stylets have been reported including mucosal bleeding, perforation of the trachea or oesophagus and sore throat. The use of a stylet for first-attempt intubation has never been assessed in ICU and benefit remains to be established.
METHODS AND ANALYSIS


The endotracheal tube plus stylet to increase first-attempt success during orotracheal intubation compared with endotracheal tube alone in ICU patients (STYLETO) trial is an investigator-initiated, multicentre, stratified, parallel-group unblinded trial with an electronic system-based randomisation. Patients will be randomly assigned to undergo the initial intubation attempt with endotracheal tube alone (ie,without stylet, control group) or endotracheal tube + stylet (experimental group). The primary outcome is the proportion of patients with successful first-attempt orotracheal intubation. The single, prespecified, secondary outcome is the incidence of complications related to intubation, in the hour following intubation. Other outcomes analysed will include safety, exploratory procedural and clinical outcomes.
ETHICS AND DISSEMINATION


The study project has been approved by the appropriate ethics committee 'Comité-de-Protection-des-Personnes Nord-Ouest3-19.04.26.65808 Cat2 RECHMPL19_0216/STYLETO2019-A01180-57'"". Informed consent is required. The results will be submitted for publication in a peer-reviewed journal and presented at one or more scientific conferences. If combined use of endotracheal tube plus stylet facilitates tracheal intubation of ICU patients compared with endotracheal tube alone, its use will become standard practice, thereby decreasing first-attempt intubation failure rates and, potentially, the frequency of intubation-related complications.
TRIAL REGISTRATION DETAILS


ClinicalTrials.gov Identifier: NCT04079387; Pre-results.",2020,"The endotracheal tube plus stylet to increase first-attempt success during orotracheal intubation compared with endotracheal tube alone in ICU patients (STYLETO) trial is an investigator-initiated, multicentre, stratified, parallel-group unblinded trial with an electronic system-based randomisation.",['critically ill patients'],"['orotracheal intubation', 'endotracheal tube alone', 'endotracheal tube plus stylet versus endotracheal tube alone', 'endotracheal tube alone (ie,without stylet, control group) or endotracheal tube + stylet (experimental group', 'endotracheal tube plus stylet']","['successful first-attempt tracheal intubation', 'incidence of complications related to intubation, in the hour following intubation', 'mucosal bleeding, perforation of the trachea or oesophagus and sore throat', 'proportion of patients with successful first-attempt orotracheal intubation', 'safety, exploratory procedural and clinical outcomes']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0396621', 'cui_str': 'Orotracheal intubation'}, {'cui': 'C0336630', 'cui_str': 'Endotracheal tube'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0183663', 'cui_str': 'Stylet'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0549099', 'cui_str': 'Perforation'}, {'cui': 'C0040578', 'cui_str': 'Tracheal structure'}, {'cui': 'C0014876', 'cui_str': 'Esophageal structure'}, {'cui': 'C0031350', 'cui_str': 'Pharyngitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0396621', 'cui_str': 'Orotracheal intubation'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.158153,"The endotracheal tube plus stylet to increase first-attempt success during orotracheal intubation compared with endotracheal tube alone in ICU patients (STYLETO) trial is an investigator-initiated, multicentre, stratified, parallel-group unblinded trial with an electronic system-based randomisation.","[{'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Jaber', 'Affiliation': 'Department of Anaesthesiology and Critical Care Medicine B (DAR B), Saint-Eloi Hospital, University Teaching Hospital of Montpellier, 80 avenue Augustin Fliche, 34295 Montpellier, France, Universite de Montpellier, Montpellier, Languedoc-Roussillon, France s-jaber@chu-montpellier.fr.'}, {'ForeName': 'Amélie', 'Initials': 'A', 'LastName': 'Rolle', 'Affiliation': 'Intensive Care & Anesthesiology Department, University of Pointe à Pitre Hospital. Guadeloupe, France, Université des Antilles Bibliothèque Hospitalo-universitaire de Guadeloupe, Pointe-a-Pitre, Guadeloupe.'}, {'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Jung', 'Affiliation': 'PhyMed Exp, Université de Montpellier, INSERM U1046 Montpellier, France, Inserm U1046, Montpellier, Languedoc-Roussillon, France.'}, {'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'Chanques', 'Affiliation': 'Department of Anaesthesiology and Critical Care Medicine B (DAR B), Saint-Eloi Hospital, University Teaching Hospital of Montpellier, 80 avenue Augustin Fliche, 34295 Montpellier, France, Universite de Montpellier, Montpellier, Languedoc-Roussillon, France.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Bertet', 'Affiliation': 'IMAG, CNRS, Univ Montpellier, CHU Montpellier, Montpellier, France, Universite de Montpellier, Montpellier, Languedoc-Roussillon, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Galeazzi', 'Affiliation': 'IMAG, CNRS, Univ Montpellier, CHU Montpellier, Montpellier, France, Universite de Montpellier, Montpellier, Languedoc-Roussillon, France.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Chauveton', 'Affiliation': 'Clinical research department of Montpellier university hospital, Montpellier, Universite de Montpellier, Montpellier, Languedoc-Roussillon, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Molinari', 'Affiliation': 'IMAG, CNRS, Univ Montpellier, CHU Montpellier, Montpellier, France, Universite de Montpellier, Montpellier, Languedoc-Roussillon, France.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'De Jong', 'Affiliation': 'Department of Anaesthesiology and Critical Care Medicine B (DAR B), Saint-Eloi Hospital, University Teaching Hospital of Montpellier, 80 avenue Augustin Fliche, 34295 Montpellier, France, Universite de Montpellier, Montpellier, Languedoc-Roussillon, France.'}]",BMJ open,['10.1136/bmjopen-2019-036718']
3198,33030868,Association of a Pediatric Gynecology eLearning Module With Resident Knowledge and Clinical Skills: A Randomized Controlled Trial.,"OBJECTIVE


To assess whether a pediatric and adolescent gynecology electronic learning (eLearning) module improves knowledge and clinical performance among obstetrics and gynecology residents.
METHODS


We conducted a multi-institutional, single-blinded, randomized controlled trial across four university programs; three had pediatric and adolescent gynecology rotations, and two had pediatric and adolescent gynecology fellowship-trained faculty. Applying permutated block randomization, residents were randomized to no intervention or completion of a validated eLearning module on prepubertal bleeding. All residents subsequently completed a pediatric and adolescent gynecology-related knowledge assessment that queried understanding of prepubertal bleeding and an objective structured clinical examination that assessed history collection, performance of a prepubertal genital examination, vaginal culture, and vaginoscopy for a pediatric patient. Objective structured clinical examinations were videotaped and reviewed by two faculty, blinded to randomization group; interrater reliability score was 97%. We calculated descriptive frequencies and compared randomization groups using χ analyses and Fisher exact tests for categorical variables, and median tests for continuous variables; a value of P<.05 was considered significant.
RESULTS


From July 2018 to June 2019, we invited 115 residents to participate; 97 (83%) completed both objective structured clinical examination and follow-up knowledge assessments. Most were female (91%) and the majority reported limited pediatric and adolescent gynecology didactic or clinical experience, with 36% reporting prior didactics on prepubertal vaginal bleeding and 33% reporting prior exposure to the prepubertal genital examination. Forty-five participants (46%) were randomized to the module and groups were similar across training levels. Residents assigned to the module scored significantly higher on the knowledge assessment (4/5 vs 2/5, P<.001) and objective structured clinical examination (13/16 vs 7/16, P<.001) and were more likely to avoid a speculum in the examination of a pediatric patient (95.6% vs 57.7%, P<.001).
CONCLUSION


Our pediatric and adolescent gynecology eLearning module resulted in improved short-term resident knowledge and simulated clinical skills among obstetrics and gynecology residents. Applying this learning technique in other programs may help address deficiencies in pediatric and adolescent gynecology education and training.",2020,Our pediatric and adolescent gynecology eLearning module resulted in improved short-term resident knowledge and simulated clinical skills among obstetrics and gynecology residents.,"['Pediatric Gynecology eLearning Module With Resident Knowledge and Clinical Skills', 'All residents subsequently completed a pediatric and adolescent gynecology-related knowledge assessment that queried understanding of prepubertal bleeding', 'From July 2018 to June 2019, we invited 115 residents to participate; 97 (83%) completed both objective structured clinical examination and follow-up knowledge assessments', 'four university programs; three had pediatric and adolescent gynecology rotations, and two had pediatric and adolescent gynecology fellowship-trained faculty', 'Forty-five participants (46', 'obstetrics and gynecology residents']","['no intervention or completion of a validated eLearning module', 'pediatric and adolescent gynecology electronic learning (eLearning) module']","['knowledge assessment', 'prepubertal vaginal bleeding', 'knowledge and clinical performance', 'objective structured clinical examination', 'interrater reliability score']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0008973', 'cui_str': 'Clinical Skills'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C3543841', 'cui_str': 'Query'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0015770', 'cui_str': 'Fellowships'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0015535', 'cui_str': 'Faculty'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C1274104', 'cui_str': 'Obstetrics and gynecology'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C2979982', 'cui_str': 'Vaginal bleeding'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.111094,Our pediatric and adolescent gynecology eLearning module resulted in improved short-term resident knowledge and simulated clinical skills among obstetrics and gynecology residents.,"[{'ForeName': 'Patricia S', 'Initials': 'PS', 'LastName': 'Huguelet', 'Affiliation': ""Department of Obstetrics and Gynecology, University of Colorado School of Medicine, and the Division of Pediatric and Adolescent Gynecology, Children's Hospital Colorado, Aurora, Colorado; Pediatric and Adolescent Gynecology, University of Louisville, Norton Healthcare, Louisville, Kentucky; the Department of Obstetrics and Gynecology, Women & Infants Hospital of Rhode Island and Warren Alpert Medical School of Brown University, Providence, Rhode Island; the Division of General Obstetrics and Gynecology, Department of Obstetrics, Gynecology and Newborn Care, the Ottawa Hospital, the Division of Gynecology, Department of Surgery, Children's Hospital of Eastern Ontario, and the Department of Obstetrics and Gynecology, University of Ottawa, Ottawa, Ontario, Canada; the Department of Obstetrics and Gynecology, Virginia Commonwealth University School of Medicine, Richmond, Virginia; and the Division of Family Planning, Department of Obstetrics and Gynecology, University of Colorado School of Medicine, Aurora, Colorado.""}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Abraham', 'Affiliation': ''}, {'ForeName': 'Veronica I', 'Initials': 'VI', 'LastName': 'Alaniz', 'Affiliation': ''}, {'ForeName': 'Andrey V', 'Initials': 'AV', 'LastName': 'Dolinko', 'Affiliation': ''}, {'ForeName': 'Tania', 'Initials': 'T', 'LastName': 'Dumont', 'Affiliation': ''}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Karjane', 'Affiliation': ''}, {'ForeName': 'Janina V', 'Initials': 'JV', 'LastName': 'Pearce', 'Affiliation': ''}, {'ForeName': 'Kara', 'Initials': 'K', 'LastName': 'Ruder', 'Affiliation': ''}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Wheeler', 'Affiliation': ''}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Guiahi', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000004098']
3199,33030881,Foley Bulb Added to an Oral Misoprostol Induction Protocol: A Cluster Randomized Trial.,"OBJECTIVE


To evaluate whether the induction of labor in term gravid women with cervical dilation 2 cm or less and intact membranes by using oral misoprostol preceded by transcervical Foley bulb placement results in a significantly increased vaginal delivery rate compared with the use of oral misoprostol alone.
METHODS


We randomized the induction method by week of admission to labor and delivery, with each week group described as a cluster in a block randomized design. Women with gestational age of 37 weeks or greater, cervical dilation 2 cm or less, intact membranes, and indication for labor induction were included. Study arms were either 100 micrograms of oral misoprostol after transcervical Foley bulb placement or 100 micrograms of oral misoprostol alone. The primary outcome was vaginal delivery with the first induction attempt. Secondary outcomes included time to delivery, clinical chorioamnionitis (maternal temperature of 38°C or greater during labor with or without fundal tenderness, without other identified cause), cesarean delivery indication, and adverse outcomes. We estimated that a sample size of 1,077 per arm was needed to detect a 5% increase in vaginal delivery rate with a type I error of 5% and power of 80%, accounting for interim analysis and cluster size of 30 inductions per week. This was a pragmatic trial, and analysis was by intention-to-treat.
RESULTS


From January 1, 2018, to May 13, 2019, 1,117 women (34 clusters) were assigned to oral misoprostol plus Foley and 1,110 women (34 clusters) to oral misoprostol alone. Demographic characteristics were similar. Vaginal delivery at the first induction occurred in 78% of the misoprostol plus Foley arm and in 77% of the misoprostol arm (relative risk [RR] 1.00; 95% CI 0.96-1.05; adjusted relative risk [aRR], 1.00; 95% CI 0.95-1.05). Clinical chorioamnionitis occurred in 18% of the misoprostol plus Foley arm and in 14% of the misoprostol arm (RR 1.30; 95% CI 1.07-1.58; aRR 1.30; 95% CI 1.08-1.56). There were no differences in neonatal outcomes.
CONCLUSION


Induction of labor in gravid women at term with intact membranes by using oral misoprostol plus Foley bulb did not result in a higher vaginal delivery rate, but it did result in more clinical chorioamnionitis compared with the use of oral misoprostol alone.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov, NCT03407625.",2020,Clinical chorioamnionitis occurred in 18% of the misoprostol plus Foley arm and in 14% of the misoprostol arm (RR 1.30; 95% CI 1.07-1.58; aRR 1.30; 95% CI 1.08-1.56).,"['gravid women at term with intact membranes', 'From January 1, 2018, to May 13, 2019, 1,117 women (34 clusters', 'term gravid women with cervical dilation 2 cm or less and intact membranes', 'Women with gestational age of 37 weeks or greater, cervical dilation 2 cm or less, intact membranes, and indication for labor induction were included']","['misoprostol', 'oral misoprostol', 'oral misoprostol plus Foley', 'oral misoprostol alone', 'misoprostol alone']","['neonatal outcomes', 'Vaginal delivery', 'Clinical chorioamnionitis', 'vaginal delivery with the first induction attempt', 'vaginal delivery rate', 'time to delivery, clinical chorioamnionitis (maternal temperature of 38°C or greater during labor with or without fundal tenderness, without other identified cause), cesarean delivery indication, and adverse outcomes']","[{'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0426199', 'cui_str': 'Intact membranes'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0079103', 'cui_str': 'Cervical dilatation'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0259787', 'cui_str': 'Induction of labor'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0085174', 'cui_str': 'Misoprostol'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0566690', 'cui_str': 'Vaginal delivery'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0008495', 'cui_str': 'Chorioamnionitis'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0234233', 'cui_str': 'Soreness'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}]",,0.370732,Clinical chorioamnionitis occurred in 18% of the misoprostol plus Foley arm and in 14% of the misoprostol arm (RR 1.30; 95% CI 1.07-1.58; aRR 1.30; 95% CI 1.08-1.56).,"[{'ForeName': 'Emily H', 'Initials': 'EH', 'LastName': 'Adhikari', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Nelson', 'Affiliation': ''}, {'ForeName': 'Donald D', 'Initials': 'DD', 'LastName': 'McIntire', 'Affiliation': ''}, {'ForeName': 'Kenneth J', 'Initials': 'KJ', 'LastName': 'Leveno', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000004123']
3200,33038502,"A randomised, double-blind, placebo-controlled, multi-centre, dose-range, proof-of-concept, 24-week treatment study of lanifibranor in adult subjects with non-alcoholic steatohepatitis: Design of the NATIVE study.","Background Non-alcoholic steatohepatitis (NASH), a multifactorial disease, can progress to hepatic fibrosis and cirrhosis. The Peroxysomal Proliferator-Activated Receptors, PPARα, β/δ and γ, play a central role in the regulation of glucose and lipid metabolism and of the inflammatory and fibrogenic pathways in liver and in other organs that all contribute to NASH pathogenesis. Lanifibranor (IVA337), a panPPAR agonist, by acting on these three different PPAR isotypes, combines pharmacological effects that could address the different components of the disease as demonstrated in preclinical models. Objectives NATIVE study (EudraCT: 2016-001979-70, NCT: NCT03008070) aims to assess the safety and the efficacy of a 24-week treatment with lanifibranor (800 and 1200 mg/day) in adult non-cirrhotic NASH patients. The primary efficacy endpoint is a 2-point reduction in the activity part of the Steatosis Activity Fibrosis (SAF) histological score (combining inflammation and ballooning) without worsening of fibrosis. Design NATIVE is a Phase 2b randomised, placebo-controlled, double-blind, parallel-assignment, dose-range study. Eligible adult patients with a confirmed histological diagnosis of NASH should have a SAF Activity score of 3 or 4 (>2) and a SAF Steatosis score ≥ 1. There is no specific criterion related to the fibrosis score except that patients with cirrhosis (F4) were excluded. Summary This study will evaluate the efficacy of a 24-week treatment of NASH with lanifibranor based on histological evaluations (SAF score) by biopsy. The number of responders according to the SAF Activity score-based definition from baseline to 24 weeks will be compared between groups and serves as primary endpoint.",2020,"The Peroxysomal Proliferator-Activated Receptors, PPARα, β/δ and γ, play a central role in the regulation of glucose and lipid metabolism and of the inflammatory and fibrogenic pathways in liver and in other organs that all contribute to NASH pathogenesis.","['adult subjects with non-alcoholic steatohepatitis', 'adult non-cirrhotic NASH patients', 'Eligible adult patients with a confirmed histological diagnosis of NASH should have a SAF Activity score of 3 or 4 (>2) and a SAF Steatosis score\u202f≥', 'patients with cirrhosis (F4']","['lanifibranor', 'placebo', 'NASH with lanifibranor']","['histological evaluations (SAF score', '2-point reduction in the activity part of the Steatosis Activity Fibrosis (SAF) histological score (combining inflammation and ballooning) without worsening of fibrosis']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3241937', 'cui_str': 'Nonalcoholic steatohepatitis'}, {'cui': 'C0439687', 'cui_str': 'Non-cirrhotic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0152254', 'cui_str': 'Fatty degeneration'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}]","[{'cui': 'C5139734', 'cui_str': 'lanifibranor'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3241937', 'cui_str': 'Nonalcoholic steatohepatitis'}]","[{'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0152254', 'cui_str': 'Fatty degeneration'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}]",,0.191775,"The Peroxysomal Proliferator-Activated Receptors, PPARα, β/δ and γ, play a central role in the regulation of glucose and lipid metabolism and of the inflammatory and fibrogenic pathways in liver and in other organs that all contribute to NASH pathogenesis.","[{'ForeName': 'Francque', 'Initials': 'F', 'LastName': 'Sven M', 'Affiliation': 'Department of Gastroenterology and Hepatology, Antwerp University Hospital, Drie Eikenstraat 655, B-2650 Edegem, 2610 Wilrijk, Belgium; Laboratory of Experimental Medicine and Paediatrics, Faculty of Medicine and Health Sciences, University of Antwerp, Universiteitsplein 1, 2610 Wilrijk, Belgium. Electronic address: Sven.Francque@uza.be.'}, {'ForeName': 'Bedossa', 'Initials': 'B', 'LastName': 'Pierre', 'Affiliation': ""Liverpat, 28 rue de l'Amiral Hamelin, 75116 Paris, France.; Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle, Upon Tyne, UK.""}, {'ForeName': 'Abdelmalek', 'Initials': 'A', 'LastName': 'Manal F', 'Affiliation': 'Division of Gastroenterology and Hepatology, Duke University, 40 Duke Medicine Circle, Durham, NC 27710, USA.'}, {'ForeName': 'Anstee', 'Initials': 'A', 'LastName': 'Quentin M', 'Affiliation': 'Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle, Upon Tyne, UK; Newcastle NIHR Biomedical Research Centre, Newcastle upon Tyne, UK; Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.'}, {'ForeName': 'Bugianesi', 'Initials': 'B', 'LastName': 'Elisabetta', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Medical Sciences, University of Torino, A.O. Città della Salute e della Scienza di Torino, Corso Bramante, 88 I-10126 Torino, Italy.'}, {'ForeName': 'Ratziu', 'Initials': 'R', 'LastName': 'Vlad', 'Affiliation': ""AP-HP Hopital Pitié-Salpetrière, 47 Boulevard de L'Hôpital, 75013 Paris, France.""}, {'ForeName': 'Huot-Marchand', 'Initials': 'HM', 'LastName': 'Philippe', 'Affiliation': 'INVENTIVA S.A., 50 rue de DIJON, 21121 Daix, France.'}, {'ForeName': 'Scherrer', 'Initials': 'S', 'LastName': 'Bruno', 'Affiliation': 'Bruno Scherrer Conseil S.A.R.L., 15 rue Beethoven, 78730 Saint Arnoult en Yvelines, France.'}, {'ForeName': 'Junien', 'Initials': 'J', 'LastName': 'Jean-Louis', 'Affiliation': 'INVENTIVA S.A., 50 rue de DIJON, 21121 Daix, France.'}, {'ForeName': 'Broqua', 'Initials': 'B', 'LastName': 'Pierre', 'Affiliation': 'INVENTIVA S.A., 50 rue de DIJON, 21121 Daix, France.'}, {'ForeName': 'Abitbol', 'Initials': 'A', 'LastName': 'Jean-Louis', 'Affiliation': 'INVENTIVA S.A., 50 rue de DIJON, 21121 Daix, France.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106170']
3201,33038504,Facilitating smoking cessation using reduced nicotine cigarettes: Intervention development and RCT study design.,"Smoking cigarettes with substantially lower nicotine than conventional cigarettes prior to a quit attempt may reduce the reinforcing effects of smoking, which could facilitate smoking cessation through extinction learning. This paper describes the development of a smoking cessation intervention designed to optimize extinction processes using reduced nicotine cigarettes, as well as the design and methods for an ongoing randomized controlled trial (RCT) to evaluate this intervention. Qualitative methods and pilot testing were conducted to develop the novel facilitated extinction (FE) intervention, with a key focus on maximizing opportunities for extinction learning during a five-week pre-quit period. The primary aims of the RCT are to test the effects of the FE intervention versus a standard (cognitive-behavioral) intervention, while also comparing two nicotine reduction schedules for providing very low nicotine content (VLNC) cigarettes. The efficacy of the intervention is currently being evaluated with treatment-seeking smokers (n = 208) randomly assigned to one of four conditions crossing FE versus standard intervention with immediate versus gradual transition to VLNC cigarettes.",2020,The efficacy of the intervention is currently being evaluated with treatment-seeking smokers (n = 208) randomly assigned to one of four conditions crossing FE versus standard intervention with immediate versus gradual transition to VLNC cigarettes.,['seeking smokers (n\u202f=\u202f208'],"['RCT', 'FE versus standard intervention with immediate versus gradual transition to VLNC cigarettes', 'FE intervention versus a standard (cognitive-behavioral) intervention']",[],"[{'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0015347', 'cui_str': 'Psychological Extinction'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0439833', 'cui_str': 'Gradual'}, {'cui': 'C0442811', 'cui_str': 'Very low'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",[],208.0,0.0167905,The efficacy of the intervention is currently being evaluated with treatment-seeking smokers (n = 208) randomly assigned to one of four conditions crossing FE versus standard intervention with immediate versus gradual transition to VLNC cigarettes.,"[{'ForeName': 'Melissa R', 'Initials': 'MR', 'LastName': 'Conn', 'Affiliation': 'Department of Health Outcomes and Behavior, H. Lee Moffitt Cancer Center & Research Institute, Tampa, FL, United States of America.'}, {'ForeName': 'Thomas H', 'Initials': 'TH', 'LastName': 'Brandon', 'Affiliation': 'Department of Health Outcomes and Behavior, H. Lee Moffitt Cancer Center & Research Institute, Tampa, FL, United States of America; Department of Psychology, University of South Florida, Tampa, FL, United States of America.'}, {'ForeName': 'Yenis L', 'Initials': 'YL', 'LastName': 'Lorenzo', 'Affiliation': 'Department of Health Outcomes and Behavior, H. Lee Moffitt Cancer Center & Research Institute, Tampa, FL, United States of America.'}, {'ForeName': 'Leslie E', 'Initials': 'LE', 'LastName': 'Sawyer', 'Affiliation': 'Department of Health Outcomes and Behavior, H. Lee Moffitt Cancer Center & Research Institute, Tampa, FL, United States of America; Department of Psychology, University of South Florida, Tampa, FL, United States of America.'}, {'ForeName': 'Vani N', 'Initials': 'VN', 'LastName': 'Simmons', 'Affiliation': 'Department of Health Outcomes and Behavior, H. Lee Moffitt Cancer Center & Research Institute, Tampa, FL, United States of America; Department of Psychology, University of South Florida, Tampa, FL, United States of America.'}, {'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Sutton', 'Affiliation': 'Department of Psychology, University of South Florida, Tampa, FL, United States of America; Department of Biostatistics and Bioinformatics, H. Lee Moffitt Cancer Center & Research Institute, Tampa, FL, United States of America.'}, {'ForeName': 'Eric C', 'Initials': 'EC', 'LastName': 'Donny', 'Affiliation': 'Wake Forest School of Medicine, Wake Forest University, Winston-Salem, NC, United States of America.'}, {'ForeName': 'Dorothy', 'Initials': 'D', 'LastName': 'Hatsukami', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis, MN, United States of America.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Drobes', 'Affiliation': 'Department of Health Outcomes and Behavior, H. Lee Moffitt Cancer Center & Research Institute, Tampa, FL, United States of America; Department of Psychology, University of South Florida, Tampa, FL, United States of America. Electronic address: david.drobes@moffitt.org.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106172']
3202,33038505,The design of a randomized controlled trial to evaluate multi-dimensional effects of a section 1115 Medicaid demonstration waiver with community engagement requirements.,"Section 1115 demonstration waivers provide a mechanism for states to implement changes to their Medicaid programs. While such waivers are mandated to include evaluations of their impact, randomization - the gold standard for assessing causality - has not typically been a consideration. In a critical departure, the Commonwealth of Kentucky opted to pursue a two-arm randomized controlled trial (RCT) for their controversial 2018 Medicaid Demonstration waiver, which included work requirements as a condition for the subset of beneficiaries deemed able-bodied to maintain eligibility for benefits. Beneficiaries were randomized 9:1 to the new waiver program or a control group who would retain their current benefits as part of the existing Medicaid expansion program. To address potential bias from differential attrition from the Medicaid program that would accrue from solely analyzing administrative data, our team designed a rich, prospective, longitudinal survey to collect primary and secondary outcomes from six categories of interest to policymakers: insurance coverage, health care utilization and quality, health behaviors, socioeconomic measures, personal finances, and health outcomes. At baseline, a subset of survey participants was invited to participate in the collection of biometric samples via in-person follow-up visits, and a cross-section were also invited to participate in qualitative interviews. While the demonstration waiver was terminated before the program began, our study design illustrates that it is possible for other researchers and state agencies seeking to evaluate Medicaid demonstration waivers and other demonstration policies to work together to implement high quality randomized trials - even for controversial policies.",2020,Beneficiaries were randomized 9:1 to the new waiver program or a control group who would retain their current benefits as part of the existing Medicaid expansion program.,['section 1115 Medicaid demonstration waiver with community engagement requirements'],['control group who would retain their current benefits as part of the existing Medicaid expansion program'],[],"[{'cui': 'C0025071', 'cui_str': 'Medicaid coverage'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0025071', 'cui_str': 'Medicaid coverage'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",[],,0.0281739,Beneficiaries were randomized 9:1 to the new waiver program or a control group who would retain their current benefits as part of the existing Medicaid expansion program.,"[{'ForeName': 'Kristin A', 'Initials': 'KA', 'LastName': 'Linn', 'Affiliation': 'Department of Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine, University of Pennsylvania, 423 Guardian Dr, Philadelphia, PA 19104, USA; Center for Health Incentives and Behavioral Economics, University of Pennsylvania, 423 Guardian Dr, Philadelphia, PA 19104, USA.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Underhill', 'Affiliation': 'Columbia Law School, New York, NY, USA; Department of Population and Family Health, Mailman School of Public Heath, Columbia University, New York, NY, USA.'}, {'ForeName': 'Erica L', 'Initials': 'EL', 'LastName': 'Dixon', 'Affiliation': 'Center for Health Incentives and Behavioral Economics, University of Pennsylvania, 423 Guardian Dr, Philadelphia, PA 19104, USA; Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania, 423 Guardian Dr, Philadelphia, PA 19104, USA.'}, {'ForeName': 'Elizabeth F', 'Initials': 'EF', 'LastName': 'Bair', 'Affiliation': 'Center for Health Incentives and Behavioral Economics, University of Pennsylvania, 423 Guardian Dr, Philadelphia, PA 19104, USA; Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania, 423 Guardian Dr, Philadelphia, PA 19104, USA.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Ferrell', 'Affiliation': 'Center for Health Incentives and Behavioral Economics, University of Pennsylvania, 423 Guardian Dr, Philadelphia, PA 19104, USA; Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania, 423 Guardian Dr, Philadelphia, PA 19104, USA.'}, {'ForeName': 'Margrethe E', 'Initials': 'ME', 'LastName': 'Montgomery', 'Affiliation': 'National Opinion Research Center at the University of Chicago, Bethesda MD and Chicago, IL, USA.'}, {'ForeName': 'Kevin G', 'Initials': 'KG', 'LastName': 'Volpp', 'Affiliation': 'Center for Health Incentives and Behavioral Economics, University of Pennsylvania, 423 Guardian Dr, Philadelphia, PA 19104, USA; Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania, 423 Guardian Dr, Philadelphia, PA 19104, USA; Department of Medicine, Perelman School of Medicine, University of Pennsylvania, 423 Guardian Dr, Philadelphia, PA 19104, USA; Center for Health Equity Research and Promotion, Cresencz VA Medical Center, Philadelphia, USA.'}, {'ForeName': 'Atheendar S', 'Initials': 'AS', 'LastName': 'Venkataramani', 'Affiliation': 'Center for Health Incentives and Behavioral Economics, University of Pennsylvania, 423 Guardian Dr, Philadelphia, PA 19104, USA; Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania, 423 Guardian Dr, Philadelphia, PA 19104, USA. Electronic address: atheenv@pennmedicine.upenn.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106173']
3203,33038506,A mHealth intervention to preserve and promote ideal cardiovascular health in college students: Design and protocol of a cluster randomized controlled trial.,"BACKGROUND


Cardiovascular disease (CVD) remains the leading cause of death globally. Seven health factors are associated with ideal cardiovascular health: being a non-smoker; not overweight; physically active; having a healthy diet; and normal blood pressure; fasting plasma glucose and cholesterol. Whereas approximately half of U.S. youth have ideal levels in at least 5 of the 7 components of cardiovascular health, this proportion falls to 16% by adulthood.
OBJECTIVE


We will evaluate whether the NUYou cardiovascular mHealth intervention is more effective than an active comparator to promote cardiovascular health during the transition to young adulthood.
METHODS


302 incoming freshmen at a midwest university will be cluster randomized by dormitory into one of two mHealth intervention groups: 1) Cardiovascular Health (CVH), addressing behaviors related to CVD risk; or 2) Whole Health (WH), addressing behaviors unrelated to CVD. Both groups will receive smartphone applications, co-designed with students to help them manage time, interact with other participants via social media, and report health behaviors weekly. The CVH group will also have self-monitoring features to track their risk behaviors. Cardiovascular health will be assessed at the beginning of freshman year and the end of freshman and sophomore years. Linear mixed models will be used to compare groups on a composite of the seven cardiovascular-related health factors.
SIGNIFICANCE


This is the first entirely technology-mediated multiple health behavior change intervention delivered to college students to promote cardiovascular health. Findings will inform the potential for primordial prevention in young adulthood.
TRIAL REGISTRATION NUMBER


clinicaltrials.gov #NCT02496728.",2020,"Whereas approximately half of U.S. youth have ideal levels in at least 5 of the 7 components of cardiovascular health, this proportion falls to 16% by adulthood.
","['young adulthood', 'college students', '302 incoming freshmen at a midwest university will be cluster randomized by dormitory into one of two mHealth intervention groups: 1']","['Cardiovascular Health (CVH), addressing behaviors related to CVD risk; or 2) Whole Health (WH), addressing behaviors unrelated to CVD', 'CVH', 'NUYou cardiovascular mHealth intervention']",['Cardiovascular health'],"[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0700597', 'cui_str': 'Adulthood'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0376649', 'cui_str': 'Addresses'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0445356', 'cui_str': 'Unrelated'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",302.0,0.114352,"Whereas approximately half of U.S. youth have ideal levels in at least 5 of the 7 components of cardiovascular health, this proportion falls to 16% by adulthood.
","[{'ForeName': 'Angela F', 'Initials': 'AF', 'LastName': 'Pfammatter', 'Affiliation': 'Northwestern University Feinberg School of Medicine, United States of America. Electronic address: angela@northwestern.edu.'}, {'ForeName': 'Katrina E', 'Initials': 'KE', 'LastName': 'Champion', 'Affiliation': 'University of Sydney, Australia. Electronic address: katrina.champion@sydney.edu.au.'}, {'ForeName': 'Laura E', 'Initials': 'LE', 'LastName': 'Finch', 'Affiliation': 'NORC at the University of Chicago, United States of America. Electronic address: Finch-laura@norc.org.'}, {'ForeName': 'Juned', 'Initials': 'J', 'LastName': 'Siddique', 'Affiliation': 'Northwestern University Feinberg School of Medicine, United States of America. Electronic address: Siddique@northwestern.edu.'}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Hedeker', 'Affiliation': 'University of Chicago, United States of America. Electronic address: hedeker@uchicago.edu.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Spring', 'Affiliation': 'Northwestern University Feinberg School of Medicine, United States of America. Electronic address: bspring@northwestern.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106162']
3204,33041146,MAGraine: Magnesium compared to conventional therapy for treatment of migraines.,"Due to the healthcare burden associated with migraines, prompt and effective treatment is vital to improve patient outcomes and ED workflow. This was a prospective, randomized, double-blind trial. Adults who presented to the ED with a diagnosis of migraine from August of 2019 to March of 2020 were included. Pregnant patients, or with renal impairment were excluded. Patients were randomized to receive intravenous magnesium, prochlorperazine, or metoclopramide. The primary outcome was change in pain from baseline on a numeric rating scale (NRS) evaluated at 30 min after initiation of infusion of study drug. Secondary outcomes included NRS at 60 and 120 min, ED length of stay, necessity for rescue analgesia, and adverse effects. A total of 157 patients were analyzed in this study. Sixty-one patients received magnesium, 52 received prochlorperazine, and 44 received metoclopramide. Most patients were white females, and the median age was 36 years. Hypertension and migraines were the most common comorbidities, with a third of the patients reporting an aura. There was a median decrease in NRS at 30 min of three points across all three treatment arms. The median decrease in NRS (IQR) at 60 min was -4 (2-6) in the magnesium group, -3 (2-5) in the metoclopramide group, and -4.5 (2-7) in the prochlorperazine group (p = 0.27). There were no statistically significant differences in ED length of stay, rescue analgesia, or adverse effects. Reported adverse effects were dizziness, anxiety, and akathisia. No significant difference was observed in NRS at 30 min between magnesium, metoclopramide and prochlorperazine.",2020,"No significant difference was observed in NRS at 30 min between magnesium, metoclopramide and prochlorperazine.","['migraines', 'Most patients were white females, and the median age was 36\xa0years', 'Adults who presented to the ED with a diagnosis of migraine from August of 2019 to March of 2020 were included', 'Pregnant patients, or with renal impairment were excluded', 'A total of 157 patients']","['magnesium', 'magnesium, metoclopramide', 'conventional therapy', 'metoclopramide', 'prochlorperazine', 'MAGraine: Magnesium', 'intravenous magnesium, prochlorperazine, or metoclopramide']","['NRS', 'numeric rating scale (NRS', 'Hypertension and migraines', 'ED length of stay, rescue analgesia, or adverse effects', 'dizziness, anxiety, and akathisia', 'median decrease in NRS (IQR', 'NRS at 60 and 120\xa0min, ED length of stay, necessity for rescue analgesia, and adverse effects', 'change in pain']","[{'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0910435', 'cui_str': 'AM 36'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0025853', 'cui_str': 'Metoclopramide'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0033229', 'cui_str': 'Prochlorperazine'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0392156', 'cui_str': 'Akathisia'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",157.0,0.542968,"No significant difference was observed in NRS at 30 min between magnesium, metoclopramide and prochlorperazine.","[{'ForeName': 'Manar', 'Initials': 'M', 'LastName': 'Kandil', 'Affiliation': 'Department of Pharmacy, Advocate Christ Medical Center, Oak Lawn, IL, United States of America. Electronic address: manar.kandil87@gmail.com.'}, {'ForeName': 'Sabrin', 'Initials': 'S', 'LastName': 'Jaber', 'Affiliation': 'Department of Pharmacy, Advocate Christ Medical Center, Oak Lawn, IL, United States of America.'}, {'ForeName': 'Dharati', 'Initials': 'D', 'LastName': 'Desai', 'Affiliation': 'Department of Pharmacy, Advocate Christ Medical Center, Oak Lawn, IL, United States of America.'}, {'ForeName': 'Stephany', 'Initials': 'S', 'LastName': 'Nuñez Cruz', 'Affiliation': 'Department of Pharmacy, Advocate Christ Medical Center, Oak Lawn, IL, United States of America.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Lomotan', 'Affiliation': 'Department of Pharmacy, Advocate Christ Medical Center, Oak Lawn, IL, United States of America.'}, {'ForeName': 'Uzma', 'Initials': 'U', 'LastName': 'Ahmad', 'Affiliation': 'Department of Emergency Medicine, Advocate Christ Medical Center, Oak Lawn, IL, United States of America.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Cirone', 'Affiliation': 'Department of Emergency Medicine, Advocate Christ Medical Center, Oak Lawn, IL, United States of America.'}, {'ForeName': 'Jaxson', 'Initials': 'J', 'LastName': 'Burkins', 'Affiliation': 'Department of Pharmacy, Advocate Christ Medical Center, Oak Lawn, IL, United States of America.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'McDowell', 'Affiliation': 'Department of Pharmacy, Advocate Christ Medical Center, Oak Lawn, IL, United States of America.'}]",The American journal of emergency medicine,['10.1016/j.ajem.2020.09.033']
3205,33030225,"Suitability of low-dose, open food challenge data to supplement double-blind, placebo-controlled data in generation of food allergen threshold dose distributions.",,2020,Food allergen threshold dose-distributions are used in food allergen risk assessment to determine the level of risk within a food allergic population to a defined exposure amount of allergenic food protein and to help inform allergen risk management decisions.,[],['Placebo'],[],[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.0304595,Food allergen threshold dose-distributions are used in food allergen risk assessment to determine the level of risk within a food allergic population to a defined exposure amount of allergenic food protein and to help inform allergen risk management decisions.,"[{'ForeName': 'Benjamin C', 'Initials': 'BC', 'LastName': 'Remington', 'Affiliation': 'The Netherlands Organisation for Applied Scientific Research TNO, Utrecht, The Netherlands.'}, {'ForeName': 'Joost', 'Initials': 'J', 'LastName': 'Westerhout', 'Affiliation': 'The Netherlands Organisation for Applied Scientific Research TNO, Utrecht, The Netherlands.'}, {'ForeName': 'Anthony E J', 'Initials': 'AEJ', 'LastName': 'Dubois', 'Affiliation': 'University Medical Centre Groningen, Groningen, The Netherlands.'}, {'ForeName': 'W Marty', 'Initials': 'WM', 'LastName': 'Blom', 'Affiliation': 'The Netherlands Organisation for Applied Scientific Research TNO, Utrecht, The Netherlands.'}, {'ForeName': 'Astrid G', 'Initials': 'AG', 'LastName': 'Kruizinga', 'Affiliation': 'The Netherlands Organisation for Applied Scientific Research TNO, Utrecht, The Netherlands.'}, {'ForeName': 'Steve L', 'Initials': 'SL', 'LastName': 'Taylor', 'Affiliation': 'Food Allergy Research and Resource Program, University of Nebraska, Lincoln, NE, USA.'}, {'ForeName': 'Geert F', 'Initials': 'GF', 'LastName': 'Houben', 'Affiliation': 'The Netherlands Organisation for Applied Scientific Research TNO, Utrecht, The Netherlands.'}, {'ForeName': 'Joseph L', 'Initials': 'JL', 'LastName': 'Baumert', 'Affiliation': 'Food Allergy Research and Resource Program, University of Nebraska, Lincoln, NE, USA.'}]",Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology,['10.1111/cea.13753']
3206,33030515,Effect of Weekly Paclitaxel With or Without Bevacizumab on Progression-Free Rate Among Patients With Relapsed Ovarian Sex Cord-Stromal Tumors: The ALIENOR/ENGOT-ov7 Randomized Clinical Trial.,"Importance


To our knowledge, this is the first randomized trial in sex cord-stromal tumors, and it establishes weekly paclitaxel as standard-of-care therapy after platinum-based therapy in this setting.
Objective


To determine the efficacy of weekly paclitaxel with or without bevacizumab as treatment for relapsed sex cord-stromal tumors and evaluate whether the addition of bevacizumab to weekly paclitaxel improves 6-month progression-free rate.
Design, Setting, and Participants


This open-label, academic, international, randomized phase 2 trial (ALIENOR) was conducted at 28 referral centers in France, Germany, Italy, Japan, and Belgium in collaboration with the Rare Tumor committee of the Gynecologic Cancer InterGroup and used an adaptive bayesian design. It included 60 women with sex cord-stromal tumors that had relapsed after at least 1 platinum-based chemotherapy. Enrollment occurred from 2013 to 2016, and the final analysis database lock was on March 27, 2020 (median follow-up, 38.9 months).
Interventions


Participants were randomized to receive either paclitaxel (80 mg/m2, days 1, 8, and 15 every 4 weeks) alone or paclitaxel with bevacizumab (10 mg/kg, every 2 weeks) for 6 cycles followed by maintenance bevacizumab (15 mg/kg, every 3 weeks) for up to 1 year or until progression or unacceptable toxicity. Crossover to bevacizumab was permitted after progression during or following paclitaxel alone.
Main Outcomes and Measures


Six-month progression-free rate.
Results


Sixty patients (predominantly with granulosa cell tumors) were randomized, 32 to receive single-agent paclitaxel (median [interquartile range] age at inclusion, 60 [53-64] years) and 28 to receive paclitaxel-bevacizumab (median [interquartile range] age at inclusion, 55 [47-61] years; 1 did not receive treatment). The estimated 6-month progression-free rate was 71% (95% credible interval, 55%-84%) with paclitaxel alone and 72% (95% credible interval, 55%-87%) with paclitaxel-bevacizumab. The bayesian estimate for the probability that the 6-month progression-free rate distribution was higher with the combination than with paclitaxel alone was 57%, less than the predefined superiority threshold. The objective response rate increased from 25% (95% CI, 12%-43%) to 44% (95% CI, 26%-65%) with the addition of bevacizumab. One patient discontinued combination therapy within 6 months because of toxicity.
Conclusions and Relevance


Weekly paclitaxel is a new option for relapsed sex cord-stromal tumors. In this international randomized clinical trial of patients with relapsed sex cord-stromal tumors unsuitable for surgery, adding bevacizumab to weekly paclitaxel does not improve clinical benefit.
Trial Registration


ClinicalTrials.gov Identifier: NCT01770301.",2020,"The estimated 6-month progression-free rate was 71% (95% credible interval, 55%-84%) with paclitaxel alone and 72% (95% credible interval, 55%-87%) with paclitaxel-bevacizumab.","['patients with relapsed sex cord-stromal tumors unsuitable for surgery, adding', '28 referral centers in France, Germany, Italy, Japan, and Belgium in collaboration with the Rare Tumor committee of the Gynecologic Cancer InterGroup and used an adaptive bayesian design', 'Patients', 'median [interquartile range] age at inclusion, 60 [53-64] years) and 28 to receive', 'Sixty patients (predominantly with granulosa cell tumors', '60 women with sex cord-stromal tumors that had relapsed after at least 1 platinum-based chemotherapy', 'With Relapsed Ovarian Sex Cord-Stromal Tumors', 'relapsed sex cord-stromal tumors']","['paclitaxel with bevacizumab', 'paclitaxel', 'Weekly Paclitaxel With or Without Bevacizumab', 'bevacizumab', 'paclitaxel-bevacizumab', 'bevacizumab to weekly paclitaxel', 'paclitaxel with or without bevacizumab', 'single-agent paclitaxel', 'maintenance bevacizumab']","['Measures\n\n\nSix-month progression-free rate', '6-month progression-free rate distribution', '6-month progression-free rate', 'estimated 6-month progression-free rate', 'Progression-Free Rate', 'objective response rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0206724', 'cui_str': 'Sex cord-stromal tumor'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}, {'cui': 'C0521114', 'cui_str': 'Infrequent'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0699889', 'cui_str': 'Female reproductive neoplasm malignant NOS'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0018206', 'cui_str': 'Granulosa cell tumor'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0600113', 'cui_str': 'Sex cord tumor of ovary'}]","[{'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]","[{'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]",60.0,0.232113,"The estimated 6-month progression-free rate was 71% (95% credible interval, 55%-84%) with paclitaxel alone and 72% (95% credible interval, 55%-87%) with paclitaxel-bevacizumab.","[{'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Ray-Coquard', 'Affiliation': 'GINECO and Centre Léon Bérard, University Claude Bernard Lyon 1, Lyon, France.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Harter', 'Affiliation': 'AGO Study Group and Ev Kliniken Essen-Mitte, Essen, Germany.'}, {'ForeName': 'Domenica', 'Initials': 'D', 'LastName': 'Lorusso', 'Affiliation': 'MITO and Istituto Nazionale Tumori, Milan, Italy.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Dalban', 'Affiliation': 'GINECO and Department of Clinical Research and Innovation, Centre Léon Bérard, Lyon, France.'}, {'ForeName': 'Ignace', 'Initials': 'I', 'LastName': 'Vergote', 'Affiliation': 'BGOG and University Hospital Leuven, Leuven Cancer Institute, Leuven, Belgium.'}, {'ForeName': 'Keiichi', 'Initials': 'K', 'LastName': 'Fujiwara', 'Affiliation': 'GOTIC and Saitama Medical University International Medical Center, Hidaka, Japan.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Gladieff', 'Affiliation': 'GINECO and Institut Claudius Regaud, IUCT-Oncopole, Toulouse, France.'}, {'ForeName': 'Hans-Joachim', 'Initials': 'HJ', 'LastName': 'Lück', 'Affiliation': 'AGO Study Group and Gyneco-Oncological Practice, Hannover, Germany.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Floquet', 'Affiliation': 'GINECO and Institut Bergonié, Bordeaux, France.'}, {'ForeName': 'Annick', 'Initials': 'A', 'LastName': 'Chevalier-Place', 'Affiliation': 'GINECO and Centre Oscar Lambret, Lille, France.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Schnelzer', 'Affiliation': 'AGO Study Group and Frauenklinik Technical University Munich, Munich, Germany.'}, {'ForeName': 'Sandro', 'Initials': 'S', 'LastName': 'Pignata', 'Affiliation': 'MITO and Department of Urology and Gynecology, Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, Napoli, Italy.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Selle', 'Affiliation': 'GINECO and Groupe Hospitalier Diaconesses Croix Saint-Simon, Paris, France.'}, {'ForeName': 'Jalid', 'Initials': 'J', 'LastName': 'Sehouli', 'Affiliation': 'AGO Study Group and Medical University of Berlin, Charité-CVK, Berlin, Germany.'}, {'ForeName': 'Fabien', 'Initials': 'F', 'LastName': 'Brocard', 'Affiliation': 'GINECO and Centre Oncologie de Gentilly, Nancy, France.'}, {'ForeName': 'Giorgia', 'Initials': 'G', 'LastName': 'Mangili', 'Affiliation': 'MITO and Ospedale San Raffaele, Milan, Italy.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Pautier', 'Affiliation': 'GINECO and Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Ugo', 'Initials': 'U', 'LastName': 'De Giorgi', 'Affiliation': 'MITO and Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori IRST IRCCS, Meldola, Italy.'}, {'ForeName': 'Magali', 'Initials': 'M', 'LastName': 'Provansal', 'Affiliation': 'GINECO and Institut Paoli Calmettes, Marseille, France.'}, {'ForeName': 'Pierre-Etienne', 'Initials': 'PE', 'LastName': 'Heudel', 'Affiliation': 'GINECO and Centre Léon Bérard, Lyon, France.'}]",JAMA oncology,['10.1001/jamaoncol.2020.4574']
3207,33026766,"Hydrogen Peroxide Topical Solution, 45% for Common Warts: Phase 2 Efficacy and Safety Trial Results.","BACKGROUND


No FDA-approved prescription therapies are available for common warts.
OBJECTIVE


We evaluated a proprietary hydrogen peroxide topical solution, 45% (w/w) (HP45) for treatment of common warts.
METHODS


In the phase 2 randomized, double-blind, vehicle-controlled WART-203 trial (NCT03278028), eligible patients aged &ge;8 years had 1&ndash;6 warts (1 target wart) on the trunk or extremities with a Physician&rsquo;s Wart Assessment&trade; (PWA) grade &ge;2 (range, 0 [clear] to 3 [wart 3&ndash;8 mm in diameter or length]). Patients self-administered HP45 or vehicle twice weekly for 8 weeks and were evaluated through 12 weeks posttreatment (week 20). Efficacy assessments included mean change in target wart PWA grade from baseline at week 8 (primary endpoint) and proportions of patients with target wart clearance. Safety assessments included treatment-emergent adverse events (TEAEs) and local skin reactions (LSRs).
RESULTS


A total of 157 patients completed 8 weeks of treatment (HP45, n=79; vehicle, n=78); 151 patients completed the 20-week posttreatment evaluation (HP45, n=75; vehicle, n=76). A significantly greater reduction in mean target wart PWA grade from baseline at week 8 was achieved with HP45 (&minus;0.87) vs vehicle (&minus;0.17; P&lt;0.0001) and maintained at week 20 (&minus;1.00 vs &minus;0.39; P=0.0004). The proportion of patients with target wart clearance at week 8 was significantly greater with HP45 (25.3%) vs vehicle (2.6%; P&lt;0.0001) and remained significantly greater at week 20 (37.3% vs 11.8%; P=0.0002). Forty-seven patients reported 76 TEAEs; most were mild or moderate in severity. Most LSRs were mild and resolved by week 20. In pediatric patients (HP45, n=13; vehicle, n=6), greater reductions in mean target wart PWA grade from baseline were observed with HP45 vs vehicle at weeks 8 (&minus;1.0 vs 0) and 20 (&minus;1.2 vs &minus;0.5).
CONCLUSION


These findings support the efficacy and safety of HP45 for the treatment of common warts in patients &ge;8 years of age. J Drugs Dermatol. 2020;19(10):969-976. doi:10.36849/JDD.2020.5054.",2020,These findings support the efficacy and safety of HP45 for the treatment of common warts in patients &ge;8 years of age.,"['eligible patients aged &ge;8 years had 1&ndash;6 warts (1 target wart) on the trunk or extremities with a Physician&rsquo;s Wart Assessment&trade', '157 patients completed 8 weeks of treatment (HP45, n=79; vehicle, n=78); 151 patients completed the 20-week posttreatment evaluation (HP45, n=75; vehicle, n=76', 'common warts in patients &ge;8 years of age']","['Hydrogen Peroxide Topical Solution', 'hydrogen peroxide topical solution, 45% (w/w) (HP45']","['proportion of patients with target wart clearance', 'Safety assessments included treatment-emergent adverse events (TEAEs) and local skin reactions (LSRs', 'mild or moderate in severity', 'efficacy and safety of HP45', 'mean target wart PWA grade']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043037', 'cui_str': 'Verruca'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1246476', 'cui_str': 'Hydrogen Peroxide Topical Solution'}, {'cui': 'C2919747', 'cui_str': 'w/w'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C1246476', 'cui_str': 'Hydrogen Peroxide Topical Solution'}, {'cui': 'C2919747', 'cui_str': 'w/w'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043037', 'cui_str': 'Verruca'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0221743', 'cui_str': 'Skin reaction'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1246476', 'cui_str': 'Hydrogen Peroxide Topical Solution'}, {'cui': 'C2919747', 'cui_str': 'w/w'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0441800', 'cui_str': 'Grade'}]",157.0,0.315755,These findings support the efficacy and safety of HP45 for the treatment of common warts in patients &ge;8 years of age.,"[{'ForeName': 'Stacy R', 'Initials': 'SR', 'LastName': 'Smith', 'Affiliation': ''}, {'ForeName': 'Stephen K', 'Initials': 'SK', 'LastName': 'Tyring', 'Affiliation': ''}, {'ForeName': 'Kimberly K', 'Initials': 'KK', 'LastName': 'Grande', 'Affiliation': ''}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Schlessinger', 'Affiliation': ''}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Gold', 'Affiliation': ''}, {'ForeName': 'Stuart D', 'Initials': 'SD', 'LastName': 'Shanier', 'Affiliation': ''}]",Journal of drugs in dermatology : JDD,['10.36849/JDD.2020.5054']
3208,33028064,Long-term benefits of chest compression-only cardiopulmonary resuscitation training using real-time visual feedback manikins: a randomized simulation study.,"OBJECTIVE


Cardiopulmonary resuscitation (CPR) education with a feedback device is known to result in better CPR skills compared to one without the feedback device. However, its long-term benefits have not been established. The purpose of this study was to evaluate the long-term CPR skill retention after training using real-time visual manikins in comparison to that of non-feedback manikins.
METHODS


We recruited 120 general university students who were randomly divided into the real-time feedback group (RTFG) and the non-feedback group. Of them, 95 (RTFG, 48; non-feedback group, 47) attended basic life support and automated external defibrillation training for 1 hour. For comparison of retention of CPR skills, the two groups were evaluated based on 2-minute chest compression performed immediately after training and at 3, 6, and 9 months. The CPR parameters between the two groups were also compared using a generalized linear model.
RESULTS


At immediately after training, the performance of RTFG was better in terms of average chest compression depth (51.9±1.1 vs. 45.5±1.1, p<0.001) and a higher percentage of adequate chest compression depth (51.0±4.1 vs. 26.9±4.2, p<0.001). This significant difference was maintained until 6 months after training, but there was no difference at 9 months after training. However, there was no significant difference in the chest compression rate and the correct hand position at any time point.
CONCLUSION


CPR training with a real-time visual feedback manikin improved skill acquisition in chest compression depth, but only until 6 months after the training. It could be a more effective educational method for basic life support training in laypersons.",2020,"At immediately after training, the performance of RTFG was better in terms of average chest compression depth (51.9±1.1 vs. 45.5±1.1, p<0.001) and a higher percentage of adequate chest compression depth (51.0±4.1 vs. 26.9±4.2, p<0.001).",['120 general university students who were randomly divided into the'],"['real-time feedback group (RTFG) and the non-feedback group', 'CPR training with a real-time visual feedback manikin', 'chest compression-only cardiopulmonary resuscitation training']","['chest compression rate', 'CPR parameters', 'adequate chest compression depth', 'average chest compression depth']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0332849', 'cui_str': 'Divide'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C2936181', 'cui_str': 'Visual Feedback'}, {'cui': 'C0024722', 'cui_str': 'Mannequins'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0332459', 'cui_str': 'Compression'}]","[{'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0205125', 'cui_str': 'Deep'}]",120.0,0.0304546,"At immediately after training, the performance of RTFG was better in terms of average chest compression depth (51.9±1.1 vs. 45.5±1.1, p<0.001) and a higher percentage of adequate chest compression depth (51.0±4.1 vs. 26.9±4.2, p<0.001).","[{'ForeName': 'Tae Chang', 'Initials': 'TC', 'LastName': 'Jang', 'Affiliation': 'Department of Emergency Medicine, Daegu Catholic University School of Medicine, Daegu, Korea.'}, {'ForeName': 'Hyun Wook', 'Initials': 'HW', 'LastName': 'Ryoo', 'Affiliation': 'Department of Emergency Medicine, Kyungpook National University School of Medicine, Daegu, Korea.'}, {'ForeName': 'Sungbae', 'Initials': 'S', 'LastName': 'Moon', 'Affiliation': 'Department of Emergency Medicine, Kyungpook National University School of Medicine, Daegu, Korea.'}, {'ForeName': 'Jae Yun', 'Initials': 'JY', 'LastName': 'Ahn', 'Affiliation': 'Department of Emergency Medicine, Kyungpook National University School of Medicine, Daegu, Korea.'}, {'ForeName': 'Dong Eun', 'Initials': 'DE', 'LastName': 'Lee', 'Affiliation': 'Department of Emergency Medicine, Kyungpook National University School of Medicine, Daegu, Korea.'}, {'ForeName': 'Won Kee', 'Initials': 'WK', 'LastName': 'Lee', 'Affiliation': 'Department of Medical Informatics, Kyungpook National University School of Medicine, Daegu, Korea.'}, {'ForeName': 'Sang Gyu', 'Initials': 'SG', 'LastName': 'Kwak', 'Affiliation': 'Department of Medical Statistics, Daegu Catholic University School of Medicine, Daegu, Korea.'}, {'ForeName': 'Jung Ho', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Department of Emergency Medicine, Yeungnam University College of Medicine, Daegu, Korea.'}]",Clinical and experimental emergency medicine,['10.15441/ceem.20.022']
3209,33028455,A randomised test of the effect of medical  v . lay idiom on assessment of perceived mental health condition in the USA.,"AIMS


To test the impact of using different idioms in epidemiological interviews on the prevalence and correlates of poor mental health and mental health service use.
METHODS


We conducted a randomised methodological experiment in a nationally representative sample of the US adult population, comparing a lay idiom, which asked about 'problems with your emotions or nerves' with a more medical idiom, which asked about 'problems with your mental health'. Differences across study arms in the associations of endorsement of problems with the Kessler-6 (a validated assessment of psychological distress), demographic characteristics, self-rated health and mental health service use were examined.
RESULTS


Respondents were about half as likely to endorse a problem when asked with the more medical idiom (18.1%) than when asked with the lay idiom (35.1%). The medical idiom had a significantly larger area under the ROC curve when compared against a validated measure of psychological distress than the lay idiom (0.91 v. 0.87, p = 0.012). The proportion of the population who endorsed a problem but did not receive treatment in the past year was less than half as large for the medical idiom (7.90%) than for the lay idiom (20.94%). Endorsement of problems differed in its associations with age, sex, race/ethnicity and self-rated health depending on the question idiom. For instance, the odds of endorsing problems were threefold higher in the youngest than the oldest age group when the medical idiom was used (OR = 3.07; 95% CI 1.47-6.41) but did not differ across age groups when the lay idiom was used (OR = 0.76; 95% CI 0.43-1.36).
CONCLUSION


Choice of idiom in epidemiological questionnaires can affect the apparent correlates of poor mental health and service use. Cultural change within populations over time may require changes in instrument wording to maintain consistency in epidemiological measurement of psychiatric conditions.",2020,"Differences across study arms in the associations of endorsement of problems with the Kessler-6 (a validated assessment of psychological distress), demographic characteristics, self-rated health and mental health service use were examined.
","[""nationally representative sample of the US adult population, comparing a lay idiom, which asked about 'problems with your emotions or nerves' with a more medical idiom, which asked about 'problems with your mental health""]",['medical  v . lay idiom'],"['psychological distress', 'psychological distress), demographic characteristics, self-rated health and mental health service use', 'odds of endorsing problems', 'larger area under the ROC curve']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C1172410', 'cui_str': 'ASK protein, human'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]","[{'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0023668', 'cui_str': 'Liechtenstein'}]","[{'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0025355', 'cui_str': 'Mental health service'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0035787', 'cui_str': 'ROC Analysis'}]",,0.0553389,"Differences across study arms in the associations of endorsement of problems with the Kessler-6 (a validated assessment of psychological distress), demographic characteristics, self-rated health and mental health service use were examined.
","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Breslau', 'Affiliation': 'RAND Corporation, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'McBain', 'Affiliation': 'RAND Corporation, Boston, Massachusetts, USA.'}, {'ForeName': 'E C', 'Initials': 'EC', 'LastName': 'Wong', 'Affiliation': 'RAND Corporation, Santa Monica, California, USA.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Roth', 'Affiliation': 'RAND Corporation, Santa Monica, California, USA.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Burnam', 'Affiliation': 'RAND Corporation, Santa Monica, California, USA.'}, {'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'Cefalu', 'Affiliation': 'RAND Corporation, Santa Monica, California, USA.'}, {'ForeName': 'R L', 'Initials': 'RL', 'LastName': 'Collins', 'Affiliation': 'RAND Corporation, Santa Monica, California, USA.'}]",Epidemiology and psychiatric sciences,['10.1017/S2045796020000840']
3210,33028548,"SIZE study: study protocol of a multicentre, randomised controlled trial to compare the effectiveness of an interarcuair decompression versus extended decompression in patients with intermittent neurogenic claudication caused by lumbar spinal stenosis.","INTRODUCTION


Intermittent neurogenic claudication (INC) is often caused by lumbar spinal stenosis (LSS). Laminectomy is considered a frequently used surgical technique for LSS. Previous studies have shown that laminectomy can potentially cause lumbar instability. Less invasive techniques, preserving midline structures including the bilateral small size interarcuair decompression, are currently applied. Due to lack of evidence and consensus, surgeons have to rely on their training and own experiences to choose the best surgical techniques for their patients. Hence, an observer and patient blinded multicentre, randomised controlled trial was designed to determine the effectiveness and cost-effectiveness of bilateral interarcuair decompression versus laminectomy for LSS.
METHODS AND ANALYSIS


174 patients above 40 years with at least 12 weeks of INC will be recruited. Patients are eligible for inclusion if they have a clinical indication for surgery for INC with an MRI showing signs of LSS. Patients will be randomised to laminectomy or bilateral interarcuair decompression. The primary outcome is functional status measured with the Roland-Morris Disability Questionnaire at 12 months. Secondary outcomes consist of pain intensity, self-perceived recovery, functional status measured with the Oswestry Disability Index and a physical examination. Outcome measurement moments will be scheduled at 3 and 6 weeks, and at 3, 6, 12, 18, 24, 36 and 48 months after surgery. Physical examination will be performed at 6 weeks, and 12, 24 and 48 months. An economic evaluation will be performed and questionnaires will be used to collect cost data.
ETHICS AND DISSEMINATION


The Medical Ethical Committee of the Erasmus Medical Centre Rotterdam approved this study (NL.65826.078.18). The results will be published in an international peer-reviewed journal.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov (NCT03480893).
IRB APPROVAL STATUS


MEC-2018-093.",2020,"Secondary outcomes consist of pain intensity, self-perceived recovery, functional status measured with the Oswestry Disability Index and a physical examination.","['Patients are eligible for inclusion if they have a clinical indication for surgery for INC with an MRI showing signs of LSS', 'patients with intermittent neurogenic claudication caused by lumbar spinal stenosis', '174 patients above 40 years with at least 12 weeks of INC will be recruited']","['bilateral interarcuair decompression versus laminectomy', 'laminectomy', 'interarcuair decompression versus extended decompression', 'laminectomy or bilateral interarcuair decompression']","['effectiveness and cost-effectiveness', 'functional status measured with the Roland-Morris Disability Questionnaire', 'pain intensity, self-perceived recovery, functional status measured with the Oswestry Disability Index and a physical examination']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0580173', 'cui_str': 'Neurogenic claudication'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0158288', 'cui_str': 'Spinal stenosis of lumbar region'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C4517604', 'cui_str': '174'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0011117', 'cui_str': 'Decompression'}, {'cui': 'C0022983', 'cui_str': 'Laminectomy'}, {'cui': 'C0231448', 'cui_str': 'Extension'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",174.0,0.167345,"Secondary outcomes consist of pain intensity, self-perceived recovery, functional status measured with the Oswestry Disability Index and a physical examination.","[{'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Arjun Sharma', 'Affiliation': 'Neurosurgery, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Pravesh S', 'Initials': 'PS', 'LastName': 'Gadjradj', 'Affiliation': 'Neurosurgery, University Neurosurgical Center Holland, Leiden University Medical Center and The Hague Medical Center, Leiden, The Netherlands, Leiden, The Netherlands.'}, {'ForeName': 'Wilco C', 'Initials': 'WC', 'LastName': 'Peul', 'Affiliation': 'Neurosurgery, University Neurosurgical Center Holland, Leiden University Medical Center and The Hague Medical Center, Leiden, The Netherlands, Leiden, The Netherlands.'}, {'ForeName': 'Maurits W', 'Initials': 'MW', 'LastName': 'van Tulder', 'Affiliation': 'Health Sciences, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Wouter A', 'Initials': 'WA', 'LastName': 'Moojen', 'Affiliation': 'Neurosurgery, University Neurosurgical Center Holland, Leiden University Medical Center and The Hague Medical Center, Leiden, The Netherlands, Leiden, The Netherlands.'}, {'ForeName': 'Biswadjiet S', 'Initials': 'BS', 'LastName': 'Harhangi', 'Affiliation': 'Neurosurgery, Erasmus Medical Center, Rotterdam, The Netherlands b.s.harhangi@erasmusmc.nl.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2020-036818']
3211,33029828,A quasi-experimental study into the effects of naps and therapy glasses on fatigue and well-being.,"AIM


To investigate the effects of a napping facility and therapy glasses on fatigue and well-being at the end of the night shift.
BACKGROUND


Night shift work has adverse effects on fatigue and well-being.
METHODS


A quasi-experimental study was conducted, and data were collected on 243 night shifts of 95 nurses who had either access to a napping facility, therapy glasses, both facilities or no facilities. Multilevel analyses were conducted to predict fatigue and well-being.
RESULTS


Night shifts of nurses having access to both facilities were associated with less fatigue and more well-being. The use of therapy glasses related negatively to fatigue and positively to well-being. The use of the napping facility was not associated with fatigue and well-being. However, having slept while napping and sleeping time during napping were negatively associated with fatigue and positively associated with well-being.
CONCLUSION


Therapy glasses and sleeping in a napping facility can be effective interventions in reducing the adverse effects of night shift work.
IMPLICATIONS FOR NURSING MANAGEMENT


Therapy glasses seem an effective investment to facilitate the well-being of nurses. To enhance sleeping during napping, it is worthwhile to let nurses get accustomed to the napping facility and customize settings to personal preferences.",2020,The use of the napping facility was not associated with fatigue and well-being.,"['A quasi-experimental study was conducted and data was collected on 243 night shifts of 95 nurses who had either access to a napping facility, therapy glasses, both facilities, or no facilities']",['napping facility and therapy glasses'],[],"[{'cui': 'C2985410', 'cui_str': 'Controlled Clinical Trials, Non-Randomized'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}]","[{'cui': 'C0067518', 'cui_str': 'N-(4-aminophenethyl)spiroperidol'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}]",[],,0.0146329,The use of the napping facility was not associated with fatigue and well-being.,"[{'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'van Woerkom', 'Affiliation': 'Department of Human Resource Studies, Tilburg University, Tilburg, The Netherlands.'}]",Journal of nursing management,['10.1111/jonm.13172']
3212,33032778,"Economic Evaluation of Factorial Trials: Cost-Utility Analysis of the Atorvastatin in Factorial With Omega EE90 Risk Reduction in Diabetes 2 × 2 × 2 Factorial Trial of Atorvastatin, Omega-3 Fish Oil, and Action Planning.","OBJECTIVES


We applied principles for conducting economic evaluations of factorial trials to a trial-based economic evaluation of a cluster-randomized 2 × 2 × 2 factorial trial. We assessed the cost-effectiveness of atorvastatin, omega-3 fish oil, and an action-planning leaflet, alone and in combination, from a UK National Health Service perspective.
METHODS


The Atorvastatin in Factorial With Omega EE90 Risk Reduction in Diabetes (AFORRD) Trial randomized 800 patients with type 2 diabetes to atorvastatin, omega-3, or their respective placebos and randomized general practices to receive a leaflet-based action-planning intervention designed to improve compliance or standard care. The trial was conducted at 59 UK general practices. Sixteen-week outcomes for each trial participant were extrapolated for 70 years using the United Kingdom Prospective Diabetes Study Outcomes Model v2.01. We analyzed the trial as a 2 × 2 factorial trial (ignoring interactions between action-planning leaflet and medication), as a 2 × 2 × 2 factorial trial (considering all interactions), and ignoring all interactions.
RESULTS


We observed several qualitative interactions for costs and quality-adjusted life-years (QALYs) that changed treatment rankings. However, different approaches to analyzing the factorial design did not change the conclusions. There was a ≥99% chance that atorvastatin is cost-effective and omega-3 is not, at a £20 000/QALY threshold.
CONCLUSIONS


Atorvastatin monotherapy was the most cost-effective combination of the 3 trial interventions at a £20 000/QALY threshold. Omega-3 fish oil was not cost-effective, while there was insufficient evidence to draw firm conclusions about action planning. Recently-developed methods for analyzing factorial trials and combining parameter and sampling uncertainty were extended to estimate cost-effectiveness acceptability curves within a 2x2x2 factorial design with model-based extrapolation.",2020,"Omega-3 fish oil was not cost-effective, while there was insufficient evidence to draw firm conclusions about action planning.","['59 UK general practices', 'Diabetes', '800 patients with type 2 diabetes to']","['Omega-3 fish oil', 'atorvastatin, omega-3 fish oil', 'Atorvastatin', 'atorvastatin', 'Atorvastatin, Omega-3 Fish Oil, and Action Planning', 'Atorvastatin monotherapy', 'atorvastatin, omega-3, or their respective placebos and randomized general practices to receive a leaflet-based action-planning intervention designed to improve compliance or standard care']",[],"[{'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}]",[],800.0,0.0510697,"Omega-3 fish oil was not cost-effective, while there was insufficient evidence to draw firm conclusions about action planning.","[{'ForeName': 'Helen A', 'Initials': 'HA', 'LastName': 'Dakin', 'Affiliation': 'Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, England, UK. Electronic address: helen.dakin@ndph.ox.ac.uk.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Farmer', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, England, UK.'}, {'ForeName': 'Alastair M', 'Initials': 'AM', 'LastName': 'Gray', 'Affiliation': 'Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, England, UK.'}, {'ForeName': 'Rury R', 'Initials': 'RR', 'LastName': 'Holman', 'Affiliation': 'Diabetes Trials Unit, University of Oxford, Oxford, England, UK.'}]",Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research,['10.1016/j.jval.2020.05.018']
3213,33033021,Study protocol for a randomised controlled trial investigating two different refeeding formulations to improve safety and efficacy of hospital management of adolescent and young adults admitted with anorexia nervosa.,"INTRODUCTION


Providing effective nutritional rehabilitation to patients hospitalised with anorexia nervosa (AN) is challenging, partly due to conservative recommendations that advocate feeding patients at low energy intakes. An 'underfeeding syndrome' can develop when patients are not provided with adequate nutrition during treatment, whereby malnourished patients fail to restore weight in a timely matter, and even lose weight. Of particular concern, the reintroduction of carbohydrate in a starved patient can increase the risk of developing electrolyte, metabolic and organ dysfunction. The proposed trial assesses the efficacy and safety of a lower carbohydrate enteral formula (28% carbohydrate) against a standard enteral formula (54% carbohydrate), in adolescent and young adult patients (aged 15-25 years), hospitalised with AN.
METHODS AND ANALYSIS


The study employs a double-blind randomised controlled trial design. At admission to hospital, malnourished adolescent and young adults with AN will be randomly allocated to commence feeding on a standard enteral feeding formula (1.5 kcal/mL, 54% carbohydrate) or a lower carbohydrate isocaloric enteral feeding formula (1.5 kcal/mL, 28% carbohydrate). Assessments of nutritional intake, weight and biochemistry (phosphate, magnesium, potassium) will be conducted at baseline and during the first 3 weeks of hospital admission. The primary outcome measure will be incidence of hypophosphatemia. Secondary outcomes include weight gain, oedema, other electrolyte distortion, length of hospital admission, admission to the Intensive Care Unit (ICU) and number of days to reach medical stability, using defined parameters.
ETHICS AND DISSEMINATION


The protocol was approved by the Western Sydney Local Health District Human Research Ethics Committee and institutional research governance approvals were granted. Written informed consent will be sought prior to study enrolment. Study findings will be widely disseminated through peer-reviewed publications and conference presentations.
TRIAL REGISTRATION NUMBER


Australian New Zealand Clinical Trials Registry (ACTRN12617000342314); Pre-results.",2020,"Secondary outcomes include weight gain, oedema, other electrolyte distortion, length of hospital admission, admission to the Intensive Care Unit (ICU) and number of days to reach medical stability, using defined parameters.
","['patients hospitalised with anorexia nervosa (AN', 'adolescent and young adult patients (aged 15-25 years), hospitalised with AN', 'malnourished adolescent and young adults with AN', 'adolescent and young adults admitted with anorexia nervosa']","['lower carbohydrate enteral formula (28% carbohydrate) against a standard enteral formula (54% carbohydrate', 'hospital management', 'standard enteral feeding formula (1.5 kcal/mL, 54% carbohydrate) or a lower carbohydrate isocaloric enteral feeding formula']","['incidence of hypophosphatemia', 'efficacy and safety', 'safety and efficacy', 'weight gain, oedema, other electrolyte distortion, length of hospital admission, admission to the Intensive Care Unit (ICU) and number of days to reach medical stability, using defined parameters', 'nutritional intake, weight and biochemistry (phosphate, magnesium, potassium']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003125', 'cui_str': 'Anorexia nervosa'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]","[{'cui': 'C3714316', 'cui_str': 'Low carbohydrate enteral formula'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C3714326', 'cui_str': 'Standard enteral formula'}, {'cui': 'C0019948', 'cui_str': 'Administration, Hospital'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0086225', 'cui_str': 'Enteral feeding'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0560598', 'cui_str': 'kcal/mL'}, {'cui': 'C0205251', 'cui_str': 'Low'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0085682', 'cui_str': 'Hypophosphatemia'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0013832', 'cui_str': 'electrolytes'}, {'cui': 'C0030976', 'cui_str': 'Distortions, Perceptual'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005477', 'cui_str': 'Biochemistry'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}]",,0.109466,"Secondary outcomes include weight gain, oedema, other electrolyte distortion, length of hospital admission, admission to the Intensive Care Unit (ICU) and number of days to reach medical stability, using defined parameters.
","[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Parker', 'Affiliation': 'Department of Dietetics & Nutrition, Westmead Hospital, Westmead, New South Wales, Australia elizabeth.parker@health.nsw.gov.au.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Flood', 'Affiliation': 'Sydney School of Health Sciences, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Halaki', 'Affiliation': 'Sydney School of Health Sciences, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Wearne', 'Affiliation': 'Department of Medical Psychology, Westmead Hospital, Westmead, New South Wales, Australia.'}, {'ForeName': 'Gail', 'Initials': 'G', 'LastName': 'Anderson', 'Affiliation': 'Department of Adolescent & Young Adult Medicine, Westmead Hospital, Westmead, New South Wales, Australia.'}, {'ForeName': 'Linette', 'Initials': 'L', 'LastName': 'Gomes', 'Affiliation': 'Department of Adolescent & Young Adult Medicine, Westmead Hospital, Westmead, New South Wales, Australia.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Clarke', 'Affiliation': 'Department of Adolescent & Young Adult Medicine, Westmead Hospital, Westmead, New South Wales, Australia.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Wilson', 'Affiliation': 'Department of Psychiatry, Westmead Hospital, Westmead, New South Wales, Australia.'}, {'ForeName': 'Janice', 'Initials': 'J', 'LastName': 'Russell', 'Affiliation': 'Sydney School of Medicine, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Frig', 'Affiliation': 'Department of Nutrition and Dietetics, Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kohn', 'Affiliation': 'Department of Adolescent & Young Adult Medicine, Westmead Hospital, Westmead, New South Wales, Australia.'}]",BMJ open,['10.1136/bmjopen-2020-038242']
3214,33033025,Exercise in older women with breast cancer during systemic therapy: study protocol of a randomised controlled trial (BREACE).,"INTRODUCTION


Exercise interventions have been widely investigated in patients with cancer and demonstrate beneficial effects. However, intervention studies that include older women with breast cancer exercising during medical treatment are scarce. Hence, the aim of this study is to investigate the effect of a 12-week exercise-based intervention in older women (≥65 years) with breast cancer receiving (neo)adjuvant or first-line or second-line systemic therapy.
METHODS AND ANALYSIS


This is a single-centre, two-armed randomised controlled trial. We anticipate including 100 patients, who will be randomised 1:1 to exercise-based intervention or control stratified by treatment setting ((neo)adjuvant or metastatic) and treatment (chemotherapy or endocrine therapy + cyclin-dependent kinase (CDK) 4/6 inhibitors). The intervention group will receive standard oncological treatment and a 12-week supervised exercise-based intervention comprising a progressive resistance exercise programme two times per week, a protein supplement after exercise and a home-based walking programme based on daily step counts. The control group will receive standard oncological treatment. Assessments will be performed at baseline and 6, 12 and 24 weeks after start of the intervention. Primary outcome is physical function, measured by the 30-second Chair Stand Test. Secondary outcomes are feasibility (compliance and adherence to intervention), objective and patient-reported functional measures (6-meter and 10-meter gait speed; 6-min Walk Test; Handgrip Strength; Stair Climb Test; Physical Activity Questionnaire), symptom burden and well-being (MD Anderson Symptom Inventory; Hospital Anxiety and Depression Scale), quality of life (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 and B23), body composition (dual-energy X-ray absorptiometry scan), side effects, inflammatory biomarkers, hospitalisation and survival.
ETHICS AND DISSEMINATION


The protocol was reviewed and accepted by the Scientific Ethics Review Committee of the Capital Region of Denmark, 17 June 2018 (VEK ref.: H-18021013). Trial results will be submitted for publication in a peer-reviewed journal and presented on conferences, in oncology wards, exercise centres in municipalities and patient organisations, ensuring dissemination to relevant stakeholders.
TRIAL REGISTRATION NUMBER


https://clinicaltrials.gov/ on 3 September 2018. Identifier: NCT03656731.",2020,"We anticipate including 100 patients, who will be randomised 1:1 to exercise-based intervention or control stratified by treatment setting ((neo)adjuvant or metastatic) and treatment (chemotherapy or endocrine therapy + cyclin-dependent kinase (CDK) 4/6 inhibitors).","['older women with breast cancer during systemic therapy', 'older women with breast cancer', '100 patients', 'older women (≥65 years) with breast cancer receiving (neo)adjuvant or first-line or second-line systemic therapy', 'patients with cancer']","['standard oncological treatment', 'exercise-based intervention or control stratified by treatment setting ((neo)adjuvant or metastatic) and treatment (chemotherapy or endocrine therapy + cyclin-dependent kinase (CDK) 4/6 inhibitors', 'standard oncological treatment and a 12-week supervised exercise-based intervention comprising a progressive resistance exercise programme two times per week, a protein supplement after exercise and a home-based walking programme based on daily step counts', 'exercise-based intervention', 'Exercise']","['feasibility (compliance and adherence to intervention), objective and patient-reported functional measures (6-meter and 10-meter gait speed; 6-min Walk Test; Handgrip Strength; Stair Climb Test; Physical Activity Questionnaire), symptom burden and well-being (MD Anderson Symptom Inventory; Hospital Anxiety and Depression Scale), quality of life (European Organization for Research and Treatment of', 'Cancer Quality of Life Questionnaire Core-30 and B23), body composition (dual-energy X-ray absorptiometry scan), side effects, inflammatory biomarkers, hospitalisation and survival', 'physical function, measured by the 30-second Chair Stand Test']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C0243045', 'cui_str': 'cdk Proteins'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0038164', 'cui_str': 'Protein A'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439157', 'cui_str': 'counts'}]","[{'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0456965', 'cui_str': '20 feet'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0432601', 'cui_str': 'Stairs climbed'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}]",,0.148979,"We anticipate including 100 patients, who will be randomised 1:1 to exercise-based intervention or control stratified by treatment setting ((neo)adjuvant or metastatic) and treatment (chemotherapy or endocrine therapy + cyclin-dependent kinase (CDK) 4/6 inhibitors).","[{'ForeName': 'Høgni Hammershaimb', 'Initials': 'HH', 'LastName': 'Andersen', 'Affiliation': 'Department of Physiotherapy and Occupational Therapy, Herlev and Gentofte University Hospital, Herlev, Denmark hoegni.hammershaimb.andersen@regionh.dk.'}, {'ForeName': 'Marta Kramer', 'Initials': 'MK', 'LastName': 'Mikkelsen', 'Affiliation': 'Department of Oncology, Herlev and Gentofte University Hospital, Herlev, Denmark.'}, {'ForeName': 'Ida', 'Initials': 'I', 'LastName': 'Lundager', 'Affiliation': 'Department of Physiotherapy and Occupational Therapy, Herlev and Gentofte University Hospital, Herlev, Denmark.'}, {'ForeName': 'Cecilia Margareta', 'Initials': 'CM', 'LastName': 'Lund', 'Affiliation': 'Department of Medicine, Herlev and Gentofte University Hospital, Herlev, Denmark.'}, {'ForeName': 'Julia Sidenius', 'Initials': 'JS', 'LastName': 'Johansen', 'Affiliation': 'Department of Oncology, Herlev and Gentofte University Hospital, Herlev, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Vinther', 'Affiliation': 'Department of Physiotherapy and Occupational Therapy, Herlev and Gentofte University Hospital, Herlev, Denmark.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Bogh Juhl', 'Affiliation': 'Department of Physiotherapy and Occupational Therapy, Herlev and Gentofte University Hospital, Hellerup, Denmark.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Zerahn', 'Affiliation': 'Department of Clinical Physiology and Nuclear Medicine, Herlev and Gentofte Hospital, University of Copenhagen, Herlev, Denmark.'}, {'ForeName': 'Anne-Mette', 'Initials': 'AM', 'LastName': 'Ragle', 'Affiliation': 'Department of Physiotherapy and Occupational Therapy, Herlev and Gentofte University Hospital, Herlev, Denmark.'}, {'ForeName': 'Dorte Lisbet', 'Initials': 'DL', 'LastName': 'Nielsen', 'Affiliation': 'Department of Oncology, Herlev and Gentofte University Hospital, Herlev, Denmark.'}]",BMJ open,['10.1136/bmjopen-2020-038674']
3215,33033029,"Strengthening integration of chronic care in Africa: protocol for the qualitative process evaluation of integrated HIV, diabetes and hypertension care in a cluster randomised controlled trial in Tanzania and Uganda.","INTRODUCTION


In sub-Saharan Africa, the burden of non-communicable diseases (NCDs), particularly diabetes mellitus (DM) and hypertension, has increased rapidly in recent years, although HIV infection remains a leading cause of death among young-middle-aged adults. Health service coverage for NCDs remains very low in contrast to HIV, despite the increasing prevalence of comorbidity of NCDs with HIV. There is an urgent need to expand healthcare capacity to provide integrated services to address these chronic conditions.
METHODS AND ANALYSIS


This protocol describes procedures for a qualitative process evaluation of INTE-AFRICA, a cluster randomised trial comparing integrated health service provision for HIV infection, DM and hypertension, to the current stand-alone vertical care. Interviews, focus group discussions and observations of consultations and other care processes in two clinics (in Tanzania, Uganda) will be used to explore the experiences of stakeholders. These stakeholders will include health service users, policy-makers, healthcare providers, community leaders and members, researchers, non-governmental and international organisations. The exploration will be carried out during the implementation of the project, alongside an understanding of the impact of broader structural and contextual factors.
ETHICS AND DISSEMINATION


Ethical approval was granted by the Liverpool School of Tropical Medicine (UK), the National Institute of Medical Research (Tanzania) and TASO Research Ethics Committee (Uganda) in 2020. The evaluation will provide the opportunity to document the implementation of integration over several timepoints (6, 12 and 18 months) and refine integrated service provision prior to scale up. This synergistic approach to evaluate, understand and respond will support service integration and inform monitoring, policy and practice development efforts to involve and educate communities in Tanzania and Uganda. It will create a model of care and a platform of good practices and lessons learnt for other countries implementing integrated and decentralised community health services.
TRIAL REGISTRATION NUMBER


ISRCTN43896688; Pre-results.",2020,"Health service coverage for NCDs remains very low in contrast to HIV, despite the increasing prevalence of comorbidity of NCDs with HIV.",['young-middle-aged adults'],[],[],"[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]",[],[],,0.0648707,"Health service coverage for NCDs remains very low in contrast to HIV, despite the increasing prevalence of comorbidity of NCDs with HIV.","[{'ForeName': 'Marie-Claire', 'Initials': 'MC', 'LastName': 'Van Hout', 'Affiliation': 'Public Health Institute, Liverpool John Moores University, Liverpool, Merseyside, UK M.C.VanHout@ljmu.ac.uk.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Bachmann', 'Affiliation': 'Norwich Medical School, University of East Anglia Faculty of Medicine and Health Sciences, Norwich, UK.'}, {'ForeName': 'Jeffrey V', 'Initials': 'JV', 'LastName': 'Lazarus', 'Affiliation': 'Barcelona Institute for Global Health (ISGlobal), Hospital Clinic, University of Barcelona, Barcelona, Catalunya, Spain.'}, {'ForeName': 'Elizabeth Henry', 'Initials': 'EH', 'LastName': 'Shayo', 'Affiliation': 'Muhimbili Centre, National Institute for Medical Research, Dar es Salaam, Dar es Salaam, Tanzania, United Republic of.'}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'Bukenya', 'Affiliation': 'MRC/UVRI/LSHTM Uganda Research Unit, Medical Research Council Uganda, Entebbe, Uganda.'}, {'ForeName': 'Camila A', 'Initials': 'CA', 'LastName': 'Picchio', 'Affiliation': 'Barcelona Institute for Global Health (ISGlobal), Hospital Clinic, University of Barcelona, Barcelona, Catalunya, Spain.'}, {'ForeName': 'Moffat', 'Initials': 'M', 'LastName': 'Nyirenda', 'Affiliation': 'MRC/UVRI/LSHTM Uganda Research Unit, Medical Research Council Uganda, Entebbe, Uganda.'}, {'ForeName': 'Sayoki Godfrey', 'Initials': 'SG', 'LastName': 'Mfinanga', 'Affiliation': 'Muhimbili Centre, National Institute for Medical Research, Dar es Salaam, Dar es Salaam, Tanzania, United Republic of.'}, {'ForeName': 'Josephine', 'Initials': 'J', 'LastName': 'Birungi', 'Affiliation': 'MRC/UVRI/LSHTM Uganda Research Unit, Medical Research Council Uganda, Entebbe, Uganda.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Okebe', 'Affiliation': 'Department of International Public Health, Liverpool School of Tropical Medicine, Liverpool, Liverpool, UK.'}, {'ForeName': 'Shabbar', 'Initials': 'S', 'LastName': 'Jaffar', 'Affiliation': 'Department of International Public Health, Liverpool School of Tropical Medicine, Liverpool, Liverpool, UK.'}]",BMJ open,['10.1136/bmjopen-2020-039237']
3216,33033035,"Bilateral Remote Ischaemic Conditioning in Children (BRICC) trial: protocol for a two-centre, double-blind, randomised controlled trial in young children undergoing cardiac surgery.","INTRODUCTION


Myocardial protection against ischaemic-reperfusion injury is a key determinant of heart function and outcome following cardiac surgery in children. However, with current strategies, myocardial injury occurs routinely following aortic cross-clamping, as demonstrated by the ubiquitous rise in circulating troponin. Remote ischaemic preconditioning, the application of brief, non-lethal cycles of ischaemia and reperfusion to a distant organ or tissue, is a simple, low-risk and readily available technique which may improve myocardial protection. The Bilateral Remote Ischaemic Conditioning in Children (BRICC) trial will assess whether remote ischaemic preconditioning, applied to both lower limbs immediately prior to surgery, reduces myocardial injury in cyanotic and acyanotic young children.
METHODS AND ANALYSIS


The BRICC trial is a two-centre, double-blind, randomised controlled trial recruiting up to 120 young children (age 3 months to 3 years) undergoing primary repair of tetralogy of Fallot or surgical closure of an isolated ventricular septal defect. Participants will be randomised in a 1:1 ratio to either bilateral remote ischaemic preconditioning (3×5 min cycles) or sham immediately prior to surgery, with follow-up until discharge from hospital or 30 days, whichever is sooner. The primary outcome is reduction in area under the time-concentration curve for high-sensitivity (hs) troponin-T release in the first 24 hours after aortic cross-clamp release. Secondary outcome measures include peak hs-troponin-T, vasoactive inotrope score, arterial lactate and central venous oxygen saturations in the first 12 hours, and lengths of stay in the paediatric intensive care unit and the hospital.
ETHICS AND DISSEMINATION


The trial was approved by the West Midlands-Solihull National Health Service Research Ethics Committee (16/WM/0309) on 5 August 2016. Findings will be disseminated to the academic community through peer-reviewed publications and presentation at national and international meetings. Parents will be informed of the results through a newsletter in conjunction with a local charity.
TRIAL REGISTRATION NUMBER


ISRCTN12923441.",2020,"The BRICC trial is a two-centre, double-blind, randomised controlled trial recruiting up to 120 young children (age 3 months to 3 years) undergoing primary repair of tetralogy of Fallot or surgical closure of an isolated ventricular septal defect.","['cardiac surgery in children', '120 young children (age 3 months to 3 years) undergoing primary repair of tetralogy of Fallot or surgical closure of an isolated ventricular septal defect', 'cyanotic and acyanotic young children', 'young children undergoing cardiac surgery']","['Bilateral Remote Ischaemic Conditioning', 'bilateral remote ischaemic preconditioning (3×5\u2009min cycles) or sham immediately prior to surgery']","['reduction in area under the time-concentration curve for high-sensitivity (hs) troponin-T release', 'peak hs-troponin-T, vasoactive inotrope score, arterial lactate and central venous oxygen saturations in the first 12\u2009hours, and lengths of stay in the paediatric intensive care unit and the hospital']","[{'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0397326', 'cui_str': 'Repair of tetralogy of Fallot'}, {'cui': 'C0185003', 'cui_str': 'Closure'}, {'cui': 'C0018818', 'cui_str': 'Ventricular septal defect'}, {'cui': 'C0332580', 'cui_str': 'Cyanotic'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0077404', 'cui_str': 'Troponin T'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0444466', 'cui_str': 'Central venous'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C1292430', 'cui_str': '12 hours'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0021710', 'cui_str': 'Pediatric intensive care unit'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]",120.0,0.543449,"The BRICC trial is a two-centre, double-blind, randomised controlled trial recruiting up to 120 young children (age 3 months to 3 years) undergoing primary repair of tetralogy of Fallot or surgical closure of an isolated ventricular septal defect.","[{'ForeName': 'Nigel E', 'Initials': 'NE', 'LastName': 'Drury', 'Affiliation': ""Paediatric Cardiac Surgery, Birmingham Children's Hospital, Birmingham, West Midlands, UK n.e.drury@bham.ac.uk.""}, {'ForeName': 'Rehana', 'Initials': 'R', 'LastName': 'Bi', 'Affiliation': ""Paediatric Cardiac Surgery, Birmingham Children's Hospital, Birmingham, West Midlands, UK.""}, {'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Woolley', 'Affiliation': 'Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, West Midlands, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Stickley', 'Affiliation': ""Paediatric Cardiac Surgery, Birmingham Children's Hospital, Birmingham, West Midlands, UK.""}, {'ForeName': 'Kevin P', 'Initials': 'KP', 'LastName': 'Morris', 'Affiliation': ""Paediatric Intensive Care, Birmingham Children's Hospital, Birmingham, West Midlands, UK.""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Montgomerie', 'Affiliation': ""Paediatric Cardiac Anaesthesia, Birmingham Children's Hospital, Birmingham, West Midlands, UK.""}, {'ForeName': 'Carin', 'Initials': 'C', 'LastName': 'van Doorn', 'Affiliation': 'Congenital Cardiac Surgery, Leeds Teaching Hospitals NHS Trust, Leeds, West Yorkshire, UK.'}, {'ForeName': 'Warwick B', 'Initials': 'WB', 'LastName': 'Dunn', 'Affiliation': 'School of Biosciences, University of Birmingham, Birmingham, West Midlands, UK.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Madhani', 'Affiliation': 'Institute of Cardiovascular Sciences, University of Birmingham, Birmingham, West Midlands, UK.'}, {'ForeName': 'Natalie J', 'Initials': 'NJ', 'LastName': 'Ives', 'Affiliation': 'Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, West Midlands, UK.'}, {'ForeName': 'Paulus', 'Initials': 'P', 'LastName': 'Kirchhof', 'Affiliation': 'Institute of Cardiovascular Sciences, University of Birmingham, Birmingham, West Midlands, UK.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Jones', 'Affiliation': ""Paediatric Cardiac Surgery, Birmingham Children's Hospital, Birmingham, West Midlands, UK.""}]",BMJ open,['10.1136/bmjopen-2020-042176']
3217,33031472,Volar locking plate versus external fixation for unstable dorsally displaced distal radius fractures-A 3-year cost-utility analysis.,"AIM


To investigate the cost-effectiveness of Volar Locking Plate (VLP) compared to External Fixation (EF) for unstable dorsally displaced distal radius fractures in a 3-year perspective.
METHODS


During 2009-2013, patients aged 50-74 years with an unstable dorsally displaced distal radius fracture were randomised to VLP or EF. Primary outcome was the incremental cost-effectiveness ratio (ICER) for VLP compared with EF. Data regarding health effects (Quality-adjusted life years, QALYs) was prospectively collected during the trial period until 3 years after surgery. Cost data was collected retrospectively for the same time period and included direct and indirect costs (production loss).
RESULTS


One hundred and thirteen patients (VLP n = 58, EF n = 55) had complete data until 3 years and were used in the analysis. At one year, the VLP group had a mean incremental cost of 878 euros and a gain of 0.020 QALYs compared with the EF group, rendering an ICER of 43 900 euros per QALY. At three years, the VLP group had a mean incremental cost of 1 082 euros and a negative incremental effect of -0.005 QALYs compared to the EF group, which means that VLP was dominated by EF. The probability that VLP was cost-effective compared to EF at three years, was lower than 50% independent of the willingness to pay per QALY.
CONCLUSION


Three years after distal radius fracture surgery, VLP fixation resulted in higher costs and a smaller effect in QALYs compared to EF. Our results indicate that it is uncertain if VLP is a cost-effective treatment of unstable distal radius fractures compared to EF.",2020,"CONCLUSION


Three years after distal radius fracture surgery, VLP fixation resulted in higher costs and a smaller effect in QALYs compared to EF.","['One hundred and thirteen patients (VLP n = 58, EF n = 55) had complete data until 3 years and were used in the analysis', 'During 2009-2013, patients aged 50-74 years with an unstable dorsally displaced distal radius fracture']","['Volar locking plate versus external fixation', 'VLP or EF', 'Volar Locking Plate (VLP', 'VLP fixation', 'External Fixation (EF']","['direct and indirect costs (production loss', 'mean incremental cost', 'incremental cost-effectiveness ratio (ICER']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443349', 'cui_str': 'Volar'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0407333', 'cui_str': 'External skeletal fixation procedure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0443343', 'cui_str': 'Unstable status'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}]","[{'cui': 'C0443349', 'cui_str': 'Volar'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0407333', 'cui_str': 'External skeletal fixation procedure'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}]","[{'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0439852', 'cui_str': 'Indirect'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",,0.0428792,"CONCLUSION


Three years after distal radius fracture surgery, VLP fixation resulted in higher costs and a smaller effect in QALYs compared to EF.","[{'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Saving', 'Affiliation': 'Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Emelie', 'Initials': 'E', 'LastName': 'Heintz', 'Affiliation': 'Department of Learning, Informatics, Management and Ethics (LIME), Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Pettersson', 'Affiliation': 'Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Enocson', 'Affiliation': 'Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Mellstrand Navarro', 'Affiliation': 'Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, Stockholm, Sweden.'}]",PloS one,['10.1371/journal.pone.0240377']
3218,33031491,Transcatheter Aortic Valve Replacement in Low-risk Patients With Bicuspid Aortic Valve Stenosis.,"Importance


The outcomes of transcatheter aortic valve replacement (TAVR) in low-risk patients with bicuspid aortic valve stenosis have not been studied in a large scale, multicentered, prospective fashion.
Objective


To evaluate the procedural safety, efficacy, and 30-day outcomes of TAVR in patients with bicuspid aortic stenosis at low surgical risk.
Design, Setting, and Participants


The Low Risk Bicuspid Study is a prospective, single-arm trial study with inclusion/exclusion criteria developed from the Evolut Low Risk Randomized Trial. Follow-up is planned for 10 years. Patients underwent TAVR at 25 centers in the United States who were also participating in the Evolut Low Risk Randomized Trial from December 2018 to October 2019. Eligible patients had severe bicuspid aortic valve stenosis and met American Heart Association/American College of Cardiology guideline indications for aortic valve replacement.
Interventions


Patients underwent attempted implant of an Evolut or Evolut PRO transcatheter aortic valve, with valve size based on annular measurements.
Main Outcomes and Measures


The prespecified primary end point was the incidence of all-cause mortality or disabling stroke at 30 days. The prespecified primary efficacy end point was device success defined as the absence of procedural mortality, the correct position of 1 bioprosthetic heart valve in the proper anatomical location, and the absence of more than mild aortic regurgitation postprocedure.
Results


A total of 150 patients underwent an attempted implant. Baseline characteristics include mean age of 70.3 (5.5) years, 48.0% female (n = 72), and a mean Society of Thoracic Surgeons score of 1.4 (0.6%). Most patients (136; 90.7%) had Sievers type I valve morphology. The incidence of all-cause mortality or disabling stroke was 1.3% (95% CI, 0.3%-5.3%) at 30 days. The device success rate was 95.3% (95% CI, 90.5%-98.1%). At 30 days, the mean (SD) AV gradient was 7.6 (3.7) mm Hg and effective orifice area was 2.3 (0.7) cm2. A new permanent pacemaker was implanted in 22 patients (15.1%). No patients had greater than mild paravalvular leak.
Conclusions and Relevance


Transcatheter aortic valve replacement in low-surgical risk patients with bicuspid aortic valve stenosis achieved favorable 30-day results, with low rates of death and stroke and high device success rate.
Trial Registration


ClinicalTrials.gov Identifier: NCT03635424.",2020,"The device success rate was 95.3% (95% CI, 90.5%-98.1%).","['150 patients underwent an attempted implant', 'Patients underwent TAVR at 25 centers in the United States who were also participating in the Evolut Low Risk Randomized Trial from December 2018 to October 2019', 'patients with bicuspid aortic stenosis at low surgical risk', 'Eligible patients had severe bicuspid aortic valve stenosis and met American Heart Association/American College of Cardiology guideline indications for aortic valve replacement', 'mean age of 70.3 (5.5) years, 48.0% female (n\u2009=\u200972), and a mean Society of Thoracic Surgeons score of 1.4 (0.6', 'low-surgical risk patients with bicuspid aortic valve stenosis', 'Most patients (136; 90.7%) had Sievers type', 'low-risk patients with bicuspid aortic valve stenosis', 'Low-risk Patients With Bicuspid Aortic Valve Stenosis']","['implant of an Evolut or Evolut PRO transcatheter aortic valve, with valve size based on annular measurements', 'TAVR', 'Transcatheter Aortic Valve Replacement', 'Transcatheter aortic valve replacement', 'transcatheter aortic valve replacement (TAVR']","['procedural safety, efficacy', 'incidence of all-cause mortality or disabling stroke', 'mean (SD) AV gradient', 'device success defined as the absence of procedural mortality, the correct position of 1 bioprosthetic heart valve in the proper anatomical location, and the absence of more than mild aortic regurgitation postprocedure', 'device success rate', 'mild paravalvular leak']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C2711836', 'cui_str': 'Percutaneous replacement of aortic valve using fluoroscopic guidance'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0005373', 'cui_str': 'Bicuspid'}, {'cui': 'C0003507', 'cui_str': 'Aortic valve stenosis'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0149630', 'cui_str': 'Bicuspid aortic valve'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0002458', 'cui_str': 'American Heart Association'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0003506', 'cui_str': 'Replacement of aortic valve'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0278626', 'cui_str': 'Thoracic surgeon'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4517503', 'cui_str': '1.4'}, {'cui': 'C4068883', 'cui_str': '0.6'}, {'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0442343', 'cui_str': 'Transcatheter approach'}, {'cui': 'C0003501', 'cui_str': 'Aortic valve structure'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0521164', 'cui_str': 'Annular shape'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C2711836', 'cui_str': 'Percutaneous replacement of aortic valve using fluoroscopic guidance'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0018825', 'cui_str': 'Cardiac valve prosthesis'}, {'cui': 'C0923870', 'cui_str': 'Anatomical location (property)'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0003504', 'cui_str': 'Aortic valve regurgitation'}, {'cui': 'C1709508', 'cui_str': 'Paravalvular leak'}]",150.0,0.0773092,"The device success rate was 95.3% (95% CI, 90.5%-98.1%).","[{'ForeName': 'John K', 'Initials': 'JK', 'LastName': 'Forrest', 'Affiliation': 'Departments of Internal Medicine (Cardiology) and Surgery (Cardiac Surgery), Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Basel', 'Initials': 'B', 'LastName': 'Ramlawi', 'Affiliation': 'Department of Cardiothoracic Surgery and Cardiology, Valley Health System, Winchester, Virginia.'}, {'ForeName': 'G Michael', 'Initials': 'GM', 'LastName': 'Deeb', 'Affiliation': 'Departments of Cardiac Surgery and Interventional Cardiology, University of Michigan Hospitals, Ann Arbor.'}, {'ForeName': 'Firas', 'Initials': 'F', 'LastName': 'Zahr', 'Affiliation': 'Departments of Interventional Cardiology and Cardiothoracic Surgery, Oregon Health and Science University, Portland.'}, {'ForeName': 'Howard K', 'Initials': 'HK', 'LastName': 'Song', 'Affiliation': 'Departments of Interventional Cardiology and Cardiothoracic Surgery, Oregon Health and Science University, Portland.'}, {'ForeName': 'Neal S', 'Initials': 'NS', 'LastName': 'Kleiman', 'Affiliation': 'Departments of Interventional Cardiology and Cardiothoracic Surgery, Houston Methodist DeBakey Heart and Vascular Institute, Houston, Texas.'}, {'ForeName': 'Stanley J', 'Initials': 'SJ', 'LastName': 'Chetcuti', 'Affiliation': 'Departments of Cardiac Surgery and Interventional Cardiology, University of Michigan Hospitals, Ann Arbor.'}, {'ForeName': 'Hector I', 'Initials': 'HI', 'LastName': 'Michelena', 'Affiliation': 'Division of Cardiovascular Ultrasound, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Abeel A', 'Initials': 'AA', 'LastName': 'Mangi', 'Affiliation': 'Departments of Internal Medicine (Cardiology) and Surgery (Cardiac Surgery), Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Skiles', 'Affiliation': 'Department of Cardiothoracic Surgery and Cardiology, Valley Health System, Winchester, Virginia.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Department of Statistics, Medtronic, Minneapolis, Minnesota.'}, {'ForeName': 'Jeffrey J', 'Initials': 'JJ', 'LastName': 'Popma', 'Affiliation': 'Department of Interventional Cardiology, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Reardon', 'Affiliation': 'Departments of Interventional Cardiology and Cardiothoracic Surgery, Houston Methodist DeBakey Heart and Vascular Institute, Houston, Texas.'}]",JAMA cardiology,['10.1001/jamacardio.2020.4738']
3219,33031534,Effect of Passive Choice and Active Choice Interventions in the Electronic Health Record to Cardiologists on Statin Prescribing: A Cluster Randomized Clinical Trial.,"Importance


Statin therapy is underused for many patients who could benefit.
Objective


To evaluate the effect of passive choice and active choice interventions in the electronic health record (EHR) to promote guideline-directed statin therapy.
Design, Setting, and Participants


Three-arm randomized clinical trial with a 6-month preintervention period and 6-month intervention. Randomization conducted at the cardiologist level at 16 cardiology practices in Pennsylvania and New Jersey. The study included 82 cardiologists and 11 693 patients. Data were analyzed between May 8, 2019, and January 9, 2020.
Interventions


In passive choice, cardiologists had to manually access an alert embedded in the EHR to select options to initiate or increase statin therapy. In active choice, an interruptive EHR alert prompted the cardiologist to accept or decline guideline-directed statin therapy. Cardiologists in the control group were informed of the trial but received no other interventions.
Main Outcomes and Measures


Primary outcome was statin therapy at optimal dose based on clinical guidelines. Secondary outcome was statin therapy at any dose.
Results


The sample comprised 11 693 patients with a mean (SD) age of 63.8 (9.1) years; 58% were male (n = 6749 of 11 693), 66% were White (n = 7683 of 11 693), and 24% were Black (n = 2824 of 11 693). The mean (SD) 10-year atherosclerotic cardiovascular disease (ASCVD) risk score was 15.4 (10.0); 68% had an ASVCD clinical diagnosis. Baseline statin prescribing rates at the optimal dose were 40.3% in the control arm, 39.1% in the passive choice arm, and 41.2% in the active choice arm. In adjusted analyses, the change in statin prescribing rates at optimal dose over time was not significantly different from control for passive choice (adjusted difference in percentage points, 0.2; 95% CI, -2.9 to 2.8; P = .86) or active choice (adjusted difference in percentage points, 2.4; 95% CI, -0.6 to 5.0; P = .08). In adjusted analyses of the subset of patients with clinical ASCVD, the active choice intervention resulted in a significant increase in statin prescribing at optimal dose relative to control (adjusted difference in percentage points, 3.8; 95% CI, 1.0-6.4; P = .008). No other subset analyses were significant. There were no significant changes in statin prescribing at any dose for either intervention.
Conclusions and Relevance


The passive choice and active choice interventions did not change statin prescribing. In the subgroup of patients with clinical ASCVD, the active choice intervention led to a small increase in statin prescribing at the optimal dose, which could inform the design or targeting of future interventions.
Trial Registration


ClinicalTrials.gov Identifier: NCT03271931.",2020,"In adjusted analyses, the change in statin prescribing rates at optimal dose over time was not significantly different from control for passive choice (adjusted difference in percentage points, 0.2; 95% CI, -2.9 to 2.8; P = .86) or active choice (adjusted difference in percentage points, 2.4; 95% CI, -0.6 to 5.0; P = .08).","['16 cardiology practices in Pennsylvania and New Jersey', 'many patients who could benefit', '693 patients with a mean (SD) age of 63.8 (9.1) years; 58% were male (n\u2009=\u20096749 of 11\u202f693), 66% were White (n\u2009=\u20097683 of 11\u202f693), and 24% were Black (n\u2009=\u20092824 of 11\u202f693', '82 cardiologists and 11\u202f693 patients']","['Passive Choice and Active Choice Interventions', 'passive choice and active choice interventions']","['change in statin prescribing rates', 'Baseline statin prescribing rates', 'mean (SD) 10-year atherosclerotic cardiovascular disease (ASCVD) risk score', 'statin prescribing']","[{'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0030853', 'cui_str': 'Pennsylvania'}, {'cui': 'C0027971', 'cui_str': 'New Jersey'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0175906', 'cui_str': 'Cardiologist'}]","[{'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",11693.0,0.266019,"In adjusted analyses, the change in statin prescribing rates at optimal dose over time was not significantly different from control for passive choice (adjusted difference in percentage points, 0.2; 95% CI, -2.9 to 2.8; P = .86) or active choice (adjusted difference in percentage points, 2.4; 95% CI, -0.6 to 5.0; P = .08).","[{'ForeName': 'Srinath', 'Initials': 'S', 'LastName': 'Adusumalli', 'Affiliation': 'Penn Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Julie E', 'Initials': 'JE', 'LastName': 'Westover', 'Affiliation': 'Penn Medicine Nudge Unit, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Douglas S', 'Initials': 'DS', 'LastName': 'Jacoby', 'Affiliation': 'Penn Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Dylan S', 'Initials': 'DS', 'LastName': 'Small', 'Affiliation': 'Wharton School, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'VanZandbergen', 'Affiliation': 'Penn Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Penn Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Ann M', 'Initials': 'AM', 'LastName': 'Cavella', 'Affiliation': 'Penn Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Pepe', 'Affiliation': 'Penn Medicine Nudge Unit, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Charles A L', 'Initials': 'CAL', 'LastName': 'Rareshide', 'Affiliation': 'Penn Medicine Nudge Unit, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Christopher K', 'Initials': 'CK', 'LastName': 'Snider', 'Affiliation': 'Penn Medicine Nudge Unit, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Kevin G', 'Initials': 'KG', 'LastName': 'Volpp', 'Affiliation': 'Penn Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Asch', 'Affiliation': 'Penn Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Mitesh S', 'Initials': 'MS', 'LastName': 'Patel', 'Affiliation': 'Penn Medicine, University of Pennsylvania, Philadelphia.'}]",JAMA cardiology,['10.1001/jamacardio.2020.4730']
3220,33044494,Concordance Between Blood Pressure in the Systolic Blood Pressure Intervention Trial and in Routine Clinical Practice.,"Importance


There are concerns with translating results from the Systolic Blood Pressure Intervention Trial (SPRINT) into clinical practice because the standardized protocol used to measure blood pressure (BP) may not be consistently applied in routine clinical practice.
Objectives


To evaluate the concordance between BPs obtained in routine clinical practice and those obtained using the SPRINT protocol and whether concordance varied by target trial BP.
Design, Setting, and Participants


This observational prognostic study linking outpatient vital sign information from electronic health records (EHRs) with data from 49 of the 102 SPRINT sites was conducted from November 8, 2010, to August 20, 2015, among 3074 adults 50 years or older with hypertension without diabetes or a history of stroke. Statistical analysis was performed from May 21, 2019, to March 20, 2020.
Main Outcomes and Measures


Blood pressures measured in routine clinical practice and SPRINT.
Results


Participant-level EHR data was obtained for 3074 participants (2482 men [80.7%]; mean [SD] age, 68.5 [9.1] years) with 3 or more outpatient and trial BP measurements. In the period from the 6-month study visit to the end of the study intervention, the mean systolic BP (SBP) in the intensive treatment group from outpatient BP recorded in the EHR was 7.3 mm Hg higher (95% CI, 7.0-7.6 mm Hg) than BP measured at trial visits; the mean difference between BP recorded in the outpatient EHR and trial SBP was smaller for participants in the standard treatment group (4.6 mm Hg [95% CI, 4.4-4.9 mm Hg]). Bland-Altman analyses demonstrated low agreement between outpatient BP recorded in the EHR and trial BP, with wide agreement intervals ranging from approximately -30 mm Hg to 45 mm Hg in both treatment groups. In addition, the difference between BP recorded in the EHR and trial BP varied widely by site.
Conclusions and Relevance


Outpatient BPs measured in routine clinical practice were generally higher than BP measurements taken in SPRINT, with greater mean SBP differences apparent in the intensive treatment group. There was a consistent high degree of heterogeneity between the BPs recorded in the EHR and trial BPs, with significant variability over time, between and within the participants, and across clinic sites. These results highlight the importance of proper BP measurement technique and an inability to apply 1 common correction factor (ie, approximately 10 mm Hg) to approximate research-quality BP estimates when BP is not measured appropriately in routine clinical practice.
Trial Registration


SPRINT ClinicalTrials.gov Identifier: NCT01206062.",2020,"SBP was smaller for participants in the standard treatment group (4.6 mm Hg [95% CI, 4.4-4.9 mm Hg]).","['3074 participants (2482 men [80.7%]; mean [SD] age, 68.5 [9.1] years) with 3 or more outpatient and trial BP measurements', 'outpatient vital sign information from electronic health records (EHRs) with data from 49 of the 102 SPRINT sites was conducted from November 8, 2010, to August 20, 2015, among 3074 adults 50 years or older with hypertension without diabetes or a history of stroke']",[],"['Measures\n\n\nBlood pressures measured in routine clinical practice and SPRINT', 'blood pressure (BP', 'mean systolic BP (SBP', 'SBP']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0005824', 'cui_str': 'Blood pressure taking'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]",[],"[{'cui': 'C0005824', 'cui_str': 'Blood pressure taking'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",3074.0,0.133004,"SBP was smaller for participants in the standard treatment group (4.6 mm Hg [95% CI, 4.4-4.9 mm Hg]).","[{'ForeName': 'Paul E', 'Initials': 'PE', 'LastName': 'Drawz', 'Affiliation': 'Division of Renal Diseases and Hypertension, University of Minnesota, Minneapolis.'}, {'ForeName': 'Anil', 'Initials': 'A', 'LastName': 'Agarwal', 'Affiliation': 'Division of Nephrology, The Ohio State University Wexner Medical Center, Columbus.'}, {'ForeName': 'Jamie P', 'Initials': 'JP', 'LastName': 'Dwyer', 'Affiliation': 'Division of Nephrology/Hypertension, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Horwitz', 'Affiliation': 'Division of Nephrology and Hypertension, MetroHealth Medical Center, Case Western Reserve University. Cleveland, Ohio.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Lash', 'Affiliation': 'Division of Nephrology, Department of Medicine, University of Illinois, Chicago.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Lenoir', 'Affiliation': 'Department of Biostatistics and Data Science, Division of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'McWilliams', 'Affiliation': 'Department of Internal Medicine, Center for Outcomes Research and Evaluation, Atrium Health, Charlotte, North Carolina.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Oparil', 'Affiliation': 'Division of Cardiovascular Disease, Department of Medicine, University of Alabama at Birmingham.'}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Rahbari-Oskoui', 'Affiliation': 'Division of Renal Medicine, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Mahboob', 'Initials': 'M', 'LastName': 'Rahman', 'Affiliation': 'Division of Nephrology and Hypertension, Department of Medicine, Case Western Reserve University, Cleveland, Ohio.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Parkulo', 'Affiliation': 'Division of Community Internal Medicine and Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Jacksonville, Florida.'}, {'ForeName': 'Priscilla', 'Initials': 'P', 'LastName': 'Pemu', 'Affiliation': 'Department of Medicine, Morehouse School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Dominic S', 'Initials': 'DS', 'LastName': 'Raj', 'Affiliation': 'Division of Kidney Diseases and Hypertension, George Washington University, Washington, DC.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Rocco', 'Affiliation': 'Section on Nephrology, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Sandeep', 'Initials': 'S', 'LastName': 'Soman', 'Affiliation': 'Division of Nephrology and Hypertension, Henry Ford Health System, Detroit, Michigan.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Thomas', 'Affiliation': 'Department of Nephrology and Hypertension, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Delphine S', 'Initials': 'DS', 'LastName': 'Tuot', 'Affiliation': 'Division of Nephrology, University of California, San Francisco.'}, {'ForeName': 'Paul K', 'Initials': 'PK', 'LastName': 'Whelton', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Nicholas M', 'Initials': 'NM', 'LastName': 'Pajewski', 'Affiliation': 'Department of Biostatistics and Data Science, Division of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}]",JAMA internal medicine,['10.1001/jamainternmed.2020.5028']
3221,33039717,Nasal function and cardio-respiratory capacity of adolescent with external nasal dilator.,"BACKGROUND


the external nasal dilator (END) has been employed for the purpose of aiding sporting performance. The objective of this study was to evaluate nasal function and cardio-respiratory capacity in healthy adolescent athletes using the END.
METHODS


double-blind, crossover clinical trial in which adolescents were evaluated while using the experimental and placebo END during physical exercise. Values for peak nasal inspiratory flow (PNIF), nasal resistance (NR) and maximal oxygen uptake (VO 2 max) were obtained in randomized order. Additionally, the rating of perceived exertion (RPE) after the cardio-respiratory test was assessed.
RESULTS


for the 71 adolescents evaluated, the use of the experimental END, compared to the placebo, produced a significant improvement in values of PNIF (177.4 ± 20.9 L/min and 172.8 ± 20.2 L/min) (p = 0.020), NR (0.24 ± 0.16 and 0.27 ± 0.16) (p = 0.007), VO 2 max. (39.5 ± 5.2 mL/kg. min-1 and 37.5 ± 5.2 mL/kg. min-1) (p < 0.001) and RPE (6.0 ± 2.2 and 5.5 ± 2.4) (p < 0.001), respectively.
CONCLUSION


the END reduced NR, increased PNIF and improved VO 2 max. In addition, it improved RPE after the maximal cardio-respiratory test. The use of the END can significantly improve nasal function, increase cardio-respiratory capacity and reduce rating of perceived exertion during a maximal test involving adolescent athletes.",2020,"The use of the END can significantly improve nasal function, increase cardio-respiratory capacity and reduce rating of perceived exertion during a maximal test involving adolescent athletes.","['adolescent with external nasal dilator', 'healthy adolescent athletes', 'adolescent athletes']","['placebo', 'external nasal dilator (END']","['rating of perceived exertion (RPE', 'Nasal function and cardio-respiratory capacity', 'values of PNIF', 'nasal function and cardio-respiratory capacity', 'PNIF and improved VO 2 max', 'nasal function, increase cardio-respiratory capacity and reduce rating of perceived exertion', 'peak nasal inspiratory flow (PNIF), nasal resistance (NR) and maximal oxygen uptake (VO 2 max']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0180437', 'cui_str': 'Nasal dilator'}, {'cui': 'C0686747', 'cui_str': 'Well adolescent'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0180437', 'cui_str': 'Nasal dilator'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0429205', 'cui_str': 'Nasal peak inspiratory flow'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0429208', 'cui_str': 'Nasal resistance'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}]",,0.146487,"The use of the END can significantly improve nasal function, increase cardio-respiratory capacity and reduce rating of perceived exertion during a maximal test involving adolescent athletes.","[{'ForeName': 'Carlos Henrique', 'Initials': 'CH', 'LastName': 'Santos Ferreira', 'Affiliation': 'Federal University of Minas Gerais, Post Graduate Program in Health Sciences, Faculty of Medicine, Department of Pediatrics, Belo Horizonte, MG, Brazil.'}, {'ForeName': 'Ricardo Reis', 'Initials': 'RR', 'LastName': 'Dinardi', 'Affiliation': 'Federal University of Minas Gerais, Post Graduate Program in Health Sciences, Faculty of Medicine, Department of Pediatrics, Belo Horizonte, MG, Brazil; Pontifical Catholic University of Minas Gerais, Department of Physical Education. Belo Horizonte, MG, Brazil. Electronic address: dinardi06@hotmail.com.'}, {'ForeName': 'Cássio', 'Initials': 'C', 'LastName': 'da Cunha Ibiapina', 'Affiliation': 'Federal University of Minas Gerais, Post Graduate Program in Health Sciences, Faculty of Medicine, Department of Pediatrics, Belo Horizonte, MG, Brazil.'}, {'ForeName': 'Cláudia', 'Initials': 'C', 'LastName': 'Ribeiro de Andrade', 'Affiliation': 'Federal University of Minas Gerais, Post Graduate Program in Health Sciences, Faculty of Medicine, Department of Pediatrics, Belo Horizonte, MG, Brazil.'}]",International journal of pediatric otorhinolaryngology,['10.1016/j.ijporl.2020.110430']
3222,33039810,"Effect of urea cream on sorafenib-associated hand-foot skin reaction in patients with hepatocellular carcinoma: A multicenter, randomised, double-blind controlled study.","BACKGROUND


Hand-foot skin reaction (HFSR) is the most common adverse event during sorafenib treatment in patients with hepatocellular carcinoma (HCC). In the present study, we aimed to investigate the role of urea cream in the prevention of HFSR or amelioration of HFSR severity.
PATIENTS AND METHODS


Patients with HCC were treated with either placebo cream or urea cream for 12 weeks concomitantly with sorafenib treatment. HFSR development, the Hand-Foot Skin Reaction and Quality of Life (HF-QoL) questionnaire score, and adverse events were assessed at 2, 4, 8 and 12 weeks.
RESULTS


Of the 288 patients, 247 patients, with 117 patients in the placebo control group and 130 patients in the urea cream group, were analysed. The urea cream group showed a trend towards a lower cumulative incidence of any-grade HFSR (log-rank, P = 0.247) and severe HFSR of grade II or higher (log-rank, P = 0.394) without statistical significance. In the incidence by time point, the incidence of severe HFSR of grade II or higher was significantly lower in the urea cream group than in the placebo control group at 2 weeks (13.8% versus 23.9%, P = 0.042). The urea cream group showed a significantly better HF-QoL questionnaire score than the placebo control group (11.8 versus 19.7, P = 0.014) at 12 weeks.
CONCLUSIONS


Treatment with urea cream showed a lower incidence of severe sorafenib-induced HFSR at 2 weeks and reduced the tendency of HFSR development in HCC patients. Therefore, treatment with urea cream may be considered for prophylaxis or improvement of HFSR grade in HCC patients treated with sorafenib.
TRIAL REGISTRATION


ClinicalTrials.gov (NCT03212625).",2020,"The urea cream group showed a significantly better HF-QoL questionnaire score than the placebo control group (11.8 versus 19.7, P = 0.014) at 12 weeks.
","['Patients with HCC', 'patients with hepatocellular carcinoma', 'patients with hepatocellular carcinoma (HCC', '288 patients, 247 patients, with 117 patients in the placebo control group and 130 patients in the urea cream group']","['Hand-foot skin reaction (HFSR', 'placebo cream or urea cream', 'sorafenib treatment', 'urea cream']","['incidence of severe HFSR of grade II or higher', 'HFSR development, the Hand-Foot Skin Reaction and Quality of Life (HF-QoL) questionnaire score, and adverse events', 'HF-QoL questionnaire score', 'cumulative incidence of any-grade HFSR', 'tendency of HFSR development', 'severe HFSR of grade II', 'sorafenib-associated hand-foot skin reaction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0041942', 'cui_str': 'Urea'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0222289', 'cui_str': 'Skin structure of foot'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0041942', 'cui_str': 'Urea'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0222289', 'cui_str': 'Skin structure of foot'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}]",288.0,0.149479,"The urea cream group showed a significantly better HF-QoL questionnaire score than the placebo control group (11.8 versus 19.7, P = 0.014) at 12 weeks.
","[{'ForeName': 'Young-Sun', 'Initials': 'YS', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Korea University College of Medicine, Seoul, South Korea. Electronic address: lys810@korea.ac.kr.'}, {'ForeName': 'Young K', 'Initials': 'YK', 'LastName': 'Jung', 'Affiliation': 'Department of Internal Medicine, Korea University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Ji H', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Korea University College of Medicine, Seoul, South Korea. Electronic address: kjhhepar@naver.com.'}, {'ForeName': 'Sung B', 'Initials': 'SB', 'LastName': 'Cho', 'Affiliation': 'Department of Internal Medicine, Chonnam National University Medical School, South Korea. Electronic address: portalvein@naver.com.'}, {'ForeName': 'Do Y', 'Initials': 'DY', 'LastName': 'Kim', 'Affiliation': 'Yonsei Liver Center, Severance Hospital, Seoul, South Korea.'}, {'ForeName': 'Moon Y', 'Initials': 'MY', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju Severance Christan Hospital, South Korea.'}, {'ForeName': 'Hyung J', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Chung-Ang University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Yeon S', 'Initials': 'YS', 'LastName': 'Seo', 'Affiliation': 'Department of Internal Medicine, Korea University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Ki T', 'Initials': 'KT', 'LastName': 'Yoon', 'Affiliation': 'Department of Internal Medicine, Pusan National University College of Medicine, Liver center, Pusan National University Yangsan Hospital, Yangsan, South Korea.'}, {'ForeName': 'Young M', 'Initials': 'YM', 'LastName': 'Hong', 'Affiliation': 'Department of Internal Medicine, Pusan National University College of Medicine, Liver center, Pusan National University Yangsan Hospital, Yangsan, South Korea.'}, {'ForeName': 'Jeong-Hoon', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, South Korea.'}, {'ForeName': 'Hyun W', 'Initials': 'HW', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Yonsei University College of Medicine, South Korea.'}, {'ForeName': 'Hyung J', 'Initials': 'HJ', 'LastName': 'Yim', 'Affiliation': 'Department of Internal Medicine, Korea University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Byoung K', 'Initials': 'BK', 'LastName': 'Jang', 'Affiliation': 'Department of Internal Medicine, Keimyung University School of Medicine, South Korea.'}, {'ForeName': 'Eun S', 'Initials': 'ES', 'LastName': 'Jang', 'Affiliation': 'Department of Intetnal Medicine, Seoul National University Bundang Hospital, Seongnam, Gyeonggi, South Korea.'}, {'ForeName': 'Jae Y', 'Initials': 'JY', 'LastName': 'Jang', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Soonchunhyang University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Sang Y', 'Initials': 'SY', 'LastName': 'Hwang', 'Affiliation': 'Department of Internal Medicine, Dongnam Institute of Radiological & Medical Sciences, South Korea.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.09.012']
3223,33039853,Effectiveness of expiratory flow acceleration in patients with Parkinson's disease and swallowing deficiency: A preliminary study.,"OBJECTIVES


Parkinson's disease (PD) causes dysfunction both to swallowing and to the cough mechanism. Oropharyngeal dysphagia is the main cause of pneumonia, due to silent aspiration of food and saliva. Pneumonia is the leading cause of death in PD. Different strategies exist to reduce the risk of inhalation and associated lung infections, but evidence of their efficacy is still unclear. The aim of this preliminary study was to investigate if adding an expiratory flow acceleration (EFA®) technique to standard therapy (ST) for dysphagia can reduce the incidence of bronchopulmonary infections and improve quality of life, respiratory function parameters, cough, and airways encumbrance perception.
MATERIALS AND METHODS


Twenty-five patients with PD were randomized to two groups: ST vs. ST + EFA. Patients were re-assessed at 30, 180 and 360 days from start of treatment. The primary outcome was the incidence of respiratory exacerbations together with quality of life score (PDQ-39). Secondary outcomes were changes in respiratory function tests, cough capacity (CPEF), perceived health status (Euro-QOL-VAS), cough, and upper airways encumbrance perception evaluated by visual numeric scale (VNS).
RESULTS


Twenty patients concluded the study (10 each group). Albeit the difference was not significant, less respiratory infections, symptoms, hospital admissions and medical visits were found in the study group. Furthermore, there was a significant difference in cough effectiveness measured with the peak cough expiratory flow (PCEF) and other spirometry parameters (FEV 1 , FVC), and also in specific and generic health-related quality of life measures (PDQ-39, Euro-QoL-VAS).
CONCLUSION


The results of this preliminary study support the use of EFA® technology in Parkinson's patients with dysphagia to reduce the risk of respiratory complications. Nevertheless, further studies are needed in a larger, more representative sample to definitively confirm the usefulness of this technique in PD patients.",2020,"Albeit the difference was not significant, less respiratory infections, symptoms, hospital admissions and medical visits were found in the study group.","[""Parkinson's patients with dysphagia"", 'Twenty-five patients with PD', 'Twenty patients concluded the study (10 each group', ""patients with Parkinson's disease and swallowing deficiency""]","['expiratory flow acceleration (EFA®) technique to standard therapy (ST', 'EFA® technology', 'expiratory flow acceleration', 'ST vs. ST\u202f+\u202fEFA']","['cough effectiveness', 'changes in respiratory function tests, cough capacity (CPEF), perceived health status (Euro-QOL-VAS), cough, and upper airways encumbrance perception evaluated by visual numeric scale (VNS', 'peak cough expiratory flow (PCEF) and other spirometry parameters (FEV 1 , FVC), and also in specific and generic health-related quality of life measures (PDQ-39, Euro-QoL-VAS', 'respiratory infections, symptoms, hospital admissions and medical visits', 'incidence of respiratory exacerbations together with quality of life score (PDQ-39', 'quality of life, respiratory function parameters, cough, and airways encumbrance perception']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0917903', 'cui_str': 'Conclude Composite Resin'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}]","[{'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0000894', 'cui_str': 'Acceleration'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C1533125', 'cui_str': 'Euro'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0225377', 'cui_str': 'Structure of upper respiratory tract cavity'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C3714541', 'cui_str': 'Forced vital capacity'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0035243', 'cui_str': 'Respiratory tract infection'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C4759659', 'cui_str': 'With quality'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}]",25.0,0.0541415,"Albeit the difference was not significant, less respiratory infections, symptoms, hospital admissions and medical visits were found in the study group.","[{'ForeName': 'Giulio', 'Initials': 'G', 'LastName': 'Riboldazzi', 'Affiliation': ""Parkinson's Disease Unit, Gaetano and Piera Borghi Foundation, Brebbia, Italy.""}, {'ForeName': 'Giada', 'Initials': 'G', 'LastName': 'Spinazza', 'Affiliation': 'Neurology Rehabilitation Department, Hospital of Cuasso al Monte, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Beccarelli', 'Affiliation': 'Pulmonary Rehabilitation Unit, General Hospital, Sestri Levante, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Prato', 'Affiliation': 'Pulmonary Rehabilitation Unit, General Hospital, Sestri Levante, Italy.'}, {'ForeName': 'Bruna', 'Initials': 'B', 'LastName': 'Grecchi', 'Affiliation': 'Physical Medicine and Rehabilitation Department, General Hospital, Sestri Levante, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': ""D'Abrosca"", 'Affiliation': 'Italian Association of Respiratory Physiotherapists (ARIR), Milan, Italy.'}, {'ForeName': 'Antonello', 'Initials': 'A', 'LastName': 'Nicolini', 'Affiliation': 'Pulmonary Rehabilitation Unit, General Hospital, Sestri Levante, Italy. Electronic address: antonellonicolini@gmail.com.'}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2020.106249']
3224,33040011,Is arthropla S ty b E tter than inter N al fixation for undi S placed femoral n E ck fracture? A national pragmatic RCT: the  SENSE  trial.,"INTRODUCTION


Undisplaced femoral neck fractures (FNFs) are usually treated by internal fixation (IF) but two randomised controlled trials (RCTs) have demonstrated advantages of treatment with arthroplasty. The complication rate was lowered but there were no clinically improved patient-reported outcome measures (PROM), which could be due to underpowering or choice of selected PROM as the studies do appear to report a better functional outcome. We will conduct an RCT comparing IF with arthroplasties in patients aged over 65 years with an undisplaced FNF.
METHODS AND ANALYSIS


All hospitals in Denmark treating patients with hip fracture can provide patients for this study; therefore, the study can be considered a national RCT. Patients over 65 years old with an undisplaced FNF will be screened for eligibility and patients will only be excluded if they are unable to understand the study information (due to dementia or language), if they have a posterior tilt >20°, a pathological fracture or they cannot walk. Participants will be electronically randomised (in alternating blocks of 4 or 6) into either IF or arthroplasty. Postoperative care will follow the department standards.Primary and secondary outcomes and measuring points have been established in collaboration with patients with hip fracture by focus group interviews. The primary outcome measure is the New Mobility Score assessed after 1 year. Secondary outcomes are the Oxford Hip Score, EuroQol 5 domain (EQ-5D-5L), degree of posterior tilt, pain Verbal Rating Scale, reoperation and mortality.
ETHICS AND DISSEMINATION


The study is approved by the Danish Data Protection Agency (19/7429) and the scientific ethics committee (S-20180036). All participants will sign an informed consent before entering the trial. Because this is a national trial, all relevant healthcare professionals in Denmark will automatically receive the trial results that will be published in international peer-reviewed journals.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov Registry (NCT04075461).",2020,"The complication rate was lowered but there were no clinically improved patient-reported outcome measures (PROM), which could be due to underpowering or choice of selected PROM as the studies do appear to report a better functional outcome.","['All hospitals in Denmark treating patients with hip fracture', 'patients aged over 65 years with an undisplaced FNF', 'Patients over 65 years old with an']","['IF or arthroplasty', 'undisplaced FNF']","['New Mobility Score assessed after 1\u2009year', 'Oxford Hip Score, EuroQol 5 domain (EQ-5D-5L), degree of posterior tilt, pain Verbal Rating Scale, reoperation and mortality', 'complication rate']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0443336', 'cui_str': 'Undisplaced'}, {'cui': 'C0033228', 'cui_str': 'Fenofibrate'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0016642', 'cui_str': 'Internal fixation of fracture'}, {'cui': 'C0003893', 'cui_str': 'Arthroplasty'}, {'cui': 'C0443336', 'cui_str': 'Undisplaced'}, {'cui': 'C0033228', 'cui_str': 'Fenofibrate'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1998079', 'cui_str': 'Oxford hip score'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0458261', 'cui_str': 'Verbal rating scale'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",,0.3056,"The complication rate was lowered but there were no clinically improved patient-reported outcome measures (PROM), which could be due to underpowering or choice of selected PROM as the studies do appear to report a better functional outcome.","[{'ForeName': 'Bjarke', 'Initials': 'B', 'LastName': 'Viberg', 'Affiliation': 'Orthopaedic Surgery and Traumatology, Lillebaelt Hospital, University Hospital of Southern Denmark, Kolding, Denmark bjarke.viberg@rsyd.dk.'}, {'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Kold', 'Affiliation': 'Orthopaedic Surgery and Traumatology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'Brink', 'Affiliation': 'Orthopaedic Surgery and Traumatology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Morten Schultz', 'Initials': 'MS', 'LastName': 'Larsen', 'Affiliation': 'Orthopaedic Surgery and Traumatology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Kristoffer Borbjerg', 'Initials': 'KB', 'LastName': 'Hare', 'Affiliation': 'Department of Regional Health Research, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Palm', 'Affiliation': 'Orthopaedic Surgery and Traumatology, Bispebjerg Hospital, Kobenhavn, Denmark.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2020-038442']
3225,33040012,"Validation of an integrated service model, Health-RESPECT, for older patients in long-term care institution using information and communication technologies: protocol of a cluster randomised controlled trial.","INTRODUCTION


There is an increased healthcare need to manage institutionalised older patients owing to the ageing population. To overcome substantial future challenges, the Health-RESPECT (caRE Systems for Patients/Elderly with Coordinated care using icT), a new information and communication technologies based integrated management service model, was developed to provide effective management, enable consultation with distant professionals and share medical information between acute care hospitals and long-term care institutions.
METHODS AND ANALYSIS


A cluster randomised controlled trial will be conducted to examine the effectiveness of the Health-RESPECT in older patients with chronic diseases and their medical staff in charge. Intervention involves registration with simple comprehensive geriatric assessment, establishment of an individualised care plan for three chronic diseases (hypertension, diabetes and heart failure), medication and rehabilitation management, periodic video-conference and in-system assessment after intervention period. Primary outcomes are control levels of the three chronic diseases, adequacy of drug management and overall functional status. Patients will be assessed at before and after study period and 3 months after study ended. Analysis will be carried out with an intention-to-treat principle. In addition to evaluate intervention effects, clinical usability and economic evaluation will be assessed.
ETHICS AND DISSEMINATION


The study protocol was reviewed and approved by the Seoul National University Bundang Hospital Institutional Review Board. Study findings will be published in peer-reviewed journals.
TRIAL REGISTRATION NUMBER


KCT0004360.",2020,A cluster randomised controlled trial will be conducted to examine the effectiveness of the Health-RESPECT in older patients with chronic diseases and their medical staff in charge.,"['older patients with chronic diseases and their medical staff in charge', 'Patients/Elderly with Coordinated care using icT', 'older patients in long-term care institution']","['Intervention involves registration with simple comprehensive geriatric assessment, establishment of an individualised care plan']","['control levels of the three chronic diseases, adequacy of drug management and overall functional status']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0025106', 'cui_str': 'Medical Staffs'}, {'cui': 'C0007961', 'cui_str': 'Charges'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0427184', 'cui_str': 'No incoordination'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0017463', 'cui_str': 'Geriatric screening'}, {'cui': 'C0178916', 'cui_str': 'Care plan'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",3.0,0.0862522,A cluster randomised controlled trial will be conducted to examine the effectiveness of the Health-RESPECT in older patients with chronic diseases and their medical staff in charge.,"[{'ForeName': 'Jung-Yeon', 'Initials': 'JY', 'LastName': 'Choi', 'Affiliation': 'Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea (the Republic of).'}, {'ForeName': 'Kwang-Il', 'Initials': 'KI', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea (the Republic of) kikim907@snu.ac.kr.'}, {'ForeName': 'Hongsoo', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Department of Public Health Sciences, Seoul National University Graduate School of Public Health, Gwanak-gu, Korea (the Republic of).'}, {'ForeName': 'Young-Il', 'Initials': 'YI', 'LastName': 'Jung', 'Affiliation': 'Department of Environmental Health, Korea National Open University, Jongno-gu, Korea (the Republic of).'}, {'ForeName': 'In-Hwan', 'Initials': 'IH', 'LastName': 'Oh', 'Affiliation': 'Department of Preventive Medicine, Kyung Hee University, Seoul, Korea (the Republic of).'}, {'ForeName': 'Seungyeon', 'Initials': 'S', 'LastName': 'Chun', 'Affiliation': 'Department of Public Health Sciences, Seoul National University Graduate School of Public Health, Gwanak-gu, Korea (the Republic of).'}, {'ForeName': 'Gi-Soo', 'Initials': 'GS', 'LastName': 'Kim', 'Affiliation': 'Department of Industrial Engineering, Ulsan National Institute of Science and Technology, Ulsan, Korea (the Republic of).'}, {'ForeName': 'Jae-Young', 'Initials': 'JY', 'LastName': 'Lim', 'Affiliation': 'Institute of Aging, Seoul National University, Gwanak-gu, Korea (the Republic of).'}, {'ForeName': 'Jin Young', 'Initials': 'JY', 'LastName': 'Ko', 'Affiliation': 'Department of Rehabilitation Medicine, Seoul National University Bundang Hospital, Seongnam, Korea (the Republic of).'}]",BMJ open,['10.1136/bmjopen-2020-038598']
3226,33033088,"Effectiveness and cost-effectiveness of a progressive, individualised walking and education programme for prevention of low back pain recurrence in adults: study protocol for the WalkBack randomised controlled trial.","INTRODUCTION


Low back pain (LBP) is recognised globally as a prevalent, costly and disabling condition. Recurrences are common and contribute to much of the burden of LBP. Current evidence favours exercise and education for prevention of LBP recurrence, but an optimal intervention has not yet been established. Walking is a simple, widely accessible, low-cost intervention that has yet to be evaluated. This randomised controlled trial (RCT) aims to establish the effectiveness and cost-effectiveness of a progressive and individualised walking and education programme (intervention) for the prevention of LBP recurrences in adults compared with no treatment (control).
METHODS AND ANALYSIS


A pragmatic, two-armed RCT comparing walking and education (n=349) with a no treatment control group (n=349). Inclusion criteria are adults recovered from an episode of non-specific LBP within the last 6 months. Those allocated to the intervention group will receive six sessions (three face to face and three telephone delivered) with a trained physiotherapist to facilitate a progressive walking programme and education over a 6-month period. The primary outcome will be days to first recurrence of an episode of activity-limiting LBP. The secondary outcomes include days to recurrence of an episode of LBP, days to recurrence of an episode of LBP leading to care seeking, disability and quality of life measured at 3, 6, 9 and 12 months and costs associated with LBP recurrence. All participants will be followed up monthly for a minimum of 12 months. The primary intention-to-treat analysis will assess difference in survival curves (days to recurrence) using the log-rank statistic. The cost-effectiveness analysis will be conducted from the societal perspective.
ETHICS AND DISSEMINATION


Approved by Macquarie University Human Research Ethics Committee (Reference: 5201949218164, May 2019). Findings will be disseminated through publication in peer-reviewed journals and conference presentations.
TRIAL REGISTRATION NUMBER


ACTRN12619001134112.",2020,"This randomised controlled trial (RCT) aims to establish the effectiveness and cost-effectiveness of a progressive and individualised walking and education programme (intervention) for the prevention of LBP recurrences in adults compared with no treatment (control).
","['adults compared with no treatment (control', 'low back pain recurrence in adults']","['six sessions (three face to face and three telephone delivered) with a trained physiotherapist to facilitate a progressive walking programme and education', 'RCT comparing walking and education', 'progressive and individualised walking and education programme (intervention', 'progressive, individualised walking and education programme']","['effectiveness and cost-effectiveness', 'LBP recurrences', 'days to recurrence of an episode of LBP, days to recurrence of an episode of LBP leading to care seeking, disability and quality of life', 'LBP recurrence', 'days to first recurrence of an episode of activity-limiting LBP', 'Effectiveness and cost-effectiveness', 'survival curves']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]","[{'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205134', 'cui_str': 'Curved'}]",,0.201652,"This randomised controlled trial (RCT) aims to establish the effectiveness and cost-effectiveness of a progressive and individualised walking and education programme (intervention) for the prevention of LBP recurrences in adults compared with no treatment (control).
","[{'ForeName': 'Natasha Celeste', 'Initials': 'NC', 'LastName': 'Pocovi', 'Affiliation': 'Department of Health Professions, Macquarie University, Sydney, New South Wales, Australia tash.pocovi@mq.edu.au.'}, {'ForeName': 'Chung-Wei C', 'Initials': 'CC', 'LastName': 'Lin', 'Affiliation': 'Institute for Musculoskeletal Health, The University of Sydney and Sydney Local Health District, Sydney, New South Wales, Australia.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Latimer', 'Affiliation': 'Institute for Musculoskeletal Health, The University of Sydney and Sydney Local Health District, Sydney, New South Wales, Australia.'}, {'ForeName': 'Dafna', 'Initials': 'D', 'LastName': 'Merom', 'Affiliation': 'Department of Physical Activity and Health, Western Sydney University, Sydney, New South Wales, Australia.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Tiedemann', 'Affiliation': 'Institute for Musculoskeletal Health, The University of Sydney and Sydney Local Health District, Sydney, New South Wales, Australia.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Maher', 'Affiliation': 'Institute for Musculoskeletal Health, The University of Sydney and Sydney Local Health District, Sydney, New South Wales, Australia.'}, {'ForeName': 'Maurits W', 'Initials': 'MW', 'LastName': 'van Tulder', 'Affiliation': 'Health Sciences, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Macaskill', 'Affiliation': 'Sydney School of Public Health, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Ornella', 'Initials': 'O', 'LastName': 'Clavisi', 'Affiliation': 'Musculoskeletal Australia, Melbourne, Victoria, Australia.'}, {'ForeName': 'Shuk Yin Kate', 'Initials': 'SYK', 'LastName': 'Tong', 'Affiliation': 'Department of Health Professions, Macquarie University, Sydney, New South Wales, Australia.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Hancock', 'Affiliation': 'Department of Health Professions, Macquarie University, Sydney, New South Wales, Australia.'}]",BMJ open,['10.1136/bmjopen-2020-037149']
3227,33033091,Perioperative patient-controlled regional analgesia versus patient-controlled intravenous analgesia for patients with critical limb ischaemia: a study protocol for a randomised controlled trial.,"INTRODUCTION


Both regional analgesia and intravenous analgesia are frequently used perioperatively for patients with critical limb ischaemia (CLI). Nevertheless, the comparison of perioperative effect of regional and intravenous analgesia has not yet been thoroughly illustrated. This study will comprehensively compare patient-controlled regional analgesia (PCRA) and patient-controlled intravenous analgesia (PCIA) as two different perioperative analgesia approaches for patients with CLI. It investigates their effects on analgesia, reperfusion and the quality of recovery perioperatively, also aims to provide clinical evidence to those non-surgical patients with non-reconstructable arteries.
METHODS AND ANALYSIS


This trial is a randomised, single-centre, open-label, parallel trial with target sample size of 52 in total. Eligible participants will be randomly allocated to the PCRA group (group R) or the PCIA group (group I) after admission. Participants in group R will receive ultrasound-guided subgluteal sciatic catheterisation, followed by continuous PCRA infusion (0.2% ropivacaine 15 mL as loading dose, 8 mL/hour as background with a patient-controlled bolus of 6 mL). Participants in group I will receive PCIA (morphine is given in boluses of 1 mg as needed, background infusion at 1 mg/hour). Data will be collected at baseline (T0), 2 hours before revascularisation treatment (T1) and 2 hours before discharge (T2). The primary outcomes include the Numerical Rating Scale pain score at T1 and T2. The secondary outcomes include the perioperative transcutaneous oxygen pressure, the Tissue Haemoglobin Index, Hospital Anxiety and Depression Scale at T1 and T2; the Patient Global Impression of Change and patient satisfaction at T1 and T2; the perioperative cumulative morphine consumption, the length of postoperative hospital stay and adverse events.
ETHICS AND DISSEMINATION


This study received authorisation from the Institutional Review Board of Peking Union Medical College Hospital on 21 March 2017 (approval no. ZS-1289X). Study findings will be disseminated through presentations at scientific conferences or publications in peer-reviewed journals.
TRIAL REGISTRATION NUMBER


Chinese Clinical Trial Registry (ChiCTR2000029298).
PROTOCOL VERSION


V.4CP.B2 (15 June 2020).",2020,"The secondary outcomes include the perioperative transcutaneous oxygen pressure, the Tissue Haemoglobin Index, Hospital Anxiety and Depression Scale at T1 and T2; the Patient Global Impression of Change and patient satisfaction at T1 and T2; the perioperative cumulative morphine consumption, the length of postoperative hospital stay and adverse events.
","['patients with critical limb ischaemia', 'patients with CLI', 'Peking Union Medical College Hospital on 21 March 2017 (approval no. ZS-1289X', 'V.4CP.B2 (15 June 2020', 'surgical patients with non-reconstructable arteries', 'patients with critical limb ischaemia (CLI', 'Eligible participants']","['PCRA', 'ultrasound-guided subgluteal sciatic catheterisation, followed by continuous PCRA infusion (0.2% ropivacaine', 'Perioperative patient-controlled regional analgesia versus patient-controlled intravenous analgesia', 'patient-controlled regional analgesia (PCRA) and patient-controlled intravenous analgesia (PCIA', 'PCIA (morphine', 'PCIA']","['perioperative transcutaneous oxygen pressure, the Tissue Haemoglobin Index, Hospital Anxiety and Depression Scale at T1 and T2; the Patient Global Impression of Change and patient satisfaction at T1 and T2; the perioperative cumulative morphine consumption, the length of postoperative hospital stay and adverse events', 'Numerical Rating Scale pain score at T1 and T2']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1142264', 'cui_str': 'Critical limb ischemia'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]","[{'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",,0.17805,"The secondary outcomes include the perioperative transcutaneous oxygen pressure, the Tissue Haemoglobin Index, Hospital Anxiety and Depression Scale at T1 and T2; the Patient Global Impression of Change and patient satisfaction at T1 and T2; the perioperative cumulative morphine consumption, the length of postoperative hospital stay and adverse events.
","[{'ForeName': 'Si', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Zhonghuang', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'Department of Anesthesiology, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Hongju', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Yuelun', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Medical Research Center, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Jiao', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Yuexin', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Vascular Surgery, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Yuehong', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': 'Department of Vascular Surgery, Peking Union Medical College Hospital, Beijing, China yuehongzheng@yahoo.com.'}, {'ForeName': 'Yuguang', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Department of Anesthesiology, Peking Union Medical College Hospital, Beijing, China.'}]",BMJ open,['10.1136/bmjopen-2020-037879']
3228,33034421,"An open-label, randomized crossover study to evaluate the acceptability and preference for contraceptive options in female adolescents, 15 to 19 years of age in Cape Town, as a proxy for HIV prevention methods (UChoose).","INTRODUCTION


Young women in Southern Africa have extremely high HIV incidence rates necessitating the availability of female-controlled prevention methods. Understanding adolescent preference for seeking contraception would improve our understanding of acceptability, feasibility and adherence to similar modes of delivery for HIV prevention.
METHODS


UChoose was an open-label randomized crossover study over 32 weeks which aimed to evaluate the acceptability and preference for contraceptive options in healthy, HIV-uninfected, female adolescents aged 15 to 19 years, as a proxy for similar HIV prevention methods. Participants were assigned to a contraceptive method for a period of 16 weeks in the form of a bi-monthly injectable contraceptive, monthly vaginal Nuvaring ®  or daily combined oral contraceptive (COC) and then asked to state their preference. At 16 weeks, participants crossed over to another contraceptive method, to ensure that all participants tried the Nuvaring ®  (least familiar modality) and additionally, either the injection or COC. Primary outcomes were contraceptive acceptability and preference. At the end of the 32 weeks they were also asked to imagine their preference for an HIV prevention modality. Secondary endpoints included changes in sexual behaviour, contraceptive adherence and preference for biomedical and behavioural HIV prevention methods.
RESULTS


Of the 180 participants screened, 130 were enrolled and randomized to the Nuvaring ®  (n = 45), injection (n = 45) or COC (n = 40). Significantly more Nuvaring ®  users (24/116; 20.7%) requested to change to another contraceptive option compared to injection (1/73; 1.4% p = 0.0002) and COC users (4/49; 8% p = 0.074). Of those that remained on the Nuvaring ®  , adherence was significantly higher than to COC (p < 0.0001). Significantly more injection users (77/80; 96.3%) thought this delivery mode was convenient to use compared to Nuvaring ®  (74/89; 83.1%; p = 0.0409) or COC (38/50; 76.0%; p = 0.0034). Overall, the preferred contraceptive choice was injection, followed by the ring and lastly the pill.
CONCLUSIONS


Adherence to daily COC was difficult for adolescents in this cohort and the least favoured potential HIV prevention option. While some preferred vaginal ring use, these data suggest that long-acting injectables would be the preferred prevention method for adolescent girls and young women. This study highlights the need for additional options for HIV prevention in youth.",2020,Significantly more injection users (77/80; 96.3%) thought this delivery mode was convenient to use compared to Nuvaring ®  (74/89; 83.1%; p = 0.0409) or COC (38/50; 76.0%; p = 0.0034).,"['Young women in Southern Africa', 'HIV prevention in youth', 'female adolescents, 15 to 19 years of age in Cape Town, as a proxy for HIV prevention methods (UChoose', '180 participants screened, 130 were enrolled and randomized to the Nuvaring ®  (n\xa0=\xa045), injection (n\xa0=\xa045) or', 'healthy, HIV-uninfected, female adolescents aged 15 to 19\xa0years, as a proxy for similar HIV prevention methods', 'adolescent girls and young women']","['COC', 'bi-monthly injectable contraceptive, monthly vaginal Nuvaring ®  or daily combined oral contraceptive (COC']","['acceptability and preference', 'changes in sexual behaviour, contraceptive adherence and preference for biomedical and behavioural HIV prevention methods', 'contraceptive acceptability and preference']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001746', 'cui_str': 'Southern Africa'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0054434', 'cui_str': 'caffeic acid phenethyl ester'}, {'cui': 'C0557750', 'cui_str': 'Town environment'}, {'cui': 'C0600420', 'cui_str': 'Proxy'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C1744678', 'cui_str': 'NuvaRing'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C1744678', 'cui_str': 'NuvaRing'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009906', 'cui_str': 'Oral Contraceptives, Combined'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0025663', 'cui_str': 'Method'}]",130.0,0.0785338,Significantly more injection users (77/80; 96.3%) thought this delivery mode was convenient to use compared to Nuvaring ®  (74/89; 83.1%; p = 0.0409) or COC (38/50; 76.0%; p = 0.0034).,"[{'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Gill', 'Affiliation': 'Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Anna-Ursula', 'Initials': 'AU', 'LastName': 'Happel', 'Affiliation': 'Institute of Infectious Diseases and Molecular Medicine, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Pidwell', 'Affiliation': 'Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Mendelsohn', 'Affiliation': 'Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Menna', 'Initials': 'M', 'LastName': 'Duyver', 'Affiliation': 'Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Leigh', 'Initials': 'L', 'LastName': 'Johnson', 'Affiliation': 'Centre for Infectious Diseases Epidemiology and Research, School of Public Health and Family Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Landon', 'Initials': 'L', 'LastName': 'Meyer', 'Affiliation': 'Centre for Infectious Diseases Epidemiology and Research, School of Public Health and Family Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Slack', 'Affiliation': 'HIV AIDS Vaccines Ethics Group, University of KwaZulu-Natal, Durban, South Africa.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Strode', 'Affiliation': 'HIV AIDS Vaccines Ethics Group, University of KwaZulu-Natal, Durban, South Africa.'}, {'ForeName': 'Eve', 'Initials': 'E', 'LastName': 'Mendel', 'Affiliation': 'Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Fynn', 'Affiliation': 'Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Wallace', 'Affiliation': 'Cancer Association of South Africa, Johannesburg, South Africa.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Spiegel', 'Affiliation': 'Department of Health and Human Services, Kelly Government Solutions, Contractor to National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD, USA.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Jaspan', 'Affiliation': 'Institute of Infectious Diseases and Molecular Medicine, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Jo-Ann', 'Initials': 'JA', 'LastName': 'Passmore', 'Affiliation': 'Institute of Infectious Diseases and Molecular Medicine, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Sybil', 'Initials': 'S', 'LastName': 'Hosek', 'Affiliation': 'Stroger Hospital of Cook County, Chicago, IL, USA.'}, {'ForeName': 'Dionne', 'Initials': 'D', 'LastName': 'Smit', 'Affiliation': 'MSD (Pty) Ltd, Halfway House, South Africa.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Rinehart', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC, USA.'}, {'ForeName': 'Linda-Gail', 'Initials': 'LG', 'LastName': 'Bekker', 'Affiliation': 'Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.'}]",Journal of the International AIDS Society,['10.1002/jia2.25626']
3229,33031298,"SUZYTM forceps facilitate nasogastric tube insertion under McGRATHTM MAC videolaryngoscopic guidance: A randomized, controlled trial.","BACKGROUND


Nasogastric tubes can be easily inserted in patients under general anesthesia. However, for difficult cases, insertion techniques that can be used in routine clinical practice are limited. SUZY forceps are designed for the removal of pharyngolaryngeal foreign bodies under guidance of a McGrath videolaryngoscope. We hypothesized that using SUZY forceps under McGrath videolaryngoscopic guidance may facilitate nasogastric tube insertion and tested this in a randomized controlled trial.
METHODS


Adult patients who underwent gastrointestinal or hepato-pancreato-biliary surgery were randomly allocated to 2 groups; the SUZY group and the Magill group. Patients, nurses, and all clinical staff except for the attending anesthesiologist were blinded to group assignment throughout the study. After anesthesia induction, insertion of the nasogastric tube was performed by skilled anesthesiologists with either SUZY or Magill forceps according to group allocation under McGrath videolaryngoscopic guidance. The primary endpoint was insertion time which was defined as the time required to advance the nasogastric tube by 55 cm from the nostril. Secondary endpoints were the success rates of the nasogastric tube insertion, which were defined as a 55-cm advancement from the nostril at the 1st, 2nd, and 3rd attempt, proper insertion rate, the severity of pharyngolaryngeal complications, and hemodynamic parameters during nasogastric tube insertion.
RESULTS


Sixty patients were randomized and none of these patients were excluded from the final analysis. The median [interquartile range] insertion time was 25 [18-33] seconds in the SUZY group, and 33 [21-54] seconds in the Magill group (P = .02). Success rates were not different between the groups (97% and 80% in the SUZY and Magill group at 1st attempt, respectively, P = .10). Both, the severity score of the mucosal injury and the severity of sore throat were higher in the Magill than in the SUZY group, whereas the degree of hoarseness did not differ between the 2 groups. Hemodynamic parameters were not significantly different between the groups.
CONCLUSION


Using SUZY forceps under McGrath videolaryngoscopic guidance reduced the time required to insert a nasogastric tube and the severity of pharyngolaryngeal complications, when compared to using Magill forceps.",2020,"Success rates were not different between the groups (97% and 80% in the SUZY and Magill group at 1st attempt, respectively, P = .10).","['Sixty patients', 'Adult patients who underwent gastrointestinal or hepato-pancreato-biliary surgery', 'patients under general anesthesia']","['SUZY or Magill forceps according to group allocation under McGrath videolaryngoscopic guidance', 'SUZY group and the Magill group']","['Success rates', 'time required to insert a nasogastric tube and the severity of pharyngolaryngeal complications', 'severity score of the mucosal injury and the severity of sore throat', 'Hemodynamic parameters', 'median [interquartile range] insertion time', 'degree of hoarseness', 'success rates of the nasogastric tube insertion, which were defined as a 55-cm advancement from the nostril at the 1st, 2nd, and 3rd attempt, proper insertion rate, the severity of pharyngolaryngeal complications, and hemodynamic parameters', 'insertion time which was defined as the time required to advance the nasogastric tube']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C1828004', 'cui_str': 'Magill forceps, device'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0085678', 'cui_str': 'Nasogastric tube'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0031350', 'cui_str': 'Pharyngitis'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019825', 'cui_str': 'Hoarse'}, {'cui': 'C0204819', 'cui_str': 'Insertion of nasogastric tube'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0441478', 'cui_str': 'Surgical advancement - action'}, {'cui': 'C0595944', 'cui_str': 'Both anterior nares'}, {'cui': 'C0205435', 'cui_str': 'First'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0205437', 'cui_str': 'Third'}]",60.0,0.0965615,"Success rates were not different between the groups (97% and 80% in the SUZY and Magill group at 1st attempt, respectively, P = .10).","[{'ForeName': 'Kenta', 'Initials': 'K', 'LastName': 'Furutani', 'Affiliation': 'Department of Anesthesiology, Niigata University Medical and Dental Hospital.'}, {'ForeName': 'Tatsunori', 'Initials': 'T', 'LastName': 'Watanabe', 'Affiliation': 'Department of Anesthesiology, Uonuma Institute of Community Medicine, Niigata University Medical and Dental Hospital, Minami-Uonuma, Niigata, Japan.'}, {'ForeName': 'Keiichiro', 'Initials': 'K', 'LastName': 'Matsuda', 'Affiliation': 'Department of Anesthesiology, Niigata University Medical and Dental Hospital.'}, {'ForeName': 'Yoshinori', 'Initials': 'Y', 'LastName': 'Kamiya', 'Affiliation': 'Department of Anesthesiology, Niigata University Medical and Dental Hospital.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Baba', 'Affiliation': 'Department of Anesthesiology, Niigata University Medical and Dental Hospital.'}]",Medicine,['10.1097/MD.0000000000022545']
3230,33031329,Effects of dapagliflozin on cardiovascular outcomes in type 2 diabetes: Study protocol of a randomized controlled trial.,"BACKGROUND


Dapagliflozin, a novel inhibitor of renal sodium-glucose cotransporter 2, allows an insulin-independent approach to improve type 2 diabetes hyperglycemia. This current research is a double blinded, randomized, and prospective trial to determine the effect of dapagliflozin on cardiovascular outcomes in type 2 diabetes.
METHODS


This randomized controlled, double-blinded, single center trial is carried out according to the principles of Declaration of Helsinki. This present study was approved in institutional review committee of the Lianyungang Hospital affiliated to Xuzhou Medical University (LW-20200901001). All the patients received the informed consent. Diabetic patients were randomized equally to receive 28-week treatment with dapagliflozin or matching placebo. The major outcome of our current study was the change in the level of hemoglobin A1c (HbA1c) from the baseline to week 28. Secondary outcome measures contained the levels of fasting blood glucose, the mean change in seated systolic and diastolic blood pressure, body weight, and the mean change in calculated average daily insulin dose in patients treated with insulin at baseline, the other laboratory variables, and self-reported adverse events. The P < .05 was regarded as statistically significant.
RESULTS


We assumed that the dapagliflozin administration in patients with type 2 diabetes would reduce HbA1c, body weight, systolic blood pressure, and achieve the goal of glycemic control, without adversely impacting cardiovascular risk.
TRIAL REGISTRATION


This study protocol was registered in Research Registry (researchregistry5987).",2020,"BACKGROUND


Dapagliflozin, a novel inhibitor of renal sodium-glucose cotransporter 2, allows an insulin-independent approach to improve type 2 diabetes hyperglycemia.","['type 2 diabetes', 'patients with type 2 diabetes', 'Diabetic patients', 'Lianyungang Hospital affiliated to Xuzhou Medical University (LW-20200901001']","['dapagliflozin or matching placebo', 'dapagliflozin']","['cardiovascular outcomes', 'laboratory variables, and self-reported adverse events', 'levels of fasting blood glucose, the mean change in seated systolic and diastolic blood pressure, body weight, and the mean change in calculated average daily insulin dose', 'HbA1c, body weight, systolic blood pressure', 'level of hemoglobin A1c (HbA1c']","[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0277814', 'cui_str': 'Sitting position'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}]",,0.258031,"BACKGROUND


Dapagliflozin, a novel inhibitor of renal sodium-glucose cotransporter 2, allows an insulin-independent approach to improve type 2 diabetes hyperglycemia.","[{'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Yin', 'Affiliation': 'Department of endocrinology, Lianyungang Hospital affiliated to Xuzhou Medical University, Jiangsu, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Hui', 'Affiliation': ''}, {'ForeName': 'Chuanhui', 'Initials': 'C', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000022660']
3231,33031335,Impacts of cognitive behavior therapy on occupational stress among science and social science education facilitators in open and distance learning centers and its implications for community development: A randomized trial group.,"BACKGROUND


Extensive review of literature showed that no available study in Nigeria has explored the impact of cognitive behavior therapy (CBT) on the management of occupational stress among open and distance learning (ODL) centers science and social science education facilitators. Thus, this study determined the impacts of CBT on the management of occupational stress among science and social science education facilitators in ODL centers in South-South Nigeria.
METHODS


A randomized controlled trial experimental design was adopted for the study with a sample size of 68 science and social science education facilitators in ODL centers in South-South states, Nigeria. Perceived stress scale (PSS) and Occupational stress index (OSI) were used for data collection. Using Cronbach alpha method, internal consistency reliability indices of 0.81 and 0.85 for PSS and OSI respectively were obtained in the Nigerian context. A 12-week cognitive behavior therapy intervention was conducted after which the participants in both the intervention group and the non-intervention group were administered posttest, while a follow-up assessment was administered after 2 months. Data collected were analyzed using mixed-design repeated-measures analysis of variance for the within-groups and between-groups effects.
RESULTS


It was found that CBT intervention led to a significant decrease in the occupational stress among science and social science education facilitators in ODL in the South-South region of Nigeria.
CONCLUSION


Cognitive behavior therapy is effective in the management of occupational stress among science and social science education facilitators in distance learning centers.",2020,"It was found that CBT intervention led to a significant decrease in the occupational stress among science and social science education facilitators in ODL in the South-South region of Nigeria.
","['study with a sample size of 68 science and social science education facilitators in ODL centers in South-South states, Nigeria', 'ODL centers in South-South Nigeria']","['CBT', 'cognitive behavior therapy intervention', 'cognitive behavior therapy (CBT', 'Cognitive behavior therapy', 'CBT intervention', 'cognitive behavior therapy']","['Perceived stress scale (PSS) and Occupational stress index (OSI', 'occupational stress']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0037434', 'cui_str': 'Social Sciences'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0600563', 'cui_str': 'Distance Learning'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0028075', 'cui_str': 'Nigeria'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0582653', 'cui_str': 'Perceived stress scale'}, {'cui': 'C0814090', 'cui_str': 'Job-related Stress'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",68.0,0.0278059,"It was found that CBT intervention led to a significant decrease in the occupational stress among science and social science education facilitators in ODL in the South-South region of Nigeria.
","[{'ForeName': 'Christian S', 'Initials': 'CS', 'LastName': 'Ugwuanyi', 'Affiliation': 'School of Education Studies, Faculty of Education, University of the Free State, Bloemfontein, South Africa.'}, {'ForeName': 'Chinedu I O', 'Initials': 'CIO', 'LastName': 'Okeke', 'Affiliation': 'School of Education Studies, Faculty of Education, University of the Free State, Bloemfontein, South Africa.'}, {'ForeName': 'Matthias U', 'Initials': 'MU', 'LastName': 'Agboeze', 'Affiliation': 'Department of Adult Education and Extra-Mural Studies, Faculty of Education.'}, {'ForeName': 'Ngozi Justina', 'Initials': 'NJ', 'LastName': 'Igwe', 'Affiliation': 'Department of Adult Education and Extra-Mural Studies, Faculty of Education.'}, {'ForeName': 'Ngozi M', 'Initials': 'NM', 'LastName': 'Eya', 'Affiliation': 'Department of Science Education, Faculty of Education, University of Nigeria, Nsukka, Nigeria.'}, {'ForeName': 'Jovita C', 'Initials': 'JC', 'LastName': 'Ejimonye', 'Affiliation': 'Department of Social Science Education, Faculty of Education.'}, {'ForeName': 'Basil C', 'Initials': 'BC', 'LastName': 'Oguguo', 'Affiliation': 'Department of Science Education, Faculty of Education, University of Nigeria, Nsukka, Nigeria.'}, {'ForeName': 'Catherine U', 'Initials': 'CU', 'LastName': 'Ene', 'Affiliation': 'Department of Science Education, Faculty of Education, University of Nigeria, Nsukka, Nigeria.'}, {'ForeName': 'Chinyere L', 'Initials': 'CL', 'LastName': 'Chukwu', 'Affiliation': 'Department of Social Science Education, Faculty of Education.'}, {'ForeName': 'Elizabeth E', 'Initials': 'EE', 'LastName': 'Obiozor', 'Affiliation': 'Department of Adult Education and Extra-Mural Studies, Faculty of Education.'}, {'ForeName': 'Maryrose N', 'Initials': 'MN', 'LastName': 'Agboeze', 'Affiliation': 'Department of Adult Education and Extra-Mural Studies, Faculty of Education.'}, {'ForeName': 'Ruphina U', 'Initials': 'RU', 'LastName': 'Nwachukwu', 'Affiliation': 'Department of Adult Education and Extra-Mural Studies, Faculty of Education.'}, {'ForeName': 'Uzoamaka L', 'Initials': 'UL', 'LastName': 'Koledoye', 'Affiliation': 'Department of Adult Education and Extra-Mural Studies, Faculty of Education.'}, {'ForeName': 'Queendaline O', 'Initials': 'QO', 'LastName': 'Ibenegbu', 'Affiliation': 'Department of Science Education, Faculty of Education, University of Nigeria, Nsukka, Nigeria.'}, {'ForeName': 'Francis E', 'Initials': 'FE', 'LastName': 'Ikeh', 'Affiliation': 'Department of Science Education, Faculty of Education, University of Nigeria, Nsukka, Nigeria.'}, {'ForeName': 'Monday', 'Initials': 'M', 'LastName': 'Sampson', 'Affiliation': 'Department of Social Science Education, Faculty of Education.'}, {'ForeName': 'Florence O', 'Initials': 'FO', 'LastName': 'Attah', 'Affiliation': 'Department of Science Education, Faculty of Education, University of Nigeria, Nsukka, Nigeria.'}, {'ForeName': 'Chiamaka K', 'Initials': 'CK', 'LastName': 'Ugwuanyi', 'Affiliation': 'Department of Social Science Education, Faculty of Education.'}]",Medicine,['10.1097/MD.0000000000022677']
3232,33031340,The efficacy of bilateral intervertebral foramen block for pain management in percutaneous endoscopic lumbar discectomy: A protocol for randomized controlled trial.,"BACKGROUND


Compared with open lumbar microdiscectomy, percutaneous endoscopic lumbar discectomy (PELD) has the advantages of remarkable preservation of paravertebral structures, less bleeding, shorter operation time and fewer complications, it is a common method for the treatment of lumbar disc herniation (LDH). Local anesthesia is recommended during PELD. However, intraoperative pain is sometimes difficult to control satisfactorily. The efficacy of bilateral intervertebral foramen block (IFB) for pain management in PELD remains unclear. Therefore, this regimen is utilized in a randomized controlled trial for the assessment the safety and effectiveness of bilateral IFB for PELD pain control.
METHOD


This is a single center and randomized controlled trial which will be implemented from September 2020 to September 2021. This research protocol is in accordance with the items of the Standard Protocol for Randomized Trials, which was authorized through the Ethics Committee of Huzhou Central Hospital & Affiliated Centre Hospital of Huzhou University (HZCH0465-0864). 100 participants who undergo PELD will be analyzed. Inclusion criteria containsThe exclusion criteria contains:Patients will be randomly divided into bilateral IFB group (with 50 patients) and local infiltration analgesia group (with 50 patients). Primary outcomes are pain score at different time points. The secondary outcomes are the operative time, radiation exposure time, length of hospital stay and postoperative complications. All the analysis is implemented through applying the IBM SPSS Statistics for Windows, version 20 (IBM Corp., Armonk, NY, USA).
RESULTS


The clinical outcome variables between groups are illustrated in the Table 1.
CONCLUSION


This investigation can offer a reliable basis for the effectiveness and safety of IFB in treating the PELD pain.
TRIAL REGISTRATION


This study protocol is registered in Research Registry (researchregistry5985).",2020,"All the analysis is implemented through applying the IBM SPSS Statistics for Windows, version 20 (IBM Corp., Armonk, NY, USA).
","['September 2020 to September 2021', '100 participants who undergo PELD will be analyzed', 'percutaneous endoscopic lumbar discectomy']","['IFB', 'bilateral intervertebral foramen block', 'local infiltration analgesia', 'bilateral IFB', 'percutaneous endoscopic lumbar discectomy (PELD', 'bilateral intervertebral foramen block (IFB']","['pain score', 'operative time, radiation exposure time, length of hospital stay and postoperative complications']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0408632', 'cui_str': 'Excision of lumbar intervertebral disc'}]","[{'cui': 'C0223085', 'cui_str': 'Structure of intervertebral foramen'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0408632', 'cui_str': 'Excision of lumbar intervertebral disc'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0015333', 'cui_str': 'Exposure to radiation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}]",100.0,0.179244,"All the analysis is implemented through applying the IBM SPSS Statistics for Windows, version 20 (IBM Corp., Armonk, NY, USA).
","[{'ForeName': 'Xiaolan', 'Initials': 'X', 'LastName': 'Sang', 'Affiliation': 'Department of operating room, Huzhou Central Hospital & Affiliated Central Hospital of Huzhou University.'}, {'ForeName': 'Hanmin', 'Initials': 'H', 'LastName': 'Shan', 'Affiliation': 'Department of Anesthesiology.'}, {'ForeName': 'Jiajun', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': 'Department of Anesthesiology.'}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Wu', 'Affiliation': 'Department of Orthopedics and Trauma, Huzhou Central Hospital & Affiliated Centre Hospital of Huzhou Unversity, Zhejiang Province, China.'}]",Medicine,['10.1097/MD.0000000000022693']
3233,33036662,Effects of Ginger on clinical manifestations and paraclinical features of patients with Severe Acute Respiratory Syndrome due to COVID-19: A structured summary of a study protocol for a randomized controlled trial.,"OBJECTIVES


We investigate the effects of Ginger, compared to the usual therapeutic regimen on clinical manifestations and paraclinical features in patients with confirmed COVID-19 that are moderately ill.
TRIAL DESIGN


This is a single center, randomized, double-blind, placebo-controlled clinical trial with parallel group design.
PARTICIPANTS


Inclusion criteria: 1. Patients admitted to Severe Acute Respiratory Syndrome (SARS) Departments at Shahid Mohammadi Hospital, Bandar Abbas, Iran 2. Age ≥18 years (weight ≥35 kg) 3. Hospitalized ≤48 hours 4. Confirmed SARS-CoV-2 diagnosis (Positive polymerase chain reaction (PCR)) 5. Moderate pneumonia and lung involvement in imaging 6. Signing informed consent and willingness of study participant to accept randomization to any assigned treatment arm Exclusion criteria: 1. Underlying diseases, including heart disease, chronic hypertension, severe renal failure, severe liver failure, and thyroid disorders 2. Use of warfarin, selective serotonin reuptake inhibitors (SSRIs), monoamine oxidase inhibitors (MAOIs), diuretics, corticosteroids, and antiarrhythmic drugs 3. Severe and critical pneumonia 4. History of known allergy to Ginger 5. Pregnancy and breastfeeding INTERVENTION AND COMPARATOR: Intervention group: The standard treatment regimen for COVID-19 along with Ginger-based herbal tablets (Vomigone ®, Dineh Pharmaceutical Company, Iran) at a dose of 1000 mg three times a day for a period of seven days.
CONTROL GROUP


The standard treatment for COVID-19 based on the Iranian Ministry of Health and Medical Education's protocol, along with Vomigone-like placebo tablets (Dineh Pharmaceutical Company, Iran) at a dose of two tablets three times a day for a period of seven days.
MAIN OUTCOMES


The primary outcome is recovery rate of clinical symptoms, including fever, dry cough, tiredness, and GI symptoms as well as paraclinical features, including thrombocytopenia, lymphocytopenia, and C-reactive protein within seven days of randomization. Time to improvement of clinical and paraclinical features along with the incidence of serious adverse events are the secondary outcomes within seven days of randomization.
RANDOMIZATION


An interactive web-based system will be used to allocate eligible participants, based on the inclusion and exclusion criteria, to one of the two study arms (in a 1:1 ratio) using block randomization.
BLINDING (MASKING)


All study participants, research coordinators, clinicians, nurses, and investigators will be blinded to the group assignment.
NUMBERS TO BE RANDOMIZED (SAMPLE SIZE)


A total of 84 participants will be randomized into two groups of 42 patients.
TRIAL STATUS


The protocol is Version 1.0, May 23, 2020. Recruitment began July 21, 2020, and is anticipated to be completed by October 30, 2020.
TRIAL REGISTRATION


This clinical trial has been registered in the Iranian Registry of Clinical Trials (IRCT). The registration number is "" IRCT20200506047323N1 "". Registration date is 23 May 2020.
FULL PROTOCOL


The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,"The primary outcome is recovery rate of clinical symptoms, including fever, dry cough, tiredness, and GI symptoms as well as paraclinical features, including thrombocytopenia, lymphocytopenia, and C-reactive protein within seven days of randomization.","['patients with Severe Acute Respiratory Syndrome due to COVID-19', 'patients with confirmed COVID-19 that are moderately ill', '84 participants will be randomized into two groups of 42 patients', 'Patients admitted to Severe Acute Respiratory Syndrome (SARS) Departments at Shahid Mohammadi Hospital, Bandar Abbas, Iran 2', 'Age ≥18 years (weight ≥35 kg']","['Ginger', 'standard treatment regimen for COVID-19 along with Ginger-based herbal tablets (Vomigone ®, Dineh Pharmaceutical Company, Iran', 'placebo', 'warfarin, selective serotonin reuptake inhibitors (SSRIs), monoamine oxidase inhibitors (MAOIs), diuretics, corticosteroids', 'GROUP']","['recovery rate of clinical symptoms, including fever, dry cough, tiredness, and GI symptoms as well as paraclinical features, including thrombocytopenia, lymphocytopenia, and C-reactive protein', 'heart disease, chronic hypertension, severe renal failure, severe liver failure', 'Moderate pneumonia and lung involvement']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1175175', 'cui_str': 'Severe acute respiratory syndrome'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]","[{'cui': 'C0162751', 'cui_str': 'Ginger'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0376667', 'cui_str': 'Herbals'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0013058', 'cui_str': 'Pharmaceutical dose form'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0360105', 'cui_str': 'Selective serotonin re-uptake inhibitor'}, {'cui': 'C0026457', 'cui_str': 'Monoamine oxidase inhibitor'}, {'cui': 'C0012798', 'cui_str': 'Diuretic'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0850149', 'cui_str': 'Dry cough'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0024312', 'cui_str': 'Lymphocytopenia'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0018799', 'cui_str': 'Heart disease'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C0085605', 'cui_str': 'Hepatic failure'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}]",84.0,0.405155,"The primary outcome is recovery rate of clinical symptoms, including fever, dry cough, tiredness, and GI symptoms as well as paraclinical features, including thrombocytopenia, lymphocytopenia, and C-reactive protein within seven days of randomization.","[{'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Safa', 'Affiliation': 'Department of Clinical Pharmacy, Faculty of Pharmacy, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Hassaniazad', 'Affiliation': 'Infectious and Tropical Diseases Research Center, Hormozgan Health Institute, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Farashahinejad', 'Affiliation': 'Infectious and Tropical Diseases Research Center, Hormozgan Health Institute, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Parivash', 'Initials': 'P', 'LastName': 'Davoodian', 'Affiliation': 'Infectious and Tropical Diseases Research Center, Hormozgan Health Institute, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Habib', 'Initials': 'H', 'LastName': 'Dadvand', 'Affiliation': 'Infectious and Tropical Diseases Research Center, Hormozgan Health Institute, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Soheil', 'Initials': 'S', 'LastName': 'Hassanipour', 'Affiliation': 'Gastrointestinal and Liver Diseases Research Center, Guilan University of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Fathalipour', 'Affiliation': 'Department of Pharmacology and Toxicology, Faculty of Pharmacy, Hormozgan University of Medical Sciences, Bandar Abbas, Iran. M.fathalipour@hums.ac.ir.'}]",Trials,['10.1186/s13063-020-04765-6']
3234,33037036,Further improvement in glycemic control after switching from exenatide two times per day to exenatide once-weekly autoinjected suspension in patients with type 2 diabetes: 52-week results from the DURATION-NEO-1 study.,"INTRODUCTION


Investigate the effects of switching from two times per day exenatide to once-weekly exenatide administered by autoinjector (exenatide once-weekly suspension by autoinjector (QWS-AI)) or treatment with exenatide QWS-AI for 1 year.
RESEARCH DESIGN AND METHODS


In this phase III open-label study, adults with type 2 diabetes were randomized to receive exenatide QWS-AI (2 mg) or exenatide two times per day (5 mcg for 4 weeks, followed by 10 mcg) for 28 weeks. During a subsequent non-randomized 24-week extension, patients who received exenatide two times per day were switched to exenatide QWS-AI and those randomized to exenatide QWS-AI continued this treatment. Efficacy measures included changes from baseline in glycated hemoglobin (A1C), fasting plasma glucose (FPG), and body weight.
RESULTS


In total, 315 patients (mean baseline A1C of 8.5%) completed the initial 28 weeks of randomized treatment with exenatide QWS-AI (n=197) or exenatide two times per day (n=118) and were included in the 24-week extension (mean A1C of 7.0% and 7.3%, respectively, at week 28). From weeks 28-52, patients who switched from exenatide two times per day to exenatide QWS-AI had additional A1C reductions of approximately 0.5% (mean A1C change from baseline of -1.4% at week 52) and further reductions from baseline in FPG. Patients who continued exenatide QWS-AI treatment for 52 weeks showed clinically relevant A1C reductions (mean A1C change from baseline of -1.3% at week 52). Body-weight reductions achieved through week 28 were sustained at week 52 in both groups. There were no unexpected safety concerns or changes in the safety profile among patients who switched from exenatide two times per day to exenatide QWS-AI or those who continued exenatide QWS-AI treatment for 52 weeks.
CONCLUSIONS


Switching from exenatide two times per day to exenatide QWS-AI resulted in further A1C reductions and maintenance of earlier decreases in body weight, while continued therapy with exenatide QWS-AI for 52 weeks maintained A1C and body-weight reductions, without additional safety or tolerability concerns.
TRIAL REGISTRATION NUMBER


NCT01652716.",2020,"Efficacy measures included changes from baseline in glycated hemoglobin (A1C), fasting plasma glucose (FPG), and body weight.
","['adults with type 2 diabetes', 'patients with type 2 diabetes', '315 patients (mean baseline A1C of 8.5%) completed the initial 28 weeks of randomized treatment with']","['exenatide QWS-AI (n=197) or exenatide', 'exenatide', 'exenatide administered by autoinjector (exenatide once-weekly suspension by autoinjector (QWS-AI)) or treatment with exenatide QWS-AI', 'exenatide QWS-AI', 'exenatide QWS-AI (2\u2009mg) or exenatide']","['clinically relevant A1C reductions', 'glycated hemoglobin (A1C), fasting plasma glucose (FPG), and body weight', 'Body-weight reductions', 'glycemic control']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0167117', 'cui_str': 'exenatide'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0558293', 'cui_str': 'Once a week'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",315.0,0.0159734,"Efficacy measures included changes from baseline in glycated hemoglobin (A1C), fasting plasma glucose (FPG), and body weight.
","[{'ForeName': 'Carol H', 'Initials': 'CH', 'LastName': 'Wysham', 'Affiliation': 'Section of Endocrinology and Metabolism, MultiCare Rockwood Clinic, Spokane, Washington, USA cwysham@multicare.org.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Rosenstock', 'Affiliation': 'Dallas Diabetes Research Center at Medical City, Dallas, Texas, USA.'}, {'ForeName': 'Marion L', 'Initials': 'ML', 'LastName': 'Vetter', 'Affiliation': 'Bristol-Myers Squibb, Princeton, New Jersey, USA.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'AstraZeneca, Gaithersburg, Maryland, USA.'}, {'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Hardy', 'Affiliation': 'Late clinical development, AstraZeneca, Gaithersburg, Maryland, USA.'}, {'ForeName': 'Nayyar', 'Initials': 'N', 'LastName': 'Iqbal', 'Affiliation': 'Clinical, Diabetes, Metabolism and GI, AstraZeneca, Gaithersburg, Maryland, USA.'}]",BMJ open diabetes research & care,['10.1136/bmjdrc-2019-000773']
3235,33037080,Baricitinib-associated changes in global gene expression during a 24-week phase II clinical systemic lupus erythematosus trial implicates a mechanism of action through multiple immune-related pathways.,"OBJECTIVE


To characterise the molecular pathways impacted by the pharmacologic effects of the Janus kinase (JAK) 1 and JAK2 inhibitor baricitinib in SLE.
METHODS


In a phase II, 24-week, randomised, placebo-controlled, double-blind study (JAHH), RNA was isolated from whole blood in 274 patients and analysed using Affymetrix HTA2.0 array. Serum cytokines were measured using ultrasensitive quantitative assays.
RESULTS


Gene expression profiling demonstrated an elevation of  STAT1 ,  STAT2  and multiple interferon (IFN) responsive genes at baseline in patients with SLE. Statistical and gene network analyses demonstrated that baricitinib treatment reduced the mRNA expression of functionally interconnected genes involved in SLE including  STAT1 -target,  STAT2 -target and  STAT4- target genes and multiple IFN responsive genes. At baseline, serum cytokines IFN-α, IFN-γ, interleukin (IL)-12p40 and IL-6 were measurable and elevated above healthy controls. Treatment with baricitinib significantly decreased serum IL-12p40 and IL-6 cytokine levels at week 12, which persisted through week 24.
CONCLUSION


Baricitinib treatment induced significant reduction in the RNA expression of a network of genes associated with the JAK/STAT pathway, cytokine signalling and SLE pathogenesis. Baricitinib consistently reduced serum levels of two key cytokines implicated in SLE pathogenesis, IL-12p40 and IL-6.",2020,"Treatment with baricitinib significantly decreased serum IL-12p40 and IL-6 cytokine levels at week 12, which persisted through week 24.
CONCLUSION


Baricitinib treatment induced significant reduction in the RNA expression of a network of genes associated with the JAK/STAT pathway, cytokine signalling and SLE pathogenesis.",['274 patients and analysed using Affymetrix HTA2.0 array'],"['target and  STAT4', 'placebo']","['Serum cytokines', 'serum IL-12p40 and IL-6 cytokine levels', 'elevation of  STAT1 ,  STAT2  and multiple interferon (IFN) responsive genes', 'mRNA expression', 'serum cytokines IFN-α, IFN-γ, interleukin (IL)-12p40 and IL-6', 'global gene expression', 'RNA expression']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0255034', 'cui_str': 'STAT4 Protein'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C1099914', 'cui_str': 'IL12B protein, human'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C1432814', 'cui_str': 'STAT1 protein, human'}, {'cui': 'C0295166', 'cui_str': 'Transcription Factor STAT2'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0205342', 'cui_str': 'Responsive'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0002199', 'cui_str': 'interferon alfa natural'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0040649', 'cui_str': 'Genetic transcription'}]",274.0,0.116982,"Treatment with baricitinib significantly decreased serum IL-12p40 and IL-6 cytokine levels at week 12, which persisted through week 24.
CONCLUSION


Baricitinib treatment induced significant reduction in the RNA expression of a network of genes associated with the JAK/STAT pathway, cytokine signalling and SLE pathogenesis.","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Dörner', 'Affiliation': 'DRFZ Berlin and Department of Rheumatology and Clinical Immunology, Charite University Hospital Berlin, Berlin, Germany thomas.doerner@charite.de.'}, {'ForeName': 'Yoshiya', 'Initials': 'Y', 'LastName': 'Tanaka', 'Affiliation': 'The First Department of Internal Medicine, School of Medicine, University of Occupational & Environmental Health, Kitakyushu, Japan.'}, {'ForeName': 'Michelle A', 'Initials': 'MA', 'LastName': 'Petri', 'Affiliation': 'Division of Rheumatology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Josef S', 'Initials': 'JS', 'LastName': 'Smolen', 'Affiliation': 'Division of Rheumatology, Medical University of Vienna, Wien, Austria.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Wallace', 'Affiliation': 'Department of Rheumatology, Cedars-Sinai Medical Center, West Hollywood, California, USA.'}, {'ForeName': 'Ernst R', 'Initials': 'ER', 'LastName': 'Dow', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Higgs', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Guilherme', 'Initials': 'G', 'LastName': 'Rocha', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Crowe', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Benschop', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Nicole L', 'Initials': 'NL', 'LastName': 'Byers', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Maria E', 'Initials': 'ME', 'LastName': 'Silk', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'de Bono', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Damiano', 'Initials': 'D', 'LastName': 'Fantini', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Hoffman', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}]",Lupus science & medicine,['10.1136/lupus-2020-000424']
3236,33037118,"Avelumab as second-line therapy for metastatic, platinum-treated urothelial carcinoma in the phase Ib JAVELIN Solid Tumor study: 2-year updated efficacy and safety analysis.","BACKGROUND


Anti-programmed cell death ligand 1 (PD-L1)/programmed cell death 1 antibodies have shown clinical activity in platinum-treated metastatic urothelial carcinoma, resulting in regulatory approval of several agents, including avelumab (anti-PD-L1). We report ≥2-year follow-up data for avelumab treatment and exploratory subgroup analyses in patients with urothelial carcinoma.
METHODS


Patients with previously treated advanced/metastatic urothelial carcinoma, pooled from two cohorts of the phase Ib JAVELIN Solid Tumor trial, received avelumab 10 mg/kg every 2 weeks until disease progression, unacceptable toxicity or withdrawal. End points included best overall response and progression-free survival (PFS) per RECIST V.1.1, overall survival (OS) and safety. Post hoc analyses included objective response rates (ORRs) in subgroups defined by established high-risk/poor-prognosis characteristics and association between time to response and outcome.
RESULTS


249 patients received avelumab; efficacy was assessed in 242 postplatinum patients. Median follow-up was 31.9 months (range 24-43), and median treatment duration was 2.8 months (range 0.5-42.8). The confirmed ORR was 16.5% (95% CI 12.1% to 21.8%; complete response in 4.1% and partial response in 12.4%). Median duration of response was 20.5 months (95% CI 9.7 months to not estimable). Median PFS was 1.6 months (95% CI 1.4 to 2.7 months) and the 12-month PFS rate was 16.8% (95% CI 11.9% to 22.4%). Median OS was 7.0 months (95% CI 5.9 to 8.5 months) and the 24-month OS rate was 20.1% (95% CI 15.2% to 25.4%). In post hoc exploratory analyses, avelumab showed antitumor activity in high-risk subgroups, including elderly patients and those with renal insufficiency or upper tract disease; ORRs were numerically lower in patients with liver metastases or low albumin levels. Objective response achieved by 3 months versus later was associated with longer OS (median not reached (95% CI 18.9 months to not estimable) vs 7.1 months (95% CI 5.2 to 9.0 months)). Safety findings were consistent with previously reported 6-month analyses.
CONCLUSIONS


After ≥2 years of follow-up, avelumab showed prolonged efficacy and acceptable safety in patients with platinum-treated advanced/metastatic urothelial carcinoma, including high-risk subgroups. Survival appeared longer in patients who responded within 3 months. Long-term safety findings were consistent with earlier reports with avelumab treatment in this patient population.",2020,Objective response achieved by 3 months versus later was associated with longer OS (median not reached (95% CI 18.9 months to not estimable) vs 7.1 months (95% CI 5.2 to 9.0 months)).,"['242 postplatinum patients', 'Patients with previously treated advanced/metastatic urothelial carcinoma', 'patients with platinum-treated advanced/metastatic urothelial carcinoma, including high-risk subgroups', 'patients with urothelial carcinoma']",[],"['Objective response', 'avelumab; efficacy', 'antitumor activity', 'prolonged efficacy and acceptable safety', 'Median PFS', 'confirmed ORR', 'objective response rates (ORRs', 'Survival', 'overall response and progression-free survival (PFS) per RECIST V.1.1, overall survival (OS) and safety', 'longer OS', 'Median OS', 'Median duration of response', '12-month PFS rate', '24-month OS rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C4288754', 'cui_str': 'Metastatic urothelial carcinoma'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0007138', 'cui_str': 'Transitional cell carcinoma'}]",[],"[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C4055417', 'cui_str': 'avelumab'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",242.0,0.186069,Objective response achieved by 3 months versus later was associated with longer OS (median not reached (95% CI 18.9 months to not estimable) vs 7.1 months (95% CI 5.2 to 9.0 months)).,"[{'ForeName': 'Andrea B', 'Initials': 'AB', 'LastName': 'Apolo', 'Affiliation': 'Hematology Oncology, Oregon Health & Science University, Portland, Oregon, USA andrea.apolo@nih.gov.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Ellerton', 'Affiliation': 'Genitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'Infante', 'Affiliation': 'Nevada Cancer Research Foundation, Las Vegas, Nevada, USA.'}, {'ForeName': 'Manish', 'Initials': 'M', 'LastName': 'Agrawal', 'Affiliation': 'Sarah Cannon Research Institute, Nashville, Tennessee, USA.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Gordon', 'Affiliation': 'Associates in Oncology, Rockville, Maryland, USA.'}, {'ForeName': 'Raid', 'Initials': 'R', 'LastName': 'Aljumaily', 'Affiliation': 'Nevada Cancer Research Foundation, Las Vegas, Nevada, USA.'}, {'ForeName': 'Theodore', 'Initials': 'T', 'LastName': 'Gourdin', 'Affiliation': 'Hematology/Oncology, The University of Oklahoma Stephenson Cancer Center, Oklahoma City, Oklahoma, USA.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Dirix', 'Affiliation': 'Department of Medicine, Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': 'Keun-Wook', 'Initials': 'KW', 'LastName': 'Lee', 'Affiliation': 'Department of Medical Oncology, Sint-Augustinus Hospital Oncology Centre, Antwerp, Belgium.'}, {'ForeName': 'Matthew H', 'Initials': 'MH', 'LastName': 'Taylor', 'Affiliation': 'Department of Internal Medicine, Seoul National University College of Medicine, Seongnam, Republic of Korea.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Schöffski', 'Affiliation': 'Department of General Medical Oncology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Ding', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Henry Ford Cancer Institute, Detroit, Michigan, USA.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Ravaud', 'Affiliation': 'Department of Medical Oncology, Bordeaux University Hospital, Bordeaux, France.'}, {'ForeName': 'Juliane', 'Initials': 'J', 'LastName': 'Manitz', 'Affiliation': 'EMD Serono Research & Development Institute, Inc, Billerica, Massachusetts, USA; a business of Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Pennock', 'Affiliation': 'EMD Serono, Inc, Rockland, Massachusetts, USA; a business of Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Ruisi', 'Affiliation': 'EMD Serono Research & Development Institute, Inc, Billerica, Massachusetts, USA; a business of Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Gulley', 'Affiliation': 'Hematology Oncology, Oregon Health & Science University, Portland, Oregon, USA.'}, {'ForeName': 'Manish R', 'Initials': 'MR', 'LastName': 'Patel', 'Affiliation': 'Florida Cancer Specialists/Sarah Cannon Research Institute, Sarasota, Florida, USA.'}]",Journal for immunotherapy of cancer,['10.1136/jitc-2020-001246']
3237,33037200,Pragmatic trial on inhaled corticosteroid withdrawal in patients with COPD in general practice.,"The therapeutic value of inhaled corticosteroids (ICSs) for COPD is limited. In published RCTs, ICS could be withdrawn in COPD patients without increasing exacerbation risk when bronchodilator treatment is optimized. Here we report on the feasibility and risks of ICS withdrawal in Dutch general practice for COPD patients without an indication for ICSs. In our pragmatic trial, general practitioners decided autonomously which of their COPD patients on ICS treatment could stop this, how this was done, and whether additional bronchodilator therapy was needed. We recruited 62 COPD patients (58 analysed) who were eligible for ICS withdrawal in 79 practices. In 32 patients (55.2%, 95% CI: 42.5-67.3%) ICS was withdrawn successfully, 19 (32.8%, 95% CI: 22.1-45.6%) restarted ICS treatment within six months, 12 patients (20.7%, 95% CI: 12.3-32.8%) had a moderate exacerbation, and one patient had a severe exacerbation. ICS withdrawal was successful in just over half of the patients with COPD without an indication for ICS.",2020,"ICS was withdrawn successfully, 19 (32.8%, 95% CI: 22.1-45.6%) restarted ICS treatment within six months, 12 patients (20.7%, 95% CI: 12.3-32.8%) had a moderate exacerbation, and one patient had a severe exacerbation.","['62 COPD patients (58 analysed) who were eligible for ICS withdrawal in 79 practices', 'Dutch general practice for COPD patients without an indication for ICSs', 'patients with COPD in general practice']",['inhaled corticosteroids (ICSs'],"['ICS', 'exacerbation risk', 'severe exacerbation']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",62.0,0.152709,"ICS was withdrawn successfully, 19 (32.8%, 95% CI: 22.1-45.6%) restarted ICS treatment within six months, 12 patients (20.7%, 95% CI: 12.3-32.8%) had a moderate exacerbation, and one patient had a severe exacerbation.","[{'ForeName': 'Lisette', 'Initials': 'L', 'LastName': 'van den Bemt', 'Affiliation': 'Department of Primary and Community Care, Radboud University Medical Center, Radboud Institute for Health Sciences, Nijmegen, The Netherlands. Lisette.vandenBemt@radboudumc.nl.'}, {'ForeName': 'Lotte', 'Initials': 'L', 'LastName': 'van den Nieuwenhof', 'Affiliation': 'Department of Primary and Community Care, Radboud University Medical Center, Radboud Institute for Health Sciences, Nijmegen, The Netherlands.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Rutjes', 'Affiliation': 'Department of Primary and Community Care, Radboud University Medical Center, Radboud Institute for Health Sciences, Nijmegen, The Netherlands.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'van der Meer', 'Affiliation': 'Budel Medical Centre, Budel, The Netherlands.'}, {'ForeName': 'Gerben', 'Initials': 'G', 'LastName': 'Stege', 'Affiliation': 'Department of Pulmonology, St. Anna Hospital, Geldrop, The Netherlands.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Wensing', 'Affiliation': 'Department of General Practice and Health Services Research, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Teichert', 'Affiliation': 'Department of Clinical Pharmacy and Toxicology, Leiden University Medical Centre, Leiden, The Netherlands.'}, {'ForeName': 'Tjard', 'Initials': 'T', 'LastName': 'Schermer', 'Affiliation': 'Department of Primary and Community Care, Radboud University Medical Center, Radboud Institute for Health Sciences, Nijmegen, The Netherlands.'}]",NPJ primary care respiratory medicine,['10.1038/s41533-020-00198-5']
3238,33037320,Multidimensional analyses reveal modulation of adaptive and innate immune subsets by tuberculosis vaccines.,"We characterize the breadth, function and phenotype of innate and adaptive cellular responses in a prevention of Mycobacterium tuberculosis infection trial. Responses are measured by whole blood intracellular cytokine staining at baseline and 70 days after vaccination with H4:IC31 (subunit vaccine containing Ag85B and TB10.4), Bacille Calmette-Guerin (BCG, a live attenuated vaccine) or placebo (n = ~30 per group). H4:IC31 vaccination induces Ag85B and TB10.4-specific CD4 T cells, and an unexpected NKT like  subset, that expresses IFN-γ, TNF and/or IL-2. BCG revaccination increases frequencies of CD4 T cell subsets that either express Th1 cytokines or IL-22, and modestly increases IFNγ-producing NK cells. In vitro BCG re-stimulation also triggers responses by donor-unrestricted T cells, which may contribute to host responses against mycobacteria. BCG, which demonstrated efficacy against sustained Mycobacterium tuberculosis infection, modulates multiple immune cell subsets, in particular conventional Th1 and Th22 cells, which should be investigated in discovery studies of correlates of protection.",2020,"BCG revaccination increases frequencies of CD4 T cell subsets that either express Th1 cytokines or IL-22, and modestly increases IFNγ-producing NK cells.",[],"['BCG', 'H4:IC31 vaccination', 'H4:IC31 (subunit vaccine containing Ag85B and TB10.4), Bacille Calmette-Guerin (BCG, a live attenuated vaccine) or placebo']","['Ag85B and TB10.4-specific CD4 T cells', 'IFNγ-producing NK cells', 'blood intracellular cytokine staining']",[],"[{'cui': 'C0004886', 'cui_str': 'BCG vaccine'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0887892', 'cui_str': 'Vaccines, Subunit'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0022688', 'cui_str': 'NK-cell'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0175996', 'cui_str': 'Protoplasm'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0038128', 'cui_str': 'Stain'}]",,0.143423,"BCG revaccination increases frequencies of CD4 T cell subsets that either express Th1 cytokines or IL-22, and modestly increases IFNγ-producing NK cells.","[{'ForeName': 'Virginie', 'Initials': 'V', 'LastName': 'Rozot', 'Affiliation': 'South African Tuberculosis Vaccine Initiative, Institute of Infectious Disease & Molecular Medicine and Division of Immunology, Department of Pathology, University of Cape Town, Cape Town, South Africa. virginie.rozot@uct.ac.za.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Nemes', 'Affiliation': 'South African Tuberculosis Vaccine Initiative, Institute of Infectious Disease & Molecular Medicine and Division of Immunology, Department of Pathology, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Hennie', 'Initials': 'H', 'LastName': 'Geldenhuys', 'Affiliation': 'South African Tuberculosis Vaccine Initiative, Institute of Infectious Disease & Molecular Medicine and Division of Immunology, Department of Pathology, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Munyaradzi', 'Initials': 'M', 'LastName': 'Musvosvi', 'Affiliation': 'South African Tuberculosis Vaccine Initiative, Institute of Infectious Disease & Molecular Medicine and Division of Immunology, Department of Pathology, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Asma', 'Initials': 'A', 'LastName': 'Toefy', 'Affiliation': 'South African Tuberculosis Vaccine Initiative, Institute of Infectious Disease & Molecular Medicine and Division of Immunology, Department of Pathology, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Rantangee', 'Affiliation': 'South African Tuberculosis Vaccine Initiative, Institute of Infectious Disease & Molecular Medicine and Division of Immunology, Department of Pathology, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Lebohang', 'Initials': 'L', 'LastName': 'Makhethe', 'Affiliation': 'South African Tuberculosis Vaccine Initiative, Institute of Infectious Disease & Molecular Medicine and Division of Immunology, Department of Pathology, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Mzwandile', 'Initials': 'M', 'LastName': 'Erasmus', 'Affiliation': 'South African Tuberculosis Vaccine Initiative, Institute of Infectious Disease & Molecular Medicine and Division of Immunology, Department of Pathology, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Bilek', 'Affiliation': 'South African Tuberculosis Vaccine Initiative, Institute of Infectious Disease & Molecular Medicine and Division of Immunology, Department of Pathology, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Simbarashe', 'Initials': 'S', 'LastName': 'Mabwe', 'Affiliation': 'South African Tuberculosis Vaccine Initiative, Institute of Infectious Disease & Molecular Medicine and Division of Immunology, Department of Pathology, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Finak', 'Affiliation': 'Fred Hutchinson Cancer Research Center (FHCRC), Seattle, WA, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Fulp', 'Affiliation': 'Fred Hutchinson Cancer Research Center (FHCRC), Seattle, WA, USA.'}, {'ForeName': 'Ann M', 'Initials': 'AM', 'LastName': 'Ginsberg', 'Affiliation': 'AERAS, Rockville, MD, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Hokey', 'Affiliation': 'AERAS, Rockville, MD, USA.'}, {'ForeName': 'Muki', 'Initials': 'M', 'LastName': 'Shey', 'Affiliation': 'Aeras South Africa Endpoint Assay Laboratory, Cape Town, South Africa.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Gurunathan', 'Affiliation': 'Sanofi Pasteur, Swiftwater, PA, USA.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'DiazGranados', 'Affiliation': 'Sanofi Pasteur, Swiftwater, PA, USA.'}, {'ForeName': 'Linda-Gail', 'Initials': 'LG', 'LastName': 'Bekker', 'Affiliation': 'The Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Hatherill', 'Affiliation': 'South African Tuberculosis Vaccine Initiative, Institute of Infectious Disease & Molecular Medicine and Division of Immunology, Department of Pathology, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Scriba', 'Affiliation': 'South African Tuberculosis Vaccine Initiative, Institute of Infectious Disease & Molecular Medicine and Division of Immunology, Department of Pathology, University of Cape Town, Cape Town, South Africa. thomas.scriba@uct.ac.za.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Communications biology,['10.1038/s42003-020-01288-3']
3239,33037726,Comparison of the efficacy and safety of different doses of nifekalant in the instant cardioversion of persistent atrial fibrillation during radiofrequency ablation.,"Nifekalant has been used in the treatment of atrial arrhythmia recently. However, there is no consensus on the preferable nifekalant dose to treat atrial fibrillation (AF). The purpose of this study was to explore efficacy and safety of different doses of nifekalant in the cardioversion of persistent AF. The study was a single-centre, randomized controlled trial. All subjects received nifekalant or placebo intravenously, and the nifekalant was given at the dosage of 0.3, 0.4 or 0.5 mg/kg. Primary efficacy end-point: compared with 0.3 mg group, the rate of cardioversion to sinus rhythm from AF in 0.4 and 0.5 mg group was higher. The 0.4 and 0.5 mg/kg doses were associated with a similar magnitude of efficacy (P > .05). Secondary efficacy end-point: termination rates of AF in the group of 0.4 mg and 0.5 mg were higher than 0.3 mg. Primary safety end-point: the rate of Torsades de Pointes or ventricular fibrillation was numerically lower in the 0.4 mg group than 0.5 mg group (P = .02). Secondary safety end-point: The rates of the majority of other common drug-related adverse events in the group of 0.5 and 0.4 mg were higher than the 0.3 mg group. A 0.4 mg/kg dose of intravenous nifekalant may be recommended during the radiofrequency ablation for persistent AF considering the benefit-risk profile.",2020,Secondary efficacy endpoint: termination rates of AF in the group of 0.4mg and 0.5mg were higher than 0.3mg.,[],"['radiofrequency ablation', 'nifekalant or placebo']","['efficacy and safety', 'rates of the majority of other common drug-related adverse events', 'efficacy endpoint: termination rates of AF', 'rate of cardioversion to sinus rhythm', 'rate of Torsades de Pointes or ventricular fibrillation']",[],"[{'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}, {'cui': 'C2350374', 'cui_str': 'nifekalant'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0013778', 'cui_str': 'Cardioversion'}, {'cui': 'C0232201', 'cui_str': 'Sinus rhythm'}, {'cui': 'C0042510', 'cui_str': 'Ventricular fibrillation'}]",,0.0413866,Secondary efficacy endpoint: termination rates of AF in the group of 0.4mg and 0.5mg were higher than 0.3mg.,"[{'ForeName': 'Zhenyu', 'Initials': 'Z', 'LastName': 'Zhai', 'Affiliation': 'Department of Cardiovascular Medicine, The Second Affiliated Hospital of Nanchang University, Nanchang, China.'}, {'ForeName': 'Zirong', 'Initials': 'Z', 'LastName': 'Xia', 'Affiliation': 'Department of Cardiovascular Medicine, The Second Affiliated Hospital of Nanchang University, Nanchang, China.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Xia', 'Affiliation': 'Department of Cardiovascular Medicine, The Second Affiliated Hospital of Nanchang University, Nanchang, China.'}, {'ForeName': 'Jinzhu', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': 'Department of Cardiovascular Medicine, The Second Affiliated Hospital of Nanchang University, Nanchang, China.'}, {'ForeName': 'Jianxin', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': 'Department of Cardiovascular Medicine, The Second Affiliated Hospital of Nanchang University, Nanchang, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Zhu', 'Affiliation': 'Department of Cardiovascular Medicine, The Second Affiliated Hospital of Nanchang University, Nanchang, China.'}, {'ForeName': 'Qinmei', 'Initials': 'Q', 'LastName': 'Xiong', 'Affiliation': 'Department of Cardiovascular Medicine, The Second Affiliated Hospital of Nanchang University, Nanchang, China.'}, {'ForeName': 'Yanqing', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Department of Cardiovascular Medicine, The Second Affiliated Hospital of Nanchang University, Nanchang, China.'}, {'ForeName': 'Kui', 'Initials': 'K', 'LastName': 'Hong', 'Affiliation': 'Department of Cardiovascular Medicine, The Second Affiliated Hospital of Nanchang University, Nanchang, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiovascular Medicine, The Second Affiliated Hospital of Nanchang University, Nanchang, China.'}, {'ForeName': 'JianHua', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'Department of Cardiovascular Medicine, The Second Affiliated Hospital of Nanchang University, Nanchang, China.'}, {'ForeName': 'Juxiang', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Cardiovascular Medicine, The Second Affiliated Hospital of Nanchang University, Nanchang, China.'}]",Basic & clinical pharmacology & toxicology,['10.1111/bcpt.13513']
3240,33037989,Feasibility of a behavioral intervention using mobile health applications to reduce cardiovascular risk factors in cancer survivors: a pilot randomized controlled trial.,"PURPOSE


Determine the feasibility of a remotely delivered mobile health (mHealth)-supported intervention to improve diet and physical activity in hematologic malignancy survivors.
METHODS


Pilot randomized controlled trial of a 16-week intervention for improving diet and physical activity: individualized goal-setting (daily steps, sodium, saturated fat, added sugar intake) per feedback from mHealth trackers (Fitbit for activity; Healthwatch360 for diet), supplemented by a Facebook peer support group. Controls accessed the trackers without goal-setting or peer support. Everyone received standardized survivorship counseling with tailored advice from a clinician. Actigraphy and food frequency questionnaires assessed activity and diet at baseline and follow-up.
RESULTS


Forty-one participants (51.2% male; median age 45.1 years; 7.0 years from treatment) were randomized (24 intervention; 17 control). Fitbit and Healthwatch360 use were more common among intervention versus control participants (75.0% versus 70.6% and 50.0% versus 17.7% of eligible days, respectively). Most intervention participants (66.7%) engaged with Facebook; overall, 91.7% interacted with the study's mHealth applications. While no comparisons in activity or dietary outcomes between intervention versus control group met statistical significance, the intervention was associated with greater reductions in the targeted dietary factors and improvements in Healthy Eating Index-2015 score, moderate-vigorous physical activity time, and daily steps. Participant retention at 6 months was 90.2%.
CONCLUSIONS


An intervention for cardiovascular risk reduction based on individualized goal-setting enhanced by mHealth and social media peer support was feasible and acceptable among cancer survivors.
IMPLICATIONS FOR CANCER SURVIVORS


Effective and easily disseminated strategies that improve diet and physical activity in this population are needed.
TRIAL REGISTRATION


Registered in ClinicalTrials.gov (NCT03574012) on June 29, 2018.",2020,"Most intervention participants (66.7%) engaged with Facebook; overall, 91.7% interacted with the study's mHealth applications.","['hematologic malignancy survivors', 'cancer survivors', 'Forty-one participants (51.2% male; median age 45.1\xa0years; 7.0\xa0years from treatment']","['standardized survivorship counseling', 'remotely delivered mobile health (mHealth)-supported intervention', 'diet and physical activity: individualized goal-setting (daily steps, sodium, saturated fat, added sugar intake) per feedback from mHealth trackers (Fitbit for activity; Healthwatch360 for diet), supplemented by a Facebook peer support group', 'behavioral intervention using mobile health applications']","['cardiovascular risk factors', 'activity or dietary outcomes', 'Healthy Eating Index-2015 score, moderate-vigorous physical activity time, and daily steps', 'Actigraphy and food frequency questionnaires assessed activity and diet']","[{'cui': 'C0376545', 'cui_str': 'Hematologic neoplasm'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0150598', 'cui_str': 'Goal setting'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0597423', 'cui_str': 'Saturated fat'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0556234', 'cui_str': 'Sugar intake'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0036606', 'cui_str': 'Support Groups'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C4280021', 'cui_str': 'Healthy Eating Index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.0717649,"Most intervention participants (66.7%) engaged with Facebook; overall, 91.7% interacted with the study's mHealth applications.","[{'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Chow', 'Affiliation': 'Fred Hutchinson Cancer Research Center, PO Box 19024, Mailstop M4-C308, Seattle, WA, 98109, USA. ericchow@uw.edu.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Doody', 'Affiliation': 'Fred Hutchinson Cancer Research Center, PO Box 19024, Mailstop M4-C308, Seattle, WA, 98109, USA.'}, {'ForeName': 'Chongzhi', 'Initials': 'C', 'LastName': 'Di', 'Affiliation': 'Fred Hutchinson Cancer Research Center, PO Box 19024, Mailstop M4-C308, Seattle, WA, 98109, USA.'}, {'ForeName': 'Saro H', 'Initials': 'SH', 'LastName': 'Armenian', 'Affiliation': 'City of Hope Medical Center, Duarte, CA, USA.'}, {'ForeName': 'K Scott', 'Initials': 'KS', 'LastName': 'Baker', 'Affiliation': 'Fred Hutchinson Cancer Research Center, PO Box 19024, Mailstop M4-C308, Seattle, WA, 98109, USA.'}, {'ForeName': 'Jonathan B', 'Initials': 'JB', 'LastName': 'Bricker', 'Affiliation': 'Fred Hutchinson Cancer Research Center, PO Box 19024, Mailstop M4-C308, Seattle, WA, 98109, USA.'}, {'ForeName': 'Ajay K', 'Initials': 'AK', 'LastName': 'Gopal', 'Affiliation': 'Fred Hutchinson Cancer Research Center, PO Box 19024, Mailstop M4-C308, Seattle, WA, 98109, USA.'}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Hagen', 'Affiliation': 'Fred Hutchinson Cancer Research Center, PO Box 19024, Mailstop M4-C308, Seattle, WA, 98109, USA.'}, {'ForeName': 'Tyler G', 'Initials': 'TG', 'LastName': 'Ketterl', 'Affiliation': 'Department of Pediatrics, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Stephanie J', 'Initials': 'SJ', 'LastName': 'Lee', 'Affiliation': 'Fred Hutchinson Cancer Research Center, PO Box 19024, Mailstop M4-C308, Seattle, WA, 98109, USA.'}, {'ForeName': 'Kerryn W', 'Initials': 'KW', 'LastName': 'Reding', 'Affiliation': 'Fred Hutchinson Cancer Research Center, PO Box 19024, Mailstop M4-C308, Seattle, WA, 98109, USA.'}, {'ForeName': 'Jeannette M', 'Initials': 'JM', 'LastName': 'Schenk', 'Affiliation': 'Fred Hutchinson Cancer Research Center, PO Box 19024, Mailstop M4-C308, Seattle, WA, 98109, USA.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Syrjala', 'Affiliation': 'Fred Hutchinson Cancer Research Center, PO Box 19024, Mailstop M4-C308, Seattle, WA, 98109, USA.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Taylor', 'Affiliation': 'Fred Hutchinson Cancer Research Center, PO Box 19024, Mailstop M4-C308, Seattle, WA, 98109, USA.'}, {'ForeName': 'Guangxing', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'Fred Hutchinson Cancer Research Center, PO Box 19024, Mailstop M4-C308, Seattle, WA, 98109, USA.'}, {'ForeName': 'Marian L', 'Initials': 'ML', 'LastName': 'Neuhouser', 'Affiliation': 'Fred Hutchinson Cancer Research Center, PO Box 19024, Mailstop M4-C308, Seattle, WA, 98109, USA.'}, {'ForeName': 'Jason A', 'Initials': 'JA', 'LastName': 'Mendoza', 'Affiliation': 'Fred Hutchinson Cancer Research Center, PO Box 19024, Mailstop M4-C308, Seattle, WA, 98109, USA.'}]",Journal of cancer survivorship : research and practice,['10.1007/s11764-020-00949-w']
3241,33038018,Training load but not fatigue affects cross-education of maximal voluntary force.,"The purpose of this study was to determine the effects of training load (25% vs. 75% of one repetition maximum [1RM]) and fatigue (failure vs. non-failure) during four weeks of unilateral knee extension resistance training (RT) on maximal voluntary force in the trained and the untrained knee extensors. Healthy young adults (n = 42) were randomly assigned to control (CON, n = 9, 24 ± 4.3 years), low-load RT to failure (LLF, n = 11, 21 ± 1.3 years, three sets to failure at 25% of 1RM), high-load RT to failure (HLF, n = 11, 21 ± 1.4 years, three sets to failure at 75% of 1RM), and high-load RT without failure (HLNF, n = 11, 22 ± 1.5 years, six sets of five repetitions at 75% of 1RM) groups. Before and after the four weeks of training, 1RM, maximal voluntary isometric force, and corticospinal excitability (CSE) were measured. 1RM in the trained (20%, d = 0.70, 15%, d = 0.61) and the untrained knee extensors (5%, d = 0.27, 6%, d = 0.26) increased only in the HLF and HLNF groups, respectively. MVIC force increased only in the trained leg of the HLF (5%, d = 0.35) and HLNF groups (12%, d = 0.67). CSE decreased in the VL of both legs in the HLNF group (-19%, d = 0.44) and no changes occurred in the RF. In conclusion, high- but not low-load RT improves maximal voluntary force in the trained and the untrained knee extensors and fatigue did not further enhance these adaptations. Voluntary force improvements were unrelated to CSE changes in both legs.",2020,"MVIC force increased only in the trained leg of the HLF (5%, d=0.35) and HLNF groups (12%, d=0.67).","['Healthy young adults (n=42', 'untrained knee extensors']",['unilateral knee extension resistance training (RT'],"['maximal voluntary force', 'CSE', 'MVIC force', '1RM', '1RM, maximal voluntary isometric force (MVIC) and corticospinal excitability (CSE', 'untrained knee extensors']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}]","[{'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0235169', 'cui_str': 'Excitability'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}]",42.0,0.0298528,"MVIC force increased only in the trained leg of the HLF (5%, d=0.35) and HLNF groups (12%, d=0.67).","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Colomer-Poveda', 'Affiliation': 'Department of Physical Education and Sport, Faculty of Sport, Catholic University of Murcia (UCAM), Murcia, Spain.'}, {'ForeName': 'Salvador', 'Initials': 'S', 'LastName': 'Romero-Arenas', 'Affiliation': 'Department of Physical Education and Sport, Faculty of Sport, Catholic University of Murcia (UCAM), Murcia, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Fariñas', 'Affiliation': 'Department of Physical Education and Sport, Faculty of Sports Sciences and Physical Education, University of A Coruna, A Coruna, Spain.'}, {'ForeName': 'Eliseo', 'Initials': 'E', 'LastName': 'Iglesias-Soler', 'Affiliation': 'Department of Physical Education and Sport, Faculty of Sports Sciences and Physical Education, University of A Coruna, A Coruna, Spain.'}, {'ForeName': 'Tibor', 'Initials': 'T', 'LastName': 'Hortobágyi', 'Affiliation': 'Center for Human Movement Sciences, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Gonzalo', 'Initials': 'G', 'LastName': 'Márquez', 'Affiliation': 'Department of Physical Education and Sport, Faculty of Sport, Catholic University of Murcia (UCAM), Murcia, Spain.'}]",Scandinavian journal of medicine & science in sports,['10.1111/sms.13844']
3242,33038051,Effects of a resistance training program in kidney transplant recipients: A randomized controlled trial.,"Kidney transplant recipients are at risk of developing important adverse effects after transplantation. The objective of this study was to investigate the effects of a 10-week supervised resistance exercise-based intervention in kidney transplant recipients. Sixteen participants were randomized to a training (n = 8, 49.7 ± 9.6 years) or control group (n = 8, 48.6 ± 10.6 years). The primary endpoint was health-related quality of life evaluated through the Kidney Disease Quality of Life-Short Form (KDQOL-SF), which includes the 36-Item Short Form Survey (SF-36), and secondary endpoints included physical performance (6-minute walk distance [6-MWD], 60-second sit to stand test [60-STS], 8-foot up and go test, and handgrip and lower limb muscle strength), muscle mass, and biochemical parameters. Endpoints were assessed at baseline and after 10 weeks. Resistance exercise significantly increased (P < .05) some SF-36 domains and tended to induce improvements in one specific KDQOL-SF domain (P = .050). Further, exercise benefits were observed for 6-MWD (9% and 1% for the training and control groups, respectively; P < .001), handgrip strength (7% and -1%; P = .005), 60-STS repetitions (18% and -7%; P < .001), and 8-foot up and go test performance time (-5% and 6%; P = .010). No between-group differences (P > .05) were found for the remaining endpoints. There were no adverse events, musculoskeletal injuries, hypoglycemic episodes, cardiovascular events, or hospitalizations related to the intervention. In conclusion, 10 weeks of supervised resistance training is enough to improve quality of life and physical performance without side effects such as musculoskeletal injuries, hypoglycemic episodes, cardiovascular events, or hospitalizations related to the intervention in kidney transplant recipients.",2020,Resistance exercise significantly increased (p<0.05) some SF-36 domains and tended to induce improvements in one specific KDQOL-SF domain (p=0.050).,"['Kidney transplant recipients', 'Sixteen participants were randomized to a training (n=8, 49.7 ± 9.6 years) or control group (n=8, 48.6 ± 10.6 years', 'kidney transplant recipients']","['supervised resistance exercise-based intervention', 'supervised resistance training', 'resistance training program']","['6-MWD', 'handgrip strength', 'adverse events, musculoskeletal injuries, hypoglycemic episodes, cardiovascular events or hospitalizations', '60-STS repetitions', 'Resistance exercise', 'health-related quality of life (HRQOL) evaluated through the Kidney Disease Quality of Life Short-Form (KDQOL-SF), which includes the 36-Item Short Form Survey (SF-36), and secondary endpoints included physical performance (6-minute walk distance [6-MWD], 60-second sit to stand test [60-STS], 8-foot up and go test, and handgrip and lower limb muscle strength), muscle mass, and biochemical parameters', 'quality of life and physical performance']","[{'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0272448', 'cui_str': 'Injury of musculoskeletal system'}, {'cui': 'C0745153', 'cui_str': 'Hypoglycaemic episode'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",16.0,0.0358587,Resistance exercise significantly increased (p<0.05) some SF-36 domains and tended to induce improvements in one specific KDQOL-SF domain (p=0.050).,"[{'ForeName': 'Sonsoles', 'Initials': 'S', 'LastName': 'Hernández Sánchez', 'Affiliation': 'Department of Physical and Sports Education, School of Sports Science, PROmoting FITness and Health through Physical Activity Research Group (PROFITH), Sport and Health University Research Institute (iMUDS), University of Granada, Granada, Spain.'}, {'ForeName': 'Juan J', 'Initials': 'JJ', 'LastName': 'Carrero', 'Affiliation': 'Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Javier S', 'Initials': 'JS', 'LastName': 'Morales', 'Affiliation': 'Faculty of Sport Science, Universidad Europea de Madrid, Madrid, Spain.'}, {'ForeName': 'Jonatan R', 'Initials': 'JR', 'LastName': 'Ruiz', 'Affiliation': 'Department of Physical and Sports Education, School of Sports Science, PROmoting FITness and Health through Physical Activity Research Group (PROFITH), Sport and Health University Research Institute (iMUDS), University of Granada, Granada, Spain.'}]",Scandinavian journal of medicine & science in sports,['10.1111/sms.13853']
3243,33038066,A high salt meal does not impair cerebrovascular reactivity in healthy young adults.,"A high sodium (Na +  ) meal impairs peripheral vascular function. In rodents, chronic high dietary Na +  impairs cerebral vascular function, and in humans, habitual high dietary Na +  is associated with increased stroke risk. However, the effects of acute high dietary Na +  on the cerebral vasculature in humans are unknown. The purpose of this study was to determine if acute high dietary Na +  impairs cerebrovascular reactivity in healthy adults. Thirty-seven participants (20F/17M; 25 ± 5 years; blood pressure [BP]: 107 ± 9/61 ± 6 mm Hg) participated in this randomized, cross-over study. Participants were given a low Na +  meal (LSM; 138 mg Na +  ) and a high Na +  meal (HSM; 1,495 mg Na +  ) separated by ≥ one week. Serum Na +  , beat-to-beat BP, middle cerebral artery velocity (transcranial Doppler), and end-tidal carbon dioxide (P ET  CO 2  ) were measured pre- (baseline) and 60 min post-prandial. Cerebrovascular reactivity was assessed by determining the percent change in middle cerebral artery velocity to hypercapnia (via 8% CO 2  , 21% oxygen, balance nitrogen) and hypocapnia (via mild hyperventilation). Peripheral vascular function was measured using brachial artery flow-mediated dilation (FMD). Changes in serum Na +  were greater following the HSM (HSM: Δ1.6 ± 1.2 mmol/L vs. LSM: Δ0.7 ± 1.2 mmol/L, p < .01). Cerebrovascular reactivity to hypercapnia (meal effect: p = .41) and to hypocapnia (meal effect: p = .65) were not affected by the HSM. Contrary with previous findings, FMD was not reduced following the HSM (meal effect: p = .74). These data suggest that a single high Na +  meal does not acutely impair cerebrovascular reactivity, and suggests that despite prior findings, a single high Na +  meal does not impair peripheral vascular function in healthy adults.",2020,"Contrary with previous findings, FMD was not reduced following the HSM (meal effect: p = .74).","['healthy young adults', 'Thirty-seven participants (20F/17M; 25\xa0±\xa05\xa0years; blood pressure [BP]: 107\xa0±\xa09/61\xa0±\xa06\xa0mm\xa0Hg', 'healthy adults']","['high Na +  meal (HSM; 1,495\xa0mg Na +  ) separated by\xa0≥\xa0one week', 'sodium (Na +  ) meal', 'dietary Na ', 'low Na +  meal (LSM; 138']","['Serum Na +  , beat-to-beat BP, middle cerebral artery velocity (transcranial Doppler), and end-tidal carbon dioxide (P ET  CO 2  ', 'Cerebrovascular reactivity to hypercapnia', 'Peripheral vascular function', 'brachial artery flow-mediated dilation (FMD', 'middle cerebral artery velocity to hypercapnia', 'cerebrovascular reactivity', 'Cerebrovascular reactivity', 'Changes in serum Na ', 'peripheral vascular function']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C4319569', 'cui_str': '37'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0205251', 'cui_str': 'Low'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0149566', 'cui_str': 'Structure of middle cerebral artery'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0206077', 'cui_str': 'Transcranial doppler ultrasonography'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0020440', 'cui_str': 'Hypercapnia'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0006087', 'cui_str': 'Structure of brachial artery'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0016052', 'cui_str': 'Fibromuscular dysplasia'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",37.0,0.0392972,"Contrary with previous findings, FMD was not reduced following the HSM (meal effect: p = .74).","[{'ForeName': 'Kamila U', 'Initials': 'KU', 'LastName': 'Migdal', 'Affiliation': 'Department of Kinesiology & Applied Physiology, University of Delaware, Newark, DE, USA.'}, {'ForeName': 'Austin T', 'Initials': 'AT', 'LastName': 'Robinson', 'Affiliation': 'Department of Kinesiology & Applied Physiology, University of Delaware, Newark, DE, USA.'}, {'ForeName': 'Joseph C', 'Initials': 'JC', 'LastName': 'Watso', 'Affiliation': 'Department of Kinesiology & Applied Physiology, University of Delaware, Newark, DE, USA.'}, {'ForeName': 'Matthew C', 'Initials': 'MC', 'LastName': 'Babcock', 'Affiliation': 'Department of Kinesiology & Applied Physiology, University of Delaware, Newark, DE, USA.'}, {'ForeName': 'Shannon L', 'Initials': 'SL', 'LastName': 'Lennon', 'Affiliation': 'Department of Kinesiology & Applied Physiology, University of Delaware, Newark, DE, USA.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Martens', 'Affiliation': 'Department of Kinesiology & Applied Physiology, University of Delaware, Newark, DE, USA.'}, {'ForeName': 'Jorge M', 'Initials': 'JM', 'LastName': 'Serrador', 'Affiliation': 'Department of Pharmacology, Physiology & Neuroscience, Rutgers New Jersey Medical School, Newark, NJ, USA.'}, {'ForeName': 'William B', 'Initials': 'WB', 'LastName': 'Farquhar', 'Affiliation': 'Department of Kinesiology & Applied Physiology, University of Delaware, Newark, DE, USA.'}]",Physiological reports,['10.14814/phy2.14585']
3244,33035274,"Programmatic evaluation of feasibility and efficiency of at birth and 6-week, point of care HIV testing in Kenyan infant.","BACKGROUND


Testing infants at birth and with more efficient point of care (POC) HIV diagnostic can streamline EID and expedite infant ART initiation. We evaluated the implementation of at birth and 6-week POC testing to assess the effectiveness and feasibility when implemented by existing hospital staff in Kenya.
METHODS


Four government hospitals were randomly assigned to receive a GeneXpert HIV-1 Qual (n = 2) or Alere m-PIMA (n = 2) machine for POC testing. All HIV-exposed infants enrolled were eligible to receive POC testing at birth and 6-weeks of age. The primary outcome was repeat POC testing, defined as testing both at birth and 6-weeks of age. Secondary outcomes included predictors of repeat POC testing, POC efficiency (turnaround times of key services), and operations (failed POC results, missed opportunities).
RESULTS


Of 626 enrolled infants, 309 (49.4%) received repeat POC testing, 115 (18.4%) were lost to follow up after an at-birth test, 120 (19.2%) received POC testing at 6-weeks only, 80 (12.8%) received no POC testing, and 2 (0.3%) received delayed POC testing (>12 weeks of age). Three (0.4%) were identified as HIV-positive. Of the total 853 POC tests run at birth (n = 424) or 6-weeks (n = 429), 806 (94.5%) had a valid result documented and 792 (98.3%) results had documented maternal notification. Mean time from sample collection to notification was 1.08 days, with 751 (94.8%) notifications on the same day as sample collection. Machine error rates at birth and 6-weeks were 8.5% and 2.5%, respectively. A total of 198 infants presented for care (48 at birth; 150 at 6-weeks) without receiving a POC test, representing missed opportunities for testing.
DISCUSSION


At birth POC testing can streamline infant HIV diagnosis, expedite ART initiation and can be implemented by existing hospital staff. However, maternal disengagement and missed opportunities for testing must be addressed to realize the full benefits of at birth POC testing.",2020,"At birth POC testing can streamline infant HIV diagnosis, expedite ART initiation and can be implemented by existing hospital staff.","['Four government hospitals', 'Kenyan infant', 'All HIV-exposed infants enrolled were eligible to receive POC testing at birth and 6-weeks of age', '626 enrolled infants, 309 (49.4%) received', '198 infants presented for care (48 at birth; 150 at 6-weeks) without receiving a POC test, representing missed opportunities for testing']","['GeneXpert HIV-1 Qual (n = 2) or Alere m-PIMA (n = 2) machine for POC testing', 'delayed POC testing']","['Machine error rates', 'maternal notification', 'repeat POC testing', 'repeat POC testing, defined as testing both at birth and 6-weeks of age', 'Mean time', 'POC testing', 'repeat POC testing, POC efficiency (turnaround times of key services), and operations (failed POC results, missed opportunities']","[{'cui': 'C0337960', 'cui_str': 'Government hospital'}, {'cui': 'C0337839', 'cui_str': 'Kenyans'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C1319069', 'cui_str': 'Point of care testing'}, {'cui': 'C1744681', 'cui_str': 'Congenital'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C2924612', 'cui_str': 'Cephalometric point A'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0392366', 'cui_str': 'Tests'}]","[{'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C0722638', 'cui_str': 'Pima brand of potassium iodide'}, {'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C1319069', 'cui_str': 'Point of care testing'}]","[{'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0422202', 'cui_str': 'Notifications'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C1319069', 'cui_str': 'Point of care testing'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1744681', 'cui_str': 'Congenital'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0282664', 'cui_str': 'Point-of-Care'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]",626.0,0.0931997,"At birth POC testing can streamline infant HIV diagnosis, expedite ART initiation and can be implemented by existing hospital staff.","[{'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Wexler', 'Affiliation': 'Department of Family Medicine, University of Kansas Medical Center, Kansas City, KS, United States of America.'}, {'ForeName': 'Niaman', 'Initials': 'N', 'LastName': 'Nazir', 'Affiliation': 'Department of Preventive Medicine, University of Kansas Medical Center, Kansas City, KS, United States of America.'}, {'ForeName': 'May', 'Initials': 'M', 'LastName': 'Maloba', 'Affiliation': 'Global Health Innovations-Kenya, Nairobi, Kenya.'}, {'ForeName': 'Melinda', 'Initials': 'M', 'LastName': 'Brown', 'Affiliation': 'Department of Family Medicine, University of Kansas Medical Center, Kansas City, KS, United States of America.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Goggin', 'Affiliation': ""Children's Mercy Kansas City, Health Services and Outcomes Research, Kansas City, MO, United States of America.""}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Gautney', 'Affiliation': 'Global Health Innovations, Dallas, TX, United States of America.'}, {'ForeName': 'Nicodemus', 'Initials': 'N', 'LastName': 'Maosa', 'Affiliation': 'Global Health Innovations-Kenya, Nairobi, Kenya.'}, {'ForeName': 'Shadrack', 'Initials': 'S', 'LastName': 'Babu', 'Affiliation': 'Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Muchoki', 'Affiliation': 'Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Natabhona', 'Initials': 'N', 'LastName': 'Mabachi', 'Affiliation': 'Department of Family Medicine, University of Kansas Medical Center, Kansas City, KS, United States of America.'}, {'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Lwembe', 'Affiliation': 'Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Finocchario-Kessler', 'Affiliation': 'Department of Family Medicine, University of Kansas Medical Center, Kansas City, KS, United States of America.'}]",PloS one,['10.1371/journal.pone.0240621']
3245,33035599,Liraglutide or insulin glargine treatments improves hepatic fat in obese patients with type 2 diabetes and nonalcoholic fatty liver disease in twenty-six weeks: A randomized placebo-controlled trial.,"BACKGROUND


Type 2 diabetes mellitus is closely related to nonalcoholic fatty liver disease(NAFLD). More and more attention has been paid to the efficacy of liraglutide in the treatment of NAFLD, but the clinical evidence is still insufficient.
OBJECTIVE


The purpose of this study was to use proton magnetic resonance spectroscopy (H-MRS) assessment of metformin alone poor blood glucose control of obese patients type 2 diabetes with NAFLD, added with insulin glargine, liraglutide or placebo effect in improving the fatty liver.
METHODS


This is a 26-week, single-center, prospective, randomized placebo-controlled study. From September 2016 to July 2018, 128 patients with type 2 diabetes and NAFLD were enrolled in the China joint logistics team 900 hospital. The primary endpoints were the changes in intrahepatic content of lipid (IHCL), abdominal adiposity [subcutaneous adipose tissue (SAT) and visceral adipose tissue (VAT)], from baseline to week 26 (end of treatment) and the changes in liraglutide group or insulin glargine group versus change in placebo group. Secondary endpoints included the changes in liver function (AST and ALT), glycemia (HbA1c and FPG), body weight, and BMI.
RESULTS


A total of 96 patients with type 2 diabetes and NAFLD under inadequate glycemic control by metformin were randomized (1:1:1) to receive add-on insulin glargine, liraglutide, or placebo. After 26 weeks of treatment, compared to the placebo group, in the liraglutide and insulin glargine groups, IHCL significantly decreased from baseline to week 26 (liraglutide 26.4% ± 3.2% to 20.6% ± 3.9%, P < 0.05; insulin glargine 25.0% ± 4.3% to 22.6% ± 5.8%, P > 0.05). SAT and VAT decreased significantly in the liraglutide group and in the insulin glargine group (P < 0.05). ΔSAT and ΔVAT were greater with liraglutide than insulin glargine, they were significantly different between the two groups (ΔSAT, -36 vs. - 24.5, P < 0.05; and ΔVAT, -47 vs. - 16.6, P > 0.05). In the liraglutide group, AST, ALT, and HOMA-IR decreased significantly from baseline. There was no significant difference in glucose-lowering among the three groups. During the treatment, the safety of the three groups performed well.
CONCLUSION


Compared with placebo, treatment with liraglutide plus an adequate dose of metformin (2000 g/ day) for 26 weeks is more effective in reducing IHCL, SAT and VAT in patients with type 2 diabetes and NAFLD. And it has additional advantages in weight loss, waist circumference reduction and liver function improvement.",2020,"ΔSAT and ΔVAT were greater with liraglutide than insulin glargine, they were significantly different between the two groups (ΔSAT, -36 vs.-24.5, P < 0.05; and ΔVAT, -47 vs.-16.6, P > 0.05).","['From September 2016 to July 2018, 128 patients with type 2 diabetes and NAFLD were enrolled in the China joint logistics team 900 hospital', 'patients with type 2 diabetes and NAFLD', '96 patients with type 2 diabetes and NAFLD under inadequate glycemic control by', 'obese patients with type 2 diabetes and nonalcoholic fatty liver disease in twenty-six weeks', 'obese patients type 2 diabetes with NAFLD, added with']","['insulin glargine, liraglutide or placebo', 'proton magnetic resonance spectroscopy (H-MRS', 'liraglutide', 'insulin glargine, liraglutide, or placebo', 'metformin', 'placebo', 'insulin glargine', 'liraglutide and insulin glargine', 'Liraglutide or insulin glargine treatments']","['changes in intrahepatic content of lipid (IHCL), abdominal adiposity [subcutaneous adipose tissue (SAT) and visceral adipose tissue (VAT', 'changes in liver function (AST and ALT), glycemia (HbA1c and FPG), body weight, and BMI', 'blood glucose control', 'weight loss, waist circumference reduction and liver function improvement', 'hepatic fat', 'SAT and VAT', 'glucose-lowering', 'ΔSAT and ΔVAT', 'IHCL, SAT and VAT', 'IHCL', 'AST, ALT, and HOMA-IR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0242415', 'cui_str': 'Logistics'}, {'cui': 'C4517900', 'cui_str': '900'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0332298', 'cui_str': 'Controlled by'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}]","[{'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3850002', 'cui_str': '1H-MRS'}, {'cui': 'C0024487', 'cui_str': 'Magnetic resonance spectroscopy'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0222331', 'cui_str': 'Subcutaneous fatty tissue'}, {'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}]",96.0,0.0676648,"ΔSAT and ΔVAT were greater with liraglutide than insulin glargine, they were significantly different between the two groups (ΔSAT, -36 vs.-24.5, P < 0.05; and ΔVAT, -47 vs.-16.6, P > 0.05).","[{'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Guo', 'Affiliation': '900 Hospital of the Joint Logistics Team, Fuzong Clinical Medical College of Fujian Medical University, Fuzhou 365000, Fujian, China.'}, {'ForeName': 'Wenjun', 'Initials': 'W', 'LastName': 'Tian', 'Affiliation': '900 Hospital of the Joint Logistics Team, Fuzong Clinical Medical College of Fujian Medical University, Fuzhou 365000, Fujian, China.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Lin', 'Affiliation': '900 Hospital of the Joint Logistics Team, Fuzong Clinical Medical College of Fujian Medical University, Fuzhou 365000, Fujian, China.'}, {'ForeName': 'Xiangjin', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': '900 Hospital of the Joint Logistics Team, Fuzong Clinical Medical College of Fujian Medical University, Fuzhou 365000, Fujian, China. Electronic address: xu98111@163.com.'}]",Diabetes research and clinical practice,['10.1016/j.diabres.2020.108487']
3246,33035700,"Pharmacokinetics of indacaterol, glycopyrronium and mometasone furoate following once-daily inhalation as a combination in healthy subjects.","Indacaterol (IND), is co-formulated with glycopyrronium (GLY), and mometasone furoate (MF) as a once-daily (o.d.) inhaled fixed-dose combination (IND/GLY/MF) delivered via the Breezhaler® device for maintenance treatment of asthma. We evaluated the steady state plasma pharmacokinetics (PK) of IND, GLY and MF following inhalation of IND/GLY/MF or as monotherapies. This was a randomized, open-label, four-way crossover study. Subjects received IND/GLY/MF 150/50/160 μg (high-dose), IND 150 μg, GLY 50 μg or MF 190 μg (in vitro fine particle mass comparable to 160 μg MF in IND/GLY/MF) via the Breezhaler® device, o.d. for 14 days in each period, with a washout of at least 7 days. PK was characterized on Day 14, up to 24 h post-dose. In total, 36 healthy subjects were randomized. For IND, the geometric mean ratios (90% CI) for AUC0-24h,ss and Cmax,ss were 0.922 (0.878, 0.969) and 1.02 (0.967, 1.08), respectively for the IND/GLY/MF versus IND monotherapy comparison. For GLY, the geometric mean ratios (90% CI) for AUC0-24h,ss and Cmax,ss were 0.986 (0.944, 1.03) and 1.21 (1.09, 1.34), respectively for the IND/GLY/MF versus GLY comparison. For MF, the geometric mean ratios (90% CI) for AUC0-24h,ss and Cmax,ss were 1.16 (1.09, 1.24) and 1.17 (1.09, 1.25), respectively for IND/GLY/MF versus MF comparison. Similar systemic exposure was noted for IND/GLY/MF versus monotherapy for all three mono-components, indicating a lack of PK interaction. Multiple inhaled doses of IND, GLY and MF were safe and well tolerated, when administered alone or in combination. There was no clinically relevant pharmacokinetic interaction between IND, GLY and MF when administered as IND/GLY/MF.",2020,"For MF, the geometric mean ratios (90% CI) for AUC0-24h, ss and Cmax, ss were 1.16 (1.09, 1.24) and 1.17 (1.09, 1.25), respectively for IND/GLY/MF versus MF comparison.","['36 healthy subjects', 'healthy subjects']","['glycopyrronium (GLY), and mometasone furoate (MF', 'IND/GLY/MF', 'inhaled fixed-dose combination (IND/GLY/MF) delivered via the Breezhaler® device', 'IND, GLY and MF', 'Indacaterol (IND', 'indacaterol, glycopyrronium and mometasone furoate']","['geometric mean ratios', 'steady state plasma pharmacokinetics (PK) of IND, GLY and MF following inhalation of IND/GLY/MF', 'safe and well tolerated']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C3814772', 'cui_str': 'glycopyrronium'}, {'cui': 'C0066700', 'cui_str': 'Mometasone furoate'}, {'cui': 'C1722260', 'cui_str': 'indacaterol'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C1722260', 'cui_str': 'indacaterol'}, {'cui': 'C3814772', 'cui_str': 'glycopyrronium'}, {'cui': 'C0066700', 'cui_str': 'Mometasone furoate'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}]",36.0,0.0285696,"For MF, the geometric mean ratios (90% CI) for AUC0-24h, ss and Cmax, ss were 1.16 (1.09, 1.24) and 1.17 (1.09, 1.25), respectively for IND/GLY/MF versus MF comparison.","[{'ForeName': 'Soniya', 'Initials': 'S', 'LastName': 'Vaidya', 'Affiliation': 'Novartis Institutes for BioMedical Research, Cambridge, USA.'}, {'ForeName': 'Juergen', 'Initials': 'J', 'LastName': 'Jauernig', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Ethell', 'Affiliation': 'Novartis Institutes for BioMedical Research, Cambridge, USA.'}, {'ForeName': 'Nasri', 'Initials': 'N', 'LastName': 'Abdallah', 'Affiliation': 'Novartis Institutes for BioMedical Research, Translational Medicine, Basel, Switzerland.'}, {'ForeName': 'Surendra', 'Initials': 'S', 'LastName': 'Machineni', 'Affiliation': 'Novartis Healthcare Pvt. Ltd., Hyderabad, India.'}, {'ForeName': 'Anton', 'Initials': 'A', 'LastName': 'Drollmann', 'Affiliation': 'Novartis Institutes for BioMedical Research, Translational Medicine, Basel, Switzerland.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Heudi', 'Affiliation': 'Novartis Institutes for BioMedical Research, Translational Medicine, Basel, Switzerland.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Last', 'Affiliation': 'Charité Research Organisation GmbH, Berlin, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hahn', 'Affiliation': 'Novartis Institutes for BioMedical Research, Translational Medicine, Basel, Switzerland.'}, {'ForeName': 'Rajkumar', 'Initials': 'R', 'LastName': 'Radhakrishnan', 'Affiliation': 'Novartis Healthcare Pvt. Ltd., Hyderabad, India.'}, {'ForeName': 'Stanislav', 'Initials': 'S', 'LastName': 'Ignatenko', 'Affiliation': 'Charité Research Organisation GmbH, Berlin, Germany.'}, {'ForeName': 'Hanns-Christian', 'Initials': 'HC', 'LastName': 'Tillmann', 'Affiliation': 'Novartis Institutes for BioMedical Research, Translational Medicine, Basel, Switzerland. Electronic address: hanns-christian.tillmann@novartis.com.'}]",Pulmonary pharmacology & therapeutics,['10.1016/j.pupt.2020.101964']
3247,33046075,Effect of health education on knowledge and attitude of menopause among middle-age teachers.,"BACKGROUND


Adequate knowledge and positive attitude toward menopause are important for women to tackle changes related to menopause. Even though all women experience menopause at some stage in their life, teachers face more difficulties more than other female employees due to the nature of their roles do. In Eritrea, menopause has been given little attention hence gaps exist concerning women's knowledge, attitude, and the effects of health education on the same subject. This study aimed at assessing the effect of health education on knowledge and attitude of menopause among middle-aged teachers in elementary, junior, and secondary schools of Asmara, Eritrea.
METHOD


A semi-experimental design with pre-intervention, immediate post-intervention, and three-month follow up test was used in this study. The data was collected from 99 middle age teachers using stratified random sampling. The intervention was done using lectures, group discussions, brochures, and handouts. Data on socio-demographics, knowledge, and attitude was collected using a pre-designed questionnaire. The effect of educational training at the three-time points was evaluated by repeated measure ANOVA using SPSS version 22.
RESULTS


The mean scores of correct knowledge at pre-intervention, immediate post-intervention, and 3-months follow-up were 12.3/22 (SD = 3.06), 17.3/22 (SD = 3.21), and 16.5/22 (SD = 2.52) respectively. A significant difference in scores of knowledge at the three-time points was observed due to the educational intervention with a statistical significance of (p <  0.0001). Post-hoc analysis revealed that knowledge score immediately after intervention was significantly greater than that of pre-intervention (p <  0.0001), and 3-months follow-up (p = 0.004). The mean scores of attitude at the three-time points were 27.9/45 (SD = 5.14), 28.3/45(SD = 5.25), 28.32/45(SD = 5.12). The educational intervention had brought a change in the mean scores of attitude at the three-time point with a statistical significance of (p < 0.0001). Post-hoc analysis revealed that attitude scores at immediate post-intervention were also significant (p = 0.001) with the 3-months follow up at (p < 0.0001) were higher than that of pre-intervention.
CONCLUSION


The structured educational intervention was beneficial to the studied women in intensifying their knowledge and tuning them toward a positive attitude. Hence, proper health education programs regarding menopause are strongly recommended.",2020,The educational intervention had brought a change in the mean scores of attitude at the three-time point with a statistical significance of (p < 0.0001).,"['middle-aged teachers in elementary, junior, and secondary schools of Asmara, Eritrea', '99 middle age teachers using stratified random sampling', 'among middle-age teachers']","['health education', 'educational training', 'structured educational intervention']","['knowledge score', 'mean scores of correct knowledge', 'socio-demographics, knowledge, and attitude', 'attitude scores', 'knowledge and attitude of menopause', 'mean scores of attitude', 'scores of knowledge']","[{'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0036530', 'cui_str': 'Secondary school'}, {'cui': 'C0014716', 'cui_str': 'Eritrea'}, {'cui': 'C0026062', 'cui_str': 'Middle-age'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}]",99.0,0.0226518,The educational intervention had brought a change in the mean scores of attitude at the three-time point with a statistical significance of (p < 0.0001).,"[{'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Gebretatyos', 'Affiliation': 'Department of Midwifery, School of Nursing, Asmara College of Health Sciences, Asmara, Eritrea. gebretatyoshelen@gmail.com.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Ghirmai', 'Affiliation': 'Department of Midwifery, School of Nursing, Asmara College of Health Sciences, Asmara, Eritrea.'}, {'ForeName': 'Soliana', 'Initials': 'S', 'LastName': 'Amanuel', 'Affiliation': 'Department of Midwifery, School of Nursing, Asmara College of Health Sciences, Asmara, Eritrea.'}, {'ForeName': 'Ghidey', 'Initials': 'G', 'LastName': 'Gebreyohannes', 'Affiliation': 'Dean of Asmara College of Health Sciences, Asmara, Eritrea.'}, {'ForeName': 'Zemenfes', 'Initials': 'Z', 'LastName': 'Tsighe', 'Affiliation': 'Dean of Asmara College of Health Sciences, Asmara, Eritrea.'}, {'ForeName': 'Eyasu H', 'Initials': 'EH', 'LastName': 'Tesfamariam', 'Affiliation': 'Department of Statistics, Biostatistics and Epidemiology Unit, College of Science, Mai Nefhi, Eritrea.'}]",BMC women's health,['10.1186/s12905-020-01095-2']
3248,33046094,A pilot cluster randomised trial of the medicines and alcohol consultation (MAC): an intervention to discuss alcohol use in community pharmacy medicine review services.,"BACKGROUND


Alcohol interventions are important to the developing public health role of community pharmacies. The Medicines and Alcohol Consultation (MAC) is a new intervention, co-produced with community pharmacists (CPs) and patients, which involves a CP practice development programme designed to integrate discussion of alcohol within existing NHS medicine review services. We conducted a pilot trial of the MAC and its delivery to investigate all study procedures to inform progression to a definitive trial.
METHODS


This cluster pilot RCT was conducted in 10 community pharmacies in Yorkshire, UK, with a CP from each who regularly conducted Medicine Use Review (MUR) and New Medicine Service (NMS) consultations. Randomisation was conducted using a secure remote randomisation service. Intervention CPs (n = 5) were trained to deliver the MAC in MUR/NMS consultations. Control CPs (n = 5) provided these services as usual. Consecutive MUR/NMS patients were asked by CPs to participate, screened for eligibility (consumption of alcohol at least twice per week), and baseline data collected for those eligible. A two-month follow-up telephone interview was conducted. Blinding of CPs was not possible, but patients were blinded to the alcohol focus of the trial. Primary outcomes were total weekly UK units (8 g of ethanol per unit) of alcohol consumption in the week prior to follow-up, and confidence in medications management. Trial procedures were assessed by recruitment, attrition, and follow-up rates.
RESULTS


260 patients were approached by CPs to take part in the trial, 68% (n = 178) were assessed for eligibility and 30% (n = 54) of these patients were eligible. Almost all eligible patients (n = 51; 94%) consented to participate, of whom 92% (n = 47) were followed-up at 2 months; alcohol consumption was lower in the intervention arm and confidence in medication management reduced slightly for both groups. Exploration of recall issues at follow-up showed a high level of agreement between a two-item quantity/frequency measure and 7-day guided recall of alcohol consumption.
CONCLUSIONS


The pilot trial demonstrates the feasibility of implementing the MAC in community pharmacy and trial recruitment and data collection procedures. However, decommissioning of MURs means that it is not possible to conduct a definitive trial of the intervention in this service.
TRIAL REGISTRATION


ISRCTN57447996.",2020,"Exploration of recall issues at follow-up showed a high level of agreement between a two-item quantity/frequency measure and 7-day guided recall of alcohol consumption.
","['260 patients were approached by CPs to take part in the trial, 68% (n\u2009=\u2009178) were assessed for eligibility and 30% (n\u2009=\u200954) of these patients were eligible', '10 community pharmacies in Yorkshire, UK, with a CP from each who regularly conducted Medicine Use Review (MUR) and New Medicine Service (NMS) consultations']","['MAC', 'Medicines and Alcohol Consultation (MAC', 'Control CPs', 'medicines and alcohol consultation (MAC']","['alcohol consumption', 'total weekly UK units (8\u2009g of ethanol per unit) of alcohol consumption in the week prior to follow-up, and confidence in medications management']","[{'cui': 'C4517669', 'cui_str': '260'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0402003', 'cui_str': 'Community pharmacist'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0009478', 'cui_str': 'Community Pharmacies'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0402003', 'cui_str': 'Community pharmacist'}]","[{'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C1318217', 'cui_str': '8G'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0150270', 'cui_str': 'Management of drug regimen'}]",260.0,0.0535451,"Exploration of recall issues at follow-up showed a high level of agreement between a two-item quantity/frequency measure and 7-day guided recall of alcohol consumption.
","[{'ForeName': 'Duncan', 'Initials': 'D', 'LastName': 'Stewart', 'Affiliation': 'Department of Health Sciences, University of York, York, UK. d.stewart@londonmet.ac.uk.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'van Dongen', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Watson', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Mandefield', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Atkin', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Ranjita', 'Initials': 'R', 'LastName': 'Dhital', 'Affiliation': 'Department of Pharmacy, University of Reading, Reading, UK.'}, {'ForeName': 'Brent', 'Initials': 'B', 'LastName': 'Foster', 'Affiliation': 'Whitworths Chemists Ltd, Scunthorpe, UK.'}, {'ForeName': 'Brendan', 'Initials': 'B', 'LastName': 'Gough', 'Affiliation': 'School of Social Sciences, Leeds Beckett University, Leeds, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Hewitt', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Madden', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Morris', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Ronan', 'Initials': 'R', 'LastName': ""O'Carroll"", 'Affiliation': 'Department of Psychology, Stirling University, Stirling, UK.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Ogden', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Parrott', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Watson', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'White', 'Affiliation': 'North of England Commissioning Support (NECS), Newcastle, UK.'}, {'ForeName': 'Cate', 'Initials': 'C', 'LastName': 'Whittlesea', 'Affiliation': 'UCL School of Pharmacy, University College London, London, UK.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'McCambridge', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}]",BMC health services research,['10.1186/s12913-020-05797-z']
3249,33046115,The effect of breastfeeding education with grandmothers' attendance on breastfeeding self-efficacy and infant feeding pattern in Iranian primiparous women: a quasi-experimental pilot study.,"BACKGROUND


One of the most important factors that affects breastfeeding self-efficacy and exclusivity is breastfeeding support provided by the family. The aim of this study was to determine the effect of breastfeeding education sessions for primiparous women, with and without the attendance of maternal grandmothers, on breastfeeding self-efficacy and infant feeding patterns.
METHODS


This quasi-experimental study was conducted on 64 primiparous women who referred to the Antenatal Clinic of Amiralmomenin Hospital, Tehran, Iran from June to December, 2018. Eligible pregnant women were allocated into two groups; either with and without grandmothers in attendance. Group assignments were determined according to the week the women had prenatal care at the hospital. All eligible women seen in the clinic during 1 week were assigned to one group and women who presented in the alternating week were assigned to the other group. In the education group with grandmothers in attendance, each woman participated in two prenatal education programs with her mother and one postpartum program approximately 3 h before discharge. In the other group, participating mothers attended breastfeeding education sessions without the grandmother's attendance. The participating mothers answered questions from the Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF) at the time of the hospital discharge, and 4 and 8 weeks after delivery. Questions about the infants' feeding patterns were asked by telephone contact with the participating mothers from both groups at the same time periods.
RESULTS


The mean BFSE scores were signficantly different between the groups with grandmothers and without grandmothers at the time of the hospital discharge (60.15 ± 4.47 vs. 56.84 ± 6.22, independent t-test; p = 0.017), and at 4 weeks (61.71 ± 2.66 vs. 56.62 ± 9.12, p = 0.004) and 8 weeks after delivery (63.68 ± 2.14 vs. 60.03 ± 6.32, p = 0.003). No significant difference existed in infant feeding patterns between the groups at the same time periods.
CONCLUSIONS


This study suggests that breastfeeding education with grandmothers' attendance is effective in improving the mothers' breastfeeding self-efficacy. A family-centered program should be considered in beastfeeding education for increasing of exclusive breastfeeding.",2020,"The mean BFSE scores were signficantly different between the groups with grandmothers and without grandmothers at the time of the hospital discharge (60.15 ± 4.47 vs. 56.84 ± 6.22, independent t-test; p = 0.017), and at 4 weeks (61.71 ± 2.66 vs. 56.62 ± 9.12, p = 0.004) and 8 weeks after delivery (63.68 ± 2.14 vs. 60.03 ± 6.32, p = 0.003).","['Eligible pregnant women', '64 primiparous women who referred to the Antenatal Clinic of Amiralmomenin Hospital, Tehran, Iran from June to December, 2018', 'Iranian primiparous women', 'primiparous women, with and without the attendance of maternal grandmothers, on breastfeeding self-efficacy and infant feeding patterns', 'All eligible women seen in the clinic during 1 week were assigned to one group and women who presented in the alternating week were assigned to the other group']","[""breastfeeding education with grandmothers' attendance"", 'breastfeeding education sessions']","['infant feeding patterns', 'mean BFSE scores', 'Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0033150', 'cui_str': 'Para 1'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C1274027', 'cui_str': 'Antenatal clinic'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C1273525', 'cui_str': 'Maternal grandmother'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1286340', 'cui_str': 'Infant feeding pattern'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}]","[{'cui': 'C0418914', 'cui_str': 'Breastfeeding education'}, {'cui': 'C0337474', 'cui_str': 'Grandmother'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}]","[{'cui': 'C1286340', 'cui_str': 'Infant feeding pattern'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}]",64.0,0.0233771,"The mean BFSE scores were signficantly different between the groups with grandmothers and without grandmothers at the time of the hospital discharge (60.15 ± 4.47 vs. 56.84 ± 6.22, independent t-test; p = 0.017), and at 4 weeks (61.71 ± 2.66 vs. 56.62 ± 9.12, p = 0.004) and 8 weeks after delivery (63.68 ± 2.14 vs. 60.03 ± 6.32, p = 0.003).","[{'ForeName': 'Tayebeh', 'Initials': 'T', 'LastName': 'Gharaei', 'Affiliation': 'Department of Reproductive Health and Midwifery, Nursing Care Research Center, School of Nursing and Midwifery, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Amiri-Farahani', 'Affiliation': 'Department of Reproductive Health and Midwifery, Nursing Care Research Center, School of Nursing and Midwifery, Iran University of Medical Sciences, Tehran, Iran. amirifarahani.l@iums.ac.ir.'}, {'ForeName': 'Shima', 'Initials': 'S', 'LastName': 'Haghani', 'Affiliation': 'Department of Biostatistics, Nursing Care Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Syedeh Batool', 'Initials': 'SB', 'LastName': 'Hasanpoor-Azghady', 'Affiliation': 'Department of Reproductive Health and Midwifery, Nursing Care Research Center, School of Nursing and Midwifery, Iran University of Medical Sciences, Tehran, Iran.'}]",International breastfeeding journal,['10.1186/s13006-020-00325-5']
3250,33046128,The prophylactic and therapeutic effects of moxibustion combined with traditional Chinese medicine decoction for treating chemotherapy-induced myelosuppression in early-stage breast cancer: study protocol for a randomized controlled trial.,"BACKGROUND


Traditional Chinese medicine (TCM) has a long history of use in breast cancer, but lacking systematic evidence to support its clinical benefits. In this study, we evaluated the prophylactic and therapeutic effects of moxibustion combined with decoctions for treating chemotherapy-induced myelosuppression (CIM) in early-stage breast cancer patients.
METHODS


This is a randomized controlled clinical trial single-blinded for TCM decoction but not moxibustion. Patients are equally divided into the control group without decoction and moxibustion treatment (control), the decoction+moxibustion group (MD), and the placebo+moxibustion group (MP), according to the following stratification factors: age (below 40s, 40s, 50s, and 60s or above), chemotherapy regimen (anthracyclines, taxanes, anthracyclines+taxane, and others), and chemotherapy strategy (adjuvant and neoadjuvant). The TCM decoction is Wenshen Shengbai Decoction. The anticipated sample size is 462 cases (154 cases in each group). All participants are expected to treat with chemotherapy and recombinant human granulocyte colony-stimulating factor (rhG-CSF). The primary outcomes include the proportion of patients with relief of leukopenia and/or neutropenia, the myelosuppression-associated serious adverse event including grade 3-4 leukopenia and/or neutropenia, and febrile neutropenia, and the dose of rhG-CSF. The secondary outcomes include chemotherapy adherence, stratified analysis, adverse reactions, quality of life by EORTC Breast-Cancer-Specific Quality of Life Questionnaire including EORTC QLQ-C30 (V3.0) and QLQ-BR23, TCM Constitution, and 3-year disease-free survival and overall survival. Baseline information including age, surgical approach, chemotherapy regimen and strategy, pathological stage, and molecular subtype will be recorded.
DISCUSSION


This will be the first randomized controlled trial to evaluate the efficacy of moxibustion combined with TCM decoction in treating CIM in early-stage breast cancer patients, aiming to standardize the TCM decoction and moxibustion method, thus providing evidence for its clinical benefit.
TRIAL REGISTRATION


chictr.org.cn ChiCTR-INR-16009557 . Registered on 23 October 2016.",2020,"This will be the first randomized controlled trial to evaluate the efficacy of moxibustion combined with TCM decoction in treating CIM in early-stage breast cancer patients, aiming to standardize the TCM decoction and moxibustion method, thus providing evidence for its clinical benefit.
","['early-stage breast cancer', 'early-stage breast cancer patients']","['moxibustion combined with traditional Chinese medicine decoction', 'Traditional Chinese medicine (TCM', 'chemotherapy regimen (anthracyclines, taxanes, anthracyclines+taxane, and others), and chemotherapy strategy (adjuvant and neoadjuvant', 'moxibustion combined with decoctions', 'TCM decoction', 'control group without decoction and moxibustion treatment (control), the decoction+moxibustion group (MD), and the placebo+moxibustion group (MP', 'chemotherapy and recombinant human granulocyte colony-stimulating factor (rhG-CSF', 'moxibustion combined with TCM decoction']","['myelosuppression (CIM', 'chemotherapy adherence, stratified analysis, adverse reactions, quality of life by EORTC Breast-Cancer-Specific Quality of Life Questionnaire including EORTC QLQ-C30 (V3.0) and QLQ-BR23, TCM Constitution, and 3-year disease-free survival and overall survival', 'proportion of patients with relief of leukopenia and/or neutropenia, the myelosuppression-associated serious adverse event including grade 3-4 leukopenia and/or neutropenia, and febrile neutropenia, and the dose of rhG-CSF']","[{'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0026652', 'cui_str': 'Moxibustion'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0392920', 'cui_str': 'Antineoplastic chemotherapy regimen'}, {'cui': 'C0003234', 'cui_str': 'Anthracycline'}, {'cui': 'C0215136', 'cui_str': 'taxane'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1271481', 'cui_str': 'Recombinant human granulocyte colony stimulating factor'}]","[{'cui': 'C0854467', 'cui_str': 'Myelosuppression'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0009807', 'cui_str': 'Constitution'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0023530', 'cui_str': 'Leukopenia'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1271481', 'cui_str': 'Recombinant human granulocyte colony stimulating factor'}]",,0.235249,"This will be the first randomized controlled trial to evaluate the efficacy of moxibustion combined with TCM decoction in treating CIM in early-stage breast cancer patients, aiming to standardize the TCM decoction and moxibustion method, thus providing evidence for its clinical benefit.
","[{'ForeName': 'Yajie', 'Initials': 'Y', 'LastName': 'Ji', 'Affiliation': 'Department of Breast Surgery, Yueyang Hospital of Integrated Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200437, China.'}, {'ForeName': 'Siyu', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Department of Breast Surgery, Yueyang Hospital of Integrated Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200437, China.'}, {'ForeName': 'Xinyue', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Breast Surgery, Yueyang Hospital of Integrated Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200437, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Breast Surgery, Yueyang Hospital of Integrated Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200437, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Lu', 'Affiliation': 'Department of Breast Surgery, Yueyang Hospital of Integrated Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200437, China.'}, {'ForeName': 'Qiong', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Breast Surgery, Yueyang Hospital of Integrated Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200437, China.'}, {'ForeName': 'Weili', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'Department of Breast Surgery, Yueyang Hospital of Integrated Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200437, China.'}, {'ForeName': 'Jiayu', 'Initials': 'J', 'LastName': 'Sheng', 'Affiliation': 'Department of Breast Surgery, Yueyang Hospital of Integrated Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200437, China.'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Jiang', 'Affiliation': 'Department of Breast Surgery, Yueyang Hospital of Integrated Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200437, China.'}, {'ForeName': 'Hongli', 'Initials': 'H', 'LastName': 'Liang', 'Affiliation': 'Department of Breast Surgery, Yueyang Hospital of Integrated Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200437, China.'}, {'ForeName': 'Shanyan', 'Initials': 'S', 'LastName': 'Sha', 'Affiliation': 'Department of Breast Surgery, Yueyang Hospital of Integrated Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200437, China.'}, {'ForeName': 'Mengting', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Department of Breast Surgery, Yueyang Hospital of Integrated Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200437, China.'}, {'ForeName': 'Zongxin', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Department of Breast Surgery, Yueyang Hospital of Integrated Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200437, China.'}, {'ForeName': 'Peiyi', 'Initials': 'P', 'LastName': 'Zheng', 'Affiliation': 'Department of Breast Surgery, Yueyang Hospital of Integrated Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200437, China.'}, {'ForeName': 'Minhong', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'Department of Breast Surgery, Yueyang Hospital of Integrated Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200437, China.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Feng', 'Affiliation': 'Department of Breast Surgery, Yueyang Hospital of Integrated Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200437, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Breast Surgery, Yueyang Hospital of Integrated Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200437, China.'}, {'ForeName': 'Huangan', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'Shanghai Research Institute of Acupuncture and Meridian, Shanghai University of Traditional Chinese Medicine, Shanghai, 200030, China.'}, {'ForeName': 'Huirong', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Shanghai Research Institute of Acupuncture and Meridian, Shanghai University of Traditional Chinese Medicine, Shanghai, 200030, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Shanghai Research Institute of Acupuncture and Meridian, Shanghai University of Traditional Chinese Medicine, Shanghai, 200030, China.'}, {'ForeName': 'Zhiguang', 'Initials': 'Z', 'LastName': 'Yin', 'Affiliation': 'Shanghai Research Institute of Acupuncture and Meridian, Shanghai University of Traditional Chinese Medicine, Shanghai, 200030, China.'}, {'ForeName': 'Xiaohong', 'Initials': 'X', 'LastName': 'Xue', 'Affiliation': 'Department of Breast Surgery, Yueyang Hospital of Integrated Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200437, China. 195641459@qq.com.'}]",Trials,['10.1186/s13063-020-04749-6']
3251,33047325,The Coping with and Caring for Infants with Special Needs intervention was associated with improved motor development in preterm infants.,"AIM


We compared the impact of standard infant physiotherapy and the family-centred programme, Coping with and Caring for Infants with Special Needs (COPCA), in infants born before 32 weeks without significant brain lesions.
METHODS


This randomised controlled trial was carried out in patients' homes and outpatient settings in Switzerland between January 2016 and October 2019. We used data from the national SwissNeoNet register and an assessment battery that included infant and family outcomes and video analyses of therapy sessions. The Infant Motor Profile was the primary outcome instrument.
RESULTS


The COPCA group comprised six boys and two girls with a median gestational age of 27 weeks (range 25-30), and the standard care group comprised seven boys and one girl with a median gestational age of 29.5 weeks (range 26-31). COPCA participants improved significantly more between baseline and 18 months in the IMP variation (9.0 percentage points, 95% confidence interval: 0.3-17.5) and performance (12.0 percentage points, 95% confidence interval: 4.1-20.6) domains than standard care participants. COPCA coaching was positively associated with IMP scores at 18 months, but some standard care actions were negatively associated.
CONCLUSION


COPCA was associated with better motor outcome in infants born before 32 weeks than standard infant physiotherapy.",2020,"COPCA participants improved significantly more between baseline and 18 months in the IMP variation (9.0 percentage points, 95% confidence interval 0.3-17.5) and performance (12.0 percentage points, 95% confidence interval 4.1-20.6) domains than standard care participants.","['preterm infants', 'Infants with Special Needs (COPCA), in infants born before 32 weeks without significant brain lesions', 'group comprised six boys and two girls with a median gestational age of 27 weeks (range 25-30) and the standard care group comprised seven boys and one girl with a median gestational age of 29.5 weeks (range 26-31', ""patients' homes and outpatient settings in Switzerland between January 2016 and October 2019""]","['COPCA coaching', 'COPCA', 'standard infant physiotherapy and the family-centred programme, Coping With and Caring']","['IMP scores', 'IMP variation']","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0221505', 'cui_str': 'Lesion of brain'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}]","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}]","[{'cui': 'C0021533', 'cui_str': 'Inosine monophosphate'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}]",,0.179955,"COPCA participants improved significantly more between baseline and 18 months in the IMP variation (9.0 percentage points, 95% confidence interval 0.3-17.5) and performance (12.0 percentage points, 95% confidence interval 4.1-20.6) domains than standard care participants.","[{'ForeName': 'Schirin', 'Initials': 'S', 'LastName': 'Akhbari Ziegler', 'Affiliation': 'School of Health Professions, Institute of Physiotherapy, Zurich University of Applied Sciences ZHAW, Winterthur, Switzerland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'von Rhein', 'Affiliation': 'Department of Pediatrics, Kantonsspital Winterthur, Winterthur, Switzerland.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Meichtry', 'Affiliation': 'School of Health Professions, Institute of Physiotherapy, Zurich University of Applied Sciences ZHAW, Winterthur, Switzerland.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Wirz', 'Affiliation': 'School of Health Professions, Institute of Physiotherapy, Zurich University of Applied Sciences ZHAW, Winterthur, Switzerland.'}, {'ForeName': 'Tjitske', 'Initials': 'T', 'LastName': 'Hielkema', 'Affiliation': 'Department of Pediatrics, Division of Developmental Neurology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Mijna', 'Initials': 'M', 'LastName': 'Hadders-Algra', 'Affiliation': 'Department of Rehabilitation Medicine, Center for Rehabilitation, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Acta paediatrica (Oslo, Norway : 1992)",['10.1111/apa.15619']
3252,33038408,Long-term Follow-Up of Patients with Heart Failure and Reduced Ejection Fraction Receiving Autonomic Regulation Therapy in the ANTHEM-HF Pilot Study.,"BACKGROUND


The ANTHEM-HF pilot study was an open-label study that evaluated the safety and feasibility of autonomic regulation therapy (ART) utilizing cervical vagus nerve stimulation (VNS) for patients with chronic HF with reduced EF (HFrEF). Patients in NYHA class II-III with EF ≤40% (n = 60) received ART for 6 months post-titration. ART was associated with sustained improvement in left ventricular (LV) function and HF symptoms at 6 and 12 months.
METHODS


Continuously cyclic VNS was maintained to determine longer-term safety and chronic effects of ART. Echocardiographic parameters and HF symptoms were assessed throughout a follow-up period of at least 42 months.
RESULTS


Between 12 and 42 months after initial titration, there were no device-related SAEs or malfunctions. There were 10 SAEs adjudicated to be unrelated to VNS, including 5 deaths. There were 6 non-serious adverse events that were adjudicated to be device-related (2 oropharyngeal pain, 1 implant site pain, 2 voice alteration, and 1 hoarseness). At 42 months, there was significant improvement from baseline in LVEF, NYHA class, 6-min walk distance, and MLHFQ score. However, these improvements at 42 months were not significantly different from mean values at 6 and 12 months.
CONCLUSIONS


In a 42-month follow-up, ART was durable, safe, and was associated with beneficial effects on LVEF and 6-min walk distance. Long term, chronic, open-loop ART continued to be well-tolerated in patients with HFrEF. The open label, randomized, controlled, ANTHEM-HFrEF Pivotal Study is currently underway to further evaluate ART in patients with advanced HF.",2020,"At 42 months, there was significant improvement from baseline in LVEF, NYHA class, 6-min walk distance, and MLHFQ score.","['patients with advanced HF', 'patients with chronic HF with reduced EF (HFrEF', 'patients with heart failure and reduced ejection receiving', 'patients with HFrEF']","['autonomic regulation therapy', 'autonomic regulation therapy (ART) utilizing cervical vagus nerve stimulation (VNS']","['Echocardiographic parameters and HF symptoms', 'left ventricular (LV) function and HF symptoms', 'device-related SAEs or malfunctions', 'LVEF, NYHA class, 6-min walk distance, and MLHFQ score', 'LVEF and 6-min walk distance']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0336969', 'cui_str': 'Ejection'}]","[{'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C1275491', 'cui_str': 'New York Heart Association Classification'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0426096,"At 42 months, there was significant improvement from baseline in LVEF, NYHA class, 6-min walk distance, and MLHFQ score.","[{'ForeName': 'Kamal', 'Initials': 'K', 'LastName': 'Sharma', 'Affiliation': 'Sanjivani Super Specialty Hospitals, Ahmedabad, India.'}, {'ForeName': 'Rajendra K', 'Initials': 'RK', 'LastName': 'Premchand', 'Affiliation': 'Krishna Institute of Medical Sciences, Secunderabad, India.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Mittal', 'Affiliation': 'Medanta, The Medicity, Haryana, India.'}, {'ForeName': 'Rufino', 'Initials': 'R', 'LastName': 'Monteiro', 'Affiliation': 'Vintage Hospital, Goa, India.'}, {'ForeName': 'Imad', 'Initials': 'I', 'LastName': 'Libbus', 'Affiliation': 'LivaNova PLC, Inc., Houston, TX, United States of America.'}, {'ForeName': 'Lorenzo A', 'Initials': 'LA', 'LastName': 'DiCarlo', 'Affiliation': 'BioDev LLC, San Francisco, CA, United States of America.'}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Ardell', 'Affiliation': 'University of California at Los Angeles, Los Angeles, CA, United States of America.'}, {'ForeName': 'Badri', 'Initials': 'B', 'LastName': 'Amurthur', 'Affiliation': 'LivaNova PLC, Inc., Houston, TX, United States of America.'}, {'ForeName': 'Bruce H', 'Initials': 'BH', 'LastName': 'KenKnight', 'Affiliation': 'LivaNova PLC, Inc., Houston, TX, United States of America.'}, {'ForeName': 'Inder S', 'Initials': 'IS', 'LastName': 'Anand', 'Affiliation': 'University of Minnesota, Minneapolis, MN, United States of America. Electronic address: anand001@umn.edu.'}]",International journal of cardiology,['10.1016/j.ijcard.2020.09.072']
3253,33038438,Mechanical versus manual chest compressions in the treatment of in-hospital cardiac arrest patients in a non-shockable rhythm: A multi-centre feasibility randomised controlled trial (COMPRESS-RCT).,"BACKGROUND


Mechanical chest compression devices deliver high-quality chest compressions. Early data suggests that mechanical devices may be superior to manual chest compressions in adults following an in-hospital cardiac arrest patients. To determine the feasibility of undertaking an effectiveness trial in this population, we undertook a feasibility randomised controlled trial.
METHODS


We undertook a multi-centre parallel group feasibility randomised controlled trial (COMPRESS-RCT). Adult in-hospital cardiac arrest patients that were in a non-shockable rhythm were randomised in a 3:1 ratio to receive mechanical CPR (Jolfe AB/Stryker, Lund, Sweden) or ongoing manual CPR. Recruitment was led by the clinical cardiac arrest team. The primary study outcome was the proportion of eligible participants randomised in the study during site operational recruitment hours. Patients were enrolled under a model of deferred consent. We report data using descriptive statistics, point estimates and 95% confidence intervals.
RESULTS


Over a two-year period, we recruited 127 patients across five UK hospitals. We recruited 55.2% (95% CI 48.5%-61.8%) of eligible study participants in site operational recruitment hours. Most participants were male (n = 76, 59.8%) with a mean age of 72 (95% CI: 69.9-74.9) years. Median arrest duration was 18 (IQR 13-29) minutes. In patients randomised to mech-CPR, median time from CPR start to device deployment was 11 (IQR 7-15) minutes. ROSC was achieved in 27.6% (n = 35) participants and 4.7% (n = 6) were alive at 30-days.
CONCLUSION


COMPRESS-RCT identified important factors that preclude progression to an effectiveness trial of mechanical CPR in the hospital setting in the UK. Findings will inform the design of future in-hospital intra-arrest intervention trials. ISRCTN38139840, date of registration 9th January 2017.",2020,Early data suggests that mechanical devices may be superior to manual chest compressions in adults following an in-hospital cardiac arrest patients.,"['Most participants were male (n\u2009=\u200976, 59.8%) with a mean age of 72 (95% CI: 69.9 - 74.9) years', 'adults following an in-hospital cardiac arrest patients', 'hospital cardiac arrest patients in a non-shockable rhythm', 'Patients were enrolled under a model of deferred consent', 'Adult in-hospital cardiac arrest patients that were in a non-shockable rhythm', '127 patients across five UK hospitals']","['Mechanical versus manual chest compressions', 'mechanical CPR']","['ROSC', 'Median arrest duration']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C2711213', 'cui_str': 'Consented'}]","[{'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]",35.0,0.363067,Early data suggests that mechanical devices may be superior to manual chest compressions in adults following an in-hospital cardiac arrest patients.,"[{'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Couper', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK; University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK. Electronic address: k.couper@warwick.ac.uk.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Quinn', 'Affiliation': ""Emergency, Cardiovascular and Critical Care Research Group, Faculty of Health, Social Care and Education, Kingston University, London and St George's, University of London, London, UK.""}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Booth', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Ranjit', 'Initials': 'R', 'LastName': 'Lall', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Devrell', 'Affiliation': 'Patient Research Ambassador.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Orriss', 'Affiliation': 'Patient Research Ambassador.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Regan', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Yeung', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK; University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Gavin D', 'Initials': 'GD', 'LastName': 'Perkins', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK; University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}]",Resuscitation,['10.1016/j.resuscitation.2020.09.033']
3254,33038500,A pharmacist intervention for monitoring and treating hypertension using bidirectional texting: PharmText BP.,"BACKGROUND


New approaches are needed to better monitor blood pressure (BP) between physician visits, especially for patients in rural areas or for those who lack transportation. We have developed a custom-built bi-directional texting platform for home BP measurements that can then be managed by clinical pharmacists located remotely. The purpose of this study is to evaluate whether the BP texting approach combined with a pharmacist-based intervention improves BP management and to determine if the approach is cost effective.
METHODS


This study is a randomized, prospective trial in four primary care offices that serve patients in rural areas. Subjects will receive standardized research BP measurements at baseline, 6 and 12 months. The primary outcome will be differences between the intervention and control group in mean systolic BP at 12 months. Secondary outcomes will include systolic BP at 6 months; diastolic BP at 6 and 12 months, number of medication changes and costs.
CONCLUSIONS


This study plans to enroll subjects through 2022, follow-up will be completed in 2023 and results will be available in 2024. This study will provide information on whether a combined approach using texting of home BP values and a pharmacist-based telehealth services can improve BP control.",2020,"BACKGROUND


New approaches are needed to better monitor blood pressure (BP) between physician visits, especially for patients in rural areas or for those who lack transportation.","['patients in rural areas or for those who lack transportation', 'four primary care offices that serve patients in rural areas']",['pharmacist-based intervention'],"['systolic BP at 6\u202fmonths; diastolic BP at 6 and 12\u202fmonths, number of medication changes and costs', 'blood pressure (BP', 'mean systolic BP', 'BP management']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0332268', 'cui_str': 'Lacking'}, {'cui': 'C0040756', 'cui_str': 'Transportation'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0442603', 'cui_str': 'Office'}]","[{'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0580105', 'cui_str': 'Change of medication'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1272452', 'cui_str': 'Blood pressure taking management'}]",4.0,0.0842913,"BACKGROUND


New approaches are needed to better monitor blood pressure (BP) between physician visits, especially for patients in rural areas or for those who lack transportation.","[{'ForeName': 'Linnea A', 'Initials': 'LA', 'LastName': 'Polgreen', 'Affiliation': 'Department of Pharmacy Practice and Science, College of Pharmacy, University of Iowa, USA. Electronic address: linnea-polgreen@uiowa.edu.'}, {'ForeName': 'Barry L', 'Initials': 'BL', 'LastName': 'Carter', 'Affiliation': 'Department of Pharmacy Practice and Science, College of Pharmacy, University of Iowa, USA; Department of Family Medicine, Roy J. and Lucille A. Carver College of Medicine, University of Iowa, USA.'}, {'ForeName': 'Philip M', 'Initials': 'PM', 'LastName': 'Polgreen', 'Affiliation': 'Department of Internal Medicine, College of Medicine, University of Iowa, USA; Department of Epidemiology, College of Public Health, University of Iowa, USA.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Snyder', 'Affiliation': 'Department of Internal Medicine, College of Medicine, University of Iowa, USA.'}, {'ForeName': 'Daniel K', 'Initials': 'DK', 'LastName': 'Sewell', 'Affiliation': 'Department of Biostatistics, College of Public Health, University of Iowa, USA.'}, {'ForeName': 'Emine O', 'Initials': 'EO', 'LastName': 'Bayman', 'Affiliation': 'Department of Biostatistics, College of Public Health, University of Iowa, USA; Department of Anesthesia, College of Medicine, University of Iowa, USA.'}, {'ForeName': 'Shelby L', 'Initials': 'SL', 'LastName': 'Francis', 'Affiliation': 'Department of Internal Medicine, College of Medicine, University of Iowa, USA.'}, {'ForeName': 'Jacob E', 'Initials': 'JE', 'LastName': 'Simmering', 'Affiliation': 'Department of Internal Medicine, College of Medicine, University of Iowa, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Parker', 'Affiliation': 'Department of Pharmacy Practice and Science, College of Pharmacy, University of Iowa, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Finkelstein', 'Affiliation': 'Department of Pharmacy Practice and Science, College of Pharmacy, University of Iowa, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106169']
3255,33038501,Protocol of a randomized trial of acceptance and commitment therapy for fatigue interference in metastatic breast cancer.,"Fatigue interference with activities, mood, and cognition is one of the most prevalent and distressing concerns of metastatic breast cancer patients. To date, there are no evidence-based interventions for reducing fatigue interference in metastatic breast cancer and other advanced cancer populations. In pilot studies, Acceptance and Commitment Therapy (ACT) has shown potential for reducing symptom-related suffering in cancer patients. The current Phase II trial seeks to more definitively examine the efficacy of telephone-based ACT for women with metastatic breast cancer who are experiencing fatigue interference. In this trial, 250 women are randomly assigned to either the ACT intervention or an education/support control condition. Women in both conditions attend six weekly 50-min telephone sessions. The primary aim of this study is to test the effect of telephone-based ACT on fatigue interference. Secondary outcomes include sleep interference, engagement in daily activities, and quality of life. Outcomes are assessed at baseline, 2 weeks post-intervention, and 3 and 6 months post-intervention. This trial also examines whether increases in psychological flexibility, defined as full awareness of the present moment while persisting in behaviors aligned with personal values, account for the beneficial effect of ACT on fatigue interference. After demonstrating ACT's efficacy, the intervention can be widely disseminated to clinicians who care for metastatic breast cancer patients. Our findings will also inform future ACT trials with various cancer populations and functional outcomes.",2020,"In pilot studies, Acceptance and Commitment Therapy (ACT) has shown potential for reducing symptom-related suffering in cancer patients.","['250 women', 'women with metastatic breast cancer who are experiencing fatigue interference', 'metastatic breast cancer', 'cancer patients', 'metastatic breast cancer patients', 'metastatic breast cancer and other advanced cancer populations']","['telephone-based ACT', 'Acceptance and Commitment Therapy (ACT', 'acceptance and commitment therapy', 'ACT intervention or an education/support control condition']","['sleep interference, engagement in daily activities, and quality of life', 'psychological flexibility', 'Fatigue interference with activities, mood, and cognition', 'fatigue interference']","[{'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0029917', 'cui_str': 'Outpatient Commitment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3658321', 'cui_str': 'Acceptance and commitment therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",250.0,0.0784595,"In pilot studies, Acceptance and Commitment Therapy (ACT) has shown potential for reducing symptom-related suffering in cancer patients.","[{'ForeName': 'Catherine E', 'Initials': 'CE', 'LastName': 'Mosher', 'Affiliation': 'Department of Psychology, Indiana University-Purdue University Indianapolis, 402 North Blackford Street, LD 124, Indianapolis, IN 46202, USA. Electronic address: cemosher@iupui.edu.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Krueger', 'Affiliation': 'Department of Psychology, Indiana University-Purdue University Indianapolis, 402 North Blackford Street, LD 124, Indianapolis, IN 46202, USA. Electronic address: efkruege@iu.edu.'}, {'ForeName': 'Adam T', 'Initials': 'AT', 'LastName': 'Hirsh', 'Affiliation': 'Department of Psychology, Indiana University-Purdue University Indianapolis, 402 North Blackford Street, LD 124, Indianapolis, IN 46202, USA. Electronic address: athirsh@iupui.edu.'}, {'ForeName': 'Kathy D', 'Initials': 'KD', 'LastName': 'Miller', 'Affiliation': 'Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indiana Cancer Pavilion, 535 Barnhill Drive, Suite 473, Indianapolis, IN 46202, USA. Electronic address: kathmill@iu.edu.'}, {'ForeName': 'Tarah J', 'Initials': 'TJ', 'LastName': 'Ballinger', 'Affiliation': 'Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indiana Cancer Pavilion, 535 Barnhill Drive, Suite 473, Indianapolis, IN 46202, USA. Electronic address: tarahb@iu.edu.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Storniolo', 'Affiliation': 'Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indiana Cancer Pavilion, 535 Barnhill Drive, Suite 473, Indianapolis, IN 46202, USA. Electronic address: astornio@iu.edu.'}, {'ForeName': 'Bryan P', 'Initials': 'BP', 'LastName': 'Schneider', 'Affiliation': 'Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indiana Cancer Pavilion, 535 Barnhill Drive, Suite 473, Indianapolis, IN 46202, USA. Electronic address: bpschnei@iu.edu.'}, {'ForeName': 'Erin V', 'Initials': 'EV', 'LastName': 'Newton', 'Affiliation': 'Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indiana Cancer Pavilion, 535 Barnhill Drive, Suite 473, Indianapolis, IN 46202, USA. Electronic address: evnewton@iu.edu.'}, {'ForeName': 'Victoria L', 'Initials': 'VL', 'LastName': 'Champion', 'Affiliation': 'Indiana University School of Nursing, 1111 Middle Drive, NU 340G, Indianapolis, IN 46202, USA. Electronic address: vchampio@iu.edu.'}, {'ForeName': 'Shelley A', 'Initials': 'SA', 'LastName': 'Johns', 'Affiliation': 'Indiana University School of Medicine, Center for Health Services Research, Regenstrief Institute, 1101 W. 10(th) Street, Indianapolis, IN 46202, USA. Electronic address: sheljohn@iu.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106168']
3256,33038677,Rethink Vape: Development and evaluation of a risk communication campaign to prevent youth E-cigarette use.,"INTRODUCTION


E-cigarettes are now the most common form of tobacco use among adolescents, and use is associated with increased risk of initiation of cigarette smoking. This project used a community-engaged research process to develop and pilot a risk communication campaign to prevent youth vaping.
METHOD


The research team worked with a 36-member Teen Advisory Council and a 19-member Expert Panel. Together, the team employed survey (N = 674) and focus group (N = 82) methodologies, and hired a marketing company to partner on development of the campaign. Campaign concepts were developed, eliminated, and/or modified through an iterative process of feedback and refinement. The final campaign included video ads (https://bit.ly/2QMR8gH) a microsite (rethinkvape.org), and social media sites (@rethinkvape). The campaign communicated three messages to teens: what's in the vapor, health risks, and connections to big tobacco. Prior to launch of the campaign, a randomized controlled 2 (time) × 2 (group) online experiment was conducted to evaluate the campaign (N = 268).
RESULTS


Repeated measures mixed analyses of variance indicated that vaping knowledge, perceptions of risk, and anti-vape intentions significantly increased among teens viewing the Rethink Vape Materials compared to their own baseline, while control participants did not change. Following evaluation, the team launched a 6-week online media campaign with a teen-targeted geo-fence radius to deliver 3,838,465 impressions, 770,443 completed video views, and 18,316 clicks in mobile app, Snapchat, YouTube, and Spotify platforms. The majority of placements exceeded industry standards, with mobile pre-roll and Snapchat as top performers.
CONCLUSIONS


The e-cigarette campaign showed promising signs of effectiveness and scalability.",2020,"RESULTS


Repeated measures mixed analyses of variance indicated that vaping knowledge, perceptions of risk, and anti-vape intentions significantly increased among teens viewing the Rethink Vape Materials compared to their own baseline, while control participants did not change.",[],['Rethink Vape'],"['vaping knowledge, perceptions of risk, and anti-vape intentions', 'video ads (https://bit.ly/2QMR8gH) a microsite (rethinkvape.org), and social media sites (@rethinkvape']",[],"[{'cui': 'C0291011', 'cui_str': 'VAPE protocol'}]","[{'cui': 'C0052148', 'cui_str': 'APEL protocol'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0291011', 'cui_str': 'VAPE protocol'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0205145', 'cui_str': 'Site'}]",770443.0,0.0316952,"RESULTS


Repeated measures mixed analyses of variance indicated that vaping knowledge, perceptions of risk, and anti-vape intentions significantly increased among teens viewing the Rethink Vape Materials compared to their own baseline, while control participants did not change.","[{'ForeName': 'K J', 'Initials': 'KJ', 'LastName': 'England', 'Affiliation': 'Pediatrics Division of Community Health and Research, Eastern Virginia Medical School, PO Box 1980, Norfolk, VA 23501, United States. Electronic address: englankj@evms.edu.'}, {'ForeName': 'A L', 'Initials': 'AL', 'LastName': 'Edwards', 'Affiliation': 'Pediatrics Division of Community Health and Research, Eastern Virginia Medical School, PO Box 1980, Norfolk, VA 23501, United States.'}, {'ForeName': 'A C', 'Initials': 'AC', 'LastName': 'Paulson', 'Affiliation': 'Pediatrics Division of Community Health and Research, Eastern Virginia Medical School, PO Box 1980, Norfolk, VA 23501, United States.'}, {'ForeName': 'E P', 'Initials': 'EP', 'LastName': 'Libby', 'Affiliation': 'Pediatrics Division of Community Health and Research, Eastern Virginia Medical School, PO Box 1980, Norfolk, VA 23501, United States.'}, {'ForeName': 'P T', 'Initials': 'PT', 'LastName': 'Harrell', 'Affiliation': 'Pediatrics Division of Community Health and Research, Eastern Virginia Medical School, PO Box 1980, Norfolk, VA 23501, United States.'}, {'ForeName': 'K A', 'Initials': 'KA', 'LastName': 'Mondejar', 'Affiliation': 'Pediatrics Division of Community Health and Research, Eastern Virginia Medical School, PO Box 1980, Norfolk, VA 23501, United States.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106664']
3257,33038685,Intrinsic foot muscle strengthening exercises with electromyographic biofeedback achieve increased toe flexor strength in older adults: A pilot randomized controlled trial.,"BACKGROUND


Toe flexor strength is important for preventing older adults from falling. Although intrinsic foot muscles are the main determinants of toe flexor strength, exercises for strengthening these muscles are difficult for older adults. This study therefore aimed to determine whether the use of electromyographic biofeedback helps older adults to perform intrinsic foot muscle strengthening exercises.
METHODS


This randomized controlled trial had two parallel arms. Participants were randomly allocated to the control group or the electromyographic biofeedback group. Control participants performed two progressive intrinsic foot muscle strengthening exercises twice a week for 6 weeks. Participants in the other group performed these exercises assisted by electromyographic biofeedback. Primary outcome measures were changes in toe flexor strength and the timed up-and-go and functional reach tests (the latter two being balance tests).
FINDINGS


Altogether, 23 older adults were randomized to the control group (n = 12) or the electromyographic biofeedback group (n = 11). After the 6-week intervention, toe flexor strength on the dominant side increased in both groups (P < 0.017). However, toe flexor strength on the nondominant side increased only in the electromyographic biofeedback group (P < 0.017), with a large effect size of 1.5. There were no changes in the two balance tests. Three of the control group and two of the electromyographic biofeedback group were lost to follow- up.
INTERPRETATION


Our results indicate that, the use of electromyographic biofeedback can enhance the effect of intrinsic foot muscle strengthening exercises on the nondominant side in older adults.
CLINICAL TRIAL REGISTRATION NUMBER


UMIN000036521.",2020,"However, toe flexor strength on the nondominant side increased only in the electromyographic biofeedback group (P < 0.017), with a large effect size of 1.5.","['older adults', 'older adults from falling', '23 older adults']","['electromyographic biofeedback', 'exercises assisted by electromyographic biofeedback', 'progressive intrinsic foot muscle strengthening exercises', 'Intrinsic foot muscle strengthening exercises with electromyographic biofeedback', 'electromyographic biofeedback group']","['toe flexor strength on the nondominant side', 'toe flexor strength', 'changes in toe flexor strength and the timed up-and-go and functional reach tests (the latter two being balance tests']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}]","[{'cui': 'C0204624', 'cui_str': 'Electromyographic biofeedback'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0581753', 'cui_str': 'Muscle structure of foot'}, {'cui': 'C0452260', 'cui_str': 'Muscular strength development exercise'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0040357', 'cui_str': 'Toe structure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C1998271', 'cui_str': 'Functional reach test'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",23.0,0.0409907,"However, toe flexor strength on the nondominant side increased only in the electromyographic biofeedback group (P < 0.017), with a large effect size of 1.5.","[{'ForeName': 'Kazunori', 'Initials': 'K', 'LastName': 'Okamura', 'Affiliation': 'Department of Physical Therapy, Faculty of Health and Welfare, Prefectural University of Hiroshima, 1-1 Gakuen-cho, Mihara, Hiroshima 723-0053, Japan. Electronic address: k-okamura@pu-hiroshima.ac.jp.'}, {'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Egawa', 'Affiliation': 'Graduate School of Comprehensive Scientific Research, Prefectural University of Hiroshima, 1-1 Gakuen-cho, Mihara, Hiroshima 723-0053, Japan; Okii Clinic, 4-5-10 Motomachi, Iwakuni, Yamaguchi 740-0012, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Okii', 'Affiliation': 'Okii Clinic, 4-5-10 Motomachi, Iwakuni, Yamaguchi 740-0012, Japan.'}, {'ForeName': 'Sadaaki', 'Initials': 'S', 'LastName': 'Oki', 'Affiliation': 'Department of Physical Therapy, Faculty of Health and Welfare, Prefectural University of Hiroshima, 1-1 Gakuen-cho, Mihara, Hiroshima 723-0053, Japan. Electronic address: oki@pu-hiroshima.ac.jp.'}, {'ForeName': 'Shusaku', 'Initials': 'S', 'LastName': 'Kanai', 'Affiliation': 'Department of Physical Therapy, Faculty of Health and Welfare, Prefectural University of Hiroshima, 1-1 Gakuen-cho, Mihara, Hiroshima 723-0053, Japan. Electronic address: kanai@pu-hiroshima.ac.jp.'}]","Clinical biomechanics (Bristol, Avon)",['10.1016/j.clinbiomech.2020.105187']
3258,33041263,Evaluation of beneficial effect of a dual-task exercise based on Japanese transitional games in older adults: a pilot study.,"Not only does Japan has the world's longest healthy life expectancy, but also the world's longest average life span. This study investigated the effect of a novel dual-task (DT) exercise called ""Synapsology"" (SYNAP), developed as a game-like activity to improve older adults' physical and cognitive functions. Participants (n=24) with a mean age of 70.6 years (65-77 years) were randomly assigned to the SYNAP exercise group (SG, n=15) and the control group (CG, n=9). The SG participated in the DT intervention consisting of 60-minute sessions, twice a week, for 8 weeks. Physical function in timed-up-and-go had significant pre- and post- trial differences (P=0.017) in SG. In addition, cognitive function results in the a 25-hole trail-making peg test (P=0.004) and an oxidative stress marker (P=0.039) had a statistically significant difference within the SG. However, there were no significant differences in the physical and cognitive functions between SG and CG. In the study, older adults who participated in cognitive-motor DT intervention improved significantly with regard to motor ability and cognitive function results. Thus, a game-like DT exercise may help maintain the healthy life of older adults compared to no intervention.",2020,Physical function in timed-up-and-go had significant pre- and post- trial differences (P=0.017) in SG.,"['older adults who participated in', 'Participants (n=24) with a mean age of 70.6 years (65-77 years', 'Japanese transitional games in older adults', 'older adults']","['dual-task exercise', 'SYNAP exercise', 'cognitive-motor DT intervention', 'novel dual-task (DT) exercise called ""Synapsology"" (SYNAP', 'game-like DT exercise']","['Physical function', 'oxidative stress marker', 'physical and cognitive functions', 'motor ability and cognitive function results']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C1720420', 'cui_str': 'Call'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]",,0.0163609,Physical function in timed-up-and-go had significant pre- and post- trial differences (P=0.017) in SG.,"[{'ForeName': 'Jieun', 'Initials': 'J', 'LastName': 'Yoon', 'Affiliation': 'R&D Center for Tailor-Made QOL, University of Tsukuba, Tsukuba, Ibaraki, Japan.'}, {'ForeName': 'Hiroko', 'Initials': 'H', 'LastName': 'Isoda', 'Affiliation': 'R&D Center for Tailor-Made QOL, University of Tsukuba, Tsukuba, Ibaraki, Japan.'}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Okura', 'Affiliation': 'R&D Center for Tailor-Made QOL, University of Tsukuba, Tsukuba, Ibaraki, Japan.'}]",Aging,['10.18632/aging.103908']
3259,33043883,DMT alters cortical travelling waves.,"Psychedelic drugs are potent modulators of conscious states and therefore powerful tools for investigating their neurobiology. N,N, Dimethyltryptamine (DMT) can rapidly induce an extremely immersive state of consciousness characterized by vivid and elaborate visual imagery. Here, we investigated the electrophysiological correlates of the DMT-induced altered state from a pool of participants receiving DMT and (separately) placebo (saline) while instructed to keep their eyes closed. Consistent with our hypotheses, results revealed a spatio-temporal pattern of cortical activation (i.e. travelling waves) similar to that elicited by visual stimulation. Moreover, the typical top-down alpha-band rhythms of closed-eyes rest were significantly decreased, while the bottom-up forward wave was significantly increased. These results support a recent model proposing that psychedelics reduce the 'precision-weighting of priors', thus altering the balance of top-down versus bottom-up information passing. The robust hypothesis-confirming nature of these findings imply the discovery of an important mechanistic principle underpinning psychedelic-induced altered states.",2020,"Here, we investigated the electrophysiological correlates of the DMT induced altered state from a pool of participants receiving DMT and (separately) placebo (saline) while instructed to keep their eyes closed.",[],"['placebo (saline', 'Dimethyltryptamine (DMT', 'DMT']",['typical top-down alpha-band rhythms of closed-eyes rest'],[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0337051', 'cui_str': 'Pool'}, {'cui': 'C0027183', 'cui_str': 'N,-N-dimethyltryptamine'}]","[{'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0035253', 'cui_str': 'Rest'}]",,0.0411564,"Here, we investigated the electrophysiological correlates of the DMT induced altered state from a pool of participants receiving DMT and (separately) placebo (saline) while instructed to keep their eyes closed.","[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Alamia', 'Affiliation': 'Cerco, CNRS Université de Toulouse, Toulouse, France.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Timmermann', 'Affiliation': 'Computational, Cognitive and Clinical Neuroscience Laboratory (C3NL), Faculty of Medicine, Imperial College, London, United Kingdom.'}, {'ForeName': 'Rufin', 'Initials': 'R', 'LastName': 'VanRullen', 'Affiliation': 'Cerco, CNRS Université de Toulouse, Toulouse, France.'}, {'ForeName': 'Robin L', 'Initials': 'RL', 'LastName': 'Carhart-Harris', 'Affiliation': 'Centre for Psychedelic Research, Division of Psychiatry, Department of Brain Sciences, Imperial College London, London, United Kingdom.'}]",eLife,['10.7554/eLife.59784']
3260,33039508,Using behavioural insights to reduce sugar in primary school children's packed lunches in derby; A cluster randomised controlled trial.,"Children's packed lunches contain more sugar than school-provided meals. Interventions to improve the provision of healthier packed lunches have modest effects on lunch contents. This cluster randomised controlled trial tested an intervention to encourage healthier provision of packed lunches by parents of primary school children in Derby. Schools were randomised to intervention (n = 8) or control (n = 9) using blocked random allocation. In the intervention group, parents of children who brought packed lunches to school in years 3-6 (age 7-11 years) received three bundles of materials (including packed lunch planner, shopping list, information on sugar content of popular lunchbox items and suggestions for healthier swap alternatives) in bookbags/lunchboxes over a 4-week period. Control parents received no materials. Photos of lunchbox contents were taken at baseline, immediately post-intervention and at three-month follow-up. A parental survey aimed to assess capability, opportunity and motivation for packing a healthier lunchbox. No intervention effects were observed for primary outcomes (presence and number of sugary snacks or chilled sugary desserts). The intervention had a significant impact on one secondary outcome (increased number of healthier ""swap"" items suggested in intervention materials) immediately post-intervention, but this effect had disappeared at three-month follow-up. No intervention effects were found on survey variables. Parent comments revealed that materials were either received positively (as they reinforced existing behaviours) or negatively (as they were not perceived to be helpful or appropriate). The results of this study suggest that providing educational materials and resources to parents of primary school children in Derby was not sufficient to increase provision of healthier packed lunches. Future research should investigate how behavioural science can support families to improve the nutritional content of primary school children's lunchboxes.",2020,This cluster randomised controlled trial tested an intervention to encourage healthier provision of packed lunches by parents of primary school children in Derby.,"['packed lunches by parents of primary school children in Derby', ""primary school children's packed lunches in Derby"", 'parents of children who brought packed lunches to school in years 3-6 (age 7-11 years) received', ""primary school children's lunchboxes""]","['three bundles of materials (including packed lunch planner, shopping list, information on sugar content of popular lunchbox items and suggestions for healthier swap alternatives) in bookbags/lunchboxes']","['number of healthier ""swap"" items', 'primary outcomes (presence and number of sugary snacks or chilled sugary desserts']","[{'cui': 'C0184967', 'cui_str': 'Insertion of pack'}, {'cui': 'C2697949', 'cui_str': 'Lunch'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332302', 'cui_str': 'Brought on by'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0442759', 'cui_str': '3/6'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0184967', 'cui_str': 'Insertion of pack'}, {'cui': 'C2697949', 'cui_str': 'Lunch'}, {'cui': 'C0150768', 'cui_str': 'Shopping'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0038659', 'cui_str': 'Suggestion'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C0085593', 'cui_str': 'Chill'}, {'cui': 'C0453505', 'cui_str': 'Dessert'}]",,0.0360658,This cluster randomised controlled trial tested an intervention to encourage healthier provision of packed lunches by parents of primary school children in Derby.,"[{'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Bunten', 'Affiliation': 'Public Health England Behavioural Insights, Wellington House, 133-155 Waterloo Road, London, SE1 8UG, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Porter', 'Affiliation': 'Public Health England Behavioural Insights, Wellington House, 133-155 Waterloo Road, London, SE1 8UG, UK. Electronic address: L.Porter@exeter.ac.uk.'}, {'ForeName': 'Jilla', 'Initials': 'J', 'LastName': 'Burgess-Allen', 'Affiliation': 'Derby City Council, Council House, Corporation Street, Derby, DE1 2FS, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Howell-Jones', 'Affiliation': 'Public Health England Behavioural Insights, Wellington House, 133-155 Waterloo Road, London, SE1 8UG, UK.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Jackson', 'Affiliation': 'University of Derby, Kedleston Road, Derby, DE22 1GB, UK.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Ward', 'Affiliation': 'Medical School, University of Lincoln, Brayford Way, Brayford Pool, Lincoln, LN6 7TS, UK; Public Health Division, Adult Care and Community Wellbeing, Lincolnshire County Council, County Offices, Newland, Lincoln, LN1 1YL, UK.'}, {'ForeName': 'Vicki', 'Initials': 'V', 'LastName': 'Staples', 'Affiliation': 'University of Derby, Kedleston Road, Derby, DE22 1GB, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Staples', 'Affiliation': 'University of Derby, Kedleston Road, Derby, DE22 1GB, UK.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'Rowthorn', 'Affiliation': 'Public Health England Behavioural Insights, Wellington House, 133-155 Waterloo Road, London, SE1 8UG, UK; Department of Psychology, University of Warwick, Coventry, CV4 7AL, UK.'}, {'ForeName': 'Ayoub', 'Initials': 'A', 'LastName': 'Saei', 'Affiliation': 'Public Health England, Wellington House, 133-155 Waterloo Road, London, SE1 8UG, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'van Schaik', 'Affiliation': 'School of Social Sciences and Law, Teesside University, Campus Heart, Southfield Rd, Middlesbrough, TS1 3BX, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Tydeman', 'Affiliation': 'Public Health England, Wellington House, 133-155 Waterloo Road, London, SE1 8UG, UK.'}, {'ForeName': 'Penny', 'Initials': 'P', 'LastName': 'Blair', 'Affiliation': 'Public Health England, Wellington House, 133-155 Waterloo Road, London, SE1 8UG, UK.'}, {'ForeName': 'Orla', 'Initials': 'O', 'LastName': 'Hugueniot', 'Affiliation': 'Public Health England, Wellington House, 133-155 Waterloo Road, London, SE1 8UG, UK.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Gold', 'Affiliation': 'Public Health England Behavioural Insights, Wellington House, 133-155 Waterloo Road, London, SE1 8UG, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Chadborn', 'Affiliation': 'Public Health England Behavioural Insights, Wellington House, 133-155 Waterloo Road, London, SE1 8UG, UK.'}]",Appetite,['10.1016/j.appet.2020.104987']
3261,33039992,"Multicentre, randomised, open-label, non-inferiority trial comparing the effectiveness and safety of ductal lavage versus oral corticosteroids for idiopathic granulomatous mastitis: a study protocol.","INTRODUCTION


The ideal treatment for idiopathic granulomatous mastitis (IGM) remains unclear. In a prospective, single-centre, pilot study, we reported that ductal lavage treatment for non-lactational mastitis patients had a 1-year clinical complete response (cCR) rate of >90%, without any significant adverse events. Thus, in this multicentre, randomised, open-label, non-inferiority trial, we will aim to compare the effectiveness and safety of ductal lavage vs oral corticosteroids as the first-line treatment for patients with IGM.
METHODS AND ANALYSIS


The trial will be conducted at the Breast Tumor Center of Sun Yat-sen Memorial Hospital in China and at least at one participating regional centre. We plan to recruit 140 eligible IGM patients who will be randomised into the ductal lavage group or oral corticosteroid group with a 1:1 ratio. The patients in the oral corticosteroid group will receive meprednisone or prednisone for 6 months. The patients in the ductal lavage group will receive ductal lavage and breast massage, as previously reported. All the participants will be followed up at the clinic for 1 year post randomisation. The primary endpoint of this trial will be the 1-year cCR rate, and the secondary endpoints will include the time to cCR, treatment failure rate, relapse rate and protocol compliance rate. The trial was designed to determine whether ductal lavage is non-inferior to oral corticosteroids (1-year cCR rate assumed to be 90%), with a non-inferiority margin of 15%.
ETHICS AND DISSEMINATION


The ethics committee of Sun Yat-sen Memorial Hospital at Sun Yat-sen University approved the study (2018-Lun-Shen-Yan-No. 30). The results of the trial will be communicated to the participating primary care practices, published in international journals and presented at international clinical and scientific conferences.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov Registry (NCT03724903); Pre-results.",2020,"The trial was designed to determine whether ductal lavage is non-inferior to oral corticosteroids (1-year cCR rate assumed to be 90%), with a non-inferiority margin of 15%.
","['140 eligible IGM patients who will be randomised into the', 'non-lactational mastitis patients', 'patients with IGM', 'Breast Tumor Center of Sun Yat-sen Memorial Hospital in China and at least at one participating regional centre', 'idiopathic granulomatous mastitis']","['meprednisone or prednisone', 'ductal lavage versus oral corticosteroids', 'ductal lavage group or oral corticosteroid', 'ductal lavage and breast massage', 'ductal lavage vs oral corticosteroids']","['time to cCR, treatment failure rate, relapse rate and protocol compliance rate', '1-year clinical complete response (cCR) rate', '1-year cCR rate']","[{'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C4552494', 'cui_str': 'Idiopathic granulomatous mastitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024894', 'cui_str': 'Mastitis'}, {'cui': 'C1458155', 'cui_str': 'Neoplasm of breast'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0038817', 'cui_str': 'Sunlight'}, {'cui': 'C0036644', 'cui_str': 'Senegal'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0558281', 'cui_str': 'Regional center'}]","[{'cui': 'C0065967', 'cui_str': 'meprednisone'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0024875', 'cui_str': 'Massage'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0525058', 'cui_str': 'Protocol Compliance'}, {'cui': 'C0439234', 'cui_str': 'year'}]",140.0,0.222058,"The trial was designed to determine whether ductal lavage is non-inferior to oral corticosteroids (1-year cCR rate assumed to be 90%), with a non-inferiority margin of 15%.
","[{'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Hu', 'Affiliation': 'Breast Tumor Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Shunrong', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Breast Tumor Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Heng', 'Initials': 'H', 'LastName': 'Huang', 'Affiliation': ""Department of Mammary Surgery, Lianjiang People's Hospital, Zhanjiang, Guangdong, China.""}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Huang', 'Affiliation': 'Department of Mammary Surgery, Maternity and Child Health Care Hospital of Jiangmen, Jiangmen, Guangdong, China.'}, {'ForeName': 'Luyuan', 'Initials': 'L', 'LastName': 'Tan', 'Affiliation': 'Breast Tumor Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Yanbo', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of orthopedics, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Heran', 'Initials': 'H', 'LastName': 'Deng', 'Affiliation': 'Breast Tumor Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Jiannan', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Breast Tumor Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Liling', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': 'Breast Tumor Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Fengxi', 'Initials': 'F', 'LastName': 'Su', 'Affiliation': 'Breast Tumor Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Chen', 'Affiliation': 'Breast Tumor Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China chenkai23@mail.sysu.edu.cn.'}]",BMJ open,['10.1136/bmjopen-2019-036643']
3262,33039994,Early Parenting Acceptance and Commitment Therapy 'Early PACT' for parents of infants with cerebral palsy: a study protocol of a randomised controlled trial.,"INTRODUCTION


New international clinical practice guidelines exist for identifying infants at high risk of cerebral palsy (CP) earlier: between 12 to 24 weeks corrected age, significantly earlier than previous diagnosis windows in Australia at 19 months. The earlier detection of infants at high risk of CP creates an opportunity for earlier intervention. The quality of the parent-infant relationship impacts various child outcomes, and is leveraged in other forms of intervention. This paper presents the protocol of a randomised controlled trial of an online parent support programme, Early Parenting Acceptance and Commitment Therapy (Early PACT) for families of infants identified as at high risk of CP. We predict that participating in the Early PACT programme will be associated with improvements in the parent-infant relationship, in parent mental health and well-being as well as infant behaviour and quality of life.
METHODS AND ANALYSIS


This study aims to recruit 60 parents of infants (0 to 2 years old corrected age) diagnosed with CP or identified as at high risk of having CP. Participants will be randomly allocated to one of two groups: Early PACT or waitlist control (1:1). Early PACT is an online parent support programme grounded in Acceptance and Commitment Therapy (ACT). It is delivered as a course on an open source course management system called edX. Early PACT is designed to support parental adjustment and parent-infant relationship around the time of early diagnosis. Assessments will be conducted at baseline, following completion of Early PACT and at 6-month follow-up (retention). The primary outcome will be the quality of parent-child interactions as measured by the Emotional Availability Scale. Standard analysis methods for randomised controlled trial will be used to make comparisons between the two groups (Early PACT and waitlist control). Retention of effects will be examined at 6-month follow-up.
ETHICS AND DISSEMINATION


This study is approved through appropriate Australian and New Zealand ethics committees (see in text) with parents providing written informed consent. Findings from this trial will be disseminated through peer-reviewed journal publications and conference presentations.
TRIAL REGISTRATION DETAILS


This trial has been prospectively registered on 12 June 2018 to present (ongoing) with the Australian New Zealand Clinical Trials Registry (ACTRN12618000986279); https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=3 74 896.",2020,"This paper presents the protocol of a randomised controlled trial of an online parent support programme, Early Parenting Acceptance and Commitment Therapy (Early PACT) for families of infants identified as at high risk of CP.","['60 parents of infants (0 to 2 years old corrected age) diagnosed with CP or identified as at high risk of having CP', 'families of infants identified as at high risk of CP', 'parents of infants with cerebral palsy', '12 June 2018 to present (ongoing) with the Australian New Zealand Clinical Trials Registry (ACTRN12618000986279); https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=3\u200974\u2009896']","['online parent support programme, Early Parenting Acceptance and Commitment Therapy (Early PACT', ""Early Parenting Acceptance and Commitment Therapy 'Early PACT"", 'Early PACT or waitlist control']",['quality of parent-child interactions as measured by the Emotional Availability Scale'],"[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0034975', 'cui_str': 'Registries'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C3658321', 'cui_str': 'Acceptance and commitment therapy'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.185074,"This paper presents the protocol of a randomised controlled trial of an online parent support programme, Early Parenting Acceptance and Commitment Therapy (Early PACT) for families of infants identified as at high risk of CP.","[{'ForeName': 'Koa', 'Initials': 'K', 'LastName': 'Whittingham', 'Affiliation': 'Queensland Cerebral Palsy and Rehabilitation Research Centre, UQ Child Health Research Centre (CHRC), Faculty of Medicine, The University of Queensland, Brisbane, Queensland, Australia koawhittingham@uq.edu.au.'}, {'ForeName': 'Jeanie', 'Initials': 'J', 'LastName': 'Sheffield', 'Affiliation': 'School of Psychology, The University of Queensland, Saint Lucia, Queensland, Australia.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Mak', 'Affiliation': 'Queensland Cerebral Palsy and Rehabilitation Research Centre, UQ Child Health Research Centre (CHRC), Faculty of Medicine, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Corrine', 'Initials': 'C', 'LastName': 'Dickinson', 'Affiliation': 'Queensland Cerebral Palsy and Rehabilitation Research Centre, UQ Child Health Research Centre (CHRC), Faculty of Medicine, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Roslyn N', 'Initials': 'RN', 'LastName': 'Boyd', 'Affiliation': 'Queensland Cerebral Palsy and Rehabilitation Research Centre, UQ Child Health Research Centre (CHRC), Faculty of Medicine, The University of Queensland, Brisbane, Queensland, Australia.'}]",BMJ open,['10.1136/bmjopen-2020-037033']
3263,33040002,"Rationale and design for Lowering-hyperUricaemia treatment on cardiovascular outcoMes In peritoNeal diAlysis patients: a prospective, multicentre, double-blind, randomised controlled trial (LUMINA).","INTRODUCTION


The prevalence of hyperuricaemia in peritoneal dialysis patients is quite high. Studies have demonstrated a correlation between hyperuricaemia and cardiovascular disease and treatment of hyperuricaemia reportedly reduces cardiovascular risk in patients with chronic kidney disease. However, whether hyperuricaemia treatment benefits cardiovascular outcomes in continuous ambulatory peritoneal dialysis (CAPD) patients is not yet known.
METHODS AND ANALYSES


This prospective, multicentre, double-blind, randomised controlled trial was designed to evaluate the effects of hyperuricaemia treatment on cardiovascular event risk in CAPD patients. Based on a power of 80%, with type I error α=0.05, two-sided test and 1:1 parallel control study, considering a dropout rate of 20%, a total of 548 eligible patients are expected to be randomly assigned to either the hyperuricaemia treatment group (febuxostat) or control group (placebo).
ETHICS AND DISSEMINATION


This study has been approved by the Medical Ethics Committee of the First Affiliated Hospital, Sun Yat-sen University and the ethics committees of other participating institutions. Written informed consent will be obtained from potential trial participants or authorised surrogates.The findings of the study will be disseminated through publications in peer-reviewed journals, and presentations at national and international conferences.
TRIAL REGISTRATION NUMBER


NCT03200210. 25 June 2017. The trial was started on 13 July 2017, and is expected to end by 31 December 2022. Till 20 Jan 2020, a total of 548 patients have been recruited.
PROTOCOL VERSION


The protocol version number and date are YLT-1604-V2.0 and 15 December 2016.",2020,Studies have demonstrated a correlation between hyperuricaemia and cardiovascular disease and treatment of hyperuricaemia reportedly reduces cardiovascular risk in patients with chronic kidney disease.,"['548 eligible patients', 'continuous ambulatory peritoneal dialysis (CAPD) patients', 'CAPD patients', 'patients with chronic kidney disease', 'peritoneal dialysis patients', 'peritoNeal diAlysis patients', '13 July 2017, and is expected to end by 31 December 2022', 'Till 20 Jan 2020, a total of 548 patients have been recruited']","['hyperuricaemia treatment', 'hyperuricaemia', 'hyperuricaemia treatment group (febuxostat) or control group (placebo']","['cardiovascular risk', 'cardiovascular event risk', 'cardiovascular outcoMes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031140', 'cui_str': 'Continuous ambulatory peritoneal dialysis'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0031139', 'cui_str': 'Peritoneal dialysis'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}]","[{'cui': 'C0740394', 'cui_str': 'Hyperuricemia'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C1273410', 'cui_str': 'Cardiovascular event risk'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",548.0,0.461533,Studies have demonstrated a correlation between hyperuricaemia and cardiovascular disease and treatment of hyperuricaemia reportedly reduces cardiovascular risk in patients with chronic kidney disease.,"[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'Department of Nephrology, Sun Yat-sen University First Affiliated Hospital，National Health Commission Key Laboratory of Nephrology (Sun Yat-sen University), Guangdong Provincial Key Laboratory of Nephrology, Guangzhou, Guangdong, China.'}, {'ForeName': 'Naya', 'Initials': 'N', 'LastName': 'Huang', 'Affiliation': 'Department of Nephrology, Sun Yat-sen University First Affiliated Hospital，National Health Commission Key Laboratory of Nephrology (Sun Yat-sen University), Guangdong Provincial Key Laboratory of Nephrology, Guangzhou, Guangdong, China.'}, {'ForeName': 'Haiping', 'Initials': 'H', 'LastName': 'Mao', 'Affiliation': 'Department of Nephrology, Sun Yat-sen University First Affiliated Hospital，National Health Commission Key Laboratory of Nephrology (Sun Yat-sen University), Guangdong Provincial Key Laboratory of Nephrology, Guangzhou, Guangdong, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Department of Nephrology, Sun Yat-sen University First Affiliated Hospital，National Health Commission Key Laboratory of Nephrology (Sun Yat-sen University), Guangdong Provincial Key Laboratory of Nephrology, Guangzhou, Guangdong, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Zhou', 'Affiliation': 'Department of Medical Statistics, Clinical Trials Unit, Sun Yat-sen University First Affiliated Hospital, Guangzhou, Guangdong, China.'}, {'ForeName': 'Lanping', 'Initials': 'L', 'LastName': 'Jiang', 'Affiliation': 'Department of Nephrology, Sun Yat-sen University First Affiliated Hospital，National Health Commission Key Laboratory of Nephrology (Sun Yat-sen University), Guangdong Provincial Key Laboratory of Nephrology, Guangzhou, Guangdong, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Ding', 'Affiliation': 'Medical Department, Wanbang Pharmaceutical Marketing and Distribution Co, Shanghai, China.'}, {'ForeName': 'Qiong', 'Initials': 'Q', 'LastName': 'Feng', 'Affiliation': 'Department of Nephrology, Sun Yat-sen University First Affiliated Hospital，National Health Commission Key Laboratory of Nephrology (Sun Yat-sen University), Guangdong Provincial Key Laboratory of Nephrology, Guangzhou, Guangdong, China.'}, {'ForeName': 'Xueqing', 'Initials': 'X', 'LastName': 'Yu', 'Affiliation': 'Department of Nephrology, Sun Yat-sen University First Affiliated Hospital，National Health Commission Key Laboratory of Nephrology (Sun Yat-sen University), Guangdong Provincial Key Laboratory of Nephrology, Guangzhou, Guangdong, China yuxq@mail.sysu.edu.cn.'}]",BMJ open,['10.1136/bmjopen-2020-037842']
3264,33040003,Rationale and design of a randomised controlled trial testing the effect of personalised diet in individuals with pre-diabetes or type 2 diabetes mellitus treated with metformin.,"INTRODUCTION


Metformin and diets aimed at promoting healthy body weight are the first line in treating type 2 diabetes mellitus (T2DM). Clinical practice, backed by clinical trials, suggests that many individuals do not reach glycaemic targets using this approach alone. The primary aim of the Personalised Medicine in Pre-diabetes-Towards Preventing Diabetes in Individuals at Risk (PREDICT) Study is to test the efficacy of personalised diet as adjuvant to metformin in improving glycaemic control in individuals with dysglycaemia.
METHODS AND ANALYSIS


PREDICT is a two-arm, parallel group, single-masked randomised controlled trial in adults with pre-diabetes or early-stage T2DM (with glycated haemoglobin (HbA1c) up to 8.0% (64 mmol/mol)), not treated with glucose-lowering medication. PREDICT is conducted at the Clinical Research Facility at the Garvan Institute of Medical Research (Sydney). Enrolment of participants commenced in December 2018 and expected to complete in December 2021. Participants are commenced on metformin (Extended Release, titrated to a target dose of 1500 mg/day) and randomised with equal allocation to either (1) the Personalised Nutrition Project algorithm-based diet or (2) low-fat high-dietary fibre diet, designed to provide caloric restriction (75%) in individuals with body mass index >25 kg/m 2 . Treatment duration is 6 months and participants visit the Clinical Research Facility five times over approximately 7 months. The primary outcome measure is HbA1c. The secondary outcomes are (1) time of interstitial glucose <7.8 mmol/L and (2) glycaemic variability (continuous glucose monitoring), (3) body weight, (4) fat mass and (5) abdominal visceral fat volume (dual-energy X-ray absorptiometry), serum (6) low-density lipoprotein cholesterol (7) high-density lipoprotein cholesterol and (8) triglycerides concentrations, (9) blood pressure, and (10) liver fat (Fibroscan).
ETHICS AND DISSEMINATION


The study has been approved by the St Vincent's Hospital Human Research Ethics Committee (File 17/080, Sydney, Australia) and the Weizmann Institutional Review Board (File 528-3, Rehovot, Israel). The findings will be published in peer-reviewed open access medical journals.
TRIAL REGISTRATION NUMBER


NCT03558867; Pre-results.",2020,The primary aim of the Personalised Medicine in Pre-diabetes-Towards Preventing Diabetes in Individuals at Risk (PREDICT),"['Pre-diabetes-Towards Preventing Diabetes in Individuals at Risk (PREDICT', 'individuals with pre-diabetes or type 2 diabetes mellitus treated with', 'adults with pre-diabetes or early-stage T2DM (with glycated haemoglobin (HbA1c) up to 8.0% (64 mmol/mol)), not treated with glucose-lowering medication', 'individuals with dysglycaemia']","['Personalised Nutrition Project algorithm-based diet or (2) low-fat high-dietary fibre diet, designed to provide caloric restriction', 'personalised diet', 'metformin', 'Personalised Medicine', 'Metformin']","['1) time of interstitial glucose <7.8\u2009mmol/L and (2) glycaemic variability (continuous glucose monitoring), (3) body weight, (4) fat mass and (5) abdominal visceral fat volume (dual-energy X-ray absorptiometry), serum (6) low-density lipoprotein cholesterol (7) high-density lipoprotein cholesterol and (8) triglycerides concentrations, (9) blood pressure, and (10) liver fat (Fibroscan', 'HbA1c']","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0362046', 'cui_str': 'Prediabetes'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0242970', 'cui_str': 'Low fat diet'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C1135809', 'cui_str': 'Decreased energy diet'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1522203', 'cui_str': 'Interstitial route'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0549399', 'cui_str': 'Low density lipoprotein increased'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0065055', 'cui_str': 'lipoprotein cholesterol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}]",,0.0948852,The primary aim of the Personalised Medicine in Pre-diabetes-Towards Preventing Diabetes in Individuals at Risk (PREDICT),"[{'ForeName': 'Thaw D', 'Initials': 'TD', 'LastName': 'Htet', 'Affiliation': 'Healthy Ageing Theme, Garvan Institute of Medical Research, Sydney, New South Wales, Australia.'}, {'ForeName': 'Anastasia', 'Initials': 'A', 'LastName': 'Godneva', 'Affiliation': 'Department of Computer Science & Applied Mathematics, Weizmann Institute of Science, Rehovot, Israel.'}, {'ForeName': 'Zhixin', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Mark Wainwright Analytical Centre, UNSW, Sydney, New South Wales, Australia.'}, {'ForeName': 'Eliza', 'Initials': 'E', 'LastName': 'Chalmers', 'Affiliation': 'Healthy Ageing Theme, Garvan Institute of Medical Research, Sydney, New South Wales, Australia.'}, {'ForeName': 'Dmitry', 'Initials': 'D', 'LastName': 'Kolobkov', 'Affiliation': 'Department of Computer Science & Applied Mathematics, Weizmann Institute of Science, Rehovot, Israel.'}, {'ForeName': 'Jennifer R', 'Initials': 'JR', 'LastName': 'Snaith', 'Affiliation': 'Healthy Ageing Theme, Garvan Institute of Medical Research, Sydney, New South Wales, Australia.'}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Richens', 'Affiliation': 'Healthy Ageing Theme, Garvan Institute of Medical Research, Sydney, New South Wales, Australia.'}, {'ForeName': 'Krisztina', 'Initials': 'K', 'LastName': 'Toth', 'Affiliation': 'Healthy Ageing Theme, Garvan Institute of Medical Research, Sydney, New South Wales, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Danta', 'Affiliation': ""St Vincent's Clinical School, UNSW, Sydney, New South Wales, Australia.""}, {'ForeName': 'Tien-Ming', 'Initials': 'TM', 'LastName': 'Hng', 'Affiliation': 'Diabetes and Endocrinology, Blacktown Mount Druitt Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Eran', 'Initials': 'E', 'LastName': 'Elinav', 'Affiliation': 'Department of Immunology, Weizmann Institute of Science, Rehovot, Israel.'}, {'ForeName': 'Eran', 'Initials': 'E', 'LastName': 'Segal', 'Affiliation': 'Department of Computer Science & Applied Mathematics, Weizmann Institute of Science, Rehovot, Israel.'}, {'ForeName': 'Jerry R', 'Initials': 'JR', 'LastName': 'Greenfield', 'Affiliation': 'Healthy Ageing Theme, Garvan Institute of Medical Research, Sydney, New South Wales, Australia.'}, {'ForeName': 'Dorit', 'Initials': 'D', 'LastName': 'Samocha-Bonet', 'Affiliation': 'Healthy Ageing Theme, Garvan Institute of Medical Research, Sydney, New South Wales, Australia d.samochabonet@garvan.org.au.'}]",BMJ open,['10.1136/bmjopen-2020-037859']
3265,33040755,Alcohol-impregnated caps and ambulatory central-line-associated bloodstream infections (CLABSIs): A randomized clinical trial.,"OBJECTIVE


To evaluate the effect of 70% isopropyl alcohol-impregnated central venous catheter caps on ambulatory central-line-associated bloodstream infections (CLABSIs) in pediatric hematology-oncology patients.
DESIGN


This study was a 24-month, cluster-randomized, 2 period, crossover clinical trial.
SETTING


The study was conducted in 15 pediatric healthcare institutions, including 16 pediatric hematology-oncology clinics.
PARTICIPANTS


All patients with an external central line followed at 1 of the 16 hematology-oncology clinics.
INTERVENTION


Usual ambulatory central-line care per each institution using 70% isopropyl alcohol-impregnated caps at home compared to usual ambulatory central-line care in each institution without using 70% isopropyl alcohol-impregnated caps.
RESULTS


Of the 16 participating clinics, 15 clinics completed both assignment periods. As assigned, there was no reduction in CLABSI incidence in clinics using 70% isopropyl alcohol-impregnated caps (1.23 per 1,000 days) compared with standard practices (1.38 per 1,000 days; adjusted incidence rate ratio [aIRR], 0.83; 95% CI, 0.63-1.11). In the per-protocol population, there was a reduction in positive blood culture incidence in clinics using 70% isopropyl alcohol-impregnated caps (1.51 per 1,000 days) compared with standard practices (1.88 per 1,000 days; aIRR, 0.72; 95% CI, 0.52-0.99). No adverse events were reported.
CONCLUSIONS


Isopropyl alcohol-impregnated central-line caps did not lead to a statistically significant reduction in CLABSI rates in ambulatory hematology-oncology patients. In the per-protocol analysis, there was a statistically significant decrease in positive blood cultures. Larger trials are needed to elucidate the impact of 70% isopropyl alcohol-impregnated caps in the ambulatory setting.
REGISTRATION


ClinicalTrials.gov; NCT02351258.",2020,"CONCLUSIONS


Isopropyl alcohol-impregnated central-line caps did not lead to a statistically significant reduction in CLABSI rates in ambulatory hematology-oncology patients.","['All patients with an external central line followed at 1 of the 16 hematology-oncology clinics', '16 participating clinics', 'ambulatory hematology-oncology patients', 'pediatric hematology-oncology patients', '15 pediatric healthcare institutions, including 16 pediatric hematology-oncology clinics']","['Usual ambulatory central-line care per each institution using 70% isopropyl alcohol-impregnated caps at home compared to usual ambulatory central-line care in each institution without using 70% isopropyl alcohol-impregnated caps', '70% isopropyl alcohol-impregnated central venous catheter caps', 'Alcohol-impregnated caps and ambulatory central-line-associated bloodstream infections (CLABSIs', 'Isopropyl alcohol-impregnated central-line caps', 'isopropyl alcohol-impregnated caps']","['CLABSI incidence', 'adverse events', 'positive blood cultures', 'CLABSI rates', 'positive blood culture incidence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C1145640', 'cui_str': 'Central venous catheter'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0018941', 'cui_str': 'Blood test'}, {'cui': 'C3839015', 'cui_str': 'Oncology clinic'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C1518927', 'cui_str': 'Pediatric hematology oncology'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C1279810', 'cui_str': 'Care of central line'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0022237', 'cui_str': 'Isopropyl Alcohol'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C1145640', 'cui_str': 'Central venous catheter'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C3161235', 'cui_str': 'CLABSI - central line associated bloodstream infection'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0740299', 'cui_str': 'Blood culture positive for microorganism'}]",15.0,0.0760498,"CONCLUSIONS


Isopropyl alcohol-impregnated central-line caps did not lead to a statistically significant reduction in CLABSI rates in ambulatory hematology-oncology patients.","[{'ForeName': 'Aaron M', 'Initials': 'AM', 'LastName': 'Milstone', 'Affiliation': 'Department of Pediatrics, Division of Infectious Diseases, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Rosenberg', 'Affiliation': 'Department of Pediatrics, Division of Quality and Safety, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Gayane', 'Initials': 'G', 'LastName': 'Yenokyan', 'Affiliation': 'Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Danielle W', 'Initials': 'DW', 'LastName': 'Koontz', 'Affiliation': 'Department of Pediatrics, Division of Infectious Diseases, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Marlene R', 'Initials': 'MR', 'LastName': 'Miller', 'Affiliation': 'Department of Pediatrics, Division of Quality and Safety, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Infection control and hospital epidemiology,['10.1017/ice.2020.467']
3266,33048267,Negative Life Events as Predictors of Anxiety Outcomes: An Examination of Event Type.,"Long-term follow-up studies of anxiety treatment have found that greater exposure to negative life events (NLEs) predicts poorer anxiety outcomes, but none have examined whether specific types of NLEs are differentially associated with child outcomes. This study examined the frequency of NLEs and whether specific types of NLEs were associated with increased risk of having an anxiety disorder 6.5 years post randomization. Participants were 319 adolescents and adults, ages 11 to 26 (M = 17), enrolled in Child/Adolescent Anxiety Multimodal Extended Long-term Study. At their first follow-up visit, participants completed a diagnostic interview and a 40-item Life Events Scale that reflected whether specific events occurred since their last post treatment assessment. Life events were categorized into domains (i.e., family, academic, health, and social) via researcher consensus. Participants reported having experienced an average of four NLEs. Participants with an anxiety disorder at follow-up were significantly more likely to have failed a grade in school (OR = 5.9) and experienced a negative change in acceptance by peers (OR = 4.9; ps < 0.001). After controlling for gender, age, race, and SES, a greater number of NLEs in the academic domain increased the odds of having an anxiety disorder at follow-up (OR = 2.4, p < 0.001). No other domains were predictive of disorder status at follow-up. Findings highlight the value of examining specific NLEs in relation to the long-term child anxiety outcomes.",2020,"After controlling for gender, age, race, and SES, a greater number of NLEs in the academic domain increased the odds of having an anxiety disorder at follow-up (OR = 2.4, p < 0.001).","['M\u2009=\u200917), enrolled in Child/Adolescent Anxiety', 'Participants were 319 adolescents and adults, ages 11 to 26']",[],"['odds of having an anxiety disorder', 'Anxiety']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}]",[],"[{'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",319.0,0.0272756,"After controlling for gender, age, race, and SES, a greater number of NLEs in the academic domain increased the odds of having an anxiety disorder at follow-up (OR = 2.4, p < 0.001).","[{'ForeName': 'Elizabeth P', 'Initials': 'EP', 'LastName': 'Casline', 'Affiliation': 'Department of Psychology, University of Miami, Coral Gables, FL, USA.'}, {'ForeName': 'Golda S', 'Initials': 'GS', 'LastName': 'Ginsburg', 'Affiliation': 'Department of Psychiatry, University of Connecticut School of Medicine, Farmington, CT, USA. gginsburg@uchc.edu.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Piacentini', 'Affiliation': 'Division of Child and Adolescent Psychiatry, UCLA Semel Institute for Neuroscience and Human Behavior, Los Angeles, CA, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Compton', 'Affiliation': 'Department of Psychiatry and Behavioral Medicine, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Kendall', 'Affiliation': 'Department of Psychology, Temple University, Philadelphia, PA, USA.'}]",Journal of abnormal child psychology,['10.1007/s10802-020-00711-x']
3267,33048300,Approval of Itolizumab for COVID-19: A Premature Decision or Need of The Hour?,"Itolizumab is a first-in-class anti-CD6 monoclonal antibody that was initially developed for various cancers and was later developed and approved in India for treatment of moderate to severe chronic plaque psoriasis in 2013. This drug is now being re-purposed for COVID-19. The potential utility of itolizumab in COVID-19, based on its unique mechanism of action in ameliorating cytokine release syndrome (CRS), was proposed first in Cuba with approval of a single-arm clinical trial and expanded access use. Subsequently, a phase II, open-label, randomized, placebo-controlled trial has been conducted in 30 COVID-19 patients in India after receiving regulatory permission. Based on the results, the Indian drug regulatory agency recently approved itolizumab in July 2020 for 'restricted emergency use' for the treatment of CRS in moderate to severe acute respiratory distress syndrome (ARDS) due to COVID-19. This has drawn sharp criticism within the scientific community, with the approval being granted on the basis of a relatively small phase II trial, without conduct of a conventional phase III trial, and lacking availability of the claimed supportive real-world evidence in the public domain to date. In a global scenario where finding a successful treatment for COVID-19 is of utmost priority, a biologic agent has been re-purposed and approved with a successfully completed RCT, in a country where cases and mortality due to COVID-19 are growing exponentially. However, instead of welcoming the approval with open arms, many doubts are being raised. This is an issue that needs to be considered and dealt with sensitively, as well as scientifically.",2020,"The potential utility of itolizumab in COVID-19, based on its unique mechanism of action in ameliorating cytokine release syndrome (CRS), was proposed first in Cuba with approval of a single-arm clinical trial and expanded access use.",['30 COVID-19 patients in India after receiving regulatory permission'],"['itolizumab', 'placebo', 'Itolizumab']",[],"[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0521104', 'cui_str': 'With permission of'}]","[{'cui': 'C2987424', 'cui_str': 'itolizumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],30.0,0.048248,"The potential utility of itolizumab in COVID-19, based on its unique mechanism of action in ameliorating cytokine release syndrome (CRS), was proposed first in Cuba with approval of a single-arm clinical trial and expanded access use.","[{'ForeName': 'Shubham', 'Initials': 'S', 'LastName': 'Atal', 'Affiliation': 'Department of Pharmacology, All India Institute of Medical Sciences Bhopal, 3rd Floor, Medical College Building, Saket Nagar, Bhopal, 462020, India.'}, {'ForeName': 'Zeenat', 'Initials': 'Z', 'LastName': 'Fatima', 'Affiliation': 'Department of Pharmacology, All India Institute of Medical Sciences Bhopal, 3rd Floor, Medical College Building, Saket Nagar, Bhopal, 462020, India. zeenat.sr2018@aiimsbhopal.edu.in.'}, {'ForeName': 'Sadasivam', 'Initials': 'S', 'LastName': 'Balakrishnan', 'Affiliation': 'Department of Pharmacology, All India Institute of Medical Sciences Bhopal, 3rd Floor, Medical College Building, Saket Nagar, Bhopal, 462020, India.'}]","BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy",['10.1007/s40259-020-00448-5']
3268,33050893,"Oral health behavior among school children aged 11-13 years in Saveh, Iran: an evaluation of a theory-driven intervention.","BACKGROUND


Good oral health (OH) is essential for physical, social, mental health, and overall quality of life. This study assessed the usefulness of the theory of planned behavior (TPB) in changing oral health-related behaviors among school children aged 11-13 years in Saveh, Iran.
METHODS


In this descriptive before and after study, participants were sixth-grade students at single sex primary schools in Saveh city, Iran. We recruited 356 school children in 2019. Using simple random sampling, a male and a female school per district were allocated to the experimental group and the remaining schools to the control group. Our planned oral health education consisted of four one-hour training sessions over 1 week. The first session familiarized the participants with important information about OH. In the second session, we applied a brain storming exercise to identify the benefits and barriers to flossing and brushing. In the third session, a short film about correct brushing and dental flossing technique was shown and research team also used role-playing to correct any mistakes. In the final session students were taught about the importance and the application of OH planning and given forms to help plan for brushing.
RESULTS


Participants for the study included 356 students (180 in the experimental group and 176 in the control group) who completed the post-test questionnaire. The mean age ± standard deviation was 11.55 years ±0.93 in the experimental group and 11.58 years ±1.01 in the control group. After the intervention, the paired t-test indicated a significant difference between the mean and standard deviation of the action plan and coping plan constructs in the experimental group before and after the intervention (p < 0.05). Covariance analysis indicated a significant difference between scores of intervention and control groups under statistical control of post-test in two groups (covariate) after a peer-led education program (post-test) (p < 0.05).
CONCLUSION


A shortage of professional health workers in education settings together with the ease, usefulness and low-cost of this peer-led method, suggest further steps should be taken to implement it more widely to improve and enhance primary school aged students' oral health behavior.",2020,"Covariance analysis indicated a significant difference between scores of intervention and control groups under statistical control of post-test in two groups (covariate) after a peer-led education program (post-test) (p < 0.05).
","['participants were sixth-grade students at single sex primary schools in Saveh city, Iran', '356 school children in 2019', 'school children aged 11-13\u2009years in Saveh, Iran', 'male and a female school per district', 'Participants for the study included 356 students (180 in the experimental group and 176 in the control group) who completed the post-test questionnaire', ""primary school aged students' oral health behavior""]","['OH planning and given forms to help plan for brushing', 'planned behavior (TPB']","['Oral health behavior', 'mean age\u2009±\u2009standard deviation', 'mean and standard deviation of the action plan and coping plan constructs']","[{'cui': 'C0205440', 'cui_str': 'Sixth'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0260267', 'cui_str': 'School child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018727', 'cui_str': 'Health Planning'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0040461', 'cui_str': 'Brushing of teeth'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C1273866', 'cui_str': 'Action plan (community)'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0012931', 'cui_str': 'Recombinant DNA'}]",356.0,0.0209224,"Covariance analysis indicated a significant difference between scores of intervention and control groups under statistical control of post-test in two groups (covariate) after a peer-led education program (post-test) (p < 0.05).
","[{'ForeName': 'Mahmood', 'Initials': 'M', 'LastName': 'Karimy', 'Affiliation': 'Department of Public Health, Faculty of Health, Social Determinants of Health Research Center, Saveh University of medical sciences, Saveh, Iran.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Higgs', 'Affiliation': 'Department of Public Health, School of Psychology and Public Health, La Trobe University, Melbourne, Australia.'}, {'ForeName': 'Shaghaygh Solayman', 'Initials': 'SS', 'LastName': 'Abadi', 'Affiliation': 'Department of Public Health, Faculty of Health, Social Determinants of Health Research Center, Saveh University of medical sciences, Saveh, Iran.'}, {'ForeName': 'Bahram', 'Initials': 'B', 'LastName': 'Armoon', 'Affiliation': 'Department of Public Health, Faculty of Health, Social Determinants of Health Research Center, Saveh University of medical sciences, Saveh, Iran. Bahramarmun@gmail.com.'}, {'ForeName': 'Marzieh', 'Initials': 'M', 'LastName': 'Araban', 'Affiliation': 'Department of health education and promotion, Social Determinants of Health Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Rouhani', 'Affiliation': 'Internal medicine department, faculty of medicine, Arak University of medical sciences, Arak, Iran.'}, {'ForeName': 'Fereshteh', 'Initials': 'F', 'LastName': 'Zamani-Alavijeh', 'Affiliation': 'Department of health education and promotion, School of Health, Isfahan University of Medical Sciences, Isfahan, Iran.'}]",BMC pediatrics,['10.1186/s12887-020-02381-6']
3269,33050947,An adaptive randomised placebo controlled phase II trial of antivirals for COVID-19 infection (VIRCO): A structured summary of a study protocol for a randomised controlled trial.,"OBJECTIVES


Primary objective: To determine the efficacy of a candidate antiviral on time to virological cure compared to standard of care within 14 days of randomisation Secondary objectives: • To determine the safety of the antiviral • To determine the clinical benefit of the antiviral over placebo according to the WHO 7-point ordinal scale • To determine the clinical benefit of the antiviral over placebo on time to resolution of clinical symptoms • To determine the effect of the antiviral over placebo on biomarkers of inflammation and immune activation TRIAL DESIGN: This is a multi-centre, triple-blind, randomised placebo controlled phase II, 2-arm trial with parallel-group design with allocation ratio 1:1.
PARTICIPANTS


Inclusion Criteria: • Provision of informed consent by the participant • Age ≥18 years • Confirmed SARS-CoV-2 by nucleic acid testing in the past 5 days • COVID-19 related symptom initiation within 5 days • Female patients of childbearing potential must have a negative pregnancy test at Screening. Female patients of childbearing potential and fertile male patients who are sexually active with a female of childbearing potential must use highly effective methods of contraception throughout the study and for 1 week following the last dose of study treatment.
EXCLUSION CRITERIA


• Known allergy to the study medication • Is on another clinical trial investigating an antiviral treatment for COVID-19 • Pregnancy • Patients with severe hepatic dysfunction equivalent to Grade C in the Child-Pugh classification • Patients with renal impairment requiring dialysis • Is deemed by the Investigator to be ineligible for any reason Participants will be recruited from, and the study visits will take place at Alfred Hospital, Monash Health, Austin Health in Victoria, Australia for hospitalised participants as well as recruitment in the community in participants homes for eligible people not requiring hospitalisation.
INTERVENTION AND COMPARATOR


The first candidate antiviral is favipiravir Arm 1: Favipiravir 1800 mg favipiravir BD on Day 1 followed by 800 mg BD favipiravir for the next 13 days. Arm 2: Placebo MAIN OUTCOMES: Primary outcome: Time to virological cure as defined by 2 successive throat (or combined nose/throat) swabs negative for SARS-CoV-2 by nucleic acid testing during the 14 days after enrolment.
RANDOMISATION


Randomisation performed at the Alfred Hospital Clinical Trials Pharmacy using computer generated block-randomisation lists with 6 participants per block. Within each block half of the participants will be randomised to the candidate antiviral and the other half to placebo. Randomisation is stratified by study site, with participants enrolled in the community considered as a study site.
BLINDING (MASKING)


Study participants, study investigators and the study statistician will be blinded to treatment allocation.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)


The study aims to recruit 190 people (95/arm) with the first candidate antiviral favipiravir TRIAL STATUS: Protocol version 2.0 Dated 31-Jul-2020. Recruitment will take place between July 2020 and December 2020.
TRIAL REGISTRATION


clinicaltrials.gov NCT04445467 First posted 24-Jun-2020 FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,The study aims to recruit 190 people (95/arm) with the first candidate antiviral favipiravir TRIAL STATUS:,"['COVID-19 infection (VIRCO', 'Inclusion Criteria: • Provision of informed consent by the participant • Age ≥18 years •', 'participants homes for eligible people not requiring hospitalisation', '190 people (95/arm) with the first candidate antiviral favipiravir TRIAL STATUS', 'Female patients of childbearing potential and fertile male patients who are sexually active with a female of childbearing potential', 'COVID-19 • Pregnancy • Patients with severe hepatic dysfunction equivalent to Grade C in the Child-Pugh classification •', 'participants enrolled in the community considered as a study site', 'Patients with renal impairment requiring dialysis •', 'Female patients of childbearing potential']","['antiviral •', '24-Jun-2020', 'placebo', 'Placebo', 'Favipiravir 1800 mg favipiravir BD']","['WHO 7-point ordinal scale •', 'Time to virological cure as defined by 2 successive throat (or combined nose/throat) swabs negative for SARS-CoV-2 by nucleic acid testing']","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C4517622', 'cui_str': '190'}, {'cui': 'C0003451', 'cui_str': 'Antiviral'}, {'cui': 'C1138226', 'cui_str': 'favipiravir'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015895', 'cui_str': 'Ability to conceive'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0241028', 'cui_str': 'Sexually active'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0086565', 'cui_str': 'Abnormal liver function'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0441807', 'cui_str': 'Grade C'}, {'cui': 'C4050412', 'cui_str': 'Child-Pugh score'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}]","[{'cui': 'C0003451', 'cui_str': 'Antiviral'}, {'cui': 'C0162508', 'cui_str': 'jun Oncogene'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1138226', 'cui_str': 'favipiravir'}]","[{'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205466', 'cui_str': 'Virologic'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0031354', 'cui_str': 'Pharyngeal structure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0183753', 'cui_str': 'Swab'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0200932', 'cui_str': 'Nucleic acid amplification'}]",,0.508829,The study aims to recruit 190 people (95/arm) with the first candidate antiviral favipiravir TRIAL STATUS:,"[{'ForeName': 'James H', 'Initials': 'JH', 'LastName': 'McMahon', 'Affiliation': 'Department of Infectious Diseases, Alfred Hospital and Monash University, Melbourne, Australia. james.mcmahon@monash.edu.'}, {'ForeName': 'Jillian S Y', 'Initials': 'JSY', 'LastName': 'Lau', 'Affiliation': 'Department of Infectious Diseases, Alfred Hospital and Monash University, Melbourne, Australia.'}, {'ForeName': 'Janine', 'Initials': 'J', 'LastName': 'Roney', 'Affiliation': 'Department of Infectious Diseases, Alfred Hospital and Monash University, Melbourne, Australia.'}, {'ForeName': 'Benjamin A', 'Initials': 'BA', 'LastName': 'Rogers', 'Affiliation': 'Department of Infectious Diseases, Monash Medical Centre, Melbourne, Australia.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Trubiano', 'Affiliation': 'Department of Infectious Diseases, Austin Hospital, Melbourne, Australia.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Sasadeusz', 'Affiliation': 'Department of Infectious Diseases, Royal Melbourne Hospital, Melbourne, Australia.'}, {'ForeName': 'James S', 'Initials': 'JS', 'LastName': 'Molton', 'Affiliation': 'Department of Infectious Diseases, Western Health, Melbourne, Australia.'}, {'ForeName': 'Bradley', 'Initials': 'B', 'LastName': 'Gardiner', 'Affiliation': 'Department of Infectious Diseases, Alfred Hospital and Monash University, Melbourne, Australia.'}, {'ForeName': 'Sue J', 'Initials': 'SJ', 'LastName': 'Lee', 'Affiliation': 'Department of Infectious Diseases, Alfred Hospital and Monash University, Melbourne, Australia.'}, {'ForeName': 'Jennifer F', 'Initials': 'JF', 'LastName': 'Hoy', 'Affiliation': 'Department of Infectious Diseases, Alfred Hospital and Monash University, Melbourne, Australia.'}, {'ForeName': 'Allen', 'Initials': 'A', 'LastName': 'Cheng', 'Affiliation': 'Department of Infectious Diseases, Alfred Hospital and Monash University, Melbourne, Australia.'}, {'ForeName': 'Anton Y', 'Initials': 'AY', 'LastName': 'Peleg', 'Affiliation': 'Department of Infectious Diseases, Alfred Hospital and Monash University, Melbourne, Australia.'}]",Trials,['10.1186/s13063-020-04766-5']
3270,33050952,Adjuvant psychotherapy in early-stage bipolar disorder: study protocol for a randomized controlled trial.,"BACKGROUND


Bipolar disorders are serious illnesses with a chronic course and a high rate of relapse. Typically, bipolar disorders onset during adolescence or early adulthood, with patients experiencing significant personal and social costs as a consequence of their illness. Despite this, to date, there is limited (controlled) evidence regarding the effectiveness of psychotherapy during the critical stages of the disorder (e.g., early onset). Some preliminary studies suggest that targeted, tailored early interventions in particular may improve disease prognosis. The proposed study examines the effectiveness of group psychotherapy on relapse prevention, global adaptive functioning, and neuropsychological functioning in early-stage bipolar disorder.
METHODS


In this multicenter randomized controlled trial (RCT), 300 patients with bipolar disorder are randomized to one of two group psychotherapies: Specific Emotional-Cognitive Therapy (SECT; intervention group) or Emotion-Focused Supportive Therapy (EFST; active control group). Each therapy comprises of a total of 48-h sessions (delivered once a month) over a period of 4 months. Assessments take place at baseline (t1); 6 months follow-up, i.e., post-intervention (t2); 12 months follow-up (t3); and 18 months follow-up (t4), whereby 18 months follow-up is the primary time point of interest.
DISCUSSION


The goal of this study is to test the effects of an innovative, specific group therapy relative to an active control condition in terms of rates of relapse, global functioning, and neuropsychological functioning. Pending the outcomes of the trial, it will be possible to establish a firm evidence base for accessible group psychotherapy adjuvant to routine psychiatric care for individuals with bipolar disorder.
TRIAL REGISTRATION


USA: ClinicalTrials.gov NCT02506322 . Registered on 19 December 2014; Germany: German Clinical Trials Register DRKS00006013 . Registered on21 May 2015.",2020,"The proposed study examines the effectiveness of group psychotherapy on relapse prevention, global adaptive functioning, and neuropsychological functioning in early-stage bipolar disorder.
","['300 patients with bipolar disorder', 'early-stage bipolar disorder', 'individuals with bipolar disorder']","['Adjuvant psychotherapy', 'psychotherapies: Specific Emotional-Cognitive Therapy (SECT; intervention group) or Emotion-Focused Supportive Therapy (EFST; active control group']","['rates of relapse, global functioning, and neuropsychological functioning', 'relapse prevention, global adaptive functioning, and neuropsychological functioning']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0344211', 'cui_str': 'Support'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0679867', 'cui_str': 'Relapse prevention'}]",300.0,0.28574,"The proposed study examines the effectiveness of group psychotherapy on relapse prevention, global adaptive functioning, and neuropsychological functioning in early-stage bipolar disorder.
","[{'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Stamm', 'Affiliation': 'Department of Clinical Psychiatry and Psychotherapy, Brandenburg Medical School Theodor Fontane, Neuruppin, Germany. thomas.stamm@mhb-fontane.de.'}, {'ForeName': 'Julia C', 'Initials': 'JC', 'LastName': 'Zwick', 'Affiliation': 'Department of Psychology, Clinical Psychology and Psychotherapy, University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': ""O'Malley"", 'Affiliation': 'Department of Clinical Psychiatry and Psychotherapy, Brandenburg Medical School Theodor Fontane, Neuruppin, Germany.'}, {'ForeName': 'Lene-Marie', 'Initials': 'LM', 'LastName': 'Sondergeld', 'Affiliation': 'Department of Clinical Psychiatry and Psychotherapy, Brandenburg Medical School Theodor Fontane, Neuruppin, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Hautzinger', 'Affiliation': 'Department of Psychology, Clinical Psychology and Psychotherapy, University of Tübingen, Tübingen, Germany.'}]",Trials,['10.1186/s13063-020-04755-8']
3271,33051212,Targeting rehabilitation to improve outcomes after total knee arthroplasty in patients at risk of poor outcomes: randomised controlled trial.,"OBJECTIVE


To evaluate whether a progressive course of outpatient physiotherapy offers superior outcomes to a single physiotherapy review and home exercise based intervention when targeted at patients with a predicted poor outcome after total knee arthroplasty.
DESIGN


Parallel group randomised controlled trial.
SETTING


13 secondary and tertiary care centres in the UK providing postoperative physiotherapy.
PARTICIPANTS


334 participants with knee osteoarthritis who were defined as at risk of a poor outcome after total knee arthroplasty, based on the Oxford knee score, at six weeks postoperatively. 163 were allocated to therapist led outpatient rehabilitation and 171 to a home exercise based protocol.
INTERVENTIONS


All participants were reviewed by a physiotherapist and commenced 18 sessions of rehabilitation over six weeks, either as therapist led outpatient rehabilitation (progressive goal oriented functional rehabilitation protocol, modified weekly in one-one contact sessions) or as physiotherapy review followed by a home exercise based regimen (without progressive input from a physiotherapist).
MAIN OUTCOME MEASURES


Primary outcome was Oxford knee score at 52 weeks, with a 4 point difference between groups considered to be clinically meaningful. Secondary outcomes included additional patient reported outcome measures of pain and function at 14, 26, and 52 weeks post-surgery.
RESULTS


334 patients were randomised. Eight were lost to follow-up. Intervention compliance was more than 85%. The between group difference in Oxford knee score at 52 weeks was 1.91 (95% confidence interval -0.18 to 3.99) points, favouring the outpatient rehabilitation arm (P=0.07). When all time point data were analysed, the between group difference in Oxford knee score was a non-clinically meaningful 2.25 points (0.61 to 3.90, P=0.01). No between group differences were found for secondary outcomes of average pain (0.25 points, -0.78 to 0.28, P=0.36) or worst pain (0.22 points, -0.71 to 0.41, P=0.50) at 52 weeks or earlier time points, or of satisfaction with outcome (odds ratio 1.07, 95% confidence interval 0.71 to 1.62, P=0.75) or post-intervention function (4.64 seconds, 95% confidence interval -14.25 to 4.96, P=0.34).
CONCLUSIONS


Outpatient therapist led rehabilitation was not superior to a single physiotherapist review and home exercise based regimen in patients at risk of poor outcomes after total knee arthroplasty. No clinically relevant differences were observed across primary or secondary outcome measures.
TRIALS REGISTRATION


Current Controlled Trials ISRCTN23357609 and ClinicalTrials.gov NCT01849445.",2020,The between group difference in Oxford knee score at 52 weeks was 1.91,"['patients at risk of poor outcomes after total knee arthroplasty', '334 participants with knee osteoarthritis who were defined as at risk of a poor outcome after total knee arthroplasty, based on the Oxford knee score, at six weeks postoperatively', '13 secondary and tertiary care centres in the UK providing postoperative physiotherapy', '334 patients were randomised', 'patients with a predicted poor outcome after total knee arthroplasty', 'patients at risk of poor outcomes']","['therapist led outpatient rehabilitation and 171 to a home exercise based protocol', 'therapist led outpatient rehabilitation (progressive goal oriented functional rehabilitation protocol, modified weekly in one-one contact sessions) or as physiotherapy review followed by a home exercise based regimen (without progressive input from a physiotherapist']","['Oxford knee score', 'worst pain', 'Intervention compliance', 'pain and function', 'average pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C4517729', 'cui_str': '334'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1997265', 'cui_str': 'Oxford knee score'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}]","[{'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0454532', 'cui_str': 'Functional rehabilitation'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}]","[{'cui': 'C1997265', 'cui_str': 'Oxford knee score'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",334.0,0.151286,The between group difference in Oxford knee score at 52 weeks was 1.91,"[{'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Hamilton', 'Affiliation': 'Department of Orthopaedics and Trauma, University of Edinburgh, Edinburgh EH16 4SB, UK d.f.hamilton@ed.ac.uk.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Beard', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Barker', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Gary J', 'Initials': 'GJ', 'LastName': 'Macfarlane', 'Affiliation': 'Aberdeen Centre for Arthritis and Musculoskeletal Health (Epidemiology) Group, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Christopher E', 'Initials': 'CE', 'LastName': 'Tuck', 'Affiliation': 'Usher Institute of Population Health, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Stoddart', 'Affiliation': 'Usher Institute of Population Health, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Wilton', 'Affiliation': 'Department of Orthopaedics, Royal Derby Hospital, Derby, UK.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Hutchinson', 'Affiliation': 'Department of Orthopaedic Surgery, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Gordon D', 'Initials': 'GD', 'LastName': 'Murray', 'Affiliation': 'Usher Institute of Population Health, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'A Hamish R W', 'Initials': 'AHRW', 'LastName': 'Simpson', 'Affiliation': 'Department of Orthopaedics and Trauma, University of Edinburgh, Edinburgh EH16 4SB, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ (Clinical research ed.),['10.1136/bmj.m3576']
3272,33051226,PREventive effect of FENestration with and without clipping on post-kidney transplantation lymphatic complications (PREFEN): study protocol for a randomised controlled trial.,"INTRODUCTION


Peritoneal fenestration is an effective preventive method for reducing the rate of lymphatic complications in kidney transplantation (KTx). The size of the fenestration plays an important role in its effectiveness. A large peritoneal window is no longer indicated, due to herniation and difficulties in performing biopsies. Small preventive fenestration is effective but will be closed too early. The aim of this study is to evaluate whether metal clips around the edges of a small fenestration result in optimal effects with minimum fenestration size.
METHODS AND ANALYSIS


This trial has been initiated in July 2019 and is expected to last for 2 and a half years. All patients older than 18 years, who receive kidneys from deceased donors, will be included. The kidney recipients will be randomly allocated to either a control arm (small fenestration alone) or an intervention arm (small fenestration with clipping). All fenestrations will be round, maximum 2 cm, and close to the kidney hilum. Clipping will be performed with eight metal clips around the peritoneal window (360°) in every 45° in an oblique position. The primary endpoint is the incidence of symptomatic post-KTx lymphatic complications, which require interventional treatment within 6 months after KTx. Secondary endpoints are intraoperative and postoperative outcomes, including blood loss, operation time, severity grade of lymphocele/lymphorrhea and relative symptoms.
ETHICS AND DISSEMINATION


This protocol study received approval from the Ethics Committee of the University of Heidelberg (Registration Number S-318/2017). A Standard Protocol Items: Recommendations for Interventional Trials checklist is available for this protocol. The results will be disseminated through peer-reviewed journals and conference presentations.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov Registry (NCT03682627).",2020,"INTRODUCTION


Peritoneal fenestration is an effective preventive method for reducing the rate of lymphatic complications in kidney transplantation (KTx).","['kidney transplantation (KTx', 'All patients older than 18 years, who receive kidneys from deceased donors, will be included', 'post-kidney transplantation lymphatic complications (PREFEN']","['control arm (small fenestration alone) or an intervention arm (small fenestration with clipping', 'metal clips', 'FENestration with and without clipping']","['intraoperative and postoperative outcomes, including blood loss, operation time, severity grade of lymphocele/lymphorrhea and relative symptoms', 'incidence of symptomatic post-KTx lymphatic complications']","[{'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0024235', 'cui_str': 'Structure of lymphatic system'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0015825', 'cui_str': 'Inner ear fenestration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0025552', 'cui_str': 'Metal'}, {'cui': 'C0175722', 'cui_str': 'Clip'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0024248', 'cui_str': 'Lymphocele'}, {'cui': 'C0333258', 'cui_str': 'Extravasation of lymph'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0024235', 'cui_str': 'Structure of lymphatic system'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",,0.211961,"INTRODUCTION


Peritoneal fenestration is an effective preventive method for reducing the rate of lymphatic complications in kidney transplantation (KTx).","[{'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Golriz', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Baden-Württemberg, Germany.'}, {'ForeName': 'Mohammadsadegh', 'Initials': 'M', 'LastName': 'Sabagh', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Baden-Württemberg, Germany.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Mohammadi', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Baden-Württemberg, Germany.'}, {'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Ghamarnejad', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Baden-Württemberg, Germany.'}, {'ForeName': 'Elias', 'Initials': 'E', 'LastName': 'Khajeh', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Baden-Württemberg, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Mieth', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Baden-Württemberg, Germany.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Al-Saeedi', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Baden-Württemberg, Germany.'}, {'ForeName': 'Markus K', 'Initials': 'MK', 'LastName': 'Diener', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Baden-Württemberg, Germany.'}, {'ForeName': 'André L', 'Initials': 'AL', 'LastName': 'Mihaljevic', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Baden-Württemberg, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Morath', 'Affiliation': 'Department of Nephrology, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Zeier', 'Affiliation': 'Department of Nephrology, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Yakup', 'Initials': 'Y', 'LastName': 'Kulu', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Baden-Württemberg, Germany.'}, {'ForeName': 'Arianeb', 'Initials': 'A', 'LastName': 'Mehrabi', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Baden-Württemberg, Germany arianeb.mehrabi@med.uni-heidelberg.de.'}]",BMJ open,['10.1136/bmjopen-2019-032286']
3273,33051228,"Effect of clindamycin and a live biotherapeutic on the reproductive outcomes of IVF patients with abnormal vaginal microbiota: protocol for a double-blind, placebo-controlled multicentre trial.","INTRODUCTION


Recent studies in in vitro fertilisation (IVF) patients have associated abnormal vaginal microbiota (AVM) with poor clinical pregnancy rates of 6%-9% per embryo transfer. The biological plausibility for this finding is hypothesised to be ascending infection to the endometrium which in turn hampers embryo implantation. New molecular based diagnosis may offer advantages compared to microscopical diagnosis of AVM which has huge inter-study variability ranging from 4 to 38%; however, the important question is whether screening and treatment of AVM would improve reproductive outcomes in IVF patients. Herein, we describe a protocol for an ongoing double-blind, placebo-controlled multicentre trial of IVF patients diagnosed with AVM and randomised in three parallel groups 1:1:1.
METHODS AND ANALYSIS


This is a drug intervention study where IVF patients will be screened for AVM, using a qPCR assay targeting  Atopobium vaginae  and  Gardnerella vaginalis . If positive, patients will be randomised to one of the three study arms. The first arm consists of clindamycin 300 mg ×2 daily for 7 days followed by vaginal  Lactobacillus crispatus  CTV-05 until clinical pregnancy scan week 7-9. The second arm consists of clindamycin and placebo  L. crispatus  CTV-05, whereas patients in the third arm will be treated with placebo/placebo. We used a superiority design to estimate that active treatment in both arms will increase the primary outcome, clinical pregnancy rate per embryo transfer, from 20% to 40%. A potential difference between the two active arms was considered exploratory. With a power of 80% and an alpha at 5%, the sample size is estimated to be 333 patients randomised. A pre-planned interim analysis is scheduled at 167 patients randomised.
ETHICS AND DISSEMINATION


All patients have to give informed consent. Dissemination of results is ensured in clinical trial agreements whether they be positive or not. Ethics committee, Central Denmark Region approved this protocol.
TRIAL REGISTRATION NUMBER


ICH-GCP monitored trial, EudraCT 2016-002385-31; Pre-results.",2020,"We used a superiority design to estimate that active treatment in both arms will increase the primary outcome, clinical pregnancy rate per embryo transfer, from 20% to 40%.","['167 patients randomised', 'IVF patients diagnosed with AVM and randomised in three parallel groups 1:1:1', 'IVF patients', '333 patients randomised', 'IVF patients with abnormal vaginal microbiota']","['placebo/placebo', 'clindamycin and a live biotherapeutic', 'placebo', 'clindamycin and placebo', 'clindamycin']",['clinical pregnancy rate per embryo transfer'],"[{'cui': 'C4517595', 'cui_str': '167'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517724', 'cui_str': '333'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0008947', 'cui_str': 'Clindamycin'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0013938', 'cui_str': 'Embryo transfer'}]",,0.748669,"We used a superiority design to estimate that active treatment in both arms will increase the primary outcome, clinical pregnancy rate per embryo transfer, from 20% to 40%.","[{'ForeName': 'Thor', 'Initials': 'T', 'LastName': 'Haahr', 'Affiliation': 'Department of Clinical Medicine, Aarhus Universitet, Aarhus, Denmark thohaa@rm.dk.'}, {'ForeName': 'Nina La Cour', 'Initials': 'NC', 'LastName': 'Freiesleben', 'Affiliation': 'The Fertility Clinic, Hvidovre University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Pinborg', 'Affiliation': 'The Fertility Clinic, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Henriette Svarre', 'Initials': 'HS', 'LastName': 'Nielsen', 'Affiliation': 'The Fertility Clinic, Hvidovre University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Vibeke', 'Initials': 'V', 'LastName': 'Hartvig', 'Affiliation': 'Stork Fertility Clinic, Copenhagen, Denmark.'}, {'ForeName': 'Anne-Lis', 'Initials': 'AL', 'LastName': 'Mikkelsen', 'Affiliation': 'The Fertility Clinic, Sjællands Universitetshospital Køge, Koge, Sjaelland, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Parks', 'Affiliation': 'Osel Inc, Mountain View, California, USA.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Uldbjerg', 'Affiliation': 'Department of Clinical Medicine, Aarhus Universitet, Aarhus, Denmark.'}, {'ForeName': 'Jørgen Skov', 'Initials': 'JS', 'LastName': 'Jensen', 'Affiliation': 'Department of Reproductive Microbiology, Statens Serum Institute, Copenhagen, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Humaidan', 'Affiliation': 'Department of Clinical Medicine, Aarhus Universitet, Aarhus, Denmark.'}]",BMJ open,['10.1136/bmjopen-2019-035866']
3274,33052251,The Impact of App-Delivered Mindfulness Meditation on Functional Connectivity and Self-Reported Mindfulness Among Health Profession Trainees.,"Objectives


Previous research indicates that mindfulness meditation reduces anxiety and depression and enhances well-being. We examined the impact of app-delivered mindfulness meditation on resting state functional MRI (fMRI) connectivity among physician assistant (PA) students and surgery residents.
Methods


PA students and residents were randomized to receive a popular meditation app or to wait-list control group. Before and after the 8-week meditation period, we acquired fMRI scans of participants' resting state, and participants completed a self-report measure of mindfulness. We used a 2 × 2, within- and between-group factorial design and leveraged a whole-brain connectome approach to examine changes in within- and between-network connectivity across the entire brain, and to examine whether changes in connectivity were associated with app use or to changes in self-reported mindfulness.
Results


Meditation practitioners exhibited significantly stronger connectivity between the frontoparietal network and the left and right nucleus accumbens and between the default mode (DMN) and salience networks, among other regions. Mindfulness practice time was correlated with increased connectivity between the lateral parietal cortex and the supramarginal gyrus, which were also positively correlated with increased scores on the ""Describing"" subscale of the Five Facet Mindfulness Questionnaire between baseline and post-meditation. These findings are consistent with previous research indicating that mindfulness-based interventions alter functional connectivity within the DMN and between the DMN and other networks both during meditation and at rest, as well as increased connectivity in systems important for emotion and reward.
Conclusions


Recent commentaries call for healthcare provider and trainee wellness programs that are sustainable and preventive in nature rather than reactive; these data indicate that even brief sessions of app-delivered mindfulness practice are associated with functional connectivity changes in a dose-dependent manner.",2020,"Mindfulness practice time was correlated with increased connectivity between the lateral parietal cortex and the supramarginal gyrus, which were also positively correlated with increased scores on the ""Describing"" subscale of the Five Facet Mindfulness Questionnaire between baseline and post-meditation.","['physician assistant (PA) students and surgery residents', 'Health Profession Trainees', 'Methods\n\n\nPA students and residents']","['App-Delivered Mindfulness Meditation', 'popular meditation app or to wait-list control group', 'app-delivered mindfulness meditation', 'mindfulness meditation']","['Describing"" subscale of the Five Facet Mindfulness Questionnaire', 'Functional Connectivity and Self-Reported Mindfulness', 'resting state functional MRI (fMRI) connectivity', 'anxiety and depression and enhances well-being', 'Mindfulness practice time']","[{'cui': 'C0031833', 'cui_str': 'Physician assistant'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0018722', 'cui_str': 'Health Professions'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0222679', 'cui_str': 'Structure of articular surface of bone'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",5.0,0.0163758,"Mindfulness practice time was correlated with increased connectivity between the lateral parietal cortex and the supramarginal gyrus, which were also positively correlated with increased scores on the ""Describing"" subscale of the Five Facet Mindfulness Questionnaire between baseline and post-meditation.","[{'ForeName': 'Jeremy L', 'Initials': 'JL', 'LastName': 'Smith', 'Affiliation': 'Department of Radiology and Imaging Sciences, Emory University, Atlanta, GA USA.'}, {'ForeName': 'Jason W', 'Initials': 'JW', 'LastName': 'Allen', 'Affiliation': 'Department of Radiology and Imaging Sciences, Emory University, Atlanta, GA USA.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Haack', 'Affiliation': 'Department of Surgery, Emory University, Atlanta, GA USA.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Wehrmeyer', 'Affiliation': 'Department of Family and Preventive Medicine, Emory University, 1841 Clifton Road NE, Suite 507, Atlanta, GA 30329 USA.'}, {'ForeName': 'Kayley', 'Initials': 'K', 'LastName': 'Alden', 'Affiliation': 'Department of Family and Preventive Medicine, Emory University, 1841 Clifton Road NE, Suite 507, Atlanta, GA 30329 USA.'}, {'ForeName': 'Maha B', 'Initials': 'MB', 'LastName': 'Lund', 'Affiliation': 'Department of Family and Preventive Medicine, Physician Assistant Program, Emory University, Atlanta, GA USA.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Mascaro', 'Affiliation': 'Department of Family and Preventive Medicine, Emory University, 1841 Clifton Road NE, Suite 507, Atlanta, GA 30329 USA.'}]",Mindfulness,['10.1007/s12671-020-01502-7']
3275,33052270,Cardio-Protective Effects of Multiport Antegrade Cold Blood Cardioplegia Versus Antegrade Cold Blood Cardioplegia in Patients With Left Ventricular Systolic Dysfunction Undergoing Conventional Coronary Artery Bypass Grafting.,"Introduction The aim of this study was to compare the in-hospital outcomes of multiport antegrade cold blood cardioplegia through vein grafts versus conventional antegrade cold blood cardioplegia in patients with left ventricle systolic dysfunction who underwent coronary artery bypass grafting (CABG). Methods This prospective, randomized clinical study was comprised of patients undergoing on-pump CABG at the Ch. Pervaiz Elahi Institute of Cardiology in Multan, Pakistan from November 18, 2018 to December 17, 2019. Patients with multivessel coronary artery disease and left ventricular systolic dysfunction (ejection fraction < 50%) were included. In Group A (N = 73), multiport antegrade cold blood vein graft cardioplegia was given after every distal anastomosis completed for myocardial preservation. In Group B (N = 73), conventional antegrade cold blood cardioplegia was given for myocardial preservation. Results Spontaneous rhythm (without defibrillation applied) after cross-clamp removal was higher in Group A than in Group B (93.3% vs. 85.2%, p < 0.05). Duration of support, ventilation time, and hospital stay were also significantly lower in Group A than in Group B with p = 0.00001, p = 0.03, and p = 0.002, respectively. Intra-aortic balloon pump insertion (4.1% vs. 23.0%, p = 0.02) and operative mortality (0.5% vs. 4.0%, p = 0.35) were also lower in Group A than in Group B. Postoperative left ventricular ejection fraction (LVEF) increased more in Group A than in Group B, and the postoperative LVEF mean value was 44.68% in Group A versus 41.26% in Group B (p = 0.02). Conclusion Multiport vein graft blood cardioplegia provides superior myocardial protection in patients with left ventricular systolic dysfunction who underwent CABG. It is also easy to administer, so this technique can be adopted as a routine method for myocardial protection in patients with left ventricular dysfunction planned for on-pump CABG.",2020,"Intra-aortic balloon pump insertion (4.1% vs. 23.0%, p = 0.02) and operative mortality (0.5% vs. 4.0%, p = 0.35) were also lower in Group A than in Group B. Postoperative left ventricular ejection fraction (LVEF) increased more in Group A than in Group B, and the postoperative LVEF mean value was 44.68% in Group A versus 41.26% in Group B (p = 0.02).","['Patients with multivessel coronary artery disease and left ventricular systolic dysfunction (ejection fraction < 50%) were included', 'Patients', 'patients with left ventricle systolic dysfunction who underwent coronary artery bypass grafting (CABG', 'Pervaiz Elahi Institute of Cardiology in Multan, Pakistan\xa0from November 18, 2018\xa0to December 17, 2019', 'patients undergoing on-pump CABG at the Ch', 'patients with left ventricular dysfunction planned for on-pump CABG', 'patients with left ventricular systolic dysfunction who underwent CABG']","['Multiport vein graft blood cardioplegia', 'Multiport Antegrade Cold Blood Cardioplegia Versus Antegrade Cold Blood Cardioplegia', 'multiport antegrade cold blood vein graft cardioplegia', 'Conventional Coronary Artery Bypass Grafting', 'conventional antegrade cold blood cardioplegia', 'multiport antegrade cold blood cardioplegia through vein grafts versus conventional antegrade cold blood cardioplegia']","['Duration of support, ventilation time, and hospital stay', 'Postoperative left ventricular ejection fraction (LVEF', 'operative mortality', 'postoperative LVEF mean value']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C1277187', 'cui_str': 'Left ventricular systolic dysfunction'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0225897', 'cui_str': 'Left cardiac ventricular structure'}, {'cui': 'C0749225', 'cui_str': 'Systolic dysfunction'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0242973', 'cui_str': 'Ventricular dysfunction'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}]","[{'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0018791', 'cui_str': 'Induced cardioplegia'}, {'cui': 'C0589502', 'cui_str': 'Antegrade direction'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.030641,"Intra-aortic balloon pump insertion (4.1% vs. 23.0%, p = 0.02) and operative mortality (0.5% vs. 4.0%, p = 0.35) were also lower in Group A than in Group B. Postoperative left ventricular ejection fraction (LVEF) increased more in Group A than in Group B, and the postoperative LVEF mean value was 44.68% in Group A versus 41.26% in Group B (p = 0.02).","[{'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Ali', 'Affiliation': 'Cardiac Surgery, Chaudhry Pervaiz Elahi Institute of Cardiology, Multan, PAK.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Moeen', 'Affiliation': 'Cardiac Surgery, Chaudhry Pervaiz Elahi Institute of Cardiology, Multan, PAK.'}, {'ForeName': 'Iftikhar', 'Initials': 'I', 'LastName': 'Paras', 'Affiliation': 'Cardiac Surgery, Chaudhry Pervaiz Elahi Institute of Cardiology, Multan, PAK.'}, {'ForeName': 'Waqas', 'Initials': 'W', 'LastName': 'Hamid', 'Affiliation': 'Cardiac Surgery, Sheikh Zayed Medical College/Hospital, Rahim Yar Khan, PAK.'}, {'ForeName': 'Saadat', 'Initials': 'S', 'LastName': 'Khan', 'Affiliation': 'Echocardiography, Tabba Heart Institute, Karachi, PAK.'}, {'ForeName': 'Muhammad Hamid', 'Initials': 'MH', 'LastName': 'Chaudhary', 'Affiliation': 'Cardiac Surgery, Chaudhry Pervaiz Elahi Institute of Cardiology, Multan, PAK.'}]",Cureus,['10.7759/cureus.10308']
3276,33052285,Creation and Evaluation of a Cesarean Section Simulator Training Program for Novice Obstetric Surgeons.,"BACKGROUND


We evaluated a novel simulation-based cesarean section training program to teach critical techniques for cesarean section and hemorrhage management.  Methods: This was a prospective educational intervention. After Institutional Review Board approval, we recruited Obstetrics and Gynecology, Family Medicine, and General Surgery residents at three hospitals. All participants received didactic education. Participants were then randomized into two arms with one group to receive task-trainer based training and the other no training. Afterwards, all residents had their performance of a complete cesarean section and management of a post-partum hemorrhage evaluated on a high-fidelity simulator. Evaluators were blinded to randomization.
EXPERIENCE


Thirty-three participants were recruited between July 2017 and January 2019. There were 19 trainees in the control group and 14 in the intervention group. The intervention group scored significantly higher on performance of the cesarean delivery (p-value 0.007), hemorrhage management (p-value 0.0002), and overall skill (p-value 0.008). There were no differences in the other categories.
CONCLUSION


Participants trained with a combination of didactic education and task-trainers versus didactic education alone performed significantly better on all procedural aspects of a cesarean section and hemorrhage management on a high-fidelity simulator, demonstrating that simulation-based training allows trainees to gain procedural experience while decreasing patient risk.",2020,"The intervention group scored significantly higher on performance of the cesarean delivery (p-value 0.007), hemorrhage management (p-value 0.0002), and overall skill (p-value 0.008).","['Thirty-three participants were recruited between July 2017 and January 2019', 'recruited Obstetrics and Gynecology, Family Medicine, and General Surgery residents at three hospitals', 'Novice Obstetric Surgeons']","['didactic education', 'Cesarean Section Simulator Training Program', 'didactic education\xa0and task-trainers versus didactic education alone', 'task-trainer based training and the other no training']","['overall skill', 'complete cesarean section and management of a post-partum hemorrhage', 'performance of the cesarean delivery', 'hemorrhage management']","[{'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C1274104', 'cui_str': 'Obstetrics and gynecology'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C1274039', 'cui_str': 'General surgery'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0183309', 'cui_str': 'Simulator'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0453962', 'cui_str': 'Trainers'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0032797', 'cui_str': 'Postpartum hemorrhage'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",33.0,0.0850487,"The intervention group scored significantly higher on performance of the cesarean delivery (p-value 0.007), hemorrhage management (p-value 0.0002), and overall skill (p-value 0.008).","[{'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Foglia', 'Affiliation': 'Maternal Fetal Medicine, Womack Army Medical Center, Fort Bragg, USA.'}, {'ForeName': 'Allison A', 'Initials': 'AA', 'LastName': 'Eubanks', 'Affiliation': 'Obstetrics and Gynecology, Walter Reed National Military Medical Center, Bethesda, USA.'}, {'ForeName': 'Logan C', 'Initials': 'LC', 'LastName': 'Peterson', 'Affiliation': 'Obstetrics and Gynecology, Walter Reed National Military Medical Center, Bethesda, USA.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Hickey', 'Affiliation': 'Maternal Fetal Medicine, Walter Reed National Military Medical Center, Bethesda, USA.'}, {'ForeName': 'Crystal B', 'Initials': 'CB', 'LastName': 'Hammons', 'Affiliation': 'Obstetrics and Gynecology, Madigan Army Medical Center, Tacoma, USA.'}, {'ForeName': 'Lindsey B', 'Initials': 'LB', 'LastName': 'Borgia', 'Affiliation': 'Obstetrics and Gynecology, Fort Belvoir Community Hospital, Fort Belvoir, USA.'}, {'ForeName': 'Morgan R', 'Initials': 'MR', 'LastName': 'Light', 'Affiliation': 'Obstetrics and Gynecology, Walter Reed National Military Medical Center, Bethesda, USA.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Jackson', 'Affiliation': 'Obstetrics and Gynecology, Walter Reed National Military Medical Center, Bethesda, USA.'}, {'ForeName': 'Shad', 'Initials': 'S', 'LastName': 'Deering', 'Affiliation': 'Obstetrics and Gynecology, Christus Health, San Antonio, USA.'}]",Cureus,['10.7759/cureus.10324']
3277,33035593,Functional and cognitive responses to caffeine intake in middle-aged women are dose depending.,"Middle-aged women display many physiological and cognitive alterations resulting from aging and physical inactivity as well as other changes that occur as a function of menopause. Caffeine consumption is highest in this age with women having a particular greater sensitivity to caffeine than men. Its effects on functional and cognitive functions are controversial and seem to depend on the dose intake. This study aimed to assess the effect of low (100mg) and high (400mg) doses of caffeine consumption on cognitive (simple reaction time) and functional (upper and low body muscle endurance, aerobic endurance and functional mobility) performances. These performances were evaluated in 19 healthy middle-aged women by the 30-Second Chair Stand test for lower body muscle endurance, the 30sec Arm Curl Test for upper body muscle endurance, the 2-Minute Step test for aerobic endurance, The Timed Up and Go test for functional mobility and the simple reaction time test for reaction time, 60min after a treatment capsule intake (100mg caffeine/400mg caffeine/placebo). Low caffeine consumption significantly improved (p<.005) cognitive performance, while high caffeine consumption did not. However, the functional performance significantly improved (p<.05) after high caffeine consumption but not after low caffeine consumption. Except, the functional mobility performance significantly improved (p<.05) after both low and high caffeine consumption with better improvement (p<.05) after the high dose. In conclusion, low caffeine consumption improved cognitive performance and high caffeine consumption improved functional performance but the functional mobility improved after both low and high caffeine consumption in middleaged women.",2020,"However, the functional performance significantly improved (p<.05) after high caffeine consumption but not after low caffeine consumption.","['middleaged women', '19 healthy middle-aged women by the', 'middle-aged women', 'Middle-aged women']","['caffeine consumption', '30-Second Chair Stand test for lower body muscle endurance, the 30sec Arm Curl Test for upper body muscle endurance, the 2-Minute Step test for aerobic endurance, The Timed Up and Go test for functional mobility and the simple reaction time test for reaction time, 60min after a treatment capsule intake (100mg caffeine/400mg caffeine/placebo']","['Low caffeine consumption significantly improved (p<.005) cognitive performance', 'cognitive performance', 'Functional and cognitive responses', 'cognitive (simple reaction time) and functional (upper and low body muscle endurance, aerobic endurance and functional mobility) performances', 'functional mobility performance', 'Caffeine consumption', 'functional performance', 'functional mobility']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}]","[{'cui': 'C0948365', 'cui_str': 'Caffeine consumption'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1268088', 'cui_str': 'Lower body structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0010474', 'cui_str': ""Curling's ulcers""}, {'cui': 'C1268087', 'cui_str': 'Upper body structure'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0087028', 'cui_str': 'Step Test'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0948365', 'cui_str': 'Caffeine consumption'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C1268088', 'cui_str': 'Lower body structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}]",19.0,0.026942,"However, the functional performance significantly improved (p<.05) after high caffeine consumption but not after low caffeine consumption.","[{'ForeName': 'Fatma Ben', 'Initials': 'FB', 'LastName': 'Waer', 'Affiliation': 'Research Laboratory Education, Motricité, Sport et Santé, EM2S, LR19JS01, High Institute of Sport and Physical Education of Sfax, University of Sfax, Tunisia. Electronic address: fatmaelwaer123@gmail.com.'}, {'ForeName': 'Rabeb', 'Initials': 'R', 'LastName': 'Laatar', 'Affiliation': 'Research Laboratory Education, Motricité, Sport et Santé, EM2S, LR19JS01, High Institute of Sport and Physical Education of Sfax, University of Sfax, Tunisia.'}, {'ForeName': 'Ghada', 'Initials': 'G', 'LastName': 'Jouira', 'Affiliation': 'Research Laboratory Education, Motricité, Sport et Santé, EM2S, LR19JS01, High Institute of Sport and Physical Education of Sfax, University of Sfax, Tunisia.'}, {'ForeName': 'Selim', 'Initials': 'S', 'LastName': 'Srihi', 'Affiliation': 'Research Laboratory Education, Motricité, Sport et Santé, EM2S, LR19JS01, High Institute of Sport and Physical Education of Sfax, University of Sfax, Tunisia.'}, {'ForeName': 'Haithem', 'Initials': 'H', 'LastName': 'Rebai', 'Affiliation': 'Research Laboratory Education, Motricité, Sport et Santé, EM2S, LR19JS01, High Institute of Sport and Physical Education of Sfax, University of Sfax, Tunisia.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Sahli', 'Affiliation': 'Research Laboratory Education, Motricité, Sport et Santé, EM2S, LR19JS01, High Institute of Sport and Physical Education of Sfax, University of Sfax, Tunisia.'}]",Behavioural brain research,['10.1016/j.bbr.2020.112956']
3278,33044203,Effects of insole on the less affected side during execution of treadmill walking training on gait ability in chronic stroke patients: A preliminary study.,"BACKGROUND


People who have had hemiplegic stoke generally move more weight to the unaffected side than the affected side, resulting in asymmetrical posture and decreased ability in walking.
OBJECTIVES


This study sought to investigate the effect of inducing a weight shift to the affected side by raising the shoe height of the less affected side using an insole during the execution of treadmill training on gait ability in people with chronic stroke.
METHODS


The subjects were randomly assigned into two groups: insole on less affected side for execution of treadmill walking training (ILTW) group and normal treadmill training (NTW) group. The treadmill training was conducted for 30 minutes per session, 5 times a week, for 4 weeks. A gait analyzer based on body center, Functional Gait Assessment (FGA), Figure-of-Eight Walk Test (F8WT), and 6 min Walk Test (6 MWT), was measured before first intervention and after twentieth treadmill training intervention (Trial registration number is KCT0003830).
RESULTS


The results revealed statistically significant differences between the two groups in the Speed, Cadence, Stride Length/Height, Stride Length, Double Support Duration, Single Support Duration, FGA, F8WT, and 6 MWT of the gait test. In the ILTW group, statistically significant improvements were observed in the Speed, Stride Length/Height, Stride Length, Stance Phase Duration, Swing Phase Duration, Double Support Duration, Single Support Duration, FGA, F8WT, and 6 MWT after execution of training, while in the NTW group, statistically significant improvements were observed only in Speed, Cadence, FGA, F8WT, and 6 MWT.
CONCLUSIONS


ILTW, more than NTW, may improve walking ability in people with chronic stroke as it increases the weight-support ratio by adjusting the shoe height of the unaffected side using an insole.",2020,"In the ILTW group, statistically significant improvements were observed in the Speed, Stride Length/Height, Stride Length, Stance Phase Duration, Swing Phase Duration, Double Support Duration, Single Support Duration, FGA, F8WT, and 6 MWT after execution of training, while in the NTW group, statistically significant improvements were observed only in Speed, Cadence, FGA, F8WT, and 6 MWT.
","['chronic stroke patients', 'People who have had hemiplegic stoke', 'people with chronic stroke']","['side for execution of treadmill walking training (ILTW) group and normal treadmill training (NTW', 'treadmill walking training', 'treadmill training']","['Speed, Stride Length/Height, Stride Length, Stance Phase Duration, Swing Phase Duration, Double Support Duration, Single Support Duration, FGA, F8WT, and 6\u200aMWT after execution of training', 'weight-support ratio', 'body center, Functional Gait Assessment (FGA), Figure-of-Eight Walk Test (F8WT), and 6 min Walk Test (6\u200aMWT', 'Speed, Cadence, FGA, F8WT, and 6\u200aMWT', 'gait ability', 'walking ability', 'Speed, Cadence, Stride Length/Height, Stride Length, Double Support Duration, Single Support Duration, FGA, F8WT, and 6\u200aMWT of the gait test']","[{'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C1278561', 'cui_str': 'Judicial execution'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205307', 'cui_str': 'Normal'}]","[{'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C1278561', 'cui_str': 'Judicial execution'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0559964', 'cui_str': 'Ability to walk'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",,0.0322436,"In the ILTW group, statistically significant improvements were observed in the Speed, Stride Length/Height, Stride Length, Stance Phase Duration, Swing Phase Duration, Double Support Duration, Single Support Duration, FGA, F8WT, and 6 MWT after execution of training, while in the NTW group, statistically significant improvements were observed only in Speed, Cadence, FGA, F8WT, and 6 MWT.
","[{'ForeName': 'Bora', 'Initials': 'B', 'LastName': 'An', 'Affiliation': 'Department of Physical Therapy, Raon Hue Hospital, Sinwol-ro, Yangcheon-gu, Seoul, Republic of Korea.'}, {'ForeName': 'Youngkeun', 'Initials': 'Y', 'LastName': 'Woo', 'Affiliation': 'Department of Physical Therapy, College of Medical Sciences, Jeonju University, Cheonjam-ro, Wansan-gu, Jeonju, Republic of Korea.'}, {'ForeName': 'Kyuenam', 'Initials': 'K', 'LastName': 'Park', 'Affiliation': 'Department of Physical Therapy, College of Medical Sciences, Jeonju University, Cheonjam-ro, Wansan-gu, Jeonju, Republic of Korea.'}, {'ForeName': 'Sujin', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Department of Physical Therapy, College of Medical Sciences, Jeonju University, Cheonjam-ro, Wansan-gu, Jeonju, Republic of Korea.'}]",Restorative neurology and neuroscience,['10.3233/RNN-201040']
3279,33044684,Efficacy and Safety of ABP 798: Results from the JASMINE Trial in Patients with Follicular Lymphoma in Comparison with Rituximab Reference Product.,"INTRODUCTION


ABP 798 is being developed as a biosimilar to rituximab reference product (RP), a CD20-directed cytolytic antibody that is approved in the US and EU for the treatment of non-Hodgkin lymphoma (NHL).
METHODS


This randomized, double-blind, comparative clinical study (JASMINE) evaluated the efficacy and safety of ABP 798 compared with rituximab RP. Adult, anti-CD20 treatment naïve patients diagnosed with grade 1, 2, or 3a follicular B-cell NHL expressing CD20 were randomized 1:1 to receive a 375 mg/m 2  infusion of either ABP 798 or rituximab RP once weekly for 4 weeks and at weeks 12 and 20. Tumor assessments were performed at baseline and weeks 12 and 28. Primary endpoint was the risk difference (RD) of overall response rate (ORR) of complete response, unconfirmed complete response, or partial response by week 28 based on data from central, independent, and blinded assessments of disease.
RESULTS


Of the 256 randomized patients, 254 were treated with ABP 798 (n = 128; 100%) or rituximab RP (n = 126; 98.4%); 96 (78.0%) patients in the ABP 798 group and 87 (70.2%) in the rituximab RP group had a best ORR by week 28. The point estimate of RD in ORR between ABP 798 and rituximab RP from the adjusted generalized linear model for stratification factors was 7.7%. Clinical equivalence was based on sequential testing of the one-sided 95% lower confidence limits and one-sided 95% upper confidence limits of RD in ORR (- 1.4% and 16.8%, respectively) which was within the prespecified non-inferiority margin (- 15%) and non-superiority margin (35.5%), respectively. Results of sensitivity analyses were consistent with the primary efficacy analysis. ABP 798 was also comparable to rituximab RP across additional secondary endpoints, further supporting the conclusion of similarity, and including: RD of ORR at week 12; trough serum concentrations; percent of patients with complete depletion of CD19+ cell count at day 8; safety; and immunogenicity.
CONCLUSIONS


These results support a conclusion of similar clinical efficacy between ABP 798 and rituximab RP in patients with follicular lymphoma.
NCT NUMBER


NCT02747043; first posted April 21, 2016.
EUDRACT NUMBER


2013-005,542-11; submitted 14 October, 2014.",2020,"Primary endpoint was the risk difference (RD) of overall response rate (ORR) of complete response, unconfirmed complete response, or partial response by week 28 based on data from central, independent, and blinded assessments of disease.
","['naïve patients diagnosed with grade 1, 2, or 3a follicular B-cell NHL expressing CD20', '256 randomized patients', 'patients with follicular lymphoma', 'Patients with Follicular Lymphoma in Comparison with Rituximab Reference Product']","['ABP', 'ABP 798 or rituximab RP', 'rituximab RP', 'anti-CD20 treatment']","['efficacy and safety', 'Efficacy and Safety', 'risk difference (RD) of overall response rate (ORR) of complete response, unconfirmed complete response, or partial response by week 28 based on data from central, independent, and blinded assessments of disease']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C1868944', 'cui_str': ""Follicular B-cell non-Hodgkin's lymphoma""}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0054946', 'cui_str': 'Lymphocyte antigen CD20'}, {'cui': 'C0024301', 'cui_str': 'Follicular lymphoma'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}]","[{'cui': 'C0001239', 'cui_str': 'Actin-binding protein'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0054946', 'cui_str': 'Lymphocyte antigen CD20'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",256.0,0.112772,"Primary endpoint was the risk difference (RD) of overall response rate (ORR) of complete response, unconfirmed complete response, or partial response by week 28 based on data from central, independent, and blinded assessments of disease.
","[{'ForeName': 'Dietger', 'Initials': 'D', 'LastName': 'Niederwieser', 'Affiliation': 'Division of Hematology and Oncology, University of Leipzig, Liebigstr. 19, 04106, Leipzig, Germany. Dietger.Niederwieser@medizin.uni-leipzig.de.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Hamm', 'Affiliation': 'Schulich School of Medicine, Western University, Windsor, ON, Canada.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Cobb', 'Affiliation': 'St. Vincent Frontier Cancer Center, Billings, MT, USA.'}, {'ForeName': 'Mindy', 'Initials': 'M', 'LastName': 'Mo', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Cecily', 'Initials': 'C', 'LastName': 'Forsyth', 'Affiliation': 'Gosford Hospital, Gosford, NSW, Australia.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Tucci', 'Affiliation': 'Hematology Department, ASST-Spedali Civili-Brescia, Brescia, Italy.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Hanes', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Delwail', 'Affiliation': 'Oncology-Hematology and Cell Therapy, Centre Hospitalier Universitaire de Poitiers, Poitiers, France.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Hajek', 'Affiliation': 'Department of Hematooncology, Faculty of Medicine, University Hospital Ostrava, University of Ostrava, Ostrava, Czech Republic.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Chien', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}]",Targeted oncology,['10.1007/s11523-020-00748-4']
3280,33039382,Early changes in appetite and energy expenditure are not associated to body weight and fat losses in pre-menopausal women living with overweight/obesity.,"BACKGROUND


The aim of the study was to investigate whether early changes (1-week) in energy balance-related measures would predict changes in body weight (BW) and fat losses in women living with overweight/obesity.
METHODS


BW, body composition (DXA), resting energy expenditure (REE)(indirect calorimetry), olfactory performance (Sniffin' Sticks), appetite and palatability (visual analogue scale) were measured at baseline, after a 1-week of caloric restriction as well as post-intervention (at 10 and 20 weeks) in a group of 30 women living with overweight/obesity.
RESULTS


A significant decrease in REE (p = 0.033) was noted after 1 week. Fasting desire to eat (p = 0.004), hunger (p = 0.001) and prospective food consumption (p = 0.001) all increased after 1 week. Similarly, significant increases in AUC SQ for desire to eat (p = 0.01), hunger (p = 0.005) and prospective food consumption (p = 0.001) were noted after 1 week. However, these early changes were not associated to final BW or FM losses at the end of the weight loss intervention.
CONCLUSION


Despite significant changes in REE and appetite soon after the onset of a BW loss intervention, these early changes do not seem to predict final BW or FM losses at the end of the program in women living with overweight/obesity.",2020,"Similarly, significant increases in AUC SQ for desire to eat (p = 0.01), hunger (p = 0.005) and prospective food consumption (p = 0.001) were noted after 1 week.","['pre-menopausal women living with overweight/obesity', '30 women living with overweight/obesity', 'women living with overweight/obesity']",[],"['appetite and energy expenditure', 'Fasting desire to eat', 'body weight (BW) and fat losses', 'prospective food consumption', 'final BW or FM losses', 'REE and appetite', 'hunger', ""body composition (DXA), resting energy expenditure (REE)(indirect calorimetry), olfactory performance (Sniffin' Sticks), appetite and palatability (visual analogue scale"", 'body weight and fat losses', 'REE', 'AUC SQ for desire to eat']","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]",[],"[{'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0006779', 'cui_str': 'Calorimetry'}, {'cui': 'C0037361', 'cui_str': 'Sense of smell, function'}, {'cui': 'C1706582', 'cui_str': 'Stick'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}]",30.0,0.0260886,"Similarly, significant increases in AUC SQ for desire to eat (p = 0.01), hunger (p = 0.005) and prospective food consumption (p = 0.001) were noted after 1 week.","[{'ForeName': 'Luzia Jaeger', 'Initials': 'LJ', 'LastName': 'Hintze', 'Affiliation': 'Behavioural Metabolic Research Unit, School of Human Kinetics, University of Ottawa, Ottawa, K1N 6N5, Canada.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Goldfield', 'Affiliation': ""Children's Hospital of Eastern Ontario Research Institute, Ottawa, K1H 8L1, Canada.""}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Séguin', 'Affiliation': 'Behavioural Metabolic Research Unit, School of Human Kinetics, University of Ottawa, Ottawa, K1N 6N5, Canada; Ryan Séguin is deceased.'}, {'ForeName': 'Aleck', 'Initials': 'A', 'LastName': 'Damphousse', 'Affiliation': 'Behavioural Metabolic Research Unit, School of Human Kinetics, University of Ottawa, Ottawa, K1N 6N5, Canada.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Riopel', 'Affiliation': 'Behavioural Metabolic Research Unit, School of Human Kinetics, University of Ottawa, Ottawa, K1N 6N5, Canada.'}, {'ForeName': 'Éric', 'Initials': 'É', 'LastName': 'Doucet', 'Affiliation': 'Behavioural Metabolic Research Unit, School of Human Kinetics, University of Ottawa, Ottawa, K1N 6N5, Canada. Electronic address: edoucet@uottawa.ca.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113201']
3281,33039944,"Shorter infusion time of ocrelizumab: Results from the randomized, double-blind ENSEMBLE PLUS substudy in patients with relapsing-remitting multiple sclerosis.","BACKGROUND


Ocrelizumab is an approved intravenously administered anti-CD20 antibody for multiple sclerosis (MS). Shortening the 600 mg infusion to 2 hours reduces the total site stay from 5.5-6 hours (approved infusion duration including mandatory pre-medication and post-infusion observation) to 4 hours. The safety profile of shorter-duration ocrelizumab infusions was investigated using results from ENSEMBLE PLUS.
METHODS


ENSEMBLE PLUS is a randomized, double-blind substudy to the single-arm ENSEMBLE study (NCT03085810). In ENSEMBLE, patients with early-stage relapsing-remitting MS received ocrelizumab 600 mg infusions every 24 weeks for 192 weeks. In ENSEMBLE PLUS, ocrelizumab 600 mg administered over the approved 3.5-hour infusion time (conventional duration) is compared with a 2-hour infusion (shorter duration); the durations of the initial infusions (2×300 mg, 14 days apart) were unaffected. The primary endpoint was the proportion of patients with infusion-related reactions (IRRs) following the first Randomized Dose.
RESULTS


From November 1, 2018, to December 13, 2019, 745 patients were randomized 1:1 to the conventional or shorter infusion group. At the first Randomized Dose, 99/373 patients (26.5%) in the conventional and 107/372 patients (28.8%) in the shorter infusion group experienced IRRs. The majority of IRRs were mild or moderate; >99% of all IRRs resolved without sequelae in both groups (conventional infusion group, 99/99; shorter infusion group, 106/107). No IRRs were serious, life-threatening, or fatal. No IRR-related discontinuations occurred. During the first Randomized Dose, 22/373 (5.9%) and 39/372 (10.5%) patients in the conventional and shorter infusion groups, respectively, had IRRs leading to infusion slowing/interruption. Adverse events were consistent with the known safety profile of ocrelizumab.
CONCLUSION


The rates and severity of IRRs were similar between conventional and shorter infusions. No new safety signals were detected. Shortening the infusion time to 2 hours reduces the total site stay time (including mandatory pre-medication/infusion/observation) from 5.5-6 hours to 4 hours, and may reduce patient and site staff burden. A short video summarizing the key results is provided in supplemental material.",2020,"The majority of IRRs were mild or moderate; >99% of all IRRs resolved without sequelae in both groups (conventional infusion group, 99/99; shorter infusion group, 106/107).","['patients with relapsing-remitting multiple sclerosis', 'patients with early-stage relapsing-remitting MS', 'From November 1, 2018, to December 13, 2019, 745 patients']","['ocrelizumab', 'PLUS', 'conventional or shorter infusion group']","['total site stay', 'total site stay time', 'proportion of patients with infusion-related reactions (IRRs', 'rates and severity of IRRs', 'Adverse events', 'serious, life-threatening, or fatal', 'IRRs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0751967', 'cui_str': 'Relapsing remitting multiple sclerosis'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}]","[{'cui': 'C1882138', 'cui_str': 'ocrelizumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}]",745.0,0.20051,"The majority of IRRs were mild or moderate; >99% of all IRRs resolved without sequelae in both groups (conventional infusion group, 99/99; shorter infusion group, 106/107).","[{'ForeName': 'H-P', 'Initials': 'HP', 'LastName': 'Hartung', 'Affiliation': 'Department of Neurology, UKD, Center of Neurology and Neuropsychiatry and LVR-Klinikum, Heinrich-Heine University Düsseldorf, Düsseldorf, Germany. Electronic address: hans-peter.hartung@uni-duesseldorf.de.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Berger', 'Affiliation': 'Department of Neurology, Medical University of Vienna, Währinger Gürtel 18-20 1090 Vienna, Austria.'}, {'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Bermel', 'Affiliation': 'Mellen Center for MS, Neurological Institute, Cleveland Clinic, 9500 Euclid Ave, Cleveland, OH44195, USA.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Brochet', 'Affiliation': 'INSERM U 1215, Neurocentre Magendie, University of Bordeaux, Bordeaux, France.'}, {'ForeName': 'W M', 'Initials': 'WM', 'LastName': 'Carroll', 'Affiliation': 'Department of Neurology, Sir Charles Gairdner Hospital, Perron Institute for Neurological and Translational Science, The University of Western Australia, Nedlands 6009, Australia.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Holmøy', 'Affiliation': 'Department of Neurology, Akershus University Hospital, PO Box 1000, 1478 Lørenskog, Norway; Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Karabudak', 'Affiliation': 'Department of Neurology, Hacettepe University Faculty of Medicine, Ankara, Turkey.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Killestein', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Neurology, MS Center Amsterdam, Amsterdam Neuroscience, Amsterdam, The Netherlands.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Nos', 'Affiliation': ""Centre d'Esclerosi Mútiple de Catalunya (Cemcat), Vall d'Hebron Hospital Universitari, 08035, Barcelona, Spain.""}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Patti', 'Affiliation': 'Department of Medical and Surgical Sciences and Advanced Technologies, GF Ingrassia, Neuroscience Section and Multiple Sclerosis Center, University of Catania PO Policlinico G Rodolico, Via Santa Sofia, 78 95123 Catania - Italy.'}, {'ForeName': 'A Perrin', 'Initials': 'AP', 'LastName': 'Ross', 'Affiliation': 'Loyola University Chicago, Chicago, Maywood, IL 60660, USA.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Vanopdenbosch', 'Affiliation': 'Department of Neurology, AZ Sint Jan Brugge Oostende, Ruddershove 10, 8000, Brugge, Belgium.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Vollmer', 'Affiliation': 'University of Colorado, Anschutz Medical Campus, 12631 East 17th St, Mail Stop B 182, Aurora, Colorado 80045, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Buffels', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Grenzacherstrasse 124, 4070 Basel, Switzerland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Garas', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Grenzacherstrasse 124, 4070 Basel, Switzerland.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Kadner', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Grenzacherstrasse 124, 4070 Basel, Switzerland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Manfrini', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Grenzacherstrasse 124, 4070 Basel, Switzerland.'}, {'ForeName': 'Q', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Grenzacherstrasse 124, 4070 Basel, Switzerland.'}, {'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'Freedman', 'Affiliation': 'University of Ottawa and the Ottawa Hospital Research Institute, Ottawa, ON, Canada.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2020.102492']
3282,33039988,Can children swallow tablets? Outcome data from a feasibility study to assess the acceptability of different-sized placebo tablets in children (creating acceptable tablets (CAT)).,"OBJECTIVE


Feasibility study to investigate the acceptability of different-sized placebo tablets in children aged 4-12 years.
DESIGN AND SETTING


Clinical Research Facilities, inpatient wards and outpatient clinics within a Regional Paediatric Hospital and/or District General Hospital. Healthy children and National Health Service (NHS) patients were asked to swallow three placebo tablets: 6 mm, 8 mm and 10 mm, smallest to largest. The researcher observed children's facial expressions and behaviours on swallowing and measured the volume of water consumed. Participants completed a questionnaire about the overall acceptability; including swallowability, taste and volume of water consumed. For analysis, participants were stratified by age: 4-8 years and 9-12 years.
RESULTS


The feasibility study led to an estimated recruitment rate of 0.8% for NHS inpatients and 211 healthy children over a 1-year period. In total, 55 participants were recruited, 30 to the younger group, of which 77% had never taken a tablet before. 84% of the 25 older children had previously taken a tablet. All participants attempted to swallow the smallest sized tablet. The children aged 4-8 years found the larger tablets easier to swallow, however the older children found little difference between the tablet sizes. The younger children required more water to swallow each tablet size compared with the older children where an increasing volume of water was consumed as tablet size increased. Taste was rated highly for both age groups. The 8 mm tablets were deemed the most acceptable tablet size by all participants.
CONCLUSION


Tablets are potentially an acceptable formulation for children aged 4-12 years. Most children aged 4-8 years who attempted to swallow tablets successfully did so. Recruitment of NHS inpatients to medicine acceptability studies is challenging, however, recruitment of children of staff proved an effective strategy. Valuable lessons have been learnt from this feasibility study which will inform the design of a larger definitive trial.",2020,"The children aged 4-8 years found the larger tablets easier to swallow, however the older children found little difference between the tablet sizes.","['participants were stratified by age: 4-8 years and 9-12 years', 'Clinical Research Facilities, inpatient wards and outpatient clinics within a Regional Paediatric Hospital and/or District General Hospital', 'inpatients and 211 healthy children over a 1-year period', 'Most children aged 4-8\u2009years who attempted to swallow tablets successfully did so', 'children (creating acceptable tablets (CAT', '25 older children', 'children aged 4-12 years', 'Healthy children and National Health Service (NHS) patients', '55 participants were recruited, 30 to the younger group, of which 77% had never taken a tablet before']","['NHS', 'placebo tablets']","[""children's facial expressions and behaviours on swallowing"", 'swallowability, taste and volume of water consumed']","[{'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0007366', 'cui_str': 'Catalan language'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027462', 'cui_str': 'National Health Services'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1515187', 'cui_str': 'Take'}]","[{'cui': 'C0027462', 'cui_str': 'National Health Services'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0039336', 'cui_str': 'Finding of sense of taste'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}]",55.0,0.202116,"The children aged 4-8 years found the larger tablets easier to swallow, however the older children found little difference between the tablet sizes.","[{'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Bracken', 'Affiliation': ""Paediatric Medicines Research Unit, Alder Hey Children's NHS Foundation Trust, Liverpool, UK.""}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'McDonough', 'Affiliation': ""Paediatric Medicines Research Unit, Alder Hey Children's NHS Foundation Trust, Liverpool, UK.""}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Ashleigh', 'Affiliation': ""NIHR Alder Hey Clinical Research Facility, Alder Hey Children's NHS Foundation Trust, Liverpool, UK.""}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Wilson', 'Affiliation': ""NIHR Alder Hey Clinical Research Facility, Alder Hey Children's NHS Foundation Trust, Liverpool, UK.""}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Shakeshaft', 'Affiliation': ""Paediatric Medicines Research Unit, Alder Hey Children's NHS Foundation Trust, Liverpool, UK.""}, {'ForeName': 'Udeme', 'Initials': 'U', 'LastName': 'Ohia', 'Affiliation': ""NIHR Alder Hey Clinical Research Facility, Alder Hey Children's NHS Foundation Trust, Liverpool, UK.""}, {'ForeName': 'Punam', 'Initials': 'P', 'LastName': 'Mistry', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Huw', 'Initials': 'H', 'LastName': 'Jones', 'Affiliation': 'Pediatric Services, Quotient Sciences, Nottingham, UK.'}, {'ForeName': 'Nazim', 'Initials': 'N', 'LastName': 'Kanji', 'Affiliation': 'Pediatric Services, Quotient Sciences, Nottingham, UK.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Liu', 'Affiliation': 'Department of Clinical and Pharmaceutical Sciences, University of Hertfordshire, Hatfield, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Peak', 'Affiliation': ""Paediatric Medicines Research Unit, Alder Hey Children's NHS Foundation Trust, Liverpool, UK Matthew.Peak@alderhey.nhs.uk.""}]",BMJ open,['10.1136/bmjopen-2019-036508']
3283,33040736,Optimizing smoke alarm signals: Testing the effectiveness of children's smoke alarms for sleeping adults.,"BACKGROUND


Being asleep is an important risk factor for death during a residential fire; however, the high-frequency tone smoke alarms in many homes will not adequately awaken children who are old enough to self-rescue. In a series of previous studies, we identified smoke alarm signals that effectively awaken children 5-12 years old and prompt their escape. Because it is impractical to have separate alarms for children and adults in a household, the purpose of this study is to test whether alarms that are effective in awakening children and prompting their escape are also effective among adults.
METHODS


Using a randomized, non-blinded, repeated measures design, 150 adults 20-49 years old were exposed during stage 4 sleep to four different smoke alarms. Statistical tests included the Kaplan-Meier estimator, generalized Wilcoxon test, and hazard ratios with Wald's 95% confidence intervals.
RESULTS


The median age of study subjects was 30.0 years and 67.3% were female. Almost all (n = 149) subjects awakened and performed the escape procedure to all four alarms; one individual did not awaken or escape to the high-frequency tone alarm. The median time-to-awaken was 2.0 s for the high-frequency tone alarm and 1.0 s for the other three alarms. The median time-to-escape for the high-frequency tone alarm was 12.0 s, compared with 10.0 s for the low-frequency tone alarm and 9.0 s each for the female and male voice alarms. All pairwise comparisons between the high-frequency tone alarm and each of the other three alarms were statistically significant for the probability functions for time-to-awaken and time-to-escape. There were no significant differences in these outcome measures between the latter three alarms, except for female voice versus low-frequency tone alarms for time-to-escape.
CONCLUSIONS


All alarms performed well, demonstrating that smoke alarms developed for the unique developmental requirements of sleeping children are also effective among sleeping adults. Compared with a high-frequency tone alarm, use of these alarms may reduce residential fire-related injuries and deaths among children, while also successfully alerting adult members of the household.",2020,"There were no significant differences in these outcome measures between the latter three alarms, except for female voice versus low-frequency tone alarms for time-to-escape.
","['The median age of study subjects was 30.0\u2009years and 67.3% were female', '150 adults 20-49\u2009years old were exposed during stage 4 sleep to four different smoke alarms', ""children's smoke alarms for sleeping adults"", 'Optimizing smoke alarm signals']",[],"['Kaplan-Meier estimator, generalized Wilcoxon test, and hazard ratios', 'median time-to-awaken', 'median time-to-escape']","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0336648', 'cui_str': 'Alarm'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}]",[],"[{'cui': 'C0401805', 'cui_str': 'Estimator'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",150.0,0.033668,"There were no significant differences in these outcome measures between the latter three alarms, except for female voice versus low-frequency tone alarms for time-to-escape.
","[{'ForeName': 'Gary A', 'Initials': 'GA', 'LastName': 'Smith', 'Affiliation': ""Center for Injury Research and Policy, The Abigail Wexner Research Institute at Nationwide Children's Hospital, 700 Children's Drive, Columbus, OH, 43205, USA. Gary.Smith@nationwidechildrens.org.""}, {'ForeName': 'Sandhya', 'Initials': 'S', 'LastName': 'Kistamgari', 'Affiliation': ""Center for Injury Research and Policy, The Abigail Wexner Research Institute at Nationwide Children's Hospital, 700 Children's Drive, Columbus, OH, 43205, USA.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Splaingard', 'Affiliation': 'Department of Pediatrics, The Ohio State University College of Medicine, Columbus, OH, USA.'}]",Injury epidemiology,['10.1186/s40621-020-00279-6']
3284,33048477,Impact of Green Tea Catechin Ingestion on the Pharmacokinetics of Lisinopril in Healthy Volunteers.,"Lisinopril, a highly hydrophilic long-acting angiotensin-converting enzyme inhibitor, is frequently prescribed for the treatment of hypertension and congestive heart failure. Green tea consumption may reduce the risk of cardiovascular outcomes and total mortality, whereas green tea or its catechin components has been reported to decrease plasma concentrations of a hydrophilic β blocker, nadolol, in humans. The aim of this study was to evaluate possible effects of green tea extract (GTE) on the lisinopril pharmacokinetics. In an open-label, randomized, single-center, 2-phase crossover study, 10 healthy subjects ingested 200 mL of an aqueous solution of GTE containing ~ 300 mg of (-)-epigallocatechin gallate, a major catechin component in green tea, or water (control) when receiving 10 mg of lisinopril after overnight fasting. The geometric mean ratio (GTE/control) for maximum plasma concentration and the area under the plasma concentration-time curve of lisinopril were 0.289 (90% confidence interval (CI) 0.226-0.352) and 0.337 (90% CI 0.269-0.405), respectively. In contrast, there were no significant differences in time to reach maximum lisinopril concentration (6 hours in both phases) and renal clearance of lisinopril (57.7 mL/minute in control vs. 56.9 mL/minute in GTE). These results suggest that the extent of intestinal absorption of lisinopril was significantly impaired in the presence of GTE, whereas it had no major effect on the absorption rate and renal excretion of lisinopril. Concomitant use of lisinopril and green tea may decrease oral exposure to lisinopril, and therefore result in reduced therapeutic efficacy.",2020,The geometric mean ratio (GTE/control) for maximum plasma concentration and the area under the plasma concentration-time curve of lisinopril were 0.289,"['10 healthy subjects', 'healthy volunteers']","['lisinopril', 'green tea extract (GTE', 'lisinopril and green tea', 'Lisinopril', 'green tea catechin ingestion', 'ingested 200 ml of an aqueous solution of GTE containing approximately 300 mg of (-)-epigallocatechin gallate (EGCG), a major catechin component in green tea, or water (control) when receiving 10 mg of lisinopril']","['risk of cardiovascular outcomes and total mortality', 'time to reach maximum lisinopril concentration', 'geometric mean ratio (GTE/control) for maximum plasma concentration and the area under the plasma concentration-time curve of lisinopril', 'renal clearance', 'absorption rate and renal excretion of lisinopril', 'intestinal absorption of lisinopril']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0065374', 'cui_str': 'Lisinopril'}, {'cui': 'C1704263', 'cui_str': 'Green Tea Extract'}, {'cui': 'C1384640', 'cui_str': 'Green tea'}, {'cui': 'C0007404', 'cui_str': 'Catechin'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0059438', 'cui_str': 'epigallocatechin gallate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0065374', 'cui_str': 'Lisinopril'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1704263', 'cui_str': 'Green Tea Extract'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0232813', 'cui_str': 'Renal clearance'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C1373187', 'cui_str': 'Renal Excretion'}, {'cui': 'C0021826', 'cui_str': 'Intestinal absorption'}]",10.0,0.054676,The geometric mean ratio (GTE/control) for maximum plasma concentration and the area under the plasma concentration-time curve of lisinopril were 0.289,"[{'ForeName': 'Shingen', 'Initials': 'S', 'LastName': 'Misaka', 'Affiliation': 'Department of Bioregulation and Pharmacological Medicine, School of Medicine, Fukushima Medical University School of Medicine, Fukushima, Japan.'}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Ono', 'Affiliation': 'Department of Bioregulation and Pharmacological Medicine, School of Medicine, Fukushima Medical University School of Medicine, Fukushima, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Uchida', 'Affiliation': 'Department of Pharmacy, University of Yamanashi Hospital, Chuo-city, Japan.'}, {'ForeName': 'Tomoyuki', 'Initials': 'T', 'LastName': 'Ono', 'Affiliation': 'Department of Bioregulation and Pharmacological Medicine, School of Medicine, Fukushima Medical University School of Medicine, Fukushima, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Abe', 'Affiliation': 'Department of Bioregulation and Pharmacological Medicine, School of Medicine, Fukushima Medical University School of Medicine, Fukushima, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Ogata', 'Affiliation': 'Department of Bioregulation and Pharmacological Medicine, School of Medicine, Fukushima Medical University School of Medicine, Fukushima, Japan.'}, {'ForeName': 'Hideyuki', 'Initials': 'H', 'LastName': 'Sato', 'Affiliation': 'Laboratory of Biopharmacy, School of Pharmaceutical Sciences, University of Shizuoka, Suruga-ku, Japan.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Suzuki', 'Affiliation': 'Department of Pharmacy, University of Yamanashi Hospital, Chuo-city, Japan.'}, {'ForeName': 'Satomi', 'Initials': 'S', 'LastName': 'Onoue', 'Affiliation': 'Laboratory of Biopharmacy, School of Pharmaceutical Sciences, University of Shizuoka, Suruga-ku, Japan.'}, {'ForeName': 'Yayoi', 'Initials': 'Y', 'LastName': 'Shikama', 'Affiliation': 'Center for Medical Education and Career Development, Fukushima Medical University, Fukushima, Japan.'}, {'ForeName': 'Kenju', 'Initials': 'K', 'LastName': 'Shimomura', 'Affiliation': 'Department of Bioregulation and Pharmacological Medicine, School of Medicine, Fukushima Medical University School of Medicine, Fukushima, Japan.'}]",Clinical and translational science,['10.1111/cts.12905']
3285,33045195,Circulating profile of Activin-Follistatin-Inhibin Axis in women with hypothalamic amenorrhea in response to leptin treatment.,"BACKGROUND


Chronic energy deficiency observed in women that exercise strenuously affects reproductive function, often leading to hypothalamic amenorrhea (HA). In such conditions, hypoleptinemia and robust changes in the Activin-Follistatin-Inhibin Axis (AFI) are observed. Treatment with leptin restores menstruation in many (60% responders) but not all (40% non-responders) women, suggesting that leptin is not the only regulator of reproductive function related to energy balance. In this work, we aimed to identify differences in hormonal profiles between leptin responders and non-responders among women with HA, with particular focus on the AFI axis.
METHODS


AFI axis and reproductive hormones (LH, FSH, Estradiol, ΑΜΗ) were measured in blood in: a) An open-label interventional study, b) a randomized placebo-controlled trial, both investigating responders versus non-responders/women with HA treated with leptin.
RESULTS


Women with HA that responded to leptin treatment have higher circulating levels/peak values of Inhibin A, Estradiol (E2), higher LH/FSH ratio and a trend to lower AMH compared with non-responders.
CONCLUSIONS


Components of the AFI axis are associated with improvement of reproductive function in women with HA treated with leptin. ΑΜΗ may serve as a marker of ovarian recovery under HA treatment.",2020,"Treatment with leptin restores menstruation in many (60% responders) but not all (40% non-responders) women, suggesting that leptin is not the only regulator of reproductive function related to energy balance.","['women with HA, with particular focus on the AFI axis', 'responders versus non-responders/women with HA treated with leptin', 'women with HA treated with leptin', 'women with hypothalamic amenorrhea in response to leptin treatment']",['placebo'],"['circulating levels/peak values of Inhibin A, Estradiol (E2), higher LH/FSH ratio', 'reproductive function', 'AFI axis and reproductive hormones (LH, FSH, Estradiol, ΑΜΗ']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0341862', 'cui_str': 'Hypothalamic amenorrhea'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0883157', 'cui_str': 'Inhibin A'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0202022', 'cui_str': 'Follicle stimulating hormone measurement'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0232896', 'cui_str': 'Reproductive function'}, {'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}, {'cui': 'C1167871', 'cui_str': 'Reproductive hormone'}]",,0.0378645,"Treatment with leptin restores menstruation in many (60% responders) but not all (40% non-responders) women, suggesting that leptin is not the only regulator of reproductive function related to energy balance.","[{'ForeName': 'Eirini', 'Initials': 'E', 'LastName': 'Bouzoni', 'Affiliation': 'Division of Endocrinology, Beth Israel Deaconess Medical Center/Harvard Medical School, Boston, MA, USA. Electronic address: ebouzoni@bidmc.harvard.edu.'}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Perakakis', 'Affiliation': 'Division of Endocrinology, Beth Israel Deaconess Medical Center/Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Christos S', 'Initials': 'CS', 'LastName': 'Mantzoros', 'Affiliation': 'Division of Endocrinology, Beth Israel Deaconess Medical Center/Harvard Medical School, Boston, MA, USA; Section of Endocrinology, VA Boston Healthcare System, Jamaica Plain, MA, USA.'}]",Metabolism: clinical and experimental,['10.1016/j.metabol.2020.154392']
3286,33045290,Catheter Removal on the Same Day of Holmium Laser Enucleation of the Prostate: Outcomes of a Pilot Study.,"OBJECTIVES


To determine if same day catheter removal is feasible in select population after holmium laser enucleation of the prostate (HoLEP).
METHODS


We performed an analysis of patients undergoing HoLEP at our institution who underwent same-day catheter removal after HoLEP. All HoLEPs were performed with Moses Optimized for BPH. Patients were dismissed from postoperative recovery unit (POCU) to the clinic for catheter removal and voiding trial.
RESULTS


To date, 30 patients have undergone same day catheter removal. Median age is 68.6 years (IQR 61.8-73.3) and preoperative prostate volume 81 ml (IQR 53-114.8). Median enucleation time was 39.5 min (IQR 30.5-53), morcellation time was 5 min (IQR 4-12 min) and enucleated specimen weight was 52.5 g (IQR 33-81).  27 (90%) patients successfully voided on the same day without requiring catheter replacement. All patients were catheter free by POD1. For patients who successfully passed their voiding trial, the median time from the end of the procedure to hospital discharge was 2.6 hours (IQR (2.1-2.9) and from the end of the HoLEP to catheter removal was 4.9 hours (IQR 3.5-6.0).
CONCLUSIONS


We present for the first time that same day catheter removal is a feasible option in a select population of patients undergoing HoLEP. With more study, this has the potential for transforming the management of BPH, especially larger glands.",2020,"Median enucleation time was 39.5 min (IQR 30.5-53), morcellation time was 5 min (IQR 4-12 min) and enucleated specimen weight was 52.5 g (IQR 33-81).  ","['patients undergoing HoLEP at our institution who underwent same-day catheter removal after HoLEP', 'patients undergoing HoLEP', '30 patients have undergone same day catheter removal', 'select population after holmium laser enucleation of the prostate (HoLEP']",['Holmium Laser Enucleation'],"['hospital discharge', 'morcellation time', 'enucleated specimen weight', 'HoLEP to catheter removal', 'Median enucleation time']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441085', 'cui_str': 'Holmium:YAG laser device'}, {'cui': 'C0014392', 'cui_str': 'Enucleation'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0036002', 'cui_str': 'S-Adenosylmethionine'}, {'cui': 'C0394884', 'cui_str': 'Removal of catheter'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0441085', 'cui_str': 'Holmium:YAG laser device'}, {'cui': 'C0014392', 'cui_str': 'Enucleation'}]","[{'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C4042900', 'cui_str': 'Morcellation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0441085', 'cui_str': 'Holmium:YAG laser device'}, {'cui': 'C0014392', 'cui_str': 'Enucleation'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0394884', 'cui_str': 'Removal of catheter'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",,0.0546925,"Median enucleation time was 39.5 min (IQR 30.5-53), morcellation time was 5 min (IQR 4-12 min) and enucleated specimen weight was 52.5 g (IQR 33-81).  ","[{'ForeName': 'Deepak K', 'Initials': 'DK', 'LastName': 'Agarwal', 'Affiliation': 'Department of Urology, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Marcelino E', 'Initials': 'ME', 'LastName': 'Rivera', 'Affiliation': 'Department of Urology, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Charles U', 'Initials': 'CU', 'LastName': 'Nottingham', 'Affiliation': 'Department of Urology, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Large', 'Affiliation': 'Department of Urology, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Amy E', 'Initials': 'AE', 'LastName': 'Krambeck', 'Affiliation': 'Department of Urology, Indiana University School of Medicine, Indianapolis, IN. Electronic address: akrambeck@iuhealth.org.'}]",Urology,['10.1016/j.urology.2020.09.038']
3287,33046009,Feasibility of a yoga intervention to decrease pain in older women: a randomized controlled pilot study.,"BACKGROUND


A significant proportion of older women suffer from chronic pain, which can decrease quality of life. The objective of this pilot randomized study was to evaluate the feasibility of a flow-restorative yoga intervention designed to decrease pain and related outcomes among women aged 60 or older.
METHODS


Flow-restorative yoga classes were held twice weekly for 1 hour and led by a certified yoga instructor. Participants randomized to the intervention group attended the yoga classes for 12 weeks and received supplemental materials for at-home practice. Those randomized to the control group were asked to maintain their normal daily routine. Feasibility was evaluated using recruitment and retention rates, class and home practice adherence rates, and participant satisfaction surveys. Outcome measures (self-reported pain, inflammatory markers, functional fitness, quality of life, resilience, and self-reported physical activity) were assessed at baseline and post-intervention. Paired t-tests or Wilcoxon signed-rank tests were used to examine changes in outcome measures within treatment groups.
RESULTS


Thirty-eight participants were recruited and randomized. Participants were primarily white, college-educated, and higher functioning, despite experiencing various forms of chronic pain. Attendance and retention rates were high (91 and 97%, respectively) and the majority of participants were satisfied with the yoga program (89%) and would recommend it to others (87%). Intervention participants also experienced reductions in pain interference and improvements in energy and social functioning.
CONCLUSIONS


This pilot study provides essential data to inform a full scale randomized trial of flow-restorative yoga for older women with chronic pain. Future studies should emphasize strategies to recruit a more diverse study population, particularly older women at higher risk of disability and functional decline.
TRIAL REGISTRATION


Clinicaltrials.gov , NCT03790098 . Registered 31 December 2018 - Retrospectively registered.",2020,"Attendance and retention rates were high (91 and 97%, respectively) and the majority of participants were satisfied with the yoga program (89%) and would recommend it to others (87%).","['older women suffer from chronic pain', 'older women', 'women aged 60 or older', 'Participants were primarily white, college-educated, and higher functioning, despite experiencing various forms of chronic pain', 'Thirty-eight participants were recruited and randomized', 'older women with chronic pain', 'Registered 31 December 2018 - Retrospectively registered']","['flow-restorative yoga intervention', 'flow-restorative yoga', 'yoga intervention']","['pain interference and improvements in energy and social functioning', 'recruitment and retention rates, class and home practice adherence rates, and participant satisfaction surveys', 'Outcome measures (self-reported pain, inflammatory markers, functional fitness, quality of life, resilience, and self-reported physical activity', 'Attendance and retention rates', 'pain']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0450361', 'cui_str': '38'}, {'cui': 'C0600375', 'cui_str': 'Registers'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}]",38.0,0.162826,"Attendance and retention rates were high (91 and 97%, respectively) and the majority of participants were satisfied with the yoga program (89%) and would recommend it to others (87%).","[{'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Seguin-Fowler', 'Affiliation': 'Texas A&M AgriLife Research, 600 John Kimborough Boulevard, Suite 512, College Station, TX, USA. r.seguin-fowler@ag.tamu.edu.'}, {'ForeName': 'Meredith', 'Initials': 'M', 'LastName': 'Graham', 'Affiliation': 'Texas A&M University System, 600 John Kimborough Boulevard, Suite 512, College Station, TX, USA.'}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Ward', 'Affiliation': 'Cornell University, 413 Savage Hall, Ithaca, NY, 14853, USA.'}, {'ForeName': 'Galen', 'Initials': 'G', 'LastName': 'Eldridge', 'Affiliation': 'Texas A&M AgriLife Research, 600 John Kimborough Boulevard, Suite 512, College Station, TX, USA.'}, {'ForeName': 'Urshila', 'Initials': 'U', 'LastName': 'Sriram', 'Affiliation': 'Texas A&M AgriLife Research, 600 John Kimborough Boulevard, Suite 512, College Station, TX, USA.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Fine', 'Affiliation': 'Fine Spirit Yoga, 104 E. Lewis St, Ithaca, NY, 14850, USA.'}]",BMC geriatrics,['10.1186/s12877-020-01818-y']
3288,33046026,"Study protocol: parents as pain management in Swedish neonatal care - SWEpap, a multi-center randomized controlled trial.","BACKGROUND


During the first period of life, critically ill as well as healthy newborn infants experience recurrent painful procedures. Parents are a valuable but often overlooked resource in procedural pain management in newborns. Interventions to improve parents' knowledge and involvement in infants' pain management are essential to implement in the care of the newborn infant. Neonatal pain research has studied a range of non-pharmacological pain alleviating strategies during painful procedures, yet, regarding combined multisensorial parent-driven non-pharmacological pain management, research is still lacking.
METHODS/DESIGN


A multi-center randomized controlled trial (RCT) with three parallel groups with the allocation ratio 1:1:1 is planned. The RCT ""Parents as pain management in Swedish neonatal care - SWEpap"", will investigate the efficacy of combined pain management with skin-to-skin contact, breastfeeding and live parental lullaby singing compared with standard pain care initiated by health care professionals, during routine metabolic screening of newborn infants (PKU-test).
DISCUSSION


Parental involvement in neonatal pain management enables a range of comforting parental interventions such as skin-to-skin contact, breastfeeding, rocking and soothing vocalizations. To date, few studies have been published examining the efficacy of combined multisensorial parent-driven interventions. So far, research shows that the use of combined parent-driven pain management such as skin-to-skin contact and breastfeeding, is more effective in reducing behavioral responses to pain in infants, than using the pain-relieving interventions alone. Combined parental soothing behaviors that provide rhythmic (holding/rocking/vocalizing) or orogustatory/orotactile (feeding/pacifying) stimulation that keep the parent close to the infant, are more effective in a painful context. In the SWEpap study we also include parental live lullaby singing, which is an unexplored but promising biopsychosocial, multimodal and multisensory pain alleviating adjuvant, especially in combination with skin-to-skin contact and breastfeeding.
TRIAL REGISTRATION


ClinicalTrials.gov ( NCT04341194 ) 10 April 2020.",2020,Interventions to improve parents' knowledge and involvement in infants' pain management are essential to implement in the care of the newborn infant.,"['newborns', 'healthy newborn infants experience recurrent painful procedures']",['Combined parental soothing behaviors that provide rhythmic (holding/rocking/vocalizing) or orogustatory/orotactile (feeding/pacifying) stimulation'],[],"[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0578757', 'cui_str': 'Good neonatal condition at birth'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0005899', 'cui_str': 'Repetitive rocking movements'}, {'cui': 'C0564182', 'cui_str': 'Vocalization'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]",[],,0.0632619,Interventions to improve parents' knowledge and involvement in infants' pain management are essential to implement in the care of the newborn infant.,"[{'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Olsson', 'Affiliation': 'Faculty of Medicine and Health, School of Health Sciences, Örebro University, S-701 82, Örebro, Sweden. emma.olsson@oru.se.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Carlsen Misic', 'Affiliation': 'Faculty of Medicine and Health, School of Health Sciences, Örebro University, S-701 82, Örebro, Sweden.'}, {'ForeName': 'Randi', 'Initials': 'R', 'LastName': 'Dovland Andersen', 'Affiliation': 'Department of Research, Telemark Hospital Trust, Skien, Norway.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Ericson', 'Affiliation': 'School of Education, Health and Social Studies, Dalarna University, Falun, Sweden.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Eriksson', 'Affiliation': 'Faculty of Medicine and Health, School of Health Sciences, Örebro University, S-701 82, Örebro, Sweden.'}, {'ForeName': 'Ylva', 'Initials': 'Y', 'LastName': 'Thernström Blomqvist', 'Affiliation': 'Neonatal Intensive Care Unit, University Hospital, Uppsala, Sweden.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Ullsten', 'Affiliation': 'Faculty of Medicine and Health, School of Health Sciences, Örebro University, S-701 82, Örebro, Sweden.'}]",BMC pediatrics,['10.1186/s12887-020-02356-7']
3289,33046053,Bone turnover biomarkers in COPD patients randomized to either a regular or shortened course of corticosteroids: a substudy of the randomized controlled CORTICO-COP trial.,"BACKGROUND


Long-term treatment with corticosteroids causes loss of bone density, but the effects of using short-term high-dose systemic-corticosteroid therapy to treat acute exacerbations of chronic obstructive pulmonary disease (AECOPD) are unclear. Our aim was to determine whether high-dose corticosteroid therapy affected bone turnover markers (BTMs) to a greater extent compared to low-dose corticosteroid therapy.
METHODS


The CORTICO-COP trial (NCT02857842) showed that an eosinophil-guided corticosteroid intervention led to approximately 60% lower accumulated corticosteroid dose for hospitalized patients with AECOPD (low-dose group) compared with 5-day standard corticosteroid treatment (high-dose group). We compared the levels of BTMs C-terminal telopeptide of type 1 collagen (CTX) and procollagen type 1 N-terminal propeptide (P1NP) in 318 participants during AECOPD and at 1- and 3-month follow-up visits.
RESULTS


CTX decreased and P1NP increased significantly over time in both treatment groups. There were no significant differences between the groups at 1- or 3-months follow-up for P1NP. A significant drop in CTX was seen at 3 months (down Δ24% from the baseline, p = 0.017) for the high dose group.
CONCLUSION


Short-term, high-dose systemic corticosteroid treatment caused a rapid suppression of biomarkers of bone resorption. Corticosteroids did not suppress biomarkers of bone formation, regardless of patients receiving low or high doses of corticosteroids. This therapy was, therefore, harmless in terms of bone safety, in our prospective series of COPD patients.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT02857842 . Submitted August 2nd, 2016.",2020,"A significant drop in CTX was seen at 3 months (down Δ24% from the baseline, p = 0.017) for the high dose group.
","['318 participants during AECOPD and at 1- and 3-month follow-up visits', 'COPD patients']","['corticosteroids', 'Corticosteroids']","['CTX', 'levels of BTMs C-terminal telopeptide of type 1 collagen (CTX) and procollagen type 1\u2009N-terminal propeptide (P1NP', 'rapid suppression of biomarkers of bone resorption', 'bone formation', 'Bone turnover biomarkers', 'P1NP', 'bone turnover markers (BTMs']","[{'cui': 'C0340044', 'cui_str': 'Acute exacerbation of chronic obstructive airways disease'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589121', 'cui_str': 'Follow-up visit'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]","[{'cui': 'C0010377', 'cui_str': 'Crotoxin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0041455', 'cui_str': 'Collagen Type I'}, {'cui': 'C0033235', 'cui_str': 'Procollagen'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0005974', 'cui_str': 'Bone resorption'}, {'cui': 'C0029433', 'cui_str': 'Bone formation'}]",,0.319295,"A significant drop in CTX was seen at 3 months (down Δ24% from the baseline, p = 0.017) for the high dose group.
","[{'ForeName': 'Pradeesh', 'Initials': 'P', 'LastName': 'Sivapalan', 'Affiliation': 'Section of Respiratory Medicine, Department of Medicine, Herlev and Gentofte Hospital, University of Copenhagen, Gentofte Hospitalsvej 7, Ground Floor, DK-2900, Hellerup, Denmark. pradeesh.s@dadlnet.dk.'}, {'ForeName': 'Niklas R', 'Initials': 'NR', 'LastName': 'Jørgensen', 'Affiliation': 'Department of Clinical Biochemistry, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Alexander G', 'Initials': 'AG', 'LastName': 'Mathioudakis', 'Affiliation': 'The North West Lung Centre, Wythenshawe Hospital, Manchester University NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Josefin', 'Initials': 'J', 'LastName': 'Eklöf', 'Affiliation': 'Section of Respiratory Medicine, Department of Medicine, Herlev and Gentofte Hospital, University of Copenhagen, Gentofte Hospitalsvej 7, Ground Floor, DK-2900, Hellerup, Denmark.'}, {'ForeName': 'Therese', 'Initials': 'T', 'LastName': 'Lapperre', 'Affiliation': 'Department of Respiratory Medicine, Bispebjerg University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Charlotte Suppli', 'Initials': 'CS', 'LastName': 'Ulrik', 'Affiliation': 'Department of Respiratory Medicine, Amager and Hvidovre University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Helle F', 'Initials': 'HF', 'LastName': 'Andreassen', 'Affiliation': 'Department of Respiratory Medicine, Bispebjerg University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Armbruster', 'Affiliation': 'Section of Respiratory Medicine, Department of Medicine, Herlev and Gentofte Hospital, University of Copenhagen, Gentofte Hospitalsvej 7, Ground Floor, DK-2900, Hellerup, Denmark.'}, {'ForeName': 'Praleene', 'Initials': 'P', 'LastName': 'Sivapalan', 'Affiliation': 'Section of Respiratory Medicine, Department of Medicine, Herlev and Gentofte Hospital, University of Copenhagen, Gentofte Hospitalsvej 7, Ground Floor, DK-2900, Hellerup, Denmark.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Janner', 'Affiliation': 'Department of Respiratory Medicine, Bispebjerg University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Godtfredsen', 'Affiliation': 'Department of Respiratory Medicine, Amager and Hvidovre University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Ulla M', 'Initials': 'UM', 'LastName': 'Weinreich', 'Affiliation': 'Department of Respiratory Diseases, Aalborg University Hospital, Aalborg, Denmark; The Clinical Institute, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Thyge L', 'Initials': 'TL', 'LastName': 'Nielsen', 'Affiliation': 'Department of Respiratory and Infectious Diseases, Frederiksund and Hillerød Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Seersholm', 'Affiliation': 'Section of Respiratory Medicine, Department of Medicine, Herlev and Gentofte Hospital, University of Copenhagen, Gentofte Hospitalsvej 7, Ground Floor, DK-2900, Hellerup, Denmark.'}, {'ForeName': 'Torgny', 'Initials': 'T', 'LastName': 'Wilcke', 'Affiliation': 'Section of Respiratory Medicine, Department of Medicine, Herlev and Gentofte Hospital, University of Copenhagen, Gentofte Hospitalsvej 7, Ground Floor, DK-2900, Hellerup, Denmark.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Schuetz', 'Affiliation': 'Medical University Department, Kantonsspital Aarau, 5001, Aarau, Switzerland.'}, {'ForeName': 'Tobias W', 'Initials': 'TW', 'LastName': 'Klausen', 'Affiliation': 'Clinical Research Unit, Department of Hematology, Herlev Hospital, Herlev, Denmark.'}, {'ForeName': 'Kristoffer', 'Initials': 'K', 'LastName': 'Marså', 'Affiliation': 'Palliative Medicine Section Unit, Herlev and Gentofte Hospital, Herlev, Denmark.'}, {'ForeName': 'Jørgen', 'Initials': 'J', 'LastName': 'Vestbo', 'Affiliation': 'The North West Lung Centre, Wythenshawe Hospital, Manchester University NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Jens-Ulrik', 'Initials': 'JU', 'LastName': 'Jensen', 'Affiliation': 'Section of Respiratory Medicine, Department of Medicine, Herlev and Gentofte Hospital, University of Copenhagen, Gentofte Hospitalsvej 7, Ground Floor, DK-2900, Hellerup, Denmark.'}]",Respiratory research,['10.1186/s12931-020-01531-9']
3290,33046070,Blood pressure and mortality in patients with type 2 diabetes and a recent coronary event in the ELIXA trial.,"BACKGROUND


The relationship between blood pressure and mortality in type 2 diabetes (T2DM) is controversial, with concern for increased risk associated with excessively lowered blood pressure.
METHODS


We evaluated whether prior cardiovascular disease (CVD) altered the relationship between baseline blood pressure and all-cause mortality in 5852 patients with T2DM and a recent acute coronary syndrome (ACS) who participated in the ELIXA (Evaluation of Lixisenatide in Acute Coronary Syndrome) trial. Risk of death was assessed in Cox models adjusted for age, sex, race, heart rate, BMI, smoking, diabetes duration, insulin use, HbA1c, eGFR, brain natriuretic peptide (BNP), urine albumin/creatinine ratio, treatment allocation and prior coronary revascularization.
RESULTS


Although overall there was no significant association between systolic blood pressure (SBP) and mortality (hazard ratio per 10 mmHg lower SBP 1.05 (95% CI 0.99-1.12) P = 0.10), lower SBP was significantly associated with higher risk of death (hazard ratio per 10 mmHg lower SBP 1.13 (95% CI 1.04-1.22) P = 0.002) in 2325 patients with additional CVD (index ACS+ at least one of the following prior to randomization: myocardial infarction other than the index ACS, stroke or heart failure). In 3527 patients with only the index ACS no significant association was observed (hazard ratio per 10 mmHg lower SBP 0.95 (0.86-1.04) P = 0.26; P for interaction 0.005).
CONCLUSIONS


The association between blood pressure and mortality was modified by additional CVD history in patients with type 2 diabetes and a recent coronary event. When blood pressures measured after an acute coronary event are used to assess the risk of death in patients with type 2 diabetes, the cardiovascular history needs to be taken into consideration. Trial registration ClinicalTrials.gov number NCT01147250, first posted June 22, 2010.",2020,"Although overall there was no significant association between systolic blood pressure (SBP) and mortality (hazard ratio per 10 mmHg lower SBP 1.05 (95% CI 0.99-1.12) P = 0.10), lower SBP was significantly associated with higher risk of death (hazard ratio per 10 ","['patients with type 2 diabetes and a recent coronary event', 'patients with type 2 diabetes and a recent coronary event in the ELIXA trial', 'patients with type 2 diabetes', '2325 patients with additional CVD (index ACS+\u2009at least one of the following prior to randomization: myocardial infarction other than the index ACS, stroke or heart failure', '5852 patients with T2DM and a recent acute coronary syndrome (ACS) who participated in the ELIXA (Evaluation of Lixisenatide in Acute Coronary Syndrome) trial']",[],"['blood pressure and mortality', 'risk of death', 'Risk of death', 'lower SBP', 'systolic blood pressure (SBP) and mortality', 'heart rate, BMI, smoking, diabetes duration, insulin use, HbA1c, eGFR, brain natriuretic peptide (BNP), urine albumin/creatinine ratio, treatment allocation and prior coronary revascularization', 'Blood pressure and mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C2973895', 'cui_str': 'Lixisenatide'}]",[],"[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0277885', 'cui_str': 'Decreased systolic arterial pressure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0240016', 'cui_str': 'Insulin used'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0455271', 'cui_str': 'Urine albumin/creatinine ratio measurement'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}]",2325.0,0.0660196,"Although overall there was no significant association between systolic blood pressure (SBP) and mortality (hazard ratio per 10 mmHg lower SBP 1.05 (95% CI 0.99-1.12) P = 0.10), lower SBP was significantly associated with higher risk of death (hazard ratio per 10 ","[{'ForeName': 'Magnus O', 'Initials': 'MO', 'LastName': 'Wijkman', 'Affiliation': ""Cardiovascular Division, Brigham & Women's Hospital, Harvard Medical School, 75 Francis Street, Boston, MA, 02115, USA. mwijkman@bwh.harvard.edu.""}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Claggett', 'Affiliation': ""Cardiovascular Division, Brigham & Women's Hospital, Harvard Medical School, 75 Francis Street, Boston, MA, 02115, USA.""}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Diaz', 'Affiliation': 'Estudios Clínicos Latinoamérica, Instituto Cardiovascular de Rosario, Rosario, Argentina.'}, {'ForeName': 'Hertzel C', 'Initials': 'HC', 'LastName': 'Gerstein', 'Affiliation': 'The Population Health Research Institute and the Department of Medicine, McMaster University and Hamilton Health Sciences, Hamilton, Canada.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Køber', 'Affiliation': 'Rigshospitalet Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Eldrin', 'Initials': 'E', 'LastName': 'Lewis', 'Affiliation': 'Stanford University Medical Center, Stanford, USA.'}, {'ForeName': 'Aldo P', 'Initials': 'AP', 'LastName': 'Maggioni', 'Affiliation': 'Maria Cecilia Hospital, GVM Care & Research, Cotignola, Italy.'}, {'ForeName': 'Emil', 'Initials': 'E', 'LastName': 'Wolsk', 'Affiliation': 'Rigshospitalet Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Aguilar', 'Affiliation': 'McGovern Medical School, University of Texas, Houston, USA.'}, {'ForeName': 'Rhonda', 'Initials': 'R', 'LastName': 'Bentley-Lewis', 'Affiliation': 'Massachusetts General Hospital, Harvard Medical School, Boston, USA.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'McMurray', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Probstfield', 'Affiliation': 'University of Washington Medical Center, Seattle, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Riddle', 'Affiliation': 'Oregon Health and Science University, Portland, USA.'}, {'ForeName': 'Jean-Claude', 'Initials': 'JC', 'LastName': 'Tardif', 'Affiliation': 'Montreal Heart Institute, Université de Montréal, Montreal, Canada.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Cardiovascular Division, Brigham & Women's Hospital, Harvard Medical School, 75 Francis Street, Boston, MA, 02115, USA.""}, {'ForeName': 'Marc A', 'Initials': 'MA', 'LastName': 'Pfeffer', 'Affiliation': ""Cardiovascular Division, Brigham & Women's Hospital, Harvard Medical School, 75 Francis Street, Boston, MA, 02115, USA.""}]",Cardiovascular diabetology,['10.1186/s12933-020-01150-0']
3291,33049709,Effects of estradiol on biological age measured using the glycan age index.,"Glycan age is a recently developed biomarker based on glycans attached to immunoglobulin G (IgG). In large population cohorts, glycan age associates well with lifestyle and disease-risk biomarkers, while some studies suggested that glycan changes precede development of several age-associated diseases. In this study we evaluated effects of estrogen on the glycan age. Gonadal hormones were suppressed in 36 healthy young women by gonadotropin releasing hormone agonist therapy for 6 months. In 15 of them estradiol was supplemented, while 21 received placebo resulting in very low estrogen levels during intervention. IgG was isolated from plasma samples before intervention, after 6 months of intervention and after subsequent 4-month recovery. Deprivation of gonadal hormones resulted in median increase of glycan age for 9.1 years (IQR 6.8 - 11.5 years, p = 3.73×10 -8 ), which was completely prevented by transdermal estradiol therapy (change in glycan age = -0.23 years, IQR (-2.20 - 2.98). After the recovery period glycan age returned to baseline values in both groups. These results suggest that IgG glycans and consequently also the glycan age are under strong influence of gonadal hormones and that estradiol therapy can prevent the increase of glycan age that occurs in the perimenopausal period.",2020,After the recovery period glycan age returned to baseline values in both groups.,['36 healthy young women by'],"['gonadotropin releasing hormone agonist therapy', 'estradiol', 'placebo']",[],"[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C1518041', 'cui_str': 'Gonadotropin releasing hormone analogues'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],36.0,0.0226459,After the recovery period glycan age returned to baseline values in both groups.,"[{'ForeName': 'Julija', 'Initials': 'J', 'LastName': 'Jurić', 'Affiliation': 'Genos Glycoscience Research Laboratory, Zagreb, Croatia.'}, {'ForeName': 'Wendy M', 'Initials': 'WM', 'LastName': 'Kohrt', 'Affiliation': 'Division of Geriatric Medicine, School of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO 80045, USA.'}, {'ForeName': 'Domagoj', 'Initials': 'D', 'LastName': 'Kifer', 'Affiliation': 'Department of Biochemistry and Molecular Biology, Faculty of Pharmacy and Biochemistry, University of Zagreb, Zagreb, Croatia.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Gavin', 'Affiliation': 'Division of Geriatric Medicine, School of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO 80045, USA.'}, {'ForeName': 'Marija', 'Initials': 'M', 'LastName': 'Pezer', 'Affiliation': 'Genos Glycoscience Research Laboratory, Zagreb, Croatia.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Nigrovic', 'Affiliation': 'Division of Rheumatology, Inflammation, and Immunity, Brigham and Women&#xB4;s Hospital, Boston, MA 02115, USA.'}, {'ForeName': 'Gordan', 'Initials': 'G', 'LastName': 'Lauc', 'Affiliation': 'Genos Glycoscience Research Laboratory, Zagreb, Croatia.'}]",Aging,['10.18632/aging.104060']
3292,33052903,Validation of the Unesp-Botucatu composite scale to assess acute postoperative abdominal pain in sheep (USAPS).,"A scale with robust statistical validation is essential to diagnose pain and improve decision making for analgesia. This blind, randomised, prospective and opportunist study aimed to develop an ethogram to evaluate behaviour and validate a scale to assess acute ovine postoperative pain. Elective laparoscopy was performed in 48 healthy sheep, filmed at one preoperative and three postoperative moments, before and after rescue analgesia and 24 hours after. The videos were randomised and assessed twice by four evaluators, with a one-month interval between evaluations. Statistical analysis was performed using R software and differences were considered significant when p <0.05. Based on the multiple association, a unidimensional scale was adopted. The intra- and inter-observer reliability ranged from moderate to very good (intraclass correlation coefficient ≥ 0.53). The scale presented Spearman correlations > 0.80 with the numerical, simple descriptive, and visual analogue scales, and a correlation of 0.48 with the facial expression scale. According to the mixed linear model, the scale was responsive, due to the increase and decrease in pain scores of all items after surgery and analgesic intervention, respectively. All items on the scale demonstrated an acceptable Spearman item-total correlation (0.56-0.76), except for appetite (0.25). The internal consistency was excellent (Cronbach's α = 0.81) and all items presented specificity > 0.72 and sensitivity between 0.61-0.90, except for appetite. According to the Youden index, the cut-off point was ≥ 4 out of 12, with a diagnostic uncertainty zone of 4 to 5. The area under the curve > 0.95 demonstrated the excellent discriminatory capacity of the instrument. In conclusion, the Unesp-Botucatu pain scale in sheep submitted to laparoscopy is valid, reliable, specific, sensitive, with excellent internal consistency, accuracy, discriminatory capacity, and a defined cut-off point.",2020,The intra- and inter-observer reliability ranged from moderate to very good (intraclass correlation coefficient ≥ 0.53).,"['48 healthy sheep', 'sheep (USAPS']",['Elective laparoscopy'],"['Unesp-Botucatu pain scale', 'facial expression scale', 'pain scores']","[{'cui': 'C0036945', 'cui_str': 'Genus Ovis'}]","[{'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}]","[{'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",48.0,0.0194405,The intra- and inter-observer reliability ranged from moderate to very good (intraclass correlation coefficient ≥ 0.53).,"[{'ForeName': 'Nuno Emanuel Oliveira Figueiredo', 'Initials': 'NEOF', 'LastName': 'Silva', 'Affiliation': 'Department of Veterinary Surgery and Animal Reproduction, School of Veterinary Medicine and Animal Science, São Paulo State University (Unesp), Botucatu, São Paulo, Brazil.'}, {'ForeName': 'Pedro Henrique Esteves', 'Initials': 'PHE', 'LastName': 'Trindade', 'Affiliation': 'Department of Veterinary Surgery and Animal Reproduction, School of Veterinary Medicine and Animal Science, São Paulo State University (Unesp), Botucatu, São Paulo, Brazil.'}, {'ForeName': 'Alice Rodrigues', 'Initials': 'AR', 'LastName': 'Oliveira', 'Affiliation': 'Department of Veterinary Surgery and Animal Reproduction, School of Veterinary Medicine and Animal Science, São Paulo State University (Unesp), Botucatu, São Paulo, Brazil.'}, {'ForeName': 'Marilda Onghero', 'Initials': 'MO', 'LastName': 'Taffarel', 'Affiliation': 'Department of Veterinary Medicine, State University of Maringá, Umuarama, Paraná, Brazil.'}, {'ForeName': 'Maria Alice Pires', 'Initials': 'MAP', 'LastName': 'Moreira', 'Affiliation': 'Goiano Federal Institute, Urutaí Campus, Department of Veterinary Medicine, Urutaí, GO, Brazil.'}, {'ForeName': 'Renan', 'Initials': 'R', 'LastName': 'Denadai', 'Affiliation': 'Department of Veterinary Surgery and Animal Reproduction, School of Veterinary Medicine and Animal Science, São Paulo State University (Unesp), Botucatu, São Paulo, Brazil.'}, {'ForeName': 'Paula Barreto', 'Initials': 'PB', 'LastName': 'Rocha', 'Affiliation': 'Department of Veterinary Surgery and Animal Reproduction, School of Veterinary Medicine and Animal Science, São Paulo State University (Unesp), Botucatu, São Paulo, Brazil.'}, {'ForeName': 'Stelio Pacca Loureiro', 'Initials': 'SPL', 'LastName': 'Luna', 'Affiliation': 'Department of Veterinary Surgery and Animal Reproduction, School of Veterinary Medicine and Animal Science, São Paulo State University (Unesp), Botucatu, São Paulo, Brazil.'}]",PloS one,['10.1371/journal.pone.0239622']
3293,33040465,Effects of vitamin D and calcium supplementation on bone mineral density among Thai youth using daily HIV pre-exposure prophylaxis.,"INTRODUCTION


Tenofovir disoproxil fumarate with emtricitabine (TDF/FTC) is used for HIV pre-exposure prophylaxis (PrEP). TDF may affect bone mineral density (BMD), particularly in youth who are at a stage of peak bone mass accrual. The objective of this study was to evaluate the effect of vitamin D and calcium supplementation on BMD among Thai youth receiving daily oral PrEP.
METHODS


This open-label randomized trial was conducted in male youth aged between 15 and 24 years. Participants were randomized to Arm A who received once-daily TDF/FTC plus vitamin D3 and calcium supplementation with meals twice daily (400 units of vitamin D3 and 1200 mg of elemental calcium/day) or Arm B who received once-daily TDF/FTC only. PrEP users were defined as taking at least two tablets/week (tenofovir-diphosphate level of >350 fmol/punch). Adherence to vitamin D/calcium supplementation was defined as self-reported adherence of >50%. Lumbar spine (L2-L4) BMD (LSBMD) was evaluated by dual-energy X-ray absorptiometry scan zero and six months after PrEP initiation.
RESULTS


From March 2019 to March 2020, 100 youth were enrolled. Baseline characteristics between the two arms were similar. Median (IQR) age was 18 (17 to 20) years. At entry, median (IQR) LSBMD z-score was -0.8 (-1.5 to -0.3), 17% had low LSBMD (Z-score < -2). The median amount of calcium intake from nutritional three-day recall was 167 (IQR 94 to 272) mg/day, 39% of participants had vitamin D deficiency, defined as 25(OH)D levels <20 IU/mL. At six months, 79 participants were evaluated. Of these, 42 (52%) were PrEP takers and 25 of 38 (66%) of arm A participants had good adherence to vitamin D/calcium supplementation. Significantly higher proportions of youth in arm A compared to arm B had >3% increase in LSBMD at month 6 compared to baseline (67.6% vs. 42.9% respectively; p = 0.03). There were significantly higher increases in LSBMD among youth with vitamin D deficiency who were supplemented; arm A + 0.05 (0 to 0.05) compared to arm B + 0.03 (-0.1 to 0.03), p = 0.04.
CONCLUSIONS


Increases in LSBMD over six months among youth using PrEP who received vitamin D/calcium supplementation was greater than those not supplemented. Long-term follow-up should be considered to explore long-term outcomes.",2020,Significantly higher proportions of youth in arm A compared to arm B had >3% increase in LSBMD at month 6 compared to baseline (67.6% vs. 42.9% respectively; p = 0.03).,"['male youth aged between 15 and 24\xa0years', 'From March 2019 to March 2020, 100 youth were enrolled', 'Thai youth receiving daily oral PrEP', 'Thai youth using daily HIV pre-exposure prophylaxis', '79 participants were evaluated']","['vitamin D and calcium supplementation', 'vitamin D/calcium supplementation', 'TDF', 'Tenofovir disoproxil fumarate with emtricitabine (TDF/FTC', 'TDF/FTC plus vitamin D3 and calcium supplementation with meals twice daily (400 units of vitamin D3 and 1200\xa0mg of elemental calcium/day) or Arm B who received once-daily TDF/FTC only']","['bone mineral density', 'bone mineral density (BMD', '25(OH)D levels', 'median amount of calcium intake', 'median (IQR) LSBMD z-score', 'LSBMD', 'Lumbar spine (L2-L4) BMD (LSBMD']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0039724', 'cui_str': 'Thai language'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}, {'cui': 'C1096319', 'cui_str': 'Prophylaxis against HIV infection'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C1096745', 'cui_str': 'Calcium supplement therapy'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}, {'cui': 'C0206682', 'cui_str': 'Follicular thyroid carcinoma'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4553624', 'cui_str': 'With meals'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C4517548', 'cui_str': '1200'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0489458', 'cui_str': 'Calcium intake'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}]",79.0,0.215788,Significantly higher proportions of youth in arm A compared to arm B had >3% increase in LSBMD at month 6 compared to baseline (67.6% vs. 42.9% respectively; p = 0.03).,"[{'ForeName': 'Krittaporn', 'Initials': 'K', 'LastName': 'Pornpaisalsakul', 'Affiliation': 'Department of Paediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Wipaporn Natalie', 'Initials': 'WN', 'LastName': 'Songtaweesin', 'Affiliation': 'Center of Excellence for Paediatric Infectious Diseases and Vaccines, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Supatporn', 'Initials': 'S', 'LastName': 'Tepmongkol', 'Affiliation': 'Department of Radiology, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Prissana', 'Initials': 'P', 'LastName': 'Wongharn', 'Affiliation': 'Center of Excellence for Paediatric Infectious Diseases and Vaccines, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Surinda', 'Initials': 'S', 'LastName': 'Kawichai', 'Affiliation': 'Center of Excellence for Paediatric Infectious Diseases and Vaccines, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Vichit', 'Initials': 'V', 'LastName': 'Suponsilchai', 'Affiliation': 'Department of Paediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Suvaporn', 'Initials': 'S', 'LastName': 'Anugulruengkitt', 'Affiliation': 'Department of Paediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Thanyawee', 'Initials': 'T', 'LastName': 'Puthanakit', 'Affiliation': 'Department of Paediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the International AIDS Society,['10.1002/jia2.25624']
3294,33040584,Association of Disease Progression With Cardiovascular and Limb Outcomes in Patients With Peripheral Artery Disease: Insights From the EUCLID Trial.,"BACKGROUND


Patients with peripheral artery disease have a high risk of future cardiovascular disease events and mortality. Little is known about the changes in symptom classification over time in patients with peripheral artery disease and the association of changes in symptom classification with subsequent cardiovascular disease events.
METHODS


In this analysis of the EUCLID trial (Examining Use of Ticagrelor in Peripheral Artery Disease), we examined the changes in Rutherford classification (RC) of patients over 12 months. We examined the baseline characteristics of patients by change in symptom classification at 12 months (improved=decreased RC, no change, or worsened=increased RC), and the association between changes in symptom classification (RC) at 12 months and subsequent cardiovascular disease events.
RESULTS


Among 12 759 patients, 3240 (25%) were classified as improved by RC at 12 months, 8132 (64%) as no change, and 1387 (11%) as worsened. At 12 months, many patients who were asymptomatic or had mild/moderate claudication at enrollment had no change in symptom classification over 12 months (73.7% and 70.9%). Patients who worsened over 12 months were more likely to have comorbidities (diabetes mellitus and prior myocardial infarction) and more events (myocardial infarction, amputation, and major bleeding) by 12 months postrandomization, all  P <0.001. Worsened symptom classification over 12 months was associated with increased risk of all-cause death (adjusted hazard ratio, 1.29 [95% CI, 1.03-1.62]), major amputation (adjusted hazard ratio, 4.12 [95% CI, 2.46-6.88]), and a composite of cardiovascular death, myocardial infarction, or stroke (adjusted hazard ratio, 1.30 [95% CI, 1.05-1.62]), all  P <0.05 after 12 months postrandomization.
CONCLUSIONS


Patients with comorbidities and prior history of cardiovascular disease events at baseline and within the first 12 months of the trial were more likely to have worsened symptom classification at 12 months. Worsening symptom classification over 12 months was associated subsequently with an increased risk of all-cause death, amputation, and a composite of cardiovascular death, myocardial infarction, or stroke. Graphic Abstract: A graphic abstract is available for this article.",2020,"Worsened symptom classification over 12 months was associated with increased risk of all-cause death (adjusted hazard ratio, 1.29 [95% CI, 1.03-1.62]), major amputation (adjusted hazard ratio, 4.12 [95% CI, 2.46-6.88]), and a composite of cardiovascular death, myocardial infarction, or stroke (adjusted hazard ratio, 1.30 [95% CI, 1.05-1.62]), all  P <0.05 after 12 months postrandomization.
","['Patients With Peripheral Artery Disease', 'patients with peripheral artery disease', 'Patients with peripheral artery disease']",['Ticagrelor'],"['Worsening symptom classification', 'mild/moderate claudication', 'major amputation', 'RC', 'composite of cardiovascular death, myocardial infarction, or stroke', 'risk of all-cause death', 'risk of all-cause death, amputation, and a composite of cardiovascular death, myocardial infarction, or stroke', 'comorbidities (diabetes mellitus and prior myocardial infarction) and more events (myocardial infarction, amputation, and major bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Arterial Diseases'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}]","[{'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0021775', 'cui_str': 'Intermittent claudication'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0155668', 'cui_str': 'Old myocardial infarction'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",12759.0,0.0906782,"Worsened symptom classification over 12 months was associated with increased risk of all-cause death (adjusted hazard ratio, 1.29 [95% CI, 1.03-1.62]), major amputation (adjusted hazard ratio, 4.12 [95% CI, 2.46-6.88]), and a composite of cardiovascular death, myocardial infarction, or stroke (adjusted hazard ratio, 1.30 [95% CI, 1.05-1.62]), all  P <0.05 after 12 months postrandomization.
","[{'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Rymer', 'Affiliation': 'Division of Cardiology, Duke University Medical Center, Durham, NC (J.A.R., D.I.N., W.S.J., M.R.P.).'}, {'ForeName': 'Hillary', 'Initials': 'H', 'LastName': 'Mulder', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC (H.M., F.R.).'}, {'ForeName': 'Dennis I', 'Initials': 'DI', 'LastName': 'Narcisse', 'Affiliation': 'Division of Cardiology, Duke University Medical Center, Durham, NC (J.A.R., D.I.N., W.S.J., M.R.P.).'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Rockhold', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC (H.M., F.R.).'}, {'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Hiatt', 'Affiliation': 'University of Colorado School of Medicine, CPC Clinical Research, Aurora (W.R.H.).'}, {'ForeName': 'F Gerry', 'Initials': 'FG', 'LastName': 'Fowkes', 'Affiliation': 'Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, United Kingdom (F.G.F).'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Baumgartner', 'Affiliation': 'Swiss Cardiovascular Center, Bern, Switzerland (I.B.).'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Berger', 'Affiliation': 'Division of Cardiology, NYU Langone Health, New York, NY (J.S.B.).'}, {'ForeName': 'Brian G', 'Initials': 'BG', 'LastName': 'Katona', 'Affiliation': 'AstraZeneca, Gaithersburg, MD (B.G.K.).'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Mahaffey', 'Affiliation': 'Stanford Center for Clinical Research, Stanford University School of Medicine, CA (K.M.).'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Norgren', 'Affiliation': 'Faculty of Medicine and Health, Orebro University, Sweden (L.N.).'}, {'ForeName': 'Juuso I', 'Initials': 'JI', 'LastName': 'Blomster', 'Affiliation': 'University of Turku, Finland (J.I.B.).'}, {'ForeName': 'W Schuyler', 'Initials': 'WS', 'LastName': 'Jones', 'Affiliation': 'Division of Cardiology, Duke University Medical Center, Durham, NC (J.A.R., D.I.N., W.S.J., M.R.P.).'}, {'ForeName': 'Manesh R', 'Initials': 'MR', 'LastName': 'Patel', 'Affiliation': 'Division of Cardiology, Duke University Medical Center, Durham, NC (J.A.R., D.I.N., W.S.J., M.R.P.).'}]",Circulation. Cardiovascular interventions,['10.1161/CIRCINTERVENTIONS.120.009326']
3295,32861830,Improving uptake of hepatitis B and hepatitis C testing in South Asian migrants in community and faith settings using educational interventions-A prospective descriptive study.,"BACKGROUND


Chronic viral hepatitis (CVH) is a leading contributor to the UK liver disease epidemic, with global migration from high prevalence areas (e.g., South Asia). Despite international guidance for testing high-risk groups in line with elimination targets, there is no consensus on how to achieve this. The objectives of this study were to assess the following: (1) the feasibility of recruiting South Asian migrants to view an educational film on CVH, (2) the effectiveness of the film in promoting testing and increasing knowledge of CVH, and (3) the methodological issues relevant to scale-up to a randomized controlled trial.
METHODS


South Asian migrants were recruited to view the film (intervention) in community venues (primary care, religious, community), with dried blood spot CVH testing offered immediately afterwards. Pre/post-film questionnaires assessed the effectiveness of the intervention.
RESULTS


Two hundred and nineteen first-generation migrants ≥18 years of age (53% female) were recruited to view the film at the following sites: religious, n = 112 (51%), community n = 98 (45%), and primary care, n = 9 (4%). One hundred and eighty-four (84%) underwent CVH testing; hepatitis B core antibody or hepatitis C antibody positivity demonstrated exposure in 8.5%. Pre-intervention (n = 173, 79%) and post-intervention (n = 154, 70%) questionnaires were completed.
CONCLUSIONS


This study demonstrated the feasibility of recruiting first-generation migrants to view a community-based educational film promoting CVH testing in this higher risk group, confirming the value of developing interventions to facilitate the global World Health Organization plan for targeted case finding and elimination, and a future randomized controlled trial. We highlight the importance of culturally relevant interventions including faith and culturally sensitive settings, which appear to minimize logistical issues and effectively engage minority groups, allowing ease of access to individuals 'at risk'.",2020,"Pre-intervention (n = 173, 79%) and post-intervention (n = 154, 70%) questionnaires were completed.
","['Chronic viral hepatitis (CVH', 'South Asian migrants were recruited to view the film (intervention) in community venues (primary care, religious, community), with', 'Two hundred and nineteen first-generation migrants ≥18 years of age (53% female']","['hepatitis B and hepatitis C testing', 'dried blood spot CVH testing offered immediately afterwards', 'CVH testing']",[],"[{'cui': 'C0276623', 'cui_str': 'Chronic viral hepatitis'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0026093', 'cui_str': 'Migrant'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C1704608', 'cui_str': 'Film'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0557075', 'cui_str': 'Has religious belief'}, {'cui': 'C4517648', 'cui_str': '219'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C2711110', 'cui_str': 'Hepatitis B and hepatitis C'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0276623', 'cui_str': 'Chronic viral hepatitis'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0205548', 'cui_str': 'Stat'}]",[],,0.0395415,"Pre-intervention (n = 173, 79%) and post-intervention (n = 154, 70%) questionnaires were completed.
","[{'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Kelly', 'Affiliation': 'Department of Gastroenterology and Hepatology, Royal Surrey NHS Foundation Trust, Guildford, Surrey, UK; Department of Clinical and Experimental Medicine, Faculty of Health and Medical Sciences, University of Surrey, Guildford, UK.'}, {'ForeName': 'Marinos', 'Initials': 'M', 'LastName': 'Pericleous', 'Affiliation': 'Department of Gastroenterology and Hepatology, Royal Surrey NHS Foundation Trust, Guildford, Surrey, UK; Department of Clinical and Experimental Medicine, Faculty of Health and Medical Sciences, University of Surrey, Guildford, UK.'}, {'ForeName': 'Ayesha', 'Initials': 'A', 'LastName': 'Ahmed', 'Affiliation': 'Brunel Business School, Brunel University, London, UK.'}, {'ForeName': 'Tushna', 'Initials': 'T', 'LastName': 'Vandrevala', 'Affiliation': 'Department of Psychology, Kingston University, London, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Hendy', 'Affiliation': 'Brunel Business School, Brunel University, London, UK.'}, {'ForeName': 'Shuja', 'Initials': 'S', 'LastName': 'Shafi', 'Affiliation': 'Research and Documentation Committee, The Muslim Council of Britain, London, UK.'}, {'ForeName': 'Simon S', 'Initials': 'SS', 'LastName': 'Skene', 'Affiliation': 'Department of Clinical and Experimental Medicine, Faculty of Health and Medical Sciences, University of Surrey, Guildford, UK.'}, {'ForeName': 'Sumita', 'Initials': 'S', 'LastName': 'Verma', 'Affiliation': 'Department of Clinical and Experimental Medicine, Brighton and Sussex Medical School and Department of Gastroenterology and Hepatology, Brighton and Sussex University Hospital, Brighton, UK.'}, {'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'Edge', 'Affiliation': 'Institute of Epidemiology and Health Care, UCL, London, UK.'}, {'ForeName': 'Margot', 'Initials': 'M', 'LastName': 'Nicholls', 'Affiliation': 'Public Health England South East, UK.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Gore', 'Affiliation': 'The Hepatitis C Trust, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'de Lusignan', 'Affiliation': 'Department of Clinical and Experimental Medicine, Faculty of Health and Medical Sciences, University of Surrey, Guildford, UK; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK; Royal College of General Practitioners Research and Surveillance Centre, London, UK.'}, {'ForeName': 'Aftab', 'Initials': 'A', 'LastName': 'Ala', 'Affiliation': 'Department of Gastroenterology and Hepatology, Royal Surrey NHS Foundation Trust, Guildford, Surrey, UK; Department of Clinical and Experimental Medicine, Faculty of Health and Medical Sciences, University of Surrey, Guildford, UK. Electronic address: aftab.ala1@nhs.net.'}]",International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases,['10.1016/j.ijid.2020.08.059']
3296,33044886,Effects of plyometric exercises on muscle-activation strategies and response-capacity to balance threats in children with hemiplegic cerebral palsy.,"OBJECTIVE


Children with hemiplegic cerebral palsy (hCP) experience a disorganized muscle activation pattern that adversely affect their ability to respond to balance perturbations. This study examined the effect of plyometric exercises on muscle-activation strategies and response-capacity to balance threats in children with hCP.
METHODS


In a pre-, posttest control-group study, 34 children with hCP were allocated randomly to either the control group ( n  = 17; received a traditional physical rehabilitation program, lasted for 45 minutes/session, twice/week for three successive months) or the plyometric group ( n  = 17; received a progressive plyometric training program in three blocks, twice/week over three months plus the traditional physical rehabilitation). Quadriceps/hamstring co-contraction ratio (Q/H Co-CR) and response-capacity to balance threats were assessed pre- and post-treatment.
RESULTS


Post-treatment, the Q/H Co-CR and balance control improved significantly in the control ( P  = .03,  P  = .0003 respectively) and plyomteric group ( P  = .001,  P  ˂ 0.001 respectively). However, the plyometric group showed better improvements in Q/H Co-CR ( P  = .0001) and balance control ( P  = .027) when compared to the control group.
CONCLUSION


Incorporation of plyometric exercises into traditional physical rehabilitation could improve muscle-activation strategies and enhance balance control in children with hCP.",2020,"However, the plyometric group showed better improvements in Q/H Co-CR ( P  = .0001) and balance control ( P  = .027) when compared to the control group.
","['children with hemiplegic cerebral palsy', '34 children with hCP', 'children with hCP', 'Children with hemiplegic cerebral palsy (hCP']","['traditional physical rehabilitation program', 'plyometric exercises', 'plyometric group ( n  =\xa017; received a progressive plyometric training program in three blocks, twice/week over three months plus the traditional physical rehabilitation']","['balance control', 'Q/H Co-CR', 'Quadriceps/hamstring co-contraction ratio (Q/H Co-CR) and response-capacity to balance threats', 'Q/H Co-CR and balance control']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0270805', 'cui_str': 'Hemiplegic cerebral palsy'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C3178799', 'cui_str': 'Plyometric Drill'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4082119', 'cui_str': 'Three months'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",34.0,0.013287,"However, the plyometric group showed better improvements in Q/H Co-CR ( P  = .0001) and balance control ( P  = .027) when compared to the control group.
","[{'ForeName': 'Ragab K', 'Initials': 'RK', 'LastName': 'Elnaggar', 'Affiliation': 'Department of Physical Therapy and Health Rehabilitation, College of Applied Medical Sciences, Prince Sattam Bin Abdulaziz University , Al-Kharj, Saudi Arabia.'}]",Physiotherapy theory and practice,['10.1080/09593985.2020.1833389']
3297,33044990,Experiences of tobacco cessation including a prescription approach among patients in Swedish primary health care with a focus on socioeconomically disadvantaged areas.,"BACKGROUND


Tobacco Cessation on Prescription (TCP) is a new intervention that is being evaluated in socioeconomically disadvantaged areas in Swedish primary health care (PHC). Patients' perceptions of TCP are important to understand as this may have implications for the acceptability and adherence to treatment and explain cessation outcomes. Patients' general experiences of tobacco cessation are also important to explore to improve cessation support in this setting.
AIM


To explore experiences of tobacco cessation and TCP among patients in Swedish PHC focusing on socioeconomically disadvantaged areas.
METHODS


Inductive content analysis of transcripts from eight semi-structured interviews with patients recruited from the intervention group in a randomized controlled trial evaluating the effectiveness of TCP in socioeconomically disadvantaged areas in PHC in Stockholm.
RESULTS


Two themes were identified: needing individualized support to quit, taking differences in patients' experiences of tobacco use and cessation into account, acknowledging individual factors such as impact of health and wellbeing on tobacco use and differing attitudes towards tobacco and cessation and needing a supportive environment to facilitate tobacco cessation, taking contextual factors like professional support from the health care system, the importance of the social environment and supportive societal structures into account. Regarding TCP, the prescription form was perceived as useful for providers but did not appear to have a direct impact on tobacco cessation from the informants' perspective. However, individualized counseling from a tobacco cessation specialist, an empathetic approach in the treatment and long-term follow-up was considered important.
CONCLUSION


A holistic approach may be needed in cessation treatment, combined with interventions outside the health care system, to facilitate tobacco cessation among patients in socioeconomically disadvantaged areas in Swedish PHC. The TCP prescription form may be helpful for PHC providers but counseling and follow-up appear to be the most important components of TCP for patients in this setting.",2020,"Regarding TCP, the prescription form was perceived as useful for providers but did not appear to have a direct impact on tobacco cessation from the informants' perspective.","['Inductive content analysis of transcripts from eight semi-structured interviews with patients recruited from the intervention group', 'patients in Swedish PHC focusing on socioeconomically disadvantaged areas', 'socioeconomically disadvantaged areas in PHC in Stockholm', 'patients in Swedish primary health care with a focus on socioeconomically disadvantaged areas', ""Patients' general experiences of tobacco cessation"", 'socioeconomically disadvantaged areas in Swedish primary health care (PHC', 'patients in socioeconomically disadvantaged areas in Swedish PHC']","['TCP', 'Tobacco Cessation on Prescription (TCP', 'tobacco cessation and TCP', 'tobacco cessation']",[],"[{'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038996', 'cui_str': 'Swedish language'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0012613', 'cui_str': 'Disadvantaged'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0600549', 'cui_str': 'Tobacco Cessation'}]","[{'cui': 'C0600549', 'cui_str': 'Tobacco Cessation'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}]",[],2.0,0.038746,"Regarding TCP, the prescription form was perceived as useful for providers but did not appear to have a direct impact on tobacco cessation from the informants' perspective.","[{'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Leppänen', 'Affiliation': 'Department of Learning, Informatics, Management and Ethics, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Solvig', 'Initials': 'S', 'LastName': 'Ekblad', 'Affiliation': 'Department of Learning, Informatics, Management and Ethics, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Tomson', 'Affiliation': 'Department of Learning, Informatics, Management and Ethics, Karolinska Institutet, Stockholm, Sweden.'}]",PloS one,['10.1371/journal.pone.0240411']
3298,33045536,Laser tongue debridement for oral malodor-A novel approach to halitosis.,"STUDY OBJECTIVE


Malodor is a multifactorial condition with oral pathology representing the main culprit and the tongue being the first to second contributor to the malodor. Bacterial load can represent a quantifiable measure regardless of the original pathology. We hypothesize that reduction in malodor can be represented by tongue changes both in appearance, bacterial and biofilm load reduction (measured by CFU and volatile gases measurement), organoleptic measurement and subjective improvement.
METHODS


A randomized controlled prospective study under IRB approval. Diagnostic criteria for enrollment and follow up were organoleptic test by 2 judges, Halimeter reading, tongue colors changes HALT questionnaire and direct aerobic and anaerobic tongue cultures measured by CFU. Patients were treated with laser tongue debridement (LTD) with an Er,Cr:YSGG solid state laser has been shown to be effective in biofilm reduction.
RESULTS


54 patients recruited with 35 available for follow up. Improvement was observed on all objective and QOL subjective parameters. Treatment was tolerated well with minimal discomfort.
CONCLUSIONS


The tongue is proven to be a major contributor to oral malodor and must be addressed in treatment protocol. LTD significantly reduces malodor by subjective and objective criteria. While impossible to determine whether the tongue serves as a bacterial reservoir or is the origin for oral bacteria it is clear that LTD improves oral hygiene and reduces malodor. LTD is safe and easy to perform. We encourage LTD to be a crucial part of any oral malodor treatment protocol.
TRIAL REGISTRATION


clinical trials, NCT04120948. Registered 25 September 2019 - Retrospectively registered, https://register.clinicaltrials.gov/prs/app/action/SelectProtocol?sid=S00098SX&selectaction=Edit&uid=U0000W0Y&ts=51&cx=-elnx7e.",2020,Improvement was observed on all objective and QOL subjective parameters.,"['Registered 25 September 2019 - Retrospectively registered, https://register.clinicaltrials.gov/prs/app/action/SelectProtocol?sid=S00098SX&selectaction=Edit&uid=U0000W0Y&ts=51&cx=-elnx7e', '54 patients recruited with 35 available for follow up']","['laser tongue debridement (LTD) with an Er,Cr:YSGG solid state laser', 'LTD', 'Laser tongue debridement for oral malodor']","['objective and QOL subjective parameters', 'oral hygiene and reduces malodor']","[{'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C1839730', 'cui_str': 'Prieto X-linked mental retardation syndrome'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0040408', 'cui_str': 'Tongue structure'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C1289836', 'cui_str': 'Solid-state laser device'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0029164', 'cui_str': 'Dental Hygiene'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]",54.0,0.0383094,Improvement was observed on all objective and QOL subjective parameters.,"[{'ForeName': 'Yosef P', 'Initials': 'YP', 'LastName': 'Krespi', 'Affiliation': 'Northwell Health, United States of America. Electronic address: ykrespi1@northwell.edu.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Kizhner', 'Affiliation': ""Mount Sinai St. Luke's, United States of America.""}, {'ForeName': 'Karen A', 'Initials': 'KA', 'LastName': 'Wilson', 'Affiliation': 'Northwell Health, United States of America.'}, {'ForeName': 'Alina', 'Initials': 'A', 'LastName': 'Sivriver', 'Affiliation': 'Biolase, Irvine, CA, United States of America.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Low', 'Affiliation': 'Biolase, Irvine, CA, United States of America.'}, {'ForeName': 'Yalda', 'Initials': 'Y', 'LastName': 'Khosravi', 'Affiliation': 'Ohio State University, Campus Microscopy and Imaging Facility, Departments of Microbial Infection and Immunity and Orthopaedics, Infectious Diseases Institute, United States of America.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Stoodley', 'Affiliation': 'Ohio State University, Campus Microscopy and Imaging Facility, Departments of Microbial Infection and Immunity and Orthopaedics, Infectious Diseases Institute, United States of America.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102458']
3299,33045627,Percutaneous pulsed radiofrequency treatment of dorsal root ganglion for treatment of lumbar facet syndrome.,"OBJECTIVES


Percutaneous radiofrequency denervation of the medial dorsal branch is often used for treatment of chronic low back pain originating from intervertebral facets, which is sometimes associated with a low success rate and a higher incidence of recurrence of pain. We theorized that implementing pulsed radiofrequency treatment to dorsal root ganglion would increase the probability of successful pain relief.
PATIENTS AND METHODS


150 patients diagnosed with CLBP of a confirmed facet origin were included in a prospective randomized controlled trial and were randomly divided into three equal groups, the first was submitted to percutaneous pulsed radiofrequency treatment of the dorsal root ganglia, the second underwent percutaneous radiofrequency denervation of the medial dorsal branch and the third was a control group that did not receive any radiofrequency treatment. Local injection of a mixture of local anesthetic and a steroid was given to the three groups. Cases were followed for a maximum of 3 years.
RESULTS


98 (65.3 %) patients were females. By 3 months' post procedure, improvement in VAS was significantly better than pretreatment levels in all groups (p= 0.026); the pulsed radiofrequency treatment group, however, had significantly better incidence of improvement when compared to the other two groups (p= 0.014).The control group lost improvement by 1-year follow-up (p=0.63). At 2 years' follow-up, the pulsed radiofrequency treatment of the dorsal root ganglia group maintained significant improvement (p= 0.041) whereas the medial branch denervation group lost its significant effect (p=0.32).By the end of follow-up period, only pulsed radiofrequency treatment of the dorsal root ganglia group kept significant improvement (p=0.044).
CONCLUSION


In CLBP of facet origin, pulsed radiofrequency treatment of the dorsal root ganglia provides both a higher incidence as well as an extended period of pain relief compared to radiofrequency ablation of the medial dorsal branch of the facet joint.",2020,"By 3 months' post procedure, improvement in VAS was significantly better than pretreatment levels in all groups (p= 0.026); the pulsed radiofrequency treatment group, however, had significantly better incidence of improvement when compared to the other two groups (p= 0.014).The control group lost improvement by 1-year follow-up (p=0.63).","['lumbar facet syndrome', '98 (65.3 %) patients were females', '150 patients diagnosed with CLBP of a confirmed facet origin']","['percutaneous pulsed radiofrequency treatment of the dorsal root ganglia, the second underwent percutaneous radiofrequency denervation of the medial dorsal branch and the third was a control group that did not receive any radiofrequency treatment', 'Percutaneous pulsed radiofrequency treatment of dorsal root ganglion', 'mixture of local anesthetic and a steroid']","['VAS', 'probability of successful pain relief']","[{'cui': 'C0458225', 'cui_str': 'Lumbar facet joint pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0222679', 'cui_str': 'Structure of articular surface of bone'}, {'cui': 'C0439659', 'cui_str': 'Origins'}]","[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0017070', 'cui_str': 'Structure of spinal nerve ganglion'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C1740811', 'cui_str': 'Radiofrequency denervation'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0205384', 'cui_str': 'Branching'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}]",150.0,0.0175157,"By 3 months' post procedure, improvement in VAS was significantly better than pretreatment levels in all groups (p= 0.026); the pulsed radiofrequency treatment group, however, had significantly better incidence of improvement when compared to the other two groups (p= 0.014).The control group lost improvement by 1-year follow-up (p=0.63).","[{'ForeName': 'Wael Mohamed', 'Initials': 'WM', 'LastName': 'Moussa', 'Affiliation': 'Department of Neurosurgery, Faculty of Medicine, Alexandria University, EL Khartoum Square, Azarita, Alexandria, Egypt. Electronic address: waelmmosa@yahoo.com.'}, {'ForeName': 'Wael', 'Initials': 'W', 'LastName': 'Khedr', 'Affiliation': 'Department of Neurosurgery, Faculty of Medicine, Alexandria University, EL Khartoum Square, Azarita, Alexandria, Egypt. Electronic address: waelkhedr2000@yahoo.com.'}, {'ForeName': 'Medhat', 'Initials': 'M', 'LastName': 'Elsawy', 'Affiliation': 'Department of Neurosurgery, Faculty of Medicine, El Menia University, Korneesh El Nil, El Menia, Egypt. Electronic address: medhatelsawy73@yahoo.com.'}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2020.106253']
3300,33045675,"A pilot study of the effects of chromium picolinate supplementation on serum fetuin-A, metabolic and inflammatory factors in patients with nonalcoholic fatty liver disease: A double-blind, placebo-controlled trial.","BACKGROUND


Evaluating the impact of chromium picolinate supplementation on glycemic status, lipid profile, inflammatory markers and fetuin-A in patients with non-alcoholic fatty liver disease (NAFLD).
METHODS


In present research, participants (N = 46) were randomized to (400 mcg/day, n = 23) chromium picolinate and placebo (n = 23) for 3 months.
RESULTS


Glucose indices, and lipid profiles, inflammatory biomarker and fetuin-A were measured before and after the intervention. Chromium reduced triglyceride (TG), atherogenic index of plasma (AIP), very-low-density lipoprotein (VLDL), insulin, homeostatic model assessment for insulin resistance (HOMA-IR), high-sensitivity C-reactive protein (hs-CRP), interleukin (IL) -6, tumor necrosis factor-alpha (TNF-α) and fetuin-A significantly compared to placebo group (p < 0.05). Furthermore, chromium significantly increased the quantitative insulin sensitivity check index (QUICKI). There were no significant differences in total cholesterol (TC), high-density lipoprotein cholesterol (HDL), low-density lipoprotein cholesterol (LDL), fasting blood sugar (FBS), Hemoglobin A1c (HbA1C), interleukin (IL)-17 between the two groups (p < 0.05).
CONCLUSION


Chromium picolinate significantly decreased TG, insulin, HOMA-IR, fetuin-A, the number of inflammatory factors, and increased QUICKI without changing FBS, HbA1C, TC, LDL, HDL, IL-17 levels and liver steatosis intensity in patients with NAFLD. Further studies by examining the effect of different doses of chromium and mechanisms of cellular action, would help further clarify the subject.",2020,"Furthermore, chromium significantly increased the quantitative insulin sensitivity check index (QUICKI).","['patients with NAFLD', 'patients with nonalcoholic fatty liver disease', 'participants (N\u202f=\u202f46', 'patients with non-alcoholic fatty liver disease (NAFLD']","['chromium picolinate and placebo', 'chromium picolinate supplementation', 'placebo', 'Chromium picolinate']","['serum fetuin-A, metabolic and inflammatory factors', 'Chromium reduced triglyceride (TG), atherogenic index of plasma (AIP), very-low-density lipoprotein (VLDL), insulin, homeostatic model assessment for insulin resistance (HOMA-IR), high-sensitivity C-reactive protein (hs-CRP), interleukin (IL) -6, tumor necrosis factor-alpha (TNF-α) and fetuin-A', 'quantitative insulin sensitivity check index (QUICKI', 'Glucose indices, and lipid profiles, inflammatory biomarker and fetuin-A', 'total cholesterol (TC), high-density lipoprotein cholesterol (HDL), low-density lipoprotein cholesterol (LDL), fasting blood sugar (FBS), Hemoglobin A1c (HbA1C), interleukin (IL)-17', 'glycemic status, lipid profile, inflammatory markers', 'TG, insulin, HOMA-IR, fetuin-A, the number of inflammatory factors, and increased QUICKI without changing FBS, HbA1C, TC, LDL, HDL, IL-17 levels and liver steatosis intensity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}]","[{'cui': 'C0163657', 'cui_str': 'CHROMIUM PICOLINATE'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C3160817', 'cui_str': 'Serum fetuin-A'}, {'cui': 'C0008574', 'cui_str': 'Chromium'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0023825', 'cui_str': 'Very low density lipoprotein'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0051477', 'cui_str': 'Alpha>2< hS glycoprotein'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C1283174', 'cui_str': 'Checking - action'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0384648', 'cui_str': 'Interleukin 17'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C3495427', 'cui_str': 'Fanconi-Bickel Syndrome'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015695', 'cui_str': 'Fatty Liver'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",46.0,0.22934,"Furthermore, chromium significantly increased the quantitative insulin sensitivity check index (QUICKI).","[{'ForeName': 'Fardin', 'Initials': 'F', 'LastName': 'Moradi', 'Affiliation': 'Student Research Committee, Faculty of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Tabriz, Iran; Nutrition Research Center, Department of Biochemistry & Diet Therapy, Faculty of Nutrition and Food Sciences, Tabriz University of Medical Science, Iran.'}, {'ForeName': 'Fateme', 'Initials': 'F', 'LastName': 'Kooshki', 'Affiliation': 'Student Research Committee, Faculty of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Tabriz, Iran; Nutrition Research Center, Department of Biochemistry & Diet Therapy, Faculty of Nutrition and Food Sciences, Tabriz University of Medical Science, Iran.'}, {'ForeName': 'Forough', 'Initials': 'F', 'LastName': 'Nokhostin', 'Affiliation': 'Assistant Professor of Internal Medicine, Dept. of Internal Medicine, Faculty of Medicine, Ahvaz Jundishapur University of Medical Science, Ahvaz, Iran.'}, {'ForeName': 'Manouchehr', 'Initials': 'M', 'LastName': 'Khoshbaten', 'Affiliation': 'Liver and Gastrointestinal Diseases Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Hadi', 'Initials': 'H', 'LastName': 'Bazyar', 'Affiliation': 'Student Research Committee, Ahvaz Jundishapur University of Medical Science, Ahvaz, Iran.'}, {'ForeName': 'Bahram', 'Initials': 'B', 'LastName': 'Pourghassem Gargari', 'Affiliation': 'Nutrition Research Center, Department of Biochemistry & Diet Therapy, Faculty of Nutrition and Food Sciences, Tabriz University of Medical Science, Iran. Electronic address: pourghassemb@tbzmed.ac.ir.'}]",Journal of trace elements in medicine and biology : organ of the Society for Minerals and Trace Elements (GMS),['10.1016/j.jtemb.2020.126659']
3301,33045769,Effects of Intraoperative Ventilation Strategy on Perioperative Atelectasis Assessed by Lung Ultrasonography in Patients Undergoing Open Abdominal Surgery: a Prospective Randomized Controlled Study.,"BACKGROUND


Protective mechanical ventilation using low tidal volume has been introduced to surgical patients to reduce the incidence of postoperative pulmonary complications. We investigated the effects of protective ventilation (PV) techniques on anesthesia-induced atelectasis identified via lung ultrasonography in patients undergoing abdominal surgery.
METHODS


A total of 42 adult patients who were scheduled for open abdominal surgery with an expected duration > 2 hours were included in the study. Patients were randomized to receive either conventional ventilation (CV; tidal volume of 9-10 mL/kg predicted body weight [PBW] with no positive end-expiratory pressure [PEEP]) or PV (tidal volume of 6-8 mL/kg PBW and 5 cmH₂O PEEP) via pressure-controlled ventilation with volume guaranteed. Lung ultrasonography was performed at four predefined time points to assess perioperative atelectasis by dividing each hemithorax into six quadrants based on a modified lung ultrasound (LUS) scoring system.
RESULTS


The tidal volume delivered to patients was 9.65 ± 1.65 mL/kg PBW in the CV group and 6.31 ± 0.62 mL/kg PBW in the PV group. Ventilation using low tidal volume led to similar LUS scores in all lung areas and at all time points compared to ventilation using high tidal volume. There was no significant difference between the groups in the number of patients requiring recruitment maneuvers at the end of surgery.
CONCLUSION


Ventilation with low tidal volume combined with 5 cmH₂O PEEP did not cause further loss of aeration compared to ventilation with high tidal volume. Low tidal volume ventilation can be used in patients without lung injury based on lung assessment by bedside lung ultrasonography.
TRIAL REGISTRATION


Clinical Research Information Service Identifier: KCT0003746.",2020,Ventilation using low tidal volume led to similar LUS scores in all lung areas and at all time points compared to ventilation using high tidal volume.,"['Patients Undergoing Open Abdominal Surgery', '42 adult patients who were scheduled for open abdominal surgery with an expected duration > 2 hours were included in the study', 'patients undergoing abdominal surgery', 'patients without lung injury based on lung assessment by bedside lung ultrasonography']","['Ventilation with low tidal volume combined with 5 cmH₂O PEEP', 'protective ventilation (PV) techniques', 'Low tidal volume ventilation', 'conventional ventilation (CV; tidal volume of 9-10 mL/kg predicted body weight [PBW] with no positive end-expiratory pressure [PEEP]) or PV (tidal volume of 6-8 mL/kg PBW and 5 cmH₂O PEEP) via pressure-controlled ventilation with volume guaranteed', 'Lung Ultrasonography', 'Intraoperative Ventilation Strategy', 'Lung ultrasonography']","['number of patients requiring recruitment maneuvers', 'LUS scores', 'tidal volume']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1292425', 'cui_str': '2 hours'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0273115', 'cui_str': 'Injury of lung'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0203463', 'cui_str': 'Ultrasonography of lung'}]","[{'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C1300574', 'cui_str': 'mL/kg'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0564626', 'cui_str': 'Pressure controlled ventilation'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0203463', 'cui_str': 'Ultrasonography of lung'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C4286019', 'cui_str': 'Lung ultrasound'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}]",42.0,0.0805521,Ventilation using low tidal volume led to similar LUS scores in all lung areas and at all time points compared to ventilation using high tidal volume.,"[{'ForeName': 'Sooyoung', 'Initials': 'S', 'LastName': 'Cho', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Ewha Womans University, School of Medicine, Seoul, Korea.'}, {'ForeName': 'Hye Won', 'Initials': 'HW', 'LastName': 'Oh', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Ewha Womans University, School of Medicine, Seoul, Korea.'}, {'ForeName': 'Min Hee', 'Initials': 'MH', 'LastName': 'Choi', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Ewha Womans University Mokdong Hospital, Seoul, Korea.'}, {'ForeName': 'Hyun Jung', 'Initials': 'HJ', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Ewha Womans University, School of Medicine, Seoul, Korea.'}, {'ForeName': 'Jae Hee', 'Initials': 'JH', 'LastName': 'Woo', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Ewha Womans University, School of Medicine, Seoul, Korea.'}]",Journal of Korean medical science,['10.3346/jkms.2020.35.e327']
3302,33046233,Ventricular reshaping with a beating heart implant improves pump function in experimental heart failure.,"OBJECTIVE


The left ventricle remodels from an ellipsoidal/conical shape to a spherical shape after a myocardial infarction. The spherical ventricle is inefficient as a pumping chamber, has higher wall stresses, and can lead to congestive heart failure. We sought to investigate if restoring physiological ventricular shape with a beating heart implant improves pump function.
METHODS


Rats were induced with a myocardial infarction, developing left ventricular dilatation and dysfunction, and becoming spherical over 3 weeks. Thereafter, they were randomized to undergo left ventricular reshaping with a beating heart implant (n = 19) or continue follow-up without an implant (n = 19). Biweekly echocardiography was performed until 12 weeks, with half the rats euthanized at 6 weeks and remaining at 12 weeks. At termination, invasive hemodynamic parameters and histopathology were performed.
RESULTS


At 3 weeks after the infarction, rats had a 22% fall in ejection fraction, 31% rise in end diastolic volume, and 23% rise in sphericity. Transventricular implant reshaping reduced the volume by 12.6% and sphericity by 21%, restoring physiologic ventricular shape and wall stress. Over the 12-week follow-up, pump function improved significantly with better ventricular-vascular coupling in the reshaped hearts. In this group, cardiomyocyte cross-section area was higher and the cells were less elongated.
CONCLUSIONS


Reshaping a postinfarction, failing left ventricle to restore its physiological conical shape significantly improves long-term pump function.",2020,"Over the 12-week follow-up, pump function improved significantly with better ventricular-vascular coupling in the reshaped hearts.","['experimental heart failure', 'Rats were induced with a myocardial infarction, developing left ventricular dilatation and dysfunction, and becoming spherical over 3 weeks']","['left ventricular reshaping with a beating heart implant (n\xa0=\xa019) or continue follow-up without an implant', 'Ventricular reshaping with a beating heart implant']","['sphericity', 'cardiomyocyte cross-section area', 'ejection fraction', 'restoring physiologic ventricular shape and wall stress', 'end diastolic volume']","[{'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0344911', 'cui_str': 'Left cardiac ventricular dilatation'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0332501', 'cui_str': 'Spherical shape'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0225828', 'cui_str': 'Cardiac myocyte'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}, {'cui': 'C0205380', 'cui_str': 'Walled'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",,0.0212346,"Over the 12-week follow-up, pump function improved significantly with better ventricular-vascular coupling in the reshaped hearts.","[{'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Onohara', 'Affiliation': 'Structural Heart Research & Innovation Laboratory, Carlyle Fraser Heart Center, Emory University Hospital Midtown, Atlanta, Ga.'}, {'ForeName': 'Daniella M', 'Initials': 'DM', 'LastName': 'Corporan', 'Affiliation': 'Structural Heart Research & Innovation Laboratory, Carlyle Fraser Heart Center, Emory University Hospital Midtown, Atlanta, Ga.'}, {'ForeName': 'Takanori', 'Initials': 'T', 'LastName': 'Kono', 'Affiliation': 'Structural Heart Research & Innovation Laboratory, Carlyle Fraser Heart Center, Emory University Hospital Midtown, Atlanta, Ga.'}, {'ForeName': 'Sandeep', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': 'Joint Department of Biomedical Engineering, Emory University/Georgia Institute of Technology, Atlanta, Ga.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Guyton', 'Affiliation': 'Structural Heart Research & Innovation Laboratory, Carlyle Fraser Heart Center, Emory University Hospital Midtown, Atlanta, Ga; Division of Cardiothoracic Surgery, Department of Surgery, Emory University School of Medicine, Atlanta, Ga.'}, {'ForeName': 'Muralidhar', 'Initials': 'M', 'LastName': 'Padala', 'Affiliation': 'Structural Heart Research & Innovation Laboratory, Carlyle Fraser Heart Center, Emory University Hospital Midtown, Atlanta, Ga; Joint Department of Biomedical Engineering, Emory University/Georgia Institute of Technology, Atlanta, Ga; Division of Cardiothoracic Surgery, Department of Surgery, Emory University School of Medicine, Atlanta, Ga. Electronic address: spadala@emory.edu.'}]",The Journal of thoracic and cardiovascular surgery,['10.1016/j.jtcvs.2020.08.097']
3303,33046465,Effectiveness and cost-effectiveness of a virtual community of practice to improve the empowerment of patients with ischaemic heart disease: study protocol of a randomised controlled trial.,"INTRODUCTION


Virtual Communities of Practice (VCoP) or knowledge-sharing virtual communities offer ubiquitous access to information and exchange possibilities for people in similar situations, which might be especially valuable for the self-management of patients with chronic diseases. In view of the scarce evidence on the clinical and economic impact of these interventions on chronic conditions, we aim to evaluate the effectiveness and cost-effectiveness of a VCoP in the improvement of the activation and other patient empowerment measures in patients with ischaemic heart disease (IHD).
METHODS AND ANALYSIS


A pragmatic randomised controlled trial will be performed in Catalonia, Madrid and Canary Islands, Spain. Two hundred and fifty patients with a recent diagnosis of IHD attending the participating centres will be selected and randomised to the intervention or control group. The intervention group will be offered participation for 12 months in a VCoP based on a gamified web 2.0 platform where there is interaction with other patients and a multidisciplinary professional team. Intervention and control groups will receive usual care. The primary outcome will be measured with the Patient Activation Measure questionnaire at baseline, 6, 12 and 18 months. Secondary outcomes will include: clinical variables; knowledge (Questionnaire of Cardiovascular Risk Factors), attitudes (Self-efficacy Managing Chronic Disease Scale), adherence to the Mediterranean diet (Mediterranean Diet Questionnaire), level of physical activity (International Physical Activity Questionnaire), depression (Patient Health Questionnaire), anxiety (Hospital Anxiety Scale-A), medication adherence (Adherence to Refill Medication Scale), quality of life (EQ-5D-5L) and health resources use. Data will be collected from self-reported questionnaires and electronic medical records.
ETHICS AND DISSEMINATION


The trial was approved by Clinical Research Ethics Committee of Gregorio Marañón University Hospital in Madrid, Nuestra Señora de Candelaria University Hospital in Santa Cruz de Tenerife and IDIAP Jordi Gol in Barcelona. The results will be disseminated through workshops, policy briefs, peer-reviewed publications, local/international conferences.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov Registry (NCT03959631). Pre-results.",2020,"INTRODUCTION


Virtual Communities of Practice (VCoP) or knowledge-sharing virtual communities offer ubiquitous access to information and exchange possibilities for people in similar situations, which might be especially valuable for the self-management of patients with chronic diseases.","['Gregorio Marañón University Hospital in Madrid, Nuestra Señora de Candelaria University Hospital in Santa Cruz de Tenerife and IDIAP Jordi Gol in Barcelona', 'patients with chronic diseases', 'patients with ischaemic heart disease (IHD', 'patients with ischaemic heart disease', 'Two hundred and fifty patients with a recent diagnosis of IHD attending the participating centres']",['VCoP'],"['Patient Activation Measure questionnaire', 'effectiveness and cost-effectiveness', ' clinical variables; knowledge (Questionnaire of Cardiovascular Risk Factors), attitudes (Self-efficacy Managing Chronic Disease Scale), adherence to the Mediterranean diet (Mediterranean Diet Questionnaire), level of physical activity (International Physical Activity Questionnaire), depression (Patient Health Questionnaire), anxiety (Hospital Anxiety Scale-A), medication adherence (Adherence to Refill Medication Scale), quality of life (EQ-5D-5L) and health resources use', 'Effectiveness and cost-effectiveness']","[{'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0454686', 'cui_str': 'Tenerife'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C4075707', 'cui_str': 'Patient Activation Measure'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0018741', 'cui_str': 'Health Resources'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",250.0,0.140729,"INTRODUCTION


Virtual Communities of Practice (VCoP) or knowledge-sharing virtual communities offer ubiquitous access to information and exchange possibilities for people in similar situations, which might be especially valuable for the self-management of patients with chronic diseases.","[{'ForeName': 'Ana Isabel', 'Initials': 'AI', 'LastName': 'González-González', 'Affiliation': 'Goethe-Universitat Frankfurt am Main Institut fur Allgemeinmedizin, Frankfurt am Main, Hessen, Germany gonzalezgonzalez@allgemeinmedizin.uni-frankfurt.de.'}, {'ForeName': 'Lilisbeth', 'Initials': 'L', 'LastName': 'Perestelo-Pérez', 'Affiliation': 'Servicio de Evaluación y Planificación del Servicio Canario de la Salud, Tenerife, Spain.'}, {'ForeName': 'Débora', 'Initials': 'D', 'LastName': 'Koatz', 'Affiliation': 'Avedis Donabedian Research Institute (FAD), Barcelona, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Ballester', 'Affiliation': 'Avedis Donabedian Research Institute (FAD), Barcelona, Spain.'}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Pacheco-Huergo', 'Affiliation': 'Avedis Donabedian Research Institute (FAD), Barcelona, Spain.'}, {'ForeName': 'Vanesa', 'Initials': 'V', 'LastName': 'Ramos-García', 'Affiliation': 'Fundación Canaria Instituto de Investigación Sanitaria de Canarias (FISC), Tenerife, Spain.'}, {'ForeName': 'Alezandra', 'Initials': 'A', 'LastName': 'Torres-Castaño', 'Affiliation': 'Fundación Canaria Instituto de Investigación Sanitaria de Canarias (FISC), Tenerife, Spain.'}, {'ForeName': 'Amado', 'Initials': 'A', 'LastName': 'Rivero-Santana', 'Affiliation': 'Servicio de Evaluación y Planificación del Servicio Canario de la Salud, Tenerife, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Toledo-Chávarri', 'Affiliation': 'Red de Investigación en Servicios de Salud en Enfermedades Crónicas (REDISSEC), Tenerife, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Valcárcel-Nazco', 'Affiliation': 'Fundación Canaria Instituto de Investigación Sanitaria de Canarias (FISC), Tenerife, Spain.'}, {'ForeName': 'Juana', 'Initials': 'J', 'LastName': 'Mateos-Rodilla', 'Affiliation': 'Escuela Madrileña de Salud, Dirección General de Humanización y Atención al Paciente, Madrid, Spain.'}, {'ForeName': 'Juan Carlos', 'Initials': 'JC', 'LastName': 'Obaya-Rebollar', 'Affiliation': 'Centro de Salud Chopera, Gerencia Asistencial de Atención Primaria, Madrid, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'García-García', 'Affiliation': 'Unidad de Calidad y Seguridad del Paciente. Hospital Universitario Nuestra Señora de Candelaria, Tenerife, Spain.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Díaz-Sánchez', 'Affiliation': 'Centro de Salud Pintores, Gerencia Asistencial de Atención Primaria, Madrid, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Morales-Cobos', 'Affiliation': 'Centro de Salud Las Américas, Gerencia Asistencial de Atención Primaria, Madrid, Spain.'}, {'ForeName': 'Josep María', 'Initials': 'JM', 'LastName': 'Bosch-Fontcuberta', 'Affiliation': 'Centro de Atención Primaria Encants, Instituto Catalán de la Salud, Barcelona, Spain.'}, {'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Vallejo-Camazón', 'Affiliation': 'Hospital Germans Trias i Pujol, Badalona, Catalunya, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Rodríguez-Almodovar', 'Affiliation': 'UGC Cardiología, Hospital Universitario Reina Sofía, Códoba, Spain.'}, {'ForeName': 'José Carlos', 'Initials': 'JC', 'LastName': 'Del Castillo', 'Affiliation': 'Cardiovascular Area, Hospital San Juan de Dios, Tenerife, Canarias, Spain.'}, {'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'Muñoz-Balsa', 'Affiliation': 'Unidad de Apoyo Técnico, Gerencia Asistencial Atención Primaria, Servicio Madrileño de Salud, Madrid, Spain.'}, {'ForeName': 'Yolanda', 'Initials': 'Y', 'LastName': 'Del Rey-Granado', 'Affiliation': 'Unidad de Apoyo Técnico, Gerencia Asistencial Atención Primaria, Servicio Madrileño de Salud, Madrid, Spain.'}, {'ForeName': 'Sofía', 'Initials': 'S', 'LastName': 'Garrido-Elustondo', 'Affiliation': 'Centre Family and Community Care Teaching Multiprofessional Unit, Comunidad de Madrid Consejeria de Sanidad, Madrid, Spain.'}, {'ForeName': 'María-Eugenia', 'Initials': 'ME', 'LastName': 'Tello-Bernabé', 'Affiliation': 'Centro de Salud El Naranjo, Gerencia Asistencial Atención Primaria, Servicio Madrileño de Salud, Madrid, Spain.'}, {'ForeName': 'Ana Belén', 'Initials': 'AB', 'LastName': 'Ramírez-Puerta', 'Affiliation': 'Unidad de Apoyo Técnico, Gerencia Asistencial Atención Primaria, Servicio Madrileño de Salud, Madrid, Spain.'}, {'ForeName': 'Carola', 'Initials': 'C', 'LastName': 'Orrego', 'Affiliation': 'Avedis Donabedian Research Institute (FAD), Barcelona, Spain.'}]",BMJ open,['10.1136/bmjopen-2020-037374']
3304,33047405,"Comparative efficacy between localized 308-nm excimer light and targeted 311-nm narrowband ultraviolet B phototherapy in vitiligo: A randomized, single-blind comparison study.","BACKGROUND


There are limited data to compare efficacy between recent 308-nm excimer and conventional 311-nm narrowband ultraviolet B (NB-UVB) light in the treatment of vitiligo.
OBJECTIVE


To compare efficacy between 308-nm excimer light and 311-nm NB-UVB in patients with symmetrical vitiligo lesions.
METHODS


Thirty-six symmetrically paired vitiligo lesions on the same anatomical area were enrolled. One side of the symmetrical lesions was treated with localized 308-nm excimer light, and the opposite side was treated with targeted 311-nm NB-UVB assigned randomly by computer. All lesions were treated with the same protocol, for 48 sessions. Repigmentation was evaluated using Vitiligo Area Scoring Index (VASI) and grading the repigmentation was carried out with three independent investigators.
RESULTS


Thirty-six symmetrically vitiligo lesions were randomly treated, one side with 308-nm excimer light and the opposite side with 311-nm NB-UVB. After 48 sessions, a significantly lower VASI score and a higher grade of repigmentation were observed in 308-nm excimer light-treated side (P < .001). Nine lesions (25%) treated with 308-nm excimer light and only five lesions (13.89%) treated with 311-nm NB-UVB achieved excellent repigmentation. The 308-nm excimer light and 311-nm NB-UVB-treated sides rapidly obtained 25% repigmentation within a mean of 19.42 sessions and 26.25 sessions, respectively (P = .002). There was no significant difference in mean cumulative UV dosage (P = .065). Side effect as phototoxicity was similar in both sides (P = .08).
CONCLUSION


Localized 308-nm excimer light appears to be more effective and also more rapidly induces repigmentation than targeted 311-nm NB-UVB for treatment of vitiligo.",2020,There was no significant difference in mean cumulative UV dosage (p = 0.065).,"['Thirty-six symmetrically vitiligo lesions', 'vitiligo', 'patients with symmetrical vitiligo lesions', 'Thirty-six symmetrically paired vitiligo lesions on the same anatomical area were enrolled']","['308-nm excimer light and 311-nm NB-UVB', 'localized 308-nm excimer light and the opposite side', '308-nm excimer light', 'localized 308-nm Excimer Light and targeted 311-nm Narrowband Ultraviolet B Phototherapy', '308-nm excimer and conventional 311-nm NB-UVB light']","['phototoxicity', 'mean cumulative UV dosage', 'excellent repigmentation', 'VASI score', 'Vitiligo Area Scoring index (VASI']","[{'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0042900', 'cui_str': 'Vitiligo'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332516', 'cui_str': 'Symmetrical'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0454530', 'cui_str': 'Ultraviolet B therapy'}, {'cui': 'C0392752', 'cui_str': 'Localized'}, {'cui': 'C3472306', 'cui_str': 'Narrowband ultraviolet B phototherapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0162830', 'cui_str': 'Phototoxic dermatitis'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1961136', 'cui_str': 'Excellent'}, {'cui': 'C0042900', 'cui_str': 'Vitiligo'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0353462,There was no significant difference in mean cumulative UV dosage (p = 0.065).,"[{'ForeName': 'Pimsiri', 'Initials': 'P', 'LastName': 'Poolsuwan', 'Affiliation': 'Institute of Dermatology, Department of Medical Services, Ministry of Public Health, Bangkok, Thailand.'}, {'ForeName': 'Chutima', 'Initials': 'C', 'LastName': 'Churee', 'Affiliation': 'Institute of Dermatology, Department of Medical Services, Ministry of Public Health, Bangkok, Thailand.'}, {'ForeName': 'Bensachee', 'Initials': 'B', 'LastName': 'Pattamadilok', 'Affiliation': 'Institute of Dermatology, Department of Medical Services, Ministry of Public Health, Bangkok, Thailand.'}]","Photodermatology, photoimmunology & photomedicine",['10.1111/phpp.12619']
3305,33047411,"Functional recovery in human partial thickness skin wounds after application of multicomponent hydrolipidic film (MAS063DP): A prospective, open-label, comparative clinical trial.","Acute and minor skin wounds are common in daily life. However, in clinical practice, after initial management in the acute phase, the wounds are managed mainly through observation, and the patients are usually lost to follow-up. Considering a multicomponent hydrolipidic dressing (MAS063DP) long-known for its safe application in eczema and recently in laser-induced wounds, we aimed to evaluate its ability in functional recovery of impaired skin integrity during wound healing. Sixteen patients (N = 16) were enrolled and completed (n = 8 vs n = 8) this prospective, open-label, vehicle-controlled clinical trial with 12-week follow-up. Transepidermal water, skin viscoelasticity and bioimpedance analysis were measured initially, at the 1st, 4th, 8th, and 12th weeks. Improvements in these parameters were greater in the MAS063DP group (from 31.4 ± 9.0 to 16.4 ± 4.3 g/m 2  h, P < .001; from 77 ± 16% to 88 ± 9%, P < .05; from 4182 ± 3823 to 2644 ± 1772 Ω) than in the white petrolatum group. No significant adverse events occurred, and all participants were more satisfied with the intervention. In this study, MAS063DP can restore skin integrity and reinstitute physiologic function as a feasible and safe intervention more markedly than management through observation during the healing process by providing protective hydrolipidic layer on the skin with simultaneous anti-inflammatory and antioxidant activities from its key ingredients such as glycyrrhetinic acid, Vitis vinifera, telmesteine, and vitamins C and E.",2020,"No significant adverse events occurred, and all participants were more satisfied with the intervention.",['Sixteen patients (N=16) were enrolled and completed (n=8 vs. n=8'],"['Multicomponent Hydrolipidic Film (MAS063DP', 'multicomponent hydrolipidic dressing (MAS063DP', 'MAS063DP']","['adverse events', 'Transepidermal water, skin viscoelasticity and bioimpedance analysis']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C1704608', 'cui_str': 'Film'}, {'cui': 'C2355254', 'cui_str': 'MAS063DP'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]",,0.0241507,"No significant adverse events occurred, and all participants were more satisfied with the intervention.","[{'ForeName': 'Erh-Ti', 'Initials': 'ET', 'LastName': 'Lin', 'Affiliation': 'Department of Education, China Medical University Hospital, Taichung, Taiwan, Republic of China.'}, {'ForeName': 'Bor-Shyh', 'Initials': 'BS', 'LastName': 'Lin', 'Affiliation': 'Institute of Imaging and Biomedical Photonics, National Chiao Tung University, Tainan, Taiwan, Republic of China.'}, {'ForeName': 'Li-Cheng', 'Initials': 'LC', 'LastName': 'Tsai', 'Affiliation': 'Department of Education, China Medical University Hospital, Taichung, Taiwan, Republic of China.'}, {'ForeName': 'Wei-Kung', 'Initials': 'WK', 'LastName': 'Chen', 'Affiliation': 'Department of Emergency, China Medical University Hospital, Taichung, Taiwan, Republic of China.'}, {'ForeName': 'Yen-Jen', 'Initials': 'YJ', 'LastName': 'Wang', 'Affiliation': 'Department of Dermatology, Mackay Memorial Hospital, Taipei, Taiwan, Republic of China.'}, {'ForeName': 'Hsiu-Mei', 'Initials': 'HM', 'LastName': 'Chiang', 'Affiliation': 'Department of Cosmeceutics and Graduate Institute of Cosmeceutics, China Medical University, Taichung, Taiwan, Republic of China.'}, {'ForeName': 'Chang-Cheng', 'Initials': 'CC', 'LastName': 'Chang', 'Affiliation': 'Aesthetic Medical Center, China Medical University Hospital, Taichung, Taiwan, Republic of China.'}]",Wound repair and regeneration : official publication of the Wound Healing Society [and] the European Tissue Repair Society,['10.1111/wrr.12866']
3306,33047449,"Effect of one session of aerobic exercise associated with abdominal laser therapy in lipolytic activity, lipid profile, and inflammatory markers.","BACKGROUND


Increased abdominal fat and sedentary lifestyles contribute to cardiovascular disease risk. The combination of exercise and low-level laser therapy (LLLT) appears to be an innovative method to increase the lipolytic rate of abdominal adipocytes, in order to reduce abdominal fat.
OBJECTIVES


To evaluate the effect of one session of aerobic exercise associated with abdominal laser therapy in lipolytic activity, profile lipid, and inflammatory markers (C-reactive protein-CRP).
METHODS


Experimental randomized controlled study in 36 participants of female sex divided into three groups: placebo group (PG) (n = 12), experimental group 1 (EG1) (n = 11), and experimental group 2 (EG2) (n = 13). The EG1 and EG2 performed the laser therapy protocol followed by 50 minutes of aerobic exercise on cycle ergometer, of 45%-55% of reserve heart rate; however, in EG2 the laser therapy was applied without power. The PG only performed the laser therapy protocol without power. The anthropometric measures were evaluated, and all participants were subject to blood samples at the beginning and at the end of the intervention for measure glycerol, lipid profile (total cholesterol, triglycerides, HDL, and LDL), and CRP. One-way ANOVA was used to compare the groups in the quantitative variables and Fisher's test to compare the groups in the qualitative variables. To compare the variables between moments (M0 and M1), we used the t test for paired samples.
RESULTS


In the group that performed physical exercise and lipolytic laser and in the group that performs only physical exercise, there was a significant increase in glycerol mobilization between M0 and M1 (P < .001). The same did not occur in the placebo group. Regarding the CRP levels and lipidic profile, no significant differences were observed between moments in the experimental groups.
CONCLUSION


It is concluded that one session of aerobic exercise associated with LLLT and one session of aerobic exercise appears to be able to increase the lipolytic activity. However, it appears that LLLT does not provide increased value to the aerobic physical exercise by itself in lipolysis process.",2020,"Regarding the CRP levels and lipidic profile, no significant differences were observed between moments in the experimental groups.
",['36 participants of female sex'],"['physical exercise and lipolytic laser', 'placebo', 'aerobic exercise', 'Placebo', 'abdominal laser therapy']","['lipolytic activity, profile lipid and inflammatory markers', 'CRP levels and lipidic profile', 'lipolytic activity', 'glycerol mobilization', 'glycerol, lipid profile (total cholesterol, triglycerides, HDL and LDL) and CRP']","[{'cui': 'C0086287', 'cui_str': 'Female'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0017861', 'cui_str': 'Glycerin'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}]",36.0,0.0299662,"Regarding the CRP levels and lipidic profile, no significant differences were observed between moments in the experimental groups.
","[{'ForeName': 'Patrícia', 'Initials': 'P', 'LastName': 'Barbosa', 'Affiliation': 'Department of Physiotherapy, School of Health, Polytechnic Institute of Porto, Porto, Portugal.'}, {'ForeName': 'Catarina', 'Initials': 'C', 'LastName': 'Coimbra', 'Affiliation': 'Department of Physiotherapy, School of Health, Polytechnic Institute of Porto, Porto, Portugal.'}, {'ForeName': 'Andreia', 'Initials': 'A', 'LastName': 'Noites', 'Affiliation': 'Department of Physiotherapy, School of Health, Polytechnic Institute of Porto, Porto, Portugal.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Vilarinho', 'Affiliation': 'Department of Physiotherapy, School of Health, Polytechnic Institute of Porto, Porto, Portugal.'}, {'ForeName': 'Paulo', 'Initials': 'P', 'LastName': 'Carvalho', 'Affiliation': 'Department of Physiotherapy, School of Health, Polytechnic Institute of Porto, Porto, Portugal.'}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Amorim', 'Affiliation': 'Department of Clinical Analysis, School of Health, Polytechnic Institute of Porto, Porto, Portugal.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Moreira', 'Affiliation': 'Department of Clinical Analysis, School of Health, Polytechnic Institute of Porto, Porto, Portugal.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Melo', 'Affiliation': 'Department of Physiotherapy, School of Health, Polytechnic Institute of Porto, Porto, Portugal.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13781']
3307,33061884,"Efficacy of  Labisia pumila  and  Eurycoma longifolia  standardised extracts on hot flushes, quality of life, hormone and lipid profile of peri-menopausal and menopausal women: a randomised, placebo-controlled study.","Background


Interest in herbal medicines and non-hormonal therapies for the treatment of menopausal symptoms has increased since the publication of adverse effects of estrogen replacement therapy. Vasomotor symptoms are the most characteristic and notable symptoms of menopause.
Objective


To investigate the changes in the frequency and severity of hot flush and associated vasomotor symptoms experienced by peri-menopausal and menopausal women supplemented with the herbal formulation (Nu-femme™) comprising  Labisia pumila  (SLP+ ® ) and  Eurycoma longifolia  (Physta ® ) or placebo.
Design


Randomised, double-blind, placebo-controlled, 24-week study enrolled 119 healthy women aged 41-55 years experiencing peri-menopausal or menopausal symptoms and supplemented with Nu-femme™ or placebo. The primary endpoint was comparative changes between treatment groups in the change in the frequency and severity of hot flushes. The secondary objectives were to assess the changes in the frequency and severity of joint pain, Menopause Rating Scale (MRS) and Menopause-Specific Quality of Life (MENQOL) questionnaire domain scores. Concentrations of serum hormone, lipid profile, bone markers, sleep quality and vitality were also studied as secondary objectives.
Results


At week 12, significant ( P  < 0.01) improvements in hot flush symptoms were observed in Nu-femme™ and placebo groups. Even though there was no significant difference between groups, higher percentage of improvement, 65%, was seen in Nu-femme™ compared to 60% in placebo. Significant improvements ( P  < 0.001) in MRS and MENQOL scores at weeks 12 and 24 were observed in both groups, respectively. Luteinising hormone and follicle-stimulating hormone levels were significantly reduced ( P  < 0.05) at weeks 12 and 24, respectively, compared to baseline in the Nu-femme™ group, with no significant changes observed in the placebo group. There were significant ( P  < 0.05) reductions in serum low-density lipid and triglycerides levels at week 12 in Nu-femme™ group, but no changes seen in placebo group. At the end of week 24, changes in haematology and clinical chemistry parameters remained within normal clinical ranges in both groups.
Conclusion


Herbal formulation consists of  L. pumila  and  E. longifolia  (Nu-femme™) may support reduction in hot flushes and improvements in hormone and lipid profile in healthy peri-menopausal and menopausal women.",2020,"There were significant ( P  < 0.05) reductions in serum low-density lipid and triglycerides levels at week 12 in Nu-femme™ group, but no changes seen in placebo group.","['peri-menopausal and menopausal women', 'healthy peri-menopausal and menopausal women', '119 healthy women aged 41-55 years experiencing peri-menopausal or menopausal symptoms and supplemented with Nu-femme™ or']","['peri-menopausal and menopausal women supplemented with the herbal formulation (Nu-femme™) comprising  Labisia pumila  (SLP+ ® ) and  Eurycoma longifolia  (Physta ® ) or placebo', 'placebo', 'Labisia pumila  and']","['frequency and severity of hot flushes', 'Concentrations of serum hormone, lipid profile, bone markers, sleep quality and vitality', 'serum low-density lipid and triglycerides levels', 'frequency and severity of joint pain, Menopause Rating Scale (MRS) and Menopause-Specific Quality of Life (MENQOL) questionnaire domain scores', 'MRS and MENQOL scores', 'haematology and clinical chemistry parameters', 'hot flushes, quality of life, hormone and lipid profile', 'Luteinising hormone and follicle-stimulating hormone levels', 'Vasomotor symptoms', 'hormone and lipid profile', 'hot flush symptoms']","[{'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0236075', 'cui_str': 'Menopausal symptom'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]","[{'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0376667', 'cui_str': 'Herbals'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C1258070', 'cui_str': 'Long Jack'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600142', 'cui_str': 'Menopausal flushing'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0181734', 'cui_str': 'Bone marker'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0202236', 'cui_str': 'Triglycerides measurement'}, {'cui': 'C0003862', 'cui_str': 'Joint pain'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1274119', 'cui_str': 'Hematopathology'}, {'cui': 'C0008000', 'cui_str': 'Clinical Chemistry'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0202022', 'cui_str': 'Follicle stimulating hormone measurement'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",119.0,0.287503,"There were significant ( P  < 0.05) reductions in serum low-density lipid and triglycerides levels at week 12 in Nu-femme™ group, but no changes seen in placebo group.","[{'ForeName': 'Sasikala M', 'Initials': 'SM', 'LastName': 'Chinnappan', 'Affiliation': 'Biotropics Malaysia Berhad, Section U1Hicom Glenmarie, Industrial Park Shah Alam, Selangor, Malaysia.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'George', 'Affiliation': 'Biotropics Malaysia Berhad, Section U1Hicom Glenmarie, Industrial Park Shah Alam, Selangor, Malaysia.'}, {'ForeName': 'Malkanthi', 'Initials': 'M', 'LastName': 'Evans', 'Affiliation': 'KGK Science, London, ON, Canada.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Anthony', 'Affiliation': 'KGK Science, London, ON, Canada.'}]",Food & nutrition research,['10.29219/fnr.v64.3665']
3308,33061895,Right Temporoparietal Junction Modulates In-Group Bias in Facial Emotional Mimicry: A tDCS Study.,"The present study employs transcranial direct current stimulation (tDCS), a non-invasive brain stimulation technique, to explore the possible role of the right temporoparietal junction (rTPJ) in regulating in-group bias in facial emotional mimicry. Participants received either anodal or cathodal stimulation, or they were assigned to a sham condition. After that, they passively viewed a series of video clips depicting different emotions (happiness and anger) that were performed either by ethnic in-group or out-group models. The emotion-specific muscle activities, zygomatic major (ZM) and corrugator supercilii (CS) were recorded simultaneously as the index of facial emotional mimicry. The results first confirm the in-group bias in facial emotional mimicry in the sham condition, as shown in prior studies, though it only occurs in happy mimicry. Moreover, the in-group bias in facial emotional mimicry is modulated by the cortical excitability over the rTPJ, which may be attributed to the accompanied change of overlap of the mental representations of in-group and out-group. This study provides a close look at the neural underpinning of the modulation of facial emotional mimicry by group membership and highlights the role of rTPJ in on-line control of co-activated self and other representations in social cognition.",2020,"The emotion-specific muscle activities, zygomatic major (ZM) and corrugator supercilii (CS) were recorded simultaneously as the index of facial emotional mimicry.",['Facial Emotional Mimicry'],"['right temporoparietal junction (rTPJ', 'anodal or cathodal stimulation', 'rTPJ', 'transcranial direct current stimulation (tDCS']","['emotion-specific muscle activities, zygomatic major (ZM) and corrugator supercilii (CS', 'facial emotional mimicry']","[{'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0233577', 'cui_str': 'Mimicry'}]","[{'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0205144', 'cui_str': 'Junctional'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0224127', 'cui_str': 'Structure of corrugator supercilii muscle'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0233577', 'cui_str': 'Mimicry'}]",,0.0259309,"The emotion-specific muscle activities, zygomatic major (ZM) and corrugator supercilii (CS) were recorded simultaneously as the index of facial emotional mimicry.","[{'ForeName': 'Shenli', 'Initials': 'S', 'LastName': 'Peng', 'Affiliation': 'College of Education, Hunan Agricultural University, Changsha, China.'}, {'ForeName': 'BeiBei', 'Initials': 'B', 'LastName': 'Kuang', 'Affiliation': 'The Institute for Mental Crisis Prevention and Intervention of College Students in Jiangsu Province, Nanjing Audit University, Nanjing, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Hu', 'Affiliation': 'Department of Psychology, Renmin University of China, Beijing, China.'}]",Frontiers in behavioral neuroscience,['10.3389/fnbeh.2020.00143']
3309,33061909,A Randomized Study of Food Pictures-Influenced Decision-Making Under Ambiguity in Individuals With Morbid Obesity.,"Background and Aims


In addition to craving responses to salient food cues, the anticipation of short-term rewarding consumption of palatable food may overrun the anticipation of long-term negative consequences of obesity. The present investigation addressed the potential interplay of food cravings and decision-making abilities in individuals with obesity.
Method


Study 1 included 107 bariatric surgery candidates with class 2/3 obesity (OB-group) and study 2 included 54 individuals with normal weight/pre-obesity (nonOB-group). In both studies, standardized questionnaires concerning food cravings, food addiction, and psychopathology were administered. A cue-reactivity paradigm was used to measure craving responses toward semi-individualized images of highly palatable, processed food/fruit (appetitive food cues) compared to images of raw vegetables (non-appetitive food cues). Decision-making was measured with a modified computerized version of the Iowa Gambling Task (IGT) with food pictures. Both groups were divided into two subgroups that were randomized to different IGT conditions. In one IGT condition the advantageous IGT card decks were covered by pictures of palatable, processed food or fruit and the disadvantageous decks by images of raw vegetables (= congruent condition), and in the other IGT condition  vice versa .
Results


Participants in the OB-group admitted on average higher craving responses toward palatable, processed food or fruit cues compared to pictures of raw vegetables. This was not the case in the nonOB-group. Contrary to our hypothesis, decision-making performance in both groups was worse when pictures of palatable, processed food or fruit were associated with advantageous IGT card decks compared to performance when those pictures were linked to the disadvantageous decks. The interference effect of food pictures processing on advantageous decision-making has been observed particularly in those individuals of the OB-group who exhibited high craving responses toward palatable, processed food cues or high levels of food addiction.
Discussion


The results indicate that food pictures processing interferes with decision-making, regardless of weight status. Opposed to the hypothesis, stronger tendencies to avoid than to approach pictures presenting processed, tasty food were observed. Further research should examine how cognitive avoidance tendencies toward processed, high energy food and approach tendencies toward healthy food can be transferred to real life situations.",2020,"Participants in the OB-group admitted on average higher craving responses toward palatable, processed food or fruit cues compared to pictures of raw vegetables.","['107 bariatric surgery candidates with class 2/3 obesity (OB-group) and study 2 included 54 individuals with normal weight/pre-obesity (nonOB-group', 'Individuals With Morbid Obesity', 'individuals with obesity']",['Food Pictures-Influenced Decision-Making'],"['food pictures processing interferes with decision-making, regardless of weight status', 'standardized questionnaires concerning food cravings, food addiction, and psychopathology']","[{'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C2712185', 'cui_str': 'Normal weight'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0028756', 'cui_str': 'Morbid obesity'}]","[{'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C0011109', 'cui_str': 'Decision making'}]","[{'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0011109', 'cui_str': 'Decision making'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0872380', 'cui_str': 'Food craving'}, {'cui': 'C4505163', 'cui_str': 'Food Addiction'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}]",,0.0185341,"Participants in the OB-group admitted on average higher craving responses toward palatable, processed food or fruit cues compared to pictures of raw vegetables.","[{'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Lescher', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Wegmann', 'Affiliation': 'General Psychology: Cognition and Center for Behavioral Addiction Research (CeBAR), University of Duisburg-Essen, Duisburg, Germany.'}, {'ForeName': 'Silke M', 'Initials': 'SM', 'LastName': 'Müller', 'Affiliation': 'General Psychology: Cognition and Center for Behavioral Addiction Research (CeBAR), University of Duisburg-Essen, Duisburg, Germany.'}, {'ForeName': 'Nora M', 'Initials': 'NM', 'LastName': 'Laskowski', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Wunder', 'Affiliation': 'Surgical Department, Clementinenhaus, Hannover, Germany.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Jiménez-Murcia', 'Affiliation': 'Department of Psychiatry, University Hospital Bellvitge-IDIBELL and CIBEROBN, Barcelona, Spain.'}, {'ForeName': 'Gregor R', 'Initials': 'GR', 'LastName': 'Szycik', 'Affiliation': 'Department of Psychiatry, Social Psychiatry and Psychotherapy, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'de Zwaan', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Müller', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, Hannover Medical School, Hannover, Germany.'}]",Frontiers in psychiatry,['10.3389/fpsyt.2020.00822']
3310,33062061,Quality of life after gastric bypass surgery in patients with type 2 diabetes: patients' experiences during 2 years of follow-up.,"Background


To examine the effects of gastric bypass surgery on health-related quality of life (HRQoL) in obese patients with type 2 diabetes, and to investigate their experiences of life adjustments using quantitative and qualitative methods.
Methods


Thirteen patients with type 2 diabetes and obesity, (body mass index, BMI > 30 kg/m 2 ), participating in a randomized clinical trial, completed this sub-study. HRQoL was evaluated before, and at 6 months and 2 years after gastric bypass surgery, using the RAND- 36-item health survey. At 2 years, interviews for in-depth analysis of HRQoL changes were performed.
Results


Significant improvement was observed from baseline to 6 months for 2 of the eight health concepts, general health, and emotional well-being. At 2 years, improvements were also seen in physical functioning, energy/fatigue, as well as sustained improvements in general health and emotional well-being. Multiple regression analyses showed mostly non-significant associations between the magnitude of decrease in weight, BMI, and HbA1c during follow-up and improvement in HRQoL. The analyses from qualitative interviews supported a common latent theme ""Finding a balance between the experience of the new body weight and self-confidence"".
Conclusions


The improved HRQoL after gastric bypass surgery in obese patients with type 2 diabetes was not explained specifically by the magnitude of weight loss, but rather by the participants achieving a state of union between body and consciousness. Trial registration  ClinicalTrials.gov Identifier NCT02729246. Date of registration 6 April 2016 - Retrospectively registered https://clinicaltrials.gov/ct2/show/NCT02729246?term=bariglykos&draw=2&rank=1.",2020,"At 2 years, improvements were also seen in physical functioning, energy/fatigue, as well as sustained improvements in general health and emotional well-being.","['obese patients with type 2 diabetes', 'Thirteen patients with type 2 diabetes and obesity, (body mass index, BMI\u2009>\u200930\xa0kg/m 2 ', 'patients with type 2 diabetes']",['gastric bypass surgery'],"['weight loss', 'general health and emotional well-being', 'physical functioning, energy/fatigue', 'health-related quality of life (HRQoL', 'HRQoL', 'weight, BMI, and HbA1c during follow-up and improvement in HRQoL', 'Quality of life']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}]",13.0,0.0506247,"At 2 years, improvements were also seen in physical functioning, energy/fatigue, as well as sustained improvements in general health and emotional well-being.","[{'ForeName': 'Petros', 'Initials': 'P', 'LastName': 'Katsogiannos', 'Affiliation': 'Departments of Medical Science, Clinical Diabetes and Metabolism Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Randell', 'Affiliation': 'School of Education, Health and Social Studies, Dalarna University, Falun, Sweden.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Sundbom', 'Affiliation': 'Department of Surgical Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Rosenblad', 'Affiliation': 'Departments of Medical Science, Clinical Diabetes and Metabolism Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Jan W', 'Initials': 'JW', 'LastName': 'Eriksson', 'Affiliation': 'Departments of Medical Science, Clinical Diabetes and Metabolism Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Janeth', 'Initials': 'J', 'LastName': 'Leksell', 'Affiliation': 'Departments of Medical Science, Clinical Diabetes and Metabolism Sciences, Uppsala University, Uppsala, Sweden.'}]",Diabetology & metabolic syndrome,['10.1186/s13098-020-00597-1']
3311,33062063,Prognostic role of a new index (multi inflammatory index) in patients with metastatic colorectal cancer: results from the randomized ITACa trial.,"Aims


We created a new index (Multi Inflammatory Index, MII) composed of an inflammatory index [neutrophil-to lymphocyte-ratio (NLR): MII-1; platelet-to-lymphocyte ratio (PLR): MII-2; or systemic immune-inflammation index (SII): MII-3] and C-reactive protein (CRP). Our aim was to evaluate the prognostic and/or predictive capacity of the MII in the randomized ITACa (Italian Trial in Advanced Colorectal Cancer) study on patients with metastatic colorectal cancer undergoing first-line chemotherapy.
Methods


Between November 2007 and March 2012, baseline NLR, PLR; SII and CRP were available for 131 patients, 66 receiving chemotherapy plus bevacizumab and 65 receiving chemotherapy alone.
Results


Patients with low (<25) MII-1 levels had a better outcome than those with high (⩾25) levels: median progression-free survival (PFS) was 12.4  versus  8.9 months [hazard ratio (HR) = 1.74, 95% confidence interval (CI) 1.21-2.51,  p  = 0.003] and median overall survival (OS) was 30.9 months  versus  15.0 months (HR = 2.05, 95% CI 1.40-3.02,  p  = 0.0002), respectively. Similar results were obtained for patients with low (<1424) MII-2 levels compared with those with high (⩾1424) levels: median PFS was 12.6  versus  8.9 months (HR = 1.95, 95% CI 1.35-2.82,  p  = 0.0004) and median OS was 32.4  versus  14.6 months, respectively (HR = 2.42, 95% CI 1.64-3.57,  p  < 0.0001). Patients with low (<6068) MII-3 levels had a longer median PFS and OS than those with high (⩾6068) levels: 12.6  versus  8.9 months (HR = 1.91, 95% CI 1.33-2.76,  p  = 0.005) and 30.9  versus 15.0 months (HR = 2.10, 95% CI 1.43-3.09,  p  = 0.0002), respectively. Following adjustment for clinical covariates, multivariate analysis confirmed all MII indexes as independent prognostic factors for predicting PFS and OS.
Conclusion


All MII indexes appear to be useful as prognostic markers.
Trial registration


ClinicalTrials.gov identifier: NCT01878422 (registration date: 07/06/2013) https://clinicaltrials.gov/ct2/show/NCT01878422.",2020,levels had a better outcome than those with high (⩾25) levels: median progression-free survival (PFS) was 12.4  versus  8.9 months [hazard ratio (HR) = ,"['patients with metastatic colorectal cancer', 'Patients with low (<25', 'patients with metastatic colorectal cancer undergoing first-line chemotherapy', 'Methods\n\n\nBetween November 2007 and March 2012']","['ITACa', 'chemotherapy plus bevacizumab', 'new index (multi inflammatory index']","['longer median PFS and OS', 'MII-1', 'inflammatory index [neutrophil-to lymphocyte-ratio (NLR', 'high (⩾25) levels: median progression-free survival (PFS', 'MII-1; platelet-to-lymphocyte ratio (PLR): MII-2; or systemic immune-inflammation index (SII): MII-3] and C-reactive protein (CRP', 'median OS', 'median overall survival (OS', 'median PFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.40103,levels had a better outcome than those with high (⩾25) levels: median progression-free survival (PFS) was 12.4  versus  8.9 months [hazard ratio (HR) = ,"[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Casadei Gardini', 'Affiliation': 'Division of Medical Oncology, Department of Medical and Surgical Sciences for Children and Adults, University Hospital of Modena, Italy.'}, {'ForeName': 'Emanuela', 'Initials': 'E', 'LastName': 'Scarpi', 'Affiliation': 'Unit of Biostatistics and Clinical Trials, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Via P. Maroncelli 40, Meldola, Forlì, 47014, Italy.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Valgiusti', 'Affiliation': 'Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.'}, {'ForeName': 'Manlio', 'Initials': 'M', 'LastName': 'Monti', 'Affiliation': 'Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Ruscelli', 'Affiliation': 'Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Matteucci', 'Affiliation': 'Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Bartolini', 'Affiliation': 'Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.'}, {'ForeName': 'Bernadette', 'Initials': 'B', 'LastName': 'Vertogen', 'Affiliation': 'Unit of Biostatistics and Clinical Trials, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.'}, {'ForeName': 'Flavia', 'Initials': 'F', 'LastName': 'Pagan', 'Affiliation': 'Unit of Biostatistics and Clinical Trials, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Rovesti', 'Affiliation': 'Division of Medical Oncology, Department of Medical and Surgical Sciences for Children and Adults, University Hospital of Modena, Italy.'}, {'ForeName': 'Giovanni Luca', 'Initials': 'GL', 'LastName': 'Frassineti', 'Affiliation': 'Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Passardi', 'Affiliation': 'Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.'}]",Therapeutic advances in medical oncology,['10.1177/1758835920958363']
3312,33062081,The Effect of Adding Neuromuscular Electrical Stimulation with Endurance and Resistance Training on Exercise Capacity and Balance in Patients with Chronic Obstructive Pulmonary Disease: A Randomized Controlled Trial.,"This study investigated the effectiveness of adding neuromuscular electrical stimulation (NMES) to endurance training (ET) and resistance training (RT) on exercise tolerance and balance in COPD patients. 42 patients were assigned randomly to the ET + RT + NMES group ( n  = 22) or ET + RT group ( n  = 20). Two training programs were performed including 72 sessions. The center of pressure (CoP) displacement in the mediolateral direction (CoPML), in the anteroposterior direction (CoPAP), and the center of pressure velocity (CoPV) were recorded using a stabilometric platform with eyes open (EO) and eyes closed (EC). Time up and go and Berg Balance Scale tests, 6-minute walking test (6MWT), and the maximal voluntary contraction (MVC) were measured before and after the intervention. The walking distance, the dyspnea, and the heart rate were improved after the training period ( p  < 0.001) for both groups ( p  < 0.05). The ET + RT + NMES group showed better improvement than the ET + RT group in terms of 6MWD. CoP ML , CoP AP , and CoP V  were significantly ( p  < 0.001;  p  < 0.05;  p  < 0.001, respectively) more improved in EO and EC conditions in the ET + RT + NMES group than the ET + RT group. BBS, TUG, and MVC values improved in both groups after the training ( p  < 0.001). The performances in TUG and MVC tests were significantly greater in the ET + RT + NMES group than those in the ET + RT group ( p  < 0.01;  p  < 0.001, respectively). Combining NMES, RT, and ET improves balance in patients with COPD.",2020,The ET + RT + NMES group showed better improvement than the ET + RT group in terms of 6MWD.,"['COPD patients', '42 patients', 'patients with COPD', 'Patients with Chronic Obstructive Pulmonary Disease']","['Neuromuscular Electrical Stimulation with Endurance and Resistance Training', 'neuromuscular electrical stimulation (NMES) to endurance training (ET) and resistance training (RT', 'NMES, RT, and ET', 'ET\u2009+\u2009RT', 'stabilometric platform with eyes open (EO) and eyes closed (EC', 'ET\u2009+\u2009RT\u2009+\u2009NMES']","['Exercise Capacity and Balance', 'exercise tolerance and balance', 'BBS, TUG, and MVC values', 'performances in TUG and MVC tests', 'Time up and go and Berg Balance Scale tests, 6-minute walking test (6MWT), and the maximal voluntary contraction (MVC', 'EO and EC conditions', 'walking distance, the dyspnea, and the heart rate', 'CoP ML , CoP AP , and CoP V']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0266574', 'cui_str': 'Ablepharon'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0587267', 'cui_str': 'Closed'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0162521', 'cui_str': 'Exercise tolerance'}, {'cui': 'C0398791', 'cui_str': 'Microcephaly, normal intelligence and immunodeficiency'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0056471', 'cui_str': 'creatinolfosfate'}]",42.0,0.0181182,The ET + RT + NMES group showed better improvement than the ET + RT group in terms of 6MWD.,"[{'ForeName': 'Amal', 'Initials': 'A', 'LastName': 'Acheche', 'Affiliation': ""Laboratoire de Recherche Physiologie de l'Exercice et Physiopathologie: de l'intégré au moléculaire « Biologie, Médecine et Santé » (LR19ES09), Faculté de Médecine de Sousse, Sousse 4002, Tunisia.""}, {'ForeName': 'Marwa', 'Initials': 'M', 'LastName': 'Mekki', 'Affiliation': ""Laboratoire de Recherche Physiologie de l'Exercice et Physiopathologie: de l'intégré au moléculaire « Biologie, Médecine et Santé » (LR19ES09), Faculté de Médecine de Sousse, Sousse 4002, Tunisia.""}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Paillard', 'Affiliation': ""Movement, Balance, Performance and Health Laboratory (EA 4445), University of Pau and des Pays de l'Adour, Pau 64012, France.""}, {'ForeName': 'Zouhair', 'Initials': 'Z', 'LastName': 'Tabka', 'Affiliation': ""Laboratoire de Recherche Physiologie de l'Exercice et Physiopathologie: de l'intégré au moléculaire « Biologie, Médecine et Santé » (LR19ES09), Faculté de Médecine de Sousse, Sousse 4002, Tunisia.""}, {'ForeName': 'Yassine', 'Initials': 'Y', 'LastName': 'Trabelsi', 'Affiliation': ""Laboratoire de Recherche Physiologie de l'Exercice et Physiopathologie: de l'intégré au moléculaire « Biologie, Médecine et Santé » (LR19ES09), Faculté de Médecine de Sousse, Sousse 4002, Tunisia.""}]",Canadian respiratory journal,['10.1155/2020/9826084']
3313,33062209,Patterns of change in physical functioning and posttraumatic stress disorder with cognitive processing therapy in a randomized controlled implementation trial.,"Background : Physical health concerns (e.g. chronic pain, fatigue) are common among clients with posttraumatic stress disorder (PTSD). Prior research has indicated that clients report improved physical functioning and fewer physical health symptoms after receiving Cognitive Processing Therapy (CPT) for PTSD. However, less is known about the impact of physical functioning on the clients' PTSD symptom improvement in CPT.  Objective : The current study examined the patterns of change of and between physical functioning and PTSD symptoms over the course of CPT among a diverse military, veteran, and community sample.  Method : We collected clients' ( N  = 188) physical functioning and PTSD symptom severity prior to and during CPT using the 12-Item Short Form Health Survey and the PTSD Checklist. We used multilevel modelling to 1) evaluate the impact of baseline physical functioning on the PTSD symptom trajectory, 2) examine the trajectory of physical functioning, and 3) assess the dynamics between physical functioning and PTSD symptoms over the course of CPT.  Results : Our multilevel analyses indicated that 1) physical functioning significantly improved for those with low levels of functioning prior to treatment, 2) poorer baseline physical functioning predicted slower improvements in PTSD symptoms, and 3) poorer physical functioning in one session predicted less PTSD symptom improvement by the next session.  Conclusions : Our findings demonstrate that while physical functioning can interfere with PTSD symptom improvement, physical functioning can also improve over the course of CPT. In light of the interconnected nature of physical health and PTSD symptoms, clinicians may need to attend to lower levels of physical functioning when providing CPT or other trauma-focused therapies. Future research to determine whether specific treatment adaptations may benefit such clients is needed.",2020,Prior research has indicated that clients report improved physical functioning and fewer physical health symptoms after receiving Cognitive Processing Therapy (CPT) for PTSD.,"['clients with posttraumatic stress disorder (PTSD', ""collected clients' ( N  =\xa0188) physical functioning and PTSD symptom severity prior to and during CPT using the 12-Item Short Form Health Survey and the PTSD Checklist""]","['cognitive processing therapy', 'Cognitive Processing Therapy (CPT', ' ']","['PTSD symptom improvement', 'physical functioning and fewer physical health symptoms', 'PTSD symptoms, and 3) poorer physical functioning']","[{'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0006938', 'cui_str': 'Captopril'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}]","[{'cui': 'C0025361', 'cui_str': 'Form of thinking'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0006938', 'cui_str': 'Captopril'}]","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205388', 'cui_str': 'Few'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}]",188.0,0.0150509,Prior research has indicated that clients report improved physical functioning and fewer physical health symptoms after receiving Cognitive Processing Therapy (CPT) for PTSD.,"[{'ForeName': 'Jiyoung', 'Initials': 'J', 'LastName': 'Song', 'Affiliation': 'National Center for PTSD, VA Palo Alto Healthcare System, Menlo Park, CA, USA.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Johnson', 'Affiliation': 'National Center for PTSD, VA Palo Alto Healthcare System, Menlo Park, CA, USA.'}, {'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Suvak', 'Affiliation': 'Department of Psychology, Suffolk University, Boston, MA, USA.'}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Shields', 'Affiliation': 'Royal Canadian Mounted Police, Westmount, QC, Canada.'}, {'ForeName': 'Jeanine E M', 'Initials': 'JEM', 'LastName': 'Lane', 'Affiliation': 'Department of Psychology, Ryerson University, Toronto, ON, Canada.'}, {'ForeName': 'Candice M', 'Initials': 'CM', 'LastName': 'Monson', 'Affiliation': 'Department of Psychology, Ryerson University, Toronto, ON, Canada.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Wiltsey-Stirman', 'Affiliation': 'National Center for PTSD, VA Palo Alto Healthcare System, Menlo Park, CA, USA.'}]",European journal of psychotraumatology,['10.1080/20008198.2020.1801166']
3314,33062311,Effect of Adding Losartan to Bevacizumab for Treating Diabetic Macular Edema.,"Introduction


Diabetic retinopathy is the most common cause of visual loss and blindness in the age group of 20 to 64 years. This study aimed to evaluate the efficacy of oral Losartan adjuvant therapy in combination with intravitreal injection of Bevacizumab in the treatment of diabetic macular edema.
Methods


In this randomized clinical trial, 61 eyes of 47 patients with normal blood pressure and diabetic macular edema and nonproliferative diabetic retinopathy were studied. Patients were randomly divided into Losartan ( n  = 33) and control ( n  = 28) groups. All patients received 3-6 intravitreal injections of Bevacizumab over 6 months. General examination including blood pressure and glycosylated hemoglobin measurements were performed in all patients. Complete ophthalmologic examination and macular OCT were performed at the first, third, and sixth months of treatment in all patients.
Results


The mean age of the patients studied was 57.1 ± 7.4 years and 37.7% of the patients were male. There was no significant difference between the two groups in terms of initial visual acuity, central macular thickness, and frequency of injections. There was no significant difference in visual acuity and central macular thickness between the two groups at the first, third, and sixth months of treatment. Age, frequency of injection, and initial macular thickness less than 450 microns were effective in patients' final visual acuity.
Conclusion


Short-term adjuvant treatment with Losartan in patients with diabetic macular edema and nonproliferative diabetic retinopathy has no greater effect than the standard treatment.",2020,"There was no significant difference in visual acuity and central macular thickness between the two groups at the first, third, and sixth months of treatment.","['Diabetic Macular Edema', '61 eyes of 47 patients with normal blood pressure and diabetic macular edema and nonproliferative diabetic retinopathy were studied', 'mean age of the patients studied was 57.1\u2009±\u20097.4 years and 37.7% of the patients were male', 'diabetic macular edema', 'patients with diabetic macular edema and nonproliferative diabetic retinopathy']","['Losartan', 'Losartan to Bevacizumab', 'oral Losartan adjuvant therapy', 'Bevacizumab']","['blood pressure and glycosylated hemoglobin measurements', 'initial visual acuity, central macular thickness, and frequency of injections', 'visual acuity and central macular thickness', 'Complete ophthalmologic examination and macular OCT']","[{'cui': 'C0730285', 'cui_str': 'Macular edema due to diabetes mellitus'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2712122', 'cui_str': 'Normal blood pressure'}, {'cui': 'C0004606', 'cui_str': 'Nonproliferative diabetic retinopathy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517858', 'cui_str': '7.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0126174', 'cui_str': 'Losartan'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0200149', 'cui_str': 'Ophthalmic examination and evaluation'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}]",47.0,0.0183979,"There was no significant difference in visual acuity and central macular thickness between the two groups at the first, third, and sixth months of treatment.","[{'ForeName': 'Fariba', 'Initials': 'F', 'LastName': 'Ghassemi', 'Affiliation': 'Department of Ophthalmology, Ophthalmology Research Center, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Abdulrahim', 'Initials': 'A', 'LastName': 'Amini', 'Affiliation': 'Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Yasemi', 'Affiliation': 'Poostchi Ophthalmology Research Center, Department of Ophthalmology, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Amin', 'Initials': 'A', 'LastName': 'Nabavi', 'Affiliation': 'Eye Research Center, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammadkarim', 'Initials': 'M', 'LastName': 'Johari', 'Affiliation': 'Poostchi Ophthalmology Research Center, Department of Ophthalmology, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",Journal of ophthalmology,['10.1155/2020/4528491']
3315,33062315,First Experience in Small Incision Lenticule Extraction with the Femto LDV Z8 and Lenticule Evaluation Using Scanning Electron Microscopy.,"Purpose


To evaluate the specifications and technique properties of the new Femto LDV Z8 in creating intrastromal refractive lenticules during small incision lenticule extraction (SMILE).
Methods


Six enucleated porcine eyeballs were equally divided into two groups (Femto LDV Z8 or VisuMax) and were randomly assigned to three experienced refractive surgeons who performed SMILE on each group. Five intraoperative time parameters and surgeons' satisfaction on the surgical procedure were compared between two groups. Postoperatively, the roughness of the lenticule surfaces and the irregularity of edges were observed by scanning electron microscopy (SEM) and were also compared between the two groups.
Results


Longer time on suction peak pressure, total laser application, and total surgery were spent in the Femto LDV Z8 group as compared with the VisuMax group. The Femto LDV Z8 group applied OCT scanning and offsetting before performing the laser procedure, which expended more time for these crucial steps. The widest range of surgeons' satisfaction scores was found in the step of lenticule interface identification of the Femto LDV Z8 group. The roughness scores of the anterior and posterior lenticule surfaces were statistically less in the Femto LDV Z8 group than in the VisuMax group (anterior, ×180,  p =0.039; anterior, ×250,  p =0.337; posterior, ×180,  p =0.006; and posterior, ×250,  p =0.007).
Conclusions


Femto LDV Z8 showed promising performances as a novel SMILE equipment for the correction of myopia. It has special and unique features for SMILE procedures, which need more learning and researching processes. With its low-energy high-frequency nJ-level laser system, the Femto LDV Z8 provided smoother lenticule surface than VisuMax.",2020,"The roughness scores of the anterior and posterior lenticule surfaces were statistically less in the Femto LDV Z8 group than in the VisuMax group (anterior, ×180,  p =0.039; anterior, ×250,  p =0.337; posterior, ×180,  p =0.006; and posterior, ×250,  p =0.007).
",['Methods\n\n\nSix enucleated porcine eyeballs'],[],"[""widest range of surgeons' satisfaction scores"", 'Longer time on suction peak pressure, total laser application, and total surgery', 'roughness of the lenticule surfaces and the irregularity of edges', 'roughness scores of the anterior and posterior lenticule surfaces']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0039005', 'cui_str': 'Suidae'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}]",[],"[{'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0038638', 'cui_str': 'Suction drainage'}, {'cui': 'C0445174', 'cui_str': 'Peak pressure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0205154', 'cui_str': 'Along edge'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}]",6.0,0.0204279,"The roughness scores of the anterior and posterior lenticule surfaces were statistically less in the Femto LDV Z8 group than in the VisuMax group (anterior, ×180,  p =0.039; anterior, ×250,  p =0.337; posterior, ×180,  p =0.006; and posterior, ×250,  p =0.007).
","[{'ForeName': 'Mengmeng', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'Hebei Ophthalmology Key Lab, Hebei Eye Hospital, Xingtai 054000, Hebei Province, China.'}, {'ForeName': 'Fengju', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': 'Beijing Tongren Eye Center, Beijing Tongren Hospital, Capital Medical University, Beijing Ohthalmology and Visual Sciences Key Lab, Beijing 100730, China.'}, {'ForeName': 'Christine Carole', 'Initials': 'CC', 'LastName': 'Copruz', 'Affiliation': 'Ifugao State University Eye Center, Alfonso Lista, Ifugao 3608, Philippines.'}, {'ForeName': 'Longhui', 'Initials': 'L', 'LastName': 'Han', 'Affiliation': 'Hebei Ophthalmology Key Lab, Hebei Eye Hospital, Xingtai 054000, Hebei Province, China.'}]",Journal of ophthalmology,['10.1155/2020/6751826']
3316,33062443,A strength-oriented exercise session required more recovery time than a power-oriented exercise session with equal work.,"The present randomized cross-over controlled study aimed to compare the rate of recovery from a strength-oriented exercise session vs. a power-oriented session with equal work. Sixteen strength-trained individuals conducted one strength-oriented session (five repetitions maximum (RM)) and one power-oriented session (50% of 5RM) in randomized order. Squat jump (SJ), countermovement jump (CMJ), 20-m sprint, and squat and bench press peak power and estimated 1RMs were combined with measures of rate of perceived exertion (RPE) and perceived recovery status (PRS), before, immediately after and 24 and 48 h after exercise. Both sessions induced trivial to moderate performance decrements in all variables. Small reductions in CMJ height were observed immediately after both the strength-oriented session (7 ± 6%) and power-oriented session (5 ± 5%). Between 24 and 48 h after both sessions CMJ and SJ heights and 20 m sprint were back to baseline. However, in contrast to the power-oriented session, recovery was not complete 48 h after the strength-oriented session, as indicated by greater impairments in CMJ eccentric and concentric peak forces, SJ rate of force development (RFD) and squat peak power. In agreement with the objective performance measurements, RPE and PRS ratings demonstrated that the strength-oriented session was experienced more strenuous than the power-oriented session. However, these subjective measurements agreed poorly with performance measurements at the individual level. In conclusion, we observed a larger degree of neuromuscular impairment and longer recovery times after a strength-oriented session than after a power-oriented session with equal total work, measured by both objective and subjective assessments. Nonetheless, most differences were small or trivial after either session. It appears necessary to combine several tests and within-test analyses (e.g., CMJ height, power and force) to reveal such differences. Objective and subjective assessments of fatigue and recovery cannot be used interchangeably; rather they should be combined to give a meaningful status for an individual in the days after a resistance exercise session.",2020,"However, in contrast to the power-oriented session, recovery was not complete 48 h after the strength-oriented session, as indicated by greater impairments in CMJ eccentric and concentric peak forces, SJ rate of force development (RFD) and squat peak power.",['Sixteen strength-trained individuals conducted one'],"['strength-oriented session (five repetitions maximum (RM)) and one power-oriented session (50% of 5RM', 'strength-oriented exercise session', 'strength-oriented exercise session vs. a power-oriented session with equal work']","['recovery time', 'CMJ eccentric and concentric peak forces, SJ rate of force development (RFD) and squat peak power', 'CMJ height', 'Squat jump (SJ), countermovement jump (CMJ), 20-m sprint, and squat and bench press peak power and estimated 1RMs were combined with measures of rate of perceived exertion (RPE) and perceived recovery status (PRS', 'objective performance measurements, RPE and PRS ratings']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0043227', 'cui_str': 'Working'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0439740', 'cui_str': 'Eccentric'}, {'cui': 'C0439744', 'cui_str': 'Concentric'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0454326', 'cui_str': 'Bench press'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",,0.0240027,"However, in contrast to the power-oriented session, recovery was not complete 48 h after the strength-oriented session, as indicated by greater impairments in CMJ eccentric and concentric peak forces, SJ rate of force development (RFD) and squat peak power.","[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Helland', 'Affiliation': 'Norwegian Olympic and Paralympic Committee and Confederation of Sports, Oslo, Norway.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Midttun', 'Affiliation': 'Norwegian Olympic and Paralympic Committee and Confederation of Sports, Oslo, Norway.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Saeland', 'Affiliation': 'Norwegian Olympic and Paralympic Committee and Confederation of Sports, Oslo, Norway.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Haugvad', 'Affiliation': 'Norwegian Olympic and Paralympic Committee and Confederation of Sports, Oslo, Norway.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Schäfer Olstad', 'Affiliation': 'Polar Electro Oy, Kempele, Finland.'}, {'ForeName': 'Paul Andre', 'Initials': 'PA', 'LastName': 'Solberg', 'Affiliation': 'Norwegian Olympic and Paralympic Committee and Confederation of Sports, Oslo, Norway.'}, {'ForeName': 'Gøran', 'Initials': 'G', 'LastName': 'Paulsen', 'Affiliation': 'Norwegian Olympic and Paralympic Committee and Confederation of Sports, Oslo, Norway.'}]",PeerJ,['10.7717/peerj.10044']
3317,33062627,Pharmacodynamic evaluation of YH4808 for  Helicobacter pylori  eradication in healthy subjects.,"YH4808 is a novel selective potassium-competitive acid blocker demonstrated to be safe and to have inhibitory effects against gastric acid secretion in previous studies. A randomized, open-label, multiple-dose, 3-treatment, 1-period, parallel design study was conducted to compare the  Helicobacter pylori  eradication rates and acid suppression capacities of three regimens in 60 healthy subjects with  H. pylori -positive, and the potential of YH4808 to replace proton-pump inhibitors (PPIs) in standard regimens for  H. pylori  eradication. Group 1 received YH4808, amoxicillin, and clarithromycin as a novel triple regimen, while Group 2 received YH4808 and amoxicillin only, and Group 3 received esomeprazole, amoxicillin, and clarithromycin, as the standard triple regimen.  H. pylori  eradication rates were 85.0% for Group 1, 25.0% for Group 2, and 83.3% for Group 3. Relative response rate between Group 1 and 3 was 1.02 (0.50-2.07; 95% CI, χ 2  test  p  = 0.8881). Furthermore, the novel triple regimen, YH4808, amoxicillin, and clarithromycin, stably inhibited acid secretion and maintained a gastric pH greater than 4 or 5 for 24 hours, which was comparable to the pH range in the standard triple regimen. However, the onset times of the YH4808 regimens were earlier than that for the regimens using esomeprazole. There were no differences in the incidences or severity of adverse events among the three groups. Overall, the novel triple regimen was safe and well-tolerated. YH4808 could replace PPIs in standard triple regimens used for  H. pylori  eradication.
Trial Registration


ClinicalTrials.gov Identifier: NCT01921647.",2020,"H. pylori  eradication rates were 85.0% for Group 1, 25.0% for Group 2, and 83.3% for Group 3.","['60 healthy subjects with  H. pylori -positive, and the potential of YH4808 to replace proton-pump inhibitors (PPIs) in standard regimens for  H. pylori  eradication', 'healthy subjects']","['esomeprazole', 'YH4808 and amoxicillin', 'esomeprazole, amoxicillin, and clarithromycin', 'YH4808, amoxicillin, and clarithromycin', 'amoxicillin, and clarithromycin']","['Relative response rate', 'safe and well-tolerated', 'incidences or severity of adverse events', 'H. pylori  eradication rates']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C4547142', 'cui_str': 'YH4808'}, {'cui': 'C0559956', 'cui_str': 'Replacement - action'}, {'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0937846', 'cui_str': 'Esomeprazole'}, {'cui': 'C4547142', 'cui_str': 'YH4808'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0055856', 'cui_str': 'Clarithromycin'}]","[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}]",60.0,0.0227467,"H. pylori  eradication rates were 85.0% for Group 1, 25.0% for Group 2, and 83.3% for Group 3.","[{'ForeName': 'Hyeonsoo', 'Initials': 'H', 'LastName': 'Park', 'Affiliation': 'Department of Clinical Pharmacology, Severance Hospital, Yonsei University College of Medicine, Seoul 03722, Korea.'}, {'ForeName': 'Choon Ok', 'Initials': 'CO', 'LastName': 'Kim', 'Affiliation': 'Department of Clinical Pharmacology, Severance Hospital, Yonsei University College of Medicine, Seoul 03722, Korea.'}, {'ForeName': 'Mikyung', 'Initials': 'M', 'LastName': 'Kim', 'Affiliation': 'Clinical Development Department, R&D Division, Yuhan Corporation, Seoul 03722, Korea.'}, {'ForeName': 'Yeji', 'Initials': 'Y', 'LastName': 'Lim', 'Affiliation': 'Clinical Development Department, R&D Division, Yuhan Corporation, Seoul 03722, Korea.'}, {'ForeName': 'Woo Yul', 'Initials': 'WY', 'LastName': 'Lee', 'Affiliation': 'Department of Clinical Pharmacology, Severance Hospital, Yonsei University College of Medicine, Seoul 03722, Korea.'}, {'ForeName': 'Sukyong', 'Initials': 'S', 'LastName': 'Yoon', 'Affiliation': 'Department of Clinical Pharmacology, Severance Hospital, Yonsei University College of Medicine, Seoul 03722, Korea.'}, {'ForeName': 'Min Soo', 'Initials': 'MS', 'LastName': 'Park', 'Affiliation': 'Department of Clinical Pharmacology, Severance Hospital, Yonsei University College of Medicine, Seoul 03722, Korea.'}]",Translational and clinical pharmacology,['10.12793/tcp.2020.28.e16']
3318,33062754,Improvement of osteoporosis-related behaviors in female students based on trans theoretical model.,"BACKGROUND


Osteoporosis is one of the major problems associated with aging and is more common among women than men. This study was designed to modify osteoporosis-related behaviors in female students based on the transtheoretical model (TTM).
MATERIALS AND METHODS


This quasi-experimental study was conducted on female secondary school students. The sample size was determined 100 by using Altman's nomogram, including 50 cases and 50 controls. Participants were completed the Demographic Information and Osteoporosis-Related Behavior Questionnaire based on TTM. Evaluation of the data showed that each participant was at what stage of change in physical activity and preventive dietary behavior of osteoporosis. The content of the training package was designed, and for the intervention group, 2-h training sessions were held weekly by the instructor in accordance with the stage of change for 2 months, and the booklet was provided with the appropriate contents of the stage of change. Three months after the completion of training, the questionnaires were completed by intervention and control groups. Statistical analysis was performed using SPSS 23 software.
RESULTS


Concerning the stages of change in physical activity and nutrition, a significant difference was before and after the intervention in the intervention group ( P  < 0.001), while no significant difference was observed in the control group. After the intervention, there was a significant difference in the self-efficacy and some subconstruct of processes of change, but there wasnot a significant difference in the decisional balance.
CONCLUSION


Educational intervention based on TTM has been successful in achieving the goal of modifying osteoporosis-related behaviors in female students. The results of this study can be used by health planners to plan and implement health promotion interventions that will undoubtedly help reduce the burden of disease.",2020,"After the intervention, there was a significant difference in the self-efficacy and some subconstruct of processes of change, but there wasnot a significant difference in the decisional balance.
","['female students based on the transtheoretical model (TTM', 'women than men', 'female secondary school students', 'female students']",['Educational intervention based on TTM'],"['Demographic Information and Osteoporosis-Related Behavior Questionnaire based on TTM', 'decisional balance', 'self-efficacy', 'physical activity and preventive dietary behavior of osteoporosis']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0036530', 'cui_str': 'Secondary school'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]",,0.025119,"After the intervention, there was a significant difference in the self-efficacy and some subconstruct of processes of change, but there wasnot a significant difference in the decisional balance.
","[{'ForeName': 'Vahid Kohpeima', 'Initials': 'VK', 'LastName': 'Jahromi', 'Affiliation': 'Research Center for Social Determinants of Health, Jahrom University of Medical Sciences, Jahrom, Iran.'}, {'ForeName': 'Sepide Bahlouli', 'Initials': 'SB', 'LastName': 'Ghashghaei', 'Affiliation': 'Research Center for Social Determinants of Health, Jahrom University of Medical Sciences, Jahrom, Iran.'}, {'ForeName': 'Nader', 'Initials': 'N', 'LastName': 'Sharifi', 'Affiliation': 'Research Center for Social Determinants of Health, Jahrom University of Medical Sciences, Jahrom, Iran.'}]",Journal of education and health promotion,['10.4103/jehp.jehp_213_20']
3319,33031652,Effect of Hydroxychloroquine in Hospitalized Patients with Covid-19.,"BACKGROUND


Hydroxychloroquine and chloroquine have been proposed as treatments for coronavirus disease 2019 (Covid-19) on the basis of in vitro activity and data from uncontrolled studies and small, randomized trials.
METHODS


In this randomized, controlled, open-label platform trial comparing a range of possible treatments with usual care in patients hospitalized with Covid-19, we randomly assigned 1561 patients to receive hydroxychloroquine and 3155 to receive usual care. The primary outcome was 28-day mortality.
RESULTS


The enrollment of patients in the hydroxychloroquine group was closed on June 5, 2020, after an interim analysis determined that there was a lack of efficacy. Death within 28 days occurred in 421 patients (27.0%) in the hydroxychloroquine group and in 790 (25.0%) in the usual-care group (rate ratio, 1.09; 95% confidence interval [CI], 0.97 to 1.23; P = 0.15). Consistent results were seen in all prespecified subgroups of patients. The results suggest that patients in the hydroxychloroquine group were less likely to be discharged from the hospital alive within 28 days than those in the usual-care group (59.6% vs. 62.9%; rate ratio, 0.90; 95% CI, 0.83 to 0.98). Among the patients who were not undergoing mechanical ventilation at baseline, those in the hydroxychloroquine group had a higher frequency of invasive mechanical ventilation or death (30.7% vs. 26.9%; risk ratio, 1.14; 95% CI, 1.03 to 1.27). There was a small numerical excess of cardiac deaths (0.4 percentage points) but no difference in the incidence of new major cardiac arrhythmia among the patients who received hydroxychloroquine.
CONCLUSIONS


Among patients hospitalized with Covid-19, those who received hydroxychloroquine did not have a lower incidence of death at 28 days than those who received usual care. (Funded by UK Research and Innovation and National Institute for Health Research and others; RECOVERY ISRCTN number, ISRCTN50189673; ClinicalTrials.gov number, NCT04381936.).",2020,"Death within 28 days occurred in 421 patients (27.0%) in the hydroxychloroquine group and in 790 (25.0%) in the usual-care group (rate ratio, 1.09; 95% confidence interval [CI], 0.97 to 1.23; P = 0.15).","['patients hospitalized with Covid-19, we randomly assigned 1561 patients to receive', 'coronavirus disease 2019 ', 'Hospitalized Patients with Covid-19', 'patients hospitalized with Covid-19']","['hydroxychloroquine', 'hydroxychloroquine and 3155 to receive usual care', 'Hydroxychloroquine and chloroquine', 'Hydroxychloroquine', 'usual care']","['cardiac deaths', 'death', '28-day mortality', 'frequency of invasive mechanical ventilation or death', 'Death', 'incidence of new major cardiac arrhythmia', 'hospital alive']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0008269', 'cui_str': 'Chloroquine'}]","[{'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C2584946', 'cui_str': 'Alive'}]",1561.0,0.344094,"Death within 28 days occurred in 421 patients (27.0%) in the hydroxychloroquine group and in 790 (25.0%) in the usual-care group (rate ratio, 1.09; 95% confidence interval [CI], 0.97 to 1.23; P = 0.15).","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Horby', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Mafham', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Linsell', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Bell', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Staplin', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Jonathan R', 'Initials': 'JR', 'LastName': 'Emberson', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Wiselka', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Ustianowski', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Einas', 'Initials': 'E', 'LastName': 'Elmahi', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Prudon', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Whitehouse', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Felton', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Williams', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Jakki', 'Initials': 'J', 'LastName': 'Faccenda', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Underwood', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'J Kenneth', 'Initials': 'JK', 'LastName': 'Baillie', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Lucy C', 'Initials': 'LC', 'LastName': 'Chappell', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Saul N', 'Initials': 'SN', 'LastName': 'Faust', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Jaki', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Jeffery', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Wei Shen', 'Initials': 'WS', 'LastName': 'Lim', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Montgomery', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Rowan', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Tarning', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Watson', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'White', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Edmund', 'Initials': 'E', 'LastName': 'Juszczak', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Haynes', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Martin J', 'Initials': 'MJ', 'LastName': 'Landray', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}]",The New England journal of medicine,['10.1056/NEJMoa2022926']
3320,33045448,Evaluation of the effect of trans-vaginal ovarian needle punctures on women with polycystic ovary syndrome.,"OBJECTIVE


Evaluation of the effectiveness of ultrasound-guided trans-vaginal ovarian needle punctures on improving the management of women with polycystic ovary syndrome resistant to clomiphene citrate.
METHODS


This was a randomized clinical trial conducted in a tertiary Hospital, from June 2016 to December 2018. We recruited twenty- seven women with resistant PCOS with either primary or secondary infertility. They were randomly assigned into two groups. Group one included patients who had a trial of induction using aromatase inhibitors (Letrozol 2.5 mg twice daily from day 2 of the cycle and for 5 days) and FSH administered with 75 IU daily from cycle day 3 and maintained for up to the 14th day of the cycle. Group two included patients who had transvaginal ovarian puncture prior to induction with AIs and gonadotropins. Folliculometery was done starting from day 9 of the cycle. When the follicle reaches a size of 18-25 mm, HCG was given to enhance ovulation.
RESULTS


There was a significant improvement in the hormonal profile (serum LH, FSH, and testosterone with a p- value of 0.0001, 0.007, and 0.0001 respectively) in the study group after one month of treatment. The overall number of ovulatory cycles was significantly higher in the study group than the control group [84 % (62/74), 62.8 % (49/78), p- value 0.006 respectively]. The cumulative pregnancy rates were significantly higher in the study group [33.3 % (9/27)]. No complications related to the procedure were reported.
CONCLUSION


transvaginal ovarian needle puncture is a safe and effective procedure.",2020,"There was a significant improvement in the hormonal profile (serum LH, FSH, and testosterone with a p- value of 0.0001, 0.007, and 0.0001 respectively) in the study group after one month of treatment.","['women with polycystic ovary syndrome', 'a tertiary Hospital, from June 2016 to December 2018', 'women with polycystic ovary syndrome resistant to clomiphene citrate', 'Group one included patients who had a trial of induction using', 'seven women with resistant PCOS with either primary or secondary infertility']","['HCG', 'trans-vaginal ovarian needle punctures', 'transvaginal ovarian puncture prior to induction with AIs and gonadotropins', 'ultrasound-guided trans-vaginal ovarian needle punctures', 'transvaginal ovarian needle puncture', 'aromatase inhibitors (Letrozol 2.5\u2009mg twice daily from day 2 of the cycle and for 5 days) and FSH']","['overall number of ovulatory cycles', 'hormonal profile (serum LH, FSH, and testosterone with a p- value', 'cumulative pregnancy rates']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0546859', 'cui_str': 'Clomiphene citrate'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0269230', 'cui_str': 'Secondary female infertility'}]","[{'cui': 'C1141639', 'cui_str': 'Human chorionic gonadotropin'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0175672', 'cui_str': 'Vaginal approach'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0018061', 'cui_str': 'Gonadotropin'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0593802', 'cui_str': 'Aromatase inhibitor'}, {'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0202022', 'cui_str': 'Follicle stimulating hormone measurement'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0429470', 'cui_str': 'Ovulatory'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0202022', 'cui_str': 'Follicle stimulating hormone measurement'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}]",27.0,0.103873,"There was a significant improvement in the hormonal profile (serum LH, FSH, and testosterone with a p- value of 0.0001, 0.007, and 0.0001 respectively) in the study group after one month of treatment.","[{'ForeName': 'Khaled A', 'Initials': 'KA', 'LastName': 'Atwa', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Suez Canal University, Round Road, Ismailia, Egypt. Electronic address: kh_atwa@hotmail.com.'}, {'ForeName': 'Mohamed M', 'Initials': 'MM', 'LastName': 'Farrag', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Suez Canal University, Round Road, Ismailia, Egypt. Electronic address: mouselhy@hotmail.com.'}, {'ForeName': 'Moamen M', 'Initials': 'MM', 'LastName': 'El-Sayed', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Suez Canal University, Round Road, Ismailia, Egypt. Electronic address: mo2mengomaa@yahoo.com.'}, {'ForeName': 'Omima T', 'Initials': 'OT', 'LastName': 'Taha', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Suez Canal University, Round Road, Ismailia, Egypt. Electronic address: omimatharwat@yahoo.com.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Elprince', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Suez Canal University, Round Road, Ismailia, Egypt. Electronic address: prince.ma939@yahoo.com.'}]",Journal of gynecology obstetrics and human reproduction,['10.1016/j.jogoh.2020.101937']
3321,33045501,Changes in fetoplacental Doppler indices following intrapartum maternal sildenafil citrate treatment.,"OBJECTIVE


Uterine contractions during labour can result in a 60 % decline in fetoplacental perfusion, predisposing the fetus to hypoxic brain injury. Sildenafil citrate (SC) has shown promise in increasing uteroplacental perfusion as well as reducing the risk of operative birth for intrapartum fetal compromise (IFC). The aim of this study was to investigate the effect of intrapartum SC administration on fetoplacental blood flow indices.
METHODS


This was a subgroup analysis from an earlier Phase II double blind randomized controlled trial; assessing the effect of intrapartum SC administration (50 mg orally 8 -hly in labour) compared to placebo for the reduction of operative birth for IFC. An ultrasound scan measuring fetoplacental Doppler indices was performed prior to and 1-4 h after the administration of the first treatment dose.
RESULTS


Of the 300 women randomized to the main study, pre-treatment ultrasound scans were performed in 261 participants who received the study medication; paired pre- and post-treatment scans were performed in 70 (26.8 %). SC resulted in an increase in the middle cerebral artery pulsatility index (PI) z-score [+0.08 (1.35) vs.-0.12 (1.15)], a decline in the umbilical artery-PI z-score [-0.07 (0.96) vs. + 0.04 (1.25)] and an increase in the cerebroplacental ratio [MCA-PI/UA-PI] (CPR) z-score [+0.10 (1.13) vs.-0.26 (1.14)] although these failed to reach statistical significance. Amongst those with a pre-treatment CPR above the 5th centile, SC significantly reduced the risk of operative birth for IFC compared to placebo [logrank p = 0.02; hazards ratio 0.48, 95 % CI 0.29-0.77, p = 0.003].
CONCLUSION


Although the differences in Doppler indices pre- and post- SC treatment were non-significant, there was a clear trend towards a reduction in the UA PI, a corresponding increase in the MCA PI and a rise in post treatment CPR values suggesting potential improvement in fetoplacental Dopplers with intrapartum SC treatment. However this study was limited by the small sample size. The results of this hypothesis generating study suggest that it may be possible to stratify women that would most benefit from this intervention based upon their pre-labour CPR.",2020,"Amongst those with a pre-treatment CPR above the 5th centile, SC significantly reduced the risk of operative birth for IFC compared to placebo [logrank p = 0.02; hazards ratio 0.48, 95 % CI 0.29-0.77, p = 0.003].
",['300 women randomized to the main study'],"['intrapartum SC administration (50\u2009mg orally 8\u2009-hly in labour', 'placebo', 'SC', 'Sildenafil citrate (SC', 'intrapartum SC']","['fetoplacental blood flow indices', 'cerebroplacental ratio', 'risk of operative birth for IFC', 'middle cerebral artery pulsatility index (PI) z-score', 'fetoplacental Doppler indices', 'umbilical artery-PI z-score']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0456337', 'cui_str': 'Intrapartum'}, {'cui': 'C0724693', 'cui_str': 'Sildenafil citrate'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0456337', 'cui_str': 'Intrapartum'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0149566', 'cui_str': 'Structure of middle cerebral artery'}, {'cui': 'C0429863', 'cui_str': 'Pulsatility index, arterial velocity waveform'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0554756', 'cui_str': 'Doppler studies'}, {'cui': 'C0041632', 'cui_str': 'Structure of umbilical artery'}]",300.0,0.176329,"Amongst those with a pre-treatment CPR above the 5th centile, SC significantly reduced the risk of operative birth for IFC compared to placebo [logrank p = 0.02; hazards ratio 0.48, 95 % CI 0.29-0.77, p = 0.003].
","[{'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Turner', 'Affiliation': 'Mater Research Institute, University of Queensland, Level 3 Aubigny Place, Raymond Terrace, South Brisbane, Queensland, 4101, Australia; Faculty of Medicine, University of Queensland, Whitty Building, Annerley Road, South Brisbane, Queensland, 4101, Australia.'}, {'ForeName': 'Liam', 'Initials': 'L', 'LastName': 'Dunn', 'Affiliation': 'Mater Research Institute, University of Queensland, Level 3 Aubigny Place, Raymond Terrace, South Brisbane, Queensland, 4101, Australia.'}, {'ForeName': 'Sailesh', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': 'Mater Research Institute, University of Queensland, Level 3 Aubigny Place, Raymond Terrace, South Brisbane, Queensland, 4101, Australia; Faculty of Medicine, University of Queensland, Whitty Building, Annerley Road, South Brisbane, Queensland, 4101, Australia. Electronic address: sailesh.kumar@mater.uq.edu.au.'}]","European journal of obstetrics, gynecology, and reproductive biology",['10.1016/j.ejogrb.2020.09.042']
3322,33046136,The Janus kinase 1/2 inhibitor baricitinib reduces biomarkers of joint destruction in moderate to severe rheumatoid arthritis.,"BACKGROUND


Tissue released blood-based biomarkers can provide insight into drug mode of action and response. To understand the changes in extracellular matrix turnover, we analyzed biomarkers associated with joint tissue turnover from a phase 3, randomized, placebo-controlled study of baricitinib in patients with active rheumatoid arthritis (RA).
METHODS


Serum biomarkers associated with synovial inflammation (C1M, C3M, and C4M), cartilage degradation (C2M), bone resorption (CTX-I), and bone formation (osteocalcin) were analyzed at baseline, and weeks 4 and 12, from a subgroup of patients (n = 240) randomized to placebo or 2-mg or 4-mg baricitinib (RA-BUILD, NCT01721057). Mixed-model repeated measure was used to identify biomarkers altered by baricitinib. The relationship between changes in biomarkers and clinical measures was evaluated using correlation analysis.
RESULTS


Treatment arms were well balanced for baseline biomarkers, demographics, and disease activity. At week 4, baricitinib 4-mg significantly reduced C1M from baseline by 21% compared to placebo (p < 0.01); suppression was sustained at week 12 (27%, p < 0.001). Baricitinib 4-mg reduced C3M and C4M at week 4 by 14% and 12% compared to placebo, respectively (p < 0.001); they remained reduced by 16% and 11% at week 12 (p < 0.001). In a pooled analysis including all treatment arms, patients with the largest reduction (upper 25% quartile) in C1M, C3M, and C4M by week 12 had significantly greater clinical improvement in the Simplified Disease Activity Index at week 12 compared to patients with the smallest reduction (lowest 25% quartile).
CONCLUSION


Baricitinib treatment resulted in reduced circulating biomarkers associated with joint tissue destruction as well as concomitant RA clinical improvement.
TRIAL REGISTRATION


ClinicalTrials.gov NCT01721057 ; date of registration: November 1, 2012.",2020,"At week 4, baricitinib 4-mg significantly reduced C1M from baseline by 21% compared to placebo (p < 0.01); suppression was sustained at week 12 (27%, p < 0.001).",['patients with active rheumatoid arthritis (RA'],['placebo'],"['C1M', 'baseline biomarkers, demographics, and disease activity', 'C3M and C4M', 'Simplified Disease Activity Index', 'synovial inflammation (C1M, C3M, and C4M), cartilage degradation (C2M), bone resorption (CTX-I), and bone formation (osteocalcin']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0007301', 'cui_str': 'Cartilage tissue'}, {'cui': 'C0243125', 'cui_str': 'degradation'}, {'cui': 'C0005974', 'cui_str': 'Bone resorption'}, {'cui': 'C0631180', 'cui_str': 'C-telopeptide'}, {'cui': 'C0029433', 'cui_str': 'Bone formation'}, {'cui': 'C0029419', 'cui_str': 'Osteocalcin'}]",,0.163022,"At week 4, baricitinib 4-mg significantly reduced C1M from baseline by 21% compared to placebo (p < 0.01); suppression was sustained at week 12 (27%, p < 0.001).","[{'ForeName': 'Christian S', 'Initials': 'CS', 'LastName': 'Thudium', 'Affiliation': 'Nordic Bioscience, Biomarkers and Research, Herlev Hovedgade 205-207, DK-2730, Herlev, Denmark. cst@nordicbio.com.'}, {'ForeName': 'Anne C', 'Initials': 'AC', 'LastName': 'Bay-Jensen', 'Affiliation': 'Nordic Bioscience, Biomarkers and Research, Herlev Hovedgade 205-207, DK-2730, Herlev, Denmark.'}, {'ForeName': 'Suntara', 'Initials': 'S', 'LastName': 'Cahya', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Ernst R', 'Initials': 'ER', 'LastName': 'Dow', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Morten A', 'Initials': 'MA', 'LastName': 'Karsdal', 'Affiliation': 'Nordic Bioscience, Biomarkers and Research, Herlev Hovedgade 205-207, DK-2730, Herlev, Denmark.'}, {'ForeName': 'Alisa E', 'Initials': 'AE', 'LastName': 'Koch', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Wenling', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Benschop', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}]",Arthritis research & therapy,['10.1186/s13075-020-02340-7']
3323,33046213,Dopaminergic and opioidergic regulation during anticipation and consumption of social and nonsocial rewards.,"The observation of animal orofacial and behavioral reactions has played a fundamental role in research on reward but is seldom assessed in humans. Healthy volunteers (N = 131) received 400 mg of the dopaminergic antagonist amisulpride, 50 mg of the opioidergic antagonist naltrexone, or placebo. Subjective ratings, physical effort, and facial reactions to matched primary social (affective touch) and nonsocial (food) rewards were assessed. Both drugs resulted in lower physical effort and greater negative facial reactions during reward anticipation, especially of food rewards. Only opioidergic manipulation through naltrexone led to a reduction in positive facial reactions to liked rewards during reward consumption. Subjective ratings of wanting and liking were not modulated by either drug. Results suggest that facial reactions during anticipated and experienced pleasure rely on partly different neurochemical systems, and also that the neurochemical bases for food and touch rewards are not identical.",2020,Only opioidergic manipulation through naltrexone led to a reduction in positive facial reactions to liked rewards during reward consumption.,['Healthy volunteers (N = 131'],"['dopaminergic antagonist amisulpride, 50 mg of the opioidergic antagonist naltrexone, or placebo', 'naltrexone']","['Subjective ratings, physical effort, and facial reactions to matched primary social (affective touch) and nonsocial (food) rewards', 'positive facial reactions', 'Subjective ratings of wanting and liking', 'lower physical effort and greater negative facial reactions']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0242702', 'cui_str': 'Dopamine receptor antagonist'}, {'cui': 'C0103045', 'cui_str': 'Amisulpride'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0031807', 'cui_str': 'Physical Effort'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0152054', 'cui_str': 'Touch'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1444647', 'cui_str': 'Wanted'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0205160', 'cui_str': 'Negative'}]",,0.0526814,Only opioidergic manipulation through naltrexone led to a reduction in positive facial reactions to liked rewards during reward consumption.,"[{'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Korb', 'Affiliation': 'Department of Psychology, University of Essex, Colchester, United Kingdom.'}, {'ForeName': 'Sebastian J', 'Initials': 'SJ', 'LastName': 'Götzendorfer', 'Affiliation': 'Department of Cognition, Emotion and Methods in Psychology, University of Vienna, Vienna, Austria.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Massaccesi', 'Affiliation': 'Department of Clinical and Health Psychology, University of Vienna, Vienna, Austria.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Sezen', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Graf', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Matthäus', 'Initials': 'M', 'LastName': 'Willeit', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Eisenegger', 'Affiliation': 'Department of Cognition, Emotion and Methods in Psychology, University of Vienna, Vienna, Austria.'}, {'ForeName': 'Giorgia', 'Initials': 'G', 'LastName': 'Silani', 'Affiliation': 'Department of Clinical and Health Psychology, University of Vienna, Vienna, Austria.'}]",eLife,['10.7554/eLife.55797']
3324,33046475,Effects of a power strength training using elastic resistance exercises on the motor and non-motor symptoms in patients with Parkinson's disease H&Y 1-3: study protocol for a randomised controlled trial (PARK-BAND Study).,"INTRODUCTION


Parkinson's disease (PD) is the second most common neurodegenerative disorder in Brazil. Physical activity is a complementary intervention in managing inherent declines associated with the disease like strength, balance, gait, and functionality and benefit health-related outcomes. Here, we report the PARK-BAND Study protocol, which aims to investigate potential benefits of power training using elastic devices in participants with PD. Our intervention will be provided in patients with PD using elastic devices like elastic bands and tubes. Therefore, we used the term Park from Parkinson's disease and band from elastic bands.
METHODS AND ANALYSIS


This randomised single-blind single-centre two-arm parallel, superiority trial will include 50 participants with PD attending the clinical setting. Those who meet the eligibility criteria and provide consent to participate will be randomised in a 1:1 ratio to either the exercise group, which will receive power training programme or the health education group, which will receive the education programme. Randomisation will be performed by permuted block randomisation with a block size of eight. Both groups will receive a 12-week intervention. The exercise group will have two sessions per week and the health education group will have one session per week. Changes from baseline in bradykinesia, as assessed by the Unified Parkinson's Disease Rating Scale motor examination subscore and physical functional performance, will be the primary outcomes. Secondary outcomes include other neurological, neurophysiological and physical variables, as well as the quality of life, depression, cognition, sleep quality and disturbances, assessed before and after interventions. We hypothesise that the exercise group will have greater improvement in primary and secondary outcomes than the health education group.
ETHICS AND DISSEMINATION


The study is approved by the Research Ethics Committee of Hospital Universitário Walter Cantidio and all participants will provide their written informed consent (register number 91075318.1.0000.5045).Trial results will be disseminated via peer reviewed journal articles and conference presentations, reports for organisations involved with PD and for participants.
TRIAL REGISTRATION NUMBER


Registro Brasileiro de Ensaios Clínicos Registry (RBR-5w2sqt); Pre-results.",2020,"Changes from baseline in bradykinesia, as assessed by the Unified Parkinson's Disease Rating Scale motor examination subscore and physical functional performance, will be the primary outcomes.","['50 participants with PD attending the clinical setting', ""patients with Parkinson's disease H&Y 1-3"", 'participants with PD']","['power training using elastic devices', 'power training programme or the health education group, which will receive the education programme', 'power strength training using elastic resistance exercises']","[""Unified Parkinson's Disease Rating Scale motor examination subscore and physical functional performance"", 'motor and non-motor symptoms', 'neurological, neurophysiological and physical variables, as well as the quality of life, depression, cognition, sleep quality and disturbances, assessed before and after interventions']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0221839', 'cui_str': 'Orthodontic band, elastic'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0150375', 'cui_str': 'Group education'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C4704690', 'cui_str': 'Physical Functional Performance'}, {'cui': 'C0426980', 'cui_str': 'Motor symptoms'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",50.0,0.0963442,"Changes from baseline in bradykinesia, as assessed by the Unified Parkinson's Disease Rating Scale motor examination subscore and physical functional performance, will be the primary outcomes.","[{'ForeName': 'Danielle Pessoa', 'Initials': 'DP', 'LastName': 'Lima', 'Affiliation': 'Geriatric Division, Universidade Federal do Ceará, Hospital Universitário Walter Cantídio, Fortaleza, Brazil dra.daniellelima@gmail.com.'}, {'ForeName': 'Samuel Brito', 'Initials': 'SB', 'LastName': 'de Almeida', 'Affiliation': 'Clinical Research Unit, Universidade Federal do Ceará, Hospital Universitário Walter Cantídio, Fortaleza, Brazil.'}, {'ForeName': 'Janine de Carvalho', 'Initials': 'JC', 'LastName': 'Bonfadini', 'Affiliation': 'Clinical Research Unit, Universidade Federal do Ceará, Hospital Universitário Walter Cantídio, Fortaleza, Brazil.'}, {'ForeName': 'Emmanuelle Silva Tavares', 'Initials': 'EST', 'LastName': 'Sobreira', 'Affiliation': 'Clinical Research Unit, Universidade Federal do Ceará, Hospital Universitário Walter Cantídio, Fortaleza, Brazil.'}, {'ForeName': 'Patrícia Gomes', 'Initials': 'PG', 'LastName': 'Damasceno', 'Affiliation': 'Division of Neurology, Universidade Federal do Ceará, Hospital Universitário Walter Cantídio, Fortaleza, Brazil.'}, {'ForeName': 'Antonio Brazil', 'Initials': 'AB', 'LastName': 'Viana Júnior', 'Affiliation': 'Clinical Research Unit, Universidade Federal do Ceará, Hospital Universitário Walter Cantídio, Fortaleza, Brazil.'}, {'ForeName': 'Madeleine Sales', 'Initials': 'MS', 'LastName': 'de Alencar', 'Affiliation': 'Geriatric Division, Universidade Federal do Ceará, Hospital Universitário Walter Cantídio, Fortaleza, Brazil.'}, {'ForeName': 'João Rafael Gomes', 'Initials': 'JRG', 'LastName': 'de Luna', 'Affiliation': 'Geriatric Division, Universidade Federal do Ceará, Hospital Universitário Walter Cantídio, Fortaleza, Brazil.'}, {'ForeName': 'Pedro Gustavo Barros', 'Initials': 'PGB', 'LastName': 'Rodrigues', 'Affiliation': 'Medical School, Universidade Federal do Ceará, Hospital Universitário Walter Cantídio, Fortaleza, Brazil.'}, {'ForeName': 'Isabelle de Sousa', 'Initials': 'IS', 'LastName': 'Pereira', 'Affiliation': 'Medical School, Universidade Federal do Ceará, Hospital Universitário Walter Cantídio, Fortaleza, Brazil.'}, {'ForeName': 'André Luis de Castro', 'Initials': 'ALC', 'LastName': 'Gadelha', 'Affiliation': 'Psychology School, Universidade de Fortaleza, Centro de Ciências da Saúde, Fortaleza, Brazil.'}, {'ForeName': 'Liliane Maria', 'Initials': 'LM', 'LastName': 'de Oliveira', 'Affiliation': 'School of Kinesiology, Universidade Estácio de Sá Sistema Integrado de Bibliotecas do Centro Universitário Estácio do Ceará, Fortaleza, Ceará, Brazil.'}, {'ForeName': 'Érica Carneiro Barbosa', 'Initials': 'ÉCB', 'LastName': 'Chaves', 'Affiliation': 'School of Kinesiology, Universidade Estácio de Sá Sistema Integrado de Bibliotecas do Centro Universitário Estácio do Ceará, Fortaleza, Ceará, Brazil.'}, {'ForeName': 'Vlademir Gomes', 'Initials': 'VG', 'LastName': 'Carneiro', 'Affiliation': 'School of Kinesiology, Universidade Federal da Paraíba, Joao Pessoa, Brazil.'}, {'ForeName': 'Rayane Rodrigues', 'Initials': 'RR', 'LastName': 'Monteiro', 'Affiliation': 'School of Kinesiology, Universidade Estácio de Sá Sistema Integrado de Bibliotecas do Centro Universitário Estácio do Ceará, Fortaleza, Ceará, Brazil.'}, {'ForeName': 'Thatyara Almeida de Macedo', 'Initials': 'TAM', 'LastName': 'Costa', 'Affiliation': 'School of Nutrition, Universidade Estácio de Sá Sistema Integrado de Bibliotecas do Centro Universitário Estácio do Ceará, Fortaleza, Ceará, Brazil.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Helal', 'Affiliation': 'School of Kinesiology, Universidade do Extremo Sul Catarinense, Criciuma, Brazil.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Signorile', 'Affiliation': 'Kinesiology and Sport Sciences, University of Miami, Coral Gables, Florida, USA.'}, {'ForeName': 'Lidiane Andréa Oliveira', 'Initials': 'LAO', 'LastName': 'Lima', 'Affiliation': 'Department of Physiotherapy, Universidade Federal do Ceará, Fortaleza, Brazil.'}, {'ForeName': 'Manoel Alves', 'Initials': 'MA', 'LastName': 'Sobreira-Neto', 'Affiliation': 'Division of Neurology, Universidade Federal do Ceará, Hospital Universitário Walter Cantídio, Fortaleza, Brazil.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Braga-Neto', 'Affiliation': 'Division of Neurology, Universidade Federal do Ceará, Hospital Universitário Walter Cantídio, Fortaleza, Brazil.'}]",BMJ open,['10.1136/bmjopen-2020-039941']
3325,33046478,Protocol of a randomised controlled trial on the efficacy of medication optimisation in elderly inpatients: medication optimisation protocol efficacy for geriatric inpatients (MPEG) trial.,"INTRODUCTION


Whether medication optimisation improves clinical outcomes in elderly individuals remains unclear. The current study aims to evaluate the effect of multidisciplinary team-based medication optimisation on survival, rehospitalisation and unscheduled hospital visits in elderly patients.
METHODS AND ANALYSIS


We report the protocol of a single-centre, open-label, randomised controlled trial. The enrolled subjects will be medical inpatients, aged 65 years or older, admitted to a community hospital and receiving five or more regular medications. The participants will be randomly assigned to receive either an intervention for medication optimisation or the usual care. The intervention will consist of a multidisciplinary team-based medication review, followed by a medication optimisation proposal based on the Screening Tool of Older Persons' potentially inappropriate Prescriptions/Screening Tool to Alert doctors to the Right Treatment criteria and an implicit medication optimisation protocol. Medication optimisation summaries will be sent to primary care physicians and community pharmacists on discharge. The primary outcome will be a composite of death, unscheduled hospital visits and rehospitalisation until 48 weeks after randomisation. Secondary outcomes will include each of the primary endpoints, the number of prescribed medications, quality of life score, level of long-term care required, drug-related adverse events, death during hospitalisation and falls. Participants will be followed up for 48 weeks with bimonthly telephone interviews to assess the primary and secondary outcomes. A log-rank test stratified by randomisation factors will be used to compare the incidence of the composite endpoint. The study was initiated in 2019 and a minimum of 500 patients will be enrolled.
ETHICS AND DISSEMINATION


The study protocol has been approved by the Institutional Ethical Committee of St. Marianna University School of Medicine (No. 4129). The results of the current study will be submitted to a peer-reviewed journal.
TRIAL REGISTRATION NUMBER


UMIN000035265.",2020,"The primary outcome will be a composite of death, unscheduled hospital visits and rehospitalisation until 48 weeks after randomisation.","['elderly inpatients', 'elderly patients', 'enrolled subjects will be medical inpatients, aged 65 years or older, admitted to a community hospital and receiving five or more regular medications', '500 patients will be enrolled', 'elderly individuals', 'geriatric inpatients (MPEG) trial']","['multidisciplinary team-based medication optimisation', 'intervention for medication optimisation or the usual care']","['survival, rehospitalisation and unscheduled hospital visits', 'composite of death, unscheduled hospital visits and rehospitalisation until 48 weeks after randomisation', 'number of prescribed medications, quality of life score, level of long-term care required, drug-related adverse events, death during hospitalisation and falls']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0020003', 'cui_str': 'Community hospital'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C3854240', 'cui_str': 'Unscheduled'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}]",,0.142518,"The primary outcome will be a composite of death, unscheduled hospital visits and rehospitalisation until 48 weeks after randomisation.","[{'ForeName': 'Kenya', 'Initials': 'K', 'LastName': 'Ie', 'Affiliation': 'Division of General Internal Medicine, Department of Internal Medicine, Kawasaki Municipal Tama Hospital, Kawasaki-shi, Kanagawa, Japan kenya.ie@marianna-u.ac.jp.'}, {'ForeName': 'Masanori', 'Initials': 'M', 'LastName': 'Hirose', 'Affiliation': 'Division of General Internal Medicine, Department of Internal Medicine, St Marianna University School of Medicine, Kawasaki-shi, Kanagawa, Japan.'}, {'ForeName': 'Tsubasa', 'Initials': 'T', 'LastName': 'Sakai', 'Affiliation': 'Division of General Internal Medicine, Department of Internal Medicine, Kawasaki Municipal Tama Hospital, Kawasaki-shi, Kanagawa, Japan.'}, {'ForeName': 'Iori', 'Initials': 'I', 'LastName': 'Motohashi', 'Affiliation': 'Division of General Internal Medicine, Department of Internal Medicine, Kawasaki Municipal Tama Hospital, Kawasaki-shi, Kanagawa, Japan.'}, {'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Aihara', 'Affiliation': 'Division of General Internal Medicine, Department of Internal Medicine, Kawasaki Municipal Tama Hospital, Kawasaki-shi, Kanagawa, Japan.'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Otsuki', 'Affiliation': 'Division of General Internal Medicine, Department of Internal Medicine, Kawasaki Municipal Tama Hospital, Kawasaki-shi, Kanagawa, Japan.'}, {'ForeName': 'Ayako', 'Initials': 'A', 'LastName': 'Tsuboya', 'Affiliation': 'Department of Pharmacy, Kawasaki Municipal Tama Hospital, Kawasaki-shi, Kanagawa, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Matsumoto', 'Affiliation': 'Department of Pharmacy, Kawasaki Municipal Tama Hospital, Kawasaki-shi, Kanagawa, Japan.'}, {'ForeName': 'Hikari', 'Initials': 'H', 'LastName': 'Hashi', 'Affiliation': 'Department of Pharmacy, Kawasaki Municipal Tama Hospital, Kawasaki-shi, Kanagawa, Japan.'}, {'ForeName': 'Eisuke', 'Initials': 'E', 'LastName': 'Inoue', 'Affiliation': 'Showa University Research Administration Center, Showa University, Shinagawa-ku, Tokyo, Japan.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Takahashi', 'Affiliation': 'Division of Medical Informatics, St. Marianna University School of Medicine, Kawasaki-shi, Kanagawa, Japan.'}, {'ForeName': 'Eiko', 'Initials': 'E', 'LastName': 'Komiya', 'Affiliation': 'Department of Pharmacy, Kawasaki Municipal Tama Hospital, Kawasaki-shi, Kanagawa, Japan.'}, {'ForeName': 'Yuka', 'Initials': 'Y', 'LastName': 'Itoh', 'Affiliation': 'Department of Pharmacy, Kawasaki Municipal Tama Hospital, Kawasaki-shi, Kanagawa, Japan.'}, {'ForeName': 'Tomoya', 'Initials': 'T', 'LastName': 'Tsuchida', 'Affiliation': 'Division of General Internal Medicine, Department of Internal Medicine, St Marianna University School of Medicine, Kawasaki-shi, Kanagawa, Japan.'}, {'ForeName': 'Eri', 'Initials': 'E', 'LastName': 'Kurosu', 'Affiliation': 'Division of General Internal Medicine, Department of Internal Medicine, Kawasaki Municipal Tama Hospital, Kawasaki-shi, Kanagawa, Japan.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Albert', 'Affiliation': 'Department of Behavioral and Community Health Sciences, University of Pittsburgh Graduate School of Public Health, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Chiaki', 'Initials': 'C', 'LastName': 'Okuse', 'Affiliation': 'Division of General Internal Medicine, Department of Internal Medicine, Kawasaki Municipal Tama Hospital, Kawasaki-shi, Kanagawa, Japan.'}, {'ForeName': 'Takahide', 'Initials': 'T', 'LastName': 'Matsuda', 'Affiliation': 'Division of General Internal Medicine, Department of Internal Medicine, St Marianna University School of Medicine, Kawasaki-shi, Kanagawa, Japan.'}]",BMJ open,['10.1136/bmjopen-2020-041125']
3326,33046573,PORTEC-4a: international randomized trial of molecular profile-based adjuvant treatment for women with high-intermediate risk endometrial cancer.,"BACKGROUND


Vaginal brachytherapy is currently recommended as adjuvant treatment in patients with high-intermediate risk endometrial cancer to maximize local control and has only mild side effects and no or limited impact on quality of life. However, there is still considerable overtreatment and also some undertreatment, which may be reduced by tailoring adjuvant treatment to the patients' risk of recurrence based on molecular tumor characteristics.
PRIMARY OBJECTIVES


To compare the rates of vaginal recurrence in women with high-intermediate risk endometrial cancer, treated after surgery with molecular-integrated risk profile-based recommendations for either observation, vaginal brachytherapy or external pelvic beam radiotherapy or with standard adjuvant vaginal brachytherapy STUDY HYPOTHESIS: Adjuvant treatment based on a molecular-integrated risk profile provides similar local control and recurrence-free survival as current standard adjuvant brachytherapy in patients with high-intermediate risk endometrial cancer, while sparing many patients the morbidity of adjuvant treatment and reducing healthcare costs.
TRIAL DESIGN


A multicenter, international phase III randomized trial (2:1) of molecular-integrated risk profile-based adjuvant treatment (experimental arm) or adjuvant vaginal brachytherapy (standard arm).
MAJOR INCLUSION/EXCLUSION CRITERIA


Women aged 18 years and over with a histological diagnosis of high-intermediate risk endometrioid endometrial cancer after total abdominal or laparoscopic hysterectomy and bilateral salpingo-oophorectomy. High-intermediate risk factors are defined as: (i) International Federation of Gynecology and Obstetrics stage IA (with invasion) and grade 3; (ii) stage IB grade 1 or 2 with age ≥60 and/or lymph-vascular space invasion; (iii) stage IB, grade 3 without lymph-vascular space invasion; or (iv) stage II (microscopic and grade 1).
ENDPOINTS


The primary endpoint is vaginal recurrence. Secondary endpoints are recurrence-free and overall survival; pelvic and distant recurrence; 5-year vaginal control (including treatment for relapse); adverse events and patient-reported symptoms and quality of life; and endometrial cancer-related healthcare costs.
SAMPLE SIZE


500 eligible and evaluable patients.
ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS


Estimated date for completing accrual will be late 2021. Estimated date for presentation of (first) results is expected in 2023.
TRIAL REGISTRATION


The trial is registered at clinicaltrials.gov (NCT03469674) and ISRCTN (11659025).",2020,"Adjuvant treatment based on a molecular-integrated risk profile provides similar local control and recurrence-free survival as current standard adjuvant brachytherapy in patients with high-intermediate risk endometrial cancer, while sparing many patients the morbidity of adjuvant treatment and reducing healthcare costs.
","['patients with high-intermediate risk endometrial cancer', 'women with high-intermediate risk endometrial cancer, treated after surgery with molecular-integrated risk profile-based recommendations for either observation', 'women with high-intermediate risk endometrial cancer', '500 eligible and evaluable patients', 'Women aged 18 years and over with a histological diagnosis of high-intermediate risk endometrioid endometrial cancer after total abdominal or', 'grade 3; (ii) stage IB grade 1 or 2 with age ≥60 and/or lymph-vascular space invasion; (iii) stage IB, grade 3 without lymph-vascular space invasion; or (iv) stage II (microscopic and grade 1']","['vaginal brachytherapy or external pelvic beam radiotherapy or with standard adjuvant vaginal brachytherapy', 'molecular-integrated risk profile-based adjuvant treatment (experimental arm) or adjuvant vaginal brachytherapy (standard arm', 'laparoscopic hysterectomy and bilateral salpingo-oophorectomy', 'Vaginal brachytherapy']","['rates of vaginal recurrence', 'vaginal recurrence', 'recurrence-free and overall survival; pelvic and distant recurrence; 5-year vaginal control (including treatment for relapse); adverse events and patient-reported symptoms and quality of life; and endometrial cancer-related healthcare costs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0007103', 'cui_str': 'Endometrial neoplasms malignant'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0456597', 'cui_str': 'Stage 1B'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0024202', 'cui_str': 'Lymph'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C1269955', 'cui_str': 'Tumour invasion'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0205288', 'cui_str': 'Microscopic'}]","[{'cui': 'C0854674', 'cui_str': 'Brachytherapy to vagina'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0404089', 'cui_str': 'Laparoscopic hysterectomy'}, {'cui': 'C0195495', 'cui_str': 'Bilateral salpingectomy with oophorectomy'}]","[{'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0443203', 'cui_str': 'Distant'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0007103', 'cui_str': 'Endometrial neoplasms malignant'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}]",500.0,0.16568,"Adjuvant treatment based on a molecular-integrated risk profile provides similar local control and recurrence-free survival as current standard adjuvant brachytherapy in patients with high-intermediate risk endometrial cancer, while sparing many patients the morbidity of adjuvant treatment and reducing healthcare costs.
","[{'ForeName': 'Anne Sophie V M', 'Initials': 'ASVM', 'LastName': 'van den Heerik', 'Affiliation': 'Radiation Oncology, Leiden University Medical Center, Leiden, Zuid-Holland, The Netherlands a.v.m.van_den_heerik@lumc.nl.'}, {'ForeName': 'Nanda', 'Initials': 'N', 'LastName': 'Horeweg', 'Affiliation': 'Radiation Oncology, Leiden University Medical Center, Leiden, Zuid-Holland, The Netherlands.'}, {'ForeName': 'Remi A', 'Initials': 'RA', 'LastName': 'Nout', 'Affiliation': 'Radiation Oncology, Erasmus Medical Center - Cancer Institute, Rotterdam, Zuid-Holland, The Netherlands.'}, {'ForeName': 'Ludy C H W', 'Initials': 'LCHW', 'LastName': 'Lutgens', 'Affiliation': 'Radiation Oncology, Maastricht University Medical Centre+, Maastricht, Limburg, The Netherlands.'}, {'ForeName': 'Elzbieta M', 'Initials': 'EM', 'LastName': 'van der Steen-Banasik', 'Affiliation': 'Radation Oncology, Radiotherapy Group, Arnhem, Gelderland, The Netherlands.'}, {'ForeName': 'G Henrike', 'Initials': 'GH', 'LastName': 'Westerveld', 'Affiliation': 'Radiation Oncology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, Noord-Holland, The Netherlands.'}, {'ForeName': 'Hetty A', 'Initials': 'HA', 'LastName': 'van den Berg', 'Affiliation': 'Radiation Oncology, Catharina Hospital, Eindhoven, Noord-Brabant, The Netherlands.'}, {'ForeName': 'Annerie', 'Initials': 'A', 'LastName': 'Slot', 'Affiliation': 'Radiation Oncology, Radiotherapy Institute Friesland, Leeuwarden, Friesland, The Netherlands.'}, {'ForeName': 'Friederike L A', 'Initials': 'FLA', 'LastName': 'Koppe', 'Affiliation': 'Radiation Oncology, Institute Verbeeten, Tilburg, Noord-Brabant, The Netherlands.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Kommoss', 'Affiliation': ""Women's Health, Universitätsklinikum Tübingen, Tübingen, Baden-Württemberg, Germany.""}, {'ForeName': 'Jan Willem M', 'Initials': 'JWM', 'LastName': 'Mens', 'Affiliation': 'Radiation Oncology, Erasmus Medical Center - Cancer Institute, Rotterdam, Zuid-Holland, The Netherlands.'}, {'ForeName': 'Marlies E', 'Initials': 'ME', 'LastName': 'Nowee', 'Affiliation': 'Radiation Oncology, Netherlands Cancer Institute, Amsterdam, Noord-Holland, The Netherlands.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Bijmolt', 'Affiliation': 'Radiation Oncology, University Medical Centre Groningen, University of Groningen, Groningen, Groningen, The Netherlands.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cibula', 'Affiliation': 'Gynecologic Oncology Centre, Department of Obstetrics and Gynaecology, First Faculty of Medicine, Charles University and General University Hospital, Prague, Czech Republic.'}, {'ForeName': 'Tanja C', 'Initials': 'TC', 'LastName': 'Stam', 'Affiliation': 'Radiation Oncology, Haaglanden Medical Center, Den Haag, Zuid-Holland, The Netherlands.'}, {'ForeName': 'Ina M', 'Initials': 'IM', 'LastName': 'Jurgenliemk-Schulz', 'Affiliation': 'Radiation Oncology, University Medical Centre Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'An', 'Initials': 'A', 'LastName': 'Snyers', 'Affiliation': 'Radiation Oncology, Radboudumc, Nijmegen, Gelderland, The Netherlands.'}, {'ForeName': 'Moritz', 'Initials': 'M', 'LastName': 'Hamann', 'Affiliation': ""Women's Health, Rotkreuzklinikum Munchen, Munchen, Bayern, Germany.""}, {'ForeName': 'Aleida G', 'Initials': 'AG', 'LastName': 'Zwanenburg', 'Affiliation': 'Radiation Oncology, Isala Klinieken, Zwolle, Overijssel, The Netherlands.'}, {'ForeName': 'Veronique L M A', 'Initials': 'VLMA', 'LastName': 'Coen', 'Affiliation': 'Radiation Oncology, Zuidwest Radiotherapeutic Institute, Vlissingen, Zeeland, The Netherlands.'}, {'ForeName': 'Katrien', 'Initials': 'K', 'LastName': 'Vandecasteele', 'Affiliation': 'Radiation Oncology, University Hospital Ghent, Gent, Oost-Vlaanderen, Belgium.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Gillham', 'Affiliation': ""Radiation Oncology, St. Luke's Hospital Dublin, Dublin, Ireland.""}, {'ForeName': 'Cyrus', 'Initials': 'C', 'LastName': 'Chargari', 'Affiliation': 'Radiation Oncology, Institut Gustave-Roussy, Villejuif, Île-de-France, France.'}, {'ForeName': 'Karen W', 'Initials': 'KW', 'LastName': 'Verhoeven-Adema', 'Affiliation': 'Comprehensive Cancer Centre Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Hein', 'Initials': 'H', 'LastName': 'Putter', 'Affiliation': 'Medical Statistics, Leiden University Medical Center, Leiden, Zuid-Holland, The Netherlands.'}, {'ForeName': 'Wilbert B', 'Initials': 'WB', 'LastName': 'van den Hout', 'Affiliation': 'Biomedical Data Sciences, Leiden University Medical Center, Leiden, Zuid-Holland, The Netherlands.'}, {'ForeName': 'Bastiaan G', 'Initials': 'BG', 'LastName': 'Wortman', 'Affiliation': 'Radiation Oncology, Leiden University Medical Center, Leiden, Zuid-Holland, The Netherlands.'}, {'ForeName': 'Hans W', 'Initials': 'HW', 'LastName': 'Nijman', 'Affiliation': 'Obstetrics & Gynecology, University Medical Centre Groningen, University of Groningen, Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Tjalling', 'Initials': 'T', 'LastName': 'Bosse', 'Affiliation': 'Pathology, Leiden University Medical Center, Leiden, Zuid-Holland, The Netherlands.'}, {'ForeName': 'Carien L', 'Initials': 'CL', 'LastName': 'Creutzberg', 'Affiliation': 'Radiation Oncology, Leiden University Medical Center, Leiden, Zuid-Holland, The Netherlands.'}]",International journal of gynecological cancer : official journal of the International Gynecological Cancer Society,['10.1136/ijgc-2020-001929']
3327,33062927,Impact of Patient Characteristics on Treatment Outcomes in Symptomatic Venous Thromboembolism: Results of HOKUSAI-VTE Randomized Trial Analysis.,"Introduction   In patients with venous thromboembolism (VTE), direct oral anticoagulants (DOACs) such as edoxaban, apixaban, dabigatran, and rivaroxaban are more convenient, safer, and just as effective as vitamin K antagonists (VKAs). Limited information is known about the effects of patient characteristics on VTE efficacy and safety of DOACs compared with VKAs, without appropriate effect modifier adjustment comparisons of DOACs may be biased. This study considers the effect of variables that can modify the efficacy and safety of edoxaban and warfarin, using patient-level data.  Materials and Methods   The primary efficacy and safety outcomes in the HOKUSAI-VTE study were VTE recurrence and clinically relevant bleeding, respectively. Potential effect modifiers were age, creatinine clearance, and weight. The relationship between the percentage of time in international normalized ratio (INR) control and outcomes were considered for the warfarin arm. Univariate and multivariate regression were performed for each patient characteristic.  Results   The relationship between treatment and VTE recurrence differed by age (interaction  p   = 0.007) and by creatinine clearance (  p   = 0.05). VTE recurrence differed by age for patients in the warfarin arm but not for those in the edoxaban arm and differed by INR control in the warfarin arm (  p   < 0.005). A stronger relationship between creatinine clearance and clinically relevant bleeding was found in the warfarin arm than in the edoxaban arm (  p   = 0.04). Clinically relevant bleeding differed by the percentage of time in INR control in the warfarin arm (  p   < 0.005). Age appeared to be a more important effect modifier than creatinine clearance in patients with VTE.  Discussion   The finding that efficacy in older patients was greater for those taking edoxaban than for those taking warfarin in the HOKUSAI-VTE study needs further investigation. Modification of the treatment effect by age for those taking warfarin might bias estimates of comparative effectiveness among DOACs if VKAs are the reference treatment.",2020,A stronger relationship between creatinine clearance and clinically relevant bleeding was found in the warfarin arm than in the edoxaban arm (  p   = 0.04).,"['Symptomatic Venous Thromboembolism', 'patients with venous thromboembolism (VTE), direct oral anticoagulants (DOACs) such as', 'older patients', 'patients with VTE']","['edoxaban, apixaban, dabigatran, and rivaroxaban', 'edoxaban', 'edoxaban and warfarin', 'warfarin']","['creatinine clearance and clinically relevant bleeding', 'percentage of time in international normalized ratio (INR) control and outcomes', 'creatinine clearance', 'VTE recurrence and clinically relevant bleeding', 'VTE recurrence']","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0630906', 'cui_str': 'vinyltriethoxysilane'}]","[{'cui': 'C2975435', 'cui_str': 'edoxaban'}, {'cui': 'C1831808', 'cui_str': 'apixaban'}, {'cui': 'C2348066', 'cui_str': 'dabigatran'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}]","[{'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0525032', 'cui_str': 'International normalized ratio'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0630906', 'cui_str': 'vinyltriethoxysilane'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]",,0.0706648,A stronger relationship between creatinine clearance and clinically relevant bleeding was found in the warfarin arm than in the edoxaban arm (  p   = 0.04).,"[{'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'van Hout', 'Affiliation': 'Health Economics and Decision Science Division, University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Hawe', 'Affiliation': 'Data Analytics and Design Strategy Division, RTI-Health Solutions, Manchester, United Kingdom.'}, {'ForeName': 'Alexander T', 'Initials': 'AT', 'LastName': 'Cohen', 'Affiliation': ""Department of Haematology, Guy's and St Thomas' NHS Foundation Trust, London, United Kingdom.""}]",TH open : companion journal to thrombosis and haemostasis,['10.1055/s-0040-1716496']
3328,33063249,Effect of Sacubitril/Valsartan on Neurocognitive Function: Current Status and Future Directions.,"Sacubitril/valsartan is a new medication approved for the treatment of heart failure with reduced ejection fraction. While the drug failed to meet the primary endpoint in patients with heart failure with preserved ejection fraction in the PARAGON-HF trial, improvements were noted in several secondary endpoints. Valsartan is an angiotensin receptor blocker and sacubitril is a neprilysin inhibitor. Neprilysin is postulated to have a role in the degradation of beta-amyloid in the brain; therefore, sacubitril could theoretically increase beta-amyloid plaque deposition in the brain and potentially increase the risk of Alzheimer's disease. Although pre-clinical and clinical studies have shown promising safety results, those studies have been heavily criticized for short monitoring time and targeted populations. In accordance with the requirements of the US Food and drug Administration (FDA), the ongoing Prospective Evaluation of Cognitive Function in Heart Failure: Efficacy and Safety of Entresto compared to Valsartan on Cognitive Function in Patients with Chronic Heart Failure and Preserved Ejection Fraction (PERSPECTIVE; NCT02884206) multicenter, randomized, double-blinded trial is assessing the long-term neurocognitive effects and safety of sacubitril/valsartan, and results are expected in early 2022.",2020,"While the drug failed to meet the primary endpoint in patients with heart failure with preserved ejection fraction in the PARAGON-HF trial, improvements were noted in several secondary endpoints.",['Patients with Chronic Heart Failure and Preserved Ejection Fraction'],"['Valsartan', 'Sacubitril/valsartan', 'Sacubitril/Valsartan', 'sacubitril/valsartan']","['Neurocognitive Function', 'Cognitive Function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}]","[{'cui': 'C0216784', 'cui_str': 'valsartan'}, {'cui': 'C4033631', 'cui_str': 'valsartan and sacubitril'}]","[{'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",,0.0439181,"While the drug failed to meet the primary endpoint in patients with heart failure with preserved ejection fraction in the PARAGON-HF trial, improvements were noted in several secondary endpoints.","[{'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Galo', 'Affiliation': 'Division of Internal Medicine, Department of Medicine, University of Miami/Jackson Memorial Hospital, 1611 NW 12th Ave, Central Building 600D, Miami, FL, 33136, USA. jason.galo@jhsmiami.org.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Celli', 'Affiliation': 'Division of Internal Medicine, Department of Medicine, University of Miami/Jackson Memorial Hospital, 1611 NW 12th Ave, Central Building 600D, Miami, FL, 33136, USA.'}, {'ForeName': 'Rosario', 'Initials': 'R', 'LastName': 'Colombo', 'Affiliation': 'Division of Cardiovascular Disease, Jackson Memorial Hospital, 1801 NW 9th Ave, Suite #209, Miami, FL, 33136, USA.'}]","American journal of cardiovascular drugs : drugs, devices, and other interventions",['10.1007/s40256-020-00445-7']
3329,33063953,Acute beetroot juice supplementation improves exercise tolerance and cycling efficiency in adults with obesity.,"BACKGROUND


Exercise training improves health outcomes in individuals with obesity (IO); however, it remains challenging for IO to adhere to exercise. Thus, it is critical to identify novel strategies that improve exercise tolerance (ET) and adherence in IO. Beetroot juice (BRJ), high in inorganic dietary nitrate, consistently improves exercise performance in athletes, individuals with cardiopulmonary diseases, and nonobese lean individuals. These improvements may be explained by reduced oxygen uptake (VO 2  ) during exercise, enhanced blood flow, and greater mitochondrial efficiency. To date, we are aware of no studies that have compared the effects of BRJ, sodium nitrate (NaNO3), and nitrate-depleted BRJ (PLA) for improving ET and cardiometabolic health in IO.
PURPOSE


Determine if BRJ improves ET, exercise efficiency (EE), and cardiometabolic health in IO and identify possible mechanisms of action.
METHODS


Vascular hemodynamic, submaximal- and maximal-exercise VO 2  , and time to exhaustion (TTE) were assessed in 16 participants 2.5 hr following consumption of: 1) BRJ, 2) NaNO 3  , 3) PLA, or 4) CON.
RESULTS


A significant treatment effect was observed for submaximal exercise VO 2  (p = .003), and TTE (p < .001). Post hoc analyses revealed lower VO 2  during submaximal exercise in BRJ compared to PLA (p = .009) NaNO3 (p = .042) and CON (0.009), equating to an average improvement of ~ 7% with BRJ. TTE was greater for BRJ compared to other treatment arms, PLA (p = .008), NaNO3 (p = .038), and CON (p=<0.001), equating to ~ 15% improvement with BRJ. No significant changes were observed for other outcomes.
CONCLUSIONS


Consumption of BRJ improved EE during submaximal exercise by 7%, and TTE by 15% compared to other conditions. These results suggest that BRJ may improve EE and exercise tolerance in IO.",2020,"A significant treatment effect was observed for submaximal exercise VO 2  (p = .003), and TTE (p < .001).","['adults with obesity', 'athletes, individuals with cardiopulmonary diseases, and nonobese lean individuals', '16 participants 2.5\xa0hr following consumption of: 1) BRJ, 2) NaNO 3  , 3) PLA, or 4) CON', 'individuals with obesity (IO']","['Exercise training', 'Beetroot juice (BRJ), high in inorganic dietary nitrate', 'BRJ, sodium nitrate (NaNO3), and nitrate-depleted BRJ (PLA', 'Acute beetroot juice supplementation', 'BRJ']","['exercise tolerance and cycling efficiency', 'exercise tolerance (ET) and adherence', 'Vascular hemodynamic, submaximal- and maximal-exercise VO 2  , and time to exhaustion (TTE', 'oxygen uptake (VO 2  ) during exercise, enhanced blood flow, and greater mitochondrial efficiency', 'health outcomes', 'EE and exercise tolerance', 'NaNO3', 'ET, exercise efficiency (EE), and cardiometabolic health', 'submaximal exercise VO 2', 'exercise performance']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0034072', 'cui_str': 'Cor pulmonale'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1095905', 'cui_str': 'Beets preparation'}, {'cui': 'C0456170', 'cui_str': 'Left atrial pressure'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C1095905', 'cui_str': 'Beets preparation'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0074748', 'cui_str': 'sodium nitrate'}, {'cui': 'C0456170', 'cui_str': 'Left atrial pressure'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0162521', 'cui_str': 'Exercise tolerance'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0430462', 'cui_str': 'Transthoracic echocardiography'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0587107', 'cui_str': 'During exercise'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0026237', 'cui_str': 'Mitochondrion'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",16.0,0.0309602,"A significant treatment effect was observed for submaximal exercise VO 2  (p = .003), and TTE (p < .001).","[{'ForeName': 'Christian E', 'Initials': 'CE', 'LastName': 'Behrens', 'Affiliation': 'Department of Nutrition Sciences, The University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Khandaker', 'Initials': 'K', 'LastName': 'Ahmed', 'Affiliation': 'Department of Pathology and Center for Free Radical Biology, The University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Karina', 'Initials': 'K', 'LastName': 'Ricart', 'Affiliation': 'Department of Pathology and Center for Free Radical Biology, The University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Braxton', 'Initials': 'B', 'LastName': 'Linder', 'Affiliation': 'Department of Human Studies, The University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Fernández', 'Affiliation': 'Department of Nutrition Sciences, The University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Bertrand', 'Affiliation': 'Department of Nutrition Sciences, The University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Rakesh P', 'Initials': 'RP', 'LastName': 'Patel', 'Affiliation': 'Department of Pathology and Center for Free Radical Biology, The University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Fisher', 'Affiliation': 'Department of Human Studies, The University of Alabama at Birmingham, Birmingham, AL, USA.'}]",Physiological reports,['10.14814/phy2.14574']
3330,33063959,[Transcanalicular balloon dacryoplasty for the treatment of post-dacryocystorhinostomy recurrent stenoses].,"PURPOSE


To compare the effectiveness of minimally invasive techniques used for the treatment of common canalicular (CC) ostium stenosis (or obliteration) in post-dacryocystorhinostomy (post-DCR) patients.
MATERIAL AND METHODS


The study included 121 patients (127 cases), of which 61 patients (64 cases) had stenosis of the CC ostium and 60 patients (63 cases) had CC ostium obliteration. All stenoses and obliterations were recurrent and developed 6 months to 5 years after primary endonasal endoscopic DCR. Patients were divided into 3 groups. Group 1 included 20 patients (20 cases) with stenosis and 21 patients (22 cases) with CC ostium obliteration who underwent transcanalicular balloon dacryoplasty (DCP), group 2 - 20 patients (21 cases) with stenosis and 20 patients (21 cases) with CC ostium obliteration who underwent transcanalicular DCP and bicanalicular intubation, and group 3 - 21 patients (23 cases) with stenosis and 19 patients (20 cases) with CC ostium obliteration who received bicanalicular intubation alone. Results were evaluated 12 months after the intervention.
RESULTS


The treatment was effective in as many as 80% and 68.2% of cases (respectively) in group 1, 76.2% and 66.7% of cases (respectively) in group 2, and 56.5% and 50% of cases (respectively) in group 3.
CONCLUSION


The study proves transcanalicular DCP effective alone and shows no need in potentially complicated lacrimal ducts intubation.",2020,All stenoses and obliterations were recurrent and developed 6 months to 5 years after primary endonasal endoscopic DCR.,"[' and group 3 - 21 patients (23 cases) with stenosis and 19 patients (20 cases) with', 'common canalicular (CC) ostium stenosis (or obliteration) in post-dacryocystorhinostomy (post-DCR) patients', '121 patients (127 cases), of which 61 patients (64 cases) had stenosis of the CC ostium and 60 patients (63 cases) had CC ostium obliteration', '20 patients (20 cases) with stenosis and 21 patients (22 cases) with', 'post-dacryocystorhinostomy recurrent stenoses', ' group 2 - 20 patients (21 cases) with stenosis and 20 patients (21 cases) with']","['CC ostium obliteration who received bicanalicular intubation alone', 'CC ostium obliteration who underwent transcanalicular balloon dacryoplasty (DCP', 'CC ostium obliteration who underwent transcanalicular DCP and bicanalicular intubation']",[],"[{'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0444567', 'cui_str': 'Ostium'}, {'cui': 'C0332465', 'cui_str': 'Obliteration'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0010931', 'cui_str': 'Dacryocystorhinostomy'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}]","[{'cui': 'C0444567', 'cui_str': 'Ostium'}, {'cui': 'C0332465', 'cui_str': 'Obliteration'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C1531513', 'cui_str': 'Balloon dacryoplasty'}, {'cui': 'C3160746', 'cui_str': 'Dacryoplasty'}]",[],121.0,0.0123305,All stenoses and obliterations were recurrent and developed 6 months to 5 years after primary endonasal endoscopic DCR.,"[{'ForeName': 'E L', 'Initials': 'EL', 'LastName': ""At'kova"", 'Affiliation': 'Research Institute of Eye Diseases, Moscow, Russia.'}, {'ForeName': 'N N', 'Initials': 'NN', 'LastName': 'Krakhovetskiy', 'Affiliation': 'Research Institute of Eye Diseases, Moscow, Russia.'}, {'ForeName': 'O V', 'Initials': 'OV', 'LastName': 'Zhukov', 'Affiliation': 'Research Institute of Eye Diseases, Moscow, Russia.'}]",Vestnik oftalmologii,['10.17116/oftalma2020136052163']
3331,33064404,Effects of Cognitive Training and Exergaming in Pediatric Cancer Survivors-A Randomized Clinical Trial.,"PURPOSE


Although most pediatric cancer patients survive, those who undergo anticancer treatments like chemotherapy and/or radiotherapy are at a high risk for late effects, such as cognitive deficits. To counteract these deficits, feasible and effective interventions are needed. The aim of this study was to compare the effects of working memory training, exergaming, and a wait-list control condition on cognitive functions in pediatric cancer survivors.
METHODS


In a parallel-group randomized trial, 69 pediatric cancer survivors aged 7-16 yr (mean = 11.35, SD = 3.53) were randomly assigned to 8-wk working memory training, exergaming, or a wait-list control group. Each training course consisted of three 45-min training sessions per week. The primary outcome comprised the core executive functions (visual working memory, inhibition, switching), and the secondary outcomes included other cognitive domains (intelligence, planning, memory, attention, processing speed), motor abilities, and parent rating on their children's executive functions. Assessments were conducted both before and immediately after the interventions, and at 3-month follow-up.
RESULTS


Linear mixed models revealed that participants in the working memory training group showed a linear improvement in visual working memory after training and at follow-up compared with the control group. No other intervention effects of either type of training could be detected.
CONCLUSION


This study presents evidence that working memory training improves visual working memory in pediatric cancer survivors. Results show that near-transfer, but no far-transfer effects can be expected from working memory training. Multiple-component interventions tailored to fit the individual's cognitive profile are needed to best support cognitive development after cancer and its treatment.",2020,"RESULTS


Linear mixed models revealed that participants in the working memory training group showed a linear improvement in visual working memory after training and at follow-up compared with the control group.","['Pediatric Cancer Survivors', 'pediatric cancer survivors', 'pediatric cancer patients survive, those who undergo anticancer treatments like', '69 pediatric cancer survivors aged 7-16 yr (mean = 11.35, SD = 3.53']","['Cognitive Training and Exergaming', '8-wk working memory training, exergaming, or a wait-list control group', 'working memory training, exergaming, and a wait-list control condition', 'working memory training', 'chemotherapy and/or radiotherapy']","['visual working memory', ""core executive functions (visual working memory, inhibition, switching), and the secondary outcomes included other cognitive domains (intelligence, planning, memory, attention, processing speed), motor abilities, and parent rating on their children's executive functions""]","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]","[{'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0021704', 'cui_str': 'Intelligence'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0582591', 'cui_str': 'Processing speed'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0030551', 'cui_str': 'Parent'}]",69.0,0.0718329,"RESULTS


Linear mixed models revealed that participants in the working memory training group showed a linear improvement in visual working memory after training and at follow-up compared with the control group.","[{'ForeName': 'Valentin', 'Initials': 'V', 'LastName': 'Benzing', 'Affiliation': ""1Institute of Sport Science, University of Bern, Bern, SWITZERLAND 2Division of Pediatric Hematology and Oncology, University Children's Hospital Bern, Inselspital, Bern University Hospital, University of Bern, Bern, SWITZERLAND 3Division of Neuropaediatrics, Development and Rehabilitation, University Children's Hospital Bern, Inselspital, Bern University Hospital, University of Bern, Bern, SWITZERLAND 4Institute of Psychology, University of Bern, Bern, SWITZERLAND 5Division of Pediatric Oncology, University Children's Hospital Zurich, Zurich, SWITZERLAND.""}, {'ForeName': 'Janine', 'Initials': 'J', 'LastName': 'SpitzhÜttl', 'Affiliation': ''}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Siegwart', 'Affiliation': ''}, {'ForeName': 'JÜrg', 'Initials': 'J', 'LastName': 'Schmid', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Grotzer', 'Affiliation': ''}, {'ForeName': 'Theda', 'Initials': 'T', 'LastName': 'Heinks', 'Affiliation': ''}, {'ForeName': 'Claudia M', 'Initials': 'CM', 'LastName': 'Roebers', 'Affiliation': ''}, {'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'Steinlin', 'Affiliation': ''}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Leibundgut', 'Affiliation': ''}, {'ForeName': 'Mirko', 'Initials': 'M', 'LastName': 'Schmidt', 'Affiliation': ''}, {'ForeName': 'Regula', 'Initials': 'R', 'LastName': 'Everts', 'Affiliation': ''}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002386']
3332,33064410,"Is There a Link between Stress and Cognition, and Capacity to Execute Motor Skill?","PURPOSE


This study aimed to examine the link between stress (measured via salivary cortisol and testosterone), cognition (measured via pupillometry, with greater pupil constriction and reduced pupil constriction latency associated with increased attention and improved information processing), and motor skill capacity (measured via somatosensory processing).
METHODS


Twenty-five professional rugby players participated in this study. Saliva samples were collected upon waking, before pupillometry and somatosensory processing testing, and after testing. Testing times varied for participants; however, it was always in the morning, and the order of testing was randomized.
RESULTS


Very small differences in hormone concentrations were seen across the morning (effect size = 0.01). Moderate to large differences in left eye pupil constriction for direct (left eye) versus consensual (right eye) stimulus were also seen (P < 0.01; effect size = 0.51 to 1.04). No differences for pupil constriction latency were seen for direct versus consensual stimulus. Some positive weak to moderate relationships were seen for testosterone and pupil constriction latency (r = 0.37 to 0.39, P < 0.05). Moderate to strong inverse relationships were seen for hormones with left eye pupil constriction difference between direct and consensual stimulus, and for pre- to posttest testosterone-to-cortisol ratio decline with left eye pupil constriction for direct and consensual stimulus (r = 0.41 to 0.52, P < 0.05). Weak to moderate inverse relationships for testosterone-to-cortisol ratio decline and somatosensory processing were seen (r = 0.36 to 0.47, P < 0.05).
CONCLUSION


Stress may affect ability to receive information and ability to execute motor tasks. Thus, stress may compromise ability to make appropriate objective decisions and consequently execute skill/task behavior. Strategies to help mitigate negative stress responses are noted.",2020,"Moderate to strong inverse relationships were seen for hormones with left eye pupil constriction difference between direct and consensual stimulus, and for pre- to posttest testosterone-to-cortisol ratio decline with left eye pupil constriction for direct and consensual stimulus (r = 0.41 to 0.52, P < 0.05).",['Twenty-five professional rugby players participated in this study'],[],"['pupil constriction latency', 'hormone concentrations', 'testosterone-to-cortisol ratio decline and somatosensory processing', 'stress (measured via salivary cortisol and testosterone), cognition (measured via pupillometry, with greater pupil constriction and reduced pupil constriction latency associated with increased attention and improved information processing), and motor skill capacity (measured via somatosensory processing', 'testosterone and pupil constriction latency']","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0035945', 'cui_str': 'Rugby'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0026205', 'cui_str': 'Persistent miosis'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0021420', 'cui_str': 'Information Processing'}, {'cui': 'C0026612', 'cui_str': 'Motor Skills'}]",25.0,0.0355224,"Moderate to strong inverse relationships were seen for hormones with left eye pupil constriction difference between direct and consensual stimulus, and for pre- to posttest testosterone-to-cortisol ratio decline with left eye pupil constriction for direct and consensual stimulus (r = 0.41 to 0.52, P < 0.05).","[{'ForeName': 'Benjamin G', 'Initials': 'BG', 'LastName': 'Serpell', 'Affiliation': '1University of Canberra Research Institute for Sport and Exercise (UCRISE), University of Canberra, Bruce, AUSTRALIA 2Brumbies Rugby, Bruce, AUSTRALIA 3Performance People and Teams, Australian Institute of Sport, Bruce, AUSTRALIA 4Sports Medicine, Australian Institute of Sport, Bruce, AUSTRALIA 5Human Factors and Behavioral Neurobiology Department, Embry-Riddle Aeronautical University, Daytona Beach, FL 6Human Performance, Sport and Physiology Group, Brain-Behaviour Research Group, Biomedical Discipline School of Science and Technology, University of New England, Armidale, AUSTRALIA.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Waddington', 'Affiliation': ''}, {'ForeName': 'Braden', 'Initials': 'B', 'LastName': 'McGrath', 'Affiliation': ''}, {'ForeName': 'Christian J', 'Initials': 'CJ', 'LastName': 'Cook', 'Affiliation': ''}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002397']
3333,33064412,Exercise Training Improves Microvascular Function in Burn Injury Survivors.,"INTRODUCTION


Vasodilator function is impaired in individuals with well-healed burn injuries; however, therapeutic interventions that lessen or reverse this maladaptation are lacking. The purpose of this study was to test the hypothesis that a 6-month community-based exercise training program would increase microvascular dilator function in individuals with well-healed burn injuries, irrespective of the magnitude of the injured body surface area. Further, we hypothesize that macrovascular dilator function would remain unchanged posttraining.
METHODS


Microvascular function (forearm reactive hyperemia), macrovascular function (brachial artery flow-mediated dilation), and the maximal vasodilatory response after ischemic handgrip exercise (an estimate of microvascular remodeling) were assessed before and after exercise training in nonburned control subjects (n = 11) and individuals with burn injuries covering a moderate body surface area (26% ± 7%; n = 13) and a high body surface area (59% ± 15%; n = 19).
RESULTS


Peak vascular conductance and area under the curve during postocclusive reactive hyperemia increased from pretraining to posttraining in control and burn injury groups (both P < 0.05), the magnitude of which did not differ between groups (both P = 0.6). Likewise, the maximal vasodilatory response after ischemic handgrip exercise increased in all groups after exercise training (P < 0.05). Macrovascular dilator function did not differ across time or between groups (P = 0.8).
CONCLUSIONS


These data suggest that a community-based exercise training program improves microvascular function in individuals with well-healed burn injuries, which may be due in part to vascular remodeling.",2020,"Macrovascular dilator function did not differ across time or between groups (P = 0.8).
","['individuals with well-healed burn injuries', 'Burn Injury Survivors', 'nonburned control subjects (n = 11) and individuals with burn injuries covering a moderate body surface area (26% ± 7%; n = 13) and a high body surface area (59% ± 15%; n = 19']","['ischemic handgrip exercise', 'community-based exercise training program', 'exercise training', 'Exercise Training']","['macrovascular dilator function', 'Microvascular Function', 'maximal vasodilatory response after ischemic handgrip exercise', 'microvascular dilator function', 'Macrovascular dilator function', 'Peak vascular conductance and area under the curve during postocclusive reactive hyperemia', 'Microvascular function (forearm reactive hyperemia), macrovascular function (brachial artery flow-mediated dilation', 'microvascular function']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0006434', 'cui_str': 'Burn injury'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0005902', 'cui_str': 'Body surface area'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0180431', 'cui_str': 'Dilator'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0178824', 'cui_str': 'Reactive Hyperemia'}, {'cui': 'C0016536', 'cui_str': 'Forearm structure'}, {'cui': 'C0006087', 'cui_str': 'Structure of brachial artery'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}]",,0.019027,"Macrovascular dilator function did not differ across time or between groups (P = 0.8).
","[{'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Romero', 'Affiliation': '1University of Texas Southwestern Medical Center and Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas, Dallas, TX 2University of North Texas Health Science Center, Ft. Worth, TX.'}, {'ForeName': 'Gilbert', 'Initials': 'G', 'LastName': 'Moralez', 'Affiliation': ''}, {'ForeName': 'Manall F', 'Initials': 'MF', 'LastName': 'Jaffery', 'Affiliation': ''}, {'ForeName': 'M U', 'Initials': 'MU', 'LastName': 'Huang', 'Affiliation': ''}, {'ForeName': 'Rachel E', 'Initials': 'RE', 'LastName': 'Engelland', 'Affiliation': ''}, {'ForeName': 'Matthew N', 'Initials': 'MN', 'LastName': 'Cramer', 'Affiliation': ''}, {'ForeName': 'Craig G', 'Initials': 'CG', 'LastName': 'Crandall', 'Affiliation': ''}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002379']
3334,33064413,Synergetic Effect of NO Precursor Supplementation and Exercise Training.,"INTRODUCTION


Nitric oxide (NO) precursor supplementation has been shown to increase NO bioavailability and can potentially improve vascular function and exercise performance. It remains unclear whether the combination of NO precursor supplementation and exercise training has synergic effects on exercise performance. This study aims to assess the effect of chronic nitrate and citrulline intake on exercise training adaptations in healthy young individuals.
METHODS


In this randomized, double-bind trial, 24 healthy young (12 females) subjects performed vascular function assessment (blood pressure, pulse wave velocity, postischemia vasodilation, and cerebrovascular reactivity) and both local (submaximal isometric unilateral knee extension) and whole-body (incremental cycling) exercise tests to exhaustion before and after a 2-month exercise training program and daily intake of a placebo or a nitrate-rich salad and citrulline (N + C, 520 mg nitrate and 6 g citrulline) drink. Prefrontal cortex and quadriceps oxygenation was monitored continuously during exercise by near-infrared spectroscopy.
RESULTS


N + C supplementation had no effect on vascular function and muscle and cerebral oxygenation during both local and whole-body exercise. N + C supplementation induced a significantly larger increase in maximal knee extensor strength (+5.1 ± 3.5 vs +0.2 ± 5.5 kg, P = 0.008) as well as a trend toward a larger increase in knee extensor endurance (+35.2 ± 26.1 vs +24.0 ± 10.4 contractions, P = 0.092) than placebo, but no effect on exercise training-induced maximal aerobic performance improvement.
CONCLUSION


These results suggest that chronic nitrate and citrulline supplementation enhances the effect of exercise training on quadriceps muscle function in healthy active young individuals, but this does not translate into improved maximal aerobic performances.",2020,"N + C supplementation induced a significantly larger increase in maximal knee extensor strength (+5.1 ± 3.5 vs +0.2 ± 5.5 kg, P = 0.008) as well as a trend toward a larger increase in knee extensor endurance (+35.2 ± 26.1 vs +24.0 ± 10.4 contractions, P = 0.092) than placebo, but no effect on exercise training-induced maximal aerobic performance improvement.
","['healthy young individuals', '24 healthy young (12 females) subjects performed', 'healthy active young individuals']","['N + C supplementation', 'exercise training', 'placebo', 'Nitric oxide ', 'chronic nitrate and citrulline intake', 'NO Precursor Supplementation and Exercise Training', 'local (submaximal isometric unilateral knee extension) and whole-body (incremental cycling) exercise tests to exhaustion before and after a 2-month exercise training program and daily intake of a placebo or a nitrate-rich salad and citrulline (N + C, 520 mg nitrate and 6 g citrulline) drink']","['Prefrontal cortex and quadriceps oxygenation', 'vascular function assessment (blood pressure, pulse wave velocity, postischemia vasodilation, and cerebrovascular reactivity', 'vascular function and muscle and cerebral oxygenation', 'maximal aerobic performances', 'maximal aerobic performance improvement', 'vascular function and exercise performance', 'knee extensor endurance', 'maximal knee extensor strength', 'quadriceps muscle function']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0008864', 'cui_str': 'Citrulline'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0453740', 'cui_str': 'Salad'}, {'cui': 'C4517803', 'cui_str': '520'}, {'cui': 'C1722869', 'cui_str': '(glycyl-prolyl-glycyl-glycyl-alanyl)6-glycine'}, {'cui': 'C0452428', 'cui_str': 'Drink'}]","[{'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0042401', 'cui_str': 'Vasodilatation'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0231484', 'cui_str': 'Muscle function'}]",24.0,0.0624846,"N + C supplementation induced a significantly larger increase in maximal knee extensor strength (+5.1 ± 3.5 vs +0.2 ± 5.5 kg, P = 0.008) as well as a trend toward a larger increase in knee extensor endurance (+35.2 ± 26.1 vs +24.0 ± 10.4 contractions, P = 0.092) than placebo, but no effect on exercise training-induced maximal aerobic performance improvement.
","[{'ForeName': 'Thibault', 'Initials': 'T', 'LastName': 'LE Roux-Mallouf', 'Affiliation': '1HP2 Laboratory INSERM U1042, Faculty of Medicine, Université Grenoble Alpes, Grenoble, FRANCE 2Sport and Pathologies Unit, Grenoble Alpes University Hospital, Hôpital Michallon, Grenoble, FRANCE.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Vallejo', 'Affiliation': ''}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Pelen', 'Affiliation': ''}, {'ForeName': 'Idir', 'Initials': 'I', 'LastName': 'Halimaoui', 'Affiliation': ''}, {'ForeName': 'StÉphane', 'Initials': 'S', 'LastName': 'Doutreleau', 'Affiliation': ''}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Verges', 'Affiliation': ''}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002387']
3335,33055113,Intermittent antegrade warm-blood versus cold-blood cardioplegia in children undergoing open heart surgery: a protocol for a randomised controlled study (Thermic-3).,"INTRODUCTION


Surgical repair of congenital heart defects often requires the use of cardiopulmonary bypass (CPB) and cardioplegic arrest. Cardioplegia is used during cardiac surgery requiring CPB to keep the heart still and to reduce myocardial damage as a result of ischaemia-reperfusion injury. Cold cardioplegia is the prevalent method of myocardial protection in paediatric patients; however, warm cardioplegia is used as part of usual care throughout the UK in adults. We aim to provide evidence to support the use of warm versus cold blood cardioplegia on clinical and biochemical outcomes during and after paediatric congenital heart surgery.
METHODS AND ANALYSIS


We are conducting a single-centre randomised controlled trial in paediatric patients undergoing operations requiring CPB and cardioplegic arrest at the Bristol Royal Hospital for Children. We will randomise participants in a 1:1 ratio to receive either 'cold-blood cardioplegia' or 'warm-blood cardioplegia'. The primary outcome will be the difference between groups with respect to Troponin T levels over the first 48 postoperative hours. Secondary outcomes will include measures of cardiac function; renal function; cerebral function; arrythmias during and postoperative hours; postoperative blood loss in the first 12 hours; vasoactive-inotrope score in the first 48 hours; intubation time; chest and wound infections; time from return from theatre until fit for discharge; length of postoperative hospital stay; all-cause mortality to 3 months postoperative; myocardial injury at the molecular and cellular level.
ETHICS AND DISSEMINATION


This trial has been approved by the London - Central Research Ethics Committee. Findings will be disseminated to the academic community through peer-reviewed publications and presentation at national and international meetings. Patients will be informed of the results through patient organisations and newsletters to participants.
TRIAL REGISTRATION NUMBER


ISRCTN13467772; Pre-results.",2020,We are conducting a single-centre randomised controlled trial in paediatric patients undergoing operations requiring CPB and cardioplegic arrest at the Bristol Royal Hospital for Children.,"['paediatric patients undergoing operations requiring CPB and cardioplegic arrest at the Bristol Royal Hospital for Children', 'paediatric patients', 'children undergoing open heart surgery']","['warm versus cold blood cardioplegia', 'Intermittent antegrade warm-blood versus cold-blood cardioplegia', 'Cold cardioplegia', ""cold-blood cardioplegia' or 'warm-blood cardioplegia"", 'Cardioplegia', 'cardiopulmonary bypass (CPB']","['Troponin T levels', 'measures of cardiac function; renal function; cerebral function; arrythmias during and postoperative hours; postoperative blood loss in the first 12\u2009hours; vasoactive-inotrope score in the first 48\u2009hours; intubation time; chest and wound infections; time from return from theatre until fit for discharge; length of postoperative hospital stay; all-cause mortality to 3 months postoperative; myocardial injury at the molecular and cellular level']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0189745', 'cui_str': 'Open heart surgery'}]","[{'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0018791', 'cui_str': 'Induced cardioplegia'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0589502', 'cui_str': 'Antegrade direction'}, {'cui': 'C0522789', 'cui_str': 'Cryocardioplegia'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}]","[{'cui': 'C0077404', 'cui_str': 'Troponin T'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0234386', 'cui_str': 'Cerebral function'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0032788', 'cui_str': 'Postoperative hemorrhage'}, {'cui': 'C1292430', 'cui_str': '12 hours'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0043241', 'cui_str': 'Local infection of wound'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0475307', 'cui_str': 'Theatre'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0007634', 'cui_str': 'Cell structure'}]",,0.18115,We are conducting a single-centre randomised controlled trial in paediatric patients undergoing operations requiring CPB and cardioplegic arrest at the Bristol Royal Hospital for Children.,"[{'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Heys', 'Affiliation': 'Bristol Trials Centre, Clincal Trials and Evaulation Unit, Bristol Medical School, University of Bristol, Bristol, UK rh13369@bristol.ac.uk.'}, {'ForeName': 'Serban', 'Initials': 'S', 'LastName': 'Stoica', 'Affiliation': 'Bristol Royal Hospital for Children, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Gianni', 'Initials': 'G', 'LastName': 'Angelini', 'Affiliation': 'National Institute for Health Research Bristol Biomedical Research Centre, University Hospitals Bristol NHS Foundation Trust and University of Bristol, Bristol, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Beringer', 'Affiliation': 'Bristol Royal Hospital for Children, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Evans', 'Affiliation': 'Bristol Trials Centre, Clincal Trials and Evaulation Unit, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Ghorbel', 'Affiliation': 'Bristol Heart Institue, University of Bristol, Bristol, UK.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Lansdowne', 'Affiliation': 'Bristol Royal Hospital for Children, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Parry', 'Affiliation': 'Bristol Royal Hospital for Children, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Pieles', 'Affiliation': 'Bristol Royal Hospital for Children, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Barnaby', 'Initials': 'B', 'LastName': 'Reeves', 'Affiliation': 'Bristol Trials Centre, Clincal Trials and Evaulation Unit, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Rogers', 'Affiliation': 'Bristol Trials Centre, Clincal Trials and Evaulation Unit, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Saxena', 'Affiliation': 'Cardiac Intensive Care, Great Ormond Street Hospital For Children NHS Foundation Trust, London, UK.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Sheehan', 'Affiliation': 'National Institute for Health Research Bristol Biomedical Research Centre, University Hospitals Bristol NHS Foundation Trust and University of Bristol, Bristol, UK.'}, {'ForeName': 'Stella', 'Initials': 'S', 'LastName': 'Smith', 'Affiliation': 'Bristol Royal Hospital for Children, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Terrie', 'Initials': 'T', 'LastName': 'Walker-Smith', 'Affiliation': 'Bristol Trials Centre, Clincal Trials and Evaulation Unit, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Robert Mr', 'Initials': 'RM', 'LastName': 'Tulloh', 'Affiliation': 'National Institute for Health Research Bristol Biomedical Research Centre, University Hospitals Bristol NHS Foundation Trust and University of Bristol, Bristol, UK.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Caputo', 'Affiliation': 'Bristol Royal Hospital for Children, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}]",BMJ open,['10.1136/bmjopen-2020-036974']
3336,33055122,Trial of remote ischaemic preconditioning in vascular cognitive impairment (TRIC-VCI): protocol.,"INTRODUCTION


Cerebral small vessel disease (cSVD) accounts for 20%-25% of strokes and is the most common cause of vascular cognitive impairment (VCI). In an animal VCI model, inducing brief periods of limb ischaemia-reperfusion reduces subsequent ischaemic brain injury with remote and local protective effects, with hindlimb remote ischaemic conditioning (RIC) improving cerebral blood flow, decreasing white-matter injury and improving cognition. Small human trials suggest RIC is safe and may prevent recurrent strokes. It remains unclear what doses of chronic daily RIC are tolerable and safe, whether effects persist after treatment cessation, and what parameters are optimal for treatment response.
METHODS AND ANALYSIS


This prospective, open-label, randomised controlled trial (RCT) with blinded end point assessment and run-in period, will recruit 24 participants, randomised to one of two RIC intensity groups: one arm treated once daily or one arm twice daily for 30 consecutive days. RIC will consistent of 4 cycles of blood pressure cuff inflation to 200 mm Hg for 5 min followed by 5 min deflation (total 35 min). Selection criteria include: age 60-85 years, evidence of cSVD on brain CT/MRI, Montreal Cognitive Assessment (MoCA) score 13-24 and preserved basic activities of living. Outcomes will be assessed at 30 days and 90 days (60 days after ceasing treatment). The primary outcome is adherence (completing ≥80% of sessions). Secondary safety/tolerability outcomes include the per cent of sessions completed and pain/discomfort scores from patient diaries. Efficacy outcomes include changes in cerebral blood flow (per arterial spin-label MRI), white-matter hyperintensity volume, diffusion tensor imaging, MoCA and Trail-Making tests.
ETHICS AND DISSEMINATION


Research Ethics Board approval has been obtained. The results will provide information on feasibility, dose, adherence, tolerability and outcome measures that will help design a phase IIb RCT of RIC, with the potential to prevent VCI. Results will be disseminated through peer-reviewed publications, organisations and meetings.
TRIAL REGISTRATION NUMBER


NCT04109963.",2020,"Efficacy outcomes include changes in cerebral blood flow (per arterial spin-label MRI), white-matter hyperintensity volume, diffusion tensor imaging, MoCA and Trail-Making tests.
","['24 participants', 'vascular cognitive impairment (TRIC-VCI', 'Selection criteria include: age 60-85 years, evidence of cSVD on brain CT/MRI, Montreal Cognitive Assessment (MoCA) score 13-24 and preserved basic activities of living']","['remote ischaemic preconditioning', 'limb ischaemia-reperfusion', 'hindlimb remote ischaemic conditioning (RIC']","['safety/tolerability outcomes include the per cent of sessions completed and pain/discomfort scores', 'cerebral blood flow, decreasing white-matter injury and improving cognition', 'adherence', 'cerebral blood flow (per arterial spin-label MRI), white-matter hyperintensity volume, diffusion tensor imaging, MoCA and Trail-Making tests']","[{'cui': 'C3805043', 'cui_str': 'Vascular cognitive impairment'}, {'cui': 'C0242801', 'cui_str': 'Selection Criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C2733158', 'cui_str': 'Small vessel cerebrovascular disease'}, {'cui': 'C0412585', 'cui_str': 'Computerized axial tomography of brain'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]","[{'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C2945695', 'cui_str': 'Limb ischemia'}, {'cui': 'C0035124', 'cui_str': 'Reperfusion'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0562018', 'cui_str': 'cent'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0037914', 'cui_str': 'Spin Labels'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C1537007', 'cui_str': 'Diffusion Tensor MRI'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0040604', 'cui_str': 'Trail making test'}]",24.0,0.282651,"Efficacy outcomes include changes in cerebral blood flow (per arterial spin-label MRI), white-matter hyperintensity volume, diffusion tensor imaging, MoCA and Trail-Making tests.
","[{'ForeName': 'Aravind', 'Initials': 'A', 'LastName': 'Ganesh', 'Affiliation': 'Department of Clinical Neurosciences, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Barber', 'Affiliation': 'Department of Clinical Neurosciences, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Sandra E', 'Initials': 'SE', 'LastName': 'Black', 'Affiliation': 'Department of Medicine (Neurology), Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Dale', 'Initials': 'D', 'LastName': 'Corbett', 'Affiliation': 'Department of Cellular & Molecular Medicine, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Thalia S', 'Initials': 'TS', 'LastName': 'Field', 'Affiliation': 'Department of Medicine (Neurology), University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Frayne', 'Affiliation': 'Seaman Family MR Centre, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Hachinski', 'Affiliation': 'Department of Clinical Neurological Sciences, Western University, London, Ontario, Canada.'}, {'ForeName': 'Zahinoor', 'Initials': 'Z', 'LastName': 'Ismail', 'Affiliation': 'Department of Clinical Neurosciences, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Lauren M', 'Initials': 'LM', 'LastName': 'Mai', 'Affiliation': 'Department of Clinical Neurological Sciences, Western University, London, Ontario, Canada.'}, {'ForeName': 'Cheryl R', 'Initials': 'CR', 'LastName': 'McCreary', 'Affiliation': 'Department of Clinical Neurosciences and Radiology, University of Calgary Faculty of Medicine, Calgary, Alberta, Canada.'}, {'ForeName': 'Demetrios', 'Initials': 'D', 'LastName': 'Sahlas', 'Affiliation': 'Department of Medicine (Neurology), McMaster University Population Health Research Institute, Hamilton, Ontario, Canada.'}, {'ForeName': 'Mukul', 'Initials': 'M', 'LastName': 'Sharma', 'Affiliation': 'Department of Medicine (Neurology), McMaster University Population Health Research Institute, Hamilton, Ontario, Canada.'}, {'ForeName': 'Richard H', 'Initials': 'RH', 'LastName': 'Swartz', 'Affiliation': 'Department of Medicine (Neurology), Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Eric E', 'Initials': 'EE', 'LastName': 'Smith', 'Affiliation': 'Department of Clinical Neurosciences, University of Calgary, Calgary, Alberta, Canada eesmith@ucalgary.ca.'}]",BMJ open,['10.1136/bmjopen-2020-040466']
3337,33055336,MODERN METHODS OF PREVENTION AND TREATMENT OF COMPLICATIONS OF CERVICAL ESOPHAGO-ORGAN ANASTOMOSIS AT ESOPHAGOPLASTY.,"OBJECTIVE


The aim: To improve the results of operative treatment of esophageal strictures by decreasing the rate of failure and stricture of cervical esophago-organ anastomoses.
PATIENTS AND METHODS


Materials and methods: There were 45 patients with post-burn corrosive gullet strictures, 17 patients with postoperative corrosive strictures, 10 patients with peptic strictures secondary to reflux-esophagitis, 42 patients with esophageal cancer strictures. The patients were divided into two groups: the comparison group - 55 persons and the main group - 59 persons. Patients of comparison group underwent surgical treatment of esophageal strictures according to classic protocols and standards. In the main group of patients we applied proposed diagnostic algorithm with prediction of complication risk and the designed method of esophago-organ anastomosis formation.
RESULTS


Results: The results of operative treatment in patients with esophageal strictures showed the development of early postoperative complications in 59 individuals (51.75 %). In the postoperative period six patients died: four - in the comparison group and two - in the main group. Failure of cervical esophago-organ anastomosis and esophageal strictures occurred in 7 patients (11.86 %) of main group and 20 patients (36.36 %) of the comparison group (p<0.05).
CONCLUSION


Conclusions: Application of method predicting the risk of complications of cervical anastomosis, treatment program and instrumental method of formation anastomosis resulted in reduced incidence of failure and strictures of esophago-organ anastomosis from 36.36 % to 11.86 % (p<0.05); decreased time of hospitalization - from 28.2 ± 1.1 to 21.5 ± 0.5 bed-days (p<0.001), postoperative period - from 20.5 ± 1.1 to 16.1 ± 0.7 bed-days (p<0.01); decreased postoperative mortality - from 7.27 % to 3.39 %.",2020,"Failure of cervical esophago-organ anastomosis and esophageal strictures occurred in 7 patients (11.86 %) of main group and 20 patients (36.36 %) of the comparison group (p<0.05).
","['45 patients with post-burn corrosive gullet strictures, 17 patients with postoperative corrosive strictures, 10 patients with peptic strictures secondary to reflux-esophagitis, 42 patients with esophageal cancer strictures', 'patients with esophageal strictures']",['surgical treatment of esophageal strictures'],"['postoperative mortality', 'incidence of failure and strictures of esophago-organ anastomosis', 'Failure of cervical esophago-organ anastomosis and esophageal strictures', 'development of early postoperative complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0524525', 'cui_str': 'Corrosives'}, {'cui': 'C0014876', 'cui_str': 'Esophageal structure'}, {'cui': 'C1261287', 'cui_str': 'Stenosis'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0443277', 'cui_str': 'Peptic'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}, {'cui': 'C0014869', 'cui_str': 'Esophagitis, Reflux'}, {'cui': 'C0014859', 'cui_str': 'Neoplasm of esophagus'}, {'cui': 'C4551650', 'cui_str': 'Stricture of esophagus'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C4551650', 'cui_str': 'Stricture of esophagus'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C1261287', 'cui_str': 'Stenosis'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C4551650', 'cui_str': 'Stricture of esophagus'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}]",42.0,0.022756,"Failure of cervical esophago-organ anastomosis and esophageal strictures occurred in 7 patients (11.86 %) of main group and 20 patients (36.36 %) of the comparison group (p<0.05).
","[{'ForeName': 'Volodymyr O', 'Initials': 'VO', 'LastName': 'Shaprynskyi', 'Affiliation': 'NATIONAL PIROGOV MEMORIAL MEDICAL UNIVERSITY, VINNYTSIA, UKRAINE.'}, {'ForeName': 'Yevhen V', 'Initials': 'YV', 'LastName': 'Shaprynskyi', 'Affiliation': 'NATIONAL PIROGOV MEMORIAL MEDICAL UNIVERSITY, VINNYTSIA, UKRAINE.'}, {'ForeName': 'Mustafa Bassam', 'Initials': 'MB', 'LastName': 'Hussein', 'Affiliation': 'NATIONAL PIROGOV MEMORIAL MEDICAL UNIVERSITY, VINNYTSIA, UKRAINE.'}, {'ForeName': 'Oleg O', 'Initials': 'OO', 'LastName': 'Vorovskyi', 'Affiliation': 'NATIONAL PIROGOV MEMORIAL MEDICAL UNIVERSITY, VINNYTSIA, UKRAINE.'}, {'ForeName': 'Yaroslav V', 'Initials': 'YV', 'LastName': 'Karyi', 'Affiliation': 'NATIONAL PIROGOV MEMORIAL MEDICAL UNIVERSITY, VINNYTSIA, UKRAINE.'}, {'ForeName': 'Liudmyla A', 'Initials': 'LA', 'LastName': 'Shaprynska', 'Affiliation': 'NATIONAL PIROGOV MEMORIAL MEDICAL UNIVERSITY, VINNYTSIA, UKRAINE.'}, {'ForeName': 'Serhii P', 'Initials': 'SP', 'LastName': 'Dmytryshyn', 'Affiliation': 'NATIONAL PIROGOV MEMORIAL MEDICAL UNIVERSITY, VINNYTSIA, UKRAINE.'}]","Wiadomosci lekarskie (Warsaw, Poland : 1960)",[]
3338,33047991,A Comparative Evaluation of Diffractive Trifocal and New Refractive/Extended Depth of Focus Intraocular Lenses for Refractive Lens Exchange.,"PURPOSE


To evaluate and compare the visual performance and quality of life (QOL) associated with refractive/extended depth of focus (EDOF) intraocular lenses (IOLs) and diffractive trifocal IOLs in refractive lens exchange patients.
MATERIALS AND METHODS


This was a comparative interventional study of patients undergoing implantation of Lucidis (Swiss Advanced Vision, SAV‑IOL SA, Neuchâtel, Switzerland) or AT LISA tri 839MP (Carl Zeiss Meditec AG, Germany) IOLs. Near, intermediate, and distance best corrected and uncorrected visual acuities were collected at 1 and 3 months postoperatively. The vision-related QOL was evaluated 1 and 3 months after surgery, using the National Eye Institute Visual Function Questionnaire-14 (VF-14 QOL questionnaire).
RESULTS


A total of 74 patients underwent refractive lens exchange and IOL implantation, with 38 patients in the EDOF group and 36 in the trifocal group. Among all visual acuities, uncorrected near visual acuity was statistically significantly better with the Lucidis IOL at the first month ( p  = .02) and diminished at the third-month visit ( p  = .16). When we compared the VF-14 QOL questionnaire scores, reading small print, reading a newspaper or book, and driving at night were statistically significantly better in the Lucidis group at the first month ( p  = .00, for each). That difference persisted only in driving at night at the third-month visit ( p  = .04). Reading small print, driving at night, and doing fine handwork were the most difficult tasks in the AT LISA group at the first month, and only driving at night remained so at the third-month visit.
CONCLUSIONS


The refractive results and visual outcomes at all distances of EDOF and trifocal IOLs were highly satisfactory. However, the EDOF design in the Lucidis IOL achieves lower rates of glare in the early period after refractive lens exchange.",2020,"Among all visual acuities, uncorrected near visual acuity was statistically significantly better with the Lucidis IOL at the first month (p = 0.02) and diminished at the third month visit (p = 0.16).","['74 patients underwent refractive lens exchange and IOL implantation, with 38 patients in the EDOF group and 36 in the trifocal group', 'refractive lens exchange patients', 'patients undergoing implantation of Lucidis (Swiss Advanced Vision, SAV‑IOL SA, Neuchâtel, Switzerland) or AT LISA tri 839MP (Carl Zeiss Meditec AG, Germany) IOLs']","['diffractive trifocal and new refractive/extended depth of focus intraocular lenses', 'refractive/extended depth of focus (EDOF) intraocular lenses (IOLs']","['Near, intermediate, and distance best corrected and uncorrected visual acuities', 'vision-related QOL', 'VF-14 QOL questionnaire scores, reading small print, reading a newspaper or book, and driving at night', 'visual performance and quality of life (QOL', 'Reading small print, driving at night, and doing fine handwork', 'visual acuities, uncorrected near visual acuity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1532365', 'cui_str': 'Refractive lensectomy with intraocular lens implantation'}, {'cui': 'C0281658', 'cui_str': 'Intraocular Lymphoma'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0016400', 'cui_str': 'Focus Groups'}, {'cui': 'C1275646', 'cui_str': 'Trifocal glasses'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0241315', 'cui_str': 'Swiss'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0065404', 'cui_str': 'lysyl-5-fluorotryptophyl-lysine'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}]","[{'cui': 'C1275646', 'cui_str': 'Trifocal glasses'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}]","[{'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C1637380', 'cui_str': 'Uncorrected visual acuity'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0033161', 'cui_str': 'Printing'}, {'cui': 'C0027989', 'cui_str': 'Newspapers'}, {'cui': 'C0006002', 'cui_str': 'Book'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0205232', 'cui_str': 'Fine'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0429541', 'cui_str': 'Near visual acuity'}]",74.0,0.0300612,"Among all visual acuities, uncorrected near visual acuity was statistically significantly better with the Lucidis IOL at the first month (p = 0.02) and diminished at the third month visit (p = 0.16).","[{'ForeName': 'Kemal', 'Initials': 'K', 'LastName': 'Ozulken', 'Affiliation': 'Ophthalmology Department, TOBB ETU Medical School , Ankara, Turkey.'}, {'ForeName': 'Hasan', 'Initials': 'H', 'LastName': 'Kiziltoprak', 'Affiliation': ""Ophthalmology Department, Bingol Women's Health and Children's Hospital , Bingol, Turkey.""}, {'ForeName': 'Erdem', 'Initials': 'E', 'LastName': 'Yuksel', 'Affiliation': 'Ophthalmology Department, Kastamonu Medical School , Kastamonu, Turkey.'}, {'ForeName': 'Tarkan', 'Initials': 'T', 'LastName': 'Mumcuoğlu', 'Affiliation': 'Ophthalmology Department, TOBB ETU Medical School , Ankara, Turkey.'}]",Current eye research,['10.1080/02713683.2020.1833347']
3339,33048154,Effect of Sustained Smoking Cessation Counseling and Provision of Medication vs Shorter-term Counseling and Medication Advice on Smoking Abstinence in Patients Recently Diagnosed With Cancer: A Randomized Clinical Trial.,"Importance


Persistent smoking may cause adverse outcomes among patients with cancer. Many cancer centers have not fully implemented evidence-based tobacco treatment into routine care.
Objective


To determine the effectiveness of sustained telephone counseling and medication (intensive treatment) compared with shorter-term telephone counseling and medication advice (standard treatment) to assist patients recently diagnosed with cancer to quit smoking.
Design, Setting, and Participants


This unblinded randomized clinical trial was conducted at Massachusetts General Hospital/Dana-Farber/Harvard Cancer Center and Memorial Sloan Kettering Cancer Center. Adults who had smoked 1 cigarette or more within 30 days, spoke English or Spanish, and had recently diagnosed breast, gastrointestinal, genitourinary, gynecological, head and neck, lung, lymphoma, or melanoma cancers were eligible. Enrollment occurred between November 2013 and July 2017; assessments were completed by the end of February 2018.
Interventions


Participants randomized to the intensive treatment (n = 153) and the standard treatment (n = 150) received 4 weekly telephone counseling sessions and medication advice. The intensive treatment group also received 4 biweekly and 3 monthly telephone counseling sessions and choice of Food and Drug Administration-approved cessation medication (nicotine replacement therapy, bupropion, or varenicline).
Main Outcome and Measures


The primary outcome was biochemically confirmed 7-day point prevalence tobacco abstinence at 6-month follow-up. Secondary outcomes were treatment utilization rates.
Results


Among 303 patients who were randomized (mean age, 58.3 years; 170 women [56.1%]), 221 (78.1%) completed the trial. Six-month biochemically confirmed quit rates were 34.5% (n = 51 in the intensive treatment group) vs 21.5% (n = 29 in the standard treatment group) (difference, 13.0% [95% CI, 3.0%-23.3%]; odds ratio, 1.92 [95% CI, 1.13-3.27]; P < .02). The median number of counseling sessions completed was 8 (interquartile range, 4-11) in the intensive treatment group. A total of 97 intensive treatment participants (77.0%) vs 68 standard treatment participants (59.1%) reported cessation medication use (difference, 17.9% [95% CI, 6.3%-29.5%]; odds ratio, 2.31 [95% CI, 1.32-4.04]; P = .003). The most common adverse events in the intensive treatment and standard treatment groups, respectively, were nausea (n = 13 and n = 6), rash (n = 4 and n = 1), hiccups (n = 4 and n = 1), mouth irritation (n = 4 and n = 0), difficulty sleeping (n = 3 and n = 2), and vivid dreams (n = 3 and n = 2).
Conclusions and Relevance


Among smokers recently diagnosed with cancer in 2 National Cancer Institute-designated Comprehensive Cancer Centers, sustained counseling and provision of free cessation medication compared with 4-week counseling and medication advice resulted in higher 6-month biochemically confirmed quit rates. However, the generalizability of the study findings is uncertain and requires further research.
Trial Registration


ClinicalTrials.gov Identifier: NCT01871506.",2020,"Six-month biochemically confirmed quit rates were 34.5% (n = 51 in the intensive treatment group) vs 21.5% (n = 29 in the standard treatment group) (difference, 13.0% [95% CI, 3.0%-23.3%]; odds ratio, 1.92 [95% CI, 1.13-3.27]; P < .02).","['Adults who had smoked 1 cigarette or more within 30 days, spoke English or Spanish, and had recently diagnosed breast, gastrointestinal, genitourinary, gynecological, head and neck, lung, lymphoma, or melanoma cancers were eligible', 'Massachusetts General Hospital/Dana-Farber/Harvard Cancer Center and Memorial Sloan Kettering Cancer Center', 'Patients Recently Diagnosed With Cancer', 'patients recently diagnosed with cancer to quit smoking', '303 patients who were randomized (mean age, 58.3 years; 170 women [56.1%]), 221 (78.1%) completed the trial', 'patients with cancer']","['Sustained Smoking Cessation Counseling and Provision of Medication vs Shorter-term Counseling and Medication Advice', 'sustained telephone counseling and medication (intensive treatment', 'intensive treatment (n\u2009=\u2009153) and the standard treatment (n\u2009=\u2009150) received 4 weekly telephone counseling sessions and medication advice', 'shorter-term telephone counseling and medication advice (standard treatment', 'telephone counseling sessions and choice of Food and Drug Administration-approved cessation medication (nicotine replacement therapy, bupropion, or varenicline']","['quit rates', 'treatment utilization rates', 'Smoking Abstinence', 'median number of counseling sessions', 'mouth irritation', 'nausea', 'cessation medication use', '7-day point prevalence tobacco abstinence']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0234856', 'cui_str': 'Speaking'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0042066', 'cui_str': 'Structure of genitourinary system'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0460004', 'cui_str': 'Structure of head and/or neck'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0024299', 'cui_str': 'Malignant lymphoma'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0024874', 'cui_str': 'Massachusetts'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0268255', 'cui_str': ""Farber's lipogranulomatosis""}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0041714', 'cui_str': 'United States Food, Drug Administration'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0085208', 'cui_str': 'Bupropion'}, {'cui': 'C1569608', 'cui_str': 'varenicline'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0235339', 'cui_str': 'Mouth irritation'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}]",2.0,0.152051,"Six-month biochemically confirmed quit rates were 34.5% (n = 51 in the intensive treatment group) vs 21.5% (n = 29 in the standard treatment group) (difference, 13.0% [95% CI, 3.0%-23.3%]; odds ratio, 1.92 [95% CI, 1.13-3.27]; P < .02).","[{'ForeName': 'Elyse R', 'Initials': 'ER', 'LastName': 'Park', 'Affiliation': 'Health Policy Research Center, Mongan Institute, Massachusetts General Hospital, Boston.'}, {'ForeName': 'Giselle K', 'Initials': 'GK', 'LastName': 'Perez', 'Affiliation': 'Health Policy Research Center, Mongan Institute, Massachusetts General Hospital, Boston.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Regan', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Alona', 'Initials': 'A', 'LastName': 'Muzikansky', 'Affiliation': 'MGH Biostatistics Center, Massachusetts General Hospital, Boston.'}, {'ForeName': 'Douglas E', 'Initials': 'DE', 'LastName': 'Levy', 'Affiliation': 'Health Policy Research Center, Mongan Institute, Massachusetts General Hospital, Boston.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Temel', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Nancy A', 'Initials': 'NA', 'LastName': 'Rigotti', 'Affiliation': 'Health Policy Research Center, Mongan Institute, Massachusetts General Hospital, Boston.'}, {'ForeName': 'William F', 'Initials': 'WF', 'LastName': 'Pirl', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Kelly E', 'Initials': 'KE', 'LastName': 'Irwin', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Ann H', 'Initials': 'AH', 'LastName': 'Partridge', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'Cooley', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Emily R', 'Initials': 'ER', 'LastName': 'Friedman', 'Affiliation': 'Health Policy Research Center, Mongan Institute, Massachusetts General Hospital, Boston.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Rabin', 'Affiliation': 'Health Policy Research Center, Mongan Institute, Massachusetts General Hospital, Boston.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Ponzani', 'Affiliation': 'Health Policy Research Center, Mongan Institute, Massachusetts General Hospital, Boston.'}, {'ForeName': 'Kelly A', 'Initials': 'KA', 'LastName': 'Hyland', 'Affiliation': 'Department of Health Outcomes and Behavior, Moffitt Cancer Center, Tampa, Florida.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Holland', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Tobacco Treatment Program, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Borderud', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Tobacco Treatment Program, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Sprunck', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Kwon', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Tobacco Treatment Program, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Peterson', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Tobacco Treatment Program, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Miller-Sobel', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Tobacco Treatment Program, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Gonzalez', 'Affiliation': 'Health Policy Research Center, Mongan Institute, Massachusetts General Hospital, Boston.'}, {'ForeName': 'C Will', 'Initials': 'CW', 'LastName': 'Whitlock', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Tobacco Treatment Program, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Malloy', 'Affiliation': 'Benson-Henry Institute for Mind Body Medicine, Massachusetts General Hospital, Boston.'}, {'ForeName': 'Suhana', 'Initials': 'S', 'LastName': 'de León-Sanchez', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Tobacco Treatment Program, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': ""O'Brien"", 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Tobacco Treatment Program, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Jamie S', 'Initials': 'JS', 'LastName': 'Ostroff', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Tobacco Treatment Program, Memorial Sloan Kettering Cancer Center, New York, New York.'}]",JAMA,['10.1001/jama.2020.14581']
3340,33048195,"Viscoelastic haemostatic assay augmented protocols for major trauma haemorrhage (ITACTIC): a randomized, controlled trial.","PURPOSE


Contemporary trauma resuscitation prioritizes control of bleeding and uses major haemorrhage protocols (MHPs) to prevent and treat coagulopathy. We aimed to determine whether augmenting MHPs with Viscoelastic Haemostatic Assays (VHA) would improve outcomes compared to Conventional Coagulation Tests (CCTs).
METHODS


This was a multi-centre, randomized controlled trial comparing outcomes in trauma patients who received empiric MHPs, augmented by either VHA or CCT-guided interventions. Primary outcome was the proportion of subjects who, at 24 h after injury, were alive and free of massive transfusion (10 or more red cell transfusions). Secondary outcomes included 28-day mortality. Pre-specified subgroups included patients with severe traumatic brain injury (TBI).
RESULTS


Of 396 patients in the intention to treat analysis, 201 were allocated to VHA and 195 to CCT-guided therapy. At 24 h, there was no difference in the proportion of patients who were alive and free of massive transfusion (VHA: 67%, CCT: 64%, OR 1.15, 95% CI 0.76-1.73). 28-day mortality was not different overall (VHA: 25%, CCT: 28%, OR 0.84, 95% CI 0.54-1.31), nor were there differences in other secondary outcomes or serious adverse events. In pre-specified subgroups, there were no differences in primary outcomes. In the pre-specified subgroup of 74 patients with TBI, 64% were alive and free of massive transfusion at 24 h compared to 46% in the CCT arm (OR 2.12, 95% CI 0.84-5.34).
CONCLUSION


There was no difference in overall outcomes between VHA- and CCT-augmented-major haemorrhage protocols.",2020,"28-day mortality was not different overall (VHA: 25%, CCT: 28%, OR 0.84, 95% CI 0.54-1.31), nor were there differences in other secondary outcomes or serious adverse events.","['patients with severe traumatic brain injury (TBI', 'trauma patients who received empiric MHPs, augmented by either VHA or CCT-guided interventions', '396 patients in the intention to treat analysis', 'major trauma haemorrhage (ITACTIC']","['Viscoelastic haemostatic assay augmented protocols', 'MHPs with Viscoelastic Haemostatic Assays (VHA', 'CCT-guided therapy']","['proportion of subjects who, at 24\xa0h after injury, were alive and free of massive transfusion', '28-day mortality', 'alive and free of massive transfusion', 'overall outcomes between VHA- and CCT-augmented-major haemorrhage protocols', 'serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C4049005', 'cui_str': 'Cataract, total congenital with posterior sutural opacities in Heterozygotes'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C5191354', 'cui_str': '396'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0332677', 'cui_str': 'Major injury'}]","[{'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C4049005', 'cui_str': 'Cataract, total congenital with posterior sutural opacities in Heterozygotes'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0522501', 'cui_str': 'Massive'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C4049005', 'cui_str': 'Cataract, total congenital with posterior sutural opacities in Heterozygotes'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",74.0,0.186377,"28-day mortality was not different overall (VHA: 25%, CCT: 28%, OR 0.84, 95% CI 0.54-1.31), nor were there differences in other secondary outcomes or serious adverse events.","[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Baksaas-Aasen', 'Affiliation': 'Oslo University Hospital & University of Oslo, Oslo, Norway.'}, {'ForeName': 'L S', 'Initials': 'LS', 'LastName': 'Gall', 'Affiliation': 'Centre for Trauma Sciences, Queen Mary University of London, Blizard Institute, 4 Newark Street, London, E1 2AT, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Stensballe', 'Affiliation': 'Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'N P', 'Initials': 'NP', 'LastName': 'Juffermans', 'Affiliation': 'Amsterdam University Medical Centres, Amsterdam, The Netherlands.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Curry', 'Affiliation': 'Oxford University Hospital NHS Trust, Oxford, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Maegele', 'Affiliation': 'Cologne-Merheim Medical Centre, University of Witten/Herdecke, Cologne, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Brooks', 'Affiliation': 'Nottingham University Hospitals NHS Trust, Nottingham, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Rourke', 'Affiliation': 'Centre for Trauma Sciences, Queen Mary University of London, Blizard Institute, 4 Newark Street, London, E1 2AT, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Gillespie', 'Affiliation': 'Centre for Trauma Sciences, Queen Mary University of London, Blizard Institute, 4 Newark Street, London, E1 2AT, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Murphy', 'Affiliation': 'Queen Mary University of London, London, UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Maroni', 'Affiliation': 'Queen Mary University of London, London, UK.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Vulliamy', 'Affiliation': 'Centre for Trauma Sciences, Queen Mary University of London, Blizard Institute, 4 Newark Street, London, E1 2AT, UK.'}, {'ForeName': 'H H', 'Initials': 'HH', 'LastName': 'Henriksen', 'Affiliation': 'Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'K Holst', 'Initials': 'KH', 'LastName': 'Pedersen', 'Affiliation': 'Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'K M', 'Initials': 'KM', 'LastName': 'Kolstadbraaten', 'Affiliation': 'Oslo University Hospital & University of Oslo, Oslo, Norway.'}, {'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'Wirtz', 'Affiliation': 'Amsterdam University Medical Centres, Amsterdam, The Netherlands.'}, {'ForeName': 'D J B', 'Initials': 'DJB', 'LastName': 'Kleinveld', 'Affiliation': 'Amsterdam University Medical Centres, Amsterdam, The Netherlands.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Schäfer', 'Affiliation': 'Cologne-Merheim Medical Centre, University of Witten/Herdecke, Cologne, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Chinna', 'Affiliation': 'Nottingham University Hospitals NHS Trust, Nottingham, UK.'}, {'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Davenport', 'Affiliation': 'Centre for Trauma Sciences, Queen Mary University of London, Blizard Institute, 4 Newark Street, London, E1 2AT, UK.'}, {'ForeName': 'P A', 'Initials': 'PA', 'LastName': 'Naess', 'Affiliation': 'Oslo University Hospital & University of Oslo, Oslo, Norway.'}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Goslings', 'Affiliation': 'Amsterdam University Medical Centres, Amsterdam, The Netherlands.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Eaglestone', 'Affiliation': 'Centre for Trauma Sciences, Queen Mary University of London, Blizard Institute, 4 Newark Street, London, E1 2AT, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Stanworth', 'Affiliation': 'Oxford University Hospital NHS Trust, Oxford, UK.'}, {'ForeName': 'P I', 'Initials': 'PI', 'LastName': 'Johansson', 'Affiliation': 'Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Gaarder', 'Affiliation': 'Oslo University Hospital & University of Oslo, Oslo, Norway.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Brohi', 'Affiliation': 'Centre for Trauma Sciences, Queen Mary University of London, Blizard Institute, 4 Newark Street, London, E1 2AT, UK. k.brohi@qmul.ac.uk.'}]",Intensive care medicine,['10.1007/s00134-020-06266-1']
3341,33050928,"SOURCE: a phase 3, multicentre, randomized, double-blind, placebo-controlled, parallel group trial to evaluate the efficacy and safety of tezepelumab in reducing oral corticosteroid use in adults with oral corticosteroid dependent asthma.","BACKGROUND


Many patients with severe asthma continue to experience asthma symptoms and exacerbations despite standard-of-care treatment. A substantial proportion of these patients require long-term treatment with oral corticosteroids (OCS), often at high doses, which are associated with considerable multiorgan adverse effects, including metabolic disorders, osteoporosis and adrenal insufficiency. Tezepelumab is a human monoclonal antibody that blocks the activity of the epithelial cytokine thymic stromal lymphopoietin. In the PATHWAY phase 2b study (NCT02054130), tezepelumab significantly reduced exacerbations by up to 71% in adults with severe, uncontrolled asthma. Several ongoing phase 3 trials (SOURCE, NCT03406078; NAVIGATOR, NCT03347279; DESTINATION, NCT03706079) are assessing the efficacy and safety of tezepelumab in patients with severe, uncontrolled asthma. Here, we describe the design and objectives of SOURCE, a phase 3 OCS-sparing study.
METHODS


SOURCE is an ongoing phase 3, multicentre, randomized, double-blind, placebo-controlled study to evaluate the effect of tezepelumab 210 mg administered subcutaneously every 4 weeks on OCS dose reduction in adults with OCS-dependent asthma. The study comprises a 2-week screening and enrolment period, followed by an OCS optimization phase of up to 8 weeks and a 48-week treatment period, which consists of a 4-week induction phase, followed by a 36-week OCS reduction phase and an 8-week maintenance phase. The primary objective is to assess the effect of tezepelumab compared with placebo in reducing the prescribed OCS maintenance dose. The key secondary objective is to assess the effect of tezepelumab on asthma exacerbation rates. Other secondary objectives include the proportion of patients with a reduction in OCS dose (100% or 50% reduction or those receiving < 5 mg) and the effect of tezepelumab on lung function and patient-reported outcomes.
CONCLUSIONS


SOURCE is evaluating the OCS-sparing potential of tezepelumab in patients with OCS-dependent asthma. SOURCE also aims to demonstrate that treatment with tezepelumab in patients with severe asthma is associated with reductions in exacerbation rates and improvements in lung function, asthma control and health-related quality of life, while reducing OCS dose.
TRIAL REGISTRATION


NCT03406078 ( ClinicalTrials.gov ). Registered 23 January 2018. https://clinicaltrials.gov/ct2/show/NCT03406078.",2020,Tezepelumab is a human monoclonal antibody that blocks the activity of the epithelial cytokine thymic stromal lymphopoietin.,"['adults with OCS-dependent asthma', 'patients with OCS-dependent asthma', 'patients with severe, uncontrolled asthma', 'patients with severe asthma', 'adults with oral corticosteroid dependent asthma', 'adults with severe, uncontrolled asthma']","['oral corticosteroids (OCS', 'Tezepelumab', 'placebo', 'tezepelumab']","['efficacy and safety', 'asthma exacerbation rates', 'exacerbation rates and improvements in lung function, asthma control and health-related quality of life', 'proportion of patients with a reduction in OCS dose']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0581126', 'cui_str': 'Severe asthma'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C4550163', 'cui_str': 'tezepelumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0349790', 'cui_str': 'Exacerbation of asthma'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]",,0.236054,Tezepelumab is a human monoclonal antibody that blocks the activity of the epithelial cytokine thymic stromal lymphopoietin.,"[{'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Wechsler', 'Affiliation': 'National Jewish Health, Denver, CO, USA. mikewechsler@gmail.com.'}, {'ForeName': 'Gene', 'Initials': 'G', 'LastName': 'Colice', 'Affiliation': 'Respiratory & Immunology, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Janet M', 'Initials': 'JM', 'LastName': 'Griffiths', 'Affiliation': 'Translational Science and Experimental Medicine, Research and Early Development, Respiratory & Immunology, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Gun', 'Initials': 'G', 'LastName': 'Almqvist', 'Affiliation': 'Late Respiratory & Immunology, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Tor', 'Initials': 'T', 'LastName': 'Skärby', 'Affiliation': 'Late Respiratory & Immunology, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Piechowiak', 'Affiliation': 'Development Operations, BioPharmaceuticals R&D, AstraZeneca, Mississauga, ON, Canada.'}, {'ForeName': 'Primal', 'Initials': 'P', 'LastName': 'Kaur', 'Affiliation': 'Amgen, Thousand Oaks, CA, USA.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Bowen', 'Affiliation': 'Biometrics, Late Respiratory & Immunology, BioPharmaceuticals R&D, Gaithersburg, MD, USA.'}, {'ForeName': 'Åsa', 'Initials': 'Å', 'LastName': 'Hellqvist', 'Affiliation': 'Biometrics, Late Respiratory & Immunology, BioPharmaceuticals R&D, Gothenburg, Sweden.'}, {'ForeName': 'May', 'Initials': 'M', 'LastName': 'Mo', 'Affiliation': 'Amgen, Thousand Oaks, CA, USA.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Garcia Gil', 'Affiliation': 'Global Medical Respiratory, BioPharmaceuticals R&D, AstraZeneca, Barcelona, Spain.'}]",Respiratory research,['10.1186/s12931-020-01503-z']
3342,33050931,Empagliflozin reduced long-term HbA1c variability and cardiovascular death: insights from the EMPA-REG OUTCOME trial.,"BACKGROUND


Glucose variability has been associated with cardiovascular outcomes in type 2 diabetes, however, the interplay between glucose variability, empagliflozin and cardiovascular death has not been explored. In the EMPA-REG OUTCOME trial, empagliflozin reduced the risk of cardiovascular death by 38%. We explore post-hoc the association between HbA1c variability and cardiovascular death, and the potential mediating effects of HbA1c variability on empagliflozin's cardiovascular death reductions.
METHODS


In total, 7,020 patients with type 2 diabetes and established cardiovascular disease received placebo, empagliflozin 10 mg or 25 mg. We defined within-patient HbA1c variability as standard deviation, coefficient of variation and range of HbA1c measurements (%) post-baseline. First, we compared HbA1c variability until week 28 and 52 by Wilcoxon tests. We explored the association between cardiovascular death and HbA1c variability in placebo and pooled empagliflozin arms separately with landmark analyses at week 28 and 52, and additionally with HbA1c variability as a time-dependent co-variate. We used Cox regression models adjusted for baseline risk factors including changes in HbA1c from baseline to week 12, and the interaction term HbA1c variability* treatment.
RESULTS


HbA1c variability was lower with empagliflozin compared to placebo. In all Cox analyses, high HbA1c variability increased the risk for cardiovascular death in both treatment arms with no interaction with treatment: e.g. an increase in HbA1c variability of one unit for the standard deviation at week 28 was associated with a subsequent increased risk of CV death with HRs of 1.97 (95% CI 1.36, 2.84) and 1.53 (1.01, 2.31) in the placebo and empagliflozin groups, separately, interaction p-value 0.3615.
CONCLUSIONS


HbA1c variability was reduced by empagliflozin and high values of HbA1c variability were associated with an increased risk of cardiovascular death. Empagliflozin's reduction in cardiovascular death did not appear to be mediated by reductions in HbA1c variability. ClinicalTrials.gov number, NCT01131676.",2020,"In all Cox analyses, high HbA1c variability increased the risk for cardiovascular death in both treatment arms with no interaction with treatment: e.g. an increase in HbA1c variability of one unit for the standard deviation at week 28 was associated with a subsequent increased risk of CV death with HRs of 1.97 (95% CI 1.36, 2.84) and 1.53 (1.01, 2.31) in the placebo and empagliflozin groups, separately, interaction p-value 0.3615.
","['7,020 patients with type 2 diabetes and established cardiovascular disease received']","['empagliflozin', 'placebo, empagliflozin 10\xa0mg or 25\xa0mg', 'placebo and pooled empagliflozin', 'placebo', 'Empagliflozin']","['HbA1c variability', 'risk of CV death', 'risk of cardiovascular death', 'cardiovascular death and HbA1c variability', 'cardiovascular death', 'long-term HbA1c variability and cardiovascular death']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}]","[{'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3848773', 'cui_str': 'empagliflozin 10 MG [Jardiance]'}, {'cui': 'C0337051', 'cui_str': 'Pool'}]","[{'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]",7020.0,0.344366,"In all Cox analyses, high HbA1c variability increased the risk for cardiovascular death in both treatment arms with no interaction with treatment: e.g. an increase in HbA1c variability of one unit for the standard deviation at week 28 was associated with a subsequent increased risk of CV death with HRs of 1.97 (95% CI 1.36, 2.84) and 1.53 (1.01, 2.31) in the placebo and empagliflozin groups, separately, interaction p-value 0.3615.
","[{'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Ceriello', 'Affiliation': 'IRCCS MultiMedica, Milan, Italy. antonio.ceriello@hotmail.it.'}, {'ForeName': 'Anne Pernille', 'Initials': 'AP', 'LastName': 'Ofstad', 'Affiliation': 'Boehringer Ingelheim Norway KS, Asker, Norway.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Zwiener', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Kaspers', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Jyothis', 'Initials': 'J', 'LastName': 'George', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Nicolucci', 'Affiliation': 'Center for Outcomes Research and Clinical Epidemiology, Pescara, Italy.'}]",Cardiovascular diabetology,['10.1186/s12933-020-01147-9']
3343,33050934,"NAVIGATOR: a phase 3 multicentre, randomized, double-blind, placebo-controlled, parallel-group trial to evaluate the efficacy and safety of tezepelumab in adults and adolescents with severe, uncontrolled asthma.","BACKGROUND


Patients with severe, uncontrolled asthma have a significant unmet need for new treatments that have broader effects on airway inflammation, and that provide greater improvements in asthma outcomes than currently approved biologics and standard-of-care therapies. Tezepelumab is a human monoclonal antibody that blocks the activity of the epithelial cytokine thymic stromal lymphopoietin. In the PATHWAY phase 2b study (NCT02054130), tezepelumab significantly reduced exacerbations by up to 71% in adults with severe, uncontrolled asthma, irrespective of baseline disease phenotype. This article reports the design and objectives of the pivotal phase 3 NAVIGATOR study.
METHODS


NAVIGATOR (NCT03347279) is an ongoing randomized, double-blind, placebo-controlled trial in adults (18-80 years old) and adolescents (12-17 years old) with severe, uncontrolled asthma, who are receiving treatment with medium- or high-dose inhaled corticosteroids plus at least one additional controller medication with or without oral corticosteroids (N = 1061). The study population includes approximately equal proportions of patients with high (≥ 300 cells/μL) and low (< 300 cells/μL) blood eosinophil counts. The study comprises a 5-6-week screening period, a 52-week treatment period and a 12-week post-treatment follow-up period. All patients will receive their prescribed controller medications without change throughout the study. The primary efficacy endpoint is the annualized asthma exacerbation rate during the 52-week treatment period. Key secondary endpoints include the effect of tezepelumab on lung function, asthma control and health-related quality of life.
DISCUSSION


NAVIGATOR is evaluating the effect of tezepelumab in patients with a broad range of severe asthma phenotypes at baseline, including those with low blood eosinophil counts. The target sample size for NAVIGATOR (N = 1060) was achieved, and it is the largest clinical study of tezepelumab in severe, uncontrolled asthma to date. NAVIGATOR aims to further investigate the effect of tezepelumab on exacerbations and build on observations from the phase 2b PATHWAY study, and to demonstrate further the potential of tezepelumab to provide patients with severe, uncontrolled asthma with improvements in lung function, asthma control and health-related quality of life.
TRIAL REGISTRATION


NCT03347279 (ClinicalTrials.gov). Registered 20 November 2017.",2020,Tezepelumab is a human monoclonal antibody that blocks the activity of the epithelial cytokine thymic stromal lymphopoietin.,"['Patients with severe, uncontrolled asthma', 'patients with high (≥ 300 cells/μL) and low (<\u2009300 cells/μL) blood eosinophil counts', 'patients with severe, uncontrolled asthma with improvements in lung function, asthma control and health-related quality of life', 'adults (18-80\u2009years old) and adolescents (12-17\u2009years old) with severe, uncontrolled asthma, who are receiving treatment with medium- or high-dose inhaled corticosteroids plus at least one additional controller medication with or without oral corticosteroids (N\u2009=\u20091061', 'adults with severe, uncontrolled asthma, irrespective of baseline disease phenotype', 'adults and adolescents with severe, uncontrolled asthma']","['Tezepelumab', 'placebo', 'tezepelumab']","['efficacy and safety', 'annualized asthma exacerbation rate', 'effect of tezepelumab on lung function, asthma control and health-related quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0200638', 'cui_str': 'Eosinophil count'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0031437', 'cui_str': 'Phenotype'}]","[{'cui': 'C4550163', 'cui_str': 'tezepelumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0349790', 'cui_str': 'Exacerbation of asthma'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C4550163', 'cui_str': 'tezepelumab'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.224993,Tezepelumab is a human monoclonal antibody that blocks the activity of the epithelial cytokine thymic stromal lymphopoietin.,"[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Menzies-Gow', 'Affiliation': 'Royal Brompton Hospital, Sydney Street, London, SW3 6NP, UK. A.Menzies-Gow@rbht.nhs.uk.'}, {'ForeName': 'Gene', 'Initials': 'G', 'LastName': 'Colice', 'Affiliation': 'Late Respiratory & Immunology, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Janet M', 'Initials': 'JM', 'LastName': 'Griffiths', 'Affiliation': 'Translational Science and Experimental Medicine, Early Respiratory & Immunology, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Gun', 'Initials': 'G', 'LastName': 'Almqvist', 'Affiliation': 'Late Respiratory & Immunology, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Sandhia', 'Initials': 'S', 'LastName': 'Ponnarambil', 'Affiliation': 'Late Respiratory & Immunology, BioPharmaceuticals R&D, AstraZeneca, Cambridge, UK.'}, {'ForeName': 'Primal', 'Initials': 'P', 'LastName': 'Kaur', 'Affiliation': 'Amgen, Thousand Oaks, CA, USA.'}, {'ForeName': 'Gennaro', 'Initials': 'G', 'LastName': 'Ruberto', 'Affiliation': 'BioPharma Study Management, Late Respiratory & Immunology, BioPharmaceuticals R&D, AstraZeneca, Mississauga, ON, Canada.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Bowen', 'Affiliation': 'Biometrics, Late Respiratory & Immunology, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Åsa', 'Initials': 'Å', 'LastName': 'Hellqvist', 'Affiliation': 'Biometrics, Late Respiratory & Immunology, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'May', 'Initials': 'M', 'LastName': 'Mo', 'Affiliation': 'Amgen, Thousand Oaks, CA, USA.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Garcia Gil', 'Affiliation': 'Global Medical Respiratory, BioPharmaceuticals Medical, AstraZeneca, Barcelona, Spain.'}]",Respiratory research,['10.1186/s12931-020-01526-6']
3344,33050945,The Efficacy of Famotidine in improvement of outcomes in Hospitalized COVID-19 Patients: A structured summary of a study protocol for a randomised controlled trial.,"OBJECTIVES


This study aims to investigate the effect of Famotidine on the recovery process of COVID-19 patients.
TRIAL DESIGN


This phase III randomized clinical trial was designed with two parallel arms, placebo-controlled, single-blind, and concealed allocation.
PARTICIPANTS


All COVID-19 patients admitted to Shahid Mohammadi Hospital in Bandar Abbas whose PCR test results are positive for SARS-Cov-2 and sign the written consent of the study are included in the study and immunocompromised patients, end-stage renal disease, moderate renal failure (clearance Creatinine 30 to 50 ml/min) or stage 4 severe chronic kidney disease or need for dialysis (creatinine clearance lesser than 30 ml/min), history of liver disease, hepatitis C infection or alcoholism, Glucose 6 phosphate dehydrogenase deficiency(G6PD), the ratio of Alanine transaminase to Aspartate transaminase 5 times above the normal limit, history or evidence of long QT segment on Electrocardiogram, psoriasis or porphyria, pregnancy, use of oral contraceptives, Dasatinib, Neratinib, Ozanimod, Pazopanib, Rilpivirine, Siponimod and/or Tizanidine and allergies to any study drug are excluded.
INTERVENTION AND COMPARATOR


Intervention group receives standard pharmacotherapy according to the treatment protocols of the National Committee of COVID-19 and oral famotidine 160 mg (Manufactured by Chemidarou Pharmaceutical Company) four times a day until the day of discharge, for a maximum of fourteen days. Comparator group receives standard drug therapy according to the treatment protocols of the National Committee of COVID-19 and placebo in the same dosage.
MAIN OUTCOMES


Patients' temperature, respiration rate, oxygen saturation, lung infiltration, lactate dehydrogenase and complete blood count were measured at the baseline (before the intervention) and on day 14 after the intervention or on the discharge day.
RANDOMISATION


The person who has no role in admitting patients and assigning patients to random codes preparing random sequences using online tools and by permuted block randomization method. Eligibility criteria are monitored by the person responsible for admitting patients. Codes in a random sequence are assigned to patients by the treatment team without knowing that each code is in the intervention or comparator group. Patient codes are then matched to randomly generated sequence information for interventions.
BLINDING (MASKING)


All participants are unaware of which group of this study they are in and after grouping patients in the groups, Patients receive Famotidine in the treatment group and receive a placebo in the control group. The lead researcher, care givers, data collectors, and outcome assessors are aware of the grouping of patients.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)


As there is no prior work on this research question, so no assumptions for the sample size calculation could be made. A total of 20 patients participate in this study, which are randomly divided into two groups of 10 as intervention or control groups.
TRIAL STATUS


Version 3 of the protocol was approved by the Deputy of Research and Technology and the ethics committee of Hormozgan University of Medical Sciences on August 2, 2020, with the local code 990245, and the recruitment started on August 17, 2020. recruitment ended on August 31, 2020. Since the recruitment ended earlier than expected (the expected recruitment end date was 21/12/2020), we submitted post recruitment but prior to publication of the results.
TRIAL REGISTRATION


The protocol was registered before starting subject recruitment under the title: The effect of Famotidine on the improvement of patients with COVID-19, IRCT20200509047364N2, at Iranian Registry of clinical trials ( https://www.irct.ir/trial/49657 ) on 17 August 2020.
FULL PROTOCOL


The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2).",2020,"The effect of Famotidine on the improvement of patients with COVID-19, IRCT20200509047364N2, at Iranian Registry of clinical trials ( https://www.irct.ir/trial/49657 ) on 17 August 2020.
","['20 patients participate in this study', 'immunocompromised patients, end-stage renal disease, moderate renal failure (clearance Creatinine 30 to 50 ml/min) or stage 4 severe chronic kidney disease or need for dialysis (creatinine clearance lesser than 30 ml/min), history of liver disease, hepatitis C infection or alcoholism, Glucose 6 phosphate dehydrogenase deficiency(G6PD), the ratio of Alanine transaminase to Aspartate transaminase 5 times above the normal limit, history or evidence of long QT segment on Electrocardiogram, psoriasis or porphyria, pregnancy, use of oral contraceptives, Dasatinib, Neratinib, Ozanimod', 'Version 3 of the protocol was approved by the Deputy of Research and Technology and the ethics committee of Hormozgan University of Medical Sciences on August 2, 2020, with the local code 990245, and the recruitment started on August 17, 2020', 'All COVID-19 patients admitted to Shahid Mohammadi Hospital in Bandar Abbas', 'Hospitalized COVID-19 Patients', 'patients with COVID-19, IRCT20200509047364N2, at Iranian Registry of clinical trials ( https://www.irct.ir/trial/49657 ) on 17 August 2020', 'COVID-19 patients']","['COVID-19 and placebo', 'placebo', 'COVID-19 and oral famotidine 160 mg (Manufactured by Chemidarou Pharmaceutical Company', 'Pazopanib, Rilpivirine', 'Famotidine']","['temperature, respiration rate, oxygen saturation, lung infiltration, lactate dehydrogenase and complete blood count']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0455550', 'cui_str': 'H/O: liver disease'}, {'cui': 'C0019196', 'cui_str': 'Viral hepatitis C'}, {'cui': 'C0001973', 'cui_str': 'Alcohol dependence'}, {'cui': 'C0017757', 'cui_str': 'Glucose-6-phosphate dehydrogenase'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C1291311', 'cui_str': 'Deficiency of dehydrogenase'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0442816', 'cui_str': 'Normal limits'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0151878', 'cui_str': 'Prolonged QT interval'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0032708', 'cui_str': 'Disorder of porphyrin metabolism'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C1455147', 'cui_str': 'dasatinib'}, {'cui': 'C2713008', 'cui_str': 'neratinib'}, {'cui': 'C4278675', 'cui_str': 'ozanimod'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0085546', 'cui_str': 'Ethics Committees'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0009219', 'cui_str': 'Coding'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0015620', 'cui_str': 'Famotidine'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0013058', 'cui_str': 'Pharmaceutical dose form'}, {'cui': 'C1831796', 'cui_str': 'pazopanib'}, {'cui': 'C1566826', 'cui_str': 'Rilpivirine'}]","[{'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0235896', 'cui_str': 'Lung infiltration'}, {'cui': 'C0022917', 'cui_str': 'Lactate dehydrogenase'}, {'cui': 'C0009555', 'cui_str': 'Complete blood count'}]",20.0,0.0960359,"The effect of Famotidine on the improvement of patients with COVID-19, IRCT20200509047364N2, at Iranian Registry of clinical trials ( https://www.irct.ir/trial/49657 ) on 17 August 2020.
","[{'ForeName': 'Hamid Reza', 'Initials': 'HR', 'LastName': 'Samimagham', 'Affiliation': 'Clinical Research Development Center, Shahid Mohammadi Hospital, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Hassani Azad', 'Affiliation': 'Infectious and Tropical Diseases Research Center, Hormozgan Health Institute, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Haddad', 'Affiliation': 'Clinical Research Development Center, Shahid Mohammadi Hospital, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Arabi', 'Affiliation': 'Department of Internal Medicine and Public Health Research Center, Family Medicine Department, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Dariush', 'Initials': 'D', 'LastName': 'Hooshyar', 'Affiliation': 'Student Research Committee, Faculty of Medicine, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Mitra', 'Initials': 'M', 'LastName': 'KazemiJahromi', 'Affiliation': 'Endocrinology and Metabolism Research Center, Hormozgan University of Medical Sciences, Bandar Abbas, Iran. mitra.kazemijahromi@gmail.com.'}]",Trials,['10.1186/s13063-020-04773-6']
3345,33051340,Pembrolizumab with or without radiation therapy for metastatic non-small cell lung cancer: a randomized phase I/II trial.,"BACKGROUND


In this phase I/II trial, we evaluated the safety and effectiveness of pembrolizumab, with or without concurrent radiotherapy (RT), for lung and liver lesions from metastatic non-small cell lung cancer (mNSCLC).
METHODS


Patients with lung or liver lesions amenable to RT plus at least one additional non-contiguous lesion were included regardless of programmed death-ligand 1 (PD-L1) status. Pembrolizumab was given at 200 mg every 3 weeks for up to 32 cycles with or without concurrent RT. Metastatic lesions were treated with stereotactic body RT (SBRT; 50 Gy in 4 fractions) if clinically feasible or with traditionally fractionated RT (45 Gy in 15 fractions) if not. The primary end point was the best out-of-field lesion response, and a key secondary end point was progression-free survival (PFS).
RESULTS


The median follow-up time was 20.4 months. One hundred patients (20 phase I, 80 phase II) were evaluable for toxicity, and 72 phase II patients were evaluable for treatment response. No patients in the phase I group experienced grade 4-5 events; in the phase II group, two had grade 4 events and nine had grade 3 events. The ORR in the combined-modality cohort (irrespective of RT schema) was 22%, vs 25% in the pembrolizumab group (irrespective of receipt of salvage RT) (p=0.99). In the concurrent pembrolizumab+RT groups, the out-of-field ORRs were 38% in the pembrolizumab+SBRT group and 10% in the pembrolizumab+traditional RT group. When examining the pembrolizumab-alone patients, the out-of-field ORRs were 33% in those designated to receive salvage SBRT (if required) and 17% for salvage traditional RT. In all patients, the median PFS for pembrolizumab alone was 5.1 months (95% CI 3.4 to 12.7 months), and pembrolizumab/RT (regardless of schema) was 9.1 months (95% CI 3.6 to 18.4 months) (p=0.52). An exploratory analysis revealed that for patients with low PD-L1 expression, the median PFS was 4.6 vs 20.8 months for pembrolizumab with and without RT, respectively (p=0.004).
CONCLUSIONS


Concurrent immunoradiotherapy for mNSCLC is safe, although larger trials are required to address which patients benefit most from RT.
TRIAL REGISTRATION NUMBER


NCT02444741.",2020,"In all patients, the median PFS for pembrolizumab alone was 5.1 months (95% CI 3.4 to 12.7 months), and pembrolizumab/RT (regardless of schema) was 9.1 months (95% CI 3.6 to 18.4 months) (p=0.52).","['Metastatic lesions', 'metastatic non-small cell lung cancer', 'One hundred patients (20 phase', 'lung and liver lesions from metastatic non-small cell lung cancer (mNSCLC', 'Patients with lung or liver lesions amenable to RT plus at least one additional non-contiguous lesion were included regardless of programmed death-ligand 1 (PD-L1) status']","['stereotactic body RT (SBRT', 'Pembrolizumab with or without radiation therapy', 'pembrolizumab', 'pembrolizumab+RT', 'pembrolizumab+traditional RT', 'salvage RT', 'Pembrolizumab', 'pembrolizumab, with or without concurrent radiotherapy (RT', 'pembrolizumab+SBRT']","['best out-of-field lesion response', 'ORR', 'toxicity', 'grade 4-5 events', 'progression-free survival (PFS', 'median PFS']","[{'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0278987', 'cui_str': 'Metastatic non-small cell lung cancer'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0577053', 'cui_str': 'Lesion of liver'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205283', 'cui_str': 'Contiguous'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0449438', 'cui_str': 'Status'}]","[{'cui': 'C1720823', 'cui_str': 'Stereotactic Body Radiotherapy'}, {'cui': 'C0729296', 'cui_str': 'Stereotactic'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0085405', 'cui_str': 'Salvage therapy'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",,0.0540634,"In all patients, the median PFS for pembrolizumab alone was 5.1 months (95% CI 3.4 to 12.7 months), and pembrolizumab/RT (regardless of schema) was 9.1 months (95% CI 3.6 to 18.4 months) (p=0.52).","[{'ForeName': 'James', 'Initials': 'J', 'LastName': 'Welsh', 'Affiliation': 'Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas, United States JWelsh@mdanderson.org.'}, {'ForeName': 'Hari', 'Initials': 'H', 'LastName': 'Menon', 'Affiliation': 'Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas, United States.'}, {'ForeName': 'Dawei', 'Initials': 'D', 'LastName': 'Chen', 'Affiliation': 'Department of Radiation Oncology, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, China.'}, {'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Verma', 'Affiliation': 'Radiation Oncology, Allegheny General Hospital, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Chad', 'Initials': 'C', 'LastName': 'Tang', 'Affiliation': 'Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas, United States.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Altan', 'Affiliation': 'Thoracic/Head and Neck Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Hess', 'Affiliation': 'Department of Biostatistics, MD Anderson Cancer Center, Houston, United States.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'de Groot', 'Affiliation': 'Division of Diagnostic Imaging, Department of Diagnostic Radiology, The University of Texas M.D. Anderson Cancer Center, Houston, United States.'}, {'ForeName': 'Quynh-Nhu', 'Initials': 'QN', 'LastName': 'Nguyen', 'Affiliation': 'Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas, United States.'}, {'ForeName': 'Rejani', 'Initials': 'R', 'LastName': 'Varghese', 'Affiliation': 'Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas, United States.'}, {'ForeName': 'Nathan I', 'Initials': 'NI', 'LastName': 'Comeaux', 'Affiliation': 'Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas, United States.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Simon', 'Affiliation': 'Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas, United States.'}, {'ForeName': 'Ferdinandos', 'Initials': 'F', 'LastName': 'Skoulidis', 'Affiliation': 'Thoracic/Head and Neck Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Joe Y', 'Initials': 'JY', 'LastName': 'Chang', 'Affiliation': 'Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas, United States.'}, {'ForeName': 'Vasiliki', 'Initials': 'V', 'LastName': 'Papdimitrakopoulou', 'Affiliation': 'Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas, United States.'}, {'ForeName': 'Steven H', 'Initials': 'SH', 'LastName': 'Lin', 'Affiliation': 'Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas, United States.'}, {'ForeName': 'John V', 'Initials': 'JV', 'LastName': 'Heymach', 'Affiliation': 'Thoracic/Head and Neck Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}]",Journal for immunotherapy of cancer,['10.1136/jitc-2020-001001']
3346,33051342,"Novel, non-invasive imaging approach to identify patients with advanced non-small cell lung cancer at risk of hyperprogressive disease with immune checkpoint blockade.","PURPOSE


Hyperprogression is an atypical response pattern to immune checkpoint inhibition that has been described within non-small cell lung cancer (NSCLC). The paradoxical acceleration of tumor growth after immunotherapy has been associated with significantly shortened survival, and currently, there are no clinically validated biomarkers to identify patients at risk of hyperprogression.
EXPERIMENTAL DESIGN


A total of 109 patients with advanced NSCLC who underwent monotherapy with Programmed cell death protein-1 (PD1)/Programmed death-ligand-1 (PD-L1) inhibitors were included in the study. Using RECIST measurements, we divided the patients into responders (n=50) (complete/partial response or stable disease) and non-responders (n=59) (progressive disease). Tumor growth kinetics were used to further identify hyperprogressors (HPs, n=19) among non-responders. Patients were randomized into a training set (D 1 =30) and a test set (D 2 =79) with the essential caveat that HPs were evenly distributed among the two sets. A total of 198 radiomic textural patterns from within and around the target nodules and features relating to tortuosity of the nodule associated vasculature were extracted from the pretreatment CT scans.
RESULTS


The random forest classifier using the top features associated with hyperprogression was able to distinguish between HP and other radiographical response patterns with an area under receiver operating curve of 0.85±0.06 in the training set (D 1 =30) and 0.96 in the validation set (D 2 =79). These features included one peritumoral texture feature from 5 to 10 mm outside the tumor and two nodule vessel-related tortuosity features. Kaplan-Meier survival curves showed a clear stratification between classifier predicted HPs versus non-HPs for overall survival (D 2 : HR=2.66, 95% CI 1.27 to 5.55; p=0.009).
CONCLUSIONS


Our study suggests that image-based radiomics markers extracted from baseline CTs of advanced NSCLC treated with PD-1/PD-L1 inhibitors may help identify patients at risk of hyperprogressions.",2020,"Kaplan-Meier survival curves showed a clear stratification between classifier predicted HPs versus non-HPs for overall survival (D 2 : HR=2.66, 95% CI 1.27 to 5.55; p=0.009).
","['109 patients with advanced NSCLC who underwent monotherapy with Programmed cell death protein-1 (PD1)/Programmed death-ligand-1 (PD-L1) inhibitors were included in the study', 'patients with advanced non-small cell lung cancer at risk of hyperprogressive disease with immune checkpoint blockade', 'patients into responders (n=50) (complete/partial response or stable disease) and non-responders (n=59) (progressive disease']",['PD-1/PD-L1 inhibitors'],['overall survival'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0135710', 'cui_str': 'PDCD1 protein, human'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0023688', 'cui_str': 'Ligands'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C1155874', 'cui_str': 'Cell Cycle Checkpoints'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0023688', 'cui_str': 'Ligands'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",109.0,0.0755434,"Kaplan-Meier survival curves showed a clear stratification between classifier predicted HPs versus non-HPs for overall survival (D 2 : HR=2.66, 95% CI 1.27 to 5.55; p=0.009).
","[{'ForeName': 'Pranjal', 'Initials': 'P', 'LastName': 'Vaidya', 'Affiliation': 'Biomedical Engineering, Case Western Reserve University, Cleveland, Ohio, USA.'}, {'ForeName': 'Kaustav', 'Initials': 'K', 'LastName': 'Bera', 'Affiliation': 'Biomedical Engineering, Case Western Reserve University, Cleveland, Ohio, USA.'}, {'ForeName': 'Pradnya D', 'Initials': 'PD', 'LastName': 'Patil', 'Affiliation': 'Hematology and Medical Oncology, Cleveland Clinic, Cleveland, Ohio, USA.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Gupta', 'Affiliation': 'Department of Radiology, University Hospitals of Cleveland, Cleveland, Ohio, USA.'}, {'ForeName': 'Prantesh', 'Initials': 'P', 'LastName': 'Jain', 'Affiliation': 'Department of Radiology, University Hospitals of Cleveland, Cleveland, Ohio, USA.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Alilou', 'Affiliation': 'Biomedical Engineering, Case Western Reserve University, Cleveland, Ohio, USA.'}, {'ForeName': 'Mohammadhadi', 'Initials': 'M', 'LastName': 'Khorrami', 'Affiliation': 'Biomedical Engineering, Case Western Reserve University, Cleveland, Ohio, USA.'}, {'ForeName': 'Vamsidhar', 'Initials': 'V', 'LastName': 'Velcheti', 'Affiliation': 'Medical Oncology, NYU Langone Health, New York, New York, USA.'}, {'ForeName': 'Anant', 'Initials': 'A', 'LastName': 'Madabhushi', 'Affiliation': 'Biomedical Engineering, Case Western Reserve University, Cleveland, Ohio, USA axm788@case.edu.'}]",Journal for immunotherapy of cancer,['10.1136/jitc-2020-001343']
3347,33052125,The Impact of Visualization Format and Navigational Options on Laypeople's Perception and Preference of Surgery Information Videos: Randomized Controlled Trial and Online Survey.,"BACKGROUND


Patients need to be educated about possible treatment choices in order to make informed medical decisions. As most patients are medical laypeople, they find it difficult to understand complex medical information sufficiently to feel confident about a decision. Multimedia interventions such as videos are increasingly used to supplement personal consultations with medical professionals. Former research has shown that such interventions may have a positive effect on understanding, decision making, and emotional reactions. However, it is thus far unclear how different features of videos influence these outcomes.
OBJECTIVE


We aimed to examine the impact of visualization formats and basic navigational options in medical information videos about cruciate ligament surgery on recipients' knowledge gain, emotions, attitude, and hypothetical decision-making ability.
METHODS


In a between-group randomized experiment (Study 1), 151 participants watched 1 of 4 videos (schematic vs realistic visualization; available vs unavailable navigational options). In a separate online survey (Study 2), 110 participants indicated their preference for a video design. All participants were medical laypeople without personal experience with a cruciate ligament rupture and were presented with a fictional decision situation.
RESULTS


In Study 1, participants who used navigational options (n=36) gained significantly more factual knowledge (P=.005) and procedural knowledge (P<.001) than participants who did not have or use navigational options (n=115). A realistic visualization induced more fear (P=.001) and disgust (P<.001) than a schematic video. Attitude toward the surgery (P=.02) and certainty regarding the decision for or against surgery (P<.001) were significantly more positive after watching the video than before watching the video. Participants who watched a schematic video rated the video significantly higher than that by participants who watched a realistic video (P<.001). There were no significant group differences with regard to hypothetical decision making and attitude toward the intervention. In addition, we did not identify any influence of the visualization format on knowledge acquisition. In Study 2, 58 of 110 participants (52.7%) indicated that they would prefer a schematic visualization, 26 (23.6%) preferred a realistic visualization, 17 (15.5%) wanted either visualization, and 9 (8.2%) did not want to watch a video at all. Of the participants who wanted to watch a video, 91 (90.1%) preferred to have navigational options, 3 (3.0%) preferred not to have navigational options, and 7 (6.9%) did not mind the options.
CONCLUSION


Our study indicates that the perception of medical information videos is influenced by their design. Schematic videos with navigational options are the most helpful among all videos to avoid negative emotions and support knowledge acquisition when informing patients about an intervention. The visualization format and navigational options are important features that should be considered when designing medical videos for patient education.
TRIAL REGISTRATION


Deutsches Register Klinischer Studien DRKS00016003; https://www.drks.de/drks_web/ navigate.do?navigationId= trial.HTML&TRIAL_ID=DRKS00016003 (Archived by WebCite at http://www.webcitation.org/746ASSAhN).",2018,A realistic visualization induced more fear (P=.001) and disgust (P<.001) than a schematic video.,"[""Laypeople's Perception and Preference of Surgery Information Videos"", 'participants who used navigational options (n=36) gained significantly more factual knowledge (P=.005) and procedural knowledge (P<.001) than participants who did not have or use navigational options (n=115', 'participants who wanted to watch a video, 91 (90.1%) preferred to have navigational options, 3 (3.0%) preferred not to have navigational options, and 7 (6.9%) did not mind the options', '151 participants watched 1 of 4', 'All participants were medical laypeople without personal experience with a cruciate ligament rupture and were presented with a fictional decision situation', '110 participants indicated their preference for a video design']","['cruciate ligament surgery', 'videos (schematic vs realistic visualization; available vs unavailable navigational options', 'Visualization Format and Navigational Options']",[],"[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C1444647', 'cui_str': 'Wanted'}, {'cui': 'C4517826', 'cui_str': '6.9'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0263791', 'cui_str': 'Rupture of cruciate ligaments'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}]","[{'cui': 'C0023685', 'cui_str': 'Structure of ligament'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0686905', 'cui_str': 'Unavailability'}, {'cui': 'C1301627', 'cui_str': 'Format'}]",[],151.0,0.0675548,A realistic visualization induced more fear (P=.001) and disgust (P<.001) than a schematic video.,"[{'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Eggeling', 'Affiliation': 'Knowledge Construction Lab, Leibniz-Institut fuer Wissensmedien, Tuebingen, Germany.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Bientzle', 'Affiliation': 'Knowledge Construction Lab, Leibniz-Institut fuer Wissensmedien, Tuebingen, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Shiozawa', 'Affiliation': 'Institute of Clinical Anatomy and Cell Analysis, Eberhard Karls University Tuebingen, Tuebingen, Germany.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Cress', 'Affiliation': 'Knowledge Construction Lab, Leibniz-Institut fuer Wissensmedien, Tuebingen, Germany.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Kimmerle', 'Affiliation': 'Knowledge Construction Lab, Leibniz-Institut fuer Wissensmedien, Tuebingen, Germany.'}]",Journal of participatory medicine,['10.2196/12338']
3348,33052539,Inhaler Technique and Self-reported Adherence to Medications Among Hospitalised People with Asthma and COPD.,"BACKGROUND


Metered dose inhalers (MDIs) and dry powder inhalers (DPIs) are devices used for the treatment of asthma and chronic obstructive pulmonary disease (COPD). Inhaler technique is important since incorrect technique can lead to a poorer prognosis and hospitalization.
OBJECTIVE


The objective of this study was to investigate the inhaler technique and overall adherence to medications in an adult population with asthma and COPD.
PATIENTS AND METHODS


Those invited to participate were people admitted to Umeå University Hospital in northern Sweden in October, November and December 2018, with inhaled medication prescribed prior to admission. Inhaler technique was assessed using checklists and observations with placebo-inhalers were conducted. The Medication Adherence Report Scale (MARS)-5 was used to measure self-reported overall adherence to drug medication.
RESULTS


Of the 23 people included in the study, 26.1% had one or more critical errors in inhaler technique and 30.4% were considered overall non-adherent to drug medication. Among the 23 participants, the mean age, and the number of regularly prescribed medications were higher among those with poor inhaler technique than among people with no error in their inhaler technique.
CONCLUSION


This study indicates that poor inhaler technique and overall non-adherence to medications occur among hospitalised people with asthma and COPD living in northern Sweden. Interventions to improve inhaler technique and adherence to drugs are needed.",2020,"Among the 23 participants, the mean age, and the number of regularly prescribed medications were higher among those with poor inhaler technique than among people with no error in their inhaler technique.
","['asthma and chronic obstructive pulmonary disease (COPD', 'hospitalised people with asthma and COPD living in northern Sweden', 'adult population with asthma and COPD', 'Hospitalised People with Asthma and COPD', 'Those invited to participate were people admitted to Umeå University Hospital in northern Sweden in October, November and December 2018, with inhaled medication prescribed prior to admission']",[],[],"[{'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0332152', 'cui_str': 'Before'}]",[],[],,0.0436148,"Among the 23 participants, the mean age, and the number of regularly prescribed medications were higher among those with poor inhaler technique than among people with no error in their inhaler technique.
","[{'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Elander', 'Affiliation': 'Department of Integrative Medical Biology, Umeå University, 90187, Umeå, Sweden.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Gustafsson', 'Affiliation': 'Department of Integrative Medical Biology, Umeå University, 90187, Umeå, Sweden. maria.gustafsson@umu.se.'}]",Drugs - real world outcomes,['10.1007/s40801-020-00210-x']
3349,33048923,Evaluation of a pharmacist-led actionable audit and feedback intervention for improving medication safety in UK primary care: An interrupted time series analysis.,"BACKGROUND


We evaluated the impact of the pharmacist-led Safety Medication dASHboard (SMASH) intervention on medication safety in primary care.
METHODS AND FINDINGS


SMASH comprised (1) training of clinical pharmacists to deliver the intervention; (2) a web-based dashboard providing actionable, patient-level feedback; and (3) pharmacists reviewing individual at-risk patients, and initiating remedial actions or advising general practitioners on doing so. It was implemented in 43 general practices covering a population of 235,595 people in Salford (Greater Manchester), UK. All practices started receiving the intervention between 18 April 2016 and 26 September 2017. We used an interrupted time series analysis of rates (prevalence) of potentially hazardous prescribing and inadequate blood-test monitoring, comparing observed rates post-intervention to extrapolations from a 24-month pre-intervention trend. The number of people registered to participating practices and having 1 or more risk factors for being exposed to hazardous prescribing or inadequate blood-test monitoring at the start of the intervention was 47,413 (males: 23,073 [48.7%]; mean age: 60 years [standard deviation: 21]). At baseline, 95% of practices had rates of potentially hazardous prescribing (composite of 10 indicators) between 0.88% and 6.19%. The prevalence of potentially hazardous prescribing reduced by 27.9% (95% CI 20.3% to 36.8%, p < 0.001) at 24 weeks and by 40.7% (95% CI 29.1% to 54.2%, p < 0.001) at 12 months after introduction of SMASH. The rate of inadequate blood-test monitoring (composite of 2 indicators) reduced by 22.0% (95% CI 0.2% to 50.7%, p = 0.046) at 24 weeks; the change at 12 months (23.5%) was no longer significant (95% CI -4.5% to 61.6%, p = 0.127). After 12 months, 95% of practices had rates of potentially hazardous prescribing between 0.74% and 3.02%. Study limitations include the fact that practices were not randomised, and therefore unmeasured confounding may have influenced our findings.
CONCLUSIONS


The SMASH intervention was associated with reduced rates of potentially hazardous prescribing and inadequate blood-test monitoring in general practices. This reduction was sustained over 12 months after the start of the intervention for prescribing but not for monitoring of medication. There was a marked reduction in the variation in rates of hazardous prescribing between practices.",2020,"After 12 months, 95% of practices had rates of potentially hazardous prescribing between 0.74% and 3.02%.","['47,413 (males: 23,073 [48.7%]; mean age: 60 years [standard deviation: 21', '43 general practices covering a population of 235,595 people in Salford (Greater Manchester), UK', 'UK primary care']","['pharmacist-led actionable audit and feedback intervention', 'clinical pharmacists to deliver the intervention; (2) a web-based dashboard providing actionable, patient-level feedback; and (3) pharmacists reviewing individual at-risk patients, and initiating remedial actions or advising general practitioners on doing so', 'pharmacist-led Safety Medication dASHboard (SMASH) intervention']","['rate of inadequate blood-test monitoring (composite of 2 indicators', 'reduced rates of potentially hazardous prescribing and inadequate blood-test monitoring', 'prevalence of potentially hazardous prescribing', 'rates of potentially hazardous prescribing']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0454856', 'cui_str': 'Greater Manchester'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1449564', 'cui_str': 'Clinical pharmacist'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C1828381', 'cui_str': 'Recommendation - action'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0018941', 'cui_str': 'Blood test'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}]",235595.0,0.163888,"After 12 months, 95% of practices had rates of potentially hazardous prescribing between 0.74% and 3.02%.","[{'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Peek', 'Affiliation': 'NIHR Greater Manchester Patient Safety Translational Research Centre, University of Manchester, Manchester Academic Health Science Centre, Manchester, United Kingdom.'}, {'ForeName': 'Wouter T', 'Initials': 'WT', 'LastName': 'Gude', 'Affiliation': 'Department of Medical Informatics, Amsterdam UMC, Amsterdam Public Health Research Institute, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Richard N', 'Initials': 'RN', 'LastName': 'Keers', 'Affiliation': 'NIHR Greater Manchester Patient Safety Translational Research Centre, University of Manchester, Manchester Academic Health Science Centre, Manchester, United Kingdom.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Williams', 'Affiliation': 'NIHR Greater Manchester Patient Safety Translational Research Centre, University of Manchester, Manchester Academic Health Science Centre, Manchester, United Kingdom.'}, {'ForeName': 'Evangelos', 'Initials': 'E', 'LastName': 'Kontopantelis', 'Affiliation': 'NIHR School for Primary Care Research, University of Manchester, Manchester Academic Health Science Centre, Manchester, United Kingdom.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Jeffries', 'Affiliation': 'NIHR Greater Manchester Patient Safety Translational Research Centre, University of Manchester, Manchester Academic Health Science Centre, Manchester, United Kingdom.'}, {'ForeName': 'Denham L', 'Initials': 'DL', 'LastName': 'Phipps', 'Affiliation': 'NIHR Greater Manchester Patient Safety Translational Research Centre, University of Manchester, Manchester Academic Health Science Centre, Manchester, United Kingdom.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Brown', 'Affiliation': 'NIHR Greater Manchester Patient Safety Translational Research Centre, University of Manchester, Manchester Academic Health Science Centre, Manchester, United Kingdom.'}, {'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'Avery', 'Affiliation': 'NIHR Greater Manchester Patient Safety Translational Research Centre, University of Manchester, Manchester Academic Health Science Centre, Manchester, United Kingdom.'}, {'ForeName': 'Darren M', 'Initials': 'DM', 'LastName': 'Ashcroft', 'Affiliation': 'NIHR Greater Manchester Patient Safety Translational Research Centre, University of Manchester, Manchester Academic Health Science Centre, Manchester, United Kingdom.'}]",PLoS medicine,['10.1371/journal.pmed.1003286']
3350,33048964,Facemask against viral respiratory infections among Hajj pilgrims: A challenging cluster-randomized trial.,"BACKGROUND


In this large-scale cluster-randomized controlled trial (cRCT) we sought to assess the effectiveness of facemasks against viral respiratory infections.
METHODS AND RESULTS


Over three consecutive Hajj seasons (2013, 2014, 2015) pilgrims' tents in Makkah were allocated to 'facemask' or 'no facemask' group. Fifty facemasks were offered to participants in intervention tents, to be worn over four days, and none were offered to participants in control tents. All participants recorded facemask use and respiratory symptoms in health diaries. Nasal swabs were collected from the symptomatic for virus detection by reverse transcription polymerase chain reaction. Clinical symptoms and laboratory results were analyzed by 'intention- to-treat' and 'per-protocol'. A total of 7687 adult participants from 318 tents were randomized: 3864 from 149 tents to the intervention group, and 3823 from 169 tents to the control group. Participants were aged 18 to 95 (median 34, mean 37) years, with a male to female ratio of 1:1.2. Overall, respiratory viruses were detected in 277 of 650 (43%) nasal/pharyngeal swabs collected from symptomatic pilgrims. Common viruses were rhinovirus (35.1%), influenza (4.5%) and parainfluenza (1.7%). In the intervention arm, respectively 954 (24.7%) and 1842 (47.7%) participants used facemasks daily and intermittently, while in the control arm, respectively 546 (14.3%) and 1334 (34.9%) used facemasks daily and intermittently. By intention-to-treat analysis, facemask use did not seem to be effective against laboratory-confirmed viral respiratory infections (odds ratio [OR], 1.4; 95% confidence interval [CI], 0.9 to 2.1, p = 0.18) nor against clinical respiratory infection (OR, 1.1; 95% CI, 0.9 to 1.4, p = 0.40). Similarly, in a per-protocol analysis, facemask use did not seem to be effective against laboratory-confirmed viral respiratory infections (OR 1.2, 95% CI 0.9-1.7, p = 0.26) nor against clinical respiratory infection (OR 1.3, 95% CI 1.0-1.8, p = 0.06).
CONCLUSION


This trial was unable to provide conclusive evidence on facemask efficacy against viral respiratory infections most likely due to poor adherence to protocol.",2020,"By intention-to-treat analysis, facemask use did not seem to be effective against laboratory-confirmed viral respiratory infections (odds ratio [OR], 1.4; 95% confidence interval [CI], 0.9 to 2.1, p = 0.18) nor against clinical respiratory infection (OR, 1.1; 95% CI, 0.9 to 1.4, p = 0.40).","['Hajj pilgrims', 'Participants were aged 18 to 95 (median 34, mean 37) years, with a male to female ratio of 1:1.2', '7687 adult participants from 318 tents were randomized: 3864 from 149 tents to the intervention group, and 3823 from 169 tents to the control group']","[""facemask' or 'no facemask' group"", 'Facemask']","['clinical respiratory infection', 'facemask use and respiratory symptoms in health diaries', 'Overall, respiratory viruses', 'effective against laboratory-confirmed viral respiratory infections']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0677506', 'cui_str': 'Tent'}, {'cui': 'C5191071', 'cui_str': '149'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0035243', 'cui_str': 'Respiratory tract infection'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0037090', 'cui_str': 'Respiratory symptom'}, {'cui': 'C0018700', 'cui_str': 'Health Diaries'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0597404', 'cui_str': 'Respiratory viruses'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0729531', 'cui_str': 'Viral respiratory infection'}]",7687.0,0.198261,"By intention-to-treat analysis, facemask use did not seem to be effective against laboratory-confirmed viral respiratory infections (odds ratio [OR], 1.4; 95% confidence interval [CI], 0.9 to 2.1, p = 0.18) nor against clinical respiratory infection (OR, 1.1; 95% CI, 0.9 to 1.4, p = 0.40).","[{'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Alfelali', 'Affiliation': ""National Centre for Immunisation Research and Surveillance, The Children's Hospital at Westmead and The University of Sydney, Sydney, New South Wales, Australia.""}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Haworth', 'Affiliation': 'Menzies Institute for Medical Research Tasmania, Hobart, Tasmania, Australia.'}, {'ForeName': 'Osamah', 'Initials': 'O', 'LastName': 'Barasheed', 'Affiliation': ""National Centre for Immunisation Research and Surveillance, The Children's Hospital at Westmead and The University of Sydney, Sydney, New South Wales, Australia.""}, {'ForeName': 'Al-Mamoon', 'Initials': 'AM', 'LastName': 'Badahdah', 'Affiliation': ""National Centre for Immunisation Research and Surveillance, The Children's Hospital at Westmead and The University of Sydney, Sydney, New South Wales, Australia.""}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Bokhary', 'Affiliation': 'Marie Bashir Institute for Infectious Diseases and Biosecurity, School of Life & Environmental Sciences and School of Medical Sciences, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Tashani', 'Affiliation': ""Discipline of Child and Adolescent Health, The Children's Hospital at Westmead Clinical School, Sydney Medical School, The University of Sydney, Sydney, New South Wales, Australia.""}, {'ForeName': 'Mohammad I', 'Initials': 'MI', 'LastName': 'Azeem', 'Affiliation': ""National Centre for Immunisation Research and Surveillance, The Children's Hospital at Westmead and The University of Sydney, Sydney, New South Wales, Australia.""}, {'ForeName': 'Jen', 'Initials': 'J', 'LastName': 'Kok', 'Affiliation': 'Marie Bashir Institute for Infectious Diseases and Biosecurity, School of Life & Environmental Sciences and School of Medical Sciences, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Janette', 'Initials': 'J', 'LastName': 'Taylor', 'Affiliation': 'NSW Health Pathology - Institute for Clinical Pathology and Medical Research, Westmead Hospital and The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Elizabeth H', 'Initials': 'EH', 'LastName': 'Barnes', 'Affiliation': 'NHMRC Clinical Trials Centre, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Haitham', 'Initials': 'H', 'LastName': 'El Bashir', 'Affiliation': 'Rehabilitation Department, Al Jalila Children Specialty Hospital, Dubai, United Arab Emirates.'}, {'ForeName': 'Gulam', 'Initials': 'G', 'LastName': 'Khandaker', 'Affiliation': ""Discipline of Child and Adolescent Health, The Children's Hospital at Westmead Clinical School, Sydney Medical School, The University of Sydney, Sydney, New South Wales, Australia.""}, {'ForeName': 'Edward C', 'Initials': 'EC', 'LastName': 'Holmes', 'Affiliation': 'Marie Bashir Institute for Infectious Diseases and Biosecurity, School of Life & Environmental Sciences and School of Medical Sciences, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Dominic E', 'Initials': 'DE', 'LastName': 'Dwyer', 'Affiliation': 'Marie Bashir Institute for Infectious Diseases and Biosecurity, School of Life & Environmental Sciences and School of Medical Sciences, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Leon G', 'Initials': 'LG', 'LastName': 'Heron', 'Affiliation': ""National Centre for Immunisation Research and Surveillance, The Children's Hospital at Westmead and The University of Sydney, Sydney, New South Wales, Australia.""}, {'ForeName': 'Godwin J', 'Initials': 'GJ', 'LastName': 'Wilson', 'Affiliation': 'Department of Laboratory Medicine, Hamad Medical Corporation, Doha, Qatar.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Booy', 'Affiliation': ""National Centre for Immunisation Research and Surveillance, The Children's Hospital at Westmead and The University of Sydney, Sydney, New South Wales, Australia.""}, {'ForeName': 'Harunor', 'Initials': 'H', 'LastName': 'Rashid', 'Affiliation': ""National Centre for Immunisation Research and Surveillance, The Children's Hospital at Westmead and The University of Sydney, Sydney, New South Wales, Australia.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",PloS one,['10.1371/journal.pone.0240287']
3351,33048991,"Correction: High intensity, circuit-type integrated neuromuscular training alters energy balance and reduces body mass and fat in obese women: A 10-month training-detraining randomized controlled trial.",[This corrects the article DOI: 10.1371/journal.pone.0202390.].,2020,[This corrects the article DOI: 10.1371/journal.pone.0202390.].,['obese women'],['circuit-type integrated neuromuscular training alters energy balance'],[],"[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}]",[],,0.0641754,[This corrects the article DOI: 10.1371/journal.pone.0202390.].,"[{'ForeName': 'Alexios', 'Initials': 'A', 'LastName': 'Batrakoulis', 'Affiliation': ''}, {'ForeName': 'Athanasios Z', 'Initials': 'AZ', 'LastName': 'Jamurtas', 'Affiliation': ''}, {'ForeName': 'Kalliopi', 'Initials': 'K', 'LastName': 'Georgakouli', 'Affiliation': ''}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Draganidis', 'Affiliation': ''}, {'ForeName': 'Chariklia K', 'Initials': 'CK', 'LastName': 'Deli', 'Affiliation': ''}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Papanikolaou', 'Affiliation': ''}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Avloniti', 'Affiliation': ''}, {'ForeName': 'Athanasios', 'Initials': 'A', 'LastName': 'Chatzinikolaou', 'Affiliation': ''}, {'ForeName': 'Diamanda', 'Initials': 'D', 'LastName': 'Leontsini', 'Affiliation': ''}, {'ForeName': 'Panagiotis', 'Initials': 'P', 'LastName': 'Tsimeas', 'Affiliation': ''}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Comoutos', 'Affiliation': ''}, {'ForeName': 'Vassilios', 'Initials': 'V', 'LastName': 'Bouglas', 'Affiliation': ''}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Michalopoulou', 'Affiliation': ''}, {'ForeName': 'Ioannis G', 'Initials': 'IG', 'LastName': 'Fatouros', 'Affiliation': ''}]",PloS one,['10.1371/journal.pone.0240945']
3352,33057696,Effect of Integrating Machine Learning Mortality Estimates With Behavioral Nudges to Clinicians on Serious Illness Conversations Among Patients With Cancer: A Stepped-Wedge Cluster Randomized Clinical Trial.,"Importance


Serious illness conversations (SICs) are structured conversations between clinicians and patients about prognosis, treatment goals, and end-of-life preferences. Interventions that increase the rate of SICs between oncology clinicians and patients may improve goal-concordant care and patient outcomes.
Objective


To determine the effect of a clinician-directed intervention integrating machine learning mortality predictions with behavioral nudges on motivating clinician-patient SICs.
Design, Setting, and Participants


This stepped-wedge cluster randomized clinical trial was conducted across 20 weeks (from June 17 to November 1, 2019) at 9 medical oncology clinics (8 subspecialty oncology and 1 general oncology clinics) within a large academic health system in Pennsylvania. Clinicians at the 2 smallest subspecialty clinics were grouped together, resulting in 8 clinic groups randomly assigned to the 4 intervention wedge periods. Included participants in the intention-to-treat analyses were 78 oncology clinicians who received SIC training and their patients (N = 14 607) who had an outpatient oncology encounter during the study period.
Interventions


(1) Weekly emails to oncology clinicians with SIC performance feedback and peer comparisons; (2) a list of up to 6 high-risk patients (≥10% predicted risk of 180-day mortality) scheduled for the next week, estimated using a validated machine learning algorithm; and (3) opt-out text message prompts to clinicians on the patient's appointment day to consider an SIC. Clinicians in the control group received usual care consisting of weekly emails with cumulative SIC performance.
Main Outcomes and Measures


Percentage of patient encounters with an SIC in the intervention group vs the usual care (control) group.
Results


The sample consisted of 78 clinicians and 14 607 patients. The mean (SD) age of patients was 61.9 (14.2) years, 53.7% were female, and 70.4% were White. For all encounters, SICs were conducted among 1.3% in the control group and 4.6% in the intervention group, a significant difference (adjusted difference in percentage points, 3.3; 95% CI, 2.3-4.5; P < .001). Among 4124 high-risk patient encounters, SICs were conducted among 3.6% in the control group and 15.2% in the intervention group, a significant difference (adjusted difference in percentage points, 11.6; 95% CI, 8.2-12.5; P < .001).
Conclusions and Relevance


In this stepped-wedge cluster randomized clinical trial, an intervention that delivered machine learning mortality predictions with behavioral nudges to oncology clinicians significantly increased the rate of SICs among all patients and among patients with high mortality risk who were targeted by the intervention. Behavioral nudges combined with machine learning mortality predictions can positively influence clinician behavior and may be applied more broadly to improve care near the end of life.
Trial Registration


ClinicalTrials.gov Identifier: NCT03984773.",2020,"Among 4124 high-risk patient encounters, SICs were conducted among 3.6% in the control group and 15.2% in the intervention group, a significant difference (adjusted difference in percentage points, 11.6; 95% CI, 8.2-12.5; P < .001).
","['Patients With Cancer', '20 weeks (from June 17 to November 1, 2019) at 9 medical oncology clinics (8 subspecialty oncology and 1 general oncology clinics) within a large academic health system in Pennsylvania', 'patients with high mortality risk who were targeted by the intervention', '78 clinicians and 14\u202f607 patients', 'Included participants in the intention-to-treat analyses were 78 oncology clinicians who received SIC training and their patients (N\u2009=\u200914\u202f607) who had an outpatient oncology encounter during the study period', 'The mean (SD) age of patients was 61.9 (14.2) years, 53.7% were female, and 70.4% were White', 'Clinicians at the 2 smallest subspecialty clinics']","['Integrating Machine Learning Mortality Estimates', ""validated machine learning algorithm; and (3) opt-out text message prompts to clinicians on the patient's appointment day to consider an SIC"", 'usual care consisting of weekly emails with cumulative SIC performance']",['rate of SICs'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0025098', 'cui_str': 'Medical oncology'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C3839015', 'cui_str': 'Oncology clinic'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0030853', 'cui_str': 'Pennsylvania'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0347984', 'cui_str': 'During'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}]","[{'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0030675', 'cui_str': 'Patient Appointments'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0013849', 'cui_str': 'Email'}]",[],78.0,0.119541,"Among 4124 high-risk patient encounters, SICs were conducted among 3.6% in the control group and 15.2% in the intervention group, a significant difference (adjusted difference in percentage points, 11.6; 95% CI, 8.2-12.5; P < .001).
","[{'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Manz', 'Affiliation': 'Department of Population Sciences, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Ravi B', 'Initials': 'RB', 'LastName': 'Parikh', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Dylan S', 'Initials': 'DS', 'LastName': 'Small', 'Affiliation': 'Wharton School of the University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Chalanda N', 'Initials': 'CN', 'LastName': 'Evans', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Corey', 'Initials': 'C', 'LastName': 'Chivers', 'Affiliation': 'University of Pennsylvania Health System, Philadelphia.'}, {'ForeName': 'Susan H', 'Initials': 'SH', 'LastName': 'Regli', 'Affiliation': 'University of Pennsylvania Health System, Philadelphia.'}, {'ForeName': 'C William', 'Initials': 'CW', 'LastName': 'Hanson', 'Affiliation': 'University of Pennsylvania Health System, Philadelphia.'}, {'ForeName': 'Justin E', 'Initials': 'JE', 'LastName': 'Bekelman', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Charles A L', 'Initials': 'CAL', 'LastName': 'Rareshide', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': ""O'Connor"", 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Lynn M', 'Initials': 'LM', 'LastName': 'Schuchter', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Lawrence N', 'Initials': 'LN', 'LastName': 'Shulman', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Mitesh S', 'Initials': 'MS', 'LastName': 'Patel', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}]",JAMA oncology,['10.1001/jamaoncol.2020.4759']
3353,33059607,A novel Vi-diphtheria toxoid typhoid conjugate vaccine is safe and can induce immunogenicity in healthy Indonesian children 2-11 years: a phase II preliminary report.,"BACKGROUND


Typhoid fever caused by Salmonella enteric serovar Typhi (S. Typhi) is a common cause of morbidity in the world. In 2017, 14.3 million cases of Typhoid and paratyphoid fever occurred globally. School age children between 3 to 19 years old are the most affected. Poor sanitation and multi drug resistance have increased the need for vaccines to reduce the global burden of disease. Based on previous trials, typhoid conjugate vaccines have longer- lasting protection, higher efficacy, require fewer doses and are suitable from infancy that allows them to be incorporated into the routine immunization program. Our previous phase I trial proved that a novel Vi-DT typhoid conjugate vaccine is safe and immunogenic in subjects 2-5 and 18-40 years. Our phase II trial consisted of subjects 6 months to 40 years. Our previously published paper on subjects 6 to < 24 months proved that this vaccine is safe and immunogenic for this age group. Therefore, with this paper we aimed to evaluate the safety and immunogenicity in children 2-11 years.
METHODS


A randomized, observer-blind, superiority design of Vi-DT Typhoid conjugate vaccine compared to Vi-polysaccharide vaccine (Vi-PS) phase II study was conducted from October 2018 to December 2018 where 200 subjects aged 2-11 years were recruited. A blood sample prior to vaccination was taken, followed by administration of a single dose of either test vaccine (Vi-DT) or control vaccine (Vi-PS) and then a second blood sample was collected 28 days post vaccination. Adverse reactions were assessed and antibody increment was evaluated at 28 days post vaccination through collected serum sample.
RESULTS


Pain was the most common local reaction. Fever and muscle pain were the most common systemic reactions. Both Vi-DT and Vi-PS groups had roughly the same number of adverse reactions. At 28 days post vaccination, 100% of subjects in the Vi-DT group and 93% of subjects in the Vi-PS group produced antibody increment ≥4 times. The Vi-DT group produced a higher GMT as compared to Vi-PS.
CONCLUSION


Vi-DT vaccine is safe and immunogenic in children 2-11 years old.
TRIAL REGISTRATION


Trial registration number: NCT03460405 .",2020,I trial proved that a novel Vi-DT typhoid conjugate vaccine is safe and immunogenic in subjects 2-5 and 18-40 years.,"['children 2-11\u2009years old', 'subjects 2-5 and 18-40\u2009years', 'October 2018 to December 2018 where 200 subjects aged 2-11\u2009years were recruited', 'children 2-11\u2009years', 'healthy Indonesian children 2-11\u2009years', 'School age children between 3 to 19\u2009years old are the most affected']","['Vi-DT Typhoid conjugate vaccine', 'Vi-DT vaccine', 'vaccine (Vi-DT) or control vaccine (Vi-PS', 'diphtheria toxoid typhoid conjugate vaccine', 'Vi-polysaccharide vaccine (Vi-PS', 'novel Vi-DT typhoid conjugate vaccine']","['Fever and muscle pain', 'adverse reactions', 'safety and immunogenicity', 'Adverse reactions']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0021248', 'cui_str': 'Indonesian language'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0392760', 'cui_str': 'Affecting'}]","[{'cui': 'C0041466', 'cui_str': 'Typhoid fever'}, {'cui': 'C0206515', 'cui_str': 'Vaccines, Conjugate'}, {'cui': 'C0058773', 'cui_str': 'Diphtheria + tetanus vaccine'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0012551', 'cui_str': 'diphtheria toxoid vaccine, inactivated'}, {'cui': 'C0032594', 'cui_str': 'Polysaccharide'}, {'cui': 'C0205314', 'cui_str': 'New'}]","[{'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.335723,I trial proved that a novel Vi-DT typhoid conjugate vaccine is safe and immunogenic in subjects 2-5 and 18-40 years.,"[{'ForeName': 'Bernie Endyarni', 'Initials': 'BE', 'LastName': 'Medise', 'Affiliation': 'Department of Child Health, Faculty of Medicine Universitas Indonesia, Dr. Cipto Mangunkusumo General National Hospital, Jalan Diponegoro no, Jakarta, 71, Indonesia. bernie.medise@yahoo.com.'}, {'ForeName': 'Soedjatmiko', 'Initials': 'S', 'LastName': 'Soedjatmiko', 'Affiliation': 'Department of Child Health, Faculty of Medicine Universitas Indonesia, Dr. Cipto Mangunkusumo General National Hospital, Jalan Diponegoro no, Jakarta, 71, Indonesia.'}, {'ForeName': 'Hartono', 'Initials': 'H', 'LastName': 'Gunardi', 'Affiliation': 'Department of Child Health, Faculty of Medicine Universitas Indonesia, Dr. Cipto Mangunkusumo General National Hospital, Jalan Diponegoro no, Jakarta, 71, Indonesia.'}, {'ForeName': 'Rini', 'Initials': 'R', 'LastName': 'Sekartini', 'Affiliation': 'Department of Child Health, Faculty of Medicine Universitas Indonesia, Dr. Cipto Mangunkusumo General National Hospital, Jalan Diponegoro no, Jakarta, 71, Indonesia.'}, {'ForeName': 'Hindra Irawan', 'Initials': 'HI', 'LastName': 'Satari', 'Affiliation': 'Department of Child Health, Faculty of Medicine Universitas Indonesia, Dr. Cipto Mangunkusumo General National Hospital, Jalan Diponegoro no, Jakarta, 71, Indonesia.'}, {'ForeName': 'Sri Rezeki', 'Initials': 'SR', 'LastName': 'Hadinegoro', 'Affiliation': 'Department of Child Health, Faculty of Medicine Universitas Indonesia, Dr. Cipto Mangunkusumo General National Hospital, Jalan Diponegoro no, Jakarta, 71, Indonesia.'}, {'ForeName': 'Angga', 'Initials': 'A', 'LastName': 'Wirahmadi', 'Affiliation': 'Department of Child Health, Faculty of Medicine Universitas Indonesia, Dr. Cipto Mangunkusumo General National Hospital, Jalan Diponegoro no, Jakarta, 71, Indonesia.'}, {'ForeName': 'Mita', 'Initials': 'M', 'LastName': 'Puspita', 'Affiliation': 'PT. Bio Farma, Bandung, Indonesia.'}, {'ForeName': 'Rini Mulia', 'Initials': 'RM', 'LastName': 'Sari', 'Affiliation': 'PT. Bio Farma, Bandung, Indonesia.'}, {'ForeName': 'Jae Seung', 'Initials': 'JS', 'LastName': 'Yang', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Arijit', 'Initials': 'A', 'LastName': 'Sil', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Sushant', 'Initials': 'S', 'LastName': 'Sahastrabuddhe', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Novilia Sjafri', 'Initials': 'NS', 'LastName': 'Bachtiar', 'Affiliation': 'PT. Bio Farma, Bandung, Indonesia.'}]",BMC pediatrics,['10.1186/s12887-020-02375-4']
3354,33059610,The MAKS-s study: multicomponent non-pharmacological intervention for people with severe dementia in inpatient care - study protocol of a randomised controlled trial.,"BACKGROUND


Nursing homes accommodate a large number of people with severe dementia. More than 80% of residents with dementia suffer from behavioural and psychological symptoms, that can have consequences on the perceived burden of the formal caregivers. Internationally, the number of studies on non-pharmacological interventions for people with severe dementia is very small. One way to reduce these symptoms is to meet the needs of people with severe dementia. The non-pharmacological group intervention MAKS-s, which we will investigate in this study, is intended to reduce the behavioural and psychological symptoms and to improve the quality of life of such people. Additionally, we will investigate the effects on the burden carried by formal caregivers.
METHODS


With the present study, we will investigate the effectiveness of a multicomponent non-pharmacological intervention for people with severe dementia living in nursing homes (primary target group). A power analysis indicated that 144 dementia participants should initially be included. In addition, a secondary target group (nursing home staff) will be examined with respect to their dementia-related stress experiences. The study will be conducted as a cluster randomised controlled trail in Germany with a 6-month intervention phase. The nursing homes in the waitlist control group will provide ""care as usual."" The primary endpoints of the study will be the behavioural and psychological symptoms of dementia and the quality of life of people with severe dementia. The total duration of the study will be 18 months. Data will be collected by using observer rating scales.
DISCUSSION


The project has some outstanding quality features. The external validity is high, because it is situated in a naturalistic setting in nursing homes and is being carried out with available nursing employees. Due to this fact, a permanent implementation also seems to be possible. Since the participating nursing homes are disseminated across several German federal states and rural and urban regions, the results should be transferable to the entire population.
TRIAL REGISTRATION


ISRCTN15722923 (Registration date: 07 August 2019).",2020,"The non-pharmacological group intervention MAKS-s, which we will investigate in this study, is intended to reduce the behavioural and psychological symptoms and to improve the quality of life of such people.","['144 dementia participants should initially be included', 'people with severe dementia', 'people with severe dementia living in nursing homes (primary target group', 'people with severe dementia in inpatient care - study protocol']",['multicomponent non-pharmacological intervention'],"['behavioural and psychological symptoms of dementia and the quality of life of people with severe dementia', 'quality of life of such people']","[{'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3494652', 'cui_str': 'Severe dementia'}, {'cui': 'C0425205', 'cui_str': 'Lives in a nursing home'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C2599718', 'cui_str': 'Clinical Trial Protocols'}]","[{'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C4285807', 'cui_str': 'Behavioral and psychological symptoms of dementia'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3494652', 'cui_str': 'Severe dementia'}]",144.0,0.107316,"The non-pharmacological group intervention MAKS-s, which we will investigate in this study, is intended to reduce the behavioural and psychological symptoms and to improve the quality of life of such people.","[{'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Diehl', 'Affiliation': 'Centre for Health Services Research in Medicine, Department of Psychiatry and Psychotherapy, University Hospital Erlangen, Friedrich-Alexander University Erlangen-Nürnberg (FAU), Schwabachanlage 6, 91054, Erlangen, Germany. kristina.diehl@uk-erlangen.de.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Kratzer', 'Affiliation': 'Centre for Health Services Research in Medicine, Department of Psychiatry and Psychotherapy, University Hospital Erlangen, Friedrich-Alexander University Erlangen-Nürnberg (FAU), Schwabachanlage 6, 91054, Erlangen, Germany.'}, {'ForeName': 'Elmar', 'Initials': 'E', 'LastName': 'Graessel', 'Affiliation': 'Centre for Health Services Research in Medicine, Department of Psychiatry and Psychotherapy, University Hospital Erlangen, Friedrich-Alexander University Erlangen-Nürnberg (FAU), Schwabachanlage 6, 91054, Erlangen, Germany.'}]",BMC geriatrics,['10.1186/s12877-020-01807-1']
3355,33059633,"Design of the Pregnancy REmote MOnitoring II study (PREMOM II): a multicenter, randomized controlled trial of remote monitoring for gestational hypertensive disorders.","BACKGROUND


Observational data from the retrospective, non-randomized Pregnancy REmote MOnitoring I (PREMOM I) study showed that remote monitoring (RM) may be beneficial for prenatal observation of women at risk for gestational hypertensive disorders (GHD) in terms of clinical outcomes, health economics, and stakeholder perceptions. PREMOM II is a prospective, randomized, multicenter follow-up study that was performed to explore these promising results.
METHODS


After providing written consent, 3922 pregnant women aged ≥18 years who are at increased risk of developing GHD will be randomized (1:1:1 ratio) to (a) conventional care (control group), (b) a patient self-monitoring group, and (c) a midwife-assisted RM group. The women in each group will be further divided (1:1 ratio) to evaluate the outcomes of targeted or non-targeted (conventional) antihypertensive medication. Women will be recruited in five hospitals in Flanders, Belgium: Ziekenhuis Oost-Limburg, Universitaire Ziekenhuis Antwerpen, Universitaire Ziekenhuis Leuven, AZ Sint Jan Brugge-Oostende, and AZ Sint Lucas Brugge. The primary outcomes are: (1) numbers and types of prenatal visits; (2) maternal outcomes; (3) neonatal outcomes; (4) the applicability and performance of RM; and (5) compliance with RM and self-monitoring. The secondary outcomes are: (1) cost-effectiveness and willingness to pay; (2) patient-reported outcome measures (PROMS) questionnaires on the experiences of the participants; and (3) the maternal and perinatal outcomes according to the type of antihypertensive medication. Demographic, and maternal and neonatal outcomes are collected from the patients' electronic records. Blood pressure and compliance rate will be obtained from an online digital coordination platform for remote data handling. Information about the healthcare-related costs will be obtained from the National Coordination Committee of Belgian Health Insurance Companies (Intermutualistisch Agentschap). PROMS will be assessed using validated questionnaires.
DISCUSSION


To our knowledge, this is the first randomized trial comparing midwife-assisted RM and self-monitoring of prenatal blood pressure versus conventional management among women at increased risk of GHD. Positive results of this study may lead to a practical framework for caregivers, hospital management, and payers to introduce RM into the prenatal care programs of high-risk pregnancies.
TRIAL REGISTRATION


This study was registered on clinicaltrials.gov , identification number NCT04031430. Registered 24 July 2019, https://clinicaltrials.gov/ct2/show/NCT04031430?cond=premom+ii&draw=2&rank=1 .",2020,The primary outcomes are: (1) numbers and types of prenatal visits; (2) maternal outcomes; (3) neonatal outcomes; (4) the applicability and performance of RM; and (5) compliance with RM and self-monitoring.,"['women at increased risk of GHD', 'Women will be recruited in five hospitals in Flanders, Belgium', '3922 pregnant women aged ≥18\u2009years who are at increased risk of developing GHD', 'women at risk for gestational hypertensive disorders (GHD', 'gestational hypertensive disorders']","['targeted or non-targeted (conventional) antihypertensive medication', 'midwife-assisted RM and self-monitoring of prenatal blood pressure versus conventional management', 'remote monitoring (RM', 'conventional care (control group), (b) a patient self-monitoring group, and (c) a midwife-assisted RM group']","['Blood pressure and compliance rate', ' (1) numbers and types of prenatal visits; (2) maternal outcomes; (3) neonatal outcomes; (4) the applicability and performance of RM; and (5) compliance with RM and self-monitoring', 'cost-effectiveness and willingness to pay; (2) patient-reported outcome measures (PROMS) questionnaires on the experiences of the participants; and (3) the maternal and perinatal outcomes according to the type of antihypertensive medication']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1875156', 'cui_str': 'Flanders'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1444641', 'cui_str': 'At risk'}]","[{'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0026083', 'cui_str': 'Professional midwife'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1827763', 'cui_str': 'Prenatal visit'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C4277735', 'cui_str': 'Patient Reported Outcome Measures'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0178795', 'cui_str': 'Perinatal period'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",3922.0,0.142827,The primary outcomes are: (1) numbers and types of prenatal visits; (2) maternal outcomes; (3) neonatal outcomes; (4) the applicability and performance of RM; and (5) compliance with RM and self-monitoring.,"[{'ForeName': 'Dorien', 'Initials': 'D', 'LastName': 'Lanssens', 'Affiliation': 'Ziekenhuis Oost-Limburg, Future Health Department, Limburg Clinical Research Center/Mobile Health Unit, Genk, Belgium. Dorien.lanssens@uhasselt.be.'}, {'ForeName': 'Inge M', 'Initials': 'IM', 'LastName': 'Thijs', 'Affiliation': 'Ziekenhuis Oost-Limburg, Future Health Department, Limburg Clinical Research Center/Mobile Health Unit, Genk, Belgium.'}, {'ForeName': 'Wilfried', 'Initials': 'W', 'LastName': 'Gyselaers', 'Affiliation': 'Department of Obstetrics and Gynaecology, Ziekenhuis Oost-Limburg, Genk, Belgium.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMC pregnancy and childbirth,['10.1186/s12884-020-03291-2']
3356,33059638,Effects of prenatal mindfulness-based childbirth education on child-bearers' trajectories of distress: a randomized control trial.,"BACKGROUND


The perinatal period is a time of immense change, which can be a period of stress and vulnerability for mental health difficulties. Mindfulness-based interventions have shown promise for reducing distress, but further research is needed to identify long-term effects and moderators of mindfulness training in the perinatal period.
METHODS


The current study used data from a pilot randomized control trial (RCT) comparing a condensed mindfulness-based childbirth preparation program-the Mind in Labor (MIL)-to treatment as usual (TAU) to examine whether prenatal mindfulness training results in lower distress across the perinatal period, and whether the degree of benefit depends on child-bearers' initial levels of risk (i.e., depression and anxiety symptoms) and protective (i.e., mindfulness) characteristics. Child-bearers (N = 30) in their third trimester were randomized to MIL or TAU and completed assessments of distress-perceived stress, anxiety, and depressive symptoms-at pre-intervention, post-intervention, six-weeks post-birth, and one-year postpartum.
RESULTS


Multilevel modeling of distress trajectories revealed greater decreases from pre-intervention to 12-months postpartum for those in MIL compared to TAU, especially among child-bearers who were higher in anxiety and/or lower in dispositional mindfulness at baseline.
CONCLUSIONS


The current study offers preliminary evidence for durable perinatal mental health benefits following a brief mindfulness-based program and suggests further investigation of these effects in larger samples is warranted.
TRIAL REGISTRATION


The ClinicalTrials.gov identifier for the study is: NCT02327559 . The study was retrospectively registered on June 23, 2014.",2020,"Multilevel modeling of distress trajectories revealed greater decreases from pre-intervention to 12-months postpartum for those in MIL compared to TAU, especially among child-bearers who were higher in anxiety and/or lower in dispositional mindfulness at baseline.
","[""child-bearers' trajectories of distress""]","['MIL or TAU', 'prenatal mindfulness-based childbirth education', 'prenatal mindfulness training', 'condensed mindfulness-based childbirth preparation program-the Mind in Labor (MIL)-to treatment as usual (TAU']",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0231303', 'cui_str': 'Distress'}]","[{'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3658257', 'cui_str': 'Childbirth Education'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0150169', 'cui_str': 'Childbirth preparation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",[],,0.0852966,"Multilevel modeling of distress trajectories revealed greater decreases from pre-intervention to 12-months postpartum for those in MIL compared to TAU, especially among child-bearers who were higher in anxiety and/or lower in dispositional mindfulness at baseline.
","[{'ForeName': 'Marissa D', 'Initials': 'MD', 'LastName': 'Sbrilli', 'Affiliation': 'Department of Psychology, University of Illinois at Urbana-Champaign, Psychology Building, 603 E Daniel St, Champaign, IL, 61820, USA. sbrilli2@illinois.edu.'}, {'ForeName': 'Larissa G', 'Initials': 'LG', 'LastName': 'Duncan', 'Affiliation': 'School of Human Ecology, University of Wisconsin-Madison, Madison, USA.'}, {'ForeName': 'Heidemarie K', 'Initials': 'HK', 'LastName': 'Laurent', 'Affiliation': 'Department of Psychology, University of Illinois at Urbana-Champaign, Psychology Building, 603 E Daniel St, Champaign, IL, 61820, USA.'}]",BMC pregnancy and childbirth,['10.1186/s12884-020-03318-8']
3357,33059730,Equine-assisted biographical work (EABW) with individuals in the second half of life: study protocol of a multicentre randomised controlled trial.,"BACKGROUND


Equine-assisted therapy is more often practiced with children and adolescents than with the elderly, although individuals in the second half of life could also profit from it. This group, from the age of 50, is characterised by increasing emotional, social, health-related and cognitive changes; a critical life event, such as a neurological illness or loss of a family member, can increase the likelihood of subclinical depression. Individuals who exhibit depressive symptoms not necessarily diagnosed with a major depression may suffer from relevant losses of quality of life (e.g. sleep disorders, memory disorders, feelings of guilt, hopelessness). Despite the fact that the various healthcare systems are in general more frequently used, such individuals often do not receive adequate therapy. The processing of one's biography (reminiscence) is an elementary component of most psychotherapy approaches and has been demonstrated to treat and prevent the development of major depression. In this study, equine-assisted biographical work (EABW), a combination of equine-assisted therapy and biographical work, will be applied with individuals with subclinical depression in the second half of their life.
METHODS


This is a multicentre, prospective, randomised, controlled and open phase III study in enrolling participants with subclinical depression. The aim of the study is to evaluate whether a preventive, equine-assisted, age-specific treatment combining elements of equine-assisted intervention with those of biographical work offers better treatment potentials in comparison to a control group with no intervention. Study participants in the intervention group will receive weekly equine-assisted biographical work over a period of 8 weeks. The primary endpoint is the change in Beck Depression Inventory-II (BDI-II) in a pre-post comparison. Secondary endpoints include other health-related questionnaires including quality of life, reminiscence functions and anxiety.
DISCUSSION


The present study is the first randomised study examining the efficacy of biographical work with a horse and has the potential to establish an empirically based treatment for individuals in the second half of life and improving the symptoms of subclinical depression.
TRIAL REGISTRATION


German Clinical Trials Register DRKS00017010 . Registered on 01 April 2019.",2020,"This group, from the age of 50, is characterised by increasing emotional, social, health-related and cognitive changes; a critical life event, such as a neurological illness or loss of a family member, can increase the likelihood of subclinical depression.","['individuals in the second half of life', 'enrolling participants with subclinical depression', 'Individuals who exhibit depressive symptoms not necessarily diagnosed with a major depression', 'individuals with subclinical depression in the second half of their life']","['Equine-assisted biographical work (EABW', 'weekly equine-assisted biographical work']","['change in Beck Depression Inventory-II (BDI-II', 'health-related questionnaires including quality of life, reminiscence functions and anxiety']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0205211', 'cui_str': 'Subclinical'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0015272', 'cui_str': 'Exhibits as Topic'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]","[{'cui': 'C0019944', 'cui_str': 'Equus caballus'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.0674992,"This group, from the age of 50, is characterised by increasing emotional, social, health-related and cognitive changes; a critical life event, such as a neurological illness or loss of a family member, can increase the likelihood of subclinical depression.","[{'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Schmidt', 'Affiliation': 'Reittherapie Wittgenstein, Pulvermühle 3, 57319, Bad Berleburg, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Wartenberg-Demand', 'Affiliation': ', Schrecksbach, Germany.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Forstmeier', 'Affiliation': 'Developmental Psychology and Clinical Psychology of the Lifespan, Faculty II, University of Siegen, Adolf-Reichwein-Str. 2a, 57068, Siegen, Germany. simon.forstmeier@uni-siegen.de.'}]",Trials,['10.1186/s13063-020-04784-3']
3358,33059741,"Implementing a nurse-enabled, integrated, shared-care model involving specialists and general practitioners in breast cancer post-treatment follow-up: a study protocol for a phase II randomised controlled trial (the EMINENT trial).","BACKGROUND


Due to advances in early detection and cancer treatment, 5-year relative survival rates for early breast cancer surpass 90% in developed nations. There is increasing focus on promotion of wellness in survivorship and active approaches to reducing morbidity related to treatment; however, current models of follow-up care are heavily reliant on hospital-based specialist-led care. This study aims to test the feasibility of the EMINENT intervention for implementing an integrated, shared-care model involving both cancer centre specialists and community-based general practitioners for early breast cancer post-treatment follow-up.
METHODS


We describe a protocol for a phase II, randomised controlled trial with two parallel arms and 1:1 allocation. A total of 60 patients with early-stage breast cancer will be randomised to usual, specialist-led, follow-up care (as determined by the treating surgeons, medical oncologists, and radiation oncologists) or shared follow-up care intervention (i.e. EMINENT). EMINENT is a nurse-enabled, pre-specified shared-care pathway with follow-up responsibilities divided between cancer centre specialists (i.e. surgeons and oncologists) and general practitioners. The primary outcome is health-related quality of life as measured by the Functional Assessment of Cancer Therapy-Breast Cancer. Secondary outcomes include patient experience, acceptance, and satisfaction of care; dietary, physical activity, and sedentary behaviours; financial toxicity; adherence; health resource utilisation; and adverse events.
DISCUSSION


The trial is designed to identify the barriers to implementing a shared-care model for breast cancer survivors following treatment. Results of this study will inform a definitive trial testing the effects of shared-care model on health-related quality of life of breast cancer survivors, as well as its ability to alleviate the growing demands on the healthcare system.
TRIAL REGISTRATION


Australia and New Zealand Clinical Trials Registry ACTRN12619001594112 . Registered on 19 November 2019.",2020,"This study aims to test the feasibility of the EMINENT intervention for implementing an integrated, shared-care model involving both cancer centre specialists and community-based general practitioners for early breast cancer post-treatment follow-up.
","['breast cancer survivors', '60 patients with early-stage breast cancer', 'cancer centre specialists and community-based general practitioners for early breast cancer post-treatment follow-up']",[],"['health-related quality of life as measured by the Functional Assessment of Cancer Therapy-Breast Cancer', 'patient experience, acceptance, and satisfaction of care; dietary, physical activity, and sedentary behaviours; financial toxicity; adherence; health resource utilisation; and adverse events']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]",[],"[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0018741', 'cui_str': 'Health Resources'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",60.0,0.107727,"This study aims to test the feasibility of the EMINENT intervention for implementing an integrated, shared-care model involving both cancer centre specialists and community-based general practitioners for early breast cancer post-treatment follow-up.
","[{'ForeName': 'Raymond Javan', 'Initials': 'RJ', 'LastName': 'Chan', 'Affiliation': 'Division of Cancer Services, Proncess Alexandra Hospital, Metro South Health, Brisbane, Queensland, Australia. raymond.chan@qut.edu.au.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Emery', 'Affiliation': 'Department of General Practice and Centre for Cancer Research, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Katharine', 'Initials': 'K', 'LastName': 'Cuff', 'Affiliation': 'Division of Cancer Services, Proncess Alexandra Hospital, Metro South Health, Brisbane, Queensland, Australia.'}, {'ForeName': 'Laisa', 'Initials': 'L', 'LastName': 'Teleni', 'Affiliation': 'School of Nursing, Queensland University of Technology, Brisbane, Queensland, Australia.'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Simonsen', 'Affiliation': 'Division of Cancer Services, Proncess Alexandra Hospital, Metro South Health, Brisbane, Queensland, Australia.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Turner', 'Affiliation': ""Faculty of Medicine, University of Queensland & Royal Brisbane and Women's Hospital, Brisbane, Queensland, Australia.""}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Janda', 'Affiliation': 'Centre for Health Services Research, Faculty of Medicine, University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Mckavanagh', 'Affiliation': 'Division of Cancer Services, Proncess Alexandra Hospital, Metro South Health, Brisbane, Queensland, Australia.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Jones', 'Affiliation': 'Institute of Health and Biomedical Innovation, Queensland University of Technology, Brisbane, Queensland, Australia.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'McKinnell', 'Affiliation': 'Division of Cancer Services, Proncess Alexandra Hospital, Metro South Health, Brisbane, Queensland, Australia.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Gosper', 'Affiliation': 'McGrath Foundation & Princess Alexandra Hospital, Metro South Health, Brisbane, Queensland, Australia.'}, {'ForeName': 'Juanita', 'Initials': 'J', 'LastName': 'Ryan', 'Affiliation': 'Division of Surgery, Princess Alexandra Hospital, Metro South Health, Brisbane, Queensland, Australia.'}, {'ForeName': 'Ria', 'Initials': 'R', 'LastName': 'Joseph', 'Affiliation': 'School of Nursing, Queensland University of Technology, Brisbane, Queensland, Australia.'}, {'ForeName': 'Bethany', 'Initials': 'B', 'LastName': 'Crowe', 'Affiliation': 'Division of Cancer Services, Proncess Alexandra Hospital, Metro South Health, Brisbane, Queensland, Australia.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Harvey', 'Affiliation': 'Radiation Oncology Centre, Princess Alexandra Hospital, Metro South Health and University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Marissa', 'Initials': 'M', 'LastName': 'Ryan', 'Affiliation': 'Pharmacy Department, Princess Alexandra Hospital, Metro South Health, Brisbane, Queensland, Australia.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Carrington', 'Affiliation': 'Pharmacy Department, Princess Alexandra Hospital, Metro South Health, Brisbane, Queensland, Australia.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Nund', 'Affiliation': 'School of Health and Rehabilitation Sciences, University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Crichton', 'Affiliation': 'School of Nursing, Queensland University of Technology, Brisbane, Queensland, Australia.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'McPhail', 'Affiliation': 'Australian Centre For Health Services Innovation (AusHSI), Queensland University of Technology, Brisbane, Queensland, Australia.'}]",Trials,['10.1186/s13063-020-04740-1']
3359,33059755,"Tailored, psychological intervention for anxiety and/or depression in people with chronic obstructive pulmonary disease (COPD), TANDEM (Tailored intervention for ANxiety and DEpression Management in COPD): statistical analysis plan for a randomised controlled trial.","BACKGROUND


The aim of the TANDEM trial is to evaluate whether a tailored, psychological cognitive behavioural approach intervention, which links into, and optimises the effects of routine pulmonary rehabilitation (PR), leads to a reduction in mild/moderate anxiety and/or depression in people with moderate, severe or very severe chronic obstructive pulmonary disease.
METHODS AND DESIGN


TANDEM is a multi-centre, two-arm, parallel group, pragmatic, individually randomised controlled, superiority trial including an internal pilot. Participants are randomised to receive either the intervention (a tailored psychological intervention plus usual care including referral to PR) or the control (usual care including referral to PR). The designed randomisation ratio is 1.25:1 in favour of the intervention. The multiple-primary outcomes are participant depression and anxiety at 6 months, measured using the Hospital Anxiety and Depression Scale (HADS) depression and anxiety subscales.
RESULTS


This article describes the statistical analysis plan (SAP) for the TANDEM trial. In particular, we describe the general analysis principles, how we will handle missing data, the primary and secondary outcomes and how these will be analysed, sensitivity analyses for the multiple-primary outcomes, and any other analyses and data summaries. The SAP was developed and published prior to completion of follow-up of the last participant.
TRIAL REGISTRATION


ISRCTN registry ISRCTN59537391. Registered on 20 March 2017.",2020,Participants are randomised to receive either the intervention (a tailored psychological intervention plus usual care including referral to PR) or the control (usual care including referral to PR).,"['people with chronic obstructive pulmonary disease (COPD', 'people with moderate, severe or very severe chronic obstructive pulmonary disease']","['intervention (a tailored psychological intervention plus usual care including referral to PR) or the control (usual care including referral to PR', 'psychological intervention', 'routine pulmonary rehabilitation (PR']","['participant depression and anxiety at 6\u2009months, measured using the Hospital Anxiety and Depression Scale (HADS) depression and anxiety subscales']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C3641272', 'cui_str': 'Very severe'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}]",,0.140883,Participants are randomised to receive either the intervention (a tailored psychological intervention plus usual care including referral to PR) or the control (usual care including referral to PR).,"[{'ForeName': 'Claire L', 'Initials': 'CL', 'LastName': 'Chan', 'Affiliation': 'Institute of Population Health Sciences, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, Yvonne Carter Building, 58 Turner Street, London, E1 2AB, UK. c.l.chan@qmul.ac.uk.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Smuk', 'Affiliation': 'London School of Hygiene and Tropical Medicine, Keppel Street, London, WC1E 7HT, UK.'}, {'ForeName': 'Ratna', 'Initials': 'R', 'LastName': 'Sohanpal', 'Affiliation': 'Institute of Population Health Sciences, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, Yvonne Carter Building, 58 Turner Street, London, E1 2AB, UK.'}, {'ForeName': 'Hilary', 'Initials': 'H', 'LastName': 'Pinnock', 'Affiliation': 'Allergy and Respiratory Research Group, Usher Institute, The University of Edinburgh, Doorway 3, Medical School, Teviot Place, Edinburgh, EH8 9AG, UK.'}, {'ForeName': 'Stephanie J C', 'Initials': 'SJC', 'LastName': 'Taylor', 'Affiliation': 'Institute of Population Health Sciences, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, Yvonne Carter Building, 58 Turner Street, London, E1 2AB, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-020-04786-1']
3360,33059762,Engaging adolescents in changing behaviour (EACH-B): a study protocol for a cluster randomised controlled trial to improve dietary quality and physical activity.,"BACKGROUND


Poor diet and lack of physical activity are strongly linked to non-communicable disease risk, but modifying them is challenging. There is increasing recognition that adolescence is an important time to intervene; habits formed during this period tend to last, and physical and psychological changes during adolescence make it an important time to help individuals form healthier habits. Improving adolescents' health behaviours is important not only for their own health now and in adulthood, but also for the health of any future children. Building on LifeLab-an existing, purpose-built educational facility at the University of Southampton-we have developed a multi-component intervention for secondary school students called Engaging Adolescents in Changing Behaviour (EACH-B) that aims to motivate and support adolescents to eat better and be more physically active.
METHODS


A cluster randomised controlled trial is being conducted to evaluate the effectiveness of the EACH-B intervention. The primary outcomes of the intervention are self-reported dietary quality and objectively measured physical activity (PA) levels, both assessed at baseline and at 12-month follow-up. The EACH-B intervention consists of three linked elements: professional development for teachers including training in communication skills to support health behaviour change; the LifeLab educational module comprising in-school teaching of nine science lessons linked to the English National Curriculum and a practical day visit to the LifeLab facility; and a personalised digital intervention that involves social support and game features that promote eating better and being more active. Both the taught module and the LifeLab day are designed with a focus on the science behind the messages about positive health behaviours, such as diet and PA, for the adolescents now, in adulthood and their future offspring, with the aim of promoting personal plans for change. The EACH-B research trial aims to recruit approximately 2300 secondary school students aged 12-13 years from 50 schools (the clusters) from Hampshire and neighbouring counties. Participating schools will be randomised to either the control or intervention arm. The intervention will be run during two academic years, with continual recruitment of schools throughout the school year until the sample size is reached. The schools allocated to the control arm will receive normal schooling but will be offered the intervention after data collection for the trial is complete. An economic model will be developed to assess the cost-effectiveness of the EACH-B intervention compared with usual schooling.
DISCUSSION


Adolescents' health needs are often ignored and they can be difficult to engage in behaviour change. Building a cheap, sustainable way of engaging them in making healthier choices will benefit their long-term health and that of their future children.
TRIAL REGISTRATION


ISRCTN 74109264 . Registered on 30 August 2019. EACH-B is a cluster randomised controlled trial, funded by the National Institute for Health Research (RP-PG-0216-20004).",2020,"Improving adolescents' health behaviours is important not only for their own health now and in adulthood, but also for the health of any future children.",['2300 secondary school students aged 12-13\u2009years from 50 schools (the clusters) from Hampshire and neighbouring counties'],"['LifeLab educational module comprising in-school teaching of nine science lessons linked to the English National Curriculum and a practical day visit to the LifeLab facility; and a personalised digital intervention', 'EACH-B intervention', 'control arm will receive normal schooling']","['dietary quality and physical activity', 'self-reported dietary quality and objectively measured physical activity (PA) levels']","[{'cui': 'C0036530', 'cui_str': 'Secondary school'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0324247', 'cui_str': 'Hampshire pig'}]","[{'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0828215,"Improving adolescents' health behaviours is important not only for their own health now and in adulthood, but also for the health of any future children.","[{'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Strömmer', 'Affiliation': 'MRC Lifecourse Epidemiology Unit, Southampton General Hospital, University of Southampton, Southampton, UK.'}, {'ForeName': 'Millie', 'Initials': 'M', 'LastName': 'Barrett', 'Affiliation': 'MRC Lifecourse Epidemiology Unit, Southampton General Hospital, University of Southampton, Southampton, UK.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Woods-Townsend', 'Affiliation': 'NIHR Southampton Biomedical Research Centre, University Hospital Southampton, NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Janis', 'Initials': 'J', 'LastName': 'Baird', 'Affiliation': 'MRC Lifecourse Epidemiology Unit, Southampton General Hospital, University of Southampton, Southampton, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Farrell', 'Affiliation': 'NIHR Southampton Biomedical Research Centre, University Hospital Southampton, NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Lord', 'Affiliation': 'Southampton Health Technology Assessments Centre, University of Southampton, Southampton, UK.'}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Morrison', 'Affiliation': 'Centre for Clinical and Community Applications of Health Psychology, University of Southampton, Southampton, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Shaw', 'Affiliation': 'MRC Lifecourse Epidemiology Unit, Southampton General Hospital, University of Southampton, Southampton, UK.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Vogel', 'Affiliation': 'MRC Lifecourse Epidemiology Unit, Southampton General Hospital, University of Southampton, Southampton, UK.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Lawrence', 'Affiliation': 'MRC Lifecourse Epidemiology Unit, Southampton General Hospital, University of Southampton, Southampton, UK.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Lovelock', 'Affiliation': 'Southampton Education School, Faculty of Social Sciences, University of Southampton, Southampton, UK.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Bagust', 'Affiliation': 'Southampton Education School, Faculty of Social Sciences, University of Southampton, Southampton, UK.'}, {'ForeName': 'Judit', 'Initials': 'J', 'LastName': 'Varkonyi-Sepp', 'Affiliation': 'NIHR Southampton Biomedical Research Centre, University Hospital Southampton, NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Patsy', 'Initials': 'P', 'LastName': 'Coakley', 'Affiliation': 'MRC Lifecourse Epidemiology Unit, Southampton General Hospital, University of Southampton, Southampton, UK.'}, {'ForeName': 'Lyall', 'Initials': 'L', 'LastName': 'Campbell', 'Affiliation': 'NIHR Southampton Biomedical Research Centre, University Hospital Southampton, NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Ross', 'Initials': 'R', 'LastName': 'Anderson', 'Affiliation': 'NIHR Southampton Biomedical Research Centre, University Hospital Southampton, NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Horsfall', 'Affiliation': 'MRC Lifecourse Epidemiology Unit, Southampton General Hospital, University of Southampton, Southampton, UK.'}, {'ForeName': 'Neelam', 'Initials': 'N', 'LastName': 'Kalita', 'Affiliation': 'Southampton Health Technology Assessments Centre, University of Southampton, Southampton, UK.'}, {'ForeName': 'Olu', 'Initials': 'O', 'LastName': 'Onyimadu', 'Affiliation': 'Southampton Health Technology Assessments Centre, University of Southampton, Southampton, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Clarke', 'Affiliation': 'Hampshire County Council, Winchester, UK.'}, {'ForeName': 'Cyrus', 'Initials': 'C', 'LastName': 'Cooper', 'Affiliation': 'MRC Lifecourse Epidemiology Unit, Southampton General Hospital, University of Southampton, Southampton, UK.'}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Chase', 'Affiliation': 'Southampton City Council, Southampton, UK.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Lambrick', 'Affiliation': 'School of Health Sciences, Faculty of Environmental and Life Sciences, University of Southampton, Southampton, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Little', 'Affiliation': 'School of Primary Care, Population Sciences and Medical Education, University of Southampton, Southampton, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Hanson', 'Affiliation': 'NIHR Southampton Biomedical Research Centre, University Hospital Southampton, NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Godfrey', 'Affiliation': 'NIHR Southampton Biomedical Research Centre, University Hospital Southampton, NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Hazel', 'Initials': 'H', 'LastName': 'Inskip', 'Affiliation': 'MRC Lifecourse Epidemiology Unit, Southampton General Hospital, University of Southampton, Southampton, UK.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Barker', 'Affiliation': 'MRC Lifecourse Epidemiology Unit, Southampton General Hospital, University of Southampton, Southampton, UK. meb@mrc.soton.ac.uk.'}]",Trials,['10.1186/s13063-020-04761-w']
3361,33060077,"Efficacy of neoadjuvant atezolizumab treatment in patients with advanced urothelial bladder cancer according to the BASQ classification: a study protocol for an open-label, two-cohort, phase II trial.","INTRODUCTION


Atezolizumab is a programmed death ligand-1 inhibitor for urothelial bladder cancer treatment. Atezolizumab has become the standard therapy for patients with urothelial bladder cancer who are not responding to cisplatin-based chemotherapy and is also used as a first-line treatment in cisplatin-ineligible patients. However, the efficacy of atezolizumab as a neoadjuvant chemotherapy for radical cystectomy has not yet been published and is still under study. This trial investigates the effectiveness of basal/squamous-like (BASQ) classification in the selection of an effective target group of patients with muscle-invasive bladder cancer (MIBC) for neoadjuvant atezolizumab treatment.
METHODS AND ANALYSIS


This study is an open-label, two-cohort, phase II trial. It was designed to evaluate the efficacy of neoadjuvant atezolizumab treatment in patients with MIBC (T2-4N0M0) pathological responses after neoadjuvant chemotherapy and radical cystectomy. According to the molecular subtype characteristics of previous transurethral resection of the bladder specimens, patients are divided into two groups: luminal type (KRT5/6-KRT14-FOXA1+GATA3+) and basal type (KRT5/6+KRT14+FOXA1-GATA3-). Every 3 weeks, atezolizumab is administered at a dose of 1200 mg for three cycles prior to radical cystectomy in patients with MIBC. The primary end point is objective pathological responses in the intention-to-treat patients. The secondary end point is a 1-year progression-free survival difference according to the BASQ classification in patients who underwent neoadjuvant atezolizumab treatment.
ETHICS AND DISSEMINATION


The study protocol was approved by the Institutional Review Board of Seoul National University Hospital, Seoul, Republic of Korea (H 1806-051-950). The trial is registered at ClinicalTrials.gov. The trial results will be published in peer-reviewed journals and at conferences.
TRIAL REGISTRATION NUMBER


NCT03577132.",2020,"This trial investigates the effectiveness of basal/squamous-like (BASQ) classification in the selection of an effective target group of patients with muscle-invasive bladder cancer (MIBC) for neoadjuvant atezolizumab treatment.
","['patients with advanced urothelial bladder cancer according to the BASQ classification', 'patients with muscle-invasive bladder cancer (MIBC) for neoadjuvant atezolizumab treatment', 'patients with MIBC (T2-4N0M0) pathological responses after neoadjuvant chemotherapy and radical cystectomy', 'Seoul National University Hospital, Seoul, Republic of Korea (H 1806-051-950', 'patients with urothelial bladder cancer who are not responding to']","['cisplatin-based chemotherapy', 'basal/squamous-like (BASQ', 'Atezolizumab', 'neoadjuvant atezolizumab', 'luminal type (KRT5/6-KRT14-FOXA1+GATA3+) and basal type (KRT5/6+KRT14+FOXA1-GATA3', 'atezolizumab', 'neoadjuvant atezolizumab treatment']","['1-year progression-free survival difference', 'objective pathological responses']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0005684', 'cui_str': 'Malignant tumor of urinary bladder'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1827293', 'cui_str': 'Carcinoma of urinary bladder, invasive'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0194401', 'cui_str': 'Complete cystectomy'}, {'cui': 'C3850150', 'cui_str': 'Seoul'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C4708800', 'cui_str': '950'}]","[{'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0699493', 'cui_str': 'Luminal'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1307598', 'cui_str': 'GATA3 protein, human'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}]",,0.0514544,"This trial investigates the effectiveness of basal/squamous-like (BASQ) classification in the selection of an effective target group of patients with muscle-invasive bladder cancer (MIBC) for neoadjuvant atezolizumab treatment.
","[{'ForeName': 'Hyeong Dong', 'Initials': 'HD', 'LastName': 'Yuk', 'Affiliation': 'Urology, Seoul National University Hospital, Seoul, The Republic of Korea.'}, {'ForeName': 'Chang Wook', 'Initials': 'CW', 'LastName': 'Jeong', 'Affiliation': 'Urology, Seoul National University Hospital, Seoul, The Republic of Korea.'}, {'ForeName': 'Cheol', 'Initials': 'C', 'LastName': 'Kwak', 'Affiliation': 'Urology, Seoul National University Hospital, Seoul, The Republic of Korea.'}, {'ForeName': 'Hyeon', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Urology, Seoul National University Hospital, Seoul, The Republic of Korea.'}, {'ForeName': 'Kyung Chul', 'Initials': 'KC', 'LastName': 'Moon', 'Affiliation': 'College of Medicine, Seoul National University, Seoul, The Republic of Korea.'}, {'ForeName': 'Ja Hyeon', 'Initials': 'JH', 'LastName': 'Ku', 'Affiliation': 'Urology, Seoul National University Hospital, Seoul, The Republic of Korea kuuro70@snu.ac.kr.'}]",BMJ open,['10.1136/bmjopen-2019-035530']
3362,33060078,Cost-effectiveness of internet-based vestibular rehabilitation with and without physiotherapy support for adults aged 50 and older with a chronic vestibular syndrome in general practice.,"OBJECTIVES


To evaluate the cost-effectiveness of stand-alone and blended internet-based vestibular rehabilitation (VR) in comparison with usual care (UC) for chronic vestibular syndromes in general practice.
DESIGN


Economic evaluation alongside a three-armed, individually randomised controlled trial.
SETTING


59 Dutch general practices.
PARTICIPANTS


322 adults, aged 50 years and older with a chronic vestibular syndrome.
INTERVENTIONS


Stand-alone VR consisted of a 6-week, internet-based intervention with weekly online sessions and daily exercises. In blended VR, this intervention was supplemented with face-to-face physiotherapy support. UC group participants received usual general practice care without restrictions.
MAIN OUTCOME MEASURES


Societal costs, quality-adjusted life years (QALYs), Vertigo Symptom Scale-Short Form (VSS-SF), clinically relevant response (≥3 points VSS-SF improvement).
RESULTS


Mean societal costs in both the stand-alone and blended VR groups were statistically non-significantly higher than in the UC group (mean difference (MD) €504, 95% CI -1082 to 2268; and €916, 95% CI -663 to 2596). Both stand-alone and blended VR groups reported non-significantly more QALYs than the UC group (MD 0.02, 95% CI -0.00 to 0.04; and 0.01, 95% CI -0.01 to 0.03), and significantly better VSS-SF Scores (MD 3.8 points, 95% CI 1.7 to 6.0; and 3.3 points, 95% CI 1.3 to 5.2). For stand-alone VR compared with UC, the probability of cost-effectiveness was 0.95 at a willingness-to-pay ratio of €24 161/QALY, €600/point improvement in VSS-SF and €8000/clinically relevant responder in VSS-SF. For blended VR versus UC, the probability of cost-effectiveness was 0.95 at a willingness-to-pay ratio of €123 335/QALY, €900/point improvement in VSS-SF and €24 000/clinically relevant responder in VSS-SF.
CONCLUSION


Stand-alone and blended internet-based VR non-significantly increased QALYs and significantly reduced vestibular symptoms compared with UC, while costs in both groups were non-significantly higher. Stand-alone VR has the highest probability to be cost-effective compared with UC.
TRIAL REGISTRATION NUMBER


The Netherlands Trial Register NTR5712.",2020,"Mean societal costs in both the stand-alone and blended VR groups were statistically non-significantly higher than in the UC group (mean difference (MD) €504, 95% CI -1082 to 2268; and €916, 95% CI -663 to 2596).","['322 adults, aged 50 years and older with a chronic vestibular syndrome', '59 Dutch general practices', 'adults aged 50 and older with a chronic vestibular syndrome in general practice']","['usual general practice care without restrictions', 'UC', 'internet-based vestibular rehabilitation with and without physiotherapy support', 'stand-alone and blended internet-based vestibular rehabilitation (VR', 'Stand-alone VR consisted of a 6-week, internet-based intervention with weekly online sessions and daily exercises', 'usual care (UC']","['probability of cost-effectiveness', 'Societal costs, quality-adjusted life years (QALYs), Vertigo Symptom Scale-Short Form (VSS-SF), clinically relevant response (≥3 points VSS-SF improvement', 'Cost-effectiveness', 'VSS-SF Scores', 'vestibular symptoms', 'Mean societal costs']","[{'cui': 'C4517712', 'cui_str': '322'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}]","[{'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0200324', 'cui_str': 'Vestibular rehabilitation'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0560204', 'cui_str': 'Does stand alone'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C3898714', 'cui_str': 'Internet Intervention'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0042571', 'cui_str': 'Vertigo'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",322.0,0.114926,"Mean societal costs in both the stand-alone and blended VR groups were statistically non-significantly higher than in the UC group (mean difference (MD) €504, 95% CI -1082 to 2268; and €916, 95% CI -663 to 2596).","[{'ForeName': 'Vincent A', 'Initials': 'VA', 'LastName': 'van Vugt', 'Affiliation': 'Department of General Practice, Amsterdam UMC - Location VUMC, Amsterdam, The Netherlands v.vanvugt@amsterdamumc.nl.'}, {'ForeName': 'Judith E', 'Initials': 'JE', 'LastName': 'Bosmans', 'Affiliation': 'Amsterdam Public Health Research Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Aureliano P', 'Initials': 'AP', 'LastName': 'Finch', 'Affiliation': 'Amsterdam Public Health Research Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Johannes C', 'Initials': 'JC', 'LastName': 'van der Wouden', 'Affiliation': 'Department of General Practice, Amsterdam UMC - Location VUMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Henriëtte E', 'Initials': 'HE', 'LastName': 'van der Horst', 'Affiliation': 'Department of General Practice, Amsterdam UMC - Location VUMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Otto R', 'Initials': 'OR', 'LastName': 'Maarsingh', 'Affiliation': 'Department of General Practice, Amsterdam UMC - Location VUMC, Amsterdam, The Netherlands.'}]",BMJ open,['10.1136/bmjopen-2019-035583']
3363,33060086,Couples-based approach to HIV prevention for transgender women and their partners: study protocol for a randomised controlled trial testing the efficacy of the 'It Takes Two' intervention.,"INTRODUCTION


HIV transmission and acquisition risk among transgender women is particularly high in the context of primary partnerships. This project extends a previous pilot couples-focused HIV intervention programme, which was shown to be feasible, acceptable and promising in reducing sexual risk behaviour among transgender women and their partners. This randomised controlled trial (RCT) tests the efficacy of this culturally sensitive HIV prevention programme for HIV-serodiscordant and HIV-negative seroconcordant transgender women and their partners.
METHODS AND ANALYSIS


To finalise the protocol for trial, we used qualitative methods to hone eligibility criteria, refine the intervention and control manuals, and name and brand the intervention ('It Takes Two'). The RCT investigates the effects of the It Takes Two intervention on Composite Risk for HIV (CR-HIV) among 100 couples. CR-HIV is a binary indicator of couple HIV risk using validated measures of sexual behaviour, pre-exposure prophylaxis use among HIV-negative participants and viral suppression among participants living with HIV. Using a two-arm RCT, we will examine intervention effects on CR-HIV at 12-month follow-up comparing transgender women and their partners randomised to the intervention versus control (HIV prevention information only).
ETHICS AND DISSEMINATION


This study has been reviewed and approved by the University of California, San Francisco (19-28624) and the University of Michigan (HUM00147690) Institutional Review Boards. Participants provide informed consent before taking part of the study activities. Results will be published in peer-reviewed journals and presented at scientific conferences. We will make our results available to the community of researchers and general public interested in transgender health to avoid unintentional duplication of research, as well as to others in the health and social services community, including LGBT community-based organisations, AIDS service organisations and other transgender-serving organisations. The full de-identified dataset and codebook will be shared at the University of Michigan Digital Repository.
TRIAL REGISTRATION NUMBER


NCT04067661.",2020,"This randomised controlled trial (RCT) tests the efficacy of this culturally sensitive HIV prevention programme for HIV-serodiscordant and HIV-negative seroconcordant transgender women and their partners.
","['HIV-serodiscordant and HIV-negative seroconcordant transgender women and their partners', 'participants living with HIV', 'University of California, San Francisco (19-28624) and the University of Michigan (HUM00147690) Institutional Review Boards', 'transgender women and their partners', '100 couples']","['culturally sensitive HIV prevention programme', 'intervention versus control (HIV prevention information only']",['sexual risk behaviour'],"[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0481430', 'cui_str': 'HIV negative'}, {'cui': 'C0558141', 'cui_str': 'Transsexual'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0036152', 'cui_str': 'San Francisco'}, {'cui': 'C0025939', 'cui_str': 'Michigan'}, {'cui': 'C0086911', 'cui_str': 'Ethics Committee, Research'}, {'cui': 'C1319927', 'cui_str': 'Male-to-female transsexual'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0010222', 'cui_str': 'Couples'}]","[{'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",,0.0689383,"This randomised controlled trial (RCT) tests the efficacy of this culturally sensitive HIV prevention programme for HIV-serodiscordant and HIV-negative seroconcordant transgender women and their partners.
","[{'ForeName': 'Kristi E', 'Initials': 'KE', 'LastName': 'Gamarel', 'Affiliation': 'Department of Health Behavior and Health Education, University of Michigan School of Public Health, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Jae M', 'Initials': 'JM', 'LastName': 'Sevelius', 'Affiliation': 'Center for AIDS Prevention Studies, University of California, San Francisco, California, USA.'}, {'ForeName': 'Torsten B', 'Initials': 'TB', 'LastName': 'Neilands', 'Affiliation': 'Center for AIDS Prevention Studies, University of California, San Francisco, California, USA.'}, {'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'Kaplan', 'Affiliation': 'Department of Obstetrics, Gynecology, & Reproductive Sciences, University of California, San Francisco, California, USA.'}, {'ForeName': 'Mallory O', 'Initials': 'MO', 'LastName': 'Johnson', 'Affiliation': 'Center for AIDS Prevention Studies, University of California, San Francisco, California, USA.'}, {'ForeName': 'Tooru', 'Initials': 'T', 'LastName': 'Nemoto', 'Affiliation': 'Public Health Institute, Oakland, California, USA.'}, {'ForeName': 'Lynae A', 'Initials': 'LA', 'LastName': 'Darbes', 'Affiliation': 'Department of Health Behavior and Biological Sciences, University of Michigan School of Nursing, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Don', 'Initials': 'D', 'LastName': 'Operario', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, Rhode Island, USA Don_Operario@brown.edu.'}]",BMJ open,['10.1136/bmjopen-2020-038723']
3364,33060088,Ghost ileostomy versus conventional loop ileostomy in patients undergoing low anterior resection for rectal cancer (DRKS00013997): protocol for a randomised controlled trial.,"INTRODUCTION


Anastomotic leakage is the most important complication in colorectal surgery occurring in up to 20% after low anterior rectal resection. Therefore, a diverting ileostomy is usually created during low anterior resection to protect the anastomosis or rather to diminish the consequences in case of anastomotic leakage. The so-called virtual or ghost ileostomy is a pre-stage ostomy that can be easily exteriorised, if anastomotic leakage is suspected, in order to avoid the severe consequences of anastomotic leakage. On the other hand, an actual ileostomy can be avoided in patients, who do not develop anastomotic leakage.
METHODS AND ANALYSIS


The GHOST trial is a randomised controlled pilot trial comparing ghost ileostomy with conventional loop ileostomy in patients undergoing low anterior resection with total mesorectal excision for rectal cancer. After screening for eligibility and obtaining informed consent, a total of 60 adult patients are included in the trial. Patients are intraoperatively randomised to the trial groups in a 1:1 ratio after assuring that none of the intraoperative exclusion criteria are present. The main outcome parameter is the comprehensive complication index as a measure of safety. Further outcomes include specific complications, stoma-related complications, complications of ileostomy closure, frequency of transformation of ghost ileostomy into conventional ileostomy, frequency of terminal ostomy creation, proportion of patients with an ostomy at 6 months after index surgery, anorectal function (Wexner score) and quality of life assessed by the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and CR29 questionnaires. Follow-up for each individual patient will be 6 months.
ETHICS AND DISSEMINATION


The GHOST trial has been approved by the Medical Ethics Committee of Heidelberg University (reference number S-694/2017). If the intervention proves to be safe, loop ileostomy could be spared in a large proportion of patients, thus also avoiding stoma-related complications and a second operation (ileostomy closure) with its inherent complications in these patients.
TRIAL REGISTRATION NUMBER


German Clinical Trials Registry (DRKS00013997); Universal Trial Number: U1111-1208-9742.",2020,The GHOST trial is a randomised controlled pilot trial comparing ghost ileostomy with conventional loop ileostomy in patients undergoing low anterior resection with total mesorectal excision for rectal cancer.,"['patients undergoing low anterior resection with total mesorectal excision for rectal cancer', '60 adult patients are included in the trial', 'patients undergoing low anterior resection for rectal cancer']","['Ghost ileostomy versus conventional loop ileostomy', 'ileostomy with conventional loop ileostomy']","['specific complications, stoma-related complications, complications of ileostomy closure, frequency of transformation of ghost ileostomy into conventional ileostomy, frequency of terminal ostomy creation, proportion of patients with an ostomy at 6 months after index surgery, anorectal function (Wexner score) and quality of life assessed by the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and CR29 questionnaires', 'comprehensive complication index as a measure of safety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442000', 'cui_str': 'Lower anterior'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C1273428', 'cui_str': 'Total mesorectal excision'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0014776', 'cui_str': 'Erythrocyte Ghost'}, {'cui': 'C0020883', 'cui_str': 'Creation of ileostomy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0023985', 'cui_str': 'Creation of continent ileostomy'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C1955856', 'cui_str': 'Stoma site'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0192775', 'cui_str': 'Closure of ileostomy'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C3714584', 'cui_str': 'Transformation'}, {'cui': 'C0014776', 'cui_str': 'Erythrocyte Ghost'}, {'cui': 'C0020883', 'cui_str': 'Creation of ileostomy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0029473', 'cui_str': 'Construction of stoma'}, {'cui': 'C0441513', 'cui_str': 'Construction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",60.0,0.19472,The GHOST trial is a randomised controlled pilot trial comparing ghost ileostomy with conventional loop ileostomy in patients undergoing low anterior resection with total mesorectal excision for rectal cancer.,"[{'ForeName': 'Felix J', 'Initials': 'FJ', 'LastName': 'Hüttner', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Probst', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Mihaljevic', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Contin', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Colette', 'Initials': 'C', 'LastName': 'Dörr-Harim', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Ulrich', 'Affiliation': 'Surgical Department I, Städtische Kliniken Neuss, Lukaskrankenhaus GmbH, Neuss, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Schneider', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Markus W', 'Initials': 'MW', 'LastName': 'Büchler', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Germany markus.buechler@med.uni-heidelberg.de.'}, {'ForeName': 'Markus K', 'Initials': 'MK', 'LastName': 'Diener', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Knebel', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Germany.'}]",BMJ open,['10.1136/bmjopen-2020-038930']
3365,33060089,"Protocol description of the HOVON 141/VISION trial: a prospective, multicentre, randomised phase II trial of ibrutinib plus venetoclax in patients with creatinine clearance ≥30 mL/min who have relapsed or refractory chronic lymphocytic leukaemia (RR-CLL) with or without TP53 aberrations.","INTRODUCTION


Literature is scarce on the combination treatment of ibrutinib and venetoclax (IV) is scarce in relapsed or refractory chronic lymphocytic leukaemia (RR-CLL). Especially, the possibility of stopping ibrutinib in RR-CLL patients in deep remission is unclear.
METHODS AND ANALYSIS


In the HOVON 141/VISION trial, patients with RR-CLL are treated with 12 cycles of IV after a short induction with ibrutinib. Patients reaching undetectable minimal residual disease (uMRD) after 12 cycles of IV are randomised 1:2 to continue ibrutinib or stop treatment. The persistence of uMRD after stopping IV is studied. In addition, in patients who become positive for MRD again after stopping, IV treatment is reinitiated. The efficacy of this approach with regard to progression-free survival 12 months after randomisation is the primary endpoint of the study.
ETHICS AND DISSEMINATION


This protocol respects the Helsinki declaration and has been approved by the ethical committee of the Amsterdam Medical Center. Study findings will be disseminated through peer-reviewed papers. All patients who fulfil the inclusion criteria and no-exclusion criteria, and have signed the informed consent form are included in the study.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov Registry (NCT03226301).",2020,"The efficacy of this approach with regard to progression-free survival 12 months after randomisation is the primary endpoint of the study.
","['All patients who fulfil the inclusion criteria and no-exclusion criteria, and have signed the informed consent form are included in the study', 'patients with creatinine clearance ≥30 mL/min who have relapsed or refractory chronic lymphocytic leukaemia (RR-CLL) with or without TP53 aberrations', 'relapsed or refractory chronic lymphocytic leukaemia (RR-CLL']",['ibrutinib plus venetoclax'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0009797', 'cui_str': 'Informed Consent Forms'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0023434', 'cui_str': 'Chronic lymphocytic leukemia'}, {'cui': 'C0079419', 'cui_str': 'Genes, TP53'}]","[{'cui': 'C3501358', 'cui_str': 'Ibrutinib'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4079830', 'cui_str': 'venetoclax'}]",[],,0.197897,"The efficacy of this approach with regard to progression-free survival 12 months after randomisation is the primary endpoint of the study.
","[{'ForeName': 'Mark-David', 'Initials': 'MD', 'LastName': 'Levin', 'Affiliation': 'Department of Internal Medicine, Albert Schweitzer Hospital Location Dordwijk, Dordrecht, Zuid-Holland, The Netherlands.'}, {'ForeName': 'Arnon', 'Initials': 'A', 'LastName': 'Kater', 'Affiliation': 'Department of Hematology, Amsterdam UMC - Locatie AMC, Amsterdam, North Holland, The Netherlands a.p.kater@amsterdamumc.nl.'}, {'ForeName': 'Mattias', 'Initials': 'M', 'LastName': 'Mattsson', 'Affiliation': 'Department of Hematology, Uppsala Universitet, Uppsala, Sweden.'}, {'ForeName': 'Sabina', 'Initials': 'S', 'LastName': 'Kersting', 'Affiliation': 'Department of Hematology, Haga Hospital, Den Haag, Zuid-Holland, The Netherlands.'}, {'ForeName': 'Juha', 'Initials': 'J', 'LastName': 'Ranti', 'Affiliation': 'Department of Hematology, University of Turku, Turku, Finland.'}, {'ForeName': 'Hoa', 'Initials': 'H', 'LastName': 'Thi Tuyet Tran', 'Affiliation': 'Department of Hematology, Akershus University Hospital, Lorenskog, Norway.'}, {'ForeName': 'Kazem', 'Initials': 'K', 'LastName': 'Nasserinejad', 'Affiliation': 'HOVON Data Center, Department of Hematology, Erasmus MC, Rotterdam, Zuid-Holland, The Netherlands.'}, {'ForeName': 'Carsten Utoft', 'Initials': 'CU', 'LastName': 'Niemann', 'Affiliation': 'Department of Hematology, Rigshospitalet, Copenhagen, Denmark.'}]",BMJ open,['10.1136/bmjopen-2020-039168']
3366,33060615,Patient outcomes following GPs' educations about COPD: a cluster randomized controlled trial.,"This study aimed to compare patient outcomes following case method learning and traditional lectures as methods for continuing medical education (CME) about chronic obstructive pulmonary disease (COPD) for general practitioners (GPs) in Sweden. In a pragmatic cluster randomized controlled trial, COPD patients (n = 425; case method group n = 209, traditional lectures group n = 216) from 24 primary health care centers replied to questionnaires prior to and 18 months after a 2 × 2-h CME was given to GPs (n = 255). We measured changes in the scores of the Clinical COPD Questionnaire (CCQ), symptoms, needs for disease information, exacerbations, smoking, and use of pulmonary rehabilitation. The changes over time were similar for both CME methods. Patients who had used pulmonary rehabilitation increased from 13.2 to 17.8% (P = 0.04), and prevalence of smoking decreased from 28.9 to 25.1% (P = 0.003). In conclusion, neither of the used CME methods was superior than the other regarding patient outcomes. CME's primary value may lay in improving GPs' adherence to guidelines, which should lead to long-term positive changes in patient health.",2020,"Patients who had used pulmonary rehabilitation increased from 13.2 to 17.8% (P = 0.04), and prevalence of smoking decreased from 28.9 to 25.1% (P = 0.003).","['patients (n\u2009=\u2009425; case', 'continuing medical education (CME) about chronic obstructive pulmonary disease (COPD) for general practitioners (GPs) in Sweden']","[""GPs' educations about COPD"", 'method group n\u2009=\u2009209, traditional lectures group n\u2009=\u2009216) from 24 primary health care centers replied to questionnaires prior to and 18 months after a 2\u2009×\u20092-h CME was given to GPs', 'case method learning and traditional lectures', 'COPD']","['Clinical COPD Questionnaire (CCQ), symptoms, needs for disease information, exacerbations, smoking, and use of pulmonary rehabilitation', 'prevalence of smoking', 'pulmonary rehabilitation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3844105', 'cui_str': '425'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0013632', 'cui_str': 'Continuing Medical Education'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}]","[{'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C3266515', 'cui_str': 'Education about chronic obstructive pulmonary disease'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0441848', 'cui_str': 'Group N'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C4708905', 'cui_str': '216'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0013632', 'cui_str': 'Continuing Medical Education'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}]","[{'cui': 'C2919593', 'cui_str': 'Clinical chronic obstructive pulmonary disease questionnaire'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}]",,0.169765,"Patients who had used pulmonary rehabilitation increased from 13.2 to 17.8% (P = 0.04), and prevalence of smoking decreased from 28.9 to 25.1% (P = 0.003).","[{'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Sandelowsky', 'Affiliation': 'Karolinska Institutet, Department of Medicine, Division of Clinical Epidemiology, SE-171 76, Stockholm, Sweden. hanna.sandelowsky@ki.se.'}, {'ForeName': 'Ingvar', 'Initials': 'I', 'LastName': 'Krakau', 'Affiliation': 'Karolinska Institutet, Department of Medicine, Division of Clinical Epidemiology, SE-171 76, Stockholm, Sweden.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Modin', 'Affiliation': 'Karolinska Institutet, NVS, Section for Family Medicine and Primary Care, Alfred Nobels Allé 23, Huddinge, SE-141 83, Stockholm, Sweden.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Ställberg', 'Affiliation': 'Uppsala University, Department of Public Health and Caring Sciences, Family Medicine and Preventive Medicine, Box 564, SE-751 22, Uppsala, Sweden.'}, {'ForeName': 'Sven-Erik', 'Initials': 'SE', 'LastName': 'Johansson', 'Affiliation': 'Lund University, Center for Primary Health Care Research, Department of Clinical Sciences, SE-205 02, Malmö, Sweden.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Nager', 'Affiliation': 'Karolinska Institutet, NVS, Section for Family Medicine and Primary Care, Alfred Nobels Allé 23, Huddinge, SE-141 83, Stockholm, Sweden.'}]",NPJ primary care respiratory medicine,['10.1038/s41533-020-00204-w']
3367,33060632,Identifying a nasal gene expression signature associated with hyperinflation and treatment response in severe COPD.,"Hyperinflation contributes to dyspnea intensity in COPD. Little is known about the molecular mechanisms underlying hyperinflation and how inhaled corticosteroids (ICS) affect this important aspect of COPD pathophysiology. To investigate the effect of ICS/long-acting β 2 -agonist (LABA) treatment on both lung function measures of hyperinflation, and the nasal epithelial gene-expression profile in severe COPD. 117 patients were screened and 60 COPD patients entered a 1-month run-in period on low-dose ICS/LABA budesonide/formoterol (BUD/F) 200/6 one inhalation b.i.d. Patients were then randomly assigned to 3-month treatment with either a high dose BDP/F 100/6 two inhalations b.i.d. (n = 31) or BUD/F 200/6 two inhalations b.i.d. (n = 29). Lung function measurements and nasal epithelial gene-expression were assessed before and after 3-month treatment and validated in independent datasets. After 3-month ICS/LABA treatment, residual volume (RV)/total lung capacity (TLC)% predicted was reduced compared to baseline (p < 0.05). We identified a nasal gene-expression signature at screening that associated with higher RV/TLC% predicted values. This signature, decreased by ICS/LABA treatment was enriched for genes associated with increased p53 mediated apoptosis was replicated in bronchial biopsies of COPD patients. Finally, this signature was increased in COPD patients compared to controls in nasal, bronchial and small airways brushings. Short-term ICS/LABA treatment improves RV/TLC% predicted in severe COPD. Furthermore, it decreases the expression of genes involved in the signal transduction by the p53 class mediator, which is a replicable COPD gene expression signature in the upper and lower airways.Trial registration: ClinicalTrials.gov registration number NCT01351792 (registration date May 11, 2011), ClinicalTrials.gov registration number NCT00848406 (registration date February 20, 2009), ClinicalTrials.gov registration number NCT00158847 (registration date September 12, 2005).",2020,"This signature, decreased by ICS/LABA treatment was enriched for genes associated with increased p53 mediated apoptosis was replicated in bronchial biopsies of COPD patients.","['117 patients were screened and 60 COPD patients entered a 1-month run-in period on low-dose ICS', 'severe COPD']","['LABA budesonide/formoterol (BUD/F', 'LABA', 'ICS/long-acting β 2 -agonist (LABA']","['Lung function measurements and nasal epithelial gene-expression', 'p53 mediated apoptosis', 'residual volume (RV)/total lung capacity (TLC)% predicted', 'RV/TLC']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]","[{'cui': 'C1276807', 'cui_str': 'formoterol and budesonide'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0243192', 'cui_str': 'agonists'}]","[{'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0079419', 'cui_str': 'Genes, TP53'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0162638', 'cui_str': 'Apoptosis'}, {'cui': 'C0035190', 'cui_str': 'Residual respiratory volume'}, {'cui': 'C0086571', 'cui_str': 'Lung Capacities'}, {'cui': 'C0008569', 'cui_str': 'Thin Layer Chromatography'}]",117.0,0.157791,"This signature, decreased by ICS/LABA treatment was enriched for genes associated with increased p53 mediated apoptosis was replicated in bronchial biopsies of COPD patients.","[{'ForeName': 'Alen', 'Initials': 'A', 'LastName': 'Faiz', 'Affiliation': 'Department of Pulmonology, University of Groningen, University Medical Center Groningen, Hanzeplein 1, 9700 RB, Groningen, The Netherlands.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Imkamp', 'Affiliation': 'Department of Pulmonology, University of Groningen, University Medical Center Groningen, Hanzeplein 1, 9700 RB, Groningen, The Netherlands. k.imkamp@umcg.nl.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'van der Wiel', 'Affiliation': 'Department of Pulmonology, University of Groningen, University Medical Center Groningen, Hanzeplein 1, 9700 RB, Groningen, The Netherlands.'}, {'ForeName': 'Ilse M', 'Initials': 'IM', 'LastName': 'Boudewijn', 'Affiliation': 'Department of Pulmonology, University of Groningen, University Medical Center Groningen, Hanzeplein 1, 9700 RB, Groningen, The Netherlands.'}, {'ForeName': 'Gerard H', 'Initials': 'GH', 'LastName': 'Koppelman', 'Affiliation': 'GRIAC (Groningen Research Institute for Asthma and COPD), University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Corry-Anke', 'Initials': 'CA', 'LastName': 'Brandsma', 'Affiliation': 'GRIAC (Groningen Research Institute for Asthma and COPD), University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Huib A M', 'Initials': 'HAM', 'LastName': 'Kerstjens', 'Affiliation': 'Department of Pulmonology, University of Groningen, University Medical Center Groningen, Hanzeplein 1, 9700 RB, Groningen, The Netherlands.'}, {'ForeName': 'Wim', 'Initials': 'W', 'LastName': 'Timens', 'Affiliation': 'GRIAC (Groningen Research Institute for Asthma and COPD), University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Sebastiaan', 'Initials': 'S', 'LastName': 'Vroegop', 'Affiliation': 'Department of Pulmonary Diseases, Martini Hospital Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Henk R', 'Initials': 'HR', 'LastName': 'Pasma', 'Affiliation': 'Department of Pulmonary Diseases, Medical Center Leeuwarden, Leeuwarden, The Netherlands.'}, {'ForeName': 'Wim G', 'Initials': 'WG', 'LastName': 'Boersma', 'Affiliation': 'Department of Pulmonary Diseases, Medical Center Alkmaar, Alkmaar, The Netherlands.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Wielders', 'Affiliation': 'Department of Pulmonary Diseases, Catharina Hospital Eindhoven, Eindhoven, The Netherlands.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'van den Elshout', 'Affiliation': 'Department of Pulmonary Diseases, Rijnstate Hospital, Arnhem, The Netherlands.'}, {'ForeName': 'Khaled', 'Initials': 'K', 'LastName': 'Mansour', 'Affiliation': 'Department of Pulmonary Diseases, Orbis Concern, Sittard, The Netherlands.'}, {'ForeName': 'Katrina', 'Initials': 'K', 'LastName': 'Steiling', 'Affiliation': 'Division of Computational Biomedicine, Department of Medicine, Boston University School of Medicine, Boston, MA, USA.'}, {'ForeName': 'Avrum', 'Initials': 'A', 'LastName': 'Spira', 'Affiliation': 'Division of Computational Biomedicine, Department of Medicine, Boston University School of Medicine, Boston, MA, USA.'}, {'ForeName': 'Marc E', 'Initials': 'ME', 'LastName': 'Lenburg', 'Affiliation': 'Division of Computational Biomedicine, Department of Medicine, Boston University School of Medicine, Boston, MA, USA.'}, {'ForeName': 'Irene H', 'Initials': 'IH', 'LastName': 'Heijink', 'Affiliation': 'GRIAC (Groningen Research Institute for Asthma and COPD), University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Dirkje S', 'Initials': 'DS', 'LastName': 'Postma', 'Affiliation': 'Department of Pulmonology, University of Groningen, University Medical Center Groningen, Hanzeplein 1, 9700 RB, Groningen, The Netherlands.'}, {'ForeName': 'Maarten', 'Initials': 'M', 'LastName': 'van den Berge', 'Affiliation': 'Department of Pulmonology, University of Groningen, University Medical Center Groningen, Hanzeplein 1, 9700 RB, Groningen, The Netherlands.'}]",Scientific reports,['10.1038/s41598-020-72551-0']
3368,33060783,Duodenal acidification induces gastric relaxation and alters epithelial barrier function by a mast cell independent mechanism.,"Duodenal hyperpermeability and low-grade inflammation in functional dyspepsia is potentially related to duodenal acid exposure. We aimed to evaluate in healthy volunteers the involvement of mast cell activation on the duodenogastric reflex and epithelial integrity during duodenal acidification. This study consisted of 2 parts: (1) Duodenal infusion of acid or saline during thirty minutes in a randomized, double-blind cross-over manner with measurement of intragastric pressure (IGP) using high resolution manometry and collection of duodenal biopsies to measure epithelial barrier function and the expression of cell-to-cell adhesion proteins. Mast cells and eosinophils were counted and activation and degranulation status were assessed. (2) Oral treatment with placebo or mast cell stabilizer disodiumcromoglycate (DSCG) prior to duodenal perfusion with acid, followed by the procedures described above. Compared with saline, acidification resulted in lower IGP (P < 0.01), increased duodenal permeability (P < 0.01) and lower protein expression of claudin-3 (P < 0.001). Protein expression of tryptase (P < 0.001) was increased after acid perfusion. Nevertheless, an ultrastructural examination did not reveal degranulation of mast cells. DSCG did not modify the drop in IGP and barrier dysfunction induced by acid. Duodenal acidification activates an inhibitory duodenogastric motor reflex and, impairs epithelial integrity in healthy volunteers. However, these acid mediated effects occur independently from mast cell activation.",2020,"Compared with saline, acidification resulted in lower IGP (P < 0.01), increased duodenal permeability (P < 0.01) and lower protein expression of claudin-3 (P < 0.001).","['healthy volunteers', '2 parts']","['DSCG', 'acid or saline', 'double-blind cross-over manner with measurement of intragastric pressure (IGP', 'placebo or mast cell stabilizer disodiumcromoglycate (DSCG']","['IGP and barrier dysfunction', 'duodenal permeability', 'Mast cells and eosinophils were counted and activation and degranulation status', 'lower IGP', 'lower protein expression of claudin-3', 'Protein expression of tryptase', 'Duodenal hyperpermeability']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0449719', 'cui_str': 'Part'}]","[{'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0010366', 'cui_str': 'Genetic crossing over'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0442113', 'cui_str': 'Intragastric'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1268905', 'cui_str': 'Mast cell stabilizer'}]","[{'cui': 'C0442113', 'cui_str': 'Intragastric'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0013303', 'cui_str': 'Duodenal'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}, {'cui': 'C0024880', 'cui_str': 'Mast cell'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0242972', 'cui_str': 'Low protein diet'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0147080', 'cui_str': 'Tryptase'}]",,0.0943546,"Compared with saline, acidification resulted in lower IGP (P < 0.01), increased duodenal permeability (P < 0.01) and lower protein expression of claudin-3 (P < 0.001).","[{'ForeName': 'Hanne', 'Initials': 'H', 'LastName': 'Vanheel', 'Affiliation': 'Translational Research Center for Gastrointestinal Disorders, Department of Chronic Diseases, Metabolism and Ageing, KU Leuven, Herestraat 49, Box 701, 3000, Leuven, Belgium.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Vicario', 'Affiliation': ""Digestive Diseases Research Unit, Department of Gastroenterology, Institut de Recerca Vall d'Hebron, Hospital Universitari Vall d'Hebron, Universitat Autònoma de Barcelona, Barcelona, Spain.""}, {'ForeName': 'Dorien', 'Initials': 'D', 'LastName': 'Beeckmans', 'Affiliation': 'Translational Research Center for Gastrointestinal Disorders, Department of Chronic Diseases, Metabolism and Ageing, KU Leuven, Herestraat 49, Box 701, 3000, Leuven, Belgium.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Cocca', 'Affiliation': 'Department of Digestive Diseases, Campus Bio-Medico University, Endoscopy Unit-Azienda Ospedaliero Universitaria di Modena, Rome, Italy.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Wauters', 'Affiliation': 'Translational Research Center for Gastrointestinal Disorders, Department of Chronic Diseases, Metabolism and Ageing, KU Leuven, Herestraat 49, Box 701, 3000, Leuven, Belgium.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Accarie', 'Affiliation': 'Translational Research Center for Gastrointestinal Disorders, Department of Chronic Diseases, Metabolism and Ageing, KU Leuven, Herestraat 49, Box 701, 3000, Leuven, Belgium.'}, {'ForeName': 'Joran', 'Initials': 'J', 'LastName': 'Toth', 'Affiliation': 'Translational Research Center for Gastrointestinal Disorders, Department of Chronic Diseases, Metabolism and Ageing, KU Leuven, Herestraat 49, Box 701, 3000, Leuven, Belgium.'}, {'ForeName': 'Hans-Reimer', 'Initials': 'HR', 'LastName': 'Rodewald', 'Affiliation': 'Division of Cellular Immunology, German Cancer Research Center, Heidelberg, Germany.'}, {'ForeName': 'Gert', 'Initials': 'G', 'LastName': 'De Hertogh', 'Affiliation': 'Department of Pathology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Matteoli', 'Affiliation': 'Translational Research Center for Gastrointestinal Disorders, Department of Chronic Diseases, Metabolism and Ageing, KU Leuven, Herestraat 49, Box 701, 3000, Leuven, Belgium.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Boeckxstaens', 'Affiliation': 'Translational Research Center for Gastrointestinal Disorders, Department of Chronic Diseases, Metabolism and Ageing, KU Leuven, Herestraat 49, Box 701, 3000, Leuven, Belgium.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Tack', 'Affiliation': 'Translational Research Center for Gastrointestinal Disorders, Department of Chronic Diseases, Metabolism and Ageing, KU Leuven, Herestraat 49, Box 701, 3000, Leuven, Belgium.'}, {'ForeName': 'Ricard', 'Initials': 'R', 'LastName': 'Farre', 'Affiliation': 'Translational Research Center for Gastrointestinal Disorders, Department of Chronic Diseases, Metabolism and Ageing, KU Leuven, Herestraat 49, Box 701, 3000, Leuven, Belgium. ricard.farre@kuleuven.be.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Vanuytsel', 'Affiliation': 'Translational Research Center for Gastrointestinal Disorders, Department of Chronic Diseases, Metabolism and Ageing, KU Leuven, Herestraat 49, Box 701, 3000, Leuven, Belgium.'}]",Scientific reports,['10.1038/s41598-020-74491-1']
3369,33060889,Interim versus final results of the trial-not the flip side of the same coin!,,2018,,[],[],[],[],[],[],,0.0166811,,"[{'ForeName': 'Om Prakash', 'Initials': 'OP', 'LastName': 'Yadava', 'Affiliation': 'National Heart Institute, 49-50, Community Centre, New Delhi, 110065 India.'}]","Indian journal of thoracic and cardiovascular surgery : official organ, Association of Thoracic and Cardiovascular Surgeons of India",['10.1007/s12055-018-0682-7']
3370,33060948,Off-pump versus on-pump coronary artery bypass grafting-a surreal controversy?,"As per the findings of the SYNTAX Trial, it has been established that coronary artery bypass grafting (CABG) affords the best long-term results in patients with multivessel disease. However, it is still a point of contention whether 'off-pump' CABG (OPCAB) (on cardiopulmonary bypass) is better. Many studies appear to establish the superiority of one or the other. But there is still no well-planned multi-centre randomised controlled trial looking into all aspects of the issue that can, once and for all, put the controversy to rest. But as long as one is able to give the patient a good result, does it really matter whether the procedure is done off or on pump? This article looks at the available evidence with regard to various parameters comparing OPCAB and conventional CABG in an attempt to answer the question, if at all, it is a question!",2018,"As per the findings of the SYNTAX Trial, it has been established that coronary artery bypass grafting (CABG) affords the best long-term results in patients with multivessel disease.",['patients with multivessel disease'],['coronary artery bypass grafting (CABG'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}]",[],,0.0346279,"As per the findings of the SYNTAX Trial, it has been established that coronary artery bypass grafting (CABG) affords the best long-term results in patients with multivessel disease.","[{'ForeName': 'Anirban', 'Initials': 'A', 'LastName': 'Kundu', 'Affiliation': 'National Heart Institute, 49 Community Centre, New Delhi, Delhi 110065 India.'}, {'ForeName': 'Om Prakash', 'Initials': 'OP', 'LastName': 'Yadava', 'Affiliation': 'National Heart Institute, 49 Community Centre, New Delhi, Delhi 110065 India.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Taggart', 'Affiliation': 'University of Oxford, Oxford, UK.'}]","Indian journal of thoracic and cardiovascular surgery : official organ, Association of Thoracic and Cardiovascular Surgeons of India",['10.1007/s12055-018-0668-5']
3371,33060954,Hybrid myocardial revascularization.,"Background


In patients with advanced coronary artery disease (CAD), coronary artery bypass grafting (CABG) is associated with improved long-term outcomes while percutaneous coronary intervention (PCI) is associated with lower periprocedural complications. A new approach has emerged in the last decade that attempts to reap the benefits of bypass surgery and stenting while minimizing the shortcomings of each approach, hybrid myocardial revascularization (HMR).Three strategies for timing of the hybrid revascularization exists, each with their own inherent advantages and shortcomings: (1) CABG followed by PCI, (2) PCI followed by CABG, or (3) simultaneous CABG + PCI in a hybrid suite.
Studies


The results of the first randomized control trial comparing HMR (CABG first) and standard CABG, POL-MIDES (Prospective Randomized PilOt Study EvaLuating the Safety and Efficacy of Hybrid Revascularization in MultIvessel Coronary Artery DisEaSe), show HMR was feasible for 93.9% of patients whereas conversion to standard CABG was required for 6.1%. At 1 year, both groups had similar all-cause mortality (CABG 2.9% vs. HMR 2%) and major adverse clinical event (MACE)-free survival rates (CABG 92.2% vs. HMR 89.8%). Results of observational and comparative studies show that minimally invasive HMR procedures in patients with multivessel CAD carry minimal perioperative mortality risk and low morbidity and do not increase the risk of postoperative bleeding. The advantage they offer in comparison to classical surgical revascularization is indeed faster rehabilitation and patient's return to normal life.
Conclusion


Hybrid myocardial revascularization has been developed as a promising technique for the treatment of high-risk patients with CAD. Hybrid revascularization using minimally invasive surgical techniques combined with PCI offers to a part of patients an advantage of optimal revascularization of the most important artery of the heart, together with adequate myocardial revascularization in a relatively delicate way. Indeed, to patients with high operative risk of standard surgery, it offers an alternative which should be considered carefully.",2018,"At 1 year, both groups had similar all-cause mortality (CABG 2.9% vs. HMR 2%) and major adverse clinical event (MACE)-free survival rates (CABG 92.2% vs. HMR 89.8%).","['patients with high operative risk of standard surgery', 'MultIvessel Coronary Artery DisEaSe', 'patients with advanced coronary artery disease (CAD), coronary artery bypass grafting (CABG', 'high-risk patients with CAD', 'patients with multivessel CAD']","['percutaneous coronary intervention (PCI', 'HMR (CABG first) and standard CABG, POL-MIDES', 'Hybrid Revascularization', 'Hybrid revascularization using minimally invasive surgical techniques combined with PCI']","['cause mortality', 'risk of postoperative bleeding', 'perioperative mortality risk and low morbidity', 'major adverse clinical event (MACE)-free survival rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0027056', 'cui_str': 'Myocardial revascularization'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0032356', 'cui_str': 'Poland'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0032788', 'cui_str': 'Postoperative hemorrhage'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",,0.0353878,"At 1 year, both groups had similar all-cause mortality (CABG 2.9% vs. HMR 2%) and major adverse clinical event (MACE)-free survival rates (CABG 92.2% vs. HMR 89.8%).","[{'ForeName': 'Yugal Kishore', 'Initials': 'YK', 'LastName': 'Mishra', 'Affiliation': 'Department of Cardiac Surgery, Fortis Escorts Heart Institute, Okhla Road, New Delhi, 110025 India.'}, {'ForeName': 'Jatin', 'Initials': 'J', 'LastName': 'Yadav', 'Affiliation': 'Department of Cardiac Surgery, Fortis Escorts Heart Institute, Okhla Road, New Delhi, 110025 India.'}]","Indian journal of thoracic and cardiovascular surgery : official organ, Association of Thoracic and Cardiovascular Surgeons of India",['10.1007/s12055-018-0646-y']
3372,33026741,Interferon Beta-1b and Lopinavir-Ritonavir for Middle East Respiratory Syndrome.,"BACKGROUND


Whether combined treatment with recombinant interferon beta-1b and lopinavir-ritonavir reduces mortality among patients hospitalized with Middle East respiratory syndrome (MERS) is unclear.
METHODS


We conducted a randomized, adaptive, double-blind, placebo-controlled trial that enrolled patients at nine sites in Saudi Arabia. Hospitalized adults with laboratory-confirmed MERS were randomly assigned to receive recombinant interferon beta-1b plus lopinavir-ritonavir (intervention) or placebo for 14 days. The primary outcome was 90-day all-cause mortality, with a one-sided P-value threshold of 0.025. Prespecified subgroup analyses and safety analyses were conducted. Because of the pandemic of coronavirus disease 2019, the data and safety monitoring board requested an unplanned interim analysis and subsequently recommended the termination of enrollment and the reporting of the results.
RESULTS


A total of 95 patients were enrolled; 43 patients were assigned to the intervention group and 52 to the placebo group. A total of 12 patients (28%) in the intervention group and 23 (44%) in the placebo group died by day 90. The analysis of the primary outcome, with accounting for the adaptive design, yielded a risk difference of -19 percentage points (upper boundary of the 97.5% confidence interval [CI], -3; one-sided P = 0.024). In a prespecified subgroup analysis, treatment within 7 days after symptom onset led to lower 90-day mortality than use of placebo (relative risk, 0.19; 95% CI, 0.05 to 0.75), whereas later treatment did not. Serious adverse events occurred in 4 patients (9%) in the intervention group and in 10 (19%) in the placebo group.
CONCLUSIONS


A combination of recombinant interferon beta-1b and lopinavir-ritonavir led to lower mortality than placebo among patients who had been hospitalized with laboratory-confirmed MERS. The effect was greatest when treatment was started within 7 days after symptom onset. (Funded by the King Abdullah International Medical Research Center; MIRACLE ClinicalTrials.gov number, NCT02845843.).",2020,A combination of recombinant interferon beta-1b and lopinavir-ritonavir led to lower mortality than placebo among patients who had been hospitalized with laboratory-confirmed MERS.,"['A total of 95 patients were enrolled; 43 patients', 'Hospitalized adults with laboratory-confirmed MERS', 'enrolled patients at nine sites in Saudi Arabia', 'Middle East Respiratory Syndrome', 'patients hospitalized with Middle East respiratory syndrome (MERS', 'patients who had been hospitalized with laboratory-confirmed MERS']","['Interferon Beta-1b and Lopinavir-Ritonavir', 'placebo', 'recombinant interferon beta-1b and lopinavir-ritonavir', 'recombinant interferon beta-1b plus lopinavir-ritonavir (intervention) or placebo']","['90-day all-cause mortality', 'Serious adverse events', '90-day mortality']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C3694279', 'cui_str': 'Middle East respiratory syndrome'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0036243', 'cui_str': 'Saudi Arabia'}]","[{'cui': 'C0244713', 'cui_str': 'interferon beta-1b'}, {'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",95.0,0.768763,A combination of recombinant interferon beta-1b and lopinavir-ritonavir led to lower mortality than placebo among patients who had been hospitalized with laboratory-confirmed MERS.,"[{'ForeName': 'Yaseen M', 'Initials': 'YM', 'LastName': 'Arabi', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Ayed Y', 'Initials': 'AY', 'LastName': 'Asiri', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Abdullah M', 'Initials': 'AM', 'LastName': 'Assiri', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Hanan H', 'Initials': 'HH', 'LastName': 'Balkhy', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Al Bshabshe', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Majed', 'Initials': 'M', 'LastName': 'Al Jeraisy', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Yasser', 'Initials': 'Y', 'LastName': 'Mandourah', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Mohamed H A', 'Initials': 'MHA', 'LastName': 'Azzam', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Abdulhadi M', 'Initials': 'AM', 'LastName': 'Bin Eshaq', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Sameera', 'Initials': 'S', 'LastName': 'Al Johani', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Shmeylan', 'Initials': 'S', 'LastName': 'Al Harbi', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Hani A A', 'Initials': 'HAA', 'LastName': 'Jokhdar', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Ahmad M', 'Initials': 'AM', 'LastName': 'Deeb', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Ziad A', 'Initials': 'ZA', 'LastName': 'Memish', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Jesna', 'Initials': 'J', 'LastName': 'Jose', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Sameeh', 'Initials': 'S', 'LastName': 'Ghazal', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Al Faraj', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Ghaleb A', 'Initials': 'GA', 'LastName': 'Al Mekhlafi', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Nisreen M', 'Initials': 'NM', 'LastName': 'Sherbeeni', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Fatehi E', 'Initials': 'FE', 'LastName': 'Elzein', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Fahad', 'Initials': 'F', 'LastName': 'Al-Hameed', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Asim', 'Initials': 'A', 'LastName': 'Al Saedi', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Naif K', 'Initials': 'NK', 'LastName': 'Alharbi', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Fowler', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Frederick G', 'Initials': 'FG', 'LastName': 'Hayden', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Abdulaziz', 'Initials': 'A', 'LastName': 'Al-Dawood', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Abdelzaher', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Wail', 'Initials': 'W', 'LastName': 'Bajhmom', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Badriah M', 'Initials': 'BM', 'LastName': 'AlMutairi', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Mohamed A', 'Initials': 'MA', 'LastName': 'Hussein', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Adel', 'Initials': 'A', 'LastName': 'Alothman', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2015294']
3373,33021870,Ixazomib as Postinduction Maintenance for Patients With Newly Diagnosed Multiple Myeloma Not Undergoing Autologous Stem Cell Transplantation: The Phase III TOURMALINE-MM4 Trial.,"PURPOSE


Maintenance therapy prolongs progression-free survival (PFS) in patients with newly diagnosed multiple myeloma (NDMM) not undergoing autologous stem cell transplantation (ASCT) but has generally been limited to immunomodulatory agents. Other options that complement the induction regimen with favorable toxicity are needed.
PATIENTS AND METHODS


The phase III, double-blind, placebo-controlled TOURMALINE-MM4 study randomly assigned (3:2) patients with NDMM not undergoing ASCT who achieved better than or equal to partial response after 6-12 months of standard induction therapy to receive the oral proteasome inhibitor (PI) ixazomib or placebo on days 1, 8, and 15 of 28-day cycles as maintenance for 24 months. The primary endpoint was PFS since time of randomization.
RESULTS


Patients were randomly assigned to receive ixazomib (n = 425) or placebo (n = 281). TOURMALINE-MM4 met its primary endpoint with a 34.1% reduction in risk of progression or death with ixazomib versus placebo (median PFS since randomization, 17.4  v  9.4 months; hazard ratio [HR], 0.659; 95% CI, 0.542 to 0.801;  P  < .001; median follow-up, 21.1 months). Ixazomib significantly benefitted patients who achieved complete or very good partial response postinduction (median PFS, 25.6  v  12.9 months; HR, 0.586;  P  < .001). With ixazomib versus placebo, 36.6% versus 23.2% of patients had grade ≥ 3 treatment-emergent adverse events (TEAEs); 12.9% versus 8.0% discontinued treatment because of TEAEs. Common any-grade TEAEs included nausea (26.8%  v  8.0%), vomiting (24.2%  v  4.3%), and diarrhea (23.2%  v  12.3%). There was no increase in new primary malignancies (5.2%  v  6.2%); rates of on-study deaths were 2.6% versus 2.2%.
CONCLUSION


Ixazomib maintenance prolongs PFS with no unexpected toxicity in patients with NDMM not undergoing ASCT. To our knowledge, this is the first PI demonstrated in a randomized clinical trial to have single-agent efficacy for maintenance and is the first oral PI option in this patient population.",2020,"TOURMALINE-MM4 met its primary endpoint with a 34.1% reduction in risk of progression or death with ixazomib versus placebo (median PFS since randomization, 17.4  v  9.4 months; hazard ratio [HR], 0.659; 95% CI, 0.542 to 0.801;  P  < .001; median follow-up, 21.1 months).","['Patients', 'Patients With Newly Diagnosed Multiple Myeloma', 'patients with NDMM not undergoing ASCT', 'patients with newly diagnosed multiple myeloma (NDMM) not undergoing autologous stem cell transplantation (ASCT', 'MM4 study randomly assigned (3:2) patients with NDMM not undergoing ASCT who achieved better than or equal to partial response after 6-12 months of']","['Ixazomib maintenance', 'Autologous Stem Cell Transplantation', 'standard induction therapy to receive the oral proteasome inhibitor (PI) ixazomib or placebo', 'placebo', 'ixazomib', 'ixazomib versus placebo', 'Ixazomib']","['diarrhea', 'risk of progression or death', 'nausea', 'complete or very good partial response postinduction', 'new primary malignancies', 'vomiting', 'PFS since time of randomization', 'rates of on-study deaths', 'progression-free survival (PFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C1831743', 'cui_str': 'Transplantation of autologous hematopoietic stem cell'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C3273711', 'cui_str': 'ixazomib'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C1831743', 'cui_str': 'Transplantation of autologous hematopoietic stem cell'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1443643', 'cui_str': 'Proteasome inhibitor'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C3641222', 'cui_str': 'Very good'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",,0.215654,"TOURMALINE-MM4 met its primary endpoint with a 34.1% reduction in risk of progression or death with ixazomib versus placebo (median PFS since randomization, 17.4  v  9.4 months; hazard ratio [HR], 0.659; 95% CI, 0.542 to 0.801;  P  < .001; median follow-up, 21.1 months).","[{'ForeName': 'Meletios A', 'Initials': 'MA', 'LastName': 'Dimopoulos', 'Affiliation': 'Hematology and Medical Oncology, Department of Clinical Therapeutics, National and Kapodistrian University of Athens, School of Medicine, Athens, Greece.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Špička', 'Affiliation': 'First Department of Medicine, Department of Hematology, First Faculty of Medicine, Charles University and General Hospital in Prague, Prague, Czech Republic.'}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Quach', 'Affiliation': ""Department of Hematology, University of Melbourne, St Vincent's Hospital, Melbourne, Victoria, Australia.""}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Oriol', 'Affiliation': ""Institut d'Investigació contra la Leucèmia Josep Carreras and Institut Català d'Oncologia, Hospital Germans Trias i Pujol, Badalona, Spain.""}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Hájek', 'Affiliation': 'Department of Hemato-oncology, University Hospital Ostrava, University of Ostrava, and Faculty of Medicine, Ostrava, Czech Republic.'}, {'ForeName': 'Mamta', 'Initials': 'M', 'LastName': 'Garg', 'Affiliation': 'Hematology, Leicester Royal Infirmary/University Hospitals of Leicester NHS Trust, Leicester, United Kingdom.'}, {'ForeName': 'Meral', 'Initials': 'M', 'LastName': 'Beksac', 'Affiliation': 'Department of Hematology, Ankara University, Ankara, Turkey.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Bringhen', 'Affiliation': 'Division of Hematology, University of Torino, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Torino, Italy.'}, {'ForeName': 'Eirini', 'Initials': 'E', 'LastName': 'Katodritou', 'Affiliation': 'Department of Hematology, Theagenion Cancer Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Wee-Joo', 'Initials': 'WJ', 'LastName': 'Chng', 'Affiliation': 'Department of Hematology-Oncology, National University Cancer Institute, National University Health System, and Yong Loo Lin School of Medicine and Cancer Science Institute of Singapore, National University of Singapore, Singapore.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Leleu', 'Affiliation': 'Pôle Régional de Cancérologie, Department of Haematology, Centre Hospitalier Universitaire La Milétrie-Poitiers, Poitiers, France.'}, {'ForeName': 'Shinsuke', 'Initials': 'S', 'LastName': 'Iida', 'Affiliation': 'Department of Hematology and Oncology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.'}, {'ForeName': 'María-Victoria', 'Initials': 'MV', 'LastName': 'Mateos', 'Affiliation': 'Hematology, Hospital Universitario de Salamanca, University Hospital of Salamanca, Centro de Investigación del Cáncer, Instituto de Biología Molecular y Celular del Cáncer, (Universitario de Salamanca Consejo Superior de Investigaciones Científicas), Salamanca, Spain.'}, {'ForeName': 'Gareth', 'Initials': 'G', 'LastName': 'Morgan', 'Affiliation': 'Perlmutter Cancer Center, NYU Langone Health, New York, NY.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Vorog', 'Affiliation': 'Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Labotka', 'Affiliation': 'Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA.'}, {'ForeName': 'Bingxia', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Palumbo', 'Affiliation': 'Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA.'}, {'ForeName': 'Sagar', 'Initials': 'S', 'LastName': 'Lonial', 'Affiliation': 'Department of Hematology and Medical Oncology, Winship Cancer Institute of Emory University, Atlanta, GA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.02060']
3374,33050900,"CASCADE: a phase 2, randomized, double-blind, placebo-controlled, parallel-group trial to evaluate the effect of tezepelumab on airway inflammation in patients with uncontrolled asthma.","BACKGROUND


Patients with severe, uncontrolled asthma, particularly those with a non-eosinophilic phenotype, have a great unmet need for new treatments that act on a broad range of inflammatory pathways in the airway. Tezepelumab is a human monoclonal antibody that blocks the activity of thymic stromal lymphopoietin, an epithelial cytokine. In the PATHWAY phase 2b study (NCT02054130), tezepelumab reduced exacerbations by up to 71% in adults with severe, uncontrolled asthma, irrespective of baseline eosinophilic inflammatory status. This article reports the design and objectives of the phase 2 CASCADE study.
METHODS


CASCADE is an ongoing exploratory, phase 2, randomized, double-blind, placebo-controlled, parallel-group study aiming to assess the anti-inflammatory effects of tezepelumab 210 mg administered subcutaneously every 4 weeks for 28 weeks in adults aged 18-75 years with uncontrolled, moderate-to-severe asthma. The primary endpoint is the change from baseline to week 28 in airway submucosal inflammatory cells (eosinophils, neutrophils, T cells and mast cells) from bronchoscopic biopsies. Epithelial molecular phenotyping, comprising the three-gene-mean technique, will be used to assess participants' type 2 (T2) status to enable evaluation of the anti-inflammatory effect of tezepelumab across the continuum of T2 activation. Other exploratory analyses include assessments of the impact of tezepelumab on airway remodelling, including reticular basement membrane thickening and airway epithelial integrity. At the onset of the COVID-19 pandemic, the protocol was amended to address the possibility that site visits would be limited. The amendment allowed for: at-home dosing of study drug by a healthcare professional, extension of the treatment period by up to 6 months so patients are able to attend an onsite visit to undergo the end-of-treatment bronchoscopy, and replacement of final follow-up visits with a virtual or telephone visit.
DISCUSSION


CASCADE aims to determine the mechanisms by which tezepelumab improves clinical asthma outcomes by evaluating the effect of tezepelumab on airway inflammatory cells and remodelling in patients with moderate-to-severe, uncontrolled asthma. An important aspect of this study is the evaluation of the anti-inflammatory effect of tezepelumab across patients with differing levels of eosinophilic and T2 inflammation.
TRIAL REGISTRATION


NCT03688074 (ClinicalTrials.gov). Registered 28 September 2018.",2020,"Other exploratory analyses include assessments of the impact of tezepelumab on airway remodelling, including reticular basement membrane thickening and airway epithelial integrity.","['patients with moderate-to-severe, uncontrolled asthma', 'Patients with severe, uncontrolled asthma, particularly those with a non-eosinophilic phenotype', 'patients with uncontrolled asthma', 'adults with severe, uncontrolled asthma, irrespective of baseline eosinophilic inflammatory status', 'patients with differing levels of eosinophilic and T2 inflammation', 'adults aged 18-75\u2009years with uncontrolled, moderate-to-severe asthma']","['Tezepelumab', 'placebo', 'tezepelumab']","['airway inflammation', 'change from baseline to week 28 in airway submucosal inflammatory cells (eosinophils, neutrophils, T cells and mast cells']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0031437', 'cui_str': 'Phenotype'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C4550163', 'cui_str': 'tezepelumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1515025', 'cui_str': 'Submucosal route'}, {'cui': 'C0440752', 'cui_str': 'Inflammatory cell'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0024880', 'cui_str': 'Mast cell'}]",,0.343128,"Other exploratory analyses include assessments of the impact of tezepelumab on airway remodelling, including reticular basement membrane thickening and airway epithelial integrity.","[{'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Emson', 'Affiliation': 'Translational Science and Experimental Medicine, Research & Early Development, Respiratory & Immunology, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA. Claire.emson@astrazeneca.com.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Diver', 'Affiliation': 'University of Leicester, Leicester, UK.'}, {'ForeName': 'Latifa', 'Initials': 'L', 'LastName': 'Chachi', 'Affiliation': 'University of Leicester, Leicester, UK.'}, {'ForeName': 'Ayman', 'Initials': 'A', 'LastName': 'Megally', 'Affiliation': 'Respiratory & Immunology, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Cherrie', 'Initials': 'C', 'LastName': 'Small', 'Affiliation': 'Development Operations, BioPharmaceuticals R&D, AstraZeneca, Mississauga, Ontario, Canada.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Downie', 'Affiliation': 'Amgen, Thousand Oaks, CA, USA.'}, {'ForeName': 'Jane R', 'Initials': 'JR', 'LastName': 'Parnes', 'Affiliation': 'Amgen, Thousand Oaks, CA, USA.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Bowen', 'Affiliation': 'Biometrics, Respiratory & Immunology, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Gene', 'Initials': 'G', 'LastName': 'Colice', 'Affiliation': 'Respiratory & Immunology, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Chris E', 'Initials': 'CE', 'LastName': 'Brightling', 'Affiliation': 'University of Leicester, Leicester, UK.'}]",Respiratory research,['10.1186/s12931-020-01513-x']
3375,33050917,Evaluating the use of the EORTC patient-reported outcome measures for improving inter-rater reliability of CTCAE ratings in a mixed population of cancer patients: study protocol for a randomized controlled trial.,"BACKGROUND


In oncology, detection and tracking of adverse events are of top priority and rely mostly on the Common Terminology Criteria for Adverse Events (CTCAE). Besides, clinical trials use as well patient-reported outcomes (PROs) to assess those adverse events, which are only accessible through patient self-reporting, such as fatigue, pain, and sleep disorders. Especially those issues that are not visible from the outside are often misinterpreted and underestimated by mere provider ratings. This trial aims at evaluating the impact of providing PRO data to providers on the accuracy of adverse event assessment in terms of inter-rater reliability of CTCAE ratings.
METHODS


The trial uses a cross-sectional, unblinded, randomized controlled trial design with two trial arms and a single assessment time point. Eligible patients (aged 18 and above, any cancer diagnosis, currently under treatment, inpatient or day clinic setting, present symptom burden, no psychiatric or mental problems, written informed consent) complete an electronic version of the EORTC QLQ-C30 and 16 additional questions taken from the EORTC Item Library. PRO data is immediately processed and made available to CTCAE rating providers for conducting their ratings during the medical encounter. Patients are randomly assigned 1:1 to the intervention group (providers see PRO results on the same screen as the CTCAE rating) and the control group (no access to PRO data during the CTCAE rating). A superiority analysis will compare the inter-rater reliability (using intra-class correlation (ICC) coefficients) between the control and the intervention groups for each adverse event evaluated.
DISCUSSION


The presented trial will demonstrate potential benefits of using PRO measures to improve the reliability of CTCAE ratings in cancer trials and the identification of adverse events. The new insights gained may lead to a new strategy for evaluating adverse events in clinical trials by combining patient and provider ratings. This might also have implications for daily clinical practice and cancer registries.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04066868 . Registered on August 26, 2019. Competence Center for Clinical Trials of the Medical University of Innsbruck 20190513-2007. Registered on May 14, 2019. (version 6.0, March 18, 2019).",2020,The presented trial will demonstrate potential benefits of using PRO measures to improve the reliability of CTCAE ratings in cancer trials and the identification of adverse events.,"['Eligible patients (aged 18 and above, any cancer diagnosis, currently under treatment, inpatient or day clinic setting, present symptom burden, no psychiatric or mental problems, written informed consent) complete an electronic version of the EORTC QLQ-C30 and 16 additional questions taken from the EORTC Item Library', 'cancer patients']",['intervention group (providers see PRO'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0023621', 'cui_str': 'Library'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0033382', 'cui_str': 'Proline'}]",[],,0.150855,The presented trial will demonstrate potential benefits of using PRO measures to improve the reliability of CTCAE ratings in cancer trials and the identification of adverse events.,"[{'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Wintner', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, University Hospital of Psychiatry I, Medical University of Innsbruck, Anichstr. 35, 6020, Innsbruck, Austria. lisa.wintner@tirol-kliniken.at.'}, {'ForeName': 'Johannes M', 'Initials': 'JM', 'LastName': 'Giesinger', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, University Hospital of Psychiatry I, Medical University of Innsbruck, Anichstr. 35, 6020, Innsbruck, Austria.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Sztankay', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, University Hospital of Psychiatry I, Medical University of Innsbruck, Anichstr. 35, 6020, Innsbruck, Austria.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Bottomley', 'Affiliation': 'European Organisation for Research and Treatment of Cancer (EORTC Headquarters), Avenue E. Mounier 83/11, 1200, Brussels, Belgium.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Holzner', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, University Hospital of Psychiatry I, Medical University of Innsbruck, Anichstr. 35, 6020, Innsbruck, Austria.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-020-04745-w']
3376,33050920,Acute toxicity of normofractionated intensity modulated radiotherapy with simultaneous integrated boost compared to three-dimensional conformal radiotherapy with sequential boost in the adjuvant treatment of breast cancer.,"BACKGROUND


Intensity-modulated radiotherapy (IMRT) improves dose homogeneity and late toxicity compared to simple tangential techniques in adjuvant whole-breast radiotherapy for patients with breast cancer. Simultaneous-integrated boost (SIB) radiotherapy shortens the overall treatment time and improves dose homogeneity. However, prospective randomized trials regarding IMRT with SIB for adjuvant radiotherapy in breast cancer are lacking.
METHODS


The IMRT-MC2 (MINT) trial is a phase III prospective randomized controlled trial comparing IMRT with SIB (Arm A: whole breast 28 × 1.8 Gy, Boost 28 × 2.3 Gy) to 3D-conformal radiotherapy with a sequential boost (Arm B: whole breast 28 × 1.8 Gy, boost 8 × 2 Gy) in patients with breast cancer after BCS. Indication for boost radiotherapy was defined as age < 70 years or age > 70 years with presence of additional risk factors. This is a retrospective analysis of acute toxicity at one of two trial sites.
RESULTS


Five hundred two patients were randomized, of which 446 patients were eligible for this analysis. There was no statistically significant difference in terms of any grade radiation dermatitis between the two treatment arms at the end of treatment (p = 0.26). However, radiation dermatitis grade 2/3 (29.1% vs. 20.1 and 3.5% vs. 2.3%) occurred significantly more often in Arm A (p = 0.02). Breast/chest wall pain at the first follow-up visit was significantly more common in patients treated on Arm B (p = 0.02).
CONCLUSIONS


Treatment on both arms was well tolerated, however there were some differences regarding radiodermatitis and breast pain. Further analyses are ongoing.
TRIAL REGISTRATION


clinicaltrials.gov , NCT01322854 , registered 24th March 2011.",2020,There was no statistically significant difference in terms of any grade radiation dermatitis between the two treatment arms at the end of treatment (p = 0.26).,"['Five hundred two patients were randomized, of which 446 patients were eligible for this analysis', 'patients with breast cancer after BCS', 'breast cancer', 'patients with breast cancer', 'age\u2009<\u200970\u2009years or age\u2009>\u200970\u2009years with presence of additional risk factors', 'with SIB (Arm A: whole breast 28\u2009×\u20091.8']","['Simultaneous-integrated boost (SIB) radiotherapy', 'boost radiotherapy', 'adjuvant radiotherapy', 'Intensity-modulated radiotherapy (IMRT', 'IMRT', 'normofractionated intensity modulated radiotherapy']","['Breast/chest wall pain', 'grade radiation dermatitis', 'radiodermatitis and breast pain', 'Acute toxicity']","[{'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0917927', 'cui_str': 'Breast conserving surgery'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0457102', 'cui_str': 'Whole breast'}, {'cui': 'C4068742', 'cui_str': '1.8'}]","[{'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C2919491', 'cui_str': 'Boost radiation therapy'}, {'cui': 'C0242939', 'cui_str': 'Adjuvant Radiotherapy'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}]","[{'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0008035', 'cui_str': 'Chest wall pain'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0034561', 'cui_str': 'Radiation dermatitis'}, {'cui': 'C0024902', 'cui_str': 'Pain of breast'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0040539', 'cui_str': 'TO'}]",446.0,0.172031,There was no statistically significant difference in terms of any grade radiation dermatitis between the two treatment arms at the end of treatment (p = 0.26).,"[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Krug', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany. david.krug@uksh.de.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Köder', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Matthias F', 'Initials': 'MF', 'LastName': 'Häfner', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Arians', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Semi B', 'Initials': 'SB', 'LastName': 'Harrabi', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Stefan A', 'Initials': 'SA', 'LastName': 'Koerber', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Forster', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Ingmar', 'Initials': 'I', 'LastName': 'Schlampp', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Christof', 'Initials': 'C', 'LastName': 'Sohn', 'Affiliation': 'Department of Gynecology and Obstetrics, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Joerg', 'Initials': 'J', 'LastName': 'Heil', 'Affiliation': 'Department of Gynecology and Obstetrics, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Hof', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Juliane', 'Initials': 'J', 'LastName': 'Hörner-Rieber', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Debus', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany.'}]","Radiation oncology (London, England)",['10.1186/s13014-020-01652-x']
3377,33050924,Home Treatment of Older People with Symptomatic SARS-CoV-2 Infection (COVID-19): A structured Summary of a Study Protocol for a Multi-Arm Multi-Stage (MAMS) Randomized Trial to Evaluate the Efficacy and Tolerability of Several Experimental Treatments to Reduce the Risk of Hospitalisation or Death in outpatients aged 65 years or older (COVERAGE trial).,"OBJECTIVES


To assess the efficacy of several repurposed drugs to prevent hospitalisation or death in patients aged 65 or more with recent symptomatic SARS-CoV-2 infection (COVID-19) and no criteria for hospitalisation.
TRIAL DESIGN


Phase III, multi-arm (5) and multi-stage (MAMS), randomized, open-label controlled superiority trial. Participants will be randomly allocated 1:1:1:1:1 to the following strategies: Arm 1: Control arm Arms 2 to 5: Experimental treatment arms Planned interim analyses will be conducted at regular intervals. Their results will be reviewed by an Independent Data and Safety Monitoring Board. Experimental arms may be terminated for futility, efficacy or toxicity before the end of the trial. New experimental arms may be added if new evidence suggests that other treatments should be tested. A feasibility and acceptability substudy as well as an immunological substudy will be conducted alongside the trial.
PARTICIPANTS


Inclusion criteria are: 65-year-old or more; Positive test for SARS-CoV-2 on a nasopharyngeal swab; Symptoms onset within 3 days before diagnosis; No hospitalisation criteria; Signed informed consent; Health insurance. Exclusion criteria are: Inability to make an informed decision to participate (e.g.: dementia, guardianship); Rockwood Clinical Frailty Scale ≥7; Long QT syndrome; QTc interval > 500 ms; Heart rate <50/min; Kalaemia >5.5 mmol/L or <3.5 mmol/L; Ongoing treatment with piperaquine, halofantrine, dasatinib, nilotinib, hydroxyzine, domperidone, citalopram, escitalopram, potent inhibitors or inducers of cytochrome P450 CYP3A4 isoenzyme, repaglinide, azathioprine, 6-mercaptopurine, theophylline, pyrazinamide, warfarin; Known hypersensitivity to any of the trial drugs or to chloroquine and other 4-aminoquinolines, amodiaquine, mefloquine, glafenine, floctafenine, antrafenine, ARB; Hepatic porphyria; Liver failure (Child-Pugh stage ≥B); Stage 4 or 5 chronic kidney disease (GFR <30 mL/min/1.73 m²); Dialysis; Hypersentivity to lactose; Lactase deficiency; Abnormalities in galactose metabolism; Malabsorption syndrome; Glucose-6-phosphate dehydrogenase deficiency; Symptomatic hyperuricemia; Ileus; Colitis; Enterocolitis; Chronic hepatitis B virus disease. The trial is being conducted in France in the Bordeaux, Corse, Dijon, Nancy, Paris and Toulouse areas as well as in the Grand Duchy of Luxembourg. Participants are recruited either at home, nursing homes, general practices, primary care centres or hospital outpatient consultations.
INTERVENTION AND COMPARATOR


The four experimental treatments planned in protocol version 1.2 (April 8 th , 2020) are: (1) Hydroxychloroquine 200 mg, 2 tablets BID on day 0, 2 tablets QD from day 1 to 9; (2) Imatinib 400 mg, 1 tablet QD from day 0 to 9; (3) Favipiravir 200 mg, 12 tablets BID on day 0, 6 tablets BID from day 1 to 9; (4) Telmisartan 20 mg, 1 tablet QD from day 0 to 9. The comparator is a complex of vitamins and trace elements (AZINC Forme et Vitalité®), 1 capsule BID for 10 days, for which there is no reason to believe that they are active on the virus. In protocol version 1.2 (April 8th, 2020): People in the control arm will receive a combination of vitamins and trace elements; people in the experimental arms will receive hydroxychloroquine, or favipiravir, or imatinib, or telmisartan.
MAIN OUTCOME


The primary outcome is the proportion of participants with an incidence of hospitalisation and/or death between inclusion and day 14 in each arm.
RANDOMISATION


Participants are randomized in a 1:1:1:1:1 ratio to each arm using a web-based randomisation tool. Participants not treated with an ARB or ACEI prior to enrolment are randomized to receive the comparator or one of the four experimental drugs. Participants already treated with an ARB or ACEI are randomized to receive the comparator or one of the experimental drugs except telmisartan (i.e.: hydroxychloroquine, imatinib, or favipiravir). Randomisation is stratified on ACEI or ARBs treatment at inclusion and on the type of residence (personal home vs. nursing home).
BLINDING (MASKING)


This is an open-label trial. Participants, caregivers, investigators and statisticians are not blinded to group assignment.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)


A total of 1057 participants will be enrolled if all arms are maintained until the final analysis and no additional arm is added. Three successive futility interim analyses are planned, when the number of participants reaches 30, 60 and 102 in the control arm. Two efficacy analyses (interim n°3 and final) will be performed successively.
TRIAL STATUS


This describes the Version 1.2 (April 8 th , 2020) of the COVERAGE protocol that was approved by the French regulatory authority and ethics committee. The trial was opened for enrolment on April 15 th , 2020 in the Nouvelle Aquitaine region (South-West France). Given the current decline of the COVID-19 pandemic in France and its unforeseeable dynamic in the coming months, new trial sites in 5 other French regions and in Luxembourg are currently being opened. A revised version of the protocol was submitted to the regulatory authority and ethics committee on June 15 th , 2020. It contains the following amendments: (i) Inclusion criteria: age ≥65 replaced by age ≥60; time since first symptoms <3 days replaced by time since first symptoms <5 days; (ii) Withdrawal of the hydroxychloroquine arm (due to external data); (iii) increase in the number of trial sites.
TRIAL REGISTRATION


The trial was registered on Clinical Trials.gov on April 22 nd , 2020 (Identifier: NCT04356495): and on EudraCT on April 10 th , 2020 (Identifier: 2020-001435-27).
FULL PROTOCOL


The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest of expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2).",2020,"The primary outcome is the proportion of participants with an incidence of hospitalisation and/or death between inclusion and day 14 in each arm.
","['Participants not treated with an ARB or ACEI prior to enrolment', '1057 participants will be enrolled if all arms are maintained until the final analysis and no additional arm is added', 'patients aged 65 or more with recent symptomatic SARS-CoV-2 infection (COVID-19) and no criteria for hospitalisation', 'on April 10 th , 2020 (Identifier: 2020-001435-27', 'Inclusion criteria are: 65-year-old or more; Positive test for SARS-CoV-2 on a nasopharyngeal swab; Symptoms onset within 3 days before diagnosis', 'outpatients aged 65 years or older (COVERAGE trial', 'Older People with Symptomatic SARS-CoV-2 Infection (COVID-19', 'enrolment on April 15 th , 2020 in the Nouvelle Aquitaine region (South-West France', 'QT syndrome; QTc interval > 500 ms; Heart rate <50/min; Kalaemia >5.5 mmol/L or <3.5 mmol/L; Ongoing treatment with piperaquine, halofantrine, dasatinib, nilotinib', 'Participants already treated with an ARB or ACEI', 'Participants are recruited either at home, nursing homes, general practices, primary care centres or hospital outpatient consultations']","['hydroxychloroquine', 'hydroxyzine, domperidone, citalopram, escitalopram, potent inhibitors or inducers of cytochrome P450 CYP3A4 isoenzyme, repaglinide, azathioprine, 6-mercaptopurine, theophylline, pyrazinamide, warfarin', 'hydroxychloroquine, or favipiravir, or imatinib, or telmisartan', 'Hydroxychloroquine', 'chloroquine and other 4-aminoquinolines, amodiaquine, mefloquine, glafenine, floctafenine, antrafenine', 'Telmisartan', 'Multi-Arm Multi-Stage (MAMS', 'telmisartan (i.e.: hydroxychloroquine, imatinib, or favipiravir', 'EudraCT']","['proportion of participants with an incidence of hospitalisation and/or death', 'Risk of Hospitalisation or Death', 'Efficacy and Tolerability', 'hospitalisation or death', 'futility, efficacy or toxicity']","[{'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0521942', 'cui_str': 'Angiotensin II receptor antagonist'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0600091', 'cui_str': 'Identifier'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0444192', 'cui_str': 'Nasopharyngeal swab'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0037769', 'cui_str': 'West syndrome'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0860814', 'cui_str': 'QTc'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0071105', 'cui_str': 'piperaquine'}, {'cui': 'C0120726', 'cui_str': 'halofantrine'}, {'cui': 'C1455147', 'cui_str': 'dasatinib'}, {'cui': 'C1721377', 'cui_str': 'nilotinib'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0020404', 'cui_str': 'Hydroxyzine'}, {'cui': 'C0013015', 'cui_str': 'Domperidone'}, {'cui': 'C0008845', 'cui_str': 'Citalopram'}, {'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0008381', 'cui_str': 'Cholesterol monooxygenase (side-chain cleaving)'}, {'cui': 'C1142644', 'cui_str': 'cytochrome P450 3A4 protein, human'}, {'cui': 'C0022173', 'cui_str': 'Isozymes'}, {'cui': 'C0246689', 'cui_str': 'repaglinide'}, {'cui': 'C0004482', 'cui_str': 'Azathioprine'}, {'cui': 'C0000618', 'cui_str': 'mercaptopurine'}, {'cui': 'C0039771', 'cui_str': 'Theophylline'}, {'cui': 'C0034239', 'cui_str': 'Pyrazinamide'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C1138226', 'cui_str': 'favipiravir'}, {'cui': 'C0935989', 'cui_str': 'imatinib'}, {'cui': 'C0248719', 'cui_str': 'telmisartan'}, {'cui': 'C0008269', 'cui_str': 'Chloroquine'}, {'cui': 'C0048060', 'cui_str': '4-aminoquinoline'}, {'cui': 'C0002641', 'cui_str': 'Amodiaquine'}, {'cui': 'C0025153', 'cui_str': 'Mefloquine'}, {'cui': 'C0017592', 'cui_str': 'glafenine'}, {'cui': 'C0016245', 'cui_str': 'floctafenine'}, {'cui': 'C0052135', 'cui_str': 'antrafenine'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0086322', 'cui_str': 'Futility'}, {'cui': 'C0040539', 'cui_str': 'TO'}]",1057.0,0.200195,"The primary outcome is the proportion of participants with an incidence of hospitalisation and/or death between inclusion and day 14 in each arm.
","[{'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Duvignaud', 'Affiliation': 'CHU Bordeaux, Department of Infectious Diseases and Tropical Medicine, Division of Tropical Medicine and Clinical International Health, F-33000, Bordeaux, France. alexandre.duvignaud@chu-bordeaux.fr.'}, {'ForeName': 'Edouard', 'Initials': 'E', 'LastName': 'Lhomme', 'Affiliation': 'Univ. Bordeaux, Inserm, CHU Bordeaux, CIC 1401, EUCLID/F-CRIN Clinical Trials Platform, F-33000, Bordeaux, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Pistone', 'Affiliation': 'CHU Bordeaux, Department of Infectious Diseases and Tropical Medicine, Division of Tropical Medicine and Clinical International Health, F-33000, Bordeaux, France.'}, {'ForeName': 'Racha', 'Initials': 'R', 'LastName': 'Onaisi', 'Affiliation': 'Department of General Practice, Univ. Bordeaux, F-33000, Bordeaux, France.'}, {'ForeName': 'Rémi', 'Initials': 'R', 'LastName': 'Sitta', 'Affiliation': 'Univ. Bordeaux, Inserm, CHU Bordeaux, CIC 1401, EUCLID/F-CRIN Clinical Trials Platform, F-33000, Bordeaux, France.'}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Journot', 'Affiliation': 'Inserm U1219, Univ. Bordeaux, IRD, F-33000, Bordeaux, France.'}, {'ForeName': 'Duc', 'Initials': 'D', 'LastName': 'Nguyen', 'Affiliation': 'CHU Bordeaux, Department of Infectious Diseases and Tropical Medicine, Division of Tropical Medicine and Clinical International Health, F-33000, Bordeaux, France.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Peiffer-Smadja', 'Affiliation': 'CHU Bichat Claude Bernard, Department of Infectious Diseases and Tropical Medicine, APHP, F-75000, Paris, France.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Crémer', 'Affiliation': 'Department of Cardiology - Hypertension, CHU Bordeaux, F-33000, Bordeaux, France.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Bouchet', 'Affiliation': 'Inserm U1219, Univ. Bordeaux, F-33000, Bordeaux, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Darnaud', 'Affiliation': 'Centre Hospitalier de Bastia, Service de Chirurgie Spécialisée & Unité de Recherche Clinique, F-20200, Bastia, France.'}, {'ForeName': 'Delphine', 'Initials': 'D', 'LastName': 'Poitrenaud', 'Affiliation': ""Department of Infectious Diseases and Tropical Medicine, Centre Hospitalier d'Ajaccio, F-20090, Ajaccio, France.""}, {'ForeName': 'Lionel', 'Initials': 'L', 'LastName': 'Piroth', 'Affiliation': 'Department of Infectious Diseases and Tropical Medicine, CHU Dijon, F-21079, Dijon, France.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Binquet', 'Affiliation': 'Inserm, CHU Dijon, CIC-EC 1432, F-21000, Dijon, France.'}, {'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Michel', 'Affiliation': 'Centre Medical de Steinsel, Steinsel, Luxembourg.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Lefèvre', 'Affiliation': 'Department of Infectious Diseases and Tropical Medicine, CHU Nancy, F-54000, Nancy, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Lebeaux', 'Affiliation': 'Department of Infectious Diseases and Tropical Medicine, Hôpital Européen Georges Pompidou, APHP, F-75000, Paris, France.'}, {'ForeName': 'Josselin', 'Initials': 'J', 'LastName': 'Lebel', 'Affiliation': 'Department of General Practice, Université de Paris, F-75018, Paris, France.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Dupouy', 'Affiliation': 'MSPU Pins Justaret, F-31860, Pins Justaret, France.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Roussillon', 'Affiliation': 'Clinical Research and Innovation Department, Safety and vigilance, CHU Bordeaux, F-33000, Bordeaux, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Gimbert', 'Affiliation': 'Clinical Research and Innovation Department, CHU Bordeaux, F-33000, Bordeaux, France.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Wittkop', 'Affiliation': 'CHU Bordeaux, Pôle de Santé Publique, F-33000, Bordeaux, France.'}, {'ForeName': 'Rodolphe', 'Initials': 'R', 'LastName': 'Thiébaut', 'Affiliation': 'Univ. Bordeaux, Inserm, CHU Bordeaux, CIC 1401, EUCLID/F-CRIN Clinical Trials Platform, F-33000, Bordeaux, France.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Orne-Gliemann', 'Affiliation': 'Inserm U1219, Univ. Bordeaux, IRD, F-33000, Bordeaux, France.'}, {'ForeName': 'Jean-Philippe', 'Initials': 'JP', 'LastName': 'Joseph', 'Affiliation': 'Department of General Practice, CIC 1401, Univ. Bordeaux, F-33000, Bordeaux, France.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Richert', 'Affiliation': 'Univ. Bordeaux, Inserm, CHU Bordeaux, CIC 1401, EUCLID/F-CRIN Clinical Trials Platform, F-33000, Bordeaux, France.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Anglaret', 'Affiliation': 'Inserm U1219, Univ. Bordeaux, IRD, F-33000, Bordeaux, France.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Malvy', 'Affiliation': 'CHU Bordeaux, Department of Infectious Diseases and Tropical Medicine, Division of Tropical Medicine and Clinical International Health, F-33000, Bordeaux, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-020-04619-1']
3378,33051441,Propranolol-induced inhibition of unconditioned stimulus-reactivated fear memory prevents the return of fear in humans.,"Fear memories can be reactivated by a fear-associated conditioned stimulus (CS) or unconditioned stimulus (US) and then undergo reconsolidation. Propranolol administration during CS retrieval-induced reconsolidation can impair fear memory that is specific to the reactivated CS. However, from a practical perspective, the US is often associated with multiple CSs, and each CS can induce a fear response. The present study sought to develop and test a US-based memory retrieval interference procedure with propranolol to disrupt the original fear memory and eliminate all CS-associated fear responses in humans. We recruited 127 young healthy volunteers and conducted three experiments. All of the subjects acquired fear conditioning, after which they received the β-adrenergic receptor antagonist propranolol (40 mg) or placebo (vitamin C) and were exposed to the US or CS to reactivate the original fear memory. Fear responses were measured. Oral propranolol administration 1 h before US retrieval significantly decreased subsequent fear responses and disrupted associations between all CSs and the US. However, propranolol administration before CS retrieval only inhibited the fear memory that was related to the reactivated CS. Moreover, the propranolol-induced inhibition of fear memory reconsolidation that was retrieved by the US had a relatively long-lasting effect (at least 2 weeks) and was also effective for remote fear memory. These findings indicate that the US-based memory retrieval interference procedure with propranolol can permanently decrease the fear response and prevent the return of fear for all CSs in humans. This procedure may open new avenues for treating fear-related disorders.",2020,Oral propranolol administration 1 h before US retrieval significantly decreased subsequent fear responses and disrupted associations between all CSs and the US.,"['humans', '127 young healthy volunteers']","['Propranolol', 'β-adrenergic receptor antagonist propranolol', 'propranolol', 'placebo (vitamin C', 'Oral propranolol']","['subsequent fear responses', 'Fear responses', 'fear response', 'fear memory']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0033497', 'cui_str': 'Propranolol'}, {'cui': 'C0242889', 'cui_str': 'Substance with adrenergic receptor antagonist mechanism of action'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}]",127.0,0.0126613,Oral propranolol administration 1 h before US retrieval significantly decreased subsequent fear responses and disrupted associations between all CSs and the US.,"[{'ForeName': 'Jiahui', 'Initials': 'J', 'LastName': 'Deng', 'Affiliation': 'Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Chinese Academy of Medical Sciences Research Unit (No.2018RU006), Peking University, Beijing, China.'}, {'ForeName': 'Le', 'Initials': 'L', 'LastName': 'Shi', 'Affiliation': 'Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Chinese Academy of Medical Sciences Research Unit (No.2018RU006), Peking University, Beijing, China.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Yuan', 'Affiliation': 'Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Chinese Academy of Medical Sciences Research Unit (No.2018RU006), Peking University, Beijing, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Yao', 'Affiliation': 'Basic Medical College, Inner Mongolia Medical University, Hohhot, China.'}, {'ForeName': 'Sijing', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Faculty of Medicine, Department of Psychiatry, Chinese University of Hong Kong, Sha Tin, Hong Kong SAR, China.'}, {'ForeName': 'Jianyu', 'Initials': 'J', 'LastName': 'Que', 'Affiliation': 'Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Chinese Academy of Medical Sciences Research Unit (No.2018RU006), Peking University, Beijing, China.'}, {'ForeName': 'Yimiao', 'Initials': 'Y', 'LastName': 'Gong', 'Affiliation': 'Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Chinese Academy of Medical Sciences Research Unit (No.2018RU006), Peking University, Beijing, China.'}, {'ForeName': 'Yanping', 'Initials': 'Y', 'LastName': 'Bao', 'Affiliation': 'National Institute on Drug Dependence and Beijing Key Laboratory on Drug Dependence Research, Peking University, Beijing, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Shi', 'Affiliation': 'National Institute on Drug Dependence and Beijing Key Laboratory on Drug Dependence Research, Peking University, Beijing, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Han', 'Affiliation': 'National Institute on Drug Dependence and Beijing Key Laboratory on Drug Dependence Research, Peking University, Beijing, China. yinghan@bjmu.edu.cn.'}, {'ForeName': 'Hongqiang', 'Initials': 'H', 'LastName': 'Sun', 'Affiliation': 'Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Chinese Academy of Medical Sciences Research Unit (No.2018RU006), Peking University, Beijing, China. sunhq@bjmu.edu.cn.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Lu', 'Affiliation': 'Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Chinese Academy of Medical Sciences Research Unit (No.2018RU006), Peking University, Beijing, China. linlu@bjmu.edu.cn.'}]",Translational psychiatry,['10.1038/s41398-020-01023-w']
3379,33051487,Prostate cancer risk prediction using a polygenic risk score.,"Hereditary factors have a strong influence on prostate cancer (PC) risk and poorer outcomes, thus stratification by genetic factors addresses a critical need for targeted PC screening and risk-adapted follow-up. In this Finnish population-based retrospective study 2283 clinically diagnosed and 455 screen-detected patients from the Finnish Randomised Study of Screening for Prostate Cancer (FinRSPC), 2400 healthy individuals have been involved. Individual genetic risk through establishment of a polygenic risk score based on 55 PC risk SNPs identified through the Finnish subset of the Collaborative Oncological Gene-Environment Study was assessed. Men with PC had significantly higher median polygenic risk score compared to the controls (6.59 vs. 3.83, P < 0.0001). The polygenic risk score above the control median was a significant predictor of PC (OR 2.13, 95% CI 1.90-2.39). The polygenic risk score predicted the risk of PC with an AUC of 0.618 (95% CI 0.60-0.63). Men in the highest polygenic risk score quartile were 2.8-fold (95% CI 2.4-3.30) more likely to develop PC compared with men in the lowest quartile. In the FinRSPC cohort, a significantly higher percentage of men had a PSA level of ≥ 4 ng/mL in polygenic risk score quartile four compared to quartile one (18.7% vs 8.3%, P < 0.00001). Adding the PRS to a PSA-only model contributed additional information in predicting PC in the FinRSPC model. Results strongly suggest that use of the polygenic risk score would facilitate the identification of men at increased risk for PC.",2020,The polygenic risk score predicted the risk of PC with an AUC of 0.618 (95% CI 0.60-0.63).,"['Finnish population-based retrospective study 2283 clinically diagnosed and 455 screen-detected patients from the Finnish Randomised Study of Screening for Prostate Cancer (FinRSPC), 2400 healthy individuals have been involved']",[],"['highest polygenic risk score quartile', 'polygenic risk score quartile', 'median polygenic risk score', 'PSA level of\u2009≥', 'polygenic risk score', 'PC (OR']","[{'cui': 'C0016134', 'cui_str': 'Finnish language'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0035363', 'cui_str': 'Retrospective Study'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C4517656', 'cui_str': '2400'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}]",[],"[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}]",2400.0,0.0680311,The polygenic risk score predicted the risk of PC with an AUC of 0.618 (95% CI 0.60-0.63).,"[{'ForeName': 'Csilla', 'Initials': 'C', 'LastName': 'Sipeky', 'Affiliation': 'Institute of Biomedicine, University of Turku, Kiinamyllynkatu 10, 20520, Turku, Finland.'}, {'ForeName': 'Kirsi M', 'Initials': 'KM', 'LastName': 'Talala', 'Affiliation': 'Finnish Cancer Registry, Mass Screening Registry, Helsinki, Finland.'}, {'ForeName': 'Teuvo L J', 'Initials': 'TLJ', 'LastName': 'Tammela', 'Affiliation': 'Department of Urology, Tampere University Hospital and Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland.'}, {'ForeName': 'Kimmo', 'Initials': 'K', 'LastName': 'Taari', 'Affiliation': 'Department of Urology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Anssi', 'Initials': 'A', 'LastName': 'Auvinen', 'Affiliation': 'Unit of Health Sciences, Faculty of Social Sciences, Tampere University, Tampere, Finland.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Schleutker', 'Affiliation': 'Institute of Biomedicine, University of Turku, Kiinamyllynkatu 10, 20520, Turku, Finland. johanna.schleutker@utu.fi.'}]",Scientific reports,['10.1038/s41598-020-74172-z']
3380,33052289,Does Deep Neuromuscular Blockade Improve Operating Conditions during Minimally Invasive Anterolateral Total Hip Replacements?: A Randomized Controlled Trial.,"Background Neuromuscular blockade (NMB) is thought to improve operative conditions during certain procedures. Published descriptions of minimally invasive hip replacement techniques specify the need for ""excellent relaxation"", however, the optimal degree of NMB required for such cases has not been studied. We performed a randomized, single-blind study comparing the effect of moderate and deep neuromuscular blockade on surgical conditions and operating time during minimally invasive anterolateral hip replacement. Vecuronium was administered to maintain moderate NMB (train-of-four count of 1-2) or deep NMB (train-of-four count of 0, post-tetanic count of 1-2). Methods In this study, 116 patients were randomized to receive moderate or deep neuromuscular blockade; depth of blockade was monitored using acceleromyography. The primary outcome was the number of requests from the surgeon for additional blockade intraoperatively. Secondary outcomes included operative times and assessment of the operative conditions by the surgeon utilizing the Leiden-Surgical Rating Scale. Results Cases with additional requests for blockade did not differ between the deep and moderate NMB groups (11/58, 19.0% vs 8/58, 13.8%); relative risk, 1.22 (95% CI [confidence interval], 0.70-2.15), p=0.62. Neither time from incision to prosthesis reduction (33.8±1.2 min vs. 32.6 ±1.2 min; difference in geometric mean, 0.96 [95% CI, 0.90-1.04] minutes, p=0.33), nor the surgeon's assessment of operative conditions (p=0.88), differed between the deep or moderate NMB groups, respectively.  Conclusions Deep NMB did not produce significantly improved operative conditions compared with moderate NMB. Routine use of deep NMB during minimally invasive anterolateral hip arthroplasty is not supported by this study.",2020,"Results Cases with additional requests for blockade did not differ between the deep and moderate NMB groups (11/58, 19.0% vs 8/58, 13.8%); relative risk, 1.22 (95% CI [confidence interval], 0.70-2.15), p=0.62.","['minimally invasive anterolateral hip replacement', '116 patients']","['Vecuronium', 'moderate or deep neuromuscular blockade; depth of blockade was monitored using acceleromyography', ' Neuromuscular blockade (NMB', 'moderate and deep neuromuscular blockade', 'deep NMB']","['operative times and assessment of the operative conditions by the surgeon utilizing the Leiden-Surgical Rating Scale', 'surgical conditions and operating time', 'number of requests from the surgeon for additional blockade intraoperatively', 'time from incision to prosthesis reduction', 'operative conditions', ""surgeon's assessment of operative conditions""]","[{'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0332194', 'cui_str': 'Anterolateral'}, {'cui': 'C0392806', 'cui_str': 'Insertion of hip prosthesis'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0242531', 'cui_str': 'Vecuronium'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0234119', 'cui_str': 'Neuromuscular blockade'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C3805242', 'cui_str': 'Acceleromyography'}]","[{'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",116.0,0.190916,"Results Cases with additional requests for blockade did not differ between the deep and moderate NMB groups (11/58, 19.0% vs 8/58, 13.8%); relative risk, 1.22 (95% CI [confidence interval], 0.70-2.15), p=0.62.","[{'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Curry', 'Affiliation': 'Anesthesiology and Perioperative Medicine, Maine Medical Center, Portland, USA.'}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Steen', 'Affiliation': 'Anesthesiology and Perioperative Medicine, Maine Medical Center, Portland, USA.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Craig', 'Affiliation': 'Center for Outcomes Research and Evaluation, Maine Medical Center Research Institute, Portland, USA.'}, {'ForeName': 'Christopher W', 'Initials': 'CW', 'LastName': 'Cary', 'Affiliation': 'Anesthesiology and Perioperative Medicine, Maine Medical Center, Portland, USA.'}, {'ForeName': 'Janelle', 'Initials': 'J', 'LastName': 'Richard', 'Affiliation': 'Anesthesiology and Perioperative Medicine, Maine Medical Center, Portland, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Babikian', 'Affiliation': 'Orthopaedic Surgery, Maine Medical Center, Portland, USA.'}]",Cureus,['10.7759/cureus.10328']
3381,33052382,Effect of Risankizumab on Patient-Reported Outcomes in Moderate to Severe Psoriasis: The UltIMMa-1 and UltIMMa-2 Randomized Clinical Trials.,"Importance


Demonstrating the value of therapies from a patient's perspective is increasingly important for patient-centered care.
Objective


To compare patient-reported outcomes (PROs) with risankizumab vs ustekinumab and placebo in psoriasis symptoms, health-related quality of life (HRQL), and mental health among patients with moderate to severe psoriasis.
Design, Setting, and Participants


The UltIMMa-1 and UltIMMa-2 studies were replicate 52-week phase 3, randomized, multisite, double-blind, placebo-controlled and active comparator-controlled trials conducted in 139 sites (including hospitals, academic medical centers, clinical research units, and private practices) globally in Asia-Pacific, Japan, Europe, and North America. Adults (≥18 years) with moderate to severe chronic plaque psoriasis with body surface area (BSA) involvement of 10% or more, Psoriasis Area Severity Index (PASI) scores of 12 or higher, and static Physician's Global Assessment (sPGA) scores of 3 or higher were included.
Interventions


In each trial, patients were randomly assigned (3:1:1) to 150 mg of risankizumab, 45 mg or 90 mg of ustekinumab (weight-based per label) for 52 weeks, or matching placebo for 16 weeks followed by risankizumab.
Main Outcomes and Measures


Integrated data from 2 trials were used to compare Psoriasis Symptom Scale (PSS) (total score and item scores for pain, redness, itchiness, and burning), Dermatology Life Quality Index (DLQI), 5-level EuroQoL-5D (EQ-5D-5L), and Hospital Anxiety and Depression Scale (HADS), at baseline, week 16, and week 52.
Results


A total of 997 patients with moderate to severe chronic plaque psoriasis were analyzed. Across all arms, the mean age was 47.2 to 47.8 years and 68.3% (136/199 for ustekinumab) to 73.0% (146/200 for placebo) were men. Patients' characteristics and PROs were comparable across all treatment arms at baseline (n = 598, 199, 200 for risankizumab, ustekinumab, and placebo, respectively). At week 16, a significantly greater proportion of patients treated with risankizumab than those treated with ustekinumab or placebo achieved PSS = 0, indicating no psoriasis symptoms (30.3% [181/598], 15.1% [30/199], 1.0% [2/200], both P < .001), and DLQI = 0 or 1 indicating no impact on skin-related HRQL (66.2%, 44.7%, 6.0%, P < .001). Significantly greater proportions of patients treated with risankizumab achieved minimally clinically important difference (MCID) than ustekinumab or placebo for DLQI (94.5% [516/546], 85.1% [149/175], 35.6% [64/180]; both P < .001), EQ-5D-5L (41.7% [249/597] vs 31.5% [62/197], P = .01; vs 19.0% [38/200], P < .001), and HADS (anxiety: 69.1% [381/551] vs 57.1% [104/182], P = .004; vs 35.9% [66/184], P < .001; depression: 71.1% [354/598] vs 60.4% [96/159], P = .01; vs 37.1% [59/159], P < .001). At week 52, improvements in patients treated with risankizumab compared with those treated with ustekinumab were sustained for PSS, DLQI, and EQ-5D-5L.
Conclusions and Relevance


Risankizumab significantly improved symptoms of moderate to severe psoriasis, improved HRQL, and reduced psychological distress compared with ustekinumab or placebo.
Trial Registration


ClinicalTrials.gov Identifiers: NCT02684370 (UltIMMa-1) and NCT02684357 (UltIMMa-2).",2020,"Patients' characteristics and PROs were comparable across all treatment arms at baseline (n = 598, 199, 200 for risankizumab, ustekinumab, and placebo, respectively).","['Adults (≥18 years) with moderate to severe chronic plaque psoriasis with body surface area (BSA) involvement of 10% or more', 'patients with moderate to severe psoriasis', 'Moderate to Severe Psoriasis', 'controlled and active comparator-controlled trials conducted in 139 sites (including hospitals, academic medical centers, clinical research units, and private practices) globally in Asia-Pacific, Japan, Europe, and North America', 'mean age was 47.2 to 47.8 years and 68.3% (136/199 for ustekinumab) to 73.0% (146/200 for', '997 patients with moderate to severe chronic plaque psoriasis']","['risankizumab', 'risankizumab, 45 mg or 90 mg of ustekinumab (weight-based per label) for 52 weeks, or matching placebo', 'placebo', 'Risankizumab', 'ustekinumab or placebo', 'risankizumab vs ustekinumab and placebo']","['symptoms of moderate to severe psoriasis, improved HRQL, and reduced psychological distress', 'psoriasis symptoms, health-related quality of life (HRQL), and mental health', 'Psoriasis Symptom Scale (PSS) (total score and item scores for pain, redness, itchiness, and burning), Dermatology Life Quality Index (DLQI), 5-level EuroQoL-5D (EQ-5D-5L), and Hospital Anxiety and Depression Scale (HADS', 'EQ-5D-5L', 'psoriasis symptoms', "" Psoriasis Area Severity Index (PASI) scores of 12 or higher, and static Physician's Global Assessment (sPGA) scores"", 'skin-related HRQL']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0406317', 'cui_str': 'Chronic small plaque psoriasis'}, {'cui': 'C0005902', 'cui_str': 'Body surface area'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0033174', 'cui_str': 'Private Practice'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1608841', 'cui_str': 'ustekinumab'}]","[{'cui': 'C4505511', 'cui_str': 'risankizumab'}, {'cui': 'C1608841', 'cui_str': 'ustekinumab'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0559741', 'cui_str': 'Item score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0451112', 'cui_str': 'Dermatology life quality index'}, {'cui': 'C0456951', 'cui_str': 'Level 5'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C4324362', 'cui_str': 'Psoriasis area severity index'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}]",997.0,0.501421,"Patients' characteristics and PROs were comparable across all treatment arms at baseline (n = 598, 199, 200 for risankizumab, ustekinumab, and placebo, respectively).","[{'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Augustin', 'Affiliation': 'University Medical Center Hamburg, Hamburg, Germany.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Lambert', 'Affiliation': 'Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Zema', 'Affiliation': 'Formerly AbbVie Inc, North Chicago, Illinois.'}, {'ForeName': 'Elizabeth H Z', 'Initials': 'EHZ', 'LastName': 'Thompson', 'Affiliation': 'Formerly AbbVie Inc, North Chicago, Illinois.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Yang', 'Affiliation': 'Analysis Group, Inc, Boston, Massachusetts.'}, {'ForeName': 'Eric Q', 'Initials': 'EQ', 'LastName': 'Wu', 'Affiliation': 'Analysis Group, Inc, Boston, Massachusetts.'}, {'ForeName': 'Viviana', 'Initials': 'V', 'LastName': 'Garcia-Horton', 'Affiliation': 'Analysis Group, Inc, New York, New York.'}, {'ForeName': 'Ziqian', 'Initials': 'Z', 'LastName': 'Geng', 'Affiliation': 'AbbVie Inc, North Chicago, Illinois.'}, {'ForeName': 'Joaquin M', 'Initials': 'JM', 'LastName': 'Valdes', 'Affiliation': 'Formerly AbbVie Inc, North Chicago, Illinois.'}, {'ForeName': 'Avani', 'Initials': 'A', 'LastName': 'Joshi', 'Affiliation': 'AbbVie Inc, North Chicago, Illinois.'}, {'ForeName': 'Kenneth B', 'Initials': 'KB', 'LastName': 'Gordon', 'Affiliation': 'Medical College of Wisconsin, Milwaukee.'}]",JAMA dermatology,['10.1001/jamadermatol.2020.3617']
3382,33052400,Effect of Tropisetron on Prevention of Emergence Delirium in Patients After Noncardiac Surgery: A Trial Protocol.,"Importance


Postoperative delirium is a frequent disorder for patients undergoing surgery and is associated with poor outcomes. Delirium may occur in the immediate period after anesthesia administration and surgery. Tropisetron, which is frequently administrated for postoperative nausea and vomiting, is also a partial agonist of α7 nicotinic acetylcholine receptors associated with neuroprotective effects. Tropisetron may be the potential pharmacological treatment to decrease delirium after noncardiac surgery.
Objective


To perform a randomized clinical trial to determine the efficacy and safety of tropisetron for prevention of emergence delirium in patients undergoing noncardiac surgery.
Design, Setting, and Participants


This single-center, 2-arm randomized, double-blind, placebo-controlled trial will include 1508 patients undergoing noncardiac surgery. The intervention group will receive 5 mg of intravenous tropisetron before anesthesia induction, and patients in the control group will receive a placebo. The primary end point is the incidence of emergence delirium within 1 hour after tracheal tube removal, measured by the Confusion Assessment Method for the Intensive Care Unit score. The main secondary outcome is the incidence of postoperative delirium measured at 3 days of follow-up. An intention-to-treat principle will be used for all analyses.
Discussion


Delirium remains the most common neuropsychiatric complication for patients after surgery. This will be the first randomized clinical study to evaluate whether tropisetron is effective in preventing emergence delirium. Results from this study will provide evidence for alteration of daily practice.
Trial Registration


ClinicalTrials.gov Identifier: NCT04027751.",2020,"Tropisetron, which is frequently administrated for postoperative nausea and vomiting, is also a partial agonist of α7 nicotinic acetylcholine receptors associated with neuroprotective effects.","['patients after surgery', 'patients undergoing surgery', 'Patients', '1508 patients undergoing noncardiac surgery', 'patients undergoing noncardiac surgery']","['Tropisetron', 'placebo', 'tropisetron']","['incidence of postoperative delirium', 'efficacy and safety', 'Emergence Delirium', 'incidence of emergence delirium within 1 hour after tracheal tube removal, measured by the Confusion Assessment Method for the Intensive Care Unit score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0063322', 'cui_str': 'tropisetron'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C4721772', 'cui_str': 'Postoperative delirium'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0920253', 'cui_str': 'Agitated Emergence'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C1260970', 'cui_str': 'Tracheal tube'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0009676', 'cui_str': 'Confusional state'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",1508.0,0.696369,"Tropisetron, which is frequently administrated for postoperative nausea and vomiting, is also a partial agonist of α7 nicotinic acetylcholine receptors associated with neuroprotective effects.","[{'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Department of Anesthesiology, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Dandan', 'Initials': 'D', 'LastName': 'Lin', 'Affiliation': 'Department of Anesthesiology, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Mengwen', 'Initials': 'M', 'LastName': 'Geng', 'Affiliation': 'Department of Anesthesiology, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Xue', 'Affiliation': 'Department of Anesthesiology, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yayun', 'Initials': 'Y', 'LastName': 'Lang', 'Affiliation': 'Department of Anesthesiology, Beijing Civil Aviation General Hospital, Beijing, China.'}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Cui', 'Affiliation': 'Department of Anesthesiology, Beijing Huairou District Hospital of Traditional Chinese Medicine, Beijing, China.'}, {'ForeName': 'Yanan', 'Initials': 'Y', 'LastName': 'Hao', 'Affiliation': 'Department of Anesthesiology, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Shanshan', 'Initials': 'S', 'LastName': 'Mu', 'Affiliation': 'Department of Anesthesiology, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': 'Department of Anesthesiology, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Lirong', 'Initials': 'L', 'LastName': 'Liang', 'Affiliation': 'Department of Clinical Epidemiology and Tobacco Dependence Treatment Research, Beijing Chao-Yang Hospital, Capital Medical University, Beijing Institute of Respiratory Medicine, Beijing, China.'}, {'ForeName': 'Anshi', 'Initials': 'A', 'LastName': 'Wu', 'Affiliation': 'Department of Anesthesiology, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA network open,['10.1001/jamanetworkopen.2020.13443']
3383,33052404,Feasibility and Efficacy of a Resiliency Intervention for the Prevention of Chronic Emotional Distress Among Survivor-Caregiver Dyads Admitted to the Neuroscience Intensive Care Unit: A Randomized Clinical Trial.,"Importance


To our knowledge, there are no evidence-based interventions to prevent chronic emotional distress (ie, depression, anxiety, and posttraumatic stress [PTS]) in critical care survivors and their informal caregivers.
Objective


To determine the feasibility and preliminary effect of the novel dyadic resiliency intervention Recovering Together (RT) on reducing symptoms of depression, anxiety, and PTS among hospitalized patients and their informal caregivers.
Design, Setting, and Participants


This single-blind, pilot randomized clinical trial of RT vs an educational control was conducted among 58 dyads in which either the survivor or caregiver endorsed clinically significant symptoms of depression, anxiety, or PTS. The study was conducted in the neuroscience intensive care unit at Massachusetts General Hospital. Data were collected from September 2019 to March 2020.
Interventions


Both RT and control programs had 6 sessions (2 at bedside and 4 via live video after discharge), and both survivor and caregiver participated together.
Main Outcomes and Measures


The primary outcomes were feasibility of recruitment and intervention delivery, credibility, and satisfaction. The secondary outcomes included depression and anxiety (measured by the Hospital Depression and Anxiety Scale), PTS (measured by the PTSD Checklist-Civilian Version), and intervention targets (ie, mindfulness, measured by the Cognitive and Affective Mindfulness Scale-Revised; coping, measured by the Measure of Current Status-Part A; and dyadic interpersonal interactions, measured by the Dyadic Relationship Scale). Main outcomes and targets were assessed at baseline, 6 weeks, and 12 weeks.
Results


The 58 dyads were randomized to RT (29 dyads [50.0%]; survivors: mean [SD] age, 49.3 [16.7] years; 9 [31.0%] women; caregivers: mean [SD] age, 52.4 [14.3] years; 22 [75.9%] women) or control (29 dyads [50.0%]; survivors: mean [SD] age, 50.3 [16.4] years; 12 [41.3%] women; caregivers, mean [SD] age, 52.1 [14.9], 17 [58.6%] women). Feasibility (recruitment [76%], randomization [100%], and data collection [83%-100%]), adherence (86%), fidelity (100%; κ = 0.98), satisfaction (RT: 57 of 58 [98%] with scores >6; control: 58 of 58 [100%] with scores >6), credibility (RT: 47 of 58 [81%] with scores >6; control: 46 of 58 [80%] with scores >6), and expectancy (RT: 49 of 58 [85%] with scores >13.5; 51 of 58 [87%] with scores >13.5) exceeded benchmarks set a priori. Participation in RT was associated with statistically and clinically significant improvement between baseline and postintervention in symptoms of depression (among survivors: -4.0 vs -0.6; difference, -3.4; 95% CI, -5.6 to -1.3; P = .002; among caregivers: -3.8 vs 0.6; difference, -4.5; 95% CI, -6.7 to -2.3; P < .001), anxiety (among survivors: -6.0 vs 0.3; difference, -6.3; 95% CI, -8.8 to -3.8; P < .001; among caregivers: -5.0 vs -0.9; difference, -4.1; 95% CI, -6.7 to -1.5, P = .002), and PTS (among survivors: -11.3 vs 1.0; difference, -12.3; 95% CI, -18.1 to -6.5, P < .001; among caregivers, -11.4 vs 5.0; difference, -16.4, 95% CI, -21.8 to -10.9; P < .001). Improvements sustained through the 12-week follow-up visit. We also observed RT-dependent improvement in dyadic interpersonal interactions for survivors (0.2 vs -0.2; difference, 0.4; 95% CI, 0.0 to 0.8; P = .04).
Conclusions and Relevance


In this pilot randomized clinical trial, RT was feasible and potentially efficacious in preventing chronic emotional distress in dyads of survivors of the neuroscience intensive care unit and their informal caregivers.
Trial Registration


ClinicalTrials.gov Identifier: NCT03694678.",2020,"In this pilot randomized clinical trial, RT was feasible and potentially efficacious in preventing chronic emotional distress in dyads of survivors of the neuroscience intensive care unit and their informal caregivers.
","['dyads of survivors of the neuroscience intensive care unit and their informal caregivers', 'Survivor-Caregiver Dyads Admitted to the Neuroscience Intensive Care Unit', 'hospitalized patients and their informal caregivers', '58 dyads were randomized to RT (29 dyads [50.0%]; survivors: mean [SD] age, 49.3 [16.7] years; 9 [31.0%] women; caregivers: mean [SD] age, 52.4 [14.3] years; 22 [75.9%] women) or control (29 dyads [50.0%]; survivors: mean [SD] age, 50.3 [16.4] years; 12 [41.3%] women; caregivers, mean [SD] age, 52.1 [14.9], 17 [58.6%] women', '58 dyads in which either the survivor or caregiver endorsed clinically significant symptoms of depression, anxiety, or PTS', 'neuroscience intensive care unit at Massachusetts General Hospital']","['Resiliency Intervention', 'RT', 'novel dyadic resiliency intervention Recovering Together (RT']","['fidelity', 'feasibility of recruitment and intervention delivery, credibility, and satisfaction', 'depression and anxiety (measured by the Hospital Depression and Anxiety Scale), PTS (measured by the PTSD Checklist-Civilian Version), and intervention targets (ie, mindfulness, measured by the Cognitive and Affective Mindfulness Scale-Revised; coping, measured by the Measure of Current Status-Part A; and dyadic interpersonal interactions, measured by the Dyadic Relationship Scale', 'adherence', 'symptoms of depression', 'Feasibility and Efficacy', 'chronic emotional distress', 'Chronic Emotional Distress', 'dyadic interpersonal interactions', 'symptoms of depression, anxiety, and PTS', 'anxiety']","[{'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0027910', 'cui_str': 'Neurosciences'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C1319882', 'cui_str': 'Informal caregiver'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517590', 'cui_str': '16.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517770', 'cui_str': '41.3'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0205314', 'cui_str': 'New'}]","[{'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0700361', 'cui_str': 'Emotional distress'}]",58.0,0.167253,"In this pilot randomized clinical trial, RT was feasible and potentially efficacious in preventing chronic emotional distress in dyads of survivors of the neuroscience intensive care unit and their informal caregivers.
","[{'ForeName': 'Ana-Maria', 'Initials': 'AM', 'LastName': 'Vranceanu', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Bannon', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Mace', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Ethan', 'Initials': 'E', 'LastName': 'Lester', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Meyers', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Gates', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Popok', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Lin', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Salgueiro', 'Affiliation': 'Neuroscience Intensive Care Unit, Massachusetts General Hospital, Boston.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Tehan', 'Affiliation': 'Neuroscience Intensive Care Unit, Massachusetts General Hospital, Boston.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Macklin', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Rosand', 'Affiliation': 'Henry and Allison McCance Center for Brain Health, Massachusetts General Hospital, Boston.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.20807']
3384,33061256,"Overnight Safety Evaluation of a Multi-Pressure Dial in Eyes with Glaucoma: Prospective, Open-Label, Randomized Study.","Purpose


To investigate the safety and tolerability of the multi-pressure dial (MPD) worn overnight for seven consecutive days.
Design


Prospective, open-label, randomized, single-site study.
Subjects


Twenty eyes of 10 subjects with open-angle glaucoma were fitted with an MPD and randomized to negative pressure application of -10 mmHg in one eye (study eye) worn overnight for 7 consecutive days.
Methods


Safety measures included best-corrected visual acuity (BCVA), intraocular pressure (IOP) changes from baseline during and after negative pressure application, slit lamp and dilated fundus exam findings, and rate of adverse events. Subjective assessments were completed daily by the subjects during the 7-day study period and immediately following the study period.
Results


Prior to the 7-day testing period, application of 10 mmHg negative pressure reduced mean IOP from 18.2 ± 3.8 mmHg to 14.0 ± 2.1 mmHg (p<0.01), a 22% reduction. After 7 days of consecutive nightly wear, repeat IOP measurements with the application of negative pressure showed a decrease in mean IOP from 16.9 ± 4.3 mmHg to 13.5 ± 3.7 mmHg. The observed IOP reduction was in addition to the subjects' current treatment regimen. There were no statistically significant changes in IOP, BCVA from baseline following the 7-day period of nightly wear with the application of negative pressure. The patient-reported outcomes were favorable.
Conclusion


The MPD can safely and comfortably be worn overnight. The decrease in IOP of >20% in addition to current therapy is both clinically and statistically significant. The MPD shows promise as a potential new treatment option for nocturnal IOP control.",2020,"There were no statistically significant changes in IOP, BCVA from baseline following the 7-day period of nightly wear with the application of negative pressure.","['Subjects\n\n\nTwenty eyes of 10 subjects with open-angle glaucoma', 'Eyes with Glaucoma', 'seven consecutive days']","['multi-pressure dial (MPD', 'Multi-Pressure Dial', 'MPD and randomized to negative pressure application of -10 mmHg in one eye (study eye) worn overnight for 7 consecutive days']","['safety and tolerability', 'IOP, BCVA', 'corrected visual acuity (BCVA), intraocular pressure (IOP) changes from baseline during and after negative pressure application, slit lamp and dilated fundus exam findings, and rate of adverse events', 'IOP reduction', 'IOP']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0017612', 'cui_str': 'Open-angle glaucoma'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439583', 'cui_str': 'Overnight'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0183355', 'cui_str': 'Slit lamp biomicroscope'}, {'cui': 'C0700124', 'cui_str': 'Ectatic'}, {'cui': 'C0016823', 'cui_str': 'Structure of fundus of eye'}, {'cui': 'C0582103', 'cui_str': 'Medical assessment'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",10.0,0.0254859,"There were no statistically significant changes in IOP, BCVA from baseline following the 7-day period of nightly wear with the application of negative pressure.","[{'ForeName': 'Tanner J', 'Initials': 'TJ', 'LastName': 'Ferguson', 'Affiliation': 'Cole Eye Institute, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Nathan M', 'Initials': 'NM', 'LastName': 'Radcliffe', 'Affiliation': 'New York Eye and Ear Infirmary of Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Sarah H', 'Initials': 'SH', 'LastName': 'Van Tassel', 'Affiliation': 'Department of Ophthalmology, Weill Cornell Medicine, New York, NY, USA.'}, {'ForeName': 'Brandon J', 'Initials': 'BJ', 'LastName': 'Baartman', 'Affiliation': 'Vance Thompson Vision, Sioux Falls, SD, USA.'}, {'ForeName': 'Vance M', 'Initials': 'VM', 'LastName': 'Thompson', 'Affiliation': 'Vance Thompson Vision, Sioux Falls, SD, USA.'}, {'ForeName': 'Richard L', 'Initials': 'RL', 'LastName': 'Lindstrom', 'Affiliation': 'Vance Thompson Vision, Sioux Falls, SD, USA.'}, {'ForeName': 'Mitch J', 'Initials': 'MJ', 'LastName': 'Ibach', 'Affiliation': 'Vance Thompson Vision, Sioux Falls, SD, USA.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Berdahl', 'Affiliation': 'Vance Thompson Vision, Sioux Falls, SD, USA.'}]","Clinical ophthalmology (Auckland, N.Z.)",['10.2147/OPTH.S256891']
3385,33061274,Comparison of Subjective Preoperative Experiences of Patients Before First- or Second-Eye Cataract Surgeries.,"Purpose


To compare the subjective preoperative experiences of patients undergoing their first- or second-cataract surgeries.
Patients and Methods


Consecutive patients undergoing phacoemulsification were asked to complete postoperative questionnaires evaluating their subjective preoperative experiences, including their emotional state, decision-making process, and opinions on the admission and examination processes, medical interviews, and quality of service. The obtained data were compared between patients undergoing their first (group I)- or second (group II)-cataract surgeries.
Results


Two hundred patients (group I, 124; group II, 76) were included in the evaluation. Presurgical anxiety was more prevalent in group I than in group II (55.7% vs 34.2%,  P  = 0.005). Fear was the major trigger for reconsidering the decision to undergo surgery, with 29% and 13.2% of patients in groups I and II, respectively, considering abandoning the operation ( P  = 0.016). The preoperative medical examination was reported to be sufficiently accurate by 66.1% and 80.3% of patients in groups I and II, respectively ( P  = 0.047), while 28.2% and 21% of patients in groups I and II, respectively, did not understand the information presented about possible complications of surgery ( P  = 0.039). Administration of eyedrops before surgery was uncomfortable for 71.4% and 68.4% of patients in groups I and II, respectively ( P  = 0.553), while 22.6% and 9.2% of patients in groups I and II, respectively, found repeated administration of drops to be highly uncomfortable (P = 0.026).
Conclusion


Patients experienced greater anxiety before their first-cataract surgery than before their second-cataract surgery. Moreover, many patients from both groups did not understand the medical information provided by doctors regarding the surgery and its possible complications. The most unpleasant stage of preparation for cataract surgery was repeated administration of eyedrops.
Trial Registration


The study was registered on clinicaltrial.gov under the number NCT04327856.",2020,"Administration of eyedrops before surgery was uncomfortable for 71.4% and 68.4% of patients in groups I and II, respectively ( P  = 0.553), while 22.6% and 9.2% of patients in groups I and II, respectively, found repeated administration of drops to be highly uncomfortable (P = 0.026).
","['patients undergoing their first- or second-cataract surgeries', 'Patients Before First- or Second-Eye Cataract Surgeries', 'Two hundred patients (group I, 124; group II, 76) were included in the evaluation']",['eyedrops'],"['subjective preoperative experiences', 'preoperative medical examination', 'emotional state, decision-making process, and opinions on the admission and examination processes, medical interviews, and quality of service', 'Presurgical anxiety', 'anxiety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0441843', 'cui_str': 'Group I'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}]","[{'cui': 'C0015399', 'cui_str': 'Eye drops'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0582103', 'cui_str': 'Medical assessment'}, {'cui': 'C0684322', 'cui_str': 'Emotional state finding'}, {'cui': 'C0011109', 'cui_str': 'Decision making'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0034030', 'cui_str': 'Public Opinion'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",200.0,0.0214365,"Administration of eyedrops before surgery was uncomfortable for 71.4% and 68.4% of patients in groups I and II, respectively ( P  = 0.553), while 22.6% and 9.2% of patients in groups I and II, respectively, found repeated administration of drops to be highly uncomfortable (P = 0.026).
","[{'ForeName': 'Dorota', 'Initials': 'D', 'LastName': 'Ługowska', 'Affiliation': 'Department of Ophthalmology, Medical University of Bialystok, Bialystok 15-276, Poland.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Konopinska', 'Affiliation': 'Department of Ophthalmology, Medical University of Bialystok, Bialystok 15-276, Poland.'}, {'ForeName': 'Zofia', 'Initials': 'Z', 'LastName': 'Mariak', 'Affiliation': 'Department of Ophthalmology, Medical University of Bialystok, Bialystok 15-276, Poland.'}, {'ForeName': 'Iwona', 'Initials': 'I', 'LastName': 'Obuchowska', 'Affiliation': 'Department of Ophthalmology, Medical University of Bialystok, Bialystok 15-276, Poland.'}]","Clinical ophthalmology (Auckland, N.Z.)",['10.2147/OPTH.S270196']
3386,33061275,The Efficacy Between Conventional Lid Hygiene and Additional Thermal Pulsatile System in Meibomian Gland Dysfunction Patients Treated with Long-Term Anti-Glaucoma Medications in a Randomized Controlled Trial.,"Purpose


To evaluate the efficacy of additional thermal pulsatile system compared to standard lid hygiene alone in meibomian gland dysfunction (MGD) patients who are using long-term anti-glaucoma medications.
Patients and Methods


Well-controlled glaucoma patients who used anti-glaucoma medications for at least 1 year and had MGD were enrolled and randomized between a study group who received thermal pulsatile system (Lipiflow ® ) treatment and standard lid hygiene, and a control group who received standard lid hygiene alone. The primary outcome was meibomian gland expression score, and the secondary outcomes were the Ocular Surface Disease Index (OSDI) score, Schirmer test score, tear break-up time (TBUT), corneal staining score, lipid layer thickness (LLT), and meibography score. All the outcomes were re-evaluated at 1 week, then at 1, 3, and 6 months after treatment.
Results


Of 60 participants who underwent randomization, 48 completed the study. At the 6-month mark, this study could not demonstrate any significant difference between groups in both primary and secondary outcomes. However, there was significant improvement from baseline in both groups of the following outcomes: meibomian gland expression score, OSDI score, LLT, and meibography score. No serious adverse event was found in this study.
Conclusion


An additional single thermal pulsatile system treatment with standard lid hygiene significantly improved meibomian gland assessment score and subjective symptoms at 6 months. Any difference between additional thermal pulsatile system treatment and lid hygiene alone was not found in this study. The results may suggest more chronic MGD and more damaged meibomian gland induced by long-term anti-glaucoma medications.",2020,"At the 6-month mark, this study could not demonstrate any significant difference between groups in both primary and secondary outcomes.","['Patients and Methods\n\n\nWell-controlled glaucoma patients who used anti-glaucoma medications for at least 1 year and had MGD', 'meibomian gland dysfunction (MGD) patients who are using long-term anti-glaucoma medications', 'Meibomian Gland Dysfunction Patients Treated with Long-Term Anti-Glaucoma Medications', '60 participants who underwent randomization, 48 completed the study']","['standard lid hygiene alone', 'Conventional Lid Hygiene and Additional Thermal Pulsatile System', 'thermal pulsatile system (Lipiflow ® ) treatment and standard lid hygiene, and a control group who received standard lid hygiene alone', 'additional thermal pulsatile system']","['meibomian gland assessment score and subjective symptoms', 'meibomian gland expression score', 'Ocular Surface Disease Index (OSDI) score, Schirmer test score, tear break-up time (TBUT), corneal staining score, lipid layer thickness (LLT), and meibography score', 'meibomian gland expression score, OSDI score, LLT, and meibography score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3853142', 'cui_str': 'Well controlled'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1275684', 'cui_str': 'Meibomian gland dysfunction'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0439606', 'cui_str': 'Pulsatile'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0025181', 'cui_str': 'Structure of meibomian gland'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1557335', 'cui_str': 'Ocular surface disease'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0200152', 'cui_str': ""Schirmer's test""}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0423232', 'cui_str': 'Corneal epithelial staining pattern'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C1280412', 'cui_str': 'Thick'}]",60.0,0.0803014,"At the 6-month mark, this study could not demonstrate any significant difference between groups in both primary and secondary outcomes.","[{'ForeName': 'Ngamjit', 'Initials': 'N', 'LastName': 'Kasetsuwan', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Bangkok 10330, Thailand.'}, {'ForeName': 'Disorn', 'Initials': 'D', 'LastName': 'Suwajanakorn', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Bangkok 10330, Thailand.'}, {'ForeName': 'Chitchanok', 'Initials': 'C', 'LastName': 'Tantipat', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Bangkok 10330, Thailand.'}, {'ForeName': 'Usanee', 'Initials': 'U', 'LastName': 'Reinprayoon', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Bangkok 10330, Thailand.'}]","Clinical ophthalmology (Auckland, N.Z.)",['10.2147/OPTH.S259692']
3387,33061276,Evaluation of Visual and Subjective Outcomes with Mix-and-Match of Three One-Piece Tecnis Multifocal IOLs of Varying Add Powers.,"Purpose


To evaluate visual and subjective outcomes after bilateral mix-and-match implantation of one-piece diffractive multifocal IOLs in different near add powers (+2.75 D, +3.25 D, +4.0 D).
Setting


Four US clinics.
Design


Prospective, multi-center, parallel comparison clinical study design.
Patients and Methods


Two treatment groups received implantation with either the +3.25 D (ZLB00) or the +4.00 D (ZMB00) Tecnis ®  Multifocal 1-piece IOL in their non-dominant eye, and the +2.75 D (ZKB00) Tecnis Multifocal 1-piece IOL in their dominant eye (Abbott Medical Optics, Inc., Santa Ana, CA). Each study patient underwent the same routine cataract extraction procedures for each eye, with the second eye scheduled to undergo cataract extraction within 7 to 30 days after the 1st eye surgery. Visual and subjective outcomes were evaluated at 90 days after 2nd eye surgery for the two groups: +3.25D/+2.75D (n=41) and +4.00D/+2.75D (n=36).
Results


Mean binocular uncorrected distance visual acuities at 90 days postop were 0.02 ± 0.082 (+3.25D/+2.75D) vs 0.07 ± 0.128 (+4.00D/+2.75D) (p=0.025). Mean binocular uncorrected intermediate visual acuities at 90 days postop were 0.14 ± 0.185 (+3.25D/+2.75D) vs 0.26 ± 0.261 (+4.00D/+2.75D) (p=0.024). Mean binocular uncorrected near visual acuities at 90 days postop were 0.06 ± 0.098 (+3.25D/+2.75D) vs 0.19 ± 0.286 (+4.00D/+2.75D) (p=0.018). Over 88% of patients reported ""none"" for visual symptoms of glare, halos, starburst, or other. Freedom from glasses or contacts was reported by groups +3.25D/+2.75D and +4.00D/+2.75D as follows: distance (95.1% vs 97.1%), intermediate (92.7% vs 94.1%), and near activities (82.9% vs 64.7%).
Conclusion


At 90 days postoperatively, both groups demonstrated good visual and subjective outcomes; however, differences in near and intermediate outcomes favored the +3.25/+2.75 IOL combination.
Clinicaltrialsgov Registration


NCT02863159 (08/11/2016).",2020,"At 90 days postoperatively, both groups demonstrated good visual and subjective outcomes; however, differences in near and intermediate outcomes favored the +3.25/+2.75 IOL combination.
","['Each study patient underwent the same routine cataract extraction procedures for each eye, with the second eye scheduled to undergo cataract extraction within 7 to 30 days after the 1st eye surgery']","['implantation with either the +3.25 D (ZLB00) or the +4.00 D (ZMB00) Tecnis ®  Multifocal 1-piece IOL in their non-dominant eye, and the +2.75 D (ZKB00']","['Mean binocular uncorrected near visual acuities', 'Mean binocular uncorrected distance visual acuities', 'Visual and subjective outcomes', 'Mean binocular uncorrected intermediate visual acuities', 'good visual and subjective outcomes']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205435', 'cui_str': 'First'}, {'cui': 'C0038901', 'cui_str': 'Ophthalmologic Surgical Procedure'}]","[{'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0205292', 'cui_str': 'Multifocal'}, {'cui': 'C0281658', 'cui_str': 'Intraocular Lymphoma'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C4517639', 'cui_str': '2.75'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2594855', 'cui_str': 'Binoculars'}, {'cui': 'C0429541', 'cui_str': 'Near visual acuity'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1690987', 'cui_str': 'Intermediate visual acuity'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}]",,0.0461146,"At 90 days postoperatively, both groups demonstrated good visual and subjective outcomes; however, differences in near and intermediate outcomes favored the +3.25/+2.75 IOL combination.
","[{'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Dell', 'Affiliation': 'Dell Laser Consultants, Austin, TX, USA.'}]","Clinical ophthalmology (Auckland, N.Z.)",['10.2147/OPTH.S266120']
3388,33061555,"Operation, Effectiveness, and Limitations of Continuous Serratus Anterior Plane Blocks for Thoracoscopic Surgery in Adults.","Purpose


This randomized, double-blind study evaluated the effectiveness and limitations of continuous serratus anterior plane block (cSAPB) by comparing the effect of cSAPB to patient-controlled intravenous analgesia (PCIA) on postoperative acute pain after thoracoscopic surgery in adults.
Patients and Methods


Sixty-six patients who underwent elective video-assisted thoracoscopic surgery (VATS) were randomly allocated to cSAPB or PCIA groups (n=33 per group) after surgery. For the cSAPB group, patients were treated by an initial does of 20 mL ropivacaine (0.375%), followed by continuous infusion at a rate of 5 mL/h of ropivacaine (0.2%) and a patient-controlled bolus of 5 mL ropivacaine (0.2%). PCIA started with an initial does of 0.03 µg/kg sufentanil, followed by a basal infusion of 0.03 µg/kg/h sufentanil and a patient-controlled bolus of 0.03 µg/kg sufentanil. Visual analog scale (VAS) and other items were examined postoperatively. The area under the curve of VAS-time (AUC VAS-time ) at rest and on coughing in the first 24 hours postoperatively were primary outcomes.
Results


At the first 24 hours postoperatively, patients in the cSAPB group exhibited a smaller AUC VAS-time  at rest (44.0±17.1 vs 68.9±11.8 cm·h,  P <0.001) and AUC VAS-time  on coughing (67.1±8.8 vs 78.0±12.5 cm·h,  P <0.001) compared with those in the PCIA group. The differences in means of VAS score at rest were more than 1.0 cm between the two groups, however, on coughing they were less than 1.0 cm at each observation point. Additionally, patients in the cSAPB group had a longer time to first patient-controlled bolus (15.8±7.6 vs 10.6±8.6 hours,  P =0.011). Furthermore, a higher rank of satisfaction was recorded with patients in the cSAPB group.
Conclusion


cSAPB using PCA devices might be superior to traditional intravenous continuous analgesia, particularly with an advantage of pain relief at rest following VATS operation. Meanwhile, cSAPB lacks a satisfactory analgesic effect on cough.",2020,"The differences in means of VAS score at rest were more than 1.0 cm between the two groups, however, on coughing they were less than 1.0 cm at each observation point.","['postoperative acute pain after thoracoscopic surgery in adults', 'Thoracoscopic Surgery in Adults', 'Patients and Methods\n\n\nSixty-six patients who underwent']","['continuous serratus anterior plane block (cSAPB', 'sufentanil', 'ropivacaine', 'cSAPB to patient-controlled intravenous analgesia (PCIA', 'cSAPB or PCIA', 'elective video-assisted thoracoscopic surgery (VATS']","['higher rank of satisfaction', 'AUC VAS-time  on coughing', 'VAS score', 'smaller AUC VAS-time  at rest', 'pain relief', 'longer time to first patient-controlled bolus', 'Visual analog scale (VAS', 'area under the curve of VAS-time (AUC VAS-time ) at rest and on coughing']","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0184567', 'cui_str': 'Acute pain'}, {'cui': 'C0751551', 'cui_str': 'Thoracoscopic Surgical Procedures'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4517841', 'cui_str': '66'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0224349', 'cui_str': 'Structure of serratus anterior muscle'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0752151', 'cui_str': 'Surgery, Thoracic, Video-Assisted'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0667477', 'cui_str': 'TNFRSF11A protein, human'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",66.0,0.0848936,"The differences in means of VAS score at rest were more than 1.0 cm between the two groups, however, on coughing they were less than 1.0 cm at each observation point.","[{'ForeName': 'Xin-Lu', 'Initials': 'XL', 'LastName': 'Yang', 'Affiliation': ""Department of Anesthesiology, Pain Clinic, First Affiliated Hospital, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Anhui, People's Republic of China.""}, {'ForeName': 'Hai', 'Initials': 'H', 'LastName': 'Gu', 'Affiliation': ""Department of Anesthesiology, Pain Clinic, First Affiliated Hospital, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Anhui, People's Republic of China.""}, {'ForeName': 'Ji-Cheng', 'Initials': 'JC', 'LastName': 'Hu', 'Affiliation': ""Department of Anesthesiology, Pain Clinic, First Affiliated Hospital, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Anhui, People's Republic of China.""}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': ""Department of Anesthesiology, Pain Clinic, First Affiliated Hospital, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Anhui, People's Republic of China.""}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Wei', 'Affiliation': ""Department of Anesthesiology, Pain Clinic, First Affiliated Hospital, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Anhui, People's Republic of China.""}, {'ForeName': 'Shu-Hua', 'Initials': 'SH', 'LastName': 'Shu', 'Affiliation': ""Department of Anesthesiology, Pain Clinic, First Affiliated Hospital, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Anhui, People's Republic of China.""}, {'ForeName': 'Wei-de', 'Initials': 'WD', 'LastName': 'Zhou', 'Affiliation': ""Department of Anesthesiology, Pain Clinic, First Affiliated Hospital, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Anhui, People's Republic of China.""}, {'ForeName': 'Chun-Rong', 'Initials': 'CR', 'LastName': 'Tao', 'Affiliation': ""Department of Neurology, First Affiliated Hospital, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Anhui, People's Republic of China.""}, {'ForeName': 'Di', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': ""Department of Anesthesiology, Pain Clinic, First Affiliated Hospital, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Anhui, People's Republic of China.""}, {'ForeName': 'Xiao-Qing', 'Initials': 'XQ', 'LastName': 'Chai', 'Affiliation': ""Department of Anesthesiology, Pain Clinic, First Affiliated Hospital, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Anhui, People's Republic of China.""}]",Journal of pain research,['10.2147/JPR.S264139']
3389,33054724,Precision implementation of early ambulation in elderly patients undergoing off-pump coronary artery bypass graft surgery: a randomized-controlled clinical trial.,"BACKGROUND


Although early ambulation (EA) is associated with improved outcomes in post-operative patients, implementation of EA in elderly patients is still a challenge. In this study, we aimed to design and assess a precision early ambulation program for cardiac rehabilitation.
METHODS


We conducted a single-center, randomized and controlled clinical trial in elderly patients aged over 60 years after off-pump coronary artery bypass graft (OPCABG) surgery. Patients were randomly assigned to a precision early ambulation (PEA) group or a routine ambulation (Control) group. Age-predicted maximal heart rate (APMHR) and maximal oxygen uptake (VO 2max)  were used as a reference to formulate and monitor the PEA regimen. The primary end-point was the postoperative length of stay in hospital (PLOS). The secondary end-points included 90-day mortality, incidence of early discharge, laboratory tests, length of ICU stay, the incidence of multiple organ complications and post-traumatic stress disorder (PTSD). Ambulation outcomes were also recorded.
RESULTS


In total, 178 patients were enrolled (n = 89 per group). In the intent-to-treat analysis, PLOS in the PEA group was shorter than that in the Control group (9.04 ± 3.08 versus 10.09 ± 3.32 days, respectively. Mean difference 1.045 days; 95% confidence interval [CI] 0.098-1.992; P = 0.031 in the unadjusted model; mean difference 0.957 days; CI 0.007-1.907; P = 0.048 in adjusted model). The incidence of early discharge differed significantly between the PEA and control groups (41[46.1%] versus 24[27.0%] patients, respectively. Odds ratio [OR] 0.432; CI 0.231-0.809; P = 0.009 in unadjusted model; OR 0.466; CI 0.244-0.889, P = 0.02 in adjusted model). The time of first bowel movement, partial pressure O 2  and post-traumatic stress disorder score in the PEA group were better than those in the Control group. Participants walked much longer distances on day 3 in the PEA group than those in the Control group (76.12 ± 29.02 versus 56.80 ± 24.40 m, respectively, P < 0.001).
CONCLUSION


APMHR and VO 2max  are valuable for implementation of PEA according to an established security threshold. PEA after OPCAPG surgery is safe and reliable for elderly patients, not only reducing the hospital stay, but also improving their physiological and psychological symptoms.
TRIAL REGISTRATION


This study is a component of a protocol retrospectively registered: Application of ERAS in cardiovascular surgery.
TRIAL REGISTRATION NUMBER


ChiCTR1800018167 . Date of registration: 3rd September, 2018. URL of trial registry record: http://www.chictr.org.cn/index.aspx.",2020,Mean difference 1.045 days; 95% confidence interval [CI] 0.098-1.992; P = 0.031 in the unadjusted model; mean difference 0.957 days; CI 0.007-1.907; P = 0.048 in adjusted model).,"['178 patients were enrolled (n\u2009=\u200989 per group', 'elderly patients aged over 60\u2009years after off-pump coronary artery bypass graft (OPCABG) surgery', 'elderly patients undergoing off-pump coronary artery bypass graft surgery', 'elderly patients']","['ERAS', 'precision early ambulation (PEA) group or a routine ambulation (Control) group', 'OPCAPG surgery', 'http://www.chictr.org.cn/index.aspx', 'PEA']","['hospital stay', 'incidence of early discharge', 'Ambulation outcomes', 'time of first bowel movement, partial pressure O 2  and post-traumatic stress disorder score', 'postoperative length of stay in hospital (PLOS', '90-day mortality, incidence of early discharge, laboratory tests, length of ICU stay, the incidence of multiple organ complications and post-traumatic stress disorder (PTSD', 'maximal heart rate (APMHR) and maximal oxygen uptake (VO 2max']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1449706', 'cui_str': 'Off-pump coronary artery bypass'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C1521863', 'cui_str': 'estrogen receptor alpha, human'}, {'cui': 'C0013457', 'cui_str': 'Ambulation, Early'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0030604', 'cui_str': 'Partial pressure'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}]",178.0,0.229864,Mean difference 1.045 days; 95% confidence interval [CI] 0.098-1.992; P = 0.031 in the unadjusted model; mean difference 0.957 days; CI 0.007-1.907; P = 0.048 in adjusted model).,"[{'ForeName': 'Zhaomei', 'Initials': 'Z', 'LastName': 'Cui', 'Affiliation': 'Intensive Care Unit (ICU), Department of Cardiac Surgery, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan, 250021, Shandong, China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'Department of Gynecology, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan, 250021, Shandong, China.'}, {'ForeName': 'Chaonan', 'Initials': 'C', 'LastName': 'Gao', 'Affiliation': 'Department of Biostatistics, School of Public Health, Cheeloo College of Medicine, Shandong University, Jinan, 250012, Shandong, China.'}, {'ForeName': 'Yiou', 'Initials': 'Y', 'LastName': 'Fan', 'Affiliation': 'Department of Toxicological and Functional Test, Centers for Disease Control and Prevention of Shandong, Jinan, 250014, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Zhuang', 'Affiliation': 'Intensive Care Unit (ICU), Department of Cardiac Surgery, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan, 250021, Shandong, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Intensive Care Unit (ICU), Department of Cardiac Surgery, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan, 250021, Shandong, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Intensive Care Unit (ICU), Department of Cardiac Surgery, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan, 250021, Shandong, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Tan', 'Affiliation': 'Intensive Care Unit (ICU), Department of Cardiac Surgery, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan, 250021, Shandong, China. deepblue1229@163.com.'}]",BMC geriatrics,['10.1186/s12877-020-01823-1']
3390,33054794,"Evaluation of the efficacy of two doses of vitamin D supplementation on glycemic, lipidemic and oxidative stress biomarkers during pregnancy: a randomized clinical trial.","BACKGROUND


Vitamin D deficiency during pregnancy is common and is likely to be associated with metabolic complications in the mother. The aim of this study was to assess the efficacy of two doses of vitamin D supplementation during pregnancy on maternal and cord blood vitamin D status and metabolic and oxidative stress biomarkers.
METHODS


The eligible pregnant women (n = 84) invited to participate in the study and randomly allocated to one of the two supplementation groups (1000 IU/d vitamin D and 2000 IU/d). Biochemical assessments of mothers including serum concentrations of 25(OH)D, calcium, phosphate, iPTH, fasting serum sugar (FBS), insulin, triglyceride, total cholesterol, LDL-C, HDL-C, malondialdehyde (MDA) and total antioxidant capacity (TAC) were done at the beginning and 34 weeks of gestation. Cord blood serum concentrations of 25(OH)D, iPTH, MDA and TAC were assessed at delivery as well. To determine the effects of vitamin D supplementation on metabolic markers 1-factor repeated-measures analysis of variance (ANOVA) was used. Between groups comparisons was done by using Independent-samples Student's t-test or Mann-Whitney test. P < 0.05 was considered as significant.
RESULTS


Supplementation with 1000 IU/d and 2000 IU/d vitamin D resulted in significant changes in vitamin D status over pregnancy (24.01 ± 21.7, P < 0.001 in 1000 IU/d group and 46.7 ± 30.6 nmol/L, P < 0.001 in 2000 IU/d group). Daily intake of 2000 compared with 1000 IU/d tended to increase the serum concentration of HDL-C (10 ± 8.37, P < 0.001 in 1000 IU/d group and 9.52 ± 11.39 mg/dL, P < 0.001 in 2000 IU/d group). A significant decrement in serum concentration of iPTH observed in both groups (- 4.18 ± 7.5, P = 0.002 in 1000 IU/d group and - 8.36 ± 14.17, P = 0.002 in 2000 IU/d group).
CONCLUSIONS


Supplementation with 2000 IU/d vitamin D as compared with 1000 IU/d, is more effective in promoting vitamin D status and HDL-C serum concentration and in decreasing iPTH over pregnancy.
TRIAL REGISTRATION


This trial is registered at clinicaltrials.gov ( NCT03308487 ). Registered 12 October 2017 'retrospectively registered'.",2020,"A significant decrement in serum concentration of iPTH observed in both groups (- 4.18 ± 7.5, P = 0.002 in 1000 IU/d group and - 8.36 ± 14.17, P = 0.002 in 2000 IU/d group).
","['eligible pregnant women (n\u2009=\u200984) invited to participate in the study', 'pregnancy']","['vitamin D supplementation', 'vitamin D and 2000']","['glycemic, lipidemic and oxidative stress biomarkers', 'serum concentration of iPTH', 'Cord blood serum concentrations of 25(OH)D, iPTH, MDA and TAC', 'maternal and cord blood vitamin D status and metabolic and oxidative stress biomarkers', 'serum concentrations of 25(OH)D, calcium, phosphate, iPTH, fasting serum sugar (FBS), insulin, triglyceride, total cholesterol, LDL-C, HDL-C, malondialdehyde (MDA) and total antioxidant capacity (TAC', 'serum concentration of HDL-C', 'vitamin D status and HDL-C serum concentration', 'vitamin D status over pregnancy']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0470277', 'cui_str': '2000'}]","[{'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0047008', 'cui_str': ""3,4-O-isopropylidene-3,3',4,5'-tetrahydroxystilbene""}, {'cui': 'C0162371', 'cui_str': 'Cord blood'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]",,0.53284,"A significant decrement in serum concentration of iPTH observed in both groups (- 4.18 ± 7.5, P = 0.002 in 1000 IU/d group and - 8.36 ± 14.17, P = 0.002 in 2000 IU/d group).
","[{'ForeName': 'Soudabe', 'Initials': 'S', 'LastName': 'Motamed', 'Affiliation': 'Department of Cellular and Molecular Nutrition, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Bahareh', 'Initials': 'B', 'LastName': 'Nikooyeh', 'Affiliation': 'Laboratory of Nutrition Research, National Nutrition and Food Technology Research Institute and Faculty of Nutrition Sciences and Food Technology, Shahid Beheshti University of Medical Sciences, Hafezi St., Farahzadi Blvd., Shahrak Qods (Gharb), Tehran, 1981619573, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Kashanian', 'Affiliation': 'Department of Obstetrics & Gynecology, Akbarabadi Teaching Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Chamani', 'Affiliation': 'Department of Obstetrics & Gynecology, Akbarabadi Teaching Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Bruce W', 'Initials': 'BW', 'LastName': 'Hollis', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Medical University of South Carolina, Charleston, SC, 29425, USA.'}, {'ForeName': 'Tirang R', 'Initials': 'TR', 'LastName': 'Neyestani', 'Affiliation': 'Laboratory of Nutrition Research, National Nutrition and Food Technology Research Institute and Faculty of Nutrition Sciences and Food Technology, Shahid Beheshti University of Medical Sciences, Hafezi St., Farahzadi Blvd., Shahrak Qods (Gharb), Tehran, 1981619573, Iran. t.neyestani@sbmu.ac.ir.'}]",BMC pregnancy and childbirth,['10.1186/s12884-020-03311-1']
3391,33054811,Effectiveness of a home-based telerehabilitation system in patients after total hip arthroplasty: study protocol of a randomized controlled trial.,"BACKGROUND


The demand for total hip arthroplasty (THA) is quickly rising given the escalating global incidence of hip osteoarthritis, and it is widely accepted that the post-surgery rehabilitation is key to optimize outcomes. The overall objective of this study is to evaluate the effectiveness of a new telerehabilitation solution, ReHub, for the physical function and clinical outcome improvement following THA. The specific aims of this manuscript are to describe the study design, protocol, content of interventions, and primary and secondary outcomes and to discuss the clinical rehabilitation impact of the expected experimental results.
METHODS/DESIGN


This prospective, randomized, controlled, parallel-group trial will include 56 patients who had undergone primary THA. Patients are randomized to a control group (standard rehabilitation during the 2-week stay in the rehabilitation clinic followed by 3 weeks of unsupervised home-based rehabilitation) or an experimental group (standard rehabilitation during the 2-week stay in the rehabilitation clinic followed by 3 weeks of home-based ReHub-assisted telerehabilitation). The primary outcome is physical performance assessed through the Timed Up-and-Go (TUG) test. Secondary outcomes include independence level, pain intensity, hip disability, hip range of motion, muscle strength, and patient's perception of clinical improvement.
DISCUSSION


Proving the clinical and cost-effectiveness of a home-based telerehabilitation program for physical and muscle function following THA could support its systematic incorporation in post-surgical rehabilitation protocols, which should be tailored to the individual and collective needs.
TRIAL REGISTRATION


ClinicalTrial.gov NCT04176315 . Registered on 22 November 2019.",2020,"Proving the clinical and cost-effectiveness of a home-based telerehabilitation program for physical and muscle function following THA could support its systematic incorporation in post-surgical rehabilitation protocols, which should be tailored to the individual and collective needs.
","['patients after total hip arthroplasty', '56 patients who had undergone primary THA']","['home-based telerehabilitation program', 'total hip arthroplasty (THA', 'control group (standard rehabilitation during the 2-week stay in the rehabilitation clinic followed by 3\u2009weeks of unsupervised home-based rehabilitation) or an experimental group (standard rehabilitation during the 2-week stay in the rehabilitation clinic followed by 3\u2009weeks of home-based ReHub-assisted telerehabilitation', 'home-based telerehabilitation system']","[""independence level, pain intensity, hip disability, hip range of motion, muscle strength, and patient's perception of clinical improvement"", 'physical performance assessed through the Timed Up-and-Go (TUG) test']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4042802', 'cui_str': 'Remote Rehabilitation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C3839785', 'cui_str': 'Rehabilitation clinic'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0576002', 'cui_str': 'Hip joint - range of movement'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",56.0,0.0694637,"Proving the clinical and cost-effectiveness of a home-based telerehabilitation program for physical and muscle function following THA could support its systematic incorporation in post-surgical rehabilitation protocols, which should be tailored to the individual and collective needs.
","[{'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Busso', 'Affiliation': 'Division of Physical Medicine and Rehabilitation, Department of Surgical Sciences, University of Turin, C.so Dogliotti 14, 10126, Turin, Italy.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Castorina', 'Affiliation': 'Division of Physical Medicine and Rehabilitation, Department of Surgical Sciences, University of Turin, C.so Dogliotti 14, 10126, Turin, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Di Monaco', 'Affiliation': 'Division of Physical Medicine and Rehabilitation, Presidio Sanitario San Camillo, Fondazione Opera San Camillo, Turin, Italy.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Rodriguez', 'Affiliation': 'DyCare - Bio-Sensing Solutions S.L., Barcelona, Spain.'}, {'ForeName': 'Hadis', 'Initials': 'H', 'LastName': 'Mahdavi', 'Affiliation': 'DyCare - Bio-Sensing Solutions S.L., Barcelona, Spain.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Balocco', 'Affiliation': 'Department of Mathematics and Informatics, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Trucco', 'Affiliation': 'Division of Physical Medicine and Rehabilitation, Presidio Sanitario San Camillo, Fondazione Opera San Camillo, Turin, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Conti', 'Affiliation': 'MediSport, Human Performance Lab - Como and Varese, Varese, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Castagna', 'Affiliation': 'IRCCS Humanitas Institute, Milan, Italy.'}, {'ForeName': 'Marco Alessandro', 'Initials': 'MA', 'LastName': 'Minetto', 'Affiliation': 'Division of Physical Medicine and Rehabilitation, Department of Surgical Sciences, University of Turin, C.so Dogliotti 14, 10126, Turin, Italy. marco.minetto@unito.it.'}]",Trials,['10.1186/s13063-020-04791-4']
3392,33054825,Group intervention for siblings and parents of children with chronic disorders (SIBS-RCT): study protocol for a randomized controlled trial.,"BACKGROUND


Siblings and parents of children with neurodevelopmental disorders are at risk of mental health problems and poorer family communication. Some group interventions for siblings exist, but few have clearly described parent components and none are considered evidence-based.
METHODS


We are conducting a randomized controlled trial comparing a five-session manual-based group intervention for siblings (aged 8 to 16 years) and parents of children with neurodevelopmental disorders to a 12-week waitlist, called SIBS-RCT. The intervention comprises three separate sibling and parent group sessions and two joint sessions in which each sibling talks to their parent alone. The intervention aims at improving parent-child communication and covers themes such as siblings' understanding of the neurodevelopmental disorder, siblings' emotions, and perceived family challenges. Participants are recruited through municipal and specialist health centers across Norway. The primary outcome is sibling mental health. Quality of life and family communication are secondary outcomes. Participants are block-randomized to the intervention or 12-week waitlist in groups of six. Measures are collected electronically at pre- and post-intervention/waitlist, as well as 3, 6, and 12 months post-intervention. The main effect to be examined is the difference between the intervention and waitlist at 12 weeks post. All outcomes will also be examined using growth curve analyses. We plan to include 288 siblings and their parents by the end of 2022.
DISCUSSION


SIBS-RCT represents a major contribution to the research and practice field towards establishing an evidence-based intervention for siblings. In the event that intervention and waitlist are no different, the impact of SIBS-RCT is still substantial in that we will aim to identify participant subgroups that show positive response and effective components of the SIBS manual by examining group leader adherence as an outcome predictor. This will allow us to continue to re-engineer the SIBS manual iteratively to improve outcomes, and avoid the promotion of a less-than-optimal intervention.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04056884 . Registered in August 2019.",2020,The intervention comprises three separate sibling and parent group sessions and two joint sessions in which each sibling talks to their parent alone.,"['Participants are recruited through municipal and specialist health centers across Norway', '288 siblings and their parents by the end of 2022', 'siblings (aged 8 to 16\u2009years) and parents of children with neurodevelopmental disorders to a 12-week waitlist, called SIBS-RCT', 'Siblings and parents of children with neurodevelopmental disorders', 'siblings and parents of children with chronic disorders (SIBS-RCT']",['five-session manual-based group intervention'],"['sibling mental health', 'Quality of life and family communication']","[{'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0028423', 'cui_str': 'Norway'}, {'cui': 'C0037047', 'cui_str': 'Sibling'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1535926', 'cui_str': 'Neurodevelopmental disorder'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}]","[{'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0009452', 'cui_str': 'Communication'}]",,0.0802071,The intervention comprises three separate sibling and parent group sessions and two joint sessions in which each sibling talks to their parent alone.,"[{'ForeName': 'Krister W', 'Initials': 'KW', 'LastName': 'Fjermestad', 'Affiliation': 'Department of Psychology, University of Oslo, New Haven, Norway. kristefj@uio.no.'}, {'ForeName': 'Wendy K', 'Initials': 'WK', 'LastName': 'Silverman', 'Affiliation': 'Child Psychiatry, Child Study Center, New Haven, USA.'}, {'ForeName': 'Torun M', 'Initials': 'TM', 'LastName': 'Vatne', 'Affiliation': 'Department of Psychology, University of Oslo, New Haven, Norway.'}]",Trials,['10.1186/s13063-020-04781-6']
3393,33054828,Nocebo effects by providing informed consent in shared decision making? Not necessarily: a randomized pilot-trial using an open-label placebo approach.,"BACKGROUND


Thorough information of the patient is an integral part of the process of shared decision making. We aimed to investigate if detailed information about medication may induce nocebo (or placebo) effects.
METHODS


We conducted a randomized, single-blind, pilot-study including n = 51 psychiatric in-patients aged between 18 and 80 years with a depressive disorder and accompanying sleeping disorders. In the intervention group we provided thorough information about adverse effects, while the control group received only a simple consent procedure. In both groups, patients received an open-label placebo pill instead of their sleeping medication.
RESULTS


No statistically significant differences between the intervention group and the control group were found regarding the main outcome parameter (a visual analogue scale indicating impairment by the new pill).
CONCLUSION


In this study, we were not able detect an effect of informed consent vs. simple consent on the emergence of placebo or nocebo effects. This finding is contrary to most assumptions and publications about this topic.
TRIAL REGISTRATION


Trial registration number: DRKS00017653, registered August 30th 2018. Retrosprectively registered.",2020,"No statistically significant differences between the intervention group and the control group were found regarding the main outcome parameter (a visual analogue scale indicating impairment by the new pill).
",['n\xa0=\u200951 psychiatric in-patients aged between 18 and 80\u2009years with a depressive disorder and accompanying sleeping disorders'],"['nocebo (or placebo', 'placebo', 'open-label placebo approach', 'open-label placebo']",['visual analogue scale indicating impairment by the new pill'],"[{'cui': 'C0748064', 'cui_str': 'Psychiatric in-patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011581', 'cui_str': 'Depressive disorder'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C3658218', 'cui_str': 'Nocebo'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}]",,0.309487,"No statistically significant differences between the intervention group and the control group were found regarding the main outcome parameter (a visual analogue scale indicating impairment by the new pill).
","[{'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Holzhüter', 'Affiliation': 'Klinik und Poliklinik für Psychiatrie und Psychotherapie, Klinikum rechts der Isar, Technische Universität München, Möhlstraße 26, 81675, Munich, Germany. fabian.holzhueter@mri.tum.de.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Hamann', 'Affiliation': 'Klinik und Poliklinik für Psychiatrie und Psychotherapie, Klinikum rechts der Isar, Technische Universität München, Möhlstraße 26, 81675, Munich, Germany.'}]",BMC medical ethics,['10.1186/s12910-020-00541-y']
3394,33054836,The effect of life coaching on psychological distress among dental students: interventional study.,"BACKGROUND


Depression, stress, and anxiety are common psychological conditions among dental students in many countries around the world. A number of researchers have found life coaching to be effective at reducing psychological distress. The aim of this study was to assess the effect of a life coaching program on dental students' psychological status.
METHODS


A quasi-experiment study with two arms was conducted on 88 female dental students at Umm Al-Qura University (study group = 44; control group = 44). The psychological status was assessed by questionnaire before and after intervention. The questionnaire was composed of the Depression and Anxiety Stress Scale (DASS-21), Resilience Scale (RS-14), the Psychological Well-Being Scale-Short (PWB-S), and goal approach questions. The study group received a coaching program comprising one lecture for 1 h and five phone coaching sessions over 5 weeks, while the control group received no intervention.
RESULTS


The study group showed a significant reduction in depression, anxiety, stress, resilience, and self-acceptance according to the PWB-S scale. Also, goal approach was significantly improved. On the other hand, the control group showed a significant reduction on the RS-14 only. The differences in the tested scales between the study group and the control group from pre-intervention (T1) to post-intervention (T2) showed significant differences in depression, stress, self-acceptance, and goal approach measurements per t-test.
CONCLUSION


The study's findings showed that life coaching had the effect of reducing psychological distress, which encouraged the implementation of coaching practice in the daily life of dental students.",2020,"The study group showed a significant reduction in depression, anxiety, stress, resilience, and self-acceptance according to the PWB-S scale.","['88 female dental students at Umm Al-Qura University (study group\u2009=\u200944; control group\u2009=\u200944', 'dental students', ""dental students' psychological status""]","['life coaching program', 'coaching program comprising one lecture for 1\xa0h and five phone coaching sessions', 'control group received no intervention', 'life coaching']","['psychological distress', 'depression, anxiety, stress, resilience, and self-acceptance according to the PWB-S scale', 'depression, stress, self-acceptance, and goal approach measurements per t-test', 'Depression and Anxiety Stress Scale (DASS-21), Resilience Scale (RS-14), the Psychological Well-Being Scale-Short (PWB-S), and goal approach questions']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0038493', 'cui_str': 'Dental Student'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0449438', 'cui_str': 'Status'}]","[{'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0424578', 'cui_str': 'Well in self'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1832594', 'cui_str': 'Verloes Bourguignon syndrome'}]",88.0,0.0221632,"The study group showed a significant reduction in depression, anxiety, stress, resilience, and self-acceptance according to the PWB-S scale.","[{'ForeName': 'Khalid', 'Initials': 'K', 'LastName': 'Aboalshamat', 'Affiliation': 'Dental Public Health Division, Preventative Dentistry Department, College of Dentistry, Umm Al-Qura University, Makkah, Saudi Arabia. ktaboalshamat@uqu.edu.sa.'}, {'ForeName': 'Duha', 'Initials': 'D', 'LastName': 'Al-Zaidi', 'Affiliation': 'Dental Intern, College of Dentistry, Umm Al-Qura University, Makkah, Saudi Arabia.'}, {'ForeName': 'Duha', 'Initials': 'D', 'LastName': 'Jawa', 'Affiliation': 'Dental Intern, College of Dentistry, Umm Al-Qura University, Makkah, Saudi Arabia.'}, {'ForeName': 'Hanouf', 'Initials': 'H', 'LastName': 'Al-Harbi', 'Affiliation': 'Dental Intern, College of Dentistry, Umm Al-Qura University, Makkah, Saudi Arabia.'}, {'ForeName': 'Raghad', 'Initials': 'R', 'LastName': 'Alharbi', 'Affiliation': 'Dental Intern, College of Dentistry, Umm Al-Qura University, Makkah, Saudi Arabia.'}, {'ForeName': 'Shahad', 'Initials': 'S', 'LastName': 'Al-Otaibi', 'Affiliation': 'Dental Intern, College of Dentistry, Umm Al-Qura University, Makkah, Saudi Arabia.'}]",BMC psychology,['10.1186/s40359-020-00475-5']
3395,33054842,"Effect of probiotics on nasal and intestinal microbiota in people with high exposure to particulate matter ≤ 2.5 μm (PM2.5): a randomized, double-blind, placebo-controlled clinical study.","BACKGROUND


Extended exposure to high concentrations of PM2.5 changes the human microbiota profile, which in turn may increase morbidity and mortality due to respiratory system damage. A balanced microecosystem is crucial to human health, and certain health-related problems may be addressed by effective microecosystem regulation. Recent studies have confirmed that probiotics may reduce the incidence of respiratory diseases. However, few studies have investigated probiotic treatment outcomes in subjects exposed to high concentrations of PM2.5.
METHODS


This study is designed as a prospective, randomized, participants- and assessor-blinded, placebo-controlled trial. One hundred and twenty eligible volunteers recruited from October 2019 to July 2020 in downtown Chengdu, China, will be treated with either probiotics or placebo over 4 consecutive weeks. The primary outcome will be 16SrRNA sequencing assay data from nasal and intestinal secretions. Secondary outcomes will be pulmonary function, score on a gastrointestinal symptom rating scale, COOP/WONCA charts, and the Short-Form Health Survey 36 for quality of life. Results will be analyzed to assess differences in clinical efficacy between groups. Six-month follow-up examinations will evaluate the long-term value of probiotics on cardiovascular and respiratory disease end-point events.
DISCUSSION


We will explore the characteristics of nasal and intestinal microbiota in a population with high exposure to PM2.5. Probiotics and placebo interventions will be tested for efficacy in microbial balance regulation, effects on lung and physical functions, and quality of life improvement. This study is expected to provide reliable evidence to support the widespread promotion of probiotics in clinical practice for the protection of individuals with high exposure to PM2.5.
TRIAL REGISTRATION


Chinese Clinical Trial Registry ChiCTR1900025469 . Registered on 27 August 2019.",2020,"Secondary outcomes will be pulmonary function, score on a gastrointestinal symptom rating scale, COOP/WONCA charts, and the Short-Form Health Survey 36 for quality of life.","['One hundred and twenty eligible volunteers recruited from October 2019 to July 2020 in downtown Chengdu, China, will be treated with either', 'people with high exposure to particulate matter ≤\u20092.5\u2009μm (PM2.5', 'individuals with high exposure to PM2.5', 'population with high exposure to PM2.5']","['Probiotics and placebo interventions', 'placebo', 'probiotics', 'probiotics or placebo']","['clinical efficacy', 'pulmonary function, score on a gastrointestinal symptom rating scale, COOP/WONCA charts, and the Short-Form Health Survey 36 for quality of life', 'lung and physical functions, and quality of life improvement', '16SrRNA sequencing assay data from nasal and intestinal secretions', 'nasal and intestinal microbiota']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C1720884', 'cui_str': 'Particulate Matter'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0684240', 'cui_str': 'Chart'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0021849', 'cui_str': 'Intestinal Secretions'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}]",120.0,0.331946,"Secondary outcomes will be pulmonary function, score on a gastrointestinal symptom rating scale, COOP/WONCA charts, and the Short-Form Health Survey 36 for quality of life.","[{'ForeName': 'Yongcan', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': ""Hospital of Chengdu University of Traditional Chinese Medicine, No. 39 Shi-er-qiao Road, Chengdu, 610072, Sichuan Province, People's Republic of China.""}, {'ForeName': 'Caixia', 'Initials': 'C', 'LastName': 'Pei', 'Affiliation': ""Hospital of Chengdu University of Traditional Chinese Medicine, No. 39 Shi-er-qiao Road, Chengdu, 610072, Sichuan Province, People's Republic of China.""}, {'ForeName': 'Xiaomin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""Hospital of Chengdu University of Traditional Chinese Medicine, No. 39 Shi-er-qiao Road, Chengdu, 610072, Sichuan Province, People's Republic of China.""}, {'ForeName': 'Mingjie', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': ""Hospital of Chengdu University of Traditional Chinese Medicine, No. 39 Shi-er-qiao Road, Chengdu, 610072, Sichuan Province, People's Republic of China.""}, {'ForeName': 'Demei', 'Initials': 'D', 'LastName': 'Huang', 'Affiliation': ""Hospital of Chengdu University of Traditional Chinese Medicine, No. 39 Shi-er-qiao Road, Chengdu, 610072, Sichuan Province, People's Republic of China.""}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': ""Hospital of Chengdu University of Traditional Chinese Medicine, No. 39 Shi-er-qiao Road, Chengdu, 610072, Sichuan Province, People's Republic of China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Xiao', 'Affiliation': ""Hospital of Chengdu University of Traditional Chinese Medicine, No. 39 Shi-er-qiao Road, Chengdu, 610072, Sichuan Province, People's Republic of China.""}, {'ForeName': 'Zhenxing', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': ""Hospital of Chengdu University of Traditional Chinese Medicine, No. 39 Shi-er-qiao Road, Chengdu, 610072, Sichuan Province, People's Republic of China. wangzhenxing@vip.tom.com.""}]",Trials,['10.1186/s13063-020-04759-4']
3396,33055078,"Efficacy of tocilizumab in patients with hand osteoarthritis: double blind, randomised, placebo-controlled, multicentre trial.","OBJECTIVE


To evaluate the efficacy of tocilizumab, an antibody against IL-6 receptor, in patients with hand osteoarthritis.
METHODS


This was a multicentre, 12-week, randomised, double-blind, placebo-controlled study from November 2015 to October 2018. Patients with symptomatic hand osteoarthritis (pain ≥40 on a 0-100 mm visual analogue scale (VAS) despite analgesics and non-steroidal anti-inflammatory drugs; at least three painful joints, Kellgren-Lawrence grade ≥2) were randomised to receive two infusions 4 weeks apart (weeks 0 and 4) of tocilizumab (8 mg/kg intravenous) or placebo. The primary endpoint was changed in VAS pain at week 6. Secondary outcomes included the number of painful and swollen joints, duration of morning stiffness, patients' and physicians' global assessment and function scores.
RESULTS


Of 104 patients screened, 91 (45 to tocilizumab and 46 to placebo; 82% women; mean age 64.4 (SD 8.7) years) were randomly assigned and 79 completed the 12-week study visit. The mean change between baseline and week 6 on the VAS for pain (primary outcome) was -7.9 (SD 19.4) and -9.9 (SD 20.1) in the tocilizumab and placebo groups (p=0.7). The groups did not differ for any secondary outcomes at weeks 4, 6, 8 or 12. Overall, adverse events were slightly more frequent in the tocilizumab than placebo group.
CONCLUSION


Tocilizumab was no more effective than placebo for pain relief in patients with hand osteoarthritis.",2020,"The groups did not differ for any secondary outcomes at weeks 4, 6, 8 or 12.","['patients with hand osteoarthritis', '104 patients screened, 91 (45 to tocilizumab and 46 to placebo; 82% women; mean age 64.4 (SD 8.7) years', 'November 2015 to October 2018', 'Patients with symptomatic hand osteoarthritis (pain ≥40 on a 0-100\u2009mm visual analogue scale (VAS) despite analgesics and non-steroidal anti-inflammatory drugs; at least three painful joints, Kellgren-Lawrence grade ≥2']","['Tocilizumab', 'placebo', 'tocilizumab']","['adverse events', ""number of painful and swollen joints, duration of morning stiffness, patients' and physicians' global assessment and function scores"", 'pain relief', 'VAS pain', 'VAS for pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0263746', 'cui_str': 'Degenerative joint disease of hand'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1609165', 'cui_str': 'tocilizumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517880', 'cui_str': '8.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C0003862', 'cui_str': 'Joint pain'}, {'cui': 'C0441800', 'cui_str': 'Grade'}]","[{'cui': 'C1609165', 'cui_str': 'tocilizumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0152031', 'cui_str': 'Joint swelling'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0457086', 'cui_str': 'Morning stiffness - joint'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",,0.750294,"The groups did not differ for any secondary outcomes at weeks 4, 6, 8 or 12.","[{'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Richette', 'Affiliation': 'APHP, Hôpital Lariboisière, Service de Rhumatologie, Paris, France pascal.richette@aphp.fr.'}, {'ForeName': 'Augustin', 'Initials': 'A', 'LastName': 'Latourte', 'Affiliation': 'APHP, Hôpital Lariboisière, Service de Rhumatologie, Paris, France.'}, {'ForeName': 'Jérémie', 'Initials': 'J', 'LastName': 'Sellam', 'Affiliation': 'Rheumatology, INSERM UMRS_938, Sorbonnes Université UPMC Univ Paris 06, St-Antoine Hospital, DHU i2B, Paris, France.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Wendling', 'Affiliation': 'Rheumatology, CHU J Minjoz, Besancon, France.'}, {'ForeName': 'Muriel', 'Initials': 'M', 'LastName': 'Piperno', 'Affiliation': 'Rheumatology, University Claude Bernard, Lyon, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Goupille', 'Affiliation': 'Rheumatology, Trousseau University Hospital, Tours, France.'}, {'ForeName': 'Yves-Marie', 'Initials': 'YM', 'LastName': 'Pers', 'Affiliation': 'Clinical Immunology and Osteoarticular Diseases Therapeutic Unit, CHRU Lapeyronie, Montpellier, France.'}, {'ForeName': 'Florent', 'Initials': 'F', 'LastName': 'Eymard', 'Affiliation': 'Department of Rheumatology, APHP Henri Mondor Hospital, Créteil, France.'}, {'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Ottaviani', 'Affiliation': 'Rheumatology, Hospital Bichat-Claude-Bernard, Paris, Île-de-France, France.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Ornetti', 'Affiliation': 'Rheumatology, Burgundy Franche-Comté University, Dijon, France.'}, {'ForeName': 'René-Marc', 'Initials': 'RM', 'LastName': 'Flipo', 'Affiliation': 'Service de Rhumatologie, CHU Roger Salengro, Université de Lille, Lille, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Fautrel', 'Affiliation': 'Rheumatology, Assistance Publique - Hopitaux de Paris, Paris, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Peyr', 'Affiliation': 'Service de Rhumatologie, Hopital Lariboisiere Centre Viggo Petersen, Paris, Île-de-France, France.'}, {'ForeName': 'Jean Pierre', 'Initials': 'JP', 'LastName': 'Bertola', 'Affiliation': 'Medical Affair, Chugai Pharma France SAS, Paris La Defense, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Vicaut', 'Affiliation': 'Unité de recherche clinique, Groupe hospitalier Lariboisiere Fernand-Widal, Paris, Île-de-France, France.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Chevalier', 'Affiliation': 'Department of Rheumatology, APHP Henri Mondor Hospital, Créteil, France.'}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2020-218547']
3397,33049119,Randomized pilot trial of ipratropium versus placebo in children with critical asthma.,"OBJECTIVE


To test the effects of inhaled ipratropium on clinical outcomes of critical asthma in the first randomized trial of this adjunctive therapy in critically ill children.
DESIGN


Pilot, placebo-controlled, double-blinded, and randomized-controlled trial PATIENTS: Thirty children (15 per group) with critical asthma receiving high-intensity albuterol per a standardized pathway utilizing objective assessments to wean patients to less frequent albuterol administration.
INTERVENTIONS


Subjects were randomized to receive either nebulized ipratropium bromide (500 µg in 0.9% saline per dose) or an equivalent volume of nebulized 0.9% saline every 6 h until the patient was successfully weaned to albuterol doses every 2 h (""q2 albuterol"").
MEASUREMENTS AND MAIN RESULTS


Demographics, initial clinical severity score, and asthma histories were similar between groups. There was no significant difference in the median duration of high-intensity albuterol between the treatment group (17.5 [10.3-22.1] h) and placebo group (14.6 [12.7-24.5] days; p = .56). Similarly, there was no significant difference in pediatric intensive care unit length of stay (22.6 [21.1-33.6] vs. 21.4 [16.1-35.8] h; p = .74) or hospital length of stay (48.0 [41.8-59.8] vs. 47.3 [37.2-63.1] h; p = .67). In multivariate linear regression adjusting for identified confounders, treatment with ipratropium was not significantly associated with any of the three outcomes. Side effects were rare and occurred with equally between both groups CONCLUSIONS: Adjunctive therapy with ipratropium was not associated with decreased duration of high-intensity albuterol or shortened length of stay when compared to placebo. A larger, multicenter trial is warranted to confirm that ipratropium does not improve clinical outcomes.",2020,Adjunctive therapy with ipratropium was not associated with decreased duration of high intensity albuterol or shortened length of stay when compared to placebo.,"['critically ill children', 'Thirty children (15/group) with critical asthma receiving high-intensity albuterol per a standardized pathway utilizing objective assessments to wean patients to less frequent albuterol administration', 'Children with Critical Asthma']","['nebulized ipratropium bromide (500µg in 0.9% saline per dose) or an equivalent volume of nebulized 0.9% saline', 'placebo', 'ipratropium', 'Ipratropium', 'inhaled ipratropium', 'Placebo']","['median duration of high intensity albuterol', 'PICU length of stay', 'duration of high intensity albuterol or shortened length of stay', 'hospital length of stay', 'Demographics, initial clinical severity score, and asthma histories']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0001927', 'cui_str': 'Albuterol'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0043084', 'cui_str': 'Weaning'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0700580', 'cui_str': 'ipratropium bromide'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0027235', 'cui_str': 'Ipratropium'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0001927', 'cui_str': 'Albuterol'}, {'cui': 'C1046445', 'cui_str': 'Picus'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0441636', 'cui_str': 'Surgical shortening - action'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0019664', 'cui_str': 'History'}]",,0.615042,Adjunctive therapy with ipratropium was not associated with decreased duration of high intensity albuterol or shortened length of stay when compared to placebo.,"[{'ForeName': 'Kaitlyn', 'Initials': 'K', 'LastName': 'Murphy', 'Affiliation': ""Division of Pediatric Critical Care Medicine, Rainbow Babies and Children's Hospital, Cleveland, Ohio, USA.""}, {'ForeName': 'Nabihah', 'Initials': 'N', 'LastName': 'Mahmood', 'Affiliation': ""Division of Pediatric Critical Care Medicine, Rainbow Babies and Children's Hospital, Cleveland, Ohio, USA.""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Craven', 'Affiliation': ""Division of Pediatric Pulmonology, Rainbow Babies and Children's Hospital, Cleveland, Ohio, USA.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Gallagher', 'Affiliation': ""Department of Respiratory Care, Rainbow Babies and Children's Hospital, Cleveland, Ohio, USA.""}, {'ForeName': 'Kristie', 'Initials': 'K', 'LastName': 'Ross', 'Affiliation': ""Division of Pediatric Pulmonology, Rainbow Babies and Children's Hospital, Cleveland, Ohio, USA.""}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Speicher', 'Affiliation': ""Division of Pediatric Critical Care Medicine, Rainbow Babies and Children's Hospital, Cleveland, Ohio, USA.""}, {'ForeName': 'Alexandre T', 'Initials': 'AT', 'LastName': 'Rotta', 'Affiliation': ""Division of Pediatric Critical Care Medicine, Rainbow Babies and Children's Hospital, Cleveland, Ohio, USA.""}, {'ForeName': 'Steven L', 'Initials': 'SL', 'LastName': 'Shein', 'Affiliation': ""Division of Pediatric Critical Care Medicine, Rainbow Babies and Children's Hospital, Cleveland, Ohio, USA.""}]",Pediatric pulmonology,['10.1002/ppul.25115']
3398,33049411,The effect of multiple-dose oral versus intravenous tranexamic acid in reducing postoperative blood loss and transfusion rate after adolescent scoliosis surgery: a randomized controlled trial.,"BACKGROUND CONTEXT


Tranexamic acid (TXA) is widely used in surgery for adolescent idiopathic scoliosis (AIS) and has been proved to be efficacious in reducing intraoperative blood loss (IBL) and the transfusion rate. However, the routine TXA regimen was intraoperative administration alone, in which the concentration of TXA could not cover the whole process of hyperfibrinolysis. And, its ability to control the massive postoperative blood loss (PBL) may be insufficient. Thus, we promoted a multiple-dose regimen of TXA for patients with AIS who underwent surgical correction.
PURPOSE


The primary aims were (1) to determine whether the multiple-dose regimen of TXA could reduce PBL and the postoperative transfusion rate, and (2) to compare the efficacy of oral administration with intravenous administration. The secondary aims were (3) to evaluate whether this regimen could alleviate inflammatory response, and (4) to assess the occurrence of drug-related side effects.
STUDY DESIGN


Prospective, double-blinded, randomized controlled trial.
PATIENT SAMPLE


A total of 108 patients with AIS who underwent posterior scoliosis correction and spinal fusion (PSS) were enrolled in this study.
OUTCOME MEASURES


The primary parameters were PBL and postoperative transfusion rate. Other parameters such as total blood loss (TBL), maximum hemoglobin (Hb) decrease, volume of drainage, inflammation markers (interleukin-6 [IL-6] and C-reactive protein [CRP]), and occurrence of complications were also collected and compared. Multiple regression analysis was used to examine the variables that affected PBL.
METHODS


Patients were randomized into three groups. All patients received intravenous TXA 50 mg/kg loading dose and 10 mg/kg/h maintenance dose during surgery. Group A received 1 g oral TXA at 4 hours, 10 hours, and 16 hours postoperatively; group B received 0.5 g intravenous TXA at 6 hours, 12 hours, and 18 hours postoperatively; group C received placebo.
RESULTS


The mean PBL and postoperative transfusion rate in group A (957.8±378.9 mL, 13.89%) and B (980.3±491.8 mL, 11.11%) were significantly lower than those in group C [1,495.9±449.6 mL, mean differences=538.1 mL, 95% confidence interval (CI), 290.1-786.1 mL, p<0.001; 515.6 mL, 95% CI, 267.6-763.6 mL, p<.001]; (36.11%, p=.029, p=.013). Meanwhile, the mean TBL, maximum Hb decrease, and volume of drainage were also significantly lower in group A and B than in group C. IL-6 and CRP in group A and B were significantly lower than in group C from postoperative days 1 to 3. All these differences were not significant between groups A and B. No drug-related complications were observed in any patient. Multiple regression showed that the application of postoperative TXA and number of screws were significant parameters affecting PBL.
CONCLUSIONS


A multiple-dose regimen of TXA, either by oral or intravenous application, could be a safe and effective means of controlling PBL and decreasing the postoperative transfusion rate in patients with AIS who underwent scoliosis surgery. In addition, it could inhibit postoperative inflammatory response.",2020,All these differences were not significant between groups A and B. No drug-related complications were observed in any patient.,"['adolescent idiopathic scoliosis (AIS', 'Patients', 'adolescent scoliosis surgery', 'patients with AIS who underwent surgical correction', '108 patients with AIS who underwent posterior scoliosis correction and spinal fusion (PSS', 'patients with AIS who underwent scoliosis surgery', 'SAMPLE']","['Tranexamic acid (TXA', 'intravenous TXA', 'tranexamic acid', 'placebo', '1 g oral TXA', 'TXA']","['PBL and the postoperative transfusion rate', 'total blood loss (TBL), maximum hemoglobin (Hb) decrease, volume of drainage, inflammation markers [interleukin-6 (IL-6) and C-reactive protein (CRP)], and occurrence of complications', 'postoperative blood loss and transfusion rate', 'postoperative transfusion rate', 'mean TBL, maximum Hb decrease, and volume of drainage', 'mean PBL and postoperative transfusion rate', 'PBL and postoperative transfusion rate', 'occurrence of drug-related side effects']","[{'cui': 'C0410702', 'cui_str': 'Adolescent idiopathic scoliosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0854477', 'cui_str': 'Scoliosis surgery'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0408736', 'cui_str': 'Correction of scoliosis'}, {'cui': 'C0037935', 'cui_str': 'Spinal arthrodesis'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0032788', 'cui_str': 'Postoperative hemorrhage'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0232100', 'cui_str': 'Exsanguination'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0162119', 'cui_str': 'Hemoglobin low'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",108.0,0.105372,All these differences were not significant between groups A and B. No drug-related complications were observed in any patient.,"[{'ForeName': 'Zhuang', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': ""Department of Orthopedic Surgery and Orthopedic Research Institute, West China Hospital, Sichuan University, No.37, Guoxue Rd, Wuhou District, Chengdu 610041, Sichuan, People's Republic of China.""}, {'ForeName': 'Lin-Nan', 'Initials': 'LN', 'LastName': 'Wang', 'Affiliation': ""Department of Orthopedic Surgery and Orthopedic Research Institute, West China Hospital, Sichuan University, No.37, Guoxue Rd, Wuhou District, Chengdu 610041, Sichuan, People's Republic of China.""}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': ""Department of Orthopedic Surgery and Orthopedic Research Institute, West China Hospital, Sichuan University, No.37, Guoxue Rd, Wuhou District, Chengdu 610041, Sichuan, People's Republic of China.""}, {'ForeName': 'Li-Min', 'Initials': 'LM', 'LastName': 'Liu', 'Affiliation': ""Department of Orthopedic Surgery and Orthopedic Research Institute, West China Hospital, Sichuan University, No.37, Guoxue Rd, Wuhou District, Chengdu 610041, Sichuan, People's Republic of China.""}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Xiu', 'Affiliation': ""Department of Orthopedic Surgery and Orthopedic Research Institute, West China Hospital, Sichuan University, No.37, Guoxue Rd, Wuhou District, Chengdu 610041, Sichuan, People's Republic of China.""}, {'ForeName': 'Zhong-Jie', 'Initials': 'ZJ', 'LastName': 'Zhou', 'Affiliation': ""Department of Orthopedic Surgery and Orthopedic Research Institute, West China Hospital, Sichuan University, No.37, Guoxue Rd, Wuhou District, Chengdu 610041, Sichuan, People's Republic of China.""}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': ""Department of Orthopedic Surgery and Orthopedic Research Institute, West China Hospital, Sichuan University, No.37, Guoxue Rd, Wuhou District, Chengdu 610041, Sichuan, People's Republic of China.""}, {'ForeName': 'Yue-Ming', 'Initials': 'YM', 'LastName': 'Song', 'Affiliation': ""Department of Orthopedic Surgery and Orthopedic Research Institute, West China Hospital, Sichuan University, No.37, Guoxue Rd, Wuhou District, Chengdu 610041, Sichuan, People's Republic of China. Electronic address: prof_songyueming@163.com.""}]",The spine journal : official journal of the North American Spine Society,['10.1016/j.spinee.2020.10.011']
3399,33049424,The impact of prior and ongoing threat on the false alarm threshold for facial discrimination.,"BACKGROUND AND OBJECTIVES


Perceptual adaptations that facilitate rapid responses to threats can also lead to false alarms, or the failure to discriminate safe stimuli from signals of threat. We examined the impact of varying degrees of threat on false alarms in the perceptual discrimination of faces along the dimension of emotion (Experiment 1) or identity (Experiment 2).
METHODS


Participants first trained to discriminate between a target and nontarget face. Next, we tested their ability to identify the target in randomized presentations of the target, the nontarget, and nine novel stimuli morphed in 10% increments of similarity from the target to the nontarget. The task was completed under one of three randomized conditions: 1) Ongoing-Threat paired the target with an aversive outcome in both phases; 2) Prior-Threat paired the target with an aversive outcome in the training phase only; and 3) No-Threat paired the target with a neutral outcome in the training phase only.
RESULTS


In Experiment 1 (N = 90), Ongoing-Threat lowered the false alarm threshold for facial discrimination based on anger intensity compared to Prior-Threat and No-Threat. In Experiment 2 (N = 90), Ongoing-Threat and Prior-Threat each lowered the false alarm threshold for identity-based discrimination compared to No-Threat.
LIMITATIONS


The experiment did not measure generalization of threat responses.
CONCLUSION


Associating a facial expression or identity with threat leads to faster but less accurate discrimination of faces with similar features, particularly under conditions of ongoing threat. These experiments provide an avenue for examining the parameters that impact false alarms, which play a key role in anxiety disorders.",2020,"In Experiment 1 (N = 90), Ongoing-Threat lowered the false alarm threshold for facial discrimination based on anger intensity compared to Prior-Threat and No-Threat.",['Participants first trained to discriminate between a target and nontarget face'],[],[],"[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0205235', 'cui_str': 'Discriminate'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}]",[],[],,0.0222255,"In Experiment 1 (N = 90), Ongoing-Threat lowered the false alarm threshold for facial discrimination based on anger intensity compared to Prior-Threat and No-Threat.","[{'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Papini', 'Affiliation': 'The University of Texas at Austin, USA. Electronic address: spapini@utexas.edu.'}, {'ForeName': 'Joseph E', 'Initials': 'JE', 'LastName': 'Dunsmoor', 'Affiliation': 'The University of Texas at Austin, USA.'}, {'ForeName': 'Jasper A J', 'Initials': 'JAJ', 'LastName': 'Smits', 'Affiliation': 'The University of Texas at Austin, USA.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101619']
3400,33049433,Selecting the optimal treatment for a depressed individual: Clinical judgment or statistical prediction?,"BACKGROUND


Optimizing treatment selection is a way to enhance treatment success in major depressive disorder (MDD). In clinical practice, treatment selection heavily depends on clinical judgment. However, research has consistently shown that statistical prediction is as accurate - or more accurate - than predictions based on clinical judgment. In the context of new technological developments, the current aim was to compare the accuracy of clinical judgment versus statistical predictions in selecting cognitive therapy (CT) or interpersonal psychotherapy (IPT) for MDD.
METHODS


Data came from a randomized trial comparing CT (n=76) with IPT (n=75) for MDD. Prior to randomization, therapists' recommendations were formulated during multidisciplinary staff meetings. Statistical predictions were based on Personalized Advantage Index models. Primary outcomes were post-treatment and 17-month follow-up depression severity. Secondary outcome was treatment dropout.
RESULTS


Individuals receiving treatment according to their statistical prediction were less depressed at post-treatment and follow-up compared to those receiving their predicted non-indicated treatment. This difference was not found for recommended versus non-recommended treatments based on clinical judgment. Moreover, for individuals with an IPT recommendation by therapists, higher post-treatment and follow-up depression severity was found for those that actually received IPT compared to those that received CT. Recommendations based on statistical prediction and clinical judgment were not associated with differences in treatment dropout.
LIMITATIONS


Information on the clinical reasoning behind therapist recommendations was not collected, and statistical predictions were not externally validated.
CONCLUSIONS


Statistical prediction outperforms clinical judgment in treatment selection for MDD and has the potential to personalize treatment strategies.",2020,"RESULTS


Individuals receiving treatment according to their statistical prediction were less depressed at post-treatment and follow-up compared to those receiving their predicted non-indicated treatment.","['n=76) with IPT (n=75) for MDD', 'major depressive disorder (MDD']","['CT', 'IPT', 'cognitive therapy (CT) or interpersonal psychotherapy (IPT']","['treatment dropout', 'post-treatment and 17-month follow-up depression severity']","[{'cui': 'C0380193', 'cui_str': 'iodine-123-IPT'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]","[{'cui': 'C0380193', 'cui_str': 'iodine-123-IPT'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0871787', 'cui_str': 'Interpersonal psychotherapy'}]","[{'cui': 'C0030686', 'cui_str': 'Patient Dropouts'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",76.0,0.0177431,"RESULTS


Individuals receiving treatment according to their statistical prediction were less depressed at post-treatment and follow-up compared to those receiving their predicted non-indicated treatment.","[{'ForeName': 'Suzanne C', 'Initials': 'SC', 'LastName': 'van Bronswijk', 'Affiliation': 'Department of Clinical Psychological Science, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, 6200, MD Maastricht, the Netherlands. Electronic address: suzanne.vanbronswijk@maastrichtuniversity.nl.'}, {'ForeName': 'Lotte H J M', 'Initials': 'LHJM', 'LastName': 'Lemmens', 'Affiliation': 'Department of Clinical Psychological Science, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, 6200, MD Maastricht, the Netherlands.'}, {'ForeName': 'Marcus J H', 'Initials': 'MJH', 'LastName': 'Huibers', 'Affiliation': 'Department of Clinical Psychology, VU University Amsterdam, Van der Boechorststraat 1, 1081 BT Amsterdam, the Netherlands; Department of Psychology, University of Pennsylvania, 3720 Walnut Street, Philadelphia, PA 19104-6241, USA.'}, {'ForeName': 'Frenk P M L', 'Initials': 'FPML', 'LastName': 'Peeters', 'Affiliation': 'Department of Clinical Psychological Science, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, 6200, MD Maastricht, the Netherlands.'}]",Journal of affective disorders,['10.1016/j.jad.2020.09.135']
3401,33049434,Acute Effects of Cannabis on Symptoms of Obsessive-Compulsive Disorder.,"BACKGROUND


Little is known about the the acute effects of cannabis on symptoms of OCD in humans. Therefore, this study sought to: 1) examine whether symptoms of OCD are significantly reduced after inhaling cannabis, 2) examine predictors (gender, dose, cannabis constituents, time) of these symptom changes and 3) explore potential long-term consequences of repeatedly using cannabis to self-medicate for OCD symptoms, including changes in dose and baseline symptom severity over time.
METHOD


Data were analyzed from the app Strainprint® which provides medical cannabis patients a means of tracking changes in symptoms as a function of different doses and strains of cannabis across time. Specifically, data were analyzed from 87 individuals self-identifying with OCD who tracked the severity of their intrusions, compulsions, and/or anxiety immediately before and after 1,810 cannabis use sessions spanning a period of 31 months.
RESULTS


Patients reported a 60% reduction in compulsions, a 49% reduction in intrusions, and a 52% reduction in anxiety from before to after inhaling cannabis. Higher concentrations of CBD and higher doses predicted larger reductions in compulsions. The number of cannabis use sessions across time predicted changes in intrusions, such that later cannabis use sessions were associated with smaller reductions in intrusions. Baseline symptom severity and dose remained fairly constant over time.
LIMITATIONS


The sample was self-selected, self-identified as having OCD, and there was no placebo control group.
CONCLUSIONS


Inhaled cannabis appears to have short-term beneficial effects on symptoms of OCD. However, tolerance to the effects on intrusions may develop over time.",2020,"RESULTS


Patients reported a 60% reduction in compulsions, a 49% reduction in intrusions, and a 52% reduction in anxiety from before to after inhaling cannabis.","['87 individuals self-identifying with OCD who tracked the severity of their intrusions, compulsions, and/or anxiety immediately before and after 1,810 cannabis use sessions spanning a period of 31 months', 'Data were analyzed from the app Strainprint® which provides medical cannabis patients a means of tracking changes in symptoms as a function of different doses and strains of cannabis across time']",['Cannabis'],"['Symptoms of Obsessive-Compulsive Disorder', 'anxiety', 'compulsions']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0009595', 'cui_str': 'Obsessive compulsive personality disorder'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600104', 'cui_str': 'Compulsive behavior'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C3160814', 'cui_str': 'Cannabis use'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0813973', 'cui_str': 'Medical Cannabis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0040223', 'cui_str': 'Time'}]","[{'cui': 'C0024808', 'cui_str': 'Marihuana'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0600104', 'cui_str': 'Compulsive behavior'}]",,0.034413,"RESULTS


Patients reported a 60% reduction in compulsions, a 49% reduction in intrusions, and a 52% reduction in anxiety from before to after inhaling cannabis.","[{'ForeName': 'Dakota', 'Initials': 'D', 'LastName': 'Mauzay', 'Affiliation': 'Washington State University, Department of Psychology, Pullman, WA, US.'}, {'ForeName': 'Emily M', 'Initials': 'EM', 'LastName': 'LaFrance', 'Affiliation': 'Washington State University, Department of Psychology, Pullman, WA, US.'}, {'ForeName': 'Carrie', 'Initials': 'C', 'LastName': 'Cuttler', 'Affiliation': 'Washington State University, Department of Psychology, Pullman, WA, US. Electronic address: carrie.cuttler@wsu.edu.'}]",Journal of affective disorders,['10.1016/j.jad.2020.09.124']
3402,33049455,The effectiveness of brief animated films as a scalable micro-intervention to improve children's body image: A randomised controlled trial.,"Creating media to counteract the plethora of media and advertising that perpetuates negative body image is a scalable public health strategy that can be achieved through innovative micro-interventions. This study examined the immediate and short-term (one-week follow-up) impact of viewing brief, evidence-informed animated films on young people's body image, media literacy, and self-efficacy in addressing appearance teasing. The animations were co-created through a partnership among academics, a personal care brand's social mission, and a children's television channel. Participants aged 7-14 (N = 1329, 49 % girls) were randomised into one of three viewing conditions: Appearance Teasing & Bullying, Media & Celebrities, or a non-appearance-related animation. Contrary to predictions, all three animations were comparably effective at eliciting intervention effects. For girls and boys aged 7-10, all three animations immediately improved state body satisfaction (+boys aged 11-14; Cohen's ds = .60-.71) and led to sustained improvements in trait media literacy (+girls aged 11-14; ds = .38-.61), sensitivity to appearance teasing (+boys aged 11-14; ds = .35-.48), and willingness to ignore appearance teasing (7-10 years only; ds = .34-.74) at one-week follow-up. Findings indicate that children's media is an effective medium for developing micro-interventions.",2020,"For girls and boys aged 7-10, all three animations immediately improved state body satisfaction (+boys aged 11-14; Cohen's ds = .60-.71) and led to sustained improvements in trait media literacy (+girls aged 11-14; ds = .38-.61), sensitivity to appearance teasing (+boys aged 11-14; ds = .35-.48), and willingness to ignore appearance teasing (7-10 years only; ds = .34-.74) at one-week follow-up.","['Participants aged 7-14 (N = 1329, 49 % girls', ""children's body image""]","['viewing brief, evidence-informed animated films']","['state body satisfaction', 'trait media literacy', 'sensitivity to appearance teasing']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0005891', 'cui_str': 'Body image'}]","[{'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0700287', 'cui_str': 'Informing'}, {'cui': 'C1704608', 'cui_str': 'Film'}]","[{'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C4721445', 'cui_str': 'Teasing'}]",,0.0220831,"For girls and boys aged 7-10, all three animations immediately improved state body satisfaction (+boys aged 11-14; Cohen's ds = .60-.71) and led to sustained improvements in trait media literacy (+girls aged 11-14; ds = .38-.61), sensitivity to appearance teasing (+boys aged 11-14; ds = .35-.48), and willingness to ignore appearance teasing (7-10 years only; ds = .34-.74) at one-week follow-up.","[{'ForeName': 'Emily L', 'Initials': 'EL', 'LastName': 'Matheson', 'Affiliation': 'Centre for Appearance Research, Department of Health and Social Sciences, University of the West of England, Coldharbour Lane, Bristol, BS16 1QY, UK. Electronic address: emily.matheson@uwe.ac.uk.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Lewis-Smith', 'Affiliation': 'Centre for Appearance Research, Department of Health and Social Sciences, University of the West of England, Coldharbour Lane, Bristol, BS16 1QY, UK.'}, {'ForeName': 'Phillippa C', 'Initials': 'PC', 'LastName': 'Diedrichs', 'Affiliation': 'Centre for Appearance Research, Department of Health and Social Sciences, University of the West of England, Coldharbour Lane, Bristol, BS16 1QY, UK.'}]",Body image,['10.1016/j.bodyim.2020.08.015']
3403,33050340,Feasibility and Safety of Transcranial Direct Current Stimulation in an Outpatient Rehabilitation Setting After Stroke.,"Transcranial direct current stimulation (tDCS) has strong potential for outpatient clinical use, but feasibility and safety of tDCS has only been evaluated in laboratory and inpatient clinical settings. The objective of this study was to assess feasibility and safety of tDCS for stroke in an outpatient clinical setting. Individuals with stroke in outpatient therapy received tDCS during physical therapy sessions. Feasibility was assessed with screening, enrollment, withdrawal, and adherence numbers, tDCS impressions, and perceived benefits and detriments of tDCS. Acute changes in fatigue and self-reported function and pre-post changes in fatigue were also assessed. Safety was assessed as adverse events and side effects. In total, 85 individuals were screened, and 10 were enrolled. Most exclusions were unrelated to clinical feasibility. In total, 3 participants withdrew, so 7 participants completed 2 sessions/week for 5-6 weeks with 100% adherence. In total, 71% reported positive impressions of tDCS. tDCS setup decreased to 5-7 min at end of study. There was one adverse event unrelated to tDCS. Mild to moderate side effects (tingling, itching, pinching, and fatigue) were experienced. In total, 86% of participants recounted benefits of tDCS. There were acute improvements in function and energy. Results support the feasibility and safety of tDCS in an outpatient clinical setting.",2020,There was one adverse event unrelated to tDCS.,"['Individuals with stroke in outpatient therapy received tDCS during physical therapy sessions', '85 individuals were screened, and 10 were enrolled', 'Outpatient Rehabilitation Setting After Stroke']","['Transcranial direct current stimulation (tDCS', 'Transcranial Direct Current Stimulation', 'tDCS']","['screening, enrollment, withdrawal, and adherence numbers, tDCS impressions, and perceived benefits and detriments of tDCS', 'positive impressions of tDCS', 'tDCS setup', 'Mild to moderate side effects (tingling, itching, pinching, and fatigue', 'fatigue and self-reported function and pre-post changes in fatigue', 'feasibility and safety', 'function and energy', 'adverse events and side effects']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0303135', 'cui_str': 'Beryllium-10'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0030554', 'cui_str': 'Paresthesia'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0418416', 'cui_str': 'Pinched'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",85.0,0.0441035,There was one adverse event unrelated to tDCS.,"[{'ForeName': 'Brice T', 'Initials': 'BT', 'LastName': 'Cleland', 'Affiliation': 'Brain Plasticity Lab, Department of Physical Therapy, College of Applied Health Sciences, University of Illinois at Chicago, Chicago, IL 60612, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Galick', 'Affiliation': 'Shirley Ryan AbilityLab DayRehab Center, Homewood, IL 60430, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Huckstep', 'Affiliation': 'Shirley Ryan AbilityLab DayRehab Center, Homewood, IL 60430, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Lenhart', 'Affiliation': 'Shirley Ryan AbilityLab DayRehab Center, Homewood, IL 60430, USA.'}, {'ForeName': 'Sangeetha', 'Initials': 'S', 'LastName': 'Madhavan', 'Affiliation': 'Brain Plasticity Lab, Department of Physical Therapy, College of Applied Health Sciences, University of Illinois at Chicago, Chicago, IL 60612, USA.'}]",Brain sciences,['10.3390/brainsci10100719']
3404,33052965,"The cost-effectiveness of MDMA-assisted psychotherapy for the treatment of chronic, treatment-resistant PTSD.","BACKGROUND


Chronic posttraumatic stress disorder (PTSD) is a disabling condition that generates considerable morbidity, mortality, and both medical and indirect social costs. Treatment options are limited. A novel therapy using 3,4-methylenedioxymethamphetamine (MDMA) has shown efficacy in six phase 2 trials. Its cost-effectiveness is unknown.
METHODS AND FINDINGS


To assess the cost-effectiveness of MDMA-assisted psychotherapy (MAP) from the health care payer's perspective, we constructed a decision-analytic Markov model to portray the costs and health benefits of treating patients with chronic, severe, or extreme, treatment-resistant PTSD with MAP. In six double-blind phase 2 trials, MAP consisted of a mean of 2.5 90-minute trauma-focused psychotherapy sessions before two 8-hour sessions with MDMA (mean dose of 125 mg), followed by a mean of 3.5 integration sessions for each active session. The control group received an inactive placebo or 25-40 mg. of MDMA, and otherwise followed the same regimen. Our model calculates net medical costs, mortality, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios. Efficacy was based on the pooled results of six randomized controlled phase 2 trials with 105 subjects; and a four-year follow-up of 19 subjects. Other inputs were based on published literature and on assumptions when data were unavailable. We modeled results over a 30-year analytic horizon and conducted extensive sensitivity analyses. Our model calculates expected medical costs, mortality, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratio. Future costs and QALYs were discounted at 3% per year. For 1,000 individuals, MAP generates discounted net savings of $103.2 million over 30 years while accruing 5,553 discounted QALYs, compared to continued standard of care. MAP breaks even on cost at 3.1 years while delivering 918 QALYs. Making the conservative assumption that benefits cease after one year, MAP would accrue net costs of $7.6 million while generating 288 QALYS, or $26,427 per QALY gained.
CONCLUSION


MAP provided to patients with severe or extreme, chronic PTSD appears to be cost-saving while delivering substantial clinical benefit. Third-party payers are likely to save money within three years by covering this form of therapy.",2020,"Our model calculates net medical costs, mortality, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios.","['patients with chronic, severe, or extreme, treatment-resistant PTSD with MAP', 'Chronic posttraumatic stress disorder (PTSD', '105 subjects; and a four-year follow-up of 19 subjects']","['MDMA-assisted psychotherapy', '3,4-methylenedioxymethamphetamine', 'MDMA-assisted psychotherapy (MAP', 'inactive placebo']","['medical costs, mortality, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratio', 'Efficacy', 'medical costs, mortality, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205403', 'cui_str': 'Extreme'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0115471', 'cui_str': 'Methylenedioxymethamphetamine'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0730525', 'cui_str': 'Chronic post-traumatic stress disorder'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0115471', 'cui_str': 'Methylenedioxymethamphetamine'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.0346378,"Our model calculates net medical costs, mortality, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios.","[{'ForeName': 'Elliot', 'Initials': 'E', 'LastName': 'Marseille', 'Affiliation': 'Health Strategies International, Oakland, California, United States of America.'}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Kahn', 'Affiliation': 'University of California, San Francisco, California, United States of America.'}, {'ForeName': 'Berra', 'Initials': 'B', 'LastName': 'Yazar-Klosinski', 'Affiliation': 'Multidisciplinary Association for Psychedelic Studies (MAPS), Santa Cruz, California, United States of America.'}, {'ForeName': 'Rick', 'Initials': 'R', 'LastName': 'Doblin', 'Affiliation': 'Multidisciplinary Association for Psychedelic Studies (MAPS), Santa Cruz, California, United States of America.'}]",PloS one,['10.1371/journal.pone.0239997']
3405,33053078,Effectiveness of ginger in reducing metabolic levels in people with diabetes: a randomized clinical trial.,"OBJECTIVE


to evaluate the effectiveness of ginge (Zingiber officinale) in reducing blood sugar and lipid levels in people with type 2 diabetes.
METHOD


a randomized and double-blind clinical trial conducted with people with type 2 diabetes in primary care facilities. The study included individuals aged between 20 and 80 years old, using oral antidiabetic drugs and with HbA1c levels between 6.0% and 10%. The participants were paired 1:1, allocated in two distinct groups, and randomized in blocks, based on their HbA1c levels. In the experimental group, the participants used 1.2g of ginger and, in the control group, 1.2g of placebo, daily for 90 days. The primary outcome was a reduction in fasting blood sugar and HbA1c, and the secondary outcome was a reduction in lipids and HOMA-IR. 103 individuals completed the study, 47 in the experimental group and 56 in the control group.
RESULTS


the participants in the experimental group showed a greater reduction in the blood glucose and total cholesterol values compared to the control group.
CONCLUSION


the use of ginger can help in the treatment of people with diabetes, and data support the inclusion of this herbal drug in the clinical practice of nurses. RBR-2rt2wy.",2020,"the participants in the experimental group showed a greater reduction in the blood glucose and total cholesterol values compared to the control group.
","['103 individuals completed the study, 47 in the experimental group and 56 in the control group', 'people with type 2 diabetes', 'people with type 2 diabetes in primary care facilities', 'individuals aged between 20 and 80 years old, using oral antidiabetic drugs and with HbA1c levels between 6.0% and 10', 'people with diabetes']","['placebo', 'ginger', 'ginge (Zingiber officinale']","['reduction in fasting blood sugar and HbA1c', 'blood glucose and total cholesterol values', 'lipids and HOMA-IR', 'blood sugar and lipid levels', 'metabolic levels']","[{'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1527415', 'cui_str': 'Oral route'}, {'cui': 'C0935929', 'cui_str': 'Antidiabetic agent'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0162751', 'cui_str': 'Ginger'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0428460', 'cui_str': 'Lipid level - finding'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",103.0,0.172749,"the participants in the experimental group showed a greater reduction in the blood glucose and total cholesterol values compared to the control group.
","[{'ForeName': 'Gerdane Celene Nunes', 'Initials': 'GCN', 'LastName': 'Carvalho', 'Affiliation': 'Universidade Estadual do Piauí, Departamento de Enfermagem, Picos, PI, Brazil.'}, {'ForeName': 'José Claudio Garcia', 'Initials': 'JCG', 'LastName': 'Lira-Neto', 'Affiliation': 'Universidade Federal do Ceará, Departamento de Enfermagem, Fortaleza, CE, Brazil.'}, {'ForeName': 'Márcio Flávio Moura de', 'Initials': 'MFM', 'LastName': 'Araújo', 'Affiliation': 'Fundação Oswaldo Cruz, Saúde Pública, Eusébio, CE, Brazil.'}, {'ForeName': 'Roberto Wagner Júnior Freire de', 'Initials': 'RWJF', 'LastName': 'Freitas', 'Affiliation': 'Fundação Oswaldo Cruz, Saúde Pública, Eusébio, CE, Brazil.'}, {'ForeName': 'Maria Lúcia', 'Initials': 'ML', 'LastName': 'Zanetti', 'Affiliation': 'Universidade de São Paulo, Escola de Enfermagem de Ribeirão Preto, PAHO/WHO Collaborating Centre for Nursing Research Development, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Marta Maria Coelho', 'Initials': 'MMC', 'LastName': 'Damasceno', 'Affiliation': 'Universidade Federal do Ceará, Departamento de Enfermagem, Fortaleza, CE, Brazil.'}]",Revista latino-americana de enfermagem,['10.1590/1518-8345.3870.3369']
3406,33053113,Effects of the prophylactic use of escitalopram on the prognosis and the plasma copeptin level in patients with acute cerebral infarction.,"This study aimed to investigate whether the routine administration of escitalopram for three months would improve the prognosis of patients with ischemic stroke and decrease the plasma copeptin level. A total of 97 patients with acute cerebral infarction were randomly allocated to receive escitalopram (5-10 mg once per day, orally; n=49) or not to receive escitalopram (control group; n=48) for 12 weeks starting at 2-7 days after the onset of stroke. Both groups received conventional treatments, including physiotherapy and secondary prevention of stroke. The National Institutes of Health Stroke Scale (NIHSS) score was used to evaluate the disability of patients at the initial evaluation and at the monthly follow-up visits for three months. Impairment in the daily activities was assessed using the Barthel Index (BI), while cognitive impairment was assessed using Mini-Mental State Examination (MMSE) score. The psychiatric assessment included the administration of the Present State Examination modified to identify Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) symptoms of depression. The severity of depression was measured using the 17-item Hamilton Rating Scale for Depression (HAMD). During the 3-month follow-up period, 95 patients were included in the analysis (two patients withdrew from the escitalopram group). NIHSS and BI improvement at the 90th day were significantly greater in the escitalopram group (P<0.05), while HAMD and plasma copeptin levels significantly decreased, compared to the control group (P<0.01). In patients with acute ischemic stroke, the earlier administration of escitalopram for three months may improve neurological functional prognosis and decrease copeptin level.",2020,"NIHSS and BI improvement at the 90th day were significantly greater in the escitalopram group (P<0.05), while HAMD and plasma copeptin levels significantly decreased, compared to the control group (P<0.01).","['97 patients with acute cerebral infarction', 'patients with ischemic stroke', 'patients with acute cerebral infarction', 'patients with acute ischemic stroke']","['escitalopram (5-10 mg once per day, orally; n=49) or not to receive escitalopram', 'escitalopram']","['Barthel Index (BI), while cognitive impairment was assessed using Mini-Mental State Examination (MMSE) score', 'Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) symptoms of depression', 'severity of depression', 'neurological functional prognosis and decrease copeptin level', 'Health Stroke Scale (NIHSS) score', 'NIHSS and BI improvement', '17-item Hamilton Rating Scale for Depression (HAMD', 'plasma copeptin level', 'HAMD and plasma copeptin levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0007785', 'cui_str': 'Cerebral infarction'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}]","[{'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1136324', 'cui_str': 'Diagnostic and Statistical Manual of Mental Disorders'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0033325', 'cui_str': 'Determination of prognosis'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0056279', 'cui_str': 'copeptins'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}]",97.0,0.0563996,"NIHSS and BI improvement at the 90th day were significantly greater in the escitalopram group (P<0.05), while HAMD and plasma copeptin levels significantly decreased, compared to the control group (P<0.01).","[{'ForeName': 'Jin-Xia', 'Initials': 'JX', 'LastName': 'Cao', 'Affiliation': ""Department of Neuropsychiatry, The Second People's Hospital of Lianyungang, Lianyungang, Jiangsu, China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': ""Department of Neuropsychiatry, The Second People's Hospital of Lianyungang, Lianyungang, Jiangsu, China.""}, {'ForeName': 'Yun-Tao', 'Initials': 'YT', 'LastName': 'Sun', 'Affiliation': ""Department of Neuropsychiatry, The Second People's Hospital of Lianyungang, Lianyungang, Jiangsu, China.""}, {'ForeName': 'Qing-Hong', 'Initials': 'QH', 'LastName': 'Zeng', 'Affiliation': ""Department of Neurology, The Second People's Hospital of Lianyungang, Lianyungang, Jiangsu, China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Department of Laboratory, The Second People's Hospital of Lianyungang, Lianyungang, Jiangsu, China.""}, {'ForeName': 'Jie-Chun', 'Initials': 'JC', 'LastName': 'Chen', 'Affiliation': ""Department of Neurology, The Second People's Hospital of Lianyungang, Lianyungang, Jiangsu, China.""}]",Brazilian journal of medical and biological research = Revista brasileira de pesquisas medicas e biologicas,['10.1590/1414-431X20208930']
3407,33053116,A novel stem cell therapy for hepatitis B virus-related acute-on-chronic liver failure.,"The aim of this study was to propose a stem cell therapy for hepatitis B virus (HBV)-related acute-on-chronic liver failure (ACLF) based on plasma exchange (PE) for peripheral blood stem cell (PBSC) collection and examine its safety and efficacy. Sixty patients (n=20 in each group) were randomized to PE (PE alone), granulocyte colony-stimulating factor (G-CSF) (PE after G-CSF treatment), and PBSC transplantation (PBSCT) (G-CSF, PE, PBSC collection and hepatic artery injection) groups. Patients were followed-up for 24 weeks. Liver function and adverse events were recorded. Survival analysis was performed. PBSCT improved blood ammonia levels at 1 week (P<0.05). The level of total bilirubin, international normalized ratio, and creatinine showed significant differences in the 4th week of treatment (P<0.05). The survival rates of the PE, G-CSF, and PBSCT groups were 50, 65, and 85% at 90 days (P=0.034). There was a significant difference in 90-day survival between the PE and PBSCT groups (P=0.021). The preliminary results suggested that PBSCT was safe, with a possibility of improved 90-day survival in patients with HBV-ACLF.",2020,There was a significant difference in 90-day survival between the PE and PBSCT groups (P=0.021).,"['patients with HBV-ACLF', 'Sixty patients (n=20 in each group', 'hepatitis B virus-related acute-on-chronic liver failure', 'hepatitis B virus (HBV)-related acute-on-chronic liver failure (ACLF']","['PE (PE alone), granulocyte colony-stimulating factor (G-CSF) (PE after G-CSF treatment), and PBSC transplantation (PBSCT', 'PBSCT']","['survival rates', 'blood ammonia levels', 'Liver function and adverse events', '90-day survival', 'level of total bilirubin, international normalized ratio, and creatinine']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019169', 'cui_str': 'Hepatitis B Virus'}, {'cui': 'C3850141', 'cui_str': 'Acute on chronic liver failure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0032113', 'cui_str': 'Plasma exchange'}, {'cui': 'C0079459', 'cui_str': 'Colony-stimulating factor, granulocytic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242602', 'cui_str': 'Peripheral blood stem cell graft'}]","[{'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0428437', 'cui_str': 'Blood ammonia measurement'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin'}, {'cui': 'C0525032', 'cui_str': 'International normalized ratio'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}]",,0.070712,There was a significant difference in 90-day survival between the PE and PBSCT groups (P=0.021).,"[{'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Zhu', 'Affiliation': 'Medical School of Chinese PLA, Beijing, China.'}, {'ForeName': 'Shaoli', 'Initials': 'S', 'LastName': 'You', 'Affiliation': 'Liver Failure Treatment and Research Center, Fifth Medical Center of Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Yihui', 'Initials': 'Y', 'LastName': 'Rong', 'Affiliation': 'Department of Infection and Liver Diseases, Peking University International Hospital, Beijing, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Yu', 'Affiliation': 'Department of Interventional Therapy, Fifth Medical Center of Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Sa', 'Initials': 'S', 'LastName': 'Lv', 'Affiliation': 'Liver Failure Treatment and Research Center, Fifth Medical Center of Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Fangjiao', 'Initials': 'F', 'LastName': 'Song', 'Affiliation': 'Liver Failure Treatment and Research Center, Fifth Medical Center of Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Hongling', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Liver Transplantation Center, Fifth Medical Center of Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Huaming', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Interventional Therapy, Fifth Medical Center of Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Liver Failure Treatment and Research Center, Fifth Medical Center of Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Dongze', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': 'Liver Failure Treatment and Research Center, Fifth Medical Center of Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Wanshu', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'Liver Failure Treatment and Research Center, Fifth Medical Center of Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Shaojie', 'Initials': 'S', 'LastName': 'Xin', 'Affiliation': 'Medical School of Chinese PLA, Beijing, China.'}]",Brazilian journal of medical and biological research = Revista brasileira de pesquisas medicas e biologicas,['10.1590/1414-431X20209728']
3408,33053953,"Decision-Making Visual Aids for Late, Imaging-Guided Endovascular Thrombectomy for Acute Ischemic Stroke.","BACKGROUND AND PURPOSE


Speedy decision-making is important for optimal outcomes from endovascular thrombectomy (EVT) for acute ischemic stroke (AIS). Figural decision aids facilitate rapid review of treatment benefits and harms, but have not yet been developed for late-presenting patients selected for EVT based on multimodal computed tomography or magnetic resonance imaging.
METHODS


For combined pooled study-level randomized trial (DAWN and DEFUSE 3) data, as well as each trial singly, 100 person-icon arrays (Kuiper-Marshall personographs) were generated showing beneficial and adverse effects of EVT for patients with AIS and large vessel occlusion using automated (algorithmic) and expert-guided joint outcome table specification.
RESULTS


Among imaging-selected patients 6 to 24 hours from last known well, for the full 7-category modified Rankin Scale (mRS), EVT had number needed to treat to benefit 1.9 (interquartile range [IQR], 1.9 to 2.1) and number needed to harm 40.0 (IQR, 29.2 to 58.3). Visual displays of treatment effects among 100 patients showed that, with EVT: 52 patients have better disability outcome, including 32 more achieving functional independence (mRS 0 to 2); three patients have worse disability outcome, including one more experiencing severe disability or death (mRS 5 to 6), mediated by symptomatic intracranial hemorrhage and infarct in new territory. Similar features were present in person-icon figures based on a 6-level mRS (levels 5 and 6 combined) rather than 7-level mRS, and based on the DAWN trial alone and DEFUSE 3 trial alone.
CONCLUSIONS


Personograph visual decision aids are now available to rapidly educate patients, family, and healthcare providers regarding benefits and risks of EVT for late-presenting, imaging-selected AIS patients.",2020,"RESULTS


Among imaging-selected patients","['100 patients', '100 person-icon arrays (Kuiper-Marshall personographs', 'patients with AIS and large vessel occlusion using automated (algorithmic) and expert-guided joint outcome table specification', 'Acute Ischemic Stroke']",['endovascular thrombectomy (EVT'],"['symptomatic intracranial hemorrhage and infarct in new territory', 'disability outcome', 'severe disability or death']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0243020', 'cui_str': 'Immunoconjugate'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0225990', 'cui_str': 'Large blood vessel structure'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0039224', 'cui_str': 'Table'}]","[{'cui': 'C0162578', 'cui_str': 'Removal of thrombus'}]","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0151699', 'cui_str': 'Intracranial hemorrhage'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0524613', 'cui_str': 'New Territories'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.207436,"RESULTS


Among imaging-selected patients","[{'ForeName': 'Pouria', 'Initials': 'P', 'LastName': 'Moshayedi', 'Affiliation': 'Department of Neurology and Comprehensive Stroke Center, University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Liebeskind', 'Affiliation': 'Department of Neurology and Comprehensive Stroke Center, University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Ashutosh', 'Initials': 'A', 'LastName': 'Jadhav', 'Affiliation': 'Department of Neurology, University of Pittsburgh Medical Center, Pittsburgh, PA, USA.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Jahan', 'Affiliation': 'Department of Radiology and Comprehensive Stroke Center, University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Maarten', 'Initials': 'M', 'LastName': 'Lansberg', 'Affiliation': 'Department of Neurology, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Latisha', 'Initials': 'L', 'LastName': 'Sharma', 'Affiliation': 'Department of Neurology and Comprehensive Stroke Center, University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Raul G', 'Initials': 'RG', 'LastName': 'Nogueira', 'Affiliation': 'Department of Neurology, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Saver', 'Affiliation': 'Department of Neurology and Comprehensive Stroke Center, University of California Los Angeles, Los Angeles, CA, USA.'}]",Journal of stroke,['10.5853/jos.2019.03503']
3409,33061926,Interpersonal Psychotherapy as a Single Treatment for Borderline Personality Disorder: A Pilot Randomized-Controlled Study.,"Recent guidelines share the recommendations that psychotherapy plays a central role in the treatment of borderline personality disorder (BPD). In recent years, interpersonal psychotherapy adapted for treating BPD (IPT-BPD) was added to specific psychotherapies and was tested in combination with pharmacotherapy. The present study is aimed to assess the efficacy of IPT-BPD revised (IPT-BPD-R) as single treatment in a sample of BPD patients. Results obtained in a group of patients receiving IPT-BPD-R were compared with those observed in a control group in waiting list plus clinical management (WL/CM). Forty-three BPD subjects were randomly allocated to one of the two arms. Patients were assessed at baseline and after 10 months with the following assessment instruments: Clinical Global Impression Scale, Severity item (CGI-S), Social Occupational Functioning Assessment Scale (SOFAS), Borderline Personality Disorder Severity Index (BPDSI), Barratt Impulsiveness Scale, version 11 (BIS-11), Modified Overt Aggression Scale (MOAS), and Self Harm Inventory (SHI). Statistical analysis was performed with one-way analysis of variance (ANOVA) or chi-square test to compare baseline characteristics of the two treatment groups. Comparison of score changes at the end of the trial between the two groups was calculated for each rating scale with the analysis of variance for repeated measures. Seven patients (16.3%) discontinued the treatment in the first month of the trial for non-adherence. We found a significant effect within subjects (trial duration) for all rating scales, except for the MOAS. A significant effect between subjects (treatment modality) was found for CGI-S; SOFAS; BIS-11 total score and subscale ""non-planning impulsivity""; BPDSI total score and items ""interpersonal relationships,"" ""impulsivity,"" and ""identity."" So, results showed differences between groups in favor of psychotherapy in terms of reduction of severity of general psychopathology, improvement of social and occupational functioning, and decrease of global BPD symptoms and three specific domains. On the other hand, we did not find any differences between groups for self-harm behaviors and aggressive behaviors.",2020,"A significant effect between subjects (treatment modality) was found for CGI-S; SOFAS; BIS-11 total score and subscale ""non-planning impulsivity""; BPDSI total score and items ""interpersonal relationships,"" ""impulsivity,"" and ""identity.""","['a sample of BPD patients', 'Forty-three BPD subjects', 'Borderline Personality Disorder']","['IPT-BPD revised (IPT-BPD-R', 'Interpersonal Psychotherapy']","['CGI-S; SOFAS; BIS-11 total score and subscale ""non-planning impulsivity""; BPDSI total score and items ""interpersonal relationships,"" ""impulsivity,"" and ""identity', 'Clinical Global Impression Scale, Severity item (CGI-S), Social Occupational Functioning Assessment Scale (SOFAS), Borderline Personality Disorder Severity Index (BPDSI), Barratt Impulsiveness Scale, version 11 (BIS-11), Modified Overt Aggression Scale (MOAS), and Self Harm Inventory (SHI', 'severity of general psychopathology, improvement of social and occupational functioning', 'global BPD symptoms']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0006012', 'cui_str': 'Borderline personality disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0450368', 'cui_str': '43'}]","[{'cui': 'C0380193', 'cui_str': 'iodine-123-IPT'}, {'cui': 'C0006012', 'cui_str': 'Borderline personality disorder'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0871787', 'cui_str': 'Interpersonal psychotherapy'}]","[{'cui': 'C3639708', 'cui_str': 'Clinical global impression scale'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0521127', 'cui_str': 'Occupational'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0564567', 'cui_str': 'Impulsive character'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0021125', 'cui_str': 'Impulsive behaviour'}, {'cui': 'C0006012', 'cui_str': 'Borderline personality disorder'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0424215', 'cui_str': 'Sense of identity'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0085271', 'cui_str': 'Self-injurious behavior'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",43.0,0.0263036,"A significant effect between subjects (treatment modality) was found for CGI-S; SOFAS; BIS-11 total score and subscale ""non-planning impulsivity""; BPDSI total score and items ""interpersonal relationships,"" ""impulsivity,"" and ""identity.""","[{'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Bozzatello', 'Affiliation': 'Department of Neuroscience, University of Turin, Turin, Italy.'}, {'ForeName': 'Silvio', 'Initials': 'S', 'LastName': 'Bellino', 'Affiliation': 'Department of Neuroscience, University of Turin, Turin, Italy.'}]",Frontiers in psychiatry,['10.3389/fpsyt.2020.578910']
3410,33061961,"Novel Pathologic Factors for Risk Stratification of Gastric ""Indefinite for Dysplasia"" Lesions.","Methods


In total, 123 IND cases with final diagnoses of cancer (29.3%), high-grade dysplasia (6.5%), low-grade dysplasia (11.4%), and nonneoplasm (52.8%) were randomly divided into test set ( n  = 27) and validation set ( n  = 96). By the image analysis, size, pleomorphism, hyperchromasia, irregularity of nuclei, and ratios of structural atypia area (SAA) to total IND area were measured in the test set. Using the validation set, consensus meetings were held for the evaluation of pathologic factors that predict the final diagnosis.
Results


By image analysis, the only ratio of SAA to total IND area was associated with the final diagnosis ( p  < 0.001). In the consensus meeting for validation, the nuclear factors, except loss of nuclear polarity ( p  = 0.004-0.026), could not predict the final diagnosis. Conversely, most structural factors could predict the final diagnosis. In particular, SAA > 25% was the most powerful predictive factor. We proposed criteria of risk stratification by using SAA > 25%, loss of surface maturation (LOSM), and loss of nuclear polarity (LONP) (Malignancy rate; Category 0: SAA ≤ 25% without LOSM and LONP; 0%, Category 1: SAA ≤ 25% with any of LOSM or LONP; 15.2%-16.7%, Category 2: SAA > 25% without LOSM and LONP; 44.4%-50.0%, Category 3: SAA > 25% with any of LOSM or LONP 54.5%-55.6%).
Conclusions


Structural atypia was more helpful than nuclear atypia and SAA > 25% was the most powerful predictor for the diagnosis of INDs of the stomach. We propose shortening the follow-up period to six months for Category 1, endoscopic resection for Category 2 and 3, postresection follow-up periods of one year for Category 2, and six months for Category 3.",2020,"In the consensus meeting for validation, the nuclear factors, except loss of nuclear polarity ( p  = 0.004-0.026), could not predict the final diagnosis.","['In total, 123 IND cases with final diagnoses of cancer (29.3%), high-grade dysplasia (6.5%), low-grade dysplasia (11.4%), and nonneoplasm (52.8']",[],"['loss of surface maturation (LOSM), and loss of nuclear polarity (LONP', 'size, pleomorphism, hyperchromasia, irregularity of nuclei, and ratios of structural atypia area (SAA) to total IND area']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0013230', 'cui_str': 'Investigational New Drugs'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0332144', 'cui_str': 'Final diagnosis (discharge)'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0334044', 'cui_str': 'Dysplasia'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C1962916', 'cui_str': 'Low grade (lymphoma)'}, {'cui': 'C4517533', 'cui_str': '11.4'}]",[],"[{'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0032219', 'cui_str': 'Pleomorphism'}, {'cui': 'C0333910', 'cui_str': 'Hyperchromatism'}, {'cui': 'C0007610', 'cui_str': 'Nucleus'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0013230', 'cui_str': 'Investigational New Drugs'}]",123.0,0.0310418,"In the consensus meeting for validation, the nuclear factors, except loss of nuclear polarity ( p  = 0.004-0.026), could not predict the final diagnosis.","[{'ForeName': 'Kwangil', 'Initials': 'K', 'LastName': 'Yim', 'Affiliation': ""Department of Hospital Pathology, Uijeongbu St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Jung Ha', 'Initials': 'JH', 'LastName': 'Shin', 'Affiliation': ""Department of Hospital Pathology, Eunpyeong St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Jinyoung', 'Initials': 'J', 'LastName': 'Yoo', 'Affiliation': ""Department of Hospital Pathology, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}]",Gastroenterology research and practice,['10.1155/2020/9460681']
3411,33062008,Efficacy of Electroacupuncture Combined with Auricular Point Pressing in Improving Mental Well-Being among Individuals with Heroin Use Disorder: A Randomized Controlled Crossover Trial and Pilot Study.,"Objective


To evaluate the clinical efficacy of combining electroacupuncture with auricular point pressing in improving quality of life of individuals with heroin use disorder undergoing methadone maintenance treatment.
Design


A randomized controlled crossover trial.
Subjects


50 participants were recruited from Taipei City Hospital, Linsen Chinese Medicine and Kunming branches, and randomly allocated to treatment groups.
Method


The 36-Item Short Form Health Survey (SF-36) was used. Group A received electroacupuncture at the  Hegu  (LI4) and  Zusanli  (ST36) and auricular point pressing on Ear  Shenmen , and Group B received only auricular point pressing on Ear  Shenmen  biweekly for 4 weeks. After a 1-week washout period, crossover of the groups was performed.
Results


The SF-36 mental component scores of the combined treatment group improved relative to the single treatment group (11.09 vs. 10.33,  p =0.023). Methadone dosage was reduced in both groups (combined therapy group: 8.58 ± 4.17/7.76 ± 4.11 (baseline/posttreatment) vs. single therapy group: 8.36 ± 4.20/8.30 ± .28,  p =0.001).
Conclusion


Combined therapy of high-frequency electroacupuncture with auricular point pressing had better efficacy in enhancing quality of life, especially for mental well-being, and in gradually reducing methadone dosage.",2020,"The SF-36 mental component scores of the combined treatment group improved relative to the single treatment group (11.09 vs. 10.33,  p =0.023).","['Individuals with Heroin Use Disorder', 'individuals with heroin use disorder undergoing methadone maintenance treatment', 'Subjects\n\n\n50 participants were recruited from Taipei City Hospital, Linsen Chinese Medicine and Kunming branches']","['Methadone', 'electroacupuncture at the  Hegu  (LI4) and  Zusanli  (ST36) and auricular point pressing on Ear  Shenmen , and Group B received only auricular point pressing on Ear  Shenmen  biweekly for 4 weeks', 'electroacupuncture with auricular point pressing', 'Electroacupuncture Combined with Auricular Point']","['SF-36 mental component scores', 'quality of life', 'enhancing quality of life']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011892', 'cui_str': 'Heroin'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0588202', 'cui_str': 'Drug addiction therapy - methadone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0020029', 'cui_str': 'Urban Hospitals'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0445517', 'cui_str': 'Kunming'}, {'cui': 'C0205384', 'cui_str': 'Branching'}]","[{'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C1522191', 'cui_str': 'Otic route'}, {'cui': 'C0013443', 'cui_str': 'Ear structure'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",50.0,0.0695117,"The SF-36 mental component scores of the combined treatment group improved relative to the single treatment group (11.09 vs. 10.33,  p =0.023).","[{'ForeName': 'Kai-Chiang', 'Initials': 'KC', 'LastName': 'Yu', 'Affiliation': 'Department of Chinese Medicine, Taipei City Hospital, Linsen Chinese Medicine and Kunming Branch, Taipei, Taiwan.'}, {'ForeName': 'Han-Ting', 'Initials': 'HT', 'LastName': 'Wei', 'Affiliation': 'Department of Psychiatry, Taipei City Hospital, Linsen Chinese Medicine and Kunming Branch, Taipei, Taiwan.'}, {'ForeName': 'Shang-Chih', 'Initials': 'SC', 'LastName': 'Chang', 'Affiliation': 'Department of Chinese Medicine, Taipei City Hospital, Linsen Chinese Medicine and Kunming Branch, Taipei, Taiwan.'}, {'ForeName': 'Chung-Hua', 'Initials': 'CH', 'LastName': 'Hsu', 'Affiliation': 'Department of Chinese Medicine, Taipei City Hospital, Linsen Chinese Medicine and Kunming Branch, Taipei, Taiwan.'}]",Evidence-based complementary and alternative medicine : eCAM,['10.1155/2020/3748056']
3412,33062044,A randomized controlled trial to assess the effectiveness and safety of acupuncture for overactive bladder: a study in Hong Kong population.,"Background


Around 15% of the Hong Kong population was found to suffer from overactive bladder (OAB), but the current available treatments, such as medication, behavioral therapy and physical therapy are unsatisfactory. Previous studies have suggested that acupuncture may have promising effect for OAB, but some limitations on the study design render the evidence questionable. This study aimed to evaluate the effectiveness and safety of acupuncture treatment for patients with OAB in Hong Kong.
Methods


One hundred patients with OAB were enrolled. The patients were randomized to receive either active acupuncture or sham needle intervention twice a week for 8 consecutive weeks, and had a follow-up consultation 12 weeks after the completion of acupuncture intervention. The primary outcome assessment was the 3-Day Voiding Diary, which records daytime and night-time urinary frequency and symptoms, at the baseline, the end of the 8-week intervention and 12 weeks after acupuncture intervention. Secondary outcomes included Urine NGF level, Incontinence Impact Questionnaire (IIQ-7) and Urogenital Distress Inventory (UDI-6), as well as Overactive Bladder Symptom Score (OABSS).
Results


After 16 sessions of treatment, when compared with the baseline, both active and sham acupuncture significantly reduced the frequency of urgency urinary incontinence (UUI), daytime and night-time urinary frequency as well as the scores of IIQ-7, UDI-6 and OABSS. Moreover, the treatment effects could last for at least 3 months. However, no significant difference in frequency of UUI and daytime urinary frequency was found between the active and sham acupuncture groups. On the other hand, the night-time urinary frequency decreased more significantly during the treatment and follow-up in the active acupuncture group than in the sham control group after controlling baseline night-time urinary frequency. Urine NGF level could not be detected by ELISA method in our experiments.
Conclusion


This study suggests a beneficial effect of acupuncture on improving OAB symptoms. Both active and sham acupuncture treatment were able to improve the symptoms of frequency of urgency urinary incontinence, and the daytime and night-time urinary frequency, while only mild adverse effects were found. This project was unable to establish the specific effect of acupuncture for OAB. Trial registration  Chinese Clinical Trial Registry, ChiCTR-INR-16010048. Registered on 29 Nov 2016.",2020,"However, no significant difference in frequency of UUI and daytime urinary frequency was found between the active and sham acupuncture groups.","['patients with OAB in Hong Kong', 'One hundred patients with OAB were enrolled', 'Hong Kong population']","['active acupuncture or sham needle intervention', 'acupuncture', 'acupuncture intervention']","['3-Day Voiding Diary, which records daytime and night-time urinary frequency and symptoms', 'night-time urinary frequency', 'symptoms of frequency of urgency urinary incontinence, and the daytime and night-time urinary frequency', 'effectiveness and safety', 'frequency of urgency urinary incontinence (UUI), daytime and night-time urinary frequency as well as the scores of IIQ-7, UDI-6 and OABSS', 'Urine NGF level', 'OAB symptoms', 'frequency of UUI and daytime urinary frequency', 'Urine NGF level, Incontinence Impact Questionnaire (IIQ-7) and Urogenital Distress Inventory (UDI-6), as well as Overactive Bladder Symptom Score (OABSS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0042023', 'cui_str': 'Increased frequency of urination'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0085606', 'cui_str': 'Urgent desire to urinate'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0027752', 'cui_str': 'Nerve Growth Factor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0042066', 'cui_str': 'Structure of genitourinary system'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",100.0,0.0900942,"However, no significant difference in frequency of UUI and daytime urinary frequency was found between the active and sham acupuncture groups.","[{'ForeName': 'Zhi-Xiu', 'Initials': 'ZX', 'LastName': 'Lin', 'Affiliation': 'School of Chinese Medicine, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong SAR China.'}, {'ForeName': 'Ngai Ho Tony', 'Initials': 'NHT', 'LastName': 'Chan', 'Affiliation': 'Department of Medicine & Geriatrics, Pok Oi Hospital, Yuen Long, N.T., Hong Kong SAR China.'}, {'ForeName': 'Yiu-Keung', 'Initials': 'YK', 'LastName': 'Kwan', 'Affiliation': 'Department of Medicine & Geriatrics, Tuen Mun Hospital, Tuen Mun, N.T., Hong Kong SAR China.'}, {'ForeName': 'Yu Tat', 'Initials': 'YT', 'LastName': 'Chan', 'Affiliation': 'School of Chinese Medicine, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong SAR China.'}, {'ForeName': 'Hongwei', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'School of Chinese Medicine, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong SAR China.'}, {'ForeName': 'Kam-Yuk Sylvia', 'Initials': 'KS', 'LastName': 'Tam', 'Affiliation': 'Yan Oi Tong - The Chinese University of Hong Kong Chinese Medicine Centre for Training & Research, Tuen Mun, N.T., Hong Kong, SAR China.'}, {'ForeName': 'Mei Kwan', 'Initials': 'MK', 'LastName': 'Lai', 'Affiliation': 'School of Chinese Medicine, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong SAR China.'}, {'ForeName': 'Chun-Kam', 'Initials': 'CK', 'LastName': 'Lee', 'Affiliation': 'School of Chinese Medicine, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong SAR China.'}, {'ForeName': 'Kit', 'Initials': 'K', 'LastName': 'Ngan', 'Affiliation': 'School of Chinese Medicine, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong SAR China.'}, {'ForeName': 'Stella Yin Yuen', 'Initials': 'SYY', 'LastName': 'Tsoi', 'Affiliation': 'Yan Oi Tong - The Chinese University of Hong Kong Chinese Medicine Centre for Training & Research, Tuen Mun, N.T., Hong Kong, SAR China.'}, {'ForeName': 'Yiu Wa', 'Initials': 'YW', 'LastName': 'Lau', 'Affiliation': 'Yan Oi Tong - The Chinese University of Hong Kong Chinese Medicine Centre for Training & Research, Tuen Mun, N.T., Hong Kong, SAR China.'}, {'ForeName': 'Yan-Fang', 'Initials': 'YF', 'LastName': 'Xian', 'Affiliation': 'School of Chinese Medicine, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong SAR China.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Ching', 'Affiliation': 'Hong Kong Institute of Integrative Medicine, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong SAR China.'}, {'ForeName': 'Yuanqi', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Pok Oi Hospital - The Chinese University of Hong Kong Chinese Medicine Centre for Training & Research, Shatin, N.T., Hong Kong SAR China.'}]",Chinese medicine,['10.1186/s13020-020-00388-w']
3413,33058901,Virtual and real-life ostracism and its impact on a subsequent acute stressor.,"While ostracism constitutes a social stressor with negative effects on physical and mental health, social inclusion seems to increase resilience. This may be true not only for face-to-face settings, but also for computer-mediated interactions. Hence, this study examined the differences between ostracism and social inclusion in real-life or Virtual Reality (VR) regarding self-reported stress, neuroendocrine and cardiovascular reactivity in a subsequent real-life socio-evaluative task. 84 females were randomly assigned to a 3 (agency: face-to-face/human controlled VR-avatar/computer VR-agent) x 2 (inclusion status: inclusion/exclusion) between-subject design using a Cyberball paradigm. Subsequently, they were exposed to a real-life Trier Social Stress Test (TSST). Results indicate that the experience of ostracism constitutes a threat to fundamental social needs independent of agency. Excluded participants showed cardiovascular reactivity during TSST; also face-to-face and avatar excluded individuals had elevated salivary cortisol levels. Included participants reported more perceived social support during Cyberball and showed a blunted cortisol response to the TSST. These results suggest that face-to-face and avatar-related ostracism provokes responses in the hypothalamic-pituitary-adrenal (HPA) axis and the sympathetic nervous system (SNS). Furthermore, they reveal that social inclusion may act as a stress-protector as it alters HPA- and SNS-related stress responsiveness to subsequent stressors.",2020,Excluded participants showed cardiovascular reactivity during TSST; also face-to-face and avatar excluded individuals had elevated salivary cortisol levels.,['84 females'],['3 (agency: face-to-face/human controlled VR-avatar/computer VR-agent) x 2 (inclusion status: inclusion/exclusion) between-subject design using a Cyberball paradigm'],"['cardiovascular reactivity', 'elevated salivary cortisol levels', 'perceived social support', 'blunted cortisol response']","[{'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C1997138', 'cui_str': 'Blunted'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}]",84.0,0.0106574,Excluded participants showed cardiovascular reactivity during TSST; also face-to-face and avatar excluded individuals had elevated salivary cortisol levels.,"[{'ForeName': 'Oswald D', 'Initials': 'OD', 'LastName': 'Kothgassner', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Medical University of Vienna, Vienna, Austria; Department of Clinical and Health Psychology, Faculty of Psychology, University of Vienna, Vienna, Austria.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Goreis', 'Affiliation': 'Department of Clinical and Health Psychology, Faculty of Psychology, University of Vienna, Vienna, Austria; Outpatient Unit for Research, Teaching and Practice, Faculty of Psychology, University of Vienna, Vienna, Austria.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Glenk', 'Affiliation': 'Department of Comparative Medicine, Messerli Research Institute, University of Veterinary Medicine Vienna, Medical University Vienna and University, Vienna, Austria.'}, {'ForeName': 'Johanna Xenia', 'Initials': 'JX', 'LastName': 'Kafka', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Leon', 'Initials': 'L', 'LastName': 'Beutl', 'Affiliation': 'Working Group Entertainment Computing, University of Vienna, Vienna, Austria.'}, {'ForeName': 'Ilse', 'Initials': 'I', 'LastName': 'Kryspin-Exner', 'Affiliation': 'Department of Clinical and Health Psychology, Faculty of Psychology, University of Vienna, Vienna, Austria.'}, {'ForeName': 'Helmut', 'Initials': 'H', 'LastName': 'Hlavacs', 'Affiliation': 'Working Group Entertainment Computing, University of Vienna, Vienna, Austria.'}, {'ForeName': 'Rupert', 'Initials': 'R', 'LastName': 'Palme', 'Affiliation': 'Department of Biomedical Sciences, University of Veterinary Medicine, Vienna, Austria.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Felnhofer', 'Affiliation': 'Department of Clinical and Health Psychology, Faculty of Psychology, University of Vienna, Vienna, Austria; Department of Pediatrics and Adolescent Medicine, Medical University of Vienna, Vienna, Austria. Electronic address: anna.felnhofer@meduniwien.ac.at.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113205']
3414,33059233,Transverse abdominis activity and ultrasound biofeedback in college golfers with and without low back pain.,"OBJECTIVES


To compare transverse abdominis (TrA) muscle activity in college golfers with and without a history of low back pain (LBP) and examine the effects of ultrasound biofeedback and a functional golf-setup position on TrA activity.
DESIGN


Crossover study.
SETTING


Laboratory.
PARTICIPANTS


Thirty-two (n = 32) collegiate golfers were stratified into either the LBP group (n = 16, 4.6 ± 4.5 LBP episodes) or non-LBP group (n = 16, 0.1 ± 0.3 LBP episodes) based on LBP episodes in the last 6-months.
MAIN OUTCOME MEASURES


Ultrasound measures of TrA activity were performed during standard contractions and contractions with ultrasound biofeedback. Contraction-type order was randomized between two visits. Testing was performed in two positions, supine and golf-setup positions.
RESULTS


We observed no significant differences in TrA activity between the LBP and non-LBP groups. Overall, TrA activity was greater during biofeedback contractions compared to standard contractions, and TrA activity was lower in the golf-setup position compared to the supine position.
CONCLUSIONS


We observed no differences in TrA activity between college golfers with and without LBP. College golfers with and without LBP demonstrated a greater ability to contract their TrA with real-time ultrasound biofeedback and a lower ability to contract their TrA in the functional golf-setup position compared to the traditional supine position.",2020,College golfers with and without LBP demonstrated a greater ability to contract their TrA with real-time ultrasound biofeedback and a lower ability to contract their TrA in the functional golf-setup position compared to the traditional supine position.,"['college golfers with and without low back pain', 'Thirty-two (n\xa0=\xa032) collegiate golfers', 'college golfers with and without a history of low back pain (LBP']","['ultrasound biofeedback and a functional golf-setup position', 'LBP', 'LBP episodes) or non-LBP']","['Transverse abdominis activity and ultrasound biofeedback', 'standard contractions and contractions with ultrasound biofeedback', 'Overall, TrA activity', 'transverse abdominis (TrA) muscle activity', 'TrA activity']","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0262926', 'cui_str': 'History of'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0018041', 'cui_str': 'Golfing'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}]","[{'cui': 'C0205106', 'cui_str': 'Transverse plane'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}]",32.0,0.02025,College golfers with and without LBP demonstrated a greater ability to contract their TrA with real-time ultrasound biofeedback and a lower ability to contract their TrA in the functional golf-setup position compared to the traditional supine position.,"[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Skibski', 'Affiliation': 'Department of Exercise Science & Athletic Training, Adrian College, Adrian, MI, USA. Electronic address: askibski19@adrian.edu.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Burkholder', 'Affiliation': 'Department of Exercise Science & Athletic Training, Adrian College, Adrian, MI, USA. Electronic address: eburkholder@adrian.edu.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Goetschius', 'Affiliation': 'Department of Health Professions, James Madison University, Harrisonburg, VA, USA. Electronic address: goetscjw@jmu.edu.'}]",Physical therapy in sport : official journal of the Association of Chartered Physiotherapists in Sports Medicine,['10.1016/j.ptsp.2020.10.004']
3415,33059293,"A novel diclofenac gel (AMZ001) applied once or twice daily in subjects with painful knee osteoarthritis: A randomized, placebo-controlled clinical trial.","PURPOSE


Osteoarthritis Research Society International (OARSI) Expert Consensus Guidelines recommend topical non-steroidal anti-inflammatory drugs as first-line medications for osteoarthritis (OA) knee pain, but several voluminous daily applications are required to achieve efficacy. There is a need to develop new and improved topical analgesics with a faster onset, longer duration of action, and the requirement to apply less gel. This trial investigated the safety and efficacy of a new 3.06% diclofenac gel (AMZ001) in subjects with knee OA.
METHODS


In total, 444 subjects (AMZ001 twice daily (BID) [n = 121], AMZ001 once daily (QD) + placebo QD [n = 121], placebo BID [n = 121], or Voltaren 1% 4-times daily [n = 81]) were enrolled. All except Voltaren 1% (single-blinded) were applied topically in a double-blind manner for a total of 4-weeks. The primary endpoint was the change from baseline to week 4 in the WOMAC pain sub-score in the target knee. Secondary and exploratory endpoints included additional efficacy measures (WOMAC total score, WOMAC function and stiffness sub-scores, WOMAC pain weight-bearing and non-weight-bearing sub-scores, ICOAP, chair-stand test, OMERACT-OARSI responder rate, PGA, WPAI, EQ-5D, rescue medication use, satisfaction questionnaire) and safety.
RESULTS


Treatment with AMZ001 QD was effective at reducing WOMAC pain sub-scores vs placebo (estimated treatment difference [ETD]: -4.61 [95% confidence interval (CI): -9.09, -0.12]; p = 0.0440); however, BID application was not (ETD: -3.76 [95% CI: -8.21, 0.68]; p = 0.0969). For several secondary endpoints, changes from baseline to week 4 conferred nominally statistically significant improvements in favor of AMZ001 vs placebo, including PGA score (AMZ001 BID vs placebo, ETD: -0.61 [95% CI: -1.11, -0.11]; p = 0.0162; AMZ001 QD vs placebo, ETD: -0.63 [95% CI: -1.13, -0.13]; p = 0.0134), WPAI overall work impairment score (AMZ001 QD vs placebo, ETD: -10.44 [95% CI: -20.84, -0.04]; p = 0.0492), and EQ-5D VAS score (AMZ001 BID vs placebo, ETD: 4.70 [95% CI: 0.55, 8.85]; p = 0.0264). Post-hoc analysis excluding 11-14 subjects per group with pain scores that decreased between screening and baseline suggests a consistent effect of both AMZ001 QD (ETD: -5.84 [95% CI: -10.71, -0.97]; p = 0.0189) and BID (ETD: -5.35 [95% CI: -10.16, -0.54]; p = 0.0292) in reducing WOMAC pain sub-scores vs placebo. In general, treatment satisfaction was high, as measured by the satisfaction questionnaire. The frequency and incidence of adverse events (AEs) was greatest in the placebo group. Most AEs (>99%) were of mild or moderate severity. There were no serious AEs. There were no notable effects of any treatment on vital signs, ECGs, physical examination findings, or other laboratory assessments.
CONCLUSIONS


Treatment with AMZ001 BID for 4 weeks improved WOMAC pain sub-scores; however, only QD application conferred nominally statistically significant improvements vs placebo. AMZ001 was generally well tolerated.",2020,"There were no notable effects of any treatment on vital signs, ECGs, physical examination findings, or other laboratory assessments.
","['subjects with knee OA', 'subjects with painful knee osteoarthritis']","['placebo BID [n\xa0=\xa0121], or Voltaren 1% 4-times daily [n\xa0=\xa081', 'AMZ001 once daily (QD)\xa0+\xa0placebo QD', 'placebo, ETD', 'placebo', 'diclofenac gel (AMZ001', 'AMZ001 BID', 'AMZ001 QD', 'AMZ001 QD (ETD']","['PGA score', 'additional efficacy measures (WOMAC total score, WOMAC function and stiffness sub-scores, WOMAC pain weight-bearing and non-weight-bearing sub-scores, ICOAP, chair-stand test, OMERACT-OARSI responder rate, PGA, WPAI, EQ-5D, rescue medication use, satisfaction questionnaire) and safety', 'WOMAC pain sub-scores', 'safety and efficacy', 'EQ-5D VAS score', 'frequency and incidence of adverse events (AEs', 'WPAI overall work impairment score', 'vital signs, ECGs, physical examination findings, or other laboratory assessments', 'WOMAC pain sub-score', 'tolerated', 'pain scores']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0048106', 'cui_str': ""4-benzamido-4'-isothiocyanostilbene-2,2'-disulfonate""}, {'cui': 'C0699958', 'cui_str': 'Voltaren'}, {'cui': 'C0585291', 'cui_str': 'Four times daily'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0012091', 'cui_str': 'Diclofenac'}, {'cui': 'C0017243', 'cui_str': 'Gel'}]","[{'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0085086', 'cui_str': 'Weight-bearing'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",444.0,0.649854,"There were no notable effects of any treatment on vital signs, ECGs, physical examination findings, or other laboratory assessments.
","[{'ForeName': 'Asger Reinstrup', 'Initials': 'AR', 'LastName': 'Bihlet', 'Affiliation': 'Nordic Bioscience Clinical Development, Denmark. Electronic address: abi@nordicbio.com.'}, {'ForeName': 'Inger', 'Initials': 'I', 'LastName': 'Byrjalsen', 'Affiliation': 'Nordic Bioscience Clinical Development, Denmark.'}, {'ForeName': 'Lee S', 'Initials': 'LS', 'LastName': 'Simon', 'Affiliation': 'SDG LLC, Cambridge, Massachusetts, United States.'}, {'ForeName': 'Dario', 'Initials': 'D', 'LastName': 'Carrara', 'Affiliation': 'Amzell B.V., Hoofddorp, the Netherlands.'}, {'ForeName': 'Laetitia', 'Initials': 'L', 'LastName': 'Delpy', 'Affiliation': 'Amzell B.V., Hoofddorp, the Netherlands.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Derne', 'Affiliation': 'Amzell B.V., Hoofddorp, the Netherlands.'}]",Seminars in arthritis and rheumatism,['10.1016/j.semarthrit.2020.09.007']
3416,33059317,How to introduce a rotigotine patch to Parkinson's disease patients taking oral dopamine agonists.,"OBJECTIVE


Ways of introducing a rotigotine patch to Parkinson disease (PD) patients include initial induction for dopamine agonist (DA)-free patients and overnight switch (OS), cross-titration (CT), and add-on (AO) for patients already taking oral DAs. We investigated whether or not the introductions method affects the continuation rate of rotigotine patch.
METHODS


The subjects were 188 PD patients who started using a rotigotine patch at the Department of Neurology, Fukuoka University Hospital. The rate of successful continuation of rotigotine patch for one year after initiation and the reasons for discontinuation were investigated; for the patients who discontinued due to poor efficacy, the DA dose before and after the start of rotigotine patch treatment was determined.
RESULTS


The 1-year continuation rates were 38.5 % (20/52) in the OS group, 61.5 % (8/13) in the CT group, 35.3 % (6/17) in the AO group, and 50.9 % (54/106) in the de novo group. The most common reason for discontinuation in all groups was skin reactions. Compared with the de novo group, only the OS group had a significantly higher discontinuation rate due to poor efficacy (3.8 % vs. 21.2 %, P <  0.001). However, in the OS group, the continuation rate in the subjects with an increased total DA dose, after rotigotine was introduced, was significantly higher than that in the subjects with a decreased total DA dose (p = 0.031).
CONCLUSION


The use of a rotigotine patch with an equivalent dose should be considered when switching from oral DAs, and appropriate care should be administered for any skin reactions. The present findings suggested that not the introduction method but the use of an equivalent dose between DA formulations might affect the continuation rate of rotigotine patch.",2020,"The 1-year continuation rates were 38.5 % (20/52) in the OS group, 61.5 % (8/13) in the CT group, 35.3 % (6/17) in the AO group, and 50.9 % (54/106) in the de novo group.","['patients already taking oral DAs', '188 PD patients who started using a rotigotine patch at the Department of Neurology, Fukuoka University Hospital', ""Parkinson's disease patients taking oral dopamine agonists""]","['dopamine agonist (DA)-free patients and overnight switch (OS), cross-titration (CT', 'rotigotine patch']","['continuation rate of rotigotine patch', 'rate of successful continuation of rotigotine patch', 'continuation rate', 'discontinuation rate', '1-year continuation rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0051767', 'cui_str': 'amsonic acid'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C1700683', 'cui_str': 'Rotigotine'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0178601', 'cui_str': 'Dopamine receptor agonist'}]","[{'cui': 'C0178601', 'cui_str': 'Dopamine receptor agonist'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439583', 'cui_str': 'Overnight'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}, {'cui': 'C1700683', 'cui_str': 'Rotigotine'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}]","[{'cui': 'C1700683', 'cui_str': 'Rotigotine'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0439234', 'cui_str': 'year'}]",188.0,0.0281234,"The 1-year continuation rates were 38.5 % (20/52) in the OS group, 61.5 % (8/13) in the CT group, 35.3 % (6/17) in the AO group, and 50.9 % (54/106) in the de novo group.","[{'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Yasutaka', 'Affiliation': 'Department of Pharmaceutical and Health Care Management, Faculty of Pharmaceutical Science, Fukuoka University, Japan; Department of Hospital Pharmacy, Fukuoka University Hospital, Japan.'}, {'ForeName': 'Shinsuke', 'Initials': 'S', 'LastName': 'Fujioka', 'Affiliation': 'Department of Neurology, Faculty of Medicine, Fukuoka University, Japan. Electronic address: shinsuke@cis.fukuoka-u.ac.jp.'}, {'ForeName': 'Takayasu', 'Initials': 'T', 'LastName': 'Mishima', 'Affiliation': 'Department of Neurology, Faculty of Medicine, Fukuoka University, Japan.'}, {'ForeName': 'Hirotomo', 'Initials': 'H', 'LastName': 'Shibaguchi', 'Affiliation': 'Department of Hospital Pharmacy, Fukuoka University Hospital, Japan.'}, {'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Tsuboi', 'Affiliation': 'Department of Neurology, Faculty of Medicine, Fukuoka University, Japan.'}, {'ForeName': 'Hidetoshi', 'Initials': 'H', 'LastName': 'Kamimura', 'Affiliation': 'Department of Pharmaceutical and Health Care Management, Faculty of Pharmaceutical Science, Fukuoka University, Japan; Department of Hospital Pharmacy, Fukuoka University Hospital, Japan.'}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2020.106266']
3417,33064609,"Comparison of isoflurane, sevoflurane, and desflurane as inhalant anesthetics in prairie rattlesnakes ( Crotalus viridis ).","OBJECTIVE


To characterize induction and recovery characteristics of 3 commonly used inhalant anesthetics in prairie rattlesnakes ( Crotalus viridis ): isoflurane, sevoflurane, and desflurane.
ANIMALS


12 healthy adult prairie rattlesnakes.
PROCEDURES


In a randomized crossover design, snakes underwent anesthetic induction with 5% isoflurane, 8% sevoflurane, or 18% desflurane, with a washout period of ≥ 7 days between anesthetic events. Anesthetic depth parameters were recorded throughout induction and recovery, including time to loss and return of righting reflex, muscle tone, ability to intubate, response to pressure, and time to return to spontaneous respiration. Every 5 minutes throughout the anesthetic procedures, heart rate, respiratory rate, and percentage expired anesthetic gas were recorded.
RESULTS


No snakes died during the study. Sevoflurane anesthesia resulted in anesthetic gas avoidance behavior in snakes during induction and had the significantly longest recovery time to extubation and time to return of pressure response, compared with the other inhalant anesthetics. Anesthesia with isoflurane resulted in a significantly longer time to return of righting reflex, compared with sevoflurane or desflurane. No significant difference was noted in time to loss of pressure response among the 3 anesthetic gases. Desflurane anesthesia resulted in the significantly quickest loss of righting reflex among the anesthetic protocols; despite this, 4 of 12 desflurane anesthetized snakes did not achieve an anesthetic plane deep enough for intubation.
CONCLUSIONS AND CLINICAL RELEVANCE


Isoflurane and sevoflurane, but not desflurane, inhalation anesthesia resulted in consistent and predictable loss of righting reflex and induction of anesthesia deep enough to allow intubation in snakes.",2020,"Anesthesia with isoflurane resulted in a significantly longer time to return of righting reflex, compared with sevoflurane or desflurane.","['prairie rattlesnakes ( Crotalus viridis ', '12 healthy adult prairie rattlesnakes']","['isoflurane, sevoflurane, and desflurane', 'Sevoflurane anesthesia', 'isoflurane', 'inhalation anesthesia', 'Desflurane anesthesia', 'desflurane', 'anesthetic induction with 5% isoflurane, 8% sevoflurane, or 18% desflurane', 'sevoflurane']","['anesthetic gas avoidance behavior', 'time to loss of pressure response', 'longer time to return of righting reflex', 'time to loss and return of righting reflex, muscle tone, ability to intubate, response to pressure, and time to return to spontaneous respiration', 'quickest loss of righting reflex', 'heart rate, respiratory rate, and percentage expired anesthetic gas']","[{'cui': 'C0327530', 'cui_str': 'Crotalus confluentus'}, {'cui': 'C0327541', 'cui_str': 'Crotalus viridis'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0022180', 'cui_str': 'Isoflurane'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0063252', 'cui_str': 'desflurane'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0002917', 'cui_str': 'Anesthesia, Inhalation'}, {'cui': 'C0853212', 'cui_str': 'Induction of anaesthesia'}]","[{'cui': 'C0242902', 'cui_str': 'Anesthetic Gases'}, {'cui': 'C0178494', 'cui_str': 'Avoidance behavior'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0234156', 'cui_str': 'Static reflex of Magnus and de Kleijn'}, {'cui': 'C0026841', 'cui_str': 'Muscle Tension'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0412771', 'cui_str': 'Spontaneous respiration'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",12.0,0.035472,"Anesthesia with isoflurane resulted in a significantly longer time to return of righting reflex, compared with sevoflurane or desflurane.","[{'ForeName': 'Lauren P', 'Initials': 'LP', 'LastName': 'Kane', 'Affiliation': ''}, {'ForeName': 'Sathya K', 'Initials': 'SK', 'LastName': 'Chinnadurai', 'Affiliation': ''}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Vivirito', 'Affiliation': ''}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Strahl-Heldreth', 'Affiliation': ''}, {'ForeName': 'Matthew C', 'Initials': 'MC', 'LastName': 'Allender', 'Affiliation': ''}]",Journal of the American Veterinary Medical Association,['10.2460/javma.257.9.945']
3418,33064669,Pre-operative tranexemic acid vs. etamsylate in reducing blood loss during elective cesarean section: randomized controlled trial.,"Objectives To investigate whether etamsylate may be an alternative to tranexamic acid in reduction of blood loss during elective cesarean section. Methods Prospective double-blinded multi-center randomized controlled trial involving 180 qualified women equally divided into three groups each containing 60 women received either tranexamic acid, etamsylate or placebo 20 min before elective cesarean section and blood loss was estimated. Results Mean blood loss, cases needing blood transfusion and cases needing further interventions were significantly lower in tranexamic acid and etamsylate group than placebo group, while mean postoperative hemoglobin and hematocrite were significantly higher in both tranexamic acid and etamsylate as compared to placebo. Conclusions Etamsylate is an effective second-line therapy (after tranexamic acid) in reducing blood loss during elective cesarean section with low risk of side effects, therefore, it can be an effective alternative to tranexamic acid in cases with contraindications or anticipated to be at high-risk of developing side effects from tranexamic acid.",2020,"Results Mean blood loss, cases needing blood transfusion and cases needing further interventions were significantly lower in tranexamic acid and etamsylate group than placebo group, while mean postoperative hemoglobin and hematocrite were significantly higher in both tranexamic acid and etamsylate as compared to placebo.","['180 qualified women equally divided into three groups each containing 60 women received either', 'elective cesarean section']","['Pre-operative tranexemic acid vs. etamsylate', 'placebo', 'tranexamic acid', 'tranexamic acid, etamsylate or placebo']","['Mean blood loss, cases needing blood transfusion and cases needing further interventions', 'blood loss', 'mean postoperative hemoglobin and hematocrite']","[{'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0014968', 'cui_str': 'Ethamsylate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}]",180.0,0.260152,"Results Mean blood loss, cases needing blood transfusion and cases needing further interventions were significantly lower in tranexamic acid and etamsylate group than placebo group, while mean postoperative hemoglobin and hematocrite were significantly higher in both tranexamic acid and etamsylate as compared to placebo.","[{'ForeName': 'Haitham', 'Initials': 'H', 'LastName': 'Torky', 'Affiliation': 'Department of Obstetrics and Gynecology, October 6th University, Giza, Egypt.'}, {'ForeName': 'El-Sayed', 'Initials': 'ES', 'LastName': 'El-Desouky', 'Affiliation': 'Department of Obstetrics and Gynecology, Al-Azhar University, Cairo, Egypt.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Abo-Elmagd', 'Affiliation': 'Department of Obstetrics and Gynecology, Al-Azhar University, Cairo, Egypt.'}, {'ForeName': 'Attia', 'Initials': 'A', 'LastName': 'Mohamed', 'Affiliation': 'Department of Obstetrics and Gynecology, Al-Azhar University, Cairo, Egypt.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Abdalhamid', 'Affiliation': 'Department of Obstetrics and Gynecology, Al-Azhar University, Assuit, Egypt.'}, {'ForeName': 'Ashraf', 'Initials': 'A', 'LastName': 'El-Shahat', 'Affiliation': 'Department of Obstetrics and Gynecology, Al-Azhar University, Cairo, Egypt.'}, {'ForeName': 'Sileem', 'Initials': 'S', 'LastName': 'Ahmed Sileem', 'Affiliation': 'Department of Obstetrics and Gynecology, Al-Azhar University, Assuit, Egypt.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Tawfik', 'Affiliation': 'Department of Microbiology, Faculty of Pharmacy Al-Azhar University, Cairo, Egypt.'}, {'ForeName': 'Ashraf', 'Initials': 'A', 'LastName': 'Abo-Louz', 'Affiliation': 'Department of Obstetrics and Gynecology, October 6th University, Giza, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Hussein', 'Affiliation': 'Department of Obstetrics and Gynecology, October 6th University, Giza, Egypt.'}]",Journal of perinatal medicine,['10.1515/jpm-2020-0271']
3419,33064711,"Pregabalin as a premedication for anxiety in patients undergoing plastic surgery: randomized double-blind, placebo-controlled study.","Objective


To evaluate the usefulness of premedication with 75 mg pregabalin orally to reduce the degree of preoperative anxiety in patients scheduled for plastic surgery procedures.
Method


A controlled randomized double-blind clinical trial that analyzed two groups of patients: 75 mg pregabalin tablet (Pg) against placebo tablet (Pl). Efficacy was assessed using the visual anxiety scale (VAS) with two measurements, the first without medication and the second 70 minutes after the drug was taken.
Results


One hundred patients were evaluated, fifty received pregabalin and fifty placebo, baseline VAS score showed an general average of 4.6 ± 1.9 points, significantly higher in the Pg group (Pg 5.2 ± 2.1 points vs 4.1 ± 1.6 points Pl; p = 0.0035). The VAS score after premedication was 3.9 ± 2.1 points, significantly lower in the Pg group (Pg 3.2 ± 1.6 points vs 4.6 ± 2.3 Pl points, p = 0.0006).
Conclusion


Premedication 75 mg pregabalin orally decreases the degree of preoperative anxiety in adult patients scheduled for plastic surgery procedures.",2020,"The VAS score after premedication was 3.9 ± 2.1 points, significantly lower in the Pg group (Pg 3.2 ± 1.6 points vs 4.6 ± 2.3 Pl points, p = 0.0006).
","['patients undergoing plastic surgery', 'patients scheduled for plastic surgery procedures', 'One hundred patients', 'adult patients scheduled for plastic surgery procedures']","['pregabalin tablet (Pg) against placebo tablet (Pl', 'pregabalin', 'placebo', 'pregabalin and fifty placebo', 'Pregabalin']","['baseline VAS score', 'visual anxiety scale (VAS', 'VAS score', 'Efficacy', 'degree of preoperative anxiety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038911', 'cui_str': 'Plastic surgery - specialty'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0677616', 'cui_str': 'Plastic operation'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0657912', 'cui_str': 'pregabalin'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}]",100.0,0.401957,"The VAS score after premedication was 3.9 ± 2.1 points, significantly lower in the Pg group (Pg 3.2 ± 1.6 points vs 4.6 ± 2.3 Pl points, p = 0.0006).
","[{'ForeName': 'Ludivina A', 'Initials': 'LA', 'LastName': 'Cortés-Martínez', 'Affiliation': 'Departamento de Anestesiología, Hospital Ángeles Lomas, Ciudad de México.'}, {'ForeName': 'Luis E', 'Initials': 'LE', 'LastName': 'Cardoso-García', 'Affiliation': 'Departamento de Anestesiología, Hospital Ángeles Lomas, Ciudad de México.'}, {'ForeName': 'Yazmin', 'Initials': 'Y', 'LastName': 'Galván-Talamantes', 'Affiliation': 'Departamento de Anestesiología, Hospital Ángeles Lomas, Ciudad de México.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Morales-Maza', 'Affiliation': 'Departamento de Cirugía, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Ciudad de México.'}, {'ForeName': 'Mario A', 'Initials': 'MA', 'LastName': 'Rosas-Sánchez', 'Affiliation': 'Centro Oncológico Estatal Instituto de Seguridad Social del Estado de México y Municipios, Toluca, Estado de México. México.'}, {'ForeName': 'Dulce M', 'Initials': 'DM', 'LastName': 'Vargas-Aguilar', 'Affiliation': 'Departamento de Anestesiología, Hospital Ángeles Lomas, Ciudad de México.'}, {'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Bañuelos-Ortiz', 'Affiliation': 'Departamento de Anestesiología, Hospital Ángeles Lomas, Ciudad de México.'}, {'ForeName': 'Gerardo E', 'Initials': 'GE', 'LastName': 'Álvarez-Reséndiz', 'Affiliation': 'Departamento de Anestesiología, Hospital Ángeles Lomas, Ciudad de México.'}]",Cirugia y cirujanos,['10.24875/CIRU.20001684']
3420,33065060,Effects of canagliflozin on anaemia in patients with type 2 diabetes and chronic kidney disease: a post-hoc analysis from the CREDENCE trial.,"BACKGROUND


Sodium-glucose co-transporter 2 inhibitors might enhance erythropoiesis and increase red blood cell mass. We assessed the long-term effects of canagliflozin on anaemia-related outcomes.
METHODS


In a post-hoc analysis of the Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation (CREDENCE) trial, we included patients with type 2 diabetes and chronic kidney disease who were randomly assigned to treatment with canagliflozin or placebo at 690 sites in 34 countries. We assessed the effects of canagliflozin versus matched placebo on haemoglobin and haematocrit using linear mixed-effects models. The primary outcome of this post-hoc analysis was a composite outcome of investigator-reported anaemia or treatment for anaemia, which was assessed using Kaplan-Meier analysis and Cox regression models. All analyses were done by intention to treat.
FINDINGS


Between March 24, 2014, and May 5, 2017, 4401 participants were randomly assigned to receive canagliflozin (100 mg; n=2202) or placebo (n=2199). At baseline, mean haemoglobin concentration was 132·0 g/L (SD 17·7), 1599 (36%) of 4401 participants had anaemia (defined as haemoglobin <130 g/L in men or <120 g/L in women), and 33 (<1%) of 4401 participants used erythropoiesis-stimulating agents. During a median follow-up period of 2·6 years (IQR 2·1-3·1), mean haemoglobin concentration was 7·1 g/L (95% CI 6·4-7·8) higher and haematocrit was 2·4% (2·2-2·6) higher in the canagliflozin group than the placebo group. Overall, 573 of 4401 participants had either an investigator-reported anaemia event or initiation of treatment for anaemia: 358 (8%) of 4401 participants reported anaemia events, 343 (8%) initiated iron preparations, 141 (3%) initiated erythropoiesis-stimulating agents, and 114 (2%) received blood transfusion. The risk of the composite outcome of anaemia events or initiation of treatment for anaemia was lower in the canagliflozin group than the placebo group (hazard ratio 0·65, 95% CI 0·55-0·77; p<0·0001). Compared with the placebo group, participants in the canagliflozin group also had lower risks of anaemia events alone (0·58, 0·47-0·72; p<0·0001), initiation of iron preparations (0·64, 0·52-0·80; p<0·0001), and need for erythropoiesis-stimulating agents (0·65, 0·46-0·91; p=0·012).
INTERPRETATION


These data suggest that canagliflozin reduces the risk of anaemia-associated outcomes, including the need for erythropoiesis-stimulating agents, among patients with type 2 diabetes and chronic kidney disease.
FUNDING


Janssen Research and Development.",2020,"Compared with the placebo group, participants in the canagliflozin group also had lower risks of anaemia events alone (0·58, 0·47-0·72; p<0·0001), initiation of iron preparations (0·64, 0·52-0·80; p<0·0001), and need for erythropoiesis-stimulating agents (0·65, 0·46-0·91; p=0·012).
","['0·65', 'patients with type 2 diabetes and chronic kidney disease', 'Between March 24, 2014, and May 5, 2017, 4401 participants']","['canagliflozin', 'canagliflozin or placebo', 'placebo']","['haematocrit', 'lower risks of anaemia events', 'haemoglobin and haematocrit', 'composite outcome of investigator-reported anaemia or treatment for anaemia', 'anaemia', 'mean haemoglobin concentration', 'anaemia event or initiation of treatment for anaemia', 'blood transfusion', 'anaemia events or initiation of treatment for anaemia', 'anaemia events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C2974540', 'cui_str': 'canagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}]",4401.0,0.640331,"Compared with the placebo group, participants in the canagliflozin group also had lower risks of anaemia events alone (0·58, 0·47-0·72; p<0·0001), initiation of iron preparations (0·64, 0·52-0·80; p<0·0001), and need for erythropoiesis-stimulating agents (0·65, 0·46-0·91; p=0·012).
","[{'ForeName': 'Megumi', 'Initials': 'M', 'LastName': 'Oshima', 'Affiliation': 'Renal and Metabolic Division, The George Institute for Global Health, UNSW Sydney, Sydney, NSW, Australia; Department of Nephrology and Laboratory Medicine, Kanazawa University, Kanazawa, Japan.'}, {'ForeName': 'Brendon L', 'Initials': 'BL', 'LastName': 'Neuen', 'Affiliation': 'Renal and Metabolic Division, The George Institute for Global Health, UNSW Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Meg J', 'Initials': 'MJ', 'LastName': 'Jardine', 'Affiliation': 'Renal and Metabolic Division, The George Institute for Global Health, UNSW Sydney, Sydney, NSW, Australia; Concord Repatriation General Hospital, Sydney, NSW, Australia.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Bakris', 'Affiliation': 'Department of Medicine, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Edwards', 'Affiliation': 'Janssen Research and Development, Raritan, NJ, USA.'}, {'ForeName': 'Adeera', 'Initials': 'A', 'LastName': 'Levin', 'Affiliation': 'Division of Nephrology, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Kenneth W', 'Initials': 'KW', 'LastName': 'Mahaffey', 'Affiliation': 'School of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Neal', 'Affiliation': 'Renal and Metabolic Division, The George Institute for Global Health, UNSW Sydney, Sydney, NSW, Australia; The Charles Perkins Centre, University of Sydney, Sydney, NSW, Australia; Imperial College London, London, UK.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Pollock', 'Affiliation': 'Kolling Institute of Medical Research, Sydney Medical School, Sydney, NSW, Australia; Royal North Shore Hospital, Sydney, NSW, Australia.'}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Rosenthal', 'Affiliation': 'Janssen Research and Development, Raritan, NJ, USA.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Wada', 'Affiliation': 'Department of Nephrology and Laboratory Medicine, Kanazawa University, Kanazawa, Japan.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Wheeler', 'Affiliation': 'Renal and Metabolic Division, The George Institute for Global Health, UNSW Sydney, Sydney, NSW, Australia; Department of Renal Medicine, University College London, London, UK.'}, {'ForeName': 'Vlado', 'Initials': 'V', 'LastName': 'Perkovic', 'Affiliation': 'Renal and Metabolic Division, The George Institute for Global Health, UNSW Sydney, Sydney, NSW, Australia; Royal North Shore Hospital, Sydney, NSW, Australia.'}, {'ForeName': 'Hiddo J L', 'Initials': 'HJL', 'LastName': 'Heerspink', 'Affiliation': 'Renal and Metabolic Division, The George Institute for Global Health, UNSW Sydney, Sydney, NSW, Australia; Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, Netherlands. Electronic address: h.j.lambers.heerspink@umcg.nl.'}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(20)30300-4']
3421,33065070,SGLT2 inhibitors and thiazide enhance excretion of DEHP toxic metabolites in subjects with type 2 diabetes: A randomized clinical trial.,"OBJECTIVE


Phthalates are non-persistent pollutants related to impaired metabolism and high cardiovascular risk. Their toxic metabolites are eliminated through urine and feces. Prevention policies are considered by the governments, although no therapeutic strategy to facilitate their elimination from the human body has been proposed so far. Aim of the present study was to verify, for the first time in humans, whether diuretics might be able to enhance phthalates' toxic metabolites urinary output.
DESIGN AND METHODS


We conducted a two-armed, parallel-design, randomized clinical trial. Thirty patients with type 2 diabetes and hypertension received a four week-treatment with Dapagliflozin 10 mg or Hydrochlorothiazide 12.5 mg. 24-hours urine were collected to measure urinary excretion of three major 2-ethylhexyl-phthalate (DEHP) metabolites, i.e. mono 2-ethylhexyl phthalate (MEHP), mono-2-ethyl-5-oxohexyl phthalate (MEOHP) and mono 2-ethyl-5-hydroxyhexyl phthalate (MEHHP).
RESULTS


24-h urinary excretion of DEHP and MEHP was increased (+44%, p = 0.036; +49%, p = 0.0016) while MEOHP e MEHHP showed only a positive trend (+25%, p = 0.016; +36%, p = 0.062). Irrespective of the specific treatment, induced variations of daily urinary eliminations of MEHP metabolites were related with the 24-h urinary sodium (r = 0.42, p = 0.0226) and potassium (r = 0.54, p = 0.0026) excretion. Also, DEHP and MEOHP were related to sodium (r = 0·43, p = 0.0205; r = 0·44, p = 0.0168 respectively) but not to potassium.
CONCLUSIONS


Urinary phthalates excretion seems to occur mainly through sodium- and potassium-related mechanisms, apparently independent from the different diuretic effect. Both thiazide diuretics and SLGT2 inhibitors are effective into the removal of phthalates metabolites from the human body, reducing the human tissues' exposure to their toxicity.",2020,"RESULTS


24-hours urinary excretion of DEHP and MEHP was increased (+44%, p=0.036; +49%, p=0.0016) while MEOHP e MEHHP showed only a positive trend (+25%, p=0.016; +36%, p=0.062).","['Thirty patients with type 2 diabetes and hypertension', 'subjects with type 2 diabetes']","['SGLT2 inhibitors and thiazide', 'Dapaglifozin 10 mg or Hydrochlorothiazide', 'thiazide diuretics and SLGT2 inhibitors']","['DEHP toxic metabolites', '24-hours urinary excretion of DEHP and MEHP', 'DEHP and MEOHP', 'urinary excretion of three major 2-ethylhexyl-phthalate (DEHP) metabolites, i.e. mono 2-ethylhexyl phthalate (MEHP), mono-2-ethyl-5-oxohexyl phthalate (MEOHP) and mono 2-ethyl-5-hydroxyhexyl phthalate (MEHHP', '24-hour urinary sodium', 'daily urinary eliminations of MEHP metabolites']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]","[{'cui': 'C3273807', 'cui_str': 'SGLT2 Inhibitors'}, {'cui': 'C0012802', 'cui_str': 'Thiazide diuretic'}, {'cui': 'C0020261', 'cui_str': 'Hydrochlorothiazide'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0012197', 'cui_str': 'Di-2-ethylhexyl phthalate'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0021345', 'cui_str': 'Infectious mononucleosis'}, {'cui': 'C0220894', 'cui_str': 'Phthalic acid ester'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1320408', 'cui_str': 'Urinary elimination status'}]",30.0,0.0815342,"RESULTS


24-hours urinary excretion of DEHP and MEHP was increased (+44%, p=0.036; +49%, p=0.0016) while MEOHP e MEHHP showed only a positive trend (+25%, p=0.016; +36%, p=0.062).","[{'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Mengozzi', 'Affiliation': 'Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Fabrizia', 'Initials': 'F', 'LastName': 'Carli', 'Affiliation': 'Institute of Clinical Physiology, National Research Council, Pisa, Italy.'}, {'ForeName': 'Letizia', 'Initials': 'L', 'LastName': 'Guiducci', 'Affiliation': 'Institute of Clinical Physiology, National Research Council, Pisa, Italy.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Parolini', 'Affiliation': 'Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Edoardo', 'Initials': 'E', 'LastName': 'Biancalana', 'Affiliation': 'Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Amalia', 'Initials': 'A', 'LastName': 'Gastaldelli', 'Affiliation': 'Institute of Clinical Physiology, National Research Council, Pisa, Italy. Electronic address: amalia@ifc.cnr.it.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Solini', 'Affiliation': 'Department of Surgical, Medical, Molecular and Critical Area Pathology, University of Pisa, Pisa, Italy. Electronic address: anna.solini@med.unipi.it.'}]",Environmental research,['10.1016/j.envres.2020.110316']
3422,33065080,Safety and Efficacy of 1-Month Dual Antiplatelet Therapy (Ticagrelor + Aspirin) Followed by 23-Month Ticagrelor Monotherapy in Patients Undergoing Staged Percutaneous Coronary Intervention (A Sub-Study from GLOBAL LEADERS).,"Patients undergoing staged percutaneous coronary intervention (SPCI) are exposed to extended duration of antiplatelet therapy, and a novel aspirin-free antiplatelet regimen after SPCI should be specifically evaluated among these patients. This is a prespecified substudy of the GLOBAL LEADERS which is a randomized, open-label trial, comparing an experimental regimen of 1-month dual antiplatelet therapy (DAPT; ticagrelor and aspirin) followed by 23-month ticagrelor monotherapy to a reference regimen of 12-month DAPT followed by 12-month aspirin monotherapy. Patients were stratified according to whether or not SPCI was performed. The impact of the timing of SPCI on clinical outcomes was also investigated. Of 15,968 randomized patients, 1,651 patients underwent SPCI within 3 months. These patients with SPCI had a significantly higher risk of bleeding and ischemic endpoints than those without SPCI. In patients undergoing SPCI, the primary endpoint (composite of all-cause death or new Q-wave myocardial infarction at 2 years) and secondary safety endpoint (Bleeding Academic Research Consortium [BARC]-defined bleeding 3 or 5) were similar in the 2 regimens. However, in patients presenting with acute coronary syndrome (ACS), the experimental regimen reduced a risk of BARC 3 or 5 bleeding (1.8% vs 4.5%; HR 0.387; 95% CI 0.179 to 0.836; p = 0.016). In patients undergoing SPCI later than 10 days after index procedure, this risk reduction was still prominent (0.8% vs 2.3%; HR 0.321; 95% CI 0.116 to 0.891; p = 0.029). In conclusion, patients undergoing SPCI are at high risk and may need special attention from clinicians. In ACS patients undergoing SPCI, a novel aspirin-free antiplatelet regimen appears to be associated with a lower bleeding risk than with standard DAPT.",2020,"In ACS patients undergoing SPCI, a novel aspirin-free antiplatelet regimen appears to be associated with a lower bleeding risk than with standard DAPT.","['Patients Undergoing', 'patients presenting with acute coronary syndrome (ACS', 'Patients undergoing staged percutaneous coronary intervention (SPCI', '15,968 randomized patients, 1,651 patients underwent SPCI within 3 months']","['1-Month Dual Antiplatelet Therapy (Ticagrelor\u202f+\u202fAspirin', 'Ticagrelor Monotherapy', 'Staged Percutaneous Coronary Intervention', 'aspirin monotherapy', 'dual antiplatelet therapy (DAPT) (ticagrelor and aspirin']","['primary endpoint (composite of all-cause death or new Q-wave myocardial infarction at 2 years) and secondary safety endpoint (Bleeding Academic Research Consortium [BARC]-defined bleeding 3 or 5', 'risk of bleeding and ischemic endpoints', 'Safety and Efficacy', 'bleeding risk', 'risk of BARC 3 or 5 bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0429089', 'cui_str': 'Electrocardiogram Q waves'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",15968.0,0.031278,"In ACS patients undergoing SPCI, a novel aspirin-free antiplatelet regimen appears to be associated with a lower bleeding risk than with standard DAPT.","[{'ForeName': 'Hideyuki', 'Initials': 'H', 'LastName': 'Kawashima', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Heart Center; Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands; Department of Cardiology, National University of Ireland, Galway (NUIG), Galway, Ireland.'}, {'ForeName': 'Mariusz', 'Initials': 'M', 'LastName': 'Tomaniak', 'Affiliation': 'First Department of Cardiology, Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Ono', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Heart Center; Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands; Department of Cardiology, National University of Ireland, Galway (NUIG), Galway, Ireland.'}, {'ForeName': 'Rutao', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, National University of Ireland, Galway (NUIG), Galway, Ireland; Department of Cardiology, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Hironori', 'Initials': 'H', 'LastName': 'Hara', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Heart Center; Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Gao', 'Affiliation': 'Department of Cardiology, National University of Ireland, Galway (NUIG), Galway, Ireland; Department of Cardiology, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Kuniaki', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Heart Center; Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands.'}, {'ForeName': 'Faisal', 'Initials': 'F', 'LastName': 'Sharif', 'Affiliation': 'Department of Cardiology, National University of Ireland, Galway (NUIG), Galway, Ireland.'}, {'ForeName': 'Attila', 'Initials': 'A', 'LastName': 'Thury', 'Affiliation': 'Cardiology Centre, University of Szeged, Szeged, Hungary.'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Suryapranata', 'Affiliation': 'Department of Cardiology, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Walsh', 'Affiliation': 'Department of Cardiology Belfast Health & Social Care Trust, Belfast, United Kingdom.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Cotton', 'Affiliation': 'Heart and Lung Centre, New Cross Hospital, Wolverhampton, United Kingdom.'}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Carrie', 'Affiliation': 'Department of Cardiology, Rangueil Hospital, Paul Sabatier University Toulouse 3, Toulouse, France.'}, {'ForeName': 'Manel', 'Initials': 'M', 'LastName': 'Sabate', 'Affiliation': 'Clinic Hospital Barcelona, Barcelona, Spain.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Steinwender', 'Affiliation': 'Department of Cardiology Kepler University Hospital Linz Medical Faculty, Johannes Kepler University Linz, Linz, Austria.'}, {'ForeName': 'Gregor', 'Initials': 'G', 'LastName': 'Leibundgut', 'Affiliation': 'Department of Cardiology, Kantonsspital Baselland, Liestal, Switzerland.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Wykrzykowska', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Heart Center; Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands.'}, {'ForeName': 'Robbert J', 'Initials': 'RJ', 'LastName': 'de Winter', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Heart Center; Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands.'}, {'ForeName': 'Scot', 'Initials': 'S', 'LastName': 'Garg', 'Affiliation': 'Royal Blackburn Hospital, Blackburn, United Kingdom.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hamm', 'Affiliation': 'Kerckhoff Heart Center, Campus University of Giessen, Bad Nauheim, Germany.'}, {'ForeName': 'Philippe Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'Université Paris-Diderot, Hôpital Bichat, Assistance Publique-Hôpitaux de Paris, INSERM U-1148, FACT (French Alliance for Cardiovascular Trials), Paris, France; National Heart and Lung Institute, Royal Brompton Hospital, Imperial College, London, United Kingdom.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Jüni', 'Affiliation': ""Applied Health Research Centre, Li Ka Shing Knowledge Institute, St Michael's Hospital, Department of Medicine and Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Canada.""}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Vranckx', 'Affiliation': 'Jessa Ziekenhuis, Faculty of Medicine and Life Sciences at the Hasselt University, Hasselt, Belgium.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Valgimigli', 'Affiliation': 'Department of Cardiology, Bern University Hospital, Inselspital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': 'Department of Cardiology, Bern University Hospital, Inselspital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Onuma', 'Affiliation': 'Department of Cardiology, National University of Ireland, Galway (NUIG), Galway, Ireland.'}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': 'Department of Cardiology, National University of Ireland, Galway (NUIG), Galway, Ireland; NHLI, Imperial College London, London, United Kingdom. Electronic address: patrick.w.j.c.serruys@gmail.com.'}]",The American journal of cardiology,['10.1016/j.amjcard.2020.09.057']
3423,33065342,Ribociclib plus fulvestrant for advanced breast cancer: Health-related quality-of-life analyses from the MONALEESA-3 study.,"PURPOSE


In the MONALEESA-3 Phase III trial of patients with hormone receptor-positive human epidermal growth factor receptor-negative advanced breast cancer, ribociclib plus fulvestrant significantly improved progression-free survival (PFS) and overall survival (OS). Here, we present patient-reported outcomes from the trial, including health-related quality of life (HRQOL).
METHODS


Patients were randomized (2:1) to receive ribociclib plus fulvestrant or placebo plus fulvestrant. Time to definitive 10% deterioration (TTD) from baseline in HRQOL (global health status [GHS] from the EORTC QLQ-C30 questionnaire) and pain (BPI-SF questionnaire) were assessed using Kaplan-Meier estimates; a stratified Cox regression model was used to estimate the hazard ratio (HR) and 95% CIs.
RESULTS


Deterioration ≥10% in the EORTC-QLQ-C30 GHS was observed in 33% of patients in the ribociclib group vs 34% of patients in the placebo (reference) group (HR for TTD ≥ 10% = 0.81 [95% CI, 0.62-1.1]). Similar findings were noted for TTD ≥5% (HR = 0.79 [95% CI, 0.61-1.0]) and TTD ≥15% (HR = 0.81 [95% CI, 0.60-1.08]). TTD ≥10% in emotional functioning (HR = 0.76 [95% CI, 0.57-1.01]) trended in favor of the ribociclib group, whereas results for fatigue and pain were similar between arms. TTD ≥10% in BPI-SF pain severity index score (HR = 0.77 [95% CI, 0.57-1.05]) and worst pain item score (HR = 0.81 [95% CI, 0.58-1.12]) trended in favor of ribociclib vs placebo.
CONCLUSIONS


In addition to significantly prolonging PFS and OS compared with placebo plus fulvestrant, adding ribociclib to fulvestrant maintains HRQOL.",2020,"RESULTS


Deterioration ≥10% in the EORTC-QLQ-C30 GHS was observed in 33% of patients in the ribociclib group vs 34% of patients in the placebo (reference) group (","['Patients', 'reference) group ', 'advanced breast cancer', 'patients with hormone receptor-positive human epidermal growth factor receptor-negative advanced breast cancer']","['ribociclib plus fulvestrant or placebo plus fulvestrant', 'Ribociclib plus fulvestrant', 'placebo', 'ribociclib plus fulvestrant', 'ribociclib', 'placebo plus fulvestrant']","['worst pain item score', 'progression-free survival (PFS) and overall survival (OS', 'BPI-SF pain severity index score', 'Time to definitive 10% deterioration (TTD) from baseline in HRQOL (global health status [GHS] from the EORTC QLQ-C30 questionnaire) and pain (BPI-SF questionnaire', 'health-related quality of life (HRQOL', 'fatigue and pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C4087185', 'cui_str': 'Human epidermal growth factor receptor negative'}]","[{'cui': 'C4045494', 'cui_str': 'ribociclib'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0935916', 'cui_str': 'fulvestrant'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0559741', 'cui_str': 'Item score'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0443196', 'cui_str': 'Definitive'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",,0.436342,"RESULTS


Deterioration ≥10% in the EORTC-QLQ-C30 GHS was observed in 33% of patients in the ribociclib group vs 34% of patients in the placebo (reference) group (","[{'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Fasching', 'Affiliation': 'University Hospital Erlangen, Comprehensive Cancer Center Erlangen-EMN, Department of Gynecology and Obstetrics, Friedrich-Alexander University Erlangen-Nuremberg, Erlangen, Germany. Electronic address: peter.fasching@uk-erlangen.de.'}, {'ForeName': 'J Thaddeus', 'Initials': 'JT', 'LastName': 'Beck', 'Affiliation': 'Highlands Oncology Group, Fayetteville, AR, USA.'}, {'ForeName': 'Arlene', 'Initials': 'A', 'LastName': 'Chan', 'Affiliation': 'Breast Cancer Research Centre-Western Australia, Nedlands, WA, Australia.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'De Laurentiis', 'Affiliation': 'Istituto Nazionale Tumori IRCCS ""Fondazione G. Pascale"", Naples, Italy.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Esteva', 'Affiliation': 'NYU Langone Health, New York, NY, USA.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Jerusalem', 'Affiliation': 'CHU de Liège, University of Liège, Liège, Belgium.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Neven', 'Affiliation': 'Multidisciplinary Breast Centre, Universitair Ziekenhuis Leuven, Leuven, Belgium.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Pivot', 'Affiliation': 'Institut Régional Du Cancer, Strasbourg, France.'}, {'ForeName': 'Giulia V', 'Initials': 'GV', 'LastName': 'Bianchi', 'Affiliation': 'Fondazione IRCCS - Istituto Nazionale Dei Tumori, Milan, Italy.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Martin', 'Affiliation': 'Instituto de Investigación Sanitaria Gregorio Marañón, Ciberonc Geicam, Universidad Complutense de Madrid, Madrid, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Chandiwana', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Lanoue', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Ridolfi', 'Affiliation': 'Novartis Pharma SAS, Rueil-Malmaison, France.'}, {'ForeName': 'Yingbo', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Rodriguez Lorenc', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Arnd', 'Initials': 'A', 'LastName': 'Nusch', 'Affiliation': 'Practice for Haematology and Internal Oncology, Velbert, Germany.'}]","Breast (Edinburgh, Scotland)",['10.1016/j.breast.2020.09.008']
3424,33065358,Qualitative process evaluation of the Fostering Changes program for foster carers as part of the Confidence in Care randomized controlled trial.,"BACKGROUND


Fostering Changes is an in-service training program for foster carers designed to enhance carer skills, coping strategies and carer-child relationships. The training program has been evaluated in a randomised controlled trial comparing Fostering Changes to usual care.
OBJECTIVE


To conduct a qualitative process evaluation drawing on stakeholder perspectives to describe the logic model of Fostering Changes, identify potential mechanisms of impact of the program and enhance understanding of the trial results.
PARTICIPANTS AND SETTING


Participants were stakeholders in the Fostering Changes program delivered in Wales, UK including foster carers invited to attend the program (18 attendees, eight non-attendees), two program developers, five trainers, 12 social workers who attended or recruited to the program.
METHODS


Total population sampling with qualitative data collection methods. Qualitative data were subject to thematic analysis.
RESULTS


A logic model summarising the program resources, activities and anticipated outcomes was generated. Implementation themes were quality of training, setting and group composition. Mechanisms of impact were identified with themes falling into two categories, group process and skills development. Potential barriers to effectiveness included a poor fit between the carer needs and the program in relation to levels of challenge being faced, age-appropriate content and responsiveness. Contextual factors were also relevant, including the existing relationship between foster carers and the agency and the perceived value of training.
CONCLUSIONS


Although the group aspects of the program were well received, the program itself did not help foster carers deal with more complex challenges and needed to be more targeted in terms of carers needs and circumstances.",2020,"Although the group aspects of the program were well received, the program itself did not help foster carers deal with more complex challenges and needed to be more targeted in terms of carers needs and circumstances.","['Participants were stakeholders in the Fostering Changes program delivered in Wales, UK including foster carers invited to attend the program (18 attendees, eight non-attendees), two program developers, five trainers, 12 social workers who attended or recruited to the program', 'Total population sampling with qualitative data collection methods']",['Fostering Changes program'],[],"[{'cui': 'C0242298', 'cui_str': 'Fostering'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0043015', 'cui_str': 'Wales'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0453962', 'cui_str': 'Trainers'}, {'cui': 'C0037444', 'cui_str': 'Social worker'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0205556', 'cui_str': 'Qualitative'}, {'cui': 'C3887707', 'cui_str': 'Data Collection Methods'}]","[{'cui': 'C0242298', 'cui_str': 'Fostering'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",[],,0.0305087,"Although the group aspects of the program were well received, the program itself did not help foster carers deal with more complex challenges and needed to be more targeted in terms of carers needs and circumstances.","[{'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Channon', 'Affiliation': 'Centre for Trials Research, Cardiff University, Neuadd Meirionnydd, Heath Park, Cardiff, United Kingdom. Electronic address: ChannonS2@cardiff.ac.uk.'}, {'ForeName': 'Elinor', 'Initials': 'E', 'LastName': 'Coulman', 'Affiliation': 'Centre for Trials Research, Cardiff University, Neuadd Meirionnydd, Heath Park, Cardiff, United Kingdom. Electronic address: JohnE1@cardiff.ac.uk.'}, {'ForeName': 'Gwenllian', 'Initials': 'G', 'LastName': 'Moody', 'Affiliation': 'Centre for Trials Research, Cardiff University, Neuadd Meirionnydd, Heath Park, Cardiff, United Kingdom. Electronic address: MoodyG@cardiff.ac.uk.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Brookes-Howell', 'Affiliation': 'Centre for Trials Research, Cardiff University, Neuadd Meirionnydd, Heath Park, Cardiff, United Kingdom. Electronic address: Brookes-HowellLC@cardiff.ac.uk.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Cannings-John', 'Affiliation': 'Centre for Trials Research, Cardiff University, Neuadd Meirionnydd, Heath Park, Cardiff, United Kingdom. Electronic address: CanningsRL@cardiff.ac.uk.'}, {'ForeName': 'Mandy', 'Initials': 'M', 'LastName': 'Lau', 'Affiliation': 'Centre for Trials Research, Cardiff University, Neuadd Meirionnydd, Heath Park, Cardiff, United Kingdom. Electronic address: LauTM@cardiff.ac.uk.'}, {'ForeName': 'Alyson', 'Initials': 'A', 'LastName': 'Rees', 'Affiliation': ""Children's Social Care Research and Development Centre (CASCADE), School of Social Sciences, Cardiff University, United Kingdom. Electronic address: ReesA1@cardiff.ac.uk.""}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Segrott', 'Affiliation': 'Centre for Trials Research, Cardiff University, Neuadd Meirionnydd, Heath Park, Cardiff, United Kingdom; Centre for the Development and Evaluation of Complex Public Health Interventions for Public Health Improvement (DECIPHer), Cardiff University, United Kingdom. Electronic address: SegrottJ@cardiff.ac.uk.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Scourfield', 'Affiliation': ""Children's Social Care Research and Development Centre (CASCADE), School of Social Sciences, Cardiff University, United Kingdom; Centre for the Development and Evaluation of Complex Public Health Interventions for Public Health Improvement (DECIPHer), Cardiff University, United Kingdom. Electronic address: Scourfield@cardiff.ac.uk.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Robling', 'Affiliation': 'Centre for Trials Research, Cardiff University, Neuadd Meirionnydd, Heath Park, Cardiff, United Kingdom; Centre for the Development and Evaluation of Complex Public Health Interventions for Public Health Improvement (DECIPHer), Cardiff University, United Kingdom. Electronic address: RoblingMR@cardiff.ac.uk.'}]",Child abuse & neglect,['10.1016/j.chiabu.2020.104768']
3425,33065408,Biomarker-enhanced VTE risk stratification in ambulatory patients with cancer.,"INTRODUCTION


Risk assessment models are used to stratify cancer patients according to their underlying risk of VTE. The CATS score has been shown to enhance VTE risk stratification as compared to the modified Khorana score by incorporating d-dimer and soluble p-selectin measurements. Our aim was to evaluate the performance of the CATS score with respect to VTE risk stratification.
MATERIALS AND METHODS


Analysis of a subset of the AVERT trial population for whom biomarker data was available. All patients included in the AVERT trial were at increased risk of VTE based on a modified Khorana score of ≥2. Patients were stratified according to the modified Khorana score and CATS score. Kaplan-Meier analysis was used to calculate the 6-month cumulative probabilities of VTE.
RESULTS


A total of 466 patients were included in the analysis, 229 and 237 patients in the placebo and apixaban arms, respectively. The 6-month cumulative probability of VTE among patients with a modified Khorana score ≥ 3 was 13% [95% CI 7 to 23], whereas it was 20% [95% CI 11 to 35] for patients with a CATS score ≥ 4. The absolute risk reduction achieved with apixaban VTE prophylaxis among patients with modified Khorana ≥2, modified Khorana ≥3 and CATS ≥4 was -5.9% [-10.9 to -0.8], -5.8% [-16.0 to 4.5] and -10.1% [-22.9 to 2.6], respectively. Apixaban VTE prophylaxis among patients with increasing modified Khorana or CATS scores was not associated with an increased risk of bleeding events.
CONCLUSIONS


The use of a CATS score of ≥4 to identify ambulatory cancer patients at very high risk of VTE could enhance the benefit/risk ratio achieved with apixaban VTE prophylaxis.",2020,"Apixaban VTE prophylaxis among patients with increasing modified Khorana or CATS scores was not associated with an increased risk of bleeding events.
","['ambulatory patients with cancer', 'ambulatory cancer patients at very high risk of VTE', 'Analysis of a subset of the AVERT trial population for whom biomarker data was available', '466 patients were included in the analysis, 229 and 237 patients in the']",['placebo and apixaban'],"['risk of bleeding events', '6-month cumulative probability of VTE', 'modified Khorana or CATS scores', 'modified Khorana score and CATS score', 'risk of VTE']","[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0442804', 'cui_str': 'Very high'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0630906', 'cui_str': 'vinyltriethoxysilane'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1831808', 'cui_str': 'apixaban'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0630906', 'cui_str': 'vinyltriethoxysilane'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0007366', 'cui_str': 'Catalan language'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",466.0,0.0562162,"Apixaban VTE prophylaxis among patients with increasing modified Khorana or CATS scores was not associated with an increased risk of bleeding events.
","[{'ForeName': 'Joseph R', 'Initials': 'JR', 'LastName': 'Shaw', 'Affiliation': 'Department of Medicine, University of Ottawa, and the Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'Vaibhav', 'Initials': 'V', 'LastName': 'Kumar', 'Affiliation': 'Department of Medicine, University of North Carolina, Chapel Hill, NC, United States; University of North Carolina Blood Research Center.'}, {'ForeName': 'Ranjeeta', 'Initials': 'R', 'LastName': 'Mallick', 'Affiliation': 'Department of Medicine, University of Ottawa, and the Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Carrier', 'Affiliation': 'Department of Medicine, University of Ottawa, and the Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'Anton', 'Initials': 'A', 'LastName': 'Ilich', 'Affiliation': 'Department of Medicine, University of North Carolina, Chapel Hill, NC, United States; University of North Carolina Blood Research Center.'}, {'ForeName': 'Nigel S', 'Initials': 'NS', 'LastName': 'Key', 'Affiliation': 'Department of Medicine, University of North Carolina, Chapel Hill, NC, United States; University of North Carolina Blood Research Center.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Wells', 'Affiliation': 'Department of Medicine, University of Ottawa, and the Ottawa Hospital Research Institute, Ottawa, Canada. Electronic address: pwells@toh.ca.'}]",Thrombosis research,['10.1016/j.thromres.2020.09.035']
3426,33065448,"Effectiveness of a home-based early cognitive-motor intervention provided in daycare, home care, and foster care settings: Changes in motor development and context affordances.","BACKGROUND


Appropriate opportunities within the context are crucial to affect the motor trajectory positively.
OBJECTIVE


To investigate the effectiveness of professional-parental/caregivers' early motor-cognitive intervention on infants' motor development in Daycare (DC), Home Care (HC), and Foster Care (FC). Secondary objectives were to examine if parents and caregivers modified the context to meet the infants' needs and if making modifications was positively associated with infants' development.
METHODS


Participants were 176 infants (DC = 48; HC = 58, FC = 70). Infants' were randomly assigned to intervention (IG) or comparison (CG) groups within each context. The Alberta Infant Motor Scale and Affordances in the Daycare and Home Environment for Motor Development were used. A cognitive-motor intervention was provided for infants in the intervention groups; and, a home-based support protocol for all caregivers and parents.
RESULTS


IGs showed higher motor scores at post-test than CGs (p values from 0.018 to 0.026) and positive changes were observed from the pre-to-post intervention for all IGs (p ≤ .0001), and for two CGs (DC p ≤ .0001; HC p = .028). Maternal daily care and home opportunities improved for all infants.
CONCLUSIONS


Parents/caregivers' protocol combined with the cognitive-motor intervention lead to better motor outcomes and changes in the context for the IGs. Only the parent/caregivers' protocol was not strong to improve CGs motor outcomes, although changes in context were found. Intensive intervention is need for infants living in vulnerability.",2020,"RESULTS


IGs showed higher motor scores at post-test than CGs (p values from 0.018 to 0.026) and positive changes were observed from the pre-to-post intervention for all IGs (p ≤ .0001), and for two CGs (DC p ≤ .0001; HC p = .028).","['Infants', 'infants living in vulnerability', 'Participants were 176 infants (DC\xa0=\xa048; HC\xa0=\xa058, FC\xa0=\xa070']","['cognitive-motor intervention', 'intervention (IG) or comparison (CG', ""professional-parental/caregivers' early motor-cognitive intervention"", 'home-based early cognitive-motor intervention', 'Intensive intervention']","['Maternal daily care and home opportunities', ""infants' motor development in Daycare (DC), Home Care (HC), and Foster Care (FC"", 'CGs motor outcomes', 'motor scores']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}, {'cui': 'C0008070', 'cui_str': 'Child day care center'}, {'cui': 'C0204977', 'cui_str': 'Home care of patient'}, {'cui': 'C0419195', 'cui_str': 'Foster care'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0008070', 'cui_str': 'Child day care center'}, {'cui': 'C0204977', 'cui_str': 'Home care of patient'}, {'cui': 'C0419195', 'cui_str': 'Foster care'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",176.0,0.0591172,"RESULTS


IGs showed higher motor scores at post-test than CGs (p values from 0.018 to 0.026) and positive changes were observed from the pre-to-post intervention for all IGs (p ≤ .0001), and for two CGs (DC p ≤ .0001; HC p = .028).","[{'ForeName': 'Nadia Cristina', 'Initials': 'NC', 'LastName': 'Valentini', 'Affiliation': 'Universidade Federal do Rio Grande do Sul, UFRGS, Department of Physical Education, Physiotherapy and Dance, Porto Alegre, Rio Grande do Sul, Brazil. Electronic address: nadiacv@esef.ufrgs.br.'}, {'ForeName': 'Carla Skilhan', 'Initials': 'CS', 'LastName': 'de Almeida', 'Affiliation': 'Universidade Federal do Rio Grande do Sul, UFRGS, Department of Physical Education, Physiotherapy and Dance, Porto Alegre, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Beth A', 'Initials': 'BA', 'LastName': 'Smith', 'Affiliation': 'University of Southern California, Division of Biokinesiology and Physical Therapy, Los Angeles, CA, USA.'}]",Early human development,['10.1016/j.earlhumdev.2020.105223']
3427,33065472,Individual variation in alpha neurofeedback training efficacy predicts pain modulation.,"Studies have shown an association between sensorimotor α-oscillation and pain perception. It suggests the potential use of neurofeedback (NFB) training for pain modulation through modifying sensorimotor α-oscillation. Here, a single-session NFB training protocol targeted on increasing sensorimotor α-oscillations was applied to forty-five healthy participants. Pain thresholds to nociceptive laser stimulations and pain ratings (intensity and unpleasantness) to identical laser painful stimulations were assessed immediately before and after NFB training. Participants had larger pain thresholds, but rated the identical painful laser stimulation as more unpleasant after NFB training. These pain measurements were further compared between participants with high or low NFB training efficacy that was quantified as the regression slope of α-oscillation throughout the ten training blocks. A significant increase in pain thresholds was observed among participants with high-efficacy; whereas a significant increase in pain ratings was observed among participants with low-efficacy. These results suggested that NFB training decreased the sensory-discriminative aspect of pain, but increased the affective-motivational aspect of pain, whereas both pain modulations were dependent upon the NFB training efficacy. Importantly, correlation analysis across all participants revealed that a greater NFB training efficacy predicted a greater increase in pain thresholds particularly at hand contralateral to NFB target site, but no significant correlation was observed between NFB training efficacy and modulation on pain ratings. It thus provided causal evidence for a link between sensorimotor α-oscillation and the sensory-discriminative aspect of pain, and highlighted the need for personalized neurofeedback for the benefits on pain modulation at the individual level. Future studies can adopt a double-blind sham-controlled protocol to validate NFB training induced pain modulation.",2020,Pain thresholds to nociceptive laser stimulations and pain ratings (intensity and unpleasantness) to identical laser painful stimulations were assessed immediately before and after NFB training.,['forty-five healthy participants'],"['neurofeedback (NFB) training', 'NFB training']","['pain ratings', 'affective-motivational aspect of pain', 'NFB training efficacy', 'larger pain thresholds', 'NFB training efficacy and modulation on pain ratings', 'pain thresholds', 'pain modulations', 'pain measurements', 'pain modulation', 'pain ratings (intensity and unpleasantness', 'sensory-discriminative aspect of pain']","[{'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C2713543', 'cui_str': 'Electroencephalographic biofeedback'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2713543', 'cui_str': 'Electroencephalographic biofeedback'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0030198', 'cui_str': 'Pain assessment'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}]",45.0,0.0367678,Pain thresholds to nociceptive laser stimulations and pain ratings (intensity and unpleasantness) to identical laser painful stimulations were assessed immediately before and after NFB training.,"[{'ForeName': 'Weiwei', 'Initials': 'W', 'LastName': 'Peng', 'Affiliation': 'School of Psychology, Shenzhen University, Shenzhen, Guangdong, China; Shenzhen Key Laboratory of Affective and Social Cognitive Science, Shenzhen University, Shenzhen, Guangdong, China.'}, {'ForeName': 'Yilin', 'Initials': 'Y', 'LastName': 'Zhan', 'Affiliation': 'School of Psychology, Shenzhen University, Shenzhen, Guangdong, China.'}, {'ForeName': 'Yali', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Department of Psychology, Shanghai Normal University, Shanghai, China.'}, {'ForeName': 'Wenya', 'Initials': 'W', 'LastName': 'Nan', 'Affiliation': 'Department of Psychology, Shanghai Normal University, Shanghai, China. Electronic address: wynan1985@126.com.'}, {'ForeName': 'Roi Cohen', 'Initials': 'RC', 'LastName': 'Kadosh', 'Affiliation': 'Wellcome Centre for Integrative Neuroimaging, Department of Experimental Psychology, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Wan', 'Affiliation': 'Department of Electrical and Computer Engineering, Faculty of Science and Technology, University of Macau, Macau, China; Centre for Cognitive and Brain Sciences, Institute of Collaborative Innovation, University of Macau, Macau, China.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2020.102454']
3428,33052906,Association between behavioral phenotypes and response to a physical activity intervention using gamification and social incentives: Secondary analysis of the STEP UP randomized clinical trial.,"Participants often vary in their response to behavioral interventions, but methods to identify groups of participants that are more likely to respond are lacking. In this secondary analysis of a randomized clinical trial, we used baseline characteristics to group participants into distinct behavioral phenotypes and evaluated differential responses to a physical activity intervention. Latent class analysis was used to segment participants based on baseline participant data including demographics, validated measures of psychosocial variables, and physical activity behavior. The trial included 602 adults from 40 U.S. states with body mass index ≥25 who were randomized to control or one of three gamification interventions (supportive, collaborative, or competitive) to increase physical activity. Daily step counts were monitored using a wearable device for a 24-week intervention with 12 weeks of follow-up. The model segmented participants into three classes named for key defining traits: Class 1, extroverted and motivated; Class 2, less active and less social; Class 3, less motivated and at-risk. Adjusted regression models were used to test for differences in intervention response relative to control within each behavioral phenotype. In Class 1, only participants in the competitive arm increased their mean daily steps during the intervention (adjusted difference, 945; 95% CI, 352-1537; P = .002), but it was not sustained during follow-up. In Class 2, participants in all three gamification arms significantly increased their mean daily steps compared to control during the intervention (supportive arm adjusted difference 1172; 95% CI, 363-1980; P = .005; collaborative arm adjusted difference 1119; 95% CI, 319-1919; P = .006; competitive arm adjusted difference 1179; 95% CI, 400-1957; P = .003) and all three had sustained impact during follow-up. In Class 3, none of the interventions had a significant effect on physical activity. Three behavioral phenotypes were identified, each with a different response to the interventions. This approach could be used to better target behavioral interventions to participants that are more likely to respond to them.",2020,"In Class 2, participants in all three gamification arms significantly increased their mean daily steps compared to control during the intervention (supportive arm adjusted difference 1172; 95% CI, 363-1980; P = .005; collaborative arm adjusted difference 1119; 95% CI, 319-1919; P = .006; competitive arm adjusted difference 1179; 95% CI, 400-1957; P = .003) and all three had sustained impact during follow-up.","['group participants into distinct behavioral phenotypes and evaluated differential responses to a physical activity intervention', 'model segmented participants into three classes named for key defining traits: Class 1, extroverted and motivated; Class 2, less active and less social; Class 3, less motivated and at-risk', '602 adults from 40 U.S. states with body mass index ≥25 who were randomized to control or one of three']","['physical activity intervention', 'gamification interventions (supportive, collaborative, or competitive']","['mean daily steps', 'physical activity']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1321146', 'cui_str': 'Behavioral phenotype'}, {'cui': 'C0443199', 'cui_str': 'Differential'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0027365', 'cui_str': 'Name'}, {'cui': 'C0441885', 'cui_str': 'Class 1'}, {'cui': 'C0441886', 'cui_str': 'Class 2'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0441887', 'cui_str': 'Class 3'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",602.0,0.0609845,"In Class 2, participants in all three gamification arms significantly increased their mean daily steps compared to control during the intervention (supportive arm adjusted difference 1172; 95% CI, 363-1980; P = .005; collaborative arm adjusted difference 1119; 95% CI, 319-1919; P = .006; competitive arm adjusted difference 1179; 95% CI, 400-1957; P = .003) and all three had sustained impact during follow-up.","[{'ForeName': 'Xisui Shirley', 'Initials': 'XS', 'LastName': 'Chen', 'Affiliation': 'Department of Medicine, University of Pennyslvania Perelman School of Medicine, Philadelphia, Pennsylvania, United States of America.'}, {'ForeName': 'Sujatha', 'Initials': 'S', 'LastName': 'Changolkar', 'Affiliation': 'Penn Medicine Nudge Unit, University of Pennyslvania, Philadelphia, Pennsylvania, United States of America.'}, {'ForeName': 'Amol S', 'Initials': 'AS', 'LastName': 'Navathe', 'Affiliation': 'Department of Medicine, University of Pennyslvania Perelman School of Medicine, Philadelphia, Pennsylvania, United States of America.'}, {'ForeName': 'Kristin A', 'Initials': 'KA', 'LastName': 'Linn', 'Affiliation': 'Department of Biostatistics, Epidemiology and Informatics, University of Pennyslvania Perelman School of Medicine, Philadelphia, Pennsylvania, United States of America.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Reh', 'Affiliation': 'Deloitte Consulting, Philadelphia, Pennsylvania, United States of America.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Szwartz', 'Affiliation': 'Deloitte Consulting, Philadelphia, Pennsylvania, United States of America.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Steier', 'Affiliation': 'Deloitte Consulting, Philadelphia, Pennsylvania, United States of America.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Godby', 'Affiliation': 'Deloitte Consulting, Philadelphia, Pennsylvania, United States of America.'}, {'ForeName': 'Mohan', 'Initials': 'M', 'LastName': 'Balachandran', 'Affiliation': 'Penn Medicine Nudge Unit, University of Pennyslvania, Philadelphia, Pennsylvania, United States of America.'}, {'ForeName': 'Joseph D', 'Initials': 'JD', 'LastName': 'Harrison', 'Affiliation': 'Penn Medicine Nudge Unit, University of Pennyslvania, Philadelphia, Pennsylvania, United States of America.'}, {'ForeName': 'Charles A L', 'Initials': 'CAL', 'LastName': 'Rareshide', 'Affiliation': 'Penn Medicine Nudge Unit, University of Pennyslvania, Philadelphia, Pennsylvania, United States of America.'}, {'ForeName': 'Mitesh S', 'Initials': 'MS', 'LastName': 'Patel', 'Affiliation': 'Department of Medicine, University of Pennyslvania Perelman School of Medicine, Philadelphia, Pennsylvania, United States of America.'}]",PloS one,['10.1371/journal.pone.0239288']
3429,33052922,Emotional flexibility and general self-efficacy: A pilot training intervention study with knowledge workers.,"Emotional flexibility advancement has been found to be highly effective in clinical settings to treat, for example, depression, anxiety, and chronic pain. Developing these skills in the working context has also shown very encouraging results in public sector settings. Also, a few studies have revealed effectiveness in a private sector setting, but no studies have yet looked at the effectiveness of developing these skills amongst high-paced, high-demanding, and highly-educated knowledge workers. In this pilot training intervention study, we report evidence that emotional flexibility can be developed in this context. We conducted an experiment with treatment and control groups, with only the treatment group receiving an emotional flexibility training. Emotional flexibility improved significantly for the treatment group, whereas the improvements were minimal or negative for the control group. Furthermore, we reveal that General self-efficacy improved amongst treatment group participants (and not for control group participants), and that this is associated with emotional flexibility. Finally, we show that the improvements were higher for participants starting from a lower baseline.",2020,"Emotional flexibility improved significantly for the treatment group, whereas the improvements were minimal or negative for the control group.",['knowledge workers'],['emotional flexibility training'],"['Emotional flexibility', 'General self-efficacy', 'Emotional flexibility and general self-efficacy']","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1306056', 'cui_str': 'Worker'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",,0.0276821,"Emotional flexibility improved significantly for the treatment group, whereas the improvements were minimal or negative for the control group.","[{'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Brassey', 'Affiliation': 'Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Arjen van', 'Initials': 'AV', 'LastName': 'Witteloostuijn', 'Affiliation': 'Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Csaba', 'Initials': 'C', 'LastName': 'Huszka', 'Affiliation': 'Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Silberzahn', 'Affiliation': 'McKinsey & Company, Berlin, Germany.'}, {'ForeName': 'Nick van', 'Initials': 'NV', 'LastName': 'Dam', 'Affiliation': 'IE University, Segovia, Spain.'}]",PloS one,['10.1371/journal.pone.0237821']
3430,33053456,Symptoms of gluten ingestion in patients with non-celiac gluten sensitivity: A randomized clinical trial.,"OBJECTIVES


Non-celiac gluten sensitivity (NCGS) is the presence of symptoms induced by gluten and relieved by a gluten-free diet (GFD) in patients without celiac disease or wheat allergy. Studies are mixed as to whether gluten is the main symptom trigger in patients with NCGS. Gluten immunogenic peptides (GIPs) in stool and urine are novel methods to monitor GFD compliance. Few studies have investigated their use in patients with NCGS. The aim of this study was to assess whether patients with NCGS have increased symptoms with gluten ingestion and to assess compliance with the GFD using stool and urine GIPs.
METHOD


This was a prospective, randomized, double-blinded crossover trial evaluating symptoms in patients with NCGS. Thirty patients with NCGS and 43 healthy controls were placed on a GFD. Patients received 0.5 or 2 g/d of gluten for 7 d each. The remaining weeks, they received placebo for a total of 4 wk. Symptoms were evaluated weekly using the Celiac Symptom Index (CSI). Urine and stool samples were collected weekly and measured for the detection of GIPs to detect exposure to gluten.
RESULTS


There was no difference in symptom severity within the NCGS group whether receiving placebo or gluten (32.69 versus 31.54, P = 0.64). Patients with NCGS had significantly higher CSI scores at baseline than healthy controls. Patients with NCGS were less likely to have stool and urine GIPs than healthy patients.
CONCLUSION


Patients with NCGS were more adherent to the GFD based on stool and urine GIP results. Patients with NCGS had increased symptom severity at baseline compared with healthy controls. Neither group had significantly increased symptoms after ingestion of gluten.",2020,"There was no difference in symptom severity within the NCGS group whether receiving placebo or gluten (32.69 versus 31.54, P = 0.64).","['Thirty patients with NCGS and 43 healthy controls', 'Patients with NCGS', 'patients with NCGS', 'patients without celiac disease or wheat allergy', 'patients with non-celiac gluten sensitivity']","['Gluten immunogenic peptides (GIPs', 'NCGS', 'placebo']","['Urine and stool samples', 'stool and urine GIPs', 'CSI scores', 'symptom severity', 'symptoms after ingestion of gluten', 'Celiac Symptom Index (CSI']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2711053', 'cui_str': 'Non-celiac gluten sensitivity'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0007570', 'cui_str': 'Celiac disease'}, {'cui': 'C0949570', 'cui_str': 'Allergy to wheat'}]","[{'cui': 'C2362561', 'cui_str': 'Gluten'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}, {'cui': 'C2711053', 'cui_str': 'Non-celiac gluten sensitivity'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C1550661', 'cui_str': 'Stool specimen'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C2362561', 'cui_str': 'Gluten'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}, {'cui': 'C0007570', 'cui_str': 'Celiac disease'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}]",30.0,0.18729,"There was no difference in symptom severity within the NCGS group whether receiving placebo or gluten (32.69 versus 31.54, P = 0.64).","[{'ForeName': 'Stephanie M', 'Initials': 'SM', 'LastName': 'Moleski', 'Affiliation': 'Department of Medicine, Division of Gastroenterology and Hepatology, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States. Electronic address: Stephanie.moleski@jefferson.edu.'}, {'ForeName': 'Apeksha', 'Initials': 'A', 'LastName': 'Shah', 'Affiliation': 'Department of Medicine, Division of Gastroenterology and Hepatology, Cooper University Hospital, Camden, New Jersey, United States.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Durney', 'Affiliation': 'Department of Medicine, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Matthews', 'Affiliation': 'Department of Medicine, Division of Gastroenterology and Hepatology, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States.'}, {'ForeName': 'Gagan', 'Initials': 'G', 'LastName': 'Kaushal', 'Affiliation': 'Jefferson College of Pharmacy, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Smith', 'Affiliation': 'Department of Medicine, Division of Gastroenterology and Hepatology, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States.'}, {'ForeName': 'Katelyn C', 'Initials': 'KC', 'LastName': 'Koons', 'Affiliation': 'Sidney Kimmel Medical College, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Rubin', 'Affiliation': 'Department of Medicine, Division of Gastroenterology and Hepatology, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Casey', 'Affiliation': 'Department of Medicine, Division of Gastroenterology and Hepatology, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Miller', 'Affiliation': 'Department of Medicine, Division of Gastroenterology and Hepatology, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Miller', 'Affiliation': 'Department of Medicine, Division of Gastroenterology and Hepatology, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States.'}, {'ForeName': 'Mahreema', 'Initials': 'M', 'LastName': 'Jawairia', 'Affiliation': 'Lehigh Gastroenterology Associates, Palmerton, Pennsylvania, United States.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Hasan', 'Affiliation': 'Lehigh Gastroenterology Associates, Palmerton, Pennsylvania, United States.'}, {'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'DiMarino', 'Affiliation': 'Department of Medicine, Division of Gastroenterology and Hepatology, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2020.110944']
3431,33061673,Magnesium Sulfate Improves Some Risk Factors for Atherosclerosis in Patients Suffering from One or Two Coronary Artery Diseases: A Double-blind Clinical Trial Study.,"Purpose


Given the beneficial effect of MgSO 4  on the cardiovascular system, this study was designed to investigate the effect of MgSO 4  administration on suppressing some atherosclerotic risk factors in moderate coronary artery disease patients with one or two atherosclerotic vessels.
Patients and Methods


In a randomized double-blind placebo-controlled clinical trial study, 64 patients with moderate coronary artery disease (55-69% stenosis) were selected according to angiography findings. Patients were divided into four groups including patients with one or two atherosclerotic vessels treated with MgSO 4  (Mg-treated-VR1, Mg-treated-VR2, respectively), placebo treated patients with one or two atherosclerotic vessels (Control-VR1, Control-VR2, respectively). The patients received either placebo or MgSO 4  supplement capsule containing 300 mg MgSO 4  for six months on a daily basis. ESR, Ca/Mg ratio, urine Mg level, serum Mg, fibrinogen, homocysteine, uric acid, Na, K, Ca, CRP, T3, T4, TSH, BUN, and Cr concentrations were measured at baseline and every three months.
Results


Serum T3, Ca, K, homocysteine, CRP, and Mg concentrations were significantly improved in Mg-treated groups compared to placebo groups.
Conclusion


The results of this study showed that despite the slight change in serum magnesium level, oral administration of MgSO 4 for six months could slightly reduce the serum levels of some inflammatory and vascular factors in moderate coronary artery disease patients.",2020,"Serum T3, Ca, K, homocysteine, CRP, and Mg concentrations were significantly improved in Mg-treated groups compared to placebo groups.
","['moderate coronary artery disease patients with one or two atherosclerotic vessels', '64 patients with moderate coronary artery disease (55-69% stenosis', 'moderate coronary artery disease patients', 'Patients Suffering from One or Two Coronary Artery Diseases']","['Magnesium Sulfate', 'placebo', 'placebo or MgSO', 'atherosclerotic vessels treated with MgSO 4  (Mg-treated-VR1, Mg-treated-VR2, respectively), placebo treated patients with one or two atherosclerotic vessels (Control-VR1, Control-VR2, respectively']","['atherosclerotic risk factors', 'serum magnesium level', 'Serum T3, Ca, K, homocysteine, CRP, and Mg concentrations', 'ESR, Ca/Mg ratio, urine Mg level, serum Mg, fibrinogen, homocysteine, uric acid, Na, K, Ca, CRP, T3, T4, TSH, BUN, and Cr concentrations']","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}]","[{'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0202125', 'cui_str': 'Magnesium measurement, serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0019878', 'cui_str': 'Homocysteine'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0013845', 'cui_str': 'Electron spin resonance measurement'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0016006', 'cui_str': 'Fibrinogen'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0040160', 'cui_str': 'Thyrotropin'}, {'cui': 'C0005845', 'cui_str': 'Blood urea nitrogen measurement'}]",64.0,0.238328,"Serum T3, Ca, K, homocysteine, CRP, and Mg concentrations were significantly improved in Mg-treated groups compared to placebo groups.
","[{'ForeName': 'Ali Reza', 'Initials': 'AR', 'LastName': 'Sobhani', 'Affiliation': 'Clinical Pathology Department, Faculty of Medicine, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Farshidi', 'Affiliation': 'Cardiovascular Research Center, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Fariba', 'Initials': 'F', 'LastName': 'Azarkish', 'Affiliation': 'Molecular Medicine Research Center, Hormozgan Health Institute, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Mahdiya', 'Initials': 'M', 'LastName': 'Eslami', 'Affiliation': 'Cardiovascular Research Center, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Ebrahim', 'Initials': 'E', 'LastName': 'Eftekhar', 'Affiliation': 'Endocrinology and Metabolism Research Center, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Mansoor', 'Initials': 'M', 'LastName': 'Keshavarz', 'Affiliation': 'Physiology Department, Faculty of Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Nepton', 'Initials': 'N', 'LastName': 'Soltani', 'Affiliation': 'Physiology Department, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.'}]",Clinical pharmacology : advances and applications,['10.2147/CPAA.S261264']
3432,33061677,Clinical Outcomes of a Modified Laryngeal Mask Airway (LMA ®  Gastro™ Airway) During Esophagogastroduodenoscopy in Children and Adolescents: A Randomized Study.,"Introduction


During esophagogastroduodenoscopy (EGD), general anesthesia (GA) may be provided using a laryngeal mask airway (LMA) with the endoscope inserted behind the cuff of the LMA into the esophagus. Passage of the endoscope may increase the intracuff of the LMA. We evaluated a newly designed LMA (LMA ®  Gastro™ Airway) which has an internal channel exiting from its distal end to facilitate EGD. The current study compared the change of LMA cuff pressure between this new LMA and a standard clinical LMA (Ambu ®  AuraOnce™) during EGD.
Methods


Patients less than 21 years of age and weighing more than 30 kg were randomized to receive airway management with one of the two LMAs during EGD. After anesthetic induction and successful LMA placement, the intracuff pressure of the LMAs was continuously monitored during the procedure. The primary outcome was the change of intracuff pressure of the LMAs.
Results


The study cohort included 200 patients (mean age 13.6 years and weight 56.6 kg) who were randomized to the LMA ®  Gastro™ Airway (n=100) or the Ambu ®  AuraOnce™ LMA (n=100). Average intracuff pressures during the study period (before and after endoscope insertion) were not different between the two LMAs. Ease of the procedure was slightly improved with the LMA ®  Gastro™ Airway (p<0.001).
Discussion


The LMA ®  Gastro™ Airway blunted, but did not prevent an increase in intracuff pressure during EGD when compared to the Ambu ®  AuraOnce™ LMA. Throat soreness was generally low, and complications were infrequent in both groups. The ease of the procedure was slightly improved with the LMA ®  Gastro™ Airway compared to the Ambu ®  AuraOnce™ LMA.",2020,The ease of the procedure was slightly improved with the LMA ®  Gastro™ Airway compared to the Ambu ®  AuraOnce™ LMA.,"['200 patients (mean age 13.6 years and weight 56.6 kg) who were randomized to the LMA ®  Gastro™ Airway (n=100) or the Ambu ®  AuraOnce™ LMA (n=100', 'Children and Adolescents', 'Methods\n\n\nPatients less than 21 years of age and weighing more than 30 kg']","['esophagogastroduodenoscopy (EGD), general anesthesia (GA', 'Modified Laryngeal Mask Airway (LMA ®  Gastro™ Airway', 'Esophagogastroduodenoscopy']","['Throat soreness', 'intracuff pressure of the LMAs', 'intracuff pressure', 'change of intracuff pressure of the LMAs', 'LMA cuff pressure', 'Average intracuff pressures']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517560', 'cui_str': '13.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0162645', 'cui_str': 'Laryngeal mask'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient'}, {'cui': 'C0439093', 'cui_str': '>'}]","[{'cui': 'C0079304', 'cui_str': 'Esophagogastroduodenoscopy'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0162645', 'cui_str': 'Laryngeal mask'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}]","[{'cui': 'C0031350', 'cui_str': 'Pharyngitis'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162645', 'cui_str': 'Laryngeal mask'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0441107', 'cui_str': 'Device cuff'}]",200.0,0.0542715,The ease of the procedure was slightly improved with the LMA ®  Gastro™ Airway compared to the Ambu ®  AuraOnce™ LMA.,"[{'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Hakim', 'Affiliation': ""Department of Anesthesiology & Pain Medicine, Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Bryant', 'Affiliation': ""Department of Anesthesiology & Pain Medicine, Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Miketic', 'Affiliation': ""Department of Anesthesiology & Pain Medicine, Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Kent', 'Initials': 'K', 'LastName': 'Williams', 'Affiliation': ""Division of Pediatric Gastroenterology, Hepatology and Nutrition, Department of Pediatrics, Nationwide Children's Hospital and the Ohio State University, Columbus, OH, USA.""}, {'ForeName': 'Steven H', 'Initials': 'SH', 'LastName': 'Erdman', 'Affiliation': ""Division of Pediatric Gastroenterology, Hepatology and Nutrition, Department of Pediatrics, Nationwide Children's Hospital and the Ohio State University, Columbus, OH, USA.""}, {'ForeName': 'Shabana Z', 'Initials': 'SZ', 'LastName': 'Shafy', 'Affiliation': ""Department of Anesthesiology & Pain Medicine, Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Stephani S', 'Initials': 'SS', 'LastName': 'Kim', 'Affiliation': ""Department of Anesthesiology & Pain Medicine, Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Joseph D', 'Initials': 'JD', 'LastName': 'Tobias', 'Affiliation': ""Department of Anesthesiology & Pain Medicine, Nationwide Children's Hospital, Columbus, OH, USA.""}]","Medical devices (Auckland, N.Z.)",['10.2147/MDER.S272557']
3433,33061724,"Effects of Lactoferrin on Sleep Conditions in Children Aged 12-32 Months: A Preliminary, Randomized, Double-Blind, Placebo-Controlled Trial.","Purpose


To investigate preliminarily the effect of lactoferrin (LF)-fortified formula on sleep conditions in children.
Study Design


A preliminary, randomized, double-blind, placebo-controlled trial.
Methods


Healthy children between the ages of 12 and 32 months who attended nursery schools in Japan were divided into two groups and assigned a placebo or LF (48 mg/day)-fortified formula. Children's sleep conditions were investigated before and after the 13-week intervention using the Japanese Sleep Questionnaire for Preschoolers (JSQ-P).
Results


Altogether, 109 participants were randomized. Eight participants were eliminated due to lost to follow-up, withdrawal of consent, and ineligibility, with 101 participants (placebo, n = 48; LF, n = 53) included in the full analysis set (FAS) and used for analysis. Wake-up time, bedtime, and nighttime sleep were comparable between the two groups before and after intervention. The change in total JSQ-P T scores tended to improve in the LF group (placebo vs LF: 0.5 ± 6.5 vs -1.9 ± 6.1, p = 0.074), in particular, morning symptoms significantly improved (grumpy in the morning, hard to wake-up, and hard to get out of bed) (placebo vs LF: 0.8 ± 6.2 vs -1.9 ± 6.2, p = 0.028). A better trend was also observed in the LF group regarding restless legs syndrome (RLS)-motor (rubs feet at night and touches feet at night) (placebo vs LF: 2.3 ± 10.7 vs -0.6 ± 13.5, p = 0.083) and insufficient sleep (stays up more than one hour later the day before a holiday and wakes up more than one hour later on a holiday) (placebo vs LF: 0.1 ± 9.8 vs -1.7 ± 8.8, p = 0.095). No adverse drug reactions were found.
Conclusion


LF intake may improve sleep condition, especially morning symptoms in children above one year of age.",2020,"The change in total JSQ-P T scores tended to improve in the LF group (placebo vs LF: 0.5 ± 6.5 vs -1.9 ± 6.1, p = 0.074), in particular, morning symptoms significantly improved (grumpy in the morning, hard to wake-up, and hard to get out of bed)","['children above one year of age', 'Healthy children between the ages of 12 and 32 months who attended nursery schools in Japan', 'Eight participants were eliminated due to lost to follow-up, withdrawal of consent, and ineligibility, with 101 participants (placebo, n = 48; LF, n = 53) included in the full analysis set (FAS) and used for analysis', 'Children Aged 12-32 Months', '109 participants were randomized', 'children']","['placebo', 'lactoferrin (LF)-fortified formula', 'Lactoferrin', 'placebo or LF', 'Placebo']","['adverse drug reactions', 'insufficient sleep (stays', 'sleep condition', 'Wake-up time, bedtime, and nighttime sleep', 'Sleep Conditions', 'total JSQ-P T scores', ""Children's sleep conditions""]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0578819', 'cui_str': 'Attending nursery school'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C1302313', 'cui_str': 'Lost to follow-up'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0022942', 'cui_str': 'Lactoferrin'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0022942', 'cui_str': 'Lactoferrin'}]","[{'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0521112', 'cui_str': 'Bedtime'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C0008059', 'cui_str': 'Child'}]",109.0,0.585726,"The change in total JSQ-P T scores tended to improve in the LF group (placebo vs LF: 0.5 ± 6.5 vs -1.9 ± 6.1, p = 0.074), in particular, morning symptoms significantly improved (grumpy in the morning, hard to wake-up, and hard to get out of bed)","[{'ForeName': 'Momoko', 'Initials': 'M', 'LastName': 'Miyakawa', 'Affiliation': 'Food Ingredients and Technology Institute, R&D Division, Morinaga Milk Industry Co., Ltd, Zama, Kanagawa, Japan.'}, {'ForeName': 'Shutaro', 'Initials': 'S', 'LastName': 'Kubo', 'Affiliation': 'Food Ingredients and Technology Institute, R&D Division, Morinaga Milk Industry Co., Ltd, Zama, Kanagawa, Japan.'}, {'ForeName': 'Hirotsugu', 'Initials': 'H', 'LastName': 'Oda', 'Affiliation': 'Food Ingredients and Technology Institute, R&D Division, Morinaga Milk Industry Co., Ltd, Zama, Kanagawa, Japan.'}, {'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Motoki', 'Affiliation': 'Department of Preventive Medicine and Public Health, Shinshu University School of Medicine, Matsumoto, Nagano, Japan.'}, {'ForeName': 'Masaru', 'Initials': 'M', 'LastName': 'Mizuki', 'Affiliation': 'Department of Preventive Medicine and Public Health, Shinshu University School of Medicine, Matsumoto, Nagano, Japan.'}, {'ForeName': 'Teruomi', 'Initials': 'T', 'LastName': 'Tsukahara', 'Affiliation': 'Department of Preventive Medicine and Public Health, Shinshu University School of Medicine, Matsumoto, Nagano, Japan.'}, {'ForeName': 'Miyuki', 'Initials': 'M', 'LastName': 'Tanaka', 'Affiliation': 'Food Ingredients and Technology Institute, R&D Division, Morinaga Milk Industry Co., Ltd, Zama, Kanagawa, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Yamauchi', 'Affiliation': 'Food Ingredients and Technology Institute, R&D Division, Morinaga Milk Industry Co., Ltd, Zama, Kanagawa, Japan.'}, {'ForeName': 'Fumiaki', 'Initials': 'F', 'LastName': 'Abe', 'Affiliation': 'Food Ingredients and Technology Institute, R&D Division, Morinaga Milk Industry Co., Ltd, Zama, Kanagawa, Japan.'}, {'ForeName': 'Tetsuo', 'Initials': 'T', 'LastName': 'Nomiyama', 'Affiliation': 'Department of Preventive Medicine and Public Health, Shinshu University School of Medicine, Matsumoto, Nagano, Japan.'}]",Nature and science of sleep,['10.2147/NSS.S263106']
3434,33061725,Deciphering Age Differences in Experience-Based Decision-Making: The Role of Sleep.,"Objective


Recent studies have demonstrated that sleep not only facilitates memory consolidation but also benefits more complex cognitive skills such as decision-making in young adults. Older adults use different decision strategies compared with young adults, which leaves the role of sleep in older adults' decision-making unclear. We investigated the age-by-sleep effect on decision-making.
Methods


We recruited 67 young adults (ages 18 to 29 years) and 66 older adults (ages 60 to 79 years) and randomly assigned them into the ""sleep"" or ""wake"" study condition. They were given a modified Iowa gambling task to perform before and after a 12-hour interval with sleep or wakefulness.
Results


Using the typical model-free analysis, we found that young adults' between-session performance improved greater than that of older adults regardless of the sleep/wake condition. Furthermore, older adults with longer total sleep time showed a greater improvement in the selection of one ""good"" deck. To further examine the sleep effect on age-related differences in cognitive processes underlying decision-making, we conducted computational modelling. This more fine-grained analysis revealed that sleep improved feedback sensitivity for both young and older adults while it increased loss aversion for older adults but not for young adults.
Conclusion


These findings indicate that sleep promotes learning-based decision-making performance via facilitating value representation, and such modulation is distinct in young compared to older adults.",2020,"Furthermore, older adults with longer total sleep time showed a greater improvement in the selection of one ""good"" deck.","['Older adults', '67 young adults (ages 18 to 29 years) and 66 older adults (ages 60 to 79 years', 'young adults', 'older adults with longer']","['sleep"" or ""wake"" study condition']","['loss aversion', 'feedback sensitivity', 'total sleep time']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205166', 'cui_str': 'Long'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0233496', 'cui_str': 'Aversion'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",67.0,0.0221485,"Furthermore, older adults with longer total sleep time showed a greater improvement in the selection of one ""good"" deck.","[{'ForeName': 'Xue-Rui', 'Initials': 'XR', 'LastName': 'Peng', 'Affiliation': ""Faculty of Psychology, Southwest University, Chongqing, People's Republic of China.""}, {'ForeName': 'Yun-Rui', 'Initials': 'YR', 'LastName': 'Liu', 'Affiliation': ""Faculty of Psychology, Southwest University, Chongqing, People's Republic of China.""}, {'ForeName': 'Dong-Qiong', 'Initials': 'DQ', 'LastName': 'Fan', 'Affiliation': ""Faculty of Psychology, Southwest University, Chongqing, People's Republic of China.""}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Lei', 'Affiliation': ""Faculty of Psychology, Southwest University, Chongqing, People's Republic of China.""}, {'ForeName': 'Quan-Ying', 'Initials': 'QY', 'LastName': 'Liu', 'Affiliation': ""Department of Biomedical Engineering, Southern University of Science and Technology, Shenzhen, People's Republic of China.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': ""Faculty of Psychology, Southwest University, Chongqing, People's Republic of China.""}]",Nature and science of sleep,['10.2147/NSS.S272176']
3435,33062236,Rationale and design of the expanded combination of evolocumab plus empagliflozin in diabetes: EXCEED-BHS3 trial.,"Background


Patients with type 2 diabetes mellitus (T2DM) remain at increased cardiovascular residual risk and endothelial dysfunction, even after optimizing metabolic control and treatment by sodium-glucose-2 transporter inhibitors (SGLT2-is). The present study was based on the hypothesis that proprotein convertase subtilisin/kexin 9 inhibitor (PCSK9i) therapy may mitigate endothelial dysfunction in T2DM patients who are on regular treatment by SGLT2-i.
Methods


The EXCEED-BHS3 is a prospective, single-center, investigator-blinded, open-label, randomized clinical trial. Participants ( n  = 110) will be randomized (1:1) to either empagliflozin 25 mg/day alone or empagliflozin 25 mg/day plus evolocumab 140 mg every 2 weeks in addition to optimal medical care. The primary endpoint was defined as the change in the 1-min flow-mediated dilation (FMD) after 16 weeks of treatment. The secondary endpoint is the FMD change after ischemia/reperfusion injury protocol (reserve FMD) after 16 weeks of treatment. Exploratory outcomes comprise the change in FMD and reserve FMD after 8 weeks of treatment and the change after 16 weeks of treatment in the following parameters: plasma levels of nitric oxide, vascular cell adhesion molecule-1 and isoprostane, high-density lipoprotein (HDL) and low-density lipoprotein subfractions profile, HDL function, blood pressure, body mass index, waist circumference and adipokines.
Conclusion


This will be the first study to evaluate the add-on effect of PCSK9i on endothelial function of T2DM patients under regular use of empagliflozin.
Trial registration


ClinicalTrials.gov identifier: NCT03932721.",2020,The primary endpoint was defined as the change in the 1-min flow-mediated dilation (FMD) after 16 weeks of treatment.,"['\n\n\nPatients with type 2 diabetes mellitus (T2DM', 'T2DM patients under regular use of', 'diabetes', 'T2DM patients who are on regular treatment by SGLT2-i.\nMethods\n\n\nThe EXCEED-BHS3', 'Participants ( n \u2009=\u2009110']","['empagliflozin', 'empagliflozin 25\u2009mg/day alone or empagliflozin 25\u2009mg/day plus evolocumab 140\u2009mg every 2\u2009weeks in addition to optimal medical care', 'PCSK9i', 'evolocumab plus empagliflozin', 'proprotein convertase subtilisin/kexin 9 inhibitor (PCSK9i) therapy']","['change in the 1-min flow-mediated dilation (FMD', 'plasma levels of nitric oxide, vascular cell adhesion molecule-1 and isoprostane, high-density lipoprotein (HDL) and low-density lipoprotein subfractions profile, HDL function, blood pressure, body mass index, waist circumference and adipokines', 'FMD change after ischemia/reperfusion injury protocol (reserve FMD', 'change in FMD and reserve FMD']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1505133', 'cui_str': 'SLC5A2 protein, human'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4517536', 'cui_str': '110'}]","[{'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C3848772', 'cui_str': 'empagliflozin 25 MG [Jardiance]'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C3529352', 'cui_str': 'evolocumab'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}, {'cui': 'C0496675', 'cui_str': 'Medical care'}, {'cui': 'C1100660', 'cui_str': 'Proprotein Convertase'}, {'cui': 'C0038601', 'cui_str': 'Subtilisins'}, {'cui': 'C0165249', 'cui_str': 'Kexin'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0016052', 'cui_str': 'Fibromuscular dysplasia'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0078056', 'cui_str': 'Lymphocyte antigen CD106'}, {'cui': 'C0949860', 'cui_str': 'Isoprostane'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0578543', 'cui_str': 'Low density lipoprotein subfraction'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C1955907', 'cui_str': 'Adipokine'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0035126', 'cui_str': 'Ischemia-reperfusion injury'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]",,0.0973208,The primary endpoint was defined as the change in the 1-min flow-mediated dilation (FMD) after 16 weeks of treatment.,"[{'ForeName': 'Ikaro', 'Initials': 'I', 'LastName': 'Breder', 'Affiliation': 'Atherosclerosis and Vascular Biology Laboratory, Cardiology Department, State University of Campinas, SP, Brazil.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Cunha Breder', 'Affiliation': 'Atherosclerosis and Vascular Biology Laboratory, Cardiology Department, State University of Campinas, SP, Brazil.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Bonilha', 'Affiliation': 'Atherosclerosis and Vascular Biology Laboratory, Cardiology Department, State University of Campinas, SP, Brazil.'}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Munhoz', 'Affiliation': 'Atherosclerosis and Vascular Biology Laboratory, Cardiology Department, State University of Campinas, SP, Brazil.'}, {'ForeName': 'Sheila T Kimura', 'Initials': 'STK', 'LastName': 'Medorima', 'Affiliation': 'Atherosclerosis and Vascular Biology Laboratory, Cardiology Department, State University of Campinas, SP, Brazil.'}, {'ForeName': 'Daniela C', 'Initials': 'DC', 'LastName': 'Oliveira', 'Affiliation': 'Atherosclerosis and Vascular Biology Laboratory, Cardiology Department, State University of Campinas, SP, Brazil.'}, {'ForeName': 'Helison R', 'Initials': 'HR', 'LastName': 'do Carmo', 'Affiliation': 'Atherosclerosis and Vascular Biology Laboratory, Cardiology Department, State University of Campinas, SP, Brazil.'}, {'ForeName': 'Camila', 'Initials': 'C', 'LastName': 'Moreira', 'Affiliation': 'Atherosclerosis and Vascular Biology Laboratory, Cardiology Department, State University of Campinas, SP, Brazil.'}, {'ForeName': 'Anatol', 'Initials': 'A', 'LastName': 'Kontush', 'Affiliation': 'UMR-ICAN 1166, National Institute for Health and Medical Research (INSERM), Sorbonne University, Paris, France.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Zimetti', 'Affiliation': 'Department of Food and Drugs, University of Parma, Parma, Emilia-Romagna, Italy.'}, {'ForeName': 'Ilaria', 'Initials': 'I', 'LastName': 'Zanotti', 'Affiliation': 'Department of Food and Drugs, University of Parma, Parma, Emilia-Romagna, Italy.'}, {'ForeName': 'Luiz Sergio F', 'Initials': 'LSF', 'LastName': 'Carvalho', 'Affiliation': 'Atherosclerosis and Vascular Biology Laboratory, Cardiology Department, State University of Campinas, SP, Brazil.'}, {'ForeName': 'Wilson', 'Initials': 'W', 'LastName': 'Nadruz', 'Affiliation': 'Atherosclerosis and Vascular Biology Laboratory, Cardiology Department, State University of Campinas, SP, Brazil.'}, {'ForeName': 'Elza', 'Initials': 'E', 'LastName': 'Muscelli', 'Affiliation': 'Atherosclerosis and Vascular Biology Laboratory, Cardiology Department, State University of Campinas, SP, Brazil.'}, {'ForeName': 'Thiago', 'Initials': 'T', 'LastName': 'Quinaglia', 'Affiliation': 'Atherosclerosis and Vascular Biology Laboratory, Cardiology Department, State University of Campinas, SP, Brazil.'}, {'ForeName': 'Andrei C', 'Initials': 'AC', 'LastName': 'Sposito', 'Affiliation': 'Brazilian Heart Study Group, Cardiology Division, State University of Campinas, Rua Tessália Vieira de Camargo, 126., Cidade Universitária Zeferino Vaz, Campinas, São Paulo, 13084-971, Brazil.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Therapeutic advances in chronic disease,['10.1177/2040622320959248']
3436,33062284,"The effects of exergaming on pain, postural control, technology acceptance and flow experience in older people with chronic musculoskeletal pain: a randomised controlled trial.","Background


Older people with chronic musculoskeletal pain are at risk of falls. This study aimed to investigate the effects of exergaming on pain and postural control in older people with chronic musculoskeletal pain. Secondary outcomes were technology acceptance, flow experience, perceived physical exertion, expended mental effort and heart rate.
Methods


Fifty four older adults (age: 71 ± 5 years) with chronic musculoskeletal pain were randomised into 2 groups. Group 1 received exergaming training using the Interactive Rehabilitation and Exercise System (IREX®). Group 2 undertook traditional gym-based exercise (TGB). Both groups completed twice weekly 40-min exercise sessions for 6 weeks. Perceived pain was measured using a numeric pain rating scale and the Multidimensional Affect and Pain Survey questionnaire. Postural control was measured as sway using a Kistler™ force platform. Technology acceptance was measured with the Unified Theory of Acceptance and Use of Technology questionnaire and flow experience with the Flow State Scale. Physiological measures of perceived physical exertion, expended mental effort and heart rate were recorded during all sessions.
Results


The exergaming group demonstrated significant reductions in pain intensity and thermal pain including a near significant approach in physical engagement in comparison to TGB group. Although no intervention effects on postural control were found, the exergaming group showed significant improvements in three sway measures (AP SD, ML SD and AP range) over time whereas significant improvements in ML range were found in the TGB group. Relating to technology acceptance, significant intervention effects on social influence and behavioural intention were found in the TGB group instead, although both groups demonstrated increases of acceptance over time. Regarding flow experience, concentration at task was significantly influenced in the TGB group and significant increases in flow variables over time were observed in both groups. Significant increases over time in perceived physical exertion and expended mental effort were found in both groups.
Conclusion


Our findings support the potential of exergaming to alleviate pain and improve balance in older people with chronic musculoskeletal pain. Both forms of exercise are acceptable, intrinsically motivating and show evidence of benefit to older people with chronic musculoskeletal pain.
Trial registration


ClinicalTrials.gov Identifier: NCT04029285 (retrospectively registered, July 23, 2019).",2020,"Although no intervention effects on postural control were found, the exergaming group showed significant improvements in three sway measures (AP SD, ML SD and AP range) over time whereas significant improvements in ML range were found in the TGB group.","['\n\n\nOlder people with chronic musculoskeletal pain', 'older people with chronic musculoskeletal pain', 'four older adults (age: 71\u2009±\u20095\u2009years) with chronic musculoskeletal pain']","['traditional gym-based exercise (TGB', 'TGB', 'exergaming training using the Interactive Rehabilitation and Exercise System (IREX®']","['technology acceptance, flow experience, perceived physical exertion, expended mental effort and heart rate', 'postural control', 'numeric pain rating scale and the Multidimensional Affect and Pain Survey questionnaire', 'pain, postural control, technology acceptance and flow experience', 'Technology acceptance', 'three sway measures (AP SD, ML SD and AP range', 'social influence and behavioural intention', 'pain intensity and thermal pain', 'Physiological measures of perceived physical exertion, expended mental effort and heart rate', 'time in perceived physical exertion and expended mental effort', 'pain and postural control', 'physical engagement', 'Postural control', 'Perceived pain']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0746683', 'cui_str': 'Chronic musculoskeletal pain'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0031807', 'cui_str': 'Physical Effort'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C4760618', 'cui_str': 'Posture Control'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}]",54.0,0.0811072,"Although no intervention effects on postural control were found, the exergaming group showed significant improvements in three sway measures (AP SD, ML SD and AP range) over time whereas significant improvements in ML range were found in the TGB group.","[{'ForeName': 'Jae-Llane', 'Initials': 'JL', 'LastName': 'Ditchburn', 'Affiliation': 'Institute of Science, Natural Resources and Outdoor Studies, University of Cumbria, Fusehill Street, Carlisle, Cumbria, CA1 2HH UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'van Schaik', 'Affiliation': 'School of Social Sciences, Humanities and Law, Teesside University, Middlesbrough, TS1 3BA UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Dixon', 'Affiliation': 'School of Health and Life Sciences, Teesside University, Middlesbrough, TS1 3BX UK.'}, {'ForeName': 'Alasdair', 'Initials': 'A', 'LastName': 'MacSween', 'Affiliation': 'School of Health and Life Sciences, Teesside University, Middlesbrough, TS1 3BX UK.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Martin', 'Affiliation': 'School of Health and Life Sciences, Teesside University, Middlesbrough, TS1 3BX UK.'}]","BMC sports science, medicine & rehabilitation",['10.1186/s13102-020-00211-x']
3437,33062294,"Implementation of a trauma-informed, evidence-informed intervention for Latinx families experiencing interpersonal violence and child maltreatment: protocol for a pilot randomized control trial of SafeCare+®.","Background


A consistently demonstrated overlap exists between the occurrence of domestic violence and child maltreatment, yet these issues are historically addressed by distinct systems and programming. The randomized control trial pilot study presented in this article adapts, implements, and tests a new approach for addressing family violence for Latinx families with co-occurring risk for domestic violence and child maltreatment. In doing so, this pilot study addresses the clear need for collaboration between the two fields and focuses on Latinx families, who often face specific challenges regarding seeking and receiving needed services. The primary aim of the current study is a pilot implementation of SafeCare+®, an evidence-based parenting curriculum (SafeCare®) augmented with a healthy relationships curriculum (SafeCare+®). The objectives are a reduction of family violence, improved communication, and a healthy home environment for children in Latinx families with co-occurring domestic violence and child maltreatment.
Methods


This protocol outlines a feasibility, randomized control trial to examine the potential efficacy of SafeCare+. The pilot study is divided into two phases. Components of phase one involve developing a detailed implementation and evaluation plan, including a community needs assessment, determining screening and outcome measures, and assuring all components are culturally appropriate for the target population. Phase two implements the randomization of parents, who are involved in the child welfare system and referred for in-home parenting services, into SafeCare+ or SafeCare as usual. Participants complete assessments regarding mental health, provider-parent relationship, interpersonal violence experiences, and fidelity to the intervention. Analyses will focus on improvement on target outcomes for the intervention group, as well as comparison to the control group.
Discussion


This study will provide evidence on the feasibility and potential effectiveness of an early intervention program aimed at improving communication skills and mental health and reducing incidents of violence for Latinx parents who are involved with the child welfare service system. The findings of the study will inform the decision to progress to a full scale, definitive randomized control trial to test the effectiveness of an intervention, delivered as part of home visitation, for improving outcomes for families with histories of domestic violence.
Trial registration


ClinicalTrials.gov, NCT03041558; registered 2 February, 2017-retrospectively registered.",2020,"The objectives are a reduction of family violence, improved communication, and a healthy home environment for children in Latinx families with co-occurring domestic violence and child maltreatment.
","['children in Latinx families with co-occurring domestic violence and child maltreatment', 'Latinx families experiencing interpersonal violence and child maltreatment', 'Latinx families with co-occurring risk for domestic violence and child maltreatment', 'Latinx parents who are involved with the child welfare service system', 'families with histories of domestic violence']","['SafeCare', 'SafeCare+®', 'SafeCare+®, an evidence-based parenting curriculum (SafeCare®) augmented with a healthy relationships curriculum (SafeCare+®']","['mental health, provider-parent relationship, interpersonal violence experiences, and fidelity to the intervention']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0206073', 'cui_str': 'Domestic violence'}, {'cui': 'C0008060', 'cui_str': 'Child abuse'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0008093', 'cui_str': 'Child Well Being'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C1445903', 'cui_str': 'History of domestic violence'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",,0.0622027,"The objectives are a reduction of family violence, improved communication, and a healthy home environment for children in Latinx families with co-occurring domestic violence and child maltreatment.
","[{'ForeName': 'Danielle L', 'Initials': 'DL', 'LastName': 'Fettes', 'Affiliation': 'Department of Psychiatry, University of California, 9500 Gilman Drive, #0812, La Jolla, San Diego, CA 92093 USA.'}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Aarons', 'Affiliation': 'Department of Psychiatry, University of California, 9500 Gilman Drive, #0812, La Jolla, San Diego, CA 92093 USA.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Brew', 'Affiliation': 'South Bay Community Services, San Diego, CA USA.'}, {'ForeName': 'Karla', 'Initials': 'K', 'LastName': 'Ledesma', 'Affiliation': 'South Bay Community Services, San Diego, CA USA.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Silovsky', 'Affiliation': 'Health Sciences Center, The University of Oklahoma, Oklahoma City, OK USA.'}]",Pilot and feasibility studies,['10.1186/s40814-020-00681-3']
3438,33062295,Feasibility study on pre or postoperative accelerated radiotherapy (POP-ART) in breast cancer patients.,"Background


In early-stage breast cancer, the cornerstone of treatment is surgery. After breast-conserving surgery, adjuvant radiotherapy has shown to improve locoregional control and overall survival rates. The use of breast radiotherapy in the preoperative (preop) setting is far less common. Nevertheless, it might improve disease-free survival as compared to postoperative radiotherapy. There is also a possibility of downsizing the tumour which might lead to a lower need for mastectomy. There are some obstacles that complicate its introduction into daily practice. It may complicate surgery or lead to an increase in wound complications or delayed wound healing. Another fear of preop radiotherapy is delaying surgery for too long. At Ghent University Hospital, we have experience with a 5-fraction radiotherapy schedule allowing radiotherapy delivery in a very short time span.
Methods


Twenty female breast cancer patients with non-metastatic disease receiving preop chemotherapy will be randomized between preop or postoperative radiotherapy. The feasibility of preop radiotherapy will be evaluated based on overall treatment time. All patients will be treated in 5 fractions of 5.7 Gy to the whole breast with a simultaneous integrated boost to the tumour/tumour bed of 5 × 6.2 Gy. In case of lymph node irradiation, the lymph node regions will receive a dose of 27 Gy in 5 fractions of 5.4 Gy. The total duration of therapy will be 10 to 12 days. In the preop group, overall treatment time is defined as the time between diagnosis and the day of last surgery, in the postop group between diagnosis and last irradiation fraction. Toxicity related to surgery, radio-, and chemotherapy will be evaluated on dedicated case-report forms at predefined time points. Tumour response will be evaluated on the pathology report and on MRI at baseline and in the interval between chemotherapy and surgery.
Discussion


The primary objective of the trial is to investigate the feasibility of preop radiotherapy. Secondary objectives are to search for biomarkers of response and toxicity and identify the involved cell death mechanisms and the effect of preop breast radiotherapy on the in-situ immune micro-environment.",2020,"After breast-conserving surgery, adjuvant radiotherapy has shown to improve locoregional control and overall survival rates.","['Twenty female breast cancer patients with non-metastatic disease receiving preop', 'breast cancer patients']","['breast-conserving surgery, adjuvant radiotherapy', 'preop radiotherapy', 'postoperative radiotherapy', 'breast radiotherapy', 'pre or postoperative accelerated radiotherapy (POP-ART', 'chemotherapy']","['wound complications', 'total duration of therapy', 'locoregional control and overall survival rates', 'Toxicity', 'disease-free survival', 'overall treatment time']","[{'cui': 'C0235653', 'cui_str': 'Malignant neoplasm of female breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}]","[{'cui': 'C0917927', 'cui_str': 'Breast conserving surgery'}, {'cui': 'C0242939', 'cui_str': 'Adjuvant Radiotherapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0852216', 'cui_str': 'Breast radiotherapies'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0439820', 'cui_str': 'Popping sensation quality'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0444921', 'cui_str': 'Duration of treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",20.0,0.0506089,"After breast-conserving surgery, adjuvant radiotherapy has shown to improve locoregional control and overall survival rates.","[{'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Van Hulle', 'Affiliation': 'Department of Human Structure and Repair, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Vakaet', 'Affiliation': 'Department of Human Structure and Repair, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Giselle', 'Initials': 'G', 'LastName': 'Post', 'Affiliation': 'Department of Human Structure and Repair, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Annick', 'Initials': 'A', 'LastName': 'Van Greveling', 'Affiliation': 'Department of Radiation Oncology, Ghent University Hospital, C. Heymanslaan 10, 9000 Ghent, Belgium.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Monten', 'Affiliation': 'Department of Human Structure and Repair, Ghent University, Ghent, Belgium.'}, {'ForeName': 'An', 'Initials': 'A', 'LastName': 'Hendrix', 'Affiliation': 'Department of Human Structure and Repair, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Koen', 'Initials': 'K', 'LastName': 'Van de Vijver', 'Affiliation': 'Department of Pathology, Ghent University Hospital, C. Heymanslaan 10, 9000 Ghent, Belgium.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Van Dorpe', 'Affiliation': 'Department of Pathology, Ghent University Hospital, C. Heymanslaan 10, 9000 Ghent, Belgium.'}, {'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'De Visschere', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Ghent University Hospital, C. Heymanslaan 10, 9000 Ghent, Belgium.'}, {'ForeName': 'Geert', 'Initials': 'G', 'LastName': 'Braems', 'Affiliation': 'Department of Human Structure and Repair, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Katrien', 'Initials': 'K', 'LastName': 'Vandecasteele', 'Affiliation': 'Department of Human Structure and Repair, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Hannelore', 'Initials': 'H', 'LastName': 'Denys', 'Affiliation': 'Department of Internal Medicine and Pediatrics, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Wilfried', 'Initials': 'W', 'LastName': 'De Neve', 'Affiliation': 'Department of Human Structure and Repair, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Liv', 'Initials': 'L', 'LastName': 'Veldeman', 'Affiliation': 'Department of Human Structure and Repair, Ghent University, Ghent, Belgium.'}]",Pilot and feasibility studies,['10.1186/s40814-020-00693-z']
3439,33062629,Bioequivalence of the pharmacokinetics between tofacitinib aspartate and tofacitinib citrate in healthy subjects.,"Tofacitinib is an oral disease-modifying anti-rheumatic drug to selectively inhibit Janus kinases. Tofacitinib is a representative small molecule inhibitor that is used to treat many diseases including rheumatoid arthritis and various autoimmune conditions. Unlike biological agents, tofacitinib has several advantages, including the ability to be administered orally and a short half-life. This study aimed to evaluate the bioequivalence of the pharmacokinetics (PK) between tofacitinib aspartate 7.13 mg (test formulation) and tofacitinib citrate 8.08 mg (reference formulation; Xeljanz®) in healthy subjects. A randomized, open-label, single-dose, 2-sequence, 2-period, 2-treatment crossover trial was conducted in 41 healthy volunteers. A total of 5 mg of tofacitinib as the test or the reference formulation was administered, and serial blood samples were collected up to 14 hours after dosing for PK analyses. The plasma concentration of tofacitinib was determined by ultra-performance liquid chromatography-tandem mass spectrometry. A non-compartmental analysis was used to estimate the PK parameters. A total of 35 subjects completed the study and the study drug was well-tolerated. The mean maximum concentration (C max ) and area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC last ) for the test formulation were 52.67 ng/mL and 133.86 ng∙h/mL, respectively, and 50.61 ng/mL and 133.49 h∙ng/mL for the reference formulation, respectively. The geometric mean ratios (90% confidence intervals) of the C max  and AUC last  between the 2 formulations were 1.041 (0.944-1.148) and 1.003 (0.968-1.039), respectively. Tofacitinib aspartate exhibited bioequivalent PK profiles to those of the reference formulation.
Trial Registration


ClinicalTrials.gov Identifier: NCT04278391.",2020,"AUC last  between the 2 formulations were 1.041 (0.944-1.148) and 1.003 (0.968-1.039), respectively.","['41 healthy volunteers', '35 subjects completed the study and the study drug was well-tolerated', 'healthy subjects']","['Tofacitinib aspartate', 'tofacitinib aspartate and tofacitinib citrate', 'Tofacitinib', 'tofacitinib citrate 8.08 mg (reference formulation; Xeljanz®', 'tofacitinib']","['mean maximum concentration (C max ) and area under the concentration-time curve', 'geometric mean ratios', 'plasma concentration of tofacitinib']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}]","[{'cui': 'C2930696', 'cui_str': 'tofacitinib'}, {'cui': 'C0085845', 'cui_str': 'Aspartate'}, {'cui': 'C2987431', 'cui_str': 'Tofacitinib citrate'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C3505045', 'cui_str': 'Xeljanz'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C2930696', 'cui_str': 'tofacitinib'}]",41.0,0.0899696,"AUC last  between the 2 formulations were 1.041 (0.944-1.148) and 1.003 (0.968-1.039), respectively.","[{'ForeName': 'Wonsuk', 'Initials': 'W', 'LastName': 'Shin', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, CHA Bundang Medical Center, CHA University School of Medicine, Seongnam 13496, Korea.'}, {'ForeName': 'A-Young', 'Initials': 'AY', 'LastName': 'Yang', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, CHA Bundang Medical Center, CHA University School of Medicine, Seongnam 13496, Korea.'}, {'ForeName': 'Hyeonji', 'Initials': 'H', 'LastName': 'Yun', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, CHA Bundang Medical Center, CHA University School of Medicine, Seongnam 13496, Korea.'}, {'ForeName': 'Doo-Yeoun', 'Initials': 'DY', 'LastName': 'Cho', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, CHA Bundang Medical Center, CHA University School of Medicine, Seongnam 13496, Korea.'}, {'ForeName': 'Kyung Hee', 'Initials': 'KH', 'LastName': 'Park', 'Affiliation': 'Clinical Development Center, Daewoong Pharmaceutical Co., Ltd., Seoul 06170, Korea.'}, {'ForeName': 'Hyunju', 'Initials': 'H', 'LastName': 'Shin', 'Affiliation': 'Formulation Research Team, Daewoong Pharmaceutical Co., Ltd., Seoul 06170, Korea.'}, {'ForeName': 'Anhye', 'Initials': 'A', 'LastName': 'Kim', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, CHA Bundang Medical Center, CHA University School of Medicine, Seongnam 13496, Korea.'}]",Translational and clinical pharmacology,['10.12793/tcp.2020.28.e13']
3440,33062729,The effect of educational intervention on health-promoting lifestyle: Intervention mapping approach.,"BACKGROUND


The health-promoting lifestyle by empowering individuals will increase control over their health, improve quality of life, and prevent diseases. The purpose of the present study was to determine the effect of the educational intervention based on the intervention mapping approach on health-promoting lifestyle in Iranian college students.
METHODS


This study is a quasi-experimental control study that was conducted in two groups of 65 students of Iran University of Medical Sciences in 2018-2019. The data were collected using the Health-Promoting Lifestyle Standard Profile II questionnaire and a researcher-made questionnaire based on the mapping approach, whose validity and reliability were confirmed. The educational intervention was designed according to the pretest results, including five training sessions and performed for the intervention group. The two groups were evaluated with the same questionnaires 1 month and 3 months later, and the data were analyzed using independent  t -test, Spearman, ANCOVA, ANOVA test, and covariance.
Results


Before the intervention, no significant difference was observed between the mean scores of health-promoting behaviors in the two groups, but after the intervention, the mean scores of attitude, subjective norms, enabling factors, and perceived self-efficacy and mean scores of health-promoting lifestyle and its dimensions increased significantly in the intervention group ( P  < 0.001) compared to the control group.
Conclusion


The educational intervention is effective in improving behaviors related to health-promoting lifestyle and its dimensions. Therefore, performing educational interventions are suggested to adopt and adhere to behaviors related to health-promoting lifestyle by utilizing and reinforcing perceived self-efficacy, subjective norms, enabling factors, and attitudinal change.",2020,"Before the intervention, no significant difference was observed between the mean scores of health-promoting behaviors in the two groups, but after the intervention, the mean scores of attitude, subjective norms, enabling factors, and perceived self-efficacy and mean scores of health-promoting lifestyle and its dimensions increased significantly in the intervention group ( P  < 0.001) compared to the control group.
","['two groups of 65 students of Iran University of Medical Sciences in 2018-2019', 'Iranian college students']",['educational intervention'],"['mean scores of attitude, subjective norms, enabling factors, and perceived self-efficacy and mean scores of health-promoting lifestyle and its dimensions', 'health-promoting lifestyle', 'mean scores of health-promoting behaviors']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0557806', 'cui_str': 'College'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0237750', 'cui_str': 'Societal Norms'}, {'cui': 'C0014024', 'cui_str': 'Enabling Factors'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0517496', 'cui_str': 'Health promotion behavior'}]",,0.0137438,"Before the intervention, no significant difference was observed between the mean scores of health-promoting behaviors in the two groups, but after the intervention, the mean scores of attitude, subjective norms, enabling factors, and perceived self-efficacy and mean scores of health-promoting lifestyle and its dimensions increased significantly in the intervention group ( P  < 0.001) compared to the control group.
","[{'ForeName': 'Mahnaz', 'Initials': 'M', 'LastName': 'Solhi', 'Affiliation': 'Air Pollution Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Farbod Ebadi', 'Initials': 'FE', 'LastName': 'Fard Azar', 'Affiliation': 'Health Promotion Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Jamileh', 'Initials': 'J', 'LastName': 'Abolghasemi', 'Affiliation': 'Department of Biostatistics, School of Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mina', 'Initials': 'M', 'LastName': 'Maheri', 'Affiliation': 'Department of Public Health, School of Health, Reproductive Health Research Center, Urmia University of Medical Sciences, Urmia, Iran.'}, {'ForeName': 'Seyed Fahim', 'Initials': 'SF', 'LastName': 'Irandoost', 'Affiliation': 'Department of Public Health, School of Health, Urmia University of Medical Sciences, Urmia, Iran.'}, {'ForeName': 'Saeede', 'Initials': 'S', 'LastName': 'Khalili', 'Affiliation': 'PhD Candidate of Education and Health Promotion, School of Health, Iran University of Medical Sciences, Tehran, Iran.'}]",Journal of education and health promotion,['10.4103/jehp.jehp_768_19']
3441,33062730,Evaluating the effect of Pender's health promotion model on self-efficacy and treatment adherence behaviors among patients undergoing hemodialysis.,"INTRODUCTION


Health promotion through lifestyle improvement is an important topic that has received considerable attention from the scientific community worldwide. This study aimed to determine the effect of Pender's health promotion model on self-efficacy and treatment adherence behaviors of hemodialysis patients in Shahrekord, Iran, in 2018-2019.
METHODS


This quasi-experimental study was performed on 70 hemodialysis patients who were attending routine hemodialysis sessions in Hajar hospital in Shahrekord. Individuals were selected by simple random sampling and randomly assigned to two groups of control and intervention. In the preintervention stage, all patients completed a questionnaire that was prepared to collect demographic information and measure health-promoting behaviors, self-efficacy, and treatment adherence. The intervention group participated in eight sessions of a health promotion model-based education program. Both groups were asked to complete the questionnaire again immediately after the intervention and also 2 months later.
RESULTS


The repeated measures analysis of variance (ANOVA) showed a significant difference between the two groups in terms of the extent of change in mean scores over the three measurement stages (before the intervention, after the intervention, and 2 months after the intervention) ( P  < 0.001). A statistically significant difference was observed between the two groups in terms of self-efficacy scores in the postintervention and follow-up stages ( P  < 0.05). The repeated measures ANOVA also revealed a significant difference between the two groups in terms of the extent of change in mean treatment adherence scores over the three measurement stages ( P  < 0.001).
CONCLUSION


Considering the positive effects of the program on patients undergoing hemodialysis, it is recommended to use the program to promote the well-being of these patients without time restrictions.",2020,A statistically significant difference was observed between the two groups in terms of self-efficacy scores in the postintervention and follow-up stages ( P  < 0.05).,"['patients undergoing hemodialysis', 'hemodialysis patients in Shahrekord, Iran, in 2018-2019', '70 hemodialysis patients who were attending routine hemodialysis sessions in Hajar hospital in Shahrekord']","[""Pender's health promotion model"", 'health promotion model-based education program']","['self-efficacy scores', 'self-efficacy and treatment adherence behaviors', 'collect demographic information and measure health-promoting behaviors, self-efficacy, and treatment adherence', 'mean treatment adherence scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0018738', 'cui_str': 'Health promotion'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4505265', 'cui_str': 'Therapeutic Adherence'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0517496', 'cui_str': 'Health promotion behavior'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",70.0,0.0174381,A statistically significant difference was observed between the two groups in terms of self-efficacy scores in the postintervention and follow-up stages ( P  < 0.05).,"[{'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Masoudi', 'Affiliation': 'Community-Oriented Nursing Midwifery Research Center, Shahrekord University of Medical Sciences, Shahrekord, Iran.'}, {'ForeName': 'Masood', 'Initials': 'M', 'LastName': 'Lotfizade', 'Affiliation': 'Social Determinants of Health Research Center, Shahrekord University of Medical Sciences, Shahrekord, Iran.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Gheysarieha', 'Affiliation': 'Department of Health Education and Health Promotion, Shahrekord University of Medical Sciences, Shahrekord, Iran.'}, {'ForeName': 'Leili', 'Initials': 'L', 'LastName': 'Rabiei', 'Affiliation': 'Social Determinants of Health Research Center, Shahrekord University of Medical Sciences, Shahrekord, Iran.'}]",Journal of education and health promotion,['10.4103/jehp.jehp_747_19']
3442,33062733,The impact of education on attachment skills in the promotion of happiness among women with unplanned pregnancy.,"BACKGROUND


Happiness is among the factors that promote mental health in mothers with unplanned pregnancy. The present study aimed to determine the impact of attachment skills training on happiness among women with unplanned pregnancy.
MATERIALS AND METHODS


This clinical trial was conducted on 84 women with unplanned pregnancy referred to three prenatal clinics in Shiraz in 2018. The participants were randomly divided into an intervention group and a control group using permutation block. At first, the participants were requested to sign written informed consent form, demographic information form, and mental health questionnaire. Then, they were asked to complete Oxford Happiness Questionnaire and Cranley's Maternal-Fetal Attachment Scale. The intervention group received attachment training through six 90-min sessions, while the control group underwent the hospital's routine care. The two groups were required to fill out the study questionnaires once more after 4 weeks after the intervention. After all, the data were analyzed using Chi-square test, Fisher's exact test, independent  t -test, and ANOVA.
RESULTS


There was a significant difference between the two groups' pretest and posttest mean scores of happiness ( P  = 0.0001). The results showed that in the experimental group, pretraining and posttraining period mean scores were 89.64 (7.2) and 93.13 (6.09), respectively; while in the control group, pretraining and posttraining period mean scores were, respectively, 91.69 (9.96) and 91 (8.82). The difference between the two groups was statistically significant. No significant relationship was observed between happiness and the couples' occupations, number of pregnancies, and number of miscarriages in the two groups ( P  > 0.05).
CONCLUSION


The mean score of happiness increased after the training, being significantly different from that in the control group. Therefore, happiness is a changeable feature that can be promoted among pregnant women via interventional methods.",2020,"No significant relationship was observed between happiness and the couples' occupations, number of pregnancies, and number of miscarriages in the two groups ( P  > 0.05).
","['pregnant women via interventional methods', '84 women with unplanned pregnancy referred to three prenatal clinics in Shiraz in 2018', 'women with unplanned pregnancy', 'mothers with unplanned pregnancy']","['attachment skills training', ""attachment training through six 90-min sessions, while the control group underwent the hospital's routine care"", 'control group using permutation block']","['mean score of happiness', ""happiness and the couples' occupations, number of pregnancies, and number of miscarriages"", ""complete Oxford Happiness Questionnaire and Cranley's Maternal-Fetal Attachment Scale"", 'pretraining and posttraining period mean scores']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0041747', 'cui_str': 'Unplanned pregnancy'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0026591', 'cui_str': 'Mother'}]","[{'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0028811', 'cui_str': 'Occupation'}, {'cui': 'C0600457', 'cui_str': 'Gravida'}, {'cui': 'C0429916', 'cui_str': 'Number of miscarriages'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",84.0,0.0415981,"No significant relationship was observed between happiness and the couples' occupations, number of pregnancies, and number of miscarriages in the two groups ( P  > 0.05).
","[{'ForeName': 'Fahimeh', 'Initials': 'F', 'LastName': 'Hasanzadeh', 'Affiliation': 'Department of Midwifery, School of Nursing and Midwifery, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Maasumeh', 'Initials': 'M', 'LastName': 'Kaviani', 'Affiliation': 'Department of Midwifery, Community Based Psychiatric Care Research Center, School of Nursing and Midwifery, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Marzieh', 'Initials': 'M', 'LastName': 'Akbarzadeh', 'Affiliation': 'Department of Midwifery, Maternal-Fetal Medicine Research Center, School of Nursing and Midwifery, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",Journal of education and health promotion,['10.4103/jehp.jehp_740_19']
3443,33062765,Preliminary Results From a US Clinical Trial of a Novel Synthetic Polymer Meniscal Implant.,"Background


At least 760,000 outpatient meniscectomies are performed in the United States each year, making this the most common musculoskeletal procedure. However, meniscal resection can alter the joint biomechanics and overload the articular cartilage, which may contribute to degenerative changes and the need for knee replacement. Avoiding or delaying knee replacement is particularly important in younger or more active patients. Synthetic meniscal implants have been developed in an attempt to restore the natural joint biomechanics, alleviate pain and disability, and potentially minimize degenerative changes in patients who require meniscectomy.
Purpose


To evaluate the preliminary results from 2 ongoing trials that are evaluating the safety and effectiveness of a synthetic polymer meniscal implant (NUsurface; Active Implants, LLC).
Study Design


Cohort study; Level of evidence, 2.
Methods


This was a preliminary analysis of the first 100 patients enrolled across 2 studies for 12 months: a single-arm, intervention-only study and a randomized controlled trial comparing the investigational meniscal implant with nonsurgical therapy. There were 65 patients in the implant group (30 randomized) and 35 in the control group. Outcomes included Knee injury and Osteoarthritis Outcome Score (KOOS) and adverse events (AEs) collected at baseline and follow-up visits of 6 weeks, 6 months, and 12 months.
Results


No statistically significant differences were found in baseline characteristics between the implant and control groups. At 12 months, follow-up KOOS data were available for 87% of the 100 included patients. Significantly greater improvements from baseline were observed in the implant group compared with controls in all KOOS subcomponents, except for symptoms (119%-177% greater improvement at 12 months). AEs were reported at similar rates between the 2 groups, with 12 AEs among 11 patients in the implant group (16.9%) versus 5 AEs among 5 patients (14.3%) in the control group ( P  = .99).
Conclusion


These preliminary results suggest significant improvements in pain and function scores with the implant over nonsurgical therapy and a similar adverse event rate.",2020,"Significantly greater improvements from baseline were observed in the implant group compared with controls in all KOOS subcomponents, except for symptoms (119%-177% greater improvement at 12 months).","['younger or more active patients', 'patients who require meniscectomy', '100 patients enrolled across 2 studies for 12 months: a single-arm, intervention-only study', '65 patients in the implant group (30 randomized) and 35 in the control group']","['investigational meniscal implant with nonsurgical therapy', 'synthetic polymer meniscal implant (NUsurface; Active Implants, LLC']","['Knee injury and Osteoarthritis Outcome Score (KOOS) and adverse events (AEs', 'pain and function scores', 'safety and effectiveness']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0187901', 'cui_str': 'Chondrectomy of semilunar cartilage of knee'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0440257', 'cui_str': 'Synthetic polymer'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C3476088', 'cui_str': 'Knee Injury and Osteoarthritis Outcome Score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",100.0,0.154458,"Significantly greater improvements from baseline were observed in the implant group compared with controls in all KOOS subcomponents, except for symptoms (119%-177% greater improvement at 12 months).","[{'ForeName': 'Brian P', 'Initials': 'BP', 'LastName': 'McKeon', 'Affiliation': 'Boston Sports & Shoulder Center, Waltham, Massachusetts, USA.'}, {'ForeName': 'Kenneth R', 'Initials': 'KR', 'LastName': 'Zaslav', 'Affiliation': 'Ortho Virginia, Virginia Commonwealth University, Richmond, Virginia, USA.'}, {'ForeName': 'Richard H', 'Initials': 'RH', 'LastName': 'Alfred', 'Affiliation': 'The Bone & Joint Center and Albany Medical College, Albany, New York, USA.'}, {'ForeName': 'R Maxwell', 'Initials': 'RM', 'LastName': 'Alley', 'Affiliation': 'The Bone & Joint Center and Albany Medical College, Albany, New York, USA.'}, {'ForeName': 'Richard H', 'Initials': 'RH', 'LastName': 'Edelson', 'Affiliation': 'Sports Medicine Oregon, Tigard, Oregon, USA.'}, {'ForeName': 'Wayne K', 'Initials': 'WK', 'LastName': 'Gersoff', 'Affiliation': 'Advanced Orthopedic and Sports Medicine Specialists, Denver, Colorado, USA.'}, {'ForeName': 'Jonathan E', 'Initials': 'JE', 'LastName': 'Greenleaf', 'Affiliation': 'Sports Medicine Oregon, Tigard, Oregon, USA.'}, {'ForeName': 'Christopher C', 'Initials': 'CC', 'LastName': 'Kaeding', 'Affiliation': 'Sports Medicine Institute and Department of Orthopaedics, The Ohio State University Wexner Medical Center, Columbus, Ohio, USA.'}]",Orthopaedic journal of sports medicine,['10.1177/2325967120952414']
3444,33062830,Developing Adult Sepsis Protocol to Reduce the Time to Initial Antibiotic Dose and Improve Outcomes among Patients with Cancer in Emergency Department.,"Objective


Sepsis is a common cause of noncancer-related deaths among oncology patients. Delay in the initiation of efficient antimicrobial therapy will decrease the survival rate. This study aims to develop a sepsis protocol for adult oncology patients to decrease the time needed to receive the initial dose of antibiotic in an emergency department (ED), improve the early recognition of sepsis, and decrease the in-hospital mortality rate due to sepsis.
Methods


A quasi-experimental research design was used. A total of 168 participants were assigned into pre- and post-intervention groups ( n  = 85) and ( n  = 83), respectively. The quick Sequential Organ Failure Assessment screening tool was used to screen patients in the triage room.
Results


There was a significant difference in the proportions of receiving the initial antibiotic dose whether ≤1 h or >1 h between pre- and post-intervention groups. The results also showed that 89.4% of the postintervention group received their initial antibiotic dose in <1 h compared with 10.8% of the preintervention group. The median time needed for administering the initial antibiotic dose was decreased from 95 min to 45 min. The results of the changes in mortality rates are promising as it decreased 11.7% after applying the adult sepsis protocol.
Conclusions


Applying an adult sepsis protocol in the ED significantly decreased the time needed to initiate antibiotic treatment. It is recommended to utilize a multidisciplinary and systematic approach in screening and treating sepsis.",2020,"The results of the changes in mortality rates are promising as it decreased 11.7% after applying the adult sepsis protocol.
","['adult oncology patients', 'Patients with Cancer in Emergency Department', 'screen patients in the triage room', '168 participants']",[],"['median time needed for administering the initial antibiotic dose', 'mortality rates', 'initial antibiotic dose', 'time needed to initiate antibiotic treatment', 'proportions of receiving the initial antibiotic dose', 'survival rate']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0040861', 'cui_str': 'Triage'}, {'cui': 'C4319556', 'cui_str': '168'}]",[],"[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",168.0,0.0781337,"The results of the changes in mortality rates are promising as it decreased 11.7% after applying the adult sepsis protocol.
","[{'ForeName': 'Mustafa Z', 'Initials': 'MZ', 'LastName': 'Bader', 'Affiliation': 'Department of Nursing, King Hussein Cancer Center, Amman, Jordan.'}, {'ForeName': 'Abdullah T', 'Initials': 'AT', 'LastName': 'Obaid', 'Affiliation': 'Department of Nursing, King Hussein Cancer Center, Amman, Jordan.'}, {'ForeName': 'Hisham M', 'Initials': 'HM', 'LastName': 'Al-Khateb', 'Affiliation': 'Department of Nursing, King Hussein Cancer Center, Amman, Jordan.'}, {'ForeName': 'Yazeed T', 'Initials': 'YT', 'LastName': 'Eldos', 'Affiliation': 'Weill Cornell Medicine, Qatar.'}, {'ForeName': 'Moath M', 'Initials': 'MM', 'LastName': 'Elaya', 'Affiliation': 'Department of Nursing, King Hussein Cancer Center, Amman, Jordan.'}]",Asia-Pacific journal of oncology nursing,['10.4103/apjon.apjon_32_20']
3445,33062835,Effectiveness of Education Program on Nursing Knowledge and Attitude toward Pain Management.,"Objective


Nurses have an integral role in pain assessment and management. Adequate knowledge and positive attitudes toward pain management are essential to provide high-quality nursing care for cancer pain. The purposes of this study are to evaluate nurses' knowledge and attitude toward cancer-related pain and to assess the effectiveness of a pain management education program on nurses' knowledge and attitude toward pain.
Methods


A quantitative, experimental design was used.
Results


The total number of participants who were surveyed at three measurement points was 131, with a completion rate of 87.3%. Findings revealed that the score of knowledge and attitude toward cancer-related pain ranged from 14 to 35, with a mean of 23.6 (standard deviation [SD] = 4.38). The mean scores of the intervention group and the control group at two measurement points regarding knowledge and attitude toward cancer-related pain were 32.7 (SD = 2.8) and 32.8 (SD = 4.3) and 23 (SD = 5.5) and 22.2 (SD = 3.8), respectively. There were significant differences at three measurement points among the intervention group ( F  = 114.3,  P  < 0.0005). There were no differences in the three measurement points among the control group ( F  = 3.4,  P  = 0.055).
Conclusions


Nurses have essential roles in cancer pain. A pain management education program can improve nurses' knowledge and attitude toward cancer-related pain.",2020,"There were no differences in the three measurement points among the control group ( F  = 3.4,  P  = 0.055).
",[],"['Education Program', 'pain management education program']","['knowledge and attitude toward cancer-related pain', 'score of knowledge and attitude toward cancer-related pain', ""nurses' knowledge and attitude toward cancer-related pain"", 'mean scores', 'Nursing Knowledge and Attitude toward Pain Management']",[],"[{'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C1276796', 'cui_str': 'Pain management education'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0596240', 'cui_str': 'Cancer pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]",,0.0252336,"There were no differences in the three measurement points among the control group ( F  = 3.4,  P  = 0.055).
","[{'ForeName': 'Aqel', 'Initials': 'A', 'LastName': 'El-Aqoul', 'Affiliation': 'Department of Nursing, King Hussein Cancer Center, Amman, Jordan.'}, {'ForeName': 'Abdullah', 'Initials': 'A', 'LastName': 'Obaid', 'Affiliation': 'Department of Nursing, King Hussein Cancer Center, Amman, Jordan.'}, {'ForeName': 'Ihsan', 'Initials': 'I', 'LastName': 'Jarrah', 'Affiliation': 'Department of Nursing, King Hussein Cancer Center, Amman, Jordan.'}, {'ForeName': 'Khaled', 'Initials': 'K', 'LastName': 'Al-Rawashdeh', 'Affiliation': 'Department of Nursing, King Hussein Cancer Center, Amman, Jordan.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Al Hroub', 'Affiliation': 'Department of Nursing, King Hussein Cancer Center, Amman, Jordan.'}]",Asia-Pacific journal of oncology nursing,['10.4103/apjon.apjon_17_20']
3446,33062871,Improper Communication Makes for Squat: A Qualitative Study of the Health-Care Processes Experienced By Older Adults in a Clinical Trial for Back Pain.,"Background


The study focused on perceptions of older adults toward the healthcare processes they experienced during a clinical trial for back pain that involved family medicine residents and licensed chiropractors.
Methods


Individual semi-structured interviews were conducted with 115 older adults after a 12-week, 3-arm, randomized controlled trial. Two researchers conducted thematic analysis with inductive coding using qualitative software to identify participants' salient experiences of the doctor-patient relationship, healthcare process, and collaboration between study providers. Investigators categorized thematic codes within an existing framework of clinical excellence in primary care.
Results


Participants emphasized provider communication and interpersonal relationships, professionalism and passion for patient care, clinical and diagnostic acumen, and skillful negotiation of the health-care system. Older adults also described the importance of interdisciplinary collaboration and their preferences for receiving hands-on treatments for musculoskeletal conditions.
Conclusion


These older adults valued doctors who communicated clearly and spent time listening to their concerns. Many participants appreciated clinicians who supported an active role for patients in their health-care and who provided touch-based care for musculoskeletal conditions.",2020,"Two researchers conducted thematic analysis with inductive coding using qualitative software to identify participants' salient experiences of the doctor-patient relationship, healthcare process, and collaboration between study providers.","['Older adults', 'Health-Care Processes Experienced By Older Adults in a Clinical Trial for Back Pain', 'older adults toward the healthcare processes they experienced during a clinical trial for back pain that involved family medicine residents and licensed chiropractors', '115 older adults', 'Squat']",[],"['provider communication and interpersonal relationships, professionalism and passion for patient care, clinical and diagnostic acumen, and skillful negotiation of the health-care system']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0347984', 'cui_str': 'During'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0334952', 'cui_str': 'Chiropractor'}, {'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}]",[],"[{'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0815219', 'cui_str': 'Professionalism'}, {'cui': 'C0939808', 'cui_str': 'Passion flower extract'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0680727', 'cui_str': 'Mediation'}, {'cui': 'C0018696', 'cui_str': 'Healthcare Systems'}]",2.0,0.0515191,"Two researchers conducted thematic analysis with inductive coding using qualitative software to identify participants' salient experiences of the doctor-patient relationship, healthcare process, and collaboration between study providers.","[{'ForeName': 'Breanne M', 'Initials': 'BM', 'LastName': 'Wells', 'Affiliation': 'Technique Department, Palmer College of Chiropractic, Davenport, IA, USA.'}, {'ForeName': 'Stacie A', 'Initials': 'SA', 'LastName': 'Salsbury', 'Affiliation': 'Palmer Center for Chiropractic Research, Palmer College of Chiropractic, Davenport, IA, USA.'}, {'ForeName': 'Lia M', 'Initials': 'LM', 'LastName': 'Nightingale', 'Affiliation': 'Life Sciences Department, Palmer College of Chiropractic, Davenport, IA, USA.'}, {'ForeName': 'Dustin C', 'Initials': 'DC', 'LastName': 'Derby', 'Affiliation': 'College Administration, Palmer College of Chiropractic, Davenport, IA, USA.'}, {'ForeName': 'Dana J', 'Initials': 'DJ', 'LastName': 'Lawrence', 'Affiliation': 'Parker Research Institute, Parker University, Dallas, TX, USA.'}, {'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Goertz', 'Affiliation': 'Spine Institute for Quality, Oskaloosa, IA, USA.'}]",Journal of patient experience,['10.1177/2374373519860347']
3447,33062915,The effect of low-dose aspirin on the pregnancy rate in frozen-thawed embryo transfer cycles: A randomized clinical trial.,"Background


The results of previous studies on the effect of low-dose aspirin in frozen-thawed embryo transfer (FET) cycles are limited and controversial.
Objective


To evaluate the effect of low-dose aspirin on the clinical pregnancy in the FET cycles.
Materials and Methods


This study was performed as a randomized clinical trial from May 2018 to February 2019; 128 women who were candidates for the FET were randomly assigned to two groups receiving either 80 mg oral aspirin (n = 64) or no treatment. The primary outcome was clinical pregnancy rate and secondary outcome measures were the implantation rate, miscarriage rate, and endometrial thickness.
Results


The endometrial thickness was lower in patients who received aspirin in comparison to the control group. There were statistically significant differences between the two groups (p = 0.018). Chemical and clinical pregnancy rates and abortion rate was similar in the two groups and there was no statistically significant difference.
Conclusion


The administration of aspirin in FET cycles had no positive effect on the implantation and the chemical and clinical pregnancy rates, which is in accordance with current Cochrane review that does not recommend aspirin administration as a routine in assisted reproductive technology cycles.",2020,"The administration of aspirin in FET cycles had no positive effect on the implantation and the chemical and clinical pregnancy rates, which is in accordance with current Cochrane review that does not recommend aspirin administration as a routine in assisted reproductive technology cycles.","['May 2018 to February 2019; 128 women who were candidates for the FET', 'frozen-thawed embryo transfer cycles']","['80 mg oral aspirin', 'low-dose aspirin', 'aspirin']","['Chemical and clinical pregnancy rates and abortion rate', 'clinical pregnancy rate', 'endometrial thickness', 'implantation rate, miscarriage rate, and endometrial thickness', 'pregnancy rate']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0016701', 'cui_str': 'Freezing'}, {'cui': 'C0013938', 'cui_str': 'Embryo transfer'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}]","[{'cui': 'C0220806', 'cui_str': 'Chemical'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0000794', 'cui_str': 'Abortion Rate'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}]",,0.256188,"The administration of aspirin in FET cycles had no positive effect on the implantation and the chemical and clinical pregnancy rates, which is in accordance with current Cochrane review that does not recommend aspirin administration as a routine in assisted reproductive technology cycles.","[{'ForeName': 'Robab', 'Initials': 'R', 'LastName': 'Davar', 'Affiliation': 'Research and Clinical Center for Infertility, Yazd Reproductive Sciences Institute, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Soheila', 'Initials': 'S', 'LastName': 'Pourmasumi', 'Affiliation': 'Non-Communicable Diseases Research Center, Rafsanjan University of Medical Sciences, Rafsanjan, Iran.'}, {'ForeName': 'Banafsheh', 'Initials': 'B', 'LastName': 'Mohammadi', 'Affiliation': 'Research and Clinical Center for Infertility, Yazd Reproductive Sciences Institute, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Maryam Mortazavi', 'Initials': 'MM', 'LastName': 'Lahijani', 'Affiliation': 'Research and Clinical Center for Infertility, Yazd Reproductive Sciences Institute, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}]",International journal of reproductive biomedicine,['10.18502/ijrm.v13i9.7664']
3448,33062918,Effect of embryo transfer depth on IVF/ICSI outcomes: A randomized clinical trial.,"Background


Although there has been remarkable advancement in the field of assisted reproductive technology, implantation failure remains a significant issue in most infertile couples receiving these treatments. Embryo transfer is important in assisted reproductive technology and directly affects the implantation rates and pregnancy outcomes.
Objective


To assess the effect of two different distance embryo transfer sites from fundal endometrial surface on the outcomes of in-vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI) cycles.
Materials and Methods


A total of 180 women who were candidate for IVF/ ICSI/ embryo transfer in Yazd Research and Clinical Center for Infertility were equally assigned to two groups based on the distance between the fundal endometrial surface and catheter tip to investigate implantation, chemical and clinical pregnancy (group A: 15  ±  5 mm and group B: 25  ±  5 mm, respectively).
Results


The subjects in the group B showed significantly higher implantation rate, chemical and clinical pregnancy rate compared to the group A (p = 0.03, 0.01, 0.04, respectively). The rate of ongoing pregnancy and miscarriage indicated no significant differences between groups (p = 0.21, 0.27, respectively).
Conclusion


In conclusion, our study showed that the depth of embryo replacement inside the uterine cavity at a distance of 25  ±  5 mm beneath fundal endometrial surface have better effects on the pregnancy outcomes of IVF/ICSI cycles and can be considered as an important factor to improve the success of IVF cycles.",2020,"The rate of ongoing pregnancy and miscarriage indicated no significant differences between groups (p = 0.21, 0.27, respectively).
","['infertile couples receiving these treatments', '180 women who were candidate for IVF/ ICSI/ embryo transfer in Yazd Research and Clinical Center for Infertility']","['fundal endometrial surface and catheter tip to investigate implantation, chemical and clinical pregnancy', 'embryo transfer depth']","['IVF/ICSI outcomes', 'implantation rate, chemical and clinical pregnancy rate', 'vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI) cycles', 'rate of ongoing pregnancy and miscarriage']","[{'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0021135', 'cui_str': 'In Vitro'}, {'cui': 'C0037868', 'cui_str': 'Spermatozoa'}, {'cui': 'C0013938', 'cui_str': 'Embryo transfer'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0444299', 'cui_str': 'Catheter tip'}, {'cui': 'C1292732', 'cui_str': 'Investigates'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0220806', 'cui_str': 'Chemical'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0013938', 'cui_str': 'Embryo transfer'}, {'cui': 'C0205125', 'cui_str': 'Deep'}]","[{'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0455164', 'cui_str': 'IVF - In vitro fertilization with intracytoplasmic sperm injection (ICSI)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0220806', 'cui_str': 'Chemical'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0015914', 'cui_str': 'Fertilization'}, {'cui': 'C0021135', 'cui_str': 'In Vitro'}, {'cui': 'C0037868', 'cui_str': 'Spermatozoa'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}]",180.0,0.205851,"The rate of ongoing pregnancy and miscarriage indicated no significant differences between groups (p = 0.21, 0.27, respectively).
","[{'ForeName': 'Robab', 'Initials': 'R', 'LastName': 'Davar', 'Affiliation': 'Research and Clinical Center for Infertility, Yazd Reproductive Sciences Institute, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Seyedeh Mahsa', 'Initials': 'SM', 'LastName': 'Poormoosavi', 'Affiliation': 'Department of Histology, School of Medicine, Dezful University of Medical Sciences, Dezful, Iran.'}, {'ForeName': 'Fereshteh', 'Initials': 'F', 'LastName': 'Mohseni', 'Affiliation': 'Research and Clinical Center for Infertility, Yazd Reproductive Sciences Institute, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Sima', 'Initials': 'S', 'LastName': 'Janati', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medicine, Dezful University of Medical Sciences, Dezful, Iran.'}]",International journal of reproductive biomedicine,['10.18502/ijrm.v13i9.7667']
3449,33063961,[Antiangiogenic therapy in the surgical treatment of pterygium].,"PURPOSE


To evaluate the effectiveness and safety of adjuvant anti-VEGF therapy in the surgical treatment of pterygium, and to determine the indications for its use.
MATERIAL AND METHODS


The study included 67 patients (69 eyes) with grade II-IV pterygium. Patients age was 58.8±12.6 years on average. Best corrected visual acuity (BCVA) varied between 0.01 and 1.0 (0.77±0.24). The patients were divided into 3 groups. The first group included 19 patients (19 eyes) with grade II-III pterygium who underwent «bare sclera» surgery and used aflibercept as adjuvant therapy. The second group included 21 patients (21 eyes) with grade II-IV pterygium who underwent auto conjunctival grafting surgery with no adjuvant therapy. The third group included 27 patients (29 eyes) with grade II-IV pterygium who had it removed in combination with single-time peripheral lamellar keratoplasty (PLK) and underwent adjuvant aflibercept therapy.
RESULTS


Among patients who underwent pterygium excision with adjuvant antiangiogenic therapy there were 5 cases (26%) of relapse during the observation period (23.38±8.96 months), among patients after pterygium excision with auto conjunctival plastic surgery - also 5 cases (24%) of relapse, and among patients who underwent LKP combined with anti-VEGF therapy there was only 1 case (3%) of relapse. Astigmatism has decreased by 0.24±0.5 ( p =0.052) in the first group, by 1.21±1.0 ( p <0.05) in the second group, and by 1.64±1.54 ( p <0.05) in the third group compared with pre-surgical values, thus increasing average BCVA in all 3 patient groups by 0.1±0.13, 0.07±0.11 and 0.15±0.15, respectively.
CONCLUSION


The use of anti-VEGF agents as adjuvant therapy in the surgical treatment of pterygium is a safe method of reducing postoperative inflammation, fibrovascular proliferation and, subsequently, the amount of relapses.",2020,"Astigmatism has decreased by 0.24±0.5 ( p =0.052) in the first group, by 1.21±1.0 ( p <0.05) in the second group, and by 1.64±1.54 ( p <0.05) in the third group compared with pre-surgical values, thus increasing average BCVA in all 3 patient groups by 0.1±0.13, 0.07±0.11 and 0.15±0.15, respectively.
","['67 patients (69 eyes) with grade II-IV pterygium', 'Patients age was 58.8±12.6 years on average', '21 patients (21 eyes) with grade II-IV pterygium who underwent', '19 patients (19 eyes) with grade II-III pterygium who underwent «bare sclera» surgery and used', '27 patients (29 eyes) with grade II-IV pterygium who had it removed in combination with single-time peripheral lamellar keratoplasty (PLK) and underwent adjuvant aflibercept therapy']","['anti-VEGF agents', 'adjuvant anti-VEGF therapy', 'Antiangiogenic therapy', 'aflibercept as adjuvant therapy', 'LKP combined with anti-VEGF therapy', 'pterygium excision with adjuvant antiangiogenic therapy', 'auto conjunctival grafting surgery with no adjuvant therapy']","['Best corrected visual acuity (BCVA', 'average BCVA']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0033999', 'cui_str': 'Pterygium'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0036410', 'cui_str': 'Scleral structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0022591', 'cui_str': 'Lamellar keratoplasty'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C4727874', 'cui_str': 'Anti-VEGF therapy'}, {'cui': 'C2363719', 'cui_str': 'Antiangiogenic therapy'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0197133', 'cui_str': 'Simple excision of pterygium'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}]",67.0,0.0129914,"Astigmatism has decreased by 0.24±0.5 ( p =0.052) in the first group, by 1.21±1.0 ( p <0.05) in the second group, and by 1.64±1.54 ( p <0.05) in the third group compared with pre-surgical values, thus increasing average BCVA in all 3 patient groups by 0.1±0.13, 0.07±0.11 and 0.15±0.15, respectively.
","[{'ForeName': 'S A', 'Initials': 'SA', 'LastName': 'Malozhen', 'Affiliation': 'Research Institute of Eye Diseases, Moscow, Russia.'}, {'ForeName': 'S V', 'Initials': 'SV', 'LastName': 'Trufanov', 'Affiliation': 'Research Institute of Eye Diseases, Moscow, Russia.'}, {'ForeName': 'D A', 'Initials': 'DA', 'LastName': 'Krakhmaleva', 'Affiliation': 'Research Institute of Eye Diseases, Moscow, Russia.'}]",Vestnik oftalmologii,['10.17116/oftalma2020136052177']
3450,33064100,Effect of a Mobile App for the Pharmacotherapeutic Follow-Up of Patients With Cancer on Their Health Outcomes: Quasi-Experimental Study.,"BACKGROUND


Oral antineoplastic agents (OAAs) have revolutionized cancer management. However, they have been reported with adverse side effects and drug-drug interactions. Moreover, patient adherence to OAA treatment is critical. Mobile apps can enable remote and real-time pharmacotherapeutic monitoring of patients, while also promoting patient autonomy in their health care.
OBJECTIVE


The primary objective was to analyze the effect of using a mobile app for the follow-up of patients with oncohematological malignancies undergoing treatment with OAAs on their health outcomes. The secondary objectives were to analyze the role of the app in communication with health care professionals and patient satisfaction with the app.
METHODS


We performed a comparative, quasi-experimental study based on a prepost intervention with 101 patients (control group, n=51, traditional pharmacotherapeutic follow-up vs intervention group, n=50, follow-up through e-OncoSalud, a custom-designed app that promotes follow-up at home and the safety of patients receiving OAAs). The effect of this app on drug safety, adherence to treatment, and quality of life was evaluated.
RESULTS


With regard to drug safety, 73% (37/51) of the patients in the control group and 70% (35/50) of the patients in the intervention group (P=.01) presented with drug-related problems. The probability of detecting an insufficiently treated health problem in the intervention group was significantly higher than that in the control group (P=.04). The proportion of patients who presented with side effects in the intervention group was significantly lower than that in the control group (P>.99). In the control group, 49% (25/51) of the patients consumed some health resources during the first 6 months of treatment compared with 36% (18/50) of the patients in the intervention group (P=.76). Adherence to treatment was 97.6% (SD 7.9) in the intervention group, which was significantly higher than that in the control group (92.9% [SD 10.0]; P=.02). The EuroQol-5D in the intervention group yielded a mean (SD) index of 0.875 (0.156), which was significantly higher than that in the control group (0.741 [0.177]; P<.001). Approximately 60% (29/50) of the patients used the messaging module to communicate with pharmacists. The most frequent types of messages were acknowledgments (77/283, 27.2%), doubts about contraindications and interactions with OAAs (70/283, 24.7%), and consultations for adverse reactions to treatment (39/283, 13.8%). The satisfaction with the app survey conducted in the intervention group yielded an overall mean (SD) score of 9.1 (0.4) out of 10.
CONCLUSIONS


Use of e-OncoSalud for the real-time follow-up of patients receiving OAAs facilitated the optimization of some health outcomes. The intervention group had significantly higher health-related quality of life and adherence to treatment than the control group. Further, the probability of the intervention group presenting with side effects was significantly lower than that of the control group.",2020,The probability of detecting an insufficiently treated health problem in the intervention group was significantly higher than that in the control group (P=.04).,"['101 patients (control group, n=51', 'Patients With Cancer on Their Health Outcomes', 'patients with oncohematological malignancies undergoing treatment with OAAs on their health outcomes']","['Mobile App', 'traditional pharmacotherapeutic follow-up vs intervention group, n=50, follow-up through e-OncoSalud, a custom-designed app that promotes follow-up at home and the safety of patients receiving OAAs']","['overall mean (SD) score', 'drug safety, adherence to treatment, and quality of life', 'mean (SD) index', 'side effects', 'health resources', 'higher health-related quality of life and adherence', 'probability of detecting an insufficiently treated health problem']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003392', 'cui_str': 'Antineoplastic agent'}]","[{'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0162343', 'cui_str': 'Customs'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003392', 'cui_str': 'Antineoplastic agent'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0018741', 'cui_str': 'Health Resources'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0033213', 'cui_str': 'Problem'}]",,0.0447273,The probability of detecting an insufficiently treated health problem in the intervention group was significantly higher than that in the control group (P=.04).,"[{'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Collado-Borrell', 'Affiliation': 'Hospital General Universitario Gregorio Marañon, Madrid, Spain.'}, {'ForeName': 'Vicente', 'Initials': 'V', 'LastName': 'Escudero-Vilaplana', 'Affiliation': 'Hospital General Universitario Gregorio Marañon, Madrid, Spain.'}, {'ForeName': 'Almudena', 'Initials': 'A', 'LastName': 'Ribed', 'Affiliation': 'Hospital General Universitario Gregorio Marañon, Madrid, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Gonzalez-Anleo', 'Affiliation': 'Hospital Clinic Barcelona, Barcelona, Spain.'}, {'ForeName': 'Maite', 'Initials': 'M', 'LastName': 'Martin-Conde', 'Affiliation': 'Hospital Clinic Barcelona, Barcelona, Spain.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Romero-Jimenez', 'Affiliation': 'Hospital General Universitario Gregorio Marañon, Madrid, Spain.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Iglesias-Peinado', 'Affiliation': 'Faculty of Pharmacy, Universidad Complutense de Madrid, Madrid, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Herranz-Alonso', 'Affiliation': 'Hospital General Universitario Gregorio Marañon, Madrid, Spain.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Sanjurjo-Saez', 'Affiliation': 'Hospital General Universitario Gregorio Marañon, Madrid, Spain.'}]",JMIR mHealth and uHealth,['10.2196/20480']
3451,33064101,High-Intensity Interval Aerobic Resistance Training to Counteract Low Relative Appendicular Lean Soft Tissue Mass in Middle Age: Study Protocol for a Randomized Controlled Trial.,"BACKGROUND


Sarcopenia is the age-related loss of skeletal muscle mass and function and may exist in early middle age. Previous research in this area has focused on resistance training in older individuals; however, there is a lack of intervention trials in middle-aged adults with low relative appendicular lean soft tissue mass who may be at risk for sarcopenia in older age.
OBJECTIVE


This randomized controlled trial aims to determine the effects of a high-intensity interval aerobic resistance training intervention on appendicular lean soft tissue mass in middle-aged adults with low relative appendicular lean soft tissue mass.
METHODS


We will conduct a 40-week, single-blinded randomized controlled trial in 84 middle-aged adults with low appendicular lean soft tissue mass in the wider Dunedin area, New Zealand. We will randomly allocate participants to receive either a group-based, 20-week high-intensity interval aerobic resistance training intervention program or a single, 60-minute education session on current exercise recommendations. After the first 20 weeks, both groups will be given a 20-week home program. The study will assess primary and secondary outcome measures, including body composition (regional and whole-body lean soft tissue mass, fat mass, percentage body fat, measured by dual x-ray absorptiometry), blood biomarkers (cortisol, creatinine, C-reactive protein, lipid profile, hemoglobin), physical fitness (maximum oxygen consumption, blood pressure), physical activity (accelerometry), physical function (handgrip strength, sit-to-stand, gait speed, quadriceps strength), and self-reported questionnaires (health outcomes, self-efficacy, perceived enjoyment of physical activity, and multifactorial lifestyle), at baseline, 20 weeks, and 40 weeks. Physical function and self-reported questionnaires will also be measured at 10 weeks. We will assess the primary outcome measure, total body lean soft tissue mass, at baseline, 20 weeks, and 40 weeks. Analyses will be performed using intention-to-treat principles, comparing the outcomes resulting from the intervention, using linear mixed models.
RESULTS


We obtained ethical approval for this study from The University of Otago Human Ethics Committee on December 10, 2018. Participant recruitment started on February 11, 2019 and was completed on May 14, 2019. Data collection started on February 25, 2019 and was completed on February 28, 2020. We expect to publish the results in January 2021.
CONCLUSIONS


High-intensity interval aerobic resistance training is a time-efficient form of exercise, enabling busy middle-aged adults to meet physical activity recommendations while maximizing training results. The findings can inform the development of future prevention-focused interventions aimed at counteracting the high prevalence of sarcopenia in the aging population.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry (ACTRN12618001778279); https://tinyurl.com/y555z6fz.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/22989.",2020,"We will assess the primary outcome measure, total body lean soft tissue mass, at baseline, 20 weeks, and 40 weeks.","['middle-aged adults with low relative appendicular lean soft tissue mass', 'older individuals', 'Middle Age', '84 middle-aged adults with low appendicular lean soft tissue mass in the wider Dunedin area, New Zealand', 'middle-aged adults with low relative appendicular lean soft tissue mass who may be at risk for sarcopenia in older age', 'busy middle-aged adults']","['high-intensity interval aerobic resistance training intervention', 'High-Intensity Interval Aerobic Resistance Training', '20-week high-intensity interval aerobic resistance training intervention program or a single, 60-minute education session on current exercise recommendations', 'https://tinyurl.com/y555z6fz', 'High-intensity interval aerobic resistance training']","['total body lean soft tissue mass', 'body composition (regional and whole-body lean soft tissue mass, fat mass, percentage body fat, measured by dual x-ray absorptiometry), blood biomarkers (cortisol, creatinine, C-reactive protein, lipid profile, hemoglobin), physical fitness (maximum oxygen consumption, blood pressure), physical activity (accelerometry), physical function (handgrip strength, sit-to-stand, gait speed, quadriceps strength), and self-reported questionnaires (health outcomes, self-efficacy, perceived enjoyment of physical activity, and multifactorial lifestyle', 'appendicular lean soft tissue mass']","[{'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0457193', 'cui_str': 'Soft tissue mass'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026062', 'cui_str': 'Middle-age'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0872084', 'cui_str': 'Sarcopenia'}, {'cui': 'C0231337', 'cui_str': 'Senility'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C3853333', 'cui_str': 'Sixty minutes'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0457193', 'cui_str': 'Soft tissue mass'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0023676', 'cui_str': 'Life style'}]",84.0,0.169898,"We will assess the primary outcome measure, total body lean soft tissue mass, at baseline, 20 weeks, and 40 weeks.","[{'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Vlietstra', 'Affiliation': 'Department of Medicine, Otago Medical School, Dunedin Campus, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Debra L', 'Initials': 'DL', 'LastName': 'Waters', 'Affiliation': 'Department of Medicine, Otago Medical School, Dunedin Campus, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Lynnette M', 'Initials': 'LM', 'LastName': 'Jones', 'Affiliation': 'School of Physical Education, Sport & Exercise Sciences, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Meredith-Jones', 'Affiliation': 'Department of Medicine, Otago Medical School, Dunedin Campus, University of Otago, Dunedin, New Zealand.'}]",JMIR research protocols,['10.2196/22989']
3452,33064415,Exercise for Weight Loss: Further Evaluating Energy Compensation with Exercise.,"PURPOSE


This study assessed how individuals compensate for energy expended during a 12-wk aerobic exercise intervention, elucidating potential mechanisms and the role exercise dose plays in the compensatory response.
PARTICIPANTS AND DESIGN


Three-arm, randomized controlled trial among sedentary adults age 18 to 40 yr, body mass index of 25 to 35. Groups included six exercise sessions per week, two sessions per week, and sedentary control.
METHODS


Rate of exercise energy expenditure was calculated from a graded exercise test averaged across five heart rate zones. Energy compensation was calculated as the difference between expected weight loss (based on exercise energy expenditure) and changes in fat and fat-free mass (DXA). Resting energy expenditure was assessed via indirect calorimetry and concentrations of acylated ghrelin, leptin, insulin, and Glucagon-like peptide 1 (GLP-1) were assessed fasting and postprandial (six timepoints over 2 h).
RESULTS


The 6-d·wk group expended more energy (2753.5 kcal) and exercised longer (320.5 min) per week than the 2-d·wk group (1490.7 kcal, 1888.8 min, P < 0.05), resulting in greater fat loss compared with the 2-d or control groups (P < 0.05). Exercise groups did not differ in the % or total kcal compensated. Greater decreases in area under the curve (AUC) for acylated ghrelin predicted greater fat loss, regardless of group, energy expended per week, exercise duration, or exercise intensity. Changes in leptin AUC was the only independent predictor for energy compensation, with a greater decrease in leptin AUC predicting less energy compensation. Exercise frequency, energy expended, duration, or intensity did not influence energy compensation.
CONCLUSIONS


Leptin is an important factor in successful weight loss through exercise, with greater postprandial decreases promoting less compensation. Greater amounts of exercise do not influence the compensatory response to an exercise-induced energy deficit.",2020,"Greater decreases in area under the curve (AUC) for acylated ghrelin predicted greater fat loss, regardless of group, energy expended per week, exercise duration, or exercise intensity.","['sedentary adults age 18 to 40 yr, body mass index of 25 to 35']",['aerobic exercise intervention'],"['weight loss', 'greater fat loss', 'area under the curve (AUC', 'fat loss, regardless of group, energy expended per week, exercise duration, or exercise intensity', 'Energy compensation', 'Exercise frequency, energy expended, duration, or intensity', 'Weight Loss', 'leptin AUC', 'indirect calorimetry and concentrations of acylated ghrelin, leptin, insulin, and Glucagon-like peptide 1 (GLP-1']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0152057', 'cui_str': 'Compensation'}, {'cui': 'C0556455', 'cui_str': 'Frequency of exercise'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0006781', 'cui_str': 'Indirect calorimetry'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}]",,0.0556162,"Greater decreases in area under the curve (AUC) for acylated ghrelin predicted greater fat loss, regardless of group, energy expended per week, exercise duration, or exercise intensity.","[{'ForeName': 'Kyle D', 'Initials': 'KD', 'LastName': 'Flack', 'Affiliation': '1Department of Dietetics and Human Nutrition, University of Kentucky, Lexington, KY 2College of Health Sciences and Center for Muscle Biology, University of Kentucky, Lexington, KY.'}, {'ForeName': 'Harry M', 'Initials': 'HM', 'LastName': 'Hays', 'Affiliation': ''}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Moreland', 'Affiliation': ''}, {'ForeName': 'Douglas E', 'Initials': 'DE', 'LastName': 'Long', 'Affiliation': ''}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002376']
3453,33056960,[Comparative study of corneal densitometry values after posterior lamellar keratoplasty].,"Studying clinical and functional outcomes of femtosecond laser-assisted posterior lamellar keratoplasty is an actual problem in endothelial keratoplasty.
PURPOSE


To compare the values of corneal densitometry (CD) as measured by the Scheimpflug camera (Pentacam) following femtosecond laser-assisted Descemet stripping endothelial keratoplasty (DSEK) vs microkeratome-assisted Descemet Stripping Automated Endothelial Keratoplasty (DSAEK).
MATERIAL AND METHODS


The prospective single center randomized study included 37 eyes of 37 patients with Fuchs endothelial dystrophy and cataract. 20 patients underwent cataract phacoemulsification combined with Femto-DSEK; 17 patients of the control group underwent cataract phacoemulsification combined with DSAEK. Outcome measurements included optical coherence tomography of the anterior segment of the eye, endothelial microscopy and densitometry. Optical density of the cornea and its various layers: anterior layer (AL), central layer (CL), posterior layer (PL) and interface zone was assessed in the 0-2 and 2-6 mm zones. The follow-up period lasted 1 year.
RESULTS


Comparative analysis did not reveal statistically significant differences in AL, CL, and CCT values between the groups ( p >0.05). In the Femto-DSEK group, densitometry indices of the posterior layers of the cornea and the interface zone were significantly higher than in the DSAEK group ( p <0.05). Postoperative uncorrected visual acuity (UCVA) and best corrected visual acuity (BCVA) differed significantly throughout all follow-up period with DSAEK group having better results ( p <0.05). Endothelial cell density (ECD) at 12 months was higher in the Femto-DSEK group compared with the DSAEK group (65.7±7.7% and 58.5±8.1%,  p =0.02, respectively).
CONCLUSION


After one year, corneal density values (AL, CL, PL) and CCT were comparable between the groups. UCVA, BSCVA and ECD were significantly better after DSAEK.",2020,Postoperative uncorrected visual acuity (UCVA) and best corrected visual acuity (BCVA) differed significantly throughout all follow-up period with DSAEK group having better results ( p <0.05).,"['37 eyes of 37 patients with Fuchs endothelial dystrophy and cataract', '20 patients underwent']","['cataract phacoemulsification combined with DSAEK', 'cataract phacoemulsification combined with Femto-DSEK', 'Scheimpflug camera (Pentacam) following femtosecond laser-assisted Descemet stripping endothelial keratoplasty (DSEK) vs microkeratome-assisted Descemet Stripping Automated Endothelial Keratoplasty (DSAEK', 'femtosecond laser-assisted posterior lamellar keratoplasty']","['Postoperative uncorrected visual acuity (UCVA) and best corrected visual acuity (BCVA', 'Endothelial cell density (ECD', 'UCVA, BSCVA and ECD', 'densitometry indices of the posterior layers of the cornea and the interface zone', 'Optical density of the cornea and its various layers: anterior layer (AL), central layer (CL), posterior layer (PL) and interface zone', 'values of corneal densitometry (CD', 'corneal density values (AL, CL, PL) and CCT', 'AL, CL, and CCT values', 'optical coherence tomography of the anterior segment of the eye, endothelial microscopy and densitometry']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0016781', 'cui_str': ""Fuchs' corneal dystrophy""}, {'cui': 'C0086543', 'cui_str': 'Cataract'}]","[{'cui': 'C0086543', 'cui_str': 'Cataract'}, {'cui': 'C0282545', 'cui_str': 'Phacoemulsification'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0185047', 'cui_str': 'Stripping'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C2366835', 'cui_str': 'Endothelial keratoplasty'}, {'cui': 'C1719874', 'cui_str': ""Descemet's stripping endothelial keratoplasty""}, {'cui': 'C0179533', 'cui_str': 'Camera'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C1531960', 'cui_str': 'Femtosecond pulsed laser device'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C1260869', 'cui_str': 'Microkeratome'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0022591', 'cui_str': 'Lamellar keratoplasty'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1637380', 'cui_str': 'Uncorrected visual acuity'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0429518', 'cui_str': 'Endothelial cell density'}, {'cui': 'C0011321', 'cui_str': 'Densitometry'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0010031', 'cui_str': 'Corneal structure'}, {'cui': 'C0439164', 'cui_str': 'OD units'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C4049005', 'cui_str': 'Cataract, total congenital with posterior sutural opacities in Heterozygotes'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0003153', 'cui_str': 'Anterior eyeball segment structure'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0026018', 'cui_str': 'Microscopy'}]",37.0,0.0660162,Postoperative uncorrected visual acuity (UCVA) and best corrected visual acuity (BCVA) differed significantly throughout all follow-up period with DSAEK group having better results ( p <0.05).,"[{'ForeName': 'N F', 'Initials': 'NF', 'LastName': 'Shilova', 'Affiliation': 'S.N. Fyodorov National Medical Research Center «MNTK «Eye Microsurgery», Moscow, Russia.'}, {'ForeName': 'N S', 'Initials': 'NS', 'LastName': 'Anisimova', 'Affiliation': 'A.I. Yevdokimov Moscow State University of Medicine and Dentristy, Moscow, Russia.'}, {'ForeName': 'O P', 'Initials': 'OP', 'LastName': 'Antonova', 'Affiliation': 'S.N. Fyodorov National Medical Research Center «MNTK «Eye Microsurgery», Moscow, Russia.'}, {'ForeName': 'S I', 'Initials': 'SI', 'LastName': 'Anisimov', 'Affiliation': 'A.I. Yevdokimov Moscow State University of Medicine and Dentristy, Moscow, Russia.'}, {'ForeName': 'B E', 'Initials': 'BE', 'LastName': 'Malyugin', 'Affiliation': 'S.N. Fyodorov National Medical Research Center «MNTK «Eye Microsurgery», Moscow, Russia.'}]",Vestnik oftalmologii,['10.17116/oftalma202013605125']
3454,33056965,[The influence of long-term retinal protective therapy on glaucoma progression according to structural and functional tests].,"PURPOSE


To evaluate the influence of prolonged neuroprotective therapy on disease progression in patients with primary open-angle glaucoma (POAG) with compensated intraocular pressure (IOP).
MATERIAL AND METHODS


The study included 147 patients with stages I-II POAG (249 eyes) who were randomized into the main (69 patients, 119 eyes) and control groups (78 patients, 130 eyes). Patients of the main group underwent retinalamin treatment course every 6 months. Patients were examined before enrolling and then every 3 months during the 24-months follow-up including optical coherence tomography (OCT; RNFL - retinal nerve fiber layer, NRR - neuroretinal rim, GCL - ganglion cell layer) and static perimetry (MD - mean deviation, PSD - pattern standard deviation).
RESULTS


Visual acuity and refraction did not change in either group ( p >0.05). IOP increased in the control group ( p =0.033). There was no difference between the groups by the 24th month ( p =0.87). No MD changes were noted in the main ( p =0.45) and control groups ( p =0.27). PSD changed in the main (4.84±3.21 and 6.01±2.584 dB in the beginning and the end, respectively,  p =0.0004) and the control groups (3.46±2.23 and 5.86±2.26 dB, respectively;  p <0.0001). The groups differed in MD and PSD initially ( p =0.15;  p =0.02) and became equal by the end ( p =0.59;  p =0.53). RNFL did not change significantly in the main group ( p =0.078) and decreased from 83.5±22.47 to 76.7±20.7 µm in the control group ( p =0.001); no differences between the groups were noted in the beginning ( p =0.276) or in the end of the study ( p =0.524). NRR increased in the main group from 222±88.94 to 231±99.3 ( p =0.012), and decreased in the control group from 248±87.09 to 234±96.2 ( p =0.0006); no differences were found between groups in the beginning or in the end of the study ( p =0.109;  p =0.909). GCL thickness did not change either in the main, or in the control group ( p =0.211;  p =0.16), with no difference between the group noted in the beginning or the end of the study ( p =0.44;  p =0.51).
CONCLUSION


Regular treatment with retinalamin arrests the development of glaucomatous optic neuropathy. Longer-term research is required to study its influence on the visual function and the quality of life.",2020,"NRR increased in the main group from 222±88.94 to 231±99.3 ( p =0.012), and decreased in the control group from 248±87.09 to 234±96.2 ( p =0.0006); no differences were found between groups in the beginning or in the end of the study ( p =0.109;  p =0.909).","['147 patients with stages I-II POAG (249 eyes) who were randomized into the main (69 patients, 119 eyes) and control groups (78 patients, 130 eyes', 'patients with primary open-angle glaucoma (POAG) with compensated intraocular pressure (IOP']","['prolonged neuroprotective therapy', 'long-term retinal protective therapy', 'retinalamin']","['Visual acuity and refraction', 'disease progression', 'GCL thickness', 'glaucoma progression', 'glaucomatous optic neuropathy', 'PSD', 'RNFL', 'MD changes', 'IOP', 'NRR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0339573', 'cui_str': 'Primary open angle glaucoma'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}]","[{'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C1610354', 'cui_str': 'retinalamin'}]","[{'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0429585', 'cui_str': 'Refraction measurement - finding'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0023521', 'cui_str': 'Galactosylceramide beta-galactosidase deficiency'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0029132', 'cui_str': 'Disorder of optic nerve'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}]",147.0,0.0311746,"NRR increased in the main group from 222±88.94 to 231±99.3 ( p =0.012), and decreased in the control group from 248±87.09 to 234±96.2 ( p =0.0006); no differences were found between groups in the beginning or in the end of the study ( p =0.109;  p =0.909).","[{'ForeName': 'V V', 'Initials': 'VV', 'LastName': 'Strakhov', 'Affiliation': 'Yaroslavl State Medical University, Yaroslavl, Russia.'}, {'ForeName': 'E A', 'Initials': 'EA', 'LastName': 'Egorov', 'Affiliation': 'Pirogov Russian National Research Medical University, Moscow, Russia.'}, {'ForeName': 'V P', 'Initials': 'VP', 'LastName': 'Erichev', 'Affiliation': 'Research Institute of Eye Diseases, Moscow, Russia.'}, {'ForeName': 'A V', 'Initials': 'AV', 'LastName': 'Yartsev', 'Affiliation': 'Yaroslavl State Medical University, Yaroslavl, Russia.'}, {'ForeName': 'S Yu', 'Initials': 'SY', 'LastName': 'Petrov', 'Affiliation': 'Research Institute of Eye Diseases, Moscow, Russia.'}, {'ForeName': 'D A', 'Initials': 'DA', 'LastName': 'Dorofeev', 'Affiliation': 'Regional clinical hospital No 3, Chelyabinsk, Russia.'}]",Vestnik oftalmologii,['10.17116/oftalma202013605158']
3455,33057017,Author Correction: Inhaled nitric oxide therapy in acute bronchiolitis: A multicenter randomized clinical trial.,An amendment to this paper has been published and can be accessed via a link at the top of the paper.,2020,An amendment to this paper has been published and can be accessed via a link at the top of the paper.,['acute bronchiolitis'],['nitric oxide therapy'],[],"[{'cui': 'C0001311', 'cui_str': 'Acute bronchiolitis'}]","[{'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]",[],,0.08724,An amendment to this paper has been published and can be accessed via a link at the top of the paper.,"[{'ForeName': 'Aviv', 'Initials': 'A', 'LastName': 'Goldbart', 'Affiliation': 'Saban Pediatric Medical Center, Soroka University Medical Center, Faculty of Health Sciences, Ben-Gurion University, Beer Sheva, Israel. avivgold@bgu.ac.il.'}, {'ForeName': 'Inbal', 'Initials': 'I', 'LastName': 'Golan-Tripto', 'Affiliation': 'Saban Pediatric Medical Center, Soroka University Medical Center, Faculty of Health Sciences, Ben-Gurion University, Beer Sheva, Israel.'}, {'ForeName': 'Giora', 'Initials': 'G', 'LastName': 'Pillar', 'Affiliation': 'Carmel Medical Center, Haifa, Israel.'}, {'ForeName': 'Galit', 'Initials': 'G', 'LastName': 'Livnat-Levanon', 'Affiliation': 'Carmel Medical Center, Haifa, Israel.'}, {'ForeName': 'Ori', 'Initials': 'O', 'LastName': 'Efrati', 'Affiliation': 'Sheba Medical Center, Ramat Gan, Israel.'}, {'ForeName': 'Ronen', 'Initials': 'R', 'LastName': 'Spiegel', 'Affiliation': 'Haemek Medical Center, Afula, Israel.'}, {'ForeName': 'Ronit', 'Initials': 'R', 'LastName': 'Lubetzky', 'Affiliation': ""Dana-Dwek Children's Hospital, Tel Aviv Sourasky Medical Center, Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.""}, {'ForeName': 'Moran', 'Initials': 'M', 'LastName': 'Lavie', 'Affiliation': ""Dana-Dwek Children's Hospital, Tel Aviv Sourasky Medical Center, Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.""}, {'ForeName': 'Lior', 'Initials': 'L', 'LastName': 'Carmon', 'Affiliation': 'Saban Pediatric Medical Center, Soroka University Medical Center, Faculty of Health Sciences, Ben-Gurion University, Beer Sheva, Israel.'}, {'ForeName': 'Abdi', 'Initials': 'A', 'LastName': 'Ghaffari', 'Affiliation': ""Department of Pathology and Molecular Medicine, Queen's University, Kingston, ON, Canada, K7L 3N6.""}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Nahum', 'Affiliation': 'Saban Pediatric Medical Center, Soroka University Medical Center, Faculty of Health Sciences, Ben-Gurion University, Beer Sheva, Israel.'}]",Scientific reports,['10.1038/s41598-020-70779-4']
3456,33055099,Covid-19: Eli Lilly pauses antibody trial for safety reasons.,,2020,,[],[],[],[],[],[],,0.0262004,,"[{'ForeName': 'Owen', 'Initials': 'O', 'LastName': 'Dyer', 'Affiliation': 'Montreal, Canada.'}]",BMJ (Clinical research ed.),['10.1136/bmj.m3985']
3457,33055112,Effect of mHealth tool on knowledge regarding reproductive health of school going adolescent girls: a before-after quasi-experimental study.,"OBJECTIVE


This study was executed to (1) assess the effect of mHealth (mobile health) tool on knowledge regarding reproductive health (RH) of adolescent girls and (2) determine the utilisation of mHealth tool among school girls.
DESIGN


Before-after type of quasi-experimental study.
SETTING


Dhaka North City Corporation in Bangladesh.
PARTICIPANTS


400 adolescent girls aged 14-19 years were selected based on defined criteria.
INTERVENTIONS


Short message service (SMS) intervention on RH was delivered through a mobile phone.
PRIMARY AND SECONDARY OUTCOME MEASURES


8 schools out of 61 were randomly selected in the study area. A total of 400 girls were selected randomly on permission from those schools and parents. SMS interventions were delivered for 8 weeks. The data were collected using a self-administered questionnaire before and after SMS intervention to evaluate the effect. The number of responses to weekly SMS determined mHealth usage or practice.
RESULTS


Postintervention knowledge score (mean 70.8%±9.7%) on RH was significantly higher (paired t=69.721, p<0.001) than preintervention knowledge score (mean 44.71%±9.13%) with a large effect size (cohen's d=3.6). The knowledge score on RH was (p<0.001) correlated (+0.636) with SMS response. Multiple linear regression indicated that increase response to one SMS intervention there was an increase of knowledge score by 2.661% (linear slope 2.66, at 95% CI, p<0.001) after controlling the confounder. The mean knowledge score in all five knowledge segments of RH increased significantly (p<0.001) after SMS intervention.
CONCLUSION


The result indicated that the SMS tool of the mHealth approach is an easy and effective way to improve RH knowledge for adolescent girls. SMS intervention was well accepted by the girls. Thereby this mHealth tool can be chosen to provide health information for a mass approach.",2020,"The mean knowledge score in all five knowledge segments of RH increased significantly (p<0.001) after SMS intervention.
","['Dhaka North City Corporation in Bangladesh', 'school going adolescent girls', 'school girls', '400 girls were selected randomly on permission from those schools and parents', '400 adolescent girls aged 14-19 years were selected based on defined criteria', '8 schools out of 61 were randomly selected in the study area', 'adolescent girls']","['mHealth (mobile health', 'Short message service (SMS) intervention', 'SMS intervention', 'mHealth tool']","['preintervention knowledge score', 'knowledge score on RH', 'knowledge score', 'RH', 'mean knowledge score', 'RH knowledge']","[{'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0521104', 'cui_str': 'With permission of'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0336791', 'cui_str': 'Tool'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0242667', 'cui_str': 'Reproductive Health'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",400.0,0.0282648,"The mean knowledge score in all five knowledge segments of RH increased significantly (p<0.001) after SMS intervention.
","[{'ForeName': 'Tanima', 'Initials': 'T', 'LastName': 'Ahmed', 'Affiliation': 'Community Medicine, Uttara Adhunik Medical College, Dhaka, Bangladesh tanirif@gmail.com.'}]",BMJ open,['10.1136/bmjopen-2019-036656']
3458,33055176,Incentive programmes for smoking cessation: cluster randomized trial in workplaces in Thailand.,"OBJECTIVE


To compare several monetary incentive programmes for promoting smoking abstinence among employees who smoke at workplaces in a middle income country.
DESIGN


Parallel group, open label, assessor blinded, cluster randomized controlled trial.
SETTING


Large industrial workplaces in metropolitan Bangkok, Thailand.
PARTICIPANTS


Employees who smoked cigarettes and planned to quit within six months recruited from 101 worksite clusters (84 different companies).
INTERVENTIONS


Worksites were digitally cluster randomized by an independent investigator to usual care or usual care plus one of eight types of incentive programmes. Usual care consisted of one time group counseling and cessation support through a 28 day text messaging programme. The incentive programmes depended on abstinence at three months and varied on three intervention components: refundable deposits, assignment to a teammate, and bonus size ($20 (£15; €17) or $40).
MAIN OUTCOME MEASURES


The primary outcome was biochemically verified seven day point prevalence smoking abstinence at 12 months. Secondary outcomes were programme acceptance at enrollment and smoking abstinence at three months (end of intervention) and at six months. All randomized participants who had complete baseline information were included in intention-to-treat analyses; participants with missing outcomes were coded as continuing smokers.
RESULTS


Between April 2015 and August 2016, the trial enrolled 4190 participants. Eighteen were omitted because of missing baseline covariates and death before the primary endpoint, therefore 4172 participants were included in the intention-to-treat analyses. Programme acceptance was relatively high across all groups: 58.7% (2451/4172) overall and 61.3% (271/442) in the usual care group. Abstinence rates at 12 months did not differ among deposit programmes (336/2253, 14.9%) and non-deposit programmes (280/1919, 14.6%; adjusted difference 0.8 points, 95% confidence interval -2.7 to 4.3, P=0.65), but were somewhat lower for team based programmes (176/1348, 13.1%) than individual based programmes (440/2824, 15.6%; -3.2 points, -6.6 to -0.2, P=0.07), and higher for $40 bonus programmes (322/1954, 16.5%) than programmes with no bonus (148/1198, 12.4%; 5.9 points, 2.1 to 9.7, P=0.002). The $40 individual bonus was the most efficacious randomization group at all endpoints. Intervention components did not strongly interact with each other.
CONCLUSIONS


Acceptance of monetary incentive programmes for promoting smoking abstinence was high across all groups. The $40 individual bonus programmes increased long term smoking abstinence compared with usual care, although several other incentive designs did not, such as team based programmes and deposit programmes. Incentive design in workplace wellness programmes might influence their effectiveness at reducing smoking rates in low resource settings.
TRIAL REGISTRATION


ClinicalTrials.gov (NCT02421224).",2020,Programme acceptance was relatively high across all groups: 58.7% (2451/4172) overall and 61.3% (271/442) in the usual care group.,"['employees who smoke at workplaces in a middle income country', 'Large industrial workplaces in metropolitan Bangkok, Thailand', 'Employees who smoked cigarettes and planned to quit within six months recruited from 101 worksite clusters (84 different companies', 'All randomized participants who had complete baseline information were included in intention-to-treat analyses; participants with missing outcomes were coded as continuing smokers', 'Between April 2015 and August 2016', '4190 participants', '4172 participants were included in the intention-to-treat analyses']",['Worksites were digitally cluster randomized by an independent investigator to usual care or usual care plus one of eight types of incentive programmes'],"['Programme acceptance', 'Abstinence rates', 'biochemically verified seven day point prevalence smoking abstinence', 'smoking abstinence', 'long term smoking abstinence', 'programme acceptance at enrollment and smoking abstinence']","[{'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0021267', 'cui_str': 'Industry'}, {'cui': 'C0039725', 'cui_str': 'Thailand'}, {'cui': 'C0239059', 'cui_str': 'Cigarette smoke'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0007465', 'cui_str': 'Cause of death'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}]","[{'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}]",4190.0,0.230203,Programme acceptance was relatively high across all groups: 58.7% (2451/4172) overall and 61.3% (271/442) in the usual care group.,"[{'ForeName': 'Justin S', 'Initials': 'JS', 'LastName': 'White', 'Affiliation': 'Philip R Lee Institute for Health Policy Studies, University of California, San Francisco, 3333 California Street, Box 0936, San Francisco, CA 94118, USA justin.white@ucsf.edu.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Lowenstein', 'Affiliation': 'School of Public Health, University of California, Berkeley, CA, USA.'}, {'ForeName': 'Nucharee', 'Initials': 'N', 'LastName': 'Srivirojana', 'Affiliation': 'Institute for Population and Social Research, Mahidol University, Nakhon Pathom, Thailand.'}, {'ForeName': 'Aree', 'Initials': 'A', 'LastName': 'Jampaklay', 'Affiliation': 'Institute for Population and Social Research, Mahidol University, Nakhon Pathom, Thailand.'}, {'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Dow', 'Affiliation': 'School of Public Health, University of California, Berkeley, CA, USA.'}]",BMJ (Clinical research ed.),['10.1136/bmj.m3797']
3459,33055231,Remdesivir against COVID-19 and Other Viral Diseases.,"Patients and physicians worldwide are facing tremendous health care hazards that are caused by the ongoing severe acute respiratory distress syndrome coronavirus 2 (SARS-CoV-2) pandemic. Remdesivir (GS-5734) is the first approved treatment for severe coronavirus disease 2019 (COVID-19). It is a novel nucleoside analog with a broad antiviral activity spectrum among RNA viruses, including ebolavirus (EBOV) and the respiratory pathogens Middle East respiratory syndrome coronavirus (MERS-CoV), SARS-CoV, and SARS-CoV-2. First described in 2016, the drug was derived from an antiviral library of small molecules intended to target emerging pathogenic RNA viruses.  In vivo , remdesivir showed therapeutic and prophylactic effects in animal models of EBOV, MERS-CoV, SARS-CoV, and SARS-CoV-2 infection. However, the substance failed in a clinical trial on ebolavirus disease (EVD), where it was inferior to investigational monoclonal antibodies in an interim analysis. As there was no placebo control in this study, no conclusions on its efficacy in EVD can be made. In contrast, data from a placebo-controlled trial show beneficial effects for patients with COVID-19. Remdesivir reduces the time to recovery of hospitalized patients who require supplemental oxygen and may have a positive impact on mortality outcomes while having a favorable safety profile. Although this is an important milestone in the fight against COVID-19, approval of this drug will not be sufficient to solve the public health issues caused by the ongoing pandemic. Further scientific efforts are needed to evaluate the full potential of nucleoside analogs as treatment or prophylaxis of viral respiratory infections and to develop effective antivirals that are orally bioavailable.",2020,"In vivo , remdesivir showed therapeutic and prophylactic effects in animal models of EBOV, MERS-CoV, SARS-CoV, and SARS-CoV-2 infection.",['patients with COVID-19'],['placebo'],"['EBOV, MERS-CoV, SARS-CoV, and SARS-CoV-2 infection']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0949892', 'cui_str': 'Ebolavirus'}, {'cui': 'C3698360', 'cui_str': 'MERS-CoV'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]",,0.0456724,"In vivo , remdesivir showed therapeutic and prophylactic effects in animal models of EBOV, MERS-CoV, SARS-CoV, and SARS-CoV-2 infection.","[{'ForeName': 'Jakob J', 'Initials': 'JJ', 'LastName': 'Malin', 'Affiliation': 'Department I of Internal Medicine, Division of Infectious Diseases, University of Cologne, Cologne, Germany jakob.malin@uk-koeln.de.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Suárez', 'Affiliation': 'Department I of Internal Medicine, Division of Infectious Diseases, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Priesner', 'Affiliation': 'Department I of Internal Medicine, Division of Infectious Diseases, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Gerd', 'Initials': 'G', 'LastName': 'Fätkenheuer', 'Affiliation': 'Department I of Internal Medicine, Division of Infectious Diseases, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Rybniker', 'Affiliation': 'Department I of Internal Medicine, Division of Infectious Diseases, University of Cologne, Cologne, Germany.'}]",Clinical microbiology reviews,['10.1128/CMR.00162-20']
3460,33055247,Effectiveness of pelvic floor muscle training with and without electromyographic biofeedback for urinary incontinence in women: multicentre randomised controlled trial.,"OBJECTIVE


To assess the effectiveness of pelvic floor muscle training (PFMT) plus electromyographic biofeedback or PFMT alone for stress or mixed urinary incontinence in women.
DESIGN


Parallel group randomised controlled trial.
SETTING


23 community and secondary care centres providing continence care in Scotland and England.
PARTICIPANTS


600 women aged 18 and older, newly presenting with stress or mixed urinary incontinence between February 2014 and July 2016: 300 were randomised to PFMT plus electromyographic biofeedback and 300 to PFMT alone.
INTERVENTIONS


Participants in both groups were offered six appointments with a continence therapist over 16 weeks. Participants in the biofeedback PFMT group received supervised PFMT and a home PFMT programme, incorporating electromyographic biofeedback during clinic appointments and at home. The PFMT group received supervised PFMT and a home PFMT programme. PFMT programmes were progressed over the appointments.
MAIN OUTCOME MEASURES


The primary outcome was self-reported severity of urinary incontinence (International Consultation on Incontinence Questionnaire-urinary incontinence short form (ICIQ-UI SF), range 0 to 21, higher scores indicating greater severity) at 24 months. Secondary outcomes were cure or improvement, other pelvic floor symptoms, condition specific quality of life, women's perception of improvement, pelvic floor muscle function, uptake of other urinary incontinence treatment, PFMT self-efficacy, adherence, intervention costs, and quality adjusted life years.
RESULTS


Mean ICIQ-UI SF scores at 24 months were 8.2 (SD 5.1, n=225) in the biofeedback PFMT group and 8.5 (SD 4.9, n=235) in the PFMT group (mean difference -0.09, 95% confidence interval -0.92 to 0.75, P=0.84). Biofeedback PFMT had similar costs (mean difference £121 ($154; €133), -£409 to £651, P=0.64) and quality adjusted life years (-0.04, -0.12 to 0.04, P=0.28) to PFMT. 48 participants reported an adverse event: for 23 this was related or possibly related to the interventions.
CONCLUSIONS


At 24 months no evidence was found of any important difference in severity of urinary incontinence between PFMT plus electromyographic biofeedback and PFMT alone groups. Routine use of electromyographic biofeedback with PFMT should not be recommended. Other ways of maximising the effects of PFMT should be investigated.
TRIAL REGISTRATION


ISRCTN57756448.",2020,At 24 months no evidence was found of any important difference in severity of urinary incontinence between PFMT plus electromyographic biofeedback and PFMT alone groups.,"['23 community and secondary care centres', 'stress or mixed urinary incontinence in women', 'urinary incontinence in women', '48 participants', '600 women aged 18 and older, newly presenting with stress or mixed urinary incontinence between February 2014 and July 2016: 300']","['pelvic floor muscle training with and without electromyographic biofeedback', 'PFMT', 'electromyographic biofeedback with PFMT', 'PFMT plus electromyographic biofeedback and 300 to PFMT alone', 'supervised PFMT and a home PFMT programme', 'pelvic floor muscle training (PFMT) plus electromyographic biofeedback or PFMT alone', 'supervised PFMT and a home PFMT programme, incorporating electromyographic biofeedback']","['severity of urinary incontinence', ""cure or improvement, other pelvic floor symptoms, condition specific quality of life, women's perception of improvement, pelvic floor muscle function, uptake of other urinary incontinence treatment, PFMT self-efficacy, adherence, intervention costs, and quality adjusted life years"", 'quality adjusted life years', 'self-reported severity of urinary incontinence (International Consultation on Incontinence Questionnaire-urinary incontinence short form (ICIQ-UI SF), range 0 to 21, higher scores indicating greater severity', 'Mean ICIQ-UI SF scores', 'adverse event']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C3494402', 'cui_str': 'Secondary Care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0869256', 'cui_str': 'Mixed urinary incontinence'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C4319604', 'cui_str': '300'}]","[{'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}, {'cui': 'C0204624', 'cui_str': 'Electromyographic biofeedback'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0231484', 'cui_str': 'Muscle function'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C4544471', 'cui_str': 'International Consultation on Incontinence Questionnaire-Urinary Incontinence-Short Form'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",600.0,0.168684,At 24 months no evidence was found of any important difference in severity of urinary incontinence between PFMT plus electromyographic biofeedback and PFMT alone groups.,"[{'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Hagen', 'Affiliation': 'Nursing, Midwifery and Allied Health Professions Research Unit, Glasgow Caledonian University, Glasgow G4 0BA, UK s.hagen@gcu.ac.uk.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Elders', 'Affiliation': 'Nursing, Midwifery and Allied Health Professions Research Unit, Glasgow Caledonian University, Glasgow G4 0BA, UK.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Stratton', 'Affiliation': 'Nursing, Midwifery and Allied Health Professions Research Unit, Glasgow Caledonian University, Glasgow G4 0BA, UK.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Sergenson', 'Affiliation': 'Nursing, Midwifery and Allied Health Professions Research Unit, Glasgow Caledonian University, Glasgow G4 0BA, UK.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Bugge', 'Affiliation': 'Faculty of Health Sciences and Sport, University of Stirling, Stirling, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Dean', 'Affiliation': 'College of Medicine and Health, University of Exeter Medical School, Exeter, UK.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Hay-Smith', 'Affiliation': 'Rehabilitation Teaching and Research Unit, University of Otago, Wellington, New Zealand.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Kilonzo', 'Affiliation': 'Health Economics Research Unit, University of Aberdeen, Foresterhill, Aberdeen, UK.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Dimitrova', 'Affiliation': 'Health Economics Research Unit, University of Aberdeen, Foresterhill, Aberdeen, UK.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Abdel-Fattah', 'Affiliation': ""Aberdeen Centre for Women's Health Research, University of Aberdeen, Foresterhill, Aberdeen, UK.""}, {'ForeName': 'Wael', 'Initials': 'W', 'LastName': 'Agur', 'Affiliation': 'Crosshouse Hospital, NHS Ayrshire and Arran, Crosshouse, Kilmarnock, UK.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Booth', 'Affiliation': 'School of Health and Life Sciences, Glasgow Caledonian University, Glasgow, UK.'}, {'ForeName': 'Cathryn', 'Initials': 'C', 'LastName': 'Glazener', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Foresterhill, Aberdeen, UK.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Guerrero', 'Affiliation': 'Queen Elizabeth University Hospital, NHS Greater Glasgow and Clyde, Glasgow, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'McDonald', 'Affiliation': 'Centre for Healthcare Randomised Trials (CHaRT), Health Services Research Unit, University of Aberdeen, Foresterhill, Aberdeen, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Norrie', 'Affiliation': 'Edinburgh Clinical Trials Unit, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Louise R', 'Initials': 'LR', 'LastName': 'Williams', 'Affiliation': 'Nursing, Midwifery and Allied Health Professions Research Unit, Glasgow Caledonian University, Glasgow G4 0BA, UK.'}, {'ForeName': 'Doreen', 'Initials': 'D', 'LastName': 'McClurg', 'Affiliation': 'Nursing, Midwifery and Allied Health Professions Research Unit, Glasgow Caledonian University, Glasgow G4 0BA, UK.'}]",BMJ (Clinical research ed.),['10.1136/bmj.m3719']
3461,33057367,Higher iron stores and the HFE 187C>G variant delay onset of peripheral neuropathy during combination antiretroviral therapy.,"OBJECTIVE


People with HIV (PWH) continue to experience sensory neuropathy and neuropathic pain in the combination antiretroviral therapy (cART) era for unclear reasons. This study evaluated the role of iron in a previously reported association of iron-loading hemochromatosis (HFE) gene variants with reduced risk of neuropathy in PWH who received more neurotoxic cART, since an iron-related mechanism also might be relevant to neuropathic symptoms in PWH living in low-resource settings today.
DESIGN


This time-to-event analysis addressed the impact of systemic iron levels on the rapidity of neuropathy onset in PWH who initiated cART.
METHODS


Soluble transferrin receptor (sTFR), the sTFR-ferritin index of iron stores, and high-sensitivity C-reactive protein (hsCRP) levels were determined in stored baseline sera from participants of known HFE genotype from AIDS Clinical Trials Group (ACTG) Study 384, a multicenter randomized clinical trial that evaluated cART strategies. Associations with incident neuropathy were evaluated in proportional-hazards, time-to-event regression models, adjusting for potential confounders.
RESULTS


Of 151 eligible participants with stored serum who were included in the original genetic study, 43 had cART-associated neuropathy; 108 had sufficient serum for analysis, including 30 neuropathy cases. Carriers of HFE variants had higher systemic iron (lower sTFR and sTFR-ferritin index) and lower hsCRP levels than non-carriers (all p<0.05). Higher sTFR or iron stores, the HFE 187C>G variant, and lower baseline hsCRP were associated with significantly delayed neuropathy in self-reported whites (n = 28; all p-values<0.05), independent of age, CD4+ T-cell count, plasma HIV RNA, and cART regimen.
CONCLUSIONS


Higher iron stores, the HFE 187C>G variant, and lower hsCRP predicted delayed onset of neuropathy among self-reported white individuals initating cART. These findings require confirmation but may have implications for cART in HIV+ populations in areas with high endemic iron deficiency, especially those PWH in whom older, more neurotoxic antiretroviral drugs are occasionally still used.",2020,Carriers of HFE variants had higher systemic iron (lower sTFR and sTFR-ferritin index) and lower hsCRP levels than non-carriers (all p<0.05).,"['151 eligible participants with stored serum who were included in the original genetic study', 'People with HIV (PWH']",[],"['Higher sTFR or iron stores', 'systemic iron (lower sTFR and sTFR-ferritin index) and lower hsCRP levels', 'sTFR-ferritin index of iron stores, and high-sensitivity C-reactive protein (hsCRP) levels']","[{'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0017296', 'cui_str': 'Gene therapy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}]",[],"[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1116139', 'cui_str': 'Transferrin receptor, soluble'}, {'cui': 'C0450235', 'cui_str': 'Evaluation of iron stores'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0015879', 'cui_str': 'Ferritin'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",151.0,0.107466,Carriers of HFE variants had higher systemic iron (lower sTFR and sTFR-ferritin index) and lower hsCRP levels than non-carriers (all p<0.05).,"[{'ForeName': 'Asha R', 'Initials': 'AR', 'LastName': 'Kallianpur', 'Affiliation': 'Genomic Medicine Institute, Cleveland Clinic/Lerner Research Institute, Cleveland, Ohio, United States of America.'}, {'ForeName': 'Wanqing', 'Initials': 'W', 'LastName': 'Wen', 'Affiliation': 'Division of Epidemiology, Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, United States of America.'}, {'ForeName': 'Angelika L', 'Initials': 'AL', 'LastName': 'Erwin', 'Affiliation': 'Genomic Medicine Institute, Cleveland Clinic/Lerner Research Institute, Cleveland, Ohio, United States of America.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Clifford', 'Affiliation': 'Division of Infectious Diseases, Departments of Medicine and Neurology, Washington University School of Medicine, Saint Louis, Missouri, United States of America.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Hulgan', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, United States of America.'}, {'ForeName': 'Gregory K', 'Initials': 'GK', 'LastName': 'Robbins', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts, United States of America.'}]",PloS one,['10.1371/journal.pone.0239758']
3462,33057642,Association of Prehospital Plasma With Survival in Patients With Traumatic Brain Injury: A Secondary Analysis of the PAMPer Cluster Randomized Clinical Trial.,"Importance


Prehospital plasma administration improves survival in injured patients at risk for hemorrhagic shock and transported by air ambulance. Traumatic brain injury (TBI) is a leading cause of death following trauma, but few early interventions improve outcomes.
Objective


To assess the association between prehospital plasma and survival in patients with TBI.
Design, Setting, and Participants


The Prehospital Air Medical Plasma (PAMPer) trial was a pragmatic, multicenter, phase 3, cluster randomized clinical trial involving injured patients who were at risk for hemorrhagic shock during air medical transport to a trauma center. The trial was conducted at 6 US sites with 9 level-I trauma centers (comprising 27 helicopter emergency services bases). The original trial analyzed 501 patients, including 230 patients who were randomized to receive plasma and 271 randomized to standard care resuscitation. This secondary analysis of a predefined subgroup included patients with TBI. Data analysis was performed from October 2019 to February 2020.
Interventions


Patients were randomized to receive standard care fluid resuscitation or 2 units of thawed plasma.
Main Outcomes and Measures


The primary outcome was mortality at 30 days. Patients with TBI were prespecified as a subgroup for secondary analysis and for measurement of markers of brain injury. The 30-day survival benefit of prehospital plasma in subgroups with and without TBI as diagnosed by computed tomography was characterized using Kaplan-Meier survival analysis and Cox proportional hazard regression.
Results


In total, 166 patients had TBI (median [interquartile range] age, 43.00 [25.00-59.75] years; 125 men [75.3%]). When compared with the 92 patients who received standard care, the 74 patients with TBI who received prehospital plasma had improved 30-day survival even after adjustment for multiple confounders and assessment of the degree of brain injury with clinical variables and biomarkers (hazard ratio [HR], 0.55; 95% CI, 0.33-0.94; P = .03). Receipt of prehospital plasma was associated with improved survival among patients with TBI with a prehospital Glasgow Coma Scale score of less than 8 (HR, 0.56; 95% CI, 0.35-0.91) and those with polytrauma (HR, 0.50; 95% CI, 0.28-0.89). Patients with TBI transported from the scene of injury had improved survival following prehospital plasma administration (HR, 0.45; 95% CI, 0.26-0.80; P = .005), whereas patients who were transferred from an outside hospital showed no difference in survival for the plasma intervention (HR, 1.00; 95% CI, 0.33-3.00; P = .99).
Conclusions and Relevance


These findings are exploratory, but they suggest that receipt of prehospital plasma is associated with improved survival in patients with computed tomography-positive TBI. The prehospital setting may be a critical period to intervene in the care of patients with TBI. Future studies are needed to confirm the clinical benefits of early plasma resuscitation following TBI and concomitant polytrauma.
Trial Registration


ClinicalTrials.gov Identifier: NCT01818427.",2020,"Patients with TBI transported from the scene of injury had improved survival following prehospital plasma administration (HR, 0.45; 95% CI, 0.26-0.80; P = .005), whereas patients who were transferred from an outside hospital showed no difference in survival for the plasma intervention (HR, 1.00; 95% CI, 0.33-3.00; P = .99).
","['patients with TBI', 'injured patients who were at risk for hemorrhagic shock during air medical transport to a trauma center', 'injured patients at risk for hemorrhagic shock and transported by air ambulance', 'Patients With Traumatic Brain Injury', '501 patients, including 230 patients who were randomized to receive plasma and 271 randomized to standard care resuscitation', '6 US sites with 9 level-I trauma centers (comprising 27 helicopter emergency services bases', '25.00-59.75] years; 125 men [75.3', 'patients with computed tomography-positive TBI', '166 patients had TBI (median [interquartile range] age, 43.00', 'Traumatic brain injury (TBI']",['standard care fluid resuscitation or 2 units of thawed plasma'],"['prehospital Glasgow Coma Scale score', 'mortality at 30 days', '30-day survival benefit of prehospital plasma', '30-day survival', 'survival following prehospital plasma administration', 'prehospital plasma and survival', 'survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0036982', 'cui_str': 'Hemorrhagic shock'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0005528', 'cui_str': 'Biological transport'}, {'cui': 'C0040786', 'cui_str': 'Trauma center'}, {'cui': 'C0206185', 'cui_str': 'Air transport ambulance'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0441925', 'cui_str': 'Level I'}, {'cui': 'C0206183', 'cui_str': 'Emergency Helicopters'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C5191361', 'cui_str': '166'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}]","[{'cui': 'C0017594', 'cui_str': 'Glasgow coma scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]",501.0,0.386256,"Patients with TBI transported from the scene of injury had improved survival following prehospital plasma administration (HR, 0.45; 95% CI, 0.26-0.80; P = .005), whereas patients who were transferred from an outside hospital showed no difference in survival for the plasma intervention (HR, 1.00; 95% CI, 0.33-3.00; P = .99).
","[{'ForeName': 'Danielle S', 'Initials': 'DS', 'LastName': 'Gruen', 'Affiliation': 'Department of Surgery and Critical Care Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Francis X', 'Initials': 'FX', 'LastName': 'Guyette', 'Affiliation': 'Department of Emergency Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Joshua B', 'Initials': 'JB', 'LastName': 'Brown', 'Affiliation': 'Department of Surgery and Critical Care Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'David O', 'Initials': 'DO', 'LastName': 'Okonkwo', 'Affiliation': 'Department of Neurological Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Ava M', 'Initials': 'AM', 'LastName': 'Puccio', 'Affiliation': 'Department of Neurological Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Insiyah K', 'Initials': 'IK', 'LastName': 'Campwala', 'Affiliation': 'Department of Surgery and Critical Care Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Tessmer', 'Affiliation': 'Department of Surgery and Critical Care Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Daley', 'Affiliation': 'Department of Surgery, University of Tennessee Health Science Center, Knoxville.'}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Miller', 'Affiliation': 'Department of Surgery, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Brian G', 'Initials': 'BG', 'LastName': 'Harbrecht', 'Affiliation': 'Department of Surgery, University of Louisville, Louisville, Kentucky.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Claridge', 'Affiliation': 'MetroHealth Medical Center, Case Western Reserve University, Cleveland, Ohio.'}, {'ForeName': 'Herb A', 'Initials': 'HA', 'LastName': 'Phelan', 'Affiliation': 'Department of Surgery, University of Texas Southwestern, Dallas.'}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Neal', 'Affiliation': 'Department of Surgery and Critical Care Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Brian S', 'Initials': 'BS', 'LastName': 'Zuckerbraun', 'Affiliation': 'Department of Surgery and Critical Care Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Mark H', 'Initials': 'MH', 'LastName': 'Yazer', 'Affiliation': 'Department of Pathology, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Timothy R', 'Initials': 'TR', 'LastName': 'Billiar', 'Affiliation': 'Department of Surgery and Critical Care Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Jason L', 'Initials': 'JL', 'LastName': 'Sperry', 'Affiliation': 'Department of Surgery and Critical Care Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.16869']
3463,33057643,Virtual Standardized Patients vs Academic Training for Learning Motivational Interviewing Skills in the US Department of Veterans Affairs and the US Military: A Randomized Trial.,"Importance


Despite the need for effective and scalable training in motivational interviewing (MI) that includes posttraining coaching and feedback, limited evidence exists regarding the effectiveness of using virtual (computerized) standardized patients (VSPs) in such training.
Objective


To evaluate the efficacy of training with a VSP on the acquisition and maintenance of MI skills compared with traditional academic study.
Design, Setting, and Participants


This study was a 2-group, parallel-training randomized trial of 120 volunteer health care professionals recruited from a Department of Veterans Affairs and Department of Defense medical facility. Motivational interviewing skill was coded by external experts blinded to training group and skill assessment time points. Data were collected from October 17, 2016, to August 12, 2019.
Interventions


After a computer course on MI, participants trained during two 45-minute sessions separated by 3 months. The 2 randomized training conditions included a branching storyline VSP, which provided MI skill rehearsal with immediate and summative feedback, and a control condition, which included academic study of content from the computerized MI course.
Main Outcomes and Measures


Measurement of MI skill was based on recorded conversations with human standardized patients, assessed using the Motivational Interviewing Treatment Integrity 4.2.1 coding system, measured at baseline, after training, and after additional training in the randomized condition 3 months later.
Results


A total of 120 volunteers (83 [69%] women), with a mean (SD) of 13.6 (10.3) years of health care experience, participated in the study; 61 were randomized to receive the intervention, and 59 were randomized to the control group. Those assigned to VSP training had significantly greater posttraining improvement in technical global scores (0.23; 95% CI, 0.03-0.44; P = .02), relational global scores (0.57; 95% CI, 0.33-0.81; P = .001), and the reflection-to-question ratio (0.23; 95% CI, 0.15-0.31; P = .001). Differences were maintained after the 3-month additional training session, with more improvements achieved after the 3-month training for the VSP trainees on the reflection-to- question ratio (0.15; 95% CI, 0.07-0.24; P = .001).
Conclusions and Relevance


This randomized trial demonstrated a successful transfer of training from a VSP to human standardized patients. The VSP MI skill outcomes were better than those achieved with academic study and were maintained over time. Virtual standardized patients have the potential to facilitate dissemination of MI and may be useful for training in other evidence-based skills and treatments.
Trial Registration


ClinicalTrials.gov Identifier: NCT04558060.",2020,"Those assigned to VSP training had significantly greater posttraining improvement in technical global scores (0.23; 95% CI, 0.03-0.44; P = .02), relational global scores (0.57; 95% CI, 0.33-0.81; P = .001), and the reflection-to-question ratio (0.23; 95% CI, 0.15-0.31; P = .001).","['120 volunteer health care professionals recruited from a Department of Veterans Affairs and Department of Defense medical facility', 'Data were collected from October 17, 2016, to August 12, 2019', '120 volunteers (83 [69%] women), with a mean (SD) of 13.6 (10.3) years of health care experience, participated in the study; 61', 'Veterans Affairs and the US Military', 'human standardized patients']","['VSP', 'VSP training', 'Virtual Standardized Patients vs Academic Training', 'branching storyline VSP, which provided MI skill rehearsal with immediate and summative feedback, and a control condition']","['Measures\n\n\nMeasurement of MI skill', 'relational global scores', 'reflection-to-question ratio', 'technical global scores', 'VSP MI skill outcomes', 'reflection-to- question ratio']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517560', 'cui_str': '13.6'}, {'cui': 'C4517519', 'cui_str': '10.3'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0000875', 'cui_str': 'Academic Training'}, {'cui': 'C0205384', 'cui_str': 'Branching'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",120.0,0.0642577,"Those assigned to VSP training had significantly greater posttraining improvement in technical global scores (0.23; 95% CI, 0.03-0.44; P = .02), relational global scores (0.57; 95% CI, 0.33-0.81; P = .001), and the reflection-to-question ratio (0.23; 95% CI, 0.15-0.31; P = .001).","[{'ForeName': 'Greg M', 'Initials': 'GM', 'LastName': 'Reger', 'Affiliation': 'Veterans Affairs (VA) Puget Sound Healthcare System, Seattle and Tacoma, Washington.'}, {'ForeName': 'Aaron M', 'Initials': 'AM', 'LastName': 'Norr', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, Seattle.'}, {'ForeName': 'Albert Skip', 'Initials': 'AS', 'LastName': 'Rizzo', 'Affiliation': 'Institute for Creative Technologies, University of Southern California, Marina del Rey.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Sylvers', 'Affiliation': 'Veterans Affairs (VA) Puget Sound Healthcare System, Seattle and Tacoma, Washington.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Peltan', 'Affiliation': 'Veterans Affairs (VA) Puget Sound Healthcare System, Seattle and Tacoma, Washington.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Fischer', 'Affiliation': 'Veterans Affairs (VA) Puget Sound Healthcare System, Seattle and Tacoma, Washington.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Trimmer', 'Affiliation': 'Institute for Creative Technologies, University of Southern California, Marina del Rey.'}, {'ForeName': 'Shelan', 'Initials': 'S', 'LastName': 'Porter', 'Affiliation': 'Veterans Affairs (VA) Puget Sound Healthcare System, Seattle and Tacoma, Washington.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Gant', 'Affiliation': 'Veterans Affairs (VA) Puget Sound Healthcare System, Seattle and Tacoma, Washington.'}, {'ForeName': 'John S', 'Initials': 'JS', 'LastName': 'Baer', 'Affiliation': 'Veterans Affairs (VA) Puget Sound Healthcare System, Seattle and Tacoma, Washington.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.17348']
3464,33059650,Impact of pulmonary rehabilitation on patients' health care needs and asthma control: a quasi-experimental study.,"BACKGROUND


Pulmonary rehabilitation offers potential benefits to people with asthma. It is however unknown if rehabilitation favourably affects patients' health care needs. We therefore examined if rehabilitation reduced needs and, in addition, if it improved asthma control.
METHODS


One hundred fifty patients with asthma were surveyed in three rehabilitation clinics at admission and at discharge. Additionally, we surveyed 78 participants with asthma twice 4 weeks apart. The latter sample (i.e. the control group) was recruited through other pathways than rehabilitation clinics. The Patient Needs in Asthma Treatment (NEAT) questionnaire and the Asthma Control Test (ACT) were completed at baseline and follow-up. Differences between baseline and follow-up and between rehabilitation and control group were examined by t-tests and chi-squared-tests. Univariate ANCOVAS were used to examine if NEAT and ACT follow-up scores differed significantly between groups. Within the rehabilitation group, linear regressions were used to examine if self-reported utilization of more interventions that addressed needs were associated with NEAT scores at follow-up.
RESULTS


At baseline, there were no differences between the rehabilitation and the control group regarding needs and asthma control. At follow-up, the rehabilitation group showed reduced needs (t(149) = 10.33, p <  0.01) and increased asthma control (t(130) = -6.67, p <  0.01), whereas members of the control group exhibited no changes. Univariate ANCOVAS showed that unmet follow-up needs (F(1, 212) = 36.46, p <  0.001) and follow-up asthma control (F(1, 195) = 6.97, p = 0.009) differed significantly between groups. In the rehabilitation group, self-reported utilization of more interventions was associated with reduced needs (β = 0.21; p = 0.03).
CONCLUSIONS


This study provides preliminary evidence suggestion that pulmonary rehabilitation in adults with asthma may reduce asthma-related needs and confirms previous findings that rehabilitation may improve asthma control.",2020,"In the rehabilitation group, self-reported utilization of more interventions was associated with reduced needs (β = 0.21; p = 0.03).
","['78 participants with asthma twice 4 weeks apart', 'people with asthma', 'adults with asthma', 'One hundred fifty patients with asthma were surveyed in three rehabilitation clinics at admission and at discharge', ""patients' health care needs and asthma control""]",['pulmonary rehabilitation'],[],"[{'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C3839785', 'cui_str': 'Rehabilitation clinic'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C3871203', 'cui_str': 'At discharge'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}]",[],78.0,0.035197,"In the rehabilitation group, self-reported utilization of more interventions was associated with reduced needs (β = 0.21; p = 0.03).
","[{'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Salandi', 'Affiliation': 'Institute of Occupational, Social, and Environmental Medicine, Centre for Health and Society, Medical Faculty, University of Düsseldorf, Moorenstraße 5, 40225, Düsseldorf, Germany. julia.schreitmueller@uni-duesseldorf.de.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Icks', 'Affiliation': 'Institute of Health Services Research and Health Economics, Centre for Health and Society, Medical Faculty, University of Düsseldorf, Moorenstraße 5, 40225, Düsseldorf, Germany.'}, {'ForeName': 'Jalal', 'Initials': 'J', 'LastName': 'Gholami', 'Affiliation': 'Nordseeklinik Borkum der DRV Rheinland, Bubertstraße 4, 26757, Borkum, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Hummel', 'Affiliation': 'MEDIAN Klinik Heiligendamm, Kinderstrand 1, 18209, Bad Doberan, Germany.'}, {'ForeName': 'Konrad', 'Initials': 'K', 'LastName': 'Schultz', 'Affiliation': 'Klinik Bad Reichenhall der DRV Bayern Süd, Salzburger Str. 8-11, 83435, Bad Reichenhall, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Apfelbacher', 'Affiliation': 'Institute of Social Medicine and Health Systems Research (ISMHSR), Otto von Guericke University Magdeburg, Leipziger Str. 44, 39120, Magdeburg, Germany.'}, {'ForeName': 'Aziz', 'Initials': 'A', 'LastName': 'Sheikh', 'Affiliation': 'Usher Institute, University of Edinburgh, Old Medical School, Teviot Place, Edinburgh, EH8 9AG, UK.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Loerbroks', 'Affiliation': 'Institute of Occupational, Social, and Environmental Medicine, Centre for Health and Society, Medical Faculty, University of Düsseldorf, Moorenstraße 5, 40225, Düsseldorf, Germany.'}]",BMC pulmonary medicine,['10.1186/s12890-020-01301-9']
3465,33059669,"Long-lasting insecticide-treated bed net ownership, utilization and associated factors among school-age children in Dara Mallo and Uba Debretsehay districts, Southern Ethiopia.","BACKGROUND


Malaria is one of the major causes of morbidity and mortality among school-age children (SAC) in sub-Saharan Africa. SAC account for more than 60% of the reservoir of malaria transmission, but they are given less emphasis in prioritizing malaria prevention interventions. This study was aimed at assessing the ownership of long-lasting insecticide treated bed nets (LLINs), its utilization and factors associated with ownership of LLINs by households and LLINs utilization among SAC in malaria-prone areas of Dara Mallo and Uba Debretsehay districts in Southern Ethiopia, October to December 2019.
METHODS


This study is part of a baseline assessment in a cluster-randomized controlled trial. The data was collected through interview and observation, following a structured questionnaire, of 2261 SAC households. Univariable and multivariable multilevel logistic regressions were used to assess the association between LLINs ownership and utilization and potential predictor variables. Odds ratio (OR) and corresponding 95% confidence interval (CI) were used to determine the strength and statistical significance of association.
RESULTS


The ownership of at least one LLIN by households of SAC was about 19.3% (95% CI 17.7-21.0%) but only 10.3% % (95% CI 7.7-13.7%) of these households had adequate access of bed nets to the household members. Ownership of bed net was marginally affected by living in semi-urban area (adjusted OR = 2.6; 95% CI 1.0-6.9) and occupational status of the household head being a civil servant (adjusted OR = 2.7; 95% CI 0.9-7.9). About 7.8% (95% CI 6.7-10.0%) of all SAC participated in the study and 40.4% (95% CI 57.4-66.7%) of children in households owning at least one LLIN passed the previous night under LLIN. LLIN utilization by SAC conditional to presence of at least one net in the household was significantly correlated with education level of mother above grade 6 (adjusted OR = 3.4; 95% CI 1.3-9.3) and the household size to bed net ratio less than or equal to 2 (adjusted OR = 20.7; 95% CI 4.7-132.5).
CONCLUSION


Ownership of bed net was lower than universal coverage of at least one bed net for two individuals. It is important to monitor replacement needs and educate mothers with low education level with their SAC on the benefit of consistent utilization of bed nets.",2020,Ownership of bed net was marginally affected by living in semi-urban area (adjusted OR = 2.6; 95% CI 1.0-6.9) and occupational status of the household head being a civil servant (adjusted OR = 2.7; 95% CI 0.9-7.9).,"['2261 SAC households', 'school-age children (SAC) in sub-Saharan Africa', 'malaria-prone areas of Dara Mallo and Uba Debretsehay districts in Southern Ethiopia, October to December 2019', 'school-age children in Dara Mallo and Uba Debretsehay districts, Southern Ethiopia']",['ownership of long-lasting insecticide treated bed nets (LLINs'],"['Odds ratio (OR', 'Ownership of bed net', 'LLIN utilization']","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0001738', 'cui_str': 'Sub-Saharan Africa'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0033422', 'cui_str': 'Prone body position'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0015024', 'cui_str': 'Ethiopia'}]","[{'cui': 'C0029981', 'cui_str': 'Ownership'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C2717999', 'cui_str': 'Insecticide-Treated Bed Nets'}]","[{'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0029981', 'cui_str': 'Ownership'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",2261.0,0.115165,Ownership of bed net was marginally affected by living in semi-urban area (adjusted OR = 2.6; 95% CI 1.0-6.9) and occupational status of the household head being a civil servant (adjusted OR = 2.7; 95% CI 0.9-7.9).,"[{'ForeName': 'Zerihun', 'Initials': 'Z', 'LastName': 'Zerdo', 'Affiliation': 'Department of Medical Laboratory Science, College of Medicine and Health Sciences, Arba Minch University, Arba Minch, Ethiopia. zedozerihun@gmail.com.'}, {'ForeName': 'Hilde', 'Initials': 'H', 'LastName': 'Bastiaens', 'Affiliation': 'Department of Family Medicine and Population Health, Antwerp University, Antwerp, Belgium.'}, {'ForeName': 'Sibyl', 'Initials': 'S', 'LastName': 'Anthierens', 'Affiliation': 'Department of Family Medicine and Population Health, Antwerp University, Antwerp, Belgium.'}, {'ForeName': 'Fekadu', 'Initials': 'F', 'LastName': 'Massebo', 'Affiliation': 'Department of Biology, College of Natural Sciences, Arba Minch University, Arba Minch, Ethiopia.'}, {'ForeName': 'Matewos', 'Initials': 'M', 'LastName': 'Masne', 'Affiliation': 'Department of Biology, College of Natural Sciences, Arba Minch University, Arba Minch, Ethiopia.'}, {'ForeName': 'Gelila', 'Initials': 'G', 'LastName': 'Biresaw', 'Affiliation': 'Department of Medical Laboratory Science, College of Medicine and Health Sciences, Arba Minch University, Arba Minch, Ethiopia.'}, {'ForeName': 'Misgun', 'Initials': 'M', 'LastName': 'Shewangizaw', 'Affiliation': 'Department of Public Health, College of Medicine and Health Sciences, Arba Minch University, Arba Minch, Ethiopia.'}, {'ForeName': 'Abayneh', 'Initials': 'A', 'LastName': 'Tunje', 'Affiliation': 'Department of Public Health, College of Medicine and Health Sciences, Arba Minch University, Arba Minch, Ethiopia.'}, {'ForeName': 'Yilma', 'Initials': 'Y', 'LastName': 'Chisha', 'Affiliation': 'Department of Public Health, College of Medicine and Health Sciences, Arba Minch University, Arba Minch, Ethiopia.'}, {'ForeName': 'Tsegaye', 'Initials': 'T', 'LastName': 'Yohannes', 'Affiliation': 'Department of Medical Laboratory Science, College of Medicine and Health Sciences, Arba Minch University, Arba Minch, Ethiopia.'}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Van Geertruyden', 'Affiliation': 'Global Health Institute, Antwerp University, Antwerp, Belgium.'}]",Malaria journal,['10.1186/s12936-020-03437-9']
3466,33059679,Effect of a high value care curriculum on standardized patient exam in the Core Clerkship in Internal Medicine.,"BACKGROUND


With almost 20% unnecessary spending on healthcare, there has been increasing interest in high value care defined as the best care for the patient, with the optimal result for the circumstances, delivered at the right price. The American Association of Medical Colleges recommend that medical students are proficient in concepts of cost-effective clinical practice by graduation, thus leading to curricula on high value care. However little is published on the effectiveness of these curricula on medical students' ability to practice high value care.
METHODS


In addition to the standard curriculum, the intervention group received two classroom sessions and three virtual patients focused on the concepts of high value care. The primary outcome was number of tests and charges for tests on standardized patients.
RESULTS


136 students enrolled in the Core Clerkship in Internal Medicine and 70 completed the high value care curriculum. There were no significant differences in ordering of appropriate tests (3.1 vs. 3.2 tests/students, p = 0.55) and inappropriate tests (1.8 vs. 2.2, p = 0.13) between the intervention and control. Students in the intervention group had significantly lower median Medicare charges ($287.59 vs. $500.86, p = 0.04) and felt their education in high value care was appropriate (81% vs. 56%, p = 0.02).
CONCLUSIONS


This is the first study to describe the impact of a high value care curriculum on medical students' ordering practices. While number of inappropriate tests was not significantly different, students in the intervention group refrained from ordering expensive tests.",2020,"Students in the intervention group had significantly lower median Medicare charges ($287.59 vs. $500.86, p = 0.04) and felt their education in high value care was appropriate (81% vs. 56%, p = 0.02).
","['136 students enrolled in the Core Clerkship in Internal Medicine and 70 completed the high value care curriculum', ""medical students' ordering practices"", 'standardized patient exam in the Core Clerkship in Internal Medicine']",['high value care curriculum'],"['ordering of appropriate tests', 'inappropriate tests', 'number of tests and charges for tests on standardized patients', 'median Medicare charges']","[{'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0021782', 'cui_str': 'Internal medicine'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0582103', 'cui_str': 'Medical assessment'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}]","[{'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C3542467', 'cui_str': 'Inappropriate'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0007961', 'cui_str': 'Charges'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0018717', 'cui_str': 'Health Insurance for Aged and Disabled, Title 18'}]",136.0,0.0265975,"Students in the intervention group had significantly lower median Medicare charges ($287.59 vs. $500.86, p = 0.04) and felt their education in high value care was appropriate (81% vs. 56%, p = 0.02).
","[{'ForeName': 'Amit K', 'Initials': 'AK', 'LastName': 'Pahwa', 'Affiliation': 'Division of Hospital Medicine, Division of General Pediatrics, Johns Hopkins University School of Medicine, 600 North Wolfe Street, Baltimore, MD, 21287, USA. pahwa@jhu.edu.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Eaton', 'Affiliation': 'Divsion of General Internal Medicine, Department of Medicine, Johns Hopkins University School of Medicine, 600 North Wolfe Street, Harvey 806, Baltimore, MD, 21287, USA.'}, {'ForeName': 'Ariella', 'Initials': 'A', 'LastName': 'Apfel', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Johns Hopkins University School of Medicine, 2024 East Monument Street, Baltimore, MD, 21287, USA.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Bertram', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Johns Hopkins University School of Medicine, 601 North Caroline Street, Baltimore, MD, 21287, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Ridell', 'Affiliation': 'Office of Assessment and Evaluation, Johns Hopkins University School of Medicine, 2024 East Monument Street, Room 1-200, Baltimore, MD, 21287, USA.'}, {'ForeName': 'Danelle', 'Initials': 'D', 'LastName': 'Cayea', 'Affiliation': 'Division of Geriatrics, Department of Medicine, Johns Hopkins University School of Medicine, 5200 Easter Avenue, Mason Lord Building Center Tower Suite, Baltimore, MD, 2200, USA.'}]",BMC medical education,['10.1186/s12909-020-02303-1']
3467,33059710,"Associations between Patient Global Assessment scores and pain, physical function, and fatigue in rheumatoid arthritis: a post hoc analysis of data from phase 3 trials of tofacitinib.","BACKGROUND


Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). We examined the degree to which Patient Global Assessment of Disease Activity (PtGA) was driven by patient-reported assessments of pain (Pain), physical function, and fatigue in patients receiving tofacitinib 5 mg twice daily or placebo, each with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs).
METHODS


This post hoc analysis used data pooled from three randomized controlled trials in csDMARD-inadequate responder (csDMARD-IR) patients (ORAL Scan: NCT00847613; ORAL Standard: NCT00853385; ORAL Sync: NCT00856544). Using subgroup analysis from 2 × 2 tables, associations between PtGA and Pain, Health Assessment Questionnaire-Disability Index (HAQ-DI), and Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) at month 3 were evaluated using Pearson's Phi correlation coefficients. To support the main analysis, associations between select patient-reported outcomes (PROs) were also evaluated in csDMARD-naïve (ORAL Start; NCT01039688) and biologic (b)DMARD-IR (ORAL Step; NCT00960440) patients.
RESULTS


Across csDMARD-IR treatment groups, low disease activity (defined as PtGA ≤ 20 mm), and moderate (≥ 30%) and substantial (≥ 50%) improvements from baseline in PtGA were associated with mild Pain (Visual Analog Scale score ≤ 20 mm), and moderate (≥ 30%) and substantial (≥ 50%) improvements from baseline in Pain; lack of Pain improvement was associated with little/no improvement in PtGA. In contrast, large proportions of csDMARD-IR patients who reported PtGA improvements did not report HAQ-DI or FACIT-F scores ≥ normative values (≤ 0.25 and ≥ 43.5, respectively) or changes in HAQ-DI or FACIT-F scores ≥ minimum clinically important difference (≥ 0.22 and ≥ 4.0, respectively). Generally, PtGA and Pain outcomes were moderately-to-strongly correlated at month 3 in csDMARD-IR patients, with weaker correlations evident between PtGA and HAQ-DI/FACIT-F outcomes. Similar findings were generally evident in csDMARD-naïve and bDMARD-IR patients.
CONCLUSIONS


This analysis supports the role of Pain as a key driver of PtGA in RA; physical function and fatigue play lesser roles in patients' perceptions of disease activity. These findings corroborate the importance of improved PROs and attainment of low symptom states for optimizing patient care.
TRIAL REGISTRATION


Clinicaltrials.gov: NCT00847613 (registered: February 19, 2009); NCT00853385 (registered: March 2, 2009); NCT00856544 (registered: March 5, 2009); NCT01039688 (registered: December 25, 2009); NCT00960440 (registered: August 17, 2009).",2020,"Generally, PtGA and Pain outcomes were moderately-to-strongly correlated at month 3 in csDMARD-IR patients, with weaker correlations evident between PtGA and HAQ-DI/FACIT-F outcomes.",[],"['tofacitinib', 'tofacitinib 5\u2009mg twice daily or placebo, each with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs']","['pain, physical function, and fatigue in rheumatoid arthritis', 'mild Pain (Visual Analog Scale score', 'PtGA and Pain outcomes', 'HAQ-DI or FACIT-F scores', 'low disease activity', 'PtGA', 'Pain; lack of Pain improvement', 'pain (Pain), physical function, and fatigue', 'PtGA and Pain, Health Assessment Questionnaire-Disability Index (HAQ-DI), and Functional Assessment of Chronic Illness Therapy-Fatigue', 'HAQ-DI or FACIT-F scores ≥\u2009normative values']",[],"[{'cui': 'C2930696', 'cui_str': 'tofacitinib'}, {'cui': 'C3505040', 'cui_str': 'tofacitinib 5 MG'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0242708', 'cui_str': 'Disease-Modifying Antirheumatic Drugs'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0278138', 'cui_str': 'Mild pain'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0451208', 'cui_str': 'Health assessment questionnaire'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0332268', 'cui_str': 'Lacking'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.143685,"Generally, PtGA and Pain outcomes were moderately-to-strongly correlated at month 3 in csDMARD-IR patients, with weaker correlations evident between PtGA and HAQ-DI/FACIT-F outcomes.","[{'ForeName': 'Vibeke', 'Initials': 'V', 'LastName': 'Strand', 'Affiliation': 'Division of Immunology/Rheumatology, Stanford University, Palo Alto, CA, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Kaine', 'Affiliation': 'Independent Healthcare Associates Inc, Cullowhee, NC, USA.'}, {'ForeName': 'Rieke', 'Initials': 'R', 'LastName': 'Alten', 'Affiliation': 'Schlosspark-Klinik, University Medicine, Berlin, Germany.'}, {'ForeName': 'Gene', 'Initials': 'G', 'LastName': 'Wallenstein', 'Affiliation': 'Pfizer Inc, Groton, CT, USA.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Diehl', 'Affiliation': 'Pfizer Inc, Collegeville, PA, USA.'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Shi', 'Affiliation': 'Pfizer Inc, Collegeville, PA, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Germino', 'Affiliation': 'Pfizer Inc, New York, NY, USA.'}, {'ForeName': 'Christopher W', 'Initials': 'CW', 'LastName': 'Murray', 'Affiliation': 'Pfizer Inc, Collegeville, PA, USA. Christopher.W.Murray@pfizer.com.'}]",Arthritis research & therapy,['10.1186/s13075-020-02324-7']
3468,33059763,Does a video clip enhance recruitment into a parenting trial? Learnings from a study within a trial.,"BACKGROUND


Reaching recruitment targets in randomised controlled trials is a challenge. Media tools are increasingly used to engage participants, yet there is a paucity of research into the use of video to optimise recruitment. We therefore tested whether adding a participant information video clip to a standard participant information sheet improved recruitment into a parenting trial.
METHODS


One hundred seven participants were randomised to receive either a participant information sheet (n = 51) or an informational video clip (n = 56) as part of an email contact following a screening phase. All participants went on to receive the information sheet as part of the existing consent procedure.
RESULTS


The video condition did not increase the odds of recruitment into the trial, such that those in the video condition were significantly less likely to participate in the main trial (OR = 0.253, CI = 0.104-0.618, p = 0.003).
CONCLUSION


The introduction of a video clip into the recruitment stages of a parenting trial did not lead to an improvement in recruitment; however, the small sample size precludes definitive inferences. We offer reflections on challenges encountered in implementing the SWAT and suggestions for other researchers seeking to embed recruitment SWATs into similar trials.
TRIAL REGISTRATION


Current controlled trials ISRCTN 58327365 . Registered on 19 March 2015.
SWAT REGISTRATION


SWAT 106; Effects of a video clip on recruitment into a randomised trial. Registered on 20 December 2016.",2020,One hundred seven participants were randomised to receive either a participant information sheet (n = 51) or an informational video clip (n = 56) as part of an email contact following a screening phase.,['One hundred seven participants'],"['video clip', 'participant information sheet (n\u2009=\u200951) or an informational video clip']",[],"[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205453', 'cui_str': '7'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0175722', 'cui_str': 'Clip'}, {'cui': 'C0439643', 'cui_str': 'Sheets'}]",[],107.0,0.358289,One hundred seven participants were randomised to receive either a participant information sheet (n = 51) or an informational video clip (n = 56) as part of an email contact following a screening phase.,"[{'ForeName': 'Holly C', 'Initials': 'HC', 'LastName': 'Mattock', 'Affiliation': 'Centre for Psychiatry, Imperial College London, London, UK.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Ryan', 'Affiliation': 'Centre for Psychiatry, Imperial College London, London, UK.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': ""O'Farrelly"", 'Affiliation': 'Centre for Psychiatry, Imperial College London, London, UK.'}, {'ForeName': 'Daphne', 'Initials': 'D', 'LastName': 'Babalis', 'Affiliation': 'Imperial Clinical Trials Unit, Imperial College London, London, UK.'}, {'ForeName': 'Paul G', 'Initials': 'PG', 'LastName': 'Ramchandani', 'Affiliation': 'Centre for Psychiatry, Imperial College London, London, UK. pr441@cam.ac.uk.'}]",Trials,['10.1186/s13063-020-04779-0']
3469,33059765,Short-term fasting accompanying chemotherapy as a supportive therapy in gynecological cancer: protocol for a multicenter randomized controlled clinical trial.,"BACKGROUND/OBJECTIVES


A few preliminary studies have documented the safety and feasibility of repeated short-term fasting in patients undergoing chemotherapy. However, there is a lack of data from larger randomized trials on the effects of short-term fasting on quality of life, reduction of side effects during chemotherapy, and a possible reduction of tumor progression. Moreover, no data is available on the effectiveness of fasting approaches compared to so-called healthy diets. We aim to investigate whether the potentially beneficial effects of short-term fasting can be confirmed in a larger randomized trial and can compare favorably to a plant-based wholefood diet.
METHODS


This is a multicenter, randomized, controlled, two-armed interventional study with a parallel group assignment. One hundred fifty patients, including 120 breast cancer patients and 30 patients with ovarian cancer, are to be randomized to one of two nutritional interventions accompanying chemotherapy: (1) repeated short-term fasting with a maximum energy supply of 350-400 kcal on fasting days or (2) repeated short-term normocaloric plant-based diet with restriction of refined carbohydrates. The primary outcome is disease-related quality of life, as assessed by the functional assessment of the chronic illness therapy measurement system. Secondary outcomes include changes in the Hospital Anxiety and Depression Score and as well as frequency and severity of chemotherapy-induced side effects based on the Common Terminology Criteria of Adverse Events. Explorative analysis in a subpopulation will compare histological complete remissions in patients with neoadjuvant treatments.
DISCUSSION/PLANNED OUTCOMES


Preclinical data and a small number of clinical studies suggest that repeated short-term fasting may reduce the side effects of chemotherapy, enhance quality of life, and eventually slow down tumor progression. Experimental research suggests that the effects of fasting may partly be caused by the restriction of animal protein and refined carbohydrates. This study is the first confirmatory, randomized controlled, clinical study, comparing the effects of short-term fasting to a short-term, plant-based, low-sugar diet during chemotherapy on quality of life and histological tumor remission.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03162289 . Registered on 22 May 2017.",2020,"The primary outcome is disease-related quality of life, as assessed by the functional assessment of the chronic illness therapy measurement system.","['patients undergoing chemotherapy', 'One hundred fifty patients, including 120 breast cancer patients and 30 patients with ovarian cancer', 'patients with neoadjuvant treatments', 'gynecological cancer']","['short-term fasting to a short-term, plant-based, low-sugar diet during chemotherapy', 'Short-term fasting accompanying chemotherapy', 'plant-based wholefood diet', 'nutritional interventions accompanying chemotherapy: (1) repeated short-term fasting with a maximum energy supply of 350-400\u2009kcal on fasting days or (2) repeated short-term normocaloric plant-based diet with restriction of refined carbohydrates']","['Hospital Anxiety and Depression Score and as well as frequency and severity of chemotherapy-induced side effects based on the Common Terminology Criteria of Adverse Events', 'disease-related quality of life, as assessed by the functional assessment of the chronic illness therapy measurement system', 'histological complete remissions', 'quality of life, reduction of side effects', 'quality of life and histological tumor remission']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0032098', 'cui_str': 'Kingdom Viridiplantae'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0452316', 'cui_str': 'Low sugar diet'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C5197846', 'cui_str': 'Diet, Plant-Based'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0175898', 'cui_str': 'Refined carbohydrate'}]","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0028275', 'cui_str': 'Terminology'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}]",,0.0886616,"The primary outcome is disease-related quality of life, as assessed by the functional assessment of the chronic illness therapy measurement system.","[{'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Koppold-Liebscher', 'Affiliation': 'Institute of Social Medicine, Epidemiology and Health Economics, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany. daniela.liebscher@charite.de.'}, {'ForeName': 'Christian S', 'Initials': 'CS', 'LastName': 'Kessler', 'Affiliation': 'Institute of Social Medicine, Epidemiology and Health Economics, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Nico', 'Initials': 'N', 'LastName': 'Steckhan', 'Affiliation': 'Institute of Social Medicine, Epidemiology and Health Economics, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Bähr', 'Affiliation': 'Institute of Social Medicine, Epidemiology and Health Economics, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Cornelia', 'Initials': 'C', 'LastName': 'Kempter', 'Affiliation': 'Department of Gynecology, Waldfriede Hospital, Berlin, Germany.'}, {'ForeName': 'Manfred', 'Initials': 'M', 'LastName': 'Wischnewsky', 'Affiliation': 'Department of Mathematics and Computer Science, University of Bremen, Bremen, Germany.'}, {'ForeName': 'Marisa', 'Initials': 'M', 'LastName': 'Hübner', 'Affiliation': 'Institute of Social Medicine, Epidemiology and Health Economics, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Kunz', 'Affiliation': 'Institute of Social Medicine, Epidemiology and Health Economics, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Paul', 'Affiliation': 'Vivantes Hospital Breast Centre, Berlin, Germany.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Zorn', 'Affiliation': 'Department of Medicine I, Section of Clinical Nutrition and Dietetics, Medical Center - University of Freiburg, Freiburg im Breisgau, Germany.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Sari', 'Affiliation': 'Department of Nutrition, Technische Universität München, Munich, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Jeitler', 'Affiliation': 'Institute of Social Medicine, Epidemiology and Health Economics, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Stange', 'Affiliation': 'Institute of Social Medicine, Epidemiology and Health Economics, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Michalsen', 'Affiliation': 'Institute of Social Medicine, Epidemiology and Health Economics, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}]",Trials,['10.1186/s13063-020-04700-9']
3470,33059771,"Double-Blind, Randomized, Placebo-Controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of treating Healthcare Professionals with the Adsorbed COVID-19 (Inactivated) Vaccine Manufactured by Sinovac - PROFISCOV: A structured summary of a study protocol for a randomised controlled trial.","OBJECTIVES


To evaluate the efficacy of two doses of the adsorbed vaccine COVID-19 (inactivated) produced by Sinovac in symptomatic individuals, with virological confirmation of COVID-19, two weeks after the completion of the two-dose vaccination regimen, aged 18 years or older who work as health professionals providing care to patients with possible or confirmed COVID-19. To describe the occurrence of adverse reactions associated with the administration of each of two doses of the adsorbed vaccine COVID-19 (inactivated) produced by Sinovac up to one week after vaccination in Adults (18-59 years of age) and Elderly (60 years of age or more).
TRIAL DESIGN


This is a Phase III, randomized, multicenter, endpoint driven, double-blind, placebo-controlled clinical trial to assess the efficacy and safety of the adsorbed vaccine COVID-19 (inactivated) produced by Sinovac. The adsorbed vaccine COVID-19 (inactivated) produced by Sinovac (product under investigation) will be compared to placebo. Voluntary participants will be randomized to receive two intramuscular doses of the investigational product or the placebo, in a 1: 1 ratio, stratified by age group (18 to 59 years and 60 years or more) and will be monitored for one year by active surveillance of COVID-19. Two databases will be established according to the age groups: one for adults (18-59 years) and one for the elderly (60 years of age or older). The threshold to consider the vaccine efficacious will be to reach a protection level of at least 50%, as proposed by the World Health Organization and the FDA. Success in this criterion will be defined by sequential monitoring with adjustment of the lower limit of the 95% confidence interval above 30% for the primary efficacy endpoint.
PARTICIPANTS


Healthy participants and / or participants with clinically controlled disease, of both genders, 18 years of age or older, working as health professionals performing care in units specialized in direct contact with people with possible or confirmed cases of COVID-19. Participation of pregnant women and those who are breastfeeding, as well as those intending to become pregnant within three months after vaccination will not be allowed. Participants will only be included after signing the voluntary Informed Consent Form and ensuring they undergo screening evaluation and conform to all the inclusion and exclusion criteria. All the clinical sites are located in Brazil.
INTERVENTION AND COMPARATOR


Experimental intervention: The vaccine was manufactured by Sinovac Life Sciences (Beijing, China) and contains 3 μg/0.5 mL (equivalent to 600 SU per dose) of inactivated SARS-CoV-2 virus, and aluminium hydroxide as adjuvant. Control comparator: The placebo contains aluminium hydroxide in a 0.5 mL solution The schedule of both, experimental intervention and placebo is two 0.5 mL doses IM (deltoid) with a two week interval.
MAIN OUTCOMES


The primary efficacy endpoint is the incidence of symptomatic cases of virologically confirmed COVID-19 two weeks after the second vaccination. The virological diagnosis will be confirmed by detection of SARS-CoV-2 nucleic acid in a clinical sample. The primary safety endpoint is the frequency of solicited and unsolicited local and systemic adverse reactions during the period of one week after vaccination according to age group in adult (18-59 years old) and elder (60 years of age or older) subjects. Adverse reactions are defined as adverse events that have a reasonable causal relationship to vaccination.
RANDOMISATION


There will be two randomization lists, one for each age group, based on the investigational products to be administered, i.e., vaccine or placebo at a 1: 1 ratio. Each randomization list will be made to include up to 11,800 (18-59 year-old) adults, and 1,260 elderly (60 y-o and older) participants, the maximum number of participants needed per age group. An electronic central randomization system will be used to designate the investigational product that each participant must receive.
BLINDING (MASKING)


This trial is designed as a double-blind study to avoid introducing bias in the evaluation of efficacy, safety and immunogenicity. The clinical care team, the professionals responsible for the vaccination and the participants will not know which investigational product will be administered. Only pharmacists or nurses in the study who are responsible for the randomization, separation and blinding of the investigational product will have access to unblinded information. The sponsor's operational team will also remain blind.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)


The total number of participants needed to evaluate efficacy, 13,060 participants, satisfies the needed sample size calculated to evaluate safety. Therefore, the total number obtained for efficacy will be the number retained for the study. Up to 13,060 participants are expected to enter the study, with up to 11,800 participants aged 18 to 59 years and 1,260 elderly participants aged 60 and over. Half of the participants of each group will receive the experimental vaccine and half of them will receive the placebo. The recruitment of participants may be modified as recommended by the Data Safety Monitoring Committee at time of the interim unblinded analysis or blind assessment of the COVID-19 attack rate during the study.
TRIAL STATUS


Protocol version 2.0 - 24-Aug-2020. Recruitment started on July 21 st , 2020. The recruitment is expected to conclude in October 2020.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT0445659 . Registry on 2 July 2020 FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,The primary safety endpoint is the frequency of solicited and unsolicited local and systemic adverse reactions during the period of one week after vaccination according to age group in adult (18-59 years old) and elder (60 years of age or older) subjects.,"['symptomatic individuals, with virological confirmation of COVID-19, two weeks after the completion of the two-dose vaccination regimen, aged 18 years or older who work as health professionals providing care to patients with possible or confirmed COVID-19', 'pregnant women', 'Healthy participants and / or participants with clinically controlled disease, of both genders, 18 years of age or older, working as health professionals performing care in units specialized in direct contact with people with possible or confirmed cases of COVID-19', 'Registry on 2 July 2020', 'age groups: one for adults (18-59 years) and one for the elderly (60 years of age or older', 'in Adults (18-59 years of age) and Elderly (60 years of age or more', '11,800 (18-59 year-old) adults, and 1,260 elderly (60 y-o and older) participants, the maximum number of participants needed per age group', '13,060 participants are expected to enter the study, with up to 11,800 participants aged 18 to 59 years and 1,260 elderly participants aged 60 and over', 'Voluntary participants']","['adsorbed vaccine COVID-19 (inactivated) produced by Sinovac up to one week after vaccination', 'adsorbed vaccine COVID-19 (inactivated) produced by Sinovac', 'placebo contains aluminium hydroxide', 'vaccine or placebo', 'vaccine was manufactured by Sinovac Life Sciences (Beijing, China) and contains 3 μg/0.5 mL (equivalent to 600 SU per dose) of inactivated SARS-CoV-2 virus, and aluminium hydroxide', 'placebo', 'adsorbed vaccine COVID-19 (inactivated', 'Adsorbed COVID-19 (Inactivated) Vaccine Manufactured by Sinovac - PROFISCOV', 'Placebo']","['frequency of solicited and unsolicited local and systemic adverse reactions', 'efficacy, safety and immunogenicity', 'efficacy and safety', 'Efficacy and Safety', 'incidence of symptomatic cases']","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205466', 'cui_str': 'Virologic'}, {'cui': 'C0521091', 'cui_str': 'Confirmation of'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C4082118', 'cui_str': 'Two weeks'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0002371', 'cui_str': 'Aluminum Hydroxide'}, {'cui': 'C0005526', 'cui_str': 'Biological Sciences'}, {'cui': 'C4042832', 'cui_str': 'Peking'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0868928', 'cui_str': 'Case'}]",2.0,0.413425,The primary safety endpoint is the frequency of solicited and unsolicited local and systemic adverse reactions during the period of one week after vaccination according to age group in adult (18-59 years old) and elder (60 years of age or older) subjects.,"[{'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Palacios', 'Affiliation': 'Center for Clinical Trials and Pharmacovigilance, Instituto Butantan, São Paulo, Brazil. ricardo.palacios@butantan.gov.br.'}, {'ForeName': 'Elizabeth González', 'Initials': 'EG', 'LastName': 'Patiño', 'Affiliation': 'Center for Clinical Trials and Pharmacovigilance, Instituto Butantan, São Paulo, Brazil.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'de Oliveira Piorelli', 'Affiliation': 'Center for Clinical Trials and Pharmacovigilance, Instituto Butantan, São Paulo, Brazil.'}, {'ForeName': 'Monica Tilli Reis Pessoa', 'Initials': 'MTRP', 'LastName': 'Conde', 'Affiliation': 'Center for Clinical Trials and Pharmacovigilance, Instituto Butantan, São Paulo, Brazil.'}, {'ForeName': 'Ana Paula', 'Initials': 'AP', 'LastName': 'Batista', 'Affiliation': 'Center for Clinical Trials and Pharmacovigilance, Instituto Butantan, São Paulo, Brazil.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Zeng', 'Affiliation': 'Sinovac Life Sciences, Beijing, China.'}, {'ForeName': 'Qianqian', 'Initials': 'Q', 'LastName': 'Xin', 'Affiliation': 'Sinovac Life Sciences, Beijing, China.'}, {'ForeName': 'Esper G', 'Initials': 'EG', 'LastName': 'Kallas', 'Affiliation': 'Department of Infectious and Parasitic Diseases, School of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Flores', 'Affiliation': 'PATH US, Washington DC, USA.'}, {'ForeName': 'Christian F', 'Initials': 'CF', 'LastName': 'Ockenhouse', 'Affiliation': 'PATH US, Washington DC, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Gast', 'Affiliation': 'PATH, Seattle, WA, USA.'}]",Trials,['10.1186/s13063-020-04775-4']
3471,33059801,[A comparative analysis of the efficacy of two vitamin D supplementation regimens in preterm infants: a prospective randomized controlled study].,"OBJECTIVE


To study the effect of different vitamin D supplementation regimens on the nutritional status of vitamin D on day 28 after birth in preterm infants with a gestational age of <34 weeks.
METHODS


A total of 59 preterm infants with a gestational age of <34 weeks who were born from October 2018 to October 2019 were enrolled and divided into an observation group with 30 infants and a control group with 29 infants. The infants in the observation group received a single-dose intramuscular injection of vitamin D 3  (10 000 IU/kg), while those in the control group received oral vitamin D 3  drops (900 IU/d) for 25 days. Venous blood samples were collected within 48 hours after birth (before vitamin D 3  supplementation) and on day 28 after birth to measure the serum 25-hydroxyvitamin D [25(OH)D] level.
RESULTS


Within 48 hours after birth, the prevalence rate of vitamin D deficiency (≤15 ng/mL) was 78% among the 59 preterm infants. There were no significant differences in the serum 25(OH)D level and the prevalence rate of vitamin D deficiency between the two groups (P>0.05). Compared with the control group on day 28 after birth, the observation group had a significantly higher serum 25(OH)D level (P<0.05) and a significantly lower prevalence rate of vitamin D deficiency (P<0.05). There were no cases of vitamin D overdose or poisoning.
CONCLUSIONS


In preterm infants with a gestational age of <34 weeks, single-dose intramuscular injection of 10 000 IU/kg vitamin D 3  can significantly increase serum 25(OH)D level on day 28 after birth and safely and effectively reduce the prevalence rate of vitamin D deficiency.",2020,There were no significant differences in the serum 25(OH)D level and the prevalence rate of vitamin D deficiency between the two groups (P>0.05).,"['preterm infants', 'day 28 after birth in preterm infants with a gestational age of <34 weeks', '59 preterm infants', '59 preterm infants with a gestational age of <34 weeks who were born from October 2018 to October 2019 were enrolled and divided into an observation group with 30 infants and a control group with 29 infants', 'preterm infants with a gestational age of <34 weeks']","['oral vitamin D 3  drops', 'single-dose intramuscular injection of vitamin D', 'vitamin D supplementation regimens']","['serum 25-hydroxyvitamin D [25(OH)D] level', 'nutritional status of vitamin D', 'Venous blood samples', 'prevalence rate of vitamin D deficiency', 'serum 25(OH)D level and the prevalence rate of vitamin D deficiency', 'serum 25(OH)D level', 'vitamin D overdose or poisoning']","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0021492', 'cui_str': 'Intramuscular injection'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0444255', 'cui_str': 'Venous blood specimen'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D deficiency'}, {'cui': 'C0573817', 'cui_str': 'Vitamin D overdose'}, {'cui': 'C0032343', 'cui_str': 'Poisoning'}]",59.0,0.0793967,There were no significant differences in the serum 25(OH)D level and the prevalence rate of vitamin D deficiency between the two groups (P>0.05).,"[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Ma', 'Affiliation': ""Department of Neonatology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an 710061, China. zhouxih@mail.xjtu.edu.cn.""}, {'ForeName': 'Li-Meng', 'Initials': 'LM', 'LastName': 'Geng', 'Affiliation': ''}, {'ForeName': 'Xi-Hui', 'Initials': 'XH', 'LastName': 'Zhou', 'Affiliation': ''}]",Zhongguo dang dai er ke za zhi = Chinese journal of contemporary pediatrics,[]
3472,33060092,Cluster-randomised trial of community-based screening for eye disease in adults in Nepal: the Village-Integrated Eye Worker Trial II (VIEW II) trial protocol.,"INTRODUCTION


The majority of blindness worldwide could be prevented or reversed with early diagnosis and treatment, yet identifying at-risk and prevalent cases of eye disease and linking them with care remain important obstacles to addressing this burden. Leading causes of blindness like glaucoma, diabetic retinopathy and age-related macular degeneration have detectable early asymptomatic phases and can cause irreversible vision loss. Mass screening for such diseases could reduce visual impairment at the population level.
METHODS AND ANALYSIS


This protocol describes a parallel-group cluster-randomised trial designed to determine whether community-based screening for glaucoma, diabetic retinopathy and age-related macular degeneration reduces population-level visual impairment in Nepal. A door-to-door population census is conducted in all study communities. All adults aged ≥60 years have visual acuity tested at the census visit, and those meeting referral criteria are referred to a local eye care facility for further diagnosis and management. Communities are subsequently randomised to a community-based screening programme or to no additional intervention. The intervention consists of a single round of screening including intraocular pressure and optical coherence tomography assessment of all adults ≥60 years old with enhanced linkage to care for participants meeting referral criteria. Four years after implementation of the intervention, masked outcome assessors conduct a repeat census to collect data on the primary outcome, visual acuity. Individuals with incident visual impairment receive a comprehensive ophthalmological examination to determine the cause of visual impairment. Outcomes are compared by treatment arm according to the originally assigned intervention.
ETHICS AND DISSEMINATION


The trial has received ethical approval from the University of California San Francisco Institutional Review Board, Nepal Netra Jyoti Sangh and the Nepal Health Research Council. Results of this trial will be disseminated through publication in peer-reviewed journals and presentation at local and international meetings.
TRIAL REGISTRATION NUMBER


NCT03752840.",2020,"Leading causes of blindness like glaucoma, diabetic retinopathy and age-related macular degeneration have detectable early asymptomatic phases and can cause irreversible vision loss.","['All adults aged ≥60 years have visual acuity tested at the census visit, and those meeting referral criteria are referred to a local eye care facility for further diagnosis and management', 'all adults ≥60 years old with enhanced linkage to care for participants meeting referral criteria', 'Individuals with incident visual impairment', 'adults in Nepal', 'for glaucoma, diabetic retinopathy and age-related macular degeneration reduces population-level visual impairment in Nepal']","['community-based screening', 'single round of screening including intraocular pressure and optical coherence tomography assessment of']",['visual acuity'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0200150', 'cui_str': 'Visual acuity testing'}, {'cui': 'C0007663', 'cui_str': 'Census'}, {'cui': 'C0556656', 'cui_str': 'Meetings'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0885957', 'cui_str': 'Eye care'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0042798', 'cui_str': 'Dim vision'}, {'cui': 'C0027689', 'cui_str': 'Nepal'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0011884', 'cui_str': 'Retinopathy due to diabetes mellitus'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0024437', 'cui_str': 'Degenerative disorder of macula'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0332490', 'cui_str': 'Round shape'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0042812', 'cui_str': 'Visual acuity'}]",,0.404081,"Leading causes of blindness like glaucoma, diabetic retinopathy and age-related macular degeneration have detectable early asymptomatic phases and can cause irreversible vision loss.","[{'ForeName': 'Kieran S', 'Initials': 'KS', 'LastName': ""O'Brien"", 'Affiliation': 'Francis I Proctor Foundation, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Valerie M', 'Initials': 'VM', 'LastName': 'Stevens', 'Affiliation': 'Francis I Proctor Foundation, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Raghunandan', 'Initials': 'R', 'LastName': 'Byanju', 'Affiliation': 'Bharatpur Eye Hospital, Bharatpur, Nepal.'}, {'ForeName': 'Ram Prasad', 'Initials': 'RP', 'LastName': 'Kandel', 'Affiliation': 'Seva Foundation, Bharatpur, Nepal.'}, {'ForeName': 'Gopal', 'Initials': 'G', 'LastName': 'Bhandari', 'Affiliation': 'Bharatpur Eye Hospital, Bharatpur, Nepal.'}, {'ForeName': 'Sadhan', 'Initials': 'S', 'LastName': 'Bhandari', 'Affiliation': 'Bharatpur Eye Hospital, Bharatpur, Nepal.'}, {'ForeName': 'Jason S', 'Initials': 'JS', 'LastName': 'Melo', 'Affiliation': 'Francis I Proctor Foundation, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Travis C', 'Initials': 'TC', 'LastName': 'Porco', 'Affiliation': 'Francis I Proctor Foundation, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Lietman', 'Affiliation': 'Francis I Proctor Foundation, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Jeremy D', 'Initials': 'JD', 'LastName': 'Keenan', 'Affiliation': 'Francis I Proctor Foundation, University of California San Francisco, San Francisco, California, USA jeremy.keenan@ucsf.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2020-040219']
3473,33060126,Effect of BATHE interview technique on patient satisfaction in an ambulatory family medicine centre in South India.,"OBJECTIVE


The objective of the study is to determine the effect of background, affect, trouble, handling and empathy (BATHE) versus usual interview technique on patient satisfaction during regular consultation with family physicians in ambulatory care.
DESIGN


The research design was a prospective, randomised control trial.
SETTING


The trial took place in a family practice unit in South India, which was one of the clinical service units of the academic Department of Family Medicine of a tertiary hospital.
PARTICIPANT


The eligible participants were adults above the age of 18 years, who did not have any acute presenting illness. The participants should have given consent and also not have any cognitive disability. A total of 138 participants took part in the trial, 70 in BATHE group and 68 in the non-BATHE group. All participants entering the trial completed the questionnaire.
RESULT


The BATHE group had a significantly higher mean score for questions grouped under professional satisfaction. This included questions on whether the patient felt that the physician treated them as a person and also whether they felt the appropriate clinical examination was communicated to them. The questionnaire used for scoring satisfaction had 18 questions with a maximum possible score of 90. When taking a cut-off of 75% (68) from the total possible score of 90, 72.9% (51) of the participants for whom the BATHE consultation technique was used were satisfied as compared with only 55.9% (30) for whom the routine consultation was carried out. This was statistically significant (χ 2 =11.15, p value=0.0006) CONCLUSION: The study suggests that using BATHE in this family practice centre is beneficial in improving the perception of person centeredness in the consultation. However, further studies ruling out all possible bias are needed in our setting before the range of probable benefits of the BATHE technique can be fully gauged.",2020,The BATHE group had a significantly higher mean score for questions grouped under professional satisfaction.,"['The trial took place in a family practice unit in South India, which was one of the clinical service units of the academic Department of Family Medicine of a tertiary hospital', 'patient satisfaction in an ambulatory family medicine centre in South India', 'eligible participants were adults above the age of 18 years, who did not have any acute presenting illness', 'patient satisfaction during regular consultation with family physicians in ambulatory care', '138 participants took part in the trial, 70 in BATHE group and 68 in the non-BATHE group']",['usual interview technique'],[],"[{'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C1704221', 'cui_str': 'Family medicine specialist'}, {'cui': 'C0002423', 'cui_str': 'Outpatient Care'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0025664', 'cui_str': 'methods'}]",[],138.0,0.0481547,The BATHE group had a significantly higher mean score for questions grouped under professional satisfaction.,"[{'ForeName': 'Navnee', 'Initials': 'N', 'LastName': 'Chengappa', 'Affiliation': 'Department of Family Medicine, Christian Medical College, Vellore, Tamil Nadu, India.'}, {'ForeName': 'Prince Christopher', 'Initials': 'PC', 'LastName': 'Rajkumar Honest', 'Affiliation': 'Department of Family Medicine, Christian Medical College, Vellore, Tamil Nadu, India prince.christopher@gmail.com.'}, {'ForeName': 'Kirubah', 'Initials': 'K', 'LastName': 'David', 'Affiliation': 'Department of Family Medicine, Christian Medical College, Vellore, Tamil Nadu, India.'}, {'ForeName': 'Ruby Angeline', 'Initials': 'RA', 'LastName': 'Pricilla', 'Affiliation': 'Department of Community Medicine, Christian Medical College, Vellore, Tamil Nadu, India.'}, {'ForeName': 'Sajitha Mf', 'Initials': 'SM', 'LastName': 'Rahman', 'Affiliation': 'Department of Family Medicine, Christian Medical College, Vellore, Tamil Nadu, India.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Rebecca', 'Affiliation': 'Department of Biostatistics, Christian Medical College, Vellore, Tamil Nadu, India.'}]",Family medicine and community health,['10.1136/fmch-2020-000327']
3474,33060999,Impact of occult renal disease on the outcomes of off-pump and on-pump coronary artery bypass grafting.,"Purpose


Occult renal disease (ORD) is a clinical condition in which glomerular filtration rate (GFR) is less than 60 ml/min/1.73 m 2 , while serum creatinine is ≤ 1.3 mg/dl. The aim of the study was to compare the incidence of postoperative stage I acute kidney injury (AKI) according to Acute Kidney Injury Network (AKIN) classification in patients with ORD undergoing either off-pump or on-pump coronary artery bypass grafting.
Methods


A single center prospective randomized study was conducted from March 2011 through January 2014. A total of 120 coronary artery disease (CAD) patients with ORD undergoing coronary artery bypass grafting (CABG) were randomized to either off-pump (group1,  n  = 62) or on-pump (group2,  n  = 58) CABG in 1:1 ratio by computer-generated random number table. The GFR and serum creatinine levels were measured preoperatively and postoperatively on day 1 and day 5. The primary outcome (postoperative AKI (stage I)) and secondary outcomes (AKI (stage III) requiring renal replacement therapy (RRT) death, myocardial infarction (MI), cerebrovascular accident, atrial fibrillation (AF), and re-exploration for bleeding) at 30 days were analyzed between the groups.
Results


There is no significant difference in baseline characteristics of patients between off-pump and on-pump group. The incidence of postoperative AKI (stage I) was similar between on-pump (20.69%) and off-pump (16.13%) groups ( p  = 0.51). There was no significant difference in mortality ( p  = 0.33), postoperative MI ( p  = 0.34), cerebrovascular accident ( p  = 1.00), re-exploration ( p  = 0.96), and AF ( p  = 0.50). The number of patients of stage III AKI requiring RRT was higher in the off-pump group (3 patients, 4.8%) and none in the on-pump group ( p  = 0.08).
Conclusions


This study demonstrated that on-pump CABG is associated with significantly lower GFR and significantly higher serum creatinine on postoperative day 1 which return to baseline by postoperative day 5. In patients with ORD undergoing CABG, the incidence of postoperative AKI and major adverse cardiac and cerebrovascular events were similar between off-pump or on-pump CABG patients.",2019,"There was no significant difference in mortality ( p  = 0.33), postoperative MI ( p  = 0.34), cerebrovascular accident ( p  = 1.00), re-exploration ( p  = 0.96), and AF ( p  = 0.50).","['patients with ORD undergoing either off-pump or on-pump coronary artery bypass grafting', 'patients with ORD undergoing', 'March 2011 through January 2014', '120 coronary artery disease (CAD) patients with ORD undergoing coronary artery bypass grafting (CABG']","['CABG', 'pump and on-pump coronary artery bypass grafting', 'pump (group1,  n \u2009=\u200962) or on-pump (group2,  n \u2009=\u200958']","['GFR and serum creatinine levels', 'primary outcome (postoperative AKI (stage I)) and secondary outcomes (AKI (stage III) requiring renal replacement therapy (RRT) death, myocardial infarction (MI), cerebrovascular accident, atrial fibrillation (AF), and re-exploration for bleeding', 'postoperative MI', 'incidence of postoperative AKI and major adverse cardiac and cerebrovascular events', 'number of patients of stage III AKI requiring RRT', 'incidence of postoperative AKI (stage I', 'cerebrovascular accident', 'mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028794', 'cui_str': 'Occultism'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}]","[{'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0182537', 'cui_str': 'Pump'}]","[{'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C1293095', 'cui_str': 'Reexploration procedure'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",120.0,0.212315,"There was no significant difference in mortality ( p  = 0.33), postoperative MI ( p  = 0.34), cerebrovascular accident ( p  = 1.00), re-exploration ( p  = 0.96), and AF ( p  = 0.50).","[{'ForeName': 'Lokeswara Rao', 'Initials': 'LR', 'LastName': 'Sajja', 'Affiliation': 'Division of Cardiothoracic Surgery, Star Hospitals, Road no. 10, Banjara Hills, Hyderabad, Telangana 500 034 India.'}, {'ForeName': 'Sudhanshu', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': 'Division of Cardiothoracic Surgery, Star Hospitals, Road no. 10, Banjara Hills, Hyderabad, Telangana 500 034 India.'}, {'ForeName': 'Gopichand', 'Initials': 'G', 'LastName': 'Mannam', 'Affiliation': 'Division of Cardiothoracic Surgery, Star Hospitals, Road no. 10, Banjara Hills, Hyderabad, Telangana 500 034 India.'}, {'ForeName': 'Jyothsna', 'Initials': 'J', 'LastName': 'Guttikonda', 'Affiliation': 'Sajja Heart Foundation, Srinagar Colony, Hyderabad, 500 073 India.'}, {'ForeName': 'Venkata Ramachandra Raju', 'Initials': 'VRR', 'LastName': 'Pusapati', 'Affiliation': 'Sajja Heart Foundation, Srinagar Colony, Hyderabad, 500 073 India.'}, {'ForeName': 'Krishnamurthy Venkata Satya Siva', 'Initials': 'KVSS', 'LastName': 'Saikiran', 'Affiliation': 'Division of Cardiothoracic Surgery, Star Hospitals, Road no. 10, Banjara Hills, Hyderabad, Telangana 500 034 India.'}]","Indian journal of thoracic and cardiovascular surgery : official organ, Association of Thoracic and Cardiovascular Surgeons of India",['10.1007/s12055-018-0767-3']
3475,33061000,"""RFEF"" and mitral regurgitation jet direction: surrogate markers for likelihood of left ventricle reverse remodeling in patients with moderate chronic ischemic mitral regurgitation.","Purpose


Surgical management of moderate chronic ischemic mitral regurgitation (CIMR) is controversial. We propose a simplified classification of moderate CIMR based on regurgitant fraction (RF), ejection fraction (EF), and jet direction (central/eccentric) to predict left ventricle (LV) remodeling and identify patient subsets which need mitral valve (MV) repair along with coronary artery bypass grafting (CABG).
Methods


In this prospective controlled study ( n  = 210), patients with moderate CIMR were randomized. Group I ( n  = 106) underwent off-pump CABG alone while group II ( n  = 104) underwent CABG + MV repair. The product of regurgitation fraction and ejection fraction (""RFEF"") was taken as a surrogate for myocardial reserve. The cut-off defined was 0.12; patients with RFEF ≤ 0.12 were categorized as the ""bad"" and those with RFEF > 0.12 as the ""good"" subset. The patients were further subdivided on the basis of their mitral regurgitation (MR) jet direction (central/eccentric). The percentage improvement in left ventricular end-systolic volume index (LVESVI) and MR grade were recorded 6 monthly.
Results


Analysis of the continuous variable ""RFEF"" in conjunction with jet direction was performed. At 12 months, the patient in good subset with central direction of jet showed improvement in LVESVI % in both groups ( p  = 0.428), while the patients in bad subset with eccentric direction of jet showed significantly higher improvement in LVESVI %, group II as compared to group I ( p  = 0.004).
Conclusion


This study thus identifies ""RFEF"" as a surrogate for reverse remodeling capacity. In association with MR jet direction, predicts the subset of moderate CIMR patients most likely to have maximum LVESVI and MR grade reduction.",2019,"We propose a simplified classification of moderate CIMR based on regurgitant fraction (RF), ejection fraction (EF), and jet direction (central/eccentric) to predict left ventricle (LV) remodeling and identify patient subsets which need mitral valve (MV) repair along with coronary artery bypass grafting (CABG).
","['moderate chronic ischemic mitral regurgitation (CIMR', ' n \u2009=\u2009210), patients with moderate CIMR', 'patients with moderate chronic ischemic mitral regurgitation']","['CABG + MV repair', 'RFEF"" and mitral regurgitation jet direction', 'pump CABG alone', 'coronary artery bypass grafting (CABG']","['regurgitant fraction (RF), ejection fraction (EF), and jet direction (central/eccentric', 'product of regurgitation fraction and ejection fraction (""RFEF', 'left ventricular end-systolic volume index (LVESVI) and MR grade', 'LVESVI']","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C4087284', 'cui_str': 'Ischaemic mitral regurgitation'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0396849', 'cui_str': 'Mitral valvuloplasty'}, {'cui': 'C0026266', 'cui_str': 'Mitral valve regurgitation'}, {'cui': 'C0336862', 'cui_str': 'Jet airplane'}, {'cui': 'C0439755', 'cui_str': 'Directions'}, {'cui': 'C0182537', 'cui_str': 'Pump'}]","[{'cui': 'C1302309', 'cui_str': 'Regurgitant fraction'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0336862', 'cui_str': 'Jet airplane'}, {'cui': 'C0439755', 'cui_str': 'Directions'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0439740', 'cui_str': 'Eccentric'}, {'cui': 'C0232605', 'cui_str': 'Regurgitates after swallowing'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0080308', 'cui_str': 'Ventricular End-Systolic Volume'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0441800', 'cui_str': 'Grade'}]",,0.0190204,"We propose a simplified classification of moderate CIMR based on regurgitant fraction (RF), ejection fraction (EF), and jet direction (central/eccentric) to predict left ventricle (LV) remodeling and identify patient subsets which need mitral valve (MV) repair along with coronary artery bypass grafting (CABG).
","[{'ForeName': 'Sumbul', 'Initials': 'S', 'LastName': 'Siddiqui', 'Affiliation': 'Department of Cardiovascular and Thoracic Surgery, U. N. Mehta Institute of Cardiology and Research Center (Affiliated to BJ Medical College, Ahmedabad), Civil Hospital Campus, Asarwa, Ahmedabad, Gujarat 380016 India.'}, {'ForeName': 'Amber', 'Initials': 'A', 'LastName': 'Malhotra', 'Affiliation': 'Department of Cardiovascular and Thoracic Surgery, U. N. Mehta Institute of Cardiology and Research Center (Affiliated to BJ Medical College, Ahmedabad), Civil Hospital Campus, Asarwa, Ahmedabad, Gujarat 380016 India.'}, {'ForeName': 'Komal', 'Initials': 'K', 'LastName': 'Shah', 'Affiliation': 'Department of Research, U. N. Mehta Institute of Cardiology and Research Center (Affiliated to BJ Medical College, Ahmedabad), Ahmedabad, India.'}, {'ForeName': 'Pankaj', 'Initials': 'P', 'LastName': 'Garg', 'Affiliation': 'Department of Cardiovascular and Thoracic Surgery, U. N. Mehta Institute of Cardiology and Research Center (Affiliated to BJ Medical College, Ahmedabad), Civil Hospital Campus, Asarwa, Ahmedabad, Gujarat 380016 India.'}, {'ForeName': 'Pranav', 'Initials': 'P', 'LastName': 'Sharma', 'Affiliation': 'Department of Cardiovascular and Thoracic Surgery, U. N. Mehta Institute of Cardiology and Research Center (Affiliated to BJ Medical College, Ahmedabad), Civil Hospital Campus, Asarwa, Ahmedabad, Gujarat 380016 India.'}, {'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Wadhawa', 'Affiliation': 'Department of Cardiovascular and Thoracic Surgery, U. N. Mehta Institute of Cardiology and Research Center (Affiliated to BJ Medical College, Ahmedabad), Civil Hospital Campus, Asarwa, Ahmedabad, Gujarat 380016 India.'}, {'ForeName': 'Kartik', 'Initials': 'K', 'LastName': 'Patel', 'Affiliation': 'Department of Cardiovascular and Thoracic Surgery, U. N. Mehta Institute of Cardiology and Research Center (Affiliated to BJ Medical College, Ahmedabad), Civil Hospital Campus, Asarwa, Ahmedabad, Gujarat 380016 India.'}, {'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Shukla', 'Affiliation': 'Department of Cardiology, U. N. Mehta Institute of Cardiology and Research Center (Affiliated to BJ Medical College, Ahmedabad), Ahmedabad, India.'}]","Indian journal of thoracic and cardiovascular surgery : official organ, Association of Thoracic and Cardiovascular Surgeons of India",['10.1007/s12055-018-0717-0']
3476,33061023,Five-year clinical outcomes of diabetic patients in the Randomized On/Off Bypass Follow-up (ROOBY-FS) trial-is the evidence enough to change the practice?,,2019,,['diabetic patients'],[],[],"[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],[],,0.0955796,,"[{'ForeName': 'Pradeep', 'Initials': 'P', 'LastName': 'Narayan', 'Affiliation': 'Department of Cardiac Surgery, NH Rabindranath Tagore International Institute of Cardiac Sciences (RTIICS), Kolkata, 700099 India.'}]","Indian journal of thoracic and cardiovascular surgery : official organ, Association of Thoracic and Cardiovascular Surgeons of India",['10.1007/s12055-018-00781-z']
3477,33061029,Effect of goal-directed therapy on post-operative neutrophil gelatinase-associated lipocalin profile in patients undergoing on-pump coronary artery surgery.,"Purpose


Neutrophil gelatinase-associated lipocalin (NGAL) is an early biomarker of acute kidney injury (AKI). Goal-directed therapy (GDT) in on-pump coronary artery bypass grafting (CABG) has been associated with lower post-operative NGAL levels in recent studies. The present study aimed at comparing plasma (P) and urinary (U)-NGAL levels following the use of GDT versus conventional haemodynamic therapy (CT) in patients undergoing on-pump CABG.
Methods


A prospective randomised controlled study conducted in a single university hospital. A total of 54 patients in the GDT group and 56 patients in CT group after exclusions.
Results


U-NGAL was significantly lower immediately post-surgery ( T   1 ) in GDT group (25.11 ± 1.5 versus 27.80 ± 1.7 μg/L;  p  < 0.001) and at 4 h ( T   2 ) (38.19 ± 23.6 versus 52.30 ± 28.3 μg/L;  p  = 0.006) and at 24 h post-operatively ( T   3 ) (34.85 ± 14 versus 39.7 ± 11.1 μg/L;  p  = 0.047). P-NGAL was comparable between groups at  T   1  but lower in the GDT group at  T   2  (92.81 ± 4.8 versus 94.77 ± 4.5 μg/L;  p  = 0.03) and  T   3  (67.44 ± 3.7 versus 75.96 ± 5.3 μg/L;  p  < 0.001). U-NGAL levels correlated well with the peak post-operative creatinine as compared to P-NGAL. On-pump patients manifest neutrophil activation, accounting for comparable levels of P-NGAL in the two groups at  T   1 . GDT-based haemodynamic management resulted in lower U-NGAL levels at  T   1 ,  T   2  and  T   3  and lower P-NGAL levels at  T   2  and  T   3 .
Conclusions


Haemodynamic optimisation with GDT prevents further renal insult initiated with the inflammatory activation with cardiopulmonary bypass (CPB), as evidenced by lower post-operative U-NGAL levels.",2019,"GDT-based haemodynamic management resulted in lower U-NGAL levels at  T   1 ,  T   2  and  T   3  and lower P-NGAL levels at  T   2  and  T   3 .
","['patients undergoing on-pump coronary artery surgery', '54 patients in the GDT group and 56 patients in CT group after exclusions', 'patients undergoing on-pump CABG']","['GDT', 'goal-directed therapy', 'Neutrophil gelatinase-associated lipocalin (NGAL', 'pump coronary artery bypass grafting (CABG', 'GDT versus conventional haemodynamic therapy (CT', 'Goal-directed therapy (GDT']","['plasma (P) and urinary (U)-NGAL levels', 'U-NGAL', 'U-NGAL levels', 'lower U-NGAL levels', 'P-NGAL']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0190188', 'cui_str': 'Operative procedure on coronary artery'}, {'cui': 'C1271494', 'cui_str': 'Goal directed therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C1527374', 'cui_str': 'Group Therapy'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}]","[{'cui': 'C1271494', 'cui_str': 'Goal directed therapy'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0206528', 'cui_str': 'Gelatinase'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C1956074', 'cui_str': 'Lipocalin'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0206528', 'cui_str': 'Gelatinase'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C1956074', 'cui_str': 'Lipocalin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",,0.132515,"GDT-based haemodynamic management resulted in lower U-NGAL levels at  T   1 ,  T   2  and  T   3  and lower P-NGAL levels at  T   2  and  T   3 .
","[{'ForeName': 'Poonam Malhotra', 'Initials': 'PM', 'LastName': 'Kapoor', 'Affiliation': 'Department of Cardiac Anaesthesia, Cardiothoracic Centre, CNC, All India Institute of Medical Sciences, Room No. 8, 7th Floor, Cardiothoracic Centre, Cardiothoracic Centre, Ansari Nagar, New Delhi, 110029 India.'}, {'ForeName': 'Ameya', 'Initials': 'A', 'LastName': 'Karanjkar', 'Affiliation': 'Department of Cardiac Anaesthesia, Cardiothoracic Centre, CNC, All India Institute of Medical Sciences, Room No. 8, 7th Floor, Cardiothoracic Centre, Cardiothoracic Centre, Ansari Nagar, New Delhi, 110029 India.'}, {'ForeName': 'Rohan', 'Initials': 'R', 'LastName': 'Magoon', 'Affiliation': 'Department of Cardiac Anaesthesia, Cardiothoracic Centre, CNC, All India Institute of Medical Sciences, Room No. 8, 7th Floor, Cardiothoracic Centre, Cardiothoracic Centre, Ansari Nagar, New Delhi, 110029 India.'}, {'ForeName': 'Sameer', 'Initials': 'S', 'LastName': 'Taneja', 'Affiliation': 'Department of Cardiac Anaesthesia, Cardiothoracic Centre, CNC, All India Institute of Medical Sciences, Room No. 8, 7th Floor, Cardiothoracic Centre, Cardiothoracic Centre, Ansari Nagar, New Delhi, 110029 India.'}, {'ForeName': 'Sambhunath', 'Initials': 'S', 'LastName': 'Das', 'Affiliation': 'Department of Cardiac Anaesthesia, Cardiothoracic Centre, CNC, All India Institute of Medical Sciences, Room No. 8, 7th Floor, Cardiothoracic Centre, Cardiothoracic Centre, Ansari Nagar, New Delhi, 110029 India.'}, {'ForeName': 'Vishwas', 'Initials': 'V', 'LastName': 'Malik', 'Affiliation': 'Department of Cardiac Anaesthesia, Cardiothoracic Centre, CNC, All India Institute of Medical Sciences, Room No. 8, 7th Floor, Cardiothoracic Centre, Cardiothoracic Centre, Ansari Nagar, New Delhi, 110029 India.'}, {'ForeName': 'Ujjwal Kumar', 'Initials': 'UK', 'LastName': 'Chowdhury', 'Affiliation': 'Cardiothoracic and Vascular Surgery, All India Institute of Medical Sciences, Cardiothoracic Centre, CNC, Ansari Nagar, New Delhi, 110029 India.'}, {'ForeName': 'Vajala', 'Initials': 'V', 'LastName': 'Ravi', 'Affiliation': 'Lady Shri Ram College, University of Delhi, New Delhi, 110024 India.'}]","Indian journal of thoracic and cardiovascular surgery : official organ, Association of Thoracic and Cardiovascular Surgeons of India",['10.1007/s12055-018-0758-4']
3478,33061101,Has Arterial Revascularization Trial [ART] burst the BITA bubble?,"The 10-year outcome of the Arterial Revascularization Trial (ART) has recently been published. The study is the largest randomized study comparing bilateral internal thoracic artery (BITA) with single internal thoracic artery (SITA) as a grafting strategy for coronary artery bypass. In this review, a critical appraisal of the study has been performed where the result of the trial has been discussed along with the risk of sternal wound infections, the presence of a learning curve, and the influence of volume on outcomes. The influence of BITA grafting on other aspects like influence on hospital stay and quality of life outcomes has also been discussed.",2020,The influence of BITA grafting on other aspects like influence on hospital stay and quality of life outcomes has also been discussed.,['coronary artery bypass'],['bilateral internal thoracic artery (BITA) with single internal thoracic artery (SITA'],['hospital stay and quality of life outcomes'],"[{'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0226276', 'cui_str': 'Structure of internal thoracic artery'}, {'cui': 'C0037179', 'cui_str': 'Single person'}]","[{'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.0237355,The influence of BITA grafting on other aspects like influence on hospital stay and quality of life outcomes has also been discussed.,"[{'ForeName': 'Pradeep', 'Initials': 'P', 'LastName': 'Narayan', 'Affiliation': 'Department of Cardiac Surgery, NH Rabindranath Tagore International Institute of Cardiac Sciences, Kolkata, 700099 India.'}]","Indian journal of thoracic and cardiovascular surgery : official organ, Association of Thoracic and Cardiovascular Surgeons of India",['10.1007/s12055-019-00833-y']
3479,33061107,Graft patency at 3 months after off- and on-pump coronary bypass surgery: a randomized trial.,"Purpose


Coronary artery bypass grafting (CABG) is performed either with the aid of cardiopulmonary bypass (on-pump) or without cardiopulmonary bypass (off-pump). There is a scarcity of angiographic data to support the non-inferiority of off-pump technique to on-pump technique. The objective of this study is to ascertain the non-inferiority of off-pump CABG when compared to on-pump CABG in terms of angiographically assessed graft patency at 3 months.
Methods


A total of 320 patients with multivessel coronary artery disease were enrolled in a multicenter prospective randomized trial either to on-pump CABG ( n  = 162) or off-pump CABG ( n  = 158) between March 2016 through March 2017. Graft patency was evaluated by using either multidetector computerized tomographic angiography or conventional coronary angiography at 3 months. The major adverse cardiac and cardiovascular events (MACCE) were also analyzed at 3 months.
Results


The median number of grafts per patient in off-pump was 3.00 (Q1:3.00 and Q3:4.00) vs on-pump 4.00 (Q1:3.00 to Q3:4.00), and the mean number of grafts per patient was lower in the off-pump CABG at 3.45 ± 0.75 vs 3.64 ± 0.70 in the on-pump CABG ( p  = 0.01). There was no significant difference in mortality at 3 months between the off-pump (0.63%) and on-pump groups (1.85%) with  p  value of 0.62. The cumulative combined MACCE showed significant difference between off-pump group (0.63%) and on-pump group (5.55%),  p  = 0.01. Follow-up angiograms were done in 239 (75%) patients with 120 off-pump and 119 in the on-pump group. The analysis was also done regarding graft patency in a graded manner-when analysis of A (excellent) grafts vs B (stenosed) grafts and O (occluded) grafts were made, there was no statistically significant difference in overall graft patency at 3 months between on-pump [376 /429 grafts (87.6%)] and off-pump [366 /420 grafts (87.1%)] groups ( p  = 0.82). The patency rates were similar among bypass conduits (left internal thoracic artery (ITA) in off-pump (91.4%) vs on-pump (92.9%)  p  = 0.66, right ITA in off-pump (82.1%) vs on-pump (81.8%)  p  = 0.97, radial artery in off-pump (84.4%) vs on-pump (82.6%)  p  = 0.81; saphenous vein in off-pump (85.8%) vs on-pump (86.3%),  p  = 0.86 and among 3 coronary territories.
Conclusions


Off-pump CABG is non-inferior to on-pump CABG in terms of overall graft patency at 3 months and was associated with a fewer combined cumulative MACCE compared to on-pump CABG.",2020,"Conclusions


Off-pump CABG is non-inferior to on-pump CABG in terms of overall graft patency at 3 months and was associated with a fewer combined cumulative MACCE compared to on-pump CABG.",['320 patients with multivessel coronary artery disease'],"['Coronary artery bypass grafting (CABG', 'pump CABG ( n \u2009=\u2009162) or off-pump CABG', 'pump CABG', 'pump coronary bypass surgery', 'multidetector computerized tomographic angiography or conventional coronary angiography']","['major adverse cardiac and cardiovascular events (MACCE', 'median number of grafts per patient in off-pump', 'mean number of grafts per patient', 'Graft patency', 'graft patency', 'overall graft patency', 'patency rates', 'mortality']","[{'cui': 'C4517711', 'cui_str': '320'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}]","[{'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C5191360', 'cui_str': '162'}, {'cui': 'C1449706', 'cui_str': 'Off-pump coronary artery bypass'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",320.0,0.121618,"Conclusions


Off-pump CABG is non-inferior to on-pump CABG in terms of overall graft patency at 3 months and was associated with a fewer combined cumulative MACCE compared to on-pump CABG.","[{'ForeName': 'Lokeswara Rao', 'Initials': 'LR', 'LastName': 'Sajja', 'Affiliation': 'Division of Cardiothoracic Surgery, STAR Hospitals, Road no. 10, Banjara Hills, Hyderabad, Telangana 500 034 India.'}, {'ForeName': 'Kunal', 'Initials': 'K', 'LastName': 'Sarkar', 'Affiliation': 'Division of Cardiothoracic Surgery, Medica Superspeciality Hospital, 127-Mukundapur, EM bypass, Kolkata, 700025 India.'}, {'ForeName': 'Gopichand', 'Initials': 'G', 'LastName': 'Mannam', 'Affiliation': 'Division of Cardiothoracic Surgery, STAR Hospitals, Road no. 10, Banjara Hills, Hyderabad, Telangana 500 034 India.'}, {'ForeName': 'Venkata Krishna Kumar', 'Initials': 'VKK', 'LastName': 'Kodali', 'Affiliation': 'Division of Cardiothoracic Surgery, Krishna Institute of Medical Sciences, 1-8-31/1,Minister Road, Secunderabad, Telangana 500003 India.'}, {'ForeName': 'Chandrasekar', 'Initials': 'C', 'LastName': 'Padmanabhan', 'Affiliation': 'Division of Cardiothoracic Surgery, G Kuppuswamy Naidu Memorial Hospital, Pappanaicken Palayam, Coimbatore, 641 037 India.'}, {'ForeName': 'Sanjeeth', 'Initials': 'S', 'LastName': 'Peter', 'Affiliation': 'Division of Cardiothoracic Surgery, DDMM Heart Institute, Mission Road, Nadiad, Gujarat 387002 India.'}, {'ForeName': 'Anvay', 'Initials': 'A', 'LastName': 'Mulay', 'Affiliation': 'Division of Cardiothoracic Surgery, Fortis Hospital, Multi-Specialty Hospital Mulund West, Mumbai, 400078 India.'}, {'ForeName': 'Prashanthi', 'Initials': 'P', 'LastName': 'Beri', 'Affiliation': 'Division of Clinical Research, Sajja Heart Foundation, Srinagar Colony, Hyderabad, 500073 India.'}]","Indian journal of thoracic and cardiovascular surgery : official organ, Association of Thoracic and Cardiovascular Surgeons of India",['10.1007/s12055-019-00869-0']
3480,33061158,One-year outcomes of off- and on-pump coronary artery bypass grafting: PROMOTE patency trial.,"Purpose


Earlier we reported 3-month graft patency and clinical outcomes of prospective randomized comparison of off-pump and on-pump multivessel coronary artery bypass surgery to evaluate outcomes and graft patency (PROMOTE patency) trial. We now report major adverse cardiac and cerebrovascular events (MACCE) at 1 year of patients who underwent coronary artery bypass grafting (CABG) using either off-pump technique or on-pump technique.
Methods


The PROMOTE patency trial is a two-arm, prospective, randomized, multicentre trial, and enrolled 320 patients with multivessel coronary artery disease from March 2016 through March 2017 at 6 centres and were randomly assigned to undergo either off-pump CABG (OPCAB) ( n  = 158 patients) or on-pump CABG ( n  = 162 patients). The outcomes at 1 year were assessed.
Results


One mortality (0.64%) occurred in off-pump group (at 30 days) and 4 (2.48%) in on-pump group (1 at 30 days, 2 at 3 months, and 1 at 1 year) ( p  = 0.37). There was no difference between off-pump and on-pump groups in the outcomes of nonfatal myocardial infarction (1 in off-pump and 2 in on-pump group,  p  = 1.00) and cerebrovascular accident (none in off-pump and 2 in on-pump group,  p  = 0.49). Repeat revascularization was done in one patient in each group ( p  = 1.00).
Conclusion


There was no significant difference in the incidence of MACCE between off-pump and on-pump CABG group at 1 year.",2020,"There was no difference between off-pump and on-pump groups in the outcomes of nonfatal myocardial infarction (1 in off-pump and 2 in on-pump group,  p  = 1.00) and cerebrovascular accident (none in off-pump and 2 in on-pump group,  p  = 0.49).","['patients who underwent coronary artery bypass grafting (CABG) using either off-pump technique or on-pump technique', '320 patients with multivessel coronary artery disease from March 2016 through March 2017 at 6 centres']","['pump CABG (OPCAB) ( n \u2009=\u2009158 patients) or on-pump CABG', 'pump and on-pump multivessel coronary artery bypass surgery', 'pump coronary artery bypass grafting']","['incidence of MACCE', 'Repeat revascularization', 'nonfatal myocardial infarction', 'One mortality', 'cerebrovascular accident']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C4517711', 'cui_str': '320'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]",320.0,0.117747,"There was no difference between off-pump and on-pump groups in the outcomes of nonfatal myocardial infarction (1 in off-pump and 2 in on-pump group,  p  = 1.00) and cerebrovascular accident (none in off-pump and 2 in on-pump group,  p  = 0.49).","[{'ForeName': 'Lokeswara Rao', 'Initials': 'LR', 'LastName': 'Sajja', 'Affiliation': 'Division of Cardiothoracic Surgery, Star Hospitals, Road no. 10, Banjara Hills, Hyderabad, AP 500 034 India.'}, {'ForeName': 'Kunal', 'Initials': 'K', 'LastName': 'Sarkar', 'Affiliation': 'Division of Cardiothoracic Surgery, Medica Superspeciality Hospital, 127-Mukundapur, EM Bypass, Kolkata, 700025 India.'}, {'ForeName': 'Gopichand', 'Initials': 'G', 'LastName': 'Mannam', 'Affiliation': 'Division of Cardiothoracic Surgery, Star Hospitals, Road no. 10, Banjara Hills, Hyderabad, AP 500 034 India.'}, {'ForeName': 'Venkata Krishna Kumar', 'Initials': 'VKK', 'LastName': 'Kodali', 'Affiliation': 'Division of Cardiothoracic Surgery, Krishna Institute of Medical Sciences, 1-8-31/1, Minister Road, Secunderabad, Telangana 500003 India.'}, {'ForeName': 'Chandrasekar', 'Initials': 'C', 'LastName': 'Padmanabhan', 'Affiliation': 'Division of Cardiothoracic Surgery, G Kuppuswamy Naidu Memorial Hospital, Pappanaickenpalayam, Coimbatore, 641 037 India.'}, {'ForeName': 'Sanjeeth', 'Initials': 'S', 'LastName': 'Peter', 'Affiliation': 'Division of Cardiothoracic Surgery, DDMM Heart Institute, Mission Road, Nadiad, Gujarat 387 002 India.'}, {'ForeName': 'Anvay', 'Initials': 'A', 'LastName': 'Mulay', 'Affiliation': 'Division of Cardiothoracic Surgery, Fortis Hospital, Multi-Specialty Hospital Mulund West, Mumbai, 400 078 India.'}, {'ForeName': 'Sandip', 'Initials': 'S', 'LastName': 'Sardar', 'Affiliation': 'Division of Cardiothoracic Surgery, Medica Superspeciality Hospital, 127-Mukundapur, EM Bypass, Kolkata, 700025 India.'}, {'ForeName': 'Prashanthi', 'Initials': 'P', 'LastName': 'Beri', 'Affiliation': 'Division of Clinical Research, Sajja Heart Foundation, Srinagar Colony, Hyderabad, 500 073 India.'}]","Indian journal of thoracic and cardiovascular surgery : official organ, Association of Thoracic and Cardiovascular Surgeons of India",['10.1007/s12055-020-00940-1']
3481,33061172,NOBLE trial-is it time to revise the guidelines?,"The Nordic-Baltic-British left main revascularization trial (NOBLE) is a prospective, randomized, multicentre, non-inferiority trial comparing percutaneous coronary angioplasty (PCI) with coronary artery bypass grafting (CABG) for revascularization of patients with unprotected left main coronary artery (LMCA) stenosis. The primary outcome was a combined endpoint of all-cause mortality, stroke, non-procedural myocardial infarction and repeat revascularization. CABG was found to be superior to PCI with respect to the 5-year MACCE rates (28% vs. 19%) with a hazard ratio (HR) of 1.58 (95% CI 1.24-2.01). All-cause mortality rates were similar, but PCI was associated with increased occurrence of non-procedural myocardial infarction ( p  = 0.0002) and repeat revascularization ( p  = 0.0009). There was no difference in the stroke rates ( p  = 0.11) at 5 years. Currently, European Society of Cardiology and the European Association for Cardio-Thoracic Surgery (ESC/EACTS) guidelines on myocardial revascularization assign a class 1A recommendation to PCI in patients with unprotected LMCA stenosis with a SYNTAX score < 23. The findings of the NOBLE trial challenge this premise.",2020,There was no difference in the stroke rates ( p  = 0.11) at 5 years.,"['patients with unprotected left main coronary artery (LMCA) stenosis', 'patients with unprotected LMCA stenosis with a SYNTAX score <\u200923']","['CABG', 'percutaneous coronary angioplasty (PCI', 'coronary artery bypass grafting (CABG']","['5-year MACCE rates', 'mortality rates', 'stroke rates', 'occurrence of non-procedural myocardial infarction', 'repeat revascularization', 'combined endpoint of all-cause mortality, stroke, non-procedural myocardial infarction and repeat revascularization']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}, {'cui': 'C0242231', 'cui_str': 'Coronary artery stenosis'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0002997', 'cui_str': 'Angioplasty, Coronary Balloon'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]",,0.0681095,There was no difference in the stroke rates ( p  = 0.11) at 5 years.,"[{'ForeName': 'Pradeep', 'Initials': 'P', 'LastName': 'Narayan', 'Affiliation': 'Department of Cardiac Surgery, NH Rabindranath Tagore International Institute of Cardiac Sciences (RTIICS), Kolkata, 700099 India.'}]","Indian journal of thoracic and cardiovascular surgery : official organ, Association of Thoracic and Cardiovascular Surgeons of India",['10.1007/s12055-020-00965-6']
3482,33061253,Three-Year Results of the SONATA Pivotal Trial of Transcervical Fibroid Ablation for Symptomatic Uterine Myomata.,"Objective:  This article reports on 3-year clinical outcomes of the Sonography Guided Transcervical Ablation of Uterine Fibroids (SONATA) pivotal trial of transcervical fibroid ablation (TFA) in women with symptomatic uterine myomata.  Materials and Methods:  The SONATA, prospective, controlled, multicenter interventional trial enrolled 147 premenopausal women with symptomatic uterine fibroids who underwent uterus-preserving, sonography-guided TFA with the Sonata ®  System (Gynesonics, Inc., Redwood City, CA, USA). Clinical outcomes were assessed over 3 years and included surgical reinterventions, Symptom Severity Score (SSS), and Health-Related Quality of Life (HRQoL) subscales of the Uterine Fibroid Symptom and Quality-of-Life Questionnaire, EuroQol 5-Dimension (EQ-5D) questionnaire, Overall Treatment Effect, treatment satisfaction, physical activity, work impairment, pregnancy outcomes, and adverse events.  Results:  The 3-year rates of surgical reintervention for heavy menstrual bleeding calculated by the binomial and Kaplan-Meier methods were 9.2% and 8.2%, respectively. Compared to baseline, mean SSS decreased from 55 ± 19 to 22 ± 21, HRQoL increased from 40 ± 21 to 83 ± 23, and EQ-5D increased from 0.72 ± 0.21 to 0.88 ± 0.16 (all  p  < 0.001). Treatment benefit on the SSS, HRQoL, and EQ-5Q exceeded the minimal clinically important difference at every follow-up visit over 3 years. At 3 years, 94% of the subjects reported treatment satisfaction, 88% reported reduced fibroid symptoms, work absenteeism due to fibroid symptoms decreased from 2.9% to 1.4%, and impairment due to fibroids decreased from 51% to 12% for work, and 58% to 14% for physical activity (all  p  < 0.001). No late complications occurred.  Conclusions:  Women treated with sonography-guided TFA in the SONATA pivotal trial experienced significant and durable reduction of fibroid-related symptoms, with low surgical reintervention rates over 3 years of follow-up.",2020,"Treatment benefit on the SSS, HRQoL, and EQ-5Q exceeded the minimal clinically important difference at every follow-up visit over 3 years.","['147 premenopausal women with symptomatic uterine fibroids who underwent uterus-preserving, sonography-guided TFA with the Sonata ®  System (Gynesonics, Inc., Redwood City, CA, USA', 'women with symptomatic uterine myomata']","['Transcervical Fibroid Ablation', 'sonography-guided TFA', 'Sonography Guided Transcervical Ablation of Uterine Fibroids', 'transcervical fibroid ablation (TFA']","['impairment due to fibroids', 'late complications', 'surgical reinterventions, Symptom Severity Score (SSS), and Health-Related Quality of Life (HRQoL) subscales of the Uterine Fibroid Symptom and Quality-of-Life Questionnaire, EuroQol 5-Dimension (EQ-5D) questionnaire, Overall Treatment Effect, treatment satisfaction, physical activity, work impairment, pregnancy outcomes, and adverse events', 'reduced fibroid symptoms, work absenteeism due to fibroid symptoms', '3-year rates of surgical reintervention for heavy menstrual bleeding calculated by the binomial and Kaplan-Meier methods', 'mean SSS', 'physical activity', 'EQ-5D', 'SSS, HRQoL, and EQ-5Q', 'treatment satisfaction']","[{'cui': 'C1096235', 'cui_str': 'Premenopausal symptoms'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0042133', 'cui_str': 'Leiomyoma'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0040982', 'cui_str': 'Trifluoroacetic Acid'}, {'cui': 'C0876170', 'cui_str': 'Sonata'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C1002377', 'cui_str': 'Redwood'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}]","[{'cui': 'C0442344', 'cui_str': 'Transcervical approach - uterine'}, {'cui': 'C0023267', 'cui_str': 'Leiomyofibroma'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0040982', 'cui_str': 'Trifluoroacetic Acid'}, {'cui': 'C0042133', 'cui_str': 'Leiomyoma'}]","[{'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0023267', 'cui_str': 'Leiomyofibroma'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0042133', 'cui_str': 'Leiomyoma'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0000849', 'cui_str': 'Absenteeism'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025323', 'cui_str': 'Menorrhagia'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037052', 'cui_str': 'Sick sinus syndrome'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}]",147.0,0.113088,"Treatment benefit on the SSS, HRQoL, and EQ-5Q exceeded the minimal clinically important difference at every follow-up visit over 3 years.","[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Lukes', 'Affiliation': ""Carolina Women's Research and Wellness Center, Durham, North Carolina, USA.""}, {'ForeName': 'Minda A', 'Initials': 'MA', 'LastName': 'Green', 'Affiliation': 'Virtua OB/Gyn, Voorhees, New Jersey, USA.'}]",Journal of gynecologic surgery,['10.1089/gyn.2020.0021']
3483,33061281,"Safety and Efficacy of a Preservative-Free Artificial Tear Containing Carboxymethylcellulose and Hyaluronic Acid for Dry Eye Disease: A Randomized, Controlled, Multicenter 3-Month Study.","Purpose


To compare the efficacy and safety of an artificial tear combining the polymers carboxymethylcellulose (CMC) and hyaluronic acid (HA), to a formulation of CMC alone in subjects with dry eye.
Methods


A preservative-free artificial tear (CMC-HA) was compared with an existing artificial tear (CMC). Subjects with mild-to-severe signs and symptoms of dry eye were enrolled in this double-masked, randomized, multicenter trial, and dosed at least twice daily for 90 days, with follow-up visits at Days 7, 30, 60, and 90. Ocular Surface Disease Index (OSDI) was the primary outcome measure. Secondary outcome measures were tear break-up time (TBUT), ocular surface staining, Schirmer test with anesthesia, and visual analog scale (VAS) scores of dry eye symptom severity and formulation acceptability. Safety measures included adverse events, biomicroscopy, and visual acuity.
Results


A total of 460 subjects were enrolled across 45 sites (38 in Europe; 7 in Australia), of whom 454 were randomized to receive treatment. The per-protocol (PP) population consisted of 394 subjects, 364 (92.4%) of whom completed the study. In the PP population, the mean ± SD change from baseline in OSDI score at the primary timepoint, Day 90, was -16.9±17.5 for CMC-HA and -16.0±16.1 for CMC. CMC-HA was non-inferior to CMC based upon a confidence interval method. Both treatments significantly improved ( P <0.001) OSDI, symptom VAS scores, TBUT, and ocular surface staining from baseline at all follow-up visits, with minimal differences between groups. Greater reduction of overall ocular pain/discomfort was reported in subjects using CMC-HA versus CMC ( P =0.048). Approximately 10% of subjects in each group reported treatment-related adverse events of generally mild to moderate severity.
Conclusion


The new CMC-HA formulation was effective and well tolerated, and demonstrates a greater potential for symptom relief compared with CMC. These data support implementation of this formula for the management of dry eye patients.",2020,"The new CMC-HA formulation was effective and well tolerated, and demonstrates a greater potential for symptom relief compared with CMC.","['Dry Eye Disease', 'Subjects with mild-to-severe signs and symptoms of dry eye', 'dry eye patients', 'subjects with dry eye', '394 subjects, 364 (92.4%) of whom completed the study', '460 subjects were enrolled across 45 sites (38 in Europe; 7 in Australia']","['Preservative-Free Artificial Tear Containing Carboxymethylcellulose and Hyaluronic Acid', 'CMC alone', 'existing artificial tear (CMC', 'artificial tear combining the polymers carboxymethylcellulose (CMC) and hyaluronic acid (HA', 'Methods\n\n\nA preservative-free artificial tear (CMC-HA']","['OSDI score', 'Ocular Surface Disease Index (OSDI', 'tear break-up time (TBUT), ocular surface staining, Schirmer test with anesthesia, and visual analog scale (VAS) scores of dry eye symptom severity and formulation acceptability', 'adverse events, biomicroscopy, and visual acuity', 'OSDI, symptom VAS scores, TBUT, and ocular surface staining', 'Safety and Efficacy', 'efficacy and safety', 'overall ocular pain/discomfort']","[{'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0033086', 'cui_str': 'Drug preservative'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C2608262', 'cui_str': 'Artificial Tears'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0007068', 'cui_str': 'Carboxymethylcellulose'}, {'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0032521', 'cui_str': 'Polymer'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C1557335', 'cui_str': 'Ocular surface disease'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0038128', 'cui_str': 'Stain'}, {'cui': 'C0200152', 'cui_str': ""Schirmer's test""}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0151827', 'cui_str': 'Pain in eye'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}]",460.0,0.0759466,"The new CMC-HA formulation was effective and well tolerated, and demonstrates a greater potential for symptom relief compared with CMC.","[{'ForeName': 'Pasquale', 'Initials': 'P', 'LastName': 'Aragona', 'Affiliation': 'Department of Biomedical Sciences, Università di Messina, Messina, Italy.'}, {'ForeName': 'Jose M', 'Initials': 'JM', 'LastName': 'Benítez-Del-Castillo', 'Affiliation': 'Department of Ophthalmology, Hospital Clinico de Madrid, Universidad Complutense, Madrid, Spain.'}, {'ForeName': 'Minas T', 'Initials': 'MT', 'LastName': 'Coroneo', 'Affiliation': 'M.T. Coroneo Pty. Ltd, Randwick, NSW, Australia.'}, {'ForeName': 'Subhanjan', 'Initials': 'S', 'LastName': 'Mukherji', 'Affiliation': 'Department of Ophthalmology, James Paget University Hospital, Great Yarmouth, UK.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Tan', 'Affiliation': 'Optometry and Vision Science, UNSW Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Evelien', 'Initials': 'E', 'LastName': 'Vandewalle', 'Affiliation': 'Department of Ophthalmology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Algis', 'Initials': 'A', 'LastName': 'Vingrys', 'Affiliation': 'University of Melbourne EyeCare Clinic, Carlton, VIC, Australia.'}, {'ForeName': 'Haixia', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Allergan, an AbbVie company, Irvine, CA, USA.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Carlisle-Wilcox', 'Affiliation': 'Allergan, an AbbVie company, Irvine, CA, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Vehige', 'Affiliation': 'Allergan, an AbbVie company, Irvine, CA, USA.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Simmons', 'Affiliation': 'Optometry and Vision Science, UNSW Sydney, Sydney, NSW, Australia.'}]","Clinical ophthalmology (Auckland, N.Z.)",['10.2147/OPTH.S256480']
3484,33061332,Postoperative Physical Therapy to Prevent Hospital-acquired Pneumonia in Patients Over 80 Years Undergoing Hip Fracture Surgery-A Quasi-experimental Study.,"Background


Hip fracture requiring surgical fixation is a common condition with high mortality and morbidity in the geriatric population. The patients are usually frail, and vulnerable to postoperative complications and delayed recovery. Few studies have investigated physical therapy methods to prevent hospital-acquired pneumonia (HAP) after hip fracture surgery.
Objective


To explore whether an intensified physical therapy regimen can prevent HAP and reduce hospital length of stay in patients aged 80 and older, following hip fracture surgery.
Patients and Methods


The inclusion criterion was patients aged 80 or older who had undergone hip fracture surgery at Örebro University Hospital, Sweden during eight months in 2015-2016 (the ""physical therapy group"") (n=69). The study has a quasi-experimental design with a historical control group (n=64) who had received routine physical therapy treatment. The physical therapy group received intensified postoperative physical therapy treatment, which included daily supervised early mobilization and coached deep breathing exercises with positive expiratory pressure (PEP). The patients were instructed to take deep breaths, and then exhale through the PEP-valve in three sessions of 10 deep breaths, at least four times daily. Early mobilization to a sitting position and walking was advised as soon as possible after surgery.
Results


There was a significantly lower incidence of HAP in the physical therapy group; 2/69 (3%, 95%CI: 1- 10) compared to the historical control group 13/64 (20%, 95%CI: 12-32%) ( p =0.002). Patients in the physical therapy group had a significantly shorter length of stay than the control group (10.6±4 vs 13.4±9 days,  p =0.022).
Conclusion


Intensified physical therapy treatment after hip fracture surgery may be of benefit to reduce the incidence of HAP in patients over 80 years; however, the results need to be confirmed in randomized controlled trials.",2020,"Patients in the physical therapy group had a significantly shorter length of stay than the control group (10.6±4 vs 13.4±9 days,  p =0.022).
","['Hospital-acquired Pneumonia in Patients Over 80 Years', 'patients aged 80 or older who had undergone hip fracture surgery at Örebro University Hospital, Sweden during eight months in 2015-2016 (the ""physical therapy group"") (n=69', 'group (n=64) who had received', 'patients aged 80 and older, following hip fracture surgery']","['routine physical therapy treatment', '95%CI', 'physical therapy group received intensified postoperative physical therapy treatment, which included daily supervised early mobilization and coached deep breathing exercises with positive expiratory pressure (PEP', 'historical control', 'Postoperative Physical Therapy', 'intensified physical therapy regimen']","['HAP', 'shorter length of stay']","[{'cui': 'C0949083', 'cui_str': 'Hospital acquired pneumonia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0949766', 'cui_str': 'Physical therapy procedure'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0013459', 'cui_str': 'Early Mobilization'}, {'cui': 'C0454496', 'cui_str': 'Deep breathing exercises'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0949083', 'cui_str': 'Hospital acquired pneumonia'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",,0.0212089,"Patients in the physical therapy group had a significantly shorter length of stay than the control group (10.6±4 vs 13.4±9 days,  p =0.022).
","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Ståhl', 'Affiliation': 'Department of Physiotherapy, Örebro University Hospital, Örebro, Sweden.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Westerdahl', 'Affiliation': 'University Health Care Research Center, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.'}]",Clinical interventions in aging,['10.2147/CIA.S257127']
3485,33061347,Efficacy of Unsupervised Home-Based Pulmonary Rehabilitation for Patients with Chronic Obstructive Pulmonary Disease.,"Purpose


Pulmonary rehabilitation (PR) is a well-established treatment for chronic obstructive pulmonary disease (COPD). The standard protocol for PR requires frequent hospital visits, which can be difficult for patients. We performed this study to assess whether unsupervised home-based PR (HBPR) is effective for patients with COPD.
Patients and Methods


After assessing the outcome data, including the results of a COPD assessment test (CAT); the body mass index, airflow obstruction, dyspnea, and exercise capacity (BODE) index; a spirometry; the modified Medical Research Council (mMRC) dyspnea scale; and the 6-min walking test (6MWT), specialists imparted 1-hour education to patients regarding unsupervised HBPR at the baseline visit. This included methods for breathing, inhaler use, stretching, and exercise. On reviewing diaries after 8 weeks from the first visit, patients who exercised at least thrice per week were classified as the compliant group and the others were categorized as the noncompliant group. Changes in the outcomes were compared between the compliant and noncompliant groups.
Results


A total of 41 patients were enrolled in this study; for 8 weeks of unsupervised HBPR, there were significant improvements in CAT scores (-4.62±4.61 vs 2.40±6.73;  P =0.002), BODE index (-1.00±1.06 vs -0.20±0.56;  P =0.01), and forced expiratory volume in 1 s (0.05±0.19 vs -0.09±0.16;  P =0.02) among patients in the compliant group, compared with the noncompliant group. Moreover, their CAT (16.46±7.80 vs 11.85±7.23;  P =0.03) and mMRC scores (2.54±0.76 vs 1.81±0.63;  P =0.001) improved significantly after 8 weeks, compared with those at baseline. On the other hand, patients in the noncompliant group showed no significant improvement in any of the outcomes.
Conclusion


In this study, compliant patients with unsupervised HBPR achieved favorable outcomes in 8 weeks. Thus, we recommend unsupervised HBPR for patients with COPD, even when regular hospital visits for PR are not possible.
Trial Registration


NCT03754881.",2020,"Moreover, their CAT (16.46±7.80 vs 11.85±7.23;  P =0.03) and mMRC scores (2.54±0.76 vs 1.81±0.63;  P =0.001) improved significantly after 8 weeks, compared with those at baseline.","['chronic obstructive pulmonary disease (COPD', '41 patients', 'patients with COPD', 'Patients with Chronic Obstructive Pulmonary Disease']","['Pulmonary rehabilitation (PR', 'Unsupervised Home-Based Pulmonary Rehabilitation', 'unsupervised home-based PR (HBPR']","['BODE index', 'forced expiratory volume', 'CAT scores', 'mMRC scores', 'COPD assessment test (CAT); the body mass index, airflow obstruction, dyspnea, and exercise capacity (BODE) index; a spirometry; the modified Medical Research Council (mMRC) dyspnea scale; and the 6-min walking test (6MWT), specialists imparted 1-hour education to patients regarding unsupervised HBPR']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C4284282', 'cui_str': 'COPD assessment test'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0079816', 'cui_str': 'Research, Medical'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0231999', 'cui_str': 'Airflow'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]",41.0,0.053022,"Moreover, their CAT (16.46±7.80 vs 11.85±7.23;  P =0.03) and mMRC scores (2.54±0.76 vs 1.81±0.63;  P =0.001) improved significantly after 8 weeks, compared with those at baseline.","[{'ForeName': 'Jang Ho', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Hyang Yi', 'Initials': 'HY', 'LastName': 'Lee', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Youngwon', 'Initials': 'Y', 'LastName': 'Jang', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jae Seung', 'Initials': 'JS', 'LastName': 'Lee', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Yeon-Mok', 'Initials': 'YM', 'LastName': 'Oh', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Sang-Do', 'Initials': 'SD', 'LastName': 'Lee', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Sei Won', 'Initials': 'SW', 'LastName': 'Lee', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}]",International journal of chronic obstructive pulmonary disease,['10.2147/COPD.S268683']
3486,33061349,"Clinically Important Deterioration Among Patients with Chronic Obstructive Pulmonary Disease (COPD) Treated with Nebulized Glycopyrrolate: A Post Hoc Analysis of Pooled Data from Two Randomized, Double-Blind, Placebo-Controlled Studies.","Purpose


Using a composite endpoint, pooled data from two 12-week Phase III placebo-controlled trials (GOLDEN 3, NCT02347761; GOLDEN 4, NCT02347774) were analyzed to determine whether glycopyrrolate inhalation solution (25 mcg and 50 mcg) administered twice daily (BID) via the eFlow ®  Closed System nebulizer (GLY) reduced the risk of clinically important deterioration (CID) in patients with moderate-to-very-severe COPD.
Methods


CID was defined as ≥100-mL decrease from baseline in post-bronchodilator trough forced expiratory volume in one second (FEV 1 ), or ≥4-unit increase in baseline St. George's Respiratory Questionnaire (SGRQ) total score, or moderate/severe exacerbation. The relative treatment effect of GLY versus placebo on the odds of CID (any and by component endpoints) was expressed as the odds ratio (OR) and 95% confidence interval (CI). Subgroups categorized by age (<65/≥65 years), sex, smoking status (current/former), long-acting beta agonist (LABA) use, FEV 1  (<50%/≥50%), and peak inspiratory flow rate (PIFR) (<60 L/min/≥60 L/min) were analyzed.
Results


Compared to placebo, GLY 25 mcg and 50 mcg BID over 12 weeks significantly reduced the risk of CID by 50% (OR: 0.50 [0.37-0.68]) and 40% (OR: 0.60 [0.44-0.80]), respectively. Subjects treated with GLY 25 mcg BID were 59% less likely to experience CID in FEV 1  (OR: 0.41 [0.27-0.62]) and 48% less likely to perceive CID in health status (OR: 0.52 [0.37-0.73]). Statistically significant reductions were also observed at the higher dose. The incidence of moderate/severe exacerbations was low and comparable among the cohorts. GLY 25 mcg BID was significantly more effective than placebo (p<0.05) in preventing CID irrespective of age, smoking status, LABA use, COPD severity, or PIFR. Subjects <65 years (OR 0.45 [0.29-0.68]) and those with PIFR <60 L/min (OR 0.36 [0.20-0.67]) exhibited the largest benefit.
Conclusion


Nebulized GLY over 12 weeks significantly reduced the risk of CID and provided greater short-term stability in patients with moderate-to-very-severe COPD.",2020,"GLY 25 mcg BID was significantly more effective than placebo (p<0.05) in preventing CID irrespective of age, smoking status, LABA use, COPD severity, or PIFR.","['Patients with Chronic Obstructive Pulmonary Disease (COPD) Treated with', 'Subgroups categorized by age (<65/≥65 years), sex, smoking status (current/former), long-acting beta agonist (LABA) use', 'patients with moderate-to-very-severe COPD']","['Nebulized GLY', 'glycopyrrolate inhalation solution (25 mcg and 50 mcg) administered twice daily (BID) via the eFlow ®', 'GLY versus placebo', 'Closed System nebulizer ', 'placebo', 'placebo, GLY', 'Nebulized Glycopyrrolate', 'GLY 25 mcg BID', 'Placebo']","['risk of CID', 'risk of CID and provided greater short-term stability', ""baseline St. George's Respiratory Questionnaire (SGRQ) total score, or moderate/severe exacerbation"", 'peak inspiratory flow rate (PIFR', 'incidence of moderate/severe exacerbations', 'CID irrespective of age, smoking status, LABA use, COPD severity, or PIFR', 'risk of clinically important deterioration (CID']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C3641272', 'cui_str': 'Very severe'}]","[{'cui': 'C0017890', 'cui_str': 'Glycine'}, {'cui': 'C0017970', 'cui_str': 'Glycopyrrolate'}, {'cui': 'C1154181', 'cui_str': 'Solution for inhalation'}, {'cui': 'C0439211', 'cui_str': 'mcg'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0027524', 'cui_str': 'Nebulizer'}, {'cui': 'C0048106', 'cui_str': ""4-benzamido-4'-isothiocyanostilbene-2,2'-disulfonate""}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0429742', 'cui_str': 'Peak inspiratory flow rate'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",,0.455208,"GLY 25 mcg BID was significantly more effective than placebo (p<0.05) in preventing CID irrespective of age, smoking status, LABA use, COPD severity, or PIFR.","[{'ForeName': 'Edward M', 'Initials': 'EM', 'LastName': 'Kerwin', 'Affiliation': 'Clinical Research Institute of Southern Oregon, Medford, OR, USA.'}, {'ForeName': 'Lindsey', 'Initials': 'L', 'LastName': 'Murray', 'Affiliation': 'Evidera, Bethesda, MD, USA.'}, {'ForeName': 'Xiaoli', 'Initials': 'X', 'LastName': 'Niu', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA, USA.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Dembek', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA, USA.'}]",International journal of chronic obstructive pulmonary disease,['10.2147/COPD.S267249']
3487,33061398,Effect of Switching from Low-Dose Simvastatin to High-Dose Atorvastatin on Glucose Homeostasis and Cognitive Function in Type 2 Diabetes.,"Background


High-intensity statin is recommended in high-risk type 2 diabetes (T2D); however, statin dose dependently increases the risk of developing new-onset diabetes, can potentially worsen glycemic control in T2D, and may cause cognitive impairment. This study aimed to investigate the effect of statin intensification on glucose homeostasis and cognitive function in T2D.
Materials and Methods


T2D patients who were taking simvastatin ≤20 mg/day were randomized to continue taking the same dosage of simvastatin (low-dose simvastatin group; LS, n=63) for 12 weeks, or to change to atorvastatin 40 mg/day for 6 weeks, and if tolerated, atorvastatin was increased to 80 mg/day for 6 weeks (high-dose atorvastatin group; HS, n=62). Fasting plasma glucose (FPG), glycated hemoglobin (HbA 1c ), plasma insulin, homeostatic model assessment of insulin resistance (HOMA-IR) and of β-cell function (HOMA-B), cognitive functions using Montreal Cognitive Assessment (MoCA), and Trail Making Test (TMT) were assessed at baseline, 6 weeks, and 12 weeks.
Results


Mean age of patients was 58.8±8.9 years, and 72% were female. Mean baseline FPG and HbA 1c  were 124.0±27.5 mg/dl and 6.9±0.8%, respectively. No differences in baseline characteristics between groups were observed. Change in HbA 1c  from baseline in the LS and HS groups was -0.1% and +0.1% ( p =0.03) at 6 weeks, and -0.1% and +0.1% ( p =0.07) at 12 weeks. There were no significant differences in FPG, fasting plasma insulin, HOMA-B, HOMA-IR, MoCA score, or TMT between groups at 6 or 12 weeks.
Conclusion


Switching from low-dose simvastatin to high-dose atorvastatin in T2D resulted in a slight increase in HbA 1c  (0.1%) without causing cognitive decline.",2020,"There were no significant differences in FPG, fasting plasma insulin, HOMA-B, HOMA-IR, MoCA score, or TMT between groups at 6 or 12 weeks.
","['≤20 mg/day', 'T2D.\nMaterials and Methods\n\n\nT2D patients who were taking', 'Mean age of patients was 58.8±8.9 years, and 72% were female', 'Type 2 Diabetes']","['\n\n\nHigh-intensity statin', 'simvastatin (low-dose simvastatin', 'atorvastatin', 'Switching from Low-Dose Simvastatin to High-Dose Atorvastatin', 'simvastatin', 'statin intensification']","['Change in HbA 1c', 'Glucose Homeostasis and Cognitive Function', 'Mean baseline FPG and HbA 1c', 'FPG, fasting plasma insulin, HOMA-B, HOMA-IR, MoCA score, or TMT', 'Fasting plasma glucose (FPG), glycated hemoglobin (HbA 1c ), plasma insulin, homeostatic model assessment of insulin resistance (HOMA-IR) and of β-cell function (HOMA-B), cognitive functions using Montreal Cognitive Assessment (MoCA), and Trail Making Test (TMT', 'glucose homeostasis and cognitive function']","[{'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0074554', 'cui_str': 'Simvastatin'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C0444956', 'cui_str': 'High dose'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0857690', 'cui_str': 'Plasma insulin'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C4721272', 'cui_str': 'Montreal cognitive assessment score'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0007613', 'cui_str': 'Physiology, Cell'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0040604', 'cui_str': 'Trail making test'}]",,0.0177678,"There were no significant differences in FPG, fasting plasma insulin, HOMA-B, HOMA-IR, MoCA score, or TMT between groups at 6 or 12 weeks.
","[{'ForeName': 'Nuntakorn', 'Initials': 'N', 'LastName': 'Thongtang', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Natthakan', 'Initials': 'N', 'LastName': 'Tangkittikasem', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Kittichai', 'Initials': 'K', 'LastName': 'Samaithongcharoen', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Jirasak', 'Initials': 'J', 'LastName': 'Piyapromdee', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Varalak', 'Initials': 'V', 'LastName': 'Srinonprasert', 'Affiliation': 'Division of Geriatric Medicine, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Sutin', 'Initials': 'S', 'LastName': 'Sriussadaporn', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}]",Vascular health and risk management,['10.2147/VHRM.S270751']
3488,33061414,Proteins and Amino Acids Treated with Atmospheric Plasma Show Significantly Increased Bioavailability in Humans.,"Background


Muscle mass is an important determinant of metabolic health and physical function. It has previously been demonstrated that the postprandial rise in circulating essential amino acids acts as the main stimulus for muscle protein synthesis (MPS). The current study investigated the postprandial plasma essential amino acid (EAA) and branched-chain amino acid (BCAA) responses of (1) Hydrolyzed whey protein isolate (HWPI) compared to plasma treated non-hydrolyzed whey protein isolate (PT-NHWPI), (2) standard branch-chain amino acids (S-BCAA) compared to plasma treated branch-chained amino acids (PT-BCAA), (3) standard pea protein (S-PP), compared to plasma treated pea protein (PT-PP), and (4) HWPI compared to PT-PP.
Methods


Ten subjects (24.6 ± 5.3 years; 178.8 ± 8.1 cm; 78.6 ± 10.1 kg) participated in a double-blind, randomized, crossover trial comparing four separate protein conditions (HWPI, PT-NHWPI, S-PP, PT-PP). A separate cohort of ten subjects (26.4 ± 7.4 years; 178.8 ± 5.9 cm; 85 ± 12.3 kg) participated in a double-blind randomized, crossover trial comparing two branch-chain amino acid conditions: S-BCAA and PT-BCAA. All conditions were administered following a 7-day washout. Plasma EAA and BCAA concentrations were assessed from blood donated by subjects at pre-consumption, 30-, 60-, 90-, 120-, and 180 minutes post-consumption.
Results


Blood plasma levels of total EAA and BCAA concentration were significantly greater in all treated conditions at 30-, 60-, 90-, and 120 minutes post consumption ( P  < .05). There were no differences between PT-PP and HWPI.
Discussion


All proteins significantly elevated EAAs, and BCAAs from basal levels. However, we conclude that the consumption of the treated proteins significantly raises blood levels of EAAs, and BCAAs to a greater extent across multiple dairy, vegan, and isolated BCAA conditions. Moreover, atmospheric plasma treatment of a vegan protein source makes its amino acid response similar to whey. Thus, protein supplementation with that has undergone Ingredient Optimized® atmospheric plasma treatment technology may be highly beneficial for improving the blood plasma amino acid response.",2020,"Results


Blood plasma levels of total EAA and BCAA concentration were significantly greater in all treated conditions at 30-, 60-, 90-, and 120 minutes post consumption ( P  < .05).","['A separate cohort of ten subjects (26.4\u2009±\u20097.4\u2009years; 178.8\u2009±\u20095.9\u2009cm; 85\u2009±\u200912.3\u2009kg', 'Methods\n\n\nTen subjects (24.6\u2009±\u20095.3\u2009years; 178.8\u2009±\u20098.1\u2009cm; 78.6\u2009±\u200910.1\u2009kg']",['branch-chain amino acid conditions: S-BCAA and PT-BCAA'],"['blood plasma amino acid response', 'Bioavailability', 'elevated EAAs, and BCAAs from basal levels', 'Blood plasma levels of total EAA and BCAA concentration', 'Plasma EAA and BCAA concentrations', 'postprandial plasma essential amino acid (EAA) and branched-chain amino acid (BCAA) responses', 'blood levels of EAAs, and BCAAs']","[{'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C4517858', 'cui_str': '7.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C5191283', 'cui_str': '12.3'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4708663', 'cui_str': '5.3'}, {'cui': 'C4517875', 'cui_str': '8.1'}]","[{'cui': 'C0002521', 'cui_str': 'Branched-chain amino acid'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0002520', 'cui_str': 'amino acids'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0002525', 'cui_str': 'Essential amino acid'}, {'cui': 'C0002521', 'cui_str': 'Branched-chain amino acid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0005767', 'cui_str': 'Blood'}]",,0.0458029,"Results


Blood plasma levels of total EAA and BCAA concentration were significantly greater in all treated conditions at 30-, 60-, 90-, and 120 minutes post consumption ( P  < .05).","[{'ForeName': 'Matthew H', 'Initials': 'MH', 'LastName': 'Sharp', 'Affiliation': 'The Applied Science & Performance Institute, Tampa, FL, USA.'}, {'ForeName': 'Matthew W', 'Initials': 'MW', 'LastName': 'Stefan', 'Affiliation': 'The Applied Science & Performance Institute, Tampa, FL, USA.'}, {'ForeName': 'Raad H', 'Initials': 'RH', 'LastName': 'Gheith', 'Affiliation': 'The Applied Science & Performance Institute, Tampa, FL, USA.'}, {'ForeName': 'Dallen D', 'Initials': 'DD', 'LastName': 'Reber', 'Affiliation': 'The Applied Science & Performance Institute, Tampa, FL, USA.'}, {'ForeName': 'Charlie R', 'Initials': 'CR', 'LastName': 'Ottinger', 'Affiliation': 'The Applied Science & Performance Institute, Tampa, FL, USA.'}, {'ForeName': 'Jacob M', 'Initials': 'JM', 'LastName': 'Wilson', 'Affiliation': 'The Applied Science & Performance Institute, Tampa, FL, USA.'}, {'ForeName': 'Ryan P', 'Initials': 'RP', 'LastName': 'Lowery', 'Affiliation': 'The Applied Science & Performance Institute, Tampa, FL, USA.'}]",Nutrition and metabolic insights,['10.1177/1178638820949239']
3489,33061494,Mediterranean Diet and Naltrexone/Bupropion Treatment for Weight Loss in Overweight and Obese Breast Cancer Survivors and Non-Cancer Participants: A Pilot Randomized Controlled Trial.,"Introduction


The objective of this pilot randomized controlled trial was to investigate the combined effect of a Mediterranean diet and naltrexone/bupropion treatment on body weight, metabolic parameters, and quality of life in overweight or obese breast cancer survivors.
Methods


Forty-four breast cancer survivors were randomly assigned to receive the Mediterranean diet plus naltrexone/bupropion medication (breast cancer survivor MeDiet+NB group) or the Mediterranean diet alone (breast cancer survivor MeDiet-only group). Twenty-eight age-matched non-cancer patients were instructed to consume the Mediterranean diet plus naltrexone/bupropion medication (non-cancer MeDiet+NB group). After the 8-week intervention, changes in body weight, metabolic parameters, nutrient intake, and quality of life of the three groups were assessed.
Results


Significant weight loss of 2.8 kg was noted for the breast cancer survivor MeDiet+NB group, 1.8 kg for the breast cancer survivor MeDiet-only group, and 2.5 kg for the non-cancer MeDiet+NB group after 8 weeks ( P  < 0.05 versus baseline by Wilcoxon's signed-rank test). All three groups also exhibited significantly lower fasting glucose, insulin, and homeostasis model assessment of insulin resistance levels ( P  < 0.05). Quality of life as assessed by self-reported questionnaires showed improvement in all participants ( P  < 0.05). However, there were no significant differences of changes in body weights, metabolic parameters, and quality of life among the three groups or between the MeDiet+NB and MeDiet-only groups.
Conclusion


We found that the Mediterranean diet, with or without naltrexone/bupropion treatment, facilitates weight loss, improves metabolic parameters, and increases quality of life. The combination of the Mediterranean diet with naltrexone/bupropion treatment did not produce superior changes when compared to the Mediterranean diet alone.
Trial Registration


This trial was retrospectively registered on 10 July 2018 as NCT03581630 at ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT03581630).",2020,Quality of life as assessed by self-reported questionnaires showed improvement in all participants ( P  < 0.05).,"['overweight or obese breast cancer survivors', 'Overweight and Obese Breast Cancer Survivors and Non-Cancer Participants', 'Twenty-eight age-matched non-cancer patients', 'Methods\n\n\nForty-four breast cancer survivors']","['Mediterranean Diet and Naltrexone/Bupropion', 'Mediterranean diet plus naltrexone/bupropion medication', 'Mediterranean diet plus naltrexone/bupropion medication (breast cancer survivor MeDiet+NB group) or the Mediterranean diet alone (breast cancer survivor MeDiet-only group', 'Mediterranean diet and naltrexone/bupropion', 'naltrexone/bupropion']","['weight loss', 'body weight, metabolic parameters, and quality of life', 'fasting glucose, insulin, and homeostasis model assessment of insulin resistance levels', 'body weight, metabolic parameters, nutrient intake, and quality of life', 'weight loss, improves metabolic parameters', 'Weight Loss', 'Quality of life', 'body weights, metabolic parameters, and quality of life', 'quality of life']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319568', 'cui_str': '44'}]","[{'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C0085208', 'cui_str': 'Bupropion'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C1829779', 'cui_str': 'Homeostasis model assessment'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",44.0,0.0212643,Quality of life as assessed by self-reported questionnaires showed improvement in all participants ( P  < 0.05).,"[{'ForeName': 'A-Ra', 'Initials': 'AR', 'LastName': 'Cho', 'Affiliation': 'Department of Family Medicine, Yong-in Severance Hospital, Yonsei University College of Medicine, Yong‑in 16995, Republic of Korea.'}, {'ForeName': 'Won-Jun', 'Initials': 'WJ', 'LastName': 'Choi', 'Affiliation': 'Department of Medicine, Graduate School, Yonsei University, Seoul 03722, Republic of Korea.'}, {'ForeName': 'Yu-Jin', 'Initials': 'YJ', 'LastName': 'Kwon', 'Affiliation': 'Department of Family Medicine, Yong-in Severance Hospital, Yonsei University College of Medicine, Yong‑in 16995, Republic of Korea.'}, {'ForeName': 'Hye Sun', 'Initials': 'HS', 'LastName': 'Lee', 'Affiliation': 'Biostatistics Collaboration Unit, Department of Research Affairs, Yonsei University College of Medicine, Seoul 06273, Republic of Korea.'}, {'ForeName': 'Sung Gwe', 'Initials': 'SG', 'LastName': 'Ahn', 'Affiliation': 'Department of Surgery, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul 06273, Republic of Korea.'}, {'ForeName': 'Ji-Won', 'Initials': 'JW', 'LastName': 'Lee', 'Affiliation': 'Department of Family Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul 06273, Republic of Korea.'}]","Diabetes, metabolic syndrome and obesity : targets and therapy",['10.2147/DMSO.S269237']
3490,33061500,Effect of Anthocyanins Supplementation on Serum IGFBP-4 Fragments and Glycemic Control in Patients with Fasting Hyperglycemia: A Randomized Controlled Trial.,"Background


Insulin-like growth factor binding protein-4 (IGFBP-4) fragments have been shown to be associated with cardiometabolic diseases. Anthocyanins as a subgroup of natural polyphenols could have benefits on treating cardiometabolic diseases. The aim of this study was to examine the effects of purified anthocyanins on serum IGFBP-4 fragments and glycemic control in patients with fasting hyperglycemia.
Methods


A set of 121 participants with elevated fasting glucose (≥5.6 mmol/L), who were originally randomly assigned to anthocyanins (320 mg/day) or placebo groups, were included in this study. Serum IGFBP-4 fragments, fasting and postload glucose, insulin, and C-peptide after a three-hour oral glucose tolerance test (OGTT) were measured at baseline and at the end of 12 weeks.
Results


Compared with placebo, anthocyanins increased serum IGFBP-4 fragments (net change 8.33 ng/mL, 95% CI [1.2, 15.47],  p =0.023) and decreased fasting glucose (-0.4 mmol/L [-0.71, -0.1],  p =0.01), 2-hour C-peptide (-1.02 ng/mL [-1.99, -0.04],  p =0.041) and the 3-hour area under the curve (AUC) of C-peptide (-2.19 [-4.11, -0.27],  p =0.026). No other significant difference in parameters for glycemic control and insulin resistance was observed.
Conclusion


Anthocyanins supplementation for 12 weeks improved serum IGFBP-4 fragments and decreased fasting glucose and postload C-peptide in patients with fasting hyperglycemia. Further studies are needed to confirm our findings and clarify the potential mechanism.
Trial Registration


ClinicalTrials.gov, NCT02689765. Registered on 6 February 2016, https://clinicaltrials.gov/ct2/show/NCT02689765.",2020,"Compared with placebo, anthocyanins increased serum IGFBP-4 fragments (net change 8.33 ng/mL, 95% CI [1.2, 15.47],  p =0.023) and decreased fasting glucose (-0.4 mmol/L [-0.71, -0.1],  p =0.01), 2-hour C-peptide","['Patients with Fasting Hyperglycemia', 'patients with fasting hyperglycemia', '121 participants with elevated fasting glucose (≥5.6 mmol/L']","['purified anthocyanins', 'anthocyanins', 'Anthocyanins', 'Anthocyanins supplementation', 'placebo', 'placebo, anthocyanins', 'Anthocyanins Supplementation']","['3-hour area under the curve (AUC) of C-peptide', 'Serum IGFBP-4 Fragments and Glycemic Control', 'serum IGFBP-4 fragments and decreased fasting glucose and postload C-peptide', 'Serum IGFBP-4 fragments, fasting and postload glucose, insulin, and C-peptide after a three-hour oral glucose tolerance test (OGTT', 'serum IGFBP-4 fragments and glycemic control', 'glycemic control and insulin resistance', 'fasting glucose', 'serum IGFBP-4 fragments']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2609269', 'cui_str': 'Fasting hyperglycaemia'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}]","[{'cui': 'C0003161', 'cui_str': 'Anthocyanin'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0006558', 'cui_str': 'C-peptide'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0018284', 'cui_str': 'Growth factor'}, {'cui': 'C0242210', 'cui_str': 'Binding protein'}, {'cui': 'C0332255', 'cui_str': 'Fragment of'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}]",,0.197139,"Compared with placebo, anthocyanins increased serum IGFBP-4 fragments (net change 8.33 ng/mL, 95% CI [1.2, 15.47],  p =0.023) and decreased fasting glucose (-0.4 mmol/L [-0.71, -0.1],  p =0.01), 2-hour C-peptide","[{'ForeName': 'Liping', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': ""Center for Chronic Disease Control, Nanshan, Shenzhen, People's Republic of China.""}, {'ForeName': 'Zhaomin', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': ""Guangdong Provincial Key Laboratory of Food, Nutrition and Health, Department of Nutrition, School of Public Health, Sun Yat-sen University, Guangzhou, People's Republic of China.""}, {'ForeName': 'Wenhua', 'Initials': 'W', 'LastName': 'Ling', 'Affiliation': ""Guangdong Provincial Key Laboratory of Food, Nutrition and Health, Department of Nutrition, School of Public Health, Sun Yat-sen University, Guangzhou, People's Republic of China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': ""Center for Chronic Disease Control, Nanshan, Shenzhen, People's Republic of China.""}, {'ForeName': 'Changyi', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': ""Center for Chronic Disease Control, Nanshan, Shenzhen, People's Republic of China.""}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': ""Center for Chronic Disease Control, Nanshan, Shenzhen, People's Republic of China.""}, {'ForeName': 'Xiaolin', 'Initials': 'X', 'LastName': 'Peng', 'Affiliation': ""Center for Chronic Disease Control, Nanshan, Shenzhen, People's Republic of China.""}, {'ForeName': 'Jianying', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': ""Internal Medicine Department, BaiYun Hospital, GuangZhou, GuangDong Province, People's Republic of China.""}]","Diabetes, metabolic syndrome and obesity : targets and therapy",['10.2147/DMSO.S266751']
3491,33061515,The Effectiveness of Right- vs Left-lateral Starting Position in Unsedated Diagnostic Colonoscopy with Modified-water Immersion Method: A Randomized Controlled Trial Study.,"Objective


A colonoscopy study in sedated patients with air insufflation showed that right-lateral starting position (RLP) improved abdominal discomfort and reduced cecal intubation time. The aim of this study was to determine if RLP vs left-lateral starting position (LLP) may produce similar results in unsedated patients examined with a modified-water immersion (m-WI) method.
Methods


Consecutive patients for diagnostic colonoscopy meeting the inclusion criteria were randomized. Patients and colonoscopist were unblinded. The m-WI method entailed suction during insertion not only for fecal debris evacuation but also to facilitate passage through difficult or angulated colonic flexures. Water was infused as needed when any difficulty was encountered during insertion. A bowel visualization scale (BVS) (0=totally blurred visualization; 1=blurred lumen visualization; 2=small fecal debris with clear mucosa visualization; 3= clear visualization) was used to evaluate the interference of fecal debris with cecal intubation rate and time.
Results


A total of 142 patients (72 in RLP and 70 in LLP) were enrolled. The respective pain score, visual analog scale, (VAS) and cecal intubation rate were not significantly different. The cecal intubation time was nearly significantly different (13.4±4.5 min vs 11.7±5.4 min;  p =0.054) and was significantly different in the constipation subgroup (16.0±3.5 min vs 8.6±3.8 min;  p =0.001). The cecal intubation time based on BVS showed significant difference between RLP and LLP in Scale 2 (13.9±4.6 min vs 10.3±4.2 min;  p =0.003) and Scale 2 and 3 combined (13.2±4.3 min vs 10.6±4.8 min;  p =0.01), respectively.
Conclusion


RLP did not improve the pain score, and LLP showed better performance in unsedated m-WI colonoscopy patients (ClinicalTrial.gov, NCT03489824).",2020,"The respective pain score, visual analog scale, (VAS) and cecal intubation rate were not significantly different.","['sedated patients with air insufflation', 'unsedated patients examined with a modified-water immersion (m-WI) method', 'Unsedated Diagnostic Colonoscopy with Modified-water Immersion Method', '142 patients (72 in RLP and 70 in LLP) were enrolled']","['RLP vs left-lateral starting position (LLP', 'Right- vs Left-lateral Starting Position', 'right-lateral starting position (RLP', 'RLP']","['respective pain score, visual analog scale, (VAS) and cecal intubation rate', 'interference of fecal debris with cecal intubation rate and time', 'cecal intubation time', 'abdominal discomfort and reduced cecal intubation time', 'bowel visualization scale (BVS', 'pain score']","[{'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0021634', 'cui_str': 'Insufflation'}, {'cui': 'C0420616', 'cui_str': 'Patient examined'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0020940', 'cui_str': 'Immersion'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0400018', 'cui_str': 'Diagnostic endoscopic examination on colon'}, {'cui': 'C0450415', 'cui_str': 'Lateral to the right'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}]","[{'cui': 'C0450415', 'cui_str': 'Lateral to the right'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0450414', 'cui_str': 'Lateral to the left'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0205090', 'cui_str': 'Right'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0007531', 'cui_str': 'Cecum structure'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0440266', 'cui_str': 'Debris'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0232487', 'cui_str': 'Abdominal discomfort'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",142.0,0.103904,"The respective pain score, visual analog scale, (VAS) and cecal intubation rate were not significantly different.","[{'ForeName': 'Putut', 'Initials': 'P', 'LastName': 'Bayupurnama', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Faculty of Medicine, Universitas Gadjah Mada/Dr Sardjito General Hospital, Yogyakarta, Indonesia.'}, {'ForeName': 'Neneng', 'Initials': 'N', 'LastName': 'Ratnasari', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Faculty of Medicine, Universitas Gadjah Mada/Dr Sardjito General Hospital, Yogyakarta, Indonesia.'}, {'ForeName': 'Fahmi', 'Initials': 'F', 'LastName': 'Indrarti', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Faculty of Medicine, Universitas Gadjah Mada/Dr Sardjito General Hospital, Yogyakarta, Indonesia.'}, {'ForeName': 'Catharina', 'Initials': 'C', 'LastName': 'Triwikatmani', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Faculty of Medicine, Universitas Gadjah Mada/Dr Sardjito General Hospital, Yogyakarta, Indonesia.'}, {'ForeName': 'Sutanto', 'Initials': 'S', 'LastName': 'Maduseno', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Faculty of Medicine, Universitas Gadjah Mada/Dr Sardjito General Hospital, Yogyakarta, Indonesia.'}, {'ForeName': 'Siti', 'Initials': 'S', 'LastName': 'Nurdjanah', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Faculty of Medicine, Universitas Gadjah Mada/Dr Sardjito General Hospital, Yogyakarta, Indonesia.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'W Leung', 'Affiliation': 'Sepulveda Ambulatory Care Center, VAGLAHS and David Geffen School of Medicine at UCLA, Los Angeles, CA, USA.'}]",Clinical and experimental gastroenterology,['10.2147/CEG.S270793']
3492,33061546,Hyperalgesia and Reduced Offset Analgesia During Spinal Anesthesia.,"Introduction


Spinal anesthesia induces short-term deafferentation and causes connectivity changes in brain areas involved in endogenous pain modulation. We determined whether spinal anesthesia alters pain sensitivity and offset analgesia. Offset analgesia is a manifestation of endogenous pain modulation and characterized by profound analgesia upon a small decrease in noxious stimulation.
Methods


In this randomized controlled crossover trial, static thermal pain responses and offset analgesia were obtained in 22 healthy male volunteers during spinal anesthesia and control conditions (absence of spinal anesthesia). Pain responses and offset analgesia were measured on a remote skin area above the upper level of anesthesia (C8/Th1).
Results


Following spinal injection of the local anesthetic, the average maximum anesthesia level was Th6. Static pain scores at C8/Th1 were higher during spinal anesthesia compared to control: 59.1 ± 15.0 mm (spinal anesthesia) versus 51.7 ± 19.7 mm (control; p = 0.03). Offset analgesia responses were decreased during spinal analgesia: pain score decrease 79 ± 27% (spinal anesthesia) versus 90 ± 17% (control; p = 0.016).
Discussion


We confirmed that spinal anesthesia-induced deafferentation causes hyperalgesic responses to noxious thermal stimulation and reduced offset analgesia at dermatomes remote and above the level of deafferentation. While these data suggest that the reduction of offset analgesia has a central origin, related to alterations in brain areas involved in inhibitory pain control, we cannot exclude alternative (peripheral) mechanisms.
Trial Registration


Dutch Cochrane Center under identifier (www.trialregister.nl) NL3874.",2020,Static pain scores at C8/Th1 were higher during spinal anesthesia compared to control: 59.1 ± 15.0 mm (spinal anesthesia) versus 51.7 ± 19.7 mm (control; p = 0.03).,['22 healthy male volunteers during spinal anesthesia and control conditions (absence of spinal anesthesia'],['spinal anesthesia'],"['pain sensitivity and offset analgesia', 'Offset analgesia responses', 'Hyperalgesia and Reduced Offset Analgesia', 'Static pain scores', 'Pain responses and offset analgesia']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0332197', 'cui_str': 'Absent'}]","[{'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}]","[{'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0020429', 'cui_str': 'Hyperalgesia'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0424543', 'cui_str': 'Response to pain'}]",22.0,0.02923,Static pain scores at C8/Th1 were higher during spinal anesthesia compared to control: 59.1 ± 15.0 mm (spinal anesthesia) versus 51.7 ± 19.7 mm (control; p = 0.03).,"[{'ForeName': 'Elske', 'Initials': 'E', 'LastName': 'Sitsen', 'Affiliation': 'Department of Anesthesiology, Leiden University Medical Center, Leiden, RC 2300, the Netherlands.'}, {'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'van Velzen', 'Affiliation': 'Department of Anesthesiology, Leiden University Medical Center, Leiden, RC 2300, the Netherlands.'}, {'ForeName': 'Mischa', 'Initials': 'M', 'LastName': 'de Rover', 'Affiliation': 'Department of Anesthesiology, Leiden University Medical Center, Leiden, RC 2300, the Netherlands.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Dahan', 'Affiliation': 'Department of Anesthesiology, Leiden University Medical Center, Leiden, RC 2300, the Netherlands.'}, {'ForeName': 'Marieke', 'Initials': 'M', 'LastName': 'Niesters', 'Affiliation': 'Department of Anesthesiology, Leiden University Medical Center, Leiden, RC 2300, the Netherlands.'}]",Journal of pain research,['10.2147/JPR.S258533']
3493,33054727,"Efficacy and safety of early ultrafiltration in patients with acute decompensated heart failure with volume overload: a prospective, randomized, controlled clinical trial.","BACKGROUND


Ultrafiltration decreases total body water and improves the alveolar to arterial oxygen gradient. The aims of the study were to investigate the efficacy and safety of early ultrafiltration in acute decompensated heart failure (ADHF) patients.
METHODS


100 patients with ADHF within 24 h of admission were randomly assigned into early ultrafiltration (n = 40) or torasemide plus tolvaptan (n = 60) groups. The primary outcomes were weight loss and an increase in urine output on days 4 and 8 of treatment.
RESULTS


Patients who received early ultrafiltration for 3 days achieved a greater weight loss (kg) (- 2.94 ± 3.76 vs - 0.64 ± 0.91, P < 0.001) and urine increase (mL) (198.00 ± 170.70 vs 61.77 ± 4.67, P < 0.001) than the torasemide plus tolvaptan group on day 4. From days 4 to 7, patients in the early ultrafiltration group received sequential therapy of torasemide and tolvaptan. Better control of volume was reflected in a greater weight loss (- 3.72 ± 3.81 vs - 1.34 ± 1.32, P < 0.001) and urine increase (373.80 ± 120.90 vs 79.5 ± 52.35, P < 0.001), greater reduction of B-type natriuretic peptide (BNP) (pg/mL) (- 1144 ± 1435 vs - 654.02 ± 889.65, P = 0.037), NYHA (New York Heart Association) functional class (- 1.45 ± 0.50 vs - 1.17 ± 0.62, P = 0.018), jugular venous pulse (JVP) score (points) (- 1.9 ± 1.13 vs - 0.78 ± 0.69, P < 0.001), inferior vena cava (IVC) diameter (mm) (- 15.35 ± 11.03 vs - 4.98 ± 6.00, P < 0.001) and an increase in the dyspnea score (points) (4.08 ± 3.44 vs 2.77 ± 2.03, P = 0.035) in the early ultrafiltration group on day 8. No significant differences were found in the readmission and mortality rates in the 2 patient groups at the 1-month and 3-month follow-ups. Both groups had a similar stable renal profile.
CONCLUSION


Early ultrafiltration is superior to diuretics for volume overload treatment initiation of ADHF patients. Trial registration Chinese Clinical Trial Registry, ChiCTR2000030696, Registered 10 March 2020-Retrospectively registered, https://www.chictr.org.cn/showproj.aspx?proj=29099 .",2020,No significant differences were found in the readmission and mortality rates in the 2 patient groups at the 1-month and 3-month follow-ups.,"['100 patients with ADHF within 24\xa0h of admission', 'acute decompensated heart failure (ADHF) patients', 'ADHF patients', 'patients with acute decompensated heart failure with volume overload']","['torasemide plus tolvaptan', 'sequential therapy of torasemide and tolvaptan', 'early ultrafiltration']","['weight loss', 'weight loss and an increase in urine output on days 4 and 8 of treatment', 'readmission and mortality rates', 'efficacy and safety', 'jugular venous pulse (JVP) score (points', 'stable renal profile', 'Efficacy and safety', 'greater weight loss', 'urine increase', 'inferior vena cava (IVC) diameter', 'reduction of B-type natriuretic peptide (BNP) (pg/mL', 'dyspnea score']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0546817', 'cui_str': 'Hypervolemia'}]","[{'cui': 'C0076840', 'cui_str': 'torsemide'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1176308', 'cui_str': 'tolvaptan'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0041612', 'cui_str': 'Ultrafiltration'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0232856', 'cui_str': 'Rate of urine output, function'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0232133', 'cui_str': 'Jugular venous pulse'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0278356', 'cui_str': 'Kidney panel'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0042458', 'cui_str': 'Inferior vena cava structure'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0439297', 'cui_str': 'ng/L'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}]",100.0,0.164777,No significant differences were found in the readmission and mortality rates in the 2 patient groups at the 1-month and 3-month follow-ups.,"[{'ForeName': 'Jingyi', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': 'Department of Critical Care Medicine (Specialty of Heart Failure), Tongren Hospital, Shanghai Jiaotong University School of Medicine, No. 1111 Xianxia Road, Shanghai, 200336, China.'}, {'ForeName': 'Qianli', 'Initials': 'Q', 'LastName': 'Wan', 'Affiliation': 'Department of Critical Care Medicine (Specialty of Heart Failure), Tongren Hospital, Shanghai Jiaotong University School of Medicine, No. 1111 Xianxia Road, Shanghai, 200336, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Critical Care Medicine (Specialty of Heart Failure), Tongren Hospital, Shanghai Jiaotong University School of Medicine, No. 1111 Xianxia Road, Shanghai, 200336, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Department of Cardiology, Tongren Hospital, Shanghai Jiaotong University School of Medicine, No. 1111 Xianxia Road, Shanghai, 200336, China.'}, {'ForeName': 'Miaomiao', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Department of Critical Care Medicine (Specialty of Heart Failure), Tongren Hospital, Shanghai Jiaotong University School of Medicine, No. 1111 Xianxia Road, Shanghai, 200336, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Jiang', 'Affiliation': 'Department of Cardiology, Tongren Hospital, Shanghai Jiaotong University School of Medicine, No. 1111 Xianxia Road, Shanghai, 200336, China. jiangli@shtrhospital.com.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Yuan', 'Affiliation': 'Department of Critical Care Medicine (Specialty of Heart Failure), Tongren Hospital, Shanghai Jiaotong University School of Medicine, No. 1111 Xianxia Road, Shanghai, 200336, China. yfangBM@163.com.'}]",BMC cardiovascular disorders,['10.1186/s12872-020-01733-5']
3494,33054737,Schema therapy versus cognitive behavioral therapy versus individual supportive therapy for depression in an inpatient and day clinic setting: study protocol of the OPTIMA-RCT.,"BACKGROUND


Major depressive disorder represents (MDD) a major cause of disability and disease burden. Beside antidepressant medication, psychotherapy is a key approach of treatment. Schema therapy has been shown to be effective in the treatment of psychiatric disorders, especially personality disorders, in a variety of settings and patient groups. Nevertheless, there is no evidence on its effectiveness for MDD in an inpatient nor day clinic setting and little is known about the factors that drive treatment response in such a target group.
METHODS


In the current protocol, we outline OPTIMA (OPtimized Treatment Identification at the MAx Planck Institute): a single-center randomized controlled trial of schema therapy as a treatment approach for MDD in an inpatient and day clinic setting. Over the course of 7 weeks, we compare schema therapy with cognitive behavioral therapy and individual supportive therapy, conducted in individual and group sessions and with no restrictions regarding concurrent antidepressant medication, thus approximating real-life treatment conditions. N = 300 depressed patients are included. All study therapists undergo a specific training and supervision and therapy adherence is assessed. Primary outcome is depressive symptom severity as self-assessment (Beck Depression Inventory-II) and secondary outcomes are clinical ratings of MDD (Montgomery-Asberg Depression Rating Scale), recovery rates after 7 weeks according to the Munich-Composite International Diagnostic Interview, general psychopathology (Brief Symptom Inventory), global functioning (World Health Organization Disability Assessment Schedule), and clinical parameters such as dropout rates. Further parameters on a behavioral, cognitive, psychophysiological, and biological level are measured before, during and after treatment and in 2 follow-up assessments after 6 and 24 months after end of treatment.
DISCUSSION


To our knowledge, the OPTIMA-Trial is the first to investigate the effectiveness of schema therapy as a treatment approach of MDD, to investigate mechanisms of change, and explore predictors of treatment response in an inpatient and day clinic setting by using such a wide range of parameters. Insights from OPTIMA will allow more integrative approaches of psychotherapy of MDD. Especially, the identification of intervention-specific markers of treatment response can improve evidence-based clinical decision for individualizing treatment.
TRIAL REGISTRATION


Identifier on clinicaltrials.gov : NCT03287362 ; September, 12, 2017.",2020,"Schema therapy has been shown to be effective in the treatment of psychiatric disorders, especially personality disorders, in a variety of settings and patient groups.",['N\u2009=\u2009300 depressed patients are included'],"['cognitive behavioral therapy and individual supportive therapy, conducted in individual and group sessions and with no restrictions regarding concurrent antidepressant medication', 'Schema therapy versus cognitive behavioral therapy versus individual supportive therapy']","['behavioral, cognitive, psychophysiological, and biological level', 'depressive symptom severity as self-assessment (Beck Depression Inventory-II) and secondary outcomes are clinical ratings of MDD (Montgomery-Asberg Depression Rating Scale), recovery rates after 7 weeks according to the Munich-Composite International Diagnostic Interview, general psychopathology (Brief Symptom Inventory), global functioning (World Health Organization Disability Assessment Schedule), and clinical parameters such as dropout rates']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0344211', 'cui_str': 'Support'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C5200813', 'cui_str': 'Schema Therapy'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0036591', 'cui_str': 'Self Assessment'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0451085', 'cui_str': 'Composite international diagnostic interview'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0451124', 'cui_str': 'Disability assessment schedule'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",300.0,0.0259604,"Schema therapy has been shown to be effective in the treatment of psychiatric disorders, especially personality disorders, in a variety of settings and patient groups.","[{'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Kopf-Beck', 'Affiliation': 'Max Planck Institute of Psychiatry, Kraepelinstraße 2-10, 80804, Munich, Germany. kopf-beck@psych.mpg.de.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Zimmermann', 'Affiliation': 'Max Planck Institute of Psychiatry, Kraepelinstraße 2-10, 80804, Munich, Germany.'}, {'ForeName': 'Samy', 'Initials': 'S', 'LastName': 'Egli', 'Affiliation': 'Max Planck Institute of Psychiatry, Kraepelinstraße 2-10, 80804, Munich, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Rein', 'Affiliation': 'Max Planck Institute of Psychiatry, Kraepelinstraße 2-10, 80804, Munich, Germany.'}, {'ForeName': 'Nils', 'Initials': 'N', 'LastName': 'Kappelmann', 'Affiliation': 'Max Planck Institute of Psychiatry, Kraepelinstraße 2-10, 80804, Munich, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Fietz', 'Affiliation': 'Max Planck Institute of Psychiatry, Kraepelinstraße 2-10, 80804, Munich, Germany.'}, {'ForeName': 'Jeanette', 'Initials': 'J', 'LastName': 'Tamm', 'Affiliation': 'Max Planck Institute of Psychiatry, Kraepelinstraße 2-10, 80804, Munich, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Rek', 'Affiliation': 'Max Planck Institute of Psychiatry, Kraepelinstraße 2-10, 80804, Munich, Germany.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Lucae', 'Affiliation': 'Max Planck Institute of Psychiatry, Kraepelinstraße 2-10, 80804, Munich, Germany.'}, {'ForeName': 'Anna-Katharine', 'Initials': 'AK', 'LastName': 'Brem', 'Affiliation': 'Max Planck Institute of Psychiatry, Kraepelinstraße 2-10, 80804, Munich, Germany.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Sämann', 'Affiliation': 'Max Planck Institute of Psychiatry, Kraepelinstraße 2-10, 80804, Munich, Germany.'}, {'ForeName': 'Leonhard', 'Initials': 'L', 'LastName': 'Schilbach', 'Affiliation': 'Max Planck Institute of Psychiatry, Kraepelinstraße 2-10, 80804, Munich, Germany.'}, {'ForeName': 'Martin E', 'Initials': 'ME', 'LastName': 'Keck', 'Affiliation': 'Max Planck Institute of Psychiatry, Kraepelinstraße 2-10, 80804, Munich, Germany.'}]",BMC psychiatry,['10.1186/s12888-020-02880-x']
3495,33054742,Impact evaluation of scripted lesson plans for HIV-related content in a life orientation curriculum: results from two provinces in South Africa.,"BACKGROUND


Young people under age 25 years are a key population at risk of unintended pregnancies, HIV and other sexually transmitted infections. School-based programming, focusing on youth under 17 years is strategic given that many in this age group are in school or are required to be in school and spend a considerable amount of their time at school. Prior evaluations of school-based HIV prevention programs for young people often employed weak study designs or lacked biomarkers (e.g., HIV or STI testing) to inform outcomes.
METHODS


This study used longitudinal data collected in 2016 from a cohort of grade-8 girls from Mpumalanga and KwaZulu-Natal Provinces in South Africa. We followed them for 2 years to examine the impact of the South African Department of Basic Education's revised scripted lesson plans for the HIV and sexual content of a ""life orientation"" curriculum on knowledge, attitudes, condom use behaviors, pregnancy incidence, and genital herpes incidence. Schools were randomized to intervention and control arms. Multivariable analyses were undertaken using hazard modeling for incidence-based outcomes (genital herpes and pregnancy) and generalized linear latent and mixed modeling for outcomes measured at each time period (knowledge, attitudes, and condom use).
RESULTS


At end line, 105 schools were included from the two provinces (44 from Mpumalanga and 61 from KwaZulu-Natal). Fifty-five were intervention and fifty were control schools. A total of 2802 girls were surveyed at both time periods (1477 intervention and 1325 control). At baseline, participating girls were about 13.6 years; by end line, they were about 2 years older. Longitudinal data demonstrated few differences between intervention and control groups on knowledge, attitudes, condom use, genital herpes, and pregnancy experience. Monitoring data demonstrated that the program was not implemented as intended. Our results demonstrated 7% incidence of genital herpes in the two-year follow-up period indicating sexual risk-taking among our cohort.
CONCLUSIONS


We did not find significant effects of the revised life orientation curriculum on key outcomes; however, this may reflect poor implementation. Future HIV prevention programs for young people need to be implemented with fidelity to ensure they meet the crucial needs of the next generation.
TRIAL REGISTRATION


This study has been registered at ClinicalTrials.gov . The trial registration number is: NCT04205721 . The trial was retrospectively registered on December 18, 2019.",2020,"Longitudinal data demonstrated few differences between intervention and control groups on knowledge, attitudes, condom use, genital herpes, and pregnancy experience.","['2016 from a cohort of grade-8 girls from Mpumalanga and KwaZulu-Natal Provinces in South Africa', 'two provinces in South Africa', 'Young people under age 25\u2009years', '2802 girls were surveyed at both time periods (1477 intervention and 1325 control', 'Fifty-five were intervention and fifty were control schools', '105 schools were included from the two provinces (44 from Mpumalanga and 61 from KwaZulu-Natal']","['school-based HIV prevention programs', 'scripted lesson plans']","['knowledge, attitudes, condom use behaviors, pregnancy incidence, and genital herpes incidence', 'genital herpes', 'knowledge, attitudes, condom use, genital herpes, and pregnancy experience']","[{'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0454729', 'cui_str': 'Natal'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C1948053', 'cui_str': 'Time periods'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0450382', 'cui_str': '55'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0019342', 'cui_str': 'Genital herpes simplex'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]",2802.0,0.0517119,"Longitudinal data demonstrated few differences between intervention and control groups on knowledge, attitudes, condom use, genital herpes, and pregnancy experience.","[{'ForeName': 'Ilene S', 'Initials': 'IS', 'LastName': 'Speizer', 'Affiliation': 'Carolina Population Center, University of North Carolina at Chapel Hill, 123 W. Franklin St., Chapel Hill, NC, 27516, USA. speizer@email.unc.edu.'}, {'ForeName': 'Mahua', 'Initials': 'M', 'LastName': 'Mandal', 'Affiliation': 'Carolina Population Center, University of North Carolina at Chapel Hill, 123 W. Franklin St., Chapel Hill, NC, 27516, USA.'}, {'ForeName': 'Khou', 'Initials': 'K', 'LastName': 'Xiong', 'Affiliation': 'Carolina Population Center, University of North Carolina at Chapel Hill, 123 W. Franklin St., Chapel Hill, NC, 27516, USA.'}, {'ForeName': 'Ndinda', 'Initials': 'N', 'LastName': 'Makina', 'Affiliation': 'Carolina Population Center, University of North Carolina at Chapel Hill, 123 W. Franklin St., Chapel Hill, NC, 27516, USA.'}, {'ForeName': 'Aiko', 'Initials': 'A', 'LastName': 'Hattori', 'Affiliation': 'Carolina Population Center, University of North Carolina at Chapel Hill, 123 W. Franklin St., Chapel Hill, NC, 27516, USA.'}, {'ForeName': 'Darryn', 'Initials': 'D', 'LastName': 'Durno', 'Affiliation': 'SADC Research Centre, Cape Town, South Africa, USA.'}]",BMC public health,['10.1186/s12889-020-09640-2']
3496,33054780,Flexible versus standard intramedullary rod in posterior stabilized primary total knee arthroplasty: protocol for a randomized controlled trial.,"BACKGROUND


In total knee arthroplasty (TKA) a flexible intramedullary rod can be used to account for sagittal bowing of the distal femur. Although patients report better post-operative functional outcome when the flexible rod was used, it is unknown how the use of the flexible rod affects the placement of the femoral TKA component, and how this relates to activities of daily living. It is expected that the use of the flexible rod will result in a more flexed femoral component, a larger patellar tendon moment arm, and consequently in better functional outcome. The goal of this study is to compare the flexible rod to the standard intramedullary rod in primary TKA in terms of fit of the TKA, functional outcome, and sizing of the femoral component.
METHODS


A single-blind randomized controlled trial with two groups (flexible vs standard rod), with patients blinded for group allocation, and 2 years post-operative follow-up. The fit of the TKA is quantified by two parameters: (1) the flexion angle of the TKA in the sagittal plane and (2) the sagittal profile of the distal femur compared between the pre-operative bone and the TKA. Both parameters are calculated in 3D volume images obtained using fluoroscopy. Functional outcome will be measured using (1) the timed Get-up and Go test (2), the stair climbing test (3), knee power output, and (4) patient and clinician reported outcomes. Different parameters will be measured during the TKA procedure to account for the invisibility of cartilage in the 3D volumes and to study if the amount of bone removed during the procedure is affected by group allocation.
DISCUSSION


The sagittal fit of TKA is not a standardized outcome measure. We discuss our choice of parameters to define the sagittal fit (i.e., flexion angle and sagittal profile), our choice for the parameters we measure during the TKA procedure to account for the lack of cartilage thickness in fluoroscopy, and our choice for the parameters to study if the amount of bone removed during the procedure is affected by group allocation. Lastly, we discuss the merits of this planned trial.
TRIAL REGISTRATION


Netherlands Trial Register, 4888 , registered 30 March 2015. https://www.trialregister.nl/trial/4888.",2020,In total knee arthroplasty (TKA) a flexible intramedullary rod can be used to account for sagittal bowing of the distal femur.,['posterior stabilized primary total knee arthroplasty'],"['total knee arthroplasty (TKA', 'Flexible versus standard intramedullary rod']",[],"[{'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0184512', 'cui_str': 'Stabilized'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0336581', 'cui_str': 'Intramedullary rod'}]",[],,0.0810919,In total knee arthroplasty (TKA) a flexible intramedullary rod can be used to account for sagittal bowing of the distal femur.,"[{'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'Bénard', 'Affiliation': 'Sint Maartenskliniek Research, Sint Maartenskliniek, Nijmegen, The Netherlands.'}, {'ForeName': 'R F M', 'Initials': 'RFM', 'LastName': 'van Doremalen', 'Affiliation': 'Robotics and Mechatronics, University of Twente, Enschede, The Netherlands.'}, {'ForeName': 'A B', 'Initials': 'AB', 'LastName': 'Wymenga', 'Affiliation': 'Sint Maartenskliniek Orthopaedics, Sint Maartenskliniek, Nijmegen, The Netherlands.'}, {'ForeName': 'P J C', 'Initials': 'PJC', 'LastName': 'Heesterbeek', 'Affiliation': 'Sint Maartenskliniek Research, Sint Maartenskliniek, Nijmegen, The Netherlands. p.heesterbeek@maartenskliniek.nl.'}]",Journal of orthopaedic surgery and research,['10.1186/s13018-020-01989-9']
3497,33058773,Photobiomodulation Enhances the Healing of Postextraction Alveolar Sockets: A Randomized Clinical Trial With Histomorphometric Analysis and Immunohistochemistry.,"PURPOSE


Wound healing of postextraction sockets is a complex process that permits to reach the bone reformation in about 3 months, and that could be characterized by the presence of some complications, mainly dependent on the duration of the surgery. The aim of this study is to evaluate the impact of photobiomodulation (PBMT) on the healing processes of mucosa overlying postextraction alveolus and on related complications.
METHODS


Twenty systemically healthy patients who needed to extract both lower third molars were selected in a private clinic and included in this prospective split-mouth randomized clinical trial. Inclusion criteria were no smokers subjects with the necessity to extract both lower third molars with surgeries overlapping for duration and difficulty. A computer-based randomization procedure was permitted to choose the side, subject to PBMT, by means of a neodymium-doped YAG (Nd: YAG) laser (test) and controls. Both surgeries were performed by the same operator with a gap of 40 days. Twenty-two days after each surgery, a biopsy in correspondence to the alveolar mucosa of the socket was obtained from both sites and observed with an optical microscope and analyzed with histomorphometric analysis and immunohistochemistry.
RESULTS


Each of the 20 participants included in this study (11 women and 9 men, nonsmokers, mean age 16 years in the range of 15 to 17 years) were subjected to the extraction of both lower third molars, and a side was treated as control, the other, as the test. The histomorphometric analysis and immunohistochemistry showed that the tested sites, contrary to controls, were characterized by a lower presence of inflammatory cells, a more mature epithelium and myofibroblasts incorporated in a network of fibers parallel to the basal membrane, with little positivity to alpha-SMA antibodies and anti-myosin but positivity to anti-desmin.
CONCLUSIONS


In conclusion, PBMT accelerates the healing process of postextraction alveolus after third molar extraction.",2020,"The histomorphometric analysis and immunohistochemistry showed that the tested sites, contrary to controls, were characterized by a lower presence of inflammatory cells, a more mature epithelium and myofibroblasts incorporated in a network of fibers parallel to the basal membrane, with little positivity to alpha-SMA antibodies and anti-myosin but positivity to anti-desmin.
CONCLUSIONS


","['Inclusion criteria were no smokers subjects with the necessity to extract both lower third molars with surgeries overlapping for duration and difficulty', '20 participants included in this study (11 women and 9 men, nonsmokers, mean age 16\xa0years in the range of 15 to 17 years', 'Twenty systemically healthy patients who needed to extract both lower third molars were selected in a private clinic']","['neodymium-doped YAG (Nd: YAG) laser (Test) and Controls', 'photobiomodulation (PBMT', 'Photobiomodulation', 'PBMT']","['healing process of postextraction alveolus', 'Healing of Postextraction Alveolar Sockets']","[{'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0227191', 'cui_str': 'Structure of lower third of esophagus'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0185027', 'cui_str': 'Imbrication'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0337672', 'cui_str': 'Non-smoker'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0033175', 'cui_str': 'Private Room'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0027599', 'cui_str': 'Neodymium'}, {'cui': 'C0013039', 'cui_str': 'Doping in Sports'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0227130', 'cui_str': 'Structure of alveolus dentalis'}, {'cui': 'C0224517', 'cui_str': 'Gomphosis structure'}]",11.0,0.0376832,"The histomorphometric analysis and immunohistochemistry showed that the tested sites, contrary to controls, were characterized by a lower presence of inflammatory cells, a more mature epithelium and myofibroblasts incorporated in a network of fibers parallel to the basal membrane, with little positivity to alpha-SMA antibodies and anti-myosin but positivity to anti-desmin.
CONCLUSIONS


","[{'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Scarano', 'Affiliation': 'Professor of Oral Surgery, Department of Medical, Oral and Biotechnological Sciences, University of Chieti-Pescara, Chieti, Italy; Research staff at Zirconia Implant Research Group (Z.I.R.G), International Academy of Ceramic Implantology; and Visiting Professor, Department of Oral Implantology, Dental Research Division, College Ingà, UNINGÁ, Cachoeiro de Itapemirim, Brazil. Electronic address: ascarano@unich.it.'}, {'ForeName': 'Felice', 'Initials': 'F', 'LastName': 'Lorusso', 'Affiliation': 'Student, Department of Medical, Oral and Biotechnological Sciences, University of Chieti-Pescara, Chieti, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Postiglione', 'Affiliation': 'Student of Oral Surgery Specialty, Department of Medical, Oral and Biotechnological Sciences, University of Chieti-Pescara, Chieti, Italy.'}, {'ForeName': 'Filiberto', 'Initials': 'F', 'LastName': 'Mastrangelo', 'Affiliation': 'Associate Professor of Oral Surgery Clinical and Experimental Medicine, Medical School, University of Foggia, Foggia, Italy.'}, {'ForeName': 'Morena', 'Initials': 'M', 'LastName': 'Petrini', 'Affiliation': 'Postdoctoral Researcher, Department of Medical, Oral and Biotechnological Sciences, University of Chieti-Pescara, Chieti, Italy.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2020.09.008']
3498,33058774,Third Molar Surgery Outcomes: A Randomized Clinical Trial Comparing Submucosal and Intravenous Dexamethasone.,"OBJECTIVE


Swelling, pain, and trismus after third molar surgery have a negative impact on patients' quality-of-life in the days following surgery. The study aims to compare the efficacy of submucosal (SM) dexamethasone and intravenous (IV) dexamethasone in reducing these outcomes.
METHODS


The single-center study was designed as a randomized, controlled, double-blinded trial with a total of 130 participants evenly allocated into 2 treatment groups. All participants underwent the surgical removal of at least 2 mandibular third molars under intravenous sedation. The outcome variables studied were swelling, pain, and maximum incisal distances. The swelling was measured using a 3-dimensional camera (3dMD Inc, Atlanta, GA). The pain was quantified using a 100 mm visual analog scale (VAS). Maximum incisal distances were measured using a caliper. Participants completed the short-form Oral Health Impact Profile (OHIP-14). The 2 groups were compared using cross-tabulations and chi-square tests for categorical variables and analysis of variance for continuous variables.
RESULTS


The participants had a mean age of 22.6 years, 56.8% females and 12.4% smokers. There were no statistically significant differences in the distribution of study variables between the 2 groups. On day 2, mean facial swelling measurements were 7.3 cm 3  in the IV group and 7.8 cm 3  in the SM group (P > .05). The mean pain score was 31 in the IV group and 33 in the SM group (P > .05). The mean maximum incisal distances were 33.7 mm in the IV group and 34.5 mm in the SM group (P > .05). Both groups experienced poorer quality-of-life relative to baseline scores and were affected to a similar extent.
CONCLUSIONS


There are no differences in swelling, pain, and trismus between submucosal and intravenous dexamethasone in third molar surgery. Submucosal dexamethasone is a straightforward and accessible route of steroid administration in patients having third molar surgery under local anesthesia only.",2020,The mean maximum incisal distances were 33.7 mm in the IV group and 34.5 mm in the SM group (P > .05).,"['participants had a mean age of 22.6\xa0years, 56.8% females and 12.4% smokers', '130 participants evenly allocated into two treatment groups', 'patients having third molar surgery under local anesthesia only', 'All participants underwent the surgical removal of at least two mandibular third molars under intravenous sedation', 'Third Molar Surgery Outcomes']","['Submucosal dexamethasone', 'dexamethasone', 'Dexamethasone', 'submucosal (SM) dexamethasone and intravenous (IV) dexamethasone']","['mean pain score', 'swelling, pain, and trismus', 'mean maximum incisal distances', 'mean facial swelling measurements', 'poorer quality-of-life', 'swelling, pain, and maximum incisal distances', 'short-form Oral Health Impact Profile (OHIP-14', 'Maximum incisal distances', 'pain']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517543', 'cui_str': '12.4'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1720162', 'cui_str': 'Under local anesthesia'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0412775', 'cui_str': 'Intravenous sedation'}, {'cui': 'C1274040', 'cui_str': 'Result'}]","[{'cui': 'C1515025', 'cui_str': 'Submucosal route'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0041105', 'cui_str': 'Trismus'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C4040028', 'cui_str': 'Incisal'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0151602', 'cui_str': 'Facial swelling'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}]",130.0,0.426829,The mean maximum incisal distances were 33.7 mm in the IV group and 34.5 mm in the SM group (P > .05).,"[{'ForeName': 'Adelyn Ai Lyn', 'Initials': 'AAL', 'LastName': 'Lau', 'Affiliation': 'Specialist Oral Surgeon - Private Practitioner, Faculty of Dentistry, University of Otago, Department of Oral Diagnostics and Surgical Sciences, Dunedin, New Zealand. Electronic address: Dr.adelynlau@gmail.com.'}, {'ForeName': 'Rohana Kumara', 'Initials': 'RK', 'LastName': 'De Silva', 'Affiliation': 'Associate Professor, Consultant Oral and Maxillofacial Surgeon, Faculty of Dentistry, University of Otago, Department of Oral Diagnostics and Surgical Sciences, Dunedin, New Zealand.'}, {'ForeName': 'Murray', 'Initials': 'M', 'LastName': 'Thomson', 'Affiliation': 'Professor of Dental Epidemiology and Public Health, Faculty of Dentistry, University of Otago, Department of Oral Sciences, Dunedin, New Zealand.'}, {'ForeName': 'Harsha', 'Initials': 'H', 'LastName': 'De Silva', 'Affiliation': 'Senior Lecturer, Consultant Oral and Maxillofacial Surgeon, Faculty of Dentistry, University of Otago, Department of Oral Diagnostics and Surgical Sciences, Dunedin, New Zealand.'}, {'ForeName': 'Darryl', 'Initials': 'D', 'LastName': 'Tong', 'Affiliation': 'Professor, Consultant Oral and Maxillofacial Surgeon, Head of Department of Oral Diagnostic and Surgical Sciences, Faculty of Dentistry, University of Otago, Department of Oral Diagnostics and Surgical Sciences, Dunedin, New Zealand.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2020.09.020']
3499,33058835,Exogenous testosterone decreases men's sensitivity to vocal cues of male dominance.,"Assessing dominance is important for effective social interactions, and prior research suggests that testosterone is associated with men's dominance perceptions. The present study tested for a causal effect of exogenous testosterone on men's sensitivity to vocal cues of other men's dominance, an important parameter in male-male competition across species. One hundred and thirty-nine Chinese men received a single dose (150 mg) of testosterone or placebo gel in a double-blind, placebo-controlled, between-participant design. Participants reported their own dominance and judged other men's dominance from voices. Men's dominance sensitivity was significantly weaker in the testosterone group compared to those in the placebo group. Moreover, men's dominance sensitivity was negatively associated with their self-reported dominance in our Chinese sample, consistent with findings from Western populations. These results indicate that exogenous testosterone has a causal effect in decreasing men's dominance sensitivity, consistent with the Challenge Hypothesis, suggesting that the fluctuation of testosterone concentration mediates individuals' behaviors. Additionally, the present study could motivate further work on vocal assessment in the context of competition in humans and other species.",2020,Men's dominance sensitivity was significantly weaker in the testosterone group compared to those in the placebo group.,"['One hundred and thirty-nine Chinese men', ""men's sensitivity to vocal cues of other men's dominance""]","['testosterone or placebo gel', 'Exogenous testosterone', 'testosterone', 'exogenous testosterone', 'placebo']","[""Men's dominance sensitivity""]","[{'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C1287621', 'cui_str': 'Eye dominance - finding'}]","[{'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0205101', 'cui_str': 'External'}]","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1287621', 'cui_str': 'Eye dominance - finding'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]",139.0,0.161778,Men's dominance sensitivity was significantly weaker in the testosterone group compared to those in the placebo group.,"[{'ForeName': 'Chengyang', 'Initials': 'C', 'LastName': 'Han', 'Affiliation': 'Shenzhen Key Laboratory of Affective and Social Cognitive Science, Shenzhen University, Shenzhen, China; School of Psychology, Shenzhen University, Shenzhen, China.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Watkins', 'Affiliation': 'Division of Psychology, School of Applied Sciences, Abertay University, Dundee, United Kingdom.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Nan', 'Affiliation': 'Shenzhen Key Laboratory of Affective and Social Cognitive Science, Shenzhen University, Shenzhen, China; School of Psychology, Shenzhen University, Shenzhen, China.'}, {'ForeName': 'Jianxin', 'Initials': 'J', 'LastName': 'Ou', 'Affiliation': 'Shenzhen Key Laboratory of Affective and Social Cognitive Science, Shenzhen University, Shenzhen, China; School of Psychology, Shenzhen University, Shenzhen, China.'}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Lei', 'Affiliation': 'School of Business Administration, Zhejiang University of Finance and Economics, Hangzhou, China.'}, {'ForeName': 'Xiangqian', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'School of Psychology, Shanghai University of Sport, Shanghai, China.'}, {'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Shenzhen Key Laboratory of Affective and Social Cognitive Science, Shenzhen University, Shenzhen, China; School of Psychology, Shenzhen University, Shenzhen, China. Electronic address: yinwu0407@gmail.com.'}]",Hormones and behavior,['10.1016/j.yhbeh.2020.104871']
3500,33059356,Acute dose-dependent effects of lysergic acid diethylamide in a double-blind placebo-controlled study in healthy subjects.,"Growing interest has been seen in using lysergic acid diethylamide (LSD) in psychiatric research and therapy. However, no modern studies have evaluated subjective and autonomic effects of different and pharmaceutically well-defined doses of LSD. We used a double-blind, randomized, placebo-controlled, crossover design in 16 healthy subjects (eight women, eight men) who underwent six 25 h sessions and received placebo, LSD (25, 50, 100, and 200 µg), and 200 µg LSD 1 h after administration of the serotonin 5-hydroxytryptamine-2A (5-HT 2A ) receptor antagonist ketanserin (40 mg). Test days were separated by at least 10 days. Outcome measures included self-rating scales that evaluated subjective effects, autonomic effects, adverse effects, plasma brain-derived neurotrophic factor levels, and pharmacokinetics up to 24 h. The pharmacokinetic-subjective response relationship was evaluated. LSD showed dose-proportional pharmacokinetics and first-order elimination and dose-dependently induced subjective responses starting at the 25 µg dose. A ceiling effect was observed for good drug effects at 100 µg. The 200 µg dose of LSD induced greater ego dissolution than the 100 µg dose and induced significant anxiety. The average duration of subjective effects increased from 6.7 to 11 h with increasing doses of 25-200 µg. LSD moderately increased blood pressure and heart rate. Ketanserin effectively prevented the response to 200 µg LSD. The LSD dose-response curve showed a ceiling effect for subjective good effects, and ego dissolution and anxiety increased further at a dose above 100 µg. These results may assist with dose finding for future LSD research. The full psychedelic effects of LSD are primarily mediated by serotonin 5-HT 2A  receptor activation.",2020,The 200 µg dose of LSD induced greater ego dissolution than the 100 µg dose and induced significant anxiety.,"['25, 50, 100, and 200\u2009µg), and 200\u2009µg LSD 1\u2009h after administration of the', '16 healthy subjects (eight women, eight men) who underwent six 25\u2009h sessions and received', 'healthy subjects']","['lysergic acid diethylamide', 'placebo, LSD', 'serotonin 5-hydroxytryptamine-2A (5-HT 2A ) receptor antagonist ketanserin', 'placebo', 'Ketanserin', 'LSD']","['blood pressure and heart rate', 'self-rating scales that evaluated subjective effects, autonomic effects, adverse effects, plasma brain-derived neurotrophic factor levels, and pharmacokinetics up to 24\u2009h', 'ego dissolution', 'average duration of subjective effects', 'ego dissolution and anxiety']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0024334', 'cui_str': 'Lysergic acid diethylamide'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0024334', 'cui_str': 'Lysergic acid diethylamide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C4543207', 'cui_str': 'Receptor antagonist'}, {'cui': 'C0022616', 'cui_str': 'Ketanserin'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C3179340', 'cui_str': 'Autonomic Effects'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0013712', 'cui_str': 'Ego'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",16.0,0.193,The 200 µg dose of LSD induced greater ego dissolution than the 100 µg dose and induced significant anxiety.,"[{'ForeName': 'Friederike', 'Initials': 'F', 'LastName': 'Holze', 'Affiliation': 'Department of Biomedicine and Department of Clinical Research, Clinical Pharmacology and Toxicology, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Vizeli', 'Affiliation': 'Department of Biomedicine and Department of Clinical Research, Clinical Pharmacology and Toxicology, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Ley', 'Affiliation': 'Department of Biomedicine and Department of Clinical Research, Clinical Pharmacology and Toxicology, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Müller', 'Affiliation': 'Psychiatric University Hospital, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Dolder', 'Affiliation': 'Department of Biomedicine and Department of Clinical Research, Clinical Pharmacology and Toxicology, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Stocker', 'Affiliation': 'Department of Biomedicine and Department of Clinical Research, Clinical Pharmacology and Toxicology, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Urs', 'Initials': 'U', 'LastName': 'Duthaler', 'Affiliation': 'Department of Biomedicine and Department of Clinical Research, Clinical Pharmacology and Toxicology, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Nimmy', 'Initials': 'N', 'LastName': 'Varghese', 'Affiliation': 'Psychiatric University Hospital, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Eckert', 'Affiliation': 'Psychiatric University Hospital, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Borgwardt', 'Affiliation': 'Psychiatric University Hospital, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Matthias E', 'Initials': 'ME', 'LastName': 'Liechti', 'Affiliation': 'Department of Biomedicine and Department of Clinical Research, Clinical Pharmacology and Toxicology, University Hospital Basel, Basel, Switzerland. matthias.liechti@usb.ch.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-00883-6']
3501,33059380,Postoperative Behaviour after Primary Strabismus Surgery in Children: Is There an Influence of Intraoperative Topical Anaesthesia?,"INTRODUCTION


The course of the recovery phase after general anaesthesia, during which consciousness and pain gradually return, is essentially determined by the choice of anaesthetic drug, and its total dose or duration of application. This phase is often complicated by more or less severe agitation, especially in children. In the present study we investigated whether the application of a topical anaesthetic to the conjunctiva at the end of a strabismus operation had a positive effect on the recovery behaviour of the child.
PATIENTS/METHODS


This prospective, randomised, blinded study was conducted with 50 healthy, ASA class I or II children, aged 3 to 8 years undergoing their first strabismus operation. Following the surgeon's randomisation two drops of a 0,5% tetracaine-HCl ophthalmic solution were applied to the operated conjunctiva three times at 30-s intervals immediately following wound closure. The postoperative evaluation encompassed heart rate, as well as COMFORT and CHEOPS scores. The first assessment was directly postoperatively with repetitions at 15, 30, 45, 60, 75, 90 and 120 min, as well as on the day after surgery.
RESULTS


The CHEOPS scores did not differ significantly between children with or without topical anaesthesia at any time during the observation period. The COMFORT scores revealed a slight, but non-significant analgesic effect at 15 and 30 min. The 60 min score showed the opposite effect, possibly indicating a slight disadvantage of the topical anaesthesia. There were no significant differences with regard to time to first request for additional systemic analgesia, to the total dose of systemic pain medication, or to when the patient was eligible for discharge to the ward.
CONCLUSION


The application of topical tetracaine-HCl immediately after wound closure had no positive effects on the course of the postoperative recovery period after strabismus surgery in children. There was no evidence of an effect on pain or emergence agitation.",2020,"There were no significant differences with regard to time to first request for additional systemic analgesia, to the total dose of systemic pain medication, or to when the patient was eligible for discharge to the ward.
","['children', 'Children', '50 healthy, ASA class I or II children, aged 3 to 8 years undergoing their first strabismus operation']","['tetracaine-HCl ophthalmic solution', 'topical tetracaine-HCl']","['pain or emergence agitation', 'CHEOPS scores', 'heart rate, as well as COMFORT and CHEOPS scores', 'time to first request for additional systemic analgesia', 'Postoperative Behaviour', 'COMFORT scores']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0441885', 'cui_str': 'Class 1'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0197981', 'cui_str': 'Strabismus surgery'}]","[{'cui': 'C0304456', 'cui_str': 'Tetracaine hydrochloride'}, {'cui': 'C0015399', 'cui_str': 'Eye drops'}, {'cui': 'C0332237', 'cui_str': 'Topical'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0920253', 'cui_str': 'Agitated Emergence'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0686900', 'cui_str': 'Request for'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",,0.103423,"There were no significant differences with regard to time to first request for additional systemic analgesia, to the total dose of systemic pain medication, or to when the patient was eligible for discharge to the ward.
","[{'ForeName': 'Nadja', 'Initials': 'N', 'LastName': 'Karstädt', 'Affiliation': 'Abteilung Augenheilkunde, Bereich Strabologie, Neuroophthalmologie und okuloplastische Chirurgie, Universitätsmedizin Göttingen, Deutschland.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Crozier', 'Affiliation': 'Klinik für Anästhesiologie, Universitätsmedizin Göttingen, Deutschland.'}, {'ForeName': 'Maren', 'Initials': 'M', 'LastName': 'Horn', 'Affiliation': 'Abteilung Augenheilkunde, Bereich Strabologie, Neuroophthalmologie und okuloplastische Chirurgie, Universitätsmedizin Göttingen, Deutschland.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Naxer', 'Affiliation': 'Abteilung Augenheilkunde, Bereich Strabologie, Neuroophthalmologie und okuloplastische Chirurgie, Universitätsmedizin Göttingen, Deutschland.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Schittkowski', 'Affiliation': 'Abteilung Augenheilkunde, Bereich Strabologie, Neuroophthalmologie und okuloplastische Chirurgie, Universitätsmedizin Göttingen, Deutschland.'}]",Klinische Monatsblatter fur Augenheilkunde,['10.1055/a-1260-3023']
3502,33059420,[Preliminary observation on the treatment of primary pterygium with modified conjunctival transplantation and amniotic membrane transplantation combined with use of interferon eye drops].,"Objective:  To observe the clinical effect of modified conjunctival transplantation and amniotic membrane transplantation combined with use of interferon (IFN) alpha-2b eye drops in the treatment of primary pterygium.  Methods:  This was a prospective case-control study. Patients with primary pterygium were treated from June 1, 2018 to December 31, 2018 in the Department of Ophthalmology, Beijing Tongren Hospital, and they were divided into two groups (the experimental group and the control group) by the method of randomized block design. Patients in the experimental group received modified conjunctival transplantation and amniotic membrane transplantation combined with use of IFN alpha-2b eye drops, while patients in the control group received pterygium resection combined with conjunctival autograft transplantation. The pterygium type and size were observed before operation, while visual acuity, intraocular pressure and anterior segment details were recorded either. The follow-up was done at 1 week, 2 weeks, 1 month, 3 months, 6 months and 12 months after operation. The visual acuity, corneal epithelial defect, and pterygium recurrence were observed. All data in this manuscript are enumeration data, the expected frequency of pterygium type distribution in the two groups was more than 5, and the chi square test was used, fisher's exact test was used to compare the other data between the two groups.  Results:  Seventy patients (77 eyes) with pterygium were in this study, including 30 males and 40 females, aged from 50-70 years old. There were 35 cases (38 eyes) in the experimental group and 35 cases (39 eyes) in the control group. 12 months after operation there were 54 cases (60 eyes) including 28 cases (30 eyes) in the experimental group and 26 cases (30 eyes) in the control group with complete data. The corneal epithelium defects of 1 eye in each group was repaired within 7-14 days after operation, and the rest eyes were completely repaired within 7 days after operation. There was no significant difference in the distribution of corneal epithelial healing between the two groups ( P = 1.00). There was no significant difference between the two groups in the number of eyes distribute with decreased visual acuity (2 eyes in each group), stable visual acuity (15 eyes in the experimental group and 23 eyes in the control group), and improved visual acuity (13 eyes in the experimental group and 5 eyes in the control group) ( P =0.053). There was no recurrence in the two groups at 12 months after surgery, and there was no significant difference between the two groups in the number of patients with conjunctival hyperplasia of grades 1, 2 and 3 ( P =0.405).  Conclusions:  Modified conjunctival transplantation and amniotic membrane transplantation combined with use of IFN alpha-2b eye drops got low recurrence rate for primary pterygium and less damage to the healthy conjunctival tissue. This combined treatment strategy provides a new choice for the treatment of pterygium . (Chin J Ophthalmol, 2020, 56: 768-773) .",2020,There was no significant difference in the distribution of corneal epithelial healing between the two groups ( P = 1.00).,"['Seventy patients (77 eyes) with pterygium were in this study, including 30 males and 40 females, aged from 50-70 years old', 'primary pterygium', 'primary pterygium and less damage to the healthy conjunctival tissue', 'Patients with primary pterygium were treated from June 1, 2018 to December 31, 2018 in the Department of Ophthalmology, Beijing Tongren Hospital']","['pterygium resection combined with conjunctival autograft transplantation', 'modified conjunctival transplantation and amniotic membrane transplantation combined with use of interferon (IFN) alpha-2b eye drops', 'Modified conjunctival transplantation and amniotic membrane transplantation combined with use of IFN alpha-2b eye', 'modified conjunctival transplantation and amniotic membrane transplantation combined with use of IFN alpha-2b eye drops', 'primary pterygium with modified conjunctival transplantation and amniotic membrane transplantation combined with use of interferon eye drops']","['distribution of corneal epithelial healing', 'stable visual acuity', 'number of patients with conjunctival hyperplasia', 'visual acuity, corneal epithelial defect, and pterygium recurrence', 'visual acuity', 'visual acuity, intraocular pressure and anterior segment details', 'corneal epithelium defects', 'number of eyes distribute with decreased visual acuity', 'no recurrence']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0033999', 'cui_str': 'Pterygium'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0029087', 'cui_str': 'Ophthalmology'}, {'cui': 'C4042832', 'cui_str': 'Peking'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0197133', 'cui_str': 'Simple excision of pterygium'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0040736', 'cui_str': 'Autogenous transplantation'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0002630', 'cui_str': 'Structure of amnion'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0021735', 'cui_str': 'Interferon Alfa-2b'}, {'cui': 'C0015399', 'cui_str': 'Eye drops'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0033999', 'cui_str': 'Pterygium'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}]","[{'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020507', 'cui_str': 'Hyperplasia'}, {'cui': 'C1299691', 'cui_str': 'Corneal epithelial defect'}, {'cui': 'C0033999', 'cui_str': 'Pterygium'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0003153', 'cui_str': 'Anterior eyeball segment structure'}, {'cui': 'C0854114', 'cui_str': 'Corneal epithelium defect'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0234632', 'cui_str': 'Reduced visual acuity'}]",,0.0325111,There was no significant difference in the distribution of corneal epithelial healing between the two groups ( P = 1.00).,"[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'Beijing Institute of Ophthalmology, Beijing Tongren Eye Center, Beijing Ophthalmology and Visual Science Key Laboratory, Beijing Tongren Hospital, Capital Medical University, Beijing 100730, China.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Feng', 'Affiliation': 'Beijing Institute of Ophthalmology, Beijing Tongren Eye Center, Beijing Ophthalmology and Visual Science Key Laboratory, Beijing Tongren Hospital, Capital Medical University, Beijing 100730, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Jie', 'Affiliation': 'Beijing Institute of Ophthalmology, Beijing Tongren Eye Center, Beijing Ophthalmology and Visual Science Key Laboratory, Beijing Tongren Hospital, Capital Medical University, Beijing 100730, China.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Jin', 'Affiliation': 'Beijing Institute of Ophthalmology, Beijing Tongren Eye Center, Beijing Ophthalmology and Visual Science Key Laboratory, Beijing Tongren Hospital, Capital Medical University, Beijing 100730, China.'}, {'ForeName': 'Z Q', 'Initials': 'ZQ', 'LastName': 'Pan', 'Affiliation': 'Beijing Institute of Ophthalmology, Beijing Tongren Eye Center, Beijing Ophthalmology and Visual Science Key Laboratory, Beijing Tongren Hospital, Capital Medical University, Beijing 100730, China.'}, {'ForeName': 'S Y', 'Initials': 'SY', 'LastName': 'Li', 'Affiliation': 'Beijing Institute of Ophthalmology, Beijing Tongren Eye Center, Beijing Ophthalmology and Visual Science Key Laboratory, Beijing Tongren Hospital, Capital Medical University, Beijing 100730, China.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': 'Beijing Institute of Ophthalmology, Beijing Tongren Eye Center, Beijing Ophthalmology and Visual Science Key Laboratory, Beijing Tongren Hospital, Capital Medical University, Beijing 100730, China.'}]",[Zhonghua yan ke za zhi] Chinese journal of ophthalmology,['10.3760/cma.j.cn112142-20191217-00651']
3503,33064780,"Alcohol use, depressive symptoms, and intimate partner violence perpetration: A longitudinal analysis among men with HIV in northern Vietnam.","BACKGROUND


While the link between alcohol use and male-perpetrated intimate partner violence (IPV) has been well-established, research is needed to test whether psychosocial factors interact with alcohol use to exacerbate IPV perpetration. We tested whether depressive symptoms influenced the strength and/or direction of the alcohol-IPV relationship among men with HIV in Vietnam.
METHODS


This study is a secondary analysis using data from a randomized controlled trial conducted in Thai Nguyen, Vietnam. Participants were clinic patients with HIV and hazardous alcohol use. Questionnaires were administered at baseline, three, six, and 12 months. Alcohol use was assessed as proportion of days alcohol abstinent. Analyses were restricted to males who reported being married/cohabitating at baseline (N = 313). Multilevel growth models were used to test whether time-varying depressive symptoms modified the time-varying effect of alcohol use on IPV perpetration.
RESULTS


Time-varying depressive symptoms modified the effect of proportion of days alcohol abstinent on IPV perpetration. However, the pattern of effect modification was not as expected, as reporting depressive symptoms weakened the alcohol-IPV relationship. At times when participants screened negative for depressive symptoms, those who reported higher proportion of days alcohol abstinent than usual had significantly lower odds of IPV perpetration (Odds Ratio [OR] = 0.17, 95% Confidence Interval 0.06, 0.45, p = 0.0004). At times when participants screened positive for depressive symptoms, there was no observed effect of alcohol use on IPV perpetration (OR = 4.28, 95% CI 0.80, 22.78, p = 0.09).
CONCLUSION


The findings highlight the complex nature of the alcohol-IPV relationship and the need to investigate the intersection between hazardous drinking, mental health, and IPV. Men who concurrently report depressive symptoms and heightened alcohol use may be socially isolated from an intimate partner or experiencing fatigue, leading to less alcohol-related IPV perpetration. Mental health interventions addressing depression and alcohol misuse integrated into HIV services may reduce IPV perpetration.",2020,"At times when participants screened positive for depressive symptoms, there was no observed effect of alcohol use on IPV perpetration (OR = 4.28, 95% CI 0.80, 22.78, p = 0.09).
","['males who reported being married/cohabitating at baseline', 'Men who concurrently report depressive symptoms and heightened alcohol use may be socially isolated from an intimate partner or experiencing fatigue, leading to less alcohol-related IPV perpetration', 'Participants were clinic patients with HIV and hazardous alcohol use', 'men with HIV in Vietnam', 'men with HIV in northern Vietnam', 'male-perpetrated intimate partner violence (IPV', 'Thai Nguyen, Vietnam']",[],"['Alcohol use, depressive symptoms, and intimate partner violence perpetration', 'depressive symptoms', 'IPV perpetration', 'alcohol use on IPV perpetration', 'proportion of days alcohol abstinent']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0555047', 'cui_str': 'Married'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0442803', 'cui_str': 'Heightened'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C0699756', 'cui_str': 'Intimate'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0042658', 'cui_str': 'Vietnam'}, {'cui': 'C0039724', 'cui_str': 'Thai language'}]",[],"[{'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0457801', 'cui_str': 'Non - drinker'}]",313.0,0.0537053,"At times when participants screened positive for depressive symptoms, there was no observed effect of alcohol use on IPV perpetration (OR = 4.28, 95% CI 0.80, 22.78, p = 0.09).
","[{'ForeName': 'Rebecca B', 'Initials': 'RB', 'LastName': 'Hershow', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States of America.'}, {'ForeName': 'H Luz McNaughton', 'Initials': 'HLM', 'LastName': 'Reyes', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States of America.'}, {'ForeName': 'Tran Viet', 'Initials': 'TV', 'LastName': 'Ha', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States of America.'}, {'ForeName': 'Geetanjali', 'Initials': 'G', 'LastName': 'Chander', 'Affiliation': 'Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, United States of America.'}, {'ForeName': 'Nguyen Vu Tuyet', 'Initials': 'NVT', 'LastName': 'Mai', 'Affiliation': 'Yen Hoa Health Clinic, University of North Carolina Vietnam, Hanoi, Vietnam.'}, {'ForeName': 'Teerada', 'Initials': 'T', 'LastName': 'Sripaipan', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States of America.'}, {'ForeName': 'Constantine', 'Initials': 'C', 'LastName': 'Frangakis', 'Affiliation': 'Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, United States of America.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Dowdy', 'Affiliation': 'Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, United States of America.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Latkin', 'Affiliation': 'Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, United States of America.'}, {'ForeName': 'Heidi E', 'Initials': 'HE', 'LastName': 'Hutton', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland, United States of America.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Pettifor', 'Affiliation': 'Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States of America.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Maman', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States of America.'}, {'ForeName': 'Vivian F', 'Initials': 'VF', 'LastName': 'Go', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States of America.'}]",PloS one,['10.1371/journal.pone.0240674']
3504,33065163,Metabolic impact of weight loss induced reduction of adipose ACE-2 - Potential implication in COVID-19 infections?,"BACKGROUND & AIMS


Angiotensin converting enzyme (ACE)-2 is a modulator of adipose tissue metabolism. However, human data of adipose ACE-2 is rarely available. Considering that, ACE-2 is believed to be the receptor responsible for cell entry of SARS-CoV-2, a better understanding of its regulation is desirable. We therefore characterized the modulation of subcutaneous adipose ACE-2 mRNA expression during weight loss and the impact of ACE-2 expression on weight loss induced short- and long-term improvements of glucose metabolism.
METHODS


143 subjects (age > 18; BMI ≥ 27 kg/m 2 ) were analyzed before and after a standardized 12-week dietary weight reduction program. Afterwards subjects were randomized to a 12-month lifestyle intervention or a control group (Maintain-Adults trial). Insulin sensitivity (IS) was estimated by HOMA-IR (as an estimate of liver IS) and ISI Clamp  (as an estimate of skeletal muscle IS). ACE-2 mRNA expression (ACE-2 AT ) was measured in subcutaneous adipose tissue before and after weight loss.
RESULTS


ACE-2 AT  was not affected by obesity, but was reduced in insulin resistant subjects. Weight loss resulted in a decline of ACE-2 AT  (29.0 (20.0-47.9) vs. 21.0 (13.0-31.0); p = 1.6 ∗ 10 -7 ). A smaller reduction of ACE-2  AT  (ΔACE-2 AT ) was associated with a larger improvement of ISI Clamp  (p = 0.013) during weight reduction over 3 months, but not with the extend of weight loss. The degree of changes in insulin resistance were preserved until month 12 and was also predicted by the weight loss induced degree of ΔACE-2 AT  (p = 0.011).
CONCLUSIONS


Our data indicate that subcutaneous adipose ACE-2 expression correlates with insulin sensitivity. Weight loss induced decline of subcutaneous adipose ACE-2 expression might affect short- and long-term improvement of myocellular insulin sensitivity, which might be also relevant in the context of ACE-2 downregulation by SARS-CoV-2.
TRIAL REGISTRATION


ClinicalTrials.gov number: NCT00850629, https://clinicaltrials.gov/ct2/show/NCT00850629, date of registration: February 25, 2009.",2020,"A smaller reduction of ACE-2  AT  (ΔACE-2 AT ) was associated with a larger improvement of ISI Clamp  (p = 0.013) during weight reduction over 3 months, but not with the extend of weight loss.",['143 subjects (age\u202f>\u202f18; BMI\u202f≥\u202f27\u202fkg/m 2 '],"['lifestyle intervention', 'ACE-2']","['Insulin sensitivity (IS', 'ACE-2  AT  (ΔACE-2 AT ', 'degree of changes in insulin resistance', 'Weight loss', 'ISI Clamp', 'ACE-2 mRNA expression (ACE-2 AT ']","[{'cui': 'C4517573', 'cui_str': '143'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0960880', 'cui_str': 'angiotensin converting enzyme 2'}]","[{'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0960880', 'cui_str': 'angiotensin converting enzyme 2'}, {'cui': 'C1097282', 'cui_str': '2-amino-5-(3,4-dimethoxyphenyl)-1,3,4-thiadiazole'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0175721', 'cui_str': 'Clamp'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}]",143.0,0.0156104,"A smaller reduction of ACE-2  AT  (ΔACE-2 AT ) was associated with a larger improvement of ISI Clamp  (p = 0.013) during weight reduction over 3 months, but not with the extend of weight loss.","[{'ForeName': 'Linna', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Endocrinology and Metabolism, 10117 Berlin, Germany; Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Clinical Research Unit, 10117 Berlin, Germany.'}, {'ForeName': 'Leonard', 'Initials': 'L', 'LastName': 'Spranger', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Endocrinology and Metabolism, 10117 Berlin, Germany.'}, {'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Soll', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Endocrinology and Metabolism, 10117 Berlin, Germany.'}, {'ForeName': 'Finja', 'Initials': 'F', 'LastName': 'Beer', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Endocrinology and Metabolism, 10117 Berlin, Germany.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Brachs', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Endocrinology and Metabolism, 10117 Berlin, Germany; Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Charité Center for Cardiovascular Research, 10117 Berlin, Germany.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Spranger', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Endocrinology and Metabolism, 10117 Berlin, Germany; Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Charité Center for Cardiovascular Research, 10117 Berlin, Germany; DZHK (German Centre for Cardiovascular Research), Berlin, Germany. Electronic address: joachim.spranger@charite.de.'}, {'ForeName': 'Knut', 'Initials': 'K', 'LastName': 'Mai', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Endocrinology and Metabolism, 10117 Berlin, Germany; Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Charité Center for Cardiovascular Research, 10117 Berlin, Germany; DZHK (German Centre for Cardiovascular Research), Berlin, Germany; Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Clinical Research Unit, 10117 Berlin, Germany.'}]",Metabolism: clinical and experimental,['10.1016/j.metabol.2020.154401']
3505,33065228,Short and long-term effects of water-based aerobic and concurrent training on cardiorespiratory capacity and strength of older women.,"Studies show that, in the short term, water-based aerobic training (WAT) promotes the same strength gains as water-based concurrent training (WCT). In addition, it is known that some training progression strategy must be employed after the first weeks of training in order to continue stimulating neuromuscular gains. The aim of this paper was to compare the effects of three water-based training on cardiorespiratory capacity and strength of older women in short and long-terms. Fifty-seven participants were randomized into the groups: 1) aerobic training (AT); 2) concurrent training whose resistance training progressed to the use of resistive equipment (CTRE); and 3) concurrent training whose resistance training progressed to multiple sets (CTMS). Participants trained twice a week for 16 weeks. An incremental treadmill test and the one-repetition maximal test of knee extensors were performed before and after 8 and 16 weeks. Peak oxygen consumption showed similar increases from pre to post-16 weeks (AT: 9%, CTRE: 11%, CTMS: 5%). Oxygen consumption at the second ventilatory threshold and strength were increased from pre to post-8 weeks (AT: 15%, CTRE: 16%, CTMS: 3% and AT: 9%, CTRE: 5%, CTMS: 9%, respectively) and from post-8 to post-16 weeks (AT: 6%, CTRE: 3%, CTMS: 12% and AT: 4%, CTRE: 8%, CTMS: 4%, respectively). In conclusion, the three training programs promoted similar increases in the cardiorespiratory capacity and WAT promoted similar strength gains as WCT in short and long terms. Moreover, the use of resistive equipment and the increase in the number of sets are effective progression strategies.",2020,Peak oxygen consumption showed similar increases from pre to post-16 weeks,"['older women', 'Fifty-seven participants', 'older women in short and long-terms']","['aerobic training (AT); 2) concurrent training whose resistance training progressed to the use of resistive equipment (CTRE); and 3) concurrent training whose resistance training progressed to multiple sets (CTMS', 'CTMS', 'three water-based training', 'water-based aerobic and concurrent training', 'water-based aerobic training (WAT']","['cardiorespiratory capacity and strength', 'Peak oxygen consumption', 'Oxygen consumption', 'strength gains']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517815', 'cui_str': '57'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0014672', 'cui_str': 'Equipment'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0661732', 'cui_str': 'cyclohexane-1,2,4-tris(methylenesulfonate)'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}]",57.0,0.0184618,Peak oxygen consumption showed similar increases from pre to post-16 weeks,"[{'ForeName': 'Thaís', 'Initials': 'T', 'LastName': 'Reichert', 'Affiliation': 'Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil. Electronic address: thais_reichert@hotmail.com.'}, {'ForeName': 'Rochelle Rocha', 'Initials': 'RR', 'LastName': 'Costa', 'Affiliation': 'Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Artur Avelino Birk', 'Initials': 'AAB', 'LastName': 'Preissler', 'Affiliation': 'Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Henrique Bianchi', 'Initials': 'HB', 'LastName': 'Oliveira', 'Affiliation': 'Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Cláudia Gomes', 'Initials': 'CG', 'LastName': 'Bracht', 'Affiliation': 'Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Bruna Machado', 'Initials': 'BM', 'LastName': 'Barroso', 'Affiliation': 'Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Vitória', 'Initials': 'V', 'LastName': 'de Mello Bones da Rocha', 'Affiliation': 'Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Andressa Freitas', 'Initials': 'AF', 'LastName': 'Correia', 'Affiliation': 'Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Luiz Fernando Martins', 'Initials': 'LFM', 'LastName': 'Kruel', 'Affiliation': 'Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}]",Experimental gerontology,['10.1016/j.exger.2020.111103']
3506,33065275,Vitamin D and survival in COVID-19 patients: A quasi-experimental study.,"Vitamin D may be a central biological determinant of COVID-19 outcomes. The objective of this quasi-experimental study was to determine whether bolus vitamin D3 supplementation taken during or just before COVID-19 was effective in improving survival among frail elderly nursing-home residents with COVID-19. Sixty-six residents with COVID-19 from a French nursing-home were included in this quasi-experimental study. The ""Intervention group"" was defined as those having received bolus vitamin D3 supplementation during COVID-19 or in the preceding month, and the ""Comparator group"" corresponded to all other participants. The primary and secondary outcomes were COVID-19 mortality and Ordinal Scale for Clinical Improvement (OSCI) score in acute phase, respectively. Age, gender, number of drugs daily taken, functional abilities, albuminemia, use of corticosteroids and/or hydroxychloroquine and/or antibiotics (i.e., azithromycin or rovamycin), and hospitalization for COVID-19 were used as potential confounders. The Intervention (n = 57; mean ± SD, 87.7 ± 9.3years; 79%women) and Comparator (n = 9; mean,87.4 ± 7.2years; 67%women) groups were comparable at baseline, as were the COVID-19 severity and the use of dedicated COVID-19 drugs. The mean follow-up time was 36 ± 17days. 82.5% of participants in the Intervention group survived COVID-19, compared to only 44.4% in the Comparator group (P = 0.023). The full-adjusted hazard ratio for mortality according to vitamin D3 supplementation was HR = 0.11[95%CI:0.03;0.48],P = 0.003. Kaplan-Meier distributions showed that Intervention group had longer survival time than Comparator group (log-rank P = 0.002). Finally, vitamin D3 supplementation was inversely associated with OSCI score for COVID-19 (β=-3.84[95%CI:-6.07;-1.62], P = 0.001). In conclusion, bolus vitamin D3 supplementation during or just before COVID-19 was associated in frail elderly with less severe COVID-19 and better survival rate.",2020,Kaplan-Meier distributions showed that Intervention group had longer survival time than Comparator group (log-rank P = 0.002).,"['frail elderly nursing-home residents with COVID-19', 'COVID-19 patients', 'Sixty-six residents with COVID-19 from a French nursing-home were included in this quasi-experimental study']","['corticosteroids and/or hydroxychloroquine and/or antibiotics (i.e., azithromycin or rovamycin', 'vitamin D3 supplementation', 'Vitamin D', 'bolus vitamin D3 supplementation']","['longer survival time', 'COVID-19 mortality and Ordinal Scale for Clinical Improvement (OSCI) score', 'survival rate', 'survival', 'Vitamin D and survival', 'OSCI score']","[{'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517841', 'cui_str': '66'}, {'cui': 'C0376246', 'cui_str': 'French language'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2985410', 'cui_str': 'Controlled Clinical Trials, Non-Randomized'}]","[{'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0878223', 'cui_str': 'Rovamycin'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}]",66.0,0.0876815,Kaplan-Meier distributions showed that Intervention group had longer survival time than Comparator group (log-rank P = 0.002).,"[{'ForeName': 'Cédric', 'Initials': 'C', 'LastName': 'Annweiler', 'Affiliation': 'Department of Geriatric Medicine and Memory Clinic, Research Center on Autonomy and Longevity, University Hospital, Angers, France; UPRES EA 4638, University of Angers, Angers, France; Robarts Research Institute, Department of Medical Biophysics, Schulich School of Medicine and Dentistry, the University of Western Ontario, London, ON, Canada. Electronic address: Cedric.Annweiler@chu-angers.fr.'}, {'ForeName': 'Bérangère', 'Initials': 'B', 'LastName': 'Hanotte', 'Affiliation': 'Department of Clinical Gerontology, University Hospital of Saint-Etienne, Saint-Etienne, France.'}, {'ForeName': 'Claire Grandin', 'Initials': 'CG', 'LastName': ""de l'Eprevier"", 'Affiliation': 'Geriatric hospital of Saint Laurent de Chamousset, Saint Laurent de Chamousset, France.'}, {'ForeName': 'Jean-Marc', 'Initials': 'JM', 'LastName': 'Sabatier', 'Affiliation': 'Université Aix-Marseille, Institut de Neuro-physiopathologie (INP), UMR 7051, Faculté de Pharmacie, 27 Bd Jean Moulin, 13385, Marseille Cedex, France.'}, {'ForeName': 'Ludovic', 'Initials': 'L', 'LastName': 'Lafaie', 'Affiliation': 'Department of Clinical Gerontology, University Hospital of Saint-Etienne, Saint-Etienne, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Célarier', 'Affiliation': 'Department of Clinical Gerontology, University Hospital of Saint-Etienne, Saint-Etienne, France; Chaire Santé des Ainés, University of Jean Monnet, Saint-Etienne, France; Gérontopôle Auvergne-Rhône-Alpes, Saint-Etienne, France.'}]",The Journal of steroid biochemistry and molecular biology,['10.1016/j.jsbmb.2020.105771']
3507,32067251,Randomized Controlled Trial of a Multilevel Intervention to Address Social Determinants of Refugee Mental Health.,"Understanding processes that support the well-being of the unprecedented numbers of forcibly displaced people throughout the world is essential. Growing evidence documents post-migration stressors related to marginalization as key social determinants of refugee mental health. The goal of this RCT was to rigorously test a social justice approach to reducing high rates of distress among refugees in the United States. The 6-month multilevel, strengths-based Refugee Well-being Project (RWP) intervention brought together university students enrolled in a 2-semester course and recently resettled refugees to engage in mutual learning and collaborative efforts to mobilize community resources and improve community and systems responsiveness to refugees. Data collected from 290 Afghan, Great Lakes African, Iraqi, and Syrian refugees at four time points over 12 months were used to test the effectiveness of RWP to reduce distress (depression and anxiety symptoms) and increase protective factors (English proficiency, social support, connection to home and American cultures). Intention-to-treat analyses using multilevel modeling revealed significant intervention effects for all hypothesized outcomes. Results provide evidence to support social justice approaches to improving refugee mental health. Findings have implications for refugees worldwide, and for other immigrant and marginalized populations who experience inequities in resources and disproportionate exposure to trauma/stress.",2020,Understanding processes that support the well-being of the unprecedented numbers of forcibly displaced people throughout the world is essential.,[],"['RWP', 'strengths-based Refugee Well-being Project (RWP) intervention', 'Multilevel Intervention']","['protective factors (English proficiency, social support, connection to home and American cultures', 'distress (depression and anxiety symptoms']",[],"[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0034961', 'cui_str': 'Refugees'}]","[{'cui': 'C0679688', 'cui_str': 'Protective Factors'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0037438'}, {'cui': 'C0449379', 'cui_str': 'Connection (attribute)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0220814', 'cui_str': 'culture'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}]",,0.0395065,Understanding processes that support the well-being of the unprecedented numbers of forcibly displaced people throughout the world is essential.,"[{'ForeName': 'Jessica R', 'Initials': 'JR', 'LastName': 'Goodkind', 'Affiliation': 'Department of Sociology, University of New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Bybee', 'Affiliation': 'Department of Psychology, Michigan State University, East Lansing, MI, USA.'}, {'ForeName': 'Julia Meredith', 'Initials': 'JM', 'LastName': 'Hess', 'Affiliation': 'Department of Pediatrics, University of New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'Suha', 'Initials': 'S', 'LastName': 'Amer', 'Affiliation': 'Center for Social Policy, University of New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Ndayisenga', 'Affiliation': 'Center for Social Policy, University of New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'R Neil', 'Initials': 'RN', 'LastName': 'Greene', 'Affiliation': 'Department of Sociology, University of New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'Ryeora', 'Initials': 'R', 'LastName': 'Choe', 'Affiliation': 'Department of Sociology, University of New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Isakson', 'Affiliation': 'Department of Psychiatry, University of New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'Brandon', 'Initials': 'B', 'LastName': 'Baca', 'Affiliation': 'Center for Social Policy, University of New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'Mahbooba', 'Initials': 'M', 'LastName': 'Pannah', 'Affiliation': 'Center for Social Policy, University of New Mexico, Albuquerque, NM, USA.'}]",American journal of community psychology,['10.1002/ajcp.12418']
3508,31863962,Burn injury and restoration of muscle function.,"Burn injury in children results in a systemic inflammatory reaction as well as a stress response. Consequences of these non-specific adaptive responses include resorptive bone loss and muscle catabolism. These adverse events can result in a post-burn fracture rate of approximately 15% and long-term muscle weakness that prolongs recovery. A randomized controlled trial of a single dose of the bisphosphonate pamidronate within the first ten days of burn injury resulted in the prevention of resorptive bone loss and continuous bone accrual. Examining the muscle protein kinetics in pediatric burn patients enrolled in that randomized controlled trial revealed that those who had been given the single dose bisphosphonate experienced preservation of muscle mass and strength. An in vitro study of mouse myoblasts incubated with serum from patients who participated in the randomized controlled study demonstrated that mouse myoblasts exposed to serum from patients given the single dose bisphosphonate exhibited greater myotube diameter than those from burned children given placebo. Moreover, the serum from bisphosphonate treated patients stimulated the protein anabolic pathways and suppressed protein catabolic pathways in these cells. Inasmuch as incubation of the myotubes with an antibody to transforming growth factor beta (TGFβ) rescued myotube size in the cultures with serum from patients who received the placebo to the same magnitude as cultures with serum from patients treated with single dose bisphosphonate, we postulate that post-burn bone resorption liberates muscle catabolic factors which cause muscle wasting. Future uses of bisphosphonates could include studies designed to prevent short-term acute bone resorption in conditions that may result in muscle wasting as well as in short-term interventions in chronic inflammatory conditions which may flare and cause acute bone and muscle loss.",2020,"Inasmuch as incubation of the myotubes with an antibody to transforming growth factor beta (TGFβ) rescued myotube size in the cultures with serum from patients who received the placebo to the same magnitude as cultures with serum from patients treated with single dose bisphosphonate, we postulate that post-burn bone resorption liberates muscle catabolic factors which cause muscle wasting.",['pediatric burn patients enrolled'],"['placebo', 'bisphosphonate pamidronate', 'bisphosphonate', 'bisphosphonates']","['muscle mass and strength', 'resorptive bone loss and continuous bone accrual']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0006434', 'cui_str': 'Burns'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0012544', 'cui_str': 'Bisphosphonates'}, {'cui': 'C0043603', 'cui_str': 'pamidronate'}]","[{'cui': 'C0240417', 'cui_str': 'Form of muscle (finding)'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}]",,0.0785012,"Inasmuch as incubation of the myotubes with an antibody to transforming growth factor beta (TGFβ) rescued myotube size in the cultures with serum from patients who received the placebo to the same magnitude as cultures with serum from patients treated with single dose bisphosphonate, we postulate that post-burn bone resorption liberates muscle catabolic factors which cause muscle wasting.","[{'ForeName': 'Gordon L', 'Initials': 'GL', 'LastName': 'Klein', 'Affiliation': 'Department of Orthopaedic Surgery and Rehabilitation, University of Texas Medical Branch, Galveston, TX 77555-0165, USA. Electronic address: gordonklein@ymail.com.'}]",Bone,['10.1016/j.bone.2019.115194']
3509,31497909,Letter on 'Pharmacy-based interdisciplinary intervention for patients with chronic heart failure: results of the PHARM-CHF randomized controlled trial'.,,2020,,['patients with chronic heart failure'],['Pharmacy-based interdisciplinary intervention'],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0264716', 'cui_str': 'Chronic heart failure (disorder)'}]","[{'cui': 'C0031322', 'cui_str': 'Pharmacies'}, {'cui': 'C0178499', 'cui_str': 'Base'}]",[],,0.0833479,,"[{'ForeName': 'Eran', 'Initials': 'E', 'LastName': 'Kalmanovich', 'Affiliation': 'Department of Cardiology, Montpellier University Hospital, Montpellier, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Roubille', 'Affiliation': 'Department of Cardiology, Montpellier University Hospital, Montpellier, France.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Castet-Nicolas', 'Affiliation': 'Department of Clinical Pharmacy, Montpellier University Hospital, Institut de Recherche en Cancérologie de Montpellier, INSERM U1194, Institut du Cancer de Montpellier, University of Montpellier, Montpellier, France.'}]",European journal of heart failure,['10.1002/ejhf.1602']
3510,31523887,Letter on 'Pharmacy-based interdisciplinary intervention for patients with chronic heart failure: results of the PHARM-CHF randomized controlled trial': reply.,,2020,,['patients with chronic heart failure'],"[""Letter on 'Pharmacy-based interdisciplinary intervention""]",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0264716', 'cui_str': 'Chronic heart failure (disorder)'}]","[{'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C0031322', 'cui_str': 'Pharmacies'}, {'cui': 'C0178499', 'cui_str': 'Base'}]",[],,0.0784457,,"[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Schulz', 'Affiliation': 'Department of Medicine, ABDA - Federal Union of German Associations of Pharmacists, Berlin, Germany.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Griese-Mammen', 'Affiliation': 'Department of Medicine, ABDA - Federal Union of German Associations of Pharmacists, Berlin, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Böhm', 'Affiliation': 'Department of Internal Medicine III - Cardiology, Angiology and Intensive Care Medicine, University Hospital of Saarland, Saarland University, Homburg/Saar, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Laufs', 'Affiliation': 'Department of Cardiology, University Hospital, Leipzig University, Leipzig, Germany.'}]",European journal of heart failure,['10.1002/ejhf.1613']
3511,31600006,High-power application is associated with shorter procedure time and higher rate of first-pass pulmonary vein isolation in ablation index-guided atrial fibrillation ablation.,"BACKGROUNDS


Ablation index (AI) is useful to complete circumferential pulmonary vein isolation (CPVI) for atrial fibrillation (AF), but the role of radiofrequency power in AI-guided CPVI remains to be elucidated.
METHODS


We investigated 60 patients with AF undergoing AI-guided CPVI (mean age, 66 ± 9 years; nonparoxysmal AF in 16). The first 40 patients were randomly assigned to low-power (LP; n = 20) and medium-power (MP; n = 20) groups and the following 20 patients to high-power (HP). In LP, radiofrequency (RF) application was done at 30 W at the anterior and 20 W at the posterior left atrial (LA) wall, while in MP, it was at 40 W at the anterior and 30 W at the posterior LA wall. In HP, 50 W was applied at the anterior, 40 W at posterior LA wall and 30 W on the esophagus. At each ablation point, target AI was 400 at the anterior, 360 at the posterior LA wall, and 260 on the esophagus.
RESULTS


The time to complete both-side CPVI was shortest in HP (median, 40 minutes, interquartile range [IQR], 28-63) followed by MP (58 [49-83] minutes, P = .008 vs HP) and LP (84 [72-93] minutes, P = .002 vs MP). Higher RF power application significantly increased first-pass isolation rate (55% in LP, 80% in MP and 85% in HP, P = .002) and decreased LA-PV reconnection rate (10% in LP, 8% in MP, and 0% in HP, P = .03).
CONCLUSION


In AI-guided PVI, the HP RF application can shorten the time to complete PVI with a high rate of first-pass isolation and a low rate of LA-PV reconnection.",2019,"Higher RF power application significantly increased first-pass isolation rate (55% in LP, 80% in MP and 85% in HP, P=0.002) and decreased LA-PV reconnection rate (10% in LP, 8% in MP and 0% in HP, P=0.03).
","['40 patients', '60 patients with AF undergoing AI-guided CPVI (mean age, 66±9 years; non-paroxysmal AF in 16']",[],"['time to complete both-side CPVI', 'LA-PV reconnection rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205311', 'cui_str': 'Paroxysmal (qualifier value)'}]",[],"[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}]",,0.0393837,"Higher RF power application significantly increased first-pass isolation rate (55% in LP, 80% in MP and 85% in HP, P=0.002) and decreased LA-PV reconnection rate (10% in LP, 8% in MP and 0% in HP, P=0.03).
","[{'ForeName': 'Hideharu', 'Initials': 'H', 'LastName': 'Okamatsu', 'Affiliation': 'Division of Cardiology, Saiseikai Kumamoto Hospital Cardiovascular Center, Kumamoto, Japan.'}, {'ForeName': 'Junjiro', 'Initials': 'J', 'LastName': 'Koyama', 'Affiliation': 'Division of Cardiology, Saiseikai Kumamoto Hospital Cardiovascular Center, Kumamoto, Japan.'}, {'ForeName': 'Yoshirou', 'Initials': 'Y', 'LastName': 'Sakai', 'Affiliation': 'Division of Cardiology, Saiseikai Kumamoto Hospital Cardiovascular Center, Kumamoto, Japan.'}, {'ForeName': 'Koudai', 'Initials': 'K', 'LastName': 'Negishi', 'Affiliation': 'Division of Cardiology, Saiseikai Kumamoto Hospital Cardiovascular Center, Kumamoto, Japan.'}, {'ForeName': 'Katsuhide', 'Initials': 'K', 'LastName': 'Hayashi', 'Affiliation': 'Division of Cardiology, Saiseikai Kumamoto Hospital Cardiovascular Center, Kumamoto, Japan.'}, {'ForeName': 'Takuo', 'Initials': 'T', 'LastName': 'Tsurugi', 'Affiliation': 'Division of Cardiology, Saiseikai Kumamoto Hospital Cardiovascular Center, Kumamoto, Japan.'}, {'ForeName': 'Yasuaki', 'Initials': 'Y', 'LastName': 'Tanaka', 'Affiliation': 'Division of Cardiology, Saiseikai Kumamoto Hospital Cardiovascular Center, Kumamoto, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Nakao', 'Affiliation': 'Division of Cardiology, Saiseikai Kumamoto Hospital Cardiovascular Center, Kumamoto, Japan.'}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Sakamoto', 'Affiliation': 'Division of Cardiology, Saiseikai Kumamoto Hospital Cardiovascular Center, Kumamoto, Japan.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Okumura', 'Affiliation': 'Division of Cardiology, Saiseikai Kumamoto Hospital Cardiovascular Center, Kumamoto, Japan.'}]",Journal of cardiovascular electrophysiology,['10.1111/jce.14223']
3512,31955410,"""In-House"" Data on the Outside-A Mobile Health Approach.","Mobile health (mHealth) technologies have the potential to capture dense patient data on the background of real-life behavior. Merck & Co., Inc. (Kenilworth, NJ), in collaboration with Koneksa Health, conducted a phase I clinical trial to validate cardiovascular mHealth technologies for concordance with traditional approaches and to establish sensitivity to detect effects of pharmacological intervention. This two-part study enrolled 18 healthy male subjects. Part I, a 5-day study, compared mHealth measures of heart rate (HR) and blood pressure (BP) to those from traditional methods. Hypotheses of similarity, in the clinic and at home, were tested individually for HR, systolic BP, and diastolic BP, at a 2-sided 0.05 alpha level, with a prespecified criterion for similarity being the percentage differences between the 2 measurements within 15%. Part II, a 7-day, 3-period randomized balanced crossover study, evaluated the mHealth technology's ability to detect effects of bisoprolol and salbutamol. Hypotheses that the changes from baseline in HR were greater in the bisoprolol (reduction in HR) and salbutamol (increase in HR) groups compared with no treatment were tested, at a 1-sided 0.05 alpha level. Linear mixed-effects models, Pearson's correlation coefficients, summary statistics, and exploratory plots were applied to analyze the data. The mHealth measures of HR and BP were demonstrated to be similar to those from traditional methods, and sensitive to changes in cardiovascular parameters induced by bisoprolol and salbutamol.",2020,"The mHealth measures of HR and BP were demonstrated to be similar to those from traditional methods, and sensitive to changes in cardiovascular parameters induced by bisoprolol and salbutamol.",['18 healthy male subjects'],['bisoprolol and salbutamol'],"['heart rate (HR) and blood pressure (BP', 'HR and BP', 'HR, systolic blood pressure, and diastolic blood pressure']","[{'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0053799', 'cui_str': 'Bisoprolol'}, {'cui': 'C0001927', 'cui_str': 'Albuterol'}]","[{'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}]",18.0,0.0263384,"The mHealth measures of HR and BP were demonstrated to be similar to those from traditional methods, and sensitive to changes in cardiovascular parameters induced by bisoprolol and salbutamol.","[{'ForeName': 'Qinlei', 'Initials': 'Q', 'LastName': 'Huang', 'Affiliation': 'Merck & Co., Inc, Kenilworth, New Jersey, USA.'}, {'ForeName': 'Tami', 'Initials': 'T', 'LastName': 'Crumley', 'Affiliation': 'Merck & Co., Inc, Kenilworth, New Jersey, USA.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Walters', 'Affiliation': 'Merck & Co., Inc, Kenilworth, New Jersey, USA.'}, {'ForeName': 'Liesbeth', 'Initials': 'L', 'LastName': 'Cluckers', 'Affiliation': 'Merck & Co., Inc, Kenilworth, New Jersey, USA.'}, {'ForeName': 'Ingeborg', 'Initials': 'I', 'LastName': 'Heirman', 'Affiliation': 'Merck & Co., Inc, Kenilworth, New Jersey, USA.'}, {'ForeName': 'Radha', 'Initials': 'R', 'LastName': 'Railkar', 'Affiliation': 'Merck & Co., Inc, Kenilworth, New Jersey, USA.'}, {'ForeName': 'Gaurav', 'Initials': 'G', 'LastName': 'Bhatia', 'Affiliation': 'Koneksa Health, New York, New York, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Cantor', 'Affiliation': 'Koneksa Health, New York, New York, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Benko', 'Affiliation': 'Koneksa Health, New York, New York, USA.'}, {'ForeName': 'Elena S', 'Initials': 'ES', 'LastName': 'Izmailova', 'Affiliation': 'Koneksa Health, New York, New York, USA.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Rottey', 'Affiliation': 'Drug Research Unit Ghent, Ghent, Belgium.'}, {'ForeName': 'S Aubrey', 'Initials': 'SA', 'LastName': 'Stoch', 'Affiliation': 'Merck & Co., Inc, Kenilworth, New Jersey, USA.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.1790']
3513,31294485,Mediating and Moderating Roles of Trust in Government in Effective Risk Rumor Management: A Test Case of Radiation-Contaminated Seafood in South Korea.,"This study has two aims: to identify effective strategies for managing false rumors about risks and to investigate the roles that basic and situational trust in government play in that process. Online experiment data were collected nationwide from 915 adults in South Korea. They were exposed to a false rumor about radiation-contaminated seafood and were randomly assigned to one of three rumor response conditions (refutation, denial, attack the attacker). One-way ANOVA indicated that the refutation response yielded the highest level of situational trust in government response (TGR). Results of moderated mediation models using the PROCESS Macro indicated the following. (1) The refutation response had a positive effect on TGR, and the attack response had a negative effect. (2) There were significant interaction effects between the attack response and preexisting basic trust in government (BTG) in that the attack response had a negative effect on TGR only when BTG was low. (3) TGR significantly mediated the relationship between each of the three rumor responses and two dependent variables (intentions for rumor dissemination and for unwarranted actions), but in dramatically different ways across the responses. This study provides evidence for the superior effectiveness of the refutation rumor response and identifies specific roles of trust in government in the risk rumor management process.",2019,One-way ANOVA indicated that the refutation response yielded the highest level of situational trust in government response (TGR).,"['South Korea', '915 adults in South Korea']",[],"['highest level of situational trust in government response (TGR', 'attack response and preexisting basic trust in government (BTG']","[{'cui': 'C0022773', 'cui_str': 'South Korea'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]",[],"[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0018104', 'cui_str': 'Government'}, {'cui': 'C1304680', 'cui_str': 'Attack (finding)'}]",915.0,0.0280747,One-way ANOVA indicated that the refutation response yielded the highest level of situational trust in government response (TGR).,"[{'ForeName': 'Hye-Jin', 'Initials': 'HJ', 'LastName': 'Paek', 'Affiliation': 'Department of Advertising & Public Relations, Hanyang University, Ansan, South Korea.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hove', 'Affiliation': 'Department of Advertising & Public Relations, Hanyang University, Ansan, South Korea.'}]",Risk analysis : an official publication of the Society for Risk Analysis,['10.1111/risa.13377']
3514,32248849,Longitudinal associations between ultra-processed foods and blood lipids in childhood.,"Emerging evidence suggests that the consumption of ultra-processed foods (UPF) plays a role in the development of chronic diseases, but evidence of their influence in children is limited. Our objective was to study longitudinal trends of UPF intake and determine their impact on blood lipids in young children. The present study was a follow-up of a randomised field trial of children (n 308) from Porto Alegre, Brazil. Dietary intake was collected using two 24-h recalls at 3 and 6 years of age, and consumption of UPF was classified according to the NOVA system, a food classification based on the extent and purpose of industrial food processing. At age 6 years, blood tests were performed to measure lipid profile. Contribution of UPF to total energy intake increased by 10 % during the follow-up period, from 43·4 % at 3 years to 47·7 % at 6 years of age. Linear regression models showed that children in the highest tertile of UPF consumption at age 3 years had higher levels of total cholesterol (TC; β 0·22 mmol/l; 95 % CI 0·04, 0·39) and TAG at age 6 years (β 0·11 mmol/l, 95 % CI 0·01, 0·20) compared with those in the lowest tertile. A positive dose-response was observed for an absolute increment of 10 % of UPF on TC (β 0·07 mmol/l, 95 % CI 0·00, 0·14) and TAG (β 0·04 mmol/l, 95 % CI 0·01, 0·07). Based on our data, consumption of UPF increased significantly over time and was associated with higher blood lipid levels in children from a low-income community. Our findings highlight the need for effective strategies to minimise the consumption of UPF in early life.",2020,"Based on our data, consumption of UPF increased significantly over time and was associated with higher blood lipids levels in children from a low-income community.","['children (n=308) from Porto Alegre, Brazil', 'young children', 'childhood']",[],"['blood lipids', 'Dietary intake', 'blood lipids levels', 'total cholesterol', 'UPF consumption', 'total energy intake']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}]",[],"[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0428460', 'cui_str': 'Lipid level - finding'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}]",,0.0461934,"Based on our data, consumption of UPF increased significantly over time and was associated with higher blood lipids levels in children from a low-income community.","[{'ForeName': 'Paula S', 'Initials': 'PS', 'LastName': 'Leffa', 'Affiliation': 'Graduate Program of Health Sciences, Universidade Federal de Ciências da Saúde de Porto Alegre, Porto Alegre, Brazil.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Hoffman', 'Affiliation': 'Department of Nutritional Sciences, New Jersey Institute for Food, Nutrition, and Health, Center for Childhood Nutrition Research, Rutgers, the State University of New Jersey, New Brunswick, NJ, USA.'}, {'ForeName': 'Fernanda', 'Initials': 'F', 'LastName': 'Rauber', 'Affiliation': 'Department of Nutrition, School of Public Health, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Caroline N', 'Initials': 'CN', 'LastName': 'Sangalli', 'Affiliation': 'Graduate Program of Health Sciences, Universidade Federal de Ciências da Saúde de Porto Alegre, Porto Alegre, Brazil.'}, {'ForeName': 'Júlia L', 'Initials': 'JL', 'LastName': 'Valmórbida', 'Affiliation': 'Graduate Program in Pediatrics: Child and Adolescent Health Care, Universidade Federal de Ciências da Saúde de Porto Alegre, Porto Alegre, Brazil.'}, {'ForeName': 'Márcia R', 'Initials': 'MR', 'LastName': 'Vitolo', 'Affiliation': 'Graduate Program of Health Sciences, Universidade Federal de Ciências da Saúde de Porto Alegre, Porto Alegre, Brazil.'}]",The British journal of nutrition,['10.1017/S0007114520001233']
3515,32055011,"Comments on ""The effects of a multispecies probiotic on migraine and markers of intestinal permeability-results of a randomized placebo-controlled study"" by de Roos et al.",,2020,,[],"['placebo', 'multispecies probiotic']",[],[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}]",[],,0.0496701,,"[{'ForeName': 'Meysam', 'Initials': 'M', 'LastName': 'Zarezadeh', 'Affiliation': ""Department of Clinical Nutrition, Student's Research Committee, Nutrition Research Center, School of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Tabriz, Iran. zarezadehm@tbzmed.ac.ir.""}]",European journal of clinical nutrition,['10.1038/s41430-020-0586-7']
3516,32109638,"Effects of Apremilast, an Oral Inhibitor of Phosphodiesterase 4, in a Randomized Trial of Patients With Active Ulcerative Colitis.",,2020,,['Patients with Active Ulcerative Colitis'],[],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0009324', 'cui_str': 'Inflammatory Bowel Disease, Ulcerative Colitis Type'}]",[],[],,0.0747077,,"[{'ForeName': 'Radhika', 'Initials': 'R', 'LastName': 'Nittala', 'Affiliation': 'Department of Gastroenterology, Institute of Medical Sciences (IMS) and SUM Hospital, Siksha O Anusandhan, Deemed to be University, Bhubaneswar, Odisha, India.'}, {'ForeName': 'Ayaskanta', 'Initials': 'A', 'LastName': 'Singh', 'Affiliation': 'Department of Gastroenterology, Institute of Medical Sciences (IMS) and SUM Hospital, Siksha O Anusandhan, Deemed to be University, Bhubaneswar, Odisha, India.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2020.02.038']
3517,30726984,"Can Removing Tar Information From Cigarette Packages Reduce Smokers' Misconceptions About Low-Tar Cigarettes? An Experiment From One of the World's Lowest Tar Yield Markets, South Korea.","INTRODUCTION


Despite regulations that forbid cigarette packages from displaying messages such as ""mild,"" ""low-tar,"" and ""light,"" many smokers still have misperceptions about ""light"" or ""low-tar"" cigarettes. One reason may be that tar amount displays continue to be permitted. This study examines whether removing tar delivery information from packaging reduces consumer misperceptions about ""low-tar"" cigarettes.
METHODS


An online experiment was conducted in South Korea among 531 smokers who were randomly assigned to one of two conditions: with and without tar information on cigarette packages. Participants evaluated which type of cigarette was mildest, least harmful, easiest for nonsmokers to start smoking, and easiest for smokers to quit.
RESULTS


Ten out of 12 chi-square tests showed that people judged the lowest reported tar delivery cigarette to be the mildest (p < .01), least harmful (p < .05), easiest to start (p < .05), and easiest to quit (p < .05)-less so in the ""no-tar"" condition than the ""tar"" condition. A higher level of misbeliefs about supposed low-tar cigarettes were found in the ""tar"" condition compared to the ""no-tar"" condition for all three brands (t = 5.85, 4.07, 3.82, respectively, p < .001). Regression analyses showed that the ""no-tar"" condition negatively predicted the level of misbeliefs after controlling for demographic and smoking-related variables (B [SE] = -.72 (.12), -.50 (.12), -.48 (.13), respectively, p < .001).
CONCLUSIONS


Banning reported tar deliveries from cigarette packages is likely to reduce smokers' misconceptions about ""low-tar"" cigarettes. When reported tar deliveries are absent, smokers have inconsistent judgments about differently packaged cigarettes.
IMPLICATIONS


When cigarette packages depict lower reported tar number deliveries, participants erroneously perceive them to be less harmful than packages displaying higher tar numbers. These misperceptions of harm may prompt smokers who might otherwise attempt to quit smoking to instead consume cigarettes with lower tar deliveries due to the mistaken belief that they will reduce their risk.",2020,"A higher level of misbeliefs about supposed low-tar cigarettes were found in the ""tar"" condition compared to the ""no tar"" condition for all three brands (t = 5.85, 4.07, 3.82, respectively, p < .001).",['South Korea among 531 smokers'],[],['delivery cigarette'],"[{'cui': 'C0022773', 'cui_str': 'South Korea'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]",[],"[{'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}]",531.0,0.0139176,"A higher level of misbeliefs about supposed low-tar cigarettes were found in the ""tar"" condition compared to the ""no tar"" condition for all three brands (t = 5.85, 4.07, 3.82, respectively, p < .001).","[{'ForeName': 'Hye-Jin', 'Initials': 'HJ', 'LastName': 'Paek', 'Affiliation': 'Department of Advertising and Public Relations, Hanyang University, Ansan, South Korea.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Dewhirst', 'Affiliation': 'Department of Marketing and Consumer Studies, University of Guelph, Guelph, Ontario, Canada.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hove', 'Affiliation': 'Department of Advertising and Public Relations, Hanyang University, Ansan, South Korea.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz016']
3518,31802616,Effects of treatment with metformin and/or sitagliptin on beta-cell function and insulin resistance in prediabetic women with previous gestational diabetes.,"AIM


To investigate the effect of sitagliptin (SITA) and metformin (MET) monotherapy as well as in combination (MET+SITA) on beta-cell function and insulin sensitivity in women with recent gestational diabetes (GDM) and impaired glucose regulation (IGR: impaired fasting glucose and/or impaired glucose tolerance).
MATERIAL AND METHODS


Forty women were randomly assigned to receive SITA (100 mg qd), MET (850 mg bid) or MET+SITA (50 + 850 mg bid) for 16 weeks. A 75 g oral glucose tolerance test (OGTT) and +125 mg/dL hyperglycaemic clamp followed by 5 g i.v. L-arginine were performed at baseline and end of study. The primary outcome of the study was the mean change in arginine-stimulated insulin secretion rate during the hyperglycaemic clamp test from baseline to 16-week therapy.
RESULTS


At week 16, body mass index declined in all groups (-1.2 ± 0.2 kg/m 2  ; P < 0.05). MET+SITA gave a greater increase of first phase (2-10 min)  insulin secretion and arginine-stimulated response (720.3 ± 299.0 to 995.5 ± 370.3 pmol/L and 3.2 ± 0.6 to 4.8 ± 1.0 pmoL/min, respectively, both P < 0.05) compared with MET and SITA. Similarly, MET+SITA was more effective in increasing OGTT-based glucose sensitivity (55.7 ± 11.3 to 108 ± 56.2 pmol x min -1  m -2  x mM -1  ; P = 0.04) and insulin-stimulated glucose disposal (M/I: 2.2 ± 0.5 to 4.6 ± 1.3 mg/kg/min÷μIU/min/ml; P = 0.04; Matsuda index [SI]: 3.1 ± 0.4 to 5.7 ± 1.1; P = 0.03) compared with either MET or SITA. Disposition index (ISSI-2) increased with MET+SITA and SITA (both P < 0.05), while no significant change was observed in MET. Among MET+SITA women, 33% reverted to normal glucose tolerance (NGT) compared with 14% with MET and 7% with SITA (P < 0.05).
CONCLUSION


This study shows that MET+SITA is superior to SITA and MET monotherapy regarding beta-cell function and insulin sensitivity improvement in IGR women with previous GDM, and may offer a potential pharmacologic intervention to reduce the risk of type 2 diabetes in this high-risk population.",2020,Disposition Index (ISSI-2) increased with MET+SITA and SITA (both p<0.05) while no significant change was observed in MET.,"['Prediabetic Women With Previous Gestational Diabetes', 'Forty women', 'women with recent gestational diabetes (GDM) and impaired glucose regulation (IGR: IFG and/or IGT', 'IGR women with previous GDM']","['SITA', 'sitagliptin (SITA) and metformin (MET) monotherapy', 'Metformin and/or Sitagliptin']","['insulin sensitivity', 'effective in increasing OGTT-based glucose sensitivity', 'Disposition Index (ISSI-2', 'Beta-cell Function and Insulin Resistance', 'insulin secretion and arginine-stimulated response', 'mean change in arginine-stimulated insulin secretion rate', 'BMI']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0439671', 'cui_str': 'Gestational (qualifier value)'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0085207', 'cui_str': 'Diabetes, Pregnancy-Induced'}]","[{'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0743223', 'cui_str': 'Disposition (disposition)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C1256369', 'cui_str': 'Insulin Secretion'}, {'cui': 'C0968133', 'cui_str': 'alpha-(trifluoromethyl)arginine'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",40.0,0.0299209,Disposition Index (ISSI-2) increased with MET+SITA and SITA (both p<0.05) while no significant change was observed in MET.,"[{'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Daniele', 'Affiliation': 'Section of Metabolic Diseases and Diabetes, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Tura', 'Affiliation': 'Metabolic Unit, CNR Institute of Neuroscience, Padova, Italy.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Dardano', 'Affiliation': 'Section of Metabolic Diseases and Diabetes, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Bertolotto', 'Affiliation': 'Section of Metabolic Diseases and Diabetes, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Bianchi', 'Affiliation': 'Section of Metabolic Diseases and Diabetes, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Giusti', 'Affiliation': 'Section of Metabolic Diseases and Diabetes, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Jancy Joseph', 'Initials': 'JJ', 'LastName': 'Kurumthodathu', 'Affiliation': 'Section of Metabolic Diseases and Diabetes, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Del Prato', 'Affiliation': ''}]","Diabetes, obesity & metabolism",['10.1111/dom.13940']
3519,32044820,Comparative study of spironolactone and eplerenone in management of ascites in patients of cirrhosis of liver.,"INTRODUCTION


The present study was conducted to compare the efficacy and side effects of Spironolactone and Eplerenone in management of ascites due to liver cirrhosis.
MATERIALS AND METHODS


105 patients of ascites with liver cirrhosis were randomized into three groups of 35 patients each. Group I was given Spironolactone 100 mg, group II was given Eplerenone 100 mg and group III was given Eplerenone 50 mg. All patients were put on salt-restricted diet (less than or equal to 2 g of sodium) and no loop diuretics were used. Patients were followed after 7 days from the baseline and then biweekly for the period of three months and serial measurements of weight, abdominal girth and incidence of side effects especially gynecomastia, mastalgia, hyperkalemia were recorded. Results were compared. Patients having Child-Turcotte-Pugh score-C, massive ascites, hepatic encephalopathy, Hepatorenal syndrome and ascites due to cardiac, renal, malignant causes were excluded.
OBSERVATIONS


Difference in mean weight reduction was non significant (P = 0.964) in group I and group II whereas the difference was significant when comparison was made between Group I and III; and Group II and III (P = <0.001, <0.001, respectively). In group I, the incidence of gynecomastia was 14.28% whereas in group II and group III no case of gynecomastia was observed (P <0.001, <0.001). Hyperkalemia was present in one patient (2.8%) in group I whereas no patient developed hyperkalemia in group II and group III (P = >0.05, >0.05).
CONCLUSION


Eplerenone and spironolactone are equally effective in management of ascites due to liver cirrhosis but side effect profile of eplerenone scores over Spironolactone.",2020,"OBSERVATIONS


Difference in mean weight reduction was non significant (P = 0.964) in group I and group II whereas the difference was significant when comparison was made between Group I and III; and Group II and III","['105 patients of ascites with liver cirrhosis', 'Patients having Child-Turcotte', 'patients of cirrhosis of liver']","['Spironolactone', 'Eplerenone and spironolactone', 'Eplerenone', 'Eplerenone 50 mg', 'salt-restricted diet (less than or equal to 2 g of sodium) and no loop diuretics', 'spironolactone and eplerenone', 'Spironolactone and Eplerenone']","['incidence of gynecomastia', 'Hyperkalemia', 'hyperkalemia', 'mean weight reduction', 'weight, abdominal girth and incidence of side effects especially gynecomastia, mastalgia, hyperkalemia', 'gynecomastia']","[{'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003962', 'cui_str': 'Ascites'}, {'cui': 'C0023890', 'cui_str': 'Hepatic Cirrhosis'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0037982', 'cui_str': 'Spironolactone'}, {'cui': 'C0961485', 'cui_str': 'eplerenone'}, {'cui': 'C1171045', 'cui_str': 'eplerenone 50 MG'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0443288', 'cui_str': 'Restricted (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0354100', 'cui_str': 'Loop Diuretics'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0018418', 'cui_str': 'Male Breast Enlargement'}, {'cui': 'C0020461', 'cui_str': 'Hyperpotassemia'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0024902', 'cui_str': 'Mammalgia'}]",105.0,0.0134091,"OBSERVATIONS


Difference in mean weight reduction was non significant (P = 0.964) in group I and group II whereas the difference was significant when comparison was made between Group I and III; and Group II and III","[{'ForeName': 'Rishabh', 'Initials': 'R', 'LastName': 'Sehgal', 'Affiliation': 'Department of Gastroenterology, DMC&H LDH, Punjab.'}, {'ForeName': 'Harsimranjit', 'Initials': 'H', 'LastName': 'Singh', 'Affiliation': 'Department of Cardiology, Shri Jayadeva Institute of Cardiology, Banglore.'}, {'ForeName': 'Inder Pal', 'Initials': 'IP', 'LastName': 'Singh', 'Affiliation': 'Department of Medicine, GMC Patiala, Punjab, India.'}]",European journal of gastroenterology & hepatology,['10.1097/MEG.0000000000001678']
3520,31407484,Perioperative analgesia with parecoxib sodium improves postoperative pain and immune function in patients undergoing hepatectomy for hepatocellular carcinoma.,"RATIONALE, AIMS, AND OBJECTIVES


Acute postoperative pain can result in immune dysfunction, which can be partly mitigated by efficient pain management. Opioids that have been widely applied to analgesia have been shown to suppress immune function, which has a negative impact on the treatment of patients with cancer. This study investigated the effects of perioperative fentanyl analgesia alone or in combination with parecoxib sodium on postoperative pain, immune function, and prognosis in patients undergoing hepatectomy of hepatocellular carcinoma (HCC).
METHODS


A total of 80 patients scheduled for hepatectomy between October 2013 and August 2014 were included. Patients were randomly divided into two groups (n = 40) and allocated to receive parecoxibsodium 40 mg (group P) or placebo (group C) 30 minutes before induction of anaesthesia, followed by 40 mg every 12 hours for 48 hours after the operation. All patients had access to patient-controlled analgesia with intravenous fentanylpostoperatively. Venous blood samples were collected at the following time points: 30 minutes before induction of anaesthesia (T0), the end of the surgery (T1), 24 hours after surgery (T2), and 72 hours after surgery (T3). The percentages of CD3+, CD4+, CD8+, CD4+/CD8+ T cells, and CD3+CD16+CD56+ (NK) cells at these time points were quantified by flow cytometry (FCM).Visual analogue scale (VAS) scores, total fentanyl consumption, and adverse effects were recorded. The prognostic differences in overall survival (OS) and disease-free survival (DFS) between the two groups was also investigated.
RESULTS


For both groups, the percentages of CD3+, CD4+ T cells, and the ratio of CD4+/CD8+ significantly decreased at T1 and T2 (P < .05). The percentages of CD3+ T cells were significantly lower in group C than that in group P at T2 (P < .05). In group C, the amount of CD3+ T cells was lower at T3 compared with T0 (P < .05). The percentages of NK cells significantly decreased at T1 in both groups (P < .05). The percentages of NK in group P were recovered nearly to baseline (T0) at T2, which was higher than that of group C (P < .05). In group C, the percentages of NK cells have not recovered nearly to baseline at T3 compared with T0 (P < .05). VAS scores at rest and on cough in group P were significantly lower than those in group C at 2, 6, 12, and 24 hours after operation (P < .05), and there were no significant differences in VAS scores between the two groups at 48 hours after surgery (P > .05). There were no significant differences regarding the incidence of adverse effects between the two groups (P > .05). Kaplan-Meier analysis indicated that the DFS time in group P was significantly longer than in group C (19.0 months, 95% confidence interval [CI], 9.8-28.2 vs 14.0 months, 95% CI, 8.1-19.9; P < .05). There was no significant difference in OS time (36.0 months, 95% CI, 13.4-58.9 vs 14.0 months, 95% CI, 10.6-25.4; P > .05) between two groups.
CONCLUSIONS


The present study indicated that perioperative analgesia of parecoxib sodium combined with patient-controlled analgesic fentanyl resulted in better preserved immune function with enhancement of the analgesic efficacy to fentanyl alone of HCC patients undergoing hepatectomy and helped postpone postoperative tumour recurrence.",2020,"In group C, the amount of CD3+ T cells was lower at T3 compared with T0 (P < .05).","['80 patients scheduled for hepatectomy between October 2013 and August 2014 were included', 'patients undergoing hepatectomy for hepatocellular carcinoma', 'All patients had access to patient-controlled analgesia with intravenous fentanylpostoperatively', 'patients with cancer', 'patients undergoing hepatectomy of hepatocellular carcinoma (HCC', 'HCC patients undergoing hepatectomy and helped postpone postoperative tumour recurrence']","['parecoxib sodium combined with patient-controlled analgesic fentanyl', 'parecoxibsodium 40 mg (group P) or placebo', 'parecoxib sodium']","['percentages of CD3+, CD4+, CD8+, CD4+/CD8+ T cells, and CD3+CD16+CD56+ (NK) cells', 'overall survival (OS) and disease-free survival (DFS', 'postoperative pain, immune function, and prognosis', 'amount of CD3+ T cells', 'analgesic efficacy', 'flow cytometry (FCM).Visual analogue scale (VAS) scores, total fentanyl consumption, and adverse effects', 'percentages of CD3+, CD4+ T cells, and the ratio of CD4+/CD8', 'VAS scores', 'DFS time', 'Venous blood samples', 'OS time', 'percentages of CD3+ T cells', 'VAS scores at rest and on cough', 'percentages of NK cells', 'postoperative pain and immune function', 'incidence of adverse effects']","[{'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0019144', 'cui_str': 'Hepatectomy'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2239176', 'cui_str': 'Liver Cell Carcinoma, Adult'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0078944', 'cui_str': 'Patient-Controlled Analgesia'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}]","[{'cui': 'C0915144', 'cui_str': 'parecoxib sodium'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0441849', 'cui_str': 'Group P (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0033325', 'cui_str': 'Prognosis'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0016263', 'cui_str': 'Flow Microfluorimetry'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0444255', 'cui_str': 'Venous blood specimen'}, {'cui': 'C0443144', 'cui_str': 'At rest (qualifier value)'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0022688', 'cui_str': 'NK Cells'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",2014.0,0.0561692,"In group C, the amount of CD3+ T cells was lower at T3 compared with T0 (P < .05).","[{'ForeName': 'Run-Dong', 'Initials': 'RD', 'LastName': 'Wang', 'Affiliation': 'Department of Hepatic Surgery, The First Affiliated Hospital of USTC, Hefei, China.'}, {'ForeName': 'Jian-Yu', 'Initials': 'JY', 'LastName': 'Zhu', 'Affiliation': 'Department of Trauma Surgery, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Department of Hepatic Surgery, The First Affiliated Hospital of USTC, Hefei, China.'}, {'ForeName': 'Yong-Sheng', 'Initials': 'YS', 'LastName': 'Ge', 'Affiliation': 'Department of Hepatic Surgery, The First Affiliated Hospital of USTC, Hefei, China.'}, {'ForeName': 'Ge-Liang', 'Initials': 'GL', 'LastName': 'Xu', 'Affiliation': 'Department of Hepatic Surgery, The First Affiliated Hospital of USTC, Hefei, China.'}, {'ForeName': 'Wei-Dong', 'Initials': 'WD', 'LastName': 'Jia', 'Affiliation': 'Department of Hepatic Surgery, The First Affiliated Hospital of USTC, Hefei, China.'}]",Journal of evaluation in clinical practice,['10.1111/jep.13256']
3521,32128634,Health-related quality of life associated with trifluridine/tipiracil in heavily pretreated metastatic gastric cancer: results from TAGS.,"BACKGROUND


In TAGS, an international, double-blind, phase 3 trial, trifluridine/tipiracil significantly improved overall survival and progression-free survival compared with placebo in heavily pretreated metastatic gastric cancer patients. This paper reports pre-specified quality of life (QoL) outcomes for TAGS.
METHODS


Patients were randomized 2:1 to trifluridine/tipiracil (35 mg/m 2  twice daily on days 1-5 and 8-12 of each 28-day cycle) plus best supportive care (BSC) or placebo plus BSC. QoL was evaluated at baseline and at each treatment cycle, using the EORTC QLQ-C30 and EORTC QLQ-STO22 questionnaires; results were considered valid for analysis only if ≥ 10% of patients completed the questionnaires. Key QoL outcomes were mean changes from baseline and time to deterioration in QoL. A post hoc analysis assessed the association between QoL and time to deterioration of Eastern Cooperative Oncology Group performance score (ECOG PS) to ≥ 2.
RESULTS


Of 507 randomized patients, 496 had baseline QoL data available. The analysis cut-off was 6 cycles for trifluridine/tipiracil and 3 cycles for placebo. In both treatment groups, there were no clinically significant deteriorations in the mean QLQ-C30 Global Health Status (GHS) score, or in most subscale scores. In a sensitivity analysis including death and disease progression as events, there was a trend towards trifluridine/tipiracil reducing the risk of deterioration of QoL scores compared with placebo. Deterioration in the GHS score was associated with deterioration in ECOG PS.
CONCLUSION


QoL was maintained in TAGS, and there was a trend towards trifluridine/tipiracil reducing the risk of QoL deterioration compared with placebo. Trial registration ClinicalTrials.gov number: NCT02500043.",2020,"In both treatment groups, there were no clinically significant deteriorations in the mean QLQ-C30 Global Health Status (GHS) score, or in most subscale scores.","['heavily pretreated metastatic gastric cancer patients', 'Patients', 'Of 507 randomized patients, 496 had baseline QoL data available', 'heavily pretreated metastatic gastric cancer']","['placebo', 'trifluridine/tipiracil (35\xa0mg/m 2  twice daily on days 1-5 and 8-12 of each 28-day cycle) plus best supportive care (BSC) or placebo plus BSC', 'trifluridine/tipiracil']","['death and disease progression', 'QoL', 'risk of deterioration of QoL scores', 'overall survival and progression-free survival', 'mean QLQ-C30 Global Health Status (GHS) score, or in most subscale scores', 'pre-specified quality of life (QoL) outcomes']","[{'cui': 'C0278498', 'cui_str': 'Metastatic gastric cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0450381', 'cui_str': '507'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0040987', 'cui_str': 'Trifluridine'}, {'cui': 'C4056441', 'cui_str': 'tipiracil'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0459443', 'cui_str': 'Subscale score (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0034380'}]",507.0,0.549219,"In both treatment groups, there were no clinically significant deteriorations in the mean QLQ-C30 Global Health Status (GHS) score, or in most subscale scores.","[{'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Tabernero', 'Affiliation': ""Vall d'Hebron University Hospital and Institute of Oncology (VHIO), UVic-UCC, IOB-Quiron, Barcelona, Spain. jtabernero@vhio.net.""}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Alsina', 'Affiliation': ""Vall d'Hebron University Hospital and Institute of Oncology (VHIO), UVic-UCC, IOB-Quiron, Barcelona, Spain.""}, {'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Shitara', 'Affiliation': 'National Cancer Center Hospital East, Chiba, Japan.'}, {'ForeName': 'Toshihiko', 'Initials': 'T', 'LastName': 'Doi', 'Affiliation': 'National Cancer Center Hospital East, Chiba, Japan.'}, {'ForeName': 'Mikhail', 'Initials': 'M', 'LastName': 'Dvorkin', 'Affiliation': 'Omsk Regional Clinical Centre of Oncology, Omsk, Russia.'}, {'ForeName': 'Wasat', 'Initials': 'W', 'LastName': 'Mansoor', 'Affiliation': 'The Christie NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Hendrik-Tobias', 'Initials': 'HT', 'LastName': 'Arkenau', 'Affiliation': 'Sarah Cannon Research Institute, London, UK.'}, {'ForeName': 'Aliaksandr', 'Initials': 'A', 'LastName': 'Prokharau', 'Affiliation': 'Minsk City Clinical Oncology Dispensary, Minsk, Belarus.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Ghidini', 'Affiliation': 'Azienda Ospedaliera di Cremona, Cremona, Italy.'}, {'ForeName': 'Catia', 'Initials': 'C', 'LastName': 'Faustino', 'Affiliation': 'Instituto Português de Oncologia do Porto Francisco Gentil, Porto, Portugal.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Gorbunova', 'Affiliation': 'N.N. Blokhin Russian Cancer Research Center, Moscow, Russia.'}, {'ForeName': 'Edvard', 'Initials': 'E', 'LastName': 'Zhavrid', 'Affiliation': 'Alexandrov National Cancer Centre of Belarus, Minsk, Belarus.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Nishikawa', 'Affiliation': 'Osaka National Hospital, Osaka, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Ando', 'Affiliation': 'University of Toyama, Toyama, Japan.'}, {'ForeName': 'Şuayib', 'Initials': 'Ş', 'LastName': 'Yalçın', 'Affiliation': 'Hacettepe University, Ankara, Turkey.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Van Cutsem', 'Affiliation': 'University Hospitals and KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Sabater', 'Affiliation': 'Market Access Department, Servier, Suresnes, France.'}, {'ForeName': 'Donia', 'Initials': 'D', 'LastName': 'Skanji', 'Affiliation': 'Institut de Recherches Internationales Servier, Suresnes, France.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Leger', 'Affiliation': 'Institut de Recherches Internationales Servier, Suresnes, France.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Amellal', 'Affiliation': 'Institut de Recherches Internationales Servier, Suresnes, France.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Ilson', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}]",Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association,['10.1007/s10120-020-01053-9']
3522,30192341,The Effectiveness of Olive Oil in Controlling Morning Inflammatory Pain of Phalanges and Knees Among Women With Rheumatoid Arthritis: A Randomized Clinical Trial.,"PURPOSE


This study aimed to determine the effectiveness of olive oil in controlling morning inflammatory pain of phalanges and knees among women with rheumatoid arthritis.
DESIGN


This is a randomized clinical trial, which was done in Arak, Iran.
METHOD


After selecting 60 women based on a convenience sampling method, they were randomly allocated into five groups. A demographic questionnaire, the Visual Analogue Scale, and the Disease Activity Score 28 were completed. After 12 weeks of interventions, the last two scales were again completed. All data were analyzed using t test, Kruskal-Wallis test, and Friedman test.
RESULTS


The mean age of the women was 40 ± 10.5 years. The result of the Friedman test showed a significant difference (p ≤ .001) among the total mean of groups before and after interventions. The post hoc test (least significant difference [LSD]) showed a significant difference (p ≤ .001) between the mean of Disease Activity Score 28 in the group using olive oil for massaging. Results also showed that there are significant differences (p ≤ .001) among the mean of Visual Analogue Scale rates, among the mean of the number of painful joints, and among the mean of the number of swollen joints after intervention in the five groups.
CONCLUSION


Applying topical extra virgin olive oil, Piroxicam gel, and paraffin oil; dry massaging; and taking routine drugs alone were all effective in controlling rheumatic arthritis manifestations, respectively. Therefore, applying topical extra virgin olive oil for controlling of inflammatory pain of joints in rheumatic arthritis is recommended.
CLINICAL RELEVANCE


In comparison with other medical ointments for RA, olive oil has lower expenditure and is findable in many homes.",2020,The post hoc test (least significant difference [LSD]) showed a significant difference (p ≤ .001) between the mean of Disease Activity Score 28 in the group using olive oil for massaging.,"['60 women based on a convenience sampling method', 'Women With Rheumatoid Arthritis', 'The mean age of the women was 40 ± 10.5 years', 'women with rheumatoid arthritis', 'Phalanges and Knees']","['olive oil', 'topical extra virgin olive oil, Piroxicam gel, and paraffin oil', 'topical extra virgin olive oil', 'Olive Oil']","['mean of Visual Analogue Scale rates', 'mean of Disease Activity Score', 'Visual Analogue Scale, and the Disease Activity Score']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517521', 'cui_str': '10.5'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0222682', 'cui_str': 'Phalanx structure'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}]","[{'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0555061', 'cui_str': 'Virgin (finding)'}, {'cui': 'C0031990', 'cui_str': 'Piroxicam'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C0070062', 'cui_str': 'paraffin oils'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C4706353', 'cui_str': 'Disease Activity Score'}]",60.0,0.0921839,The post hoc test (least significant difference [LSD]) showed a significant difference (p ≤ .001) between the mean of Disease Activity Score 28 in the group using olive oil for massaging.,"[{'ForeName': 'Davood', 'Initials': 'D', 'LastName': 'Hekmatpou', 'Affiliation': 'Arak University of Medical Sciences, Arak, Iran.'}, {'ForeName': 'Sepideh', 'Initials': 'S', 'LastName': 'Mortaji', 'Affiliation': 'Arak University of Medical Sciences, Arak, Iran.'}, {'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Rezaei', 'Affiliation': 'Arak University of Medical Sciences, Arak, Iran.'}, {'ForeName': 'Millad', 'Initials': 'M', 'LastName': 'Shaikhi', 'Affiliation': 'Arak University of Medical Sciences, Arak, Iran.'}]",Rehabilitation nursing : the official journal of the Association of Rehabilitation Nurses,['10.1097/rnj.0000000000000162']
3523,31400513,Targeting pregnancy-related weight gain to reduce disparities in obesity: Baseline results from the Healthy Babies trial.,"BACKGROUND


Obesity affects African American women more than any other group in the US. Pregnancy represents a critical life stage of heightened vulnerability for new or persistent obesity, yet few interventions have been effective in reducing excessive gestational weight gain among African American women. We describe the design and baseline findings of Healthy Babies, a two-arm randomized controlled trial testing a mobile health intervention to minimize excessive gestational weight gain versus usual care in this high risk group.
METHODS


African American women in early pregnancy were recruited from two large obstetric practices as well as Philadelphia Women, Infants, and Children's clinics. Participants randomized to the intervention received behavior change goals, daily text messages with feedback, web-based weight gain graphs, health coaching, and a Facebook support group. Data collection included baseline (<22 weeks' gestation), 36-38 weeks' gestation, and 6-month postpartum anthropometric measures and assessments of demographics, contextual factors and behavioral targets. The primary outcome was prevalence of excessive gestational weight gain.
RESULTS


Among participants at baseline (n = 262), the majority met criteria for obesity (63%), were multiparous (62%), single (77%), and were on average 25.6 ± 5.4 years old with a gestational age of 13.9 ± 4.1 weeks. While 82% completed high school, 61% met criteria for inadequate health literacy. Nearly 20% were food insecure. Eighty-eight percent reported a gestational weight gain goal discordant with Institute of Medicine guidelines. There were no significant differences in baseline characteristics between study arms.
CONCLUSIONS


Participants represent a high-risk group for excessive gestational weight gain with demonstrated need for intervention.",2019,"There were no significant differences in baseline characteristics between study arms.
","['African American women', 'Healthy Babies trial', ""African American women in early pregnancy were recruited from two large obstetric practices as well as Philadelphia Women, Infants, and Children's clinics"", 'Healthy Babies', 'Eighty-eight percent reported a gestational weight gain goal discordant with Institute of Medicine guidelines', 'participants at baseline (n\u202f=\u202f262), the majority met criteria for obesity (63%), were multiparous (62%), single (77%), and were on average 25.6\u202f±\u202f5.4\u202fyears old with a gestational age of 13.9\u202f±\u202f4.1\u202fweeks']","['mobile health intervention to minimize excessive gestational weight gain versus usual care', 'behavior change goals, daily text messages with feedback, web-based weight gain graphs, health coaching, and a Facebook support group']","['6-month postpartum anthropometric measures and assessments of demographics, contextual factors and behavioral targets', 'excessive gestational weight gain', 'prevalence of excessive gestational weight gain']","[{'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0031525', 'cui_str': 'Philadelphia'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C4517898', 'cui_str': '88 (qualifier value)'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1398625', 'cui_str': 'Pregnancy Weight Gain'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0021621', 'cui_str': 'National Academies of Science, Engineering, and Medicine (US) Health and Medicine Division'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0026751', 'cui_str': 'Multiparity'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C4517792', 'cui_str': 'Five point four'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C4517562', 'cui_str': '13.9 (qualifier value)'}, {'cui': 'C4517756', 'cui_str': '4.1'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0442802', 'cui_str': 'Excessive (qualifier value)'}, {'cui': 'C1398625', 'cui_str': 'Pregnancy Weight Gain'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0036606', 'cui_str': 'Support Groups'}]","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0442802', 'cui_str': 'Excessive (qualifier value)'}, {'cui': 'C1398625', 'cui_str': 'Pregnancy Weight Gain'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}]",,0.278138,"There were no significant differences in baseline characteristics between study arms.
","[{'ForeName': 'Sharon J', 'Initials': 'SJ', 'LastName': 'Herring', 'Affiliation': 'Center for Obesity Research and Education, College of Public Health, Temple University, Philadelphia, PA, United States of America; Department of Clinical Sciences, Lewis Katz School of Medicine at Temple University, Philadelphia, PA, United States of America; Department of Obstetrics, Gynecology, and Reproductive Sciences, Lewis Katz School of Medicine at Temple University, Philadelphia, PA, United States of America; Department of Medicine, Lewis Katz School of Medicine at Temple University, Philadelphia, PA, United States of America. Electronic address: herris01@temple.edu.'}, {'ForeName': 'Jessica J', 'Initials': 'JJ', 'LastName': 'Albert', 'Affiliation': 'Center for Obesity Research and Education, College of Public Health, Temple University, Philadelphia, PA, United States of America; Department of Clinical Sciences, Lewis Katz School of Medicine at Temple University, Philadelphia, PA, United States of America.'}, {'ForeName': 'Niesha', 'Initials': 'N', 'LastName': 'Darden', 'Affiliation': 'Center for Obesity Research and Education, College of Public Health, Temple University, Philadelphia, PA, United States of America; Department of Clinical Sciences, Lewis Katz School of Medicine at Temple University, Philadelphia, PA, United States of America.'}, {'ForeName': 'Brooke', 'Initials': 'B', 'LastName': 'Bailer', 'Affiliation': 'Center for Obesity Research and Education, College of Public Health, Temple University, Philadelphia, PA, United States of America; Center for Weight and Eating Disorders, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States of America.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Cruice', 'Affiliation': 'Center for Obesity Research and Education, College of Public Health, Temple University, Philadelphia, PA, United States of America; Department of Clinical Sciences, Lewis Katz School of Medicine at Temple University, Philadelphia, PA, United States of America.'}, {'ForeName': 'Sarmina', 'Initials': 'S', 'LastName': 'Hassan', 'Affiliation': 'Department of Obstetrics, Gynecology, and Reproductive Sciences, Lewis Katz School of Medicine at Temple University, Philadelphia, PA, United States of America.'}, {'ForeName': 'Gary G', 'Initials': 'GG', 'LastName': 'Bennett', 'Affiliation': 'Department of Psychology and Neuroscience, Duke University, Durham, NC, United States of America; Duke Digital Health Science Center, Duke Global Health Institute, Durham, NC, United States of America.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Goetzl', 'Affiliation': 'Department of Obstetrics, Gynecology, and Reproductive Sciences, McGovern Medical School, University of Texas Health Center at Houston, Houston, TX, United States of America.'}, {'ForeName': 'Daohai', 'Initials': 'D', 'LastName': 'Yu', 'Affiliation': 'Department of Clinical Sciences, Lewis Katz School of Medicine at Temple University, Philadelphia, PA, United States of America.'}, {'ForeName': 'Linda M', 'Initials': 'LM', 'LastName': 'Kilby', 'Affiliation': 'Philadelphia Women, Infants and Children Program, Philadelphia, PA, United States of America.'}, {'ForeName': 'Gary D', 'Initials': 'GD', 'LastName': 'Foster', 'Affiliation': 'Center for Obesity Research and Education, College of Public Health, Temple University, Philadelphia, PA, United States of America; Center for Weight and Eating Disorders, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States of America; Weight Watchers International, New York, NY, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105822']
3524,31383231,NightBalance Sleep Position Treatment Device Versus Auto-Adjusting Positive Airway Pressure for Treatment of Positional Obstructive Sleep Apnea.,"STUDY OBJECTIVES


Compare treatment efficacy and objective adherence between the NightBalance sleep position treatment (SPT) device and auto-adjusting positive airway pressure (APAP) in patients with exclusive positional obstructive sleep apnea (ePOSA) defined as a supine apnea-hypopnea index (sAHI) ≥ 2 times the nonsupine AHI (nsAHI) and a nsAHI < 10 events/h.
METHODS


This prospective multicenter randomized crossover trial enrolled treatment naive participants with ePOSA (AHI ≥ 15 events/h and nsAHI < 10 events/h) or (AHI > 10 and < 15 events/h with daytime sleepiness and nsAH < 5 events/h). Polysomnography and objective adherence determination (device data) were performed at the end of each 6-week treatment. Patient device preference was determined at the end of the study.
RESULTS


A total of 117 participants were randomized (58 SPT first, 59 APAP first). Of these, 112 started treatment with the second device (adherence cohort) and 110 completed the study (AHI cohort). The AHI on SPT was higher (mean ± standard deviation, 7.29 ± 6.8 versus 3.71 ± 5.1 events/h,  P  < .001). The mean AHI difference (SPT-APAP) was 3.58 events/h with a one sided 95% confidence interval upper bound of 4.96 events/h (< the prestudy noninferiority margin of 5 events/h). The average nightly adherence (all nights) was greater on SPT (345.3 ± 111.22 versus 286.98 ± 128.9 minutes,  P  < .0001). Participants found the SPT to be more comfortable and easier to use and 53% reported a preference for SPT assuming both devices were equally effective.
CONCLUSIONS


Treatment with SPT resulted in non-inferior treatment efficacy and greater adherence compared to APAP in ePOSA suggesting that SPT is an effective treatment for this group.
CLINICAL TRIAL REGISTRATION


Registry: ClinicalTrials.gov; Title: The POSAtive Study: Study for the Treatment of Positional Obstructive Sleep Apnea; Identifier: NCT03061071; URL: https://clinicaltrials.gov/ct2/show/NCT03061071.",2019,"The AHI on SPT was higher (mean ± standard deviation, 7.29 ± 6.8 versus 3.71 ± 5.1 events/h,  P  < .001).","['Positional Obstructive Sleep Apnea', '117 participants were randomized (58 SPT first, 59 APAP first', '112 started treatment with the second device (adherence cohort) and 110 completed the study (AHI cohort', 'naive participants with ePOSA (AHI ≥ 15 events/h and nsAHI', 'patients with exclusive positional obstructive sleep apnea (ePOSA']","['NightBalance Sleep Position Treatment Device Versus Auto-Adjusting Positive Airway Pressure', 'NightBalance sleep position treatment (SPT) device and auto-adjusting positive airway pressure (APAP', 'SPT']","['Polysomnography and objective adherence determination (device data', 'mean AHI difference (SPT-APAP', 'supine apnea-hypopnea index (sAHI) ≥', 'nonsupine AHI (nsAHI) and a nsAHI', 'average nightly adherence']","[{'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C1561964', 'cui_str': 'Patient Positioning'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}]","[{'cui': 'C0162701', 'cui_str': 'Monitoring, Sleep'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C1148554', 'cui_str': 'determination'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C2111846', 'cui_str': 'Apnea-hypopnea index'}]",117.0,0.0276488,"The AHI on SPT was higher (mean ± standard deviation, 7.29 ± 6.8 versus 3.71 ± 5.1 events/h,  P  < .001).","[{'ForeName': 'Richard B', 'Initials': 'RB', 'LastName': 'Berry', 'Affiliation': 'University of Florida, Gainesville, Florida.'}, {'ForeName': 'Matthew L', 'Initials': 'ML', 'LastName': 'Uhles', 'Affiliation': 'Clayton Sleep Institute, Maplewood, Missouri.'}, {'ForeName': 'Brian K', 'Initials': 'BK', 'LastName': 'Abaluck', 'Affiliation': 'Paoli Hospital Sleep Center, Paoli, Pennsylvania.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Winslow', 'Affiliation': 'Norton Clinical Research Group, Louisville, Kentucky.'}, {'ForeName': 'Paula K', 'Initials': 'PK', 'LastName': 'Schweitzer', 'Affiliation': ""St. Luke's Hospital, Chesterfield, Missouri.""}, {'ForeName': 'Raymond A', 'Initials': 'RA', 'LastName': 'Gaskins', 'Affiliation': 'Med One Sleep, Fayetteville, North Carolina.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Doekel', 'Affiliation': 'Sleep Disorders Center of Alabama, Birmingham, Alabama.'}, {'ForeName': 'Helene A', 'Initials': 'HA', 'LastName': 'Emsellem', 'Affiliation': 'The Center for Sleep and Wake Disorders, Chevy Chase, Maryland.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.7868']
3525,31383235,Effects of Medical Therapy on Mild Obstructive Sleep Apnea in Adult Patients.,"STUDY OBJECTIVES


Patients with obstructive sleep apnea (OSA) have been shown to have high levels of inflammatory markers. Anti-inflammatory treatment with montelukast and intranasal steroids have demonstrated efficacy for mild OSA in children; this has not been fully evaluated in adults. This study investigated the response of mild OSA in adults to anti-inflammatory medical therapy.
METHODS


Adults aged ≥ 21 years with an apnea-hypopnea index (AHI) ≤ 15 events/h on polysomnography (PSG) were recruited to a prospective double-blind, randomized control trial. Patients were treated for 12 weeks with montelukast and fluticasone or placebo. All underwent a pretreatment and posttreatment PSG. Epworth Sleepiness Scale (ESS) score was obtained pretreatment and at 6 and 12 weeks posttreatment.
RESULTS


A total of 26 patients completed the study with 13 in each group. Mean age in the treatment and placebo groups were 58.3 ± 10.3 and 54.8 ± 14 years, respectively. There was no significant difference between groups reporting nasal congestion ( P  = .186), rhinitis ( P  = .666), or snoring ( P  = .177). There was no difference in the pretreatment ESS score ( P  = .077), body mass index ( P  = .173), or AHI ( P  = .535). The posttreatment PSG in the treatment group demonstrated a significant increase in total sleep time ( P  = .02) and percent of stage R sleep ( P  = .05). Neither group showed significant change in AHI. In patients in the treatment group, the 6- and 12-week follow-up ESS scores were not significantly different from pretreatment scores ( P  = .37-.46).
CONCLUSIONS


Intranasal steroids and montelukast did not decrease AHI; however, total sleep time and percent of stage R sleep significantly increased. Self-reported improvement could be explained by observed changes in sleep parameters. Larger prospective studies could help elucidate the effects of medical therapy on adult patients with OSA.
CLINICAL TRIAL REGISTRATION


Registry: ClinicalTrials.gov; Title: Montelukast and Nasa ICS for Treatment of Mild Obstructive Sleep Apnea in Adults; Identifier: NCT01089647; URL: https://clinicaltrials.gov/ct2/show/record/NCT01089647.",2019,The posttreatment PSG in the treatment group demonstrated a significant increase in total sleep time ( P  = .02) and percent of stage R sleep ( P  = .05).,"['Adults aged ≥ 21 years with an apnea-hypopnea index (AHI) ≤ 15 events/h on polysomnography (PSG', 'adults to anti-inflammatory medical therapy', 'Adult Patients', 'mild OSA in children', 'Patients with obstructive sleep apnea (OSA', '26 patients completed the study with 13 in each group', 'adult patients with OSA', 'Mild Obstructive Sleep Apnea in Adults']","['Title: Montelukast and Nasa ICS', 'montelukast and fluticasone or placebo', 'placebo', 'Medical Therapy', 'montelukast and intranasal steroids']","['nasal congestion', 'total sleep time and percent of stage R sleep', 'stage R sleep', 'Epworth Sleepiness Scale (ESS) score', 'total sleep time', 'body mass index', 'pretreatment ESS score', 'AHI', 'Mild Obstructive Sleep Apnea']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2111846', 'cui_str': 'Apnea-hypopnea index'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0162701', 'cui_str': 'Monitoring, Sleep'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0298130', 'cui_str': 'montelukast'}, {'cui': 'C0242776', 'cui_str': 'NASA'}, {'cui': 'C0082607', 'cui_str': 'fluticasone'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}]","[{'cui': 'C0027424', 'cui_str': 'Nasal congestion (finding)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C4706348', 'cui_str': 'Epworth Sleepiness Scale score (observable entity)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}]",,0.045252,The posttreatment PSG in the treatment group demonstrated a significant increase in total sleep time ( P  = .02) and percent of stage R sleep ( P  = .05).,"[{'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Smith', 'Affiliation': ""Division of Pediatric Otolaryngology, Department of Otolaryngology-Head and Neck Surgery, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Sarber', 'Affiliation': ""Division of Pediatric Otolaryngology, Department of Otolaryngology-Head and Neck Surgery, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'Charlene P', 'Initials': 'CP', 'LastName': 'Spiceland', 'Affiliation': 'College School of Business, Simmons University, Boston, Massachusetts.'}, {'ForeName': 'Stacey L', 'Initials': 'SL', 'LastName': 'Ishman', 'Affiliation': ""Division of Pediatric Otolaryngology, Department of Otolaryngology-Head and Neck Surgery, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'Dianne M', 'Initials': 'DM', 'LastName': 'Augelli', 'Affiliation': 'Weill Medical College, Cornell University, New York, New York.'}, {'ForeName': 'Ann M', 'Initials': 'AM', 'LastName': 'Romaker', 'Affiliation': 'Department of Pulmonary, Critical Care and Sleep Medicine, University of Cincinnati College of Medicine, Cincinnati, Ohio.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.7876']
3526,31786338,"An exploratory randomized sub-study of light-to-moderate intensity exercise on cognitive function, depression symptoms and inflammation in older adults with heart failure.","OBJECTIVE


Almost half of patients with heart failure (HF) have cognitive impairment. While exercise relates to better cognitive health, a hallmark of HF is exercise intolerance. The study objective was to explore whether light-to-moderate exercise improves cognitive function in patients with HF.
METHODS


This was an exploratory parallel design study of 69 patients with symptomatic HF (mean age = 65, SD = 10), recruited from VA and University of California, San Diego Healthcare Systems. Participants were randomized to Tai Chi (TC) (n = 24), resistance band (RB) exercise (n = 22) or treatment as usual (TAU) (n = 23). The primary outcome was change in Montreal Cognitive Assessment (MoCA) scores. We further explored if changes in Beck Depression Inventory - IA (BDI-IA) scores or inflammation biomarkers, CRP, TNFα and IL-6 related to altered cognitive function.
RESULTS


There was a fixed effect of group for MoCA scores changes (F = 8.07, p = .001). TC and RB groups had greater MoCA score increases versus TAU, but no differences were found between TC and RB. Depression symptom changes predicted altered MoCA scores (ΔR 2  = 0.15, Β = -0.413, p = .001). However, group did not interact with depression symptom levels for MoCA alterations (p = .392). Changes in CRP levels predicted MoCA scores (ΔR 2  = 0.078, Β = -0.283, p = .01), but group did not interact with CRP levels for MoCA alterations (p = .689).
CONCLUSIONS


Light-to-moderate exercises, TC and RB may improve cognitive function. However, the mechanisms remain unclear. ClinicalTrials.gov: NCT01625819.",2020,"There was a fixed effect of group for MoCA scores changes (F = 8.07, p = .001).","['patients with heart failure (HF', 'older adults with heart failure', 'patients with HF', '69 patients with symptomatic HF']","['TC and RB', 'resistance band (RB) exercise (n\xa0=\xa022) or treatment as usual (TAU) ', 'light-to-moderate exercise', 'light-to-moderate intensity exercise', 'Tai Chi (TC']","['MoCA score', 'MoCA scores changes', 'Changes in CRP levels predicted MoCA scores', 'cognitive function', 'MoCA scores', 'cognitive function, depression symptoms and inflammation', 'Beck Depression Inventory - IA (BDI-IA) scores or inflammation biomarkers, CRP, TNFα and IL-6', 'Montreal Cognitive Assessment (MoCA) scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}]","[{'cui': 'C0185014', 'cui_str': 'Banding'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0376403', 'cui_str': 'Taiji'}]","[{'cui': 'C4721272', 'cui_str': 'Montreal cognitive assessment score'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}]",69.0,0.064532,"There was a fixed effect of group for MoCA scores changes (F = 8.07, p = .001).","[{'ForeName': 'Laura S', 'Initials': 'LS', 'LastName': 'Redwine', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, CA, USA; College of Nursing, University of South Florida, Tampa, FL, USA. Electronic address: lredwine@usf.edu.'}, {'ForeName': 'Meredith A', 'Initials': 'MA', 'LastName': 'Pung', 'Affiliation': 'Department of Family Medicine and Public Health, University of California, San Diego, CA, USA; College of Nursing, University of South Florida, Tampa, FL, USA.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Wilson', 'Affiliation': 'Department of Family Medicine and Public Health, University of California, San Diego, CA, USA.'}, {'ForeName': 'Katherine J', 'Initials': 'KJ', 'LastName': 'Bangen', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, CA, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Delano-Wood', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, CA, USA.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Hurwitz', 'Affiliation': 'Psychology Department, University of Miami, USA.'}]",Journal of psychosomatic research,['10.1016/j.jpsychores.2019.109883']
3527,32106832,"Efficacy and safety of bupropion in cancer-related fatigue, a randomized double blind placebo controlled clinical trial.","BACKGROUND AND OBJECTIVES


Cancer-related fatigue (CRF) is one of the most prevalent complications experienced by cancer patients during and after the process of treatment. Despite conducting a lot of studies, there is no approved therapy to help manage CRF. This study aims to investigate the efficacy of bupropion on CRF.
MATERIALS AND METHODS


In this double-blind randomized placebo-controlled clinical trial, a total of 30 eligible cancer patients suffering from fatigue were randomly divided into two groups (15 patients in each group). Bupropion was administered 75 mg/day for the first three days and 150 mg/day (divided in two doses) till the end of the study at week 6. Fatigue as the primary outcome was measured by BFI (Brief Fatigue Inventory) and FACIT-Fatigue (Functional Assessment of Chronic Illness Therapy) scales. Secondary outcomes included HADS (Hospital Anxiety and Depression Scale) and performance status (PS) measured by Karnofsky and ECOG (Eastern Cooperative Oncology Group) scales. Assessments were done at baseline, end of the second and sixth week.
RESULTS


There was no significant difference between placebo and bupropion at baseline and the end of second week. Significant difference was seen between two groups at the end of week six (P = 0.006 based on BFI) in favor of bupropion. In-group assessment showed improvement in fatigue levels in both groups during study time (P = 0.000 based on BFI for both bupropion and placebo). Secondary outcomes (e.g., HADS and PS) were not different at baseline and the end of second week. However, at the end of week six, the difference was significant in favor of bupropion.
CONCLUSION


A six-week trial of bupropion reduces the CRF and improves the PS of cancer patients.
TRIAL REGISTRATION


Current Controlled Trials IRCT20090613002027N12, registration date: 2018-06-01.",2020,Significant difference was seen between two groups at the end of week six (P = 0.006 based on BFI) in favor of bupropion.,"['30 eligible cancer patients suffering from fatigue', 'cancer-related fatigue']","['placebo', 'Bupropion', 'placebo and bupropion', 'bupropion']","['HADS (Hospital Anxiety and Depression Scale) and performance status (PS) measured by Karnofsky and ECOG (Eastern Cooperative Oncology Group) scales', 'Efficacy and safety', 'Fatigue', 'BFI (Brief Fatigue Inventory) and FACIT-Fatigue (Functional Assessment of Chronic Illness Therapy) scales', 'HADS and PS', 'fatigue levels']","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C4274302', 'cui_str': 'Fatigue associated with malignant neoplastic disease'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0085208', 'cui_str': 'Bupropion'}]","[{'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0430797', 'cui_str': 'Intracranial EEG'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0008679', 'cui_str': 'Chronic Illness'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",30.0,0.402149,Significant difference was seen between two groups at the end of week six (P = 0.006 based on BFI) in favor of bupropion.,"[{'ForeName': 'Ebrahim', 'Initials': 'E', 'LastName': 'Salehifar', 'Affiliation': 'Pharmaceutical Research Center, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran. Esalehifar@mazums.ac.ir.'}, {'ForeName': 'Saeid', 'Initials': 'S', 'LastName': 'Azimi', 'Affiliation': 'Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Ghasem', 'Initials': 'G', 'LastName': 'Janbabai', 'Affiliation': 'Gastrointestinal Cancer Research Center, Faculty of Medicine, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Ehsan', 'Initials': 'E', 'LastName': 'Zaboli', 'Affiliation': 'Gastrointestinal Cancer Research Center, Faculty of Medicine, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Narjes', 'Initials': 'N', 'LastName': 'Hendouei', 'Affiliation': 'Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Saghafi', 'Affiliation': 'Faculty of Pharmacy, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Samaneh', 'Initials': 'S', 'LastName': 'Borhani', 'Affiliation': 'Emam Khomeini Hospital, Mazandaran University of Medical Sciences, Sari, Iran.'}]",BMC cancer,['10.1186/s12885-020-6618-9']
3528,32122219,Interleukin-1 Blockade Inhibits the Acute Inflammatory Response in Patients With ST-Segment-Elevation Myocardial Infarction.,"Background ST-segment-elevation myocardial infarction is associated with an intense acute inflammatory response and risk of heart failure. We tested whether interleukin-1 blockade with anakinra significantly reduced the area under the curve for hsCRP (high sensitivity C-reactive protein) levels during the first 14 days in patients with ST-segment-elevation myocardial infarction (VCUART3 [Virginia Commonwealth University Anakinra Remodeling Trial 3]). Methods and Results We conducted a randomized, placebo-controlled, double-blind, clinical trial in 99 patients with ST-segment-elevation myocardial infarction in which patients were assigned to 2 weeks treatment with anakinra once daily (N=33), anakinra twice daily (N=31), or placebo (N=35). hsCRP area under the curve was significantly lower in patients receiving anakinra versus placebo (median, 67 [interquartile range, 39-120] versus 214 [interquartile range, 131-394] mg·day/L;  P <0.001), without significant differences between the anakinra arms. No significant differences were found between anakinra and placebo groups in the interval changes in left ventricular end-systolic volume (median, 1.4 [interquartile range, -9.8 to 9.8] versus -3.9 [interquartile range, -15.4 to 1.4] mL;  P =0.21) or left ventricular ejection fraction (median, 3.9% [interquartile range, -1.6% to 10.2%] versus 2.7% [interquartile range, -1.8% to 9.3%];  P =0.61) at 12 months. The incidence of death or new-onset heart failure or of death and hospitalization for heart failure was significantly lower with anakinra versus placebo (9.4% versus 25.7% [ P =0.046] and 0% versus 11.4% [ P =0.011], respectively), without difference between the anakinra arms. The incidence of serious infection was not different between anakinra and placebo groups (14% versus 14%;  P =0.98). Injection site reactions occurred more frequently in patients receiving anakinra (22%) versus placebo (3%;  P =0.016). Conclusions In patients presenting with ST-segment-elevation myocardial infarction, interleukin-1 blockade with anakinra significantly reduces the systemic inflammatory response compared with placebo. Clinical Trial Registration URL: https://www.clinicaltrials.gov/. Unique identifier: NCT01950299.",2020,"No significant differences were found between anakinra and placebo groups in the interval changes in left ventricular end-systolic volume (median, 1.4 [interquartile range, -9.8 to 9.8] versus -3.9 [interquartile range, -15.4 to 1.4] mL;  P =0.21) or left ventricular ejection fraction (median, 3.9% [interquartile range, -1.6% to 10.2%] versus 2.7% [interquartile range, -1.8% to 9.3%];  P =0.61) at 12 months.","['Patients With ST-Segment-Elevation Myocardial Infarction', '99 patients with ST-segment-elevation myocardial infarction in which patients']","['placebo', 'anakinra once daily (N=33), anakinra twice daily (N=31), or placebo', 'Interleukin-1 Blockade']","['systemic inflammatory response', 'interval changes in left ventricular end-systolic volume', 'left ventricular ejection fraction', 'Injection site reactions', 'incidence of serious infection', 'hsCRP area under the curve', 'incidence of death or new-onset heart failure or of death and hospitalization for heart failure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1536220', 'cui_str': 'ST Elevated Myocardial Infarction'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0245109', 'cui_str': 'anakinra'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0021755', 'cui_str': 'T Helper Factor'}, {'cui': 'C3540676', 'cui_str': 'Blockade'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0080308', 'cui_str': 'Ventricular End-Systolic Volume'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0151735', 'cui_str': 'Injection Site Adverse Event'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}]",99.0,0.692654,"No significant differences were found between anakinra and placebo groups in the interval changes in left ventricular end-systolic volume (median, 1.4 [interquartile range, -9.8 to 9.8] versus -3.9 [interquartile range, -15.4 to 1.4] mL;  P =0.21) or left ventricular ejection fraction (median, 3.9% [interquartile range, -1.6% to 10.2%] versus 2.7% [interquartile range, -1.8% to 9.3%];  P =0.61) at 12 months.","[{'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Abbate', 'Affiliation': 'Virginia Commonwealth University Pauley Heart Center MedStar Washington Hospital Center Washington DC.'}, {'ForeName': 'Cory R', 'Initials': 'CR', 'LastName': 'Trankle', 'Affiliation': 'Virginia Commonwealth University Pauley Heart Center MedStar Washington Hospital Center Washington DC.'}, {'ForeName': 'Leo F', 'Initials': 'LF', 'LastName': 'Buckley', 'Affiliation': 'Department of Pharmacotherapy and Outcomes Science MedStar Washington Hospital Center Washington DC.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Lipinski', 'Affiliation': 'Medstar Heart and Vascular Institute MedStar Washington Hospital Center Washington DC.'}, {'ForeName': 'Darryn', 'Initials': 'D', 'LastName': 'Appleton', 'Affiliation': 'Virginia Cardiovascular Specialists Richmond VA.'}, {'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Kadariya', 'Affiliation': 'Virginia Commonwealth University Pauley Heart Center MedStar Washington Hospital Center Washington DC.'}, {'ForeName': 'Justin M', 'Initials': 'JM', 'LastName': 'Canada', 'Affiliation': 'Virginia Commonwealth University Pauley Heart Center MedStar Washington Hospital Center Washington DC.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Carbone', 'Affiliation': 'Virginia Commonwealth University Pauley Heart Center MedStar Washington Hospital Center Washington DC.'}, {'ForeName': 'Charlotte S', 'Initials': 'CS', 'LastName': 'Roberts', 'Affiliation': 'Virginia Commonwealth University Pauley Heart Center MedStar Washington Hospital Center Washington DC.'}, {'ForeName': 'Nayef', 'Initials': 'N', 'LastName': 'Abouzaki', 'Affiliation': 'Virginia Commonwealth University Pauley Heart Center MedStar Washington Hospital Center Washington DC.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Melchior', 'Affiliation': 'Virginia Commonwealth University Pauley Heart Center MedStar Washington Hospital Center Washington DC.'}, {'ForeName': 'Sanah', 'Initials': 'S', 'LastName': 'Christopher', 'Affiliation': 'Virginia Commonwealth University Pauley Heart Center MedStar Washington Hospital Center Washington DC.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Turlington', 'Affiliation': 'Virginia Commonwealth University Pauley Heart Center MedStar Washington Hospital Center Washington DC.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Mueller', 'Affiliation': 'Virginia Commonwealth University Pauley Heart Center MedStar Washington Hospital Center Washington DC.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Garnett', 'Affiliation': 'Virginia Cardiovascular Specialists Richmond VA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Thomas', 'Affiliation': 'Virginia Commonwealth University Pauley Heart Center MedStar Washington Hospital Center Washington DC.'}, {'ForeName': 'Roshanak', 'Initials': 'R', 'LastName': 'Markley', 'Affiliation': 'Virginia Commonwealth University Pauley Heart Center MedStar Washington Hospital Center Washington DC.'}, {'ForeName': 'George F', 'Initials': 'GF', 'LastName': 'Wohlford', 'Affiliation': 'Department of Pharmacotherapy and Outcomes Science MedStar Washington Hospital Center Washington DC.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Puckett', 'Affiliation': 'Virginia Commonwealth University Pauley Heart Center MedStar Washington Hospital Center Washington DC.'}, {'ForeName': 'Horacio', 'Initials': 'H', 'LastName': 'Medina de Chazal', 'Affiliation': 'Virginia Commonwealth University Pauley Heart Center MedStar Washington Hospital Center Washington DC.'}, {'ForeName': 'Juan G', 'Initials': 'JG', 'LastName': 'Chiabrando', 'Affiliation': 'Virginia Commonwealth University Pauley Heart Center MedStar Washington Hospital Center Washington DC.'}, {'ForeName': 'Edoardo', 'Initials': 'E', 'LastName': 'Bressi', 'Affiliation': 'Virginia Commonwealth University Pauley Heart Center MedStar Washington Hospital Center Washington DC.'}, {'ForeName': 'Marco Giuseppe', 'Initials': 'MG', 'LastName': 'Del Buono', 'Affiliation': 'Virginia Commonwealth University Pauley Heart Center MedStar Washington Hospital Center Washington DC.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Schatz', 'Affiliation': 'Virginia Commonwealth University Pauley Heart Center MedStar Washington Hospital Center Washington DC.'}, {'ForeName': 'Chau', 'Initials': 'C', 'LastName': 'Vo', 'Affiliation': 'Virginia Commonwealth University Pauley Heart Center MedStar Washington Hospital Center Washington DC.'}, {'ForeName': 'Dave L', 'Initials': 'DL', 'LastName': 'Dixon', 'Affiliation': 'Virginia Commonwealth University Pauley Heart Center MedStar Washington Hospital Center Washington DC.'}, {'ForeName': 'Giuseppe G', 'Initials': 'GG', 'LastName': 'Biondi-Zoccai', 'Affiliation': ""Department of Medico-Surgical Sciences and Biotechnologies Sapienza' University of Rome Latina Italy.""}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Kontos', 'Affiliation': 'Virginia Commonwealth University Pauley Heart Center MedStar Washington Hospital Center Washington DC.'}, {'ForeName': 'Benjamin W', 'Initials': 'BW', 'LastName': 'Van Tassell', 'Affiliation': 'Virginia Commonwealth University Pauley Heart Center MedStar Washington Hospital Center Washington DC.'}]",Journal of the American Heart Association,['10.1161/JAHA.119.014941']
3529,32120445,Less Blood Loss by Earlier Oxytocin Infusion in Cesarean Sections? A Randomized Controlled Trial.,"PURPOSE


The aim of our study was to evaluate the positive effect of starting an IV oxytocin infusion early before uterine incision on intraoperative blood loss.
METHODS


A total of 101 women between 18-40 years who underwent a primary elective cesarean section (CS) were included in this randomized controlled trial. The patients were divided into two groups. In Group I (n=51), oxytocin infusion was administered immediately after incision of the visceral peritoneum during CS. In Group II (n=50), infusion was administered immediately after clamping the umbilical cord. The primary outcome was the mean volume of blood loss during CS. The secondary outcomes included the mean reduction in hemoglobin and hematocrit levels, need for additional uterotonics and hemostatic uterine sutures, blood transfusion, post-operative pain score, and additional surgical procedures.
RESULTS


There were statistical significant differences either in the change of the hemoglobin concentration (1.27±0.75 vs.1.74±0.81; p<0.01) or in the change of hematocrit concentration (3.89±2.24 vs. 5.41±2.93; p<0.01). Intraoperative blood loss was significantly lower in Group I when compared to Group II (475.86±150.11 vs. 605.1±203.2; p<0.01).
CONCLUSIONS


Our findings suggest that the starting IV oxytocin infusion early before uterine incision reduces intraoperative blood loss. This could be effective to replace starting IV oxytocin infusion late after umbilical cord clamping or delivery of the placenta.
EINLEITUNG


Das Ziel unserer Studie war es. die positive Wirkung der beginnenden IV Oxytocin-Infusion früh vor der Uterusinzision auf den intraoperativen Blutverlust zu bewerten.
MATERIAL UND METHODIK


In diese randomisierte kontrollierte Studie wurden insgesamt 101 Frauen zwischen 18 und 40 Jahren eingeschlossen, die sich einem primären elektiven Kaiserschnitt unterzogen hatten. Die Patienten wurden in 2 Gruppen eingeteilt. Gruppe I (n=51); Die Oxytocin-Infusion wurde unmittelbar nach der Inzision des viszeralen Peritoneums während der CS verabreicht. Gruppe II (n=50); Die Infusion wurde unmittelbar nach dem Klemmen der Nabelschnur verabreicht. Das primäre Ergebnis war das mittlere Blutverlustvolumen während der CS. Zu den sekundären Ergebnissen gehörte die mittlere Verringerung der Hämoglobin- und Hämatokritwerte, Bedarf an zusätzlichen Uterotonika und hämostatischen Uterusnähten, Bluttransfusion, postoperativer Schmerzscore und zusätzliche chirurgische Eingriffe.
ERGEBNISSE


Es gab statistisch signifikante Unterschiede zwischen der Änderung der Hämoglobinkonzentration 1,27±0,75 vs.1,74±0,81; p<0,01) oder der Änderung der Hämatokritkonzentration(3,89±2,24 vs. 5,41±2,93; p<0,01). Der intraoperative Blutverlust war in Gruppe I im Vergleich zu Gruppe II signifikant geringer (475,86±150,11 vs. 605,1±203,2; p<0,01).
DISKUSSION


Unsere Ergebnisse legen nahe, dass die beginnende intravenöse Oxytocin-Infusion früh vor der Uterusinzision den intraoperativen Blutverlust verringert. Dies könnte wirksam sein, um eine beginnende intravenöse Oxytocin-Infusion zu einem späten Zeitpunkt nach dem Klemmen der Nabelschnur oder der Abgabe der Plazenta zu ersetzen.",2020,"Intraoperative blood loss was significantly lower in Group I when compared to Group II (475.86±150.11 vs. 605.1±203.2; p<0.01).
","['Gruppe I (n=51', '101 women between 18-40 years who underwent a primary elective cesarean section (CS', '101 Frauen']","['oxytocin infusion', 'Die Infusion wurde unmittelbar nach dem Klemmen der Nabelschnur verabreicht', 'Oxytocin', 'Gruppe II', 'oxytocin', 'Oxytocin-Infusion zu einem späten', 'Oxytocin-Infusion wurde unmittelbar nach der Inzision']","['hematocrit concentration', 'intraoperative blood loss', 'Intraoperative blood loss', 'mean volume of blood loss', 'hemoglobin concentration', 'mean reduction in hemoglobin and hematocrit levels, need for additional uterotonics and hemostatic uterine sutures, blood transfusion, post-operative pain score, and additional surgical procedures']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C1546956', 'cui_str': 'Dead (finding)'}]","[{'cui': 'C0518014', 'cui_str': 'Hematocrit - finding'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C3653843', 'cui_str': 'Other uterotonics in ATC'}, {'cui': 'C0019120', 'cui_str': 'Hemostatics'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C1273858', 'cui_str': 'Transfusion Medicine'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}]",101.0,0.147247,"Intraoperative blood loss was significantly lower in Group I when compared to Group II (475.86±150.11 vs. 605.1±203.2; p<0.01).
","[{'ForeName': 'Taha', 'Initials': 'T', 'LastName': 'Takmaz', 'Affiliation': 'Obstetrics and Gynecology, Bezmialem Vakif University, Istanbul, Turkey.'}, {'ForeName': 'Pinar', 'Initials': 'P', 'LastName': 'Ozcan', 'Affiliation': 'Obstetrics and Gynecology, Bezmialem Vakif University, Istanbul, Turkey.'}, {'ForeName': 'Osman', 'Initials': 'O', 'LastName': 'Sevket', 'Affiliation': 'Obstetrics and Gynecology, Bezmialem Vakif University, Istanbul, Turkey.'}, {'ForeName': 'Ayse Filiz Gokmen', 'Initials': 'AFG', 'LastName': 'Karasu', 'Affiliation': 'Obstetrics and Gynecology, Bezmialem Vakif University, Istanbul, Turkey.'}, {'ForeName': 'Sevde Havva', 'Initials': 'SH', 'LastName': 'Islek', 'Affiliation': 'Obstetrics and Gynecology, Bezmialem Vakif University, Istanbul, Turkey.'}, {'ForeName': 'Belfin Nur Arici', 'Initials': 'BNA', 'LastName': 'Halici', 'Affiliation': 'Obstetrics and Gynecology, Bezmialem Vakif University, Istanbul, Turkey.'}]",Zeitschrift fur Geburtshilfe und Neonatologie,['10.1055/a-1108-2017']
3530,32124462,Learned pacing for adults with chronic pain: A randomised controlled trial feasibility study.,"INTRODUCTION


Chronic pain can significantly impact on an individual's occupational performance and quality of life. Pacing is a pain management strategy regularly used in occupational therapy practice; however, evidence for its effectiveness has not been established.
OBJECTIVES


To determine the feasibility of a future randomised controlled trial to investigate the effectiveness of a learned pacing intervention on occupational performance and satisfaction for adults with chronic pain.
METHODS


A randomised controlled trial feasibility study was conducted with participants randomly assigned to a learned pacing intervention or a waitlist control group. The primary outcome measure was the Canadian Occupational Performance Measure.
RESULTS


One hundred and twenty-eight people were screened for eligibility over 36 weeks, with 74 people invited to participate. Twelve were randomly assigned, eight to the learned pacing group and four to the control group. Those receiving the learned pacing intervention had clinically important changes in occupational performance and occupational satisfaction. Participants in the waitlist control group also had clinically important changes in occupational satisfaction. The method design was deemed feasible; however, several improvements would increase the rate of participant recruitment and reduce attrition. Recruitment from multiple sites is required to obtain an adequate sample size of 60.
CONCLUSION


Undertaking a future randomised controlled trial is feasible and warranted to establish the effectiveness of a learned pacing intervention on occupational performance and satisfaction for adults with chronic pain.",2020,Participants in the waitlist control group also had clinically important changes in occupational satisfaction.,"['One hundred and twenty-eight people were screened for eligibility over 36\xa0weeks, with 74 people invited to participate', 'adults with chronic pain']","['waitlist control group', 'learned pacing intervention', 'Learned pacing']","['occupational performance and occupational satisfaction', 'occupational satisfaction', 'rate of participant recruitment and reduce attrition', 'Canadian Occupational Performance Measure', 'occupational performance and satisfaction']","[{'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0562458', 'cui_str': 'Pacing up and down (finding)'}]","[{'cui': 'C0521127', 'cui_str': 'Occupational (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C2585956', 'cui_str': 'Canadian occupational performance measure (assessment scale)'}]",128.0,0.14664,Participants in the waitlist control group also had clinically important changes in occupational satisfaction.,"[{'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Guy', 'Affiliation': 'Community Based Rehabilitation Department, Western Health, St. Albans, Vic., Australia.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'McKinstry', 'Affiliation': 'La Trobe Rural Health School, La Trobe University, Flora Hill, Vic., Australia.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Bruce', 'Affiliation': 'School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Vic., Australia.'}]",Australian occupational therapy journal,['10.1111/1440-1630.12653']
3531,31696603,"A randomized, double-blind, placebo-controlled, pharmacokinetic and pharmacodynamic study of a fixed-dose combination of phentermine/topiramate in adolescents with obesity.","AIMS


To assess the pharmacokinetic (PK) and pharmacodynamic characteristics of VI-0521, a fixed-dose combination of immediate-release phentermine (PHEN) and extended-release topiramate (TPM) in adolescents aged 12 to 17 years with obesity, and to report weight loss and adverse events using this drug combination.
MATERIALS AND METHODS


This was a multicentre, randomized, double-blind, parallel-design, placebo-controlled study in adolescents with obesity. A total of 42 adolescents were randomly assigned in a 1:1:1 ratio to placebo, or to a mid-dose (PHEN/TPM 7.5 mg/46 mg), or a top-dose (PHEN/TPM 15 mg/92 mg) of VI-0521. A total of 26 adolescents were included in the PK analysis (14 from the mid-dose group and 12 from the top-dose group).
RESULTS


On day 56, arithmetic means of terminal elimination half-life, apparent clearance (CL/F) and apparent central volume of distribution (Vc/F) were consistent across dose levels for both PHEN and TPM. Arithmetic means of CL/F and Vc/F for PHEN and TPM administered as a combination in adolescents with obesity were within 10% to 30% of those previously assessed in adults with obesity enrolled in phase II and III studies. A higher proportion of adolescents in both the mid- and top-dose groups (13.3% and 50.0%, respectively) compared with placebo (0.0%) reached ≥5% weight loss at day 56. The least squares (LS) mean change in systolic blood pressure from baseline to day 56 was -5.2 mmHg for the placebo group, -2.5 mmHg for the mid-dose group, and - 5.5 mmHg for the top-dose group. The LS mean change in diastolic blood pressure from baseline to day 56 was -2.4 mmHg for the placebo group, +3.8 mmHg for the mid-dose group, and + 2.0 mmHg for the top-dose group. Participants in the top-dose group had increases in heart rate from baseline of 4.1 bpm, while participants in the mid-dose group experienced a mean decrease in heart rate of 4.5 bpm at day 56. Both PHEN/TPM dose combinations were safe and well tolerated.
CONCLUSIONS


Treatment of adolescents with obesity using a fixed-dose combination of PHEN/TPM for 8 weeks resulted in exposure to PHEN and TPM that was comparable to that observed in adults, statistically significant weight loss, and a tolerable safety profile. These data indicate that both mid- and top-dose levels are appropriate for longer-term safety and efficacy studies in adolescents.",2020,"The least square (LS) mean change in systolic blood pressure from baseline to Week 56 was -5.2 mmHg for the placebo group, -2.5 ","['42 adolescents', 'adolescents with obesity', 'adolescents', 'Adolescents with Obesity', '26 adolescents were included in the PK analysis (14 from the mid-dose group and 12 from the top-dose group', 'adolescents 12 to 17\u2009years of age with obesity', 'adolescents with obesity were within 10%-30% of those previously assessed in adults with obesity enrolled in Phase II and III studies']","['Placebo', 'placebo, mid-dose (PHEN/TPM 7.5 mg/46 mg), or top-dose (PHEN/TPM 15 mg/92 mg) of VI-0521', 'VI-0521, a fixed-dose combination of immediate-release phentermine (PHEN) and extended-release (ER) topiramate (TPM', 'CL/F and Vc/F for PHEN and TPM', 'phentermine/topiramate', 'placebo', 'Phentermine/Topiramate', 'PHEN/TPM']","['arithmetic means of terminal elimination half-life (T ½  ), apparent clearance (CL/F) and apparent volume of distribution (Vc/F', 'Weight loss and adverse events', 'diastolic blood pressure (DBP', 'weight loss', 'least square (LS) mean change in systolic blood pressure', 'tolerable safety profile', 'safe and well tolerated', 'heart rate']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4517859', 'cui_str': 'Seven point five'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0031447', 'cui_str': 'Phentermine'}, {'cui': 'C0076829', 'cui_str': 'topiramate'}, {'cui': 'C3475162', 'cui_str': 'Phentermine / topiramate'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0018517', 'cui_str': 'Halflife'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0023189', 'cui_str': 'Least Squares'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}]",42.0,0.300685,"The least square (LS) mean change in systolic blood pressure from baseline to Week 56 was -5.2 mmHg for the placebo group, -2.5 ","[{'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Hsia', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, Louisiana, United States.'}, {'ForeName': 'Nathalie H', 'Initials': 'NH', 'LastName': 'Gosselin', 'Affiliation': 'Certara USA, Inc, Princeton, New Jersey.'}, {'ForeName': 'Jenna', 'Initials': 'J', 'LastName': 'Williams', 'Affiliation': ""Cincinnati Children's Hospital/University of Cincinnati, Cincinnati, Ohio, United States.""}, {'ForeName': 'Nada', 'Initials': 'N', 'LastName': 'Farhat', 'Affiliation': 'Certara USA, Inc, Princeton, New Jersey.'}, {'ForeName': 'J F', 'Initials': 'JF', 'LastName': 'Marier', 'Affiliation': 'Certara USA, Inc, Princeton, New Jersey.'}, {'ForeName': 'Winnie', 'Initials': 'W', 'LastName': 'Shih', 'Affiliation': 'Vivus, Inc, Campbell, California.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Peterson', 'Affiliation': 'Vivus, Inc, Campbell, California.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Siegel', 'Affiliation': ""Cincinnati Children's Hospital/University of Cincinnati, Cincinnati, Ohio, United States.""}]","Diabetes, obesity & metabolism",['10.1111/dom.13910']
3532,31709738,"Improved glycaemic variability and time in range with dapagliflozin versus gliclazide modified release among adults with type 2 diabetes, evaluated by continuous glucose monitoring: A 12-week randomized controlled trial.","AIMS


To evaluate whether there is a difference between the effects of dapagliflozin and gliclazide modified release (MR) on glycaemic variability (GV) and glycaemic control, as assessed by continuous glucose monitoring (CGM), in individuals with uncontrolled type 2 diabetes.
MATERIALS AND METHODS


This randomized, open-label, active-controlled study was conducted in individuals with uncontrolled type 2 diabetes who were drug-naïve or on steady-dose metformin monotherapy. Participants were treated once daily with 10 mg dapagliflozin or 120 mg gliclazide MR. CGM and GV index calculations were performed at baseline and after 12 weeks.
RESULTS


In total, 97 participants (age 57.9 ± 8.7 years, 50.5% men, baseline glycated haemoglobin 63 ± 9.8 mmol/mol [7.9 ± 0.9%]) were randomized, and 94 completed the 12-week protocol. Intention-to-treat (ITT) and per-protocol (PP) analyses showed that the reduction in GV, as measured by the mean amplitude of glycaemic excursions, was superior in the dapagliflozin group versus the gliclazide MR group (-0.9 mmol/L [95% CI -1.5, -0.4] vs -0.2 mmol/L [95% CI -0.6, 0.3]; P = 0.030 [ITT]). The reductions in GV estimated by the coefficient of variation and SD were greater in the dapagliflozin group. Moreover, dapagliflozin increased the glucose time in range (TIR; 3.9-10 mmol/L) by 24.9% (95% CI 18.6, 31.2) vs. 17.4% (95% CI 11.6, 23.3) in the gliclazide MR group (P = 0.089 [ITT]; P = 0.041 [PP]).
CONCLUSIONS


Dapagliflozin improved GV and increased TIR more efficiently than gliclazide MR in individuals with type 2 diabetes over 12 weeks, as demonstrated by CGM.",2020,The reductions in GV estimated by the CV and SD were greater in the dapagliflozin group.,"['individuals with uncontrolled type 2 diabetes (T2D', 'individuals with uncontrolled T2D who were drug naïve or on steady-dose metformin monotherapy', 'Adults with Type 2 Diabetes Evaluated by Continuous Glucose Monitoring', '97 patients (age: 57.9±8.7\u2009years, male sex: 50.5%, baseline HbA1c: 63±9.8\u2009mmol/mol [7.9±0.9%]) were randomized, and 94 completed the 12-week protocol']","['gliclazide MR', 'dapagliflozin and gliclazide MR (modified release', 'dapagliflozin', 'Dapagliflozin', 'continuous glucose monitoring (CGM', 'Gliclazide']","['glucose time', 'Intention-to-treat (ITT', 'CGM and GV index calculations', 'GV and increased TIR', 'Glycemic Variability', 'glycemic variability (GV) and glycemic control', 'mean amplitude of glycemic excursions (MAGE', 'GV estimated by the CV and SD']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0205361', 'cui_str': 'Steady (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C4523945', 'cui_str': 'Continuous glucose monitoring'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C0017631', 'cui_str': 'Gliclazide'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C4523945', 'cui_str': 'Continuous glucose monitoring'}]","[{'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}]",97.0,0.0868109,The reductions in GV estimated by the CV and SD were greater in the dapagliflozin group.,"[{'ForeName': 'Andre G D', 'Initials': 'AGD', 'LastName': 'Vianna', 'Affiliation': 'Curitiba Diabetes Centre, Department of Endocrine Diseases, Hospital Nossa Senhora das Graças, Curitiba, Brazil.'}, {'ForeName': 'Claudio S', 'Initials': 'CS', 'LastName': 'Lacerda', 'Affiliation': 'Curitiba Diabetes Centre, Department of Endocrine Diseases, Hospital Nossa Senhora das Graças, Curitiba, Brazil.'}, {'ForeName': 'Luciana M', 'Initials': 'LM', 'LastName': 'Pechmann', 'Affiliation': 'Curitiba Diabetes Centre, Department of Endocrine Diseases, Hospital Nossa Senhora das Graças, Curitiba, Brazil.'}, {'ForeName': 'Michelle G', 'Initials': 'MG', 'LastName': 'Polesel', 'Affiliation': 'Curitiba Diabetes Centre, Department of Endocrine Diseases, Hospital Nossa Senhora das Graças, Curitiba, Brazil.'}, {'ForeName': 'Emerson C', 'Initials': 'EC', 'LastName': 'Marino', 'Affiliation': 'Curitiba Diabetes Centre, Department of Endocrine Diseases, Hospital Nossa Senhora das Graças, Curitiba, Brazil.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Scharf', 'Affiliation': 'Curitiba Diabetes Centre, Department of Endocrine Diseases, Hospital Nossa Senhora das Graças, Curitiba, Brazil.'}, {'ForeName': 'Josiane M', 'Initials': 'JM', 'LastName': 'Detsch', 'Affiliation': 'Curitiba Diabetes Centre, Department of Endocrine Diseases, Hospital Nossa Senhora das Graças, Curitiba, Brazil.'}, {'ForeName': 'Kleber', 'Initials': 'K', 'LastName': 'Marques', 'Affiliation': 'Curitiba Diabetes Centre, Department of Endocrine Diseases, Hospital Nossa Senhora das Graças, Curitiba, Brazil.'}, {'ForeName': 'Claudia P', 'Initials': 'CP', 'LastName': 'Sanches', 'Affiliation': 'Curitiba Diabetes Centre, Department of Endocrine Diseases, Hospital Nossa Senhora das Graças, Curitiba, Brazil.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13913']
3533,31841363,Long-Term Results of NRG Oncology RTOG 0617: Standard- Versus High-Dose Chemoradiotherapy With or Without Cetuximab for Unresectable Stage III Non-Small-Cell Lung Cancer.,"PURPOSE


RTOG 0617 compared standard-dose (SD; 60 Gy) versus high-dose (HD; 74 Gy) radiation with concurrent chemotherapy and determined the efficacy of cetuximab for stage III non-small-cell lung cancer (NSCLC).
METHODS


The study used a 2 × 2 factorial design with radiation dose as 1 factor and cetuximab as the other, with a primary end point of overall survival (OS).
RESULTS


Median follow-up was 5.1 years. There were 3 grade 5 adverse events (AEs) in the SD arm and 9 in the HD arm. Treatment-related grade ≥3 dysphagia and esophagitis occurred in 3.2% and 5.0% of patients in the SD arm  v  12.1% and 17.4% in the HD arm, respectively ( P  = .0005 and < .0001). There was no difference in pulmonary toxicity, with grade ≥3 AEs in 20.6% and 19.3%. Median OS was 28.7  v  20.3 months ( P  = .0072) in the SD and HD arms, respectively, 5-year OS and progression-free survival (PFS) rates were 32.1% and 23% and 18.3% and 13% ( P  = .055), respectively. Factors associated with improved OS on multivariable analysis were standard radiation dose, tumor location, institution accrual volume, esophagitis/dysphagia, planning target volume and heart V5. The use of cetuximab conferred no survival benefit at the expense of increased toxicity. The prior signal of benefit in patients with higher H scores was no longer apparent. The progression rate within 1 month of treatment completion in the SD arm was 4.6%. For comparison purposes, the resultant 2-year OS and PFS rates allowing for that dropout rate were 59.6% and 30.7%, respectively, in the SD arms.
CONCLUSION


A 60-Gy radiation dose with concurrent chemotherapy should remain the standard of care, with the OS rate being among the highest reported in the literature for stage III NSCLC. Cetuximab had no effect on OS. The 2-year OS rates in the control arm are similar to the PACIFIC trial.",2020,"Median OS was 28.7  v  20.3 months ( P  = .0072) in the SD and HD arms, respectively, 5-year OS and progression-free survival (PFS) rates were 32.1% and 23% and 18.3% and 13% ( P  = .055), respectively.",['0617'],"['Cetuximab', 'High-Dose Chemoradiotherapy With or Without Cetuximab', 'Standard', 'NRG Oncology RTOG', 'cetuximab']","['toxicity', 'grade ≥3 dysphagia and esophagitis', 'OS', 'pulmonary toxicity', '2-year OS and PFS rates', '5-year OS and progression-free survival (PFS) rates', '2-year OS rates', 'survival benefit', 'overall survival (OS', 'tumor location, institution accrual volume, esophagitis/dysphagia, planning target volume and heart V5', 'Median OS', 'progression rate']",[],"[{'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0014868', 'cui_str': 'Esophagitis'}, {'cui': 'C0919924', 'cui_str': 'Pulmonary toxicity'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0450429', 'cui_str': 'Location (attribute)'}, {'cui': 'C1272753', 'cui_str': 'Institution'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}]",,0.0980759,"Median OS was 28.7  v  20.3 months ( P  = .0072) in the SD and HD arms, respectively, 5-year OS and progression-free survival (PFS) rates were 32.1% and 23% and 18.3% and 13% ( P  = .055), respectively.","[{'ForeName': 'Jeffrey D', 'Initials': 'JD', 'LastName': 'Bradley', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Hu', 'Affiliation': 'NRG Oncology Statistics and Data Management Center, Pittsburgh, PA.'}, {'ForeName': 'Ritsuko R', 'Initials': 'RR', 'LastName': 'Komaki', 'Affiliation': 'Department of Thoracic/Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Masters', 'Affiliation': 'Medical Oncology Hematology Consultants, PA, Newark, DE.'}, {'ForeName': 'George R', 'Initials': 'GR', 'LastName': 'Blumenschein', 'Affiliation': 'Department of Thoracic/Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Schild', 'Affiliation': 'Mayo Clinic, Phoenix, AZ.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Bogart', 'Affiliation': 'State University of New York, Syracuse, NY.'}, {'ForeName': 'Kenneth M', 'Initials': 'KM', 'LastName': 'Forster', 'Affiliation': 'Geisinger Medical Center, Danville, PA.'}, {'ForeName': 'Anthony M', 'Initials': 'AM', 'LastName': 'Magliocco', 'Affiliation': 'Moffitt Cancer Center, Tampa, FL.'}, {'ForeName': 'Vivek S', 'Initials': 'VS', 'LastName': 'Kavadi', 'Affiliation': 'Texas Oncology-Sugar Land, Sugar Land, TX.'}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Narayan', 'Affiliation': 'Saint Joseph Mercy Hospital, Ann Arbor, MI.'}, {'ForeName': 'Puneeth', 'Initials': 'P', 'LastName': 'Iyengar', 'Affiliation': 'The University of Texas Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Clifford G', 'Initials': 'CG', 'LastName': 'Robinson', 'Affiliation': 'Washington University School of Medicine, St Louis, MO.'}, {'ForeName': 'Raymond B', 'Initials': 'RB', 'LastName': 'Wynn', 'Affiliation': 'UPMC Shadyside Hospital, Pittsburgh, PA.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Koprowski', 'Affiliation': 'Christiana Care Health Community Clinical Oncology Program, Newark, DE.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Olson', 'Affiliation': 'Baptist MD Anderson Cancer Center, Jacksonville, FL.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Meng', 'Affiliation': 'Ottawa Hospital and Cancer Center, Ottawa, Ontario, Canada.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Paulus', 'Affiliation': 'NRG Oncology Statistics and Data Management Center, Pittsburgh, PA.'}, {'ForeName': 'Walter J', 'Initials': 'WJ', 'LastName': 'Curran', 'Affiliation': 'Emory University, Atlanta, GA.'}, {'ForeName': 'Hak', 'Initials': 'H', 'LastName': 'Choy', 'Affiliation': 'The University of Texas Southwestern Medical Center, Dallas, TX.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.01162']
3534,31917765,"Double Low-Dose Dual-Energy Liver CT in Patients at High-Risk of HCC: A Prospective, Randomized, Single-Center Study.","OBJECTIVES


The aim of this study was to investigate the clinical feasibility of the simultaneous reduction of radiation and contrast doses using spectral computed tomography (CT) in patients at high-risk for hepatocellular carcinoma.
MATERIALS AND METHODS


Between May 2017 and March 2018, this prospective study recruited participants at risk of hepatocellular carcinoma with body mass indexes less than 30 and randomly assigned them to either the standard-dose group or the double low-dose group, which targeted 30% reductions in both radiation and contrast media (NCT03045445). Lesion conspicuity as a primary endpoint and lesion detection rates were then compared between hybrid iterative reconstruction (iDose) images of standard-dose group and low monoenergetic (50 keV) images of double low-dose group. Qualitative and quantitative image noise and contrast were also compared between the 2 groups. Participants and reviewers were blinded for scan protocols and reconstruction algorithms. Lesion conspicuity was analyzed using generalized estimating equation analysis. Lesion detection was evaluated using weighted jackknife alternative free-response receiver operating characteristic analysis.
RESULTS


Sixty-seven participants (male-to-female ratio, 59:8; mean age, 64 ± 9 years) were analyzed. Compared with the standard-dose group (n = 32), significantly lower CTDIvol (8.8 ± 1.7 mGy vs 6.1 ± 0.6 mGy) and contrast media (116.9 ± 15.7 mL vs 83.1 ± 9.9 mL) were utilized in the double low-dose group (n = 35; P < 0.001). Comparative analysis demonstrated that lesion conspicuity was significantly higher on 50 keV images of double low-dose group than on iDose images of standard dose on both arterial (2.62 [95% confidence interval (CI), 2.31-2.93] vs 2.02 [95% CI, 1.73-2.30], respectively, P = 0.004) and portal venous phases (2.39 [95% CI, 2.11-2.67] vs 1.88 [95% CI, 1.67-2.10], respectively, P = 0.005). No differences in lesion detection capability were observed between the 2 groups (figure of merit: 0.63 in standard-dose group; 0.65, double low-dose group; P = 0.52). Fifty kiloelectronvolt images of double low-dose group showed better subjective image noise and contrast than iDose image of standard-dose group on arterial and portal venous phases (P < 0.001 for all). Contrast-to-noise ratio of the aorta and portal vein was also higher in double low-dose group than in standard-dose group (P < 0.001 for all), whereas there was no significant difference of quantitative image noise between the 2 groups on arterial and portal phases (P = 0.4~0.5).
CONCLUSIONS


Low monoenergetic spectral CT images (50 keV) can provide better focal liver lesion conspicuity than hybrid iterative reconstruction image of standard-dose CT in nonobese patients while using lower radiation and contrast media doses.",2020,Fifty kiloelectronvolt images of double low-dose group showed better subjective image noise and contrast than iDose image of standard-dose group on arterial and portal venous phases (P < 0.001 for all).,"['Patients at High-Risk of HCC', 'patients at high-risk for hepatocellular carcinoma', 'Sixty-seven participants (male-to-female ratio, 59:8; mean age, 64 ± 9 years', 'participants at risk of hepatocellular carcinoma with body mass indexes less than 30']","['Double Low-Dose Dual-Energy Liver CT', 'spectral computed tomography (CT']","['Lesion detection', 'Contrast-to-noise ratio of the aorta and portal vein', 'Lesion conspicuity', 'lesion conspicuity', 'portal venous phases', 'arterial and portal venous phases', 'subjective image noise', 'quantitative image noise', 'lesion detection capability', 'lesion detection rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C2239176', 'cui_str': 'Liver Cell Carcinoma, Adult'}, {'cui': 'C4517852', 'cui_str': '67'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}]","[{'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0003483', 'cui_str': 'Aorta'}, {'cui': 'C0032718', 'cui_str': 'Portal Vein'}, {'cui': 'C0205054', 'cui_str': 'Portal (qualifier value)'}, {'cui': 'C0348013', 'cui_str': 'Venous (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}]",67.0,0.187382,Fifty kiloelectronvolt images of double low-dose group showed better subjective image noise and contrast than iDose image of standard-dose group on arterial and portal venous phases (P < 0.001 for all).,"[{'ForeName': 'Jeong Hee', 'Initials': 'JH', 'LastName': 'Yoon', 'Affiliation': 'From the Department of Radiology, Seoul National University Hospital.'}, {'ForeName': 'Won', 'Initials': 'W', 'LastName': 'Chang', 'Affiliation': 'Department of Radiology, Seoul National University Bundang Hospital.'}, {'ForeName': 'Eun Sun', 'Initials': 'ES', 'LastName': 'Lee', 'Affiliation': 'Department of Radiology, Chung-Ang University Hospital, Seoul.'}, {'ForeName': 'Sang Min', 'Initials': 'SM', 'LastName': 'Lee', 'Affiliation': 'Department of Radiology, Hallym University Sacred Heart Hospital, Anyang.'}, {'ForeName': 'Jeong Min', 'Initials': 'JM', 'LastName': 'Lee', 'Affiliation': 'From the Department of Radiology, Seoul National University Hospital.'}]",Investigative radiology,['10.1097/RLI.0000000000000643']
3535,32071329,A cluster-randomized trial of the effectiveness of a triple-faceted intervention promoting adherence to primary care physician visits by diabetes patients.,"We aimed to assess whether a triple-faceted intervention program administered in the primary care setting could decrease the risk of insufficient adherence to primary care physician (PCP) appointments among this patient population. We conducted a cluster-randomized controlled study to assess the effects of a 1-year intervention. The primary outcome was insufficient adherence to regular PCP attendance for diabetes treatment, defined as failure to visit a PCP within 2 months of an original appointment date. The intervention consisted of mailing patient reminders of their PCP appointments, providing patients with health education aimed at lifestyle modification and benchmarking PCP procedures. Eleven municipal level district medical associations employing 192 PCPs were divided into two subregions for assignment to intervention and control clusters, with 971 and 1,265 patients assigned to the intervention and control groups, respectively. Primary outcome data were available for 2,200 patients. The intervention reduced insufficient adherence to regular PCP appointments by 63% (hazard ratio, 0.37; 95% confidence interval [CI], 0.23-0.58). In conclusion, a triple-faceted intervention program consisting of health education, appointment reminders, and physician benchmarking may decrease the risk of incomplete adherence to regular PCP appointments by diabetes patients.",2020,"The intervention reduced insufficient adherence to regular PCP appointments by 63% (hazard ratio, 0.37; 95% confidence interval [CI], 0.23-0.58).","['primary care physician (PCP) appointments among this patient population', 'primary care physician visits by diabetes patients', 'Eleven municipal level district medical associations employing 192 PCPs']","['mailing patient reminders of their PCP appointments, providing patients with health education aimed at lifestyle modification and benchmarking PCP procedures', 'triple-faceted intervention', 'triple-faceted intervention program']","['insufficient adherence to regular PCP attendance for diabetes treatment, defined as failure to visit a PCP within 2 months of an original appointment date']","[{'cui': 'C0033131', 'cui_str': 'Primary Care Physicians'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0557351', 'cui_str': 'Employed (finding)'}, {'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C0031381', 'cui_str': '1-(1-Phenylcyclohexyl)piperidine'}]","[{'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0018701'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0031381', 'cui_str': '1-(1-Phenylcyclohexyl)piperidine'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0205174', 'cui_str': 'Triple (qualifier value)'}, {'cui': 'C0332225', 'cui_str': 'Faceted (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0231180', 'cui_str': 'Insufficient'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0031381', 'cui_str': '1-(1-Phenylcyclohexyl)piperidine'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205313', 'cui_str': 'Original (qualifier value)'}, {'cui': 'C0585085', 'cui_str': 'Appointment date (finding)'}]",192.0,0.0817496,"The intervention reduced insufficient adherence to regular PCP appointments by 63% (hazard ratio, 0.37; 95% confidence interval [CI], 0.23-0.58).","[{'ForeName': 'Mitsuhiko', 'Initials': 'M', 'LastName': 'Noda', 'Affiliation': 'Department of Diabetes, Metabolism and Endocrinology, Ichikawa Hospital, International University of Health and Welfare, 6-1-14 Kounodai, Ichikawa, Chiba, Japan. noda-m@iuhw.ac.jp.'}, {'ForeName': 'Yasuaki', 'Initials': 'Y', 'LastName': 'Hayashino', 'Affiliation': 'Department of Endocrinology, Tenri Hospital, 200 Mishimacho, Tenri, Nara, Japan.'}, {'ForeName': 'Katsuya', 'Initials': 'K', 'LastName': 'Yamazaki', 'Affiliation': 'First Department of Internal Medicine, Faculty of Medicine, Toyama University, 2630 Sugitani, Toyama, Toyama, Japan.'}, {'ForeName': 'Hikari', 'Initials': 'H', 'LastName': 'Suzuki', 'Affiliation': 'First Department of Internal Medicine, Faculty of Medicine, Toyama University, 2630 Sugitani, Toyama, Toyama, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Goto', 'Affiliation': 'Diabetes Research Center, National Center for Global Health and Medicine, 1-21-1 Toyama, Shinjuku-ku, Tokyo, Japan.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Kato', 'Affiliation': 'Toranomon Hospital Health Management Center and Diagnostic Imaging Center, 2-2-2 Toranomon, Minato-ku, Tokyo, Japan.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Izumi', 'Affiliation': 'Center for Clinical Sciences, National Center for Global Health and Medicine, 1-21-1 Toyama, Shinjuku-ku, Tokyo, Japan.'}, {'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Kobayashi', 'Affiliation': 'First Department of Internal Medicine, Faculty of Medicine, Toyama University, 2630 Sugitani, Toyama, Toyama, Japan.'}]",Scientific reports,['10.1038/s41598-020-59588-x']
3536,32114889,"Effect of Evolocumab on Non-High-Density Lipoprotein Cholesterol, Apolipoprotein B, and Lipoprotein(a): A Pooled Analysis of Phase 2 and Phase 3 Studies.","Background Dyslipidemia guidelines recommend non-high-density lipoprotein cholesterol (non-HDL-C) and apolipoprotein B (ApoB) as additional targets of therapy and consider lipoprotein(a) a significant cardiovascular risk marker. The current analysis evaluates the effects of evolocumab on these parameters in various patient populations over time. Methods and Results Data from 7690 patients, 4943 of whom received at least 1 dose of evolocumab, in 15 phase 2 and phase 3 studies with a duration ranging from 12 weeks to 5 years were pooled based on study length, patient population, and ezetimibe or placebo comparator groups. Patients could receive intensive statin therapy but not in the statin intolerance and monotherapy studies. The effects of evolocumab on percent change from baseline for non-HDL-C, ApoB, and lipoprotein(a) and achievement of treatment goals for non-HDL-C and ApoB were examined. Compared with placebo, evolocumab at both approved dosing regimens substantially reduced mean non-HDL-C (Q2W dose: -49% to -56%, monthly dose: -48% to -52%), mean ApoB (Q2W dose: -46% to -52%, monthly dose: -40% to -48%), and median lipoprotein(a) (Q2W dose: -22% to -38%, monthly dose: -20% to -33%) at 12 weeks. Effects on all 3 parameters persisted over 5 years. Lipid-lowering effects were consistent among the patient populations examined (hypercholesterolemia/mixed dyslipidemia, statin intolerance, heterozygous familial hypercholesterolemia, and type 2 diabetes mellitus). Conclusions In this pooled analysis, evolocumab substantially reduced non-HDL-C, ApoB, and lipoprotein(a) compared with placebo. The effect was consistent and maintained in various patient populations over 5 years.",2020,"In this pooled analysis, evolocumab substantially reduced non-HDL-C, ApoB, and lipoprotein(a) compared with placebo.","['7690 patients, 4943 of whom received at least 1 dose of evolocumab, in 15 phase 2 and phase 3 studies with a duration ranging from 12\xa0weeks to 5\xa0years were pooled based on study length, patient population, and', 'patient populations examined (hypercholesterolemia/mixed dyslipidemia, statin intolerance, heterozygous familial hypercholesterolemia, and type 2 diabetes mellitus']","['ezetimibe or placebo', 'Evolocumab', 'intensive statin therapy', 'placebo', 'evolocumab', 'placebo, evolocumab']","['mean ApoB ', 'Non-High-Density Lipoprotein Cholesterol, Apolipoprotein B, and Lipoprotein(a']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C3529352', 'cui_str': 'evolocumab'}, {'cui': 'C0439560', 'cui_str': 'Phase 2 (qualifier value)'}, {'cui': 'C0439561', 'cui_str': 'Phase 3 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0337051', 'cui_str': 'Pool (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0020443', 'cui_str': 'High Cholesterol Levels'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemias'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0231199', 'cui_str': 'Intolerance, function (observable entity)'}, {'cui': 'C0342882', 'cui_str': 'Familial hypercholesterolemia - heterozygous (disorder)'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}]","[{'cui': 'C1142985', 'cui_str': 'ezetimibe'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3529352', 'cui_str': 'evolocumab'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0003593', 'cui_str': 'ApoB'}, {'cui': 'C0729627', 'cui_str': 'Non-HDL cholesterol'}]",7690.0,0.116167,"In this pooled analysis, evolocumab substantially reduced non-HDL-C, ApoB, and lipoprotein(a) compared with placebo.","[{'ForeName': 'Peter P', 'Initials': 'PP', 'LastName': 'Toth', 'Affiliation': 'Preventive Cardiology CGH Medical Center Sterling IL.'}, {'ForeName': 'Steven R', 'Initials': 'SR', 'LastName': 'Jones', 'Affiliation': 'The Johns Hopkins Ciccarone Center for the Prevention of Heart Disease Baltimore MD.'}, {'ForeName': 'Maria Laura', 'Initials': 'ML', 'LastName': 'Monsalvo', 'Affiliation': 'Global Development Amgen Inc. Thousand Oaks CA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Elliott-Davey', 'Affiliation': 'Global Development Amgen Ltd. Cambridge United Kingdom.'}, {'ForeName': 'J Antonio G', 'Initials': 'JAG', 'LastName': 'López', 'Affiliation': 'Global Development Amgen Inc. Thousand Oaks CA.'}, {'ForeName': 'Maciej', 'Initials': 'M', 'LastName': 'Banach', 'Affiliation': ""Polish Mother's Memorial Hospital Research Institute (PMMHRI) Lodz Poland.""}]",Journal of the American Heart Association,['10.1161/JAHA.119.014129']
3537,32114892,Prognosis and Reclassification by YKL-40 in Stable Coronary Artery Disease.,"Background The inflammatory biomarker YKL-40 has previously been studied as a potential risk marker in cardiovascular disease. We aimed to assess the prognostic reclassification potential of serum YKL-40 in patients with stable coronary artery disease. Methods and Results The main study population was the placebo group of the CLARICOR (Effect of Clarithromycin on Mortality and Morbidity in Patients With Ischemic Heart Disease) trial. The primary outcome was a composite of acute myocardial infarction, unstable angina pectoris, cerebrovascular disease, and all-cause mortality. We used Cox proportional hazards regression models adjusted for C-reactive protein level and baseline cardiovascular risk factors. Improvement in prediction by adding serum YKL-40 to the risk factors was calculated using the Cox-Breslow method and c-statistic. A total of 2200 patients were randomized to placebo, with a follow-up duration of 10 years. YKL-40 was associated with an increased risk of the composite outcome (hazard ratio per unit increase in (YKL-40) 1.13, 95% CI 1.03-1.24,  P =0.013) and all-cause mortality (hazard ratio 1.32, 95% CI 1.17-1.49,  P <0.0001). Considering whether a composite-outcome event was more likely to have, or not have, occurred to date, we found 68.4% of such predictions to be correct when based on the standard predictors, and 68.5% when serum YKL-40 was added as a predictor. Equivalent results were obtained with c-statistics. Conclusions Higher serum YKL-40 was independently associated with an increased risk of adverse cardiovascular outcomes and mortality. Addition of YKL-40 did not improve risk prediction in patients with stable coronary artery disease. Clinical Trial Registration URL: https://www.clinicaltrials.gov/. Unique identifier: NCT00121550.",2020,"YKL-40 was associated with an increased risk of the composite outcome (hazard ratio per unit increase in (YKL-40) 1.13, 95% CI 1.03-1.24,  P =0.013) and all-cause mortality (hazard ratio 1.32, 95% CI 1.17-1.49,  P <0.0001).","['patients with stable coronary artery disease', 'Patients With Ischemic Heart Disease) trial', '2200 patients']","['serum YKL-40', 'YKL-40', 'placebo', 'Clarithromycin']","['risk prediction', 'Mortality and Morbidity', 'composite of acute myocardial infarction, unstable angina pectoris, cerebrovascular disease, and all-cause mortality', 'risk of adverse cardiovascular outcomes and mortality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0151744', 'cui_str': 'Ischemic Heart Disease'}, {'cui': 'C4517651', 'cui_str': 'Two thousand two hundred'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0055856', 'cui_str': 'Clarithromycin'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction (disorder)'}, {'cui': 'C0002965', 'cui_str': 'Angina at Rest'}, {'cui': 'C0007820', 'cui_str': 'Intracranial Vascular Disorders'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}]",2200.0,0.288654,"YKL-40 was associated with an increased risk of the composite outcome (hazard ratio per unit increase in (YKL-40) 1.13, 95% CI 1.03-1.24,  P =0.013) and all-cause mortality (hazard ratio 1.32, 95% CI 1.17-1.49,  P <0.0001).","[{'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Schroder', 'Affiliation': 'Department of Cardiology Bispebjerg Hospital University of Copenhagen Copenhagen Denmark.'}, {'ForeName': 'Janus Christian', 'Initials': 'JC', 'LastName': 'Jakobsen', 'Affiliation': 'Copenhagen Trial Unit Centre for Clinical Intervention Research Rigshospitalet, Copenhagen University Hospital Copenhagen Denmark.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Winkel', 'Affiliation': 'Copenhagen Trial Unit Centre for Clinical Intervention Research Rigshospitalet, Copenhagen University Hospital Copenhagen Denmark.'}, {'ForeName': 'Jørgen', 'Initials': 'J', 'LastName': 'Hilden', 'Affiliation': 'Section\xa0of Biostatistics Department of Public Health Research University of Copenhagen Copenhagen Denmark.'}, {'ForeName': 'Gorm Boje', 'Initials': 'GB', 'LastName': 'Jensen', 'Affiliation': 'Department of Cardiology Hvidovre Hospital Copenhagen University Hospital Copenhagen Denmark.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Sajadieh', 'Affiliation': 'Department of Cardiology Bispebjerg Hospital University of Copenhagen Copenhagen Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Larsson', 'Affiliation': 'Department of Medical Sciences Uppsala University Uppsala Sweden.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Ärnlöv', 'Affiliation': 'Department of Neurobiology, Care Sciences and Society/Division of Family Medicine Karolinska Institute Stockholm Sweden.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Harutyunyan', 'Affiliation': 'Department of Cardiology Rigshospitalet University of Copenhagen København Denmark.'}, {'ForeName': 'Julia S', 'Initials': 'JS', 'LastName': 'Johansen', 'Affiliation': 'Department of Medicine Herlev and Gentofte Hospital Copenhagen Denmark.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Kjøller', 'Affiliation': 'Copenhagen Trial Unit Centre for Clinical Intervention Research Rigshospitalet, Copenhagen University Hospital Copenhagen Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Gluud', 'Affiliation': 'Copenhagen Trial Unit Centre for Clinical Intervention Research Rigshospitalet, Copenhagen University Hospital Copenhagen Denmark.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Kastrup', 'Affiliation': 'Department of Cardiology Rigshospitalet University of Copenhagen København Denmark.'}]",Journal of the American Heart Association,['10.1161/JAHA.119.014634']
3538,31736357,Results of the FUEL Trial.,"BACKGROUND


The Fontan operation creates a total cavopulmonary connection, a circulation in which the importance of pulmonary vascular resistance is magnified. Over time, this circulation leads to deterioration of cardiovascular efficiency associated with a decline in exercise performance. Rigorous clinical trials aimed at improving physiology and guiding pharmacotherapy are lacking.
METHODS


The FUEL trial (Fontan Udenafil Exercise Longitudinal) was a phase III clinical trial conducted at 30 centers. Participants were randomly assigned udenafil, 87.5 mg twice daily, or placebo in a 1:1 ratio. The primary outcome was the between-group difference in change in oxygen consumption at peak exercise. Secondary outcomes included between-group differences in changes in submaximal exercise at the ventilatory anaerobic threshold, the myocardial performance index, the natural log of the reactive hyperemia index, and serum brain-type natriuretic peptide.
RESULTS


Between 2017 and 2019, 30 clinical sites in North America and the Republic of Korea randomly assigned 400 participants with Fontan physiology. The mean age at randomization was 15.5±2 years; 60% of participants were male, and 81% were white. All 400 participants were included in the primary analysis with imputation of the 26-week end point for 21 participants with missing data (11 randomly assigned to udenafil and 10 to placebo). Among randomly assigned participants, peak oxygen consumption increased by 44±245 mL/min (2.8%) in the udenafil group and declined by 3.7±228 mL/min (-0.2%) in the placebo group ( P =0.071). Analysis at ventilatory anaerobic threshold demonstrated improvements in the udenafil group versus the placebo group in oxygen consumption (+33±185 [3.2%] versus -9±193 [-0.9%] mL/min,  P =0.012), ventilatory equivalents of carbon dioxide (-0.8 versus -0.06,  P =0.014), and work rate (+3.8 versus +0.34 W,  P =0.021). There was no difference in change of myocardial performance index, the natural log of the reactive hyperemia index, or serum brain-type natriuretic peptide level.
CONCLUSIONS


In the FUEL trial, treatment with udenafil (87.5 mg twice daily) was not associated with an improvement in oxygen consumption at peak exercise but was associated with improvements in multiple measures of exercise performance at the ventilatory anaerobic threshold.
CLINICAL TRIAL REGISTRATION


URL: https://www.clinicaltrials.gov. Unique identifier: NCT02741115.",2020,"Among randomized participants, peak oxygen consumption increased by 44 ±245 mL/min (2.8%) in the udenafil group and declined by 3.7 ±228 mL/min (-0.2%) in the placebo group (p=0.071).","['All 400 participants were included in the primary analysis with imputation of the 26-week endpoint for 21 participants with missing data (11 randomized to udenafil and 10 to', 'Between 2017 and 2019, 30 clinical sites in North America and the Republic of Korea randomized 400 participants with Fontan physiology', '30 centers', 'The mean age at randomization was 15.5 ±2 years; 60% of participants were male and 81% were White']","['placebo', 'Fontan Udenafil Exercise Longitudinal (FUEL', 'udenafil']","['oxygen consumption', 'changes in sub-maximal exercise at the ventilatory anaerobic threshold (VAT), the myocardial performance index (MPI), the natural log of the reactive hyperemia index (lnRHI), and serum brain-type natriuretic peptide (BNP', 'change in oxygen consumption at peak exercise', 'ventilatory equivalents of carbon dioxide', 'change of MPI, lnRHI, or serum BNP level', 'work rate', 'peak oxygen consumption']","[{'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1742789', 'cui_str': '3-(1-Methyl-7-oxo-3-propyl-4,7-dihydro-1H-pyrazolo(4,3-d)pyrimidin-5-yl)-N-(2-(1-methyl-2-pyrrolidinyl)ethyl)-4-propoxybenzenesulfonamide'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0022773', 'cui_str': 'South Korea'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0043157', 'cui_str': 'Whites'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1742789', 'cui_str': '3-(1-Methyl-7-oxo-3-propyl-4,7-dihydro-1H-pyrazolo(4,3-d)pyrimidin-5-yl)-N-(2-(1-methyl-2-pyrrolidinyl)ethyl)-4-propoxybenzenesulfonamide'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal (qualifier value)'}, {'cui': 'C0556991', 'cui_str': 'Fuel (substance)'}]","[{'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0002749', 'cui_str': 'Anaerobic Threshold'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205296', 'cui_str': 'Natural (qualifier value)'}, {'cui': 'C0178824', 'cui_str': 'Reactive Hyperemia'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C1144709', 'cui_str': 'Natriuretic Peptides'}, {'cui': 'C1095989', 'cui_str': 'Brain natriuretic peptide measurement (procedure)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0043227', 'cui_str': 'Work'}]",400.0,0.492881,"Among randomized participants, peak oxygen consumption increased by 44 ±245 mL/min (2.8%) in the udenafil group and declined by 3.7 ±228 mL/min (-0.2%) in the placebo group (p=0.071).","[{'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Goldberg', 'Affiliation': ""Division of Cardiology, The Children's Hospital of Philadelphia, Perelman School of Medicine, PA (D.J.G., S.W., M.G.M., S.M.P.).""}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Zak', 'Affiliation': 'New England Research Institutes, Watertown, MA (V.Z.).'}, {'ForeName': 'Bryan H', 'Initials': 'BH', 'LastName': 'Goldstein', 'Affiliation': ""Division of Cardiology, Cincinnati Children's Hospital Medical Center, OH (B.H.G., M.S.H., K.A.R., E.M.U.).""}, {'ForeName': 'Kurt R', 'Initials': 'KR', 'LastName': 'Schumacher', 'Affiliation': ""Division of Cardiology, C.S. Mott Children's Hospital, Ann Arbor, MI (K.R.S., M.W.R.).""}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Rhodes', 'Affiliation': ""Department of Cardiology, Children's Hospital Boston, MA (J.R.).""}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Penny', 'Affiliation': ""Division of Cardiology, Texas Children's Hospital, Baylor College of Medicine, Houston, TX (D.J.P.).""}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Petit', 'Affiliation': ""Emory University School of Medicine, Children's Healthcare of Atlanta, GA (C.J.P.).""}, {'ForeName': 'Salil', 'Initials': 'S', 'LastName': 'Ginde', 'Affiliation': ""Division of Cardiology, Medical College of Wisconsin, Children's Hospital of Wisconsin, Milwaukee (S.G., P.C.F.).""}, {'ForeName': 'Shaji C', 'Initials': 'SC', 'LastName': 'Menon', 'Affiliation': 'Division of Pediatric Cardiology, University of Utah, Salt Lake City (S.C.M.).'}, {'ForeName': 'Seong-Ho', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'Department of Pediatrics, Sejong General Hospital, Bucheon-Si, South Korea (S.-H.K.).'}, {'ForeName': 'Gi Beom', 'Initials': 'GB', 'LastName': 'Kim', 'Affiliation': ""Seoul National University School of Medicine, Seoul National University Children's Hospital, South Korea (G.B.K.).""}, {'ForeName': 'Todd T', 'Initials': 'TT', 'LastName': 'Nowlen', 'Affiliation': ""Heart Center, Phoenix Children's Hospital, AZ (T.T.N.).""}, {'ForeName': 'Michael V', 'Initials': 'MV', 'LastName': 'DiMaria', 'Affiliation': ""Department of Pediatrics, Children's Hospital Colorado, University of Colorado School of Medicine, Aurora (M.V.D.).""}, {'ForeName': 'Benjamin P', 'Initials': 'BP', 'LastName': 'Frischhertz', 'Affiliation': 'Division of Cardiology, Vanderbilt University School of Medicine, Nashville, TN (B.P.F.).'}, {'ForeName': 'Jonathan B', 'Initials': 'JB', 'LastName': 'Wagner', 'Affiliation': ""Divisions of Cardiology and Clinical Pharmacology, Children's Mercy Kansas City, MO (J.B.W.).""}, {'ForeName': 'Kimberly E', 'Initials': 'KE', 'LastName': 'McHugh', 'Affiliation': 'Division of Pediatric Cardiology, Medical University of South Carolina, Charleston (K.E.M.).'}, {'ForeName': 'Brian W', 'Initials': 'BW', 'LastName': 'McCrindle', 'Affiliation': 'Division of Cardiology, The Hospital for Sick Children, University of Toronto, Ontario (B.W.M.).'}, {'ForeName': 'Amanda J', 'Initials': 'AJ', 'LastName': 'Shillingford', 'Affiliation': 'Nemours Cardiac Center, Nemours/Alfred I. DuPont Hospital for Children, Wilmington, DE (A.J.S.).'}, {'ForeName': 'Arash A', 'Initials': 'AA', 'LastName': 'Sabati', 'Affiliation': ""Los Angeles Children's Hospital, Division of Cardiology, CA (A.A.S.).""}, {'ForeName': 'Anji T', 'Initials': 'AT', 'LastName': 'Yetman', 'Affiliation': ""Children's Hospital and Medical Center, University of Nebraska, Omaha (A.T.Y.).""}, {'ForeName': 'Anitha S', 'Initials': 'AS', 'LastName': 'John', 'Affiliation': ""Division of Cardiology, Children's National Health System, Washington, DC (A.S.J.).""}, {'ForeName': 'Marc E', 'Initials': 'ME', 'LastName': 'Richmond', 'Affiliation': ""Division of Pediatric Cardiology, Morgan Stanley Children's Hospital, Columbia University Medical Center, New York, NY (M.E.R.).""}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Files', 'Affiliation': ""Division of Cardiology, Seattle Children's Hospital, WA (M.D.F.).""}, {'ForeName': 'R Mark', 'Initials': 'RM', 'LastName': 'Payne', 'Affiliation': 'Division of Cardiology, Riley Hospital for Children, Indianapolis, IN (R.M.P.).'}, {'ForeName': 'Andrew S', 'Initials': 'AS', 'LastName': 'Mackie', 'Affiliation': ""Division of Cardiology, Stollery Children's Hospital, Edmonton, Alberta, Canada (A.S.M.).""}, {'ForeName': 'Christopher K', 'Initials': 'CK', 'LastName': 'Davis', 'Affiliation': ""Division of Cardiology, Rady Children's Hospital, San Diego, CA (C.K.D.).""}, {'ForeName': 'Shabana', 'Initials': 'S', 'LastName': 'Shahanavaz', 'Affiliation': ""Division of Cardiology, St Louis Children's Hospital, MO (S.S.).""}, {'ForeName': 'Kevin D', 'Initials': 'KD', 'LastName': 'Hill', 'Affiliation': ""Duke Children's Pediatric and Congenital Heart Center, Durham, NC (K.D.H.).""}, {'ForeName': 'Ruchira', 'Initials': 'R', 'LastName': 'Garg', 'Affiliation': 'Division of Cardiology, Cedars-Sinai Medical Center, Los Angeles, CA (R.G.).'}, {'ForeName': 'Jeffrey P', 'Initials': 'JP', 'LastName': 'Jacobs', 'Affiliation': ""Johns Hopkins All Children's Hospital, Department of Surgery, St Petersburg, FL (J.P.J.).""}, {'ForeName': 'Michelle S', 'Initials': 'MS', 'LastName': 'Hamstra', 'Affiliation': ""Division of Cardiology, Cincinnati Children's Hospital Medical Center, OH (B.H.G., M.S.H., K.A.R., E.M.U.).""}, {'ForeName': 'Stacy', 'Initials': 'S', 'LastName': 'Woyciechowski', 'Affiliation': ""Division of Cardiology, The Children's Hospital of Philadelphia, Perelman School of Medicine, PA (D.J.G., S.W., M.G.M., S.M.P.).""}, {'ForeName': 'Kathleen A', 'Initials': 'KA', 'LastName': 'Rathge', 'Affiliation': ""Division of Cardiology, Cincinnati Children's Hospital Medical Center, OH (B.H.G., M.S.H., K.A.R., E.M.U.).""}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'McBride', 'Affiliation': ""Division of Cardiology, The Children's Hospital of Philadelphia, Perelman School of Medicine, PA (D.J.G., S.W., M.G.M., S.M.P.).""}, {'ForeName': 'Peter C', 'Initials': 'PC', 'LastName': 'Frommelt', 'Affiliation': ""Division of Cardiology, Medical College of Wisconsin, Children's Hospital of Wisconsin, Milwaukee (S.G., P.C.F.).""}, {'ForeName': 'Mark W', 'Initials': 'MW', 'LastName': 'Russell', 'Affiliation': ""Division of Cardiology, C.S. Mott Children's Hospital, Ann Arbor, MI (K.R.S., M.W.R.).""}, {'ForeName': 'Elaine M', 'Initials': 'EM', 'LastName': 'Urbina', 'Affiliation': ""Division of Cardiology, Cincinnati Children's Hospital Medical Center, OH (B.H.G., M.S.H., K.A.R., E.M.U.).""}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Yeager', 'Affiliation': 'Consultant to Mezzion Pharma Co Ltd, Mezzion Pharma Co Ltd, Seoul, South Korea (J.L.Y.).'}, {'ForeName': 'Victoria L', 'Initials': 'VL', 'LastName': 'Pemberton', 'Affiliation': 'Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (V.L.P., M.P.S., G.D.P.).'}, {'ForeName': 'Mario P', 'Initials': 'MP', 'LastName': 'Stylianou', 'Affiliation': 'Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (V.L.P., M.P.S., G.D.P.).'}, {'ForeName': 'Gail D', 'Initials': 'GD', 'LastName': 'Pearson', 'Affiliation': 'Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (V.L.P., M.P.S., G.D.P.).'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Paridon', 'Affiliation': ""Division of Cardiology, The Children's Hospital of Philadelphia, Perelman School of Medicine, PA (D.J.G., S.W., M.G.M., S.M.P.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation,['10.1161/CIRCULATIONAHA.119.044352']
3539,32122216,"Platelet Inhibition, Endothelial Function, and Clinical Outcome in Patients Presenting With ST-Segment-Elevation Myocardial Infarction Randomized to Ticagrelor Versus Prasugrel Maintenance Therapy: Long-Term Follow-Up of the REDUCE-MVI Trial.","Background Off-target properties of ticagrelor might reduce microvascular injury and improve clinical outcome in patients with ST-segment-elevation myocardial infarction. The REDUCE-MVI (Evaluation of Microvascular Injury in Revascularized Patients with ST-Segment-Elevation Myocardial Infarction Treated With Ticagrelor Versus Prasugrel) trial reported no benefit of ticagrelor regarding microvascular function at 1 month. We now present the follow-up data up to 1.5 years. Methods and Results We randomized 110 patients with ST-segment-elevation myocardial infarction to either ticagrelor 90 mg twice daily or prasugrel 10 mg once a day. Platelet inhibition and peripheral endothelial function measurements including calculation of the reactive hyperemia index and clinical follow-up were obtained up to 1.5 years. Major adverse clinical events and bleedings were scored. An intention to treat and a per-protocol analysis were performed. There were no between-group differences in platelet inhibition and endothelial function. At 1 year the reactive hyperemia index in the ticagrelor group was 0.66±0.26 versus 0.61±0.28 in the prasugrel group ( P =0.31). Platelet inhibition was lower at 1 month versus 1 year in the total study population (61% [42%-81%] versus 83% [61%-95%];  P <0.001), and per-protocol platelet inhibition was higher in patients randomized to ticagrelor versus prasugrel at 1 year (91% [83%-97%] versus 82% [65%-92%];  P =0.002). There was an improvement in intention to treat endothelial function in patients randomized to ticagrelor ( P =0.03) but not in patients randomized to prasugrel ( P =0.88). Major adverse clinical events (10% versus 14%;  P =0.54) and bleedings (47% versus 63%;  P =0.10) were similar in the intention-to-treat analysis in both groups. Conclusions Platelet inhibition at 1 year was higher in the ticagrelor group, without an accompanying increase in bleedings. Endothelial function improved over time in ticagrelor patients, while it did not change in the prasugrel group. Clinical Trial Registration URL: https://www.clinicaltrials.gov/. Unique Identifier: NCT02422888.",2020,At 1 year the reactive hyperemia index in the ticagrelor group was 0.66±0.26 versus 0.61±0.28 in the prasugrel group ( P =0.31).,"['Revascularized Patients with ST-Segment-Elevation Myocardial Infarction Treated With', 'Patients Presenting With', 'patients with ST-segment-elevation myocardial infarction', '110 patients with ST-segment-elevation myocardial infarction to either']","['ticagrelor 90\xa0mg twice daily or prasugrel 10\xa0mg once a day', 'Ticagrelor Versus Prasugrel Maintenance Therapy', 'ticagrelor', 'Ticagrelor Versus Prasugrel']","['intention to treat endothelial function', 'Major adverse clinical events', 'Conclusions Platelet inhibition', 'Endothelial function', 'Platelet inhibition', 'per-protocol platelet inhibition', 'bleedings', 'Platelet Inhibition, Endothelial Function, and Clinical Outcome', 'platelet inhibition and endothelial function', 'reactive hyperemia index']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1536220', 'cui_str': 'ST Elevated Myocardial Infarction'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}]","[{'cui': 'C3163568', 'cui_str': 'Ticagrelor 90 MG'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C2710121', 'cui_str': 'prasugrel 10 MG [Effient]'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C1620287', 'cui_str': 'prasugrel'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}]","[{'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0178824', 'cui_str': 'Reactive Hyperemia'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",110.0,0.145099,At 1 year the reactive hyperemia index in the ticagrelor group was 0.66±0.26 versus 0.61±0.28 in the prasugrel group ( P =0.31).,"[{'ForeName': 'Nina W', 'Initials': 'NW', 'LastName': 'van der Hoeven', 'Affiliation': 'Department of Cardiology Amsterdam UMC Vrije Universiteit Amsterdam Amsterdam Cardiovascular Sciences Amsterdam the Netherlands.'}, {'ForeName': 'Gladys N', 'Initials': 'GN', 'LastName': 'Janssens', 'Affiliation': 'Department of Cardiology Amsterdam UMC Vrije Universiteit Amsterdam Amsterdam Cardiovascular Sciences Amsterdam the Netherlands.'}, {'ForeName': 'Henk', 'Initials': 'H', 'LastName': 'Everaars', 'Affiliation': 'Department of Cardiology Amsterdam UMC Vrije Universiteit Amsterdam Amsterdam Cardiovascular Sciences Amsterdam the Netherlands.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Nap', 'Affiliation': 'Department of Cardiology Amsterdam UMC Vrije Universiteit Amsterdam Amsterdam Cardiovascular Sciences Amsterdam the Netherlands.'}, {'ForeName': 'Jorrit S', 'Initials': 'JS', 'LastName': 'Lemkes', 'Affiliation': 'Department of Cardiology Amsterdam UMC Vrije Universiteit Amsterdam Amsterdam Cardiovascular Sciences Amsterdam the Netherlands.'}, {'ForeName': 'Guus A', 'Initials': 'GA', 'LastName': 'de Waard', 'Affiliation': 'Department of Cardiology Amsterdam UMC Vrije Universiteit Amsterdam Amsterdam Cardiovascular Sciences Amsterdam the Netherlands.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'van de Ven', 'Affiliation': 'Department of Epidemiology and Biostatistics Amsterdam UMC Vrije Universiteit Amsterdam Amsterdam Cardiovascular Sciences Amsterdam the Netherlands.'}, {'ForeName': 'Albert C', 'Initials': 'AC', 'LastName': 'van Rossum', 'Affiliation': 'Department of Cardiology Amsterdam UMC Vrije Universiteit Amsterdam Amsterdam Cardiovascular Sciences Amsterdam the Netherlands.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Escaned', 'Affiliation': 'Hospital Clínico San Carlos IDISSC and Universidad Complutense de Madrid Madrid Spain.'}, {'ForeName': 'Hernan', 'Initials': 'H', 'LastName': 'Mejia-Renteria', 'Affiliation': 'Hospital Clínico San Carlos IDISSC and Universidad Complutense de Madrid Madrid Spain.'}, {'ForeName': 'Tim J F', 'Initials': 'TJF', 'LastName': 'Ten Cate', 'Affiliation': 'Department of Cardiology Radboud University Medical Center Nijmegen the Netherlands.'}, {'ForeName': 'Jan J', 'Initials': 'JJ', 'LastName': 'Piek', 'Affiliation': 'Department of Cardiology Amsterdam UMC Academic Medical Center Amsterdam Cardiovascular Sciences Amsterdam the Netherlands.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'von Birgelen', 'Affiliation': 'Department of Cardiology Medisch Spectrum Twente Enschede the Netherlands.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Valgimigli', 'Affiliation': 'Department of Cardiology Bern University Hospital Bern Switzerland.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Diletti', 'Affiliation': 'Department of Cardiology Erasmus MC Rotterdam the Netherlands.'}, {'ForeName': 'Niels P', 'Initials': 'NP', 'LastName': 'Riksen', 'Affiliation': 'Department of Cardiology Amsterdam UMC Vrije Universiteit Amsterdam Amsterdam Cardiovascular Sciences Amsterdam the Netherlands.'}, {'ForeName': 'Nicolas M', 'Initials': 'NM', 'LastName': 'Van Mieghem', 'Affiliation': 'Department of Cardiology Erasmus MC Rotterdam the Netherlands.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Nijveldt', 'Affiliation': 'Department of Cardiology Amsterdam UMC Vrije Universiteit Amsterdam Amsterdam Cardiovascular Sciences Amsterdam the Netherlands.'}, {'ForeName': 'Maarten A H', 'Initials': 'MAH', 'LastName': 'van Leeuwen', 'Affiliation': 'Department of Cardiology Amsterdam UMC Vrije Universiteit Amsterdam Amsterdam Cardiovascular Sciences Amsterdam the Netherlands.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'van Royen', 'Affiliation': 'Department of Cardiology Amsterdam UMC Vrije Universiteit Amsterdam Amsterdam Cardiovascular Sciences Amsterdam the Netherlands.'}]",Journal of the American Heart Association,['10.1161/JAHA.119.014411']
3540,31387766,A randomized controlled trial of public messaging to promote safe firearm storage among U.S. military veterans.,"BACKGROUND


The objectives of this study were to determine whether short-term exposure to firearm safety messaging significantly improved (1) firearm storage practices, and (2) attitudes of safe firearm storage behaviors among U.S. veterans, a group at elevated risk for firearm suicide.
DESIGN


A three-arm, parallel-group RCT was conducted online in the U.S. nationwide from December 2015 to January 2016.
SETTING


A national random sample of U.S. veterans (N = 358) was recruited from the GfK KnowledgePanel, a probability-based internet panel representative of U.S. adults. All study activities were administered online over a three-week study period.
INTERVENTION


Participants were randomized and exposed three times (once per week) to either (a) firearm safety message only (n = 115); (b) firearm safety and mental health promotion messages (n = 133); or (c) active control group exposed to mental health promotion message only (n = 110). Each message was less than two minutes long.
MEASURES


Assessments were completed at baseline (pre-randomization) and at end-of-trial. Changes in awareness of risk for injuries, attitudes/beliefs related to safe storage practices, behavioral intentions, and storage practices were measured using self-reported surveys. Linear mixed effect models with weighted generalized estimating equations were used to test for exposure effects. Analyses were conducted February 2018.
RESULTS


Analyses restricted to those with baseline firearm access (n = 195) identified no significant changes for intentions or safe storage practices across exposure groups. At baseline, participants' attitudes and beliefs were generally supportive of safe firearm storage. The Firearm Safety message yielded small increases in agreement with the concept that secure storage is ""important during emotional or stressful times"" (0.36; 95% CI = 0.08, 0.64). Other significant changes in awareness and beliefs were found, but across all study conditions.
CONCLUSION


Results reinforce the critical need for considerable research and testing prior to the widespread implementation of public messages to increase the likelihood for desired exposure effects.",2019,"Changes in awareness of risk for injuries, attitudes/beliefs related to safe storage practices, behavioral intentions, and storage practices were measured using self-reported surveys.","['U.S. military veterans', 'U.S. veterans, a group at elevated risk for firearm suicide', 'A national random sample of U.S. veterans (N\u202f=\u202f358) was recruited from the GfK KnowledgePanel, a probability-based internet panel representative of U.S. adults']","['public messaging', 'firearm safety message only (n\u202f=\u202f115); (b) firearm safety and mental health promotion messages (n\u202f=\u202f133); or (c) active control group exposed to mental health promotion message']","['awareness and beliefs', 'intentions or safe storage practices', 'awareness of risk for injuries, attitudes/beliefs related to safe storage practices, behavioral intentions, and storage practices']","[{'cui': 'C0026126', 'cui_str': 'Armed Forces Personnel'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0016139', 'cui_str': 'Firearms'}, {'cui': 'C0852733', 'cui_str': 'Suicide (accomplished)'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0016139', 'cui_str': 'Firearms'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4517540', 'cui_str': '115 (qualifier value)'}, {'cui': 'C0184645', 'cui_str': 'Mental health promotion'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1698986', 'cui_str': 'Storage (procedure)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}]",,0.0646168,"Changes in awareness of risk for injuries, attitudes/beliefs related to safe storage practices, behavioral intentions, and storage practices were measured using self-reported surveys.","[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Karras', 'Affiliation': 'Center of Excellence for Suicide Prevention, Department of Veterans Affairs, Canandaigua VA, Medical Center, 400 Fort Hill Avenue, Canandaigua, NY 14424, USA; Department of Psychiatry, University of Rochester, Rochester, NY, USA; Injury Control Research Center, West Virginia University, Morgantown, WV, USA. Electronic address: Elizabeth.Karras@va.gov.'}, {'ForeName': 'Cara M', 'Initials': 'CM', 'LastName': 'Stokes', 'Affiliation': 'Center of Excellence for Suicide Prevention, Department of Veterans Affairs, Canandaigua VA, Medical Center, 400 Fort Hill Avenue, Canandaigua, NY 14424, USA; Injury Control Research Center, West Virginia University, Morgantown, WV, USA; Department of Epidemiology, School of Public Health, West Virginia University, Morgantown, WV, USA.'}, {'ForeName': 'Sara C', 'Initials': 'SC', 'LastName': 'Warfield', 'Affiliation': 'Center of Excellence for Suicide Prevention, Department of Veterans Affairs, Canandaigua VA, Medical Center, 400 Fort Hill Avenue, Canandaigua, NY 14424, USA; Injury Control Research Center, West Virginia University, Morgantown, WV, USA; Department of Epidemiology, School of Public Health, West Virginia University, Morgantown, WV, USA.'}, {'ForeName': 'Shannon K', 'Initials': 'SK', 'LastName': 'Barth', 'Affiliation': 'Center of Excellence for Suicide Prevention, Department of Veterans Affairs, Canandaigua VA, Medical Center, 400 Fort Hill Avenue, Canandaigua, NY 14424, USA; Injury Control Research Center, West Virginia University, Morgantown, WV, USA; Department of Epidemiology, School of Public Health, West Virginia University, Morgantown, WV, USA.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Bossarte', 'Affiliation': 'Center of Excellence for Suicide Prevention, Department of Veterans Affairs, Canandaigua VA, Medical Center, 400 Fort Hill Avenue, Canandaigua, NY 14424, USA; Injury Control Research Center, West Virginia University, Morgantown, WV, USA; Department of Epidemiology, School of Public Health, West Virginia University, Morgantown, WV, USA; Department of Behavioral Medicine and Psychiatry, School of Medicine, West Virginia University, Morgantown, WV, USA.'}]",Social science & medicine (1982),['10.1016/j.socscimed.2019.03.001']
3541,31628428,Long-term efficacy and safety of first-line ibrutinib treatment for patients with CLL/SLL: 5 years of follow-up from the phase 3 RESONATE-2 study.,"RESONATE-2 is a phase 3 study of first-line ibrutinib versus chlorambucil in chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). Patients aged ≥65 years (n = 269) were randomized 1:1 to once-daily ibrutinib 420 mg continuously or chlorambucil 0.5-0.8 mg/kg for ≤12 cycles. With a median (range) follow-up of 60 months (0.1-66), progression-free survival (PFS) and overall survival (OS) benefits for ibrutinib versus chlorambucil were sustained (PFS estimates at 5 years: 70% vs 12%; HR [95% CI]: 0.146 [0.098-0.218]; OS estimates at 5 years: 83% vs 68%; HR [95% CI]: 0.450 [0.266-0.761]). Ibrutinib benefit was also consistent in patients with high prognostic risk (TP53 mutation, 11q deletion, and/or unmutated IGHV) (PFS: HR [95% CI]: 0.083 [0.047-0.145]; OS: HR [95% CI]: 0.366 [0.181-0.736]). Investigator-assessed overall response rate was 92% with ibrutinib (complete response, 30%; 11% at primary analysis). Common grade ≥3 adverse events (AEs) included neutropenia (13%), pneumonia (12%), hypertension (8%), anemia (7%), and hyponatremia (6%); occurrence of most events as well as discontinuations due to AEs decreased over time. Fifty-eight percent of patients continue to receive ibrutinib. Single-agent ibrutinib demonstrated sustained PFS and OS benefit versus chlorambucil and increased depth of response over time.",2020,Single-agent ibrutinib demonstrated sustained PFS and OS benefit versus chlorambucil and increased depth of response over time.,"['patients with CLL/SLL', 'chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL', 'Patients aged ≥65 years (n\u2009=\u2009269']","['daily ibrutinib 420\u2009mg continuously or chlorambucil 0.5-0.8\u2009mg/kg for ≤12 cycles', 'first-line ibrutinib treatment', 'chlorambucil']","['hyponatremia', 'Investigator-assessed overall response rate', 'progression-free survival (PFS) and overall survival (OS) benefits', 'anemia', 'pneumonia', 'neutropenia', 'hypertension']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023434', 'cui_str': 'Lymphoma, Small Lymphocytic'}, {'cui': 'C0024303', 'cui_str': 'Lymphocytic lymphoma'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C4555385', 'cui_str': 'Ibrutinib 420 MG'}, {'cui': 'C0008163', 'cui_str': 'Chlorambucil'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C3501358', 'cui_str': 'Ibrutinib'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0020625', 'cui_str': 'Hyponatremia'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}]",,0.152562,Single-agent ibrutinib demonstrated sustained PFS and OS benefit versus chlorambucil and increased depth of response over time.,"[{'ForeName': 'Jan A', 'Initials': 'JA', 'LastName': 'Burger', 'Affiliation': 'Department of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA. jaburger@mdanderson.org.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Barr', 'Affiliation': 'Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Tadeusz', 'Initials': 'T', 'LastName': 'Robak', 'Affiliation': 'Medical University of Lodz, Copernicus Memorial Hospital, Lodz, Poland.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Owen', 'Affiliation': 'Tom Baker Cancer Centre, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Ghia', 'Affiliation': 'Università Vita-Salute San Raffaele and IRCCS Ospedale San Raffaele, Milan, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Tedeschi', 'Affiliation': 'ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy.'}, {'ForeName': 'Osnat', 'Initials': 'O', 'LastName': 'Bairey', 'Affiliation': 'Rabin Medical Center, Petah Tikva, Israel and Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hillmen', 'Affiliation': 'The Leeds Teaching Hospitals, St. James Institute of Oncology, University of Leeds, Leeds, UK.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Coutre', 'Affiliation': 'Stanford Cancer Center, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Devereux', 'Affiliation': 'Kings College Hospital, NHS Foundation Trust, London, UK.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Grosicki', 'Affiliation': 'Department of Hematology and Cancer Prevention, Silesiam Medical University, Katowice, Poland.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'McCarthy', 'Affiliation': 'Royal Bournemouth General Hospital, Bournemouth, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Simpson', 'Affiliation': 'North Shore Hospital, Auckland, New Zealand.'}, {'ForeName': 'Fritz', 'Initials': 'F', 'LastName': 'Offner', 'Affiliation': 'Universitair Ziekenhuis Gent, Gent, Belgium.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Moreno', 'Affiliation': 'Hospital de la Santa Creu i Sant Pau, Autonomous University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Dai', 'Affiliation': 'Pharmacyclics LLC, an AbbVie Company, Sunnyvale, CA, USA.'}, {'ForeName': 'Indu', 'Initials': 'I', 'LastName': 'Lal', 'Affiliation': 'Pharmacyclics LLC, an AbbVie Company, Sunnyvale, CA, USA.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Dean', 'Affiliation': 'Pharmacyclics LLC, an AbbVie Company, Sunnyvale, CA, USA.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Kipps', 'Affiliation': 'UCSD Moores Cancer Center, San Diego, CA, USA.'}]",Leukemia,['10.1038/s41375-019-0602-x']
3542,32114709,Intraocular pharmacokinetics of anti-vascular endothelial growth factor agents by intraoperative subretinal versus intravitreal injection in silicone oil-filled eyes of proliferative diabetic retinopathy: a randomized controlled pilot study.,"PURPOSE


Intraoperative subretinal anti-vascular endothelial growth factor (VEGF) injections have been used clinically in some case, but the pharmacokinetic characteristics have not yet been determined. In this pilot study, we investigate the pharmacokinetic parameters of anti-VEGF agents by intraoperative subretinal or intravitreal injection in silicone oil (SiO)-filled eyes of patients with proliferative diabetic retinopathy (PDR).
METHODS


Randomized controlled trial including 13 patients (16 eyes) with PDR underwent pars plana vitrectomy (PPV) with SiO tamponade and randomly received a subretinal (8 eyes) or intravitreal (8 eyes) conbercept injection (0.5 mg/0.05 ml) intraoperatively. Aqueous humour (AH) was obtained on the 1st, 3rd, 7th, 10th, 14th, 21st and 28th day after the injection. Drug concentrations in the AH were determined by enzyme-linked immunosorbent assay (ELISA). The last best-corrected visual acuity (BCVA) was examined 6 months postoperatively.
RESULTS


The clearance rate of anti-VEGF agents by subretinal injection was reduced in vitrectomized eyes with SiO tamponade (p < 0.05). With the same drug dose, subretinal injection (5.49 ± 6.11 μg/ml) resulted in higher drug concentrations in the AH when compared with intravitreal injection (0.42 ± 0.46 μg/ml, p = 0.001) 4 weeks after the treatment. The mean residence time last (MRT 0-t  ) by subretinal injection (11.57 ± 0.83 days) was significantly longer than the mean MRT 0-t  by intravitreal injection (7.10 ± 1.00 days, p < 0.001). A self-paired analysis showed that subretinal injection led to the BCVA improvement by +28.59 letters 6 months postoperatively (p = 0.028) while the BCVA did not improve significantly by intravitreal injection (p = 0.715).
CONCLUSIONS


The drug maintenance phase was prolonged by intraoperative subretinal injection in SiO-filled eyes of PDR. The results suggest that subretinal injection might be a valuable treatment option for the management of PDR.",2020,The clearance rate of anti-VEGF agents by subretinal injection was reduced in vitrectomized eyes with SiO tamponade (p < 0.05).,"['13 patients (16 eyes) with', 'patients with proliferative diabetic retinopathy (PDR', 'silicone oil-filled eyes of proliferative diabetic retinopathy']","['anti-vascular endothelial growth factor agents by intraoperative subretinal versus intravitreal injection', 'PDR underwent pars plana vitrectomy (PPV) with SiO tamponade and randomly received a subretinal (8 eyes) or intravitreal (8 eyes) conbercept injection', 'anti-VEGF agents by intraoperative subretinal or intravitreal injection in silicone oil (SiO)-filled eyes', 'Intraoperative subretinal anti-vascular endothelial growth factor (VEGF) injections']","['mean residence time last (MRT 0-t  ) by subretinal injection', 'higher drug concentrations', 'clearance rate of anti-VEGF agents by subretinal injection', 'BCVA', 'corrected visual acuity (BCVA', 'BCVA improvement']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0154830', 'cui_str': 'PDR - proliferative diabetic retinopathy'}, {'cui': 'C0037111', 'cui_str': 'Silicone Oils'}]","[{'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C1554888', 'cui_str': 'Intravitreal Injections'}, {'cui': 'C0563537', 'cui_str': 'Mechanical vitrectomy by pars plana approach (procedure)'}, {'cui': 'C0579016', 'cui_str': 'Tamponade - action (qualifier value)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C2352201', 'cui_str': 'KH902 fusion protein'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0037111', 'cui_str': 'Silicone Oils'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity (observable entity)'}]",13.0,0.0401794,The clearance rate of anti-VEGF agents by subretinal injection was reduced in vitrectomized eyes with SiO tamponade (p < 0.05).,"[{'ForeName': 'Teng-Teng', 'Initials': 'TT', 'LastName': 'Yao', 'Affiliation': ""Department of Ophthalmology, Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': ""Department of Ophthalmology, Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Xiao-Liang', 'Initials': 'XL', 'LastName': 'Jin', 'Affiliation': ""Department of Ophthalmology, Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Yi-Xiao', 'Initials': 'YX', 'LastName': 'Wang', 'Affiliation': ""Department of Ophthalmology, Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Ya-Li', 'Initials': 'YL', 'LastName': 'Zhou', 'Affiliation': ""Department of Ophthalmology, Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.""}, {'ForeName': 'A-Jing', 'Initials': 'AJ', 'LastName': 'Xu', 'Affiliation': 'Department of Pharmacy, Xinhua Hospital, School of Medicine, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Fang-Lin', 'Initials': 'FL', 'LastName': 'He', 'Affiliation': ""Department of Ophthalmology, Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Zhao-Yang', 'Initials': 'ZY', 'LastName': 'Wang', 'Affiliation': ""Department of Ophthalmology, Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.""}]",Acta ophthalmologica,['10.1111/aos.14386']
3543,31833000,IM ketorolac vs diclofenac potassium powder for oral solution for the acute treatment of severe migraine: a randomized controlled trial.,"BACKGROUND


Diclofenac potassium for oral solution (CAMBIA®) may be an alternative for patients who would otherwise need to be seen in a healthcare setting for parenteral ketorolac. CAMBIA® is FDA-approved for the abortive treatment of migraine and has demonstrated superiority over generic diclofenac tablets with rapid migraine reduction. This study assessed for efficacy of CAMBIA® as an alternative outpatient treatment for refractory migraine to parenteral ketorolac.
METHODS


We performed an exploratory, single-center, double-blind, double-dummy randomized controlled trial comparing CAMBIA® with IM ketorolac. Participants were randomized to receive either ketorolac 60 mg IM with dummy oral solution or CAMBIA® 50 mg, together with IM injection of normal saline. The primary endpoint was headache severity, self-rated on a scale 0-3. Secondary endpoints included self-rated nausea, disability, and photo- or phonophobia, as well as presence of side effects and need for additional rescue therapy.
RESULTS


A total of 23 patients were enrolled. Ten patients received the study drug and 13 patients received IM ketorolac as the control. There were no major differences observed with respect to the primary outcome of mean headache severity at successive time points over a 24-h follow-up period. No major differences were found with respect to average disability, nausea, and photo- or phonophobia ratings. No major adverse events were reported.
CONCLUSION


In treatment of refractory migraine headache, CAMBIA® may provide similar benefits as IM ketorolac without increasing the risk of treatment failure, major bleeding, or cardiovascular events. However, larger studies are needed to confirm this finding.
TRIAL REGISTRATION


Clinicaltrials.gov: NCT # 02664116, Titled ""IM Ketorolac vs Diclofenac Potassium Powder for Oral Solution (CAMBIA®) for the Acute Treatment of Severe Migraine"". Registered 26 January 2016, https://clinicaltrials.gov/ct2/show/NCT02664116?term=02664116&rank=1.",2020,CAMBIA® is FDA-approved for the abortive treatment of migraine and has demonstrated superiority over generic diclofenac tablets with rapid migraine reduction.,"['patients who would otherwise need to be seen in a healthcare setting for parenteral ketorolac', 'severe migraine', '23 patients were enrolled']","['Diclofenac potassium for oral solution (CAMBIA®', 'diclofenac potassium powder', 'CAMBIA®', 'IM ketorolac', 'CAMBIA® with IM ketorolac', 'ketorolac 60\xa0mg IM with dummy oral solution or CAMBIA® 50\xa0mg, together with IM injection of normal saline', 'Titled ""IM Ketorolac vs Diclofenac Potassium Powder for Oral Solution (CAMBIA®']","['mean headache severity', 'average disability, nausea, and photo- or phonophobia ratings', 'risk of treatment failure, major bleeding, or cardiovascular events', 'headache severity, self-rated on a scale 0-3', 'self-rated nausea, disability, and photo- or phonophobia, as well as presence of side effects and need for additional rescue therapy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C4522267', 'cui_str': 'Parenteral (intended site)'}, {'cui': 'C0073631', 'cui_str': 'Ketorolac'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}]","[{'cui': 'C0282131', 'cui_str': 'Diclofenac Potassium'}, {'cui': 'C0991536', 'cui_str': 'Oral Solution'}, {'cui': 'C2718733', 'cui_str': 'Cambia'}, {'cui': 'C0032861', 'cui_str': 'Powdered drug preparation'}, {'cui': 'C0073631', 'cui_str': 'Ketorolac'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C1273621', 'cui_str': 'Powder for Oral Solution'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0751466', 'cui_str': 'Phonophobia'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0162643'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0222045'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",23.0,0.225106,CAMBIA® is FDA-approved for the abortive treatment of migraine and has demonstrated superiority over generic diclofenac tablets with rapid migraine reduction.,"[{'ForeName': 'Emily Rubenstein', 'Initials': 'ER', 'LastName': 'Engel', 'Affiliation': 'Dalessio Headache Center Scripps Clinic Division of Neurology, 10666 North Torrey Pines Rd. MS 313, La Jolla, CA, 92037, USA. Engel.Emily@scrippshealth.org.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Cheng', 'Affiliation': 'Scripps Green Hospital, SCMG Hospitalists, 10666 N. Torrey Pines Rd, La Jolla, CA, 92037, USA.'}]",Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology,['10.1007/s10072-019-04157-y']
3544,32012409,"Tamsulosin and placebo vs tamsulosin and tadalafil in male lower urinary tract symptoms: a double-blinded, randomised controlled trial.","OBJECTIVE


To compare the efficacy and safety of tamsulosin vs the combination of tamsulosin and tadalafil in male lower urinary tract symptoms (LUTS).
PATIENTS AND METHODS


This was a double-blinded, parallel-arm randomised controlled trial. Men aged >45 years with moderate LUTS and a maximum urinary flow rate (Q max  ) of 5-15 mL/s were included. One arm received 0.4 mg tamsulosin only (Group-A), while the second received 5 mg tadalafil with tamsulosin (Group-B). The primary outcome was the International Prostate Symptom Score (IPSS). Secondary outcomes were IPSS quality of life (QoL) score, five-item version of the International Index of Erectile Function (IIEF-5) score, Q max  , and post-void residual urine (PVR). Block randomisation was used. Placebo was used for blinding and allocation concealment. Intention-to-treat analysis was used for outcome measures.
RESULTS


Of the 183 men screened, 140 were randomised (71 in Group-A, 69 in Group-B); 116 (82.85%) (61 in Group-A, 55 in Group-B) completed the study. Baseline characteristics were comparable. The improvements in the IPSS, IPSS QoL score, IIEF score and Q max  were -1.69 (95% confidence interval [CI] -1.4 to -2.0), -0.70 (95% CI -0.60 to -0.80), 3.8 (95% CI 3.4-4.2) and 1.8 mL/s (95% CI 1.1-2.4) respectively, in favour of the combination group. The difference in PVR was not significant. There were no serious adverse events (AEs). The dropout rate due to AEs was 2.85%. Myalgia (five patients) was the commonest AE in the combination group.
CONCLUSION


The combination of tamsulosin and tadalafil produced significantly better improvements in LUTS, QoL, erectile function and Q max  compared to monotherapy with tamsulosin, without an increase in AEs.",2020,"The improvements in IPSS, IPSS QoL, IIEF and Qmax were -1.69(95% CI -1.4 to -2.0), -0.70","['male lower urinary tract symptoms', 'Men >45 years with moderate LUTS, peak flow rate (Qmax) of 5-15ml/s were included', 'male LUTS']","['Placebo', 'tamsulosin', 'tamsulosin and tadalafil', 'Tamsulosin and placebo', 'tadalafil with tamsulosin']","['IPSS QoL (quality of life), International Index for Erectile Function (IIEF-5) scores, Qmax and post-void residual urine (PVRU', 'efficacy and safety', 'serious adverse events', 'IPSS, IPSS QoL, IIEF and Qmax', 'dropout rate due to adverse events', 'International Prostate Symptom Score (IPSS', 'PVRU', 'adverse events', 'LUTS, QoL, erectile function and Qmax', 'Myalgia']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0574785', 'cui_str': 'Lower Urinary Tract Symptoms'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0729283', 'cui_str': 'Peak flow rate (respiratory)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0257343', 'cui_str': 'tamsulosin'}, {'cui': 'C1176316', 'cui_str': 'tadalafil'}]","[{'cui': 'C0034380'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0278024', 'cui_str': 'Residual urine'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C1998280', 'cui_str': 'International prostate symptom score (assessment scale)'}, {'cui': 'C0231528', 'cui_str': 'Muscle Pain'}]",140.0,0.55386,"The improvements in IPSS, IPSS QoL, IIEF and Qmax were -1.69(95% CI -1.4 to -2.0), -0.70","[{'ForeName': 'Santhosh', 'Initials': 'S', 'LastName': 'Nagasubramanian', 'Affiliation': 'Departments of, Department of, Urology, Christian Medical College, Vellore, India.'}, {'ForeName': 'Nirmal Thampi', 'Initials': 'NT', 'LastName': 'John', 'Affiliation': 'Departments of, Department of, Urology, Christian Medical College, Vellore, India.'}, {'ForeName': 'Belavendra', 'Initials': 'B', 'LastName': 'Antonisamy', 'Affiliation': 'Department of, Biostatistics, Christian Medical College, Vellore, India.'}, {'ForeName': 'Rajiv Paul', 'Initials': 'RP', 'LastName': 'Mukha', 'Affiliation': 'Departments of, Department of, Urology, Christian Medical College, Vellore, India.'}, {'ForeName': 'Chandra Singh', 'Initials': 'CS', 'LastName': 'Jeyachandra Berry', 'Affiliation': 'Departments of, Department of, Urology, Christian Medical College, Vellore, India.'}, {'ForeName': 'Santosh', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': 'Departments of, Department of, Urology, Christian Medical College, Vellore, India.'}, {'ForeName': 'Antony', 'Initials': 'A', 'LastName': 'Devasia', 'Affiliation': 'Departments of, Department of, Urology, Christian Medical College, Vellore, India.'}, {'ForeName': 'Nitin Sudhakar', 'Initials': 'NS', 'LastName': 'Kekre', 'Affiliation': 'Departments of, Department of, Urology, Christian Medical College, Vellore, India.'}]",BJU international,['10.1111/bju.15027']
3545,32108253,"Immediate effects of an elastic patellar brace on pain, neuromuscular activity and knee kinematics in subjects with patellofemoral pain.","INTRODUCTION


The aim of this randomized controlled trial was to investigate immediate effects of a patellar brace on pain, neuromuscular activity, and knee kinematics in subjects with patellofemoral pain syndrome.
MATERIALS AND METHODS


Fifty subjects with a diagnosis of patellofemoral pain syndrome completed 6 activities each with and without a patellar brace in a randomized order. The subjects were asked to rate their perceived pain on a Visual Analog Scale after each activity. During the activities, neuromuscular activity of vastus medialis and vastus lateralis, as well as knee angles were measured.
RESULTS


Subjects showed a statistically significant pain reduction of 33-56% on the Visual Analog Scale during all activities while wearing the brace. Two groups with different onset patterns for vastus medialis and vastus lateralis were identified: one group who activated vastus medialis prior to vastus lateralis, and one who activated vastus medialis after vastus lateralis. In the subgroup of subjects activating vastus lateralis prior to vastus medialis, bracing resulted in a significantly (p = 0.048) earlier onset of vastus medialis by 56 ms. In all but one activity, the vastus medialis/vastus lateralis ratio without the patellar brace was < 1.0 and inverted with the patellar brace > 1.0. Knee angles in the sagittal plane increased significantly with the patellar brace in two activities.
CONCLUSION


Patellofemoral bracing results in an immediate decrease of pain, an earlier onset of vastus medialis and inverted vastus medialis/vastus lateralis ratio and altered knee kinematics.",2020,"RESULTS


Subjects showed a statistically significant pain reduction of 33-56% on the Visual Analog Scale during all activities while wearing the brace.","['Fifty subjects with a diagnosis of patellofemoral pain syndrome completed 6 activities each with and without a patellar brace in a randomized order', 'subjects with patellofemoral pain syndrome', 'subjects with patellofemoral pain']","['elastic patellar brace', 'patellar brace']","['rate their perceived pain on a Visual Analog Scale', 'pain reduction', 'vastus medialis/vastus lateralis ratio without the patellar brace', 'Visual Analog Scale', 'pain, an earlier onset of vastus medialis and inverted vastus medialis/vastus lateralis ratio and altered knee kinematics', 'pain, neuromuscular activity and knee kinematics', 'pain, neuromuscular activity, and knee kinematics']","[{'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0877149', 'cui_str': 'Patellofemoral Pain Syndrome'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0006086', 'cui_str': 'Braces'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0006086', 'cui_str': 'Braces'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0224445', 'cui_str': 'Vastus Medialis'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0006086', 'cui_str': 'Braces'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}, {'cui': 'C4522321', 'cui_str': 'Inverted (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",50.0,0.0227973,"RESULTS


Subjects showed a statistically significant pain reduction of 33-56% on the Visual Analog Scale during all activities while wearing the brace.","[{'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Kölle', 'Affiliation': 'Institut für Rehabilitationsmedizinische Forschung an der Universität Ulm, Am Kurpark 1, 88422, Bad Buchau, Germany. theresa.koelle@ifr-ulm.de.'}, {'ForeName': 'Wilfried', 'Initials': 'W', 'LastName': 'Alt', 'Affiliation': 'Institut für Sport- und Bewegungswissenschaft, Universität Stuttgart, Allmandring 28, 70569, Stuttgart, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Wagner', 'Affiliation': 'Hessingpark Clinic, Hessingstrasse 17, 86199, Augsburg, Germany.'}]",Archives of orthopaedic and trauma surgery,['10.1007/s00402-020-03378-7']
3546,32101269,Safety and Efficacy of Indocyanine Green Tracer-Guided Lymph Node Dissection During Laparoscopic Radical Gastrectomy in Patients With Gastric Cancer: A Randomized Clinical Trial.,"Importance


The application of indocyanine green (ICG) imaging in laparoscopic radical gastrectomy is in the preliminary stages of clinical practice, and its safety and efficacy remain controversial.
Objective


To investigate the safety and efficacy of ICG near-infrared tracer-guided imaging during laparoscopic D2 lymphadenectomy in patients with gastric cancer.
Design, Setting, and Participants


Patients with potentially resectable gastric adenocarcinoma (clinical tumor stage cT1-cT4a, N0/+, M0) were enrolled in a prospective randomized clinical trial at a tertiary referral teaching hospital between November 2018 and July 2019. Patients were randomly assigned to the ICG group or the non-ICG group. The number of retrieved lymph nodes, rate of lymph node noncompliance, and postoperative recovery data were compared between the groups in a modified intention-to-treat analysis. Statistical analysis was performed from August to September 2019.
Interventions


The ICG group underwent laparoscopic gastrectomy using near-infrared imaging after receiving an endoscopic peritumoral injection of ICG to the submucosa 1 day before surgery.
Main Outcomes and Measures


Total number of retrieved lymph nodes.
Results


Of 266 participants randomized, 133 underwent ICG tracer-guided laparoscopic gastrectomy, and 133 underwent conventional laparoscopic gastrectomy. After postsurgical exclusions, 258 patients were included in the modified intention-to-treat analysis, which comprised 129 patients (86 men and 43 women; mean [SD] age, 57.8 [10.7] years) in the ICG group and 129 patients (87 men and 42 women; mean [SD] age, 60.1 [9.1] years) in the non-ICG group. The mean number of lymph nodes retrieved in the ICG group was significantly more than the mean number retrieved in the non-ICG group (mean [SD], 50.5 [15.9] lymph nodes vs 42.0 [10.3] lymph nodes, respectively; P < .001). Significantly more perigastric and extraperigastric lymph nodes were retrieved in the ICG group than in the non-ICG group. In addition, the mean total number of lymph nodes retrieved in the ICG group within the scope of D2 lymphadenectomy was also significantly greater than the mean number retrieved in the non-ICG group (mean [SD], 49.6 [15.0] lymph nodes vs 41.7 [10.2] lymph nodes, respectively; P < .001). The lymph node noncompliance rate of the ICG group (41 of 129 patients [31.8%]) was lower than that of the non-ICG group (74 of 129 patients [57.4%]; P < .001). The postoperative recovery process was comparable, and no significant difference was found between the ICG and non-ICG groups in the incidence (20 of 129 patients [15.5%] vs 21 of 129 [16.3%], respectively; P = .86) or severity of complications within 30 days after surgery.
Conclusions and Relevance


Indocyanine green can noticeably improve the number of lymph node dissections and reduce lymph node noncompliance without increased complications in patients undergoing D2 lymphadenectomy. Indocyanine green fluorescence imaging can be performed for routine lymphatic mapping during laparoscopic gastrectomy, especially total gastrectomy.
Trial Registration


ClinicalTrials.gov Identifier: NCT03050879.",2020,"The postoperative recovery process was comparable, and no significant difference was found between the ICG and non-ICG groups in the incidence (20 of 129 patients [15.5%] vs 21 of 129 [16.3%], respectively; P = .86) or severity of complications within 30 days after surgery.
","['Patients With Gastric Cancer', 'patients undergoing D2 lymphadenectomy', 'Participants\n\n\nPatients with potentially resectable gastric adenocarcinoma (clinical tumor stage cT1-cT4a, N0/+, M0) were enrolled in a prospective randomized clinical trial at a tertiary referral teaching hospital between November 2018 and July 2019', '266 participants randomized, 133 underwent', 'patients with gastric cancer', '258 patients were included in the modified intention-to-treat analysis, which comprised 129 patients (86 men and 43 women; mean [SD] age, 57.8 [10.7] years) in the ICG group and 129 patients (87 men and 42 women; mean [SD] age, 60.1']","['ICG', 'ICG tracer-guided laparoscopic gastrectomy', 'ICG near-infrared tracer-guided imaging during laparoscopic D2 lymphadenectomy', 'indocyanine green (ICG) imaging', 'laparoscopic gastrectomy', 'Indocyanine Green Tracer-Guided Lymph Node Dissection', 'Indocyanine', 'Laparoscopic Radical Gastrectomy', 'conventional laparoscopic gastrectomy', 'ICG group or the non-ICG']","['severity of complications', 'mean total number of lymph nodes', 'Measures\n\n\nTotal number of retrieved lymph nodes', 'postoperative recovery process', 'mean number of lymph nodes', 'number of retrieved lymph nodes, rate of lymph node noncompliance, and postoperative recovery data', 'perigastric and extraperigastric lymph nodes', 'lymph node noncompliance rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024623', 'cui_str': 'Cancer of Stomach'}, {'cui': 'C0024203', 'cui_str': 'Lymphadenectomy'}, {'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0475455', 'cui_str': 'T category'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0020027', 'cui_str': 'Teaching Hospitals'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0017118', 'cui_str': 'Gastrectomy'}, {'cui': 'C0475806', 'cui_str': 'Nr - Near'}, {'cui': 'C0024203', 'cui_str': 'Lymphadenectomy'}, {'cui': 'C0021234', 'cui_str': 'Indocyanine Green'}, {'cui': 'C0242382', 'cui_str': 'Lymph Node Dissection'}, {'cui': 'C0565313', 'cui_str': 'Radical gastrectomy (procedure)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0024204', 'cui_str': 'Lymphatic gland'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}]",258.0,0.0898331,"The postoperative recovery process was comparable, and no significant difference was found between the ICG and non-ICG groups in the incidence (20 of 129 patients [15.5%] vs 21 of 129 [16.3%], respectively; P = .86) or severity of complications within 30 days after surgery.
","[{'ForeName': 'Qi-Yue', 'Initials': 'QY', 'LastName': 'Chen', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Jian-Wei', 'Initials': 'JW', 'LastName': 'Xie', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Zhong', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Jia-Bin', 'Initials': 'JB', 'LastName': 'Wang', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Jian-Xian', 'Initials': 'JX', 'LastName': 'Lin', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Long-Long', 'Initials': 'LL', 'LastName': 'Cao', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Mi', 'Initials': 'M', 'LastName': 'Lin', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Ru-Hong', 'Initials': 'RH', 'LastName': 'Tu', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Ze-Ning', 'Initials': 'ZN', 'LastName': 'Huang', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Ju-Li', 'Initials': 'JL', 'LastName': 'Lin', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Hua-Long', 'Initials': 'HL', 'LastName': 'Zheng', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Chao-Hui', 'Initials': 'CH', 'LastName': 'Zheng', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Chang-Ming', 'Initials': 'CM', 'LastName': 'Huang', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}]",JAMA surgery,['10.1001/jamasurg.2019.6033']
3547,31389909,Effects of Exercise Training and Statin Use in People Living with HIV with Dyslipidemia.,"PURPOSE


To evaluate the effects of the combination of ET and statins in people living with HIV.
METHODS


This was a randomized, double-blind, placebo-controlled clinical trial. Eighty-three people living with HIV were assigned to either placebo (PL), statins (STA), placebo + ET (PLET) or statins + ET (STAET) groups. Volunteers assigned to STA and STAET groups were administered 10 mg of rosuvastatin, whereas the PL and PLET groups were administered a placebo. PLET and STAET groups performed ET three times a week. Before and after the 12-week follow-up, the volunteers underwent to anthropometric assessment and blood collection to evaluate lipid profile, cardiovascular markers, inflammatory profile; a Doppler ultrasound examination, muscle strength (MS) and cardiorespiratory fitness (CF) tests were performed.
RESULTS


There was a decrease in total cholesterol (TC), triglycerides (TG), low-density lipoprotein (LDL-c), C-reactive protein, fibrinogen, interleukin (IL)-1β and right carotid intima-media thickness (cIMT) in the STA, PLET, and STAET groups compared to PL group (p<0.001). Furthermore, there was a decrease in TC, TG, LDL, IL-1β, IL-6, and IL-8 levels and in left and right cIMT and an increase in HDL-c levels in the STAET groups compared to the STA (p<0.001) and PLET groups (p<0.001). There was an increase in IL-10 levels, peak-systolic velocity, end-diastolic velocity, wall shear rate in the PLET and STAET groups compared to the PL (p<0.001) and STA groups (p<0.001). The PLET and STAET groups reduced body fat mass, body fat percentage and increased lean body mass, MS and CF compared to PL (p<0.001) and STA (p<0.001) groups.
CONCLUSION


The combination of ET and statins is useful to enhance lipid and inflammatory profiles, reduce CVD markers, and improve Doppler ultrasound findings, MS and CF in people living with HIV.",2019,"There was an increase in IL-10 levels, peak-systolic velocity, end-diastolic velocity, wall shear rate in the PLET and STAET groups compared to the PL (p<0.001) and STA groups (p<0.001).","['people living with HIV', 'People Living with HIV with Dyslipidemia', 'Eighty-three people living with HIV']","['STA', 'placebo (PL), statins (STA), placebo + ET (PLET) or statins + ET (STAET', 'rosuvastatin', 'Exercise Training and Statin Use', 'placebo', 'PLET', 'ET and statins']","['TC, TG, LDL, IL-1β, IL-6, and IL-8 levels and in left and right cIMT and an increase in HDL-c levels', 'lipid profile, cardiovascular markers, inflammatory profile; a Doppler ultrasound examination, muscle strength (MS) and cardiorespiratory fitness (CF) tests', 'IL-10 levels, peak-systolic velocity, end-diastolic velocity, wall shear rate', 'body fat mass, body fat percentage and increased lean body mass, MS and CF', 'total cholesterol (TC), triglycerides (TG), low-density lipoprotein (LDL-c), C-reactive protein, fibrinogen, interleukin (IL)-1β and right carotid intima-media thickness (cIMT']","[{'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemias'}, {'cui': 'C4517888', 'cui_str': '83'}]","[{'cui': 'C1529286', 'cui_str': 'stas'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0965129', 'cui_str': 'rosuvastatin'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C1947944', 'cui_str': 'Use'}]","[{'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0162481', 'cui_str': 'Doppler Ultrasound'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0442710', 'cui_str': 'Peak systolic, function (observable entity)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0205380', 'cui_str': 'Walled (qualifier value)'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass (observable entity)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0982156', 'cui_str': 'fibrinogen (125I)'}, {'cui': 'C0021764', 'cui_str': 'Interleukins'}, {'cui': 'C0162864', 'cui_str': 'Vascular Intima'}]",83.0,0.0940275,"There was an increase in IL-10 levels, peak-systolic velocity, end-diastolic velocity, wall shear rate in the PLET and STAET groups compared to the PL (p<0.001) and STA groups (p<0.001).","[{'ForeName': 'Hugo Ribeiro', 'Initials': 'HR', 'LastName': 'Zanetti', 'Affiliation': 'Postgraduate Program in Health Science, Faculty of Medicine, Federal University of Uberlândia, Uberlândia/MG, Brazil.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Gonçalves', 'Affiliation': 'Master Institute of Education President Antônio Carlos, Araguari/MG, Brazil.'}, {'ForeName': 'Leandro Teixeira', 'Initials': 'LT', 'LastName': 'Paranhos Lopes', 'Affiliation': 'Brazil University, Fernandópolis/SP, Brazil.'}, {'ForeName': 'Edmar Lacerda', 'Initials': 'EL', 'LastName': 'Mendes', 'Affiliation': 'Institute of Health Sciences, Department of Sport Sciences, Federal University of Triângulo Mineiro, Uberaba/MG, Brazil.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Roever', 'Affiliation': 'Postgraduate Program in Health Science, Faculty of Medicine, Federal University of Uberlândia, Uberlândia/MG, Brazil.'}, {'ForeName': 'Mário Leon', 'Initials': 'ML', 'LastName': 'Silva-Vergara', 'Affiliation': 'Institute of Health Sciences, Department of Medical Clinics, Clinics Hospital, Federal University of Triângulo Mineiro, Uberaba/MG, Brazil.'}, {'ForeName': 'Fernando Freitas', 'Initials': 'FF', 'LastName': 'Neves', 'Affiliation': 'Institute of Health Sciences, Department of Medical Clinics, Clinics Hospital, Federal University of Triângulo Mineiro, Uberaba/MG, Brazil.'}, {'ForeName': 'Elmiro Santos', 'Initials': 'ES', 'LastName': 'Resende', 'Affiliation': 'Postgraduate Program in Health Science, Faculty of Medicine, Federal University of Uberlândia, Uberlândia/MG, Brazil.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002120']
3548,32107736,Cost-Effectiveness Analysis of Supervised Exercise Training in Men with Prostate Cancer Previously Treated with Radiation Therapy and Androgen-Deprivation Therapy.,"BACKGROUND


Exercise for prostate cancer (PCa) survivors has been shown to be effective in addressing metabolic function and associated co-morbidities, as well as sarcopenia and significant functional impairment resulting from long-term androgen deprivation. Evidence on the cost-effectiveness of exercise interventions for PCa, however, is lacking, thus the aim of this study was to determine the cost-effectiveness of a supervised exercise intervention for long-term PCa survivors who previously received radiation therapy and androgen-deprivation therapy.
METHODS


Cost-effectiveness analysis from an Australian healthcare-payer perspective was conducted using patient-level data from a multicentre randomised controlled trial (RCT) of supervised exercise training (resistance and aerobic) compared to receiving printed exercise material and a recommendation to exercise in long-term PCa survivors (> 5 years post-diagnosis). Analysis was undertaken for the 6-month supervised exercise portion of the intervention, which involved 100 men aged between 62 and 85 years, 50 in each arm. The primary outcome was cost per quality-adjusted life-years (QALYs).
RESULTS


A 6-month supervised exercise intervention for PCa survivors resulted in an incremental cost-effectiveness ratio of AU$64,235 (2018 AUD) at an incremental cost of AU$546 per person and a QALY gain of 0.0085. At a willingness-to-pay of AU$50,000, the probability that the intervention is cost-effective was 41%. Sensitivity analysis showed that maintenance of benefits via a 6-month home-based intervention, immediately following the supervised intervention, lowered the cost per QALY gained to AU$32,051.
DISCUSSION


This is the first cost-effectiveness analysis of exercise for PCa survivors. The intervention was effective, but unlikely to be cost-effective at the generally accepted willingness-to-pay of AU$50,000 per QALY. It is likely that evidence to support cost savings from post-intervention outcomes would reveal greater benefits and contribute to a more comprehensive cost-effectiveness analysis. Future RCTs should incorporate longer follow-up durations and collection of data to support modelling to capture future health benefits. Measures of quality of life or utility more sensitive to the impact of physical activity would also improve future economic evaluations.",2020,"The intervention was effective, but unlikely to be cost-effective at the generally accepted willingness-to-pay of AU$50,000 per QALY.","['100 men aged between 62 and 85\xa0years, 50 in each arm', 'in long-term PCa survivors (>\u20095\xa0years post-diagnosis', 'Men with Prostate Cancer', 'prostate cancer (PCa) survivors']","['supervised exercise training (resistance and aerobic) compared to receiving printed exercise material and a recommendation to exercise', 'supervised exercise intervention', 'Supervised Exercise Training', 'radiation therapy and androgen-deprivation therapy', 'Radiation Therapy and Androgen-Deprivation Therapy']","['cost-effectiveness', 'cost per quality-adjusted life-years (QALYs', 'incremental cost-effectiveness ratio of AU$64,235 (2018 AUD']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0030625', 'cui_str': 'PCA'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0439084', 'cui_str': '>5 (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0418878', 'cui_str': 'Advice to exercise'}, {'cui': 'C0034619', 'cui_str': 'radiation therapy'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy (procedure)'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",100.0,0.0779652,"The intervention was effective, but unlikely to be cost-effective at the generally accepted willingness-to-pay of AU$50,000 per QALY.","[{'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Edmunds', 'Affiliation': 'Centre for Applied Health Economics, Griffith University, Nathan, QLD, Australia. k.edmunds@griffith.edu.au.'}, {'ForeName': 'Penny', 'Initials': 'P', 'LastName': 'Reeves', 'Affiliation': 'Hunter Medical Research Institute, New Lambton Heights, NSW, Australia.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Scuffham', 'Affiliation': 'Centre for Applied Health Economics, Griffith University, Nathan, QLD, Australia.'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Galvão', 'Affiliation': 'Exercise Medicine Research Institute, Edith Cowan University, Joondalup, WA, Australia.'}, {'ForeName': 'Robert U', 'Initials': 'RU', 'LastName': 'Newton', 'Affiliation': 'Exercise Medicine Research Institute, Edith Cowan University, Joondalup, WA, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Jones', 'Affiliation': 'Hunter Medical Research Institute, New Lambton Heights, NSW, Australia.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Spry', 'Affiliation': 'Exercise Medicine Research Institute, Edith Cowan University, Joondalup, WA, Australia.'}, {'ForeName': 'Dennis R', 'Initials': 'DR', 'LastName': 'Taaffe', 'Affiliation': 'Exercise Medicine Research Institute, Edith Cowan University, Joondalup, WA, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Joseph', 'Affiliation': 'Exercise Medicine Research Institute, Edith Cowan University, Joondalup, WA, Australia.'}, {'ForeName': 'Suzanne K', 'Initials': 'SK', 'LastName': 'Chambers', 'Affiliation': 'Faculty of Health, University of Technology, Sydney, NSW, Australia.'}, {'ForeName': 'Haitham', 'Initials': 'H', 'LastName': 'Tuffaha', 'Affiliation': 'Centre for Applied Health Economics, Griffith University, Nathan, QLD, Australia.'}]",Applied health economics and health policy,['10.1007/s40258-020-00564-x']
3549,32067724,Rhythmic auditory stimulation increases 6-Minute walk distance in individuals with COPD: A repeated measures study.,"OBJECTIVE


To evaluate if there is an increase in 6-minute walk distance in individuals with chronic obstructive pulmonary disease (COPD) while walking to rhythmically enhanced music.
BACKGROUND


Individuals with COPD are less active. Walking with rhythmically enhanced music may help Participant's walk farther while simultaneously distracting from symptoms of dyspnea.
METHODS


Twenty-five men (age = 70.7 ± 4.5 yr), with moderate-to-severe COPD (FEV1 = 47.4 ± 9.7% predicted) completed three, 6 min walk tests (6MWT) in random order. Walks were completed with music, with music that was rhythmically enhanced, or without music. Walking distance and perceived dyspnea were measured.
RESULTS


Participant's walked 12 m, 95% CI [20.5-, 2.6], p = 0.015 further during the 6MWT when listening to rhythmically enhanced music when compared to no music. Onset of dyspnea was not different between the three walking conditions.
CONCLUSIONS


Rhythmically-enhanced music may be a useful tool to increase walking distance in Participant's with COPD.",2020,"RESULTS


Participant's walked 12 m, 95% CI [20.5-, 2.6], p = 0.015 further during the 6MWT when listening to rhythmically enhanced music when compared to no music.","['Twenty-five men (age\xa0=\xa070.7\xa0±', 'individuals with chronic obstructive pulmonary disease (COPD', 'Individuals with COPD', 'individuals with COPD']","['Rhythmic auditory stimulation', 'Walking with rhythmically enhanced music']","['Onset of dyspnea', '6-Minute walk distance', 'walking distance', 'Walking distance and perceived dyspnea', '6-minute walk distance']","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}]","[{'cui': 'C0001164', 'cui_str': 'Stimulation, Auditory'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0026867', 'cui_str': 'Music'}]","[{'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}]",,0.162271,"RESULTS


Participant's walked 12 m, 95% CI [20.5-, 2.6], p = 0.015 further during the 6MWT when listening to rhythmically enhanced music when compared to no music.","[{'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Hernandez', 'Affiliation': 'Northwestern University, Feinberg School of Medicine, Center for Education in Health Science and Outcomes Research, 633 N St. Clair, 20th Floor (2024-J), Chicago, IL 60611; University of Illinois at Chicago, College of Nursing, 845 South Damen Ave, Chicago IL 60612. Electronic address: lison.hernandez@northwestern.com.'}, {'ForeName': 'Ulf G', 'Initials': 'UG', 'LastName': 'Bronas', 'Affiliation': 'University of Illinois at Chicago, College of Nursing, 845 South Damen Ave, Chicago IL 60612. Electronic address: bronas@uic.edu.'}, {'ForeName': 'Alana D', 'Initials': 'AD', 'LastName': 'Steffen', 'Affiliation': 'University of Illinois at Chicago, College of Nursing, 845 South Damen Ave, Chicago IL 60612. Electronic address: steffena@uic.edu.'}, {'ForeName': 'David X', 'Initials': 'DX', 'LastName': 'Marquez', 'Affiliation': 'University of Illinois at Chicago, Department of Kinesiology and Nutrition, 1919 W. Taylor, Chicago IL 60612. Electronic address: marquezd@uic.edu.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Fritschi', 'Affiliation': 'University of Illinois at Chicago, College of Nursing, 845 South Damen Ave, Chicago IL 60612. Electronic address: fritschi@uic.edu.'}, {'ForeName': 'Lauretta T', 'Initials': 'LT', 'LastName': 'Quinn', 'Affiliation': 'University of Illinois at Chicago, College of Nursing, 845 South Damen Ave, Chicago IL 60612. Electronic address: lquinn1@uic.edu.'}, {'ForeName': 'Eileen G', 'Initials': 'EG', 'LastName': 'Collins', 'Affiliation': 'University of Illinois at Chicago, College of Nursing, 845 South Damen Ave, Chicago IL 60612; Edward Hines Jr., VA Hospital. Electronic address: ecollins@uic.edu.'}]",Heart & lung : the journal of critical care,['10.1016/j.hrtlng.2020.01.006']
3550,32078754,The Effect of Reflexology on Lactation and Postpartum Comfort in Caesarean-Delivery Primiparous Mothers: A Randomized Controlled Study.,"AIM


This study aimed to investigate the effect of reflexology on lactation and postpartum comfort in primiparas giving births through caesarean section.
METHODS


This randomized controlled trial was conducted in 100 women with first birth through caesarean section between May 2016 and May 2017. Expectant mothers were randomly included into an intervention and a control group. The intervention group consisted of mothers in whom reflexology was performed three times per day at every eight hours for 30 min for 3 days.
RESULTS


The mean scores of the breastfeeding chart system and breastfeeding satisfaction scores of the mothers in the intervention group were significantly higher than those of the controls, and the first lactation period of the mothers in the intervention group was shorter than that of the controls. Mean breast-tension, breast-heat, and breast-pain scores were similar in both groups on day 1; however, a significant increase was seen the intervention group on days 2 and 3, compared to those in the controls. The mean scores of the Postpartum Comfort Questionnaire in the intervention group were significantly better than those of the controls.
CONCLUSIONS


Reflexology starts lactation earlier in mothers giving birth via caesarean section, supports the breastfeeding period, and increases mothers' postpartum comfort.",2020,"The mean scores of the breastfeeding chart system and breastfeeding satisfaction scores of the mothers in the intervention group were significantly higher than those of the controls, and the first lactation period of the mothers in the intervention group was shorter than that of the controls.","['Expectant mothers', 'primiparas giving births through caesarean section', 'Caesarean-Delivery Primiparous Mothers', '100 women with first birth through caesarean section between May 2016 and May 2017']","['Reflexology', 'reflexology']","['mean scores of the breastfeeding chart system and breastfeeding satisfaction scores', 'mean scores of the Postpartum Comfort Questionnaire', 'Lactation and Postpartum Comfort', 'Mean breast-tension, breast-heat, and breast-pain scores']","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0007876', 'cui_str': 'C-Section (OB)'}, {'cui': 'C1384674', 'cui_str': 'Deliveries by cesarean (finding)'}, {'cui': 'C0033150', 'cui_str': 'Primiparity'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0016145', 'cui_str': 'First Birth'}]","[{'cui': 'C0034945', 'cui_str': 'Reflexology'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C0684240', 'cui_str': 'Chart'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0022925', 'cui_str': 'Milk Secretion'}, {'cui': 'C1142383', 'cui_str': 'Breast tension'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0024902', 'cui_str': 'Mammalgia'}]",100.0,0.0258874,"The mean scores of the breastfeeding chart system and breastfeeding satisfaction scores of the mothers in the intervention group were significantly higher than those of the controls, and the first lactation period of the mothers in the intervention group was shorter than that of the controls.","[{'ForeName': 'Seyhan', 'Initials': 'S', 'LastName': 'Çankaya', 'Affiliation': 'Department of Midwifery, Health Sciences Faculty of Selcuk University, Konya, Turkey.'}, {'ForeName': 'Gülay', 'Initials': 'G', 'LastName': 'Ratwisch', 'Affiliation': 'Department of Gynecologic and Obstetrics Nursing, Florence Nightingale Nursing Faculty of Istanbul University, Istanbul, Turkey.'}]",International journal of nursing practice,['10.1111/ijn.12824']
3551,31379311,Measuring adherence in social recovery therapy with people with first episode psychosis.,"BACKGROUND


The SUPEREDEN3 study, a phase II randomized controlled trial, suggests that social recovery therapy (SRT) is useful in improving functional outcomes in people with first episode psychosis. SRT incorporates cognitive behavioural therapy (CBT) techniques with case management and employment support, and therefore has a different emphasis to traditional CBT for psychosis, requiring a new adherence tool.
AIMS


This paper describes the SRT adherence checklist and content of the therapy delivered in the SUPEREDEN3 trial, outlining the frequency of SRT techniques and proportion of participants who received a full therapy dose. It was hypothesized that behavioural techniques would be used frequently, consistent with the behavioural emphasis of SRT.
METHOD


Research therapists completed an adherence checklist after each therapy session, endorsing elements of SRT present. Data from 1236 therapy sessions were reviewed to determine whether participants received full, partial or no therapy dose.
RESULTS


Of the 75 participants randomized to receive SRT, 57.3% received a full dose, 24% a partial dose, and 18.7% received no dose. Behavioural techniques were endorsed in 50.5% of sessions, with cognitive techniques endorsed in 34.9% of sessions.
CONCLUSIONS


This report describes an adherence checklist which should be used when delivering SRT in both research and clinical practice. As hypothesized, behavioural techniques were a prominent feature of the SRT delivered in SUPEREDEN3, consistent with the behavioural emphasis of the approach. The use of this adherence tool would be considered essential for anyone delivering SRT looking to ensure adherence to the model.",2020,"Behavioural techniques were endorsed in 50.5% of sessions, with cognitive techniques endorsed in 34.9% of sessions.
",['people with first episode psychosis'],"['social recovery therapy (SRT', 'SRT']",['functional outcomes'],"[{'cui': 'C0439615', 'cui_str': 'First episode (qualifier value)'}, {'cui': 'C0033975', 'cui_str': 'Psychoses'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0234742', 'cui_str': 'Speech reception threshold (observable entity)'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]",75.0,0.0381767,"Behavioural techniques were endorsed in 50.5% of sessions, with cognitive techniques endorsed in 34.9% of sessions.
","[{'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Lowen', 'Affiliation': 'Norfolk and Suffolk Mental Health Foundation Trust, Norwich, UK.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Hodgekins', 'Affiliation': 'Department of Clinical Psychology, Norwich Medical School, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Pugh', 'Affiliation': 'Sussex Partnership NHS Foundation Trust, Worthing, UK.'}, {'ForeName': 'Clio', 'Initials': 'C', 'LastName': 'Berry', 'Affiliation': 'Sussex Partnership NHS Foundation Trust, Worthing, UK.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Fitzsimmons', 'Affiliation': 'Lancashire Care NHS Foundation Trust, Preston, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'French', 'Affiliation': 'Psychosis Research Unit, Greater Manchester Mental Health NHS Trust, Manchester, UK.'}, {'ForeName': 'Catarina', 'Initials': 'C', 'LastName': 'Sacadura', 'Affiliation': 'Sussex Partnership NHS Foundation Trust, Worthing, UK.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Birchwood', 'Affiliation': 'University of Warwick, Warwick, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Jackson', 'Affiliation': ""Birmingham Women's and Children's NHS Foundation Trust, Birmingham, UK.""}, {'ForeName': 'Eleanor', 'Initials': 'E', 'LastName': 'Baggott', 'Affiliation': 'Canterbury District Health Board, Christchurch, New Zealand.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Bernard', 'Affiliation': ""Birmingham Women's and Children's NHS Foundation Trust, Birmingham, UK.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Fowler', 'Affiliation': 'University of Sussex, Brighton, UK.'}]",Behavioural and cognitive psychotherapy,['10.1017/S1352465819000432']
3552,31375459,Effects of cryolipolysis on lower abdomen fat thickness of healthy women and patient satisfaction: a randomized controlled trial.,"OBJECTIVE


To analyze the effects of cryolipolysis on the fat thickness of the lower abdomen of healthy women and patient's satisfaction.
METHODS


Design and setting: a randomized controlled trial, with concealed allocation and blinded assessor.
PARTICIPANTS


34 healthy women between 18 and 48 years, skinfold in the lower abdomen ≥3cm, BMI between 18.5 and 27kg/m 2 , low level of physical activity, and no contraindication to cryolipolysis were allocated to intervention group (IG, n=17) or control group (CG, n=17).
INTERVENTIONS


The IG received one session of cryolipolysis with -10°C of temperature for 50min. The CG was not submitted to any kind of intervention. Both groups did the evaluation protocols at baseline, 30, 60 and 90 days after the intervention.
MAIN OUTCOME MEASURES


fat thickness was measured by ultrasonography (US), skinfold (SF) and abdominal circumference (AC1 and AC2).
RESULTS


No significant differences between the IG and CG were demonstrated at any evaluation at any time of follow up for the variables US (30 days: 0.05cm (95%CI: -0.12; 0.22), 60 days: 0.05cm (95%CI: -0.11; 0.20) and 90 days: 0.04cm (95%CI: -0.7; 0.25)), SF (30 days: -0.09cm (95%CI: -0.25; 0.08), 60 days: -0.14cm (95%CI: -0.36; 0.09) and 90 days: -0.001cm (95%CI: -0.237; 0.234)), AC1 (30 days: 0.42cm (95%CI: -1.1; 1.9), 60 days: -0.1cm (95%CI: -1.74; 1.54) and 90 days: -0.007cm (-1.9; 1.9)) and AC2 (30 days: 0.183cm (95%CI: -0.84; 1.20), 60 days: -0.13cm (95%CI: -1.61; 1.35) and 90 days: -0.31cm (95%CI: -1.61; 1.00)).
CONCLUSIONS


The current study showed that a single application of the utilized protocol of cryolipolysis does not produce any significant effect on fat thickness of the lower abdomen of healthy women.
CLINICAL TRIAL REGISTRATION NUMBER


NCT03160976 (https://clinicaltrials.gov/ct2/show/NCT03160976). Contribution of the Paper: the study is one of the first studies in the literature with methodological rigor to report an unfavorable result for localized abdominal fat treatment with a single session of cryolipolysis.",2020,"No significant differences between the IG and CG were demonstrated at any evaluation at any time of follow up for the variables US (30 days: 0.05 cm (95%CI: -0.12; 0.22), 60 days: 0.05 cm (95%CI: -0.11; 0.20) and 90 days: 0.04 cm (95%CI: -0.7; 0.25)), SF (30 days: -0.09 cm (95%CI:-0.25; 0.08), 60 days: -0.14 cm (95%CI: -0.36; 0.09) and 90 days: -0.001 cm (95%CI: -0.237; 0.234)), AC1 (30 days: 0.42 cm (95%CI: -1.1; 1.9), 60 days: -0.1 cm (95%CI: -1.74; 1.54) and 90 days: -0.007 cm (-1.9; 1.9)) and AC2 (30 days: 0.183 cm (95%CI: -0.84; 1.20), 60 days: -0.13 cm (95%CI: -1.61; 1.35) and 90 days: -0.31 cm (95%CI: -1.61; 1.00)).
","['healthy women and patient satisfaction', ""healthy women and patient's satisfaction"", 'healthy women', '34 healthy women between 18 and 48 years, skinfold in the lower abdomen ≥ 3\u202fcm, Body Mass Index between 18.5 and 27\u202fkg / m², low level of physical activity, and no contraindication to cryolipolysis']","['intervention group (IG, n\u202f=\u202f17) or control group (CG, n\u202f=\u202f17', 'cryolipolysis']","['fat thickness was measured by ultrassonography (US), skinfold (SF) and abdominal circumference (AC1 and AC2', 'lower abdomen fat thickness']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517611', 'cui_str': 'Eighteen point five'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1300813', 'cui_str': 'Abdominal circumference (observable entity)'}, {'cui': 'C0391363', 'cui_str': 'adenylyl cyclase type 2'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}]",34.0,0.269973,"No significant differences between the IG and CG were demonstrated at any evaluation at any time of follow up for the variables US (30 days: 0.05 cm (95%CI: -0.12; 0.22), 60 days: 0.05 cm (95%CI: -0.11; 0.20) and 90 days: 0.04 cm (95%CI: -0.7; 0.25)), SF (30 days: -0.09 cm (95%CI:-0.25; 0.08), 60 days: -0.14 cm (95%CI: -0.36; 0.09) and 90 days: -0.001 cm (95%CI: -0.237; 0.234)), AC1 (30 days: 0.42 cm (95%CI: -1.1; 1.9), 60 days: -0.1 cm (95%CI: -1.74; 1.54) and 90 days: -0.007 cm (-1.9; 1.9)) and AC2 (30 days: 0.183 cm (95%CI: -0.84; 1.20), 60 days: -0.13 cm (95%CI: -1.61; 1.35) and 90 days: -0.31 cm (95%CI: -1.61; 1.00)).
","[{'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Falster', 'Affiliation': 'Department of Physical Therapy, Universidade Federal de Ciências da Sáude de Porto Alegre (UFCSPA), Porto Alegre, RS, Brazil.'}, {'ForeName': 'Jociane', 'Initials': 'J', 'LastName': 'Schardong', 'Affiliation': 'Department of Physical Therapy, Universidade Federal de Ciências da Sáude de Porto Alegre (UFCSPA), Porto Alegre, RS, Brazil.'}, {'ForeName': 'Débora Piassarollo Dos', 'Initials': 'DPD', 'LastName': 'Santos', 'Affiliation': 'Department of Physical Therapy, Universidade Federal de Ciências da Sáude de Porto Alegre (UFCSPA), Porto Alegre, RS, Brazil.'}, {'ForeName': 'Bruna Coimbra', 'Initials': 'BC', 'LastName': 'Machado', 'Affiliation': 'Department of Physical Therapy, Universidade Federal de Ciências da Sáude de Porto Alegre (UFCSPA), Porto Alegre, RS, Brazil.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Peres', 'Affiliation': 'Department of Basic Health Sciences, Universidade Federal de Ciências da Sáude de Porto Alegre (UFCSPA), Porto Alegre, RS, Brazil.'}, {'ForeName': 'Patrícia Viana da', 'Initials': 'PVD', 'LastName': 'Rosa', 'Affiliation': 'Department of Physical Therapy, Universidade Federal de Ciências da Sáude de Porto Alegre (UFCSPA), Porto Alegre, RS, Brazil.'}, {'ForeName': 'Rodrigo Della Méa', 'Initials': 'RDM', 'LastName': 'Plentz', 'Affiliation': 'Department of Physical Therapy, Universidade Federal de Ciências da Sáude de Porto Alegre (UFCSPA), Porto Alegre, RS, Brazil. Electronic address: roplentz@yahoo.com.br.'}]",Brazilian journal of physical therapy,['10.1016/j.bjpt.2019.07.005']
3553,31525489,Peer mentorship to reduce suicide attempts among high-risk adults (PREVAIL): Rationale and design of a randomized controlled effectiveness-implementation trial.,"RATIONALE


Novel approaches to suicide prevention are needed to address increasing rates of suicide deaths. Research suggests that interventions led by certified Peer Specialists may improve suicide protective factors such as hope and connectedness; however, the effectiveness of a Peer Specialist intervention for reducing suicidal thoughts or behaviors has not previously been tested empirically.
DESIGN


We describe the methodology of a randomized controlled hybrid effectiveness-implementation trial of a peer specialist intervention known as PREVAIL (Peers for Valued Living). The primary effectiveness aim is to determine whether the 3-month peer mentorship intervention compared to a minimally enhanced usual care condition reduces suicide attempts and suicidal ideation among adults at high risk for suicide who have been psychiatrically hospitalized. Secondary effectiveness outcomes include medically serious suicide attempts according to chart review and self-reported self-efficacy to avoid suicide. We also describe suicide risk management, supervision, and fidelity monitoring in the context of Peer Specialist providers and our methods for assessing implementation barriers and facilitators.
CONCLUSION


The PREVAIL trial will demonstrate novel methods for incorporating peer providers into a suicide prevention effectiveness trial with high-risk study participants. PREVAIL's hybrid effectiveness-implementation design aims to maximize the likelihood of rapid implementation in the community if shown to be effective.",2019,The primary effectiveness aim is to determine whether the 3-month peer mentorship intervention compared to a minimally enhanced usual care condition reduces suicide attempts and suicidal ideation among adults at high risk for suicide who have been psychiatrically hospitalized.,"['adults at high risk for suicide who have been psychiatrically hospitalized', 'high-risk adults (PREVAIL', 'Peers for Valued Living']","['Peer mentorship', 'peer mentorship intervention', 'Peer Specialist intervention', 'minimally enhanced usual care condition']",['medically serious suicide attempts according to chart review and self-reported self-efficacy to avoid suicide'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0852733', 'cui_str': 'Suicide (accomplished)'}, {'cui': 'C3152857', 'cui_str': 'Prevail'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]","[{'cui': 'C0025370', 'cui_str': 'Mentorships'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0038663', 'cui_str': 'Suicide attempt (event)'}, {'cui': 'C0541653', 'cui_str': 'Chart review'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0852733', 'cui_str': 'Suicide (accomplished)'}]",,0.132837,The primary effectiveness aim is to determine whether the 3-month peer mentorship intervention compared to a minimally enhanced usual care condition reduces suicide attempts and suicidal ideation among adults at high risk for suicide who have been psychiatrically hospitalized.,"[{'ForeName': 'Adrienne', 'Initials': 'A', 'LastName': 'Lapidos', 'Affiliation': 'University of Michigan Medical School, Department of Psychiatry, Ann Arbor, MI, United States. Electronic address: alapidos@umich.edu.'}, {'ForeName': 'Kristen M', 'Initials': 'KM', 'LastName': 'Abraham', 'Affiliation': 'VA Center for Clinical Management Research, Ann Arbor, MI, United States; University of Detroit Mercy, Department of Psychology, Detroit, MI, United States.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Jagusch', 'Affiliation': 'University of Michigan Medical School, Department of Psychiatry, Ann Arbor, MI, United States; VA Center for Clinical Management Research, Ann Arbor, MI, United States.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Garlick', 'Affiliation': 'University of Michigan Medical School, Department of Psychiatry, Ann Arbor, MI, United States; VA Center for Clinical Management Research, Ann Arbor, MI, United States.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Walters', 'Affiliation': 'University of Michigan Medical School, Department of Psychiatry, Ann Arbor, MI, United States; VA Center for Clinical Management Research, Ann Arbor, MI, United States.'}, {'ForeName': 'H Myra', 'Initials': 'HM', 'LastName': 'Kim', 'Affiliation': 'VA Center for Clinical Management Research, Ann Arbor, MI, United States; Consulting for Statistics, Computing & Analytics Research, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Vega', 'Affiliation': 'Humannovations, Los Angeles, CA, United States.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Damschroder', 'Affiliation': 'VA Center for Clinical Management Research, Ann Arbor, MI, United States.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Forman', 'Affiliation': 'VA Center for Clinical Management Research, Ann Arbor, MI, United States.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Ahmedani', 'Affiliation': 'Henry Ford Health System, Detroit, MI, United States.'}, {'ForeName': 'Cheryl A', 'Initials': 'CA', 'LastName': 'King', 'Affiliation': 'University of Michigan Medical School, Department of Psychiatry, Ann Arbor, MI, United States.'}, {'ForeName': 'Paul N', 'Initials': 'PN', 'LastName': 'Pfeiffer', 'Affiliation': 'University of Michigan Medical School, Department of Psychiatry, Ann Arbor, MI, United States; VA Center for Clinical Management Research, Ann Arbor, MI, United States.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105850']
3554,32078058,Cost-effectiveness analysis of voice rehabilitation for patients with laryngeal cancer: a randomized controlled study.,"INTRODUCTION


Voice problems are common following radiotherapy for laryngeal cancer. Few studies exist covering the effect of voice rehabilitation, and no previous studies exist regarding the cost of said rehabilitation. This randomized controlled study aimed to analyze the cost-effectiveness of voice rehabilitation after radiotherapy for patients with laryngeal cancer.
MATERIAL AND METHODS


A total of 66 patients with laryngeal cancer with follow-up data 12 months post-radiotherapy were included. Patients were randomized into receiving either voice rehabilitation (n = 32) or no voice rehabilitation (n = 34). The patient outcome was measured as quality-adjusted life years (QALYs). The index range between 0 and 1, where 0 equals death and 1 represents perfect health. The QALYs were assessed with the European Organization for Research and Treatment of Cancer questionnaire QLQ-C30 mapped to EuroQoL 5 Dimension values. The cost of rehabilitation and other healthcare visits was derived from hospital systems. The patients reported the total amount of sick leave days during the first 12 months following radiotherapy. The cost-effectiveness of the voice rehabilitation was compared with no rehabilitation intervention based on the incremental cost-effectiveness ratio.
RESULTS


The cost per gained QALY with voice rehabilitation compared to no rehabilitation from a societal perspective was - 27,594 € (SEK - 250,852) which indicates that the voice rehabilitation is a cost-saving alternative compared to no rehabilitation due to lower costs and a slightly better health outcome. From a healthcare perspective, the voice rehabilitation indicates a cost 60,800 € (SEK 552,725) per gained QALY.
CONCLUSION


From a societal perspective, i.e., including the costs of production loss, voice rehabilitation compared to no voice rehabilitation following radiotherapy for laryngeal cancer seems to be cost-saving. When analyzing only the healthcare costs in relation to health outcomes, voice rehabilitation indicates an incremental cost of 60,800 € per gained QALY, which is just above the threshold of the maximum willingness to pay level.",2020,"The cost per gained QALY with voice rehabilitation compared to no rehabilitation from a societal perspective was - 27,594 € (SEK - 250,852) which indicates that the voice rehabilitation is a cost-saving alternative compared to no rehabilitation due to lower costs and a slightly better health outcome.","['patients with laryngeal cancer', '66 patients with laryngeal cancer with follow-up data 12\xa0months post-radiotherapy were included']","['voice rehabilitation after radiotherapy', 'voice rehabilitation (n\u2009=\u200932) or no voice rehabilitation', 'radiotherapy', 'voice rehabilitation']","['cost-effectiveness', 'total amount of sick leave days', 'quality-adjusted life years (QALYs', 'cost of rehabilitation and other healthcare visits']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007107', 'cui_str': 'Cancer of Larynx'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0242807', 'cui_str': 'Sick Leave'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}]",66.0,0.0321077,"The cost per gained QALY with voice rehabilitation compared to no rehabilitation from a societal perspective was - 27,594 € (SEK - 250,852) which indicates that the voice rehabilitation is a cost-saving alternative compared to no rehabilitation due to lower costs and a slightly better health outcome.","[{'ForeName': 'Mia', 'Initials': 'M', 'LastName': 'Johansson', 'Affiliation': 'Department of Oncology, Institute of Clinical Sciences, Sahlgrenska Academy at the Gothenburg University, Gothenburg, Sweden.'}, {'ForeName': 'Caterina', 'Initials': 'C', 'LastName': 'Finizia', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck surgery, Institute of Clinical Sciences, Sahlgrenska Academy, Gothenburg University, Gothenburg, Sweden.'}, {'ForeName': 'Josefine', 'Initials': 'J', 'LastName': 'Persson', 'Affiliation': 'Health Economics and Policy, School of Public Health and Community Medicine, Institute of Medicine, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Tuomi', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck surgery, Institute of Clinical Sciences, Sahlgrenska Academy, Gothenburg University, Gothenburg, Sweden. lisa.tuomi@gu.se.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-020-05362-8']
3555,31364148,[Rehabilitation of anosognosia in patients with unilateral visuospatial neglect].,"INTRODUCTION


Patients with unilateral visuospatial neglect secondary to a stroke are usually unaware of the fact that their perception and exploration of contralesional space are deficient. This clinical phenomenon, know as anosognosia, directly conditions the rehabilitation process and prolongs its duration to a significant extent, while also making it more difficult for the patient to adhere to it.
AIM


To assess the efficacy of a specific rehabilitation programme for the treatment of anosognosia in patients presenting with unilateral visuospatial neglect.
PATIENTS AND METHODS


Twelve patients with a stroke in the right hemisphere were divided into two groups. The experimental group received 15 sessions of computerised cognitive therapy along with 15 sessions of specific rehabilitation for anosognosia. The control group underwent 15 sessions of computerised cognitive treatment. All of them were administered, before and after treatment, a battery of tests to evaluate visuospatial attention. The level of functionality was evaluated by means of the Catherine Bergego Scale.
RESULTS


After the intervention, the control group showed statistically significant psychometric differences. The same did not occur with the experimental group. No differences were obtained in the pre- and post-treatment intergroup comparisons, or in the psychometric measures or on the functional scale.
CONCLUSIONS


Further research is needed to help us improve the treatment of anosognosia in patients with unilateral visuospatial neglect. Some methodological recommendations emerge from the limitations identified in this study.",2019,"No differences were obtained in the pre- and post-treatment intergroup comparisons, or in the psychometric measures or on the functional scale.
","['patients presenting with unilateral visuospatial neglect', 'Twelve patients with a stroke in the right hemisphere', 'patients with unilateral visuospatial neglect']","['15 sessions of computerised cognitive therapy along with 15 sessions of specific rehabilitation for anosognosia', 'specific rehabilitation programme', 'computerised cognitive treatment']",['level of functionality'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0521874', 'cui_str': 'Victim of neglect'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0234507', 'cui_str': 'Anosognosia'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.0146602,"No differences were obtained in the pre- and post-treatment intergroup comparisons, or in the psychometric measures or on the functional scale.
","[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Aparicio-Lopez', 'Affiliation': 'Institut Universitari de Neurorehabilitacio Guttmann-UAB, Badalona, Espana.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Rodriguez-Rajo', 'Affiliation': 'Institut Universitari de Neurorehabilitacio Guttmann-UAB, Badalona, Espana.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Sanchez-Carrion', 'Affiliation': 'Institut Universitari de Neurorehabilitacio Guttmann-UAB, Badalona, Espana.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ensenat', 'Affiliation': 'Institut Universitari de Neurorehabilitacio Guttmann-UAB, Badalona, Espana.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Garcia-Molina', 'Affiliation': 'Institut Universitari de Neurorehabilitacio Guttmann-UAB, Badalona, Espana.'}]",Revista de neurologia,['10.33588/rn.6905.2019090']
3556,31423955,I am a total failure: associations between beliefs and anxiety and depression in patients with inflammatory bowel disease with poor mental quality of life.,"BACKGROUND


According to cognitive behavioural theory, cognitive factors (i.e. underlying general dysfunctional beliefs and (situation) specific illness beliefs) are theorized to lead to outcomes like anxiety and depression. In clinical practice, general dysfunctional beliefs are generally not tackled directly in short-term-therapy.
AIMS


The goal of the present study was to investigate the associations of general versus specific illness beliefs on anxiety and depressive symptoms and psychiatric disorders among a subgroup of patients with inflammatory bowel disease (IBD) with poor mental quality of life (QoL).
METHOD


This study concerns cross-sectional data, collected at baseline from a randomized clinical trial. One hundred and eighteen patients, recruited at four Dutch hospitals, with poor QoL (score ≤23 on the mental health subscale of the Short-Form 36-item Health-Survey; SF-36) were included. General dysfunctional beliefs were measured by the Dysfunctional Attitude Scale (DAS), specific illness beliefs by the Illness Perceptions Questionnaire-Revised (IPQ-R), anxiety and depressive symptoms by the Hospital Anxiety and Depression Scale (HADS), and psychiatric disorders by the Structured Clinical Interview for DSM-IV Axis-I Disorders (SCID-I).
RESULTS


Univariate analyses showed associations between the level of anxiety and/or depression and general dysfunctional beliefs and four specific illness beliefs (consequences, personal control, emotional representations and treatment control). Among patients with IBD with psychiatric disorders, only the DAS was significantly associated with anxiety and depression (DAS added to IPQ-R and IPQ-R added to DAS).
CONCLUSIONS


Psychological interventions may have to target general dysfunctional beliefs of patients with IBD with co-morbid psychiatric disorders to be effective. These patients with IBD are especially in need of psychological treatment.",2020,"Among patients with IBD with psychiatric disorders, only the DAS was significantly associated with anxiety and depression (DAS added to IPQ-R and IPQ-R added to DAS).
","['One hundred and eighteen patients, recruited at four Dutch hospitals, with poor QoL (score ≤23 on the mental health subscale of the Short-Form 36-item Health-Survey; SF-36) were included', 'patients with inflammatory bowel disease with poor mental quality of life', 'patients with inflammatory bowel disease (IBD) with poor mental quality of life (QoL', 'patients with IBD with psychiatric disorders', 'patients with IBD with co-morbid psychiatric disorders']",[],"['level of anxiety and/or depression and general dysfunctional beliefs and four specific illness beliefs (consequences, personal control, emotional representations and treatment control', 'General dysfunctional beliefs', 'anxiety and depressive symptoms and psychiatric disorders', 'anxiety and depression (DAS added to IPQ-R and IPQ-R added to DAS', 'Dysfunctional Attitude Scale (DAS), specific illness beliefs by the Illness Perceptions Questionnaire-Revised (IPQ-R), anxiety and depressive symptoms by the Hospital Anxiety and Depression Scale (HADS), and psychiatric disorders by the Structured Clinical Interview for DSM-IV Axis-I Disorders (SCID-I']","[{'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0013331', 'cui_str': 'Dutch (ethnic group)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory Bowel Diseases'}, {'cui': 'C0034380'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}]",[],"[{'cui': 'C0564474', 'cui_str': 'Level of anxiety (observable entity)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C0051767', 'cui_str': 'DASD'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0222045'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C0199182', 'cui_str': 'Taking health history'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0004457', 'cui_str': 'C2 Vertebra'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0085110', 'cui_str': 'Severe Combined Immunologic Deficiency'}]",118.0,0.0284357,"Among patients with IBD with psychiatric disorders, only the DAS was significantly associated with anxiety and depression (DAS added to IPQ-R and IPQ-R added to DAS).
","[{'ForeName': 'Floor', 'Initials': 'F', 'LastName': ""Bennebroek Evertsz'"", 'Affiliation': 'Department of Medical Psychology, Amsterdam University of Medical Centres, University of Amsterdam, Meibergdreef 15, 1105 AZ Amsterdam, The Netherlands.'}, {'ForeName': 'Mirjam A G', 'Initials': 'MAG', 'LastName': 'Sprangers', 'Affiliation': 'Department of Medical Psychology, Amsterdam University of Medical Centres, University of Amsterdam, Meibergdreef 15, 1105 AZ Amsterdam, The Netherlands.'}, {'ForeName': 'Laura M', 'Initials': 'LM', 'LastName': 'de Vries', 'Affiliation': 'Department of Medical Psychology, Amsterdam University of Medical Centres, Vrije University of Amsterdam, De Boelelaan 1118, 1081 HZ, Amsterdam, The Netherlands.'}, {'ForeName': 'Robbert', 'Initials': 'R', 'LastName': 'Sanderman', 'Affiliation': 'Department of Health Psychology, University Medical Centre Groningen, University of Groningen, Antonius Deusinglaan 1, 9713 AV, Groningen, The Netherlands.'}, {'ForeName': 'Pieter C F', 'Initials': 'PCF', 'LastName': 'Stokkers', 'Affiliation': 'Department of Gastroenterology, Sint Lucas Andreas Hospital, Jan Tooropstraat 164, 1061 AE, Amsterdam, The Netherlands.'}, {'ForeName': 'Mathilde G E', 'Initials': 'MGE', 'LastName': 'Verdam', 'Affiliation': 'Department of Medical Psychology, Amsterdam University of Medical Centres, University of Amsterdam, Meibergdreef 15, 1105 AZ Amsterdam, The Netherlands.'}, {'ForeName': 'Huibert', 'Initials': 'H', 'LastName': 'Burger', 'Affiliation': 'Department of General Practice, University Medical Centre, University of Groningen, Antonius Deusinglaan 1, 9713 AV Groningen, The Netherlands.'}, {'ForeName': 'Claudi L H', 'Initials': 'CLH', 'LastName': 'Bockting', 'Affiliation': 'Department of Psychiatry, Amsterdam University of Medical Centres, University of Amsterdam, Meibergdreef 15,1105 AZ Amsterdam, The Netherlands.'}]",Behavioural and cognitive psychotherapy,['10.1017/S1352465819000444']
3557,31978843,Comparison of PechaKucha and traditional PowerPoint presentations in nursing education: A randomized controlled study.,"This study aims to compare the effects of PechaKucha and traditional PowerPoint presentations on the learning performance of nursing students. This randomized controlled trial study was conducted in March 2016 at a nursing school in Ankara, Turkey. The participants were randomly distributed to the intervention group, which received a lecture using the PechaKucha presentation method (n = 66), and to the control group, which received a lecture using the traditional PowerPoint presentation (n = 68). The subject, ""Knee Prosthesis and Nursing Approaches,"" was given to both groups in different classrooms at the same time. The efficiency of the presentation methods was evaluated by a test on the content of the lecture. Satisfaction levels of the participants were evaluated by using the Visual Analogue Scale. There was no statistically significant relationship between the average test results of the groups. The satisfaction levels of the participants in the intervention group was higher than the control group (p < 0.01). This study showed that, although there was no difference between groups in terms of information, the PechaKucha technique can be used for topics that nurse educators want to draw particular attention to.",2020,The satisfaction levels of the participants in the intervention group was higher than the control group (p < 0.01).,"['nursing education', 'nursing students', 'March 2016\xa0at a nursing school in Ankara, Turkey']","['lecture using the PechaKucha presentation method (n\xa0=\xa066), and to the control group, which received a lecture using the traditional PowerPoint presentation', 'PechaKucha', 'PechaKucha and traditional PowerPoint presentations']","['Satisfaction levels', 'satisfaction levels', 'Visual Analogue Scale']","[{'cui': 'C0013636', 'cui_str': 'Education, Nursing'}, {'cui': 'C0038496', 'cui_str': 'Pupil Nurses'}, {'cui': 'C0036380', 'cui_str': 'Nurse Training Schools'}, {'cui': 'C0041400', 'cui_str': 'Turkey'}]","[{'cui': 'C0376683', 'cui_str': 'Lecture'}, {'cui': 'C0449450', 'cui_str': 'Presentation (attribute)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",,0.0199197,The satisfaction levels of the participants in the intervention group was higher than the control group (p < 0.01).,"[{'ForeName': 'Ozgu', 'Initials': 'O', 'LastName': 'Bakcek', 'Affiliation': 'Gulhane Faculty of Nursing, Health Sciences University, Turkey. Electronic address: bakcek.ozgu@gmail.com.'}, {'ForeName': 'Sevinc', 'Initials': 'S', 'LastName': 'Tastan', 'Affiliation': 'Eastern Mediterranean University, Health Sciences Faculty, Nursing Department, Via Mersin 10, Famagusta, North Cyprus, Turkey. Electronic address: sevinc.tastan@emu.edu.tr.'}, {'ForeName': 'Emine', 'Initials': 'E', 'LastName': 'Iyigun', 'Affiliation': 'Gulhane Faculty of Nursing, Health Sciences University, Turkey. Electronic address: emine.iyigun@sbu.edu.tr.'}, {'ForeName': 'Pervin', 'Initials': 'P', 'LastName': 'Kurtoglu', 'Affiliation': 'Gulhane Training and Research Hospital, Department of General Surgery, Ankara/Turkey. Electronic address: pervingky@gmail.com.'}, {'ForeName': 'Birhan', 'Initials': 'B', 'LastName': 'Tastan', 'Affiliation': 'Girne American University, Department of Banking and Finance, Girne, North Cyprus, Via Mersin 10, Turkey. Electronic address: birhantastan@gau.edu.tr.'}]",Nurse education in practice,['10.1016/j.nepr.2020.102695']
3558,31548616,Effect of self-initiated and fully-automated self-measurement on blood pressure.,"Self-measurement of blood pressure (BP) is regularly used to diagnose hypertension and to monitor BP at home. We recently showed that self-measurement of BP may elicit a pressor or 'auto-cuff' response. In this study we examined whether the pressor response is different between self-initiated and fully-automated BP measurement. We performed two randomized crossover studies in outpatients visiting a hypertension clinic. The first cohort of 52 participants performed six unattended self-initiated and six fully-automated BP measurements, while continuously monitoring BP and central haemodynamics using finger photoplethysmography. The second cohort consisted of 120 patients who performed three self-initiated and three fully-automated BP measurements. In the first cohort (mean age 61.2 ± 10.4 years, mean office BP 142.0 ± 19.9/82.5 ± 12.2 mmHg, 36.7% female) average systolic and diastolic BP increased by 7.3 ± 8.5/3.3 ± 4.0 mmHg in the group with self-initiated BP measurements, while BP increased by 3.3 ± 6.3/1.4 ± 3.0 mmHg during fully-automated measurements (p = 0.002/p = 0.002 for difference between groups). The higher BP increase during self-initiated BP measurements resulted from an increase in heart rate and cardiac output. In the second cohort (mean age 58.0 ± 14.1 years, mean office BP 153.6 ± 23.8/86.3 ± 14.0 mmHg, 44.1% female) self-initiated BP measurement resulted in a 2.1 ± 6.8/0.9 ± 4.0 mmHg higher systolic and diastolic BP compared with fully-automated self-measurement (p = 0.001/0.018). In conclusion, our findings suggest that self-initiated BP measurement using a fully-automated method results in a more reliable BP compared with a self-initiated semi-automated method by attenuating the auto-cuff response. These findings may have implications for the self-measurement of BP.",2020,"The first cohort of 52 participants performed six unattended self-initiated and six fully-automated BP measurements, while continuously monitoring BP and central haemodynamics using finger photoplethysmography.","['outpatients visiting a hypertension clinic', '120 patients who performed three self-initiated and three fully-automated BP measurements', 'In the second cohort (mean age 58.0\u2009±\u200914.1 years, mean office BP 153.6\u2009±\u200923.8/86.3\u2009±\u200914.0\u2009mmHg, 44.1% female']",['self-initiated and fully-automated self-measurement'],"['blood pressure', 'systolic and diastolic BP', 'heart rate and cardiac output', 'pressor response', 'self-initiated BP measurement', 'Self-measurement of blood pressure (BP']","[{'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C3715181', 'cui_str': 'Hypertension clinic (environment)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0442603', 'cui_str': 'Office (environment)'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0007165', 'cui_str': 'Cardiac Output'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}]",52.0,0.024403,"The first cohort of 52 participants performed six unattended self-initiated and six fully-automated BP measurements, while continuously monitoring BP and central haemodynamics using finger photoplethysmography.","[{'ForeName': 'Rosanne T', 'Initials': 'RT', 'LastName': 'Berkhof', 'Affiliation': 'Department of Vascular Medicine, Amsterdam UMC location Academic Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Katia', 'Initials': 'K', 'LastName': 'Gazzola', 'Affiliation': 'Department of Vascular Medicine, Amsterdam UMC location Academic Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Bert-Jan H', 'Initials': 'BH', 'LastName': 'van den Born', 'Affiliation': 'Department of Vascular Medicine, Amsterdam UMC location Academic Medical Center, Amsterdam, The Netherlands. b.j.vandenborn@amsterdamumc.nl.'}]",Journal of human hypertension,['10.1038/s41371-019-0256-1']
3559,31571349,Combined intravenous immunoglobulin and methylprednisolone as induction treatment in chronic inflammatory demyelinating polyneuropathy (OPTIC protocol): a prospective pilot study.,"BACKGROUND AND PURPOSE


We hypothesized that combining intravenous immunoglobulin (IVIg) and intravenous methylprednisolone (IVMP) leads to more frequent remission compared with IVIg alone while maintaining the fast efficacy of IVIg. In this uncontrolled pilot study, we evaluated remission, rate of improvement and safety in patients with chronic inflammatory demyelinating polyradiculoneuropathy receiving induction treatment with combined IVIg and IVMP.
METHODS


Consecutive treatment-naive patients with chronic inflammatory demyelinating polyradiculoneuropathy were treated with IVIg infusions, consisting of a 2 g/kg loading dose and 1 g/kg maintenance treatment every 3 weeks, combined with 3-weekly 1-g IVMP infusions, for a total of 18 weeks. The cumulative steroid dose was 7 g. Primary outcome was remission at 1 year in patients who completed the treatment schedule. Remission was defined as improvement at 18 weeks without the need for further immune treatment between end of the treatment schedule and 1-year follow-up. Improvement was defined as a minimal clinically important difference on the Inflammatory Rasch-Built Overall Disability Scale and/or an increase of ≥8 kPa in grip strength between baseline and week 18.
RESULTS


A total of 20 patients were included; 17 completed the treatment schedule. A total of 13 (76%) of these patients improved at 18 weeks after start of treatment and 10 (59%) patients were in remission at 1 year. Serious adverse events were found in four patients.
CONCLUSIONS


Short-term combined induction treatment with IVIg and IVMP induced remission in almost 60% of patients who completed the treatment schedule. Combined induction therapy was generally well tolerated. A randomized controlled trial is currently running to confirm efficacy and safety of IVMP as add-on treatment to IVIg.",2020,"Serious adverse events were found in four patients.
","['Twenty patients were included; 17 completed the treatment schedule', 'CIDP patients receiving induction treatment with combined IVIg and IVMP', 'chronic inflammatory demyelinating polyneuropathy (OPTIC-protocol', 'Consecutive treatment-naïve CIDP patients']","['IVMP', 'immunoglobulin and methylprednisolone', 'intravenous immunoglobulin(IVIg) and intravenous methylprednisolone(IVMP', 'IVIg-infusions']","['tolerated', 'IVIg and IVMP induced remission', 'grip strength', 'Serious adverse events', 'Remission']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0393819', 'cui_str': 'Inflammatory Polyradiculopathy, Chronic'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0085297', 'cui_str': 'Immunoglobulins, Intravenous'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0270922', 'cui_str': 'Peripheral demyelinating neuropathy'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C0021027', 'cui_str': 'Immune Globulins'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0085297', 'cui_str': 'Immunoglobulins, Intravenous'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}]","[{'cui': 'C0085297', 'cui_str': 'Immunoglobulins, Intravenous'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0429271', 'cui_str': 'Grip strength (observable entity)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",17.0,0.0952924,"Serious adverse events were found in four patients.
","[{'ForeName': 'M E', 'Initials': 'ME', 'LastName': 'Adrichem', 'Affiliation': 'Department of Neurology, Amsterdam Neuroscience, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'S R', 'Initials': 'SR', 'LastName': 'Bus', 'Affiliation': 'Department of Neurology, Amsterdam Neuroscience, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Wieske', 'Affiliation': 'Department of Neurology, Amsterdam Neuroscience, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Mohammed', 'Affiliation': 'Department of Neurology, Maidstone Hospital, Maidstone, Kent, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Verhamme', 'Affiliation': 'Department of Neurology, Amsterdam Neuroscience, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Hadden', 'Affiliation': 'Department of Neurology, Maidstone Hospital, Maidstone, Kent, UK.'}, {'ForeName': 'I N', 'Initials': 'IN', 'LastName': 'van Schaik', 'Affiliation': 'Department of Neurology, Amsterdam Neuroscience, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Eftimov', 'Affiliation': 'Department of Neurology, Amsterdam Neuroscience, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}]",European journal of neurology,['10.1111/ene.14096']
3560,31241488,Individualization of Migraine Prevention: A Randomized Controlled Trial of Psychophysical-based Prediction of Duloxetine Efficacy.,"OBJECTIVE


Finding an effective preventive agent for the individual migraineur is often long and frustrating. An individual-specific, efficacy-predicting tool would be invaluable in directing, shortening, and improving this process. As the serotonin-norepinephrine reuptake inhibitor duloxetine is a pain modulator, we hypothesized that pronociceptivity will directly predict drug efficacy, so that the more pronociceptive the patient is, the more efficacious the drug. Therefore, we used psychophysical pain measures to predict duloxetine efficacy in migraine prevention.
METHODS


Fifty-five migraineurs participated: 27 received duloxetine and 28 nonactive placebo. Responses to painful stimuli, conditioned pain modulation, and temporal summation of pain were measured before treatment. Treatment outcome measures included changes in attack frequency, migraine days, pain levels, and a reported self-estimate of migraine improvement at weeks 4 and 5. To examine treatment effects, the outcome measures were compared with pretreatment levels. Treatment by the psychophysical-predictor effect on treatment outcome was examined in separate regression models.
RESULTS


Duloxetine was more efficacious than placebo in migraine prevention, as indicated by the patient's estimation of migraine improvement (duloxetine: 52.3±30.4%; placebo: 26.0±27.3%; P=0.001). Further, this measure, in the duloxetine group, was predicted by higher pretreatment pain ratings for tonic heat pain (P=0.012); greater pain sensitivity at baseline predicted greater percent of migraine improvement in duloxetine (r=0.47; P=0.013), but not in placebo (r=-0.36; P=0.060).
DISCUSSION


Our results suggest how personalized medicine can be applied to designing appropriate migraine prevention treatment. Psychophysical testing can reveal and characterize pronociceptive migraineurs, who seem to be more likely than non-pronociceptive ones to benefit from migraine prevention with serotonin-norepinephrine reuptake inhibitors.",2019,"RESULTS


Duloxetine was more efficacious than placebo in migraine prevention as indicated by the patient's estimation of migraine-improvement (duloxetine: 52.3±30.4%; placebo: 26.0±27.3%; P=0.001).",['Fifty-five migraineurs participated; 27 received'],"['placebo', 'Duloxetine', 'serotonin norepinephrine reuptake inhibitors (SNRI) duloxetine', 'duloxetine and 28 non-active placebo', 'duloxetine', 'Migraine Prevention']","['higher pre-treatment pain ratings for tonic heat pain', 'Responses to painful stimuli, conditioned pain modulation and temporal summation of pain', 'changes in attack-frequency, migraine-days, pain levels and a reported self-estimate of migraine-improvement', 'pain-sensitivity']","[{'cui': 'C0450382', 'cui_str': '55 (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0245561', 'cui_str': 'duloxetine'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C4521489', 'cui_str': 'Norepinephrine reuptake inhibitor (disposition)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C1291732', 'cui_str': 'Treatment pain'}, {'cui': 'C3543842', 'cui_str': 'TONICS'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0234402', 'cui_str': 'Stimulus, function (observable entity)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0234110', 'cui_str': 'Temporal summation, function (observable entity)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1304680', 'cui_str': 'Attack (finding)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}]",55.0,0.0831359,"RESULTS


Duloxetine was more efficacious than placebo in migraine prevention as indicated by the patient's estimation of migraine-improvement (duloxetine: 52.3±30.4%; placebo: 26.0±27.3%; P=0.001).","[{'ForeName': 'Lee B', 'Initials': 'LB', 'LastName': 'Kisler', 'Affiliation': 'Laboratory of Clinical Neurophysiology, Technion Faculty of Medicine.'}, {'ForeName': 'Irit', 'Initials': 'I', 'LastName': 'Weissman-Fogel', 'Affiliation': 'Faculty of Social Welfare and Health Sciences, University of Haifa, Haifa, Israel.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Coghill', 'Affiliation': ""Department of Anesthesiology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH.""}, {'ForeName': 'Elliot', 'Initials': 'E', 'LastName': 'Sprecher', 'Affiliation': 'Department of Neurology, Rambam Health Care Campus.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Yarnitsky', 'Affiliation': 'Laboratory of Clinical Neurophysiology, Technion Faculty of Medicine.'}, {'ForeName': 'Yelena', 'Initials': 'Y', 'LastName': 'Granovsky', 'Affiliation': 'Laboratory of Clinical Neurophysiology, Technion Faculty of Medicine.'}]",The Clinical journal of pain,['10.1097/AJP.0000000000000739']
3561,31831079,"FKB327, an adalimumab biosimilar, versus the reference product: results of a randomized, Phase III, double-blind study, and its open-label extension.","OBJECTIVE


To compare the efficacy, serum drug concentrations, immunogenicity, and safety of FKB327 with the adalimumab reference product (RP) in combination with methotrexate in patients with moderate-to-severe, active rheumatoid arthritis (RA).
METHODS


Patients were randomized 1:1 in a double-blind study (NCT02260791), received 40 mg of FKB327 or RP by subcutaneous injection every other week for 24 weeks (Period I), then re-randomized 2:1, remaining on the same study drug or switching to the other up to week 54 in an open-label extension (Period II, NCT02405780). Efficacy was evaluated using American College of Rheumatology (ACR20) response rate difference at week 24 with equivalence margins of ± 13% and - 12% to + 15% using 95% and 90% confidence intervals (CIs), respectively. Efficacy, serum drug concentrations, immunogenicity, and safety were compared at week 54.
RESULTS


A total of 730 patients were randomized in Period I (n = 367 FKB327, n = 363 RP), and 645 transitioned to Period II (n = 216 FKB327-FKB327, n = 108 FKB327-RP, n = 108 RP-FKB327, n = 213 RP-RP). At week 24, ACR20 response rates were 74.1% with FKB327 versus 75.7% with RP. 95% and 90% CI of the response rate difference were - 7.9 to 4.7% and - 7.3 to 3.6%, respectively, meeting predefined equivalence margins. The ACR20 response rate remained over 70% of patients to week 54 with all treatment sequences. In Period I, mean trough serum drug concentrations were slightly higher for patients receiving FKB327 than those receiving RP. Mean concentrations were stable over time and reflected steady state in Period II. The proportions of patients with samples positive for neutralizing antidrug antibodies (ADAs) were comparable (57.7% with FKB327 vs. 55.5% with RP) at week 24, and no consistent difference in ADA were seen between continuous and switched treatments in Period II. Efficacy was slightly reduced in the small proportion of patients with high ADA titers in all treatment groups. No clinically significant differences were observed in the incidence of commonly reported treatment-emergent adverse events between the treatments across Periods I and II.
CONCLUSION


FKB327 was equivalent to RP in clinical efficacy and demonstrated comparable safety and immunogenicity in patients with moderate-to-severe RA. No effect of switching between FKB327 and RP was observed.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT02260791, Registered 29 July 2014. ClinicalTrials.gov, NCT02405780, Registered 17 July 2015.",2019,"No clinically significant differences were observed in the incidence of commonly reported treatment-emergent adverse events between the treatments across Periods I and II.
","['patients with moderate-to-severe, active rheumatoid arthritis (RA', 'Patients', 'patients with moderate-to-severe RA', '730 patients']","['FKB327', 'FKB327 with the adalimumab reference product (RP) in combination with methotrexate', '40\u2009mg of FKB327 or RP']","['American College of Rheumatology (ACR20) response rate difference', 'mean trough serum drug concentrations', 'ACR20 response rate', 'ADA', 'ACR20 response rates', 'incidence of commonly reported treatment-emergent adverse events', 'efficacy, serum drug concentrations, immunogenicity, and safety', 'Efficacy', 'Mean concentrations', 'Efficacy, serum drug concentrations, immunogenicity, and safety', 'safety and immunogenicity', 'response rate difference', 'neutralizing antidrug antibodies (ADAs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}]","[{'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}]","[{'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0444506', 'cui_str': 'Trough (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}]",108.0,0.115706,"No clinically significant differences were observed in the incidence of commonly reported treatment-emergent adverse events between the treatments across Periods I and II.
","[{'ForeName': 'Mark C', 'Initials': 'MC', 'LastName': 'Genovese', 'Affiliation': 'Division of Immunology and Rheumatology, Stanford University, 1000 Welch Rd, #203, Palo Alto, CA, USA. genovese@stanford.edu.'}, {'ForeName': 'Josephine', 'Initials': 'J', 'LastName': 'Glover', 'Affiliation': 'Coephycient Pharmaceutical Consultancy, Guildford, UK.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Greenwald', 'Affiliation': 'Desert Medical Advances, Palm Desert, CA, USA.'}, {'ForeName': 'Wieslawa', 'Initials': 'W', 'LastName': 'Porawska', 'Affiliation': 'Centrum Badań Klinicznych S.C, Poznański Ośrodek Medyczny NOVAMED, Poznań, Poland.'}, {'ForeName': 'Elias Chalouhi', 'Initials': 'EC', 'LastName': 'El Khouri', 'Affiliation': 'Clínica Internacional, Lima, Peru.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Dokoupilova', 'Affiliation': 'MEDICAL PLUS s.r.o., Uherské Hradiště, Czech Republic; Faculty of Pharmacy, Department of Pharmaceutics, University of Veterinary and Pharmaceutical Sciences, Brno, Czech Republic.'}, {'ForeName': 'Juan Ignacio', 'Initials': 'JI', 'LastName': 'Vargas', 'Affiliation': 'Quantum Research, Puerto Varas, Chile.'}, {'ForeName': 'Mykola', 'Initials': 'M', 'LastName': 'Stanislavchuk', 'Affiliation': 'National Pirogov Memorial Medical University, Vinnytsia, Ukraine.'}, {'ForeName': 'Herbert', 'Initials': 'H', 'LastName': 'Kellner', 'Affiliation': 'Center for Rheumatology and Gastroenterology, Munich, Germany.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Baranova', 'Affiliation': 'First Saint-Petersburg State Medical University, St. Petersburg, Russia.'}, {'ForeName': 'Nobuhito', 'Initials': 'N', 'LastName': 'Matsunaga', 'Affiliation': 'Fujifilm Kyowa Kirin Biologics, Tokyo, Japan.'}, {'ForeName': 'Rieke', 'Initials': 'R', 'LastName': 'Alten', 'Affiliation': 'Schlosspark-Klinik, University Medicine Berlin, Berlin, Germany.'}]",Arthritis research & therapy,['10.1186/s13075-019-2046-0']
3562,32077301,Effects of Intervention Characteristics on Willingness to Initiate a Weight Gain Prevention Program.,"PURPOSE


To determine characteristics of weight gain prevention programs that facilitate engagement.
DESIGN


Randomized factorial experiment (5 × 2).
SETTING


Recruited nationally online.
PARTICIPANTS


Adults aged 18 to 75 with body mass index ≥25 who decline a behavioral weight loss intervention (n = 498).
MEASURES


Participants were randomly presented with one of 10 possible descriptions of hypothetical, free weight gain prevention programs that were all low dose and technology-based but differed in regard to 5 behavior change targets (self-weighing only; diet only; physical activity only; combined diet, physical activity, and self-weighing; or choice between diet, physical activity, and self-weighing targets) crossed with 2 financial incentive conditions (presence or absence of incentives for self-monitoring). Participants reported willingness to join the programs, perceived program effectiveness, and reasons for declining enrollment.
ANALYSIS


Logistic regression and linear regression to test effects of program characteristics offered on willingness to initiate programs and programs' perceived effectiveness, respectively. Content analyses for open-ended text responses.
RESULTS


Participants offered the self-weighing-only programs were more willing to initiate than those offered the programs targeting all 3 behaviors combined (50% vs 36%; odds ratio [OR] = 1.79; 95% confidence interval [CI], 1.01-3.13). Participants offered the programs with financial incentives were more willing to initiate (50% vs 33%; OR = 2.08; 95% CI, 1.44-2.99) and anticipated greater intervention effectiveness (β = .34,  P  = .02) than those offered no financial incentives. Reasons for declining to initiate included specific program features, behavior targets, social aspects, and benefits.
CONCLUSION


Targeting self-weighing and providing financial incentives for self-monitoring may result in greater uptake of weight gain prevention programs.
STUDY PREREGISTRATION


https://osf.io/b9zfh, June 19, 2018.",2020,"Participants offered the programs with financial incentives were more willing to initiate (50% vs 33%; OR = 2.08; 95% CI, 1.44-2.99) and anticipated greater intervention effectiveness (β = .34,  P  = .02) than those offered no financial incentives.","['Adults aged 18 to 75 with body mass index ≥25 who decline a behavioral weight loss intervention (n = 498', 'Participants were randomly presented with one of 10 possible descriptions of hypothetical, free weight gain prevention programs that were all low dose and technology-based but differed in regard to 5 behavior change targets (self-weighing only; diet only', 'Recruited nationally online', 'https://osf.io/b9zfh , June 19, 2018']","['physical activity only; combined diet, physical activity, and self-weighing; or choice between diet, physical activity, and self-weighing targets) crossed with 2 financial incentive conditions (presence or absence of incentives for self-monitoring']",['intervention effectiveness'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0332149', 'cui_str': 'Possible (qualifier value)'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C3854307', 'cui_str': 'Presence'}, {'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}, {'cui': 'C0588436', 'cui_str': 'Self-monitoring (regime/therapy)'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}]",,0.0528058,"Participants offered the programs with financial incentives were more willing to initiate (50% vs 33%; OR = 2.08; 95% CI, 1.44-2.99) and anticipated greater intervention effectiveness (β = .34,  P  = .02) than those offered no financial incentives.","[{'ForeName': 'Megan A', 'Initials': 'MA', 'LastName': 'McVay', 'Affiliation': 'Department of Health Education and Behavior, College of Health and Human Performance, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Marissa L', 'Initials': 'ML', 'LastName': 'Donahue', 'Affiliation': 'Department of Health Education and Behavior, College of Health and Human Performance, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'JeeWon', 'Initials': 'J', 'LastName': 'Cheong', 'Affiliation': 'Department of Health Education and Behavior, College of Health and Human Performance, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Bacon', 'Affiliation': 'Department of Health Education and Behavior, College of Health and Human Performance, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Perri', 'Affiliation': 'Department of Clinical and Health Psychology, College of Public Health and Health Professions, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Kathryn M', 'Initials': 'KM', 'LastName': 'Ross', 'Affiliation': 'Department of Clinical and Health Psychology, College of Public Health and Health Professions, University of Florida, Gainesville, FL, USA.'}]",American journal of health promotion : AJHP,['10.1177/0890117120905709']
3563,32071058,Assessment of Drug Resistance during Phase 2b Clinical Trials of Presatovir in Adults Naturally Infected with Respiratory Syncytial Virus.,"This study summarizes drug resistance analyses in 4 recent phase 2b trials of the respiratory syncytial virus (RSV) fusion inhibitor presatovir in naturally infected adults. Adult hematopoietic cell transplant (HCT) recipients, lung transplant recipients, or hospitalized patients with naturally acquired, laboratory-confirmed RSV infection were enrolled in 4 randomized, double-blind, placebo-controlled studies with study-specific presatovir dosing. Full-length RSV  F  sequences amplified from nasal swabs obtained at baseline and postbaseline were analyzed by population sequencing. Substitutions at RSV fusion inhibitor resistance-associated positions are reported. Genotypic analyses were performed on 233 presatovir-treated and 149 placebo-treated subjects. RSV F variant V127A was present in 8 subjects at baseline. Population sequencing detected treatment-emergent substitutions in 10/89 (11.2%) HCT recipients with upper and 6/29 (20.7%) with lower respiratory tract infection, 1/35 (2.9%) lung transplant recipients, and 1/80 (1.3%) hospitalized patients treated with presatovir; placebo-treated subjects had no emergent resistance-associated substitutions. Subjects with substitutions at resistance-associated positions had smaller decreases in viral load during treatment relative to those without, but they had similar clinical outcomes. Subject population type and dosing regimen may have influenced RSV resistance development during presatovir treatment. Subjects with genotypic resistance development had decreased virologic responses compared to those without genotypic resistance but had comparable clinical outcomes.",2020,"Subjects with substitutions at resistance-associated positions had smaller decreases in viral load during treatment relative to those without, but similar clinical outcomes.","['4 recent phase 2b trials of the respiratory syncytial virus (RSV) fusion inhibitor presatovir in naturally infected adults', 'adults naturally infected with respiratory syncytial virus', 'Adult hematopoietic cell transplant (HCT) recipients, lung transplant recipients, or hospitalized patients with naturally acquired, laboratory-confirmed RSV infection']","['placebo', 'presatovir; placebo']","['virologic responses', 'RSV resistance development', 'emergent resistance-associated substitutions', 'viral load']","[{'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0035236', 'cui_str': 'Respiratory syncytial virus'}, {'cui': 'C1275666', 'cui_str': 'Fusion inhibitor'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0206152', 'cui_str': 'Cell Transplants'}, {'cui': 'C0024128', 'cui_str': 'Grafting, Lung'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439661', 'cui_str': 'Acquired (qualifier value)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C3714514', 'cui_str': 'Infection'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205466', 'cui_str': 'virology'}, {'cui': 'C0035236', 'cui_str': 'Respiratory syncytial virus'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}]",233.0,0.226378,"Subjects with substitutions at resistance-associated positions had smaller decreases in viral load during treatment relative to those without, but similar clinical outcomes.","[{'ForeName': 'Danielle P', 'Initials': 'DP', 'LastName': 'Porter', 'Affiliation': 'Gilead Sciences, Inc., Foster City, California, USA Danielle.Porter@gilead.com.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Gilead Sciences, Inc., Foster City, California, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Perry', 'Affiliation': 'Gilead Sciences, Inc., Foster City, California, USA.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Gossage', 'Affiliation': 'Gilead Sciences, Inc., Foster City, California, USA.'}, {'ForeName': 'Timothy R', 'Initials': 'TR', 'LastName': 'Watkins', 'Affiliation': 'Gilead Sciences, Inc., Foster City, California, USA.'}, {'ForeName': 'Jason W', 'Initials': 'JW', 'LastName': 'Chien', 'Affiliation': 'Gilead Sciences, Inc., Foster City, California, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Jordan', 'Affiliation': 'Gilead Sciences, Inc., Foster City, California, USA.'}]",Antimicrobial agents and chemotherapy,['10.1128/AAC.02312-19']
3564,28671097,"Clinical observation on the therapeutic effect of desloratadine citrate disodium in the treatment of chronic urticaria and changes in IL4, IL18, IL23 and IL-33 levels before and after treatment.","The effect of citrate to Desloratadine Citrate Disodium set in the treatment of chronic urticaria in patients with IL4, IL18, and IL23, IL33 levels was investigated. 100 cases of chronic urticaria treated in our hospital from January 2013 to January 2015 were divided into study group and control group by random number table method. Patients in the study group with chloric thunder of citric acid treatment, the control group were treated with mizolastine in the treatment, the treatment time for 2 weeks. The difference of curative effect between the two groups and the changes of IL4, IL18, IL23, IL 33 before and after treatment in two groups were compared. After two weeks of treatment, the total effective rate of the study group was 94%, while the total effective rate of the control group was only 78%, which was statistically significant (P<0.05). Before treatment, the two groups of patients with IL4, IL18, IL23, IL33 levels were higher, and the difference between the groups was not statistically significant (P>0.05), after treatment, the two groups of patients with IL4, IL18, IL23, IL33 were decreased, but the study group patients decreased significantly, the data between the two groups was statistically significant (P<0.05).
CONCLUSION


Desloratadine citrate disodium treatment effect of chronic urticaria is better, and after treatment, IL4, IL18, IL23, IL33 levels decreased significantly.",2017,"Before treatment, the two groups of patients with IL4, IL18, IL23, IL33 levels were higher, and the difference between the groups was not statistically significant (P>0.05), after treatment, the two groups of patients with IL4, IL18, IL23, IL33 were decreased, but the study group patients decreased significantly, the data between the two groups was statistically significant (P<0.05).
","['chronic urticaria in patients with IL4, IL18, and IL23, IL33 levels was investigated', '100 cases of chronic urticaria treated in our hospital from January 2013 to January 2015']","['citric acid', 'desloratadine citrate disodium', 'Desloratadine citrate disodium', 'Desloratadine Citrate Disodium', 'mizolastine']","['IL4, IL18, IL23, IL33 levels', 'chronic urticaria', 'curative effect', 'chronic urticaria and changes in IL4, IL18, IL23 and IL-33 levels', 'total effective rate']","[{'cui': 'C0263338', 'cui_str': 'Chronic urticaria (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021758', 'cui_str': 'Interleukin-4'}, {'cui': 'C0383327', 'cui_str': 'Interferon-gamma-Inducing Factor'}, {'cui': 'C3540587', 'cui_str': 'IL33'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1292732', 'cui_str': 'Investigates'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C0055819', 'cui_str': 'Citric Acid'}, {'cui': 'C0252352', 'cui_str': 'desethoxycarbonyl-loratadine'}, {'cui': 'C0376259', 'cui_str': 'Citrate'}, {'cui': 'C0171302', 'cui_str': 'mizolastine'}]","[{'cui': 'C0021758', 'cui_str': 'Interleukin-4'}, {'cui': 'C0383327', 'cui_str': 'Interferon-gamma-Inducing Factor'}, {'cui': 'C3540587', 'cui_str': 'IL33'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0263338', 'cui_str': 'Chronic urticaria (disorder)'}, {'cui': 'C1276305', 'cui_str': 'Curative procedure'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}]",,0.0123256,"Before treatment, the two groups of patients with IL4, IL18, IL23, IL33 levels were higher, and the difference between the groups was not statistically significant (P>0.05), after treatment, the two groups of patients with IL4, IL18, IL23, IL33 were decreased, but the study group patients decreased significantly, the data between the two groups was statistically significant (P<0.05).
","[{'ForeName': 'Dinghui', 'Initials': 'D', 'LastName': 'Zheng', 'Affiliation': 'Department of Dermatology, Guangzhou Red Cross Hospital, Medical College, Jinan University, Guangzhou, China.'}, {'ForeName': 'Xian', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Department of Dermatology, Guangzhou Red Cross Hospital, Medical College, Jinan University, Guangzhou, China.'}]",Pakistan journal of pharmaceutical sciences,[]
3565,31727194,The glycation level of milk protein strongly modulates post-prandial lysine availability in humans.,"Industrial heat treatment of milk results in protein glycation. A high protein glycation level has been suggested to compromise the post-prandial rise in plasma amino acid availability following protein ingestion. In the present study, we assessed the impact of glycation level of milk protein on post-prandial plasma amino acid responses in humans. Fifteen healthy, young men (age 26 (SEM 1) years, BMI 24 (SEM 1) kg/m2) participated in this randomised cross-over study and ingested milk protein powder with protein glycation levels of 3, 20 and 50 % blocked lysine. On each trial day, arterialised blood samples were collected at regular intervals during a 6-h post-prandial period to assess plasma amino acid concentrations using ultra-performance liquid chromatography. Plasma essential amino acid (EAA) concentrations increased following milk protein ingestion, with the 20 and 50 % glycated milk proteins showing lower overall EAA responses compared with the 3 % glycated milk protein (161 (SEM 7) and 142 (SEM 7) v. 178 (SEM 9) mmol/l × 6 h, respectively; P ≤ 0·011). The lower post-prandial plasma amino acid responses were fully attributed to an attenuated post-prandial rise in circulating plasma lysine concentrations. Plasma lysine responses (incremental AUC) following ingestion of the 20 and 50 % glycated milk proteins were 35 (SEM 4) and 92 (SEM 2) % lower compared with the 3 % glycated milk protein (21·3 (SEM 1·4) and 2·8 (SEM 0·7) v. 33·3 (SEM 1·7) mmol/l × 6 h, respectively; P < 0·001). Milk protein glycation lowers post-prandial plasma lysine availability in humans. The lower post-prandial availability of lysine following ingestion of proteins with a high glycation level may compromise the anabolic properties of a protein source.",2020,"Plasma essential amino acid concentrations increased following milk protein ingestion, with the 20% and 50% glycated milk proteins showing lower overall essential amino acid responses compared to the 3% glycated milk protein (161±7 and 142±7 vs 178±9 mmol·L-1·6 h-1, respectively; P≤0.011).","['Fifteen healthy, young men (age: 26±1 y, BMI: 24±1 kg·m-2', 'humans']",['Milk protein glycation'],"['overall essential amino acid responses', 'Plasma essential amino acid concentrations', 'glycated milk protein', 'glycated milk proteins', 'Plasma lysine responses (iAUC']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0026138', 'cui_str': 'Milk Proteins'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0002525', 'cui_str': 'Amino Acids, Essential'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C3666909', 'cui_str': 'Glycate'}, {'cui': 'C0026138', 'cui_str': 'Milk Proteins'}, {'cui': 'C0024337', 'cui_str': 'L-lysine'}]",15.0,0.0243405,"Plasma essential amino acid concentrations increased following milk protein ingestion, with the 20% and 50% glycated milk proteins showing lower overall essential amino acid responses compared to the 3% glycated milk protein (161±7 and 142±7 vs 178±9 mmol·L-1·6 h-1, respectively; P≤0.011).","[{'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Nyakayiru', 'Affiliation': 'Department of Human Biology, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre+, 6229 ERMaastricht, the Netherlands.'}, {'ForeName': 'Glenn A A', 'Initials': 'GAA', 'LastName': 'van Lieshout', 'Affiliation': 'FrieslandCampina, 3818 LEAmersfoort, the Netherlands.'}, {'ForeName': 'Jorn', 'Initials': 'J', 'LastName': 'Trommelen', 'Affiliation': 'Department of Human Biology, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre+, 6229 ERMaastricht, the Netherlands.'}, {'ForeName': 'Janneau', 'Initials': 'J', 'LastName': 'van Kranenburg', 'Affiliation': 'Department of Human Biology, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre+, 6229 ERMaastricht, the Netherlands.'}, {'ForeName': 'Lex B', 'Initials': 'LB', 'LastName': 'Verdijk', 'Affiliation': 'Department of Human Biology, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre+, 6229 ERMaastricht, the Netherlands.'}, {'ForeName': 'Marjolijn C E', 'Initials': 'MCE', 'LastName': 'Bragt', 'Affiliation': 'FrieslandCampina, 3818 LEAmersfoort, the Netherlands.'}, {'ForeName': 'Luc J C', 'Initials': 'LJC', 'LastName': 'van Loon', 'Affiliation': 'Department of Human Biology, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre+, 6229 ERMaastricht, the Netherlands.'}]",The British journal of nutrition,['10.1017/S0007114519002927']
3566,31373696,Response to Glucocorticosteroids Predicts Olfactory Outcome After ESS in Chronic Rhinosinusitis.,"OBJECTIVES


Olfaction is frequently impaired in chronic rhinosinusitis with nasal polyps (CRSwNP) and often improves after endoscopic sinus surgery (ESS). Data about dynamics of olfactory changes after ESS are lacking, and little information is available concerning whether preoperatively administered glucocorticosteroids predict postoperative olfaction. Therefore, the aim of this study was to examine dynamics of olfaction after ESS in relation to the effect of preoperative administration of glucocorticosteroids in CRSwNP.
METHODS


This prospective study included 52 CRSwNP patients (30 men, 22 women, mean age 54 ± 14 years) divided into a control group (n = 31) subjected to ESS without preoperative steroids and a treatment group (n = 21) receiving orally administered glucocorticosteroids preoperatively. Self-ratings of olfaction and olfactory testing using the extended Sniffin' Sticks test battery (threshold, discrimination and identification [TDI] score) were performed. Olfaction was measured preoperatively; after termination of glucocorticosteroid treatment (only treatment group); and 2 weeks, 1 month, and 3 months postoperatively.
RESULTS


After glucocorticosteroids, TDI score significantly improved in 57% of patients, and olfactory function remained unchanged in 43%. In addition, improvement in TDI score after steroids and 3 months postoperatively were significantly correlated (r = 0.66, P = 0.01). Patients whose olfaction did not improve after glucocorticosteroids did not benefit from surgery. Regarding postoperative olfactory dynamics, TDI score reached its maximum 1 month postoperatively and decreased again approximately 3 months after surgery.
CONCLUSION


Glucocorticosteroids improved olfaction in CRSwNP comparable to surgery. In addition, changes in relation to steroids predicted olfactory outcome postoperatively. Regarding the olfactory dynamics, it could be demonstrated that olfactory function increased 1 month after surgery and decreased 3 months postoperatively.
LEVEL OF EVIDENCE


2 Laryngoscope, 130:1616-1621, 2020.",2020,"After glucocorticosteroids, TDI score significantly improved in 57% of patients, and olfactory function remained unchanged in 43%.","['52 CRSwNP patients (30 men, 22 women, mean age 54\u2009±\u200914\u2009years) divided into a control group (n = 31) subjected to', 'Chronic Rhinosinusitis', 'chronic rhinosinusitis with nasal polyps (CRSwNP']","['ESS without preoperative steroids and a treatment group (n = 21) receiving orally administered glucocorticosteroids preoperatively', 'Glucocorticosteroids', 'glucocorticosteroids', 'endoscopic sinus surgery (ESS']","[""extended Sniffin' Sticks test battery (threshold, discrimination and identification [TDI] score"", 'olfactory function', 'TDI score', 'Olfactory Outcome', 'Olfaction']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0149516', 'cui_str': 'Chronic sinusitis (disorder)'}, {'cui': 'C4524092', 'cui_str': 'Chronic rhinosinusitis with nasal polyps'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C4318418', 'cui_str': 'Stick'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0542351', 'cui_str': 'Battery (event)'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0012632', 'cui_str': 'Discrimination'}, {'cui': 'C0020792', 'cui_str': 'Identification'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439826', 'cui_str': 'Olfactory (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0037361', 'cui_str': 'Sense of Smell'}]",22.0,0.0370891,"After glucocorticosteroids, TDI score significantly improved in 57% of patients, and olfactory function remained unchanged in 43%.","[{'ForeName': 'Vasyl', 'Initials': 'V', 'LastName': 'Bogdanov', 'Affiliation': 'Smell & Taste Clinic, Department of Otorhinolaryngology, Technische Universität Dresden, Dresden.'}, {'ForeName': 'Ute', 'Initials': 'U', 'LastName': 'Walliczek-Dworschak', 'Affiliation': 'Smell & Taste Clinic, Department of Otorhinolaryngology, Technische Universität Dresden, Dresden.'}, {'ForeName': 'Katherine L', 'Initials': 'KL', 'LastName': 'Whitcroft', 'Affiliation': 'Smell & Taste Clinic, Department of Otorhinolaryngology, Technische Universität Dresden, Dresden.'}, {'ForeName': 'Basile N', 'Initials': 'BN', 'LastName': 'Landis', 'Affiliation': 'Smell & Taste Clinic, Department of Otorhinolaryngology, Technische Universität Dresden, Dresden.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hummel', 'Affiliation': 'Smell & Taste Clinic, Department of Otorhinolaryngology, Technische Universität Dresden, Dresden.'}]",The Laryngoscope,['10.1002/lary.28233']
3567,32071431,Early treatment with FCR versus watch and wait in patients with stage Binet A high-risk chronic lymphocytic leukemia (CLL): a randomized phase 3 trial.,"We report a randomized prospective phase 3 study (CLL7), designed to evaluate the efficacy of fludarabine, cyclophosphamide, and rituximab (FCR) in patients with an early-stage high-risk chronic lymphocytic leukemia (CLL). Eight hundred patients with untreated-stage Binet A disease were enrolled as intent-to-treat population and assessed for four prognostic markers: lymphocyte doubling time <12 months, serum thymidine kinase >10 U/L, unmutated IGHV genes, and unfavorable cytogenetics (del(11q)/del(17p)/trisomy 12). Two hundred and one patients with ≥2 risk features were classified as high-risk CLL and 1:1 randomized to receive either immediate therapy with 6xFCR (Hi-FCR, 100 patients), or to be observed according to standard of care (Hi-W&W, 101 patients). The overall response rate after early FCR was 92.7%. Common adverse events were hematological toxicities and infections (61.0%/41.5% of patients, respectively). After median observation time of 55.6 (0-99.2) months, event-free survival was significantly prolonged in Hi-FCR compared with Hi-W&W patients (median not reached vs. 18.5 months, p < 0.001). There was no significant overall survival benefit for high-risk patients receiving early FCR therapy (5-year OS 82.9% in Hi-FCR vs. 79.9% in Hi-W&W, p = 0.864). In conclusion, although FCR is efficient to induce remissions in the Binet A high-risk CLL, our data do not provide evidence that alters the current standard of care ""watch and wait"" for these patients.",2020,"There was no significant overall survival benefit for high-risk patients receiving early FCR therapy (5-year OS 82.9% in Hi-FCR vs. 79.9% in Hi-W&W, p = 0.864).","['Two hundred and one patients with ≥2 risk features were classified as high-risk CLL', 'patients with stage Binet A high-risk chronic lymphocytic leukemia (CLL', 'Eight hundred patients with untreated-stage Binet A disease were enrolled as intent-to-treat population and assessed for four prognostic markers: lymphocyte doubling time <12 months, serum thymidine kinase >10\u2009U/L, unmutated IGHV genes, and unfavorable cytogenetics (del(11q)/del(17p)/trisomy 12', 'patients with an early-stage high-risk chronic lymphocytic leukemia (CLL']","['immediate therapy with 6xFCR', 'fludarabine, cyclophosphamide, and rituximab (FCR', 'FCR']","['hematological toxicities and infections', 'overall survival benefit', 'overall response rate', 'event-free survival']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0023434', 'cui_str': 'Lymphoma, Small Lymphocytic'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C4018897', 'cui_str': 'Lymphocyte component of blood'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0040078', 'cui_str': 'Deoxythymidine Kinase'}, {'cui': 'C0439339', 'cui_str': 'mU/mL'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C0010802', 'cui_str': 'Cytogenetic'}, {'cui': 'C0432408', 'cui_str': 'Trisomy 12 (disorder)'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0059985', 'cui_str': 'fludarabine'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}]","[{'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}]",800.0,0.142644,"There was no significant overall survival benefit for high-risk patients receiving early FCR therapy (5-year OS 82.9% in Hi-FCR vs. 79.9% in Hi-W&W, p = 0.864).","[{'ForeName': 'Carmen D', 'Initials': 'CD', 'LastName': 'Herling', 'Affiliation': 'Department I of Internal Medicine and Center of Integrated Oncology Aachen Bonn Cologne Duesseldorf, University of Cologne, Cologne, Germany. carmen.herling@uk-koeln.de.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Cymbalista', 'Affiliation': ""Hopital Avicenne, Assistance Publique-Hopitaux de Paris (AP-HP), Service d'Hematologie Biologique, Bobigny, France.""}, {'ForeName': 'Carolin', 'Initials': 'C', 'LastName': 'Groß-Ophoff-Müller', 'Affiliation': 'Department I of Internal Medicine and Center of Integrated Oncology Aachen Bonn Cologne Duesseldorf, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Jasmin', 'Initials': 'J', 'LastName': 'Bahlo', 'Affiliation': 'Department I of Internal Medicine and Center of Integrated Oncology Aachen Bonn Cologne Duesseldorf, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Robrecht', 'Affiliation': 'Department I of Internal Medicine and Center of Integrated Oncology Aachen Bonn Cologne Duesseldorf, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Langerbeins', 'Affiliation': 'Department I of Internal Medicine and Center of Integrated Oncology Aachen Bonn Cologne Duesseldorf, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Anna-Maria', 'Initials': 'AM', 'LastName': 'Fink', 'Affiliation': 'Department I of Internal Medicine and Center of Integrated Oncology Aachen Bonn Cologne Duesseldorf, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Othman', 'Initials': 'O', 'LastName': 'Al-Sawaf', 'Affiliation': 'Department I of Internal Medicine and Center of Integrated Oncology Aachen Bonn Cologne Duesseldorf, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Raymonde', 'Initials': 'R', 'LastName': 'Busch', 'Affiliation': 'Institute for Medical Statistics and Epidemiology, Technical University, Munich, Germany.'}, {'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Porcher', 'Affiliation': 'Center of Clinical Epidemiology, Hopital Hotel-Dieu, Paris, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Cazin', 'Affiliation': 'Service de Maladies du Sang, CHU Claude Huriez, Lille Cedex, France.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Dreyfus', 'Affiliation': ""Service d'Hematologie, CHU Poitiers, Poitiers, France.""}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Ibach', 'Affiliation': 'WiSP Wissenschaftlicher Service Pharma GmbH, Langenfeld, Germany.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Leprêtre', 'Affiliation': 'Inserm Unit U1245 and Department of Hematology, Cancer Centre Henri Becquerel and Normandie University Rouen, Rouen, France.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Fischer', 'Affiliation': 'Department I of Internal Medicine and Center of Integrated Oncology Aachen Bonn Cologne Duesseldorf, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Kaiser', 'Affiliation': 'Day Clinic Hematology Oncology Palliative Care, Landshut, Germany.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Eichhorst', 'Affiliation': 'Department I of Internal Medicine and Center of Integrated Oncology Aachen Bonn Cologne Duesseldorf, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Clemens-Martin', 'Initials': 'CM', 'LastName': 'Wentner', 'Affiliation': 'Department of Hematology Oncology, Immunology, Palliative Medicine, Infectious Diseases and Tropical Medicine, Klinikum Schwabing, Munich, Germany.'}, {'ForeName': 'Manuela A', 'Initials': 'MA', 'LastName': 'Hoechstetter', 'Affiliation': 'Department of Hematology Oncology, Immunology, Palliative Medicine, Infectious Diseases and Tropical Medicine, Klinikum Schwabing, Munich, Germany.'}, {'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Döhner', 'Affiliation': 'Department of Internal Medicine III, University of Ulm, Ulm, Germany.'}, {'ForeName': 'Veronique', 'Initials': 'V', 'LastName': 'Leblond', 'Affiliation': 'Department of Haematology, Hopital de la Pitie-Salpetriere, Paris, France.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kneba', 'Affiliation': 'Second Department of Medicine, University of Schleswig-Holstein, Kiel, Germany.'}, {'ForeName': 'Remi', 'Initials': 'R', 'LastName': 'Letestu', 'Affiliation': ""Hopital Avicenne, Assistance Publique-Hopitaux de Paris (AP-HP), Service d'Hematologie Biologique, Bobigny, France.""}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Böttcher', 'Affiliation': 'Second Department of Medicine, University of Schleswig-Holstein, Kiel, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Stilgenbauer', 'Affiliation': 'Department of Internal Medicine III, University of Ulm, Ulm, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hallek', 'Affiliation': 'Department I of Internal Medicine and Center of Integrated Oncology Aachen Bonn Cologne Duesseldorf, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Levy', 'Affiliation': 'Unite de Recherche Clinique, Hopital Avicenne, Bobigny, France.'}]",Leukemia,['10.1038/s41375-020-0747-7']
3568,32035222,"The effects of concurrent training order on body composition and serum concentrations of follistatin, myostatin and GDF11 in sarcopenic elderly men.","BACKGROUND


Due to the important role of follistatin (FLST), myostatin (MSTN) and growth differentiation factor 11 (GDF11) in muscle mass regulation; alterations in the FLST to MSTN ratio (F:M) may result in muscle mass changes in response to different concurrent training (CT) order. This study investigated the influence of 8 weeks of CT order on body composition and serum concentrations of FLST, MSTN, their ratio (F:M) and GDF11 in sarcopenic elderly men.
METHODS


Thirty sarcopenic elderly men (age = 64.3 ± 3.5 years) were randomly assigned into one of three groups, endurance followed by resistance training (E + R; n = 10), resistance followed by endurance training (R + E; n = 10) or control (C; n = 10). Serum concentrations of muscle regulatory markers, body composition, maximum rate of oxygen consumption (VO 2max ), and upper and lower body strength were evaluated at baseline and after 8 weeks. The training protocol consisted of three training sessions per week for eight weeks.
RESULTS


There were significant group-by-time interactions (P < 0.05) for FLST, MSTN, GDF11 and F:M ratio. FLST (E + R = 187 pg/mL and R + E = 292 pg/mL) and F:M ratio (E + R = 0.20 and R + E = 0.27) significantly increased (P < 0.05) while MSTN (E + R = -308 pg/mL and R + E = -294 pg/mL) and GDF11 (E + R = -12 pg/mL and R + E = -10 pg/mL) significantly decreased (P < 0.05) following eight weeks in the E + R and R + E compared to no changes in the C group. In addition, there were significant group x time interactions (P < 0.01) for weight, BMI, body fat percentage (BFP), skeletal muscle mass (SMM), VO 2max , upper body strength, and lower body strength. BFP (E + R = -1.5% and R + E = -2%) significantly decreased (P < 0.01) while weight (E + R = 2.4 kg and R + E = 1.1 kg), BMI (E + R = 0.8 kg/m 2  and R + E = 0.3 kg/m 2 ), SMM (E + R = 0.7 kg and R + E = 0.5 kg), VO 2max  (E + R = 2.0 mL/kg/min and R + E = 1.8 mL/kg/min), upper body strength (E + R = 6.9 kg and R + E = 2.3 kg), and lower body strength (E + R = 9.8 kg and R + E = 4.4 kg) significantly increased (P < 0.01) in the E + R and R + E compared to no changes in the C group.
CONCLUSIONS


CT increases the F:M ratio and FLST as well as reducing MSTN and GDF11 in sarcopenic elderly men. Additionally, CT improved weight, body composition, muscle mass, function, and aerobic fitness. Notably, these results after CT were achieved irrespective of endurance and resistance exercise order in this population.",2020,"There were significant group-by-time interactions (P < 0.05) for FLST, MSTN, GDF11 and F:M ratio.","['sarcopenic elderly men', 'Thirty sarcopenic elderly men (age\u202f=\u202f64.3\u202f±\u202f3.5\u202fyears']","['FLST (E\u202f+\u202fR\u202f=\u202f187', 'CT', 'endurance followed by resistance training (E\u202f+\u202fR; n\u202f=\u202f10), resistance followed by endurance training (R\u202f+\u202fE; n\u202f=\u202f10) or control']","['body composition and serum concentrations of follistatin, myostatin and GDF11', 'Serum concentrations of muscle regulatory markers, body composition, maximum rate of oxygen consumption (VO 2max ), and upper and lower body strength', 'lower body strength', 'BFP', 'upper body strength', 'weight, BMI, body fat percentage (BFP), skeletal muscle mass (SMM), VO 2max , upper body strength, and lower body strength', 'CT improved weight, body composition, muscle mass, function, and aerobic fitness', 'body composition and serum concentrations of FLST, MSTN, their ratio (F:M) and GDF11']","[{'cui': 'C0524337', 'cui_str': 'Elderly man (person)'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C4517618', 'cui_str': '187 (qualifier value)'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0060623', 'cui_str': 'Activin-Binding Protein'}, {'cui': 'C1457899', 'cui_str': 'GDF-8'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C1268088', 'cui_str': 'Lower body'}, {'cui': 'C0045933', 'cui_str': 'BFP'}, {'cui': 'C1268087', 'cui_str': 'Upper body'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C0242692', 'cui_str': 'Muscle, Voluntary'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle (finding)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}]",30.0,0.0211093,"There were significant group-by-time interactions (P < 0.05) for FLST, MSTN, GDF11 and F:M ratio.","[{'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Bagheri', 'Affiliation': 'Department of Exercise Physiology, University of Isfahan, Isfahan, Iran.'}, {'ForeName': 'Babak Hooshmand', 'Initials': 'BH', 'LastName': 'Moghadam', 'Affiliation': 'Department of Exercise Physiology, Ferdowsi university of Mashhad, Mashhad, Iran.'}, {'ForeName': 'David D', 'Initials': 'DD', 'LastName': 'Church', 'Affiliation': 'Department of Geriatrics, Donald W. Reynolds Institute on Aging, Center for Translational Research in Aging & Longevity, University of Arkansas for Medical Sciences, Little Rock, AR, USA.'}, {'ForeName': 'Grant M', 'Initials': 'GM', 'LastName': 'Tinsley', 'Affiliation': 'Department of Kinesiology & Sport Management, Texas Tech University, Lubbock, TX 79424, USA.'}, {'ForeName': 'Mozhgan', 'Initials': 'M', 'LastName': 'Eskandari', 'Affiliation': 'Department of Exercise Physiology, University of Birjand, Birjand, Iran.'}, {'ForeName': 'Bizhan Hooshmand', 'Initials': 'BH', 'LastName': 'Moghadam', 'Affiliation': 'Department of Exercise Physiology, University of Birjand, Birjand, Iran.'}, {'ForeName': 'Mohammad S', 'Initials': 'MS', 'LastName': 'Motevalli', 'Affiliation': 'Department of Exercise Physiology, Ferdowsi university of Mashhad, Mashhad, Iran.'}, {'ForeName': 'Julien S', 'Initials': 'JS', 'LastName': 'Baker', 'Affiliation': 'Centre for Health and Exercise Science Research, Department of Sport, Physical Education and Health, Hong Kong Baptist University, Kowloon Tong, Hong Kong.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Robergs', 'Affiliation': 'School of Exercise and Nutrition Sciences, Queensland University of Technology, Kelvin Grove, Queensland, Australia.'}, {'ForeName': 'Alexei', 'Initials': 'A', 'LastName': 'Wong', 'Affiliation': 'Department of Health and Human Performance, Marymount University, Arlington, United States. Electronic address: awong@marymount.edu.'}]",Experimental gerontology,['10.1016/j.exger.2020.110869']
3569,31265147,Development of a group structured education programme to support safe exercise in people with Type 1 diabetes: the EXTOD education programme.,"AIM


To develop a structured education programme for individuals with Type 1 diabetes who are engaging in regular exercise.
METHOD


A multidisciplinary team of experts in supporting exercise and physical activity for people with Type 1 diabetes, alongside researchers with experience of developing self-management education, developed an exercise programme using the Medical Research Council framework. The programme was informed by a review of the evidence relating to Type 1 diabetes and exercise, the behaviour change literature (including the behaviour change taxonomy), and qualitative interviews with stakeholders. The programme and supporting resources were refined using an iterative process of testing, delivery and collecting feedback from participants and the wider development team.
RESULTS


The outcome of the intervention development was the design of a feasible and acceptable intervention for people with Type 1 diabetes to support safe exercise. The pilot allowed refinement of the intervention prior to testing in a two-site feasibility randomized controlled trial. Key findings from the pilot informed minor restructuring of the timetable (timings and order) and adaptation of supporting educational materials (participant handbook and teaching materials).
CONCLUSION


The 'EXercise in people with Type One Diabetes' (EXTOD) education programme has been developed using robust methodology for the generation of educational interventions. It now needs testing in a randomized controlled trial.",2020,"The programme and supporting resources were refined using an iterative process of testing, delivery and collecting feedback from participants and the wider development team.
","['individuals with Type 1 diabetes who are engaging in regular exercise', ""people with Type One Diabetes' (EXTOD) education programme"", 'people with Type 1 diabetes']","['structured education programme', 'education programme to support safe exercise']",[],"[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0582191', 'cui_str': 'Regular exercise (observable entity)'}, {'cui': 'C0729314', 'cui_str': 'Education provision (procedure)'}]","[{'cui': 'C0729314', 'cui_str': 'Education provision (procedure)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",[],,0.0758452,"The programme and supporting resources were refined using an iterative process of testing, delivery and collecting feedback from participants and the wider development team.
","[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Narendran', 'Affiliation': 'Department of Diabetes, University Hospitals Birmingham NHS Foundation Trust, Birmingham.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Greenfield', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Troughton', 'Affiliation': 'Leicester Diabetes Centre, University Hospitals Leicester, Leicester.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Doherty', 'Affiliation': 'Department of Psychological Medicine, York Teaching Hospitals NHS Foundation Trust, York.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Quann', 'Affiliation': 'Leicester Clinical Trials Unit, College of Life Sciences, University of Leicester, Leicester.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Thompson', 'Affiliation': 'Department of Diabetes, Taunton and Somerset NHS Foundation Trust, Taunton.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Litchfield', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham.'}, {'ForeName': 'R C', 'Initials': 'RC', 'LastName': 'Andrews', 'Affiliation': 'Department of Diabetes, Taunton and Somerset NHS Foundation Trust, Taunton.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetic medicine : a journal of the British Diabetic Association,['10.1111/dme.14064']
3570,32061002,"Low-Dose, Contrast-Enhanced Mammography Compared to Contrast-Enhanced Breast MRI: A Feasibility Study.","Contrast-enhanced MRI (CE-MRI) is the most sensitive technique for breast cancer detection. Contrast-enhanced mammography (CEM) is emerging as a possible alternative to CE-MRI.
PURPOSE


To evaluate the diagnostic performance of a low radiation dose contrast-enhanced mammography (L-CEM) in women with suspicious findings on conventional imaging compared to CE-MRI of the breast.
STUDY TYPE


Prospective, single center.
POPULATION


Women with suspicious findings on mammography, tomosynthesis, or ultrasound, and no contraindications for L-CEM or CE-MRI. Eighty women were included.
FIELD STRENGTH/SEQUENCE


1.5 and 3T CE-MRI, standard protocol for breast, with dedicated coils, according to international guidelines. L-CEM was performed using a dedicated prototype.
ASSESSMENT


Three, off-site, blinded readers evaluated the images according to the BI-RADS lexicon in a randomized order, each in two separate reading sessions. Histology served as a gold standard.
STATISTICAL TEST


Lesion detection rate, sensitivity, specificity, and negative and positive predictive values (NPV, PPV) were calculated and compared with multivariate statistics.
RESULTS


Included were 80 women (mean age, 54.3 years ±11.2 standard deviation) with 93 lesions (32 benign, 61 malignant). The detection rate was significantly higher with CE-MRI (92.5-94.6%; L-CEM 79.6-91.4%, P = 0.014). Sensitivity (L-CEM 65.6-90.2%; CE-MRI 83.6-93.4%, P = 0.086) and NPV (L-CEM 59.6-71.4%; CE-MRI 63.0-76.5%, P = 0.780) did not differ between the modalities. Specificity (L-CEM 46.9-96.9%; CE-MRI 37.5-53.1%, P = 0.001) and PPV (L-CEM 76.4-97.6%; CE-MRI 73.3-77.3%, P = 0.007) were significantly higher with L-CEM. Variations between readers were significant for sensitivity and NPV. The accuracy of L-CEM was as good as CE-MRI (75.3-76.3% vs. 72.0-75.3%, P = 0.514).
DATA CONCLUSION


L-CEM showed a high sensitivity and accuracy in women with suspicious findings on conventional imaging. Compared to CE-MRI, L-CEM has the potential to increase specificity and PPV. L-CEM might help to reduce false-positive biopsies while obtaining sensitivity comparable to that of CE-MRI LEVEL OF EVIDENCE: 1 TECHNICAL EFFICACY STAGE: 2 J. Magn. Reson. Imaging 2020;52:589-595.",2020,"The detection rate was significantly higher with CE-MRI (92.5-94.6%; L-CEM 79.6-91.4%, P = 0.014).","['Women with suspicious findings on mammography, tomosynthesis, or ultrasound, and no contraindications for L-CEM or CE-MRI', 'women with suspicious findings on conventional imaging compared to CE-MRI of the breast', '80 women (mean age, 54.3\u2009years ±11.2 standard deviation) with 93 lesions (32 benign, 61 malignant', 'Eighty women were included']","['L-CEM', 'low radiation dose contrast-enhanced mammography (L-CEM', 'Contrast-enhanced mammography (CEM', 'Low-Dose, Contrast-Enhanced Mammography', 'Contrast-enhanced MRI (CE-MRI']","['accuracy of L-CEM', 'sensitivity and accuracy', 'detection rate', 'PPV', 'diagnostic performance', 'sensitivity and NPV', 'Specificity', 'Sensitivity', 'Lesion detection rate, sensitivity, specificity, and negative and positive predictive values (NPV, PPV']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2607943', 'cui_str': 'findings'}, {'cui': 'C0024671', 'cui_str': 'Mammography'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C1301624', 'cui_str': 'Contraindications'}, {'cui': 'C0378574', 'cui_str': 'CEMS'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0205183', 'cui_str': 'Benign (qualifier value)'}, {'cui': 'C0205282', 'cui_str': 'Malignant (qualifier value)'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0378574', 'cui_str': 'CEMS'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0024671', 'cui_str': 'Mammography'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}]","[{'cui': 'C0378574', 'cui_str': 'CEMS'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",80.0,0.0348892,"The detection rate was significantly higher with CE-MRI (92.5-94.6%; L-CEM 79.6-91.4%, P = 0.014).","[{'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Clauser', 'Affiliation': 'Department of Biomedical Imaging and Image-Guided Therapy, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Pascal A T', 'Initials': 'PAT', 'LastName': 'Baltzer', 'Affiliation': 'Department of Biomedical Imaging and Image-Guided Therapy, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Panagiotis', 'Initials': 'P', 'LastName': 'Kapetas', 'Affiliation': 'Department of Biomedical Imaging and Image-Guided Therapy, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Hoernig', 'Affiliation': 'Diagnostic Imaging, Siemens Healthcare GmbH, Forchheim, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Weber', 'Affiliation': 'Department of Biomedical Imaging and Image-Guided Therapy, Division of General and Pediatric Radiology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Leone', 'Affiliation': 'ASST Fatebenefratelli-Sacco, Ospedale Fatebenefrateli e Oftalmico, Milan, Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Bernathova', 'Affiliation': 'Department of Biomedical Imaging and Image-Guided Therapy, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Thomas H', 'Initials': 'TH', 'LastName': 'Helbich', 'Affiliation': 'Department of Biomedical Imaging and Image-Guided Therapy, Medical University of Vienna, Vienna, Austria.'}]",Journal of magnetic resonance imaging : JMRI,['10.1002/jmri.27079']
3571,31825026,Does Applying Fluoride Varnish Every Three Months Better Prevent Caries Lesions in Erupting First Permanent Molars? A Randomised Clinical Trial.,"PURPOSE


To determine the effectiveness of fluoride varnish (FV) in preventing caries lesions on the erupting first permanent molars (FPM) of high-risk children.
MATERIALS AND METHODS


A randomised parallel-blinded clinical trial was conducted with a sample of 180 children between 6 and 7 years of age with at least one sound erupting FPM attending a public school in the Dominican Republic. Children were randomly assigned to three groups, one control and two experimental groups, which received FV application every 3 or 6 months. All the children received fluoride toothpaste (1450 ppm), toothbrush, diet counseling, and oral health recommendations every three months. The development of caries lesions was assessed at twelve months using ICDAS.
RESULTS


A total of 157 children completed the study, of which 51.0% were female. At the end of the study, 53 participants comprised the control group, 54 were included in the every-3-months (3-month) FV group, and 50 belonged to the every-6-months (6-month) FV group. Adjusted ORs were calculated to compare lesion development between the groups. The results showed that the control group was more likely to develop caries lesions in comparison to the 3-month FV group, with an associated AOR of 1.46 (95% CI: 1.18 to 1.81, p = 0.001). Likewise, applying FV every six months as opposed to every three increased the odds of developing caries with a significant AOR of 1.29 (95% CI: 1.03 to 1.64, p = 0.029).
CONCLUSION


FV application every three months can be recommended to prevent caries lesions on the erupting first permanent molars of high-risk populations.",2019,"The results showed that the control group was more likely to develop caries lesions in comparison to the 3-month FV group, with an associated AOR of 1.46 (95% CI: 1.18 to 1.81, p = 0.001).","['caries lesions on the erupting first permanent molars (FPM) of high-risk children', '180 children between 6 and 7 years of age with at least one sound erupting FPM attending a public school in the Dominican Republic', '157 children completed the study, of which 51.0% were female', '53 participants comprised the control group, 54 were included in the every-3-months (3-month) FV group, and 50 belonged to the every-6-months (6-month) FV group']","['Fluoride Varnish', 'fluoride varnish (FV', 'fluoride toothpaste']","['Caries Lesions', 'develop caries lesions', 'caries lesions']","[{'cui': 'C0333519', 'cui_str': 'Caries (morphologic abnormality)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0205355', 'cui_str': 'Permanent (qualifier value)'}, {'cui': 'C0026367', 'cui_str': 'Molar'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1293120', 'cui_str': 'Sounding'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0557800', 'cui_str': 'Public school (environment)'}, {'cui': 'C0013014', 'cui_str': 'Dominican Republic'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0585339', 'cui_str': 'q6mo'}]","[{'cui': 'C0016326', 'cui_str': 'Fluoride Varnishes'}, {'cui': 'C0016327', 'cui_str': 'Fluorides'}, {'cui': 'C0040462', 'cui_str': 'Toothpaste'}]","[{'cui': 'C0333519', 'cui_str': 'Caries (morphologic abnormality)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}]",53.0,0.0597927,"The results showed that the control group was more likely to develop caries lesions in comparison to the 3-month FV group, with an associated AOR of 1.46 (95% CI: 1.18 to 1.81, p = 0.001).","[{'ForeName': 'Ninoska', 'Initials': 'N', 'LastName': 'Abreu-Placeres', 'Affiliation': ''}, {'ForeName': 'Luis Eduardo', 'Initials': 'LE', 'LastName': 'Garrido', 'Affiliation': ''}, {'ForeName': 'Isaury', 'Initials': 'I', 'LastName': 'Castillo Jáquez', 'Affiliation': ''}, {'ForeName': 'Leandro E', 'Initials': 'LE', 'LastName': 'Féliz-Matos', 'Affiliation': ''}]",Oral health & preventive dentistry,['10.3290/j.ohpd.a43566']
3572,32052432,A randomized controlled trial on the impact of healing time on wound healing following ridge preservation using a 70%/30% combination of mineralized and demineralized freeze-dried bone allograft.,"BACKGROUND


To compare the histologic difference in healing between ridge preservation sites treated with a combination allograft of 70% mineralized and 30% demineralized freeze-dried bone allograft (FDBA) evaluated at 8 to 10 weeks versus 18 to 20 weeks post-extraction. Changes in morphological ridge dimensions were also evaluated.
METHODS


Forty-four patients with a single-rooted tooth to be extracted and replaced by a dental implant were recruited for this study. At time of extraction, measurements were taken with a custom acrylic stent, and the extraction socket was grafted with the combination allograft and covered with a nonresorbable membrane. Patients were randomly assigned to the short-term (8 to 10 weeks) or long-term (18 to 20 weeks) healing group. Sites were re-entered for study measurements, a bone core sample, and implant placement. Bone cores obtained during implant placement were analyzed histologically to determine percentages of vital bone, residual graft, and CT/other.
RESULTS


Thirty-eight of the 44 patients completed the study, 19 in each group. There was a significant difference between the two groups for mean percent vital bone formation (short-term = 18.17%, long-term = 40.32%, P = < 0.0001) and percentage of residual graft (short-term = 41.54%, long-term = 23.59%, P = < 0.0001). There was no difference in morphological changes between the two groups.
CONCLUSION


Ridge preservation using combination FDBA resulted in approximately twice as much vital bone and half as much residual graft material after 18 to 20 weeks of healing compared to only 8 to 10 weeks healing.",2020,"There was a significant difference between the two groups for mean percent vital bone formation (short-term = 18.17%, long-term = 40.32%, p = <.0001) and percentage of residual graft (short-term = 41.54%, long-term = 23.59%, p = <.0001).","['Thirty-eight of the 44 patients completed the study, 19 in each group', 'Forty-four patients with a single-rooted tooth to be extracted and replaced by a dental implant were recruited for this study']",['mineralized and demineralized freeze-dried bone allograft'],"['percentage of residual graft', 'morphological changes', 'wound healing', 'morphological ridge dimensions', 'mean percent vital bone formation']","[{'cui': 'C0450361', 'cui_str': '38 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0563017', 'cui_str': 'Anal penetration using finger (finding)'}, {'cui': 'C0040426', 'cui_str': 'Tooth'}, {'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}, {'cui': 'C1299987', 'cui_str': 'REPLACED BY (attribute)'}, {'cui': 'C0011373', 'cui_str': 'Dental Implants'}]","[{'cui': 'C0016698', 'cui_str': 'Lyophilization'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0450127', 'cui_str': 'Allogeneic Grafts'}]","[{'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0332243', 'cui_str': 'Ridging (qualifier value)'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0442732', 'cui_str': 'Vital (qualifier value)'}, {'cui': 'C0029433', 'cui_str': 'Ossification'}]",44.0,0.103988,"There was a significant difference between the two groups for mean percent vital bone formation (short-term = 18.17%, long-term = 40.32%, p = <.0001) and percentage of residual graft (short-term = 41.54%, long-term = 23.59%, p = <.0001).","[{'ForeName': 'Aaron C', 'Initials': 'AC', 'LastName': 'Nelson', 'Affiliation': 'Department of Periodontics, UT Health San Antonio, San Antonio, TX.'}, {'ForeName': 'Brian L', 'Initials': 'BL', 'LastName': 'Mealey', 'Affiliation': 'Department of Periodontics, UT Health San Antonio, San Antonio, TX.'}]",Journal of periodontology,['10.1002/JPER.19-0610']
3573,32053534,"Reply to: ""The Analgesic Effects of Liposomal Bupivacaine versus Bupivacaine Hydrochloride Administered as a Transversus Abdominis Plane Block after Abdominally Based Autologous Microvascular Breast Reconstruction: A Prospective, Single-Blind, Randomized, Controlled Trial"".",,2020,,['Transversus Abdominis Plane Block after Abdominally Based Autologous Microvascular Breast Reconstruction'],"['Bupivacaine Hydrochloride', 'Liposomal Bupivacaine']",[],"[{'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0443258', 'cui_str': 'Microvascular (qualifier value)'}, {'cui': 'C0085076', 'cui_str': 'Breast Reconstruction'}]","[{'cui': 'C0887621', 'cui_str': 'Bupivacaine Hydrochloride'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]",[],,0.155102,,"[{'ForeName': 'Austin Y', 'Initials': 'AY', 'LastName': 'Ha', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, Washington University School of Medicine, Saint Louis, MO.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Guffey', 'Affiliation': 'Department of Anesthesiology, Washington University School of Medicine, Saint Louis, MO.'}, {'ForeName': 'Terence M', 'Initials': 'TM', 'LastName': 'Myckatyn', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, Washington University School of Medicine, Saint Louis, MO.'}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000006783']
3574,32053841,Differential Impact of Insulin Sensitizers vs. Anti-Androgen on Serum Leptin Levels in Vitamin D Replete PCOS Women: A Six Month Open Labeled Randomized Study.,"Women with PCOS are linked to insulin resistance, inflammation, and vitamin D (VD) deficiency. The study endeavors to comprehend the differential impact of insulin sensitizers vs. anti-androgen on serum leptin levels among women with PCOS rendered vitamin D replete with high VD oral supplement. This was open-labeled randomized study that screened 180 eligible women presenting to Endocrine clinic with oligomenorrhea or features of hyperandrogenism. Ninety-nine women who furnished written informed consent and fulfilled the Rotterdam 2003 criteria for diagnosis of PCOS were randomized into 3 drug treatment arms to receive either spironolactone (50 mg/d; n=30), metformin (1000 mg/d; n=30) or pioglitazone (30 mg/d; n=30). These women were also administered oral VD (4000 IU/day) in addition to the allocated drug for a period of 6 months. Detailed history, clinical examination, and laboratory evaluation was carried out at baseline and 6 months after intervention. Number of menstrual cycles/year increased while as Ferriman-Gallwey score, blood glucose, HOMA-IR, and plasma insulin levels significantly decreased in all the three arms with better outcomes in spironolactone and pioglitazone arms (p<0.05). Similarly, serum leptin levels superiorly improved in spironolactone and pioglitazone group. Pioglitazone group showed better efficacy in lowering serum total testosterone (p<0.05). Co-supplementation of high dosage VD with spironolactone or pioglitazone are more effective in reducing plasma leptin levels than metformin, and thus might prove to be better therapeutic strategies for women with PCOS.",2020,Pioglitazone group showed better efficacy in lowering serum total testosterone (p<0.05).,"['180 eligible women presenting to Endocrine clinic with oligomenorrhea or features of hyperandrogenism', 'women with PCOS', 'Ninety-nine women who furnished written informed consent and fulfilled the Rotterdam 2003 criteria for diagnosis of PCOS', 'Women with PCOS', 'Vitamin D Replete PCOS Women', 'women with PCOS rendered vitamin D replete with high VD oral supplement']","['metformin', 'spironolactone or pioglitazone', 'pioglitazone', 'Pioglitazone', 'Insulin Sensitizers vs. Anti-Androgen', 'spironolactone', 'oral VD', 'insulin sensitizers vs. anti-androgen']","['Number of menstrual cycles/year increased while as Ferriman-Gallwey score, blood glucose, HOMA-IR, and plasma insulin levels', 'Serum Leptin Levels', 'plasma leptin levels', 'serum leptin levels', 'lowering serum total testosterone', 'serum leptin levels superiorly', 'insulin resistance, inflammation, and vitamin D (VD) deficiency']","[{'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0028949', 'cui_str': 'Oligomenorrhea'}, {'cui': 'C0206081', 'cui_str': 'Hyperandrogenism'}, {'cui': 'C3828813', 'cui_str': 'Ninety-nine'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0037982', 'cui_str': 'Spironolactone'}, {'cui': 'C0071097', 'cui_str': 'pioglitazone'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C3540699', 'cui_str': 'Anti-androgen hormone antagonists and related agents'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C4553712', 'cui_str': 'Onset of menstrual cycle'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C1276042', 'cui_str': 'Plasma insulin measurement'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D Deficiency'}]",99.0,0.0460859,Pioglitazone group showed better efficacy in lowering serum total testosterone (p<0.05).,"[{'ForeName': 'Aafia', 'Initials': 'A', 'LastName': 'Rashid', 'Affiliation': 'Department of Endocrinology, Sheri-Kashmir Institute of Medical Sciences, Srinagar, India.'}, {'ForeName': 'Mohd Ashraf', 'Initials': 'MA', 'LastName': 'Ganie', 'Affiliation': 'Department of Endocrinology, Sheri-Kashmir Institute of Medical Sciences, Srinagar, India.'}, {'ForeName': 'Imtiyaz Ahmad', 'Initials': 'IA', 'LastName': 'Wani', 'Affiliation': 'Department of Endocrinology, Sheri-Kashmir Institute of Medical Sciences, Srinagar, India.'}, {'ForeName': 'Gulzar Ahmad', 'Initials': 'GA', 'LastName': 'Bhat', 'Affiliation': 'Department of Endocrinology, Sheri-Kashmir Institute of Medical Sciences, Srinagar, India.'}, {'ForeName': 'Feroz', 'Initials': 'F', 'LastName': 'Shaheen', 'Affiliation': 'Department of Radio-Diagnosis, Sheri-Kashmir Institute of Medical Sciences, Srinagar, India.'}, {'ForeName': 'Ishfaq Ahmed', 'Initials': 'IA', 'LastName': 'Wani', 'Affiliation': 'Department of Endocrinology, Sheri-Kashmir Institute of Medical Sciences, Srinagar, India.'}, {'ForeName': 'Mukesh', 'Initials': 'M', 'LastName': 'Shrivastava', 'Affiliation': 'Department of Endocrinology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Zaffar Amin', 'Initials': 'ZA', 'LastName': 'Shah', 'Affiliation': 'Department of Immunology & Molecular Medicine, Sheri-Kashmir Institute of Medical Sciences, Srinagar, India.'}]",Hormone and metabolic research = Hormon- und Stoffwechselforschung = Hormones et metabolisme,['10.1055/a-1084-5441']
3575,31918942,Fractional Flow Reserve or Optical Coherence Tomography to Guide Management of Angiographically Intermediate Coronary Stenosis: A Single-Center Trial.,"OBJECTIVES


The aim of this study was to compare optical coherence tomographic (OCT) guidance and fractional flow reserve (FFR) guidance in patients with angiographically intermediate coronary lesions (AICLs) in a single-center, prospective, 1:1 randomized trial.
BACKGROUND


FFR and OCT imaging may help both in the assessment of AICLs and in percutaneous coronary intervention optimization.
METHODS


Patients with AICLs were randomized to FFR or OCT imaging. In the FFR arm, PCI was performed if FFR was ≤0.80. In the OCT imaging arm, PCI was performed if area stenosis was ≥75% or 50% to 75% with minimal luminal area <2.5 mm 2  or plaque rupture. Angina (evaluated using the Seattle Angina Questionnaire), major adverse cardiac events, and cost were assessed at the end of follow-up. The pre-defined primary endpoint was the composite of major adverse cardiac events or significant angina (defined as Seattle Angina Questionnaire frequency scale score <90) at 13 months.
RESULTS


A total of 350 patients (with 446 AICLs) were enrolled (176 randomized to FFR and 174 to OCT imaging). The primary endpoint of major adverse cardiac events or significant angina at 13 months occurred in 14.8% of patients in the FFR arm and in 8.0% in the OCT imaging arm (p = 0.048). This result was driven by a statistically nonsignificant lower occurrence of all primary endpoint components. Up to 13 months, the rate of medically managed patients was significantly higher (p < 0.001) and total cost significantly lower (p < 0.001) with FFR in comparison with OCT imaging.
CONCLUSIONS


In patients with AICLs, OCT guidance is associated with lower occurrence of the composite of major adverse cardiac events or significant angina. FFR guidance is associated with a higher rate of medical management and lower costs. FFR or OCT Guidance to Revascularize Intermediate Coronary Stenosis Using Angioplasty [FORZA]; NCT01824030).",2020,"Up to 13 months, the rate of medically managed patients was significantly higher (p < 0.001) and total cost significantly lower (p < 0.001) with FFR in comparison with OCT imaging.
","['patients with angiographically intermediate coronary lesions (AICLs', 'Patients with AICLs', '350 patients (with 446 AICLs) were enrolled (176 randomized to FFR and 174 to OCT imaging']","['FFR or OCT imaging', 'optical coherence tomographic (OCT) guidance and fractional flow reserve (FFR) guidance', 'Fractional Flow Reserve or Optical Coherence Tomography']","['major adverse cardiac events or significant angina at 13\xa0months', 'composite of major adverse cardiac events or significant angina (defined as Seattle Angina Questionnaire frequency scale score', 'total cost', 'Angina (evaluated using the Seattle Angina Questionnaire), major adverse cardiac events, and cost']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C4517604', 'cui_str': 'One hundred and seventy-four'}]","[{'cui': 'C1299469', 'cui_str': 'Fractional flow reserve'}, {'cui': 'C0920367', 'cui_str': 'Tomography, Optical Coherence'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0002962', 'cui_str': 'Stenocardia'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",176.0,0.0356894,"Up to 13 months, the rate of medically managed patients was significantly higher (p < 0.001) and total cost significantly lower (p < 0.001) with FFR in comparison with OCT imaging.
","[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Burzotta', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy; Università Cattolica del Sacro Cuore, Rome, Italy. Electronic address: francesco.burzotta@unicatt.it.'}, {'ForeName': 'Antonio Maria', 'Initials': 'AM', 'LastName': 'Leone', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Aurigemma', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.'}, {'ForeName': 'Aniello', 'Initials': 'A', 'LastName': 'Zambrano', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy; Università Cattolica del Sacro Cuore, Rome, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Zimbardo', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.'}, {'ForeName': 'Manfredi', 'Initials': 'M', 'LastName': 'Arioti', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy; Università Cattolica del Sacro Cuore, Rome, Italy.'}, {'ForeName': 'Rocco', 'Initials': 'R', 'LastName': 'Vergallo', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy; Università Cattolica del Sacro Cuore, Rome, Italy.'}, {'ForeName': 'Giovanni Luigi', 'Initials': 'GL', 'LastName': 'De Maria', 'Affiliation': 'Department of Cardiology, John Radcliffe Hospital, Oxford University Hospitals NHS Foundation Trust, Oxford, United Kingdom.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Cerracchio', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy; Università Cattolica del Sacro Cuore, Rome, Italy.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Romagnoli', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy; Università Cattolica del Sacro Cuore, Rome, Italy.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Trani', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy; Università Cattolica del Sacro Cuore, Rome, Italy.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Crea', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy; Università Cattolica del Sacro Cuore, Rome, Italy.'}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2019.09.034']
3576,31949042,Scheduled afternoon-evening sleep leads to better night shift performance in older adults.,"OBJECTIVES


This study investigated whether an intervention designed to reduce homeostatic sleep pressure would improve night shift performance and alertness in older adults.
METHODS


Non-shift workers aged 57.9±4.6 (mean±SD) worked four day (07:00-15:00) and four night shifts (23:00-07:00). Two intervention groups were instructed to remain awake until ~13:00 after each night shift: the sleep timing group (ST; n=9) was instructed to spend 8 hours in bed attempting sleep, and the sleep ad-lib group (n=9) was given no further sleep instructions. A control group (n=9) from our previous study was not given any sleep instructions. Hourly Karolinska Sleepiness Scales and Psychomotor Vigilance Tasks assessed subjective sleepiness and performance.
RESULTS


The ST group maintained their day shift sleep durations on night shifts, whereas the control group slept less. The ST group were able to maintain stable performance and alertness across the initial part of the night shift, while the control group's alertness and performance declined across the entire night. Wake duration before a night shift negatively impacted sustained attention and self-reported sleepiness but not reaction time, whereas sleep duration before a night shift affected reaction time and ability to sustain attention but not self-reported sleepiness.
CONCLUSIONS


A behavioural change under the control of the individual worker, spending 8 hours in bed and waking close to the start of the night shift, allowed participants to acquire more sleep and improved performance on the night shift in older adults. Both sleep duration and timing are important factors for night shift performance and self-reported sleepiness.",2020,"This study investigated whether an intervention designed to reduce homeostatic sleep pressure would improve night shift performance and alertness in older adults.
","['Non-shift workers aged 57.9±4.6 (mean±SD) worked four\u2009day (07:00-15:00) and four night shifts (23:00-07:00', 'older adults']","['remain awake until ~13:00\u2009after each night shift: the sleep timing group (ST; n=9) was instructed to spend 8\u2009hours in bed attempting sleep, and the sleep ad-lib group (n=9) was given no further sleep instructions']","['homeostatic sleep pressure', 'Hourly Karolinska Sleepiness Scales and Psychomotor Vigilance Tasks assessed subjective sleepiness and performance']","[{'cui': 'C0425104', 'cui_str': 'Shift worker (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0333051', 'cui_str': 'Shift (morphologic abnormality)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0234422', 'cui_str': 'Awake (finding)'}, {'cui': 'C0333051', 'cui_str': 'Shift (morphologic abnormality)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0449243', 'cui_str': 'Timing (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1292429', 'cui_str': '8 hours (qualifier value)'}, {'cui': 'C0004916', 'cui_str': 'Beds'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0558292', 'cui_str': 'Hourly (qualifier value)'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0222045'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}]",,0.00963091,"This study investigated whether an intervention designed to reduce homeostatic sleep pressure would improve night shift performance and alertness in older adults.
","[{'ForeName': 'Cheryl Martine', 'Initials': 'CM', 'LastName': 'Isherwood', 'Affiliation': ""Division of Sleep and Circadian Disorders, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Evan D', 'Initials': 'ED', 'LastName': 'Chinoy', 'Affiliation': ""Division of Sleep and Circadian Disorders, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Audra S', 'Initials': 'AS', 'LastName': 'Murphy', 'Affiliation': ""Division of Sleep and Circadian Disorders, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Jee Hyun', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': ""Division of Sleep and Circadian Disorders, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': ""Division of Sleep and Circadian Disorders, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Jeanne F', 'Initials': 'JF', 'LastName': 'Duffy', 'Affiliation': ""Division of Sleep and Circadian Disorders, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA jduffy@research.bwh.harvard.edu.""}]",Occupational and environmental medicine,['10.1136/oemed-2019-105916']
3577,32067218,Decreased Circulating MANF in Women with PCOS is Elevated by Metformin Therapy and is Inversely Correlated with Insulin Resistance and Hyperandrogenism.,"Mesencephalic astrocyte-derived neurotrophic factor (MANF) is a novel neurotrophic factor. Although recent studies have suggested that MANF appeared to be associated with insulin resistance, the results have been inconsistent. The aim of our study was to determine the serum MANF levels in women with PCOS and controls, to investigate their relationship to insulin resistance, and to evaluate circulating MANF changes with metformin intervention in PCOS women. We conducted a series of cross-sectional and interventional studies in 90 newly diagnosed patients with PCOS and 60 age- and gender-matched controls. Oral glucose tolerance test and euglycemic-hyperinsulinemic clamps were performed to assess the glucose tolerance and insulin sensitivity. Forty-three women with PCOS were randomly assigned to six months of oral metformin therapy. Serum MANF levels were significantly lower in women with PCOS than in controls. Serum MANF levels were positively correlated with M-value and negatively correlated with body mass index (BMI), body fat percentage (FAT), homeostatic model assessment of insulin resistance (HOMA-IR), and free androgen index (FAI). Multivariate stepwise regression demonstrated that serum MANF levels were independently associated with M-value and FAI. After six months of metformin treatment, there was a significant increase in serum MANF levels in PCOS women. Serum MANF levels are decreased in women with PCOS, and are reversely related to insulin resistance and hyperandrogenism. Metformin treatment elevates serum MANF levels and alleviates insulin resistance and hyperandrogenism in PCOS women.",2020,Serum MANF levels were significantly lower in women with PCOS than in controls.,"['90 newly diagnosed patients with PCOS and 60 age- and gender-matched controls', 'women with PCOS', 'Forty-three women with PCOS', 'PCOS women', 'women with PCOS and controls']","['metformin', 'metformin intervention', 'Metformin', 'Oral glucose tolerance test and euglycemic-hyperinsulinemic clamps', 'Mesencephalic astrocyte-derived neurotrophic factor (MANF', 'MANF', 'oral metformin therapy']","['serum MANF levels', 'serum MANF levels and alleviates insulin resistance and hyperandrogenism', 'Serum MANF levels', 'glucose tolerance and insulin sensitivity', 'body mass index (BMI), body fat percentage (FAT), homeostatic model assessment of insulin resistance (HOMA-IR), and free androgen index (FAI', 'Insulin Resistance and Hyperandrogenism']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0450368', 'cui_str': '43 (qualifier value)'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}, {'cui': 'C0004112', 'cui_str': 'Astroglia'}, {'cui': 'C0027754', 'cui_str': 'Neurotrophic Factors'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0206081', 'cui_str': 'Hyperandrogenism'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0428629', 'cui_str': 'Free androgen index measurement'}]",43.0,0.033237,Serum MANF levels were significantly lower in women with PCOS than in controls.,"[{'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Wei', 'Affiliation': 'Department of Endocrinology and Metabolism, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Cong', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Endocrinology and Metabolism, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Gangyi', 'Initials': 'G', 'LastName': 'Yang', 'Affiliation': 'Department of Endocrinology and Metabolism, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Yanjun', 'Initials': 'Y', 'LastName': 'Jia', 'Affiliation': 'Laboratory of Endocrinology, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Endocrinology and Metabolism, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Wenzhen', 'Initials': 'W', 'LastName': 'Deng', 'Affiliation': 'Department of Endocrinology and Metabolism, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Long', 'Affiliation': 'Department of Endocrinology and Metabolism, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Chengpan', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Endocrinology and Metabolism, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Dongfang', 'Initials': 'D', 'LastName': 'Liu', 'Affiliation': 'Department of Endocrinology and Metabolism, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}]",Hormone and metabolic research = Hormon- und Stoffwechselforschung = Hormones et metabolisme,['10.1055/a-1082-1080']
3578,31356508,Physical Activity Is Higher in Patients with LVADs Compared to Chronic Heart Failure.,"PURPOSE


Left ventricular assist devices (LVADs) are associated with an increased aerobic capacity in patients with chronic heart failure (CHF). However, studies evaluating the impact of LVAD implantation on physical activity (PA) are lacking. The aim of this study was to compare daily PA levels in participants with LVADs with well-matched CHF participants.
METHODS


Sixteen participants with an LVAD (age: 59.1 ± 10.8 years) were case-matched to 16 participants with advanced CHF (age: 58.3 ± 8.7 years), who were listed or being considered for cardiac transplantation. Participants underwent a cardiopulmonary exercise test to determine peak oxygen consumption (V[Combining Dot Above]O2 peak). PA was monitored continuously for seven consecutive days with an Actiheart monitor.
RESULTS


V[Combining Dot Above]O2 peak in the CHF group (12.3 ± 3.5 ml·kg·min) was not significantly different to the LVAD group prior to LVAD implantation (10.4 ± 2.1 ml·kg·min), but was lower than in the LVAD group following implantation (15.8 ± 4.3 ml·kg·min; p < 0.05). PA was higher in the LVAD (19.7 ± 6.4 kJ·kg·day) compared with the CHF group (11.6 ± 6.9 kJ·kg·day; p = 0.001). LVAD participants spent more time performing moderate intensity PA than their CHF counterparts, 26 (24-40) [median (IQR)] vs. 12 (9-16) min/day; p < 0.001. PA was correlated with V[Combining Dot Above]O2 peak (r = 0.582; p = 0.001) across participants in the CHF and LVAD groups.
CONCLUSION


Higher levels of PA were observed in participants with LVAD compared with patients with advanced CHF. This may be due to a higher V[Combining Dot Above]O2 peak, resulting in an improved capacity to perform activities of daily living with less symptoms.",2019,PA was higher in the LVAD (19.7 ± 6.4 kJ·kg·day) compared with the CHF group (11.6 ± 6.9 kJ·kg·day; p = 0.001).,"['Sixteen participants with an LVAD (age: 59.1 ± 10.8 years) were case-matched to 16 participants with advanced CHF (age: 58.3 ± 8.7 years), who were listed or being considered for cardiac transplantation', 'patients with chronic heart failure (CHF', 'participants with LVADs with well-matched CHF participants']","['LVAD implantation', 'Left ventricular assist devices (LVADs', 'cardiopulmonary exercise test', 'LVAD']","['Dot Above]O2 peak', 'time performing moderate intensity PA', 'V[Combining Dot Above]O2 peak', 'PA', 'peak oxygen consumption (V[Combining Dot Above]O2 peak', 'Physical Activity', 'aerobic capacity', 'daily PA levels', 'Higher levels of PA']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517523', 'cui_str': '10.8'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C4517880', 'cui_str': '8.7 (qualifier value)'}, {'cui': 'C0018823', 'cui_str': 'Transplantation, Cardiac'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0264716', 'cui_str': 'Chronic heart failure (disorder)'}]","[{'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C2959886', 'cui_str': 'Cardiopulmonary Exercise Test'}]","[{'cui': 'C1720485', 'cui_str': 'Corneal epithelial microcysts'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",16.0,0.0464878,PA was higher in the LVAD (19.7 ± 6.4 kJ·kg·day) compared with the CHF group (11.6 ± 6.9 kJ·kg·day; p = 0.001).,"[{'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Moreno-Suarez', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, Australia.'}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Liew', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, Australia.'}, {'ForeName': 'Lawrence G', 'Initials': 'LG', 'LastName': 'Dembo', 'Affiliation': 'Advanced Heart Failure and Cardiac Transplant Service, Fiona Stanley Hospital, Murdoch, Australia.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Larbalestier', 'Affiliation': 'Advanced Heart Failure and Cardiac Transplant Service, Fiona Stanley Hospital, Murdoch, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Maiorana', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, Australia.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002104']
3579,31246661,Fractional CO2 laser versus promestriene and lubricant in genitourinary syndrome of menopause: a randomized clinical trial.,"OBJECTIVE


The aim of this study was to compare the effects of fractional CO2 laser therapy, promestriene, and vaginal lubricants on genitourinary syndrome treatment and sexual function in postmenopausal women.
METHODS


We performed a randomized clinical trial including 72 postmenopausal women over the age of 50 years. The women were randomized into three intervention groups to receive one of the following treatments: three sessions of intravaginal fractional CO2 laser therapy; 10 mg of intravaginal promestriene cream 3 times a week; and vaginal lubricant application alone. Vaginal maturation, Vaginal Health Index (VHI) score, and Female Sexual Function Index (FSFI) were evaluated at baseline and after 14 weeks of therapy.
RESULTS


We observed an improvement in the vaginal elasticity, volume, moisture, and pH in the CO2 laser and promestriene groups. The VHI score at 14 weeks was higher in the CO2 laser group (mean score 18.68) than in the promestriene (15.11) and lubricant (10.44) groups (P < 0.001). Regarding vaginal maturation, basal cells were reduced and superficial cells were increased after treatment. This improvement was more significant in the CO2 laser group (P <0.001). The FSFI score only showed improvement in the desire and lubrication domains in the CO2 laser group. There were no differences in total FSFI score among the three treatment groups. There were no adverse effects associated with any of the treatments.
CONCLUSIONS


The use of fractional CO2 laser therapy to treat genitourinary syndrome resulted in better short-term effects than those of promestriene or lubricant with respect to improving the vaginal health in postmenopausal women.",2019,The use of fractional CO2 laser therapy to treat genitourinary syndrome resulted in better short-term effects than those of promestriene or lubricant with respect to improving the vaginal health in postmenopausal women.,"['postmenopausal women', 'genitourinary syndrome of menopause', '72 postmenopausal women over the age of 50 years']","['fractional CO2 laser therapy', 'CO2 laser', 'promestriene or lubricant', 'Fractional CO2 laser versus promestriene and lubricant', 'fractional CO2 laser therapy, promestriene, and vaginal lubricants', 'intravaginal fractional CO2 laser therapy; 10\u200amg of intravaginal promestriene cream 3 times a week; and vaginal lubricant application alone']","['vaginal health', 'desire and lubrication domains', 'Vaginal maturation, Vaginal Health Index (VHI) score, and Female Sexual Function Index (FSFI', 'total FSFI score', 'vaginal maturation, basal cells', 'VHI score', 'FSFI score', 'vaginal elasticity, volume, moisture, and pH', 'superficial cells']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0567312', 'cui_str': 'Menopause present (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0392251', 'cui_str': 'CO2 Lasers'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0072151', 'cui_str': 'promestriene'}, {'cui': 'C0282222', 'cui_str': 'Lubrication Agents'}, {'cui': 'C0356770', 'cui_str': 'Vaginal lubricant'}, {'cui': 'C0442122', 'cui_str': 'Intravaginal (qualifier value)'}, {'cui': 'C1378128', 'cui_str': 'Cream'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}]","[{'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1318469', 'cui_str': 'Lubrication'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0278098', 'cui_str': 'Female sexual function (observable entity)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0013764'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0205124', 'cui_str': 'Superficial (qualifier value)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}]",72.0,0.0695038,The use of fractional CO2 laser therapy to treat genitourinary syndrome resulted in better short-term effects than those of promestriene or lubricant with respect to improving the vaginal health in postmenopausal women.,"[{'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Politano', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medical Sciences, State University of Campinas-UNICAMP Campinas, São Paulo, Brazil.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Costa-Paiva', 'Affiliation': ''}, {'ForeName': 'Luiza B', 'Initials': 'LB', 'LastName': 'Aguiar', 'Affiliation': ''}, {'ForeName': 'Helymar C', 'Initials': 'HC', 'LastName': 'Machado', 'Affiliation': ''}, {'ForeName': 'Luiz F', 'Initials': 'LF', 'LastName': 'Baccaro', 'Affiliation': ''}]","Menopause (New York, N.Y.)",['10.1097/GME.0000000000001333']
3580,31351901,Isokinetic eccentric training is more effective than constant load eccentric training for quadriceps rehabilitation following anterior cruciate ligament reconstruction: a randomized controlled trial.,"OBJECTIVE


To compare the effects of conventional (constant load) eccentric training and isokinetic eccentric training on quadriceps muscle mass, strength and functional performance in recreational athletes following anterior cruciate ligament (ACL) reconstruction.
METHODS


Thirty recreational male athletes (25 years old) undergoing ACL reconstruction received a standard rehabilitation program. Volunteers were randomized to conventional group (CG; n = 15) or isokinetic group (IG; n = 15) to be engaged in a 6-week (2 sessions/week) quadriceps eccentric training program at the extensor chair or at the isokinetic dynamometer, respectively. Assessments of quadriceps muscle mass (through magnetic resonance imaging), strength (through isokinetic dynamometry) and self-aware functionality (through questionnaire) were performed before and after the training programs. Single leg hop test performance was assessed only at post-training evaluation.
RESULTS


IG had significantly higher improvements than CG (p < 0.05) for all muscle mass outcomes (+17-23% vs. +5-9%), as well as for isometric (+34% vs. +20%) and eccentric (+85% vs. +23%) peak torques. There was no between-group difference (p > 0.05) for concentric peak torque, Lysholm score, and single leg hop test.
CONCLUSION


Isokinetic eccentric training promotes greater responses than conventional eccentric training on quadriceps muscle mass and strength of recreational athletes following ACL reconstruction.",2020,"RESULTS


IG had significantly higher improvements than CG (p < 0.05) for all muscle mass outcomes (+17-23% vs. +5-9%), as well as for isometric (+34% vs. +20%) and eccentric (+85% vs. +23%) peak torques.","['anterior cruciate ligament reconstruction', 'recreational athletes following anterior cruciate ligament (ACL) reconstruction', 'Thirty recreational male athletes (˜25 years old) undergoing']","['conventional (constant load) eccentric training and isokinetic eccentric training', 'Isokinetic eccentric training', 'ACL reconstruction received a standard rehabilitation program', 'constant load eccentric training', 'conventional eccentric training', 'conventional group (CG; n\u202f=\u202f15) or isokinetic group (IG; n\u202f=\u202f15) to be engaged in a 6-week (2 sessions/week) quadriceps eccentric training program at the extensor chair or at the isokinetic dynamometer, respectively']","['strength (through isokinetic dynamometry) and self-aware functionality (through questionnaire', 'quadriceps muscle mass, strength and functional performance', 'concentric peak torque, Lysholm score, and single leg hop test', 'peak torques', 'quadriceps muscle mass and strength of recreational athletes']","[{'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0439740', 'cui_str': 'Eccentric (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0524865', 'cui_str': 'Reconstructive Surgery'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0179847', 'cui_str': 'Chair (physical object)'}, {'cui': 'C0180572', 'cui_str': 'Dynamometer (physical object)'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle (finding)'}, {'cui': 'C3853978'}, {'cui': 'C0439744', 'cui_str': 'Concentric (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0376590', 'cui_str': 'Torque'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C4018995', 'cui_str': 'Hop'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]",,0.0180957,"RESULTS


IG had significantly higher improvements than CG (p < 0.05) for all muscle mass outcomes (+17-23% vs. +5-9%), as well as for isometric (+34% vs. +20%) and eccentric (+85% vs. +23%) peak torques.","[{'ForeName': 'Marlon Francys', 'Initials': 'MF', 'LastName': 'Vidmar', 'Affiliation': 'Graduate Program in Rehabilitation Sciences, Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, RS, Brazil; Hospital Ortopédico de Passo Fundo, Passo Fundo, RS, Brazil. Electronic address: marlonfrancys@msn.com.'}, {'ForeName': 'Bruno Manfredini', 'Initials': 'BM', 'LastName': 'Baroni', 'Affiliation': 'Graduate Program in Rehabilitation Sciences, Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, RS, Brazil.'}, {'ForeName': 'Alexandre Fróes', 'Initials': 'AF', 'LastName': 'Michelin', 'Affiliation': 'Hospital Ortopédico de Passo Fundo, Passo Fundo, RS, Brazil.'}, {'ForeName': 'Márcio', 'Initials': 'M', 'LastName': 'Mezzomo', 'Affiliation': 'Hospital Ortopédico de Passo Fundo, Passo Fundo, RS, Brazil.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Lugokenski', 'Affiliation': 'Hospital Ortopédico de Passo Fundo, Passo Fundo, RS, Brazil.'}, {'ForeName': 'Gilnei Lopes', 'Initials': 'GL', 'LastName': 'Pimentel', 'Affiliation': 'Physical Therapy Department, Universidade de Passo Fundo (UPF), Passo Fundo, RS, Brazil.'}, {'ForeName': 'Marcelo Faria', 'Initials': 'MF', 'LastName': 'Silva', 'Affiliation': 'Graduate Program in Rehabilitation Sciences, Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, RS, Brazil.'}]",Brazilian journal of physical therapy,['10.1016/j.bjpt.2019.07.003']
3581,31805822,"Comparing Three Established Methods for Tinnitus Pitch Matching With Respect to Reliability, Matching Duration, and Subjective Satisfaction.","The pitch of tinnitus sound is a key characteristic that is of importance to research and sound therapies relying on exact tinnitus pitch matches. The identification of this tinnitus pitch is a challenging task as there is no objective measurement available. During the tinnitus pitch-matching procedure, the participant identifies an external sound that is most similar to the subjective perception of the tinnitus. Several methods have been developed to perform this pitch-matching procedure with tinnitus sufferers. In this study, we aimed to compare the method of adjustment, the two-alternative forced-choice (2AFC) method, and the likeness rating (LR) with respect to reliability, matching duration, and subjective satisfaction. Fifty-nine participants with chronic tinnitus were recruited and performed five consecutive runs of tinnitus matching. The participants were randomized to the three different pitch-matching methods. The intraclass correlation coefficients were .67 for method of adjustment, .63 for 2AFC, and .69 for LR, which can be interpreted as good reliability for all the three methods. However, the 2AFC method revealed significant larger within-subject variability than the other measures. Across the five runs and the three different methods, all participants learned to perform the pitch matching faster and with better self-rated accuracy. Comparing the three pitch-matching methods, LR is more time consuming and the participants were less satisfied with the 2AFC method. Overall, the three pitch-matching methods show good reliability. However, we identified differential aspects for improvement in all methods, which are discussed in this article.",2019,"Across the five runs and the three different methods, all participants learned to perform the pitch matching faster and with better self-rated accuracy.",['Fifty-nine participants with chronic tinnitus'],[],[],"[{'cui': 'C3830128', 'cui_str': '59 (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}]",[],[],59.0,0.0457088,"Across the five runs and the three different methods, all participants learned to perform the pitch matching faster and with better self-rated accuracy.","[{'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Neff', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Regensburg, Germany.'}, {'ForeName': 'Berthold', 'Initials': 'B', 'LastName': 'Langguth', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Regensburg, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Schecklmann', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Regensburg, Germany.'}, {'ForeName': 'Ronny', 'Initials': 'R', 'LastName': 'Hannemann', 'Affiliation': 'Sivantos GmbH, Erlangen, Germany.'}, {'ForeName': 'Winfried', 'Initials': 'W', 'LastName': 'Schlee', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Regensburg, Germany.'}]",Trends in hearing,['10.1177/2331216519887247']
3582,32053538,"Reply to: ""The Analgesic Effects of Liposomal Bupivacaine versus Bupivacaine Hydrochloride Administered as a Transversus Abdominis Plane Block after Abdominally Based Autologous Microvascular Breast Reconstruction: A Prospective, Single-Blind, Randomized, Controlled Trial"".",,2020,,['Transversus Abdominis Plane Block after Abdominally Based Autologous Microvascular Breast Reconstruction'],"['Bupivacaine Hydrochloride', 'Liposomal Bupivacaine']",[],"[{'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0443258', 'cui_str': 'Microvascular (qualifier value)'}, {'cui': 'C0085076', 'cui_str': 'Breast Reconstruction'}]","[{'cui': 'C0887621', 'cui_str': 'Bupivacaine Hydrochloride'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]",[],,0.155102,,"[{'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Knackstedt', 'Affiliation': ''}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Gatherwright', 'Affiliation': ''}, {'ForeName': 'Risal', 'Initials': 'R', 'LastName': 'Djohan', 'Affiliation': ''}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000006782']
3583,31996813,Validation of preferred salt concentration in soup based on a randomized blinded experiment in multiple regions in Japan-influence of umami (L-glutamate) on saltiness and palatability of low-salt solutions.,"Sodium reduction is an important public health goal. Individual and population approaches are necessary for reducing the sodium content of processed foods and meals. The aim of the present study is to affirm the effect of monosodium L-glutamate (MSG), an umami substance, on the saltiness or palatability of low-salt solutions and to explore the preferred salt concentration in soup. Five hundred and eighty-four healthy participants from nineteen regions in Japan tasted 0.3, 0.6, and 0.9% NaCl solutions with or without 0.3% MSG. Evaluations of saltiness and palatability for each solution were conducted using a visual analog scale in a double-blinded randomized manner. Saltiness gradually increased depending on the concentration of NaCl. The saltiness of the 0.3% NaCl solution with MSG was rated significantly higher than that without MSG. The palatability ratings were higher for the solutions with MSG than for those without MSG for all NaCl concentrations. In particular, the palatability rating of the 0.3% NaCl solution with MSG was twice as high as that without MSG and was significantly higher than that of the other five test solutions. Furthermore, these results were observed to be approximately the same, irrespective of sex, age, region, etc. Salt reduction is believed to result in a loss of palatability. However, our results suggest that umami can compensate for the loss of palatability caused by salt reduction and that the addition of an appropriate amount of an umami substance can facilitate salt reduction from 0.9 to 0.3% without sacrificing palatability.",2020,The palatability ratings were higher for the solutions with MSG than for those without MSG for all NaCl concentrations.,"['Five hundred and eighty-four healthy participants from nineteen regions in Japan tasted 0.3, 0.6, and 0.9% NaCl solutions with or without 0.3% MSG', 'multiple regions in Japan-influence of umami (L-glutamate) on saltiness and palatability of low-salt solutions']","['MSG', 'monosodium L-glutamate (MSG']","['palatability ratings', 'concentration of NaCl', 'palatability rating']","[{'cui': 'C4517818', 'cui_str': 'Five hundred and eighty'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0450337', 'cui_str': '19 (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0039336', 'cui_str': 'Gustation'}, {'cui': 'C4068885', 'cui_str': 'Zero point three'}, {'cui': 'C4068883', 'cui_str': 'Zero point six'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C4521594', 'cui_str': 'Senior Chief Petty Officer'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0220839', 'cui_str': 'Glutamate'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C3653289', 'cui_str': 'Salt irrigating solutions'}]","[{'cui': 'C4521594', 'cui_str': 'Senior Chief Petty Officer'}, {'cui': 'C0220839', 'cui_str': 'Glutamate'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}]",584.0,0.0340356,The palatability ratings were higher for the solutions with MSG than for those without MSG for all NaCl concentrations.,"[{'ForeName': 'Hitomi', 'Initials': 'H', 'LastName': 'Hayabuchi', 'Affiliation': ""Department of Food Science and Nutrition, Faculty of Human Life and Environment, Nara Women's University, Nara, Japan. s-hayabuchi@fwu.ac.jp.""}, {'ForeName': 'Rieko', 'Initials': 'R', 'LastName': 'Morita', 'Affiliation': ""Graduate School of Health and Environmental Sciences, Fukuoka Women's University, Fukuoka, Japan.""}, {'ForeName': 'Masanori', 'Initials': 'M', 'LastName': 'Ohta', 'Affiliation': ""Graduate School of Health and Environmental Sciences, Fukuoka Women's University, Fukuoka, Japan.""}, {'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Nanri', 'Affiliation': ""Graduate School of Health and Environmental Sciences, Fukuoka Women's University, Fukuoka, Japan.""}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Matsumoto', 'Affiliation': 'Research Institute for Bioscience Products & Fine Chemicals, Ajinomoto Co., Inc, Kawasaki, Japan.'}, {'ForeName': 'Shoji', 'Initials': 'S', 'LastName': 'Fujitani', 'Affiliation': 'Research Institute for Bioscience Products & Fine Chemicals, Ajinomoto Co., Inc, Kawasaki, Japan.'}, {'ForeName': 'Shintaro', 'Initials': 'S', 'LastName': 'Yoshida', 'Affiliation': 'Research Institute for Bioscience Products & Fine Chemicals, Ajinomoto Co., Inc, Kawasaki, Japan.'}, {'ForeName': 'Sadayoshi', 'Initials': 'S', 'LastName': 'Ito', 'Affiliation': 'Division of Nephrology, Endocrinology and Hypertension, Tohoku University Graduate Medicine, Sendai, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Sakima', 'Affiliation': 'Health Administration Center, University of the Ryukyus, Okinawa, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Takase', 'Affiliation': 'Enshu Hospital, Hamamatsu, Japan.'}, {'ForeName': 'Miho', 'Initials': 'M', 'LastName': 'Kusaka', 'Affiliation': 'Kusaka Clinic, Kure, Japan.'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Tsuchihashi', 'Affiliation': 'Steel Memorial Yawata Hospital, Kitakyushu, Japan.'}]",Hypertension research : official journal of the Japanese Society of Hypertension,['10.1038/s41440-020-0397-1']
3584,31361535,"Pemetrexed, Bevacizumab, or the Combination As Maintenance Therapy for Advanced Nonsquamous Non-Small-Cell Lung Cancer: ECOG-ACRIN 5508.","PURPOSE


Pemetrexed or bevacizumab is used for maintenance therapy of advanced nonsquamous non-small-cell lung cancer (NSCLC). The combination of bevacizumab and pemetrexed has also demonstrated efficacy. We conducted a randomized study to determine the optimal maintenance therapy.
PATIENTS AND METHODS


Patients with advanced nonsquamous NSCLC and no prior systemic therapy received carboplatin (area under the curve, 6), paclitaxel (200 mg/m 2 ), and bevacizumab (15 mg/kg) for up to four cycles. Patients without progression after four cycles were randomly assigned to maintenance therapy with bevacizumab (15 mg/kg), pemetrexed (500 mg/m 2 ), or a combination of the two agents. The primary end point was overall survival, with bevacizumab serving as the control group.
RESULTS


Of the 1,516 patients enrolled, 874 (57%) were randomly assigned after induction therapy to one of the three maintenance therapy groups. With a median follow-up of 50.6 months, median survival with pemetrexed was 15.9 months, compared with 14.4 months with bevacizumab (hazard ratio [HR], 0.86;  P  = .12); median survival with pemetrexed and bevacizumab was 16.4 months (HR, 0.9;  P  = .28); median progression-free survival was 4.2, 5.1 (HR, 0.85;  P  = .06), and 7.5 months (HR, 0.67;  P  < .001) for the three groups, respectively. Incidence of worst grade 3 to 4 toxicity was 29%, 37%, and 51%, respectively, for bevacizumab, pemetrexed, and the combination regimen.
CONCLUSION


Single-agent bevacizumab or pemetrexed is efficacious as maintenance therapy for advanced nonsquamous NSCLC. Because of a lack of survival benefit and higher toxicity, the combination of bevacizumab and pemetrexed cannot be recommended.",2019,"Incidence of worst grade 3 to 4 toxicity was 29%, 37%, and 51%, respectively, for bevacizumab, pemetrexed, and the combination regimen.
","['Patients with advanced nonsquamous NSCLC and no prior systemic therapy received', 'advanced nonsquamous NSCLC', 'Patients without progression after four cycles', 'Advanced Nonsquamous Non-Small-Cell Lung Cancer', '1,516 patients enrolled, 874 (57', 'advanced nonsquamous non-small-cell lung cancer (NSCLC']","['bevacizumab and pemetrexed', 'bevacizumab', 'pemetrexed', 'maintenance therapy with bevacizumab', 'Pemetrexed or bevacizumab', 'bevacizumab, pemetrexed', 'bevacizumab or pemetrexed', 'Pemetrexed, Bevacizumab, or the Combination', 'carboplatin (area under the curve, 6), paclitaxel']","['median survival', 'overall survival', ' median progression-free survival', 'survival benefit and higher toxicity', 'Incidence of worst grade 3 to 4 toxicity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0210657', 'cui_str': 'pemetrexed'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}]",1516.0,0.118515,"Incidence of worst grade 3 to 4 toxicity was 29%, 37%, and 51%, respectively, for bevacizumab, pemetrexed, and the combination regimen.
","[{'ForeName': 'Suresh S', 'Initials': 'SS', 'LastName': 'Ramalingam', 'Affiliation': 'Winship Cancer Institute of Emory University, Atlanta, GA.'}, {'ForeName': 'Suzanne E', 'Initials': 'SE', 'LastName': 'Dahlberg', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Chandra P', 'Initials': 'CP', 'LastName': 'Belani', 'Affiliation': 'Penn State Health Milton S. Hershey Medical Center, Hershey, PA.'}, {'ForeName': 'Joel N', 'Initials': 'JN', 'LastName': 'Saltzman', 'Affiliation': 'University Hospitals Seidman Cancer Center, Cleveland, OH.'}, {'ForeName': 'Nathan A', 'Initials': 'NA', 'LastName': 'Pennell', 'Affiliation': 'Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'Gopakumar S', 'Initials': 'GS', 'LastName': 'Nambudiri', 'Affiliation': ""St John's Hospital, Maplewood, MN.""}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'McCann', 'Affiliation': 'Baystate Health, Springfield, MA.'}, {'ForeName': 'Jerome D', 'Initials': 'JD', 'LastName': 'Winegarden', 'Affiliation': 'St Joseph Mercy Ann Arbor Hospital, Ann Arbor, MI.'}, {'ForeName': 'Mohammed A', 'Initials': 'MA', 'LastName': 'Kassem', 'Affiliation': 'Sinai Cancer Care and Infusion Center, Chicago, IL.'}, {'ForeName': 'Mohamed K', 'Initials': 'MK', 'LastName': 'Mohamed', 'Affiliation': 'Moses H. Cone Memorial Hospital, Greensboro, NC.'}, {'ForeName': 'Jan M', 'Initials': 'JM', 'LastName': 'Rothman', 'Affiliation': 'Hillman Cancer Center, University Pittsburgh Medical Center, Pittsburgh, PA.'}, {'ForeName': 'Alan P', 'Initials': 'AP', 'LastName': 'Lyss', 'Affiliation': 'Missouri Baptist Medical Center, St Louis, MO.'}, {'ForeName': 'Leora', 'Initials': 'L', 'LastName': 'Horn', 'Affiliation': 'Vanderbilt University, Nashville, TN.'}, {'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Stinchcombe', 'Affiliation': 'Duke University, Durham, NC.'}, {'ForeName': 'Joan H', 'Initials': 'JH', 'LastName': 'Schiller', 'Affiliation': 'Inova Schar Cancer Center, Fairfax, VA.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.01006']
3585,32036610,Mixed hemodiafiltration reduces erythropoiesis stimulating agents requirement in dialysis patients: a prospective randomized study.,"BACKGROUND


Improved responsiveness to erythropoiesis stimulating agents (ESAs) in patients on on-line post-dilution hemodiafiltration (Post-HDF) compared with conventional hemodialysis (HD) was reported by some authors but challenged by others. This prospective, cross-over randomized study tested the hypothesis that an alternative infusion modality of HDF, mixed-dilution HDF (Mixed HDF), could further reduce ESAs requirement in dialysis patients compared to the traditional Post-HDF.
METHODS


One-hundred-twenty prevalent patients from 6 Dialysis Centers were randomly assigned to two six-months treatment sequences: A-B and B-A (A, Mixed HDF; B, Post-HDF). Primary outcome was comparative evaluation of ESA (darbepoetin alfa) requirement and ESA resistance. Treatments efficiency, iron and vitamins status, inflammation and nutrition parameters were monitored.
RESULTS


In sequence A, darbepoetin requirement decreased during Mixed HDF from 29.5 to 23.7 µg/month and increased significantly during Post-HDF (32.3 µg/month at 6th month) while, in sequence B, it increased during Post-HDF from 38.2 to 43.7 µg/month and decreased during Mixed HDF (23.9 µg/month at 6th month). Overall, EPO doses at 6 months on Mixed and Post-HDF were 23.8 and 38.4 µg/month, respectively, P < 0.01. A multiple linear model confirmed that Mixed HDF vs Post-HDF reduced significantly ESA requirement and ESA resistance (P < 0.0001), by a mean of 29% (CI 23-35%) in the last three months of the observation periods.
CONCLUSIONS


Mixed HDF decreased darbepoetin-alfa requirement in dialysis patients. This might help preventing the untoward side effects of high ESA doses, besides having a remarkable economic impact. Additional evidence is needed to confirm this potential benefit of Mixed-HDF.",2020,"A multiple linear model confirmed that Mixed HDF vs Post-HDF reduced significantly ESA requirement and ESA resistance (P < 0.0001), by a mean of 29% (CI 23-35%) in the last three months of the observation periods.
","['dialysis patients', 'One-hundred-twenty prevalent patients from 6 Dialysis Centers']","['erythropoiesis stimulating agents (ESAs', 'conventional hemodialysis (HD', 'HDF, mixed-dilution HDF (Mixed HDF', 'Mixed hemodiafiltration']","['Treatments efficiency, iron and vitamins status, inflammation and nutrition parameters', 'darbepoetin-alfa requirement', 'darbepoetin requirement decreased during Mixed HDF', 'comparative evaluation of ESA (darbepoetin alfa) requirement and ESA resistance', 'ESA requirement and ESA resistance']","[{'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C1959590', 'cui_str': 'Erythropoiesis Stimulating Agents'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0079240', 'cui_str': 'Dilution Technics'}, {'cui': 'C1720722', 'cui_str': 'Mix'}, {'cui': 'C0206075', 'cui_str': 'Hemodiafiltration'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0042890', 'cui_str': 'Vitamins'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0937950', 'cui_str': 'darbepoetin alfa'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C3472649', 'cui_str': 'ESAS'}]",120.0,0.0169487,"A multiple linear model confirmed that Mixed HDF vs Post-HDF reduced significantly ESA requirement and ESA resistance (P < 0.0001), by a mean of 29% (CI 23-35%) in the last three months of the observation periods.
","[{'ForeName': 'Luciano A', 'Initials': 'LA', 'LastName': 'Pedrini', 'Affiliation': 'Nephrology and Dialysis Unit, NephroCare, ASST Bergamo-Est, Bolognini Hospital, Seriate, Italy. Luciano.pedrini@fmc-ag.com.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Comelli', 'Affiliation': 'Department of Brain and Behavioural Sciences, University of Pavia, Pavia, Italy.'}, {'ForeName': 'Pio', 'Initials': 'P', 'LastName': 'Ruggiero', 'Affiliation': 'Nephrology and Dialysis Unit, NephroCare, ASST Bergamo-Est, Bolognini Hospital, Seriate, Italy.'}, {'ForeName': 'Annalisa', 'Initials': 'A', 'LastName': 'Feliciani', 'Affiliation': 'Nephrology and Dialysis Unit, NephroCare, ASST Bergamo-Est, Bolognini Hospital, Seriate, Italy.'}, {'ForeName': 'Vania', 'Initials': 'V', 'LastName': 'Manfrini', 'Affiliation': 'Nephrology and Dialysis Unit, NephroCare, ASST Bergamo-Est, Bolognini Hospital, Seriate, Italy.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Cozzi', 'Affiliation': 'Nephrology and Dialysis Unit, NephroCare, ASST Bergamo-Est, Bolognini Hospital, Seriate, Italy.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Castellano', 'Affiliation': 'Nephrology and Dialysis Unit, NephroCare, ASST Bergamo-Est, Bolognini Hospital, Seriate, Italy.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Pezzotta', 'Affiliation': 'Nephrology and Dialysis Unit, NephroCare, ASST Bergamo-Est, Bolognini Hospital, Seriate, Italy.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Gatti', 'Affiliation': 'Nephrology and Dialysis Unit, NephroCare, ASST Bergamo-Est, Bolognini Hospital, Seriate, Italy.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Arazzi', 'Affiliation': 'Nephrology and Dialysis Unit, NephroCare, ASST Bergamo-Est, Bolognini Hospital, Seriate, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Auriemma', 'Affiliation': 'Biochemistry Unit, ASST Bergamo-Est, Bolognini Hospital, Seriate, Italy.'}, {'ForeName': 'Attilio', 'Initials': 'A', 'LastName': 'di Benedetto', 'Affiliation': 'Medical Coordination NephroCare, Naples, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Stuard', 'Affiliation': 'Fresenius Medical Care, Clinical and Therapeutical Governance, Bad Homburg, Germany.'}]",Journal of nephrology,['10.1007/s40620-020-00709-0']
3586,32039987,Surgical Prevention of Anastomotic Recurrence by Excluding Mesentery in Crohn's Disease: The SuPREMe-CD Study - A Randomized Clinical Trial.,"MINI: In this randomized clinical trial to prevent anastomotic recurrence in Crohn disease, the new Kono-S anastomosis demonstrates a significant reduction in postoperative clinical and endoscopic recurrence rates after ileocolic surgery than conventional side-to-side anastomosis and no safety issues.
OBJECTIVE


This trial aimed to provide randomized controlled data comparing Kono-S anastomosis and stapled ileocolic side-to-side anastomosis.
BACKGROUND


Recently, a new antimesenteric, functional, end-to-end, hand-sewn ileocolic anastomosis (Kono-S) has shown a significant reduction in endoscopic recurrence score and surgical recurrence rate in Crohn disease (CD).
METHODS


Randomized controlled trial (RCT) at a tertiary referral institution. Primary endpoint: endoscopic recurrence (ER) (Rutgeerts score ≥i2) after 6 months. Secondary endpoints: clinical recurrence (CR) after 12 and 24 months, ER after 18 months, and surgical recurrence (SR) after 24 months.
RESULTS


In all, 79 ileocolic CD patients were randomized in Kono group (36) and Conventional group (43). After 6 months, 22.2% in the Kono group and 62.8% in the Conventional group presented an ER [P < 0.001, odds ratio (OR) 5.91]. A severe postoperative ER (Rutgeerts score ≥i3) was found in 13.8% of Kono versus 34.8% of Conventional group patients (P = 0.03, OR 3.32). CR rate was 8% in the Kono group versus 18% in the Conventional group after 12 months (P = 0.2), and 18% versus 30.2% after 24 months (P = 0.04, OR 3.47). SR rate after 24 months was 0% in the Kono group versus 4.6% in the Conventional group (P = 0.3). Patients with Kono-S anastomosis presented a longer time until CR than patients with side-to-side anastomosis (hazard ratio 0.36, P = 0.037). On binary logistic regression analysis, the Kono-S anastomosis was the only variable significantly associated with a reduced risk of ER (OR 0.19, P < 0.001). There were no differences in postoperative outcomes.
CONCLUSIONS


This is the first RCT comparing Kono-S anastomosis and standard anastomosis in CD. The results demonstrate a significant reduction in postoperative endoscopic and clinical recurrence rate for patients who underwent Kono-S anastomosis, and no safety issues.ClinicalTrials.gov ID NCT02631967.",2020,"The results demonstrate a significant reduction in postoperative endoscopic and clinical recurrence rate for patients who underwent Kono-S anastomosis, and no safety issues.","[""Crohn's Disease"", '79 ileocolic CD patients']","['Kono-S anastomosis and stapled ileocolic side-to-side anastomosis', 'MINI']","['SR rate', 'longer time until CR', 'postoperative outcomes', 'postoperative endoscopic and clinical recurrence rate', 'CR rate', 'endoscopic recurrence (ER) ', 'postoperative clinical and endoscopic recurrence rates', 'severe postoperative ER', 'endoscopic recurrence score and surgical recurrence rate', 'clinical recurrence (CR', 'reduced risk of ER', 'surgical recurrence (SR']","[{'cui': 'C0156147', 'cui_str': 'Colitis, Granulomatous'}, {'cui': 'C0450203', 'cui_str': 'Ileocolic (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0332853', 'cui_str': 'Anastomosis (morphologic abnormality)'}, {'cui': 'C1293124', 'cui_str': 'Stapling procedure'}, {'cui': 'C0450203', 'cui_str': 'Ileocolic (qualifier value)'}, {'cui': 'C0677619', 'cui_str': 'Side-to-side anastomosis (qualifier value)'}, {'cui': 'C0445542', 'cui_str': 'Mini (qualifier value)'}]","[{'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",79.0,0.165843,"The results demonstrate a significant reduction in postoperative endoscopic and clinical recurrence rate for patients who underwent Kono-S anastomosis, and no safety issues.","[{'ForeName': 'Gaetano', 'Initials': 'G', 'LastName': 'Luglio', 'Affiliation': 'Surgery, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Rispo', 'Affiliation': 'Gastroenterology, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Imperatore', 'Affiliation': 'Gastroenterology, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Mariano Cesare', 'Initials': 'MC', 'LastName': 'Giglio', 'Affiliation': 'Surgery, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Amendola', 'Affiliation': 'Surgery, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Francesca Paola', 'Initials': 'FP', 'LastName': 'Tropeano', 'Affiliation': 'Surgery, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Peltrini', 'Affiliation': 'Surgery, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Fabiana', 'Initials': 'F', 'LastName': 'Castiglione', 'Affiliation': 'Gastroenterology, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Giovanni Domenico', 'Initials': 'GD', 'LastName': 'De Palma', 'Affiliation': 'Surgical Endoscopy, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Bucci', 'Affiliation': 'Surgery, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}]",Annals of surgery,['10.1097/SLA.0000000000003821']
3587,31919090,Prognostic and predictive role of gene mutations in chronic lymphocytic leukemia: results from the pivotal phase III study COMPLEMENT1.,"Next generation sequencing studies in Chronic lymphocytic leukemia (CLL) have revealed novel genetic variants that have been associated with disease characteristics and outcome. The aim of this study was to evaluate the prognostic value of recurrent molecular abnormalities in patients with CLL. Therefore, we assessed their incidences and associations with other clinical and genetic markers in the prospective multicenter COMPLEMENT1 trial (treatment naive patients not eligible for intensive treatment randomized to chlorambucil (CHL) vs. ofatumumab-CHL (O-CHL)). Baseline samples were available from 383 patients (85.6%) representative of the total trial cohort. Mutations were analyzed by amplicon-based targeted next generation sequencing (tNGS). In 52.2% of patients we found at least one mutation and the incidence was highest in NOTCH1 (17.0%), followed by SF3B1 (14.1%), ATM (11.7%), TP53 (10.2%), POT1 (7.0%), RPS15 (4.4%), FBXW7 (3.4%), MYD88 (2.6%) and BIRC3 (2.3%). While most mutations lacked prognostic significance, TP53 (HR2.02,p<0.01), SF3B1 (HR1.66,p=0.01) and NOTCH1 (HR1.39,p=0.03) were associated with inferior PFS in univariate analysis. Multivariate analysis confirmed the independent prognostic role of TP53 for PFS (HR1.71,p=0.04) and OS (HR2.78,p=0.02) and of SF3B1 for PFS only (HR1.52,p=0.02). Notably, NOTCH1 mutation status separates patients with a strong and a weak benefit from ofatumumab addition to CHL (NOTCH1wt:HR0.50,p<0.01, NOTCH1mut:HR0.81,p=0.45). In summary, TP53 and SF3B1 were confirmed as independent prognostic and NOTCH1 as a predictive factor for reduced ofatumumab efficacy in a randomized chemo (immune)therapy CLL trial. These results validate NGS-based mutation analysis in a multicenter trial and provide a basis for expanding molecular testing in the prognostic workup of patients with CLL. ClinicalTrials.gov registration number: NCT00748189.",2020,"Multivariate analysis confirmed the independent prognostic role of TP53 for PFS (HR1.71,p=0.04) and OS (HR2.78,p=0.02) and of SF3B1 for PFS only (HR1.52,p=0.02).","['383 patients (85.6%) representative of the total trial cohort', 'patients with CLL', 'naive patients not eligible for intensive treatment randomized to', 'Chronic lymphocytic leukemia (CLL', 'chronic lymphocytic leukemia']",['chlorambucil (CHL) vs. ofatumumab-CHL (O-CHL'],"['POT1', 'RPS15', 'FBXW7', 'TP53']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0023434', 'cui_str': 'Lymphoma, Small Lymphocytic'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0008163', 'cui_str': 'Chlorambucil'}, {'cui': 'C1832027', 'cui_str': 'ofatumumab'}]",[],383.0,0.156623,"Multivariate analysis confirmed the independent prognostic role of TP53 for PFS (HR1.71,p=0.04) and OS (HR2.78,p=0.02) and of SF3B1 for PFS only (HR1.52,p=0.02).","[{'ForeName': 'Eugen', 'Initials': 'E', 'LastName': 'Tausch', 'Affiliation': 'Department of Internal Medicine III, Ulm University, Ulm, Germany.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Beck', 'Affiliation': 'Department of Internal Medicine III, Ulm University, Ulm, Germany.'}, {'ForeName': 'Richard F', 'Initials': 'RF', 'LastName': 'Schlenk', 'Affiliation': 'Department of Internal Medicine III, Ulm University, Ulm, Germany.'}, {'ForeName': 'Billy J', 'Initials': 'BJ', 'LastName': 'Jebaraj', 'Affiliation': 'Department of Internal Medicine III, Ulm University, Ulm, Germany.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Dolnik', 'Affiliation': 'Klinik fur Innere Medizin fur Hematologie, Onkologie und Tumorimmunologie, Charité Berlin.'}, {'ForeName': 'Deyan Y', 'Initials': 'DY', 'LastName': 'Yosifov', 'Affiliation': 'Department of Internal Medicine III, Ulm University, Ulm, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hillmen', 'Affiliation': ""Department of Haematology, St. James's University Hospital, Leeds, United Kingdom.""}, {'ForeName': 'Fritz', 'Initials': 'F', 'LastName': 'Offner', 'Affiliation': 'Universitair Ziekenhuis Gent, Gent, Belgium.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Janssens', 'Affiliation': 'Universitair Ziekenhuis Leuven, Leuven, Belgium.'}, {'ForeName': 'K Govind', 'Initials': 'KG', 'LastName': 'Babu', 'Affiliation': 'Kidwai Memorial Institute of Oncology, Bangalore, India.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Grosicki', 'Affiliation': 'Hematology and Cancer Prevention,School of Public Health,Silesian Medical University,Katowice,Poland.'}, {'ForeName': 'Jiri', 'Initials': 'J', 'LastName': 'Mayer', 'Affiliation': 'Department of Haematology-Oncology, University Hospital Brno, Brno, Czech Republic.'}, {'ForeName': 'Panagiotis', 'Initials': 'P', 'LastName': 'Panagiotidis', 'Affiliation': 'University of Athens, Laikon General Hospital, Athens, Greece.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'McKeown', 'Affiliation': 'Oncology Global Medicines Development, AstraZeneca, Melbourn, UK.'}, {'ForeName': 'Ira V', 'Initials': 'IV', 'LastName': 'Gupta', 'Affiliation': 'GSK Oncology, GlaxoSmithKline, London, UK.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Skorupa', 'Affiliation': 'Novartis Pharma GmbH, Nürnberg, Germany.'}, {'ForeName': 'Celine', 'Initials': 'C', 'LastName': 'Pallaud', 'Affiliation': 'Novartis AG, Basel, Switzerland.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Bullinger', 'Affiliation': 'Klinik fur Innere Medizin fur Hematologie, Onkologie und Tumorimmunologie, Charité, Berlin.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Mertens', 'Affiliation': 'Department of Internal Medicine III, Ulm University, Ulm, Germany.'}, {'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Döhner', 'Affiliation': 'Department of Internal Medicine III, Ulm University, Ulm, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Stilgenbauer', 'Affiliation': 'Department of Internal Medicine III, Ulm University, Ulm, Germany; stephan.stilgenbauer@uniklinik-ulm.de.'}]",Haematologica,['10.3324/haematol.2019.229161']
3588,32036471,Cryotherapy for the prevention of weekly paclitaxel-induced peripheral adverse events in breast cancer patients.,"PURPOSE


This randomized phase II study was conducted to investigate the efficacy of cryotherapy in preventing peripheral neuropathy and dermatological adverse events in breast cancer patients treated with weekly paclitaxel.
METHODS


Patients treated with 12 weekly doses of paclitaxel for breast cancer were randomized (1:1) into a cryotherapy or control group. The primary endpoint was the percentage of patients with a marked decrease in the Functional Assessment of Cancer Therapy-Neurotoxicity (FACT-NTX) score. The secondary endpoints were Patient Neurotoxicity Questionnaire (PNQ), Common Terminology Criteria for Adverse Event (CTCAE) for peripheral neuropathy, and FACT-Taxane score.
RESULTS


Forty-four patients were randomly assigned to the cryotherapy (n = 22) or control groups (n = 22). The percentage of patients with a marked decrease in FACT-NTX scores was significantly lower in the cryotherapy group than in the control group (41 vs. 73%, p = 0.03). The incidence of CTCAE grade ≥ 2 sensory (p = 0.001) and motor peripheral neuropathy (p = 0.01), and PNQ grade D or higher for sensory peripheral neuropathy (p = 0.02), and decrease in the FACT-Taxane score (p = 0.02) were also significantly lower in the cryotherapy group than in the control group. There were no serious side effects associated with cryotherapy.
CONCLUSION


Cryotherapy is an effective approach for prevention of peripheral neuropathy and dermatological adverse events in breast cancer patients treated with weekly paclitaxel.",2020,"The percentage of patients with a marked decrease in FACT-NTX scores was significantly lower in the cryotherapy group than in the control group (41 vs. 73%, p = 0.03).","['breast cancer patients treated with weekly paclitaxel', 'Patients treated with 12 weekly doses of', 'for breast cancer', 'breast cancer patients treated with weekly', 'Forty-four patients', 'breast cancer patients']","['paclitaxel', 'cryotherapy or control group', 'Cryotherapy', 'cryotherapy']","['Functional Assessment of Cancer Therapy-Neurotoxicity', 'peripheral adverse events', 'incidence of CTCAE grade ≥\u20092 sensory', 'FACT-Taxane score', 'Patient Neurotoxicity Questionnaire (PNQ), Common Terminology Criteria for Adverse Event', 'PNQ grade D or higher for sensory peripheral neuropathy', 'motor peripheral neuropathy', 'FACT-NTX scores', 'peripheral neuropathy and dermatological adverse events']","[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4319568', 'cui_str': '44'}]","[{'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C4551716', 'cui_str': 'Cryotherapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0235032', 'cui_str': 'Neurotoxin Diseases'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0796419', 'cui_str': 'Taxanes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1516728', 'cui_str': 'CTCAE (Common Terminology Criteria for Adverse Events)'}, {'cui': 'C0441808', 'cui_str': 'Grade D (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0151313', 'cui_str': 'Sensory neuropathy (disorder)'}, {'cui': 'C0235025', 'cui_str': 'Neuritis, Motor'}, {'cui': 'C0031117', 'cui_str': 'PNS (Peripheral Nervous System) Diseases'}, {'cui': 'C0011625', 'cui_str': 'Agent, Dermatological'}]",44.0,0.0198073,"The percentage of patients with a marked decrease in FACT-NTX scores was significantly lower in the cryotherapy group than in the control group (41 vs. 73%, p = 0.03).","[{'ForeName': 'Hideo', 'Initials': 'H', 'LastName': 'Shigematsu', 'Affiliation': 'Department of Breast Surgery, National Hospital Organization Kure Medical Center and Chugoku Cancer Center, 3-1, Aoyama-cho, Kure City, Hiroshima, 737-0023, Japan. shigematu1330@yahoo.co.jp.'}, {'ForeName': 'Taizo', 'Initials': 'T', 'LastName': 'Hirata', 'Affiliation': 'Department of Medical Oncology, National Hospital Organization Kure Medical Center and Chugoku Cancer Center, Aoyama-cho, Kure City, Hiroshima, Japan.'}, {'ForeName': 'Mai', 'Initials': 'M', 'LastName': 'Nishina', 'Affiliation': 'Department of Breast Surgery, National Hospital Organization Kure Medical Center and Chugoku Cancer Center, 3-1, Aoyama-cho, Kure City, Hiroshima, 737-0023, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Yasui', 'Affiliation': 'Department of Breast Surgery, National Hospital Organization Kure Medical Center and Chugoku Cancer Center, 3-1, Aoyama-cho, Kure City, Hiroshima, 737-0023, Japan.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Ozaki', 'Affiliation': 'Department of Breast Surgery, National Hospital Organization Kure Medical Center and Chugoku Cancer Center, 3-1, Aoyama-cho, Kure City, Hiroshima, 737-0023, Japan.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-020-05345-9']
3589,32036479,The Physical Health Care Fidelity Scale: Psychometric Properties.,"Mental health programs need an instrument to monitor adherence to evidence-based physical health care for people with serious mental illness. The paper describes the Physical Health Care Fidelity Scale and study interrater reliability, frequency distribution, sensitivity to change and feasibility. Four fidelity assessments were conducted over 18 months at 13 sites randomized to implementation support for evidence-based physical health care. We found good to excellent interrater reliability, adequate sensitivity for change, good feasibility and wide variability in fidelity across sites after 18 months of implementation. Programs were more successful in establishing Policies stating physical health care standards than in implementing these Policies. The Physical Health Care Fidelity Scale measures and guides implementation of evidence-based physical health care reliably.Trial registration: ClinicalTrials.gov Identifier: NCT03271242.",2020,"We found good to excellent interrater reliability, adequate sensitivity for change, good feasibility and wide variability in fidelity across sites after 18 months of implementation.",['people with serious mental illness'],[],"['Physical Health Care Fidelity Scale and study interrater reliability, frequency distribution, sensitivity to change and feasibility']","[{'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}]",[],"[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0222045'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",,0.0236868,"We found good to excellent interrater reliability, adequate sensitivity for change, good feasibility and wide variability in fidelity across sites after 18 months of implementation.","[{'ForeName': 'Torleif', 'Initials': 'T', 'LastName': 'Ruud', 'Affiliation': 'Division of Mental Health Services, Akershus University Hospital, Lørenskog, Norway. torleif.ruud@medisin.uio.no.'}, {'ForeName': 'Tordis Sørensen', 'Initials': 'TS', 'LastName': 'Høifødt', 'Affiliation': 'University Hospital Northern Norway, Tromsø, Norway.'}, {'ForeName': 'Delia Cimpean', 'Initials': 'DC', 'LastName': 'Hendrick', 'Affiliation': 'WestBridge, Manchester, NH, USA.'}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Drake', 'Affiliation': 'Westat, Lebanon, NH, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Høye', 'Affiliation': 'University Hospital Northern Norway, Tromsø, Norway.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Landers', 'Affiliation': 'Duke University, Durham, NC, USA.'}, {'ForeName': 'Kristin S', 'Initials': 'KS', 'LastName': 'Heiervang', 'Affiliation': 'Division of Mental Health Services, Akershus University Hospital, Lørenskog, Norway.'}, {'ForeName': 'Gary R', 'Initials': 'GR', 'LastName': 'Bond', 'Affiliation': 'Westat, Lebanon, NH, USA.'}]",Administration and policy in mental health,['10.1007/s10488-020-01019-0']
3590,32044871,FORGOT CALCIUM? ADMISSION IONIZED-CALCIUM IN TWO CIVILIAN RANDOMIZED CONTROLLED TRIALS OF PRE-HOSPITAL PLASMA FOR TRAUMATIC HEMORRHAGIC SHOCK.,"BACKGROUND


Randomized clinical trials(RCTs) support the use of pre-hospital plasma in traumatic hemorrhagic shock, especially in long transports. The citrate added to plasma binds with calcium, yet most pre-hospital trauma protocols have no guidelines for calcium replacement. We reviewed the experience of two recent pre-hospital plasma RCTs regarding admission ionized-calcium (i-Ca) blood levels and its impact on survival. We hypothesized that pre-hospital plasma is associated with hypocalcemia, which in turn is associated with lower survival.
METHODS


We studied patients enrolled in two institutions participating in pre-hospital plasma RCTs (Control=Standard-of-care; Experimental=Plasma), with i-Ca collected prior to calcium supplementation. Adults with traumatic hemorrhagic shock(SBP≤70 mmHg or 71-90mmHg+HR≥108bpm) were eligible. We use generalized linear mixed models with random intercepts and Cox proportional hazards models with robust standard errors to account for clustered data by institution. Hypocalcemia was defined as i-Ca<1.0mmol/L.
RESULTS


Of 160 subjects(76% men), 48% received pre-hospital plasma, median age 40years(IQR:28-53), 71% suffered blunt trauma, median ISS=22(IQR:17-34). Pre-hospital plasma and control patients were similar regarding age, sex, ISS, blunt mechanism, and brain injury. Pre-hospital plasma recipients had significantly higher rates of hypocalcemia compared to controls (53% vs 36%, Adjusted Relative Risk, aRR=1.48; 95%CI: 1.03-2.12, p=0.03). Severe hypocalcemia was significantly associated with decreased survival(Adjusted Hazard Ratio:1.07;95%CI:1.02-1.13, p=0.01) and massive transfusion(aRR= 2.70;95%CI:1.13-6.46, p=0.03), after adjustment for confounders(randomization group, age, ISS, and shock index).
CONCLUSION


Pre-hospital plasma in civilian trauma is associated with hypocalcemia, which in turn predicts lower survival and massive transfusion. These data underscore the need for explicit calcium supplementation guidelines in pre-hospital hemotherapy.
LEVEL OF EVIDENCE


",2020,"hospital plasma recipients had significantly higher rates of hypocalcemia compared to controls (53% vs 36%, Adjusted Relative Risk, aRR=1.48; 95%CI: 1.03-2.12, p=0.03).","['Adults with traumatic hemorrhagic shock(SBP≤70 mmHg or 71-90mmHg+HR≥108bpm', 'Of 160 subjects(76% men), 48% received pre-hospital plasma, median age 40years(IQR:28-53), 71% suffered blunt trauma, median ISS=22(IQR:17-34', 'We studied patients enrolled in two institutions participating in pre-hospital plasma RCTs (Control=Standard-of-care; Experimental=Plasma), with i-Ca collected prior to calcium supplementation']",[],"['massive transfusion(aRR', 'Hypocalcemia', 'Severe hypocalcemia', 'rates of hypocalcemia']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332663', 'cui_str': 'Traumatic (qualifier value)'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic (qualifier value)'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0043253', 'cui_str': 'Injuries, Nonpenetrating'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C1096745', 'cui_str': 'Calcium supplement therapy (regime/therapy)'}]",[],"[{'cui': 'C0522501', 'cui_str': 'Massive (qualifier value)'}, {'cui': 'C0020598', 'cui_str': 'Hypocalcemia'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]",,0.275164,"hospital plasma recipients had significantly higher rates of hypocalcemia compared to controls (53% vs 36%, Adjusted Relative Risk, aRR=1.48; 95%CI: 1.03-2.12, p=0.03).","[{'ForeName': 'Hunter B', 'Initials': 'HB', 'LastName': 'Moore', 'Affiliation': 'University of Colorado.'}, {'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Tessmer', 'Affiliation': 'University of Pittsburgh.'}, {'ForeName': 'Ernest E', 'Initials': 'EE', 'LastName': 'Moore', 'Affiliation': 'University of Colorado.'}, {'ForeName': 'Jason L', 'Initials': 'JL', 'LastName': 'Sperry', 'Affiliation': 'University of Pittsburgh.'}, {'ForeName': 'Mitchell J', 'Initials': 'MJ', 'LastName': 'Cohen', 'Affiliation': 'University of Colorado.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Chapman', 'Affiliation': 'University of Colorado.'}, {'ForeName': 'Anthony E', 'Initials': 'AE', 'LastName': 'Pusateri', 'Affiliation': 'Combat Casualty Care Research Program, US Army Medical Research Materiel Command, Fort Detrick, Maryland.'}, {'ForeName': 'Francis X', 'Initials': 'FX', 'LastName': 'Guyette', 'Affiliation': 'University of Pittsburgh.'}, {'ForeName': 'Joshua B', 'Initials': 'JB', 'LastName': 'Brown', 'Affiliation': 'University of Pittsburgh.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Neal', 'Affiliation': 'University of Pittsburgh.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Zuckerbraun', 'Affiliation': 'University of Pittsburgh.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Sauaia', 'Affiliation': 'University of Colorado.'}]",The journal of trauma and acute care surgery,['10.1097/TA.0000000000002614']
3591,32044751,Effect of a WeChat-Based Intervention (Run4Love) on Depressive Symptoms Among People Living With HIV in China: A Randomized Controlled Trial.,"BACKGROUND


People living with HIV (PLWH) have high rates of depressive symptoms. However, only a few effective mental health interventions exist for this vulnerable population.
OBJECTIVE


The aim of this study was to assess the efficacy of a WeChat-based intervention, Run4Love, with a randomized controlled trial among 300 people living with HIV and depression (PLWHD) in China.
METHODS


We recruited PLWH from the HIV outpatient clinic in South China. Participants were screened based on the Center for Epidemiologic Studies-Depression (CES-D) scale. Those who scored 16 or higher were eligible to participate. A total of 300 eligible patients were enrolled. After obtaining informed consent from the participants, completion of a baseline survey, and collection of participants' hair samples for measuring cortisol, the participants were randomly assigned to an intervention or a control group in a 1:1 ratio. The intervention group received the Run4Love program, delivered via the popular social media app WeChat. Cognitive behavioral stress management courses and weekly reminders of exercise were delivered in a multimedia format. Participants' progress was monitored with timely and tailored feedback. The control group received usual care and a brochure on nutrition for PLWH. Data were collected at 3, 6, and 9 months. The primary outcome was depression, which was measured by a validated instrument.
RESULTS


Participants in the intervention and control groups were comparable at baseline; about 91.3% (139/150), 88.3% (132/150), and 86.7% (130/150) participants completed the 3-, 6-, and 9-month follow-ups, respectively. At the 3-month follow-up, a significant reduction in CES-D score was observed in the intervention group (from 23.9 to 17.7 vs from 24.3 to 23.8; mean difference=-5.77, 95% CI -7.82 to -3.71; P<.001; standard effect size d=0.66). The mean changes in CES-D score from baseline to the 6- and 9-month follow-ups between the two groups remained statistically significant. No adverse events were reported.
CONCLUSIONS


The WeChat-based mobile health (mHealth) intervention Run4Love significantly reduced depressive symptoms among PLWHD, and the effect was sustained. An app-based mHealth intervention could provide a feasible therapeutic option for many PLWHD in resource-limited settings. Further research is needed to assess generalizability and cost-effectiveness of this intervention.
TRIAL REGISTRATION


Chinese Clinical Trial Registry ChiCTR-IPR-17012606; http://www.chictr.org.cn/showproj.aspx?proj=21019 (Archived by WebCite at https://www.webcitation.org/78Bw2vouF).",2020,"At the 3-month follow-up, a significant reduction in CES-D score was observed in the intervention group (from 23.9 to 17.7 vs from 24.3 to 23.8; mean difference=-5.77, 95% CI -7.82 to -3.71; P<.001; standard effect size d=0.66).","['Those who scored 16 or higher were eligible to participate', 'People living with HIV (PLWH', '300 people living with HIV and depression (PLWHD) in China', 'We recruited PLWH from the HIV outpatient clinic in South China', 'People Living With HIV in China', 'Participants were screened based on the Center for Epidemiologic Studies-Depression (CES-D) scale', '300 eligible patients were enrolled']","['WeChat-Based Intervention (Run4Love', 'usual care and a brochure on nutrition for PLWH', 'WeChat-based intervention, Run4Love', 'Run4Love program, delivered via the popular social media app WeChat']","['mean changes in CES-D score', 'CES-D score', 'Depressive Symptoms', 'depressive symptoms', 'adverse events']","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C3179065', 'cui_str': 'Social Media'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",300.0,0.172717,"At the 3-month follow-up, a significant reduction in CES-D score was observed in the intervention group (from 23.9 to 17.7 vs from 24.3 to 23.8; mean difference=-5.77, 95% CI -7.82 to -3.71; P<.001; standard effect size d=0.66).","[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Y Alicia', 'Initials': 'YA', 'LastName': 'Hong', 'Affiliation': 'Department of Health Administration and Policy, College of Health and Human Services, George Mason University, Fairfax, VA, United States.'}, {'ForeName': 'Weiping', 'Initials': 'W', 'LastName': 'Cai', 'Affiliation': ""Department of Infectious Diseases, Guangzhou Number Eight People's Hospital, Guangzhou, China.""}, {'ForeName': 'Linghua', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': ""Department of Infectious Diseases, Guangzhou Number Eight People's Hospital, Guangzhou, China.""}, {'ForeName': 'Yuantao', 'Initials': 'Y', 'LastName': 'Hao', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Jiaying', 'Initials': 'J', 'LastName': 'Qiao', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Zhimeng', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Hanxi', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'National Center of AIDS/STD Control and Prevention, Beijing, China.'}, {'ForeName': 'Chengbo', 'Initials': 'C', 'LastName': 'Zeng', 'Affiliation': 'South Carolina SmartState Center of Healthcare Quality, Arnold School of Public Health, University of South Carolina, Columbia, SC, United States.'}, {'ForeName': 'Cong', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': ""Department of Infectious Diseases, Guangzhou Number Eight People's Hospital, Guangzhou, China.""}, {'ForeName': 'Yiran', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Mengting', 'Initials': 'M', 'LastName': 'Zhu', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Zeng', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Frank J', 'Initials': 'FJ', 'LastName': 'Penedo', 'Affiliation': 'Department of Psychology, University of Miami, Coral Gables, FL, United States.'}]",Journal of medical Internet research,['10.2196/16715']
3592,32019509,Group cognitive behavioural therapy (GCBT) versus treatment as usual (TAU) in the treatment of irritable bowel syndrome (IBS): a study protocol for a randomized controlled trial.,"BACKGROUND


Irritable bowel syndrome (IBS) is a common disease that affects the quality of life (QOL) and social functioning of sufferers. Visceral anxiety is currently considered a key factor in the onset and exacerbation of IBS, and cognitive-behavioural therapy (CBT) targeting visceral anxiety is thought to be effective. However, access to CBT is limited due to the lack of trained therapists, the substantial time required for therapy and the associated costs. Group CBT (GCBT) may solve some of these problems. We have therefore planned this trial to examine the efficacy of GCBT for IBS.
METHODS


The trial is a two-armed, parallel group, open label, stratified block randomized superiority trial. The study group will consist of 112 participants (aged 18-75 years) with IBS (Rome-III or IV criteria). Participants will be randomly allocated 1:1 to (i) the intervention group: ten-week GCBT plus treatment as usual (TAU) or (ii) the control group: waiting list (WL) plus TAU. The co-primary outcomes are the change in IBS severity or disease-specific quality of life from baseline to week 13 which is 1 month after the end of treatment. The efficacy of GCBT for IBS will be examined through mixed-effects repeated-measures analysis.
DISCUSSION


GCBT, if found effective, can address the issues of the shortage of therapists as well as the time required and the costs associated with individual CBT. Clinically, the findings will help make effective CBT programmes accessible to a large number of distressed IBS patients at lower costs. Theoretically, the results will clarify the relationship between IBS and psychological stress and will help elucidate the underlying mechanisms of IBS.
TRIAL REGISTRATION


UMIN, CTR-UMIN000031710. Registered on March 13, 2018.",2020,"Clinically, the findings will help make effective CBT programmes accessible to a large number of distressed IBS patients at lower costs.","['irritable bowel syndrome (IBS', '112 participants (aged 18-75\u2009years) with IBS (Rome-III or IV criteria']","['Group CBT (GCBT', 'Group cognitive behavioural therapy (GCBT) versus treatment as usual (TAU', 'GCBT', 'GCBT plus treatment as usual (TAU) or (ii) the control group: waiting list (WL) plus TAU']","['change in IBS severity or disease-specific quality of life', 'Visceral anxiety']","[{'cui': 'C0022104', 'cui_str': 'Irritable Bowel Syndrome'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1720655', 'cui_str': 'Tau'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0034380'}, {'cui': 'C0442045', 'cui_str': 'Visceral (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.0987733,"Clinically, the findings will help make effective CBT programmes accessible to a large number of distressed IBS patients at lower costs.","[{'ForeName': 'Shino', 'Initials': 'S', 'LastName': 'Kikuchi', 'Affiliation': 'Department of Gastroenterology and Hepatology, Kyoto University Graduate School of Medicine, 54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, Japan. shino_k@kuhp.kyoto-u.ac.jp.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Oe', 'Affiliation': 'National Center for Cognitive Behavior Therapy and Research, National Center of Neurology and Psychiatry, 4-1-1 Ogawa Higashi, Kodaira, Tokyo, Japan.'}, {'ForeName': 'Yohei', 'Initials': 'Y', 'LastName': 'Sasaki', 'Affiliation': 'National Center for Cognitive Behavior Therapy and Research, National Center of Neurology and Psychiatry, 4-1-1 Ogawa Higashi, Kodaira, Tokyo, Japan.'}, {'ForeName': 'Hirono', 'Initials': 'H', 'LastName': 'Ishii', 'Affiliation': 'National Center for Cognitive Behavior Therapy and Research, National Center of Neurology and Psychiatry, 4-1-1 Ogawa Higashi, Kodaira, Tokyo, Japan.'}, {'ForeName': 'Yuri', 'Initials': 'Y', 'LastName': 'Ito', 'Affiliation': 'Department of Computer Science, Tokyo University of Science, 6-3-1 Shinjyuku, Katuragi-ku, Tokyo, Japan.'}, {'ForeName': 'Masaru', 'Initials': 'M', 'LastName': 'Horikoshi', 'Affiliation': 'National Center for Cognitive Behavior Therapy and Research, National Center of Neurology and Psychiatry, 4-1-1 Ogawa Higashi, Kodaira, Tokyo, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Sozu', 'Affiliation': 'Kyoto University Hospital 54 Kawaharacho, Shogoin, Sakyo-ku, Kyoto, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Seno', 'Affiliation': 'Department of Gastroenterology and Hepatology, Kyoto University Graduate School of Medicine, 54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, Japan.'}, {'ForeName': 'Toshi A', 'Initials': 'TA', 'LastName': 'Furukawa', 'Affiliation': 'Department of Health Promotion and Human Behavior, Kyoto University Graduate School of Medicine / School of Public Health, Yoshida Konoe-cho, Sakyo-ku, Kyoto, Japan.'}]",BMC gastroenterology,['10.1186/s12876-020-1157-z']
3593,31930360,Effectiveness of Combined Behavioral and Drug Therapy for Overactive Bladder Symptoms in Men: A Randomized Clinical Trial.,"Importance


First-line behavioral and drug therapies for overactive bladder (OAB) symptoms in men are effective but not usually curative.
Objective


To determine whether combining behavioral and drug therapies improves outcomes compared with each therapy alone for OAB in men and to compare 3 sequences for implementing combined therapy.
Design, Setting, and Participants


In this 3-site, 2-stage, 3-arm randomized clinical trial, participants were randomized to 6 weeks of behavioral therapy alone, drug therapy alone, or combined therapy followed by step-up to 6 weeks of combined therapy for all groups. Participants were recruited from 3 outpatient clinics and included community-dwelling men 40 years or older with urinary urgency and 9 or more voids per 24 hours. Data were collected from July 2010 to July 2015 and analyzed from April 2016 to September 2019.
Interventions


Behavioral therapy consisted of pelvic floor muscle training with urge suppression strategies and delayed voiding. Drug therapy included an antimuscarinic (sustained-release tolterodine, 4 mg) plus an α-blocker (tamsulosin, 0.4 mg).
Main Outcomes and Measures


Seven-day bladder diaries completed before and after each 6-week treatment stage were used to calculate reduction in frequency of urination (primary outcome) and other symptoms (ie, urgency, urgency incontinence, and nocturia). Other secondary outcomes included validated patient global ratings of improvement and satisfaction, Overactive Bladder Questionnaire score, and International Prostate Symptom Score.
Results


Of the 204 included men, 133 (65.2%) were white, and the mean (SD) age was 64.1 (11.1) years. A total of 21 men discontinued treatment and 183 completed treatment. Mean (SD) voids per 24 hours decreased significantly in all 3 groups from baseline to 6-week follow-up (behavioral therapy: 11.7 [2.4] vs 8.8 [2.1]; change, 2.9 [2.4]; percentage change, 24.7%; P < .001; drug therapy: 11.8 [2.5] vs 10.3 [2.7]; change, 1.5 [2.3]; percentage change, 12.7%; P < .001; combined therapy: 11.8 [2.4] vs 8.2 [2.3]; change, 3.6 [2.1]; percentage change, 30.5%; P < .001). Intention-to-treat analyses indicated that posttreatment mean (SD) voiding frequencies were significantly lower in those receiving combined therapy compared with drug therapy alone (8.2 [2.3] vs 10.3 [2.7]; P < .001) but not significantly lower compared with those receiving behavioral therapy alone (8.2 [2.3] vs 8.8 [2.1]; P = .19) and were lower for behavioral therapy alone compared with drug therapy alone (8.8 [2.1] vs 10.3 [2.7]; P < .001). At 12-week follow-up, after all groups had received combined therapy, improvements in mean (SD) voids per 24 hours were also greatest for those receiving initial combined therapy compared with baseline (behavioral therapy: 11.7 [2.4] vs 8.0 [2.2]; change, 3.7 [2.3]; percentage change, 31.6%; P < .001; drug therapy: 11.8 [2.5] vs 8.6 [2.3]; change, 3.2 [2.5]; percentage change, 27.1%; P < .001; combined therapy: 11.8 [2.4] vs 8.0 [2.2]; change, 3.8 [2.1]; percentage change, 32.2%; P < .001), but there were no statistically significant group differences on primary or secondary measures.
Conclusions and Relevance


Combining behavioral and drug therapy yields greater improvements in OAB symptoms than drug therapy alone but not behavioral therapy alone. When using a stepped approach, it is reasonable to begin with behavioral therapy alone.
Trial Registration


ClinicalTrials.gov identifier: NCT01175382.",2020,P < .001) but not significantly lower compared with those receiving behavioral therapy alone (8.2 [2.3] vs 8.8 [2.1]; P = .19) and were lower for behavioral therapy alone compared with drug therapy alone (8.8 [2.1] vs 10.3 [2.7]; P < .001).,"['204 included men, 133 (65.2%) were white, and the mean (SD) age was 64.1 (11.1) years', 'Overactive Bladder Symptoms in Men', 'Data were collected from July 2010 to July 2015 and analyzed from April 2016 to September 2019', 'Participants were recruited from 3 outpatient clinics and included community-dwelling men 40 years or older with urinary urgency and 9 or more voids per 24 hours', '21 men discontinued treatment and 183 completed treatment']","['antimuscarinic (sustained-release tolterodine, 4 mg) plus an α-blocker (tamsulosin, 0.4 mg', 'behavioral therapy alone, drug therapy alone, or combined therapy followed by step-up to 6 weeks of combined therapy', 'Combined Behavioral and Drug Therapy', 'pelvic floor muscle training with urge suppression strategies and delayed voiding']","['Mean (SD) voids per 24 hours', 'mean (SD) voids', 'frequency of urination (primary outcome) and other symptoms (ie, urgency, urgency incontinence, and nocturia', 'OAB symptoms', 'validated patient global ratings of improvement and satisfaction, Overactive Bladder Questionnaire score, and International Prostate Symptom Score', 'posttreatment mean (SD) voiding frequencies', 'Main Outcomes and Measures\n\n\nSeven-day bladder diaries', 'overactive bladder (OAB) symptoms']","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0878773', 'cui_str': 'Overactive Bladder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0085606', 'cui_str': 'Urgent desire to urinate (finding)'}, {'cui': 'C0456696', 'cui_str': '/24h'}, {'cui': 'C1706472', 'cui_str': 'Discontinue - dosing instruction imperative'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4517615', 'cui_str': 'One hundred and eighty-three'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C4521482', 'cui_str': 'Antimuscarinic'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0388753', 'cui_str': 'tolterodine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0257343', 'cui_str': 'tamsulosin'}, {'cui': 'C4517457', 'cui_str': 'Zero point four'}, {'cui': 'C0004933', 'cui_str': 'Behavior Modification'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0033972', 'cui_str': 'Psychotherapy, Multiple'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0454366', 'cui_str': 'Step ups (regime/therapy)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456696', 'cui_str': '/24h'}, {'cui': 'C2584336', 'cui_str': 'Frequency of urination (observable entity)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0021167', 'cui_str': 'Incontinence (finding)'}, {'cui': 'C0028734', 'cui_str': 'Nycturia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0878773', 'cui_str': 'Overactive Bladder'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1998280', 'cui_str': 'International prostate symptom score (assessment scale)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0430970', 'cui_str': 'Urinary frequency volume chart (procedure)'}]",,0.0524237,P < .001) but not significantly lower compared with those receiving behavioral therapy alone (8.2 [2.3] vs 8.8 [2.1]; P = .19) and were lower for behavioral therapy alone compared with drug therapy alone (8.8 [2.1] vs 10.3 [2.7]; P < .001).,"[{'ForeName': 'Kathryn L', 'Initials': 'KL', 'LastName': 'Burgio', 'Affiliation': 'Division of Gerontology, Geriatrics, and Palliative Care, Department of Medicine, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Kraus', 'Affiliation': 'Department of Urology, University of Texas Health Science Center at San Antonio, San Antonio.'}, {'ForeName': 'Theodore M', 'Initials': 'TM', 'LastName': 'Johnson', 'Affiliation': 'Birmingham/Atlanta Geriatric Research, Education, and Clinical Center (GRECC), Department of Veterans Affairs, Atlanta, Georgia.'}, {'ForeName': 'Alayne D', 'Initials': 'AD', 'LastName': 'Markland', 'Affiliation': 'Division of Gerontology, Geriatrics, and Palliative Care, Department of Medicine, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Camille P', 'Initials': 'CP', 'LastName': 'Vaughan', 'Affiliation': 'Birmingham/Atlanta Geriatric Research, Education, and Clinical Center (GRECC), Department of Veterans Affairs, Atlanta, Georgia.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': 'Department of Biostatistics, School of Public Health, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'David T', 'Initials': 'DT', 'LastName': 'Redden', 'Affiliation': 'Department of Biostatistics, School of Public Health, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Patricia S', 'Initials': 'PS', 'LastName': 'Goode', 'Affiliation': 'Division of Gerontology, Geriatrics, and Palliative Care, Department of Medicine, University of Alabama at Birmingham, Birmingham.'}]",JAMA internal medicine,['10.1001/jamainternmed.2019.6398']
3594,30746642,Prompting Patients with Poorly Controlled Diabetes to Identify Visit Priorities Before Primary Care Visits: a Pragmatic Cluster Randomized Trial.,"BACKGROUND


Most patients with diabetes do not meet all evidence-based goals of care, and many patients report poor communication and lack of involvement in decision-making during primary care visits.
OBJECTIVE


To test the hypothesis that a ""Pre-Visit Prioritization"" secure email message could improve visit communication and glycemic control among patients with type 2 diabetes.
DESIGN


We conducted a pragmatic, provider-randomized, multi-site clinical trial from March 2015 to October 2016 across 30 primary care practices within Kaiser Permanente Northern California (KPNC), a large integrated care delivery system.
PARTICIPANTS


Eligible patients had at least 1 year of KPNC membership, type 2 diabetes with most recently measured hemoglobin A1c (HbA1c) > = 8.0%, and were registered users of the KPNC online patient portal.
INTERVENTIONS


Patients in the intervention arm, upon booking an appointment, received a secure email through the KPNC online portal with a link to the EHR allowing them to submit their top one or two priorities prior to the visit. Control patients received usual care.
MAIN MEASURES


Glycemic control; change in HbA1c 6 and 12 months after the initial visit; patient-reported outcomes related to patient-provider communication and patient care experiences.
KEY RESULTS


During the study period, 1276 patients had at least one eligible visit. In post-visit surveys (n = 457), more intervention arm patients reported preparing questions for their visit (72% vs 63%, p = 0.048) and being given treatment choices to consider (81% vs 73%, p = 0.041). Patients in both arms had similar reductions in HbA1c over the 12-month study period (0.56% ± 1.45%), with no significant differences between arms.
CONCLUSIONS


A ""light touch"" email-based pre-visit intervention resulted in improved measures of visit interaction but did not significantly improve glycemic control relative to usual care. Improving diabetes clinical outcomes through more effective primary care visits may require more intensive approaches to patient visit preparation.
TRIAL REGISTRY


NCT02375932.",2019,"CONCLUSIONS


A ""light touch"" email-based pre-visit intervention resulted in improved measures of visit interaction but did not significantly improve glycemic control relative to usual care.","['patients with diabetes', '1276 patients had at least one eligible visit', 'Eligible patients had at least 1\xa0year of KPNC membership, type 2 diabetes with most recently measured hemoglobin A1c (HbA1c)\u2009>\u2009=\u20098.0%, and were registered users of the KPNC online patient portal', 'March 2015 to October 2016 across 30 primary care practices within Kaiser Permanente Northern California (KPNC), a large integrated care delivery system', 'patients with type 2 diabetes', 'Patients with Poorly Controlled Diabetes to Identify Visit Priorities']","['secure email through the KPNC online portal with a link to the EHR', 'usual care']","['visit communication and glycemic control', 'patient-provider communication and patient care experiences']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0439091', 'cui_str': '>='}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C4277550', 'cui_str': 'Patient Internet Portals'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0449914', 'cui_str': 'Delivery system (attribute)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0549179', 'cui_str': 'Priority (attribute)'}]","[{'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0205054', 'cui_str': 'Portal (qualifier value)'}]","[{'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0017313'}]",,0.111043,"CONCLUSIONS


A ""light touch"" email-based pre-visit intervention resulted in improved measures of visit interaction but did not significantly improve glycemic control relative to usual care.","[{'ForeName': 'Michelle T', 'Initials': 'MT', 'LastName': 'Vo', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, 2000 Broadway, Oakland, CA, 94612, USA.'}, {'ForeName': 'Connie S', 'Initials': 'CS', 'LastName': 'Uratsu', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, 2000 Broadway, Oakland, CA, 94612, USA.'}, {'ForeName': 'Karen R', 'Initials': 'KR', 'LastName': 'Estacio', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, 2000 Broadway, Oakland, CA, 94612, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Altschuler', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, 2000 Broadway, Oakland, CA, 94612, USA.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Kim', 'Affiliation': 'Department of Medicine, Oakland Medical Center, Kaiser Permanente Northern California, Oakland, CA, USA.'}, {'ForeName': 'Stacey E', 'Initials': 'SE', 'LastName': 'Alexeeff', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, 2000 Broadway, Oakland, CA, 94612, USA.'}, {'ForeName': 'Alyce S', 'Initials': 'AS', 'LastName': 'Adams', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, 2000 Broadway, Oakland, CA, 94612, USA.'}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Schmittdiel', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, 2000 Broadway, Oakland, CA, 94612, USA.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Heisler', 'Affiliation': 'Department of Internal Medicine, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Richard W', 'Initials': 'RW', 'LastName': 'Grant', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, 2000 Broadway, Oakland, CA, 94612, USA. Richard.W.Grant@KP.org.'}]",Journal of general internal medicine,['10.1007/s11606-018-4756-4']
3595,32044831,Efficacy and Safety of Carbon Dioxide Versus Air Insufflation for Colonoscopy in Deeply Sedated Pediatric Patients.,"OBJECTIVES


Studies have shown the advantages of carbon dioxide (CO2) over air insufflation in the adult population during colonoscopies. This study was designed to investigate the efficacy and safety of CO2 insufflation in deeply sedated children undergoing colonoscopy.
METHODS


This was a prospective, randomized, double-blind clinical trial. We recruited 100 consecutive pediatric patients who had colonoscopy under deep sedation for various indications. Patients were first randomized by history of abdominal pain and then randomly assigned to either CO2 or air insufflation. Postprocedural abdominal pain scores were registered on a 10-point visual analog rating scale and significant pain was defined as a score of 3 or higher. Abdominal circumferences and end tidal CO2 (ETCO2) levels were measured. Complications during and after the procedure were recorded.
RESULTS


We did not find statistically significant difference between CO2 and air insufflation on univariate analysis because of low number of children experiencing significant pain after colonoscopy. After adjusting for baseline pain, we found that pain was significantly lower in patients after CO2 versus air insufflation on multivariable analysis (P = 0.03). The significant factors related to pain were duration of the procedure (P = 0.006), history of abdominal pain (P = 0.002) and previous abdominal surgery (P = 0.02). CO2 insufflation was associated with decreased abdominal circumference after colonoscopy (P = 0.002). Girls were more likely to have pain regardless of intervention (P = .04).
CONCLUSIONS


Most children tolerate endoscopic procedures without significant pain. Our study was underpowered to show significant difference between air and CO2 on univariate analysis. CO2 insufflation during colonoscopy, however, may reduce postprocedural abdominal pain. Significant factors for increased pain on multivariate analysis included colonoscopy length over 30 minutes, history of abdominal pain, and previous abdominal surgery.",2020,We did not find statistically significant difference between CO2 and Air insufflation on univariate analysis due to low number of children experiencing significant pain after colonoscopy.,"['100 consecutive pediatric patients who had colonoscopy under deep sedation for various indications', 'adult population during colonoscopies', 'deeply sedated children undergoing colonoscopy', 'Deeply Sedated Pediatric Patients']","['Carbon Dioxide Versus Air Insufflation', 'CO2 insufflation', 'carbon dioxide (CO2', 'CO2 or air insufflation']","['Post-procedural abdominal pain scores', '10-point visual analog rating scale and significant pain', 'colonoscopy length over 30\u200amin, history of abdominal pain and previous abdominal surgery', 'efficacy and safety', 'history of abdominal pain', 'Efficacy and Safety', 'abdominal circumference', 'previous abdominal surgery', 'pain', 'CO2 insufflation', 'Abdominal circumferences and end tidal CO2 (ETCO2) levels']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C1956064', 'cui_str': 'Deep Sedation'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C4554317', 'cui_str': 'Deeply - dosing instruction fragment (qualifier value)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0021634', 'cui_str': 'Insufflation'}, {'cui': 'C1143776', 'cui_str': 'cobalt(II) bis(2,2,6,6-tetramethylheptane-3,5-dionate)'}]","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0000737', 'cui_str': 'Abdominal Pain'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1300813', 'cui_str': 'Abdominal circumference (observable entity)'}, {'cui': 'C1143776', 'cui_str': 'cobalt(II) bis(2,2,6,6-tetramethylheptane-3,5-dionate)'}, {'cui': 'C0021634', 'cui_str': 'Insufflation'}, {'cui': 'C3267130', 'cui_str': 'End-tidal CO2'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",100.0,0.310231,We did not find statistically significant difference between CO2 and Air insufflation on univariate analysis due to low number of children experiencing significant pain after colonoscopy.,"[{'ForeName': 'Rajmohan', 'Initials': 'R', 'LastName': 'Dharmaraj', 'Affiliation': 'Division of Gastroenterology, University of New Mexico, Carrie Tingley Hospital, Albuquerque, NM.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Dunn', 'Affiliation': ""Division of Department of Gastroenterology, Peyton Manning Children's Hospital, Indianapolis, IN.""}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Fritz', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, Department of Pediatrics, Maine Medical Center, Portland, ME.'}, {'ForeName': 'Mahua', 'Initials': 'M', 'LastName': 'Dasgupta', 'Affiliation': 'Division of Quantitative Health Sciences, Department of Pediatrics, Medical College of Wisconsin, Milwaukee, WI.'}, {'ForeName': 'Pippa', 'Initials': 'P', 'LastName': 'Simpson', 'Affiliation': 'Division of Quantitative Health Sciences, Department of Pediatrics, Medical College of Wisconsin, Milwaukee, WI.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Cabrera', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, Department of Pediatrics, Medical College of Wisconsin, Milwaukee, WI.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Miranda', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, Department of Pediatrics, Medical College of Wisconsin, Milwaukee, WI.'}, {'ForeName': 'Diana G', 'Initials': 'DG', 'LastName': 'Lerner', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, Department of Pediatrics, Medical College of Wisconsin, Milwaukee, WI.'}]",Journal of pediatric gastroenterology and nutrition,['10.1097/MPG.0000000000002650']
3596,32034285,Response-adapted lenalidomide maintenance in newly diagnosed myeloma: results from the phase III GMMG-MM5 trial.,"The MM5 trial aimed at demonstrating a progression-free survival (PFS) difference in continued vs. response-adapted (in case of complete response, CR) lenalidomide (LEN) maintenance therapy (MT) in newly diagnosed, transplant-eligible multiple myeloma (MM). Patients were equally randomized to receive induction therapy with PAd (bortezomib/doxorubicin/dexamethasone) or VCD (bortezomib/cyclophosphamide/dexamethasone), high-dose melphalan and autologous blood stem cell transplantation, and LEN consolidation, followed by either LEN MT for a fixed duration of 2 years (LEN-2Y) or until achievement of CR (LEN-CR, intention-to-treat population n = 502): arms A1:PAd + LEN-2Y (n = 125), B1:PAd + LEN-CR (n = 126), A2:VCD + LEN-2Y (n = 126), B2:VCD + LEN-CR (n = 125). In the LEN-CR group (B1 + B2), n = 88/17.5% patients did not start or discontinued LEN MT due to CR. There was no PFS (p = 0.60, primary endpoint) nor overall survival (OS) (p = 0.15) difference between the four study arms. On pooled LEN MT strategies, OS (hazard ratio, hazard ratio [HR] = 1.42, p = 0.03) but not PFS (HR = 1.15, p = 0.20) was shorter in LEN-CR (B1 + B2) vs. LEN-2Y (A1 + A2) groups. PFS was shortened on landmark analyses from the start of LEN MT in patients being in CR in the LEN-CR group (LEN-CR vs. LEN-2Y, HR = 1.84, p = 0.02). OS from first progression was shortened in the LEN-CR vs. LEN-2Y group (HR = 1.60, p = 0.01). LEN MT should be applied beyond CR for at least 2 years.",2020,"There was no PFS (p = 0.60, primary endpoint) nor overall survival (OS) (p = 0.15) difference between the four study arms.","['newly diagnosed myeloma', 'newly diagnosed, transplant-eligible multiple myeloma (MM']","['Response-adapted lenalidomide maintenance', 'CR) lenalidomide (LEN) maintenance therapy (MT', 'induction therapy with PAd (bortezomib/doxorubicin/dexamethasone) or VCD (bortezomib/cyclophosphamide/dexamethasone), high-dose melphalan and autologous blood stem cell transplantation, and LEN consolidation, followed by either LEN MT for a fixed duration of 2 years (LEN-2Y) or until achievement of CR (LEN-CR, intention-to-treat population n\u2009=\u2009502): arms A1:PAd\u2009+\u2009LEN-2Y (n\u2009=\u2009125), B1:PAd\u2009+\u2009LEN-CR (n\u2009=\u2009126), A2:VCD\u2009+\u2009LEN-2Y (n\u2009=\u2009126), B2:VCD\u2009+\u2009LEN-CR']","['PFS', 'overall survival (OS']","[{'cui': 'C0026764', 'cui_str': 'Myelomatosis'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}]","[{'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0441601', 'cui_str': 'Padding (qualifier value)'}, {'cui': 'C1176309', 'cui_str': 'bortezomib'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0025241', 'cui_str': 'Melphalan'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C1504389', 'cui_str': 'Stem Cell Transplantation'}, {'cui': 'C0702116', 'cui_str': 'Consolidation (morphologic abnormality)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C4319551', 'cui_str': 'One hundred and twenty-five'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.0511233,"There was no PFS (p = 0.60, primary endpoint) nor overall survival (OS) (p = 0.15) difference between the four study arms.","[{'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Goldschmidt', 'Affiliation': 'Department of Internal Medicine V, University Hospital Heidelberg, Heidelberg, Germany. hartmut.goldschmidt@med.uni-heidelberg.de.'}, {'ForeName': 'Elias K', 'Initials': 'EK', 'LastName': 'Mai', 'Affiliation': 'Department of Internal Medicine V, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Dürig', 'Affiliation': 'Department of Hematology, University Hospital Essen, Essen, Germany.'}, {'ForeName': 'Christof', 'Initials': 'C', 'LastName': 'Scheid', 'Affiliation': 'Department of Internal Medicine I, University Hospital Cologne, Cologne, Germany.'}, {'ForeName': 'Katja C', 'Initials': 'KC', 'LastName': 'Weisel', 'Affiliation': 'Department of Hematology, Oncology and Immunology, University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Kunz', 'Affiliation': 'Division of Biostatistics, German Cancer Research Center (DKFZ), Heidelberg, Germany.'}, {'ForeName': 'Uta', 'Initials': 'U', 'LastName': 'Bertsch', 'Affiliation': 'Department of Internal Medicine V, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hielscher', 'Affiliation': 'Division of Biostatistics, German Cancer Research Center (DKFZ), Heidelberg, Germany.'}, {'ForeName': 'Maximilian', 'Initials': 'M', 'LastName': 'Merz', 'Affiliation': 'Department of Internal Medicine V, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Munder', 'Affiliation': 'Department of Internal Medicine III, University Medical Center Mainz, Mainz, Germany.'}, {'ForeName': 'Hans-Walter', 'Initials': 'HW', 'LastName': 'Lindemann', 'Affiliation': 'Department of Hematology and Oncology, Katholisches Krankenhaus Hagen, Hagen, Germany.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Hügle-Dörr', 'Affiliation': 'Department of Internal Medicine V, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Tichy', 'Affiliation': 'Division of Biostatistics, German Cancer Research Center (DKFZ), Heidelberg, Germany.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Giesen', 'Affiliation': 'Department of Internal Medicine V, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Hose', 'Affiliation': 'Department of Internal Medicine V, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Seckinger', 'Affiliation': 'Department of Internal Medicine V, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Huhn', 'Affiliation': 'Department of Internal Medicine V, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Luntz', 'Affiliation': 'Coordination Centre for Clinical Trials (KKS), Heidelberg, Germany.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Jauch', 'Affiliation': 'Institute of Human Genetics, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Elmaagacli', 'Affiliation': 'Department of Hematology and Oncology, Asklepios Hospital Hamburg St. Georg, Hamburg, Germany.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Rabold', 'Affiliation': 'Coordination Centre for Clinical Trials (KKS), Heidelberg, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Fuhrmann', 'Affiliation': 'Department of Hematology and Oncology, Helios Hospital Berlin Buch, Berlin, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Brossart', 'Affiliation': 'University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Goerner', 'Affiliation': 'Department of Hematology, Oncology and Palliative Care, Klinikum Bielefeld, Bielefeld, Germany.'}, {'ForeName': 'Helga', 'Initials': 'H', 'LastName': 'Bernhard', 'Affiliation': 'Internal Medicine V, Klinikum Darmstadt, Darmstadt, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Hoffmann', 'Affiliation': 'Medical Clinic A, Klinikum Ludwigshafen, Ludwigshafen, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Hillengass', 'Affiliation': 'Department of Internal Medicine V, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Raab', 'Affiliation': 'Department of Internal Medicine V, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Igor W', 'Initials': 'IW', 'LastName': 'Blau', 'Affiliation': 'Medical Clinic, Charité University Medicine Berlin, Berlin, Germany.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Hänel', 'Affiliation': 'Department of Internal Medicine III, Klinikum Chemnitz, Chemnitz, Germany.'}, {'ForeName': 'Hans J', 'Initials': 'HJ', 'LastName': 'Salwender', 'Affiliation': 'Department of Hematology and Oncology, Asklepios Hospital Hamburg Altona, Hamburg, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Leukemia,['10.1038/s41375-020-0724-1']
3597,32032804,Charlie Chaplin and gesture training in severe aphasia: A controlled double-blind single-case experimental design.,"BACKGROUND


Aphasia following a stroke is a frequent and disabling condition that decreases quality of life. The use of gesture has been proposed as a way to enhance aphasia recovery.
OBJECTIVE


We aimed to explore whether 2 types of gesture interventions could improve communication in individuals with severe aphasia.
METHODS


This was a pilot study performed at home in routine care by an outreach team. The study had a controlled double-blind single-case experimental design (SCED): a controlled multiple baseline design across 3 participants and 2 behaviors (gesture and naming). Three male patients with stroke-induced severe chronic aphasia, non-functional perseverative speech and severe associated impairments underwent a passive gesture intervention, in which participants watched movies selected for their intensive use of gesture, and an active gesture intervention, in which they actively practiced gestures by using visual action therapy. The main outcome measures were naming score, gesture score and nonverbal subscale score of the Lillois Test of Communication, with 3-month follow-up.
RESULTS


In all 3 participants, gesture interventions improved the ability to gesture a list of words (Tau-U=0.38-0.67 for combined gesture intervention effect) and increased nonverbal communication activity. Benefits were maintained at 3-month follow-up.
CONCLUSIONS


Mute films that use intensive nonverbal communication may be a useful add-on to speech therapy for individuals with aphasia. Improving naming in severe and chronic aphasia may not be feasible, and more effort could be devoted to improving gesture-based and nonverbal communication.",2020,"In all 3 participants, gesture interventions improved the ability to gesture a list of words (Tau-U = 0.38-0.67 for combined gesture intervention effect) and increased non-verbal communication activity.","['individuals with severe aphasia', 'individuals with aphasia', '3 participants and 2 behaviors (gesture and naming', 'severe aphasia', 'Three male patients with stroke-induced severe chronic aphasia, non-functional perseverative speech and severe associated impairments underwent a']","['passive gesture intervention', 'gesture interventions', 'Charlie Chaplin and gesture training', 'participants watched movies selected for their intensive use of gesture, and an active gesture intervention, in which they actively practiced gestures by using Visual Action Therapy']","['non-verbal communication activity', 'ability to gesture a list of words', 'naming score, gesture score and non-verbal subscale score of the Lillois Test of Communication, with 3-month follow-up']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0003537', 'cui_str': 'Anepia'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0017510', 'cui_str': 'Gestures'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0205300', 'cui_str': 'Non-functional (qualifier value)'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}]","[{'cui': 'C0017510', 'cui_str': 'Gestures'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0681495', 'cui_str': 'Movies'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0730452', 'cui_str': 'Action therapy (regime/therapy)'}]","[{'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0017510', 'cui_str': 'Gestures'}, {'cui': 'C4522128', 'cui_str': 'Name (property)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0459443', 'cui_str': 'Subscale score (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]",3.0,0.289091,"In all 3 participants, gesture interventions improved the ability to gesture a list of words (Tau-U = 0.38-0.67 for combined gesture intervention effect) and increased non-verbal communication activity.","[{'ForeName': 'Clemence', 'Initials': 'C', 'LastName': 'Vibrac', 'Affiliation': ""Pôle Ambroise-Paré, service d'ORL, Hôpitaux civils de Colmar, 39, avenue de la Liberté, 68024 Colmar cedex, France; Pôle psychiatrie, service de psychiatrie infanto juvénile, Hôpitaux civils de Colmar, 39, avenue de la Liberté, 68024 Colmar cedex, France; Centre de formation universitaire en orthophonie de Strasbourg, 4, rue Kirschleger, 67000 Strasbourg, France.""}, {'ForeName': 'Amelie', 'Initials': 'A', 'LastName': 'Avias', 'Affiliation': 'Centre de formation universitaire en orthophonie de Strasbourg, 4, rue Kirschleger, 67000 Strasbourg, France.'}, {'ForeName': 'Pierre-Olivier', 'Initials': 'PO', 'LastName': 'François', 'Affiliation': 'Pôle de médecine physique et de réadaptation, Institut Universitaire de réadaptation Clemenceau-Strasbourg, 45, boulevard Clémenceau, 67082 Strasbourg cedex, France.'}, {'ForeName': 'Marie-Eve', 'Initials': 'ME', 'LastName': 'Isner-Horobeti', 'Affiliation': 'Pôle de médecine physique et de réadaptation, Institut Universitaire de réadaptation Clemenceau-Strasbourg, 45, boulevard Clémenceau, 67082 Strasbourg cedex, France; Strasbourg university, Fédération de médecine translationnelle de Strasbourg, EA 3072 ""mitochondrie, stress oxydant et protection musculaire"", Strasbourg, France.'}, {'ForeName': 'Agata', 'Initials': 'A', 'LastName': 'Krasny-Pacini', 'Affiliation': ""Pôle de médecine physique et de réadaptation, Institut Universitaire de réadaptation Clemenceau-Strasbourg, 45, boulevard Clémenceau, 67082 Strasbourg cedex, France; Strasbourg university, unité Inserm 1114 Neuropsychologie cognitive et physiopathologie de la schizophrénie, département de psychiatrie, Hôpital civil de Strasbourg, 1, place de l'Hôpital, 67091 Strasbourg cedex, France. Electronic address: agatakrasnypacini@gmail.com.""}]",Annals of physical and rehabilitation medicine,['10.1016/j.rehab.2019.12.010']
3598,32030694,Effects of suprascapular and axillary nerve block on postoperative pain relief sevoflurane consumption and visual clarity in arthroscopic shoulder surgery.,"OBJECTIVES


This study aims to investigate the effects of suprascapular nerve and axillary nerve block on postoperative pain, tramadol consumption, sevoflurane consumption and visual clarity of the surgical field in arthroscopic shoulder surgery.
METHODS


Forty-six patients undergoing arthroscopic shoulder surgery were randomized to receive either both suprascapular and axillary nerve block with ultrasound guidance (20 ml 0.25% bupivacaine) before general anesthesia (group SSAXB, n=23) or a subacromial local infiltration (20 ml 0.25% bupivacaine) after the procedure (group control, n=23). End-tidal sevoflurane consumption, visualization of the arthroscopic field scores of the patients were recorded during the procedure. The patient's postoperative pain scores (at PACU, 4, 8, 12, 24 hours after the surgery) and tramadol consumption were also recorded.
RESULTS


End-tidal sevoflurane concentration values were similar in both groups (p>0.05). Group SSAXB had a better mean static pain score in the PACU (Group SSAXB 4.27±1.48 vs Group C 6.24±1.09 p<0.05). Tramadol consumption was lower in group SSAXB than in group C (253.1±85.3 mg vs 324.2±72 mg, p=0.005). Visual clarity scores of the arthroscopic field were higher in group SSAXB than in group C along the intraoperative period (p<0.05).
CONCLUSION


SSAXB are effective in postoperative analgesia, reduce tramadol consumption and provide a clean image in the arthroscopic area of arthroscopic shoulder surgery, but these blocks do not reduce sevoflurane consumption.",2020,"Visual clarity scores of the arthroscopic field were higher in group SSAXB than in group C along the intraoperative period (p<0.05).
","['Forty-six patients undergoing arthroscopic shoulder surgery', 'arthroscopic shoulder surgery']","['suprascapular and axillary nerve block with ultrasound guidance (20 ml 0.25% bupivacaine', 'subacromial local infiltration (20 ml 0.25% bupivacaine', 'suprascapular and axillary nerve block', 'suprascapular nerve and axillary nerve block', 'PACU', 'SSAXB']","['postoperative pain relief sevoflurane consumption and visual clarity', 'tidal sevoflurane concentration values', 'postoperative pain scores', 'End-tidal sevoflurane consumption, visualization of the arthroscopic field scores', 'Visual clarity scores', 'mean static pain score', 'Tramadol consumption', 'tramadol consumption', 'postoperative pain, tramadol consumption, sevoflurane consumption and visual clarity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0860482', 'cui_str': 'Axillary nerve block'}, {'cui': 'C0442973', 'cui_str': 'Ultrasonic guidance procedure (procedure)'}, {'cui': 'C4517443', 'cui_str': '0.25 (qualifier value)'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C3669041', 'cui_str': 'Spread by direct extension (qualifier value)'}, {'cui': 'C0228878', 'cui_str': 'Structure of suprascapular nerve'}, {'cui': 'C0034871', 'cui_str': 'Hospital Recovery Rooms'}]","[{'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0486588', 'cui_str': 'Clarity (property) (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0440042', 'cui_str': ""Field's""}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}]",46.0,0.179778,"Visual clarity scores of the arthroscopic field were higher in group SSAXB than in group C along the intraoperative period (p<0.05).
","[{'ForeName': 'Derya', 'Initials': 'D', 'LastName': 'Özkan', 'Affiliation': 'Department of Anesthesiology and Reanimation, University of Health Sciences Diskapi Yildirim Beyazit Training and Research Hospital, Ankara, Turkey.'}, {'ForeName': 'Sevtap', 'Initials': 'S', 'LastName': 'Cemaloğlu', 'Affiliation': 'Department of Anesthesiology and Reanimation, University of Health Sciences Diskapi Yildirim Beyazit Training and Research Hospital, Ankara, Turkey.'}, {'ForeName': 'Faruk Mehmet', 'Initials': 'FM', 'LastName': 'Catma', 'Affiliation': 'Department of Orthopedics and Traumatology, University of Health Sciences Diskapi Yildirim Beyazit Training and Research Hospital, Ankara, Turkey.'}, {'ForeName': 'Taylan', 'Initials': 'T', 'LastName': 'Akkaya', 'Affiliation': 'Department of Anesthesiology and Reanimation, University of Health Sciences Diskapi Yildirim Beyazit Training and Research Hospital, Ankara, Turkey.'}]",Agri : Agri (Algoloji) Dernegi'nin Yayin organidir = The journal of the Turkish Society of Algology,['10.14744/agri.2019.04875']
3599,32030699,[Labor analgesia: Comparison of epidural patient-controlled analgesia and intravenous patient-controlled analgesia].,"OBJECTIVES


In our study, patient controlled epidural analgesia (PCEA) and patient controlled intravenous remifentanil analgesia (PCIVA) were compared for VAS, and also their side effects on mother and newborn.
METHODS


In this study, 37 pregnant women with a single fetus, who had labor analgesia, were divided into groups of PCIVA (Group 2) and PCEA (Group 1). Bupivacaine 1.25 mg/ml and fentanyl 2 mcg/ml in 100 ml epidural solution were prepared for Group 1. The infusion dose was 15 ml, 5 ml divided doses. We set 5 ml/h basal infusion, 5 ml patient-controlled bolus and 20 min lock time. We prepared 2 mg remifentanil in 100 ml intravenous solution for Group 2. We set 20 mcg/h infusion, 0.05mcg/kg patient-controlled bolus and five min lock time. VAS, maternal-fetal heart rate, blood pressure, oxygen saturation, nausea-vomiting and sedation were recorded during labor. We recorded Apgar scores and maternal satisfaction at the end of labor.
RESULTS


The findings showed that both groups could provide adequate analgesia. However, VAS scores were higher in Group PCIVA. The mother satisfaction and newborn's Apgar scores were similar. In both groups, desaturation, which is requiring oxygen support, was not determined. The oxygen saturations were lower in Group 2. The side effects and patient satisfaction were similar in both groups.
CONCLUSION


Although PCIVA was found to be satisfactory concerning maternal satisfaction, VAS after 2nd hour were higher compared to PCEA. PCEA is the gold standard in labor analgesia. However, we believe that PCIVA is a good alternative to epidural analgesia in cases where epidural analgesia is contraindicated or where the patient does not want an epidural.",2020,The oxygen saturations were lower in Group 2.,"['37 pregnant women with a single fetus, who had labor analgesia']","['PCIVA', 'epidural patient-controlled analgesia and intravenous patient-controlled analgesia', 'remifentanil', 'PCEA', 'epidural analgesia (PCEA', 'remifentanil analgesia (PCIVA', 'Bupivacaine 1.25 mg/ml and fentanyl']","['VAS, maternal-fetal heart rate, blood pressure, oxygen saturation, nausea-vomiting and sedation', ""mother satisfaction and newborn's Apgar scores"", 'Apgar scores and maternal satisfaction', 'VAS scores', 'oxygen saturations', 'side effects and patient satisfaction']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0015965', 'cui_str': 'Fetus'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}]","[{'cui': 'C0078944', 'cui_str': 'Patient-Controlled Analgesia'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0002769', 'cui_str': 'Analgesia, Epidural'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C4517497', 'cui_str': '1.25 (qualifier value)'}, {'cui': 'C0439294', 'cui_str': 'mcg/mcL'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}]","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0018811', 'cui_str': 'Heart Rate, Fetal'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0003533', 'cui_str': 'Apgar Score'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}]",37.0,0.0285418,The oxygen saturations were lower in Group 2.,"[{'ForeName': 'Tayfun', 'Initials': 'T', 'LastName': 'Süğür', 'Affiliation': 'Health Sciences University, Antalya Training and Research Hospital, Anesthesiology and Reanimation Clinic, Antalya, Turkey.'}, {'ForeName': 'Esra', 'Initials': 'E', 'LastName': 'Kızılateş', 'Affiliation': 'VKV Medamerikan Medical Center, İstanbul, Turkey.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Kızılateş', 'Affiliation': 'Ministry of Health Sultanbeyli State Hospital, Istanbul, Turkey.'}, {'ForeName': 'Kerem', 'Initials': 'K', 'LastName': 'İnanoğlu', 'Affiliation': 'Health Sciences University, Antalya Training and Research Hospital, Anesthesiology and Reanimation Clinic, Antalya, Turkey.'}, {'ForeName': 'Bilge', 'Initials': 'B', 'LastName': 'Karslı', 'Affiliation': 'Department of Anesthesiology and Reanimation, Akdeniz University Faculty of Medicine, Antalya, Turkey.'}]",Agri : Agri (Algoloji) Dernegi'nin Yayin organidir = The journal of the Turkish Society of Algology,['10.14744/agri.2019.35403']
3600,32030695,[Effects of vibrating tourniquet application on the pain felt for blood drawing in pediatric patients].,"OBJECTIVES


In this study, it is planned to observe the effects of vibration tourniquet application on the pain felt in school-aged pediatric patients. This is a randomised study.
METHODS


The research population consisted of patients who were between ages 6 and 12 in the Pediatric Blood Drawing Unit at the Mersin University Research and Application Centers for diagnosis or treatment between dates of May 2017 and November 2017. The sample group consisted of 90 pediatric patients who were eligible for case taking criteria; 45 of them were control and other 45 of them were intervention group (vibrating tourniquet applied). All 90 patients agreed to participate in this study. The children information form was used to assess descriptive properties of children and Wong-Baker FACES- Pain Rating Scale was used for assessment of pain levels. In intervention group patients, blood was drawn with using vibrating tourniquet. Heart beat, respiration rate, blood pressure, fever and saturation level before and after blood drawn were measured for intervention and control group patients and they were asked to mark their level of pain on the Wong-Baker FACES Pain Rating Scale.
RESULTS


There was a statistically significant difference when vibrating-tourniquet-applied case and vibrating-tourniquet-not-applied control groups' mean pain points were compared (p<0.05).
CONCLUSION


In conclusion, the findings suggest that using vibrating tourniquet for drawing blood is effective in decreasing the pain level of children.",2020,"There was a statistically significant difference when vibrating-tourniquet-applied case and vibrating-tourniquet-not-applied control groups' mean pain points were compared (p<0.05).
","['pediatric patients', 'patients who were between ages 6 and 12 in the Pediatric Blood Drawing Unit at the Mersin University Research and Application Centers for diagnosis or treatment between dates of May 2017 and November 2017', 'school-aged pediatric patients', '90 pediatric patients who were eligible for case taking criteria; 45 of them were control and other 45 of them were intervention group (vibrating tourniquet applied']","['vibrating tourniquet application', 'vibration tourniquet application']","['level of pain on the Wong-Baker FACES Pain Rating Scale', 'pain level', 'descriptive properties of children and Wong-Baker FACES- Pain Rating Scale', 'Heart beat, respiration rate, blood pressure, fever and saturation level before and after blood drawn', 'mean pain points', 'pain felt']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0005768'}, {'cui': 'C0013113', 'cui_str': 'Drawing'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0035168'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0011008', 'cui_str': 'Dates'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0040519', 'cui_str': 'Tourniquets'}, {'cui': 'C1632850', 'cui_str': 'Apply'}]","[{'cui': 'C0204731', 'cui_str': 'Application of tourniquet (procedure)'}, {'cui': 'C0459800', 'cui_str': 'Vibration'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0238749', 'cui_str': 'Baker, general (occupation)'}, {'cui': 'C0015468', 'cui_str': 'Face Pain'}, {'cui': 'C0222045'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0871161', 'cui_str': 'Property (attribute)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C2256369', 'cui_str': 'Heart beating process'}, {'cui': 'C0231832', 'cui_str': 'Respiration Rate'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0190979', 'cui_str': 'Venesection'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}]",90.0,0.0231873,"There was a statistically significant difference when vibrating-tourniquet-applied case and vibrating-tourniquet-not-applied control groups' mean pain points were compared (p<0.05).
","[{'ForeName': 'Arzu', 'Initials': 'A', 'LastName': 'Özel', 'Affiliation': 'Department of Pediatrics, Mersin University Faculty of Nursing, Mersin, Turkey.'}, {'ForeName': 'Hacer', 'Initials': 'H', 'LastName': 'Çetin', 'Affiliation': 'Department of Pediatrics, Mersin University Faculty of Nursing, Mersin, Turkey.'}]",Agri : Agri (Algoloji) Dernegi'nin Yayin organidir = The journal of the Turkish Society of Algology,['10.14744/agri.2019.04900']
3601,30876827,"Unconjugated and secondary bile acid profiles in response to higher-fat, lower-carbohydrate diet and associated with related gut microbiota: A 6-month randomized controlled-feeding trial.","BACKGROUND & AIMS


Observational studies have shown that diets high in fat and low in dietary fiber, might have an unfavorable impact on bile acid (BA) profiles, which might further affect host cardiometabolic health. In the current study, we aimed to evaluate the effects of dietary fat content on BA profiles and associated gut microbiota, and their correlates with cardiometabolic risk factors.
METHODS


In a randomized controlled-feeding trial, healthy young adults were assigned to one of the three diets: a lower-fat diet (fat 20%, carbohydrate 66% and protein 14%), a moderate-fat diet (fat 30%, carbohydrate 56% and protein 14%) and a higher-fat diet (fat 40%, carbohydrate 46% and protein 14%) for 6 months. All the foods were provided during the entire intervention period. The BA profiles, associated gut microbiota and markers of cardiometabolic risk factors were determined before and after intervention.
RESULTS


The higher-fat diet resulted in an elevated concentration of total BAs (p < 0.001), and unconjugated BAs (p = 0.03) compared with lower-fat diet. Secondary BAs, such as deoxycholic acid (DCA), taurodeoxycholic acid (TDCA), 12ketolithocholic acid (12keto-LCA), 3β-DCA and taurolithocholic acid (TLCA) (p < 0.05 after FDR correction) were significantly increased in the higher-fat diet group after the 6-month intervention. Consistently, the abundances of gut bacteria (Bacteroides, Clostridium, Bifidobacterium and Lactobacillus) which affect bile salt hydrolase gene expression were significantly increased after higher-fat consumption. The change of DCA was positively associated with the relative abundance of Bacteroides (r = 0.31, p = 0.08 after FDR correction). In addition, the changes of fecal concentrations of DCA and 12keto-LCA were positively associated with serum total cholesterol (r > 0.3, p = 0.02 and p = 0.008 after FDR correction, respectively). In line with these findings, serum fibroblast growth factor 19 (FGF19) was marginally significantly elevated in the higher-fat group after intervention (p = 0.05).
CONCLUSIONS


The higher-fat diet resulted in an alteration of BAs, especially unconjugated BAs and secondary BAs, most likely through actions of gut microbiota. These alterations might confer potentially unfavorable impacts on colonic and host cardiometabolic health in healthy young adults. Clinical trial registry number: NCT02355795 listed on NIH website: ClinicalTrials.gov.",2020,"The higher-fat diet resulted in an elevated concentration of total BAs (p < 0.001), and unconjugated BAs (p = 0.03) compared with lower-fat diet.",['healthy young adults'],"['lower-fat diet (fat 20%, carbohydrate 66% and protein 14%), a moderate-fat diet (fat 30%, carbohydrate 56% and protein 14%) and a higher-fat diet']","['abundances of gut bacteria (Bacteroides, Clostridium, Bifidobacterium and Lactobacillus) which affect bile salt hydrolase gene expression', 'relative abundance of Bacteroides', 'serum fibroblast growth factor 19 (FGF19', 'Secondary BAs, such as deoxycholic acid (DCA), taurodeoxycholic acid (TDCA), 12ketolithocholic acid (12keto-LCA), 3β-DCA and taurolithocholic acid (TLCA', 'fecal concentrations of DCA and 12keto-LCA', 'BA profiles, associated gut microbiota and markers of cardiometabolic risk factors', 'serum total cholesterol', 'BA profiles and associated gut microbiota', 'elevated concentration of total BAs', 'unconjugated BAs']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0242970', 'cui_str': 'Fat-Restricted Diet'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0301585', 'cui_str': 'Fat diet (finding)'}, {'cui': 'C0521974', 'cui_str': 'Diet, High-Fat'}]","[{'cui': 'C1510439', 'cui_str': 'bacteria'}, {'cui': 'C0004661', 'cui_str': 'Bacteroides'}, {'cui': 'C0009054', 'cui_str': 'Clostridium'}, {'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}, {'cui': 'C0022938', 'cui_str': 'Lactobacillus'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0055580', 'cui_str': 'glycocholic acid hydrolase'}, {'cui': 'C0017262', 'cui_str': 'Gene Expression'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0016026', 'cui_str': 'DNA Synthesis Factor'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0011479', 'cui_str': 'Deoxycholic Acid'}, {'cui': 'C0039360', 'cui_str': 'Deoxycholyltaurine'}, {'cui': 'C0001128', 'cui_str': 'Acids'}, {'cui': 'C0600203', 'cui_str': 'DCA'}, {'cui': 'C0039362', 'cui_str': 'Lithocholyltaurine'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C4018878', 'cui_str': 'Gastrointestinal Microbial Community'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}]",,0.0218642,"The higher-fat diet resulted in an elevated concentration of total BAs (p < 0.001), and unconjugated BAs (p = 0.03) compared with lower-fat diet.","[{'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Wan', 'Affiliation': 'Department of Food Science and Nutrition, Zhejiang University, Hangzhou, 310058, China.'}, {'ForeName': 'Jihong', 'Initials': 'J', 'LastName': 'Yuan', 'Affiliation': ""No. 1 Department of Nutrition, Chinese People's Liberation Army General Hospital, Beijing, China.""}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ""No. 1 Department of Nutrition, Chinese People's Liberation Army General Hospital, Beijing, China.""}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Food Science and Nutrition, Zhejiang University, Hangzhou, 310058, China.'}, {'ForeName': 'Jingjing', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Gastroenterology, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, 310058, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Tang', 'Affiliation': 'Department of Food Science and Nutrition, Zhejiang University, Hangzhou, 310058, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Ni', 'Affiliation': ""The Children's Hospital, School of Medicine, Zhejiang University, Hangzhou 310024, China.""}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Huang', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Peking University Health Science Center, Beijing, 100191, China.'}, {'ForeName': 'Fenglei', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': 'Department of Food Science and Nutrition, Zhejiang University, Hangzhou, 310058, China; Department of Nutrition, Harvard T. H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Zhao', 'Affiliation': 'Institute of Nutrition and Health, Qingdao University, Qingdao, 266071, China. Electronic address: fengzhao21c@126.com.'}, {'ForeName': 'Duo', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': 'Department of Food Science and Nutrition, Zhejiang University, Hangzhou, 310058, China; Institute of Nutrition and Health, Qingdao University, Qingdao, 266071, China. Electronic address: duoli@qdu.edu.cn.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2019.02.037']
3602,31813388,"Increased consumption of calcium from fat-free milk, energy-restricted diet and educational activities improves metabolic control in overweight type 2 diabetic patients.","We assessed the effects of increased Ca consumption from fat-free milk in an energy-restricted diet and educational activities in the metabolic control of overweight type 2 diabetes mellitus (T2DM) patients. Fourteen subjects with T2DM (BMI 29·4 (sd 4·5) kg/m2, low habitual Ca consumption (<600 mg/d)) were included in this randomised, crossover clinical trial. Subjects were randomly allocated to one of the two interventions: drink containing 700 mg of Ca (DAIR) or drink containing 0 mg of Ca (CONT) for ninety consecutive days each. Energy-restricted diets (-500 kcal/d; -2092 kJ/d), containing 800 mg of Ca from dietary sources/d, were prescribed for both groups. Questionnaires were applied at baseline and at the end of the study to assess the subjects' knowledge on the disease and on self-care, biochemical variables and physical activity. Blood pressure, food intake, body composition and anthropometry were assessed at baseline, days 45 and 90. There was a higher reduction of body fat %, waist circumference, hip circumference, neck circumference, waist:hip ratio, sagittal abdominal diameter, diastolic/systolic blood pressure and an increase in fat-free mass % in DAIR than in CONT. Uric acid, fasting glucose, Hb1Ac, parathyroid hormone and alanine aminotransferase concentrations reduced and vitamin D concentration increased after 90 d in DAIR compared with CONT. The consumption of energy-restricted diet containing 1200 mg Ca/d seems to favour metabolic control in subjects with T2DM. The educational activities increased the knowledge on the disease care.",2020,"There was a higher reduction of body fat %, waist circumference, hip circumference, neck circumference, waist:hip ratio, sagittal abdominal diameter, diastolic/systolic blood pressure and an increase in fat-free mass % in DAIR than in CONT.","['overweight type 2 diabetic patients', 'subjects with T2DM', 'Fourteen subjects with T2DM', 'overweight type 2 diabetes mellitus (T2DM) patients']","['drink containing 700 mg of Ca (DAIR) or drink containing 0 mg of Ca (CONT', 'increased Ca consumption from fat-free milk in an energy-restricted diet and educational activities']","['Uric acid, fasting glucose, Hb1Ac, parathyroid hormone and alanine aminotransferase concentrations reduced and vitamin D concentration', 'body fat %, waist circumference, hip circumference, neck circumference, waist:hip ratio, sagittal abdominal diameter, diastolic/systolic blood pressure', 'Blood pressure, food intake, body composition and anthropometry']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}]","[{'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C4517862', 'cui_str': '700 (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0443288', 'cui_str': 'Restricted (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0013652', 'cui_str': 'Educational Activities'}]","[{'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0030520', 'cui_str': 'Parathyroid Hormone'}, {'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0562350', 'cui_str': 'Hip circumference (observable entity)'}, {'cui': 'C1630403', 'cui_str': 'Neck circumference'}, {'cui': 'C0230097', 'cui_str': 'Waist (surface region)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C2828149', 'cui_str': 'Supine Abdominal Height'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}]",14.0,0.0171495,"There was a higher reduction of body fat %, waist circumference, hip circumference, neck circumference, waist:hip ratio, sagittal abdominal diameter, diastolic/systolic blood pressure and an increase in fat-free mass % in DAIR than in CONT.","[{'ForeName': 'Jorge de Assis', 'Initials': 'JA', 'LastName': 'Costa', 'Affiliation': 'Instituto Federal do Sudeste de Minas Gerais (UEMG) - Campus Barbacena, Barbacena, Minas GeraisCEP 36205-018, Brazil.'}, {'ForeName': 'Júnia Maria Geraldo', 'Initials': 'JMG', 'LastName': 'Gomes', 'Affiliation': 'Instituto Federal do Sudeste de Minas Gerais (UEMG) - Campus Barbacena, Barbacena, Minas GeraisCEP 36205-018, Brazil.'}, {'ForeName': 'Priscila Vaz de Melo', 'Initials': 'PVM', 'LastName': 'Ribeiro', 'Affiliation': 'Departamento de Nutrição e Saúde, Universidade Federal de Viçosa, Viçosa, Minas GeraisCEP 36570-000, Brazil.'}, {'ForeName': 'Rita de Cássia Gonçalves', 'Initials': 'RCG', 'LastName': 'Alfenas', 'Affiliation': 'Departamento de Nutrição e Saúde, Universidade Federal de Viçosa, Viçosa, Minas GeraisCEP 36570-000, Brazil.'}]",The British journal of nutrition,['10.1017/S0007114519003192']
3603,32016118,Combination of Intravitreal Bevacizumab and Topical Dorzolamide versus Intravitreal Bevacizumab Alone for Diabetic Macular Edema: A Randomized Contralateral Clinical Trial.,"Purpose


To evaluate the efficacy of three intravitreal bevacizumab (IVB) injections versus the same combined with 2% of topical dorzolamide in the treatment of diabetic macular edema (DME).
Methods


In this randomized double-masked clinical trial, 32 eyes of 16 treatment-naive patients with bilateral DME were enrolled. The eyes were randomly assigned to receive three monthly injections of IVB (1.25 mg) plus topical dorzolamide 2% twice daily or IVB (1.25 mg) plus topical artificial tear twice daily. Best-corrected visual acuity (BCVA) was the primary outcome of the study followed by the central macular thickness (CMT) and central macular volume (CMV) as the secondary outcomes.
Results


Mean BCVA changes were insignificant in both groups. It changed from 0.21 ± 0.08 logMAR at baseline to 0.23 ± 0.09 ( P =0.24) in the combination group and from 0.18 ± 0.09 logMAR to 0.21 ± 0.09 ( P =0.11) in the IVB alone group, at 3 months, respectively. Changes in mean CMT and CMV were significant in both groups. However, the difference between the groups was not significant at all the visits. In the study, no major ocular complication or systemic side effects were noted regarding IVB or topical dorzolamide.
Conclusion


This randomized contralateral clinical trial demonstrated that adjuvant topical dorzolamide with IVB injection had no additional effects on IVB in the treatment of DME over a three-month course. This trial is registered with the Iranian Registry of Clinical Trials under the registration code IRCT20131229015975N5.",2020,This randomized contralateral clinical trial demonstrated that adjuvant topical dorzolamide with IVB injection had no additional effects on IVB in the treatment of DME over a three-month course.,"['32 eyes of 16 treatment-naive patients with bilateral DME were enrolled', 'diabetic macular edema (DME', 'Diabetic Macular Edema']","['Intravitreal Bevacizumab and Topical Dorzolamide', 'topical dorzolamide', 'Intravitreal Bevacizumab Alone', 'adjuvant topical dorzolamide with IVB injection', 'IVB (1.25\u2009mg) plus topical dorzolamide 2% twice daily or IVB (1.25\u2009mg) plus topical artificial tear twice daily', 'intravitreal bevacizumab (IVB) injections']","['Best-corrected visual acuity (BCVA', 'mean CMT and CMV', 'central macular thickness (CMT) and central macular volume (CMV', 'Mean BCVA changes']","[{'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0641456', 'cui_str': 'DMES'}, {'cui': 'C0730285', 'cui_str': 'Diabetic macular edema'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0165590', 'cui_str': 'dorzolamide'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C4517497', 'cui_str': '1.25 (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C2608262', 'cui_str': 'Lubricating Eye Drops'}, {'cui': 'C4033858', 'cui_str': 'bevacizumab Injection [Avastin]'}]","[{'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",32.0,0.188942,This randomized contralateral clinical trial demonstrated that adjuvant topical dorzolamide with IVB injection had no additional effects on IVB in the treatment of DME over a three-month course.,"[{'ForeName': 'Farhad', 'Initials': 'F', 'LastName': 'Fazel', 'Affiliation': 'Isfahan Eye Research Center, Department of Ophthalmology, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Nikpour', 'Affiliation': 'Isfahan Eye Research Center, Department of Ophthalmology, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Pourazizi', 'Affiliation': 'Isfahan Eye Research Center, Department of Ophthalmology, Isfahan University of Medical Sciences, Isfahan, Iran.'}]",BioMed research international,['10.1155/2020/6794391']
3604,32020044,Lenalidomide added to standard intensive treatment for older patients with AML and high-risk MDS.,"More effective treatment modalities are urgently needed in patients with acute myeloid leukemia (AML) of older age. We hypothesized that adding lenalidomide to intensive standard chemotherapy might improve their outcome. After establishing a safe lenalidomide, dose elderly patients with AML were randomly assigned in this randomized Phase 2 study (n = 222) to receive standard chemotherapy (""3 + 7"") with or without lenalidomide at a dose of 20 mg/day 1-21. In the second cycle, patients received cytarabine 1000 mg/m 2  twice daily on days 1-6 with or without lenalidomide (20 mg/day 1-21). The CR/CRi rates in the two arms were not different (69 vs. 66%). Event-free survival (EFS) at 36 months was 19% for the standard arm versus 21% for the lenalidomide arm and overall survival (OS) 35% vs. 30%, respectively. The frequencies and grade of adverse events were not significantly different between the treatment arms. Cardiovascular toxicities were rare and equally distributed between the arms. The results of the present study show that the addition of lenalidomide to standard remission induction chemotherapy does not improve the therapeutic outcome of older AML patients. This trial is registered as number NTR2294 in The NederlandsTrial Register (www.trialregister.nl).",2020,The frequencies and grade of adverse events were not significantly different between the treatment arms.,"['older AML patients', 'patients with acute myeloid leukemia (AML) of older age', 'elderly patients with AML', 'older patients with AML and high-risk MDS']","['Lenalidomide', 'cytarabine 1000\u2009mg/m 2  twice daily on days 1-6 with or without lenalidomide', 'standard chemotherapy (""3\u2009+\u20097"") with or without lenalidomide']","['frequencies and grade of adverse events', 'Event-free survival (EFS', 'CR/CRi rates', 'Cardiovascular toxicities', 'overall survival']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C1999167', 'cui_str': 'Old-age (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0265219', 'cui_str': 'Lissencephaly Syndrome, Miller-Dieker'}]","[{'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C3179739', 'cui_str': '(LaCit2)3+'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.103256,The frequencies and grade of adverse events were not significantly different between the treatment arms.,"[{'ForeName': 'G J', 'Initials': 'GJ', 'LastName': 'Ossenkoppele', 'Affiliation': 'Amsterdam University Medical Cente, location VUMC, Amsterdam, Netherlands. g.ossenkoppele@amsterdamumc.nl.'}, {'ForeName': 'D A', 'Initials': 'DA', 'LastName': 'Breems', 'Affiliation': 'Netwerk Antwerpen, Antwerp, Belgium.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Stuessi', 'Affiliation': 'Bellinzona-IOSI, Bellinzona, Switzerland.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'van Norden', 'Affiliation': 'HOVON Data Center, Erasmus MC- Department of Hematology, Rotterdam, The Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bargetzi', 'Affiliation': 'Aarau- Kantonsspital, Aarau, Switzerland.'}, {'ForeName': 'B J', 'Initials': 'BJ', 'LastName': 'Biemond', 'Affiliation': 'Amsterdam University Medical Center, location AMC, Amsterdam, Netherlands.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'A von dem Borne', 'Affiliation': 'Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Chalandon', 'Affiliation': 'University Hospital and University of Geneva, Genève, Switzerland.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Cloos', 'Affiliation': 'Amsterdam University Medical Cente, location VUMC, Amsterdam, Netherlands.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Deeren', 'Affiliation': 'Roeselare-AZ Delta, Roeselare, Belgium.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Fehr', 'Affiliation': 'St Gallen-Kantonnsspital, St. Gallen, Switzerland.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Gjertsen', 'Affiliation': 'Haukeland University Hospital, Bergen (N), Norway.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Graux', 'Affiliation': 'Yvoir-MontGodinne, Yvoir, Belgium.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Huls', 'Affiliation': 'University Medical Center, Groningen, Netherlands.'}, {'ForeName': 'J J J W', 'Initials': 'JJJW', 'LastName': 'Janssen', 'Affiliation': 'Amsterdam University Medical Cente, location VUMC, Amsterdam, Netherlands.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Jaspers', 'Affiliation': 'Hôpital Citadelle, Liège (B), Belgium.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Jongen-Lavrencic', 'Affiliation': 'Erasmus University Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'de Jongh', 'Affiliation': 'Dordrecht ASZ, Dordrecht, Netherlands.'}, {'ForeName': 'S K', 'Initials': 'SK', 'LastName': 'Klein', 'Affiliation': 'Meander Medical Center, Amersfoort, Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'van der Klift', 'Affiliation': 'Amphia-Breda, Breda, Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'van Marwijk Kooy', 'Affiliation': 'Isala Hospital, Zwolle, Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Maertens', 'Affiliation': 'Hospital Gasthuisberg, Leuven (B), Belgium.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Michaux', 'Affiliation': 'Center for Human Genetics, KU Leuven and University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'M W M', 'Initials': 'MWM', 'LastName': 'van der Poel', 'Affiliation': 'Maastricht University Medical Center, Maastricht, Netherlands.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'van Rhenen', 'Affiliation': 'UMC Utrecht, Utrecht, Netherlands.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Tick', 'Affiliation': 'MaximaMC Eindhoven, Eindhoven, Netherlands.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Valk', 'Affiliation': 'Hôpital Citadelle, Liège (B), Belgium.'}, {'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'Vekemans', 'Affiliation': 'Hôpital St Luc, Bruxelles, Belgium.'}, {'ForeName': 'W J F M', 'Initials': 'WJFM', 'LastName': 'van der Velden', 'Affiliation': 'Radboudumc Nijmegen, Nijmegen, Netherlands.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'de Weerdt', 'Affiliation': 'St Antonius Hospital, Nieuwegein, Netherlands.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Pabst', 'Affiliation': 'Department of Oncology, University Hospital, Inselspital and University of Bern, Bern, Switzerland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Manz', 'Affiliation': 'University Hospital, Zurich, Switzerland.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Löwenberg', 'Affiliation': 'Hôpital Citadelle, Liège (B), Belgium.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Leukemia,['10.1038/s41375-020-0725-0']
3605,30852029,"Prediabetes diagnosis criteria, type 2 diabetes risk and dietary modulation: The CORDIOPREV study.","AIM


Our objective was to investigate the role of two healthy diets in modulating the risk of type 2 diabetes (T2DM) development associated with each prediabetes diagnosis criteria in coronary heart disease patients. Additionally, we explored the pathophysiological characteristics and the risk of developing T2DM in patients with different prediabetes criteria.
METHODS


We included 462 patients from the CORDIOPREV study without T2DM at baseline: 213 had prediabetes defined by impaired fasting glucose (IFG) and/or impaired glucose tolerance (IGT) (PreDM-IFG/IGT); 180 had prediabetes by isolated hemoglobin glycated plasma levels (PreDM-isolated-HbA1c), and 69 were not prediabetics (non-PreDM), according to the American Diabetes Association criteria. Patients were randomized to consume either a Mediterranean or a low-fat diet. We performed a COX proportional hazards regression analysis to determine the T2DM risk according to diet and the prediabetes criteria after a median follow-up of 60 months.
RESULTS


We found higher T2DM risk (HR: 2.98; 95% CI 1.27-6.98) in PreDM-IFG/IGT than in PreDM-isolated-HbA1c (HR: 2.31; 95% CI 0.97-5.49) compared with non-PreDM. Long-term consumption of a low-fat diet was associated with a lower risk of T2DM when compared to the Mediterranean diet in the PreDM-IFG/IGT group (HR: 3.20; 95% CI 0.75-13.69 versus HR: 4.70; 95% CI 1.12-19.67, respectively). Moreover, we found the highest risk of T2DM development associated with patients who had both IFG and IGT (HR: 2.15; 95% CI 1.11-4.16). Patients who had both IFG and IGT and consumed a low-fat diet had a lower T2DM risk than those who consumed a Mediterranean diet (HR: 1.53; 95% CI 0.53-4.39 versus HR: 3.33; 95% CI 1.34-8.30, respectively).
CONCLUSION


Our results suggest that the type of diet consumed may modulate the risk of T2DM development according to the prediabetes diagnosis criteria. Specifically, our study showed that the consumption of a low-fat diet was more beneficial than a Mediterranean diet in patients with IFG and IGT.
CLINICAL TRIAL REGISTRATION NUMBER


ClinicalTrials.govNCT00924937.",2020,"Long-term consumption of a low-fat diet was associated with a lower risk of T2DM when compared to the Mediterranean diet in the PreDM-IFG/IGT group (HR: 3.20; 95% CI 0.75-13.69 versus HR: 4.70; 95% CI 1.12-19.67, respectively).","['coronary heart disease patients', '462 patients from the CORDIOPREV study without T2DM at baseline', '180 had prediabetes by isolated hemoglobin glycated plasma levels (PreDM-isolated-HbA1c), and 69 were not prediabetics (non-PreDM), according to the American Diabetes Association criteria', 'patients with different prediabetes criteria', 'Prediabetes diagnosis criteria, type 2 diabetes risk and dietary modulation']","['Mediterranean or a low-fat diet', 'healthy diets', 'PreDM-IFG/IGT']","['lower risk of T2DM', 'impaired fasting glucose (IFG) and/or impaired glucose tolerance (IGT', 'risk of T2DM development', 'T2DM risk', 'highest risk of T2DM development']","[{'cui': 'C0010068', 'cui_str': 'Coronary Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0362046', 'cui_str': 'Prediabetes'}, {'cui': 'C0205409', 'cui_str': 'Isolated (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C3666909', 'cui_str': 'Glycate'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]","[{'cui': 'C0242970', 'cui_str': 'Fat-Restricted Diet'}, {'cui': 'C0452415', 'cui_str': 'Healthy Diet'}]","[{'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0221099', 'cui_str': 'Impaired (qualifier value)'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}]",462.0,0.048523,"Long-term consumption of a low-fat diet was associated with a lower risk of T2DM when compared to the Mediterranean diet in the PreDM-IFG/IGT group (HR: 3.20; 95% CI 0.75-13.69 versus HR: 4.70; 95% CI 1.12-19.67, respectively).","[{'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Roncero-Ramos', 'Affiliation': 'Lipids and Atherosclerosis Unit, Department of Internal Medicine, Maimonides Biomedical Research Institute of Cordoba (IMIBIC), Reina Sofia University Hospital, University of Cordoba, Spain; CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III, Cordoba, Spain.'}, {'ForeName': 'Juan F', 'Initials': 'JF', 'LastName': 'Alcala-Diaz', 'Affiliation': 'Lipids and Atherosclerosis Unit, Department of Internal Medicine, Maimonides Biomedical Research Institute of Cordoba (IMIBIC), Reina Sofia University Hospital, University of Cordoba, Spain; CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III, Cordoba, Spain.'}, {'ForeName': 'Oriol A', 'Initials': 'OA', 'LastName': 'Rangel-Zuñiga', 'Affiliation': 'Lipids and Atherosclerosis Unit, Department of Internal Medicine, Maimonides Biomedical Research Institute of Cordoba (IMIBIC), Reina Sofia University Hospital, University of Cordoba, Spain; CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III, Cordoba, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Gomez-Delgado', 'Affiliation': 'Lipids and Atherosclerosis Unit, Department of Internal Medicine, Maimonides Biomedical Research Institute of Cordoba (IMIBIC), Reina Sofia University Hospital, University of Cordoba, Spain; CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III, Cordoba, Spain.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Jimenez-Lucena', 'Affiliation': 'Lipids and Atherosclerosis Unit, Department of Internal Medicine, Maimonides Biomedical Research Institute of Cordoba (IMIBIC), Reina Sofia University Hospital, University of Cordoba, Spain; CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III, Cordoba, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'García-Rios', 'Affiliation': 'Lipids and Atherosclerosis Unit, Department of Internal Medicine, Maimonides Biomedical Research Institute of Cordoba (IMIBIC), Reina Sofia University Hospital, University of Cordoba, Spain; CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III, Cordoba, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Vals-Delgado', 'Affiliation': 'Lipids and Atherosclerosis Unit, Department of Internal Medicine, Maimonides Biomedical Research Institute of Cordoba (IMIBIC), Reina Sofia University Hospital, University of Cordoba, Spain; CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III, Cordoba, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Romero-Baldonado', 'Affiliation': 'Biochemical Laboratory, Reina Sofia University Hospital, Córdoba, Spain.'}, {'ForeName': 'Raul M', 'Initials': 'RM', 'LastName': 'Luque', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III, Cordoba, Spain; Department of Cell Biology, Physiology, and Immunology, University of Córdoba, Reina Sofía University Hospital, Maimonides Biomedical Research Institute of Córdoba (IMIBIC), Córdoba, Spain.'}, {'ForeName': 'Jose M', 'Initials': 'JM', 'LastName': 'Ordovas', 'Affiliation': 'Nutrition and Genomics Laboratory, J.M.-US Department of Agriculture Human Nutrition Research Center on Aging at Tufts University, Boston, Massachusetts, Spain; IMDEA Alimentacion, Madrid, Spain; CNIC, Madrid, Spain.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Perez-Martinez', 'Affiliation': 'Lipids and Atherosclerosis Unit, Department of Internal Medicine, Maimonides Biomedical Research Institute of Cordoba (IMIBIC), Reina Sofia University Hospital, University of Cordoba, Spain; CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III, Cordoba, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Camargo', 'Affiliation': 'Lipids and Atherosclerosis Unit, Department of Internal Medicine, Maimonides Biomedical Research Institute of Cordoba (IMIBIC), Reina Sofia University Hospital, University of Cordoba, Spain; CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III, Cordoba, Spain.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Lopez-Miranda', 'Affiliation': 'Lipids and Atherosclerosis Unit, Department of Internal Medicine, Maimonides Biomedical Research Institute of Cordoba (IMIBIC), Reina Sofia University Hospital, University of Cordoba, Spain; CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III, Cordoba, Spain. Electronic address: jlopezmir@uco.es.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2019.02.027']
3606,32024950,"Daratumumab monotherapy for patients with intermediate-risk or high-risk smoldering multiple myeloma: a randomized, open-label, multicenter, phase 2 study (CENTAURUS).","Current guidelines for smoldering multiple myeloma (SMM) recommend active monitoring until the onset of multiple myeloma (MM) before initiating treatment or enrollment in a clinical trial. Earlier intervention may delay progression to MM. In CENTAURUS, 123 patients with intermediate-risk or high-risk SMM were randomly assigned to daratumumab 16 mg/kg intravenously on extended intense (intense), extended intermediate (intermediate), or short dosing schedules. At the prespecified primary analysis (15.8-month median follow-up), the complete response (CR) rates (co-primary endpoint) were 2.4%, 4.9%, and 0% for intense, intermediate, and short dosing, respectively; the co-primary endpoint of CR rate >15% was not met. Progressive disease (PD)/death rates (number of patients who progressed or died divided by total duration of progression-free survival [PFS] in patient-years; co-primary endpoint) for intense, intermediate, and short dosing were 0.055 (80% confidence interval [CI], 0.014-0.096), 0.102 (80% CI, 0.044-0.160), and 0.206 (80% CI, 0.118-0.295), respectively, translating to a median PFS ≥24 months in all arms (P < 0.0001, <0.0001, and =0.0213, respectively). With longer follow-up (median follow-up, 25.9 months), CR rates were 4.9%, 9.8%, and 0% for intense, intermediate, and short dosing, respectively. PD/death rates for intense, intermediate, and short dosing were 0.059 (80% CI, 0.025-0.092), 0.107 (80% CI, 0.058-0.155), and 0.150 (80% CI, 0.089-0.211), respectively, again translating to a median PFS ≥ 24 months in all arms (P < 0.0001 for all arms). Twenty-four-month PFS rates were 89.9% (90% CI, 78.5-95.4%), 82.0% (90% CI, 69.0-89.9%), and 75.3% (90% CI, 61.1-85.0%) for intense, intermediate, and short dosing, respectively. Pharmacokinetic analyses indicated that intense dosing maintained target-saturating trough concentrations in most patients throughout weekly, every-2-week, and every-4-week dosing periods. No new safety signals were observed. These data provide the basis for an ongoing phase 3 study of daratumumab in SMM.",2020,"PD/death rates for intense, intermediate, and short dosing were 0.059 (80% CI, 0.025-0.092), 0.107 (80% CI, 0.058-0.155), and 0.150 (80% CI, 0.089-0.211), respectively, again translating to a median PFS ≥ 24 months in all arms (P < 0.0001 for all arms).","['patients with intermediate-risk or high-risk smoldering multiple myeloma', '123 patients with intermediate-risk or high-risk SMM']","['Daratumumab monotherapy', 'daratumumab 16\u2009mg/kg intravenously on extended intense (intense), extended intermediate (intermediate']","['Progressive disease (PD)/death rates', 'CR rates', 'CR rate', 'PD/death rates', 'PFS rates', 'complete response (CR) rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C1531608', 'cui_str': 'Asymptomatic Multiple Myeloma'}]","[{'cui': 'C2346801', 'cui_str': 'daratumumab'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0231449', 'cui_str': 'Extended (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}]","[{'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]",123.0,0.0578349,"PD/death rates for intense, intermediate, and short dosing were 0.059 (80% CI, 0.025-0.092), 0.107 (80% CI, 0.058-0.155), and 0.150 (80% CI, 0.089-0.211), respectively, again translating to a median PFS ≥ 24 months in all arms (P < 0.0001 for all arms).","[{'ForeName': 'C Ola', 'Initials': 'CO', 'LastName': 'Landgren', 'Affiliation': 'Department of Medicine, Myeloma Service, Memorial Sloan Kettering Cancer Center, New York, NY, USA. landgrec@mskcc.org.'}, {'ForeName': 'Ajai', 'Initials': 'A', 'LastName': 'Chari', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Yael C', 'Initials': 'YC', 'LastName': 'Cohen', 'Affiliation': 'Department of Hematology, Tel-Aviv Sourasky (Ichilov) Medical Center, and Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Spencer', 'Affiliation': 'Malignant Haematology and Stem Cell Transplantation Service, Alfred Health-Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Voorhees', 'Affiliation': 'Levine Cancer Institute/Atrium Health, Charlotte, NC, USA.'}, {'ForeName': 'Jane A', 'Initials': 'JA', 'LastName': 'Estell', 'Affiliation': 'Haematology Department, Concord Cancer Centre, Concord Hospital, University of Sydney, Concord, NSW, Australia.'}, {'ForeName': 'Irwindeep', 'Initials': 'I', 'LastName': 'Sandhu', 'Affiliation': 'Department of Medicine, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Matthew W', 'Initials': 'MW', 'LastName': 'Jenner', 'Affiliation': 'Southampton General Hospital, Southampton, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Williams', 'Affiliation': 'Department of Clinical Haematology, Nottingham University Hospitals, Nottinghamshire, UK.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Cavo', 'Affiliation': 'Department of Experimental, Diagnostic and Specialty Medicine, ""Seràgnoli"" Institute of Hematology, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Niels W C J', 'Initials': 'NWCJ', 'LastName': 'van de Donk', 'Affiliation': 'Department of Hematology, VU University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Meral', 'Initials': 'M', 'LastName': 'Beksac', 'Affiliation': 'Department of Hematology, Ankara University, Ankara, Turkey.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Moreau', 'Affiliation': 'University Hospital Hôtel-Dieu, Nantes, France.'}, {'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Goldschmidt', 'Affiliation': 'University Hospital Heidelberg and National Center of Tumor Diseases (NCT), Heidelberg, Germany.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Kuppens', 'Affiliation': 'Janssen Research & Development, Beerse, Belgium.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Bandekar', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Pamela L', 'Initials': 'PL', 'LastName': 'Clemens', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Neff', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Heuck', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Qi', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Craig C', 'Initials': 'CC', 'LastName': 'Hofmeister', 'Affiliation': 'Department of Hematology & Oncology, Winship Cancer Institute of Emory University, Atlanta, GA, USA. Craig.Hofmeister@emory.edu.'}]",Leukemia,['10.1038/s41375-020-0718-z']
3607,32022581,Electroacupuncture versus manual acupuncture for knee osteoarthritis: a randomized controlled pilot trial.,"OBJECTIVE


We aimed to explore the feasibility of evaluating the comparative effectiveness and safety of electroacupuncture (EA) relative to manual acupuncture (MA) for the treatment of knee osteoarthritis (KOA).
METHODS


A multicenter randomized controlled clinical trial was conducted in Beijing from September 2017 to January 2018. A total of 60 participants with KOA were randomly allocated to either EA ( n  = 30) or MA ( n  = 30) groups. Participants in the EA group were treated with EA at six to seven local traditional acupuncture points or  ah shi  points, and two to three distal points. Participants in the MA group had the same schedule as the EA group except that the electrical apparatus featured a working power indicator without actual current output, constituting a sham EA procedure, in order to blind participants. Both groups received 24 sessions over 8 weeks. The primary outcome was response rate, defined as a change of ⩾50% from baseline in the total scores of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) after 8 weeks. Secondary outcomes included pain, stiffness, function, quality of life, and acupuncture-related adverse events (AEs) at 4 and 8 weeks.
RESULTS


Of 60 participants randomized, 53 (88%) completed the study. Response rates were 43% for the EA group and 30% for the MA group by the intention-to-treat analysis. Although significant differences were observed in WOMAC pain, stiffness, and function scores within both groups, between-group differences at 8 weeks did not reach statistical significance (odds ratio = 1.75 (95% confidence interval = 0.593-5.162)). Rates of AEs were low and similarly distributed between groups.
CONCLUSION


Both EA and MA interventions in KOA were feasible and appeared safe. Whether or not EA may have a stronger impact on pain and function requires further evaluation through larger, adequately powered, randomized controlled trials.
TRIAL REGISTRATION NUMBER


NCT03274713.",2020,Response rates were 43% for the EA group and 30% for the MA group by the intention-to-treat analysis.,"['knee osteoarthritis (KOA', '60 participants with KOA', '60 participants randomized, 53 (88%) completed the study', 'Beijing from September 2017 to January 2018', 'knee osteoarthritis']","['EA', 'EA at six to seven local traditional acupuncture points or  ah shi  points', 'manual acupuncture', 'electroacupuncture (EA) relative to manual acupuncture (MA', 'Electroacupuncture', 'MA']","['pain, stiffness, function, quality of life, and acupuncture-related adverse events (AEs', 'Response rates', 'Rates of AEs', 'WOMAC pain, stiffness, and function scores', 'response rate, defined as a change of ⩾50% from baseline in the total scores of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4042832', 'cui_str': 'Peking'}]","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0001302', 'cui_str': 'Acupoints'}, {'cui': 'C0450897', 'cui_str': 'Ah Shi (body structure)'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0427008', 'cui_str': 'Stiffness (finding)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0034380'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C3472647', 'cui_str': 'WOMAC index'}]",60.0,0.263221,Response rates were 43% for the EA group and 30% for the MA group by the intention-to-treat analysis.,"[{'ForeName': 'Tian-Qi', 'Initials': 'TQ', 'LastName': 'Wang', 'Affiliation': 'Acupuncture Research Center, School of Acupuncture, Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Yong-Ting', 'Initials': 'YT', 'LastName': 'Li', 'Affiliation': 'Acupuncture Research Center, School of Acupuncture, Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Li-Qiong', 'Initials': 'LQ', 'LastName': 'Wang', 'Affiliation': 'Acupuncture Research Center, School of Acupuncture, Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Guang-Xia', 'Initials': 'GX', 'LastName': 'Shi', 'Affiliation': 'Acupuncture Research Center, School of Acupuncture, Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Jian-Feng', 'Initials': 'JF', 'LastName': 'Tu', 'Affiliation': 'Department of Acupuncture and Moxibustion, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing, China.'}, {'ForeName': 'Jing-Wen', 'Initials': 'JW', 'LastName': 'Yang', 'Affiliation': 'Acupuncture Research Center, School of Acupuncture, Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Ya-Quan', 'Initials': 'YQ', 'LastName': 'Hou', 'Affiliation': 'Acupuncture Research Center, School of Acupuncture, Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Lu-Lu', 'Initials': 'LL', 'LastName': 'Lin', 'Affiliation': 'Acupuncture Research Center, School of Acupuncture, Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Sun', 'Affiliation': 'Acupuncture and Tuina School, Chengdu University of Traditional Chinese Medicine, Chengdu, China.'}, {'ForeName': 'Jing-Jie', 'Initials': 'JJ', 'LastName': 'Zhao', 'Affiliation': 'Department of Acupuncture and Moxibustion, Beijing Friendship Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Hai-Kun', 'Initials': 'HK', 'LastName': 'Hou', 'Affiliation': 'Department of Acupuncture and Moxibustion, Beijing Jishuitan Hospital, The Fourth Medical College of Peking University, Beijing, China.'}, {'ForeName': 'Cun-Zhi', 'Initials': 'CZ', 'LastName': 'Liu', 'Affiliation': 'Acupuncture Research Center, School of Acupuncture, Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China.'}]",Acupuncture in medicine : journal of the British Medical Acupuncture Society,['10.1177/0964528419900781']
3608,32023537,Exploration of Habitual Walking Behavior and Home-Based Muscle Power Training in Individuals With Total Knee Arthroplasty.,"BACKGROUND


The purpose of this study was to investigate the effects of a home-based muscle power training program on muscle strength and power, functional performance, and physical activity behavior in individuals at least 6 months posttotal knee arthroplasty.
METHODS


Twelve men and women, mean age 63.9 (6.8) and 6 months to 2 years posttotal knee arthroplasty unilateral or bilateral), completed this study. Participants were randomly assigned to the home-based power training intervention or step-monitoring comparison group. Quadriceps muscle strength and power, 6-minute walk test, functional leg power, and habitual walking behavior (average daily steps, minutes per week of moderate to vigorous physical activity) were assessed before and after intervention and then compared between and within groups.
RESULTS


The authors found no significant differences between the groups on amount of change in any of the outcomes, but mixed results on differences within each of the groups on the outcome measures.
CONCLUSION


There were no differences between the groups for amount of change on the outcome measures the authors selected. Although within group differences varied slightly for each group, it was not enough to justify the more expensive home-based power training over the simpler step-monitoring intervention.",2020,There were no differences between the groups for amount of change on the outcome measures the authors selected.,"['Twelve men and women, mean age 63.9 (6.8) and 6 months to 2 years posttotal knee arthroplasty unilateral or bilateral', 'Individuals With Total Knee Arthroplasty', 'individuals at least 6 months posttotal knee arthroplasty']","['Habitual Walking Behavior and Home-Based Muscle Power Training', 'home-based muscle power training program', 'home-based power training intervention or step-monitoring comparison group']","['Quadriceps muscle strength and power, 6-minute walk test, functional leg power, and habitual walking behavior (average daily steps, minutes per week of moderate to vigorous physical activity', 'muscle strength and power, functional performance, and physical activity behavior']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0205353', 'cui_str': 'Habitual (qualifier value)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0427052', 'cui_str': 'Finding of power of skeletal muscle'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0430515', 'cui_str': '6-Minute Walk Test'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0205353', 'cui_str': 'Habitual (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C3853978'}]",12.0,0.0165304,There were no differences between the groups for amount of change on the outcome measures the authors selected.,"[{'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Trudelle-Jackson', 'Affiliation': ''}, {'ForeName': 'Emerenciana', 'Initials': 'E', 'LastName': 'Hines', 'Affiliation': ''}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Medley', 'Affiliation': ''}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Thompson', 'Affiliation': ''}]",Journal of physical activity & health,['10.1123/jpah.2019-0233']
3609,31990328,Changes in physical activity of adolescent girls in the context of their perception of the Healthy Me programme.,"BACKGROUND


An assumption was made that results of programme evaluation lead to better understanding for whom this intervention may work. The aim of the article is to compare the changes in physical activity of the intervention programme participants depending on subjective assessment of its impact.
METHODS


The data were obtained from 14- to15-year-old Polish girls (N = 1120) from 48 random selected secondary schools participating in the 1-year Healthy Me programme in the 2017/2018. Schools were randomly assigned to one of two types of intervention or to a control (null) group. Satisfaction with the programme according to 21 criteria was measured retrospectively just after the intervention. Change in MVPA (moderate-to-vigorous physical activity) during the programme implementation was assessed in relation to satisfaction level, and adjusted for initial MVPA.
RESULTS


In total, the MVPA did not change significantly comparing pre- and post-intervention surveys (3.94 ± 1.94 vs. 3.87 ± 1.93)-P = 0.093. However, the perceived notable improvement of functioning in 10 out of 21 areas was related to the unquestionable increase in MVPA (P ≤ 0.001). With respect to the four impact areas, an interaction was demonstrated between an intervention group and an improvement in the domain-specific functioning. The beneficial impact of the programme on these areas was associated with the improvement of physical activity only in case of full and null intervention.
CONCLUSIONS


Indicators related to the implementation process and the results obtained during the Healthy Me programme evaluation could represent a change in motivational and environmental factors that indirectly affects adolescent girl's physical activity.",2020,"The beneficial impact of the programme on these areas was associated with the improvement of physical activity only in case of full and null intervention.
","['14- to15-year-old Polish girls (N\u2009=\u20091120) from 48 random selected secondary schools participating in the 1-year Healthy Me programme in the 2017/2018', 'adolescent girls']",[],"['MVPA', 'physical activity']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0032377', 'cui_str': 'Polishes'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0036530', 'cui_str': 'Schools, Secondary'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]",[],"[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",,0.0196041,"The beneficial impact of the programme on these areas was associated with the improvement of physical activity only in case of full and null intervention.
","[{'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Mazur', 'Affiliation': 'Department of Humanization in Medicine and Sexology, University of Zielona Gora, Collegium Medicum, Zielona Gora, Poland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Dzielska', 'Affiliation': 'Department of Child and Adolescent Health, Institute of Mother and Child, Warsaw, Poland.'}, {'ForeName': 'Dorota', 'Initials': 'D', 'LastName': 'Kleszczewska', 'Affiliation': 'Foundation of the Institute of Mother and Child, Warsaw, Poland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Oblacińska', 'Affiliation': 'Department of Child and Adolescent Health, Institute of Mother and Child, Warsaw, Poland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Fijałkowska', 'Affiliation': 'Department of Cardiology, Institute of Mother and Child, Warsaw, Poland.'}]",European journal of public health,['10.1093/eurpub/ckz242']
3610,32016111,Assessment of the Effectiveness of Pelvic Floor Muscle Training (PFMT) and Extracorporeal Magnetic Innervation (ExMI) in Treatment of Stress Urinary Incontinence in Women: A Randomized Controlled Trial.,"Objective


The purpose of this study is to assess the effectiveness of pelvic floor muscle training and extracorporeal magnetic innervation in treatment of urinary incontinence in women with stress urinary incontinence.
Methods


The randomized controlled trial enrolled 128 women with stress urinary incontinence who were randomly allocated to either one out of two experimental groups (EG1 or EG2) or the control group (CG). Subjects in the experimental group 1 (EG1) received 12 sessions of pelvic floor muscle training, whereas subjects in the experimental group 2 (EG2) received 12 sessions of extracorporeal magnetic innervation. Subjects in the control group (CG) did not receive any therapeutic intervention. The following instruments were used to measure results in all study groups at the initial and final assessments: Revised Urinary Incontinence Scale (RUIS), Beck Depression Inventory (BDI-II), General Self-Efficacy Scale (GSES), and King's Health Questionnaire (KHQ).
Results


In both experimental groups, a statistically significant decline in depressive symptoms (BDI-II) and an improvement in urinary incontinence severity (RUIS) and quality of life (KHQ) were found in the following domains: ""social limitations,"" ""emotions,"" ""severity measures,"" and ""symptom severity scale."" Moreover, self-efficacy beliefs (GSES) improved in the experimental group that received ExMI (EG2). No statistically significant differences were found between all measured variables in the control group. Comparative analysis of the three study groups showed statistically significant differences at the final assessment in the quality of life in the following domains: ""physical limitations,"" ""social limitations,"" ""personal relationships,"" and ""emotions.""  Conclusion . Pelvic floor muscle training and extracorporeal magnetic innervation proved to be effective treatment methods for stress urinary incontinence in women. The authors observed an improvement in both the physical and psychosocial aspects.",2020,"Moreover, self-efficacy beliefs (GSES) improved in the experimental group that received ExMI (EG2).","['Stress Urinary Incontinence in Women', 'stress urinary incontinence in women', '128 women with stress urinary incontinence', 'women with stress urinary incontinence']","['ExMI (EG2', 'pelvic floor muscle training, whereas subjects in the experimental group 2 (EG2) received 12 sessions of extracorporeal magnetic innervation', 'Pelvic Floor Muscle Training (PFMT) and Extracorporeal Magnetic Innervation (ExMI', 'pelvic floor muscle training and extracorporeal magnetic innervation', 'control group (CG', 'Pelvic floor muscle training and extracorporeal magnetic innervation']","['quality of life', ""Urinary Incontinence Scale (RUIS), Beck Depression Inventory (BDI-II), General Self-Efficacy Scale (GSES), and King's Health Questionnaire (KHQ"", 'urinary incontinence', 'urinary incontinence severity (RUIS) and quality of life (KHQ', 'self-efficacy beliefs (GSES', 'depressive symptoms (BDI-II', 'social limitations,"" ""emotions,"" ""severity measures,"" and ""symptom severity scale']","[{'cui': 'C0042025', 'cui_str': 'Urinary Stress Incontinence'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0442087', 'cui_str': 'Extracorporeal (qualifier value)'}, {'cui': 'C0024488', 'cui_str': 'Magnetics'}, {'cui': 'C1619351', 'cui_str': 'nerve supply'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0034380'}, {'cui': 'C0042024', 'cui_str': 'Urinary Incontinence'}, {'cui': 'C0222045'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0449295', 'cui_str': 'Limitation (attribute)'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}]",128.0,0.0216735,"Moreover, self-efficacy beliefs (GSES) improved in the experimental group that received ExMI (EG2).","[{'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Weber-Rajek', 'Affiliation': 'Department of Physiotherapy, Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University, Torun, Poland.'}, {'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Strączyńska', 'Affiliation': 'Department of Physiotherapy, Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University, Torun, Poland.'}, {'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Strojek', 'Affiliation': 'Department of Physiotherapy, Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University, Torun, Poland.'}, {'ForeName': 'Zuzanna', 'Initials': 'Z', 'LastName': 'Piekorz', 'Affiliation': 'Department of Physiotherapy, Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University, Torun, Poland.'}, {'ForeName': 'Beata', 'Initials': 'B', 'LastName': 'Pilarska', 'Affiliation': 'Clinic of Urology, Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University, Torun, Poland.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Podhorecka', 'Affiliation': 'Department of Geriatrics, Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University, Torun, Poland.'}, {'ForeName': 'Kinga', 'Initials': 'K', 'LastName': 'Sobieralska-Michalak', 'Affiliation': 'Clinic of Rehabilitation, 10th Military Research Hospital and Polyclinic, Bydgoszcz, Poland.'}, {'ForeName': 'Aleksander', 'Initials': 'A', 'LastName': 'Goch', 'Affiliation': 'Department of Physiotherapy, Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University, Torun, Poland.'}, {'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Radzimińska', 'Affiliation': 'Department of Physiotherapy, Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University, Torun, Poland.'}]",BioMed research international,['10.1155/2020/1019872']
3611,32020356,Exercise is more effective than health education in reducing fatigue in fatigued cancer survivors.,"INTRODUCTION


Cancer-related fatigue is a most debilitating side effect reported by survivors, often lasting years following treatment.
PURPOSE


To determine the effects of a 10-week exercise intervention compared with a health education intervention on fatigue, quality of life outcomes and functional fitness in cancer survivors with documented fatigue.
METHODS


This quasi-experimental study allocated 37 post-treatment fatigued cancer survivors (33 female, 30 breast cancer, aged 55 ± 2 years, time since treatment 2.3 ± 0.3 years; mean ± SEM) to an exercise group (EX, n = 19) or health education comparison group (HE, n = 18). The EX intervention emphasised brisk walking with progressive increments, stretching, exercise education and self-efficacy enhancement. The HE intervention emphasised sleep management, nutrition and cognitive behavioural therapy. All participants were evaluated at pre- and post-intervention with EX followed up at 26 W.
RESULTS


The intervention effect on fatigue (FACT-F) in EX was greater (p < 0.05) than that in HE, the difference being 4 times the recognised clinically important difference. The intervention also increased (p < 0.05) cognitive function, global quality of life and functional fitness scores. It reduced (p < 0.05) insomnia and fear of physical activity. All intervention effects were maintained to 26 W. The intervention effect on fatigue in EX was largely achieved by week 4. There was 100% retention rate at 10 W and no adverse events reported.
CONCLUSIONS


There is a reduction of considerable magnitude in cancer fatigue from group-based exercise training, that is sustainable and attributable to exercise per se.
IMPLICATIONS FOR CANCER SURVIVORS


Exercise training is feasible for fatigued cancer survivors and should form part of tailored rehabilitation programmes.",2020,"The intervention effect on fatigue (FACT-F) in EX was greater (p < 0.05) than that in HE, the difference being 4 times the recognised clinically important difference.","['fatigued cancer survivors', '37 post-treatment fatigued cancer survivors (33 female, 30 breast cancer, aged 55\u2009±\u20092\xa0years, time since treatment 2.3\u2009±\u20090.3\xa0years; mean ± SEM) to an exercise group (EX, n\u2009=\u200919) or health education comparison group (HE, n\u2009=\u200918', 'cancer survivors with documented fatigue']","['exercise intervention', 'Exercise training', 'Exercise', 'health education intervention']","['fatigue, quality of life outcomes and functional fitness', 'insomnia and fear of physical activity', 'retention rate', 'fatigue (FACT-F) in EX', 'cognitive function, global quality of life and functional fitness scores', 'fatigue in EX']","[{'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C4068885', 'cui_str': 'Zero point three'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0018701'}, {'cui': 'C1301725', 'cui_str': 'Documented'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0018701'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0034380'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0264832,"The intervention effect on fatigue (FACT-F) in EX was greater (p < 0.05) than that in HE, the difference being 4 times the recognised clinically important difference.","[{'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Sheehan', 'Affiliation': 'Department of Sport and Exercise Science, Waterford Institute of Technology, Cork Road, Waterford, Ireland.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Denieffe', 'Affiliation': 'School of Humanities, Waterford Institute of Technology, Cork Road, Waterford, Ireland.'}, {'ForeName': 'Niamh M', 'Initials': 'NM', 'LastName': 'Murphy', 'Affiliation': 'Department of Sport and Exercise Science, Waterford Institute of Technology, Cork Road, Waterford, Ireland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Harrison', 'Affiliation': 'Department of Sport and Exercise Science, Waterford Institute of Technology, Cork Road, Waterford, Ireland. mharrison@wit.ie.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-020-05328-w']
3612,30954363,Clinical outcome and cost-effectiveness of a 1-year nutritional intervention programme in COPD patients with low muscle mass: The randomized controlled NUTRAIN trial.,"BACKGROUND AND AIMS


The efficacy of nutritional intervention to enhance short- and long-term outcomes of pulmonary rehabilitation in COPD is still unclear, hence this paper aims to investigate the clinical outcome and cost-effectiveness of a 12-month nutritional intervention strategy in muscle-wasted COPD patients.
METHODS


Prior to a 4-month pulmonary rehabilitation programme, 81 muscle-wasted COPD patients (51% males, aged 62.5 ± 0.9 years) with moderate airflow obstruction (FEV 1  55.1 ± 2.2% predicted) and impaired exercise capacity (W max  63.5 ± 2.4% predicted) were randomized to 3 portions of nutritional supplementation per day (enriched with leucine, vitamin D and polyunsaturated fatty acids) [NUTRITION] or PLACEBO (phase 1). In the unblinded 8-month maintenance phase (phase 2), both groups received structured feedback on their physical activity level assessed by accelerometry. NUTRITION additionally received 1 portion of supplemental nutrition per day and motivational interviewing-based nutritional counselling. A 3-month follow-up (phase 3) was included.
RESULTS


After 12 months, physical capacity measured by quadriceps muscle strength and cycle endurance time were not different, but physical activity was higher in NUTRITION than in PLACEBO (Δ1030 steps/day, p = 0.025). Plasma levels of the enriched nutrients (p < 0.001) were higher in NUTRITION than PLACEBO. Trends towards weight gain in NUTRITION and weight loss in PLACEBO led to a significant between-group difference after 12 months (Δ1.54 kg, p = 0.041). The HADS anxiety and depression scores improved in NUTRITION only (Δ-1.92 points, p = 0.037). Generic quality of life (EQ-5D) was decreased in PLACEBO but not in NUTRITION (between-group difference after 15 months 0.072 points, p = 0.009). Overall motivation towards exercising and healthy eating was high and did not change significantly after 12 months; only amotivation towards healthy eating yielded a significant between-group difference (Δ1.022 points, p = 0.015). The cost per quality-adjusted life-year after 15 months was EUR 16,750.
CONCLUSIONS


Nutritional intervention in muscle-wasted patients with moderate COPD does not enhance long-term outcome of exercise training on physical capacity but ameliorates plasma levels of the supplemented nutrients, total body weight, physical activity and generic health status, at an acceptable increase of costs for patients with high disease burden.",2020,"Overall motivation towards exercising and healthy eating was high and did not change significantly after 12 months; only amotivation towards healthy eating yielded a significant between-group difference (Δ1.022 points, p = 0.015).","['patients with high disease burden', 'muscle-wasted patients with moderate COPD', 'COPD patients with low muscle mass', 'muscle-wasted COPD patients', '81 muscle-wasted COPD patients (51% males, aged 62.5\xa0±\xa00.9 years) with moderate airflow obstruction (FEV 1  55.1\xa0±\xa02.2% predicted) and impaired exercise capacity (W max  63.5\xa0±\xa02.4% predicted']","['nutritional intervention programme', 'supplemental nutrition per day and motivational interviewing-based nutritional counselling', 'exercise training', 'nutritional supplementation per day (enriched with leucine, vitamin D and polyunsaturated fatty acids) [NUTRITION] or PLACEBO', 'nutritional intervention', 'structured feedback on their physical activity level assessed by accelerometry']","['physical capacity measured by quadriceps muscle strength and cycle endurance time', 'total body weight, physical activity and generic health status', 'HADS anxiety and depression scores', 'weight gain in NUTRITION and weight loss', 'Generic quality of life (EQ-5D', 'Plasma levels', 'Clinical outcome and cost-effectiveness', 'physical activity', 'Overall motivation towards exercising and healthy eating']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0856558', 'cui_str': 'Muscle wasting (disuse)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle (finding)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C4517836', 'cui_str': '62.5'}, {'cui': 'C4068881', 'cui_str': 'Zero point nine'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0231999', 'cui_str': 'Airflow, function (observable entity)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C4517631', 'cui_str': '2.4 (qualifier value)'}]","[{'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0683474', 'cui_str': 'Motivational Interviewing'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplement'}, {'cui': 'C0023401', 'cui_str': 'L-leucine'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0032615', 'cui_str': 'Polyunsaturated Fatty Acids'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0441677', 'cui_str': 'Accelerometry'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0034380'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0452415', 'cui_str': 'Healthy Diet'}]",,0.110496,"Overall motivation towards exercising and healthy eating was high and did not change significantly after 12 months; only amotivation towards healthy eating yielded a significant between-group difference (Δ1.022 points, p = 0.015).","[{'ForeName': 'Martijn', 'Initials': 'M', 'LastName': 'van Beers', 'Affiliation': 'Department of Respiratory Medicine, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Maureen P M H', 'Initials': 'MPMH', 'LastName': 'Rutten-van Mölken', 'Affiliation': 'Institute of Health Care Policy and Management/Institute of Medical Technology Assessment, Erasmus University Rotterdam, Rotterdam, the Netherlands.'}, {'ForeName': 'Coby', 'Initials': 'C', 'LastName': 'van de Bool', 'Affiliation': 'Department of Respiratory Medicine, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Melinde', 'Initials': 'M', 'LastName': 'Boland', 'Affiliation': 'Institute of Health Care Policy and Management/Institute of Medical Technology Assessment, Erasmus University Rotterdam, Rotterdam, the Netherlands.'}, {'ForeName': 'Stef P J', 'Initials': 'SPJ', 'LastName': 'Kremers', 'Affiliation': 'Department of Health Promotion, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Frits M E', 'Initials': 'FME', 'LastName': 'Franssen', 'Affiliation': 'Department of Respiratory Medicine, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre, Maastricht, the Netherlands; CIRO, Center of Expertise for Chronic Organ Failure, Horn, the Netherlands.'}, {'ForeName': 'Ardy', 'Initials': 'A', 'LastName': 'van Helvoort', 'Affiliation': 'Department of Respiratory Medicine, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre, Maastricht, the Netherlands; Nutricia Research, Nutricia Advanced Medical Nutrition, Utrecht, the Netherlands.'}, {'ForeName': 'Harry R', 'Initials': 'HR', 'LastName': 'Gosker', 'Affiliation': 'Department of Respiratory Medicine, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Emiel F', 'Initials': 'EF', 'LastName': 'Wouters', 'Affiliation': 'Department of Respiratory Medicine, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre, Maastricht, the Netherlands; CIRO, Center of Expertise for Chronic Organ Failure, Horn, the Netherlands.'}, {'ForeName': 'Annemie M W J', 'Initials': 'AMWJ', 'LastName': 'Schols', 'Affiliation': 'Department of Respiratory Medicine, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre, Maastricht, the Netherlands. Electronic address: a.schols@maastrichtuniversity.nl.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2019.03.001']
3613,31994752,Advanced decision-making using patient-reported outcome measures in total joint replacement.,"Up to one-third of total joint replacement (TJR) procedures may be performed inappropriately in a subset of patients who remain dissatisfied with their outcomes, stressing the importance of shared decision-making. Patient-reported outcome measures capture physical, emotional, and social aspects of health and wellbeing from the patient's perspective. Powerful computer systems capable of performing highly sophisticated analysis using different types of data, including patient-derived data, such as patient-reported outcomes, may eliminate guess work, generating impactful metrics to better inform the decision-making process. We have created a shared decision-making tool which generates personalized predictions of risks and benefits from TJR based on patient-reported outcomes as well as clinical and demographic data. We present the protocol for a randomized controlled trial designed to assess the impact of this tool on decision quality, level of shared decision-making, and patient and process outcomes. We also discuss current concepts in this field and highlight opportunities leveraging patient-reported data and artificial intelligence for decision support across the care continuum.",2020,"Powerful computer systems capable of performing highly sophisticated analysis using different types of data, including patient-derived data, such as patient-reported outcomes, may eliminate guess work, generating impactful metrics to better inform the decision making process.",[],['total joint replacement (TJR) procedures'],"['capture physical, emotional and social aspects of health and wellbeing', 'Total Joint Replacement']",[],"[{'cui': 'C4279925', 'cui_str': 'Total Joint Replacement'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C4279925', 'cui_str': 'Total Joint Replacement'}]",,0.0738654,"Powerful computer systems capable of performing highly sophisticated analysis using different types of data, including patient-derived data, such as patient-reported outcomes, may eliminate guess work, generating impactful metrics to better inform the decision making process.","[{'ForeName': 'Prakash', 'Initials': 'P', 'LastName': 'Jayakumar', 'Affiliation': 'Department of Surgery and Perioperative Care, Dell Medical School, University of Texas at Austin, Austin, Texas.'}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Bozic', 'Affiliation': 'Department of Surgery and Perioperative Care, Dell Medical School, University of Texas at Austin, Austin, Texas.'}]",Journal of orthopaedic research : official publication of the Orthopaedic Research Society,['10.1002/jor.24614']
3614,31839012,The effectiveness of Nurture and Play: a mentalisation-based parenting group intervention for prenatally depressed mothers.,"AIM


This randomised control trial (RCT) study examined the effectiveness of a mentalisation-based perinatal group intervention, Nurture and Play (NaP), in improving mother-infant interaction quality and maternal reflective functioning and in decreasing depressive symptoms.
BACKGROUND


Few preventive prenatal interventions have been developed for primary health care settings for mothers with depressive symptoms. Furthermore, previous prenatal intervention studies have only concentrated on reducing depressive symptoms and have not directly addressed enhancing optimal parenting qualities.
METHODS


The participants were 45 pregnant women with depressive symptoms. Women in the randomly assigned intervention group (n = 24) participated in the manualised, short-term NaP intervention group from pregnancy until the baby's age of seven months, whereas control group women received treatment as usual (TAU). Maternal emotional availability (EA), reflective functioning (RF) and depressive symptoms were measured before the intervention and at the infants' 12 months of age, and changes were evaluated using repeated measure analyses of variances (ANOVAs).
FINDINGS


The results showed that the intervention group displayed higher maternal sensitivity and RF and more reduction in depressive symptoms than the control group when babies were 12 months old. These findings provide preliminary support for the effectiveness of the NaP intervention.",2019,The results showed that the intervention group displayed higher maternal sensitivity and RF and more reduction in depressive symptoms than the control group when babies were 12 months old.,"['45 pregnant women with depressive symptoms', 'prenatally depressed mothers', 'mothers with depressive symptoms']","['Nurture and Play: a mentalisation-based parenting group intervention', 'mentalisation-based perinatal group intervention, Nurture and Play (NaP', 'manualised, short-term NaP intervention', 'control group women received treatment as usual (TAU']","['maternal sensitivity and RF', 'Maternal emotional availability (EA), reflective functioning (RF) and depressive symptoms', 'depressive symptoms']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}]","[{'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0067518', 'cui_str': 'NAPS'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1720655', 'cui_str': 'Tau'}]","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}]",45.0,0.0897034,The results showed that the intervention group displayed higher maternal sensitivity and RF and more reduction in depressive symptoms than the control group when babies were 12 months old.,"[{'ForeName': 'S J', 'Initials': 'SJ', 'LastName': 'Salo', 'Affiliation': 'Helsinki University, Helsinki, Finland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Flykt', 'Affiliation': 'Tampere University, Helsinki, Finland.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Mäkelä', 'Affiliation': 'National Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Biringen', 'Affiliation': 'Colorado State University, US.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kalland', 'Affiliation': 'Helsinki University, Helsinki, Finland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Pajulo', 'Affiliation': 'Turku University, Helsinki, Finland.'}, {'ForeName': 'R L', 'Initials': 'RL', 'LastName': 'Punamäki', 'Affiliation': 'Tampere University, Helsinki, Finland.'}]",Primary health care research & development,['10.1017/S1463423619000914']
3615,32016702,Exercise to Reduce Mobility Disability and Prevent Falls After Fall-Related Leg or Pelvic Fracture: RESTORE Randomized Controlled Trial.,"BACKGROUND


Disability and falls are common following fall-related lower limb and pelvic fractures.
OBJECTIVE


To evaluate the impact of an exercise self-management intervention on mobility-related disability and falls after lower limb or pelvic fracture.
DESIGN


Randomized controlled trial.
PARTICIPANTS


Three hundred thirty-six community dwellers aged 60+ years within 2 years of lower limb or pelvic fracture recruited from hospitals and community advertising.
INTERVENTIONS


RESTORE (Recovery Exercises and STepping On afteR fracturE) intervention (individualized, physiotherapist-prescribed home program of weight-bearing balance and strength exercises, fall prevention advice) versus usual care.
MAIN MEASURES


Primary outcomes were mobility-related disability and rate of falls.
KEY RESULTS


Primary outcomes were available for 80% of randomized participants. There were no significant between-group differences in mobility-related disability at 12 months measured by (a) Short Physical Performance Battery (continuous version, baseline-adjusted between-group difference 0.08, 95% CI - 0.01 to 0.17, p = 0.08, n = 273); (b) Activity Measure Post Acute Care score (0.18, 95% CI - 2.89 to 3.26, p = 0.91, n = 270); (c) Late Life Disability Instrument (1.37, 95% CI - 2.56 to 5.32, p = 0.49, n = 273); or in rate of falls over the 12-month study period (incidence rate ratio 0.96, 95% CI 0.69 to 1.34, n = 336, p = 0.83). Between-group differences favoring the intervention group were evident in some secondary outcomes: balance and mobility, fall risk (Physiological Profile Assessment tool), physical activity, mood, health and community outings, but these should be interpreted with caution due to risk of chance findings from multiple analyses.
CONCLUSIONS


No statistically significant intervention impacts on mobility-related disability and falls were detected, but benefits were seen for secondary measures of balance and mobility, fall risk, physical activity, mood, health, and community outings.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry: ACTRN12610000805077.",2020,"There were no significant between-group differences in mobility-related disability at 12 months measured by (a) Short Physical Performance Battery (continuous version, baseline-adjusted between-group difference 0.08, 95% CI - 0.01 to 0.17, p = 0.08, n = 273); (b) Activity Measure Post Acute Care score (0.18, 95% CI - 2.89 to 3.26, p = 0.91, n = 270); (c)","['Australian New Zealand Clinical Trials Registry', 'Three hundred thirty-six community dwellers aged 60+ years within 2\xa0years of lower limb or pelvic fracture recruited from hospitals and community advertising', 'After Fall-Related Leg or Pelvic Fracture']","['afteR fracturE) intervention (individualized, physiotherapist-prescribed home program of weight-bearing balance and strength exercises, fall prevention advice) versus usual care', 'exercise self-management intervention', 'Recovery Exercises and STepping On']","['rate of falls', 'secondary outcomes: balance and mobility, fall risk (Physiological Profile Assessment tool), physical activity, mood, health and community outings', 'mobility-related disability and rate of falls', 'mobility-related disability', 'Activity Measure Post Acute Care score', 'balance and mobility, fall risk, physical activity, mood, health, and community outings', 'Short Physical Performance Battery (continuous version', 'Late Life Disability Instrument', 'Mobility Disability and Prevent Falls', 'mobility-related disability and falls']","[{'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C4319606', 'cui_str': 'Thirty-six'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0149531', 'cui_str': 'Pelvic fracture'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0000921', 'cui_str': 'Falls'}]","[{'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapists'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0085086', 'cui_str': 'Finding of weight-bearing'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0150223', 'cui_str': 'Fall prevention (procedure)'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C1261552', 'cui_str': 'Step'}]","[{'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C1268740', 'cui_str': 'Fall risk'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0376635', 'cui_str': 'Post-acute Care'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C4551823', 'cui_str': 'instruments'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}]",336.0,0.139896,"There were no significant between-group differences in mobility-related disability at 12 months measured by (a) Short Physical Performance Battery (continuous version, baseline-adjusted between-group difference 0.08, 95% CI - 0.01 to 0.17, p = 0.08, n = 273); (b) Activity Measure Post Acute Care score (0.18, 95% CI - 2.89 to 3.26, p = 0.91, n = 270); (c)","[{'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Sherrington', 'Affiliation': 'Institute for Musculoskeletal Health, School of Public Health, University of Sydney, Sydney, NSW, Australia. cathie.sherrington@sydney.edu.au.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Fairhall', 'Affiliation': 'Institute for Musculoskeletal Health, School of Public Health, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Kirkham', 'Affiliation': 'Institute for Musculoskeletal Health, School of Public Health, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Lindy', 'Initials': 'L', 'LastName': 'Clemson', 'Affiliation': 'Faculty of Health Sciences, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Tiedemann', 'Affiliation': 'Institute for Musculoskeletal Health, School of Public Health, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Constance', 'Initials': 'C', 'LastName': 'Vogler', 'Affiliation': 'Northern Clinical School, Sydney Medical School, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Jacqueline C T', 'Initials': 'JCT', 'LastName': 'Close', 'Affiliation': 'Prince of Wales Clinical School, University of New South Wales, Randwick, NSW, Australia.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': ""O'Rourke"", 'Affiliation': 'Institute for Musculoskeletal Health, School of Public Health, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Moseley', 'Affiliation': 'Institute for Musculoskeletal Health, School of Public Health, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Ian D', 'Initials': 'ID', 'LastName': 'Cameron', 'Affiliation': 'John Walsh Centre for Rehabilitation Research, Kolling Institute, Faculty of Medicine and Health, The University of Sydney, St Leonards, NSW, Australia.'}, {'ForeName': 'Jenson C S', 'Initials': 'JCS', 'LastName': 'Mak', 'Affiliation': 'John Walsh Centre for Rehabilitation Research, Kolling Institute, Faculty of Medicine and Health, The University of Sydney, St Leonards, NSW, Australia.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Lord', 'Affiliation': 'Neuroscience Research Australia, University of New South Wales, Randwick, NSW, Australia.'}]",Journal of general internal medicine,['10.1007/s11606-020-05666-9']
3616,30203677,"Physical Activity Maintenance Following Home-Based, Individually Tailored Print Interventions for African American Women.","African American women report low participation in physical activity and are disproportionately burdened by related conditions (obesity, breast, and colon cancer). Physical activity interventions have shown promising results among African American women, but most studies in this area have focused on short-term increases. More enduring changes in health behavior will be needed to eliminate existing health disparities. Thus, the current study examined 12-month physical activity and psychosocial outcomes from a pilot randomized controlled trial ( N  = 84) of a Home-based Individually tailored Physical activity Print (HIPP) intervention for African American women in the Deep South. Retention was 77.4% at 12 months. HIPP participants increased self-reported moderate-to-vigorous physical activity from 35.1 minutes/week (standard deviation  [SD]  = 47.8) at baseline to 124 minutes/week ( SD  = 95.5) at 12 months, compared with the wellness contact control participants who reported increases from 48.2 minutes/week ( SD  = 51.3) to 102.5 minutes/week ( SD  = 94.5) over 12 months (between-group  p  > .05). Results indicate that modest improvements in moderate-to-vigorous physical activity and related psychosocial variables occurred during the active intervention phase (months 0-6) and were sustained during the tapered maintenance period (months 6-12). Low-cost, high-reach, home-based strategies have great potential for supporting sustained participation in physical activity and achieving long-term health benefits among African American women in the Deep South.",2020,"HIPP participants increased self-reported moderate-to-vigorous physical activity from 35.1 minutes/week (standard deviation [SD] = 47.8) at baseline to 124 minutes/week ( SD = 95.5) at 12 months, compared with the wellness contact control participants who reported increases from 48.2 minutes/week ( SD = 51.3) to 102.5 minutes/week ( SD = 94.5) over 12 months (between-group p > .05).","['African American women in the Deep South', 'African American women', 'African American Women']","['HIPP', 'Home-based Individually tailored Physical activity Print (HIPP) intervention', 'Physical activity interventions']","['moderate-to-vigorous physical activity and related psychosocial variables', 'Physical Activity Maintenance', 'self-reported moderate-to-vigorous physical activity']","[{'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}]",,0.0232658,"HIPP participants increased self-reported moderate-to-vigorous physical activity from 35.1 minutes/week (standard deviation [SD] = 47.8) at baseline to 124 minutes/week ( SD = 95.5) at 12 months, compared with the wellness contact control participants who reported increases from 48.2 minutes/week ( SD = 51.3) to 102.5 minutes/week ( SD = 94.5) over 12 months (between-group p > .05).","[{'ForeName': 'Dori', 'Initials': 'D', 'LastName': 'Pekmezi', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Cole', 'Initials': 'C', 'LastName': 'Ainsworth', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Desmond', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Pisu', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Williams', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Kaiying', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Taylor', 'Initials': 'T', 'LastName': 'Holly', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Meneses', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Bess', 'Initials': 'B', 'LastName': 'Marcus', 'Affiliation': 'Brown University, Providence, RI, USA.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Demark-Wahnefried', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, AL, USA.'}]",Health promotion practice,['10.1177/1524839918798819']
3617,31837113,Safety and effectiveness of lurasidone for the treatment of schizophrenia in Asian patients: Results of a 26-week open-label extension study.,"INTRODUCTION


This study was designed to evaluate the long-term safety and effectiveness of lurasidone in the treatment of schizophrenia among Asian patients.
METHODS


Patients (N = 281) with schizophrenia who had completed a randomized, double-blind (DB), 6-week comparison of lurasidone (40 and 80 mg/day) and placebo were enrolled in a 26-week extension study in which all patients received open-label (OL), flexible doses of lurasidone (40 or 80 mg/day). Effectiveness was measured using the Positive and Negative Syndrome Scale (PANSS) scale.
RESULTS


Fifty-seven percent of patients completed the OL extension study; 16.7% discontinued early due to lack of effectiveness; and 10.3% due to adverse events. The most common adverse events were insomnia (11.3%), akathisia (11.0%), and nasopharyngitis (10.6%). Adverse events related to weight gain, metabolic parameters, prolactin, and ECG measures were uncommon. Mean change in the PANSS total score from the DB baseline to OL endpoint was -28.4, with mean improvement of -7.5 observed from baseline to OL endpoint, and with a PANSS responder rate of 73.7%.
DISCUSSION


The results of the current 26-week extension study found lurasidone to be a generally safe, well-tolerated, and effective long-term treatment for schizophrenia in Asian patients.",2020,"The most common adverse events were insomnia (11.3%), akathisia (11.0%), and nasopharyngitis (10.6%).","['schizophrenia among Asian patients', 'Patients (N = 281) with schizophrenia who had completed a randomized, double-blind (DB), 6-week comparison of', 'Asian patients', 'schizophrenia in Asian patients']","['lurasidone (40 and 80 mg/day) and placebo', 'open-label (OL), flexible doses of lurasidone', 'lurasidone']","['Safety and effectiveness', 'akathisia', 'nasopharyngitis', 'Positive and Negative Syndrome Scale (PANSS) scale', 'weight gain, metabolic parameters, prolactin, and ECG measures', 'adverse events']","[{'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C2003424', 'cui_str': 'lurasidone'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0443220', 'cui_str': 'Flexible (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0392156', 'cui_str': 'Akathisia'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale (assessment scale)'}, {'cui': 'C0222045'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0033371', 'cui_str': 'Prolactin'}, {'cui': 'C1623258', 'cui_str': 'ECG'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0580766,"The most common adverse events were insomnia (11.3%), akathisia (11.0%), and nasopharyngitis (10.6%).","[{'ForeName': 'Teruhiko', 'Initials': 'T', 'LastName': 'Higuchi', 'Affiliation': 'Japan Depression Center, Tokyo, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Ishigooka', 'Affiliation': 'Institute of CNS Pharmacology, Tokyo, Japan.'}, {'ForeName': 'Masaomi', 'Initials': 'M', 'LastName': 'Iyo', 'Affiliation': 'Department of Psychiatry, National University Corporation Chiba University, Graduate School of Medicine, Chiba, Japan.'}, {'ForeName': 'Katsuhiko', 'Initials': 'K', 'LastName': 'Hagi', 'Affiliation': 'Sumitomo Dainippon Pharma Co., Ltd., Tokyo, Japan.'}]",Asia-Pacific psychiatry : official journal of the Pacific Rim College of Psychiatrists,['10.1111/appy.12377']
3618,32015256,Mobile Electrocardiogram Monitoring and Health-Related Quality of Life in Patients With Atrial Fibrillation: Findings From the iPhone Helping Evaluate Atrial Fibrillation Rhythm Through Technology (iHEART) Study.,"BACKGROUND


Atrial fibrillation (AF) is associated with high recurrence rates and poor health-related quality of life (HRQOL) but few effective interventions to improve HRQOL exist.
OBJECTIVE


The aim of this study was to examine the impact of the ""iPhone Helping Evaluate Atrial Fibrillation Rhythm through Technology"" (iHEART) intervention on HRQOL in patients with AF.
METHODS


We randomized English- and Spanish-speaking adult patients with AF to receive either the iHEART intervention or usual care for 6 months. The iHEART intervention used smartphone-based electrocardiogram monitoring and motivational text messages. Three instruments were used to measure HRQOL: the Atrial Fibrillation Effect on Quality of Life (AFEQT), the 36-item Short-Form Health survey, and the EuroQol-5D. We used linear mixed models to compare the effect of the iHEART intervention on HRQOL, quality-adjusted life-years, and AF symptom severity.
RESULTS


A total of 238 participants were randomized to the iHEART intervention (n = 115) or usual care (n = 123). Of the participants, 77% were men and 76% were white. More than half (55%) had an AF recurrence. Both arms had improved scores from baseline to follow-up for AFEQT and AF symptom severity scores. The global AFEQT score improved 18.5 and 11.2 points in the intervention and control arms, respectively (P < .05). There were no statistically significant differences in HRQOL, quality-adjusted life-years, or AF symptom severity between groups.
CONCLUSIONS


We found clinically meaningful improvements in AF-specific HRQOL and AF symptom severity for both groups. Additional research with longer follow-up should examine the influence of smartphone-based interventions for AF management on HRQOL and address the unique needs of patients diagnosed with different subtypes of AF.",2020,"The global AFEQT score improved 18.5 and 11.2 points in the intervention and control arms, respectively (P < .05).","['Patients With Atrial Fibrillation', '238 participants', 'Spanish-speaking adult patients with AF to receive either the', 'n = 115) or usual care (n = 123', 'Of the participants, 77% were men and 76% were white', 'patients with AF']","['iHEART intervention', 'Technology"" (iHEART) intervention', 'smartphone-based electrocardiogram monitoring and motivational text messages', 'iHEART intervention or usual care for 6 months']","['HRQOL, quality-adjusted life-years, and AF symptom severity', 'AF recurrence', 'Mobile Electrocardiogram Monitoring and Health-Related Quality of Life', 'global AFEQT score', 'HRQOL, quality-adjusted life-years, or AF symptom severity', 'AF-specific HRQOL and AF symptom severity', 'HRQOL: the Atrial Fibrillation Effect on Quality of Life (AFEQT), the 36-item Short-Form Health survey, and the EuroQol-5D']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C3161473', 'cui_str': 'Spaniards (ethnic group)'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517540', 'cui_str': '115 (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043157', 'cui_str': 'Whites'}]","[{'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}]",238.0,0.0718041,"The global AFEQT score improved 18.5 and 11.2 points in the intervention and control arms, respectively (P < .05).","[{'ForeName': 'Billy A', 'Initials': 'BA', 'LastName': 'Caceres', 'Affiliation': 'Billy A. Caceres, PhD, RN, AGPCNP-BC Assistant Professor, Columbia University School of Nursing, New York, New York. Kathleen T. Hickey, EdD, FNP, ANP, FAHA, FAAN Professor of Nursing, Columbia University School of Nursing, New York, New York. Suzanne B. Bakken, PhD, RN, FAAN, FACMI Professor of Biomedical Informatics and Alumni Professor of the School of Nursing, Columbia University School of Nursing, New York, New York. Angelo B. Biviano, MD, MPH Associate Professor of Medicine, Columbia University Irving Medical Center, New York, New York. Hasan Garan, MD Dickinson W. Richards, Jr. Professor of Medicine, Columbia University Irving Medical Center, New York, New York. Isaac L. Goldenthal, MS Clinical Research Coordinator, Columbia University Irving Medical Center, New York, New York. Theresa A. Koleck, PhD, RN Associate Research Scientist, Columbia University School of Nursing, New York, New York. Ruth Masterson-Creber, PhD, MPH, RN, FAHA Assistant Professor of Healthcare Policy and Research, Weill Cornell Medical College, New York, New York. Meghan Reading Turchioe, PhD, MPH, RN Postdoctoral Researcher in Health Informatics, Weill Cornell Medical College, New York, New York. Haomiao Jia, PhD Professor of Biostatistics (in Nursing), Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Kathleen T', 'Initials': 'KT', 'LastName': 'Hickey', 'Affiliation': ''}, {'ForeName': 'Suzanne B', 'Initials': 'SB', 'LastName': 'Bakken', 'Affiliation': ''}, {'ForeName': 'Angelo B', 'Initials': 'AB', 'LastName': 'Biviano', 'Affiliation': ''}, {'ForeName': 'Hasan', 'Initials': 'H', 'LastName': 'Garan', 'Affiliation': ''}, {'ForeName': 'Isaac L', 'Initials': 'IL', 'LastName': 'Goldenthal', 'Affiliation': ''}, {'ForeName': 'Theresa A', 'Initials': 'TA', 'LastName': 'Koleck', 'Affiliation': ''}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Masterson-Creber', 'Affiliation': ''}, {'ForeName': 'Meghan Reading', 'Initials': 'MR', 'LastName': 'Turchioe', 'Affiliation': ''}, {'ForeName': 'Haomiao', 'Initials': 'H', 'LastName': 'Jia', 'Affiliation': ''}]",The Journal of cardiovascular nursing,['10.1097/JCN.0000000000000646']
3619,32015491,"Clinical significance of TP53, BIRC3, ATM and MAPK-ERK genes in chronic lymphocytic leukaemia: data from the randomised UK LRF CLL4 trial.","Despite advances in chronic lymphocytic leukaemia (CLL) treatment, globally chemotherapy remains a central treatment modality, with chemotherapy trials representing an invaluable resource to explore disease-related/genetic features contributing to long-term outcomes. In 499 LRF CLL4 cases, a trial with >12 years follow-up, we employed targeted resequencing of 22 genes, identifying 623 mutations. After background mutation rate correction, 11/22 genes were recurrently mutated at frequencies between 3.6% (NFKBIE) and 24% (SF3B1). Mutations beyond Sanger resolution (<12% VAF) were observed in all genes, with KRAS mutations principally composed of these low VAF variants. Firstly, employing orthogonal approaches to confirm <12% VAF TP53 mutations, we assessed the clinical impact of TP53 clonal architecture. Whilst ≥ 12% VAF TP53mut cases were associated with reduced PFS and OS, we could not demonstrate a difference between <12% VAF TP53 mutations and either wild type or ≥12% VAF TP53mut cases. Secondly, we identified biallelic BIRC3 lesions (mutation and deletion) as an independent marker of inferior PFS and OS. Finally, we observed that mutated MAPK-ERK genes were independent markers of poor OS in multivariate survival analysis. In conclusion, our study supports using targeted resequencing of expanded gene panels to elucidate the prognostic impact of gene mutations.",2020,"After background mutation rate correction, 11/22 genes were recurrently mutated at frequencies between 3.6% (NFKBIE) and 24% (SF3B1).","['chronic lymphocytic leukaemia (CLL', 'chronic lymphocytic leukaemia', '499 LRF CLL4 cases, a trial with >12 years follow-up, we employed targeted resequencing of 22 genes, identifying 623 mutations']",[],"['PFS and OS', 'Mutations beyond Sanger resolution', 'biallelic BIRC3 lesions (mutation and deletion']","[{'cui': 'C0023434', 'cui_str': 'Lymphoma, Small Lymphocytic'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}]",[],"[{'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C1442161', 'cui_str': 'Deletion (morphologic abnormality)'}]",,0.0594031,"After background mutation rate correction, 11/22 genes were recurrently mutated at frequencies between 3.6% (NFKBIE) and 24% (SF3B1).","[{'ForeName': 'Stuart J', 'Initials': 'SJ', 'LastName': 'Blakemore', 'Affiliation': 'Academic Unit of Cancer Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Clifford', 'Affiliation': 'Oxford National Institute for Health Research Biomedical Research Centre and Department of Oncology, University of Oxford, Oxford, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Parker', 'Affiliation': 'Academic Unit of Cancer Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Pavlos', 'Initials': 'P', 'LastName': 'Antoniou', 'Affiliation': 'Oxford National Institute for Health Research Biomedical Research Centre and Department of Oncology, University of Oxford, Oxford, UK.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Stec-Dziedzic', 'Affiliation': 'Oxford National Institute for Health Research Biomedical Research Centre and Department of Oncology, University of Oxford, Oxford, UK.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Larrayoz', 'Affiliation': 'Academic Unit of Cancer Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Zadie', 'Initials': 'Z', 'LastName': 'Davis', 'Affiliation': 'Department of Molecular Pathology, Royal Bournemouth Hospital, Bournemouth, UK.'}, {'ForeName': 'Latha', 'Initials': 'L', 'LastName': 'Kadalyayil', 'Affiliation': 'Genetic Epidemiology and Bioinformatics, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Colins', 'Affiliation': 'Genetic Epidemiology and Bioinformatics, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Robbe', 'Affiliation': 'Oxford National Institute for Health Research Biomedical Research Centre and Department of Oncology, University of Oxford, Oxford, UK.'}, {'ForeName': 'Dimitris', 'Initials': 'D', 'LastName': 'Vavoulis', 'Affiliation': 'Oxford National Institute for Health Research Biomedical Research Centre and Department of Oncology, University of Oxford, Oxford, UK.'}, {'ForeName': 'Jade', 'Initials': 'J', 'LastName': 'Forster', 'Affiliation': 'Academic Unit of Cancer Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Carr', 'Affiliation': 'Academic Unit of Cancer Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Morilla', 'Affiliation': 'Division of Molecular Pathology, The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Else', 'Affiliation': 'Division of Molecular Pathology, The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Bryant', 'Affiliation': 'Academic Unit of Cancer Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'McCarthy', 'Affiliation': 'Department of Molecular Pathology, Royal Bournemouth Hospital, Bournemouth, UK.'}, {'ForeName': 'Renata J', 'Initials': 'RJ', 'LastName': 'Walewska', 'Affiliation': 'Department of Molecular Pathology, Royal Bournemouth Hospital, Bournemouth, UK.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Steele', 'Affiliation': 'Academic Unit of Cancer Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Chan', 'Affiliation': 'Oxford Gene Technology, Begbroke Science Park, Begbroke, Oxfordshire, UK.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Speight', 'Affiliation': 'Oxford Gene Technology, Begbroke Science Park, Begbroke, Oxfordshire, UK.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Stankovic', 'Affiliation': 'Institute of Cancer and Genomic Sciences, College of Medical and Dental Services, IBR West, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Cragg', 'Affiliation': 'Academic Unit of Cancer Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Catovsky', 'Affiliation': 'Division of Molecular Pathology, The Institute of Cancer Research, London, UK.'}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Oscier', 'Affiliation': 'Department of Molecular Pathology, Royal Bournemouth Hospital, Bournemouth, UK.'}, {'ForeName': 'Matthew J J', 'Initials': 'MJJ', 'LastName': 'Rose-Zerilli', 'Affiliation': 'Academic Unit of Cancer Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Schuh', 'Affiliation': 'Oxford National Institute for Health Research Biomedical Research Centre and Department of Oncology, University of Oxford, Oxford, UK.'}, {'ForeName': 'Jonathan C', 'Initials': 'JC', 'LastName': 'Strefford', 'Affiliation': 'Academic Unit of Cancer Sciences, Faculty of Medicine, University of Southampton, Southampton, UK. jcs@soton.ac.uk.'}]",Leukemia,['10.1038/s41375-020-0723-2']
3620,32016250,Microbiota modulation and effects on metabolic biomarkers by orange juice: a controlled clinical trial.,"The impact of habitual orange juice consumption on microbiota, lipid and sugar metabolism was investigated in a controlled clinical trial. The clinical procedure is as follows: ten women who had a regular diet without orange juice for 30 days (OJ-free diet), followed by a regular diet plus 300 ml d-1 orange juice for 60 days (OJ-Diet), and 30 days with a regular diet without orange juice (Washout). Biochemical and dietary parameters were monitored, and blood, urine and stool samples were collected every 30 days until the end of the study. Hesperidin and naringin metabolites in the urine were identified by UHPLC, and the microbiota composition of the feces was determined by 16S rRNA. At the end of the OJ-Diet, there was a reduction in glucose (-6.5%), insulin (-33%), insulin resistance (-44%), LDL-C (-16%) and triglycerides (-30%). After the washout, these parameters returned to their initial values. There were no changes in the body weight or fat during the experimental time. The intestinal bacteria, Lactobacillus spp., Akkermansia spp., and Ruminococcus spp., increased after the intervention with orange juice. In addition, an inverse correlation was detected between these bacteria and glycemia, insulin, HOMA-IR, triglycerides, total cholesterol and LDL-C, but a direct correlation with HDL-C. In conclusion, orange juice showed a prebiotic effect, modulating the intestinal microbiota while improving the glycemia and lipid profiles.",2020,"In addition, an inverse correlation was detected between these bacteria and glycemia, insulin, HOMA-IR, triglycerides, total cholesterol and LDL-C, but a direct correlation with HDL-C.",['ten women who had a regular diet without orange juice for 30 days (OJ-free diet'],"['regular diet without orange juice (Washout', 'orange juice', 'habitual orange juice consumption']","['microbiota, lipid and sugar metabolism', 'reduction in glucose', 'body weight or fat', 'bacteria and glycemia, insulin, HOMA-IR, triglycerides, total cholesterol and LDL-C', 'Hesperidin and naringin metabolites', 'metabolic biomarkers', 'glycemia and lipid profiles', 'LDL-C', 'insulin resistance']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0184625', 'cui_str': 'Regular diet'}, {'cui': 'C0452458', 'cui_str': 'Orange juice'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}]","[{'cui': 'C0184625', 'cui_str': 'Regular diet'}, {'cui': 'C0452458', 'cui_str': 'Orange juice'}, {'cui': 'C0205353', 'cui_str': 'Habitual (qualifier value)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0242209', 'cui_str': 'Sugars'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1510439', 'cui_str': 'bacteria'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0019392', 'cui_str': 'Hesperidin'}, {'cui': 'C0068451', 'cui_str': 'naringin'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}]",,0.028913,"In addition, an inverse correlation was detected between these bacteria and glycemia, insulin, HOMA-IR, triglycerides, total cholesterol and LDL-C, but a direct correlation with HDL-C.","[{'ForeName': 'Melaine', 'Initials': 'M', 'LastName': 'Fidélix', 'Affiliation': 'Laboratory of Nutrition, School of Pharmaceutical Science, São Paulo State University - UNESP, Araraquara, SP, Brazil. thais.cesar@unesp.br.'}, {'ForeName': 'Dragan', 'Initials': 'D', 'LastName': 'Milenkovic', 'Affiliation': 'Department of Internal Medicine, UC Davis School of Medicine, University of California, Davis, USA and Université Clermont Auvergne, INRA, UNH, CRNH Auvergne, F-63000 Clermont-Ferrand, France.'}, {'ForeName': 'Katia', 'Initials': 'K', 'LastName': 'Sivieri', 'Affiliation': 'Laboratory of Nutrition, School of Pharmaceutical Science, São Paulo State University - UNESP, Araraquara, SP, Brazil. thais.cesar@unesp.br.'}, {'ForeName': 'Thais', 'Initials': 'T', 'LastName': 'Cesar', 'Affiliation': 'Laboratory of Nutrition, School of Pharmaceutical Science, São Paulo State University - UNESP, Araraquara, SP, Brazil. thais.cesar@unesp.br.'}]",Food & function,['10.1039/c9fo02623a']
3621,32012398,A randomized controlled trial of a nurse-led education pathway for asthmatic children from outpatient to home.,"BACKGROUND


Education for asthmatic children in the outpatient department is insufficient.
AIM


To evaluate the efficacy of a nurse-led education pathway, a standard education programme, on children with asthma.
METHODS


One hundred and eighty participants enrolled and were randomly assigned to either the control group or the intervention group. The intervention group received predetermined step-by-step education sessions based on the self-designed education pathway, while the control group received usual care. Asthma control, health-related quality of life, and health-care utilization measures were taken at baseline and at follow-up visits between February 2016 and May 2018.
RESULTS


Significantly higher scores for health-related quality of life and inhaler technique at the third-month visit and asthma control test at the sixth-month visit were seen in the intervention group. The numbers of unscheduled physician visits and school absences were lower in the intervention group than in the control group within 6 months. However, no significant differences were observed in emergency department visits and hospitalizations.
CONCLUSION


The nurse-led education pathway could be considered effective for children with asthma visiting the outpatient department.",2020,The numbers of unscheduled physician visits and school absences were lower in the intervention group than in the control group within 6 months.,"['children with asthma', 'asthmatic children from outpatient to home', 'children with asthma visiting the outpatient department', 'One hundred and eighty participants enrolled', 'asthmatic children']","['predetermined step-by-step education sessions based on the self-designed education pathway, while the control group received usual care', 'nurse-led education pathway', 'nurse-led education pathway, a standard education programme']","['emergency department visits and hospitalizations', 'health-related quality of life and inhaler technique', 'Asthma control, health-related quality of life, and health-care utilization measures', 'numbers of unscheduled physician visits and school absences']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C4319557', 'cui_str': '180'}]","[{'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0729314', 'cui_str': 'Education provision (procedure)'}]","[{'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0021461', 'cui_str': 'Inhalators'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0030672', 'cui_str': 'Patient Acceptance of Healthcare'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C1689985', 'cui_str': 'Absence'}]",180.0,0.0303662,The numbers of unscheduled physician visits and school absences were lower in the intervention group than in the control group within 6 months.,"[{'ForeName': 'Guozhen', 'Initials': 'G', 'LastName': 'Gao', 'Affiliation': 'Department of Nursing, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Yaoji', 'Initials': 'Y', 'LastName': 'Liao', 'Affiliation': 'School of Nursing, Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Lulu', 'Initials': 'L', 'LastName': 'Mo', 'Affiliation': 'Department of Urology, The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Yucui', 'Initials': 'Y', 'LastName': 'Gong', 'Affiliation': 'Department of Nursing, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Shao', 'Affiliation': 'Department of Nursing, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Jinying', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Nursing, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}]",International journal of nursing practice,['10.1111/ijn.12823']
3622,31935529,Cognitive behavior therapy in early psychosis with a focus on depression and low self-esteem: A randomized controlled trial.,"BACKGROUND


Patients in early phases of psychosis often struggle with depressive symptoms and low self-esteem. The main aims of the present study were to examine whether cognitive behavior therapy (CBT) compared to treatment as usual (TAU) would reduce depressive symptoms (primary outcome) and increase self-esteem (secondary outcome). Furthermore, we wanted to examine whether CBT reduces symptoms measured with the PANSS (positive, negative, cognitive, or excited symptoms) or increases general functioning compared to TAU.
METHODS


A total of 63 early psychosis patients were included and randomly assigned to receive either CBT (maximum 26 sessions) or TAU for a period of up to six months. A linear mixed model was used for longitudinal analysis, with a focus on whether patients in the CBT group or the TAU group changed differently to one another between the baseline and 15-month follow-up.
RESULTS


There were no differences between the CBT group and TAU group regarding improvements in depressive symptoms measured with the Calgary Depression Scale for Schizophrenia (P = 0.188) or self-esteem measured with the Rosenberg Self-Esteem Scale (P = 0.580). However, patients in the CBT group improved significantly more on negative symptoms (P = 0.002) and social functioning (P = 0.001).
CONCLUSIONS


We did not find CBT to be more effective than TAU in reducing depressive symptoms or increasing self-esteem in patients with early psychosis. However, CBT seems to improve negative symptoms and functioning. These results still need to be replicated in further studies as the present one was merely an exploratory analysis. ClinicalTrials.gov Identifier: NCT01511406.",2020,There were no differences between the CBT group and TAU group regarding improvements in depressive symptoms measured with the Calgary Depression Scale for Schizophrenia (P = 0.188) or self-esteem measured with the Rosenberg Self-Esteem Scale (P = 0.580).,"['63 early psychosis patients', 'Patients in early phases of psychosis often struggle with depressive symptoms and low self-esteem', 'patients with early psychosis', 'early psychosis with a focus on depression and low self-esteem']","['TAU', 'cognitive behavior therapy (CBT', 'CBT', 'Cognitive behavior therapy', 'CBT (maximum 26 sessions) or TAU']","['Calgary Depression Scale for Schizophrenia', 'social functioning', 'depressive symptoms', 'Rosenberg Self-Esteem Scale', 'self-esteem', 'negative symptoms']","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0033975', 'cui_str': 'Psychoses'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0679136', 'cui_str': 'Low self-esteem (finding)'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]","[{'cui': 'C1720655', 'cui_str': 'Tau'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0582666', 'cui_str': 'Rosenberg self-esteem scale (assessment scale)'}, {'cui': 'C0036597', 'cui_str': 'Self Esteem'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",63.0,0.163251,There were no differences between the CBT group and TAU group regarding improvements in depressive symptoms measured with the Calgary Depression Scale for Schizophrenia (P = 0.188) or self-esteem measured with the Rosenberg Self-Esteem Scale (P = 0.580).,"[{'ForeName': 'Nasrettin', 'Initials': 'N', 'LastName': 'Sönmez', 'Affiliation': 'Diakonhjemmet Hospital, Forskningsveien 7, 0373 Oslo, Norway; Department of Research and Education, Clinic of Mental Health and Addiction, Oslo University Hospital, Norway.'}, {'ForeName': 'Kristin Lie', 'Initials': 'KL', 'LastName': 'Romm', 'Affiliation': 'Department of Research and Education, Clinic of Mental Health and Addiction, Oslo University Hospital, Norway; NORMENT, KG Jebsen Centre for Psychosis Research, Institute of Clinical Medicine, University of Oslo, 0424 Oslo, Norway.'}, {'ForeName': 'Tiril', 'Initials': 'T', 'LastName': 'Østefjells', 'Affiliation': 'NORMENT, KG Jebsen Centre for Psychosis Research, Institute of Clinical Medicine, University of Oslo, 0424 Oslo, Norway; Department for Specialised Inpatient Treatment, Akershus University Hospital, Sykehusveien 25, 1478 Lørenskog, Norway.'}, {'ForeName': 'Marit', 'Initials': 'M', 'LastName': 'Grande', 'Affiliation': 'Grande, Sandviksveien 157, 1337 Sandvika, Norway.'}, {'ForeName': 'Lene Hunnicke', 'Initials': 'LH', 'LastName': 'Jensen', 'Affiliation': 'Early Intervention in Psychosis Unit, Vestre Viken Hospital Trust, Drammen, Norway.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Hummelen', 'Affiliation': 'Department of Research and Education, Clinic of Mental Health and Addiction, Oslo University Hospital, Norway.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Tesli', 'Affiliation': 'NORMENT, KG Jebsen Centre for Psychosis Research, Institute of Clinical Medicine, University of Oslo, 0424 Oslo, Norway; Department of Mental Disorders, Norwegian Institute of Public Health, P.O. Box 4404, Nydalen, 0403 Oslo, Norway.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Melle', 'Affiliation': 'Department of Research and Education, Clinic of Mental Health and Addiction, Oslo University Hospital, Norway; NORMENT, KG Jebsen Centre for Psychosis Research, Institute of Clinical Medicine, University of Oslo, 0424 Oslo, Norway.'}, {'ForeName': 'Jan Ivar', 'Initials': 'JI', 'LastName': 'Røssberg', 'Affiliation': 'Department of Research and Education, Clinic of Mental Health and Addiction, Oslo University Hospital, Norway; NORMENT, KG Jebsen Centre for Psychosis Research, Institute of Clinical Medicine, University of Oslo, 0424 Oslo, Norway. Electronic address: j.i.rossberg@medisin.uio.no.'}]",Comprehensive psychiatry,['10.1016/j.comppsych.2019.152157']
3623,30251616,Individual placement and support for vocational recovery in first-episode psychosis: randomised controlled trial.,"BACKGROUND


High unemployment is a hallmark of psychotic illness. Individual placement and support (IPS) may be effective at assisting the vocational recoveries of young people with first-episode psychosis (FEP).AimsTo examine the effectiveness of IPS at assisting young people with FEP to gain employment (Australian and Clinical Trials Registry ACTRN12608000094370).
METHOD


Young people with FEP (n = 146) who were interested in vocational recovery were randomised using computer-generated random permuted blocks on a 1:1 ratio to: (a) 6 months of IPS in addition to treatment as usual (TAU) or (b) TAU alone. Assessments were conducted at baseline, 6 months (end of intervention), 12 months and 18 months post-baseline by research assistants who were masked to the treatment allocations.
RESULTS


At the end of the intervention the IPS group had a significantly higher rate of having been employed (71.2%) than the TAU group (48.0%), odds ratio 3.40 (95% CI 1.17-9.91, z = 2.25, P = 0.025). However, this difference was not seen at 12- and 18-month follow-up points. There was no difference at any time point on educational outcomes.
CONCLUSIONS


This is the largest trial to our knowledge on the effectiveness of IPS in FEP. The IPS group achieved a very high employment rate during the 6 months of the intervention. However, the advantage of IPS was not maintained in the long term. This seems to be related more to an unusually high rate of employment being achieved in the control group rather than a gross reduction in employment among the IPS group.Declaration of interestNone.",2019,"At the end of the intervention the IPS group had a significantly higher rate of having been employed (71.2%) than the TAU group (48.0%), odds ratio 3.40 (95% CI 1.17-9.91, z = 2.25, P = 0.025).",['Young people with FEP (n = 146) who were interested in vocational recovery'],"['Individual placement and support', 'Individual placement and support (IPS', 'IPS in addition to treatment as usual (TAU) or (b) TAU alone']","['employment rate', 'educational outcomes']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0032611', 'cui_str': 'Polytetrafluoroethylene'}, {'cui': 'C0543488', 'cui_str': 'Interested (finding)'}]","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1720655', 'cui_str': 'Tau'}]","[{'cui': 'C0014003', 'cui_str': 'Employment'}]",146.0,0.111386,"At the end of the intervention the IPS group had a significantly higher rate of having been employed (71.2%) than the TAU group (48.0%), odds ratio 3.40 (95% CI 1.17-9.91, z = 2.25, P = 0.025).","[{'ForeName': 'Eóin', 'Initials': 'E', 'LastName': 'Killackey', 'Affiliation': 'Professor of Functional Recovery in Youth Mental Health, Orygen,The National Centre of Excellence in Youth Mental Health and Centre for Youth Mental Health,The University of Melbourne,Australia.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Allott', 'Affiliation': 'Senior Research Fellow, Orygen,The National Centre of Excellence in Youth Mental Health and Centre for Youth Mental Health,The University of Melbourne,Australia.'}, {'ForeName': 'Henry J', 'Initials': 'HJ', 'LastName': 'Jackson', 'Affiliation': 'Professor, Melbourne School of Psychological Sciences,The University of Melbourne,Australia.'}, {'ForeName': 'Rosanna', 'Initials': 'R', 'LastName': 'Scutella', 'Affiliation': 'Senior Research Fellow, Melbourne Institute,The University of Melbourne,Australia.'}, {'ForeName': 'Yi-Ping', 'Initials': 'YP', 'LastName': 'Tseng', 'Affiliation': 'Senior Research Fellow, Melbourne Institute,The University of Melbourne,Australia.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Borland', 'Affiliation': 'Professor, Melbourne Institute and Department of Economics,The University of Melbourne,Australia.'}, {'ForeName': 'Tina-Marie', 'Initials': 'TM', 'LastName': 'Proffitt', 'Affiliation': 'Research Fellow and Neuropsychologist, Orygen,The National Centre of Excellence in Youth Mental Health,Centre for Youth Mental Health,The University of Melbourne andSchool of Psychology,University of Waikato,Australia.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Hunt', 'Affiliation': 'Research Fellow, School of Medicine and Public Health,University of Newcastle,Australia.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Kay-Lambkin', 'Affiliation': 'Associate Professor, School of Medicine and Public Health,University of Newcastle,Australia.'}, {'ForeName': 'Gina', 'Initials': 'G', 'LastName': 'Chinnery', 'Affiliation': 'National Vocational Services Manager, Orygen,The National Centre of Excellence in Youth Mental Health, Australia.'}, {'ForeName': 'Gennady', 'Initials': 'G', 'LastName': 'Baksheev', 'Affiliation': 'Research Assistant, Monash University,Australia.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Alvarez-Jimenez', 'Affiliation': 'Associate Professor, Orygen,The National Centre of Excellence in Youth Mental Health and Centre for Youth Mental Health,The University of Melbourne,Australia.'}, {'ForeName': 'Patrick D', 'Initials': 'PD', 'LastName': 'McGorry', 'Affiliation': 'Professor, Orygen,The National Centre of Excellence in Youth Mental Health andCentre for Youth Mental Health,The University of Melbourne, Australia.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Cotton', 'Affiliation': 'Professor, Orygen,The National Centre of Excellence in Youth Mental Health and Centre for Youth Mental Health,The University of Melbourne,Australia.'}]",The British journal of psychiatry : the journal of mental science,['10.1192/bjp.2018.191']
3624,31992327,Biologically effective dose (BED) escalation of stereotactic body radiotherapy (SBRT) for hepatocellular carcinoma patients (≤5 cm) with CyberKnife: protocol of study.,"BACKGROUND


There is a lack of data on the biologically effective dose and the efficacy of stereotactic body radiotherapy in hepatocellular carcinoma patients, and this study was conducted to explore the relation between BED and efficacy.
METHODS


This study is designed as a mono-center study. The participants are randomized into three group, and received the following recommended schedule: 49Gy/7f, 54Gy/6f and 55Gy/5f with BED 10  in correspondence to 83.3Gy, 102.6Gy and 115.5Gy. The primary outcome measures are to calculate local control rates (LC), overall survival rates (OS) and progression-free survival rates (PFS). The secondary outcome measures are to observe radiation-induced liver injury (RILD) rates, Child-Pugh score and indocyanine green retention rate at 15 min (ICG-R15) value before and after CK-SBRT. Moreover, gastrointestinal toxicities are also observed.
DISCUSSION


There is no uniform standard for CK-SBRT dose schedule of hepatocellular carcinoma. We propose to conduct a study determining the optimal CK-SBRT schedule of hepatocellular carcinoma patients (≤5 cm). The trial protocol has been approved by the Institutional Review Board of 302 Hospital of PLA (People's Liberation Army). The Ethics number is 2017111D.
TRAIL REGISTRATION


Clinical trails number: NCT03295500. Date of registration: November, 2017.",2020,Pugh score and indocyanine green retention rate at 15 min (ICG-R15) value before and after CK-SBRT.,"['hepatocellular carcinoma patients (≤5\u2009cm) with CyberKnife', 'hepatocellular carcinoma patients', ""302 Hospital of PLA (People's Liberation Army"", 'hepatocellular carcinoma patients (≤5\u2009cm']","['stereotactic body radiotherapy', 'stereotactic body radiotherapy (SBRT']","['observe radiation-induced liver injury (RILD) rates, Child', 'Pugh score and indocyanine green retention rate', 'gastrointestinal toxicities', 'calculate local control rates (LC), overall survival rates (OS) and progression-free survival rates (PFS']","[{'cui': 'C2239176', 'cui_str': 'Liver Cell Carcinoma, Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1300683', 'cui_str': 'CyberKnife'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C1720823', 'cui_str': 'Stereotactic Body Radiotherapy'}]","[{'cui': 'C3875135', 'cui_str': 'Observes (attribute)'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0160390', 'cui_str': 'Injury of liver (disorder)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0021234', 'cui_str': 'Indocyanine Green'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C1142499', 'cui_str': 'Gastrointestinal toxicity'}, {'cui': 'C0444686', 'cui_str': 'Calculated (qualifier value)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",,0.139361,Pugh score and indocyanine green retention rate at 15 min (ICG-R15) value before and after CK-SBRT.,"[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Radiation Oncology Center, The Fifth Medical Center of PLA General Hospital (Beijing 302 Hospital), No. 100 Xi Si Huan Middle Road, Fengtai District, Beijing, 100039, China.'}, {'ForeName': 'Aimin', 'Initials': 'A', 'LastName': 'Zhang', 'Affiliation': 'Radiation Oncology Center, The Fifth Medical Center of PLA General Hospital (Beijing 302 Hospital), No. 100 Xi Si Huan Middle Road, Fengtai District, Beijing, 100039, China.'}, {'ForeName': 'Wengang', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Radiation Oncology Center, The Fifth Medical Center of PLA General Hospital (Beijing 302 Hospital), No. 100 Xi Si Huan Middle Road, Fengtai District, Beijing, 100039, China.'}, {'ForeName': 'Quan', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Radiation Oncology Center, The Fifth Medical Center of PLA General Hospital (Beijing 302 Hospital), No. 100 Xi Si Huan Middle Road, Fengtai District, Beijing, 100039, China.'}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': 'Radiation Oncology Center, The Fifth Medical Center of PLA General Hospital (Beijing 302 Hospital), No. 100 Xi Si Huan Middle Road, Fengtai District, Beijing, 100039, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'Radiation Oncology Center, The Fifth Medical Center of PLA General Hospital (Beijing 302 Hospital), No. 100 Xi Si Huan Middle Road, Fengtai District, Beijing, 100039, China.'}, {'ForeName': 'Xuezhang', 'Initials': 'X', 'LastName': 'Duan', 'Affiliation': 'Radiation Oncology Center, The Fifth Medical Center of PLA General Hospital (Beijing 302 Hospital), No. 100 Xi Si Huan Middle Road, Fengtai District, Beijing, 100039, China. duanxuezhang2006@163.com.'}]","Radiation oncology (London, England)",['10.1186/s13014-020-1471-1']
3625,31891746,Higher dose of resveratrol elevated cardiovascular disease risk biomarker levels in overweight older adults - A pilot study.,"Older adults are at high risk of developing cardiovascular disease (CVD). Pre-clinical studies indicate that resveratrol (RSV), a polyphenol commonly found in grapes and red wine, may help prevent development of CVD. Based on our previous reports where the 300 mg and 1000 mg doses appeared safe and improved psychomotor function in a dose-dependent manner, our hypothesis was that RSV would reduce biomarkers of CVD risk in overweight, but otherwise healthy older adults and that 1000 mg would lower CVD biomarkers >300 mg. This analysis was performed on samples from older participants (65 years and older) who were randomized to a 90 day RSV treatment with 300 mg (n = 10), 1000 mg (n = 9) or placebo (n = 10). We measured levels of CVD risk biomarkers i.e. oxidized low-density lipoprotein (oxLDL), soluble E-selectin-1 (sE-selectin), soluble Intercellular Adhesion Molecule-1 (sICAM-1), Soluble Vascular Cell Adhesion Molecule-1 (sVCAM-1), total plasminogen activator inhibitor (tPAI-1). Statistical significance was set at p < 0.05. Both sVCAM-1 and tPAI increased significantly more in the 1000 mg vs. 300 mg and placebo groups. Other biomarkers (300 mg vs. 1000 mg vs. placebo: oxLDL, sEselectin-1 and sICAM-1) followed the same trend toward higher levels in the 1000 mg group compared to the 300 mg and placebo groups, without reaching statistical significance. This pilot project suggests that a higher dose of RSV may increase the levels of CVD risk biomarkers in overweight older adults. Given no change in the CVD risk biomarkers in response to a lower dose, future studies should test the effects of different doses of RSV to evaluate potential detrimental effects of higher doses on CVD biomarkers and measures of cardiovascular function in older adults at risk for CVD.",2020,Both sVCAM-1 and tPAI increased significantly more in the 1000 mg vs. 300 mg and placebo groups.,"['overweight older adults', 'Older adults', 'older adults at risk for CVD', 'older participants (65\u202fyears and older']","['placebo', 'RSV', 'resveratrol (RSV']","['sVCAM-1 and tPAI', 'cardiovascular function', 'levels of CVD risk biomarkers i.e. oxidized low-density lipoprotein (oxLDL), soluble E-selectin-1 (sE-selectin), soluble Intercellular Adhesion Molecule-1 (sICAM-1), Soluble Vascular Cell Adhesion Molecule-1 (sVCAM-1), total plasminogen activator inhibitor (tPAI-1', 'safe and improved psychomotor function', 'CVD risk biomarkers']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0035236', 'cui_str': 'Respiratory syncytial virus'}, {'cui': 'C2930481', 'cui_str': 'cis-Resveratrol'}]","[{'cui': 'C0007227', 'cui_str': 'Cardiovascular Physiology'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0348035', 'cui_str': 'oxidized low density lipoprotein'}, {'cui': 'C0115305', 'cui_str': 'LECAM-2'}, {'cui': 'C0282651', 'cui_str': 'Selectins'}, {'cui': 'C0063695', 'cui_str': 'CD54 Antigens'}, {'cui': 'C0078056', 'cui_str': 'CD106 Antigens'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0032145', 'cui_str': 'Plasminogen Activator Inhibitors'}, {'cui': 'C0031843', 'cui_str': 'function'}]",1000.0,0.17455,Both sVCAM-1 and tPAI increased significantly more in the 1000 mg vs. 300 mg and placebo groups.,"[{'ForeName': 'R T', 'Initials': 'RT', 'LastName': 'Mankowski', 'Affiliation': 'Department of Aging and Geriatric Research, University of Florida, Gainesville, FL, USA. Electronic address: r.mankowski@ufl.edu.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'You', 'Affiliation': 'Department of Biostatistics, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'T W', 'Initials': 'TW', 'LastName': 'Buford', 'Affiliation': 'Department of Medicine, UAB School of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Leeuwenburgh', 'Affiliation': 'Department of Aging and Geriatric Research, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'T M', 'Initials': 'TM', 'LastName': 'Manini', 'Affiliation': 'Department of Aging and Geriatric Research, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Schneider', 'Affiliation': 'Department of Aging and Geriatric Research, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Qiu', 'Affiliation': 'Department of Biostatistics, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'S D', 'Initials': 'SD', 'LastName': 'Anton', 'Affiliation': 'Department of Aging and Geriatric Research, University of Florida, Gainesville, FL, USA.'}]",Experimental gerontology,['10.1016/j.exger.2019.110821']
3626,31848551,Is soy protein effective in reducing cholesterol and improving bone health?,"Hyperlipidemia associated with cardiovascular health, and bone loss with regard to osteoporosis contribute to increased morbidity and mortality and are influenced by diet. Soy protein has been shown to reduce cholesterol levels, and its isoflavones may improve bone health. The objective of this study was to determine the effects of soy protein on lipid profiles and biomarkers of bone metabolism and inflammation. Ninety men and women (aged 27-87) were randomly assigned to consume 40 g of soy or casein protein daily for three months. Both soy and casein consumption significantly reduced bone alkaline phosphatase (P = 0.011) and body fat % (P < 0.001), tended to decrease tartrate-resistant acid phosphatase (P = 0.066), and significantly increased serum insulin-like growth factor-I (IGF-1) (P < 0.001), yet soy increased IGF-1 to a greater extent (P = 0.01) than casein. Neither treatment affected total cholesterol, HDL cholesterol, LDL cholesterol, or C-reactive protein. These results demonstrate that daily supplementation of soy and casein protein may have positive effects on indices of bone metabolism and body composition, with soy protein being more effective at increasing IGF-1, an anabolic factor, which may be due to soy isoflavones' role in upregulating Runx2 gene expression, while having little effect on lipid profiles and markers of inflammation.",2020,"Both soy and casein consumption significantly reduced bone alkaline phosphatase (P = 0.011) and body fat % (P < 0.001), tended to decrease tartrate-resistant acid phosphatase (P = 0.066), and significantly increased serum insulin-like growth factor-I (IGF-1) (P < 0.001), yet soy increased IGF-1 to a greater extent (P = 0.01) than casein.",['Ninety men and women (aged 27-87'],"['soy and casein protein', 'consume 40 g of soy or casein protein', 'soy protein', 'soy and casein consumption', 'Soy protein']","['serum insulin-like growth factor-I (IGF-1', 'bone alkaline phosphatase', 'lipid profiles and biomarkers of bone metabolism and inflammation', 'total cholesterol, HDL cholesterol, LDL cholesterol, or C-reactive protein', 'cholesterol and improving bone health', 'tartrate-resistant acid phosphatase', 'cholesterol levels']","[{'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0007332', 'cui_str': 'Caseins'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0074926', 'cui_str': 'Soy Proteins'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0018284', 'cui_str': 'Growth factor (substance)'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C1868883', 'cui_str': 'Bone alkaline phosphatase'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol, HDL2'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C2106410', 'cui_str': 'Tartrate-resistant acid phosphatase'}, {'cui': 'C0428466', 'cui_str': 'Finding of cholesterol level (finding)'}]",90.0,0.0403632,"Both soy and casein consumption significantly reduced bone alkaline phosphatase (P = 0.011) and body fat % (P < 0.001), tended to decrease tartrate-resistant acid phosphatase (P = 0.066), and significantly increased serum insulin-like growth factor-I (IGF-1) (P < 0.001), yet soy increased IGF-1 to a greater extent (P = 0.01) than casein.","[{'ForeName': 'Kelli S', 'Initials': 'KS', 'LastName': 'George', 'Affiliation': 'Department of Nutrition, Food and Exercise Sciences, Florida State University, Tallahassee, FL, USA. barjmandi@fsu.edu.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Muñoz', 'Affiliation': ''}, {'ForeName': 'Neda S', 'Initials': 'NS', 'LastName': 'Akhavan', 'Affiliation': ''}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Foley', 'Affiliation': ''}, {'ForeName': 'Shalom C', 'Initials': 'SC', 'LastName': 'Siebert', 'Affiliation': ''}, {'ForeName': 'Gershon', 'Initials': 'G', 'LastName': 'Tenenbaum', 'Affiliation': ''}, {'ForeName': 'Dania A', 'Initials': 'DA', 'LastName': 'Khalil', 'Affiliation': ''}, {'ForeName': 'Sheau C', 'Initials': 'SC', 'LastName': 'Chai', 'Affiliation': ''}, {'ForeName': 'Bahram H', 'Initials': 'BH', 'LastName': 'Arjmandi', 'Affiliation': ''}]",Food & function,['10.1039/c9fo01081e']
3627,31859318,Effect of semolina pudding prepared from starch branching enzyme IIa and b mutant wheat on glycaemic response in vitro and in vivo: a randomised controlled pilot study.,"Refined starchy foods are usually rapidly digested, leading to poor glycaemic control, but not all starchy foods are the same. Complex carbohydrates like resistant starch (RS) have been shown to reduce the metabolic risk factors for chronic diseases such as hyperglycaemia and overweight. The aim of the project was to develop a semolina-based food made from a starch branching enzyme II (sbeIIa/b-AB) durum wheat mutant with a high RS content and to measure its glycaemic index using a double-blind randomised pilot study. We report here the amylose, RS and non-starch polysaccharide concentration of raw sbeIIa/b-AB and wild-type control (WT) semolina. We measured RS after cooking to identify a model food for in vivo testing. Retrograded sbeIIa/b-AB semolina showed a higher RS concentration than the WT control (RS = 4.87 ± 0.6 g per 100 g, 0.77 ± 0.34 g per 100 g starch DWB, respectively), so pudding was selected as the test food. Ten healthy participants consumed ∼50 g of total starch from WT and sbeIIa/b-AB pudding and a standard glucose drink. Capillary blood glucose concentrations were measured in the fasting and postprandial state (2 h): incremental area-under-the-curve (iAUC) and GI were calculated. We found no evidence of difference in GI between sbeIIa/b-AB pudding and the WT control, but the starch digestibility was significantly lower in sbeIIa/b-AB pudding compared to the WT control in vitro (C90 = 33.29% and 47.38%, respectively). Based on these results, novel sbeIIa/b-AB wheat foods will be used in future in vivo studies to test the effect of different RS concentrations and different food matrices on glycaemia.",2020,"We found no evidence of difference in GI between sbeIIa/b-AB pudding and the WT control, but the starch digestibility was significantly lower in sbeIIa/b-AB pudding compared to the WT control in vitro (C90 = 33.29% and 47.38%, respectively).","['vitro and in vivo', 'Ten healthy participants']","['semolina pudding prepared from starch branching enzyme IIa and b mutant wheat', 'consumed ∼50 g of total starch from WT and sbeIIa/b-AB pudding and a standard glucose drink', 'Complex carbohydrates like resistant starch (RS']","['Capillary blood glucose concentrations', 'glycaemic response', 'fasting and postprandial state (2 h): incremental area-under-the-curve (iAUC) and GI', 'starch digestibility']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0452687', 'cui_str': 'Semolina (substance)'}, {'cui': 'C4082130', 'cui_str': 'Prepared (qualifier value)'}, {'cui': 'C0038179', 'cui_str': 'Starch'}, {'cui': 'C3541394', 'cui_str': 'Enzymes'}, {'cui': 'C0043137', 'cui_str': 'Wheat'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0556154', 'cui_str': 'Complex carbohydrate (substance)'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}]","[{'cui': 'C0229666', 'cui_str': 'Capillary blood (substance)'}, {'cui': 'C1287281', 'cui_str': 'Finding of glucose concentration, dipstick (finding)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0038179', 'cui_str': 'Starch'}]",10.0,0.0402673,"We found no evidence of difference in GI between sbeIIa/b-AB pudding and the WT control, but the starch digestibility was significantly lower in sbeIIa/b-AB pudding compared to the WT control in vitro (C90 = 33.29% and 47.38%, respectively).","[{'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Corrado', 'Affiliation': 'Food Innovation and Health, Quadram Institute Bioscience, Norwich Research Park, UK. brittany.hazard@quadram.ac.uk.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Cherta-Murillo', 'Affiliation': ''}, {'ForeName': 'Edward S', 'Initials': 'ES', 'LastName': 'Chambers', 'Affiliation': ''}, {'ForeName': 'Abigail J', 'Initials': 'AJ', 'LastName': 'Wood', 'Affiliation': ''}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Plummer', 'Affiliation': ''}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Lovegrove', 'Affiliation': ''}, {'ForeName': 'Cathrina H', 'Initials': 'CH', 'LastName': 'Edwards', 'Affiliation': ''}, {'ForeName': 'Gary S', 'Initials': 'GS', 'LastName': 'Frost', 'Affiliation': ''}, {'ForeName': 'Brittany A', 'Initials': 'BA', 'LastName': 'Hazard', 'Affiliation': ''}]",Food & function,['10.1039/c9fo02460c']
3628,32002617,A randomized trial comparing vascular access strategies for patients receiving chemotherapy with trastuzumab for early-stage breast cancer.,"PURPOSE


Trastuzumab-based chemotherapy is usually administered through either a peripherally inserted central catheter (PICC) or a totally implanted vascular access device (PORT). As the most effective type of access is unknown, a feasibility trial, prior to conducting a large pragmatic trial, was undertaken.
METHODS


The trial methodology utilized the integrated consent model incorporating oral consent. Patients receiving trastuzumab-based neo/adjuvant chemotherapy for early-stage breast cancer were randomized to a PICC or PORT insertion. Feasibility was reflected through a combination of endpoints; however, the a priori definition of feasibility was > 25% of patients approached agreed to randomization and > 25% of physicians approached patients. Secondary outcomes included rates of line-associated complications such as thrombotic events requiring anticoagulation, line infections or phlebitis.
RESULTS


During the study period, 4/15 (26.7%) medical oncologists approached patients about study participation. Of 59 patients approached, 56 (94.9%) agreed to randomization, 29 (51.8%) were randomized to PICC and 27 (48.2%) to PORT access. Overall, 17.2% (5/29) and 14.8% (4/27) of patients had at least one line-associated complication in the PICC and PORT arms respectively. The study was terminated early due to slow accrual.
CONCLUSION


The study met its feasibility endpoints with respect to patient and physician engagement. However, the slow rate of accrual (56 patients in 2 years) means that conducting a large pragmatic trial would require additional strategies to make such a study possible.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT02632435.",2020,"Secondary outcomes included rates of line-associated complications such as thrombotic events requiring anticoagulation, line infections or phlebitis.
","['patients receiving chemotherapy with trastuzumab for early-stage breast cancer', 'for early-stage breast cancer', 'Of 59 patients approached, 56 (94.9%) agreed to randomization, 29 (51.8']","['PICC or PORT insertion', 'trastuzumab-based neo/adjuvant chemotherapy', 'Trastuzumab-based chemotherapy']","['rates of line-associated complications such as thrombotic events requiring anticoagulation, line infections or phlebitis']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C0452253', 'cui_str': 'Port (substance)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0031542', 'cui_str': 'Phlebitis'}]",59.0,0.180013,"Secondary outcomes included rates of line-associated complications such as thrombotic events requiring anticoagulation, line infections or phlebitis.
","[{'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Clemons', 'Affiliation': 'Department of Medicine, Division of Medical Oncology, The Ottawa Hospital and University of Ottawa, Ottawa, Canada. mclemons@toh.ca.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Stober', 'Affiliation': 'Cancer Therapeutics Program, Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Kehoe', 'Affiliation': 'Department of Medicine, Division of Medical Oncology, The Ottawa Hospital and University of Ottawa, Ottawa, Canada.'}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Bedard', 'Affiliation': 'Department of Nursing, Ottawa General Hospital, Ottawa, Canada.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'MacDonald', 'Affiliation': 'Department of Nursing, Ottawa General Hospital, Ottawa, Canada.'}, {'ForeName': 'Marie-Claude', 'Initials': 'MC', 'LastName': 'Brunet', 'Affiliation': 'Department of Nursing, Ottawa General Hospital, Ottawa, Canada.'}, {'ForeName': 'Deanna', 'Initials': 'D', 'LastName': 'Saunders', 'Affiliation': 'Cancer Therapeutics Program, Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Vandermeer', 'Affiliation': 'Cancer Therapeutics Program, Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'Sasha', 'Initials': 'S', 'LastName': 'Mazzarello', 'Affiliation': 'Cancer Therapeutics Program, Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'Arif', 'Initials': 'A', 'LastName': 'Awan', 'Affiliation': 'Department of Medicine, Division of Medical Oncology, The Ottawa Hospital and University of Ottawa, Ottawa, Canada.'}, {'ForeName': 'Bassam', 'Initials': 'B', 'LastName': 'Basulaiman', 'Affiliation': 'Department of Medicine, Division of Medical Oncology, The Ottawa Hospital and University of Ottawa, Ottawa, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Robinson', 'Affiliation': 'Division of Medical Oncology, Cancer Centre of Southeastern Ontario, Kingston, Canada.'}, {'ForeName': 'Ranjeeta', 'Initials': 'R', 'LastName': 'Mallick', 'Affiliation': 'Department of Medicine, University of Ottawa, Ottawa, Canada.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Hutton', 'Affiliation': 'Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Fergusson', 'Affiliation': 'Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Canada.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-020-05326-y']
3629,31345051,Feasibility and potential effects of interdisciplinary home-based reablement program (I-HARP) for people with cognitive and functional decline: a pilot trial.,"Objectives:  To test feasibility and potential effects of the interdisciplinary Home-bAsed Reablement Program (I-HARP) that integrates evidence-based strategies and cognitive rehabilitation techniques into a dementia-specific, bio-behavioural-environmental intervention. Methods:  A parallel-group randomised controlled pilot trial was conducted in Sydney, Australia, targeting community-dwelling people with amnestic mild cognitive impairment or mild/moderate stages of dementia and their carer (n = 18 dyads). I-HARP comprised: up to 12 home visits by registered nurse, occupational therapist, and psychologist, tailored to the individual client's needs;  < A$1000 for home modification/assistive devices; and individual carer support, all provided over four months. Additional allied health services were recommended when necessary. Clients' daily activities, mobility, mood, caregiver burden, and quality of life were assessed at baseline, four months and 12 months. Semi-structured interviews were conducted with I-HARP participants post intervention. Results:  Of 51 dyads who expressed interest in participation, 25 were eligible, with 76% consent rate (19/25 eligible dyads consented), and high adherence to the program (all nine intervention group participants completed and complied). Challenges included: need for better carer and allied health support, with more targeted recruitment points to speed up the process. The I-HARP group showed favourable effects across most outcomes at short-term (4 months) and longer-term (12 months) assessments. However, wide Confidence Intervals (CIs) point to the degree of uncertainty around interpretation of these results. Conclusion:  The delivery of I-HARP, a dementia-specific reablement program and the trial design concerning randomisation, screening and consent procedures, were deemed feasible, acceptable and appropriate for the target population group. Building on the success and lessons from the pilot, a larger trial is currently underway.",2020,The I-HARP group showed favourable effects across most outcomes at short-term (4 months) and longer-term (12 months) assessments.,"['51 dyads who expressed interest in participation, 25 were eligible, with 76% consent rate (19/25 eligible dyads consented), and high adherence to the program (all nine intervention group participants completed and complied', 'Sydney, Australia, targeting community-dwelling people with amnestic mild cognitive impairment or mild/moderate stages of dementia and their carer (n\u2009=\u200918 dyads', 'people with cognitive and functional decline']","['interdisciplinary Home-bAsed Reablement Program (I-HARP', 'interdisciplinary home-based reablement program (I-HARP']","[""Clients' daily activities, mobility, mood, caregiver burden, and quality of life""]","[{'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0084084', 'cui_str': 'pleiotropin'}]","[{'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0034380'}]",18.0,0.113218,The I-HARP group showed favourable effects across most outcomes at short-term (4 months) and longer-term (12 months) assessments.,"[{'ForeName': 'Yun-Hee', 'Initials': 'YH', 'LastName': 'Jeon', 'Affiliation': 'Susan Wakil School of Nursing and Midwifery, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Luisa', 'Initials': 'L', 'LastName': 'Krein', 'Affiliation': 'Susan Wakil School of Nursing and Midwifery, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Judy M', 'Initials': 'JM', 'LastName': 'Simpson', 'Affiliation': 'Sydney School of Public Health, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Sarah L', 'Initials': 'SL', 'LastName': 'Szanton', 'Affiliation': 'Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Lindy', 'Initials': 'L', 'LastName': 'Clemson', 'Affiliation': 'Faculty of Health Sciences, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Sharon L', 'Initials': 'SL', 'LastName': 'Naismith', 'Affiliation': 'Healthy Brain Ageing Program, Brain and Mind Centre, Charles Perkins Centre and School of Psychology, Faculty of Science, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Lee-Fay', 'Initials': 'LF', 'LastName': 'Low', 'Affiliation': 'Faculty of Health Sciences, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Loren', 'Initials': 'L', 'LastName': 'Mowszowski', 'Affiliation': 'Healthy Brain Ageing Program, Brain and Mind Centre and School of Psychology, Faculty of Science, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Gonski', 'Affiliation': 'Division of Aged and Extended Care (Southcare), Sutherland Hospital, South Eastern Sydney Local Health District, Sutherland, Australia.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Norman', 'Affiliation': 'Curtin University, Perth, Australia.'}, {'ForeName': 'Laura N', 'Initials': 'LN', 'LastName': 'Gitlin', 'Affiliation': 'College of Nursing and Health Professions, Drexel University, Philadelphia, PA, USA.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Brodaty', 'Affiliation': 'School of Psychiatry, UNSW Sydney, CHeBA (Centre for Healthy Brain Ageing) and Dementia Centre for Research Collaboration, Australia.'}]",Aging & mental health,['10.1080/13607863.2019.1642298']
3630,32001798,"Daratumumab plus lenalidomide and dexamethasone in relapsed/refractory multiple myeloma: extended follow-up of POLLUX, a randomized, open-label, phase 3 study.","In POLLUX, daratumumab (D) plus lenalidomide/dexamethasone (Rd) reduced the risk of disease progression or death by 63% and increased the overall response rate (ORR) versus Rd in relapsed/refractory multiple myeloma (RRMM). Updated efficacy and safety after >3 years of follow-up are presented. Patients (N = 569) with ≥1 prior line received Rd (lenalidomide, 25 mg, on Days 1-21 of each 28-day cycle; dexamethasone, 40 mg, weekly) ± daratumumab at the approved dosing schedule. Minimal residual disease (MRD) was assessed by next-generation sequencing. After 44.3 months median follow-up, D-Rd prolonged progression-free survival (PFS) in the intent-to-treat population (median 44.5 vs 17.5 months; HR, 0.44; 95% CI, 0.35-0.55; P < 0.0001) and in patient subgroups. D-Rd demonstrated higher ORR (92.9 vs 76.4%; P < 0.0001) and deeper responses, including complete response or better (56.6 vs 23.2%; P < 0.0001) and MRD negativity (10 -5 ; 30.4 vs 5.3%; P < 0.0001). Median time to next therapy was prolonged with D-Rd (50.6 vs 23.1 months; HR, 0.39; 95% CI, 0.31-0.50; P < 0.0001). Median PFS on subsequent line of therapy (PFS2) was not reached with D-Rd versus 31.7 months with Rd (HR, 0.53; 95% CI, 0.42-0.68; P < 0.0001). No new safety concerns were reported. These data support using D-Rd in patients with RRMM after first relapse.",2020,"D-Rd demonstrated higher ORR (92.9 vs 76.4%; P < 0.0001) and deeper responses, including complete response or better (56.6 vs 23.2%; P < 0.0001) and MRD negativity (10 -5 ; 30.4 vs 5.3%; P < 0.0001).","['Patients (N\u2009=\u2009569) with ≥1 prior line received', 'relapsed/refractory multiple myeloma']","['Rd (lenalidomide', 'POLLUX, daratumumab (D) plus lenalidomide/dexamethasone (Rd', 'Daratumumab plus lenalidomide and dexamethasone', 'dexamethasone, 40\u2009mg, weekly)\u2009±\u2009daratumumab']","['Median time to next therapy', 'D-Rd prolonged progression-free survival (PFS', 'risk of disease progression or death', 'MRD negativity', 'Minimal residual disease (MRD', 'overall response rate (ORR', 'ORR', 'Median PFS on subsequent line of therapy (PFS2']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0026764', 'cui_str': 'Myelomatosis'}]","[{'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C2346801', 'cui_str': 'daratumumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0242596', 'cui_str': 'Minimal Disease, Residual'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}]",569.0,0.152505,"D-Rd demonstrated higher ORR (92.9 vs 76.4%; P < 0.0001) and deeper responses, including complete response or better (56.6 vs 23.2%; P < 0.0001) and MRD negativity (10 -5 ; 30.4 vs 5.3%; P < 0.0001).","[{'ForeName': 'Nizar J', 'Initials': 'NJ', 'LastName': 'Bahlis', 'Affiliation': 'University of Calgary, Charbonneau Cancer Research Institute, Calgary, AB, Canada. nbahlis@ucalgary.ca.'}, {'ForeName': 'Meletios A', 'Initials': 'MA', 'LastName': 'Dimopoulos', 'Affiliation': 'The National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Darrell J', 'Initials': 'DJ', 'LastName': 'White', 'Affiliation': 'QEII Health Sciences Center and Dalhousie University, Halifax, NS, Canada.'}, {'ForeName': 'Lotfi', 'Initials': 'L', 'LastName': 'Benboubker', 'Affiliation': ""Service d'Hématologie et Thérapie Cellulaire, Hôpital Bretonneau, Centre Hospitalier Régional Universitaire (CHRU), Tours, France.""}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Cook', 'Affiliation': ""St James's Institute of Oncology, Leeds Teaching Hospitals National Health Service Trust and University of Leeds, Leeds, UK.""}, {'ForeName': 'Merav', 'Initials': 'M', 'LastName': 'Leiba', 'Affiliation': 'Assuta University Hospital, Faculty of Health Science, Ben-Gurion University of the Negev, Beersheba, Israel.'}, {'ForeName': 'P Joy', 'Initials': 'PJ', 'LastName': 'Ho', 'Affiliation': 'Institute of Haematology, Royal Prince Alfred Hospital, Camperdown, NSW, Australia.'}, {'ForeName': 'Kihyun', 'Initials': 'K', 'LastName': 'Kim', 'Affiliation': 'Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Takezako', 'Affiliation': 'Department of Hematology, National Hospital Organization Disaster Medical Center of Japan, Tachikawa, Japan.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Moreau', 'Affiliation': 'Hematology, University Hospital Hôtel-Dieu, Nantes, France.'}, {'ForeName': 'Jonathan L', 'Initials': 'JL', 'LastName': 'Kaufman', 'Affiliation': 'Winship Cancer Institute, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Krevvata', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Chiu', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Qin', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Okonkwo', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, NJ, USA.'}, {'ForeName': 'Sonali', 'Initials': 'S', 'LastName': 'Trivedi', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Ukropec', 'Affiliation': 'Janssen Global Medical Affairs, Horsham, PA, USA.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Qi', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Jesus', 'Initials': 'J', 'LastName': 'San-Miguel', 'Affiliation': 'Clínica Universidad de Navarra-Centro de Investigación Médica Aplicada, Instituto de Investigación Sanitaria de Navarra, Centro de Investigación Biomédica en Red de Cáncer, Pamplona, Spain.'}]",Leukemia,['10.1038/s41375-020-0711-6']
3631,31728714,"The effect of itraconazole on the pharmacokinetics of lorlatinib: results of a phase I, open-label, crossover study in healthy participants.","Background The third-generation tyrosine kinase inhibitor lorlatinib is approved for the treatment of ALK-positive metastatic NSCLC. CYP3A plays a major role in lorlatinib metabolism; therefore, a drug-drug interaction study was warranted to evaluate the impact of the strong CYP3A inhibitor, itraconazole, on lorlatinib plasma exposure. Methods This phase 1, open-label, 2-period, crossover study estimated the effects of itraconazole on the plasma pharmacokinetics and safety of lorlatinib in healthy participants (NCT02838264). Single-dose lorlatinib 50 mg (n = 2), 75 mg (n = 2) and 100 mg (n = 12) was administered in Period 1. In Period 2, itraconazole oral solution 200 mg/day was administered on Days 1-11, and single-dose lorlatinib on Day 5. Blood samples were collected up to 168 h after lorlatinib dosing. Results During daily dosing with itraconazole (Period 2), the ratios of the adjusted geometric means for area under the plasma concentration-time profile extrapolated to infinity (AUC inf ) and maximum plasma concentration (C max ) of single-dose lorlatinib 100 mg were 141.79% (90% confidence interval, 128.71%, 156.21%) and 124.39% (110.20%, 140.41%), respectively, compared with Period 1 (lorlatinib alone). Lorlatinib was well tolerated alone and with itraconazole. No serious adverse events or withdrawals were reported. Conclusions Co-administration of itraconazole and lorlatinib increased the plasma exposure of lorlatinib relative to lorlatinib alone in healthy participants. Therefore, concomitant use of lorlatinib with strong CYP3A inhibitors should be avoided. If this combination is unavoidable, the starting dose of lorlatinib should be reduced from 100 mg to 75 mg.",2020,No serious adverse events or withdrawals were reported.,"['healthy participants', 'healthy participants (NCT02838264']","['itraconazole', 'Single-dose lorlatinib 50']","['plasma pharmacokinetics and safety of lorlatinib', 'Blood samples', 'plasma concentration-time profile extrapolated to infinity (AUC inf ) and maximum plasma concentration (C max ']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0064113', 'cui_str': 'Itraconazole'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4080091'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4080091'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0806909', 'cui_str': 'Max'}]",,0.0543598,No serious adverse events or withdrawals were reported.,"[{'ForeName': 'Maulik', 'Initials': 'M', 'LastName': 'Patel', 'Affiliation': 'Pfizer Inc., La Jolla, CA, USA. maulikp03@gmail.com.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Pfizer Oncology, New York, NY, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'McGrory', 'Affiliation': 'Pfizer Inc., Collegeville, PA, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': ""O'Gorman"", 'Affiliation': 'Pfizer Oncology, Groton, CT, USA.'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Nepal', 'Affiliation': 'Pfizer Inc., Collegeville, PA, USA.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Ginman', 'Affiliation': 'Pfizer Inc., South Lyon, MI, USA.'}, {'ForeName': 'Yazdi K', 'Initials': 'YK', 'LastName': 'Pithavala', 'Affiliation': 'Pfizer Oncology, La Jolla, CA, USA.'}]",Investigational new drugs,['10.1007/s10637-019-00872-7']
3632,31993753,Prevention of oral mucositis with cryotherapy in children undergoing hematopoietic stem cell transplantations-a feasibility study and randomized controlled trial.,"PURPOSE


To evaluate the feasibility of oral cryotherapy (OC) in children and to investigate if OC reduces the incidence of severe oral mucositis (OM), oral pain, and opioid use in children undergoing hematopoietic stem cell transplantation (HSCT).
METHODS


Fifty-three children, 4-17 years old, scheduled for HSCT in Sweden were included and randomized to OC or control using a computer-generated list. OC instructions were to cool the mouth with ice for as long as possible during chemotherapy infusions with an intended time of ≥ 30 min. Feasibility criteria in the OC group were as follows: (1) compliance ≥ 70%; (2) considerable discomfort during OC < 20%; (3) no serious adverse events; and (4) ice administered to all children. Grade of OM and oral pain was recorded daily using the WHO-Oral Toxicity Scale (WHO-OTS), Children's International Oral Mucositis Evaluation Scale, and Numerical Rating Scale. Use of opioids was collected from the medical records.
RESULTS


Forty-nine children (mean age 10.5 years) were included in analysis (OC = 26, control = 23). The feasibility criteria were not met. Compliance was poor, especially for the younger children, and only 15 children (58%) used OC as instructed. Severe OM (WHO-OTS ≥ 3) was recorded in 26 children (OC = 15, control = 11). OC did not reduce the incidence of severe OM, oral pain, or opioid use.
CONCLUSION


The feasibility criteria were not met, and the RCT could not show that OC reduces the incidence of severe OM, oral pain, or opioid use in pediatric patients treated with a variety of conditioning regimens for HSCT.
TRIAL REGISTRATION


ClinicalTrials.gov id: NCT01789658.",2020,"OC did not reduce the incidence of severe OM, oral pain, or opioid use.
","['Forty-nine children (mean age 10.5\xa0years', 'children undergoing hematopoietic stem cell transplantations', 'Fifty-three children, 4-17\xa0years old, scheduled for HSCT in Sweden', 'children undergoing hematopoietic stem cell transplantation (HSCT']","['oral cryotherapy (OC', 'OC or control using a computer-generated list', 'cryotherapy']","['severe OM, oral pain', 'incidence of severe OM, oral pain, or opioid use', 'Grade of OM and oral pain', ""WHO-Oral Toxicity Scale (WHO-OTS), Children's International Oral Mucositis Evaluation Scale, and Numerical Rating Scale"", 'severe oral mucositis (OM), oral pain, and opioid use']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517521', 'cui_str': '10.5'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0472699', 'cui_str': 'Hematopoietic Stem Cell Transplantation'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C4551716', 'cui_str': 'Cryotherapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0009622', 'cui_str': 'Computers'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0221776', 'cui_str': 'Painful mouth (finding)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1142072', 'cui_str': 'Oral toxicity'}, {'cui': 'C0222045'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1568868', 'cui_str': 'Oral Mucositis'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",53.0,0.0556696,"OC did not reduce the incidence of severe OM, oral pain, or opioid use.
","[{'ForeName': 'Tove', 'Initials': 'T', 'LastName': 'Kamsvåg', 'Affiliation': ""Department of Women's and Children's Health, Pediatric Oncology, Uppsala University, Uppsala, Sweden. tove.kamsvag_magnusson@kbh.uu.se.""}, {'ForeName': 'Anncarin', 'Initials': 'A', 'LastName': 'Svanberg', 'Affiliation': 'Department of Medical Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Karin Garming', 'Initials': 'KG', 'LastName': 'Legert', 'Affiliation': 'Department of Dental Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Arvidson', 'Affiliation': ""Department of Women's and Children's Health, Pediatric Oncology, Uppsala University, Uppsala, Sweden.""}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'von Essen', 'Affiliation': ""Department of Women's and Children's Health, Clinical Psychology in Healthcare, Uppsala University, Uppsala, Sweden.""}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Mellgren', 'Affiliation': 'Department of Pediatric Oncology, Institute of Clinical Sciences, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Jacek', 'Initials': 'J', 'LastName': 'Toporski', 'Affiliation': 'Department of Clinical Sciences, Pediatric Oncology and Hematology, University of Lund, Lund, Sweden.'}, {'ForeName': 'Jacek', 'Initials': 'J', 'LastName': 'Winiarski', 'Affiliation': ""Department of Pediatrics, Astrid Lindgren's Children's Hospital, Karolinska University Hospital, Huddinge, Stockholm, Sweden.""}, {'ForeName': 'Gustaf', 'Initials': 'G', 'LastName': 'Ljungman', 'Affiliation': ""Department of Women's and Children's Health, Pediatric Oncology, Uppsala University, Uppsala, Sweden.""}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-019-05258-2']
3633,32195538,Single Nucleotide Polymorphisms Related to Lipoprotein Metabolism Are Associated with Blood Lipid Changes following Regular Avocado Intake in a Randomized Control Trial among Adults with Overweight and Obesity.,"BACKGROUND


Avocados are rich in unsaturated fat and fiber; clinical trials have investigated their effects on metabolic disease. There is high variability in individual changes following avocado consumption, which may be in part due to individual genetic differences.
OBJECTIVE


Secondary analyses of the Persea americana for Total Health (PATH) Study were used to examine how single nucleotide polymorphisms (SNPs) impact blood lipid changes following a daily meal containing avocado compared with control.
METHODS


Adults (n = 115, 37% male) aged 25-45 y with overweight and obesity were randomly assigned to receive a daily isocaloric meal with (intervention) or without (control) a standardized amount (males: 175 g; females: 140 g) of avocado for 12 wk. Control meals were higher in saturated fat (17% of energy compared with 7%) and lower in fiber (4 g compared with 16 g) than intervention meals. Whole venous blood was taken at baseline and 12 wk to determine total cholesterol (TC), high-density lipoprotein (HDL) cholesterol, and triglyceride (TG) concentrations. Seventeen SNPs in 10 genes related to lipoprotein metabolism were genotyped. Effects of SNP, diet, and SNP-diet interactions were determined using general linear models.
RESULTS


No group-by-time effects were detected for changes in TC (P = 0.96), HDL cholesterol (P = 0.28), or TG (P = 0.06) over 12 wk. Three SNP-diet interactions were associated with final TC concentrations: ANGPTL3-rs10889337 (P = 0.01), ANGPTL4-rs2278236 (P = 0.02), and CD36-rs10499859 (P = 0.01). SNPs in GCKR and LPL were associated with TC changes (P = 0.01). The interaction between GCKR-rs1260326 and diet was such that C-homozygotes receiving avocado (n = 23) had final TC concentrations that were significantly lower than the C-homozygotes in the control group (n = 20) (P = 0.02).
CONCLUSIONS


Results from these exploratory analyses indicate that avocado consumption may help manage dyslipidemia in adults with overweight and obesity; however, effectiveness may differ by genetic profile. Understanding the role of genetic variation in variability following dietary intervention can potentially inform personalized nutrition recommendations.",2020,"No group-by-time effects were detected for changes in TC (P = 0.96), HDL cholesterol (P = 0.28), or TG (P = 0.06) over 12 wk.","['115, 37% male) aged 25-45 y with overweight and obesity', 'Adults (n\xa0', 'Adults with Overweight and Obesity', 'adults with overweight and obesity']","['dietary intervention', 'daily isocaloric meal with (intervention) or without (control) a standardized amount (males: 175\xa0g; females: 140\xa0g) of avocado']","['Lipoprotein Metabolism', 'Blood Lipid Changes', 'final TC concentrations: ANGPTL3-rs10889337', 'changes in TC', 'final TC concentrations', 'HDL cholesterol', 'total cholesterol (TC), high-density lipoprotein (HDL) cholesterol, and triglyceride (TG) concentrations', 'TC changes', 'Total Health (PATH', 'lipoprotein metabolism']","[{'cui': 'C4517540', 'cui_str': '115 (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0330230', 'cui_str': 'Avocado'}]","[{'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0005768'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol, HDL2'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0023822', 'cui_str': 'High Density Lipoprotein Cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",,0.0342006,"No group-by-time effects were detected for changes in TC (P = 0.96), HDL cholesterol (P = 0.28), or TG (P = 0.06) over 12 wk.","[{'ForeName': 'Bridget A', 'Initials': 'BA', 'LastName': 'Hannon', 'Affiliation': 'Division of Nutritional Sciences, University of Illinois at Urbana-Champaign, Urbana, IL, USA.'}, {'ForeName': 'Caitlyn G', 'Initials': 'CG', 'LastName': 'Edwards', 'Affiliation': 'Division of Nutritional Sciences, University of Illinois at Urbana-Champaign, Urbana, IL, USA.'}, {'ForeName': 'Sharon V', 'Initials': 'SV', 'LastName': 'Thompson', 'Affiliation': 'Division of Nutritional Sciences, University of Illinois at Urbana-Champaign, Urbana, IL, USA.'}, {'ForeName': 'Ginger E', 'Initials': 'GE', 'LastName': 'Reeser', 'Affiliation': 'Department of Kinesiology and Community Health, University of Illinois at Urbana-Champaign, Urbana, IL, USA.'}, {'ForeName': 'Nicholas A', 'Initials': 'NA', 'LastName': 'Burd', 'Affiliation': 'Division of Nutritional Sciences, University of Illinois at Urbana-Champaign, Urbana, IL, USA.'}, {'ForeName': 'Hannah D', 'Initials': 'HD', 'LastName': 'Holscher', 'Affiliation': 'Division of Nutritional Sciences, University of Illinois at Urbana-Champaign, Urbana, IL, USA.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Teran-Garcia', 'Affiliation': 'Division of Nutritional Sciences, University of Illinois at Urbana-Champaign, Urbana, IL, USA.'}, {'ForeName': 'Naiman A', 'Initials': 'NA', 'LastName': 'Khan', 'Affiliation': 'Division of Nutritional Sciences, University of Illinois at Urbana-Champaign, Urbana, IL, USA.'}]",The Journal of nutrition,['10.1093/jn/nxaa054']
3634,31892650,Better before-better after: efficacy of prehabilitation for older patients with osteoarthritis awaiting total hip replacement-a study protocol for a randomised controlled trial in South-Eastern Norway.,"INTRODUCTION


Health professions need to prepare for the increase of older patients with osteoarthritis requiring health services including those requiring total joint arthroplasty (TJA). The primary objective of this study is to assess the effect of a tailored prehabilitation programme of older patients awaiting primary surgery for total hip replacement on physical function measured by walking speed within 1 week after intervention as well as 6 weeks and 3 months after TJA surgery.
METHODS AND ANALYSIS


This is a single-blinded randomised controlled trial. The participants are 70 years or older, scheduled for primary total hip replacement due to late stage osteoarthritis. The intervention group will receive patient education and exercise for 6-12 weeks. The control group will receive care as usual. The primary outcome is gait speed. Secondary outcomes are lower body strength, mobility, aerobic capacity, activity of daily living, length of stay at the hospital, referral to an inpatient rehabilitation clinic, pain, quality of life and cost-effectiveness. Estimated sample size is 150 participants randomised into the two arms. The data will be analysed following the intention-to-treat principle with methods for repeated measurements.
ETHICS AND DISSEMINATION


The project proposal has been approved by The Regional Committee for Medical Research Ethics in South Norway (ref no. 2018/503). The results will be published in peer-reviewed articles.
TRIAL REGISTRATION NUMBER


NCT03602105.",2019,"Secondary outcomes are lower body strength, mobility, aerobic capacity, activity of daily living, length of stay at the hospital, referral to an inpatient rehabilitation clinic, pain, quality of life and cost-effectiveness.","['older patients with osteoarthritis awaiting total hip replacement-a study protocol for a randomised controlled trial in South-Eastern Norway', 'older patients awaiting primary surgery for total hip replacement on physical function', '150 participants randomised into the two arms', 'older patients with osteoarthritis requiring health services including those requiring total joint arthroplasty (TJA', 'participants are 70 years or older, scheduled for primary total hip replacement due to late stage osteoarthritis']","['patient education and exercise', 'tailored prehabilitation programme']","['gait speed', 'lower body strength, mobility, aerobic capacity, activity of daily living, length of stay at the hospital, referral to an inpatient rehabilitation clinic, pain, quality of life and cost-effectiveness']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0040508', 'cui_str': 'Hip Replacement, Total'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0028423', 'cui_str': 'Kingdom of Norway'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0018747', 'cui_str': 'Health Services'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0003893', 'cui_str': 'Arthroplasty'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C1279941', 'cui_str': 'Late stage (qualifier value)'}]","[{'cui': 'C0030688', 'cui_str': 'Education of Patients'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C1268088', 'cui_str': 'Lower body'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C3839785', 'cui_str': 'Rehabilitation clinic (environment)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0034380'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",150.0,0.152471,"Secondary outcomes are lower body strength, mobility, aerobic capacity, activity of daily living, length of stay at the hospital, referral to an inpatient rehabilitation clinic, pain, quality of life and cost-effectiveness.","[{'ForeName': 'Odd-Einar', 'Initials': 'OE', 'LastName': 'Svinøy', 'Affiliation': 'Faculty of Health Sciences, Department of Physiotherapy, Oslo Metropolitan University, Oslo, Norway oddeina@oslomet.no.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Bergland', 'Affiliation': 'Faculty of Health Sciences, Department of Physiotherapy, Oslo Metropolitan University, Oslo, Norway.'}, {'ForeName': 'May Arna', 'Initials': 'MA', 'LastName': 'Risberg', 'Affiliation': 'Department of Sports Medicine, Norwegian School of Sport Sciences, Oslo, Norway.'}, {'ForeName': 'Are Hugo', 'Initials': 'AH', 'LastName': 'Pripp', 'Affiliation': 'Faculty of Health Sciences, Oslo Metropolitan University, Oslo, Norway.'}, {'ForeName': 'Gunvor', 'Initials': 'G', 'LastName': 'Hilde', 'Affiliation': 'Faculty of Health Sciences, Department of Physiotherapy, Oslo Metropolitan University, Oslo, Norway.'}]",BMJ open,['10.1136/bmjopen-2019-031626']
3635,31662372,A Randomised Trial Examining Cardiovascular Morbidity and All-Cause Mortality 24 years Following General Health Checks: the Ebeltoft Health Promotion Project (EHPP).,"INTRODUCTION


Global prevalence of risk factors for cardiovascular disease (CVD) and all-cause mortality is increasing. Treatments are available but can only be implemented if individuals at risk are identified. General health checks have been suggested to facilitate this process.
OBJECTIVES


To examine the long-term effect of population-based general health checks on CVD and all-cause mortality.
DESIGN AND SETTING


The Ebeltoft Health Promotion Project (EHPP) is a parallel randomised controlled trial in a Danish primary care setting.
PARTICIPANTS


The EHPP enrolled individuals registered in the Civil Registration System as (1) inhabitants of Ebeltoft municipality, (2) registered with a general practitioner (GP) participating in the study and (3) aged 30-49 on 1 January 1991. A total of 3464 individuals were randomised as invitees (n=2000) or non-invitees (n=1464). Of the invitees, 493 declined. As an external control group, we included 1 511 498 Danes living outside the municipality of Ebeltoft.
INTERVENTIONS


Invitees were offered a general health check and, if test-results were abnormal, recommended a 15-45 min consultation with their GP. Non-invitees in Ebeltoft received a questionnaire at baseline and were offered a general health check at year 5. The external control group, that is, the remaining Danish population, received routine care only.
OUTCOME MEASURES


HRs for CVD and all-cause mortality.
RESULTS


Every individual randomised was analysed. When comparing invitees to non-invitees within the municipality of Ebeltoft, we found no significant effect of general health checks on CVD (HR=1.11 (0.88; 1.41)) or all-cause mortality (HR=0.93 (0.75; 1.16)). When comparing invitees to the remaining Danish population, we found similar results for CVD (adjusted HR=0.99 (0.86; 1.13)) and all-cause mortality (adjusted HR=0.96 (0.85; 1.09)).
CONCLUSION


We found no effect of general health checks offered to the general population on CVD or all-cause mortality.
TRIAL REGISTRATION NUMBER


NCT00145782; 2015-57-0002; 62908, 187.",2019,A total of 3464 individuals were randomised as invitees (n=2000) or non-invitees (n=1464).,"['The EHPP enrolled individuals registered in the Civil Registration System as (1) inhabitants of Ebeltoft municipality, (2) registered with a general practitioner (GP) participating in the study and (3) aged 30-49 on 1 January 1991', '3464 individuals were randomised as invitees (n=2000) or non-invitees (n=1464', 'included 1\u2009511\u2009498 Danes living outside the municipality of Ebeltoft', '2015-57-0002; 62908, 187']","['Ebeltoft Health Promotion Project (EHPP', 'routine care only', 'population-based general health checks']","['general health checks on CVD', 'cause mortality', 'HRs for CVD and all-cause mortality']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0600182'}, {'cui': 'C0017319', 'cui_str': 'Physicians, General Practice'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0337800', 'cui_str': 'Danes (ethnic group)'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C4517618', 'cui_str': '187 (qualifier value)'}]","[{'cui': 'C0018738', 'cui_str': 'Health Promotion'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",493.0,0.0832507,A total of 3464 individuals were randomised as invitees (n=2000) or non-invitees (n=1464).,"[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Bernstorff', 'Affiliation': 'Department of Public Health, Research Unit for General Practice, Aarhus University, Aarhus, Denmark martinbernstorff@gmail.com.'}, {'ForeName': 'Pia', 'Initials': 'P', 'LastName': 'Deichgræber', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Niels Henrik', 'Initials': 'NH', 'LastName': 'Bruun', 'Affiliation': 'Department of Public Health, Research Unit for General Practice, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Else-Marie', 'Initials': 'EM', 'LastName': 'Dalsgaard', 'Affiliation': 'Department of Public Health, Research Unit for General Practice, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Fenger-Grøn', 'Affiliation': 'Department of Public Health, Research Unit for General Practice, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Lauritzen', 'Affiliation': 'Department of Public Health, Research Unit for General Practice, Aarhus University, Aarhus, Denmark.'}]",BMJ open,['10.1136/bmjopen-2019-030400']
3636,31996605,A Clinical Trial Investigating Telehealth and In-Person Social Communication Skills Training for People With Traumatic Brain Injury: Participant-Reported Communication Outcomes.,"OBJECTIVE


To investigate the efficacy of telehealth-based and in-person social communication skills training (TBIconneCT) for people with moderate to severe traumatic brain injury (TBI) based on outcomes reported by the survivor and a close communication partner.
SETTING


Australia. Two telehealth dyads were located outside Australia.
PARTICIPANTS


Adults (n = 51) at least 6 months after moderate-severe TBI with social communication skills deficits, and their usual communication partners (family members, friends, or paid carers).
DESIGN


Partially randomized controlled trial, with a telehealth intervention group, in-person intervention group, and a historical control group.
MAIN MEASURES


La Trobe Communication Questionnaire (LCQ) (total score, and number of items with perceived positive change). Both self- and other-reports.
RESULTS


Trained participants had significantly more items with perceived positive change than did historical controls. A medium effect size in the sample was observed for improvements in total score reported by trained communication partners after treatment. Comparisons between telehealth and in-person groups found medium to large effect sizes in the sample, favoring the telehealth group on some LCQ variables.
CONCLUSIONS


Whether delivered via telehealth or in-person, social communication skills training led to perceived positive change in communication skills. It was unexpected that outcomes for the telehealth group were better than for the in-person group on some variables.",2020,"Comparisons between telehealth and in-person groups found medium to large effect sizes in the sample, favoring the telehealth group on some LCQ variables.
","['People With Traumatic Brain Injury', 'Australia', 'people with moderate to severe traumatic brain injury (TBI', 'Adults (n = 51']","['historical control group', 'telehealth-based and in-person social communication skills training (TBIconneCT', 'telehealth intervention', 'Person Social Communication Skills Training']","['total score', 'La Trobe Communication Questionnaire (LCQ) (total score, and number of items with perceived positive change']","[{'cui': 'C0876926', 'cui_str': 'TBI (Traumatic Brain Injury)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0588407', 'cui_str': 'Communication skills training (procedure)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",,0.101985,"Comparisons between telehealth and in-person groups found medium to large effect sizes in the sample, favoring the telehealth group on some LCQ variables.
","[{'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Rietdijk', 'Affiliation': 'Faculty of Health Sciences, The University of Sydney, Australia (Ms Rietdijk and Drs Power, Attard, Heard, and Togher); and Graduate School of Health, The University of Technology Sydney, Australia (Dr Power).'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Power', 'Affiliation': ''}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Attard', 'Affiliation': ''}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Heard', 'Affiliation': ''}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Togher', 'Affiliation': ''}]",The Journal of head trauma rehabilitation,['10.1097/HTR.0000000000000554']
3637,31832912,Varying Effect of a Randomized Toddler Home Safety Promotion Intervention Trial by Initial Home Safety Problems.,"OBJECTIVES


Toddlers are vulnerable to unintentional injuries. A safety intervention targeting low-income families of toddlers, was effective at improving home safety. The current study examined whether the effect varies by initial home safety problems.
METHODS


277 mother-toddler dyads recruited in the Mid-Atlantic region of the United States during 2007-2010 were randomized into safety promotion (n = 91) or attention-control groups (n = 186). Observers rated participants' homes with a 9-item safety problem checklist at baseline, and at 6- and 12-months follow-up. Initial home safety problems were categorized as multiple (≥ 4 problems) and none/few (< 4). Linear mixed models assessed the moderating effect with a three-way interaction (time, intervention, and initial safety problems).
RESULTS


At 12 months, the intervention effect was stronger among families with multiple initial problems than no/few initial problems, with a reduction of 1.55 more problems among the families with multiple problems, compared to the families with no/few problems (b = - 1.55, SE = 0.62, p = 0.013).
CONCLUSIONS


Interventions targeting families with multiple safety problems may be more effective than universal programming.",2020,"At 12 months, the intervention effect was stronger among families with multiple initial problems than no/few initial problems, with a reduction of 1.55 more problems among the families with multiple problems, compared to the families with no/few problems (b = - 1.55, SE = 0.62, p = 0.013).
","['277 mother-toddler dyads recruited in the\xa0Mid-Atlantic region\xa0of the United\xa0States during 2007-2010 were randomized into', ""Observers rated participants' homes with a""]",['safety promotion (n\u2009=\u200991) or attention-control groups'],['9-item safety problem checklist'],"[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0682053', 'cui_str': 'Toddler (qualifier value)'}, {'cui': 'C0026053', 'cui_str': 'Middle Atlantic States'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}]",,0.037765,"At 12 months, the intervention effect was stronger among families with multiple initial problems than no/few initial problems, with a reduction of 1.55 more problems among the families with multiple problems, compared to the families with no/few problems (b = - 1.55, SE = 0.62, p = 0.013).
","[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Pediatrics, University of Maryland School of Medicine, 737\xa0W. Lombard Street, Baltimore, MD, 21201, USA. yan.wang@som.umaryland.edu.'}, {'ForeName': 'Andrea C', 'Initials': 'AC', 'LastName': 'Gielen', 'Affiliation': 'Department of Health, Behaviour and Society, Johns Hopkins Centre for Injury Research and Policy, Johns Hopkins Bloomberg School of Public Health, 624\xa0N. Broadway, Hampton House 554, Baltimore, MD, 21205, USA.'}, {'ForeName': 'Laurence S', 'Initials': 'LS', 'LastName': 'Magder', 'Affiliation': 'Department of Epidemiology and Public Health, University of Maryland School of Medicine, Howard Hall Building, Baltimore, MD, 21201, USA.'}, {'ForeName': 'Erin R', 'Initials': 'ER', 'LastName': 'Hager', 'Affiliation': 'Department of Pediatrics, University of Maryland School of Medicine, 737\xa0W. Lombard Street, Baltimore, MD, 21201, USA.'}, {'ForeName': 'Maureen M', 'Initials': 'MM', 'LastName': 'Black', 'Affiliation': 'Department of Pediatrics, University of Maryland School of Medicine, 737\xa0W. Lombard Street, Baltimore, MD, 21201, USA.'}]",Maternal and child health journal,['10.1007/s10995-019-02845-x']
3638,32077229,Comparison of two different minimally invasive percutaneous nephrostomy sheaths for the treatment of staghorn stones.,"OBJECTIVE


To compare the safety and effectiveness of using a conventional nephrostomy sheath (NS) vs using a new NS with suction and evacuation functions in minimally invasive percutaneous nephrolithotomy (MPCNL) for the treatment of staghorn stones.
PATIENTS AND METHODS


A prospective and randomised study of 60 patients with staghorn stones randomly assigned into two groups of 30 patients. One group underwent MPCNL using conventional NS, whereas the other group underwent MPCNL with suction-evacuation NS (SENS). Patient demographics, stone characteristics, intraoperative data, perioperative data, and surgical results were collected and analysed.
RESULTS


The patient demographics and stone characteristics were similar amongst the two groups. The SENS group had a significantly lower peak and a significantly lower average renal pelvic pressure (RPP) throughout the procedure. The SENS group was more efficient for stone removal and had a much shorter stone treatment time, a lesser use of the stone extractor, and ultimately a higher stone-free rate (SFR). The effects of a lower RPP and shorter stone treatment time translated into less severe postoperative complications as measured per modified Clavien grade.
CONCLUSION


Using SENS in MPCNL for the treatment of staghorn stones has the advantages of lower RPP, increased effectiveness in stone retrieval, decreased surgery related complications, and an improved SFR.",2020,"The SENS group was more efficient in removing stones and had a much shorter stone treatment time, a lower-frequency use of the stone extractor, and an ultimately higher stone-free rate (SFR).","['Sixty patients with staghorn stones', 'staghorn stones']","['conventional nephrostomy sheath versus using a new access sheath with suction and evacuation functions', 'MPCNL with suction-evacuation nephrostomy sheaths (SENS', 'SENS', 'minimally invasive percutaneous nephrolithotomy (MPCNL', 'minimally invasive percutaneous nephrostomy sheaths', 'MPCNL using conventional nephrostomy sheaths (CNS']","['average renal pelvic pressure (RPP', 'Patient demographics, stone characteristics, intraoperative data, perioperative data, and surgical results', 'patient demographics and stone characteristics', 'stone-free rate (SFR', 'safety and efficacy', 'shorter stone treatment time']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332249', 'cui_str': 'Staghorn (qualifier value)'}, {'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0278314', 'cui_str': 'Nephrostomy'}, {'cui': 'C0009653', 'cui_str': 'Condoms'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0038638', 'cui_str': 'Aspiration, Mechanical'}, {'cui': 'C1282573', 'cui_str': 'Evacuation procedure'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0162428', 'cui_str': 'Nephrolithotomy, Percutaneous'}, {'cui': 'C0564457', 'cui_str': 'Nephrostomy, Percutaneous'}]","[{'cui': 'C0030797', 'cui_str': 'Pelvic Region'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C1264665', 'cui_str': 'Substance fraction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",60.0,0.0399825,"The SENS group was more efficient in removing stones and had a much shorter stone treatment time, a lower-frequency use of the stone extractor, and an ultimately higher stone-free rate (SFR).","[{'ForeName': 'Guibin', 'Initials': 'G', 'LastName': 'Xu', 'Affiliation': 'Department of Urology, The Fifth Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Liang', 'Affiliation': 'Department of Urology, The Fifth Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Yongzhong', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': 'Department of Urology, The Fifth Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Xiezhao', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Urology, The Fifth Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Weiqing', 'Initials': 'W', 'LastName': 'Yang', 'Affiliation': 'Department of Urology, The Fifth Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Dehui', 'Initials': 'D', 'LastName': 'Lai', 'Affiliation': 'Department of Urology, The Fifth Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Haibo', 'Initials': 'H', 'LastName': 'Zhao', 'Affiliation': 'Department of Urology, The Fifth Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Xun', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Urology, The Fifth Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China.'}]",BJU international,['10.1111/bju.15031']
3639,31996411,A Randomized Trial of Distal Diuretics versus Dietary Sodium Restriction for Hypertension in Chronic Kidney Disease.,"BACKGROUND


Distal diuretics are considered less effective than loop diuretics in CKD. However, data to support this perception are limited.
METHODS


To investigate whether distal diuretics are noninferior to dietary sodium restriction in reducing BP in patients with CKD stage G3 or G4 and hypertension, we conducted a 6-week, randomized, open-label crossover trial comparing amiloride/hydrochlorothiazide (5 mg/50 mg daily) with dietary sodium restriction (60 mmol per day). Antihypertension medication was discontinued for a 2-week period before randomization. We analyzed effects on BP, kidney function, and fluid balance and related this to renal clearance of diuretics.
RESULTS


A total of 26 patients (with a mean eGFR of 39 ml/min per 1.73 m 2 ) completed both treatments. Dietary sodium restriction reduced sodium excretion from 160 to 64 mmol per day. Diuretics produced a greater reduction in 24-hour systolic BP (SBP; from 138 to 124 mm Hg) compared with sodium restriction (from 134 to 129 mm Hg), as well as a significantly greater effect on extracellular water, eGFR, plasma renin, and aldosterone. Both interventions resulted in a similar decrease in body weight and NT-proBNP. Neither approaches decreased albuminuria significantly, whereas diuretics did significantly reduce urinary angiotensinogen and  β 2-microglobulin excretion. Although lower eGFR and higher plasma indoxyl sulfate correlated with lower diuretic clearance, the diuretic effects on body weight and BP at lower eGFR were maintained. During diuretic treatment, higher PGE2 excretion correlated with lower free water clearance, and four patients developed mild hyponatremia.
CONCLUSIONS


Distal diuretics are noninferior to dietary sodium restriction in reducing BP and extracellular volume in CKD. Diuretic sensitivity in CKD is maintained despite lower diuretic clearance.
CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER


DD-study: Diet or Diuretics for Salt-sensitivity in Chronic Kidney Disease (DD), NCT02875886.",2020,"Diuretics produced a greater reduction in 24-hour systolic BP (SBP; from 138 to 124 mm Hg) compared with sodium restriction (from 134 to 129 mm Hg), as well as a significantly greater effect on extracellular water, eGFR, plasma renin, and aldosterone.","['patients with CKD stage G3 or G4 and hypertension', 'Hypertension in Chronic Kidney Disease', '26 patients (with a mean eGFR of 39 ml/min per 1.73 m 2 ) completed both treatments']","['Distal Diuretics versus Dietary Sodium Restriction', 'Diet or Diuretics', 'Diuretics', 'dietary sodium restriction', 'amiloride/hydrochlorothiazide']","['albuminuria', 'extracellular water, eGFR, plasma renin, and aldosterone', '24-hour systolic BP (SBP', 'urinary angiotensinogen and  β 2-microglobulin excretion', 'higher PGE2 excretion', 'body weight and NT-proBNP', 'mild hyponatremia', 'BP and extracellular volume in CKD', 'sodium excretion', 'Diuretic sensitivity', 'BP, kidney function, and fluid balance', 'body weight and BP at lower eGFR']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0037570', 'cui_str': 'Sodium, Dietary'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0012798', 'cui_str': 'Diuretics'}, {'cui': 'C0717400', 'cui_str': 'Amiloride / Hydrochlorothiazide'}]","[{'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0521119', 'cui_str': 'Extracellular (qualifier value)'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0035094', 'cui_str': 'Angiotensinogenase'}, {'cui': 'C0373535', 'cui_str': 'Aldosterone measurement (procedure)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0003017', 'cui_str': 'Hypertensinogen'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0012472', 'cui_str': 'prostaglandin E2 alpha'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C1963813', 'cui_str': 'NT-proBNP'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0020625', 'cui_str': 'Hyponatremia'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0012798', 'cui_str': 'Diuretics'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0016284', 'cui_str': 'Fluid Balance'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]",26.0,0.0169257,"Diuretics produced a greater reduction in 24-hour systolic BP (SBP; from 138 to 124 mm Hg) compared with sodium restriction (from 134 to 129 mm Hg), as well as a significantly greater effect on extracellular water, eGFR, plasma renin, and aldosterone.","[{'ForeName': 'Dominique M', 'Initials': 'DM', 'LastName': 'Bovée', 'Affiliation': 'Divisions of Nephrology and Transplantation.'}, {'ForeName': 'Wesley J', 'Initials': 'WJ', 'LastName': 'Visser', 'Affiliation': 'Dietetics, and.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Middel', 'Affiliation': 'Division of Pharmacology, Department of Pharmaceutical Sciences, University Utrecht, Utrecht, The Netherlands; and.'}, {'ForeName': 'Anneke', 'Initials': 'A', 'LastName': 'De Mik-van Egmond', 'Affiliation': 'Dietetics, and.'}, {'ForeName': 'Rick', 'Initials': 'R', 'LastName': 'Greupink', 'Affiliation': 'Department of Pharmacology and Toxicology, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Rosalinde', 'Initials': 'R', 'LastName': 'Masereeuw', 'Affiliation': 'Division of Pharmacology, Department of Pharmaceutical Sciences, University Utrecht, Utrecht, The Netherlands; and.'}, {'ForeName': 'Frans G M', 'Initials': 'FGM', 'LastName': 'Russel', 'Affiliation': 'Department of Pharmacology and Toxicology, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'A H Jan', 'Initials': 'AHJ', 'LastName': 'Danser', 'Affiliation': 'Vascular Medicine and Pharmacology, Department of Internal Medicine, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Zietse', 'Affiliation': 'Divisions of Nephrology and Transplantation.'}, {'ForeName': 'Ewout J', 'Initials': 'EJ', 'LastName': 'Hoorn', 'Affiliation': 'Divisions of Nephrology and Transplantation, e.j.hoorn@erasmusmc.nl.'}]",Journal of the American Society of Nephrology : JASN,['10.1681/ASN.2019090905']
3640,32154928,"NRG/RTOG 1122: A phase 2, double-blinded, placebo-controlled study of bevacizumab with and without trebananib in patients with recurrent glioblastoma or gliosarcoma.","BACKGROUND


Targeting vascular endothelial growth factor (VEGF) alone does not improve overall survival (OS) in recurrent glioblastoma (rGBM). The angiopoiein (Ang)-TIE2 system may play a role in tumor survival under VEGF inhibition. We conducted a phase 2, double-blinded, placebo-controlled trial of bevacizumab plus trebananib (a novel Fc fusion protein that sequesters Ang1/Ang2) over bevacizumab alone in rGBM.
METHODS


Patients ≥18 years of age with a Karnofsky performance status ≥70 and GBM or variants in first or second relapse were randomized to bevacizumab 10 mg/kg every 2 weeks plus trebananib 15 mg/kg every week or bevacizumab plus placebo. The primary endpoint was 6-month progression-free survival (PFS).
RESULTS


After an initial 6-patient lead-in cohort confirmed the safety of combining bevacizumab and trebananib, 115 eligible patients were randomized to the control (n = 58) or experimental treatment (n = 57). In the control arm, 6-month PFS was 41.1%, median survival time was 11.5 months (95% CI, 8.4-14.2 months), median PFS was 4.8 months (95% CI, 3.8-7.1 months), and radiographic response (RR) was 5.9%. In the experimental arm, 6-month PFS was 22.6%, median survival time was 7.5 months (95% CI, 6.8-10.1 months), median PFS was 4.2 months (95% CI, 3.7-5.6 months), and RR was 4.2%. The rate of severe toxicities was not significantly different between arms.
CONCLUSION


The combination of bevacizumab and trebananib was well tolerated but did not significantly improve 6-month PFS rate, PFS, or OS for patients with rGBM over bevacizumab alone. The shorter PFS in the experimental arm with a hazard ratio of 1.51 (P = .04) suggests that the addition of trebananib to bevacizumab is detrimental.",2020,"The combination of bevacizumab and trebananib was well tolerated but did not significantly improve 6-month PFS rate, PFS, or OS for patients with rGBM over bevacizumab alone.","['patients with recurrent glioblastoma or gliosarcoma', '115 eligible patients', 'Patients ≥18\xa0years of age with a Karnofsky performance status ≥70 and GBM or variants in first or second relapse']","['bevacizumab plus trebananib', 'bevacizumab 10\xa0mg/kg every 2\xa0weeks plus trebananib 15\xa0mg/kg every week or bevacizumab plus placebo', 'placebo', 'bevacizumab with and without trebananib', 'bevacizumab', 'bevacizumab and trebananib', 'angiopoiein']","['radiographic response (RR', '6-month PFS rate, PFS, or OS', 'overall survival (OS', 'rate of severe toxicities', 'shorter PFS', 'median survival time', '6-month progression-free survival (PFS', '6-month PFS', 'median PFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0017636', 'cui_str': 'Astrocytoma, Grade IV'}, {'cui': 'C0206726', 'cui_str': 'Sarcomatous Glioma'}, {'cui': 'C4517540', 'cui_str': '115 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0206065', 'cui_str': 'Karnofsky Scale'}, {'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C3660912', 'cui_str': 'trenananib'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",115.0,0.680496,"The combination of bevacizumab and trebananib was well tolerated but did not significantly improve 6-month PFS rate, PFS, or OS for patients with rGBM over bevacizumab alone.","[{'ForeName': 'Eudocia Q', 'Initials': 'EQ', 'LastName': 'Lee', 'Affiliation': ""Dana-Farber/Brigham and Women's Cancer Center, Boston, Massachusetts.""}, {'ForeName': 'Peixin', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'NRG Oncology Statistics and Data Management Center, American College of Radiology, Philadelphia, Pennsylvania.'}, {'ForeName': 'Patrick Y', 'Initials': 'PY', 'LastName': 'Wen', 'Affiliation': ""Dana-Farber/Brigham and Women's Cancer Center, Boston, Massachusetts.""}, {'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Gerstner', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Reardon', 'Affiliation': ""Dana-Farber/Brigham and Women's Cancer Center, Boston, Massachusetts.""}, {'ForeName': 'Kenneth D', 'Initials': 'KD', 'LastName': 'Aldape', 'Affiliation': 'Toronto General Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'deGroot', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Pan', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Jeffrey J', 'Initials': 'JJ', 'LastName': 'Raizer', 'Affiliation': 'Northwestern University, Evanston, Illinois.'}, {'ForeName': 'Lyndon J', 'Initials': 'LJ', 'LastName': 'Kim', 'Affiliation': 'Thomas Jefferson University Hospital, Philadelphia, Pennsylvania.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Chmura', 'Affiliation': 'University of Chicago Comprehensive Cancer Center, Chicago, Illinois.'}, {'ForeName': 'H Ian', 'Initials': 'HI', 'LastName': 'Robins', 'Affiliation': 'University of Wisconsin Hospital and Clinics, Madison, Wisconsin.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Connelly', 'Affiliation': 'Froedtert and the Medical College of Wisconsin, Milwaukee, Wisconsin.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Battiste', 'Affiliation': 'University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma.'}, {'ForeName': 'John L', 'Initials': 'JL', 'LastName': 'Villano', 'Affiliation': 'University of Kentucky, Lexington, Kentucky.'}, {'ForeName': 'Naveed', 'Initials': 'N', 'LastName': 'Wagle', 'Affiliation': 'University of Southern California, Los Angeles, California.'}, {'ForeName': 'Ryan T', 'Initials': 'RT', 'LastName': 'Merrell', 'Affiliation': 'North Shore University Health System, Evanston, Illinois.'}, {'ForeName': 'Merideth M', 'Initials': 'MM', 'LastName': 'Wendland', 'Affiliation': 'The US Oncology Network-Willamette Valley Cancer Institute, Eugene, Oregon.'}, {'ForeName': 'Minesh P', 'Initials': 'MP', 'LastName': 'Mehta', 'Affiliation': 'Baptist Hospital of Miami, Miami, Florida.'}]",Cancer,['10.1002/cncr.32811']
3641,31992861,Optical coherence tomography angiography for marginal corneal vascular remodelling after pterygium surgery with limbal-conjunctival autograft.,"PURPOSE


To demonstrate the marginal corneal vascular remodelling using optical coherence tomography angiography (OCTA) after pterygium surgery.
METHODS


Twenty-two eyes of 19 patients (8 males, 11 females; age, 58.68 ± 0.34 years) with primary grade-T3 nasal pterygium were enroled in this study. The eyes underwent excision of the pterygium followed by a free limbal-conjunctival autograft. OCTA was performed in the nasal limbal area before surgery and at 10 days, 1 month, and 3 months after surgery. The scans were analyzed in terms of postoperative vascular remodelling of the autograft and marginal corneal vascular arcades (MCAs).
RESULTS


Preoperatively, the pterygium presented as abnormal centripetal vascular growth in OCTA scans. The conjunctival vessel density in the nasal quadrant was 29.26% ± 1.00%, 15.80% ± 0.83%, 19.80% ± 0.88%, and 20.26% ± 0.89% before and 10 days, 1 month, and 3 months, respectively, after surgery (F = 1.55, P < 0.01). The vessel density of MCAs was 28.33% ± 0.88%, 42.09% ± 0.41%, and 42.46% ± 0.31% 10 days, 1 month, and 3 months, respectively, after surgery (F = 188.2, P < 0.01).
CONCLUSIONS


We describe a new application of OCTA for MCA vasculature imaging. Vascular remodelling of the graft and MCAs appeared at 1 month and continued for 3 months after surgery.",2020,"The conjunctival vessel density in the nasal quadrant was 29.26% ± 1.00%, 15.80% ± 0.83%, 19.80% ± 0.88%, and 20.26% ± 0.89% before and 10 days, 1 month, and 3 months, respectively, after surgery (F = 1.55, P ","['Twenty-two eyes of 19 patients (8 males, 11 females; age, 58.68\u2009±\u20090.34 years) with primary grade-T3 nasal pterygium', 'marginal corneal vascular remodelling after pterygium surgery with limbal-conjunctival autograft']","['excision of the pterygium followed by a free limbal-conjunctival autograft', 'optical coherence tomography angiography (OCTA', 'OCTA', 'Optical coherence tomography angiography']","['conjunctival vessel density', 'Vascular remodelling of the graft and MCAs', 'vessel density of MCAs']","[{'cui': 'C4284772', 'cui_str': '22 (qualifier value)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0033999', 'cui_str': 'Pterygium'}, {'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0443251', 'cui_str': 'Limbal (qualifier value)'}, {'cui': 'C0040736', 'cui_str': 'Autotransplantation'}]","[{'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0033999', 'cui_str': 'Pterygium'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0443251', 'cui_str': 'Limbal (qualifier value)'}, {'cui': 'C0040736', 'cui_str': 'Autotransplantation'}, {'cui': 'C0920367', 'cui_str': 'Tomography, Optical Coherence'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}]","[{'cui': 'C0148346', 'cui_str': 'Vessel'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C1527362', 'cui_str': 'grafts'}]",22.0,0.0678148,"The conjunctival vessel density in the nasal quadrant was 29.26% ± 1.00%, 15.80% ± 0.83%, 19.80% ± 0.88%, and 20.26% ± 0.89% before and 10 days, 1 month, and 3 months, respectively, after surgery (F = 1.55, P ","[{'ForeName': 'Zhanlin', 'Initials': 'Z', 'LastName': 'Zhao', 'Affiliation': ""Department of Ophthalmology, Ninth People's Hospital, Shanghai JiaoTong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Yue', 'Affiliation': ""Department of Ophthalmology, Ninth People's Hospital, Shanghai JiaoTong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Siyi', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': ""Department of Ophthalmology, Ninth People's Hospital, Shanghai JiaoTong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Jiaying', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ""Department of Ophthalmology, Ninth People's Hospital, Shanghai JiaoTong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Xiangyang', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Institute of Image Communication and Network Engineering, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Vittoria', 'Initials': 'V', 'LastName': 'Aragno', 'Affiliation': 'Department of Ophthalmology, Ambroise Paré Hospital, APHP, University of Paris Saclay, Paris, France.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Labbe', 'Affiliation': 'Department of Ophthalmology, Ambroise Paré Hospital, APHP, University of Paris Saclay, Paris, France.'}, {'ForeName': 'Xianqun', 'Initials': 'X', 'LastName': 'Fan', 'Affiliation': ""Department of Ophthalmology, Ninth People's Hospital, Shanghai JiaoTong University School of Medicine, Shanghai, China. fanxq@sjtu.edu.cn.""}, {'ForeName': 'Fu', 'Initials': 'F', 'LastName': 'Yao', 'Affiliation': ""Department of Ophthalmology, Ninth People's Hospital, Shanghai JiaoTong University School of Medicine, Shanghai, China. drfuyaofy@sina.com.""}]","Eye (London, England)",['10.1038/s41433-020-0773-8']
3642,32193070,Effects of a cultural competence education programme on clinical nurses: A randomised controlled trial.,"BACKGROUND


The cultural competence education programme for health professionals aimed to ensure that all people receive effective health care, particularly those from culturally diverse backgrounds.
OBJECTIVES


The purpose of this study was to investigate the effect of a cultural competence educational course on nurses' self-assessment of their cultural competence.
DESIGN


A single-blind, randomised control trial design was employed.
PARTICIPANTS AND SETTINGS


Eligible nurses were recruited from a northern Taiwan medical centre with 2089 beds.
METHODS


A permuted block of four was used to randomly assign participants to the experimental (n = 47) and control groups (n = 50). The educational course comprised four units and was conducted once weekly for four weeks, with each session lasting 3 h.
RESULTS


A significant group-time interaction was identified regarding self-learning cultural ability, verifying the education intervention's effect on self-learning cultural ability after a two-month intervention. In addition, a significant main effect over time was discovered for total cultural competence; there was no significant interaction effect.
CONCLUSIONS


The study provided evidence that an educational programme effectively improved cultural competence in clinical nurses. The results provide a reference for health care providers to design in-service cultural competence education for improving quality of care.",2020,"In addition, a significant main effect over time was discovered for total cultural competence; there was no significant interaction effect.
","['clinical nurses', 'Eligible nurses were recruited from a northern Taiwan medical centre with 2089 beds']","['cultural competence education programme', 'cultural competence educational course']","['cultural competence', 'quality of care', 'self-learning cultural ability']","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0039260', 'cui_str': 'Formosa'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0004916', 'cui_str': 'Beds'}]","[{'cui': 'C0679748', 'cui_str': 'Cultural Competence'}, {'cui': 'C0729314', 'cui_str': 'Education provision (procedure)'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}]","[{'cui': 'C0679748', 'cui_str': 'Cultural Competence'}, {'cui': 'C0034379', 'cui_str': 'Quality of Care'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",,0.0841667,"In addition, a significant main effect over time was discovered for total cultural competence; there was no significant interaction effect.
","[{'ForeName': 'Mei-Hsiang', 'Initials': 'MH', 'LastName': 'Lin', 'Affiliation': 'School of Nursing, National Taipei University of Nursing and Health Sciences, Taiwan, R.O.C.'}, {'ForeName': 'Hsiu-Chin', 'Initials': 'HC', 'LastName': 'Hsu', 'Affiliation': 'Graduate Institute of Gerontology and Health Care Management, Chang Gung University of Science and Technology, Taiwan, R.O.C.. Electronic address: hchsu@mail.cgust.edu.tw.'}]",Nurse education today,['10.1016/j.nedt.2020.104385']
3643,31762434,A cluster-randomized crossover trial of Montessori activities delivered by family carers to nursing home residents with behavioral and psychological symptoms of dementia.,"OBJECTIVES


One-on-one structured Montessori-based activities conducted with people with dementia can improve agitation and enhance engagement. These activities may however not always be implemented by nursing home staff. Family members may present an untapped resource for enabling these activities. This study aimed to evaluate the impact of the Montessori activities implemented by family members on visitation experiences with people who have dementia.
DESIGN


Cluster-randomized crossover design.
SETTING


General and psychogeriatric nursing homes in the state of Victoria, Australia.
PARTICIPANTS


Forty participants (20 residents and 20 carers) were recruited.
INTERVENTION


During visits, family members interacted with their relative either through engaging in Montessori-based activities or reading a newspaper (the control condition) for four 30-minute sessions over 2 weeks.
MEASUREMENTS


Residents' predominant affect and engagement were rated for each 30-second interval using the Philadelphia Geriatric Center Affect Rating Scale and the Menorah Park Engagement Scale. The Pearlin Mastery Scale was used to rate carers satisfaction with visits. The 15-item Mutuality Scale measured the carers quality of their relationship with the resident. Carers' mood and overall quality of life were measured using the Center for Epidemiological Studies Depression Scale and Carer-QoL questionnaires, respectively.
RESULTS


Linear regressions within the generalized estimating equations approach assessed residents' and carers' outcomes. Relative to the control condition, the Montessori condition resulted in more positive engagement (b = 13.0, 95%CI 6.3-19.7, p < 0.001) and affect (b = 0.4, 95%CI 0.2-0.6, p < 0.001) for the residents and higher satisfaction with visits for carers (b = 1.7, 95%CI 0.45-3.00, p = 0.008). No correction was applied to p-values for multiple comparisons.
CONCLUSION


This study strengthens the evidence base for the use of the Montessori programs in increasing well-being in nursing home residents. The findings also provide evidence that family members are an additional valuable resource in implementing structured activities such as the Montessori program with residents.",2020,This study strengthens the evidence base for the use of the Montessori programs in increasing well-being in nursing home residents.,"['General and psychogeriatric nursing homes in the state of Victoria, Australia', 'family members on visitation experiences with people who have dementia', 'Forty participants (20 residents and 20 carers) were recruited', 'family carers to nursing home residents with behavioral and psychological symptoms of dementia']",['Montessori activities'],"['Philadelphia Geriatric Center Affect Rating Scale and the Menorah Park Engagement Scale', '15-item Mutuality Scale', 'Epidemiological Studies Depression Scale and Carer-QoL questionnaires', 'positive engagement', 'Pearlin Mastery Scale', ""Carers' mood and overall quality of life""]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0017467', 'cui_str': 'Psychogeriatrics'}, {'cui': 'C0028688', 'cui_str': 'Nursing Homes'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0042645', 'cui_str': 'Victoria'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C1305660', 'cui_str': 'Carer (occupation)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C4285807', 'cui_str': 'Neuropsychiatric symptoms'}]","[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]","[{'cui': 'C0031525', 'cui_str': 'Philadelphia'}, {'cui': 'C0017469', 'cui_str': 'Geriatrics'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0562547', 'cui_str': 'Park (environment)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C1305660', 'cui_str': 'Carer (occupation)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0034380'}]",40.0,0.0437061,This study strengthens the evidence base for the use of the Montessori programs in increasing well-being in nursing home residents.,"[{'ForeName': 'Lingani', 'Initials': 'L', 'LastName': 'Mbakile-Mahlanza', 'Affiliation': 'Department of Psychology, Faculty of Social Sciences, University of Botswana, Gaborone, Botswana.'}, {'ForeName': 'Eva S', 'Initials': 'ES', 'LastName': 'van der Ploeg', 'Affiliation': 'Aged Mental Health Research Unit, School of Psychology and Psychiatry, Monash University, Melbourne, Australia.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Busija', 'Affiliation': 'School of Public Health and Preventative Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Cameron', 'Initials': 'C', 'LastName': 'Camp', 'Affiliation': 'Center for Applied Research in Dementia, Solon, OH, USA.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Walker', 'Affiliation': 'Deakin University, Melbourne, Australia.'}, {'ForeName': 'Daniel W', 'Initials': 'DW', 'LastName': ""O'Connor"", 'Affiliation': 'Department of Psychiatry, Monash University, Clayton, Victoria, Australia.'}]",International psychogeriatrics,['10.1017/S1041610219001819']
3644,32173766,Exercise intensity prescription in cancer survivors: ventilatory and lactate thresholds are useful submaximal alternatives to VO 2peak .,"PURPOSE


Most studies with cancer survivors use percentages of peak oxygen uptake (VO 2peak ) for intensity prescription. Lactate or ventilatory thresholds might be useful submaximal alternatives, but this has never been investigated. Therefore, we aimed at comparing three training sessions prescribed using %VO 2peak  (reference), lactate thresholds, and ventilatory thresholds in terms of meeting the vigorous-intensity zone, physiological, and psychological responses.
METHODS


Twenty breast (58 ± 10 years) and 20 prostate cancer survivors (68 ± 6 years), 3.6 ± 2.4 months after primary therapy, completed a maximal cardiopulmonary exercise test and three vigorous training sessions in randomized order: 38 min of cycling at 70% VO 2peak  (M-VO 2peak ), 97% of individual anaerobic lactate threshold (M-IAT), and 67% between ventilatory thresholds 1 and 2 (M-VT). Heart rate (HR), blood lactate concentration (bLa), perceived exertion, and enjoyment were assessed.
RESULTS


Cancer survivors exercised at 75 ± 23, 85 ± 18, and 79 ± 19 W during M-VO 2peak , M-IAT, and M-VT (p > .05). Sessions could not be completed in 3, 8, and 6 cases. Session completers showed HR of 82 ± 7, 83 ± 9, and 84 ± 8 %HR peak  and bLa of 3.7 ± 1.9, 3.9 ± 0.9, and 3.9 ± 1.5 mmol·l -1 , which was not different between sessions (p > .05). However, variance in bLa was lower in M-IAT compared to M-VO 2peak  (p = .001) and to M-VT (p = .022).
CONCLUSION


All intensity prescription methods on average met the targeted intensity zone. Metabolic response was most homogeneous when using lactate thresholds.
IMPLICATIONS FOR CANCER SURVIVORS


Submaximal thresholds are at least as useful as VO 2peak  for intensity prescription in cancer survivors. Overall, slightly lower percentages should be chosen to improve durability of the training sessions.",2020,"However, variance in bLa was lower in M-IAT compared to M-VO 2peak  (p = .001) and to M-VT (p = .022).
","['cancer survivors', 'FOR CANCER SURVIVORS', 'Twenty breast (58\u2009±\u200910\xa0years) and 20 prostate cancer survivors (68\u2009±\u20096\xa0years), 3.6\u2009±\u20092.4\xa0months after primary therapy, completed a']","['Exercise intensity prescription', 'maximal cardiopulmonary exercise test and three vigorous training sessions']","['Metabolic response', 'Heart rate (HR), blood lactate concentration (bLa), perceived exertion, and enjoyment', 'variance in bLa', 'peak oxygen uptake (VO 2peak ']","[{'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C4517694', 'cui_str': '3.6 (qualifier value)'}, {'cui': 'C4517631', 'cui_str': '2.4 (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C2959886', 'cui_str': 'Cardiopulmonary Exercise Test'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0005768'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake (observable entity)'}]",,0.0364949,"However, variance in bLa was lower in M-IAT compared to M-VO 2peak  (p = .001) and to M-VT (p = .022).
","[{'ForeName': 'Justine', 'Initials': 'J', 'LastName': 'Schneider', 'Affiliation': 'Working Group Exercise Oncology, Department of Medical Oncology, National Center for Tumor Diseases (NCT), Heidelberg University Hospital, Im Neuenheimer Feld 460, 69120, Heidelberg, Germany.'}, {'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Schlüter', 'Affiliation': 'Working Group Exercise Oncology, Department of Medical Oncology, National Center for Tumor Diseases (NCT), Heidelberg University Hospital, Im Neuenheimer Feld 460, 69120, Heidelberg, Germany.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Sprave', 'Affiliation': 'Department of Radiation Oncology, University Hospital Heidelberg and National Center for Radiation Oncology (NCRO), Heidelberg Institute for Radiation Oncology (HIRO), Heidelberg, Germany.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Wiskemann', 'Affiliation': 'Working Group Exercise Oncology, Department of Medical Oncology, National Center for Tumor Diseases (NCT), Heidelberg University Hospital, Im Neuenheimer Feld 460, 69120, Heidelberg, Germany.'}, {'ForeName': 'Friederike', 'Initials': 'F', 'LastName': 'Rosenberger', 'Affiliation': 'Working Group Exercise Oncology, Department of Medical Oncology, National Center for Tumor Diseases (NCT), Heidelberg University Hospital, Im Neuenheimer Feld 460, 69120, Heidelberg, Germany. friederike.rosenberger@nct-heidelberg.de.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-020-05407-y']
3645,32163564,The effect of type of oral contraceptive pill and duration of use on fresh and cumulative live birth rates in IVF/ICSI cycles.,"STUDY QUESTION


Are there any differences in the fresh (LB) and cumulative live birth rates (CLBR) of women undergoing controlled ovarian stimulation (COS) for IVF/ICSI following pretreatment with different types of oral contraceptive pills (OCP) for different durations as compared to no-OCP?
SUMMARY ANSWER


OCP administration for an interval of 12- to 30-day treatment period and with a 5-day washout period does not affect clinical pregnancy, LB nor cumulative LB in patients undergoing COS for an IVF cycle.
WHAT IS KNOWN ALREADY


The use of OCP is an effective way of treatment planning in IVF/ICSI cycles, but published evidence about its effect on pregnancy and LBR is inconsistent, some studies finding decreased rates but others no difference.
STUDY DESIGN, SIZE, DURATION


This is a retrospective analysis carried out in a University-affiliated tertiary centre between January 2009 and December 2017. Overall, 4116 infertile women between 18 and 45 years, who underwent their first ovarian stimulation cycle in our centre, were included.
PARTICIPANTS/MATERIALS, SETTING, METHODS


Patients were categorised into two groups as receiving OCP (n = 3517) or not (no OCP, n = 599). All patients with OCP pretreatment initiated controlled ovarian stimulation (COS) 5 days post-pill. Overall, two types of OCP were used at the study's centre: ethinylestradiol (EE) 30 μg/desogestrel 150 μg, a third-generation progesterone; or EE 30 μg/drospirenone 3 mg, a fourth-generation progestin with mild antiandrogenic activity.
MAIN RESULTS AND THE ROLE OF CHANCE


A total of n = 4116 patients were analysed, (OCP n = 3517 and non-OCP n = 599). The use of OCP was independently associated with a small increase in the number of oocytes retrieved after adjusting for age, BMI, use of OCP, cause of infertility, initial dose (IU), type of gonadotropin, stimulation days, total stimulation units (total IU) (β 0.22, 95% CI 0.12-0.31). Cumulative LBRs were comparable between groups OCP versus non-OCP (32.4 versus 31.6%, P = 0.712). Following adjustment for age, BMI, infertility diagnosis, starting and total dose, type of gonadotropin, total days of stimulation, type of insemination, number of oocytes retrieved, day of transfer and number of embryos transferred in a multiple logistic analysis, patients using OCPs had a similar probability of achieving a LB as compared with patients not-using OCPs following fresh embryo transfer (ORadj 0.89, 95% CI 0.69-1.15) and a similar probability for CLBR after the use of fresh and frozen embryos (ORadj 0.94, 95% CI 0.73-1.21). No differences were observed in ovarian stimulation and clinical outcomes between drospirenone and desogestrel OCP groups.
LIMITATIONS, REASONS FOR CAUTION


Limitations are related to the retrospective nature of the study; despite the sample size, the adjustments and the multivariable regression analysis conducted, we cannot exclude the presence of confounding bias. OCP administration was not randomly assigned, not allowing to exclude the presence of selection bias. Lastly, we only used two types of OCP with durations and washout periods as per institution protocol. Therefore, we cannot exclude that longer duration of administration, a different type of OCP or different pill-free interval might have had an alternative effect on LBR or CLBR; thus, the generalizability of this study's results should be considered with caution.
WIDER IMPLICATIONS OF THE FINDINGS


Our study provides reassuring evidence that the use of 12-30 days OCP for cycle programming, prior to IVF, does not decrease the chance of live birth and cumulative live birth rates.
STUDY FUNDING/COMPETING INTEREST(S)


No external funding was used for this study. This research was performed under the auspices of 'Càtedra d'Investigació en Obstetrícia I Ginecologia' of the Department of Obstetrics, Gynaecology and Reproductive Medicine, Hospital Universitario Dexeus, Universitat Autònoma de Barcelona. The authors report no conflict of interest associated with the current study.
TRIAL REGISTRATION NUMBER


NA.",2020,"No differences were observed in ovarian stimulation and clinical outcomes between drospirenone and desogestrel OCP groups.
","['4116 patients were analysed, (OCP n\xa0=\u20093517 and non-OCP n\xa0=\u2009599', '4116 infertile women between 18 and 45\xa0years, who underwent their first ovarian stimulation cycle in our centre, were included', 'Patients were categorised into two groups as receiving OCP (n\xa0=\u20093517) or not (no OCP, n\xa0=\u2009599', 'University-affiliated tertiary centre between January 2009 and December 2017', 'A total of n\xa0']","['oral contraceptive pills (OCP', 'OCP pretreatment initiated controlled ovarian stimulation (COS', 'OCP', 'ethinylestradiol (EE) 30\xa0μg/desogestrel 150\xa0μg, a third-generation progesterone; or EE 30\xa0μg', 'oral contraceptive pill', 'drospirenone']","['clinical pregnancy, LB nor cumulative LB', 'BMI, infertility diagnosis, starting and total dose, type of gonadotropin, total days of stimulation, type of insemination, number of oocytes retrieved, day of transfer and number of embryos transferred', 'Cumulative LBRs', 'chance of live birth and cumulative live birth rates', 'fresh (LB) and cumulative live birth rates (CLBR', 'number of oocytes', 'ovarian stimulation and clinical outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021359', 'cui_str': 'Infertility'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0949385', 'cui_str': 'Ovarian Stimulation'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]","[{'cui': 'C0029151', 'cui_str': 'Oral contraception (finding)'}, {'cui': 'C0994475', 'cui_str': 'Pill (basic dose form)'}, {'cui': 'C3160898', 'cui_str': 'Controlled ovarian stimulation'}, {'cui': 'C0454802', 'cui_str': 'Cos (geographic location)'}, {'cui': 'C0015011', 'cui_str': 'Ethinyl Estradiol'}, {'cui': 'C0057558', 'cui_str': 'Desogestrel'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0373705', 'cui_str': 'Progesterone measurement (procedure)'}, {'cui': 'C0043822', 'cui_str': 'drospirenone'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0021359', 'cui_str': 'Infertility'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C4543260', 'cui_str': 'Gonadotropin'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0021586', 'cui_str': 'Insemination'}, {'cui': 'C0449803', 'cui_str': 'Number of oocytes (qualifier value)'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0449951', 'cui_str': 'Number of embryos transferred (qualifier value)'}, {'cui': 'C0481667', 'cui_str': 'Live Birth'}, {'cui': 'C0443224', 'cui_str': 'Fresh (qualifier value)'}, {'cui': 'C0949385', 'cui_str': 'Ovarian Stimulation'}]",4116.0,0.135241,"No differences were observed in ovarian stimulation and clinical outcomes between drospirenone and desogestrel OCP groups.
","[{'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Montoya-Botero', 'Affiliation': 'Department of Reproductive Medicine, Dexeus University Hospital, Gran Via de Carles III, 71-75, Barcelona 08022, Spain.'}, {'ForeName': 'Francisca', 'Initials': 'F', 'LastName': 'Martinez', 'Affiliation': 'Department of Reproductive Medicine, Dexeus University Hospital, Gran Via de Carles III, 71-75, Barcelona 08022, Spain.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Rodríguez-Purata', 'Affiliation': 'Department of Reproductive Medicine, Dexeus University Hospital, Gran Via de Carles III, 71-75, Barcelona 08022, Spain.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Rodríguez', 'Affiliation': 'Department of Reproductive Medicine, Dexeus University Hospital, Gran Via de Carles III, 71-75, Barcelona 08022, Spain.'}, {'ForeName': 'Buenaventura', 'Initials': 'B', 'LastName': 'Coroleu', 'Affiliation': 'Department of Reproductive Medicine, Dexeus University Hospital, Gran Via de Carles III, 71-75, Barcelona 08022, Spain.'}, {'ForeName': 'Nikolaos P', 'Initials': 'NP', 'LastName': 'Polyzos', 'Affiliation': 'Department of Reproductive Medicine, Dexeus University Hospital, Gran Via de Carles III, 71-75, Barcelona 08022, Spain.'}]","Human reproduction (Oxford, England)",['10.1093/humrep/dez299']
3646,31986899,Development and Evaluation of a Cancer Literacy Intervention to Promote Mammography Screening Among Navajo Women: A Pilot Study.,"PURPOSE


Develop and evaluate a mammography intervention that provides hope about cancer prevention and treatment.
DESIGN


Pilot randomized controlled trial.
SETTING


Two communities on the Navajo Nation.
PARTICIPANTS


Navajo women and support persons.
INTERVENTION


Both groups received standard care: one home visit discussing mammography pros/cons and barriers. The treatment group received an intervention based on Navajo language via an additional home visit with health education materials (written and oral) in English and Navajo, including a Navajo Cancer Glossary with a new descriptive phrase for cancer.
ANALYSIS


Between control and intervention conditions, we compared baseline sociodemographics; changes from baseline to 3 months on mammography completion and breast cancer literacy scores.
MEASURES


(1) intervention feasibility; (2) self- and clinic-reported mammography screening completion; (3) breast cancer literacy.
RESULTS


A total of 25 participants were randomly assigned (13 treatment, 12 control), with 7 support persons in each arm. Mean age was 53 years, 90% had a high school degree or higher, 86% spoke Navajo and English. At 3 months, 44% had a clinically verified mammogram. Mammography completion was 57% among those with a support person and 27% among those without ( P  = .14). Intervention women reported more breast cancer beliefs consistent with mammography ( P  = .015).
CONCLUSIONS


Increases in breast cancer beliefs consistent with mammography show promise. Findings highlight a need to tailor education materials to Navajo culture/language and focus on enhancing support.",2020,Mammography completion was 57% among those with a support person and 27% among those without ( P  = .14).,"['Two communities on the Navajo Nation', 'A total of 25 participants', 'Mean age was 53 years, 90% had a high school degree or higher, 86% spoke Navajo and English', 'Navajo Women', 'Navajo women and support persons']","['standard care: one home visit discussing mammography pros/cons and barriers', 'intervention based on Navajo language via an additional home visit with health education materials (written and oral) in English and Navajo, including a Navajo Cancer Glossary with a new descriptive phrase for cancer', 'Cancer Literacy Intervention', 'mammography intervention']","['1) intervention feasibility; (2) self- and clinic-reported mammography screening completion; (3) breast cancer literacy', 'Mammography completion', 'mammography completion and breast cancer literacy scores', 'breast cancer beliefs']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0027361', 'cui_str': 'Persons'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0020043', 'cui_str': 'Home Visits'}, {'cui': 'C0024671', 'cui_str': 'Mammography'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0574545', 'cui_str': 'Navajo language (qualifier value)'}, {'cui': 'C0018701'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0681470', 'cui_str': 'Glossary'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0600665', 'cui_str': 'Phrase'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0024671', 'cui_str': 'Mammography'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}]",25.0,0.040073,Mammography completion was 57% among those with a support person and 27% among those without ( P  = .14).,"[{'ForeName': 'Pamela S', 'Initials': 'PS', 'LastName': 'Sinicrope', 'Affiliation': 'Department of Psychiatry and Psychology and Behavioral Health Research Program, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Mark C', 'Initials': 'MC', 'LastName': 'Bauer', 'Affiliation': 'Diné College, Tsaile, AZ, USA.'}, {'ForeName': 'Christi A', 'Initials': 'CA', 'LastName': 'Patten', 'Affiliation': 'Department of Psychiatry and Psychology and Behavioral Health Research Program, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Austin-Garrison', 'Affiliation': 'Diné College, Tsaile, AZ, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Garcia', 'Affiliation': 'Diné College, Tsaile, AZ, USA.'}, {'ForeName': 'Christine A', 'Initials': 'CA', 'LastName': 'Hughes', 'Affiliation': 'Department of Psychiatry and Psychology and Behavioral Health Research Program, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Martha J', 'Initials': 'MJ', 'LastName': 'Bock', 'Affiliation': 'Department of Psychiatry and Psychology and Behavioral Health Research Program, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Decker', 'Affiliation': 'Department of Health Sciences Research, Biomedical Statistics and Behavioral Health Research Program, Rochester, MN, USA.'}, {'ForeName': 'Kathleen J', 'Initials': 'KJ', 'LastName': 'Yost', 'Affiliation': 'Department of Health Sciences Research, Survey Research Center, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Wesley O', 'Initials': 'WO', 'LastName': 'Petersen', 'Affiliation': 'Department of Psychiatry and Psychology and Behavioral Health Research Program, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Lydia P', 'Initials': 'LP', 'LastName': 'Buki', 'Affiliation': 'Department of Educational and Psychological Studies, University of Miami, Coral Gables, FL, USA.'}, {'ForeName': 'Edward R', 'Initials': 'ER', 'LastName': 'Garrison', 'Affiliation': 'Diné College, Tsaile, AZ, USA.'}]",American journal of health promotion : AJHP,['10.1177/0890117119900592']
3647,31846824,Regional changes in indices of bone strength of upper and lower limbs in response to high-intensity impact loading or high-intensity resistance training.,"It is well known that the bone response to physical activity is highly dependent on the nature of the loads imposed. Despite this, few direct comparisons of the effect of impact-style loading and resistance training on bone have been made. We therefore aimed to compare the effects of 10-month, twice-weekly, high-impact loading and 10-month, twice-weekly, high-intensity resistance training on indices of bone strength of both the upper and lower limbs of young adult women. Physically inactive, otherwise healthy, young adult women (18-30 years) with below average bone mass (T-score ≤ 0) were recruited as part of the OPTIMA-Ex trial. Testing included DXA- and pQCT-derived measures of bone mass and indices of bone strength and QUS-derived measures of bone quality of the dominant (D) and non-dominant (ND) upper (radius) and lower limbs (femoral neck, tibia, calcaneus). The present study examined those participants who completed the impact training (IT; n = 10) and resistance training (RT; n = 12) arms of the trial. Age differed between groups at baseline (IT = 23.2 ± 3.8 years, RT = 20.5 ± 1.8 years; p = 0.042). Compliance with the training programs did not differ (IT = 61.4 ± 15.1%, RT = 66.4 ± 11.2%, p = 0.381). Age and baseline differences in bone outcomes served as covariates for repeated measures and univariate ANCOVA conducted for dependent variables and percent change respectively. IT improved distal pQCT-derived bone mineral density (BMD) of the upper limb (ND radius: total BMD = 8.55 ± 2.26% versus 1.50 ± 2.04%, p = 0.040 and trabecular BMD = 1.86 ± 0.90% versus -1.30 ± 0.81%, p = 0.029) and lower limb (ND tibia trabecular BMD = 1.22 ± 0.55% versus -0.82 ± 0.50%, p = 0.017), more than RT. IT also improved upper limb bone strength index (BSI) (ND radius total BSI = 15.35 ± 2.83% versus 2.67 ± 2.55, p = 0.005) and lower limb BSI (D tibia total BSI = 5.16 ± 1.13% versus 0.37 ± 1.02%, p = 0.008; D tibia trabecular BSI = 3.93 ± 1.76% versus -2.84 ± 1.59, p = 0.014, ND tibia trabecular BSI = 3.57 ± 1.63% versus -3.15 ± 1.48%, p = 0.009) more than RT. Conversely, RT improved DXA-derived cortical volumetric BMD at the femoral neck more than IT (3.68 ± 1.99% versus -4.14 ± 2.20%, p = 0.021). Results suggest that IT and RT provide differing site-specific effects in both the upper and lower limbs, with superior bone responses observed at the distal segment from IT, while RT appeared to have greater effect on the shaft of the bone, on indices of bone-strength in young adult women.",2020,"Compliance with the training programs did not differ (IT = 61.4 ± 15.1%, RT = 66.4 ± 11.2%, p = 0.381).","['participants who completed the impact training (IT; n\u202f=\u202f10) and resistance training (RT; n\u202f=\u202f12) arms of the trial', 'Physically inactive, otherwise healthy, young adult women (18-30\u202fyears) with below average bone mass (T-score\u202f≤\u202f0) were recruited as part of the OPTIMA-Ex trial', 'young adult women']","['high-impact loading and 10-month, twice-weekly, high-intensity resistance training']","['DXA- and pQCT-derived measures of bone mass and indices of bone strength and QUS-derived measures of bone quality of the dominant (D) and non-dominant (ND) upper (radius) and lower limbs (femoral neck, tibia, calcaneus', 'RT improved DXA-derived cortical volumetric BMD', 'upper limb bone strength index (BSI', 'lower limb BSI', 'bone-strength', 'distal pQCT-derived bone mineral density (BMD']","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0556985', 'cui_str': 'Two times a week'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0015815', 'cui_str': 'Femoral Neck'}, {'cui': 'C0040184', 'cui_str': 'Tibia'}, {'cui': 'C0006655', 'cui_str': 'Heel Bone'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0445383', 'cui_str': 'Volumetric (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}]",,0.0204077,"Compliance with the training programs did not differ (IT = 61.4 ± 15.1%, RT = 66.4 ± 11.2%, p = 0.381).","[{'ForeName': 'Conor', 'Initials': 'C', 'LastName': 'Lambert', 'Affiliation': 'Menzies Health Institute Queensland, Griffith University, Gold Coast, Queensland, Australia; School of Allied Health Sciences, Griffith University, Gold Coast, Queensland, Australia.'}, {'ForeName': 'Belinda R', 'Initials': 'BR', 'LastName': 'Beck', 'Affiliation': 'Menzies Health Institute Queensland, Griffith University, Gold Coast, Queensland, Australia; School of Allied Health Sciences, Griffith University, Gold Coast, Queensland, Australia; The Bone Clinic, Brisbane, Queensland, Australia.'}, {'ForeName': 'Amy T', 'Initials': 'AT', 'LastName': 'Harding', 'Affiliation': 'Menzies Health Institute Queensland, Griffith University, Gold Coast, Queensland, Australia; School of Allied Health Sciences, Griffith University, Gold Coast, Queensland, Australia.'}, {'ForeName': 'Steven L', 'Initials': 'SL', 'LastName': 'Watson', 'Affiliation': 'Menzies Health Institute Queensland, Griffith University, Gold Coast, Queensland, Australia; School of Allied Health Sciences, Griffith University, Gold Coast, Queensland, Australia.'}, {'ForeName': 'Benjamin K', 'Initials': 'BK', 'LastName': 'Weeks', 'Affiliation': 'Menzies Health Institute Queensland, Griffith University, Gold Coast, Queensland, Australia; School of Allied Health Sciences, Griffith University, Gold Coast, Queensland, Australia. Electronic address: b.weeks@griffith.edu.au.'}]",Bone,['10.1016/j.bone.2019.115192']
3648,32170194,"Comparison of the effectiveness of female voice, male voice, and hybrid voice-tone smoke alarms for sleeping children.","BACKGROUND


To test whether children awaken from slow wave sleep and perform an escape procedure better in response to a smoke alarm that uses a male voice, female voice, combination of a low-frequency tone plus a female voice (hybrid alarm), or high-frequency tone.
METHODS


Using a randomized, non-blinded, repeated-measures design, 188 children aged 5-12 years were exposed during stage 4 slow wave sleep to four smoke alarms.
RESULTS


Among study subjects, 84.6%, 87.2%, 88.8%, and 56.4% awakened and 84.0%, 86.7%, 88.8%, and 55.3% successfully performed the escape procedure within 5 min of alarm onset in response to the male voice, female voice, hybrid, and high-frequency tone alarms, respectively, while the median time-to-escape was 12.0, 12.0, 13.0, and 96.5 s for these four alarms, respectively. All pairwise comparisons between the high-frequency tone alarm and each of the other three alarms were statistically significant for the proportions of subjects who awakened or escaped and for time-to-awaken and time-to-escape. There were no significant differences in these outcome measures between the latter three alarms.
CONCLUSIONS


Use of the male or female voice or hybrid alarms in children's sleep areas may reduce residential fire-related injuries and deaths among children old enough to perform self-rescue.
IMPACT


The male voice, female voice, and hybrid alarms were each significantly more effective than a high-frequency tone alarm in awakening children aged 5-12 years from slow wave sleep and prompting their performance of an escape procedure. There were no significant differences in the effectiveness of the male voice, female voice, and hybrid alarms when compared with each other. Use of these alarms in children's sleep areas may reduce residential fire-related injuries and deaths among children old enough to perform self-rescue.",2020,"There were no significant differences in the effectiveness of the male voice, female voice, and hybrid alarms when compared with each other.","[""children's sleep areas"", 'sleeping children', '188 children aged 5-12 years were exposed during stage 4 slow wave sleep to four smoke alarms']","['female voice, male voice, and hybrid voice-tone smoke alarms']","['median time-to-escape', 'effectiveness of the male voice, female voice, and hybrid alarms']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4 (qualifier value)'}, {'cui': 'C0234451', 'cui_str': 'Sleep, Slow-Wave'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0336648', 'cui_str': 'Alarm, device (physical object)'}]","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0020205', 'cui_str': 'Hybrids'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0336648', 'cui_str': 'Alarm, device (physical object)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0020205', 'cui_str': 'Hybrids'}, {'cui': 'C0336648', 'cui_str': 'Alarm, device (physical object)'}]",188.0,0.0473454,"There were no significant differences in the effectiveness of the male voice, female voice, and hybrid alarms when compared with each other.","[{'ForeName': 'Gary A', 'Initials': 'GA', 'LastName': 'Smith', 'Affiliation': ""Center for Injury Research and Policy, The Research Institute at Nationwide Children's Hospital, Columbus, OH, USA. gary.smith@nationwidechildrens.org.""}, {'ForeName': 'Thitphalak', 'Initials': 'T', 'LastName': 'Chounthirath', 'Affiliation': ""Center for Injury Research and Policy, The Research Institute at Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Splaingard', 'Affiliation': 'Department of Pediatrics, The Ohio State University College of Medicine, Columbus, OH, USA.'}]",Pediatric research,['10.1038/s41390-020-0838-1']
3649,32169003,Randomized controlled trial of a sibling support group: Mental health outcomes for siblings of children with autism.,"LAY ABSTRACT


Typically developing siblings of a child with autism spectrum disorder may show mental health difficulties. A support group is one approach to help typically developing siblings. During support groups, typically developing siblings discuss their feelings, learn coping strategies and problem-solving skills, and develop a peer network. We compared a support group to participation in a similar group without a focus on the sibling with autism spectrum disorder. Some areas of mental health improved. Improvements were also impacted by autism spectrum disorder symptom severity in the sibling with autism spectrum disorder. Findings suggest continuing to examine how support groups can help typically developing siblings and for which siblings support groups might be particularly effective.",2020,Findings suggest continuing to examine how support groups can help typically developing siblings and for which siblings support groups might be particularly effective.,['siblings of children with autism'],['sibling support group: Mental health outcomes'],['autism spectrum disorder symptom severity'],"[{'cui': 'C0037047', 'cui_str': 'Sibling'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}]","[{'cui': 'C0150345', 'cui_str': 'Sibling support (regime/therapy)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]","[{'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}]",,0.0316823,Findings suggest continuing to examine how support groups can help typically developing siblings and for which siblings support groups might be particularly effective.,"[{'ForeName': 'Emily A', 'Initials': 'EA', 'LastName': 'Jones', 'Affiliation': 'The City University of New York, USA.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Fiani', 'Affiliation': 'The City University of New York, USA.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Stewart', 'Affiliation': 'Laureate Institute for Brain Research, USA.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Neil', 'Affiliation': 'Western University, Canada.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'McHugh', 'Affiliation': 'The City University of New York, USA.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Fienup', 'Affiliation': 'The City University of New York, USA.'}]",Autism : the international journal of research and practice,['10.1177/1362361320908979']
3650,32112909,Re- and demineralization characteristics of dentin depending on fluoride application and baseline characteristics in situ.,"OBJECTIVES


The aim of this double-blinded, randomized, cross-over in situ study was to evaluate the re- and demineralization characteristics of sound dentin as well as highly and lowly demineralized dentin after the application of different fluoride concentrations.
METHODS


In each of four experimental legs of four weeks 20 participants wore intraoral mandibular appliances containing two (highly demineralized [E H ]) bovine enamel and four (lowly and highly demineralized [D L ,D H ]) bovine dentin specimens (n = 480). Each specimen included one sound (ST) and one demineralized lesion area (DT). The four randomly allocated treatments included the following dentifrices: fluoride-free, zinc-carbonate-nano-hydroxyapatite [nHA 0 ], 0 ppm F -  [negative control,NaF 0 ], 1100 ppm F -  as NaF [standard therapy,NaF 1100 ] and 5000 ppm F -  as NaF [positive control,NaF 5000 ]. Differences in integrated mineral loss (ΔΔZ) and lesion depth (ΔLD) were calculated between values before and after the in situ period using transversal microradiography.
RESULTS


After the in situ period specimens of nHA 0  and NaF 0  showed signs of demineralization, indicated by significantly lower ΔZ&LD values for E H  and D L  (only nHA 0 )(p ≤ 0.028), whereas specimens of NaF 1100  and NaF 5000  showed signs of remineralization, indicated by significantly higher ΔZ values for E H  (only NaF 5000 ), D L  and D H  (p ≤ 0.012). The correlation between ΔΔZ DT /ΔΔZ ST  and F -  was moderate for E H (r DT  = 0.497;r ST  = 0.463) and D L (r DT  = 0.575;r ST  = 0.598) and strong for D H (r DH  = 0.700;r ST  = 0.611)(p < 0.001). No significant differences for ΔΔZ DT /ΔΔZ ST  were observed between nHA 0  and NaF 0 (p ≥ 0.333;ANCOVA).
CONCLUSION


The present in situ model was capable to reveal a fluoride dose-response on sound, lowly and highly demineralized dentin and also enamel specimens. Furthermore, both fluoride-free dentifrices, one containing nanohydroxyapatite, did not hamper demineralization.
CLINICAL SIGNIFICANCE


The present in situ model was capable to reveal a fluoride dose-response on dentin similar to the anticipated clinical efficacy. Highly demineralized specimens seem to be recommendable for measuring anti-caries effects on dentin in situ. Furthermore both fluoride-free dentifrices, one containing nanohydroxyapatite, did not hamper demineralization. The study was registered in the German Clinical Trials Register (DRKS-ID: DRKS00011653).",2020,"Furthermore both fluoride-free dentifrices, one containing nanohydroxyapatite, did not hamper demineralization.",[],"['dentifrices: fluoride-free, zinc-carbonate-nano-hydroxyapatite [nHA 0 ], 0\u2009ppm F- [negative control,NaF 0 ], 1100\u2009ppm F- as NaF [standard therapy,NaF 1100 ] and 5000\u2009ppm', 'intraoral mandibular appliances containing two (highly demineralized [E H ]) bovine enamel and four (lowly and highly demineralized [D L ,D H ]) bovine dentin specimens']","['signs of demineralization', 'integrated mineral loss (ΔΔZ) and lesion depth (ΔLD', 'ΔZ&LD values for E H  and D L', 'signs of remineralization']",[],"[{'cui': 'C0040462', 'cui_str': 'Toothpaste'}, {'cui': 'C0016327', 'cui_str': 'Fluorides'}, {'cui': 'C0078772', 'cui_str': 'zinc carbonate'}, {'cui': 'C0115137', 'cui_str': 'Durapatite'}, {'cui': 'C0439187', 'cui_str': 'parts per million'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4517537', 'cui_str': 'One thousand one hundred'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4319610', 'cui_str': '5000 (qualifier value)'}, {'cui': 'C0442119', 'cui_str': 'Intraoral approach (qualifier value)'}, {'cui': 'C0243112'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C1265545', 'cui_str': 'Family Bovidae'}, {'cui': 'C0011350', 'cui_str': 'Enamel'}, {'cui': 'C0231971', 'cui_str': 'Diffusion capacity of lung'}, {'cui': 'C0011429', 'cui_str': 'Dentin'}]","[{'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0700185', 'cui_str': 'Demineralized structure'}, {'cui': 'C0026162', 'cui_str': 'Minerals'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0231971', 'cui_str': 'Diffusion capacity of lung'}]",,0.0620591,"Furthermore both fluoride-free dentifrices, one containing nanohydroxyapatite, did not hamper demineralization.","[{'ForeName': 'R J', 'Initials': 'RJ', 'LastName': 'Wierichs', 'Affiliation': 'Department of Restorative, Preventive and Pediatric Dentistry, School of Dental Medicine, University of Bern, 3010 Bern, Switzerland; Department of Biohybrid & Medical Textiles, Institute of Applied Medical Engineering, RWTH Aachen University, 52074 Aachen, Germany. Electronic address: richard.wierichs@zmk.unibe.ch.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Musiol', 'Affiliation': 'Department of Operative Dentistry, Periodontology and Preventive Dentistry, RWTH Aachen University, Pauwelsstr. 30, 52074 Aachen, Germany.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Erdwey', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Medical Faculty, RWTH Aachen University, 52074 Aachen, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Esteves-Oliveira', 'Affiliation': 'Department of Operative Dentistry, Periodontology and Preventive Dentistry, RWTH Aachen University, Pauwelsstr. 30, 52074 Aachen, Germany; Department of Cariology, Endodontology and Periodontology, University of Leipzig, 04103 Leipzig, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Apel', 'Affiliation': 'Department of Biohybrid & Medical Textiles, Institute of Applied Medical Engineering, RWTH Aachen University, 52074 Aachen, Germany.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Meyer-Lueckel', 'Affiliation': 'Department of Restorative, Preventive and Pediatric Dentistry, School of Dental Medicine, University of Bern, 3010 Bern, Switzerland.'}]",Journal of dentistry,['10.1016/j.jdent.2020.103305']
3651,30993313,A randomized controlled trial of metformin on left ventricular hypertrophy in patients with coronary artery disease without diabetes: the MET-REMODEL trial.,"AIM


We tested the hypothesis that metformin may regress left ventricular hypertrophy (LVH) in patients who have coronary artery disease (CAD), with insulin resistance (IR) and/or pre-diabetes.
METHODS AND RESULTS


We randomly assigned 68 patients (mean age 65 ± 8 years) without diabetes who have CAD with IR and/or pre-diabetes to receive either metformin XL (2000 mg daily dose) or placebo for 12 months. Primary endpoint was change in left ventricular mass indexed to height1.7 (LVMI), assessed by magnetic resonance imaging. In the modified intention-to-treat analysis (n = 63), metformin treatment significantly reduced LVMI compared with placebo group (absolute mean difference -1.37 (95% confidence interval: -2.63 to -0.12, P = 0.033). Metformin also significantly reduced other secondary study endpoints such as: LVM (P = 0.032), body weight (P = 0.001), subcutaneous adipose tissue (P = 0.024), office systolic blood pressure (BP, P = 0.022) and concentration of thiobarbituric acid reactive substances, a biomarker for oxidative stress (P = 0.04). The glycated haemoglobin A1C concentration and fasting IR index did not differ between study groups at the end of the study.
CONCLUSION


Metformin treatment significantly reduced LVMI, LVM, office systolic BP, body weight, and oxidative stress. Although LVH is a good surrogate marker of cardiovascular (CV) outcome, conclusive evidence for the cardio-protective role of metformin is required from large CV outcomes trials.",2019,"The glycated haemoglobin A1C concentration and fasting IR index did not differ between study groups at the end of the study.
","['68 patients (mean age 65\u2009±\u20098 years) without diabetes who have CAD with IR and/or pre-diabetes to receive either', 'patients who have coronary artery disease (CAD), with insulin resistance (IR) and/or pre-diabetes', 'patients with coronary artery disease without diabetes']","['placebo', 'metformin', 'LVH', 'Metformin', 'metformin XL']","['LVMI, LVM, office systolic BP, body weight, and oxidative stress', 'subcutaneous adipose tissue', 'LVM', 'LVMI', 'concentration of thiobarbituric acid reactive substances, a biomarker for oxidative stress', 'glycated haemoglobin A1C concentration and fasting IR index', 'change in left ventricular mass indexed to height1.7 (LVMI), assessed by magnetic resonance imaging', 'left ventricular hypertrophy', 'body weight', 'office systolic blood pressure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0362046', 'cui_str': 'Prediabetes'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0149721', 'cui_str': 'Left Ventricular Hypertrophy'}]","[{'cui': 'C0442603', 'cui_str': 'Office (environment)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0222331', 'cui_str': 'Subcutaneous Fat'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0162781', 'cui_str': 'TBARs'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C4505389', 'cui_str': 'Glycosylated Hemoglobin A1c'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0340279', 'cui_str': 'Ventricular hypertrophy (disorder)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}]",68.0,0.423295,"The glycated haemoglobin A1C concentration and fasting IR index did not differ between study groups at the end of the study.
","[{'ForeName': 'Mohapradeep', 'Initials': 'M', 'LastName': 'Mohan', 'Affiliation': 'Division of Molecular and Clinical Medicine, School of Medicine, Ninewells Hospital and Medical School, University of Dundee, Dundee DD1 9SY, UK.'}, {'ForeName': 'Shaween', 'Initials': 'S', 'LastName': 'Al-Talabany', 'Affiliation': 'Division of Molecular and Clinical Medicine, School of Medicine, Ninewells Hospital and Medical School, University of Dundee, Dundee DD1 9SY, UK.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'McKinnie', 'Affiliation': 'NHS Tayside Clinical Radiology, Ninewells Hospital & Medical School, Dundee, DD1 9SY, UK.'}, {'ForeName': 'Ify R', 'Initials': 'IR', 'LastName': 'Mordi', 'Affiliation': 'Division of Molecular and Clinical Medicine, School of Medicine, Ninewells Hospital and Medical School, University of Dundee, Dundee DD1 9SY, UK.'}, {'ForeName': 'Jagdeep S S', 'Initials': 'JSS', 'LastName': 'Singh', 'Affiliation': 'Division of Molecular and Clinical Medicine, School of Medicine, Ninewells Hospital and Medical School, University of Dundee, Dundee DD1 9SY, UK.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Gandy', 'Affiliation': 'Department of Medical Physics, NHS Tayside, Ninewells Hospital & Medical School, Dundee, DD1 9SY, UK.'}, {'ForeName': 'Fatima', 'Initials': 'F', 'LastName': 'Baig', 'Affiliation': 'Division of Molecular and Clinical Medicine, School of Medicine, Ninewells Hospital and Medical School, University of Dundee, Dundee DD1 9SY, UK.'}, {'ForeName': 'Muhammad S', 'Initials': 'MS', 'LastName': 'Hussain', 'Affiliation': 'Division of Molecular and Clinical Medicine, School of Medicine, Ninewells Hospital and Medical School, University of Dundee, Dundee DD1 9SY, UK.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Bhalraam', 'Affiliation': 'Division of Molecular and Clinical Medicine, School of Medicine, Ninewells Hospital and Medical School, University of Dundee, Dundee DD1 9SY, UK.'}, {'ForeName': 'Faisel', 'Initials': 'F', 'LastName': 'Khan', 'Affiliation': 'Division of Molecular and Clinical Medicine, School of Medicine, Ninewells Hospital and Medical School, University of Dundee, Dundee DD1 9SY, UK.'}, {'ForeName': 'Anna-Maria', 'Initials': 'AM', 'LastName': 'Choy', 'Affiliation': 'Division of Molecular and Clinical Medicine, School of Medicine, Ninewells Hospital and Medical School, University of Dundee, Dundee DD1 9SY, UK.'}, {'ForeName': 'Shona', 'Initials': 'S', 'LastName': 'Matthew', 'Affiliation': 'Division of Molecular and Clinical Medicine, School of Medicine, Ninewells Hospital and Medical School, University of Dundee, Dundee DD1 9SY, UK.'}, {'ForeName': 'John Graeme', 'Initials': 'JG', 'LastName': 'Houston', 'Affiliation': 'Division of Molecular and Clinical Medicine, School of Medicine, Ninewells Hospital and Medical School, University of Dundee, Dundee DD1 9SY, UK.'}, {'ForeName': 'Allan D', 'Initials': 'AD', 'LastName': 'Struthers', 'Affiliation': 'Division of Molecular and Clinical Medicine, School of Medicine, Ninewells Hospital and Medical School, University of Dundee, Dundee DD1 9SY, UK.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'George', 'Affiliation': 'Division of Molecular and Clinical Medicine, School of Medicine, Ninewells Hospital and Medical School, University of Dundee, Dundee DD1 9SY, UK.'}, {'ForeName': 'Chim C', 'Initials': 'CC', 'LastName': 'Lang', 'Affiliation': 'Division of Molecular and Clinical Medicine, School of Medicine, Ninewells Hospital and Medical School, University of Dundee, Dundee DD1 9SY, UK.'}]",European heart journal,['10.1093/eurheartj/ehz203']
3652,30809700,Remotely programmed sacral neuromodulation for the treatment of patients with refractory overactive bladder: a prospective randomized controlled trial evaluating the safety and efficacy of a novel sacral neuromodulation device.,"PURPOSE


The efficacy and safety of a novel remotely programmed BetterStim sacral neuromodulation (SNM) system was evaluated in patients with refractory overactive bladder (OAB) in a prospective, controlled, multicenter trial.
METHODS


A total of 84 patients referred for SNM therapy from October 2015 to January 2018 were studied. Of the patients who qualified for implantation, 37 and 33 were randomly assigned to treatment and control groups, respectively. Patients in the treatment group underwent stimulation upon implantation, while stimulation was delayed in the control group for 3 months. Follow-up visits, consisting of voiding diary outcome, questionnaires regarding overactive bladder symptom score (OABSS) and quality of life were conducted at 1, 3, and 6-month post-implantation.
RESULTS


Compared with the control group, subjects in the treatment group exhibited statistically significant improvement in OAB symptoms at 3 months. The overall success rate was achieved in 72% of the treatment group, compared with 12% of the control group at 3 months. At 6 months, there were no significant differences in key voiding diary variables between the two groups. Further, this study demonstrated sustained improvement in urinary symptom interference in OAB patients. In addition, nearly all patients expressed great satisfaction with the remote-programming methods. No serious adverse events occurred, and device-related adverse events rate was 12.86%.
CONCLUSION


This clinical study demonstrates subjective and objective success of the BetterStim SNM system. Importantly, our data suggest that remote programming can be safely used as a viable option for the conventional programming with a high degree of patient satisfaction.",2019,"The overall success rate was achieved in 72% of the treatment group, compared with 12% of the control group at 3 months.","['patients with refractory overactive bladder (OAB', 'patients who qualified for implantation, 37 and 33', 'patients with refractory overactive bladder', '84 patients referred for SNM therapy from October 2015 to January 2018 were studied', 'OAB patients']","['Remotely programmed sacral neuromodulation', 'novel remotely programmed BetterStim sacral neuromodulation (SNM) system', 'novel sacral neuromodulation device']","['adverse events rate', 'urinary symptom interference', 'voiding diary outcome, questionnaires regarding overactive bladder symptom score (OABSS) and quality of life', 'key voiding diary variables', 'overall success rate', 'OAB symptoms', 'efficacy and safety', 'serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0878773', 'cui_str': 'Overactive Bladder'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0220819', 'cui_str': 'devices'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0426359', 'cui_str': 'Urinary symptoms (finding)'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0878773', 'cui_str': 'Overactive Bladder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",84.0,0.0365936,"The overall success rate was achieved in 72% of the treatment group, compared with 12% of the control group at 3 months.","[{'ForeName': 'Yaoguang', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Urology Department, Beijing Hospital, National Center of Gerontology, No. 1 DaHua Road, Dong Dan, Beijing, 100730, People's Republic of China.""}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': ""Urology Department, Beijing Chaoyang Hospital, Capital Medical University, Beijing, 100020, People's Republic of China.""}, {'ForeName': 'Xiaojun', 'Initials': 'X', 'LastName': 'Tian', 'Affiliation': ""Urology Department, Peking University Third Hospital, Beijing, 100191, People's Republic of China.""}, {'ForeName': 'Guoqing', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': ""Urology Department, China Rehabilitation Research Center, Capital Medical University, No. 10 North Road, Fengtai District, Beijing, 100068, People's Republic of China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""Urology Department, Qilu Hospital, Shandong University, Jinan, Shandong, 250012, People's Republic of China.""}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Urology Department, Beijing Tiantan Hospital, Capital Medical University, Beijing, 100050, People's Republic of China.""}, {'ForeName': 'Zhihui', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': ""Urology Department, Zhejiang Provincial People's Hospital, Hangzhou, Zhejiang, 310014, People's Republic of China.""}, {'ForeName': 'Zhongqing', 'Initials': 'Z', 'LastName': 'Wei', 'Affiliation': ""Urology Department, Second Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, 210000, People's Republic of China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': ""Urology Department, Beijing Hospital, National Center of Gerontology, No. 1 DaHua Road, Dong Dan, Beijing, 100730, People's Republic of China.""}, {'ForeName': 'Lulin', 'Initials': 'L', 'LastName': 'Ma', 'Affiliation': ""Urology Department, Peking University Third Hospital, Beijing, 100191, People's Republic of China.""}, {'ForeName': 'Benkang', 'Initials': 'B', 'LastName': 'Shi', 'Affiliation': ""Urology Department, Qilu Hospital, Shandong University, Jinan, Shandong, 250012, People's Republic of China.""}, {'ForeName': 'Limin', 'Initials': 'L', 'LastName': 'Liao', 'Affiliation': ""Urology Department, China Rehabilitation Research Center, Capital Medical University, No. 10 North Road, Fengtai District, Beijing, 100068, People's Republic of China. lmliao@263.net.""}, {'ForeName': 'Jianye', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Urology Department, Beijing Hospital, National Center of Gerontology, No. 1 DaHua Road, Dong Dan, Beijing, 100730, People's Republic of China. jianye_wangbhp@126.com.""}]",World journal of urology,['10.1007/s00345-019-02698-7']
3653,32096120,Burst Suppression: Causes and Effects on Mortality in Critical Illness.,"BACKGROUND


Burst suppression in mechanically ventilated intensive care unit (ICU) patients is associated with increased mortality. However, the relative contributions of propofol use and critical illness itself to burst suppression; of burst suppression, propofol, and critical illness to mortality; and whether preventing burst suppression might reduce mortality, have not been quantified.
METHODS


The dataset contains 471 adults from seven ICUs, after excluding anoxic encephalopathy due to cardiac arrest or intentional burst suppression for therapeutic reasons. We used multiple prediction and causal inference methods to estimate the effects connecting burst suppression, propofol, critical illness, and in-hospital mortality in an observational retrospective study. We also estimated the effects mediated by burst suppression. Sensitivity analysis was used to assess for unmeasured confounding.
RESULTS


The expected outcomes in a ""counterfactual"" randomized controlled trial (cRCT) that assigned patients to mild versus severe illness are expected to show a difference in burst suppression burden of 39%, 95% CI [8-66]%, and in mortality of 35% [29-41]%. Assigning patients to maximal (100%) burst suppression burden is expected to increase mortality by 12% [7-17]% compared to 0% burden. Burst suppression mediates 10% [2-21]% of the effect of critical illness on mortality. A high cumulative propofol dose (1316 mg/kg) is expected to increase burst suppression burden by 6% [0.8-12]% compared to a low dose (284 mg/kg). Propofol exposure has no significant direct effect on mortality; its effect is entirely mediated through burst suppression.
CONCLUSIONS


Our analysis clarifies how important factors contribute to mortality in ICU patients. Burst suppression appears to contribute to mortality but is primarily an effect of critical illness rather than iatrogenic use of propofol.",2020,"Propofol exposure has no significant direct effect on mortality; its effect is entirely mediated through burst suppression.
","['471 adults from seven ICUs, after excluding anoxic encephalopathy due to cardiac arrest or intentional burst suppression for therapeutic reasons', 'mechanically ventilated intensive care unit (ICU) patients', 'ICU patients']","['propofol', 'Propofol']","['burst suppression burden', 'mortality']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0003132', 'cui_str': 'Anoxic Encephalopathy'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0018790', 'cui_str': 'Cardiac Arrest'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C0429306', 'cui_str': 'Burst suppression (finding)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0684328', 'cui_str': 'Reasoning'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}]","[{'cui': 'C0429306', 'cui_str': 'Burst suppression (finding)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",,0.0609599,"Propofol exposure has no significant direct effect on mortality; its effect is entirely mediated through burst suppression.
","[{'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Hogan', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Haoqi', 'Initials': 'H', 'LastName': 'Sun', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Aboul Nour', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Jing', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Tabaeizadeh', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Maryum', 'Initials': 'M', 'LastName': 'Shoukat', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Farrukh', 'Initials': 'F', 'LastName': 'Javed', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Solomon', 'Initials': 'S', 'LastName': 'Kassa', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Muhammad M', 'Initials': 'MM', 'LastName': 'Edhi', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Elahe', 'Initials': 'E', 'LastName': 'Bordbar', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Gallagher', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Valdery Moura', 'Initials': 'VM', 'LastName': 'Junior', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Manohar', 'Initials': 'M', 'LastName': 'Ghanta', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Yu-Ping', 'Initials': 'YP', 'LastName': 'Shao', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Oluwaseun', 'Initials': 'O', 'LastName': 'Akeju', 'Affiliation': 'Department of Anesthesia, Critical Care, and Pain Medicine, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Cole', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Eric S', 'Initials': 'ES', 'LastName': 'Rosenthal', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Sahar', 'Initials': 'S', 'LastName': 'Zafar', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.'}, {'ForeName': 'M Brandon', 'Initials': 'MB', 'LastName': 'Westover', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA. mwestover@mgh.harvard.edu.'}]",Neurocritical care,['10.1007/s12028-020-00932-4']
3654,32058883,Comparison of the effects of simulation training and problem-based scenarios on the improvement of graduating nursing students to speak up about medication errors: A quasi-experimental study.,"BACKGROUND


Medication administration errors are common among new nurses. Nursing students might be less willing to speak up about errors because of a lack of knowledge and experience.
OBJECTIVES


To examine the effects of simulation training and problem-based scenarios on speaking up about medication errors among graduating nursing students.
DESIGN


Prospective, controlled experimental study design.
SETTING


A university four-year nursing program in Taiwan.
PARTICIPANTS


In total, 93 graduating nursing students in their last semester were recruited. Sixty-six students who received both a problem-based scenario and medication administration simulation training comprised the experimental group, while 27 students who received problem-based scenarios alone comprised the control group.
METHODS


Experimental group students underwent 2 h of simulation training. This training class was designed based on Kolb's experiential learning theory for knowledge development and speaking up about errors. Students in both groups administered medications in problem-based scenarios with eight embedded errors. Students' performance in speaking up about medication errors was directly observed and graded using an objective structured checklist. The McNeamer Chi-squared test, paired t-test, Z test, t-test, and Hedges' g effect size were conducted.
RESULTS


The number of times participants spoke up about medication errors significantly improved in both the experimental group (pre-test: 2.05 ± 1.12 and post-test 6.14 ± 1.25, t = 22.85, p<0.001) and control group (pretest: 2.04 ± 1.16 and post-test: 4.26 ± 1.63, t = 6.33, p<0.001). However, after the intervention, the mean number of times participants spoke up about medication errors in the experimental group was significantly higher than that in the control group (t = 5.99, p<0.001) in the post-test.
CONCLUSIONS


Simulation training exhibited more-significant improvements than problem-based scenarios. Nursing schools and hospitals should incorporate simulation training or at least problem-based scenarios to improve medication safety.",2020,"The number of times participants spoke up about medication errors significantly improved in both the experimental group (pre-test: 2.05 ± 1.12 and post-test 6.14 ± 1.25, t = 22.85, p<0.001) and control group (pretest: 2.04 ± 1.16 and post-test: 4.26 ± 1.63, t = 6.33, p<0.001).","['A university four-year nursing program in Taiwan', 'Sixty-six students who received both a problem-based scenario and medication administration simulation training comprised the experimental group, while 27 students who received', 'graduating nursing students to speak up about medication errors', '93 graduating nursing students in their last semester were recruited', 'graduating nursing students', 'Experimental group students underwent']","['2\xa0h of simulation training', 'problem-based scenarios alone comprised the control group', 'simulation training and problem-based scenarios']","[""Students' performance in speaking up about medication errors"", 'mean number of times participants spoke up about medication errors', 'number of times participants spoke up about medication errors']","[{'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0028678', 'cui_str': 'nursing care'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0039260', 'cui_str': 'Formosa'}, {'cui': 'C4517841', 'cui_str': 'Sixty-six'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3469597', 'cui_str': 'Medication treatment'}, {'cui': 'C4042947', 'cui_str': 'Simulation Training'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0588053', 'cui_str': 'Graduate (person)'}, {'cui': 'C0038496', 'cui_str': 'Pupil Nurses'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}, {'cui': 'C4087540', 'cui_str': 'Medication errors (SMQ)'}]","[{'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}, {'cui': 'C4042947', 'cui_str': 'Simulation Training'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}, {'cui': 'C4087540', 'cui_str': 'Medication errors (SMQ)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449809', 'cui_str': 'Number of times (qualifier value)'}]",93.0,0.019108,"The number of times participants spoke up about medication errors significantly improved in both the experimental group (pre-test: 2.05 ± 1.12 and post-test 6.14 ± 1.25, t = 22.85, p<0.001) and control group (pretest: 2.04 ± 1.16 and post-test: 4.26 ± 1.63, t = 6.33, p<0.001).","[{'ForeName': 'Shu-Yu', 'Initials': 'SY', 'LastName': 'Kuo', 'Affiliation': 'School of Nursing, College of Nursing, Taipei Medical University, 250 Wuxing Street, Taipei 11031, Taiwan. Electronic address: sykuo@tmu.edu.tw.'}, {'ForeName': 'Jen-Chieh', 'Initials': 'JC', 'LastName': 'Wu', 'Affiliation': 'School of Nursing, College of Nursing, Taipei Medical University, 250 Wuxing Street, Taipei 11031, Taiwan; Department of Emergency, Taipei Medical University Hospital, 252 Wuxing Street, Taipei 11031, Taiwan.'}, {'ForeName': 'Hui-Wen', 'Initials': 'HW', 'LastName': 'Chen', 'Affiliation': 'School of Nursing, College of Nursing, Taipei Medical University, 250 Wuxing Street, Taipei 11031, Taiwan; School of Nursing, National Yang-Ming University, No.155, Sec.2, Linong Street, Taipei 112, Taiwan.'}, {'ForeName': 'Chia-Jung', 'Initials': 'CJ', 'LastName': 'Chen', 'Affiliation': 'Department of Nursing, Taipei Medical University Hospital, 252 Wuxing Street, Taipei 11031, Taiwan.'}, {'ForeName': 'Sophia H', 'Initials': 'SH', 'LastName': 'Hu', 'Affiliation': 'School of Nursing, National Yang-Ming University, No.155, Sec.2, Linong Street, Taipei 112, Taiwan. Electronic address: sophiahu@ym.edu.tw.'}]",Nurse education today,['10.1016/j.nedt.2020.104359']
3655,31959167,"Metabolic and cardiorespiratory effects of decreasing lung hyperinflation with budesonide/formoterol in COPD: a randomized, double-crossover, placebo-controlled, multicenter trial.","BACKGROUND


Studies suggest that acute decreases in lung hyperinflation at rest improves cardiac function and increases lung vascular perfusion from decompression of a compromised heart. In those studies, changes in resting oxygen uptake induced by medications, an alternative explanation for compensatory increased cardiac function, were not explored.
METHODS


This double-blind, multicenter, double-crossover study enrolled adults with chronic obstructive pulmonary disease, resting hyperinflation, and > 10% improvement in inspiratory capacity after 2 inhalations of budesonide/formoterol 160/4.5 μg. Metabolic, cardiac, and ventilatory function were measured 60 min pre-/post-dose at each visit. Primary endpoint was change in resting oxygen uptake for budesonide/formoterol versus placebo.
RESULTS


Fifty-one patients (median age: 63 years) received treatment. Compared with placebo, budesonide/formoterol significantly increased resting oxygen uptake (mean change from baseline: 1.25 vs 11.37 mL/min; P = 0.007) as well as tidal volume and minute ventilation. This occurred despite improvements in the inspiratory capacity, forced vital capacity, and expiratory volume in 1 s. No significant treatment differences were seen for oxygen saturation, respiratory rate, and resting dyspnea. There was a numerical increase in oxygen pulse (oxygen uptake/heart rate). Correlations between inspiratory capacity and oxygen pulse were weak.
CONCLUSIONS


Budesonide/formoterol treatment in resting hyperinflated patients with COPD results in significant deflation. The increase in oxygen uptake and minute ventilation at lower lung volumes, without changes in heart rate and with minimal improvement in oxygen pulse, suggests increased oxygen demand as a contributor to increased cardiac function.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT02533505.",2020,"No significant treatment differences were seen for oxygen saturation, respiratory rate, and resting dyspnea.","['enrolled adults with chronic obstructive pulmonary disease, resting hyperinflation, and\u2009>\u200910% improvement in', '160/4.5\u2009μg', 'Fifty-one patients (median age: 63\u2009years', 'COPD']","['budesonide/formoterol', 'placebo', 'placebo, budesonide/formoterol', 'Budesonide/formoterol']","['inspiratory capacity', 'oxygen pulse (oxygen uptake/heart rate', 'heart rate', 'resting oxygen uptake', 'oxygen saturation, respiratory rate, and resting dyspnea', 'tidal volume and minute ventilation', 'inspiratory capacity and oxygen pulse', 'Metabolic, cardiac, and ventilatory function', 'oxygen uptake and minute ventilation', 'inspiratory capacity, forced vital capacity, and expiratory volume', 'lung hyperinflation']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0020449', 'cui_str': 'Hyperdistention (morphologic abnormality)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1276807', 'cui_str': 'Budesonide / formoterol'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0021610', 'cui_str': 'Inspiratory Capacity'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake (observable entity)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0231832', 'cui_str': 'Respiration Rate'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0040210', 'cui_str': 'Tidal Volume'}, {'cui': 'C1301655', 'cui_str': 'Minute ventilation'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C3714541', 'cui_str': 'Forced Vital Capacity'}, {'cui': 'C0231800', 'cui_str': 'Exhalation'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C1167782', 'cui_str': 'Lung hyperinflation'}]",,0.530708,"No significant treatment differences were seen for oxygen saturation, respiratory rate, and resting dyspnea.","[{'ForeName': 'Miguel J', 'Initials': 'MJ', 'LastName': 'Divo', 'Affiliation': ""Pulmonary and Critical Care Division, Brigham and Women's Hospital, Harvard Medical School, 75 Francis Street, Boston, MA, 02115, USA. mdivo@bwh.harvard.edu.""}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'DePietro', 'Affiliation': 'AstraZeneca LP, Wilmington, DE, USA.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Horton', 'Affiliation': 'AstraZeneca LP, Wilmington, DE, USA.'}, {'ForeName': 'Cherie A', 'Initials': 'CA', 'LastName': 'Maguire', 'Affiliation': ""Pulmonary and Critical Care Division, Brigham and Women's Hospital, Harvard Medical School, 75 Francis Street, Boston, MA, 02115, USA.""}, {'ForeName': 'Bartolome R', 'Initials': 'BR', 'LastName': 'Celli', 'Affiliation': ""Pulmonary and Critical Care Division, Brigham and Women's Hospital, Harvard Medical School, 75 Francis Street, Boston, MA, 02115, USA.""}]",Respiratory research,['10.1186/s12931-020-1288-3']
3656,31662396,HOspital care versus TELemonitoring in high-risk pregnancy (HOTEL): study protocol for a multicentre non-inferiority randomised controlled trial.,"INTRODUCTION


Pregnant women faced with complications of pregnancy often require long-term hospital admission for maternal and/or fetal monitoring. Antenatal admissions cause a burden to patients as well as hospital resources and costs. A telemonitoring platform connected to wireless cardiotocography (CTG) and automated blood pressure (BP) devices can be used for telemonitoring in pregnancy. Home telemonitoring might improve autonomy and reduce admissions and thus costs. The aim of this study is to compare the effects on patient safety, satisfaction and cost-effectiveness of  ho spital care versus  tel emonitoring (HOTEL) as an obstetric care strategy in high-risk pregnancies requiring daily monitoring.
METHODS AND ANALYSIS


The HOTEL trial is an ongoing multicentre randomised controlled clinical trial with a non-inferiority design. Eligible pregnant women are >26+0 weeks of singleton gestation requiring monitoring because of pre-eclampsia (hypertension with proteinuria), fetal growth restriction, preterm rupture of membranes without contractions, recurrent reduced fetal movements or an intrauterine fetal death in a previous pregnancy.Randomisation takes place between traditional hospitalisation (planned n=208) versus telemonitoring (planned n=208) until delivery. Telemonitoring at home is facilitated with Sense4Baby CTG devices, Microlife BP monitor and daily telephone calls with an obstetric healthcare professional as well as weekly hospital visits.Primary outcome is a composite of adverse perinatal outcome, defined as perinatal mortality, 5 min Apgar <7 or arterial cord blood pH <7.05, maternal morbidity (eclampsia, HELLP (hemolysis, elevated liver enzymes, and low platelets) syndrome, thromboembolic event), neonatal intensive care admission and caesarean section rate. Patient satisfaction and preference of care will be assessed using validated questionnaires. We will perform an economic analysis. Outcomes will be analysed according to the intention to treat principle.
ETHICS AND DISSEMINATION


The study protocol was approved by the Ethics Committee of the Utrecht University Medical Center and the boards of all six participating centres. Trial results will be submitted to peer-reviewed journals.
TRIAL REGISTRATION NUMBER


NTR6076.",2019,Randomisation takes place between traditional hospitalisation (planned n=208) versus telemonitoring (planned n=208) until delivery.,"['Utrecht University Medical Center and the boards of all six participating centres', 'Pregnant women faced with complications of pregnancy often require long-term hospital admission for maternal and/or fetal monitoring', 'high-risk pregnancies requiring daily monitoring', 'Eligible pregnant women are >26+0 weeks of singleton gestation requiring monitoring because of pre-eclampsia (hypertension with proteinuria), fetal growth restriction, preterm rupture of membranes without contractions, recurrent reduced fetal movements or an intrauterine fetal death in a previous pregnancy']","['ho spital care versus  tel emonitoring (HOTEL', 'wireless cardiotocography (CTG) and automated blood pressure (BP) devices', 'HOspital care versus TELemonitoring']","['composite of adverse perinatal outcome, defined as perinatal mortality, 5 min Apgar <7\u2009or arterial cord blood pH <7.05, maternal morbidity (eclampsia, HELLP (hemolysis, elevated liver enzymes, and low platelets) syndrome, thromboembolic event), neonatal intensive care admission and caesarean section rate', 'patient safety, satisfaction and cost-effectiveness', 'Patient satisfaction and preference of care']","[{'cui': 'C0000872', 'cui_str': 'University Medical Centers'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0032962', 'cui_str': 'Pregnancy Complications'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission (procedure)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0015945', 'cui_str': 'Fetal Monitoring'}, {'cui': 'C0242786', 'cui_str': 'High-Risk Pregnancy'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0032914', 'cui_str': 'EPH Toxemias'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0015934', 'cui_str': 'Intrauterine Growth Restriction'}, {'cui': 'C0015944', 'cui_str': 'Premature Rupture of Membrane (Pregnancy)'}, {'cui': 'C1140999', 'cui_str': 'Contraction (finding)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0235659', 'cui_str': 'Reduced fetal movement (finding)'}, {'cui': 'C0694756', 'cui_str': 'Intrauterine (qualifier value)'}, {'cui': 'C0015927', 'cui_str': 'Fetal Demise'}, {'cui': 'C0600457', 'cui_str': 'Gravidity'}]","[{'cui': 'C0442514', 'cui_str': 'Hotel (environment)'}, {'cui': 'C0007208', 'cui_str': 'Electronic Fetal Monitoring'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0031062', 'cui_str': 'Perinatal Mortality'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0162371', 'cui_str': 'Cord Blood'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0013537', 'cui_str': 'Eclampsia'}, {'cui': 'C2937287', 'cui_str': 'Hemolysis (observable entity)'}, {'cui': 'C0235996', 'cui_str': 'Hepatic enzyme increased'}, {'cui': 'C0392386', 'cui_str': 'Platelet count below reference range'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolism'}, {'cui': 'C0021711', 'cui_str': 'Infant, Newborn, Intensive Care'}, {'cui': 'C0007876', 'cui_str': 'C-Section (OB)'}, {'cui': 'C1113679'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}]",,0.294536,Randomisation takes place between traditional hospitalisation (planned n=208) versus telemonitoring (planned n=208) until delivery.,"[{'ForeName': 'Josephus F M', 'Initials': 'JFM', 'LastName': 'van den Heuvel', 'Affiliation': 'Obstetrics and Gynaecology, UMC Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Wessel', 'Initials': 'W', 'LastName': 'Ganzevoort', 'Affiliation': 'Obstetrics and Gynaecology, Amsterdam Universitair Medische Centra, Amsterdam, The Netherlands.'}, {'ForeName': 'Jiska M', 'Initials': 'JM', 'LastName': 'De Haan-Jebbink', 'Affiliation': 'Obstetrics and Gynaecology, OLVG, Amsterdam, The Netherlands.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'van der Ham', 'Affiliation': 'Obstetrics and Gynaecology, Martini Ziekenhuis, Groningen, The Netherlands.'}, {'ForeName': 'Koen L', 'Initials': 'KL', 'LastName': 'Deurloo', 'Affiliation': 'Obstetrics and Gynaecology, Diakonessenhuis, Utrecht, The Netherlands.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Seeber', 'Affiliation': 'Obstetrics and Gynaecology, Sint Antonius Hospital, Nieuwegein, The Netherlands.'}, {'ForeName': 'Arie', 'Initials': 'A', 'LastName': 'Franx', 'Affiliation': 'Obstetrics and Gynaecology, UMC Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Mireille N', 'Initials': 'MN', 'LastName': 'Bekker', 'Affiliation': 'Obstetrics and Gynaecology, UMC Utrecht, Utrecht, The Netherlands m.n.bekker-3@umcutrecht.nl.'}]",BMJ open,['10.1136/bmjopen-2019-031700']
3657,32019222,"Effect of Oral Probiotic  Lactobacillus rhamnosus  GR-1 and  Lactobacillus   reuteri  RC-14 on the Vaginal Microbiota, Cytokines and Chemokines in Pregnant Women.","Spontaneous preterm birth is associated with vaginal microbial dysbiosis. As certain strains of lactobacilli help restore homeostasis in non-pregnant women, the goal was to determine the effect of  Lactobacillus rhamnosus  GR-1 and  Lactobacillus reuteri  RC-14 administered orally, twice daily for 12 weeks on the vaginal microbiota, cytokines and chemokines of low-risk pregnant women. A double-blind, placebo-controlled, randomized trial comparing probiotic lactobacilli to placebo daily was performed in 86 asymptomatic pregnant women who had an Intermediate or Bacterial Vaginosis Nugent score at 13 weeks. After drop outs, 32 women receiving probiotics and 34 receiving placebo completed the study. The Nugent score returned to normal in 30% of the women in both groups at 28 weeks and was maintained until 35 weeks. The majority of subjects had normal pregnancy outcomes. Ninety-three bacterial species were detected at 13 weeks, with  Lactobacillus iners, Lactobacillus crispatus, Gardnerella vaginalis  and  Atopobium vaginae  being the most abundant across pregnancy. There was no difference in the Shannon diversity index between the probiotic and placebo groups at 13, 28 or 35 weeks. Almost all subjects consumed fermented foods and many of the organisms in the vagina are also known to be present in fermented foods. Interleukin-4 in the placebo group and Interleukin-10 in both probiotic and placebo groups increased slightly at 28 weeks but were not different at 35 weeks when compared to 13 weeks. In conclusion, this study showed no adverse issues resulting from 12 week use of probiotic  Lactobacillus  strains GR-1 and RC-14 during pregnancy in women at low risk for premature birth. The vaginal microbiota demonstrated flux irrespective of this oral probiotic administration.",2020,Interleukin-4 in the placebo group and Interleukin-10 in both probiotic and placebo groups increased slightly at 28 weeks but were not different at 35 weeks when compared to 13 weeks.,"['women at low risk for premature birth', 'low-risk pregnant women', 'non-pregnant women', '86 asymptomatic pregnant women who had an Intermediate or Bacterial Vaginosis Nugent score at 13 weeks', '32 women receiving probiotics and 34 receiving', 'Pregnant Women']","['placebo', 'RC-14', 'Lactobacillus reuteri', 'probiotic lactobacilli to placebo']","['Shannon diversity index', 'Vaginal Microbiota, Cytokines and Chemokines', 'Nugent score']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0151526', 'cui_str': 'Premature Birth'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0085166', 'cui_str': 'Vaginitis, Nonspecific'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0317625', 'cui_str': 'Lactobacillus reuteri'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}]","[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0282554', 'cui_str': 'Cytokines, Chemotactic'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",86.0,0.171937,Interleukin-4 in the placebo group and Interleukin-10 in both probiotic and placebo groups increased slightly at 28 weeks but were not different at 35 weeks when compared to 13 weeks.,"[{'ForeName': 'Siwen', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': 'Departments of Physiology and Obstetrics and Gynecology, University of Toronto, Toronto, ON M5G 1E2, Canada.'}, {'ForeName': 'Gregor', 'Initials': 'G', 'LastName': 'Reid', 'Affiliation': 'Departments of Microbiology and Immunology, The University of Western Ontario, London, ON N6A 5C1, Canada.'}, {'ForeName': 'John R G', 'Initials': 'JRG', 'LastName': 'Challis', 'Affiliation': 'Departments of Physiology and Obstetrics and Gynecology, University of Toronto, Toronto, ON M5G 1E2, Canada.'}, {'ForeName': 'Gregory B', 'Initials': 'GB', 'LastName': 'Gloor', 'Affiliation': 'Lawson Health Research Institute, 268 Grosvenor Street, London, ON N6A 4V2, Canada.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Asztalos', 'Affiliation': 'Department of Newborn & Developmental Paediatrics, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, ON M5A 1B2, Canada.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Money', 'Affiliation': 'Department of Obstetrics and Gynecology, University of British Columbia, 317-2194 Health Sciences Mall, Vancouver, BC V6T 1Z3, Canada.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Seney', 'Affiliation': 'Lawson Health Research Institute, 268 Grosvenor Street, London, ON N6A 4V2, Canada.'}, {'ForeName': 'Alan D', 'Initials': 'AD', 'LastName': 'Bocking', 'Affiliation': 'Departments of Physiology and Obstetrics and Gynecology, University of Toronto, Toronto, ON M5G 1E2, Canada.'}]",Nutrients,['10.3390/nu12020368']
3658,32187097,Does Surgical-site Multimodal Drug Injection After Palmar Plating of Distal Radius Fractures Improve Pain Scores?,"BACKGROUND


Although palmar locked plating is a stable fixation method frequently used to treat unstable distal radius fractures (DRFs), surgical treatment may be painful, and so interventions to decrease that pain might improve our patients' experiences with surgery. Some surgeons use local multimodal drug injections to decrease postoperative pain after lower-extremity arthroplasty, but little is known about the effectiveness of a local multimodal drug injection in patients who undergo palmar plating for DRFs.
QUESTIONS/PURPOSES


(1) Do patients who receive a local multimodal drug injection after palmar plating for unstable DRFs have better pain scores at 4, 8, 24, and 48 hours after surgery than patients who have not received such an injection? (2) Do patients who receive a local multimodal drug injection have lower fentanyl consumption and administration of anti-emetic drugs within the first 48 hours after surgery than patients who have not received such an injection?
METHODS


A randomized controlled study was performed between August 2018 and August 2019 at a single tertiary care referral center. Patients who underwent palmar plating for DRFs under general anesthesia were eligible for inclusion. Patients were allocated into two groups: Those who received a local multimodal drug injection, and those who did not receive an injection. During the study period, 101 patients treated with palmar plating for DRFs met the inclusion criteria and were enrolled and randomized. Fifty-two patients were allocated to the multimodal injection group and 49 were allocated to the control group. Three patients (two in the multimodal injection group and one in the control group) were excluded after randomization because their pain level was not registered at any timepoint and so they could not be analyzed; our analysis was by intention to treat, and there was no crossover. After palmar plating, patients in the multimodal injection group received an injection of ropivacaine (10 mL), morphine (5 mL), ceftezole (5 mL) as well as normal saline (5 mL) to the periosteal area, pronator quadratus muscle, subcutaneous area, and skin. There were no differences between the groups in terms of age (62 years ± 13 years in the multimodal injection group versus 62 years ± 11 years in the control group; p = 0.93), gender (84% [42 of 50] women in the multimodal injection group versus 77% [37 of 48] women in the control group; p = 0.39), hand dominance (70% [35 of 50] dominant wrist in the multimodal injection group versus 60% [29 of 48] dominant wrist in the control group; p = 0.32) and AO/Orthopaedic Trauma Association (AO/OTA) classification (p = 0.57). All patients underwent treatment with the same perioperative protocol, and 25 μg of fentanyl was injected intravenously when a patient complained of pain and asked for additional pain control after surgery. In addition, when a patient complained of nausea or vomiting associated with fentanyl use, an anti-emetic drug was also injected. All nursing staff who administered the analgesics and anti-emetic drugs were blinded to treatment allocation. These two groups were compared regarding their pain level using a 100-mm VAS at 4, 8, 24, and 48 hours postoperatively. The minimum clinically important difference (MCID) for the VAS score was set to 20 mm. VAS scores were also collected by nursing staff who remained blinded to the treatment allocation. The total amount of fentanyl use and the number of patients who received anti-emetic drugs associated with administration of fentanyl within the first 48 hours were also recorded.
RESULTS


With an MCID of 20 points, we found no clinically important reduction in VAS scores among patients who received a local multimodal injection compared with those who did not receive an injection at 4 hours (34 ± 15 versus 41 ± 20, mean difference -7.079 [95% CI -13.986 to -0.173]; p = 0.045), 8 hours (27 ± 16 versus 40 ± 19, mean difference -12.263 [95% CI -19.174 to -5.353]; p = 0.001), 24 hours (18 ± 12 versus 29 ± 20, mean difference -11.042 [95% CI -17.664 to -4.419]; p = 0.001), and 48 hours (9 ± 8 versus 10 ± 6, mean difference -1.318 [95% CI -4.000 to 1.365]; p = 0.33). Within the first 48 hours after surgery, fentanyl consumption was lower in patients receiving a local multimodal injection than in control patients (25 μg [range 0-100 μg] versus 37.5 μg [range 0-125 μg], difference of medians -12.5; p = 0.01). There was also a difference between the study groups in terms of the proportion of patients who received anti-emetic medications (16% [8 of 50] in the multimodal injection group versus 35% [17 of 48] in the control group, odds ratio = 2.879 [95% CI 1.102 to 7.519]; p = 0.03).
CONCLUSIONS


Our data suggest that patients who received a surgical-site multimodal analgesic injection after palmar plating for a distal radius fracture had no clinically important reduction in pain scores, but they did consume lower doses of opioid analgesics and fewer of these patients received anti-emetic drugs within 2 days of surgery. The high-potency opioids or other analgesia usually used for postoperative pain management have many side effects. Thus, reducing additional analgesia is as important as postoperative pain management and a surgical-site multimodal analgesic injection is one of the methods to achieve this a goal.
LEVEL OF EVIDENCE


Level I, therapeutic study.",2020,"Within the first 48 hours after surgery, fentanyl consumption was lower in patients receiving a local multimodal injection than in control patients (25 μg [range 0-100 μg] versus 37.5 μg [range 0-125 μg], difference of medians -12.5; p = 0.01).","['101 patients treated with palmar plating for DRFs met the inclusion criteria and were enrolled and randomized', 'patients who undergo palmar plating for DRFs', 'Distal Radius Fractures', 'Fifty-two patients', 'August 2018 and August 2019 at a single tertiary care referral center', 'Patients who underwent palmar plating for DRFs under general anesthesia were eligible for inclusion']","['fentanyl', 'morphine (5 mL), ceftezole (5 mL) as well as normal saline', 'multimodal injection', 'palmar locked plating', 'ropivacaine', 'local multimodal drug injection, and those who did not receive an injection']","['Pain Scores', 'VAS scores', 'pain scores', 'VAS score', 'fentanyl consumption', 'pain level', 'nausea or vomiting', 'postoperative pain']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C1720969', 'cui_str': 'Metacarpophalangeal Volar Plate'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius (body structure)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C4319570', 'cui_str': 'Fifty-two'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0055013', 'cui_str': 'ceftezol'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C1184147', 'cui_str': 'Palmar (qualifier value)'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}]",52.0,0.171431,"Within the first 48 hours after surgery, fentanyl consumption was lower in patients receiving a local multimodal injection than in control patients (25 μg [range 0-100 μg] versus 37.5 μg [range 0-125 μg], difference of medians -12.5; p = 0.01).","[{'ForeName': 'Hyoung-Seok', 'Initials': 'HS', 'LastName': 'Jung', 'Affiliation': 'H.-S. Jung, K.-J. Chun, J. Y. Kim, J. Lee, J. S. Lee, Department of Orthopaedic Surgery, Medical Center of Chung-Ang University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Kwang-Jin', 'Initials': 'KJ', 'LastName': 'Chun', 'Affiliation': ''}, {'ForeName': 'Jae Yoon', 'Initials': 'JY', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Jeongik', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Jae Sung', 'Initials': 'JS', 'LastName': 'Lee', 'Affiliation': ''}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000001212']
3659,32176862,"The Effect of Exercise Training on Total Daily Energy Expenditure and Body Composition in Weight-Stable Adults: A Randomized, Controlled Trial.","BACKGROUND


The present study examined, among weight-stable overweight or obese adults, the effect of increasing doses of exercise energy expenditure (EEex) on changes in total daily energy expenditure (TDEE), total body energy stores, and body composition.
METHODS


Healthy, sedentary overweight/obese young adults were randomized to one of 3 groups for a period of 26 weeks: moderate-exercise (EEex goal of 17.5 kcal/kg/wk), high-exercise (EEex goal of 35 kcal/kg/wk), or observation group. Individuals maintained body weight within 3% of baseline. Pre/postphysical activity between-group measurements included body composition, calculated energy intake, TDEE, energy stores, and resting metabolic rate.
RESULTS


Sixty weight-stable individuals completed the protocols. Exercise groups increased EEex in a stepwise manner compared with the observation group (P < .001). There was no group effect on changes in TDEE, energy intake, fat-free mass, or resting metabolic rate. Fat mass and energy stores decreased among the females in the high-exercise group (P = .007).
CONCLUSIONS


The increase in EEex did not result in an equivalent increase in TDEE. There was a sex difference in the relationship among energy balance components. These results suggest a weight-independent compensatory response to exercise training with potentially a sex-specific adjustment in body composition.",2020,"There was no group effect on changes in TDEE, energy intake, fat-free mass, or resting metabolic rate.","['Healthy, sedentary overweight/obese young adults', 'Weight-Stable Adults', 'Sixty weight-stable individuals completed the protocols', 'weight-stable overweight or obese adults']","['Exercise Training', 'exercise energy expenditure (EEex', 'moderate-exercise (EEex goal of 17.5\xa0kcal/kg/wk), high-exercise (EEex goal of 35\xa0kcal/kg/wk), or observation group']","['Pre/postphysical activity', 'body composition, calculated energy intake, TDEE, energy stores, and resting metabolic rate', 'total daily energy expenditure (TDEE), total body energy stores, and body composition', 'EEex', 'changes in TDEE, energy intake, fat-free mass, or resting metabolic rate', 'Individuals maintained body weight', 'Fat mass and energy stores', 'TDEE', 'Total Daily Energy Expenditure and Body Composition']","[{'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0424657', 'cui_str': 'Weight static'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0014272', 'cui_str': 'Energy Expenditure'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0439259', 'cui_str': 'kilocalorie'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0444686', 'cui_str': 'Calculated (qualifier value)'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C4082350', 'cui_str': 'Resting Metabolic Rate'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0014272', 'cui_str': 'Energy Expenditure'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass (observable entity)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}]",,0.0733661,"There was no group effect on changes in TDEE, energy intake, fat-free mass, or resting metabolic rate.","[{'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Hand', 'Affiliation': ''}, {'ForeName': 'Robin P', 'Initials': 'RP', 'LastName': 'Shook', 'Affiliation': ''}, {'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': ""O'Connor"", 'Affiliation': ''}, {'ForeName': 'Madison M', 'Initials': 'MM', 'LastName': 'Kindred', 'Affiliation': ''}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Schumacher', 'Affiliation': ''}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Drenowatz', 'Affiliation': ''}, {'ForeName': 'Amanda E', 'Initials': 'AE', 'LastName': 'Paluch', 'Affiliation': ''}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Burgess', 'Affiliation': ''}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Blundell', 'Affiliation': ''}, {'ForeName': 'Steven N', 'Initials': 'SN', 'LastName': 'Blair', 'Affiliation': ''}]",Journal of physical activity & health,['10.1123/jpah.2019-0415']
3660,31839677,Dual-specificity protein phosphatase DUSP4 regulates response to MEK inhibition in BRAF wild-type melanoma.,"BACKGROUND


Aiming to improve treatment options for BRAF wild-type melanoma, we previously conducted the DOC-MEK study of docetaxel with MEK inhibitor (MEKi) selumetinib or placebo, revealing trends to prolongation of progression-free survival (hazard ratio 0.75, P = 0.130), and improved response rates (32% vs 14%, P = 0.059) with docetaxel plus selumetinib. NRAS status did not associate with outcome. Here, the aim was to identify novel biomarkers of response to MEKi.
METHODS


A MEK 6 gene signature was quantified using NanoString and correlated with clinical outcomes. Two components of the gene signature were investigated by gene silencing in BRAF/NRAS wild-type melanoma cells.
RESULTS


In melanomas of patients on the selumetinib but not the placebo arm, two gene signature components, dual-specificity protein phosphatase 4 (DUSP4) and ETS translocation variant 4 (ETV4), were expressed more highly in responders than non-responders. In vitro, ETV4 depletion inhibited cell survival but did not influence sensitivity to MEKi selumetinib or trametinib. In contrast, DUSP4-depleted cells showed enhanced cell survival and increased resistance to both selumetinib and trametinib.
CONCLUSIONS


ETV4 and DUSP4 associated with clinical response to docetaxel plus selumetinib. DUSP4 depletion induced MEKi resistance, suggesting that DUSP4 is not only a biomarker but also a mediator of MEKi sensitivity.
CLINICAL TRIAL REGISTRATION


DOC-MEK (EudraCT no: 2009-018153-23).",2020,"In vitro, ETV4 depletion inhibited cell survival but did not influence sensitivity to MEKi selumetinib or trametinib.",['BRAF wild-type melanoma'],"['docetaxel plus selumetinib', 'docetaxel with MEK inhibitor (MEKi) selumetinib or placebo', 'placebo', 'EudraCT']","['response rates', 'dual-specificity protein phosphatase 4 (DUSP4) and ETS translocation variant 4 (ETV4', 'cell survival']","[{'cui': 'C0445392', 'cui_str': 'Wild (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}]","[{'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C2980074'}, {'cui': 'C0752313', 'cui_str': 'MAPK-ERK Kinases'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0214716', 'cui_str': 'protein phosphatase X'}, {'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}, {'cui': 'C0007620', 'cui_str': 'Cell Viability'}]",,0.222807,"In vitro, ETV4 depletion inhibited cell survival but did not influence sensitivity to MEKi selumetinib or trametinib.","[{'ForeName': 'Avinash', 'Initials': 'A', 'LastName': 'Gupta', 'Affiliation': 'Department of Medical Oncology, The Christie NHS Foundation Trust, Manchester, UK. avinash.gupta@christie.nhs.uk.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Towers', 'Affiliation': 'Department of Oncology, Old Road Campus Research Building, University of Oxford, Oxford, UK.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Willenbrock', 'Affiliation': 'Department of Oncology, Old Road Campus Research Building, University of Oxford, Oxford, UK.'}, {'ForeName': 'Roz', 'Initials': 'R', 'LastName': 'Brant', 'Affiliation': 'Translational Science, Oncology iMED, AstraZeneca, Macclesfield, UK.'}, {'ForeName': 'Darren Richard', 'Initials': 'DR', 'LastName': 'Hodgson', 'Affiliation': 'Translational Science, Oncology iMED, AstraZeneca, Macclesfield, UK.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Sharpe', 'Affiliation': 'Oncology iMED, AstraZeneca, Cambridge, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Smith', 'Affiliation': 'Cancer BioSciences, AstraZeneca, Cambridge, UK.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Cutts', 'Affiliation': 'Molecular Diagnostics Centre, John Radcliffe Hospital, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Schuh', 'Affiliation': 'Department of Oncology, Old Road Campus Research Building, University of Oxford, Oxford, UK.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Asher', 'Affiliation': 'Department of Cellular Pathology, John Radcliffe Hospital, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Myers', 'Affiliation': 'Experimental Cancer Medicine Centre, Oxford, UK.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Love', 'Affiliation': 'Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Collins', 'Affiliation': 'Oncology Clinical Trials Office, University of Oxford, Oxford, UK.'}, {'ForeName': 'Adelyn', 'Initials': 'A', 'LastName': 'Wise', 'Affiliation': 'Oncology Clinical Trials Office, University of Oxford, Oxford, UK.'}, {'ForeName': 'Mark Roy', 'Initials': 'MR', 'LastName': 'Middleton', 'Affiliation': 'Department of Oncology, Old Road Campus Research Building, University of Oxford, Oxford, UK.'}, {'ForeName': 'Valentine Moya', 'Initials': 'VM', 'LastName': 'Macaulay', 'Affiliation': 'Department of Oncology, Old Road Campus Research Building, University of Oxford, Oxford, UK.'}]",British journal of cancer,['10.1038/s41416-019-0673-5']
3661,31820537,Initiation of sacubitril/valsartan shortly after hospitalisation for acutely decompensated heart failure in patients with newly diagnosed (de novo) heart failure: a subgroup analysis of the TRANSITION study.,"AIMS


Sacubitril/valsartan has shown efficacy and tolerability in patients with heart failure (HF) and reduced ejection fraction (HFrEF) in the ambulatory setting (PARADIGM-HF), and following stabilisation of acutely decompensated HF (ADHF) (PIONEER-HF and TRANSITION). However, data are lacking for the initiation of sacubitril/valsartan in newly diagnosed (de novo) HFrEF. Here, we assess the tolerability of initiating sacubitril/valsartan following ADHF in TRANSITION subgroups of patients with a de novo vs. prior diagnosis of HFrEF.
METHODS AND RESULTS


TRANSITION randomised 1002 patients to pre- and post-discharge initiation of sacubitril/valsartan (analysis set n = 991, following exclusions for mis-randomisation). In this post-hoc analysis, tolerability to sacubitril/valsartan [proportion of patients achieving target dose (97/103 mg b.i.d.) at 10 weeks post-randomisation], adverse events (AEs) and serious AEs (SAEs) were compared in de novo (n = 286) and prior HFrEF (n = 705) subgroups. More de novo than prior HFrEF patients achieved target dose at Week 10 (56% vs. 45%; relative risk ratio 1.30, 95% confidence interval 1.12-1.52, P < 0.001), and fewer had SAEs and permanent treatment discontinuations. Initiation of sacubitril/valsartan did not prevent the concomitant initiation and up-titration of guideline-directed HF therapies. De novo patients showed faster and greater decreases in N-terminal pro-B-type natriuretic peptide and high-sensitivity troponin-T, and lower rates of HF and all-cause rehospitalisation vs. prior HFrEF.
CONCLUSIONS


After ADHF, first-line initiation of sacubitril/valsartan in de novo HFrEF, alongside the initiation of other guideline-directed therapies, is feasible and is associated with a better risk-benefit profile than in patients with prior HFrEF. Early intervention with sacubitril/valsartan may be considered to delay disease progression in patients with de novo HFrEF.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov, NCT02661217.",2020,"; relative risk ratio 1.30, 95% confidence interval 1.12-1.52, P < 0.001), and fewer had SAEs and permanent treatment discontinuations.","['subgroups of patients with a de novo vs. prior diagnosis of HFrEF', 'patients with de novo HFrEF', '1002 patients to pre- and post-discharge initiation of sacubitril/valsartan (analysis set\u2009n\xa0=\xa0991, following exclusions for mis-randomisation', 'patients with heart failure (HF', 'acutely decompensated heart failure in patients with newly diagnosed (de novo) heart failure', 'patients with prior HFrEF']","['sacubitril/valsartan', 'Sacubitril/valsartan']","['efficacy and tolerability', 'adverse events (AEs) and serious AEs (SAEs', 'tolerability']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332132', 'cui_str': 'Prior diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C4033631', 'cui_str': 'sacubitril / valsartan'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0205434', 'cui_str': 'Decompensated (qualifier value)'}]","[{'cui': 'C4033631', 'cui_str': 'sacubitril / valsartan'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}]",1002.0,0.120751,"; relative risk ratio 1.30, 95% confidence interval 1.12-1.52, P < 0.001), and fewer had SAEs and permanent treatment discontinuations.","[{'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Senni', 'Affiliation': 'Cardiology Division, Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo, Italy.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Wachter', 'Affiliation': 'Clinic and Policlinic for Cardiology, University Hospital Leipzig, Leipzig, Germany.'}, {'ForeName': 'Klaus K', 'Initials': 'KK', 'LastName': 'Witte', 'Affiliation': 'Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Straburzynska-Migaj', 'Affiliation': '1st Department of Cardiology, University of Medical Sciences, Poznan, Poland.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Belohlavek', 'Affiliation': 'General Teaching Hospital, Charles University in Prague, Prague, Czech Republic.'}, {'ForeName': 'Candida', 'Initials': 'C', 'LastName': 'Fonseca', 'Affiliation': 'Heart Failure Unit, Internal Medicine Department, Hospital de São Francisco Xavier, CHLO, NOVA Medical School, Faculdade de Ciências Médicas, Universidade Nova de Lisboa, Lisbon, Portugal.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Mueller', 'Affiliation': 'University Hospital Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Lonn', 'Affiliation': 'McMaster University and Hamilton Health Sciences, Hamilton, ON, Canada.'}, {'ForeName': 'Arhit', 'Initials': 'A', 'LastName': 'Chakrabarti', 'Affiliation': 'Novartis Pharmaceuticals, Hyderabad, India.'}, {'ForeName': 'Weibin', 'Initials': 'W', 'LastName': 'Bao', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Adele', 'Initials': 'A', 'LastName': 'Noe', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Heike', 'Initials': 'H', 'LastName': 'Schwende', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Dmytro', 'Initials': 'D', 'LastName': 'Butylin', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Domingo', 'Initials': 'D', 'LastName': 'Pascual-Figal', 'Affiliation': 'Cardiology Department, Hospital Universitario Virgen de la Arrixaca, Universidad de Murcia, Murcia, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European journal of heart failure,['10.1002/ejhf.1670']
3662,31738378,Effect of Internet-Distributed HIV Self-tests on HIV Diagnosis and Behavioral Outcomes in Men Who Have Sex With Men: A Randomized Clinical Trial.,"Importance


Undiagnosed HIV infection results in delayed access to treatment and increased transmission. Self-tests for HIV may increase awareness of infection among men who have sex with men (MSM).
Objective


To evaluate the effect of providing HIV self-tests on frequency of testing, diagnoses of HIV infection, and sexual risk behaviors.
Design, Setting, and Participants


This 12-month longitudinal, 2-group randomized clinical trial recruited MSM through online banner advertisements from March through August 2015. Those recruited were at least 18 years of age, reported engaging in anal sex with men in the past year, never tested positive for HIV, and were US residents with mailing addresses. Participants completed quarterly online surveys. Telephone call notes and laboratory test results were included in the analysis, which was completed from August 2017 through December 2018.
Interventions


All participants had access to online web-based HIV testing resources and telephone counseling on request. Participants were randomized in a 1:1 ratio to the control group or a self-testing (ST) group, which received 4 HIV self-tests after completing the baseline survey with the option to replenish self-tests after completing quarterly surveys. At study completion, all participants were offered 2 self-tests and 1 dried blood spot collection kit.
Main Outcomes and Measures


Primary outcomes were HIV testing frequency (tested ≥3 times during the trial) and number of newly identified HIV infections among participants in both groups and social network members who used the study HIV self-tests. Secondary outcomes included sex behaviors (eg, anal sex, serosorting).
Results


Of 2665 participants, the mean (SD) age was 30 (9.6) years, 1540 (57.8%) were white, and 443 (16.6%) had never tested for HIV before enrollment. Retention rates at each time point were more than 54%, and 1991 (74.7%) participants initiated 1 or more follow-up surveys. More ST participants reported testing 3 or more times during the trial than control participants (777 of 1014 [76.6%] vs 215 of 977 [22.0%]; P < .01). The cumulative number of newly identified infections during the trial was twice as high in the ST participants as the control participants (25 of 1325 [1.9%] vs 11 of 1340 [0.8%]; P = .02), with the largest difference in HIV infections identified in the first 3 months (12 of 1325 [0.9%] vs 2 of 1340 [0.1%]; P < .01). The ST participants reported 34 newly identified infections among social network members who used the self-tests.
Conclusions and Relevance


Distribution of HIV self-tests provides a worthwhile mechanism to increase awareness of HIV infection and prevent transmission among MSM.
Trial Registration


ClinicalTrials.gov identifier: NCT02067039.",2020,"Retention rates at each time point were more than 54%, and 1991 (74.7%) participants initiated 1 or more follow-up surveys.","['the mean (SD) age was 30 (9.6) years, 1540 (57.8%) were white, and 443 (16.6%) had never tested for HIV before enrollment', 'Those recruited were at least 18 years of age, reported engaging in anal sex with men in the past year, never tested positive for HIV, and were US residents with mailing addresses', '2665 participants', 'Men', 'men who have sex with men (MSM', 'All participants had access to online web-based HIV testing resources and telephone counseling on request', 'Who Have Sex With Men']","['Internet-Distributed HIV Self-tests', 'control group or a self-testing (ST']","['HIV Diagnosis and Behavioral Outcomes', 'HIV infections', 'HIV testing frequency (tested ≥3 times during the trial) and number of newly identified HIV infections', 'frequency of testing, diagnoses of HIV infection, and sexual risk behaviors', 'sex behaviors (eg, anal sex, serosorting', 'Retention rates', 'cumulative number of newly identified infections']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0282347', 'cui_str': 'Anal Sex'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0376649', 'cui_str': 'Address'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0019693', 'cui_str': 'T-Lymphotropic Virus Type III Infections, Human'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}, {'cui': 'C0036864', 'cui_str': 'Sexual Behavior'}, {'cui': 'C0282347', 'cui_str': 'Anal Sex'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C3714514', 'cui_str': 'Infection'}]",2665.0,0.11062,"Retention rates at each time point were more than 54%, and 1991 (74.7%) participants initiated 1 or more follow-up surveys.","[{'ForeName': 'Robin J', 'Initials': 'RJ', 'LastName': 'MacGowan', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Pollyanna R', 'Initials': 'PR', 'LastName': 'Chavez', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Craig B', 'Initials': 'CB', 'LastName': 'Borkowf', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'S Michele', 'Initials': 'SM', 'LastName': 'Owen', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Purcell', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Jonathan H', 'Initials': 'JH', 'LastName': 'Mermin', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Patrick S', 'Initials': 'PS', 'LastName': 'Sullivan', 'Affiliation': 'Emory University, Atlanta, Georgia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA internal medicine,['10.1001/jamainternmed.2019.5222']
3663,32151220,Modified Glucose-Insulin-Potassium Regimen Provides Cardioprotection With Improved Tissue Perfusion in Patients Undergoing Cardiopulmonary Bypass Surgery.,"Background Laboratory studies demonstrate glucose-insulin-potassium (GIK) as a potent cardioprotective intervention, but clinical trials have yielded mixed results, likely because of varying formulas and timing of GIK treatment and different clinical settings. This study sought to evaluate the effects of modified GIK regimen given perioperatively with an insulin-glucose ratio of 1:3 in patients undergoing cardiopulmonary bypass surgery. Methods and Results In this prospective, randomized, double-blinded trial with 930 patients referred for cardiac surgery with cardiopulmonary bypass, GIK (200 g/L glucose, 66.7 U/L insulin, and 80 mmol/L KCl) or placebo treatment was administered intravenously at 1 mL/kg per hour 10 minutes before anesthesia and continuously for 12.5 hours. The primary outcome was the incidence of in-hospital major adverse cardiac events including all-cause death, low cardiac output syndrome, acute myocardial infarction, cardiac arrest with successful resuscitation, congestive heart failure, and arrhythmia. GIK therapy reduced the incidence of major adverse cardiac events and enhanced cardiac function recovery without increasing perioperative blood glucose compared with the control group. Mechanistically, this treatment resulted in increased glucose uptake and less lactate excretion calculated by the differences between arterial and coronary sinus, and increased phosphorylation of insulin receptor substrate-1 and protein kinase B in the hearts of GIK-treated patients. Systemic blood lactate was also reduced in GIK-treated patients during cardiopulmonary bypass surgery. Conclusions A modified GIK regimen administered perioperatively reduces the incidence of in-hospital major adverse cardiac events in patients undergoing cardiopulmonary bypass surgery. These benefits are likely a result of enhanced systemic tissue perfusion and improved myocardial metabolism via activation of insulin signaling by GIK. Clinical Trial Registration URL: clinicaltrials.gov. Identifier: NCT01516138.",2020,GIK therapy reduced the incidence of major adverse cardiac events and enhanced cardiac function recovery without increasing perioperative blood glucose compared with the control group.,"['patients undergoing cardiopulmonary bypass surgery', '930 patients referred for cardiac surgery with cardiopulmonary bypass, GIK (200 g/L glucose, 66.7 U/L insulin, and 80 mmol/L KCl) or', 'Patients Undergoing Cardiopulmonary Bypass Surgery']","['GIK therapy', 'placebo', 'Modified Glucose-Insulin-Potassium Regimen Provides Cardioprotection', 'glucose-insulin-potassium (GIK', 'modified GIK regimen']","['Systemic blood lactate', 'incidence of in-hospital major adverse cardiac events including all-cause death, low cardiac output syndrome, acute myocardial infarction, cardiac arrest with successful resuscitation, congestive heart failure, and arrhythmia', 'incidence of in-hospital major adverse cardiac events', 'incidence of major adverse cardiac events', 'glucose uptake and less lactate excretion', 'phosphorylation of insulin receptor substrate-1 and protein kinase B']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007202', 'cui_str': 'Heart-Lung Bypass'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439294', 'cui_str': 'mcg/mcL'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C4517843', 'cui_str': '66.7 (qualifier value)'}, {'cui': 'C0439339', 'cui_str': 'mU/mL'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C1532563', 'cui_str': 'umol/mL'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0304475', 'cui_str': 'Potassium supplement'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0600177', 'cui_str': 'Low Cardiac Output Syndrome'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction (disorder)'}, {'cui': 'C0340514', 'cui_str': 'Cardiac arrest with successful resuscitation (disorder)'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure (disorder)'}, {'cui': 'C0003811', 'cui_str': 'Arrhythmia'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0031715', 'cui_str': 'Phosphorylation'}, {'cui': 'C0123658', 'cui_str': 'Insulin Receptor Substrate-1'}, {'cui': 'C0164786', 'cui_str': 'Proto-Oncogene Proteins c-akt'}]",930.0,0.212401,GIK therapy reduced the incidence of major adverse cardiac events and enhanced cardiac function recovery without increasing perioperative blood glucose compared with the control group.,"[{'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Zhao', 'Affiliation': ""Department of Cardiovascular Surgery Fourth Military Medical University Xi'an, China.""}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Department of Ultrasonic Diagnosis Xijing Hospital Fourth Military Medical University Xi'an, China.""}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ""School of Aerospace Medicine Fourth Military Medical University Xi'an, China.""}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Cui', 'Affiliation': ""Department of Cardiovascular Surgery Fourth Military Medical University Xi'an, China.""}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Zhao', 'Affiliation': ""Department of Cardiovascular Surgery Fourth Military Medical University Xi'an, China.""}, {'ForeName': 'Wensheng', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': ""Department of Cardiovascular Surgery Fourth Military Medical University Xi'an, China.""}, {'ForeName': 'Jincheng', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ""Department of Cardiovascular Surgery Fourth Military Medical University Xi'an, China.""}, {'ForeName': 'Bijun', 'Initials': 'B', 'LastName': 'Zhao', 'Affiliation': ""Department of Cardiovascular Surgery Fourth Military Medical University Xi'an, China.""}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Wan', 'Affiliation': ""Department of Health Statistics and Fourth Military Medical University Xi'an, China.""}, {'ForeName': 'Xin-Liang', 'Initials': 'XL', 'LastName': 'Ma', 'Affiliation': 'Department of Emergency Medicine Thomas Jefferson University Philadelphia PA.'}, {'ForeName': 'Shiqiang', 'Initials': 'S', 'LastName': 'Yu', 'Affiliation': ""Department of Cardiovascular Surgery Fourth Military Medical University Xi'an, China.""}, {'ForeName': 'Dinghua', 'Initials': 'D', 'LastName': 'Yi', 'Affiliation': ""Department of Cardiovascular Surgery Fourth Military Medical University Xi'an, China.""}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Gao', 'Affiliation': ""School of Aerospace Medicine Fourth Military Medical University Xi'an, China.""}]",Journal of the American Heart Association,['10.1161/JAHA.119.012376']
3664,32061834,Online Couple-Based Meditation Intervention for Patients With Primary or Metastatic Brain Tumors and Their Partners: Results of a Pilot Randomized Controlled Trial.,"OBJECTIVES


Although patients with primary and metastatic brain tumors and their partners are at risk of experiencing high symptom burden, they are often excluded from psychosocial intervention studies. Thus, we sought to examine the feasibility and preliminary efficacy of a couple-based meditation (CBM) program targeting symptom and well-being outcomes.
METHODS


Couples completed baseline measures assessing symptom and well-being outcomes and were randomized to the CBM or a usual care control group. Couples in the CBM groups attended four weekly (60 minutes each) therapist-led sessions that were delivered via FaceTime (Apple Inc, Cupertino, CA). The CBM program focused on cultivating mindfulness, compassion, gratitude and purpose, and integrated emotional disclosure exercises. Both groups were reassessed six and 12 weeks after baseline.
RESULTS


We approached 60 eligible dyads, of which 37 (62%) consented, 35 (95%) were randomized, and 22 (63%) completed all assessments. Couples in the CBM group attended a mean of 3.33 sessions (SD 1.09). For patients, significant group differences in favor of the CBM group were found for cognitive (d = 1.05) and general disease symptoms (d = 0.93), and relationship well-being (d = 0.68) and compassion (d = 0.96). No significant group differences were revealed for partners.
CONCLUSION


It seems to be feasible, acceptable, and possibly efficacious to deliver a dyadic intervention via FaceTime to brain tumor couples. Although both patients and partners in the CBM group rated the intervention as beneficial, significant group differences with medium-to-large effect sizes were only found for patients.",2020,"For patients, significant group differences in favor of the CBM group were found for cognitive (d=1.05) and general disease symptoms (d=.93), and relationship well-being (d=.68) and compassion (d=.96).","['60 eligible dyads of which 37 (62%) consented and 35 (95%) were randomized and 22 (63%) completed all assessments', 'Patients with Primary or Metastatic Brain Tumors and their Partners', 'patients with primary and metastatic brain tumors (BT) and their partners']","['CBM or a usual care control (UC', 'CBM', 'couple-based meditation (CBM) program', 'Online Couple-Based Meditation Intervention']","['cultivating mindfulness, compassion, gratitude and purpose and integrated emotional disclosure exercises', 'general disease symptoms']","[{'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0006118', 'cui_str': 'Brain Tumors'}, {'cui': 'C0682323', 'cui_str': 'Companion'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0150277'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C1285529', 'cui_str': 'Purpose (attribute)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0012625', 'cui_str': 'Information Disclosure'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",60.0,0.0473221,"For patients, significant group differences in favor of the CBM group were found for cognitive (d=1.05) and general disease symptoms (d=.93), and relationship well-being (d=.68) and compassion (d=.96).","[{'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Milbury', 'Affiliation': 'Department of Behavioral Science, The University of Texas, MD Anderson Cancer Center, Houston, Texas, USA. Electronic address: kmilbury@mdanderson.org.'}, {'ForeName': 'Shiao-Pei', 'Initials': 'SP', 'LastName': 'Weathers', 'Affiliation': 'Department of Neuro-Oncology, The University of Texas, MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Sania', 'Initials': 'S', 'LastName': 'Durrani', 'Affiliation': 'Department of Behavioral Science, The University of Texas, MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Yisheng', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Biostatistics, The University of Texas, MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Meagan', 'Initials': 'M', 'LastName': 'Whisenant', 'Affiliation': 'Department of Symptom Research, The University of Texas, MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Radiation Oncology, The University of Texas, MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Bora', 'Initials': 'B', 'LastName': 'Lim', 'Affiliation': 'Department of Breast Medical Oncology, The University of Texas, MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Weinberg', 'Affiliation': 'Department of Neurosurgery, The University of Texas, MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Shelli R', 'Initials': 'SR', 'LastName': 'Kesler', 'Affiliation': 'Department of Oncology, Dell Medical School, University of Texas at Austin, Austin, Texas, USA.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Cohen', 'Affiliation': 'Department of Palliative, Rehabilitation & Integrative Medicine, The University of Texas, MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Bruera', 'Affiliation': 'Department of Palliative, Rehabilitation & Integrative Medicine, The University of Texas, MD Anderson Cancer Center, Houston, Texas, USA.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2020.02.004']
3665,31229990,"Prevention of recurrent idiopathic gastroduodenal ulcer bleeding: a double-blind, randomised trial.","OBJECTIVE


Patients with a history of  Helicobacter pylori -negative idiopathic bleeding ulcers have a considerable risk of recurrent ulcer complications. We hypothesised that a proton pump inhibitor (lansoprazole) is superior to a histamine 2 receptor antagonist (famotidine) for the prevention of recurrent ulcer bleeding in such patients.
DESIGN


In this industry-independent, double-blind, randomised trial, we recruited patients with a history of idiopathic bleeding ulcers. After ulcer healing, we randomly assigned (1:1) patients to receive oral lansoprazole 30 mg or famotidine 40 mg daily for 24 months. The primary endpoint was recurrent upper GI bleeding within 24 months, analysed in the intention-to-treat population as determined by an independent adjudication committee.
RESULTS


Between 2010 and 2018, we enrolled 228 patients (114 patients in each study group). Recurrent upper GI bleeding occurred in one patient receiving lansoprazole (duodenal ulcer) and three receiving famotidine (two gastric ulcers and one duodenal ulcer). The cumulative incidence of recurrent upper GI bleeding in 24 months was 0.88% (95% CI 0.08% to 4.37%) in the lansoprazole arm and 2.63% (95% CI 0.71% to 6.91%) in the famotidine arm (p = 0.313; crude HR 0.33, 95% CI 0.03 to 3.16, p = 0.336). None of the patients who rebled used aspirin, non-steroidal anti-inflammatory drugs or other antithrombotic drugs.
CONCLUSION


This 2-year, double-blind randomised trial showed that among patients with a history of  H. pylori -negative idiopathic ulcer bleeding, recurrent bleeding rates were comparable between users of lansoprazole and famotidine, although a small difference in efficacy cannot be excluded.
TRIAL REGISTRATION NUMBER


NCT01180179; Results.",2020,Recurrent upper GI bleeding occurred in one patient receiving lansoprazole (duodenal ulcer) and three receiving famotidine (two gastric ulcers and one duodenal ulcer).,"['recurrent idiopathic gastroduodenal ulcer bleeding', '228 patients (114 patients in each study group', 'patients who rebled used aspirin, non-steroidal anti-inflammatory drugs or other antithrombotic drugs', 'Between 2010 and 2018', 'patients with a history of idiopathic bleeding ulcers', 'After ulcer healing', 'Patients with a history of  Helicobacter pylori -negative idiopathic bleeding ulcers']","['lansoprazole and famotidine', 'oral lansoprazole 30\u2009mg or famotidine', 'lansoprazole', 'proton pump inhibitor (lansoprazole', 'histamine 2 receptor antagonist (famotidine', 'famotidine']","['history of  H. pylori -negative idiopathic ulcer bleeding, recurrent bleeding rates', 'cumulative incidence of recurrent upper GI bleeding', 'Recurrent upper GI bleeding', 'recurrent upper GI bleeding']","[{'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1608429', 'cui_str': 'Idiopathic (IPAH)'}, {'cui': 'C0030920', 'cui_str': 'Gastroduodenal Ulcer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4708785', 'cui_str': 'One hundred and fourteen'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C0003211', 'cui_str': 'Anti Inflammatory Agents, Nonsteroidal'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0333291', 'cui_str': 'Bleeding ulcer (morphologic abnormality)'}]","[{'cui': 'C0050940', 'cui_str': 'lansoprazole'}, {'cui': 'C0015620', 'cui_str': 'Famotidine'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1602204', 'cui_str': 'lansoprazole 30 MG [Prevacid]'}, {'cui': 'C4521480', 'cui_str': 'Hydrogen/potassium adenosine triphosphatase enzyme system inhibitor (disposition)'}, {'cui': 'C0019588', 'cui_str': 'Histamine'}, {'cui': 'C4543207', 'cui_str': 'Receptor antagonist'}]","[{'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C1608429', 'cui_str': 'Idiopathic (IPAH)'}, {'cui': 'C0333291', 'cui_str': 'Bleeding ulcer (morphologic abnormality)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0041909', 'cui_str': 'Upper gastrointestinal hemorrhage (disorder)'}]",228.0,0.331017,Recurrent upper GI bleeding occurred in one patient receiving lansoprazole (duodenal ulcer) and three receiving famotidine (two gastric ulcers and one duodenal ulcer).,"[{'ForeName': 'Grace L H', 'Initials': 'GLH', 'LastName': 'Wong', 'Affiliation': 'Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Louis H S', 'Initials': 'LHS', 'LastName': 'Lau', 'Affiliation': 'Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Jessica Y L', 'Initials': 'JYL', 'LastName': 'Ching', 'Affiliation': 'Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Yee-Kit', 'Initials': 'YK', 'LastName': 'Tse', 'Affiliation': 'Institute of Digestive Diseases, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Rachel H Y', 'Initials': 'RHY', 'LastName': 'Ling', 'Affiliation': 'Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Vincent W S', 'Initials': 'VWS', 'LastName': 'Wong', 'Affiliation': 'Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Philip W Y', 'Initials': 'PWY', 'LastName': 'Chiu', 'Affiliation': 'Department of Surgery, The Chinese University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'James Y W', 'Initials': 'JYW', 'LastName': 'Lau', 'Affiliation': 'Department of Surgery, The Chinese University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Francis K L', 'Initials': 'FKL', 'LastName': 'Chan', 'Affiliation': 'Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong, China.'}]",Gut,['10.1136/gutjnl-2019-318715']
3666,31148534,Long-term effects of psychotherapy in a context of continuous community and gang violence: changes in aggressive attitude in high-risk South African adolescents.,"BACKGROUND


Post-traumatic stress but also aggressive attitudes and behaviour can be found in adolescents living in a context of ongoing community and gang violence in the low-income urban areas of Cape Town, South Africa.
AIMS


We investigated the long-term effects (15-20 months after therapy) of (a) Narrative Exposure Therapy for Forensic Offender Rehabilitation (FORNET) and (b) the cognitive behavioural intervention 'Thinking for a Change' (CBT) on post-traumatic stress disorder (PTSD) and aggression compared with a waiting list.
METHOD


Fifty-four young males participated in the treatment trial, of which 17 completed the FORNET intervention, 11 the CBT intervention, and 26 were on a waiting list. The primary outcome was the change score for the Appetitive Aggression Scale; secondary outcomes were the PTSD Symptom Scale-Interview change scores, and the number of perpetrated violent event types.
RESULTS


The reduction in scores for PTSD that had been observed in FORNET completers at the first follow-up were still significant at the second long-term follow-up (Cohen's d = 0.86). In this treatment arm (FORNET), the scores for appetitive aggression were also significantly reduced (Cohen's d = 1.00). There were no significant changes observed for CBT or for the waiting list.
CONCLUSIONS


The study indicates that FORNET can successfully reduce post-traumatic stress as well as the attraction to violence even for individuals living under conditions of continuous traumatic stress.",2020,The study indicates that FORNET can successfully reduce post-traumatic stress as well as the attraction to violence even for individuals living under conditions of continuous traumatic stress.,"['high-risk South African adolescents', 'Fifty-four young males participated in the treatment trial, of which 17 completed the FORNET intervention, 11 the CBT intervention, and 26 were on a waiting list', 'adolescents living in a context of ongoing community and gang violence in the low-income urban areas of Cape Town, South Africa']","['psychotherapy', ""cognitive behavioural intervention 'Thinking for a Change' (CBT""]","['change score for the Appetitive Aggression Scale', 'PTSD Symptom Scale-Interview change scores, and the number of perpetrated violent event types', 'scores for appetitive aggression']","[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C4517807', 'cui_str': 'Fifty-four'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0449255', 'cui_str': 'Context (attribute)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0453952', 'cui_str': 'Cape (physical object)'}, {'cui': 'C0557750', 'cui_str': 'Towns'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}]","[{'cui': 'C1273567', 'cui_str': 'Psychotherapy (specialty)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0001807', 'cui_str': 'Aggression'}, {'cui': 'C0222045'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0242151', 'cui_str': 'Violent'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}]",54.0,0.0367701,The study indicates that FORNET can successfully reduce post-traumatic stress as well as the attraction to violence even for individuals living under conditions of continuous traumatic stress.,"[{'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Hinsberger', 'Affiliation': 'Department of Psychology, University of Konstanz, Germany.'}, {'ForeName': 'Leon', 'Initials': 'L', 'LastName': 'Holtzhausen', 'Affiliation': 'Department of Social Development, University of Cape Town, South Africa.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Sommer', 'Affiliation': 'Department of Psychology, University of Konstanz, Germany.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Kaminer', 'Affiliation': 'Department of Psychology, University of Cape Town, South Africa.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Elbert', 'Affiliation': 'Department of Psychology, University of Konstanz, Germany.'}, {'ForeName': 'Soraya', 'Initials': 'S', 'LastName': 'Seedat', 'Affiliation': 'Department of Psychiatry, Stellenbosch University, South Africa.'}, {'ForeName': 'Mareike', 'Initials': 'M', 'LastName': 'Augsburger', 'Affiliation': 'Department of Psychology, University of Konstanz, Germany.'}, {'ForeName': 'Maggie', 'Initials': 'M', 'LastName': 'Schauer', 'Affiliation': 'Department of Psychology, University of Konstanz, Germany.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Weierstall', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Medical School Hamburg, Germany.'}]",Behavioural and cognitive psychotherapy,['10.1017/S1352465819000365']
3667,32120378,Moderators in a physical activity intervention for adolescent girls.,"BACKGROUND


The purpose was to explore whether baseline sociodemographic and physical characteristics moderated effects of an intervention on moderate-to-vigorous physical activity (MVPA), percent body fat, body mass index z-score, and cardiorespiratory fitness (CRF) at post intervention, relative to the control condition.
METHODS


A secondary analysis of data from a group randomized trial including 24 schools (12 intervention and 12 control; N = 1519 girls) was conducted. Age, ethnicity, race, socioeconomic status, and pubertal stage were assessed via survey. Height, weight, MVPA (min/h), percent body fat, and CRF were measured. Mixed-effects linear models were performed.
RESULTS


Compared to the control, the intervention increased overweight and obese girls' CRF (b = 0.28, p = 0.049; b = 0.31, p < 0.01, respectively), but not healthy weight girls' CRF (b = 0.04, p = 0.706). Pre- to mid-puberty girls in the intervention group had slightly lower post-intervention MVPA than those in the control (3.04 vs. 3.31, p = 0.055), while late to post-puberty intervention and control girls' post-intervention MVPA was similar (3.12 vs. 3.04, p = 0.542).
CONCLUSIONS


A PA intervention can improve overweight and obese girls' CRF, possibly attenuating their cardiovascular risk. Effective strategies are needed to assist adolescent girls, especially those in pre- to mid-puberty, in maintaining their MVPA after an intervention ends.
IMPACT


Moderators of physical activity intervention effects among adolescent girls are important to identify because the effectiveness of these interventions to date in this population has been limited. This article contributes to the notable gap in knowledge regarding moderators in physical activity interventions involving adolescent girls, particularly baseline characteristics that may moderate their responses to physical activity interventions. Awareness of the moderators can be useful for determining the type of intervention that may be successful in subgroups of adolescent girls and for tailoring a physical activity intervention to optimally meet each girl's needs to achieve maximal effects. Findings show that weight status moderated the intervention effects on cardiorespiratory fitness. Compared to the control condition, the intervention increased overweight and obese, but not healthy weight, girls' cardiorespiratory fitness. A physical activity intervention can improve overweight and obese girls' cardiorespiratory fitness, possibly attenuating their cardiovascular risk. Therefore, it is essential to include overweight and obese girls in PA interventions to help them reap this important benefit.",2020,"Compared to the control, the intervention increased overweight and obese girls' CRF (F = 4.36, p = 0.037; F = 6.56, p = 0.011, respectively), but not healthy weight girls' CRF (F = 0.01, p = 0.925).","['adolescent girls', '24 schools (12 intervention and 12 control; N\u2009=\u20091519 girls']","['physical activity intervention', 'PA intervention']","['Height, weight, MVPA (min/h), percent body fat, and CRF', 'cardiorespiratory fitness', 'moderate-to-vigorous physical activity (MVPA), percent body fat, body mass index z-score, and cardiorespiratory fitness (CRF', ""overweight and obese girls' CRF""]","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C0010132', 'cui_str': 'corticorelin'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]",1519.0,0.0162252,"Compared to the control, the intervention increased overweight and obese girls' CRF (F = 4.36, p = 0.037; F = 6.56, p = 0.011, respectively), but not healthy weight girls' CRF (F = 0.01, p = 0.925).","[{'ForeName': 'Lorraine B', 'Initials': 'LB', 'LastName': 'Robbins', 'Affiliation': 'College of Nursing, Michigan State University, East Lansing, MI, USA. robbin76@msu.edu.'}, {'ForeName': 'Jiying', 'Initials': 'J', 'LastName': 'Ling', 'Affiliation': 'College of Nursing, Michigan State University, East Lansing, MI, USA.'}, {'ForeName': 'Fujun', 'Initials': 'F', 'LastName': 'Wen', 'Affiliation': 'Center for Family Health, 505 N Jackson St, Jackson, MI, USA.'}]",Pediatric research,['10.1038/s41390-020-0818-5']
3668,31268629,Resolute zotarolimus-eluting stent in ST-elevation myocardial infarction (resolute-STEMI): A prespecified prospective register from the DAPT-STEMI trial.,"OBJECTIVES


To evaluate the safety and efficacy outcomes after primary percutaneous coronary intervention (pPCI) with second-generation Resolute™ zotarolimus-eluting stent (R-ZES) in patients enrolled in the DAPT-STEMI Trial (NCT01459627).
BACKGROUND


R-ZES is one of the most used drug eluting stents worldwide. To date, the safety and efficacy data of this stent in setting of STEMI is limited.
METHODS


The Resolute-STEMI is a prespecified prospective register that reports the safety and efficacy of R-ZES in setting of ST-Elevation Myocardial Infarction (STEMI) at 6 months for the following endpoints: a composite endpoint of all-cause mortality, any myocardial infarction (MI), any (unscheduled) revascularization, stroke and TIMI major bleeding, as well as target lesion failure and stent thrombosis (ST).
RESULTS


From a total of 1,100 STEMI patients enrolled in the trial, 998 received a R-ZES. At 6 months the PE occurred in 42 (4.2%) patients. All-cause death, MI, revascularization, stroke and TIMI major bleeding was respectively 8 (0.8%), 9 (0.8%), 34 (3.4%), 2 (0.2%), and 4 (0.4%). The rate of target lesion revascularizations involving the culprit lesion was 1.1%. Target lesion failure was 1.5%. The rate of definite ST was 0.5%. The rate of both definite or probable ST was 0.7%.
CONCLUSIONS


The present analysis is the largest to date reporting short-term and mid-term clinical outcomes with the R-ZES stent in setting of STEMI. At 30 days and 6-months R-ZES has an outstanding safety and efficacy even in this high-risk category of patients.",2020,"All-cause death, MI, revascularization, stroke and TIMI major bleeding was respectively 8 (0.8%), 9 (0.8%), 34 (3.4%), 2 (0.2%), and 4 (0.4%).","['patients enrolled in the DAPT-STEMI Trial (NCT01459627', 'From a total of 1,100 STEMI patients enrolled in the trial, 998 received a R-ZES']","['Resolute zotarolimus-eluting stent', 'primary percutaneous coronary intervention (pPCI) with second-generation Resolute™ zotarolimus-eluting stent (R-ZES']","['PE', 'safety and efficacy outcomes', 'rate of definite ST', 'rate of target lesion revascularizations', 'myocardial infarction (MI), any (unscheduled) revascularization, stroke and TIMI major bleeding, as well as target lesion failure and stent thrombosis (ST', 'All-cause death, MI, revascularization, stroke and TIMI major bleeding', 'rate of both definite or probable ST', 'Target lesion failure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1536220', 'cui_str': 'ST Elevated Myocardial Infarction'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]","[{'cui': 'C1700035', 'cui_str': 'zotarilumus'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0079411', 'cui_str': 'Generations'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439544', 'cui_str': 'Definite (qualifier value)'}, {'cui': 'C0014742', 'cui_str': 'Erythema Multiforme'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}]",1100.0,0.0478449,"All-cause death, MI, revascularization, stroke and TIMI major bleeding was respectively 8 (0.8%), 9 (0.8%), 34 (3.4%), 2 (0.2%), and 4 (0.4%).","[{'ForeName': 'Warner', 'Initials': 'W', 'LastName': 'Postma', 'Affiliation': 'Isala Hartcentrum, Zwolle, the Netherlands.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Fabris', 'Affiliation': 'Isala Hartcentrum, Zwolle, the Netherlands.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Van der Ent', 'Affiliation': 'Maasstad Ziekenhuis, Rotterdam, the Netherlands.'}, {'ForeName': 'Rik', 'Initials': 'R', 'LastName': 'Hermanides', 'Affiliation': 'Isala Hartcentrum, Zwolle, the Netherlands.'}, {'ForeName': 'Pawel', 'Initials': 'P', 'LastName': 'Buszman', 'Affiliation': 'American Heart of Poland, Ustroń, Poland.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Von Birgelen C', 'Affiliation': 'Thoraxcenter, Erasmus Medisch Centrum, Rotterdam, the Netherlands.'}, {'ForeName': 'Stephane', 'Initials': 'S', 'LastName': 'Cook', 'Affiliation': 'Department of Cardiology, University and Hospital, Fribourg, Switzerland.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Wedel', 'Affiliation': 'Sahlgrenska Academy, University of Gothenburg and Nordic School of Public Health, Gothenburg, Sweden.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'De Luca', 'Affiliation': 'Department of Cardiology, Eastern Piedmont University, Novara, Italy.'}, {'ForeName': 'Ronak', 'Initials': 'R', 'LastName': 'Delewi', 'Affiliation': 'Heart Centre, Academic Medical Centre, University Medical Center Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Zijlstra', 'Affiliation': 'Thoraxcenter, Erasmus Medisch Centrum, Rotterdam, the Netherlands.'}, {'ForeName': 'Elvin', 'Initials': 'E', 'LastName': 'Kedhi', 'Affiliation': 'Isala Hartcentrum, Zwolle, the Netherlands.'}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.28376']
3669,31621838,Antiretroviral Therapy-Induced Bone Loss Is Durably Suppressed by a Single Dose of Zoledronic Acid in Treatment-Naive Persons with Human Immunodeficiency Virus Infection: A Phase IIB Trial.,"BACKGROUND


Human immunodeficiency virus (HIV) infection and antiretroviral therapy (ART) are associated with bone loss leading to increased fracture rate among persons with HIV (PWH). We previously showed long-acting antiresorptive zoledronic acid (ZOL) prevented ART-induced bone loss through 48 weeks of therapy and here investigate whether protection persisted.
METHODS


We randomized 63 nonosteoporotic, treatment-naive adult PWH initiating ART to ZOL (5 mg) versus placebo in a double-blinded, placebo-controlled, phase IIb trial. Here we analyzed the long-term outcome data (144 weeks). Plasma bone turnover markers and bone mineral density (BMD) were quantified at weeks 0, 12, 24, 48, 96, and 144. Primary outcome was change in bone resorption marker C-terminal telopeptide of collagen (CTx). Repeated-measures analyses using mixed linear models were used to estimate and compare study endpoints.
RESULTS


At 96 weeks, mean CTx was 62% lower with ZOL relative to placebo (n = 46; CTx = 0.123 vs 0.324 ng/mL; P < .001); at 144 weeks a 25% difference between arms was not statistically significant. At 48 weeks, lumbar spine BMD with ZOL was 11% higher than placebo (n = 60; P < .001) and remained 9-11% higher at 96 (n = 46) and 144 (n = 41; P < .001) weeks. 144 weeks after ZOL infusion, BMD did not change at the lumbar spine (P = .22) but declined at the hip (P = .04) and femoral neck (P = .02).
CONCLUSIONS


A single dose of ZOL administered at ART initiation blunts bone resorption and BMD loss at key fracture-prone anatomical sites in treatment-naive PWH for 3 years. A multicenter randomized phase III clinical trial validating these results in a larger population is needed.
CLINICAL TRIALS REGISTRATION


NCT01228318.",2020,"At 96 weeks, mean CTx was 62% lower with ZOL relative to placebo (n=46; CTx=0.123 vs. 0.324 ng/mL; p<0.001); at 144 weeks a 25% difference between arms was not statistically significant.",['persons with HIV (PWH'],"['antiresorptive zoledronic acid (ZOL', 'ZOL', 'placebo', 'Zoledronic Acid', 'antiretroviral therapy (ART']","['Plasma bone turnover markers and bone mineral density (BMD', 'lumbar spine BMD', 'mean CTx', 'femoral neck', 'lumbar spine', 'bone resorption and BMD loss', 'bone resorption marker C-terminal telopeptide of collagen (CTx']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}]","[{'cui': 'C0257685', 'cui_str': 'zoledronic acid'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0003826', 'cui_str': 'Arts'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0085268', 'cui_str': 'Bone Turnover'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C3887615', 'cui_str': 'Lumbar spine structure (body structure)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0015815', 'cui_str': 'Femoral Neck'}, {'cui': 'C0005974', 'cui_str': 'Osteoclastic Bone Loss'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}]",63.0,0.676076,"At 96 weeks, mean CTx was 62% lower with ZOL relative to placebo (n=46; CTx=0.123 vs. 0.324 ng/mL; p<0.001); at 144 weeks a 25% difference between arms was not statistically significant.","[{'ForeName': 'Ighovwerha', 'Initials': 'I', 'LastName': 'Ofotokun', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Lauren F', 'Initials': 'LF', 'LastName': 'Collins', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Kehmia', 'Initials': 'K', 'LastName': 'Titanji', 'Affiliation': 'Division of Endocrinology and Metabolism and Lipids, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Antonina', 'Initials': 'A', 'LastName': 'Foster', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Caitlin A', 'Initials': 'CA', 'LastName': 'Moran', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Anandi N', 'Initials': 'AN', 'LastName': 'Sheth', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Cecile D', 'Initials': 'CD', 'LastName': 'Lahiri', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Lennox', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Ward', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'Kirk A', 'Initials': 'KA', 'LastName': 'Easley', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'M Neale', 'Initials': 'MN', 'LastName': 'Weitzmann', 'Affiliation': 'Division of Endocrinology and Metabolism and Lipids, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz1027']
3670,31846067,Randomized clinical trial of intracorporeal versus extracorporeal anastomosis in laparoscopic right colectomy (IEA trial).,"BACKGROUND


Several non-randomized and retrospective studies have suggested that intracorporeal anastomosis (IA) has advantages over extracorporeal anastomosis (EA) in laparoscopic right colectomy, but scientific evidence is lacking. The aim was to compare short-term outcomes and to define the possible benefits of IA compared with EA in elective laparoscopic right colectomy.
METHODS


An RCT was conducted from May 2015 to June 2018. The primary endpoint was duration of hospital stay. Secondary endpoints were intraoperative technical events and postoperative clinical outcomes.
RESULTS


A total of 140 patients were randomized. Duration of surgery was longer for procedures with an IA than in those with an EA (median 149 (range 95-215) versus 123 (60-240) min; P < 0·001). Wound length was shorter in the IA group (median 6·7 (4-9·5) versus 8·7 (5-13) cm; P < 0·001). Digestive function recovered earlier in patients with an IA (median 2·3 versus 3·3 days; P = 0·003) and the incidence of paralytic ileus was lower (13 versus 30 per cent; P = 0·022). Less postoperative analgesia was needed in the IA group (mean(s.d.) weighted analgesia requirement 39(24) versus 53(26); P = 0·001) and the pain score was also lower (P = 0·035). The postoperative decrease in haemoglobin level was smaller (mean(s.d.) 8·8(1·7) versus 17·1(1·7) mg/dl; P = 0·001) and there was less lower gastrointestinal bleeding (3 versus 14 per cent; P = 0·031) in the IA group. IA was associated with a significantly better rate of grade I and II complications (P = 0·016 and P = 0·037 respectively). The duration of hospital stay was slightly shorter in the IA group (median 5·7 (range 2-19) versus 6·6 (2-23) days; P = 0·194).
CONCLUSION


Duration of hospital stay was similar, but IA was associated with less pain and fewer complications. Registration number: NCT02667860 ( http://www.clinicaltrials.gov).",2020,IA was associated with a significantly better rate of grade I and II complications (P = 0·016 and P = 0·037 respectively).,"['elective laparoscopic right colectomy', '140 patients were randomized']","['extracorporeal anastomosis (EA', 'intracorporeal anastomosis (IA', 'EA', '17·1(1·7) mg/dl', 'intracorporeal versus extracorporeal anastomosis']","['haemoglobin level', 'pain score', 'Wound length', 'gastrointestinal bleeding', 'pain and fewer complications', 'postoperative analgesia', 'rate of grade I and II complications', 'Digestive function', 'duration of hospital stay', 'hospital stay', 'incidence of paralytic ileus', 'intraoperative technical events and postoperative clinical outcomes', 'Duration of surgery']","[{'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0192861', 'cui_str': 'Right colectomy (procedure)'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0442087', 'cui_str': 'Extracorporeal (qualifier value)'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis (morphologic abnormality)'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0017181', 'cui_str': 'Gastrointestinal Hemorrhage'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205388', 'cui_str': 'Few (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0030446', 'cui_str': 'Paralytic Ileus'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]",140.0,0.370699,IA was associated with a significantly better rate of grade I and II complications (P = 0·016 and P = 0·037 respectively).,"[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bollo', 'Affiliation': 'Department of Surgery, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Turrado', 'Affiliation': 'Department of Surgery, Hospital Clinic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Rabal', 'Affiliation': 'Department of Surgery, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Carrillo', 'Affiliation': ""Department of Medicine, Hospital Vall d'Hebron, Autonomous University of Barcelona, Barcelona, Spain.""}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Gich', 'Affiliation': 'Department of Clinical Epidemiology and Public Health, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.'}, {'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'Martinez', 'Affiliation': 'Department of Surgery, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Hernandez', 'Affiliation': 'Department of Surgery, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Targarona', 'Affiliation': 'Department of Surgery, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.'}]",The British journal of surgery,['10.1002/bjs.11389']
3671,32088296,"Effects of Colesevelam on Bowel Symptoms, Biomarkers, and Colonic Mucosal Gene Expression in Patients With Bile Acid Diarrhea in a Randomized Trial.","BACKGROUND & AIMS


Approximately one-third of patients with IBS-diarrhea (IBS-D) have increased bile acid (BA) synthesis or excretion. An open-label study showed benefits of colesevelam on bowel functions, consistent with luminal BA sequestration by colesevelam. We compared the effects of colesevelam vs placebo on symptoms and gene expression patterns in the sigmoid colon mucosa in patients with BA diarrhea associated with IBS-D.
METHODS


We performed a double-blind, parallel-group study of 30 adults with IBS-D and evidence of increased BA synthesis or fecal excretion, from December 2017 through December 2018 at a single center. Patients were randomly assigned (1:1) to groups given colesevelam (3 tablets, 625 mg each) or matching placebo, orally twice daily for 4 weeks. Stool diaries documented bowel functions for 8 days before and 28 days during colesevelam or placebo. Stool and fasting serum samples were collected for analyses of fecal BAs and serum levels of C4 and FGF19. We measured colonic transit by scintigraphy, mucosal permeability by in vivo excretion of saccharide probes, and mRNA levels in rectosigmoid biopsies. All measurements were made at baseline and on the last days of treatment. The primary endpoints were change in total fecal BA concentration and stool consistency.
RESULTS


Compared with placebo, colesevelam was associated with significant changes in sequestered fecal total BA excretion (P < .001) and serum levels of C4 and FGF19 (both P < .001), and with a mean increase in fecal level of deoxycholic acid (10%; P = .07) compared to placebo. Colesevelam decreased colon mucosal expression of NR1H4 and P2RY4 and increased expression of GPBAR1, compared with baseline. Stool frequency and consistency, colonic transit, and permeability did not differ significantly between groups. Colesevelam was well tolerated.
CONCLUSIONS


In a randomized trial, we found that colesevelam increases delivery of total and secondary BAs to stool, hepatic BA synthesis, and colonic mucosal expression of genes that regulate BA, farnesoid X, and GPBAR1 receptors. Larger studies are needed to determine the effects on clinical responses. ClinicalTrials.gov no: NCT03270085.",2020,"Colesevelam decreased colon mucosal expression of NR1H4 and P2RY4 and increased expression of GPBAR1, compared with baseline.","['Patients with Bile Acid Diarrhea', '30 adults with IBS-D and evidence of increased BA synthesis or fecal excretion, from December 2017 through December 2018 at a single center', 'patients with BA diarrhea associated with IBS-D']","['Colesevelam', 'colesevelam vs placebo', 'placebo', 'colesevelam (3 tablets, 625 mg each) or matching placebo']","['delivery of total and secondary BAs to stool, hepatic BA synthesis, and colonic mucosal expression of genes that regulate BA, farnesoid X, and GPBAR1 receptors', 'colonic transit by scintigraphy, mucosal permeability by in vivo excretion of saccharide probes, and mRNA levels', 'Stool frequency and consistency, colonic transit, and permeability', 'tolerated', 'bile acid (BA) synthesis or excretion', 'total fecal BA concentration and stool consistency', 'sequestered fecal total BA excretion (P<.001) and serum levels of C4 and FGF19', 'Stool and fasting serum samples', 'Bowel Symptoms, Biomarkers, and Colonic Mucosal Gene Expression', 'colon mucosal expression of NR1H4 and P2RY4 and increased expression of GPBAR1', 'fecal level of deoxycholic acid', 'fecal BAs and serum levels of C4 and FGF19']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4524087', 'cui_str': 'Bile acid diarrhea'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332120', 'cui_str': 'Evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}]","[{'cui': 'C0541155', 'cui_str': 'colesevelam'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C4517838', 'cui_str': 'Six hundred and twenty-five'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0009368', 'cui_str': 'Colon'}, {'cui': 'C0026724', 'cui_str': 'Mucosal Tissue'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C0034606', 'cui_str': 'Gamma Camera Imaging'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0007004', 'cui_str': 'Carbohydrates'}, {'cui': 'C3179165', 'cui_str': 'Probe (methazole)'}, {'cui': 'C0035696', 'cui_str': 'mRNA'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0332529', 'cui_str': 'Consistency finding'}, {'cui': 'C0005390', 'cui_str': 'Bile Acids'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C1550100', 'cui_str': 'Serum specimen'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0017262', 'cui_str': 'Gene Expression'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0011479', 'cui_str': 'Deoxycholic Acid'}]",30.0,0.381983,"Colesevelam decreased colon mucosal expression of NR1H4 and P2RY4 and increased expression of GPBAR1, compared with baseline.","[{'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Vijayvargiya', 'Affiliation': 'Division of Gastroenterology and Hepatology, Clinical Enteric Neuroscience Translational and Epidemiological Research, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Camilleri', 'Affiliation': 'Division of Gastroenterology and Hepatology, Clinical Enteric Neuroscience Translational and Epidemiological Research, Mayo Clinic, Rochester, Minnesota. Electronic address: camilleri.michael@mayo.edu.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Carlson', 'Affiliation': 'Division of Gastroenterology and Hepatology, Clinical Enteric Neuroscience Translational and Epidemiological Research, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Asha', 'Initials': 'A', 'LastName': 'Nair', 'Affiliation': 'Division of Gastroenterology and Hepatology, Clinical Enteric Neuroscience Translational and Epidemiological Research, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Sara Linker', 'Initials': 'SL', 'LastName': 'Nord', 'Affiliation': 'Division of Gastroenterology and Hepatology, Clinical Enteric Neuroscience Translational and Epidemiological Research, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Ryks', 'Affiliation': 'Division of Gastroenterology and Hepatology, Clinical Enteric Neuroscience Translational and Epidemiological Research, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Rhoten', 'Affiliation': 'Division of Gastroenterology and Hepatology, Clinical Enteric Neuroscience Translational and Epidemiological Research, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Duane', 'Initials': 'D', 'LastName': 'Burton', 'Affiliation': 'Division of Gastroenterology and Hepatology, Clinical Enteric Neuroscience Translational and Epidemiological Research, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Busciglio', 'Affiliation': 'Division of Gastroenterology and Hepatology, Clinical Enteric Neuroscience Translational and Epidemiological Research, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Lueke', 'Affiliation': 'Division of Biomedical Statistics and Informatics, Department of Health Sciences Research, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'W Scott', 'Initials': 'WS', 'LastName': 'Harmsen', 'Affiliation': 'Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Leslie J', 'Initials': 'LJ', 'LastName': 'Donato', 'Affiliation': 'Division of Biomedical Statistics and Informatics, Department of Health Sciences Research, Mayo Clinic, Rochester, Minnesota.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2020.02.027']
3672,32078787,New Nutraceutical Combination Reduces Blood Pressure and Improves Exercise Capacity in Hypertensive Patients Via a Nitric Oxide-Dependent Mechanism.,"Background High blood pressure (BP) has long been recognized as a major health threat and, particularly, a major risk factor for stroke, cardiovascular disease, and end-organ damage. However, the identification of a novel, alternative, integrative approach for the control of BP and cardiovascular protection is still needed. Methods and Results Sixty-nine uncontrolled hypertension patients, aged 40 to 68 years, on antihypertensive medication were enrolled in 2 double-blind studies. Forty-five were randomized to placebo or a new nutraceutical combination named AkP05, and BP, endothelial function, and circulating nitric oxide were assessed before and at the end of 4 weeks of treatment. Twenty-four patients were randomized to diuretic or AkP05 for 4 weeks and underwent a cardiopulmonary exercise test to evaluate the effects of AkP05 on functional capacity of the cardiovascular, pulmonary, and muscular systems. Vascular and molecular studies were undertaken on mice to characterize the action of the single compounds contained in the AkP05 nutraceutical combination. AkP05 supplementation reduced BP, improved endothelial function, and increased nitric oxide release; cardiopulmonary exercise test revealed that AkP05 increased maximum O 2  uptake, stress tolerance, and maximal power output. In mice, AkP05 reduced BP and improved endothelial function, evoking increased nitric oxide release through the PKCα/Akt/endothelial nitric oxide synthase pathway and reducing reactive oxygen species production via NADPH-oxidase inhibition. These effects were mediated by synergism of the single compounds of AkP05. Conclusions This is the first study reporting positive effects of a nutraceutical combination on the vasculature and exercise tolerance in treated hypertensive patients. Our findings suggest that AkP05 may be used as an adjunct for the improvement of cardiovascular protection and to better control BP in uncontrolled hypertension.",2020,"AkP05 supplementation reduced BP, improved endothelial function, and increased nitric oxide release; cardiopulmonary exercise test revealed that AkP05 increased maximum O 2  uptake, stress tolerance, and maximal power output.","['Sixty-nine uncontrolled hypertension patients, aged 40 to 68\xa0years, on antihypertensive medication were enrolled in 2 double-blind studies', 'Hypertensive Patients', 'Forty-five were randomized to', 'treated hypertensive patients']","['cardiopulmonary exercise test', 'placebo', 'diuretic or AkP05', ' High blood pressure (BP', 'nutraceutical combination']","['BP and improved endothelial function', 'Blood Pressure and Improves Exercise Capacity', 'maximum O 2  uptake, stress tolerance, and maximal power output', 'BP, endothelial function, and circulating nitric oxide', 'vasculature and exercise tolerance', 'BP, improved endothelial function']","[{'cui': 'C0450388', 'cui_str': '69 (qualifier value)'}, {'cui': 'C1868885', 'cui_str': 'Uncontrolled hypertension'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0003364', 'cui_str': 'Anti-Hypertensive Drugs'}, {'cui': 'C0013072', 'cui_str': 'Double-Masked Method'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C2959886', 'cui_str': 'Cardiopulmonary Exercise Test'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0012798', 'cui_str': 'Diuretics'}, {'cui': 'C0020538', 'cui_str': 'Blood Pressure, High'}, {'cui': 'C1518478', 'cui_str': 'Nutraceuticals'}]","[{'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0520943', 'cui_str': 'Stress tolerance'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0445194', 'cui_str': 'Power output (qualifier value)'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0005839', 'cui_str': 'vasculature'}, {'cui': 'C0162521', 'cui_str': 'Exercise Tolerance'}]",69.0,0.118934,"AkP05 supplementation reduced BP, improved endothelial function, and increased nitric oxide release; cardiopulmonary exercise test revealed that AkP05 increased maximum O 2  uptake, stress tolerance, and maximal power output.","[{'ForeName': 'Albino', 'Initials': 'A', 'LastName': 'Carrizzo', 'Affiliation': 'IRCCS Neuromed Pozzilli Italy.'}, {'ForeName': 'Ornella', 'Initials': 'O', 'LastName': 'Moltedo', 'Affiliation': 'Department of Pharmacy University of Salerno Fisciano Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Damato', 'Affiliation': 'IRCCS Neuromed Pozzilli Italy.'}, {'ForeName': 'Katiuscia', 'Initials': 'K', 'LastName': 'Martinello', 'Affiliation': 'IRCCS Neuromed Pozzilli Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Di Pietro', 'Affiliation': 'Department of Medicine and Surgery University of Salerno Baronissi Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Oliveti', 'Affiliation': 'Department of Medicine and Surgery University of Salerno Baronissi Italy.'}, {'ForeName': 'Fausto', 'Initials': 'F', 'LastName': 'Acernese', 'Affiliation': 'Department of Pharmacy University of Salerno Fisciano Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Giugliano', 'Affiliation': 'Department of Advanced Biomedical Sciences University Federico II of Naples Italy.'}, {'ForeName': 'Raffaele', 'Initials': 'R', 'LastName': 'Izzo', 'Affiliation': 'Department of Advanced Biomedical Sciences University Federico II of Naples Italy.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Sommella', 'Affiliation': 'Department of Pharmacy University of Salerno Fisciano Italy.'}, {'ForeName': 'Serena', 'Initials': 'S', 'LastName': 'Migliarino', 'Affiliation': 'Department of Clinical and Molecular Medicine School of Medicine and Psychology Sapienza University of Rome Italy.'}, {'ForeName': 'Ornella', 'Initials': 'O', 'LastName': 'Piazza', 'Affiliation': 'Department of Medicine and Surgery University of Salerno Baronissi Italy.'}, {'ForeName': 'Carmine', 'Initials': 'C', 'LastName': 'Izzo', 'Affiliation': 'Department of Medicine and Surgery University of Salerno Baronissi Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Virtuoso', 'Affiliation': 'Department of Cardiovascular Medicine A.O.U. Federico II Naples Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Strianese', 'Affiliation': 'Department of Medicine and Surgery University of Salerno Baronissi Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Trimarco', 'Affiliation': 'Department of Advanced Biomedical Sciences Federico II University Hospital Naples Italy.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Campiglia', 'Affiliation': 'Department of Pharmacy University of Salerno Fisciano Italy.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Fucile', 'Affiliation': 'IRCCS Neuromed Pozzilli Italy.'}, {'ForeName': 'Annibale', 'Initials': 'A', 'LastName': 'Puca', 'Affiliation': 'Department of Medicine and Surgery University of Salerno Baronissi Italy.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Trimarco', 'Affiliation': 'Department of Advanced Biomedical Sciences University Federico II of Naples Italy.'}, {'ForeName': 'Carmine', 'Initials': 'C', 'LastName': 'Vecchione', 'Affiliation': 'IRCCS Neuromed Pozzilli Italy.'}]",Journal of the American Heart Association,['10.1161/JAHA.119.014923']
3673,31725105,Cognitive Effects of a Ketogenic Diet on Neurocognitive Impairment in Adults Aging With HIV: A Pilot Study.,"We assessed a ketogenic diet (KD) intervention protocol and the cognitive effects of KD in older adults with HIV-associated neurocognitive impairment. Adults older than 50 years and living with HIV and mild-to-moderate neurocognitive impairment were randomized to either a KD or a patient-choice diet for 12 weeks followed by a 6-week washout period. A neurocognitive battery was administered at baseline, Week 12, and Week 18. Paired t tests compared groups at baseline, and multivariate analyses of covariance were used to assess between-group differences on primary outcome variables at Weeks 12 and 18. We enrolled 17 participants, and 14 completed the study. No between-group baseline differences were noted. The KD group demonstrated improved executive function and speed of processing at Week 12, which were negated after participants resumed their usual diets. Our study supports the potential efficacy of a KD for the treatment of HIV-associated neurocognitive impairment.",2020,"The KD group demonstrated improved executive function and speed of processing at Week 12, which were negated after participants resumed their usual diets.","['Adults Aging With HIV', 'Adults older than 50 years and living with HIV and mild-to-moderate neurocognitive impairment', 'HIV-associated neurocognitive impairment', 'older adults with HIV-associated neurocognitive impairment', 'We enrolled 17 participants, and 14 completed the study']","['KD or a patient-choice diet', 'ketogenic diet (KD) intervention protocol', 'KD', 'Ketogenic Diet']","['Neurocognitive Impairment', 'executive function and speed of processing']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0259972', 'cui_str': 'Ketogenic Diet'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}]",17.0,0.0596428,"The KD group demonstrated improved executive function and speed of processing at Week 12, which were negated after participants resumed their usual diets.","[{'ForeName': 'Shannon A', 'Initials': 'SA', 'LastName': 'Morrison', 'Affiliation': ''}, {'ForeName': 'Pariya L', 'Initials': 'PL', 'LastName': 'Fazeli', 'Affiliation': ''}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Gower', 'Affiliation': ''}, {'ForeName': 'Amanda L', 'Initials': 'AL', 'LastName': 'Willig', 'Affiliation': ''}, {'ForeName': 'Jarred', 'Initials': 'J', 'LastName': 'Younger', 'Affiliation': ''}, {'ForeName': 'N Markie', 'Initials': 'NM', 'LastName': 'Sneed', 'Affiliation': ''}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Vance', 'Affiliation': ''}]",The Journal of the Association of Nurses in AIDS Care : JANAC,['10.1097/JNC.0000000000000110']
3674,31614214,Telephone interventions for co-morbid insomnia and osteoarthritis pain: The OsteoArthritis and Therapy for Sleep (OATS) randomized trial design.,"The OsteoArthritis and Therapy for Sleep (OATS) study is a population-based randomized controlled trial of cognitive behavioral therapy for insomnia (CBTI) with four innovative methodological aims. These are to: (1) Enroll representative participants across Washington state, including those from medically underserved communities; (2) Enroll persons with persistent insomnia and chronic osteoarthritis (OA) pain; (3) Test a scalable CBT-I intervention; and (4) Evaluate patient-reported outcomes (insomnia, pain severity, fatigue, depression) and cost-effectiveness over one year. This paper describes progress towards achieving these aims. The target population was persons age 60+ who had received OA care within the Kaiser Permanente Washington (KPW) health care system. We employed a two-phase screening via mail survey and telephone follow-up, with a 3-week interval between screens to exclude persons with spontaneous improvement in sleep or pain symptoms. Participants were randomized to a 6-session telephone-delivered CBT-I intervention or a 6-session telephone education only control condition (EOC). Blinded outcome assessments (completed online or on mailed paper forms) included primary and secondary sleep and pain outcome measures and quality of life measures. We obtained healthcare utilization from administrative claims data. Intent to treat analyses, including all participants randomized when they scheduled the first telephone session, will be conducted to compare CBT-I and EOC outcomes. The trial will be the largest experimental evaluation of telephone CBT-I to date, and the first to evaluate its cost-effectiveness. Trial registration: ClinicalTrials.gov identifier: NCT02946957.",2019,Participants were randomized to a 6-session telephone-delivered CBT-I intervention or a 6-session telephone education only control condition (EOC).,"['co-morbid insomnia and osteoarthritis pain', 'Enroll representative participants across Washington state, including those from medically underserved communities; (2) Enroll persons with persistent insomnia and chronic osteoarthritis (OA) pain; (3', 'target population was persons age 60+ who had received OA care within the Kaiser Permanente Washington (KPW) health care system']","['6-session telephone-delivered CBT-I intervention or a 6-session telephone education only control condition (EOC', 'Telephone interventions', 'cognitive behavioral therapy']","['primary and secondary sleep and pain outcome measures and quality of life measures', 'sleep or pain symptoms', 'outcomes (insomnia, pain severity, fatigue, depression) and cost-effectiveness']","[{'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0043038', 'cui_str': 'Washington'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0393758', 'cui_str': 'Persistent insomnia (disorder)'}, {'cui': 'C0263778', 'cui_str': 'Chronic osteoarthritis (disorder)'}, {'cui': 'C0039309', 'cui_str': 'Target Population'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0018696', 'cui_str': 'Health Care Systems'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0034380'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.0977968,Participants were randomized to a 6-session telephone-delivered CBT-I intervention or a 6-session telephone education only control condition (EOC).,"[{'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'McCurry', 'Affiliation': 'Department of Child, Family, and Population Health Nursing, University of Washington School of Nursing, Seattle, WA, United States of America. Electronic address: smccurry@uw.edu.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Von Korff', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, WA, United States of America.'}, {'ForeName': 'Charles M', 'Initials': 'CM', 'LastName': 'Morin', 'Affiliation': 'Department of Psychology, Université Laval, Quebec City, Quebec, Canada.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Cunningham', 'Affiliation': 'Department of Child, Family, and Population Health Nursing, University of Washington School of Nursing, Seattle, WA, United States of America.'}, {'ForeName': 'Kenneth C', 'Initials': 'KC', 'LastName': 'Pike', 'Affiliation': 'Department of Child, Family, and Population Health Nursing, University of Washington School of Nursing, Seattle, WA, United States of America.'}, {'ForeName': 'Manu', 'Initials': 'M', 'LastName': 'Thakral', 'Affiliation': 'Department of Nursing, University of Massachusetts Boston, Boston, MA, United States of America.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Wellman', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, WA, United States of America.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Yeung', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, WA, United States of America.'}, {'ForeName': 'Weiwei', 'Initials': 'W', 'LastName': 'Zhu', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, WA, United States of America.'}, {'ForeName': 'Michael V', 'Initials': 'MV', 'LastName': 'Vitiello', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, University of Washington School of Medicine, Seattle, WA, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105851']
3675,15029102,Repaglinide is more efficient than glimepiride on insulin secretion and post-prandial glucose excursions in patients with type 2 diabetes. A short term study.,"OBJECTIVES


To compare the effect of Repaglinide vs Glimepiride on glucose- and meal-induced insulin secretion and on meal-test induced postprandial glucose excursions.
METHODS


After 2 weeks washout period, a 3-Month randomised, cross-over parallel group trial of R (1 mg x 2/die) vs G (2 mg/die) in 14 patients with type 2 diabetes ""naive"" in diet treatment was made.
RESULTS


Both R and G significantly but similarly lowered fasting glucose levels and improved fasting plasma insulin levels vs baseline. Hyperglycemic clamp showed that both 1st (129.15 +/- 23.6 vs 106.90 +/- 18.6 pmol/L; p=0.01) and 2nd phase (189.42 +/- 34.4 vs 144.21 +/- 37.3 pmol/L; p=0.003) B-cell response to glucose as well as area under the curve (52.07 +/- 10.86 vs 39.54 +/- 10.27 micromol/L x 120'; p=0.005) were greater in R than G groups. Insulin action (4.0 +/- 1.1 vs 3.2 +/- 0.9 mg x Kg x 60'/microU/mL; p=0.046) was also improved by R than G administration. In the meal test, R therapy produced a more rapId induction of insulin secretion during the first part. In fact, the mean rise in insulin secretion peaked at 45 min in R (p=0.001 vs G) and at 60 min in G (p=0.001 vs R). Consequently, glucose spike at 60 min was higher in G group compared to glucose spike at 45 min in R group (p=0.002).
CONCLUSIONS


Our study demonstrates that R is more efficient that G on improving glucose- and meal- induced insulin secretion as well as on controlling for postprandial glucose excursion.",2004,"In fact, the mean rise in insulin secretion peaked at 45 min in R (p=0.001 vs G) and at 60 min in G (p=0.001 vs R).","['14 patients with type 2 diabetes', 'patients with type 2 diabetes']","['naive"" in diet treatment was made', 'Repaglinide', 'Repaglinide vs Glimepiride', 'glimepiride']","['mean rise in insulin secretion', 'Hyperglycemic clamp', 'glucose spike', 'insulin secretion and post-prandial glucose excursions', 'fasting plasma insulin levels', 'Insulin action', 'fasting glucose levels', 'rapId induction of insulin secretion']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0246689', 'cui_str': 'repaglinide'}, {'cui': 'C0061323', 'cui_str': 'glimepiride'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C1256369', 'cui_str': 'Insulin Secretion'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C1276042', 'cui_str': 'Plasma insulin measurement'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C0428548', 'cui_str': 'Glucose level - finding'}]",14.0,0.0174799,"In fact, the mean rise in insulin secretion peaked at 45 min in R (p=0.001 vs G) and at 60 min in G (p=0.001 vs R).","[{'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'Rizzo', 'Affiliation': 'Department of Geriatrics and Metabolic Diseases, Second University of Naples, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Barbieri', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Grella', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Passariello', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Barone', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Paolisso', 'Affiliation': ''}]",Diabetes & metabolism,['10.1016/S1262-3636(07)70093-9']
3676,29955161,Effect of intranasal oxytocin on the core social symptoms of autism spectrum disorder: a randomized clinical trial.,"Although small-scale studies have described the effects of oxytocin on social deficits in autism spectrum disorder (ASD), no large-scale study has been conducted. In this randomized, parallel-group, multicenter, placebo-controlled, double-blind trial in Japan, 106 ASD individuals (18-48 y.o.) were enrolled between Jan 2015 and March 2016. Participants were randomly assigned to a 6-week intranasal oxytocin (48IU/day, n = 53) or placebo (n = 53) group. One-hundred-three participants were analyzed. Since oxytocin reduced the primary endpoint, Autism Diagnostic Observation Schedule (ADOS) reciprocity, (from 8.5 to 7.7; P < .001) but placebo also reduced the score (8.3 to 7.2; P < .001), no between-group difference was found (effect size -0.08; 95% CI, -0.46 to 0.31; P = .69); however, plasma oxytocin was only elevated from baseline to endpoint in the oxytocin-group compared with the placebo-group (effect size -1.12; -1.53 to -0.70; P < .0001). Among the secondary endpoints, oxytocin reduced ADOS repetitive behavior (2.0 to 1.5; P < .0001) compared with placebo (2.0 to 1.8; P = .43) (effect size 0.44; 0.05 to 0.83; P = .026). In addition, the duration of gaze fixation on socially relevant regions, another secondary endpoint, was increased by oxytocin (41.2 to 52.3; P = .03) compared with placebo (45.7 to 40.4; P = .25) (effect size 0.55; 0.10 to 1.0; P = .018). No significant effects were observed for the other secondary endpoints. No significant difference in the prevalence of adverse events was observed between groups, although one participant experienced temporary gynecomastia during oxytocin administration. Based on the present findings, we cannot recommend continuous intranasal oxytocin treatment alone at the current dose and duration for treatment of the core social symptoms of high-functioning ASD in adult men, although this large-scale trial suggests oxytocin's possibility to treat ASD repetitive behavior.",2020,"Among the secondary endpoints, oxytocin reduced ADOS repetitive behavior (2.0 to 1.5; P < .0001) compared with placebo (2.0 to 1.8; P = .43) (effect size 0.44; 0.05 to 0.83; P = .026).","['autism spectrum disorder', 'adult men', 'autism spectrum disorder (ASD', 'One-hundred-three participants were analyzed', 'Japan, 106 ASD individuals (18-48 y.o.) were enrolled between Jan 2015 and March 2016']","['intranasal oxytocin', 'placebo', 'oxytocin']","['plasma oxytocin', 'prevalence of adverse events', 'temporary gynecomastia', 'duration of gaze fixation', 'oxytocin reduced ADOS repetitive behavior', 'Autism Diagnostic Observation Schedule (ADOS) reciprocity']","[{'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C0018418', 'cui_str': 'Male Breast Enlargement'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0553544', 'cui_str': 'Gaze (finding)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}]",103.0,0.68114,"Among the secondary endpoints, oxytocin reduced ADOS repetitive behavior (2.0 to 1.5; P < .0001) compared with placebo (2.0 to 1.8; P = .43) (effect size 0.44; 0.05 to 0.83; P = .026).","[{'ForeName': 'Hidenori', 'Initials': 'H', 'LastName': 'Yamasue', 'Affiliation': 'Department of Psychiatry, Hamamatsu University School of Medicine, 1-20-1 Handayama, Higashiku, Hamamatsu City, 431-3192, Japan. yamasue@hama-med.ac.jp.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Okada', 'Affiliation': 'Department of Psychiatry, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, 466-8550, Japan.'}, {'ForeName': 'Toshio', 'Initials': 'T', 'LastName': 'Munesue', 'Affiliation': 'Research Center for Child Mental Development, Kanazawa University, 13-1 Takara-machi, Kanazawa, 920-8640, Japan.'}, {'ForeName': 'Miho', 'Initials': 'M', 'LastName': 'Kuroda', 'Affiliation': 'Department of Child Neuropsychiatry, School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.'}, {'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Fujioka', 'Affiliation': 'Research Center for Child Mental Development, University of Fukui, Eiheiji, Fukui, 910-1193, Japan.'}, {'ForeName': 'Yota', 'Initials': 'Y', 'LastName': 'Uno', 'Affiliation': 'Department of Psychiatry, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, 466-8550, Japan.'}, {'ForeName': 'Kaori', 'Initials': 'K', 'LastName': 'Matsumoto', 'Affiliation': 'Graduate School of Psychology, Kanazawa Institute of Technology, 7-1 Ohgigaoka, Nonoichi, 921-8054, Japan.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Kuwabara', 'Affiliation': 'Department of Child Neuropsychiatry, School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Mori', 'Affiliation': 'Department of Psychiatry, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, 466-8550, Japan.'}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Okamoto', 'Affiliation': 'Research Center for Child Mental Development, University of Fukui, Eiheiji, Fukui, 910-1193, Japan.'}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Yoshimura', 'Affiliation': 'Research Center for Child Mental Development, Kanazawa University, 13-1 Takara-machi, Kanazawa, 920-8640, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Kawakubo', 'Affiliation': 'Department of Psychiatry, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, 466-8550, Japan.'}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Arioka', 'Affiliation': 'Department of Psychiatry, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, 466-8550, Japan.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Kojima', 'Affiliation': 'Department of Child Neuropsychiatry, School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.'}, {'ForeName': 'Teruko', 'Initials': 'T', 'LastName': 'Yuhi', 'Affiliation': 'Research Center for Child Mental Development, Kanazawa University, 13-1 Takara-machi, Kanazawa, 920-8640, Japan.'}, {'ForeName': 'Keiho', 'Initials': 'K', 'LastName': 'Owada', 'Affiliation': 'Department of Child Neuropsychiatry, School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.'}, {'ForeName': 'Walid', 'Initials': 'W', 'LastName': 'Yassin', 'Affiliation': 'Department of Child Neuropsychiatry, School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.'}, {'ForeName': 'Itaru', 'Initials': 'I', 'LastName': 'Kushima', 'Affiliation': 'Department of Psychiatry, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, 466-8550, Japan.'}, {'ForeName': 'Seico', 'Initials': 'S', 'LastName': 'Benner', 'Affiliation': 'Department of Child Neuropsychiatry, School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.'}, {'ForeName': 'Nanayo', 'Initials': 'N', 'LastName': 'Ogawa', 'Affiliation': 'Department of Psychiatry, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, 466-8550, Japan.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Eriguchi', 'Affiliation': 'Department of Child Neuropsychiatry, School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.'}, {'ForeName': 'Naoko', 'Initials': 'N', 'LastName': 'Kawano', 'Affiliation': 'Department of Psychiatry, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, 466-8550, Japan.'}, {'ForeName': 'Yukari', 'Initials': 'Y', 'LastName': 'Uemura', 'Affiliation': 'Biostatistics Division, Clinical Research Support Center, University of Tokyo Hospital, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.'}, {'ForeName': 'Maeri', 'Initials': 'M', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Psychiatry, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, 466-8550, Japan.'}, {'ForeName': 'Yukiko', 'Initials': 'Y', 'LastName': 'Kano', 'Affiliation': 'Department of Child Neuropsychiatry, School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.'}, {'ForeName': 'Kiyoto', 'Initials': 'K', 'LastName': 'Kasai', 'Affiliation': 'Department of Neuropsychiatry, School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.'}, {'ForeName': 'Haruhiro', 'Initials': 'H', 'LastName': 'Higashida', 'Affiliation': 'Research Center for Child Mental Development, Kanazawa University, 13-1 Takara-machi, Kanazawa, 920-8640, Japan.'}, {'ForeName': 'Norio', 'Initials': 'N', 'LastName': 'Ozaki', 'Affiliation': 'Department of Psychiatry, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, 466-8550, Japan.'}, {'ForeName': 'Hirotaka', 'Initials': 'H', 'LastName': 'Kosaka', 'Affiliation': 'Research Center for Child Mental Development, University of Fukui, Eiheiji, Fukui, 910-1193, Japan.'}]",Molecular psychiatry,['10.1038/s41380-018-0097-2']
3677,31668914,Effects of strengthening the hip flexor muscles on walking ability and the locomotive syndrome rank test: An intervention study.,"BACKGROUND


Locomotive syndrome is a state in which locomotive function is decreased due to musculoskeletal diseases. To extend a healthy lifespan, it is important to prevent falls and locomotive syndrome development accompanying aging by slowing the decline in walking ability. However, it is unclear whether hip flexor muscle strengthening improves walking ability and locomotive syndrome. This study aimed to examine the effect of hip flexor muscle strengthening on walking ability and the locomotive syndrome rank test.
METHODS


Forty participants were enrolled. Before hip flexor muscle strengthening, maximum muscle strength on the exercised side was measured, and gait analysis and the two-step test were performed simultaneously. Participants were divided into a healthy group and a locomotive syndrome group based on the two-step test and were given hip flexor muscle training at least three days a week for six weeks. After completing the training, maximum muscle strength was measured and gait analysis was performed for all participants. The difference between the two-step test conducted pre- and post-training in the locomotive syndrome group was statistically analyzed.
RESULTS


Twenty-two and 14 participants were included in the healthy and the locomotive syndrome groups, respectively. Hip flexion strength on the exercised side increased from 1.68 to 1.95 Nm/kg (p < 0.0001) and 1.04 to 1.21 Nm/kg (p = 0.0031) in the healthy and the locomotive syndrome groups, respectively. Step length, stride length and walking speed measured by gait analysis also increased in both groups. Consequently, the two-step test score improved from 1.17 to 1.30 (p = 0.0002) and the stage of locomotive syndrome improved in 9 participants (p = 0.041).
CONCLUSIONS


Strengthening of the hip flexor muscles improved walking ability and the stage of locomotive syndrome. Therefore, strengthening of the hip flexor muscles is important for the prevention and improvement of locomotive syndrome.",2020,"Hip flexion strength on the exercised side increased from 1.68 to 1.95 Nm/kg (p < 0.0001) and 1.04 to 1.21 Nm/kg (p = 0.0031) in the healthy and the locomotive syndrome groups, respectively.","['Twenty-two and 14 participants were included in the healthy and the locomotive syndrome groups, respectively', 'Forty participants were enrolled']","['hip flexor muscle strengthening', 'strengthening the hip flexor muscles', 'locomotive syndrome group based on the two-step test and were given hip flexor muscle training']","['stage of locomotive syndrome', 'walking ability and the locomotive syndrome rank test', 'walking ability', 'Step length, stride length and walking speed measured by gait analysis', 'walking ability and locomotive syndrome', 'maximum muscle strength', 'Hip flexion strength']","[{'cui': 'C4284772', 'cui_str': '22 (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4087189', 'cui_str': 'Locomotive syndrome'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C4087189', 'cui_str': 'Locomotive syndrome'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087028', 'cui_str': 'Step Test'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C4087189', 'cui_str': 'Locomotive syndrome'}, {'cui': 'C0559964', 'cui_str': 'Ambulation ability'}, {'cui': 'C0699794', 'cui_str': 'Rank (attribute)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0427126', 'cui_str': 'Step length (observable entity)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0558820', 'cui_str': 'Gait Analysis'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}]",40.0,0.0293889,"Hip flexion strength on the exercised side increased from 1.68 to 1.95 Nm/kg (p < 0.0001) and 1.04 to 1.21 Nm/kg (p = 0.0031) in the healthy and the locomotive syndrome groups, respectively.","[{'ForeName': 'Hisatomo', 'Initials': 'H', 'LastName': 'Sato', 'Affiliation': 'Department of Physical and Rehabilitation Medicine, Advanced Medical Professional Training Course, Osaka Medical College Graduate School of Medicine Department of Rehabilitation, Japan; Osaka Medical College Hospital, Japan. Electronic address: reh041@osaka-med.ac.jp.'}, {'ForeName': 'Shusuke', 'Initials': 'S', 'LastName': 'Kondo', 'Affiliation': 'Osaka Medical College Hospital, Japan.'}, {'ForeName': 'Masahisa', 'Initials': 'M', 'LastName': 'Saito', 'Affiliation': 'School of Health Science and Medical Care, Meiji University of Integrative Medicine, Japan.'}, {'ForeName': 'Ryuichi', 'Initials': 'R', 'LastName': 'Saura', 'Affiliation': 'Department of Physical and Rehabilitation Medicine, Division of Comprehensive Medicine, Osaka Medical College, 569-8686, Japan.'}]",Journal of orthopaedic science : official journal of the Japanese Orthopaedic Association,['10.1016/j.jos.2019.09.014']
3678,31725362,Low-load blood flow restriction training induces similar morphological and mechanical Achilles tendon adaptations compared with high-load resistance training.,"Low-load blood flow restriction (LL-BFR) training has gained increasing interest in the scientific community by demonstrating that increases in muscle mass and strength are comparable to conventional high-load (HL) resistance training. Although adaptations on the muscular level are well documented, there is little evidence on how LL-BFR training affects human myotendinous properties. Therefore, the aim of the present study was to investigate morphological and mechanical Achilles tendon adaptations after 14 wk of strength training. Fifty-five male volunteers (27.9 ± 5.1 yr) were randomly allocated into the following three groups: LL-BFR [20-35% of one-repetition maximum (1RM)], HL (70-85% 1RM), or a nonexercising control (CON) group. The LL-BFR and HL groups completed a resistance training program for 14 wk, and tendon morphology, mechanical as well as material properties, and muscle cross-sectional area (CSA) and isometric strength were assessed before and after the intervention. Both HL (+40.7%) and LL-BFR (+36.1%) training induced significant increases in tendon stiffness ( P  < 0.05) as well as tendon CSA (HL: +4.6%, LL-BFR: +7.8%,  P  < 0.001). These changes were comparable between groups without significant changes in Young's modulus. Furthermore, gastrocnemius medialis muscle CSA and plantar flexor strength significantly increased in both training groups ( P  < 0.05), whereas the CON group did not show significant changes in any of the evaluated parameters. In conclusion, the adaptive change in Achilles tendon properties following low-load resistance training with partial vascular occlusion appears comparable to that evoked by high-load resistance training. NEW & NOTEWORTHY  Low-load blood flow restriction (LL-BFR) training has been shown to induce beneficial adaptations at the muscular level. However, studies examining the effects on human tendon properties are rare. The findings provide first evidence that LL-BFR can increase Achilles tendon mechanical and morphological properties to a similar extent as conventional high-load resistance training. This is of particular importance for individuals who may not tolerate heavy training loads but still aim for improvements in myotendinous function.",2019,"Furthermore, gastrocnemius medialis muscle CSA and plantar flexor strength significantly increased in both training groups ( p  < 0.05), while the CON group did not show significant changes in any of the evaluated parameters.",['Fifty-five male volunteers (27.9 ± 5.1 years'],"['strength training', 'Low-load blood flow restriction training', 'HL (70-85% 1RM) or a non-exercising control group (CON', 'LL-BFR', 'Low-load blood flow restriction (LL-BFR) training', 'CON']","['tendon stiffness', 'LL-BFR', 'Furthermore, gastrocnemius medialis muscle CSA and plantar flexor strength']","[{'cui': 'C0450382', 'cui_str': '55 (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0042950', 'cui_str': 'Will'}]","[{'cui': 'C0039508', 'cui_str': 'Tendons'}, {'cui': 'C0427008', 'cui_str': 'Stiffness (finding)'}, {'cui': 'C0042950', 'cui_str': 'Will'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0258591', 'cui_str': 'cyclosporin A, 4-(2-butenyl)-4,4,N-trimethylthreonine(1)-'}, {'cui': 'C0442036', 'cui_str': 'Plantar (qualifier value)'}]",55.0,0.0158298,"Furthermore, gastrocnemius medialis muscle CSA and plantar flexor strength significantly increased in both training groups ( p  < 0.05), while the CON group did not show significant changes in any of the evaluated parameters.","[{'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Centner', 'Affiliation': 'Department of Sport and Sport Science, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Benedikt', 'Initials': 'B', 'LastName': 'Lauber', 'Affiliation': 'Department of Sport and Sport Science, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Olivier R', 'Initials': 'OR', 'LastName': 'Seynnes', 'Affiliation': 'Department of Physical Performance, Norwegian School of Sport Sciences, Oslo, Norway.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Jerger', 'Affiliation': 'Department of Sport and Sport Science, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Sohnius', 'Affiliation': 'Department of Sport and Sport Science, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Gollhofer', 'Affiliation': 'Department of Sport and Sport Science, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'König', 'Affiliation': 'Department of Sport and Sport Science, University of Freiburg, Freiburg, Germany.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00602.2019']
3679,31144258,"Randomized comparison of McGrath MAC videolaryngoscope, Pentax Airway Scope, and Macintosh direct laryngoscope for nasotracheal intubation in patients with manual in-line stabilization.","BACKGROUND


The objective of this study was to determine the clinical usefulness of videolaryngoscopes (VLs) by comparing the time to intubation (TTI) and the ease of intubation of McGrath MAC VL (MVL), Pentax Airway Scope VL (PVL), and Macintosh direct laryngoscope (DL) during nasotracheal intubation using manual in-line stabilization to simulate difficult airways.
METHODS


One hundred and twenty patients were randomly assigned to the MVL group (n = 40), the PVL group (n = 40), and the DL group (n = 40). Nasotracheal intubation was performed using MVL, PVL, or DL, according to group assignments. The primary outcome was TTI and secondary outcomes were glottic view, ease of intubation, and bleeding.
RESULTS


The TTI was significantly shorter in the MVL group than in the DL group (45 sec vs 57 sec; difference in means: - 12; 95% confidence interval [CI], - 21 to - 3; P = 0.01). The percentage of glottic opening and Cormack Lehane grade were significantly superior in the MVL and the PVL groups compared with the DL group (both P < 0.001). The intubation difficulty scale and numeric rating scale regarding ease of intubation were also significantly lower in the MVL and PVL groups than in the DL group (all P < 0.007). The incidence of bleeding was significantly lower in the MVL group than in the DL group (3 vs 15, relative risk 0.2; 95% CI, 0.06 to 0.64; P = 0.001).
CONCLUSION


This study showed that both MVL and PVL provided better visualization of the glottis and easier intubation, with less additional manipulation than DL during nasotracheal intubation in simulated difficult airways. Additionally, use of the MVL significantly shortened the TTI compared with the DL.
TRIAL REGISTRATION


www.clinicaltrials.gov (NCT02647606); registered 6 January, 2016.",2019,The intubation difficulty scale and numeric rating scale regarding ease of intubation were also significantly lower in the MVL and PVL groups than in the DL group (all P < 0.007).,"['One hundred and twenty patients', 'patients with manual in-line stabilization']","['MVL and PVL', 'McGrath MAC VL (MVL), Pentax Airway Scope VL (PVL), and Macintosh direct laryngoscope (DL', 'PVL', 'McGrath MAC videolaryngoscope, Pentax Airway Scope, and Macintosh direct laryngoscope', 'Nasotracheal intubation', 'videolaryngoscopes (VLs', 'MVL']","['TTI and secondary outcomes were glottic view, ease of intubation, and bleeding', 'intubation difficulty scale and numeric rating scale regarding ease of intubation', 'percentage of glottic opening and Cormack Lehane grade', 'incidence of bleeding']","[{'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}]","[{'cui': 'C0009545', 'cui_str': 'C5b-9'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0180453', 'cui_str': 'Laryngoscopes'}, {'cui': 'C3164607', 'cui_str': 'Videolaryngoscope (physical object)'}, {'cui': 'C0396625', 'cui_str': 'Nasotracheal intubation (procedure)'}]","[{'cui': 'C0761034', 'cui_str': 'tsetse thrombin inhibitor'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0222045'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}]",120.0,0.103555,The intubation difficulty scale and numeric rating scale regarding ease of intubation were also significantly lower in the MVL and PVL groups than in the DL group (all P < 0.007).,"[{'ForeName': 'Go Un', 'Initials': 'GU', 'LastName': 'Roh', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, CHA Bundang Medical Center, CHA University School of Medicine, Bundang CHA General Hospital, Seongnam, Korea.'}, {'ForeName': 'Hyun Jeong', 'Initials': 'HJ', 'LastName': 'Kwak', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Gachon University, Gil Medical Center, Incheon, Korea.'}, {'ForeName': 'Kyung Cheon', 'Initials': 'KC', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Gachon University, Gil Medical Center, Incheon, Korea.'}, {'ForeName': 'Sun Young', 'Initials': 'SY', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, CHA Bundang Medical Center, CHA University School of Medicine, Bundang CHA General Hospital, Seongnam, Korea.'}, {'ForeName': 'Jong Yeop', 'Initials': 'JY', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine, 164, World cup-ro, Yeongtong-gu, Suwon, 16499, Korea. kjyeop@ajou.ac.kr.'}]",Canadian journal of anaesthesia = Journal canadien d'anesthesie,['10.1007/s12630-019-01409-5']
3680,31100455,Efficacy of Epicutaneous Immunotherapy in Children With Milk-Induced Eosinophilic Esophagitis.,"BACKGROUND & AIMS


Eosinophilic esophagitis (EoE) is caused by an immune response to specific food allergens. There are no approved therapies beyond avoidance of the allergen(s) or treatment of inflammation. Epicutaneous immunotherapy (EPIT) reduces features of eosinophilic gastrointestinal disease in mice and pigs. We performed randomized, placebo-controlled study to determine the safety and efficacy of EPIT with Viaskin milk in children with milk-induced EoE.
METHODS


In a double-blind study, 20 children (4-17 years old) with milk-induced EoE were randomly assigned to groups given EPIT with Viaskin milk (n = 15) or placebo (n = 5) for 9 months during a milk-free period, followed by milk-containing diet for 2 months with EPIT. Then, subjects underwent upper endoscopy analysis, biopsies were collected, and maximum esophageal eosinophil counts were determined and was the primary endpoint. After upper endoscopy, patients were given open-label EPIT for 11 months (open-label phase). The subjects were allowed to consume milk if they had maximum values of fewer than 10 eosinophils/high-power field (eos/hpf); otherwise, they remained on a milk-free diet until the last 2 months of the open-label phase.
RESULTS


In the intent to treat population, there was no significant difference between the Viaskin milk group in mean eos/hpf (50.1 ± 43.97 eos/hpf) vs the placebo group (48.20 ± 56.98 eos/hpf). However, in the per-protocol population (7 patients given Viaskin milk and 2 patients given placebo), patients given Viaskin milk patients had a significantly lower mean eos/hpf count (25.57 ± 31.19) than patients given placebo (95.00 ± 63.64) (p = .038). At the end of the open-label phase, 9 of 19 evaluable subjects had mean values of fewer than 15 eos/hpf (47% response). The number of adverse events did not differ significantly between the Viaskin milk and placebo groups; there was 1 serious adverse event in the placebo group.
CONCLUSIONS


In a pilot study of pediatric patients with EoE given EPIT with Viaskin milk or placebo for 11 months, we found no significant difference between groups for the maximum eosinophil count at the end of the study. However, findings from a per-protocol analysis indicate that Viaskin milk can reduce eos/hpf. At study completion, 47% of patients who continued open-label Viaskin milk for an additional 11 months had mean values of fewer than 15 eos/hpf. ClinicalTrials.gov no: NCT02579876.",2020,"The number of adverse events did not differ significantly between the Viaskin milk and placebo groups; there was 1 serious adverse event in the placebo group.
","['children with milk-induced EoE', 'mice and pigs', 'Children with Milk-Induced Eosinophilic Esophagitis', 'pediatric patients with EoE given EPIT with Viaskin milk or', '20 children (4-17 years old) with milk-induced EoE']","['Epicutaneous immunotherapy (EPIT', 'placebo', 'open-label EPIT', 'Epicutaneous Immunotherapy', 'EPIT with Viaskin milk']","['maximum esophageal eosinophil counts', 'safety and efficacy', 'eosinophilic gastrointestinal disease', 'maximum eosinophil count', 'number of adverse events']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0026809', 'cui_str': 'Mice'}, {'cui': 'C0039005', 'cui_str': 'Pigs'}, {'cui': 'C0341106', 'cui_str': 'Chronic Esophagitis, Eosinophilic'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0021083', 'cui_str': 'Immunotherapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0026131', 'cui_str': 'Milk'}]","[{'cui': 'C0200638', 'cui_str': 'Eosinophil count - observation'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0017178', 'cui_str': 'Gastrointestinal Diseases'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",20.0,0.295666,"The number of adverse events did not differ significantly between the Viaskin milk and placebo groups; there was 1 serious adverse event in the placebo group.
","[{'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Spergel', 'Affiliation': ""Division of Allergy and Immunology, Children's Hospital of Philadelphia, Pennsylvania; Department of Pediatrics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania. Electronic address: spergel@email.chop.edu.""}, {'ForeName': 'Okan U', 'Initials': 'OU', 'LastName': 'Elci', 'Affiliation': ""Westat, Rockville MD; Biostatistics and Data Management Core, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.""}, {'ForeName': 'Amanda B', 'Initials': 'AB', 'LastName': 'Muir', 'Affiliation': ""Department of Pediatrics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania; Division of Gastroenterology, Hepatology, and Nutrition, Children's Hospital of Philadelphia, Pennsylvania.""}, {'ForeName': 'Chris A', 'Initials': 'CA', 'LastName': 'Liacouras', 'Affiliation': ""Department of Pediatrics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania; Division of Gastroenterology, Hepatology, and Nutrition, Children's Hospital of Philadelphia, Pennsylvania.""}, {'ForeName': 'Benjamin J', 'Initials': 'BJ', 'LastName': 'Wilkins', 'Affiliation': ""Department of Pathology and Laboratory Medicine, Children's Hospital of Philadelphia, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.""}, {'ForeName': 'Deirdre', 'Initials': 'D', 'LastName': 'Burke', 'Affiliation': ""Division of Allergy and Immunology, Children's Hospital of Philadelphia, Pennsylvania.""}, {'ForeName': 'Megan O', 'Initials': 'MO', 'LastName': 'Lewis', 'Affiliation': ""Division of Allergy and Immunology, Children's Hospital of Philadelphia, Pennsylvania.""}, {'ForeName': 'Terri', 'Initials': 'T', 'LastName': 'Brown-Whitehorn', 'Affiliation': ""Division of Allergy and Immunology, Children's Hospital of Philadelphia, Pennsylvania; Department of Pediatrics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.""}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Cianferoni', 'Affiliation': ""Division of Allergy and Immunology, Children's Hospital of Philadelphia, Pennsylvania; Department of Pediatrics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.""}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2019.05.014']
3681,31740723,Oxytocin reduces the functional connectivity between brain regions involved in eating behavior in men with overweight and obesity.,"BACKGROUND


Oxytocin (OXT), shown to decrease food intake in animal models and men, is a promising novel treatment for obesity. We have shown that in men with overweight and obesity, intranasal (IN) OXT reduced the functional magnetic resonance imaging (fMRI) blood oxygenation level-dependent signal in the ventral tegmental area (VTA), the origin of the mesolimbic dopaminergic reward system, in response to high-calorie food vs. nonfood images. Here, we employed functional connectivity fMRI analysis, which measures the synchrony in activation between neural systems in a context-dependent manner. We hypothesized that OXT would attenuate the functional connectivity of the VTA with key food motivation brain areas only when participants viewed high-calorie food stimuli.
METHODS


This randomized, double-blind, and placebo-controlled crossover study of 24 IU IN OXT included ten men with overweight or obesity (mean ± SEM BMI: 28.9 ± 0.8 kg/m 2 ). Following drug administration, subjects completed an fMRI food motivation paradigm including images of high and low-calorie foods, nonfood objects, and fixation stimuli. A psychophysiological interaction analysis was performed with the VTA as seed region.
RESULTS


Following OXT administration, compared with placebo, participants exhibited significantly attenuated functional connectivity between the VTA and the insula, oral somatosensory cortex, amygdala, hippocampus, operculum, and middle temporal gyrus in response to viewing high-calorie foods (Z ≥ 3.1, cluster-corrected, p < 0.05). There was no difference in functional connectivity between VTA and these brain areas when comparing OXT and placebo for low-calorie food, nonfood, and fixation images.
CONCLUSION


In men with overweight and obesity, OXT attenuates the functional connectivity between the VTA and food motivation brain regions in response to high-calorie visual food images. These findings could partially explain the observed anorexigenic effect of OXT, providing insight into the mechanism through which OXT ameliorates food cue-induced reward anticipation in patients with obesity. Additional studies are ongoing to further delineate the anorexigenic effect of OXT in obesity.",2020,"Following OXT administration, compared with placebo, participants exhibited significantly attenuated functional connectivity between the VTA and the insula, oral somatosensory cortex, amygdala, hippocampus, operculum, and middle temporal gyrus in response to viewing high-calorie foods (Z ≥ 3.1, cluster-corrected, p < 0.05).","['men with overweight and obesity', 'ten men with overweight or obesity (mean\u2009±\u2009SEM BMI: 28.9\u2009±\u20090.8\u2009kg/m 2 ', 'men with overweight and obesity, intranasal (IN', 'patients with obesity']","['OXT', '24 IU IN OXT', 'placebo', 'Oxytocin', 'OXT and placebo', 'Oxytocin (OXT']","['insula, oral somatosensory cortex, amygdala, hippocampus, operculum, and middle temporal gyrus in response to viewing high-calorie foods', 'functional connectivity']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}]","[{'cui': 'C0021640', 'cui_str': 'Insula of Reil'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0037658', 'cui_str': 'Somatosensory Cortex'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid Body'}, {'cui': 'C0949582', 'cui_str': 'Seahorses'}, {'cui': 'C0228262', 'cui_str': 'Operculum structure'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0442043', 'cui_str': 'Temporal (qualifier value)'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C0453831', 'cui_str': 'High energy food (substance)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]",,0.191194,"Following OXT administration, compared with placebo, participants exhibited significantly attenuated functional connectivity between the VTA and the insula, oral somatosensory cortex, amygdala, hippocampus, operculum, and middle temporal gyrus in response to viewing high-calorie foods (Z ≥ 3.1, cluster-corrected, p < 0.05).","[{'ForeName': 'Liya', 'Initials': 'L', 'LastName': 'Kerem', 'Affiliation': 'Neuroendocrine Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Nouchine', 'Initials': 'N', 'LastName': 'Hadjikhani', 'Affiliation': 'Athinoula A. Martinos Center for Biomedical Imaging, Department of Radiology, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Holsen', 'Affiliation': ""Division of Women's Health, Department of Medicine and Department of Psychiatry, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Lawson', 'Affiliation': 'Neuroendocrine Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA. ealawson@partners.org.'}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Plessow', 'Affiliation': 'Neuroendocrine Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA. fplessow@mgh.harvard.edu.'}]",International journal of obesity (2005),['10.1038/s41366-019-0489-7']
3682,31868799,Protocol on transcranial alternating current stimulation for the treatment of major depressive disorder: a randomized controlled trial.,"BACKGROUND


Transcranial alternating current stimulation (tACS) offers a new approach for adult patients with major depressive disorder (MDD). The study is to evaluate the efficacy and safety of tACS treating MDD.
METHODS


This is an 8-week, double-blind, randomized, placebo-controlled study. Ninety-two drug-naive patients with MDD aged 18 to 65 years will receive 20 daily 40-min, 77.5-Hz, 15-mA sessions of active or sham tACS targeting the forehead and both mastoid areas on weekdays for 4 consecutive weeks (week 4), following a 4-week observation period (week 8). The primary outcome is the remission rate defined as the 17-item Hamilton depression rating scale (HDRS-17) score ≤7 at week 8. Secondary outcomes are the rates of response at weeks 4 and 8 and rate of remission at week 4 based on HDRS-17, the proportion of participants having improvement in the clinical global impression-improvement, the change in HDRS-17 score (range, 0-52, with higher scores indicating more depression) over the study, and variations of brain imaging and neurocognition from baseline to week 4. Safety will be assessed by vital signs at weeks 4 and 8, and adverse events will be collected during the entire study.
DISCUSSION


The tACS applied in this trial may have treatment effects on MDD with minimal side effects.
TRIAL REGISTRATION


Chinese Clinical Trial Registry, ChiCTR1800016479; http://www.chictr.org.cn/showproj.aspx?proj=22048.",2019,The primary outcome is the remission rate defined as the 17-item Hamilton depression rating scale (HDRS-17) score ≤7 at week 8.,"['major depressive disorder', 'Ninety-two drug-naive patients with MDD aged 18 to 65 years', 'adult patients with major depressive disorder (MDD']","['placebo', 'transcranial alternating current stimulation', 'Transcranial alternating current stimulation (tACS', '20 daily 40-min, 77.5-Hz, 15-mA sessions of active or sham tACS']","['clinical global impression-improvement, the change in HDRS-17 score', 'remission rate defined as the 17-item Hamilton depression rating scale (HDRS-17) score', 'rates of response at weeks 4 and 8 and rate of remission', 'efficacy and safety']","[{'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3852966', 'cui_str': 'Transcranial Alternating Current Stimulation'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",92.0,0.347202,The primary outcome is the remission rate defined as the 17-item Hamilton depression rating scale (HDRS-17) score ≤7 at week 8.,"[{'ForeName': 'Hong-Xing', 'Initials': 'HX', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Beijing Puren Hospital, Beijing 100062, China.'}, {'ForeName': 'Wen-Rui', 'Initials': 'WR', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Wen-Feng', 'Initials': 'WF', 'LastName': 'Zhao', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Xiao-Tong', 'Initials': 'XT', 'LastName': 'Yang', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Mao', 'Initials': 'M', 'LastName': 'Peng', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Zhi-Chao', 'Initials': 'ZC', 'LastName': 'Sun', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Xue', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Jia', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Dong', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Shu-Qin', 'Initials': 'SQ', 'LastName': 'Zhan', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Bao-Quan', 'Initials': 'BQ', 'LastName': 'Min', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Chun-Qiu', 'Initials': 'CQ', 'LastName': 'Fan', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Ai-Hong', 'Initials': 'AH', 'LastName': 'Zhou', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Hai-Qing', 'Initials': 'HQ', 'LastName': 'Song', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Yin', 'Affiliation': 'Medical Research & Biometrics Centre, National Centre for Cardiovascular Diseases, Beijing 102300, China.'}, {'ForeName': 'Tian-Mei', 'Initials': 'TM', 'LastName': 'Si', 'Affiliation': 'Peking University Sixth Hospital, Beijing 100083, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Department of Radiology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': 'Department of Radiology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Hai-Xia', 'Initials': 'HX', 'LastName': 'Leng', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Wei-Jun', 'Initials': 'WJ', 'LastName': 'Ding', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Tian-Yi', 'Initials': 'TY', 'LastName': 'Yan', 'Affiliation': 'School of Life Science, Beijing Institute of Technology, Beijing 100081, China.'}, {'ForeName': 'Yu-Ping', 'Initials': 'YP', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}]",Chinese medical journal,['10.1097/CM9.0000000000000589']
3683,31760958,Five salmon dinners per week were not sufficient to prevent the reduction in serum vitamin D in autumn at 60° north latitude: a randomised trial.,"Low serum concentrations of several vitamins have been linked to increased risk of diseases including insulin resistance and type 2 diabetes (T2D). Fish is a good source of several vitamins, and the prevalence of T2D is low in populations with high fish intake. The aim of the present study was to investigate the effects of high fish intake on vitamins in serum from adults in autumn in South-Western Norway at 60° north latitude. In this randomised clinical trial, sixty-three healthy participants with overweight/obesity consumed 750 g/week of either cod (n 22) or salmon (n 22) as five weekly dinners or were instructed to continue their normal eating habits but avoid fish intake (Control group, n 19) for 8 weeks. The estimated vitamin D intake was significantly increased in the Salmon group when compared with the Cod group (P = 6·3 × 10-4) and with the Control group (P = 3·5 × 10-6), with no differences between groups for estimated intake of vitamins A, B1, B2, B3, B6, B9, C and E. Serum 25-hydroxyvitamin D3 concentration was decreased in all groups after 8 weeks; however, the reduction in the Salmon group was significantly smaller compared with the Cod group (P = 0·013) and the Control group (P = 0·0060). Cod and salmon intake did not affect serum concentrations of the other measured vitamins. The findings suggest that 750 g/week of salmon was not sufficient to prevent a decrease in serum 25-hydroxyvitamin D3 in autumn in South-Western Norway in adults with overweight/obesity.",2020,"The estimated vitamin D intake was significantly increased in the Salmon group when compared to the Cod group (P=6.3x10-4) and to the Control group (P=3.5x10-6), while for vitamins A, B1, B2, B3, B6, B9, C and E, no differences in estimated intake were found between groups.","['adults with overweight/obesity in autumn in South-Western Norway at 60º north latitude', 'sixty-three healthy participants with overweight/obesity consumed 750 g/week of either cod (N=22) or salmon (N=22) as 5 weekly dinners, or', 'adults with overweight/obese']","['were instructed to continue their normal eating habits but avoid fish intake (Control group', 'cod or salmon']","['serum vitamin D', 'estimated vitamin D intake', 'Serum 25-hydroxyvitamin D3 concentration', 'serum concentrations', 'serum 25-hydroxyvitamin D3']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0028423', 'cui_str': 'Kingdom of Norway'}, {'cui': 'C4319614', 'cui_str': '63 (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C4517868', 'cui_str': '750 (qualifier value)'}, {'cui': 'C0556978', 'cui_str': 'g/week'}, {'cui': 'C0459207', 'cui_str': 'Cod'}, {'cui': 'C0036110', 'cui_str': 'Salmon'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C4552592', 'cui_str': 'With dinner'}]","[{'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0556216', 'cui_str': 'Fish intake (observable entity)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0459207', 'cui_str': 'Cod'}, {'cui': 'C0036110', 'cui_str': 'Salmon'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0564439', 'cui_str': 'Vitamin D intake (observable entity)'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",63.0,0.0580852,"The estimated vitamin D intake was significantly increased in the Salmon group when compared to the Cod group (P=6.3x10-4) and to the Control group (P=3.5x10-6), while for vitamins A, B1, B2, B3, B6, B9, C and E, no differences in estimated intake were found between groups.","[{'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Bratlie', 'Affiliation': 'Dietary Protein Research Group, Department of Clinical Medicine, University of Bergen, 5021 Bergen, Norway.'}, {'ForeName': 'Ingrid V', 'Initials': 'IV', 'LastName': 'Hagen', 'Affiliation': 'Dietary Protein Research Group, Department of Clinical Medicine, University of Bergen, 5021 Bergen, Norway.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Helland', 'Affiliation': 'Dietary Protein Research Group, Department of Clinical Medicine, University of Bergen, 5021 Bergen, Norway.'}, {'ForeName': 'Øivind', 'Initials': 'Ø', 'LastName': 'Midttun', 'Affiliation': 'Bevital AS, Jonas Lies veg 87, 5021 Bergen, Norway.'}, {'ForeName': 'Arve', 'Initials': 'A', 'LastName': 'Ulvik', 'Affiliation': 'Bevital AS, Jonas Lies veg 87, 5021 Bergen, Norway.'}, {'ForeName': 'Grethe', 'Initials': 'G', 'LastName': 'Rosenlund', 'Affiliation': 'Skretting Aquaculture Research Centre AS, P.O. Box 48, 4001 Stavanger, Norway.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Sveier', 'Affiliation': 'Lerøy Seafood Group ASA, P.O. Box 7600, 5020 Bergen, Norway.'}, {'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Mellgren', 'Affiliation': 'Mohn Nutrition Research Laboratory, Department of Clinical Science, University of Bergen, Haukeland University Hospital, 5021 Bergen, Norway.'}, {'ForeName': 'Per Magne', 'Initials': 'PM', 'LastName': 'Ueland', 'Affiliation': 'Bevital AS, Jonas Lies veg 87, 5021 Bergen, Norway.'}, {'ForeName': 'Oddrun A', 'Initials': 'OA', 'LastName': 'Gudbrandsen', 'Affiliation': 'Dietary Protein Research Group, Department of Clinical Medicine, University of Bergen, 5021 Bergen, Norway.'}]",The British journal of nutrition,['10.1017/S0007114519002964']
3684,31954186,"Effects of aquatic exercise on insulin-like growth factor-1, brain-derived neurotrophic factor, vascular endothelial growth factor, and cognitive function in elderly women.","The purpose of this study was to investigate the effects of a 16-week aquatic exercise program on brain-derived neurotrophic factor (BDNF), insulin-like growth factor-1 (IGF-1), and vascular endothelial growth factor (VEGF) levels, as well as cognitive function in elderly women. The subjects were 20 elderly women aged 68-80 years, randomly divided into an aquatic exercise group (n = 10) and a control group (n = 10). The aquatic exercises were performed for 60 min, three times per week for 16 weeks, and the intensity was progressively increased every 4 weeks (40-50% of heart rate reserve (HRR) for weeks 1-4, 50-60% of HRR for weeks 5-8, 60-65% of HRR for weeks 9-12, and 65-70% of HRR for weeks 13-16). The data were analyzed using two-way repeated measures analysis of variance, paired t-test, and independent t-test with an alpha level to indicate significance set at.05 for all tests. After the 16-week aquatic exercise program, the BDNF and IGF-1 levels (p < .01, respectively), and cognitive function (p < .05) of the aquatic exercise group showed significant changes. BDNF, IGF-1, and cognitive function levels (p < .01, respectively) were significantly different between the aquatic exercise group and control group. The results of this study suggest that regular aquatic exercise in elderly women during the early stages of aging can increase the expression of BDNF and IGF-1, thus maintaining and improving cognitive function.",2020,"After the 16-week aquatic exercise program, the BDNF and IGF-1 levels (p < .01, respectively), and cognitive function (p < .05) of the aquatic exercise group showed significant changes.","['elderly women', 'subjects were 20 elderly women aged 68-80\u202fyears']","['aquatic exercise program', 'aquatic exercise', 'aquatic exercise group', 'regular aquatic exercise']","['insulin-like growth factor-1, brain-derived neurotrophic factor, vascular endothelial growth factor, and cognitive function', 'BDNF, IGF-1, and cognitive function levels', 'BDNF and IGF-1 levels', 'expression of BDNF and IGF-1, thus maintaining and improving cognitive function', 'brain-derived neurotrophic factor (BDNF), insulin-like growth factor-1 (IGF-1), and vascular endothelial growth factor (VEGF) levels', 'cognitive function']","[{'cui': 'C0524338', 'cui_str': 'Elderly woman (person)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}]","[{'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}]",20.0,0.018323,"After the 16-week aquatic exercise program, the BDNF and IGF-1 levels (p < .01, respectively), and cognitive function (p < .05) of the aquatic exercise group showed significant changes.","[{'ForeName': 'Doo-Wang', 'Initials': 'DW', 'LastName': 'Kang', 'Affiliation': 'Department of Physical Education, Pusan National University, Busan, South Korea.'}, {'ForeName': 'Eadric', 'Initials': 'E', 'LastName': 'Bressel', 'Affiliation': 'Department of Kinesiology and Health Science, Utah State University, Logan, UT, USA.'}, {'ForeName': 'Do-Yeon', 'Initials': 'DY', 'LastName': 'Kim', 'Affiliation': 'Department of Physical Education, Pusan National University, Busan, South Korea. Electronic address: kdy4955@pusan.ac.kr.'}]",Experimental gerontology,['10.1016/j.exger.2020.110842']
3685,31916789,Effects of a universal classroom management teacher training program on elementary children with aggressive behaviors.,"The purpose of this study was to examine the treatment effects of the Incredible Years Teacher Classroom Management (IY TCM), a universal classroom management intervention, on the outcomes of children with aggressive behavior in elementary school. Classroom management has been demonstrated as a factor in either escalating children's aggressive behavior or decreasing those problematic behaviors. Participants included 1,817 students (Grade K to 3) and 105 teachers from nine elementary schools in a large urban Midwestern school district. Teachers were randomly assigned to receive IY TCM or to a wait-list comparison group. The hypotheses were that baseline levels of aggression would moderate the relationship between intervention status and outcomes. Findings indicated the hypothesized moderation effect on several outcome variables; specifically, children with baseline aggression problems who were in IY TCM classrooms had significantly improved math achievement, emotional regulation, prosocial behaviors, and observed aggression in comparison to similar peers in the control classrooms. Implications for practice and future research based on the findings are discussed. (PsycINFO Database Record (c) 2020 APA, all rights reserved).",2020,Teachers were randomly assigned to receive IY TCM or to a wait-list comparison group.,"['elementary children with aggressive behaviors', 'children with aggressive behavior in elementary school', 'Participants included 1,817 students (Grade K to 3) and 105 teachers from nine elementary schools in a large urban Midwestern school district']","['universal classroom management teacher training program', 'Incredible Years Teacher Classroom Management (IY TCM), a universal classroom management intervention', 'TCM']","['math achievement, emotional regulation, prosocial behaviors, and observed aggression']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001807', 'cui_str': 'Aggression'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}]","[{'cui': 'C0175671', 'cui_str': 'Universal (qualifier value)'}, {'cui': 'C4082803', 'cui_str': 'Teacher Training'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}]","[{'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C3875135', 'cui_str': 'Observes (attribute)'}, {'cui': 'C0001807', 'cui_str': 'Aggression'}]",2020.0,0.020769,Teachers were randomly assigned to receive IY TCM or to a wait-list comparison group.,"[{'ForeName': 'Chi-Ching', 'Initials': 'CC', 'LastName': 'Chuang', 'Affiliation': 'Faculty Affairs Office, Okinawa Institute of Science and Technology Graduate University.'}, {'ForeName': 'Wendy M', 'Initials': 'WM', 'LastName': 'Reinke', 'Affiliation': 'Department of Educational, School and Counseling Psychology, University of Missouri.'}, {'ForeName': 'Keith C', 'Initials': 'KC', 'LastName': 'Herman', 'Affiliation': 'Department of Educational, School and Counseling Psychology, University of Missouri.'}]","School psychology (Washington, D.C.)",['10.1037/spq0000351']
3686,31842191,ROBOT-ASSISTED VITREORETINAL SURGERY IMPROVES SURGICAL ACCURACY COMPARED WITH MANUAL SURGERY: A Randomized Trial in a Simulated Setting.,"PURPOSE


To compare manual and robot-assisted vitreoretinal surgery using a virtual-reality surgical simulator.
METHODS


Randomized controlled crossover study. Ten experienced vitreoretinal surgeons and 10 novice ophthalmic surgeons were included. The participants were randomized to start with either manual or robot-assisted surgery. Participants completed a test session consisting of three vitreoretinal modules on the Eyesi virtual-reality simulator. The automated metrics of performance supplied by the Eyesi simulator were used as outcome measures. Primary outcome measures were time with instruments inserted (seconds), instrument movement (mm), and tissue treatment (mm).
RESULTS


Robot-assisted surgery was slower than manual surgery for both novices and vitreoretinal surgeons, 0.24 SD units (P = 0.024) and 0.73 SD units (P < 0.001), respectively. Robot-assisted surgery allowed for greater precision in novices and vitreoretinal surgeons, -0.96 SD units (P < 0.001) and -0.47 SD units (P < 0.001), respectively. Finally, novices using robot-assisted surgery inflicted less tissue damage when compared with that using manual surgery, -0.59 SD units (P = 0.009).
CONCLUSION


At the cost of time, robot-assisted vitreoretinal surgery seems to improve precision and limit tissue damage compared with that of manual surgery. In particular, the performance of novice surgeons is enhanced with robot-assisted vitreoretinal surgery.",2020,"Robot-assisted surgery allowed for greater precision in novices and vitreoretinal surgeons, -0.96 SD units (P < 0.001) and -0.47 SD units (P < 0.001), respectively.",['Ten experienced vitreoretinal surgeons and 10 novice ophthalmic surgeons'],"['manual and robot-assisted vitreoretinal surgery', 'Robot-assisted surgery', 'robot-assisted vitreoretinal surgery', 'manual or robot-assisted surgery']","['time with instruments inserted (seconds), instrument movement (mm), and tissue treatment (mm', 'tissue damage', 'precision and limit tissue damage']","[{'cui': 'C1720040', 'cui_str': 'Vitreoretinal surgeon'}, {'cui': 'C0260073', 'cui_str': 'Ophthalmic surgeon (occupation)'}]","[{'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0336537', 'cui_str': 'Robot, device (physical object)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C2936205', 'cui_str': 'Vitreoretinal Surgery'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C4551823', 'cui_str': 'instruments'}, {'cui': 'C1881217', 'cui_str': 'Insert - unit of product usage'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0010957', 'cui_str': 'Damage (morphologic abnormality)'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}]",10.0,0.286633,"Robot-assisted surgery allowed for greater precision in novices and vitreoretinal surgeons, -0.96 SD units (P < 0.001) and -0.47 SD units (P < 0.001), respectively.","[{'ForeName': 'Mads', 'Initials': 'M', 'LastName': 'Forslund Jacobsen', 'Affiliation': 'Department of Ophthalmology, Rigshospitalet, Glostrup, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Konge', 'Affiliation': 'Copenhagen Academy for Medical Education and Simulation, Centre for HR, Capital Region of Denmark, Copenhagen, Denmark.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Alberti', 'Affiliation': 'Department of Ophthalmology, Rigshospitalet, Glostrup, Denmark.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'la Cour', 'Affiliation': 'Department of Ophthalmology, Rigshospitalet, Glostrup, Denmark.'}, {'ForeName': 'Yoon Soo', 'Initials': 'YS', 'LastName': 'Park', 'Affiliation': 'Department of Medical Education, University of Illinois, Chicago, Illinois.'}, {'ForeName': 'Ann Sofia Skou', 'Initials': 'ASS', 'LastName': 'Thomsen', 'Affiliation': 'Department of Ophthalmology, Rigshospitalet, Glostrup, Denmark.'}]","Retina (Philadelphia, Pa.)",['10.1097/IAE.0000000000002720']
3687,31784194,[Benzoletter: minimal intervention for deprescribing benzodiazepines in patients with insomnia].,"OBJECTIVE


To determine whether a letter-based intervention to patients taking benzodiazepines reduces their consumption.
METHOD


A before-after study without control group performed in primary care in May 2016. 1582 patients who took a single daily dose of benzodiazepines as hypnotic for more than 3 months were sent a personalized letter from their family doctor. The letter contained information about the risks of long-term benzodiazepine consumption and the recommendation to discontinue them with a gradual drop protocol (Benzoletter). The percentage of patients who stopped or decreased the use of benzodiazepines, and the difference in the total dose dispensed (mg equivalents of diazepam dispensed in three months) between the pre- and post-intervention period (at 6 and 12 months) were evaluated.
RESULTS


Dispensing data from 1561 patients were collected (average age: 69.3 years; 74% women). Twelve months after the intervention, 22.0% (95% confidence interval [95%CI]: 19.9-24.0) discontinued benzodiazepine consumption and 18.8% (95%CI: 16.9-20.8) reduced their consumption. A statistically significant reduction was observed in the total dose dispensed (mean difference: 89mg; 95%CI: 72.2-105.7).
CONCLUSION


The Benzoletter is associated with a significant decrease in the consumption of hypnotics. It is a simple and feasible intervention that allows acting on large populations, and it could even be periodically repeated. Controlled studies are required to confirm its effectiveness.",2020,"The percentage of patients who stopped or decreased the use of benzodiazepines, and the difference in the total dose dispensed (mg equivalents of diazepam dispensed in three months) between the pre- and post-intervention period (at 6 and 12 months) were evaluated.
","['1582 patients who took a single daily dose of', 'patients with insomnia', '1561 patients were collected (average age: 69.3 years; 74% women']","['diazepam', 'benzodiazepines', 'letter-based intervention']",['consumption of hypnotics'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0012010', 'cui_str': 'Diazepam'}, {'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}, {'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0020591', 'cui_str': 'Hypnotics'}]",1582.0,0.0628752,"The percentage of patients who stopped or decreased the use of benzodiazepines, and the difference in the total dose dispensed (mg equivalents of diazepam dispensed in three months) between the pre- and post-intervention period (at 6 and 12 months) were evaluated.
","[{'ForeName': 'Mikel', 'Initials': 'M', 'LastName': 'Baza Bueno', 'Affiliation': 'Osakidetza, OSI Bilbao-Basurto, Centro de Salud Begoña, Bilbao, España; Laboratorio del Polimedicado (http://polimedicado.org/), Bilbao, España. Electronic address: mikelbaza@gmail.com.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Ruiz de Velasco Artaza', 'Affiliation': 'Osakidetza, OSI Bilbao-Basurto, Servicio de Farmacia, Bilbao, España.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Fernández Uria', 'Affiliation': 'Osakidetza, OSI Bilbao-Basurto, Servicio de Farmacia, Bilbao, España.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Gorroñogoitia Iturbe', 'Affiliation': 'Osakidetza, Unidad Docente Multiprofesional Atención Familiar y Comunitaria de Bizkaia, Bilbao, España.'}]",Gaceta sanitaria,['10.1016/j.gaceta.2019.06.012']
3688,31168938,Dulaglutide-combined basal plus correction insulin therapy contributes to ideal glycemic control in non-critical hospitalized patients.,"AIMS/INTRODUCTION


We investigated whether dulaglutide (DU)-combined conventional insulin therapy is beneficial for glycemic control in non-critically ill hospitalized patients with type 2 diabetes.
MATERIALS AND METHODS


This study was a prospective, randomized controlled pilot study. Participants were randomized to either basal-plus (BP) therapy, where basal insulin and corrective doses of regular insulin were administered before meals, or BP + DU therapy, where BP therapy was combined with DU. Blood glucose (BG) levels before and after every meal were measured for 7 days after assignment to groups. Because we consider the ideal BG during hospitalization to be within 100-180 mg/dL, we defined this range as the hospitalized ideal glucose range (hIGR). We compared the percentage of BG measurements within the hIGR among all BG measurements (%hIGR), mean BG, glucose variability and insulin dose between the two groups.
RESULTS


Of 54 patients, 27 were assigned to the BP group and 27 to the BP + DU group. The %hIGR was significantly higher (44% vs 56%, P < 0.001), and the frequency of BG >240 mg/dL and BG <70 mg/dL was significantly lower in the BP + DU group than in the BP group (both P < 0.001). The mean BG (183 ± 29 vs 162 ± 30 mg/dL, P < 0.05), standard deviation (P < 0.01), coefficient of variation (P < 0.01) and total regular insulin dose (P < 0.05) in the BP + DU group were significantly lower than those in the BP group. No significant side-effects were observed in either group.
CONCLUSIONS


BP + DU therapy reduced the frequency of hyperglycemia and hypoglycemia, and resulted in a lower glucose variability.",2020,"The %hIGR was significantly higher (44% vs 56%, P < 0.001), and the frequency of BG","['non-critical hospitalized patients', '30', 'non-critically ill hospitalized patients with type\xa02 diabetes', '54 patients']","['\xa0DU therapy', 'Dulaglutide-combined basal plus correction insulin therapy', 'dulaglutide (DU)-combined conventional insulin therapy', 'basal-plus (BP) therapy, where basal insulin and corrective doses of regular insulin were administered before meals, or BP\xa0+\xa0DU therapy, where BP therapy was combined with DU']","['BP', 'frequency of BG', 'side-effects', 'Blood glucose (BG) levels', 'BP\xa0', 'standard deviation', 'coefficient of variation (P', 'frequency of hyperglycemia and hypoglycemia', 'mean BG, glucose variability and insulin dose', 'total regular insulin dose (P', 'percentage of BG measurements']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3179549', 'cui_str': 'dulaglutide'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0021641', 'cui_str': 'Insulin, Regular'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C1550738', 'cui_str': 'Before meal (qualifier value)'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0428554', 'cui_str': 'Blood glucose result - finding'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0021641', 'cui_str': 'Insulin, Regular'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}]",,0.0483136,"The %hIGR was significantly higher (44% vs 56%, P < 0.001), and the frequency of BG","[{'ForeName': 'Nobutoshi', 'Initials': 'N', 'LastName': 'Fushimi', 'Affiliation': 'Department of Endocrinology and Diabetes, Ichinomiyanishi Hospital, Aichi, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Shibuya', 'Affiliation': 'Department of Endocrinology and Diabetes, Ichinomiyanishi Hospital, Aichi, Japan.'}, {'ForeName': 'Yohei', 'Initials': 'Y', 'LastName': 'Yoshida', 'Affiliation': 'Department of Endocrinology and Diabetes, Ichinomiyanishi Hospital, Aichi, Japan.'}, {'ForeName': 'Shun', 'Initials': 'S', 'LastName': 'Ito', 'Affiliation': 'Department of Endocrinology and Diabetes, Ichinomiyanishi Hospital, Aichi, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Hachiya', 'Affiliation': 'Department of Endocrinology and Diabetes, Ichinomiyanishi Hospital, Aichi, Japan.'}, {'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Mori', 'Affiliation': 'Department of Endocrinology and Diabetes, Ichinomiyanishi Hospital, Aichi, Japan.'}]",Journal of diabetes investigation,['10.1111/jdi.13093']
3689,31961377,Association of Default Electronic Medical Record Settings With Health Care Professional Patterns of Opioid Prescribing in Emergency Departments: A Randomized Quality Improvement Study.,"Importance


Prescription opioids play a significant role in the ongoing opioid crisis. Guidelines and physician education have had mixed success in curbing opioid prescriptions, highlighting the need for other tools that can change prescriber behavior, including nudges based in behavioral economics.
Objective


To determine whether and to what extent changes in the default settings in the electronic medical record (EMR) are associated with opioid prescriptions for patients discharged from emergency departments (EDs).
Design, Setting, and Participants


This quality improvement study randomly altered, during a series of five 4-week blocks, the prepopulated dispense quantities of discharge prescriptions for commonly prescribed opioids at 2 large, urban EDs. These changes were made without announcement, and prescribers were not informed of the study itself. Participants included all health care professionals (physicians, nurse practitioners, and physician assistants) working clinically in either of the 2 EDs. Data were collected from November 28, 2016, through July 9, 2017, and analyzed from July 16, 2017, through May 14, 2018.
Interventions


Default quantities for opioids were changed from status quo quantities of 12 and 20 tablets to null, 5, 10, and 15 tablets according to a block randomization scheme. Regardless of the default quantity, each health care professional decided for whom to prescribe opioids and could modify the quantity prescribed without restriction.
Main Outcomes and Measures


The primary outcome was the number of tablets of opioid-containing medications prescribed under each default setting.
Results


A total of 104 health care professionals wrote 4320 prescriptions for opioids during the study period. Using linear regression, an increase of 0.19 tablets prescribed (95% CI, 0.15-0.22) was found for each tablet increase in default quantity. When evaluating each of the 15 pairwise comparisons of default quantities (eg, 5 vs 15 tablets), a lower default was associated with a lower number of pills prescribed in more than half (8 of the 15) of the pairwise comparisons; there was a higher quantity in 1 and no difference in 6 comparisons.
Conclusions and Relevance


These findings suggest that default settings in the EMR may influence the quantity of opioids prescribed by health care professionals. This low-cost, easily implementable, EMR-based intervention could have far-reaching implications for opioid prescribing and could be used as a tool to help combat the opioid epidemic.
Trial Registration


ClinicalTrials.gov identifier: NCT04155229.",2020,"Using linear regression, an increase of 0.19 tablets prescribed (95% CI, 0.15-0.22) was found for each tablet increase in default quantity.","['Data were collected from November 28, 2016, through July 9, 2017, and analyzed from July 16, 2017, through May 14, 2018', '104 health care professionals wrote 4320 prescriptions for opioids during the study period', 'patients discharged from emergency departments (EDs', 'Participants included all health care professionals (physicians, nurse practitioners, and physician assistants) working clinically in either of the 2 EDs', 'Emergency Departments']",[],['number of tablets of opioid-containing medications prescribed under each default setting'],"[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C4517776', 'cui_str': 'Four thousand three hundred and twenty'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0030685', 'cui_str': 'Patient Discharge'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0028657', 'cui_str': 'Nurse practitioner (occupation)'}, {'cui': 'C0031833', 'cui_str': ""Physicians' Extenders""}, {'cui': 'C0043227', 'cui_str': 'Work'}]",[],"[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C2239117', 'cui_str': 'Drug Prescribing'}]",,0.171444,"Using linear regression, an increase of 0.19 tablets prescribed (95% CI, 0.15-0.22) was found for each tablet increase in default quantity.","[{'ForeName': 'Juan Carlos C', 'Initials': 'JCC', 'LastName': 'Montoy', 'Affiliation': 'Department of Emergency Medicine, University of California, San Francisco.'}, {'ForeName': 'Zlatan', 'Initials': 'Z', 'LastName': 'Coralic', 'Affiliation': 'Department of Emergency Medicine, University of California, San Francisco.'}, {'ForeName': 'Andrew A', 'Initials': 'AA', 'LastName': 'Herring', 'Affiliation': 'Department of Emergency Medicine, Highland Hospital-Alameda Health System, Oakland, California.'}, {'ForeName': 'Eben J', 'Initials': 'EJ', 'LastName': 'Clattenburg', 'Affiliation': 'Department of Emergency Medicine, Highland Hospital-Alameda Health System, Oakland, California.'}, {'ForeName': 'Maria C', 'Initials': 'MC', 'LastName': 'Raven', 'Affiliation': 'Department of Emergency Medicine, University of California, San Francisco.'}]",JAMA internal medicine,['10.1001/jamainternmed.2019.6544']
3690,31880966,Randomized Phase III Study of Continuation Maintenance Bevacizumab With or Without Pemetrexed in Advanced Nonsquamous Non-Small-Cell Lung Cancer: COMPASS (WJOG5610L).,"PURPOSE


Patients with non-small-cell lung cancer (NSCLC) have been shown to benefit from maintenance therapy. COMPASS evaluated the efficacy and safety of bevacizumab with or without pemetrexed as continuation maintenance therapy after carboplatin, pemetrexed, and bevacizumab induction therapy.
PATIENTS AND METHODS


Patients with untreated advanced nonsquamous NSCLC without confirmed  EGFR  19 deletion or L858R mutation received first-line therapy with carboplatin area under the curve 6, pemetrexed 500 mg/m 2 , and bevacizumab 15 mg/kg once every 3 weeks for 4 cycles. Patients without disease progression during the induction therapy were randomly assigned 1:1 for maintenance therapy with pemetrexed 500 mg/m 2  plus bevacizumab 15 mg/kg or bevacizumab 15 mg/kg once every 3 weeks until disease progression or unacceptable toxicity. The primary end point was overall survival (OS) after random assignment.
RESULTS


Between September 2010 and September 2015, 907 patients received induction therapy. Of those, 599 were randomly assigned: 298 received pemetrexed plus bevacizumab, and 301 received bevacizumab. The median OS was 23.3  v  19.6 months (hazard ratio [HR], 0.87; 95% CI, 0.73 to 1.05; 1-sided stratified log-rank  P  = .069). In the wild-type  EGFR  subset, the OS HR was 0.82 (95% CI, 0.68 to 0.99; 1-sided unstratified log-rank  P  = .020). The median progression-free survival (PFS) was 5.7  v  4.0 months (HR, 0.67; 95% CI, 0.57 to 0.79; 2-sided log-rank  P  < .001). The safety data were consistent with previous reports of treatment regimens.
CONCLUSION


In terms of the primary end point of OS, no statistically significant benefit was observed; however, PFS in the total patient population and OS in patients with wild-type  EGFR  was prolonged with the addition of pemetrexed to bevacizumab maintenance therapy.",2020,"In terms of the primary end point of OS, no statistically significant benefit was observed; however, PFS in the total patient population and OS in patients with wild-type  EGFR  was prolonged with the addition of pemetrexed to bevacizumab maintenance therapy.","['Advanced Nonsquamous Non-Small-Cell Lung Cancer', 'Patients with non-small-cell lung cancer (NSCLC', 'Patients without disease progression during the induction therapy', 'Between September 2010 and September 2015', '907 patients received', 'Patients with untreated advanced nonsquamous NSCLC without confirmed  EGFR  19 deletion or L858R mutation received']","['first-line therapy with carboplatin area under the curve 6, pemetrexed 500 mg/m 2 , and bevacizumab', 'pemetrexed plus bevacizumab', 'maintenance therapy with pemetrexed 500 mg/m 2  plus bevacizumab 15 mg/kg or bevacizumab', 'carboplatin, pemetrexed, and bevacizumab induction therapy', 'bevacizumab with or without pemetrexed', 'induction therapy', 'bevacizumab', 'Continuation Maintenance Bevacizumab With or Without Pemetrexed']","['median progression-free survival (PFS', 'efficacy and safety', 'median OS', 'PFS', 'overall survival (OS']","[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C1442161', 'cui_str': 'Deletion (morphologic abnormality)'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}]","[{'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C4074670', 'cui_str': 'pemetrexed 500 MG'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0210657', 'cui_str': 'pemetrexed'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",907.0,0.199467,"In terms of the primary end point of OS, no statistically significant benefit was observed; however, PFS in the total patient population and OS in patients with wild-type  EGFR  was prolonged with the addition of pemetrexed to bevacizumab maintenance therapy.","[{'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Seto', 'Affiliation': 'National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Azuma', 'Affiliation': 'Kurume University School of Medicine, Kurume, Japan.'}, {'ForeName': 'Takeharu', 'Initials': 'T', 'LastName': 'Yamanaka', 'Affiliation': 'Yokohama City University, Yokohama, Japan.'}, {'ForeName': 'Shunichi', 'Initials': 'S', 'LastName': 'Sugawara', 'Affiliation': 'Sendai Kousei Hospital, Sendai, Japan.'}, {'ForeName': 'Hiroshige', 'Initials': 'H', 'LastName': 'Yoshioka', 'Affiliation': 'Kansai Medical University Hospital, Hirakata, Japan.'}, {'ForeName': 'Kazushige', 'Initials': 'K', 'LastName': 'Wakuda', 'Affiliation': 'Shizuoka Cancer Center, Shizuoka, Japan.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Atagi', 'Affiliation': 'Department of Internal Medicine, National Hospital Organization Kinki-Chuo Chest Medical Center, Sakai, Japan.'}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Iwamoto', 'Affiliation': 'Hiroshima Citizens Hospital, Hiroshima, Japan.'}, {'ForeName': 'Hidetoshi', 'Initials': 'H', 'LastName': 'Hayashi', 'Affiliation': 'Kindai University Faculty of Medicine, Osaka, Japan.'}, {'ForeName': 'Isamu', 'Initials': 'I', 'LastName': 'Okamoto', 'Affiliation': 'Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Hideo', 'Initials': 'H', 'LastName': 'Saka', 'Affiliation': 'National Hospital Organization, Nagoya Medical Center, Nagoya, Japan.'}, {'ForeName': 'Shigeki', 'Initials': 'S', 'LastName': 'Mitsuoka', 'Affiliation': 'Osaka City University Hospital, Osaka, Japan.'}, {'ForeName': 'Daichi', 'Initials': 'D', 'LastName': 'Fujimoto', 'Affiliation': 'Kobe City Medical Center General Hospital, Kobe, Japan.'}, {'ForeName': 'Kazumi', 'Initials': 'K', 'LastName': 'Nishino', 'Affiliation': 'Osaka International Cancer Institute, Osaka, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Horiike', 'Affiliation': 'The Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.'}, {'ForeName': 'Haruko', 'Initials': 'H', 'LastName': 'Daga', 'Affiliation': 'Osaka City General Hospital, Osaka, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Sone', 'Affiliation': 'Kanazawa University Hospital, Kanazawa, Japan.'}, {'ForeName': 'Nobuyuki', 'Initials': 'N', 'LastName': 'Yamamoto', 'Affiliation': 'Wakayama Medical University, Wakayama, Japan.'}, {'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Nakagawa', 'Affiliation': 'Kindai University Hospital, Osaka, Japan.'}, {'ForeName': 'Yoichi', 'Initials': 'Y', 'LastName': 'Nakanishi', 'Affiliation': 'Kyushu University Hospital, Fukuoka, Japan.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.01494']
3691,31444542,Comparison of crevicular fluid cytokine levels after the application of surface sealants : A randomized trial.,"PURPOSE


Surface sealants are widely used in orthodontic practice to avoid enamel decalcifications in patients treated with fixed orthodontic appliances. While their clinical benefit was tested in several studies, their biocompatibility has been evaluated to a lesser extent. Therefore, the aim of this randomized prospective study was to evaluate possible adverse biological effects of three commonly used surface sealants and a bonding primer on gingival tissues by analysing cytokines in crevicular fluid of orthodontic patients after the application of surface sealants.
METHODS


A single centre parallel trial was conducted. Using a split-mouth design quadrants of 15 patients requiring orthodontic treatment with fixed appliances were randomized to one of three commonly used surface sealants (Pro Seal®, Opal®Seal™, Protecto®CaF2Nano) and a bonding primer (Transbond™ XT). Interleukin (IL)-8 and IL-10 levels in crevicular fluids of the individual quadrants were assessed at four different time points (before application, and at 30, 60 and 90 min after application).
RESULTS


In all, 60 quadrants of 15 patients were randomized (Pro Seal® n = 15, Opal®Seal™ n = 15, Protecto®CaF2Nano n = 15, Transbond™ XT n = 15) and analysed. No significant changes for IL-8 or IL-10 levels in crevicular fluid after the application of surface sealants or bonding primer were detected. However, interpatient variability was high. No further clinical side effects were detected.
CONCLUSIONS


Commonly used pre-bonding surface sealants (Pro Seal®, Opal®Seal™) do not appear to have a significant impact on inflammatory cytokines levels of crevicular fluid and do not appear to contribute to sensitization or hypersensitivity events.",2019,No significant changes for IL-8 or IL-10 levels in crevicular fluid after the application of surface sealants or bonding primer were detected.,"['60\xa0quadrants of 15\xa0patients were', 'surface sealants ', 'crevicular fluid of orthodontic patients after the application of surface sealants', 'patients treated with fixed orthodontic appliances', '15\xa0patients requiring orthodontic treatment with fixed appliances']","['randomized (Pro Seal® n\u202f=\u200915, Opal®Seal™ n\u202f=\u200915, Protecto®CaF2Nano n\u202f=\u200915, Transbond™ XT', 'surface sealants (Pro Seal®, Opal®Seal™, Protecto®CaF2Nano) and a\xa0bonding primer (Transbond™ XT', 'Interleukin']","['crevicular fluid cytokine levels', 'clinical side effects', 'IL-8 or IL-10 levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C1261530', 'cui_str': 'Sealant (substance)'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0029335', 'cui_str': 'Orthodontics'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0441421', 'cui_str': 'Permanent Retainer'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1570472', 'cui_str': 'Pro Seal'}, {'cui': 'C0036492', 'cui_str': 'Seal (organism)'}, {'cui': 'C0613830', 'cui_str': 'Protecto'}, {'cui': 'C0084815', 'cui_str': 'Transbond'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C1261530', 'cui_str': 'Sealant (substance)'}, {'cui': 'C0028758', 'cui_str': 'Object Relationship'}, {'cui': 'C0021764', 'cui_str': 'Interleukins'}]","[{'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}]",,0.295406,No significant changes for IL-8 or IL-10 levels in crevicular fluid after the application of surface sealants or bonding primer were detected.,"[{'ForeName': 'Sinan', 'Initials': 'S', 'LastName': 'Şen', 'Affiliation': 'Department of Orthodontics and Dentofacial Orthopaedics, Dental School, University of Heidelberg, Im Neuenheimer Feld\xa0400, 69120, Heidelberg, Germany. sinan.sen@med.uni-heidelberg.de.'}, {'ForeName': 'Gül', 'Initials': 'G', 'LastName': 'Orhan', 'Affiliation': 'Department of Orthodontics and Dentofacial Orthopaedics, Dental School, University of Heidelberg, Im Neuenheimer Feld\xa0400, 69120, Heidelberg, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Zingler', 'Affiliation': 'Department of Orthodontics and Dentofacial Orthopaedics, Dental School, University of Heidelberg, Im Neuenheimer Feld\xa0400, 69120, Heidelberg, Germany.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Katsikogianni', 'Affiliation': 'Department of Orthodontics and Dentofacial Orthopaedics, Dental School, University of Heidelberg, Im Neuenheimer Feld\xa0400, 69120, Heidelberg, Germany.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Lux', 'Affiliation': 'Department of Orthodontics and Dentofacial Orthopaedics, Dental School, University of Heidelberg, Im Neuenheimer Feld\xa0400, 69120, Heidelberg, Germany.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Erber', 'Affiliation': 'Department of Orthodontics and Dentofacial Orthopaedics, Dental School, University of Heidelberg, Im Neuenheimer Feld\xa0400, 69120, Heidelberg, Germany.'}]",Journal of orofacial orthopedics = Fortschritte der Kieferorthopadie : Organ/official journal Deutsche Gesellschaft fur Kieferorthopadie,['10.1007/s00056-019-00184-8']
3692,31225625,Potential Moderating Effects of Sex/Gender on the Acute Relative Reinforcing and Subjective Effects of Reduced Nicotine Content Cigarettes in Vulnerable Populations.,"INTRODUCTION


Reports in relatively healthy smokers suggest men are more sensitive than women to the subjective effects of reduced nicotine content cigarettes (RNCCs). We know of no reports examining sex differences in the relative reinforcing effects of RNCCs, an important outcome in assessing smoking's addiction potential. The aim of the present study is to address this gap by examining sex/gender differences on reinforcing effects while examining whether sex differences in subjective effects are discernible in vulnerable populations.
METHODS


Secondary analysis of a within-subject, double-blinded experiment examining acute effects of cigarettes varying in nicotine content (0.4, 2.4, 5.2, 15.8 mg/g) among 169 adult smokers with psychiatric conditions or socioeconomic disadvantage. Effects of dose, sex, and their interaction were examined on reinforcing (concurrent-choice and Cigarette Purchase Task [CPT] testing), and subjective effects (Cigarette Evaluation Questionnaire [CEQ] and craving/withdrawal ratings).
RESULTS


Reducing nicotine content decreased the relative reinforcing effects of smoking in concurrent-choice and CPT testing (p's < .05) with no significant effects of sex nor dose × sex/gender interactions. Reducing nicotine content decreased CEQ ratings with only a single significant effect of sex (higher Psychological Reward scores among women than men, p = .02) and no significant dose × sex/gender interactions. Results on craving/withdrawal paralleled those on the CEQ.
CONCLUSIONS


Reducing nicotine content decreases the addiction potential of smoking independent of sex in populations highly vulnerable to smoking and addiction, with no indication that women are less sensitive to subjective effects of RNCCs or would benefit less from a policy reducing the nicotine content of cigarettes.
IMPLICATIONS


A policy reducing the nicotine content of cigarettes has the potential to reduce the addiction potential of smoking across men and women who are especially vulnerable to smoking, addiction, and tobacco-related adverse health impacts.",2020,"RESULTS


Reducing nicotine content decreased the relative reinforcing effects of smoking in concurrent-choice and CPT testing (p's < .05) with no significant effects of sex nor dose-by-sex/gender interactions.","['Vulnerable Populations', 'healthy smokers suggest men', 'Secondary analysis of a within-subject, double-blind experiment examining acute effects of cigarettes varying in nicotine content (0.4, 2.4, 5.2, 15.8 mg/g) among 169 adult smokers with psychiatric conditions or socioeconomic disadvantage']",['Nicotine Content Cigarettes'],"['CEQ ratings', 'reinforcing (concurrent-choice and Cigarette Purchase Task (CPT) testing), and subjective effects (Cigarette Evaluation Questionnaire (CEQ) and craving/withdrawal ratings']","[{'cui': 'C0949366', 'cui_str': 'Vulnerable Populations'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C4517457', 'cui_str': 'Zero point four'}, {'cui': 'C4517631', 'cui_str': '2.4 (qualifier value)'}, {'cui': 'C4517790', 'cui_str': '5.2 (qualifier value)'}, {'cui': 'C1300563', 'cui_str': 'ug/mg'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0012613', 'cui_str': 'Disadvantaged'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}]","[{'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0870371', 'cui_str': 'Craving'}]",169.0,0.0258027,"RESULTS


Reducing nicotine content decreased the relative reinforcing effects of smoking in concurrent-choice and CPT testing (p's < .05) with no significant effects of sex nor dose-by-sex/gender interactions.","[{'ForeName': 'Joanna M', 'Initials': 'JM', 'LastName': 'Streck', 'Affiliation': 'Vermont Center on Tobacco Regulatory Science, Departments of Psychiatry and Psychological Science, University of Vermont,Burlington, VT.'}, {'ForeName': 'Danielle R', 'Initials': 'DR', 'LastName': 'Davis', 'Affiliation': 'Vermont Center on Tobacco Regulatory Science, Departments of Psychiatry and Psychological Science, University of Vermont,Burlington, VT.'}, {'ForeName': 'Raina D', 'Initials': 'RD', 'LastName': 'Pang', 'Affiliation': 'Department of Preventive Medicine, University of Southern California Keck School of Medicine, Los Angeles, CA.'}, {'ForeName': 'Stacey C', 'Initials': 'SC', 'LastName': 'Sigmon', 'Affiliation': 'Vermont Center on Tobacco Regulatory Science, Departments of Psychiatry and Psychological Science, University of Vermont,Burlington, VT.'}, {'ForeName': 'Janice Y', 'Initials': 'JY', 'LastName': 'Bunn', 'Affiliation': 'Vermont Center on Tobacco Regulatory Science, Departments of Psychiatry and Psychological Science, University of Vermont,Burlington, VT.'}, {'ForeName': 'Cecilia L', 'Initials': 'CL', 'LastName': 'Bergeria', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Jennifer W', 'Initials': 'JW', 'LastName': 'Tidey', 'Affiliation': 'Center for Alcohol and Addiction Studies, Brown University, Providence, RI.'}, {'ForeName': 'Sarah H', 'Initials': 'SH', 'LastName': 'Heil', 'Affiliation': 'Vermont Center on Tobacco Regulatory Science, Departments of Psychiatry and Psychological Science, University of Vermont,Burlington, VT.'}, {'ForeName': 'Diann E', 'Initials': 'DE', 'LastName': 'Gaalema', 'Affiliation': 'Vermont Center on Tobacco Regulatory Science, Departments of Psychiatry and Psychological Science, University of Vermont,Burlington, VT.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Hughes', 'Affiliation': 'Vermont Center on Tobacco Regulatory Science, Departments of Psychiatry and Psychological Science, University of Vermont,Burlington, VT.'}, {'ForeName': 'Maxine L', 'Initials': 'ML', 'LastName': 'Stitzer', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Ellaina', 'Initials': 'E', 'LastName': 'Reed', 'Affiliation': 'Vermont Center on Tobacco Regulatory Science, Departments of Psychiatry and Psychological Science, University of Vermont,Burlington, VT.'}, {'ForeName': 'Stephen T', 'Initials': 'ST', 'LastName': 'Higgins', 'Affiliation': 'Vermont Center on Tobacco Regulatory Science, Departments of Psychiatry and Psychological Science, University of Vermont,Burlington, VT.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz098']